.' J1: 1007 This is to certify that the thesis entitled CHILD RESISTANT DRUG PACKAGING AND ARTHRITIS: CAN OLDER CONSUMERS ACCESS THEIR MEDICATIONS? presented by Eric Yao-Chung Kou has been accepted towards fulfillment of the requirements for the MS. degree in Packaging / Major Prof ssods Signature / Z A7 /a Q: Date MSU is an Affirmative Action/Equal Opportunity Institution LIBRARY Michigan State University .-.- —.----n-.—-—.- . .9- PLACE IN RETURN BOX to remove this checkout from your record. To AVOID FINES return on or before date due. MAY BE RECALLED with earlier due date if requested. DATE DUE DATE DUE DATE DUE R 0 359362343 WOOQZZIHI 2/05 p:IClRC/DateDue.indd—p.1 CHH.D RESISTANT DRUG PACKAGING AND ARTHRITIS: CAN OLDER CONSUMERS ACCESS THEIR MEDICATIONS? By Eric Yao-Chung Kou A THESIS Submitted to Michigan State University in partial fulfilh‘nent of the requirements for the degree of MASTER OF SCIENCE SCHOOL OF PACKAGING 2006 ABSTRACT CHILD RESISTANT DRUG PACKAGING AND ARTHRITIS: CAN OLDER CONSUMERS ACCESS THEIR MEDICATIONS? By Eric Yao-Chung Kou The ability of 100 subjects, 50 with a self-indicated doctor’s diagnosis of arthritis with hand involvement and 50 controls matched for age and gender, to open a variety of types and sizes of child resistant packages was tested. Ninety participants were female and 10 were males. Overall, participants took an average of 7.8 medications daily and 88% of the participants opened their own medications. Over 30% of the subjects were unaware that they could request their medication in non-CR format from the pharmacist. Three types of closure systems (Push and Turn, Squeeze Lok, and Continuous Thread) with different finish sizes were tested for opening, number of successful openings and time to open were the analyzed results. Of the 10 different containers tested, NONE were opened by all subjects. Furthermore, among the 6 child-resistant (CR) containers, 5 containers had 25 or more people fail to open the containers, compared to non-CR containers which had no more than 10 people fail in each of the 4 designs. In addition, participants took on average, a longer time to open the CR containers than the non-CR containers. The shortest mean opening time among the CR containers was approximately 65% longer than the shortest mean opening time among the containers without CR features. The impact of hand strength and size on number of openings, time to open, and time to close was also explored and is discussed. Cepyright by ERIC YAO-CHUNG KOU 2006 ACKNOWLEDGMENTS The author wishes to acknowledge the Center for Food and Pharmaceutical Packaging Research (CFPPR) and the Intramural Research Grants Program (IRGP) for funding this research and Rexam Closures (Clay Robinson and Becki Biever) and Alcan Packaging Plastics America (Jason Melvin) for their generous donations of supplies. The author also wishes to recognize all the education institutes and researchers that supported this research; Michigan State University School of Packaging and the Center for Statistical Training and Consulting (Dr. Laura Bix, Dr. Hugh Lockhart, Dr. Tamara Bush, Dr. Dennis Gilliland, Javier de la F uente, Audrey Whaling, Josh Vincent, Chris Steckler, Irina Murtazashvili, and Xiang Li), Western Michigan University Department of Occupational Therapy (Dr. Debra Lindstrom-Hazel, Kelly Sullivan, and Nancy Kiddy), and Eastern Michigan University Department of Occupational Therapy (Dr. Carolyn Glogoski, and Dr. Michael Chan) Last the author wishes to acknowledge all the data collection sites in State of Michigan that participated in this research; Abbott Parkside Apartments, Friendship Village, Westland Meadows Apartment, River Manor Senior Housing, and Dr. Guggenheim’s Office. TABLE OF CONTENTS LIST OF TABLES ................................................................................. VII LIST OF FIGURES .................................................................................. X INTRODUCTION .................................................................................... 1 CHAPTER 1 HISTORICAL PERSPECTIVE - LAWS AND REGULATIONS ............................. 2 CHAPTER 2 AGING AND DISABILITY AROUND THE WORLD ......................................... 6 CHAPTER 3 ARTHRITIS .......................................................................................... 12 What is Arthritis? ................................................................................................... 13 Why is Arthritis a Public Health Problem? ............................................................ 13 Type of Arthritis ............................................................................ 15 Osteoarthritis ....................................................................... 16 Rheumatoid Arthritis .............................................................. 18 CHAPTER 4 PACKAGING AND PEOPLE WITH ARTHRITIS ........................................... 21 CHAPTER 5 CHILD RESISTANT CONTAINERS IN THE HANDS OF PEOPLE WITHOUT ARTHRITIS .......................................................................................... 23 CHAPTER 6 CHILD POSIONING AND GRANDPARNT CAREGIVERS ............................... 29 CHAPTER 7 NULL HYPOTHESIS .............................................................................. 33 CHAPTER 8 METHODOLOGY ................................................................................. 35 CHAPTER 9 RESULTS AND DISCUSSION .................................................................. 46 Subject Information ........................................................................ 46 Analysis of Strength Information ......................................................... 47 Analysis of Grip Strength ........................................................ 48 Right ........................................................................ 48 Lefi .......................................................................... 49 Analysis of Wrist Strength ....................................................... 50 Right ........................................................................ 50 Left ......................................................................... 5 1 Analysis of Bilateral Squeeze ................................................... 52 Discussion of Strength Data ............................................................... 52 Analysis of Size Information (Anthropometric Data) ................................. 53 Analysis with Packages .................................................................... 54 Statistical Analysis of Data Collected on Package Openings and Closings. . . .61 Split-Plot Design ................................................................... 61 Statistical Analysis of Opening Data ..................................................... 62 Split-Plot Design-Variable Data (Time to Open) ............................ 62 Statistical Analysis of Closing Data ...................................................... 65 Split-Plot Design-Variable Data (Time to Close) ............................. 65 Discussion of Variable Data (Time to Open and Time to Close) .................... 66 Opening Data ...................................................................... 66 Closing Data ........................................................................ 68 Statistical Analysis of Opening Data .................................................... 70 Split-Plot Design-Analysis of the Attribute Data (Package Successfully Opened- Yes or No) ............................................................... 70 Discussion of the Attribute Data (Package Opened Successfully? Package Closed Successfully?) ............................................................................... 72 Survey Data ................................................................................. 75 Discussion of Survey Data ................................................................. 75 CHAPTER 10 CONCLUSION ...................................................................................... 77 CHAPTER 11 RECOMMENDATION AND FUTURE STUDIES ........................................... 81 APPENDICES ....................................................................................... 83 BIBILOGRPAHY ................................................................................. 161 VI LIST OF TABLES Table 1 —- Percent elderly around the world by region and age: 2000 to 2030 ............... 8 Table2—Data collection............... ............................................................ 37 Table 3 — Statistical coding and package ID # ................................................................... 44 Table 4 — Package dimension in mm ............................................................. 44 Table 5 — Breakdown of subjects included in the analysis .................................... 46 Table 6 - Breakdown of medications needed daily by subject ................................ 47 ' Table 7 — Number of people within a category that opened own medications (% of given population opened own medications) .......................................... 47 Table 8 — Average strength of the hand .......................................................... 48 Table 9 —- Result of 2—way ANOVA: Resultant variable is Right Grip Strength-All Effects are considered Fixed Effects ............................................ 48 Table 10 — Analysis of varying effects on Right Grip Strength ............................... 49 Table 11 — Results of 2-way ANOVA: Resultant variable is Left Grip Strength-All Effects are consider Fixed Effects ............................................... 49 Table 12 — Analysis of varying effects on Left Grip Strength ................................. 50 Table 13 — Results of 2-way ANOVA: Resultant variable is Right Wrist Strength—All Effects are considered Fixed Effects ............................................ 50 Table 14 — Analysis of varying effects on Right Wrist Strength ............................. 50 Table 15 — Results of 2-way ANOVA: Resultant variable is Left Wrist Strength-All Effects are considered Fixed Effects ............................................ 51 Table 16 — Analysis of varying effects on Left Wrist Strength ............................... 51 Table 17 — Results of 2-way ANOVA: Resultant variable is Bilateral Squeeze—All Effects are considered Fixed Effects ............................................ 52 Table 18 - Average Functional gn'p diameter (hand digit) in mm ............................ 53 VII Table 19 — Average Hand measurement in mm .................................................. 54 Table 20 - Number of people within a category that could NOT open a given design (% of a given population unable to open a given design) ........................ 55 Table 21 - Average time to open a given design (in seconds) by subject type and packagetype............ ............................................................ 56 Table 22 — Design within each Size that was opened the Most Slowly ..................... 57 Table 23 — Number of people within a category that successfully opened a given closure design (% a given population successfully opened a given closure design) .............................................................................. 58 Table 24 — Average time to close a given design in seconds by subject type and [number of people] ........................................................................ 59 Table 25 —- Design (Within each Size) that was Closed the Most Slowly and [number of people] ............................................................................ 59 Table 26 — Number of people within a category that could NOT close a given design (% of a given population unable to close a given design) ........................ 60 Table 27 — Number of people within a category that successfully closed a given closure design (% of a given population successfully closed a given closure design) .............................................................................. 61 Table 28A — Results of Split Plot: Resultant variable is Time to Open-All Effects are considered Fixed Effects (Size groupings based on Finish Diameters provided by the Bottle Manufacturer) ........................................... 63 Table 28B - Analysis of varying effects on Time to Open (Size groupings based on Finish Diameters provided by the Bottle Manufacturer) ..................... 63 Table 29A — Results of Split Plot: Resultant variable is Time to Open-A11 Effects are considered Fixed Effects (Size groupings based on Outside Diameter of the Closure) ......................................................................... 64 Table 293 — Analysis of varying effects on Time to Open (Size groupings based on Outside Diameter of the Closure) ................................................ 64 Table 30A — Results of Split Plot: Resultant variable is Time to Close-All Effects are considered Fixed Effects (Size groupings based on Finish Diameters provided by the Bottle Manufacturer) .......................................... 65 VIII Table 30B — Analysis of varying effects on Time to Close (Size groupings based on Finish Diameters provided by the Bottle Manufacturer) ..................... 65 Table 31A - Results of Split Plot: Resultant variable is Time to Close-All Effects are considered Fixed Effects (Size groupings based on Outside Diameter of the Closure) ........................................................................ 66 Table 3 1 B - Analysis of varying effects on Time to Close (Size groupings based on Outside Diameter of the Closure) ............................................... 66 Table 32A — Results of Split Plot: Resultant variable is Packaging Successfully Opened- All Effects are considered Fixed Effect (Size groupings based on Finish Diameters provided by the Bottle Manufacturer).......... 71 Table 32B - Analysis of varying effects on Package Successfully Opened (Size groupings based on Finish Diameters provided by the Bottle Manufacturer) ..................................................................... 7 1 Table 33A -— Results of Split Plot: Resultant variable is Packaging Successfully Opened- All Effects are considered Fixed Effect (Size groupings based on Outside Diameter of the Closure) ......................................................... 72 Table 33B - Analysis of varying effects on Package Successfully Opened (Size groupings based on Outside Diameter of the Closure) ....................... 72 Table 34 —- Survey information .................................................................... 75 Table 35 — Number of people within a category who were aware that they could request/purchase medications in non-CR format (% of a given population aware request/purchase medications in non- CR Format) ................... 75 Table 36 — Summary of results for hypotheses based on statistical analysis ............ 77 LIST OF FIGURES Figure 1 — Simplified diagram of the CPSC’s senior adult testing ............................. 5 Figure 2 — Percent aged 65 and over of the total population in US: 2000 to 2050 ......... 6 Figure 3 — Number of people age 65 and over in US, by age group, selected years 1900- 2000 and projected 2010-2050 .................................................... 7 Figure 4 — Percent increase in elderly population around the world: 2000 to 2030 ......... 9 Figure 5 — Selected chronic health conditions causing limitation of activity among adults by age: 1998 to 2000 .............................................................. 10 ' Figure 6 — Disability prevalence by age; Percent with specified level of disability. . . . . ...1 1 Figure 7 — Severe disability distribution by age; Percent distribution of persons with severe disability by age ........................................................... 11 Figure 8 — Top ten most common causes of disability among Americans aged 18 years or older, 1999 .......................................................................... 12 Figure 9 - Annual U.S. burden ................................................................... 13 Figure 10 -— Prevalence of doctor-diagnosed arthritis among US. adults by age group, 2003-2005 .......................................................................... 14 Figure 11 — Projected number of adults with arthritis and arthritis-attributable activity limitations, 2005-2030 ............................................................ 15 Figure 12 — The approximate number of cases in the United States of some common forms of arthritis in 1996 ......................................................... 16 Figure 13 — Areas of the body most frequently impacted by CA ............................. 17 Figure 14 — Osteoarthritis .......................................................................... 18 Figure 15 - Rheumatoid arthritis .................................................................. 19 Figure 16 — Projected prevalence of doctor-diagnosed arthritis, US. adults aged 18+ years, 2005-2030 ................................................................... 20 Figure 17 — Percent of grandparent caregivers by age ......................................... 31 Figure 18 — Percent grandparent caregivers distribution by duration of time responsible ................................................................................................. 3 1 Figure 19 — The containers tested by size ........................................................ 34 Figure 20 — The containers tested ................................................................. 36 Figure 21 — Digital photography (with grid system) ........................................... 38 Figure 22 — J amar® grip dynamometer .......................................................... 39 Figure 23 - Baseline® wrist dynamometer ...................................................... 39 Figure 24 - Baseline® pneumatic squeeze dynamometer ...................................... 40 Figure 25 — Dow coming ophthalmic ............................................................ 41 Figure 26 -— Statistical coding and package ID# ................................................................ 43 Figure 27 — Functional grip diameter measuring cone ......................................... 45 Figure 28 - Average abort time for people unable to open a given package design in seconds ............................................................................. 56 XI INTRODUCTION In 1997 a letter written by a physician named Dr. Lynette Sutherland from the perspective of “a little old lady with arthritis and high blood pressure” was sent to the Canadian Association of Poison Control Centres regarding child resistant (CR) closures. (1) The author stated that although the Canadian Association'of Poison Control Centres believed child resistant closure usage has resulted in a victory in the battle against child- poisoning, that victory didn’t come without a price. “Have we transferred (1 problem from one vulnerable social group to another? In our zeal to protect children, have we inflicted the cost of that protection on elderly people? Has anyone studied scientifically or economically the cost to seniors of the comprehensive use of childproof caps in the drug industry? Do we know how many elderly people have suffered discomfort, disease exacerbation or even death simply because they were unable to open a bottle? [3 society in a net “win ' position as a result of the use of CRCs? Prescription drugs are routinely dispensed with CRCs, and most adults are unaware that they have choice. ‘Muddled ’ seniors are the last people who would be aware of such a choice. There is a good chance they may not think to raise the issue with their physicians or pharmacists and, if some else is monitoring their affairs, they may suffer silently for years. " (1) Researchers from Michigan State University’s School of Packaging hypothesized this same frustration is present in United States. Furthermore in an article from the Wall Street Journal in 2000, a spokesperson from the United State’s Consumer Product Safety Commission (CPSC) made a statement about child-resistant caps indicating, “If older people revolt and leave tops off, we can’t avoid child poisonings.” (2) Study into ease of use and current US. CR packaging is warranted. HISTORICAL PRESEPTIVE - LAWS AND REGULATIONS Over the past several decades, there has been increasingly wide recognition of the problem of accidental poisoning of children. The vast majority of poisoning incidents occur with children aged 0 to 4 years. (3) The poisoning of children as a result of the accidental ingestion of drug products first became a noted problem shortly after the introduction of flavored aspirin in 1943. By 1953, the first Poison Control Center had been established to serve as a central source of information and treatment. This was followed by the establishment of a National Clearinghouse for Poison Control Centers in 195 7. The Clearinghouse was started to coordinate the efforts of local Centers, gather statistical data on poisonings, and provide diagnostic and therapeutic information. (4) In the same year, the proprietary drug industry voluntarily accepted the recommendations of the Medical Advisory Panel on Accidental Ingestion and Misuse of Salicylate Preparations by Children to reduce the strength of children’s aspirin and to limit the number of tablets per package. (4) Efforts to develop “safety closures” were also recommended by the Medical Advisory Panel at this time. In 1959, researchers from Durham, NC reiterated the need to use safety closures for aspirin in an article that appeared in the Journal of the American Medical Association (JAMA). (5) After approximately ten years of hearings, debates, discussion and testing, Public Law 91-601 was enacted on 30 December, 1970 by the US Congress. This law is known as the Poison Prevention Packaging Act (PPPA) of 1970. The act requires pharmaceutical products and hazardous household products to be packaged in “special packaging.” “Special packaging is defined as packaging that is designed or constructed to be significantly difficult for children under 5 years of age to open or obtain a toxic or harmful amount of substance contained therein within a reasonable time, and not difficult for normal adults to use properly, but does not mean packaging which all such children cannot open or obtain a toxic or harmful amount within a reasonable time.” (4) Special packaging is also referred to as child-resistant (CR) packaging. Administration of the PPPA was the responsibility of the Food and Drug Administration (FDA) until October, 1972, when public law 92-573 transferred administrative responsibility to the Consumer Product Safety Commission (CPSC) (3). The CPSC still remains responsible for the regulation of these packages. During the first 25 years of regulation from 1970-1995, package designers were so focused on protecting children from poisoning that they frequently forgot to account for the convenience of the person needing the medication. The effect was the exclusion of many seniors and people with disabilities. This was largely due to the fact that the CPSC protocol for testing CR packages for “senior friendliness” specified that adults aged 18 to 45 years served as subjects for the “senior friendly” portion of the test, and that test subjects must have “no overt physical or mental handicaps.” (6) In actual usage situations, the elderly and people with disabilities had difficulties with CR packages, and frequently circumvented child-resistant features. By the early 19905 the CPSC recognized the need to design a new test protocol and revise the regulation in order to facilitate CR package designs that could be effectively used by older adults. In 1995, the CPSC published new requirements for senior friendly testing. (7) The result was a new protocol that now tests older adults (50 to 70) to measure adult-use effectiveness for CR packages that contain pharmaceuticals. However, the elimination of subjects with “overt physical or mental handicaps” still remains; this is despite the fact that the protocol also includes two screening packages that are intended to exclude people that have significant difficulties. (See Figure 1) Few studies examining the ease of use of CR drug packages have been published since the protocol change took affect January 21, 1998; in 2002, Rahman et a1. looked at the relationship between hand strength and the forces used to access common household containers by well elderly persons. (8) In the US, A. Donaghy et al. (2003) studied patients over the age of 60 to examine their ability to open child resistant closures. (9) In the UK, a series of Government Consumer Safety Research studies on aging related issues on packaging were conducted by the British Department of Trade and Industry in London from the late 19908 until early 2000. (10) As such, purposefully investigating the usability of CR packaging in the hands of older US. consumers becomes increasingly important as the population ages and is more infirm. 100 senior adults 50-70 years old NORMAL ADULT SCREENING People with obvious or overt physical or mental disabilities are excluded «3» C9 5 31'; $13: $3 a «3 I; 1‘ ~3® ~73 6' non-CR non-CR CT closure snap closure e) g t: D 0 \ :1“ ,1 . V E {UNIV-tr. . arwmsutruxmumnm 17‘! ll! - E or U Figure l - Simplified diagram of the CPSC's senior adult testing ggy Source: Reprinted with permission of Javier de la Fuente, from "The use of a universal design SUBJECT EXCLUDED methodology for developing child-resistant drug packaging" (11) AGING AND DISABILITY AROUND THE WORLD After World War 11, there was a period of increased birth rates from the 1946 — 1964. There were over 79 million babies born during this period of time in United States; they are called the Baby Boomers generation. In 2003, nearly 36 million people aged 65 and over lived in the United States. As the age of the Baby Boomers advances, the US. will experience a rapid increase in the elderly population. (12) It is predicted that 20% of the US population will be age 65 or older by 2030 (See Figure 2) and that number will grow to almost 87 million by 2050. Furthermore, those over age 85 will grow from 4.2 million (in 2000) to nearly 21 million by 2050, which will constitute 5% of the population. (1 3) (See Figure 3) Figure 2 - Percent aged 65 and over of the total population in U.S.: 2000 to 2050 I96 20.4 20.6 2000 ZOIO 2020 2030 2040 2050 Source: US. Census Bureau, 65+ in the United States: 2005 (12) 2000, US. Census Bureau, 2001, Table PCT 12; 2010 to 2050, US. Census Bureau, 2004. Figure 3 - Number of people age 65 and over in U.S., by age group, selected years 1900-2000 and projected 2010-2050 Millions 100 - 90 i— ”,1 80 r- // 70 L- ‘ I: 3’ 60 -- l/ / 50 r- KI '/ 4° F’ 65 and over 2'". 30 L- ”"/ If" M’d/ 20 — ,// 10 ... M/ M o ”"1 l 1 l 1 if i 1 l L 1 I l J 1900 1910 1920 1930 1940 1950 1960 i970 1980 1990 2000 2010 2020 2030 2040 2050 l J Source: Federal lnteragency Forum on Aging. Older Americans 2006(13) Projected US. Census Bureau. Dccennial Census and Projection This trend is not just unique to the US. The global population aged 65 and over was estimated to be 420 million people as of midyear 2000, which was an increase of 9.5 million from midyear 1999; this trend will continue. (See Table 1) Twenty-six nations had an elderly population of least 2 million in 1990, and by 2000, 31 countries had reached the 2-million mark. More than 60 countries are expected to have 2 million or more people aged 65 and over by 2030 and some countries’ elderly populations will double and, even triple, by 2030. (14) (See Figure 4) Table 1 - Percent elderly around the world by region and age: 2000 to 2030 . 65 years 75 years 80 years me Year and over and over and over Europe ................................. , 2600 155 6_6 3.3 2015 18.7 8.8 5 2 2030 24.3 11 8 7.1 North America ..........................' 2000 126 6,0 3_3 2015 14.9 6.4 3.9 2030 20.3 9.4 5 4 Oceania ................................. 2000 10 2 4,4 23 2015 12 4 5.2 31 2030 16.3 7.5 4.4 Asia ..................................... 2000 6 o 1 9 o 3 2015 7.8 2.8 14 2030 12.0 4.6 22 Latin America‘Caribbean --------------- 2000 5 5 1 9 0 9 2015 7 5 2.8 1 5 2030 11 5 4.6 2.4 Near Eastflxorth Attica ------------------ 2000 4 3 1.4 0 6 2015 5 3 1 9 0 9 2030 a 1 2.8 1.3 Sub-Saharan Africa ..................... 2000 2 9 0 3 0 3 2015 3 2 1.0 0 4 2030 3.7 1.3 0 6 Source: US. Census Bureau, Aging around the world: 2001 (14) US. Census Bureau, 2000a. figure 4 - Percent increase in elderly population around the world: 2000 to 2030 I: Developed countries a Developing countries Singapore Malaysia Colombia Costa Rica Philippines Indonesia Mexico South Korea 372 jamalca Cmada Kenya Australia israel United States New Zealand Luxembourg Argentina Poland Austria Denmark Czech Republic Germany Norway France United Kingdom Japan Belgium Russia Uruguay Sweden Zimbabwe Italy Greece Malawi Hungary Ukraine Bulgaria l 4 Source: US. Census Bureau, Aging around the world: 2001 (14) US. Census Bureau, 2000a. In addition to the rapidly aging population, there are a growing number of people with disabilities. Census 2000 counted 49.7 million people with some type of long lasting condition or disability in the US. (See Figure 5) They represented 19.3 percent of the 257.2 million people who were aged 5 and older in the civilian non—institutionalized population — or nearly one person in five. (15) Figure 5 - Selected chronic health conditions causing limitation of activity among adults by age: 1998 to 2000 (Number of people with limitation of activity caused by selected chronic health conditions per 1,000 population) Arthrltls, other musculoskeletal 193 I Heart other circulatory Visron/hearina - IS to 44 -45 to 64 E65 to 74 - 75 and over Fractures/1mm injury Diabetes Mental illness Note: The reference population for these data is the civilian noninstitutionalized population Source: US. Census Bureau, 65+ in the United States: 2005 (12) National Center for Health Statistics, 2002a. Figure 17 The exclusion of those with “permanent or temporary illness, injury, or disability” from the government-directed testing unfairly punishes the elderly, who are more likely to be afflicted by disability than younger consumers. (See Figure 6 and 7) This is ironic, as it is the older population that the test protocol is intended to serve. Figure 6 - Disability prevalence by age Percent with specified level of disability 80 yrs and over 57 00/ 71.7% L . 0 75-79 yrs of age _m— 539% 70 - 74 yrs of age 30 10/ 46.9% — o 0 65 - 69 yrs of age . 25 40/ 38.4% - e 0 28.1% I Severe I Any 55 - 64 yrs of age 19.3% 45 - 54 yrs of age m 619.4% 25 - 44 yrs of age Eng/3.1% 15 -24 yrs of age ”go/010.5% Source: US. Bureau of the Census Americans with Disabilities: 2002 - Table l (16) Figure 7 - Severe disability distribution by age Percent distribution of persons with severe disability by age ,I < 15 years of I 80 years and i age, 6.3% 0V”. 159% , I 15 -24 years of age, 5.9% D 25 - 44 years of age, 18.5% I 65 - 79 years of age, 23.3% D 45 - 54 years of I 55 - 64 years of age. 15.4% age, 15.6% Source: US. Bureau of the Census Americans with Disabilities: 2002 - Table l (16) ARTHRITIS Arthritis is the leading cause of disability among US. adults, affecting 16 million Americans in 2002 (See Figure 8). Each year, arthritis is responsible for 750,000 hospitalizations and 36 million out patient visits. As a result, arthritis is estimated to cost $51 billion in medical costs and an additional $35 billion for indirect costs, such as lost wages (in 1997 US. dollars) each year (See Figure 9). As the population ages, arthritis related costs are going to soar. ( l 7) figure 8 - Top 10 most common causes of disability among Americans aged 18 years or older, 1999 Arthritis or More Back at spine problem Heart MW at the arteries Lung or respiratory problem Dearest or hearing probiem Limbiextremity stillness Men“ or emotions problem Diabetes Blndness or vision problem Stroke 0 5 1O 15 20 Penning-atoll dubiiy Source: CDC, Preventing Arthritis Pain and Disability: 2006 (18) CDC Prevalence of disabilities and associated health conditions among adults - United States 1999 MMWR 2001;50: 120-5 12 Figure 9 - Annual U.S. burden Annual U.S. Burden Source. CDC, At- A- Glance: 2006(17) http//www.cdc.gov/arthritis/indexhtm What is Arthritis? The word arthritis means joint inflammation, which comprises over 100 different rheumatic diseases and conditions that affect joints, the tissues surrounding joints and other connective tissue. “Typically, rheumatic conditions are characterized by pain and stiffiiess in and around one or more joints. The symptoms can develop gradually or suddenly. Certain rheumatic conditions can also involve the immune system and various internal organs of the body.” (19) Patients with arthritis in the hands experience fluctuating levels of joint pain, lack of overall strength, weakened grip, limited pinch strength, diminished manual dexterity and the inability to squeeze and press. All of these factors have the potential to impact the ability of people afflicted with arthritis to open packages. Why is Arthritis a Public Health Problem? “In 2002, 43 million American adults (about 1 in 5) reported doctor-diagnosed arthritis.” (17) Another 23 million people reported chronic joint symptoms but had not 13 been told by a doctor that they had arthritis. These data indicate that arthritis is one of the U.S.’s most common health problems. Arthritis is more common among older adults (See Figure 10), but it can also affect other segments of population, such as children and young adults. As the population ages, these numbers are likely to increase dramatically. According to the Centers for Disease Control and Prevention (CDC), the number of pCOple who have doctor-diagnosed arthritis is projected to increase to 67million by 2030 (See Figure 11) and those aged 65 and older that have doctor-diagnosed arthritis is expected to double by 2030 as well. Figure 10 - Prevalence of doctor-diagnosed arthritis among U.S. adults by age group, 2003-2005 60.0% *--—- ._.__ __ 50.0% -- -- - ._ V- - . ,- 40.0% - WW- 30.0% - -+ _. - 20.0% - ——--—- _. W _- _ 10.0% ~- _ 0.0% E 18-44 45-64 65 or older Source: CDC, Data and Statistics (20) National Health Interview Survey Morbidity and Mortality Weekly Report 2006; 55(40); 1089-1092 l4 Figure 11 - Projected number of adults with arthritis and arthritis-attributable activity limitations, 2005-2030 100 - 90 _ I Adults With Anhnts so - Adults with Arthritis-Attributable Actrvsty Limitations 70 “- - 67 g 63 .3 60 L- 56 5° 5 52 2 50 -- 5 4o .. 30 .— 20 ... 10 '- 2010 2015 2020 2025 2030 Source: CDC, At-A-G lance: 2006(17) Year Hootman JM , Helmick CG. Projections of U.S. Prevalence of Arthritis and Associated Activity Limitations. Arthritis and Rheumatism 2006; 64(1):226-9 Types of Arthritis Some of the more common forms of arthritis are osteoarthritis, rheumatoid arthritis, gout, and fibromyalgia (See Figure 12). Research presented here involves people that self-reported a doctor’s diagnosis of either osteo or rheumatoid arthritis, the two most common forms of the disease. 15 Figure 12 — The approximate number of cases in the United States ofsome common forms ofarthritis in 1996 Source: U.S. Food and Drug Administration. Arthritis (2]) httpznwwwfdav. ’“ L' ’i""’ r 1.4. "' jpeo Ur U D Osteoarthritis Osteoarthritis (0A) is by far the most common form of arthritis (See Figure 12), and occurs most often in older people. 0A is a joint disease that mostly affects the cartilage. Cartilage is the slippery tissue that covers the ends of bones in a joint. This allows bones to glide over each other and helps to absorb the shock of movement. In 0A, the cartilage becomes worn, therefore, the bones can rub together resulting in pain, swelling, loss of motion of the joint and the eventual disfiguration of the joint. Furthermore, bone spurs, or osteophytes, may form on the edges of the joints and bits of bone or cartilage can break and float inside the joint space, which causes further discomfort and damage. 0A only affects joint firnction and does not affect skin tissue, the lungs, the eyes or the blood vessels like other forms of arthritis. (22) Although the percentage of people who have OA usually grows higher with age, it can impact all sectors of the population, though generally young people develop 0A only after a joint injury or genetic defect in joint cartilage. 0A is among the most frequent disability in the U.S., impacting more than 20 million people; 12 percent of the U.S. population (22) “By 2030, 20 percent of Americans — about 70 million peOple — will have passed their 65lh birthday and will be at risk for osteoarthritis.” (22) 4.... ‘ a :91 's -' . i5} Neck (Spine) l .2 i } Lower Back (Spine) . ,I _ ”N- 0‘ ~ “a HlpS j , J: .9“ \i‘:_ Thumbs (Hands) Fingers (Hands) ——.;_;, .J . \ Knees .______I..'._ l tin-AA Figure 13 — Areas of the body most frequently impacted by CA Source: National Institute of Arthritis and Musculoskeletal and Skin Diseases and The National Institutes of Health, 2002 (22) 0A most often occurs in the hands (at the ends of the fingers and thumbs), spine, knees, and hips (See Figure 13). For the scope of this research, discussion presented here will be limited to the impact of CA on the joints of the hands, as this is the mostly likely factor to impact a person’s ability to successfully use a package. 17 0A is hypothesized to be hereditary; those that have relatives afflicted with osteoarthritis are at greater risk for developing than those that do not. Additionally, there is an increased propensity of osteoarthritis with hand involvement for women, as compared to men and, for most, it develops afier menopause. Small, bony knobs called Heberden’s nodes may appear on the end joints of the fingers (See Figure 14). Bouchard’s nodes can also appear on the middle joints of the fingers. Fingers can become enlarged and gnarled, and they may ache or be stiff and numb. Furthermore, the base of the thumb joint is commonly affected by osteoarthritis as well. Figure 14 - Osteoarthritis 4.- Li ' - l l 1*“ T l _-_ — iii) A ._ 4 .. _ 1W4 Fusiform - ‘ swelling : — of joints 1 a m . l._, Rheumatoid Arthritis Rheumatoid arthritis (RA) is the second most common form of arthritis and it is an inflammatory disease that causes pain, swelling, stiffness, and loss of function in the joints of the body. Unlike 0A, it is an autoimmune disease which has the potential to affect other parts of the body besides the joints. A person’s immune system, which normally helps protect the body from disease and infection, begins to attack joint tissues. White blood cells, the agents from the immune system, travel to the synovium (soft tissue within the joint) and cause inflammation which is characterized by warmth, redness, swelling and pain. The reason for this is unknown. As the RA conditions worsen, the inflammation of the synovium will damage the cartilage and bones of the joint and weaken the muscles and tendons surrounding the joint, leading to osteoporosis (fragile bones that are prone to fracture). (See Figure 15) Figure 15 - Rheumatoid arthrits Wt? Ulnar deviation of ’ f Swan-neck metacarpophalangeal ‘ deformity 0f joints fingers I_ i j l 1 RA is symmetrical in its patterning, if one side of the patient’s body is impacted; it is likely that the other will be as well. In some patients, RA is characterized by “flares” and remissions; periods of time of worsening symptoms followed by periods of relief. In 19 others, the disease manifests itself in constant pain. In addition to the pain and swelling that patients can experience, many also experience fevers, fatigue and a general sense of not feeling well. Some will have joint damage as mentioned above, others will not. RA often impacts the wrist joints and the finger joints closest to the hand. Although the disease ofien begins in middle age, and has increasing frequency in older people, it can also be present in children and young adults. Like 0A, RA is more prevalent in women than in men; about 2 to 3 times as many women are impacted by the disease as men. (23) (See Figure 16) Figure 16 - Projected prevalence of doctor-diagnosed arthritis, U.S. adults aged 18+ years, 2005-2030 H) Projected rumba o! M with doctor- dammd m (In mlllonl) 3305 2C! 1 0 20 ‘- 5 2020 21325 QUE-CI Source: CDC. At-A-Glance: 2006(17) Hootman JM . Helmick CG. Projections ofU.S. Prevalence of Arthritis and Associated Activity Limitations. Arthritis and Rheumatism 2006; 64(1):226-9 20 PACKAGING AND PEOPLE WITH ARTHRITIS A limited number of publications concentrate on the performance of child resistant packaging in the hands of people with arthritis. In 1976, researchers from the Centre for Rheumatic Diseases in Glasgow, Scotland gave 10 “standard” tablet containers to 200 outpatients with rheumatoid arthritis (RA). (24) Forty-six males and 154 females ranging in age from 15-77 were tested for their ability to open each container within a two minute time frame. The order of container presentation was the same for all subjects, and the containers were not characterized in the published research by size, type or child resistance, but listed only as “1-10.” Results were recorded as the percentage of patients able to open each container, and the mean time to open (in minutes) by package number. Results indicated that patients had “considerable difficulty” opening at least five of the ten bottles. The five that remained had “screw tops” (non-CR), and were found to be much more easily opened. A study conducted at the University of Manchester (UK) during the 19805 examined the ability of 50 patients with RA with hand involvement to open several drug packages. This data was compared to the results from 50 “normal” control patients. (25) Eight designs were tested in multiple sizes, so that a total 19 package types were used for the study. “Only eight patients and 41 controls were able to open all the containers, but all 50 controls and 48 patients managed to open all the screw capped [Continuous Thread closure/ non-CR] tablet bottles tested... Only 10 patients and 41 controls were able to open the small size clic-loc [Push and Turn] container.” (25) Researchers concluded that 21 re-closable child resistant closures (CRs) presented “considerable difficulties” for patients with RA. In 1984, research was conducted to examine the ease of use of twelve containers (10 were currently used in the market at that time) used to dispense anti-inflammatory drugs to 99 patients with arthritis with hand involvement. The containers were given in random order and subjects were asked to open them. The opening and closing time were recorded. Also, to quantify the degree of impairment of the arthritic hands, grip strength was recorded for each patient. Finally, patients were asked to comment on each package in terms of the size, shape and design of the closures and bottles as good or bad and rate the containers accordingly. The research did not describe each type of container in detail, but indicated “screw top” containers (non-CR) to be the preferred choice, adding “childproof’ is also “arthritis proof.” (26) 22 CHILD RESISTANT CONTAINERS IN THE HANDS OF PEOPLE WITHOUT ARTHRITIS Other studies that did not purposefully collect data from people with arthritis suggest that older adults have difficulties with these packages, even if they have not had a positive arthritis diagnosis. In 1971 research was conducted to compare “Palm-‘N’-Tum” (Push down and turn) safety vials and “pop top” vials (non-CR). (27) Patients were divided into two groups (safety vs. control), and the vials (CR and non-CR) were dispensed to patients according to their groups; “pop top” vials were provided to subjects in the control group and “Palm-‘N’-Turn” vials were provided to those in the safety group. Seventy-one safety and 63 control group interviews were completed with subjects, who ranged in age from 22-87. Results showed that the patients in the safety group reported significantly more difficulty opening and closing their vials than did control patients. Only 27 percent of the safety patients reported no difficulty mastering the “Palm-N-Tum” vials. Sixteen percent of the safety containers were improperly closed compared to 2 percent of the “pop top” containers. Some of these patients were unaware that their containers were not properly closed and others had intentionally left their vials unlocked. Furthermore, a total of 14 patients from both groups had transferred their pills into other vials for reasons that included faster opening, difficulty opening safety vial, etc. In 1977, McIntire et al. found one-third of patients over the age of 60 years residing in the senior community were unable to reliably remove their tablets from CR containers. Of those, 9% discontinued use of the medications, while the remaining 91% 23 left the top off the container, changed containers, or made some kind of modification to improve access to medication. (28) A survey carried out by Myers in 1977 examined the experience of 100 outpatients with a CR container; in order to open this container “required that the middle of three tabs on the closures be rotated to align it with an indentation in a flange around the top of the container. Then a point of leverage was provided for upward pressure against the bottom of the exposed tab, making it possible to remove the closure.” (29) The average patient age was 41.2 years. Results indicated that only 60 (out of 100) patients could open the tested containers. All containers that were tested were new. Eighty-three patients experienced difficulty with the container, and as a result, 43 patients reported accidental spillage of their drugs. Furthermore, 46 patients used tools: knives, can openers, screwdrivers or similar in order to open the container. Thirty-eight patients handled the container in ways in which the CR effectiveness was reduced; closures were left off of the containers between doses, for example. In 1979, Sherman et a1. reviewed the opening and closing of CR containers by 120 community—residing elderly persons. Their results indicated that 60% acknowledged having difficulty opening or closing CR medication containers; 64% of all women tested (average age, 70 years) and 36% of all men tested (average age, 67 years). Because of the difficulty with the CR features, 33% of the community—residing, elderly patients (older than 60 years) admitted to improperly using CR packaging, by either changing to a non-CR, leaving the top off, combining medication, or making some other modification that improved accessibility. Additionally, 9% out of the 33% who had difficulty with the CR containers had discontinued use of the medication. (30) 24 In 1980, researchers from The Children’s Orthopedic Hospital and Medical Center carried out a survey regarding “safety caps” and senior citizens. (31) Completed questionnaires were obtained from 330 senior citizens. Five questions focused on the senior citizen’s experiences with safety caps (child-resistant). The survey results showed that while nearly all senior citizens had had experience with CR containers, many found them to present problems. More than half of the respondents stated that they had either transferred their medications to other containers, or simply left the CR containers open, rendering them non-CR. Finally, the survey showed that 37% of senior citizens were unaware that they could request a non—CR container from the pharmacists. Another study indicates that “tamper-resistant” packaging, like CR packaging, may prevent the elderly and other adults who have mental, motor, and/or sensory disabilities from accessing their medications. “Tamper—resistant” requirements for all over-the-counter (OTC) drugs and certain cosmetics began in February 1983. (32) Observations of older people (especially those over 75 years of age) navigating “tamper resistant” packaging were conducted by Sherman in 1985. The author found out that elderly subjects either failed to gain access, used tools, struggled for such a lengthy time that frustration or anxiety caused them to give up, or they used their mouths. The author concluded that “unless the existing ‘tarnper-resistant’ packaging is modified, it is likely that 26 million older people in this country may find ‘tamper-resistant’ packaging ‘elder- resistant’ as well.” (32) Keram et al. (1988) quantified the ability of older persons in opening various medication containers. Fifty noninstitutionalized women and men over 60 years of age were timed while opening 15 containers with and without CR functions. Participants 25 . it.) i it} ill II' Illlr III, ill! ll... . .. a (IllblIll. ‘Ili Ill 1i [Iii I'll: 1‘ ill ii were also asked to rate the containers, as expressed on an ll-point visual analog scale. All subjects could open each of the non-CR containers, although none of the CR containers were opened by all participants. Over 30% of participants could not open some CR designs. Also, “among the CR designs four containers had average opening times of over 20 seconds, more than triple the 6.1 seconds recorded for the most easily opened child-resistant container, a large push and turn pill bottle. The shortest mean opening time among the child-resistant containers (6.1 seconds) was approximately 25% longer than the shortest mean opening time among the containers which were not child- resistant (4.6 seconds)” (33) In 1989, Meyer et al. looked at the ability of 93 geriatric patients (89 men and 4 women with an average age of 74.3) to perform multiple medication taking skills; read the label, open and close “safety caps” (CR) and “flip caps” (Non-CR), remove tablets interpret directions, and recognize color. One of the sections that compared the ability of elderly people to open and close CR and non-CR vials indicates little difference in ability to open and close the two types. However the data still showed nearly 12% of the patients were unable to open/close “safety cap” (CR design) properly. (34) A study by Fleming et a1. (1993) of 100 elderly patients admitted to home health agencies in North Carolina indicated that 40% experienced difficulties opening their medication bottles. Most medications (77%) were stored in CR containers. The authors also found 50% of the patients were unable to read their prescription bottle labels. (35, 36) Atkin et al. (1994) evaluated the difficulties experienced by elderly people in opening and removing tablets from a range of commercial medication containers and in the breaking of a scored tablet. Of 120 patients admitted to an acute geriatric service, 94 26 (78.3%) were unable to open a container or break a scored tablet. Excluding those patients whose only failure was an inability to break a tablet, 76 (63%) were unable to open 1 or more of the tested containers. Patients with manipulative problems did develop other strategies to help them to deal with these difficulties such as: leaving the top off the bottles, placing tablets in alternative containers, and using a knife to break tablets. (37) A series of Government Consumer Safety Research studies on aging related issues on packaging were conducted by the British Department of Trade and Industry in London from the late 19905 until early 2000. (10) In one of the studies, the researchers assessed broad, age-related issues for package opening. In the case study, participants ranged in age from 55 to 82, and most of them had some kind of health issues such as arthritis, back problems, partial loss of finger sensation, poor eyesight, or tremors. Sixty- three of the 103 participants had arthritis involving their wrists, fingers or elbows. Each participant was allowed 6 minutes to carry out several tasks, which included opening a glass bottle with both a tamper evident and a CR features and reclosing the bottle top securely. Eighty percent of the subjects were able to open the closure without any instruction, and completed the tasks in under 3 minutes. Eighteen percent of subjects needed verbal instruction, even after studying the graphics, to complete the tasks within 6 minutes. One percent of the subjects needed a demonstration before successfully opening the closure and another 1% failed to open the glass bottle after demonstration. (10) In 2002, Rahman et al. looked at the relationship between hand strength and the forces used to access common household containers by well elderly persons. The study included forty-two women and 9 men over the age of 60 and randomly assigned them into one of four groups to counterbalance the research. A grip dynamometer was used to 27 measure grip strength and pinch strength was measured using a pinch meter. Furthermore, force sensing resistors were applied to each of the 6 common household containers to measure the forces required to access them. “Analyses of variance were used to determine difference by gender on the dependent measures and order of presentation of containers.” (8) The results showed a fair relationship was found between grip and pinch strength and the ability to open three containers but little or no relationship was found in the remaining of three containers. As a result, “strong relationships did not exist between the grip and pinch strength and the amount of force the elderly used to open the containers” and “significant gender differences existed on overall strength and the force used to access two of the six containers.” (8) A. Donaghy (2003), from the Pharmacy Department of Calderdale NHS Hospitals Trust, and D. Wring, from the University of Bradford School of Pharmacy, studied patients over the age of 60 to examine their ability to open child resistant closures. Only 43 percent of the 207 patients were able to open the tested child-resistant closures. The research also concluded that once a patient reached the age of 80, the ability to Open the containers and read labels was greatly reduced. Further, the researchers recommended that patients should be assessed for their ability to open containers and read labels prior to hospital discharge. (9) 28 CHILD POISONING AND GRANDPARENT CAREGIVERS The introduction of CR packaging, as required by the PPPA in 1970, caused a dramatic reduction in the number of deaths of young children; however, the number of hospital admissions, and calls to Poison Control Centers remains high and indicates that the problem is more wide spread than people think. (38) The aforementioned studies indicate that the elderly experience difficulties opening CR containers, and, as a result, they reduce the CR effectiveness by leaving the closures off of the containers between doses, transferring container contents into containers that are easy to open (Non-CR), defeating CR features, etc. These kinds of practices not only have the potential to reduce the medicine’s effectiveness; they can also result in the unintended ingestion of the contents held within by a child. In 1987, the CPSC established that grandparents’ medications were responsible for 17% of all accidental poisonings of young children. (2) Another study conducted in 1991 showed that up to 36% of prescription medication ingestions by U.S. children under five take place in grandparents’ homes, and as many as 23 % of these exposures occur when the child is visiting the grandparent. (39) Similar findings were reported in studies published in Canada in 1997 that indicated that up to 17% of all poisonings involving children less than 6 years old occurred away from their homes, with the most common site being grandparents’ homes. (1) Other reports do not specify where child poisonings occur, but state that child poisonings are still a problematic issue. One such study showed that in the US in 1998, there were 1.08 million reported instances of ingestion of toxic substances by children less than 6 years of age. (38) Similar data, reported in 2003, indicates that nearly 2.25 29 million calls were placed to the 65 Poison Control Centers in the United States, and half of these calls were an incident involving a child under 6 years of age. (40) Furthermore, there are similar patterns around the world. In Victoria, Australia, with approximately 300,000 children less than 5 years of age, an average of 658 children are admitted to hospitals each year because of ingestion of hazardous substances, mostly pharmaceuticals. (3 8) A report from the UK, published in 2004, states that the alarming consequence of adults often transferring pills into non-safe containers, is thought to contribute to approximately 10,000 cases of accidental poisoning each year in the UK; eighty percent of which involve children under four. (41) The trend of increased grandparent caregivers has the potential to exacerbate this issue further. Census 2000 Brief (Grandparents Living with Grandchildren) indicates that 5.8 million grandparents live with grandchildren younger than 18 (2.3 million were aged 60 and over). Among the 5.8 million grandparents living with grandchildren, 2.4 million grandparents were also considered as “grandparent caregivers”, grandparents which had primary responsibility for their grandchildren younger than 18 (See Figure 17). Among these grandparent caregivers, 39 percent had cared for their grandchildren for 5 or more years. Furthermore, more than 700,000 of these caregivers over 60 and were responsible for their grandchild for 5 years or more. (42) (See Figure 18) Any improper use of CR containers by grandparents (including defeating the CR-effectiveness, leaving the lid off, transferring contents into non-CR containers, etc.) has the potential to result in an unintended poisoning of the child in the grandparents home. 30 Figure 17 - Percent of grandparent caregivers by age ' I 80 yrs and over I 1.0% 70 to 79 yrs of age I 7.1% 60 to 69 yrs of age I 20.9% 40 to 49 yrs of age . 29.2% 6.7% l 50 to 59 yrs of age I 35.1% ! ! l l 30 to 39 yrs ofage I Source: Census 2000 BriefGrandparents Living With Grandchildren: 2000 (42) F i are 18 - Percent rand arent care ivers distribution b duration 8 g P g y of time responsible 1 00/0 Source: Census 2000 Brief Grandparents Living With Grandchildren: 2000 (42) 0 5.0% 17.1 /o 40.3% 29 50/ l 50/ . o o . o 32.8% 10'7 /° 10.5% 36.0% 37.80/ 5 yrs or more ° 194% 6.0% 0.9% 3 to 4 yrs 11.90/0 l to 2 yrs 31.6% 6 to 11 months 3730/0 1500/0 4.50/0 0.60/0 I Less than 6 months 30.7”/ I o 14.8% 4.6% 045% 14.8‘70 - -- F I . 39.4% . ~* ”- '- . ' 273% 12.9% 4.3% 07% j 1 t. . ‘1 1: , i. r g L .1 . 30 to 39 yrs 40 to 49 yrs 50 to 59 yrs 60 to 69 yrs 70 to 79 yrs 80 yrs and of age of age of age of age of age over This trend in grandparent caregivers, the graying of the population, the increasing prevalence of people with disabilities and a review of the literature, which indicates that 31 older consumers frequently have difficulty with CR packaging make research into the issue of CR packaging in the hands of arthritics warranted. 32 NULL HYPOTHESES Ten packages were tested by all subjects. Three designs (Continuous Thread (non-CR), Push and Turn, and Squeeze Loks), in varying diameters and shapes (see Figure 20) were tested. Researchers tested the following null hypotheses: There is no effect of subject (arthritic vs. control) on the number of openings or the time to open or close packages; cases and controls will be able to access and close types/designs with equal ease. There is no effect of gender (male vs. female) on the number of openings or the time to open or close packages. There is no effect of CR on the number of openings on the time to open or close; child resistant designs will be opened and closed as frequently and quickly as non-child resistant designs. There is no effect of type/design on the number of Openings or the time to open or close; each of the ten types/three designs will be opened with the same frequency and require equal amounts of time to open. There is no effect of size on the number of openings or the time to open or close. To analyze this hypothesis packages will be grouped into three sizes (small, medium and large) due to the fact that inconsistent diameters were received. (See Figure 19) 33 Figure 19 - The containers tested by size, shape, and design 4,. .‘ Irma h 2 Red indicates non-CR Q I. J LmI . '4 closuresf: L___i 0 Blue indicates push and ._ ......I ‘ turn closuresi] Green indicates squeeze Lok closures. “small” “medium” “large” White numbers represent bottle neck finishes 34 METHODOLOGY The ability of 50 subjects, aged 60 or older, who indicated a doctor’s diagnosis of 0A or RA with hand involvement, and 50 matched control subjects, to open a variety of types and sizes of child resistant (CR) packages was tested. Control subjects did not have a diagnosis from a doctor, and were matched for age and gender with the diagnosed subjects. Three package designs (in different finish sizes) were tested. (See Figures 19 and 20) They were: 0 Two-piece push and turn closures (Rexam- Evansville, IN bottle finish sizes — 20mm, 24mm, 28mm, 45mm), 0 Squeeze Lok closures (Rexam- Evansville, IN bottle finish sizes — 24mm, 38mm), and 0 Continuous Thread closures — non-C R (Rexam- Evansville, IN bottle finish sizes — 20mm, 24mm, 28mm, 45mm) 0 Bottles (in appropriate finishes- Alcan Packaging Plastics America Dallas, TX) 35 Figure 20 - The containers tested These finish diameters were chosen so that they included two commonly used sizes (24 mm and 28 mm) and extreme sizes (20 mm and 45mm). Efforts were made to keep the liner type, bottle and cap material, cap diameter and thread contact area as constant as possible across all bottle designs. Designs and sizes were rotated to balance any potential effect of subject fatigue. The first bottle of each type was filled with Hot Tamales candies to its neck. The number of Hot Tamales candies required was counted and used for remaining bottles of this type. The packages were secured 72 hours before testing at 10 in-pounds of torque using an electronic torque tester by Secure Pak, Inc. (7) All packages were new prior to testing and were only used one time. All researchers were trained at their respective institutions with regard to the appropriate treatment of human subjects. Michigan State University, which served as the lead institution on this project cleared the project protocol through its IRB (UCRIHS) (IRB# 05-819 / APP# i023406) (See Appendix A) first. Prior to testing, training and an 36 inter-rater reliability study was led by researchers at Western Michigan University, to ensure consistency between the readings interpreted by the Occupational Therapy student. Testing sessions lasted no longer than 1 hour, and began with informed consent (See Appendices B and C). Subjects with arthritis were recruited from a variety of locations across the state of Michigan (See Appendix D), including senior centers, senior apartments and rheumatology clinics. Only people that were 60 or older, and still preparing their own meals and living independently were eligible to participate. Each subject was assigned a subject number. Their: age, gender, principle diagnosis, duration of disease, self-reported hand dominance, duration of disease impacting hand use, education level and eyewear needs were recorded under this number. Table 2 includes a synopsis of the data that was collected throughout testing (See Appendix E). Table 2 - Data collection (Occflational Therapy (OT); Packaging PKG)) . Approximate . Step R:sponsrble Activity to be performed duration of ;:taslet(rime p “y activity p 1 OT/PKG Obtain informed, written consent 7 minutes 7 minutes 2 OT/PKG Subject information 1 minute 8 minutes 3. OT Assessment of pain 0.5 minutes 8.5 minutes Mini Mental State Examination . . 4 OT (MMSE) testing 8 minutes 16.5 nnnutes 5 OT girtal photograph documenting hand 05 minutes 17 minutes 6. OT Grip Dynamometer 4 minutes 21 minutes 7. OT Visual Acuity 1 minutes 22 minutes 8 OT Wrist Dynamometer 1 minute 23 minutes 9 OT Bulb dynamometer 1 minute 24 minutes 10. OT Assessment of pain 0.5 minutes 24.5 minutes 1 l Refreshment Break / Survey information 10 minutes 34.5 minutes Testing of a group of 5 packages . . 12. PKG (GROUP 1) 10 minutes 44.5m1nutes 13. PKG Rest period at table 3 minutes 47.5 minutes 14. PKG Measurement 0f fimc‘mm‘ gr 1" 2 minutes , 49.5 minutes diameter 15. PKG Assessment of Pain 0.5 minutes 50 minutes Testing of a group of 5 packages . . l6. PKG (GROUP 2) 10 minutes 60 mrnutes 37 If a subject indicated that they used corrective eyewear for reading, they were asked to use their eyewear during the course of testing. Researchers also recorded the subject’s current level of pain using a scale of 1-10, where 10 represented the worst possible pain that can be imagined. (43) Because the study concerned the physical ability of subjects to remove a variety of types and sizes of closures, a Mini Mental State Examination (MMSE) cognitive screening test (44) was administered prior to testing, and subjects with a score of less than 21 were excused from further testing without penalty. To characterize the size of each subject’s hands, researchers asked each subject to lay their hands flat on a grid system of known proportions, and a digital picture of each hand was recorded. Pictures were saved with the subject number followed by an “L” for left and an “R” for right. (See Figure 21) Figure 21 - Digital photography (with grid system) $3.75: mind" - V” - ”'79.". ' . i a , b Source: Reprinted with permission of Javier de la Fuente, from "The use of a universal design methodology for developing child-resistant drug packaging" (l 1) To quantify the degree of impairment of the hand, researchers from the Western and Eastern Michigan University Departments of Occupational Therapy collected data 38 regarding grip strength, wrist strength and bilateral palm to palm squeeze strength using a Jamar® grip dynamometer (See Figure 22), a Baseline® wrist dynamometer (See Figure 23) and a Baseline® pneumatic squeeze dynamometer (See Figure 24), respectively. Figure 22 - Jamar® grip dynamometer 39 Figure 24 - Baseline® pneumatic squeeze dynamometer The testing followed the standard testing position approved by the American Society of Hand Therapists (ASHT). For the grip strength testing, the individual sat in a straight-backed chair with both feet on the floor and the shoulder adducted and neutrally rotated. The elbow was flexed at 90°, the forearm was in a neutral position, and the wrist was between 0—30° extension and between 0-15° ulnar deviation. The arm was held in space rather than supported on an armrest or by the examiner. When assessing grip strength, the grip dynamometer was in the vertical position and in line with the forearm to maintain the position described above. The position of the dynamometer was located in the 2nd testing position. Everyone started the testing with the right hand, regardless of hand dominance. The individual held the squeeze maximally for 3 counts. The therapist counted these 3 seconds by verbalizing, “Squeeze as hard as you can. . .harder, harder, stop.” While the right hand was allowed time to rest, the individual repeated the grip test 40 with the left hand. This alternating sequence was be completed 2 additional times to make 3 trials on each side. Each subject’s visual acuity was measured using a Dow Corning Ophthalmic near point visual acuity card. (See Figure 25) This not only provided researchers with information about the subject’s visual acuity and helped to ascertain functional reading literacy, but also allowed their hands a rest period before further testing (See Table 2). The measurements were obtained in accordance with the manufacturers instructions. Subj ects were instructed to wear any corrective eyewear that they would normally wear for reading. They were then asked to hold the card visual acuity card 16 inches from their eyes (researchers would guide subjects to this distance using a flexible tape measure) and read the lowest line on the card that they were able. Figure 25 - Dow coming ophthalmic Again for the wrist strength testing, the individual started with the right hand. To begin, the individual held the wrist dynamometer in their left hand and gripped the knob on the dynamometer with their right. The individual was asked to turn the knob counter- 41 clockwise to the greatest extent of their ability. This dynamometer reading then was recorded, and the device was zeroed. The subject was then asked to pick up the wrist dynamometer with their right hand and grip the knob with their left. They were again instructed to turn the knob counter-clockwise. This continued until a total of three trials on each side had been collected. Lastly, the palmer strength testing was completed. The individual was positioned by following the ASHT testing position as described for grip. The individual was instructed to place each of their hands on opposite sides of the bulb with their fingers positioned 90° apart. The individual held the squeeze maximally for 3 counts and the therapist counted these 3 seconds by verbalizing, “hold, hold, hold.” Each subject was allowed to place the bulb dynamometer on either the left or the right hand and squeeze with the other hand. Researchers would ask the subjects to be consistent regarding the’ way they squeezed. Three trials were recorded for each subject. This was followed by a reassessment of pain using the 10 point scale. (43) Assessments of pain, using the pain scale described previously, were conducted at regular intervals (See Table 2). If a subject’s self-assessment of hand and wrist pain increased by more than 2 points on the pain scale, or exceeded 7 at any point during the testing, they were excused from testing without penalty. During a brief rest period, OT researchers questioned subjects about their performance, the importance of, and satisfaction with managing their medication. Responses were recorded on a scale of 1-10, where 10 was the most positive response. Subjects also filled out a brief survey that included: 0 the number of medications that they require daily 42 0 whether or not they open their own medications o awareness that they can request medication in a non-CR format fi'om their pharmacist o awareness that they can buy over-the-counter medications in a non-CR format After a break, researchers from the MSU team began the package testing portion of the protocol. A11 package testing was recorded using a Sony TRV133 digital video camera. Video clips were then used to verify recorded opening and closing times. 2-1 ,28inm P&T 2-2 38mmSL 23 gamer 24' '24mmP&T 26 Figure 26 - Statistical coding and package ID # Two groups of five packages were tested with activities or rest between each group (See Table 2); the package ID#s contained within each group changed for each subject, as the treatments were rotated to balance any effect of fatigue. Treatments (design and size) were assigned a number and each package, a specific combination of treatments, was assigned a package ID (see Table 3 and Figure 26). Package designs and sizes were rotated so that the effect of fatigue (if any) was balanced across treatments; the first subject viewed packages 1 through 10, subject two began with 2 through 10 and 43 ended with 1, etc. Dimensions (closure outside diameter, closure skirt length, bottle height to the neck, and bottle width) of the packages were measured by using an optical comparator (profile projector) made by Bridgeport Machine, Inc. (See Table 4 and Appendix F) Table 3 - Statistical codinwd package ID # 362:1? # - Package Description :ackage ID 1-1 Continuous Thread, non-CR (CT), 20 mm {finish size} 1 1-2 Push and Turn (P&T), 45 mm {finish size} 2 1-3 Squeeze Lok (SL), 24 mm {finish size} 3 1-4 Continuous Thread, non-CR (CT), 24 mm {finish size} 4 1-5 Push and Turn (P&T), 20mm {finish size} 5 2-1 Continuous Thread, non-CR (CT), 45 mm {finish size} 6 2-2 Push and Turn (P&T), 28 mm {finish size} 7 2-3 Squeeze Lok (SL), 38 mm {finish size} 8 2-4 Continuous Thread, non-CR (CT), 28 mm {finish size} 9 2-5 Push and Turn (P&T), 24 mm {finish size} 10 Table 4 - Package dimension in mm 20mm 20mm 24mm 24mm 24mm 28mm 28mm 38mm 45mm 45mm CT P&T CT P&T SL CT P&T SL CT P&T COD 23.11 27.18 27.43 30.81 32.44 30.75 34.15 46.38 46.95 51.49 CSL 12.01 17.91 11.68 17.37 15.52 11.76 17.73 16.55 10.99 18.10 BH“ 65.57 65,57 62.65 62.65 45.87 40.20 40.20 73.12 66.87 66.87 BW/D 38.43 38.43 40.74 40.74 33.24 35.71 35.71 46.55 57.18 57.18 ~COD: Closure Outside Diameter -CSL: Closure Skirt Length -BH*: Bottle Height (to the Neck) -BW/D: Bottle Width/Diameter To test the packages, a package was placed on a table within easy reach of the subject. Subjects were then asked, “Can you try to open this package for me”? Timing commenced from the moment that the subject picked up the package, and ended when it was successfully opened, or 70 seconds elapsed, whichever occurred first. Seventy seconds was chosen based on a study conducted by Keram and Williams (33) that was published in the Journal of the American Geriatrics Society. By repeating 44 this interval, interesting parallels may be drawn between results from their study, which was conducted on U.S. CR packaging prior to the 1995 change in the senior friendly portion of the CPSC protocol, and present day CR packages. In the event that a subject successfully opened the package, they were given an additional 70 second period and asked to re-close it. The time to re-close the package was also recorded. Subjects were allowed to stop and move on to the next package at any time they wished; in the event that a subject continued trying unsuccessfully for 70 seconds, the researcher recorded the package as a failure and began testing a new package. Between the test groups of five packages each, researchers determined the subject’s “functional grip diameter.” The functional grip diameter was determined by asking the subject to slide their hand as far down a cone shaped measuring device (See Figure 27) as they were able while still maintaining tip-to-tip contact with their lSt and 2nd digits. They were then asked to repeat this using their 1St and 3rd digits. Both the left and right hand were measured. Figure 27 - Functional grip diameter measuring cone Source: Reprinted with permission of Javier de la Fuente. from "The use ofa universal desrgr methodology for developing childqesrstant drug packaging" (1 1) 45 RESULTS AND DISCUSSION Subject Information Researchers collected data from 110 subjects (See Appendix G). The research team was unable to find a controlled match for 8 of the subjects (5 females and 3 males), so these were not included in the data analysis. One subject was excluded from test because his pain scale exceeded a “7” and a second was excluded because her MMSE score was lower than 21; matched controls were not sought for these individuals. As a result, 100 subjects were included in the data analysis; of these 90 were females and 10 were males. Fifty of the subjects were patients with a self-indicated doctor’s diagnosis of arthritis with hand involvement, of these 45 were women and 5 were men, and 50 were controls matched for age and gender. (Age was considered a match if the subject was within +/- 1 year). See Table 5 for a complete breakdown of the subject type. Table 5 - Breakdown of subjects included in the analysis Female Male Total # 90 10 # of Subjects with Doctor’s Diagnosis of Rheumatoid 11 2 Arthritis (RA) # of Subjects with Doctor’s Diagnosis of Osteo Arthritis 23 1 (0A) # of Subjects with a Doctor’s Diagnosis of Both 6 _ Rheumatoid Arthritis and Osteo Arthritis (OA and RA) # of Patients told by a Doctor that they have “Arthritis” 5 2 but Diagnosis not Specified # of Subgzts without a Doctor’s Diagnosis of Arthritis 45 5 The average subject age was 76.5 and subjects ranged in age from 60 to 94 years (average age for male participants was 73 and 76.8 for the female participants). The mean duration of the arthritis diagnosis was 18.6 years and the mean duration of arthritis in the hand was 13.6 years. All of the participants had the use of at least one of their 46 hands. Overall, participants took an average of 7.8 medications daily, and in both genders arthritis patients took more medications daily than the controls (See Table 6). In addition, 88% of the participants opened their own medications (See Table 7). Seventy- seven percent of the participants had an education level of higher than 12th grade. Overall, the participants scored an average of 28.1 on the MMSE. Table 6 — Breakdown of medications needed daily by subject Category of Population and Average number of medications [number of people] needed daily Overall [100] 7.8 Men [10] 6.5 Women [90] 8 Men with Arthritis [5] 9 Men w/o Arthritis [5] 4 Women with Arthritisi45] 9.6 Women w/o Arthritis [45] 6.6 Table 7 - Number of people within a category that opened own medications (% of a given population opened own medications) Category ofPopulatron and Opened their own medications [number of people] Overall [100] 88 (88%) Men [10] 10 (100%) Women [90] 78 (86.7%) Men with Arthritis [5] 5 (100%) Men w/o Arthritis [5] 5 (100%) Women with Arthritis E5] 37 (82.2%) Women w/o Arthritis [45] 41 (91.1%) Analysis of Strength Information To quantify the degree of impairment of the hand, researchers also collected data regarding grip strength, wrist strength and bilateral palm to palm squeeze strength. Average results are presented in Table 8. 47 Table 8 - Avera e strepgth of the hand Category ofpopulation Grip Strength WristaStSength BilatergsSfueeze and [number °f peoPle] Right Lefi Right Left Rig/Left Overall [100] 38.9 37.4 59.5 60.4 3.7 Men [10] 58.3 58.9 92.7 110.8 7.4 Women [90] 36.7 . 34.8 55.7 54.8 3.3 Men with Arthritis [5] 42.9 46.8 104.4 111.7 6.3 Men w/o Arthritis [5L 64.9 66.3 87.6 110.5 7.9 Women with Arthritis [45L 31.0 29.2 55.5 54.4 3.0 Women w/o Arthritis [45] 41.3 39.3 55.9 55.2 3.6 Analysis of Grip Strength To analyze the strength data, i.e. to determine if men were stronger than women, etc., a 2—way ANOVA was employed (see Table 9). The 2-way ANOVA treated right grip strength as the response variable (dependent variable) and the following factors as fixed effects: 0 Diagnosis (arthritis vs. control) 0 Gender (male vs. female) 0 Diagnosis x Gender Right Effects are considered Fixed Effects Table 9 - Results of 2-way ANOVA: Resultant variable is Right Grip Strength-All Effect Num DF Den DF F Value Pr>F Diagnosis 1 986 203.45 <0.0001 Gender 1 986 218.87 <0.0001 D'ag“°s's x 1 986 39.52 <0.0001 Gender Bolded Effects were indicated to be significant at a level of 0.01. 48 The analysis was further refined so that pair-wise comparisons could be made (See Table 10). Table 10 - Analysis of varyirfieffects on Right Gri Strength Effect Gender DIAG Gender DIAG Estimate Stgndard DF t Pr> Itl rror Value Gender Female Male -21.5493 1.4566 986 -l4.79 <0.0001 DIAG 0 1 20.7766 1.4566 986 14.26 <0.0001 Gender 1: Female 0 Male 0 -30.7061 2.0611 986 -14.90 <0.0001 DIAG Gender x Female 0 Female 1 11.6199 0.9259 986 -12.55 <0.0001 DIAG 31513.2 Female 0 Male 1 -0.7727 2.0611 986 -037 0.7078 Gender x Male 0 Female 1 42.3259 2.0588 986 20.56 <0.0001 DIAG Gender 11 Male 0 Male 1 29.9333 29.9333 986 10.84 <0.0001 DIAG Gender 11 Female 1 Male 1 -12.3926 -12.3926 986 -6.02 <0.0001 DIAG DIAG = Diagnosis 0 = without arthritis, 1 = with arthritis Left The analysis was repeated for left grip strength with the results reported in Table 11. Table 11 - Results of 2-way ANOVA: Resultant variable is Left Grip Strength-All Effects are considered Fixed Effects Effect Num DF Den DF F Value Pr>F Diagnosis 1 996 171.56 <0.0001 Gender 1 996 354.66 <0.0001 magms's x 1 996 14.34 0.0002 Gender As with the results for right grip strength, the analysis was further refined so that pair-wise comparisons could be made using the left grip strength as the response variable; results from this analysis are presented in Table 12. 49 Table 12 - Analysis of varyin effects on Left Gri Strength Effect Gender DIAG Gender DIAG Estimate Standard DF t Pr > M Error Value Gender Female Male -25.6185 1.3779 996 -18.59 <0.0001 DIAG 0 1 18.0481 13779 996 13.10 <0.0001 Gender Female 0 Male 0 -30.8375 1.9487 996 -1582 <0.0001 x DIAG Gender Female 0 Female 1 12.8296 0.8715 996 -14.72 <0.0001 x DIAG Gender Female 0 Male 1 -7.s704 1.9487 996 -3.88 0.0001 x DIAG Gender Male 0 Female 1 43.6667 1.9487 996 22.41 <0.0001 x DIAG Gender Male 0 Male 1 23.2667 2.6144 996 8.90 <0.0001 x DIAG Gender Female 1 Male 1 40.4000 1.9487 996 -10.47 <0.0001 x DIAG DIAG = Diagnosis 0 = without arthritis, 1 = with arthritis Analysis of Wrist Strength Right The analysis was repeated for the right wrist strength (See Table 13). All Effects are considered Fixed Effects Table 13 - Results of 2-way ANOVA: Resultant variable is Right Wrist Strength- Effect Num DF Den DF F Value Pr>F Diagnosis 1 986 4.04 0.0448 Gender 1 986 105.58 <0.0001 Diagnosis x Gen der* 1 986 0.27 0.6015 *Diagnosis x Gender is insignificant, therefore the further statistical analysis does not cross compare the varying effect of Diagnosis x Gender in Table 14. Table 14 - Analysis of varyin effects on Right Wrist Strength Standard 1 Effect Gender DIAG Gender DIAG Estimate DF Pr > M Error Value Gender Female Male -36.8666 3.5879 986 -10.28 <0.0001 DIAG 0 1 7.2075 3.5879 986 2.01 0.0488 50 Left See Table 15 for the effect of gender and diagnosis on the strength of the left wrist. Table 15 - Results of 2-way ANOVA: Resultant variable is Left Wrist Strength- AlI Effects are considered Fixed Effects Effect Num DF Den DF F Value Pr>F Diagnosis 1 996 2.75 0.0974 Gender 1 996 261.89 <0.0001 D'ag“°s's " 1 996 24.88 <0.0001 Gender As before, the wrist analysis was further refined so that pair-wise comparisons could be made using the left wrist strength as the response variable; results of this analysis are presented in Table 16. Table 16 - Analysis of varying effects on Left Wrist Strength Standard 1 Effect Gender DIAG Gender DIAG Estimate DF Pr > M Error Value Gender Female Male -56.000 3.4604 996 -16.18 <0.0001 DIAG 0 1 -5.7407 3.4604 996 -1.66 0.0974 Gender Female 0 Male 0 -38.7407 4.8937 996 -7.92 <0.0001 x DIAG Gender Female 0 Female 1 11.5185 2.1886 996 5.26 <0.0001 x DIAG Gender Female 0 Male 1 -61.7407 4.8937 996 -12.62 <0.0001 x DIAG Gem" Male 0 Female 1 50.2593 4.8937 996 10.27 <0.0001 x DIAG Gem" Male 0 Male 1 -23.0000 6.5657 996 -3.50 0.0005 x DIAG Gender Female 1 Male 1 43.2593 4.8937 996 -14.97 <0.0001 x DIAG 51 Analysis of Bilateral Squeeze The analyses were repeated for palm to bilateral squeeze (See Table 17). Table 17 - Results of 2-way ANOVA: Resultant variable is Bilateral Squeeze-All Effects are considered Fixed Effects Effect Num DF Den DF F Value Pr>F Diagnosis 1 986 . 14.79 0.0001 Gender 1 986 330.81 <0.0001 Diagnosis x Gen der* 1 986 0.07 0.7865 *Because the interaction term, Diagnosis x Gender, is insignificant statistical analysis does not further examine the varying effects on the strength of the hand. Discussion of Strength Data Results obtained from the 2-Way ANOVA showed males had significantly stronger grip strength than females in both left and tight hands at a level of (1:001 (See Tables 8, 9 and 1 1). Subjects, both men and women, with arthritis had significantly lower grip strength than the people without arthritis at a level of a=0.01 (See Tables 8, 9 and 11). Significant differences existed in all possible pair-wise comparisons between arthritis and gender with regard to both hands (See Tables 10 and 12), with one exception. In a comparison of the gripping strength of the right hand of the females without arthritis and males with arthritis no significant difference existed upon comparison (See Table 10). The results were somewhat different for the data collected using the wrist dynamometer; for the right hand, gender was significant, diagnosis was not (See Table 13). For the left wrist measurements, gender was also proved significant at the a=0.01 level and diagnosis was not (See Table 15). However, all possible pair-wise comparisons of arthritis and gender were significant (See Table 16). Both diagnosis and gender proved statistically significant when the dependent variable was bilateral palm to palm squeeze (See Table 17). Once again, males are 52 stronger than the females, and patients with arthritis are weaker than the matched controls (See Table 8), however, this time there was no significant interaction between gender and diagnosis. Analysis of Size Information (Anthropometric Data) The functional grip diameters the diameter of the circle formed when the 1St and 2nd digits and 1S" and 3rd digits are in contact with each other, were determined by asking the subject to slide their hand as far down a cone shaped measuring device while still maintaining tip-to-tip contact (See Figure 27 and Table 18). Also, each subjects’ hand sizes were determined from digital pictures of the hands by measuring the width of the palm and the length of the index figure for both the right and left hands (See Figure 14, 15, 21 and Table 19) Table 18 - Average functional grip diameter (hand digit) in mm Category of Population and . . [number of Right (1-2) nght (1-3) Left (1-2) Left (1-3) people] Overall [100] 34.39 39.29 34.14 40.35 Men [10] 33.60 39.40 35.30 44.90 Women [90] 34.48 39.28 34.01 39.84 Men with ., Arthritis [5] 33.00 37.60 34.40 45.00 Men w/o Arthritis [5] 34.20 41.20 36.20 44.80 Women w/ arthritis [45] 33.29 37.51 32.38 37.96 Women w/o arthritis [45] 35.70 41.14 35.62 41.76 53 Table 19 — Average hand measurement in mm Category of P°pulanon and LH Palm LH Index RH Palm RH Index [number of people] Overall [100] 90.35 72.25 92.06 70.50 Men [10] 94.91 71.88 92.72 64.85 Women [90] 87.70 70.74 88.72 68.75 Men with Arthritis [5] 68.87 55.40 70.33 51.45 Men w/o Arthritis [5] 105.93 78.95 102.19 76.99 Women w/ arthritis [45] 88.14 70.02 90.60 68.61 Women w/o arthritis [45] 87.26 71.06 87.12 68.68 Analysis with Packages To quantify the difficulty in opening and closing medication containers, each subject was timed while opening and closing the medication containers that were described previously (see Table 3 and Figure 26). Three types of data were recorded: the ability of each participant to open and properly close a container, the length of time required to open and the time required to close, as well as any comments made by the participant regarding each container. Of the 10 different containers tested, NONE were opened by all subjects. Table 20 presents the number of subjects gable to open each of the different types of containers and the percentage of each type of population that was imable to open a given type. Table 21 presents the average time to open by package type and subject type. Figure 28 shows the average abort time for each package type. 54 Table 20 - Number of people within a category that could NOT open a given package type Q/o of given population unable to open a 'venflgn) Category and 20 20 24 24 24 28 28 38 45 45 [Number mm mm mm mm mm mm mm mm, mm mm of CT P&T CT * P&T SL CT P&T SL CT P&T Peoplg] Overall 10 48 6 46 40 1 25 33 3 10 [100] (10.0) (48.0) (6.0) (46.0) (40.0) (1.0) (25.0) (33.0) (3.0) (1011 Men 0 1 0 0 0 0 0 0 0 0 [le (0.0) (10) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) Women 10 47 6 46 40 1 25 33 3 10 [90] (11.1) (52.2) (6.7) (51.1) (44.4) (1.1) (27.8) (36.3 (3.3) (11.1) Men with 0 0 0 0 0 0 0 0 0 0 Arthritis (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) 151 Me“ 1”." 0 l 0 0 0 0 0 0 0 0 Arthritis [5] (0.0) (20.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) Women with 8 26 6 24 20 1 l4 l8 3 7 Arthritis (17.8) (57.8) (13.3) (53.3) (44.4) (2.2) (31.1) (40.0) (6.7) (15.6) [45] Women w/o 2 21 0 22 20 0 ll 15 0 3 Arthritis (4.4) (46.7) (0.0) (48.9) (44.4) (0.0) (24.4) (33.3) (0.0) (6.7) B5] 55 Table 21 - Average time to open a given design (in seconds) by subject type and package type sum“ 20 20 24 24 24 28 28 38 45 45 [number mm mm mm mm mm mm mm mm mm mm CT P&T CT P&T SL CT P&T SL CT P&T of people] overall 6.4 18.7 5.5 17.3 23.2 5.3 11.6 19.1 4.1 11.6 [100] I113? 6.6 21.3 5.0 21.0 18.6 4.4 8.5 29.7 4.4 8.6 W331“ 6.5 18.4 5.6 16.8 23.7 5.3 11.8 17.9 4.1 11.8 Men with Arthritis 5.9 17.9 4.6 14.4 15.4 4.0 8.0 22.1 3.7 7.6 [51 Men w/o Arthritis 3.5 15.0 3.5 11.3 9.4 3.3 6.3 13.0 3.5 4.8 [5] Women WM}. 70 192 55 177 248 51 99 191 41 121 Arthritis . . . . . . . . . . [45] Women “”0 38 131 45 131 152 47 134 137 33 89 Arthritis . . . . . . . . . . [451 Figure 28 - Average abort time for people unable to open a given package type in seconds 40 132‘ 3"9 31:3 30.1 8 20 4‘ 15.2 '7 of. _.__J .,L_.-_ . -1. - , 20 CT 20 PT 24 CT 24 PT 24 SL 28 CT 28 PT 38 SL 45 CT 45 PT AVG I When comparing the average opening time, the 20 mm, 28mm and the 45mm Push and Turn closures (P&T) were opened more slowly, on average, than the 56 Continuous Thread closures (CT) for all subject groups. The 24 mm size had three different designs, Squeeze Lok (SL), Continuous Thread (CT) closure and Push and Turn (P&T). For this size, the average opening time for the Squeeze Lok took the longest in all but one case; men without arthritis took slightly longer to open the Push and Turn (See Table 22). Table 22 - Design within each Size that was opened the Most Slowly $133333? 20 mm (CT 24 mm (CT, 28mm (CT vs. 38mm (4ng3: people] vs. P&T) P&T and SL) P&T) (SL) P &T) Overall [100] P&T SL P&T SL P&T Men [10] P&T P&T P&T SL P&T Women [90] P&T SL P&T SL P&T Men with Arthritis [5] P&T SL P&T SL P&T Men w/o Arthritis [5] P&T P&T P&T SL P&T Women with Arthritis 1451 P&T SL P&T SL P&T Women w/o Arthritis [451 P&T SL P&T SL P&T Table 23 presents the number of people that successfully opened a given closure design. Among the three designs (P&T, CT, and SL) when all participants were considered, the Continuous Thread (CT) had the overall highest success rate of opening (95%), followed by Push and Turn (P&T-67.8%) and Squeeze Lok (SL) had the lowest success rate of opening (63.5%) 57 Table 23 - Number of people within a category that successfully opened a given closure design (% a given population that successfully opened a given closure design) P&T CT [NuCfiihEzrfyPaenodple] (20mm, 24mm, (20mm, 24mm, (24mrrfL38mm) 28mm, 45mm) 28mm, 45mm) ’ Overall [100] 271(67.8) 380 (95.0) 127 (63.5) Men [10] 39 (97.5) 40 (100) 20 (100) Women [90] 232 (64.4) 340 (94.4) 107 (59.4) Men with Arthritis [5] 20 (100) 20 (100) 10 (100) Men w/o Arthritis [5] 19 (95) 20 (100) 10 (100) Women w/ arthritis [45] 109 (60.6) 162 (90.0) 52 (57.8) Women w/o arthritis [45] 123 (68.3) 178 (98.9) 55 (51.1) As mentioned, people that were able to successfully open a given type were then asked to re-secure the cap. Table 24 presents the average time to close by package type and subject type. When comparing the average closing time, the 20 mm, 28mm and the 45mm Push and Turn closures (P&T) were closed more slowly, on average, than the Continuous Thread closures (CT) for most subject groups. The exception to this was the group of men without arthritis, who took longer, on average, to close both the 28mm and 45mm Continuous Thread than the Push and Turn. As for the 24 mm size closures (Squeeze Loks, Continuous Threads and Push and Turns), the Squeeze Lok (SL) took the longest in all but one case; men with arthritis took slightly longer (0.1 second) to close the Push and Turn. (See Tables 24 and 25) 58 Table 24 - Average time to close a given design in seconds by subject type and [number of people] 20 20 24 24 24 28 28 38 45 45 Subjects mm mm mm mm mm mm mm mm mm mm CT P&T CT P&T SL CT P&T SL CT P&T Overall 2.9 3.5 3.3 3.5 4.8 2.9 4.4 4.6 3.2 4.9 [90] [52] [94] [54] [60] [99] [75] [67] [97] [90] Men 2.5 3.1 2.7 3.4 3.4 2.6 3.0 4.9 3.2 4.5 [101 [9] 1101 [10] [10] [10] [10] [10] [10] [10] Women 3.0 3.5 3.4 3.5 5.1 3.0 4.6 4.5 3.4 4.9 [80] [43] [84] [44] [50] [89] [65 L571 [87] [801 53:: 2.5 3.4 2.4 3.5 3.4 2.2 3.1 4.1 2.8 5.8 AWL, 151 151 151 151 151 151 151 151 151 151 Men w/o 2.5 2.8 3.0 3.3 3.4 3.0 2.9 5.7 3.7 3.2 Arthritis [5] [4] [5] [5] [5] [5] [5] [51 [5] [5 thiflfn 3.1 3.9 3.7 4.3 5.7 3.0 4.4 5.1 3.3 6.3 Arthritis [37] [19] [39] 121] [25] [44] [31] [27] [421 [381 wage“ 2.8 3.2 3.2 2.9 4.4 3.0 4.8 4.0 3.0 3.7 Arthritis [43] [24] [45] [23] [25] [45] [34] [30] [45] [42] Table 25 - Design (Within each Size) that was Closed the Most Slowly and [number of peo leL Subjects 20 mgl&(CT vs. 24 mm (CT, 28mm (CT 38mm :33: T) P&T and SL) vs. P&T) (SL) P &T) Overall P&T [142] SL [208] P&T [174] SL [67] P&T [90] Men P&T [l9] P&T, SL [30] P&T [20] SL [10] P&T [10] Women P&T [123] SL [178] P&T [154] SL [57] P&T [80] Men with Arthritis P&T [10] P&T [15] P&T [10] SL [5] P&T [5] Men w/o Arthritis P&T [9] SL [15] CT [10] SL [5] CT [5] Women with P&T [56] SL [85] P&T [75] SL [27] P&T [38] Arthritis Women w/o P&T [67] SL [93] P&T [79] SL [30] P&T [42] Arthritis 59 Table 26 presents number of people within a category that could not close a given package type and Table 27 presents the number of people within a category that successfully closed a given design. Overall the SL style had the lowest success rate of closing; 18.3% of those that attempted couldn’t close a 24mm SL properly and 13.4% for the 38mm SL. Table 26 - Number of people within a category that could NOT close a given design (”A of a iven population unable to close a given type 20 20 24 24 24 28 28 38 45 45 Category mm mm mm mm mm mm mm mm mm mm CT P&T CT P&T SL CT P&T SL CT P&T Overall 0/90 0/52 2/94 1/54 11/60 0/99 2/75 9/67 0/97 1/90 (0.0) (0.0) (2.1) (1.9) (18.3) (0.0) (2.7) (13.4) (0.0) (1.1) Men 0/10 0/9 1/10 0/10 2/10 0/10 0/10 3/10 0/10 0/10 (0.0) (0.0) (10.0) (0.0) (20.0) (0.0) (0.0) (30.0) (0.0) (0.0) Women 0/80 0/43 1/84 1/44 9/50 0/89 2/65 6/57 0/87 1/85 (0.0) (0.0) (2.4) (2.3) (18.0) (0.0) (3.1) (10.5) (0.0) (1.2) Menwith 0/5 0/5 0/5 0/5 2/5 0/5 0/5 0/5 0/5 0/5 Arthritis (0.0) (0.0) (0.0) (0.0) (40. 0) (0.0) (0.0) (0.0) (0.0) (0.0) Menw/o 0/5 0/4 1/5 0/5 0/5 0/5 0/5 3/5 0/5 0/5 Arthritis (0.0) (0.0) (20.0) (0.0) (0.0) (0.0) (0.0) (60.0) (0.0) (0.0) W»??? 0/37 0/19 0/39 1/21 2/25 0/44 1/31 3/27 0/42 1/38 Arthritis (0.0) (0.0) (0.0) (4.8) (8.0) (0.0) (3.2) (6.4) (0.0) (2.6) war/26“ 0/43 0/24 1/45 0/23 7/25 0/45 1/34 3/30 0/45 0/42 Arthritis (0.0) (0.0) (2.2) (0.0) (28.0) (0.0) (3.0) (1.0) (0.0) (0.0) 60 Table 27 - Number of people within a category that successfully closed a given closure design 3% of a given population successfully closed a iven closure desing P&T (20mm, 24mm, CT (20mm, 24mm, Category 28mm, 45mm) 28mm, 45mm) SL (24mm, 38mm) Overall 267 / 271 (98.5) 378 / 380 (99.5) 107/ 127 (84.3) Men 39 / 39 (100) 39 / 40 (97.5) 15 / 20 (87.5) Women 228 / 232 (98.3) 339 / 340 (99.7) 92 / 107 (86.0) Men with Arthritis 20 / 20 (100) 20 / 20 (100) 8 / 10 (80.0) Men w/o Arthritis 19/ 19 (100) 19 / 20 (95.0) 7 / 10 (70.0) Women w/ l 'tis 106/ 109 (97.2) 162/ 162 (100) 47 / 52 (90.4) Women w/o arthritis 122/ 123 (99.2) 177/ 178 (99.4) 45 / 55 (81.8) Closing is an important feature of child resistant packaging because it allows subjects to re-secure the cap; a design that cannot be properly re-engaged is essentially no longer CR. In addition to the time to close, researchers also took note of incidents where CR features were not properly re-engaged. Results of this analysis are discussed in sections that follow. Statistical Analysis of Data Collected on Package Openings and Closings Both attribute data (package successfully opened-yes or no; package successfully closed-yes or no) and variable data (time to open, time to close) were recorded as outcome variables. Data was analyzed using two techniques. Split-Plot Design The experiment was first analyzed using a split-plot design. The whole plot factor was diagnosis (cases vs. controls) and a subplot factor that contained all possible combinations of child resistance (yes or no), type (the 10 containers), shape (round vs. 61 square) and size (large, medium and small) was used. All effects were treated as fixed effects. The results from this analysis are considered in the discussion presented here. A second analysis, which included covariate variables, variables that were determined at the subject level with the tests of hands, mental ability, etc. . ., is presented in Appendix H. Analysis of variance (ANOVA), by means of SAS Proc Glimmix, was used to examine the significant effects on the outcome variables (package successfully opened- yes or no and time to open; time to close). In the model statement, the outcome variables (time to open, time to close) were assumed to be normally distributed, and the attribute data for the outcome variables (package successfully opened- yes or no; package successfully closed- yes or no) were assumed to have a binary distribution. Residual plots for continuous variables (time to open, time to close) were produced to test the distribution assumptions. Based on the residual plots, the time to open, and the time to close variables were transformed using the natural log and the analysis was conducted using the logged variables; this was true for both analyses. Statistical Analysis of Opening Data: Split-Plot Design —Varl'able Data (Time to open) To analyze the data, first a split-plot design was employed. (See Table 28A) The split plot design treated time to open as the response variable (dependent variable) and the following factors as fixed effects: 0 Diagnosis (arthritis vs. control, see Table 5) 0 Type (The individual 10 containers tested) (See Figure 19) 0 Diagnosis x Type 62 0 Gender (male vs. female) 0 Type x Gender 0 Diagnosis x Gender The effect of design (P&T, SL, CT), and size (Small, Medium, Large) on the time to open was also considered. (See Table 28B) Table 28A - Results of Split Plot: Resultant variable is Time to Open-All Effects are considered Fixed Effects (Size groupings based on Finish Diameters provided b the Bottle Manufacturer) Effect Num DF Den DF F Value Pr>F Diagnosis 1 84.4 6.99 0.0098 Type 7 . 654 54.64 <.0001 D‘ag‘ms‘s x 7 663 1.20 0.3009 Type Gender 1 86.1 3.08 0.0826 Type x Gender 7 654 1.32 0.2400 D‘agnos‘s x 1 82.6 0.00 0.9497 Gender Table 288 - Analysis of varying effects on Time to Open- (Size groupings based on Finish Diameters provided by the Bottle Manufacturer) Effect Estimate Standard DF t Value Pr > |t| Enor Non-CR CT vs. CR -1.0290 0.05716 656 -18.00 <0.0001 desiggs CT vs. P&T -0.8983 0.06353 656 -14.14 <0.0001 P&T vs. SL -0.3319 0.07594 ,655 .4.37 <0.0001 CT vs. SL -1.2302 0.07474 656 -16.46 <0.0001 small VS“ -0.05298 0.07361 654 -072 0.4719 Medium small VS' 0.08858 0.07832 654 1.13 0.2585 Large Medmm VS' 0.1416 0.06286 654 2.25 0.0246 large Bolded Effects were indicated to be significant at a level of 0.01. In addition to the groupings of small, medium and large that were based on neck finish (see Figure 19 and Table 28 A and B), it was decided that a more appropriate measure of the effect of size would actually be the outside diameter of the closure (COD- 63 see Table 4 and Appendix F). As such, researchers re-categorized the packages by using the CODs into 3 different sizes (Small: 20mm CT, 20mm PT, and 24mm CT; Medium: 24mm PT, 24mm SL, 28mm CT, and 28mm PT; Large: 38mm SL, 45mm CT, and 45mm PT). (See Table 4 and Appendix F) Statistical analysis was repeated with new set of size data based on the COD (See Tables 4, 29A and 29B) Table 29A - Results of Split Plot: Resultant variable is Time to Open-All Effects are considered Fixed Effects (Size groupings based on Outside Diameter of the Closure) Effect Num DF Den DF F Value Pr>F Diagnosis 1 84.4 6.36 0.0135 Type 7 654 54.68 <.0001 D‘agnos‘s x 7 663 1.17 0.3159 Type Gender 1 86.1 3.29 0.0730 Type x Gender 7 654 1.33 0.2344 D‘agnos‘s x 1 82.7 0.00 0.9499 Gender on Outside Diameter of the Closure Table 29B - Analysis of varying effects on Time to Open (Size groupings based Effect Estimate Standard DF t Value Pr > It] Error Non-CR CT vs. CR -l.0422 0.05691 657 -18.31 <0.0001 designs CT vs. P&T -0.9115 0.06330 656 -14.40 <0.0001 P&T vs. SL -0.3320 0.07593 655 .4.37 <0.0001 CT vs. SL -1.2434 0.07455 656 -16.68 <0.0001 small VS' -0.04562 0.07016 654 -0.65 0.5157 Medium small VS’ 0.08521 0.07259 655 1.17 0.2409 Large Man“ vs' 0.1308 0.06572 653 1.99 0.0469 large Bolded Effects were indicated to be significant at a level of 0.01. 64 Statistical Analysis of Closing Data: Split-Plot Design —Variable Data (Time to close) Analyses were repeated for time to close (see Table 30A).The effect of design (P&T, SL and CT), and size (Small, Medium, Large) on the time to close was also considered (See Table 30B). by the Bottle Manufacturer) Table 30A - Results of Split Plot: Resultant variable is Time to Close-All Effects are considered Fixed Effects (Size groupings based on Finish Diameters provided Effect Num DF Den DF F Value Pr>F Diagnosis 1 80.8 0.56 0.4575 Typ_e 7 652 9.03 <0.0001 D’agr‘OS‘S x 7 662 0.76 0.6246 Type Gender 1 82.7 2.67 0.1058 Type x Gender 7 652 1.00 0.4269 D‘agnos‘s x 1 78.7 2.43 0.1230 Gender Table 30B — Analysis of varying effects on Time to Close (Size groupings based on Finish Diameters provided by the Bottle Manufacturer) Effect Estimate Standard DF t Value Pr > M Error Non-CR CT vs. CR -0.2861 0.04244 654 -6.74 <0.0001 designs CT vs. P&T -0.2113 0.0417 654 -4.48 <0.0001 P&T vs. SL -0.1864 0.05639 653 -3.31 0.0010 CT vs. SL -0.3977 0.05550 654 -7.17 <0.0001 small V3“ 01068 0.05466 652 -1.95 0.0512 Medium 3”" VS' -0.2053 0.05816 652 -3.53 0.0004 Large Med‘m“ VS' -0.09854 0.04668 651 -211 0.0352 large Bolded Effects were indicated to be significant at a level of 0.01. 65 Analyses were once again repeated for time to close based on COD of the packages (see Table 31A). The effect of design (P&T, SL and CT), and size based on COD (Small, Medium, Large) on the time to close was also considered (See Table 31B). Table 31A - Results of Split Plot: Resultant variable is Time to Close-All Effects are considered Fixed Effects (Size groupings based on Outside Diameter of the Closure) Effect Num DF Den DF F Value Pr>F Diagnosis 1 80.8 0.43 0.5159 Type 7 652 9.07 <.0001 D‘agms‘s x 7 662 0.99 0.4350 Type Gender 1 82.8 2.58 0.1123 Type x Gender 7 652 1.06 0.3904 D‘agnos‘s x 1 78.9 2.45 0.1213 Gender Outside Diameter of the Closure) Table 31B - Analysis of varying effects on Time to Close (Size groupings based on Effect Estimate Standard DF t Value Pr > It| Error Non-CR CT vs. CR -0.2862 0.04212 655 -6.80 <0.0001 designs CT vs. P&T -0.2114 0.04685 654 -4.51 <0.0001 P&T vs. SL -0.1864 0.05620 653 -3.32 0.0010 CT vs. SL -1.5207 0.05518 654 -3.30 <0.0001 small VS“ 0.07491 0.05194 652 ' -144 0.1497 Medium 8”" ”5' -0.1861 0.05373 653 -3.46 0.0006 Large Med‘“ ”5' -01112 0.04865 651 -229 0.0226 large Bolded Effects were indicated to be significant at a level of 0.01. Discussion of Variable Data (Time to Open and Time to Close) Opening Data As mentioned previously, when comparing the average opening time, the 20 mm, 28mm and the 45mm Push and Turn closures (P&T) were opened more slowly, on average, than the Continuous Thread closures (CT) for all subject groups (See Table 22). 66 The 24 mm size had three different designs, Squeeze Lok (SL), Continuous Thread and Push and Turn. For this size, the average opening time for the Squeeze Lok took the longest in all but one case; men without arthritis took slightly longer to open the Push and Turn. (See Table 21) Among the 6 CR containers, 5 containers had 25 or more people fail to open the containers, compared to non-CR containers which had no more than 10 people fail in each of the 4 designs (See Table 20). Of a total attempts of 600 (6 CR designs x 100 people), 202 failed to open (See Table 20). This represents 33.7% of the attempted openings for the CR set. This is a significant finding as the Keram study conducted prior to the change in protocol produced similar results. (See section entitled Child Resistant Containers in the Hands of People with Arthritis). In addition, participants took, on average, a longer time to open CR containers than non-CR containers (See Table 21). The shortest mean opening time among the CR containers, 11.6 sec (28mm and 45mm P&T), was approximately 65% longer than the shortest mean opening time among the containers without CR features (4.1 sec — 45mm CT). Using the split plot design to analyze the variable data, both diagnosis and package type were found to have a significant impact on time to open at a level of or=0.01 (see Table 28A). Patients with arthritis took a longer time to open 9 out of the 10 packages, on average, than the patients without arthritis. The exception was the 28mm P&T (see Table 21). When the package designs were analyzed using pair wise comparisons (See Table 28B), the following comparisons were statistically significant at a level of 01=0.01. Child resistant designs (P&T and SL) took significantly longer to open than did the non—CR 67 design (CT). P&Ts took significantly less time to open than did CTs. Both CTs and P&Ts took significantly less time to open than did SL. Size (small, medium, large) and gender did not have a significant effect on the time to open packages. As mentioned above, researchers had concerns that packages categorize into 3 different sizes (Small, Medium, Large) using the neck finishes did not truly capture the interface. Therefore, researchers re-categorized the packages by using the closure outside diameters (CODs). Bottles were grouped into 3 different sizes (Small: 20mm CT, 20mm PT, and 24mm CT; Medium: 24mm PT, 24mm SL, 28mm CT, and 28mm PT; Large: 38mm SL, 45mm CT, and 45mm PT). (See Table 4 and Appendix F) The significant differences that existed with regard to size (small vs. medium, medium vs. large and small vs. large) remained identical to the previous analysis that used the finish diameter. (see Tables 28 A and B and 29 A and B). When comparing the remaining results, significant factors remained the same, with one exception. In the second analysis, which employed the COD as opposed to the finish diameters of the bottles, diagnosis was no longer significant. This is the result of changes in the error associated with the new model. Closing Data When comparing the average closing time for the 20 mm Push and Turn closures (P&T) and the Continuous Thread (CT) closures, P&Ts were closed more slowly, on average, than the Continuous Thread closures (CT) for all subject groups. The 24 mm size had three different designs, Squeeze Lok (SL), Continuous Thread and Push and Turn. For this size, the average closing time for the Squeeze Lok took the longest in all 68 but one case; men with arthritis took slightly longer to open the Push and Turn. (See Table 24) For the 28 mm size closures (P&T and CT), the average closing time for the P&T was longer than the CT for all but one case, men without arthritis. For the 45 mm, which contained both P&T and CT closures, the P&T took more time, on average to close than did the CT for all groups with the exception of men without arthritis (See Table 23). There were total of 26 containers that were not properly closed. (See Table 27) Of these, 24 were containers with a CR function; 20 were SL designs. Of the CR designs (the 24mm P&T, the 24mm SL, the 28mm P&T, the 38mm SL and the 45mm P&T,) all had incidents where subjects did not properly engage the CR feature when they were asked to re-close the package. Only the 20mm P&T, which performed poorly in the opening test (see Table 20), was re-secured properly by all who opened it. In addition, participants took, on average, a longer time to close CR containers than non-CR containers (Table 24). The shortest mean closing time among the CR containers, 3.5 sec (20 and 24 mm P&T), was approximately 17% longer than the shortest mean opening time among the containers without CR features (2.9 sec- 20 and 28 mm CT). Using the split plot design to analyze the variable data, only package type was found to have a significant impact on time to close at a level of 01:0.01 (see Table 30A). When the package designs were analyzed using pair wise comparison (See Table 30B), the following comparisons were statistically significant at a level of 01:0.01. CR designs (P&T and SL) took significantly longer to close than did the non-CR design (CT). 69 P&Ts took significantly less time to close than did SLs. Both CTs and P&Ts took significantly less time to close than did SLs. As before, the analysis was repeated by grouping size data based on the COD for time to close based on COD (see Tables 30B and 31B). These were compared with the previous analysis for time to open, based on size groupings of bottle finish (see Tables 30A and 30B); all results were identical in terms of significance. Statistical Analysis of Opening Data Split-Plat Design - Analysis of the Attribute Data (Package Successfully Opened- Yes or No) The analyses were repeated for the attribute data (package successfully opened -- yes or no) with the following results (See Table 32A - note- no cross comparison between diagnosis, type and gender due to the statistical design). The effect of design type (P&T, SL and CT), and size (Small, Medium, Large) on the attribute data was further refined so that pair-wise comparisons could be made (See Table 32B). 70 Diameters provided by the Bottle Manufacturer) Table 32A - Results of Split Plot: Resultant variable is Package Successfully Opened-All Effects are considered Fixed Effects (Size groupings based on Finish Effect Num DF Den DF F Value Pr>F Diagnosis 1 97 2.01 0.1595 Type 7 888 20.52 <0.0001 Gender 1 888 9.54 0.0021 Table 32B - Analysis of varying effects on Package Successfully Opened (Size groupings based on Finish Diameters provided by the Bottle Manufacturer) Effect Estimate Standard DF t Value Pr > It] Enor Non-CR CT vs. CR -3.0357 0.3298 888 -9.20 <0.0001 designs CT vs. PT -2.8195 0.3444 888 -8.19 <0.0001 PT vs. SL -0.5602 0.2516 888 -223 0.0262 CT vs. SL -3.3797 0.3634 888 —9.30 <0.0001 small ”5' 0.3462 0.2902 888 -1.19 0.2332 Medium 5”" VS“ 1.3350 0.3518 888 -3.79 0.0002 Large Med'“ “5' 0.9888 0.3183 888 3.11 0.0020 large Bolded Effects were indicated to be significant at a level of 0.01. The analyses were again repeated for the attribute data (package successfully opened «yes or no) based on the new set of size data (COD) with the following results (See Table 33A - note- no cross comparison between diagnosis, type and gender due to the statistical design). The effect of design type (P&T, SL and CT), and size based on COD (Small, Medium, Large) on the attribute data was further refined so that pair-wise - comparisons could be made (See Table 33B). 71 Table 33A - Results of Split Plot: Resultant variable is Package Successfully Opened-All Effects are considered Fixed Effects (Size groupings based on Outside Diameter of the Closure) Effect Num DF Den DF F Value Pr>F Diagnosis 1 97 2.01 0.1595 Type 7 888 19.65 <0.0001 Gender 1 888 9.51 0.0021 Table 33B - Analysis of varying effects on Package Successfully Opened (Size groupings based on Outside Diameter of the Closure) Effect Estimate Standard DF t Value Pr > M Error Non-CR CT vs. CR -3.6424 0.4681 888 -7.78 <0.0001 designs CT vs. PT -3.4261 0.4783 888 -7.16 <0.0001 PT vs. SL -0.5605 0.2518 888 -223 0.0263 CT vs. SL -3.9866 0.4927 888 -8.09 <0.0001 small VS' 0.6794 0.4242 888 1.60 0.1096 Medium 8m" ”5' 1.1853 0.3315 888 3.58 0.0004 Large Madmm VS' 0.5059 0.4576 888 1.11 0.2693 large Bolded Effects were indicated to be significant at a level of 0.01. Discussion of the Attribute Data (Package Opened Successfully? Package Closed Successfully?) As mentioned previously, among the 6 CR containers, 5 containers had 25 or more people fail to open the containers, compared to the non-CR containers, which had no more than 10 people fail in each of the 4 designs (Table 20). The people who failed to open the packages took an average of 24.95 seconds to abort (See Figure 28). Among the 4 P&Ts (20mm, 24mm, 28mm, 45mm), subjects who failed to open the packages all tried more than 30 seconds before aborting attempts. When the results were grouped using the three closure designs: Push and Turn (P&T), Continuous Thread (CT) and Squeeze Lok (SL), the CTs had the overall highest 72 success rate of opening of 95%, followed by the P&Ts (67.8%) while the SL5 had the lowest success rate of opening of 63.5%. (See Table 23) Among genders, men had a higher average success rate of opening across all three designs (P&T, CT, SL). Women participants only had average 64.4% success rate of opening in the P&Ts and 59.4% in SLs, compared to a much higher success rate of opening in the CTs (94.4%). Additionally, when comparing diagnosis by genders across the three closure designs (P&T, CT, SL), men with and without arthritis both did well at opening all three closure designs; only one male subject without arthritis failed to open a P&T design. However, the females had very different results. Women without arthritis had a higher success rate of opening in both P&Ts (68.3%) and CTs (98.9%) than females with arthritis (P&T: 60.6%, CT: 90%). In the SL design, women with arthritis had a better success rate of opening (57.8%) than the controls (51.1%). There were a total of 26 containers that were not properly closed. (See Table 27) Of these, 24 were containers with a CR function. SL closures performed the worst on closing; 18.3% of the subjects couldn’t properly close a 24mm SL and 13.4% couldn’t properly close a 38mm SL. When comparing the success rates of closing across the three different closure designs (P&T, CT, and SL), all participants had over a 95% success rate of closing in both the PT and CT packages. (See Table 26) Only 84.3% of the SL packages were successfully closed. The attribute opening data was analyzed by using a split plot design similar to the statistical analysis done for the variable opening and closing data. However, no cross comparison between diagnosis type and gender were made. Diagnosis was found to be insignificant when considering the number of openings. Both package type and gender 73 were found to have a significant impact on whether or not a package was successfully opened (see Table 32A). When package designs were analyzed using pair wise comparisons (See Table 328), the following comparisons were statistically significant at a level of 01:001. CR designs (P&T and SL) were significantly harder to open than the non-CR design (CT). Size showed a significant effect on number of openings (small vs. large, medium vs. large). When the packages were regrouped by COD into 3 different sizes, the data was once again analyzed by using a split plot design. All effects that were significant in the analysis that was based on finish size remained at the same level of significance with one exception. In the analysis that was based on finish size (see Table 32 A and B), significant differences existed between the small and large groupings and the medium and large groupings. However, when the analysis was repeated using the COD to group the packages into “small, medium and large,” significant differences existed only between the small and large groups. No significant differences existed when comparing the number of openings between the small and large and the medium and large groups. 74 Survey Data Table 34 - Survey information Category of Satisfaction Satisfaction Importance of Performance Population and W/ ablhty to w/ your managing you on managing [number of manage your ability to open own your own people] own. CR packages medications medications medications Overall U00] 8.6 6.1 9.5 8.7 Men [10] 9.2 8.1 9.6 9 Women [90] 8.5 5.9 9.5 8.7 Men with ArthritifiS] 10 9.2 10 9.8 Men w/o Arthritis [5] 8.3 6.8 9 8 Women with Arthritis [45] 8 5 9.4 8.3 Women w/o Arthritis [45] 9 6.6 9.6 9 Table 35 - Number of people within a category who were aware they could request/purchase medications in non-CR format (% of a given population aware request/purchase medications in non-CR format) - - Awareness of the [number ofpeople] CR format from the pharmacist OTC’ m a non-CR format Overall [100] 70 Q0%) 40 (40%) Men [10] 6 (60%) 4 (40%) Women [90] 64 (71.1%) 36 (40%) Men with Arthritis [5] 5 (100%) 3 (60%) Men w/o Arthritis [5] 1 (20%) 1 (20%) Women with Arthritis [45] 34 (75.6%) 18 (40%) Women w/o Arthritis [45] 30 (66.7%) 18 (40%) Discussion of Survey Data During the brief rest period, which occurred between the two tests of 5 packages each (See Table 2), OT researchers questioned subjects about: their satisfaction with their ability to manage their own medications; the importance of managing their own 75 medications; their performance with managing their own medications; and their satisfaction with their ability to open CR packages. The responses were recorded on a scale of 1-10, where 10 was the most positive response. Overall, subjects were satisfied (an average response of 8.6 out of 10) and performed well (an average response of 8.7 out of 10) regarding managing their own medications, and they also realized the importance of managing their medications (9.5 out of 10). But subjects weren’t satisfied with opening CR packages; a mean score of 6.1 (out of 10) was found (See Table 34) Subjects also were asked, “how many medications do you take daily?” (See Table 6), whether or not they opened their own medications (See Table 7), and whether or not they were aware that they could request prescription medications in non-CR formats or purchase OTC s in non-CR formats (See Table 35). Khanderia et a1. (1980) surveyed 330 senior citizens and indicated that 37% were unaware that they could request a non-CR container from the pharmacist. (36) The survey presented here provides similar results, indicating that, 30% of the subjects were unaware that they could request their medication in non—CR format from the pharmacist, and 60% of the subjects unaware they could purchase medication over-the-counter (OTC) in non-CR formats (see Table 35). 76 CONCLUSION Table 36- Summary of results for hypotheses based on statistical analyses **** . Variable Opening Attribute Opening Variable Closing Hypothes1s Data Data Data There is no effect of subject (arthritic vs. control) on the . . . number of openings or the time Regengigtn- Fail to reject the Fallfififfi‘: the to open or close packages; cases Difference at null- No significant 51 ificant and controls will be able to 0 01 difference at 0.01 differgerrlice at 0 01 access and close desrgns With (see Table 28 A) (see Table 32A) (see Table 3 0 A) equal ease. There is no effect of gender Fail to reject the . Fail to reject the (male vs. female) on the null- No Reéicrtrittlisalir‘iu- null- No number of openings or the time significant . g significant . difference at 0.01 . to open or close packages. difference at 0.01 (see Table 32 A) difference at 0.01 (see Table 28A) (see Table 30A) There is no effect of CR on the number of openings or the time Reject the null— Re’ect the null- Reject the null- to open or close: CR designs Significant Si ni fican t Significant will be opened and closed as difference at . g difference at . difference at 0.01 frequently and quickly as non- 0.01 (see Table 32B) 0.01 CR designs. (see Table 28B) (see Table 30B) There is no effect of design on the number of openings or the . . time to open or close; each of Rel?“ the null- Reject the null- Reject the null- . . Significant . . Significant the three desrgns Will be opened difference at Significant difference at with the same frequency and 0 01 difference at 0.01 0 01 require equal amounts of time ° (see Table 32B)* ' (see Table 28B) (see Table 308) to open. There is no effect of size on the number of openings or the time . . _ , Fail to reject the to open or close. To analyze Fallgzlffig the Regfc;it£:al:ll- null- No this hypothesis packages will be 51 i ficant difference at Significant grouped into three sizes (small, differgeiice at 0 01 0 01" difference at medium and large) due to the (see Table 28B) (see Table 32B) 0.01“” fact that inconsistent diameters (see Table 30B) were received. Bolded results indicate statistically significant differences at a=0.01 * All comparisons were significant except for the P&T when compared with the SL ”Small vs. medium was not significant; small vs. large and medium vs. large were ***No significant difference in small vs. medium or medium vs. large; small vs. large was significant ”"It is important to note that these results are based on the original groupings of the packages based on finish sizes provided by the bottle manufacturers. Additional analysis was conducted that regrouped packages based on outside diameters of the closures. These results are presented elsewhere in the thesis. 77 CONCLUSION Table 36- Summary of results for hypotheses based on statistical analyses **** . Variable Opening Attribute Opening Variable Closing Hypothesrs Data Data Data There is no effect of subject (arthritic vs. control) on the . . . number of openings or the time Refiiciiitl‘iial‘riltm- Fail to reject the Fallgglfjfig the to open or close packages; cases Difference at null- No significant si ificant and controls will be able to 0 01 difference at 0.01 differiriice at 0 01 access and close desrgns With (see Table 28 A) (see Table 32A) (see Table 3 0 A) equal ease. There is no effect of gender Fail to reject the Re'ec t the null— Fail to reject the (male vs. female) on the null- No Si nifican t null- No number of openings or the time significant differgence at 0 01 significant to open or close packages. difference at 0.01 (see Table 32A) difference at 0.01 (see Table 28A) (see Table 30A) There is no effect of CR on the number of openings or the time Reject the null— Re'ect the null- Reject the null- to open or close: CR designs Significant Si ni fican t Significant will be opened and closed as difference at differgence at 0 01 difference at frequently and quickly as non- 0.01 (see Table 321'” 0.01 CR designs. (see Table 288) (see Table 308) There is no effect of design on the number of openings or the . . time to open or close: each of Rel?“ the null- Reject the null- Rel?“ the null- . . Significant . . Significant the three desrgns Will be opened difference at Significant difference at with the same frequency and 0 01 difference at 0.01 0 01 require equal amounts of time ' (see Table 328)* ' (see Table 288) (see Table 308) to open. There is no effect of size on the number of openings or the time Fail to reject the Reject the null— Fail to reject the to open or close. To analyze null- No Si ni fican t null- No this hypothesis packages will be $1 ificant difference at Significant grouped into three sizes (small, di fferilrice at 0 01 0 01" difference at medium and large) due to the (see Table 288) (see Table 328) 0.01*** fact that inconsistent diameters (see Table 308) were received. Bolded results indicate statistically significant differences at a=0.01 * All comparisons were significant except for the P&T when compared with the SL "Small vs. medium was not significant; small vs. large and medium vs. large were ***No significant difference in small vs. medium or medium vs. large; small vs. large was significant ****It is important to note that these results are based on the original groupings of the packages based on finish sizes provided by the bottle manufacturers. Additional analysis was conducted that regrouped packages based on outside diameters of the closures. These results are presented elsewhere in the thesis. 77 No significant difference was found regarding the number of openings when comparing patients with arthritis and matched controls; however, among those that successfully opened the packaging, a statistical difference did exists between the amount of time that it took patients with arthritis and the matched controls. No difference was found regarding the time that it took people with arthritis and the matched controls to close the packages. This, quite possibly, could be because the patients with arthritis self- reported a doctor’s diagnosis that was not confirmed by the research team diagnostically. When comparing male and female subjects, statistically significant differences were found in the ability to successfully open the packages (with males enjoying a greater success rate), but of those that were successful, no difference was found in the time that it took them to open. Likewise, no statistically significant difference was found when comparing the time that it took each of the genders to close the packages. Readers are cautioned to remember that the number of males in the sample was quite limited; further research is warranted. Not surprisingly, when child resistant designs were compared to non-child resistant designs all analyses proved significantly different; more non-child resistant designs were successfully opened than child resistant designs. When comparing those that were successful, non-CR designs were opened, and closed, significantly faster than their CR counterparts. When comparing the specific designs (P&T, SL and CT), significant differences existed when comparing all designs for both number of successful openings with one exception, the number of successful openings of the P&T and the SL did not vary significantly. With regard to the time to open, CTs were opened the quickest, followed 78 by the P&T design, while the SL took the longest for participants. Closing data also followed the same pattern; the CT was closed the quickest, followed by the P&T and the SL took significantly longer than the other designs. This is quite possibly due to the prevalence of the P&T closures in the marketplace; consumers have become familiar with the mechanism and, therefore, are quicker to open and close designs of this nature. The size of the systems was also compared alter containers were grouped into “small, medium and large” (see Figure 19). Size did not influence the time to open. The only significant effect found in the time to close was when the small and large containers were compared. It took significantly longer to close the large packages than it did the small ones. Size did impact the number of successful openings; the small vs. the large and the medium vs. large proved to be statistically different comparisons. Larger containers were opened more frequently than their smaller counterparts. One of the key drivers of this study was to attempt to evaluate the effectiveness of the change in the CPSC protocol that was published in 1995 and took effect in 1998. In order to attempt to draw relevant comparisons, many of the study’s factors (time to open, time to close, the set up of the subject, etc.) were based on the 1988 study published by Keram et al. (33) The results for this study (post protocol change) were surprisingly similar to their findings in 1988 (pre change). As mentioned, Keram et al. (1988) reported that “slightly more than 30% of participants” were unable to open the CR designs that they tested.” This is consistent with results presented here; of an attempted 600 CR openings (6 CR designs x 100 subjects), 202 attempts were unsuccessful (33.7%). This would seem to suggest that the protocol has not made a significant impact on package design. 79 However, it should be noted that the study presented here purposefully included people that self-identified as being diagnosed with arthritis by a doctor. The 1988 study did not. As such, researchers reexamined the results, limiting the data analysis to those without a doctor’s diagnosis, the matched controls. In an attempted 300 openings of CR systems (6 types x 50 people), 93 people were not able to successfully open the designs (31%); again, consistent with the findings from nearly 20 years ago, suggesting that the change in protocol has not dramatically changed the ease of use of these packages for older consumers. Results suggest that further work is needed to ensure that people with arthritis are able to access their medications. Perhaps most alarming is the fact that not a single closure, even when non-CR designs were considered, was opened by every subject tested, despite the fact that all live independently and administer their own medications. Further investigation into this issue is warranted and design criteria that consider people with arthritis are needed. 80 RECOMMENDATIONS AND FUTURE STUDIES 0 In the original proposal, 3 different designs of closures (2 CRs and 1 non-CR) in 4 different diameters were proposed. However, due to limitations of the market this goal was not achieved. Prototyping could be an option to resolve this issue in order to have a balanced design of experiments for future projects. 0 All packages (bottles and closures) used in the future should be all made of same material, same shape and color. As mentioned previously, attempts were made to do so in this study, however, market availability limited the choices that were possible. 0 It is recommended that the study be repeated using a wide array of packages found in the ASTM classification to see how arthritis patients perform when opening and closing them. Ranking ease of use of each packages presented in the research is recommended. 0 More details about the condition of the arthritis in hands are needed for future research. Closer consultation with a rheumatolo gist is recommended, and the degree of impairment could be further confirmed using X-Ray or other diagnostic techniques. 0 More male. participants should be included in future studies to have a better balance between genders. It is also recommended that future studies further classify recruitment locations so that a deeper understanding of the living conditions can be developed. For example, if a subject is recruited from a luxury senior community with an aide standing by, even though the subject is able to perform the activities of daily life, the aide can be called for help. However, 81 subjects that live in poorer conditions frequently do not have access to such help. This begs the question, “Do poorer subjects develop different coping skills when facing the task of package opening”? Anecdotally, the research team noted that at one subsidized housing location of recruitment for this study, seniors had been discussing the presented research and “instructing” each other on the opening of a bottle of mouth wash that one subject had brought to illustrate the difficulties that she had. No such observation was made at the more affluent senior apartments that provided aides to residents. Repeating the study with an expanded range of disabilities would provide insights into coping strategies that are employed, and the difficulties that people have with current CR packaging. Ethnographic research regarding coping strategies and difficulties that people have with current packaging is recommended. This would enhance our understanding of how people open packages, store medications, navigate directions and use tools. 82 Appendix A - UCRIHS Approval MICHIGAN STATE Initial IRB U N I V E R S l T Y Application Approval October 25, 2005 T02 Laura BIX 153 Packaging Building Re: IRB # 05-819 Category: EXPEDITED 2-4,2-6 Approval Date: October 25, 2005 Expiration Date: October 24, 2006 Title; CHILD RESISTANT DRUG PACKAGING AND ARTHRITIS: CAN PEOPLE WITH ARTHRITIS ACCESS THEIR MEDICATIONS? The University Committee on Research Involving Human Subjects (UCRIHS) has completed their review of your project. I am pleased to advise you that your project has been approved. The committee has found that your research project Is appropriate in design. protects the rights and welfare of human subjects. and meets the requirements of MSU's Federal Wide Assurance and the Federal Guidelines (45 CF R 46 and 21 CFR Part 50). The protection of human subjects in research is a partnership between the IRB and the investigators. We look forward to working with you as we both fulfill our responsmilities. Renewals: UCRIHS approval is valid until the expiration date listed above. If you are continuing your project, you must submit an Application for Renewal application at least one month before expiration. II the project is completed. please submit an Application for Permanent Closure. Revisions: UCRIHS must review any changes in the project prior to initiation of the change Please submit an Application for Revision to have your changes reviewed If changes are made at the time of renewal please include an Application for Revision with the renewal application. Problems: lf issues should arise during the conduct of the research, such as unanticipated problems, adverse events. or any problem that may increase the risk to the human subjects, notify UCRIHS promptly. Forms are available to report these issues. Please use the IRB number listed above on any forms submitted which relate to this project, or on any correspondence with UCRIHS. Good luck in your research. If we can be of further assistance, please contact us at 517-355-2180 or via email at UCRIHS@msu.edu. Thank you for your cooperation. Sincerely, W Z— Peter Vasllenko, PhD. UCRIHS Chair Ci Eric Kou 1540 Spartan Village Apt. A 83 Appendix B - Consent Form (Subjects with arthritis) Child resistant drug packaging and arthritis: Can people with arthritis access their medications? Instructions And Research Study Consent Form At present, the Consumer Products Safety Commission's Test of Child Resistant Packages that is intended to assess “user friendliness” excludes anyone with an “overt or obvious disability.” As a result. drug packages that are currently on the market can be difficult to open for a large percentage of the population. We hope to gather data about the difficulties associated with the ease of use of drug packages that are currently on the market, and generate ideas for new packages so that designs that are easier to use can be developed. If you decide to participate in this research study, you will be asked to fill out information regarding your gender, preferred dexterity, and information about your medication usage. You will be asked to answer a brief questionnaire. A digital photograph will be taken of each of your hands to determine their size and shape. Your grip strength will be measured using a dynamometer. A dynamometer is a device which you squeeze. You will squeeze this device to the greatest of your ability for 3 seconds using each hand. You will do this 3 times with right hand and 3 times with your left. Your ability to squeeze will be tested using a squeeze dynamometer. Like the grip dynamometer, you will be asked to squeeze the bulb 3 times using your right hand and three times using your right. You will also be asked to use a wrist dynamometer to measure the strength in your wrists. As with the other two instruments, you will be asked to do this three times with the right hand and three times with the left. Your visual acuity will be measured as well. You will be asked to hold a near point visual acuity card 16' from your eyes and read the lowest line on the card that you are able to decipher. After the strength of your hands has been characterized, and your visual acuity has been tested, there will be a 10 minute break period with refreshments. Following this, you will be asked to help us test a series of child resistant packages that are currently on the market. All package testing will be recorded using a Sony TRV133 digital video camera. Video clips will be used to verify recorded opening and closing times, and also may be used for presentation and teaching purposes. You will not be identified by name in any of these clips. Four groups of three packages (a total of 12) will be tested (see Table 1). To test the packages, the container will be placed on a table within your reach. You will be asked. “can you try to open this package"? Timing will commence from the moment that you pick up the package, and will end when it is successfully opened. or 70 seconds elapses. whichever occurs first. In the event that you successfully open the package. you will be given an additional 70 second period and asked to re close it. The time to re close the package will also be recorded. You may stop and move on to the next package at any time you wish; in the event that you try to open a package for 70 seconds, but can't, we will record the package as a failure and begin testing a new package. Between test groups 3 and 4, researchers will determine your “functional grip diameter.” The functional grip diameter is determined by asking you to slide your hand as far down a cone shaped measuring device as you can and still maintain tip-to-tip contact between your thumb and “pointer” finger. You will be asked to repeat this using thumb and middle finger. Both the left and right hand will be measured. You will receive a $25 Meijer gift card for each meeting that you attend. if you decide to participate, you are free to withdraw your consent and to discontinue participation at any time without penalty. To Participate you must: 0 be 60 or older 0 have at least partial use of one of your hands Page 1 of 3 84 As mentioned, package testing will be videotaped by researchers; we will also take some digital pictures. Edited versions of the taped sessions and the pictures will be used for presentations to the industry and in the classroom. These video tapes may show you in a vulnerable position if you have difficulty or struggle with any of the packages that we give to you. It is our hope that showing the difficulties associated with packaging will raise the awareness of the industry and the approach to design taken by current and future designers regarding ease of use. The ultimate goal is to affect change. In the event that you are featured in a presentation clip, you will be identified only by first name; last names will never be used in any of the records. Your privacy will be protected to the maximum extent allowable by law. Possible risks include the chance that you could injure yourself as your hand strength is being measured. or as you try to open packages. These risks include the possibility of straining the muscles of your forearm or hands. This research study will not benefit you directly. However, your participation in the study will aid our understanding of what makes packages easier or difficult to use. As mentioned. our hope is to affect change in package design. If you are injured as a result of participation in this research project. Michigan State University and Eastern or Western Michigan University will assist you in obtaining emergency care, if necessary for research related injuries. if you have insurance for medical care, your insurance carrier will be billed in the ordinary manner. As with any medical insurance, any costs that are not covered or in excess of what are paid by your insurance will be your responsibility. Financial compensation for lost wages. disability, pain or discomfort is not available. This does not mean that you are giving up any legal rights you may have. You may contact Laura Bix (517) 355-4556 with any questions. If you have any questions or comments regarding this study, please contact Dr. Laura Bix, Assistant Professor of Packaging, at 153 Packaging Building Michigan State University 48823, 517-355-4556 or bixlaura@msu.edu with any questions. In case you have question or concerns regarding your rights as a study participant, or are dissatisfied at any time with any aspects of this study, you may contact- anonymously, if you wish- Peter Vasilenko, Ph.D., Chair of the University Committee on Research Involving Human Subjects (UCRIHS) by phone: (517) 355-2180, fax: (517) 432-4503, email: ucrihs@msu.edu, or regular mail, 202 Olds Hall, East Lansing, MI 48824. Page 2 of 3 85 Table 1- Data Collection Responsible . Approximate . Step , Activrty to be performed duration of Total time elapsed p811}! activity I. OT/PKG Obtain informed, written consent 10 minutes 10 minutes 2. OT/PKG Subject infomiation I minute 11 minutes 3. OT Assessment of pain 0.5 minutes “.5 minutes 4. OT Mini Mental Stat:eisitii<:;nination (MMSE) 7 minutes 18.5 minutes 5. OT Digital photograph documenting hand size 0.5 minutes 19 minutes 6. OT Grip Dynamometer 5 minutes 24 minutes 7. OT Visual Acuity 0.5 minutes 24.5 minutes 8. OT Wrist Dynamometer 1 minute 25.5 minutes 9. OT Bulb dynamometer 1 minute 26.5 minutes 10. OT Assessment of pain 0.5 minutes 27 minutes , 11. - . Refreshment Break ' ‘ ~ 10' minutes T37 minutes 12. PKG Testing of a group of 3 packages (GROUP 1) 10 minutes 47 minutes 13. PKG Survey information 2 minutes 49 minutes [4. PKG Assessment of pain 0.5 minutes 49.5 minutes l5. PKG Testing of a group of 3 packages (GROUP 2) 10 minutes 59.5 minutes 16. PKG Rest period at table 3 minutes 62.5 minutes l7. PKG Testing of a group of 3 packages (GROUP 3) 10 minutes 72.5 minutes 18. PKG Measurement of functional grip diameter 2 minutes 74.5 minutes 19. PKG Assessment of Pain 0.5 minutes 75 minutes 20. PKG Testing of a group of 3 packages (GROUP 4) 10 minutes 85 minutes l voluntarily agree to participate in this study: Date: You will be provided with a copy of this form. Page 3 of 3 UCRIHS APPROVAL FOR THIS project EXPIRES: OCT 2 4 7006 RENEWAL mnemou MONTH TO ABOVE DATE T0 comma 86 Appendix C — Consent Form (Subjects without arthritis) Child resistant drug packaging and arthritis: Can people with arthritis access their medications? Instructions And Research Study Consent Form Laura Bix, Packaging, Michigan State University Debra Lindstrom-Hazel, Occupational Therapy, Western Michigan University Carolyn Glogloski and Michael Chan, Occupational Therapy, Eastern Michigan University You are invited to participate in a research study to see if people with and without arthritis can open their medication packages. We hope to gather data about the difficulties associated with the ease of use of drug packages that are currently on the market, and generate ideas for new packages so that designs that are easier to use can be developed. At present, the Consumer Products Safety Commission’s Test of Child Resistant Packages that is intended to assess “user friendliness" excludes anyone with an “overt or obvious disability." As a result, drug packages that are currently on the market can be difficult to open for a large percentage of the population. To Participate you must: . be 60 or older 0 have at least partial use of one of your hands a DO NOT have a diagnosis of arthritis affecting your hands if you decide to participate in this research study and are a match for age and gender with someone that has already been tested that HAS arthritis, you will be asked to fill out some general information about yourself. After that the researchers will ask you some questions to ensure that you are able to carry out the tasks required for this study. If you are not eligible to continue the study (after you have been matched for age and gender), you will be thanked for your time and given a $25 Meijer gift certificate. A detailed list of the procedures is included on page 4 of this form. Research study activities include taking a digital photograph of each of your hands, measuring your grip strength and functional grip in both hands and asking you to read small print on a card. Part way through the activities there will be a 10-minute break period with refreshments when we will talk to you about your experiences with managing your medications. Throughout the procedure we will ask you to rate your level of pain with the tasks. You are free to withdraw from the study at any time for any reason. If the occupational therapy researchers feel that you are in too much pain to continue with the study, we will thank you for your time and Pace 1 of 5 This consent form was approved by the Social Science/Behavioral/Education Institutional Review Board (SlRB) at Michigan State University. Approved 7/18/06 - valid through 10/24/06. This version supersedes all previous versions. [RB # 05-819 87 discontinue your participation in the study. You will still receive the $25 Meijer gift certificate. Following the refreshment break, you will be asked to help us test a series of child resistant packages that are currently on the market. All package testing will be recorded using a Sony TRV133 digital video camera. Video clips will be used to verify opening and closing times. We are also asking you for permission to use these video clips for presentation and teaching purposes in the future. These video tapes may show you in a vulnerable position if you have difficulty or struggle with any of the packages that we give to you. At the end of this form you will have the opportunity to either grant or decline permission to use the video clips and digital photos for any purposes beyond the research. You will not be identified by name in any of these clips, whether or not they are used for research or educational/presentation purposes. Data collected will not be tracked by name, only by subject number. Your privacy will be protected to the maximum extent allowable by law. You will receive a $25 Meijer gift certificate in exchange for your participation. If you decide to participate, you are free to withdraw your consent and to discontinue participation at any time for any reason without penalty. If you withdraw, you will still keep the gift card. You will not directly benefit from your participation in this study. but your participation may contribute to our understanding of the difficulties associated with packaging, raise the awareness of the industry, and change the approach to design taken by current and future designers. The ultimate goal is to affect change. Possible risks include the chance that you could injure yourself as your hand strength is being measured, or as you try to open packages. These risks include the possibility of straining the muscles of your forearm or hands, muscle or joint soreness and the loss of the time it takes to conduct the research study. If you are injured as a result of your participation in this research project, researchers from Michigan State University, Eastern Michigan University or Western University will assist you in obtaining emergency care, if necessary, for your research related injuries. If you have insurance for medical care, your insurance carrier will be billed in the ordinary manner. As with any medical insurance, any costs that are not covered or in excess of what are paid by your insurance, including deductibles, will be your responsibility. The University’s policy is not to provide Page 2 of 5 This consent form was approved by the Social Science/BehavioraVEducation Institutional Review Board (SIRB) at Michigan State University. Approved 7/18/06 - valid through 10/24/06. This version supersedes all previous versions. IRB # 05-819 88 financial compensation for lost wages, disability, pain or discomfort unless required by law to do so. This does not mean that you are giving up any legal rights you may have. You may contact Laura Bix at 517-355-4556 or Debra Lindstrom-Hazel at 269-387-7239 with any questions or to report an injury. If you have any questions or comments regarding this study, please contact Dr. Laura Bix, Assistant Professor of Packaging, at 153 Packaging Building Michigan State University 48823, 517-355-4556 or bixlaura@msu.edu or Debra Lindstrom- Hazel, Associate Professor of Occupational Therapy, Western Michigan University, at 269-387-7239 or debra.hazel@wmich.edu. In case you have question or concerns regarding your rights as a study participant, or are dissatisfied at any time with any aspects of this study, you may contact- anonymously, if you wish- Peter Vasllenko, Ph.D.,Director of Human Research Protections, (517) 432-4503, email irb@msu.edu, mail 202 Olds Hall, Michigan State University, East Lansing, MI 48824-1047. You may also contact the Human Subjects Institutional Review Board of Western Michigan University at 269-387- 8293 or the Vice President for Research’s Office at WMU 259-387-8298. Page 3 of 5 This consent form was approved by the Social Science/Behavioral/Education Institutional Review Board (SIRB) at Michigan State University. Approved 7/18/06 - valid through lO/24/06. This version supersedes all previous versions. IRB # 05-8l9 89 Table 1- Data Collection . Approximate . Step Responsible Activity to be performed duration of Toltal he": party activity e aps 1. OT/PKG Obtain informed written 7 minutes 7 minutes - consent 2. OT/PKG Subject information 1 minute 8 minutes 3. OT Assessment of pain 0.5 minutes 8.5 minutes Mini Mental State Examination . . 4. . OT (MMSE) testing 8 minutes 16.5 minutes 5. OT 2 D'g'tal photograph documenting 0.5 minutes 17 minutes - hand Size 6. OT 3 . Grip Dynamometer 4 minutes 21 minutes 7. OT Visual Acuity H1 minutes 22 minutes 8. 3 OT Wrist Dynamometer 1 minute 23 minutes__ 9. l OT Bulb dynamometer 1 minute 24 minutes 10. OT Assessment of pain 0.5 minutes 24.5 minutes 11. Refreshment Break / Survey information 10 minutes 34.5 minutes Testing of a group of 5 . . 12. PKG packages (GROUP 1) 10 minutes 44.5m1nutes 13. PKG Rest period at table 3 minutes 47.5 minutes 14. PKG ; Measurement Of functional grip 2 minutes 49.5 minutes ; diameter 15. PKG ? Assessment of Pain 0.5 minutes 50 minutes Testing of a group of 5 . . 16. PKG packages (GROUP 2) 10 minutes 60 minutes I voluntarily agree to participate in this study: Date: Page 4 of 5 This consent form was approved by the Social Science/Behavioral/Education Institutional Review Board (SIRB) at Michigan State University. Approved 7/18/06 - valid through 10/24/06. This version supersedes all previous versions. IRB # 05-819 90 l: l consent to having my videotaped session or digital photos of my hands used for teaching and presentation purposes. (You will not be identified by name in any of these presentations). I do NOT consent to having my video taped session used for teaching or presentation purposes. (In this case the video taped session will only be used to accurately determine the time required to open each of the packages). You will be provided with a copy of this form. ‘ Page 5 of 5 | This consent form was approved by the Social Science/Behavioral/Education Institutional Review Board (SIRB) at Michigan State University. Approved 7/l8/06 - valid through lO/24/06. This version supersedes all previous versions. IRB # 05-819 91 Appendix D - Recruitment F lyer Opportunity for people 60 and older to participate in a research project regarding the difficulties associated with child resistant drug packaging This research project is a joint study between the MSU School of Packaging and the WMU Department of Occupational Therapy. The study will examine the difficulties associated with child resistant drug packaging when it is used by people age 60 and older. Testing will take place at various locations including: WMU Unified Clinics: 1000 Oakland Drive Kalamazoo, MI 49008 River Manor Senior Housing, 1000 Shadow Lane Galesburg, MI Friendship Village, 1400 N Drake Rd Kalamazoo, MI 49006 Dillon Hall, 3299 Gull Road Kalamazoo, MI 49048 And Senior Centers: Portage Senior Center, 320 Library Lane Portage, MI 49002 Kalamazoo Senior Center, 1981 Jasper St. Kalamazoo, MI 49001 The Marquette 5928 Park Lake Road, Okemos, Ml Abbott Parkside Senior Apartments, East Lansing, MI And Dr. Carla Guggenheim’s Office, Lansing, MI And The School of Packaging at Michigan State University Testing will take no longer than 1.0 hours; during testing the researchers will measure the strength and size of your hands, you will be asked to fill out a brief survey regarding your use of medications and you will be asked to open and close several 92 different child resistant drug packages. Much of the testing will be videotaped. In exchange for your participation, you will be provided with a $25 Meijer gift certificate. If at any time you are uncomfortable with the testing or wish to discontinue the data collection process, you may discontinue participation without penalty. If you are interested in learning more about this study, please contact Eric Kou at koueric@msu.edu or phone (517) 355-8203 to make an appointment. If you have questions or comments regarding this study, please contact Dr. Laura Bix, at Michigan State University at (517) 355-4556 or bixlaura@msu.edu or Dr. Debra Lindstrom- Hazel at Western Michigan University at debra.hazel@wmich.edu. If you have questions or concerns about your rights as a study participant contact the WMU HSIRB at (269) 387-8293. 93 Appendix E - Data Collection Sheet Subject # Female Male Age Diagnosis (circle) Rheumatoid Arthritis with hand involvement Osteoarthritis with hand involvement No diagnosis of arthritis of the hands Duration of disease Duration of Arthritis Impacting hand Do you have use of at least one hand? Do you wear eye wear for reading purposes? Subject should review consent form Are you left or right handed? (circle) Right hand Left hand Pain scalc reading #1 Level of Education 0-4 years 5-8 years 9-12 years 212 years MMSE 94 Digital Photo of Left hand (file number) Digital Photo of Right hand (file number) Trial 1 Trial 2 Trial 3 Do you wish to discontinue participation because of pain? Visual Acuity Wrist Dynamometer (only test subjects in the counterclockwise direction) Right (hold base with left Left (hold base with hand) right hand) Trial 1 Trial 2 Trial 3 Do you wish to discontinue participation because ofpain? Palm Stren Bulb meter Ri t Trial 1 Trial 2 Trial 3 Do you wish to discontinue participation because ofpain‘? Pain scale reading #2 Is it OK if we ask you a few questions while you eat? ------------ 10 Minute Refreshment Break----—-------- On a scale of 1-10 (show the subject the scale) How satisfied are you with your ability to manage your own medications? l 2 3 4 5 6 7 8 9 10 95 How satisfied are you with your ability to open the child resistant packages for medications? 1 2 3 4 5 6 7 8 9 10 How important do you think it is to manage your own medications? 1 2 3 4 5 6 7 8 9 10 How well do you think that you perform when managing your own medications? 1 2 3 4 5 6 7 8 9 10 How many medications do you take daily? Do you open your own mediation? If not, who opens it for you? Are you aware that you can ask the pharmacist for packages that do not have child resistant closures? Are you aware that you can purchase medication over the counter that don’t have child resistant closures? Do you wish to discontinue participation because of pain? Pain scale reading #3 Packa testin Gro 1 Opened? Abort? (Time) Time to open Time to close Yes/No Rest Period at Test Table (3 minutes) 96 testin 2 Abort? (Time) Time to open Functional grip diameter right hand Functional grip diameter left hand Thank the subject. Have them print and sign that they have received the Meij er card. X 97 Time to close Appendix F - Package Dimensions ‘— 38.43mm "‘ Closure: 20—400 SSC (CT); PP Bottle: 2.0002 PP Boston Round Natural 1, Closure: 45400 FG (P&T); PP Bottle: 200.00 CC HDPE Square Wide Mouth Packer White 98 Closure: 24m LP SQ-LK (sL); pi» Bottle: 1 oz HDPE Square Bottle (24MM CR) White . , Closure: 24—400 HSC (er); PP Bottle: 2.00 oz PP Boston Round Natural 99 38.43mm "’ Closure: 20—400 FG (P&T); PP Bottle: 2.00 oz PP Boston Round Natural Closure: 45400 isc (er), PP Bottle: 200.00CC HDPE Square Wide Mouth Packer White 100 Closure: 28—400 FG (P&T); PP Bottle: 45 00 CC HDPE Square Wide Mouth Packer White F Closure: 38mm LP sQ-LK (SL); PP Bottle: 4 oz HDPE Square Bottle (38MM CR) White newsman-:3 .-:-.-«-m~..=.«;» - - -. n; . . , ., 101 Closure: 2'8-400 Lsctcr); PP Bottle: 45.00 CC HDPE Square Wide Mouth Packer White , Closure: 24-400 FG(P&T); PP ; Bottle: 2.0002 PP Boston Round Natural 102 Appendix G - Raw Data Table 36 — Raw data Duration of Use of Sub'ect . . ' E e Dominant Level of 1: Gender Age Diagnosrs 12:22:11; atalter:St wzar hand Education Hand band 001 Female 88 CA 15/15 Y Y R 12 or > 002 Female 87 0A 3 / 2 Y Y R 12 or > 003 Female 82 0A 21 / 16 Y Y R 12 or > 004 Male 80 RA 25 / 20 Y Y R 12 or > 005 Female 86 RA 30 / 30 Y Y R 12 or > 006 Female 76 Both 40 / 40 Y Y R 12 or > 007 Female 85 RA 5 / 3 Y Y R 12 or > 008 Female 84 DA 40 / 40 Y Y R 12 or > 009 Female 93 0A 30 / 2 Y Y R 12 or > 010 Female 65 Both 35 / 3 Y N R 12 or > 011 Female 68 RA 10/10 Y Y R 12 or> 012 Female 71 N - Y Y L 12 or> 013 Female 77 CA 15/10 Y Y R 12 or> 014 Female 84 N - Y Y R 12 or > 015 Female 88 0A 50 / 50 Y Y A 12 or > 016 Female 87 0A 8 / 8 Y Y R 12 or > 017 Female 79 N - Y Y R 12 or > 018 Female 7 0A 44 / 44 Y Y L 9 - 12 019 Female 74 RA 30 / 20 Y Y R 12 or > 020 Male 75 0A 10 / 6 mos Y Y R 12 or > 021 Female 72 N - Y Y R 12 or > 022 Female 82 N - Y Y R 12 or > 023 Male 83 N - Y Y R 12 or > 024 Female 86 N - Y Y R 12 or > 025 Female 81 RA 35 / 25 Y Y L 9 - 12 026 Female 77 RA 25 / 25 Y Y R 12 or > 027 Female 76 Both 20 / 7 Y Y R 12 or > 028 Female 81 0A 10/ 10 Y Y R 12 or > 029 Female 91 DA 5 / 1 Y Y R 12 or > 030 Female 85 0A 20 / 5 Y Y R 9 - 12 031 Female 85 CA 30 / 20 Y Y R 12 or > 032 Female 70 Both 4 / 4 Y Y R 9 - 12 033 Female 72 0A 9 / 1 Y Y R 12 or > 034 Female 79 Both 20 / 20 Y Y R 9 — 12 035 Female 80 N - Y Y R 5 - 8 036 Female 70 RA 38 / 26 Y Y R 12 or > 037 Female 64 0A 5 / S Y N R 12 or > 038 Female 60 CA 20 / 20 Y Y R 12 or > 039 Female 69 OA 15 / 15 Y Y R 12 or > 040 Female 80 OA 1 / 1 Y Y R 12 or > OA — Osteoarthritis, RA — Rheumatoid Arthritis, N — No/None, Y — Yes, R — Right, L - Left, A — Ambidextrous, Gray — Data Excluded (No match, Pain or MMSE) 103 Table 36 -- Raw data (cont’d) Duration of Use of Sub'ect . . Disease / at l E e Dominant Level of 1: Gender Age Dmgnosrs Impacting 0:2“ Wzar hand Education Hand band 041 Female 70 Unsure 65 / 65 Y Y R 9 - 12 042 Female 78 Unsure 5 / 1 Y Y R 12 or > 043 Female 78 N - Y Y R 12 or > 044 Female 72 0A 30 / 20 Y Y R 12 or > 045 Female 73 CA 30 / 30 Y Y R 9 - 12 046 Male 80 N - Y Y R 12 or > 047 Female 74 CA 25 / 4 Y N R 12 or > 048 Female 71 CA 15 /1 Y Y R 12 or > 049 Female 65 0A 5 / 3 Y Y L 12 or > 050 Female 81 RA 15/15 Y Y R 9 - 12 051 Female 94 N - Y Y R 9 - 12 052 Female 92 N - Y Y R 12 or > 053 Female 84 RA 3 / 6 mos Y Y R 5 - 8 054 Female 74 RA 10/ 10 Y Y R 12 or > 055 Male 75 N - Y Y R 12 or > 056 Female 78 Unsure 4 / 3 Y Y R 12 or > 057 Female 64 Unsure 5 / 5 Y Y R 12 or > 058 Female 97 0A 33 / 10 Y Y R 5 - 8 059 Female 75 Unsure 10/ 10 Y Y R 12 or > 060 Female 65 RA 7 / 5 Y Y R 12 or > 061 Female 84 Unsure 2 / 8 mos Y N R 5 - 8 062 Male 88 N - Y N R 5 - 8 063 Male 87 Unsure 1 / 1 Y Y L x 064 Female 89 N - Y Y R 9 - 12 065 Female 71 N — Y Y R 9 - 12 066 Female 85 N - Y N R 9 - 12 067 Female 82 N - Y Y R 12 or > 068 Female 87 N - Y Y R 12 or > 069 Female 85 N - Y Y R 12 or > 070 Female 77 N - Y Y R 12 or > 071 Female 75 N - Y Y R 9 - 12 072 Female 73 N - Y Y R 9 - 12 073 Female 79 N - Y Y R 9 - 12 074 Female 69 N - Y Y R 12 or > 075 Female 81 N - Y Y R 12 or > 076 Female 89 N - Y Y R 12 or > 077 Female 70 N - Y Y R 12 or > 078 Male 71 RA 2 / 2 Y Y R 12 or > 079 Female 79 N - Y Y R 12 or > 080 Female 71 N - Y Y R 12 or > OA — Osteoarthritis, RA — Rheumatoid Arthritis, N — No/None, Y — Yes, R — Right, L — Lefi, A - Ambidextrous, Gray — Data Excluded (No match, Pain or MMSE) 104 Table 36 - Raw data (cont’d) Duration of Use of Subject Gender Age Diagnosis Disease / at least Eye Dominant Level pf # Impacting one Wear hand Education Hand band 081 Female 82 Both 10 / 10 Y Y R 12 or > 082 Female 63 Both 30/ 10 Y Y R 12 or > 083 Male 70 N - Y Y R 12 or > 084 Female 68 N - Y Y R 12 or > 085 Male 68 Unsure 10/ 10 Y Y R 12 or > 086 Male 71 Unsure 20 / 20 Y Y R 12 or > 087 Female 65 0A 5 / 7 Y Y R 12 or > 088 Female 74 OA ,15/ 15 Y Y R 12 or > 089 Female 78 N - Y Y R 12 or > 090 Female 86 N - Y N R 12 or > 091 Female 60 N - Y Y R 12 or > 092 Female 64 N - Y Y R 12 or > 093 Female 72 N - Y Y R 12 or > 094 Female 81 N - Y N L 9 — 12 095 Female 68 N - Y Y R 9 - 12 096 Female 76 N - Y Y R 12 or > 097 Male 79 N - Y Y L 12 or > 098 Male 69 N - Y Y R 12 or > 099 Female 61 N - Y Y R 12 or > 100 Female 82 N - Y N R 9 - 12 101 Female 74 N — Y Y R 9 - 12 102 Female 84 N - Y Y R 9 - 12 103 Female 77 N - Y Y R 9 - 12 104 Female 85 N - Y Y R 12 or > 105 Male 71 N - Y Y L 12 or > 106 Female 85 N - Y Y R 12 or > 107 Female 66 N - Y Y R 12 or > 108 Female 65 N - Y Y R 12 or > 109 Female 64 N - Y Y R 12 or > 110 Female 74 N - Y Y R 12 or> OA — Osteoarthritis, RA — Rheumatoid Arthritis, N - No/None, Y — Yes, R — Right, L — Left, A — Ambidextrous, Gray —— Data Excluded (No match, Pain or MMSE) 105 Table 36 - Raw data (cont'd) Gri Dynamometer (lbs) Subject MMSE DigitatPhoto of Left R L R L R L Visual # / Right Hand 1 1 2 2 3 3 Acuity 001 30 001/002 l4 16 14 l6 14 16 20/30 002 29 003 / 004 20 20 20 22 22 22 20/40 003 28 005 / 006 16 l6 16 16 l6 18 20/50 004 29 007 / 008 12 12 14 14 14 14 20/30 005 29 009 / 010 22 15 l6 14 19 16 20/20 006 28 011/012 9 9 13 9 13 9 20/50 007 28 013 / 014 26 26 26 22 26 26 20/100 008 30 015 /016 22 22 22 22 22 26 20/50 009 28 017 / 018 40 31 44 35 48 35 20/100 010 30 019 / 020 12 18 22 22 18 26 20/30 011 29 021 /022 22 26 33 35 37 37 20/50 012 30 023 / 024 26 20 26 24 26 26 20/20 013 29 025 / 026 l6 16 16 16 15 16 20/30 014 30 027 / 028 14 8 l6 7 16 7 20/30 015 29 029 / 030 15 14 16 15 15 16 20/30 016 30 031 /032 22 16 20 18 21 18 20/50 017 23 033/034 40 31 35 35 31 31 20/150 018 29 035 / 036 26 31 22 22 22 22 20/80 019 29 037/ 038 20 15 20 20 20 20 20/80 020 29 039/ 040 75 75 80 70 80 70 20/50 021 30 041 / 042 (left hands) x 55 x 45 x 55 20/40 022 25 043 / 044 25 35 30 30 25 35 20/80 023 29 045 / 046 70 90 80 90 70 95 20/30 024 29 047/ 048 40 35 40 40 35 40 20/20 025 29 049/ 050 35 25 35 30 30 25 20/40 026 28 051 /052 9 13 13 13 13 4 20/40 027 29 053 / 054 22 22 22 22 22 22 20/50 028 28 055 /056 40 31 31 31 31 31 20/100 029 26 057 / 058 35 22 35 22 31 10 20/40 030 30 059 / 060 31 31 31 35 50 14 20/100 031 29 061 / 062 35 35 44 40 44 44 20/80 032 29 063 / 064 26 22 22 22 18 10 20/50 033 27 065 / 066 49 53 44 44 44 49 20/40 034 29 067/ 068 26 22 26 22 26 18 20/80 035 30 069/ 070 49 49 53 49 49 49 20/80 036 24 071 / 072 53 49 44 49 40 44 20/ 100 037 29 073 / 074 70 60 65 50 70 60 20/40 038 27 075 / 076 60 65 60 65 55 65 20/20 039 24 077/ 078 65 50 60 50 60 45 20/30 040 26 079/ 080 35 50 40 45 40 45 20/40 R - Right, L — Left, Gray — Data Excluded (No match, Pain or MMSE) 106 Table 36 - Raw data (cont'd) Subject MMSE DigitaIOPhoto of R LG" Dram?” (“1’3 L Visual # Left / Right Hand 1 l 2 2 3 3 Acuity 041 29 081 /082 18 13 13 13 13 9 20/50 042 25 083 / 084 26 26 31 26 35 22 x 043 30 085 / 086 44 49 53 53 62 57 20/30 044 30 087 / 088 49 40 49 40 44 40 20/40 045 30 089 / 090 40 26 26 26 31 26 20/40 046 30 091 /092 88 88 93 88 93 88 20/40 047 29 093 / 094 31 44 49 44 4O 40 20/50 048 30 095 / 096 40 35 40 31 35 31 20/30 049 29 097 / 098 18 18 26 35 44 40 20/30 050 29 099/ 100 40 40 35 40 31 44 20/50 051 24 101 / 102 35 31 40 35 44 40 x 052 29 103/104 31 31 35 31 31 31 20/100 053 24 105/ 106 18 18 9 26 9 26 20/150 054 30 107/ 108 53 35 57 49 57 44 20/100 055 30 109/ 110 88 53 66 53 57 57 20/80 056 25 111 / 112 31 26 35 26 35 35 20/150 057 29 113 / 114 57 26 44 26 49 22 20/40 058 26 115/ 116 26 35 26 36 31 35 20/50 059 26 117/ 118 40 31 31 26 26 26 20/40 060 27 119/ 120 35 18 13 18 13 18 20/80 061 22 122/121 22 18 22 18 22 22 x 062 26 123/ 124 44 31 40 35 31 35 20/60 063 x 125 / 126 (No Pic) x x x x x x x 064 30 127/ 128 45 45 45 40 40 45 20/60 065 30 129/ 130 35 35 40 30 40 35 20/40 066 25 131 / 132 45 50 45 45 45 50 20/200 067 27 133/ 134 35 44 40 44 40 49 20/100 068 28 135 / 136 44 40 44 44 44 40 20/50 069 29 137/ 138 44 35 49 44 49 44 20/60 070 28 139/ 140 40 57 44 62 40 31 20/50 071 20 141 / 142 (No Pic) x x x x x x x 072 29 143/ 144 50 50 50 55 45 55 20/80 073 26 145/ 146 40 30 40 30 35 30 20/40 074 28 147/ 148 66 53 62 49 57 57 20/50 075 28 149/ 150 35 40 40 35 35 40 20/50 076 26 151 / 152 44 49 44 57 53 44 20/50 077 30 153/ 154 26 40 31 35 40 40 20/40 078 28 155 / 156 31 53 31 53 49 60 20/20 079 28 157/ 158 66 62 71 57 66 57 20/30 080 29 159/ 160 49 44 49 44 49 49 20/40 R —- Right, L — Left, Gray -— Data Excluded (No match, Pain or MMSE) 107 Table 36 - Raw data (cont'd) Subject MMSE Digital-Photo or Left R LG" ”gnaw?” 0:) L Visual # / Right Hand 1 1 2 2 3 3 Acuity 081 29 161 7162 35 4o 35 40 35 40 20730 082 28 ’ 163/164 60 60 55 50 55 50 20740 083 27 165 7 166 75 75 80 75 75 80 20720 084 26 167 7 168 45 50 55 55 55 50 20730 085 28 169/ 170 26 22 22 28 22 32 20/60 086 24 171 7172 57 75 66 75 71 79 20750 087 30 173 / 174 57 53 57 53 57 53 20730 088 28 175 7 176 35 26 31 26 31 26 20750 089 27 1777 178 53 44 40 40 4o 40 20750 090 27 179/ 180 40 35 35 31 31 31 x 091 27 181/182 18 9 13 9 13 9 207100 092 29 183/ 184 31 31 18 26 22 18 207100 093 26 185/ 186 22 26 26 26 31 31 207100 094 25 187/ 188 53 44 57 57 53 49 20750 095 28 189 7 190 40 44 31 49 31 44 20750 096 30 191 7192 44 40 49 40 49 44 20750 097 28 1937 194 75 75 84 79 88 79 20750 098 30 1957 196 53 66 53 62 53 62 20740 099 29 197 7 198 66 57 62 57 57 53 20/80 100 28 199 7 200 40 40 49 44 44 35 20750 101 29 201 7202 40 4o 40 40 40 40 20740 102 28 203 7 204 40 35 49 35 4o 35 x 103 29 205 7 206 40 40 40 40 35 35 20750 104 27 207 7 208 53 49 53 57 49 62 20750 105 28 209 7 210 71 71 75 84 79 79 207100 106 27 211 7212 35 35 40 40 40 35 x 107 29 213 7 214 71 49 57 62 66 49 20750 108 30 215 7 216 50 50 6O 60 65 60 20740 109 29 217 7 218 55 50 50 55 50 45 20720 110 30 219 7 220 45 45 55 45 60 45 20750 R — Right, L — Left, Gray —- Data Excluded (No match, Pain or MMSE) 108 Table 36 - Raw data (cont'd) Bulb Dynamometer - Palm Strength . Wrist Dynamometer — Counterclockwise (lbs) (psi) 5mm“ # R L R L R L R or L R or L R or L 1 1 2 2 3 3 l 2 3 001 80 70 80 60 70 80 2.5 2 2.5 002 120 120 150 120 150 120 4 4 3 003 70 70 80 60 8O 7O 2 2.5 2.5 004 50 70 60 60 50 70 4.5 4.6 5 005 50 50 60 60 55 60 2.5 2 2 006 20 20 10 20 25 30 0 0 0 007 40 50 50 40 70 40 0 0 0 008 90 80 120 120 130 150 3 2 3 009 60 60 70 40 60 50 2 2 1 010 20 30 20 30 20 40 2 2 2 01 l 35 20 3O 20 55 25 2 4 3.5 012 140 145 145 170 160 170 5.5 5 5 013 20 50 20 60 35 60 2 1 1 014 65 20 6O 20 60 25 0.5 1.5 2 015 85 100 80 95 55 90 1 3 2 016 100 95 100 105 100 110 3.5 3 3.5 017 30 20 20 30 20 20 2 1 1 018 50 40 4O 40 30 50 2 1 1 019 100 80 80 80 85 105 9 10 9 020 180 165 220 170 200 170 10 10 15 021 x 95 x 90 x 90 x x x 022 85 70 80 80 90 80 2.5 3.5 5 023 210 190 260 210 260 J 250 8 8.5 8 024 55 70 80 50 75 80 1 3 2 025 80 80 80 80 90 70 0.5 1 4 026 10 10 10 10 10 10 O 0 0 027 60 50 60 50 60 50 1 2 2 028 50 50 50 50 40 40 2 1 1 029 80 60 100 70 1 10 90 4 4 3 030 60 50 7O 6O 70 50 1 2 2 031 60 50 100 70 1 10 90 3 5 4 032 30 30 40 40 30 50 2 1 1 033 110 140 140 120 150 120 4 5 4 034 20 10 20 20 20 20 3 2 3 035 40 50 60 60 60 60 5 5 4 036 0 40 10 30 10 20 3 3 3 037 70 70 80 80 90 70 12 12 14.5 03 8 70 90 70 100 70 90 7 7 8.5 039 50 60 80 60 50 30 5 8.5 8 040 20 40 30 ' 4O 40 4O 3 3 2.5 109 R - Right, L — Left, Gray — Data Excluded (No match, Pain or MMSE) Table 36 - Raw data (cont'd) Bulb Dynamometer - Palm . Wrist Dynamometer - Counterclockwise film Strength @811 sum“ # R L R L R L R or L R or L R or L 1 1 2 2 3 3 l 2 3 041 0 0 0 0 O 0 1 1 1 042 10 10 20 0 10 0 l 1 1 043 60 7O 90 7O 9O 70 5 5 5 044 50 40 4O 30 50 50 3 4 4 045 0 O 0 0 O 0 2 2 2 046 100 130 130 160 130 160 14 15 8 047 40 40 50 50 6O 50 5 6 4 048 20 30 30 4O 30 40 2 2 2 049 20 0 40 10 O O 3 4 4 050 70 80 80 100 80 120 2 2 3 051 40 20 50 20 50 20 1 3 4 052 0 0 0 0 O 0 0 1 1 053 0 O O O 0 0 0 2 1 054 70 50 7O 60 80 70 4 4 2 055 120 60 130 80 120 70 9 6 9 056 10 10 10 3O 10 10 2 3 2 057 50 10 60 10 60 10 6 6 5 058 0 0 10 10 10 10 1 3 4 059 10 0 O O 0 O 1 1 3 060 10 0 0 0 0 0 1 1 l 061 10 O 10 10 0 0 1 2 2 062 0 10 10 50 10 50 1 1 2 063 x x x x x x x x x 064 40 4O 7O 60 70 50 3 3 3.5 065 45 90 50 90 50 100 4 5.5 7 066 90 70 9O 50 80 60 4.5 10 6 067 30 60 60 30 50 50 4 2 3 068 60 60 70 6O 70 60 3 2 3 069 30 3O 40 40 50 40 5 6 6 070 40 70 60 70 60 9O 4 3 3 071 x x x x x x x x x 072 50 70 40 50 50 70 6 4 3 073 55 55 70 6O 70 70 4.5 4 6 074 80 60 100 60 100 80 3 3 3 075 60 80 70 70 60 70 4 2 3 076 40 50 70 60 8O 70 1 2 2 077 30 60 30 60 30 6O 1 2 2 078 20 100 80 80 80 120 2 3 3 079 90 90 100 90 80 100 5 6 5 080 50 90 100 150 130 130 6 5 7 R — Right, L — Left, Gray — Data Excluded (No match, Pain or MMSE) 110 Table 36 - Raw data (cont'd) Bulb Dynamometer - Palm . Wrist Dynamometer - Counterclockwiseflbs) Strength Jpsi) sub’ect # R L R L R L R R R 1 1 2 2 3 3 1 2 3 081 40 4o 50 50 70 6o 3 2 1 082 90 100 70 80 90 90 5 3.5 5 083 90 90 100 100 100 100 6 6 6 084 70 40 60 60 70 6o 5 5 5.5 085 40 130 50 160 70 150 8 9 10 086 80 130 80 130 90 130 7 7 6 087 60 80 70 70 60 9o 4 6 4 088 o o 0 o o 0 1 1 1 089 20 30 20 40 30 20 3 4 3 090 70 60 6O 50 50 50 3 3 4 091 0 0 o 0 0 0 5 4 6 092 40 70 40 60 20 50 2 2 1 093 30 20 40 20 50 4o 3 3 3 094 90 60 90 70 90 80 5 6 5 095 30 50 40 30 40 50 4 3 4 096 60 40 40 50 60 50 5 5 4 097 160 130 140 140 140 120 11 15 16 098 10 70 3o 60 30 60 3 4 6 099 80 60 80 60 7o 70 6 6 6 100 70 30 70 50 70 50 4 4 4 101 50 80 70 80 70 90 3 6 3 102 60 4o 60 50 70 70 4 3 3 103 40 60 50 50 6o 50 1 2 2 104 100 80 100 100 110 90 7 8 4 105 90 110 120 110 130 130 8 9 9 106 10 10 10 10 10 20 2 1 1 107 70 100 110 140 90 130 4 3 4 108 70 80 90 90 100 70 3.5 4 4 109 50 70 4o 50 40 40 3 3 3.5 110 90 8o 90 80 60 60 4 5 4 R —- Right, L — Left, Gray — Data Excluded (No match, Pain or MMSE) 111 Table 36 - Raw data (cont'd) . Satisfaction - 7 . . Importance - Performance - Subject Satisfaction - open # manage own CR packages manage pwn manage pwn medications medications medications 001 5 5 10 9 002 10 7 10 10 003 10 10 10 10 004 10 ' 8 10 9 005 9 8 10 7 006 8 1 9 8 007 10 7 9 9 008 10 3 10 9 009 4 6 1 5 010 10 10 10 8 01 1 10 2 10 9 012 10 7 10 9 013 7 5 10 10 014 1 1 10 2 015 10 10 10 10 016 10 8 10 9 017 10 6 8 1 018 10 6 10 10 019 10 1 10 9 020 10 10 10 10 021 8 1 10 8 022 10 1 10 10 023 10 l 9 10 024 7 3 9 7 025 9 2 9 9 026 8 3 10 8 027 10 7 10 10 028 9 7 10 9 029 10 8 10 10 030 10 3 10 10 031 10 10 10 10 032 6 1 10 8 033 10 4 10 10 034 7 1 10 10 035 10 10 10 10 036 3 1 10 4 037 10 7 10 10 038 10 1 10 10 039 10 8 10 10 040 3 5 5 7 Gray — Data Excluded (No match, Pain or MMSE) 112 Table 36 - Raw data Satisfaction - Satisfaction - open Importance - Performance - manage own child resistant manage own manage own medications packages medications medications Subject # 10 — Data Excluded or MMSE) 113 Table 36 - Raw data (cont'd) . Satisfaction - Satisfaction - open Importance - Performance - Subject . . # manage own child reSistant manage own manage own medications packages medications medications 081 9 5 10 9 082 10 10 10 10 083 7 5 10 8 084 10 ‘ 6 10 10 085 10 10 10 10 086 10 10 10 10 087 9 6 10 10 088 5 5 10 10 089 10 8 10 10 090 1 3 1 10 091 10 1 10 9 092 8 1 10 9 093 8 4 10 8 094 10 9 10 9 095 10 10 10 10 096 10 10 10 10 097 7 4 10 7 098 10 7 10 6 099 10 8 10 9 100 10 10 10 10 101 10 10 10 10 102 8 3 9 9 103 10 6 10 9 104 10 10 10 10 105 10 x x x 106 10 8 10 10 107 10 8 10 10 108 10 8 10 10 109 8 2 9 7 110 10 10 10 10 Gray — Data Excluded (No match, Pain or MMSE) 114 Table 36 - Raw data Subject # of medications 0 en own medications Aware Non CR-closures for # daily p Prescription / OTC 2 o / / / / / / / / / / \\\\\\\\ Gray — Data Excluded (No match, Pain or MMSE) 115 Table 36 - Raw data Subject # of medications Aware Non CR—closures for # daily Open own medications Prescription / OTC 4 Gray — Data Excluded (No match, or MMSE) 116 Table 36 - Raw data (cont'd) Subject # of medications 0 d' t' Aware Non CR-closures for # daily pen own me man ions Prescription / OTC 081 13 Yes Yes / No 082 8 Yes Yes / No 083 7 Yes No / No 084 7 Yes Yes / Yes 085 14 Yes Yes / No 086 5 Yes Yes / Yes 087 4 Yes Yes / Yes 088 9 Yes No / No 089 2 Yes No / No 090 8 No, Nurse No / No 091 6 Yes No / No 092 12 Yes No / No 093 8 Yes No / No 094 1 Yes No / No 095 17 Yes Yes / No 096 7 Yes Yes / No 097 13 Yes Yes / Yes 098 0 Yes No / No 099 4 Yes Yes / Yes 100 4 Yes Yes / Yes 101 2 Yes No / No 102 3 No, Family members Yes / No 103 9 Yes Yes / Yes 104 1 Yes No / No 105 0 Yes No / No 106 9 Yes No / Yes 107 4 Yes Yes / Yes 108 4 Yes No / No 109 1 Yes No / No l 10 3 Yes Yes / No Gray — Data Excluded (No match, Pain or MMSE) 117 Table 36 - Raw data (cont'd) Subject Package Testtni # 1 Type Opened Abort Time (s) Time to open (8) Time to close (8) 001 20mm PT No Past 70s — - 002 20mm CT Yes - 4.19 3.38 003 24mm PT No 31.69 - - 004 24mm CT Yes - 4.66 2 005 24mm SL Yes - 70 6:6 006 28mm PT No 24.5 - - 007 20mm CT No 20.34 - - 008 45mm PT No Past 70s - - 009 24mm SL No 14.5 - «- 010 24mm CT Yes - 4.47 4.65 011 20mm PT Yes - 35.81 5 012 45mm CT Yes - 3.32 3.56 013 28mm PT No 57.67 - - 014 38mm SL No Past 70s - - 015 28mm CT Yes - 4.85 3 016 24mm PT Yes - 35.69 4.87 017 20mm CT Yes - 7.28 3 018 45mm PT Yes - 11.25 6.3 019 24mm SL Yes - 31.69 5.69 020 24mm CT Yes - 6.37 2.06 021 20mm PT No Past 70s - - 022 45mm CT Yes - 1.62 2.71 023 28mm PT Yes - 6.97 4.03 024 38mm SL No 68.58 - - 025 28mm PT Yes - 26.13 4.56 026 24mm PT No 23.32 - - 027 20mm CT No 13.51 - - 028 45mm PT Yes - 25.44 Past .7087“ g 029 24mm SL Yes - 27.28 3.82 030 24mm CT Yes - 3.28 4.35 031 20mmPT Yes - 51.12 6.15 032 45mm CT Yes - 6.28 5.94 033 28mm PT Yes - 4.22 3.25 034 38min SL Yes - 14.12 7.87 035 28mm CT Yes - 2.31 1.55 036 20mm PT Yes - 25.19 4.47 037 45mm CT Yes - 2.44 4.31 038 28mm PT Yes - 8.16 3.38 039 38mm SL Yes - 6.94 2.87 040 28mm CT Yes 5.63 4.13 Gray — Data Excluded (No match Pain or 118 MMSE), Dark Gray — Didn’t Close Properly Table 36 - Raw data (cont'd) Subject Package Testing # Type Opened Abort Time (s) Time to open (s) Time to close (s) 041 24mm PT No 14.41 - - 042 20mm CT Yes - 11.07 3.97 043 45min PT Yes - 8.43 3.28 044 24mm SL Yes - 27.75 4.53 045 24mm CT Yes - 3.56 7.66 046 20mm PT Yes - 39.22 3 047 45mm CT Yes - 6.88 3.97 048 28mm PT Yes - 4.78 2.37 049 38mm SL Yes - 20.16 9.38 050 28min CT Yes - 4.53 1.97 051 24mm PT No Past 70s - - 052 20mm CT Yes - 7.88 4.22 053 45mm PT Yes - 11.78 8.85 054 24mm SL No 27.34 - - 055 24mm CT Yes - 5.16 3.56 , 056 20mm PT No 33.72 - - 057 45mm CT Yes - 5.76 2.44 058 28mm PT No 35.59 - - 059 38mm SL No 16.03 - - 060 28mm PT No 10.31 - - 061 24mm PT No 16.13 - - 062 20mm CT Yes - 14.4 6.38 063 x x x x 064 45mm PT Yes - 7.56 6.72 065 24mm SL No 16.92 - - 066 24mm CT Yes - 4.84 2.6 067 20mm PT No 48.5 - - O68 45mm CT Yes - 6.06 3.03 069 28mm PT Yes - 22.5 4.12 070 38mm SL Yes - 7.32 3.5 071 x x x x x 072 28mm CT Yes - 6.22 2.19 073 24mm PT Yes - 19.22 3.69 074 20mm CT Yes - 3.25 2.62 075 45mm PT Yes - 11.38 4.25 076 24mm SL Yes - 18.78 .3 73.62,. I 077 24mm CT Yes - 5.57 5.56 078 20mm PT Yes - 26.16 6.71 079 45mm CT Yes - 3.53 10.88 080 28mm PT Yes - 3.46 , . 1.75 - Gray — Data Excluded (No match Pain or MMSE), Dark Gray - Didn’t Close Properly 119 Table 36 - Raw data (cont'd) Subject Package Testing # Type Opened Abort Time (s) Time to open (s) Time to close (s) 081 38mm SL Yes - 28.63 5.07 082 28mm CT Yes - 2.13 2.44 083 24mm PT Yes - 6.63 6.56 084 20mm CT Yes - 2.57 1.66 085 45mm PT Yes - 3.28 18.38 086 24min SL Yes - 9 - .. . , :2.— .. 087 24mm CT Yes - 2.5 1.15 088 20mm PT Yes - 28.72 3.5 089 45mm CT Yes - 2.4 1.62 090 28mm PT No 60.63 - - 091 38mm SL No 14.06 - - 092 28mm CT Yes - 4.84 6.85 093 24mm PT No 11.07 - - 094 20mm CT Yes — 2.16 2.12 095 45mm PT Yes - 8.88 9.59 096 24mm SL Yes - 16.16 3.35 097 24mm CT Yes - 2.84 3 098 20rmn PT Yes - 9.59 3.5 099 45mm CT Yes - 2.9 2.85 100 28mm PT Yes - 16.28 2.03 10] 38mm SL Yes - 8.91 21.53 g 102 28mm CT Yes - 8.56 5.41 103 24mm PT Yes - 6.62 4.29 104 20mm CT Yes - 2.31 2.25 105 45mm PT Yes - 2 4.78 106 24mm SL No 14.46 - - 107 24mm CT Yes - 2.68 2.06 108 20mm PT Yes - 6.31 3 109 45mm CT Yes - 3.06 2.47 110 28mm PT Yes - 48.21 42 Gray - Data Excluded (No match Pain or MMSE), Dark Gray — Didn’t Close Properly 120 Table 36 - Raw data (cont'd) Subject Package Testing # Type Opened Abort Time (s) Time to open (s) Time to close (5) 001 20mm CT Yes - 4.56 5.34 002 24mm PT No Past 705 - - 003 24mm CT Yes - 6.66 7.22 004 24mm SL Yes - 37.56 4.37 005 28mm PT No Past 70s - - 006 28mm CT Yes - 13 2.28 007 45mm PT Yes - 10.18 7.16 008 24mm SL Yes - 58.87 3.19 009 24mm CT Yes - 9.47 3.5 010 20mm PT Yes - 10.38 7.85 011 45mm CT Yes - 4.75 4.15 012 28mm PT Yes - 7.11 4.15 013 38mm SL Yes - 10.97 3.32 “7‘ 014 28mm CT Yes - 8.19 7.03 015 24mm PT Yes - 53.35 4 016 20mm CT Yes - 12.85 2.72 017 45mm PT Yes - 11.72 2.35 018 24mm SL Yes - 15.98 3.53 019 24mm CT Yes - 5.28 4.03 020 20mm PT Yes - 6.09 1.93 021 45mm CT Yes - 6.53 6.34 022 28mm PT No 18.97 - - 023 38mm SL Yes - 6.22 4.53 024 28mm CT Yes - 9.59 2.78 025 24mm PT No 15.87 - — 026 20mm CT Yes - 14.37 6.28 027 45mm PT No 15.9 - - 028 24mm SL Yes - 67.21 27.53 029 24mm CT Yes - 4.08 3.7 030 20mm PT Yes - 37.94 3.66 031 45mm CT Yes - 4.37 2.35 032 28mm PT No 4.28 - - O33 38mm SL Yes - 17.28 4.75 034 28mm CT Yes - 8.06 4.06 035 24mm PT Yes - 7.69 2 036 45min CT Yes - 7.28 4.75 037 28mm PT Yes - 6.44 3 038 38mm SL Yes - 10.16 3.72 039 28mm CT Yes - 4.57 2.5 040 24mm PT Yes 20.65 4.97 Gray — Data Excluded (No match Pain or 121 MMSE), Dark Gray — Didn’t Close Properly Table 36 - Raw data (cont'd) Subject Paclge Tesm # 2 Type Opened Abort Time is) Time to omn (s) Time to close (s) 041 20mm CT No 15 - - O42 45mm PT Yes - 12.99 8 043 24mm SL Yes - 13 7.84 044 24mm CT Yes - 3.5 3.97 045 20mm PT No 41.17 - - 046 45mm CT Yes - 6.28 2.79 047 28mm PT Yes - 14.56 6.71 048 38mm SL No 14.12 - - 049 28min CT Yes - 4.63 1.94 050 24mm PT No 41.19 - — 051 20mm CT Yes - 4.37 3.68 052 45mm PT Yes - 10.16 6.12 053 24mm SL No 8.74 - - 054 24mm CT Yes - 5.53 3.69 055 20mm PT No 7.5 - - 056 45mm CT Yes - 4.12 3.21 057 28mm PT Yes - 8.32 2.81 058 38mm SL No 20.37 - - 059 28mm CT Yes - 3.81 2 060 24mm PT Yes - 4.84 5.41 061 20mm CT Yes - 2.15 1.59 062 45mm PT Yes - 11.94 5.53 063 x x x x X 064 24mm SL No 24.5 - — 065 24mm CT Yes - 5.25 9.19 066 20mm PT Yes - 3.72 2.41 067 45mm CT Yes - 3.72 5.78 068 28mm PT Yes - 11.03 3.81 069 38mm SL Yes - 12.35 3.28 070 28mm CT Yes - 2.69 2.65 071 x x x x X 072 24mm PT No 28.31 - - 073 20mm CT Yes - 3.25 1.56 074 45mm PT Yes - 9.93 6.12 075 24mm SL Yes - 21.63 3.94 076 24mm CT Yes - 3.75 3.65 077 20mm PT No 52.56 - - 078 45mm CT Yes - 4.07 3.19 079 28mm PT Yes - 2.37 3.57 080 38mm SL Yes - 5.68 4.81 Gray — Data Excluded (No match, Pain or MMSE) 122 Table 36 - Raw data (cont'd) Subject Package Testing # 2 Type Opened Abort Time (s) Time to open (8) Time to close (s) 081 28mm CT Yes - 4.06 1.97 082 24mm PT Yes - 5.13 2.94 083 20mm CT Yes - 3.1 2.97 084 45mm PT Yes - 4.31 4.62 085 24mm SL Yes - 4.94 ,, . ,,3.65 , : 086 24mm CT Yes - 4 2 087 20mm PT Yes - 3.59 1.82 088 45mm CT Yes - 2.9 1.35 089 28mm PT Yes - 28.21 2.88 090 38mm SL No 20.15 - - 091 28mm CT Yes - 11 1.87 092 24mm PT Yes - 27.1 3.37 093 20mm CT Yes - 2.87 2.06 094 45mm PT Yes - 2.09 3.69 095 24mm SL No 19.13 - - 096 24mm CT Yes - 5.86 1.69 097 20mm PT Yes - 27.47 3.44 098 45mm CT Yes - 3 1.9 099 28mm PT Yes - 8.38 2.65 100 38mm SL Yes - 9.06 2.91 101 28mm CT Yes - 3.53 2.28 102 24mm PT No 21.44 - - 103 20mm CT Yes - 2.92 2.87 104 45mm PT Yes - 10.15 2.72 105 24mm SL Yes - 7.44 3 106 24mm CT Yes - 5.28 3.53 107 20mm PT Yes - 5.22 2.97 108 45mm CT Yes - 1.88 2 109 28mm PT Yes - 4.56 2.16 110 38mm SL Yes 67.25 5.31 Gray — Data Excluded (No match Pain or MMSE), Dark Gray — Didn’t Close Properly 123 Table 36 - Raw data (cont'd) Subject Package Testing # 3 Type Opened Abort Time (s) Time to open (8) Time to close (s) 001 24mm PT No Past 705 - - 002 24mm CT Yes - 4.4 3.3 003 24mm SL No 48.88 - - 004 28mm PT Yes - 13.62 3.82 005 28mm CT Yes - 6.38 1.9 006 38mm SL No 7.81 - - 007 24mm SL No 21.15 - - 008 24mm CT Yes - 8.66 5.06 009 20mm PT No 25.12 - - 010 45mm CT Yes - 3.25 2.84 011 28mm PT Yes - 19.29 4.07 012 38mm SL Yes - 9.16 3.47 013 28mm CT Yes - 7.22 2.37 014 24mm PT No 60.82 - - 015 20mm CT Yes - 8.65 3.44 016 45mm PT Yes - 10.22 5.34 017 24mm SL No 25.66 - — 018 24mm CT Yes - 6.17 3.41 019 20mm PT Yes - 11.37 5.81 020 45mm CT Yes - 5.38 2.34 021 28mm PT No 67.93 - - 022 38mm SL No 23.37 - - 023 28mm CT Yes - 4.63 2.18 024 24mm PT No 55.12 - - 025 20mm CT Yes - 7.72 4.18 026 45mm PT Yes - 23.81 5.04 027 24mm SL No 9.88 - - 028 24mm CT Yes - 5.28 2.84 029 20mm PT No Past 70s - - O30 45mm CT Yes - 5.37 1.69 03] 28mm PT Yes - 3.22 3.03 032 38mm SL No 9.31 - - 033 28mm CT Yes - 4.22 2.15 034 24mm PT Yes - 12.59 2 035 20mm CT Yes - 3.4 2.16 036 28mm PT Yes - 16.85 17.12 037 38mm SL Yes - 9.85 3.22 038 28mm CT Yes - 4.66 2.03 039 24mm PT Yes - 20.22 3.78 040 20mm CT Yes - 4.41 2.81 Gray - Data Excluded (No match, Pain or MMSE) 124 Table 36 - Raw data (cont'd) Subject Package Testing # Type Opened Abort Time (s) Time to open (s) Time to close (8) 041 45mm PT No 28.06 - - 042 24mm SL Yes - 17.69 5.12 043 24mm CT Yes - 3.87 5.47 044 20mm PT Yes - 11.65 4.03 045 45mm CT Yes - 3.21 2.47 046 28mm PT Yes - 8.94 2.6 047 38mm SL Yes - 21.16 6.65 048 28mm CT Yes - 3.03 2.03 049 24mm PT Yes - 27.66 5.25 050 20mm CT Yes - 3.72 2.59 051 45min PT Yes - 4.21 5.22 052 24mm SL No 25.84 - - 053 24mm CT Yes - 14.5 2.63 054 20mm PT Yes - 20.65 4.22 055 45mmCT Yes - 3.28 9.16 056 28mm PT No 23.57 - - 057 38mm SL Yes - 7.32 4.54 058 28mm CT Yes - 6.19 3.72 059 24mm PT Yes - 15.6 2.28 060 20mm CT Yes - 5.41 3 061 45mm PT No 12.93 - - 062 24mm SL No 20.66 - - 063 x x x x X 064 24mm CT Yes - 5.44 5.9 065 20mm PT No 20.56 - - 066 45mmCT Yes - 2.81 2.12 067 28mm PT No Past 70$ - - 068 38mm SL Yes - 12.9 ‘ 3.5;?- i 069 28mm CT Yes - 4.96 2.69 070 24111111 PT Yes - 5.75 3.19 071 x x x x X 072 20mm CT Yes - 3.09 2.03 073 45mm PT Yes - 7.28 3.03 074 24mm SL Yes - 7.37 .. ‘ 339," _.- 075 24mm CT Yes - 7.28 4.91 076 20mm PT No 50.38 - - 077 45mm CT Yes - 4.47 2.13 078 28mm PT Yes - 1 1.35 6.22 079 38mm SL Yes - 15.04 4.75 080 28mm CT Yes 4.97 1.82 Gray — Data Excluded (No match Pain or 125 MMSE), Dark Gray — Didn’t Close Properly Table 36 - Raw data (cont'd) Subject Package Testing # 3 1m Opened Abort Time (s) Time to open (5) Time to close (s) 081 24mm PT No 19.44 - - 082 20mm CT Yes - 1.81 5.5 083 45mm PT Yes - 3.31 2.28 084 24mm SL Yes - 11.31 2.94 085 24mm CT Yes - 3.85 2.25 086 20mm PT Yes — 6 3 087 45mm CT Yes - 3.19 1.46 088 28mm PT Yes - 3.16 1.35 089 38mm SL Yes - 21.15 4.09 090 28mm CT Yes - 3.59 3.1 091 24mm PT No 17.75 - - O92 20mm CT Yes - 4.22 2.63 093 45mm PT Yes - 2.31 3.88 094 24mm SL No 13.25 - - 095 24mm CT Yes - 5.65 2.88 096 20mm PT Yes - 12.86 1.6 097 45mm CT Yes - 2.22 2.18 098 28mm PT Yes - 5.03 2.25 099 38mm SL Yes - 6.53 3.22 100 28mmCT Yes — 4.12 2.91 101 24mm PT Yes - 14.25 2.44 102 20mm CT Yes - 4 2.07 103 45mm PT Yes - 4.66 4.75 104 24mm SL Yes - 11.72 6.31 105 24mm CT Yes - 1.97 2.5 106 20mm PT No 16.37 - - 107 45mm CT Yes - 2.66 2.44 108 28mm PT Yes - 3.43 2.19 109 38mm SL Yes - 4 5.97 110 28mm CT Yes - 4.09 1.63 Gray — Data Excluded (No match, Pain or MMSE) 126 Table 36 - Raw data (cont'd) Subject Package Testhg # 4 Type Opened Abort Time (s) Time to open (5) Time to close (s) 001 24mm CT Yes - 5 1.66 002 24mm SL Yes - 20.09 3:5,; ,‘LZ'; 003 28mm PT Yes - 15.31 6.04 004 28mm CT Yes - 4.66 2 005 38mm SL Yes - 33.97 5.16 006 45mm PT Yes - 7.25 3.22 007 24mm CT No 10.97 - - 008 20mm PT No Past 70$ - - 009 45mm CT Yes - 3.31 4 010 28mm PT Yes — 6.47 2.91 011 38mm SL Yes - 14.5 3.3 012 28mm CT Yes - 2.56 2.25 013 24mm PT No 30.91 - - 014 20mm CT No 34.67 - - 015 45mm PT Yes - 10.03 1.53 016 24mm SL Yes - 17.88 4.78 017 24mm CT Yes - 5.5 2.15 018 20mm PT No 20.62 - - 019 45mm CT Yes - 4.38 3.35 020 28mm PT Yes - 5.09 1.65 021 38mm SL Yes - 20.38 9.32 022 28mm CT Yes - 4.63 1.9 023 24mm PT Yes - 10.13 3.16 024 20mm CT Yes - 6.53 2.46 025 45mm PT Yes - 5.16 5.84 026 24mm SL No 21.63 - - 027 24mm CT Yes - 7.23 3 028 20mm PT No Past 705 - - 029 45mm CT Yes - 3.97 2.13 030 28mm PT Yes - 7.15 3.66 031 38mm SL Yes - 16.93 3.01 032 28mm CT Yes - 7.81 1.66 033 24mm PT Yes - 12.59 4.28 034 20mm CT Yes - 4.38 4.25 035 45mm PT Yes - 4.26 4.35 036 38mm SL No 37.19 - - 037 28mm CT Yes - 4.72 2.59 038 24mm PT Yes - 7.72 2.32 039 20mm CT Yes - 3.58 2.12 040 45mm PT Yes 5.37 6.43 Gray — Data Excluded (No match Pain or MMSE), Dark Gray — Didn’t Close Properly 127 Table 36 - Raw data (cont'd) Subject Package Testing # 4 Type Opened Abort Time (s) Time to open (5) Time to close (s) 041 24mm SL No 13.38 - - 042 24mm CT Yes - 5 4.34 043 20mm PT No 18.97 - - 044 45mm CT Yes - 2.84 2.63 045 28mm PT Yes - 9.44 2.81 046 38mm SL Yes - 9.32 7 73.65. g; ' 047 28mm CT Yes - 5.44 3.97 048 24mm PT Yes - 11.78 3.28 049 20mm CT Yes - 3.78 2.84 050 45mm PT Yes - 14.44 3.66 051 24mm SL No 45.3 - - 052 24mm CT Yes - 8.53 4.09 053 20mm PT No 12.84 - - 054 45mm CT Yes - 3.91 3.56 055 28mm PT Yes - 6.28 3.25 056 38mm SL No 35.46 - - 057 28mmCT Yes - 8.84 2.35 058 24mm PT No 40.16 - - 059 20mm CT Yes - 3.34 2.09 060 45mm PT Yes - 4.85 4.57 061 24mm SL No 13.85 - - 062 24mm CT Yes - 6.22 6.84 063 x x ,x x X 064 20mm PT No 34.28 - - 065 45mm CT Yes - 2.62 4.88 066 28mm PT Yes - 3.5 2.31 067 38mm SL No 51.5 - - 068 28mm CT Yes - 4.69 2.6 069 24mm PT Yes - 36.41 4 070 20mm CT Yes - 5.03 1.91 071 x x x x X 072 45mm PT Yes - 3.44 2.17 073 24mm SL Yes - 7.56 ,4 1.78 . 074 24mm CT Yes - 2.78 2.57 075 20mm PT Yes - 47.41 3.09 076 45mm CT Yes - 3.03 2.63 077 28mm PT Yes - 13 2.88 078 38mm SL Yes - 13.6 5.22 079 28mm CT Yes - 4.43 8 080 24mm PT Yes 4.62 2.29 Gray - Data Excluded (No match Pain or 128 MMSE), Dark Gray - Didn’t Close Properly Table 36 - Raw data (cont'd) Subject Package Testing # 4 Type Opened Abort Time (s) Time to open (5) Time to close (5) 081 20mm CT Yes - 3.97 2.57 082 45mm PT Yes - 1.94 2.47 083 24mm SL Yes - 9.5 4.59 084 24mm CT Yes - 2.44 2.22 085 20mm PT Yes - 32.72 2.5 086 45mm CT Yes - 3.72 2.02 087 28mm PT Yes - 4.31 2.28 088 38mm SL Yes ~ 30.62 2.62 089 28mm CT Yes - 3.81 2.32 090 24mm PT No 24.94 - - 091 20mm CT Yes - 2.15 2 092 45mm PT Yes - 7.69 5.94 093 24mm SL Yes - 8.9 4.84 094 24mm CT Yes - 1.59 2.66 095 20mm PT Yes - 16.69 4.72 096 45mm CT Yes - 2.22 1.6 097 28mm PT Yes - 4.65 3.06 098 38mm SL Yes - 9.62 g 3.59 099 28mm CT Yes - 3.06 2.32 100 24mm PT Yes - 27.09 3.31 101 20mm CT Yes - 1.75 2.69 102 45mm PT Yes - 4.69 2.18 103 24mm SL No 17.88 - - 104 24mm CT Yes - 3.97 2.15 105 20mm PT Yes - 4.75 2.38 106 45mm CT Yes - 7.26 2.65 107 28mm PT Yes - 2.5 2.68 108 38mm SL Yes - 4.15 2.38 109 28mm CT Yes - 2.03 3.91 1 10 24mm PT No Past 70s - Gray — Data Excluded (No match Pain or MMSE), Dark Gra 129 y — Didn’t Close Properly Table 36 - Raw data (cont'd) Subject Package Testing # 5 Type Opened Abort Time (s) Time to open (5) Time to close (s) 001 24mm SL No Past 705 - - 002 28mm PT Yes - 8.69 5.75 003 28mm CT Yes - 7.71 4.23 004 38mm SL Yes - 13.44 4.31 005 45mm PT Yes - 12.44 4.57 006 45mm CT Yes - 2.97 4 007 20mm PT No 28.65 - - 008 45mm CT Yes - 6.59 5 009 28mm PT No 19.91 - - 010 38mm SL Yes - 9.65 4 011 28mm CT Yes - 5.28 3 012 24mm PT Yes - 8.87 4.05 013 20mm CT Yes - 18.77 2.59 014 45mm PT Yes - 25.71 4.97 015 24mm SL Yes - 30.79 2.25 016 24mm CT Yes - 8.54 4.32 017 20mm PT No 20.5 - - 018 45mm CT Yes - 1.91 4.22 019 28mm PT Yes - 5.69 5.47 020 38mm SL Yes - 61.28 4.59 021 28mm CT Yes - 33.53 6.56 022 24mm PT No 23.88 - - 023 20mm CT Yes - 2.5 1.5 024 45mm PT Yes - 16.63 2.16 025 24mm SL No 12.32 - - 026 24mm CT Yes - 9.53 6.09 027 20mm PT No 13.16 - - 028 45mm CT Yes - 8.6 4.85 029 28mm PT Yes - 45.45 ‘ 3.9.8:." (1,; . 030 38mm SL No 13.78 - - 031 28mm CT Yes - 2.78 2.25 032 24mm PT No 15.46 - - 033 20mm CT Yes - 4.57 2.15 034 45mm PT Yes - 21.5 4.85 035 24mm SL Yes - 9.13 4.6 036 28mm CT Yes - 6.35 4.22 037 24mm PT Yes - 8 3.65 038 20mm CT Yes - 5.1 2.56 039 45mm PT Yes - 9.19 5.9 040 24mm SL Yes 24.28 3.44 Gray — Data Excluded (No match Pain or MMSE), Dark Gray — Didn’t Close Properly 130 Table 36 - Raw data (cont'd) Subject Package Testing # 5 Type Opened Abort Time (s) Time to open (8) Time to close (s) 041 24mm CT No 12.31 - - 042 20mm PT No 52.13 - - 043 45mm CT Yes - 4.37 3.31 044 28mm PT Yes - 3.07 10.34 045 38mm SL Yes - 9.69 4.53 046 28mm CT Yes - 5.03 2.34 047 24mm PT Yes - 11.09 3.15 048 20mm CT Yes - 3.03 2.47 049 45mm PT Yes - 9.4 3.78 050 24mm SL Yes - 19.56 5.43 051 24mm CT Yes - 2.53 4.03 052 20mm PT No 21.7 - - 053 45mm CT No 7.34 - - 054 28mm PT Yes - 5.06 3.47 055 38mm SL Yes - 34.57 3.8 056 28mm CT Yes - 4.04 4.31 057 24mm PT Yes - 11.72 3.16 058 20mm CT Yes - 9.28 11.44 059 45mm PT Yes - 15.28 2.25 060 24mm SL No 5.78 - - 061 24mm CT Yes - 2.6 2.53 062 20mm PT No 26.72 - - 063 x x x x X 064 45mm CT Yes - 2.88 6.47 065 28mm PT Yes - 15.31 5.97 066 38mm SL No 21.19 - - 067 28mm CT Yes - 3.6 3.16 068 24mm PT No Past 70s - - 069 20mm CT Yes - 5.04 5.63 070 45mm PT Yes - 16.78 2.62 071 x . x x x X 072 24mm SL Yes - 7.19 3.19 073 24mm CT Yes - 2.57 1.56 074 20mm PT Yes - 12.94 3.34 075 45mm CT Yes - 5.66 3 076 28mm PT No 31.47 - - 077 38mm SL Yes - 13.09 4.56 078 28mm CT Yes - 5.28 2.91 079 24mm PT Yes - 17 2.79 080 20mm CT Yes - 2.97 1.84 Gray — Data Excluded (No match Pain or MMSE), Dark Gray — Didn’t Close Properly 131 Table 36 - Raw data (cont'd) Subject Package Testing # 5 Type Opened Abort Time (s) Time to open (8) Time to close (s) 081 45mm PT Yes - 5.13 3.22 082 24mm SL Yes - 15.45 2.82 083 24mm CT Yes - 2.22 2.03 084 20mm PT Yes - 30.25 3.75 085 45mm CT Yes - 2.44 2.37 086 28mm PT Yes - 5.27 2.03 087 38mm SL Yes - 27.19 1.72 088 28mm CT Yes - 6.5 2.02 089 24mm PT Yes - 5.03 2.83 090 20mm CT Yes - 2.1 3.35 091 45mm PT No 11.5 - - 092 24mm SL No 29.96 - - 093 24mm CT Yes — 1.71 1.97 094 20mm PT Yes - 3.47 1.78 095 45mm CT Yes - 3.44 3.91 096 28mm PT Yes - 8.07 1.5 097 38mm SL Yes - 33.91 5.03 098 28mm CT Yes - 2.69 3.78 099 24mm PT Yes - 6.75 2.94 100 20mm CT Yes - 3.09 1.59 101 45mm PT Yes - 9.28 2.85 102 24mm SL No 13.78 - - 103 24mm CT Yes - 2.85 3.4 104 20mm PT No Past 708 - ~ 105 45mm CT Yes - 1.65 1.81 106 28mm PT No 30.35 - - 107 38mm SL Yes - 4.47 2.15 108 28mm CT Yes - 1.82 2.07 109 24mm PT Yes - 5.53 3.03 110 20mmCT Yes — 2.82 1.88 Gray — Data Excluded (No match, Pain or MMSE) 132 Table 36 - Raw data (cont'd) Subject Package Testipg # 6 Type Opened Abort Time (s) Time to open (8) Time to close (8) 001 28mm PT No Past 70$ - - 002 28mm CT Yes - 11.22 3.53 003 38mm SL No 30.56 - - 004 45mm PT Yes - 10.31 2.66 005 45min CT Yes - 2.93 2.09 006 20mm PT No 9.41 - - 007 45mm CT x x x X 008 28mm PT No 42.5 - - 009 38mm SL No 14.66 - - 010 28mm CT Yes - 4.16 3.09 011 24mm PT No Past 70s - - 012 20mmCT Yes - 3.41 3.41 013 45mm PT Yes - 9.82 3 014 24mm SL No 41.44 - - 015 24mm CT Yes - 8.56 3 016 20mm PT Yes - 56.84 4.28 017 45mm CT Yes - 3.81 2.06 018 28mm PT Yes - 5 3.22 019 38mm SL Yes - 31.65 4.08 020 28mm CT Yes - 3.5 2.66 021 24mm PT No 28.85 - - 022 20mm CT No 16.87 - - 023 45mm PT Yes - 7.6 1.75 024 24mm SL No 61.29 - - 025 24mm CT Yes - 6.15 3.97 026 20mm PT No 14.41 - - 027 45mm CT Yes - 3.41 4.66 028 28mm PT No 64.88 - - 029 38mm SL Yes - 14.47 “ 3.75‘f 030 28mm CT Yes - 4.22 2.59 031 24mm PT Yes - 21 7.44 032 20mm CT No 3.87 - - 033 45mm PT Yes - 16.72 2.41 034 24mm SL Yes - 19.93 4.28 035 24mm CT Yes - 2.25 2.47 036 24mm PT Yes - 15.97 3.97 037 20mm CT Yes - 3.78 2.26 038 45mm PT Yes - 6.41 2.72 039 24mm SL Yes - 7.41 3.41 040 24mm CT Yes 4.07 2.9 Gray — Data Excluded (No match Pain or MMSE), Dark Gray — Didn’t Close Properly 133 Table 36 - Raw data (cont'd) Subject Package Testifl # 6 Type Opened Abort Time (s) Time to open (5) Time to close (5) 041 20mm PT No 13.34 - - 042 45mm CT Yes - 5.44 4.63 043 28mm PT Yes - 9.84 2.41 044 38mm SL Yes - 11.28 4.56 045 28mm CT Yes - 3.75 2.34 046 24mm PT Yes - 7.28 2.5 047 20mm CT Yes - . 4.13 2.66 048 45mm PT Yes - 7.84 2.13 049 24min SL Yes - 10.28 9.53 050 24mm CT Yes - 4.53 3 051 20mm PT No 47.56 - - 052 45mm CT Yes - 3.78 4.03 053 28mm PT No 10 - - 054 38mm SL Yes - 21.66 4.4 055 28mmCT Yes - 4.38 4.18 056 24mm PT No 18.1 - - 057 20mm CT Yes - 6.69 2.37 058 45mm PT Yes - 12.18 8.96 059 24mm SL No 7.28 - - 060 24mm CT No 6.4 - - 061 20mm PT No 10.09 - - 062 28mm PT Yes - 10.34 4.34 063 x x x x X 064 28min PT Yes - 24.14 5.93 065 38mm SL No 11.22 - — 066 28mm CT Yes - 2.15 1.69 067 24mm PT No 35.41 - - 068 20mm CT Yes - 4.63 3.34 069 45mm PT Yes - 7.12 2.75 070 24mm SL No 25.09 - - 071 x x x x X 072 24mm CT Yes - 2.16 T , 2.19] 073 20mm PT Yes - 4.65 7.81 074 45mm CT Yes - 2.72’ 2.03 075 28mm PT Yes - 13.78 3.93 076 38mm SL Yes - 6.97 6.25 077 28mm CT Yes - 3.68 2.07 078 24mm PT Yes - 14.97 6.75 079 20mm CT Yes - 2.56 2.56 080 45mm PT Yes - 4.25 3.54 Gray — Data Excluded (No match Pain or MMSE), Dark Gray - Didn’t Close Properly 134 Table 36 - Raw data (cont'd) Subject Package Testing # 6 Type Opened Abort Time (s) Time to open (s) Time to close (s) 081 24mm SL Yes - 20.97 12.81 082 24mm CT Yes - 1.78 2.22 083 20mm PT Yes - 6.62 2.37 084 45mm CT Yes - 7.69 1.75 085 28mm PT Yes - 4.84 1.72 086 38mm SL Yes - 7.53 2.03 087 28mm CT Yes - 3.4 2.85 088 24mm PT Yes - 10.03 2.02 089 20mm CT Yes - 2.72 2.25 090 45mm PT Yes - 32.53 2 091 24mm SL No 8.87 - - 092 24mm CT Yes - 4.66 2.09 093 20mm PT Yes - 7.19 2 094 45mm CT Yes - 2.56 1.66 095 28mm PT Yes - 14.54 3.1 096 38mm SL Yes - 8.71 1.81 097 28mm CT Yes - 4.78 2.59 098 24mm PT Yes - 7.13 2.66 099 20mm CT Yes - 2.06 1.97 100 45mm PT Yes - 5.69 1.62 101 24mm SL Yes - 17.84 8.78 102 24mm CT Yes - 4.88 2.53 103 20mm PT Yes - 4.28 2.81 104 45mm CT Yes - 2.72 2.07 105 28mm PT Yes - 8.44 4.35 106 38mm SL No 11.81 - - 107 28mm CT Yes - 2.31 1.75 108 24mm PT Yes - 5.28 2.03 109 20min CT Yes - 3.19 2.38 110 45mm PT Yes - 19.53 4.62 Gray — Data Excluded (No match Pain or MMSE), Dark Gray -— Didn’t Close Properly 135 Table 36 - Raw data (cont'd) Subject Packa; Testlli # 7 Type Opened Abort Time (s) Time to open (s) Time to close (s) 001 28mm CT Yes - 4.38 1.53 002 38mm SL Yes - 41.81 ' 6,34 ~ 003 45mm PT Yes - 1 1 4.78 004 45mm CT Yes - 2.68 4.03 005 20mm PT No Past 70s - - 006 20mm CT No 12 - - 007 28mm PT x x x X 008 38mm SL No 49.88 - - 009 28mm CT Yes - 5.03 6.31 010 20mm CT Yes - 53.29 4.66 01 1 20mm CT No 64.84 - - 012 45mm PT Yes - 5.65 3.87 013 24mm SL No 23.92 — - 014 24mm CT Yes - 13.87 4.34 015 20mm PT No 30 - - 016 45mm CT Yes - 3.45 2.32 017 28mm PT Yes - 6.6 2.15 018 38mm SL No 10.63 - - 019 28mm CT Yes - 2.45 2.25 020 24mm PT Yes - 7.09 2.54 021 20mm CT Yes - 9.22 5.07 022 45mm PT Yes - 6.78 2.88 023 24mm SL Yes - 9.97 4.53 024 24mm CT Yes - 4.14 2.19 025 20mm PT No 10.44 - - 026 45mm CT Yes - 7.08 3.03 027 28mm PT Yes - 10.31 6.28 028 38mm SL Yes - 21.05 16.22 029 28mm CT Yes - 5.1 1.84 030 24mm PT Yes - 17.72 4 031 20mm CT Yes - 4.29 2.28 032 45mm PT No 4.5 - - 033 24mm SL Yes - 9.31 2.82 034 24mm CT Yes - 4.69 3.25 035 20mm PT Yes - 7.4 5.31 036 20mm CT Yes - 6.6 3.03 037 45mm PT Yes - 8.78 3.34 038 24mm SL Yes - 7.44 4.22 039 24mm CT Yes - 3.34 3.12 040 20mm PT No 36.28 - - Gray — Data Excluded (No match Pain or MMSE), Dark Gray — Didn’t Close Properly 136 Table 36 - Raw data (cont'd) Subject Package Testuyg # 7 Tm Opened Abort Time (s) Time to open (8) Time to close (s) 041 45mm CT No 14.13 - - 042 28mm PT No 17.88 - - 043 38mm SL Yes - 6.63 3.03 044 28mm CT Yes - 2.19 2.19 045 24mm PT No 19.84 - - O46 20mm CT Yes - 4.72 2.53 047 45mm PT Yes - 11.76 2.75 048 24mm SL Yes - 15.54 3.59 049 24mm CT Yes - 4.12 3.03 050 20mm PT No 27.72 - - 051 45mm CT Yes - 2.5 2 052 28mm PT No 14.13 - - 053 38mm SL No 10.56 - - 054 28mm CT Yes - 5.03 4.41 055 24mm PT Yes - 33.22 2.97 056 20mm CT Yes - 3.15 3.88 057 45mm PT Yes - 5.31 3.6 058 24mm SL No 26.53 - - 059 24mm CT Yes - 2.13 2.09 060 20mm PT No 8.19 - - 061 28mm PT Yes - 8.09 3.68 062 38mm SL No 20.67 - - 063 x x x x X 064 38mm SL Yes - 15.62 9.34 065 28mm CT Yes - 3.4 4.13 066 24mm PT No 18.31 - - 067 20mm CT Yes - 6.1 5.05 068 45mm PT Yes - 8.28 3.47 069 24mm SL Yes - 25.81 4.38 070 24mm CT Yes - 3.28 1.72 071 x x x x X 072 20mm PT No 21.85 - - 073 45mm CT Yes - 1.68 2.04 074 28mm PT Yes - 6.63 5.59 075 38mm SL Yes - 5.68 3.83 076 28mm CT Yes - 4.06 3.16 077 24mm PT Yes - 18.81 2.94 078 20mm CT Yes - 4.59 3 079 45mm PT Yes - 3.59 2 080 24mm SL Yes - 10.97 2.56 Gray — Data Excluded (No match, Pain or MMSE) 137 Table 36 - Raw data (cont'd) Subject Package Testing # 7 Type Opened Abort Time (s) Time to open (8) Time to close (s) 081 24mm CT Yes - 4.28 2.1 082 20mm PT Yes - 4.87 2.47 083 45rmn CT Yes - 3.44 2.74 084 28mm PT Yes - 8.16 1.84 085 38mm SL Yes - 14.87 4.31 086 28mm CT Yes - 3.78 1.97 087 24mm PT Yes - 4.41 1.94 088 20mm CT Yes - 3.38 2.02 089 45mm PT Yes - 11.59 2.21 090 24mm SL No 8.22 - - 091 24mm CT Yes - 4.06 4.29 092 20mm PT Yes - 10.38 4.28 093 45mm CT ‘ Yes - 1.68 1.75 094 28mm PT Yes - 2.31 9.53 095 38mm SL Yes - 12.5 4.87 096 28mm CT Yes - 2.4 2.13 097 24mm PT Yes - 62.29 2.41 098 20mm CT Yes - 3.69 2.75 099 45mm PT Yes - 5.5 2.41 100 24mm SL Yes - 8.13 1.53 101 24mm CT Yes - 1.75 2.88 102 20mm PT No 23.31 — - 103 45mm CT Yes - 4.32 2 104 28mm PT Yes - 42.64 3.75 105 38mm SL Yes - 6.06 4.91 106 28mm CT Yes - 6.88 3.35 107 24mm PT Yes - 8.34 2.47 108 20mm CT Yes - 1.65 2 109 45mm PT Yes - 3.53 3.82 l 10 24mm SL Yes - 14.44 2.66 Gray — Data Excluded (No match Pain or MMSE), Dark Gray — Didn’t CloseProperly 138 Table 36 - Raw data (cont'd) Subject Package Tesgg # 8 Type Opened Abort Time (s) Time to opetgs) Time to close (5) 001 38mm SL Yes - 60.16 4 002 45mm PT Yes - 70 3.31 003 45mm CT No 40.19 - - 004 20mm PT Yes, - 18.56 2.94 005 20mm CT Yes - 4 2.87 006 24mm PT No 8.03 - - 007 38mm SL x x x X 008 28mm CT Yes - 3.07 3 009 24mm PT No 15.97 - - 010 45mm PT Yes - 4.59 3.38 01 1 45mm PT No Past 70$ - - 012 24mm SL Yes - 7.13 2 " 013 24mm CT No 17.32 - - 014 20mm PT No 52.4 - - 015 45mm CT Yes - 3.82 3 016 28mm PT Yes - 9.18 4.41 017 38mm SL No 16.57 - - 018 28mmC1‘ Yes - 5.47 2.81 019 24mm PT Yes - 8.47 7.68 020 20mm CT Yes - 2.53 2.44 021 45mm PT No 55.72 - - 022 24mm SL No 23.65 - — 023 24mm CT Yes - 3.69 3.79 024 20mm PT No 47.62 - - 025 45mm CT Yes - 3.25 4.97 026 28mm PT No 21.1 - - 027 38mm SL No 9.75 - - 028 28mm CT Yes - 5.19 4.03 029 24mm PT No 62.65 - - 030 20mm CT Yes - 4.78 2.62 031 45mm PT Yes - 5.53 3.31 032 24mm SL No 2.31 - - 033 24mm CT Yes - 2.34 2.53 034 20mm PT Yes - 8.56 2.28 035 45mm CT Yes - 3 2.69 036 45mm PT Yes - 9.65 4.56 037 24mm SL Yes - 7.91 3 038 24mm CT Yes - 4.22 4.37 039 20mm PT Yes - 9.82 2.87 040 45mm CT Yes - 2.72 3.4 Gray - Data Excluded (No match Pain or MMSE), Dark Gray — Didn’t Close Properly 139 Table 36 - Raw data (cont'd) Subject Paflge Testing # 8 Type Opened Abort Time (s) Time to open (5) Time to close (s) 041 28mm PT No 28.07 - - 042 38mm SL No 12 - - 043 28mm CT Yes - 4.66 2.53 044 24mm PT Yes - 6.16 1.97 045 20mm CT No 5.91 - - 046 45mm PT Yes - 5.75 2.19 047 24mm SL Yes - 20 5.78 048 24mm CT Yes - 3.97 2.28 049 20mm PT Yes - 11.35 2.94 050 45mmCT Yes - 2.81 2.59 051 28mm PT Yes - 63.95 8.83 052 38mm SL No 11.85 - - 053 28mm CT Yes - 2.97 2.66 054 24mm PT No 38.34 - - 055 20mm CT Yes - 4.15 2.32 056 45mm PT Yes - 10.82 5.79 057 24mm SL Yes - 12.56 5.03 058 24mm CT No 16.44 - - 059 20mm PT No 14.65 - - 060 45mmCT Yes - 3.84 3.13 061 38mm SL No 8.25 - - 062 45mm CT Yes - 3.22 3.29 063 x x x x X 064 28mm CT Yes - 3.5 2.9 065 24mm PT No 10.21 - - 066 20mm CT Yes - 2.94 2.06 067 45mm PT Yes - 29.79 2.81 068 24mm SL Yes - 42.12 ‘ 10.797, 069 24mm CT Yes - 5.68 2.9 070 20mm PT No 26.35 - - 071 x x x x X 072 45mm CT Yes - 1.84 5.56 073 28mm PT Yes - 11.81 2.15 074 38mm SL Yes - 6.56 2.65 075 28mm CT Yes - 5.31 2.31 076 24mm PT No 35.63 - - 077 20mm CT Yes - 6.84 2.57 078 45mm PT Yes - . 7.09 3.44 079 24mm SL Yes - 17.03 4.75 080 24mm CT Yes - 5.75 3.16 Gray — Data Excluded (No match Pain or MMSE), Dark Gray - Didn’t Close Properly 140 Table 36 - Raw data (cont'd) Subject PackaLeTestipg # 8 Type Opened Abort Time (s) Time to open (s) Time to closgs 081 20mm PT Yes - 11.81 2.72 082 45mm CT Yes - 2.12 2.72 083 28mm PT Yes - 2.81 2.03 084 38mm SL Yes - 1 1.97 3 085 28mm CT Yes - 2.91 1.63 086 24mm PT Yes - 5.63 2 087 20mm CT Yes - 3.25 2.68 088 45mm PT Yes - 6.32 2.03 089 24mm SL Yes - 16.16 4.23 090 24mm CT Yes - 3.69 4.19 091 20mm PT No 7.65 - - 092 45mm CT Yes - 2.69 2.63 093 28mm PT Yes - 2.28 2.28 094 38mm SL Yes - 6.19 1.53 095 28mm CT Yes - 2.93 3.84 096 24mm PT Yes - 7.84 1.66 097 20mm CT Yes - 3.22 2.12 098 45mm PT Yes - 5.41 3.35 099 24mm SL No 14.41 - - 100 24mm CT Yes - 1.82 1.56 101 20mm PT Yes - 6.28 2 102 45mm CT Yes - 3.12 1.69 103 28mm PT Yes - 10.35 2.66 104 38mm SL Yes - 17.84 3.78 105 28mm CT Yes - 1.69 2.25 106 24mm PT No 19.23 - - 107 20mm CT Yes - 1.87 2.1 108 45mm PT Yes - 2.56 3.76 109 24mm SL Yes - 12.91 7.53 110 24mm CT Yes - 1.78 1.75 Gray — Data Excluded (No match, Pain or MMSE) 141 Table 36 - Raw data (cont'd) Subject Package Testing # 9 Type Opened Abort Time (s) Time to (megs) Time to close (8) 001 45mm PT Yes - 18.2? 3.97 002 45mm CT Yes - 4.5 2.72 003 20mm PT No 40.19 - - 004 20mm CT Yes - 13.25 2.16 005 24mm PT Yes - 25.03 3 006 24mm CT No 8.81 - - 007 28mm CT x x x X 008 24mm PT No 39.25 - - 009 20mm CT Yes - 5.75 3.63 010 24mm SL No Past 70s - - 011 24mm SL Yes - 37.42 4.78 012 24mm CT Yes - 2.85 2.87 013 20mm PT No 37.33 — - 014 45mm CT Yes - 8.18 2.5 015 28mm PT Yes - 9.54 2.56 016 38mm SL Yes - 13.41 4.97 017 28mm CT Yes - 2.37 3.23 018 24mm PT No 10.75 - - 019 20mm CT Yes - 3.5 3.28 020 45mm PT Yes - 10.69 2.32 021 24mm SL Yes - 47.59 5.81 022 24mm CT Yes - 3.43 2.78 023 20mm PT Yes - 4.07 3.93 024 45mm CT Yes - 4.03 2.45 025 38mm SL No 6.14 - - 026 38mm SL No 17.87 - - 027 28mm CT Yes - 3.53 3.19 028 24mm PT No Past 705 - - 029 20mm CT Yes - 3.1 2.53 030 45mm PT Yes - 6.97 7.07 031 24mm SL No 29.19 - - 032 24mm CT Yes - 8.58 2.25 033 20mm PT Yes - 6.87 2.75 034 45mm CT Yes - 3.31 2.63 035 28mm PT Yes - 3.63 5.94 036 24mm SL Yes - 22.97 4.22 037 24mm CT Yes - 4.66 5.63 038 20mm PT Yes - 6.68 3.91 039 45mm CT Yes - 3.75 3.15 040 28mm PT Yes - 5.22 2.28 Gray — Data Excluded (No match Pain or MMSE) 142 Table 36 - Raw data (cont'd) Subject Package Testrg # 9 Type Opened Abort Time (s) Time to open (8) Time to close (8) 041 38mm SL No 25.75 - - 042 28mm CT Yes - 5.54 4.22 043 24mm PT Yes - 5.63 3.79 044 20mm CT Yes - 2.38 2 045 45mm PT Yes - 15.09 3.12 046 24mm SL Yes - 9.1 3.19 047 24mm CT Yes - 5 2.41 048 20mm PT Yes - 7.31 1.63 049 45mm CT Yes - 7.85 3.5 050 28mm PT Yes - 4.28 3.88 051 38mm SL Yes - 24.28 5.04 052 28mm CT Yes - 3.65 3.1 053 24mm PT No 11.03 - - 054 20mm CT Yes - 4.97 5.19 055 45mm PT Yes - 7.66 3.54 056 24mm SL No 22.91 - - 057 24mm CT Yes - 4.6 4.06 058 20mm PT No 33.97 - - 059 45mm CT Yes - 3.4 1.97 060 28mm CT Yes - 5.78 4.59 061 45mm CT Yes - 2.15 2.37 062 28mm CT Yes - 9.71 6.88 063 x x x x X 064 24mm PT No 28.37 - - 065 20mm CT Yes - 3.31 5.28 066 45mm PT Yes - 2.09 3.71 067 24mm SL No 30.79 - - 068 20mm PT No 36.25 - - 069 20mm PT Yes - 44.78 4.75 070 45mm CT Yes - 2.5 1.91 071 x x x x X 072 28mm PT Yes - 2.87 2.25 073 38mm SL No 36.25 - — 074 28mm CT Yes - 2.56 2.06 075 24mm PT No 44.94 ' - - 076 20mm CT Yes - 4 3.34 077 45mm PT Yes - 6.03 3.16 078 24mm SL Yes - 4.5 4.59 079 24mm CT Yes - 2.47 2.44 080 20mm PT Yes - 10.43 3.38 Gray —— Data Excluded (No match, Pain or MMSE) 143 Table 36 — Raw data (cont'g Subject Package Testipg # 9 Type Opened Abort Time (s) Time to open (8) Time to close (8) 081 45mm CT Yes - 3.94 3.22 082 28mm PT Yes - 4.5 2.4 083 38mm SL Yes - 5.19 8.53 084 28mm CT Yes - 2.88 1.62 085 24mm PT Yes - 7.78 2.28 086 20mm CT Yes - 6.22 2 087 45mm PT Yes - 7.69 2.28 088 24mm SL Yes - 20.44 1.35 089 24mm CT Yes - 1.84 1.17 090 20mm PT No 36.37 - - O91 45mm CT Yes - 2.37 2.19 092 28mm PT Yes - 6.28 4.22 093 38mm SL No 6.18 - - 094 28mm CT Yes - 2.16 1.79 095 24mm PT No 29.03 - - 096 20mm CT Yes - 4.41 3.56 097 45mm PT Yes - 14.47 2.31 098 24mm SL Yes - 13.72 2.56 099 24mm CT Yes - 3.46 2.69 100 20mm PT Yes - 15.56 1.91 101 45mm CT Yes - 1.03 2.34 102 28mm PT No 24.85 — - 103 38mm SL Yes - 16.13 2.28 104 28mm CT Yes - 5.25 3.15 105 24mm PT Yes - 2.34 2.03 106 20mm CT Yes - 2.31 1.85 107 45mm PT Yes - 3.91 4.18 108 24mm SL Yes - 7.81 3.53 109 24mm CT Yes - 2.97 2.19 110 20mm PT Yes - 11.16 2.56 Gray — Data Excluded (No match, Pain or MMSE) 144 Table 36 - Raw data (cont'd) Subject PacQge Tesm # 10 Type Opened Abort Time (s) Time to open (5) Time to close (s) 001 45mm CT Yes - 2.69 2.34 002 20mm PT No 32.44 - - 003 20mm CT Yes - 4.34 3.1 004 24mm PT Yes - 36.5 3.9 005 24mm CT Yes - 5.75 2.96 006 24mm SL No 8.53 - - 007 24mm PT x x x X 008 20mm CT Yes - 6.47 4 009 45mm PT No 15.46 - - 010 24mm PT Yes - 21.44 7 01 1 24mm CT No 35.48 - - 012 20mm PT Yes - 8.19 2.41 013 45mmCT Yes - 3.71 1.78 014 28mm PT No 29.07 - - 015 38mm SL Yes — 13.94 2.95 016 28mm CT Yes - 2.98 2.19 017 24mmPT No 13.16 - - 018 20mm CT Yes - 4.54 2.84 019 45mm PT Yes - 6.75 9.43 020 24mm SL Yes - 20.81 2.57 021 24mm CT Yes — 19 8.1 022 20mm PT No 16.53 - - 023 45mm CT Yes - 3.68 2.78 024 28mm PT No 38.1 - - 025 28mm CT Yes - 2.91 2.89 026 28mm CT Yes - 4.35 4.31 027 24mm PT No 12.25 - - 028 20mm CT No 34.54 - - 029 45mm PT Yes - 17.81 2.28 030 24mm SL No 20 - - 031 24mm CT Yes - 2.94 3.75 032 20mm PT No 9.97 - - 033 45mm CT Yes - 2.28 3.15 034 28mm PT Yes - 9.35 2.51 035 38mm SL Yes - 16.72 3.25 036 24mm CT Yes - 5.22 3.78 037 20mm PT Yes - 15.07 3.38 038 45mm CT Yes - 2.44 2.78 039 28mm PT Yes - 8.1 3.43 040 38mm SL Yes - 13.81 5.65 Gray — Data Excluded (No match, Pain or MMSE) 145 Table 36 - Raw data @nt'd) Subject Package Testing # 10 Type Opened Abort Time (s) Time to open (5) Time to close (5) 04] 28mm CT No 17.05 - - 042 24mm PT No 1 1.31 - - 043 20mm CT Yes - 3.56 4.94 044 45mm PT Yes - 2.37 5.21 045 24mm SL No 25.47 — - 046 24mm CT Yes - 3.94 3.56 047 20mm PT Yes - 6.07 2.4 048 45mm CT Yes - 2.28 2 049 28mm PT Yes - 7.37 2.15 050 38mm SL Yes - 22.78 3.79 051 28mm CT Yes - 3.41 3.94 052 24mm PT No 14.53 - - 053 20mm CT Yes - 7.22 2.34 054 45mm PT Yes - 5.06 5.07 055 24mm SL Yes — 7.03 3.84 056 24mm CT Yes - 4.37 3 057 20mm PT No 35.28 - - 058 45mm CT Yes - 10.15 9 059 28mm PT Yes - 7.44 2 060 38mm SL No 5.72 - - 061 28mmCT Yes - 2.69 2.5 062 24mm PT Yes - 24.19 4.75 063 x x x x x 064 20mm CT Yes - 8 3.06 065 45mm PT Yes - 10.84 4.15 066 24mm SL No 7.62 - - 067 24mm CT Yes - 4.66 3.34 068 24mmCT Yes - 9. 37 2.81 069 45mm CT Yes - 3.78 2.5 070 28mm PT Yes - 24.75 6.84 071 x x x x x 072 38mm SL Yes - 32.28 3.91 073 28mm CT Yes - 2.62 1.75 074 24mm PT Yes - 19.6 2.53 075 20mm CT Yes - 3.02 2.15 076 45mm PT Yes - 5.5 2.9 077 24mm SL Yes - 14.53 2.53 078 24mm CT Yes — 4.13 3.53 079 20mm PT Yes - 12.67 2.32 080 45mm CT Yes - 1.28 2.5 Gray — Data Excluded (No match, Pain or MMSE) 146 Table 36 - Raw data (cont'd) Subject Package Testfl # 10 Type Opened Abort Time (s) Time to open (8) Time to close (8) 081 28mm PT Yes - 7.82 4.68 082 38mm SL Yes - 4.34 2.79 083 28mm CT Yes - 2.69 2.47 084 24mm PT Yes - 28.1 2 085 20mm CT Yes - 2.69 2.66 086 45mm PT Yes - 6.6 2 087 24mm SL Yes - 16.5 4.56 088 24mm CT Yes - 5.06 1.73 089 20mm PT Yes - 22.22 3.22 090 45mm CT Yes - 2.72 4.72 091 28mm PT No 7.65 - - 092 38mm SL No 8.22 - - 093 28mm CT Yes - 1.97 2.5 094 24mm PT Yes - 3.4 1.84 095 20mm CT Yes - 3.09 3.4 096 45mm PT Yes - 6.37 2.28 097 24mm SL Yes - 11.25 2.97 098 24mm CT Yes - 4.34 3.16 099 20mm PT Yes - 5.91 2.4 100 45mm CT Yes - 1.53 2.69 101 28mm PT Yes - 3.03 2 102 38mm SL No 16.16 - - 103 28mm CT Yes - 2.26 1.68 104 24mm PT Yes — 1 1.97 3.43 105 20mm CT Yes - 1.72 2.06 106 45mm PT No 17.09 - - 107 24mm SL Yes - 4.56 2.94 108 24mm CT Yes - 1.53 2.22 109 20mm PT Yes - 4.1 3.25 110 45mm CT Yes - 1.57 1.71 Gray — Data Excluded (No match, Pain or MMSE) 147 Functional Diameter Subject # Right 1-2 Right 1-3 Left 1-2 Gray — Data Excluded (No match, Pain or MMSE) 148 Functional Diameter Subject # Right 1-2 Right 1-3 Left 1-2 Left 1-3 074 075 077 43 079 43 Gray — Data Excluded (No match, Pain or MMSE) 149 Table 36 - Raw data (cont'd) Functional Grip Diameter (mm) sub’e“ # Right 1-2 Right 13 Left 1-2 Left 1-3 081 28 30 24 29 082 32 36 30 36 083 31 41 34 45 084 34 '40 32 42 085 21 21 35 44 086 35 4o 25 45 087 37 42 35 40 088 32 43 37 44 089 41 45 40 44 090 37 44 30 36 091 38 4o 33 40 092 33 41 36 40 093 32 40 38 43 094 36 44 36 43 095 33 41 36 43 096 36 43 33 42 097 44 50 43 47 098 37 44 37 45 099 41 44 44 47 100 29 3o 28 30 101 37 42 36 44 102 40 42 4o 45 103 33 37 35 38 104 35 41 35 44 105 33 37 36 42 106 38 41 36 42 107 38 47 36 43 108 34 41 38 43 109 43 45 43 48 110 40 43 40 45 Gray — Data Excluded (No match, Pain or MMSE) 150 Table 36 - Raw data (cont'd) Anthropometrics - Hand measurement (mm) Subject No. Age LH Palm LH Index RH Palm LH Index 1 88 90.95398 74.22897 93.85532 72.12676 2 87 88.18318 65.84007 89.85048 66.19392 3 82 84.56556 71.21376 83.60365 71.19514 4 80 109.8176 84.45291 110.1913 76.10018 5 86 91.82708 63.26656 97.08975 62.77398 6 76 89.09613 69.6145 90.95171 66.17615 7 85 86.58318 73.71867 91.45381 67.20286 8 84 87.76162 74.44422 88.03549 72.50076 9 93 86.83103 74.50532 89.82564 74.01331 10 65 95.62746 69.68969 94.31893 73.75667 11 68 89.80541 62.64572 86.51139 66.81732 12 71 92.94916 81.31173 93.60973 80.52372 13 77 81.21971 65.22879 81.87094 71.55987 14 84 87.86505 70.37606 86.10389 62.53596 15 88 91.94274 73.99108 91.71476 73.58085 16 87 81.1064 62.95969 89.53459 63.54529 17 79 93.89045 72.69726 95.85769 71.37961 18 77 85.17981 67.33125 82.77938 69.95802 19 74 83.77178 50.50294 99.69925 40.44754 20 75 104.4188 78.16002 112.4784 74.25967 21 72 84.29515 71.04383 0 0 22 82 87.608 65.87312 88.35296 67.72815 23 83 106.0359 86.32625 105.8529 84.63288 24 86 96.79024 66.751 1 94.7953 72.95412 25 8/ 90.17909 54.55266 90.9067 49.14527 26 77 97.39002 66.95524 100.9345 73.42117 27 76 87.42652 67.90748 90.30823 63.65699 28 81 81.33051 69.75716 85.83489 63.79708 29 91 86.91769 61.83475 89.10786 65.27806 30 85 81.25184 64.33327 86.38838 62.92819 31 85 88.23955 72.28352 90.42938 67.14944 32 70 86.6691 71.56361 87.09831 71.03489 33 72 93.01518 79.49621 95.71752 79.00916 34 79 87.94423 66.04546 90.38595 64.33077 35 80 96.30809 78.51655 94.42576 74.26183 36 70 85.51871 76.57663 90.35155 70.00148 37 64 87.11091 76.36025 87.75083 73.73505 38 60 84.05058 67.6674 85.07819 68.71355 39 69 92.93053 74.97628 97.32999 73.94306 40 80 92.29715 71.86316 90.18476 70.55592 Gray — Data Excluded (No match, Pain or MMSE) 151 Table 36 - Raw data (cont'd) Anthropometrics - Hand measurement (mm) Subject No. Age LH Palm LH Index RH Palm LH Index 41 70 83.61865 71.29364 81.51857 70.30235 42 78 84.21748 69.75367 85.31098 68.08072 43 78 92.92284 75.39522 91.431 77.43496 44 72 90.25327 73.62791 93.83435 69.59453 45 73 91.11179 82.72176 98.42855 77.30363 46 80 137.224 72.5193 103.878 70.76694 47 74 92.48225 79.00802 93.07216 77.0223 48 71 84.40919 73.49134 95.8216 74.64431 49 65 91.05354 68.81718 91.7841 66.51419 50 8/ 87.83613 72.79194 89.82529 70.19442 51 94 81.0147 70.03331 85.64136 72.32097 52 92 88.98844 69.45195 91.90595 69.34782 53 84 84.37895 63.16975 88.59257 62.42 54 74 93.95742 83.94431 94.31776 80.55245 55 75 92.92238 78.72185 98.49178 76.48869 56 78 85.37599 70.42155 88.22918 71.99675 57 64 94.15655 77.13293 94.91964 73.12685 58 97 88.51955 68.6645 99.28212 61.5294 59 75 89.85432 73.08559 89.1245 74.95514 60 65 82.88256 65.55942 86.14819 67.72873 61 84 106.7393 84.97269 103.986 76.79683 62 88 97.83459 81.05418 99.80825 77.36309 63 87 0 0 0 0 64 89 86.76024 62.69439 86.0185 70.56141 65 7/ 86.1873 70.23996 87.18043 72.00199 66 85 92.01803 75.4063 95.95316 69.74101 67 82 98.03688 71.98773 96.02188 72.38525 68 87 82.70587 70.25705 83.21916 67.8809 69 85 94.97944 70.61305 94.10889 70.62611 70 77 96.92669 72.21218 96.6271 69.0089 71 75 0 0 0 0 72 73 85.10774 71.071 1 89.47247 68.29054 73 79 93.67736 80.46603 95.94667 79.61708 74 69 89.19461 83.70114 91.96291 78.89958 75 81 79.57036 64.5179 80.63693 65.42475 76 89 86.7079 80.46606 88.83815 74.7402 77 70 82.44789 72.63682 86.05261 71.05605 78 7/ 102.5483 83.72097 103.8708 84.10979 79 79 103.7757 80.01631 103.4978 78.7947 80 71 88.35971 68.90517 90.21492 66.159 Gray — Data Excluded (No match, Pain or MMSE) Table 36 - Raw data (cont'd) Anthropometrics - Hand measurement (mm) Subject No. Age LH Palm LH Index RH Palm LH Index 81 82 80.26562 60.64931 84.44224 60.57799 82 63 89.90462 67.51585 88.92467 66.24366 83 70 95.85036 76.48086 97.23984 74.36392 84 68 85.68759 69.9762 86.20593 69.40945 85 68 96.93002 73.86654 94.93298 29.0901 86 7 / 104.0754 82.47692 107.1193 70.22998 87 65 84.72907 77.01 137 91.4874 74.2091 88 74 89.23496 74.84072 90.05155 71.99962 89 78 88.09793 76.60131 93.93811 75.44825 90 86 98.50576 73.92778 97.55401 72.28821 91 60 84.66437 75.46506 86.96513 70.07287 92 64 91.59593 78.22589 93.96185 77.92862 93 72 85.02594 74.09002 85.34849 75.89023 94 81 89.25641 68.25225 90.44241 69.08281 95 68 84.08181 71.64073 84.64023 68.0986 96 76 96.55328 78.16733 97.97369 77.76212 97 79 101.9345 82.95343 105.6545 86.41653 98 69 105.8113 79.04928 103.2819 77.94389 99 61 88.35296 73.21216 92.51234 71.96291 100 82 85.06405 63.56824 86.08163 68.37549 101 74 85.47516 67.27523 86.35884 68.11169 102 84 88.81572 76.99749 89.42659 74.61989 103 77 85.75148 70.36316 90.95701 68.95031 104 85 87.4578 70.62831 93.94982 68.46081 105 7] 105.8544 78.49636 106.7637 77.38162 106 85 76.89952 67.93501 81.60408 65.9968 107 66 86.91967 82.07891 90.94799 83.1485 108 65 93.714 72.47288 94.48906 72.48761 109 64 92.61907 77.49264 94.93488 75.39838 110 74 86.94724 73.16941 90.16586 76.63587 Gray — Data Excluded (No match, Pain or MMSE) 153 Appendix H — Statistical Analysis: Model 2 Split-Plot Design - Model 2 (Time to open) A split-plot design was employed that included covariate variables (those related to the strength data that was collected) was also conducted using the data from the 100 usable subjects. The second split plot design treated time to open as the response variable (dependent variable) and the following factors as fixed effects: Diagnosis (See Table 4- only two levels were considered: arthritis vs. control) Type (the 10 types of packages- See Table 3 and Figure 26) Diagnosis x Type Gender (male vs. female- See Table 4) Type x Gender Diagnosis x Gender Grip strength of the right hand (covariate variable- See Table 7) Grip strength of the left hand (covariate variable— See Table 7) Wrist strength of the right hand (covariate variable-See Table 7) Wrist strength of the left hand (covariate variable-See Table 7) Palm strength (covariate variable- See Table 7) Grip diameter of the right hand between the first and second digit (covariate variable) Grip diameter of the right hand between the first and third digit (covariate variable) Grip diameter of the left hand between the first and second digit (covariate variable) 154 0 Grip diameter of the left hand between the first and third digit (covariate variable) See Table 37 for the results, obtained using SAS Proc Glimmix. Table 37 - Results of Split Plot- Model 2- Resultant Variable is Time to Open- All Effects are considered Fixed Effects Effect Num DF Den DF F Value Pr>F Diagnosis 1 ’ 78.1 1.03 0.3143 Type 9 647 46.50 <.0001 Diagnosis x Type 9 655 1.48 0.1520 Gender 1 79.4 2.06 0.1547 Type x Gender 9 647 1.21 0.2858 D‘agms‘s x 1 77.2 0.13 0.7207 Gender Grip Strength Right 1 84.5 0.82 0.3675 6“” Strength 1 82.5 0.27 0.6077 Left Wrist Strength Right 1 83.5 2.07 0.1539 wm‘ Strength 1 82.5 1.21 0.2744 Left Palm to palm 1 84.4 1.76 0.1883 squeeze Grip diameter right 15‘ and 2nd 1 96.8 2.15 0.1457 digit Grip diameter right 15‘ and 3rd 1 124 1.01 0.3170 digit Grip diameter left 15‘ and 2nd digit 1 89.8 0.10 0.7555 Grip diameter left 1,, and 3rd digit 1 96.7 0.86 0.3549 Bolded Effects were indicated to be significant at a level of 0.01. 155 The effect of design (P&T, SL and CT), size (20, 24, 28, 38 and 45) and shape (square and round) on the time to Open (using model 2) was also considered. (See Table 38). Table 38 - Model 2- Analysis of VaryinLEffects on Time to 0 en Effect Estimate Standard DF t Value Pr > [11 Enor N on-CR CT vs. CR -1.0135 0.05349 649 -18.95 <0.0001 designs Round VS' 0.01241 0.05399 647 0.23 0.8183 Square CT vs. P&T -0.9011 0.05884 649 -1531 <0.0001 P&T vs. SL 03314 0.07294 648 .454 <0.0001 CT vs. SL 4.2324 0.07207 649 -17.10 <0.0001 5‘26 20mm 07169 1.2814 647 -1.71 0.0873 vs. 24 mm Size 20mm vs. 24 0.08508 0.08436 647 1.01 0.3136 (round only) 5'" 20mm 0.3175 0.08366 647 3.80 0.0002 vs. 28 mm 5'" 20““ -0.5872 0.1031 647 -5.70 <0.0001 vs. 38 mm 5'" 20'“ 0.4410 0.08346 647 5.28 <0.0001 vs. 45mm 5'" 24“” 0.4500 0.07536 646 5.97 <0-0001 28mm 5"“ 24““ -0.4548 0.09645 647 -4.72 <0.0001 vs. 38mm 5'19 24mm 0.5735 0.07513 647 7.63 <0.0001 vs. 45mm 5‘" 28““ -0.9048 0.1016 647 -8.91 <0.0001 vs.38mm 5'" 28'“ 0.3827 0.08196 646 4.67 <0.0001 vs. 45mm 3'“ 38”“ 1.0283 0.1014 647 10.14 <0.0001 vs.45mm 156 The model 2 analyses were repeated for time to close with the following result (See Table 39). Table 39 - Results of Split Plot-Model 2- Resultant Variable is Time to Close- All Effects are considered Fixed Effects Effect Num DF Den DF F Value Pr>F Diagnosis 1 70.8 0.09 0.7642 Type 9 640 7.20 <0.0001 D‘ag’ws‘s X 9 649 0.93 0.5016 Type Gender 1 72.2 0.09 0.7589 Type x Gender 9 640 0.99 0.4441 D‘agnos‘s x 1 70 2.68 0.1060 Gender Grip Strength Right 1 77 0.26 0.6105 an Strength 1 75.1 0.08 0.7846 Left wr‘S‘ Strength 1 76 0.03 0.8646 Right WW Strength 1 75.1 0.1 1 0.7383 Left Palm 1° palm 1 76.8 1.70 0.1961 squeeze Grip diameter right 1st and 1 88.5 0.38 0.5388 2nd digit Grip diameter right 1st and 1 115 0.58 0.4496 3rd digit Grip diameter left 1st and 2"“I 1 82.1 1.85 0.1773 digit Grip diameter left 1st and 3rd 1 88.7 1.48 0.2274 digit No overall effects (except for type) were found to be significant at a level of or = 0.01 regarding the time that it took for participants to close the varying containers when model 2 was employed in the data analysis. This is a somewhat expected result, as people that were unable to open a package of a given type were not asked to attempt to re-secure 157 the closure. included in this analysis. As a result, people that were having significantly difficulties were not Table 40 - Model 2-Ana1ysis of Varying Effects on Time to Close Effect Estimate Standard DF t Value Pr > M Enor Non-CR CT ' vs. CR -0.2697 0.0450 642 -6.66 <0.0001 designs 1‘0“" VS' -0.1208 0.04088 640 -2.95 0.0032 Square CT vs. P&T -0.2064 0.04455 642 -4.63 <0.0001 P&T vs. SL -0.1961 0.05522 640 -3.55 0.0004 CT vs. SL -0.4025 0.05456 642 -7.38 <0.0001 3‘26 20mm -01243 0.05857 640 -2.12 0.0342 vs. 24 mm Size 20mm vs. 24 0.04703 0.06387 639 -0.74 0.4619 (round only) 5‘23 20mm 0.007646 0.06334 639 —0.12 0.9040 vs. 28 mm 5'“ 20”” -O.3956 0.07806 640 -5.07 <0.0001 vs. 38 mm 5‘23 20mm 01031 0.06319 640 -1.63 0.1031 vs. 45mm 5‘78 24mm 0.1319 0.05706 639 2.31 0.0211 28mm 3126 24mm 02713 0.07302 639 -3.72 0.0002 vs. 38mm 5‘26 24mm -0.02116 0.05688 640 0.37 0.7100 vs. 45mm 3‘26 28mm -04033 0.07692 639 -524 <0.0001 vs.38mm 3‘26 28mm 0.02240 0.06206 639 -0.36 97182 vs. 45mm 3'” 38”” 0.2925 0.07680 640 3.81 09002 vs.45mm Effects that are significant at a level of 0.01 are bolded. 158 All analyses were repeated using the attribute data (package successfully opened-- yes or no) with the following results (see Tables 41 and 42): Table 41 - Results of Split Plot- Resultant Variable is Package Successfully Open- All Effects are considered Fixed Effects Effect Num DF Den DF F Value Pr>F Diagnosis 1 64.71 3.99 0.0499 Type 9 964 16.02 <0.0001 Gender 1 207.7 0.52 0.4736 6” Strength 1 67.88 2.55 0.1146 nght 0“" Strength 1 68.01 0.03 0.8688 Left Wrist Strength Right 1 66.96 4.46 0.0384 wr's‘ Strength 1 71.61 7.11 0.0095 Left Palm t" 93"“ 1 83.7 13.16 0.0005 squeeze Grip diameter right 1st and 2nd 1 63.71 0.17 0.6814 digit Grip diameter right 1st and 3rd 1 57.85 1.70 0.1968 digit Grip diameter left 15‘ and 2nd digit 1 63.25 0.47 0.4972 Grip diameter left 1.. and 3... digit 1 61.16 1.12 0.2932 159 Table 42 - Analysis of Varyig Effects on Package Successfully Open Effect Estimate Standard DF t Value Pr > M Error Non-CR CT vs. CR -0.2697 0.4160 964 -8.95 <0.0001 designs 1‘0““ VS' -0.1208 0.3088 964 3.68 00002 Square CT vs. P&T -0.2064 0.4236 964 -8.25 <0.0001 P&T vs. SL -0.1961 0.2635 964 -233 0.0201 CT vs. SL -0.4025 0.4540 964 -9.05 <0.0001 5‘26 20mm 01243 0.3207 964 -0.44 09573 vs. 24 mm Size 20mm vs. 24 (round 004703 0.3714 964 -1.13 0.2594 only) 5‘" 20“” 0.007646 0.6284 964 -3.85 00001 vs. 28 mm 3‘26 20mm -0.3956 0.3833 964 -190 0.0573 vs. 38 mm 5'“ 20mm 01031 0.4751 964 5.64 <0.0001 vs. 45mm 5'“ 24mm 0.1319 0.6166 964 4.15 <0-0001 28mm 5‘26 24mm 02713 0.3615 964 -1.62 0.1046 vs. 38mm 5'“ 24mm -0.02116 0.4612 964 6.12 <0.0001 vs. 45mm Sm 28“” -0.4033 0.6556 964 -4-80 <0-0001 vs.38mm 3126 28”“ 002240 0.6882 964 1.33 0.1838 vs. 45mm 5'" 38mm 0.2925 0.5140 964 6.63 <0.0001 vs.45mm Effects that are significant at a level of 0.01 are bolded. 160 10. ll. 12. 13. 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