\full ,3»: I! , villi. ”NJ. “1...: A. U3: ., . 7?... to. 3 A, :3: 5a... .6... 4B 39.: ..f. rrnwu-1.a.......§.hfi..u|.l ‘ .mrnianfi ‘ :fifitfi . 13:4 ‘5‘: 5:. s‘i‘ f3 z: THESIS Date lllllllflllllllllUIWWIJHIIHIIHWill!!!”HIHIIWI 302050 9935 This is to certify that the thesis entitled Evaluation of Non—Response Bias in a Study of Great Lakes Sport Fish Consumption and Conception Failure presented by Eugene Michael Tay has been accepted towards fulfillment of the requirements for Master's Epidemiology degree in W Major professor February 15, 2000 0-7 639 MS U is an Affirmative Action/Equal Opportunity Institution 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 ‘ c“. C'. Hi 6 Kb 13 A ‘1: V [k A‘ ‘rl~] t) [l [U I.) 04 woo chlRC/DdoDuopGS-pfl T" EVALUATION OF NON-RESPONSE BIAS IN A STUDY OF GREAT LAKES SPORT FISH CONSUMPTION AND CONCEPTION FAILURE By Eugene Michael Tay A THESIS Submitted to Michigan State University in partial fulfillment of the requirements for the degree of MASTER OF SCIENCE Department of Epidemiology 2000 ABSTRACT EVALUATION OF NON-RESPONSE BIAS IN A STUDY OF GREAT LAKES SPORT FISH CONSUMPTION AND CONCEPTION FAILURE By Eugene Michael Tay Research previously conducted by Courval et a1.1 has suggested a modest association in men of Great Lakes sport fish consumption with risk of conception delay. However, a low response rate raised concerns about non-response bias as an explanation for these findings. This study was performed to evaluate whether non-response bias could have occurred. Telephone interviews were conducted with 230 men and 38 women who did not respond to the original survey. Non-responders were compared to the original responders on key demographic, behavioral, and reproductive characteristics. Non-responders were approximately 1.5 years older at interview, were more likely to be Caucasian, and reported higher incomes than responders. No differences were found with respect to education level, marital status, or smoking. Non-responders fished fewer days in the past year and consumed fewer fish meals than responders. Compared with responders, non-responders were more likely to have had two or more children and were less likely to intend to have additional children within the next five years. However, among both non-responders and responders there was an increased prevalence of a period of conception failure among men who reported consuming greater quantities of Great Lakes sport fish. These results suggest that non-response bias is unlikely to have played a major role in the observed association of sport fish consumption and conception delay. l Courval JM, DeHoog JV, Stein AD, Tay EM, He JP, Humphrey HEB, Paneth N. Sport-caught fish consumption and conception failure in licensed Michigan anglers. Environ Res 1999;80:8183-8188. To DAVID CAMERON whose impending birth finally motivated me to finish this thesis essay To LAURA JANE who had to endure six years of “Don’t worry — I’m going to finish my thesis” iii ACKNOWLEDGMENTS I would first like to acknowledge Dr. Jeanne Courval and Dr. Aryeh Stein. Dr. Courval and Dr. Stein were instrumental in involving me with the Fisheaters Family Health Project and provided much guidance in the development, execution, and data analysis of this project. I would also like to acknowledge the role of my committee members, Dr. Nigel Paneth, Dr. Joseph Gardiner, and Dr. Lynda Farquhar, who provided meaningful feedback and constructive comments on this thesis essay. Finally, I would like to acknowledge the Environmental Protection Agency, which supported me and this research under a Science to Achieve Results (STAR) Graduate Student Fellowship Award. iv TABLE OF CONTENTS LIST OF TABLES .......................................................................................................... vii LIST OF FIGURES ......................................................................................................... ix LIST OF ABBREVIATIONS ............................................................................................ x INTRODUCTION ............................................................................................................. 1 CHAPTER 1 BACKGROUND ............................................................................................................... 3 Polychlorinated biphenyls ...................................................................................... 3 Toxicity of polychlorinated biphenyls ................................................................... 4 Reproductive toxicity of polychlorinated biphenyls in humans ............................ 6 The F isheaters Family Health Project .................................................................... 6 CHAPTER 2 NON-RESPONSE BIAS ................................................................................................... 9 The postal survey ................................................................................................... 9 Limitations of postal surveys ............................................................................... 10 Handling non-response ........................................................................................ 12 Non-response bias in social science literature ..................................................... l4 Non-response bias in epidemiological and health sciences literature .................. 17 CHAPTER 3 METHODS ...................................................................................................................... 33 Population and setting .......................................................................................... 33 Sampling .............................................................................................................. 35 Identification of telephone numbers .................................................................... 35 Interview .............................................................................................................. 36 Data entry ............................................................................................................. 37 Statistical methods ............................................................................................... 38 CHAPTER 4 RESULTS ........................................................................................................................ 40 Demographic characteristics of men .................................................................... 43 Behavioral characteristics of men ........................................................................ 48 Demographic and behavioral characteristics of women ...................................... 48 Fishing habits and fish consumption ................................................................... SO Reproductive characteristics ................................................................................ 54 Logistic regression analyses ................................................................................ 57 CHAPTER 5 DISCUSSION .................................................................................................................. 59 APPENDIX A TELEPHONE CALLING RULES OF REPLACEMENT .............................................. 66 APPENDIX B QUESTIONNAIRE ......................................................................................................... 68 APPENDIX C QUESTIONNAIRE SCRIPT AND LOG SHEET .......................................................... 71 REFERENCES ................................................................................................................ 73 vi TABLE 1: TABLEZ: TABLE 3: TABLE 4: TABLE 5: TABLE 6: TABLE 7: TABLE8: TABLE 9: TABLE 10: TABLE 1 1: LIST OF TABLES Responses to three mailings in a postal survey of North Carolina peach growers, 1946 ................................................................................... 14 Summary socio-demographic variables and their relationship with response status ............................................................................................ 16 Age-adjusted death rates for responders and non-responders for the first five years of the F ramingharn study, 1953-57 ..................................... l7 Age-adjusted comparisons of responders and non-responders to responses on health status in a population-based study of cardiovascular disease ................................................................................. 18 Comparison of baseline characteristics of non-responders and responders to a mailed follow-up survey of 15,440 persons who attended a preventive medicine center in Dallas, Tx at least once from 1972-81 .............................................................................................. 21 Summary of studies of non-response bias in the epidemiological and health sciences literature ............................................................................. 23 Participation status in a survey of Michigan licensed anglers, by gender and region ........................................................................................ 41 Demographic, socio-economic, and behavioral characteristics among male non-responders and responders to a survey of Michigan licensed anglers ............. 45 Demographic, socio-economic, and behavioral characteristics among male non-responders and responders to a survey of Michigan licensed anglers, by geographic region ....................................................... 46 Demographic, socio-economic, and behavioral characteristics among female non-responders and responders to a survey of Michigan licensed anglers ........................................................................................... 49 Fishing habits and sport-caught Great Lakes fish consumption in past year among non-responders and responders to a survey of Michigan licensed anglers, by sex ............................................................................... 52 vii TABLE 12: Fishing habits and sport-caught Great Lakes fish consumption in past year among male non-responders and responders to a survey of Michigan licensed anglers, by geographic region ....................................... 53 TABLE 13: Reproductive history among non-responders and responders to a survey of Michigan licensed anglers ........................................................... 55 TABLE 14: Reproductive history among non-responders and responders to a survey of Michigan licensed anglers, by geographic region ....................... 56 TABLE 15: Associations between sport-caught Great Lakes fish consumption and prevalence of a period of conception failure among male responders and non-responders to a survey of Michigan licensed anglers ........................ . ................................................................................ 58 viii LIST OF FIGURES FIGURE 1: Basic structure of polychlorinated biphenyls ................................................. 3 FIGURE 2: Target counties for the Fisheaters Family Health Project, Michigan ........... 34 FIGURE 3: Tracking flowchart of study participants ...................................................... 42 ix LIST OF ABBREVIATIONS PCB ............................................................................................. Polychlorinated biphenyl FFHP ............................................................................... Fisheaters Family Health Project INTRODUCTION FISHING in the State of Michigan is big business. An estimated two million Michigan anglers along with 334,000 nonresident tourists fish Michigan waters annually. Collectively they contribute close to $1.4 billion to Michigan’s economy in pursuit of sport-fishing (1). Not only is fishing a great recreational activity for some, but eating Great Lakes sport fish is a healthy choice as well. Fish are a highly nutritious food - they are a good source of protein and are low in saturated fat, and they contain many valuable vitamins and minerals. Certain sport fish contain omega-3 polyunsaturated fatty acids, which can lower triglyceride and cholesterol levels in the blood (2, 3). Eating fish regularly can reduce mildly elevated blood pressure and prevent hardening of the arteries as well as heart disease (2, 4). These benefits, however, are not without some potential drawbacks. Studies beginning in the early 1980’s suggested potential developmental delay in children of sport fish-eating mothers (5-9). The concern has been about the chemicals found in sport fish of the Great Lakes basin. Organochlorine compounds such as polychlorinated biphenyls, or PCBs, do not degrade quickly or easily in the environment. Despite the banning of PCBs from production in 1976, it is estimated that only about five percent of the 3.4 billion pounds of PCBs made worldwide have been destroyed or degraded (10). Furthermore, PCBs accumulate in the fatty tissues of fish over their lifetimes in a process known as bioaccumulation. The resulting concentration of PCBs in fish can be millions of times greater than the concentration of the chemicals in the water in which they live. In the Great Lakes region, consumption of contaminated fish has been identified as an important exposure route (11). Because of these potential concerns, Michigan’s fish advisory program was implemented in the 1970’s and is updated annually. Women of child-bearing age and children under age 15 are advised to limit their intake or avoid certain types of sport fish altogether, depending on the species and size of fish and the location at which the fish were caught (12). Recently, more intensive efforts at characterizing the potential health effects of sport fish on humans have been made. An emerging area of research has focused on the effect of sport fish consumption on reproductive and endocrine function. The Fisheaters Family Health Project at Michigan State University was established to pursue this research initiative. Research conducted by Courval et al. (13) has suggested a modest association, in men only, of Great Lakes sport fish consumption with risk of conception delay. However, these results were not without their limitations. A low response rate in that study raised concerns about the validity of these findings. Responders may have differed from non-responders, and this difference, termed non-response bias (14), may have been a factor in the observed results. Therefore, the present study was conducted to evaluate whether non-response bias could explain these findings. The results of the present study are presented hereinafter and have also been published in the academic literature (15). CHAPTER 1 BACKGROUND Polychlorinated biphenyls Polychlorinated biphenyls (PCBs) are a group of manufactured organic chemicals comprised of two covalently bonded benzene rings with chlorine substitution at any of the remaining carbons (Figure 1). They have the empirical formula of C,2H,o,,,Cl,,, where n=1-10. However, due to steric hindrance and electrostatic factors, generally only four to eight of the available carbon atoms are chlorinated at one time. There are 209 possible PCB compounds, called congeners. meta- ortho- 3’ 2' 2 3 para. 4. O O 4 6' 6' 6 6 meta- ortho- Figure 1: Basic structure of polychlorinated biphenyls. PCBs were first synthesized in 1881 and manufactured commercially from 1929 until 1977 in the United States by the Monsanto Chemical Company, under the trade name Aroclor. Aroclors were designated by four digit numbers. The first two digits specify the number of carbon atoms in the biphenyl group (with the exception of Aroclor 1016), while the last two digits indicate the approximate percentage of chlorine content by weight in the compound, e.g., Aroclor 1254 contains 54% chlorine content by weight. Commercial mixtures generally contained between 20 and 60 percent chlorine content by weight. The amount of chlorination confers different chemical and physical properties to individual congeners. In general, however, PCBs are lipophilic and hydrophobic, resistant to acids, bases, and oxidation/reduction reactions, nonflarnmable, nonconducting, and heat-resistant. These properties made them well-suited to a variety of industrial applications, such as insulators in transformers and capacitors, lubricants and hydraulic fluids, plasticizers, as flame retardants, and in pesticides, paints, sealants, glues, and carbonless copy paper. Unfortunately, these very properties that made PCBs ideal in industrial applications create problems for the environment. Their resistance to degradation causes PCBs to persist in the environment. Furthermore, their lipophilic nature causes PCBs to bioaccumulate in the food chain, with the amount of toxic chemicals increasing with each link up the food chain, a process known as biomagnification. Toxicity of polychlorinated biphenyls The toxicity of PCBs, like their chemical and physical properties, is a function of the structure of the individual congener, which in turn depends on its amount of chlorination. Individual congeners can assume a coplanar or non-planar conformation depending on the amount and position of the chlorine substitution. Chlorine atoms can be substituted at the ortho, meta, or para positions (Figure 1). Safe (16) summarized that those congeners that assume a coplanar conformation, namely 3,3’,4,4’-tetraCB, 3,3’,4,4’,5-pentaCB, and 3,3’,4,4’,5,5’-hexaCB, are approximate stereoisomers of 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) and elicit many of their toxicological effects through the same mechanism, hypothesized to be through the binding of the PCB compound to the Ah receptor to induce hepatic micosomal enzymes. The toxicity of such PCBs can be expressed in terms of TCDD- equivalency factors (TEFs), which is the potency of a particular congener to elicit a toxic effect relative to the potency of TCDD. In addition, there has been increasing focus on the toxic effects of non-coplanar, ortho substituted congeners that elicit their toxicity via unknown mechanisms (17). Toxic responses to PCBs have been demonstrated in laboratory animals, observations in wildlife, and epidemiologic studies in humans. The literature on PCB toxicology is extraordinarily vast and many reviews have been published (16, 18-27). In humans, toxicity as a result of PCB exposure came to prominence in 1968 when over 1,300 persons in Japan became ill from eating PCB-contaminated rice oil, in an incident later coined “Yosho” (28). A similar accidental poisoning occurred in Taiwan in 1979, called “Yu-cheng” (29). Consumption of PCB-contarninated rice oil resulted in a severe form of acne called chloracne and hyperpigrnentation of the skin, as well as fatigue, nausea, and liver disorders (30). Since then, researchers have studied the possible toxic effects of PCBs, which may include carcinogenicity (31-38), as well as hepatic (20, 32), derrnatologic (32, 39- 41), immune (42, 43), pulmonary (44), neurologic (45-48), developmental (5, 7, 8, 41, 48-54), endocrine (55), and reproductive (5, 41, 56-60) dysfunction. Reproductive toxicity of polychlorinated biphenyls in humans In several studies of reproductive toxicity of PCBs, women exposed to PCBs prenatally or occupationally gave birth to children who were slightly lighter in weight than those born to women less exposed (5, 56, 57), although this finding has not been consistently found (61, 62). In addition, women with higher serum PCB levels were more likely to have miscarriages than the general population (58), although these results may be confounded (63). More recently, women who ate more than one sport fish meal per month from Lake Ontario had shorter menstrual cycles compared to women who did not eat fish and a slight conception delay, although the latter finding was not statistically significant (59, 60). In men, Bush et a1. (64) found that the concentration of certain PCB congeners was inversely correlated with sperm motility index. Other studies (65, 66) which have reported a decline in semen quality and sperm count have heightened concern about possible reproductive effects of organochlorine compounds. The F isheaters Family Health Project The Fisheaters Family Health Project (FFHP) at Michigan State University was established in order to further our understanding of the exposure to and potential adverse human health effects from environmental PCB exposure. Finding a suitable population to study these effects, however, can prove challenging. Few large populations are chronically exposed to detectable levels of PCBs. One group of individuals potentially at riSk of PCB exposure is anglers of the Great Lakes who consume their catch. Consumption of contaminated fish from the waters of the Great Lakes has been identified as an important exposure route (11). For the FFHP, a postal questionnaire was developed to survey anglers and their partners about their demographic characteristics, behavioral and fish consumption habits, and reproductive histories (67). A source population of licensed anglers was selected from ten Michigan counties with Great Lakes shorelines. These anglers were identified using fishing license data obtained from the Michigan Department of Natural Resources. Surveys were mailed to 4,931 reproductive-age male and female licensed anglers aged 18-34 years between 1993 and 1995. Five hundred and five questionnaires were returned as undelivered; of the anglers who were presumed to have received the screening survey, 1,445 returned the questionnaire, giving an actual response rate of 1,445/(4,931-505) = 33%. Questionnaires were also received from 840 of their partners. Data obtained from the original F FHP screening survey suggested a modest association, in men only, of Great Lakes sport fish consumption with risk of conception delay (13). However, these results were not without their limitations, as the low response rate and the simultaneous ascertainment of exposure and outcome raised concerns about bias as possible explanations for these findings. In order to address some of these limitations, a prospective study was developed. From the previous postal survey, 375 couples and 1,030 individuals who were consumers of Great Lakes sport fish and who planned to have children in the near future were identified. These individuals were most suitable for a prospective study of reproduction and/or correlates of infertility in relation to PCB exposure. The methods and current progress of this prospective study have been described (68). Furthermore, a study of potential non-response bias was also undertaken, the results of which are presented hereinafter and have also been published in the academic literature (15). CHAPTER 2 NON-RESPONSE BIAS The postal survey The postal survey is a valuable epidemiological research tool. One of the primary reasons for its high prevalence in epidemiological research today is its cost and time effectiveness. Personal and telephone interviews demand significant time and human and financial resources. Multiple telephone calls are often required in order to contact individuals for interviewing or for setting up appointments for personal interviews. Personal interviews have the added cost of transportation of the interviewer to the interview site. If multiple interviewers are used, interviewer variability can become a concern. In contrast, postal surveys do not require an interviewer and can be done with bulk mailings. Thus, data can be procured quicker, cheaper, and more abundantly with a postal survey. Questionnaires can be mailed to eligible participants, filled out at home at the participants’ convenience, and returned by mail. In addition, postal surveys tend to be more valid than personal or telephone interviews because they enable respondents to check information by verifying their records or consulting with other members of the family, and because they permit more leisurely and thoughtful reply (69). Also, they often elicit responses fi'om people too busy for personal interviews and avoids interviewer or respondent bias for topics that are potentially embarrassing in a personal interview situation (70). Enrollment of subjects into a prospective epidemiologic study, such as the one carried out by us for the Fisheaters Family Health Project (67), is often accomplished using such a self-administered questionnaire. Limitations of postal surveys Postal surveys, however, are not without their concerns. In the present society, an endless onslaught of bulk mailings and solicitations deluge individuals and make them reluctant to respond or even open before discarding. F urthennore, the rising prevalence of surveys, including those in the health professions field, may have created a “survey fatigue” in the population (71). The majority of Americans have participated in at least one survey and a substantial proportion are asked to do so again each year (72). In many cases, the experience of being a survey participant is a negative one, leading to an increased disinclination to participate in future surveys (73). Taken together, these factors have made it difficult to achieve high response rates. Indeed, response rates since the 1950’s have decreased markedly. Steeh (74) found that refusal rates in two ongoing trend surveys carried out by a major university survey research center increased from only 6-8 percent in the 1950’s to 15-20 percent by the end of the 1970’s. Refusal rates in one of these surveys that has continued to the present have leveled off in recent years at 18-20 percent (75). Other authors have found refusal rates as high as 30 percent in major academic surveys (73) and even higher in commercial surveys (76). Increasing concerns about privacy and confidentiality and how the data will be used are primary reasons why some individuals choose not to participate (77). Some authors have speculated that the decline in participation rates can be 10 attributed to a decline in people’s sense of social responsibility and less belief in the legitimacy of social institutions (78). This high refusal rate, or non-response, is a major limitation of survey research and can seriously challenge the external validity of survey results. Bias can occur when those who do not respond to a survey (the “non-responders”) differ from those who do (the “responders”). This bias is termed “non-response bias” (14). When non-response bias occurs, the study population may not be representative of the total survey population. Results drawn from studies of this study population are not necessarily generalizable to the entire group invited to participate and incorrect conclusions may be drawn. Response that is correlated with exposure levels and disease outcome may artificially increase or decrease measures of association in cross-sectional, case-control, and cohort studies (79- 83). Non-response bias is most likely to occur when response rates are low. In this situation, survey estimates will become biased the more non-responders differ from responders. A low response rate, however, does not necessarin indicate that survey estimates are biased by non-response. When responders and non-responders do not differ, the response rate will have no effect on prevalence estimates. Conversely, high response rates does not necessarily protect against non-response bias, as this bias can still be important if the few remaining non-responders differ markedly from responders. For example, in a postal survey of almost 2,500 economically active and capably employable disabled persons, Sheikh and Mattingly (84) obtained an 84% response rate; nevertheless, non-responders were significantly different from responders with respect to employment status and training. Regardless, it has been suggested that in order to best minimize the 11 potential for non-response bias, response rates of at least 80 percent should be achieved (14, 85). Handling non-response There are multiple ways of dealing with non-response. Ideally, the best strategy to limit non-response bias is to maximize response rates. Several reviews and meta- analyses have been published (86-89), and the success of individual methods has been reported (69, 70, 90-101). These methods involve efforts revolving around the timing and techniques of survey administration. Some of the important factors include financial incentives, follow-ups, preliminary notification, questionnaire characteristics (length, color, subject matter), cover letter characteristics (length, type of appeal, format, status of signer), sponsoring institution, deadlines, time of posting, type and amount of outgoing and retum postage, and respondent anonymity (102, 103). However, the particular details behind these methods are beyond the scope of this discussion. For the Fisheaters Family Health Project, several of these methods were employed to boost the response rate (67). Given that increasing response rates often proves challenging, other strategies have been advocated in order to detect a possible bias. Most commonly, information is collected on a sample of non-responders. Non-responders can be contacted by telephone or in person and persuaded to complete a full or shortened survey. Then, a simple comparison of characteristics and responses of responders and non-responders can be made to determine if and how non-responders differ from the responders. However, it should be noted that similarity between responders and non-responders with regard to certain characteristics does not necessarily imply similarity with regard to exposure and 12 disease status, and the exact influence of any bias on survey variables cannot easily be determined. Another strategy for detecting a possible bias is to compare the responses of “early” responders, or those who respond before a follow-up letter is sent, versus “late” responders, or those who respond after a follow-up letter is sent, to see if there are any trends operating. The assumption of this strategy is that responders are ordered on a continuum, and that non-responders are simply “super-late” responders. Considerable differences have often (104), but not always (105), been found between early and late respondents. A final strategy for detecting a possible bias is to compare responders and non- responders on characteristics for which complete data are available, such as in the case of studies of veterans using military records. Seltzer et al. (106) was able to use military records in a postal questionnaire of smoking habits of US. veterans and found that only 67% of smokers returned their questionnaire within 30 days, in contrast to 85% of non- smokers. If a significant difference between responders and non-responders or early versus late responders is detected, statistical methods for offsetting the bias can be employed. For example, weighting adjustments can also be employed. Adjustment using data from a sub-sample of non-responders followed-up intensively, weighted for the original proportion of non-responders, can be performed. However, weighting can sometimes produce disastrous results because weighting schemes assume that (1) the respondents represent a random sample of their subgroup, and (2) all relevant differences between responders and non-responders have been taken into consideration in defining subgroups, 13 both of which are tenuous assumptions (102). While weighting adjustments are easy to implement and often employed, they at best will attenuate, but not necessarily eliminate, non-response bias. For a more detailed discussion of data analysis strategies for taking non-response into account, see Kessler et al. (107). Non-response bias in social science literature The literature on survey response is enormous. Some of the first studies were published as early as the 1920’s and 1930’s, although the bulk of the literature did not begin to appear until the 1940’s. The majority of the early research came out of the social sciences. Comprehensive bibliographies of these early studies have been published (108- 110). An example of one such early study is that conducted by Finkler in 1946 (111) on commercial peach production by growers in the State of North Carolina. One of the survey questions asked how many trees the grower owned; the exact number of trees owned for each grower was previously known. The results are shown in Table 1. Table 1: Responses to three mailings in a postal survey of North Carolina peach growers, 1946 (111). No. growers Percent of Mean no. of population fruit trees per grower Response to first mailing 300 10 456 Response to second mailing 543 17 382 Response to third mailing 434 14 340 Non-responders after three mailings 1,839 59 290 Total population 3,1 16 100 329 The presence and direction of non-response are clear. Growers with a large number of fruit trees were more likely to respond and more likely to respond in an earlier 14 mailing than growers with fewer trees. Population estimates based solely on the sample obtained from the three mailings would have greatly overestimated the actual number fruit trees owned by each grower. Attempting to summarize the socio-demographic determinants of response is a daunting task. This is due to the vast literature and the inconsistency within it. Bridge (102) and Goyder (78), however, have reviewed the literature and have attempted to summarize the existing evidence based on hundreds of early studies. Some of their main conclusions are presented in Table 2. From Table 2, the primary socio-demographic variables that are related to survey response are education, income, and age. Education and income are positively correlated with response, while age is negatively correlated with response. Said another way, non- responders have historically tended to be less educated, have a lower income, and be of an older age. It should be noted that the single most important factor in predicting response is interest in the topic of survey (102). If the topic interests the respondent, and s/he has something positive to report, then the respondent is very likely to complete the questionnaire. For example, in a 1939 study by Stanton (112), teachers who used radios in the classroom were more likely to respond to a survey about the educational use of the radio. In another study, Pace (113) found that alumni who had graduated from a university were more likely than dropouts to respond to a questionnaire from the university. Finally, Edgerton, Britt, and Norman (114) found that winners in a science fair contest were most likely to respond to a follow-up survey, honorable-mention recipients were next most likely to respond, and “others” were least likely to respond. 15 Table 2: Summary socio-demographic variables and their relationship with response status (abstracted from Bridge [102] and Goyder [78]). Variable Effect Education Income Age Sex Marital status Ethnicity Others In general, education is positively correlated with response. However, in some studies, highly educated individuals have been difficult to contact. Income is positively correlated with response. However, as for education, in some studies, the wealthy have been difficult to contact. Age and response are negatively correlated for response once contacted (older individuals are less likely to respond once contacted). Some studies have reported that age and response are positively correlated for contact (older individuals are easier to contact than younger individuals, because of the frequent shifts in residence and active life style of the young), but this finding was not consistent. No relationship exists between sex and response. Non-married individuals are more difficult to contact than married individuals, but this may be confounded by age, as non-married individuals tend to be younger. Once contacted, married and non-married individuals generally respond at similar rates. At least one study cited by Bridge (102) found that blacks had a lower response rate than whites, but this study also noted that ethnicity was highly correlated with income. Other variables were evaluated, such as work status, religion, country of birth, home ownership, dwelling type, family size, and urban vs. rural habitat, but none had convincing evidence of a relationship with response. l6 Non-response bias in epidemiological and health sciences literature More recently, studies of non-response began to appear in epidemiological and health sciences research predominately in the 1970’s and have grown in importance ever since. An early study was performed by Gordon et al. (115) in 1959. Using the Framingham cohort, the authors sampled 6,532 individuals for their study and were able to perform examinations on 4,494 persons, for a response rate of 68.8%. The authors found that more non-responders than responders died within the first five years of the study, as depicted in Table 3. Table 3: Age-adjusted death rates for responders and non-responders for the first five years of the Framingham study, 1953-57 (adapted from Gordon et al. [115]). Annual age-adjusted death rate Men Women Responders (n=4,494) 8.2 3.2 Non-responders (n=1,964) 10.4 6.9 Refused (n=1,464) 11.9 7.3 Moved (n=426) 4.6 3.6 Incapacitated/lll (n=74) 14.8 1 1.9 Died during recruitment period (n=74) - - For both males and females, non-responders had higher age-adjusted annual death rates compared with responders. In particular, those non-responders who had refused to participate, or those who “voluntarily” choose not to participate, had even higher age- adjusted annual death rates. This contrasts with those non-responders who had moved out of the study site, or those who were “involuntary” non-responders. As would be expected, those who were incapacitated or too ill to participate had the highest annual age-adjusted death rate within the first five years of the study. From these observations, 17 the authors suggested that non-responders were on average more likely to be seriously ill than the responders. Other studies have reached similar conclusions. In a population-based study of cardiovascular disease in a planned suburban development in Southern California from 1972-1974, Criqui et al. (116) sampled 6,155 persons, of which 5,052 participated in the study, for a response rate of 82.1%. Analysis was restricted to those aged 30-79. The authors characterized the non-responders as less healthy than responders, at least in terms of past cardiovascular illness, based on the data presented in Table 4. Table 4: Age-adjusted comparisons of responders and non-responders to responses on health status in a population-based study of cardiovascular disease (adapted from Criqui et al. [116]). Males Females Non- Res- p“ Non- Res- pa resonders ponders resonders ponders Personal health history Hosp. for heart failure % 4.2 1.1 0.0001 3.1 0.8 0.0001 Hosp. for heart attack % 9.0 8.0 0.28 4.1 3.0 0.13 History of diabetes % 4.9 5.7 0.31 6.0 3.0 0.0018 History of stroke % 3.7 3.0 0.28 1.7 1.3 0.27 Family history (1'‘ degree relatives) Family history heart attack % 22.8 34.2 0.0001 25.1 40.5 0.0001 1f previous question yes, % 12.9 15.1 0.32 17.8 18.9 0.4 was it at age 50 or under Family history stroke % 20.3 22.3 0.23 15.6 30.5 0.0001 Family history diabetes % 12.7 15.7 0.10 14.8 17.8 0.09 Risk factors for disease History of hyperlipidemia % 13.1 17.2 0.03 7.9 14.0 0.001 History of hypertension % 23.4 23.8 0.44 24.4 24.7 0.46 No. eggs eaten weekly # 4.0 4.2 0.25 3.0 3.2 0.08 Current cigarette smoker % 26.9 22.4 0.05 31.6 26.6 0.03 a Z-test for differences between proportions. Both male and female non-responders were significantly more likely than responders to have ever been hospitalized for a heart failure. Female but not male non- responders were significantly more likely to have a history of diabetes. Both male and 18 female non-responders were also significantly more likely than responders to be current cigarette smokers, a finding replicated in other studies (106, 117). Interestingly, both male and female responders were more likely than non-responders to have a history of hyperlipidemia or a first degree relative with a previous heart attack. The authors thus characterized the responders as the “worried well”, or those who had lower prevalence of disease but had higher prevalence of risk factors for disease, as compared to non- responders. Despite the differences found, however, Criqui et al. (116) believed that responders were generally representative of the target population. They based this conclusion for several reasons: the response rate was above 80%; subsets of the population had similar age-sex distributions; and the differences, while statistically significant, were generally small, suggesting that calculations of prevalence or relative risk would be relatively unbiased. For example, the variable with the largest percentage difference between responders and non-responders is the question of a family history of a heart attack for females, 40.5% vs. 25.1%, respectively. The authors claim that if all non- responders had participated, this percentage would have been reduced fiom 40.5% to 37.8%, and the effect of this bias on subsequent relative risk calculations would probably have been minor. However, the authors did note that the potential for significant non- response bias might increase in a study with larger differences between groups and/or a higher non-response rate. If the response rate had been only 50%, the true prevalence of a family history of a heart attack for females would have decreased from 40.5% to 32.8%. In another health survey carried out by Macera et al. (118), all persons who visited a free health clinic in Dallas, TX at least once from 1972-1981 were surveyed in 19 1982 to obtain health outcome information, including questions on physical activity, demographics, and health conditions that had developed since their last visit. Of the 18,806 questionnaires mailed, 3,224 were returned for bad addresses and an additional 142 were not deliverable because of that person’s death. Of the 15,440 persons who received the questionnaire, 11,972 responded (77.5%). To assess any potential non- response bias, the authors compared data from the first clinic visit for the responders and non-responders. This data is presented in Table 5. Among men, responders were more likely to be older, thinner, and able to perform on the treadmill longer than non-responders. Women responders were similarly able to perform on the treadmill longer than non-responders. Both male and female responders were more likely to exercise more and smoke less than non-responders. Responders reported higher percentages of all family history of illness than non-responders (except for women having a father having died of CHD, which was equal). The differences were statistically significant for a family history of cardiovascular disease and stroke in both men and women, and additionally for a family history of hypertension in males only. However, the responders and non-responders did not differ statistically on personal medical history characteristics or clinical measurements, except for male responders having significantly lower uric acid levels than male non-responders. 20 Table 5: Comparison of baseline characteristics of non-responders and responders to a mailed follow-up survey of 15,440 persons who attended a preventive medicine center in Dallas, TX at least once from 1972-81 (adapted from Macera et al. [118]). Men % Female % Non- Non- responders Responders responders Responders (n=2,624) (n=9,409) (n=844) (n=2563) Physical characteristics Age“ 20 25* 22 26 Waist girthb 7 8 5 8 Body Mass Indexc 23 19* 20 18 Treadmill testd 36 27* 36 28* Lifestyle behaviors Current non-exerciser 50 37* 54 38* Current smoker 23 19* 20 12* Current or past smoker 50 51 44 39 Alcohol usage 2 14 drinks/wk 21 19 7 8 Egg consumption 2 4 eggs/wk 41 38 26 30 Fried food consumption 2 4 times/wk 24 23 10 7 Family medical history Cardiovascular disease (CVD) 35 40" 35 42 Father died of CVD 19 21 19 19 Hypertension 30 34* 37 44 Obesity 31 34 35 40 Diabetes 20 21 24 27 Stroke 14 18* 15 22* Personal medical history Hypertension 16 16 10 1 l Hyperlipidemia 6 6 4 3 Diabetes 4 4 2 2 Asthma 6 6 6 6 Chest pain 17 18 21 19 Thyroid problems 3 3 13 16 Clinical measurements Total serum cholesterol > 220 ml 42 38 33 28 Serum glucose > 110 ml 16 15 9 6 Uric acid<3or>7 36 31* 7 6 Diastolic blood pressure 2 90 mm 14 12 6 5 Systolic blood pressure 2 140 mm 10 9 6 5 a Percent of men 2 50 years or women 2 49 years 5 Percent of men with waist girth 2 97 cm or women 2 75 cm C Percent of men with BMI 2 27.7 or women 2 30.5 cm d Percent of men with treadmill test s 780 sec or women s 495 sec "' p<0.001 21 Macera et al. (118) thus concluded that responders tend to have better health practices, such as regular exercise and non-smoking, and also tend to have a family history of disease of cardiovascular disease, hypertension, and stroke. Therefore they reasoned that using data to the mail survey to make estimates about the underlying population of the clinic would introduce bias into their results, insofar as estimates of prevalence of current non-exercise or smoking habits would be spuriously low and estimates of prevalence of physical fitness and family history of cardiovascular disease, hypertension, and stroke would be spuriously high. These studies are just a few examples of studies conducted to assess the role of non-response bias in the epidemiological and health sciences literature. 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Overwhelmingly, non-responders compared to responders tended to be smokers (106, 116-118, 120, 123, 127, 128, 134), with increased cough and phlegm production (123) and requiring more frequent hospitalization for respiratory disease and COPD (127). Most studies that examined differences in mortality between responders and non- responders found a higher all-cause mortality among the non-responders (115, 122, 124, 131), with increased mortality due to myocardial infarction and all cancers (131), although one study (119) did not find such an association. More conflicting results arose when looking at chronic disease. Some authors found an increased prevalence of congestive heart failure, diabetes mellitus, hyperlipidemia, and/or previous myocardial infarction and stroke among non-responders compared to responders (116, 130, 134). Other authors, however, found no increased prevalence for such conditions (118, 132). Criqui et al. (116) discussed the “worried-well” phenomena, as discussed previously, in which non-responders tended to have lower prevalence of disease but had higher prevalence of risk factors for disease. Macera et al. (118), however, found somewhat divergent results. Although the authors did find an increased prevalence of risk factors for disease (increased family history of cardiovascular disease, hypertension, and stroke), much like Criqui et al., they found that in their study population non- responders were not as healthy as responders, as evidenced by an increased BMI and decreased exercise tolerance. Bisgard et al. (131) also found that non-responders tended to have higher BMI when compared to responders. Furthermore, other authors have 31 determined that non-responders tended to self-report poorer general health (121, 134) and required more frequent hospitalizations than responders (134). Interest in the study subject also tended to attract responders. Persons who did not feel well at the time of survey or were experiencing problems related to the study topic were more likely to respond (120, 129, 133), a finding consistent with previous literature (102). The data presented by the above studies seem to suggest that in general, non- responders can and do differ from responders with respect to certain morbidity and mortality endpoints. However, the data are far from consistent. Differences in study design, study population, and study topic likely play a sizable role in the discrepancies encountered within the literature. Furthermore, data from non-responder studies are presently limited, and no study to date has examined the role of non-response bias in reproductive epidemiology studies. 32 CHAPTER 3 METHODS Population and setting The design of the Fisheaters Family Health Project (FFHP) has been described (67). Briefly, between 1993 and 1995 a questionnaire was mailed to 4,931 licensed anglers between 17 and 34 years of age and resident in one of 10 Michigan counties bordering a Great Lake (Figure 2). These counties were selected because of the high PCB burden in the sport fish of the surrounding waters due to localized industrial contamination, thereby maximizing the PCB exposure among the study population. Usable responses were received from 1,445 anglers, who form the study base for the results reported previously (13,67). Eligible participants for this study of non-response consisted of the 2,937 individuals (2,371 men, 566 women) who did not respond to the original FFHP screening survey and whose original survey had not been returned as undeliverable by the U.S. Postal Service. Due to the potential for differences in responses between men and women, the population was first stratified on gender. In addition, because individuals from different parts of the State are quite diverse and distinct from one another in terms of demographic, socio-economic, and behavioral characteristics, the population was stratified based on geographic region as well. Region 1 includes the counties of West Michigan: Allegan, Muskegon, and Ottawa counties. Region 2 includes the Bay Area counties: Bay, Midland, and Saginaw counties. Region 3 includes counties of Southeast Michigan: Macomb, Monroe, St. Claire, and Wayne counties. 33 Lake .S'upen‘or 11" w 1... J” I.“ Lake Huron Lea/'21 Counties l. Muskegon Lake 2. Ottawa M 0,1180” _ ,;:§:§: gig 3.A11egm 5 i 4. Bay 1 5" : 5. MIdlmd "'ozsé 323331233: 55,193,“? E] ”'2: ' f=;§5; iii: 73mm: 3 W? 8. Macomb ' I I iiifiés” 8 9. Wayne .4; y- 10. Monroe " Lake 3*“ :gzg' 333333 0.. ........ Figure 2: Target counties for the Fisheaters Family Health Project, Michigan. Based upon the population size in each region by gender cell, initial estimates called for a randomly selected sample of 40 men and 40 women from each region, for a total of 240 participants. These numbers were determined based on power calculations performed in Epi Info 6.02 (135). This sample size would provide adequate power to detect, at the 95% confidence level, a 10% difference in proportions between responders and non-responders within each region (n=80) as well as within each gender separately (n=120). Given the much larger numbers of participants that would be required to survey in order to increase our power, and considering the financial and time constraints of this project, it was felt to be impractical to attempt to detect a smaller difference or to attempt to detect within-region differences among men and women separately. For example, in 34 order to detect a 9% difference in proportions at the 95% confidence level, at least 100 participants per region would have been required, and in order to detect a 5% difference a sample in excess of 240 participants per region would be needed. Sampling Names and addresses of non-responders were imported into a Microsoft Excel (136) spreadsheet. After being sorted into their respective gender and region strata, non- responders were assigned random numbers using the RAND function and sorted by this number. Non-responders were then selected sequentially from each stratum for recruitment into this study until either the target sample size for each stratum was reached or until the population of non-responders for that stratum was exhausted. Identification of telephone numbers The original database of angler license applications from the Michigan Department of Natural Resources was previously obtained. This database, however, did not provide telephone numbers. Since the names and addresses of licensed anglers listed in the database were obtained in 1992 and 1993, at the start of the original FFHP survey, it was felt that a telephone number for the angler would best be located by using a telephone database from those years rather than using a database current at the time of this non-response study. It was expected that many would have changed residences during this intervening time interval, given the young age and relative mobility of the study population. Furthermore, many women might have married and hence changed their family names. Use of a 1992 database would, at a minimum, provide a telephone 35 number which could be used to initiate a tracing of the individual, whereas a 1996 database might have no number at all listed for that individual. A 1992 CD-ROM database of listed telephone numbers (137) was used to obtain anglers’ telephone numbers. Some licensed anglers would not be expected to be listed in the telephone directory, because they may have been children, spouses, partners, or friends of the telephone subscriber. In addition, because people often move within a city, it was thought that anglers who moved between 1991 and 1992, and who consequently had outdated listings and might not match on address, might still live in that city with the same telephone number. Therefore anglers were matched to a listing if they matched in either of the following ways: last name and street address; or first and last name and city, with no other matching name in that city. For example, an angler with a unique name in a city would be matched to a unique listing of that name in that city, regardless of street address. However, there was no way to match a common name in a community with a particular listing without the exact street address. Interview The instrument used for this telephone survey was based on the original FFHP screening survey. In order to increase participant compliance and response rates, the survey was adapted so that it could be administered by telephone in a five-minute period. Key questions regarding reproductive history and future productive plans, Great Lakes sport fish consumption and fishing habits, and demographic, socio-economic, and 36 behavioral characteristics were included. A copy of the survey instrument used is included in Appendix A. The administration of the telephone survey took place between November 1995 and April 1996. A protocol on how to handle situations such as encountering wrong numbers, busy signals, answering machines, and no answers was developed, based on a protocol developed for the Behavioral Risk Factor Surveillance System (138). In such situations, effort was made to reach the angler on five separate occasions during different periods of the day (morning, aftemoon, or evening) and on both weekdays and weekends before replacement. This protocol was established in order to minimize non-contact with those individuals who are employed during non-traditional hours. In general, however, most attempts at reaching eligible anglers occurred weeknights between the hours of 6:00 and 9:00 PM. All attempts were logged for proper book-keeping and tracking. The complete protocol is included in Appendix B. At the beginning of each telephone call, identification was made by the interviewer and the purpose of the call explained. The subjects were informed that their responses would remain confidential. A copy of the script used is included in Appendix C. If the subject agreed to participate, responses to the interview were recorded on a paper form with only the identification number attached in order to ensure confidentiality. Data entry Data were entered into a Microsofi Access (136) database concurrently to its collection and subsequently exported to SPSS for Windows 6.1.3 (139) for analysis. Participants were identified in the database only by their identification number. This 37 database was separate and distinct from the database matching identification number to study participant. Both databases were password-protected. These measures were all undertaken to ensure confidentiality. Statistical methods Initial analyses examined the distribution of all variables between non-responders and responders as a whole using the Pearson )8 test for dichotomous variables and independent samples t-test for continuous variables. Stratified analyses were also performed in order to examine the distribution of variables within each gender group and among the three regions for men. Previous research by Courval et al. (13) suggested a modest association, in men only, of Great Lakes sport fish consumption with risk of conception failure, defined as ever having failed to conceive after 12 months of trying. An attempt to replicate these results by performing logistic regression analyses on both the responder and the non- responder population was performed, recognizing that this study was under-powered to detect modest differences between the two groups. For these analyses, Great Lakes sport fish consumption was defined as the number of average—sized meals of fish caught from the Great Lakes or its tributary system in the past year by the angler himself or by someone that angler knew personally. Sport fish consumption was categorized first as a dichotomous variable (none vs. any), and second as a categorical variable with four levels (none, 1-12 meals, 13-24 meals, or 2 25 meals per year). In order to increase comparability, analyses were restricted to currently-married and ever-married males. It 38 was felt that these individuals were most likely to have attempted to conceive a child and thus most likely to have experienced conception delay. As in the main study, both unadjusted analyses and analyses adjusted for age, race, geographic region of residence, income, education, tobacco use, and alcohol consumption were performed. Individuals with missing covariate data were included in the adjusted models, with a ‘missing’ code applied in such cases, in order to maximize our sample sizes. All data analyses were performed with SPSS for Windows 6.1.3 (139). 39 CHAPTER 4 RESULTS The final disposition of all eligible study participants is provided in Table 7. Target cell sizes for men in Region 3 (Southeast Michigan) or for women in any region were not reached. The primary reason for failure to conduct an interview was the inability to identify a telephone number in our CD-ROM telephone database for the angler. This was particularly true in the regions in which target cell sizes were not reached, where 78% of the anglers were not listed, compared to only 56% of the men in Regions 1 and 2. Overall, 72% were not listed. Significantly, an additional 10% of the anglers had telephone numbers that were incorrect or disconnected at the time of this survey. Smaller percentages of anglers did not retum phone messages left with family members or on the answering machine, and there were a few anglers who did not answer the phone on successive attempts, were deaf and could not communicate, or had passed away. Of the 364 anglers reached, 230 men and 38 women completed the telephone interview, for a response rate of 74%. A complete tracking flowchart is shown in Figure 3. Because of the inability to reach target cell sizes for women, the three regions of women were combined into one for further analyses. 40 Table 7: Participation status in a survey of Michigan licensed anglers, by gender and region. Males Region 10 Region 20 Region 30 Females Total Eligible for non-response study 543 597 1,207 566 2,937 No contact attempted 68 52 0 0 120 No telephone number listed 261 312 945 439 2,030 Listed telephone number incorrect 54 48 68 46 216 Listed telephone number 10 13 33 8 64 disconnected Did not return phone calls 17 26 47 9 99 Answering machine 5x 3 8 6 5 22 Ring no answer 5x 7 2 8 2 19 Unable to communicate (deal) 0 l 0 0 1 Deceased 0 0 2 0 2 Refused Interview 26 20 3 l 19 96 Completed Interview 82 83 65 38 268 a Region 1: Allegan, Muskegon, and Ottawa counties. 5 Region 2: Bay, Midland, and Saginaw counties. C Region 3: Macomb, Monroe, St. Claire, and Wayne counties. 41 4,931 licensed Michigan anglers surveyed in 1993-95 1,445 Responders 505 Undelivered 44 Refused .7 2,937 Non-responders 120 Not selected/ sampling frame quota reached 2,030 No phone number identified in 1995—96 ‘ f l 787 Non-responders with telephone number 280 Disconnected or incorrect number 143 No contact 7 364 Non-responders contacted in 1995-96 96 Refused 7 268 Non-responders completed telephone survey Figure 3: Tracking flowchart of study participants. 42 Demographic characteristics of men Demographic, socio-economic, and behavioral characteristics among male responders and non-responders are presented in Table 8. Region-specific analyses of these characteristics for men are presented in Table 9. Although the largest percentage (42%) of male responders resided in Region 3, male non-responders from the same region comprise the smallest percentage (28%) of non-responders. This is consistent with our inability to contact eligible participants from and to reach our target cell size for this region. On average, male non-responders were approximately 1.5 years older at interview than were responders, 30.9 years vs. 29.5 years. This, however, may reflect the time interval between the two studies. The median year of birth for male non-responders was actually one year later than that for responders, suggesting that, if interviewed at the same time, male non-responders on average would have in fact been younger than responders. These trends were consistent within all three regions. Interestingly, male non-responders tended to be both older and younger than their responder counterparts: higher percentages of male non-responders were found at ages 21-26 years and at ages 35 years and older, with lower percentages in the age groups in between. There were virtually no male non- responders 20 years of age or younger, a finding consistent with the fact that non- responders were interviewed at a significantly later date. Male non-responders were more likely to be Caucasian than responders. Almost 99% of male non-responders were Caucasian, compared to 92% of responders. This trend was consistent within all three regions, and particularly for Region 3, in which this difference reached significance. In Region 3, no non-Caucasian males were recruited for 43 our non-responder population, despite the fact that this region contained the highest percentage of non-Caucasians in our responder population. No significant differences of marital status were found between male non- responders and responders. Overall, approximately 50-53% of both groups reported being currently married, 40-43% of both groups reported having never married, and about 7% of both groups reported being divorced, separated, or widowed. Significantly, a higher percentage of male responders residing in Region 1 (West Michigan) reported being currently married compared to non-responders of the same region as well as responders from the other regions. Non-responders reported higher incomes than responders. Almost 90% of non- responders reported annual incomes of $20,000 or more, and 40% reported annual incomes in excess of $40,000. This compares with approximately 75% and 32% of responders, respectively. These trends were consistent within all three regions. With respect to education, similar percentages of male non-responders and responders had earned a high school degree or less. Of those who attended college, male non-responders were slightly more likely than responders to have obtained a college degree. Twenty-two percent of male non-responders compared to 18% of responders had attained a college degree, although this finding was not statistically significance. These trends were similar among the three regions. 44 Table 8: Demographic, socio-economic, and behavioral characteristics among male non- responders and responders to a survey of Michigan licensed anglers. Non-responders (n=230) Responders (n=1, 129) pa 95% Clb 95% Clb Region of Residence <0.001 West Michigan % 35.7 (29.6, 42.3) 28.3 (25.7, 31.0) Bay Area % 36.1 (30.0, 42.7) 29.7 (27.1, 32.5) Southeast Michigan % 28.3 (22.7, 34.7) 42.1 (39.2, 45.1) Year of birth (median) year 1965 1964 Age at time of survey (mean) years 30.9 (30.0, 31.9) 29.5 (29.1, 29.8) <0.01“ Age at time of survey <0.001 320 years % 0.4 (0.0, 2.7) 5.6 (4.4, 7.2) 21-26 years % 32.7 (26.8, 39.2) 22.4 (20.0, 25.0) 27-32 years % 21.7 (16.7, 27.7) 42.2 (39.3, 45.2) 33-34 years % 11.9 (8.2, 17.0) 18.8 (16.6, 21.2) 235 years % 33.2 (27.2, 39.7) 11.0 (9.3, 13.0) Ethnic distribution <0.001 Caucasian % 98.7 (95.9, 99.7) 91.9 (90.1, 93.4) Other % 1.3 (0.3, 4.1) 8.1 (6.6, 9.9) Marital status 0.66 Never married % 43.2 (36.8, 49.9) 40.0 (37.1, 42.9) Married % 49.8 (43.2, 56.4) 53.0 (50.0, 55.9) Divorced, separated, widowed % 7.0 (4.2, 11.3) 7.1 (5.7, 8.8) Annual income <0.001 <20,000 % 10.4 (6.9, 15.3) 24.9 (22.4, 27.6) $20,000 - $39,999 % 49.6 (43.0, 56.2) 43.2 (40.3, 46.2) >= $40,000 % 40.1 (33.8, 46.8) 31.9 (29.2, 34.7) Highest education level 0.09 High school degree or less % 47.1 (40.5, 53.8) 44.2 (41.3, 47.2) Some college, no degree % 30.8 (25.0, 37.3) 38.0 (35.2, 40.9) College degree or higher % 22.0 (16.9, 28.0) 17.8 (15.6, 20.2) Tobacco use 0.10 Current smoker % 31.1 (25.3, 37.6) 38.6 (35.8, 41.5) Prior smoker °/o 20.2 (15.3, 26.1) 18.8 (16.6, 21.2) Non-smoker % 48.7 (42.1, 55.3) 42.6 (39.7, 45.6) Alcohol use in past year 0.001 None % 16.4 (12.0, 22.0) 9.1 (7.5, 11.0) < 1 drink/wk % 38.7 (32.4, 45.4) 48.2 (45.3, 51.2) 2 1 drink/wk % 44.9 (38.4, 51.6) 42.7 (39.8, 45.7) a Significance of chi-square test for differences in the distribution of the characteristic between response groups, unless otherwise noted. 5 95% confidence interval. 0 Significance of independent-samples t-test for the difference in the mean age at time of survey between response groups. 45 3.. ....N n... ...NN 4.... n: .x. .23.. .o 8.»... ””260 9... 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Demographic and behavioral characteristics of women On the whole, these trends for most of the characteristics described above in males were similar for females as well. These data are presented in Table 10. Female non-responders were on average two years older at time of interview than responders, 31.4 years vs. 29.4 years, and a significantly larger percentage of female non-responders were 35 years of age or older, 32.4% vs. 12.6%. Female non-responders were also more likely to be Caucasian, be currently married, have higher annual incomes, have a college degree, and report no alcohol consumption in the past year than their responder counterparts, although because of the small sample size, only the income and alcohol consumption characteristics reached statistical significance. 48 Table 10: Demographic, socio-economic, and behavioral characteristics among female non-responders and responders to a survey of Michigan licensed anglers. Non-responders (n=3 8) Responders (n=316) p“ 95% Cib 95% ab Region of Residence <0.01 West Michigan % 42.1 (26.7, 59.1) 19.9 (15.7, 24.8) Bay Area % 13.2 (5.0, 28.9) 29.4 (24.5, 34.8) Southeast Michigan % 44.7 (29.0, 61.5) 50.6 (45.0, 56.2) Year of birth (median) year 1963 1964 Age at time of survey (mean) years 31.4 (29.9, 33.0) 29.4 (28.9, 29.9) 0.020 Age at time of survey 0.02 320 years % 0.0 (0.0, 11.4) 2.9 (1.4, 5.6) 21-26 years % 18.9 (8.7, 35.4) 23.5 (19.0, 28.6) 27-32 years % 32.4 (18.7, 49.6) 43.9 (38.4, 49.6) 33-34 years % 16.2 (6.9, 32.4) 17.1 (13.2, 21.8) 235 years % 32.4 (18.7, 49.6) 12.6 (9.3, 16.9) Ethnic distribution 0.14 Caucasian % 97.3 (84.5, 99.9) 89.7 (85.7, 92.7) Other % 2.7 (0.2, 15.5) 10.3 (7.3, 14.3) Marital status 0.31 Never married % 24.3 (12.5, 41.3) 27.3 (22.5, 32.6) Married % 70.3 (53.1, 83.4) 59.5 (53.9, 64.9) Divorced, separated, widowed % 5.4 (1.0, 19.3) 13.2 (9.8, 17.6) Annual income 0.04 <20,000 % 6.3 (1.3, 20.4) 26.7 (22.0, 32.0) $20,000 - $39,999 % 46.9 (30.9, 63.5) 38.0 (32.7, 43.6) >= $40,000 % 46.9 (30.9, 63.5) 35.3 (30.1, 40.9) Highest education level 0.07 High school degree or less % 43.2 (29.7, 60.1) 37.3 (32.0, 42.9) Some college, no degree % 27.0 (14.5, 44.1) 45.0 (39.5, 50.7) College degree or higher % 29.7 (16.6, 46.9) 17.7 (13.8, 22.5) Tobacco use 0.48 Current smoker % 42.1 (26.7, 59.1) 35.7 (30.5, 41.3) Prior smoker % 13.2 (5.0, 28.90 21.2 (16.9, 26.2) Non-smoker % 44.7 (29.0, 61.5) 43.1 (37.6, 48.8) Alcohol use in past year 0.01 None % 26.3 (14.0, 43.4) 10.3 (7.3, 14.3) < 1 drink/wk % 55.3 (38.5, 71.0) 70.8 (65.4, 75.7) 2 1 drink/wk % 18.4 (8.3, 34.9) 18.9 (14.8, 23.8) 0 Significance of chi-square test for differences in the distribution of the characteristic between response groups, unless otherwise noted. b 95% confidence interval. 0 Significance of independent-samples t-test for the difference in the mean age at time of survey between response groups. 49 Fishing habits and fish consumption Table 11 presents data on fishing habits and fish consumption for both men and women. Region-specific analyses of these characteristics for men are presented in Table 12. Among men, non-responders as a whole fished significantly fewer days than did responders. Non-responder men fished in the Great Lakes on average 26.3 days in the past year, compared with 33.5 days for responders. In addition, 12.2% of non-responder men reported no fishing at all during the past year, compared to 4.3% of responders. Approximately 40% of non-responders and 50% of responders claimed to have fished 25 or more days in the past year. These trends generally hold for men when examined regionally, particularly for men in Regions 2 and 3. In Region 1, although there were a higher proportion of non-responder men who reported no fishing during the past year compared to responders, 12.3% vs. 3.3%, the non-responder men on average fished about the same number of days as did their responder counterparts, 34.2 and 36.8 days, respectively. Interestingly, non-responder men from Region 1 fished more days than the non-responder men from the other regions (22.1 and 21.8 days for non-responder men in Regions 2 and 3), although this was not statistically significant by the Kruskal-Wallis one-way ANOVA nonparametric test (p=0.11). These trends were similar for women, although both non-responder and responder women fished on significantly fewer days than the their male counterparts. Non- responder women on average fished in the Great Lakes on slightly fewer days in the past year than did responder women, 12.9 vs. 15.9 days, respectively, and a higher percentage of non-responder women reported no fishing at all during the past year, 28.9% compared 50 to 14.1%. Neither of these findings were statistically significant, however, due to the small sample size of non-responder women. For men, there was no clear pattern in consumption of Great Lakes sport fish. Over 40% of both non-responders and responders reported eating 1-12 Great Lakes sport fish meals in the past year. A higher percentage of non-responders, however, did not eat any Great Lakes sport fish in the past year compared to responders, 20.5% vs. 13.7%. For women, significantly more non-responders did not eat any Great Lakes sport fish meals in the past year compared to responders: about 45% vs. 25%, respectively. 51 Table 11: Fishing habits and Great Lakes sport fish consumption in past year among non- responders and responders to a survey of Michigan licensed anglers, by sex. Male non-responders Male responders pa (n=230) (n=1,129) 95% Clb 95% orb Days fished in waters of State of days 26.3 (22.2, 30.4) 33.5 (31.2, 35.8) <0.01“ Michigan in past year (mean) Days fished in waters of State of <0.001 Michigan in past year None % 12.2 (8.4, 17.3) 4.3 (3.2, 5.7) 1 — 12 days % 33.2 (27.2, 39.7) 28.9 (26.3, 31.7) 13 — 24 days % 14.4 (10.3, 19.8) 18.1 (15.9, 20.5) 2 25 days % 40.2 (33.9, 46.9) 48.7 (45.8, 51.7) Great Lakes sport fish meals 0.02 eaten in past year None % 20.5 (15.6, 26.4) 13.7 (11.8, 15.9) 1 — 12 meals % 40.6 (34.2, 47.3) 45.6 (42.7, 48.6) 13 — 24 meals % 20.1 (15.2, 26.0) 25.4 (22.9, 28.1) 2 25 meals % 18.8 (14.1, 24.6) 15.3 (13.3, 17.6) Female non-responders Female responders p0 (n=3 8) (n=3 16) 95% orb 95% ab Days fished in waters of State of days 12.9 (5.8, 20.1) 15.9 (13.3, 18.5) 046“ Michigan in past year (mean) Days fished in waters of State of 0.13 Michigan in past year None % 28.9 (15.9, 46.1) 14.1 (10.6, 18.5) 1 - 12 days % 42.1 (26.7, 59.1) 50.3 (44.7, 55.9) 13 — 24 days % 13.2 (5.0, 28.9) 17.3 (13.4, 22.0) 2 25 days % 15.8 (6.6, 31.9) 18.3 (14.3, 23.1) Great Lakes sport fish meals 0.05 eaten in past year None % 44.7 (29.0, 61 .5) 24.6 (20.0, 29.8) 1 - 12 meals % 28.9 (15.9, 46.1) 48.4 (42.8, 54.1) 13 —- 24 meals % 15.8 (6.6, 31.9) 16.3 (12.5, 20.9) 2 25 meals % 10.5 (3.4, 25.7) 10.7 (7.6, 14.8) a Significance of chi-square test for differences in the distribution of the characteristic between response groups, unless otherwise noted. 5 95% confidence interval. 0 Significance of independent-samples t-test for the difference in the mean number of days fished between response groups. 52 dawn. £53, 698% 8:88. c8389 85: when no 898:: :88 05 E nag—8&6 05 .8 .83 moan—smacogoaoefi mo 8:85:3m a .88: 33:28 82:: .532 55; .mqaoa 8:88. 8833 unficofignu 05 .3 5:2:me 2: =_ 80:20.:E 3.. “8. 0333-20 me 3585ch b .8658 0:83 28 .236 am 68:22 55082 ”m 539: o .8358 Bafiwmm v5 €5.22 Sam ”N came”. a 8:580 «355 93 acme—82 demo—2 n. :2qu o v.2 odm v.2 n4: 3.— NNN .x. 288 mm N Wmm a: fig ES 0.5 Sm .x. £88 vm I m— 5? «.mm ”av 93. fine ndm ..\o £85 2 I _ m2 Ndm _.: Q3 wN- m5 .x. 252 can.» .2:— 5 :88 mod Sac 2d 28:. .7...— team 8:: «8.0 9% m.mm edv 9mm 9% fine o\. 996 3 N ”.2 E. _.om m6. m5. Q! .X. mam—u vm I m— m.w~ 2% _.mm Eh N.n~ Sam ..\o 99% N- I _ ad Na Na.” WE m.m m.~_ .x. 052 .39» «8.. a. swig: 53. .85 :3 3 33m 3 can: a. 8%... 25 38.5 .39» 32. E sane—9.2 mmod Own a. _ N 85.: wdm _.Nm 8%.: «an Ném 3% .3 88m .3 9.853 E toga..— 9?: Angus Gen—c Gmmuav ASHE A3 mus Amwnav . Ba flouceamom Eoucoa8c Va “engined 83:83. Va— ncocaeamox 83°92 .52 .52 .52 on Ewan amas— & some. ‘ £3»?— omaaauueou .3 .82»: eon—.3: aqua—32 be that...» a 8 82.539. can 206:38553 22: «38a .39» .3.— E Egan—3:3 5.: to? 8:3 39.6 can 532. uE-Eh fi— 93:. 53 Reproductive characteristics Table 13 provides data on reproductive characteristics of the two populations. Table 14 provides region-specific analyses of reproductive characteristics for males. Among men, similar percentages of non-responders and responders reported having fathered at least one child, but non-responders were more likely than responders to have fathered two or more children, 40.5% vs. 28.1%, respectively. Consistently, non- responders were significantly less likely to intend to have at least one child in the next five years, 27.2% compared with 40.4% of responders. These trends were consistent among the regions. Similar trends persisted for women as well, but statistical significance was lost due to smaller cell sizes. A key component in analysis of response bias is the potential for selective response by those who have experienced the study outcome event. As shown in Table 13, among men, a small excess of responders (8.5% compared to 5.7% for non- responders) reported a period of conception failure, defined as trying to conceive and not succeeding for twelve months or more. This difference, however, was not significant. There was no difference in the proportion who reported a medically diagnosed reproductive problem with fathering a child; for both groups only 2.2% reported a medically diagnosed reproductive difficulty. For women, both non-responders and responders were several times more likely to report difficulty conceiving or having a medically diagnosed reproductive problem than men. However, the non-responders did not differ significantly from the responders for either characteristic. Indeed, female non-responders even reported a higher 54 prevalence of a period of conception failure (15.8%) than did female responders (11.6%). Thus, there was no suggestion of this response bias. Table 13: Reproductive history among non-responders and responders to a survey of Michigan licensed anglers. Male non-responders Male responders a (n=230) (n=1,129) p % 95% ab % 95% CI!) Fathered 2 I pregnancy 54.4 (47.7, 60.9) 51.4 (48.4, 54.4) 0.55 Fathered 2 1 live birth 52.4 (45.7, 59.0) 46.3 (43.4, 49.3) 0.09 Number of previous live births <0.001 None 47.6 (41.0, 54.3) 53.7 (50.7, 56.6) 1 11.9 (8.2, 17.0) 18.2 (16.0, 20.6) _>_ 2 40.5 (34.2, 47.2) 28.1 (25.5, 30.8) Intends to have 2 1 child within the 27.2 (21-7. 33-5) 40-4 (37.5. 433) <0-001 next 5 years Has tried, unsuccessfully, to 5.7 (3.2, 9.8) 8.5 (7.0, 10.3) 0.16 father/conceive a child for > 1 year Doctor has said that s/he would 2.2 (0.8, 5.3) 2.2 (1.5, 3.3) 0.98 have difficulty having children Female non-responders Female responders a (n=38) (n=316) P % 95% ab % 95% crb Experienced 2 1 pregnancy 65.8 (48.6, 79.9) 63.7 (58.1, 69.0) 0.80 Experienced 2 1 live birth 65.8 (48.6, 79.9) 55.1 (49.4, 60.6) 0.21 Number of previous live births 0.1 1 None 34.2 (20.1, 51.4) 44.9 (39.4, 50.6) 1 13.2 (5.0, 28.9) 19.9 (15.7, 24.8) 2 2 52.6 (36.0, 68.7) 35.3 (30.1, 40.9) Intends to have 2 1 child within the 3 1-6 (13-1. 48-3) 50-2 (44-6. 55-3) 0-03 next 5 years Has tried, unsuccessfully, to 15.8 (6.6, 31.9) 11.6 (8.4, 15.8) 0.45 father/conceive a child for > 1 year Doctor has said that s/he would 10.8 (3.6, 26.1) 11.9 (8.4, 16.1) 0.85 have difficulty having children a Significance of chi-scTuare test for differences in the distribution of the characteristic between response groups, within sex. 5 95% confidence interval. 55 :2»... 55.3 anew 8:88.. 80.30.. 0.3.8822: o... .o 8.395%: e... :. 8:88.....: 8.. .8. 2:8».-.8 .o 858585 : 8:88 o??? :8 .230 am 68:02 5:88.). ”m 8&3. o 8:58 BEES :8 .:::_:_2 Sam. ”N 8&3. .. 8:55: 55.80 :8 acme—8.2 .58.? u. 8&3. a 8.5.2.: 9...»...— b.8..=.: 2:... ::.: S n. 8.: ..~ 5: 3.: :.N n. .x. 2.5: 2. 2.... a: a... .28: .39. _ A .3. 2.8 a 8...... m _ .: ..:. o... 3.: on m: 5.: 4.: :.... .\. 3 £=a§3=m== .8... 2.: 88.» n «no: 2.. _:.:v .3... :8 8.: an: 3.: 3.: 9:: 3m .x. 5...... 2...0 . N 2:... 3 8.3.... 3: In :5 Nov .3: :8 .x. N N 3. 8. 2: o... :.:N .2. .\. . m... an: 5.: 3:. o. .v n... .x. 282 8.: 3.: :0: 3...... 9... 28.3... .o .382 2.: Sn «.2. X: «.8 NE 8.: 4...: 3.: .x. 5...: 2... . N 3.2.2.... ::.: :9. 8.. :m: 8: E: 8.: 0:: 2: .x. .238... . N 3.2.2.: 5.1: .8"... San... .3"... a. mu... awn... N... m.o:..o..8x 38:88.. 1. 8.82.81 E0888. Va 80888: 88:88. IcOz IEOZ. ISOZ um 8&3. :N 8&3. :. 8&3. :28. 2.1.638» .3 ago—w...“ .888: gut—9.2 .: 8?...» a S 80:558.. :5. 88:88.78: M85: Dem... o>.8=:e.:.o~. ”v. «Ben. 56 Logistic regression analyses Table 15 shows the results of the logistic regression models relating fish consumption in the past 12 months to the prevalence of a period of conception failure among both ever-married and currently-married male anglers. Among both responders and non-responders, there is an increased prevalence of a period of conception failure among those men who reported consuming any Great Lakes sport fish in the past year. The unadjusted odds ratio for conception failure among ever-married non-responders was 0.96 for any Great Lakes sport fish consumption in the previous year compared to non- consumers. Among ever-married responders, the odds ratio was 1.47. Afier adjusting for age, race, region of residence, household income, education, tobacco use, and alcohol consumption, the odds ratios were 2.24 and 1.52, respectively. It should be noted that these odds ratios differ from those presented by Courval et al. (13) because Great Lakes sport fish consumption of non-responders was recorded only for that within the previous year and not for lifetime consumption. Analysis for this study was restricted to Great Lakes sport fish consumption within the past year. A dose-response relationship between fish consumption and conception failure was found among ever-married responder men. This relationship was not evident among the non-responder men; however, the non-responders represent a small sample, and estimates are inevitably imprecise. On the whole, these trends were similar for currently- married male anglers as well. 57 Table 15: Associations between Great Lakes sport fish consumption and prevalence of a period of conception failure among male responders and non-responders to a survey of Michigan licensed anglers. Ever-married Non- responders Responders (n=129) (n=806) Non- responders Responders (n=129) (n=806) Great Lakes sport fish meals consumed in past year unadjusted odds ratio adjusted odds ratio a Model 1 None (-) (-) (-) (-) Any 0.96 1.47 2.24 1.52 Model 2 None (-) (-) (-) (-) 1 — 12 meals 1.13 1.35 2.89 1.39 13 — 24 meals 0.72 1.61 1.98 1.63 _>_ 25 meals 0.87 1.71 1.11 1.97 Currently married Non- Non- responders Responders responders Responders (n=1 13) (n=721) (n=1 13) (n=721) Great Lakes sport fish meals unadjusted odds ratio adjusted odds ratio a consumed in past year Model 1 None (-) (-) (-) (-) Any 1.56 1.89 2.81 1.95 Model 2 None (-) (-) H H l — 12 meals 1.76 1.68 3.21 1.71 13 - 24 meals 1.20 2.15 2.67 2.21 2 25 meals 1.50 2.40 1.71 2.88 a Adjusted for region, age, race, education, income, tobacco use, and alcohol consumption. 58 CHAPTER 5 DISCUSSION In this study, non-responders were approximately 1.5 years older at interview, were more likely to be Caucasian, and reported higher incomes than responders. No differences, however, were found with respect to education level, marital status, or smoking. Non-responders had fished fewer days in the past year and consumed fewer fish meals than responders. Compared with responders, non-responders were more likely to have had two or more children and were less likely to intend to have additional children in the next five years. However, these differences, while real, did not impact on the previously observed association between sport fish consumption and conception failure as published by Courval et al. (13). Among both non-responders and responders there was an increased prevalence of a period of conception failure among men who reported consuming greater quantities of Great Lakes sport fish. These results suggest that non-response bias is unlikely to have played a major role in the observed association. There are several limitations of this study. The first limitation was an inability to recruit a sufficient number of female non-responders. The total of 38 females out of a desired 120 provides very little statistical power. Indeed, on a nmnber of study variables, similar trends were observed for both males and females. For example, 28.9% of female non-responders reported having not fished in the Great Lakes within the past year, as compared to 14.1% for female responders. For men, these percentages were 12.2% and 4.3%, respectively. While clearly females in general were more likely than males to have 59 not fished within the past year, the trend is similar. While this difference reached statistical significance for men, it did not for women. This lack of power was also most notable on the number of previous live births, with both male and female non-responders reported having more children, being only significant for males. The second limitation of this study was the roughly two year delay in interviewing the non-responders. While the data for the original F F HP study was collected between 1993 and 1995, the data for this non-response study was collected in 1996. This two year delay correlates remarkably well with the non-responders mean age, which was 1.5 to two years older at the time of interview. They had, however, similar median years of birth. In fact, for males, median year of birth was 1965 for non-responders and 1964 for responders; if the non-responders and responders were assessed simultaneously, the non- responders may have been on average younger than the responders. This delay in assessment can predictably produce spurious results. Being on average two years older, non-responders could have been expected to have higher incomes, to have completed schooling and college, to have had a child, and to have completed their planned family. Many of the differences found between non-responders and responders are likely to be confounded by this delay. The differences of many socio- demographic and behavioral characteristics found in this study are not easily comparable to those found in the literature due to this critical delay in non-responder assessment. Ideally, this limitation could have been avoided had the non-responder study been conducted simultaneously with the main F isheaters study. The third limitation of this study is the possibility that the results could be invalid due to the differences in interview method. The responders were surveyed by a postal 60 survey. In contrast, the non-responders were surveyed by telephone interview. This raises the possibility of differential response between non-responders and responders. According to Dillman et al. (140), there are several major differences between mail and telephone survey. First, telephone interviews require the presence of an interviewer to read questions and record responses, whereas mail surveys can be done privately, directly, and virtually anonymously. The necessary social interaction of a telephone interview may effect answers from respondents. Respondents may be looking for the most socially acceptable response or not want to divulge personal and sensitive information to a total stranger. Second, telephone interviews require dependence on visual or aural communication, whereas mail surveys depend solely on written directions and cues. Dillman et al. (140) suggested that memory limitations and cognitive processes may effect responses during a telephone interview. Lengthy questions and the interviewer’s pace, which is frequently pressured, could make responding to the telephone questions more difficult. In contrast, mail questionnaire respondents can look back and forth at the question and answer choices as needed and answer at their own pace. Third, the context for responding differs between the two modalities. In telephone interviews, respondents answer one question at a time. In contrast, during mail surveys respondents can see individual questions as part of a larger set of questions; they can look ahead and preview questions and answer them in a different order. Despite the potential differences between mail and telephone surveys, few studies have directly compared data collected by the two methods. Of the handful of studies performed, there are conflicting results. In a study by McHorney et al. (141), mail 61 respondents were more likely than telephone respondents to skip questions, report a less favorable health status, and have a chronic medical condition. However, other studies have found little or no systematic differences in responses from mail and telephone respondents (105, 142-144). Mixed results have been reported across survey modes for tests of reliability and response validity (see McHorney et al. (141) for a brief review). In short, few generalizations can be gleaned about differential score reliability or response validity. A major limitation of this study was an inability to interview a true random sample of the non-responders to the original survey. Telephone numbers were unable to be found in a CD-ROM telephone database (137) for 72% of those eligible for this non- response study, and an additional 10% had disconnected or incorrect telephone numbers. The latter can be attributed primarily to the time interval between the two studies. Given our young, mobile population, it is not unreasonable to expect a significant percentage to have changed residences in this time interval. The former, however, cannot as easily be explained. A telephone database from 1992 was explicitly used to obtain names and addresses of licensed anglers, rather than one from a current one, in hopes of identifying more eligible anglers. It was felt that this would give the best chance of locating an individual, particularly if that individual had moved between then and the current non-response sub-study. If that individual had moved, a current telephone database would result in no listing; a previous database would, at a minimum, provide a telephone number that could be used to attempt a tracing. In addition, “sofi” matching criteria of either a last name and street address, or unique name and city, was used, without regard to address, in hopes of increasing sensitivity. 62 However, while these techniques did result in a tangible number of completed interviews, neither was notably successful in significantly increasing the low telephone number identification percentage. Furthermore, while a certain percentage of eligible anglers could be expected to have unlisted numbers, as well as to cohabit with an unrelated individual who was the telephone subscriber and therefore not be listed, these factors alone would not be expected to account for all of our difficulty. Regardless of the causes, the inability to interview a true random sample of the non-responders may have resulted in a study that continues to be biased, as interviewees represent the responders among a study of non-responders. Nevertheless, it is felt that the sample is reasonably valid, as the primary reason for non-participation was not related to the study population’s awareness of the hypothesis, but to the above-mentioned inability to identify telephone numbers for a large proportion of the population using publicly available information. Once an individual was personally reached, participation was 74%. Finally, this study cannot address the more critical aspect of the main study, which is the cross-sectional nature of the observed relationship. A time order to the association can not be assigned: indeed, it is likely that the period of conception failure was in the more remote past than the past 12 months for which fish consumption was estimated. Resolution of this limitation requires prospective data, which is currently being accrued (68). Despite these limitations, this study has a number of strengths. This study adds to the growing literature on non-response bias. Several socio-demographic and behavioral characteristics were assessed. Similarities and differences in results of different variables 63 provides for further intellectual thought and debate. In addition, this study is the first study to our knowledge to assess non-response bias in a reproductive epidemiological study. Furthermore, it provides validation to the findings of the relationship between sport-caught fish consumption and conception delay. While this study provides useful information, as with any study it could be improved upon. Future studies should give consideration to alternative recruitment methods. While in 1996 world wide web telephone directories were rather primitive, today they are quite advanced, and their use in searching for persons is suggested. Given that anglers are required to purchase annual fishing licenses, it may be possible to cross- reference names from previous databases to names on the current license database. Finally, the use of credit histories and banking information to locate individuals is a possible, albeit costly, method at locating individuals. Future studies should also consider the application of more advanced statistical analyses. The analyses conducted here consisted mainly of Pearson )8 test for dichotomous variables and independent samples t-test for continuous variables. Multivariate logistic regression modeling could be done in order to ascertain independent predictors of response. Finally, as mentioned above, ideally the non-responder sub-study should have been conducted simultaneously with the main Fisheaters study. Future studies should allow for non-response considerations in its planning stages. 64 APPENDICES 65 APPENDIX A TELEPHONE CALLING RULES OF REPLACEMENT CODE 01 02 O3 04 05 O6 O7 08 09 10 Completed interview Wrong number Non-working number Ring no answer (five rings) Answering machine -- left message Line busy Language barrier Refused interview Correct number but angler not home Angler home but bad time -- appointment made EXPLANATION/RULE Do not replace. Angler does not live at this residence. Replace. Usually recognized by a recording or fast-busy signal. Replace. Normal telephone ring which no one answers. Replace after five (5) calling occasions, each consisting of three (3) attempts, and occurring at varying periods of the day and on different days (weekday, weeknight, weekend). Answering machine picks up. Leave name, message (script), and l-800#. Replace afier five (5) calling occasions, occurring at varying periods of the day and on different days (weekday, weeknight, weekend) Replace only after five (5) calling occasions, each consisting of three (3) attempts at 2 10 minute intervals, and occurring at varying periods of the day and on different days (weekday, weeknight, weekend). Angler does not speak English well enough to be interviewed and there are no interviewers who speak his/her language. Replace. Replace. Other family member answers telephone, but angler him/herself is not home. Attempt to determine when angler will be home and schedule an appointment. Angler home, but bad time for interview. Appointment scheduled. 66 CODE 11 12 13 Terminated within interview Respondent unable to communicate Angler no longer resides at this residence -- left 1- 800# EXPLANATION/RULE A hang-up or refusal to continue at some point after the first question has been asked (this does not mean the respondent refused a particular question). If disconnection was accidental, phone again and attempt to complete interview; otherwise, consider completed. Physical/mental impairment. Example: respondent is deaf. Replace. Family (e.g., parents) resides at residence, but angler has moved. Give 1-800#. 67 APPENDIX B QUESTIONNAIRE I would first like to ask you some questions about your fishing and fish eating habits. 1. In this past fishing year, from April 1, 1994 to March 31, 1995, how many days did you go fishing in waters in the State of Michigan? In April, May, and June of this past fishing year (1994), how many meals of Great Lakes sport fish that were caught by you personally or by someone you know did you eat? In July, August, and September of this past fishing year, how many meals of Great Lakes sport fish that were caught by you personally or by someone you know did you eat? In October, November, and December of this past fishing year, how many meals of Great Lakes sport fish that were caught by you personally or by someone you know did you eat? In January, February, and March of this year (1995), how many meals of Great Lakes sport fish that were caught by you personally or by someone you know did you eat? How do these amounts of fish that you eat during this past fishing year compare with previous years? Would you say you ate about the same, more than usual, or less than usual? days meals meals meals meals same more less Now I would like to ask you some general questions about your health. 7. Have you smoked more than 100 cigarettes during your entire life? NO: GOTO QUESTION 9. 68 yes no 10. 11. 12. 13. 14. 15. Do you currently smoke cigarettes? How often have you drunk alcoholic beverages over the past 12 months? 1 Never 5 4-6 days/week 2 Once a month or less 6 About once a day 3 > l/mo. but < l/wk 7 More than once a day 4 2 l/wk but < 4 days/wk How many times have you and any partner conceived a child together? NONE: GOTO 12. How many of these have resulted in a live birth? Have you ever had a child with a birth defect? How many children do you intend to have within the next five years (not including any child if currently pregnant)? Did you and any partner ever try for more than one year to conceive a child without being able to do so? Has a doctor told you that it would be difficult or impossible for you to have children? NO: GOTO 15. What was the reason? Now I would like to ask you some questions about yourself. 16. 17. In what year were you born? What is your main racial background? 1 African-American 4 Caucasian 2 American Indian 5 Hispanic 3 Asian/Pacific Islander 69 code yes no preg. births 19 code yes no kids yes no yes no 18. What is the highest level of school you have completed? 1 No high school degree 3 Some college 2 High school degree 4 College degree or code higher 19. What is your present marital status? 1 Never married 4 Separated 2 Married 5 Widowed 3 Divorced code 20. Which category best describes your total family income for 1994? 1 < $20,000 3 $40,000 or more 2 $20,000 to $39,999 code 21. Do you have a spouse or partner? yes NO: GOTO END. no YES: May I ask some questions of him/her? END: Thank you very much for taking the time to answer these questions. Like I said before, your responses will be very helpful in the analysis of our data and will be kept strictly confidential. I greatly appreciate your help. Do you have any questions or comments? Would you like to receive any information about our study? NO: Well, thank you, again. Goodbye. YES: Can I confirm your address? My records indicate that you live at... l. Wants information about study B 1. Correct Address 2. Does not want information 2. New Address: about study COMMENTS/QUESTIONS: 7O APPENDIX C QUESTIONNAIRE SCRIPT AND LOG Name: Address: Hello, may I speak with (First and last name)? Hi, my name is Gene Tay. 1 am a graduate student at Michigan State University, and I'm working with the Fisheaters Family Health Project, which is a project that is looking at people's eating habits of Great Lakes fish. Within the past year or two, we mailed a questionnaire to you on this topic, but we did not receive it back. At this time, I am not asking you to participate in our study, but 1 would like to ask you a few questions about your fish eating habits and your family background so that we can learn whether those who responded to our questionnaire are different from those who did not. 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