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13
Minimally Invasive and Innovative Methods for Biomeasure Collection in Population-Based Research

Stacy Tessler Lindau and Thomas W. McDade


A new laboratory for health research has emerged at the intersection of the social and biomedical sciences. Sociological, demographic, and economic inquiries that have traditionally relied on self-reported health data are increasingly complemented by objective physical measures at the individual level. Biomedical investigations constrained by biases derived from clinic-based samples can now pursue questions about health disparities between social groups and about mechanisms linking social conditions to health and disease. Data from large probability samples can also provide valuable reference data for clinical diagnosis. Broad advances in information and biomedical technology, combined with emphasis on interdisciplinary research from the National Institutes of Health (2005), the National Academy of Sciences (2004), and others, have given momentum to new approaches to primary collection of individual-level health data that span subjective and objective social, health, and biophysiological domains. Hybridization of gold standard social science methodologies with minimally invasive techniques for biophysiological data collection in the home or in vivo defines a new frontier for health research.

In large part, these advances derive from rich traditions of field-based research that have valued the integration of multilevel data toward an understanding of human health and development. In the last several years, anthropometric measures (e.g., height, weight, waist and hip circumference) have replaced self-report or subjective estimates in many population-based studies and have proven highly clinically relevant.



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13 Minimally Invasive and Innovative Methods for Biomeasure Collection in Population-Based Research Stacy Tessler Lindau and Thomas W. McDade A new laboratory for health research has emerged at the inter- section of the social and biomedical sciences. Sociological, demographic, and economic inquiries that have traditionally relied on self-reported health data are increasingly complemented by objective physical measures at the individual level. Biomedical inves- tigations constrained by biases derived from clinic-based samples can now pursue questions about health disparities between social groups and about mechanisms linking social conditions to health and disease. Data from large probability samples can also provide valuable reference data for clinical diagnosis. Broad advances in information and biomedi- cal technology, combined with emphasis on interdisciplinary research from the National Institutes of Health (2005), the National Academy of Sciences (2004), and others, have given momentum to new approaches to primary collection of individual-level health data that span subjec- tive and objective social, health, and biophysiological domains. Hybrid- ization of gold standard social science methodologies with minimally invasive techniques for biophysiological data collection in the home or in vivo defines a new frontier for health research. In large part, these advances derive from rich traditions of field-based research that have valued the integration of multilevel data toward an understanding of human health and development. In the last several years, anthropometric measures (e.g., height, weight, waist and hip cir- cumference) have replaced self-report or subjective estimates in many population-based studies and have proven highly clinically relevant. 

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 BIOSOCIAL SURVEYS Similarly, clinical measures, such as blood pressure sphygmomanometry, spirometry, and bone densitometry, have been successfully incorporated into epidemiological and other population-based health research. Inves- tigators seeking to incorporate biophysiological measures must regularly choose between tried and true measures with established validity, reli- ability, and predictive power and experimental or cutting-edge measures, such as those that may have unknown clinical utility or are newly adapted to home-based collection procedures. For this reason, in our review of innovative biophysiological methods suitable for population-based research, we include (1) methods with a track record of successful implementation in population-based research, (2) established clinical methods amenable to use in population settings, and (3) emerging and experimental methods with promise for future population research. This review is oriented toward experienced popu- lation researchers with interest in health but with limited experience in the collection of objective measures of biological function. We emphasize procedures and rationale for collection of biological measures that can be reasonably implemented in field settings and that can be meaningfully integrated with survey research. ISSUES IN THE APPLICATION OF MINIMALLy INvASIvE METHODS Biological measures collected in the population setting can include direct measures of physical or physiological characteristics (e.g., hip cir- cumference, blood pressure), functional testing (e.g., cognitive function, balance, grip strength), or collection of specimens that require laboratory processing in order to generate analyzable data. Such data may also be generated via experimental design (e.g., neuropsychiatric or olfactory testing). In traditional survey research, such constructs are approximated using self-report or subjective assessment by the study subject or the data collector (or both). Translation of clinical or other laboratory methods for data and specimen collection to the population setting can occur by replication or adaptation. For example, investigators may choose to replicate the clinical encounter by sending a clinician, nurse, or phlebotomist to the home to conduct a physical examination or venipuncture for blood, or to bring participants into a mobile clinic close to where they live or work. Alternatively, adaptation of clinical or experimental laboratory methods using minimally invasive strategies and nonmedically trained interview personnel may enhance the feasibility of data collection and prove more cost-effective (Rockett, Buck, Lynch, and Perreault, 2004). Furthermore, the thrust for minimal invasiveness in population-based health research

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 STACY TESSLER LINDAU and THOMAS W. MCDADE encourages technological innovation (e.g., development of easily portable medical equipment, adaptation of venous blood assays for use with dried blood spots) that may contribute to improvements in clinical medical services, particularly in remote and resource-poor areas. Data from the largest ongoing population-based health study in the United States, the National Health and Nutrition Examination Survey (NHANES), uses a replicative approach (e.g., state-of-the-art mobile clinics) and provides a wealth of gold standard measures against which adapted methods can be benchmarked. As with any survey measure, several key considerations should guide decisions regarding implementation and application of biomeasures in population research. Test performance characteristics, such as reliability, validity, sensitivity and specificity, in combination with information about the expected distribution of the measure of interest in the population, require close attention. Issues particularly relevant to biological measures include the relationship of the instrument and measure to the clinical or laboratory gold standard, focused training of data collectors who may have limited experience with these methods, and quality control at the levels of data collection, transportation, and sample analysis. Changes in the availability of instrumentation and laboratory reagents may pose challenges for comparability across time and studies. Knowledge about the physiological and biological mechanisms pertinent to the system of interest, as well as variations in these across populations, is critical; this informs the sample design and size, timing, interpretation, consider- ation of relevant confounders, and the full range of environmental and contextual factors that may influence the measure and the process of measurement. In the context of population-based research, several criteria must be met in order to achieve the goals of minimal invasiveness (Box 13-1). Minimally invasive methods aim to minimize burden to and maximize the safety of research subjects and data collectors and to contain research costs (York, Mahay, and Lindau, 2004; Mack, 2001). BIOMEASURES AND TECHNOLOgIES WITH ESTABLISHED USE IN THE POPULATION SETTINg Anthropometrics External measures of physical dimensions can be used to assess body size and composition as indicators of energy balance and nutritional his- tory (Gibson, 2005; World Health Organization, 1995). Anthropometric measures can be performed quickly with portable equipment at minimal cost and therefore represent a set of objective health measures with low

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 BIOSOCIAL SURVEYS BOX 13-1 Principles of Minimal Invasiveness in Population-Based Biomeasure Collection 1. Compelling rationale: high value to individual health, population health, or scientific discovery. 2. In-home collection is feasible. 3. Cognitively simple. 4. Can be self-administered or implemented by single data collector during a single visit. 5. Affordable. 6. Low risk to participant and data collector. 7. Low physical and psychological burden. 8. Minimal interference with participant’s daily routine. 9. Logistically simple process for transport from home to laboratory. 10. Validity with acceptable reliability, precision, and accuracy. barriers to implementation. The availability of standardized methods and reference data improve the precision, reliability, and comparability of these measures (Lohman, Roche, and Martorell, 1988). Commonly obtained anthropometric measures include height and weight, as well as circumferences and skinfold thicknesses taken from various locations on the body (Lohman et al., 1988). Raw measures are often converted to indexes or compared with age- and sex-specific refer- ence values. For children, particularly in low-income settings, standard- ized scores for height-for-age, weight-for-age, and weight-for-height have long been used to identify short- and long-term growth faltering that increases risk for subsequent morbidity and mortality (World Health Organization, 1995). With growing awareness of an impending epidemic of overweight/obesity—both in the United States and internationally— body mass index (BMI, also called Quetelet’s index; weight in kg/height in m2) is frequently used as a tool for assessing weight relative to height in both children and adults. However, BMI cannot differentiate lean tissue weight from weight due to body fat, nor does it reveal the pattern of fat distribution (e.g., central versus peripheral) that may be more predictive of disease risk. Waist-to-hip ratio, waist circumference, and strategically placed skinfold measurements provide more direct indicators of the quantity and dis- tribution of fat and have therefore been implemented in a large number of epidemiological studies (Gibson, 2005). Better estimates of body fat also allow more accurate determinations of lean mass, which may have

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 STACY TESSLER LINDAU and THOMAS W. MCDADE implications for bone loss and glucose metabolism. Recently leg length in adulthood has received attention as a potential indicator of nutritional quality in early childhood, when leg growth is most rapid and may be compromised by adverse environments (Wadsworth, Hardy, Paul, Marshall, and Cole, 2002). More precise estimates of fat-free mass, fat mass, and relative body fat can be obtained through biological impedance analysis (BIA), using portable instruments that measure the impedance of a small electrical cur- rent passed through the body (National Institutes of Health, 1996). Com- puterized tomography, magnetic resonance imaging, and dual energy X-ray absorptiometry (DEXA) provide highly precise measures of body composition in clinical and laboratory settings, but they are too costly and cumbersome for field settings. However, relatively portable DEXA and ultrasound densitometry instruments have been successfully used in community settings to measure peripheral bone mass as a predictor of fracture risk (Andersen, Boeskov, Holm, and Laurberg, 2004; Wear and Garra, 1998). grip Strength Several population-based studies, particularly studies on aging, have incorporated measures of hand grip strength as a biomarker of general muscle strength. Grip strength offers a relatively simple, minimally inva- sive measure of motor performance that has been shown to correlate with health status and a variety of health outcomes, including general physical function, bone density, mobility, and long-term mortality (Schaubert and Bohannon, 2005; Bohannon, 2001). Early work using grip strength in a French population study demonstrated progressive loss in strength with age (Clement, 1974). Handheld dynamometry has been used as a research tool since 1916. In a thorough review of the technology, four classes of instruments commonly used for measuring grip strength in the clinical setting are described: (1) hydraulic dynamometers, (2) sphygmomanometers, (3) the vigorimeter (manometer with tubing and rubber ball), and (4) computer- ized dynamometry (Shechtman, Gestewitz, and Kimble, 2005). Hydraulic dynamometers, adapted from the gold standard Jamar™ dynamometer developed in 1954, have been the most widely used instrument in the population setting. This instrument uses a hydraulic mechanism to regis- ter static grip strength in pounds (kilograms) of force and is manufactured in portable, handheld models. Although protocols vary, testing typically involves two or three repeated trials of hand contraction separated by periods of rest with the subject in a comfortable seated position (for clini- cal protocol detail, see Shechtman et al., 2005).

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 BIOSOCIAL SURVEYS Related measures that have been successfully used in population studies include lower extremity dynamometry, body weight, body mass index, chair stand, and timed-up-and-go (Schaubert and Bohannon, 2005). Computer-based, portable dynamometry for hand grip, pinch strength, and lower extremity strength may significantly enhance measurement and ease of integration with survey data collected in population studies. Accelerometry Physical activity is a central part of energy balance, but it is difficult to measure through self-report methods. Accelerometry provides objective measures of the frequency, intensity, and duration of physical activity in everyday settings (Crouter, Clowers, and Bassett, 2006; Chen and Bassett, 2005; Welk, Schaben, and Morrow, 2004). Several watch-sized monitors are commercially available and are worn on the wrist, ankle, or waist. These monitors record acceleration of the body in one, two, or three dimensions and collect data for hours, days, or even weeks at a time. Some units have event markers, as well as light and temperature sensors. Data on accel- eration events per unit time are downloaded and analyzed to provide estimates of physical activity and energy expenditure. At this point, data reduction algorithms are not standardized, and different approaches have significant implications for outcome variables (Masse et al., 2005). Accelerometry has been widely used in the exercise sciences and is increasingly applied to research on obesity and sleep (Treuth, Hou, Young, and Maynard, 2005; Ancoli-Israel et al., 2003; Yngve, Sjöström, and Ekelund, 2002). An accelerometry module was added to NHANES in 2003. Heart rate monitoring has also been successfully used in field settings to measure physical activity and energy expenditure (Wareham, Hennings, Prentice, and Day, 1997; Leonard, Katzmarzyk, Stephen, and Ross, 1995), and improved estimates may be possible with the integration of accelerometry and heart rate data (Strath, Brage, and Ekelund, 2005). Dried Blood Spots Population-based health research often seeks to define the reciprocal effects of health and sociodemographic factors. Until recently, the mea- surement of biological measures in blood specimens was the exclusive domain of clinical or laboratory research. Many key biomarkers of health and physiological function are accessible only through serum or plasma, but venipuncture is a relatively invasive procedure that has served as an impediment to the application of biomeasures to population-level research. Dried blood spots—drops of capillary whole blood collected on filter paper following a simple prick of the finger—represent a viable

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 STACY TESSLER LINDAU and THOMAS W. MCDADE TABLE 13-1 Recent Applications of Dried Blood Spots (DBS) in Large Population-Based Studies Study N Biomarkers in DBS Great Smoky Mountains Study 1,071 Androstenedione, DHEAS, EBV antibodies, estradiol, FSH, LH, testosterone 7,000a Health and Retirement Study CRP, HbA1c, total cholesterol, HDL 5,000a Los Angeles Family and Neighborhood CRP, EBV antibodies, HbA1c, Survey total cholesterol, HDL 17,000a National Longitudinal Study of CRP, EBV antibodies, HbA1c Adolescent Health National Social Life, Health, and Aging 1,945 CRP, EBV antibodies, HbA1c, Project hemoglobin Work and Iron Status Evaluation 18,000 CRP, transferrin receptor 600b Tsimane’ Amazonian Panel Study CRP, EBV antibodies, transferrin receptor, leptin aProjected;final plans for analyses are to be determined. bPanel study; 3 waves of dried blood spots. NOTES: DHEAS = dehydroepiandrosterone sulfate; EBV = Epstein-Barr virus; FHS = follicle stimulating hormone; LH = luteinizing hormone; CRP = C-reactive protein; HDL = high- density lipoproteins; HbA1c = hemoglobin A1C. alternative to venipuncture and have recently been incorporated into a number of population-based studies. Table 13-1 summarizes the range of analytes currently being measured in blood spots among these studies. For additional information, see McDade, Williams, and Snodgrass (2007). This follows on the success of previous applications in remote settings internationally, including lowland Bolivia, Samoa, Kenya, Papua New Guinea, and Nepal (McDade et al., 2005; Shell-Duncan and McDade, 2004; Panter-Brick, Lunn, Baker, and Todd, 2001; McDade, Stallings, and Worth- man, 2000; Worthman and Stallings, 1997). Sample collection is relatively straightforward, and can be imple- mented by nonmedical interviewers: (1) the participant’s finger is pricked using a sterile, single-use disposable lancet; (2) up to five drops of blood are spotted onto filter paper; (3) samples are allowed to dry (four hours to overnight); and (4) they are shipped via express or standard mail to the laboratory for freezer storage (most analytes are stable in dried blood spots at normal room temperatures for at least two weeks). A small disc of dried whole blood is punched from the filter paper blood spot and is

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 BIOSOCIAL SURVEYS placed in solution to create a sample of reconstituted blood, analyzable in a similar manner as a serum or plasma sample. Since these filter papers were originally developed to facilitate the collection of blood samples from neonates as part of an ongoing national screening program, they are certified to performance standards for sample absorption and lot-to-lot consistency (Mei, Alexander, Adam, and Hannon, 2001). Protocols for over 100 analytes have been validated, including important indicators of endocrine, immune, reproductive, and metabolic function, as well as measures of nutritional status and infectious dis- ease (McDade et al., 2007). Many of these biomarkers have been applied clinically and may be used in survey research to determine risk for the development of disease or to gain insight into the impact of psychosocial or behavioral contexts across multiple physiological systems. Recent inno- vations in immunoassay technology now make it possible to simultane- ously quantify multiple analytes in one sample, rather than measuring one analyte at a time (Bellisario, Colinas, and Pass, 2000). Advantages of dried blood spots include the minimally invasive sam- ple collection procedure, simplified field logistics associated with sample processing, transport, and storage, and long-term stability under freezer storage that allows for future analyses as new biomarkers of interest, such as genetic markers, emerge (McDade et al., 2007). Disadvantages derive primarily from the fact that biomarker measurement in serum or plasma represents the gold standard in clinical assessment. Protocols must there- fore be validated specifically for use with dried blood spots, and results may not be directly comparable with serum or plasma methods. In addi- tion, the relatively small quantity of sample collected with blood spots may be an insurmountable limitation for some analytes that require large volumes of blood. Urine Among biospecimens amenable to home collection, urine provides a relatively simple platform for a very wide array of analyses. These include measures of renal, neuroendocrine, and sex hormone function, urine chemistry and cytology, nutritional measures, human chorionic gonadotropin (pregnancy hormone), microbes including sexually trans- mitted agents (e.g., chlamydia, N. gonorrhea, trichomonas, HIV) uro- pathogens, toxic substances, drugs, and drug metabolites (Rockett et al., 2004). Assays for the measurement of reproductive hormones or neuroen- docrine metabolites commonly require collection of multiple urine voids over time (e.g., overnight, 12- or 24-hour periods, or daily) and sometimes involve food restriction, but most other assays can be performed on a single urine specimen. For some assays, and with younger participants,

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 STACY TESSLER LINDAU and THOMAS W. MCDADE a first morning specimen can approximate an 8-12 hour multiple void collection. Measurement of urinary creatinine, a metabolic correlate of muscle mass that is normally found in relatively constant concentrations in urine, can be used to adjust for variability in urinary volume and con- centration (Garde, Hansen, Kristiansen, and Knudsen, 2004; Naranayan and Appleton, 1980). In addition to data obtained via laboratory processing, physical char- acteristics of urine, such as color, odor and temperature, can be useful. Urine temperature measured via an adhesive thermometer strip applied to the specimen cup can provide a close approximation of core body temperature. Decisions about specimen collection media depend on the volume of urine to be collected, the desired assays, and transportation issues. In most cases, urine is collected in plastic specimen cups or jugs. However, innovative collection methods include filter paper, diapers, and commode collection pans. Although filter paper collection is limited by the paucity of validated assays, further development could substantially improve ease of transportation and storage. For most assays, urine must either be refrigerated or frozen within two hours (Simerville, Maxted, and Pahira, 2005) of collection and therefore requires cold storage or packag- ing. This method has been widely used and found acceptable in popula- tion studies with younger and older samples, men and women, and in a variety of cultural settings (Auerswald, Sugano, Ellen, and Klausner, 2006; Zheng et al., 2005; Serlin et al., 2002; Wawer et al., 1998). Cell-free genetic information (DNA molecules) may also be obtained and amplified from urine specimens (Botezatu et al., 2000). Saliva For many biomarkers, saliva is an attractive alternative to blood sam- pling since collection is noninvasive and can be successfully performed by participants in their homes or as they go about their normal daily routines. Furthermore, many assays that can be collected via blood can also be obtained from saliva. Repeat sampling is possible, and saliva can be collected from infants and children with minimal difficulty. Most ana- lytes are stable at room temperature for up to a week—much longer for some analytes and collection devices—and saliva samples can therefore be stored and shipped without refrigeration for limited periods of time (Hofman, 2001). For these reasons, biobehavioral research has a track record of success with saliva sampling, both in experimental and natu- ralistic settings (Nepomnaschy et al., 2006; Gunnar and Donzella, 2002; Beall et al., 1992). Assays for physiological indicators of stress, immune function and

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0 BIOSOCIAL SURVEYS infectious disease, reproductive function, and drug use have been vali- dated for use with saliva (Hofman, 2001; Granger, Schwartz, Booth, and Arentz, 1999; Nishanian, Aziz, Chung, Detels, and Fahey, 1998; Kirschbaum and Hellhammer, 1994; Ellison, 1988). In most cases, salivary measures are of value only if they reflect circulating concentrations in serum. This may be an insurmountable obstacle for some analytes. For others (e.g., steroid hormones), concentrations in saliva are free of binding proteins and may provide a better estimate of the active fraction in circulation (Vining, McGinley, and Symons, 1983). Despite the noninvasive nature of saliva sampling, there are a number of important issues in the collection and processing of saliva that may significantly affect assay results. For example, concentrations of some ana- lytes are affected by salivary flow rate, as well as contamination of saliva with blood or food (Kivlighan et al., 2004; Kugler, Hess, and Haake, 1992). The use of oral stimulants to promote saliva production and the absorption of saliva into cotton rolls to facilitate sample collection have been shown to modify assay results for some, but not all, analytes (Shirtcliff, Granger, Schwartz, and Curran, 2001; Schwartz, Granger, Susman, Gunnar, and Laird, 1998). The composition of the containers (e.g., glass, polystyrene) in which saliva is collected and stored can also affect some results and should be evaluated for each analyte (Ellison, 1988). These issues, as well as the application of different laboratory protocols, can lead to difficulties in interpretation and comparison across studies (Hofman, 2001). Currently, salivary cortisol is frequently measured in naturalistic set- tings as a biomarker of stress, reflecting activation of the hypothalamic- pituitary-adrenal axis (Adam, 2006; Cohen et al., 2006; Kirschbaum and Hellhammer, 1994). Normal diurnal rhythms in cortisol production pro- vide the opportunity to investigate concentrations at different times of day, patterns of change across the day, and overall levels of cortisol expo- sure. However, this variation poses significant challenges to measure- ment, with little consensus on sampling protocols beyond recognition of the importance of collecting multiple samples per day, preferably across multiple days. The timing of sampling is critical, particularly in the morn- ing, and some studies have used timers or tracking devices to ensure compliance with collection protocols (Broderick, Arnold, Kudielka, and Kirschbaum, 2004).

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 STACY TESSLER LINDAU and THOMAS W. MCDADE TRANSLATION OF ESTABLISHED CLINICAL TECHNOLOgIES TO THE POPULATION SETTINg Ambulatory Electrocardiogram Holter monitors provide the possibility of measuring heart rate vari- ability continuously as participants go about their normal daily activi- ties. A compact monitor is worn on the waist or over the shoulder, and electrodes attached to the chest record heart rate activity for 24 to 72 hours. Analysis of electrocardiogram data can be used to assess cardiac arrhythmias and vagal tone, both of which have been analyzed in rela- tion to psychosocial factors and cardiovascular risk (Cacioppo, Tassinary, and Berntson, 2000; Kawachi, Sparrow, Vokonas, and Weiss, 1995). Holter monitoring is widely used clinically and has considerable potential for population-based research. Spirometry Pulmonary function testing is a mainstay of pulmonary medicine and plays an important role in the monitoring of such common diseases as asthma and obstructive pulmonary diseases. Spirometry has been used in several population studies, providing measures of lung volume (e.g., forced expiratory volume in one second or FEV1), and expiratory flow (e.g., peak expiratory flow or PEF), as well as estimates of lung capacity (e.g., forced vital capacity or FVC). More recently, spirometry has been incorporated into home-based studies as an indicator of vitality or disability and has been found to be a useful predictor of functional status and decline in the elderly. Data from large, population studies demonstrate that reduced lung function as mea- sured by FEV1 is associated with systemic inflammation (e.g., elevated C-reactive protein) and cardiovascular mortality independent of smoking (Sin, Wu, and Man, 2005), and it may be an independent predictor of long- term mortality (Schunemann, Dorn, Grant, Winkelstein, and Trevisan, 2000). A variety of portable spirometry devices are available, including handheld peak flow meters and computer-based devices (most clinical centers in developed nations use computerized spirometry). Interpreta- tion of spirometry data for diagnostic purposes requires comparison with an appropriate reference group. An excellent review provides spirometry testing and interpretation standards as well as an overview of available equipment (Ruppel, 1997). Data from NHANES III provide clinic-based spirometry reference values for whites, African Americans, and Mexican Americans ages 8-80 (Hankinson, Odencrantz, and Fedan, 1999). Evaluation of portable spirometers against laboratory spirometry

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 STACY TESSLER LINDAU and THOMAS W. MCDADE chemosensory abilities; odorants are presented and the subject is assessed on the ability to detect, identify, and discriminate these (Doty, 2006). Although most authors agree that no gold standard olfactory assessment test exists, many are compared with the widely used 40-item University of Pennsylvania Smell Identification Test (UPSIT) (Doty, Shaman, and Dann, 1984), a comprehensive, self-administered, odor identification test using a scratch-and-sniff technique. Although probably too time-consuming for most population studies, this measure has been used in over 50,000 individuals and is validated in several languages (Doty, 2006). A recent review article (Doty, 2006) describes the broad range of olfac- tory function measures available and provides a concise primer on the relative benefits and drawbacks of each. Shortened versions of the UPSIT have been successfully implemented in some clinical settings. In addition to the scratch-and-sniff technology, several other modalities offer options for population studies. These include “Sniffin’ Sticks,” which use a penlike odor device (Mueller and Renner, 2006; Hummel, Konnerth, Rosenheim, and Kobal, 2001; Kobal et al., 2000) and the odor stick identification test from Japan (Hashimoto et al., 2004). A laptop-based device is used for the sniff magnitude test, which assesses olfactory ability by comparing the nature of a person’s sniff in response to air versus sniff with odors. Although used primarily in the clinical research setting, the laptop-based operation and data capture offer unique advantages over other olfactory test methods. The NSHAP study protocol for olfactory function testing in a large probability sample of older adults is an adaptation of the short Sniffin’ Sticks olfactory function screening method (Mueller and Renner, 2006) and takes about 3-5 minutes to administer with very high coopera- tion rates (> 90 percent). vaginal Self-Sampling Vaginal self-sampling provides population and clinical researchers a minimially invasive method for obtaining data historically restricted to the clinical setting in which a gynecologic pelvic examination could be performed. In addition to microbial pathogen data, quantification of the normal vaginal flora and mucosal inflammation provide data points of relevance to health, sexual behavior and function, and systemic hormonal and inflammatory processes. In comparison to the methodologies sum- marized here, vaginal self-sampling imposes relatively high respondent burden, albeit much less so than a gynecological examination. The imple- mentation of this method, which requires a respondent to self-collect vaginal material in a private setting by inserting and rotating one or more small, sterile cotton- or Dacron™-tipped swabs, a small cytobrush, or a tampon in the vagina, derives primarily from experience in remote field

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 BIOSOCIAL SURVEYS settings where clinical pelvic examination is infeasible. Recent introduc- tion of flexible menstrual collection devices provides another method for self-sampling to obtain cervicovaginal secretions (Boskey, Moench, Hees, and Cone, 2003) and biomeasures of menstruation (Koks, Dunselman, de Goeij, Arends, and Evers, 1997). Once the samples are obtained, they are placed into transport media appropriate to the assays of interest and typically must be frozen and deliv- ered to a laboratory for analysis. Established clinical protocols for microbial testing are appropriate for specimens collected in the home; the NSHAP study is also developing protocols for home-based vaginal sampling appro- priate for cytological analysis. The vaginal self-swabbing method has dem- onstrated acceptability to study participants in a variety of settings (e.g., Bradshaw, Pierce, Tabrizi, Fairley, and Garland, 2005; Chernesky et al., 2005; Nelson, Bellamy, Gray, and Nachamkin, 2003; Serlin et al., 2002) and has performed favorably in comparison to urinary and clinical pelvic examina- tion protocols for testing of sexually transmitted infections (e.g., Harper, Noll, Belloni, and Cole, 2002; Knox et al., 2002). Vaginal self-sampling requires careful selection and training of field staff to maximize both respondent and data collector comfort with and understanding of the rationale and steps for the sampling procedures. Cervical self-sampling can also be accomplished using similar techniques and can approximate Papanicalou smear findings. However, interpreta- tion of assays, designed to detect dysplastic or malignant conditions, requires expert or expertly supervised personnel. Furthermore, anticipa- tory guidance for research subjects must include clear information about the physical effects of self-sampling (e.g., transient irritation or a small amount of discharge or blood are not uncommon following sampling in older women) and whether the specimen will or will not be used for cancer screening. In almost all cases, implementation of vaginal sampling in population studies requires a professional results reporting and coun- seling mechanism, such as that offered by the American Social Health Association. Magnetic Resonance Imaging Magnetic resonance imaging (MRI) is a critical diagnostic tool that provides a window into the inner workings of the human body, but one that is not easily adapted to population research due to technical and logistical constraints. Brain imaging is emerging as a fundamental tool for social neuroscience inquiry that aims to locate and map the neurological pathways through which social stimuli may influence health and health outcomes. However, MRI systems contained in mobile trailers must be transported to centralized locations for community-based research. In

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 STACY TESSLER LINDAU and THOMAS W. MCDADE addition, a portable MRI device has recently been developed that can pro- vide images of the extremities, although, at a weight of approximately 100 pounds, it is still too large for household surveys. Additional innovations in MRI and functional MRI are likely to lead to more portable instrumen- tation in the near future. ADjUNCT METHODS Widely used by psychiatric and psychological researchers, experi- ence sampling methods do not directly measure biological or physiologi- cal parameters, but instead serve as an adjunct to such measurements by providing documentation of real-time health-related information, feelings, symptoms, reflections, and thoughts or events pertinent to the individ- ual psychosocial context, such as stress, mood, emotion, and well-being. These include paper-and-pencil diary, thought sampling (Hurlburt, 1997), and ecological momentary assessment (Stone and Shiffman, 1994) and are uniquely home- or field-based. However, most examples in the literature involve convenience, rather than probability, samples. These methods aim to reduce reporting bias caused by recall and the constraints of close-coded instruments used in traditional designs. Although the use of paper-and- pencil diaries for research dates to the 1940s (Bolger, Davis, and Rafaeli, 2003), thought sampling and experience sampling methods appear to have emerged nearly simultaneously in the mid-1970s (Hurlburt, 1997). Recently, Kahneman and colleagues reported on the Day Reconstruction Method, a hybrid of experience sampling methods and time-budget measurement (Kahneman, Krueger, Schkade, Schwarz, and Stone, 2004). Vigorous debate in the recent literature about optimal diary methods suggests that no single method is superior for all study designs (Green, Rafaeli, Bolger, Shrout, and Reis, 2006; Broderick, Stone, Calvanese, Schwartz, and Turk, 2006; Bolger, Shrout, Green, Rafaeli, and Reis, 2006) and that these methods may, in some cases, be limited in their superiority to retrospective self-report (Takarangi, Garry, and Loftus, 2006). However, there is broad enthusiasm for advancement beyond paper-and-pencil methods toward augmentation with signaling devices (such as beepers, watch alarms, and phone calls) and for replacement of paper and pencil by electronic data collection using handheld devices, tablet personal com- puters, and electronic mail or web-based entries. The electronic devices offer the advantage of time- and date-stamping to corroborate subject compliance with the research protocol and to provide response-time data. Such devices may also enhance privacy, minimize the risk of data loss, allow for closer monitoring by researchers, and, combined with signaling, allow for dynamic flexibility in the intervals between entries. In addition to cost, some downsides of high-technology diary methods may include

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0 BIOSOCIAL SURVEYS higher respondent burden due to disruptiveness, logistics of interacting with and transporting the equipment, or unfamiliarity with computer technology. A clinic-based study of patient compliance showed signif- icantly higher compliance with an electronic versus paper-and-pencil diary (Stone, Shiffman, Schwartz, Broderick, and Hufford, 2003). Rapid innovations in diary research methods include real-time elec- tronic interaction with participants, voice recording and recognition tech- nology for verbal entries, behavioral medicine technologies that integrate self-report of subjective mood, and cardiovascular and physical activity indices with ambulatory monitoring. One can imagine the combination of these innovative technologies with global satellite positioning; the value of the data versus potential infringements on subjects’ privacy will have to be carefully weighed. Medication use records provide another important adjunct to biomea- sures, particularly in studies of aging. Self-report either by interview or self-administered questionnaire substantially limits the usefulness of such data. Direct observation of medication containers by in-home data collec- tors with immediate data entry is likely to improve data quality (Landry et al., 1988), but lack of unique identifiers for pharmaceuticals presents a major challenge with regard to coding and analysis. CONCLUSION Major advances in minimally invasive and portable biomedical tech- nology and growing collaborations between social, biomedical, and life scientists, combined with state-of-the art survey technology, offer a tre- mendous opportunity for new kinds of health-related discovery. Many of the methods described here are innovative by virtue of bringing them into the field or home setting. Others implement novel inventions motivated by a desire to reach generalizable or remote samples. In the case of bio- logical specimens, such as blood spots, saliva, vaginal samples, and urine, the power of the method is limited not by cooperation of the research participant, but by the availability and translation of suitable assays. The importance of high-quality, well-trained data collectors who embrace the rationale for biomeasure collection and can convey this to research par- ticipants cannot be underestimated. Innovations for population research that accomplish minimal invasiveness may facilitate cooperation in the clinical setting and diagnosis and treatment of disease in populations who otherwise would or could not access medical care.

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