Promoting Adherence and Retention to Clinical Trials in Special Populations: A Women's Health Initiative Workshop

Workshop Proceedings

Promoting Adherence and Retention to ClinicalTrials in Special Populations: A Women’sHealth Initiative Workshop

Sara Wilcox, PhD, Sally A. Shumaker, PhD,Deborah J. Bowen, PhD, Michelle J. Naughton, PhD,Milagros C. Rosal, PhD, Shari E. Ludlam, MPH,Elizabeth Dugan, PhD, Julie R. Hunt, PhD,and Stephanie Stevens, BSUniversity of South Carolina, Columbia, South Carolina (S.W.), Wake Forest UniversitySchool of Medicine, Winston-Salem, North Carolina (S.A.S., M.J.N., E.D., S.S.), FredHutchinson Cancer Research Center, Seattle, Washington (D.J.B., J.R.H.), University ofMassachusetts Medical School, Worcester, Massachusetts (M.C.R.), and National Heart,Lung, and Blood Institute, Bethesda, Maryland (S.E.L.)

ABSTRACT: This paper describes a Women’s Health Initiative workshop on promoting adher-ence and retention in randomized clinical trials among ethnic minority women, partici-pants of lower socioeconomic status, and older women. Workshop objectives were: (1)to increase knowledge of demographic and cultural characteristics of diverse groups,(2) to increase awareness of how diversity can affect interactions in clinical research, (3) toexplore how research staff behavior can influence adherence and retention, and (4) toincrease knowledge of strategies to enhance adherence and retention in special popula-tions. The workshop emphasized the importance of understanding beliefs, values, andexperiences that are common in diverse groups of individuals, while at the same timerecognizing and respecting individual differences that result from varying life circum-stances and experiences. We discuss strategies to increase cultural competence, reducestereotypes and discrimination, and create a culturally relevant and sensitive researchenvironment. Control Clin Trials 2001;22:279–289 Elsevier Science Inc. 2001

KEY WORDS: Adherence, retention, women, diversity training, ethnicity, race, older adults, socioeco-nomic status, randomized clinical trials

Address reprint requests to: Sara Wilcox, PhD, University of South Carolina, Department of ExerciseScience, Norman J. Arnold School of Public Health, Columbia, SC 29208, USA ([email protected])

Received December 6, 1999; accepted October 27, 2000.

Controlled Clinical Trials 22:279–289 (2001) Elsevier Science Inc. 2001 0197-2456/01/$–see front matter655 Avenue of the Americas, New York, NY 10010 PII S0197-2456(00)00130-6

280 S. Wilcox et al.

INTRODUCTION

Participant adherence and retention are major challenges researchers facewhen conducting randomized clinical trials. These challenges are particularlysalient in large clinical studies that require multiple clinical sites, have complexprotocols (e.g., involve multiple behavioral and pharmacological interventions),and extend over long recruitment and follow-up periods. The emphasis onincluding more representative study participants results in diversity amongboth participants and staff. This diversity creates additional challenges in under-standing cultural differences, study expectations, and the dynamics that evolveamong diverse groups. The Women’s Health Initiative (WHI) is a large, com-plex, long-term investigation of three overlapping randomized clinical trials[1]. The study includes a heterogeneous group of participants and staff, provid-ing an excellent example of the types of adherence and retention challengesfaced by participants and investigators [2]. Within the WHI, investigators andstaff developed a number of strategies to address adherence and retentionchallenges. One strategy is a training workshop on “special populations” toenhance sensitivity to diversity and improve participant adherence and re-tention.

We present a brief overview of the WHI; describe the format, goals, andobjectives of the workshop focused on enhancing adherence and retention toclinical trials among individuals from special populations; and summarize thecontent of the workshop, so that others can replicate it in efforts to enhanceadherence and retention in special populations.

OVERVIEW OF THE WOMEN’S HEALTH INITIATIVE

Clinical Trials and Observational Study

The WHI is a 15-year study (1992–2007) focused on the prevention of themajor causes of morbidity, mortality, and declining quality of life in olderwomen from diverse racial and socioeconomic backgrounds. A total of 161,861women ages 50–79 years at study entry are currently participating in the clinicaltrials (n 5 68,135) and observational study (n 5 93,726) [1–3]. The women wererecruited by 40 clinical centers across the United States.

Special Populations in WHI

Research on women’s health has extraordinary medical, social, and economicimportance and is of personal value to women making decisions about theirhealth care. However, health issues unique to, or more common among, womenhave not been adequately studied [4, 5]. This is especially the case for studiesof chronic diseases in mature women. The WHI is one of the largest long-termstudies ever conducted devoted exclusively to women and their health.

To ensure adequate representation of all women in our society, a majorrecruitment objective of the WHI was to enroll women from diverse culturalbackgrounds, including ethnic minority women and women of lower socioeco-nomic status. Because of the underrepresentation of ethnic minorities in clinicaltrials in the past [5, 6], one goal was to include women from major ethnicgroups proportional to the general population of women ages 50–79 years. TheWHI has an enrollment of nearly 28,000 minority women, including over 14,000

Adherence and Retention in Special Populations 281

African American, 6500 Hispanic, 700 American Indian or Alaskan Native, and4100 Asian or Pacific Islander women. This diversity provides an unprece-dented opportunity to advance knowledge about minority women’s health. Atthe same time, approximately 80% of WHI staff are white, 4% are AfricanAmerican, 9% are Hispanic, 5% are Asian, 1% are Native American, and 1%are of other ethnic groups (based on a survey of the 40 clinical centers, to which29 responded). In addition, 42% of participants have an annual income of lessthan $35,000 and 23% have a high school education or less. Finally, 67% of thewomen in the WHI were over the age of 60 at enrollment, with 22% over theage of 70.

A nationwide study as large as the WHI naturally includes many diversepopulations. In addition to ethnic and age differences, women in the WHI varyon many dimensions: socioeconomic status, including income, education, andoccupation; existence of comorbidities and physical disabilities; prior experi-ence with clinical trial participation; family factors and situations; and urbanversus rural residence. Each of these subgroups has unique perceptions, needs,and concerns. While adherence and retention are difficult in any long-termclinical trial requiring behavior change, promoting adherence and retention inspecial populations may be even more challenging. To address these challenges,we developed a workshop for WHI staff designed to promote adherence andretention in special populations, focusing particularly on issues relevant toethnic minorities. The workshop also covered issues related to adherence andretention among women with low socioeconomic status and older women, butthese issues were covered in less detail.

WORKSHOP FORMAT AND OBJECTIVES

The most common challenges confronting the WHI clinical centers weretransportation, ethnic minority issues, aging and changing life events, multigen-erational issues, income-related issues, psychological issues (e.g., depression),misperceptions about the study by participants, and clinic and research issues.

The workshop’s four major objectives and how we achieved them are asfollows. First, to increase knowledge of demographic and cultural characteris-tics of diverse groups represented in the WHI, we presented demographic dataof WHI participants and staff and highlighted the diversity that exists withinand among these groups. To accomplish the next two objectives, to increaseawareness of how diversity affects interactions with others and to explore howresearch staff behavior can influence adherence and retention, we examinedthe subject of impression formation and how this process influences behaviors.Finally, to increase knowledge of adherence and retention strategies in specialpopulations, our fourth objective, we reviewed effective listening and commu-nication skills, used group brainstorming and role-playing techniques, andencouraged the sharing of adherence and retention strategies currently in useat the clinical centers.

WORKSHOP CURRICULUM

Issues in Diversity

Although individuals from the same ethnic group or race are often viewedas if they are the same or very similar, in fact, within-group differences are


large [7, 8]. For example, the terms “Hispanic” or “Latino” apply to individualswith different cultural traditions, as do the terms “Asian,” “Black,” and “Ameri-can Indian.” In addition to complex differences based on ethnicity alone, differ-ences based on socioeconomic status, level of acculturation, primary languagespoken, and geographic residence within ethnic groups prohibit broad general-izations to an individual from a particular ethnic group [9, 10]. Understandingthe values, beliefs, and customs that are more common to a particular ethnicgroup is helpful, but making assumptions or applying this culture-specificinformation to an individual research participant is problematic and shouldbe avoided [9].

When working with ethnically and culturally diverse participants, it is im-portant to learn how these diverse subgroups fit into the larger society (e.g.,are they immigrants? refugees?) and what the social history of the subgrouphas been [11]. Included is the group’s history in medical research at the localand national levels. Knowledge of the use of experimental medical procedureswith African American slaves [12] and knowledge of the Tuskegee SyphilisExperiment, in which African American men with syphilis were studied butnot treated for 40 years [13], may help one understand an African Americanwoman who is “distrustful” of research and does not want to be a “guinea pig”[14]. This knowledge may also alter how the research protocol is implemented,including providing more details regarding the costs and benefits of participa-tion, providing study results to the community, and providing individual feed-back to the participant [15].

It is often necessary to adapt typical clinical research practices to the culturalviews of each group. For instance, while eye contact is valued in Anglo-Euro-pean Americans, it has different interpretations in other cultures [9]. SomeSoutheast Asian cultures, for example, find direct eye contact unacceptable andaggressive [11], and prolonged eye contact may be considered disrespectful insome Latino cultures [9]. Cultures also differ in their reliance and value placedon verbal communication. For example, Native Americans are more likely tovalue listening skills over verbal skills [11]. Individuals who are Anglo-Euro-pean tend to value precise, direct, and logical verbal communication, whereasAsians, Native Americans, Latinos, and African Americans are more likely toextract meaning from nonverbal communications [9]. Cultures also differ inthe proximity of social distance in which they are comfortable, with Anglo-European Americans and Asians preferring more distance between themselvesand others, and Latinos and African Americans being comfortable with closerconversational distances [9]. In addition, perceptions of time differ by culture.African Americans tend to have a more relaxed and fluid concept of time thando Anglo-European Americans [11]. An example of when cultures may comein conflict is when an African American woman arrives 20 minutes “late” toa study appointment. The research staff may interpret her behavior as “incon-siderate” or as not caring about the study, whereas the participant may simplyhave a different framework of time and may view the study as very important,as evidenced by her keeping her appointment [11]. Other common characteris-tics of diverse cultural groups that may be applicable to clinical research arediscussed in detail elsewhere [16–20].

Perceptions about health, health care, and research also may vary by eth-nicity, and these beliefs can be important determinants of participation in


clinical trials, as well as adherence and retention to the intervention componentsof the trial [21]. For example, religious beliefs, health, and medicine are moreintertwined among Latinos and African Americans as compared with Anglo-European Americans [19, 20]. Native Americans also tend to have holisticand integrated health-care practices and beliefs [10]. Regarding perceptions ofresearch, African American women have been found to have more distrust ofscientists and more negative attitudes toward clinical trials than white women[14, 22], and African American, Native American, and Hispanic adults oftencite “mistrust of being treated like a guinea pig” and “mistrust of white people”as reasons for nonparticipation in [15, 23] or withdrawal from [23] clinical trials.Cultural perceptions, however, must be understood without overgeneralizing,because ethnic groups often incorporate and integrate western medicine withholistic or folk medicine [8, 16, 18–20]. Adherence and retention to the interven-tion are more likely to occur when the research staff works with, rather thanagainst, traditional views of health. Working with traditional views may requirecollaborating with practitioners or care providers who are important to thefamily, such as healers, shamans, medicine men, or priests.

In addition to considering a participant’s ethnicity and associated beliefs andpractices, it is equally important to consider other sociocultural characteristics ofthe individual, including their place of birth, level of acculturation, primarylanguage, age, years of formal education, and family roles and communicationstyles [7, 9, 11]. Finally, there are ways in which systems (e.g., the researchenvironment) can become culturally competent. Elements of a culturally compe-tent system include valuing diversity, having a capacity for cultural self-assess-ment, being conscious of the dynamics inherent when cultures interact, havinginstitutionalized cultural knowledge, and having developed adaptations toresearch that reflect an understanding of cultural diversity [11]. These elementscan be fostered through formal staff training in cultural competence [9, 24].Finally, it is important for participants to enter the research environment and“see themselves” in all aspects of the environment [11]. For example, are therepictures of participants of the same ethnic group, age, and gender? Are therestaff members from their ethnic group? Are the snacks and beverages provideda part of the group’s normal diet? Consultants from the community can bevaluable resources in ensuring a culturally sensitive environment.

Impression Formation

In addition to understanding the history, beliefs, and values of differentgroups, it can also be useful to understand how impressions about groups ofpeople are formed and recognized, how these impressions impact attitudesand behavior, and how these impressions can potentially be modified [25].Prior to understanding how impressions of diverse others are formed, severalterms must be defined. Traditionally, “stereotypes” are defined as beliefs andexpectations about members of social groups [26]. “Prejudice,” on the otherhand, is a biased affective reaction, either positive or negative, to an individualperson that is based on that person’s membership in a given social group [26].“Discrimination” is different from prejudice in that it is a biased behavior towardanother individual based on that person’s membership in a given social group[26]. Not all discrimination, however, is observable and biases can be either


explicit or implicit. In fact, implicit biases appear to be more common in ourculture [25, 26].

Social psychologists describe a process by which individuals form impres-sions of others, and how these impressions impact subsequent interactions.The first stage in this process is categorization, an automatic process in whichwe organize or sort things or people to simplify a complex world [27]. Forexample, we learn that objects with a seat and four legs are “chairs” even thoughchairs vary in terms of shape, size, and color. Related to the categorization ofpeople, one of our workshop speakers asked all participants to draw a pictureof a “Texan” to demonstrate how common stereotypes are and how easily theyare elicited. Common stereotypes elicited were that Texans wore cowboy hatsand boots, had a horse, and ate steak. Not only is categorization an automaticprocess, but decades of research in social psychology indicate that people tendto like others who they perceive as similar to themselves and are less likely tostereotype those who are perceived as similar [25]. The second stage of impres-sion formation, interpretation, relates to gathering information about others.The third stage, response, concerns how we respond to others based on informa-tion we gather. To illustrate these last two stages in the workshop, participantswere divided into groups and each member wore a headband with a differentattribute printed on it. The individual wearing the headband did not knowwhat her/his attribute was, but it was visible to all other members of the group.Participants were asked to respond to each individual in a manner consistentwith the attribute on the headband. Examples of attributes were “I have bodyodor” and “I don’t understand English.” The concept of a self-fulfilling proph-ecy was introduced and defined as expectations and beliefs about others thatcause us to behave in ways that, in turn, lead these people to confirm ourbeliefs [28]. An example applied to clinical trials would be “expecting” membersof a particular ethnic or age group to be unable to follow a study protocol, whichcould lead to lower performance by that group member—thereby fulfilling thestaff’s assumptions.

Factors that promote bias include motivations such as power or the desireto maintain prior beliefs, time constraints, lack of accountability to self or others,and being the only member of a particular group [25, 29, 30]. Power and timeconstraints may be particularly relevant in clinical trials. The research staffmember, particularly one fulfilling a clinical research role, is likely the higher-status individual in a participant-staff dyad. Evidence shows that people payattention to those in power and attempt to gather more information aboutthese individuals because those in power can control various outcomes [30].However, those in power are less likely and less motivated to try to gatherinformation about individuals with less power, often resulting in the relianceon stereotypes. Similarly, when staff members are pressed for time, as is oftenthe case in clinical trials research, they are more likely to rely on stereotypes,which is a more efficient, although inherently flawed, strategy. There are anumber of strategies that can be used in clinical research and other settings toreduce bias. Attempting to suppress stereotypes is not an effective strategybecause it is not only difficult, but can actually lead to a rebound (increase) instereotypical thoughts [31]. Rather, research suggests that biases may be re-duced when individuals internalize egalitarian values, are aware of violationsof these values, experience guilt when values are violated, make efforts to


change their behavior, practice these changes, and eventually develop newautomatic responses [25, 29]. There are also systemwide policies to reduce bias,including encouraging a discussion of these issues and not tolerating smallinfractions (e.g., jokes around the clinic based on gender, age, or race) [25].

Understanding Cultural Differences in Clinical Trials

As alluded to earlier, adherence can be impacted not only by ethnicity, butalso by other participant characteristics, including age, gender, and socioeco-nomic status. Five “cultures” that should be considered in clinical trials, particu-larly clinical trials with older women, include feminine, school, poverty, genera-tional, and ethnic/racial cultures [32].

An important aspect of the “feminine culture” that can impact participationin clinical trials relates to family dynamics. Multiple family roles can imposestress and burden that may interfere with research participation. Similarly,social norms regarding what it means to be a woman often dictate expectationsand subsequent behavior, which can impact the completion of study require-ments [32]. For example, a woman who holds more traditional beliefs may bereluctant to cook low-fat foods, as dictated by the research protocol, if herfamily does not like these foods. Similarly, participating in a research trial maytake away time from family obligations, such as caring for grandchildren orolder parents, which are seen as primary.

Participation in clinical trials often requires skills that are usually learnedin the school setting, that is, a “school culture,” such as self-discipline, observingand reporting events, setting long-term goals, reading and completing forms,and using Likert-type scales [32]. Participants who lack these skills, have lowlevels of literacy, or have less literacy in the English language might findparticipation in clinical trials very demanding and stressful. At the same time,they may be reluctant to discuss their experience directly and may drop outof the study for “unknown” reasons.

The “poverty culture” can come in conflict with research participation whenthe day-to-day orientation of living, competing priorities, and the focus on thecommunity are more central than individual needs or study requirements [32].For example, a single-parent woman who works full-time and is the primarycaretaker of children and an adult parent may struggle to see the value ofparticipation in a research trial, particularly when participation conflicts withthe responsibilities dictated by her other roles. Similarly, participants who haveconcerns about their ability to pay rent and provide food for their family maynot see the value of a health promotion trial.

“Generational or age culture” consists of traditions, personal history, andall too often, disability [32]. Age-associated changes in health status can impactthe ability of an older adult to drive independently or use public transportation,which can impinge on participation in a clinical trial. These factors are morelikely to operate in studies that require multiple years of follow-up, such asthe WHI. In addition, traditional beliefs may conflict with current medicalfindings, which may impact enrollment and adherence to a trial. The constraintsthat typically occur within clinical research can also interfere with the ability ortime research staff has to listen to the participant’s personal history, negativelyimpacting adherence or retention in a trial.


Finally, “cultures of ethnicity and race” consist of community, language/communication, and beliefs. In this context, community relates to family ar-rangements, social conventions, and social support, and how these norms maycome into conflict with the norms of the research study [32]. Language/commu-nication barriers might also occur due to literacy and English proficiency issues,as well as verbal and nonverbal patterns of communication. Beliefs, such asthe understanding of illness, beliefs regarding medication intake, spiritual be-liefs, and beliefs about research, as discussed earlier, can also interact to ad-versely affect participation and adherence to clinical trials, particularly whenthese beliefs are not considered or valued.

Motivation is an important factor in research participation, and the perceivedbenefits (e.g., health care, social support, social recognition) and tangible bene-fits (e.g., health monitoring, information, incentives) of participation can operateto influence adherence and retention [32]. Perceived benefits can be maximizedby providing health information and feedback to participants, encouraginggroup thinking, providing the opportunity for social recognition, and being anadvocate for participants [32].

Basics of Communication and Listening Skills

Effective listening and communication skills are central to interacting withparticipants from all backgrounds. Adhering to a complex research protocolover a long period of time often requires a compromise between the participantand the clinical research staff. This compromise can be achieved through threestages that are central to effective communication: (1) assessing, (2) negotiatingand motivating, and (3) assisting and arranging [33, 34]. During the assessmentphase, the interviewer or interventionist attempts to better understand thesituation or problem. This is accomplished by attending to both the verbal andnonverbal behavior of the participant [24], by avoiding outside distractions,and by communicating “openness” to the participant’s issues or concerns.Active listening [33, 34] can be used to express openness to participants. Thisskill requires attending to verbal and nonverbal communication, reflecting andamplifying the participant’s words or behaviors, and responding and probingthrough empathizing with the participant, testing hypotheses about the partici-pant’s barriers to adherence, and eventually clarifying the problem and thebarriers with the participant.

Strategies for negotiating/motivating are important in studies such as theWHI, particularly when the study goals may conflict with the participant’spersonal goals. First, the issue or problem must be introduced and feedbackis then given to provide a feeling of dissonance with the participant (e.g., “Thegoal for this study is to take your study pill every morning and evening. Youhave indicated, however, that it is difficult for you to take your evening pill,so you are only taking half of your study pills.”). Next, the issue or problemis further explored by emphasizing choices or options (preferably generatedby the participant), exploring ambivalence, clarifying participant values, andaccepting rather than fighting resistance.

In the final stage, the goals of the research staff are to facilitate participantdecision making, offer advice and support, and assist the participant in devel-oping a realistic and workable plan to increase their study adherence and


participation. In all stages of negotiation, cultural factors must be consideredand explored, and reaching a compromise is often the end goal [35].

SUMMARY AND CONCLUSIONS

Large, complex, randomized clinical trials with diverse staff and participantpopulations present unique adherence and retention challenges. While moreis known about barriers to recruiting ethnic minorities and other special popula-tions into clinical trials and strategies to overcome these barriers [23, 36–39],far less is known about factors influencing adherence and retention in thesegroups. The WHI investigators and staff have implemented a number of strate-gies to optimize adherence and retention in this long-term study. These include:careful data monitoring and timely feedback to clinical centers on adherenceand retention criteria; intensive staff training in interviewing techniques; clinic-specific in-services in such areas as diversity training, bereavement, depression,and staff burnout; centralized and on-site staff training sessions; and centralizedtopic-specific workshops.

In this paper we addressed the challenges associated with large and diverseparticipant and staff populations. We emphasized the development of culturalcompetence and sensitivity to diversity by discussing values and beliefs morecommon in persons from diverse cultural backgrounds, emphasized heteroge-neity within groups, and highlighted the role of sociodemographic characteris-tics that often intersect and interact with ethnicity [11]. The development ofimpressions of others, how these impressions are maintained and altered, andstrategies to alter stereotypes, prejudice, and discrimination were presented[25]. Finally, the role of sociocultural factors such as gender, education, poverty,age, and ethnicity were explored in greater detail as they may relate to adher-ence in clinical trials [32].

As clinical study populations become increasingly diverse, we recommendthat investigators consider holding diversity training and interviewing-skillstraining at study outset, and, depending on the length of the study, hold“refresher” didactic sessions that include explicit examples of challenges facedwithin clinics and methods for addressing such challenges.

We would like to sincerely thank our guest speakers, Stephanie Goodwin, PhD (Boston College,Chestnut Hill, MA; currently at Yale University, New Haven, CT), Suzanne Randolph, PhD (Univer-sity of Maryland, College Park, MD), and Perla A. Vargas, PhD (Johns Hopkins University, Balti-more, MD; currently at the University of Arkansas for Medical Sciences, Little Rock, AK) for theirvaluable contributions. The preparation of this manuscript was supported, in part, by the Women’sHealth Initiative through a contract from the National Institutes of Health (NHLBI contract #N01-WH-2-2110). The Workshop was funded by the National Heart, Lung, and Blood Institute.

AUTHORS’ NOTE

Members of the Special Populations Workshop Task Force were, in alphabeti-cal order by institution: Deborah J. Bowen, PhD, Barbara Cochrane, RN, PhD,and Julie R. Hunt, PhD, from the Fred Hutchinson Cancer Research Center,Seattle, WA; Shari Eason Ludlam, MPH, and Linda Pottern, PhD, from theNational Heart, Lung, and Blood Institute, Bethesda, MD; Joanice Thompson,


from the University of Alabama, Birmingham, AL; Judith K. Ockene, PhD, andMilagros C. Rosal, PhD, from the University of Massachusetts Medical School,Worcester, MA; Elizabeth Dugan, PhD, Michelle J. Naughton, PhD, ElectraPaskett, PhD, Sally A. Shumaker, PhD, Stephanie Stevens, BS, and Sara Wilcox,PhD, from the Wake Forest University School of Medicine, Winston-Salem, NC(S.W. currently at the University of South Carolina, Columbia, SC). Dr. SallyShumaker chaired the Special Populations Task Force.

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Promoting Adherence and Retention to Clinical Trials in Special Populations: A Women's Health Initiative Workshop