Research Toni Tripp-Reimer, RN, PhD, FAAN, Bradley Doebbeling, MD, MS ABSTRACT The rapid uptake of qualitative approaches in translational research can be best understood in the context of recent innovations in health services research, as well as an overarching concern with improving the quality of health care. Qualitative approaches highlight the human dimension in health care by foregrounding the perceptions, experiences, and behaviors of both consumers and providers of care. As such, these methods are particularly useful for addressing the complex issues related to improving health care quality and implementing system change. This overview traces a brief history of the factors contributing to the recent and rapid growth of qualitative methods in health research in general and translational research in particular; describes the varieties of qualitative approaches employed in this research; and illustrates the utility of these approaches for variable identification, instrument development, description/explanation of patient/provider perceptions and behaviors, individual/organizational change, and theory refinement. Worldviews on Evidence-Based Nursing 2004; 1(S1):S65S72. Copyright 2004 Sigma Theta Tau International KEYWORDS qualitative methods, naturalistic inquiry, qualitative synthesis, translational research, evidence- based practice, patient experience, provider behavior, theory construction, Cochrane Qualitative Methods Group INTRODUCTION W hile qualitative approaches in research have been increasingly recognized as providing distinct and significant contributions in health research for the past 40 years, they have received unprecedented emphasis in the past 5 years. The rapid uptake of qualita- tive approaches in translational research can be best under- stood in the context of recent innovations in health services research, as well as an overarching concern with improv- ing the quality of health care. Qualitative approaches high- light the human dimension in health care by foregrounding Toni Tripp-Reimer, Professor and Associate Dean for Research, The University of Iowa, College of Nursing, Bradley Doebbeling, General Internal Medicine Professorship in Health Services Research, Indiana University School of Medicine; Associate Director for Health Services Research, Regenstrief Institute for Health Care; Director, Health Services Research Service (11-H), Roudebush VA Medical Center, Indianapolis, IN 46202, USA. Address correspondence to Toni Tripp-Reimer, Professor and Associate Dean for Research, The Univercity of Iowa, College of Nursing, 50 Newton Road, Iowa City, IA 52242, USA; toni-reimer@uiowa.edu This article was presented at the U.S. Invitational Conference Advancing Quality Care Through Translation Research, October 1314, 2003, at the University of Iowa, Iowa City, Iowa. Copyright 2004 Sigma Theta Tau International 1545-102X1/04 the perceptions, experiences, and behaviors of both con- sumers and providers of care. As such, these methods are particularly useful for addressing the complex issues re- lated to improving health care quality and implementing system change. Qualitative research offers a variety of methods for identifying what really matters to patients and [providers], detecting obstacles to changing performance, and explaining why improvement does or does not occur (Pope, vanRoyen&Baker 2002, p. 148). This overviewwill trace a brief history of the factors contributing to the recent and rapid growth of qualitative methods in health research in general and translation research in particular; describe the varieties of qualitative approaches employed in this re- search; and illustrate the utility of these approaches for variable identification, instrument development, descrip- tion/explanation of patient/provider perceptions and be- haviors, as well as individual/organizational change. HISTORICAL OVERVIEW Qualitative approaches in translational research need to be understood within the broader context of the recent uptake of qualitative methods in health services research. Qualita- tive approaches inhealth-related researchwere first used by Worldviews on Evidence-Based Nursing r Third Quarter (Suppl.) 2004 S65 Qualitative Perspectives in Translational Research anthropologists conducting ethnographies in remote cul- tures (Rivers 1924; Evans-Pritchard 1937). Later sociol- ogists adapted observational techniques to study aspects of the biomedical health system (Becker, Geer, Hughes & Strauss 1961; Goffman 1961, 1963). Nursing was the first health discipline to identify the importance of qualitative methods, legitimize them, and incorporate them into re- search. Over the past decade, and particularly in the past 5 years, there has been an exponential increase in the use of qualitative approaches in health services and translational research. Federal, national, and international agencies and ini- tiatives have facilitated this evolution through a variety of mechanisms such as conferences and reports. Two fed- eral funding agencies in the United Statesthe National Institutes of Health (NIH) and Agency for Health Re- search and Quality (AHRQ)have promoted qualitative approaches througha series of developmental/training con- ferences and calls for applications. In 1998, the Agency for Health Care Policy and Research (now AHRQ) and The Robert Wood Johnson Foundation co-sponsored a ground- breaking conference titled Qualitative Methods in Health Services Research in Rockville, Maryland, with 78 in- vited participants from health services research and social science (http://www.ahcpr.gov/about/cods/codsqual.htm). These proceedings were subsequently published in the journal Health Services Research (Devers, Sofaer & Rundall 1999). In1999, a workshop of social scientists organized by the National Institute for Mental Health and the National Institute on Alcohol Abuse and Alcoholism resulted in the guide Qualitative Methods in Health Research: Opportu- nities and Considerations in Application and Review for investigators using qualitative approaches http://obssr.od. nih.gov/Publications/Qualitative.PDF. Shortly thereafter, in 2002, NIH sponsored the conference Using Quali- tative Methods to Promote Self-Care in Diverse Popu- lations (http://obssr.od.nih.gov/Conf Wkshp/Adherence /Qualitative Methods.htm). A final example is the 2004 NIH conference The Design and Conduct of Qualitative and Mixed-Method Research sponsored by the Office of the Director, Office of Behavioral and Social Science Re- search (http://obssr.od.nih.gov/conf wkshp/sw/). Publications in health literature reflect these develop- ments. While nursing science journals have published qualitative studies since the 1952 inaugural issue of Nurs- ing Research, medical and health research journals have only more recently incorporated such studies. In the past decade, a series of editorials in prominent medi- cal journals, particularly the British Journal of Medicine and to a lesser extent the Journal of the American Medi- cal Association, have highlighted the importance of qual- itative approaches. Similarly, the National Institute of Medicine issued a series of reports specifically calling for increased use of qualitative approaches in health research: r Priority Areas for National Action: Transforming Health Care Quality (Adams & Corrigan 2003) r Leadership by Example: Coordinating Government Roles in Improving Health Care Quality (Corrigan, Eden & Smith 2002) r Who Will Keep the Public Healthy? Educating Pub- lic Health Professionals for the 21st Century (Gebbie, Rosenstock & Hernandez 2003) r Speaking of Health: Assessing Health Communica- tion Strategies for Diverse Populations (Institute of Medicine 2002) r Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care (Smedley, Stith & Nelson 2003) r Crossing the Quality Chasm: A New Health System for the 21st Century (Institute of Medicine 2001) r Promoting Health: Intervention Strategies from Social and Behavioral Research (Smedley & Syme 2000) The British-based International Cochrane Collabora- tion prepares, maintains, and disseminates systematic re- views. In 2001, the Qualitative Methods Group was of- ficially registered as an active component of the overall Cochrane Collaboration in partnership with the Camp- bell Process Implementation Methods Group. The goals of the Cochrane Qualitative Methods Group are to (a) demonstrate the value of qualitative research through systematic reviews, (b) disseminate methodological stan- dards to aid the evaluation of qualitative research, (c) promote the synthesis and integration of qualita- tive research within the broader literature syntheses, and (d) provide some training in qualitative methods syn- thesis: (http://www.lancs.ac.uk/depts/ihr/research/public /cochrane.htm). This recent and rapidly increasing attention and activity have been triggered by several sources including increasing healthcare costs, increasing healthdisparities, unexplained practice variation, the increased role of the consumer voice, the complexity of clinical decision making, and the recog- nition that practice changes are not driven solely by sci- entific knowledge (Jones 1995; Popay, Rogers & Williams 1998; Shortell 1999; Pope, van Royen & Baker 2002). For example, the recent, but dramatic, emergence of patient- centered initiatives, such as the Picker/Commonwealth Program for Patient-Centered Care approach, mandate at- tention be given to topics such as respect for patient values, preferences, and needs that are best identified and under- stood through qualitative approaches. Shortell (1999) views the growing role of qualitative ap- proaches in translation research as reflecting the need for a more in depth (sic) understanding of naturalistic settings, S66 Third Quarter (Suppl.) 2004 r Worldviews on Evidence-Based Nursing Qualitative Perspectives in Translational Research the importance of understanding context, and the com- plexity of implementing social change (p. 1083). Corre- spondingly, the greater appreciation of qualitative methods can be traced to the growing recognition that many health problems and processes of care do not fit easily into exper- imental research designs (Popay, Rogers & Williams 1998, p. 341). NATURE OF QUALITATIVE APPROACHES While in a literal sense, qualitative methods include all modes of inquiry that do not use statistical methods; the term is actually a misnomer. The terms qualitative and quantitative actually refer to forms of data, not to forms of design. More accurately, qualitative and quantitative data are generally collected through naturalistic and positivis- tic designs, respectively. Further, both forms of data come from empirical sources. Naturalistic inquiry encompasses a wide array of both primary and secondary research modes, which differ in their depth of focus and degree of interpretation. Primary modes have greater depth and interpretative level and are represented most commonly by ethnography, grounded theory, and phenomenology, but also include ethology, ethnomethodology, hermeneutics, oral/life histories, dis- course analysis, and critical and historical approaches to inquiry. Each primary tradition has a distinct set of foun- dational philosophical and theoretical orientations, strate- gies for data collection and analysis, and forms of research products. Secondary modes of naturalistic inquiry gener- ally elicit more superficial-level data for categoric (descrip- tive rather than interpretive) analysis; common types in- clude focus groups, critical incident technique, case study methodology, ethnoscience, and open, free-text responses. The selection of a particular naturalistic approach de- pends on the purpose of the research. For example, phe- nomenology is the method of choice when the purpose is to understand the meaning of the lived experience of a given phenomenon for informants; grounded theory is selected to uncover/understand basic social processes; and ethnog- raphy is selected to understand patterns and/or processes grounded in culture. In most forms of naturalistic inquiry, investigators typ- ically use one or a combination of strategies including participant observation, informant interviews, and docu- ment analysis. However, the extent to which the inves- tigator relies on any one strategy will vary; for example, phenomenology relies primarily on informant interviews, ethnography has a more even balance between participant observationand interviewing, and ethology relies primarily on observations (Tripp-Reimer & Kelley 1998). In summary, naturalistic inquiry most commonly occurs in field settings with investigators collecting data through participant observation and unstructured interviews, and analyzing data through thematic content analysis. USES OF QUALITATIVE APPROACHES IN HEALTH RESEARCH Qualitative approaches may be employed for a wide va- riety of purposes related to health services and transla- tional research. Five specific topics are addressed below ranging fromvariable identificationto instrumentation, de- scription/understanding of lay and provider behaviors, the- ory construction/refinement, and synthesis for developing practice guidelines. Variable Identication At the most foundational level, qualitative approaches are often used to clarify concepts and constructs, and to or- der them vertically and horizontally in the form of tax- onomies. These standardized languages and classification systems commonly form the basis for effective research us- ing large datasets. Two nursing standardized languages, the Nursing Interventions Classification (NIC; Dochterman & Bulechek 2004) and the Nursing Outcomes Classification (NOC; Moorhead, Johnson & Maas 2004) were developed at the University of Iowa using the ethnoscience approach. Further, Kuzel et al. (2003) demonstrated the utility of this approach for constructing typologies of errors experienced by patients and contrasting them with that of physicians; they found that most technical definitions fail to capture many types of errors of greatest concern to patients. Instrumentation Qualitative approaches are often used to develop or refine data collection instruments. Prior to instrument construc- tion, interviews (either individual or group) are commonly used to establish content domains and generate specific items. After instrument construction, these same methods, as well as formal cognitive interviews, may be used to as- sess the adequacy of the instruments or to understand re- sponse difficulties and variations. For example, while qual- itative approaches were used in the initial development of the Picker (adapted from the Picker-Commonwealth Sur- vey of Patient-Centered Care) and Consumer Assessment of Health Plans Survey (Adult) (CAHPS 2.0) instruments, they were also employed in later evaluations of their suit- ability for different populations. Ngo-Metzger et al. (2003) identified important aspects of the quality of care for Chi- nese and Vietnamese immigrants not included in these in- struments. Important missing domains in the Picker and CAHPS instruments included (a) provider respect for tradi- tional healthbeliefs andpractices, (b) access toprofessional Worldviews on Evidence-Based Nursing r Third Quarter (Suppl.) 2004 S67 Qualitative Perspectives in Translational Research interpreters (and quality of interpreters), and (c) assistance in obtaining social services. Description/Understanding Phenomena Perhaps the most frequent use of qualitative approaches is for understanding the phenomena that are context depen- dent. Broad domains include understanding patient and provider perceptions and behaviors, as well as the process of individual and organizational change. Patient Experiences and Behaviors Hundreds of qualitative studies have been conducted to describe and understand patient experiences, preferences, needs, and satisfaction. Projects have described what it is like to live with a specific illness such as headache (Peters, Abu-Saad, Vydelingum & Murphy 2002) or cystic fibro- sis (Gjengedal, Rustoen, Wahl & Hanestad 2003); how the context of care affects experiences such as dying (Mur- ray, Grant, Grant & Kendall 2003) or self-reliance with sickle cell disease (Maxwell, Streetly & Bevan 1999); how perceived needs (Detaille, Haafkens & van Dijk 2003) or quality-of-care domains (Curtis et al. 2002) differ across different groups of chronically ill patients. Evans (2002, p. 290) points out how these studies provide a strategy to give consumers a voice in clinical decision making through documenting their experiences, preferences, and priorities. Studies of patient behaviors have provided important insights regarding the basis for specific patient behaviors including patterns of service utilization (Kelly & Groff 2000), the logic of noncompliance (Trostle 1997), and vari- ation in triggers and barriers to change for various health- related behaviors (Currie, Amos & Hung 1991). Power (2002) points out howqualitative approaches have demon- strated utility in areas where the social phenomena may be highly personal, sensitive, and sometimes illicit, as with much of HIV/AIDS research where these methods have greatly increased our understanding of cultural influences on lifestyles, risk negotiation around sex and drug inject- ing, and health or identity disclosures. Provider Perspectives and Behaviors While provider behaviors have been a relatively recent fo- cus oninquiry, this is a rapidly developing area andincludes domains related to interaction/communication, provider behavior, and the process of clinical decision making. Stud- ies of interaction/communication have contributed to our understanding of the ways providers strategically estab- lish and maintain unequal power relations (Rapp 1988) and how the different realities of providers and patients re- sult inmiscommunicationandmisunderstandings (Cohen, Tripp-Reimer, Smith, Sorofman & Lively 1994; Green & Britten 1998; Gjengedal et al. 2003). Several descriptive studies have investigated provider- prescribing behavior related to pain management (Rogers 2002) or antibiotic use (Walker, McGeer, Simor, Armstrong-Evans & Loeb 2000; Radyowijati & Haak 2003). These have clear implications for planning interven- tions to alter provider behavior in translational research. Changing Provider Behavior and Health Systems A number of studies have investigated the phenomena of practice change, particularly noting barriers to change. Many barriers are based on providers perceptions of pa- tient views, preferences, or characteristics. Patients views of their own illness may affect their compliance (Green & Britten 1998) or their preferences for treatment. For ex- ample, an investigation of unnecessary antibiotic prescrib- ing indicated that providers actions relied more heavily on their views of patient preferences for antibiotics than on their own knowledge of scientific recommendations (Butler, Rollnick, Pill, Maggs-Rapport & Stott 1998); they suggested that greater practice change would result from interventions targeting clinical interactions rather than education. Patient characteristics also may influence ap- plication of practice guidelines. An investigation of low adherence to hypertension practice protocols for geri- atric patients found that providers viewed their patients other problems as more significant and were also con- cerned about the greater likelihood of adverse effects of medications in elders (Cranney, Warren, Barton, Gardner & Walley 2001). Other studies have targeted the ways in which organiza- tional context and professional environment affect use of practice protocols. For example, available time and level of expertise affected how residents obtained evidence for clinical decision making (Montori, Tabini &Ebbert 2002). Similarly, local provider culture was shown to create a local consensus of practice knowledge that strongly influenced the interpretation and weighting of newscientific evidence (Fairhurst & Huby 1998). A few studies have specifically focused on strategies for guideline implementation, such as use of ward rounds (Deshpande, Publicover, Gee & Khan 2003). Other ap- proaches have examined how different groups of stake- holders vary in their uptake of practice guidelines. Allery, Owen, and Robling (1997) used critical incident technique to explore how general practitioners and specialists dif- fer in triggers and sources of evidence underlying prac- tice changes. Using Giorgis phenomenological method, Andersen (2002) examined important differences in bar- riers to implementing a medication tracking system as ex- perienced by nurse managers and physicians. In perhaps the most comprehensive study of barriers and facilitators to guideline implementation, Doebbeling et al. (2002)conducted 50 focus groups with three categories of stakeholders (administrators, primary care providers, and clinicians) at 20 Veterans Affairs Medical Centers in S68 Third Quarter (Suppl.) 2004 r Worldviews on Evidence-Based Nursing Qualitative Perspectives in Translational Research the United States. Annually, the Veterans Health Adminis- tration rolls out different clinical practice guidelines and monitors compliance with them, making this an excellent environment for translational science. Perceived major fa- cilitators to guideline implementation included admin- istrative commitment, electronic patient records, work reorganization, and audit with feedback. Major barriers included time and workload issues, lack of technologi- cal support, and lack of guideline credibility. Providers (primarily physicians) and clinicians (primarily nurses) emphasized barriers and problems with clinical prac- tice guidelines, while administrators emphasized guideline benefits andfacilitators to implementation. The groups also differed in the major concerns expressed: Administrators emphasized guideline compliance; providers emphasized continuity of care; and clinicians emphasized benefits for patients (Doebbeling et al. 2002; Sorofman et al. 2002; Vaughn et al. 2002; Lyons et al. 2003). Taken as a whole, these studies illustrate that implementing effective organi- zational change requires attention to the issues of each key stakeholder group. Theory Construction/Renement Qualitative approaches are not only useful for generat- ing hypotheses, but also for theory development and re- finement. An illustration of this point was made by the Doebbeling et al. (2002) team investigating barriers and facilitators to clinical practice guideline implementation in the VHA. After completing the qualitative data analysis from the 50 focus groups, they mapped the codes to the framework developed by Kitson, Harvey, and McCormack (1998) to depict implementation of clinical practice guidelines. The model by Kitson et al. contains three major domains: evidence (research, clinical experience, and patient preferences), context (culture, leadership, and measurement), and facilitation (characteristics, role, and style). Recommendations for refinement of the Kit- son model included adding guideline characteristics to the evidence domain, deleting measurement from and adding organizational characteristics to the context do- main, and adding implementation strategies/processes to the facilitation domain (Tripp-Reimer & Doebbeling 2003). In summary, the naturalistic and qualitative approaches are escalating in use and importance in all health research and are increasingly important in translational INTEGRATING QUALITATIVE RESEARCH INTO SYNTHESIZED EVIDENCE REPORTS In translational research, there have been several re- cent, but highly significant, events and activities pro- moting and facilitating the incorporation of the results of naturalistic studies into synthesized evidence reports (e.g., clinical practice guidelines). In Britain, the Na- tional Health Service Center for Reviews and Dissem- ination called for the inclusion of qualitative data in its syntheses, and the Cochrane Qualitative Group has been responsive to this mandate. The University of Es- sex established a qualitative dataset of patient responses that is now a part of the Economic and Social Data Services (ESDS) Qualidata that is in the public domain (http://www.esds.ac.uk/qualidata/online); a second estab- lished resource, DIPEx, contains a large set of interviews describing patient experiences that may be used by clini- cians, instructors, or investigators (http://www.dipex.org). The utility of qualitative data in systematic reviews can be demonstrated through a delineation of the several roles it can play including (a) clarifying the focus of the review; (b) identifying the relevant types of participants, interven- tions, and outcomes; (c) providing data for a qualitative synthesis; (d) explaining unexpected findings of quantita- tive studies; (e) interpreting the significance and applica- bility of the review; and (f) suggesting bothclinical and pol- icy recommendations for implementation (Dixon-Woods, Fitzpatrick & Roberts 2001). Four major approaches have been proposed for the systematic synthesis of qualitative data. The first two approachesthe Case Survey Method (Yin & Heald 1975) and the Qualitative Comparative Method (Ragin 1987) translate the qualitative data into numerical data, and then analyze those data using statistics. The two newer ap- proaches retain the qualitative character of the data and are termed meta-ethnography (Noblit & Hare 1988) and meta- synthesis (Sandelowski, Docherty & Emden 1997; Thorne et al. 2002; Finfgeld 2003; Sandelowski & Barroso 2003) and were developed by anthropologists and nurse scien- tists, respectively. Despite the recognized utility of qualitative data for syn- thesis in practice guidelines, there are several problems with the operationalization of this plan. Not the least of the concerns involves difficulties in conducting literature searches for the qualitative studies, including the frequent use of witty or obscure titles, lack of standardized terms inabstracts, andvariationinindexing across the wide range of journals (Cesario, Morin & Santa-Donato 2002; Evans 2002; Hawker, Payne, Kerr, Hardey & Powell 2002; Bar- roso et al. 2003). Furthermore, there is variation in eval- uating both the quality (rigor) and the level of evidence of the results, although several recent strategies have been put forth (Popay, Rogers & Williams 1998; Giacomini & Cook 2000a, 2000b; Cesario, Morin &Santa-Donato 2002; Fossey, Harvey, McDermott & Davidson 2002; Hawker, Payne, Kerr, Hardey & Powell 2002). While there is yet no consensus regarding the best approach for qualitative data synthesis, the Cochrane Qualitative Group is making Worldviews on Evidence-Based Nursing r Third Quarter (Suppl.) 2004 S69 Qualitative Perspectives in Translational Research excellent progress in formulating such recommendations, as are individual scientists such as Greenhalgh (2002). SUMMARY The unprecedented proliferation of qualitative research in health sciences can be attributed to an increased empha- sis on the components of quality of care and a mandate to ensure that health care decisions are made on the best available evidence. In the context of health research in general, and translational research in particular, qualita- tive approaches are making distinct and important contri- butions through the illuminating and explanatory power of these forms of evidence. 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