Liver Transplant Research Paper

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18. Raia S, Nery JR, Mies S. Liver transplantation from live donors. Lancet. 1989;2:497.[PubMed]

19. Strong RW, Lynch SV, Ong TH, Matsunami H, Koido Y, Balderson GA. Successful liver transplantation from a living donor to her son. N Engl J Med. 1990;322:1505–1507.[PubMed]

20. Sass DA, Reich DJ. Liver transplantation in the 21st century: expanding the donor options. Gastroenterol Clin North Am. 2011;40:641–658.[PubMed]

21. Welch CS. A note on transplantation of the whole liver in dogs. Transpl Bull. 1955;2:54–55.

22. Cannon JA. Brief report. Transpl Bull. 1956;3:7.

23. Denmark SW, Shaw BW Jr, Starzl TE, Griffith BP. Veno-venous bypass without systemic anticoagulation in canine and human liver transplantation. Surg Forum. 1983;34:380–382.[PMC free article][PubMed]

24. Shaw BW, Martin DJ, Marquez JM, Kang YG, Bugbee AC, Iwatsuki S, Griffith BP, Hardesty RL, Bahnson HT, Starzl TE. Venous bypass in clinical liver transplantation. Ann Surg. 1984;200:524–534.[PMC free article][PubMed]

25. Griffith BP, Shaw BW, Hardesty RL, Iwatsuki S, Bahnson HT, Starzl TE. Veno-venous bypass without systemic anticoagulation for transplantation of the human liver. Surg Gynecol Obstet. 1985;160:270–272.[PMC free article][PubMed]

26. Tzakis A, Todo S, Starzl TE. Orthotopic liver transplantation with preservation of the inferior vena cava. Ann Surg. 1989;210:649–652.[PMC free article][PubMed]

27. Stieber AC. One surgeon’s experience with the piggyback versus the standard technique in orthotopic liver transplantation: is one better than the other? Hepatogastroenterology. 1995;42:403–405.[PubMed]

28. Parrilla P, Sánchez-Bueno F, Figueras J, Jaurrieta E, Mir J, Margarit C, Lázaro J, Herrera L, Gomez-Fleitas M, Varo E, et al. Analysis of the complications of the piggy-back technique in 1112 liver transplants. Transplant Proc. 1999;31:2388–2389.[PubMed]

29. Brostoff JM, Bhati CS, Syn WK. Late venous outflow obstruction after liver transplant: The ‘piggy-back’ syndrome. Eur J Intern Med. 2008;19:374–376.[PubMed]

30. Gurusamy KS, Pamecha V, Davidson BR. Piggy-back graft for liver transplantation. Cochrane Database Syst Rev. 2011;(1):CD008258.[PubMed]

31. Couinaud C. Le foie: etudes anatomiques et chirurgicales. 1. Paris: Masson et Cie; 1957.

32. Bismuth H. Surgical anatomy and anatomical surgery of the liver. World J Surg. 1982;6:3–9.[PubMed]

33. Emond JC, Whitington PF, Thistlethwaite JR, Cherqui D, Alonso EA, Woodle IS, Vogelbach P, Busse-Henry SM, Zucker AR, Broelsch CE. Transplantation of two patients with one liver. Analysis of a preliminary experience with ‘split-liver’ grafting. Ann Surg. 1990;212:14–22.[PMC free article][PubMed]

34. Vagefi PA, Parekh J, Ascher NL, Roberts JP, Freise CE. Outcomes with split liver transplantation in 106 recipients: the University of California, San Francisco, experience from 1993 to 2010. Arch Surg. 2011;146:1052–1059.[PubMed]

35. Doyle MB, Maynard E, Lin Y, Vachharajani N, Shenoy S, Anderson C, Earl M, Lowell JA, Chapman WC. Outcomes with split liver transplantation are equivalent to those with whole organ transplantation. J Am Coll Surg. 2013;217:102–112; discussion 113-114.[PubMed]

36. Lee WC, Chan KM, Chou HS, Wu TJ, Lee CF, Soong RS, Wu TH, Lee CS. Feasibility of split liver transplantation for 2 adults in the model of end-stage liver disease era. Ann Surg. 2013;258:306–311.[PubMed]

37. Aseni P, De Feo TM, De Carlis L, Valente U, Colledan M, Cillo U, Rossi G, Mazzaferro V, Donataccio M, De Fazio N, et al. A prospective policy development to increase split-liver transplantation for 2 adult recipients: results of a 12-year multicenter collaborative study. Ann Surg. 2014;259:157–165.[PubMed]

38. Hashikura Y, Makuuchi M, Kawasaki S, Matsunami H, Ikegami T, Nakazawa Y, Kiyosawa K, Ichida T. Successful living-related partial liver transplantation to an adult patient. Lancet. 1994;343:1233–1234.[PubMed]

39. Lo CM, Fan ST, Liu CL, Lo RJ, Lau GK, Wei WI, Li JH, Ng IO, Wong J. Extending the limit on the size of adult recipient in living donor liver transplantation using extended right lobe graft. Transplantation. 1997;63:1524–1528.[PubMed]

40. Lee SG, Hwang S, Park KM, Kim KH, Ahn CS, Lee YJ, Cheon JY, Joo SH, Moon DB, Joo CW, et al. Seventeen adult-to-adult living donor liver transplantations using dual grafts. Transplant Proc. 2001;33:3461–3463.[PubMed]

41. Umeshita K, Fujiwara K, Kiyosawa K, Makuuchi M, Satomi S, Sugimachi K, Tanaka K, Monden M. Operative morbidity of living liver donors in Japan. Lancet. 2003;362:687–690.[PubMed]

42. Kwon KH, Kim YW, Kim SI, Kim KS, Lee WJ, Choi JS. Postoperative liver regeneration and complication in live liver donor after partial hepatectomy for living donor liver transplantation. Yonsei Med J. 2003;44:1069–1077.[PubMed]

43. Chan SC, Fan ST, Lo CM, Liu CL, Wong J. Toward current standards of donor right hepatectomy for adult-to-adult live donor liver transplantation through the experience of 200 cases. Ann Surg. 2007;245:110–117.[PMC free article][PubMed]

44. Muzaale AD, Dagher NN, Montgomery RA, Taranto SE, McBride MA, Segev DL. Estimates of early death, acute liver failure, and long-term mortality among live liver donors. Gastroenterology. 2012;142:273–280.[PubMed]

45. Sotiropoulos GC, Radtke A, Molmenti EP, Schroeder T, Baba HA, Frilling A, Broelsch CE, Malagó M. Long-term follow-up after right hepatectomy for adult living donation and attitudes toward the procedure. Ann Surg. 2011;254:694–700; discussion 700-701.[PubMed]

46. Kasahara M, Umeshita K, Inomata Y, Uemoto S. Long-term outcomes of pediatric living donor liver transplantation in Japan: an analysis of more than 2200 cases listed in the registry of the Japanese Liver Transplantation Society. Am J Transplant. 2013;13:1830–1839.[PubMed]

47. Hwang S, Lee SG, Lee YJ, Sung KB, Park KM, Kim KH, Ahn CS, Moon DB, Hwang GS, Kim KM, et al. Lessons learned from 1,000 living donor liver transplantations in a single center: how to make living donations safe. Liver Transpl. 2006;12:920–927.[PubMed]

48. Dahm F, Georgiev P, Clavien PA. Small-for-size syndrome after partial liver transplantation: definition, mechanisms of disease and clinical implications. Am J Transplant. 2005;5:2605–2610.[PubMed]

49. Serenari M, Cescon M, Cucchetti A, Pinna AD. Liver function impairment in liver transplantation and after extended hepatectomy. World J Gastroenterol. 2013;19:7922–7929.[PMC free article][PubMed]

50. Chen CL, Concejero AM, Lin TS, Lin YH, Chiang YC, Wang CC, Wang SH, Lin CC, Liu YW, Yong CC. Outcome of routine use of microsurgical biliary reconstruction in pediatric living donor liver transplantation. J Hepatobiliary Pancreat Sci. 2013;20:492–497.[PubMed]

51. Ishiko T, Egawa H, Kasahara M, Nakamura T, Oike F, Kaihara S, Kiuchi T, Uemoto S, Inomata Y, Tanaka K. Duct-to-duct biliary reconstruction in living donor liver transplantation utilizing right lobe graft. Ann Surg. 2002;236:235–240.[PMC free article][PubMed]

52. Liu CL, Lo CM, Chan SC, Fan ST. Safety of duct-to-duct biliary reconstruction in right-lobe live-donor liver transplantation without biliary drainage. Transplantation. 2004;77:726–732.[PubMed]

53. Fan ST, Lo CM, Liu CL, Tso WK, Wong J. Biliary reconstruction and complications of right lobe live donor liver transplantation. Ann Surg. 2002;236:676–683.[PMC free article][PubMed]

54. Kasahara M, Egawa H, Takada Y, Oike F, Sakamoto S, Kiuchi T, Yazumi S, Shibata T, Tanaka K. Biliary reconstruction in right lobe living-donor liver transplantation: Comparison of different techniques in 321 recipients. Ann Surg. 2006;243:559–566.[PMC free article][PubMed]

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56. Icoz G, Kilic M, Zeytunlu M, Celebi A, Ersoz G, Killi R, Memis A, Karasu Z, Yuzer Y, Tokat Y. Biliary reconstructions and complications encountered in 50 consecutive right-lobe living donor liver transplantations. Liver Transpl. 2003;9:575–580.[PubMed]

57.

Introduction

Substantial advances in clinical transplantation have occurred due to quantitative research. Randomized controlled trials of immunosuppression regimens [1] and registry studies utilizing the Scientific Registry of Transplant Recipients (SRTR) [2] or the Australian and New Zealand dialysis and transplant registry (ANZDATA) [3] provide high-quality evidence about potentially effective interventions or robust estimates of prognosis.

With the recent focus on patient-centeredness in research and decision-making, demonstrated by the launch of the patient-centered outcomes research institute (PCORI) by the US Patient Protection and Affordable Care Act of 2010 [4], it is timely to review qualitative research in the context of transplantation. While quantitative research addresses questions about the effectiveness of interventions or associations between risk factors and health outcomes, qualitative research plays a complementary role in generating understanding about people's behaviors, attitudes, values and experiences [5, 6].

Qualitative methods are especially suited to examining social phenomena when little is known about them. Additionally, qualitative methods offer critical insights into the experience and perspectives of patients and providers, and can be used for theory generation. For example, questions regarding patient preferences and beliefs about extended criteria donor organs or treatment decision-making is appropriately addressed by qualitative research. This knowledge is useful for example to facilitate patients' informed decision making about whether to accept extended criteria donor organs. However, qualitative research methods have limitations. While qualitative approaches can provide meaningful answers to questions such as “how,” they are less useful in answering questions of “how many” and relationships between factors. Qualitative research does not aim to test a hypothesis; rather it is hypothesis generating. To test hypotheses, further research is generally needed to support recommendations for incorporation or implementation into practice and policy.

Patient outcomes can be driven by biology and healthcare resources. Yet, statistical models of the associations between biology and health outcomes often indicate substantial and unexplained variability, which suggests that other factors may play an important role—including social or behavioral determinants. Given that decisions and behaviors are shaped by people's preferences and values, social phenomena can contribute to health outcomes. For example, late acute rejection and graft loss is often attributed to nonadherence, which is determined by the priorities of transplant recipients and their attitudes towards medicine taking.

Health services research, decision-making, communication, QOL and ethical analyses are major domains of research in transplantation that heavily rely on qualitative work to examine social, moral and structural factors rather than biological factors. For example, given the scarcity of organs, understanding how transplant providers decide whether to wait list patients is important to determine whether decisions are ethically sound and to determine possible sources of health disparities.

Also, qualitative research can be useful to identify reasons for healthcare resource shortages, and therefore inform ways to address resource scarcities or to reduce its impact. For example, the shortage of suitable deceased donor organs for transplantation can be explained, to some degree, by the attitudes and beliefs that underpin people's decisions regarding deceased donation. Qualitative research conducted with the community, families and intensive care physicians can be used to elicit the range of personal beliefs and behaviors that influence decisions about deceased donor transplantation and inform interventions and policy to improve deceased donation rates.

The vast international differences in transplant systems, health policy, public perspectives and social norms are an important consideration in the transferability of the theoretical knowledge and concepts generated in qualitative research. Qualitative research findings can be useful for informing further research and comparisons with other individuals or research populations. Moreover, the findings generated in comparative qualitative studies can help to explain the differences across various contexts. Of note, syntheses of multiple primary qualitative studies are emerging in the health literature to provide a more comprehensive conceptual understanding about a social phenomenon across healthcare contexts [7].

Qualitative research methods have been increasingly used to assess systematically social phenomena in solid organ transplantation, and editors of transplantation journals are receiving an increasing number of qualitative research submissions (personal communication with A. Kirk). Qualitative methods may yield answers to important elusive questions in transplantation including ethical dimensions and difficult life and death choices among transplant patients and providers, or be used to elicit the diversity of public opinions on ethical quandaries in transplantation such as solicitation of live donors or donor reimbursement. This review aims to highlight the recent contributions of qualitative research to transplantation practice and policy, present an array of qualitative methods used in transplantation research, and outline key principles to guide the appraisal of qualitative research.

Recent qualitative contributions to transplant clinical care and policy

Qualitative research methods may be used as a standalone project, or in mixed-methods studies to complement quantitative investigations by informing study design or to explain quantitative findings [8]. Mixed-method designs combine quantitative and qualitative methods. Pairing quantitative and qualitative approaches offers a number of advantages over utilizing one method alone, such as corroborating findings, generating more complete data, and using results from one method to enhance or explain insights attained with the complementary method. Mixed methods can be used when one data source is insufficient, to explain preliminary results, to generalize exploratory findings, or to achieve research perspectives which require multiple phases [9]. For example, qualitative findings may be used to design a survey or to explain survey results, or they may be used to inform the development and evaluation of an intervention. Or, in the context of a clinical trial, qualitative research can be used prior to trial design—for example, to explain nonadherence in transplant recipients and inform the design of an intervention that would be acceptable to patients as well as address adherence barriers; during a trial—to identify reasons for non-participation and impact of adverse events; and after a trial—to explain poor uptake or efficacy in the wider patient population.

Qualitative research on transplantation issues has been conducted for several decades. The work by Fox and Swazey conducted in the 1970s was pivotal and continues to inform organ donation policy [10]. The gift-giving bind and tyranny of the gift that Fox and Swazey documented contributed considerations in generation of the UNOS policy of maintaining anonymity between deceased donor families and recipients to avoid any “bind” after transplantation. Qualitative research has, however, garnered greater attention in more recent years. Qualitative research has provided insights into why socioeconomic inequities in access and barriers to organ donation and transplantation exist, why patients are nonadherent to immunosuppressive regimens, how patients experience and cope with the complex psychosocial outcomes of transplantation, and patient attitudes toward increased risk, or extended criteria, donor kidneys [11-16]. Recent examples of transplant research questions addressed by qualitative research methods are provided in Table 1.

Anthony et al. [40]Transitional care needs and experiences of pediatric heart transplant recipientsPhenomenologySemi-structured interviewsAdolescents expressed apathy and disinterest about transition; but perceived that adult care would be less communicative, serious and insensitive to their emotional needs.Transitional care should involve good communication and strategies to allay anxieties about adult-care environments.
Aujoulat et al. [41]Healthcare provider perspectives on nonadherence in adolescent transplant recipientsNot statedIn-depth interviewsHealthcare providers were uncertain about the operational definition of adherence, cause of organ rejection, the extent to which adherence was a shared responsibility, and long-term impact of a living related donation.Multidisciplinary healthcare teams need to acknowledge and address areas of uncertainty regarding patient education and treatment adherence.
D'Alessandro et al. [42]Social, cognitive and attitudinal dimensions on college students' support for organ donationNot statedSemi-structured interviews, focus groupsBenefits of organ donation and altruism impact on support for organ donationSocial media campaigns targeted at student populations may be effective for increasing rates of organ donor registration.
Social based communication is important for both support for organ donation and donor registration.
Gordon et al. [15]Kidney transplant candidates' understanding of increased risk donor kidneysEthnographySemi-structured interviewsMost patients would decline an increased risk donor kidney if offered due to concerns about risk or infectious disease transmission or poor quality.Informed consent should incorporate an assessment of patient comprehension and information about the risk of disease transition and quality of the kidney. Patients should be able to contextualize the current offer against future offers.
Patients wanted extensive information to make informed decisions about accepted increased risk of donor kidneys. 
Irving et al. [14]Community attitudes to deceased organ donation: a focus group studyGrounded theoryFocus groups, thematic analysisParticipants held core beliefs that both encouraged donation, such as “giving is good” and “saving lives,” and discouraged donation, such as loss of body dignity.Interventions should target improving confidence in the donation process (organ retrieval and consent) (e.g. via media).
They perceived donors may receive “suboptimal” medical care.Clarification of religious or cultural stance on organ donation may be warranted.
A simpler consent system where family could not veto a donor's decision was suggested.
Kranenburg et al. [43]Patient communication with potential living kidney donorsNot statedSemi-structured interviews, thematic analysisPatients understand the benefits of kidney transplantation but were hesitant to ask potential donors directly fearing rejection, disappointment or relationship tension.Transplant centers could provide counseling that addresses the knowledge, fears and concerns of patients. Patient advocates may be considered.
Howell et al. [27]Important outcomes for kidney transplant recipientsNot statedMixed methods: nominal group technique and focus group, thematic analysisUnderpinning priorities for outcomes were concern for fatal and serious events; relevance to life circumstance; acceptance, trivialization and tolerance; and future outlook. Participants described a willingness to tolerate side effects, dependent on personal relevance and ability to manage the side effects.Decision aids to guide immunosuppression treatment decision-making should incorporate patient priorities.
Papachristou et al. [44]Impact of living donor liver transplantation on the donor-recipient relationshipGrounded theorySemi-structured interviewsLiving liver donation enhances the existing positive or conflicting character of the relationship. Potential misuse or instrumentalization of the donation by the donor was possible and donation could not be used to improve the relationship.A thorough predonation evaluation of the donor-recipient relationship is needed to clarify potential conflicts and unrealistic expectations.
Ros et al. [16]Patient attitudes toward CDC high infectious risk donor kidney transplantationsGrounded theoryFocus groups, content analysis and thematic analysisPatients were unfamiliar and unprepared about infectious risk donor transplantation and perceive it to be the last option. However, education increased their interest and they wanted to be involved in decision-making. The opinion of the community nephrologist was valued.The UNOS mandate of special informed consent for infectious risk donor kidneys was validated. Information should include probability of infection. Shared decision-making may be facilitated by the community nephrologist.

The following examples demonstrate how qualitative research has the potential to inform clinical care and policy and ultimately lead to improved transplant outcomes.

Barriers to pursuing living kidney donation

Waterman and colleagues conducted a focus group study on patient-family communication about living kidney donation and identified several barriers to pursuing living donation. Kidney recipients were concerned about feeling guilty and indebted to the donor; wanted to avoid harm, inconvenience and potential disappointment to the donor; and were unaware about the possible psychological benefits to donors. Donors and recipients believed that education and training were needed to enable them to initiate requests for living donation with potential donors [17]. The findings have informed the design and evaluation of educational interventions that address patient refusal of living kidney donor offers by their family. For example, the study findings contributed to the development of a home-based educational intervention that provides patients and their support system with information regarding living kidney donation. A randomized controlled trial found the intervention to be effective in increasing living kidney donor transplantation rates [18].

Improving psychosocial outcomes in heart transplantation

Dew et al. [19] developed and evaluated an Internet-based intervention to improve psychosocial outcomes in heart transplantation. The intervention was directly informed by results of focus groups with heart recipients and caregivers. During the focus groups, participants discussed their needs and problems posttransplant, factors affecting their adjustment after transplant, interactions with the transplant team and their willingness to use the intervention. The website intervention was comprised of skills workshops, discussion groups, expert advice, questions and answer modules, healthy living tips and a resources library. The intervention group found a reduction in patient depressive and anxiety symptoms, caregivers' anxiety and hostility symptoms, and patient improvements in social functioning. Moreover, frequent users of the website reported improved mental health and quality of life benefits.

Variability in access to transplant follow-up

In a quantitative survey study conducted in the Upper Midwest of the United States, Israni et al. [20] 2009 found that patients of ethnic minority, lower median household income, and living within 10 miles from the transplant center were less likely to be seen by a nephrologist. Patients who infrequently attend nephrology visits after transplant may be at an increased risk of transplant failure. To better understand kidney transplant recipients' perceptions and beliefs regarding follow-up outpatient visits, semi-structured interviews and focus groups were conducted with recipients less likely to see a nephrologist [21]. Peer-support relationships and talking to other patients were found to motivate patients to attend their regular nephrology visits. However, perceived barriers to adherence to scheduled posttransplant visits included a strong desire for self-reliance following extended periods of dependence on others as dialysis patients; apprehension about being exposed to other ill patients, and anxiety about potentially receiving news of rejection or infection [21]. The lessons learnt from this qualitative study can be tested in future interventions trials, which could be incorporated into a transplant center's process of care. The findings emphasize the importance of educating patients about the need for routine follow-up visits and ongoing monitoring of kidney function, since early rejection can be asymptomatic; and suggests that nephrologist-patient communication should address the values and beliefs identified in the study in order to minimize posttransplant complications. An over emphasis on self-reliance could lead patients to seek medical care too late in the course of a complication post-transplant.

Misconceptions about increased risk donor kidneys

A recent study by Gordon et al. [15] 2012, found that patients held a number of misconceptions about increased risk donor kidneys. For example, many erroneously equated increased risk donor kidneys with marginal donor kidneys, believing that increased risk donor kidneys came from older donors and that the quality was poor. These findings are being used to inform an NIH-funded study involving the development of an Internet-based tool to educate transplant candidates about increased risk donor kidneys in order to optimize their informed consent about them. Specifically, this educational tool directly addresses the misconception in order to ensure that patients understand what these organs are and their associated risks so that they can make a more informed decision.

Pediatric to adult transition in solid organ transplantation

Quantitative studies have consistently demonstrated a greater incidence of nonadherence and poor outcomes in transplant recipients transferring from a pediatric center to an adult transplant unit [22]. Qualitative studies have identified a range of concerns from the perspectives of both adolescents and clinicians. Reiss et al. [23] found that young adults and their family members felt ill prepared to successfully participate in the adult health care system and that appropriate termination of pediatric relationships as part of the transition process was needed. The findings informed consensus guidelines for transitioning transplant recipients [24], and efforts by transplant centers to improve the transition process for patients [25, 26].

Qualitative methods used in transplantation research

Qualitative research encompasses a variety of different methodologies and methods. Methodologies offer a rationale or framework for the set of methods chosen. Commonly used methodologies in qualitative health research include grounded theory, phenomenology and ethnography (Table 2), which inform key aspects of study methods including participant selection and approaches to data collection and analysis (Table 3).

Grounded theory [34]Systematic and iterative data collection and constant comparative analysis to develop conceptual frameworks or theories about social processesInductive process of developing theory from the data.
Coding key concepts
Group concepts and identify themes
Identify relationships between concepts and themes
Resulting theory is conceptually dense and grounded in the data
Phenomenology[45]Philosophy based on reflective inquiry and description of the “lived experience” in a given context.Identify and describe participants' perception (understanding and interpretations) of daily life without reference to theories or scientific assumptions
Emphasized as explanations for actions.
Ethnography [46]Process of describing and interpreting the behaviors and actions of social groups or cultures usually through interviews and observations.Typically focused on a defined population
Close and detailed fieldwork involving multiple methods of data collection to generate descriptive data
Aims to develop theories from field study
Participant selection
PurposivePurposive sampling is most commonly used and involves the selection of participants that will yield information relevant to the research question. For example, participants representing a range of demographic or clinical characteristics may be identified to capture a diversity of views on a given topic. It does not aim to provide a statistically representative sample.
ConvenienceParticipants are selected because they are easily accessible and/or are willing to participate in the study. This may be less optimal as it may not capture perspectives from hard-to-reach populations who could provide additional rich, relevant and diverse data.
SnowballParticipants are identified by respondents involved in the study. This is usually used to identify participants in hard-to-reach populations.
Data collection
Interviews (in-depth and semi-structured)An interviewer engages the participant in in-depth discussion to gain their individual perspectives (emotions, experiences, attitudes, beliefs) about the research topic. Most questions are open-ended to allow participants to express themselves on their own terms.
Focus groupsA facilitated discussion with a group of people (usually 8–10 participants) engaged actively in conversation to express views on the research topic or question. It capitalizes on group interaction and dynamics. Focus groups are not a group interview nor are they used to achieve consensus.
ObservationsTo record observations of events and actions within a particular social or historical context. This may be done directly (observed by researchers) or indirectly (e.g. via videorecording). It may be passive (watching behaviors in natural settings) or active (the researcher has a role in the setting).
DocumentsDocument research involves identification, organization, evaluation and synthesis of documentary data. Examples of documents include news media, health service, policy and program documents, journal entries, internet or social media websites and visual images.
Data analysis
Thematic analysisThis is the most common form of qualitative analysis. A theme is a major thread, idea or pattern that recurs throughout the data. Concepts, themes and relationships between themes are inductively identified through careful from detailed reading and examination of the data collected.
Content analysisContent analysis is when researchers code data into codes that are identified and defined apriori. This deductive method is not generally used in studies where interviews or focus groups are used but may be appropriate when a meaningful denominator exists for reporting proportions. For example, a media analysis of stories about organ donation to investigate how organ donation is represented in the media where the number of media stories is known.

Participant selection

Generally, it is not feasible to sample the whole population of interest, and so a selection strategy is needed. For quantitative research, probability (random) sampling is generally used to achieve representativeness. A common critique of qualitative studies, which typically have smaller sample sizes, is that the findings are not generalizable. However, in qualitative research, participants who are able to provide rich and diverse information relevant to the research question are selected, and this can help to improve the transferability of concepts identified, not statistical generalizability [5].

Usually, purposive sampling involves the selection of information-rich cases to allow in-depth analysis relevant to the central issue being investigated [5]. Also, participant selection may be determined by concurrent data analysis where recruitment ceases when reaching saturation—the point in which no new themes are arising in subsequent data collection [27]. This strategy can ensure that the researcher has collected “sufficient” supporting data for their themes, and may be useful for ensuring that the diversity of views has been obtained. The sample size is largely determined by the methodological approach, scope of the study, study design and nature of the topic [28]. For example, in grounded theory, a minimum of 20–30 participants for each population of interest is generally reported to be adequate for achieving saturation but can vary between study populations [28]. For focus groups, typically 6–12 participants sharing a similar characteristic or experience are recruited for each group, with 3–5 groups convened for each variable of investigation [29]. In this framework, results should be representative of the broad range of views of the target population, but the distribution of views will not be representative and no inference should be made.

Data collection methods

Most qualitative health researchers use in-depth or semi-structured interviews or focus groups, which are particularly useful for gaining insight in people's experiences, values, and attitudes to inform healthcare practice and policy [30-32]. Data collection approaches should be comprehensive to enable rich descriptions of the phenomena investigated. Interview questions and prompts (also called “probes”) are designed to encourage open discussion. A hallmark of qualitative research is its flexibility; accordingly, the questions may be revised throughout the data collection process to address newly emergent topics, and to ensure that participants can express themselves freely and further clarify their opinions. To assess any similarity or differences in opinion, researchers may explore new issues raised by previous participants with new respondents. Typically, interviews or focus groups are audio-recorded and transcribed verbatim. Field notes are also taken to capture contextual details and non-verbal communication to inform data analysis.

Data analysis

Qualitative data analysis is an iterative, interpretive process, which involves reflective thought throughout a structured and comprehensive process of data reduction (i.e. to code and identify and label meaningful sections of data), data organisation (to collect, sort, and compile codes, develop categories, and recognize patterns and relationships in the data), and interpretation of written texts (to compare codes and categories, to contrast patterns and themes, and theories based on the data) [32]. These steps cycle over again until the representation of the phenomenon is complete and theoretically sound. Analysis may be informed by content knowledge and existing theory or empirical findings. Qualitative data analysis computer software can aid in storing, coding and retrieving data, but it cannot “code” or “interpret” the data for the investigator.

In qualitative research, the researcher him/herself serves as a research tool who interprets the data and is therefore inevitably “part of” the research. One of the challenges of qualitative research is that the research output can be read as the conviction or belief of the researcher. Good qualitative research uses several strategies to enhance the validity of study findings [5]. These include member checking, to ascertain whether the respondents' views were adequately interpreted; self-reflexivity, to check for potential biases on the part of the investigator that may have influenced decisions made during the study [26]; and triangulation, in terms of using multiple sources and types of data for eliciting more robust descriptions pertinent to the research topic or involving multiple researchers from different disciplines in the analysis to minimize excessive bias from an individual researcher influencing the findings.

Appraising qualitative research

Several checklists are available for appraising the quality of conducting and reporting of quantitative research, such as CONSORT for the reporting of RCTs. However, no universally accepted checklist is available for evaluating qualitative health research. The issue of quality in qualitative research is controversial; nevertheless, comprehensive guides for understanding, conducting and appraising qualitative research are available [5, 6, 27, 33-37]. For example, we recommend the use of the Consolidated Criteria for Reporting Qualitative Research (COREQ) [35], which was developed to promote explicit and comprehensive reporting of qualitative studies to inform appraisal. The following pragmatic principles can guide the appraisal of qualitative research, rather than serve as rigid definitive criteria. A guide and description are provided in Table 4.

1. CredibilityCan the findings be trusted?
Appropriate question guideQuestions guides and prompts are relevant to the research topic and phrased to encourage open and in-depth discussion.
Data triangulationMultiple sources of information and methods of data collection are used (e.g. combination of interviews, focus groups, observations; inclusion of different participant groups).
Investigator triangulationMultiple investigators are involved in the research process (e.g. from different disciplines).
Purposive samplingInformation-rich participants who can provide in-depth insight into the research questions are selected.
Theoretical saturationRecruitment of participants ceases when little or no new concepts are arising from subsequent discussions
Thick descriptionThe context of study and findings described in detail.
Researcher reflexivityResearchers identity and address potential biases that may have unduly influenced decisions made during the study.
2. DependabilityIs the process logical and auditable?
Recording of dataAudiotaping (or video recording) is used to capture all data collected. Field notes are taken to capture contextual details and nonverbal communication.
Verbatim transcriptionVerbal data are transcribed verbatim.
Computer softwareComputer software is used to assist with storage, coding and retrieval of data.
3. TransferabilityAre the findings relevant to other settings?
Comparison with other studiesFindings are situated in the context of other research conducted in different healthcare contexts.
Theoretical contextFindings are positioned within current theoretical or conceptual frameworks.
Detailed description of research contextStudy setting and participant characteristics are described in detail.
4. ConfirmabilityAre the findings and interpretations linked to the data?
Investigator checkingMultiple investigators reviewed the data and analysis to ensure the coding and analytical framework captures all primary data.
Member checkingParticipants provided feedback on the preliminary findings, which was incorporated into the analysis (e.g. a summary findings are sent to participants).
QuotationsSelected quotations (or other raw data) that illustrate the themes or findings are provided.

Credibility: Can the findings be trusted?

In quantitative research, validity refers to whether the research truly measures what it intended to measure or to what extent the study reflects “objective reality.” The qualitative methodologies described in Table 2 generally embrace the philosophical perspective that reality is socially and/or culturally constructed. Therefore, qualitative researchers appreciate that there is no single reality that is waiting to be observed, but rather, multiple realities exist that can be ascertained by eliciting many respondents' points of view. As qualitative research offers empirically based findings about social phenomena and is inevitably subjective, the term “credibility” is generally preferred [38, 39]. Credibility refers to the extent that the research offers well founded, reliable and sensible explanations based on the evidence obtained [31, 36].

Qualitative researchers can employ several strategies to enhance the credibility of their findings. For example, triangulation can be applied to various stages of the qualitative research process to generate more rich and comprehensive insight [32, 37]. This may be achieved by including multiple sources of information and methods of data collection, or involving investigators from various disciplines in the analysis. Another strategy, thick description of the data, allows the reader to assess how the findings may influence participant behavior and responses. Readers may wish to know whether the research was conducted in a clinical setting or by a clinician as it could explain why participants may feel apprehensive about establishing rapport and disclosing their perspectives. Also, readers may wish to review the interview guide and prompts used to assess whether the participants were encouraged to communicate their experiences and views in-depth on the research topic.

Dependability: Is the process logical and auditable?

Given that interpretative processes are intrinsic to qualitative research, it is not feasible for another researcher to produce identical findings; but they should be able to follow the research procedure [5]. Dependability addresses whether there is a coherent link between the findings, data, methods and methodology. Clarity about how data were collected and analyzed is needed to demonstrate that the study was conducted using rigorous and systematic approaches. Audiotaping and verbatim transcription are recommended [5]. Written notes cannot capture all the data and nuances expressed by the participant, and may limit the researcher's ability to develop rapport and ensure flow during data collection. Keeping an audit trail enhances the transparency of the research process. For example, the use of computer software for coding can increase the auditability of the research process as other researchers may view the coding structure and primary data to ascertain all concepts that were included in the data analysis.

Transferability: Are the findings relevant to other settings?

Generalizability of results and external validity are important in quantitative research. In qualitative research, however, the notion of transferability is considered, that is, whether the concepts and theories are relevant and have implications in other settings [31]. Study authors may discuss comparisons with other research conducted in different healthcare contexts or position their findings within current theoretical frameworks that might be relevant to various situations. By providing sufficient details about the study setting and participants, and a thorough description of the contextual details and findings, readers of a qualitative study will be better informed about judging whether the findings resonate in other contexts. For example, this can enable the reader to determine the applicability of the findings to their own setting.

Confirmability: Are the findings and interpretations linked to the data?

A commonly expressed misgiving about qualitative research is that the findings are simply a product of a researcher's imagination and “unduly” biased. However, findings of a qualitative study should be derived from the data collected and “accurately” reflect the perspectives, experiences and meanings as expressed by the participants [39]. This is to eliminate inappropriate bias where the interpretation and reporting of data simply reflects the researchers' values, beliefs or stance on the research topic. For example, this can achieved by involving multiple researchers in coding or independently reviewing the primary data to ensure the coding and analytical framework captures all of the data. A summary of the preliminary findings may be sent to participants for feedback, and corroboration then incorporated into the analysis (also called “member checking”) [37]. Participant quotations to illustrate the themes or findings must be provided, as the quotations constitute the data.

Conclusion

Qualitative research has a unique and complementary role in informing clinical practice and policy to improve health outcomes in transplantation, one that demands intersection of social science and transplant science. This review highlights some of the recent contributions of qualitative research to transplantation, and offers principles to guide its appraisal. Increased conduct and publication of rigorously assessed qualitative research will provide a broader base of evidence for clinicians and policy makers to advance and improve transplantation care and outcomes.

Acknowledgments

Authors contributions: AT, JRC, AI, EJG, JCC drafted the manuscript and reviewed the article critically for important intellectual content.

Funding source: AT is supported by the National Health and Medical Research Council Fellowship (ID1037162).

Author access to data: AT had full access to the data in the study and takes full responsibility for the integrity of the data and accuracy of the data analysis.

Disclosure

The authors of this manuscript have no conflicts of interest to disclose as described by the American Journal of Transplantation.

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