While educational interventions to increase patient motivation to pursue living donor kidney transplant have shown success in increasing living donor kidney transplant rates, there are no validated, theoretically consistent measures of Stage of Change, a measure of readiness to pursue living donor kidney transplant; Decisional Balance, a weighted assessment of living donor kidney transplant’s advantages/disadvantages; and Self-Efficacy, a measure of belief that patients can pursue living donor kidney transplant in difficult circumstances. This study developed and validated measures of these three constructs. In two independent samples of kidney patients (N1= 279 N2= 204), results showed good psychometric properties and support for their use in the assessment of living donor kidney transplant interventions.

We found no studies in the United States that explored research participants' perspectives about sharing their qualitative data. We present findings from interviews with 30 individuals who participated in sensitive qualitative studies to explore their understanding and concerns regarding qualitative data sharing. The vast majority supported sharing qualitative data so long as their data were deidentified and shared only among researchers. However, they raised concerns about confidentiality if the data were not adequately deidentified and about misuse by secondary users if data were shared beyond the research community. These concerns, though, did not deter them from participating in research. Notably, participants hoped their data would be shared and may have expected or assumed this was already happening. While many could not recollect details about data‐sharing plans for studies in which they participated, they trusted researchers and institutions to appropriately handle data sharing. If individuals view data sharing as an extension or integral part of their participation in qualitative research, then researchers may have a stronger obligation to share qualitative data than previously thought. Guidelines and tools to assist researchers and institutional review board members in ethical and responsible qualitative data sharing are urgently needed.

Data sharing maximizes the value of data, which is time and resource intensive to collect. Major funding bodies in the United States (US), like the National Institutes of Health (NIH), require data sharing and researchers frequently share de-identified quantitative data. In contrast, qualitative data are rarely shared in the US but the increasing trend towards data sharing and open science suggest this may be required in future. Qualitative methods are often used to explore sensitive health topics raising unique ethical challenges regarding protecting confidentiality while maintaining enough contextual detail for secondary analyses. Here, we report findings from semi-structured in-depth interviews with 30 data repository curators, 30 qualitative researchers, and 30 IRB staff members to explore their experience and knowledge of QDS. Our findings indicate that all stakeholder groups lack preparedness for QDS. Researchers are the least knowledgeable and are often unfamiliar with the concept of sharing qualitative data in a repository. Curators are highly supportive of QDS, but not all have experienced curating qualitative data sets and indicated they would like guidance and standards specific to QDS. IRB members lack familiarity with QDS although they support it as long as proper legal and regulatory procedures are followed. IRB members and data curators are not prepared to advise researchers on legal and regulatory matters, potentially leaving researchers who have the least knowledge with no guidance. Ethical and productive QDS will require overcoming barriers, creating standards, and changing long held practices among all stakeholder groups.

BackgroundBecause of the deceased donor organ shortage, more kidney patients are considering whether to receive kidneys from family and friends, a process called living donor kidney transplantation (LDKT). Although Blacks and Hispanics are 3.4 and 1.5 times more likely, respectively, to develop end stage renal disease (ESRD) than Whites, they are less likely to receive LDKTs. To address this disparity, a new randomized controlled trial (RCT) will assess whether Black, Hispanic, and White transplant patients’ knowledge, readiness to pursue LDKT, and receipt of LDKTs can be increased when they participate in the Your Path to Transplant (YPT) computer-tailored intervention.Methods/DesignNine hundred Black, Hispanic, and White ESRD patients presenting for transplant evaluation at University of California, Los Angeles Kidney and Pancreas Transplant Program (UCLA-KPTP) will be randomly assigned to one of two education conditions, YPT or Usual Care Control Education (UC). As they undergo transplant evaluation, patients in the YPT condition will receive individually-tailored telephonic coaching sessions, feedback reports, video and print transplant education resources, and assistance with reducing any known socioeconomic barriers to LDKT. Patients receiving UC will only receive transplant education provided by UCLA-KPTP. Changes in transplant knowledge, readiness, pros and cons, and self-efficacy to pursue LDKT will be assessed prior to presenting at the transplant center (baseline), during transplant evaluation, and 4- and 8-months post-baseline, while completion of transplant evaluation and receipt of LDKTs will be assessed at 18-months post-baseline. The RCT will determine, compared to UC, whether Black, Hispanic, and White patients receiving YPT increase in their readiness to pursue LDKT and transplant knowledge, and become more likely to complete transplant medical evaluation and pursue LDKT. It will also examine how known patient, family, and healthcare system barriers to LDKT act alone and in combination with YPT to affect patients’ transplant decision-making and behavior. Statistical analyses will be performed under an intent-to-treat approach.DiscussionAt the conclusion of the study, we will have assessed the effectiveness of an innovative and cost-effective YPT intervention that could be utilized to tailor LDKT discussion and education based on the needs of individual patients of different races in many healthcare settings.Trial registrationClinicalTrials.gov, number NCT02181114.

In this paper, we report on the development and validity of the Professional Decision-Making in Research (PDR) measure, a vignette-based test that examines decision-making strategies used by investigators when confronted with challenging situations in the context of empirical research. The PDR was administered online with a battery of validity measures to a group of NIH-funded researchers and research trainees who were diverse in terms of age, years of experience, types of research, and race. The PDR demonstrated adequate reliability (alpha = .84) and parallel form correlation (r = .70). As hypothesized, the PDR was significantly negatively correlated with narcissism, cynicism, moral disengagement, and compliance disengagement; it was not correlated with socially desirable responding. In regression analysis, the strongest predictors of higher PDR scores were low compliance disengagement, speaking English as a native language, conducting clinical research with human subjects, and low levels of narcissism. Given that the PDR was written at an eighth grade reading level to be suitable for use with English as a second language participants and that only one-fourth of items focused on clinical research, further research into the possible roles of culture and research ethics training across specialties is warranted. This initial validity study demonstrates the potential usefulness of the PDR as an educational outcome assessment measure and a research instrument for studies on professionalism and integrity in research.