A randomized implementation trial to increase adoption of evidence-informed consent practices.

Introduction: Several evidence-informed consent practices (ECPs) have been shown to improve informed consent in clinical trials but are not routinely used. These include optimizing consent formatting, using plain language, using validated instruments to assess understanding, and involving legally authorized representatives when appropriate. We hypothesized that participants receiving an implementation science toolkit and a social media push would have increased adoption of ECPs and other outcomes. Methods: We conducted a 1-year trial with clinical research professionals in the USA (n = 1284) who have trials open to older adults or focus on Alzheimer's disease. We randomized participants to receive information on ECPs via receiving a toolkit with a social media push (intervention) or receiving an online learning module (active control). Participants completed a baseline survey and a follow-up survey after 1 year. A subset of participants was interviewed (n = 43). Results: Participants who engaged more with the toolkit were more likely to have tried to implement an ECP during the trial than participants less engaged with the toolkit or the active control group. However, there were no significant differences in the adoption of ECPs, intention to adopt, or positive attitudes. Participants reported the toolkit and social media push were satisfactory, and participating increased their awareness of ECPs. However, they reported lacking the time needed to engage with the toolkit more fully. Conclusions: Using an implementation science approach to increase the use of ECPs was only modestly successful. Data suggest that having institutional review boards recommend or require ECPs may be an effective way to increase their use.

What Can State Medical Boards Do to Effectively Address Serious Ethical Violations?

State Medical Boards (SMBs) can take severe disciplinary actions (e.g., license revocation or suspension) against physicians who commit egregious wrongdoing in order to protect the public. However, there is noteworthy variability in the extent to which SMBs impose severe disciplinary action. In this manuscript, we present and synthesize a subset of 11 recommendations based on findings from our team's larger consensus-building project that identified a list of 56 policies and legal provisions SMBs can use to better protect patients from egregious wrongdoing by physicians.

What Explains Associations of Researchers' Nation of Origin and Scores on a Measure of Professional Decision-Making? Exploring Key Variables and Interpretation of Scores.

Researchers encounter challenges that require making complex professional decisions. Strategies such as seeking help and anticipating consequences support decision-making in these situations. Existing evidence on a measure of professional decision-making in research (the PDR) that assesses the use of decision-making strategies revealed that NIH-funded researchers born outside of the U.S. tended to score below their U.S. counterparts. To examine potential explanations for this association, this study recruited 101 researchers born in the United States and 102 born internationally to complete the PDR and measures of basic personal values, values in scientific work, discrimination between the seriousness of rules in research, exposure to unprofessional research practices, and acculturation to American culture. Several variables were associated with PDR scores-discrimination between types of rules in research, exposure to unprofessional research practices, acculturation, and the basic personal values of power, security, and benevolence. However, only security, benevolence, acculturation, and rule discrimination were also associated with nation of origin. In multivariate models, the variance explained by these variables in accounting for the association of nation of origin and PDR scores was somewhat overlapping, thus, only security and benevolence remained as unique, statistically significant predictors. Thus, this study identified some important variables in the association of nation of origin and PDR, but more research is needed. In a secondary analysis to examine the "clinical significance" (the practical importance) of scores on the PDR, this study examined aggregated PDR score data from the present sample and past samples of investigators. This analysis identified scores that may suggest a concern versus those scores that may be interpreted as excellent, proficient, or marginal. Implications for training and mentoring, along with considerations for future research are discussed.

Development and Preliminary Validation of a New Measure of Values in Scientific Work.

In this paper we describe the development and initial psychometric evaluation of a new measure, the values in scientific work (VSW). This scale assesses the level of importance that investigators attach to different VSW. It taps a broad range of intrinsic, extrinsic, and social values that motivate the work of scientists, including values specific to scientific work (e.g., truth and integrity) and more classic work values (e.g., security and prestige) in the context of science. Notably, the values represented in this scale are relevant to scientists regardless of their career stage and research focus. We administered the VSW and a measure of global values to 203 NIH-funded investigators. Exploratory factor analyses suggest the delineation of eight VSW, including autonomy, research ethics, social impact, income, collaboration, innovation and growth, conserving relationships, and job security. These VSW showed predictable and distinct associations with global values. Implications of these findings for work on research integrity and scientific misconduct are discussed.

The Role of Culture and Acculturation in Researchers' Perceptions of Rules in Science.

Successfully navigating the norms of a society is a complex task that involves recognizing diverse kinds of rules as well as the relative weight attached to them. In the United States (U.S.), different kinds of rules-federal statutes and regulations, scientific norms, and professional ideals-guide the work of researchers. Penalties for violating these different kinds of rules and norms can range from the displeasure of peers to criminal sanctions. We proposed that it would be more difficult for researchers working in the U.S. who were born in other nations to distinguish the seriousness of violating rules across diverse domains. We administered a new measure, the evaluating rules in science task (ERST), to National Institutes of Health-funded investigators (101 born in the U.S. and 102 born outside of the U.S.). The ERST assessed perceptions of the seriousness of violating research regulations, norms, and ideals, and allowed us to calculate the degree to which researchers distinguished between the seriousness of each rule category. The ERST also assessed researchers' predictions of the seriousness that research integrity officers (RIOs) would assign to the rules. We compared researchers' predictions to the seriousness ratings of 112 RIOs working at U.S. research-intensive universities. U.S.-born researchers were significantly better at distinguishing between the seriousness of violating federal research regulations and violating ideals of science, and they were more accurate in their predictions of the views of RIOs. Acculturation to the U.S. moderated the effects of nationality on accuracy. We discuss the implications of these findings in terms of future research and education.

Making Professional Decisions in Research: Measurement and Key Predictors.

The professional decision-making in research (PDR) measure was administered to 400 National Institutes of Health (NIH)-funded and industry-funded investigators, along with measures of cynicism, moral disengagement, compliance disengagement, impulsivity, work stressors, knowledge of responsible conduct of research (RCR), and socially desirable response tendencies. Negative associations were found for the PDR and measures of cynicism, moral disengagement, and compliance disengagement, while positive associations were found for the PDR and RCR knowledge and positive urgency, an impulsivity subscale. PDR scores were not related to socially desirable responding, or to measures of work stressors and the remaining impulsivity subscales. In a multivariate logistic regression analysis, lower moral disengagement scores, higher RCR knowledge, and identifying the United States as one's nation of origin emerged as key predictors of stronger performance on the PDR. The implications of these findings for understanding the measurement of decision-making in research and future directions for research and RCR education are discussed.

Professional Decision-Making in Research (PDR): The Validity of a New Measure.

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.

Measuring kidney patients' motivation to pursue living donor kidney transplant: development of stage of change, decisional balance and self-efficacy measures.

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 (N 1 = 279 and N 2 = 204), results showed good psychometric properties and support for their use in the assessment of living donor kidney transplant interventions.

Your Path to Transplant: a randomized controlled trial of a tailored computer education intervention to increase living donor kidney transplant.

BACKGROUND: Because 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/DESIGN: Nine 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. DISCUSSION: At 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 REGISTRATION: ClinicalTrials.gov, number NCT02181114.