Comparing a Multimedia Digital Informed Consent Tool With Traditional Paper-Based Methods: Randomized Controlled Trial.

BACKGROUND: The traditional informed consent (IC) process rarely emphasizes research participants' comprehension of medical information, leaving them vulnerable to unknown risks and consequences associated with procedures or studies. OBJECTIVE: This paper explores how we evaluated the feasibility of a digital health tool called Virtual Multimedia Interactive Informed Consent (VIC) for advancing the IC process and compared the results with traditional paper-based methods of IC. METHODS: Using digital health and web-based coaching, we developed the VIC tool that uses multimedia and other digital features to improve the current IC process. The tool was developed on the basis of the user-centered design process and Mayer's cognitive theory of multimedia learning. This study is a randomized controlled trial that compares the feasibility of VIC with standard paper consent to understand the impact of interactive digital consent. Participants were recruited from the Winchester Chest Clinic at Yale New Haven Hospital in New Haven, Connecticut, and healthy individuals were recruited from the community using fliers. In this coordinator-assisted trial, participants were randomized to complete the IC process using VIC on the iPad or with traditional paper consent. The study was conducted at the Winchester Chest Clinic, and the outcomes were self-assessed through coordinator-administered questionnaires. RESULTS: A total of 50 participants were recruited in the study (VIC, n=25; paper, n=25). The participants in both groups had high comprehension. VIC participants reported higher satisfaction, higher perceived ease of use, higher ability to complete the consent independently, and shorter perceived time to complete the consent process. CONCLUSIONS: The use of dynamic, interactive audiovisual elements in VIC may improve participants' satisfaction and facilitate the IC process. We believe that using VIC in an ongoing, real-world study rather than a hypothetical study improved the reliability of our findings, which demonstrates VIC's potential to improve research participants' comprehension and the overall process of IC. TRIAL REGISTRATION: ClinicalTrials.gov NCT02537886; https://clinicaltrials.gov/ct2/show/NCT02537886.

Kidney Biopsy-Related Complications in Hospitalized Patients with Acute Kidney Disease.

BACKGROUND AND OBJECTIVES: Patients are informed of the risk of kidney biopsy-related complications using data from nonhospitalized patients, which may underestimate the risk for hospitalized patients. We evaluated the rate and risk factors of kidney biopsy-related complications in hospitalized patients with acute kidney disease (AKD) to better estimate the risk in this population. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We used data from the Yale biopsy cohort to evaluate rates of kidney biopsy-related complications including adjudicated procedure-related bleeding requiring blood transfusions or angiographic interventions, medium- or large-sized hematomas, reimaging after biopsy including abdominal ultrasonography or computed tomography, and death in hospitalized patients with AKD (including AKI). We evaluated univariable and multivariable association of risk factors with transfusions. We compared rates of complications between hospitalized and nonhospitalized patients. RESULTS: Between 2015 and 2017, 159 hospitalized patients underwent a kidney biopsy for AKD evaluation, of which 80 (51%) had stage 1 AKI, 42 (27%) had stage 2 (or higher) AKI, and 27 (17%) had AKD (without AKI). Of these, 12 (8%; 95% confidence interval [95% CI], 5% to 15%) required a transfusion, three (2%; 95% CI, 1% to 5%) required an intervention, 11 (7%; 95% CI, 4% to 12%) had hematoma, and 31 (20%; 95% CI, 14% to 26%) required reimaging after biopsy. Of the four (3%; 95% CI, 1% to 6%) deaths during hospitalization, none were related to the biopsy. Female sex, lower platelet count, and higher BUN were associated with postbiopsy transfusions on univariable and multivariable analyses. Trainee as proceduralist and larger needle gauge were associated with transfusions in univariable, but not multivariable, analysis. Nonhospitalized patients had lower rates of transfusion than hospitalized patients, although the latter also had lower prebiopsy hemoglobin and greater surveillance after biopsy. CONCLUSIONS: Hospitalized patients experience higher risk of postbiopsy complications than previously reported and several factors, such as lower platelet count, female sex, and higher BUN, are associated with this risk.

A Survey of Patient Attitudes Toward Participation in Biopsy-Based Kidney Research.

INTRODUCTION: As part of the precision medicine initiative, the National Institutes of Health/National Institute of Diabetes and Digestive Kidney Diseases has proposed collecting human kidney tissue to discover novel therapeutic targets from patients with kidney diseases. Patient attitudes on participating in kidney biopsy-based research are largely unknown. METHODS: We evaluated attitudes toward donating kidney tissue to research among participants who had experienced a clinically indicated kidney biopsy, through a survey conducted 9 months (interquartile range, 5-13 months) after their biopsy. RESULTS: Of the 177 participants contacted, 117 (66%) participated in the survey. A total of 85 participants (73%) reported that they would allow additional needle passes during a clinically indicated biopsy to donate kidney tissue for research. As reasons for participating in such a study, the participants reported the desire to help others and to contribute to science, and the lack of additional burden while participating in such a study. In a multivariable logistic model, older and African American participants had lower odds of allowing an additional pass for research (odds ratio: age ≥65 years [vs. ≤40], 0.15 [95% confidence interval, 0.03-0.73]; African Americans (vs. all others), 0.15 [95% confidence interval, 0.05-0.44]). However, participants' self-reported biopsy complications such as pain, anxiety, and hematuria did not affect their willingness to allow additional passes. A total of 23 participants (20%) stated that they would agree to undergo a biopsy for research even if it was not clinically indicated. CONCLUSION: Among patients who had experienced a kidney biopsy, a majority were amenable to additional needle passes to donate kidney tissue for research during a future, clinically indicated biopsy, whereas a minority would undergo a biopsy for research purpose only.

Building an Informed Consent Tool Starting with the Patient: The Patient-Centered Virtual Multimedia Interactive Informed Consent (VIC).

Patient safety and quality of care are at risk if the informed consent process does not emphasize patient comprehension. In this paper, we describe how we designed, developed, and evaluated an mHealth tool for advancing the informed consent process. Our tool enables the informed consent process to be performed on tablets (e.g., iPads) utilizing virtual coaching with text-to-speech automated translation as well as an interactive multimedia elements (e.g., graphics, video clips, animations, presentations, etc.). We designed our tool to enhance patient comprehension and quality of care, while improving the efficiency of obtaining patient consent. We present the Used-Centered Design approach we adopted to develop the tool and the results of the different methods we used during the development of the tool. Also, we describe the results of the usability study which we conducted to evaluate the effectiveness, efficiency, and user satisfaction with our mHealth App to enhance the informed consent process. Using the UCD approach we were able to design, develop, and evaluate a highly interactive mHealth App to deliver the informed consent process.

Research participant-centered outcomes at NIH-supported clinical research centers.

BACKGROUND: Although research participation is essential for clinical investigation, few quantitative outcome measures exist to assess participants' experiences. To address this, we developed and deployed a survey at 15 NIH-supported clinical research centers to assess participant-centered outcomes; we report responses from 4,961 participants. METHODS: Survey questions addressed core aspects of the research participants' experience, including their overall rating, motivation, trust, and informed consent. We describe participant characteristics, responses to individual questions, and correlations among responses. RESULTS: Respondents broadly represented the research population in sex, race, and ethnicity. Seventy-three percent awarded top ratings to their overall research experience and 94% reported no pressure to enroll. Top ratings correlated with feeling treated with respect, listened to, and having access to the research team (R(2) = 0.80-0.96). White participants trusted researchers more (88%) than did nonwhite participants collectively (80%; p < 0.0001). Many participants felt fully prepared by the informed consent process (67%) and wanted to receive research results (72%). CONCLUSIONS: Our survey demonstrates that a majority of participants at NIH-supported clinical research centers rate their research experience very positively and that participant-centered outcome measures identify actionable items for improvement of participant's experiences, research protections, and the conduct of clinical investigation.

Conducting research with human subjects in international settings: ethical considerations.

Biomedical research in international settings is undergoing expansive growth and may potentially result in far-reaching benefits, such as direction of research resources toward solving basic health care needs of world populations. However, key ethical concerns surround this expansion and must be carefully considered by international researchers. International research is impacted by differences in language, culture, regulatory structures, financial resources, and possibly ethical standards. Local community leadership involvement in the planning stages of research is imperative. Especially in resource-poor countries, the research agenda must be designed to address local needs and provide local benefit. Capacity strengthening efforts, aimed at improving institutional support for ethical conduct of human subjects research, must continue to be supported by wealthier nations.