Specialty Care Referral for Underrepresented Minorities Living with HIV in the United States: Experiences, Barriers, and Facilitators.

The increased incidence of chronic diseases among people with HIV (PWH) is poised to increase the need for specialty care outside of HIV treatment settings. To reduce outcome disparities for HIV-associated comorbidities in the United States, it is critical to optimize access to and the quality of specialty care for underrepresented racial and ethnic minority (URM) individuals with HIV. We explored the experiences of URM individuals with HIV and other comorbidities in the specialty care setting during their initial and follow-up appointments. We conducted qualitative interviews with participants at three large academic medical centers in the United States with comprehensive health care delivery systems between November 2019 and March 2020. The data were analyzed using applied thematic analysis. A total of 27 URM individuals with HIV were interviewed. The majority were Black or African American and were referred to cardiology specialty care. Most of the participants had positive experiences in the specialty care setting. Facilitators of the referral process included their motivation to stay healthy, referral assistance from HIV providers, access to reliable transportation, and proximity to the specialty care health center. Few participants faced individual, interpersonal, and structural barriers, including the perception of individual and facility stigma toward PWH, a lack of transportation, and a lack of rapport with providers. Future case studies are needed for those URM individuals with HIV who face barriers and negative experiences. Interventions that involve PWH and health care providers in specialty care settings with a focus on individual- and structural-level stigma can support the optimal use of specialty care.

Assisting Black Patients With Decision-Making for Implantable Cardioverter Defibrillator Therapy: Qualitative Findings From the Videos to Reduce Racial Disparities in ICD Therapy via Innovative Designs (VIVID) Trial.

BACKGROUND: The VIVID (Videos for Addressing Racial Disparities in Implantable Cardioverter Defibrillator Therapy via Innovative Designs) study was a multicenter, randomized controlled trial aimed at evaluating the effectiveness of a video-based decision support tool in enhancing informed consent for implantable cardioverter defibrillator (ICD) implantation among Black patients who met guideline criteria for primary prevention ICDs. Within the broader VIVID randomized trial, a qualitative investigation was conducted to elucidate the decisional factors among Black individuals considering ICD implantation for the primary prevention of sudden cardiac arrest. METHODS: Between October 2016 and July 2019, in-depth interviews were conducted at 2 time points from randomization, ≈7 days (time interval for the decision) and at 90 days; the time interval for determining ICD implantation. Interview findings were categorized by randomized groups, those assigned to 1 of the 2 encounter-based video decision support tools or standard care (without video). Interview participants were purposefully selected to ensure diversity across gender, age, educational background, research site, and randomization group; participants were sampled from 14 academic and community-based electrophysiology clinics in the United States. Data analysis employed applied thematic analysis techniques. RESULTS: A diverse sample of Black individuals were interviewed at 1 week (n=59; female, 37.3%) and 90 days (n=48; female, 39.6%). The primary factors influencing the decisions of Black individuals considering a primary prevention ICD implantation were (1) their clinicians' recommendations for ICD implantation; (2) their perception of their cardiac health status; and (3) a desire to prolong their lives for the sake of their families. CONCLUSIONS: These findings offer valuable insights that may guide clinicians in their communication with Black patients during shared decision-making encounters related to ICD implantation.

A qualitative study of facilitators of medication adherence in systemic lupus erythematosus: Perspectives from rheumatology providers/staff and patients.

OBJECTIVE: Systemic lupus erythematosus (SLE) disproportionately affects patients from racial and ethnic minority groups. Medication adherence is lower among these patient populations, and nonadherence is associated with worse health outcomes. We aimed to identify factors that enable adherence to immunosuppressive medications among patients with SLE from racial and ethnic minority groups. METHODS: Using a qualitative descriptive study design, we conducted in-depth interviews with purposefully selected (1) patients with SLE from racial and ethnic minority groups who were taking immunosuppressants and (2) lupus providers and staff. We focused on adherence facilitators, asking patients to describe approaches supporting adherence and for overcoming common adherence challenges and providers and staff to describe actions they can take to foster patient adherence. We used applied thematic analysis and categorized themes using the Capability, Opportunity, Motivation, Behavior (COM-B) model. RESULTS: We interviewed 12 patients (4 adherent and 8 nonadherent based on medication possession ratio) and 12 providers and staff. Although each patient described a unique set of facilitators, patients most often described social support, physical well-being, reminders, and ability to acquire medications as facilitators. Providers also commonly mentioned reminders and easy medication access as facilitators as well as patient education/communication and empowerment. CONCLUSION: Using an established behavioral change model, we categorized a breadth of adherence facilitators within each domain of the COM-B model while highlighting patients' individual approaches. Our findings suggest that an optimal adherence intervention may require a multi-modal and individually tailored approach including components from each behavioral domain-ensuring medication access (Capability) and utilizing reminders and social support (Opportunity), while coupled with internal motivation through improved communication and empowerment (Motivation).

Patients' Experiences With the Removal of a Ureteral Stent: Insights From In-depth Interviews With Participants in the USDRN STENTS Qualitative Cohort Study.

OBJECTIVE: To describe the experiences of patients undergoing stent removal in the USDRN Study to Enhance Understanding of Stent-Associated Symptoms (STENTS), a prospective, observational cohort study of patients with short-term ureteral stent placement post-ureteroscopy. METHODS: We conducted a qualitative descriptive study using in-depth interviews. Participants reflected on (1) painful or bothersome aspects of stent removal, (2) symptoms immediately after removal, and (3) symptoms in the days following removal. Interviews were audio-recorded, transcribed, and analyzed using applied thematic analysis. RESULTS: The 38 participants interviewed were aged 13-77 years, 55% female, and 95% White. Interviews were conducted 7-30 days after stent removal. Almost all participants (n = 31) described that they experienced either pain or discomfort during stent removal, but for most (n = 25) pain was of short duration. Many participants (n = 21) described anticipatory anxiety related to the procedure, and several (n = 11) discussed discomfort arising from lack of privacy or feeling exposed. Interactions with medical providers often helped put participants at ease, but also increased discomfort for some. Following stent removal, several participants described lingering pain and/or urinary symptoms, but these largely resolved within 24 hours. A few participants described symptoms persisting for more than a day post stent removal. CONCLUSION: These findings on patients' experiences during and shortly after ureteral stent removal, particularly the psychological distress they experienced, identify opportunities for improvement in patient care. Clear communication from providers about what to expect with the removal procedure, and the possibility of delayed pain, may help patients adapt to discomfort.

The Patient Voice: Stent Experiences After Ureteroscopy-Insights from In-Depth Interviews with Participants in the USDRN STENTS Nested Qualitative Cohort Study.

Purpose: Ureteral stents are commonly used after ureteroscopy and cause significant discomfort, yet qualitative perspectives on patients' stent experiences remain unknown. We describe psychological, functional, and interpersonal effects of post-ureteroscopy stents and whether additional patient-reported assessments may be needed. Materials and Methods: Using a qualitative descriptive study design, we conducted in-depth interviews with a nested cohort of participants in the STudy to Enhance uNderstanding of sTent-associated Symptoms (STENTS). Participants shared their symptoms with a post-ureteroscopy stent and described symptom bother and impact on daily activities. All interviews were audio-recorded, transcribed, and analyzed using applied thematic analysis. During analysis, participants' experiences with interference in daily activities were categorized into three groups based on their impact: minimal, moderate, and substantial. Results: All 39 participants experienced pain, although descriptions varied and differentiated between feelings of pain vs discomfort. Almost all experienced urinary symptoms. Only a few reported other physical symptoms, although several psychological aspects were identified. In the areas of sleep, mood, life enjoyment, work, exercise, activities of daily living, driving, childcare, and leisure/social activities, the stent had little impact on daily living among participants placed in the minimal group (n = 12) and far greater impact for participants in the substantial group (n = 8). For patients in the moderate group (n = 19), some daily activities were moderately or substantially affected, whereas other activities were minimally affected. Conclusions: Counseling to better prepare patients for the impact of stent-associated symptoms may help mitigate symptom burden. While existing instruments adequately cover most symptoms, additional assessments for other domains, particularly psychological factors, may be needed.

Patient perspectives on considerations, tradeoffs, and experiences with multiple myeloma treatment selection: a qualitative descriptive study.

BACKGROUND: Advances in multiple myeloma treatment and a proliferation of treatment options have resulted in improved survival rates and periods of symptom-free remission for many multiple myeloma patients. As a result, health-related quality of life (HRQoL) concerns related to myeloma treatments have become increasingly salient for this patient population and represent an important consideration guiding patients' treatment choices. To gain an understanding of patients' experiences with choosing myeloma therapies and explore the HRQoL concerns that are most important to them, we interviewed a diverse sample of US-based multiple myeloma patients about their treatment considerations. METHODS: We conducted a qualitative descriptive study using in-depth interviews. Participants reflected on (1) the factors that were most important to them when thinking about multiple myeloma treatment and how these have changed over time, (2) how they might weigh the importance of treatment efficacy vs. side effects, (3) trade-offs they would be willing to make regarding efficacy vs. HRQoL, and (4) treatment changes they had experienced. Interviews were audio-recorded and transcribed, and narratives were analyzed using applied thematic analysis. RESULTS: We interviewed 21 patients, heterogeneous in their disease trajectory and treatment experience. Participants were 36 to 78 years, 52% female, and 38% Black. Efficacy was named as the most important treatment consideration by almost two-thirds of participants, and over half also valued HRQoL aspects such as the ability to maintain daily functioning and enjoyment of life. Participants expressed concern about potential treatment side effects and preferred more convenient treatment options. Although participants stated largely trusting their clinicians' treatment recommendations, many said they would stop a clinician-recommended treatment if it negatively impacted their HRQoL. Participants also said that while they prioritized treatment efficacy, they would be willing to change to a less efficacious treatment if side effects became intolerable. CONCLUSIONS: Our findings link to other reports reflecting considerations that are important to multiple myeloma patients, including the importance placed on increasing life expectancy and progression-free survival, but also the tension between treatment efficacy and quality of life. Our results extend these findings to a racially diverse US-based patient population at different stages in the disease trajectory.

Caregivers of Black and Latino/a/x Students and School Personnel Perspectives on School-Based SARS-CoV-2 Testing: Implications for Testing and Test-to-Stay Programs in K-12 Schools.

BACKGROUND: "Test-to-stay" (TTS) is an effective approach for keeping students in school post-exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). To prepare for school-based SARS-CoV-2 testing, we implemented formative research to gather perspectives on school-based testing among school personnel, as well as caregivers of Black and Latino/a/x students given systemic racism, existing school inequalities, and the disproportionate effect of COVID-19 on Black and Latino/a/x populations. METHODS: We conducted in-depth interviews with caregivers of K-12 grade Black and Latino/a/x students and focus group discussions with K-12 school personnel. We described the forthcoming school-based SARS-CoV-2 testing program and explored potential benefits and concerns, including concerns about testing-related stigma and discrimination, particularly toward Black and Latino/a/x students, and implementation recommendations. RESULTS: Perceived testing benefits included school community reassurance and preventing school outbreaks. Concerns included potential student anxiety, classroom disruption, inaccurate results, and limited information for caregivers. Some participants mentioned that testing-related stigma and discrimination could happen based on the testing selection process or results but not due to race or ethnicity. Participants provided numerous testing recommendations, including suggestions to prevent negative outcomes. CONCLUSIONS: Participants believed that stigma and discrimination from SARS-CoV-2 testing is possible, although differential treatment based on race or ethnicity was not anticipated. Participants' narratives provide support for school-based testing and the testing component of TTS.

Caregiving in U.S. Gulf States During Natural Disasters and COVID-19.

Objectives: To ascertain common experiences and needs of a diverse group of caregivers challenged by hurricanes/floods and COVID-19. Methods: In-depth interviews with unpaid caregivers in U.S. Southeast/Gulf Coast states who had experienced caregiving during a natural disaster and during COVID-19. Results: Caregivers report challenges including daily living disruption, altered social supports, complicated health management, additional disaster planning, and emotional/financial impacts. Caregivers suggested helpful resources, policy options, and preparatory tools at individual, local, and health system levels to mediate discontinuity. Conclusions: Our data describe combined caregiver experiences of hurricanes/floods and the pandemic. Caregivers experience unique burdens related to care recipient diagnosis, location, and veteran status. Access to community supports varies as they manage the tasks required for care recipients' health and safety. Our findings indicate the need for public health reinforcement of caregiving though caregiver pre-planning and targeted support. Bolstering understanding of communities' caregiving capacity though first responder trainings and caregiver registries may enhance health and safety.

Stakeholders' views on the most and least helpful aspects of the ICH E6 GCP guideline and their aspirations for the revision of ICH E6(R2).

Background: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has published the ICH E6(R2) Good Clinical Practice (GCP) guideline, which provides standards for the design, conduct, documentation, and reporting of clinical trials. Revision to E6(R2) is currently underway, aiming to adapt the guidance to the current regulatory environment. The Clinical Trials Transformation Initiative (CTTI) interviewed stakeholders, gathering their experiences implementing ICH E6 GCP and suggestions for revising the guidance. Methods: We conducted a qualitative descriptive study using in-depth interviews. Participants were purposefully selected to ensure diversity in geography, research role, and type of institution. Participants reflected on their aspirations for the ICH E6 GCP revision and described sections of the guidance that they found most and least helpful. Narratives were analyzed using applied thematic analysis. Results: Many participants found ICH E6 GCP generally clear and helpful. They appreciated that the guidance is globally accepted and serves as a common standard for research worldwide. Participants also noted opportunities for improvement, suggesting that the revised guidance should incorporate flexibility, simplify requirements, and accommodate advances in research conduct. They highlighted areas where language should be updated and concepts clarified and expressed a desire for transparency and inclusiveness in the revision process. Conclusion: Our findings show that many participants view the ICH E6(R2) guidance as helpful overall, although substantial room for improvement remains. We have provided the full report of these findings to ICH in hopes that it will be useful as the E6 GCP guideline is revised.

Perspectives of HIV specialists and cardiologists on the specialty referral process for people living with HIV: a qualitative descriptive study.

BACKGROUND: Cardiology care may be beneficial for risk factor management in people living with HIV (PLWH), yet limited information is available about the referral process from the perspectives of HIV specialists and cardiologists. METHODS: We conducted 28 qualitative interviews at academic medical centers in the United States from December 2019 to February 2020 using components of the Specialty Referral Process Framework: referral decision, entry into referral care, and care integration. We analyzed the data using applied thematic analysis. RESULTS: Reasons for cardiology referral most commonly included secondary prevention, uncontrolled risk factors, cardiac symptoms, and medication management. Facilitators in the referral process included ease of referral, personal relationships between HIV specialists and cardiologists, and close proximity of the clinic to the patient's home. Barriers included lack of transportation, transportation costs, insurance coverage gaps, stigma, and patient reluctance. CONCLUSIONS: Our results will inform future studies on implementation strategies aimed at improving the specialty referral process for PLWH. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04025125 .

Barriers to Taking Medications for Systemic Lupus Erythematosus: A Qualitative Study of Racial Minority Patients, Lupus Providers, and Clinic Staff.

OBJECTIVE: Underrepresented racial and ethnic minorities are disproportionately affected by systemic lupus erythematosus (SLE). Racial and ethnic minorities also have more severe SLE manifestations that require use of immunosuppressive medications, and often have lower rates of medication adherence. We aimed to explore barriers of adherence to SLE immunosuppressive medications among minority SLE patients. METHODS: We conducted a qualitative descriptive study using in-depth interviews with a purposive sample of racial minority SLE patients taking oral immunosuppressants (methotrexate, azathioprine, or mycophenolate), and lupus clinic providers and staff. Interviews were audiorecorded, transcribed, and analyzed using applied thematic analysis. We grouped themes using the Capability, Opportunity, Motivation, Behavior conceptual model. RESULTS: We interviewed 12 SLE patients (4 adherent, 8 nonadherent) and 12 providers and staff. We identified capability barriers to include external factors related to acquiring medications, specifically cost-, pharmacy-, and clinic-related issues; opportunity barriers to include external barriers to taking medications, specifically logistic- and medication-related issues; and motivation factors to include intrinsic barriers, encompassing patients' knowledge, beliefs, attitudes, and physical and mental health. The most frequently described barriers were cost, side effects, busyness/forgetting, and lack of understanding, although barriers differed by patient and adherence level, with logistic and intrinsic barriers described predominantly by nonadherent patients and side effects described predominantly by adherent patients. CONCLUSION: Our findings suggest that interventions may be most impactful if they are designed to facilitate logistics of taking medications and increase patients' motivation while allowing for personalization to address the individual differences in adherence barriers.

Stakeholder Experiences with the Single IRB Review Process and Recommendations for Food and Drug Administration Guidance.

The revised Common Rule requires using a single institutional review board (sIRB) for U.S.-based, multisite, nonexempt, federally conducted or supported research with human participants. The 21st Century Cures Act directs the Department of Health and Human Services (HHS) to harmonize differences between HHS and the U.S. Food and Drug Administration (FDA) regulations governing research with humans. Anticipating that the FDA may update its 2006 centralized IRB guidance, we conducted interviews with 34 stakeholders engaged in FDA-regulated clinical research to identify benefits and challenges of using sIRBs and to gather recommendations for revising the FDA's guidance. The main benefits were consistency and standardization, speed and efficiency, and streamlining and simplification. The main challenges were uncertainty at local institutions, including addressing local context; decreased timeliness of the research review process; variable processes; and insufficient communication. Several recommendations for FDA guidance focused on the local context and communication plans. Findings suggest that the sIRB review process may be gaining efficiency although challenges remain.

Development and Application of a Patient Group Engagement Prioritization Tool for Use in Medical Product Development.

INTRODUCTION: Patient group engagement is increasingly used to inform the design, conduct, and dissemination of clinical trials and other medical research activities. However, the priorities of industry sponsors and patient groups differ, and there is currently no framework to help these groups identify mutually beneficial engagement activities. METHODS: We conducted 28 qualitative, semi-structured interviews with representatives from research sponsor organizations (n = 14) and patient groups (n = 14) to determine: (1) how representatives define benefits and investments of patient group engagement in medical product development, and (2) to refine a list of 31 predefined patient group engagement activities. RESULTS: Patient group and sponsor representatives described similar benefits: engagement activities can enhance the quality and efficiency of clinical trials by improving patient recruitment and retention, reduce costs, and help trials meet expectations of regulators and payers. All representatives indicated that investments include both dedicated staff time and expertise, and financial resources. Factors to consider when evaluating benefits and investments were also identified as were suggestions for clarifying the list of engagement activities. DISCUSSION: Using these findings, we refined the 31 engagement activities to 24 unique activities across the medical product development lifecycle. We also developed a web-based prioritization tool ( https://prioritizationtool.ctti-clinicaltrials.org/ ) to help clinical research sponsors and patient groups identify high-priority engagement activities. Use of this tool can help sponsors and patient groups identify the engagement activities that they believe will provide the most benefit for the least investment and may lead to more meaningful and mutually beneficial partnerships in medical product development.

Pregnancy vs. paycheck: a qualitative study of patient's experience with employment during pregnancy at high risk for preterm birth.

BACKGROUND: Pregnant women with a history of preterm birth are at risk for recurrence, often requiring frequent prenatal visits for close monitoring and/or preventive therapies. Employment demands can limit uptake and adherence to recommended monitoring and preterm birth prevention therapies. METHOD: We conducted a qualitative descriptive study using in-depth interviews (IDIs) of pregnant women with a history of preterm birth. IDIs were conducted by trained qualitative interviewers following a semi-structured interview guide focused on uncovering barriers and facilitators to initiation of prenatal care, including relevant employment experiences, and soliciting potential interventions to improve prompt prenatal care initiation. The IDIs were analyzed via applied thematic analysis. RESULTS: We described the interview findings that address women's employment experiences. The current analysis includes 27 women who are majority self-described as non-Hispanic Black (74%) and publically insured (70%). Participants were employed in a range of professions; food services, childcare and retail were the most common occupations. Participants described multiple ways that being pregnant impacted their earning potential, ranging from voluntary work-hour reduction, involuntary duty hour reductions by employers, truncated promotions, and termination of employment. Participants also shared varying experiences with workplace accommodations to their work environment and job duties based on their pregnancy. Some of these accommodations were initiated by a collaborative employee/employer discussion, others were initiated by the employer's perception of safe working conditions in pregnancy, and some accommodations were based on medical recommendations. Participants described supportive and unsupportive employer reactions to requests for accommodations. CONCLUSIONS: Our findings provide novel insights into women's experiences balancing a pregnancy at increased risk for preterm birth with employment obligations. While many women reported positive experiences, the most striking insights came from women who described negative situations that ranged from challenging to potentially unlawful. Many of the findings suggest profound misunderstandings likely exist at the patient, employer and clinical provider level about the laws surrounding employment in pregnancy, safe employment responsibilities during pregnancy, and the range of creative accommodations that often allow for continued workplace productivity even during high risk pregnancy.

More than a box to check: Research sponsor and clinical investigator perspectives on making GCP training relevant.

BACKGROUND: Good clinical practice (GCP) training is the industry expectation for ensuring quality conduct of registrational clinical trials. However, concerns exist about whether the current structure and delivery of GCP training sufficiently prepares clinical investigators and their delegates to conduct clinical trials. METHODS: We conducted qualitative semi-structured interviews with 13 clinical investigators and 10 research sponsors to 1) examine characteristics of the quality conduct of sponsored clinical trials, including critical tasks and concerns perceived as essential for trial quality, 2) identify key knowledge and skills required to perform critical tasks, and 3) identify gaps and redundancies in GCP training and areas of improvement to ensure quality conduct of clinical trials. Data were examined using applied thematic analysis. RESULTS: The top three tasks identified as critical for the quality conduct of clinical trials were obtaining informed consent, ensuring protocol compliance, and protecting participants' health and safety. Respondents acknowledged that GCP principles address each of these critical tasks but also described many challenges and burdens of GCP training, including high training frequency and repetitive content. Respondents suggested moving beyond GCP training as a mere check-box activity by making it more effective, engaging, and interactive. They also emphasized that applying GCP principles in a real-world, skills-based environment would increase the perceived relevance of GCP training. CONCLUSION: Our findings indicate that although investigators and sponsors recognize that GCP training addresses tasks critical to the quality conduct of clinical trials, the need for significant improvement in the design, content, and presentation of GCP training remains.

Continued investigator engagement: Reasons principal investigators conduct multiple FDA-regulated drug trials.

BACKGROUND/AIMS: Numerous reasons have been identified for why U.S.-based principal investigators choose to not continue participating in FDA-regulated trials. However, unexplored are reasons why a substantial number of principal investigators, facing the same challenges, remain engaged in clinical research. This study aimed to both describe barriers and identify factors that contribute to active investigators' success in conducting multiple FDA-regulated trials. METHODS: We conducted qualitative in-depth interviews (IDIs) with "active" multi-trial investigators. Interviews focused on investigators' experiences with FDA-regulated drug trials, challenges faced, and factors contributing to success. Investigators also reflected on previously identified barriers and shared advice for new investigators. Narratives were analyzed using applied thematic analysis. RESULTS: We interviewed 23 experienced investigators, representing a variety of backgrounds. Most reported that demonstrated ability to conduct a trial led to being approached again by sponsors. Investigators cited infrastructure, staff support, advance planning, and personal qualities as key factors in successfully conducting multiple trials. Nearly all cited difficulties related to trial finances. Three-quarters pointed to challenges with patient recruitment; others described challenges related to data and safety reporting and to the time that trial implementation takes away from other activities. Aspiring investigators were advised to engage in research-specific training and seek out mentorship opportunities. CONCLUSION: Investigators in our sample faced many of the same challenges identified in previous research, yet they had evolved strategies to overcome them. The amount and type of support to which investigators have access may represent a crucial difference between "active" investigators and principal investigators who leave FDA-regulated trials.

Assessment of the Perceived Acceptability of an Early Enrollment Strategy Using Advance Consent in Health Care-Associated Pneumonia.

Importance: Better treatment options are needed in life-threatening infections, including health care-associated pneumonia. Enrolling patients in antibacterial clinical trials before diagnosis may circumvent existing time-to-enrollment constraints. However, the acceptability of an early enrollment strategy using advance consent is unknown. Objective: To assess the perceived acceptability of an early enrollment strategy for enrolling patients in an antibacterial clinical trial before a pneumonia diagnosis. Design, Setting, and Participants: This qualitative, descriptive study used semistructured telephone interviews. Framed within a planned noninferiority pneumonia antibiotic trial, an early enrollment strategy was described and perceptions were assessed. Using this strategy, patients give consent to enroll before developing pneumonia, to be monitored by study staff, and to be randomly assigned a study antibiotic if pneumonia develops. All interviews were audiorecorded, transcribed verbatim, and analyzed using applied thematic analysis. Fifty-two key stakeholders from across the United States, including 18 patients at risk of pneumonia, 12 caregivers, 10 representatives of institutional review boards, 7 investigators, and 5 study coordinators, were interviewed from June 20 to August 19, 2016. Main Outcomes and Measures: Perceived acceptability of the early enrollment strategy. Results: Among the 52 stakeholders interviewed (ages 29-75 years; 14 women), patients and caregivers expressed no concerns about patients being approached about participation before developing pneumonia; however, some patients may experience anxiety on learning about their risk for pneumonia. No concerns with study staff accessing patients' medical records were expressed. The clarity of consent information was important for understanding the study rather than having the condition under investigation. Among patients, caregivers, and institutional review board representatives, preferences varied regarding opt-out and precedent autonomy procedures. Nearly all patients would be willing to join a trial using the early enrollment strategy and caregivers would be willing to provide proxy consent. Institutional review board representatives were supportive of the strategy and made recommendations for the study protocol, primarily around informed consent. Investigators and study coordinators believed the strategy would not be burdensome and offered suggestions to ensure its feasibility. Conclusion and Relevance: Results of the study suggest that the early enrollment strategy is acceptable. Future research should evaluate whether the strategy improves enrollment rates in registrational pneumonia trials and in trials of other acute infection syndromes with narrow enrollment windows and/or patients with transient decisional incapacity.

Improving biobank consent comprehension: a national randomized survey to assess the effect of a simplified form and review/retest intervention.

PURPOSE: To determine the individual and combined effects of a simplified form and a review/retest intervention on biobanking consent comprehension. METHODS: We conducted a national online survey in which participants were randomized within four educational strata to review a simplified or traditional consent form. Participants then completed a comprehension quiz; for each item answered incorrectly, they reviewed the corresponding consent form section and answered another quiz item on that topic. RESULTS: Consistent with our first hypothesis, comprehension among those who received the simplified form was not inferior to that among those who received the traditional form. Contrary to expectations, receipt of the simplified form did not result in significantly better comprehension compared with the traditional form among those in the lowest educational group. The review/retest procedure significantly improved quiz scores in every combination of consent form and education level. Although improved, comprehension remained a challenge in the lowest-education group. Higher quiz scores were significantly associated with willingness to participate. CONCLUSION: Ensuring consent comprehension remains a challenge, but simplified forms have virtues independent of their impact on understanding. A review/retest intervention may have a significant effect, but assessing comprehension raises complex questions about setting thresholds for understanding and consequences of not meeting them.Genet Med advance online publication 13 October 2016.

Development and Initial Validation of the PROMIS(®) Sexual Function and Satisfaction Measures Version 2.0.

INTRODUCTION: The Patient-Reported Outcomes Measurement Information System (PROMIS)(®) Sexual Function and Satisfaction measure (SexFS) version 1.0 was developed with cancer populations. There is a need to expand the SexFS and provide evidence of its validity in diverse populations. AIM: The aim of this study was to describe the development of the SexFS v2.0 and present preliminary evidence for its validity. METHODS: Development built on version 1.0, plus additional review of extant items, discussions with 15 clinical experts, 11 patient focus groups (including individuals with diabetes, heart disease, anxiety, depression, and/or are lesbian, gay, bisexual, or aged 65 or older), 48 cognitive interviews, and psychometric evaluation in a random sample of U.S. adults plus an oversample for specific sexual problems (2281 men, 1686 women). We examined differential item functioning (DIF) by gender and sexual activity. We examined convergent and known-groups validity. RESULTS: The final set of domains includes 11 scored scales (interest in sexual activity, lubrication, vaginal discomfort, clitoral discomfort, labial discomfort, erectile function, orgasm ability, orgasm pleasure, oral dryness, oral discomfort, satisfaction), and six nonscored item pools (screeners, sexual activities, anal discomfort, therapeutic aids, factors interfering with sexual satisfaction, bother). Domains from version 1.0 were reevaluated and improved. Domains considered applicable across gender and sexual activity status, namely interest, orgasm, and satisfaction, were found to have significant DIF. We identified subsets of items in each domain that provided consistent measurement across these important respondent groups. Convergent and known-groups validity was supported. CONCLUSIONS: The SexFS version 2.0 has several improvements and enhancements over version 1.0 and other extant measures, including expanded evidence for validity, scores centered around norms for sexually active U.S. adults, new domains, and a final set of items applicable for both men and women and those sexually active with a partner and without. The SexFS is customizable, allowing users to select relevant domains and items for their study.

Informed consent for biobanking: consensus-based guidelines for adequate comprehension.

PURPOSE: Federal regulations and best practice guidelines identify categories of information that should be communicated to prospective biobank participants during the informed consent process. However, uncertainty remains about which of this information participants must understand to provide valid consent. METHODS: We conducted a Delphi process to define "adequate comprehension" in the context of biobanking consent. The process involved an iterative series of three online surveys of a diverse panel of 51 experts, including genome scientists, biobank managers, ethics and policy experts, and community and participant representatives. We sought consensus (>70% agreement) concerning what specific details participants should know about 16 biobank consent topics. RESULTS: Consensus was achieved for 15 of the 16 consent topics. The exception was the comprehension needed regarding the Genetic Information Nondiscrimination Act. CONCLUSION: Our Delphi process was successful in identifying a concise set of key points that prospective participants must grasp to provide valid consent for biobanking. Specifying the level of knowledge sufficient for individuals to make an informed choice provides a basis for improving consent forms and processes, as well as an absolute metric for assessing the effectiveness of other interventions to improve comprehension.Genet Med 17 3, 226-233.