Contemp Clin Trials

ObjectiveOnline crowdsourcing refers to the process of obtaining needed services, ideas, or content by soliciting contributions from a large group of people over the Internet. We examined the potential for using online crowdsourcing methods for conducting behavioral health intervention research among people with serious mental illness (SMI).MethodsSystematic review of randomized trials using online crowdsourcing methods for recruitment, intervention delivery, and data collection in people with SMI, including schizophrenia spectrum disorders and mood disorders. Included studies were completed entirely over the Internet without any face-to-face contact between participants and researchers.Databases and sourcesMedline, Cochrane Library, Web of Science, CINAHL, Scopus, PsychINFO, Google Scholar, and reference lists of relevant articles.ResultsWe identified 7 randomized trials that enrolled N=1,214 participants (range: 39 to 419) with SMI. Participants were mostly female (72%) and had mood disorders (94%). Attrition ranged from 14% to 81%. Three studies had attrition rates below 25%. Most interventions were adapted from existing evidence-based programs, and consisted of self-directed education, psychoeducation, self-help, and illness self-management. Six studies collected self-reported mental health symptoms, quality of life, and illness severity. Three studies supported intervention effectiveness and two studies showed improvements in the intervention and comparison conditions over time. Peer support emerged as an important component of several interventions. Overall, studies were of medium to high methodological quality.ConclusionOnline crowdsourcing methods appear feasible for conducting intervention research in people with SMI. Future efforts are needed to improve retention rates, collect objective outcome measures, and reach a broader demographic.R01 MH104555/MH/NIMH NIH HHS/United StatesU48 DP005018/DP/NCCDPHP CDC HHS/United States2017-01-16T00:00:00Z26188164PMC471579

IDENTIFYING THE COMMON BARRIERS OF PATIENT RECRUITMENT AND RETENTION OF WOMEN IN HIV/AIDS CLINICAL TRIALS TO DETERMINE THE BEST PRACTICES IN MINIMIZING UNDER-ENROLLMENT AND WITHDRAWS FROM CLINICAL STUDIES

Purpose: Many past human immunodeficiency virus (HIV) clinical trials have struggled to recruit and retain female participants due to their encounters with potential barriers that prevented the participants’ initial or continued involvement in the clinical trials. Patient recruitment and retention rates are crucial to the success of clinical research trials. The objective of this study was to identify common barriers to recruitment and retention of female participants and to identify the common best practices used to address these barriers. Methods A literature search was conducted to identify articles relating to the recruitment and retention of female participants in HIV/AIDS clinical trials. Keywords and search terms were used in PubMed, BASE (Bielefeld Academic Search Engine), and Web of Science. A total of 48 articles were found and narrowed down using 17 out of the 27 checklist items provided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) to help determine each article’s eligibility for inclusion in this study. Results: In the twenty-five articles selected for this study, eight common recruitment and retention barriers were identified. Researchers addressed these barriers by utilizing several common best practices to improve recruitment and retention rates. Conclusion: By implementing the best practices found in this study, healthcare providers and researchers will be able to overcome the challenges in recruiting and retaining female participants in future HIV/AIDS clinical trials

Promoting participation in remote digital health studies: An expert interview study

BACKGROUND Remote digital health studies are on the rise and promise to reduce the operational inefficiencies of in-person research. However, they encounter specific challenges in maintaining participation (enrollment and retention) due to their exclusive reliance on technology across all study phases. OBJECTIVE The goal of this study was to collect experts' opinions on how to facilitate participation in remote digital health studies. METHOD We conducted 13 semi-structured interviews with principal investigators, researchers, and software developers who had recent experiences with remote digital health studies. Informed by the Unified Theory of Acceptance and Use of Technology (UTAUT) framework, we performed a thematic analysis and mapped various approaches to successful study participation. RESULTS Our analyses revealed four themes: (1) study planning to increase participation, where experts suggest that remote digital health studies should be planned based on adequate knowledge of what motivates, engages, and disengages a target population; (2) participant enrollment, highlighting that enrollment strategies should be selected carefully, attached to adequate support, and focused on inclusivity; (3) participant retention, with strategies that minimize the effort and complexity of study tasks and ensure that technology is adapted and responsive to participant needs, and (4) requirements for study planning focused on the development of relevant guidelines to foster participation in future studies. CONCLUSIONS Our findings highlight the significant requirements for seamless technology and researcher involvement in enabling high remote digital health study participation. Future studies can benefit from collected experiences and the development of guidelines to inform planning that balances participant and scientific requirements

Mizzou Advantage grants awarded : round two

Date of publication unknownDate of publication unknownFor the second round of Mizzou Advantage grants, nearly 140 proposals were received totaling over $5 million in requests. Mizzou Advantage will fund 16 seed and 12 network projects; additionally, the Chancellor's Fund for Excellence will fund ten projects that have potential for major external collaborations and/or have major components in the Arts and Humanities. In all, 38 projects have been funded for a total of slightly more than$1.4 million

The history and future of digital health in the field of behavioral medicine.

Since its earliest days, the field of behavioral medicine has leveraged technology to increase the reach and effectiveness of its interventions. Here, we highlight key areas of opportunity and recommend next steps to further advance intervention development, evaluation, and commercialization with a focus on three technologies: mobile applications (apps), social media, and wearable devices. Ultimately, we argue that future of digital health behavioral science research lies in finding ways to advance more robust academic-industry partnerships. These include academics consciously working towards preparing and training the work force of the twenty first century for digital health, actively working towards advancing methods that can balance the needs for efficiency in industry with the desire for rigor and reproducibility in academia, and the need to advance common practices and procedures that support more ethical practices for promoting healthy behavior

Virtual Clinical Trials: One Step Forward, Two Steps Back

Virtual clinical trials have entered the medical research landscape. Today’s clinical trials recruit subjects online, obtain informed consent online, send treatments such as medications or devices to the subjects’ homes, and require subjects to record their responses online. Virtual clinical trials could be a way to democratize clinical research and circumvent geographical limitations by allowing access to clinical research for people who live far from traditional medical research centers. But virtual clinical trials also depart dramatically from traditional medical research studies in ways that can harm individuals and the public at large. This article addresses the issues presented by virtual clinical trials with regard to: (1) recruitment methods; (2) informed consent; (3) confidentiality; (4) potential risks to the subjects; and (5) the safety and efficacy of treatments that are approved

MANTRAM FOR MAMAS: A PILOT STUDY FOR POSTPARTUM WOMEN

Objective: This pilot study launched an online Mantram Repetition Program (oMRP) using a virtual health portal that aimed to explore online portal accessibility, oMRP acceptance, and overall interface satisfaction among a sample of postpartum women. Background: Postpartum depression remains one of the most common and severe childbirth complications, affecting more than 13% of women during the first three months after childbirth. Cognitive or behavioral talk therapy sessions and medication are the most frequently recommended treatments to alleviate symptoms. Although effective, women tend not to enroll or adhere to these modalities, suggesting they need alternative treatment plans. A possible alternative, mirroring the adoption of online platforms and patient portals in many areas of healthcare delivery, is to examine if an online treatment method is acceptable for women in the postpartum period. Methods: To explore whether newly postpartum women would log on, navigate the portal, accept the virtual program, and enjoy the overall experience, participants were invited to access four oMRP learning modules through a HIPAA-compliant portal during a 30-day study period. Participants provided sociodemographic data and completed satisfaction surveys throughout the study. Questions from the Technology Acceptance Model (TAM) and the Client Satisfaction Questionnaire (CSQ-8), in combination with open-ended questions, were used to evaluate participant acceptance and satisfaction with the technology, portal, and program. Results: Among this sample of seven women, five completed the program in its entirety, shared their satisfaction, and even expressed gratitude for the program. The women accepted the technology as indicated by a 6.0 mean TAM score (out of a possible 7.0) and had moderate to high levels of program satisfaction indicated by a 27 mean CSQ score (out of a possible 32). The qualitative and quantitative results indicated that the pilot study positively impacted its participants. Conclusion: The oMRP for postpartum women has the potential to be a patient-centered modality to treat postpartum symptoms and support overall well-being. This study provided a foundational empirical understanding of the acceptability and use of the oMRP interface, resulting in recommendations for future research, interface design, and clinical implementation

Leveraging electronic health records for clinical research

Electronic health records (EHRs) can be a major tool in the quest to decrease costs and timelines of clinical trial research, generate better evidence for clinical decision making, and advance health care. Over the past decade, EHRs have increasingly offered opportunities to speed up, streamline, and enhance clinical research. EHRs offer a wide range of possible uses in clinical trials, including assisting with prestudy feasibility assessment, patient recruitment, and data capture in care delivery. To fully appreciate these opportunities, health care stakeholders must come together to face critical challenges in leveraging EHR data, including data quality/completeness, information security, stakeholder engagement, and increasing the scale of research infrastructure and related governance. Leaders from academia, government, industry, and professional societies representing patient, provider, researcher, industry, and regulator perspectives convened the Leveraging EHR for Clinical Research Now! Think Tank in Washington, DC (February 18-19, 2016), to identify barriers to using EHRs in clinical research and to generate potential solutions. Think tank members identified a broad range of issues surrounding the use of EHRs in research and proposed a variety of solutions. Recognizing the challenges, the participants identified the urgent need to look more deeply at previous efforts to use these data, share lessons learned, and develop a multidisciplinary agenda for best practices for using EHRs in clinical research. We report the proceedings from this think tank meeting in the following paper

Addressing cancer survivors\u27 cardiovascular health using the Automated Heart Health Assessment (AH-HA) EHR tool: Initial protocol and modifications to address COVID-19 challenges

BACKGROUND: The purpose of this paper is to describe the Automated Heart-Health Assessment (AH-HA) study protocol, which demonstrates an agile approach to cancer care delivery research. This study aims to assess the effect of a clinical decision support tool for cancer survivors on cardiovascular health (CVH) discussions, referrals, completed visits with primary care providers and cardiologists, and control of modifiable CVH factors and behaviors. The COVID-19 pandemic has caused widespread disruption to clinical trial accrual and operations. Studies conducted with potentially vulnerable populations, including cancer survivors, must shift towards virtual consent, data collection, and study visits to reduce risk for participants and study staff. Studies examining cancer care delivery innovations may also need to accommodate the increased use of virtual visits. METHODS/DESIGN: This group-randomized, mixed methods study will recruit 600 cancer survivors from 12 National Cancer Institute Community Oncology Research Program (NCORP) practices. Survivors at intervention sites will use the AH-HA tool with their oncology provider; survivors at usual care sites will complete routine survivorship visits. Outcomes will be measured immediately after the study visit, with follow-up at 6 and 12 months. The study was amended during the COVID-19 pandemic to allow for virtual consent, data collection, and intervention options, with the goal of minimizing participant-staff in-person contact and accommodating virtual survivorship visits. CONCLUSIONS: Changes to the study protocol and procedures allow important cancer care delivery research to continue safely during the COVID-19 pandemic and give sites and survivors flexibility to conduct study activities in-person or remotely

A Multilevel Mixed Methods Examination of Treatment Nonadherence Among Rural Cancer Survivors

While mortality rates have been decreasing over the last 40 years, cancer remains a leading cause of death in the United States. Over 1.7 million people were diagnosed with cancer in 2019, and there were more than 600,000 cancer deaths. Of the 15 million cancer survivors in the US, nearly 3 million reside in rural areas and experience 3% higher cancer incidence and 10% higher cancer mortality compared to their nonrural counterparts. During 2006-2015, the annual age-adjusted mortality rates for all cancer sites combined decreased at a slower pace in rural areas versus nonrural areas (-1.0% vs -1.6% per year, respectively), widening the disparity in mortality rates. Although the reasons for these disparities are not fully known, rural cancer survivors tend to be older, have additional comorbidities and poorer general health, and have a higher prevalence of lifestyle risk factors, such as smoking and lack of physical activity, that complicate survival and may contribute to the higher mortality rate. Nonadherence to cancer treatment is associated with poorer cancer outcomes, including higher rates of cancer recurrence or treatment failure and decreased survival. Reports of mortality have been up to four times as likely in nonadherent compared with adherent survivors. A growing set of studies have begun to document that cancer treatment adherence is poorer among rural populations, which may also partially explain the higher mortality rate observed in rural areas. This dissertation is comprised of three studies: 1) a systematic review of the role of digital health in rural oncology; 2) a data analysis of hospital and billing claims data examining geographic differences in sociodemographic and clinical factors associated with radiation treatment nonadherence; and 3) a multilevel, theory-driven examination of rural cancer treatment nonadherence utilizing survey and individual interview data