Increasing enrollment in drug trials: the need for greater transparency about the social value of research in recruitment efforts.
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ABSTRACT:
SUBMITTER: Yarborough MA
PROVIDER: S-EPMC3729227 | biostudies-literature | 2013 May
REPOSITORIES: biostudies-literature
Publications
Increasing enrollment in drug trials: the need for greater transparency about the social value of research in recruitment efforts.
Mayo Clinic proceedings 20130501 5
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Project description:Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends.
| S-EPMC3246429 | biostudies-literature
Project description:Psychedelics have a checkered past, alternately venerated as sacred medicines and vilified as narcotics with no medicinal or research value. After decades of international prohibition, a growing dissatisfaction with conventional mental health care and the pioneering work of the Multidisciplinary Association for Psychedelic Science (MAPS) and others has sparked a new wave of psychedelic research. Positive media coverage and new entrepreneurial interest in this potentially lucrative market, along with their attendant conflicts of interest, have accelerated the hype. Given psychedelics' complex history, it is especially important to proceed with care, holding ourselves to a higher scientific rigor and standard of transparency. Universities and researchers face conflicting interests and perverse incentives, but we can avoid missteps by expecting rigorous and transparent methods in the growing science of psychedelics. This paper provides a pragmatic research checklist and discusses the importance of using the modern research and transparency standards of Open Science using preregistration, open materials and data, reporting constraints on generality, and encouraging replication. We discuss specific steps researchers should take to avoid another replication crisis like those devastating psychology, medicine, and other fields. We end with a discussion of researcher intention and the value of actively deciding to abide by higher scientific standards. We can build a rigorous, transparent, replicable psychedelic science by using Open Science to understand psychedelics' potential as they re-enter science and society.
| S-EPMC7367180 | biostudies-literature
Project description:BackgroundPoor recruitment to randomised controlled trials (RCTs) is a widespread and important problem. With poor recruitment being such an important issue with respect to the conduct of randomised trials, a systematic review of controlled trials on recruitment methods was undertaken in order to identify strategies that are effective.MethodsWe searched the register of trials in Cochrane library from 1996 to end of 2004. We also searched Web of Science for 2004. Additional trials were identified from personal knowledge. Included studies had to use random allocation and participants had to be allocated to different methods of recruitment to a 'real' randomised trial. Trials that randomised participants to 'mock' trials and trials of recruitment to non-randomised studies (e.g., case control studies) were excluded. Information on the study design, intervention and control, and number of patients recruited was extracted by the 2 authors.ResultsWe identified 14 papers describing 20 different interventions. Effective interventions included: telephone reminders; questionnaire inclusion; monetary incentives; using an 'open' rather than placebo design; and making trial materials culturally sensitive.ConclusionFew trials have been undertaken to test interventions to improve trial recruitment. There is an urgent need for more RCTs of recruitment strategies.
| S-EPMC1559709 | biostudies-literature
Project description:The methods and results of health research are documented in study protocols, full study reports (detailing all analyses), journal reports, and participant-level datasets. However, protocols, full study reports, and participant-level datasets are rarely available, and journal reports are available for only half of all studies and are plagued by selective reporting of methods and results. Furthermore, information provided in study protocols and reports varies in quality and is often incomplete. When full information about studies is inaccessible, billions of dollars in investment are wasted, bias is introduced, and research and care of patients are detrimentally affected. To help to improve this situation at a systemic level, three main actions are warranted. First, academic institutions and funders should reward investigators who fully disseminate their research protocols, reports, and participant-level datasets. Second, standards for the content of protocols and full study reports and for data sharing practices should be rigorously developed and adopted for all types of health research. Finally, journals, funders, sponsors, research ethics committees, regulators, and legislators should endorse and enforce policies supporting study registration and wide availability of journal reports, full study reports, and participant-level datasets.
| S-EPMC4533904 | biostudies-literature
Project description:BackgroundRecruitment of participants into randomised controlled trials (RCTs) is critical for successful trial conduct. Although there have been two previous systematic reviews on related topics, the results (which identified specific interventions) were inconclusive and not generalizable. The aim of our study was to evaluate the relative effectiveness of recruitment strategies for participation in RCTs.Methods and findingsA systematic review, using the PRISMA guideline for reporting of systematic reviews, that compared methods of recruiting individual study participants into an actual or mock RCT were included. We searched MEDLINE, Embase, The Cochrane Library, and reference lists of relevant studies. From over 16,000 titles or abstracts reviewed, 396 papers were retrieved and 37 studies were included, in which 18,812 of at least 59,354 people approached agreed to participate in a clinical RCT. Recruitment strategies were broadly divided into four groups: novel trial designs (eight studies), recruiter differences (eight studies), incentives (two studies), and provision of trial information (19 studies). Strategies that increased people's awareness of the health problem being studied (e.g., an interactive computer program [relative risk (RR) 1.48, 95% confidence interval (CI) 1.00-2.18], attendance at an education session [RR 1.14, 95% CI 1.01-1.28], addition of a health questionnaire [RR 1.37, 95% CI 1.14-1.66]), or a video about the health condition (RR 1.75, 95% CI 1.11-2.74), and also monetary incentives (RR1.39, 95% CI 1.13-1.64 to RR 1.53, 95% CI 1.28-1.84) improved recruitment. Increasing patients' understanding of the trial process, recruiter differences, and various methods of randomisation and consent design did not show a difference in recruitment. Consent rates were also higher for nonblinded trial design, but differential loss to follow up between groups may jeopardise the study findings. The study's main limitation was the necessity of modifying the search strategy with subsequent search updates because of changes in MEDLINE definitions. The abstracts of previous versions of this systematic review were published in 2002 and 2007.ConclusionRecruitment strategies that focus on increasing potential participants' awareness of the health problem being studied, its potential impact on their health, and their engagement in the learning process appeared to increase recruitment to clinical studies. Further trials of recruitment strategies that target engaging participants to increase their awareness of the health problems being studied and the potential impact on their health may confirm this hypothesis. Please see later in the article for the Editors' Summary.
| S-EPMC2976724 | biostudies-literature
Project description:BackgroundNearly 1 in 3 clinical trials end prematurely due to underenrollment. Strategies to enhance recruitment are often implemented without scientific rigor to evaluate efficacy. Evidence-based, cost-effective behavioral economic strategies designed to influence decision-making may be useful to promote clinical trial enrollment.ObjectiveThis study evaluated 2 behavioral economic strategies to improve enrollment and retention rates across 4 clinical trials: information provision (IP) and contingency management (CM; ie, lottery). IP targets descriptive and injunctive norms about participating in research and CM provides participants incentives to reinforce a target behavior.MethodsA sample of 212 participants was enrolled across 4 clinical trials focused on tobacco use: 2 focused on HIV and 2 focused on neuroimaging. The CM condition included a lottery: for each study visit completed, participants received 5 "draws" from a bowl containing 500 "chips" valued at US $0, US $1, US $5, or US $100. In the IP condition, text messages that targeted injunctive norms about research (eg, "Many find it a rewarding way to advance science and be part of a community") were sent through the Way to Health platform before all study visits. Participants were randomized to 1 of 4 conditions: IP, CM, IP+CM, or standard recruitment (SR). We performed logistic regression, controlling for sex and study, with condition as a between-subject predictor. Outcomes were the percentage of participants who attended a final eligibility visit (primary), met intent-to-treat (ITT) criteria (secondary), and completed the study (secondary). Recruitment was evaluated by the percentage of participants who attended a final eligibility visit, enrollment by ITT status, and retention by the percentage of participants who completed the study.ResultsRates of attending the eligibility visit and meeting ITT status were 58.9% (33/56) and 33.9% (19/56) for IP+CM; 45.5% (25/55) and 18.2% (10/55) for IP only; 41.5% (22/53) and 18.9% (10/53) for CM only; and 37.5% (18/48) and 12.5% (6/48) for SR, respectively. In the logistic regression, females were more likely to meet ITT status than males (odds ratio [OR] 2.7, 95% CI 1.2-5.7; P=.01). The IP+CM group was twice as likely to attend the final eligibility visit than the SR group (OR 2.4, 95% CI 1.1-5.2; P=.04). The IP+CM group was also significantly more likely to reach ITT status than the SR condition (OR 3.9, 95% CI 1.3-11.1; P=.01). Those who received any active intervention (IP, CM, or IP+CM) had a higher study completion rate (33/53, 63.5%) compared to those who received SR (5/12, 41.7%), but this difference was not significant (P=.26).ConclusionsCombining IP and CM strategies may motivate participants to participate in research and improve recruitment and retention rates. Evidence from this study provides preliminary support for the utility of behavioral economics strategies to improve enrollment and reduce attrition in clinical trials.
| S-EPMC10403799 | biostudies-literature
Project description:PurposeThis study aimed to evaluate the quality of artificial intelligence (AI)/machine learning (ML) studies on hemorrhagic stroke using the Minimum Information for Medical AI Reporting (MINIMAR) and Minimum Information About Clinical Artificial Intelligence Modeling (MI-CLAIM) frameworks to promote clinical application.Materials and methodsPubMed, MEDLINE, and Embase were searched for AI/ML studies on hemorrhagic stroke. Out of the 531 articles found, 29 relevant original research articles were included. MINIMAR and MI-CLAIM scores were assigned by two experienced radiologists to assess the quality of the studies.ResultsWe analyzed 29 investigations that utilized AI/ML in the field of hemorrhagic stroke, involving a median of 224.5 patients. The majority of studies focused on diagnostic outcomes using computed tomography scans (89.7%) and were published in computer science journals (48.3%). The overall adherence rates to reporting guidelines, as assessed through the MINIMAR and MI-CLAIM frameworks, were 47.6% and 46.0%, respectively. In MINIMAR, none of the studies reported the socioeconomic status of the patients or how missing values had been addressed. In MI-CLAIM, only two studies applied model-examination techniques to improve model interpretability. Transparency and reproducibility were limited, as only 10.3% of the studies had publicly shared their code. Cohen's kappa between the two radiologists was 0.811 and 0.779 for MINIMAR and MI-CLAIM, respectively.ConclusionThe overall reporting quality of published AI/ML studies on hemorrhagic stroke is suboptimal. It is necessary to incorporate model examination techniques for interpretability and promote code openness to enhance transparency and increase the clinical applicability of AI/ML studies.
| S-EPMC11427125 | biostudies-literature
Project description:BackgroundPatient and public involvement work (PPI) is essential to good research practice. Existing research indicates that PPI offers benefits to research design, conduct, communication, and implementation of findings. Understanding how PPI works and its value helps to provide information about best practice and highlight areas for further development. This study used a values-based approach to reporting PPI at a Research Unit focused on musculoskeletal conditions within a UK medical school.MethodsThe study was conducted between October 2019 and January 2020 using Gradinger's value system framework as a theoretical basis. The framework comprises three value systems each containing five clusters. All PPI members and researchers who had attended PPI groups were invited to participate. Participants completed a structured questionnaire based on the value system framework; PPI members also provided further information through telephone interviews. Data were deductively analysed using a framework approach with data mapped onto value systems.ResultsTwelve PPI members and 17 researchers took part. Views about PPI activity mapped onto all three value systems. PPI members felt empowered to provide their views, and that their opinions were valued by researchers. It was important to PPI members that they were able to 'give back' and to do something positive with their experiences. Researchers would have liked the groups to be more representative of the wider population, patients highlighted that groups could include more younger members. Researchers recognised the value of PPI, and the study highlighted areas where researchers members might benefit from further awareness.ConclusionsThree areas for development were identified: (i) facilitating researcher engagement in training about the value and importance of PPI in research; (ii) support for researchers to reflect on the role that PPI plays in transparency of healthcare research; (iii) work to further explore and address aspects of diversity and inclusion in PPI.
| S-EPMC8635367 | biostudies-literature
Project description:ObjectiveTo describe recruitment and enrollment experiences of 2 low back pain (LBP) randomized controlled trials (RCTs).DesignDescriptive report.SettingChiropractic research center in the midwest United States that is not a fee-for-service clinic.ParticipantsBoth trials enrolled participants with subacute or chronic LBP without neurologic signs who had not received spinal manipulative care during the previous month. For study 1 we screened 1940 potential participants to enroll 192 participants (89 women and 103 men), mean age 40.0 +/- 9.4 years (range, 21-54 years). For study 2 we screened 1849 potential participants to enroll 240 participants (105 women and 135 men) at least 55 years old (mean, 63.1 +/- 6.7 years).InterventionsStudy 1 randomly assigned participants to 2 weeks of 2 different chiropractic techniques or a wait list control group. Study 2 randomly assigned participants to 6 weeks of 2 different chiropractic techniques or medical care consisting of 3 provider visits for medications.Outcome measuresRecruitment source costs and yield, and baseline characteristics of enrolled versus nonparticipants were recorded.ResultsWe conducted 3789 telephone screens for both trials to enroll 432 (11%) participants, at a cost in excess of $156,000 for recruitment efforts. The cost per call for all callers averaged $41, ranging from $4 to $300 based on recruitment method; for enrolled participants, the cost per call was $361, ranging from $33 to $750. Direct mail efforts accounted for 62% of all callers, 57% for enrolled participants, and had the second lowest cost per call for recruitment efforts.ConclusionsIt is important that complementary and alternative medicine (CAM) research can be successfully conducted at CAM institutions. However, the costs associated with recruitment efforts for studies conducted at CAM institutions may be higher than expected and many self-identified participants are users of the CAM therapy. Therefore, strategies for efficient recruitment methods and targeting nonusers of CAM therapies should be developed early for CAM trials.
| S-EPMC3116528 | biostudies-literature
Project description:ObjectiveTo estimate the incremental associations between the implementation of expanded Medicaid eligibility and prerelease Medicaid enrollment assistance on Medicaid enrollment for recently incarcerated adults.Data sources/study settingData include person-level merged, longitudinal data from the Wisconsin Department of Corrections and the Wisconsin Medicaid program from 2013 to 2015.Study designWe use an interrupted time series design to estimate the association between each of two natural experiments and Medicaid enrollment for recently incarcerated adults. First, in April 2014 the Wisconsin Medicaid program expanded eligibility to include all adults with income at or below 100% of the federal poverty level. Second, in January 2015, the Wisconsin Department of Corrections implemented prerelease Medicaid enrollment assistance at all state correctional facilities.Data collection/extraction methodsWe collected Medicaid enrollment, and state prison administrative and risk assessment data for all nonelderly adults incarcerated by the state who were released between January 2013 and December 2015. The full sample includes 24 235 individuals. Adults with a history of substance use comprise our secondary sample. This sample includes 12 877 individuals. The primary study outcome is Medicaid enrollment within the month of release.Principal findingsMedicaid enrollment in the month of release from state prison grew from 8 percent of adults at baseline to 36 percent after the eligibility expansion (P-value < .01) and to 61 percent (P-value < .01) after the introduction of enrollment assistance. Results were similar for adults with a history of substance use. Black adults were 3.5 percentage points more likely to be enrolled in Medicaid in the month of release than White adults (P-value < .01).ConclusionsMedicaid eligibility and prerelease enrollment assistance are associated with increased Medicaid enrollment upon release from prison. States should consider these two policies as potential tools for improving access to timely health care as individuals transition from prison to community.
| S-EPMC8313952 | biostudies-literature