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A novel protocol for streamlined IRB review of Practice-based Research Network (PBRN) card studies.

ABSTRACT: The "card study," in which clinicians record brief information about patient visits during usual clinical care, has long been a rapid method for conducting descriptive studies in practice-based research networks. Because an increasingly stringent regulatory environment has made conducting card studies difficult, we developed a streamlined method for obtaining card study institutional review board (IRB) approval.We developed a protocol for a study of the card study method, allowing new card study proposals of specific research questions to be submitted as addenda to the approved Card Study Protocol.Seven card studies were proposed and approved under the Card Study Protocol during the first year after implementation, contrasted with one-card study proposed in the previous year. New card study ideas submitted as addenda to an approved protocol appeared to increase IRB comfort with the card study as a minimal risk method while reducing the hurdles to developing new study ideas.A Card Study Protocol allowing new study questions to be submitted as addenda decreases time between idea generation and IRB approval. Shortened turn-around times may be useful for translating ideas into action while reducing regulatory burden.

SUBMITTER: Hamilton MD

PROVIDER: S-EPMC4331110 | biostudies-literature | 2011 Sep-Oct

REPOSITORIES: biostudies-literature

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A novel protocol for streamlined IRB review of Practice-based Research Network (PBRN) card studies.

Hamilton Michelle D MD Cola Philip A PA Terchek Joshua J JJ Werner James J JJ Stange Kurt C KC

Journal of the American Board of Family Medicine : JABFM 20110901 5

<h4>Purpose</h4>The "card study," in which clinicians record brief information about patient visits during usual clinical care, has long been a rapid method for conducting descriptive studies in practice-based research networks. Because an increasingly stringent regulatory environment has made conducting card studies difficult, we developed a streamlined method for obtaining card study institutional review board (IRB) approval.<h4>Methods</h4>We developed a protocol for a study of the card study ...[more]

PMID: 21900445

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Project description:BackgroundThe conceptualization of the home as a care environment and maintaining a high standard of care requires different professionals to collaborate. This study will explore collaborative practice in home care, needs and expectations of the stakeholders involved, and identify their roles and tasks. Secondly, it will investigate possible strategies to improve home care management and, more particularly, optimize collaborative practice in home care.MethodsThe study will be conducted during three distinct consecutive phases, within a multiphase mixed-methods design. Phase 1 will use a quantitative approach in which a social network analysis will be conducted to have an overview of collaborative practice in home care in French-speaking Switzerland. Phases 2 and 3 will be qualitative and focus on three different situations involving different locations (rural and urban) and different home care functioning (home care provided by agencies and home care providing by independent caregivers). In each situation, semi-structured interviews will be conducted with home care recipients and their home caregivers. In phase 2, results of phase 1's network analysis will be discussed, such as roles, needs, and expectations of all stakeholders involved in home care. In phase 3, phase 2's findings will be discussed and strategies to improve home care and to optimize collaborative practice will be explored.DiscussionOver the past years, home care has grown considerably. Therefore, more and more different caregivers are involved in the recipients' homes. Since optimal coordination between these different caregivers is a prerequisite for quality and safe care, it is essential to investigate the existing collaborative practice and how it is functioning. This study will provide knowledge on roles, needs and expectations of different caregivers involved in home care. It will also allow for strategies to optimize collaborative practice and thus ensure comprehensive care for recipients. Finally, it will serve as a basis for future studies that can be conducted to address identified needs.

Project description:Integrative medicine (IM) provides patient-centered care and addresses the full range of physical, emotional, mental, social, spiritual, and environmental influences that affect a person's health. IM is a "whole systems" approach that employs multiple modalities as opposed to an isolated complementary therapy. Thus, studying outcomes of IM is more challenging than evaluating an isolated intervention. Practice-based research networks (PBRNs) allow for clinicians/investigators at multiple diverse sites using common methodology to pool their data, increase participant sample size and increase generalizability of results. To conduct real-world, practice-based research, the Bravewell Collaborative founded BraveNet in 2007 as the first national integrative medicine PBRN.Patients Receiving Integrative Medicine Effectiveness Registry (PRIMIER) is a prospective, non-randomized, observational evaluation conducted at fourteen clinical sites. Participants receive a non-standardized, personalized, multimodal IM approach for various medical conditions. Using the REDCap electronic platform, an anticipated 10,000 study participants will complete patient-reported outcome measures including Patient Reported Outcomes Measurement Information System (PROMIS)-29, Perceived Stress Scale-4, and the Patient Activation Measure at baseline, 2, 4, 6, 12, 18 and 24 months. Extractions from participants' electronic health records include IM services received, as well as ICD diagnostic codes, and CPT billing codes associated with each IM visit. Repeated-measures analyses will be performed on data to assess change from baseline through 24 months with planned subgroup analyses to include specific clinical population and specific IM intervention or combinations.As the PRIMIER registry grows, we anticipate that our results would provide an indication of the promise of PBRN research efforts in IM. Analyses will incorporate a large sample of participants and an expected 10-year observation period and will provide the ability to evaluate the effect of IM on outcomes for specific clinical populations and specific IM interventions or combinations. As such, PRIMIER will serve as a national platform for future evaluations of IM best practices.Clinical Trials.gov NCT01754038.

Project description:Background/aimsObtaining ethical approval from multiple institutional review boards is a long-standing challenge to multi-site clinical trials and often leads to significant delays in study activation and enrollment. As of 25 January 2018, the National Institutes of Health began requiring use of a single institutional review board for US multi-site trials. To learn more and further inform the research and regulatory communities around aspects of transitioning to single institutional review board review, this study evaluated the efficiency, resource use, and user perceptions of a nascent institutional review board reliance model (Streamlined, Multi-site, Accelerated Resources for Trials IRB Reliance).MethodsThis research was embedded within the Influenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure trial-a multi-site trial of two influenza vaccine formulations. In the first year of the trial, a sample of sites agreed to use the developing Streamlined, Multi-site, Accelerated Resources for Trials IRB Reliance model and participated in its evaluation. In keeping with a least burdensome approach, short surveys were developed and obtained from each reporting entity (relying sites, non-relying site, lead site, and reviewing institutional review board). Data regarding time to institutional review board approval and site activation, costs, and user perceptions of reliant review were self-reported and collected via the survey form. Quantitative and qualitative analyses were performed, with costs analyzed as actual versus estimated due to the lack of established baseline cost data.ResultsA total of 13 sites ceded review and received institutional review board approval. Mean time to approval was substantially faster in sites that ceded review using the Streamlined, Multi-site, Accelerated Resources for Trials IRB Reliance model versus the site that did not cede review (81 vs 121 days). The mean time to approval was also faster than published averages for academic medical centers (81 vs 103 days). Time to first enrollment was faster for ceding sites versus the non-ceding site, and also faster than published averages (126 vs 149 and 169 days, respectively). Costs were higher than estimates for local institutional review board review and approval. Nearly half (47%) the stakeholders reported being very satisfied or satisfied with the reliance experience, although many noted the challenge related to institutional culture change.ConclusionImplementation of a single institutional review board represents a shift in practice and culture for many institutions. Evaluation of the reliance arrangements for this study highlights both the potential of, and challenges for, institutions as they transition to single institutional review board review. Although efficiencies were observed for study start-up, we anticipate a learning curve as institutions and research teams implement necessary process and resource changes to adapt to single institutional review board oversight. Findings may inform research teams but are, however, limited by the relatively small number of sites and lack of a control group.

Project description:BackgroundDespite general practitioners' (GPs') key role in Germany`s primary health care, clinical research in general practice is scarce. Clinical research is mainly conducted at inpatient facilities, although their results are rarely transferable. German GPs have no extra time or funding for research, as well as limited research training. To support clinical research in German primary health care, practice-based research networks (PBRNs) are developed. As they will be based on an active involvement of GPs, we need more information on GPs` participation-readiness. The aim of this study was to explore facilitators and barriers to participation in the Bavarian Research Practice Network (BayFoNet) from the GPs`perspective before clinical trials will be performed.MethodsWe have performed semi-structured qualitative interviews with a purposive sample of 20 Bavarian GPs in 2022 under the application of the consolidated framework for implementation research (CFIR). Transcriptions were analysed according to Kuckartz` qualitative content analysis. The five domains of the CFIR framework served as initial deductive codes.ResultsN = 14 interviewees already agreed to participate in BayFoNet, whereas n = 6 interviewees opted not to participate in BayFoNet at the time of data collection. Main facilitators to conduct clinical research within BayFoNet were the motivation to contribute to evidence strength and quality in general practice, professional development and training of practice staff, as well as networking. Barriers for an active participation were bad experiences with previous clinical studies and lack of resources.ConclusionsPBRNS in Germany have to be promoted and the entire practice team has to be involved at an early stage of development. Professional training of general practice staff and a living network might enhance engagement. Participatory approaches could help to develop acceptable and feasible study designs. Furthermore, PBRNs should support patient recruitment and data collection in general practices and disseminate the results of their research projects regularly to maintain GPs` engagement.Trial registrationDRKS00028805, NCT05667207.

Dataset Information

A novel protocol for streamlined IRB review of Practice-based Research Network (PBRN) card studies.

Publications

A novel protocol for streamlined IRB review of Practice-based Research Network (PBRN) card studies.

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