Cluster randomized trials to study the comparative effectiveness of therapeutics: stakeholders' concerns and recommendations

Mazor, Kathleen M.; Sabin, James E.; Goff, Sarah L.; Smith, David H.; Rolnick, Sharon J.; Roblin, Douglas W.; Raebel, Marsha A.; Herrinton, Lisa J.; Gurwitz, Jerry H.; Boudreau, Denise M.; Meterko, Vanessa; Dodd, Katherine; Platt, Richard

doi:10.1002/pds.1754

Cited by 13 publications

(10 citation statements)

References 19 publications

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“…This suggests that persons want to be asked for permission to participate in such research regardless of whether it affects treatment decisions. These findings are consistent with other studies that reveal broad support for, and willingness to participate in, research (27) but also a strong desire to be asked for permission before research using medical records (28), biospecimens (29, 30), or cluster randomization (31). These data also suggest that, unlike the OHRP’s interpretation of the federal regulations, the public does not base disclosure preferences about research solely on whether the research plan determines treatment assignment.…”

Section: Discussionsupporting

confidence: 91%

Attitudes Toward Risk and Informed Consent for Research on Medical Practices

et al. 2015

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Background The U.S. Office for Human Research Protections has proposed that end points of randomized trials comparing the effectiveness of standard medical practices are risks of research that would require disclosure and written informed consent, but data are lacking on the views of potential participants. Objective To assess attitudes of U.S. adults about risks and preferences for notification and consent for research on medical practices. Design Cross-sectional survey conducted in August 2014. Setting Web-based questionnaire. Patients 1095 U.S. adults sampled from an online panel (n = 805) and an online convenience river sample (n = 290). Measurements Attitudes toward risk, informed consent, and willingness to participate in 3 research scenarios involving medical record review and randomization of usual medical practices. Results 97% of respondents agreed that health systems should evaluate standard treatments. Most wanted to be asked for permission to participate in each of 3 scenarios (range, 75.2% to 80.4%), even if it involved only medical record review, but most would accept nonwritten (oral) permission or general notification if obtaining written permission would make the research too difficult to conduct (range, 70.2% to 82.7%). Most perceived additional risk from each scenario (range, 64.0% to 81.6%). Limitation Use of hypothetical scenarios and a nonprobability sample that was not fully representative of the U.S. population. Conclusion Most respondents preferred to be asked for permission to participate in observational and randomized research evaluating usual medical practices, but they are willing to accept less elaborate approaches than written consent if research would otherwise be impracticable. These attitudes are not aligned with proposed regulatory guidance. Primary Funding Source National Center for Advancing Translational Sciences at the National Institutes of Health.

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Section: Discussionsupporting

confidence: 91%

Attitudes Toward Risk and Informed Consent for Research on Medical Practices

et al. 2015

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“…One example is the ORBIT-atrial fibrillation (AF) registry, a multicenter prospective outpatient registry of patients with incident or prevalent AF to analyze treatment patterns and outcomes in the United States. 126 PRO questionnaires will be administered to a subsample of approximately 1500 patients to assess outcomes including AF quality of life, anticoagulation treatment satisfaction, caregiver assistance, comorbidities, and adherence.…”

Section: Registriesmentioning

confidence: 99%

The Use of Patient-reported Outcomes (PRO) Within Comparative Effectiveness Research

et al. 2012

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“… 70 Four studies have assessed the interest and concerns of HMO leaders, clinicians, and members about traditional or cluster-randomized trials within the health plan. 71 – 74 Clinicians were enthusiastic about participation as long as their time demands were not excessive and research staff could complete IRB applications and manage timelines and budgets on their behalf. 71 , 73 Organizational leaders raised concerns about the financial impact of clinical trials, the alignment of trials with their organizational mission, and the impact on member satisfaction of informing members about their eligibility for trials.…”

Section: Elements Of Sustainability For Scientific Networkmentioning

confidence: 99%

Sustaining Research Networks: the Twenty-Year Experience of the HMO Research Network

Steiner¹,

Paolino²,

Thompson³

et al. 2014

eGEMs

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Purpose:As multi-institutional research networks assume a central role in clinical research, they must address the challenge of sustainability. Despite its importance, the concept of network sustainability has received little attention in the literature, and the sustainability strategies of durable scientific networks have not been described.Innovation:The Health Maintenance Organization Research Network (HMORN) is a consortium of 18 research departments in integrated health care delivery systems with over 15 million members in the United States and Israel. The HMORN has coordinated federally funded scientific networks and studies since 1994. This case study describes the HMORN approach to sustainability, proposes an operational definition of network sustainability, and identifies 10 essential elements that can enhance sustainability.Credibility:The sustainability framework proposed here is drawn from prior publications on organizational issues by HMORN investigators and from the experience of recent HMORN leaders and senior staff.Conclusion and Discussion:Network sustainability can be defined as (1) the development and enhancement of shared research assets to facilitate a sequence of research studies in a specific content area or multiple areas, and (2) a community of researchers and other stakeholders who reuse and develop those assets. Essential elements needed to develop the shared assets of a network include: network governance; trustworthy data and processes for sharing data; shared knowledge about research tools; administrative efficiency; physical infrastructure; and infrastructure funding. The community of researchers within a network is enhanced by: a clearly defined mission, vision and values; protection of human subjects; a culture of collaboration; and strong relationships with host organizations. While the importance of these elements varies based on the membership and goals of a network, this framework for sustainability can enhance strategic planning within the network and can guide relationships with external stakeholders.

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Cluster randomized trials to study the comparative effectiveness of therapeutics: stakeholders' concerns and recommendations

Cited by 13 publications

References 19 publications

Attitudes Toward Risk and Informed Consent for Research on Medical Practices

Attitudes Toward Risk and Informed Consent for Research on Medical Practices

The Use of Patient-reported Outcomes (PRO) Within Comparative Effectiveness Research

Sustaining Research Networks: the Twenty-Year Experience of the HMO Research Network

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