Tag Archives: Comparative effectiveness research

New article compares different approaches for notification and authorization in pragmatic clinical research

Comparative Effectiveness Research, Informed Consent, Notification and Authorization, Pragmatic clinical trials, Regulatory issues, , , , , ,

Dr. Kevin Weinfurt and colleagues in the Regulatory/Ethics Core of the NIH Collaboratory recently published an article in the American Journal of Bioethics regarding how acceptable different approaches to notification and authorization are to potential participants in pragmatic research. The authors conducted a series of interviews using 24 different hypothetical scenarios reflecting different types of studies and approaches to notification and authorization.

Key findings:

  • People have significant difficulty understanding 1) randomization and 2) that all the data are collected during routine care, and no extra visits or tests are required.
  • For some types of pragmatic research, many of the respondents viewed
    • Active alternatives to written consent—such as oral consent—as acceptable.
    • Less active approaches to notification—such as no notification ahead of time or broad notification—as unacceptable.
  • When using written consent in cases where researchers are testing accepted medical interventions that have known clinical risks but with no incremental risks of participating in the research, it was acceptable to omit the clinical risks from the consent documents, thereby shortening the forms.
  • A significant portion (28-49%) of respondents would decline to participate regardless of notification approach, which could lead to non-trivial consent bias (in other words, there could be significant differences in people who decline vs people who agree to participate).

Based on these findings, the authors suggest alternate approaches to notification and authorization should be further developed and tested.

Read the full article here.

PCORnet Posts Aspirin Study Protocol for Public Review and Comment

Clinical trials, Comparative Effectiveness Research, Electronic health records, Patient-Centered Outcomes Research, Pragmatic clinical trials, Randomized controlled trials, , , , , , , , ,

PCORnetThe National Patient-Centered Clinical Research Network (PCORnet) has recently made a draft protocol for its first randomized clinical trial available for stakeholder review. Researchers, clinicians, patients and the public are all invited to read the current draft of the study protocol and provide comments and feedback.

The ADAPTABLE Study (PDF), which will investigate whether lower- or higher-dose aspirin is better for preventing heart attack and stroke in patients at risk for heart disease, is PCORnet’s first randomized pragmatic clinical trial. Designed to leverage PCORnet’s Clinical Data Research Networks (CDRNs) and Patient-Powered Research Networks (PPRNs), the trial will serve as twofold purpose: answering a clinical question of direct importance for patients, families, and healthcare providers, and serving as a demonstration of PCORnet’s capabilities in conducting clinical research on a national scale.

Links to the proposed study protocol, a survey tool for capturing feedback, and other information about ADAPTABLE Study, including press releases, fact sheets, and infographics, are available at the link below:

ADAPTABLE: The Aspirin Study

Follow PCORnet on Twitter @PCORnetwork for updates on the ADAPTABLE #ClinicalTrial

Patient-Reported Outcomes Workshop Report Available

Clinical outcomes, Clinical trials, Comparative Effectiveness Research, Patient-Centered Outcomes Research, Patient-Reported Outcomes, Pragmatic clinical trials, Research tools, , , , , , , , , ,

Tools for ResearchIn January of 2015, the NIH HCS Collaboratory’s Patient-Reported Outcomes (PRO) Core Group convened a 2-day workshop in Baltimore devoted to identifying barriers and possible solutions to the use of NIH-supported PRO tools in comparative-effectiveness research (CER).

Findings from the meeting, which include case study presentations and reflections from multiple stakeholders representing the research, clinical, and patient communities, were distilled into a summary document available from the NIH Collaboratory Knowledge Repository at the link below:

The workshop summary is also available on the Living Textbook’s “Tools for Research” section, under “Patient-Reported Outcomes White Paper.”

Systematic Review on Stakeholder Engagement in Comparative Effectiveness and Patient-Centered Outcomes Research

Comparative Effectiveness Research, Patient-Centered Outcomes Research, , , ,

This month’s issue of the Journal of General Internal Medicine features a systematic review of stakeholder engagement in comparative effectiveness research and patient-centered outcomes research. Thomas W. Concannon, PhD, and coauthors identified 70 peer-reviewed articles since 2003 that reported on this topic.

Key results included:

  • Patients were the most commonly engaged group, followed by modest engagement of clinicians, and infrequent engagement of other stakeholders across the healthcare system.
  • Stakeholders were more often engaged in earlier stages of research (evidence prioritization and generation) than in later activities such as evidence interpretation and application.

Overall, reporting of stakeholder activities and the effects of engagement were highly variable in the literature. To address this, the authors developed a 7-item questionnaire for the reporting of stakeholder engagement in research. A suggested plan for future research on stakeholder engagement is also outlined.