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Ehlers AP, Davidson GH, Bizzell BJ, et al. Engaging Stakeholders in Surgical Research: The Design of a Pragmatic Clinical Trial to Study Management of Acute Appendicitis. JAMA Surg. 2016;151(6):580–582. doi:10.1001/jamasurg.2015.5531
Evidence from randomized clinical trials in Europe within the past 20 years suggests that antibiotics alone may be used to treat acute appendicitis as an alternative to appendectomy, the standard of care for more than 100 years.1 Despite this, there are concerns about long-term outcomes, especially with regards to quality of life and safety.2 To answer these questions, we designed a pragmatic clinical trial to be conducted in the United States. Engaging health care stakeholders provided an opportunity to assess feasibility of study conduct, identify barriers to implementation, and determine relevant outcomes to inform decision making and translation of evidence to practice. Very little has been written about stakeholder engagement in the context of surgical research,3 especially in the setting of acute conditions. We describe our approach for the development of a stakeholder-informed research proposal to apprise the surgical community on how such a strategy can be used.
The Comparative Effectiveness Research Translation Network, based in Washington State, is aligned with the Surgical Care and Outcomes Assessment Program,4,5 a quality improvement and benchmarking collaborative. We engaged patients and clinicians during the development and design of a large pragmatic clinical trial in response to the Patient-Centered Outcomes Research Institute call for proposals. The Comparative Effectiveness Research Translation Network patient stakeholders worked directly with the research team throughout the design phase, and a broader public network was approached to provide general feedback about the study through blogs, social media, crowdsourcing, and direct physician outreach. A survey of surgeons from the Association of Surgeons of Great Britain and Ireland informed how the use of antibiotics is changing because the evidence generated to date stems from European experience. Fifteen clinician advisors within the Surgical Care and Outcomes Assessment Program network engaged directly with the study team and conducted outreach at their respective hospitals to patients, clinicians, staff, and administrative personnel.
We engaged 834 potential patients between November 2014 and December 2014 through the combination of approaches described. Nearly half (47%) indicated that they would participate in a future study and stated willingness to be randomized. Participants provided subjective information about their specific concerns with the study (Figure). This information helped determine sample size, develop patient educational materials, and establish meaningful outcomes for the study. One hundred ninety-six surgeons responded to the Association of Surgeons of Great Britain and Ireland survey; 20% stated that within the last year they had offered antibiotics to patients with appendicitis. Ten hospitals with 81 surgeons in the Comparative Effectiveness Research Translation Network network agreed to allow their patients to be approached for recruitment, to adhere to the study protocol, and to address barriers to the study. Feedback from 15 clinician advisors led to important changes to study exclusion criteria, study logistics, and criteria for failure of the antibiotics strategy. Patient and clinician partners advised study design outcomes which would help inform treatment decisions of future patients (Table).
We described 1 strategy for stakeholder engagement using novel approaches for development of a research proposal. The next step is defining measures to judge the success of this work. Standards should address the success of participant recruitment and enrollment; judge the appropriateness of the outcomes; and evaluate dissemination of results. A more immediate measure of success may be the award of funds to carry out the study because demonstration of meaningful engagement is a core aspect of funding. This work was part of a successful application for the Comparing Outcomes of Drugs and Appendectomy study, a pragmatic clinical trial funded by Patient Centered Outcomes Research Institute.6 Patient engagement is increasingly important in surgical research, and we encourage others to share their strategies. Just as dissemination of clinical findings leads to improvements in outcomes, dissemination of engagement strategies may increase the success of future studies.
Corresponding Author: Anne P. Ehlers, MD, Division of General Surgery, Department of Surgery, University of Washington, 1107 NE 45th St, PO Box 354808, Ste 502, Seattle, WA 98195 (email@example.com).
Published Online: February 24, 2016. doi:10.1001/jamasurg.2015.5531.
Author Contributions: Dr Ehlers had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Ehlers, Bizzell, Guiden, Skopin, Lavallee.
Acquisition, analysis, or interpretation of data: Ehlers, Davidson, Bizzell, Skopin, Flum, Lavallee.
Drafting of the manuscript: Ehlers, Davidson, Skopin, Flum.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Ehlers, Flum.
Obtained funding: Flum.
Administrative, technical, or material support: Ehlers, Davidson, Guiden, Skopin, Flum.
Study supervision: Davidson, Lavallee.
Conflict of Interest Disclosures: None reported.
Funding/Support: Dr Ehlers was supported by a training grant from the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health under award T32DK070555. This foundational research served as the basis for the Comparing Outcomes of Drugs and Appendectomy Trial, a contract recently awarded from Patient-Centered Outcomes Research Institute.
Role of the Funder/Sponsor: The National Institutes of Health did not participate in design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Additional Contributions: We thank Kathleen O’Connor for serving as a patient partner during this work, as well as Rebekka Herr and Sarah Lawrence at the Comparative Effectiveness Research Translation Network for their work on the patient engagement campaign. Mss Herr and Lawrence were compensated for their work.