Stakeholder Engagement in Pragmatic Clinical Trials: Emphasizing Relationships to Improve Pain Management Delivery and Outcomes.

BACKGROUND: The NIH-DOD-VA Pain Management Collaboratory (PMC) supports 11 pragmatic clinical trials (PCTs) on nonpharmacological approaches to management of pain and co-occurring conditions in U.S. military and veteran health organizations. The Stakeholder Engagement Work Group is supported by a separately funded Coordinating Center and was formed with the goal of developing respectful and productive partnerships that will maximize the ability to generate trustworthy, internally valid findings directly relevant to veterans and military service members with pain, front-line primary care clinicians and health care teams, and health system leaders. The Stakeholder Engagement Work Group provides a forum to promote success of the PCTs in which principal investigators and/or their designees discuss various stakeholder engagement strategies, address challenges, and share experiences. Herein, we communicate features of meaningful stakeholder engagement in the design and implementation of pain management pragmatic trials, across the PMC. DESIGN: Our collective experiences suggest that an optimal stakeholder-engaged research project involves understanding the following: i) Who are research stakeholders in PMC trials? ii) How do investigators ensure that stakeholders represent the interests of a study's target treatment population, including individuals from underrepresented groups?, and iii) How can sustained stakeholder relationships help overcome implementation challenges over the course of a PCT? SUMMARY: Our experiences outline the role of stakeholders in pain research and may inform future pragmatic trial researchers regarding methods to engage stakeholders effectively.

Consideration of substance use in compensation and pension examinations of veterans filing PTSD claims.

Veterans filing claims that service-induced PTSD impairs them worry that claims examiners may attribute their difficulties to conditions other than PTSD, such as substance use. Substance use commonly co-occurs with PTSD and complicates establishing a PTSD diagnosis because symptoms may be explained by PTSD alone, PTSD-induced substance use, or by a substance use condition independent of PTSD. These alternative explanations of symptoms lead to different conclusions about whether a PTSD diagnosis can be made. How substance use impacts an examiner's diagnosis of PTSD in a Veteran's service-connection claim has not been previously studied. In this study, we tested the hypothesis that mention of risky substance use in the Compensation & Pension (C&P) examination would result in a lower likelihood of service-connection award, presumably because substance use reflected an alternative explanation for symptoms. Data were analyzed from 208 Veterans' C&P examinations, medical records, and confidentially-collected research assessments. In this sample, 165/208 (79%) Veterans' claims were approved for a mental health condition; 70/83 (84%) with risky substance use mentioned and 95/125 (76%) without risky use mentioned (p = .02). Contrary to the a priori hypothesis, Veterans with risky substance use were more likely to get a service-connection award, even after controlling for baseline PTSD severity and other potential confounds. They had almost twice the odds of receiving any mental health award and 2.4 times greater odds of receiving an award for PTSD specifically. These data contradict assertions of bias against Veterans with risky substance use when their claims are reviewed. The data are more consistent with substance use often being judged as a symptom of PTSD. The more liberal granting of awards is consistent with literature concerning comorbid PTSD and substance use, and with claims procedures that make it more likely that substance use will be attributed to trauma exposure than to other causes.