We conducted a review of the peer-reviewed literature since 2003 to catalogue reported methods of stakeholder engagement in comparative effectiveness research and patient-centered outcomes research. We worked with stakeholders before, during and after the review was conducted to: define the primary and key research questions; conduct the literature search; screen titles, abstracts and articles; abstract data from the articles; and analyze the data. The literature search yielded 2,062 abstracts. The review was conducted on 70 articles that reported on stakeholder engagement in individual research projects or programs. Reports of stakeholder engagement are highly variable in content and quality. We found frequent engagement with patients, modestly frequent engagement with clinicians, and infrequent engagement with stakeholders in other key decision-making groups across the healthcare system. Stakeholder engagement was more common in earlier (prioritization) than in later (implementation and dissemination) stages of research. The roles and activities of stakeholders were highly variable across research and program reports. To improve on the quality and content of reporting, we developed a 7-Item Stakeholder Engagement Reporting Questionnaire. We recommend three directions for future research: 1) descriptive research on stakeholder-engagement in research; 2) evaluative research on the impact of stakeholder engagement on the relevance, transparency and adoption of research; and 3) development and validation of tools that can be used to support stakeholder engagement in future work.

Background—: Evidence suggests that recent and projected future investments in percutaneous coronary intervention (PCI) programs at US hospitals fail to increase access to timely reperfusion for patients with ST-segment elevation myocardial infarction. Methods and Results—: We set out to estimate the annual number and costs of new PCI programs in US hospitals from 2004 to 2008 and identify the characteristics of hospitals, neighborhoods, and states where new PCI programs have been introduced. We estimated a discrete-time hazard model to measure the influence of these characteristics on the decision of a hospital to introduce a new PCI program. In 2008, 1739 US hospitals were capable of performing PCI, a relative increase of 16.5% (251 hospitals) over 2004. The percentage of the US population with projected access to timely PCI grew by 1.8%. New PCI programs were more likely to be introduced in areas that already had a PCI program with more competition for market share, near populations with higher rates of private insurance, in states that had weak or no regulation of new cardiac catheterization laboratories, and in wealthier and larger hospitals. Conclusions—: Our data show that new PCI programs were systematically duplicative of existing programs and did not help patients gain access to timely PCI. The total cost of recent US investments in new PCI programs is large and of questionable value for patients.

An important challenge in comparative effectiveness research is the lack of infrastructure to support pragmatic clinical trials, which compare interventions in usual practice settings and subjects. These trials present challenges that differ from those of classical efficacy trials, which are conducted under ideal circumstances, in patients selected for their suitability, and with highly controlled protocols. In 2012, we launched a 1‐year learning network to identify high‐priority pragmatic clinical trials and to deploy research infrastructure through the NIH Clinical and Translational Science Awards Consortium that could be used to launch and sustain them. The network and infrastructure were initiated as a learning ground and shared resource for investigators and communities interested in developing pragmatic clinical trials. We followed a three‐stage process of developing the network, prioritizing proposed trials, and implementing learning exercises that culminated in a 1‐day network meeting at the end of the year. The year‐long project resulted in five recommendations related to developing the network, enhancing community engagement, addressing regulatory challenges, advancing information technology, and developing research methods. The recommendations can be implemented within 24 months and are designed to lead toward a sustained national infrastructure for pragmatic trials.

We believe it can; now we should put it to the test The Patient-Centered Outcomes Research Trust Fund (PCORTF) was established in 2009 to support research that is funded, designed, carried out, and put into practice within a culture of patient centeredness.1 A legislatively mandated review in 2017 of the “adequacy and use of funding” will be used to determine whether PCORTF funding levels should be continued or adjusted after its authorization runs out in autumn 2019. As 2017 approaches, researchers ought to begin taking stock of our work in patient centered outcomes research: how well are we are doing and what might we do better? In the linked paper (doi:10.1136/bmj.h3786), Xian and colleagues present a solid example of how to refocus research on questions, outcomes, and approaches that could help patients and clinicians to make better healthcare decisions. The team studied prescribing of warfarin for patients with ischemic stroke who were discharged from hospital between 2009 and 2011 with persistent or paroxysmal atrial fibrillation or flutter.2 This study was funded by the Patient-Centered Outcomes Research Institute (PCORI) in 2013. This team’s preliminary work with patients resulted in prioritization …

Aim: Research regarding decisions patients make about total knee arthroplasty, apart from having the procedure or not, are limited. Understanding patient decision making and related information needs is essential for shared decision making. Methods: Focus groups with an online community-based sample identified decisions about total knee arthroplasty beyond the decision to have the surgery itself. An online survey was used to determine relative importance of five major decisions and evaluate related information available. Results: Patients did not feel they have enough information to make important decisions of surgeon, device type, surgical approach, facility, or timing, for their total knee arthroplasty. Conclusion: Although further research is needed to generalize these findings, physicians should consider these questions during shared decision making with patients considering total knee arthroplasty.