Translating stakeholder-driven comparative effectiveness research into practice: the PCORnet Bariatric Study

At the inception of PCORnet^®, the National Patient-Centered Clinical Research Network, the Patient-Centered Outcomes Research Institute (PCORI) invited each network to identify one stakeholder on a multidisciplinary Obesity Task Force, which was charged with identifying and prioritizing research topics that would both contribute important scientific knowledge related to obesity and demonstrate the utility of PCORnet for promoting evidence-based and patient-centered healthcare. One of the highest-priority topics was determined to be the comparison of safety and effectiveness of the most common bariatric procedures, and preliminary topic specification was undertaken by a work group including four patients, eight obesity medicine specialists, one bariatric surgeon and twelve researchers with expertise in topics related to obesity. Following a proposal development process that involved an expanded team of researchers and stakeholders from across PCORnet, PCORI went on to fund this research project as the PCORnet Bariatric Study (PBS) [17] using data from 41 health systems. PBS is the largest and longest multisite longitudinal cohort of bariatric patients ever assembled to examine weight loss, diabetes and safety outcomes, including 46,510 adults and 544 adolescents.

The PBS was guided by a 15-member Executive Stakeholder Advisory Group that included patients, advocacy group leaders, adult and pediatric surgeons, and obesity medicine providers who helped identify relevant outcomes, prioritize analyses, advise on study design and plan for dissemination of findings. Stakeholders attended the study’s in-person meetings and met twice monthly by teleconference over the course of the project. As the study evolved, stakeholders were also invited to work on smaller workgroups that were focused on research activities they were more passionate about.

The key research findings from PBS to date include statistically significant and clinically meaningful differences in all study end points across procedure groups. Specifically, at five years follow-up, the PBS found [17–20]: significantly greater percent total weight loss for RYGB (26%) than either SG (19%) or AGB (12%) [19]; similar cumulative incidence of diabetes remission for RYGB (86%) and SG (84%) – both significantly greater than AGB (59%); lower rates of diabetes relapse with RYGB (33%) compared with SG (42%) and AGB (73%) [21]; and finally, higher rates of abdominal operation or intervention with RYGB (12%) and AGB (41%) compared with SG (9%); as well as higher rates of hospitalization for AGB (42%), followed by RYGB (38%) and SG (33%) [20]. Figure 1 summarizes these results.

Only 1% of eligible patients choose to undergo bariatric surgery each year. Whether this is the ‘right rate’, based on the preferences of well-informed patients, is unknown, but a recent national survey of adults with severe obesity found that only 1 in 10 report that their primary care provider (PCP) had recommended bariatric surgery [22]. There is also a wide geographical variation in bariatric surgery use in the USA [17,23,24], and this variation in care is likely driven by a variety of factors, including, low patient understanding of the benefits and risks, lack of insurance coverage, and surgeon preference and skill (e.g., not all surgeons have been trained or feel comfortable with all procedures) [25]. For true shared decision making (SDM) to occur, it is important for surgeons to have a balanced discussion of the risks and benefits of all available options, not just the ones for which he or she has preference, expertise or special training. And PCPs should know how to identify appropriate bariatric surgical candidates, be broadly familiar with the available bariatric procedures and outcomes, and be able to engage patients in a SDM conversation that identifies their preferences for treatment [26].

Despite research demonstrating the effectiveness of SDM, uptake of SDM in clinical practice remains slow, and most clinicians and care settings have little or no experience with SDM [27]. Some of the systemic barriers to the use of SDM include perceived time constraints associated with SDM; perceptions that SDM does not work well with certain patient groups; lack of training to equip clinicians with requisite education and skills necessary to facilitate SDM; and the perception among providers that they already do SDM with their patients, despite evidence to the contrary [28]. In recognition of these challenges, PCORI requested applications for dissemination and implementation projects applying multicomponent implementation strategies to translate comparative effectiveness research into routine clinical practice through SDM [27], and the PBS team was awarded funding.

The primary objectives of our project are to refine, deploy and rigorously evaluate a multicomponent strategy to implement a SDM approach to improve decisions around bariatric surgery among patients with severe obesity in primary and specialty care settings. We have incorporated the comparative effectiveness research evidence from PBS into an existing decision aid (DA) and SDM approach, which has a demonstrated impact on patient knowledge, decisional conflict, satisfaction and care decisions [29–34]. The updated strategy will be implemented into two healthcare systems: Kaiser Permanente Washington (KPWA) and UPMC in Pennsylvania. These sites also contributed data to PBS, so their involvement in this phase of implementation work represent excellent examples of ‘learning health systems’ in action.

The EPIS – Exploration, Preparation, Implementation and Sustainment – conceptual model was used to guide our project design, implementation process, evaluation plan (e.g., timing and constructs of interest) and outcomes [35,36]. We are also using the Dynamic Adaptation Process to guide stakeholder-driven adaptations that are contextually responsive over time to inform our SDM approach for bariatric surgery in our healthcare systems (Figure 2) [35]. The process involves identifying the core elements and adaptable characteristics [37] of a SDM approach for bariatric surgery, then supporting SDM implementation in each health system with specific guidance on allowable adaptations that are planned and executed by a site-specific, multi-stakeholder Implementation Resource Team (IRT). The IRT members offer their expertise to prospectively identify multilevel factors of influence (system, organization, provider and consumer) that require implementation strategies, such as provider stigma related to obesity and obesity treatment that may act as a barrier to SDM. Additional implementation strategies will address known barriers to SDM from the published literature (Table 1) using approaches that have been successfully applied in our prior work [29–34].

The multi-disciplinary project team includes patients, bariatric surgeons, primary care physicians, implementation scientists and experts in shared decision making. There are three primary areas of stakeholder engagement: Development and refinement of the DA: patients, bariatric surgeons, PCPs, nurses, dieticians and psychologists were engaged in the development of the DA, and feedback from patients, bariatric surgeons, primary care physicians, clinical leaders from KPWA and UPMC, and professional society leaders informed the current version. The implementation plan for our SDM approach was also discussed with the PBS Executive Stakeholder Advisory Group. IRT: at each site, the IRTs include two patient members, as well as bariatric surgeons, bariatric medicine specialists, PCPs, quality leaders and administrators, nurse/care managers, administrators, DA developer, researchers and implementation scientists who drive barrier identification and prioritization and subsequent implementation strategy selection and deployment. Executive Stakeholder Advisory Group: modeled after the PBS project, an Executive Stakeholder Advisory Group comprising a diverse, national group of patients, surgeon leaders from the American Society of Metabolic and Bariatric Surgeons, primary care clinicians and leaders of the Obesity Action Coalition advises the IRT on the SDM approach and the revised DA, and will help interpret results.

The proposed SDM strategy will address two preference-sensitive decisions for patients with severe obesity: first, whether or not to undergo bariatric surgery and second, which bariatric procedure to undergo [25]. These preference-sensitive decisions require patients to consider important short- and long-term trade-off in risks and benefits as they decide between bariatric surgery or no surgery (e.g., risk of surgical complications vs long-term chance of weight loss), and the decision about which bariatric procedure to undergo is driven both by patient preferences and other factors (e.g., surgeon preferences, insurance coverage) [38].

Consistent with our prior SDM implementation work at KPWA involving more than a dozen preference-sensitive decisions in six specialty areas (orthopedics, gynecology, urology, neurosurgery, general surgery and cardiology; >50,000 DAs delivered since 2009; >4000 DAs annually) [31–34], the proposed SDM approach has four core components: first, identification of eligible patients, second, delivery of an evidence-based patient DA, third, a structured SDM conversation and fourth, documentation of the SDM conversation in the electronic medical record. Briefly, patients with severe obesity who are eligible for SDM will be identified by their PCPs (or other clinic staff such as medical assistants or nurses) during routine visits or at the point of referral to the bariatric surgeon. Eligible patients will receive the DA, which will be ordered through the electronic medical record at both sites and delivered as a hard copy DVD (with booklet) or viewed online. Patients will be asked to review the DA prior to their next visit, at which the provider will engage the patient in a SDM conversation and document the SDM conversation in the medical record. PCPs conversations will focus primarily on whether the patient is interested enough in bariatric surgery to be referred to the surgeon. The surgical SDM conversations will address whether to have surgery, and if so, which procedure to undergo.

We expect that the implementation of the PBS results and our SDM approach will improve healthcare and outcomes primarily through higher quality decision making. Specifically, patients with severe obesity will report that their providers helped them better understand their options including the risks and benefits, inquired about their preferences, and took their preferences into account when choosing what to do next. Providers will also be more knowledgeable about the available options, feel more confident in their ability to discuss these options with patients, and feel more confident in their patients’ decisions. In terms of decision making, we expect to learn whether the improved dissemination of evidence about the efficacy and safety of bariatric surgery results in changes in the rate of referral to bariatric surgery and the rate of uptake of bariatric surgery among eligible patients (which is currently ∼1% of eligible patients). We expect referrals to bariatric surgery programs and volume of surgery may increase; however, the expected magnitude of the increase is unclear and will be driven by informed patient preferences.

Central to the PBS results, which compare the effectiveness and safety of bariatric procedures, we also expect to learn whether this SDM approach influences decision making about the type of bariatric procedure patients choose to undergo. Currently, many patients in our health systems choose the SG procedure; however, the PBS evidence for the SG is mixed, showing better safety, but less weight loss and less durable improvements in diabetes compared with RYGB. It is unclear whether the proportion of patients choosing SG, RYGB and AGB will change with improved SDM, but our study is well-positioned to track any shifts in procedure choice.

We believe that this SDM approach will be broadly generalizable and scalable for use in other settings. Our stakeholder engagement strategy will also help to ensure that other major professional groups and healthcare organizations can disseminate this SDM approach. It is our hope that implementation of this SDM approach will help to more rapidly translate comparative effectiveness research into clinical practice and improve the quality of decision making around bariatric surgery.

The views, statements and opinions presented in this editorial are solely the responsibility of the author(s) and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute^® (PCORI^®), its Board of Governors or Methodology Committee.

Research reported in this editorial was funded through two Patient-Centered Outcomes Research Institute^® (PCORI^®) Awards (SDM-2018C2-13368 and OBS-1505-30683). A Courcoulas reported receiving grants from Allurion Technologies outside the submitted work. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.