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Sanders GD, Powers B, Crowley M, et al. Future Research Needs for Angiotensin Converting Enzyme Inhibitors or Angiotensin II Receptor Blockers Added to Standard Medical Therapy for Treating Stable Ischemic Heart Disease: Identification of Future Research Needs from Comparative Effectiveness Review No. 18 [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2010 Nov. (Future Research Needs Papers, No. 8.)

Cover of Future Research Needs for Angiotensin Converting Enzyme Inhibitors or Angiotensin II Receptor Blockers Added to Standard Medical Therapy for Treating Stable Ischemic Heart Disease

Future Research Needs for Angiotensin Converting Enzyme Inhibitors or Angiotensin II Receptor Blockers Added to Standard Medical Therapy for Treating Stable Ischemic Heart Disease: Identification of Future Research Needs from Comparative Effectiveness Review No. 18 [Internet].

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In addition to prioritizing future research areas specific to ACE inhibitor and ARB therapy in patients with IHD, this pilot study provided several insights into the future research needs assessment process within the broader EPC program. The following discussion points and recommendations are based both on the experience of the investigative team and on explicit feedback received from the stakeholder group.

The discussions with stakeholders and research prioritization revealed two distinct perspectives on future research priorities. All stakeholders agreed that the extensive body of literature evaluating ACE inhibitors and ARBs in patients with or at high risk for IHD had definitively answered many of the key questions posed in the CER on a large population level; however, they viewed the subsequent priorities differently. The first perspective placed the highest value on understanding heterogeneity of treatment effects so that therapy could move from being based on broad population categories (i.e., patients with IHD) to a more individually tailored approach. From this perspective, understanding differential treatment effects according to baseline demographics, comorbidities, genetics, or concurrent medications represents a logical step toward a more personalized approach to treatment. This perspective is shared by many, and a substantial amount of research in several areas is focused on extending evidence-based medicine to personalized medicine.

The second perspective acknowledges that while traditional research on clinical efficacy or harms may be worthwhile, its value would be small relative to focusing on improving the application of this research to high-risk populations who are likely to benefit from these medications. This perspective recognizes the suboptimal quality of care and unexplained treatment variations and seeks to improve the broader implementation of ACE inhibitors and ARBs to the population likely to benefit. From this health services perspective, stakeholders would place particular value on research to improve evidence-based use, treatment adherence, and cost and utilization of therapy.

The importance of improved evidence-based use of these therapies was specifically highlighted by several members of the stakeholder group in the first conference call. The emphasis on this point could be interpreted two ways. It could be understood as a prioritization of dissemination and implementation of the current research findings which were felt to have answered the key questions with sufficient precision. This interpretation views the value of advancing current knowledge about ACE inhibitors or ARBs as significantly lower than the value of maximizing the fidelity with which current knowledge is implemented; however, it may not necessarily specify the methods by which this is achieved. To some this may be considered a vote against continued research on the comparative effectiveness of ACE inhibitors or ARBs. However, prioritizing greater evidence-based use could alternatively be viewed as a vote for greater funding of the science of implementation. This may include interventions such as prescriber decision support, financial incentives, or other means to promote evidence-based use of ACE inhibitors or ARBs. While we tried to distinguish gaps in implementation from gaps in implementation science with the stakeholder group, we cannot be certain which is most represented in our current prioritization. This issue would be worth exploring in future research prioritization, especially as it is not unique to our content area.

There were likely other underlying perspectives; these were not explicitly discussed during the prioritization process, but became more apparent as the stakeholder discussion unfolded. An explicit discussion of broader viewpoints may have provided greater transparency for the perspective reflected in this prioritization.

In terms of the prioritization methods used, the investigative team and stakeholder group had several recommendations. Overall, our experience suggests that the results of stakeholder prioritization exercises performed cold (that is, without provision of basic information about the status of current research, etc.), are likely to be unstable and may vary greatly depending on what instrument is used. However, provision and discussion of such data appear to lead to greater consensus and more stable ranking of stakeholder preferences. Specifically, we make the following recommendations:

  • The EPC’s review of the recently published literature and ongoing studies was performed and shared with stakeholders between Prioritization Exercises 2 and 3. It was widely agreed by stakeholders that this information was very helpful in their understanding of the evidence gaps and importance of future research. We therefore suggest that this step be performed before engagement of the stakeholder group so that results can be shared with them early in the process. Note that depending on when the Future Research Needs report is developed in the CER process, this information may come directly from the CER and therefore not require an additional step
  • Several of the stakeholders felt that they had expertise in related fields (cardiovascular trials, medical decisionmaking, patient advocacy) but were not particularly well-qualified in the specific domain of ACE inhibitor and ARB therapy in IHD. Although the breadth of expertise and perspectives in the stakeholder group was intentional, it would have been helpful to the group for the EPC team to provide additional background material and time for the stakeholder group to become familiar with the existing evidence and specific clinical domain. Again, developing the Future Research Needs report as part of the CER process would allow the evidence report to serve as the source of this background material.
  • A face-to-face meeting was suggested by both stakeholders and the investigative team. Although such a meeting would have required both time and resources, it would have allowed a more global presentation of the available evidence, the decision analytic model, and, most importantly, an opportunity for the stakeholders to discuss amongst themselves (with the guidance of the EPC team) the reasons for their specific rankings.
  • The optimal size of the stakeholder group is unclear. In addition to considerations regarding appropriate representation of all potential stakeholders, the time and resources available for meetings and conference calls, and establishing processes to ensure that all stakeholders have the opportunity to contribute, there are sample size issues raised by using methods such as mean ranking scores—a larger number of rankings might have allowed a greater spread of scores, or sufficient variation in the distribution of scores, to assist in discriminating between different research areas.
  • Because the pilot projects were, by necessity, both exploring potential prioritization methods and a specific clinical domain, it is unclear whether specific tools or processes were challenging because of their methodology or because of the specific evidence base (or lack thereof) for the clinical domain. It will therefore be important to look across the entire set of pilot projects for broad themes that can be incorporated into the global EPC program.

Note that we did not explicitly engage our stakeholder group in two components of our study, namely, (1) determination of recommended study design for the identified research areas, and (2) a discussion of the criteria by which the research areas should be ranked. Although both of these steps are important components of ranking future research priorities, the time and interaction available with the stakeholder group was limited. In future prioritization exercises, engagement of the stakeholders in these steps is encouraged.

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