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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.)
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].
Show detailsRecently Published and Ongoing Studies
The findings from our review of the recently published literature and ongoing studies are summarized in Appendix C.
The PubMed search updating the original CER identified 309 articles. These were reviewed, and 25 met our inclusion criteria. The majority of large studies reporting cardiovascular outcomes reported secondary outcomes or subgroup analyses from previously published large clinical trials.12,16–19 There was no recently published research for several of the research areas, including strategies to enhance greater evidence-based use, impact of ACE inhibitors or ARBs on quality of life, impact of ACE inhibitor/ARB adherence, and dose-response relationship between ACE inhibitors and ARBs. The largest number of recently published research focused on the outcomes of cardiovascular events (10 studies) and development of new diagnoses (6 studies). One large clinical trial published after the CER report found no impact of the ARB valsartan vs. placebo on cardiovascular outcomes.20
The search of Clinicaltrials.gov identified 207 registered trials, of which 60 were still open at the time of the search. From these, we included 25 studies based on our review criteria.
The search of PubMed for relevant systematic reviews identified 134 articles, of which only 3 were included after review. The majority of articles were excluded because they represented expert narrative reviews rather than systematic reviews to answer a particular research question.
Recommended Research Prioritization
We describe here the findings of our three prioritization exercises. As described above, prioritization was designed as an iterative process with each successive exercise built on the previous exercise and its findings. Each step was followed by a conference call, during which stakeholders were provided with the prioritization results and had an opportunity to discuss the findings and the relative merits of each research priority. This process occurred in three distinct steps:
- After compiling the list of potential future research areas, stakeholders were asked to:
- Rate the importance of each research area using a 5-point Likert scale
- Rank their top five priority research areas
- Following review and discussion of these initial results, we asked individual stakeholders to rank all 16 research areas in order of importance.
- We provided the stakeholders with an updated literature review of recent and ongoing research for each priority and presented a decision analytic model identifying areas of uncertainty in this field. Following this, we asked each stakeholder to re-rank all 16 research areas in order of importance.
Prioritization Exercise 1
Table D1 (Appendix D) provides the Likert scale data for the first step in the research prioritization. Of note, this method of prioritization did not allow the 16 research areas to be broadly distributed in terms of importance and resulted in numerous areas receiving the same average score. Table D2 (Appendix D) lists the research areas grouped by average score.
Table D3 (Appendix D) demonstrates the results when stakeholders were asked to explicitly rank the top five research areas. Table D4 (Appendix D) summarizes these findings and when compared with Table D2 (Appendix D) demonstrates that the prioritization of these research areas differs depending on the prioritization method used.
Prioritization Exercise 2
Our second prioritization exercise had individual stakeholders rank the 16 research areas in order of importance. Table D5 (Appendix D) provides the results of this ranking by stakeholder and then summary statistics of these rankings. Of note is that 14 of 16 research areas were ranked by at least one stakeholder as being in the top four research areas, while simultaneously being ranked by a second stakeholder as being in the bottom four research areas in terms of importance. Five of the research priorities (evidence-based use, comorbidities, adherence, cardiovascular outcomes, and class effect) were ranked by at least one stakeholder as being most important area for future research.
Table D6 (Appendix D) displays the prioritized list of research areas using the average rank score. The overall ranking of the list did not differ substantially when it was prioritized using the median score. Prioritizing based on the 1st quartile would have increased the importance of evaluating ACE inhibitor/ARB adherence (from a rank of 6th to 2nd).
Prioritization Exercise 3
Our final prioritization exercise had stakeholders re-rank the research areas from 1 to 16 after reviewing the findings of the decision analytic model, discussing as a group the rankings from the second prioritization exercise, and reviewing the status of recently published and ongoing studies by research area (see Appendix C).
Table D7 (Appendix D) presents the individual rankings and summary statistics for this final prioritization exercise. Of note, most of the rankings remained consistent between the second and third exercises. Notable exceptions included the ranking of research into the incidence of new diagnoses (such as diabetes, atrial fibrillation, or CHF with or without preserved LV function), which fell from being ranked second to being ranked sixth. It was instead replaced by an emphasis on research into medication adherence. This change could potentially have been influenced by the relatively large number of recently published studied (n=6) and ongoing clinical trials (n=5) related to new diagnoses and the scarcity of research (no new studies, and one potentially relevant clinical trial) related to medication adherence. Of interest, the decision analytic model of ACE inhibitor and ARB therapy in IHD patients indicated that uncertainty related to new diagnoses had a significant impact on the model’s findings.
Although the overall ranking did not change substantially from the second to the third prioritization exercise, the consensus among the stakeholders in their rankings did improve. The variance in the rankings was greatly reduced, and although one stakeholder still ranked the top research area (evidence-based use) as 12th, there was much more consistency among the stakeholders and their rankings of the top and bottom five areas.
Table 2 lists the final prioritization of the 16 research areas using the average score from Prioritization Exercise 3. Gray shading indicates gaps identified by the stakeholders that were not part of the scope of the original CER.
Table 2
Final ranking of 16 research areas.
Appropriate and Feasible Study Designs
Table 3 depicts our final ranked research areas and specific recommendations for addressing the 16 identified evidence gaps. For each potential research area, we provide our rationale for why each higher level of study design is not feasible or appropriate. The top six research areas were consistently ranked highly and deemed most important; these six areas are enclosed within broad borders for emphasis in Table 3. Again, those research areas that were outside the scope of the original CER are shaded in gray. While these gaps were clearly identified as important by the stakeholders, we have some caveats concerning recommended study designs. We did perform a literature search and a search of ongoing trials to identify duplication and assess feasibility; however our choice of study design is less well grounded for these gaps than for the other gaps which are backed up by a full systematic review
Table 3
Ranked research area prioritization and recommended study designs for addressing evidence gaps.
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