Core outcome set for clinical trials of stent implantation in coronary heart disease -- a systematic review and mixed-method consensus study

Background

Although various types of stent interventions have been found in clinical trials to be effective in treating coronary heart disease, researchers often use heterogeneous outcome measures. This can preclude the comparison of results across studies and prevent effective meta-analyses from answering important clinical questions. The need to standardize outcome measure reporting is urgent. This study aims to produce a core outcome set(COS) for coronary stent implantation research.

Methods

We performed a systematic review via the PubMed and EMBASE databases and then synthesized recommendations from international standardized endpoint definitions and consensus documents to generate a list of potential outcomes. We conducted a two-round Delphi survey, achieving the iterative selection of potential outcomes. A multidisciplinary panel of experts and patients with coronary stent implantation experience rated the importance of candidate outcomes on a 9-point Likert scale. To be provisionally accepted, outcomes needed to be critical important (score 7-9, with 9 being the maximum) by 70% of each stakeholder group. Finally, we held a consensus meeting to discuss and generate the COS.

Results

A total of seventy-two potential outcomes were identified by systematic literature review. We obtained nine key consensus documents to inform the standardized definitions of the outcomes. After duplication and combination of similar outcomes, 26 of the 72 outcomes assigned into five outcome domains were included in the Delphi surveys. Twenty outcomes were provisionally accepted. Following the consensus meetings, the agreement was reached on a twelve-item COS.

Conclusion

We developed a COS for coronary stent implantation in coronary heart disease. Its implementation will facilitate the standardization reporting of clinical trials and reduce the heterogeneity in assessment in future research. Further research may help determine the specific, validated measurement instruments to assess each outcome.

What is Known

• Coronary stent implantation is consider to be the primary method for treating coronary heart disease.

• Many trials use heterogeneous effectiveness and safety outcome measures with different defined and non-patient concerned outcome measures, which would largely prevent meta-analyses and contribute to selective reporting bias.

What the Study Adds

• We initially develop the first core outcome set(COS) of coronary stent implantation intervention for China to facilitate the standardization reporting of clinical trials and enable meta-analysis.

• In our study, patient concerned outcome measure were thoroughly discussed and included in the COS by extensively involved patient representatives in every step of the project.

• Although we used rigorous method to development the COS, it should be updated as new evidence emerges in this rapidly evolving field.