Identification of outcomes in clinical studies of interventions for venous thromboembolism in non-pregnant adults: A scoping review.

Tritschler, Tobias; Cusano, Ellen; Langlois, Nicole; Mathieu, Marie-Eve; Hutton, Brian; Shea, Beverley J; Shorr, Risa; Skeith, Leslie; Duffett, Lisa; Cowley, Lindsay; Ng, Sara; Dubois, Suzanne; West, Carol; Tugwell, Peter; Le Gal, Grégoire (2022). Identification of outcomes in clinical studies of interventions for venous thromboembolism in non-pregnant adults: A scoping review. Journal of thrombosis and haemostasis, 20(10), pp. 2313-2322. Wiley-Blackwell 10.1111/jth.15787

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INTRODUCTION

The development of a core outcome set (COS), defined as an agreed minimum set of outcome domains that should be measured and reported in all trials of a specific disease, aims to increase the relevance of study findings to stakeholder groups and improve standardization.

OBJECTIVES

As the first step in developing a COS for venous thromboembolism (VTE) treatment studies, we aimed to generate an inclusive list of unique outcomes reported in previous VTE treatment studies and classify them into domains and core areas.

METHODS

MEDLINE, Embase and CENTRAL were searched for prospective studies reporting on interventions for VTE in non-pregnant adults. Study selection and data extraction were performed in blocks based on publication date, starting with 2015-2020 and subsequent 1-year periods, until no new outcome was identified. Outcomes were classified into domains, which are groups of closely related outcomes, and domains into four core areas including death, pathophysiological manifestations/abnormalities, life impact, and resource use.

RESULTS

Of 7100 records identified, we included 240 publications, representing 165 distinct studies. We identified 205 unique outcomes that were grouped into 48 domains. A total of 30 (13%) studies covered ≥3 core areas; death was included in 102 (43%), pathophysiological manifestations/abnormalities in 218 (91%), life impact in 41 (17%), and resource use in 25 (10%) studies.

CONCLUSION

Most VTE treatment studies evaluated pathophysiological features of VTE, but few studies reported outcomes that measured life impact or resource use. Our findings will inform next steps in the development of a COS for VTE treatment studies.

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