Research and practice in thrombosis and haemostasis · 2026
Variation in outcome reporting in studies on the prevention and management of pregnancy-associated venous thromboembolism: a scoping review.
СтатьяScoping ReviewНазвание и аннотация: Перевод в очереди
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King Alexandria, D'Souza Rohan, Herman Dylan, Shehata Nadine, Malinowski A Kinga
Аннотация
BACKGROUND: Pregnancy-associated venous thromboembolism (pVTE) is a notable cause of maternal morbidity and mortality. Yet, robust comparisons across studies are hampered by inconsistencies in outcome reporting.
OBJECTIVES: This study determined the state of outcome reporting in studies addressing prevention and management of pVTE.
METHODS: In this scoping review, we searched 7 databases including Medline, Embase, the Cochrane databases and 3 international trial registries. Clinical trials, registrations, and observational studies (prospective and retrospective) focusing on prevention or management of pVTE, published in English between 1998 and November 2018, were included. We recorded study characteristics, reported outcomes and their definitions, and categorized outcomes in accordance with a published taxonomy for outcomes in medical research. We conducted descriptive analysis to demonstrate variation in reporting and definition of outcomes and the representation of outcomes by categories in the taxonomy.
RESULTS: Of 7541 results, 70 studies were included. We extracted 387 outcomes and consolidated these to a final list of 35 outcomes. All studies reported clinical/physiological maternal outcomes, while fewer reported on maternal mortality (10/70), life impact/functioning (8/70), adverse events (27/70), and resource use (6/70). Fetal outcomes were reported in 32 of 70 studies. There was little consistency in outcome definition.
CONCLUSION: Considerable variation exists in the reporting and definition of outcomes in studies addressing pVTE, with lack of representation from core areas other than clinical/physiological outcomes. Further work to standardize outcome reporting, and incorporation of patient-important outcomes in future research will be indispensable to advance evidence-informed and patient-centered care for this population.
OBJECTIVES: This study determined the state of outcome reporting in studies addressing prevention and management of pVTE.
METHODS: In this scoping review, we searched 7 databases including Medline, Embase, the Cochrane databases and 3 international trial registries. Clinical trials, registrations, and observational studies (prospective and retrospective) focusing on prevention or management of pVTE, published in English between 1998 and November 2018, were included. We recorded study characteristics, reported outcomes and their definitions, and categorized outcomes in accordance with a published taxonomy for outcomes in medical research. We conducted descriptive analysis to demonstrate variation in reporting and definition of outcomes and the representation of outcomes by categories in the taxonomy.
RESULTS: Of 7541 results, 70 studies were included. We extracted 387 outcomes and consolidated these to a final list of 35 outcomes. All studies reported clinical/physiological maternal outcomes, while fewer reported on maternal mortality (10/70), life impact/functioning (8/70), adverse events (27/70), and resource use (6/70). Fetal outcomes were reported in 32 of 70 studies. There was little consistency in outcome definition.
CONCLUSION: Considerable variation exists in the reporting and definition of outcomes in studies addressing pVTE, with lack of representation from core areas other than clinical/physiological outcomes. Further work to standardize outcome reporting, and incorporation of patient-important outcomes in future research will be indispensable to advance evidence-informed and patient-centered care for this population.