Artikel
Prioritization and timing of outcomes & endpoints after aneurysmal subarachnoid hemorrhage in clinical trials and observational studies – proposal of a multidisciplinary research group
Suche in Medline nach
Autoren
-
Martin Nikolaus Stienen
- Universitätspital Zürich, Klinik für Neurochirurgie, Zürich, Schweiz
-
Anne Visser-Meily
- Brain Center Rudolf Magnus, University Medical Center Utrecht, Department of Rehabilitation, Physical Therapy Science & Sports, Utrecht, Niederlande
-
Tom A. Schweizer
- St. Michael’s Hospital, University of Toronto, Department of Surgery, Division of Neurosurgery, Toronto, Kanada
-
Daniel Hänggi
- Universitätsmedizin Mannheim, Universität Heidelberg, Klinik für Neurochirurgie, Mannheim, Deutschland
-
R. Loch Macdonald
- St. Michael’s Hospital, University of Toronto, Department of Surgery, Division of Neurosurgery, Toronto, Kanada
-
Mervyn D. I. Vergouwen
- Brain Center Rudolf Magnus, University Medical Center Utrecht, Department of Neurology and Neurosurgery, Utrecht, Niederlande
| Veröffentlicht: | 18. Juni 2018 |
|---|
Gliederung
Text
Objective: In studies on aneurysmal subarachnoid hemorrhage (SAH), substantial variability exists in the use and timing of outcomes and endpoints, which complicates interpretation and comparison of results between studies. The aim of the National Institute of Health (NIH) / National Institute of Neurological Disorders and Stroke (NINDS) Unruptured Aneurysm and SAH Common Data Elements (CDE) Project was to provide a common structure for future unruptured intracranial aneurysm and SAH research.
Methods: This article summarizes the recommendations of the subcommittee on SAH Outcomes and Endpoints, which consisted of an international and multidisciplinary ad hoc panel of experts in clinical outcomes after SAH. Consensus recommendations were developed by review of previously published CDEs for other neurological diseases and the SAH literature. Recommendations for CDEs were classified by priority into "core", "supplemental – highly recommended", "supplemental" and "exploratory".
Results: We identified 60 Outcomes and Endpoints on case fatality, disability, impairment (cognitive, emotional and physical), participation restriction / return to work and health-related quality of life besides treatment variables (shunt dependency, aneurysm recanalization/re-treatment/re-rupture). None was classified as "Core". The modified Rankin Scale score (mRS) and Montreal Cognitive Assessment (MoCA) were considered the preferred outcomes and classified as Supplemental – Highly Recommended. Death, Glasgow Outcome Scale (GOS) score, and GOS-extended were classified as Supplemental. All other Outcomes and Endpoints were categorized as "Exploratory". We propose outcome assessment at 3 months, and at 12 months for studies interested in long-term outcomes. We give recommendations for standardized dichotomization of outcome scales.
Conclusion: The recommended Outcomes and Endpoints have been distilled from a broad pool of potentially useful scales, instruments and endpoints. The adherence to these recommendations will facilitate the comparison of results across studies and meta-analyses of individual patient data.
