What to Measure in Aneurysmal Subarachnoid Haemorrhage Research-An International Delphi Survey.
Cerebral aneurysm
Core outcome set
Patient-important outcomes
Subarachnoid hemorrhage
Journal
Translational stroke research
ISSN: 1868-601X
Titre abrégé: Transl Stroke Res
Pays: United States
ID NLM: 101517297
Informations de publication
Date de publication:
13 Jul 2024
13 Jul 2024
Historique:
received:
07
05
2024
accepted:
17
06
2024
revised:
13
06
2024
medline:
13
7
2024
pubmed:
13
7
2024
entrez:
12
7
2024
Statut:
aheadofprint
Résumé
Aneurysmal subarachnoid haemorrhage (aSAH) is a devastating condition with high mortality and morbidity. The outcome measures used in aSAH clinical research vary making it challenging to compare and combine different studies. Additionally, there may be a mismatch between the outcomes prioritized by patients, caregivers, and health care providers and those selected by researchers. We conducted an international, online, multiple round Delphi study to develop consensus on domains (where a domain is a health concept or aspect) prioritized by key stakeholders including those with lived experience of aSAH, health care providers, and researchers, funders, or industry professionals. One hundred seventy-five people participated in the survey, 59% of whom had lived experience of aSAH. Over three rounds, 32 domains reached the consensus threshold pre-defined as 70% of participants rating the domain as being critically important. During the fourth round, participants ranked the importance of each of these 32 domains. The top ten domains ranked highest to lowest were (1) Cognition and executive function, (2) Aneurysm obliteration, (3) Cerebral infarction, (4) Functional outcomes including ability to walk, (5) Delayed cerebral ischemia, (6) The overall quality of life as reported by the SAH survivor, (7) Changes to emotions or mood (including depression), (8) The basic activities of daily living, (9) Vasospasm, and (10) ICU complications. Our findings confirm that there is a mismatch between domains prioritized by stakeholders and outcomes used in clinical research. Our future work aims to address this mismatch through the development of a core outcome set in aSAH research.
Identifiants
pubmed: 38997598
doi: 10.1007/s12975-024-01271-8
pii: 10.1007/s12975-024-01271-8
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Investigateurs
Brenda Lucas
(B)
Informations de copyright
© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.
Références
Shin S, Lee Y, Chang WH, Sohn MK, Lee J, Kim DY, et al. Multifaceted assessment of functional outcomes in survivors of first-time stroke. JAMA Netw Open. 2022;5:e2233094–e2233094.
doi: 10.1001/jamanetworkopen.2022.33094
pubmed: 36149652
pmcid: 9508656
English SW, Chassé M, Turgeon AF, Lauzier F, Griesdale D, Garland A, et al. Anemia prevalence and incidence and red blood cell transfusion practices in aneurysmal subarachnoid hemorrhage: Results of a multicenter cohort study. Crit Care. 2018;21:169.
doi: 10.1186/s13054-018-2089-7
Nieuwkamp DJ, Setz LE, Algra A, Linn FH, de Rooij NK, Rinkel GJ. Changes in case fatality of aneurysmal subarachnoid haemorrhage over time, according to age, sex, and region: a meta-analysis. Lancet Neurol. 2009;8:635–42.
doi: 10.1016/S1474-4422(09)70126-7
pubmed: 19501022
Al-Khindi T, Macdonald RL, Schweizer TA. Cognitive and functional outcome after aneurysmal subarachnoid hemorrhage. Stroke. 2010;41:e519–36.
doi: 10.1161/STROKEAHA.110.581975
pubmed: 20595669
Springer MV, Schmidt JM, Wartenberg KE, Frontera JA, Badjatia N, Mayer SA. Predictors of global cognitive impairment 1 year after subarachnoid hemorrhage. Neurosurgery. 2009;65:1041–3.
doi: 10.1227/01.NEU.0000359317.15269.20
Kirkham JJ, Gargon E, Clarke M, Williamson PR. Can a core outcome set improve the quality of systematic reviews? - A survey of the Co-ordinating Editors of Cochrane review groups. Trials. 2013;14(1):21.
doi: 10.1186/1745-6215-14-21
pubmed: 23339751
pmcid: 3575292
Andersen CR, Fitzgerald E, Delaney A, Finfer S. A systematic review of outcome measures employed in aneurysmal subarachnoid hemorrhage (aSAH) clinical research. Neurocrit Care. 2019;30:534–41.
doi: 10.1007/s12028-018-0566-0
pubmed: 29951958
Crowe S, Fenton M, Hall M, Cowan K, Chalmers I. Patients’, clinicians’ and the research communities’ priorities for treatment research: there is an important mismatch. Res Involv Engagem. 2015;1:1–10.
Tallon D, Chard J, Dieppe P. Relation between agendas of the research community and the research consumer. Lancet. 2000;355:2037–40.
doi: 10.1016/S0140-6736(00)02351-5
pubmed: 10885355
Buchanan KM, Elias LJ, Goplen GB. Differing perspectives on outcome after subarachnoid hemorrhage: the patient, the relative, the neurosurgeon. Neurosurgery. 2000;46(4):831–40.
pubmed: 10764256
Fung C, Beck J, Lauber L, Müri R, Raabe A, Nyffeler T. Clinical assessment of deficits after SAH: hasty neurosurgeons and accurate neurologists. J Neurol. 2012;259(10):2198–201.
doi: 10.1007/s00415-012-6483-9
pubmed: 22527224
Rudberg AS, Berge E, Laska AC, Jutterström S, Näsman P, Sunnerhagen KS, et al. Stroke survivors’ priorities for research related to life after stroke. Top Stroke Rehabil. 2020;28:153–8.
doi: 10.1080/10749357.2020.1789829
pubmed: 32627722
Pollock A, St George B, Fenton M, Firkins L. Top 10 research priorities relating to life after stroke - consensus from stroke survivors, caregivers, and health professionals. Int J Stroke. 2014;9(3):313–20.
doi: 10.1111/j.1747-4949.2012.00942.x
pubmed: 23227818
Andersen CR, Presseau J, Saigle V, Etminan N, Vergouwen MDI, English SW. Core outcomes for subarachnoid haemorrhage. Lancet Neurol Lancet Publishing Group. 2019;18(12):1075–6.
doi: 10.1016/S1474-4422(19)30412-0
Beaton D, Maxwell L, Grosskleg S, Shea B, Tugwell P. The OMERACT Handbook Version 2.1. OMERACT; 2021.
Williamson PR, Altman DG, Bagley H, Barnes KL, Blazeby JM, Brookes ST, et al. The COMET Handbook: version 1.0. Trials. 2017;18:280.
doi: 10.1186/s13063-017-1978-4
pubmed: 28681707
pmcid: 5499094
Sinha IP, Smyth RL, Williamson PR. Using the Delphi technique to determine which outcomes to measure in clinical trials: recommendations for the future based on a systematic review of existing studies. PLoS Med. 2011;8:1–5.
doi: 10.1371/journal.pmed.1000393
Williamson PR, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E, et al. Developing core outcome sets for clinical trials: issues to consider. Trials. 2012 Aug 6;13:132. https://doi.org/10.1186/1745-6215-13-132 .
Sharma A, Minh Duc NT, Luu Lam Thang T, Nam NH, Ng SJ, Abbas KS, et al. A consensus-based checklist for reporting of survey studies (CROSS). J Gen Intern Med. 2021;36:3179–87.
Andersen C, English S. COMET initiative: core outcomes for subarachnoid haemorrhage. COMET. 2016 [cited 2023 Feb 9]. https://www.comet-initiative.org/Studies/Details/1198
Okoli C, Pawlowski SD. The Delphi method as a research tool: an example, design considerations and applications. Inf Manag. 2004;42(1):15–29.
doi: 10.1016/j.im.2003.11.002
Turnbull AE, Dinglas VD, Friedman LA, Chessare CM, Sepúlveda KA, Bingham CO, et al. A survey of Delphi panelists after core outcome set development revealed positive feedback and methods to facilitate panel member participation. J Clin Epidemiol. 2018;102:99–106.
doi: 10.1016/j.jclinepi.2018.06.007
pubmed: 29966731
pmcid: 7419147
Haywood K, Whitehead L, Nadkarni VM, Achana F, Beesems S, Böttiger BW, et al. COSCA (Core Outcome Set for Cardiac Arrest) in adults: an advisory statement from the International Liaison Committee on Resuscitation. Circulation. 2018;137:e783-801.
doi: 10.1161/CIR.0000000000000562
pubmed: 29700122
Turnbull AE, Sepulveda KA, Dinglas VD, Chessare CM, Bingham CO, Needham DM. Core domains for clinical research in acute respiratory failure survivors: an international modified Delphi consensus study. Crit Care Med. 2017;45:1001.
doi: 10.1097/CCM.0000000000002435
pubmed: 28375853
pmcid: 5433919
Blackwood B, Ringrow S, Clarke M, Marshall JC, Connolly B, Rose L, et al. A core outcome set for critical care ventilation trials. Crit Care Med. 2019;47:1324–31.
doi: 10.1097/CCM.0000000000003904
pubmed: 31356474
Keeley T, Williamson P, Callery P, Jones LL, Mathers J, Jones J, et al. The use of qualitative methods to inform Delphi surveys in core outcome set development. Trials. 2016;17:230. https://doi.org/10.1186/s13063-016-1356-7 .
Maxwell LJ, Beaton DE, Boers M, D’Agostino MA, Conaghan PG, Grosskleg S, et al. The evolution of instrument selection for inclusion in core outcome sets at OMERACT: Filter 2.2. Semin Arthritis Rheum. 2021;51:1320–30.
doi: 10.1016/j.semarthrit.2021.08.011
pubmed: 34544617
Boers M, Kirwan JR, Wells G, Beaton D, Gossec L, d’Agostino M-A, et al. Developing core outcome measurement sets for clinical trials: OMERACT Filter 2.0. J Clin Epidemiol. 2014;67:745–53.
doi: 10.1016/j.jclinepi.2013.11.013
pubmed: 24582946
Andersen CR, Presseau J, Saigle V, Fitzgerald E, Lamanna M, Talbot P, et al. Prioritizing outcome measures after aneurysmal subarachnoid hemorrhage: a q-sort survey of patients, health care providers and researchers. Front Neurol. 2022;0:2653.