Standardising cranioplasty outcomes following stroke or traumatic brain injury: Protocol for the development of a Core Outcome Set

Mee, Harry, Castaño-Leon, Ana M., Timofeev, Ivan, Adeleye, Amos, Devi Bhagavatula, Indira, Marklund, Niklas, Muehlschlegel, Susanne, Bond, Katie, Clement, Clare, Grieve, Kirsty, Owen, Nicola, Whiting, Gemma, Turner, Carole, Rubiano Escobar, Andres Mariano, Shukla, Dhaval, Paul, Maria, Allanson, Judith, Pomeroy, Valerie ORCID:, Viaroli, Edoardo, Warburton, Elizabeth, Wells, Adam, Hawryluk, Gregory, Helmy, Adel, Anwar, Fahim, Honeybul, Stephen, Hutchinson, Peter and Kolias, Angelos (2023) Standardising cranioplasty outcomes following stroke or traumatic brain injury: Protocol for the development of a Core Outcome Set. JMIR Research Protocols, 12. ISSN 1929-0748

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Background: Core outcome sets (COSs) are important and necessary as they help standardize reporting in research studies. Cranioplasty following traumatic brain injury (TBI) or stroke is becoming increasingly common, leading to an ever-growing clinical and research interest, especially regarding the optimal material, cost-effectiveness, and timing of cranioplasty concerning neurological recovery and complications. Consequently, heterogeneous reporting of outcomes from such diverse studies has led to limited meta-analysis ability and an ongoing risk of outcome reporting bias. This study aims to define a standardized COS for reporting in all future TBI and stroke cranioplasty studies. Objective: This study has four aims: (1) undertake a systematic review to collate the most current outcome measures used within the cranioplasty literature; (2) undertake a qualitative study to understand better the views of clinicians, patients' relatives, and allied health professionals regarding clinical outcomes following cranioplasty; (3) undertake a Delphi survey as part of the process of gaining consensus for the COS; and (4) finalize consensus through a consensus meeting resulting in the COS. Methods: An international steering committee has been formed to guide the development of the COS. In addition, recommendations from other clinical initiatives such as COMET (Core Outcomes and Effectiveness Trials) and OMERACT (Outcome Measures in Rheumatology) have been adhered to. Phase 1 is data collection through a systematic review and qualitative study. Phase 2 is the COS development through a Delphi survey and consensus meetings with consensus definitions decided and agreed upon before the Delphi survey begins to avoid bias. Results: Phase 1 started at the end of 2019, following ethical approval in December 2019, and the project completion date is planned for the end of 2022 or beginning of 2023. Conclusions: This study should result in a consensus on a COS for cranioplasty, following TBI or stroke, to help standardize outcome reporting for future studies, which can be applied to future research and clinical services, help align future studies, build an increased understanding of cranioplasty and its impact on a patient’s function and recovery, and help standardize the evidence base.

Item Type: Article
Additional Information: Funding Information: This project has been funded by the Division of Academic Neurosurgery, University of Cambridge. Funding Information: The authors have no personal, financial, or institutional interest in any drugs, materials, or devices described in this article. PH is supported by the NIHR (Senior Investigator Award, Cambridge BRC) and the Royal College of Surgeons of England. Publisher Copyright: © Harry Mee, Ana M Castaño-Leon, Ivan Timofeev, Amos Adeleye, Indira Devi Bhagavatula, Niklas Marklund, Susanne Muehlschlegel, Katie Bond, Clare Clement, Kirsty Grieve, Nicola Owen, Gemma Whiting, Carole Turner, Andres Mariano Rubiano Escobar, Dhaval Shukla, Maria Paul, Judith Allanson, Valerie Pomeroy, Edoardo Viaroli, Elizabeth Warburton, Adam Wells, Gregory Hawryluk, Adel Helmy, Fahim Anwar, Stephen Honeybul, Peter Hutchinson, Angelos Kolias.
Uncontrolled Keywords: comet,tbi,core outcome set,cranioplasty,domains,health interventions,neurological,neurology,outcome,recovery,reporting,stroke,traumatic brain injury,medicine(all) ,/dk/atira/pure/subjectarea/asjc/2700
Faculty \ School: Faculty of Medicine and Health Sciences > School of Health Sciences
UEA Research Groups: Faculty of Medicine and Health Sciences > Research Centres > Norwich Institute for Healthy Aging
Faculty of Medicine and Health Sciences > Research Groups > Rehabilitation
Faculty of Medicine and Health Sciences > Research Centres > Lifespan Health
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Depositing User: LivePure Connector
Date Deposited: 06 Jul 2022 08:30
Last Modified: 19 Oct 2023 03:22
DOI: 10.2196/37442


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