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Standardizing 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 ; Bhagavatula, Indira Devi ; Marklund, Niklas LU orcid ; Muehlschlegel, Susanne ; Bond, Katie ; Clement, Clare and Grieve, Kirsty , et al. (2023) In JMIR Research Protocols 12.
Abstract

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... (More)

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.

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publishing date
type
Contribution to journal
publication status
published
subject
keywords
COMET, core outcome set, cranioplasty, domains, health Interventions, neurological, neurology, outcome, recovery, reporting, stroke, TBI, traumatic brain injury
in
JMIR Research Protocols
volume
12
article number
e37442
publisher
JMIR Publications Inc.
external identifiers
  • scopus:85158888603
  • pmid:35759752
ISSN
1929-0748
DOI
10.2196/37442
language
English
LU publication?
yes
id
3f50cd72-8fce-4e02-af03-4ce72e5426dd
date added to LUP
2023-08-15 13:18:58
date last changed
2024-12-15 01:39:14
@article{3f50cd72-8fce-4e02-af03-4ce72e5426dd,
  abstract     = {{<p>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.</p>}},
  author       = {{Mee, Harry and Castaño-Leon, Ana M. and Timofeev, Ivan and Adeleye, Amos and Bhagavatula, Indira Devi and Marklund, Niklas and Muehlschlegel, Susanne and Bond, Katie and Clement, Clare and Grieve, Kirsty and Owen, Nicola and Whiting, Gemma and Turner, Carole and Escobar, Andres Mariano Rubiano and Shukla, Dhaval and Paul, Maria and Allanson, Judith and Pomeroy, Valerie and Viaroli, Edoardo and Warburton, Elizabeth and Wells, Adam and Hawryluk, Gregory and Helmy, Adel and Anwar, Fahim and Honeybul, Stephen and Hutchinson, Peter and Kolias, Angelos}},
  issn         = {{1929-0748}},
  keywords     = {{COMET; core outcome set; cranioplasty; domains; health Interventions; neurological; neurology; outcome; recovery; reporting; stroke; TBI; traumatic brain injury}},
  language     = {{eng}},
  publisher    = {{JMIR Publications Inc.}},
  series       = {{JMIR Research Protocols}},
  title        = {{Standardizing Cranioplasty Outcomes Following Stroke or Traumatic Brain Injury : Protocol for the Development of a Core Outcome Set}},
  url          = {{http://dx.doi.org/10.2196/37442}},
  doi          = {{10.2196/37442}},
  volume       = {{12}},
  year         = {{2023}},
}