Standardizing Cranioplasty Outcomes Following Stroke or Traumatic Brain Injury: Protocol for the Development of a Core Outcome Set.

Autor:	Mee H; Division of Rehabilitation Medicine and Neurosurgery, Department of Clinical Neurosciences, Cambridge University Hospital NHS Foundation Trust, Cambridge, United Kingdom.; Division of Rehabilitation Medicine, Department of Clinical Neurosciences, Cambridge University Hospital NHS Foundation Trust, Cambridge, United Kingdom.; NIHR Global Health Research Group on NeuroTrauma, University of Cambridge, Cambridge, United Kingdom., Castaño-Leon AM; Department of Neurosurgery, Instituto de Investigación Sanitaria Hospital 12 de Octubre, Hospital Universitario 12 de Octubre, Madrid, Spain., Timofeev I; Division of Neurosurgery, Department of Clinical Neurosciences, Cambridge University Hospital NHS Foundation Trust, Cambridge, United Kingdom., Adeleye A; University of Ibadan, Ibadan, Nigeria., Devi Bhagavatula I; Department of Neurosurgery, National Institute of Mental Health and Neurosciences, Bangalore, India., Marklund N; Department of Clinical Sciences Lund, Neurosurgery, Lund University, and Skane University Hospital, Lund, Sweden., Muehlschlegel S; University of Massachusetts Medical School, Massachusetts, MA, United States., Bond K; Division of Rehabilitation Medicine, Department of Clinical Neurosciences, Cambridge University Hospital NHS Foundation Trust, Cambridge, United Kingdom., Clement C; Bristol Trials Centre, Bristol Medical School, Bristol, United Kingdom., Grieve K; Division of Neurosurgery, Department of Clinical Neurosciences, Cambridge University Hospital NHS Foundation Trust, Cambridge, United Kingdom., Owen N; Division of Neurosurgery, Department of Clinical Neurosciences, Cambridge University Hospital NHS Foundation Trust, Cambridge, United Kingdom., Whiting G; Division of Neurosurgery, Department of Clinical Neurosciences, Cambridge University Hospital NHS Foundation Trust, Cambridge, United Kingdom., Turner C; NIHR Global Health Research Group on NeuroTrauma, University of Cambridge, Cambridge, United Kingdom.; Division of Neurosurgery, Department of Clinical Neurosciences, Cambridge University Hospital NHS Foundation Trust, Cambridge, United Kingdom., Rubiano Escobar AM; Department of Neurosciences and Neurosurgery, Valle Salud IPS (Health Service Provider Institutions) Network, Cali, Colombia., Shukla D; Department of Neurosurgery, National Institute of Mental Health and Neurosciences, Bangalore, India., Paul M; Adelaide University, Adelaide, Australia., Allanson J; Division of Anaesthesia, University of Cambridge, Cambridge, United Kingdom., Pomeroy V; Neurorehabilitation Department, University of East Anglia, Norwich, United Kingdom., Viaroli E; Division of Neurosurgery, Department of Clinical Neurosciences, Cambridge University Hospital NHS Foundation Trust, Cambridge, United Kingdom., Warburton E; Division of Stroke Medicine, Department of Clinical Neurosciences, Cambridge University Hospital NHS Foundation Trust, Cambridge, United Kingdom., Wells A; Department of Neurosurgery at the University of Adelaide, University of Adelaide, Adelaide, Australia., Hawryluk G; Section of Neurosurgery, University of Manitoba, Manitoba, MB, Canada., Helmy A; Division of Neurosurgery, Department of Clinical Neurosciences, Cambridge University Hospital NHS Foundation Trust, Cambridge, United Kingdom., Anwar F; Division of Rehabilitation Medicine, Department of Clinical Neurosciences, Cambridge University Hospital NHS Foundation Trust, Cambridge, United Kingdom., Honeybul S; Department of Neurosurgery, Royal Perth Hospital, Perth, Australia., Hutchinson P; NIHR Global Health Research Group on NeuroTrauma, University of Cambridge, Cambridge, United Kingdom.; Division of Neurosurgery, Department of Clinical Neurosciences, Cambridge University Hospital NHS Foundation Trust, Cambridge, United Kingdom., Kolias A; NIHR Global Health Research Group on NeuroTrauma, University of Cambridge, Cambridge, United Kingdom.; Division of Neurosurgery, Department of Clinical Neurosciences, Cambridge University Hospital NHS Foundation Trust, Cambridge, United Kingdom.
Jazyk:	angličtina
Zdroj:	JMIR research protocols [JMIR Res Protoc] 2023 Apr 17; Vol. 12, pp. e37442. Date of Electronic Publication: 2023 Apr 17.
DOI:	10.2196/37442
Abstrakt:	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. International Registered Report Identifier (irrid): DERR1-10.2196/37442. (©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. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 17.04.2023.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu