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

Harry Mee, Ana Castano Leon, Ivan Timofeev, Amos Adeleye, Indira Devi, Niklas Marklund, Susanne Muehlschlegel, Katie Bond, Clare Clement, Kirsty Grieve, Nicola Owen, Gemma Whiting, Carole Turner, Andres Rubiano, Dhaval Shukla, Maria Paul, Judith Allanson, Valerie Pomeroy, Edoardo Viaroli, Elizabeth WarburtonAdam Wells, Gregory Hawryluk, Adel Helmy, Fahim Anwar, Stephen Honeybul, Peter Hutchinson, Angelos Kolias

Research output: Contribution to journalArticlepeer-review


Background: Core Outcome sets (COS) are important and necessary as they help standardise reporting in research studies. Cranioplasty following traumatic brain injury 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 a limited meta-analysis ability and an ongoing risk of outcome reporting bias. This study aims to define a standardised COS for reporting in all future TBI and stroke cranioplasty studies.

Objective: 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. 4. Finalise 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/beginning of 2023.

Conclusions: This study should result in consensus on a COS for cranioplasty following TBI or stroke to help standardise outcome reporting for future studies, which can be applied to future research, and clinical services, helping to align future studies, building an increased understanding of cranioplasty and its impact on a patients function and recovery as well as helping to standardise the evidence base.

International Registered Report: DERR1-10.2196/37442
Original languageEnglish
JournalJMIR Research Protocols
Early online date17 Oct 2022
Publication statusE-pub ahead of print - 17 Oct 2022

Cite this