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

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.

Exploring the experiences and challenges for patients undergoing cranioplasty: a mixed-methods study protocol.

INTRODUCTION: Cranioplasty is a widely practised neurosurgical procedure aimed at reconstructing a skull defect, but its impact on a patient's rehabilitation following a traumatic brain injury (TBI) or stroke could be better understood. In addition, there are many issues that a TBI patient or the patient who had a stroke and their families may have to adapt to. Insight into some of the potential social barriers, including issues related to social engagement and cosmetic considerations, would be beneficial. Currently, little is known about how this procedure impacts a patient's recovery, the patient's perceptions of rehabilitation precranioplasty and postcranioplasty and the broader issues of cosmesis and social reintegration. This study hopes to understand some of these issues and therefore help inform clinicians of some of the difficulties and perceptions that patients and their relatives may have. METHODS AND ANALYSIS: A mixed-methods study. Data will be collected through focus groups with healthcare professionals (HCPs) and semi-structured interviews with patients and their relatives, field notes, a researcher diary and a patient questionnaire. Different perspectives will be brought together through method triangulation. Patient and relative data will be analysed using interpretive phenomenological analysis, and HCPs data will be analysed thematically using deductive and inductive coding. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Wales REC 7 ethics committee (Rec ref: 19/WA/0315). There is limited literature regarding a patient's perception of the cranioplasty process, the potential impact on rehabilitation and how this may impact their reintegration into the community. The results of this study will be presented at national brain injury conferences and published in peer-reviewed, national and international journals.

First Report of a Multicenter Prospective Registry of Cranioplasty in the United Kingdom and Ireland.

BACKGROUND: There are many questions that remain unanswered regarding outcomes following cranioplasty including the timing of cranioplasty following craniectomy as well as the material used. OBJECTIVE: To establish and evaluate 30-d outcomes for all cranial reconstruction procedures in the United Kingdom (UK) and Ireland through a prospective multicenter cohort study. METHODS: Patients undergoing cranioplasty insertion or revision between June 1, 2019 and November 30, 2019 in 25 neurosurgical units were included. Data collected include demographics, craniectomy date and indication, cranioplasty material and date, and 30-d outcome. RESULTS: In total, 313 operations were included, consisting of 255 new cranioplasty insertions and 58 revisions. Of the new insertions, the most common indications for craniectomy were traumatic brain injury (n = 110, 43%), cerebral infarct (n = 38, 15%), and aneurysmal subarachnoid hemorrhage (n = 30, 12%). The most common material was titanium (n = 163, 64%). Median time to cranioplasty was 244 d (interquartile range 144-385), with 37 new insertions (15%) within or equal to 90 d. In 30-d follow-up, there were no mortalities. There were 14 readmissions, with 10 patients sustaining a wound infection within 30 d (4%). Of the 58 revisions, the most common reason was due to infection (n = 33, 59%) and skin breakdown (n = 13, 23%). In 41 (71%) cases, the plate was removed during the revision surgery. CONCLUSION: This study is the largest prospective study of cranioplasty representing the first results from the UK Cranial Reconstruction Registry, a first national registry focused on cranioplasty with the potential to address outstanding research questions for this procedure.

Non-neurological organ dysfunction in neurocritical care.

PURPOSE: To determine the incidence of non-neurological organ dysfunction in patients with severe neurological injury. MATERIALS AND METHODS: Modified daily SOFA (mSOFA) scores were retrospectively calculated for 55 consecutive patients with severe head injury or subarachnoid hemorrhage. mSOFA was defined as the sum of the 5 non-neurological component SOFA scores, maximum mSOFA as the sum of the most abnormal non-neurological SOFA component scores and delta mSOFA as the difference between maximum mSOFA and admission mSOFA. Organ failure was defined as a SOFA component score > or =3. RESULTS: Median (IQR) admission, maximum and delta mSOFA scores were 4 (3-6), 8 (6-9), and 2 (1-5), respectively. Respiratory and cardiac failure developed in 80% and 82% of patients, respectively. No patient developed renal or hepatic failure. Three patients developed hematological failure. There was no difference between survivors and nonsurvivors with respect to admission mSOFA (P =.45), maximum mSOFA (P =.54), or delta mSOFA (P =.19). There was no difference between those patients with favorable or unfavorable neurological outcome with respect to admission mSOFA (P =.24), maximum mSOFA (P =.84), or delta mSOFA (P =.20). CONCLUSIONS: Cardiopulmonary failure, as defined by SOFA, is common in intensive care unit patients with severe head injury and subarachnoid hemorrhage. In contrast to other intensive care unit patient populations, the mortality of patients with closed head injury or subarachnoid hemorrhage was not related to the severity of organ dysfunction on admission or its development during the intensive care unit stay.