Search

Aneurysmal subarachnoid haemorrhage (aSAH) is a devastating condition with high mortality and morbidity. The outcome measures used in aSAH clinical research vary making it challenging to compare and combine different studies. Additionally, there may be a mismatch between the outcomes prioritized by patients, caregivers, and health care providers and those selected by researchers. We conducted an international, online, multiple round Delphi study to develop consensus on domains (where a domain is a health concept or aspect) prioritized by key stakeholders including those with lived experience of aSAH, health care providers, and researchers, funders, or industry professionals. One hundred seventy-five people participated in the survey, 59% of whom had lived experience of aSAH. Over three rounds, 32 domains reached the consensus threshold pre-defined as 70% of participants rating the domain as being critically important. During the fourth round, participants ranked the importance of each of these 32 domains. The top ten domains ranked highest to lowest were (1) Cognition and executive function, (2) Aneurysm obliteration, (3) Cerebral infarction, (4) Functional outcomes including ability to walk, (5) Delayed cerebral ischemia, (6) The overall quality of life as reported by the SAH survivor, (7) Changes to emotions or mood (including depression), (8) The basic activities of daily living, (9) Vasospasm, and (10) ICU complications. Our findings confirm that there is a mismatch between domains prioritized by stakeholders and outcomes used in clinical research. Our future work aims to address this mismatch through the development of a core outcome set in aSAH research., Competing Interests: Declarations. Ethical Approval: Ethical approval for the survey development work was provided by the Ottawa Health Science Network Research Ethics Board (Reference 20210028-01H). The participants consented to participate upon registration using the web-based Delphi Manager and we informed participants that they could withdraw at any time. Conflict of Interest: Shane English is a recipient of the Heart and Stroke Foundation of Canada National New Investigator Award. The authors have no relevant financial or non-financial interests to disclose. The authors have no conflicts of interest to declare that are relevant to the content of this article. All authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest or non-financial interest in the subject matter or materials discussed in this manuscript. The authors have no financial or proprietary interests in any material discussed in this article., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background and Objectives: There is significant heterogeneity in the reporting of outcome measures in aneurysmal subarachnoid hemorrhage (aSAH) research. The modified Rankin scale (mRS) is the most commonly reported functional outcome measure. The mRS focuses on physical disability; however, many aSAH survivors experience sequalae in other domains, and the mRS may therefore not capture outcomes important to aSAH survivors. The objective of this study was to assess the clinical relevance of the mRS as a research outcome measure to people with lived aSAH experience., Methods: We conducted an international cross-sectional survey of 355 aSAH survivors, family members, and caregivers to evaluate patient-perceived outcomes in relation to the mRS. The mRS was assessed using a previously validated web-based tool., Results: Response rate was 60%; respondents from 7 continents were composed of 86% aSAH survivors and 14% family members/caregivers. Agreement between self-assessed outcome and the mRS was poor (Kappa 0.26 [CI 0.14-0.39]). Of the 172 respondents who self-assessed as having had a good aSAH outcome, 122 (71%) had a score of 0-2 on the mRS. Approximately 19% of respondents with a good outcome, based on a measured mRS score of 0-2, self-assessed as having had a poor aSAH outcome. When the mRS score was dichotomized as 0-3 corresponding to a good outcome, agreement between the score and self-assessed outcome remained poor with a Kappa score of 0.40 (CI 0.20-0.60). Approximately 30% of respondents believed that the mRS should not be used as an outcome measure in future aSAH trials., Discussion: The findings suggest that there is poor agreement between aSAH survivors' self-assessed outcome, their actual mRS score, and the dichotomization of the mRS score into good/poor outcomes. Patient-centered and patient-informed outcome measurement tools are needed to guide the aSAH research agenda., (© 2023 American Academy of Neurology.)

Objectives: The objective of the study is to externally validate three primary subarachnoid hemorrhage (pSAH) identification models., Study Design and Setting: We evaluated three models that identify pSAH using recursive partitioning (A), logistic regression (B), and a prevalence-adjusted logistic regression(C), respectively. Blinded chart review and/or linkage to existing registries determined pSAH status. We included all patients aged ≥18 in four participating center registries or whose discharge abstracts contained ≥1 administrative codes of interest between January 1, 2012 and December 31, 2013., Results: A total of 3,262 of 193,190 admissions underwent chart review (n = 2,493) or registry linkage (n = 769). A total of 657 had pSAH confirmed (20·1% sample, 0·34% admissions). The sensitivity, specificity, and positive predictive value (PPV) were as follows: i) model A: 98·3% (97·0-99·2), 53·5% (51·5-55·4), and 34·8% (32·6-37·0); ii) model B (score ≥6): 98·0% (96·6-98·9), 47·4% (45·5-49·4), and 32·0% (30·0-34·1); and iii) model C (score ≥2): 95·7% (93·9-97·2), 85·5% (84·0-86·8), and 62·3 (59·3-65·3), respectively. Model C scores of 0, 1, 2, 3, or 4 had probabilities of 0·5% (0·2-1·5), 1·5% (1·0-2·2), 24·8% (21·0-29·0), 90·0% (86·8-92·0), and 97·8% (88·7-99·6), without significant difference between centers (P = 0·86). The PPV of the International Classification of Diseases code (I60) was 63·0% (95% confidence interval: 60·0-66·0)., Conclusions: All three models were highly sensitive for pSAH. Model C could be used to adjust for misclassification bias., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objective: To systematically describe literature that identified patient/family/caregiver priorities for subarachnoid hemorrhage (SAH)-specific patient-reported outcome measures (PROMs), developed novel SAH PROMs by incorporating patient/family/caregiver perspectives, or involved patient/family/caregiver perspectives in evaluating existing SAH PROMs., Methods: We conducted a scoping review using Embase and Ovid MEDLINE from inception to February 6, 2018. Study eligibility and data extraction was performed independently and in duplicate. For each eligible citation, we abstracted information about study population, design, type of patient involvement, and outcome measures. We planned a descriptive summary of all included studies., Results: Our search yielded 4,961 citations, of which 15 met our eligibility criteria. Four of these included duplicate data, so our final sample consisted of 12 articles. There were 879 patients with SAH and 241 carers from the 11/12 articles that reported these data. One additional study involved 70 individuals but did not specify the number of carers or patients. We did not find any studies where SAH survivors or their families were directly involved in the full continuum of PROM outcome conceptualization from development to evaluation. We found 41 measures identified by patients with SAH. We identified only 2 PROMs developed with patients and only one that was a post hoc evaluation by patients. These 3 PROMs are subarachnoid hemorrhage outcome tool, Wessex Patient Carer Questionnaire, and Functional Status Examination, respectively., Conclusion: We identified 3 PROMs that have involved patients in some way, but the extent to which they reflect patient priorities remains unclear. More work is needed to ensure SAH research is not overlooking outcomes that are important to patients., (© 2019 American Academy of Neurology.)

Background: Conducting prospective epidemiological studies of hospitalized patients with rare diseases like primary subarachnoid hemorrhage (pSAH) are difficult due to time and budgetary constraints. Routinely collected administrative data could remove these barriers. We derived and validated 3 algorithms to identify hospitalized patients with a high probability of pSAH using administrative data. We aim to externally validate their performance in four hospitals across Canada., Methods: Eligible patients include those ≥18 years of age admitted to these centres from January 1, 2012 to December 31, 2013. We will include patients whose discharge abstracts contain predictive variables identified in the models (ICD-10-CA diagnostic codes I60** (subarachnoid hemorrhage), I61** (intracranial hemorrhage), 162** (other nontrauma intracranial hemorrhage), I67** (other cerebrovascular disease), S06** (intracranial injury), G97 (other postprocedural nervous system disorder) and CCI procedural codes 1JW51 (occlusion of intracranial vessels), 1JE51 (carotid artery inclusion), 3JW10 (intracranial vessel imaging), 3FY20 (CT scan (soft tissue of neck)), and 3OT20 (CT scan (abdominal cavity)). The algorithms will be applied to each patient and the diagnosis confirmed via chart review. We will assess each model's sensitivity, specificity, negative and positive predictive value across the sites., Discussion: Validating the Ottawa SAH Prediction Algorithms will provide a way to accurately identify large SAH cohorts, thereby furthering research and altering care.

Background: Whether a restrictive strategy for red blood cell (RBC) transfusion is applied to patients with aneurysmal subarachnoid hemorrhage (aSAH) is unclear. To inform the design and conduct of a future clinical trial, we sought to describe transfusion practices, hemoglobin (Hb) triggers, and predictors of RBC transfusion in patients with aSAH., Methods: This is a retrospective cohort study of all consecutively admitted adult patients with aSAH at four tertiary care centers from January 1, 2012, to December 31, 2013. Patients were identified from hospital administrative discharge records and existing local aSAH databases. Data collection by trained abstractors included demographic data, aSAH characteristics, Hb and transfusion data, other major aSAH cointerventions, and outcomes using a pretested case report form with standardized procedures. Descriptive statistics were used to summarize data, and regression models were used to identify associations between anemia, transfusion, and other relevant predictors and outcome., Results: A total of 527 patients met inclusion eligibility. Mean (±SD) age was 57 ± 13 years, and 357 patients (67.7%) were female. The median modified Fisher grade was 4 (IQR 3-4). Mean nadir Hb was 98 ± 20 g/L and occurred on median admission day 4 (IQR 2-11). RBC transfusion occurred in 100 patients (19.0%). Transfusion rates varied across centers (12.1-27.4%, p = 0.02). Patients received a median of 1 RBC unit (IQR 1-2) per transfusion episode and a median total of 2 units (IQR 1-4). Median pretransfusion Hb for first transfusion was 79 g/L (IQR 74-93) and did not vary substantially across centers (78-82 g/L, p = 0.37). Of patients with nadir Hb < 80 g/L, 66.3% received a transfusion compared with 2.0% with Hb nadir ≥ 100 g/L (p < 0.0001). Predictors of transfusion were history of oral anticoagulant use, anterior circulation aneurysm, neurosurgical clipping, and lower Hb. Controlling for numerous potential confounders, transfusion was not independently associated with poor outcome., Conclusions: We observed that moderate anemia remains very common early in admission following SAH. Only one-fifth of patients with SAH received RBC transfusions, mostly in cases of significant anemia (Hb < 80 g/L), and this did not appear to be associated with outcome.

Introduction: Anaemia is common in aneurysmal subarachnoid haemorrhage (aSAH) and is a potential critical modifiable factor affecting secondary injury. Despite physiological evidence and management guidelines that support maintaining a higher haemoglobin level in patients with aSAH, current practice is one of a more restrictive approach to transfusion. The goal of this multicentre pilot trial is to determine the feasibility of successfully conducting a red blood cell (RBC) transfusion trial in adult patients with acute aSAH and anaemia (Hb ≤100 g/L), comparing a liberal transfusion strategy (Hb ≤100 g/L) with a restrictive strategy (Hb ≤80 g/L) on the combined rate of death and severe disability at 12 months., Methods: Design This is a multicentre open-label randomised controlled pilot trial at 5 academic tertiary care centres. Population We are targeting adult aSAH patients within 14 days of their initial bleed and with anaemia (Hb ≤110 g/L). Randomisation Central computer-generated randomisation, stratified by centre, will be undertaken from the host centre. Randomisation into 1 of the 2 treatment arms will occur when the haemoglobin levels of eligible patients fall to ≤100 g/L. Intervention Patients will be randomly assigned to either a liberal (threshold: Hb ≤100 g/L) or a restrictive transfusion strategy (threshold: Hb ≤80 g/L). Outcome Primary: Centre randomisation rate over the study period. Secondary: (1) transfusion threshold adherence; (2) study RBC transfusion protocol adherence; and (3) outcome assessment including vital status at hospital discharge, modified Rankin Score at 6 and 12 months and Functional Independence Measure and EuroQOL Quality of Life Scale scores at 12 months. Outcome measures will be reported in aggregate., Ethics and Dissemination: The study protocol has been approved by the host centre (OHSN-REB 20150433-01H). This study will determine the feasibility of conducting the large pragmatic RCT comparing 2 RBC transfusion strategies examining the effect of a liberal strategy on 12-month outcome following aSAH., Trial Registration Number: NCT02483351; Pre-results., Competing Interests: Conflicts of Interest: None declared., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Objective: To create an accurate prediction model using variables collected in widely available health administrative data records to identify hospitalizations for primary subarachnoid hemorrhage (SAH)., Methods: A previously established complete cohort of consecutive primary SAH patients was combined with a random sample of control hospitalizations. Chi-square recursive partitioning was used to derive and internally validate a model to predict the probability that a patient had primary SAH (due to aneurysm or arteriovenous malformation) using health administrative data., Results: A total of 10,322 hospitalizations with 631 having primary SAH (6.1%) were included in the study (5,122 derivation, 5,200 validation). In the validation patients, our recursive partitioning algorithm had a sensitivity of 96.5% (95% confidence interval [CI] 93.9-98.0), a specificity of 99.8% (95% CI 99.6-99.9), and a positive likelihood ratio of 483 (95% CI 254-879). In this population, patients meeting criteria for the algorithm had a probability of 45% of truly having primary SAH., Conclusions: Routinely collected health administrative data can be used to accurately identify hospitalized patients with a high probability of having a primary SAH. This algorithm may allow, upon validation, an easy and accurate method to create validated cohorts of primary SAH from either ruptured aneurysm or arteriovenous malformation., (© 2016 American Academy of Neurology.)

Background: Aneurysmal subarachnoid hemorrhage (aSAH) is a devastating disease that leads to important morbidity and mortality in a young patient population. Anemia following aSAH is common and may be exacerbated by the treatments instituted by clinicians as part of standard care. The role and optimal thresholds for red blood cell (RBC) transfusion in this patient population remains unknown., Methods/design: We will conduct a systematic review of the literature using MEDLINE, EMBASE, and EBM Reviews (including Cochrane Central databases) using a comprehensive search strategy for observational and interventional studies of RBC transfusion in aSAH. Our primary objective is to evaluate the association of RBC transfusion with mortality in aSAH patients. Secondary objectives include a) determining associations between RBC transfusion and poor neurologic outcome, b) defining an optimal RBC transfusion threshold in aSAH patients, and c) describing complications associated with RBC transfusion in aSAH patients. We plan a descriptive reporting of all included citations including study characteristics, methodological quality, and reported outcomes. Clinical and statistical heterogeneity observed between studies will be described. If appropriate, meta-analyses of suitable studies and interpretation of their results will be performed. Effect measures will be converted to obtain relative risks and odds ratios (RR and ORs) with 95% confidence intervals and pooled according to study design (randomized trials and observational studies respectively) using a random effects model., Discussion: This review will summarize the existing observational and trial evidence regarding RBC transfusion in aSAH patients. The analytical plan has made considerations for different study designs, both observational and interventional in nature, and will summarize the best available evidence to inform the end user and policy and guideline producers and to highlight areas in need of further study., Systematic Review Registration: PROSPERO CRD42014014806.