Laura Whitehead

A systematic review of the outcomes reported in cardiac arrest clinical trials: The need for a core outcome set

BACKGROUND There is a limited guidance for outcome reporting for cardiac arrest trials. This review was conducted to explore the degree of variation and identify trends in outcome reporting. METHODS Randomised controlled trials enrolling patients with cardiac arrest (2002-2012) were identified by applying a search strategy to four databases. Titles, abstracts and short-listed studies were independently assessed for eligibility. Data on the primary and secondary outcome measures, details of outcome reporting and reproducibility were extracted. RESULTS 61 studies matched the inclusion criteria. There was wide variation in the focus, method and timing of assessment. Outcomes most commonly reported across studies were: survival (85.2%), activities (52.5%), body structure or function (41.0%), and processes of care (26.2%). Over 160 individual outcomes were reported including 39 different reports of survival measures of which 11 were measurements of ROSC (return of spontaneous circulation). Twenty different assessments of activity limitation were reported; only one was patient-reported. Many assessments were poorly defined or non-reproducible. The majority of outcomes were assessed up to hospital discharge (89.3%). There was no one outcome measure that was assessed across all trials. CONCLUSIONS Outcome reporting in cardiac arrest RCTs lacks consistency and transparency. Guidance for improved outcome reporting is urgently required to reduce this heterogeneity in reporting, improve the quality of assessment in clinical trials, and to support the synthesis of trial data. The results highlight the importance of working towards a core outcome set for cardiac arrest clinical trials to maximise the utility of future research.

The psychosocial outcomes of cardiac arrest: Relevant and robust patient-centred assessment is essential

Few people would argue with the importance of survival as an outcome of cardiac arrest. However, once patients have ‘survived’, the quality of that survival in both the short and long-term is important. Although a range of perspectives are helpful, that of the patient is crucial, contributing experience and expertise that no-other stakeholder can provide. Almost twenty years ago Berwick1 suggested that ‘The ultimate measure by which to judge the quality of a medical effort is whether it helps patients (and their families) as they see it’.

COSCA (Core Outcome Set for Cardiac Arrest) in Adults: An Advisory Statement From the International Liaison Committee on Resuscitation

Cardiac arrest effectiveness trials have traditionally reported outcomes that focus on survival. A lack of consistency in outcome reporting between trials limits the opportunities to pool results for meta-analysis. The COSCA initiative (Core Outcome Set for Cardiac Arrest), a partnership between patients, their partners, clinicians, research scientists, and the International Liaison Committee on Resuscitation, sought to develop a consensus core outcome set for cardiac arrest for effectiveness trials. Core outcome sets are primarily intended for large, randomized clinical effectiveness trials (sometimes referred to as pragmatic trials or phase III/IV trials) rather than for pilot or efficacy studies. A systematic review of the literature combined with qualitative interviews among cardiac arrest survivors was used to generate a list of potential outcome domains. This list was prioritized through a Delphi process, which involved clinicians, patients, and their relatives/partners. An international advisory panel narrowed these down to 3 core domains by debate that led to consensus. The writing group refined recommendations for when these outcomes should be measured and further characterized relevant measurement tools. Consensus emerged that a core outcome set for reporting on effectiveness studies of cardiac arrest (COSCA) in adults should include survival, neurological function, and health-related quality of life. This should be reported as survival status and modified Rankin scale score at hospital discharge, at 30 days, or both. Health-related quality of life should be measured with ≥1 tools from Health Utilities Index version 3, Short-Form 36-Item Health Survey, and EuroQol 5D-5L at 90 days and at periodic intervals up to 1 year after cardiac arrest, if resources allow.

‘Getting back to normal’: using patients’ lived experience to inform a core outcome set for cardiac arrest clinical trials

Background A recent review of outcome reporting in out of hospital cardiac arrest (OHCA) clinical trials detailed a lack of transparency and heterogeneity, highlighting the need to establish a core outcome set (COS)(Whitehead et al., 2015). Moreover, the review highlighted the dominance of outcomes which focused on the pathophysiological manifestations of the event and clinicians’ perspectives, with an absence of outcomes which sought to explore the patients’ perspective. To ensure the development of a COS with relevance and meaning to all stakeholders patients, clinicians and researchers, we sought to explore the views of patients and their partners to improve our understanding of the outcomes that really matter.