Protocol for a cluster randomised controlled feasibility study of Prehospital Optimal Shock Energy for Defibrillation (POSED)

Pocock, Helen; Deakin, Charles D.; Lall, Ranjit; Michelet, Felix; Contreras, Abraham; Ainsworth-Smith, Mark; King, P. D. C.; Devrell, Anne; Smith, Debra E.; Perkins, Gavin D

doi:10.1016/j.resplu.2022.100310

Cited by 4 publications

(4 citation statements)

References 27 publications

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“…9 10 During our recent cardiac arrest trial our patient and public partners cautiously stated their preference for actively informing the relatives of non-surviving patients. 11 With no UK precedent we sought the experience of researchers elsewhere. There is a need for a structured investigation to describe the different approaches taken by researchers across the world to inform the relatives of non-survivors which may guide others and inform practice.…”

Section: Original Researchmentioning

confidence: 99%

Systematic analysis of approaches used in cardiac arrest trials to inform relatives about trial enrolment of non-surviving patients

Pocock,

Dove,

Pointeer

et al. 2024

Emerg Med J

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BackgroundThe recruitment of patients to emergency research studies without the requirement for prior informed consent has furthered the conduct of randomised studies in cardiac arrest. Frameworks enabling this vary around the world depending on local legal or ethical requirements. When an enrolled patient does not survive, researchers may take one of three approaches to inform relatives of their enrolment: a direct (active) approach, providing information indirectly (passively) and inviting relatives to seek further information if they choose, or providing no information about the trial (no attempt). Previous studies have described experiences of US researchers’ active approach but there is little known about approaches elsewhere.We aimed to conduct a structured investigation of methods used in cardiac arrest trials to provide information about trial enrolment to relatives of non-surviving patients.MethodsWe systematically searched trial registries to identify randomised clinical trials that recruited cardiac arrest patients. Trials were eligible for inclusion if they recruited adults during cardiac arrest (or within 1 hour of return of spontaneous circulation) between 2010 and 2022 (in the decade prior to study conception). We extracted data from trial registries and, where relevant, published papers and protocols. Investigators were contacted and asked to describe the style, rationale and timing of approach to relatives of non-surviving patients. We present descriptive statistics.ResultsOur trial registry search identified 710 unique trials, of which 108 were eligible for inclusion. We obtained information from investigators for 64 (62%) trials. Approximately equal numbers of trials attempted to actively inform relatives of non-survivors (n=28 (44% (95% CI; 31% to 57%))), or made no attempt (n=25 (39% (95% CI; 27% to 52%))). The remaining studies provided general information about the trial to relatives but did not actively inform them (n=11 (17% (95% CI; 8% to 29%))).ConclusionsThere is wide variability in the approach taken to informing relatives of non-surviving patients enrolled in cardiac arrest randomised clinical trials.

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Section: Original Researchmentioning

confidence: 99%

Systematic analysis of approaches used in cardiac arrest trials to inform relatives about trial enrolment of non-surviving patients

Pocock,

Dove,

Pointeer

et al. 2024

Emerg Med J

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“… 8 Thus, there was great excitement within the resuscitation community when the Prehospital Optimal Shock Energy for Defibrillation (POSED) trial protocol was registered and published for an out-of-hospital cardiac arrest trial of three defibrillation strategies (120–150–200 J, 150–200–200 J or 200–200–200 J). 9 …”

mentioning

confidence: 99%

“…POSED is a three-arm cluster randomised controlled feasibility study. 9 Feasibility studies are a type of preliminary study that includes testing the design and whether the proposed research can be successfully carried out. 10 These studies consider broader concepts than a pilot study testing a trial protocol, including the barriers and enablers to implementation field 11 and often include qualitative components.…”

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confidence: 99%

Defibrillation trials: POSED a challenge

Nehme,

Bray

2024

Resuscitation Plus

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“…We welcome the publication of cardiac arrest study protocols, such as the recently published Prehospital Optimal Shock Energy for Defibrillation randomised controlled trial and EuReCa three observational study protocols. 14 , 17 The journal has, in line with other journals, committed to an expedited review of protocols of externally funded studies. This expedited process comprises an editorial review that focusses only on assessing adherence to relevant reporting checklists, such as SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) checklist or PRISMA-P (Preferred reporting items for systematic review and meta-analysis protocols).…”

mentioning

confidence: 99%