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

Whitehead, Laura; Perkins, Gavin D.; Clarey, Andrew; Haywood, Kirstie L.

doi:10.1016/j.resuscitation.2014.11.013

Cited by 82 publications

(69 citation statements)

References 42 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…These results are consistent with a previously published systematic review demonstrating the heterogeneity and lack of consistency in outcomes reporting in studies of cardiac arrest 17 . Like Whitehead and colleagues in prior work, we found no single outcome measure was universally or consistently assessed 17 .…”

Section: Discussionsupporting

confidence: 92%

“…After extensive deliberation, it was clear that no single primary outcome would be appropriate for all studies of cardiac arrest with recommendations for pairing a time point and physiological condition to a specific question 14 . These recommendations highlight challenges in the design and performance of RCTs in this area and the potential for great variation 17 .…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Identifying Important Gaps in Randomized Controlled Trials of Adult Cardiac Arrest Treatments

Sinha

Sukul

Lazarus

et al. 2016

Circ: Cardiovascular Quality and Outcomes

View full text Add to dashboard Cite

Background Cardiac arrests are a major public health concern worldwide. The extent and types of randomized controlled trials (RCTs) – our most reliable source of clinical evidence – conducted in these high-risk patients over recent years are largely unknown. Methods and Results We performed a systematic review, identifying all RCTs published in PubMed, EMBASE, Scopus, Web of Science, and the Cochrane Library from 1995 to 2014 that focused on acute treatment of non-traumatic cardiac arrest in adults. We then extracted data on the setting of study populations, types and timing of interventions studied, risk of bias, outcomes reported and how these factors have changed over time. Over this twenty-year period, 92 RCTs were published containing 64,309 patients (median, 225.5 per trial). Of these, 81 RCTs (88.0%) involved out-of-hospital cardiac arrest whereas 4 (4.3%) involved in-hospital cardiac arrest and 7 (7.6%) included both. Eighteen RCTs (19.6%) were performed in the U.S., 68 (73.9%) were performed outside the U.S., and 6 (6.5%) were performed in both settings. Thirty-eight RCTs (41.3%) evaluated drug therapy, 39 (42.4%) evaluated device therapy, and 15 (16.3%) evaluated protocol improvements. Seventy-four RCTs (80.4%) examined interventions during the cardiac arrest, 15 (16.3%) examined post-cardiac arrest treatment, and 3 (3.3%) studied both. Overall, reporting of risk of bias was limited. The most common outcome reported was ROSC: 86 (93.5%) with only 22 (23.9%) reporting survival beyond 6 months. Fifty-three RCTs (57.6%) reported global ordinal outcomes whereas 15 (16.3%) reported quality-of-life. RCTs in the last 5 years were more likely to be focused on protocol improvement and post-cardiac arrest care. Conclusions Important gaps in RCTs of cardiac arrest treatments exist, especially those examining in-hospital cardiac arrest, protocol improvement, post-cardiac arrest care, and long-term or quality-of-life outcomes.

show abstract

Section: Discussionsupporting

confidence: 92%

Section: Discussionmentioning

confidence: 99%

Identifying Important Gaps in Randomized Controlled Trials of Adult Cardiac Arrest Treatments

Sinha

Sukul

Lazarus

et al. 2016

Circ: Cardiovascular Quality and Outcomes

View full text Add to dashboard Cite

show abstract

“…A systematic review of cardiac arrest randomised controlled trials published between 2002 and 2012 identified 61 trials, of which only three (5%) included in-hospital cardiac arrest patients [29]. Differences between out-of-hospital and in-hospital cardiac arrest in terms of patient characteristics and clinical response limit the direct generalisability of research findings between these settings [1, 30].…”

Section: Discussionmentioning

confidence: 99%

Mechanical versus manual chest compressions in the treatment of in-hospital cardiac arrest patients in a non-shockable rhythm: a randomised controlled feasibility trial (COMPRESS-RCT)

Couper

Quinn

Lall

et al. 2018

Scand J Trauma Resusc Emerg Med

View full text Add to dashboard Cite

BackgroundMechanical chest compression devices consistently deliver high-quality chest compressions. Small very low-quality studies suggest mechanical devices may be effective as an alternative to manual chest compressions in the treatment of adult in-hospital cardiac arrest patients. The aim of this feasibility trial is to assess the feasibility of conducting an effectiveness trial in this patient population.MethodsCOMPRESS-RCT is a multi-centre parallel group feasibility randomised controlled trial, designed to assess the feasibility of undertaking an effectiveness to compare the effect of mechanical chest compressions with manual chest compressions on 30-day survival following in-hospital cardiac arrest.Over approximately two years, 330 adult patients who sustain an in-hospital cardiac arrest and are in a non-shockable rhythm will be randomised in a 3:1 ratio to receive ongoing treatment with a mechanical chest compression device (LUCAS 2/3, Jolife AB/Stryker, Lund, Sweden) or continued manual chest compressions. It is intended that recruitment will occur on a 24/7 basis by the clinical cardiac arrest team. The primary study outcome is the proportion of eligible participants randomised in the study during site operational recruitment hours. Participants will be enrolled using a model of deferred consent, with consent for follow-up sought from patients or their consultee in those that survive the cardiac arrest event.The trial will have an embedded qualitative study, in which we will conduct semi-structured interviews with hospital staff to explore facilitators and barriers to study recruitment.DiscussionThe findings of COMPRESS-RCT will provide important information about the deliverability of an effectiveness trial to evaluate the effect on 30-day mortality of routine use of mechanical chest compression devices in adult in-hospital cardiac arrest patients.Trial registrationISRCTN38139840, date of registration 9th January 2017.Electronic supplementary materialThe online version of this article (10.1186/s13049-018-0538-6) contains supplementary material, which is available to authorized users.

show abstract

“…For example, a recent review of clinical trials in resuscitation science highlighted the (not surprising) focus on short-term survival and clinician-reported outcome, but also the (surprising) failure to include the survivors' perspective or longer-term assessment of QoL [3]. While such short-term outcomes are of clear importance to clinicians and healthcare providers, they lack both relevance and trajectory for patients.…”

Section: What and When To Measure And Achieving Consensusmentioning

confidence: 99%

Using PROMs in Healthcare: Who Should Be in the Driving Seat—Policy Makers, Health Professionals, Methodologists or Patients?

Haywood

Wilson²,

Staniszewska

et al. 2016

Patient

View full text Add to dashboard Cite

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

Cited by 82 publications

References 42 publications

Identifying Important Gaps in Randomized Controlled Trials of Adult Cardiac Arrest Treatments

Identifying Important Gaps in Randomized Controlled Trials of Adult Cardiac Arrest Treatments

Mechanical versus manual chest compressions in the treatment of in-hospital cardiac arrest patients in a non-shockable rhythm: a randomised controlled feasibility trial (COMPRESS-RCT)

Using PROMs in Healthcare: Who Should Be in the Driving Seat—Policy Makers, Health Professionals, Methodologists or Patients?

Contact Info

Product

Resources

About