Dataset Information

Current approaches to handling rescue medication in asthma and eczema randomized controlled trials are inadequate: a systematic review.

ABSTRACT: OBJECTIVES:The objective of this study was to examine how rescue medication is defined, reported, and accounted for in randomized controlled trials (RCTs) in eczema and asthma populations. STUDY DESIGN AND SETTING:This is a systematic review of phase II/III RCTs evaluating monoclonal antibodies for treating chronic eczema or asthma. A search of EMBASE, MEDLINE, and the Cochrane Central Register of Controlled Trials was conducted to identify eligible RCTs. RESULTS:Sixty published RCTs were identified, of which 60 (100%) allowed use of rescue medication but only 28 (47%) reported its use. Twenty-seven (45%) articles summarized rescue use by arm, with an average of 25% (95% CI (17%, 36%)) greater use in the placebo arm. Nine (15%) trials undertook an analysis that adjusted the primary treatment effect estimate for rescue medication use, but 8 of these used a suboptimal approach using single imputation, including 4 which used "last observation carried forward" after setting postrescue data to missing. CONCLUSION:Rescue medication use in eczema and asthma trials evaluating monoclonal antibodies is often permitted, but not routinely reported. There is evidence of imbalance in rescue use between arms, but few articles attempted to estimate a rescue-adjusted treatment effect. In trials that did, the methods used were suboptimal which could introduce bias.

SUBMITTER: Chis Ster AM

PROVIDER: S-EPMC7482905 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Current approaches to handling rescue medication in asthma and eczema randomized controlled trials are inadequate: a systematic review.

Chis Ster Anca Maria AM Cornelius Victoria V Cro Suzie S

Journal of clinical epidemiology 20200603

<h4>Objectives</h4>The objective of this study was to examine how rescue medication is defined, reported, and accounted for in randomized controlled trials (RCTs) in eczema and asthma populations.<h4>Study design and setting</h4>This is a systematic review of phase II/III RCTs evaluating monoclonal antibodies for treating chronic eczema or asthma. A search of EMBASE, MEDLINE, and the Cochrane Central Register of Controlled Trials was conducted to identify eligible RCTs.<h4>Results</h4>Sixty publ ...[more]

PMID: 32504781

Similar Datasets

Project description:The registration of clinical trials has been promoted to prevent publication bias and increase research transparency. Despite general agreement about the minimum amount of information needed for trial registration, we lack clear guidance on descriptions of non-pharmacologic interventions in trial registries. We aimed to evaluate the quality of registry descriptions of non-pharmacologic interventions assessed in ongoing randomized controlled trials (RCTs) of patient education.On 6 May 2009, we searched for all ongoing RCTs registered in the 10 trial registries accessible through the World Health Organization International Clinical Trials Registry Platform. We included trials evaluating an educational intervention (that is, designed to teach or train patients about their own health) and dedicated to participants, their family members or home caregivers. We used a standardized data extraction form to collect data related to the description of the experimental intervention, the centers, and the caregivers.We selected 268 of 642 potentially eligible studies and appraised a random sample of 150 records. All selected trials were registered in 4 registers, mainly ClinicalTrials.gov (61%). The median [interquartile range] target sample size was 205 [100 to 400] patients. The comparator was mainly usual care (47%) or active treatment (47%). A minority of records (17%, 95% CI 11 to 23%) reported an overall adequate description of the intervention (that is, description that reported the content, mode of delivery, number, frequency, duration of sessions and overall duration of the intervention). Further, for most reports (59%), important information about the content of the intervention was missing. The description of the mode of delivery of the intervention was reported for 52% of studies, the number of sessions for 74%, the frequency of sessions for 58%, the duration of each session for 45% and the overall duration for 63%. Information about the caregivers was missing for 70% of trials. Most trials (73%) took place in the United States or United Kingdom, 64% involved only one centre, and participating centers were mainly tertiary-care, academic or university hospitals (51%).Educational interventions assessed in ongoing RCTs of educational interventions are poorly described in trial registries. The lack of adequate description raises doubts about the ability of trial registration to help patients and researchers know about the treatment evaluated in trials of education.

Dataset Information

Current approaches to handling rescue medication in asthma and eczema randomized controlled trials are inadequate: a systematic review.

Publications

Current approaches to handling rescue medication in asthma and eczema randomized controlled trials are inadequate: a systematic review.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets