Dataset Information

Randomization methods in emergency setting trials: a descriptive review.

ABSTRACT: BACKGROUND:Quasi-randomization might expedite recruitment into trials in emergency care settings but may also introduce selection bias. METHODS:We searched the Cochrane Library and other databases for systematic reviews of interventions in emergency medicine or urgent care settings. We assessed selection bias (baseline imbalances) in prognostic indicators between treatment groups in trials using true randomization versus trials using quasi-randomization. RESULTS:Seven reviews contained 16 trials that used true randomization and 11 that used quasi-randomization. Baseline group imbalance was identified in four trials using true randomization (25%) and in two quasi-randomized trials (18%). Of the four truly randomized trials with imbalance, three concealed treatment allocation adequately. Clinical heterogeneity and poor reporting limited the assessment of trial recruitment outcomes. CONCLUSIONS:We did not find strong or consistent evidence that quasi-randomization is associated with selection bias more often than true randomization. High risk of bias judgements for quasi-randomized emergency studies should therefore not be assumed in systematic reviews. Clinical heterogeneity across trials within reviews, coupled with limited availability of relevant trial accrual data, meant it was not possible to adequately explore the possibility that true randomization might result in slower trial recruitment rates, or the recruitment of less representative populations.

SUBMITTER: Corbett MS

PROVIDER: S-EPMC5014172 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Randomization methods in emergency setting trials: a descriptive review.

Corbett Mark Stephen MS Moe-Byrne Thirimon T Oddie Sam S McGuire William W

Research synthesis methods 20150902 1

<h4>Background</h4>Quasi-randomization might expedite recruitment into trials in emergency care settings but may also introduce selection bias.<h4>Methods</h4>We searched the Cochrane Library and other databases for systematic reviews of interventions in emergency medicine or urgent care settings. We assessed selection bias (baseline imbalances) in prognostic indicators between treatment groups in trials using true randomization versus trials using quasi-randomization.<h4>Results</h4>Seven revie ...[more]

PMID: 26333419

Similar Datasets

Project description:BackgroundPatients with acute conditions often lack the capacity to provide informed consent, and narrow therapeutic windows mean there is no time to seek consent from surrogates prior to treatment being commenced. One method to enable the inclusion of this study population in emergency research is through recruitment without prior consent, often known as 'deferred consent'. However, empirical studies have shown a large disparity in stakeholders' opinions regarding this enrolment method. This systematic review aimed to understand different stakeholder groups' attitudes to deferred consent, particularly in relation to the context in which deferred consent might occur.MethodsDatabases including MEDLINE, EMCare, PsychINFO, Scopus, and HMIC were searched from 1996 to January 2021. Eligible studies focussed on deferred consent processes for adults only, in the English language, and reported empirical primary research. Studies of all designs were included. Relevant data were extracted and thematically coded using a narrative approach to 'tell a story' of the findings.ResultsTwenty-seven studies were included in the narrative synthesis. The majority examined patient views (n = 19). Data from the members of the public (n = 5) and health care professionals (n =5) were also reported. Four overarching themes were identified: level of acceptability of deferred consent, research-related factors influencing acceptability, personal characteristics influencing views on deferred consent, and data use after refusal of consent or participant death.ConclusionsThis review indicates that the use of deferred consent would be most acceptable to stakeholders during low-risk emergency research with a narrow therapeutic window and where there is potential for patients to benefit from their inclusion. While the use of narrative synthesis allowed assessment of the included studies, heterogeneous outcome measures meant that variations in study results could not be reliably attributed to the different trial characteristics. Future research should aim to develop guidance for research ethics committees when reviewing trials using deferred consent in emergency research and investigate more fully the views of healthcare professionals which to date have been explored less than patients and members of the public. Trial registration PROSPERO CRD42020223623.

Project description:BackgroundIn conflict settings, data to guide humanitarian and development responses are often scarce. Although geospatial analyses have been used to estimate health-care access in many countries, such techniques have not been widely applied to inform real-time operations in protracted health emergencies. Doing so could provide a more robust approach for identifying and prioritising populations in need, targeting assistance, and assessing impact. We aimed to use geospatial analyses to overcome such data gaps in Yemen, the site of one of the world's worst ongoing humanitarian crises.MethodsWe derived geospatial coordinates, functionality, and service availability data for Yemen health facilities from the Health Resources and Services Availability Monitoring System assessment done by WHO and the Yemen Ministry of Public Health and Population. We modelled population spatial distribution using high-resolution satellite imagery, UN population estimates, and census data. A road network grid was built from OpenStreetMap and satellite data and modified using UN Yemen Logistics Cluster data and other datasets to account for lines of conflict and road accessibility. Using this information, we created a geospatial network model to deduce the travel time of Yemeni people to their nearest health-care facilities.FindingsIn 2018, we estimated that nearly 8·8 million (30·6%) of the total estimated Yemeni population of 28·7 million people lived more than 30-min travel time from the nearest fully or partially functional public primary health-care facility, and more than 12·1 million (42·4%) Yemeni people lived more than 1 h from the nearest fully or partially functional public hospital, assuming access to motorised transport. We found that access varied widely by district and type of health service, with almost 40% of the population living more than 2 h from comprehensive emergency obstetric and surgical care. We identified and ranked districts according to the number of people living beyond acceptable travel times to facilities and services. We found substantial variability in access and that many front-line districts were among those with the poorest access.InterpretationThese findings provide the most comprehensive estimates of geographical access to health care in Yemen since the outbreak of the current conflict, and they provide proof of concept for how geospatial techniques can be used to address data gaps and rigorously inform health programming. Such information is of crucial importance for humanitarian and development organisations seeking to improve effectiveness and accountability.FundingGlobal Financing Facility for Women, Children, and Adolescents Trust Fund; Development and Data Science grant; and the Yemen Emergency Health and Nutrition Project, a partnership between the World Bank, UNICEF, and WHO.

Project description:IntroductionThe goal of this study was to characterize current practices in the transition of care between the emergency department and primary care setting, with an emphasis on the use of the electronic medical record (EMR).MethodsUsing literature review and modified Delphi technique, we created and tested a pilot survey to evaluate for face and content validity. The final survey was then administered face-to-face at eight different clinical sites across the country. A total of 52 emergency physicians (EP) and 49 primary care physicians (PCP) were surveyed and analyzed. We performed quantitative analysis using chi-square test. Two independent coders performed a qualitative analysis, classifying answers by pre-defined themes (inter-rater reliability > 80%). Participants' answers could cross several pre-defined themes within a given question.ResultsEPs were more likely to prefer telephone communication compared with PCPs (30/52 [57.7%] vs. 3/49 [6.1%] P < 0.0001), whereas PCPs were more likely to prefer using the EMR for discharge communication compared with EPs (33/49 [67.4%] vs. 13/52 [25%] p < 0.0001). EPs were more likely to report not needing to communicate with a PCP when a patient had a benign condition (23/52 [44.2%] vs. 2/49 [4.1%] p < 0.0001), but were more likely to communicate if the patient required urgent follow-up prior to discharge from the ED (33/52 [63.5%] vs. 20/49 [40.8%] p = 0.029). When discussing barriers to effective communication, 51/98 (52%) stated communication logistics, followed by 49/98 (50%) who reported setting/environmental constraints and 32/98 (32%) who stated EMR access was a significant barrier.ConclusionSignificant differences exist between EPs and PCPs in the transition of care process. EPs preferred telephone contact synchronous to the encounter whereas PCPs preferred using the EMR asynchronous to the encounter. Providers believe EP-to-PCP contact is important for improving patient care, but report varied expectations and multiple barriers to effective communication. This study highlights the need to optimize technology for an effective transition of care from the ED to the outpatient setting.

Dataset Information

Randomization methods in emergency setting trials: a descriptive review.

Publications

Randomization methods in emergency setting trials: a descriptive review.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets