Evidence map›Paper›PMID 31043183›Full record

SynthesisInfection control and hospital epidemiology2019

Design, implementation, and analysis considerations for cluster-randomized trials in infection control and hospital epidemiology: A systematic review.

Lyndsay M O'Hara, Natalia Blanco, Surbhi Leekha, Kristen A Stafford, Gerard P Slobogean, Emilie Ludeman, Anthony D Harris, CDC Prevention Epicenters Program

Abstract readSystematic Review
In one paragraph

Synthesis in Infection control and hospital epidemiology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Lyndsay M O'HaraDepartment of Epidemiology and Public Health,University of Maryland School of Medicine,Baltimore, Maryland.
Natalia BlancoDepartment of Epidemiology and Public Health,University of Maryland School of Medicine,Baltimore, Maryland.ORCID 0000-0002-3157-1119
Surbhi LeekhaDepartment of Epidemiology and Public Health,University of Maryland School of Medicine,Baltimore, Maryland.
Kristen A StaffordDepartment of Epidemiology and Public Health,University of Maryland School of Medicine,Baltimore, Maryland.
Gerard P SlobogeanDepartment of Orthopaedics,University of Maryland School of Medicine,Baltimore, Maryland.
Emilie LudemanUniversity of Maryland Health Sciences and Human Services Library,Baltimore, Maryland.
Anthony D HarrisDepartment of Epidemiology and Public Health,University of Maryland School of Medicine,Baltimore, Maryland.
CDC Prevention Epicenters Program

Funding

K24 Clinical Research in Antimicrobial Resistance and Hospital EpidemiologyK24AI079040 · NIAID · UNIVERSITY OF MARYLAND BALTIMORE · PI HARRIS, ANTHONY D · 2009 to 2018
$1.8M
ACL HHS U54CK000450NCEZID CDC HHS U54 CK000450NIAID NIH HHS K24 AI079040
6 · The paper itself

Abstract

backgroundIn cluster-randomized trials (CRT), groups rather than individuals are randomized to interventions. The aim of this study was to present critical design, implementation, and analysis issues to consider when planning a CRT in the healthcare setting and to synthesize characteristics of published CRT in the field of healthcare epidemiology.

methodsA systematic review was conducted to identify CRT with infection control outcomes.

resultsWe identified the following 7 epidemiological principles: (1) identify design type and justify the use of CRT; (2) account for clustering when estimating sample size and report intraclass correlation coefficient (ICC)/coefficient of variation (CV); (3) obtain consent; (4) define level of inference; (5) consider matching and/or stratification; (6) minimize bias and/or contamination; and (7) account for clustering in the analysis. Among 44 included studies, the most common design was CRT with crossover (n = 15, 34%), followed by parallel CRT (n = 11, 25%) and stratified CRT (n = 7, 16%). Moreover, 22 studies (50%) offered justification for their use of CRT, and 20 studies (45%) demonstrated that they accounted for clustering at the design phase. Only 15 studies (34%) reported the ICC, CV, or design effect. Also, 15 studies (34%) obtained waivers of consent, and 7 (16%) sought consent at the cluster level. Only 17 studies (39%) matched or stratified at randomization, and 10 studies (23%) did not report efforts to mitigate bias and/or contamination. Finally, 29 studies (88%) accounted for clustering in their analyses.

conclusionsWe must continue to improve the design and reporting of CRT to better evaluate the effectiveness of infection control interventions in the healthcare setting.

Indexed as

HospitalsRandomized Controlled Trials as TopicCluster AnalysisEpidemiologic StudiesHumansInfection ControlResearch ReportSample Size

Identifiers

PMID31043183
PMCPMC6897299

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.