Evidence map›Paper›PMID 32859245›Full record

SynthesisTrials2020

Reporting of key methodological and ethical aspects of cluster trials in hemodialysis require improvement: a systematic review.

Ahmed A Al-Jaishi, Kelly Carroll, Cory E Goldstein, Stephanie N Dixon, Amit X Garg, Stuart G Nicholls, Jeremy M Grimshaw, Charles Weijer, Jamie Brehaut, Lehana Thabane and 2 more

Open access · goldAbstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.8field-weighted citation impact, top 27% of its field
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

6 citing papers in PubMed, 9 citations in OpenAlex.

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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

12 authors at 5 institutions in 1 country.

Ahmed A Al-JaishiLawson Health Research Institute, London, ON, Canada. Ahmed.AlJaishi@lhsc.on.ca.ORCID http://orcid.org/0000-0003-0376-2214
Kelly CarrollClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Cory E GoldsteinDepartment of Philosophy, Western University, London, ON, Canada.
Stephanie N DixonLawson Health Research Institute, London, ON, Canada.
Amit X GargLawson Health Research Institute, London, ON, Canada.
Stuart G NichollsClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Jeremy M GrimshawClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Charles WeijerDepartment of Philosophy, Western University, London, ON, Canada.
Jamie BrehautClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Lehana ThabaneDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
P J DevereauxDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
Monica TaljaardClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Western University · CAUniversity of Ottawa · CAImpact · CAOttawa Hospital · CALawson Health Research Institute · CA

Funding

CIHR MYG-151209Heart and Stroke Foundation of Canada G-16-00012589
6 · The paper itself

Abstract

backgroundThe hemodialysis setting is suitable for trials that use cluster randomization, where intact groups of individuals are randomized. However, cluster randomized trials (CRTs) are complicated in their design, analysis, and reporting and can pose ethical challenges. We reviewed CRTs in the hemodialysis setting with respect to reporting of key methodological and ethical issues.

methodsWe conducted a systematic review of CRTs in the hemodialysis setting, published in English, between 2000 and 2019, and indexed in MEDLINE or Embase. Two reviewers extracted data, and study results were summarized using descriptive statistics.

resultsWe identified 26 completed CRTs and five study protocols of CRTs. These studies randomized hemodialysis centers (n = 17, 55%), hemodialysis shifts (n = 12, 39%), healthcare providers (n = 1, 3%), and nephrology units (n = 1, 3%). Trials included a median of 28 clusters with a median cluster size of 20 patients. Justification for using a clustered design was provided by 15 trials (48%). Methods that accounted for clustering were used during sample size calculation in 14 (45%), during analyses in 22 (71%), and during both sample size calculation and analyses in 13 trials (42%). Among all CRTs, 26 (84%) reported receiving research ethics committee approval; patient consent was reported in 22 trials: 10 (32%) reported the method of consent for trial participation and 12 (39%) reported no details about how consent was obtained or its purpose. Four trials (13%) reported receiving waivers of consent, and the remaining 5 (16%) provided no or unclear information about the consent process.

conclusionThere is an opportunity to improve the conduct and reporting of essential methodological and ethical issues in future CRTs in hemodialysis. REVIEW REGISTRATION: We conducted this systematic review using a pre-specified protocol that was not registered.

Indexed as

Abstracting and IndexingResearch DesignCluster AnalysisHumansInformed ConsentRenal DialysisCluster randomized controlled trialEthicsHemodialysisInformed consentSystematic review

Identifiers

PMID32859245
PMCPMC7456003
OpenAlexW3082234934

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.