Evidence map›Paper›PMID 35338066›Full record

ArticleBMJ open2022

Evaluation of the design, conduct and reporting of randomised controlled trials in the haemodialysis population: a scoping review and interview study.

Prachi Kaushal, Sherna F Adenwalla, Courtney J Lightfoot, Daniel S March, Laura J Gray, James O Burton

Open access · goldAbstract readScoping Review
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.3field-weighted citation impact, top 18% 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

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. 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

6 authors at 1 institution in 1 country.

Prachi KaushalDepartment of Cardiovascular Sciences, University of Leicester, Leicester, UK.ORCID 0000-0002-8012-389X
Sherna F AdenwallaDepartment of Cardiovascular Sciences, University of Leicester, Leicester, UK.
Courtney J LightfootDepartment of Health Sciences, University of Leicester, Leicester, UK.
Daniel S MarchDepartment of Cardiovascular Sciences, University of Leicester, Leicester, UK.
Laura J GrayDepartment of Health Sciences, University of Leicester, Leicester, UK.
James O BurtonDepartment of Cardiovascular Sciences, University of Leicester, Leicester, UK jb343@le.ac.uk.ORCID 0000-0003-1176-7592
University of Leicester · GB

Funding

Department of Health
6 · The paper itself

Abstract

backgroundFewer trials are conducted in nephrology than any other specialty, often failing to recruit to target, resulting in unclear evidence affecting translation to clinical practice. This mixed-methods study aims to provide guidance for designing and reporting future randomised controlled trials (RCTs) in the haemodialysis population.

methodA scoping review was conducted. Five databases (MEDLINE, Cumulative Index to Nursing and Allied Health Literature, Embase, Cochrane Central Register of Controlled Trials and ClinicalTrials.gov) were searched for RCTs published between 2013 and 2019 involving prevalent adult haemodialysis patients. Reporting of sample size, recruitment, retention and statistical significance of primary outcome were assessed. Face-to-face semistructured interviews were conducted with individuals from a single centre during dialysis sessions. Interviews were analysed thematically.

resultsOf 786 RCTs identified, 636 (80.9%) were parallel-group, 139 (17.7%) were crossover and 11 (1.4%) were cluster (including one stepped-wedge) design. Sample size justification was reported in 73.1%, 53.8% and 45.5% of parallel-group, crossover and cluster trials, respectively.Target recruitment was achieved by 45.5% of cluster, 53.8% of crossover and 57.7% of parallel-group trials with patient retention at 75.6%, 83.1% and 87.8%, respectively. Primary outcome reached statistical significance in 81.8% of cluster trials, 69.2% of parallel-group and 38.5% of crossover trials.Themes identified from individual interviews: perceptions of the convenience of trial participation; group allocation; perceptions of the benefits and adverse effects of taking part in clinical trials.

conclusionThe recruitment and reporting of RCTs involving people on haemodialysis could be improved. Involvement of all stakeholders and especially participants in the trial design process may address issues around participant burden and ultimately improve the evidence base for clinical practice.

Indexed as

Renal DialysisAdultHumansQualitative ResearchRandomized Controlled Trials as TopicSample Sizeclinical trialclustercrossoverhaemodialysisparallel grouprandomised controlled trial (RCT)stepped wedgetrial designtrial reporting

Identifiers

PMID35338066
PMCPMC8961160
OpenAlexW4220671623

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.