Evidence map›Paper›PMID 28231757›Full record

ReviewBMC medical research methodology2017

Research waste in diagnostic trials: a methods review evaluating the reporting of test-treatment interventions.

Lavinia Ferrante di Ruffano, Jacqueline Dinnes, Sian Taylor-Phillips, Clare Davenport, Chris Hyde, Jonathan J Deeks

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

Review in BMC medical research methodology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
2.3field-weighted citation impact, top 11% 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

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Swabs versus tissue samples for infected diabetic foot ulcers: the CODIFI2 RCT.Health technology assessment (Winchester, England) · 2025
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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

6 authors at 2 institutions in 1 country.

Lavinia Ferrante di RuffanoBiostatistics, Evidence Synthesis and Test Evaluation Research Group, Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.
Jacqueline DinnesBiostatistics, Evidence Synthesis and Test Evaluation Research Group, Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.
Sian Taylor-PhillipsBiostatistics, Evidence Synthesis and Test Evaluation Research Group, Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.
Clare DavenportBiostatistics, Evidence Synthesis and Test Evaluation Research Group, Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.
Chris HydePenTAG, The Institute of Health Reseach, University of Exeter Medical School, Exeter, EX1 2LU, UK.
Jonathan J DeeksBiostatistics, Evidence Synthesis and Test Evaluation Research Group, Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK. j.deeks@bham.ac.uk.
University of Birmingham · GBUniversity of Exeter · GB

Funding

Department of Health WMCLAHRC-2014-1Medical Research Council G0600545Medical Research Council G0800808
6 · The paper itself

Abstract

backgroundThe most rigorous method for evaluating the effectiveness of diagnostic tests is through randomised trials that compare test-treatment interventions: complex interventions comprising episodes of testing, decision-making and treatment. The multi-staged nature of these interventions, combined with the need to relay diagnostic decision-making and treatment planning, has led researchers to hypothesise that test-treatment strategies may be very challenging to document. However, no reviews have yet examined the reporting quality of interventions used in test-treatment RCTs. In this study we evaluate the completeness of intervention descriptions in a systematically identified cohort of test-treatment RCTs.

methodsWe ascertained all test-treatment RCTs published 2004-2007, indexed in CENTRAL. Included trials randomized patients to diagnostic tests and measured patient outcomes after treatment. Two raters examined the completeness of test-treatment intervention descriptions in four components: 1) the test, 2) diagnostic decision-making, 3) management decision-making, 4) treatments.

resultsOne hundred and three trials compared 105 control with 119 experimental interventions, most commonly in cardiovascular medicine (35, 34%), obstetrics and gynecology (17%), gastroenterology (14%) or orthopedics (10%). A broad range of tests were evaluated, including imaging (50, 42%), biochemical assays (21%) and clinical assessment (12%). Only five (5%) trials detailed all four components of experimental and control interventions, none of which also provided a complete care pathway diagram. Experimental arms were missing descriptions of tests, diagnostic-decision making, management planning and treatments (36%, 51%, 55% and 79% of trials respectively); control arms were missing the same details in 61%, 66%, 67% and 84% of trials.

conclusionReporting of test-treatment interventions is very poor, inadequate for understanding the results of these trials, and for comparing or translating results into clinical practice. Reporting needs to improve, with greater emphasis on describing the decision-making components of care pathways in both pragmatic and explanatory trials. Please see the companion paper to this article: http://bmcmedresmethodol.biomedcentral.com/articles/10.1186/s12874-016-0287-z .

Indexed as

Biomedical ResearchGuidelines as TopicHumansOutcome Assessment, Health CareRandomized Controlled Trials as TopicReproducibility of ResultsResearch ReportDiagnostic accuracyIntervention reportingPatient outcomesRCTReporting qualityTest EvaluationTest-treatment

Identifiers

PMID28231757
PMCPMC5324286
OpenAlexW2591331643

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.