Evidence map›Paper›PMID 32207574›Full record

SynthesisBJS open2020

Systematic review of reporting benefits and harms of surgical interventions in randomized clinical trials.

F E Stubenrouch, E S Cohen, P M M Bossuyt, M J W Koelemay, P C R van der Vet, D T Ubbink

Abstract readSystematic Review
In one paragraph

Synthesis in BJS open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
–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

11 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Observational
  6. Review
  7. Article
  8. Harms Reporting Is Inadequate in Systematic Reviews Regarding Hip Arthroscopy.Arthroscopy, sports medicine, and rehabilitation · 2023
    Article
  9. Article
  10. Review
  11. Review
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.

F E StubenrouchDepartment of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.ORCID 0000-0002-8411-9556
E S CohenFaculty of Medicine, University of Amsterdam, Amsterdam, the Netherlands.
P M M BossuytDepartment of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
M J W KoelemayDepartment of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
P C R van der VetFaculty of Medicine, University of Amsterdam, Amsterdam, the Netherlands.
D T UbbinkDepartment of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundStandardized reporting methods facilitate comparisons between studies. Reporting of data on benefits and harms of treatments in surgical RCTs should support clinical decision-making. Correct and complete reporting of the outcomes of clinical trials is mandatory to appreciate available evidence and to inform patients properly before asking informed consent.

methodsRCTs published between January 2005 and January 2017 in 15 leading journals comparing a surgical treatment with any other treatment were reviewed systematically. The CONSORT checklist, including the extension for harms, was used to appraise the publications. Beneficial and harmful treatment outcomes, their definitions and their precision measures were extracted.

resultsOf 1200 RCTs screened, 88 trials were included. For the differences in effect size of beneficial outcomes, 68 per cent of the trials reported a P value only but not a 95 per cent confidence interval. For harmful effects, this was 67 per cent. Only five of the 88 trials (6 per cent) reported a number needed to treat, and no study a number needed to harm. Only 61 per cent of the trials reported on both the beneficial and harmful outcomes of the intervention studied in the same paper.

conclusionDespite CONSORT guidelines, current reporting of benefits and harms in surgical trials does not facilitate clear communication of treatment outcomes with patients. Researchers, reviewers and journal editors should ensure proper reporting of treatment benefits and harms in trials.

Indexed as

ChecklistHumansPeriodicals as TopicPublishingRandomized Controlled Trials as TopicSurgical Procedures, Operative

Identifiers

PMID32207574
PMCPMC7093777

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.