Evidence map›Paper›PMID 17060758›Full record

SynthesisAnnals of surgery2006

The reporting of randomized clinical trials using a surgical intervention is in need of immediate improvement: a systematic review.

Isabelle Jacquier, Isabelle Boutron, David Moher, Carine Roy, Philippe Ravaud

Erratum issuedAbstract readSystematic Review
In one paragraph

Synthesis in Annals of surgery, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 52 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 9 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

52 citing papers in PubMed, 9 syntheses or guidelines pooled it.

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  4. Arthroscopic surgery for degenerative tears of the meniscus: a systematic review and meta-analysis.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2014
    Pooled it
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  6. Surrogate endpoints in liver surgery related trials: a systematic review of the literature.HPB : the official journal of the International Hepato Pancreato Biliary Association · 2013
    Pooled it
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  8. Measurement and interpretation of patient-reported outcomes in surgery: an opportunity for improvement.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2011
    Pooled it
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors.

Isabelle JacquierINSERM U738, Paris France [corrected] Assistance Publique Hôpitaux de Paris (APHP), Groupe Hospitalier Bichat-Claude Bernard, Département d'Epidémiologie Biostatistique et Recherche Clinique, Paris, France.
Isabelle Boutron
David Moher
Carine Roy
Philippe Ravaud

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the reporting of surgical interventions, care providers, and number of centers in randomized clinical trials.

methodsSystematic review was performed to assess reports of randomized controlled trials assessing surgical procedure published in 2004. A standardized abstraction form was used to extract data.

resultsA total of 158 articles were included. Details on the intervention intended, such as the surgical procedure, were reported in 138 (87.3%) articles, anesthetic management in 56 (35.4%), preoperative care in 34 (15.2%), and postoperative care in 78 (49.4%). How the experimental surgical intervention was carried out was reported in 64 articles (40.5%). Most trials were conducted in single centers (n = 109, 69.0%). The setting was reported in only 11 articles, and the volume of interventions performed was only reported in 5. Selection criteria were reported for care providers in 64 articles (40.5%). The number of care providers performing the intervention was reported in 51 articles (32.2%). The quality of reporting was low as assessed by CLEAR NPT (a 10-items checklist specifically developed to assess the reporting quality of RCTs assessing nonpharmacologic treatment).

conclusionsInadequate reporting on the management of the surgical procedure, care providers, and surgery center may introduce bias in RCTs of surgical interventions, making their results questionable. We recommend extending the CONSORT Statement to surgical interventions.

Indexed as

HumansQuality ControlRandomized Controlled Trials as TopicSurgical Procedures, Operative

Identifiers

PMID17060758
PMCPMC1856606

What OpenQuestion holds

Textmetadata
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.