Evidence map›Paper›PMID 32847919›Full record

ArticleBMJ open2020

Has the reporting quality of published randomised controlled trial protocols improved since the SPIRIT statement? A methodological study.

Zet Wei Tan, Aidan Christopher Tan, Tom Li, Ian Harris, Justine M Naylor, Michiel Siebelt, Jasper van Tiel, Marina Pinheiro, Laura Harris, Kira Chamberlain and 1 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 3 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

23 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Dissemination planning in exercise oncology trials-a systematic review of trial protocols.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Pooled it
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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

11 authors.

Zet Wei TanFaculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.
Aidan Christopher TanSouth Western Sydney Clinical School, University of New South Wales, Sydney, New South Wales, Australia.ORCID 0000-0003-0354-4006
Tom LiFaculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.
Ian HarrisSouth Western Sydney Clinical School, University of New South Wales, Sydney, New South Wales, Australia.
Justine M NaylorSouth Western Sydney Clinical School, University of New South Wales, Sydney, New South Wales, Australia.
Michiel SiebeltOrthopaedics, Erasmus Medical Center, Rotterdam, Zuid-Holland, The Netherlands.
Jasper van TielOrthopaedics, Erasmus Medical Center, Rotterdam, Zuid-Holland, The Netherlands.
Marina PinheiroInstitute for Musculoskeletal Health, The University of Sydney, Sydney, New South Wales, Australia.
Laura HarrisSydney Orthopaedic Trauma and Reconstructive Surgery, Sydney, New South Wales, Australia.
Kira ChamberlainSydney Orthopaedic Trauma and Reconstructive Surgery, Sydney, New South Wales, Australia.
Sam AdieSouth Western Sydney Clinical School, University of New South Wales South Western Sydney Clinical School, Liverpool, New South Wales, Australia sam.adie@gmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo determine the reporting quality of published randomised controlled trial (RCT) protocols before and after the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement (2013), and any association with author, trial or journal factors.

designMethodological study. DATA SOURCES: MEDLINE, Embase and CENTRAL were electronically searched using optimised search strategies. ELIGIBILITY CRITERIA: Protocols written for an RCT of living humans, published in full text in a peer-reviewed journal and published in the English language. MAIN OUTCOME: Primary outcome was the overall proportion of checklist items which were adequately reported in RCT protocols published before and after the SPIRIT statement.

results300 RCT protocols were retrieved; 150 from the period immediately before the SPIRIT statement (9 July 2012 to 28 December 2012) and 150 from a recent period after the SPIRIT statement (25 January 2019 to 20 March 2019). 47.9% (95% CI, 46.5% to 49.3%) of checklist items were adequately reported in RCT protocols before the SPIRIT statement and 56.7% (95% CI, 54.9% to 58.5%) after the SPIRIT statement. This represents an 8.8% (95% CI, 6.6% to 11.1%; p<0.0001) mean improvement in the overall proportion of checklist items adequately reported since the SPIRIT statement. While 40% of individual checklist items had a significant improvement in adequate reporting after the SPIRIT statement, 11.3% had a significant deterioration and there were no RCT protocols in which all individual checklist items were complete. The factors associated with higher reporting quality of RCT protocols in multiple regression analysis were author expertise or experience in epidemiology or statistics, multicentre trials, longer protocol word length and publicly reported journal policy of compliance with the SPIRIT statement.

conclusionThe overall reporting quality of RCT protocols has significantly improved since the SPIRIT statement, although a substantial proportion of individual checklist items remain poorly reported. Continued and concerted efforts are required by journals, editors, reviewers and investigators to improve the completeness and transparency of RCT protocols.

Indexed as

ChecklistPublicationsHumansRandomized Controlled Trials as TopicResearch Personnelclinical trialsepidemiologyprotocols & guidelinesquality in health carestatistics & research methods

Identifiers

PMID32847919
PMCPMC7451949

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.