Evidence map›Paper›PMID 35613804›Full record

ArticleBMJ open2022

Reporting quality of clinical trial protocols: a repeated cross-sectional study about the Adherence to SPIrit Recommendations in Switzerland, CAnada and GErmany (ASPIRE-SCAGE).

Dmitry Gryaznov, Belinda von Niederhäusern, Benjamin Speich, Benjamin Kasenda, Elena Ojeda-Ruiz, Anette Blümle, Stefan Schandelmaier, Dominik Mertz, Ayodele Odutayo, Yuki Tomonaga and 26 more

Abstract read
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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 12 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing 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

12 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
  3. Pooled it
  4. Review
  5. [Interpretation and Examples: Key Updates in SPIRIT 2025 Statement].Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition · 2025
    Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
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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

36 authors.

Dmitry GryaznovBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.ORCID 0000-0002-2361-6794
Belinda von NiederhäusernDepartment of Clinical Research, Clinical Trial Unit, University Hospital Basel and University of Basel, Basel, Switzerland.
Benjamin SpeichBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.ORCID 0000-0002-3301-8085
Benjamin KasendaBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.
Elena Ojeda-RuizBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.ORCID 0000-0002-4620-7010
Anette BlümleClinical Trials Unit, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.
Stefan SchandelmaierBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.
Dominik MertzDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.ORCID 0000-0003-4337-1613
Ayodele OdutayoOxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Yuki TomonagaEpidemiology, Biostatistic und Prevention Institute, University of Zurich, Zurich, Switzerland.
Alain AmstutzBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.ORCID 0000-0003-1716-993X
Christiane Pauli-MagnusDepartment of Clinical Research, Clinical Trial Unit, University Hospital Basel and University of Basel, Basel, Switzerland.
Viktoria GloyBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.
Szimonetta LohnerCochrane Hungary, Clinical Centre of the University of Pécs, Medical School, University of Pécs, Pécs, Hungary.
Karin BischoffCochrane Germany, Cochrane Germany Foundation, Freiburg, Germany.
Katharina WollmannCochrane Germany, Cochrane Germany Foundation, Freiburg, Germany.
Laura RehnerInstitute for Evidence in Medicine, Medical Center, University of Freiburg, Freiburg, Germany.
Joerg J MeerpohlCochrane Germany, Cochrane Germany Foundation, Freiburg, Germany.
Alain NordmannBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.
Katharina KlatteDepartment of Clinical Research, Clinical Trial Unit, University Hospital Basel and University of Basel, Basel, Switzerland.
Nilabh GhoshDepartment of Neurosurgery, University of Basel, Basel, Switzerland.
Ala Taji HeraviBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.
Jacqueline WongDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Ngai ChowDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Patrick HongDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Kimberly A McCord-De IacoBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.
Sirintip SricharoenchaiBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.
Jason W BusseDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.ORCID 0000-0002-0178-8712
Arnav AgarwalDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.ORCID 0000-0002-0931-7851
Ramon SaccilottoBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.
Matthias SchwenkglenksEpidemiology, Biostatistic und Prevention Institute, University of Zurich, Zurich, Switzerland.
Giusi MoffaBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.
Lars HemkensBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.
Sally HopewellOxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Erik Von ElmCochrane Switzerland, Centre for Primary Care and Public Health (unisanté), University of Lausanne, Lausanne, Switzerland.ORCID 0000-0002-7412-0406
Matthias BrielBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland Matthias.Briel@usb.ch.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesComprehensive protocols are key for the planning and conduct of randomised clinical trials (RCTs). Evidence of low reporting quality of RCT protocols led to the publication of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist in 2013. We aimed to examine the quality of reporting of RCT protocols from three countries before and after the publication of the SPIRIT checklist.

designRepeated cross sectional study.

settingSwiss, German and Canadian research ethics committees (RECs).

participantsRCT protocols approved by RECs in 2012 (n=257) and 2016 (n=292). PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcomes were the proportion of reported SPIRIT items per protocol and the proportion of trial protocols reporting individual SPIRIT items. We compared these outcomes in protocols approved in 2012 and 2016, and built regression models to explore factors associated with adherence to SPIRIT. For each protocol, we also extracted information on general trial characteristics and assessed whether individual SPIRIT items were reported

resultsThe median proportion of reported SPIRIT items among RCT protocols showed a non-significant increase from 72% (IQR, 63%-79%) in 2012 to 77% (IQR, 68%-82%) in 2016. However, in a preplanned subgroup analysis, we detected a significant improvement in investigator-sponsored protocols: the median proportion increased from 64% (IQR, 55%-72%) in 2012 to 76% (IQR, 64%-83%) in 2016, while for industry-sponsored protocols median adherence was 77% (IQR 72%-80%) for both years. The following trial characteristics were independently associated with lower adherence to SPIRIT: single-centre trial, no support from a clinical trials unit or contract research organisation, and investigator-sponsorship.

conclusionsIn 2012, industry-sponsored RCT protocols were reported more comprehensively than investigator-sponsored protocols. After publication of the SPIRIT checklist, investigator-sponsored protocols improved to the level of industry-sponsored protocols, which did not improve.

Indexed as

Ethics Committees, ResearchCanadaCross-Sectional StudiesGermanyHumansSwitzerlandClinical trialsEPIDEMIOLOGYProtocols & guidelines

Identifiers

PMID35613804
PMCPMC9125701

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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.