Evidence map›Paper›PMID 33115541›Full record

ArticleTrials2020

Rationale and design of repeated cross-sectional studies to evaluate the reporting quality of trial protocols: the Adherence to SPIrit REcommendations (ASPIRE) study and associated projects.

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

Abstract read
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In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 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

7 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. 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 GryaznovDepartment of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Spitalstrasse 12, 4031, Basel, Switzerland. dmitry.gryaznov@usb.ch.ORCID http://orcid.org/0000-0002-2361-6794
Ayodele OdutayoApplied Health Research Centre, Li Ka Shing Knowledge Instiute of St Michael's Hospital, Toronto, Canada.
Belinda von NiederhäusernDepartment of Clinical Research, Clinical Trial Unit, University Hospital Basel and University of Basel, Basel, Switzerland.
Benjamin SpeichDepartment of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Spitalstrasse 12, 4031, Basel, Switzerland.
Benjamin KasendaDepartment of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Spitalstrasse 12, 4031, Basel, Switzerland.
Elena Ojeda-RuizDepartment of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Spitalstrasse 12, 4031, Basel, Switzerland.
Anette BlümleInstitute for Evidence in Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Stefan SchandelmaierDepartment of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Spitalstrasse 12, 4031, Basel, Switzerland.
Dominik MertzDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
Yuki TomonagaEpidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.
Alain AmstutzDepartment of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Spitalstrasse 12, 4031, Basel, Switzerland.
Christiane Pauli-MagnusDepartment of Clinical Research, Clinical Trial Unit, University Hospital Basel and University of Basel, Basel, Switzerland.
Viktoria GloyDepartment of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Spitalstrasse 12, 4031, Basel, Switzerland.
Karin BischoffInstitute for Evidence in Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Katharina WollmannInstitute for Evidence in Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Laura RehnerInstitute for Evidence in Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Szimonetta LohnerCochrane Hungary, Clinical Centre of the University of Pécs, Medical School, University of Pécs, Pécs, Hungary.
Joerg J MeerpohlInstitute for Evidence in Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Alain NordmannDepartment of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Spitalstrasse 12, 4031, Basel, Switzerland.
Katharina KlatteDepartment of Clinical Research, Clinical Trial Unit, University Hospital Basel and University of Basel, Basel, Switzerland.
Nilabh GhoshDepartment of Neurosurgery and Department of Biomedicine, University Hospital Basel, University of Basel, Basel, Switzerland.
Ala Taji HeraviDepartment of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Spitalstrasse 12, 4031, Basel, Switzerland.
Jacqueline WongDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
Ngai ChowDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
Patrick Jiho HongDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
Kimberly Mc CordDepartment of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Spitalstrasse 12, 4031, Basel, Switzerland.
Sirintip SricharoenchaiDepartment of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Spitalstrasse 12, 4031, Basel, Switzerland.
Jason W BusseDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
Arnav AgarwalDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
Ramon SaccilottoDepartment of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Spitalstrasse 12, 4031, Basel, Switzerland.
Matthias SchwenkglenksEpidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.
Giusi MoffaDepartment of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Spitalstrasse 12, 4031, Basel, Switzerland.
Lars G HemkensDepartment of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Spitalstrasse 12, 4031, Basel, Switzerland.
Sally HopewellOxford Clinical Trials Research Unit and 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.
Matthias BrielDepartment of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Spitalstrasse 12, 4031, Basel, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundClearly structured and comprehensive protocols are an essential component to ensure safety of participants, data validity, successful conduct, and credibility of results of randomized clinical trials (RCTs). Funding agencies, research ethics committees (RECs), regulatory agencies, medical journals, systematic reviewers, and other stakeholders rely on protocols to appraise the conduct and reporting of RCTs. In response to evidence of poor protocol quality, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guideline was published in 2013 to improve the accuracy and completeness of clinical trial protocols. The impact of these recommendations on protocol completeness and associations between protocol completeness and successful RCT conduct and publication remain uncertain. OBJECTIVES AND

methodsAims of the Adherence to SPIrit REcommendations (ASPIRE) study are to investigate adherence to SPIRIT checklist items of RCT protocols approved by RECs in the UK, Switzerland, Germany, and Canada before (2012) and after (2016) the publication of the SPIRIT guidelines; determine protocol features associated with non-adherence to SPIRIT checklist items; and assess potential differences in adherence across countries. We assembled an international cohort of RCTs based on 450 protocols approved in 2012 and 402 protocols approved in 2016 by RECs in Switzerland, the UK, Germany, and Canada. We will extract data on RCT characteristics and adherence to SPIRIT for all included protocols. We will use multivariable regression models to investigate temporal changes in SPIRIT adherence, differences across countries, and associations between SPIRIT adherence of protocols with RCT registration, completion, and publication of results. We plan substudies to examine the registration, premature discontinuation, and non-publication of RCTs; the use of patient-reported outcomes in RCT protocols; SPIRIT adherence of RCT protocols with non-regulated interventions; the planning of RCT subgroup analyses; and the use of routinely collected data for RCTs. DISCUSSION: The ASPIRE study and associated substudies will provide important information on the impact of measures to improve the reporting of RCT protocols and on multiple aspects of RCT design, trial registration, premature discontinuation, and non-publication of RCTs observing potential changes over time.

Indexed as

Clinical Trial Protocols as TopicCross-Sectional StudiesCanadaEthics Committees, ResearchGermanyHumansSwitzerlandRandomized clinical trialsRegistrationReporting guideline adherenceReporting qualityTrial discontinuationTrial protocol

Identifiers

PMID33115541
PMCPMC7594472

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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.