Reporting on blinding in trial protocols and corresponding publications was often inadequate but rarely contradictory
Abstract
Objective To compare the reporting on blinding in protocols and articles describing randomized controlled trials.Study design and setting We studied 73 protocols of trials approved by the scientific/ethical committees for Copenhagen and Frederiksberg, 1994 and 1995, and their corresponding publications.Results Three out of 73 trials (4%) reported blinding in the protocol that contradicted that in the publication (e.g., "open" vs. "double blind"). The proportion of "double-blind" trials with a clear description of the blinding of participants increased from 11 out of 58 (19%) when based on publications alone to 39 (67%) when adding the information in the protocol. The similar proportions for the blinding of health care providers were 2 (3%) and 22 (38%); and for the blinding of data collectors, they were 8 (14%) and 14 (24%). In 52 of 58 publications (90%), it was unclear whether all patients, health care providers, and data collectors had been blinded. In 4 of the 52 trials (7%), the protocols clarified that all three key trial persons had been blinded.Conclusions The reporting on blinding in both trial protocols and publications is often inadequate. We suggest developing international guidelines for the reporting of trial protocols and public access to protocols.
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Blinding procedures are not always reported even when procedures have been adequately implemented.
“Blinding procedures are not always reported even when procedures have been adequately implemented [83, 84].”
From Blinding outcome assessors in randomised controlled trials of psychological interventions: how is it done? A narrative review (2026) · cites this paper as [84]
Concerns about inadequate reporting of key content in trial protocols provided the impetus for the development of the original SPIRIT statement published in 2013.
“Concerns about inadequate reporting of key content in trial protocols3 4 5 provided the impetus for the development of the original SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement published in 2013.6”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [5]
The completeness of trial protocols varies and key elements are often not considered.
“yet their completeness varies and key elements are often not considered”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [5]
Blinding has often been poorly described in trial protocols.
“Despite its importance, blinding has often been poorly described in trial protocols.5”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [5]
In a sample of protocols from 1994, out of 55 protocols of trials planned as double blind, five (9%) provided no information beyond double blind, 25 (45%) reported a double dummy procedure, and 32 (58%) reported the compared interventions as being similar.
“The reporting in trial protocols of plans for inducing and maintaining blinding was studied in a sample of protocols from 1994.5 Out of 55 protocols of trials planned as double blind, five (9%) provided no information beyond double blind, 25 (45%) reported a double dummy procedure, and 32 (58%) reported the compared interventions as being similar.”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [5]
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- Authors
- Hróbjartsson, A., Pildal, J., Chan, A.-W., Haahr, M. T., Altman, D. G., & Gøtzsche, P. C.
- Affiliations
- Rigshospitalet (DK)
- Mayo Clinic (US)
- University of Oxford (GB)
- Corresponding author
- Hróbjartsson, Asbjørn
- Venue
- Journal of Clinical Epidemiology
- Publisher
- Elsevier BV
- Published
- 2009-09
- Volume
- 62
- Issue
- 9
- Pages
- 967-973
- ISSN
- 0895-4356 (ISSN-L)
- OpenAlex
- W1982848674
- Cited by
- 56
- References
- 19
- Citations by year
- 2026: 2 · 2025: 2 · 2023: 1 · 2022: 5 · 2021: 2 · 2020: 5 · 2018: 2 · 2017: 3 · 2016: 2 · 2015: 3 · 2014: 3 · 2013: 5 · 2012: 9
- FWCI
- 8.27
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Epidemiology (publishedVersion)
- PubMed (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (publishedVersion)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Keywords
- blinding, randomized controlled trials, reporting guidelines
- MeSH terms
- Clinical Protocols, Double-Blind Method, Humans, Periodicals as Topic, Publishing, Research Design, Randomized Controlled Trials as Topic
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