ArticlePloS one2017
Worldwide trends in volume and quality of published protocols of randomized controlled trials.
Article in PloS one, 2017. 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 14 papers.
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.
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.
Who cites it
14 citing papers in PubMed.
- How can we make sound replication decisions?Proceedings of the National Academy of Sciences of the United States of America · 2025Article
- Protocol publication rate and comparison between article, registry and protocol in RCTs.BMC medical research methodology · 2025Article
- Lack of transparent reporting of trial monitoring approaches in randomised controlled trials: A systematic review of contemporary protocol papers.Clinical trials (London, England) · 2023Article
- The Effects of the Ukrainian Conflict on Oncological Care: The Latest State of the Art.Healthcare (Basel, Switzerland) · 2023Article
- Preferred Methods of Measuring Work Participation: An International Survey Among Trialists and Cochrane Systematic Reviewers.Journal of occupational rehabilitation · 2022Article
- Impact of advanced practice nurses in hospital units on compliance with clinical practice guidelines: a quasi-experimental study.BMC nursing · 2022Article
- Examining the Development of Information Needs Assessment Questionnaires in Oncology: Protocol for a Scoping Review.JMIR research protocols · 2022Article
- Article
- Comparison of six statistical methods for interrupted time series studies: empirical evaluation of 190 published series.BMC medical research methodology · 2021Article
- Article
- Articles provided insufficient information to conduct an appropriate retrospective assessment of the pragmatic/explanatory features of medicine trials with the PRECIS-2 tool.European journal of clinical pharmacology · 2020Article
- E-SCOPE: A Strategic Approach to Identify and Accelerate Implementation of Evidence-based Best Practices.Medical care · 2019Article
- Behavioral trials in the Arab Gulf States: A scoping review.SAGE open medicine · 2019Article
- Correction: Worldwide trends in volume and quality of published protocols of randomized controlled trials.PloS one · 2017Article
Corrections and comments
- Erratum issued
Authors and funding
7 authors.
Funding
Abstract
introductionPublishing protocols of randomized controlled trials (RCT) facilitates a more detailed description of study rational, design, and related ethical and safety issues, which should promote transparency. Little is known about how the practice of publishing protocols developed over time. Therefore, this study describes the worldwide trends in volume and methodological quality of published RCT protocols.
methodsA systematic search was performed in PubMed and EMBASE, identifying RCT protocols published over a decade from 1 September 2001. Data were extracted on quality characteristics of RCT protocols. The primary outcome, methodological quality, was assessed by individual methodological characteristics (adequate generation of allocation, concealment of allocation and intention-to-treat analysis). A comparison was made by publication period (First, September 2001- December 2004; Second, January 2005-May 2008; Third, June 2008-September 2011), geographical region and medical specialty.
resultsThe number of published RCT protocols increased from 69 in the first, to 390 in the third period (p<0.0001). Internal medicine and paediatrics were the most common specialty topics. Whereas most published RCT protocols in the first period originated from North America (n = 30, 44%), in the second and third period this was Europe (respectively, n = 65, 47% and n = 190, 48%, p = 0.02). Quality of RCT protocols was higher in Europe and Australasia, compared to North America (OR = 0.63, CI = 0.40-0.99, p = 0.04). Adequate generation of allocation improved with time (44%, 58%, 67%, p = 0.001), as did concealment of allocation (38%, 53%, 55%, p = 0.03). Surgical protocols had the highest quality among the three specialty topics used in this study (OR = 1.94, CI = 1.09-3.45, p = 0.02).
conclusionPublishing RCT protocols has become popular, with a five-fold increase in the past decade. The quality of published RCT protocols also improved, although variation between geographical regions and across medical specialties was seen. This emphasizes the importance of international standards of comprehensive training in RCT methodology.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.