>Highlights
- •Multiple trials published in presumed predatory publications, identified through traditional electronic databases, were identified in a recent systematic review and are increasing in prevalence.
- •Trials published in presumed predatory publications were more likely to have quality, reporting and publication integrity issues than other trials. Presumed predatory publication was associated with missing trial registration and conflict of interest statement, inadequate sample size and follow-up duration, incomplete study methods and baseline reporting, and high risk of bias.
- •Presumed predatory publications were not consistently associated with patient outcomes, however, other related characteristics of poorly planned and reported studies may overestimate treatment effect.
Abstract
Objective
To comprehensively describe the quality of conduct, reporting, and publication integrity
characteristics for all trials included in a large Cochrane review, comparing those
published by presumed predatory publishers with those published by nonpredatory publishers.
Design
Cross-sectional meta-epidemiological study.
Study selection
Two hundred seventy-nine studies (25,704 participants) eligible for the recent update
of the “Exercise therapy for chronic low back pain” Cochrane review were included.
Data extraction
Study and manuscript characteristics, including predatory publication status and other
quality and integrity characteristics were extracted along with treatment effect.
Results
Nine percent of trials included were in presumed predatory publications; 12% in the
period since 2010. We found frequency of other concerning characteristics to range
from low (eg, plagiarism, 5%) to common (eg, lack of evidence of trial registration
or protocol publication [75%]; insufficient sample size [84%]) in included studies.
Studies published by presumed predatory publishers consistently had inferior conduct,
reporting and publication integrity characteristics. Presumed predatory publication
was associated with missing conflict of interest statement (OR 7.6, 95% CI 3.0–19.1),
inadequate follow-up duration (OR 11.2, 95% CI 3.7–33.7), incomplete study methods
(OR 12.1, 95% CI 2.8–52.2) and baseline reporting (OR 4.3, 95% CI 1.6–11.7), and high
risk of bias (OR 2.7, 95% CI 1.2–6.3). All (100%) presumed predatory publications
were missing trial registrations (vs. 72%) and had inadequate sample sizes (vs. 82%).
Trials published in presumed predatory journals did not appear to have inflated effect
sizes.
Conclusions
Predatory publishers pose a distinct challenge to the consumption and synthesis of
randomized controlled trials. More work is needed in other clinical areas to understand
the potential impact of randomized controlled trials published in predatory publications,
and as a result, the potential impact on evidence from systematic reviews that include
these studies.
Graphical abstract
Graphical Abstract
Keywords
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References
- Clinical trial registration: a statement from the International Committee of Medical Journal Editors.Arch Dermatol. 2005; 141: 76-77
- Statement by the International Committee of Medical Journal Editors on duplicate or redundant publication.JAMA. 1993; 270: 2495
- The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials.Lancet. 2001; 357: 1191-1194
- The singapore statement on research integrity.Accountability Res. 2011; 18: 71-75
- Predatory journals: no definition, no defence.Nature. 2019; 576: 210-212
- Predatory publishing dilutes and distorts evidence in systematic reviews.J Clin Epidemiol. 2020; 121: 117-119
- Exercise therapy for chronic low back pain.Cochr Database System Rev. 2012; CD009790https://doi.org/10.1002/14651858.CD009790
STROBE Group. STROBE statement—checklist of items that should be included in reports of observational studies. 2007. Retrieved from https://www.strobe-statement.org/fileadmin/Strobe/uploads/checklists/STROBE_checklist_v4_combined.pdf
- updated method guideline for systematic reviews in the Cochrane Back and Neck Group.Spine. 2015; 40: 1660-1673
Distiller SR. Ottawa, ON: Evidence Partners, 2020.
- CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials.Trials. 2010; 11: 32
International Committee of Medical Journal Editors. Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals. Retrieved from http://www.icmje.org/recommendations/
Journalytics [Internet]. Cabells International [cited 21 Sep 2020]. Retrieved from https://www2.cabells.com/about-journalytics
- Outcome measures for low back pain research: a proposal for standardized use.Spine. 1998; 23: 2003-2013
- Core outcome domains for clinical trials in non-specific low back pain.Eur Spine J. 2015; 24: 1127-1142
- The clinical course of low back pain: a meta-analysis comparing outcomes in randomised clinical trials (RCTs) and observational studies.BMC Musculoskelet Disord. 2014; 15: 68
- Low back pain symptoms show a similar pattern of improvement following a wide range of primary care treatments: a systematic review of randomized clinical trials.Rheumatology (Oxford, England). 2010; 49: 2346-2356
Higgins JP. Cochrane handbook for systematic reviews of interventions. Version 5.1. 0 [updated March 2011]. The Cochrane Collaboration. www. cochrane-handbook. org. 2011.
- RoB 2: a revised tool for assessing risk of bias in randomised trials.Br Med J. 2019; 366https://doi.org/10.1136/bmj.l4898
iThenticate. iThenticate Plagiarism Detection Software 2020.
- Strategies for using plagiarism software in the screening of incoming journal manuscripts: recommendations based on a recent literature survey.Basic Clin Pharmacol Toxicol. 2016; 119: 161-164
- Plagiarism in submitted manuscripts: incidence, characteristics and optimization of screening—case study in a major specialty medical journal.Res Integrity Peer Rev. 2016; 1: 13
- Plagiarism detectors are a crutch, and a problem.Nature. 2019; 567: 435-436
- Penalized logistic regression with low prevalence exposures beyond high dimensional settings.PloS One. 2019; 14e0217057
- Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale.Eur J Pain. 2004; 8: 283-291
- Minimal clinically important difference. Low back pain: outcome measures.J Rheumatol. 2001; 28: 431-438
- Open access physical therapy journals: do predatory journals publish lower-quality randomized controlled trials?.Arch Phys Med Rehab. 2020; 101: 969-977
- Predatory publications in evidence syntheses.J Med Libr Assoc. 2019; 107: 57-61
- Academic research integrity: exploring researchers’ perceptions of responsibilities and enablers.Accountability Res. 2020; 27: 146-177
- Academic criteria for promotion and tenure in biomedical sciences faculties: cross sectional analysis of international sample of universities.Br Med J. 2020; 369: m2081
Laakso M, Matthias L, Jahn N. Open is not forever: a study of vanished open access journals. arXiv preprint arXiv:2008.11933. 2020 Aug 27.
Article info
Publication history
Published online: February 02, 2021
Accepted:
January 20,
2021
Received in revised form:
January 7,
2021
Received:
October 19,
2020
Identification
Copyright
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