A call for improving the internal validity and the reporting of manual therapy trials self-labelled as pragmatic: A methodological review

IF 1.1 4区医学 Q2 MEDICINE, GENERAL & INTERNAL

International Journal of Osteopathic Medicine Pub Date : 2025-02-08 DOI:10.1016/j.ijosm.2025.100754

S. Roura , G. Alvarez , D. Hohenschurz-Schmidt , I. Solà , R. Núñez-Cortés , J. Bracchiglione , C. Fernández-Jané , J. Phalip , I. Gich , M. Sitjà-Rabert , G. Urrútia

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引用次数: 0

Abstract

Objectives

This study provides further data from a review assessing methodological characteristics of pragmatic randomised controlled trials (pRCTs) published in manual therapy (MT). In this second part, we aim to assess the report, the risk of bias (RoB), and the relationship between these items and the pragmatism scores of the self-labelled pRCTs in the MT field.

Study design and setting

We searched MEDLINE and the Cochrane Central Register of Controlled Trials for pRCTs in the MT field from inception to January 2024. Two independent reviewers screened the trials using several CONSORT extensions and assessed them using the Cochrane Risk of Bias tool. We performed a descriptive analysis using frequencies and percentages and a relation analysis between the trials' pragmatism, their reporting, and their RoB.

Results

We included 39 self-labelled MT pRCTs. Compliance with CONSORT items was higher than 70 % in one-third of the included trials (13/39) but varied across items. Performance and detection bias were the main threats to internal validity (we rated 90 %, 35/39, and 77 %; 30/39 of trials at high risk of bias, respectively). Selective reporting bias was unclear in almost half of the sample (46 %; 18/39). No relation was found between the highly pragmatic attitude and good reporting except for CONSORT item 25 (Sources of funding and other support) (p = 0.006). No relation was found between the RoB and the pragmatic attitude of the studies. The percentage of compliance with CONSORT items was higher in the trials with low RoB.

Conclusion

Pragmatic trials in MT have significant methodological limitations, and their reporting is suboptimal. Nonetheless, trials with less risk of bias had higher compliance with CONSORT items.

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来源期刊

International Journal of Osteopathic Medicine 医学-医学：内科

CiteScore

2.20

自引率

36.80%

发文量

审稿时长

3 months

期刊介绍： The International Journal of Osteopathic Medicine is a peer-reviewed journal that provides for the publication of high quality research articles and review papers that are as broad as the many disciplines that influence and underpin the principles and practice of osteopathic medicine. Particular emphasis is given to basic science research, clinical epidemiology and health social science in relation to osteopathy and neuromusculoskeletal medicine. The Editorial Board encourages submission of articles based on both quantitative and qualitative research designs. The Editorial Board also aims to provide a forum for discourse and debate on any aspect of osteopathy and neuromusculoskeletal medicine with the aim of critically evaluating existing practices in regard to the diagnosis, treatment and management of patients with neuromusculoskeletal disorders and somatic dysfunction. All manuscripts submitted to the IJOM are subject to a blinded review process. The categories currently available for publication include reports of original research, review papers, commentaries and articles related to clinical practice, including case reports. Further details can be found in the IJOM Instructions for Authors. Manuscripts are accepted for publication with the understanding that no substantial part has been, or will be published elsewhere.