Reporting and transparent research practices in sports medicine and orthopaedic clinical trials: a meta-research study

被引:9
|
作者
Schulz, Robert [1 ,2 ]
Langen, Georg [3 ]
Prill, Robert [4 ]
Cassel, Michael [2 ]
Weissgerber, Tracey L. [1 ]
机构
[1] Charite Univ Med Berlin, Berlin Inst Hlth, BIH QUEST Ctr Responsible Res, Berlin, Germany
[2] Univ Potsdam, Dept Sport & Hlth Sci, Potsdam, Brandenburg, Germany
[3] Inst Appl Training Sci, Dept Strength Power & Tact Sports, Leipzig, Germany
[4] Brandenburg Med Sch Theodor Fontane, Ctr Orthopaed & Traumatol, Neuruppin, Brandenburg, Germany
来源
BMJ OPEN | 2022年 / 12卷 / 08期
关键词
clinical trials; statistics & research methods; sports medicine; rehabilitation medicine; orthopaedic & trauma surgery; medical education & training; QUESTIONABLE RESEARCH PRACTICES; INTERNATIONAL-COMMITTEE; EXERCISE MEDICINE; BIAS; GUIDELINES; STATEMENT;
D O I
10.1136/bmjopen-2021-059347
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objectives Transparent reporting of clinical trials is essential to assess the risk of bias and translate research findings into clinical practice. While existing studies have shown that deficiencies are common, detailed empirical and field-specific data are scarce. Therefore, this study aimed to examine current clinical trial reporting and transparent research practices in sports medicine and orthopaedics. Setting Exploratory meta-research study on reporting quality and transparent research practices in orthopaedics and sports medicine clinical trials. Participants The sample included clinical trials published in the top 25% of sports medicine and orthopaedics journals over 9 months. Primary and secondary outcome measures Two independent reviewers assessed pre-registration, open data and criteria related to scientific rigour, like randomisation, blinding, and sample size calculations, as well as the study sample, and data analysis. Results The sample included 163 clinical trials from 27 journals. While the majority of trials mentioned rigour criteria, essential details were often missing. Sixty per cent (95% confidence interval (CI) 53% to 68%) of trials reported sample size calculations, but only 32% (95% CI 25% to 39%) justified the expected effect size. Few trials indicated the blinding status of all main stakeholders (4%; 95% CI 1% to 7%). Only 18% (95% CI 12% to 24%) included information on randomisation type, method and concealed allocation. Most trials reported participants' sex/gender (95%; 95% CI 92% to 98%) and information on inclusion and exclusion criteria (78%; 95% CI 72% to 84%). Only 20% (95% CI 14% to 26%) of trials were pre-registered. No trials deposited data in open repositories. Conclusions These results will aid the sports medicine and orthopaedics community in developing tailored interventions to improve reporting. While authors typically mention blinding, randomisation and other factors, essential details are often missing. Greater acceptance of open science practices, like pre-registration and open data, is needed. As these practices have been widely encouraged, we discuss systemic interventions that may improve clinical trial reporting.
引用
收藏
页数:13
相关论文
共 50 条
  • [21] Pilot trials may improve the quality of full-scale trials: a meta-research study
    Ying, Xiangji
    Ehrhardt, Stephan
    JOURNAL OF CLINICAL EPIDEMIOLOGY, 2023, 160 : 117 - 125
  • [22] Placebo response and effect in randomized clinical trials: meta-research with focus on contextual effects
    Sigurlaug H. Hafliðadóttir
    Carsten B. Juhl
    Sabrina M. Nielsen
    Marius Henriksen
    Ian A. Harris
    Henning Bliddal
    Robin Christensen
    Trials, 22
  • [23] A review identified challenges distinguishing primary reports of randomized trials for meta-research: A proposal for improved reporting
    Nicholls, Stuart G.
    McDonald, Steve
    McKenzie, Joanne E.
    Carroll, Kelly
    Taljaard, Monica
    JOURNAL OF CLINICAL EPIDEMIOLOGY, 2022, 145 : 121 - 125
  • [24] Placebo response and effect in randomized clinical trials: meta-research with focus on contextual effects
    Haflidadottir, Sigurlaug H.
    Juhl, Carsten B.
    Nielsen, Sabrina M.
    Henriksen, Marius
    Harris, Ian A.
    Bliddal, Henning
    Christensen, Robin
    TRIALS, 2021, 22 (01)
  • [25] The interpretation of clinical relevance in randomised clinical trials in patients with chronic low back pain: protocol for a meta-research study
    Innocenti, Tiziano
    Schleimer, Tim
    Salvioli, Stefano
    Giagio, Silvia
    Ostelo, Raymond
    Chiarotto, Alessandro
    METHODSX, 2023, 10
  • [26] The endorsement of general and artificial intelligence reporting guidelines in radiological journals: a meta-research study
    Zhong, Jingyu
    Xing, Yue
    Lu, Junjie
    Zhang, Guangcheng
    Mao, Shiqi
    Chen, Haoda
    Yin, Qian
    Cen, Qingqing
    Jiang, Run
    Hu, Yangfan
    Ding, Defang
    Ge, Xiang
    Zhang, Huan
    Yao, Weiwu
    BMC MEDICAL RESEARCH METHODOLOGY, 2023, 23 (01)
  • [27] The endorsement of general and artificial intelligence reporting guidelines in radiological journals: a meta-research study
    Jingyu Zhong
    Yue Xing
    Junjie Lu
    Guangcheng Zhang
    Shiqi Mao
    Haoda Chen
    Qian Yin
    Qingqing Cen
    Run Jiang
    Yangfan Hu
    Defang Ding
    Xiang Ge
    Huan Zhang
    Weiwu Yao
    BMC Medical Research Methodology, 23
  • [28] Methods and results of studies on reporting guideline adherence are poorly reported: a meta-research study
    Dal Santo, Tiffany
    Rice, Danielle B.
    Amiri, Lara S. N.
    Tasleem, Amina
    Li, Kexin
    Boruff, Jill T.
    Geoffroy, Marie-Claude
    Benedetti, Andrea
    Thombs, Brett D.
    JOURNAL OF CLINICAL EPIDEMIOLOGY, 2023, 159 : 225 - 234
  • [29] Completeness of reporting for systematic reviews of point-of-care ultrasound: a meta-research study
    Prager, Ross
    Pratte, Michael
    Guy, Andrew
    Bala, Sudarshan
    Bachar, Roudi
    Kim, Daniel J.
    Millington, Scott
    Salameh, Jean-Paul
    McGrath, Trevor A.
    McInnes, Matthew D. F.
    BMJ EVIDENCE-BASED MEDICINE, 2021, 26 (04) : 185 - 186
  • [30] Meta-Research on Oncology Trials: A Toolkit for Researchers with Limited Resources
    Riechelmann, Rachel P.
    Peron, Julien
    Seruga, Rostjan
    Saad, Everardo D.
    ONCOLOGIST, 2018, 23 (12): : 1467 - 1473