Methodological Rigour in Preclinical Urology: a 14-year systematic review reporting research quality.
Por:
Park SH, Lee SB, Park S, Kim EY, Pizzol D, Trott M, Barnett Y, Koyanagi A, Jacob L., Soysal P, Veronese N, Ippoliti S, Abou Ghayda R, Thirumavalavan N, Hijaz A, Sheyn D, Pope R, Conroy B, Jaeger I, Shubham G, Nevo A, Ilie PC, Lee SW, Yon DK, Han HH, Hong SH, Shin JI, Ponsky L and Smith L
Publicada:
1 abr 2024
Ahead of Print:
4 sep 2023
Resumen:
BACKGROUND: The demand for methodological rigour in preclinical studies is increasing since the research reproducibility and transparency in the medico-scientific field are being questioned. As a result, we investigated the prevalence and the trends of essential study design elements in preclinical urological studies, as well as key factors which may improve methodological rigour. METHODS AND RESULTS: PubMed was searched to include preclinical urological studies published between July 2007 to June 2021. Total 3768 articles met inclusion criteria. Data on study design elements and animal models used were collected. Citation density was also examined as a surrogate marker of study influence. We performed an analysis of the prevalence of seven critical study design elements and temporal patterns over 14 years. Randomization was reported in 50.0%, blinding in 15.0%, sample size estimation in 1.0%, inclusion of both sexes in 6.3%, statistical analysis in 97.1%, housing and husbandry in 47.7%, and inclusion/exclusion criteria in 5.0%. Temporal analysis showed that the implementation of these study design elements has increased, except for inclusion of both sexes and inclusion/exclusion criteria. Reporting study design elements were associated with increased citation density in randomization, and statistical analysis. CONCLUSIONS: The risk of bias is prevalent in 14-year publications describing preclinical urological research, and the quality of methodological rigour is barely related to the citation density of the article. Yet five study design elements (randomization, blinding, sample size estimation, statistical analysis, housing, and husbandry) proposed by both NIH and ARRIVE guidelines have been either well reported or are being well reported over time.
Filiaciones:
Park SH:
Yonsei University College of Medicine, Seoul, Republic of Korea
Lee SB:
Ulsan University College of Medicine, Seoul, Republic of Korea
Park S:
Yonsei University College of Medicine, Seoul, Republic of Korea
Kim EY:
Evidence-Based Research Laboratory, Department of Clinical Pharmacy and Pharmaceutical Care, College of Pharmacy, Chung-Ang University, Seoul, South Korea
Department of Pharmaceutical Industry, ChungAng University, Seoul, South Korea
College of Pharmacy, Chung-Ang University, Seoul, South Korea
Pizzol D:
Italian Agency for Development Cooperation, Khartoum, Sudan
Trott M:
Centre for Health Performance and Wellbeing, Anglia Ruskin University, Cambridge, UK, CB1 1PT
Barnett Y:
School of Life Sciences, Faculty of Science and Engineering, Anglia Ruskin University, East Road, Cambridge, UK
Koyanagi A:
Research and Development Unit, Parc Sanitari Sant Joan de Déu, Universitat de Barcelona, Fundació Sant Joan de Déu, CIBERSAM, Barcelona, Spain
ICREA, Barcelona, Spain
Instituto de Salud Carlos III, Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Madrid, Spain
Jacob L.:
Research and Development Unit, Parc Sanitari Sant Joan de Déu, Universitat de Barcelona, Fundació Sant Joan de Déu, CIBERSAM, Barcelona, Spain
Instituto de Salud Carlos III, Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Madrid, Spain
Faculty of Medicine, University of Versailles Saint-Quentin-en-Yvelines, Montigny-le-Bretonneux, France
Soysal P:
Department of Geriatric Medicine, Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey
Veronese N:
Department of Internal Medicine, University of Palermo, Geriatrics Section, Palermo, Italy
Ippoliti S:
Urology department, Hull University Teaching Hospitals, Hull, United Kingdom
Abou Ghayda R:
Urology Institute, University Hospitals System, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA
Thirumavalavan N:
Urology Institute, University Hospitals System, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA
Hijaz A:
Urology Institute, University Hospitals System, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA
Sheyn D:
Urology Institute, University Hospitals System, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA
Pope R:
Urology Institute, University Hospitals System, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA
Conroy B:
Urology Institute, University Hospitals System, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA
Jaeger I:
Urology Institute, University Hospitals System, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA
Shubham G:
Urology Institute, University Hospitals System, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA
Nevo A:
Department of Urology, Tel-Aviv Sourasky Medical Center, Sackler School of Medicine, Tel-Aviv University, Tel Aviv-Yafo, Israel
Ilie PC:
Norfolk and Norwich University Hospital, Norwich, UK
Lee SW:
Sungkyunkwan University School of Medicine, Suwon, South Korea
Yon DK:
Center for Digital Health, Medical Science Research Institute, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, Seoul, South Korea
Han HH:
Department of Urology, Yonsei University College of Medicine, Seoul, Republic of Korea
Hong SH:
Yonsei University College of Medicine, Seoul, Republic of Korea
Shin JI:
Department of Pediatrics, Yonsei University College of Medicine, Seoul, Republic of Korea
Department of Medical Education, Yonsei University College of Medicine, Seoul, Republic of Korea
Center for Medical Education Training and Professional Development in Yonsei-Donggok Medical Education Institute, Yonsei University College of Medicine, Seoul, Republic of Korea
Ponsky L:
Urology Institute, University Hospitals System, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA
Smith L:
Centre for Health Performance and Wellbeing, Anglia Ruskin University, Cambridge, UK, CB1 1PT
Open Access
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