Methodological rigour in preclinical urology: a systematic review reporting research quality over a 14-year period.

Journal: BJU international

Volume: 133

Issue: 4

Year of Publication: 2024

Affiliated Institutions:  Yonsei University College of Medicine, Seoul, South Korea. Ulsan University College of Medicine, Seoul, South Korea. Evidence-Based Research Laboratory, Department of Clinical Pharmacy and Pharmaceutical Care, College of Pharmacy, Chung-Ang University, Seoul, South Korea. Italian Agency for Development Cooperation, Khartoum, Sudan. Centre for Health Performance and Wellbeing, Anglia Ruskin University, Cambridge, UK. School of Life Sciences, Faculty of Science and Engineering, Anglia Ruskin University, Cambridge, UK. Research and Development Unit, Parc Sanitari Sant Joan de Déu, Universitat de Barcelona, Fundació Sant Joan de Déu, CIBERSAM, Barcelona, Spain. Department of Geriatric Medicine, Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey. Department of Internal Medicine, University of Palermo, Geriatrics Section, Palermo, Italy. Urology Department, Hull University Teaching Hospitals, Hull, UK. Urology Institute, University Hospitals System, Case Western Reserve University School of Medicine, OH, Cleveland, USA. Department of Urology, Tel-Aviv Sourasky Medical Center, Sackler School of Medicine, Tel-Aviv University, Tel Aviv-Yafo, Israel. Norfolk and Norwich University Hospital, Norwich, UK. Sungkyunkwan University School of Medicine, Suwon, South Korea. Center for Digital Health, Medical Science Research Institute, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, Seoul, South Korea. Department of Urology, Yonsei University College of Medicine, Seoul, South Korea. Department of Pediatrics, Yonsei University College of Medicine, Seoul, South Korea. Urology Institute University Hospitals Cleveland Medical Center, Case Western Reserve University School of Medicine, Cleveland, OH, USA.

Abstract summary 

To investigate the prevalence and trends of essential study design elements in preclinical urological studies, as well as key factors that may improve methodological rigour, as the demand for methodological rigour in preclinical studies is increasing since research reproducibility and transparency in the medico-scientific field are being questioned.PubMed was searched to include preclinical urological studies published between July 2007 to June 2021. A total of 3768 articles met the 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. Randomisation 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 randomisation and statistical analysis.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 (randomisation, blinding, sample size estimation, statistical analysis, and housing and husbandry) proposed by both the National Institutes of Health and Animal Research: Reporting of In Vivo Experiments guidelines have been either well reported or are being well reported over time.PROSPERO CRD42022233125.

Authors & Co-authors:  Park Seung Hyun SH Lee Se Bee SB Park Seoyeon S Kim Eun Young EY Pizzol Damiano D Trott Mike M Barnett Yvonne Y Koyanagi Ai A Jacob Louis L Soysal Pinar P Veronese Nicola N Ippoliti Simona S Abou Ghayda Ramy R Thirumavalavan Nannan N Hijaz Adonis A Sheyn David D Pope Rachel R Conroy Britt B Jaeger Irina I Shubham Gupta G Nevo Amihay A Ilie Petre Cristian PC Lee Seung Won SW Yon Dong Keon DK Han Hyun Ho HH Hong Sung Hwi SH Shin Jae Il JI Ponsky Lee L Smith Lee L

Study Outcome 

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Statistics
Citations :  Collier R. Rapidly rising clinical trial costs worry researchers. CMAJ 2009; 180: 277-278
Authors :  29
Identifiers
Doi : 10.1111/bju.16171
SSN : 1464-410X
Study Population
Male
Mesh Terms
Male
Other Terms
animal models;methodological rigour;preclinical studies;reproducibility of results;urological disease
Study Design
Study Approach
Country of Study
Publication Country
England