Investigating the impact of problematic evidence on clinical practice guidelines and associated patient outcomes (VITALITY Study II): protocol
Year: 2026
Type: article
Abstract: INTRODUCTION: Increasing publication of fraudulent clinical trials poses a serious threat to evidence-based medicine. In the VITALITY Study I, we demonstrated that contamination by retracted trials significantly distorts evidence synthesis. The upcoming VITALITY Study II will take a step further and investigate how such problematic evidence undermines the credibility of guideline recommendations. METHODS AND ANALYSES: The VITALITY Study II will adopt a retrospective cohort design and will be structured as three work packages (WPs). To start with, a cohort of clinical practice guidelines (CPGs) that were contaminated by retracted trials and/or meta-analyses that included retracted trials will be established based on forward citation searching (WP1). Then, recommendations from these CPGs that used evidence from retracted trials and/or meta-analyses that synthesised these retracted trials will be re-evaluated after removing such problematic evidence, in terms of both the direction and strength of effect sizes (WP2). Finally, the subsequent impact on patient outcomes attributable to distorted recommendations will be estimated on a hypothetical population, measured by the number of expected benefit loss and the number of expected harm increment per 100 000 patients (WP3). ETHICS AND DISSEMINATION: Formal ethical approval is not necessary for this study as it does not involve human or animal participants, nor does it involve the collection of primary data. We will disseminate the findings through publication in peer-reviewed journals and, whenever possible, presentations at academic conferences.
Source: BMJ Open
Authors: Chang Xu, Luis Furuya Kanamori, Hong Cao, Xinyi Wang, Yoon K Loke, Sheyu Li, Tianmeng Wen, Shiqi Fan, Zhichun Gu, Jennifer C Stone, Lifeng Lin, Zuhaer Yisha, Ioana Alina Cristea, Liang Du, Justin Clark, Zongshi Qin, Yang Song, Linan Zeng, Zhaohu Fan, Su Golder, Haitao Chu, M Hassan Murad, Houwen Lin, Ben W Mol, Sunita Vohra, Suhail A Doi
Institutions: Second Military Medical University, The University of Queensland, Huazhong University of Science and Technology, Sichuan University, West China Hospital of Sichuan University, University of East Anglia, Peking Union Medical College Hospital, Shanghai Jiao Tong University, Renji Hospital, The University of Adelaide, University of Arizona, Peking University, University of Padua, Bond University, Chinese University of Hong Kong, Chinese University of Hong Kong, Shenzhen, West China Second University Hospital of Sichuan University, Georgia Institute of Technology, University of York, University of Minnesota, Mayo Clinic, Monash University, University of Alberta, Qatar University
Language: English
Subfield: Statistics, Probability and Uncertainty
Field: Decision Sciences
Domain: Social Sciences
Open Access status: gold
Estimated APC paid: $1,839
Awards: G2252856093, G5219859092, G5327247312
OpenAlex ID: W7147562107