{
  "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.",
  "authors": [
    {
      "affiliations": [
        "Proof of Concept Center, Naval Medical University, Shanghai, China"
      ],
      "name": "Chang Xu"
    },
    {
      "affiliations": [
        "The University of Queensland, Saint Lucia, Queensland, Australia"
      ],
      "name": "Luis Furuya Kanamori"
    },
    {
      "affiliations": [
        "School of Pharmacy, Huazhong University of Science and Technology, Wuhan, China"
      ],
      "name": "Hong Cao"
    },
    {
      "affiliations": [
        "Chinese Evidence-Based Medicine Center (Cochrane China Center), West Hospital of Sichuan University, Chengdu, China"
      ],
      "name": "Xinyi Wang"
    },
    {
      "affiliations": [
        "Norwich Medical School, University of East Anglia, Norwich, UK"
      ],
      "name": "Yoon K Loke"
    },
    {
      "affiliations": [
        "West China Hospital of Sichuan University, Chengdu, China",
        "Department of Endocrinology and Metabolism, West China Hospital, Chengdu, People's Republic of China",
        "Division of Guideline and Rapid Recommendation, MAGIC China Centre, Chengdu, People's Republic of China"
      ],
      "name": "Sheyu Li"
    },
    {
      "affiliations": [
        "Epidemiology, Peking Union Medical College Hospital, Beijing, China"
      ],
      "name": "Tianmeng Wen"
    },
    {
      "affiliations": [
        "Proof of Concept Center, Naval Medical University, Shanghai, China"
      ],
      "name": "Shiqi Fan"
    },
    {
      "affiliations": [
        "Department of Pharmacy, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China"
      ],
      "name": "Zhichun Gu"
    },
    {
      "affiliations": [
        "The University of Adelaide, Adelaide, South Australia, Australia"
      ],
      "name": "Jennifer C Stone"
    },
    {
      "affiliations": [
        "Department of Epidemiology and Biostatistics, The University of Arizona Mel and Enid Zuckerman College of Public Health, Tucson, Arizona, USA"
      ],
      "name": "Lifeng Lin"
    },
    {
      "affiliations": [
        "Department of Epidemiology and Biostatistics, Peking University, Beijing, China"
      ],
      "name": "Zuhaer Yisha"
    },
    {
      "affiliations": [
        "Department of General Psychology, University of Padova, Italy, UK"
      ],
      "name": "Ioana Alina Cristea"
    },
    {
      "affiliations": [
        "Chinese Evidence-Based Medicine Center (Cochrane China Center), West Hospital of Sichuan University, Chengdu, China"
      ],
      "name": "Liang Du"
    },
    {
      "affiliations": [
        "Centre for Research in Evidence Based Practice, Bond University, Gold Coast, Queensland, Australia"
      ],
      "name": "Justin Clark"
    },
    {
      "affiliations": [
        "Clinical Research Institute, Institute of Advanced Clinical Medicine, Peking University, Beijing, People's Republic of China"
      ],
      "name": "Zongshi Qin"
    },
    {
      "affiliations": [
        "School of Medicine, Chinese University of Hong Kong, Shenzhen, China"
      ],
      "name": "Yang Song"
    },
    {
      "affiliations": [
        "Department of Pharmacy, Evidence-Based Pharmacy Centre, NMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation, Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University West China Second University Hospital, Chengdu, Sichuan, China"
      ],
      "name": "Linan Zeng"
    },
    {
      "affiliations": [
        "Scheller College of Business, Georgia Institute of Technology, Atlanta, Minnesota, USA"
      ],
      "name": "Zhaohu Fan"
    },
    {
      "affiliations": [
        "Department of Health Sciences, University of York, York, UK"
      ],
      "name": "Su Golder"
    },
    {
      "affiliations": [
        "Department of Biostatistics, University of Minnesota School of Public Health, Minneapolis, Minnesota, USA"
      ],
      "name": "Haitao Chu"
    },
    {
      "affiliations": [
        "Evidence-Based Practice Center, Mayo Clinic, Rochester, Minnesota, USA"
      ],
      "name": "M Hassan Murad"
    },
    {
      "affiliations": [
        "Department of Pharmacy, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China"
      ],
      "name": "Houwen Lin"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia"
      ],
      "name": "Ben W Mol"
    },
    {
      "affiliations": [
        "Department of Pediatrics and Department of Psychiatry, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, Alberta, Canada"
      ],
      "name": "Sunita Vohra"
    },
    {
      "affiliations": [
        "Department of Population Medicine, Qatar University, Doha, Qatar"
      ],
      "name": "Suhail A Doi"
    }
  ],
  "title": "Investigating the impact of problematic evidence on clinical practice guidelines and associated patient outcomes (VITALITY Study II): protocol",
  "uid": "0397059a-3844-526f-a2df-f5d3a4f4029b"
}