{
  "abstract": "Prognostic research is clinically relevant and ultimately facilitates stratified medicine. However, its quality and output are limited. More guidance is needed to improve understanding and thus quality. On behalf of the topic group ‘TG5: study design’ of the STRATOS initiative and for the general readership, this article describes key concepts and issues for prognostic factor studies, a sub-area of prognosis research. After providing a general overview on prognosis research, the article covers aspects such as aims, estimands and designs of prognostic factor studies, highlighting standards and current practice. Focusing on prognostic factor studies that assess a single factor at a time and a binary outcome, this article is complemented by a glossary of terms and a list of general aspects to consider in prognostic factor studies.",
  "authors": [
    {
      "affiliations": [
        "Institute of Genetic Epidemiology, Faculty of Medicine and Medical Center - University of Freiburg, Freiburg, Germany"
      ],
      "name": "Peggy Sekula"
    },
    {
      "affiliations": [
        "Institute of Genetic Epidemiology, Faculty of Medicine and Medical Center - University of Freiburg, Freiburg, Germany"
      ],
      "name": "Inga Steinbrenner"
    },
    {
      "affiliations": [
        "Institute of Genetic Epidemiology, Faculty of Medicine and Medical Center - University of Freiburg, Freiburg, Germany",
        "Department of Medicine IV - Nephrology and Primary Care, Faculty of Medicine and Medical Center - University of Freiburg, Freiburg, Germany",
        "Synlab MVZ Humangenetik Freiburg GmbH, Freiburg, Germany"
      ],
      "name": "Ulla T Schultheiss"
    },
    {
      "affiliations": [
        "Real World Evidence, TFS HealthScience, Barcelona, Spain"
      ],
      "name": "Neus Valveny"
    },
    {
      "affiliations": [
        "Bicocca Bioinformatics, Biostatistics and Bioimaging Centre - B4, School of Medicine and Surgery, University of Milan-Bicocca, Milano, Italy",
        "Unit of Clinical Epidemiology and Biostatistics, IRCCS San Gerardo dei Tintori Foundation, Monza, Lombardia, Italy"
      ],
      "name": "Paola Rebora"
    },
    {
      "affiliations": [
        "Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina, USA"
      ],
      "name": "Susan Halabi"
    },
    {
      "affiliations": [
        "Leslie Dan Faculty of Pharmacy & Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada"
      ],
      "name": "Suzanne M Cadarette"
    },
    {
      "affiliations": [
        "School of Health Sciences, College of Medicine and Health, University of Birmingham, Birmingham, UK",
        "National Institute for Health and Care Research (NIHR), Birmingham Biomedical Research Centre, Birmingham, UK"
      ],
      "name": "Richard D Riley"
    },
    {
      "affiliations": [
        "Centre for Statistics in Medicine, UK EQUATOR Centre, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, UK"
      ],
      "name": "Gary S Collins"
    },
    {
      "affiliations": [
        "Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center - University of Freiburg, Freiburg, Germany"
      ],
      "name": "Willi Sauerbrei"
    },
    {
      "affiliations": [
        "Biostatistics Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland, USA"
      ],
      "name": "Mitchell H Gail"
    },
    {
      "affiliations": [],
      "name": "for topic group 5 of the STRATOS initiative"
    }
  ],
  "title": "Design aspects for prognostic factor studies",
  "uid": "2e9a6740-c97f-5f31-b96f-e221044336f7"
}