Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford

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New guidelines for reporting of clinical research to improve medical decision-making

New guidelinesaiming to improve tools used by doctors in making diagnoses and treatment decisions are published today in the Annals of Internal Medicine and 10 other journals.

The TRIPOD guidelines were developed by a consortium of international investigators, led by researchers from the University of Oxford and the University Medical Center (UMC) Utrecht in the Netherlands, alongside health care professionals and journal editors. TRIPOD stands for Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis.

Clinical prediction models guide medical practitioners and patients through diagnostic and treatment decision-making. Such models are in fact tools to convert multiple pieces of information from a patient or individual into a probability that a specific condition is present or may occur in the future. The research that has led to these prediction models is generally reported in the medical literature. For medical practitioners to make accurate predictions and informed decisions, it is highly important that such research is transparently reported in medical journals.

The TRIPOD guideline aims to enhance this transparent reporting. It consists of a checklist of 22 itemsfor reporting research on so-called prediction models which aim to help clinical decision-making. The checklist is designed to allow researchers, peer reviewers and journal editors make sure a set of minimum criteria are included a published article.

Gary Collins, Associate Professor at the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences at Oxford University and lead researcher in TRIPOD, says: “We know clinical prediction models are being developed and used in all areas of medicine, with an ever increasing number being recommended in clinical guidelines. These models are being used to support clinical judgment. For example, NICE guidance recommends that people with a 10-year risk of developing cardiovascular disease in excess of 10% should be prioritised to be prescribed statins and/or blood pressure lowering drugs- this estimation of risk is done using a prediction model. It is therefore crucial that before using one of these models on individuals or patients, all aspects of the studies describing these models are accurate, complete and transparent so thatmethodological rigour, accuracy and applicability can be examined. We hope that journals will rapidly adopt and endorse the TRIPOD Statement.”

Karel Moons, Professor of Clinical Epidemiology of the Julius Center for Health Sciences and Primary Care, UMC Utrecht, The Netherlands, adds: “The past decades we have seen a wild growth in clinical prediction models, across the entire medical field. But the scientific evidence whether these models are accurate enough to use them in our patients is in the vast majority lacking and certainly unclear reported. This should change quickly: besides that these models are often recommended in clinical guidelines as Gary says, it worries me even more that they show up almost daily on websites and in medical apps. Everyone can thus use these prediction models to ‘quickly’ calculate their risk of having or developing, for example, a osteoporosis, diabetes, colon cancer, heart failure, or depression. We have no clue whether the underlying models were correctly developed let alone properly tested. When researchers, editors and guideline developers take notice and ideally follow our guideline, it will become transparent for health care professionals, patients and other users, to judge whether published prediction models are indeed accurate, useful and trustworthy. It will separate the chaff (bad models) from the wheat(good models). Moreover, comprehensive and honest reporting facilitates others to check what was done, confirm or falsify the study results, and to detect misconduct”.

Currently, the quality of reporting of prediction model studies in medicine is generally poor, across different disease areas and different journals, as shown by anumber of scientific reviews. Poor reporting ultimately leads to weak prediction models that are not or should not be widely implemented or used in clinical practice.

The TRIPOD researchers intend theirStatement to change the landscape of clinical research reporting – and therefore research design – in the coming years.This will ultimately lead to better health care by improving the clinical prediction models used and their uptake by medical practitioners, say the researchers.TRIPOD will also helpother scientists understand what has been done, provide sufficient information for others to replicate the study, identify scientific misconduct, and improve accountability.

To encourage dissemination of the TRIPOD Statement, the article is also published in BJOG: An International Journal of Obstetrics & Gynaecology, British Journal of Cancer, British Journal of Surgery, BMC Medicine, British Medical Journal, Circulation, Diabetic Medicine, European Journal of Clinical Investigation, European Urology, and Journal of Clinical Epidemiology.

The Oxford University and UMC Utrecht researchers have previously been involved in developing similar reporting guidelines for clinical trials,observational studies, systematic reviews, animal research and diagnostic test research, called CONSORT, STROBE, PRISMA, ARRIVE and STARD, respectively. These guidelines are changing the quality of research reporting found in the literature.

The TRIPOD guidelines are also part of the EQUATOR Network, an international initiative that seeks to improve the reliability and value of published health research literature by promoting transparent and accurate reporting and wider use of robust reporting guidelines.

“The EQUATOR Network’s online platform provides easy access to all guidelines and other resources supporting scientists in responsible publication of their research. The TRIPOD guidelines are a valuable addition to our collection”, says IvetaSimera, Head of Programme Development for the EQUATOR Network. “Following reporting guidelines when writing research manuscripts is a simple, cost effective solution for improving completeness, accuracy and usability of medical research papers. In the current financial climate it is unjustifiable not to implement something so simple that can substantially improve the quality of research output and increase its benefits to patients.”

You can keep up-to-date on TRIPOD news on their website and via twitter @TRIPODStatement.

ENDS

For more information please contact the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences Communications office on +44 (0)1865 737649 or , or the Julius Center for Health Sciences and Primary Care, UMC Utrecht, The Netherlands +31 88 7559368.

Notes to editors

  • TRIPOD publications:
    Collins GS, Reitsma JB, Altman DG, Moons KG. Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis: The TRIPOD Statement. Annals of Internal Medicine 2015; 162: 55-63.
    Moons KGM, Altman DG, Reitsma JB, Ioannidis JPA, Macaskill P, Steyerberg EW, Vickers AJ, Ransohoff DF, Collins GS. Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD): Explanation and Elaboration. Ann intern Med 2015; 162: W1-W73.
  • The Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS) is a multi-disciplinary department focusing on musculoskeletal diseases, from bench to bedside. The academic department is part of the Medical Sciences Division of the University of Oxford, and is a rapidly growing community of more than 350 orthopaedic surgeons, rheumatologists and scientists all working in the field of musculoskeletal disorders.
    The research work of the department takes place in several locations across the Nuffield Orthopaedic Centre, namely the Botnar Research Centre and the Kennedy Institute of Rheumatology. The co-location with NHS services puts the department in an excellent position with basic researchers working alongside clinicians. This substantially improves research capacity, improving access for researchers to patients, and facilitating the interaction between clinicians and basic scientists that is essential for successful medical research.
  • Oxford University’s Medical Sciences Division is one of the largest biomedical research centres in Europe, with over 2,500 people involved in research and more than 2,800 students. The University is rated the best in the world for medicine, and it is home to the UK’s top-ranked medical school.
    From the genetic and molecular basis of disease to the latest advances in neuroscience, Oxford is at the forefront of medical research. It has one of the largest clinical trial portfolios in the UK and great expertise in taking discoveries from the lab into the clinic. Partnerships with the local NHS Trusts enable patients to benefit from close links between medical research and healthcare delivery.
    A great strength of Oxford medicine is its long-standing network of clinical research units in Asia and Africa, enabling world-leading research on the most pressing global health challenges such as malaria, TB, HIV/AIDS and flu. Oxford is also renowned for its large-scale studies which examine the role of factors such as smoking, alcohol and diet on cancer, heart disease and other conditions.
  • The Julius Center for Health Sciences and Primary care is part of the University Medical Center Utrecht (UMC Utrecht). The UMC Utrecht belongs to the largest public healthcare institution in the Netherlands. It was created in 2000 through the merger of Utrecht Academic Hospital, Wilhelmina Children’s Hospital and the Medical Faculty of Utrecht University. UMC Utrecht has the ambition to be a leading international healthcare provider, medical school and research institute that is exciting for its people, attractive to talent and embodies a culture of teamwork, innovation, sustainability and high performance. As a patient-centered organization, its 11,000 employees are dedicated to prevent disease, improve healthcare, develop new treatment methods and refine existing ones, with patient safety and quality as cornerstones. Strategic research programs are Brain, Child Health, Circulatory Health, Infection & Immunity, Personalized Cancer Care and Regenerative Medicine & Stem Cells. UMC Utrecht is embedded in a vibrant and entrepreneurial science community where knowledge about health, disease and healthcare is generated, validated, shared and applied. For more information, visit follow us on Twitter @UMCU_INTL; phone: +31 88 7555 50 00; email: