1 Stenehjem JS, et al. BMJ Open 2021;11:e046954. doi:10.1136/bmjopen-2020-046954 Open access Injury Prevention and long-term Outcomes following Trauma—the IPOT project: a protocol for prospective nationwide registry-based studies in Norway Jo Steinson Stenehjem , 1,2,3 Olav Røise , 4,5,6 Trond Nordseth, 1,7,8 Thomas Clausen, 9 Bård Natvig, 10 Svetlana O Skurtveit, 9,11 Torsten Eken , 6,12 Thomas Kristiansen, 6,12 Jon Michael Gran, 2 Leiv Arne Rosseland 1,6 To cite: Stenehjem JS, Røise O, Nordseth T, et al. Injury Prevention and long- term Outcomes following Trauma—the IPOT project: a protocol for prospective nationwide registry-based studies in Norway. BMJ Open 2021;11:e046954. doi:10.1136/ bmjopen-2020-046954 ► Prepublication history and additional supplemental material for this paper are available online. To view these fles, please visit the journal online (http://dx.doi.org/10.1136/ bmjopen-2020-046954). Received 13 November 2020 Revised 04 May 2021 Accepted 06 May 2021 For numbered affliations see end of article. Correspondence to Dr Jo Steinson Stenehjem; jo.stenehjem@kreftregisteret.no Protocol © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. ABSTRACT Introduction Traumatic injuries constitute a major cause of mortality and morbidity. Still, the public health burden of trauma in Norway has not been characterised using nationwide registry data. More knowledge is warranted on trauma risk factors and the long-term outcomes following trauma. The Injury Prevention and long-term Outcomes following Trauma project will establish a comprehensive research database. The Norwegian National Trauma Registry (NTR) will be merged with several data sources to pursue the following three main research topics: (1) the public health burden of trauma to society (eg, excess mortality and disability-adjusted life-years (DALYs)), (2) trauma aetiology (eg, socioeconomic factors, comorbidity and drug use) and (3) trauma survivorship (eg, survival, drug use, use of welfare benefts, work ability, education and income). Methods and analysis The NTR (n≈27 000 trauma patients, 2015–2018) will be coupled with the data from Statistics Norway, the Norwegian Patient Registry, the Cause of Death Registry, the Registry of Primary Health Care and the Norwegian Prescription Database. To quantify the public health burden, DALYs will be calculated from the NTR. To address trauma aetiology, we will conduct nested case–control studies with 10 trauma-free controls (drawn from the National Population Register) matched to each trauma case on birth year, sex and index date. Conditional logistic regression models will be used to estimate trauma risk according to relevant exposures. To address trauma survivorship, we will use cohort and matched cohort designs and time-to-event analyses to examine various post-trauma outcomes. Ethics and dissemination The project is approved by the Regional Committee for Medical Research Ethics. The project’s data protection impact assessment is approved by the data protection offcer. Results will be disseminated to patients, in peer-reviewed journals, at conferences and in the media. INTRODUCTION Rationale for the study and scientifc evidence gaps The high volume of disability and symptoms after accidental trauma represent a significant burden and costs to individuals and society. 1 Accounting for a total of 57.2 million years lived with disability on a global scale in 2017, 1 traumatic injuries constitute one of the major causes of mortality and morbidity in our society. Still, the public health burden of trauma in terms of descriptive statistics of trauma incidence rates, excess mortality from other causes of death than trauma and disability-adjusted life-years (DALYs) have not been well characterised by the use of national trauma registry data. 2 The DALY measure was developed in the Global Burden of Disease project, 3 4 and describes the gap between the current disease/injury situation and an ideal situation where lives are lived without the disease/injury in question. Although many injuries are preventable and some effective prophylactic strategies have been established, the potential for Strengths and limitations of this study ► Linkage of independent, national registries and data sources by use of a unique personal identifcation number for a comprehensive research database and complete control of loss to follow-up. ► Data from a number of nationwide registries enable a wide range of research questions within three main thematic areas: (1) public health burden, (2) aetiology and (3) survivorship. ► Approximately 27 000 trauma cases from a high- quality population-based trauma registry relying on mandatory reporting of incident trauma. ► Limited follow-up period (2015–2020) will hamper the analysis of some long-term outcomes, although a future extended follow-up has been planned. ► No blood samples, precluding the examination of molecular hypotheses. on February 24, 2022 by guest. 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