Viewing Study NCT06442332



Ignite Creation Date: 2024-06-16 @ 11:51 AM
Last Modification Date: 2024-10-26 @ 3:31 PM
Study NCT ID: NCT06442332
Status: COMPLETED
Last Update Posted: 2024-06-10
First Post: 2024-05-29

Brief Title: Long-term Consequences of Cyclist Injuries
Sponsor: Norwegian Institute of Public Health
Organization: Norwegian Institute of Public Health

Study Overview

Official Title: Recording Cyclist Crashes and Long-term Injury Consequences by New Smart Tools ReCyCLIST Work Package 4 Long-term Consequences of Cyclist Injuries
Status: COMPLETED
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: RECYCLIST WP4
Brief Summary: There is a lack of knowledge about the extent of bicycle injuries in Norway Among other things a significant underreporting of bicycle injuries has been found in the official road traffic accident statistics based on police-registered accidents Furthermore there is a lack of knowledge about the long-term consequences of serious bicycle injuries The main purpose of this project is to generate new knowledge about the consequences of bicycle injuries for later disability employment status and use of prescribed drugs In addition the investigators want to study whether such long-term consequences vary according to demographic and socioeconomic characteristics as well as to assess the degree of overlap between bicycle injuries registered in the official road traffic accident statistics and bicycle injuries registered in the health service including an assessment of the severity of the injury The investigators will use a retrospective analysis where a population-based dataset from the National Population Register is linked with information on injured cyclists from Statistics Norways database on police-reported road traffic accidents the Norwegian Patient Register the National Trauma Registry and the Norwegian Cause of Death Registry In order to study the long-term consequences of bicycle injuries the investigators will also compile information on social security benefits and employment from Statistics Norways historical events database FD-Trygd and the use of prescribed drugs from the Norwegian Prescribed Drug Registry The investigators will also collect information on income and educational attainment from registers in Statistics Norway The project will contribute to increased knowledge about the societal and individual burden of bicycle injuries knowledge that is crucial for prioritizing and implementing necessary preventive measures
Detailed Description: 1 Project organisation The research activity described in this protocol constitutes one work package of the research project ReCyCLIST Recording Cyclist Crashes and Long-term Injury Consequences by new Smart Tools The ReCyCLIST project is a collaboration between research institutes from the health and transport sciences public authorities medical expertise web-tool developers and end-user organisations The project is coordinated by the Institute of Transport Economics TØI with Torkel Bjørnskau as overall project manager Additional project partners in this work package include the National Institute of Public Health NIPH and the Norwegian Trauma Registry NTROslo University Hospital OUS

The project group in this work package which in the following will be referred to as the project consists of the following researchers
Torkel Bjørnskau TØI
Ingeborg Hesjevoll TØI
Rikke Ingebrigtsen TØI
Katrine Karlsen TØI
Eyvind Ohm NIPH - project leader
Christian Madsen NIPH
Elling Tufte Bere NIPH
Yusman Bin Kamaleri NIPH
Svetlana Skurtveit NIPH
Olav Røise NTROUS
2 Study objectives

This project has three primary objectives

1 To assess the degree of overlap of cyclist injuries registered in the official road accident statistics and in the health services and thereby map the level of underreporting of cyclist injuries in the former data source
2 To obtain knowledge of long-term consequences of cyclist injuries with respect to

1 Disability
2 Employment status
3 Use of prescribed drugs
3 To examine whether such long-term consequences vary by sociodemographic characteristics

3 Methodology 31 STUDY DESIGN To address these issues the investigators aim to construct a population-based dataset containing census data including sociodemographic information from the National Population Register for all individuals residing in Norway in the period 2008-2021 This dataset is to be linked with information on injuries registered in four data sources 1 Statistics Norways SSB database on police-reported road traffic accidents 2 the National Patient Registry NPR 3 the Norwegian Trauma Registry NTR and 4 the Norwegian Cause of Death Registry DÅR To analyse long-term consequences of cyclist injuries with respect to disability employment status and use of prescribed drugs the investigators will further link data for adults aged 18-67 years from SSBs historical events database FD-Trygd and the Norwegian Prescribed Drug Registry Finally to examine socioeconomic differences in risk of such long-term consequences the investigators will link data on educational attainment and income both supplied by SSB

The overall population-based design of the study was chosen to enhance the validity of the estimates and to facilitate the interpretation of the statistical analyses For instance when assessing long-term consequences of cyclist injuries and how these vary by sociodemographic characteristics it is paramount to collect this type of information also for individuals that have not been involved in bicycle crashes By including the whole population the investigators will generate a more powerful comparison group than other potential designs and reduce potential sources of bias Moreover this design will allow for more robust estimates of incidence rates and risk factors for the outcome variables by including valid estimates of person-time at risk To control for the occurrence of non-cycle injuries that may influence functional outcomes the investigators will also collect information on other types of injuries both for injured cyclists and for the population at large

32 DESCRIPTION OF DATA SOURCES

1 The National Population Register Census data for all residents of Norway in the period 2008-2021 including the following information

Month and year of birth
Sex
Immigrant status and country of origin
Marital status
Residential code - classification of individuals as resident emigrated or dead with month and year for change of code
Municipality of residence
Encrypted ID number for individual-level linkage with other registers
2 Police-reported road traffic accidents Information about all road traffic accidents reported to the police in the period 2008-2021 including the following variables

Date of crash
Municipality and location of crash X- and Y coordinates
Road category European route national road county road etc
Type of road highway pedestrian zone walkingcycling path etc
Speed limit
Accident type single accident rear-end collision head-on collision etc
Type of vehicle passenger car heavy goods vehicle bicycle motorcycle bus etc
Classification of road user driverpassenger of car riderpassenger of motorcyclemopedbicycle pedestrian etc
Age and sex of injured person
Injury severity killed very seriously injured seriously injured slightly injured unspecified
Suspicion of alcohol intoxication
Protective equipment seat belt helmet use
Counterpart in collision motor vehicle lightheavy bicycle pedestrian etc
3 National Patient Registry Information about all injury contacts in secondary care registered in NPR in the period 2008-2021 identified by diagnostic codes from chapter XIX and chapter XX of the tenth edition of the International Statistical Classification of Diseases and Health Related Problems ICD-10 For these patients the investigators will include the following information

Date of treatment
Place of treatment hospital ID
Injury diagnoses principal and secondary

In addition injury data for all patients registered in the common minimum dataset for personal injury FMDS will be included This dataset contains information about the external circumstances of injuries treated in secondary care including the following variables
Date and time of injury
Intent accident self-harm assault
Place of occurrence roadstreet residence workplace playground etc
Type of transport vehicle
Activity sportleisure work education etc
Injury mechanism
Injury severity
Municipality where injury occurred
Location of road traffic crash X- and Y-coordinates
4 Norwegian Trauma Registry Since 2015 NTR contains nationwide data on patients admitted to hospital with potentially severe injury ie high- and low energy trauma patients From this register the investigators aim to use information about all injured patients admitted to trauma-receiving hospitals in the period 2015-2021 including the following variables

Date and time of injury
Municipality where injury occurred
ASA score before injury a measure of physiological statuscomorbidity developed by the American Society of Anesthesiologists to predict operative risk
Glasgow Outcome Scale measure of functional status before injury and at discharge from hospital
Helmet use
Intent
Injury mechanism
Type of traffic accident
Sport and leisure accident
Dead on arrival
Days of hospital stay
Dead within 30 days of injury
Abbreviated Injury Scale AIS
Injury Severity Scale ISS
New Injury Severity Scale NISS
5 The Cause of Death Registry Information about all fatal injuries registered in the period 2008-2021 identified by diagnostic codes from chapter XX of ICD-10 as underlying cause of death including the following variables

Month and year of death
Resident in Norway at time of death
Age in years
Municipality of residence
Country of death
Municipality where death occurred
Special circumstances
Place where injury occurred
Activity related to injury
Underlying cause of death chapter XX
Main injury codes from chapter XIX
Contributing causes of death
6 FD-Trygd FD-Trygd is Statistics Norways historical events database which links basic demographic data with employment records and information about services and benefits administered by the Norwegian Labour and Welfare Administration NAV The investigators aim to use the following variables from this database

Sickness benefit
Work assessment allowance
Disability benefit
Old age pension and early retirement pension
Basic benefit and attendance benefit
Employment including occupation
Job seeker status
7 The Norwegian Prescribed Drug Registry Information on analgesics and other psychopharmaceutical drugs dispensed from pharmacies to individual patients living outside institutions in the period 2008-2021 including the following variables

Prescribers project ID
Prescribers profession and specialty
Patients sex and yearmonth of birth
Patients residential municipality
Dispensing number
Dispensing date
Number of packages per filled prescription
Number of DDDs defined daily dose per filled prescription
Regulation legal basis
Reimbursement Code
Reimbursement Code ICD
Reimbursement Code ICPC
Article number unique product identifier
ATC Anatomical Therapeutic Chemical code at 5th level for all N codes anatomical main group nervous system apart from N04 anti-Parkinson drugs plus codes M01A anti-inflammatory and antirheumatic products non-steroids M02A topical products for joint and muscular pain M03BA muscle relaxants peripherally acting agents and H02A corticosteroids for systemic use plain
Prescription category narcotic drug other addictive drug prescription drug
8 The National Education Database NUDB From this database the investigators will include information about highest educational attainment coded according to the Norwegian Standard Classification of Education and the year this level was achieved The database is administered by Statistics Norway
9 Statistics Norways income database Statistics Norway collects income data by linking different administrative registers and statistical data sources including tax returns From this database the investigators will include the following variables

Pensionable income

Total income

Household income

Taxable gross wealth

33 STATISTICAL ANALYSIS To map the degree of overlap of cyclist injuries between health registers NPR NTR and DÅR and the official road traffic accident statistics the investigators will compare the number and characteristics of such injuries in total and in different sub-populations registered in these four data sources To obtain knowledge of long-term consequences of cyclist injuries the investigators will perform descriptive analyses to examine disability rates employment status and use of prescription drugs The investigators will further use Poisson regression to model incidence rates with respect to various injury-related factors injury severity type of accident injury mechanism helmet use etc and to examine the degree to which these long-term consequences vary by sex age and other sociodemographic variables

34 REQUIRED PERMISSIONS

The project will require permissions from
The Regional Committees for Medical and Health Research Ethics REC for advance ethical approval
Statistics Norway SSB for access to microdata from the National Population Register the police-reported road accident database FD-Trygd and socioeconomic data including data from NUDB
The Norwegian Directorate of Health for access to injury data in NPR
Oslo University Hospital OUS for access to trauma data in NTR
The Norwegian Institute of Public Health NIPH for approval of Data Protection Impact Assessment DPIA and for access to data in DÅR and the Norwegian Prescribed Drug Registry

35 PROCEDURE FOR DATA LINKAGE Statistics Norway will define the study population as described in paragraph 41 and generate project-specific ID numbers with linkage to the unique personal ID numbers given to all Norwegian residents Statistics Norway will then link data from the National Population Register the police-reported road accident database FD-Trygd and sociodemographic data according to specifications described in paragraph 42 Likewise the Norwegian Directorate of Health NTR and NIPH will link their respective data After linkage each data owner will send these datasets in which the unique personal ID number is deleted and replaced by the project-specific ID number to the project The Norwegian Directorate of Health NTR and NIPH will subsequently delete the file linking the personal ID numbers and project-specific ID numbers which will for the duration of the project be stored securely by Statistics Norway

4 Significance and ethical aspects The study will improve our understanding of the societal and individual burden of bicycle injuries and provide new knowledge of their long-term consequences Exploring sociodemographic risk factors will further guide policy makers in identifying effective safety measures

The project will follow ethical guidelines for statistical analysis and presentation of results considering both privacy issues and statistical robustness A potential risk involves identification of individuals However the files received by the project contain no directly identifiable information as unique personal ID numbers are replaced by project-specific ID numbers To minimise the risk of backwards identification analyses will be performed on files containing only the variables needed to address the different research questions For instance to assess the degree of overlap between injured cyclists in health registries and the official road traffic accident database analyses will be restricted to variables common to these data sources thus omitting information on welfare benefits use of prescription drugs and socioeconomic variables Level of detail will also be reduced for instance by categorising age into 5-year age groups In addition analyses of long-term consequences of bicycle injuries including sociodemographic differences in such consequences will be restricted to adults aged 18-67 years

Another potential risk is stigma attached to specific groups of individuals for instance those receiving welfare benefits However this project will not present detailed information about such groups All results will be presented on aggregate level and results based on few observations 6 individuals will not be presented or discussed

The project will include sensitive information about individuals eg medical diagnoses use of prescription drugs receipt of welfare benefits and measures of comorbidityfunctional status However the investigators will not collect any new data but utilise data already registered in other data sources The use of these data is regulated by law To ensure secure storing of data the investigators will use Services for sensitive data TSD which is a service where users can collect store share and analyse data within a secure environment with a high degree of safety

5 Project timeline

The project will be developed in tasks with the following timeline

Task 1 Preparation and linkage of registers January 2022 - February 2023

Task 2 Main data analysis February 2023 - May 2023

Task 3 Estimation of overlap between different registries March 2023 - June 2023

Task 4 Dissemination by December 2026

6 Funding The ReCyCLIST project is funded by the Research Council of Norway NFR and Agder County

7 Dissemination A designated ReCyCLIST project website httpswwwtoinorecyclist will be used for regular communication of project updates and results

For this specific work package the investigators plan to submit three focused articles to peer-reviewed international journals for open access publication

In addition results from this project will be presented at national and international seminars and conferences Nationally the most relevant will be the yearly conferences arranged by the Norwegian Public Roads Administration the Norwegian Safety Forum and the Norwegian Council for Road Safety Trygg Trafikk Internationally relevant conferences include the biannual Safe Communities Conference the annual International Cycling Safety Conference and the biannual Transportation Research Arena

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
326767 OTHER_GRANT The Research Council of Norway None