SUMMARY
Rationale: In the Netherlands, trauma-related injuries affect more than 700,000 people annually, and many require rehabilitation. Regardless of trauma-related injuries, over 500,000 individuals live in financial vulnerability, often characterized as having low socioeconomic status (SES). Patients with low SES have an increased risk of sustaining trauma and generally experience poorer recovery outcomes. Access to physical therapy care is limited for this population, despite the substantial impact of trauma on quality of life and daily functioning. Little is known about their long-term rehabilitation outcomes. This study aims to improve understanding of recovery patterns in patients with trauma-related injuries and explores whether outcomes differ between SES-groups.
Objective: The primary objective is to assess quality of life 1 week prior to the injury, and at 1 week, 6 weeks, 12 weeks, 6 months, and 1 year after trauma-related injury. Secondary objectives include evaluating social, physical and mental functioning, fatigue, pain, and return-to-work. Outcomes will be compared across socioeconomic groups to explore how financial vulnerability is associated with recovery.
Study design: Prospective, longitudinal cohort study. Study population: In total 185 patients (≥18 years) with trauma-related injuries (ISS ≥9) admitted to the Radboud University Medical Center will be included between April 2026 and October 2027.
Main study parameters/endpoints: The primary outcome is quality of life, measured using validated PROMIS® Global02 at all follow-up timepoints. Secondary outcomes include perceived health, social, physical, and mental functioning, fatigue, and pain, assessed using validated PROMIS® questionnaires at the same follow up moments. SES indicators (postal code, education level, type of employment), health insurance coverage, and work status will also be collected.
Nature and extent of the burden and risks associated with participation, benefit, and group relatedness: Participation involves minimal burden and no medical risks. Patients are asked to complete digital of paper questionnaires at predefined intervals with a burden of approximately 10 minutes per follow-up interval. No additional procedures or treatments are required. The participant will receive a compensation of €5 for each completed questionnaire. The study is expected to generate valuable insights that can improve quality, accessibility, and tailoring of physical therapy care for future trauma patients, particularly those in a financially vulnerable situation.
Adults ≥ 18 years
Trauma-related injury and an Injury Severity Score (ISS) ≥ 9 points
Admitted ≥ 24 hours to the Radboudumc
Delirium, dementia, or depression
Unable to participate in the informed consent procedure
Life expectancy < 3 months
The study population consists of patients 18 years or older with trauma-related injuries admitted to the Radboud University Medical Center (Radboudumc). In the Netherlands, 722,050 people experience trauma-related injuries each year \[1\]. In 2024, a total of 75,232 patients with injuries were registered in the National Trauma Registry (LRT) \[13\]. At the Radboud University Medical Center, we treated 508 severely injured patients in 2024 (Injury Severity Score (ISS) ≥16). Data for patients with an ISS between 9 and 15, treated at the Radboud University Medical Center, is not available.
Cohort
Prospective
Questionnaires
Other interventionPROMIS Questionnaires
Health-related quality of life measured by PROMIS® Global-02
Health-related quality of life is assessed using PROMIS® Global02. Participants rate their overall quality of life on a 5-point scale ranging from 1 (poor) to 5 (excellent). Higher scores indicate better health-related quality of life.
Perceived health measured by PROMIS® Global01
Perceived health is assessed using PROMIS® Global01. Participants rate their overall health on a 5-point scale ranging from 1 (poor) to 5 (excellent). Higher scores indicate better perceived health.
Social functioning measured by PROMIS® Ability to Participate in Social Roles and Activities Short Form 4a
Social functioning is assessed using the PROMIS® Ability to Participate in Social Roles and Activities Short Form 4a. The questionnaire contains 4 items scored on 5-point response scales. Total scores range from 4 to 20. Higher scores indicate better social functioning and participation.
Physical functioning measured by PROMIS® Physical Function Short Form 8b
Physical functioning is assessed using the PROMIS® Physical Function Short Form 8b. The questionnaire contains 8 items scored on 5-point response scales. Total scores range from 8 to 40. Higher scores indicate better physical functioning.
Anxiety measured by PROMIS® Anxiety Short Form 4a
Anxiety is assessed using the PROMIS® Anxiety Short Form 4a. The questionnaire contains 4 items scored from 1 to 5. Total scores range from 4 to 20. Higher scores indicate greater anxiety symptoms.
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