Long-term results of major trauma in Taiwan
| ISRCTN | ISRCTN18269986 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18269986 |
- Submission date
- 02/12/2023
- Registration date
- 07/12/2023
- Last edited
- 07/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
The long-term result of major trauma is mostly unknown until the present day. The traditional trimodal distribution of deaths was first described in 1982, implying that death due to injury occurs in three peaks. The first peak occurs within seconds to minutes of injury, the second peak occurs within minutes to several hours following injury, and the third peak occurs several days to weeks after the initial injury. However, research regarding the long-term results is scarce. The aim of this study is to better define the long-term outcome of major trauma patients, including survival, medical expenses, and individual economic impact.
Who can participate:
Patients aged 18 to 70 years sustaining major trauma in the period of January 2003 to December 2007 from the National Health Insurance Research Database (NHIRD)
What does the study involve?
This study involves a 10-year long-term follow-up from the NHIRD data. Information including the patient’s age, injury types, admission length, insurance amount, medical expense, and survival will be analyzed.
What are the possible benefits and risks of participating?
This is a retrospective observational database study. There are no potential benefits and risks for the participants.
Where is the study run from:
The Health and Welfare Data Science Center (Taiwan)
When is the study starting and how long is it expected to run for?
May 2020 to April 2021
Who is funding the study?
1. Chang Gung Memorial Hospital, Linkou (Taiwan)
2. Ministry of Science and Technology (Taiwan)
Who is the main contact?
Dr Ling-Wei Kuo, m0102@cgmh.org.tw
Contact information
Public, Scientific, Principal Investigator
No.5, Fuxing St., Guishan Dist.
Taoyuan City
333
Taiwan
 ORCID ID |
0000-0001-6489-3723 |
|---|---|
| Phone | +886 (0)975361358 |
| m0102@cgmh.org.tw |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital, Internet/virtual |
| Study type | Other, Quality of life |
| Scientific title | The long-term results of major trauma patients: a nationwide cohort study from Taiwan's national health insurance database |
| Study objectives | The long-term result of major trauma is mostly unknown until the present day. The traditional trimodal distribution of deaths was first described in 1982, implying that death due to injury occurs at three peaks. The first peak occurs within seconds to minutes of injury, the second peak occurs within minutes to several hours following injury, and the third peak occurs several days to weeks after the initial injury. However, research regarding the long-term results is scarce. The purpose of this study is to better define the long-term outcome of major trauma patients, including aspects of survival, medical expense, and individual economic impact. |
| Ethics approval(s) |
Approved 30/04/2020, Chang Gung Medical Foundation IRB (Tung Hwa North Road, Taipei, 199, Taiwan; +886 (0)3 3196200 ext #3705~3708; irb1@cgmh.org.tw), ref: Reference number not provided |
| Health condition(s) or problem(s) studied | Major trauma |
| Intervention | The researchers will retrospectively collect data of adult patients aged 18 to 70 years sustaining major trauma (injury severity score, Injury Severity Score [ISS] ≥16) in Taiwan in the period of January 2003 to December 2007 from the National Health Insurance Research Database (NHIRD) under the NHIRD regulation, and perform a 10-year long-term follow from the NHIRD data. The NHIRD is a de-identified database that contain all the procedure and expense in the National Health Insurance system. The researchers expect to enrol 25000 patients treated with major trauma as the experimental group and 50000 patients from the general population as the control group. Information including the patient’s age, injury types, admission length, insurance amount, medical expense, and survival will be analyzed. Basic demographics and short-term outcomes were analyzed, and the 10-year long-term outcome was calculated. After the analysis, the researchers will establish long-term results for major trauma patients, thus understanding the impact of major trauma in Taiwan from medical, social, and economic aspects. |
| Intervention type | Other |
| Primary outcome measure | 10-year cumulative survival rate. Survival is defined as the death date recorded in the NHIRD. Patients were further stratified into two groups: short survival (SS) and long survival (LS). SS was defined as survival <1 year after being discharged from the index admission, whereas LS was defined as survival ≥1 year after being discharged from the index admission. |
| Secondary outcome measures | 1. Long-term nursing care (LTC). LTC was defined as being admitted to a chronic ward or having skilled nursing care in the outpatient fashion 1 year after the discharge from the index admission. The record of chronic ward admission could be found in the Inpatient Expenditures by Admissions file in the NHIRD, and the record of skilled nursing care could be found in the Ambulatory Care Expenditures by Visits file in the NHIRD. 2. Post-injury income. To define the income level of the target population, the researchers first examined the NHI payroll bracket. The payroll bracket can be divided into six categories. Categories 1, 2, and 3 consist of the people who have registered sources of income, including all the employees, employers, self-employed workers who belong to occupational unions. Category 4 belongs to military servicemen/women and those who are serving sentences in a penitentiary. Categories 5 and 6 are welfare-associated, mainly comprising members of low household income and veterans. For categories 1 to 3, the monthly income is equivalent to the insurance amount, but the premiums of the beneficiaries in categories 4 to 6 were calculated differently and did not reflect the actual income. Therefore, categories 4 to 6 were ruled out from the analysis. The researchers then considered the ID number of the insured. If the personal ID number matched the insured ID number, it indicated that this person was an actual working person with registered income. If the ID numbers did not match, it implied that this person was fostered by another actual working person, and he or she had no registered income. In conclusion, the researchers identified their target population by locating the actual working people in categories 1 to 3 from the payroll bracket; thus, their insurance amount reflected their income level. The median preinjury monthly income of the enrolled patients was 640 US dollars (USD), hence preinjury monthly income ≤640 USD was classified as low income, whereas >640 USD was considered high income. 3. Return to work (RTW). The researchers recorded the preinjury insurance amount of actual working people identified from categories 1-3. One month after discharge, patients were examined again. Those who moved to categories 4-6 were placed in the non-RTW group, indicating loss of work ability due to reliance on welfare or imprisonment. If their category remained in 1-3, but the insurance amount dropped to zero, it suggested that they no longer had registered income but were insured under another actual working person. These patients were also placed in the non-RTW group. Patients were placed in the RTW group only if they remained in categories 1 to 3 and continued to have registered income. |
| Overall study start date | 01/05/2020 |
| Completion date | 30/04/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 25000 |
| Total final enrolment | 23442 |
| Key inclusion criteria | This retrospective observational study included all patients aged 18 to 70 years with major trauma in Taiwan from January 2003 to December 2007 |
| Key exclusion criteria | 1. <18 years old or >70 years old 2. ISS <16 3. Patients who had previously received a catastrophic illness certificate (CIC) for other serious conditions |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Taoyuan City
333
Taiwan
Sponsor information
Hospital/treatment centre
No.5, Fuxing St., Guishan Dist.
Taoyuan City
333
Taiwan
| Phone | +886 (0)3 3281200 |
|---|---|
| m0102@cgmh.org.tw | |
| Website | http://www1.cgmh.org.tw/branch/lnk/e/index.aspx |
"ROR" |
https://ror.org/02dnn6q67 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Ministry of Science and Technology, R.O.C. (Taiwan), Ministry of Science and Technology of Taiwan, MOST
- Location
- Taiwan
No information available
Results and Publications
| Intention to publish date | 01/05/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analyzed during the current study are not publicly available due to the patient confidentiality restrictions of the NHIRD but are available from the NHIRD on reasonable request. |
Editorial Notes
07/12/2023: Study's existence confirmed by the Chang Gung Medical Foundation IRB.
