Exploring the Long-Term Disability Outcomes in Trauma Patients: Study Protocol

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However, studies reflecting the Asian experience are limited. Therefore, we aim to develop a digital trauma registry to prospectively capture patient-reported outcomes (PROs) at one-, three-, six-, and twelve-months post-injury in Pakistan. Methods We will use a cohort study design to develop a digital trauma registry at two tertiary care facilities (Aga Khan University Hospital & Jinnah Postgraduate Medical Center) in Karachi, Pakistan. The registry will include all admitted adult trauma patients (≥18 years). Data collection will be digital using tablets, with mortality, level of disability, and functional status, quality of life being the outcomes. Telephonic interviews will be conducted with the patients and caregivers for follow-up data collection. Discussion The high disability burden following accidental trauma imposes a significant burden and cost on individuals and society. Therefore, the trauma registry would fill this gap by capturing post-discharge long-term PROs. It will provide the injured patient's post-discharge situation, challenges, and future directions for incorporating long-term PROs in low-resource settings. Including long-term measures in routine follow-ups will provide insights into physical, social, and policy barriers and help advance injury care research. Patient Reported Outcomes Digital Trauma Registries Disabilities low- and middle- income countries Contribution to literature The majority of injuries occur in LMICS, and little is known about the injured patient's post-hospital outcomes. Assessing the level of disability our patients are suffering and how these outcomes may be addressed after discharge to optimize rehabilitation requires a focus on long-term outcomes. This study is among the few studies that address this knowledge gap and determine the patient-reported long-term outcomes. Introduction Trauma is a global public health concern. With almost 1 in 10 fatalities, injuries rank among the leading causes of morbidity and mortality worldwide. According to the Global Burden of Disease report from 2019, injuries accounted for 7.6% of global mortality, with traffic fatalities being the leading cause and accounting for 2.9% of disability life-adjusted years (DALYs). 1 , 2 In low- and middle-income countries (LMICs), where DALYs are on the rise annually, this injury burden is significantly higher. 2 There are an estimated 14.3 deaths per 100,000 people in Pakistan from road traffic crashes, with a total of 27,582 (95% CI: 23,343 − 31,920) fatalities. 3 , 4 However, the estimate of injury burden is constrained because there isn't a comprehensive trauma database. 5 , 6 One approach for collecting information about injuries is the usage of trauma registries. They are an integral part of advanced trauma systems to promote injury prevention and improve patient outcomes. 7 – 9 Evidence supports improved trauma care with well-established registries. 10 However, most registries are limited by a lack of post-discharge data (survival, functional status, disability), which is essential in understanding the long-term impact of trauma care. 11 , 12 Furthermore, most registries focus on mortality as an outcome and few on functional status at discharge. 10 , 11 Increased costs associated with setting up a trauma registry and the continuous expenditure of human resources to collect and analyze data have limited LMICs from building their data systems. 11 Cost-effective measures have been identified, which has led to an increase in the establishment of trauma registries in resource-constrained regions of South Asia, East, and South Africa. However, these systems still lack measures of sustainability and long-term operation. 13 A scoping review estimates 43 functional registries in LMICs, with only 10 using their data productively. 13 This depicts a need to focus on assessing long-term disability outcomes in trauma patients to understand its burden and identify solutions required to cater to it. In Pakistan, a developing country in South Asia, 6% of mortality is caused due to injuries alone, with youth and middle-aged people most susceptible to it. 14 Trauma registries have been piloted and implemented at various levels in Pakistan, but barriers such as extensive cost and missing data have limited its successful application. Several cross-sectional studies highlight the demographics, causes, and interventions taken for trauma patients in Pakistan, 15 , 16 but few efforts have been made to collect long-term outcomes following trauma. 17 Patient-reported outcomes can bridge this knowledge gap and better inform clinical decision-making and quality improvement efforts. 12 However, this information is not available in Pakistan. This study aims to develop a digital trauma registry to prospectively capture patient-reported disability outcomes (PROs) at one-, three-, six- and twelve months post-injury in Pakistan. Methods Study Design and Setting We will use a prospective cohort study design. With nearly 212 million residents, Pakistan has the sixth-highest population in the world. Karachi has the eleventh-highest population worldwide. The registry will be established in two major tertiary care hospitals in Karachi, Pakistan. The Aga Khan University Hospital (AKUH) is a private sector hospital, while Jinnah Postgraduate Medical Centre (JPMC) is a public sector hospital. With an average bed capacity of (AKUH = 760 beds and JPMC = 2000 beds), these teaching hospitals offer tertiary care. Each facility has its own emergency room. Compared to JPMC's emergency room, which saw over one million patients a year, AKUH saw over 55,000 patients annually. General surgeons, anaesthesiologists, orthopaedic, and neurosurgery surgeons were present in both institutions. Both institutes have developed treatment protocols to address acute emergencies. Over 80% of the necessary supplies and equipment are available in both institutions. Eligibility Criteria All admitted adult trauma patients (≥ 18 years) with one or more traumatic injuries, which is defined as the injury being severe enough to need hospitalization for at least 24 hours will be included. The patients will be included from the wards (orthopaedics/general surgery/thoracic) ICU/HDU. Patients under 18, those unable to communicate verbally without a proxy, and those released from hospital within 24 hours will not be included. Sample Size For the follow-ups we estimated a sample of 1365 individuals, 80% power with an r-square ranging between 0.1 to 0.6, the anticipated odds ratio of 1.75 or more, anticipated probability of having an outcome (functional limitation) of 30% or more at a 0.05 level of significance. 18 Planning, needs assessment and stakeholder engagement We conducted an initial needs assessment to determine the current situation of injury data collection, defined specific data points to be collected, identified challenges/barriers in setting up a trauma registry, and identified solutions to overcome these challenges. Next, we will identify and engage key stakeholders, including hospital leadership, administrators, departments, and clinicians, to get their buy-in on the project. The Registry We will develop a digital trauma registry to assess short, medium, and long-term disability outcomes. We will recruit admitted patients in the hospital using the trauma registry questionnaire. The data will be collected 8–10 hours per day, six days a week, during the morning shift (9 a.m.-5:30 p.m.). In addition, we will follow up with patients telephonically at one, three, six- and twelve months post-discharge. The development of trauma registry questionnaire The study team developed, refined, and finalized the trauma registry questionnaire. We primarily used the Collector Trauma Registry as a guideline to develop the in-hospital registry questionnaire.19 We added a few context-specific variables (e.g., ethnicity, occupational classification) related to trauma systems in LMICs. We refined the questionnaire using multiple rounds of discussions with national and international experts (Emergency Medicine physicians, trauma surgeons, and public health experts). The experts gave input on selecting variables, sequencing, language, and outcome measures. Based on the expert's feedback, outcomes, such as septic complications and duration of stay, were added. We pretested the questionnaire on twenty eligible trauma patients in AKUH. We assessed the individual questions and the overall design of the questionnaire. We identified the necessary changes in sequencing and language and updated the questionnaire. Finally, the modified questionnaire was again administered to a few more patients. The registry is simple, with clear and standardized fields, and uses drop-down menus to minimize errors. The complete set of variables is shown in Table 1 . Table 1 Variables included in the in-hospital trauma registry questionnaire Categories Variable Demographic Information Name, age, medical registration number, gender, ethnicity, contact details, address, education status, occupation, the status of employment prior to the injury, comorbidities, disability status prior to the injury, functional health status prior to the injury Injury Details Cause of injury, injury data and time, geographic location of the injury, type of trauma, nature of the injury, International Classification of Diseases (ICD-10) location code (provisional), diagnosis, protective devices, Abbreviated Injury Scale (AIS), Injury Severity Score (ISS), and Trauma Score and Injury Severity Score ( TRISS) score Inter-hospital case management data Name of prior facility, arrival by, name of ambulance service, treatment if given in ambulance, referral, arrival date at facility, workup done at referring facility, treatment list/medication given in prior facility, procedures done in the prior facility, departure date. Tracking of patients as he/she moves from ED to OT/HDU/ICU/wards Location tracking, service tracking, blood transfusions, radiological procedure, surgical procedures, other procedures, and medications. Outcomes Discharge outcome, discharge/death date and time, duration of stay, septic complications, disability status at discharge, functional health status at discharge Outcome Measures The outcome measures are discharge outcomes, in-hospital and post-discharge mortality, duration of stay, septic complications, functional status, quality of life (QoL), and psychosocial outcomes (PTSD) (Table 2 ). Table 2 In-hospital and Follow-up questionnaires data collection methods and time points (Patient-reported outcomes) Questionnaire Content Data Collection Method Data Collection Time point In-hospital Trauma Registry Questionnaire Demographics, injury details, inter-hospital case management, tracking of patients as he/she moves from emergency (ED) to operation theatre (OT)/High dependency unit (HDU)/ Intensive Care Units (ICU)/wards, Outcomes Medical Records, In-person interviews In-hospital and within one week of discharge Follow-up questionnaires at one, three, six-, and twelve-months post discharge Functional Independence Measure (FIM) Self-care, sphincter control, transfer, locomotion, communication, and social cognition Telephonic Interview with patient/proxy Within one week of discharge, one, three, six-, and twelve-months post discharge Trauma Quality of Life (TQoL) Emotional well-being, recovery and resilience, physical well-being, functional engagement, and peri-traumatic experience Telephonic Interview with patient/proxy One, three, six-, and twelve-months post discharge Primary Care PTSD Screen for DSM PTSD Telephonic Interview with patient/proxy One, three, six-, and twelve-months post discharge We used the following questionnaires to record patient's reported outcomes for functional limitations, quality of life, and PTSD at one, three, six-, and twelve-months post discharge follow-ups. The questionnaires were translated into Urdu and later back-translated into English by native Urdu speakers fluent in English and Urdu. We pretested the questionnaire to assess whether the words and terms used in the Urdu version were clear, relevant, and comprehensible. Functional Independence Measure (FIM): The Functional Independence Measure (FIM) tool is a fundamental measure of patient disability . The 18 items in the FIM instrument comprise six domains, as mentioned in Table 2 . A scale of 1 (complete dependence) to 7 (complete independence) is used to rate each item; higher scores signify a higher level of functional independence (summed scores range from 18 to 126). Independent studies have provided evidence of the FIM instrument's validity and reliability, including self-report through phone interview. 20 , 21 An intra-class correlation coefficient of 0.97 indicates good agreement between FIM overall score obtained over the phone and in-person. 21 Trauma Quality of Life (TQoL): The revised trauma quality of life (RT-QoL) instrument measures trauma specific long-term quality of life outcomes. This is a five-component, 43-item questionnaire, with the five domains specified in Table 2 . 22 Primary Care PTSD Screen for DSM: This questionnaire is used to assess post traumatic stress disorder (PTSD). The questionnaire screens with an item which assesses lifetime exposure to traumatic events. If a respondent denies exposure, the PC-PTSD-5 is complete with a score of 0. However, if a respondent indicates that they have had any lifetime exposure to trauma, the respondent is instructed to respond to 5 additional yes/no questions about how that trauma exposure has affected them over the past month. 23 Personnel and training The research team comprises a team lead, a research specialist who coordinates the day-to-day activities, and three medical officers who will collect data. They attended two days of training: one day in class and one-day on-site training. They received training on software use, ICD-10 coding, Abbreviated Injury Scale (AIS), Injury Severity Score (ISS), and Revised Trauma Score (RTS) training. We will also provide frequent refresher training (every 2–3 months) to address data collection challenges and train new data collectors. Recruitment The data collector will be placed in the wards (orthopedics, general surgery, and thoracic) and surgical Intensive Care Unit (ICU)/ High dependency Unit (HDU). With the assistance of nurses, doctors, admission registers, they will identify new admissions and, after obtaining informed consent, and patients meeting the eligibility criteria the subjects will be enrolled in the study. Then, they will interview the patient at the bedside to collect the required basic information. If the patient cannot answer, the caregivers will be interviewed. Next, the data collector will extract detailed information from the medical records (labs, radiology reports, and discharge summary). Finally, at the time of discharge, the patient/caregiver will be re-interviewed. If the patient leaves the hospital before being interviewed, they will be telephonically followed up within a week of discharge to document discharge outcomes. Follow-ups Patients enrolled in the study will be followed across the continuum of recovery. These will comprise twenty to twenty-five-minute telephonic interviews. The interview will have an initial screening, verbal consent, and questions about his/her recovery. The patients will be approached up to ten times, after which he/she will be considered a loss for follow-up. Data Entry We will enter data through digital software (RedCap). 24 RedCap is a free-of-cost, secure web application for surveys and databases. Online data entry at RedCap is fast, flexible, and easy to use. We will build the project database on RedCap by uploading the data collection tools (trauma registry and follow-up questionnaires). To ensure that data collection tools look and work as we intend, we will create a few test records and enter some data for each tool. Quality assurance The data collectors will use an excel sheet to send daily updates of newly enrolled patients and the number of follow-ups calls through google docs. Additionally, only team members will have access to Google Docs. These forms, however, will report the ID numbers and do not contain any patient identifiers. This information will be stored on a password-protected computer. The research specialist (RS) will close out the cases on Google Documents after verifying them on Redcap. The PI will receive weekly updates and cross check the enrollments on a regular basis. The research specialist will make random visits weekly to oversee data collection, spot and address field problems, and ensure all eligible patients are enrolled in the study by comparing enrolled participants with admission lists and ensure quality checks at field site. The PI will monitor all entered data and check the data for data completeness and accuracy. We will compare the entered data elements with the patient's medical records for data accuracy. We will calculate the error rate for a subset of records to ensure data quality Data analysis We will conduct a descriptive analysis to summarize the participant profile, clinical characteristics, and outcomes, including the median and interquartile range (IQR), mean and standard deviation, and proportions (95% confidence intervals). Kaplan Meir survival curves and means will be obtained, and the log-rank test will be used to test the hypothesis that survival curves are similar. The coax proportional hazard model (Parametric model) will be used to perform survival analysis. Assumptions of proportionality of hazards will be assessed. We will use univariate logistic regression to assess the association between potential predictor variables and each outcome. Variables with an overall model p-value of < 0.25 will be considered eligible for entering the model-building stage, and a likelihood ratio test will be performed at each step. Multicollinearity among the qualifying variables will be checked using correlation coefficients for quantitative variables and Kramer's V for categorical variables. Adjusted odds ratios (AOR) and 95% CI will be calculated. The significance level of all statistical tests will be considered at 0.05. Stata for windows version 14 will be used for analysis. For FIM, mean and standard deviation will be reported for one, three, and six months. For TQoL, the mean and standard deviation will be reported for all three sub-components, along with the mean and standard deviation for the overall score. Discussion The study aims to describe the design and methodology of setting up a digital trauma registry to capture long-term disability-related outcomes in Pakistan. It will also provide a comprehensive insight into trauma-related disabilities and how they affect injured patients by looking at their current level of disability and return to work. This will provide an opportunity for recommendations for incorporating PROMs into trauma registries in LMICs to maximize the rehabilitation and reintegration of the injured into society. Strengths This will be among the first studies in Pakistan to collect PROs over a long-time frame following a traumatic injury. This study employs a prospective cohort study design to capture estimates of disability among injured patients using validated instruments at one month, three months, six months, and twelve months following the injury in Pakistan. This study's large sample size increases the accuracy and generalizability of the findings. In this study, we will calculate the injury severity score and revised trauma score, which are important measures of severe injury. Also, we will assess elements like PTSD that could directly impact outcomes related to disabilities. Limitations The study has some limitations. The study will be carried out in two trauma centres with different volumes, patient flow systems, and resource availability. This might not accurately represent the situation in other local trauma centres in the country. Due to practical reasons, we will not include paediatric trauma patients, missing a substantial proportion of the population contributing to the trauma burden. In addition, we will not fully account for the trauma burden (minor injuries, brought dead, and mortalities in the ED) because we will only include admitted patients. However, since we intend to recruit participants with whom we can follow up to learn more about long-term consequences, collecting the whole trauma burden is not the study's objective. Some patients will be missed since there will be only eight to ten hours of data collection per day, six days per week. Patients admitted on Sundays or holidays and those who pass away or leave against medical advice at night are only a few examples. There may be differences between missed and admitted patients, and the generalizability may be limited. The extraction of data from medical records may pose certain challenges. Some of the variables in the medical records might be missing or have inconsistent data. Data entry is dependent on the availability of electricity and high-quality internet. There may be challenges related to telephonic follow-ups. Inaccurate phone numbers, inactive phone numbers, female patients' reluctance to participate, and non-response may pose follow-up barriers. Conclusion The high disability burden following accidental trauma imposes a significant burden and cost on individuals and society. Therefore, the trauma registry would fill this gap by capturing post-discharge long-term PROs. It will provide the injured patient's post-discharge situation, challenges, and future directions for incorporating long-term PROs in low-resource settings. Including long-term measures in routine follow-ups will provide insights into physical, social, and policy barriers and help advance injury care research. Abbreviations PROs: Patient-Reported Outcomes ED: Emergency Department AIS: Abbreviated Injury Scale ISS: Injury Severity Score TRISS: Trauma Score and Injury Severity Score QoL: Quality of Life PTSD: Post-Traumatic Stress Disorder Declarations Ethics approval and consent to participate This study was approved by both The AKUH Ethics Review Committee (ERC Reference No. 2021-6251-18973) and the JPMC Institutional Review Board Committee (Reference No. F.2-81/2021-GENL/70586/JPMC). The study complies with the Declaration of Helsinki. Informed verbal consent was obtained from all the participants before starting data collection. Participation was voluntary, and the right to ask any questions and to decline participation/leave the study at any time was emphasized during the data collection. Data was anonymized during data management, analysis, and reporting. Consent for publication Not applicable Availability of data and materials Not applicable Acknowledgement: We are thankful to Seemi Jamali for helping us carry out the study at Jinnah Postgraduate Medical Centre. We also acknowledge Dr Hasnain Zafar for his insightful comments that helped us to finalise the registry variables. We would also like to thank Dr Fatima Bano for helping us develop the registry questionnaires on RedCap. Disclaimer: None Conflict of interest: The authors have no conflicts of interest to disclose. Funding disclosure: Research reported in this publication was supported by the Fogarty International Center of the National Institutes of Health under Award Number D43TW007292 - the Aga Khan University Trauma and injury research training program. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Authors' contributions: NS, AAHM, and JR conceived the idea of this manuscript; NS, AAHM wrote the manuscript; NS, JR, AAH, and AH critically revised the paper and provided valuable feedback. All authors read and approved the final manuscript. Authors Affiliations 1 Centre of Excellence for Trauma and Emergencies, Aga Khan University, Karachi, Pakistan. 2 Department of Epidemiology, Robert Stempel College of Public Health & Social Work, Florida International University, USA. 2 Medical College, Aga Khan University, Karachi, Pakistan. 3 Department of Emergency Medicine, Aga Khan University Hospital, Karachi, Pakistan. 4 Department of Neurosurgery, Jinnah Postgraduate Medical Centre, Karachi, Sindh, Pakistan 5 Department of Emergency Medicine, Jinnah Postgraduate Medical Centre, Karachi, Sindh, Pakistan. 6 Department of Surgery, Jinnah Postgraduate Medical Centre, Karachi, Sindh, Pakistan. 7 Milken Institute School of Public Health, George Washington University, Washington, DC, USA. 8 Department of Emergency Medicine, Weill Cornell Medicine, New York, USA. 9 Department of Surgery and Community Health Sciences, Aga Khan University, Karachi, Pakistan . References VizHub - GBD Compare [Internet]. [cited 2022 Oct 1]. Available from: https://vizhub.healthdata.org/gbd-compare/ Abbafati C, Abbas KM, Abbasi-Kangevari M, Abd-Allah F, Abdelalim A, Abdollahi M, et al. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet (London, England) [Internet]. 2020 Oct 17 [cited 2022 Oct 1];396(10258):1204–22. Available from: https://pubmed.ncbi.nlm.nih.gov/33069326/ WHO | Death on the roads [Internet]. [cited 2022 Oct 2]. Available from: https://extranet.who.int/roadsafety/death-on-the-roads/#country_or_area/PAK WHO. World health statistics 2018: monitoring health for the SDGs [Internet]. Vol. 7, Pakistan Research Journal of Management Sciences. 2018. Available from: http://content.ebscohost.com/ContentServer.asp?EbscoContent=dGJyMNLe80Sep7Q4y9f3OLCmr1Gep7JSsKy4Sa6WxWXS&ContentCustomer= dGJyMPGptk%2B3rLJNuePfgeyx43zx1%2B6B&T=P&P=AN&S=R&D=buh&K=134748798%0Ahttp://amg.um.dk/~/media/amg/Documents/Policies and Strategies/S Shanthakumar D, Payne A, Leitch T, Alfa-Wali M. Trauma Care in Low- and Middle-Income Countries. The Surgery Journal [Internet]. 2021 Oct [cited 2022 Oct 1];7(4):e281. Available from: /pmc/articles/PMC8536645/ Pop B, Fetica B, Blaga ML, Trifa AP, Achimas-Cadariu P, Vlad CI, et al. The role of medical registries, potential applications and limitations. Medicine and Pharmacy Reports [Internet]. 2019 [cited 2022 Oct 1];92(1):7. Available from: /pmc/articles/PMC6448488/ Kamp O, Pfeifer R, Ritschel M, Flohe S, Bieler D. Polytrauma outcome: implementation of health-related quality of life assessment into the German Trauma Registry. European Journal of Trauma and Emergency Surgery [Internet]. 2021 Jun 1 [cited 2022 Oct 1];47(3):869–74. Available from: https://link.springer.com/article/10.1007/s00068-019-01270-7 Ford JE, Alqahtani AS, Abuzinada SAA, Cameron PA, Fitzgerald MC, Alenizi AS, et al. Experience gained from the implementation of the Saudi TraumA Registry (STAR). BMC Health Services Research. 2020;20(1). Tyson AF, Varela C, Cairns BA, Charles AG. Hospital Mortality Following Trauma: An Analysis of a Hospital-Based Injury Surveillance Registry in sub-Saharan Africa. Journal of Surgical Education. 2015 Jul 1;72(4):e66–72. Williamson OD, Gabbe BJ, Sutherland AM, Wolfe R, Forbes AB, Cameron PA. Comparing the responsiveness of functional outcome assessment measures for trauma registries. Journal of Trauma - Injury, Infection and Critical Care [Internet]. 2011 Jul [cited 2022 Oct 2];71(1):63–8. Available from: https://journals.lww.com/jtrauma/Fulltext/2011/07000/Comparing_the_Responsiveness_of_Functional_Outcome.11.aspx Rosenkrantz L, Schuurman N, Arenas C, Nicol A, Hameed MS. Maximizing the potential of trauma registries in low-income and middle-income countries. Trauma Surgery & Acute Care Open [Internet]. 2020 May 1 [cited 2022 Oct 1];5(1):e000469. Available from: https://tsaco.bmj.com/content/5/1/e000469 Rios-Diaz AJ, Herrera-Escobar JP, Lilley EJ, Appelson JR, Gabbe B, Brasel K, et al. Routine inclusion of long-term functional and patient-reported outcomes into trauma registries: The FORTE project. Journal of Trauma and Acute Care Surgery. 2017 Jul 1;83(1):97–104. Rosenkrantz L, Schuurman N, Hameed M. Trauma registry implementation and operation in low and middle income countries: A scoping review. https://doi.org/101080/1744169220191622761 [Internet]. 2019 Dec 2 [cited 2022 Oct 1];14(12):1884–97. Available from: https://www.tandfonline.com/doi/abs/10.1080/17441692.2019.1622761 Hyder AA, Razzak JA. The challenges of injuries and trauma in Pakistan: An opportunity for concerted action. Public health [Internet]. 2013 Aug [cited 2022 Sep 23];127(8):699. Available from: /pmc/articles/PMC4313547/ Tanoli O, Ahmad H, Khan H, Khattak FA, Khan A, Mikhail A, et al. A pilot trauma registry in Peshawar, Pakistan - A roadmap to decreasing the burden of injury - Quality improvement study. Annals of medicine and surgery (2012) [Internet]. 2021 Dec 1 [cited 2022 Oct 1];72. Available from: https://pubmed.ncbi.nlm.nih.gov/34934485/ Mehmood A, Razzak JA, Kabir S, Mackenzie EJ, Hyder AA. Development and pilot implementation of a locally developed Trauma Registry: lessons learnt in a low-income country [Internet]. 2013. Available from: http://www.biomedcentral.com/1471-227X/13/4 Ahmad T, Muhammad ZA. Patient outcomes association with patient factors and care provided: trauma registry derived cohort study. Journal of the Pakistan Medical Association. 2020;70(2):S10–4. Haider AH, Herrera-Escobar JP, Al Rafai SS, Harlow AF, Apoj M, Nehra D, et al. Factors associated with long-term outcomes after injury: Results of the functional outcomes and recovery after trauma emergencies (FORTE) multicenter cohort study. Annals of Surgery. 2020;271(6):1165–73. NSW Trauma Registry System | Institute of Trauma and Injury Management | ACI [Internet]. [cited 2022 Oct 2]. Available from: https://aci.health.nsw.gov.au/networks/itim/data/nsw_trauma_registry_system Ottenbacher KJ, Hsu Y, Granger C V., Fiedler RC. The reliability of the functional independence measure: A quantitative review. Archives of Physical Medicine and Rehabilitation [Internet]. 1996 Dec 1 [cited 2022 Oct 1];77(12):1226–32. Available from: http://www.archives-pmr.org/article/S0003999396901847/fulltext Smith PM, Illig SB, Fielder RC, Hamilton BB, Ottenbacher KJ. Intermodal agreement of follow-up telephone functional assessment using the functional independence measure in patients with stroke. Archives of Physical Medicine and Rehabilitation [Internet]. 1996 May 1 [cited 2022 Oct 1];77(5):431–5. Available from: http://www.archives-pmr.org/article/S0003999396900295/fulltext Herrera-Escobar JP, Deroon-Cassini T, Brasel K, Nehra D, Al Rafai SS, Toppo A, et al. Development and validation of a revised trauma-specific quality of life instrument. Journal of Trauma and Acute Care Surgery [Internet]. 2020 Apr 1 [cited 2022 Oct 1];88(4):501–7. Available from: https://journals.lww.com/jtrauma/Fulltext/2020/04000/Development_and_validation_of_a_revised.5.aspx Prins A, Bovin MJ, Smolenski DJ, Marx BP, Kimerling R, Jenkins-Guarnieri MA, et al. The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5): Development and Evaluation Within a Veteran Primary Care Sample. Journal of general internal medicine [Internet]. 2016 Oct 1 [cited 2022 Oct 1];31(10):1206–11. Available from: https://pubmed.ncbi.nlm.nih.gov/27170304/ Crane S, Comer RS, Arenson AD, Draucker C. Using REDCap to Facilitate Web-Based Therapeutic Intervention Research. Nursing research [Internet]. 2019 Nov 1 [cited 2022 Oct 1];68(6):483–7. Available from: https://pubmed.ncbi.nlm.nih.gov/31693554/ Additional Declarations No competing interests reported. Cite Share Download PDF Status: Published Journal Publication published 23 Oct, 2024 Read the published version in Archives of Public Health → Version 1 posted Editorial decision: Revision requested 19 Jun, 2024 Reviews received at journal 18 Jun, 2024 Reviewers agreed at journal 11 Jun, 2024 Reviews received at journal 13 May, 2024 Reviewers agreed at journal 02 May, 2024 Reviewers invited by journal 29 Apr, 2024 Submission checks completed at journal 11 Apr, 2024 Editor assigned by journal 11 Apr, 2024 First submitted to journal 08 Apr, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4238506","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Study protocol","associatedPublications":[],"authors":[{"id":289004774,"identity":"f8ecea67-026c-4649-adb9-a50e5b06890d","order_by":0,"name":"Natasha Shaukat","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAuElEQVRIiWNgGAWjYFACHiA2kODhZz7YAGQxE6ulwkZGsi2RJC1n0mwMjiUwEKfFnP/swc+8bYd5jI8xt0kwVFiD7cILLGfkJUuDtJgdYwRqOZNOWIvBDR4DiJb7jW0SjG2HidBy/ozxb7DD2oC2MP4jRsuBHDNpnjNpPAZsIC0NxGi5kWNmOafChkfiGGOzRcKxdGOiHHbjjYGEPX8b+8MbH2qsZQlqQQUJpCkfBaNgFIyCUYALAABUzDrQy0OqAwAAAABJRU5ErkJggg==","orcid":"","institution":"Aga Khan University","correspondingAuthor":true,"prefix":"","firstName":"Natasha","middleName":"","lastName":"Shaukat","suffix":""},{"id":289004775,"identity":"f5032838-e0cc-46ee-bd22-2a82be5f2b3f","order_by":1,"name":"Asma Altaf Hussain Merchant","email":"","orcid":"","institution":"Aga Khan University","correspondingAuthor":false,"prefix":"","firstName":"Asma","middleName":"Altaf Hussain","lastName":"Merchant","suffix":""},{"id":289004776,"identity":"2ed08658-e736-4a6d-9284-e375cc5c85df","order_by":2,"name":"Fazila Sahibjan","email":"","orcid":"","institution":"Aga Khan University","correspondingAuthor":false,"prefix":"","firstName":"Fazila","middleName":"","lastName":"Sahibjan","suffix":""},{"id":289004777,"identity":"dc16fcf1-8b87-47a1-aec2-00496973b4f1","order_by":3,"name":"Ayesha Abbasi","email":"","orcid":"","institution":"Aga Khan University","correspondingAuthor":false,"prefix":"","firstName":"Ayesha","middleName":"","lastName":"Abbasi","suffix":""},{"id":289004778,"identity":"ccbcd297-c824-4a73-a126-4905d6734ea2","order_by":4,"name":"Zeerak Jarrar","email":"","orcid":"","institution":"Aga Khan University","correspondingAuthor":false,"prefix":"","firstName":"Zeerak","middleName":"","lastName":"Jarrar","suffix":""},{"id":289004779,"identity":"8e91fc0c-d14b-49b1-a8aa-87fd54e38c91","order_by":5,"name":"Tanweer Ahmed","email":"","orcid":"","institution":"Jinnah Postgraduate Medical Center","correspondingAuthor":false,"prefix":"","firstName":"Tanweer","middleName":"","lastName":"Ahmed","suffix":""},{"id":289004780,"identity":"5eb03711-4465-4396-b005-81ef396efcfc","order_by":6,"name":"Huba Atiq","email":"","orcid":"","institution":"Aga Khan University","correspondingAuthor":false,"prefix":"","firstName":"Huba","middleName":"","lastName":"Atiq","suffix":""},{"id":289004781,"identity":"d22f1931-a294-4b4d-8873-99b641eda277","order_by":7,"name":"Uzma Rahim Khan","email":"","orcid":"","institution":"Aga Khan University","correspondingAuthor":false,"prefix":"","firstName":"Uzma","middleName":"Rahim","lastName":"Khan","suffix":""},{"id":289004782,"identity":"9363e5a8-686a-4d28-81b6-d6e7e176b2a7","order_by":8,"name":"NadeemUllah Khan","email":"","orcid":"","institution":"Aga Khan University","correspondingAuthor":false,"prefix":"","firstName":"NadeemUllah","middleName":"","lastName":"Khan","suffix":""},{"id":289004783,"identity":"07b7740e-cde6-4897-8d01-cf2371d6e48d","order_by":9,"name":"Saima Mushtaq","email":"","orcid":"","institution":"Jinnah Postgraduate Medical Center","correspondingAuthor":false,"prefix":"","firstName":"Saima","middleName":"","lastName":"Mushtaq","suffix":""},{"id":289004784,"identity":"6f0033ca-aa18-4a4e-8465-5bc83f9cb0fd","order_by":10,"name":"Shahid Rasul","email":"","orcid":"","institution":"Jinnah Postgraduate Medical Center","correspondingAuthor":false,"prefix":"","firstName":"Shahid","middleName":"","lastName":"Rasul","suffix":""},{"id":289004785,"identity":"1707e41e-d74d-41f0-ace9-3253bcde68a7","order_by":11,"name":"Adnan Hyder","email":"","orcid":"","institution":"George Washington University","correspondingAuthor":false,"prefix":"","firstName":"Adnan","middleName":"","lastName":"Hyder","suffix":""},{"id":289004786,"identity":"866f264c-09af-46ba-8f5a-5642d98dd308","order_by":12,"name":"Junaid Razzak","email":"","orcid":"","institution":"Aga Khan University","correspondingAuthor":false,"prefix":"","firstName":"Junaid","middleName":"","lastName":"Razzak","suffix":""},{"id":289004787,"identity":"400d286f-190e-481e-afac-fe5bbb58f525","order_by":13,"name":"Adil Haider","email":"","orcid":"","institution":"Aga Khan University","correspondingAuthor":false,"prefix":"","firstName":"Adil","middleName":"","lastName":"Haider","suffix":""}],"badges":[],"createdAt":"2024-04-08 20:44:14","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4238506/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4238506/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s13690-024-01385-3","type":"published","date":"2024-10-23T15:57:17+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":67681758,"identity":"259d9def-1370-4ed2-9635-46ecbd546826","added_by":"auto","created_at":"2024-10-28 16:10:02","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":486818,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4238506/v1/21caa796-4727-440c-a044-2a16bb209543.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Exploring the Long-Term Disability Outcomes in Trauma Patients: Study Protocol","fulltext":[{"header":"Contribution to literature","content":"\u003cp\u003eThe majority of injuries occur in LMICS, and little is known about the injured patient\u0026apos;s post-hospital outcomes.\u003c/p\u003e\n\u003cp\u003eAssessing the level of disability our patients are suffering and how these outcomes may be addressed after discharge to optimize rehabilitation requires a focus on long-term outcomes.\u003c/p\u003e\n\u003cp\u003eThis study is among the few studies that address this knowledge gap and determine the patient-reported long-term outcomes.\u003c/p\u003e"},{"header":"Introduction","content":"\u003cp\u003eTrauma is a global public health concern. With almost 1 in 10 fatalities, injuries rank among the leading causes of morbidity and mortality worldwide. According to the Global Burden of Disease report from 2019, injuries accounted for 7.6% of global mortality, with traffic fatalities being the leading cause and accounting for 2.9% of disability life-adjusted years (DALYs).\u003csup\u003e\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e,\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e In low- and middle-income countries (LMICs), where DALYs are on the rise annually, this injury burden is significantly higher.\u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e There are an estimated 14.3 deaths per 100,000 people in Pakistan from road traffic crashes, with a total of 27,582 (95% CI: 23,343\u0026thinsp;\u0026minus;\u0026thinsp;31,920) fatalities.\u003csup\u003e\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e,\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u003c/sup\u003e However, the estimate of injury burden is constrained because there isn't a comprehensive trauma database.\u003csup\u003e\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e,\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eOne approach for collecting information about injuries is the usage of trauma registries. They are an integral part of advanced trauma systems to promote injury prevention and improve patient outcomes.\u003csup\u003e\u003cspan additionalcitationids=\"CR8\" citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u003c/sup\u003e Evidence supports improved trauma care with well-established registries.\u003csup\u003e\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u003c/sup\u003e However, most registries are limited by a lack of post-discharge data (survival, functional status, disability), which is essential in understanding the long-term impact of trauma care.\u003csup\u003e\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e,\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e Furthermore, most registries focus on mortality as an outcome and few on functional status at discharge.\u003csup\u003e\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e,\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eIncreased costs associated with setting up a trauma registry and the continuous expenditure of human resources to collect and analyze data have limited LMICs from building their data systems.\u003csup\u003e\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e Cost-effective measures have been identified, which has led to an increase in the establishment of trauma registries in resource-constrained regions of South Asia, East, and South Africa. However, these systems still lack measures of sustainability and long-term operation.\u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e A scoping review estimates 43 functional registries in LMICs, with only 10 using their data productively.\u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e This depicts a need to focus on assessing long-term disability outcomes in trauma patients to understand its burden and identify solutions required to cater to it.\u003c/p\u003e \u003cp\u003eIn Pakistan, a developing country in South Asia, 6% of mortality is caused due to injuries alone, with youth and middle-aged people most susceptible to it.\u003csup\u003e\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u003c/sup\u003e Trauma registries have been piloted and implemented at various levels in Pakistan, but barriers such as extensive cost and missing data have limited its successful application. Several cross-sectional studies highlight the demographics, causes, and interventions taken for trauma patients in Pakistan,\u003csup\u003e\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e,\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u003c/sup\u003e but few efforts have been made to collect long-term outcomes following trauma.\u003csup\u003e\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u003c/sup\u003e Patient-reported outcomes can bridge this knowledge gap and better inform clinical decision-making and quality improvement efforts.\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e However, this information is not available in Pakistan.\u003c/p\u003e \u003cp\u003eThis study aims to develop a digital trauma registry to prospectively capture patient-reported disability outcomes (PROs) at one-, three-, six- and twelve months post-injury in Pakistan.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy Design and Setting\u003c/h2\u003e \u003cp\u003eWe will use a prospective cohort study design. With nearly 212\u0026nbsp;million residents, Pakistan has the sixth-highest population in the world. Karachi has the eleventh-highest population worldwide. The registry will be established in two major tertiary care hospitals in Karachi, Pakistan. The Aga Khan University Hospital (AKUH) is a private sector hospital, while Jinnah Postgraduate Medical Centre (JPMC) is a public sector hospital.\u003c/p\u003e \u003cp\u003eWith an average bed capacity of (AKUH\u0026thinsp;=\u0026thinsp;760 beds and JPMC\u0026thinsp;=\u0026thinsp;2000 beds), these teaching hospitals offer tertiary care. Each facility has its own emergency room. Compared to JPMC's emergency room, which saw over one million patients a year, AKUH saw over 55,000 patients annually. General surgeons, anaesthesiologists, orthopaedic, and neurosurgery surgeons were present in both institutions. Both institutes have developed treatment protocols to address acute emergencies. Over 80% of the necessary supplies and equipment are available in both institutions.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eEligibility Criteria\u003c/h2\u003e \u003cp\u003eAll admitted adult trauma patients (\u0026ge;\u0026thinsp;18 years) with one or more traumatic injuries, which is defined as the injury being severe enough to need hospitalization for at least 24 hours will be included. The patients will be included from the wards (orthopaedics/general surgery/thoracic) ICU/HDU. Patients under 18, those unable to communicate verbally without a proxy, and those released from hospital within 24 hours will not be included.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eSample Size\u003c/h2\u003e \u003cp\u003eFor the follow-ups we estimated a sample of 1365 individuals, 80% power with an r-square ranging between 0.1 to 0.6, the anticipated odds ratio of 1.75 or more, anticipated probability of having an outcome (functional limitation) of 30% or more at a 0.05 level of significance.\u003csup\u003e\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003ePlanning, needs assessment and stakeholder engagement\u003c/h2\u003e \u003cp\u003eWe conducted an initial needs assessment to determine the current situation of injury data collection, defined specific data points to be collected, identified challenges/barriers in setting up a trauma registry, and identified solutions to overcome these challenges. Next, we will identify and engage key stakeholders, including hospital leadership, administrators, departments, and clinicians, to get their buy-in on the project.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eThe Registry\u003c/h2\u003e \u003cp\u003eWe will develop a digital trauma registry to assess short, medium, and long-term disability outcomes. We will recruit admitted patients in the hospital using the trauma registry questionnaire. The data will be collected 8\u0026ndash;10 hours per day, six days a week, during the morning shift (9 a.m.-5:30 p.m.). In addition, we will follow up with patients telephonically at one, three, six- and twelve months post-discharge.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eThe development of trauma registry questionnaire\u003c/h2\u003e \u003cp\u003eThe study team developed, refined, and finalized the trauma registry questionnaire. We primarily used the Collector Trauma Registry as a guideline to develop the in-hospital registry questionnaire.19 We added a few context-specific variables (e.g., ethnicity, occupational classification) related to trauma systems in LMICs. We refined the questionnaire using multiple rounds of discussions with national and international experts (Emergency Medicine physicians, trauma surgeons, and public health experts). The experts gave input on selecting variables, sequencing, language, and outcome measures. Based on the expert's feedback, outcomes, such as septic complications and duration of stay, were added. We pretested the questionnaire on twenty eligible trauma patients in AKUH. We assessed the individual questions and the overall design of the questionnaire. We identified the necessary changes in sequencing and language and updated the questionnaire. Finally, the modified questionnaire was again administered to a few more patients. The registry is simple, with clear and standardized fields, and uses drop-down menus to minimize errors. The complete set of variables is shown in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eVariables included in the in-hospital trauma registry questionnaire\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCategories\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eVariable\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDemographic Information\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eName, age, medical registration number, gender, ethnicity, contact details, address, education status, occupation, the status of employment prior to the injury, comorbidities, disability status prior to the injury, functional health status prior to the injury\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eInjury Details\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eCause of injury, injury data and time, geographic location of the injury, type of trauma, nature of the injury, International Classification of Diseases (ICD-10) location code (provisional), diagnosis, protective devices, Abbreviated Injury Scale (AIS), Injury Severity Score (ISS), and Trauma Score and Injury Severity Score \u003cb\u003e(\u003c/b\u003eTRISS) score\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eInter-hospital case management data\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eName of prior facility, arrival by, name of ambulance service, treatment if given in ambulance, referral, arrival date at facility, workup done at referring facility, treatment list/medication given in prior facility, procedures done in the prior facility, departure date.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTracking of patients as he/she moves from ED to OT/HDU/ICU/wards\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eLocation tracking, service tracking, blood transfusions, radiological procedure, surgical procedures, other procedures, and medications.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOutcomes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDischarge outcome, discharge/death date and time, duration of stay, septic complications, disability status at discharge, functional health status at discharge\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eOutcome Measures\u003c/h2\u003e \u003cp\u003eThe outcome measures are discharge outcomes, in-hospital and post-discharge mortality, duration of stay, septic complications, functional status, quality of life (QoL), and psychosocial outcomes (PTSD) (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eIn-hospital and Follow-up questionnaires data collection methods and time points (Patient-reported outcomes)\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eQuestionnaire\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eContent\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eData Collection Method\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eData Collection\u003c/p\u003e \u003cp\u003eTime point\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIn-hospital Trauma Registry Questionnaire\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDemographics, injury details, inter-hospital case management, tracking of patients as he/she moves from emergency (ED) to operation theatre (OT)/High dependency unit (HDU)/ Intensive Care Units (ICU)/wards, Outcomes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMedical Records, In-person interviews\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eIn-hospital and within one week of discharge\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e \u003cp\u003eFollow-up questionnaires at one, three, six-, and twelve-months post discharge\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFunctional Independence Measure (FIM)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSelf-care, sphincter control, transfer, locomotion, communication, and\u0026nbsp;social cognition\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eTelephonic Interview with patient/proxy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eWithin one week of discharge, one, three, six-, and twelve-months post discharge\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTrauma Quality of Life (TQoL)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eEmotional well-being, recovery and resilience, physical well-being, functional engagement, and peri-traumatic experience\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eTelephonic Interview with patient/proxy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eOne, three, six-, and twelve-months post discharge\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePrimary Care PTSD Screen for DSM\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePTSD\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eTelephonic Interview with patient/proxy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eOne, three, six-, and twelve-months post discharge\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eWe used the following questionnaires to record patient's reported outcomes for functional limitations, quality of life, and PTSD at one, three, six-, and twelve-months post discharge follow-ups. The questionnaires were translated into Urdu and later back-translated into English by native Urdu speakers fluent in English and Urdu. We pretested the questionnaire to assess whether the words and terms used in the Urdu version were clear, relevant, and comprehensible.\u003c/p\u003e \u003cp\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eFunctional Independence Measure (FIM): The Functional Independence Measure (FIM) tool is a fundamental measure of \u003cem\u003epatient disability\u003c/em\u003e. The 18 items in the FIM instrument comprise six domains, as mentioned in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e. A scale of 1 (complete dependence) to 7 (complete independence) is used to rate each item; higher scores signify a higher level of functional independence (summed scores range from 18 to 126). Independent studies have provided evidence of the FIM instrument's validity and reliability, including self-report through phone interview.\u003csup\u003e\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e,\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e\u003c/sup\u003e An intra-class correlation coefficient of 0.97 indicates good agreement between FIM overall score obtained over the phone and in-person.\u003csup\u003e\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eTrauma Quality of Life (TQoL): The revised trauma quality of life (RT-QoL) instrument measures trauma specific long-term quality of life outcomes. This is a five-component, 43-item questionnaire, with the five domains specified in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003csup\u003e\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003ePrimary Care PTSD Screen for DSM: This questionnaire is used to assess post traumatic stress disorder (PTSD). The questionnaire screens with an item which assesses lifetime exposure to traumatic events. If a respondent denies exposure, the PC-PTSD-5 is complete with a score of 0. However, if a respondent indicates that they have had any lifetime exposure to trauma, the respondent is instructed to respond to 5 additional yes/no questions about how that trauma exposure has affected them over the past month.\u003csup\u003e\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003c/li\u003e \u003c/ul\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003ePersonnel and training\u003c/h2\u003e \u003cp\u003eThe research team comprises a team lead, a research specialist who coordinates the day-to-day activities, and three medical officers who will collect data. They attended two days of training: one day in class and one-day on-site training. They received training on software use, ICD-10 coding, Abbreviated Injury Scale (AIS), Injury Severity Score (ISS), and Revised Trauma Score (RTS) training. We will also provide frequent refresher training (every 2\u0026ndash;3 months) to address data collection challenges and train new data collectors.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eRecruitment\u003c/h2\u003e \u003cp\u003eThe data collector will be placed in the wards (orthopedics, general surgery, and thoracic) and surgical Intensive Care Unit (ICU)/ High dependency Unit (HDU). With the assistance of nurses, doctors, admission registers, they will identify new admissions and, after obtaining informed consent, and patients meeting the eligibility criteria the subjects will be enrolled in the study. Then, they will interview the patient at the bedside to collect the required basic information. If the patient cannot answer, the caregivers will be interviewed. Next, the data collector will extract detailed information from the medical records (labs, radiology reports, and discharge summary). Finally, at the time of discharge, the patient/caregiver will be re-interviewed. If the patient leaves the hospital before being interviewed, they will be telephonically followed up within a week of discharge to document discharge outcomes.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eFollow-ups\u003c/h2\u003e \u003cp\u003ePatients enrolled in the study will be followed across the continuum of recovery. These will comprise twenty to twenty-five-minute telephonic interviews. The interview will have an initial screening, verbal consent, and questions about his/her recovery. The patients will be approached up to ten times, after which he/she will be considered a loss for follow-up.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eData Entry\u003c/h2\u003e \u003cp\u003eWe will enter data through digital software (RedCap).\u003csup\u003e\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e\u003c/sup\u003e RedCap is a free-of-cost, secure web application for surveys and databases. Online data entry at RedCap is fast, flexible, and easy to use. We will build the project database on RedCap by uploading the data collection tools (trauma registry and follow-up questionnaires). To ensure that data collection tools look and work as we intend, we will create a few test records and enter some data for each tool.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eQuality assurance\u003c/h2\u003e \u003cp\u003eThe data collectors will use an excel sheet to send daily updates of newly enrolled patients and the number of follow-ups calls through google docs. Additionally, only team members will have access to Google Docs. These forms, however, will report the ID numbers and do not contain any patient identifiers. This information will be stored on a password-protected computer. The research specialist (RS) will close out the cases on Google Documents after verifying them on Redcap. The PI will receive weekly updates and cross check the enrollments on a regular basis. The research specialist will make random visits weekly to oversee data collection, spot and address field problems, and ensure all eligible patients are enrolled in the study by comparing enrolled participants with admission lists and ensure quality checks at field site. The PI will monitor all entered data and check the data for data completeness and accuracy. We will compare the entered data elements with the patient's medical records for data accuracy. We will calculate the error rate for a subset of records to ensure data quality\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eData analysis\u003c/h2\u003e \u003cp\u003eWe will conduct a descriptive analysis to summarize the participant profile, clinical characteristics, and outcomes, including the median and interquartile range (IQR), mean and standard deviation, and proportions (95% confidence intervals). Kaplan Meir survival curves and means will be obtained, and the log-rank test will be used to test the hypothesis that survival curves are similar. The coax proportional hazard model (Parametric model) will be used to perform survival analysis. Assumptions of proportionality of hazards will be assessed. We will use univariate logistic regression to assess the association between potential predictor variables and each outcome. Variables with an overall model p-value of \u0026lt;\u0026thinsp;0.25 will be considered eligible for entering the model-building stage, and a likelihood ratio test will be performed at each step. Multicollinearity among the qualifying variables will be checked using correlation coefficients for quantitative variables and Kramer's V for categorical variables. Adjusted odds ratios (AOR) and 95% CI will be calculated. The significance level of all statistical tests will be considered at 0.05. Stata for windows version 14 will be used for analysis. For FIM, mean and standard deviation will be reported for one, three, and six months. For TQoL, the mean and standard deviation will be reported for all three sub-components, along with the mean and standard deviation for the overall score.\u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe study aims to describe the design and methodology of setting up a digital trauma registry to capture long-term disability-related outcomes in Pakistan. It will also provide a comprehensive insight into trauma-related disabilities and how they affect injured patients by looking at their current level of disability and return to work. This will provide an opportunity for recommendations for incorporating PROMs into trauma registries in LMICs to maximize the rehabilitation and reintegration of the injured into society.\u003c/p\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eStrengths\u003c/h2\u003e \u003cp\u003eThis will be among the first studies in Pakistan to collect PROs over a long-time frame following a traumatic injury. This study employs a prospective cohort study design to capture estimates of disability among injured patients using validated instruments at one month, three months, six months, and twelve months following the injury in Pakistan. This study's large sample size increases the accuracy and generalizability of the findings. In this study, we will calculate the injury severity score and revised trauma score, which are important measures of severe injury. Also, we will assess elements like PTSD that could directly impact outcomes related to disabilities.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003eLimitations\u003c/h2\u003e \u003cp\u003eThe study has some limitations. The study will be carried out in two trauma centres with different volumes, patient flow systems, and resource availability. This might not accurately represent the situation in other local trauma centres in the country. Due to practical reasons, we will not include paediatric trauma patients, missing a substantial proportion of the population contributing to the trauma burden. In addition, we will not fully account for the trauma burden (minor injuries, brought dead, and mortalities in the ED) because we will only include admitted patients. However, since we intend to recruit participants with whom we can follow up to learn more about long-term consequences, collecting the whole trauma burden is not the study's objective. Some patients will be missed since there will be only eight to ten hours of data collection per day, six days per week. Patients admitted on Sundays or holidays and those who pass away or leave against medical advice at night are only a few examples. There may be differences between missed and admitted patients, and the generalizability may be limited. The extraction of data from medical records may pose certain challenges. Some of the variables in the medical records might be missing or have inconsistent data. Data entry is dependent on the availability of electricity and high-quality internet. There may be challenges related to telephonic follow-ups. Inaccurate phone numbers, inactive phone numbers, female patients' reluctance to participate, and non-response may pose follow-up barriers.\u003c/p\u003e \u003c/div\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThe high disability burden following accidental trauma imposes a significant burden and cost on individuals and society. Therefore, the trauma registry would fill this gap by capturing post-discharge long-term PROs. It will provide the injured patient's post-discharge situation, challenges, and future directions for incorporating long-term PROs in low-resource settings. Including long-term measures in routine follow-ups will provide insights into physical, social, and policy barriers and help advance injury care research.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003ePROs: Patient-Reported Outcomes\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eED: Emergency Department\u003c/p\u003e\n\u003cp\u003eAIS: Abbreviated Injury Scale\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eISS: Injury Severity Score\u003c/p\u003e\n\u003cp\u003eTRISS: Trauma Score and Injury Severity Score\u003c/p\u003e\n\u003cp\u003eQoL: Quality of Life\u003c/p\u003e\n\u003cp\u003ePTSD: Post-Traumatic Stress Disorder\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was approved by both The AKUH Ethics Review Committee (ERC Reference No. 2021-6251-18973) and the JPMC Institutional Review Board Committee (Reference No. F.2-81/2021-GENL/70586/JPMC).\u003c/p\u003e\n\u003cp\u003eThe study complies with the Declaration of Helsinki.\u0026nbsp;Informed verbal consent was obtained from all the participants before starting data collection. Participation was voluntary, and the right to ask any questions and to decline participation/leave the study at any time was emphasized during the data collection. Data was anonymized during data management, analysis, and reporting.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgement:\u0026nbsp;\u003c/strong\u003eWe are thankful to Seemi Jamali for helping us carry out the study at Jinnah Postgraduate Medical Centre. We also acknowledge Dr Hasnain Zafar for his insightful comments that helped us to finalise the registry variables.\u0026nbsp;We would also like to thank Dr Fatima Bano for helping us develop the registry questionnaires on RedCap.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDisclaimer:\u0026nbsp;\u003c/strong\u003eNone\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflict of interest:\u0026nbsp;\u003c/strong\u003eThe authors have no conflicts of interest to disclose.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding disclosure:\u0026nbsp;\u003c/strong\u003eResearch reported in this publication was supported by the Fogarty International Center of the National Institutes of Health under Award Number D43TW007292 - the Aga Khan University Trauma and injury research training program. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors' contributions:\u0026nbsp;\u003c/strong\u003eNS, AAHM, and JR conceived the idea of this manuscript; NS, AAHM wrote the manuscript; NS, JR, AAH, and AH critically revised the paper and provided valuable feedback. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors Affiliations\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e1\u003c/sup\u003eCentre of Excellence for Trauma and Emergencies, Aga Khan University, Karachi, Pakistan.\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e2\u003c/sup\u003eDepartment of Epidemiology, Robert Stempel College of Public Health \u0026amp; Social Work, Florida International University, USA.\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e2\u003c/sup\u003eMedical College, Aga Khan University, Karachi, Pakistan.\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e3\u003c/sup\u003eDepartment of Emergency Medicine, Aga Khan University Hospital, Karachi, Pakistan.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e4\u003c/sup\u003eDepartment of Neurosurgery, Jinnah Postgraduate Medical Centre, Karachi, Sindh, Pakistan\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e5\u003c/sup\u003eDepartment of Emergency Medicine, Jinnah Postgraduate Medical Centre, Karachi, Sindh, Pakistan.\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e6\u003c/sup\u003eDepartment of Surgery, Jinnah Postgraduate Medical Centre, Karachi, Sindh, Pakistan.\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e7\u003c/sup\u003eMilken Institute School of Public Health, George Washington University, Washington, DC, USA.\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e8\u003c/sup\u003eDepartment of Emergency Medicine, Weill Cornell Medicine, New York, USA.\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e9\u003c/sup\u003eDepartment of Surgery and Community Health Sciences, Aga Khan University, Karachi, Pakistan\u003cstrong\u003e.\u003c/strong\u003e\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003eVizHub - GBD Compare [Internet]. [cited 2022 Oct 1]. Available from: https://vizhub.healthdata.org/gbd-compare/\u003c/li\u003e\n \u003cli\u003eAbbafati C, Abbas KM, Abbasi-Kangevari M, Abd-Allah F, Abdelalim A, Abdollahi M, et al. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet (London, England) [Internet]. 2020 Oct 17 [cited 2022 Oct 1];396(10258):1204\u0026ndash;22. Available from: https://pubmed.ncbi.nlm.nih.gov/33069326/\u003c/li\u003e\n \u003cli\u003eWHO | Death on the roads [Internet]. [cited 2022 Oct 2]. Available from: https://extranet.who.int/roadsafety/death-on-the-roads/#country_or_area/PAK\u003c/li\u003e\n \u003cli\u003eWHO. World health statistics 2018: monitoring health for the SDGs [Internet]. Vol. 7, Pakistan Research Journal of Management Sciences. 2018. Available from: http://content.ebscohost.com/ContentServer.asp?EbscoContent=dGJyMNLe80Sep7Q4y9f3OLCmr1Gep7JSsKy4Sa6WxWXS\u0026amp;ContentCustomer=\u003cbr\u003edGJyMPGptk%2B3rLJNuePfgeyx43zx1%2B6B\u0026amp;T=P\u0026amp;P=AN\u0026amp;S=R\u0026amp;D=buh\u0026amp;K=134748798%0Ahttp://amg.um.dk/~/media/amg/Documents/Policies and Strategies/S\u003c/li\u003e\n \u003cli\u003eShanthakumar D, Payne A, Leitch T, Alfa-Wali M. Trauma Care in Low- and Middle-Income Countries. The Surgery Journal [Internet]. 2021 Oct [cited 2022 Oct 1];7(4):e281. Available from: /pmc/articles/PMC8536645/\u003c/li\u003e\n \u003cli\u003ePop B, Fetica B, Blaga ML, Trifa AP, Achimas-Cadariu P, Vlad CI, et al. The role of medical registries, potential applications and limitations. Medicine and Pharmacy Reports [Internet]. 2019 [cited 2022 Oct 1];92(1):7. Available from: /pmc/articles/PMC6448488/\u003c/li\u003e\n \u003cli\u003eKamp O, Pfeifer R, Ritschel M, Flohe S, Bieler D. Polytrauma outcome: implementation of health-related quality of life assessment into the German Trauma Registry. European Journal of Trauma and Emergency Surgery [Internet]. 2021 Jun 1 [cited 2022 Oct 1];47(3):869\u0026ndash;74. Available from: https://link.springer.com/article/10.1007/s00068-019-01270-7\u003c/li\u003e\n \u003cli\u003eFord JE, Alqahtani AS, Abuzinada SAA, Cameron PA, Fitzgerald MC, Alenizi AS, et al. Experience gained from the implementation of the Saudi TraumA Registry (STAR). BMC Health Services Research. 2020;20(1).\u003c/li\u003e\n \u003cli\u003eTyson AF, Varela C, Cairns BA, Charles AG. Hospital Mortality Following Trauma: An Analysis of a Hospital-Based Injury Surveillance Registry in sub-Saharan Africa. Journal of Surgical Education. 2015 Jul 1;72(4):e66\u0026ndash;72.\u003c/li\u003e\n \u003cli\u003eWilliamson OD, Gabbe BJ, Sutherland AM, Wolfe R, Forbes AB, Cameron PA. Comparing the responsiveness of functional outcome assessment measures for trauma registries. Journal of Trauma - Injury, Infection and Critical Care [Internet]. 2011 Jul [cited 2022 Oct 2];71(1):63\u0026ndash;8. Available from: https://journals.lww.com/jtrauma/Fulltext/2011/07000/Comparing_the_Responsiveness_of_Functional_Outcome.11.aspx\u003c/li\u003e\n \u003cli\u003eRosenkrantz L, Schuurman N, Arenas C, Nicol A, Hameed MS. Maximizing the potential of trauma registries in low-income and middle-income countries. Trauma Surgery \u0026amp; Acute Care Open [Internet]. 2020 May 1 [cited 2022 Oct 1];5(1):e000469. Available from: https://tsaco.bmj.com/content/5/1/e000469\u003c/li\u003e\n \u003cli\u003eRios-Diaz AJ, Herrera-Escobar JP, Lilley EJ, Appelson JR, Gabbe B, Brasel K, et al. Routine inclusion of long-term functional and patient-reported outcomes into trauma registries: The FORTE project. Journal of Trauma and Acute Care Surgery. 2017 Jul 1;83(1):97\u0026ndash;104.\u003c/li\u003e\n \u003cli\u003eRosenkrantz L, Schuurman N, Hameed M. Trauma registry implementation and operation in low and middle income countries: A scoping review. https://doi.org/101080/1744169220191622761 [Internet]. 2019 Dec 2 [cited 2022 Oct 1];14(12):1884\u0026ndash;97. Available from: https://www.tandfonline.com/doi/abs/10.1080/17441692.2019.1622761\u003c/li\u003e\n \u003cli\u003eHyder AA, Razzak JA. The challenges of injuries and trauma in Pakistan: An opportunity for concerted action. Public health [Internet]. 2013 Aug [cited 2022 Sep 23];127(8):699. Available from: /pmc/articles/PMC4313547/\u003c/li\u003e\n \u003cli\u003eTanoli O, Ahmad H, Khan H, Khattak FA, Khan A, Mikhail A, et al. A pilot trauma registry in Peshawar, Pakistan - A roadmap to decreasing the burden of injury - Quality improvement study. Annals of medicine and surgery (2012) [Internet]. 2021 Dec 1 [cited 2022 Oct 1];72. Available from: https://pubmed.ncbi.nlm.nih.gov/34934485/\u003c/li\u003e\n \u003cli\u003eMehmood A, Razzak JA, Kabir S, Mackenzie EJ, Hyder AA. Development and pilot implementation of a locally developed Trauma Registry: lessons learnt in a low-income country [Internet]. 2013. Available from: http://www.biomedcentral.com/1471-227X/13/4\u003c/li\u003e\n \u003cli\u003eAhmad T, Muhammad ZA. Patient outcomes association with patient factors and care provided: trauma registry derived cohort study. Journal of the Pakistan Medical Association. 2020;70(2):S10\u0026ndash;4.\u003c/li\u003e\n \u003cli\u003eHaider AH, Herrera-Escobar JP, Al Rafai SS, Harlow AF, Apoj M, Nehra D, et al. Factors associated with long-term outcomes after injury: Results of the functional outcomes and recovery after trauma emergencies (FORTE) multicenter cohort study. Annals of Surgery. 2020;271(6):1165\u0026ndash;73.\u003c/li\u003e\n \u003cli\u003eNSW Trauma Registry System | Institute of Trauma and Injury Management | ACI [Internet]. [cited 2022 Oct 2]. Available from: https://aci.health.nsw.gov.au/networks/itim/data/nsw_trauma_registry_system\u003c/li\u003e\n \u003cli\u003eOttenbacher KJ, Hsu Y, Granger C V., Fiedler RC. The reliability of the functional independence measure: A quantitative review. Archives of Physical Medicine and Rehabilitation [Internet]. 1996 Dec 1 [cited 2022 Oct 1];77(12):1226\u0026ndash;32. Available from: http://www.archives-pmr.org/article/S0003999396901847/fulltext\u003c/li\u003e\n \u003cli\u003eSmith PM, Illig SB, Fielder RC, Hamilton BB, Ottenbacher KJ. Intermodal agreement of follow-up telephone functional assessment using the functional independence measure in patients with stroke. Archives of Physical Medicine and Rehabilitation [Internet]. 1996 May 1 [cited 2022 Oct 1];77(5):431\u0026ndash;5. Available from: http://www.archives-pmr.org/article/S0003999396900295/fulltext\u003c/li\u003e\n \u003cli\u003eHerrera-Escobar JP, Deroon-Cassini T, Brasel K, Nehra D, Al Rafai SS, Toppo A, et al. Development and validation of a revised trauma-specific quality of life instrument. Journal of Trauma and Acute Care Surgery [Internet]. 2020 Apr 1 [cited 2022 Oct 1];88(4):501\u0026ndash;7. Available from: https://journals.lww.com/jtrauma/Fulltext/2020/04000/Development_and_validation_of_a_revised.5.aspx\u003c/li\u003e\n \u003cli\u003ePrins A, Bovin MJ, Smolenski DJ, Marx BP, Kimerling R, Jenkins-Guarnieri MA, et al. The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5): Development and Evaluation Within a Veteran Primary Care Sample. Journal of general internal medicine [Internet]. 2016 Oct 1 [cited 2022 Oct 1];31(10):1206\u0026ndash;11. Available from: https://pubmed.ncbi.nlm.nih.gov/27170304/\u003c/li\u003e\n \u003cli\u003eCrane S, Comer RS, Arenson AD, Draucker C. Using REDCap to Facilitate Web-Based Therapeutic Intervention Research. Nursing research [Internet]. 2019 Nov 1 [cited 2022 Oct 1];68(6):483\u0026ndash;7. Available from: https://pubmed.ncbi.nlm.nih.gov/31693554/\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"archives-of-public-health","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"aoph","sideBox":"Learn more about [Archives of Public Health](http://archpublichealth.biomedcentral.com/)","snPcode":"13690","submissionUrl":"https://submission.nature.com/new-submission/13690/3","title":"Archives of Public Health","twitterHandle":"@Archpubhealth","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Patient Reported Outcomes, Digital Trauma Registries, Disabilities, low- and middle- income countries","lastPublishedDoi":"10.21203/rs.3.rs-4238506/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4238506/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eObjectives\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePost-discharge patient-reported outcomes from trauma registries can be used to measure trauma care quality. However, studies reflecting the Asian experience are limited. Therefore, we aim to develop a digital trauma registry to prospectively capture patient-reported outcomes (PROs) at one-, three-, six-, and twelve-months post-injury in Pakistan.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe will use a cohort study design to develop a digital trauma registry at two tertiary care facilities (Aga Khan University Hospital \u0026amp; Jinnah Postgraduate Medical Center) in Karachi, Pakistan. The registry will include all admitted adult trauma patients (≥18 years). Data collection will be digital using tablets, with mortality, level of disability, and functional status, quality of life being the outcomes. Telephonic interviews will be conducted with the patients and caregivers for follow-up data collection.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe high disability burden following accidental trauma imposes a significant burden and cost on individuals and society. Therefore, the trauma registry would fill this gap by capturing post-discharge long-term PROs. It will provide the injured patient's post-discharge situation, challenges, and future directions for incorporating long-term PROs in low-resource settings. Including long-term measures in routine follow-ups will provide insights into physical, social, and policy barriers and help advance injury care research.\u003c/p\u003e","manuscriptTitle":"Exploring the Long-Term Disability Outcomes in Trauma Patients: Study Protocol","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-04-10 18:27:30","doi":"10.21203/rs.3.rs-4238506/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-06-19T17:02:33+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-06-18T13:22:56+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"307570667472542362838965079206395570743","date":"2024-06-11T08:40:14+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-05-13T20:32:06+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"296970436059838137615228011997269131700","date":"2024-05-02T15:26:42+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-04-29T19:35:56+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-04-11T13:36:10+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-04-11T13:36:10+00:00","index":"","fulltext":""},{"type":"submitted","content":"Archives of Public Health","date":"2024-04-08T20:37:27+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"archives-of-public-health","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"aoph","sideBox":"Learn more about [Archives of Public Health](http://archpublichealth.biomedcentral.com/)","snPcode":"13690","submissionUrl":"https://submission.nature.com/new-submission/13690/3","title":"Archives of Public Health","twitterHandle":"@Archpubhealth","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"1959262a-c9c4-457e-8a42-ec2f387c8de1","owner":[],"postedDate":"April 10th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2024-10-28T16:00:04+00:00","versionOfRecord":{"articleIdentity":"rs-4238506","link":"https://doi.org/10.1186/s13690-024-01385-3","journal":{"identity":"archives-of-public-health","isVorOnly":false,"title":"Archives of Public Health"},"publishedOn":"2024-10-23 15:57:17","publishedOnDateReadable":"October 23rd, 2024"},"versionCreatedAt":"2024-04-10 18:27:30","video":"","vorDoi":"10.1186/s13690-024-01385-3","vorDoiUrl":"https://doi.org/10.1186/s13690-024-01385-3","workflowStages":[]},"version":"v1","identity":"rs-4238506","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4238506","identity":"rs-4238506","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}