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Study Protocol (Trauma)

This study aims to analyze demographic data of trauma patients at a tertiary hospital in the Philippines over one year. Data on age, gender, injury type, mechanism of injury, and other variables will be collected from medical records to help establish an institutional trauma registry. The registry seeks to improve trauma care, research, and prevention by better defining the characteristics of patients. A retrospective review of approximately 4000 trauma cases from September 2020 to 2021 will analyze trends to inform health policy and emergency preparedness.

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Ardy Antonio MD
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0% found this document useful (0 votes)
188 views17 pages

Study Protocol (Trauma)

This study aims to analyze demographic data of trauma patients at a tertiary hospital in the Philippines over one year. Data on age, gender, injury type, mechanism of injury, and other variables will be collected from medical records to help establish an institutional trauma registry. The registry seeks to improve trauma care, research, and prevention by better defining the characteristics of patients. A retrospective review of approximately 4000 trauma cases from September 2020 to 2021 will analyze trends to inform health policy and emergency preparedness.

Uploaded by

Ardy Antonio MD
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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Republic of the Philippines

Department of Health
Central Luzon Center for Health Development
DR. PAULINO J. GARCIA MEMORIAL RESEARCH
AND MEDICAL CENTER
Cabanatuan City
ISO QMS Certified

DEMOGRAPHICS OF TRAUMA PATIENTS


SEEN AT A TERTIARY GOVERNMENT HOSPITAL IN NUEVA ECIJA:
A RETROSPECTIVE STUDY

Project Leaders:
Arlene Jeremie T. Gan, MD, FPCS, FPSGS
Medical Specialist II

Dulce Grace A. Esposo-Binuya, RMT, MD, FPSGS, FPCS


Medical Officer IV

Co-Project Leader:
Aldryan Antonio, MD
Medical Officer III - Surgical Resident

Dr. PJGMRMC - Department of General Surgery

---
INTRODUCTION Trauma represents the cause of 10% of deaths in the
entire world [3]. The successful development of trauma
Accurate demographic statistics are important to improve systems, including the use of trauma registers and
health policy by serving as a basis for implementing demographics, played a significant part in lowering the
appropriate prevention strategies, improving emergency mortality and the disabilities due to injuries resulted from
preparedness, and instituting intensified security trauma. The predictions show that between 2000 and
adjustments. These data must come from multiple 2020, the deaths caused by road accidents will increase
sources, census and mortality reports, hospital by 83% in less developed countries while in developed
databases and community-based reports in order to countries they will register a continuous decrease by
increase its validity and reduce under-reporting. 30% [4]. The improvements regarding the treatment of
Philippine health statistics for mortality and disability multiply injured trauma patients in developing countries
from trauma injuries are still highly needed [1]. One of the depend on establishing a fully functioning trauma
current challenges for the Department of Health is to system. Trauma demographics offer a way of collecting
consolidate and improve the quality of its data on the and analysing favourable epidemiological data, which
burden of disease from injuries in order to increase the can be used in improving the quality of treatments,
likelihood of meeting its National Objectives of Health. alerting authorities and rescue systems, as well as in
Many of these objectives have not ‘trickled’ down to the future researches.
institutional level, in terms of trauma center accreditation,
research or training. Trauma registries have developed once they were
introduced in centers and trauma systems in the United
Institutionally, Dr. Paulino J. Garcia Memorial Research States of America in 1970 [5]. Their initial purpose was to
and Medical Center (Dr. PJGMRMC) – Department of highlight the epidemiological factor of the trauma [6]. USA
Surgery has been an instrumental in implementing the has 37 states with trauma data registers which include
latest advances in trauma care and being the leader in data regarding patients that are being treated in each of
continuing improvement and education of trauma care specific centers. Recently, the Trauma Committee of
providers not only in Region III but also to different American Surgeon College started National Trauma
trauma rotators coming from Metro Manila, Pampanga, Data Bank (NTDB), a system that gathers prospective
and other neighbouring institutions. However, no recent data from trauma registries and demographic data of the
data from Dr. PJGMRMC is available to describe the centers and systems across United States. NTDB
characteristics of the trauma population, specifically that represents the biggest collection of trauma registries
of the demographics of trauma patients. The purpose of data and holds over one million entries gathered from
this study is to describe the demographic patterns of 405 centers in the USA. Information from the database
these patients catered at our tertiary hospital. has become a powerful tool in developing areas like
epidemiology, injuries control, research, education, acute
care and even in resource allocations [7].
Case selection and exclusion
The provision of organized trauma care is in its infancy in The victims/relatives of the traumatic injury cases,
many parts of the Philippines. Most sources of trauma who are catered on emergency department,
data are coming from Metro Manila and other nearby orthopedic outpatient clinic, surgical outpatient clinic
highly-specialized centers. In contrast to other remote or admitted in the surgical/orthopedic wards, who
trauma centers, like that of Dr. PJGMRMC located in were interviewed to obtain the information about the
Central Luzon, we have yet to analyse demographic circumstances leading to the accident and was
patterns and epidemiology of trauma patients despite a included on hospital’s database. The victims who
significant increase of trauma referrals during the past already arrived as mortality (dead on arrival) were
years. excluded.

OBJECTIVE Data collection


Starting in September 2020 to September 2021, data
General Objective: To gather and interpret a minimal will be collected in a trauma registry and on hospital’s
data set to better define the demographics of traumatic medical records about injured individuals admitted to
injuries catered in Dr. PJGMRMC. Dr. PJGMRMC through the surgical department. The
registry data included age, gender, address, location
Specific Objectives: and time sequence of injury, mode of injury, alcohol
 To analyse these data to be used as a basis and use, injury type(s), and disposition (admitted,
foundation for institutionalized trauma registry. improved, or mortality).
 For these data to serve as an information reservoir
for future researches. DESCRIPTION OF OUTCOME MEASURES
 To be a much needed basis for law enforcements
especially on alcohol-related injuries and medico- Gathered data will be categorized according to patients’
legal cases. general data (age, gender, address, etc.), mode of injury
 To be used as a basis for information dissemination (vehicular crash, mauling, fall, etc.), medicolegal or non-
especially on places with high incidence of trauma. medicolegal case, safety gears used, alcohol-related
traumas, and other variables included on hospital’s
METHODOLOGY present trauma registry.

Place of study SAMPLE SIZE ESTIMATION


This descriptive study will be conducted at Dr.
Paulino J. Garcia Memorial Research and Medical The study population that will be included in the study
Center (Dr. PJGMRMC), a trauma center and tertiary covers those who were attended on the emergency
DOH hospital located in Cabanatuan City, Nueva department of Dr. PJGMRMC from September 2020 to
Ecija, Central Luzon. September 2021. Estimated population size will be
+4000 trauma patients.
Duration and type of study
A descriptive and retrospective 1-year review, DATA ANALYSIS
covering September 2020 to September 2021, was
conducted using an electronic and hard copy of The data that will be collected will be analysed using
patients’ databases. percentages, linear and logarithmic trend and Chi-
square.
Study group
It consisted of all the traumatic injury victims reported ETHICAL CONSIDERATIONS
to Dr. PJGMRMC in the above one year period. Approval for medical record access, review and
analysis was obtained from the Board of Ethics of the
Dr. PJGMRMC. The gathered medical records will be
analysed with confidentiality and will be returned to
medical records accordingly. Those residual hard copies
will be machine-shredded and will either be cross-
shredded, pulped, or pulverized.
SCHEDULE OF ACTIVITIES

Work Plan for September 2021 to September 2022 of 1 year duration:


(Sample Gantt Chart)
Sep Oct Nov Dec Jan Feb March April May June July Aug Sep
2021 2021 2021 2021 2022 2022 2022 2022 2022 2022 2022 2022 2022
Research Phase
Development of
Methodology
Draft of Methodology
Evaluation of
Methodology
Approval of Research
Proposal
Specific Activities
Coordination and
Permission Approval
Data Analysis
Data Interpretation
Research Submission
Expected Output
Interim Reports
Final Report
Information
Dissemination

References:
1. Mock C, Quansah R, Kobusingye O, et al. Trauma care in Africa: the way forward. Afr J Trauma. 2004; 2:53–58.
2. Epidemiology of Injuries at a Tertiary Care Center in Malawi; J. C. Samuel et al.; World J Surg. 2009 September ;
33(9): 1836–1841. doi:10.1007/s00268-009-0113-4
3. Krug EG, Sharma GK, Lozano R. The global burden of injuries. Am J Public Health. 2000;90(4):523-6.
4. Cameron PA, Gabbe BJ, McNeil JJ, Finch CF, Smith KL, Cooper DJ, et al. The trauma registry as a statewide
quality improvement tool. J Trauma. 2005;59(6):1469-76.
5. Nantulya MV, Reich MR. The neglected epidemic: Road traffic injuries in developing countries. BMJ
2002;324:1139-41.
6. Peden M, Scurfied R, Sleet D, Mohan D, Hyder AA, Jarawan E, et al. World Report on Road Traffic Injury
Prevention, WHO, 2004.
7. http://www.pokhara.com. [accessed on 2008 Feb 20]
8. Epidemiology of Injuries at a Tertiary Care Center in Malawi World J Surg. 2009 September ; 33(9): 1836–1841.
doi:10.1007/s00268-009-0113-4

Research Funding: None


Competing Interest: None declared
Aldryan S. Antonio, MD
#58 Brgy. Dalampang, Cabanatuan City, Nueva Ecija
3100 Philippines
[email protected]
+63 999 575 3171

PERSONAL INFORMATION
Address: #58 Purok 2, Brgy. Dalampang, Cabanatuan City, Nueva Ecija
Birthday: September 15, 1990
Age: 31 years old
Birthplace: Cabanatuan City, Nueva Ecija
Civil Status: Single
Nationality: Filipino

EDUCATIONAL ATTAINMENT:

Doctor of Medicine: Saint Louis University - School of Medicine, “Bene Meritus”


Baguio City, Class of 2016

Post-Graduate Internship: Saint Louis University – Hospital of the Sacred Heart, Baguio City, Class of
2017

Undergraduate level: Bachelor of Science in Nursing, Saint Louis University, Baguio City, Class of
2011

Secondary level: Honorato C. Perez Sr. Memorial Science High School, Cabanatuan City,
Nueva Ecija, Class of 2007

Primary level: Araullo University Elementary School, Cabanatuan City, Nueva


Ecija, Class of 2003

LICENSURE / CERTIFICATION:
 Nursing Licensure Examination Board Passer, December 2011
 Physician Licensure Examination Board Passer, September 2017
Board Rating – 82.00%

PUBLICATIONS:
 Interesting Case: “Complete Intestinal Obstruction Resulting from Mesenteric Herniation of Gangrenous Small
Intestine in Dr. Paulino J. Garcia Memorial Research and Medical Center”
 A. Antonio, J. Dumapis et. al. (2010); Defense Mechanism of Elderly on Death of a Loved One
 A. Antonio, K. D. Sayaboc et. al. (2013); The Effect of Yacon (Smallanthus sonchifolius) Extract on Total
Cholesterol Level of Rabbits
CONVENTIONS / POST GRADUATE COURSES ATTENDED:

 Philippine Heart Association, Baguio - Benguet Chapter, Matters of the Heart – A Collaborative Approach,
Notre Dame de Chartres Hospital, February 2018
 Department Of Health, Baguio General Hospital and Medical Center – Department of Radiology, Clinical
Case Discussions in Pediatric Radiology, Baguio Country Club and Training Center, July 2016
 Association of the Philippine Medical Colleges, 48th Annual Convention, Davao City, February 2015
 Association of the Philippine Medical Colleges Student Network, 2014 Regional Convention, Vigan City

MEMBERSHIPS AND ASSOCIATIONS


 Nueva Ecija Medical Society (NEMS) (2019 – Present)
 Rotaract Club of SLU School of Medicine (2012)
 Asian Medical Students Association, SLU School of Medicine (2012-2016)
 Association of Philippine Medical Colleges (APMC)
Statistician Consultation Form

(To the PI: Please fill in the following sections based on the information from the research protocol. This form is a
requirement prior to submission to the RDU for scientific review)

Demographics of Trauma Patients Seen at a Tertiary Government Hospital in


STUDY PROTOCOL TITLE
Nueva Ecija: A Retrospective Study
DATE December 6, 2021
VERSION NUMBER
PROJECT LEADER Arlene Jeremie T. Gan, MD, FPSGS, FPCS
(the research adviser/ consultant supervisor)

CO-PROJECT LEADER
(the resident, fellow or researcher serving as the principal Aldryan S. Antonio, MD
investigator)

OTHER MEMBERS OF THE


Joan Tamangan-Satorre, MD, FPSGS
RESEARCH TEAM
DEPARTMENT/UNIT Department of General Surgery
DEPARTMENT TECHNICAL
REVIEWER
(technical reviewer within the PI’s department/unit)

Particulars Comments
Research question(s) and/or hypotheses; objectives The specific objectives are not specific enough to define
Was the PI able to identify and explain the general research topic (or scope of a scope on what exactly are the traumatic injury data to
study) or the questions needed to be answered in the analysis?
be collected by the researcher/s. The researcher/s
failed to establish how the study will aim to “better
define” the demographics of traumatic injuries in Dr.
PJGMRMC – assuming it was defined differently before
the study is conducted. It is also better to specify the
analyses in the objectives instead of the vague “to
analyze these data” which does not answer nor specify
any direct research question that may have motivated
the study.
Variables to be used in the main analysis Variables/parameters to be measured/collected weren’t
Was the PI able to include adequate information regarding the main specified completely in the protocol.
exposure, outcome, and stratifying variables? List at least 2 to 4 outcomes
and exposure variables (if applicable)

Statistical Methodology and Design The methodology is clear in its definition of the study
Is the research design appropriate? (For clinical trials or experiments with limitations (i.e., target group, duration) but not in the
specimen handling: review of specimen storage, access, disposal, and terms of
use, adequacy of qualified staff and infrastructure, and suitability of the study actual actions/procedures on how the study aims to
site.) achieve its objectives.

Sample Size Determination and Sampling Design There was no discussion on the sampling design and
Is the sampling design suitable and the sample size achievable? (For clinical sample size computation but only a description of the
trials or experiments, is the randomization plan and recruitment strategy
thoroughly discussed?) target population and its estimate population size, in
which the estimation process was also left out. If the
study aims to collect data from the whole population (a
census), then no sampling design is needed.
Statistical analysis plan (SAP) Data analysis methods mentioned were generic and
Are the identified statistical tools, software, and analysis to be used correctly unclear of how they will be utilized in order to
discussed in order to accurately summarize and present the research data?
accomplish the research objectives. It is preferred that
the statistical/data analytical methods and tools were
completely specified in line with each of the research
objectives and the statistical methodology.
Key table shells/dummy tables No dummy tables were included in the study protocol.
Is the plan of data presentation sufficient, balanced, accurate and supportive of
inference or themes?
Overall Recommendations 1. Phrase research objectives as concrete actionable
and measurable targets that provides better
understanding on the scope of the study.

Some Example/s:

To establish/develop/assemble a database/data
bank of trauma registry data in Dr. PJGMRC.

To establish the profile/To describe the socio-


demographic characteristics of victims and relatives
of traumatic injury cases

To identify factors affecting mortality rate of victims


of traumatic injury cases.

2. Completely specify the following:


a. Parameters to be collected or measured
b. Methodologies/procedures/data analysis
necessary in achieving the research
objectives
c. Sampling design, if there is any

Name and Signature of Statistician: NEFRIEND M. FRANCISCO


Date of Consultation: December 7, 2021

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