research final (1)
research final (1)
research final (1)
RESEARCH PROPOSAL
Submitted By
Mr. M.H.M.T.U. WEERASEKARA (EU/IS/2016/MED/16)
Mr. W.A.U.S. NADEESHAN (EU/IS/2016/MED/24)
Miss. B.A.S.K. AMARADASA (EU/IS/2016/MED/50)
Miss. D.M.B.P. DISANAYAKA (EU/IS/2016/MED/72)
This research proposal was submitted to The Department of Primary Health Care, Faculty of
Health Care Sciences, as a part of the Phase II Part 2 curriculum.
Contents
1. INTRODUCTION .................................................................................................................................. 3
1.1 Background....................................................................................................................................... 3
1.2 Justification....................................................................................................................................... 5
1.3 Literature review .............................................................................................................................. 6
1.4 Objectives ........................................................................................................................................ 10
1.4.1. General objective .................................................................................................................... 10
1.4.2. Specific objectives ................................................................................................................... 10
2. METHODOLOGY ............................................................................................................................... 11
2.1 Study design .................................................................................................................................... 11
2.2 Study setting ................................................................................................................................... 11
2.3 Study period.................................................................................................................................... 11
2.4 Study population ............................................................................................................................ 11
2.5 Inclusion criteria ............................................................................................................................ 11
2.6 Exclusion criteria ........................................................................................................................... 11
2.7 Study Instrument ........................................................................................................................... 11
2.8 Sample size ...................................................................................................................................... 12
2.9 Data collection ................................................................................................................................ 12
2.10 Data analysis ................................................................................................................................. 13
2.11 Ethical review ............................................................................................................................... 14
2.12 Maintenance and disposal of data ............................................................................................... 14
3. TIME FRAME ..................................................................................................................................... 15
4. REFERENCES ..................................................................................................................................... 16
5. BUDGET ............................................................................................................................................... 17
Annex 1 ................................................................................................................................................. 18
Annex 2 ................................................................................................................................................. 19
PART 1 .............................................................................................................................................. 19
PART 2 .............................................................................................................................................. 20
Annex 3 ................................................................................................................................................. 21
PART 1 - 1 ........................................................................................................................................ 21
PART 1 - 2 ........................................................................................................................................ 26
PART 2 .............................................................................................................................................. 31
PART 3 .............................................................................................................................................. 32
1. INTRODUCTION
1.1 Background
Antibiotics are substances produced by microorganisms, which selectively suppress the growth
of or kill other microorganisms at lower concentration. (Tripathi, 2018)
Usually, the immune system prevents the multiplication and ability of causing a disease of a
microbe that enters the body by attacking against it and killing it. Even though symptoms appear,
immune system often can handle the infection. But if the number of microbes is excessive the
immune system needs a support to fight against the microbes. In that case antibiotics can be
used.
Although this is a magical medication which helps human body to act against infections, it can
cause for several problems such as collateral damage, toxicity, hypersensitivity, drug resistance
and super infections.
The growing concern about antibiotics resistance has prompted several supranational and
domestic political responses. World Health Organization (WHO) has formulated a ‘Global
Action Plan on Antibiotic Resistance’ and regularly issues updates, fact sheets on the issues.
Also, other organizations such as ‘Global Antibiotic Resistant Partnership (GARP) have been
monitoring the emergence of resistant strains around world since 2009 and advising on local
treatment strategies.(Rang - Rang & Dale’s, n.d.) There have been domestic initiatives too.
In the United States, a national action plan was announced in 2015 and many other countries
have introduced similar strategies to implement the advice arising from the WHO, GARP and
other organizations.(Rang - Rang & Dale’s, n.d.) Developing countries often struggle to introduce
such measures. Because of that they typically burdened with lack of access to drugs, poor
hygiene, and infection control.(Rang - Rang & Dale’s, n.d.)
In Sri Lanka, there is a National Strategic Plan (NSP) 2017-2022 which guide to combat
antimicrobial resistance this strategy is developed under five key strategies simultaneous with the
objectives of the Global Action Plan. Those are as follows:
The reason that drew our attention towards the study on practices of antibiotic prescription
among doctors in medical and surgical wards of Teaching Hospital Batticaloa is, the
observations made by us regarding the switching of empiric to targeted antibiotic therapy was
not happened on several occasions in the wards of Teaching Hospital Batticaloa during our
clinical clerkships. We chose the Teaching Hospital Batticaloa as it is the largest tertiary care
center in the region as well as we chose the medical and surgical wards as our study setting,
because of the huge percentage of total antibiotic prescriptions are taking place there. The
outcome of this study is to identify the challenges faced by the doctors in antibiotic prescription
as well as in switching from empiric to targeted antibiotic therapy. Therefore, we wanted to find
out what are the factors affecting antibiotic prescription in our study area. These findings will be
useful for hospital as well as public health team to implement appropriate measures to prevent
antimicrobial resistance.
1.3 Literature review
In relevance to our topic on practices of antibiotic prescription among doctors in medicine and
surgery wards of Teaching Hospital Batticaloa; we studied many researches that focused on
similar aspects.
Guidelines are developed to improve the outcome of an infectious disease using relevant
antimicrobial therapy and to reduce the resistance to antimicrobial agents. Guidelines play a
specific role in knowing the appropriate time of commencing the treatment, selecting relevant
treatment regimens and dose adjustments.(Empirical and Prophylactic Use of Antimicrobials National
Guidelines 2016, n.d.)
A study was conducted on antibiotic prescribing in primary care, adherence to guidelines and
unnecessary prescribing in Ireland by M Murphy, CP Bradley, and S Byrne in 2019. The aim of
the research was to find out the types of antibiotics and the occasions in primary care where the
general practitioners felt that prescription of antibiotics was a necessity while clerking the
patients. Data was collected from 171 general practitioners on 16,899 consultations. From these
consultations, an antibiotic was prescribed for 20.16%. The study concludes that considerable
inappropriate prescription of antibiotics occurs among adults and the rate of using broad
spectrum antibiotics is also high. (Murphy et al., 2012)
A case report was published on 12 November 2007 on adherence to guidelines for antibiotic
prophylaxis in general surgery. It was done to assess the adherence to guidelines by general
surgeons in antimicrobial prophylaxis. 898 patients who were to be operated were elected and
out of them 44.8% undergone a clean surgical operation and 55.2% undergone a clean-
contaminated surgical operation. And it is mentioned that, though only 78.5% cases required
prophylaxis; it was given for 97.5% of cases. So, it is revealed that for 19% 0f cases prophylaxis
antibiotics were given inappropriately. The study concludes that, adherence to guidelines in
surgical prophylaxis should be developed and interventions must be done for the development,
distribution, and adaptation to guidelines with the surgeons. (Tourmousoglou et al., 2007)
A retrospective study was conducted on adherence to guidelines on antibiotic treatment for
respiratory tract infections in various categories of physicians. The aim of the study was to get to
know about the differences in perception of prescribing antibiotics for respiratory tract infections
among interns, residents, younger general practitioners, older general practitioners, and locums.
Data was collected from 53 health centers and 3 out of hours’ units in Sweden through their
common electronic medical record database. All physicians working in primary care during 1
November 2010 to 31 October 2012 were participated for the study. Physician’s adherence to
current guidelines in prescribing antibiotics for respiratory tract infections is measured as the
outcome of the study. It is found that significant differences in prescribing practices among
various physician groups. Guidelines are followed by interns and residents most often and the
compliance in descending order was younger general practitioners, older general practitioners,
and locums. As the conclusion of the study, national guidelines are followed by primary care
general practitioners while treating respiratory tract infections in children but to a lesser degree
when treating adults. (Tell et al., 2015)
A case report was published on 26 July 2010 regarding factors influencing primary care
physicians to prescribe antibiotics in Delhi India. The aim of the study was to evaluate the
perception of physicians on the practices of antibiotic prescription to make interventions to
improve the rational use of antibiotics. The perspectives of primary care physicians in the
government and private sectors in five municipal wards of Delhi were evaluated using focus
group discussions on antibiotic usage and resistance. Three main themes were recognized as
results of the study: the practices and habits of doctors and patients, the negligence in regulating
the prescription and dispensing of antibiotics and lack of interventional strategies in improper
usage of antibiotics, and resistance to antibiotics. As a conclusion, the perception, and practices
of antibiotic usage among physicians were explored and possible interventions that assist in
rational usage of antibiotics to avoid antibiotic resistance was evaluated. (Kotwani et al., 2010)
A prospective, randomized study was conducted to compare empirical treatment versus targeted
treatment based on the urine antigen results in hospitalized patients with community acquired
pneumonia. The target of the study was to identify the effect of a therapeutic strategy based on
the microbiological results provided by urinary antigen tests for Streptococcus pneumoniae and
Legionella pneumophila. 194 patients were enrolled in this study and out of them; 177 were
available for randomization, 89 were allocated to empirical treatment and 88 were allocated to
targeted treatment. This study concludes that; narrowing the antibiotic therapy according to the
urine antigen results can be associated with an increased risk of clinical relapse. (Falguera et al.,
2010)
A retrospective study was conducted on adjustment of antibiotic treatment according to the
results of blood cultures leads to decreased antibiotic use and costs. The aim of the study was to
avoid the inappropriate use of broad-spectrum antibiotics. The study assisted to explore that the
reports of blood cultures led to changes in antibiotic use and costs in a tertiary – care university
hospital in Norway. In here, an analysis was done about the antibiotic usage in 226 episodes of
bacteremia in 214 patients. According to the guidelines, in 166 episodes, the empirical antibiotic
therapy should be modified. Usage of antibiotics was modified in 146 (88%) out of these 166
episodes, which brought to a narrowing of antibiotic treatment therapy in 118 (80%) episodes.
When comparing with empirical therapy, there was a 22% deduction in the number of
antibiotics. It concluded; modification of antibiotic therapy according to the results of blood
cultures brought to a deduction in the number of antibiotics and a narrowing of antibiotic
treatment therapy. And the expenditure for antibiotics also decreased. (Berild et al., 2006)
A single center cohort study was done from 1996 to 2010 with a follow-up of 2 years on “No
need for broad-spectrum empiric antibiotic coverage after surgical drainage of orthopedic
implant infections”. The study had been done due to a common practice of commencing empiric
broad-spectrum antibiotic therapy for orthopedic implant infections after surgical lavage where
there is a lack of evidence. 342 implant infections were retrieved and followed up for a median
of 3.5 years. The median duration of the coverage of empiric antibiotic therapy after surgical
drainage was three days before switching to targeted therapy. The study concluded that, the
remission of orthopedic implant infections within first three days is not amplified by the
coverage of broad-spectrum antibiotic therapy.(Schindler et al., 2013)
1.4 Objectives
Doctors in medical and surgical wards of Teaching hospital Batticaloa who provide
Doctors in medical and surgical wards of Teaching Hospital Batticaloa who are willing to
participate in the study
Total population = Number of doctors attached to the medical and surgical wards
of Teaching Hospital Batticaloa
= 80
Permission to collect data will be obtained from the Director, Teaching Hospital
Batticaloa.
Before commencing data collection, ethical clearance will be obtained from Ethics
Review committee of FHCS.
Doctors attached to the medical and surgical wards of Teaching Hospital Batticaloa will
be informed about the study and their email addresses will be collected.
Questionnaire will be distributed by the researchers to every doctor who attached to the
medical and surgical wards of THB via emails.
Anonymity of the participants will be preserved during and after the process of data
collection.
Data will be analyzed by using the latest version of the recommended statistical
evaluation software SPSS.
Permission for conducting the research will be obtained from Department of Primary
Health Care, Faculty of Health Care Sciences, and will be discussed with the supervisor.
The proposal will be submitted to ethical review committee of Faculty of Health Care
Sciences to obtain ethical clearance. Permission for data collection will be obtained from
the Director, Teaching Hospital Batticaloa. Informed consent from each doctor will be
obtained before the data collection.
The collected data will only be disclosed to the researchers for the study purposes. The
processing and analysis will be carried out only by the researchers. The collected data
will be discarded upon completion of the research.
3. TIME FRAME
Year 2022
Activity 2022
Mar April May June July Aug Sept Oct Nov
Data collection
Data entry
Data analysis
Report writing
Submission
4. REFERENCES
Berild, D., Mohseni, A., Diep, L. M., Jensenius, M., & Ringertz, S. H. (2006). Adjustment of antibiotic
treatment according to the results of blood cultures leads to decreased antibiotic use and costs.
Journal of Antimicrobial Chemotherapy, 57(2), 326–330. https://doi.org/10.1093/jac/dki463
Charani, E., Castro-Sanchez, E., Sevdalis, N., Kyratsis, Y., Drumright, L., Shah, N., & Holmes, A. (2013).
Understanding the Determinants of Antimicrobial Prescribing Within Hospitals: The Role of
“Prescribing Etiquette.” Clinical Infectious Diseases, 57(2), 188–196.
https://doi.org/10.1093/cid/cit212
Falguera, M., Ruiz-Gonzalez, A., Schoenenberger, J. A., Touzon, C., Gazquez, I., Galindo, C., & Porcel, J.
M. (2010). Prospective, randomised study to compare empirical treatment versus targeted
treatment on the basis of the urine antigen results in hospitalised patients with community-
acquired pneumonia. Thorax, 65(2), 101–106. https://doi.org/10.1136/thx.2009.118588
Kotwani, A., Wattal, C., Katewa, S., Joshi, P. C., & Holloway, K. (2010). Factors influencing primary care
physicians to prescribe antibiotics in Delhi India. Family Practice, 27(6), 684–690.
https://doi.org/10.1093/fampra/cmq059
Murphy, M., Bradley, C. P., & Byrne, S. (2012). Antibiotic prescribing in primary care, adherence to
guidelines and unnecessary prescribing - an Irish perspective. BMC Family Practice, 13(1), 43.
https://doi.org/10.1186/1471-2296-13-43
National Strategic Plan for Combating Antimicrobial Resistance in Sri Lanka. (2017).
Reynolds, L., & McKee, M. (2009). Factors influencing antibiotic prescribing in China: An exploratory
analysis. Health Policy, 90(1), 32–36. https://doi.org/10.1016/j.healthpol.2008.09.002
Schindler, M., Gamulin, A., Belaieff, W., Francescato, M., Bonvin, A., Graf, V., Hoffmeyer, P., Wyssa, B., &
Uçkay, I. (2013). No need for broad-spectrum empirical antibiotic coverage after surgical drainage
of orthopaedic implant infections. International Orthopaedics, 37(10), 2025–2030.
https://doi.org/10.1007/s00264-013-1924-3
Tell, D., Engström, S., & Mölstad, S. (2015). Adherence to guidelines on antibiotic treatment for
respiratory tract infections in various categories of physicians: a retrospective cross-sectional study
of data from electronic patient records. BMJ Open, 5(7), e008096.
https://doi.org/10.1136/bmjopen-2015-008096
Tourmousoglou, C. E., Yiannakopoulou, E. Ch., Kalapothaki, V., Bramis, J., & Papadopoulos, J. st. (2007).
Adherence to guidelines for antibiotic prophylaxis in general surgery: a critical appraisal. Journal of
Antimicrobial Chemotherapy, 61(1), 214–218. https://doi.org/10.1093/jac/dkm406
5. BUDGET
The Chairperson,
Ethics Review Committee,
Faculty of Health-Care
Sciences,
Eastern University, Sri Lanka.
Dear sir/Madam,
I, Dr. V. R. Francis hereby express my willingness to supervise the research carried out by
M.H.M.T.U. Weerasekara (EU/IS/2016/MED/16), W.A.U.S. Nadeeshan (EU/IS/2016/MED/24),
B.A.S.K. Amaradasa (EU/IS/2016/MED/50) and D.M.B.P. Disanayaka (EU/IS/2016/MED/72)
of 12th batch Medicine in Faculty of Health Care Sciences, Eastern University, Sri Lanka under
the topic of “A study on practices of antibiotic prescription among doctors in medical and
surgical wards of Teaching hospital Batticaloa” as a partial fulfillment of their degree program. I
will support them throughout the study.
Thank you,
Yours’ sincerely
…………………………………………
Dr. V. R. Francis.
Annex 2
PART 1
INFORMATION SHEET
We are fourth year medical students from Faculty of Health-Care Sciences, Eastern University,
Sri Lanka. We would like to invite you to take part in the research titled “ A study on practices
of antibiotic prescription among doctors in medical and surgical wards of Teaching
Hospital Batticaloa” conducted by Mr. M.H.M.T.U.Weerasekara (EU/IS/2016/MED/16), Mr.
W.A.U.S.Nadeeshan (EU/IS/2016/MED/24), Miss. B.A.S.K.Amaradasa (EU/IS/2016/MED/50)
and Miss. D.M.B.P.Disanayaka (EU/IS/2016/MED/72) at Teaching Hospital Batticaloa. Purpose
of the study is to study on perception of antibiotic prescription and practices among doctors in
medical and surgical wards of Teaching Hospital Batticaloa. In this respect your participation is
highly appreciated. Responding the questionnaire will take about 15 min.
Your participation in this study is voluntary. There will be no interruption to usual activities.
You are always free to ask questions and clarify any queries regarding the study from the
members of the research team.
Confidentiality of data will be maintained, and all the members of the research team will be able
to access the data. Participant’s anonymity will be preserved throughout the study and
afterwards.
Thank you.
If you have any questions regarding this research, please contact the research team.
Yes
No
Annex 3
PART 1 - 1
A study on practices of antibiotic prescription among doctors in medical and
surgical wards of Teaching Hospital Batticaloa
Objectives
General objective-
• To describe the practices of antibiotic prescription among doctors in medical and
surgical wards of Teaching Hospital Batticaloa
Specific objectives-
• To describe the usage of antibiotic guidelines by the doctors
• To identify the factors affecting antibiotic prescription among the doctors
• To identify the challenges in switching from empiric to targeted antibiotic therapy
Annex 3
PART 1 - 2
A study on practices of antibiotic prescription among doctors in medical and
surgical wards of Teaching Hospital Batticaloa
Objectives
General objective-
• To describe the practices of antibiotic prescription among doctors in medical and
surgical wards of Teaching Hospital Batticaloa
Specific objectives-
• To describe the usage of antibiotic guidelines by the doctors
• To identify the factors affecting antibiotic prescription among the doctors
• To identify the challenges in switching from empiric to targeted antibiotic therapy
Q3 Designation
1) Consultant
2) Senior registrar
3) Registrar
4) Senior house office X
5) Relief house officer
6) House officer
Q4 Years of practice X
Q5 Work unit
1) Medical unit
2) Surgical unit X
Q9 If not, why?
1) Guidelines are not available in the ward
2) I like to rely on my clinical experience X
3) I prescribe according to my senior’s advice
4) I prescribe according to availability of
drugs
………………………………………………………………………………………………………………………………………………………………….
02)Gender
1) Male
2) Female
03)Designation
1) Consultant
2) Senior registrar
3) Registrar
4) Senior house office
5) Relief house officer
6) House officer
04)Years of practice
……………………………………………………………………………………………………..
05)Work unit
1) Medical unit
2) Surgical unit
11)If you are following a guideline which guideline are you using?
1) National guideline
2) Hospital guideline
3) International guideline
12)If you are using an international guideline, please name the guideline here.
……………………………………………………………………………………………………..
13)Do you see any differences in antibiotic prescription in government hospitals vs private
sector?
1) Yes
2) No
3) May be
14)What differences do you see in the antibiotic prescription in government sector?
1) Patients influence to shorten the duration of hospital stay
2) To discharge patients quickly due to inadequate ward space
3) Inability to assess renal and liver functions before prescribing
antibiotics in clinic setting
15)If you see any other differences in the antibiotic prescription in government sector, please
Specify here.
………………………………………………………………………………………………………
16) What differences do you see in the antibiotic prescription in private sector?
17) If you see any other differences in the antibiotic prescription in the private sector, please
specify here.
……………………………………………………………………………………………………..
18) Do you request bacterial cultures before starting empiric antibiotic therapy?
1) Always
2) Frequently
3) Occasionally
4) Rarely
5) Never.
19) what are the challenges do you face in requesting cultures before starting empiric
antibiotics?
20) If you face any other challenges which are not listed above, please specify here.
…………………………………………………………………………………………………
21) Are you shifting from the empiric therapy to targeted therapy according to the culture
reports?
1) Yes
2) No
22) What are the challenges do you face in shifting from empiric to targeted therapy?
1) Culture reports are not available on time
2) Patients may be still ill even with broad spectrum empiric therapy
3) Focus of infection may not be identified
4) Culture reports may reveal contamination
23) If you face any other challenges in shifting from empiric to targeted therapy, please specify
here.
……………………………………………………………………………………………………..
24) Do you like to shift from empiric to targeted antibiotic therapy according to culture results if
the patient clinically responds well with empiric therapy?
1) Yes
2) No
3) Maybe
25) Do you check the duration of antibiotic therapy as a routine during the ward rounds?
1) Yes
2) No
3) Maybe
26) Do you trace the culture reports of patients who are on empiric antibiotic therapy during
your ward rounds?
1) Yes
2) No
3) Maybe
Medical students,
12th batch,
Faculty of Health-Care Sciences,
Eastern University-Sri Lanka
2022/05/02
Director,
Teaching Hospital Batticaloa.
Through:
Dean,
Faculty of Health-Care Sciences, EUSL.
Through:
Head,
Department of Primary Health Care,
Faculty of Health-Care Sciences, EUSL.
Dear madam,
Requesting permission to collect data from doctors in medical and surgical wards of
Teaching Hospital Batticaloa
We, the 12th batch medical students, who are conducting research under the topic of “A study on
practices of antibiotic prescription among doctors in medical and surgical wards of
Teaching Hospital Batticaloa “
As we choose all the medical and surgical wards of Teaching Hospital Batticaloa for our
research, we kindly request you to grant permission to collect data from those wards.
We highly appreciate your kind co-operation regarding the above request.
Thank you.
Your sincerely,
Mr. M.H.M.T.U Weerasekara (EU/IS/2016/MED/16) .....................
Mr. W.A.U.S Nadeeshan (EU/IS/2016/MED/25) .....................
Miss. B.A.S.K Amaradasa (EU/IS/2016/MED/50) .....................
Miss. D.M.B.P Disanayaka (EU/IS/2016/MED/72) .....................