Compliance of antibiotic prophylaxis therapy with clinical protocols at the
National Research Center of
Oncology and Transplantology in Astana: retrospective cohort study
MPH candidate: Raushan Bizhigitova
Nazarbayev University School of Medicine
Master of Public Health Program
Antibiotic prophylaxis therapy
Antibiotic prophylaxis therapy – a crucial procedure before undergoing any surgical interventions that is used to decrease the occurrence of
surgical site infections and, thus, minimize postoperative morbidity, mortality and reduce hospitalization time.
• Key components of Antibiotic prophylaxis therapy
→ Appropriate antibiotic drug
→ Correctly defined time and dosages of antibiotic therapy
→ Preoperative and postoperative antibiotic administration
(Page, 1993)
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Consequences of inappropriate antibiotic prophylaxis therapy
• Inappropriate use of antibiotics before surgery might lead to:
→ development of surgical site infections
→ occurrence of medication errors. (Bratzler et al., 2005)
• Surgical site infection accounts for 22% of hospital-acquired infections in USA that is associated with increased morbidity, mortality,
readmissions, and prolonged hospital stay (Jonge et al., 2017) .
• Each year at least 1.3 million people have postoperative complications
due to medication errors in USA (WHO, 2017) .
Intervention
• Republican center for Health development (RCHD, 2016)
→ develop clinical protocols with detailed instructions for antibiotic use in various diseases based on best world practices
• World Health Organization (WHO, 2007)
→ evidence-based guidelines of safe antibiotic administration for patients that need surgical interventions
→ surgical safety checklist
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Key criteria to assess compliance of Antibiotic prophylaxis therapy
(1) Antibiotic introduction to patient prior to and
after surgical intervention
(2) Correct
antibiotic dosage for first dose
(3) Time of
administration of the first dose (between
30 and 60 minutes before surgery)
(4) Correct
antibiotic dosage for second dose
(5) Time of
administration of the second dose
(between 8 and 24
hours after surgery)
Importance of the study
• Occurrence of surgical site infections due to incorrect antibiotic therapy is high (Jonge et al., 2017).
• Reported number of verbally given prescriptions of antibiotic to nurses and number of undocumented antibiotic administration among health professionals (Committee on Patient Safety and Quality Improvement, 2010)
• Limited studies on the problem of compliance of antibiotic prophylaxis therapy with clinical protocols
→ No similar studies published in Kazakhstan
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1. To identify the level of compliance of antibiotic
prophylaxis with clinical protocols and guidelines in National Research Center of Oncology and
Transplantology within 2015-2017
2. To highlight the role of the clinical protocols in providing correct antibiotic prophylaxis
Study objectives
• Retrospective cohort study (January 2015 – December 2017)
• Approved by the research ethical committee of
Nazarbayev University School of Medicine and ethical committee of University Medical Center.
Study Design
• Inclusion criteria: patients elder than 18 years old
receiving antibiotics before and after surgery between 2015 and 2017 in the Department of orthopedics
• Exclusion criteria: incomplete medical records Study
population
• 180 medical records were analyzed
• Examining doctor’s prescriptions, drugs/procedures appointment sheet, surgical and anesthesiology
records and preoperative checklist Sample Size
Data Collection
Methods (1)
• Key criteria of compliance of Antibiotic prophylaxis therapy with clinical protocols:
• Antibiotic introduction prior to and after the surgery
• Correct time and dose of antibiotic prior to and after the surgery
Study Instrument
• Age, gender, type, dose and time of antibiotics
• The level of compliance of Antibiotic
prophylaxis therapy with clinical protocols and WHO guidelines
Independent Variables
Outcome Variable
• Univariate, Bivariate (Chi-square test)
• Statistical significance p-value <0.05
• Stata software (StataCorp, 2013)
Statistical Analysis
Methods (2)
Results: Socio-demographic characteristics
26%
52%
22%
Disease
Coxarthrosis (hip joint disease)
Gonarthrosis (knee joint disease)
Other
7% 11%
32%
50%
Age
18-29 30-44 45-59 60<
30%
70%
Gender
Male Female
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Compliance of Antibiotic prophylaxis therapy with Clinical protocols and guidelines
Criterion No.
available
Compliance No. of compliant
medical records % 95% CI
1. Compliance of chosen antibiotic 180 153 85.0 82.9-95.9
2. Correct time of administration of the first dose
3. Correct antibiotic dosage for the first dose
4. Correct time of administration of the second dose
5. Correct antibiotic dosage for the second dose
180 180 180 180
76 152 142 163
42.2
84.4 78.9 90.6
34.9-49.5 79.1-89.8 72.9-84.9 86.2-94.9 Total duration of antibiotic prophylaxis ≤
24 hours
180 170 94.4 91.1-97.8
Full compliance * 180 58 32.2 25.3-39.1
Compliance of Antibiotic prophylaxis therapy with Clinical protocols and guidelines in 2015-2017
Actions
2015 (n = 60) 2016 (n = 60) 2017 (n = 60)
C NC p C NC p C NC P
Antibiotic
Cefazolin 15 36
0.294
15 30
0.024
25 25
0.014
Ceftriaxone 1 2 2 1 0 0
Lincomycin 0 0 0 0 0 1
No antibiotic agent 0 6 0 12 0 9
First dose
Intraoperative administration 0 2
< 0.001
0 5
< 0.001
0 6
< 0.001
Preoperative administration, < 30 min 0 5 0 9 0 10
Preoperative administration, 30-60 min 16 3 17 9 25 5
Preoperative administration, > 60 min 0 26 0 0 0 0
No antibiotic prophylaxis 0 8 0 20 0 14
Second dose
Postoperative administration, < 8 h 0 5
0.578
0 0
0.002
0 0
0.417
Postoperative administration, 8-24 h 16 34 17 25 25 25
Postoperative administration, > 24 h 0 0 0 0 0 2
No antibiotic prophylaxis 0 5 0 18 0 8
* C – compliant, NC – not compliant
12Full compliance of Antibiotic prophylaxis therapy with clinical protocols and guidelines by year
Full compliance No. available % of compliant medical records
95% CI P
By year 2015 2016 2017
60 60 60
26.67 (16) 28.33 (17) 41.67 (25)
0.151-0.382 0.166-0.401 0.288-0.545
0.156
Discussion
• Most compliant criteria – “Dosages of preoperative and postoperative antibiotic
administration”
• Least compliant criterion – “Time of preoperative antibiotic administration”
→ Preoperative antibiotic prophylaxis therapy improves patient`s condition (Vries et al., 2010)
→ Preoperative antibiotic prophylaxis therapy has significant effect on reducing Surgical site infections (Giusti et al., 2016)
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26.7%
28.3%
41.7%
2015 2016 2017
Full compliance of Antibiotic prophylaxis therapy by year
Discussion
• Introduction of updated surgical checklist in November, 2016 at the
National Research Center of Oncology and Transplantology based
on physician feedback, occurrence of patient readmission and
Discussion
85.0% 84.4%
42.2%
32.2%
15,00%
71.0%
98.0%
80.0%
53.0%
5,00%
Correctly chosen Antibiotic
Correct dose of the first antibiotic administration
Correct time of the first antibiotic administration
Full compliance of antibiotic prophylaxis
therapy
No antibiotic prophylaxis therapy
received
Level of Compliance of Antibiotic Prophylaxis Therapy with Clinical protocols: Kazakhstan vs France
Kazakhstan France
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Needs Attention!
(Bedouch et al., 2004)
Discussion: Strengths
• Study findings allow us:
→ to see the situation in hospitals
→ to increase the awareness of anesthesiologists on Antibiotic prophylaxis therapy compliance
→ to improve adherence to safety guidelines which is required by many accreditation services
→ to monitor the compliance of Antibiotic prophylaxis
therapy procedures with WHO guidelines and Clinical protocols
Discussion: Weaknesses
• Quality of dataset
→ unclear handwritten documentation about antibiotic use
• Small sample size
→ 180 medical records were analyzed instead of expected 300 medical records
• Data is limited to only one hospital
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Discussion: Recommendations
• The study can be expanded to all departments of the center to compare the level of compliance with Clinical protocols
among National Research Center of Oncology and Transplantology departments.
• Mixed method study can be conducted which will include qualitative interviews of anesthesiologists, surgeons and nurses and quantitative analysis of medical records of
patients.
Соблюдение антибиотикопрофилактики согласно клиническим протоколам в
Национальном научном центре онкологии и трансплантологии в г. Астана:
ретроспективное когортное исследование
Кандидат МРН: Раушан Бижигитова
Научный руководитель: Алпамыс Исанов, MD, MPH
Школа Медицины Назарбаев Университета
Программа Общественного Здравоохранения
Введение
Антибиотикопрофилактика – процедура, используемая перед каким- либо хирургическим вмешательством для уменьшения числа
хирургических инфекций, сокращения послеоперационной
заболеваемости, смертности и времени госпитализации. (Page, 1993)
• Клинические протоколы и методические рекомендации на основе
лучших мировых практик с подробным описанием по применению
антибиотиков при различных заболеваниях помогают снизить риск
распространения хирургических инфекций (RCHD, 2016; WHO, 2007)
Ключевые критерии для оценки соответствия антибиотикопрофилактики клиническим
протоколам
(1) Введение
антибиотика пациенту до и после
хирургического вмешательства
(2) Правильная дозировка антибиотиков до
операции
(3) Правильное время введения
антибиотиков до операции (в период между 30-60 мин до
операции)
(4) Правильная
дозировка антибиотиков после операции
(5) Правильное время введения антибиотиков после операции (в период
между 8-24 ч после операции)
(ВОЗ, 2007)
221. Определить уровень соответствия
антибиотикопрофилактики клиническим протоколам и методическим рекомендациям в Национальном
научном центре онкологии и трансплантологии в 2015-2017 гг.
2. Определить роль клинических протоколов в
обеспечении правильной антибиотикопрофилактики
Цели исследования
Методы
• Ретроспективное когортное исследование (Январь, 2015 – Декабрь, 2017)
• Образец исследования – 180 медицинских карт:
→ Критерии включения: пациенты старше 18 лет, получающие
антибиотики до и после операции в период между 2015 и 2017 годами в Отделе Ортопедии
→ Критерии исключения: неполные медицинские записи
• Независимые переменные: вид, доза, время введения антибиотика
• Зависимая переменная: Уровень соответствия
антибиотикопрофилактики клиническим протоколам и рекомендациям ВОЗ
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• Более соблюдаемый критерий – «Дозировка предоперационного и послеоперационного введения антибиотиков»
• Менее соблюдаемый критерий – «Время предоперационного введения антибиотиков»
• Полное соблюдение антибиотикопрофилактики согласно клиническим протоколам и рекомендациям ВОЗ – 32,2%
• Рост полного соблюдения антибиотикопрофилактики в 2015-2017 годах – с 26,7% до 41,7%
Результаты исследования
Обсуждение
• Важность предоперационной антибиотикопрофилактики:
→ Улучшает состояние пациента (Vries et al., 2010)
→ Оказывает существенное влияние на снижение хирургических инфекций (Giusti et al., 2016)
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Обсуждение
85.0% 84.4%
42.2%
32.2%
15,00%
71.0%
98.0%
80.0%
53.0%
5,00%
Правильный выбор антибиотика
Правильная доза для предоперационного
Правильное время для предоперационного
Полное соответствие антибиотикопрофилактики
Отсутствие
антибиотикопрофилактики
Уровень соблюдения антибиотикопрофилактики согласно клиническим протоколам: Казахстан и Франция
Казахстан Франция
Рекомендации
• Проведение исследования во всех отделениях Национального научного центра онкологии и
трансплантологии, чтобы сравнить уровень соблюдения клинических протоколов.
• Проведение смешанного метода исследования, который будет включать качественные интервью анестезиологов, хирургов и медсестер и количественный анализ
медицинских записей пациентов.
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References
Bedouch, P., Labarère, J., Chirpaz, E., Allenet, B., Lepape, A., & Fourny, M. et al. (2004). Compliance With Guidelines on Antibiotic Prophylaxis in Total Hip Replacement Surgery: Results of a Retrospective Study of 416 Patients in a Teaching Hospital. Infection Control & Hospital Epidemiology, 25(04), 302-307.
http://dx.doi.org/10.1086/502396
Bratzler, D., Houck, P., Richards, C., & Steele, L. (2005). Use of Antimicrobial Prophylaxis for Major Surgery. Archives Of Surgery, 140(2), 174.
http://dx.doi.org/10.1001/archsurg.140.2.174
Committee opinion no. 464: Patient safety in the surgical environment. (2010, September). Retrieved April 01, 2018, from https://www.ncbi.nlm.nih.gov/pubmed/20733473
Giusti, A., Spila Alegiani, S., Ciofi degli Atti, M., Colaceci, S., Raschetti, R., & Arace, P. (2016). Surgical antibiotic prophylaxis in children: a mixed method study on healthcare professionals attitudes. BMC Pediatrics, 16(1). http://dx.doi.org/10.1186/s12887-016-0739-y
Jonge, S., Gans, S., Atema, J., Solomkin, J., Dellinger, P., & Boermeester, M. (2017). Timing of preoperative antibiotic prophylaxis in 54,552 patients and the risk of surgical site infection.Medicine,96(29), e6903. http://dx.doi.org/10.1097/md.0000000000006903
Page, C. (1993). Antimicrobial Prophylaxis for Surgical Wounds.Archives Of Surgery,128(1), 79. http://dx.doi.org/10.1001/archsurg.1993.01420130087014 RCHD(2016). Регламент по разработке/пересмотру клинических протоколов. РГП на ПХВ «Республиканский центр развития здравоохранения».
Retrieved April 01, 2018, from http://online.zakon.kz/Document/?doc_id=34359829 StataCorp. 2013. Stata Statistical Software: Release 13. College Station, TX: StataCorp LP.
Vries, E. N., Dijkstra, L., Smorenburg, S. M., Meijer, R. P., & Boermeester, M. A. (2010). Retrieved April 01, 2018, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2867812/
WHO (2017, March 29). WHO Launches Global Effort to Halve Medication-Related Errors in 5 Years. Retrieved April 01, 2018, from http://www.who.int/mediacentre/news/releases/2017/medication-related-errors/en/
WHO (2007). Best Practice Safety Protocols: Clinical procedures safety. Retrieved April 01, 2018, from http://www.who.int/surgery/publications/immesc_best_practice/en/
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