Antimicrobial Stewardship in Pediatric Surgery (AbxPS)
2018년 3월 16일 업데이트: Dr Anna Shawyer, Alberta Children's Hospital
An Antimicrobial Stewardship Intervention Program in Pediatric Surgery
Acute appendicitis is a common surgical emergency in children. Non-perforated appendicitis patients do not require antibiotics after appendectomy. Although guidelines and recommendations exist to decrease post-operative antibiotic mis-use after appendectomy, surgeons continue to prescribe unwarranted antibiotics.
The aim of this study is to determine if an Antimicrobial Stewardship Program in Pediatric Surgery will decrease the use of un-warranted antibiotics.
연구 개요
상세 설명
Many surgeons continue to treat non-perforated or "borderline perforated" appendicitis with postoperative antibiotics despite an evidence-based definition of perforation (in the pediatric surgical literature) and many guidelines and recommendations that specify that no postoperative antibiotics are required. Children with perforated appendicitis are also often treated with longer-than-necessary courses of antibiotics. Although surgeons may feel that they only prescribe additional doses on occasion, evidence suggests that this behavior occurs in over 50% of children with non-perforated appendicitis.
These additional doses contribute to a longer length of stay, excess costs to the health care system, and disrupt patient flow. Additionally, the patients are exposed to more antibiotics and their potential for adverse effects (such as incorrect dose, incorrect medication, allergic reaction, antimicrobial resistance or c difficile infection).
Antimicrobial stewardship programs have been successful in pediatrics and adult general surgery in curbing unwarranted antibiotic use, but have never been evaluated in pediatric general surgery.
연구 유형
관찰
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이하 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
샘플링 방법
확률 샘플
연구 인구
The study population is the pediatric surgeons at our institution who will have their antibiotic prescribing audited.
설명
Inclusion Criteria:
- Participant (surgeon) is a pediatric surgeon at McMaster Children's Hospital and takes care of patients under the age of 18 who undergo appendectomy.
- Participant (surgeon) is able to read, write and understand English.
- Participant (surgeon) is able to provide informed consent.
Exclusion Criteria:
- Participant (surgeon) only has patients who undergo drain insertion, PICC line insertion or a secondary operation during the same admission
- Participant (surgeon) only has patients who do not undergo operation (i.e. "conservative management with interval appendectomy)
- Participant (surgeon) does not provide informed consent
- Participant (surgeon) does not understand written and spoken English diagnosis other than appendicitis at time of operation
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
NO Antimicrobial Stewardship Program
Prospective cohort of children who undergo appendectomy for acute appendicitis (perforated and non-perforated) BEFORE the implementation of the Antimicrobial Stewardship Program.
|
|
|
WITH Antimicrobial Stewardship Program
Prospective cohort of children who undergo appendectomy for acute appendicitis (perforated and non-perforated) WITH the implementation of the Antimicrobial Stewardship Program.
|
Twice weekly meeting with Infectious Disease and Pediatric Surgery team members to audit antibiotics prescribed and suggest role for discontinuation.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Compliance with American Pediatric Surgical Association recommendations for postoperative antibiotics for appendicitis
기간: From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
Includes both intravenous and oral antibiotics prescribed, both during the time frame from admission until discharge, in addition to any prescription given for home, oral antibiotics.
Measured as yes/no
|
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Postoperative intravenous antibiotics for non-perforated appendicitis
기간: From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
measured as number of days (ie number of doses divided by number of doses-per-day)
|
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
|
Postoperative oral antibiotics for non-perforated appendicitis
기간: From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
measured as number of days (ie number of doses divided by number of doses-per-day)
|
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Postoperative fever
기간: Length of admission
|
Rectal temperature above 100.4ºF
(38ºC), measured as yes/no and on what postoperative day Oral temperature above 100ºF (37.8ºC)
Axillary (armpit) temperature above 99ºF (37.2ºC)
Ear (tympanic membrane) temperature above 100.4ºF
(38ºC) in rectal mode or 99.5ºF (37.5ºC) in oral mode Forehead (temporal artery) temperature above 100.4ºF
(38ºC)
|
Length of admission
|
|
Readmission within 30 days
기간: Within 30 days of discharge
|
Need for readmission within 30 days of discharge, measured as yes/no
|
Within 30 days of discharge
|
|
Peripherally inserted intravenous catheter (PICC)
기간: From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
Need for PICC insertion for long term antibiotics, intravenous fluids or parenteral nutrition, measured as yes/no
|
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
|
Drain insertion
기간: From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
Need for a drain insertion (by interventional radiology) for postoperative abscess, measured as yes/no
|
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
|
Re-operation
기간: From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
Need for re-operation on the same admission, measured as yes/no
|
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
|
Length of Stay
기간: Length of admission
|
Measured in days (from date of admission until date of discharge)
|
Length of admission
|
|
Adverse reaction to antibiotic
기간: From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
Measured as yes/no in addition to description of reaction (eg hives, shortness of breath)
|
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
|
Wrong medication/Wrong dose
기간: From date of admission until date of first follow-up visit, typically within 4-6 weeks of discharge
|
Measured as yes/no in addition to description of problem (wrong dose, wrong medication)
|
From date of admission until date of first follow-up visit, typically within 4-6 weeks of discharge
|
|
C difficile infection
기간: From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
Measured as yes/no based on stool assay
|
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Anna Shawyer, MS, MSc, Alberta Children's Hospital
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- St Peter SD, Sharp SW, Holcomb GW 3rd, Ostlie DJ. An evidence-based definition for perforated appendicitis derived from a prospective randomized trial. J Pediatr Surg. 2008 Dec;43(12):2242-5. doi: 10.1016/j.jpedsurg.2008.08.051.
- Lee SL, Islam S, Cassidy LD, Abdullah F, Arca MJ; 2010 American Pediatric Surgical Association Outcomes and Clinical Trials Committee. Antibiotics and appendicitis in the pediatric population: an American Pediatric Surgical Association Outcomes and Clinical Trials Committee systematic review. J Pediatr Surg. 2010 Nov;45(11):2181-5. doi: 10.1016/j.jpedsurg.2010.06.038.
- Srigley JA, Brooks A, Sung M, Yamamura D, Haider S, Mertz D. Inappropriate use of antibiotics and Clostridium difficile infection. Am J Infect Control. 2013 Nov;41(11):1116-8. doi: 10.1016/j.ajic.2013.04.017. Epub 2013 Aug 7.
- Rangel SJ, Fung M, Graham DA, Ma L, Nelson CP, Sandora TJ. Recent trends in the use of antibiotic prophylaxis in pediatric surgery. J Pediatr Surg. 2011 Feb;46(2):366-71. doi: 10.1016/j.jpedsurg.2010.11.016.
- Ghaleb MA, Barber N, Franklin BD, Wong IC. The incidence and nature of prescribing and medication administration errors in paediatric inpatients. Arch Dis Child. 2010 Feb;95(2):113-8. doi: 10.1136/adc.2009.158485. Epub 2010 Feb 4.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2015년 1월 1일
기본 완료 (예상)
2015년 12월 1일
연구 완료 (예상)
2015년 12월 1일
연구 등록 날짜
최초 제출
2014년 10월 8일
QC 기준을 충족하는 최초 제출
2014년 10월 21일
처음 게시됨 (추정)
2014년 10월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 3월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 3월 16일
마지막으로 확인됨
2018년 3월 1일
추가 정보
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