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WORKSHEET for PROPOSED Evidence-Based GUIDELINE RECOMMENDATIONS
NOTE: Save worksheet using the following filename format: Taskforce.Topic.Author.Date.Doc where Taskforce is a=ACLS, b=BLS, p=Pediatric, n=neonatal and i=Interdisciplinary. Use 2 or 3 letter abbreviation for author’s name and 30Jul03 as sample date format.
STEP 1: STATE THE PROPOSAL. State if this is a proposed new guideline; revision to current guideline; or deletion of current guideline.
Existing guideline, practice or training activity, or new guideline:
The ACC/AHA Guidelines 2000 for the management of UA/NSTEMI recommended that “anticoagulation with subcutaneous low-molecular-weight heparin or intravenous unfractionated heparin should be added to antiplatelet therapy with aspirin, clopidogrel, or both.” (Class 1, Level B) This recommendation was upgraded in 2002 to Class 1, Level A, and was reiterated for management of these patients in the emergency department (Pollack, 2003 Ann Emerg Med). Also in these guidelines was the recommendation that “Enoxaparin is preferable to unfractionated heparin as an anticoagulant in patients with unstable angina/NSTEMI, unless coronary artery bypass grafting is planned within 24 hours” (Class IIa, Level A).
The 2004 ACC/AHA Guidelines for management of patients with STEMI include the following recommendations regarding adjunctive therapy with anticoagulants:
“Low-molecular-weight heparin might be considered an acceptable alternative to UFH as ancillary therapy for patients aged less than 75 years who are receiving fibrinolytic therapy, provided that significant renal dysfunction (serum creatinine greater than 2.5 mg/dL in men or 2.0 mg/dL in women) is not present.”
“Enoxaparin (30-mg IV bolus followed by 1.0 mg/kg SC every 12 hours until hospital discharge) used in combination with full-dose tenecteplase is the most comprehensively studied regimen in patients aged less than 75 years of age. (Level of Evidence: B)
Low-molecular-weight heparin should not be used as an alternative to UFH as ancillary therapy in patients aged more than 75 years who are receiving fibrinolytic therapy. (Level of Evidence: B)
Low-molecular-weight heparin should not be used as an alternative to UFH as ancillary therapy in patients less than 75 years who are receiving fibrinolytic therapy but have significant renal dysfunction (serum creatinine greater than 2.5 mg/dL in men or 2.0 mg/dL in women). (Level of Evidence: B)
Step 1A: Refine the question; state the question as a positive (or negative) hypothesis. State proposed guideline recommendation as a specific, positive hypothesis. Use single sentence if possible. Include type of patients; setting (in- /out-of-hospital); specific interventions (dose, route); specific outcomes (ROSC vs. hospital discharge).
The safety, efficacy and feasibility of low molecular weight heparin (LMWH) is the same as or better than unfractionated heparin (UFH), in prehospital and emergency department management of acute coronary syndromes (ACS) and acute myocardial infarction (AMI).
Step 1B: Gather the Evidence; define your search strategy. Describe search results; describe best sources for evidence.
1) Searched databases as follows:
EMBASE (1980 to 2004 Week 25): best source
1 *Heparin/ct, cb, cm, iv, pa, pr, pe, pd, sc [Clinical Trial, Drug Combination, Drug Comparison, Intravenous Drug Administration, Parenteral Drug Administration, Pharmaceutics, Pharmacoeconomics, Pharmacology, Subcutaneous Drug Administration] (6676)
2 exp Low Molecular Weight Heparin/ct, ad, cb, cm, iv, dv, do, pa, dt, pr, pe, pd, sc [Clinical Trial, Drug Administration, Drug Combination, Drug Comparison, Intravenous Drug Administration, Drug Development, Drug Dose, Parenteral Drug Administration, Drug Therapy, Pharmaceutics, Pharmacoeconomics, Pharmacology, Subcutaneous Drug Administration] (9364)
3 heart muscle ischemia/ or silent myocardial ischemia/ or heart infarction/ or heart ventricle infarction/ (80460)
4 exp Ischemic Heart Disease/co, di, dm, si, dt, th [Complication, Diagnosis, Disease Management, Side Effect, Drug Therapy, Therapy] (61310)
5 exp first aid/ or exp emergency health service/ or exp resuscitation/ or exp heart infarction/ or exp patient transport/ or exp article/ or exp major clinical study/ or exp human/ or prehospital.mp. or exp heart arrest/ (6635836)
6 exp AGENTS USED IN EMERGENCY MEDICINE/ or exp EMERGENCY TREATMENT/ or exp EMERGENCY HEALTH SERVICE/ or exp EMERGENCY/ or exp EMERGENCY MEDICINE/ or exp EMERGENCY WARD/ (210827)
7 1 and 2 (1712)
8 3 or 4 (111625)
9 5 or 6 (6684838)
10 7 and 8 and 9 (234)
11 limit 10 to human (227)
MEDLINE (1966 – June week 3 2004):
1 heparin/ and exp heparin, low-molecular-weight/ (1555)
2 myocardial ischemia/ or coronary disease/ or exp angina pectoris/ or exp myocardial infarction/ (212837)
3 1 and 2 (170)
4 limit 3 to human (169)
Note: If also tried to combine with Emergency Medicine or Prehospital terms, no articles were found
Cochrane database (CDSR, ACP Journal Club, DARE, CCTR)
1 heparin/ and exp heparin, low-molecular-weight/ (290)
2 myocardial ischemia/ or coronary disease/ or exp angina pectoris/ or exp myocardial infarction/ (10371)
3 1 and 2 (50)
AHA Endnote 7 Master Library
1 searched all fields that contain acute coronary syndrome or myocardial infarction or myocardial ischemia or angina (1453)
2 searched within 1 all fields that contain heparin or low molecular weight heparin or enoxaparin or fraxaparin or dalteparin (150)
3 searched within 2, all fields that contain emergency or prehospital (17)
2) Combined the end results of the above database searches in my own Endnote library where I deleted duplicates.
3) Reviewed titles electronically and deleted those clearly unrelated to question
4) Identified 236 articles. Reviewed abstracts electronically excluded 126 using criteria below.
5) Of 110 articles obtained, 50 were suitable for critical appraisal and inclusion in worksheet.
6) 4 additional articles obtained after initial worksheet completion, 3 were suitable for inclusion in worksheet. Total 53.
List electronic databases searched (at least AHA EndNote 7 Master library [http://ecc.heart.org/], Cochrane database for systematic reviews and Central Register of Controlled Trials [http://www.cochrane.org/], MEDLINE [http://www.ncbi.nlm.nih.gov/PubMed/ ], and Embase), and hand searches of journals, review articles, and books.
Embase 1980 to 2004 Week 25
Medline 1966 to June Week 3 2004
Cochrane database (reviews and trials)
AHA Endnote 7 Master Library
Reference lists of articles hand searched to obtain other relevant clinical trials.
• State major criteria you used to limit your search; state inclusion or exclusion criteria (e.g., only human studies with control group? no animal studies? N subjects > minimal number? type of methodology? peer-reviewed manuscripts only? no abstract-only studies?)
The searches were limited to human studies, peer and non-peer reviewed manuscripts cited in the world’s literature.
Articles excluded were abstract only studies, all narrative reviews and published systematic reviews without a meta-analysis and those that had no relevance to emergency department or prehospital settings (Specifically, in-hospital studies more than 72 hours after patient presentation, post percutaneous angiography trials, trials investigating changes in coagulation factors without clinical end points and long-term outpatient care).
• Number of articles/sources meeting criteria for further review: Create a citation marker for each study (use the author initials and date or Arabic numeral, e.g., “Cummins-1”). . If possible, please supply file of best references; EndNote 6+ required as reference manager using the ECC reference library.
Searches narrowed after title/ abstract review to 53 articles
STEP 2: ASSESS THE QUALITY OF EACH STUDY
Step 2A: Determine the Level of Evidence. For each article/source from step 1, assign a level of evidence—based on study design and methodology.
|Note: Save worksheet using the following filename format: Taskforce. Topic. Author. Date. Doc where Taskforce is a=acls, b=bls, p=Pediatric, n=neonatal and i=Interdisciplinary. Use 2 or 3 letter abbreviation for author’s name and 30Jul03 as sample date format||Remember to save the blank worksheet template using the filename format|
|C research Guide 2 iting your references using the Harvard (Author-Date) system||Author’s note: This bibliography includes sources for all references in the published text and materials that the author has seen and considers useful for the|
|C. J. Date is an independent author, lecturer, researcher, and consultant of international renown, specializing in relational database technology. He is best||Rich Text Version (rtf) – this version of the report has been produced in rtf format and all maps, tables and charts have been removed. A full version is available on this website in pdf format|
|Rich Text Version (rtf) – this version of the report has been produced in rtf format and all maps, tables and charts have been removed. A full version is available on this website in pdf format||Country/ страна : Veterinary certificate to eu /Ветеринарный сертификат в ес|
Вид Identification system/ Date of application of Identification number/ Date of birth
|Title Name and affiliation of each author, and e-mail address of the corresponding author are required. Abstract||Nr пациента /patient no|
При беременности: предполагаемая дата родов/in case of pregnancy please note calculated date of birth