Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
This page is part of the Evidence Based Medicine on FHIR Implementation Guide (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
| Active as of 2023-12-17 |
Resource Citation "179637" Version "1" Updated "2023-11-27 14:51:05+0000"
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url: https://fevir.net/resources/Citation/179637
identifier: FEvIR Object Identifier: 179637, id: 18508207
version: 1.0.0-ballot
title: 18508207 A Phase 3 placebo-controlled, double-blind, multi-site trial of the alpha-2-adrenergic agonist, lofexidine, for opioid withdrawal.
status: active
date: 2023-12-17 16:55:23+0000
publisher: HL7 International / Clinical Decision Support
contact: HL7 International / Clinical Decision Support: http://www.hl7.org/Special/committees/dss
description: This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.
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identifier: id: 18508207, mid: NIHMS61453, id: PMC2613766, id: 10.1016/j.drugalcdep.2008.04.002, pii: S0376-8716(08)00140-3
Titles
Type Language Text Primary title (Title Type#primary) English (Tags for the Identification of Languages#en) A Phase 3 placebo-controlled, double-blind, multi-site trial of the alpha-2-adrenergic agonist, lofexidine, for opioid withdrawal. Abstracts
Text **CONTEXT:** Lofexidine is an alpha-2-adrenergic receptor agonist that is approved in the United Kingdom for the treatment of opioid withdrawal symptoms. Lofexidine has been reported to have more significant effects on decreasing opioid withdrawal symptoms with less hypotension than clonidine. **OBJECTIVE:** To demonstrate that lofexidine is well tolerated and effective in the alleviation of observationally defined opioid withdrawal symptoms in opioid dependent individuals undergoing medically supervised opioid detoxification as compared to placebo. **DESIGN:** An inpatient, Phase 3, placebo-controlled, double-blind, randomized multi-site trial with three phases: (1) opioid agonist stabilization phase (days 1-3), (2) detoxification/medication or placebo phase (days 4-8), and (3) post detoxification/medication phase (days 9-11). **SUBJECTS:** Sixty-eight opioid dependent subjects were enrolled at three sites with 35 randomized to lofexidine and 33 to placebo. **MAIN OUTCOME MEASURE:** Modified Himmelsbach Opiate Withdrawal Scale (MHOWS) on study day 5 (second opioid detoxification treatment day). **RESULTS:** Due to significant findings, the study was terminated early. On the study day 5 MHOWS, subjects treated with lofexidine had significantly lower scores (equating to fewer/less severe withdrawal symptoms) than placebo subjects (least squares means 19.5+/-2.1 versus 30.9+/-2.7; p=0.0019). Lofexidine subjects had significantly better retention in treatment than placebo subjects (38.2% versus 15.2%; Log rank test p=0.01). **CONCLUSIONS:** Lofexidine is well tolerated and more efficacious than placebo for reducing opioid withdrawal symptoms in inpatients undergoing medically supervised opioid detoxification. relatesTo
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forenameInitials: J
entry
name: Frances McSherry
forenameInitials: F
entry
name: Kathy Boardman
forenameInitials: K
entry
name: David K Davies
forenameInitials: DK
entry
name: Charles P O'Brien
forenameInitials: CP
entry
name: Walter Ling
forenameInitials: W
entry
name: Herbert Kleber
forenameInitials: H
entry
name: Barbara H Herman
forenameInitials: BH
Generated Narrative: Practitioner #author0
name: Elmer Yu
Generated Narrative: Practitioner #author1
name: Karen Miotto
Generated Narrative: Practitioner #author2
name: Evaristo Akerele
Generated Narrative: Practitioner #author3
name: Ann Montgomery
Generated Narrative: Practitioner #author4
name: Ahmed Elkashef
Generated Narrative: Practitioner #author5
name: Robert Walsh
Generated Narrative: Practitioner #author6
name: Ivan Montoya
Generated Narrative: Practitioner #author7
name: Marian W Fischman
Generated Narrative: Practitioner #author8
name: Joseph Collins
Generated Narrative: Practitioner #author9
name: Frances McSherry
Generated Narrative: Practitioner #author10
name: Kathy Boardman
Generated Narrative: Practitioner #author11
name: David K Davies
Generated Narrative: Practitioner #author12
name: Charles P O'Brien
Generated Narrative: Practitioner #author13
name: Walter Ling
Generated Narrative: Practitioner #author14
name: Herbert Kleber
Generated Narrative: Practitioner #author15
name: Barbara H Herman
Generated Narrative: ArtifactAssessment #meshHeading0
artifact: #
content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Adrenergic alpha-Agonists (#D000316)
freeToShare: true
component
type: qualifier ()
classifier: is not a major topic ()
component
type: qualifier ()
classifier: adverse effects (#Q000009)
component
component
type: qualifier ()
classifier: therapeutic use (#Q000627)
component
content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Adult (#D000328)
freeToShare: true
Components
Type Classifier qualifier () is not a major topic () content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Analgesics, Opioid (#D000701)
freeToShare: true
Components
Type Classifier qualifier () is Major topic () content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Clonidine (#D003000)
freeToShare: true
component
type: qualifier ()
classifier: is not a major topic ()
component
type: qualifier ()
classifier: adverse effects (#Q000009)
component
component
type: qualifier ()
classifier: analogs & derivatives (#Q000031)
component
component
type: qualifier ()
classifier: therapeutic use (#Q000627)
component
content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Data Collection (#D003625)
freeToShare: true
Components
Type Classifier qualifier () is not a major topic () content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Double-Blind Method (#D004311)
freeToShare: true
Components
Type Classifier qualifier () is not a major topic () content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Female (#D005260)
freeToShare: true
Components
Type Classifier qualifier () is not a major topic () content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Humans (#D006801)
freeToShare: true
Components
Type Classifier qualifier () is not a major topic () content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Male (#D008297)
freeToShare: true
Components
Type Classifier qualifier () is not a major topic () content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Middle Aged (#D008875)
freeToShare: true
Components
Type Classifier qualifier () is not a major topic () content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Psychiatric Status Rating Scales (#D011569)
freeToShare: true
Components
Type Classifier qualifier () is not a major topic () content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Substance Abuse Detection (#D015813)
freeToShare: true
Components
Type Classifier qualifier () is not a major topic () content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Substance Withdrawal Syndrome (#D013375)
freeToShare: true
component
type: qualifier ()
classifier: is not a major topic ()
component
type: qualifier ()
classifier: drug therapy (#Q000188)
component
content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Survival Analysis (#D016019)
freeToShare: true
Components
Type Classifier qualifier () is not a major topic () content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Treatment Outcome (#D016896)
freeToShare: true
Components
Type Classifier qualifier () is not a major topic ()
IG © 2022+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-17
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