Efficacy Outcome Measures for Procedural Sedation Clinical Trials in Adults: An ACTTION Systematic Review

Mark R Williams; Andrew McKeown; Franklin Dexter; James R Miner; Daniel I Sessler; John Vargo; Dennis C Turk; Robert H Dworkin

doi:10.1213/ANE.0000000000000934

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Efficacy Outcome Measures for Procedural Sedation Clinical Trials in Adults: An ACTTION Systematic Review

Journal article

Peer reviewed

Efficacy Outcome Measures for Procedural Sedation Clinical Trials in Adults: An ACTTION Systematic Review

Mark R Williams, Andrew McKeown, Franklin Dexter, James R Miner, Daniel I Sessler, John Vargo, Dennis C Turk and Robert H Dworkin

Anesthesia and analgesia, Vol.122(1), pp.152-170

01/2016

DOI: 10.1213/ANE.0000000000000934

PMID: 26678470

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Abstract

Successful procedural sedation represents a spectrum of patient- and clinician-related goals. The absence of a gold-standard measure of the efficacy of procedural sedation has led to a variety of outcomes being used in clinical trials, with the consequent lack of consistency among measures, making comparisons among trials and meta-analyses challenging. We evaluated which existing measures have undergone psychometric analysis in a procedural sedation setting and whether the validity of any of these measures support their use across the range of procedures for which sedation is indicated. Numerous measures were found to have been used in clinical research on procedural sedation across a wide range of procedures. However, reliability and validity have been evaluated for only a limited number of sedation scales, observer-rated pain/discomfort scales, and satisfaction measures in only a few categories of procedures. Typically, studies only examined 1 or 2 aspects of scale validity. The results are likely unique to the specific clinical settings they were tested in. Certain scales, for example, those requiring motor stimulation, are unsuitable to evaluate sedation for procedures where movement is prohibited (e.g., magnetic resonance imaging scans). Further work is required to evaluate existing measures for procedures for which they were not developed. Depending on the outcomes of these efforts, it might ultimately be necessary to consider measures of sedation efficacy to be procedure specific.

Consciousness - drug effects

Endpoint Determination - standards

Predictive Value of Tests

Anesthesia - methods

Reproducibility of Results

Wakefulness - drug effects

Hypnotics and Sedatives - adverse effects

Humans

Hypnotics and Sedatives - administration & dosage

Quality Indicators, Health Care

Motor Activity - drug effects

Treatment Outcome

Anesthesia - adverse effects

Patient Satisfaction

Pain Threshold - drug effects

Research Design - standards

Surveys and Questionnaires

Clinical Trials as Topic - methods

Clinical Trials as Topic - standards

Pain Measurement

Anesthesia - standards

Details

Title: Subtitle: Efficacy Outcome Measures for Procedural Sedation Clinical Trials in Adults: An ACTTION Systematic Review
Creators: Mark R Williams - University of Rochester
Andrew McKeown
Franklin Dexter
James R Miner
Daniel I Sessler
John Vargo - Cleveland Clinic Lerner College of Medicine
Dennis C Turk
Robert H Dworkin
Resource Type: Journal article
Publication Details: Anesthesia and analgesia, Vol.122(1), pp.152-170
Publisher: United States
DOI: 10.1213/ANE.0000000000000934
PMID: 26678470
ISSN: 0003-2999
eISSN: 1526-7598
Grant note: U01 FD005936 / FDA HHS
Language: English
Date published: 01/2016
Academic Unit: Health Management and Policy; Anesthesia
Record Identifier: 9983806387202771

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22 Times Cited - Web of Science