Core Outcome Measures in Effectiveness Trials

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

General Information

Abstract:
Objective evaluations comparing different techniques and approaches to pediatric procedural sedation studies have been limited by a lack of consistency among the outcome measures used in assessment. This study reviewed those existing measures, which have undergone psychometric analysis in a pediatric procedural sedation setting, to determine to what extent and in what circumstances their use is justified across the spectrum of procedures, age groups, and techniques. The results of our study suggest that a wide range of measures has been used to assess the efficacy and effectiveness of pediatric procedural sedation. Most lack the evidence of validity and reliability that is necessary to facilitate rigorous clinical trial design, as well as the evaluation of new drugs and devices. A set of core pediatric sedation outcome domains and outcome measures can be developed on the basis of our findings. We believe that consensus among all stakeholders regarding appropriate domains and measures to evaluate pediatric procedural sedation is possible and that widespread implementation of such recommendations should be pursued.

Authors:
Williams, M. R. Nayshtut, M. Hoefnagel, A. McKeown, A. Carlson, D. W. Cravero, J. Lightdale, J. Mason, K. P. Wilson, S. Turk, D. C. Dworkin, R. H. Ward, D. S.

Publication

Journal:
Anesth Analg
Volume:
126
Issue:
3
Pages:
956 - 967
Year:
2018
DOI:
Further Study Information

Date:
Funding source(s):

Health Area

Disease Category
Anaesthesia & pain control

Disease Name
N/A

Target Population

Age Range
0 - 100

Sex
Either


Nature / type of Intervention
Procedure

Method(s)

Systematic review

Stakeholders Involved

Unknown

Study Type

Systematic review of outcome measures/measurement instruments

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