COSMIN database

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

Williams, M. R., McKeown, A., Dexter, F., Miner, J. R., Sessler, D. I., Vargo, J., Turk, D. C., and Dworkin, R. H.
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.
Anesth Analg
1526-7598 (Electronic); 0003-2999 (Linking)
Publication year:
Symptom status:
Cognitive/mental state
Physical state
Adults (18-65)
Factors influencing health status and contact with health services
PRO / non-PRO:
Non-patient Reported Outcome
Patient Reported Outcome
Type of measurement instrument:
1 - Questionnaires
6 - Clinical rating scales
7 - Observations
American Society of Anesthesiologists (ASA) continuum of depth of sedation
CBNPS - Colorado Behavioral Numerical Pain Scale
CSSI - Clinician Satisfaction with Sedation Instrument
Gentili Scale
Gillham Scale
Hong Scale
ISAS - Iowa Satisfaction with Anesthesia Scale
L-WISC - La Crosse Wisconsin Intra-Endoscopy Sedation Comfort scale
MWSS - Modified Wilson Sedation Scale
NAPCOMS - Nurse Assessed Patient Comfort Score
OAA/S - Observer’s Assessment of Alertness/Sedation
PSSI - Patient Satisfaction with Sedation Instrument
RSS - Ramsay Sedation Scale
VAS - Visual Analogue Scale   
WSS - Wilson Sedation Scale