Core Outcome Measures in Effectiveness Trials

Evaluating Patient-Centered Outcomes in Clinical Trials of Procedural Sedation, Part 1 Efficacy: Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations

General Information

Abstract:
The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research, established by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks public-private partnership with the US Food and Drug Administration, convened a meeting of sedation experts from a variety of clinical specialties and research backgrounds with the objective of developing recommendations for procedural sedation research. Four core outcome domains were recommended for consideration in sedation clinical trials: (1) safety, (2) efficacy, (3) patient-centered and/or family-centered outcomes, and (4) efficiency. This meeting identified core outcome measures within the efficacy and patient-centered and/or family-centered domains. Safety will be addressed in a subsequent meeting, and efficiency will not be addressed at this time. These measures encompass depth and levels of sedation, proceduralist and patient satisfaction, patient recall, and degree of pain experienced. Consistent use of the recommended outcome measures will facilitate the comprehensive reporting across sedation trials, along with meaningful comparisons among studies and interventions in systematic reviews and meta-analyses.

Authors:
Williams, M. R. Ward, D. S. Carlson, D. Cravero, J. Dexter, F. Lightdale, J. R. Mason, K. P. Miner, J. Vargo, J. J. Berkenbosch, J. W. Clark, R. M. Constant, I. Dionne, R. Dworkin, R. H. Gozal, D. Grayzel, D. Irwin, M. G. Lerman, J. O'Connor, R. E. Pandharipande, P. Rappaport, B. A. Riker, R. R. Tobin, J. R. Turk, D. C. Twersky, R. S. Sessler, D. I.

Publication

Journal:
Anesth Analg
Volume:
124
Issue:
3
Pages:
821 - 830
Year:
2017
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)

Literature review
Semi structured discussion

Semistructured meeting with formal presentations by selected participants that stimulated discussion sessins. Before the meeting, all participants were sent copies of the set of publications9–18 that presented important aspects of procedural sedation research and the results of recent phase 3 clinical trials to illustrate the diversity of outcomes that were used. A recent systematic review article was not available at the time of the meeting;19 however, the literature review on which this article was based was presented.


Stakeholders Involved

Clinical experts
Governmental agencies
Pharmaceutical industry representatives
Researchers

Study Type

COS for clinical trials or clinical research

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