Evaluating Patient-Centered Outcomes in Clinical Trials of Procedural Sedation, Part 1 Efficacy
| Autor: | Bob A. Rappaport, John W. Berkenbosch, Raymond A. Dionne, David Gozal, Rebecca S. Twersky, Joseph P. Cravero, Mark R. Williams, Randall M. Clark, David Grayzel, Dennis C. Turk, Daniel I. Sessler, Michael R. Irwin, Pratik P. Pandharipande, Franklin Dexter, Keira P. Mason, Jerrold Lerman, Richard R. Riker, Robert H. Dworkin, John J. Vargo, Robert E. O'Connor, Denham S. Ward, Isabelle Constant, Douglas W. Carlson, Jenifer R. Lightdale, Joseph R. Tobin, James R. Miner |
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| Rok vydání: | 2017 |
| Předmět: |
medicine.medical_specialty
Biomedical Research Endpoint Determination Sedation media_common.quotation_subject Analgesic Conscious Sedation Food and drug administration 03 medical and health sciences 0302 clinical medicine 030202 anesthesiology Patient-Centered Care Humans Hypnotics and Sedatives Medicine Anesthesia 030212 general & internal medicine Intensive care medicine media_common Clinical Trials as Topic business.industry Addiction Patient-centered outcomes Congresses as Topic Clinical trial Treatment Outcome Anesthesiology and Pain Medicine Patient Satisfaction District of Columbia Anesthetic Patient Safety medicine.symptom business medicine.drug |
| Zdroj: | Anesthesia & Analgesia. 124:821-830 |
| ISSN: | 0003-2999 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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