Exploring the Interplay between Rescue Drugs, Data Imputation, and Study Outcomes: Conceptual Review and Qualitative Analysis of an Acute Pain Data Set.

作者: Neil K. Singla , Diana S. Meske , Paul J. Desjardins

DOI: 10.1007/S40122-017-0074-5

关键词: Intensive care medicineAlternative medicineRegimenDesign choicePain medicineImputation (statistics)Clinical trialClinical study designMedical emergencyPopulationMedicine

摘要: In placebo-controlled acute surgical pain studies, provisions must be made for study subjects to receive adequate analgesic therapy. As such, most protocols allow a pre-specified regimen of open-label drugs (rescue drugs) as needed. The selection an appropriate rescue is critical experimental design choice. We hypothesized that too liberal could lead all arms receiving similar levels relief (thereby confounding results), while stringent high subject dropout rate (giving rise preponderance missing data). Despite the importance feature, there exist no published review articles or meta-analysis focusing on impact therapy outcomes. Therefore, when selecting regimen, researchers rely clinical factors (what analgesics do patients usually in scenarios) and/or anecdotal evidence. following article, we attempt bridge this gap by reviewing and discussing impacts common population: first metatarsal bunionectomy. function analysis (1) create framework discussion future exploration methodological (2) discuss interplay between data imputation techniques drugs, (3) inform readership regarding validity conclusions. Our findings indicate may degrade assay sensitivity, unacceptably rates.

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