Analyzing the "correct" endpoint.
The choice of QOL endpoints for a study should be based on which score will most likely change if the treatment is favorable. How the QOL change is calculated should be based on the expected amount of missing data, how many time points data will be collected, and whether extreme outliers in the scores impact results. The study should have sufficient power to detect a meaningful difference between arms (typically 10 points on a 0-100 point scale) in the chosen QOL endpoint. At the conclusion of a study, several secondary endpoints can be analyzed which can provide additional information and confirm primary endpoint results.
Atherton
Pamela J
PJ
Department of Health Science Research, Mayo Clinic, Rochester, Minnesota, USA.
Novotny
Paul J
PJ
Tan
Angelina D
AD
D000818:Animals; D002356:Cartilage / Q000737:chemistry; D023381:Endpoint Determination / Q000379:methods*; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000627:therapeutic use; D006801:Humans; D009369:Neoplasms / Q000628:therapy*; D017063:Outcome Assessment, Health Care / Q000592:standards*; D011788:Quality of Life; D011878:Radiotherapy / Q000523:psychology; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D011994:Recombinant Proteins; D012647:Self-Assessment; D012754:Sharks
D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa