title: Missing data in quality of life research in Eastern Cooperative Oncology Group (ECOG) clinical trials: problems and solutions.
abstract: Incorporation of quality of life (QOL) investigation into Eastern Cooperative Oncology Group (ECOG) multi-centre clinical trials has led to innovative strategies for protocol design and high quality data collection. A scientific advisory committee reviews protocol design components, measurement selection, timing of assessments and compliance issues. Extensive educational programmes provide information about the scientific and clinical relevance of QOL protocols, as well as practical strategies for data collection and management. Compliance with QOL data collection standards is prospectively monitored and evaluated. Preliminary results from eight ECOG-run protocols found overall compliance to be approximately 85 per cent (94 per cent at baseline and 73 per cent during treatment). Selected patient and institutional factors were evaluated for their association with compliance.
authors.affiliation: Center on Outcomes, Research and Education, Evanston Northwestern Healthcare, IL 60201, USA. e-hahn@nwu.edu
authors.forename: E A
authors.initials: EA
authors.lastname: Hahn
authors.forename: K A
authors.initials: KA
authors.lastname: Webster
authors.forename: D
authors.initials: D
authors.lastname: Cella
authors.forename: D L
authors.initials: DL
authors.lastname: Fairclough
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000188:drug therapy; D002986:Clinical Trials as Topic / Q000379:methods*; D017322:Clinical Trials, Phase II as Topic / Q000379:methods; D017326:Clinical Trials, Phase III as Topic / Q000379:methods; D003625:Data Collection / Q000379:methods*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D015999:Multivariate Analysis; D009369:Neoplasms / Q000188:drug therapy / Q000523:psychology*; D010051:Ovarian Neoplasms / Q000188:drug therapy; D010349:Patient Compliance; D011788:Quality of Life; D012107:Research Design