HEALTH-RELATED QUALITY OF LIFE (HRQOL) IN CERVICAL CANCER- CLINICAL SIGNIFICANCE AND METHODOLOGICAL ISSUES
Author(s)
Siddiqui MK, Gupta J, Sehgal MHeron Health Private Ltd, Chandigarh, Chandigarh, India
Presentation Documents
OBJECTIVES: To assess the clinical use of HRQoL instruments in RCTs in cervical carcinoma and evaluate pertinent methodological issues. METHODS: RCTs investigating HRQoL benefit of therapies in cervical carcinoma in adult females, published in English language were included. Cochrane Central Register of Controlled Trials, MEDLINE and EMBASE were searched from inception to 2010. Two reviewers independently assessed the trials for inclusion and performed extraction. RESULTS: Of the 96 RCTs identified, 13 RCTs met the inclusion criteria. Ten trials compared different chemotherapy regimens in first to third line treatment. The most commonly used QoL instrument was Functional Assessment of Cancer Therapy (FACT-G) (46% trials). Alternatively cancer specific European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire-Core 30 (EORTC QLQ-30), SF-36, and Linear Analogue Scale Assessment (LASA 100 mm) were used either alone or in conjunction with the Brief pain Inventory (BPI). Only one trial reported HRQoL as a primary objective. HRQoL results were presented adequately in 61% trials which were analysable. Statistically significant differences in HRQoL between treatment groups were studied in 69% studies, but the clinically meaningful difference was examined in only one study. Prognostic value of QoL was assessed in only two trials (15%). Most widely observed methodological issues included, lack of priori hypothesis (92% studies) and lack of methods to deal with missing data (85%). Other issues included lack of details on domain, variability in time points of administration of a tool and patient’s non-compliance, reported in ~60% studies. CONCLUSIONS: HRQoL is included as an outcome in the studies investigating therapies in cervical carcinoma but clinically meaningful interpretations of HRQoL results are rarely considered. The methodological shortcomings in the assessment and analysis of HRQoL outcomes should be examined further to derive clinically meaningful and correlating evidence.
Conference/Value in Health Info
2010-11, ISPOR Europe 2010, Prague, Czech Republic
Value in Health, Vol. 13, No. 7 (November 2010)
Code
PCN131
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Oncology