title: Association between progression-free survival and health-related quality of life in oncology: a systematic review protocol.
abstract: There is an increasing number of new oncology drugs being studied, approved and put into clinical practice based on improvement in progression-free survival, when no overall survival benefits exist. In oncology, the association between progression-free survival and health-related quality of life is currently unknown, despite its importance for patients with cancer, and the unverified assumption that longer progression-free survival indicates improved health-related quality of life. Thus far, only 1 study has investigated this association, providing insufficient evidence and inconclusive results. The objective of this study protocol is to provide increased transparency in supporting a systematic summary of the evidence bearing on this association in oncology.
  
  
  
  Using the OVID platform in MEDLINE, Embase and Cochrane databases, we will conduct a systematic review of randomised controlled human trials addressing oncology issues published starting in 2000. A team of reviewers will, in pairs, independently screen and abstract data using standardised, pilot-tested forms. We will employ numerical integration to calculate mean incremental area under the curve between treatment groups in studies for health-related quality of life, along with total related error estimates, and a 95% CI around incremental area. To describe the progression-free survival to health-related quality of life association, we will construct a scatterplot for incremental health-related quality of life versus incremental progression-free survival. To estimate the association, we will use a weighted simple regression approach, comparing mean incremental health-related quality of life with either median incremental progression-free survival time or the progression-free survival HR, in the absence of overall survival benefit.
  
  
  
  Identifying direction and magnitude of association between progression-free survival and health-related quality of life is critically important in interpreting results of oncology trials. Systematic evidence produced from our study will contribute to improvement of patient care and practice of evidence-based medicine in oncology.
authors: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
authors: Bruno
authors: B
authors: Kovic
authors: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.
authors: Gordon
authors: G
authors: Guyatt
authors: Department of Oncology, Queen's University, Kingston, Ontario, Canada.
authors: Michael
authors: M
authors: Brundage
authors: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
authors: Lehana
authors: L
authors: Thabane
authors: Health Sciences Library, McMaster University, Hamilton, Ontario, Canada.
authors: Neera
authors: N
authors: Bhatnagar
authors: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada The Research Institute of St. Joseph's Healthcare, Hamilton, Ontario, Canada.
authors: Feng
authors: F
authors: Xie
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D018450:Disease Progression; D018572:Disease-Free Survival; D006304:Health Status; D006801:Humans; D009369:Neoplasms / Q000150:complications / Q000188:drug therapy*; D011788:Quality of Life; D012107:Research Design; D017741:Survivors; D000078202:Systematic Reviews as Topic
chemical_list: D000970:Antineoplastic Agents
keywords: CHEMOTHERAPY; ONCOLOGY