title: Health-related quality of life assessment in randomised controlled trials in multiple myeloma: a critical review of methodology and impact on treatment recommendations.
abstract: OBJECTIVE
  Patients with multiple myeloma (MM) often have pronounced symptoms and substantially reduced quality of life. The aims of treatment are to control disease, maximise quality of life and prolong survival. Hence, health-related quality of life (HRQOL) should be an important end-point in randomised controlled trials (RCTs) in addition to traditional endpoints. We wanted to evaluate whether trials reporting HRQOL outcomes have influenced clinical decision making and whether HRQOL was assessed robustly according to predefined criteria.
  
  
  METHODS
  A systematic review identified RCTs in MM with HRQOL assessment as a study end-point. The methodological quality of these studies was assessed according to a checklist developed for evaluating HRQOL outcomes in clinical trials. The impact of the HRQOL results on clinical decision making was assessed, using published clinical guidelines as a reference.
  
  
  RESULTS
  Fifteen publications presenting RCTs with HRQOL as a study end-point were identified. In 13 trials, the author stated that HRQOL results should influence clinical decision making. We found, however, that the HRQOL data only had a limited impact on published treatment guidelines for bisphosphonates, high-dose treatment, interferon, erythropoiesis-stimulating agents and novel agents.
  
  
  CONCLUSIONS
  The present review indicates that the there are still few RCTs in MM including HRQOL as a study end-point. Systematic incorporation of HRQOL measures into clinical trials allows for a comparison of treatment arms that includes the patients' perspective. Before the full impact on clinical decisions can be realised, the quality and methodology of collecting HRQOL data must be further improved and the results rendered more comprehensible to clinicians.
authors: Department of Haematology, Oslo University Hospital, Ullevaal, Oslo, Norway. a.k.kvam@medisin.uio.no
authors: Ann Kristin
authors: AK
authors: Kvam
authors: Peter
authors: P
authors: Fayers
authors: Marianne
authors: M
authors: Hjermstad
authors: Nina
authors: N
authors: Gulbrandsen
authors: Finn
authors: F
authors: Wisloff
mesh_terms: D002985:Clinical Protocols; D006801:Humans; D009101:Multiple Myeloma / Q000175:diagnosis*; D017410:Practice Guidelines as Topic; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic / Q000379:methods