Measuring quality of life in mental health: Are we asking the right questions?

Measuring quality-adjusted-life years using generic preference-based quality of life measures is common practice when evaluating health interventions. However, there are concerns that measures in common use, such as the EQ-5D and SF-6D, focus overly on physical health and therefore may not be appropriate for measuring quality of life for people with mental health problems. The aim of this research was to identify the domains of quality of life that are important to people with mental health problems in order to assess the content validity of these generic measures. Qualitative semi-structured interviews were conducted with 19 people, recruited from UK mental health services, with a broad range of mental health problems at varying levels of severity. This complemented a previous systematic review and thematic synthesis of qualitative studies on the same topic. Seven domains important to quality of life for people with mental health problems were identified: well-being and ill-being; relationships and a sense of belonging; activity; self-perception; autonomy, hope and hopelessness; and physical health. These were consistent with the systematic review, with the addition of physical health as a domain, and revealed a differing emphasis on the positive and negative aspects of quality of life according to the severity of the mental health problems. We conclude that the content of existing generic preference-based measures of health do not cover this domain space well. Additionally, because people may experience substantial improvements in their quality of life without registering on the positive end of a quality of life scale, it is important that the full spectrum of negative through to positive aspects of each domain are included in any quality of life measure

Corticosteroid use endpoints in neuro-oncology: Response Assessment in Neuro-Oncology Working Group

Background:Corticosteroids are the mainstay of treatment for peritumor edema but are often associated with significant side effects. Therapies that can reduce corticosteroid use would potentially be of significant benefit to patients. However, currently there are no standardized endpoints evaluating corticosteroid use in neuro-oncology clinical trials. Methods:The Response Assessment in Neuro-Oncology (RANO) Working Group has developed consensus recommendations for endpoints evaluating corticosteroid use in clinical trials in both adults and children with brain tumors. Results:Responders are defined as patients with a 50% reduction in total daily corticosteroid dose compared with baseline or reduction of the total daily dose to ≤2 mg of dexamethasone (or equivalent dose of other corticosteroid); baseline dose must be at least 4 mg of dexamethasone daily (or equivalent dose of other corticosteroids) for at least one week. Patients must have stable or improved Neurologic Assessment in Neuro-Oncology (NANO) score or Karnofsky performance status score or Eastern Cooperative Oncology Group (ECOG) (Lansky score for children age <16 y), and an improved score on a relevant clinical outcome assessment tool. These criteria must be sustained for at least 4 weeks after baseline assessment to be considered a response, and are confirmed 4 weeks after that (ie, 8 wk after baseline assessment) to be considered a sustained response. Conclusions:This RANO proposal for corticosteroid use endpoints in neuro-oncology clinical trials may need to be refined and will require prospective validation in clinical studies