Minimally Important Differences for Interpreting EORTC QLQ-C30 Scores in Patients With Advanced Breast Cancer.

BACKGROUND: We aimed to estimate the minimally important difference (MID) for interpreting group-level change over time, both within a group and between groups, for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30 (EORTC QLQ-C30) scores in patients with advanced breast cancer. METHODS: Data were derived from two published EORTC trials. Clinical anchors (eg, performance status [PS]) were selected using correlation strength and clinical plausibility of their association with a particular QLQ-C30 scale. Three change status groups were formed: deteriorated by one anchor category, improved by one anchor category, and no change. Patients with greater anchor changes were excluded. The mean change method was used to estimate MIDs for within-group change, and linear regression was used to estimate MIDs for between-group differences in change over time. For a given QLQ-C30 scale, MID estimates from multiple anchors were triangulated to a single value via a correlation-based weighted average. RESULTS: MIDs varied by QLQ-C30 scale, direction (improvement vs deterioration), and anchor. MIDs for within-group change ranged from 5 to 14 points (improvement) and -14 to -4 points (deterioration), and MIDs for between-group change over time ranged from 4 to 11 points and from -18 to -4 points. Correlation-weighted MIDs for most QLQ-C30 scales ranged from 4 to 10 points in absolute values. CONCLUSIONS: Our findings aid interpretation of changes in EORTC QLQ-C30 scores over time, both within and between groups, and for performing more accurate sample size calculations for clinical trials in advanced breast cancer.

Interpreting European Organisation for Research and Treatment for Cancer Quality of life Questionnaire core 30 scores as minimally importantly different for patients with malignant melanoma.

INTRODUCTION: Health-related quality of life (HRQOL) is increasingly recognised as an important end-point in cancer clinical trials. The concept of minimally important difference (MID) enables interpreting differences and changes in HRQOL scores in terms of clinical meaningfulness. We aimed to estimate MIDs for interpreting group-level change of European Organisation for Research and Treatment for Cancer Quality of life Questionnaire core 30 (EORTC QLQ-C30) scores in patients with malignant melanoma. METHODS: Data were pooled from three published melanoma phase III trials. Anchors relying on clinician's ratings, e.g. performance status, were selected using correlation strength and clinical plausibility of associating the anchor/EORTC QLQ-C30 scale pair. HRQOL change was evaluated between time periods that were common to all trials: start of treatment to end of treatment and end of treatment to end of follow-up. Three change status groups were formed: deteriorated by one anchor category, improved by one anchor category and no change. Patients with greater anchor change were excluded. The mean change method and linear regression were used to estimate MIDs for change in HRQOL scores within the group and between the groups of patients, respectively. RESULTS: MIDs varied according to QLQ-C30 scale, direction (improvement versus deterioration), anchor and period. MIDs for within-group change ranged from 4 to 18 points (improvement) and -16 to -4 points (deterioration), and MIDs for between-group change ranged from 3 to 16 points and from -16 to -3 points. MIDs for most of QLQ-C30 scales ranged from 5 to 10 points in absolute values. CONCLUSIONS: These results are useful for interpreting changes in EORTC QLQ-C30 scores over time and for performing more accurate sample size calculations in adjuvant melanoma settings.

High level of virological suppression among HIV-infected adults receiving combination antiretroviral therapy in Addis Ababa, Ethiopia.

BACKGROUND: Plasma viral load (pVL) is a key indicator of therapeutic response in HIV-infected patients receiving combination antiretroviral therapy (cART), but is often unavailable in routine clinical care in resource-limited settings. Previous model-based simulation studies have suggested that the benefits of routine pVL monitoring among patients on first-line regimens in resource-limited settings are modest, but this needs corroboration in well-defined study populations. METHODS: We investigated virological suppression levels and identified predictors of detectable viraemia among 870 randomly selected patients who started cART between May 2009 and April 2012 in 10 health-care facilities in Addis Ababa, Ethiopia. A total of 656 (75.4%) patients, who were alive, were retained in HIV care and receiving cART for at least 6 months provided a blood sample for pVL measurement. Predictors of detectable viraemia were identified in a multivariate logistic regression model. RESULTS: In on-treatment analysis, 94.5% (95% CI 92.5, 96.1) of the patients achieved virological suppression below 400 copies/ml after a median (IQR) of 26 (17-35) months on cART. When patients who were lost to follow-up, dead or stopped were assumed to have had detectable viraemia, the proportion of patients with virological suppression <400 copies/ml decreased to 74.6% (95% CI 71.5%, 77.4%). Younger age, lower educational status, <95% medication adherence, lower CD4(+) T-cell count at cART initiation and/or the diagnosis of immunological failure thereafter significantly predicted detectable viraemia. CONCLUSIONS: Virological suppression levels can be high in an established ART programme in a resource-limited setting, even without the availability of routine pVL monitoring. Efforts to improve treatment outcomes should focus on younger and illiterate patients, earlier detection of HIV-positive status and cART initiation before patients are severely immunocompromised, and improving retention in care.

Goal adjustment strategies operationalised and empirically examined in adolescents with cancer.

Adolescents facing cancer may need to adjust their personal life goals. Theories identified several goal adjustment strategies, but their use has not been tested. Therefore, this study operationalises goal adjustment strategies and examines their use. Adolescent cancer patients listed their goals 3 and 12 months post-diagnosis. Goals received scores on five goal characteristics: life domain, level of abstraction, importance, attainability and effort. Results showed that adolescents with cancer (N = 30, mean age: 14.2 years, 60% female) used four of five strategies described in theory, while one additional strategy was found. These findings suggest that adolescents with cancer use goal adjustment strategies as measured by goal characteristics over time.

Patients with a congenital heart defect and type D personality feel functionally more impaired, report a poorer health status and quality of life, but use less healthcare.

BACKGROUND: Type D personality, characterized by high levels of negative affectivity and social inhibition, is related to mortality, morbidity, poor health status, quality of life (QoL) and less healthcare utilization in various cardiovascular patient groups. To date, studies in patients with congenital heart disease (CHD) are lacking. AIMS: (1) To examine the prevalence of type D personality in CHD patients; (2) to compare type D to non-type D patients with regard to disease severity, functional status, health status and QoL; and (3) to examine the extent to which type D personality is independently related to healthcare utilization. METHODS: A total of 1109 adult CHD patients were included in a questionnaire survey. Due to missing data, 302 patients were excluded. RESULTS: The prevalence of Type D personality was 20.4%. Type D patients reported a poorer functional status, health status and QoL than non-type D patients (p<0.05). Type D patients reported less healthcare use than non-type D patients (primary and cardiac outpatient healthcare: adjusted OR=0.56, 95% CI=0.35-0.90; inpatient healthcare: adjusted OR=0.38, 95% CI=0.17-0.83). Results of a post-hoc analysis showed a high prevalence of type D personality in patients with a poor functional status who did not consult their cardiologist. CONCLUSION: type D patients report a poorer functional status, health status and QoL, but less healthcare utilization. In clinical practice, patients should be screened for type D personality, since social inhibition may prevent them from contacting a healthcare provider in the event of symptom aggravation.