Converting EORTC QLQ-C30 scores to utility scores in the brigatinib ALTA study.

Aims: Health utilities summarize a patient's overall health status. This study estimated utilities based on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30), a widely used measure of health-related quality-of-life (HRQoL) in oncology, using published mapping algorithms. Materials and methods: Data were from the Anaplastic Lymphoma Kinase (ALK) in Lung Cancer Trial of brigatinib (ALTA; NCT02094573), an open-label, international, phase 2 study. ALTA evaluated the efficacy and safety of two randomized dosing regimens of brigatinib in patients with locally advanced or metastatic ALK + non-small cell lung cancer (NSCLC) that had progressed on prior therapy with crizotinib. QLQ-C30 scores were mapped to European Quality-of-Life-5 Dimensions (EQ-5D) utility scores using two published algorithms (Khan et al. for EQ-5D-5L; Longworth et al. for EQ-5D-3L). The impact of brigatinib treatment on health utilities over time was assessed. Results: The analysis included 208 subjects. Mean baseline utility scores for both algorithms ranged between 0.60 - 0.71 and increased to 0.78 by cycle 5. Utility improvements were sustained during most of the treatment, before disease progression. Minor variations were observed between utility scores; Khan et al. estimates were approximately 0.01 or 0.02 points lower than Longworth et al. estimates. Limitations: Algorithms considered were limited to those available in the published literature at the time of the study. This utility analysis was exploratory, and the ALTA trial did not include an internal control group (i.e. standard of care) and was not powered to detect differences in QoL/utility outcomes between treatment arms. Conclusions: Converting QLQ-C30 scores into utilities in trials using established mapping algorithms can improve evaluation of medicines from the patient perspective. Both algorithms suggested that brigatinib improved health utility in crizotinib-refractory ALK + NSCLC patients, and improvements were maintained during most of the treatment. Clinicaltrials.gov identifier: NCT02094573.

Age, HIV status, and research context determined attrition in a longitudinal cohort in Nigeria.

OBJECTIVES: We explored determinants of attrition in a longitudinal cohort study in Nigeria. STUDY DESIGN AND SETTING: We enrolled 1,020 women into a prospective study. Of these, 973 were eligible to return for follow-up. We investigated the determinants of attrition among eligible women using a sequential mixed methods design. We used logistic regression models to compare the baseline characteristics of responders and nonresponders. At the end of the parent study, we conducted four focus group discussions and eight key informant interviews with nonresponders. RESULTS: Of the 973 women included in the quantitative analysis, 26% were nonresponders. From quantitative analysis, older women were less likely to drop out than younger women (reference: women ≤30 years; OR 0.46; 95% confidence interval [CI] 0.30-0.70, P < 0.001 women 31-44 years; and OR 0.31; 95% CI 0.17-0.56, P < 0.001 women ≥45 years). HIV-positive women were also less likely to drop out of the study (OR 0.45; 95% CI 0.33-0.63, P < 0.001). From qualitative analysis, contextual factors that influenced attrition were high cost of participation, therapeutic misconceptions, inaccurate expectations, spousal disapproval, unpleasant side effects, challenges in maintaining contact with participants, and participant difficulties in locating the study clinic. CONCLUSION: Several participant-, research-, and environment-related factors influence attrition. Retention strategies that address these barriers are important to minimize attrition.

Test-Retest Reliability of Self-Reported Sexual Behavior History in Urbanized Nigerian Women.

BACKGROUND: Studies assessing risk of sexual behavior and disease are often plagued by questions about the reliability of self-reported sexual behavior. In this study, we evaluated the reliability of self-reported sexual history among urbanized women in a prospective study of cervical HPV infections in Nigeria. METHODS: We examined test-retest reliability of sexual practices using questionnaires administered at study entry and at follow-up visits. We used the root mean squared approach to calculate within-person coefficient of variation (CVw) and calculated the intra-class correlation coefficient (ICC) using two way, mixed effects models for continuous variables and [Formula: see text] statistics for discrete variables. To evaluate the potential predictors of reliability, we used linear regression and log binomial regression models for the continuous and categorical variables, respectively. RESULTS: We found that self-reported sexual history was generally reliable, with overall ICC ranging from 0.7 to 0.9; however, the reliability varied by nature of sexual behavior evaluated. Frequency reports of non-vaginal sex (agreement = 63.9%, 95% CI: 47.5-77.6%) were more reliable than those of vaginal sex (agreement = 59.1%, 95% CI: 55.2-62.8%). Reports of time-invariant behaviors were also more reliable than frequency reports. The CVw for age at sexual debut was 10.7 (95% CI: 10.6-10.7) compared with the CVw for lifetime number of vaginal sex partners, which was 35.2 (95% CI: 35.1-35.3). The test-retest interval was an important predictor of reliability of responses, with longer intervals resulting in increased inconsistency (average change in unreliability for each 1 month increase = 0.04, 95% CI = 0.07-0.38, p = 0.005). CONCLUSION: Our findings suggest that overall, the self-reported sexual history among urbanized Nigeran women is reliable.