Development and content validation of the Satisfaction and Experience Questionnaire for Granulocyte Colony-Stimulating Factor (SEQ-G-CSF).

BACKGROUND: Several options for granulocyte colony-stimulating factor (G-CSF) prophylaxis of chemotherapy-induced febrile neutropenia are available to patients worldwide. We have developed a novel patient-reported outcome measure, the Satisfaction and Experience Questionnaire for G-CSF (SEQ-G-CSF), to help understand patients' perspectives of and satisfaction with different G-CSF options. RESULTS: Three oncology nurses and 40 adult oncology patients in the United States were enrolled and participated in focus group discussions to develop and refine the SEQ-G-CSF. Nurses had ≥ 5 years of experience treating oncology patients and were currently involved in the management of oncology patients receiving G-CSF prophylaxis. The patients had breast cancer, lung cancer, non-Hodgkin lymphoma, or prostate cancer (10 patients in each group) and were receiving G-CSF prophylaxis via injection or the on-body injector (OBI) device. The preliminary SEQ-G-CSF contained an item relevance questionnaire and three SEQ modules (sociodemographic, medical history, and G-CSF-related healthcare characteristics questionnaires). Twenty-one patients (53% of total sample size) discussed their experience and satisfaction with G-CSF. Their most common experiences were G-CSF effectiveness, convenience and benefits of the OBI, and relationships with healthcare providers. Side effects and having to undergo additional treatment were also reported. Satisfaction with aspects of G-CSF included the OBI and effectiveness of G-CSF treatment; dissatisfaction included inconvenience (having to return to the clinic the next day and administration of the injection) and the insurance approval process. The SEQ-G-CSF was finalized after three rounds of cognitive interviews and includes five domains related to general satisfaction (one item), treatment burden (four items), travel burden (two items), time burden (four items), and treatment compliance (two items). CONCLUSIONS: The SEQ-G-CSF is a novel instrument that quantifies a patient's experience and satisfaction with different G-CSF options using 13 easy-to-understand items. This study provides evidence for the content validity of SEQ-G-CSF. Although further psychometric testing is required, the SEQ-G-CSF may be a useful addition to clinical trials, observational studies, and clinical practice.

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.

A Mixed-Methods Study on Acceptability, Tolerability, and Substitution of Brown Rice for White Rice to Lower Blood Glucose Levels among Nigerian Adults.

BACKGROUND: Whole-grain products such as brown rice have been associated with lower risk of metabolic disorders including diabetes. We examined the acceptability and tolerability of substituting brown rice for white rice and the feasibility of introducing brown rice into the diet through a long-term trial to lower the risk of type 2 diabetes. METHODS: Fifty-one adults residing in Abuja, Nigeria, participated in this study. Using purposeful sampling for focus group discussions (FGDs), participants were enrolled based on their age (19-25 vs. 40-60 years) and body mass index (BMI) (normal weight vs. overweight/obese). Participants tasted four meals with different constitution of brown and white rice (25:75%, 50:50%, 75:25%, and 100% brown rice). Twelve FGDs were conducted, six before and six after the food tasting. Two-hour postprandial blood glucose was measured after consumption of each rice meal. RESULTS: The mean age of the participants was 39 (±14) years, their mean BMI was 25.6 (±5.2) and about half of them were male. Most of the participants (61%) reported that rice was their main source of carbohydrate and 67% consumed rice at least five times/week. Before the food tasting, participants considered white polished rice superior to brown rice with regard to quality, taste, and nutritional value. After the food tasting, most of the participants (49%) indicated a preference for the 100% brown rice, 19% preferred the 25% brown rice, 18% preferred the 50% brown rice, and 7% preferred the 75% brown rice meals. Factors that may affect the acceptability of brown rice include its appearance, longer cooking time, cost, limited availability, and poor appreciation of its nutritional value. In general, 2-h postprandial glucose levels were lower, after consumption of meals with higher proportion of brown rice. CONCLUSION: This study provides valuable insight into the acceptability of brown rice as a substitute for white rice in Nigeria. If confirmed in larger studies, these results highlight the importance of increasing awareness on the nutritional value of brown rice and support the rationale for conducting a large-scale intervention trial to examine the effect of brown rice consumption on blood sugar levels among Nigerians.

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.

The Obesity Paradox and Heart Failure: A Systematic Review of a Decade of Evidence.

There is scientific consensus that obesity increases the risk of cardiovascular diseases, including heart failure. However, among persons who already have heart failure, outcomes seem to be better in obese persons as compared with lean persons: this has been termed the obesity paradox, the mechanisms of which remain unclear. This study systematically reviewed the evidence of the relationship between heart failure mortality (and survival) and weight status. Search of the PubMed/MEDLINE and EMBASE databases was done according to the PRISMA protocol. The initial search identified 9879 potentially relevant papers, out of which ten studies met the inclusion criteria. One study was a randomized clinical trial and 9 were observational cohort studies: 6 prospective and 3 retrospective studies. All studies used the BMI, WC, or TSF as measure of body fatness and NYHA Classification of Heart Failure and had single outcomes, death, as study endpoint. All studies included in review were longitudinal studies. All ten studies reported improved outcomes for obese heart failure patients as compared with their normal weight counterparts; worse prognosis was demonstrated for extreme obesity (BMI > 40 kg/m(2)). The findings of this review will be of significance in informing the practice of asking obese persons with heart failure to lose weight. However, any such recommendation on weight loss must be consequent upon more conclusive evidence on the mechanisms of the obesity paradox in heart failure and exclusion of collider bias.