ABSTRACT
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.
ABSTRACT
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.
