Clinical and demographic correlates of medication and visit adherence in a large randomized controlled trial.

BACKGROUND: Patient characteristics are associated with adherence, which has implications for planning clinical research or designing payment systems that reward superior outcomes. It is unclear to what extent clinician efforts to improve adherence can attenuate these associations. METHODS: To identify factors predicting visit and medication adherence in settings designed to optimize adherence, we did a retrospective analysis of participants in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). ALLHAT recruited participants at 632 sites in North America, Puerto Rico, and the U.S. Virgin Islands for random assignment to antihypertensive treatment with amlodipine, chlorthalidone, or lisinopril. Site investigators reported clinic characteristics at the time they applied to participate in the study and research coordinators used standardized methods to measure patient characteristics. We defined adequate visit adherence as attending at least 80 % of scheduled visits; adequate medication adherence was defined as taking 80 % or more of the randomly assigned medication at all study visits. RESULTS: The 31,250 ALLHAT participants eligible for the visit adherence analysis attended 78.5 % of scheduled study visits; 68.9 % attended more than 80 % of scheduled visits. Clinic setting was predictive of both forms of adherence; adherence was worst at private clinics; clinics that enrolled more study participants had superior adherence. Adjusting for clinic characteristics and clinical factors, women, younger participants, Blacks and smokers were less likely to have adequate visit adherence. Among the 28,967 participants eligible for the medication adherence analysis, 21,261 (73.4 %) reported adequate medication adherence. In adjusted analyses, younger and less educated participants, Blacks, and smokers were less likely to report adequate adherence. CONCLUSIONS: Participant demographics were associated with adherence despite strenuous efforts to optimize adherence. Our results could inform decisions by researchers planning trials and policymakers designing payment systems. TRIAL REGISTRATION: NCT00000542 . Registered 27 October 1999.

Cancer-related fatigue in palliative care: a global perspective.

Cancer-related fatigue (CRF) in a palliative care setting is a distressing symptom that can have a negative impact on a patient's quality of life. A range of setting- and disease-specific factors, unknown aetiology and absence of unilateral guidelines make CRF treatment a challenge for clinicians. In the absence of high-quality evidence in favour of any pharmacological and nonpharmacological measures, except exercise, cognitive behavioural therapy and psychosocial interventions, a personalised integrative oncology approach can lead to effective management. Findings suggest adoption of a severity-based symptom-stage adjusted CRF management care pathway, highlighting best practices to illustrate the lived experience of this symptom. Overcoming barriers by staff training, patient education, facilitating communication and patients' self-care, will increase CRF management effectiveness. Future CRF multisymptom or multidimensional nature investigation trials of its underlying mechanisms and new pharmacological and nonpharmacological strategies applied separately or in combination, will help reveal the best approach to CRF diagnosis, assessment and management.

Evaluation of Environmental Sample Analysis Methods and Results Reporting in the National Children's Study Vanguard Study.

During the initial Vanguard phase of the U.S. National Children's Study (NCS), about 2000 tap water, surface wipe, and air samples were collected and analyzed immediately. The shipping conditions, analysis methods, results, and laboratory performance were evaluated to determine the best approaches for use in the NCS Main Study. The main conclusions were (1) to employ established sample analysis methods, when possible, and alternate methodologies only after careful consideration with method validation studies; (2) lot control and prescreening sample collection materials are important quality assurance procedures; (3) packing samples correctly requires careful training and adjustment of shipping conditions to local conditions; (4) trip blanks and spiked samples should be considered for samplers with short expiration times and labile analytes; (5) two study-specific results reports should be required: laboratory electronic data deliverables (EDD) of sample results in a useable electronic format (CSV or SEDD XML/CSV) and a data package with sample results and supporting information in PDF format. These experiences and lessons learned can be applied to any long-term study.