Evaluating implementation of Diabetes Self-Management Education in Maryland County, Liberia: protocol for a pilot prospective cohort study.

INTRODUCTION: Achieving glycaemic targets for people living with diabetes (PLWD) is challenging, especially in settings with limited resources. Programmes need to address gaps in knowledge, skills and self-management. Diabetes Self-Management Education (DSME) is an evidence-based intervention to educate and empower PLWD to improve self-management activities. This protocol describes a pilot study assessing the feasibility, acceptability and effect on clinical outcomes of implementing DSME in clinics caring for people living with insulin-dependent diabetes in Liberia. METHODS AND ANALYSIS: Our protocol is a three-phased, mixed-methods, quasi-experimental prospective cohort study. Phase 1 focuses on (a) establishing a Patient Advisory Board and (b) training providers in DSME who provide care for PLWD. In phase 2, clinicians will implement DSME. In phase 3, we will train additional providers who interact with PLWD.We will assess whether this DSME programme can lead to increased provider knowledge of DSME, improvements in diabetes self-management behaviours, glycaemic control, diabetes knowledge and psychosocial well-being, and a reduction in severe adverse events. Primary outcomes of interest are implementation outcomes and change in frequency of self-management behaviours by patients. Secondary outcomes include change in haemoglobin A1c, psychosocial well-being, severe adverse events and change in provider knowledge of DSME. ETHICS AND DISSEMINATION: Ethical approval was obtained from the University of Liberia Institutional Review Board (IRB) and the Brigham and Women's Hospital IRB. Findings from the study will be shared with local and national clinical and programmatic stakeholders and published in an open-access, peer-reviewed journal.

COAST (Cisplatin ototoxicity attenuated by aspirin trial): A phase II double-blind, randomised controlled trial to establish if aspirin reduces cisplatin induced hearing-loss.

BACKGROUND: Cisplatin is one of the most ototoxic chemotherapy drugs, resulting in a permanent and irreversible hearing loss in up to 50% of patients. Cisplatin and gentamicin are thought to damage hearing through a common mechanism, involving reactive oxygen species in the inner ear. Aspirin has been shown to minimise gentamicin-induced ototoxicity. We, therefore, tested the hypothesis that aspirin could also reduce ototoxicity from cisplatin-based chemotherapy. METHODS: A total of 94 patients receiving cisplatin-based chemotherapy for multiple cancer types were recruited into a phase II, double-blind, placebo-controlled trial and randomised in a ratio of 1:1 to receive aspirin 975 mg tid and omeprazole 20 mg od, or matched placebos from the day before, to 2 days after, their cisplatin dose(s), for each treatment cycle. Patients underwent pure tone audiometry before and at 7 and 90 days after their final cisplatin dose. The primary end-point was combined hearing loss (cHL), the summed hearing loss at 6 kHz and 8 kHz, in both ears. RESULTS: Although aspirin was well tolerated, it did not protect hearing in patients receiving cisplatin (p-value = 0.233, 20% one-sided level of significance). In the aspirin arm, patients demonstrated mean cHL of 49 dB (standard deviation [SD] 61.41) following cisplatin compared with placebo patients who demonstrated mean cHL of 36 dB (SD 50.85). Women had greater average hearing loss than men, and patients treated for head and neck malignancy experienced the greatest cHL. CONCLUSIONS: Aspirin did not protect from cisplatin-related ototoxicity. Cisplatin and gentamicin may therefore have distinct ototoxic mechanisms, or cisplatin-induced ototoxicity may be refractory to the aspirin regimen used here.