Acceptability of a first-line anti-tuberculosis formulation for children: qualitative data from the SHINE trial.

SETTING: We conducted a qualitative exploration into the palatability and acceptability of a novel fixed-dose combination (FDC) anti-tuberculosis drug. This study was nested in the SHINE (Shorter treatment for minimal TB in children) trial, which compares the safety and efficacy of treating non-severe drug-susceptible tuberculosis (TB) with a 6 vs. 4 months anti-tuberculosis regimen in children aged 0-16 years. Participants were recruited in Cape Town, South Africa.OBJECTIVE: To describe the palatability and acceptability of a FDC of rifampicin, isoniazid and pyrazinamide among South African children and their caregivers in the SHINE trial.METHODS: We conducted 20 clinic observations of treatment administration, during which we conducted 16 semi-structured interviews with children and their caregivers. Data were organised thematically to report on experiences with administering and ingesting the FDC.RESULTS: Children and caregivers' experiences varied from delight to disgust. In general, participants said that the FDC compared favourably to other formulations. Pragmatic challenges such as dissolving the FDC and the time required to administer the FDC impeded caregivers' ability to integrate treatment into their daily routines. Drug manipulation was common among caregivers to improve TB treatment administration.CONCLUSION: This novel FDC appears acceptable for children, albeit with practical challenges to administration. Scale-up of FDC use should include supplementary intervention components to support caregivers.

Prevalence of eating disorder symptoms in preadolescent and adolescent girls with IDDM.

OBJECTIVE: To assess attitudinal and behavioral symptoms of eating disorders in preadolescent and adolescent girls with IDDM and a matched sample of nondiabetic subjects, and to explore the relationship between the perceived impact of IDDM and eating disorder symptoms. RESEARCH DESIGN AND METHODS: All eligible IDDM patients (girls, age 8-18 yr) from the case register of the Yale Children's Diabetes Clinic were recruited for this study. Of 49 eligible patients, 46 participated in the study. Control subjects were recruited among students in several local schools; 46 girls, individually age and race-matched with IDDM patients, and group-matched by father's socioeconomic status, were included in this study. All subjects participated in an investigator-based clinical interview (EDE) and completed a self-report measure of eating-related psychopathology (EDI). IDDM subjects completed the DQOL measure to determine the perceived impact of diabetes on patients' lives. RESULTS: IDDM patients reported significantly more regular consumption of meals and snacks than did nondiabetic subjects. No group differences were found on measures of symptoms of eating disorders: both groups reported minimal levels of symptoms. Among adolescent IDDM patients, eating disorder symptoms were related significantly to patients' dissatisfaction with the illness and its impact on their lives. CONCLUSIONS: It appears that when applying stringent diagnostic procedures and matching criteria, IDDM girls do not evidence an elevated prevalence of eating disorder symptoms. However, those IDDM patients who did report symptoms may be a high-risk group for the development of an eating disorder and should be followed prospectively.