Assessing the feasibility of the Effectiveness of Discontinuing Bisphosphonates trial: a pilot study.

The Effectiveness of Discontinuing Bisphosphonates (EDGE) study is a planned pragmatic clinical trial to guide "drug holiday" clinical decision making. This pilot study assessed work flow and feasibility of such a study. While participant recruitment and treatment adherence were suboptimal, administrative procedures were generally feasible and minimally disrupted clinic flow. INTRODUCTION: The comparative effectiveness of continuing or discontinuing long-term alendronate (ALN) on fractures is unknown. A large pragmatic ALN discontinuation study has potential to answer this question. METHODS: We conducted a 6-month pilot study of the planned the EDGE study among current long-term ALN users (women aged ≥65 with ≥3 years of ALN use) to determine study work flow and feasibility including evaluating the administrative aspects of trial conduct (e.g., time to contract, institutional review board (IRB) approval), assessing rates of site and participant recruitment, and evaluating post-randomization outcomes, including adherence, bisphosphonate-associated adverse events, and participant and site satisfaction. We assessed outcomes 1 and 6 months after randomization. RESULTS: Nine sites participated, including seven community-based medical practices and two academic medical centers. On average (SD), contract execution took 3.4 (2.3) months and IRB approval took 13.9 (4.1) days. Sites recruited 27 participants (13 to continue ALN and 14 to discontinue ALN). Over follow-up, 22% of participants did not adhere to their randomization assignment: 30.8% in the continuation arm and 14.3% in the discontinuation arm. No fractures or adverse events were reported. Sites reported no issues regarding work flow, and participants were highly satisfied with the study. CONCLUSIONS: Administrative procedures of the EDGE study were generally feasible, with minimal disruption to clinic flow. In this convenience sample, participant recruitment was suboptimal across most practice sites. Accounting for low treatment arm adherence, a comprehensive recruitment approach will be needed to effectively achieve the scientific goals of the EDGE study.

Learning from Health Care Workers' Opinions for Improving Quality of Neonatal Health Care in Kilimanjaro Region; Northeast Tanzania

Background: There is a higher neonatal mortality rate while the adherence to the existing guidelines is rarely studied in Tanzania. Aim: The aim of this study is to assess the performance of health workers for neonatal health-care. Materials and Methods: Settings - Peripheral health facilities (regional referral; district hospitals and health centers) and a tertiary referral hospital of Kilimanjaro region; Tanzania. Fourteen hospital facilities within all seven districts of the Kilimanjaro region wer involved in this cross-sectional descriptive study. Data were collected for 5 months from 26 th November; 2010 to 25 th April; 2011. We analyzed our quantitative data by using STATA v10 (StataCorp; TX; USA) for statistical comparison using Chi-square test to test the difference between the categories and odds ratio (OR) for association between independent and dependent variables. Results: Birth asphyxia was the most recalled health problem requiring critical care; reported by 27.5 (33/120) of health-care workers (HCWs) at peripheral hospitals and at 46.4 (13/28) in a tertiary referral centers. Majority of HCWs commented on their own performance 47.5 (67/140). In the periphery (40); first comment was on management and follow-up of neonatal cases 47.5 (19/40); second on a need of skills 45 (18/40) and third on timely referrals 7.5 (18/40). Shortage of proper equipment was reported at 26.4 (37/140); shortage of staff was reported at 12.0 (17/140); lack of organization of care 11.4 (16/140) and poor hygiene at 2.9 (4/140). It was hard to judge the impact of training on the sufficiency of knowledge (OR: 2.1; 95 confidence interval: [0.9 - 4.8]; P = 0.08) although levels of knowledge for critical neonatal care were higher at the tertiary referral hospital (Pearson ?2 [2] = 53.8; P 0.001). Conclusion: Performance of HCWs in early neonatal care is suboptimal and requires frequent systematic evaluation