Generating evidence on a risk-based monitoring approach in the academic setting - lessons learned

In spite of efforts to employ risk-based strategies to increase monitoring efficiency in the academic setting, empirical evidence on their effectiveness remains sparse. This mixed-methods study aimed to evaluate the risk-based on-site monitoring approach currently followed at our academic institution.; We selected all studies monitored by the Clinical Trial Unit (CTU) according to Risk ADApted MONitoring (ADAMON) at the University Hospital Basel, Switzerland, between 01.01.2012 and 31.12.2014. We extracted study characteristics and monitoring information from the CTU Enterprise Resource Management system and from monitoring reports of all selected studies. We summarized the data descriptively. Additionally, we conducted semi-structured interviews with the three current CTU monitors.; During the observation period, a total of 214 monitoring visits were conducted in 43 studies resulting in 2961 documented monitoring findings. Our risk-based approach predominantly identified administrative (46.2%) and patient right findings (49.1%). We identified observational study design, high ADAMON risk category, industry sponsorship, the presence of an electronic database, experienced site staff, and inclusion of vulnerable study population to be factors associated with lower numbers of findings. The monitors understand the positive aspects of a risk-based approach but fear missing systematic errors due to the low frequency of visits.; We show that the factors mostly increasing the risk for on-site monitoring findings are underrepresented in the current risk analysis scheme. Our risk-based on-site approach should further be complemented by centralized data checks, allowing monitors to transform their role towards partners for overall trial quality, and success

PREVALENCE AND RISK FACTORS OF BRONCHIAL ASTHMA IN CHILDREN IN SAUDI ARABIA, A SYSTEMATIC REVIEW

Background: The results of the few epidemiological studies that have been carried out in Saudi Arabia to determine the prevalence of childhood asthma are highly inconsistent. As a result, we did a systematic literature review to assess the frequency of childhood asthma in Saudi Arabia since knowing the prevalence of common bronchial asthma in children will help doctors better grasp the scope of this health problem and inform resource planning. Objectives: This study aims to summarize current estimations of the prevalence and risk factors of bronchial asthma among children in Saudi Arabia. Methods: The PubMed database and EBSCO Information Services were utilised to choose the articles. In our review, all pertinent articles related to both our topic and other articles were used.  Other articles that were unrelated to this field were not considered. The data was extracted in a specific format, which the group members reviewed. Conclusion: Bronchial asthma prevalence rates in Saudi Arabia are increasing annually. The highest prevalence rate was found in Al Hafouf region while the lowest was reported in Abha. Risk factors were significantly associated with bronchial asthma as phycological status, smoking family member, socioeconomic status, dust, air pollution, allergens as well as other factors

Additional file 1: Figure S1. of Generating evidence on a risk-based monitoring approach in the academic setting – lessons learned

Total number (a) and proportion of findings (b/c) over time, per site. In (a), only studies (sites) with 3 or more monitoring visits are presented. Figure S2. Total number of findings over time, by individual study and site. Circles depict monitoring visit, lines connect visits at one particular site. Circles that are not connected by lines depict monitoring visits at different sites. Number 1, 7, 12, 14, 16, 19, 21, 26, 31, and 32 are multicenter studies. If different sites are not distinguishable, the total number of findings at this particular visit was the same (superposed circles). (PDF 350 kb