Validation study of the Amharic version Safety Attitudes Questionnaire (SAQ) in public hospitals of Addis Ababa, Ethiopia: a cross-sectional study.

BACKGROUND: In Ethiopia, there is a growing concern about improving patients' safety in healthcare facilities. However, the lack of a valid and reliable instrument sensitive to the Ethiopian culture for measuring health professional practice environment leads to difficulty in constructing evaluations of safety climate and further linking organizational research to outcomes research. This research study examined the psychometric properties of the Safety Attitude Questionnaire (SAQ) in the Amharic language within an Ethiopian healthcare context. METHOD: A hospital-based cross-sectional study design was conducted. The SAQ was meticulously translated into Amharic using forward and backward translation methods. Content validity was evaluated with input from seven patient safety and healthcare quality experts. Face validity was established through feedback from healthcare professionals. Then, the Amharic SAQ (SAQ-A) was distributed to 648 participants working in 11 public hospitals, and a total of 611 valid questionnaires were completed and returned (95.2% response rate). Cronbach's alpha, McDonald's omega, composite reliability, correlation analysis, and average variance estimation were calculated, and confirmatory factor analysis was performed. Descriptive analyses were performed to describe socio-demographic characteristics. A P-value of ≤0.05 was considered statistically significant. Tables, figures, charts, and texts are used for data presentation. RESULT: The overall internal consistency (Cronbach's alpha) for the 31-item SAQ-A was 0.903, indicating excellent reliability. Confirmatory factor analyses demonstrated a good model fit for each dimension and the entire construct (χ2=1086.675, df=412, p<0.001, comparative fit index (CFI)=0.923, Tucker Lewis index (TLI)=0.913, and root mean square error of approximation (RMSEA)=0.052). The positive response rate of healthcare workers in hospitals was 32.1%. The positive response rates of the six dimensions were teamwork climate (59.7%), safety climate (41.9%), job satisfaction (57.1%), working conditions (37.5%), perception of management (37.6%), and stress recognition (46.2%). CONCLUSION: The Amharic translation of the SAQ showed good psychometric properties, making it a valuable tool for assessing safety attitudes among Amharic-speaking Ethiopian healthcare practitioners.

Intravenous Immunoglobulin G (IVIG) Need Assessment Survey Toward Local Manufacturing of IVIG Using a Mini-Pool Plasma Fractionation Technique.

Immunoglobulin therapy has a crucial role in the treatment of primary and secondary immunodeficiencies as well as in a multitude of neurologic, hematologic, infectious, and autoimmune conditions. In the current study, a preliminary pilot scale needs assessment survey was conducted to examine the need for IVIG among patients in Addis Ababa, Ethiopia, and in so doing justify local manufacturing of IVIG products. The survey was performed by administering a structured questionnaire to private and government hospitals, a national blood bank, a regulatory body, and healthcare researchers working in academia and pharmaceutical companies. The questionnaire encompassed demographics and specific IVIG-related questions designed for each institution. Responses supplied in the study provide qualitative data. Our findings indicated that IVIG has been registered by the regulatory body for use in Ethiopia and there is a demand for the product in the country. The study also highlights that patients go as far as to clandestine markets to procure IVIG products at a cheaper price. To impede such illegal routes and make the product readily accessible, a small-scale and low-cost approach such as a mini-pool plasma fractionation technique could be implemented to locally purify and prepare IVIG using plasma collected through the national blood donation program.

Health-Related Quality-of-Life and Associated Factors Among Children and Adolescents with Type 1 Diabetes Mellitus: A Cross-Sectional Study.

Background: Type 1 diabetes mellitus (T1DM) is one of the most common chronic diseases during childhood and adolescence. It threatens the health and endangers life with consequences for the physical and emotional development of the child and adolescent. Our study aimed at determining the health-related quality-of-life (HRQoL) and factors affecting it in children and adolescents with T1DM. Methods: A hospital-based cross-sectional study was conducted among 379 randomly selected children and adolescents, 5-18 years of age, with T1DM on follow-up at endocrine clinics from 25 August to 25 September 2021. PedsQLTM 4.0 generic core scales were used to collect the data. Paired sample t-test was used to compare children's and adolescents' self-reports and caregiver's reports. Bivariable and multivariable linear regression is used to explore to identify significant predictor factors of HRQoL. Results: Total mean score of HRQoL was 88.42±10.82 as reported by the children and adolescents and 82.17±12.65 reported by their primary caregivers. According to self-reports, age (ß=-0.197, p=0.028), mothers' educational status (ß=0.242, p<0.001), fathers' educational status (ß=0.259, p<0.001), fathers' occupation (ß=0.170, p=0.038), frequency of insulin administration (ß=-0.132, p=0.007), diabetes duration (ß=-0.101, p=0.050), and frequency of monitoring of blood glucose (ß=0.165, p=0.006) were statistically significant predictors of HRQoL, explaining 21.6% of the variability of total HRQoL scores of children and adolescents (R2=0.216, F(21,357)=5.968, p<0.001). Conclusion: Children and adolescents with T1DM in Ethiopia have relatively good HRQoL. Increased age, longer diabetes duration, and insulin administrations of three times per day were associated with decreased HRQoL scores. Educated parents, having an employed father, and frequent blood glucose monitoring were associated with higher HRQoL scores.

Twenty years of safety pharmacology model validation and the wider implications of this to drug discovery.

This editorial summarizes the content of the current themed issue of J Pharm Tox Methods derived from the 2019 Annual Safety Pharmacology Society (SPS) meeting held in Barcelona, Spain, and reflects on 20 years of innovation in the elaboration of methods for evaluating adversity, particularly during the nonclinical research phase. Given the success of safety pharmacology (SP) in the last 20 years, we propose that the rubric for SP method invention and validation be examined in more detail to explore whether it may have wider relevance to the drug discovery process. Articles arising from the Barcelona meeting are summarized here. They reflect current areas of controversy and innovation in SP. Not for the first time in recent years, the suitability of the No Observable Adverse Effect Level (NOAEL) as a variable in SP was considered in an article derived from a survey of SPS members. It was found from the survey and concluded from the analysis that the NOAEL is not necessary for assessing the safety of a New Chemical Entity (NCE). The meeting included scientific content from more than 190 abstracts (reproduced in the current volume of J Pharm Tox Methods). The impact of the INSPIRE program on the educational endeavor of SP, cardiovascular SP with regard to hERG and advances in CiPA and stem cells assays, the use of the echocardiogram in SP, the applicability of deep learning methods in SP and toxicology studies, the role of biomarkers in renal SP studies, and advances in CNS SP are highlighted in this issue of the Journal. This continued innovation reflects a rubric in SP that identifies problems, seeks solutions and, importantly, validates the solutions. If there is a lesson to be learned from the 20 years of annual SP methods themed issues it is that drug discovery efforts may benefit from a more rigorous validation process for discovery methods, using positive and negative controls for validation, as is done in SP method validation.

A 30-year bibliometric analysis of research coverage on HIV and AIDS in Lesotho.

BACKGROUND: Given the well documented undesired impacts of HIV/AIDS globally, there is a need to create a statistical inventory of research output on HIV/AIDS. This need is particularly important for a country such as Lesotho, whose HIV/AIDS prevalence is one of the highest globally. Research on HIV/AIDS in sub-Saharan Africa continues to trail behind that of other regions, especially those of the developed countries. Lesotho, a sub-Saharan country, is a developing country with lower research output in this area when longitudinally compared to other countries. This study reviewed the volume and scope of the general research output on HIV/AIDS in Lesotho and assessed the coverage of the national research agenda on HIV/AIDS, making recourse to statistical principles. METHODS: A bibliometric review of studies on HIV/AIDS retrieved from the SCOPUS and PubMed databases, published within the 30-year period between 1985 and 2016, was conducted. The focus of each of the studies was analysed and the studies were cross-matched with the national research agenda in accordance with bibliometric methodologies. RESULTS: In total, 1280 studies comprising 1181 (92.3%) journal articles, 91 (7.1%) books and 8 (0.6%) conference proceedings were retrieved. By proportion, estimation of burden of infection (40.7%) had the highest research volume, while basic (5.5%) and preventive measures (24.4%) and national planning (29.4%) had the lowest. Out of the total studies retrieved, only 516 (40.3%) matched the national research agenda. Research on maternal and child health quality of care, viral load point-of-care devices, and infant point-of-care diagnosis had hardly any publications in the high priority research category of the agenda. CONCLUSION: Notwithstanding a considerable research output on HIV/AIDS for Lesotho, there is insufficient coverage of the national research agenda in this research area. The major research gaps on general research output are in basic and preventive measures as well as national planning. There is also a need to increase targeted funding for HIV/AIDS research to appropriately address the most compelling gaps and national needs.