Assessment of the level and factors associated with knowledge, attitude and practice of blood donation among medical and paramedical personnel in ALERT Hospital, Ethiopia.

Background: Though there was a high blood supply need in response to high communicable disease and increased emergency conditions; the practice of health professionals and non-health professionals on voluntary blood donation is still unexpectedly low in Ethiopia. Health professionals and non-health professionals working in the health sectors are pivotal in taking the lead to reverse the effect of inadequate blood supply system in the country. Therefore, the study aimed to understand the level and contributing factors of knowledge, attitude and practice of voluntary blood donation among health and non-health professionals in ALERT Hospital, Addis Ababa, Ethiopia. Design and Methods: A cross-sectional study design was conducted among health professionals and non-health professionals in ALERT hospital from 5 to 30 June 2018. A total of 394 hospital staffs participated in this study. A well-structured self-administered questionnaire was used to assess the knowledge, attitude, and practice about voluntary blood donation. The statistical analysis was carried out using R. Results: A total of 203 (51.5%) participants were females. Only 142(36%) of the participants had voluntary blood donation practice. Among these, 60 (42.3%) of them were donated blood more than once. Occupation is the only factor significantly associated with blood donation practice; health professionals had almost two-fold donation practice than non-health professionals (AOR=1.62; 5% CI: 1.02, 2.57, p=0.042). Occupation has also a strong relationship with knowledge, health professionals had better knowledge than non-professionals with (AOR=2.39; 95% CI: 1.39, 4.12; p=0.002). The result also showed that the educational status of the participants was strongly associated with the blood donors' attitude with (AOR=3.62; 95%CI: 1.1, 11.93, p=0.035). One hundred and two (72.3%) of the blood donors were motivated to donate blood for charity, 133 (94.3%) individuals were felt good after blood donation and lack of request was the major reason 88.6% that causes the respondents not to donate blood frequently. Conclusions: Low blood donation practice of health professionals and non-health professionals was identified from this study. Occupation had significantly associated with blood donation practice. Therefore, targeted interventions aimed at mobilizing hospital staffs and develop accessible blood donation centers are recommended to reverse the effect of inadequate blood supply system in Ethiopia.

Acceptability and barriers to implementation of N-of-1 tests in Ethiopia - a qualitative study.

BACKGROUND: Locally produced generic drugs offer a cost-effective alternative to imported drugs to treat patients in Ethiopia. However, due to a lack of bioequivalence testing, additional assurance tests are needed to build trust in cheaper, locally made drugs. By testing bioequivalence of local drugs to gold standard, N-of-1 tests have the potential to promote patient centred quality use of medicines. METHOD: We sought to assess the acceptability of, and explore barriers to, conducting N-of-1 tests to evaluate local medicines in a resource limited clinical setting. We conducted a descriptive qualitative study, analysing four focus group discussions and five key informant interviews. Participants were senior drug regulatory authority members, institutional review board members, physicians and patients. All interviews were audio taped and transcribed verbatim. Patient interviews were conducted in Amharic and translated to English prior to analysis. Data analysis used an inductive, thematic process. RESULTS: Five major themes were identified; (1) Appropriateness of N-of-1 tests to determine the therapeutic equivalence of local drugs, (2) N-of-1 therapeutic equivalence tests: clinical care or research? (3) Ethical and regulatory requirements (IRB), (4) Potential barriers to implementing N-of-1 tests and (5) Possible solutions to identified challenges. The study demonstrated considerable support for using N-of-1 tests for clinical equivalence studies between local and imported medicines, but important impediments were very likely to impact the feasibility of conducting N-of-1 tests in Ethiopia. Key informants from the regulatory authority did not support additional tests of local drugs. There were also mixed opinions regarding ethical requirements for conducting N-of-1 tests. The Institutional Review Board (IRB) members believed that IRB approval was sufficient to conduct N-of-1 tests, however, the regulatory authority members considered that N-of-1 tests constituted a clinical trial, and required approval at the regulatory level. CONCLUSION: This study showed that there were key uncertainties that could impact the feasiblity of using N-of-1 testing local drugs in Ethiopia. Therefore, a number of protocol amendments to address contextual threats and regulatory challenges, would be needed before progressing to conducting these tests.

Barriers for conducting clinical trials in developing countries- a systematic review.

BACKGROUND: Clinical trials for identification of efficient and effective new diagnostic and treatment modalities are needed to address disproportionately high burden of communicable (e.g., HIV/AIDS, tuberculosis, and malaria) and non-communicable diseases (e.g., diabetes) in developing countries. However, gross under-representation in global clinical trial platforms contributes to sustained health inequity in these countries. We reviewed the literature on barriers facing clinical researchers in developing countries for conducting clinical trials in their countries. METHODS: Literature indexed in PubMed, Embase, CINAHL and Web of Science, WHO Global Health Library were searched. Grey literature was also searched. Search key words included barriers, challenges, clinical trials and developing countries. Articles within the scope of this review were appraised by two reviewers. RESULTS: Ten studies, which are reported in 15 papers, were included in this review. Following critical review we identified five unifying themes for barriers. Barriers for conducting clinical trials included lack of financial and human capacity, ethical and regulatory system obstacles, lack of research environment, operational barriers and competing demands. CONCLUSION AND RECOMMENDATION: There were substantial barriers at system, organization and individual level. We propose that to address this problem, instituting a system for wider implementation of local investigator-initiated trials is warranted. These trials are more applicable to local populations because they build on local healthcare knowledge. They are more demand-led, influence policy and responsive to a country's needs because they are driven by a local or national agenda.

A series of N-of-1 trials to assess the therapeutic interchangeability of two enalapril formulations in the treatment of hypertension in Addis Ababa, Ethiopia: study protocol for a randomized controlled trial.

BACKGROUND: Hypertension is one of the leading causes of morbidity and mortality in Ethiopia. Treatment usually involves lifelong medication use. Enalapril is a common drug for the treatment of hypertension in Ethiopia. However, the drug is expensive and, therefore, there is limited capacity for people to afford the treatment. Locally produced Enalapril is a cost-effective solution to treat the disease. However, as local medicines regulation does not include bioequivalence tests on locally produced drugs, physicians and patients need assurance about the effectiveness and safety of local generics. Evidence on therapeutic equivalence is needed on these untested local drugs. METHODS: This is a hospital-based, randomized, partially blinded, three-cycle crossover trial in single patients, comparing a locally produced version of enalapril with enalapril imported from Europe. Patients involved in this trial are not blinded, as there is no local facility to produce relatively small numbers of placebos or encapsulated drugs. To ensure blinding of study investigators and data analysts, study medications are prepared by an independent pharmacy unit using opaque medication packaging. The importance of maintaining blinding is also part of patient pre-trial education. Each N-of-1 trial will consist of three successive 14-day treatment pairs, each pair comprising 7 days of 5-20 mg local and 7 days of 5-20 mg imported enalapril taken once daily in the morning. The primary outcome will be the average difference in systolic blood pressure as measured by home blood pressure measurements. DISCUSSION: The number of locally produced products, such as enalapril, being approved without proof of bioequivalence is dramatically increasing. By bridging the information gap on bioequivalence, the trial will give rigorous evidence on therapeutic equivalence of locally produced enalapril in the treatment of hypertension. If there is no difference, the hypothesized result, then patients can take the local medicine with confidence. This trial will also will determine whether aggregated N-of-1 studies are feasible to evaluate untested generic drugs in resource-limited countries where bioequivalence testing centers are unavailable. TRIAL REGISTRATION NUMBER: Australian and New Zealand Clinical Trial Registry, ID: ACTRN12616001088437p . Registered on 12 August 2016.