Adamu Addissie

Breast cancer survival in Ethiopia: a cohort study of 1,070 women.

There is little information on breast cancer (BC) survival in Ethiopia and other parts of sub‐Saharan Africa. Our study estimated cumulative probabilities of distant metastasis‐free survival (MFS) in patients at Addis Ababa (AA) University Radiotherapy Center, the only public oncologic institution in Ethiopia. We analyzed 1,070 females with BC stage 1–3 seen in 2005–2010. Patients underwent regular follow‐up; estrogen receptor‐positive and ‐unknown patients received free endocrine treatment (an independent project funded by AstraZeneca Ltd. and facilitated by the Axios Foundation). The primary endpoint was distant metastasis. Sensitivity analysis (worst‐case scenario) assumed that patients with incomplete follow‐up had events 3 months after the last appointment. The median age was 43.0 (20–88) years. The median tumor size was 4.96 cm [standard deviation (SD) 2.81 cm; n = 709 information available]. Stages 1, 2 and 3 represented 4, 25 and 71%, respectively (n = 644). Ductal carcinoma predominated (79.2%, n = 1,070) as well as grade 2 tumors (57%, n = 509). Median follow‐up was 23.1 (0–65.6) months, during which 285 women developed metastases. MFS after 2 years was 74% (69–79%), declining to 59% (53–64%) in the worst‐case scenario. Patients with early stage (1–2) showed better MFS than patients with stage 3 (85 and 66%, respectively). The 5‐year MFS was 72% for stages 1 and 2 and 33% for stage 3. We present a first overview on MFS in a large cohort of female BC patients (1,070 patients) from sub‐Saharan Africa. Young age and advanced stage were associated with poor outcome.

Cervical Cancer in Ethiopia: Survival of 1,059 Patients Who Received Oncologic Therapy

BACKGROUND Almost 500,000 women are newly diagnosed with cervical cancer (CC) every year, the majority from developing countries. There is little information on the survival of these patients. Our primary objective was to evaluate consecutive CC patients presenting over 4 years at the only radiotherapy center in Ethiopia. METHODS All patients with CC from September 2008 to September 2012 who received radiotherapy and/or surgery were included (without brachytherapy). Vital status was obtained through telephone contact or patient cards. RESULTS Of 2,300 CC patients, 1,059 patients with standardized treatment were included. At the end of the study, 249 patients had died; surviving patients had a median follow-up of 16.5 months; the 10% and 90% percentiles were 3.0 and 32.7 months, respectively. Mean age was 49 years (21-91 years). The majority of patients presented with International Federation of Gynecology and Obstetrics stage IIb-IIIa (46.7%). Because of progression during the waiting time (median 3.8 months), this proportion declined to 19.3% at the beginning of radiotherapy. The 1- and 2-year overall survival probabilities were 90.4% and 73.6%. If assuming a worst-case scenario (i.e., if all patients not available for follow-up after 6 months had died), the 2-year survival probability would be 45.4%. CONCLUSION This study gives a thorough 4-year overview of treated patients with CC in Ethiopia. Given the limited treatment availability, a relatively high proportion of patients survived 2 years. More prevention and early detection at all levels of the health care system are needed. Increasing the capacity for external-beam radiation as well as options for brachytherapy would facilitate treatment with curative intention.

A Review on Breast Cancer Care in Africa.

Background: The global incidence of breast cancer (BC) is rising, especially in low- and middle-income countries. The purpose of this review is to summarize existing publications on BC care in Africa. Patients and Methods: A systematic search in MEDLINE and smaller databases was carried out to identify African studies on BC treatment, and an additional PubMed search was performed for relevant topics on BC care. Results: A total of 219 publications, mainly from North and West Africa, were found by systematic search. We also selected articles on BC epidemiology, risk factors, clinical presentation, and cancer control in Africa. Conclusions: Publications on BC treatment are mostly from hospital case series. Evidence on treatment from prospective randomized trials that address the specific characteristics of African patients is lacking. The epidemiologic data shows rising incidences in Africa. The prevalence of risk factors is changing by age group, geographic region, and over time. The clinical picture of BC differs from that of Western countries due to the high proportion of young patients (on account of the African population with a high proportion of young people) and late presentation. Global collaborative efforts are needed to address the rising need for improved BC care in Africa.

A mixed-methods study on perceptions towards use of Rapid Ethical Assessment to improve informed consent processes for health research in a low-income setting

BackgroundRapid Ethical Assessment (REA) is a form of rapid ethnographic assessment conducted at the beginning of research project to guide the consent process with the objective of reconciling universal ethical guidance with specific research contexts. The current study is conducted to assess the perceived relevance of introducing REA as a mainstream tool in Ethiopia.MethodsMixed methods research using a sequential explanatory approach was conducted from July to September 2012, including 241 cross-sectional, self-administered and 19 qualitative, in-depth interviews among health researchers and regulators including ethics committee members in Ethiopian health research institutions and universities.ResultsIn their evaluation of the consent process, only 40.2% thought that the consent process and information given were adequately understood by study participants; 84.6% claimed they were not satisfied with the current consent process and 85.5% thought the best interests of study participants were not adequately considered. Commonly mentioned consent-related problems included lack of clarity (48.1%), inadequate information (34%), language barriers (28.2%), cultural differences (27.4%), undue expectations (26.6%) and power imbalances (20.7%). About 95.4% believed that consent should be contextualized to the study setting and 39.4% thought REA would be an appropriate approach to improve the perceived problems. Qualitative findings helped to further explore the gaps identified in the quantitative findings and to map-out concerns related to the current research consent process in Ethiopia. Suggestions included, conducting REA during the pre-test (pilot) phase of studies when applicable. The need for clear guidance for researchers on issues such as when and how to apply the REA tools was stressed.ConclusionThe study findings clearly indicated that there are perceived to be correctable gaps in the consent process of medical research in Ethiopia. REA is considered relevant by researchers and stakeholders to address these gaps. Exploring further the feasibility and applicability of REA is recommended.

International Clinical Trial Day and clinical trials in Ethiopia and Africa

Low income countries like Ethiopia are underrepresented in clinical research. As a major public commitment to clinical research, Ethiopia celebrated the International Clinical Trial Day (ICTD) for the first time on 20 May 2014 under the auspices of Addis Ababa University. The motto for the day was ‘Clinical Trials for Excellence in Patient Care’. The celebration offered an opportunity to inform academic staff, researchers, students and the leadership about clinical trials being conducted and to discuss the future of clinical trials in the country. Although clear challenges to the conduct of trials abound, clinical trials registered from Ethiopia in trial registration databases is increasing. Cross-country collaborations, international funding support, motivation of academic staff to conduct clinical trials and the commitment and engagement of the leadership in research are all improving. The overall impact of clinical trials is also encouraging. For example, some of the trials conducted in Ethiopia have informed treatment guidelines. However, administrative capacity, research infrastructure as well as financial support remain weak. There is a need for enhanced university-industry linkage and translation of research findings into locally relevant evidence. Ethiopia, as well as the whole of Africa, has an unparalleled opportunity to lead the way in clinical trials, given its prospect of development and the need to have locally relevant evidence for its growing population. In this commentary we reflect on the celebration of ICTD, the status and opportunities for conducting clinical trials and the way forward for facilitating clinical trials in Ethiopia and Africa.

Rapid Ethical Assessment on Informed Consent Content and Procedure in Hintalo-Wajirat, Northern Ethiopia: A Qualitative Study.

Background Informed consent is a key component of bio-medical research involving human participants. However, obtaining informed consent is challenging in low literacy and resource limited settings. Rapid Ethical Assessment (REA) can be used to contextualize and simplify consent information within a given study community. The current study aimed to explore the effects of social, cultural, and religious factors during informed consent process on a proposed HPV-serotype prevalence study. Methodology A qualitative community-based REA was conducted in Adigudom and Mynebri Kebeles, Northern Ethiopia, from July to August 2013. Data were collected by a multi-disciplinary team using open ended questions concerning informed consent components in relation to the parent study. The team conducted one-to-one In-Depth Interviews (IDI) and Focus Group Discussions (FGDs) with key informants and community members to collect data based on the themes of the study. Tape recorded data were transcribed in Tigrigna and then translated into English. Data were categorized and thematically analyzed using open coding and content analysis based on pre-defined themes. Results The REA study revealed a number of socio-cultural issues relevant to the proposed study. Low community awareness about health research, participant rights and cervical cancer were documented. Giving a vaginal sample for testing was considered to be highly embarrassing, whereas giving a blood sample made participants worry that they might be given a result without the possibility of treatment. Verbal consent was preferred to written consent for the proposed study. Conclusion This rapid ethical assessment disclosed important socio-cultural issues which might act as barriers to informed decision making. The findings were important for contextual modification of the Information Sheet, and to guide the best consent process for the proposed study. Both are likely to have enabled participants to understand the informed consent better and consequently to comply with the study.

Preparing for and executing a randomised controlled trial of podoconiosis treatment in Northern Ethiopia: the utility of rapid ethical assessment

Background Community-based randomized controlled trials are often complex pieces of research with significant challenges around the approach to the community, information provision, and decision-making, all of which are fundamental to the informed consent process. We conducted a rapid ethical assessment to guide the preparation for and conduct of a randomized controlled trial of podoconiosis treatment in northern Ethiopia. Methods A qualitative study was carried out in Aneded woreda, East Gojjam Zone, Amhara Regional State from August to September, 2013. A total of 14 In-depth Interviews (IDIs) with researchers, experts, and leaders, and 8 Focus Group Discussions (FGDs) involving 80 participants (people of both gender, with and without podoconiosis), were conducted. Interviews were carried out in Amharic. Data analysis was started alongside collection. Final data analysis used a thematic approach based on themes identified a priori and those that emerged during the analysis. Results Respondents made a range of specific suggestions, including that sensitisation meetings were called by woreda or kebele leaders or the police; that Health Extension Workers were asked to accompany the research team to patients’ houses; that detailed trial information was explained by someone with deep local knowledge; that analogies from agriculture and local social organisations be used to explain randomisation; that participants in the ‘delayed’ intervention arm be given small incentives to continue in the trial; and that key community members be asked to quell rumours arising in the course of the trial. Conclusion Many of these recommendations were incorporated into the preparatory phases of the trial, or were used during the course of the trial itself. This demonstrates the utility of rapid ethical assessment preceding a complex piece of research in a relatively research-naive setting.

First data from a population based cancer registry in Ethiopia

BACKGROUND The Addis Ababa City Cancer Registry, established in September 2011, is the only population-based cancer registry in Ethiopia, covering a catchment population of just over three million habitants. Herein, we report incidence data based on the first two years of registration, 2012-2013. METHODS Newly-diagnosed cancer cases in the capital city were actively collected from 22 hospitals, clinics, and diagnostic facilities. RESULTS During 2012-2013, a total of 4139 newly diagnosed cases were recorded, with the majority (67%) occurring in females. Cancers of the breast (31.5%) and cervix (14.1%) were the two most common cancers among females, while colorectal cancers (10.6%) and non-Hodgkin lymphomas (10.2%) were the most common cancers among males. The average annual age-standardized rate for all sites 2012-13 were 136.2 (per 100,000) and 70.7 in females and males, respectively. Female age-standardized rates were 40.6 for breast cancer and 21.5 for cervix, while equivalent rates in males were 7.6 per 100,000 for colorectal cancer and 6.8 per 100,000 for non-Hodgkin lymphoma. CONCLUSION In general, these incidence patterns were similar to those reported in neighboring countries, which suggests that the majority of cancer cases occurring in Addis Ababa are captured within this starting phase of the registry. However, our finding of colorectal cancer as the most commonly-diagnosed cancer in males is novel and requires further investigation.

Perceptions and experiences of pregnant women about routine HIV testing and counselling in Ghimbi town, Ethiopia: a qualitative study

BackgroundEthiopia has implemented routine HIV testing and counselling using a provider initiated HIV testing (‘opt-out’ approach) to achieve high coverage of testing and prevention of mother-to-child transmission of HIV. However, women’s perceptions and experiences with this approach have not been well studied. We conducted a qualitative study to explore pregnant women’s perceptions and experiences of routine HIV testing and counselling in Ghimbi town, Ethiopia, in May 2013. In-depth interviews were held with 28 women tested for HIV at antenatal clinics (ANC), as well as four health workers involved in routine HIV testing and counselling. Data were analyzed using the content analysis approach.ResultsWe found that most women perceived routine HIV testing and counselling beneficial for women as well as unborn babies. Some women perceived HIV testing as compulsory and a prerequisite to receive delivery care services. On the other hand, health workers reported that they try to emphasise the importance HIV testing during pre-test counselling in order to gain women’s acceptance. However, both health workers and ANC clients perceived that the pre-test counselling was limited.ConclusionsRoutine HIV testing and counselling during pregnancy is well acceptable among pregnant women in the study setting. However, there is a sense of obligation as women felt the HIV testing is a pre-requisite for delivery services. This may be related to the limited pre-test counselling. There is a need to strengthen pre-test counselling to ensure that HIV testing is implemented in a way that ensures pregnant women’s autonomy and maximize opportunities for primary prevention of HIV.

Characteristics and follow-up of metastatic breast cancer in Ethiopia: A cohort study of 573 women

OBJECTIVES There is little information on characteristics, treatment and outcome of metastatic breast cancer (mBC) patients in low-income countries. This study aims to describe mBC in the setting of Ethiopia. MATERIALS AND METHODS A retrospective cohort study was conducted among all female mBC patients from the only oncologic hospital in Addis Ababa 01/2006 to 12/2010. Time between first metastasis and known death or loss to follow-up for more than six months as surrogate for death were used for Cox proportional hazards model. RESULTS A total of 573 patients were included; 188 (32.8%) women with de novo mBC (dnmBC) and 385 women with recurrent mBC (rmBC). The average age at time of first metastasis was 43.7 (standard deviation 11.9) years with an average survival probability of twelve months. Negative hormone receptor status, only present in 29% (Hazard ratio HR = 2.28 [95% confidence interval CI 1.56-3.32] p < 0.001), and grade 3 (HR = 1.72 [95% CI 1.15-2.55] p = 0.008) had significant influence on survival. Patients with initial bone metastasis (HR = 0.63 [95% CI 0.48-0.83] p = 0.001) had best chances of survival compared to more common initial visceral metastasis. About 35% of the patients received chemotherapy and 30.5% were on endocrine therapy. CONCLUSION The lower survival for mBC in Addis Ababa compared to that from Western countries is presumably due to the later presentation at the hospital and lack of standard therapy. An unexpected high proportion of patients with hormone receptor positive mBC encourage consequent utilization of endocrine therapy to improve the quality of palliative care in this cohort.