Use of medicinal plants among Ethiopian patients with diabetes: A qualitative exploration

Background: Most studies on the use of medicinal plants reported from Africa (including Ethiopia) have focused on the clinical actions of medicinal plants with little attention given to patient experiences in using these plants and factors impacting patients’ decisions about using them.Objectives: The main objective of this study is to explore the experiences of patients with diabetes attending treatment in the biomedical setting regarding their use of medicinal plants.Methods: Qualitative interviews were held with 39 purposively selected participants attending their treatment in 3 public hospitals in urban centers of central Ethiopia. Interviews continued until key themes were saturated.Results: Medicinal plants were used alongside prescribed medicines with a range of factors impacting study participants decisions to trying out and continuing to use medicinal plants and also in recommending against their use or discontinuing them. Some of the main factors that encouraged use of medicinal plants include perceptions that bitter things were thought to be good for diabetes, their claimed and experienced benefits as well as the influence of others and the media while those that discouraged the use of medicinal plants primarily include safety concerns in relation to using the plants.Conclusions: The findings highlight the use of medicinal plants by patients with diabetes in the context of limited information. This is suggestive of the need for the healthcare practitioners in the conventional healthcare system to give more attention to patients’ interest in medicinal plants and for providing more evidence-based information about the plants used by these patients so as to improve health outcomes. Key words: medicinal plants, type 2 diabetes, Ethiopia, qualitative researc

Adapting international clinical trials during COVID-19 and beyond

Background: The COVID-19 pandemic and resulting restrictions, particularly travel restrictions, have had significant impact on the conduct of global clinical trials. Our clinical trials programme, which relied on in-person visits for training, monitoring and capacity building across nine low- and middle-income countries, had to adapt to those unprecedented operational challenges. We report the adaptation of our working model with a focus on the operational areas of training, monitoring and cross-site collaboration. The new working model: Adaptations include changing training strategies from in-person site visits with three or four team members to a multi-pronged virtual approach, with generic online training for good clinical practice, the development of a library of study-specific training videos, and interactive virtual training sessions, including practical laboratory-focused training sessions. We also report changes from in-person monitoring to remote monitoring as well as the development of a more localized network of clinical trial monitors to support hybrid models with in-person and remote monitoring depending on identified risks at each site. We established a virtual network across different trial and study sites with the objective to further build capacity for good clinical practice–compliant antimalarial trials and foster cross-country and cross-study site collaboration. Conclusion: The forced adaptation of these new strategies has come with advantages that we did not envisage initially. This includes improved, more frequent engagement through the established network with opportunities for increased south-to-south support and a substantially reduced carbon footprint and budget savings. Our new approach is challenging for study sites with limited prior experience but this can be overcome with hybrid models. Capacity building for laboratory-based work remains difficult using a virtual environment. The changes to our working model are likely to last, even after the end of the pandemic, providing a more sustainable and equitable approach to our research

Ethiopian patients’ perceptions of anti-diabetic medications: implications for diabetes education

Abstract Background The purpose of this study is to explore medication-related perceptions of adult patients with type 2 diabetes attending treatment in public hospitals of urban centers in central Ethiopia. Methods Qualitative in-depth interviews were held with 39 participants selected to represent a range of treatment experiences and socio-demographic characteristics who were attending their treatment in 3 public hospitals. Interviews continued until key themes were saturated. The interview and analysis was guided by Horne’s necessity-concerns model. Results The findings revealed medication-related perceptions some of which were similar to those of Western patients and others that seem to be informed by local socio-cultural contexts. Participants’ perceptions focused on the necessity of and concerns about their anti-diabetic medications, giving more emphasis to the latter. Concerns were expressed about both perceived and experienced adverse effects, inconveniences in handling the medications and access. It was evident that some of these concerns were exaggerated but could nevertheless negatively affect adherence to prescribed medications including resistance to initiate insulin with potential impact on health outcomes. Conclusions Understanding patients’ perceptions of their medications is critical for developing a diabetes education program that considers local contexts and beliefs to enhance adherence. Education programs should consider patients’ concerns about medication adverse effects and reasons for use so as to improve their adherence and health outcomes

Explanatory models of adult patients with type 2 diabetes mellitus from urban centers of central Ethiopia

Abstract Background Type 2 diabetes, which is increasing as a public health problem in the low resource settings of Africa has been associated with the high prevalence of micro-vascular complications and increasing levels of macro-vascular complications. There is evidence from the developed world that understanding patient perceptions of chronic illness is important to design effective strategies for helping patients manage these conditions. This study utilized Kleinman’s model to explore the illness perceptions of type 2 diabetes patients attending treatment in Addis Ababa and Butajira (Ethiopia) and better understand how they manage their illness. Design Qualitative interviews were conducted to elicit the explanatory models of purposively sampled type 2 diabetes patients attending treatment in three hospitals in central Ethiopia until saturation of key emerging themes was achieved. Analysis of interview transcripts was guided by Kleinman’s model. Results A total of 39 participants, 24 from Addis Ababa and the rest from Butajira took part in the study. This study revealed that patients’ explanatory models were informed by both the traditional and biomedical models with emotional distress evident in some of the participants. The traditional model seemed to reflect the strong religious and cultural influences for the majority of study participants. The findings also revealed that symptoms played significant roles in how patients viewed their illness including assessment of its severity. Most were uncertain about the cause of their illness, with those expressing certainty citing factors over which they believed they had little or no control. This may have contributed to the perceptions about the use of religious healing and traditional medicines in a complementary or alternative manner to the biomedical regimen which could affect their adherence to recommended regimens and their health outcomes. Conclusion This study suggests the need for a strong diabetes care program that is sensitive to patients’ experiences of their illness including emotional distress. Individuals providing the diabetes care should consider local and individual contexts and strive to make their approach patient-centered and engage active participation of patients. There appears to be a need for better training of health providers in different areas including health communications and the fundamentals of mental healthcare

Barriers and facilitators to adherence to anti-diabetic medications: Ethiopian patients’ perspectives

Background: Little is known about the experiences of Ethiopian patients with type 2 diabetes related to adherence to their anti-diabetic medications. This may limit attempts to develop and implement patient-centred approaches that consider Ethiopian contexts. Objectives: To conduct an exploratory study with a focus on identifying barriers and facilitators to anti-diabetic medications adherence in Ethiopian patients with type 2 diabetes. Methods: Qualitative methods were used to conduct semi-structured interviews with 39 purposively selected participants attending clinic in three public hospitals in central Ethiopia. Open coding was used to analyse the data to identify key themes. Results: A number of factors were identified as barriers and facilitators to participants’ adherence to their anti-diabetic medications. The most common factors were perceptions related to their illness including symptoms, consequences and curability; perceptions of medications including safety concerns, convenience and their necessity; religious healing practices and beliefs; perceptions about and experiences with their healthcare providers and the healthcare system including the availability of medications and diabetes education; and finally perceived self-efficacy and social support. Conclusions: The findings of this study provide guidance to strengthen diabetes education programmes so that they reflect local patient contexts focusing among other things on the illness itself and the anti-diabetic medications

Spliced-leader RNA as a dynamic marker for monitoring viable leishmania parasites during and after treatment

Abstract: Accurate detection of viable Leishmania parasites is critical for evaluating visceral leishmaniasis (VL) treatment response at an early timepoint. We compared the decay of kinetoplast DNA (kDNA) and spliced-leader RNA (SL-RNA) in vitro, in vivo, and in a VL patient cohort. An optimized combination of blood preservation and nucleic acid extraction improved efficiency for both targets. SL-RNA degraded more rapidly during treatment than kDNA, and correlated better with microscopic examination. SL-RNA quantitative polymerase chain reaction emerges as a superior method for dynamic monitoring of viable Leishmania parasites. It enables individualized treatment monitoring for improved prognoses and has potential as an early surrogate endpoint in clinical trials. Comprehensive in vitro and in vivo experiments and analyses in patients with visceral leishmaniasis identify spliced-leader RNA (SL-RNA) as a parasite viability marker. An optimized protocol allows the versatile detection of SL-RNA and other molecular markers for individualized patient management

Reducing the risk of Plasmodium vivax after falciparum infections in co-endemic areas—a randomized controlled trial (PRIMA)

Background Plasmodium vivax forms dormant liver stages that can reactivate weeks or months following an acute infection. Recurrent infections are often associated with a febrile illness and can cause a cumulative risk of severe anaemia, direct and indirect mortality, and onward transmission of the parasite. There is an increased risk of P. vivax parasitaemia following falciparum malaria suggesting a rationale for universal use of radically curative treatment in patients with P. falciparum malaria even in the absence of detectable P. vivax parasitaemia in areas that are co-endemic for both species. Methods This is a multicentre, health care facility-based, randomized, controlled, open-label trial in Bangladesh, Indonesia and Ethiopia. Patients with uncomplicated falciparum malaria, G6PD activity of ≥70% of the adjusted male median (AMM) and haemoglobin levels ≥8g/dl are recruited into the study and randomized to either receive standard schizonticidal treatment plus 7-day high dose primaquine (total dose 7mg/kg) or standard care in a 1:1 ratio. Patients are followed up weekly until day 63. The primary endpoint is the incidence risk of any P. vivax parasitemia on day 63. Secondary endpoints include incidence risk on day 63 of symptomatic P. vivax malaria and the risk of any P. falciparum parasitaemia. Secondary safety outcomes include the proportion of adverse events and serious adverse events, the incidence risk of severe anaemia (Hb<5g/dl and <7g/dl) and/or the risk for blood transfusion, the incidence risk of ≥ 25% fall in haemoglobin with and without haemoglobinuria, and the incidence risk of ≥ 25% fall in haemoglobin to under 7g/dl with and without haemoglobinuria. Discussion This study evaluates the potential benefit of a universal radical cure for both P. vivax and P. falciparum in different endemic locations. If found safe and effective universal radical cure could represent a cost-effective approach to clear otherwise unrecognised P. vivax infections and hence accelerate P. vivax elimination. Trial registration NCT03916003. Registered on 12 April 2019

The heterogeneity of symptom reporting across study sites: a secondary analysis of a randomised placebo-controlled multicentre antimalarial trial

Abstract Introduction Symptoms reported following the administration of investigational drugs play an important role in decisions for registration and treatment guidelines. However, symptoms are subjective, and interview methods to quantify them are difficult to standardise. We explored differences in symptom reporting across study sites of a multicentre antimalarial trial, with the aim of informing trial design and the interpretation of safety and tolerability data. Methods Data were derived from the IMPROV trial, a randomised, placebo-controlled double blinded trial of high dose primaquine to prevent Plasmodium vivax recurrence conducted in eight study sites in Afghanistan, Ethiopia, Indonesia and Vietnam. At each follow up visit a 13-point symptom questionnaire was completed. The number and percentage of patients with clinically relevant symptoms following the administration of primaquine or placebo, were reported by study site including vomiting, diarrhoea, anorexia, nausea, abdominal pain and dizziness. Multivariable logistic regression was used to estimate the confounder-adjusted site-specific proportion of each symptom. Results A total of 2,336 patients were included. The greatest variation between sites in the proportion of patients reporting symptoms was for anorexia between day 0 and day 13: 97.3% (361/371) of patients in Arba Minch, Ethiopia, reported the symptom compared with 4.7% (5/106) of patients in Krong Pa, Vietnam. Differences attenuated slightly after adjusting for treatment arm, age, sex, day 0 parasite density and fever; with the adjusted proportion for anorexia ranging from 4.8% to 97.0%. Differences between sites were greater for symptoms graded as mild or moderate compared to those rated as severe. Differences in symptom reporting were greater between study sites than between treatment arms within the same study site. Conclusion Despite standardised training, there was large variation in symptom reporting across trial sites. The reporting of severe symptoms was less skewed compared to mild and moderate symptoms, which are likely to be more subjective. Trialists should clearly distinguish between safety and tolerability outcomes. Differences between trial arms were much less variable across sites, suggesting that the relative difference in reported symptoms between intervention and control group is more relevant than absolute numbers and should be reported when possible. Trial registration Clinicaltrials.gov: NCT01814683; March 20th, 2013