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Pre-referral rectal artesunate suppositories can save the lives of children with severe malaria if patients receive adequate post-referral care. A multi-country randomised controlled trial reporting on the efficacy of rectal artesunate informed the current WHO guidelines. In October, 2022, we reported on the findings of the Community Access to Rectal Artesunate for Malaria (CARAMAL) project, a carefully monitored roll-out of quality-assured rectal artesunate into established community-based health-care systems in DR Congo, Nigeria, and Uganda. The aim of the project was to understand the challenges involved in the successful real-world implementation of pre-referral rectal artesunate and to inform subsequent scale-up in endemic countries. In our study, we found that children treated with pre-referral rectal artesunate in routine clinical practice did not have an increased chance of survival, most likely explained by shortfalls along the continuum of care. A substantial proportion of the more than 6200 severely ill children that were followed up 28 days after treatment initiation did not receive comprehensive severe malaria care, either due to an incomplete referral to a secondary facility, or due to incomplete post-referral treatment. The observational study design allowed for a realistic assessment of the obstacles involved in implementing pre-referral rectal artesunate in settings where malaria mortality remains high. Without improving the entire continuum of care, children will continue to die from severe malaria and promising interventions will fail to meet their full potential. [ABSTRACT FROM AUTHOR]

Severe malaria is a potentially fatal condition that requires urgent treatment. In a clinical trial, a sub-group of children treated with rectal artesunate (RAS) before being referred to a health facility had an increased chance of survival. We recently published in BMC Medicine results of the CARAMAL Project that did not find the same protective effect of pre-referral RAS implemented at scale under real-world conditions in three African countries. Instead, CARAMAL identified serious health system shortfalls that impacted the entire continuum of care, constraining the effectiveness of RAS. Correspondence to the article criticized the observational study design and the alleged interpretation and consequences of our findings. Here, we clarify that we do not dispute the life-saving potential of RAS, and discuss the methodological criticism. We acknowledge the potential for confounding in observational studies. Nevertheless, the totality of CARAMAL evidence is in full support of our conclusion that the conditions under which RAS can be beneficial were not met in our settings, as children often failed to complete referral and post-referral treatment was inadequate. The criticism did not appear to acknowledge the realities of highly malarious settings documented in detail in the CARAMAL project. Suggesting that trial-demonstrated efficacy is sufficient to warrant large-scale deployment of pre-referral RAS ignores the paramount importance of functioning health systems for its delivery, for completing post-referral treatment, and for achieving complete cure. Presenting RAS as a "magic bullet" distracts from the most urgent priority: fixing health systems so they can provide a functioning continuum of care and save the lives of sick children. The data underlying our publication is freely accessible on Zenodo. [ABSTRACT FROM AUTHOR]

In this study the authors examine the relationship between "zero-dose" communities and access to healthcare services. This was done by first ensuring the first dose of the Diphtheria Tetanus and Pertussis vaccine was a better measure of zero-dose communities than the measles-containing vaccine. Once ensured, it was used to examine the association with access to primary healthcare services for children and pregnant women in the Democratic Republic of Congo, Afghanistan, and Bangladesh. These services were divided into: a) unscheduled healthcare services such as birth assistance as well as seeking care and treatment for diarrheal diseases and cough/fever episodes and b) other scheduled health services such as antenatal care visits and vitamin A supplementation. Using recent Demographic Health Survey data (2014: Democratic Republic of Congo, 2015: Afghanistan, 2018: Bangladesh), data was analyzed via Chi Squared analysis or Fischer's Exact Test. If significant, a linear regression analysis was performed to examine if the association was linear. While the linear relationship observed between children who had received the first dose of the Diphtheria Tetanus and Pertussis vaccine (the reverse to zero-dose communities) and coverage of other vaccines was expected, the results of the regression analysis depicted an unexpected split in behavior. For scheduled and birth assistance health services, a linear relationship was generally observed. For unscheduled services associated with illness treatments, this was not the case. While it does not appear that the first dose of the Diphtheria Tetanus and Pertussis vaccine can be used to predict (at least in a linear manner) access to some primary (particularly illness treatment) healthcare services in emergency/ humanitarian settings, it can serve as an indirect measure of health services not associated with the treatment of childhood infections such as antenatal care, skilled birth assistance, and to a lesser degree even vitamin A supplementation. [ABSTRACT FROM AUTHOR]

Background: Evidence suggests that pre-referral Rectal Artesunate (RAS) can be a life-saving intervention for severe malaria in remote settings in Africa. Recognition of danger signs indicative of severe malaria is critical for prompt and appropriate case management. Methods: This was an observational study conducted in three Health Zones of the Democratic Republic of the Congo to determine the distribution of dangers signs for severe malaria and assess their impact on RAS use, referral completion, injectable treatment and ACT provision, and health outcomes including death. An individual-level analysis was carried out, using multilevel-mixed effects logistic regression models. Severely ill febrile children < 5 years seeking care from community-based healthcare providers were recruited into a patient surveillance system based on the presence of key danger signs. Clinical and case management data were collected comprehensively over a 28 days period. Treatment seeking was elicited and health outcomes assessed during 28 days home visits. Results: Overall, 66.4% of patients had iCCM general danger signs. Age of 2–5 years and iCCM general danger signs predicted RAS use (aOR = 2.77, 95% CI 2.04–3.77). RAS administration positively affected referral completion (aOR = 0.63, 95% CI 0.44–0.92). After RAS rollout, 161 children died (case fatality ratio: 7.1%, 95% CI 6.1–8.2). RAS improved the health status of the children on Day 28 (aOR = 0.64, 95% CI 0.45–0.92) and there was a non-significant trend that mortality was higher in children not receiving RAS (aOR = 1.50, 95% CI 0.86–2.60). Full severe malaria treatment at the RHF including injectable anti-malarial and a course of ACT was highly protective against death (aOR = 0.26, 95% CI 0.09–0.79). Conclusions: The main findings point towards the fact that danger signs are reasonably well recognized by health provider at the primary care level, and that RAS could influence positively health outcomes of such severe disease episodes and death. Its effectiveness is hampered by the insufficient quality of care at RHF, especially the provision of a full course of ACT following parenteral treatment. These are simple but important findings that requires urgent action by the health system planners and implementers. [ABSTRACT FROM AUTHOR]