Factors Influencing Adherence to Referral Advice Following Pre-Referral Treatment with Artesunate Suppositories in Children in Rural Tanzania

OBJECTIVE WHO recommends artemisinin suppository formulations as pre-referral treatment for children who are unable to take oral medication and cannot rapidly reach a facility for parenteral treatment. We investigated factors influencing caretakers' adherence to referral advice following pre-referral treatment of their children with rectal artesunate suppositories. METHODS The study was nested within an intervention study that involved pre-referral treatment of all children who came to a community dispenser for treatment because they were unable to take oral medications because of repeated vomiting, lethargy, convulsions or altered consciousness. All patients who did not comply with referral advice were stratified by actions taken post-referral: taking their children to a drug shop, a traditional healer, or not seeking further treatment, and added to a random selection of patients who complied with referral advice. Caretakers of the children were interviewed about their socioeconomic status (SES), knowledge about malaria, referral advice given and actions they took following pre-referral treatment. Interview data for 587 caretakers were matched with symptoms of the children, the time of treatment, arrival at a health facility or other actions taken post-pre-referral treatment. RESULTS The majority (93.5%) of caretakers reported being given referral advice by the community drug dispenser. The odds of adherence with this advice were three times greater for children with altered consciousness and/or convulsions than for children with other symptoms [odds ratio (OR) 3.47, 95% confidence interval (CI) 2.32-5.17, P < 0.001]. When questioned, caretakers who remembered when (OR 2.19, 95% CI 1.48-3.23, P < 0.001) and why (OR 1.77, 95% CI 1.07-2.95, P = 0.026) they were advised to proceed to health facility - were more likely to follow referral advice. Cost did not influence adherence except within a catchment area of facilities that charged for services. In these areas, costs deterred adherence by four to five times for those who had previously paid for laboratory services (OR = 0.25, 95% CI: 0.09-0.67, P = 0.006) or consultation (OR 0.20, 95% CI: 0.06-0.61, P = 0.005) compared with those who had not. CONCLUSION When given referral advice, caretakers of patients with life-threatening symptoms adhere to referral advice more readily than other caretakers. Health service charges deter adherence.

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Understanding Caretakers' Dilemma in Deciding Whether or Not to Adhere with Referral Advice after Pre-Referral Treatment with Rectal Artesunate
(2010) Simba, D. O.; Kakoko, D. C.; Warsame, M.; Premji, Z.; Gomes, M. F.; Tomson, G.; Johansson, E.
Background: Malaria kills. A single rectal dose of artesunate before referral can reduce mortality and prevent permanent disability. However, the success of this intervention depends on caretakers' adherence to referral advice for follow-up care. This paper explores the dilemma facing caretakers when they are in the process of deciding whether or not to transit their child to a health facility after pre-referral treatment with rectal artesunate. Methods: Four focus group discussions were held in each of three purposively selected villages in Mtwara rural district of Tanzania. Data were analysed manually using latent qualitative content analysis. Results: The theme "Caretakers dilemma in deciding whether or not to adhere with referral advice after pre-referral treatment with rectal artesunate" depicts the challenge they face. Caretakers' understanding of the rationale for going to hospital after treatment - when and why they should adhere - influenced adherence. Caretakers, whose children did not improve, usually adhered to referral advice. If a child had noticeably improved with pre-referral treatment however, caretakers weighed whether they should proceed to the facility, balancing the child's improved condition against other competing priorities, difficulties in reaching the health facilities, and the perceived quality of care at the health facility. Some misinterpretation were found regarding the urgency and rationale for adherence among some caretakers of children who improved which were attributed to be possibly due to their prior understanding. Conclusion: Some caretakers did not adhere when their children improved and some who adhered did so without understanding why they should proceed to the facility. Successful implementation of the rectal artesunate strategy depends upon effective communication regarding referral to clinic.
The Use of Placebo in a Trial of Rectal Artesunate as Initial Treatment for Severe Malaria Patients En Route to Referral Clinics : Ethical Issues
(2010) Kitua, A.; Folb, P.; Warsame, M.; Binka, F.; Faiz, A.; Ribeiro, I.; Peto, T.; Gyapong, J.; Yunus, E. B.; Rahman, R.; Baiden, F.; Clerk, C.; Mrango, Z.; Makasi, C.; Kimbute, O.; Hossain, A.; Samad, R.; Gomes, M.
Placebo-controlled trials are controversial when individuals might be denied existing beneficial medical interventions. In the case of malaria, most patients die in rural villages without healthcare facilities. An artesunate suppository that can be given by minimally skilled persons might be of value when patients suddenly become too ill for oral treatment but are several hours from a facility that can give injectable treatment for severe disease. In such situations, by default, no treatment is (or can be) given until the patient reaches a facility, making the placebo control design clinically relevant; alternative bioequivalence designs at the facility would misrepresent reality and risk incorrect conclusions. We describe the ethical issues underpinning a placebo-controlled trial in severe malaria. To protect patients and minimise risk, all patients were referred immediately to hospital so that each had a higher chance of prompt treatment through participation. There was no difference between artesunate and placebo in patients who reached clinic rapidly; among those who could not, a single artesunate suppository significantly reduced death or permanent disability, a finding of direct and indirect benefit to patients in participating villages and elsewhere.
Introducing the Concept of a New Pre-Referral Treatment for Severely Ill Febrile Children at Community Level
(BioMed Central, 2014-02-06) Vermeersch, Audrey; Libaud-Moal, Anaëlle; Rodrigues, Amabelia; White, Nicholas J.; Olliaro, Piero; Gomes, Melba; Ashley, Elizabeth A.; Millet, Pascal
Innovative strategies are needed to tackle childhood mortality in the rural tropics. Artesunate suppositories were developed to bring emergency treatment closer to severely ill children with malaria in rural areas where injectable treatment is not possible for several hours. Adding an antibacterial rectal drug would extend this strategy to treat non-malarial febrile illness as well. The objective of these studies was to assess acceptability of such a new pre-referral strategy by healthcare providers and likely uptake by the population.
Pre-Referral Rectal Artesunate to Prevent Death and Disability in Severe Malaria : A Placebo-Controlled Trial
(2009-02-14) Gomes, M. F.; Faiz, M. A.; Gyapong, J. O.; Warsame, M.; Agbenyega, T.; Babiker, A.; Baiden, F.; Yunus, E. B.; Binka, F.; Clerk, C.; Folb, P.; Hassan, R.; Hossain, M. A.; Kimbute, O.; Kitua, A.; Krishna, S.; Makasi, C.; Mensah, N.; Mrango, Z.; Olliaro, P.; Peto, R.; Peto, T. J.; Rahman, M. R.; Ribeiro, I.; Samad, R.; White, N. J.
BACKGROUND: Most malaria deaths occur in rural areas. Rapid progression from illness to death can be interrupted by prompt, effective medication. Antimalarial treatment cannot rescue terminally ill patients but could be effective if given earlier. If patients who cannot be treated orally are several hours from facilities for injections, rectal artesunate can be given before referral and acts rapidly on parasites. We investigated whether this intervention reduced mortality and permanent disability. METHODS: In Bangladesh, Ghana, and Tanzania, patients with suspected severe malaria who could not be treated orally were allocated randomly to a single artesunate (n=8954) or placebo (n=8872) suppository by taking the next numbered box, then referred to clinics at which injections could be given. Those with antimalarial injections or negative blood smears before randomisation were excluded, leaving 12 068 patients (6072 artesunate, 5996 placebo) for analysis. Primary endpoints were mortality, assessed 7-30 days later, and permanent disability, reassessed periodically. All investigators were masked to group assignment. Analysis was by intention to treat. This study is registered in all three countries, numbers ISRCTN83979018, 46343627, and 76987662. RESULTS: Mortality was 154 of 6072 artesunate versus 177 of 5996 placebo (2.5%vs 3.0%, p=0.1). Two versus 13 (0.03%vs 0.22%, p=0.0020) were permanently disabled; total dead or disabled: 156 versus 190 (2.6%vs 3.2%, p=0.0484). There was no reduction in early mortality (56 vs 51 deaths within 6 h; median 2 h). In patients reaching clinic within 6 h (median 3 h), pre-referral artesunate had no significant effect on death after 6 h or permanent disability (71/4450 [1.6%] vs 82/4426 [1.9%], risk ratio 0.86 [95% CI 0.63-1.18], p=0.35). In patients still not in clinic after more than 6 h, however, half were still not there after more than 15 h, and pre-referral rectal artesunate significantly reduced death or permanent disability (29/1566 [1.9%] vs 57/1519 [3.8%], risk ratio 0.49 [95% CI 0.32-0.77], p=0.0013). INTERPRETATION: If patients with severe malaria cannot be treated orally and access to injections will take several hours, a single inexpensive artesunate suppository at the time of referral substantially reduces the risk of death or permanent disability. FUNDING: UNICEF/UNDP/World Bank Special Programme for Research and Training in Tropical Diseases (WHO/TDR); WHO Global Malaria Programme (WHO/GMP); Sall Family Foundation; the European Union (QLRT-2000-01430); the UK Medical Research Council; USAID; Irish Aid; the Karolinska Institute; and the University of Oxford Clinical Trial Service Unit (CTSU).
Snakes and Ladders : Factors Influencing Successful Primary School Completion for Children in Poverty Contexts
(Washington, DC, 2004-09) World Bank
The World Bank (New Delhi) commissioned this qualitative study in June 2002 with the objective of exploring various factors that facilitate or impede successful primary school completion, with special reference to children living in diverse poverty situations. The study looks at children from conception to 11 years - tracking key milestones of children in diverse poverty situations in one district each in the states of Andhra Pradesh, Karnataka and Uttar Pradesh. It explores the synergy between health, education and nutritional inputs in the overall development of children in different poverty situations and reflects on whether the proximal and distal environment promotes a holistic development of the child. This study includes the following headings: executive summary; background; through the life cycle of children; emerging issues; and policy implications.

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