Dataset Information

Pre-referral Rectal Artesunate Treatment by Community-Based Treatment Providers in Ghana, Guinea-Bissau, Tanzania, and Uganda (Study 18): A Cluster-Randomized Trial.

ABSTRACT: ?If malaria patients who cannot be treated orally are several hours from facilities for injections, rectal artesunate prior to hospital referral can prevent death and disability. The goal is to reduce death from malaria by having rectal artesunate treatment available and used. How best to do this remains unknown.?Villages remote from a health facility were randomized to different community-based treatment providers trained to provide rectal artesunate in Ghana, Guinea-Bissau, Tanzania, and Uganda. Prereferral rectal artesunate treatment was provided in 272 villages: 109 through community-based health workers (CHWs), 112 via trained mothers (MUMs), 25 via trained traditional healers (THs), and 26 through trained community-chosen personnel (COMs); episodes eligible for rectal artesunate were established through regular household surveys of febrile illnesses recording symptoms eligible for prereferral treatment. Differences in treatment coverage with rectal artesunate in children aged <5 years in MUM vs CHW (standard-of-care) villages were assessed using the odds ratio (OR); the predictive probability of treatment was derived from a logistic regression analysis, adjusting for heterogeneity between clusters (villages) using random effects.?Over 19 months, 54 013 children had 102 504 febrile episodes, of which 32% (31 817 episodes) had symptoms eligible for prereferral therapy; 14% (4460) children received treatment. Episodes with altered consciousness, coma, or convulsions constituted 36.6% of all episodes in treated children. The overall OR of treatment between MUM vs CHW villages, adjusting for country, was 1.84 (95% confidence interval [CI], 1.20-2.83; P = .005). Adjusting for heterogeneity, this translated into a 1.67 higher average probability of a child being treated in MUM vs CHW villages. Referral compliance was 81% and significantly higher with CHWs vs MUMs: 87% vs 82% (risk ratio [RR], 1.1 [95% CI, 1.0-1.1]; P < .0001). There were more deaths in the TH cluster than elsewhere (RR, 2.7 [95% CI, 1.4-5.6]; P = .0040).?Prereferral episodes were almost one-third of all febrile episodes. More than one-third of patients treated had convulsions, altered consciousness, or coma. Mothers were effective in treating patients, and achieved higher coverage than other providers. Treatment access was low.?ISRCTN58046240.

SUBMITTER: Warsame M

PROVIDER: S-EPMC5146703 | biostudies-other | 2016 Dec

REPOSITORIES: biostudies-other

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Pre-referral Rectal Artesunate Treatment by Community-Based Treatment Providers in Ghana, Guinea-Bissau, Tanzania, and Uganda (Study 18): A Cluster-Randomized Trial.

Warsame Marian M Gyapong Margaret M Mpeka Betty B Rodrigues Amabelia A Singlovic Jan J Babiker Abdel A Mworozi Edison E Agyepong Irene I Ansah Evelyn E Azairwe Robert R Biai Sidu S Binka Fred F Folb Peter P Gyapong John J Kimbute Omari O Machinda Zena Z Kitua Andrew A Lutalo Tom T Majaha Melkzedik M Mamadu Jao J Mrango Zakayo Z Petzold Max M Rujumba Joseph J Ribeiro Isabela I Gomes Melba M

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20161201 suppl 5

<h4>Background</h4> If malaria patients who cannot be treated orally are several hours from facilities for injections, rectal artesunate prior to hospital referral can prevent death and disability. The goal is to reduce death from malaria by having rectal artesunate treatment available and used. How best to do this remains unknown.<h4>Methods</h4> Villages remote from a health facility were randomized to different community-based treatment providers trained to provide rectal artesunate in Ghana, ...[more]

PMID: 27941110

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Project description:BackgroundSuccessful pre-referral treatment with rectal artesunate (RA) for suspected severe malaria requires operational linkages between community health workers (CHWs) and referral facilities, acceptance of pre-referral treatment and adherence to referral practices by CHWs and caregivers. This qualitative study investigated how community understanding of the concept of 'pre-referral treatment' is used in referral related decision-making following provision of RA in Uganda.MethodsNarrative interviews were conducted with 30 caregivers of children under five who received RA within the previous three months and the 30 associated CHWs who provided the treatment. Nineteen focus group discussions incorporating vignettes from the interviews were held with further caregivers, and 12 with CHWs and women representatives. Twenty traditional healers were targeted for semi-structured interview. Thematic analysis followed a 'meaning-based' approach.ResultsCHWs were aware of essential information to be given to caregivers on prescribing RA as indicated by the job aid, specifically urgency for referral, yet there was insufficient emphasis on RA not being a full treatment for severe malaria. Information shared by the CHW appeared to be influenced by the perceived urgency with which the CHW needed to act and the time of day or night the child was seen. Seven of the 32 caregivers did not complete referral post RA administration. Caregivers seemed more likely to adhere to referral advice if they perceived their child's condition to be severe. Previous caregiver experience and CHW comparisons with Artemisinin-based Combination Therapy (ACT) as a treatment for uncomplicated malaria appeared to raise misperceptions that RA is a complete treatment for severe malaria, thus reducing likelihood to complete referral. CHW implication, or caregiver interpretation, of the need to monitor the child, and some prescription of ACT post RA administration, also confused the need for referral. Both CHWs and caregivers requested further information about the role of RA.ConclusionsCHW advice should emphasise RA as providing temporary relief prior to facility-based treatment, the importance of referral whether or not a change is seen in the child's condition, and the dangers of not completing referral. Social behaviour change communication, training and support supervision activities could help promote these messages.

Project description:BackgroundFor a full treatment course of severe malaria, community-administered pre-referral rectal artesunate (RAS) should be completed by post-referral treatment consisting of an injectable antimalarial and oral artemisinin-based combination therapy (ACT). This study aimed to assess compliance with this treatment recommendation in children under 5 years.Methods and findingsThis observational study accompanied the implementation of RAS in the Democratic Republic of the Congo (DRC), Nigeria, and Uganda between 2018 and 2020. Antimalarial treatment was assessed during admission in included referral health facilities (RHFs) in children under 5 with a diagnosis of severe malaria. Children were either referred from a community-based provider or directly attending the RHF. RHF data of 7,983 children was analysed for appropriateness of antimalarials; a subsample of 3,449 children was assessed additionally for dosage and method of ACT provision (treatment compliance). A parenteral antimalarial and an ACT were administered to 2.7% (28/1,051) of admitted children in Nigeria, 44.5% (1,211/2,724) in Uganda, and 50.3% (2,117/4,208) in DRC. Children receiving RAS from a community-based provider were more likely to be administered post-referral medication according to the guidelines in DRC (adjusted odds ratio (aOR) = 2.13, 95% CI 1.55 to 2.92, P < 0.001), but less likely in Uganda (aOR = 0.37, 95% CI 0.14 to 0.96, P = 0.04) adjusting for patient, provider, caregiver, and other contextual factors. While in DRC, inpatient ACT administration was common, ACTs were often prescribed at discharge in Nigeria (54.4%, 229/421) and Uganda (53.0%, 715/1,349). Study limitations include the unfeasibility to independently confirm the diagnosis of severe malaria due to the observational nature of the study.ConclusionsDirectly observed treatment was often incomplete, bearing a high risk for partial parasite clearance and disease recrudescence. Parenteral artesunate not followed up with oral ACT constitutes an artemisinin monotherapy and may favour the selection of resistant parasites. In connection with the finding that pre-referral RAS had no beneficial effect on child survival in the 3 study countries, concerns about an effective continuum of care for children with severe malaria seem justified. Stricter compliance with the WHO severe malaria treatment guidelines is critical to effectively manage this disease and further reduce child mortality.Trial registrationClinicalTrials.gov (NCT03568344).

Project description:BackgroundEarly and effective CPR increases both survival rate and post-arrest quality of life. In limited resource countries like Tanzania, there is scarce data describing the basic knowledge of CPR among Healthcare providers (HCP). This study aimed to determine the current level of knowledge on, and ability to perform, CPR among HCP at Muhimbili National Hospital (MNH).MethodsThis was a descriptive cross sectional study of a random sample of 350 HCP from all cadres and departments at MNH from October 2015 to March 2016. Each participant completed a with 25 question multiple choice and fill-in-the-blank CPR test and a practical test using a CPR manikin where the participant was videotaped for 1-2?min. Two expert observers independently viewed the videos and rated participant performance on a structured data form. The primary outcome of interest was staff member overall performance on the written and practical CPR testing.ResultsWe enrolled 350 HCPs from all 12 MNH clinical departments. The median participant age was 35 (IQR 29-43) years, 225 (64%) were female and 138 (39%) had clinical experience of less than 5?years. Only 57 (16%) and 88 (25%) scored above 50% in written and practical tests, respectively according to local minimum passing test score and 13(4%) and 30 (9%) scored above 75% in written and practical tests, respectively according to international minimum passing test score on CPR. The 233(67%) HCP who reported prior experience performing CPR on an adult patient scored higher on testing than those without; 40% (IQR 28-54) versus 26% (IQR 16-42) respectively, but both groups had median scores <50%.ConclusionThe level of CPR knowledge and skills displayed by all cadres and in all departments was poor despite the fact that most providers reported having performed CPR in the past. Since MNH is a tertiary referral hospital, it may reflect the performance of resuscitation status of other local health centers in Tanzania and other low-income countries to employ a formal system of training every HCP in CPR. Staff should be certified and assessed regularly to ensure retention of resuscitation knowledge and skills.

Project description:The key to reducing malaria deaths in highly endemic areas is prompt access to quality case management. Given that many severe cases occur at peripheral level, rectal artesunate (RAS) in the form of suppositories was developed in the 1990s, allowing for rapid initiation of life-saving antimalarial treatment before referral to a health facility with full case management capabilities. One randomized controlled trial published in 2009 showed a protective effect of RAS pre-referral treatment against overall mortality of 26%, but with significant differences according to study sites and length of referral. Two important issues remained unaddressed: (1) whether the mortality impact of RAS observed under controlled trial conditions could be replicated under real-world circumstances; and (2) clear operational guidance for the wide-scale implementation of RAS, including essential health system determinants for optimal impact. From 2018 to 2020, the Community Access to Rectal Artesunate for Malaria (CARAMAL) project was conducted as a large-scale observational implementation study in the Democratic Republic of the Congo (DRC), Nigeria, and Uganda (registered on ClinicalTrials.gov as NCT03568344). CARAMAL aimed to provide high-quality field evidence on the two issues above, in three remote settings with high malaria endemicity. A number of complementary study components were implemented. The core of the CARAMAL study was the Patient Surveillance System (PSS), which allowed tracking of cases of severe febrile illness from first contact at the periphery to a referral health facility, and then on to a Day 28 visit at the home of the patient. Community and provider cross-sectional surveys complemented the PSS. Here we describe in some detail RAS implementation, as well as the key CARAMAL study components and basic implementation experience. This manuscript does not intend to present key study results, but provides an extensive reference document for the companion papers describing the impact, referral process, post-referral treatment and costing of the RAS intervention.

Project description:IntroductionMaternal and perinatal deaths occurring in low and middle income countries could be prevented with timely access to maternal and new-born care. In order to increase access to maternal and child health services, a well-functioning referral system that allows for continuity of care across different tiers of healthcare is required. A reliable healthcare system, with adequate numbers of skilled staff, resources and mechanisms, is critical to ensuring that access to care is available when the need arises.Material and methodsThis descriptive, qualitative study design was used to explore barriers to implementing a reliable referral system. Twelve individual qualitative interviews were conducted with health care providers working in rural and semi-urban district hospitals in the Northern, Western, Eastern and Southern zones of Tanzania. Thematic analysis guided analysis of data.ResultsThree (3) main and interconnected themes were abstracted from the data relating to participants' experiences of referring women with obstetric complications to adequate obstetric care. These were: 1. Adhering to a rigid referral protocol; 2. Completing the referral of women to an adequate health facility and 3. Communicating the condition of the woman with obstetric complications between the referring and receiving facilities.ConclusionBecause of referral regulations, assistant medical officers were unable to make referral decisions even when they felt that a referral was needed. The lack of availability of hospital transport as well as the lack of a reliable feedback mechanism, prohibited effective referrals of patients. The Ministry of Health should revise the referral protocol to allow all clinicians to provide referrals, including assistant medical officers- who make up the majority of clinical staff in rural health care facilities. A mechanism to ensure effective communication between the referral facility and the tertiary care hospital should be instituted for quality and continuity of care. Furthermore, health care facilities should put aside budget for fuelling the ambulance for effective referrals.

Project description:INTRODUCTION:Intensive behavioral counseling is effective in preventing type 2 diabetes, and insurance coverage for such interventions is increasing. Although primary care provider referrals are not required for entry to the Centers for Disease Control and Prevention (CDC)-recognized National Diabetes Prevention Program lifestyle change program, referral rates remain suboptimal. This study aims to assess the association between primary care provider behaviors regarding prediabetes screening, testing, and referral and awareness of the CDC-recognized lifestyle change program and the Prevent Diabetes STAT: Screen, Test, and Act Today™ toolkit. Awareness of the lifestyle change program and the STAT toolkit, use of electronic health records, and the ratio of lifestyle change program classes to primary care physicians were hypothesized to be positively associated with primary care provider prediabetes screening, testing, and referral behaviors. METHODS:Responses from primary care providers (n=1,256) who completed the 2016 DocStyles cross-sectional web-based survey were analyzed in 2017 to measure self-reported prediabetes screening, testing, and referral behaviors. Multivariate logistic regression was used to estimate the effects of primary care provider awareness and practice characteristics on these behaviors, controlling for provider characteristics. RESULTS:Overall, 38% of primary care providers were aware of the CDC-recognized lifestyle change program, and 19% were aware of the STAT toolkit; 27% screened patients for prediabetes using a risk test; 97% ordered recommended blood tests; and 23% made referrals. Awareness of the lifestyle change program and the STAT toolkit was positively associated with screening and referring patients. Primary care providers who used electronic health records were more likely to screen, test, and refer. Referring was more likely in areas with more lifestyle change program classes. CONCLUSIONS:This study highlights the importance of increasing primary care provider awareness of and referrals to the CDC-recognized lifestyle change program.

Project description:When severe malaria is suspected in children, the WHO recommends pretreatment with a single rectal dose of artesunate before referral to an appropriate facility. This was an individually randomized, open-label, 2-arm, crossover clinical trial in 82 Congolese children with severe falciparum malaria to characterize the pharmacokinetics of rectal artesunate. At admission, children received a single dose of rectal artesunate (10 mg/kg of body weight) followed 12 h later by intravenous artesunate (2.4 mg/kg) or the reverse order. All children also received standard doses of intravenous quinine. Artesunate and dihydroartemisinin were measured at 11 fixed intervals, following 0- and 12-h drug administrations. Clinical, laboratory, and parasitological parameters were measured. After rectal artesunate, artesunate and dihydroartemisinin showed large interindividual variability (peak concentrations of dihydroartemisinin ranged from 5.63 to 8,090 nM). The majority of patients, however, reached previously suggested in vivo IC50 and IC90 values (98.7% and 92.5%, respectively) of combined concentrations of artesunate and dihydroartemisinin between 15 and 30 min after drug administration. The median (interquartile range [IQR]) time above IC50 and IC90 was 5.68 h (2.90 to 6.08) and 2.74 h (1.52 to 3.75), respectively. The absolute rectal bioavailability (IQR) was 25.6% (11.7 to 54.5) for artesunate and 19.8% (10.3 to 35.3) for dihydroartemisinin. The initial 12-h parasite reduction ratio was comparable between rectal and intravenous artesunate: median (IQR), 84.3% (50.0 to 95.4) versus 69.2% (45.7 to 93.6), respectively (P = 0.49). Despite large interindividual variability, rectal artesunate can initiate and sustain rapid parasiticidal activity in most children with severe falciparum malaria while they are transferred to a facility where parenteral artesunate is available. (This study has been registered at ClinicalTrials.gov under identifier NCT02492178.).

Dataset Information

Pre-referral Rectal Artesunate Treatment by Community-Based Treatment Providers in Ghana, Guinea-Bissau, Tanzania, and Uganda (Study 18): A Cluster-Randomized Trial.

Publications

Pre-referral Rectal Artesunate Treatment by Community-Based Treatment Providers in Ghana, Guinea-Bissau, Tanzania, and Uganda (Study 18): A Cluster-Randomized Trial.

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