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1.  Adherence to treatment guidelines for acute diarrhoea in children up to 12 years in Ujjain, India - a cross-sectional prescription analysis 
Background
Diarrhoea accounts for 20% of all paediatric deaths in India. Despite WHO recommendations and IAP (Indian Academy of Paediatrics) and Government of India treatment guidelines, few children suffering from acute diarrhoea in India receive low osmolarity oral rehydration solution (ORS) and zinc from health care providers. The aim of this study was to analyse practitioners' prescriptions for acute diarrhoea for adherence to treatment guidelines and further to determine the factors affecting prescribing for diarrhoea in Ujjain, India.
Methods
This cross-sectional study was conducted in pharmacies and major hospitals of Ujjain, India. We included prescriptions from all practitioners, including those from modern medicine, Ayurveda, Homeopathy as well as informal health-care providers (IHPs). The data collection instrument was designed to include all the possible medications that are given for an episode of acute diarrhoea to children up to 12 years of age. Pharmacy assistants and resident medical officers transferred the information regarding the current diarrhoeal episode and the treatment given from the prescriptions and inpatient case sheets, respectively, to the data collection instrument.
Results
Information was collected from 843 diarrhoea prescriptions. We found only 6 prescriptions having the recommended treatment that is ORS along with Zinc, with no additional probiotics, antibiotics, racecadotril or antiemetics (except Domperidone for vomiting). ORS alone was prescribed in 58% of the prescriptions; while ORS with zinc was prescribed in 22% of prescriptions, however these also contained other drugs not included in the guidelines. Antibiotics were prescribed in 71% of prescriptions. Broad-spectrum antibiotics were prescribed and often in illogical fixed-dose combinations. One such illogical combination, ofloxacin with ornidazole, was the most frequent oral antibiotic prescribed (22% of antibiotics prescribed). Practitioners from alternate system of medicine and IHPs are significantly less likely (OR 0.13, 95% CI 0.04-0.46, P = 0.003) to prescribe ORS and zinc than pediatricians. Practitioners from 'free' hospitals are more likely to prescribe ORS and zinc (OR 4.94, 95% CI 2.45-9.96, P < 0.001) and less likely to prescribe antibiotics (OR 0.01, 95% CI 0.01-0-04, P < 0.001) compared to practitioners from 'charitable' hospitals. Accompanying symptoms like the presence of fever, pain, blood in the stool and vomiting significantly increased antibiotic prescribing.
Conclusion
This study demonstrated low adherence to standard treatment guidelines for management of acute diarrhoea in children under 12 years in Ujjain, India. Key public health concerns were the low use of zinc and the high use of antibiotics, found in prescriptions from both specialist paediatricians as well as practitioners from alternate systems of medicine and informal health-care providers. To improve case management of acute diarrhoea, continuing professional development programme targeting the practitioners of all systems of medicine is necessary.
doi:10.1186/1471-2334-11-32
PMCID: PMC3045317  PMID: 21276243
2.  Household Management of Childhood Diarrhoea: A Population-based Study in Nicaragua 
Diarrhoea remains an important cause of mortality and morbidity among children in Nicaragua. As the majority of diarrhoeal cases are treated at home and appropriate household management can lessen severity of diarrhoea, the objective of this study was to examine household management of childhood diarrhoea. A simple random sample of households was selected from the Health and Demographic Surveillance Site-León. Parents or caretakers of children below five years of age, who developed diarrhoea (n=232), were surveyed about household diarrhoea management practices in 2011. Fifty-seven percent of children received oral rehydration therapy (ORT) in the home prior to visiting any health facility. We encountered certain practices in contradiction with WHO recommendations for the management of diarrhoea in communities: 41% of children were offered protein-rich foods less frequently during diarrhoeal episodes, 20% of children were nursed less frequently or not at all during diarrhoeal episodes, and zinc supplementation was recommended at only 39% of visits with healthcare providers. Our findings provide insights for efforts to improve the household management of childhood diarrhoea in Nicaragua.
PMCID: PMC4089083  PMID: 24847604
Child; Diarrhoea; Household management; Nicaragua
3.  Diarrhoea in adults (acute) 
Clinical Evidence  2011;2011:0901.
Introduction
An estimated 4.6 billion cases of diarrhoea occurred worldwide in 2004, resulting in 2.2 million deaths.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of treatments for acute diarrhoea in adults living in resource-rich countries? What are the effects of treatments for acute mild-to-moderate diarrhoea in adults from resource-rich countries travelling to resource-poor countries? What are the effects of treatments for acute mild-to-moderate diarrhoea in adults living in resource-poor countries? What are the effects of treatments for acute severe diarrhoea in adults living in resource-poor countries? We searched: Medline, Embase, The Cochrane Library, and other important databases up to January 2010 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 72 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: antibiotics, antimotility agents, antisecretory agents, bismuth subsalicylate, diet, intravenous rehydration, nasogastric tube rehydration, oral rehydration solutions (amino acid oral rehydration solution, bicarbonate oral rehydration solution, reduced osmolarity oral rehydration solution, rice-based oral rehydration solution, standard oral rehydration solution), vitamin A supplementation, and zinc supplementation.
Key Points
Diarrhoea is an alteration in normal bowel movement, characterised by increased frequency, volume, and water content of stools, often defined clinically as an increase in stool frequency to three or more liquid or semi-formed motions in 24 hours. An estimated 4.6 billion cases of diarrhoeal illness occurred worldwide in 2004, causing 2.2 million deaths, 1.5 million of which were in children.
This review examines the effects of treatments in adults.
In people from resource-poor countries, antisecretory agents, such as racecadotril, seem to be as effective at improving symptoms of diarrhoea as antimotility agents, such as loperamide, but with fewer adverse effects. Empirical treatment with antibiotics also seems to reduce the duration of diarrhoea and improve symptoms in this population, although it can produce adverse effects such as rash, myalgia, and nausea.Instructing people to refrain from taking any solid food for 24 hours does not seem to be a useful treatment, although the evidence for this is sparse.We don't know how effective oral rehydration solutions or antibiotics plus antimotility agents are in this population, as we did not find any RCTs.
Antisecretory agents, antibiotics, and antimotility agents also seem to be effective in treating people from resource-rich countries who are travelling to resource-poor countries. Antibiotics plus antimotility agents may be more effective than antibiotics alone at reducing the duration of diarrhoea in people with travellers' diarrhoea. Bismuth subsalicylate is effective in treating travellers' diarrhoea, but less so than loperamide, and with more adverse effects (primarily black tongue and black stools).We don't know the effectiveness of oral rehydration solutions or restricting diet in reducing symptoms of diarrhoea in people travelling to resource-poor countries.
For people from resource-poor countries with mild or moderate diarrhoea, antisecretory agents seem to be as beneficial as antimotility agents, and cause fewer adverse effects (particularly rebound constipation). We didn't find sufficient evidence to allow us to judge the efficacy of antibiotics, antibiotics plus antimotility agents, or oral rehydration solutions in this population.
Oral rehydration solutions are considered to be beneficial in people from resource-poor countries who have severe diarrhoea. Studies have shown that amino acid-based and rice-based oral rehydration solutions are beneficial, but the evidence is less clear about the efficacy of bicarbonate or reduced osmolarity solutions.Rice-based oral rehydration solutions seem more beneficial compared with glucose-based oral rehydration solutions in reducing the duration of severe diarrhoea in resource-poor countries.
We don't know whether intravenous rehydration is more beneficial than oral rehydration or enteral rehydration through a nasogastric tube. We don't know whether antimotility agents, antisecretory agents, antibiotics, or antibiotics plus antimotility agents are effective for treating people with severe diarrhoea in resource-poor countries.We found no evidence on the use of zinc or vitamin A supplementation in adults in a resource-poor setting.
PMCID: PMC3217748  PMID: 21718555
4.  Increased Access to Care and Appropriateness of Treatment at Private Sector Drug Shops with Integrated Management of Malaria, Pneumonia and Diarrhoea: A Quasi-Experimental Study in Uganda 
PLoS ONE  2014;9(12):e115440.
Introduction
Drug shops are a major source of care for children in low income countries but they provide sub-standard care. We assessed the feasibility and effect on quality of care of introducing diagnostics and pre-packaged paediatric-dosage drugs for malaria, pneumonia and diarrhoea at drug shops in Uganda.
Methods
We adopted and implemented the integrated community case management (iCCM) intervention within registered drug shops. Attendants were trained to perform malaria rapid diagnostic tests (RDTs) in each fever case and count respiratory rate in each case of cough with fast/difficult breathing, before dispensing recommended treatment. Using a quasi-experimental design in one intervention and one non-intervention district, we conducted before and after exit interviews for drug seller practices and household surveys for treatment-seeking practices in May–June 2011 and May–June 2012. Survey adjusted generalized linear models and difference-in-difference analysis was used.
Results
3759 (1604 before/2155 after) household interviews and 943 (163 before/780 after) exit interviews were conducted with caretakers of children under-5. At baseline, no child at a drug shop received any diagnostic testing before treatment in both districts. After the intervention, while no child in the non-intervention district received a diagnostic test, 87.7% (95% CI 79.0–96.4) of children with fever at the intervention district drug shops had a parasitological diagnosis of malaria, prior to treatment. The prevalence ratios of the effect of the intervention on treatment of cough and fast breathing with amoxicillin and diarrhoea with ORS/zinc at the drug shop were 2.8 (2.0–3.9), and 12.8 (4.2–38.6) respectively. From the household survey, the prevalence ratio of the intervention effect on use of RDTs was 3.2 (1.9–5.4); Artemisinin Combination Therapy for malaria was 0.74 (0.65–0.84), and ORS/zinc for diarrhoea was 2.3 (1.2–4.7).
Conclusion
iCCM can be utilized to improve access and appropriateness of care for children at drug shops.
doi:10.1371/journal.pone.0115440
PMCID: PMC4277343  PMID: 25541703
5.  Application of basic pharmacology and dispensing practice of antibiotics in accredited drug-dispensing outlets in Tanzania 
Background
Provision of pharmaceutical services in accredited drug-dispensing outlets (ADDOs) in Tanzania has not been reported. This study compared the antibiotics dispensing practice between ADDOs and part II shops, or duka la dawa baridi (DLDBs), in Tanzania.
Methodology
This was a cross-sectional study that was conducted in ADDOs and DLDBs. A simulated client method for data collection was used, and a total of 85 ADDOs, located in Mvomero, Kilombero, and Morogoro rural districts, were compared with 60 DLDBs located in Kibaha district. The research assistants posed as simulated clients and requested to buy antibiotics from ADDOs and DLDBs after presenting a case scenario or disease condition. Among the diseases presented were those requiring antibiotics and those usually managed only by oral rehydration salt or analgesics. The simulated clients wanted to know the antibiotics that were available at the shop. The posed questions set a convincing ground to the dispenser either to dispense the antibiotic directly, request a prescription, or refer the patient to a health facility. Proportions were used to summarize categorical variables between ADDOs and DLDBs, and the chi-square test was used to test for statistical difference between the two drug-outlet types in terms of antibiotic-dispensing practice.
Results
As many as 40% of trained ADDO dispensers no longer worked at the ADDO shops, so some of the shops employed untrained staff. A larger proportion of ADDOs than DLDBs dispensed antibiotics without prescriptions (P = 0.004). The overall results indicate that there was no difference between the two types of shops in terms of adhering to regulations for dispensing antibiotics. However, in some circumstances, eg, antibiotic sale without prescription and no referral made, for complicated cases, ADDOs performed worse than DLDBs. As many as 30% of DLDBs and 35% of ADDOs dispensed incomplete doses of antibiotics. In both ADDOs and DLDBs, fortified procaine penicillin powder was dispensed as topical application for injuries.
Conclusion
There was no statistical difference between ADDOs and DLDBs in the violation of dispensing practice and both ADDOs and DLDBs expressed poor knowledge of the basic pharmacology of antibiotics.
doi:10.2147/DHPS.S36409
PMCID: PMC3565572  PMID: 23403610
antibiotic-dispensing practice; duka la dawa baridi; accredited drug-dispensing outlets
6.  Childhood diarrhoeal deaths in seven low- and middle-income countries 
Abstract
Objective
To investigate the clinical characteristics of children who died from diarrhoea in low- and middle-income countries, such as the duration of diarrhoea, comorbid conditions, care-seeking behaviour and oral rehydration therapy use.
Methods
The study included verbal autopsy data on children who died from diarrhoea between 2000 and 2012 at seven sites in Bangladesh, Ethiopia, Ghana, India, Pakistan, Uganda and the United Republic of Tanzania, respectively. Data came from demographic surveillance sites, randomized trials and an extended Demographic and Health Survey. The type of diarrhoea was classified as acute watery, acute bloody or persistent and risk factors were identified. Deaths in children aged 1 to 11 months and 1 to 4 years were analysed separately.
Findings
The proportion of childhood deaths due to diarrhoea varied considerably across the seven sites from less than 3% to 30%. Among children aged 1–4 years, acute watery diarrhoea accounted for 31–69% of diarrhoeal deaths, acute bloody diarrhoea for 12–28%, and persistent diarrhoea for 12–56%. Among infants aged 1–11 months, persistent diarrhoea accounted for over 30% of diarrhoeal deaths in Ethiopia, India, Pakistan, Uganda and the United Republic of Tanzania. At most sites, more than 40% of children who died from persistent diarrhoea were malnourished.
Conclusion
Persistent diarrhoea remains an important cause of diarrhoeal death in young children in low- and middle-income countries. Research is needed on the public health burden of persistent diarrhoea and current treatment practices to understand why children are still dying from the condition.
doi:10.2471/BLT.13.134809
PMCID: PMC4208570  PMID: 25378757
7.  Incidence and Clinical Characteristics of Group A Rotavirus Infections among Children Admitted to Hospital in Kilifi, Kenya  
PLoS Medicine  2008;5(7):e153.
Background
Rotavirus, predominantly of group A, is a major cause of severe diarrhoea worldwide, with the greatest burden falling on young children living in less-developed countries. Vaccines directed against this virus have shown promise in recent trials, and are undergoing effectiveness evaluation in sub-Saharan Africa. In this region limited childhood data are available on the incidence and clinical characteristics of severe group A rotavirus disease. Advocacy for vaccine intervention and interpretation of effectiveness following implementation will benefit from accurate base-line estimates of the incidence and severity of rotavirus paediatric admissions in relevant populations. The study objective was to accurately define the incidence and severity of group A rotavirus disease in a resource-poor setting necessary to make informed decisions on the need for vaccine prevention.
Methods and Findings
Between 2002 and 2004 we conducted prospective surveillance for group A rotavirus infection at Kilifi District Hospital in coastal Kenya. Children < 13 y of age were eligible as “cases” if admitted with diarrhoea, and “controls” if admitted without diarrhoea. We calculated the incidence of hospital admission with group A rotavirus using data from a demographic surveillance study of 220,000 people in Kilifi District. Of 15,347 childhood admissions 3,296 (22%) had diarrhoea, 2,039 were tested for group A rotavirus antigen and, of these, 588 (29%) were positive. 372 (63%) rotavirus-positive cases were infants. Of 620 controls 19 (3.1%, 95% confidence interval [CI] 1.9–4.7) were rotavirus positive. The annual incidence (per 100,000 children) of rotavirus-positive admissions was 1,431 (95% CI 1,275–1,600) in infants and 478 (437–521) in under-5-y-olds, and highest proximal to the hospital. Compared to children with rotavirus-negative diarrhoea, rotavirus-positive cases were less likely to have coexisting illnesses and more likely to have acidosis (46% versus 17%) and severe electrolyte imbalance except hyponatraemia. In-hospital case fatality was 2% among rotavirus-positive and 9% among rotavirus-negative children.
Conclusions
In Kilifi > 2% of children are admitted to hospital with group A rotavirus diarrhoea in the first 5 y of life. This translates into over 28,000 vaccine-preventable hospitalisations per year across Kenya, and is likely to be a considerable underestimate. Group A rotavirus diarrhoea is associated with acute life-threatening metabolic derangement in otherwise healthy children. Although mortality is low in this clinical research setting this may not be generally true in African hospitals lacking rapid and appropriate management.
Combining prospective hospital-based surveillance with demographic data in Kilifi, Kenya, James Nokes and colleagues assess the burden of rotavirus diarrhea in young children.
Editors' Summary
Background.
Rotavirus is a leading global cause of diarrhea in babies and young children. Indeed, most children become infected at least once with this virus before their fifth birthday. Rotavirus is usually spread by children or their caregivers failing to wash their hands properly after going to the toilet and then contaminating food or drink. The symptoms of rotavirus infection—diarrhea, vomiting, and fever—are usually mild, but if the diarrhea is severe it can quickly lead to dehydration. Mild to moderate dehydration can be treated at home by providing the patient with plenty of fluids or with a special rehydration drink that replaces lost water and salts. However, for infants or toddlers who become severely dehydrated, rehydration with intravenous fluids (fluids injected directly into a vein) in hospital may be essential. Unfortunately, in developing countries in sub-Saharan Africa and elsewhere, this treatment is not widely available and every year more than half a million young children die from rotavirus infections.
Why Was This Study Done?
Two rotavirus vaccines that could reduce this burden of disease are currently undergoing clinical trials to determine their effectiveness in sub-Saharan Africa. However, very little is known about the incidence of severe rotavirus infections among children living in this region (that is, how many children develop severe disease every year) or about the clinical characteristics of the disease here. Public-health officials need this baseline information before they can make informed decisions about the mass introduction of rotavirus vaccination and to help them judge whether the intervention has been successful if it is introduced. In this study, the researchers examine the incidence and clinical characteristics of rotavirus infections (specifically, group A rotavirus [GARV] infections; there are several different rotaviruses but GARV causes most human infections) among children admitted to the district hospital in Kilifi, Kenya.
What Did the Researchers Do and Find?
During the 3-year study, more than 15,000 children under the age of 13 years were admitted to Kilifi District Hospital, a little under a quarter of whom had severe diarrhea. Nearly a third of the patients admitted with diarrhea who were tested had a GARV-specific protein in their stools (faeces); by contrast, only three in 100 children admitted without diarrhea showed any evidence of GARV infection. Two-thirds of the GARV-positive children were infants (under 1 year old). Using these figures and health surveillance data (records of births, deaths, and causes of death) collected in the area around the hospital, the researchers calculated that the annual incidence (per 100,000 children) of GARV-positive hospital admissions in the region was 1,431 for infants and 478 for children under age 5 years. Children with GARV-positive diarrhea were less likely to have other illnesses (for example, malnutrition) than those admitted with GARV-negative diarrhea, the researchers report, but were more likely to have life-threatening complications such as severe dehydration and salt imbalances in their blood. However, despite being more ill on admission, only 1 in 50 children with GARV-positive diarrhea died, compared to nearly 1 in 10 of the children with GARV-negative diarrhea; the GARV-positive children also left hospital quicker than those who were GARV-negative.
What Do These Findings Mean?
These findings indicate that severe GARV-positive diarrhea is a major cause of hospital admission among otherwise healthy young children in the Kilifi region of Kenya. By the time they are 5 years old, the researchers estimate that 1 in 50 of the children living in this region will have been admitted to hospital with severe GARV-positive diarrhea. Because rotavirus vaccines prevent virtually all severe rotavirus-associated disease (at least in developed countries where their effectiveness has been extensively tested), the researchers estimate that vaccination might prevent more than 28,000 hospitalizations annually across Kenya; however, this prediction assumes that it is valid to extrapolate from the data obtained from this one district hospital to the entire country.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0050153.
The US Centers for Disease Control and Prevention provides information about rotavirus infections, surveillance, and vaccination (in English and Spanish)
The UK National Health Service Direct health encyclopedia provides information on rotavirus infections
MedlinePlus also provides links to information on rotavirus (in English and Spanish)
The African Rotavirus Surveillance Network is working to improve knowledge about rotavirus infections in Africa
The Rotavirus Vaccine Program aims to reduce child illness and death from diarrhea by increasing the availability of rotavirus vaccines in developing countries (in English and Spanish)
PATH, a nonprofit international organization that aims to create sustainable, culturally relevant solutions to global health problems, also provides detailed information on rotavirus surveillance and disease burden
doi:10.1371/journal.pmed.0050153
PMCID: PMC2488191  PMID: 18651787
8.  Operational Issues and Trends Associated with the Pilot Introduction of Zinc for Childhood Diarrhoea in Bougouni District, Mali 
Zinc for the treatment of childhood diarrhoea was introduced in a pilot area in southern Mali to prepare for a cluster-randomized effectiveness study and to inform policies on how to best introduce and promote zinc at the community level. Dispersible zinc tablets in 14-tablet blister packs were provided through community health centres and drug kits managed by community health workers (CHWs) in two health zones in Bougouni district, Mali. Village meetings and individual counselling provided by CHWs and head nurses at health centres were the principal channels of communication. A combination of methods were employed to (a) detect problems in communication about the benefits of zinc and its mode of administration; (b) identify and resolve obstacles to implementation of zinc through existing health services; and (c) describe household-level constraints to the adoption of appropriate home-management practices for diarrhoea, including administration of both zinc and oral rehydration solution (ORS). Population-based household surveys with caretakers of children sick in the previous two weeks were carried out before and four months after the introduction of zinc supplementation. Household follow-up visits with children receiving zinc from the health centres and CHWs were conducted on day 3 and 14 after treatment for a subsample of children. A qualitative process evaluation also was conducted to investigate operational issues. Preliminary evidence from this study suggests that the introduction of zinc does not reduce the use of ORS and may reduce inappropriate antibiotic use for childhood diarrhoea. Financial access to treatments, management of concurrent diarrhoea and fever, and high use of unauthorized drug vendors were identified as factors affecting the effectiveness of the intervention in this setting. The introduction of zinc, if not appropriately integrated with other disease-control strategies, has the potential to decrease the appropriate presumptive treatment of childhood malaria in children with diarrhoea and fever in malaria-endemic areas.
PMCID: PMC2740667  PMID: 18686549
Antibiotic use; Diarrhoea; Child health; Oral rehydration solutions; Oral rehydration therapy; Zinc; Zinc therapy; Mali
9.  Private Sector Drug Shops in Integrated Community Case Management of Malaria, Pneumonia, and Diarrhea in Children in Uganda 
We conducted a survey involving 1,604 households to determine community care-seeking patterns and 163 exit interviews to determine appropriateness of treatment of common childhood illnesses at private sector drug shops in two rural districts of Uganda. Of children sick within the last 2 weeks, 496 (53.1%) children first sought treatment in the private sector versus 154 (16.5%) children first sought treatment in a government health facility. Only 15 (10.3%) febrile children treated at drug shops received appropriate treatment for malaria. Five (15.6%) children with both cough and fast breathing received amoxicillin, although no children received treatment for 5–7 days. Similarly, only 8 (14.3%) children with diarrhea received oral rehydration salts, but none received zinc tablets. Management of common childhood illness at private sector drug shops in rural Uganda is largely inappropriate. There is urgent need to improve the standard of care at drug shops for common childhood illness through public–private partnerships.
doi:10.4269/ajtmh.2012.11-0791
PMCID: PMC3748528  PMID: 23136283
10.  Treatment of Diarrhoea in Rural African Communities: An Overview of Measures to Maximise the Medicinal Potentials of Indigenous Plants 
Diarrhoea is a major cause of morbidity and mortality in rural communities in Africa, particularly in children under the age of five. This calls for the development of cost effective alternative strategies such as the use of herbal drugs in the treatment of diarrhoea in these communities. Expenses associated with the use of orthodox medicines have generated renewed interest and reliance on indigenous medicinal plants in the treatment and management of diarrhoeal infections in rural communities. The properties of many phenolic constituents of medicinal plants such as their ability to inhibit enteropooling and delay gastrointestinal transit are very useful in the control of diarrhoea, but problems such as scarcity of valuable medicinal plants, lack of standardization of methods of preparation, poor storage conditions and incertitude in some traditional health practitioners are issues that affect the efficacy and the practice of traditional medicine in rural African communities. This review appraises the current strategies used in the treatment of diarrhoea according to the Western orthodox and indigenous African health-care systems and points out major areas that could be targeted by health-promotion efforts as a means to improve management and alleviate suffering associated with diarrhoea in rural areas of the developing world. Community education and research with indigenous knowledge holders on ways to maximise the medicinal potentials in indigenous plants could improve diarrhoea management in African rural communities.
doi:10.3390/ijerph9113911
PMCID: PMC3524604  PMID: 23202823
diarrhea; gastrointestinal transit; indigenous medicinal plants; health-promotion efforts; rural Africa
11.  Getting closer to people: family planning provision by drug shops in Uganda 
Private drug shops can effectively provide contraceptive methods, especially injectables, complementing government services. Most drug shop clients in 4 peri-urban areas of Uganda were continuing users of DMPA; had switched from other providers, mainly government clinics, because the drug shops had fewer stock-outs and were more convenient (closer location, shorter waiting time, more flexible hours); and were satisfied with the quality of services. The drug shops provided a substantial part of the total market share for family planning services in their areas.
Private drug shops can effectively provide contraceptive methods, especially injectables, complementing government services. Most drug shop clients in 4 peri-urban areas of Uganda were continuing users of DMPA; had switched from other providers, mainly government clinics, because the drug shops had fewer stock-outs and were more convenient (closer location, shorter waiting time, more flexible hours); and were satisfied with the quality of services. The drug shops provided a substantial part of the total market share for family planning services in their areas.
ABSTRACT
Background:
Private-sector drug shops are often the first point of health care in sub-Saharan Africa. Training and supporting drug shop and pharmacy staff to provide a wide range of contraceptive methods and information is a promising high-impact practice for which more information is needed to fully document implementation experience and impact.
Methods:
Between September 2010 and March 2011, we trained 139 drug shop operators (DSOs) in 4 districts of Uganda to safely administer intramuscular DMPA (depot medroxyprogesterone acetate) contraceptive injections. In 2012, we approached 54 of these DSOs and interviewed a convenience sample of 585 of their family planning clients to assess clients' contraceptive use and perspectives on the quality of care and satisfaction with services. Finally, we compared service statistics from April to June 2011 from drug shops, community health workers (CHWs), and government clinics in 3 districts to determine the drug shop market share of family planning services.
Results:
Most drug shop family planning clients interviewed were women with low socioeconomic status. The large majority (89%) were continuing family planning users. DMPA was the preferred contraceptive. Almost half of the drug shop clients had switched from other providers, primarily from government health clinics, mostly as a result of more convenient locations, shorter waiting times, and fewer stock-outs in drug shops. All clients reported that the DSOs treated them respectfully, and 93% trusted the drug shop operator to maintain privacy. Three-quarters felt that drug shops offered affordable family planning services. Most of the DMPA clients (74%) were very satisfied with receiving their method from the drug shop and 98% intended to get the next injection from the drug shop. Between April and June 2011, clinics, CHWs, and drug shops in 3 districts delivered equivalent proportions of couple-years of protection, with drug shops leading marginally at 36%, followed by clinics (33%) and CHWs (31%).
Conclusion:
Drug shops can be a viable and convenient source of short-acting contraceptive methods, including DMPA, serving as a complement to government services. Family planning programs in Uganda and elsewhere should consider including drug shops in the network of community-based family planning providers.
doi:10.9745/GHSP-D-14-00085
PMCID: PMC4307862  PMID: 25611480
12.  Diarrhoea in adults (acute) 
Clinical Evidence  2008;2008:0901.
Introduction
An estimated 4000 million cases of diarrhoea occurred worldwide in 1996, resulting in 2.5 million deaths.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of treatments for acute diarrhoea in adults living in resource-rich countries? What are the effects of treatments for acute mild-to-moderate diarrhoea in adults from resource-rich countries traveling to resource-poor countries? What are the effects of treatments for acute mild-to-moderate diarrhoea in adults living in resource-poor countries? What are the effects of treatments for acute severe diarrhoea in adults living in resource-poor countries? We searched: Medline, Embase, The Cochrane Library and other important databases up to January 2007 (BMJ Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 71 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: antibiotics, antimotility agents, antisecretory agents, bismuth subsalicylate, diet, intravenous rehydration, nasogastric tube rehydration, and oral rehydration solutions (amino acid oral rehydration solution, bicarbonate oral rehydration solution, reduced osmolarity oral rehydration solution, rice-based oral rehydration solution, standard oral rehydration solution).
Key Points
Diarrhoea is watery or liquid stools, usually with an increase in stool weight above 200 g daily and an increase in daily stool frequency. An estimated 4000 million cases of diarrhoea occurred worldwide in 1996, resulting in 2.5 million deaths.
In people from resource-poor countries, antisecretory agents, such as racecadotril, seem to be as effective at improving symptoms of diarrhoea as antimotility agents, such as loperamide, but with fewer adverse effects. Empirical treatment with antibiotics also seems to reduce the duration of diarrhoea and improve symptoms in this population, although it can produce adverse effects such as rash, myalgia, and nausea.Instructing people to refrain from taking any solid food for 24 hours does not appear to be a useful treatment, although the evidence for this is sparse.We don't know how effective oral rehydration solutions or antibiotics plus antimotility agents are in this population, as we did not find any RCTs.
Antisecretory agents, antibiotics, and antimotility agents also appear to be effective in treating people from resource-rich countries who are travelling to resource-poor countries. We don't know whether antibiotics plus antimotility agents are more effective than either treatment alone or placebo. Bismuth subsalicylate is effective in treating travellers' diarrhoea, but less so than loperamide, and with more adverse effects (primarily black tongue and black stools).We don't know the effectiveness of oral rehydration solutions or restricting diet in reducing symptoms of diarrhoea in people travelling to resource-poor countires.
For people from resource-poor countires with mild or moderate diarrhoea, antisecretory agents seem to be as beneficial as antimotility agents, and cause fewer adverse effects (particularly rebound constipation). We didn't find sufficient evidence to allow us to judge the efficacy of antibiotics, antibiotics plus antimotility agents, or oral rehydration solutions in this population.
Oral rehydration solutions are considered to be beneficial in people from resource-poor countries who have severe diarrhoea. Studies have shown that amino acid-based and rice-based oral rehydration solutions are beneficial, but the evidence is less clear about the efficacy of bicarbonate or reduced osmolarity solutions.
We don't know whether intravenous rehydration is more beneficial than oral rehydration or enteral rehydration through a nasogastric tube. We don't know whether antimotility agents, antisecretory agents, antibiotics, or antiobiotics plus antimotility agents are effective for treating people with severe diarrhoea in resource-poor countries.
PMCID: PMC2907942  PMID: 19450323
13.  Impact Monitoring of the National Scale Up of Zinc Treatment for Childhood Diarrhea in Bangladesh: Repeat Ecologic Surveys 
PLoS Medicine  2009;6(11):e1000175.
Charles Larson and colleagues find that 23 months into a national campaign to scale up zinc treatment for diarrhea in children under age 5 years, only 10% of children with diarrhea in rural areas and 20%–25% in urban/municipal areas were getting the treatment.
Background
Zinc treatment of childhood diarrhea has the potential to save 400,000 under-five lives per year in lesser developed countries. In 2004 the World Health Organization (WHO)/UNICEF revised their clinical management of childhood diarrhea guidelines to include zinc. The aim of this study was to monitor the impact of the first national campaign to scale up zinc treatment of childhood diarrhea in Bangladesh.
Methods/Findings
Between September 2006 to October 2008 seven repeated ecologic surveys were carried out in four representative population strata: mega-city urban slum and urban nonslum, municipal, and rural. Households of approximately 3,200 children with an active or recent case of diarrhea were enrolled in each survey round. Caretaker awareness of zinc as a treatment for childhood diarrhea by 10 mo following the mass media launch was attained in 90%, 74%, 66%, and 50% of urban nonslum, municipal, urban slum, and rural populations, respectively. By 23 mo into the campaign, approximately 25% of urban nonslum, 20% of municipal and urban slum, and 10% of rural under-five children were receiving zinc for the treatment of diarrhea. The scale-up campaign had no adverse effect on the use of oral rehydration salt (ORS).
Conclusions
Long-term monitoring of scale-up programs identifies important gaps in coverage and provides the information necessary to document that intended outcomes are being attained and unintended consequences avoided. The scale-up of zinc treatment of childhood diarrhea rapidly attained widespread awareness, but actual use has lagged behind. Disparities in zinc coverage favoring higher income, urban households were identified, but these were gradually diminished over the two years of follow-up monitoring. The scale up campaign has not had any adverse effect on the use of ORS.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Diarrheal disease is a significant global health problem with approximately 4 billion cases and 2.5 million deaths annually. The overwhelming majority of cases are in developing countries where there is a particularly high death rate among children under five years of age. Diarrhea is caused by bacterial, parasitic, or viral pathogens, which often spread in contaminated water. Poor hygiene and sanitation, malnutrition, and lack of medical care all contribute to the burden of this disease. Replacing lost fluids and salts is a cheap and effective method to rehydrate people following dehydration caused by diarrhea. Clinical trials show that zinc, as part of a treatment for childhood diarrhea, not only helps to reduce the severity and duration of diarrhea but also reduces the likelihood of a repeat episode in the future. Zinc is now included in the guidelines by the World Health Organization (WHO)/UNICEF for treatment of childhood diarrhea.
Why Was This Study Done?
Zinc treatment together with traditional oral rehydration salts therapy following episodes of diarrhea could potentially benefit millions of children in areas where diarrheal disease is prevalent. The “Scaling Up of Zinc for Young Children” (SUZY) project was established in 2003 to provide zinc treatment for diarrhea in all children under five years of age in Bangladesh. The project was supported by a partnership of public, private, nongovernmental organization, and multinational sector agencies during its scale up to a national campaign across Bangladesh. The partners helped to develop the scale-up campaign, produce and distribute zinc tablets, train health professionals to provide zinc treatment, and create media campaigns (such as advertisements in TV, radio, and newspapers) to raise awareness and promote the use of zinc for diarrhea. The researchers wanted to monitor how effective and successful the national campaign was at promoting zinc treatment for childhood diarrhea. Also, they wanted to highlight any potential problems during the implementation of health care initiatives in areas with deprived health systems.
What Did the Researchers Do and Find?
The researchers set up survey sites to monitor results from the first two years of the SUZY campaign. Four areas, each representing different segments of the population across Bangladesh were surveyed; urban slums, urban nonslums, municipal (small city), and rural. There are approximately 1.5 million children under the age of five across these sites. Households in each survey site were selected at random, and seven surveys were conducted at each site between September 2006 and October 2008—about 3,200 children with diarrhea for each survey. Over 90% of parents used private sector providers of drug treatment so the campaign focused on distribution of zinc tablets in the private sector. They were also available free of charge in the public health sector. TV and radio campaigns for zinc treatment rapidly raised awareness across Bangladesh. Awareness was less than 10% in all communities prelaunch and peaked 10 months later at 90%, 74%, 66%, and 50% in urban nonslum, municipal, urban slum, and rural sites, respectively. However, after 23 months only 25% of urban nonslum, 20% of municipal and urban slum, and 10% of rural children under five years of age were actually using zinc for childhood diarrhea. Use of zinc was shown to be safe, with few side-effects, and did not affect the use of traditional treatments for diarrhea. Researchers also found that many children were not given the correct ten-day course of treatment; 50% of parents were sold seven or fewer zinc tablets.
What Do These Findings Mean?
These findings show that the first national campaign promoting zinc treatment for childhood diarrhea in Bangladesh has had some success. Addition of zinc tablets for diarrhea treatment did not interfere with existing therapies. Mass media campaigns, using TV and radio, were useful for promoting health care initiatives nationwide alongside the education of health care providers and care-givers. The study also identified areas where more work is needed. Surveys in more remote, hard to reach sites in Bangladesh would provide better representation of the country as a whole. High awareness of zinc did not translate into high use. Repeated surveying in the same subdistricts may have overestimated actual awareness levels. Furthermore, mass media messages must link with messages from health care providers to help to reinforce and promote understanding of the use of zinc. A change in focus of media messages from awareness to promoting household decision-making may aid the adoption of zinc treatment for childhood diarrhea and improve adherence.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000175
The International Centre for Diarrhoeal Disease Research, Bangladesh Web site has information about the study
The World Health Organisation provides information on diarrhea
The study was sponsored by the Bill & Melinda Gates Foundation
doi:10.1371/journal.pmed.1000175
PMCID: PMC2765636  PMID: 19888335
14.  Effect of Household-Based Drinking Water Chlorination on Diarrhoea among Children under Five in Orissa, India: A Double-Blind Randomised Placebo-Controlled Trial 
PLoS Medicine  2013;10(8):e1001497.
Sophie Boisson and colleagues conducted a double-blind, randomized placebo-controlled trial in Orissa, a state in southeast India, to evaluate the effect of household water treatment in preventing diarrheal illnesses in children aged under five years of age.
Please see later in the article for the Editors' Summary
Background
Boiling, disinfecting, and filtering water within the home can improve the microbiological quality of drinking water among the hundreds of millions of people who rely on unsafe water supplies. However, the impact of these interventions on diarrhoea is unclear. Most studies using open trial designs have reported a protective effect on diarrhoea while blinded studies of household water treatment in low-income settings have found no such effect. However, none of those studies were powered to detect an impact among children under five and participants were followed-up over short periods of time. The aim of this study was to measure the effect of in-home water disinfection on diarrhoea among children under five.
Methods and Findings
We conducted a double-blind randomised controlled trial between November 2010 and December 2011. The study included 2,163 households and 2,986 children under five in rural and urban communities of Orissa, India. The intervention consisted of an intensive promotion campaign and free distribution of sodium dichloroisocyanurate (NaDCC) tablets during bi-monthly households visits. An independent evaluation team visited households monthly for one year to collect health data and water samples. The primary outcome was the longitudinal prevalence of diarrhoea (3-day point prevalence) among children aged under five. Weight-for-age was also measured at each visit to assess its potential as a proxy marker for diarrhoea. Adherence was monitored each month through caregiver's reports and the presence of residual free chlorine in the child's drinking water at the time of visit. On 20% of the total household visits, children's drinking water was assayed for thermotolerant coliforms (TTC), an indicator of faecal contamination. The primary analysis was on an intention-to-treat basis. Binomial regression with a log link function and robust standard errors was used to compare prevalence of diarrhoea between arms. We used generalised estimating equations to account for clustering at the household level. The impact of the intervention on weight-for-age z scores (WAZ) was analysed using random effect linear regression.
Over the follow-up period, 84,391 child-days of observations were recorded, representing 88% of total possible child-days of observation. The longitudinal prevalence of diarrhoea among intervention children was 1.69% compared to 1.74% among controls. After adjusting for clustering within household, the prevalence ratio of the intervention to control was 0.95 (95% CI 0.79–1.13). The mean WAZ was similar among children of the intervention and control groups (−1.586 versus −1.589, respectively). Among intervention households, 51% reported their child's drinking water to be treated with the tablets at the time of visit, though only 32% of water samples tested positive for residual chlorine. Faecal contamination of drinking water was lower among intervention households than controls (geometric mean TTC count of 50 [95% CI 44–57] per 100 ml compared to 122 [95% CI 107–139] per 100 ml among controls [p<0.001] [n = 4,546]).
Conclusions
Our study was designed to overcome the shortcomings of previous double-blinded trials of household water treatment in low-income settings. The sample size was larger, the follow-up period longer, both urban and rural populations were included, and adherence and water quality were monitored extensively over time. These results provide no evidence that the intervention was protective against diarrhoea. Low compliance and modest reduction in water contamination may have contributed to the lack of effect. However, our findings are consistent with other blinded studies of similar interventions and raise additional questions about the actual health impact of household water treatment under these conditions.
Trial Registration
ClinicalTrials.gov NCT01202383
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Millennium Development Goal 7 calls for halving the proportion of the global population without sustainable access to safe drinking water between 1990 and 2015. Although this target was met in 2010, according to latest figures, 768 million people world-wide still rely on unimproved drinking water sources. Access to clean drinking water is integral to good health and a key strategy in reducing diarrhoeal illness: Currently, 1.3 million children aged less than five years die of diarrhoeal illnesses every year with a sixth of such deaths occurring in one country—India. Although India has recently made substantial progress in improving water supplies throughout the country, currently almost 90% of the rural population does not have a water connection to their house and drinking water supplies throughout the country are extensively contaminated with human waste. A strategy internationally referred to as Household Water Treatment and Safe Storage (HWTS), which involves people boiling, chlorinating, and filtering water at home, has been recommended by the World Health Organization and UNICEF to improve water quality at the point of delivery.
Why Was This Study Done?
The WHO and UNICEF strategy to promote HWTS is based on previous studies from low-income settings that found that such interventions could reduce diarrhoeal illnesses by between 30%–40%. However, these studies had several limitations including reporting bias, short follow up periods, and small sample sizes; and importantly, in blinded studies (in which both the study participants and researchers are unaware of which participants are receiving the intervention or the control) have found no evidence that HWTS is protective against diarrhoeal illnesses. So the researchers conducted a blinded study (a double-blind, randomized placebo-controlled trial) in Orissa, a state in southeast India, to address those shortcomings and evaluate the effect of household water treatment in preventing diarrhoeal illnesses in children under five years of age.
What Did the Researchers Do and Find?
The researchers conducted their study in 11 informal settlements (where the inhabitants do not benefit from public water or sewers) in the state's capital city and also in 20 rural villages. 2,163 households were randomized to receive the intervention—the promotion and free distribution of sodium dichloroisocyanurate (chlorine) disinfection tablets with instruction on how to use them—or placebo tablets that were similar in appearance and had the same effervescent base as the chlorine tablets. Trained field workers visited households every month for 12 months (between December 2010 and December 2011) to record whether any child had experienced diarrhoea in the previous three days (as reported by the primary care giver). The researchers tested compliance with the intervention by asking participants if they had treated the water and also by testing for chlorine in the water.
Using these methods, the researchers found that over the 12-month follow-up period, the longitudinal prevalence of diarrhoea among children in the intervention group was 1.69% compared to 1.74% in the control group, a non-significant finding (a finding that could have happened by chance). There was also no difference in diarrhoea prevalence among other household members in the two groups and no difference in weight for age z scores (a measurement of growth) between children in the two groups. The researchers also found that although just over half (51%) of households in the intervention group reported treating their water, on testing, only 32% of water samples tested positive for chlorine. Finally, the researchers found that water quality (as measured by thermotolerant coliforms, TTCs) was better in the intervention group than the control group.
What Do These Findings Mean?
These findings suggest that treating water with chlorine tablets has no effect in reducing the prevalence of diarrhoea in both children aged under five years and in other household members in Orissa, India. However, poor compliance was a major issue with only a third of households in the intervention group confirmed as treating their water with chlorine tablets. Furthermore, these findings are limited in that the prevalence of diarrhoea was lower than expected, which may have also reduced the power of detecting a potential effect of the intervention. Nevertheless, this study raises questions about the health impact of household water treatment and highlights the key challenge of poor compliance with public health interventions.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001497.
The website of the World Health Organization has a section dedicated to household water treatment and safe storage, including a network to promote the use of HWTS and a toolkit to measure HWTS
The Water Institute hosts the communications portal for the International Network on Household Water Treatment and Safe Storage
doi:10.1371/journal.pmed.1001497
PMCID: PMC3747993  PMID: 23976883
15.  Impact of NGO Training and Support Intervention on Diarrhoea Management Practices in a Rural Community of Bangladesh: An Uncontrolled, Single-Arm Trial 
PLoS ONE  2014;9(11):e112308.
Purpose/Objective
The evolving Non-Governmental Organization (NGO) sector in Bangladesh provides health services directly, however some NGOs indirectly provide services by working with unlicensed providers. The primary objective of this study was to examine the impact of NGO training of unlicensed providers on diarrhoea management and the scale up of zinc treatment in rural populations.
Methods
An uncontrolled, single-arm trial for a training and support intervention on diarrhoea outcomes was employed in a rural sub-district of Bangladesh during 2008. Two local NGOs and their catchment populations were chosen for the study. The intervention included training of unlicensed health care providers in the management of acute childhood diarrhoea, particularly emphasizing zinc treatment. In addition, community-based promotion of zinc treatment was carried out. Baseline and endline ecologic surveys were carried out in intervention and control villages to document changes in treatments received for diarrhoea in under-five children.
Results
Among surveyed household with an active or recent acute childhood diarrhoea episode, 69% sought help from a health provider. Among these, 62.8% visited an unlicensed private provider. At baseline, 23.9% vs. 22% of control and intervention group children with diarrhoea had received zinc of any type. At endline (6 months later) this had changed to 15.3% vs. 30.2%, respectively. The change in zinc coverage was significantly higher in the intervention villages (p<0.01). Adherence with giving zinc for 10 days or more was significantly higher in the intervention households (9.2% vs. 2.5%; p<0.01). Child's age, duration of diarrhoea, type of diarrhoea, parental year of schooling as well as oral rehydration solution (ORS) and antibiotic usage were significant predictors of zinc usage.
Conclusion
Training of unlicensed healthcare providers through NGOs increased zinc coverage in the diarrhoea management of under-five children in rural Bangladesh households.
Trial Registration
ClinicalTrials.gov NCT02143921
doi:10.1371/journal.pone.0112308
PMCID: PMC4232353  PMID: 25398082
16.  An oral preparation of Lactobacillus acidophilus for the treatment of uncomplicated acute watery diarrhoea in Vietnamese children: study protocol for a multicentre, randomised, placebo-controlled trial 
Trials  2013;14:27.
Background
Diarrhoeal disease is a major global health problem, particularly affecting children under the age of 5 years. Besides oral rehydration solution, probiotics are also commonly prescribed to children with acute watery diarrhoea in some settings. Results from randomised clinical trials (RCTs) in which investigators studied the effect of probiotics on diarrhoeal symptoms have largely shown a positive effect; yet, the overall quality of the data is limited. In Vietnam, probiotics are the most frequently prescribed treatment for children hospitalised with acute watery diarrhoea, but there is little justification for this treatment in this location. We have designed a RCT to test the hypothesis that an oral preparation of Lactobacillus acidophilus is superior to placebo in the treatment of acute watery diarrhoea in Vietnamese children.
Methods
This RCT was designed to study the effect of treatment with L. acidophilus (4 × 109 colony-forming units/day) for 5 days for acute watery diarrhoea against a placebo in 300 children ages 9 to 60 months admitted to hospitals in Vietnam. Clinical and laboratory data plus samples will be collected on admission, daily during hospitalisation, at discharge, and at follow-up visits for a subset of participants. The primary end point will be defined as the time from the first dose of study medication to the start of the first 24-hour period without diarrhoea as assessed by the on-duty nurse. Secondary endpoints include the time to cessation of diarrhoea as recorded by parents or guardians in an hourly checklist, stool frequency over the first 3 days, treatment failure, rotavirus and norovirus viral loads, and adverse events.
Discussion
The existing evidence for the use of probiotics in treating acute watery diarrhoea seems to favour their use. However, the size of the effect varies across publications. An array of different probiotic organisms, doses, treatment durations, study populations, designs, settings, and aetiologies have been described. In this trial, we will investigate whether probiotics are beneficial as an adjuvant treatment for children with acute watery diarrhoea in Vietnam, with the aim of guiding clinical practice through improved regional evidence.
Trial registration
Current Controlled Trials ISRCTN88101063
doi:10.1186/1745-6215-14-27
PMCID: PMC3563448  PMID: 23356823
Probiotics; Lactobacillus spp.; Diarrhoea; Randomised controlled trial; Rotavirus; Norovirus
17.  Improving community case management of diarrhoea and pneumonia in district Badin, Pakistan through a cluster randomised study—the NIGRAAN trial protocol 
Background
Diarrhoea and pneumonia contribute 30% of deaths in children under 5 in Pakistan. Pakistan’s Lady Health Workers Programme (LHW-P) covers about 60% of the population but has had little impact in reducing morbidity and mortality related to these major childhood killers. An external evaluation of the LHW-P suggests that lack of supportive supervision of LHWs by lady health supervisors (LHSs) is a key determinant of this problem. Project NIGRAAN aims to improve knowledge and skills of LHWs and community caregivers through supervisory strategies employed by LHSs. Ultimately, community case management (CCM) of childhood pneumonia and diarrhoea will improve.
Methods/Design
NIGRAAN is a cluster-randomised trial in District Badin, Pakistan. There are approximately 1100 LHWs supervised by 36 LHSs in Badin. For this study, each LHS serves as a cluster. All LHSs working permanently in Badin who regularly conduct and report field visits are eligible. Thirty-four LHSs have been allocated to either intervention or control arms in a ratio of 1:1 through computer-generated simple randomisation technique. Five LHWs from each LHSs are also randomly picked. All 34 LHSs and 170 LHWs will be actively monitored. The intervention consists of training to build LHS knowledge and skills, clinical mentorship and written feedback to LHWs. Pre- and post-intervention assessments of LHSs, LHWs and community caregivers will be conducted via focus group discussions, in-depth interviews, knowledge assessment questionnaires, skill assessment scorecards and household surveys.
Primary outcome is improvement in CCM practices of childhood diarrhoea and pneumonia and will be assessed at the cluster level.
Discussion
NIGRAAN takes a novel approach to implementation research and explores whether training of LHSs in supervisory skills results in improving the CCM practices of childhood diarrhoea and pneumonia. No significant harm to participants is anticipated. The enablers and barriers towards improved CCM would provide recommendations to policymakers for scale up of this intervention nationally and regionally.
Trial registration
NIGRAAN is registered with the ‘Australian New Zealand Clinical Trials Registry’. Registration Number: ACTRN12613001261707
doi:10.1186/s13012-014-0186-9
PMCID: PMC4297376  PMID: 25490971
Community case management; Pneumonia and diarrhoea; LHW programme; Supervision; Implementation research; Pakistan
18.  A Multifaceted Intervention to Implement Guidelines and Improve Admission Paediatric Care in Kenyan District Hospitals: A Cluster Randomised Trial 
PLoS Medicine  2011;8(4):e1001018.
Philip Ayieko and colleagues report the outcomes of a cluster-randomized trial carried out in eight Kenyan district hospitals evaluating the effects of a complex intervention involving improved training and supervision for clinicians. They found a higher performance of hospitals assigned to the complex intervention on a variety of process of care measures, as compared to those receiving the control intervention.
Background
In developing countries referral of severely ill children from primary care to district hospitals is common, but hospital care is often of poor quality. However, strategies to change multiple paediatric care practices in rural hospitals have rarely been evaluated.
Methods and Findings
This cluster randomized trial was conducted in eight rural Kenyan district hospitals, four of which were randomly assigned to a full intervention aimed at improving quality of clinical care (evidence-based guidelines, training, job aides, local facilitation, supervision, and face-to-face feedback; n = 4) and the remaining four to control intervention (guidelines, didactic training, job aides, and written feedback; n = 4). Prespecified structure, process, and outcome indicators were measured at baseline and during three and five 6-monthly surveys in control and intervention hospitals, respectively. Primary outcomes were process of care measures, assessed at 18 months postbaseline.
In both groups performance improved from baseline. Completion of admission assessment tasks was higher in intervention sites at 18 months (mean = 0.94 versus 0.65, adjusted difference 0.54 [95% confidence interval 0.05–0.29]). Uptake of guideline recommended therapeutic practices was also higher within intervention hospitals: adoption of once daily gentamicin (89.2% versus 74.4%; 17.1% [8.04%–26.1%]); loading dose quinine (91.9% versus 66.7%, 26.3% [−3.66% to 56.3%]); and adequate prescriptions of intravenous fluids for severe dehydration (67.2% versus 40.6%; 29.9% [10.9%–48.9%]). The proportion of children receiving inappropriate doses of drugs in intervention hospitals was lower (quinine dose >40 mg/kg/day; 1.0% versus 7.5%; −6.5% [−12.9% to 0.20%]), and inadequate gentamicin dose (2.2% versus 9.0%; −6.8% [−11.9% to −1.6%]).
Conclusions
Specific efforts are needed to improve hospital care in developing countries. A full, multifaceted intervention was associated with greater changes in practice spanning multiple, high mortality conditions in rural Kenyan hospitals than a partial intervention, providing one model for bridging the evidence to practice gap and improving admission care in similar settings.
Trial registration
Current Controlled Trials ISRCTN42996612
Please see later in the article for the Editors' Summary
Editors' Summary
Background
In 2008, nearly 10 million children died in early childhood. Nearly all these deaths were in low- and middle-income countries—half were in Africa. In Kenya, for example, 74 out every 1,000 children born died before they reached their fifth birthday. About half of all childhood (pediatric) deaths in developing countries are caused by pneumonia, diarrhea, and malaria. Deaths from these common diseases could be prevented if all sick children had access to quality health care in the community (“primary” health care provided by health centers, pharmacists, family doctors, and traditional healers) and in district hospitals (“secondary” health care). Unfortunately, primary health care facilities in developing countries often lack essential diagnostic capabilities and drugs, and pediatric hospital care is frequently inadequate with many deaths occurring soon after admission. Consequently, in 1996, as part of global efforts to reduce childhood illnesses and deaths, the World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) introduced the Integrated Management of Childhood Illnesses (IMCI) strategy. This approach to child health focuses on the well-being of the whole child and aims to improve the case management skills of health care staff at all levels, health systems, and family and community health practices.
Why Was This Study Done?
The implementation of IMCI has been evaluated at the primary health care level, but its implementation in district hospitals has not been evaluated. So, for example, interventions designed to encourage the routine use of WHO disease-specific guidelines in rural pediatric hospitals have not been tested. In this cluster randomized trial, the researchers develop and test a multifaceted intervention designed to improve the implementation of treatment guidelines and admission pediatric care in district hospitals in Kenya. In a cluster randomized trial, groups of patients rather than individual patients are randomly assigned to receive alternative interventions and the outcomes in different “clusters” of patients are compared. In this trial, each cluster is a district hospital.
What Did the Researchers Do and Find?
The researchers randomly assigned eight Kenyan district hospitals to the “full” or “control” intervention, interventions that differed in intensity but that both included more strategies to promote implementation of best practice than are usually applied in Kenyan rural hospitals. The full intervention included provision of clinical practice guidelines and training in their use, six-monthly survey-based hospital assessments followed by face-to-face feedback of survey findings, 5.5 days training for health care workers, provision of job aids such as structured pediatric admission records, external supervision, and the identification of a local facilitator to promote guideline use and to provide on-site problem solving. The control intervention included the provision of clinical practice guidelines (without training in their use) and job aids, six-monthly surveys with written feedback, and a 1.5-day lecture-based seminar to explain the guidelines. The researchers compared the implementation of various processes of care (activities of patients and doctors undertaken to ensure delivery of care) in the intervention and control hospitals at baseline and 18 months later. The performance of both groups of hospitals improved during the trial but more markedly in the intervention hospitals than in the control hospitals. At 18 months, the completion of admission assessment tasks and the uptake of guideline-recommended clinical practices were both higher in the intervention hospitals than in the control hospitals. Moreover, a lower proportion of children received inappropriate doses of drugs such as quinine for malaria in the intervention hospitals than in the control hospitals.
What Do These Findings Mean?
These findings show that specific efforts are needed to improve pediatric care in rural Kenya and suggest that interventions that include more approaches to changing clinical practice may be more effective than interventions that include fewer approaches. These findings are limited by certain aspects of the trial design, such as the small number of participating hospitals, and may not be generalizable to other hospitals in Kenya or to hospitals in other developing countries. Thus, although these findings seem to suggest that efforts to implement and scale up improved secondary pediatric health care will need to include more than the production and dissemination of printed materials, further research including trials or evaluation of test programs are necessary before widespread adoption of any multifaceted approach (which will need to be tailored to local conditions and available resources) can be contemplated.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001018.
WHO provides information on efforts to reduce global child mortality and on Integrated Management of Childhood Illness (IMCI); the WHO pocket book “Hospital care for children contains guidelines for the management of common illnesses with limited resources (available in several languages)
UNICEF also provides information on efforts to reduce child mortality and detailed statistics on child mortality
The iDOC Africa Web site, which is dedicated to improving the delivery of hospital care for children and newborns in Africa, provides links to the clinical guidelines and other resources used in this study
doi:10.1371/journal.pmed.1001018
PMCID: PMC3071366  PMID: 21483712
19.  National Scale-up of Zinc Promotion in Nepal: Results from a Post-project Population-based Survey 
The World Health Organization and the United Nations Children's Fund recommend using a new oral rehydration solution (ORS) plus zinc supplementation for 10-14 days for the treatment of diarrhoea in children aged less than five years. The Social Marketing Plus for Diarrhoeal Disease Control: Point of Use Water Disinfection and Zinc Treatment (POUZN) project in Nepal was one of the first zinc-promotion projects to move beyond pilot efforts into a scaled-up programme with national-level reach. This study used data from a survey conducted in 26 districts in Nepal in 2008 to examine zinc-use behaviour, knowledge, and beliefs of caregivers of children aged less than six years, other diarrhoea-treatment practices, and recollection of project communication messages. The results of the survey indicated that, by six months following the onset of a zinc-promotion campaign, the majority (67.5%) of children (n=289), aged less than six years, with diarrhoea were treated with ORS, and 15.4% were treated with zinc. Over half (53.1%) of all caregivers (n=3,550) interviewed had heard about zinc products; most (97.1%) of those who had heard of zinc knew that zinc should be used for the treatment of diarrhoea. Zinc-related knowledge and behaviours were positively associated with recall of communication messages. Children whose caregivers recalled the mass-media message that zinc should be used for 10 days [odds ratio (OR)=2.02, 95% confidence interval (CI) 1.85-2.19] and whose caregivers perceived that zinc is easy to obtain (OR=1.76, 95% CI 1.49-2.09) were more likely to be treated with zinc for 10 days, along with ORS. The findings demonstrated that mass media play an important role in increasing caregivers’ knowledge about zinc and encouraging trial and correct use. Future efforts should also focus on understanding the factors that motivate providers to continue recommending antibiotics and antidiarrhoeals instead of zinc. These findings are being used for informing the design and implementation of zinc programmes in other developing countries with a high prevalence of diarrhoea.
PMCID: PMC3131121  PMID: 21766556
Child health; Diarrhoea; Diarrhoea, Infantile; Knowledge, attitudes, and practices; Oral rehydration solutions; Oral rehydration therapy; Zinc; Nepal
20.  The role of community health workers in improving child health programmes in Mali 
Background
Mortality of children under the age of five remains one of the most important public health challenges in developing countries. In rural settings, the promotion of household and community health practices through community health workers (CHWs) is among the key strategies to improve child health. The objective of this study was to assess the performance of CHWs in the promotion of basic child heath services in rural Mali.
Methods
A community-based cross-sectional survey was undertaken using multi-stage cluster sampling of wards and villages. Data was collected through questionnaires among 401 child-caregivers and registers of 72 CHWs.
Results
Of 401 households suppose to receive a visit by a CHW, 219 (54.6%; confidence interval 95%; 49.6-59.5) had received at least one visit in the last three months before the survey. The mother is the most important caregiver (97%); high percentage being illiterate. Caregivers treat fever and diarrhoea with the correct regimen in 40% and 11% of cases respectively. Comparative analysis between households with and without CHW visits showed a positive influence of CHWs on family health practices: knowledge on the management of child fever (p = < 0.001), non-utilization of antibiotics in home treatment of diarrhoea (p = 0.003), presence of cloroquine in the household (p = 0.002), presence (p = 0.001) and use (p = < 0.001) of bed nets. A total of 27 (38%) CHWs had not received supervision at all, against 45 (63%) who have been followed regularly each month during the last six months.
Conclusion
Continuous training, transport means, adequate supervision and motivation of CHWs through the introduction of financial incentives and remuneration are among key factors to improve the work of CHWs in rural communities. Poor performance of basic household health practices can be related to irregular supply of drugs and the need of appropriate follow-up by CHWs.
doi:10.1186/1472-698X-9-28
PMCID: PMC2782322  PMID: 19903349
21.  Malaria treatment in the retail sector: Knowledge and practices of drug sellers in rural Tanzania 
BMC Public Health  2008;8:157.
Background
Throughout Africa, the private retail sector has been recognised as an important source of antimalarial treatment, complementing formal health services. However, the quality of advice and treatment at private outlets is a widespread concern, especially with the introduction of artemisinin-based combination therapies (ACTs). As a result, ACTs are often deployed exclusively through public health facilities, potentially leading to poorer access among parts of the population. This research aimed at assessing the performance of the retail sector in rural Tanzania. Such information is urgently required to improve and broaden delivery channels for life-saving drugs.
Methods
During a comprehensive shop census in the districts of Kilombero and Ulanga, Tanzania, we interviewed 489 shopkeepers about their knowledge of malaria and malaria treatment. A complementary mystery shoppers study was conducted in 118 retail outlets in order to assess the vendors' drug selling practices. Both studies included drug stores as well as general shops.
Results
Shopkeepers in drug stores were able to name more malaria symptoms and were more knowledgeable about malaria treatment than their peers in general shops. In drug stores, 52% mentioned the correct child-dosage of sulphadoxine-pyrimethamine (SP) compared to only 3% in general shops. In drug stores, mystery shoppers were more likely to receive an appropriate treatment (OR = 9.6), but at an approximately seven times higher price. Overall, adults were more often sold an antimalarial than children (OR = 11.3). On the other hand, general shopkeepers were often ready to refer especially children to a higher level if they felt unable to manage the case.
Conclusion
The quality of malaria case-management in the retail sector is not satisfactory. Drug stores should be supported and empowered to provide correct malaria-treatment with drugs they are allowed to dispense. At the same time, the role of general shops as first contact points for malaria patients needs to be re-considered. Interventions to improve availability of ACTs in the retail sector are urgently required within the given legal framework.
doi:10.1186/1471-2458-8-157
PMCID: PMC2405791  PMID: 18471299
22.  Introducing rapid diagnostic tests for malaria into drug shops in Uganda: design and implementation of a cluster randomized trial 
Trials  2014;15(1):303.
Background
An intervention was designed to introduce rapid diagnostics tests for malaria (mRDTs) into registered drug shops in Uganda to encourage rational and appropriate treatment of malaria with artemisinin-based combination therapy (ACT). We conducted participatory training of drug shop vendors and implemented supporting interventions to orientate local communities (patients) and the public sector (health facility staff and district officials) to the behavioral changes in diagnosis, treatment and referral being introduced in drug shops. The intervention was designed to be evaluated through a cluster randomized trial. In this paper, we present detailed design, implementation and evaluation experiences in order to help inform future studies of a complex nature.
Methods
Three preparatory studies (formative, baseline and willingness-to-pay) were conducted to explore perceptions on diagnosis and treatment of malaria at drug shops, and affordable prices for mRDTs and ACTs in order to inform the design of the intervention and implementation modalities. The intervention required careful design with the intention to be acceptable, sustainable and effective. Critical components of intervention were: community sensitization and creating awareness, training of drug shop vendors to diagnose malaria with mRDTs, treat and refer customers to formal health facilities, giving pre-referral rectal artesunate and improved record-keeping. The primary outcome was the proportion of patients receiving appropriately-targeted treatment with ACT, evaluated against microscopy on a research blood slide.
Results
Introducing mRDTs in drug shops may seem simple, but our experience of intervention design, conduct and evaluation showed this to be a complex process requiring multiple interventions and evaluation components drawing from a combination of epidemiological, social science and health economics methodologies. The trial was conducted in phases sequenced such that each benefited from the other.
Conclusions
The main challenges in designing this trial were maintaining a balance between a robust intervention to support effective behaviour change and introducing practices that would be sustainable in a real-life situation in tropical Africa; as well as achieving a detailed evaluation without inadvertently influencing prescribing behaviour.
Trial registration
NCT01194557 registered with ClinicalTrials.gov 2 September 2010.
doi:10.1186/1745-6215-15-303
PMCID: PMC4125706  PMID: 25069975
Malaria; Rapid diagnostic tests; ACT; Drug shops; Private sector; Pragmatic trial; Uganda
23.  Role of Antidiarrhoeal Drugs as Adjunctive Therapies for Acute Diarrhoea in Children 
Acute diarrhoea is a leading cause of child mortality in developing countries. Principal pathogens include Escherichia coli, rotaviruses, and noroviruses. 90% of diarrhoeal deaths are attributable to inadequate sanitation. Acute diarrhoea is the second leading cause of overall childhood mortality and accounts for 18% of deaths among children under five. In 2004 an estimated 1.5 million children died from diarrhoea, with 80% of deaths occurring before the age of two. Treatment goals are to prevent dehydration and nutritional damage and to reduce duration and severity of diarrhoeal episodes. The recommended therapeutic regimen is to provide oral rehydration solutions (ORS) and to continue feeding. Although ORS effectively mitigates dehydration, it has no effect on the duration, severity, or frequency of diarrhoeal episodes. Adjuvant therapy with micronutrients, probiotics, or antidiarrhoeal agents may thus be useful. The WHO recommends the use of zinc tablets in association with ORS. The ESPGHAN/ESPID treatment guidelines consider the use of racecadotril, diosmectite, or probiotics as possible adjunctive therapy to ORS. Only racecadotril and diosmectite reduce stool output, but no treatment has yet been shown to reduce hospitalisation rate or mortality. Appropriate management with validated treatments may help reduce the health and economic burden of acute diarrhoea in children worldwide.
doi:10.1155/2013/612403
PMCID: PMC3603675  PMID: 23533446
24.  Performance of a Community-based Health and Nutrition-education Intervention in the Management of Diarrhoea in a Slum of Delhi, India 
Diarrhoeal infections are the fifth leading cause of death worldwide and continue to take a high toll on child health. Mushrooming of slums due to continuous urbanization has made diarrhoea one of the biggest public-health challenges in metropolitan cities in India. The objective of the study was to carry out a community-based health and nutrition-education intervention, focusing on several factors influencing child health with special emphasis on diarrhoea, in a slum of Delhi, India. Mothers (n=370) of children, aged >12–71 months, identified by a door-to-door survey from a large urban slum, were enrolled in the study in two groups, i.e. control and intervention. To ensure minimal group interaction, enrollment for the control and intervention groups was done purposively from two extreme ends of the slum cluster. Baseline assessment of knowledge, attitudes, and practices on diarrhoea-related issues, such as oral rehydration therapy (ORT), oral rehydration salt (ORS), and continuation of breastfeeding during diarrhoea, was carried out using a pretested questionnaire. Thereafter, mothers (n=195) from the intervention area were provided health and nutrition education through fortnightly contacts achieved by two approaches developed for the study—‘personal discussion sessions’ and ‘lane approach’. The mothers (n=175) from the control area were not contacted. After the intervention, there was a significant (p=0.000) improvement in acquaintance to the term ‘ORS’ (65–98%), along with its method of reconstitution from packets (13–69%); preparation of home-made sugar-salt solution (10–74%); role of both in the prevention of dehydration (30–74%) and importance of their daily preparation (74–96%); and continuation of breastfeeding during diarrhoea (47–90%) in the intervention area. Sensitivity about age-specific feeding of ORS also improved significantly (p=0.000) from 13% to 88%. The reported usage of ORS packets and sugar-salt solution improved significantly from 12% to 65% (p=0.000) and 12% to 75% (p=0.005) respectively. The results showed that health and nutrition-education intervention improved the knowledge and attitudes of mothers. The results indicate a need for intensive programmes, especially directed towards urban slums to further improve the usage of oral rehydration therapy.
PMCID: PMC2995023  PMID: 21261200
Community health; Diarrhoea; Interventions; Nutrition education; Oral rehydration solutions; Slums; India
25.  Perspectives on child diarrhoea management and health service use among ethnic minority caregivers in Vietnam 
BMC Public Health  2011;11:690.
Background
In Vietnam, primary government health services are now accessible for the whole population including ethnic minority groups (EMGs) living in rural and mountainous areas. However, little is known about EMGs' own perspectives on illness treatment and use of health services. This study investigates treatment seeking strategies for child diarrhoea among ethnic minority caregivers in Northern Vietnam in order to suggest improvements to health services for EMGs and other vulnerable groups.
Methods
The study obtained qualitative data from eight months of field work among four EMGs in lowland and highland villages in the Northern Lao Cai province. Triangulation of methods included in-depth interviews with 43 caregivers of pre-school children (six years and below) who had a case of diarrhoea during the past month, three focus group discussions (FGDs) with men, and two weeks of observations at two Communal Health Stations (CHGs). Data was content-analyzed by ordering data into empirically and theoretically inspired themes and sub-categories assisted by the software NVivo8.
Results
This study identified several obstacles for EMG caregivers seeking health services, including: gender roles, long travelling distances for highland villagers, concerns about the indirect costs of treatment and a reluctance to use government health facilities due to feelings of being treated disrespectfully by health staff. However, ethnic minority caregivers all recognized the danger signs of child diarrhoea and actively sought simultaneous treatment in different health care systems and home-based care. Treatments were selected by matching the perceived cause and severity of the disease with the 'compatibility' of different treatments to the child.
Conclusions
In order to improve EMGs' use of government health services it is necessary to improve the communication skills of health staff and to acknowledge both EMGs' explanatory disease models and the significant socio-economic constraints they experience. Broader health promotion programs should address the significant gender roles preventing highland mothers from seeking health services and include family elders and fathers in future health promotion programs. Encouraging existing child health care practices, including continued breastfeeding during illness and the use of home-made rehydration solutions, also present important opportunities for future child health promotion.
doi:10.1186/1471-2458-11-690
PMCID: PMC3189136  PMID: 21896194

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