***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Abstract Objective To compare the effect on prevalence of diarrhoea and mortality of household based treatment of drinking water with flocculant-disinfectant , sodium hypochlorite , and st and ard practice s in areas with turbid water source in Africa . Design Cluster r and omised controlled trial over 20 weeks . Setting Family compounds , each containing several houses , in rural western Kenya . Participants 6650 people in 605 family compounds . Intervention Water treatment : flocculant-disinfectant , sodium hypochlorite , and usual practice ( control ) . Main outcome measures Prevalence of diarrhoea and all cause mortality . Escherichia coli concentration , free residual chlorine concentration , and turbidity in household drinking water as surrogates for effectiveness of water treatment . Results In children < 2 years old , compared with those in the control compounds , the absolute difference in prevalence of diarrhoea was –25 % in the flocculant-disinfectant arm ( 95 % confidence interval –40 to –5 ) and –17 % in the sodium hypochlorite arm ( –34 to 4 ) . In all age groups compared with control , the absolute difference in prevalence was –19 % in the flocculant-disinfectant arm ( –34 to –2 ) and –26 % in the sodium hypochlorite arm ( –39 to –9 ) . There were significantly fewer deaths in the intervention compounds than in the control compounds ( relative risk of death 0.58 , P = 0.036 ) . Fourteen per cent of water sample s from control compounds had E coli concentrations < 1 CFU/100 ml compared with 82 % in flocculant-disinfectant and 78 % in sodium hypochlorite compounds . The mean turbidity of drinking water was 8 nephelometric turbidity units ( NTU ) in flocculant-disinfectant households , compared with 55 NTU in the two other compounds ( P < 0.001 ) . Conclusions In areas of turbid water , flocculant-disinfectant was associated with a significant reduction in  diarrhoea among children < 2 years . This health benefit , combined with a significant reduction in turbidity , suggests that the flocculant-disinfectant is well suited to areas with highly contaminated and turbid water Reports of cluster r and omised trials require additional information to allow readers to interpret them accurately The effective reporting of r and omised controlled trials has received useful attention in recent years . Many journals now require that reports conform to the guidelines in the Consoli date d St and ards of Reporting Trials ( CONSORT ) statement , first published in 1996 and revised in 2001 . The statement includes a checklist of items that should be included in the trial report . These items are evidence based whenever possible and are regularly review ed . The statement also recommends including a flow diagram to show the flow of participants from group assignment through to the final analysis . The CONSORT statement focused on reporting parallel group r and omised trials in which individual participants are r and omly assigned to study groups . However , in some situations it is preferable to r and omly assign groups of individuals ( such as families or medical practice s ) rather than individuals . Reasons include the threat of contamination of some interventions ( such as dietary interventions ) if individual r and omisation is used . 5 Also , in certain setting s r and omisation by group may be the only feasible method of conducting a trial . Trials with this design are variously known as field trials , community based trials , place based trials , or ( as in this paper ) cluster r and omised trials . In an earlier discussion paper we considered the implication s of the CONSORT statement for the reporting of cluster r and omised trials . Here we present up date d guidance , based on the 2001 revision of the CONSORT statement Background Improving the health of school-aged children can yield substantial benefits for cognitive development and educational achievement . However , there is limited experimental evidence on the benefits of school-based malaria prevention or how health interventions interact with other efforts to improve education quality . This study aims to evaluate the impact of school-based malaria prevention and enhanced literacy instruction on the health and educational achievement of school children in Kenya . Design A factorial , cluster r and omised trial is being implemented in 101 government primary schools on the coast of Kenya . The interventions are ( i ) intermittent screening and treatment of malaria in schools by public health workers and ( ii ) training workshops and support for teachers to promote explicit and systematic literacy instruction . Schools are r and omised to one of four groups : receiving either ( i ) the malaria intervention alone ; ( ii ) the literacy intervention alone ; ( iii ) both interventions combined ; or ( iv ) control group where neither intervention is implemented . Children from classes 1 and 5 are r and omly selected and followed up for 24 months . The primary outcomes are educational achievement and anaemia , the hypothesised mediating variables through which education is affected . Secondary outcomes include malaria parasitaemia , school attendance and school performance . A nested process evaluation , using semi-structured interviews , focus group discussion and a stakeholder analysis will investigate the community acceptability , feasibility and cost-effectiveness of the interventions . Discussion Across Africa , governments are committed to improve health and education of school-aged children , but seek clear policy and technical guidance as to the optimal approach to address malaria and improved literacy . This evaluation will be one of the first to simultaneously evaluate the impact of health and education interventions in the improvement of educational achievement . Reflection is made on the practical issues encountered in conducting research in schools in Africa . Trial Registration National Institutes of Health Abstract The cluster r and omized trial ( CRT ) is used increasingly in knowledge translation research , quality improvement research , community based intervention studies , public health research , and research in developing countries . However , cluster trials raise difficult ethical issues that challenge research ers , research ethics committees , regulators , and sponsors as they seek to fulfill responsibly their respective roles . Our project will provide a systematic analysis of the ethics of cluster trials . Here we have outlined a series of six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation:1.Who is a research subject?2.From whom , how , and when must informed consent be obtained?3.Does clinical equipoise apply to CRTs?4.How do we determine if the benefits outweigh the risks of CRTs?5.How ought vulnerable groups be protected in CRTs?6.Who are gatekeepers and what are their responsibilities ? Subsequent papers in this series will address each of these areas , clarifying the ethical issues at stake and , where possible , arguing for a preferred solution . Our hope is that these papers will serve as the basis for the creation of international ethical guidelines for the design and conduct of cluster r and omized trials A group-r and omized controlled trial of insecticide (permethrin)-treated bed nets ( ITNs ) was conducted in an area of high perennial malaria transmission in western Kenya to test the effect of ITNs on  all-cause mortality in children 1 - 59 months of age . Child deaths were monitored over a two-year period by biannual household census in Asembo ( 1997 - 1998 ) and in Gem ( 1998 - 1999 ) . Overall , 1,722 deaths occurred in children 1 - 59 months followed for 35,932 child-years .  Crude mortality rates/1,000  child-years were 51.9 versus 43.9 in control and ITN villages in children 1 - 59 months old . The protective efficacy ( PE ) ( 95 % confidence interval ) adjusted for age , study year , study site , and season was 16 % ( 6 - 25 % ) . Corresponding figures in 1 - 11- and 12 - 59-month-old children in control and ITN villages were 133.3 versus 102.3 , PE = 23 % ( 11 - 34 % ) and 31.1 versus 28.7 , PE = 7 % ( -6 - 19 % ) . The numbers of lives saved/1,000 child-years were 8 , 31 , and 2 for the groups 1 - 59 , 1 - 11 , and 12 - 59 months old , respectively . Stratified analysis by time to insecticide re-treatment showed that the PE of  ITNs  re-treated per study protocol ( every six months ) was 20 % ( 10 - 29 % ) , overall and 26 % ( 12 - 37 % ) and 14 % ( -1 - 26 % ) in 1 - 11- and 12 - 59-month-old children , respectively . ITNs prevent approximately one in four infant deaths in areas of intense perennial malaria transmission , but their efficacy is compromised if re-treatment is delayed beyond six months Background There are few reports of interventions to reduce the common but irrational use of antibiotics for acute non-bloody diarrhoea amongst hospitalised children in low-income setting s. We undertook a secondary analysis of data from an intervention comprising training of health workers , facilitation , supervision and face-to-face feedback , to assess whether it reduced inappropriate use of antibiotics in children with non-bloody diarrhoea and no co-morbidities requiring antibiotics , compared to a partial intervention comprising didactic training and written feedback only . This outcome was not a pre-specified end-point of the main trial . Methods Repeated cross-sectional survey data from a cluster-r and omised controlled trial of an intervention to improve management of common childhood illnesses in Kenya were used to describe the prevalence of inappropriate antibiotic use in a 7-day period in children aged 2 - 59 months with acute non-bloody diarrhoea . Logistic regression models with r and om effects for hospital were then used to identify patient and clinician level factors associated with inappropriate antibiotic use and to assess the effect of the intervention . Results 9 , 459 admission records of children were review ed for this outcome . Of these , 4 , 232 ( 44.7 % ) were diagnosed with diarrhoea , with 130 of these being bloody ( dysentery ) therefore requiring antibiotics . 1 , 160 children had non-bloody diarrhoea and no co-morbidities requiring antibiotics-these were the focus of the analysis . 750 ( 64.7 % ) of them received antibiotics inappropriately , 313 of these being in the intervention hospitals vs. 437 in the controls . The adjusted logistic regression model showed the baseline-adjusted odds of inappropriate antibiotic prescription to children admitted to the intervention hospitals was 0.30 times that in the control hospitals ( 95%CI 0.09 - 1.02 ) . Conclusion We found some evidence that the multi-faceted , sustained intervention described in this paper led to a reduction in the inappropriate use of antibiotics in treating children with non-bloody diarrhoea . Trial registration International St and ard R and omised Controlled Trial Number Register IS RCT A recent meta- analysis of 14 clinical trials indicated that daily compared with intermittent iron supplementation result ed in significantly greater hematological improvement in pregnant women . No such definitive beneficial effect was demonstrated in preschool children . We compared the efficacy of daily and twice weekly iron supplementation for 6 wk under supervised and unsupervised conditions in the treatment of mild and moderate anemia [ hemoglobin ( Hb ) 50 - 109 g/L ] in children aged 2 - 59 mo living in a malaria-endemic area of western Kenya . The study was a cluster-r and omized trial using a factorial design ; participants were aware of the treatment assigned . All children ( n = 1049 ) were administered a single dose of sulfadoxine-pyrimethamine at enrollment followed by 6 wk of daily supervised iron supplementation [ 3 - 6 mg/(kg.d ) ] , twice weekly supervised iron supplementation [ 6 - 12 mg/(kg.wk ) ] , daily unsupervised iron supplementation , or twice weekly unsupervised iron supplementation . In the supervised groups , Hb concentrations at 6 and 12 wk ( 6 wk postsupplementation ) were significantly higher in children given iron daily rather than twice weekly [ mean ( 95 % CI ) difference at 6-wk : 4.2 g/L ( 2.1 , 6.4 ) ; 12-wk : 4.4 g/L ( 1.8 , 7.0 ) ] . Among the unsupervised groups , Hb concentrations were not different at 6 wk [ mean ( 95 % CI ) difference : 0.86 g/L ( -1.4 , 3.1 ) ] , but significantly higher at 12 wk for those assigned daily iron [ mean ( 95 % CI ) difference : 3.4 g/L ( 0.79 , 6.0 ) , P = 0.02 ] . In this malarious area and after initial antimalarial treatment , 6 wk of daily iron supplementation results in better hematological responses than twice weekly iron supplementation in the treatment of anemia in preschool children , regardless of whether adherence can be ensured OBJECTIVE To examine changes in energy intake along with markers of dietary quality ( animal- source energy and protein intakes ) among household members in the presence of  supplementary school feeding in rural Kenya . DESIGN A 2-year , longitudinal , r and omized controlled feeding intervention study . SETTING Kyeni South Division , Embu District , Kenya . SUBJECTS A total of 182 schoolchildren and selected household members . RESULTS There was no evidence that schoolchildren who received supplementary snacks at school experienced reduced intakes at home or that intakes by other family members were increased at the expense of the schoolchild 's intake . CONCLUSIONS This analysis highlights a 
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The applicants challenged a government decision to offer  Nevirapine in a few pilot sites when evidence showed Nevirapine significantly reduced HIV transmission rates and despite donor offers of a free supply .