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Background: To address concerns about the quality of reporting of randomized controlled trials, and the potential for biased treatment effects in poorly reported trials, medical journals have adopted a common set of reporting guidelines, the Consolidated Standards of Reporting Trials (CONSORT) statement, to improve the reporting of randomized controlled trials.Hypothesis: The reporting of clinical trials involving dogs and cats might not be ideal, and this might be associated with biased treatment effects.Animals: Dogs and cats used in 100 randomly selected reports of clinical trials. Methods: Data related to methodological quality and completeness of reporting were extracted from each trial. Associations between reporting of trial features and the proportion of positive treatment effects within trials were evaluated by generalized linear models.Results: There were substantive deficiencies in reporting of key trial features. An increased proportion of positive treatment effects within a trial was associated with not reporting: the method used to generate the random allocation sequence (P o .001), the use of double blinding (P o .001), the inclusion criteria for study subjects (P 5 .003), baseline differences between treatment groups (P 5 .006), the measurement used for all outcomes (P 5 .002), and possible study limitations (P 5 .03).Conclusions and Clinical Importance: Many clinical trials involving dogs and cats in the literature do not report details related to methodological quality and aspects necessary to evaluate external validity. There is some evidence that these deficiencies are associated with treatment effects. There is a need to improve reporting of clinical trials, and guidelines, such as the CONSORT statement, can provide a valuable tool for meeting this need.

Randomized controlled trials (RCTs) are the gold standard for evaluating treatment efficacy. Therefore, it is important that RCTs are conducted with methodological rigor to prevent biased results and report results in a manner that allows the reader to evaluate internal and external validity. Most human health journals now require manuscripts to meet the Consolidated Standards of Reporting Trials (CONSORT) criteria for reporting of RCTs. Our objective was to evaluate preharvest food safety trials using a modification of the CONSORT criteria to assess methodological quality and completeness of reporting, and to investigate associations between reporting and treatment effects. One hundred randomly selected trials were evaluated using a modified CONSORT statement. The majority of the selected trials (84%) used a deliberate disease challenge, with the remainder representing natural pathogen exposure. There were widespread deficiencies in the reporting of many trial features. Randomization, double blinding, and the number of subjects lost to follow-up were reported in only 46%, 0%, and 43% of trials, respectively. The inclusion criteria for study subjects were only described in 16% of trials, and the number of animals housed together was only stated in 52% of the trials. Although 91 trials had more than one outcome, no trials specified the primary outcome of interest. There were significant bivariable associations between the proportion of positive treatment effects and failure to report the number of subjects lost to follow-up, the number of animals housed together in a group, the level of treatment allocation, and possible study limitations. The results suggest that there are substantive deficiencies in reporting of preharvest food safety trials, and that these deficiencies may be associated with biased treatment effects. The creation and adoption of standards for reporting in preharvest food safety trials will help to ensure the inclusion of important trial details in all publications.

OBJETIVOS: avaliar o impacto do uso da água de cisternas na ocorrência de episódios diarréicos comparando o número e a duração de episódios entre moradores de domicílios com e sem cisternas, numa mesma área geográfica. MÉTODOS: estudo longitudinal prospectivo aninhado a um estudo de corte transversal com dois grupos de comparação (domicílios com e sem cisternas) realizado, em 21 municípios do Agreste Central de Pernambuco, em 2007. O período de coleta foi de 60 dias, e incluiu 1765 indivíduos. Para análise descritiva utilizou-se modelos mistos hierárquicos, Mann-Whitney e Kaplan-Meyer com nível de significância de 5%. RESULTADOS: entre os 949 indivíduos com cisternas, obteve-se uma redução no risco de ocorrência de episódios diarréicos de 73% quando comparados aos 816 indivíduos sem cisternas (RR=0,27; p<0.001). O número médio de episódios registrados nos residentes de domicílios sem cisternas foi de 0,48 (DP=1,17), contra 0,08 (DP=0,32) nos domicílios com cisternas(z=-10,26; p<0,001). A duração média dos episódios foi 1,5 vezes maior nos domicílios sem cisternas (χ²=8,99; p=0,003). CONCLUSÕES: os achados deste estudo destacam a importância do acesso à água potável na redução de doenças. A ocorrência de diarréia, bem como, seus indicadores de gravidade - número de episódios e duração da diarréia foram consistentemente maiores nos residentes de domicílios sem cisternas.

BackgroundLack of access to safe and secure water is an international issue recognized by the United Nations. To address this problem, the One Million Cisterns Project was initiated in 2001 in Brazil’s semi-arid region to provide a sustainable source of water to households. The objectives of this study were to determine the 30-day period prevalence of diarrhoea in individuals with and without cisterns and determine symptomology, duration of illness and type of health care sought among those with diarrhoea. A subgroup analysis was also conducted among children less than five years old.MethodsA face-to-face survey was conducted between August 20th and September 20th, 2007 in the Agreste Central Region of Pernambuco State, Brazil. Households with and without a cistern that had at least one child under the age of five years were selected using systematic convenient sampling. Differences in health outcomes between groups were assessed using Pearson’s Chi-squared and two-way t-tests. Demographic variables were tested for univariable associations with diarrhoea using logistic regression with random effects. P-values of 0.05 or less were considered statistically significant.ResultsA total of 3679 people from 774 households were included in the analysis (1863 people from 377 households with cisterns and 1816 people from 397 households without cisterns). People from households with a cistern had a significantly lower 30-day period prevalence of diarrhoea (prevalence = 11.0%; 95% CI 9.5-12.4) than people from households without a cistern (prevalence = 18.2%; 95% CI 16.4-20.0). This significant difference was also found in a subgroup analysis of children under five years old; those children with a cistern had a 30-day period prevalence of 15.6% (95% CI 12.3-18.9) versus 26.7% (95% CI 22.8-30.6) in children without a cistern. There were no significant differences between those people with and without cisterns in terms of the types of symptoms, duration of illness and health care sought for diarrhoea.ConclusionsOur results indicate that the use of cisterns for drinking water is associated with a decreased occurrence of diarrhoea in this study population. Further research accounting for additional risk factors and preventative factors should be conducted.