Detecting the extent of control over selection bias relating to oral health and otorhinolaryngology: cross-sectional study

ABSTRACT BACKGROUND: The authors of randomized controlled trials will usually claim that they have met the randomization process criterion. However, sequence generation schemes differ and some schemes that are claimed to be randomized are not genuinely randomized. Even less well understood, and often more difficult to ascertain, is whether the allocation was really concealed. OBJECTIVE: To detect the extent of control over selection bias, in a comparison between two Cochrane groups: oral health and otorhinolaryngology; and to describe the methods used to control for this bias. DESIGN AND SETTING: Cross-sectional study conducted in a public university in São Paulo, Brazil. METHODS: The risk of selection bias in 1,714 records indexed in Medline database up to 2018 was assessed, independent of language and access. Two dimensions implicated in the allocation were considered: generation of the allocation sequence; and allocation concealment. RESULTS: We included 420 randomized controlled trials and all of them were evaluated to detect selection bias. In the sample studied, only 28 properly controlled the selection bias. Lack of control over selection bias was present in 80% of the studies evaluated in both groups. CONCLUSION: The two groups were similar regarding control over selection bias. They are also similar to the methods used. The dimension of allocation concealment appears to be a limiting factor with regard to production of randomized controlled trials with low risk of selection bias. The quality of reporting in studies on oral health and otorhinolaryngology is suboptimal and needs to be improved, in line with other fields of healthcare.

Lateral wedge insole for knee osteoarthritis: randomized clinical trial / Palmilha valgizante para osteoartrite de joelhos: ensaio clínico randomizado

CONTEXT AND OBJECTIVE: Optimal management of knee osteoarthritis requires a combination of pharmacological and non-pharmacological methods. The use of lateral wedge insoles to treat medial knee osteoarthritis is recommended, but there is still controversy about its efficacy. The purpose of this study was to ascertain whether the use of lateral wedge insoles can diminish pain and improve function in patients with medial knee osteoarthritis. DESIGN AND SETTING: Prospective randomized trial conducted in a tertiary-level hospital. METHODS: We prospectively enrolled 58 patients with medial knee osteoarthritis and randomized them to use either a lateral wedge insole with subtalar strapping (Group W), or a neutral insole with subtalar strapping (Group N - control). All the patients were instructed to use the insole for five to ten hours per day. A visual analogue pain scale, the Western Ontario and McMaster Universities Arthritis Index (WOMAC) and the Lequesne questionnaire were applied at baseline and at weeks 2, 8 and 24. RESULTS: At weeks 8 and 24, both groups showed lower scores for WOMAC (P = 0,023 and P = 0,012 respectively). There were no statistically significant differences between the groups regarding the visual analogue pain scale, WOMAC or Lequesne results at any time evaluated. CONCLUSION: The use of a lateral wedge insole with subtalar strapping improved the patients' symptoms and function but was not superior ...

CONTEXTO E OBJETIVO: O manejo ideal da osteoartrite de joelhos requer combinação entre modalidades farmacológicas e não farmacológicas. O uso de palmilhas valgizantes no tratamento da osteoartrite medial do joelho é recomendado, mas sua eficácia ainda é controversa. Este estudo objetiva verificar se o uso da palmilha valgizante pode diminuir a dor e melhorar a função dos pacientes com osteoartrite medial dos joelhos. DESENHO E LOCAL: Ensaio clínico prospectivo e randomizado conduzido em hospital de atenção terciária. MÉTODOS: Alocamos prospectivamente 58 pacientes com osteoartrite medial dos joelhos que foram randomizados para fazer uso de palmilha valgizante com amarrilho subtalar (Grupo W) ou palmilha neutra com amarrilho subtalar (Grupo N - controle). Todos os pacientes foram orientados a utilizar a palmilha entre cinco e dez horas por dia. Foram aplicados os questionários Western Ontario and McMaster Universities Arthritis Index (WOMAC) e Lequesne, além da escala visual analógica da dor, nos momentos pré e após 2, 8 e 24 semanas. RESULTADOS: Após 8 e 24 semanas, ambos os grupos apresentaram redução dos valores de WOMAC (P = 0,023 e P = 0,012 respectivamente). Não houve diferença estatisticamente significativa entre os grupos nos resultados de WOMAC, Lequesne e escala visual analógica de dor, em nenhum dos momentos avaliados. ...

Assessing the risk of bias in randomized controlled trials in the field of dentistry indexed in the Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde) database / Avaliação do risco de viés de ensaios controlados randomizados de odontologia indexados na base de dados Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde)

CONTEXT AND OBJECTIVE: Well-conducted randomized controlled trials (RCTs) represent the highest level of evidence when the research question relates to the effect of therapeutic or preventive interventions. However, the degree of control over bias between RCTs presents great variability between studies. For this reason, with the increasing interest in and production of systematic reviews and meta-analyses, it has been necessary to develop methodology supported by empirical evidence, so as to encourage and enhance the production of valid RCTs with low risk of bias. The aim here was to conduct a methodological analysis within the field of dentistry, regarding the risk of bias in open-access RCTs available in the Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde) database. DESIGN AND SETTING: This was a methodology study conducted at Universidade Federal de São Paulo (Unifesp) that assessed the risk of bias in RCTs, using the following dimensions: allocation sequence generation, allocation concealment, blinding, and data on incomplete outcomes. RESULTS: Out of the 4,503 articles classified, only 10 studies (0.22 percent) were considered to be true RCTs and, of these, only a single study was classified as presenting low risk of bias. The items that the authors of these RCTs most frequently controlled for were blinding and data on incomplete outcomes. CONCLUSION: The effective presence of bias seriously weakened the reliability of the results from the dental studies evaluated, such that they would be of little use for clinicians and administrators as support for decision-making processes.

CONTEXTO E OBJETIVO: Ensaios controlados randomizados (ECRs) bem conduzidos representam o mais alto nível de evidência quando a pergunta de pesquisa é sobre o efeito de intervenções terapêuticas ou preventivas. No entanto, o grau de controle de viés entre os ECRs apresenta grande variabilidade entre estudos. Por esta razão, com o aumento do interesse e produção das revisões sistemáticas e metanálises, foi necessário desenvolver metodologia suportada por evidência empírica, para incentivar e valorizar a produção de ECRs válidos e com baixo risco de viés. O objetivo deste trabalho foi realizar uma análise metodológica da área de odontologia quanto ao risco de viés de ECRs de acesso aberto, disponibilizados no banco de dados do Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde). TIPO DE ESTUDO E LOCAL: Trata-se de um estudo sobre metodologia conduzido na Universidade Federal de São Paulo (Unifesp) que avaliou o risco de viés dos ECRs, utilizando as seguintes dimensões: geração da sequência de alocação, sigilo da alocação, cegamento e dados sobre desfechos incompletos. RESULTADOS: Dos 4.503 artigos classificados somente 10 (0,22 por cento) estudos foram considerados verdadeiros ECR e, destes, somente um estudo foi classificado como sendo de baixo risco de viés. Os itens mais frequentemente controlados pelos autores dos ECR foram cegamento e dados sobre desfechos incompletos. CONCLUSÃO: A presença efetiva de viés enfraqueceu seriamente a confiança nos resultados dos estudos de odontologia avaliados, sendo pouco úteis para clínicos e gestores como suporte a processos de decisão.

Influence of bromopride in the prophylaxis of nausea associated with fluorescein angiography

PURPOSES: To determine the efficacy of bromopride in the prophylaxis of nausea during fluorescein angiography, when compared with a placebo. METHODS: The study was a double-masked random clinical trial, between December of 2004 and April of 2005. Examinations were performed with 20 percent intravenous fluorescein sodium in a single dose of 2.5 ml. The patients were divided into two groups: group 1, patients who received a 2 ml intravenous dose of 5 mg/ml bromopride and group 2, patients who received a 2 ml intravenous dose of 0.9 percent sodium chloride (placebo), both 20 minutes before the dye injection. Cases of nausea were observed during and after the examination. RESULTS: 352 patients were enrolled, 176 in each group. Cases of nausea were observed in 12 (6.8 percent) patients of the bromopride group and in 11 (6.3 percent) patients of the placebo group (p<0.829 - relative risk=1.05). CONCLUSION: Bromopride did not prevent the occurrence of nausea in fluorescein angiography, when compared with a placebo.

OBJETIVOS: Determinar a eficiência da bromoprida na profilaxia de náuseas na angiofluoresceinografia, quando comparada a um placebo. MÉTODOS: O estudo foi um ensaio clínico aleatório duplo-mascarado, entre dezembro de 2004 e abril de 2005. Os exames foram realizados com fluoresceína sódica a 20 por cento intravenosa em dose única de 2,5 ml. Os pacientes foram divididos em dois grupos: grupo 1, pacientes que receberam 10 mg/ 2 ml de bromoprida via intravenosa e o grupo 2, pacientes que receberam uma dose 2 ml de cloreto de sódio a 0,9 por cento (placebo), ambos 20 minutos antes da injeção do contraste. Foram registrados os casos de náusea durante e após o exame. RESULTADOS: Foram selecionados 352 pacientes, 176 em cada grupo. Foram registrados casos de náusea em 12 (6,8 por cento) pacientes do grupo da bromoprida e 11 (6,3 por cento) pacientes do grupo placebo (p<0,829 - risco relativo=1,09). CONCLUSÃO: Neste estudo a bromoprida não preveniu a ocorrência de náuseas na angiofluoresceinografia, quando comparada a um placebo.