Reporting of core outcomes in gastric cancer surgery trials over the past 25 years (systematic review).

BACKGROUND: Gastric cancer, a leading cause of cancer-related mortality worldwide, has seen limited improvement in survival over the past 3 decades. Surgical resection is the cornerstone of curative management but the optimal approach remains unclear. Decision-making is hindered by inconsistent outcome reporting limiting data synthesis between trials. International consensus between healthcare professionals and patients has formed a core outcome set to be reported as a minimum. We appraised outcomes previously reported. METHODS: Evidence Based Medicine Reviews, MEDLINE, EMBASE and CINAHL were searched for randomised controlled trials (RCTs) and systematic reviews of RCTs during years 1995-2021. We searched trial registries for protocols of ongoing and future trials. RESULTS: Ninety-nine articles from 64 studies and 69 trial protocols were included. No study reported all core outcomes: average reported per trial was 4 (interquartile range: 2). 'Serious' adverse events were reported by 98%, completeness of tumour removal by 85% and surgery-related death by 74%. Outcomes important to patients were reported least: quality of life (22%) and nutritional effects (15%). Defining outcomes and time frames used was variable. CONCLUSIONS: Critically important outcomes are poorly reported in the literature and the status has not improved in future trials. Further work is required to improve uptake.

Improving mental health in chronic care in general practice: study protocol for a cluster-randomised controlled trial of the Healthy Mind intervention.

BACKGROUND: Mental health issues are common among patients with chronic physical conditions, affecting approximately one in five patients. Poor mental health is associated with worse disease outcomes and increased mortality. Problem-solving therapy (PST) may be a suitable treatment for targeting poor mental health in these patients. This study protocol describes a randomised controlled trial of the Healthy Mind intervention, a general practice-based intervention offering PST to patients with type 2 diabetes and/or ischaemic heart disease and poor mental well-being. METHODS: A stepped-wedge cluster-randomised controlled trial with 1-year follow-up will be conducted in Danish general practice. At the annual chronic care consultation, patients with type 2 diabetes and/or chronic ischaemic heart disease will be screened for poor mental well-being. Patients in the control group will be offered usual care while patients in the intervention group will be offered treatment with PST provided by general practitioners (GPs) or general practice staff, such as nurses, who will undergo a 2-day PST course before transitioning from the control to the intervention group. The primary outcome is change in depressive symptoms after 6 and 12 months. Secondary outcomes include change in mental well-being, anxiety, and diabetes distress (patients with type 2 diabetes) after 6 and 12 months as well as change in total cholesterol levels, low-density lipoprotein (LDL) levels, and blood glucose levels (patients with diabetes) after 12 months. Process outcomes include measures of implementation and mechanisms of impact. We aim to include a total of 188 patients, corresponding to approximately 14 average-sized general practices. DISCUSSION: The Healthy Mind trial investigates the impact of PST treatment for patients with chronic disease and poor mental well-being in general practice. This will be the first randomised controlled trial determining the effect of PST treatment for patients with chronic diseases in general practice. The results of this study will provide relevant insights to aid GPs, and general practice staff manage patients with poor mental well-being. TRIAL REGISTRATION: ClinicalTrials.gov NCT05611112. Registered on October 28, 2022.

Peripartum interventions for people with class III obesity: a systematic review and meta-analysis.

OBJECTIVE: This study aimed to identify evidence-based peripartum interventions for people with a body mass index ≥40 kg/m2. DATA SOURCES: PubMed, MEDLINE, EMBASE, Cochrane, CINAHL, and ClinicalTrials.gov were searched from inception to 2022 without date, publication type, or language restrictions. STUDY ELIGIBILITY CRITERIA: Cohort and randomized controlled trials that implemented an intervention and evaluated peripartum outcomes of people with a body mass index ≥40 kg/m2 were included. The primary outcome depended on the intervention but was commonly related to wound morbidity after cesarean delivery (ie, infection, separation, hematoma). METHODS: Meta-analysis was completed for interventions with at least 2 studies. Pooled risk ratios with 95% confidence intervals and heterogeneity (I2 statistics) were reported. RESULTS: Of 20,301 studies screened, 30 studies (17 cohort and 13 randomized controlled trials) encompassing 10 types of interventions were included. The interventions included delivery planning (induction of labor, planned cesarean delivery), antibiotics during labor induction or for surgical prophylaxis, 6 types of cesarean delivery techniques, and anticoagulation dosing after a cesarean delivery. Planned cesarean delivery compared with planned vaginal delivery did not improve outcomes according to 3 cohort studies. One cohort study compared 3 g with 2 g of cephazolin prophylaxis for cesarean delivery and found no differences in surgical site infections. According to 3 cohort studies and 2 randomized controlled trials, there was no improvement in outcomes with a non-low transverse skin incision. Ten studies (4 cohort and 6 randomized controlled trials) met the inclusion criteria for the meta-analysis. Two randomized controlled trials compared subcuticular closure with suture vs staples after cesarean delivery and found no differences in wound morbidity within 6 weeks of cesarean delivery (n=422; risk ratio, 1.09; 95% confidence interval, 0.75-1.59; I2=9%). Prophylactic negative-pressure wound therapy was compared with standard dressing in 4 cohort and 4 randomized controlled trials, which found no differences in wound morbidity (cohort n=2200; risk ratio, 1.19; 95% confidence interval, 0.88-1.63; I2=66.1%) or surgical site infections (randomized controlled trial n=1262; risk ratio, 0.90; 95% confidence interval, 0.63-1.29; I2=0). CONCLUSION: Few studies address interventions in people with a body mass index ≥40 kg/m2, and most studies did not demonstrate a benefit. Either staples or suture are recommended for subcuticular closure, but available data do not support prophylactic negative-pressure wound therapy after cesarean delivery for people with a body mass index ≥40 kg/m2.

What is an "ongoing" clinical trial? An analysis of different sources revealed heterogeneous definitions of when a clinical trial starts and ends: a meta-research study

ABSTRACT BACKGROUND: Although the concept of an "ongoing study" seems self-explanatory, it is difficult to determine whether a trial is underway. OBJECTIVE: To analyze the definitions of "ongoing clinical trial" across different clinical trial registries, methodological guidelines, and other sources. DESIGN AND SETTING: This meta-research study was conducted at the Universidade Federal de São Paulo (UNIFESP), Brazil. METHODS: We performed a cross-sectional analysis of relevant clinical trial registry databases, methodological guidelines for conducting systematic reviews, and other sources that would define or regulate clinical trials. RESULTS: We identified various heterogeneous definitions used by eligible sources at both the start and end of a clinical trial. The starting criteria used were as follows: when the team is planning the protocol, when permission is given to conduct the study, or when the first participant is enrolled. Some sources used the time at which the last outcome data was collected as a criterion to determine the end of the trial. The International Committee of Medical Journal Editors stated that a study is still "ongoing" during the analysis process. Several sources use a vague definition or present no clear criteria for defining the start or end of a study. CONCLUSION: The concept of "ongoing clinical trials" lacks a transparent and homogeneous definition across relevant sources. A consensus on this concept is important to facilitate the evaluation of available evidence and conduct research synthesis. Further efforts are necessary to determine the best definition for the start and end of a clinical trial.

¿Ensayos clínicos de superioridad, equivalencia o no inferioridad? / ¿Clinical trials of superiority, non-inferiority or equivalence?

La eficacia de una nueva intervención se establece generalmente a través de ensayos clínicos (EC) con asignación aleatoria (AA). Sin embargo, entre otros tantos desafíos metodológicos, el especificar la hipótesis de un EC con AA, sigue siendo un problema complejo de resolver para los investigadores clínicos. En este manuscrito discutimos las características de tres variantes de los EC con AA: EC de superioridad (ECS), EC de no-inferioridad (ECNI), y EC de equivalencia (ECE). Estos tres tipos de EC tienen supuestos diferentes sobre los efectos de una intervención, por lo que plantear hipótesis y definir objetivos requiere conocer algunos supuestos subyacentes a estos EC, incluso hasta elementos relacionados con la estimación del tamaño de muestra para cada cual. El objetivo de este manuscrito fue describir las diferencias metodológicas entre ECS, ECNI y ECE.

Efficacy and effectivity of new interventions are generally established through randomized clinical trials (RCTs). However, among many other methodological challenges, specifying the hypothesis of a RCT remains complex problem for clinical researchers. In this manuscript we discuss the characteristics of three variants of RCTs: superiority RCT (SRCT), non-inferiority RCT (NIRCT), and equivalence RCT (ERCT). These three types of RCT have different assumptions about the effects of an intervention, so setting hypotheses and defining objectives requires knowing some assumptions underlying these RCTs, including elements related to the estimation of the sample size for each one. The aim of this manuscript was to describe methodological differences between SRCT, NIRCT and ERCT.

WALANT versus intravenous regional anesthesia for carpal tunnel syndrome: a randomized clinical trial

ABSTRACT BACKGROUND: There are several anesthetic techniques for surgical treatment of carpal tunnel syndrome (CTS). Results from this surgery using the "wide awake local anesthesia no tourniquet" (WALANT) technique have been described. However, there is no conclusive evidence regarding the effectiveness of the WALANT technique, compared with the usual techniques. OBJECTIVE: To evaluate the effectiveness of the WALANT technique, compared with intravenous regional anesthesia (IVRA; Bier's block), for surgical treatment of CTS. DESIGN AND SETTING: Randomized clinical trial, conducted at Hospital Alvorada Moema and the Discipline of Hand Surgery, Universidade Federal de São Paulo (UNIFESP), São Paulo (SP), Brazil. METHODS: Seventy-eight patients were included. The primary outcome was measurement of perioperative pain through a visual analogue scale (VAS). The secondary outcomes were the Boston Questionnaire score, Hospital Anxiety and Depression Scale (HADS) score, need for use of analgesics, operating room times, remission of paresthesia, failures and complications. RESULTS: The WALANT technique (n = 40) proved to be superior to IVRA (n = 38), especially for controlling intraoperative pain (0.11 versus 3.7 cm; P < 0.001) and postoperative pain (0.6 versus 3.9 cm; P < 0.001). Patients spent more time in the operating room in the IVRA group (59.5 versus 46 minutes; P < 0.01) and needed to use more analgesics (10.8 versus 5.7 dipyrone tablets; P = 0.02). Five IVRA procedures failed (5 versus 0; P = 0.06). CONCLUSIONS: The WALANT technique is more effective than IVRA for CTS surgery.

Efficacy of intravaginal electrical stimulation added to bladder training in women with idiopathic overactive bladder: A prospective randomized controlled trial

ABSTRACT Purpose: To evaluate the efficacy of intravaginal electrical stimulation (IVES) added to bladder training (BT) on incontinence-related quality of life (QoL) and clinical parameters in women with idiopathic overactive bladder (OAB). Materials and Methods: Sixty-two women with idiopathic OAB were randomized into two groups using the random numbers generator as follows: Group 1 received BT alone (n:31), and Group 2 received BT+IVES (n:31). IVES was performed for twenty minutes three days a week over a course of eight weeks for a total of 24 sessions. Patients were evaluated in terms of incontinence severity (24-hour pad test), pelvic floor muscles strength (perineometer), 3-day voiding diary (frequency of voiding, nocturia, incontinence episodes and number of pads), symptom severity (OAB-V8), incontinence-related QoL (IIQ-7), treatment success (positive response rate), cure/improvement rate and treatment satisfaction (Likert scale). Results: A statistically significant improvement was found in all parameters for all groups at the end of the treatment compared to the baseline values except pelvic floor muscles strength in Group 1 (p <0.05). At the end of treatment, incontinence severity, frequency of voiding, nocturia, incontinence episodes, number of pads, symptom severity, and QoL were significantly improved in Group 2 compared to Group 1 (p <0.05). Treatment satisfaction, cure/improvement, and positive response rates were significantly higher in group 2 compared to Group 1 (p <0.05). Conclusion: We conclude that BT+IVES were more effective than BT alone on both incontinence-related QoL and clinical parameters in women with idiopathic OAB.

What do Cochrane systematic reviews say about interventions for treating psoriasis?

ABSTRACT CONTEXT AND OBJECTIVE: Psoriasis is a common chronic inflammatory skin disease characterized by abnormal and increased growth of the cells that produce keratin and abnormal functioning of the immune system. We aimed to summarize the evidence available regarding interventions for patients with psoriasis. DESIGN AND SETTING: Review of systematic reviews, developed in the Discipline of Evidence-Based Medicine, Escola Paulista de Medicina, Universidade Federal de São Paulo. METHODS: A systematic search was conducted to identify Cochrane systematic reviews that fulfilled the eligibility criteria. Two authors screened titles and abstracts that had been retrieved through the search strategy. The results from all the Cochrane systematic reviews that were included were summarized and presented in a narrative synthesis. RESULTS: We included six Cochrane systematic reviews assessing interventions for treating psoriasis. The findings from high-quality evidence were that (a) etanercept reduced the psoriasis severity index, compared with placebo and (b) steroids plus vitamin D, compared with vitamin D alone, improved the skin clearance rate, as assessed by investigators, but was associated with a higher proportion of participants who dropped out due to adverse events. For all other comparisons, the quality of the evidence ranged from moderate to very low. CONCLUSION: This review included six Cochrane systematic reviews that provided evidence ranging in quality from unknown to high, regarding management of psoriasis. Further randomized controlled trials are imperative to reduce the uncertainties relating to several treatments that are already used in clinical practice.

Estudios experimentales 1 Parte: el ensayo clínico / Experimental studies 1st Part: clinical trial

Los estudios experimentales, se caracterizan por la valoración del efecto de una o más intervenciones, habitualmente de forma comparativa con otra intervención, o un placebo; y el carácter prospectivo, de la recolección de los datos y el seguimiento de los grupos en estudio. Bajo la denominación de estudios experimentales, existe una diversidad de diseños, desde los ensayos clínicos (EC) y sus variantes, hasta los estudios cuasi-experimentales y los experientos naturales. El objetivo de este manuscrito, es reportar los principios básicos, características y estructura de un EC.

Experimental studies are characterized by the assessment of effect of one or more interventions, usually comparatively with other intervention, or placebo; and the prospective nature of data collection and follow-up. Included in the term experimental studies, there are a variety of designs: Clinical trials (CT) and its variants, quasi-experimental studies and natural experiments. The aim of this manuscript is to report basic principles, characteristics and CT structure.

Overview of systematic reviews - a new type of study. Part II / Overview de revisões sistemáticas - um novo tipo de estudo. Parte II

CONTEXT AND OBJECTIVE: Overviews of Systematic Reviews (OoRs) are a new type of study in which multiple evidence from systematic reviews (SRs) is compiled into an accessible and useful document. The aim here was to describe the state of the art and critically assess Cochrane OoRs that have been published. DESIGN AND SETTING: Descriptive study conducted at a research center. METHODS: The OoRs identified through the filter developed in Part I of this study were evaluated in five domains: methodological quality; quality of evidence; implications for practice; general profile of OoRs; and length of work. RESULTS: All 13 OoRs included had high methodological quality. Some OoRs did not present sufficient data to judge the quality of evidence; using sensitivity analysis, the quality of evidence of the OoRs increased. Regarding implications for practice, 64% of the interventions were judged as beneficial or harmful, while 36% of them showed insufficient evidence for judgment. It is expected (with 95% confidence interval) that one OoR will include 9,462 to 64,469 patients, 9 to 29 systematic reviews and 80 to 344 primary studies, and assess 6 to 21 interventions; and that 50 to 92% of OoRs will produce meta-analysis. The OoRs generated 2 to 26 meta-analyses over a period of 18 to 31 months. CONCLUSION: The OoRs presented high methodological quality; the quality of evidence tended to be moderate/high; most interventions were judged to be beneficial/harmful; the mean length of work was 24 months. The OoR profile adds power to decision-making. .

CONTEXTO E OBJETIVO: Overviews de revisões sistemáticas (OoRs) representam um novo tipo de estudo que compila múltiplas evidências de revisões sistemáticas (SRs) em um documento acessível e útil. O objetivo foi de descrever o estado da arte e avaliar criticamente as OoRs Cochrane publicadas. DESENHO E LOCAL: Estudo descritivo realizado em centro de pesquisa. MÉTODOS: As OoRs identificadas através do filtro desenvolvido na parte I deste estudo foram avaliadas por cinco domínios: qualidade metodológica, qualidade da evidência, implicações para a prática, perfil geral das OoRs e tempo de execução. RESULTADOS: As 13 OoRs incluídas apresentaram alta qualidade metodológica. Algumas OoRs não apresentavam dados suficientes para julgar a qualidade da evidência; com a análise de sensibilidade, a qualidade evidência nas OoRs aumentou. Implicações para prática foram julgadas como benéficas ou danosas em 64% das intervenções; em 36% das intervenções há evidências insuficientes para o julgamento. É esperado (com intervalo de confiança de 95%) que uma OoR inclua 9.462 a 64.469 pacientes, 9 a 29 revisões sistemáticas e 80 a 344 estudos primários, e avaliem entre 6 e 21 intervenções; que 50 a 92% das OoRs realizem metanálise. As OoRs geraram entre 2 e 26 metanálises em um período de 18 a 31 meses. CONCLUSÃO: As OoRs apresentam alta qualidade metodológica; a qualidade da evidência tende a ser alta/moderada; as intervenções, em sua maioria, foram julgadas como benéficas/danosas; o tempo de execução foi de 24 meses em média. O perfil das OoRs potencializa a tomada de decisão. .

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. ...

Collaborative multicenter trials in Latin America: challenges and opportunities in orthopedic and trauma surgery / Estudos colaborativos na America Latina: desafios e oportunidades em cirurgia ortopedica e traumatologica

CONTEXT AND OBJECTIVE Orthopedic research agendas should be considered from a worldwide perspective. Efforts should be planned as the means for obtaining evidence that is valid for health promotion with global outreach. DESIGN AND SETTING Exploratory study conducted at Universidade Federal de São Paulo (Unifesp), São Paulo, Brazil, and McMaster University, Hamilton, Canada. METHODS We identified and analyzed collaborative and multicenter research in Latin America, taking into account American and Canadian efforts as the reference points. We explored aspects of the data available from official sources and used data from traffic accidents as a model for discussing collaborative research in these countries. RESULTS The evaluation showed that the proportion of collaborative and multicenter studies in our setting is small. A brief analysis showed that the death rate due to traffic accidents is very high. Thus, it seems clear to us that initiatives involving collaborative studies are important for defining and better understanding the patterns of injuries resulting from orthopedic trauma and the forms of treatment. Orthopedic research may be an important tool for bringing together orthopedic surgeons, researchers and medical societies for joint action. CONCLUSIONS We have indicated some practical guidelines for initiatives in collaborative research and have proposed some solutions with a summarized plan of action for conducting evidence-based research involving orthopedic trauma. .

CONTEXTO E OBJETIVOS A programação de pesquisa em ortopedia deve ser considerada do ponto de vista global. Esforços devem ser planejados como forma de se obter evidência que seja válida para promoção da saúde de alcance mundial. TIPO DE ESTUDO E LOCAL Estudo exploratório conduzido na Universidade Federal de São Paulo (Unifesp), São Paulo, Brasil e na McMaster University, Hamilton, Canadá. MÉTODOS Identificamos e analisamos pesquisas multicênticas/colaborativas realizadas na América Latina, considerando os esforços nos Estados Unidos e Canadá como referência. Para tal, exploramos os aspectos dos dados disponíveis em fontes oficiais e utilizamos os dados provenientes de acidentes de trânsito como modelo de discussão de pesquisas colaborativas nestes países. RESULTADOS A avaliação demonstra uma pequena proporção de estudos colaborativos/multicêntricos em nosso meio. Análise breve demonstrou que existe enorme proporção de mortes devidas a traumas provenientes dos acidentes de trânsito. Dessa forma, parece-nos claro que iniciativas envolvendo estudos colaborativos são importantes para a definição e melhor entendimento do padrão das lesões provenientes de trauma ortopédico e as formas de tratamento. A pesquisa ortopédica pode ser importante ferramenta para aglutinar cirurgiões ortopédicos, pesquisadores e sociedades médicas para uma ação em conjunto. CONCLUSÕES Apontamos algumas diretrizes práticas para iniciativas em pequisas colaborativas e propusemos algumas soluções com um plano de ação resumido para a realização de pesquisa baseada em evidências envolvendo trauma ortopédico. .

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.

Eficacia de la terapia homeopática contra tratamiento convencional en extracciones de dientes temporales / Efficacy of the homeopathic therapy against conventional treatment in extractions of temporary teeth

Se realizó un ensayo clínico, fase II tardía, unícéntrico, no secuencial y controlado aleatorizado en la Clínica Estomatológica «Mártires de Pino 3¼ desde octubre de 2004 a mayo de 2005 con el objetivo de determinar la eficacia de la terapia homeopática comparada con el tratamiento convencional en extracciones de dientes temporales. La muestra estuvo constituida por 70 pacientes, divididos en dos grupos equitativos (estudio y control). A los pacientes seleccionados se le suministraron los remedios homeopáticos Hypericum Perforatum y árnica Montana, ambos a las 200Ch, o el tratamiento convencional según pertenecieran a uno u otro grupo. Se determinó que el comportamiento de los niños del grupo estudio fue mejor al suministrar el método elegido (cooperativo en el 94.3 %). La evaluación de la eficacia se realizó según la existencia de complicaciones trans y posoperatorias, durante el acto quirúrgico y 48h después del mismo. Se comprobó la eficacia de la analgesia homeopática.

ABSTRACT A late II phase, unicentric, controlled and not sequential randomized clinical trial at «Mártires de Pino 3¼ Odontology Clinic was carried out, from October 2004 to May 2005 with the aim to determine the efficacy of the homeopathic therapy compared with the conventional treatment in extractions of temporary teeth. The sample was constituted by 70 patients, divided into two equitable groups (study and control). Homeopathic remedies Hypericum Perforatum and Arnica Montana were supplied to the patients selected, both to the 200Ch, or the conventional treatment as belong to one or another group. It was determined that children's behaviours of the study group was better upon supplying the chosen method (cooperative in the 94.3%). The efficacy assessment according to the existence of complications trans and postoperative was performed, during the surgical act and 48h after it. The efficacy of the homeopathic analgesia was verified.

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.