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.

Low-intensity extracorporeal shockwave therapy in the treatment of erectile dysfunction - a narrative review

ABSTRACT Objectives: To provide an overview of low-intensity extracorporeal shockwave therapy (LIEST) for erectile dysfunction (ED), pointing out which concepts are already consolidated and which paths we still need to advance. Materials and Methods: We performed a narrative review of the literature on the role of shockwave therapies in erectile dysfunction, selecting publications in PUBMED, including only relevant clinical trials, systematic reviews and meta-analyses. Results: We found 11 studies (7 clinical trials, 3 systematic review and 1 meta-analysis) that evaluated the use of LIEST for the treatment of erectile dysfunction. One clinical trial evaluated the applicability in Peyronie's Disease and one other clinical trial evaluated the applicability after radical prostatectomy. Conclusions: The literature presents little scientific evidence but suggests good results with the use of LIEST for ED. Despite a real optimism since it is a treatment modality capable of acting on the pathophysiology of ED, we must remain cautious, until a larger volume of higher quality studies allows us to establish which patient profile, type of energy and application protocol will achieve clinically satisfactory results.

Group physiotherapy and quality of life in parkinsonism: quasi-experimental study

According to systematic reviews, a short-term treatment of aquatic physiotherapy, mind-body therapies and exergame improve quality of life of people with parkinsonism. But few studies examined the group physiotherapy effects on quality of life of people with parkinsonism. Objective: We aimed to investigate the short-term effects of group physiotherapy protocols on the quality of life of people with Parkinson's disease or secondary parkinsonism. Methods: This is a quasi-experimental study, a controlled, non-randomized, unmasked trial, with consecutive arms for one group and parallel to another, with 15 participants with parkinsonism. They were organized in 3 groups: OG-E1wI (n = 9), observed group treated with group physiotherapy once a week; EG-C (n = 6), in the control phase without treatment, concomitant with OG-E1wI; EG-2wI (n = 6), the same subjects as EG-C, they were treated with group physiotherapy twice a week, in a posterior consecutive phase. The PDQ-39 scale was used to assess Quality of Life. Results: The mean differences between OG-E1wI and EG-C and between EG-2wI and EG-C in the various domains of PDQ-39 were not statistically significant. Conclusion: A group physiotherapy protocols performed once or twice a week may not be enough to improve quality of life for people with parkinsonism. The literature suggests that group physiotherapy protocols performed three to five times a week improve quality of life in a short period

Contexto: Revisões sistemáticas sugerem que fisioterapia aquática, terapias corporais complementares e exergame aumentam a qualidade de vida da pessoa com parkinsonismo em tratamento de curto prazo. Porém, os efeitos da fisioterapia em grupo na qualidade de vida da pessoa com parkinsonismo são pouco estudados. Objetivo: Investigar os efeitos em curto prazo de protocolos de fisioterapia grupal sobre a Qualidade de Vida de pessoas com doença de Parkinson e parkinsonismo secundário. Métodos: Estudo quasi-experimental, ensaio controlado não randomizado, sem mascaramento, com braços consecutivos para um grupo e paralelo para outro, com 15 participantes com parkinsonismo. Os participantes foram organizados em 3 grupos: OG-E1wI (n= 9), intervenção de fisioterapia em grupo uma vez por semana; EG-C (n= 6), em fase controle sem tratamento, concomitante ao OG-E1wI; EG-2wI (n=6), os mesmos sujeitos do EG-C, em fase consecutiva com intervenção de fisioterapia em grupo, duas vezes por semana. A escala PDQ-39 foi utilizada para avaliar a Qualidade de Vida. Resultados: As diferenças médias entre OG-E1wI e EG-C e entre EG-2wI e EG-C nos vários domínios da PDQ-39 não são estatisticamente significativas. Conclusão: Protocolos de fisioterapia em grupo com frequência de uma ou duas vezes por semana podem não ser suficiente para promover ganhos na qualidade de vida de pessoas com parkinsonismo. A literatura sugere que protocolos de fisioterapia em grupo feitos três a cinco vezes por semana obtêm ganho de qualidade de vida em um período de curto prazo

Hidroxicloroquina para Pacientes com COVID-19 não Hospitalizados: Uma Revisão Sistemática e Metanálise de Ensaios Clínicos Randomizados / Hydroxychloroquine for Non-Hospitalized COVID-19 Patients: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

Resumo Fundamento: Revisões sistemáticas anteriores não identificaram benefício do uso da hidroxicloroquina ou da cloroquina em pacientes com COVID-19 não hospitalizados. Após a publicação dessas revisões, os resultados do COPE, o maior ensaio clínico randomizado até hoje, tornaram-se disponíveis. Objetivos: Conduzir uma revisão sistemática e metanálise de ensaios clínicos randomizados (ECRs) para sintetizar as evidências sobre a eficácia e a segurança da hidroxicloroquina e da cloroquina em pacientes com COVID-19 não hospitalizados em comparação a controle ou tratamento padrão. Métodos: As buscas foram conduzidas nos bancos de dados PubMed, Embase, The Cochrane Library e ClinicalTrials.gov, e complementadas por busca manual. Foram realizadas metanálises diretas e avaliações de risco de viés e certeza da evidência, incluindo análise do tamanho ótimo da informação (OIS, optimal information size). Um nível de significância de 0,05 foi adotado na metanálise. PROSPERO: CRD42021265427. Resultados: Oito ECRs com 3219 participantes foram incluídos. As taxas de internação por COVID-19 e de eventos adversos não foram significativamente diferentes entre hidroxicloroquina (5,6% e 5,1%) e controle (7,4% e 20,4%) [risco relativo (RR) 0,77, intervalo de confiança 95% (IC95%), 0,57-1,04, I2: 0%; RR 1,78, IC95% 0,90; 3,52, I2: 93%, respectivamente)]. O OIS (7880) não foi alcançado para hospitalização por COVID-19, independentemente da simulação para a taxa de evento e redução do RR estimados. Conclusão: A evidência de muito baixa qualidade indicou falta de benefício com hidroxicloroquina em prevenir internações por COVID-19. Apesar de ser a revisão sistemática com o maior número de participantes incluídos, o OIS, considerando a resposta à infecção anterior à vacinação, não foi atingido.

Abstract Background: Previous systematic reviews have identified no benefit of hydroxychloroquine and chloroquine in non-hospitalized COVID-19 patients. After publication of these reviews, the results of COPE, the largest randomized trial conducted to date, became available. Objectives: To conduct a systematic review and meta-analyses of randomized clinical trials (RCTs) to synthesize the evidence on the efficacy and safety of hydroxychloroquine and chloroquine for non-hospitalized COVID-19 patients compared to placebo or standard of care. Methods: Searches were conducted in PubMed, Embase, The Cochrane Library, and ClinicalTrials.gov complemented by manual search. Pairwise meta-analyses, risk of bias, and evidence certainty assessments were conducted, including optimal information size analysis (OIS). A level of significance of 0.05 was adopted in the meta-analysis. PROSPERO: CRD42021265427. Results: Eight RCTs with 3,219 participants were included. COVID-19 hospitalization and any adverse events rates were not significantly different between hydroxychloroquine (5.6% and 35.1%) and control (7.4% and 20.4%) (risk ratio, RR, 0.77, 95% confidence interval, CI, 0.57-1.04, I2: 0%; RR 1.78, 95%-CI 0.90; 3.52, I2: 93%, respectively). The OIS (7,880) was not reached for COVID-19 hospitalization, independently of the simulation for anticipated event rate and RR reduction estimate. Conclusion: Evidence of very low certainty showed lack of benefit with hydroxychloroquine in preventing COVID-19 hospitalizations. Despite being the systematic review with the largest number of participants included, the OIS, considering pre-vaccination response to infection, has not yet been reached.

Anti-inflammatory treatment after selective laser trabeculoplasty: a systematic review of the literature and meta-analysis of randomized control trials / Tratamento anti-inflamatório após trabeculoplastia seletiva a laser: revisão sistemática da literatura e meta-análise de ensaios clínicos randomizados controlados

ABSTRACT We assessed the effects of anti-inflammatory treatment after selective laser trabeculoplasty through a systematic search of the MEDLINE, COCHRANE, and ClinicalTrials.gov. The outcome measures were intraocular pressure, anterior chamber inflammation, and discomfort. Evidence synthesis was performed using fixed effects or random-effects model according to the heterogeneity of the included studies. Heterogeneity was assessed using Q-statistic and I2. For an overall estimate of continuous outcomes, the mean differences and their 95% confidence intervals were applied, while odds ratios and their 95% confidence intervals were applied for dichotomous outcomes. Six studies were included in all. No significant difference was noted in the patients for intraocular pressure and discomfort when treated with anti-inflammatory drops. However, the patients showed benefit from reduced anterior chamber inflammation in the first postoperative week [FE OR=0.43, 95% CI=(0.19, 0.95), PQ=0.97, I2=0%], with no significant difference between the outcomes of non-steroidal anti-inflammatory drugs and steroids [FE OR=0.75, 95% CI=(0.20, 2.82), PQ=0.37, I2=0%]. Anti-inflammatory drops reduce anterior chamber inflammation after selective laser trabeculoplasty but showed no effect on the intraocular pressure.

RESUMO O objetivo deste estudo é avaliar os efeitos do tratamento anti-inflamatório após a trabeculoplastia seletiva a laser. Uma busca sistemática foi feita no MEDLINE, COCHRANE e ClinicalTrials.gov. As medidas de resultado foram pressão intraocular, inflamação da câmara anterior e desconforto. A síntese de evidência foi realizada utilizando-se modelo de efeitos fixos ou efeitos aleatórios, de acordo com a heterogeneidade dos estudos incluídos. A heterogeneidade foi avaliada utilizando-se Q-statistic e I². Para uma estimativa global dos resultados contínuos, foram usadas diferenças médias e seus intervalos de confiança de 95% enquanto para resultados dicótomos, usou-se odds ratios e seus intervalos de confiança de 95%. Seis estudos foram incluídos. Nenhuma diferença significativa foi encontrada em pacientes tratados com gotas anti-inflamatórias em termos de pressão intraocular e desconforto. No entanto, eles se beneficiaram da redução da inflamação da câmara anterior na primeira semana pós-operatória [FE OR=0,43, IC 95% = (0,19, 0,95), PQ=0,97, I2=0%], sem diferença significativa entre anti-inflamatórios não esteroidais e esteroidais [FE OR=0,75, IC 95% = (0,20, 2,82), PQ=0,37, I2=0%]. Gotas anti-inflamatórias reduzem a inflamação da câmara anterior após trabeculoplastia seletiva a laser, não afetando a pressão intraocular.

Fixed and on-demand regimens of acetaminophen in periodontal surgery: randomized clinical trial

Aim: to evaluate the clinical efficacy of an acetaminophen analgesic by comparing its prescription in fixed versus ondemand schedules after periodontal surgery. The hypothesis of the study was that the fixed regimen would be more effective than the on-demand regimen for postoperative analgesics following periodontal surgery. Methods: An open randomized clinical trial was conducted. The 68 patients who needed total flap surgery to restore supracrestal tissue attachment or surgical treatment of periodontitis were randomized". Visual Analogue Scale was used to assess pain. The fixed group (n = 34) received 500 mg of acetaminophen every 4 hours for 2 days. The on-demand group (n = 34) was instructed to use the acetaminophen "as needed," at intervals of no less than 4 hours between doses. Ibuprofen was the rescue medication for both groups. Pain scores and medication use were recorded 2, 6, 12, 24 and 48 hours after the surgical procedure. The study was registered at the Brazilian Registry of Clinical Trials under RBR-7wv259. Results: The two groups did not differ in relation to the frequency or the intensity of pain in a 48-hour period (n=20 in the fixed group, and n=22 in the on-demand group), or even in the intention-to-treat (n=34 in each group). Individuals who experienced moderate to severe pain used rescue medication more frequently in both groups. No adverse events were reported. Conclusion: Both regimens were effective in controlling postoperative pain after periodontal surgery

Evaluation of outcomes in intervention randomized clinical trials - distal radius fractures / Avaliação dos desfechos em ensaios clínicos randomizados de intervenção - fraturas distais do rádio

ABSTRACT Objectives: Describe the frequency and types of outcomes in randomized clinical trials (RCT) of intervention for distal radius fractures, analyze how confusing outcome presentations can lead to misinterpretations, and suggest strategies to improve the reader's understanding of the decision-making process. Methods: A retrospective study was conducted through a systematized search on the PubMed® database in the last 10 years, in which only intervention RCT was included for distal radius fractures, and outcomes were analyzed. Results: Of the primary outcomes analyzed in the 75 selected articles, 46.6% were classified as clinical outcomes, 20% as surrogate, 30.6% as composite, 1.3% as complex scales, and 1.3% as safety outcomes. 34.7% of the articles did not report adverse events. Conclusion: The presentation of outcomes with little clinical relevance represented more than half of the sample (53.4%) - such studies can harm the reader since they confuse the interpretation of scientific evidence; the Core Outcome Measures in Effectiveness Trials (COMET) initiative could help health professionals in understanding and selecting the most appropriate therapeutic interventions for patients. Level of Evidence III; Retrospective comparative study .

RESUMO Objetivos: Descrever a frequência e os tipos de desfechos em ensaios clínicos randomizados (RCT) de intervenção para fraturas distais do rádio, analisar como apresentações confusas de desfechos podem levar a interpretações equivocadas e sugerir estratégias para melhorar a compreensão do leitor sobre o processo de tomada de decisão. Métodos: Foi realizado estudo retrospectivo mediante busca sistematizada na base de dados PubMed® nos últimos 10 anos, na qual foram incluídos apenas RCT de intervenção para fraturas do segmento distal do rádio, cujos desfechos foram analisados. Resultados: Dos desfechos primários analisados nos 75 artigos selecionados, 46,6% foram classificados como desfechos clínicos, 20% como substitutos, 30,6% como compostos, 1,3% como escalas complexas e em 1,3% como desfechos de segurança. 34,7% dos artigos não reportaram eventos adversos. Conclusão: A apresentação de desfechos com pouca relevância clínica representou mais da metade da amostra (53,4%) - tais estudos podem prejudicar o leitor, uma vez que confundem a interpretação das evidências científicas; a iniciativa Core Outcome Measures in Effectiveness Trials (COMET) auxilia os profissionais de saúde na compreensão e seleção das intervenções terapêuticas mais adequadas para os pacientes. Nível de Evidência III; Estudo retrospectivo comparativo .

Effect of dentifrices with different pH and fluoride concentrations on fluoride levels in biofilm and nails: an RCT

Abstract: Purpose: to evaluate the effect of dentifrice pH and fluoride concentration ([F]) on fluoride uptake on the biofilm and nails of children from a non-fluoridated area. Methods: two hundred and twenty-eight two- to four-year-old children were randomly allocated into 3 groups according to the type of dentifrice: G1: 1100 μg F/g, pH 4.5 (n = 76); G2: 750 μg F/g, pH 4.5 (n = 74); and G3: 1100 μg F/g, pH 7.0 (n = 78). Nails were collected at 4, 8, and 12 months after starting dentifrice use and biofilm was collected 5 and 60 minutes after toothbrushing. The concentrations of F in nails and biofilm were analyzed by HMDS facilitated diffusion. Data were analyzed by Kruskal-Wallis/Mann-Whitney's test and the comparison between biofilm collection times was done using Wilcoxon test (p £ 0.05). Results: a significant reduction of [F] in biofilm was observed 60 minutes after toothbrushing, regardless of the dentifrice used. However, 5 minutes after toothbrushing, G1 had a significantly higher [F] compared to G2 and G3, and 60 minutes after toothbrushing, [F] was significantly higher for G1 and G2 compared to G3. G1 and G3 had significantly higher [F] in the nails compared to G2. Conclusion: a lower dentifrice concentration is a relevant factor for the reduction of excessive fluoride intake. The use of a low-F acidified dentifrice combines the reduction of fluoride uptake with caries prevention by leading to greater incorporation of F into the biofilm over time.

The Xylitol Applicability and its Effects in Health Area Worldwide: A Bibliometric Analysis Based on Randomized Controlled Trials

ABSTRACT Objective To describe and evaluate the xylitol products' applicability and its effects in the health area worldwide utilizing a bibliometric analysis from randomized controlled trials (RCT) with humans. Material and Methods Electronic searches were carried out in Medline/PubMed, Scopus, Cochrane Library, Web of Science, and VHL databases. The main data extracted were: year, area of applicability, type of treatment, country, journal, xylitol posology and concentration, presentation form, outcomes, and effects. Results From 1476 studies, 257 were included. These studies were published between 1973-2021. The majority was carried out in dentistry (73.9%) and under preventive treatment (67.4%). These studies were developed in the USA (15.4%) and published in Caries Research (6.6%). The posology and concentration ranged between 0.004-67 g/day and 0.002-100%, respectively. The xylitol is usually used in the chewing gum form (44.0%), and for antimicrobial activity evaluation (38.5%). A positive effect was observed in 204 studies (79.3%) and was associated with xylitol concentration ≥ 15(p=0.007). Side effects were reported in 8.2and were associated with posology ≥ 5 g/day (p=0.03). Conclusion Most studies with xylitol were conducted to prevent diseases in the dentistry field. The chewing gum form and antimicrobial activity evaluation were more frequent. Most xylitol products have a positive effect, and few studies report side effects.

Effectiveness of exogenous melatonin on delirium in critically ill patients: a meta-analysis / 国际脑血管病杂志

Objective:To evaluate the effectiveness of exogenous melatonin in preventing delirium in critically ill patients.Methods:The computer searched Pubmed, Medline, Embase, Web of Science, the Cochrane Library and other English databases for randomized controlled trials on the efficacy of exogenous melatonin in the prevention of delirium in critically ill patients. The retrieval time was from the establishment of the database to March 2021. Two researchers independently screened the literature, extracted data and evaluated the quality according to the inclusion and exclusion criteria. Revman 5.3 software was used for meta-analysis.Results:A total of 10 randomized controlled trials and 1 224 critically ill patients were included. The results of meta-analysis showed that there were no significant differences in the incidence of delirium during hospitalization (relative risk [ RR] 0.72, 95% confidence interval [ CI] 0.47-1.09; Z=1.57, P=0.12), ICU hospitalization time (mean difference [ MD] -0.36, 95% CI -1.01-0.28; Z=1.11, P=0.27), mechanical ventilation time ( MD -49.42, 95% CI -126.63-27.80; Z=1.25, P=0.21) and mortality ( RR 0.74, 95% CI 0.42-1.30; Z=1.05, P=0.29) between the experimental group and the control group. Conclusion:Exogenous melatonin can not prevent the occurrence of delirium in critically ill patients, nor can it shorten the hospitalization time and mechanical ventilation time in intensive care unit and reduce the mortality.

Transcatheter aortic valve implantation versus surgical aortic valve replacement for treatment of severe aortic stenosis: comparison of results from randomized controlled trials and real-world data

Abstract Objective: Results from randomized controlled trials (RCTs) and real-world study (RWS) appear to be discordant. We aimed to investigate whether data derived from RCTs and RWS evaluating long-term all-cause mortality of transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis (AS) were in agreement. Methods: RCTs or RWS comparing TAVI and SAVR, reporting longterm (≥2-year follow-up) all-cause mortality, were identified. We also carried out subgroup analyses to access the effect in different subgroups. A pre-designated data extraction form including 5 domains and 26 items was used to explore the relationship between RCTs and RWS. Mortality and effect in different subgroups were evaluated using random-effects meta-analyses. Results: Five RCTs (5421 participants, TAVI: 2759, SAVR: 2662) and 33 RWS (20839 participants; TAVI: 6585, SAVR: 14254) were identified. Pooled RCT analysis showed no difference in all-cause mortality between TAVI and SAVR (HR=0.97, 95% CI: 0.88-1.07; P=0.55). In RWS, TAVI was associated with an increased risk of allcause mortality (HR=1.46, 95% CI: 1.26-1.69; P<0.001) compared to SAVR. Conclusion: These results highlight the inconsistencies between RCTs and RWS in assessing long-term all-cause mortality in the treatment of AS using TAVI or SAVR, which may be caused by interactions of clinical characteristics or study design. RCTs as well as RWS are both developing and improving; the advantages of one kind of design, measurement and evaluation can and should be thoughtfully referred to the other.

Advances in therapeutic drugs for nonalcoholic steatohepatitis / 临床肝胆病杂志

The incidence rate of nonalcoholic steatohepatitis is gradually increasing year by year, which calls for an urgent need for effective therapeutic drugs. In recent years, various drugs have been developed, including anti-oxidative stress drugs, insulin sensitizers, PPAR agonists, thyroid receptor agonists, farnesoid X receptor agonists, ASK1 inhibitors, and pan-caspase inhibitors. This article reviews the clinical studies on the therapeutic drugs for nonalcoholic steatohepatitis and summarizes the efficacy and safety of each drug, in order to provide a reference for clinical practice.

Diclofenac diethylamine emulgel delivery via nano plum-blossom needle for acute gouty arthritis: study protocol for a single-center blind randomized controlled trial / 国际中医中药杂志

Background@#Patients with acute gouty arthritis experienc severe pain and often have concomitant limited joint movement. High-dose intake of anti-inflammatory analgesics often results in adverse reactions, such as nausea, vomiting, and diarrhea, and might increase the risk of gastrointestinal bleeding. In order to reduce the adverse reactions by oral intake, local use of externally useddrugs with the same active ingredients as the oral intake is an option in clinical practice. However, externally useddrugs take effect slowly and efficacy to reduce painful feelingis unsatisfactory. Therefore, it is demanding to develop a safe and effective treatment plan. In this regard, researchers have put up a hypothesis. The skin of the human body has a dense stratum corneum, which is difficult for externally used drugs to penetrate effectively; if the keratin barrier of the skin around affected joints can be broken without further damaging the skin, externally applied drugs may safely and effectively alleviate the local symptoms of acute gouty arthritis. The nano plum blossom needle is made of a modern new material. The needle body is thin and the diameter of the needle tip is only 300 nm. The needle is used clinically to break through the keratin barrier of the human skin and promote the absorption of external medicine. Therefore, this trial was designed to preliminarily evaluate the safety and effectiveness of using the nano plum blossom needle for the introduction of diclofenac diethylamine emulgel in the treatment of acute gouty arthritis.@*Methods@#A randomized controlled trial including 83 patients with acute gouty arthritis was conducted, who was assigned to three groups, the intervention group, control group 1, and control group 2 in a ratio of 2:2:1, respectively. The nano plum blossom needle was used for the introduction of diclofenac diethylamine emulgel in the intervention group; the nano plum blossom needle was used as a placebo along with the local use of diclofenac diethylamine emulgel in control group 1; and the nano plum blossom needle was used alone in control group 2. The treatments were applied once a day until the pain was completely relieved and the course of treatment lasted up to 7 days. The primary outcome measurement was the visual analog scale for evaluating the degree of pain. The secondary outcome indicators included scoring of the symptoms and signs with comprehensive consideration of the joint skin color, local tenderness, and degree of joint motion, the time and dose of emergency medication usage during trial, and adverse events.@*Discussion@#This trial couldprovide preliminary evidence for evidence-based practice of using nano plum blossom needle transdermal drug delivery technology for diclofenac diethylamine emulgel for the treatment of acute gouty arthritis, and provide a reference for sample size calculation and experimental design of future clinical trials verifying the effectiveness and safety of such a technical scheme in a larger target population.@*Registration information@#This study has been registered in the China Clinical Trial Registry Centerwith the registration code of ChiCTR-IOR-17012154.

Visual data: a new tool to improve the presentation of clinical trial results / Dados visuais: uma nova ferramenta para melhorar a interpretação dos resultados de ensaios clínicos

ABSTRACT Randomized controlled trials are known to be the best tool to determine the effects of an intervention; however, most healthcare professionals are not able to adequately understand the results. In this report, concepts, applications, examples, and advantages of using visual data as a complementary tool in the results section of original articles are presented. Visual simplification of data presentation will improve general understanding of clinical research.

RESUMO Ensaios clínicos randomizados são conhecidos por serem a melhor ferramenta para determinar os efeitos de uma intervenção. No entanto, a maioria dos profissionais de saúde não é capaz de compreender os resultados de forma adequada. Neste artigo, são apresentados conceitos, aplicações, exemplos e vantagens do uso de dados visuais como uma ferramenta complementar na seção dos resultados de artigos originais. A simplificação da visualização da apresentação dos dados deve melhorar o entendimento geral de pesquisas clínicas.

The Effect of Schroth Therapy on Thoracic Kyphotic Curve and Quality of Life in Scheuermann's Patients: A Randomized Controlled Trial

STUDY DESIGN: Randomized controlled single-blinded clinical trial. PURPOSE: To evaluate the efficacy of Schroth therapy on thoracic curve angle, pain, and self-perceived body image (SPBI) of the back in Scheuermann's patients in comparison with the efficacy of classic anti-gravitation exercises. OVERVIEW OF LITERATURE: Scheuermann disease is the most common cause of hyperkyphosis of the thoracic and thoracolumbar spine during adolescence. However, very few studies evaluated the effect of exercises on the progression of kyphosis in Scheuermann patients. Schroth three-dimensional exercise therapy was found in several studies to be effective in the treatment of adolescent scoliosis; however, we found no randomized controlled trials that evaluated the efficacy of this method in Scheuermann patients. METHODS: A total of 50 young adults (males and females) with Scheuermann's disease were randomly divided into either the experimental group (Schroth therapy treatment, n=25) or the control group (classic anti-gravitation exercises, n=25). Participants in both the groups were provided a course of individual treatment sessions during few weeks, with one appointment per week. They were required to perform the exercises daily throughout the study period (12 months) and fill their performance in a research log. We evaluated the thoracic Cobb angle (main outcome measure), pain, SPBI, flexion of the shoulder (supine), flexion of the shoulder (standing), kyphotic deformity measured using inclinometer, and L5 kyphosis apex line (L5-KAL) as well as administered the Scoliosis Research Society-22 Questionnaire for the participants before the treatment, after 6 months, and 1 year postoperatively. These results were then compared. RESULTS: In the mixed analysis of variance, the main effect of time was significant in the thoracic kyphosis (F [1]=5.72, p=0.02), and in the L5-KAL (F [1]=5.76, p=0.02). The main effect of time on the kyphotic deformity, measured using an inclinometer, did not reach the significance level; however, it showed the tendency (F [1]=2.80, p=0.07). In the group-by-time interaction, a significant difference was found in the thoracic kyphosis (F [1]=4.91, p=0.03) and in the kyphotic deformity, measured using an inclinometer (F [1]=4.05, p=0.02). Thus, the Schroth therapy group showed significantly greater improvement than the classic anti-gravitation exercises group. CONCLUSIONS: The present findings indicate that back exercises in general, and Schroth therapy in particular, is an effective treatment for preventing and significantly improving the thoracic Cobb angle and symptomatic representation in Scheuermann's patients.

Meniscectomía artroscópica en 100 pacientes / Arthroscopic meniscectomy in 100 patients

Fundamento: las lesiones del menisco en la articulación de la rodilla son una de las enfermedades más frecuentes debido a causas traumáticas y degenerativas, el cuadro clínico se caracteriza por la presencia de síntomas y signos mecánicos y el tratamiento por lo general es quirúrgico por la vía artroscópica que es de gran utilidad. Objetivo: evaluar la efectividad de la meniscectomía por vía artroscópica en un grupo de pacientes con lesión de menisco. Métodos: se realizó un estudio cuasi experimental modalidad antes y después, en 100 pacientes operados por meniscectomía mediante la vía artroscópica, la investigación tiene un nivel de evidencia III, recomendación B y fue realizada en el hospital Universitario Manuel Ascunce Domenech de la ciudad de Camagüey desde febrero de 2013 a enero de 2017. El universo estuvo compuesto por 158 pacientes de los cuales 100 fueron seleccionados para integrar la muestra no probabilística. Resultados: el promedio de edades fue de 46,95 años, predominó el sexo femenino, la rodilla derecha y el menisco medial. El desgarro de tipo degenerativo se observó en el 50 % de los casos, la plica sinovial se detectó en 41 enfermos y las lesiones de cartílago en 78. El dolor en la línea articular y la maniobra de McMurray presentaron el mayor porcentaje de positividad. La meniscectomía parcial fue el procedimiento quirúrgico más empleado. Se observó significación entre un antes y después al emplear las escalas de WOMET y KOOS abreviada. Conclusiones: la meniscectomía artroscópica es un procedimiento quirúrgico efectivo en pacientes con lesiones de menisco, tanto de causa degenerativa como traumática.

Background: meniscal lesions of the knee due to degenerative and traumatic causes are common. Patients usually complain of mechanical symptoms and signs. Treatment is usually surgical by arthroscopy because of several advantages. Objective: the aim of this study was to evaluate the use of arthroscopic meniscectomy in patients with meniscal lesions. Methods: a quasi experimental study before and after modality with a level of evidence III and recommendation grade B in Manuel Ascunce Domenech hospital in Camaguey city from February 2013 to January 2017 was performed in 158 patients diagnosed with meniscal lesions, but 100 of them were selected as a non-probabilistic sample, based on selected criteria. Results: average age was 46,95 years. Female sex, right knee and medial meniscus prevailed. Degenerative tears were detected in 50 % of the cases. Synovial plica and cartilage lesions were found in 41 and 78 patients respectively. Joint line tenderness and McMurray test were positive in a huge number of patients. Partial arthroscopic meniscectomy was the common used surgical procedure. There were significant statistical differences between before and after while using WOMET and short KOOS scales. Conclusions: arthroscopic meniscectomy is an effective surgical procedure in patients with meniscal lesions.

Effect of pulsed electromagnetic field on the consolidation of posterolateral arthrodeses in the lumbosacral spine: a prospective, double-blind, randomized study / Efeito do campo eletromagnético pulsado na consolidação das artrodeses posterolaterais lombossacras: estudo prospectivo, duplo-cego e randomizado / Efecto del campo electromagnético pulsado en la consolidación de artrodesis posterolaterales en la columna lumbosacral: estudio prospectivo, doble ciego, randomizado

ABSTRACT Objective: To assess the effect of pulsed electromagnetic field (PEMF) on the consolidation of instrumented lumbar posterolateral arthrodeses in patients who have been surgically treated for degenerative spine disease. Methods: Forty cases were recruited from 163 consecutive patients undergoing lumbar arthrodesis at the same center. The patients were randomized into two groups of 20 patients: Active Group, who were exposed to PEMF for 4 hours a day for 90 days after surgery, and Inactive Group, who received an identical device, with the same instructions for use but without the ability to generate PEMF. The patients underwent computed tomography scans at 45, 90, 180 and 360 days after surgery to check for the occurrence of arthrodesis at each operated spinal level. Results: In the course of the study, two patients were excluded from each group. There were no significant differences between the groups with respect to age, gender, smoking habit, or the number of vertebral levels included in the arthrodesis. The percentage of consolidation of the vertebral levels increased at 90, 180 and 360 days compared to 45 days (p<0.001) in both groups. The Active Group had a 276% greater chance of consolidation in the vertebral levels (OR = 3.76; 95% CI: 1.39-10.20), regardless of the time of evaluation. Patients in the Active Group presented 16% more consolidation than patients in the inactive group (p=0.018). Conclusions: Post-operative exposure to PEMF following instrumented arthrodesis of the lumbar spine for degenerative spine disease increased consolidation in the first year after surgery.

RESUMO Objetivo: Avaliar o efeito do campo eletromagnético pulsado (CEMP) na consolidação de artrodeses posterolaterais lombares instrumentadas em pacientes que foram tratados cirurgicamente de doença degenerativa da coluna vertebral. Métodos: Quarenta casos foram recrutados de 163 pacientes consecutivos submetidos à artrodese lombar no mesmo centro. Os pacientes foram randomizados em dois grupos de 20 pacientes: Grupo Ativo, que foi exposto a CEMP por 4 horas por dia durante 90 dias após a cirurgia e Grupo Inativo, que recebeu um dispositivo idêntico, com as mesmas instruções de uso, mas sem a capacidade de gerar CEMP. Os pacientes foram submetidos a exames de tomografia computadorizada aos 45, 90, 180 e 360 dias após a cirurgia para verificar a ocorrência de artrodese em cada nível espinhal operado. Resultados: No decorrer do estudo, dois pacientes foram excluídos de cada grupo. Não houve diferenças significativas entre os grupos com relação à idade, sexo, tabagismo ou número de níveis vertebrais incluídos na artrodese. A percentagem de consolidação dos níveis vertebrais aumentou aos 90, 180 e 360 dias em comparação com 45 dias (p < 0,001) em ambos os grupos. O Grupo Ativo teve uma chance de consolidação 276% maior nos níveis vertebrais (OR = 3,76; IC 95%: 1,39-10,20), independentemente do momento da avaliação. Os pacientes do Grupo Ativo apresentaram 16% mais consolidação do que os pacientes no grupo inativo (p = 0,018). Conclusões: A exposição pós-operatória ao CEMP após artrodese instrumentada da coluna lombar na doença degenerativa da coluna vertebral aumentou a consolidação no primeiro ano após a cirurgia.

RESUMEN Objetivo: Evaluar el efecto del campo electromagnético pulsado (CEMP) en la consolidación de la artrodesis posterolateral lumbar instrumentada en pacientes tratados quirúrgicamente por enfermedad degenerativa de la columna vertebral. Métodos: Cuarenta casos fueron reclutados de 163 pacientes consecutivos sometidos a artrodesis lumbar en el mismo centro. Los pacientes fueron asignados al azar a dos grupos de 20 pacientes: Grupo Activo, que fue expuesto a CEMP durante 4 horas al día durante 90 días después de la cirugía y Grupo Inactivo, que recibió un dispositivo idéntico, con las mismas instrucciones de uso pero sin la capacidad de generar CEMP. Los pacientes fueron sometidos a tomografía computarizada a los 45, 90, 180 y 360 días después de la cirugía para comprobar la presencia de artrodesis en cada nivel operado de la columna. Resultados: En el curso del estudio, dos pacientes fueron excluidos de cada grupo. No hubo diferencias significativas entre los grupos con respecto a la edad, el sexo, el tabaquismo o el número de niveles vertebrales incluidos en la artrodesis. El porcentaje de consolidación de los niveles vertebrales aumentó a los 90, 180 y 360 días en comparación con 45 días (p < 0,001) en ambos grupos. El Grupo Activo tenía una probabilidad 276% mayor de consolidación en los niveles vertebrales (OR = 3,76; IC del 95%: 1,39-10,20), independientemente del momento de la evaluación. Los pacientes del Grupo Activo presentaron 16% más de consolidación que los pacientes del Grupo Inactivo (p = 0,018). Conclusiones: La exposición postoperatoria a CEMP después de la artrodesis instrumentada de la columna lumbar en la enfermedad degenerativa de la columna vertebral aumentó la consolidación en el primer año después de la cirugía.