Ensayos aleatorizados publicados por instituciones ubicadas en Perú: estudio bibliométrico del periodo 2000 a 2022

Objetivo: Caracterizar la producción científica de ensayos aleatorizados por instituciones ubicadas en Perú del 01 de enero de 2000 al 30 de diciembre de 2022. Materiales y Métodos: Estudio bibliométrico, se revisaron dos bases de datos (MEDLINE y SciELO). Se incluyeron artículos originales en la que al menos un autor consignó como filiación una institución ubicada en Perú. Se caracterizó la producción científica según: área temática, participación de instituciones ubicadas en Perú, revistas científicas en las que se publicaron los artículos, y aprobación de los estudios por un Comité de Ética en Investigación (CEI). Resultados: Se analizó un total de 402 artículos, se evidenció una tendencia creciente de la producción científica, pasando de seis en el año 2000 a 39 en el año 2021, el área temática predominante es la infecciosa, las dos primeras instituciones con mayor número de ensayos aleatorizados pertenecen al sector educación, 189 (47,0%) artículos fueron publicados en revistas de Estados Unidos, en 37 (9,2%) artículos no se consigna información de aspectos éticos o no se declara explícitamente si fue o no aprobado por un CEI. Conclusión: Hay una tendencia creciente de la producción científica sobre este diseño de estudio, el área temática predominante es la infecciosa, las instituciones peruanas más productivas pertenecen al sector educación, cerca de la mitad de los artículos fueron publicados en revistas de Estados Unidos, y en una décima parte de los artículos no se señala explícitamente si el estudio fue o no aprobado por un CEI.

Objetive: To characterize the scientific production of randomized trials by institutions located in Peru from January 1, 2000 to December 30, 2022. Materials and methods: Bibliometric study, two databases (MEDLINE and SciELO) were reviewed. Original articles were included in which at least one author stated an institution located in Peru as affiliation. Scientific production was characterized according to: thematic area, participation of institutions located in Peru, scientific journals in which the articles were published, and approval of the studies by a Research Ethics Committee (REC). Results: A total of 402 articles were analyzed, a growing trend in scientific production was evidenced, going from six in the year 2000 to 39 in the year 2021, the predominant thematic area is infectious, the first two institutions with the highest number of randomized trials belong to the education sector, 189 (47.0%) articles were published in journals in the United States, in 37 (9.2%) articles there is no information on ethical aspects or it is not explicitly stated whether or not it was approved by a CEI. Conclusions: There is a growing trend of scientific production on this study design, the predominant thematic area is infectious, the most productive Peruvian institutions belong to the education sector, about half of the articles were published in journals in the United States, and in a tenth part of the articles do not explicitly state whether or not the study was approved by an REC.

Subcutaneous terbutaline and oral nifedipine for intrapartum fetal resuscitation: a prospective randomized controlled study / 中华围产医学杂志

Objective:To compare the safety and efficacy of terbutaline and nifedipine for acute intrapartum fetal resuscitation (IUFR).Methods:This was a prospective randomized controlled study involving 110 pregnant women with non-reassuring fetal heart rate tracings (NRFHT) during delivery at Guangzhou Women and Children's Medical Center between January and April 2021. These women were randomly allocated to receive subcutaneous terbutaline sulphate (0.25 mg, terbutaline group) or oral nifedipine (10 mg, nifedipine group), with 55 subjects in each group. Hemodynamic parameters including blood pressure, heart rate, and oxygen saturation before and 5, 15 and 30 min after treatment as well as the success rate of intrapartum resuscitation, the onset time of medication, and the incidence of postpartum hemorrhage were analyzed using t test, Chi-square test or Fisher's exact test. Results:Two groups both showed no significant difference in the mean arterial pressure or oxygen saturation before or after treatment (all P>0.05). The heart rate was not affected in nifedipine group at any time points ( P>0.05). While the patients treated with terbutaline showed accelerated maternal heart rate 5, 15 and 30 min after administration as compared with the baseline[(97.0±20.2), (99.2±13.8), (91.8±12.6) vs (81.7±11.3) bpm, all P<0.001], but it began to decrease at 30 min, with a drop of 6.4 bpm compared with that at 15 min (95% CI: 1.5-11.2, P<0.05). None of the pregnant women had adverse reactions requiring medical intervention. The rates of successful acute resuscitation were similar in the two groups [terbutaline: 78.2% (43/55) vs nifedipine: 70.9% (39/55), χ 2= 0.77, P=0.381]. Terbutaline had a shorter onset time than nifedipine in slowing the frequency of contractions and returning fetal heart rate to class Ⅰ category [2(1-6) vs 6(1-10) min, U=2 348.50, P<0.001]. No significant difference was found between the two groups in terms of NRFHT-indicated cesarean section, assisted vaginal delivery, or second dose of tocolysis within 1 h (all P>0.05) nor in blood loss volume, postpartum hemorrhage rate, low Apgar score, low umbilical artery pH value (pH<7.2), neonatal asphyxia rate, or neonatal intensive care admission rate (all P>0.05). Conclusion:Terbutaline spends less time than nifedipine to take effect and may be an alternative for acute IUFR without significant adverse outcomes.

Comparación de dos estrategias educacionales para la enseñanza del procedimiento de manejo de vía aérea en programas de práctica deliberada aplicados a estudiantes de medicina: ensayo randomizado

Background: Clinical simulation allows the acquisition of procedural skills among medical students. The anticipatory study of these skills may improve the efficiency of simulation sessions. Aim: To Compare two anticipatory study guides in the simulation of airway management, in a cohort of medical students from Chile. Material and Methods: Fifth year medical students were randomly assigned to prepare the simulation of tracheal intubation with a theoretical guide, an audiovisual guide, and a control group without study. The skills acquired were evaluated in a simulated scenario. Results: All groups increased their successful orotracheal intubation (OTI) rate and decreased the time to achieve a successful OTI after each attempt. The study group with a theoretical guide had the higher rate of success in the 1st OTI attempt without feedback. In contrast, the group without any anticipatory study had more failed attempts (1st and 2nd attempt), achieving their first successful OTI in the 3rd attempt after feedback. Conclusions: Study guides improve practice effectiveness. Our results indicate that the best results are obtained by simulation accompanied with immediate directed feedback and opportunities to repeat the procedures, independent of the type of anticipatory study.

Risk factors of urinary incontinence in Chinese women based on random forest / 中华妇产科杂志

Objective:To explore the risk factors of urinary incontinence (UI) in China by using random forest algorithm, and to evaluate the predictive effect of each risk factor on UI.Methods:A baseline survey with a multistage stratified cluster sampling design was conducted between February 2014 and January 2016, and followed up by telephone from June to December 2018. A total of 55 477 adult women from six provinces of China participated the survey. According to the ratio of 1:1, under sampling method was used to randomly select the same number of women as UI from the non UI women. The data were randomly divided into training set and verification set according to 7:3. The training set was used to establish the random forest model, which including the candidate variables with P<0.2 in univariate analysis, and the verification set was used to verify the predictive effects. Results:A total of 30 658 patients (55.26%, 30 658/55 477) completed the follow-up, the median follow-up time was 3.7 years. Among the 24 985 women without UI at baseline, 1 757 (7.03%, 1 757/24 985) had UI at followed up, including 1 117 (4.47%, 1 117/24 985) with stress UI, 243 (0.97%, 243/24 985) with urgency UI and 397 (1.59%, 397/24 985) with mixed UI. When fixed the number of features as 2 and the number of random trees as 300 in the random forest model, the out of bag error rate estimation was the lowest; with such parameter settings, the classification accuracy was 64.3%, the sensitivity was 64.2%, and the specificity was 64.4%. The top10 predictive UI factors that screening by the variable importance measure in random forest model were obtained as follows: age, parity, delivery pattern, body mass index (BMI), menopause, history of diabetes, education level, history of pelvic surgery, regions, and marital status.Conclusion:We identified the top10 predictive UI factors that screening by the variable importance in random forest model as follows: age, parity, delivery pattern, BMI, menopause, history of diabetes, education level, history of pelvic surgery, regions, and marital status.

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.

Randomization in clinical studies / 대한마취과학회지

Randomized controlled trial is widely accepted as the best design for evaluating the efficacy of a new treatment because of the advantages of randomization (random allocation). Randomization eliminates accidental bias, including selection bias, and provides a base for allowing the use of probability theory. Despite its importance, randomization has not been properly understood. This article introduces the different randomization methods with examples: simple randomization; block randomization; adaptive randomization, including minimization; and response-adaptive randomization. Ethics related to randomization are also discussed. The study is helpful in understanding the basic concepts of randomization and how to use R software.

Random allocation and dynamic allocation randomization

Random allocation is commonly used in medical researches, and has become an essential part of designing clinical trials. It produces comparable groups with regard to known or unknown prognostic factors, and prevents the selection bias which occurs due to the arbitrary assignment of subjects to groups. It also provides the background for statistical testing. Depending on the change in allocation probability, random allocation is divided into two categories: fixed allocation randomization and dynamic allocation randomization. In this paper, the author briefly introduces both the theory and practice of randomization. The definition, necessity, principal, significance, and classification of randomization are also explained. Advantages and disadvantages of each randomization technique are further discussed. Dynamic allocation randomization (Adaptive randomization), which is as yet unfamiliar with the anesthesiologist, is also introduced. Lastly, the methods and procedures for random sequence generation using Microsoft Excel is provided.

Random allocation and dynamic allocation randomization

Random allocation is commonly used in medical researches, and has become an essential part of designing clinical trials. It produces comparable groups with regard to known or unknown prognostic factors, and prevents the selection bias which occurs due to the arbitrary assignment of subjects to groups. It also provides the background for statistical testing. Depending on the change in allocation probability, random allocation is divided into two categories: fixed allocation randomization and dynamic allocation randomization. In this paper, the author briefly introduces both the theory and practice of randomization. The definition, necessity, principal, significance, and classification of randomization are also explained. Advantages and disadvantages of each randomization technique are further discussed. Dynamic allocation randomization (Adaptive randomization), which is as yet unfamiliar with the anesthesiologist, is also introduced. Lastly, the methods and procedures for random sequence generation using Microsoft Excel is provided.

Using random allocation book for random allocation concealment in a clinical trial / 医学研究生学报

Objective Random allocation concealment is important in ensuring high-guality randomized controlled clinical trial.In this paper , we aimed to design a more convenient and effective two couplet random allocation method through improving the random allocation concealment technology which uses the envelope method . Methods According to the randomized sequence , a two-couplet random allocation should be prepared for every subject and bound into a book in order , which named random assignment book with cover and instructions .The first couplet is to collect the enroll information and the second couplet is to show the allocation informa -tion.The serial numbers of the two couplets which around sealant are the same , and leave blank at the same areas of the two couplets for signing the enter information .The content of the first couplet can be completely copied to the second couplet .In order to avoid expo-sing the allocation information in advance , the back of the second couplet should be black-printed. When the subjects are sure qualified, the researchers selected the corresponding two couplet in a sequential order .Exposing the allocation infromation in the second couplet, and the subjects will be allocated to the group designated on the second couplet .This random allocation book should be entrusted to professional printing mechanism ,printing according to the random assignment sequence table and in the strict quality control .For the multicenter clinical trials , it can be printed in parts . Results The method has been implemented in nearly ten randomized controlled trials and obtained the consistent high praise . Conclusion The random allocation book method is easy to produce , simple operation and convenient in monitoring , which can effectively achieve the random allocation concealment in a clinical trial as well as having a sig -nificantly practical value in ensuring the quality of randomization .

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.

Estudios experimentales 2 parte: estudios cuasi-experimentales / Experimental studies 2nd part: quasi-experimental studies

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 datos y seguimiento. Agrupados bajo esta denominación, existe una diversidad de diseños, entre los que se encuentran los estudios cuasi-experimentales (ECE), que se caracterizan especialmente por la ausencia de asignación aleatoria. El objetivo de este manuscrito, es reportar los principios básicos, tipos, características y estrategias para la conducción de ECE.

Experimental studies are characterized by assessing the effect of one or more interventions, usually comparatively with other intervention, or placebo; and the prospective nature of data collection and follow-up. Clustered under this denomination, a variety of designs, among which are the quasi-experimental studies (QES), which are characterized particularly by the absence of randomization. The aim of this manuscript is to report the basic principles, types, characteristics and strategies for conducting QES.

Consideraciones bioéticas en estudios experimentales de evaluación de impacto de programas / Bioethical considerations regarding experimental studies for evaluating programme impact

Todo tipo de estudio con intervención en personas requiere consideraciones éticas. Los estudios de evaluación de programas que utilizan diseños aleatorizados requieren consideraciones importantes en sus fases de selección, asignación de la intervención y seguimiento a través del tiempo. En la fase de selección es necesario un especial enfoque hacia la equidad en el proceso de inclusión de los sujetos como participantes de los estudios, el consentimiento informado y la confidencialidad desde el inicio del estudio. En la fase de asignación de la intervención es necesario tener en cuenta la privación de beneficios de los programas en el grupo que sirve como control, la asignación de los beneficios por sorteo y la justicia en la asignación de las intervenciones. En la fase de seguimiento, es relevante considerar los resultados adversos de las intervenciones y las retribuciones que requieren los participantes del estudio. Las implicaciones éticas de la aleatorización de individuos beneficiarios de programas requieren amplio análisis y organización de procesos de consenso, así como la divulgación de guías de lineamientos éticos para investigadores y evaluadores.

Ethical considerations must be taken into account in studies involving people. The evaluation of programmes using randomised designs requires careful consideration regarding their enrolment, intervention allocation and follow/up phases. From the outset, special emphasis must be placed on equity during the enrolment phase concerning the inclusion of subjects participating in such studies, gaining/giving their informed consent and confidentiality. The allocation intervention phase should consider the control group's deprivation of benefits, their assignation by random draw and equity regarding the distribution of benefits. Special consideration should be paid to adverse events during the follow-up phase and participants' remuneration. The ethical implications of randomising individuals benefitting from programmes require extensive analysis, the organisation of consensus and ethical guidelines being disseminated for researchers and evaluators.

Impacto da solução de Carnoy no número de linfonodos resgatados em peças cirúrgicas de câncer gástrico: estudo prospectivo randomizado

Introdução: O adenocarcinoma gástrico é uma doença de elevada incidência e alta mortalidade. A gastrectomia com linfadenectomia é tratamento potencialmente curativo, promovendo controle loco - regional da doença e fornecendo material para análise histopatológica. Para o adequado estadiamento dos pacientes é recomendado que pelo menos 16 linfonodos seja m examinados pela patologia, entretanto, espera - se maior sobrevida quando ≥ 30 linfonodos são avaliados , mesmo em pacientes com tumores precoce s. A justificativa para este achado é o sub - estadiamento de pacientes com poucos linfonodos examina dos. Linfonodos pequenos são particularmente difíceis de serem encontrados, mas podem conter metástases e impactar negativamente na sobrevida. Visando facilitar sua identificação, soluções clareadoras de gordura foram propostas, entretanto não há evidência clara de seu benefício clínico. Objetivos: Comparar as soluções de Carnoy e de formalina neutra tamponada em relação ao número absoluto de linfonodos encontrados na peça cirúrgica de pacientes submetidos a gastrectomia. Averiguar se linfonodos retirados cirurgicamente são perdidos com a fixação em formalina e, caso isso ocorra, se este fato é relevante para o estadiamento. Observar se o protocolo de pesquisa influenciou o número de linfonodos encontrados. Métodos: Cinquenta produtos de gastrectomia subtotal com linfadenectomia D2 por adenocarcinoma gástrico foram randomizados para fixação em Carnoy ou formalina com posterior dissecção da peça em b usca de linfonodos. Após a dissecção do grupo Formalinn, a gordura residual a ser desprezada foi imersa em Carnoy e reavaliada posteriormente. Os dados de 25 gastrectomias D2 operad a s previamente ao estudo também foram avalia do s. Resultados: A média de linfonodos encontrados nos grupos C arnoy e Formalina foi de 50,4 e 34,8; respectivamente (p <0,001)...

Background: Gastric adenocarcinoma is a frequent disease with high mortality ratio. Gastrectomy with lymphadenectomy is potentially curative, allows local control of the disease and provides material for TNM classification. While pathology examination of at least 16 lymph nodes is recommended following surgery, longer survival rates are expected when >=30 lymph nodes are examined, even for early gastric cancer. The understaging of patients with less examined lymph nodes justifies this findings. Small lymph nodes are particularly difficult to identify and fat clearing solutions have been proposed to improve this, but there is no evidence of their clinical benefit. Objectives: Compare Carnoy's solution (CS) and formalin in terms of the total number of examined lymph nodes following gastrectomy. Verify if surgically retrieved lymph nodes are lost with the formalin fixation and if this fact is clinically significant. Observe if a research protocol influences the number of examined lymph nodes. Methods: Fifty specimens of gastrectomy with D2 lymphadenectomy were randomized for fixation in CS or formalin with posterior dissection in search for lymph nodes. In the Formalin group, the residual fat to be discarded was immersed in CS and dissected again. Data from 25 D2 gastrectomies performed previously the present study were retrospectively analyzed. Results: The medium number of examined lymph nodes was 50.4 and 34.8 for CS and formalin, respectively (p < 0.001). Lost lymph nodes were found in all cases in the Residual Fat group (medium 16.9), this increased the Formalin group average to 51.7 (which is similar to the CS group, p=0.809). With one exception (7mm), all other examined lymph nodes in the Residual Fat group measured <= 3mm. Thirteen lymph nodes from this group were metastatic, this determined the upstaging of 2 (8%) patients. Lymph nodes from the CS group were smaller than those found in the formalin group (p=0.01)...

How to Do Random Allocation (Randomization)

PURPOSE: To explain the concept and procedure of random allocation as used in a randomized controlled study. METHODS: We explain the general concept of random allocation and demonstrate how to perform the procedure easily and how to report it in a paper.

Diferencias entre las características basales de los pacientes en los ensayos clínicos, según el tamaño de la muestra. Un estudio metaepidemiológico / Differences between baseline characteristics of patients in a RCT by sample size. meta-epidemiological study

Objetivo: determinar las diferencias en las variables cualitativas y cuantitativas de las características basales de los ensayos clínicos controlados con asignación aleatoria, según su tamaño de muestra. Metodología: estudio observacional, transversal que incluyó los ensayos clínicos con asignación aleatoria publicados en cuatro revistas médicas generales de alto factor de impacto. Según su tamaño de muestra, se dividieron en cinco estratos y se evaluó la diferencia entre variables cualitativas y cuantitativas de las características basales. Resultados: se analizaron 1000 variables de los pacientes que participaron en ensayos clínicos. Cuando se comparó cada uno de los grupos por tamaño de muestra con respecto al de ≥5000 pacientes, se encontró que las diferencias de medias disminuían a medida que los tamaños de muestra tenían mayor número de pacientes. Conclusiones: la diferencia de resultados de las características basales de los ensayos clínicos, es inversamente proporcional al tamaño de muestra y, por encima de 500 pacientes por grupo, las diferencias promedio serían menores al 1.2%.

Objective: To determine the differences in qualitative and quantitative variables in the baseline characteristics of the controlled clinical trials randomized by sample size. Methods: Observational, cross-sectional study including randomized clinical trials published in four high impact factor general medical journals. They were divided into five strata according to sample size; the differences between qualitative and quantitative variables of baseline characteristics were evaluated. Results: One thousand variables of patients participating in clinical trials were analyzed. By comparing each of the groups according to sample size with respect to the group of ≥ 5000 patients, it was determined that the mean differences decreased as the sample sizes included a greater number of patients. Conclusions: The differences in results of the baseline characteristics of clinical trials are inversely proportional to the sample size, and the average differences in groups above 500 patients would be less than 1.2%.

Objetivo: Determinar as diferenças nas variáveis qualitativas e quantitativas das características basais dos ensaios clínicos controlados com atribuição aleatória segundo seu tamanho de mostra. Metodologia: Estudo observacional, cross sectional que incluiu os ensaios clínicos com atribuição aleatória publicados em quatro revistas médicas generais de alto fator de impacto. Segundo o de tamanho de mostra deles, dividiram-se em cinco estratos, avaliou-se a diferença entre variáveis qualitativas e quantitativas das características basais. Resultados: Analisaram-se 1000 variáveis dos pacientes que participaram em ensaios clínicos. Ao comparar cada um dos grupos por tamanho de mostra com respeito ao de ≥5000 pacientes se encontrou que as diferenças de médias diminuíam à medida que os tamanhos de mostra tinham maior número de pacientes. Conclusões: A diferença de resultados das características basais dos ensaios clínicos, é inversamente proporcional ao tamanho de mostra e acima de 500 pacientes por grupo as diferencias média seriam menores a 1.2%.

Efeitos do estímulo verbal sobre o desempenho no teste de escada e ajustes cardiorrespiratórios em sujeitos saudáveis / The effects of verbal stimulus on performance in stair climbing test and cardiorespiratory adjustments in healthy subjects

Esta pesquisa teve o objetivo de avaliar os efeitos do estímulo verbal (EV) no tempo do teste de escada (TEsc) e nas variáveis cardiorrespiratórias de adultos saudáveis. Trinta e um adultos saudáveis realizaram dois TEsc (com EV e sem EV). Antes e depois de cada teste, foram avaliados os sinais vitais e a Escala de Borg. Os tempos nos TEsc foram comparados por meio do Teste t de Student para amostras pareadas e as diferenças, de acordo com a ordem de realização dos testes utilizando o Teste de Mann-Whitney. Os sinais vitais e a Escala de Borg foram comparados por meio do Teste de Friedman ou ANOVA com post hoc do Teste de Tukey. As variações foram comparadas utilizando o Teste t Student para amostras independentes ou Teste de Mann-Whitney (p<0,05). O tempo no TEsc sem EV foi de 23,48±8,28 segundos, significativamente maior que o teste com EV, que foi de 21,60±7,18 segundos (p<0,05). Todas as variáveis aumentaram após os testes, e a Escala de Borg foi a única que teve maior variação no TEsc com EV, variando 2,5±1,4 no teste sem estímulo e 3,0±1,8 pontos no com estímulo (p<0,05). O estímulo verbal melhora o desempenho no TEsc e leva à maior sensação de esforço.

This research aimed to evaluate the effects of verbal stimuli (VS) in the time of the Stair climbing Test (SCT) and in the cardiorespiratory variables on healthy adults. Thirty-one healthy adults performed two SCT (with VS and without VS). Before and after each test, vital signs and Borg Scale were evaluated. The times in SCT were compared using the Student's t-test for paired samples, and differences were compared according to the order of the testing using the Mann-Whitney Test. The vital signs and Borg Scale were compared by the Friedman Test or ANOVA with post-hoc Tukey Test. The variations of these variables were compared using the Student's t-test for independent samples or Mann-Whitney Test (p<0.05). The time in the SCT without VS was 23.48±8.28 seconds significantly greater than the test with VS that was 21.60±7.18 seconds (p<0.05). All the variables increased after the tests and the Borg Scale was the one that had more variation in SCT with VS, ranging 2.5±1.4 in the test without VS and 3.0±1.8 points in the test with VS (p<0.05). Verbal stimulation improves performance in TEsc and leads to greater sensation of effort.

Quality Assessment of Randomized Controlled Trials Published in the Korean Journal of Urology Over the Past 20 Years

PURPOSE: Because low-quality trials may lead to erroneous conclusions, quality assessments are necessary. Thus, in this study, we scrutinized randomized controlled trials (RCTs) published in the Korean Journal of Urology (KJU) to assess their quantity and quality. MATERIALS AND METHODS: Upon extracting RCTs from all articles published in the KJU from 1991 to 2010, assessments were made on the basis of the Jadad scale and the adequacy of allocation concealment. The selections and assessments were performed independently by two researchers, and adjustment of the differences was done by a third-party researcher. In addition, the factors that may affect quality were analyzed. RESULTS: A total of 3,516 original articles were searched and 28 RCTs were extracted. In the 1990s, RCTs constituted only 0.27% of the total original articles, but in the 2000s, RCTs constituted 1.34%. The mean total Jadad score increased from 1.6 points in the 1990s to 1.65 points in the 2000s. However, the percentage of "good quality" trials also increased from 20% to 30.43%. As for adequate allocation concealment, one study was observed in the 2000s. The aspect most lacking was appropriate dropout and double-blinding. Studies with medical interventions or funded or examined by institutional review boards tended to receive higher quality assessments. CONCLUSIONS: Although RCTs consistently increased in both quantity and quality, in future studies, researchers should continue to strive toward achieving adequate allocation concealment and appropriate double-blinding. In addition, researchers must become more interested in receiving external funding and undergoing examination by institutional review boards.

New quantitative variables to measure postoperative pericardial adhesions: useful tools in experimental research / Novas variáveis quantitativas para avaliação das aderências pericárdicas: ferramentas úteis na pesquisa experimental

PURPOSE: To improve the measurement system, during a research for the prevention of adhesions, we explored the feasibility of introducing three continuous numeric variables to quantify the intensity of pericardial adhesions. METHODS: To validate these three new numeric variables - time spent to dissect the adhesions (Δt), the amount of sharp dissection (ShpD) and the adhesion's collagen area (ACA) - as useful tools in measuring the severity of pericardial adhesions, data from a randomized study on adhesion prevention enrolling twenty-four swine, were analysed. A statistical Spearman's test and regressions models were applied to verify the correlation and the relationship between the results of a standard severity score (SS) and Δt, between SS and ShpD used in adhesiolysis and, also, between SS and ACA. RESULTS: There was a statistically significant correlation between SS and Δt, between SS and ShpD, as well as between SS and ACA, all measured by the Spearman's test (r=0.897, r=0.932, r=0.66; p<0.01, respectively). Through a non-linear regression, an exponential relation of SS with ShpD (R²=0.915) and SS with Δt (R²= 0.917) was found. CONCLUSION: The time spent to dissect the adhesions (Δt) and the amount of sharp dissection (ShpD) are new powerful measurement tools in evaluating outcomes of the methods used to prevent pericardial adhesions.

OBJETIVO: A fim de melhorar a metodologia de mensuração das aderências pericárdicas, avaliamos, durante um estudo de prevenção de aderências pericárdicas, a possibilidade da utilização de três de novas variáveis contínuas e numéricas. MÉTODOS: Para validar estas novas variáveis numéricas - tempo de dissecção (Δt), quantidade de dissecção cruenta (ShpD) e a área de colágeno na aderência (ACA) como instrumentos precisos na quantificação das aderências pericárdicas, foram analisados os dados de um estudo para prevenção de aderências que envolveu 24 porcos. Foram aplicados modelos de regressão e o teste de Spearman para avaliar a força e os tipos correlações entre os resultados do escore padrão de classificação de aderências (SS) e o Δt, entre o SS e o ShpD, e, também, entre o SS e a ACA. RESULTADOS: Foram evidenciadas correlações, estatisticamente significativas, entre o SS e o Δt, entre o SS e o ShpD, também como entre o SS e a ACA avaliadas através do teste de Spearman (r=0,897, r=0,932 , r=0,66; p<0,001, respectivamente). Identificou-se, através de regreção não-linear, uma relação exponencial do SS com o ShpD (R²=0,915) e com o Δt (R²= 0,917). CONCLUSÃO: Este estudo mostrou que o Δt e o ShpD são variáveis poderosas para avaliar os resultados dos métodos utilizados para prevenção das aderências pericárdicas.

Clinical and quality-of-life outcomes after autologous fascial sling and tension-free vaginal tape: a prospective randomized trial

Purpose: Evaluate the impact autologous fascial sling (AFS) and tension-free vaginal tape (TVT) procedures on quality-of-life in incontinent women. Materials and Methods: Forty-one women were randomly distributed into two groups. Group G1 (n = 21), underwent AFS and group G2 (n = 20) TVT implant. The clinical follow up was performed at 1, 6, 12 and 36 months. Results: TVT operative time was significantly shorter than AFS. Cure rates were 71 percent at 1 month, 57 percent at 6 and 12 months in G1. In G2, cure rates were 75 percent at 1 month, 70 percent at 6 months and 65 percent at 12 months; there was no significant difference between groups. As regards the satisfaction rate, there was no statistical difference between groups. Analysis of quality of life at 36 months revealed that there was no significant difference between groups. Conclusion: Similar results between AFS and TVT, except for operative time were shorter in TVT.

The Quality of Reporting of Randomized Controlled Trials in Korean Medical Journals Indexed in KoreaMed: Survey of Items of the Revised CONSORT Statement

BACKGROUND: The revised Consolidated Standards for Reporting of Trials (CONSORT) were developed to improve the reporting of Randomized Controlled Trials. We studied to survey the extent to which RCTs report items included in the revised CONSORT recommendations. METHODS: A descriptive survey of RCTs enrolled in 2005 at KoreaMed, which is a representative database in Korea was done. The main outcome measures were the proportion of RCTs that reported each of 22 checklist items of CONSORT. RESULTS: We identified 125 RCTs from 26 journals. Random sequence implementation (0%), estimated effect size and its precision (0%), sample size determination (8.9%), method of random sequence generation (7.3%), allocation concealment (3.2%), participant flow (4.8%) and any other analysis (7.3%), generalizability of the trial findings (0.8%) were pooly reported. CONCLUSION: The proportions of following the CONSORT recommendations in Korean medical journals were very low. An effort to improve the reporting of RCTs by application and recommendation of CONSORT statement is required.