Types of randomized clinical trials published in PubMed over 40 years / Tipos de ensayos clínicos con asignación aleatoria publicados en PubMed durante 40 años

Abstract Introduction: there are several variations of randomized clinical trials. Trials can be classi fied by design as parallel, cross-over, factorial, assignment by group, n-of-1, paired, withdrawal, adaptive and pragmatic; and by purpose as superiority, non-inferiority and equivalence. Given this heterogeneity, the Consolidated Standards of Reporting Trials (CONSORT) were introduced in 1996 to provide a guideline for reporting randomized clinical trials. Objective: to describe the publication tendency of the various types of randomized clinical trials over 40 years, with reference to the publication of CONSORT and its extensions. Methods: the PubMed tool was used to search for randomized clinical trials published between 1979 and 2018, classifying them according to the varieties described. Results: a total of 472,114 published articles were found; 90.2% did not report the type of design and 98.2% did not report the purpose. Among the articles that reported the variety of randomized clinical trial, the predominant design was cross-over (5.9%), followed by parallel groups (2.34%); while the most common purpose was superiority (0.84%). After the launch of CONSORT, there was an increased proportion of articles published with the following designs: parallel groups; difference in proportions 1.89 95% CI (1.1-2.7); paired 1.07 95% CI (0.2-1.9); and pragmatic 4.73 95% CI (4.4-5.1); and for the purpose of non-inferiority 5.97 95% CI (5.6-6.3). Discussion: most articles on randomized clinical trials do not mention their type in the title and abstract. The proportion of articles that did, increased slightly after CONSORT was published. (Acta Med Colomb 2021; 46. DOI:https://doi.org/10.36104/amc.2021.1884).

Resumen Introducción: existen múltiples variantes del ensayo clínico aleatorizado; según diseño: grupos paralelos, cruzado, factorial, asignación por grupos, N de 1, pareado, retiro, adaptativo y pragmático; y por propósito: superioridad, no inferioridad y equivalencia. Debido a esta heterogeneidad, en 1996 se introdujo el CONSORT (Consolidated Standards of Reporting Trials) para suministrar una guía para el reporte de los ensayos clínicos aleatorizados. Objetivo: describir la tendencia de publicación de los tipos de ensayos clínicos aleatorizados durante 40 años, en relación con la publicación del CONSORT y sus extensiones. Métodos: se utilizó la herramienta PubMed para realizar una búsqueda de ensayos clínicos aleatorizados publicados entre 1979 y 2018, discriminándolos según las variantes descritas. Resultados: se encontraron 472 114 artículos publicados, el 90.2% no reportó tipo de diseño y 98.2% no reportó propósito. Entre los artículos que reportaron la variante de ensayos clínicos aleatorizados, el diseño predominante fue el cruzado (5.9%), seguido por grupos paralelos (2.34%); mientras que el propósito más frecuente fue el de superioridad (0.84%). Hubo un aumento en la proporción de artículos por variante publicados después del lanzamiento del CONSORT para los diseños de: grupos paralelos; diferencia de proporciones 1.89 IC 95% (1.1-2.7); pareado 1.07 IC 95% (0.2-1.9); pragmático 4.73 IC 95% (4.4-5.1); y para el propósito de no inferioridad 5.97 IC 95% (5.6-6.3). Discusión: la mayoría de los artículos sobre ensayos clínicos aleatorizados no mencionan en su título y resumen la variante de estos. La proporción de artículos que sí lo hicieron, aumentó discre tamente después de la publicación del CONSORT. (Acta Med Colomb 2021; 46. DOI:https://doi.org/10.36104/amc.2021.1884).

[Epidemiological characteristics and diagnosis of suspected occupational diseases in Guangzhou from 2006 to 2018].

Objective: To investigate the epidemiological characteristics and late diagnosis of suspected occupational diseases in Guangzhou from 2006 to 2018. Methods: The cases of suspected occupational diseases reported in Guangzhou from January 1, 2006 to December 31, 2018 were collected and followed up to the end of 2018. The cases of suspected occupational diseases were analyzed statistically. Results: A total of 1502 suspected occupational cases were reported in Guangzhou from 2006 to 2018, including suspected occupational otorhinolaryngological and oral diseases (58.59%, 880/1502) , suspected occupational chronic poisoning (25.03%, 376/1502) and suspected occupational pneumoconiosis (11.72%, 176/1502) . The key reporting areas were Huangpu District (27.50%, 413/1502) and Panyu District (20.91%, 314/1502) . The key reporting industries were manufacturing industry (80.36%, 1207/1502) , among which railway, ship, aerospace and other transportation equipment manufacturing industry (13.26%, 160/1207) , automobile manufacturing industry (12.51%, 151/1207) and general equipment manufacturing industry (10.19%, 123/1207) were the main industries. The main type of reported economy was private economy (39.95%, 600/1502) . The scale of the key reporting enterprises was medium and small-sized enterprises (31.09%, 467/1502 and 34.62%, 520/1502) . As of December 31, 2018, 263 cases were diagnosed with occupational diseases, and the diagnosis rate was 17.51%. Conclusion: The number of suspected occupational diseases reported in Guangzhou from 2006 to 2018 is large, and the overall diagnosis rate of suspected occupational diseases is low. It is necessary to strengthen the supervision and management of key diseases, key regions, and key industries of suspected occupational diseases. It is suggested that the reporting system of suspected occupational diseases should be standardized as soon as possible.

Patient Characteristics Following Surgery for Spinal Metastases: A Multicenter Retrospective Study.

OBJECTIVES: To summarize the epidemiological characteristics of patients following surgery for spinal metastases retrospectively and make a univariate analysis to identify independent variables that could affect the operation decision making. METHODS: This was a multicenter retrospective review of patients with spinal metastasis who were treated with surgery from 1 January 2007 to 31 July 2019. Basic clinical data were analyzed retrospectively by univariate analysis to identify independent variables that could affect the decision of operation modalities, including gender, age, spinal metastatic site, Frankel score, Karnofsky performance score (KPS), spinal instability neoplastic score (SINS), visual analogue scale (VAS), Tokuhashi score, urinary and fecal incontinence, spinal pathological fracture, primary tumor, extraspinal metastasis, visceral metastasis, and bone lesion (osteolytic, osteoblastic or mixed). RESULTS: A total of 580 patients including 332 males and 248 females were enrolled in the study with an average age of 58.26 years old (range, 13-86 years old). The most common spinal metastatic level was the thoracic vertebra (190 [32.76%]), followed by the lumbar vertebra (146 [25.17%]), cervical vertebra (47 [8.10%]), and sacral vertebra (35 [6.03%]). Metastases involving more than two sites of the cervical, thoracic, lumbar, and sacral vertebrae arose in 162 (27.93%) patients. For primary tumor, there were 198 (34.14%) cases of lung cancer, 41 (7.07%) cases of kidney cancer, 39 (6.72%) cases of breast cancer, 38 (6.55%) cases of gastrointestinal cancer, 35 (6.03%) cases of lymphoma and myeloma, 25 (4.31%) cases of prostate cancer, 24 (4.14%) cases of liver cancer, 23 (3.97%) cases of mesenchymal tissue sarcoma, 20 (3.45%) cases of thyroid cancer, and 84 (14.48%) cases were tumor with unknown origin. Sixty-three (10.86%) patients received minimally invasive surgery, 460 (79.31%) patients received palliative surgery, and the remaining 57 (9.83%) received tumor resection. According to the univariate analysis, the KPS score, SINS score, VAS score, Tokuhashi score, urinary and fecal incontinence, spinal pathological fracture, and bone lesion (osteolytic, osteoblastic or mixed) were independent and favorable factors affecting the surgery modalities. CONCLUSIONS: Surgical treatment for spinal metastases was mainly to relieve pain, rebuild spinal stability, improve nerve function, control local tumors, and improve the quality of life of patients. For middle-aged and elderly patients with good general conditions, severe pain, spinal pathological fracture, spine instability and without urinary and fecal incontinence, early surgical treatment should be actively carried out.

[Pathogen spectrum in enteroviral infections among children in Beijing from 2010 to 2016].

Objective: To understand the epidemiological and etiological characteristics of enterovirus (EV)-associated diseases among children in Beijing from 2010 to 2016. Methods: This was a repeated cross-sectional study. The throat swabs were collected from children with probable EV-associated diseases at the Children' s Hospital Affiliated to Capital Institute of Pediatrics from 2010 to 2016. The samples were sent for pan-EV, enterovirus 71 (EV-A71) and coxsackievirus A16 (CV-A16) detection by real-time fluorescence reverse transcription polymerase chain reaction (RT-PCR) . The viral types of non-EV-A71 and non-CV-A16 EV-positive samples were identified using modified RT-PCR and sequencing with CV-A6, EV-A/B group and 5 'UTR universal primers. The constituent ratios of the prevalence of different EV types in different age and gender groups were compared. Results: Of the 2 703 throat swabs, 1 992 (73.7%) samples were positive for EV, including EV-A71 (19.1%, 516/2 703), CV-A16 (24.3%, 658/2 703), CV-A6 (22.2%, 600/2 703), CV-A10 (4.5%, 122/2 703) and other types of EV (3.5%, 95/2 703). There was 1 case of EV-A71 and CV-A16 co-infection. The positive detection rate of EV-A group (excluding EV-A71, CV-A16, CV-A6 and CV-A10) increased from 11.3% (7/62) to 95.2% (59/62) after using the modified VP1-specific primers and PCR amplification conditions. During the period between 2010 and 2012, CV-A16 and EV-A71 predominated in EV-positive samples. However, CV-A6 accounted for 60.7% (68/112) in 2013, much higher than CV-A16 (23.2%, 26/112) and EV-A71 (12.5%, 14/112). In 2014, EVs were mainly of CV-A16 and EV-A71, but CV-A6 was the predominant type in 2015 (68.2%, 232/340) and in 2016 (38.6%, 151/391). The epidemic season of EVs was mostly from April to August, but CV-A6 showed a small epidemic peak from October to November. The male-to-female ratio of EV-positive patients was 1.50∶1, and EV-associated diseases mostly occurred in children under 5 years of age. Younger children were more susceptible to CV-A6 than to EV-A71 and CV-A16. Conclusions: From 2010 to 2016, there was a significant change in the spectrum of EVs in children with EV-associated diseases in Beijing. Since 2013, non-EV-A71 and non-CV-A16 increased, and CV-A6 gradually became one of the major pathogens of EV-associated diseases. The modified PCR primers and amplification conditions can effectively improve the reliability of test results.

Prevalence and reactivity of anti-melanoma differentiation-associated gene 5 (anti-MDA-5) autoantibody in Brazilian patients with dermatomyositis

Abstract: Background: There have been no studies to date on the frequency and reactivity of aanti-melanoma differentiation-associated gene 5 (anti-MDA-5) in samples from the Brazilian population with dermatomyositis. Objectives: To analyze this autoantibody in the Brazilian population. Methods: This was a single-center cross-sectional study in which 131 consecutive adult patients (109 dermatomyositis and 22 clinically amyopathic dermatomyositis) with active disease were evaluated from 2000 to 2016. Analysis of the anti-MDA-5 autoantibody was performed by ELISA. Results: The presence of this autoantibody was observed in 14.7% and 22.7% of patients with dermatomyositis and clinically amyopathic dermatomyositis, respectively. In the case of dermatomyositis, the autoantibody was associated less frequently with Raynaud's phenomenon and periungual hyperemia (P<0.05). In clinically amyopathic dermatomyositis, the presence of this autoantibody was not associated statistically with any demographic, clinical, laboratory, or imaging characteristics. Study limitations: The cross-sectional study design did not allow establishing a temporal correlation between anti-MDA-5 autoantibody and various study variables. In addition, pulmonary function tests were not performed in the patients. Conclusions: The frequency of anti-MDA-5 autoantibody was comparable to that of other populations with dermatomyositis, but with a different reactivity than described in the literature. In addition, there was a phenotypic variability between our patients with clinically amyopathic dermatomyositis and those described in the literature. Further studies are needed to confirm the current study's findings and elucidate this autoantibody's reactivity in Brazilians with idiopathic inflammatory myopathies.

Pathogen spectrum in enteroviral infections among children in Beijing from 2010 to 2016 / 中华儿科杂志

Objective@#To understand the epidemiological and etiological characteristics of enterovirus (EV)-associated diseases among children in Beijing from 2010 to 2016.@*Methods@#This was a repeated cross-sectional study. The throat swabs were collected from children with probable EV-associated diseases at the Children' s Hospital Affiliated to Capital Institute of Pediatrics from 2010 to 2016. The samples were sent for pan-EV, enterovirus 71 (EV-A71) and coxsackievirus A16 (CV-A16) detection by real-time fluorescence reverse transcription polymerase chain reaction (RT-PCR) . The viral types of non-EV-A71 and non-CV-A16 EV-positive samples were identified using modified RT-PCR and sequencing with CV-A6, EV-A/B group and 5 'UTR universal primers. The constituent ratios of the prevalence of different EV types in different age and gender groups were compared.@*Results@#Of the 2 703 throat swabs, 1 992 (73.7%) samples were positive for EV, including EV-A71 (19.1%, 516/2 703), CV-A16 (24.3%, 658/2 703), CV-A6 (22.2%, 600/2 703), CV-A10 (4.5%, 122/2 703) and other types of EV (3.5%, 95/2 703). There was 1 case of EV-A71 and CV-A16 co-infection. The positive detection rate of EV-A group (excluding EV-A71, CV-A16, CV-A6 and CV-A10) increased from 11.3% (7/62) to 95.2% (59/62) after using the modified VP1-specific primers and PCR amplification conditions. During the period between 2010 and 2012, CV-A16 and EV-A71 predominated in EV-positive samples. However, CV-A6 accounted for 60.7% (68/112) in 2013, much higher than CV-A16 (23.2%, 26/112) and EV-A71 (12.5%, 14/112). In 2014, EVs were mainly of CV-A16 and EV-A71, but CV-A6 was the predominant type in 2015 (68.2%, 232/340) and in 2016 (38.6%, 151/391). The epidemic season of EVs was mostly from April to August, but CV-A6 showed a small epidemic peak from October to November. The male-to-female ratio of EV-positive patients was 1.50∶1, and EV-associated diseases mostly occurred in children under 5 years of age. Younger children were more susceptible to CV-A6 than to EV-A71 and CV-A16.@*Conclusions@#From 2010 to 2016, there was a significant change in the spectrum of EVs in children with EV-associated diseases in Beijing. Since 2013, non-EV-A71 and non-CV-A16 increased, and CV-A6 gradually became one of the major pathogens of EV-associated diseases. The modified PCR primers and amplification conditions can effectively improve the reliability of test results.

The impact of epidemics of vaccine-preventable disease on vaccine uptake: lessons from the 2011-2012 US pertussis epidemic.

Conventional wisdom suggests that if there is a vaccine that is effective in preventing a disease, vaccine uptake will increase when the disease risk is high. Recent evidence, however, suggests that this may not always be the case. In a study we conducted in Washington State, we found no population-level increase in pertussis vaccination of infants during a pertussis epidemic. In this paper, we aim to review what is known about the history of vaccine uptake during epidemics of vaccine-preventable disease, the challenges facing public health campaigns responding to these epidemics, and how the effect of a vaccine-preventable disease epidemic on vaccine uptake can be studied.

Study on the epidemiological characteristics of rubella from 2008 to 2013 in Chongqing / 重庆医学

Objective To analyze the epidemiological characteristics of rubella since 2008 ,while the vaccine first used in Chongqing .Methods Descriptive epidemiological study was applied to analyze the cases on rubella from 2008 to 2013 ,and the Excel was used for data analysis .Results From 2008 to 2010 ,the rubella incidence rate reported in Chongqing decreased from 18 .97 per 100 000 to 2 .07 per 100 000 ,but it gave a rebounding trend in 2011 to 2012 .The rubella cases mostly affected children of 6 -14 years old and the epidemic peak was from April to June .Although ,the vaccination rate of rubella increased year by year from 2008 to 2013 ,even in 2012 it reached up to 90% ,but the vaccination coverage was low in primary and middle schools .100 epidemic out‐breaks happened ,91% of which happened in primary and middle schools ,accounting for 18 .74% of all reported cases .Conclusion Students in primary and middle school were easily infected with rubella virus ,the vaccination work should be strengthened for fur‐ther control the rubella infection .Secondary immune of Rubella vaccine of 6 or 7 years old children will contribute to control the outbreak of rubella among school‐age children ,and the rubella vaccine should expand its immunization objects .

Analysis of epidemiological characteristics of 11 142 injuries / 中华疾病控制杂志

Objective To study the characteristics of injuries in patients,and provide basic evidence for injury prevention and control.Methods 3 hospitals were sampled by stratified sampling,and the data of all injured patients visiting the 3 hospitals in 2006～2007 were analyzed.Results 11 142 injured patients were collected.The ratio of male to female was 1.81∶1.The average age was 34.56?16.Injured patients were mainly peasants(40.04%) and students(20.62%).Most injuries occurred at home and highway,and at 9～10AM and 3～4PM.The cause of injuries were fall(32.12%),traffic accidents(20.33%) blunt force(16.60%),and animal attacks(11.67%).Unintentionally injured patients accounted for 87.70% of all cases.Conclusions The occupation injury,traffic injury and injury to young adolescents are seriously endangering the health of peasants and students.