Study design: what's in a name?

The name of the study should properly reflect the actual conduct and analysis of the study. This short paper provides guidance on how to properly name the study design. The first distinction is between a trial (intervention given to patients to study its effect) and an observational study. For observational studies, it should further be decided whether it is cross-sectional or whether follow-up time is taken into account (cohort or case-control study). The distinction prospective-retrospective has two disadvantages: prospective is often seen as marker of higher quality, which is not necessarily true; there is no unifying definition that makes a proper distinction between retrospective and prospective possible.

Physical restraint to patients with dementia in acute physical care settings: effect of the financial incentive to acute care hospitals.

ABSTRACTBackground:In April 2016, the Japanese government introduced an additional benefit for dementia care in acute care hospitals (dementia care benefit) into the universal benefit schedule of public healthcare insurance program. The benefit includes a financial disincentive to use physical restraint. The present study investigated the association between the dementia care benefit and the use of physical restraint among inpatients with dementia in general acute care settings. METHODS: A national cross-sectional study design was used. Eight types of care units from acute care hospitals under the public healthcare insurance program were invited to participate in this study. A total of 23,539 inpatients with dementia from 2,355 care units in 937 hospitals were included for the analysis. Dementia diagnosis or symptoms included any signs of cognitive impairment. The primary outcome measure was "use of physical restraint." RESULTS: Among patients, the point prevalence of physical restraint was 44.5% (n = 10,480). Controlling for patient, unit, and hospital characteristics, patients in units with dementia care benefit had significantly lower percentage of physical restraint than those in any other units (42.0% vs. 47.1%; adjusted odds ratio, 0.76; 95% confident interval [0.63, 0.92]). CONCLUSIONS: The financial incentive may have reduced the risk of physical restraint among patients with dementia in acute care hospitals. However, use of physical restraint was still common among patients with dementia in units with the dementia care benefit. An educational package to guide dementia care approach including the avoidance of physical restraint by healthcare professionals in acute care hospitals is recommended.

Prevalence of allergic diseases and/or allergic sensitisation in children and adolescents with type 1 diabetes mellitus

BACKGROUND: The prevalence of atopic diseases in children with type 1 diabetes mellitus (DM1) has been reported as lower. The aim of this study was to evaluate the prevalence of allergic diseases and allergic sensitisation in Brazilian children and adolescents with DM1. PATIENTS AND METHODS: 96 patients with DM1 (aged 4-18 years, 45 boys) followed for at least one year were evaluated for allergic disease through a detailed allergological anamnesis and skin prick tests (SPT) to inhalant allergens (Dermatophagoides pteronyssinus, D. farinae, Blomia tropicalis, Blattella germanica, Periplaneta americana, dog epithelium, cat epithelium, mix fungi), foods (cow's milk, egg-white, yolk, soy, wheat, corn), and positive (histamine 1 mg/ml) and negative (saline) controls. Wheals with a mean diameter of induration equal to or greater than 3 mm identified a positive SPT. RESULTS: The prevalence values of rhinitis, asthma and atopic eczema (isolated or associated) were 68.0%, 59.1% and 44.4%, respectively. 20.6% of the patients had no allergic disease. 46.8% of the patients had been diagnosed with DM1 for at least four years and there was no relationship between the period of DM1 and the presence of allergic disease, nor of the gender. 48.0% patients were sensitised with predominance of D. pteronyssinus, B. topicalis and D. farinae. The frequency of positive SPT was significantly higher among patients with history of allergic disease (OR = 6.98, 95%CI: 2.60-18.74, p < 0.001). CONCLUSION: The prevalence of allergic diseases and sensitisation in patients with DM1 was higher than usually expected and deserves further investigation to identify possible causes for these findings and to evaluate their importance and influence on the metabolic control

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Índice tornozelo-braço em pacientes hemodialíticos / Ankle-brachial index in hemodialysis patients

INTRODUÇÃO: Apesar da elevada mortalidade dos pacientes em hemodiálise devido às doenças cardiovasculares, é incomum a realização de exames diagnósticos para doença arterial obstrutiva periférica e artérias pouco compressíveis. OBJETIVOS: Analisar a prevalência de doença arterial obstrutiva periférica e artérias pouco compressíveis em hemodialisados, comparando-os com o Grupo Controle. MÉTODOS: Tratou-se de um estudo transversal, com 78 hemodialisados e 88 pacientes que não faziam hemodiálise com, pelo menos, dois fatores de risco para doença arterial obstrutiva periférica (Grupo Controle). Para aferição da pressão arterial sistólica, utilizou-se Doppler vascular portátil e esfigmomanômetro. Esta foi aferida somente nos membros que não possuíam fístula arteriovenosa. O índice tornozelo-braço foi calculado utilizando cada artéria do membro inferior. Foram considerados normais os valores de 0,9 a 1,3. RESULTADOS: Diagnosticou-se doença arterial obstrutiva periférica e artérias pouco compressíveis em 26,9 e 30,8%, dos hemodialisados, e em 33 e 22,7%, do Grupo Controle. Nos hemodialisados, verificou-se o índice tornozelo-braço alterado em 75% dos sintomáticos (p=0,005), em 67,3% dos homens e 31% das mulheres (p<0,005), em 78,6% dos idosos, 34,8% dos adultos jovens (p<0,01) e em 76,9% dos diabéticos (p<0,005 versus não diabéticos). Esses pacientes apresentaram maior prevalência de doença arterial obstrutiva periférica grave do que o Grupo Controle (p<0,01). CONCLUSÕES: O índice tornozelo-braço anormal foi muito prevalente nos grupos estudados; entretanto, os hemodialisados apresentaram alterações mais graves quando comparados ao Grupo Controle. Diabetes melito, sexo masculino e idade avançada foram fatores de risco importantes para a alteração do índice tornozelo-braço nos hemodialisados. O índice tornozelo-braço foi um bom método de rastreio para alterações pesquisadas. Portanto, a utilização deste na rotina de manejo de pacientes em hemodiálise é sugerida.

INTRODUCTION: Despite the high mortality in hemodialysis patients due to cardiovascular diseases, it is unusual performing diagnostic tests for peripheral arterial disease and poorly compressible arteries. OBJECTIVES: To analyze the prevalence of peripheral arterial disease and poorly compressible arteries in hemodialysis patients, by comparing them to the Control Group. METHODS: It was a cross-sectional study with 78 hemodialysis patients and 88 non-hemodialysis patients with at least two risk factors for peripheral arterial disease (Control Group). To evaluate blood pressure, portable vascular Doppler and sphygmomanometer were used. The pressure was measured from the limb without arteriovenous fistula. The ankle-brachial index was calculated for each artery of the lower limb. It was considered normal ankle-brachial index from 0.9 to 1.3. RESULTS: We diagnosed peripheral arterial disease and poorly compressible arteries in 26.9 and 30.8% of hemodialysis patients and in 33 and 22.7% of the Control Group. In hemodialysis patients, we found abnormal ankle-brachial index in 75% of symptomatic patients (p=0.005), in 67.3% of men and 31% of women (p<0.005), in 78.6% of the elderly, 34.8% of young adults (p<0.01), and 76.9% of diabetics (p<0.005 versus nondiabetic). These patients had a higher prevalence of severe peripheral arterial disease than the Control Group. CONCLUSIONS: Abnormal ankle-brachial index was very prevalent in the groups studied; however, hemodialysis patients had more severe changes, when compared to the Control Group. Diabetes mellitus, male gender, and advanced age were important risk factors for abnormal ankle-brachial index in hemodialysis patients. The ankle-brachial index was a good method of screening for the studied changes; therefore, we suggest the routine use in the management of hemodialysis patients.

Presencia y persistencia de variantes moleculares del ORF E6 y ORF E7 del VPH 58 en mujeres con citología normal que pertenecen a la cohorte de Bogotá, Colombia / Presence and persistence of HPV 58 molecular variations ORF E6 and ORF E7 among women with normal cytology in the Bogotá, Colombia cohort

Objetivo: Analizar la presencia y persistencia de variantes en E6/E7/VPH 58 en muestras de mujeres con infecciones prevalentes por VPH 58, con citología normal, que pertenecen a la cohorte de Bogotá, Colombia. Métodos: Se utilizaron cepillados cervicales de 34 mujeres VPH 58, con citología normal, pertenecientes a la línea de base de la cohorte, con su respectivo seguimiento. Se amplificó la región E6/E7 del VPH 58 usando los iniciadores E6F1-E7R1 y los iniciadores E7P1-E7P2. Para el análisis de las variantes se utilizó la técnica de secuencia automática directa. La secuencia referencia del VPH 58 se utilizó para comparar las secuencias obtenidas. Resultados: En 27/34 muestras se lograron detectar variantes de E6/E7 de VPH 58. En total, se detectaron cinco variantes diferentes, dos de ellas nunca antes reportadas (A169/T307/A694/G744/A761 y T307/A694/G744/A761/G763). Los análisis de eliminación mostraron que el 75% de las variantes se habían eliminado antes de los dos años de seguimiento, y todas las variantes ya se habían eliminado a los seis años de seguimiento. Conclusiones: Dos nuevas variantes se reportaron a escala mundial de gran relevancia en los ámbitos filogenético y epidemiológico.

Objective: To analyze the presence and persistence of E6/E7 HPV58 variations in women with prevalent HPV 58 infection, with normal cytology, who belong to the Bogotá, Colombia cohort. Methods: Cervical cytobrush was used on 34 HPV58 women, with normal cytology, who are part of the cohort base line; respective follow was performed. The HPV58 E67/E7 region was broadened by using E6F1-E7R1 and E7P1-E7P2 indicators. Variation analysis was carried out with automatic direct sequencing. HPV58 sequence reference was used to compare the sequences that had been obtained. Results: In 27/34 samples, E6/E7 variations of HPV58 were successfully detected. A total of five different variations were detected, two of which had never been reported before (A169/T307/A694/G744/A761 and T307/A694/G744/A761/G763). Elimination analysis revealed that 75% of variations had been eliminated within two years of follow up, and that all variation had been eliminated at the end of six years of follow up. Conclusions: Two new variations of universal phylogenetic and epidemiologic noteworthiness were reported.