25 research outputs found

    Oral versus intramuscular administration of vitamin B12 for vitamin B12 deficiency in primary care : a pragmatic, randomised, non-inferiority clinical trial (OB12)

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    The trial was financed by Ministerio de Sanidad y Consumo Español through their call for independent clinical research, Orden Ministerial SAS/2377, 2010 (EC10-115, EC10-116, EC10-117, EC10-119, EC10-122); CAIBER—Spanish Clinical Research Network, Instituto de Salud Carlos III (ISCIII) (CAI08/010044); and Gerencia Asistencial de Atención Primaria de Madrid. This study is also supported by the Spanish Clinical Research Network (SCReN), funded by ISCIII-Subdirección General de Evaluación y Fomento de la Investigación, project number PT13/0002/0007, within the National Research Program I+D+I 2013-2016 and co-funded with European Union ERDF funds (European Regional Development Fund). This project received a grant for the translation and publication of this article from the Foundation for Biomedical Research and Innovation in Primary Care (FIIBAP) Call 2017 for grants to promote research programs.Objectives To compare the effectiveness of oral versus intramuscular (IM) vitamin B12 (VB12) in patients aged ≥65 years with VB12 deficiency. Design Pragmatic, randomised, non-inferiority, multicentre trial in 22 primary healthcare centres in Madrid (Spain). Participants 283 patients ≥65 years with VB12 deficiency were randomly assigned to oral (n=140) or IM (n=143) treatment arm. Interventions The IM arm received 1 mg VB12 on alternate days in weeks 1–2, 1 mg/week in weeks 3–8 and 1 mg/month in weeks 9–52. The oral arm received 1 mg/day in weeks 1–8 and 1 mg/week in weeks 9–52. Main outcomes Serum VB12 concentration normalisation (≥211 pg/mL) at 8, 26 and 52 weeks. Non-inferiority would be declared if the difference between arms is 10% or less. Secondary outcomes included symptoms, adverse events, adherence to treatment, quality of life, patient preferences and satisfaction. Results The follow-up period (52 weeks) was completed by 229 patients (80.9%). At week 8, the percentage of patients in each arm who achieved normal B12 levels was well above 90%; the differences in this percentage between the oral and IM arm were −0.7% (133 out of 135 vs 129 out of 130; 95% CI: −3.2 to 1.8; p>0.999) by per-protocol (PPT) analysis and 4.8% (133 out of 140 vs 129 out of 143; 95% CI: −1.3 to 10.9; p=0.124) by intention-to-treat (ITT) analysis. At week 52, the percentage of patients who achieved normal B12 levels was 73.6% in the oral arm and 80.4% in the IM arm; these differences were −6.3% (103 out of 112 vs 115 out of 117; 95% CI: −11.9 to −0.1; p=0.025) and −6.8% (103 out of 140 vs 115 out of 143; 95% CI: −16.6 to 2.9; p=0.171), respectively. Factors affecting the success rate at week 52 were age, OR=0.95 (95% CI: 0.91 to 0.99) and having reached VB12 levels ≥281 pg/mL at week 8, OR=8.1 (95% CI: 2.4 to 27.3). Under a Bayesian framework, non-inferiority probabilities (Δ>−10%) at week 52 were 0.036 (PPT) and 0.060 (ITT). Quality of life and adverse effects were comparable across groups. 83.4% of patients preferred the oral route. Conclusions Oral administration was no less effective than IM administration at 8 weeks. Although differences were found between administration routes at week 52, the probability that the differences were below the non-inferiority threshold was very low.Publisher PDFPeer reviewe

    Patient preferences and treatment safety for uncomplicated vulvovaginal candidiasis in primary health care

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    <p>Abstract</p> <p>Background</p> <p>Vaginitis is a common complaint in primary care. In uncomplicated candidal vaginitis, there are no differences in effectiveness between oral or vaginal treatment. Some studies describe that the preferred treatment is the oral one, but a Cochrane's review points out inconsistencies associated with the report of the preferred way that limit the use of such data. Risk factors associated with recurrent vulvovaginal candidiasis still remain controversial.</p> <p>Methods/Design</p> <p>This work describes a protocol of a multicentric prospective observational study with one year follow up, to describe the women's reasons and preferences to choose the way of administration (oral vs topical) in the treatment of not complicated candidal vaginitis. The number of women required is 765, they are chosen by consecutive sampling. All of whom are aged 16 and over with vaginal discharge and/or vaginal pruritus, diagnosed with not complicated vulvovaginitis in Primary Care in Madrid.</p> <p>The main outcome variable is the preferences of the patients in treatment choice; secondary outcome variables are time to symptoms relief and adverse reactions and the frequency of recurrent vulvovaginitis and the risk factors. In the statistical analysis, for the main objective will be descriptive for each of the variables, bivariant analysis and multivariate analysis (logistic regression).. The dependent variable being the type of treatment chosen (oral or topical) and the independent, the variables that after bivariant analysis, have been associated to the treatment preference.</p> <p>Discussion</p> <p>Clinical decisions, recommendations, and practice guidelines must not only attend to the best available evidence, but also to the values and preferences of the informed patient.</p

    Surgical site infection after gastrointestinal surgery in high-income, middle-income, and low-income countries: a prospective, international, multicentre cohort study

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    Background: Surgical site infection (SSI) is one of the most common infections associated with health care, but its importance as a global health priority is not fully understood. We quantified the burden of SSI after gastrointestinal surgery in countries in all parts of the world. Methods: This international, prospective, multicentre cohort study included consecutive patients undergoing elective or emergency gastrointestinal resection within 2-week time periods at any health-care facility in any country. Countries with participating centres were stratified into high-income, middle-income, and low-income groups according to the UN's Human Development Index (HDI). Data variables from the GlobalSurg 1 study and other studies that have been found to affect the likelihood of SSI were entered into risk adjustment models. The primary outcome measure was the 30-day SSI incidence (defined by US Centers for Disease Control and Prevention criteria for superficial and deep incisional SSI). Relationships with explanatory variables were examined using Bayesian multilevel logistic regression models. This trial is registered with ClinicalTrials.gov, number NCT02662231. Findings: Between Jan 4, 2016, and July 31, 2016, 13 265 records were submitted for analysis. 12 539 patients from 343 hospitals in 66 countries were included. 7339 (58·5%) patient were from high-HDI countries (193 hospitals in 30 countries), 3918 (31·2%) patients were from middle-HDI countries (82 hospitals in 18 countries), and 1282 (10·2%) patients were from low-HDI countries (68 hospitals in 18 countries). In total, 1538 (12·3%) patients had SSI within 30 days of surgery. The incidence of SSI varied between countries with high (691 [9·4%] of 7339 patients), middle (549 [14·0%] of 3918 patients), and low (298 [23·2%] of 1282) HDI (p < 0·001). The highest SSI incidence in each HDI group was after dirty surgery (102 [17·8%] of 574 patients in high-HDI countries; 74 [31·4%] of 236 patients in middle-HDI countries; 72 [39·8%] of 181 patients in low-HDI countries). Following risk factor adjustment, patients in low-HDI countries were at greatest risk of SSI (adjusted odds ratio 1·60, 95% credible interval 1·05–2·37; p=0·030). 132 (21·6%) of 610 patients with an SSI and a microbiology culture result had an infection that was resistant to the prophylactic antibiotic used. Resistant infections were detected in 49 (16·6%) of 295 patients in high-HDI countries, in 37 (19·8%) of 187 patients in middle-HDI countries, and in 46 (35·9%) of 128 patients in low-HDI countries (p < 0·001). Interpretation: Countries with a low HDI carry a disproportionately greater burden of SSI than countries with a middle or high HDI and might have higher rates of antibiotic resistance. In view of WHO recommendations on SSI prevention that highlight the absence of high-quality interventional research, urgent, pragmatic, randomised trials based in LMICs are needed to assess measures aiming to reduce this preventable complication

    Long Persistence of Methicillin-Susceptible Strains of Staphylococcus aureus Causing Sepsis in a Neonatal Intensive Care Unit▿

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    Molecular epidemiology of Staphylococcus aureus strains causing bacteremia in neonates during 2002 to 2005 revealed seven clones, with four MSSA clones responsible for 80% of the cases. Some clones persisted or reappeared throughout the study. Three bacteremic clones were found colonizing health care workers (HCWs), particularly clone C, which was harbored by at least 15% of HCWs

    La Educación para la Salud de la Cátedra Ambulante de Huelva (1956-1977)

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    Con el objetivo de identificar la labor educadora en materia de salud realizada por las divulgadoras sanitario-sociales de las Cátedras Ambulantes de la Sección Femenina en la provincia de Huelva durante el periodo de 1956 a 1977, se ha realizado este estudio histórico, consultando fuentes primarias encontradas en el Archivo Histórico Provincial de Huelva. A través del Programa de Puericultura e Higiene, el curso de Madres Ejemplares, el curso de Socorrismo y otras acciones específicas se pretendió mejorar la Higiene y la Salud Pública en los 61 municipios donde la cátedra llegó, alcanzando con sus actuaciones a gran parte de la población de estas zonas rurales. Las principales destinatarias fueron las mujeres, pero los hombres también participaron en esta formación, recibiendo cursos de Higiene. La divulgadora de la Cátedra Ambulante contó con el apoyo de otros agentes sanitarios en su labor educadora, principalmente, el médico de la localidad, el practicante, o personal sanitario de empresas de la zona. La elevada asistencia y motivación por el programa de Educación para la Salud estuvo impulsado por la aplicabilidad del aprendizaje en lo cotidiano para satisfacer la necesidad de mejorar el estado de salud en un medio con escasos recursos

    La Educación para la Salud de la Cátedra Ambulante de Huelva (1956-1977)

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    This historical study has been carried out with the aim of identifying the educational work in health carried out by the health-social educators (‘divulgadoras’) of the Falange´s ‘Sección Femenina’ Travelling Chairs (‘Cátedras Ambulantes’) in the province of Huelva during the period from 1956 to 1977, consulting primary sources found in the Provincial Historical Archive of Huelva. Through the Puericulture and Hygiene Program, the Exemplary Mothers course, the First Aid course and other specific actions, the aim was to improve Hygiene and Public Health in the 61 municipalities where the Chair was active, reaching a large part of the population of these rural areas. The main beneficiaries were women, but men also participated in this training, receiving Hygiene courses. The ‘divulgadora’ of the ‘Cátedra Ambulante’ was supported by other health agents in her educational work, mainly by the local doctor, nurse, or sanitary personnel from companies in the area. The high attendance and motivation for the Health Education program was impelled by the applicability of learning in everyday life to meet the need to improve the state of health in an environment with scarce resources.Con el objetivo de identificar la labor educadora en materia de salud realizada por las divulgadoras sanitario-sociales de las Cátedras Ambulantes de la Sección Femenina en la provincia de Huelva durante el periodo de 1956 a 1977, se ha realizado este estudio histórico, consultando fuentes primarias encontradas en el Archivo Histórico Provincial de Huelva. A través del Programa de Puericultura e Higiene, el curso de Madres Ejemplares, el curso de Socorrismo y otras acciones específicas se pretendió mejorar la Higiene y la Salud Pública en los 61 municipios donde la cátedra llegó, alcanzando con sus actuaciones a gran parte de la población de estas zonas rurales. Las principales destinatarias fueron las mujeres, pero los hombres también participaron en esta formación, recibiendo cursos de Higiene. La divulgadora de la Cátedra Ambulante contó con el apoyo de otros agentes sanitarios en su labor educadora, principalmente, el médico de la localidad, el practicante, o personal sanitario de empresas de la zona. La elevada asistencia y motivación por el programa de Educación para la Salud estuvo impulsado por la aplicabilidad del aprendizaje en lo cotidiano para satisfacer la necesidad de mejorar el estado de salud en un medio con escasos recursos

    La Educación para la Salud de la Cátedra Ambulante de Huelva (1956-1977)

    No full text
    Con el objetivo de identificar la labor educadora en materia de salud realizada por las divulgadoras sanitario-sociales de las Cátedras Ambulantes de la Sección Femenina en la provincia de Huelva durante el periodo de 1956 a 1977, se ha realizado este estudio histórico, consultando fuentes primarias encontradas en el Archivo Histórico Provincial de Huelva. A través del Programa de Puericultura e Higiene, el curso de Madres Ejemplares, el curso de Socorrismo y otras acciones específicas se pretendió mejorar la Higiene y la Salud Pública en los 61 municipios donde la cátedra llegó, alcanzando con sus actuaciones a gran parte de la población de estas zonas rurales. Las principales destinatarias fueron las mujeres, pero los hombres también participaron en esta formación, recibiendo cursos de Higiene. La divulgadora de la Cátedra Ambulante contó con el apoyo de otros agentes sanitarios en su labor educadora, principalmente, el médico de la localidad, el practicante, o personal sanitario de empresas de la zona. La elevada asistencia y motivación por el programa de Educación para la Salud estuvo impulsado por la aplicabilidad del aprendizaje en lo cotidiano para satisfacer la necesidad de mejorar el estado de salud en un medio con escasos recursos

    High Vancomycin MIC and Complicated Methicillin-Susceptible Staphylococcus aureus Bacteremia

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    We conducted a retrospective study of 99 patients with methicillin-suseptible Staphylococcus aureus catheter-related bacteremia in which vancomycin MIC was determined by Etest. High vancomycin MIC (>1.5 μg/mL) was the only independent risk factor for development of complicated bacteremia caused by methicillin-susceptible S. aureus (odds ratio 22.9, 95% confidence interval 6.7–78.1)
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