Effectiveness and safety of tetanus vaccine administration by intramuscular vs. subcutaneous route in anticoagulated patients: Randomized clinical trial in primary care.

Design: Prospective, double-blind clinical trial comparing tetanus-diphtheria vaccine administration routes, intramuscular (IM) vs. subcutaneous (SC) injection, in patients with oral anticoagulants. ISRCTN69942081. Study population: Patients treated with oral anticoagulants, 15 health centers, Vigo (Spain). Sample size, 117 in each group. Outcome variables: Safety analysis: systemic reactions and, at the vaccine administration site, erythematic, swelling, hematoma, granuloma, pain.Effectiveness analysis: differences in tetanus toxoid antibody titers.Independent variables: route, sex, age, baseline serology, number of doses administered. Analysis: Following the CONSORT guidelines, we performed an intention-to-treat analysis. We conducted a descriptive study of the variables included in both groups (117 in each group) and a bivariate analysis. Fewer than 5% of missing values. Imputation in baseline and final serology with the median was performed. Lost values were assumed to be values missing at random. We conducted a descriptive study of the variables and compared routes. For safety, multivariate logistic regression was applied, with each safety criterion as outcome and the independent variables. Odds ratios (ORs) were calculated. For effectiveness, a generalized additive mixed model, with the difference between final and initial antibody titers as outcome. Due to the bimodal distribution of the outcome, the normal mixture fitting with gamlssMX was used. All statistical analyses were performed with the gamlss.mx and texreg packages of the R free software environment. Results: A previously published protocol was used across the 6-year study period. The breakdown by sex and route showed: 102 women and 132 men; and 117 IM and 117 SC, with one dose administered in over 80% of participants. There were no differences between groups in any independent variable. The second and third doses administered were not analyzed, due to the low number of cases. In terms of safety, there were no severe general reactions. Locally, significant adjusted differences were observed: in pain, by sex (male, OR: 0.39) and route (SC, OR: 0.55); in erythema, by sex (male, OR: 0.34) and route (SC, OR: 5.21); and in swelling, by sex (male, OR: 0.37) and route (SC, OR: 2.75). In terms of effectiveness, the model selected was the one adjusted for baseline serology.

Adverse events analysis as an educational tool to improve patient safety culture in primary care: a randomized trial.

BACKGROUND: Patient safety is a leading item on the policy agenda of both major international health organizations and advanced countries generally. The quantitative description of the phenomena has given rise to intense concern with the issue in institutions and organizations, leading to a number of initiatives and research projects and the promotion of patient safety culture, with training becoming a priority both in Spain and internationally. To date, most studies have been conducted in a hospital setting, even though primary care is the type most commonly used by the public, in our experience. Our study aims to achieve the following:--Assess the registry of adverse events as an education tool to improve patient safety culture in the Family and Community Teaching Units of Galicia.--Find and analyze educational tools to improve patient safety culture in primary care.--Evaluate the applicability of the Hospital Survey on Patient Safety Culture by the Agency for Healthcare Research and Quality, Spanish version, in the context of primary health care. DESIGN: Experimental unifactorial study of two groups, control and intervention. STUDY POPULATION: Tutors and residents in Family and Community Medicine in last year of studies in Galicia, Spain. SAMPLE: From the population universe through voluntary participation. Twenty-seven tutor-resident units in each group required, randomly assigned. INTERVENTION: Residents and their respective tutor (tutor-resident pair) in teaching units on Family and Community Medicine from throughout Galicia will be invited to participate. Tutor-resident pair that agrees to participate will be sent the Hospital Survey on Patient Safety Culture. Then, tutor-resident pair will be assigned to each group--either intervention or control--through simple random sampling. The intervention group will receive specific training to record the adverse effects found in patients under their care, with subsequent feedback, after receiving instruction on the process. No action will be taken in the control group. After the intervention has ended, the survey will once again be provided to all participants. OUTCOME MEASURES: Change in safety culture as measured by Hospital Survey on Patient Safety CultureCONSORT Extension for Non-Pharmacologic Treatments 2008 was applied. DISCUSSION: The most significant limitations on the project are related to selecting a tool to measure the safety environment, the training calendar of residents in Family and Community Medicine in last year of studies and the no-answer bias inherent to research conducted through self-administered surveys.The development and application of a safety culture in the health sector, specifically in primary care, is as yet limited. Thus, identifying the strengths and weaknesses in the safety environment may assist in designing strategies for improvement in the primary care health centers of our region. TRIAL REGISTRATION: ISRCTN: ISRCTN41911128.

[Diagnostic accuracy of STOP-Bang questionnaire on moderate sleep apnoea in primary care]. / Utilidad diagnóstica del cuestionario STOP-Bang en la apnea del sueño moderada en atención primaria.

OBJECTIVE: We aimed to compare the diagnostic utility of the STOP-Bang questionnaire for moderate apnoea against the gold standard (type I polysomnography) in a primary care setting. METHOD: Study of diagnostic utility in primary care. Estimated sample: 85 cases and 85 healthy controls. In convenience sampling, 203 patients were recruited by their physicians at six health centres. Twenty-five were excluded, and 57 women and 121 men, of whom 74 had apnoea-hypopnoea index (AHI) ≥15, were analyzed. STOP-Bang was validated by comparing scores in the same patient with the apnoea-hypopnoea index observed in polysomnography, as a gold standard. Sample size, ROC curve analysis and optimal cut-off points were identified with the easyROC, pROC, and OptimalCutpoints packages. RESULTS: The area under the curve in moderate apnoea (AHI ≥15) of the STOP-Bang was 0.777 (0.667-0.808), with optimal cut-off points different by sex (4 in women and 6 in men). In the cross-validation with k=10, the area under the curve for the STOP-Bang was 0.678. CONCLUSIONS: The STOP-Bang presents a diagnostic moderate utility for AHI≥15, but superior to other scales, in a community population. Its performance is more appropriate in women.