Effectiveness of a combined strategy to improve therapeutic compliance and degree of control among patients with hypercholesterolaemia: a randomised clinical trial.

BACKGROUND: In subjects with hypercholesterolaemia, cholesterol values remain above guideline levels. One of the limiting factors to the achievement of goals in such patients is therapeutic non-adherence. The aim of this study is to assess the effectiveness of an intervention designed to improve control of hypercholesterolaemic patients, consisting of a combined strategy that would include the delivery of printed information, treatment-compliance check cards and the dispatch of text messages as complementary measures in support of the intervention at the general practitioner's practice. METHODS/DESIGN: A randomised, parallel-group clinical trial will be conducted at the family medicine outpatient facilities of eight health centres in three of Spain's Autonomous Regions (Comunidades Autónomas), covering a total of 358 subjects aged 18 years or over with diagnosis of hypercholesterolaemia. Patients in the intervention group will be supplied with printed material with information on the disease and its management, mobile-telephone text messages with guideline summaries, reminders of forthcoming appointments and/or arrangements for making new appointments in the event of non-attendance, and self-report cards to check compliance with recommendations. Both groups -intervention and control- will receive routine recommendations from their physicians in accordance with current European clinical practice guidelines for hypercholesterolaemia and cardiovascular risk management. As regards the measurements to be made, the main variable is the proportion of subjects who attain the low density lipoprotein cholesterol levels set as a target across a follow-up period of 24 months. The secondary variables are as follows: adherence to recommendations on lifestyle and adherence to drug treatment; variation in lipid profiles and cardiovascular risk levels; appearance of cardiovascular events; physical activity; food consumption; smoking habit; anthropometric measures; blood pressure; health problems; use of hypolipidaemic agents; socio-demographic data; beliefs and expectations about preventive recommendations; and degree of satisfaction with the combined strategy. DISCUSSION: Should this intervention prove effective, a recommendation could be issued on the application of this combined strategy to subjects with hypercholesterolaemia. It is a simple, relatively inexpensive intervention. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02314663.

Barriers to improved dyslipidemia control: Delphi survey of a multidisciplinary panel.

OBJECTIVE: To assess the barriers that make it difficult for the health care professionals (physicians, nurses and health care managers) to achieve a better control for dyslipidemia in Spain. METHODS: The study has an observational design and was performed using the modified Delphi technique. One hundred and forty-nine panel members from medicine, nursing and health care management fields and from different Spanish regions were selected randomly and were invited to participate. Individual and anonymous opinions were asked by answering a 42-items questionnaire via e-mail (two rounds were done). Level of agreement was assessed using measures of central tendency and dispersion. We analysed commonalities/differences between the three groups (Kappa index and McNemar chi-square). RESULTS: Response rate: 81%. The agreement index was 33.3 (95% CI: 18.9-47.7). Regarding the non-compliance with therapy, it improves with patient education degree in dyslipidemia, patient motivation, the agreement on decisions with the patient and with the use of cardiovascular risk measure and it gets worse with lack of information on the objectives to achieve. Clinical inertia improves with professional's motivation, cardiovascular risk calculation, training on objectives and the use of indicators and it gets worse with lack of treatment goals. CONCLUSION: Different perceptions and attitudes between medicine, nursing and health care management were found. An agreement in interventions in non-compliance and clinical inertia to improve dyslipidemia control was reached.

The safety and efficacy of the tetanus vaccine intramuscularly versus subcutaneously in anticoagulated patients: a randomized clinical trial.

BACKGROUND: In patients treated with oral anticoagulants, subcutaneous injections of anti-tetanus vaccine are usually recommended to reduce the risk of bleeding, although the effectiveness of the vaccine has only been proven for intramuscular injection. The objective of this study was to compare the safety and efficacy of intramuscular and subcutaneous injections of tetanus-diphtheria vaccine in patients treated with oral anticoagulants. METHODS/DESIGN: We present a prospective, double blinded, clinical trial comparing two groups of patients with oral anticoagulants: one group was administered tetanus-diphtheria vaccine by intramuscular injection, while the other was administered the same vaccine by subcutaneous injection. Allocation to each group was randomized and the duration of the study was six years. STUDY POPULATION: all patients treated with oral anticoagulants, who had been administered with at least one dose of vaccine, at 15 Health Centres in Vigo (Spain), and who agreed to participate in the study. The sample size was 115 patients in each group. The main variables for the safety analysis were the measurement of the brachial diameter, the appearance of basic injuries at the vaccine administration site, the appearance of pain and systemic reactions. The variable used for the efficacy analysis was a significant increase in the titres of anti-tetanus toxoid antibodies.An Intention-to-treat analysis will be performed. Details will be classified according to the administration route, while within each group a 3-tiered stratification will be defined by the administered number of doses. As a measure of association, relative risk will be estimated; the reduction of relative risk will also measured. For safety and to control the confounder effect, a logistic regression analysis will be carried out. As a measure of impact the reduction of absolute risk in relation to the total number of patients to be treated and the Number Needed to Treat will be estimated.CONSORT 2010 guidelines were applied for reporting parallel group randomised trials. DISCUSSION: The most significant difficulties on the project are related to the large number of participating centres, required to obtain a viable study population sample size, and the coordination given the scattering of the centres and researchers. TRIAL REGISTRATION: ISRCTN69942081.

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.

Efficacy of a Combined Strategy to Improve Low-density Lipoprotein Cholesterol Control Among Patients With Hypercholesterolemia: A Randomized Clinical Trial.

INTRODUCTION AND OBJECTIVES: Several interventions can improve low-density lipoprotein cholesterol (LDL-C) control. Our main objective was to evaluate the efficacy of a combined intervention to improve LDL-C control in patients with hypercholesterolemia. The study also assessed the efficacy of the intervention in improving adherence (pharmacological, diet, and exercise). METHODS: A multicenter, parallel group, randomized clinical trial (primary care) was conducted in 358 adults diagnosed with hypercholesterolemia, whether receiving prior drug therapy or not. We compared 178 participants who received the combined intervention (written material, self-completed registration cards, and messages to mobile telephones) with 178 controls. The main outcome variable was the proportion of participants with adequate LDL-C control (target levels of the European guidelines on dyslipidemia and cardiovascular risk) at 24 months. RESULTS: At 24 months, the mean reduction in LDL-C was significantly higher in the intervention group (23.8mg/dL [95%CI, 17.5-30.1]) than in the control group (14.6mg/dL [95%CI, 8.9-20.4]; P=.034). The mean LDL-C decrease was 13.1%±28.6%. At 1 year, the proportion of participants with adequate control was significantly higher in the intervention group than in the control group (43.7% vs 30.1%; P=.011; RR, 1.46). Adherence was significantly higher in the intervention group, both to drug therapy (77.2% vs 64.1%; P=.029) and exercise (64.9% vs 35.8; P<.001), but not to diet. CONCLUSIONS: The combined intervention significantly reduced LDL-C (by more than 13% at 2 years) and improved the degree of LDL-C control in patients with hypercholesterolemia at 1 year.