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.

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.

Long-term Effects of Plant Stanols on the Lipid Profile of Patients With Hypercholesterolemia. A Randomized Clinical Trial.

INTRODUCTION AND OBJECTIVES: Plant stanol consumption may improve long-term cholesterol control. The aim of the present study was to evaluate the effectiveness of 2g/day of plant stanols in reducing low-density lipoprotein cholesterol levels in patients with hypercholesterolemia. METHODS: This randomized, double-blind, and placebo-controlled study included 182 adults diagnosed with hypercholesterolemia. A yogurt drink containing 2g of plant stanols was administered to 91 participants in the intervention group; 91 participants in the control group received unsupplemented yogurt. The primary end point was the change in the lipid profile at 12 months. RESULTS: Low-density lipoprotein cholesterol levels at 12 months were significantly more reduced in the stanol intervention group than in the control group: 13.7 (95% confidence interval, 3.2-24.1) mg/dL (P=.011). A reduction of more than 10% in low-density lipoprotein cholesterol was achieved by a significantly higher proportion of participants in the intervention group (relative risk=1.7; 95% confidence interval, 1.1-2.7). In this group, the mean (standard deviation) level of low-density lipoprotein cholesterol decreased by 11.0% (23.9%). CONCLUSIONS: Our results confirm that administration of plant stanols at a dosage of 2 g/day for 12 months significantly reduces (by slightly more than 10%) the concentrations of low-density lipoprotein cholesterol in individuals with hypercholesterolemia. Trial registration (www.ClinicalTrials.gov): Current Controlled Trials NCT01406106.

[Adherence to patients antidepressant treatment and the factors associated of non-compiance]. / Seguimiento de la adherencia al tratamiento antidepresivo en pacientes que inician su consumo.

OBJECTIVE: To know the adherence to treatment in patients who initiate antidepressant drugs and to analyze the determinant factors of non-compliance, so much clinical as sociodemographic. DESIGN: Prospective longitudinal observational study. LOCATION: Primary Health Care and Mental Health Surgeries of three Castilla-La Mancha Areas. PARTICIPANTS: 185 adults patients who were started in antidepressant treatment were evaluated. MEASUREMENTS: Treatment adherence (test Haynes-Sackett, test Morisky-Green, count of tablets and MEMS), adverse effects, intensity of depressive symptoms, sociodemographic characteristics and other characteristics related to antidepressants or participants. RESULTS: After 6months of beginning antidepressing treatment, 46.9% (95%IC: 36.5-57.3) showed an inadequate fulfilment by pill count method and 28.6% (95%IC: 19.1-38.0) with Morisky-Green's questionnaire. To 15 days the lack of adherence was 48.5% (95%IC: 40.6-56.4) and of 33.5% (95%IC: 26.1-41.0). The 38.4% (95%IC: 31.1-45.7) demonstrated some side effect during the follow-up. Using proportional risk model of Cox the variables related to compliance were: younger age, level of instruction lower than secondary studies, free medicines for pensioner, no psychotherapeutic treatment, consume a fewer antidepressants drugs and a frequency ≤ 3 visits to the family doctor 3 months previous to the study. CONCLUSIONS: The non-compliance of antidepressant treatment in primary care is high from the first weeks after initiating it. The conditioning factors are related to sociodemographic characteristics and other patient characteristics as type of financing of pharmaceutical benefit and frequentness at primary care.

Functional status of elderly people with hearing loss.

The objective is to determine the prevalence of hearing loss in people over 65 years of age, to describe the functional status of people with hearing loss and to identify the need for hearing aid use. In a cross-sectional study, a random sample of 1387 people aged 65 years and over was selected. The primary study variables were: hearing level by audiometric assessment, self-perceived hearing loss, screening for hypoacusia using the Hearing Handicap Inventory for the Elderly-Screening (HHIE-S) and physical, cognitive and emotional functional status. Using the HHIE-S it was determined that 11.3% of the subjects had severe hearing handicap. According to the Ventry/Weinstein criteria 43.6% had hearing handicap. When asked about the use of hearing aids, 4.5% of the study subjects said they used them, although 41.9% had hearing loss of 35 dB or more in their better ear. The variables associated with the need for a hearing aid were age >75 years (odds ratio=OR=3.2), ADL dependence (OR=2.7), cognitive impairment (OR=2.0), multiple health problems (OR=1.8), male sex (OR=1.6) and single/widowed (OR=1.5). In conclusion, there is a high prevalence of hearing loss associated with other functional limitations. Of those people who would benefit from a hearing aid (more than a third of people over 65 years old), 89.3% do not own one. The screening of hearing loss needs to be improved.

Prescripción de la primera receta por el Médico Especialista / Prescription of first recipe by second level doctor

Objetivo. La circular 8/96 de INSALUD dictó instrucciones para prescripción de receta ofi cial enatención especializada. Según dicha circular, el médico especialista realizará la primera prescripciónen recetas ofi ciales a los pacientes dados de alta o atendidos en consultas. Puesto que no siempre se cumple, nos planteamos cuantifi car, sobre el total de la prescripción del médico de familia, la proporción de recetas que debieran haberse realizado en atención especializada y, sin embargo, se han realizado en atención primaria.Material y Métodos. Mediante un estudio descriptivo transversal se analizó la prescripción de cinco médicos de familia durante una semana, pertenecientes a tres Centros de Salud del Área Sanitaria de Albacete, diferenciando las prescripciones que deberían haber realizado los médicos de atención especializada e identifi cando las especialidades farmacéuticas y el origen de las mismas (servicio hospitalario y alta/consulta).Resultados. Los cinco médicos realizaron un total de 3102 recetas, conteniendo las especialidadesmás prescritas los siguientes principios activos: paracetamol, omeprazol y ácido acetil salicílico. Durante la semana de observación, 73 recetas deberían haber sido realizadas en atención especializada, suponiendo el 2,35% del total (IC95%:1,85–2,95). El origen más frecuente fue la consulta especializada (79,7% frente a 20,3% de altas hospitalarias) y, en cuanto a servicios hospitalarios, Reumatología (17,8%) y Oftalmología (15,1%). Los principios activosmás frecuentes fueron: paracetamol,calcio/colecalciferol y ketorolaco.Conclusiones. Entre el 1,85 y el 2,95% de las recetas que realiza el médico de familia deberíanrealizarse en el medio especializado. Aunque dicha proporción no es importante, contribuye aaumentar la carga burocrática que caracteriza la consulta del médico de familia

Objective. The document 8/96 by INSALUD, express the instructions in order to prescribe the official recipe by second health level. The document argues that second level doctor has the responsibility of fulfilment the recipe in patients attended by him. However, usually this instruction is un-fulfi lled and we want to quantify percentage of prescription by family doctors that would be made by second level doctor.Material and methods. By cross sectional descriptive research, it has been studied the prescriptionby fi ve family doctors at Albacete health area during one week by watching percentage of prescription what would be made by second level doctors, the medicament and the source.Results. The fi ve doctors have performed 3102 documents and they has been the more frequent prescription, paracetamol, omeprazol, and acetyl salicylic acid. During one week, 73 documents would be made by second level, it suppose 2.35 % of global prescription (IC 95%: 1.85 – 2.95). The more frequent source is second level consultancy (79.7% v.s. 20.3% of hospital check out;IC 95%: 1.85 – 2.95), Rheumatology (17.8%), Oftalmology (15.1%) and more frequent molecules was paracetamol, calcium / cholecalciferol and ketorolac.Conclusions. From 1.85 and 2.95% of recipes made by family doctor, they would be made bysecond level doctor. Despite it isn’t an important percentage, it increases burocratic charge onthe family practice consultancy

[Design and validation of a questionnaire for the detection of major depression in elderly patients]. / Diseño y validación de un cuestionario para la detección de depresión mayor en pacientes ancianos.

BACKGROUND AND OBJECTIVE: The aim of this study was to design and validate a scale to detect major depressive disorders in elderly individuals in primary care (Detection of Depression in the Elderly Scale [DDES]). METHODS: We performed an observational and cross-sectional study for the validation of a scale, administered by means of a personal interview, in 259 patients aged 65 years old or older. Available instruments were reviewed and the questions were designed. Subsequently, a first pilot study was performed. In a second pilot study the reproducibility of the instrument was analyzed. The gold standard was the result of a standardized psychiatric interview performed by psychiatrists (DSM-IV criteria and SCAN interviews). RESULTS: The intraclass correlation coefficients corresponding to the test-retest and inter-rater reliability were 0.858 (95% confidence interval [CI], 0.634-0.946) and 0.908 (95% CI, 0.726-0.969) respectively. Two hundred sixteen subjects underwent an assessment, in which primary care and psychiatric evaluations were blinded. Major depression was diagnosed in 81 patients (37.5%; 95% CI, 31.1-44.4). The internal consistency of the DDES was good (Cronbach's alpha = 0.79). Exploratory factorial analysis revealed an 8-component structure (55.8% of explained variance). A cutoff score of 15 or more for the DDES showed sensitivity of 90.1% (95% CI, 80.95-95.33), specificity of 74.8% (95% CI, 66.48-81.71) and a likelihood ratio (+) of 3.58 (95% CI, 2.65-4.83). CONCLUSIONS: The DDES is a clinically useful instrument for the detection of major depression in elderly patients in primary care.