Effectiveness of medication self-management, self-monitoring and a lifestyle intervention on hypertension in poorly controlled patients: The MEDICHY randomized trial.

Background: Uncontrolled hypertension is a common problem worldwide, despite the availability of many effective antihypertensive drugs and lifestyle interventions. We assessed the efficacy of a multi-component intervention in individuals with uncontrolled hypertension in a primary care setting. Methods: This study was a randomized, multicenter, parallel, two-arm, single-blind controlled trial performed in primary healthcare centers in Mallorca (Spain). All participants were 35 to 75-years-old and had poorly controlled hypertension. Patients were randomly assigned in a 1:1 ratio to a control group (usual care) or an intervention group (self-monitoring of blood pressure, self-titration of hypertensive medications, dietary interventions, and physical activity interventions). The primary outcome was decrease in the mean SBP at 6 months relative to baseline. Results: A total of 153 participants were randomized to an intervention group (77) or a control group (76). After 6 months, the intervention group had a significantly lower systolic blood pressure (135.1 mmHg [±14.8] vs. 142.7 mmHg [±15.0], adjusted mean difference: 8.7 mmHg [95% CI: 3.4, 13.9], p < 0.001) and a significantly lower diastolic blood pressure (83.5 mmHg [±8.8] vs. 87.00 mmHg [±9.0], adjusted mean difference: 5.4 [95% CI: 2.9, 7.8], p < 0.0001). The intervention group also had significantly more patients who achieved successful blood pressure control (<140/90 mmHg; 54.4% vs. 32.9%, p = 0.011). Discussion: Self-monitoring of blood pressure in combination with self-management of hypertensive medications, diet, and physical activity in a primary care setting leads to significantly lower blood pressure in patients with poorly controlled hypertension.Clinical Trial Registration: ClinicalTrials.gov, identifier ISRCTN14433778.

Diagnostic accuracy of Panbio™ rapid antigen test for SARS-CoV-2 in paediatric population.

BACKGROUND: Rapid antigen-detection tests (Ag-RDTs) are used to diagnose SARS-CoV-2 infection. Real-world studies of Ag-RDTs are necessary to evaluate their diagnostic yield in paediatric patients. Our aim was to evaluate the accuracy of the Panbio™ Rapid Antigen Test for SARS-CoV-2 in the setting of a primary health care centre (PHC), with use of the Reverse Transcription-Polymerase Chain Reaction (RT-PCR) as gold standard. METHODS: This prospective diagnostic study was conducted at PHCs in Mallorca, Spain. Patients were ≤ 18 years-old that attended sites for RT-PCR testing due to symptoms suggestive of infection (fever, headache, nasal congestion and dry cough, among others) or epidemiological exposure (close contacts). Two samples were collected: a nasal mid-turbinate sample for Ag-RDTs and a nasopharyngeal swab for RT-PCR testing. The sensitivity, specificity, and predictive values of the AgRDT were calculated using the RT-PCR results as the reference. RESULTS: We examined 1142 participants from 0 to 18 years (47.5% female, mean age 8.9 ± 4.8 years, median 9.0 [5.0-13.0]). There were 84 positive RT-PCR results (pre-test probability of 7.3%) and 52 positive Ag-RDT results. The sensitivity of the Ag-RDT was 59.5% (95% Confidence Interval (CI): 48.2-69.9%), the specificity was 99.8% (95%CI: 99.2-99.9%), the positive predictive value was 96.1% (95%CI: 85.6-99.4%), and the negative predictive value was 96.8% (95%CI: 95.6-97.7%). The sensitivity for individuals referred by a general practitioner (GP) or paediatrician due to symptoms was 71.4% (95%CI: 51.5-86.0%) and for asymptomatic individuals was 50.0% (95%CI: 9.1-90.8%). The specificity was greater than 98.9% overall and in all subgroups. The sensitivity was 73.0% (95%CI: 52.0-87.5%) for referred patients due to symptoms and who were tested within 5 days since symptom onset. No significant statistical differences between any groups were found. There were 34 false-negative Ag-RDT results (40.5%) and 2 false-positive Ag-RDT results (0.2%). CONCLUSION: The sensitivity of the Panbio™ Test in paediatric individuals is below the minimum of 80% recommended by the World Health Organization for Ag-RDTs. This test had better accuracy in individuals referred by a GP or paediatrician due to symptoms, rather than those who were asymptomatic or referred due to epidemiological exposure. The RT-PCR test using a nasopharyngeal swab is accurate, but a less invasive alternative that has better sensitivity than the Panbio™ Test is needed for paediatric populations.

Primary care is the frontline for help-seeking insomnia patients.

BACKGROUND: Although insomnia is a very common disorder, few people seek medical help. OBJECTIVES: To determine the proportion of people who consult a healthcare professional about insomnia and examine reasons for help seeking. METHODS: Descriptive study of 99 patients diagnosed with insomnia following a telephone survey of 466 adults assigned to a primary healthcare unit in Majorca (Spain). Data were obtained from interviews and subsequent review of electronic medical records. RESULTS: Thirty-nine patients (39.8%) consulted at least once with one health care professional; 36(92.2%) consulted a general practitioner. Only 12.2% had an insomnia diagnosis registered in their medical record. Insomnia consultation was not associated with any sociodemographic variables analysed, anxiety, depression or comorbidities. Also, there was no association with sleep quality, duration, and sleep efficiency. Patients with clinical insomnia (OR, 2.48; 95% CI, 1.03-5.94), those who were more worried (OR, 2.93; 95% CI 1.08-7.95) or felt that others noticed the impact of insomnia on their quality of life (OR, 2.48; 95% CI, 1.02-19.08) are more likely to seek medical help. Patients taking sleep medication were 21.54 (95% CI, 7.34-63.20) times more likely to have asked for medical assistance. CONCLUSION: Insomnia is an under-reported problem for both patients and doctors. When patients decide to consult for insomnia problems, they first go to the GP, and the vast majority take medications for their sleep problem. Those who consult most are people with more severe insomnia and those who are more worried.

Assessing the feasibility and acceptability of a cluster-randomized study of cognitive behavioral therapy for chronic insomnia in a primary care setting.

BACKGROUND: Cognitive behavioral therapy for chronic insomnia (CBT-i) is the treatment of choice for this condition but is underutilized in patients who attend primary care. The purpose of the present feasibility-pilot study was to assess the feasibility and acceptability of a cluster-randomized study of CBT-i in a primary care setting. METHODS: This study, performed at two primary health care centers in Majorca, Spain, was a mixed methods feasibility-pilot study of a parallel cluster-randomized design comparing CBT-i and usual care (UC). Patients were included if they were 18 to 65 years-old; had diagnoses of chronic insomnia according to the Insomnia Severity Index (ISI ≥ 8); had insomnia for more than 3 months. Twenty-five GPs and nurses and 32 patients were randomly allocated to two groups. The main outcome of the intervention was improvement of dimensions of sleep quality, measured using the Spanish version of the Pittsburgh Sleep Quality Index, at baseline and at 3 months after the intervention. Other primary outcomes of the study were the feasibility and applicability of the intervention, collected through nominal groups. A thematic analysis was performed to classify primary care provider (PCP) proposals. Additionally, we assessed the recruitment process, compliance with the intervention sessions, and patient retention. RESULTS: We adapted the CBT-i approach of Morin to a primary care context. After intervention training, PCPs expressed the need for more extensive training in the different aspects of the therapy and the discussion of more cases. PCPs considered the intervention as adequate but wanted fewer but longer sessions as well as to discard the cognitive restructuring component. PCPs considered it crucial to prepare each session in advance and to establish a specific agenda for the CBT-i. Regular reminders given to PCPs and patients were suggested to improve study participation. Compared to the UC group, higher proportions of patients in the intervention group had short sleep latency, slept for longer than 5 h, and had fewer sleep disruptions. CONCLUSIONS: This feasibility-pilot study identified several key issues that must be addressed before performing a CBT-i intervention in future clinical trial in a primary care setting. TRIAL REGISTRATION: NCT04565223 . (Clinical trials.gov) Registered 1 September 2020-Retrospectively registered.

Effectiveness of a multifactorial intervention, consisting of self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise, in patients with uncontrolled hypertension taking 2 or more antihypertensive drugs: The MEDICHY study.

INTRODUCTION: High blood pressure is the leading modifiable risk factor for cardiovascular disease, and is associated with high morbidity and mortality and with significant health care costs for individuals and society. However, fewer than half of the patients with hypertension receiving pharmacological treatment have adequate blood pressure control. The main reasons for this are therapeutic inertia, lack of adherence to treatment, and unhealthy lifestyle (i.e., excess dietary fat and salt, sedentary lifestyle, and overweight). Cardiovascular risk and mortality are greater in hypertensive patients who are receiving treatment but have suboptimal control of blood pressure. METHODS/DESIGN: This is a multicentre, parallel, 2-arm, single-blind (outcome assessor), controled, cluster-randomized clinical trial. General practitioners and nurses will be randomly allocated to the intervention group (self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise) or the control group (regular clinical practice). A total of 424 patients in primary care centers who use 2 or more antihypertensive drugs and blood pressure of at least 130/80 during 24-hambulatory blood pressure monitoring will be recruited. The primary outcome is systolic blood pressure at 12 months. The secondary outcomes are blood pressure control (<140/90 mm Hg); quality of life (EuroQol 5D); direct health care costs; adherence to use of antihypertensive medication; and cardiovascular risk (REGICOR and SCORE scales). DISCUSSION: This trial will be conducted in the primary care setting and will evaluate the impact of a multifactorial intervention consisting of self-management of blood pressure, antihypertensive medications, and lifestyle modifications (hypocaloric and low sodium diet and physical exercise).

Prevalencia de insomnio y características de la población insomne de una zona básica de salud de Mallorca (España) / Prevalence of insomnia and characteristic of patients with insomnia in a health area of Majorca (Spain)

Objetivos: Conocer la prevalencia de insomnio y los hábitos, comorbilidades, calidad del sueño y tratamiento de los pacientes insomnes. Diseño: Estudio descriptivo transversal. Emplazamiento: Centro de Atención Primaria de Calviá (Mallorca). Participantes: Sujetos entre 18-80 años con > 2 años de adscripción al Centro de Salud. Métodos: Se realizó una primera entrevista telefónica para cribado de insomnes mediante el Insomnia Severity Index. Los sujetos insomnes fueron entrevistados personalmente en el centro de salud para registrar el resto de variables. Resultados: De la muestra de 1.563 personas, contactamos con 591 y participaron 467. La prevalencia de insomnio fue del 21,1% (IC 95% 17,38-25,01) y de insomnio clínico del 6,9% (IC 95% 4,45-9,25). Fue más común en mujeres, viudos y divorciados, jubilados y desempleados. Dos tercios tenían sobrepeso-obesidad; un 37% dolor crónico, un 21,1% depresión y un 37,9% ansiedad. La mitad refería dificultades para realizar las actividades de la vida diaria y mantener un buen estado de ánimo. Asimismo, el 41,1% refería que habitualmente tomaba fármacos para dormir. Las medidas terapéuticas más utilizadas fueron la higiene del sueño y las benzodiacepinas; mientras que las terapias cognitivo-conductuales eran poco habituales. Conclusiones: La prevalencia de insomnes en nuestra zona es semejante a la esperada en estudios realizados en población general. La presencia de algunos hábitos perjudiciales para el sueño y las comorbilidades pueden favorecer la cronificación del insomnio, por lo que se debe considerar el manejo de esta patología en un contexto más amplio. Predomina el tratamiento farmacológico mientras que las terapias no farmacológicas de demostrada efectividad son muy ocasionales

Objectives: To estimate insomnia prevalence as well as habits comorbidity, sleep quality of insomnia patients. Design: Cross sectional descriptive study. Setting: Calvia health center (Majorca, Spain). Participants: We included subjects registered in a Health Center (> 2 years) of 18-80 years old. Methods: Firstly, they were interviewed by telephone in order to identify persons with insomnia using the Insomnia Severity Index. Afterward, subjects with insomnia were interviewed in the health center in order to collect the data. Results: From a simple of 1,563 persons, we contacted 591 and 467 participated. Insomnia prevalence was 21.1% (IC 95% 17.38-25.01) and 6.9% (IC 95% 4.45-9.25) clinical insomnia. It was significantly more frequent in women, widow, divorced, retired and unemployed. Two in three presented obesity or overweight, 37% chronic pain, 21.1% depression and 37.9% anxiety. Half of the patients with insomnia referred a negative impact on daily activities and difficulties to maintain enthusiasm. Moreover, 41.1% declared to take pharmacological treatment for sleep usually. The more common therapeutic measures for insomnia were sleep hygiene and benzodiazepines; while cognitive-behavioral therapies were rarely used. Conclusions: The prevalence of insomnia in our health area is similar to those described in population based studies. The presence of some prejudicial habits for sleep quality as well as comorbidities could facilitate insomnia to become a chronic illness. Then, management of insomnia should be considered in a patient more general context. Pharmacological treatment is still in the first line and effective non pharmacological treatment is still a rare option

[Prevalence of insomnia and characteristic of patients with insomnia in a health area of Majorca (Spain)]. / Prevalencia de insomnio y características de la población insomne de una zona básica de salud de Mallorca (España).

OBJECTIVES: To estimate insomnia prevalence as well as habits comorbidity, sleep quality of insomnia patients. DESIGN: Cross sectional descriptive study. SETTING: Calvia health center (Majorca, Spain). PARTICIPANTS: We included subjects registered in a Health Center (> 2 years) of 18-80 years old. METHODS: Firstly, they were interviewed by telephone in order to identify persons with insomnia using the Insomnia Severity Index. Afterward, subjects with insomnia were interviewed in the health center in order to collect the data. RESULTS: From a simple of 1,563 persons, we contacted 591 and 467 participated. Insomnia prevalence was 21.1% (IC 95% 17.38-25.01) and 6.9% (IC 95% 4.45-9.25) clinical insomnia. It was significantly more frequent in women, widow, divorced, retired and unemployed. Two in three presented obesity or overweight, 37% chronic pain, 21.1% depression and 37.9% anxiety. Half of the patients with insomnia referred a negative impact on daily activities and difficulties to maintain enthusiasm. Moreover, 41.1% declared to take pharmacological treatment for sleep usually. The more common therapeutic measures for insomnia were sleep hygiene and benzodiazepines; while cognitive-behavioral therapies were rarely used. CONCLUSIONS: The prevalence of insomnia in our health area is similar to those described in population based studies. The presence of some prejudicial habits for sleep quality as well as comorbidities could facilitate insomnia to become a chronic illness. Then, management of insomnia should be considered in a patient more general context. Pharmacological treatment is still in the first line and effective non pharmacological treatment is still a rare option.

Evidencias disponibles sobre las propiedades médicas del calzado tipo Masai / Available evidence on the medical properties of Masai type footwear

No diponible