Feasibility and Acceptability of Personalized Breast Cancer Screening (DECIDO Study): A Single-Arm Proof-of-Concept Trial.

The aim of this study was to assess the acceptability and feasibility of offering risk-based breast cancer screening and its integration into regular clinical practice. A single-arm proof-of-concept trial was conducted with a sample of 387 women aged 40-50 years residing in the city of Lleida (Spain). The study intervention consisted of breast cancer risk estimation, risk communication and screening recommendations, and a follow-up. A polygenic risk score with 83 single nucleotide polymorphisms was used to update the Breast Cancer Surveillance Consortium risk model and estimate the 5-year absolute risk of breast cancer. The women expressed a positive attitude towards varying the frequency of breast screening according to individual risk and, especially, more frequently inviting women at higher-than-average risk. A lower intensity screening for women at lower risk was not as welcome, although half of the participants would accept it. Knowledge of the benefits and harms of breast screening was low, especially with regard to false positives and overdiagnosis. The women expressed a high understanding of individual risk and screening recommendations. The participants' intention to participate in risk-based screening and satisfaction at 1-year were very high.

[Moving toward personalized breast cancer screening: The role of Primary Care]. / Avances hacia el cribado personalizado del cáncer de mama: el papel de la Atención Primaria.

Breast cancer is the leading cause of death in the world among women. The Spanish National Health System (SNHS) introduced population-based breast cancer screening in 1990. As in most European programs, risk is identified on the basis of age and a mammogram is offered every two years to women aged 50-69 years. Scientific evidence is moving toward personalized screening, based on individual risk. This article presents the clinical trials that will evaluate the efficacy of personalized screening and some studies carried out in our environment on the effect of informing women of the benefits and adverse effects of screening or the acceptability and feasibility of offering personalized screening, in the Shared Decision Making context. The Preventive Activities and Health Promotion Program can help transform screening in our SNHS.

Feasibility Assessment of the Let's Walk Programme (CAMINEM): Exercise Training and Health Promotion in Primary Health-Care Settings.

Exercise is related to many individual health outcomes but impact evaluations of exercise programmes are seldom conducted. The purpose of the study is to evaluate the feasibility of an exercise prescription intervention in primary health-care settings (CAMINEM Programme) located in two socially disadvantaged neighbourhoods. The CAMINEM was a pragmatic-driven intervention with opportunistic recruitment. It followed the 5As framework for health promotion and also the exercise training principles. Feasibility was evaluated using the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance). Patients with non-communicable chronic diseases participated in a 12-month home-based moderate-intensity exercise program, counselled by exercise physiologists. Participants were grouped according to their physical activity behaviour at baseline and 6-month adherence. CAMINEM reached 1.49% (n = 229) of the eligible population (N = 15374) and included a final sample of 178. Health outcomes for adhered participants followed positive patterns. Non-adhered participants visited their practitioner more compared to adhered participants. Thirty-three practitioners (40%) referred patients. Nurses referred four times more than physicians (81% and 19% respectively). The delivery of exercise prescriptions proved to be easy to complete and record by participants as well as easy to monitor and adjust by the exercise physiologists. One out of four participants adhered during the 12-month intervention. This intervention has been feasible in primary care in Catalonia, Spain, to safely prescribe home-based exercise for several conditions.

Feasibility and acceptability of personalised breast cancer screening (DECIDO study): protocol of a single-arm proof-of-concept trial.

INTRODUCTION: Personalised cancer screening aims to improve benefits, reduce harms and being more cost-effective than age-based screening. The objective of the DECIDO study is to assess the acceptability and feasibility of offering risk-based personalised breast cancer screening and its integration in regular clinical practice in a National Health System setting. METHODS AND ANALYSIS: The study is designed as a single-arm proof-of-concept trial. The study sample will include 385 women aged 40-50 years resident in a primary care health area in Spain. The study intervention consists of (1) a baseline visit; (2) breast cancer risk estimation; (3) a second visit for risk communication and screening recommendations based on breast cancer risk and (4) a follow-up to obtain the study outcomes.A polygenic risk score (PRS) will be constructed as a composite likelihood ratio of 83 single nucleotide polymorphisms. The Breast Cancer Surveillance Consortium risk model, including age, race/ethnicity, family history of breast cancer, benign breast disease and breast density will be used to estimate a preliminary 5-year absolute risk of breast cancer. A Bayesian approach will be used to update this risk with the PRS value.The primary outcome measures will be attitude towards, intention to participate in and satisfaction with personalised breast cancer screening. Secondary outcomes will include the proportions of women who accept to participate and who complete the different phases of the study. The exact binomial and the Student's t-test will be used to obtain 95% CIs. ETHICS AND DISSEMINATION: The study protocol was approved by the Drug Research Ethics Committee of the University Hospital Arnau de Vilanova. The trial will be conducted in compliance with this study protocol, the Declaration of Helsinki and Good Clinical Practice.The results will be published in peer-reviewed scientific journals and disseminated in scientific conferences and media. TRIAL REGISTRATION NUMBER: NCT03791008.

Efficacy and safety of topical application of 15% and 10% potassium hydroxide for the treatment of Molluscum contagiosum.

BACKGROUND/OBJECTIVES: Molluscum contagiosum is the most common skin infection in children. One topical treatment used for Molluscum contagiosum is potassium hydroxide. The objective of this study was to compare the efficacy of potassium hydroxide topical treatment at different concentrations with that of placebo in terms of complete clearing of Molluscum contagiosum lesions and to assess the safety and tolerance of potassium hydroxide topical treatment. METHODS: This was a double-blind randomized clinical trial of three treatments (potassium hydroxide 10%, potassium hydroxide 15%, placebo) applied once daily up to complete clearing of lesions (maximum duration 60 days) in 53 children aged 2-6 years in primary health care pediatric offices in Catalonia, Spain. RESULTS: In the intention-to-treat analysis, potassium hydroxide 10% (58.8%, P = .03) and potassium hydroxide 15% (64.3%, P = .02) had efficacy superior to that of placebo (18.8%). The number of Molluscum contagiosum lesions was significantly reduced with potassium hydroxide 10% and 15%. The main efficacy outcome was achieved in 58.8% of children in the potassium hydroxide 10% group (P = .03 vs placebo) and in 64.3% of children in the potassium hydroxide 15% group (P = .02 vs placebo). Potassium hydroxide 10% and 15% were not significantly different in efficacy from each other. Potassium hydroxide 10% and placebo were better tolerated than potassium hydroxide 15%. No adverse events were reported during the study period. CONCLUSIONS: Potassium hydroxide 10% and 15% demonstrated high rates of efficacy in clearing Molluscum contagiosum lesions, with potassium hydroxide 10% being better tolerated.

[Potentially inappropriate prescribing in older Spanish population according to STOPP/START criteria (STARTREC study)]. / Análisis poblacional de la prescripción potencialmente inadecuada en ancianos según criterios STOPP/START (estudio STARTREC).

OBJECTIVE: Rational prescribing in older people is a priority for health care organizations. The STOPP/START screening tool has been developed to identify potentially inappropriate prescribing (PIP) in individuals. In a primary care setting, STOPP/START can estimate PIP prevalence and related factors at population level. The aim of this study is to measure the prevalence rates of PPI in elderly population using clinical and prescription claim databases. DESIGN: Cross-sectional population study. SETTINGS: Primary Care, Lleida Health Region, Spain. PARTICIPANTS: 45.408 patients 70 years old and over, attended in the primary health care centers at least once the last year. METHODS: 43 STOPP and 12 START criteria are applied to their 2012 clinical and prescription records. Logistic regression models are adjusted to determine PIP association with several factors. RESULTS: 45,408 patients are included. The mean age is 79.7 years, 58% being female. The overall prevalence of PPI is 58.1%. According to STOPP, the most common drugs identified are benzodiazepines, non-steroidal anti-inflammatory drugs and proton pump inhibitors; according to START, osteoporosis treatments, antiplatelet agents, statins, metformin and beta blockers. PIP increases with age and polypharmacy and it is higher in long-term care facilities residents and patients receiving home health care. CONCLUSIONS: In our Health Region, at least 50% of the population aged 70 or older has one or more PIP, according to STOPP/START criteria.

Effectiveness of a Multi-Component Intervention for Overweight and Obese Children (Nereu Program): A Randomized Controlled Trial.

INTRODUCTION: Treatment of childhood obesity is a complex challenge for primary health care professionals. OBJECTIVES: To evaluate the effectiveness of the Nereu Program in improving anthropometric parameters, physical activity and sedentary behaviours, and dietary intake. METHODS: Randomized, controlled, multicentre clinical trial comparing Nereu Program and usual counselling group interventions in primary care settings. The 8-month study recruited 113 children aged 6 to 12 years with overweight/obesity. Before recruitment, eligible participants were randomly allocated to an intensive, family-based multi-component behavioural intervention (Nereu Program group) or usual advice from their paediatrician on healthy eating and physical activity. Anthropometric parameters, objectively measured sedentary and physical activity behaviours, and dietary intake were evaluated pre- and post-intervention. RESULTS: At the end of the study period, both groups achieved a similar decrease in body mass index (BMIsd) compared to baseline. Nereu Program participants (n = 54) showed greater increases in moderate-intense physical activity (+6.27% vs. -0.61%, p<0.001) and daily fruit servings (+0.62 vs. +0.13, p<0.026), and decreased daily soft drinks consumption (-0.26 vs. -0.02, p<0.047), respectively, compared to the counselling group (n = 59). CONCLUSIONS: At the end of the 8-month intervention, participants in the Nereu Program group showed improvement in physical activity and dietary behaviours, compared to the counselling group. TRIAL REGISTRATION: ClinicalTrials.gov NCT01878994.

[Heart failure patients in Primary Care: aging, comorbidities and polypharmacy]. / Pacientes con el diagnóstico de insuficiencia cardiaca en Atención Primaria: envejecimiento, comorbilidad y polifarmacia.

OBJECTIVE: To assess heart failure prevalence, epidemiology, co-morbidities and polypharmacy in our region from electronic patient records. To evaluate gender differences in heart failure patients. DESIGN: Descriptive, cross-sectional study. SETTING: Primary care Lleida (Spain). PARTICIPANTS: All patients from 21 primary care centers with the diagnosis of heart failure in medical records were included. MAIN OUTCOME MEASUREMENTS: Demographic data, comorbidities and therapeutical subgroups in patients with a diagnosis of heart failure in their clinical record. RESULTS: Heart failure was found in 0.99% (3017 from 306229 patients), of whom 59% were women, and a mean age of 80 years. Comorbidities: hypertension 67%, diabetes 30%, hyperlipidemia 26.5%, obesity 27%, ischemic heart disease 19%, stroke 11%, atrial fibrillation 31%, COPD 26%, renal failure 12%. Hypertension, hyperlipidemia and obesity were more frequent in women, COPD, ischemic heart disease and renal failure in men. There were no differences in diabetes, stroke and atrial fibrillation. Patients were prescribed a median of 8 different therapeutic subgroups (P25=6 and P75=11). Women were more frequently prescribed diuretics (76%), cardiac glycosides (22%) and ACE inhibitors/angiotensin II receptor antagonists, and men ACE inhibitors/angiotensin II receptor antagonists in combination with beta-blockers. CONCLUSIONS: Heart failure patients in primary care are elderly, with significant co-morbidities and treated with a high number of drugs. Gender differences exist in cardiovascular risk factors, co-morbidities, and also in therapy.