[Vulnerability of obesity as defined by body mass index, waist circumference, and body fat percentage]. / Vulnerabilidad de la obesidad definida por el índice de masa corporal, perímetro abdominal y porcentaje de grasa corporal.

AIM: To ascertain to what extent it is possible to stop being obese (to normalize body mass index [BMI], waist circumference [WC] and/or body fat percentage [BFP]). DESIGN: Longitudinal observational and retrospective study. SITE: Eleven Spanish health centers. PARTICIPANTS: Men and women with BMI≥30kg/m2 (n=1246) or general obesity (GO), with WC>102cm and >88cm, respectively (n=2122) or abdominal obesity (AO) and with BFP>25% and >35%, respectively (n=2436) or excess body fat (EBF), from the PEPAF Study cohort of 4927 participants aged 20-80years. MAIN MEASUREMENTS: Data from the PEPAF study at baseline and at 6, 12 and 24months: gender, age, diagnoses of diabetes, hypertension and dyslipidemia, smoking, levels of and compliance with physical activity recommendations, maximum oxygen consumption, weigh, height, WC and three skin-folds (thoracic, umbilical and anterior thigh for men and triceps, suprailiac and anterior thigh for women). RESULTS: Of 2054 participants with any type of obesity at baseline and valid data at 2years, 240 (11.6%) had normalized all of their obesity diagnostic indexes. 19.5% (95% confidence interval (95%CI: 17.6-21.4) ceased to have EBF, 12.0% (95%CI: 10.4-13.7) ceased to have AO and 10.5% (95%CI: 8.5-12.7) ceased to have GO. CONCLUSIONS: Obesity differs from other chronic diseases in that it can be «cured¼ by normalizing the amount of body fat.

[Barriers and facilitators of the EfiKroniK exercise program for people with chronic diseases in Primary Care]. / Barreras y facilitadores del programa de ejercicio EfiKroniK para pacientes con enfermedad crónica en atención primaria.

OBJECTIVE: Explore patients' perceptions during a supervised exercise program and detect the barriers and facilitators that influence exercise adherence after the supervision period. DESIGN: A qualitative observational study with three focus groups as the main data collection technique was conducted. SITE: Primary Health centers of Bizkaia. PARTICIPANTS: Out of the 175 randomized patients in the hybrid effectiveness-implementation trial, a sample of 19 patients from the intervention group were included in the qualitative study (12 advanced-stage onco-haematological patients and seven with severe mental disorders). METHODS: Content analysis of the generated transcripts was performed by combining a deductive approach, based on the domains of the PRACTIS theoretical framework, and an inductive one, based on the postulates of the Grounded Theory. RESULTS: The data analysis showed that participants were satisfied with the EfiKroniK program and that the main identified benefits were discovery of the benefits of physical exercise, the psychological and emotional management of the disease, the benefits from peer communication and emotional support, and the break from routine of their illness. Participants decreased the levels of physical exercise at the end of the supervision6 due to the confluence of several barriers. CONCLUSION: A supervised exercise program carried out in Primary Care contributed to the improvement of the quality of life as well as the emotional and social well-being of patients with advanced-stage diseases. Our study identified potential barriers and facilitators associated with exercise participation and its continuity, however, it is necessary to encourage inter-sectoral coordination within the socio-health system to promote integrated and continuous care for chronic patients.

Fidelity evaluation of the compared procedures for conducting the PVS-PREDIAPS implementation strategy to optimize diabetes prevention in primary care.

BACKGROUND: Assessing the fidelity of an implementation strategy is important to understand why and how the strategy influences the uptake of evidence-based interventions. The present study aims to assess the fidelity of the two procedures for engaging primary care (PC) professionals and for the deployment of an implementation strategy for optimizing type 2 diabetes prevention in routine PC within the PREDIAPS randomized cluster implementation trial. METHOD: We conducted a mixed-method fidelity evaluation study of the PVS-PREDIAPS implementation strategy. Nine PC centers from the Basque Health Service (Osakidetza) were allocated to two different procedures to engage physicians and nurses and deploy a implementation strategy to model and adapt the clinical intervention and its implementation to their specific contexts: a Global procedure, promoting the cooperation of all healthcare professionals from the beginning; or a Sequential procedure, centered first on nurses who then pursued the pragmatic cooperation of physicians. Process indicators of the delivery and receipt of implementation strategy actions, documented modifications to the planned implementation strategy, and a structured group interview with centers' leaders were all used to assess the following components of fidelity: adherence, dose, quality of delivery, professionals' responsiveness and program differentiation. RESULTS: Generally, the procedures compared for professionals engagement and deployment of the implementation strategy were carried out with the planned differentiation. Nonetheless, some unexpected between-group differences were observed, the initial rate of collaboration of nurses being higher in the Sequential (93%) than in the Global (67%) groups. Exposure rate to the programed implementation actions (% of hours received out of those delivered) were similar in both groups by professional category, with nurses (86%) having a higher rate of exposure than physicians (75%). Professionals identified half of the planned discrete strategies and their rating of strategies' perceived usefulness was overwhelmingly positive, with few differences between Sequential and Global centers. CONCLUSIONS: The PVS-PREDIAPS implementation strategy has been implemented with high fidelity and minor unplanned reactive modifications. Professionals' exposure to the implementation strategy was high in both groups. The centers' organizational context (i.e., work overload) led to small mismatches between groups in participation and exposure of professionals to implementation actions. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT03254979 . Registered 16 August 2017.

Effectiveness of physical exercise for people with chronic diseases: the EFIKRONIK study protocol for a hybrid, clinical and implementation randomized trial.

BACKGROUND: Chronic illnesses are the leading cause of morbidity and mortality and threaten the sustainability of healthcare systems worldwide. There is limited evidence in terms of the best modality and intensity of physical activity for improving cardiorespiratory capacity and quality of life in patients with chronic conditions. The objective of the EfiKroniK study is to estimate the common effect of innovative, individualized and supervised physical exercise, on cardiorespiratory functional capacity and quality of life across people with different chronic conditions. METHODS/DESIGN: This is a multicentre clinical trial with a type I hybrid effectiveness-implementation design, including 370 patients each with one of four different chronic illnesses: solid cancer, blood cancer, chronic obstructive pulmonary disease or schizophrenia. Patients will be randomly divided into two parallel groups, stratified by illness type. Patients in both groups will receive a standard healthy life prescription (PVS, from the Spanish "Prescribe Vida Saludable") and additionally, the EfiKroniK group will be prescribed a physical exercise programme tailored to each patient in terms of intensity in each session. The primary outcome variables will be cardiorespiratory functional capacity and quality of life. The secondary outcome variables will be signs and symptoms, psychological and social factors and specific laboratory parameters. We will also analyse the dose-response effect of the physical exercise programme. Qualitative variables will describe patients' perception of the utility and suitability of the EfiKroniK programme, as well as their expectations and satisfaction, identifying barriers to and facilitators of the EfiKroniK implementation process through discussion groups. The study will be carried out on an intention-to-treat basis, comparing changes throughout the 1-year follow-up between groups, adjusting for baseline, by performing mixed-effect analysis of covariance. We will estimate the effect of time on repeated measures in each subject and changes in the EfiKroniK and PVS groups over time. DISCUSSION: The study will provide the data necessary to allow us to prescribe physical exercise in a similar way to a drug and as a key part of the treatment of chronic illnesses within our healthcare system. TRIAL REGISTRATION: NCT03810755 . Date and version identifier: October 9, 2020. Version2.0.

Cardiorespiratory fitness and development of abdominal obesity.

Both, cardiorespiratory fitness and abdominal obesity are independently associated with developing cardiovascular disease and its risk factors. However, the relationship between both attributes is unclear. We examine the relationship between cardiorespiratory fitness and the risk of developing abdominal obesity, and secondarily, other adiposity measures. Retrospective observational study of a cohort of 1284 sedentary patients, who had participated in a clinical trial of physical activity promotion carried out in Spain (2003-2007). At baseline, they were free of cardiovascular disease, hypertension, diabetes, dyslipidemia and/or abdominal obesity, with an indirect VO2max measurement, were 19-80 years old, 62% women, and had completed the two year follow-up. The exposure factor was cardiorespiratory fitness categorized as high, moderate or low, according to tertiles of VO2max values. The main outcome measure was the risk of developing abdominal obesity, as defined by waist circumference >102 (men) and >88 (women) cm. Secondary outcomes were the risk of developing: general obesity, excess body fat, and their combination ("defined" obesity). At two years, 10.5% of the participants had developed abdominal obesity: 6.1% in the high cardiorespiratory fitness tertile, 9.7% in the moderate tertile (adjusted odds ratio, 1.20; 95% confidence interval 0.68-2.10), and 15.7% in the low tertile (adjusted odds ratio, 2.29; 95% confidence interval 1.34-3.91). Moreover, 2.2% of participants in the high cardiorespiratory fitness tertile developed "defined" obesity as did 5.4% in the low tertile (adjusted odds ratio, 2.90; 95% confidence interval 1.15-7.29). Low cardiorespiratory fitness levels are associated with a higher risk of developing abdominal and "defined" obesity.

Consensus on priorities in maternal education: results of Delphi and nominal group technique approaches.

BACKGROUND: Maternal education is wide-ranging and covers many areas from pregnancy to the immediate postpartum period and childrearing. However, for it to be effective, more resources need to be assigned to key topics. The goal of this study was to identify and prioritize the most important issues in maternal education, so that specific objectives could subsequently be set and learning outcomes evaluated. METHODS: We drew up a comprehensive list of topics addressed in existing maternal education programs, based on a systematic review of information obtained from the Internet and the experience of the research team. The topics were presented to a multidisciplinary panel whose members were asked to rate them from 1 to 9, and consensus of opinion was reached using a two-round Delphi survey, with consensus defined beforehand as 80% agreement among panelists in awarding a score of 7, 8 or 9. The most highly-rated topics were then discussed and again prioritized by a multidisciplinary team of healthcare and non-healthcare experts, using a nominal group technique. RESULTS: Initially, 650 topics were identified and grouped into 80 categories which were then prioritized by 54 healthcare and non-healthcare experts using a Delphi survey with a study participation rate of around 20%. 63 topics were considered very important, so criteria were restricted and only the 24 highest-scoring selected (95% of agreement on scores ≥7 or 80% of agreement on scores ≥8). Using the nominal group technique, a group of 12 experts identified the following priorities: initiation and establishment of breastfeeding, development of a birth plan, identification of problems and self-care postpartum, nutrition and a healthy lifestyle, options for pain management in labor and birth and characteristics of a normal newborn/looking after a newborn baby. CONCLUSION: This study, with a Delphi study and the Consensus among Experts: the nominal group technique, has succeeded in identifying priority topics in maternal education. We need to assess women's needs in relation to these topics, design an intervention to respond to these needs and evaluate its effectiveness.

Needle tenotomy with PRP versus lidocaine in epicondylopathy: clinical and ultrasonographic outcomes over twenty months.

OBJECTIVE: To investigate whether pathological changes in elbow epicondylopathy, as assessed by conventional ultrasonography and clinical outcomes, could be modified following tenotomy with platelet-rich plasma (PRP) versus tenotomy with lidocaine. METHODS: This prospective sub-study was part of a patient- and assessor-blinded, superiority-type, randomized, lidocaine-controlled trial that was performed in a tertiary hospital to assess the effectiveness of PRP versus lidocaine as tenotomy adjuvants in patients with epicondylopathy. Patients were followed after two sessions of tenotomy with either PRP or lidocaine adjuvants (4 ml) within a 2-week interval. Tendon thickness, echotexture, and neovascularization were assessed as secondary outcome measurements at baseline and at 3, 6, 12, and 20 months after treatment, and correlations with clinical outcomes were examined. RESULTS: Twenty months after treatment, tenotomy induced changes in tendon structure, thickness (± = 0.0006), vascularity (p < 0.0001), and echotexture (p < 0.0001). In Disabilities of the Arm, Shoulder and Hand (DASH-E) and pain (VAS-P) scores, 80.85% and 90.91% of patients showed a meaningful clinical improvement, respectively, without differences between PRP and lidocaine. There were significant differences in between-group changes in vascularity over time, p = 0.037 and p = 0.049 in the unadjusted and adjusted models, respectively. There was no relationship between pain or function and sonographic entities at the various time points. CONCLUSIONS: Two successive needle tenotomies induced structural changes in recalcitrant epicondylopathy, with PRP displaying more vascularization and increased thickness over time compared to lidocaine. PRP compared with lidocaine did not result in improved function or decreased pain over 20 months.

Autologous platelet-rich plasma in the treatment of venous leg ulcers in primary care: a randomised controlled, pilot study.

OBJECTIVE: To examine the potential efficacy and safety of autologous platelet-rich plasma (PRP) in comparison with the conventional treatment (standard care, SoC) for the treatment of leg ulcers in patients with chronic venous insufficiency, in a primary health-care setting. METHOD: A Phase I-II, open-label, parallel-group, multicentre, randomised pilot study was conducted. The outcome variables at baseline and at weeks five and nine included reduction in the ulcer area, Chronic Venous Insufficiency Quality of Life Questionnaire score, cost of the treatment for up to nine weeks and average weekly cure rate. RESULTS: A total of eight patients, each with at least a six-month history of venous leg ulcer (VLUs), were included in the study. A total of 12 ulcers were treated with either autologous PRP or standard SoC. Patients treated with PRP required wound care only once per week. In the SoC group, patients required intervention 2-3 times per week. A reduction in the mean ulcer size in the PRP group was 3.9cm2 compared with the SoC group at 3.2cm 2 , although the sample size was insufficient to reach statistical significance. Improvement in quality of life (QoL) score was observed in the patients in the PRP group. CONCLUSION: This study offers proof-of-concept of the feasibility and safety of PRP treatment to inform larger clinical trials in patients with VLUs. Our preliminary results suggest that PRP delivers a safe and effective treatment for VLU care that can be implemented in primary health-care settings.

Framework for the establishment of a feasible, tailored and effective perinatal education programme.

BACKGROUND: Antenatal education needs to be renewed and adapted to the needs of women. OBJECTIVES: to assess women needs, identify factors that influence the desired outcomes, and propose a framework for developing new perinatal education based on the guidance published by the UK Medical Research Council for the development and evaluation of complex interventions in primary care. METHODS: For this study: (a) four focus group sessions were held from October to November 2010 in Bizkaia (Spain) with 30 women exploring their needs during pregnancy and postpartum; (b) two literature reviews were conducted on women's needs at these times and theoretical models of healthcare education; and (c) seven discussion and consensus sessions were run with a group of experts composed of midwifes, gynaecologists, paediatricians, and paediatric and postpartum nurses. RESULTS: Various areas for improvement were identified: needs assessment of each woman/family, consideration of pregnancy and childbirth as normal physiological processes, participation of fathers, establishment of social networks, continuity of postpartum care, better access to and training for midwives, and more flexible format and contents for the programme. We propose a woman-focused framework that includes three exploratory interviews during pregnancy, personalized interventions coordinated between professionals, empowerment to choose the type of birth, and postpartum activities. CONCLUSION: New perinatal education should be on-going and focused on each woman. It is necessary to assess the feasibility of implementing this type of programme, depending on the context, professionals' readiness for change and characteristics of the proposed interventions. Then, its effectiveness and sustainability must be assessed.

The implementation of health promotion in primary and community care: a qualitative analysis of the 'Prescribe Vida Saludable' strategy.

BACKGROUND: The impact of lifestyle on health is undeniable and effective healthy lifestyle promotion interventions do exist. However, this is not a fundamental part of routine primary care clinical practice. We describe factors that determine changes in performance of primary health care centers involved in piloting the health promotion innovation 'Prescribe Vida Saludable' (PVS) phase II. METHODS: We engaged four primary health care centers of the Basque Healthcare Service in an action research project aimed at changing preventive health practices. Prescribe Healthy Life (PVS from the Spanish "Prescribe Vida Saludable) is focused on designing, planning, implementing and evaluating innovative programs to promote multiple healthy habits, feasible to be performed in routine primary health care conditions. After 2 years of piloting, centers were categorized as having high, medium, or low implementation effectiveness. We completed qualitative inductive and deductive analysis of five focus groups with the staff of the centers. Themes generated through consensual grounded qualitative analysis were compared between centers to identify the dimensions that explain the variation in actual implementation of PVS, and retrospectively organized and assessed against the Consolidated Framework for Implementation Research (CFIR). RESULTS: Of the 36 CFIR constructs, 11 were directly related to the level of implementation performance: intervention source, evidence strength and quality, adaptability, design quality and packaging, tension for change, learning climate, self-efficacy, planning, champions, executing, and reflecting and evaluating, with -organizational tracking added as a new sub-construct. Additionally, another seven constructs emerged in the participants' discourse but were not related to center performance: relative advantage, complexity, patients' needs and resources, external policy and incentives, structural characteristics, available resources, and formally appointed internal implementation leaders. Our findings indicate that the success of the implementation seems to be associated with the following components: the context, the implementation process, and the collaborative modelling. CONCLUSIONS: Identifying barriers and enablers is useful for designing implementation strategies for health promotion in primary health care centers that are essential for innovation success. An implementation model is proposed to highlight the relationships between the CFIR constructs in the context of health promotion in primary care.

Feasibility of an implementation strategy for the integration of health promotion in routine primary care: a quantitative process evaluation.

BACKGROUND: Process evaluation is recommended to improve the understanding of underlying mechanisms related to clinicians, patients, context and intervention delivery that may impact on trial or program results, feasibility and transferability to practice. The aim of this study was to assess the feasibility of the Prescribe Healthy Life (PVS from the Spanish "Prescribe Vida Saludable") implementation strategy for enhancing the adoption and implementation of an evidence-based health promotion intervention in primary health care. METHODS: A descriptive study of 2-year implementation indicators for the PVS clinical intervention was conducted in four primary health care centers. A multifaceted collaborative modeling implementation strategy was developed to enhance the integration of a clinical intervention to promote healthy lifestyles into clinical practice. Process indicators were assessed for intervention reach, adoption, implementation, sustainability and their variability at center, practice, and patient levels. RESULTS: Mean rates of adoption by means of active collaboration among the three main professional categories (family physicians, nurses and administrative personnel) were 75% in all centers. Just over half of the patients that attended (n = 11650; 51.9%) were reached in terms of having their lifestyle habits assessed, while more than a third (33.7%; n = 7433) and almost 10% (n = 2175) received advice or a printed prescription for at least one lifestyle change, respectively. Only 3.7% of the target population received a repeat prescription. These process indicators significantly (p < 0.001) varied by center, lifestyle habit and patient characteristics. Sustainability of intervention components changed thorough the implementation period within centers. CONCLUSIONS: The implementation strategy used showed moderate-to-good performance on process indicators related to adoption, reach, and implementation of the evidence-based healthy lifestyle promotion intervention in the context of routine primary care. Sources of heterogeneity and instability in these indicators may improve our understanding of factors required to attain adequate program adoption and implementation through improved implementation strategies.

Metric properties of the "prescribe healthy life" screening questionnaire to detect healthy behaviors: a cross-sectional pilot study.

BACKGROUND: Feasible and valid assessment of healthy behaviors is the first step for integrating health promotion in routine primary care. Therefore, the aim of this study was to develop and evaluate the validity and reliability of the "prescribe healthy life" screening questionnaire, a brief tool for detecting physical activity levels, consumption of fruit and vegetables, tobacco use and patients' compliance with minimal recommendations. METHODS: An observational cross-sectional study to determine the reliability and validity of this questionnaire by means of mixed (qualitative and quantitative) methods. Thirteen healthcare professionals designed the questionnaire. One hundred and twenty-six patients from three primary care health centers within Osakidetza (Basque Health Service, Spain) filled in the "Prescribe Healthy Life" Screening Questionnaire and completed an accelerometry record, the PREDIMED Food Frequency Questionnaire and a co-oximetry as gold standards for physical activity, dietary intake and tobacco use, respectively. Correlations, sensitivities, specificities, likelihood ratios and test-retest reliability were calculated. Additionally, the feasibility and utility of the questionnaire were evaluated. RESULTS: Both reliability and concurrent validity for the consumption of fruit and vegetables (rspearman = 0.59, rspearman = 0.50) and tobacco use (rspearman = 0.76, r = 0.69) as their overall performance in the detection of unhealthy diet (accuracy = 76.8%, LR + = 3.1 and LR- = 0.31) and smokers (accuracy = 86.8%, LR + = 6.1 and LR- = 0.05) were good. Meanwhile, the reproducibility (0.38), the correlation between the minutes of physical activity (0.34) and LR+ (1.00) for detection of physical activity were low. On average the questionnaire was considered by patients easy to understand, easy to fill in, short (5-6 min) and useful. CONCLUSION: The "Prescribe Healthy Life" Screening Questionnaire, PVS-SQ, has proved to be a simple and practical tool for use in the actual context of primary care, with guarantees of validity and reliability for the diet and tobacco scales. However, the physical activity scale show unsatisfactory results, and alternative questions ought to be tested.

[Perceived needs of women regarding maternity. Qualitative study to redesign maternal education]. / Necesidades percibidas por las mujeres respecto a su maternidad. Estudio cualitativo para el rediseño de la educación maternal.

OBJECTIVES: To assess women's perceptions of their needs during the process of becoming a mother and identify what they want from maternal education. DESIGN: Qualitative study with focus groups. SETTING: Bizkaia health region, Basque Health Service (Osakidetza), Spain. PARTICIPANTS: Thirty one women were recruited consecutively by midwives at six Osakidetza health centres. METHODS: Four sessions were held from September to November 2010 in Bizkaia (Spain), the four groups being stratified by socioeconomic status and stage of the process (pregnancy vs. postnatal period). To collate the information related to the various topics discussed, we used manifest content analysis that was facilitated by use of ATLAS.ti software. RESULTS: The focus of the women worries changes over time. In early pregnancy, women's main concern was for "everything to go well". As the pregnancy progressed, they needed more emotional support and wanted to feel confident and be self-reliant to face their fears of the birth and care for their child. They needed greater accompaniment in the puerperium and less pressure concerning breastfeeding. They also wanted an extended programme of perinatal rather than just antenatal education, which was more participatory and flexible and greater participation of their partner. CONCLUSION: Women have the same social and family networks needs, regardless of cultural differences between Anglo-Saxon and Southern European countries. We recommend an perinatal education to empower women to manage their own health and that of their family and link the health system with other networks of personal and social support for women.

Supervised physical exercise to improve the quality of life of cancer patients: the EFICANCER randomised controlled trial.

BACKGROUND: The optimal form of exercise for individuals with cancer has yet to be identified, but there is evidence that exercise improves their quality of life. The aim of this study is to assess the efficacy and efficiency of an innovative physical exercise programme, for individuals undergoing chemotherapy for breast, gastrointestinal or non-small cell lung tumours, for improving quality of life, reducing level of fatigue, and enhancing functional capacity over time. DESIGN/METHODS: We will conduct a clinical trial in 66 patients with stage IV breast, gastrointestinal or non-small cell lung cancer, recruited by the Department of Oncology of the referral hospital from 4 primary care health centres of the Basque Health Service (Osakidetza). These patients will be randomised to one of two groups. The treatment common to both groups will be the usual care for cancer: optimized usual drug therapies and strengthening of self-care; in addition, patients in the intervention group will participate in a 2-month exercise programme, including both aerobic and strength exercises, supervised by nurses in their health centre. The principal outcome variable is health-related quality of life, measured blindly with the 30-item European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire and Short Form-36 four times: at baseline, and 2, 6 and 12 months later. The secondary outcome variables are fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire), functional capacity (6-Minute Walk Test and cardiorespiratory test), muscle strength (hand-held dynamometry and sit-to-stand test), radiological response to treatment (Response Evaluation Criteria In Solid Tumors) and progression-free and overall survival. Age, sex, diagnosis, chemotherapy regimen, Eastern Cooperative Oncology Group performance status and smoking status will be considered as predictive variables. Data will be analysed on an intention-to-treat basis, comparing changes at each time point between groups, adjusting for baseline values by analysis of covariance. DISCUSSION: As well as achieving the objectives set, this study will provide us with information on patient perception of the care received and an opportunity to develop a project based on collaborative action between the primary care and oncology professionals. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01786122 Registration date: 02/05/2013.

Effectiveness of physical activity promotion interventions in primary care: A review of reviews.

OBJECTIVE: The present review aims to summarize the evidence about the effectiveness of physical activity (PA) promotion interventions in primary care (PC) and the intervention or sample characteristics associated with greater effectiveness. METHODS: MEDLINE, EMBASE, and Cochrane Library were searched to identify systematic reviews and meta-analyses published from 2002 to 2012 that assessed the effectiveness of PA-promoting interventions in PC. Information was extracted and recorded about each of the selected studies and their reported results. Methodological and evidence quality was independently rated by two reviewers using the nine-item OQAQ scale and the SIGN classification system. RESULTS: Ten of the 1664 articles identified met the inclusion criteria: five meta-analyses, three systematic reviews, and two literature reviews. Overall, PA promotion interventions in PC showed a small to moderate positive effect on increasing PA levels. Better results were obtained by interventions including multiple behavioral change techniques and those targeted to insufficiently active patients. No clear associations were found regarding intervention intensity or sample characteristics. CONCLUSION: Although several high-quality reviews provided clear evidence of small but positive effects of PA intervention in PC settings, evidence of specific strategies and sample characteristics associated with greater effectiveness is still needed to enhance the implementation of interventions under routine clinical conditions.

Evidence from interventions based on theoretical models for lifestyle modification (physical activity, diet, alcohol and tobacco use) in primary care settings: A systematic review.

OBJECTIVE: To determine the effectiveness of health promotion interventions based on theoretical models of behavioral change to modify the main lifestyle factors (physical activity, diet, alcohol and tobacco) in adults receiving primary health care (PHC). METHODS: We searched the MEDLINE and Cochrane Database of Systematic Reviews from January 2000 to December 2012. Two reviewers independently performed the first screening of titles and abstracts, the methodological quality assessment using the lecturacritica.com tool, and the extraction of necessary data to systematize the available information. RESULTS: Only few studies met the inclusion criteria (17 studies from 30 articles). Thirteen were randomized controlled trials, three systematic reviews, and one observational study. The transtheoretical model was the most frequent (13 studies), and obtained strong evidence of its effectiveness for dietary interventions in the short-term and for smoking cessation interventions in the long-term as compared to usual PHC practice. Limited evidence was found for smoking cessation interventions based in the social cognitive theory. CONCLUSION: There are few studies that explicitly link intervention strategies and theories of behavioral change. A rigorous evaluation of the theoretical principles could help researchers and practitioners to understand how and why interventions succeed or fail.

Efficacy of a cognitive and behavioural psychotherapy applied by primary care psychologists in patients with mixed anxiety-depressive disorder: a research protocol.

BACKGROUND: In contrast with the recommendations of clinical practice guidelines, the most common treatment for anxiety and depressive disorders in primary care is pharmacological. The aim of this study is to assess the efficacy of a cognitive-behavioural psychological intervention, delivered by primary care psychologists in patients with mixed anxiety-depressive disorder compared to usual care. METHODS/DESIGN: This is an open-label, multicentre, randomized, and controlled study with two parallel groups. A random sample of 246 patients will be recruited with mild-to-moderate mixed anxiety-depressive disorder, from the target population on the lists of 41 primary care doctors. Patients will be randomly assigned to the intervention group, who will receive standardised cognitive-behavioural therapy delivered by psychologists together with usual care, or to a control group, who will receive usual care alone. The cognitive-behavioural therapy intervention is composed of eight individual 60-minute face-to face sessions conducted in eight consecutive weeks. A follow-up session will be conducted over the telephone, for reinforcement or referral as appropriate, 6 months after the intervention, as required. The primary outcome variable will be the change in scores on the Short Form-36 General Health Survey. We will also measure the change in the frequency and intensity of anxiety symptoms (State-Trait Anxiety Inventory) and depression (Beck Depression Inventory) at baseline, and 3, 6 and 12 months later. Additionally, we will collect information on the use of drugs and health care services. DISCUSSION: The aim of this study is to assess the efficacy of a primary care-based cognitive-behavioural psychological intervention in patients with mixed anxiety-depressive disorder. The international scientific evidence has demonstrated the need for psychologists in primary care. However, given the differences between health policies and health services, it is important to test the effect of these psychological interventions in our geographical setting. TRIAL REGISTRATION: NCT01907035 (July 22, 2013).

Supervised exercise for acute coronary patients in primary care: a randomized clinical trial.

BACKGROUND: Functional capacity is a prognostic factor for coronary patients; accordingly, they are recommended to walk. OBJECTIVE: To assess whether an exercise program supervised in primary care increases their functional capacity more than unsupervised walking. METHODS: A randomized clinical trial was carried out at eight primary care centres of the Spanish Health Service and involving 97 incident cases of low-risk acute coronary patients, <80 years old, randomly assigned to either an unsupervised walking program (UW group; n = 51) or a 6-month cycle ergometer exercise program with gradually increasing frequency and workload intensity supervised by primary care nurses (SE group; n = 46). The two groups received the same common components of secondary prevention care. Changes in functional capacity were assessed in terms of peak oxygen consumption (VO2peak) during exercise testing measured at baseline and at 7 months by cardiologists blinded to group assignment. RESULTS: Overall, 76% of participants completed the study, 30 in the SE and 44 in the UW. Both groups increased baseline-adjusted VO2peak: 5.56ml/kg per minute in the SE (95% confidence interval [CI] 3.38-7.74) and 1.64ml/kg per minute in the UW (95% CI -0.15 to 3.45). The multivariate-adjusted difference between groups was 4.30ml/kg per minute (95% CI 1.82-6.79; P = 0.001) when analyzing completers and 2.83ml/kg per minute (95% CI 0.61-5.05; P = 0.01) in the intention-to-treat analysis, including all participants with baseline values carried forward for those lost to follow-up. CONCLUSIONS: A cycle ergometer exercise program supervised by primary care nurses increased the functional capacity of coronary patients more than unsupervised walking with a clinically relevant difference.

Predictors of long-term change of a physical activity promotion programme in primary care.

BACKGROUND: Further research is needed to improve the evidence regarding determinants of physical activity (PA) as a crucial step to plan higher effective intervention strategies. The goal of the present study is to identify socio-demographic and clinical characteristics of primary care (PHC) insufficiently active patients that are associated with longitudinal changes in the level of physical activity. METHODS: Longitudinal analysis of baseline socio-demographic and clinical predictors of physical activity change in insufficiently active PHC patients who participated in a PA-promoting multi-centre randomized clinical trial conducted from October 2003 through March 2006. The primary outcome measure was the self-reported physical activity assessed with the 7-day Physical Activity Recall (PAR), at baseline, 6, 12 and 24 months. Baseline covariates included sex, age, social class, anthropometric measures and other cardiovascular risk factors or associated diseases (Diabetes, HTA, tobacco use, etc.), and stage of readiness to change PA. Generalized linear mixed models were used to estimate longitudinal association of studied variables on PA change over the three follow-up measurements. RESULTS: A total of 3691 patients (85% of the 4317 recruited in the trial) with at least one follow-up measurement were included in the longitudinal analysis. At baseline, analysed patients (mean age: 50.6 years; 64.6% women) devoted 34.7 minutes and 2.36 metabolic equivalent hours per week (MET.h/week) to moderate and vigorous physical activity. Older age, male gender, higher social class, lower BMI, diagnosis of diabetes or hypertension, and measurement season were significant predictors of PA longitudinal change. The effect of baseline readiness to change on PA dose was modified by time, showing a positive gradient in favour of those with more readiness to change that increases significantly at 12 and 24 months (p-value interaction < .0001). CONCLUSIONS: Identified baseline characteristics such as readiness to change and risk factors can guide physicians to prioritize time and intervention efforts for maximizing their impact on insufficiently active PHC patients.

Efficacy and safety of autologous platelet rich plasma for the treatment of vascular ulcers in primary care: Phase III study.

BACKGROUND: Vascular ulcers are commonly seen in daily practice at all levels of care and have great impact at personal, professional and social levels with a high cost in terms of human and material resources. Given that the application of autologous platelet rich plasma has been shown to decrease healing times in various different studies in the hospital setting, we considered that it would be interesting to assess the efficacy and feasibility of this treatment in primary care. The objectives of this study are to assess the potential efficacy and safety of autologous platelet rich plasma for the treatment of venous ulcers compared to the conventional treatment (moist wound care) in primary care patients with chronic venous insufficiency (C, clinical class, E, aetiology, A, anatomy and P, pathophysiology classification C6). DESIGN: We will conduct a phase III, open-label, parallel-group, multicentre, randomized study. The subjects will be 150 patients aged between 40 and 100 years of age with an at least 2-month history of a vascular venous ulcer assigned to ten primary care centres. For the treatment with autologous platelet rich plasma, all the following tasks will be performed in the primary care setting: blood collection, centrifugation, separation of platelet rich plasma, activation of coagulation adding calcium chloride and application of the PRP topically after gelification. The control group will receive standard moist wound care. The outcome variables to be measured at baseline, and at weeks 5 and 9 later include: reduction in the ulcer area, Chronic Venous Insufficiency Quality of Life Questionnaire score, and percentage of patients who require wound care only once a week. DISCUSSION: The results of this study will be useful to improve the protocol for using platelet rich plasma in chronic vascular ulcers and to favour wider use of this treatment in primary care. TRIAL REGISTRATION: Current Controlled Trials NCT02213952.