De-imFAR phase II project: a study protocol for a cluster randomised implementation trial to evaluate the effectiveness of de-implementation strategies to reduce low-value statin prescribing in the primary prevention of cardiovascular disease.

INTRODUCTION: This study aims to reduce potentially inappropriate prescribing (PIP) of statins and foster healthy lifestyle promotion in cardiovascular disease (CVD) primary prevention in low-risk patients. To this end, we will compare the effectiveness and feasibility of several de-implementation strategies developed following the structured design process of the Behaviour Change Wheel targeting key determinants of the clinical decision-making process in CVD prevention. METHODS AND ANALYSIS: A cluster randomised implementation trial, with an additional control group, will be launched, involving family physicians (FPs) from 13 Integrated Healthcare Organisations (IHOs) of Osakidetza-Basque Health Service with non-zero incidence rates of PIP of statins in 2021. All FPs will be exposed to a non-reflective decision assistance strategy based on reminders and decision support tools. Additionally, FPs from two of the IHOs will be randomly assigned to one of two increasingly intensive de-implementation strategies: adding a decision information strategy based on knowledge dissemination and a reflective decision structure strategy through audit/feedback. The target population comprises women aged 45-74 years and men aged 40-74 years with moderately elevated cholesterol levels but no diagnosed CVD and low cardiovascular risk (REGICOR<7.5%), who attend at least one appointment with any of the participating FPs (May 2022-May 2023), and will be followed until May 2024. We use the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework to evaluate outcomes. The main outcome will be the change in the incidence rate of PIP of statins and healthy lifestyle counselling in the study population 12 and 24 months after FPs' exposure to the strategies. Moreover, FPs' perception of their feasibility and acceptability, and patient experience regarding the quality of care received will be evaluated. ETHICS AND DISSEMINATION: The study was approved by the Basque Country Clinical Research Ethics Committee and was registered in ClinicalTrials.gov (NCT04022850). Results will be disseminated in scientific peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04022850.

Differences in Functional Capacity between Oncologic and Non-Oncologic Populations: Reference Values.

This study is focused on the fact that in the context of increasing global aging and cancer diagnoses, additional challenges arise in clinical care. Adequate functionality and body composition are key to coping with antineoplastic treatment, which can lead to better treatment tolerance, survival, and quality of life. This is a cross-sectional comparative study focused on the assessment and comparison of body composition and functionality between cancer patients and a reference population, with the aim of establishing meaningful baseline values. Techniques such as manual dynamometry, the Five-Times Sit-to-Stand test, and bioimpedance were used to collect data from 374 oncologic patients and 1244 reference individuals. The results reveal significant disparities in functionality and body composition among participants, and provide age group-specific adjusted baseline values for those diagnosed with cancer. These findings may have crucial clinical implications for applying particular cut-off points designed for this population group, which makes the assessment process faster and more accurate, enhances the capacity of medical personnel to act quickly, and improves the management of frailty in cancer patients.

Validity and reliability of the transculturally adapted Spanish version of the Implementation Leadership Scale (ILS).

BACKGROUND: There is a need for pragmatic and reliable measures of sound factors that affect evidence-based practice (EBP) adoption and implementation in different languages and cultural environments. The Implementation Leadership Scale (ILS) is a brief and efficient measurement tool of strategic leadership for EBP implementation. The objective of this study was to assess the psychometric properties of the Spanish version of the ILS. METHODS: The process of translation of the original ILS into Spanish consisted of forward translation, panel meeting, and back-translation. Scale face and content validity compared to that of the original version were assessed and ensured before agreement on the final version. Psychometric properties were examined in 144 healthcare professionals (family physicians, pediatricians, practice and pediatric nurses) involved in implementation or improvement research projects. ILS factor structure was tested by confirmatory factor analysis (CFA). Reliability was assessed by internal consistency analysis. The Pearson correlation between the ILS and the Organizational Support dimension of the Organizational Readiness for Knowledge Translation (OR4KT) questionnaire in the subsample of pediatricians and pediatric nurses (n = 52) was estimated for convergent validity analysis. RESULTS: The CFA results indicated that the original four theorized first-order factors with a second-order Implementation Leadership factor fit the data well (χ2 = 107.70; df = 45; p < 0.001). All standardized first- and second-order factor loadings were statistically significant. Fit indexes showed acceptable figures (GFI = 0.90; CFI = 0.97; RMSEA = 0.10; SRMR = 0.053). Cronbach's alpha coefficient for the four dimensions of ILS ranged from 0.90 to 0.97, while the reliability estimated for the total scale was 0.95. Results of convergent validity revealed high correlation (r = 0.56) between the ILS and the OR4KT's Organizational Support dimension. CONCLUSION: The CFA results demonstrated that the tested first- and second-order factor structure of the 12-item Spanish version of the ILS is consistent with the factor structure of the original tool. The availability of the ILS will allow Spanish-speaking researchers to assess and advance understanding of the implementation leadership construct as a predictor of organizational implementation context.

Association between Phase Angle and Subjective Perceptions of Health Variables in Cancer Patients.

The phase angle, an increasingly studied healthcare tool, was studied to explore its relationship with psychological factors in cancer patients. The aim of this study was to investigate the relationship between the phase angle (PhA), obtained by the bioimpedance analysis of body composition, and psychological factors measured by questionnaire in cancer patients. The study included 311 patients who underwent bioimpedance testing to determine their PhA value; their psychological profiles were assessed using SF-36, FACIT, QLQ-C30, and GHQ-12 questionnaires. Mixed linear regression models were used to analyze the relationship between PhA and the psychological tests. The results showed a statistical correlation between PhA and the GHQ-12, FACIT, and SF-36 questionnaires, with higher PhA values associated with better results on the questionnaires. In the QLQ-C30 questionnaire, a correlation was observed between PhA and the functioning scales (p < 0.001), except for emotional and cognitive functioning (p = 0.148 and p = 0.544, respectively), but not in most of the symptom scales. The PhA is a useful tool for assessing the subjective health perception of cancer patients, especially with regard to psychological factors. While there is a statistically significant correlation, further research is required before confidently applying it in clinical practice. The current predictive value of this predictor for certain psychological aspects is limited, underscoring the need for additional research.

Nurse-Supervised Exercise for People with Stage IV Cancer: The EFICANCER Randomized Clinical Trial.

OBJECTIVES: To assess the effectiveness of the EFICANCER individualized and supervised exercise program for people with gastrointestinal, breast, or non-small cell lung stage IV cancer, in terms of quality of life and functional capacity. DATA SOURCES: Randomized controlled clinical trial with two parallel groups: EFICANCER (n = 47) and control (n = 43). Both groups received standard oncological care. In addition, the EFICANCER group participated in a nurse-supervised exercise program. Primary outcome was cancer-specific (EORTC QLQ-C30 questionnaire) and general quality of life (SF-36) at baseline and after 2, 6, and 12 months. Secondary outcomes were functional capacity (6-minute walking test), strength, and fatigue. The evolution in both groups was compared over 12 months using mixed-effect longitudinal models; 74.47% of patients completed at least one session of the program. At 12 months, EFICANCER group had better scores in cancer-related quality of life, with a difference between groups of 15.7 points (95% confidence interval 4.4 to 25.9) and in functional capacity, with a difference of 4.5 points (95% confidence interval -0.5 to 9.5). No significant differences in any other secondary variables were observed. CONCLUSION: The EFICANCER primary care nurse supervised exercise program is safe and feasible and improves cancer patient's outcomes. IMPLICATIONS FOR NURSING PRACTICE: Providing the best care and trying to improve the quality of life of cancer patients are essential parts of nursing practice. Eficancer adds a new dimension to nursing practice by providing greater attention and care to patients during treatment through the supervision of physical exercise, thereby contributing to improve the quality of life of this population.

Changes in Cardiorespiratory Fitness and Probability of Developing Abdominal Obesity at One and Two Years.

Low cardiorespiratory fitness (CRF) is associated with an increased risk of developing abdominal obesity (AO), but it is not known if and/or how changes in CRF affect AO. We examined the relationship between changes in CRF and the risk of developing AO. This is a retrospective observational study of a cohort of 1883 sedentary patients, who had participated in a clinical trial of physical activity promotion carried out in Spain (2003-2007). These data were not used in the clinical trial. At baseline, they were free of cardiovascular disease, hypertension, diabetes, dyslipidemia, and/or AO; with an indirect VO2max measurement; 19-80 years old; and 62% were women. All the measures were repeated at 6, 12, and 24 months. The exposure factor was the change in CRF at 6 or 12 months, categorized in these groups: unfit-unfit, unfit-fit, fit-unfit, and fit-fit. We considered fit and unfit participants as those with VO2max values in the high tertile, and in the moderate or low tertiles, respectively. The main outcome measure was the risk of developing AO at one and two years, as defined by waist circumference >102 (men) and >88 (women) cm. At two years, 10.5% of the participants had developed AO: 13.5% in the unfit-unfit group of change at 6 months; 10.3% in the unfit-fit group (adjusted odds ratio (AOR) 0.86; 95% confidence interval (CI) 0.49-1.52); 2.6% in the fit-unfit group (AOR 0.13; 95%CI 0.03-0.61); and 6.0% in the fit-fit group (AOR 0.47; 95%CI 0.26-0.84). Those who stayed fit at 6 months decreased the probability of developing abdominal obesity at two years.

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

Objetivo: Averiguar en qué medida es posible dejar de tener obesidad (normalizar el índice de masa corporal [IMC], el perímetro abdominal [PA] y/o el porcentaje de grasa corporal [PGC]). Diseño: Estudio de observación longitudinal y retrospectiva. Emplazamiento: Once centros de salud españoles. Participantes: Hombres y mujeres con IMC≥30kg/m2 (n=1.246) u obesidad general (OG), con PA>102cm y >88cm, respectivamente (n=2.122) u obesidad abdominal (OA) y con PGC>25% y >35%, respectivamente (n=2.436) o exceso de grasa corporal (EGC), de la cohorte del Estudio PEPAF de 4.927 participantes de 20 a 80años de edad. Mediciones principales: Datos procedentes del Estudio PEPAF de la captación y de 6, 12 y 24meses: sexo, edad, diagnósticos de diabetes, hipertensión arterial y dislipemia, hábito tabáquico, niveles y cumplimiento de las recomendaciones de actividad física, consumo máximo de oxígeno, peso, talla, PA y tres pliegues grasos cutáneos (torácico, umbilical y muslo anterior para hombres y tríceps, suprailíaco y muslo anterior para mujeres). Resultados: De 2.054 participantes con cualquier tipo de obesidad en la captación y datos válidos a los 2años, 240 (11,6%) habían normalizado todos sus índices diagnósticos de obesidad en ese tiempo. El 19,5% (intervalo de confianza al 95% (IC95%): 17,6-21,4) habían dejado de tener EGC, el 12,0% (IC95%: 10,4-13,7) habían dejado de tener OA y el 10,5% (IC95%: 8,5-12,7) habían dejado de tener OG. Conclusiones: La obesidad se diferencia de las demás enfermedades crónicas en que es posible «curarse» de ella normalizando la cantidad de grasa corporal.(AU)

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 «cured» by normalizing the amount of body fat.(AU)

Association between PhA and Physical Performance Variables in Cancer Patients.

Maintaining the physical performance of cancer patients is increasingly considered due to the growing number of cancer patients and the aggressiveness of the treatments. For this reason, bioimpedance is now being used to record patients' body composition by obtaining the phase angle (PhA). Although there is a direct relationship between PhA, age, sex and disease prognosis, it has not been measured as an analysis of physical performance in oncology patients and is a valid tool in the follow-up of cancer patients. For this purpose, 311 patients were evaluated, and both bioelectrical impedance analysis (BIA) and physical performance measurements were performed. The modification of the results concerning PhA was found to be highly relational, as a variation in one of the variables affected the other. It was concluded that each degree increase in PhA modified -22.57 s [-27.58; -17.53] in 400-m walking test (400 mWT); 13.25 kg [10.13; 16.35] in upper-body strength (UBS); 6.3 [4.95; 7.65] in lower-body strength (LBS); 1.55 mL/kg/min [0.98; 2.12] in VO2peak; 6.53 Watts [3.83; 9.20] in ventilatory threshold 1 (VT1); 10.36 Watts [7.02; 13.64] in ventilatory threshold 2 (VT2). It was also noted that age was a factor that affected the relationship between PhA and 400 mWT; the older the age, the higher the relationship. PhA data has been shown to be highly correlated with physical performance. This is of great importance in clinical practice because a cancer patient's physical performance levels can be assessed during treatment.

Any increment in physical activity reduces mortality risk of physically inactive patients: prospective cohort study in primary care.

BACKGROUND: It is unclear how engaging in physical activity after long periods of inactivity provides expected health benefits. AIM: To determine whether physically inactive primary care patients reduce their mortality risk by increasing physical activity, even in low doses. DESIGN AND SETTING: Prospective cohort of 3357 physically inactive patients attending 11 Spanish public primary healthcare centres. METHOD: Change in physical activity was repeatedly measured during patients' participation in the 'Experimental Program for Physical Activity Promotion' clinical trial between 2003 and 2006, using the '7-day Physical Activity Recall'. Mortality to 31 December 2018 (312 deaths) was recorded from national statistics, and survival time from the end of the clinical trial analysed using proportional hazard models. RESULTS: After 46 191 person-years of follow-up, compared with individuals who remained physically inactive, the mortality rates of those who achieved the minimum recommendations of 150-300 min/week of moderate- or 75-150 min/week of vigorous-intensity exercise was reduced by 45% (adjusted hazard ratio [aHR] 0.55; 95% confidence interval [95% CI] = 0.41 to 0.74); those who did not meet these recommendations but increased physical activity in low doses, that is, 50 min/week of moderate physical activity, showed a 31% reduced mortality (aHR 0.69, 95% CI = 0.51 to 0.93); and, those who surpassed the recommendation saw a 49% reduction in mortality (aHR 0.51, 95% CI = 0.32 to 0.81). The inverse association between increased physical activity and mortality follows a continuous curvilinear dose-response relationship. CONCLUSION: Physically inactive primary care patients reduced their risk of mortality by increasing physical activity, even in doses below recommended levels. Greater reduction was achieved through meeting physical activity recommendations or adopting levels of physical activity higher than those recommended.

Physiological and mental health changes in cancer patients during the COVID-19 state of emergency.

Backgrounds: Due to the COVID-19 pandemic that we are currently facing, many governments across the world have declared a state of emergency and even confinements. This stressful situation, in addition to prolonged stays at home, may imply a radical change in lifestyle behavior and physical activity (PA). The aim of this study is to evaluate the physiological and psychological effects in cancer patients who changed their PA habits during the COVID-19 state of emergency in Spain. Methods: Thirty-three participants were evaluated pre- and post-state of emergency. A series of questionnaires was used to assess cancer-specific quality of life. Results: The most relevant results revealed significantly lower walking time (p < 0.001) and sitting time (p = 0.014). Upper and lower body strength also decreased significantly (p = 0.009 and 0.012, respectively) and oxygen consumption (VO2 peak) (p = 0.023). None of the parameters analysed showed significant differences for psychological aspects (QLQ-C-30 and SF-36) and body composition. Conclusion: Lower physical activity leads to negative physiological adaptation, particularly affecting cardiovascular and strength levels. While it is important to maintain the general population's amount and intensity of exercise, this particularly vulnerable group's physical capacity is vital to their health and well-being.

[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.

Applying the behavior change wheel to design de-implementation strategies to reduce low-value statin prescription in primary prevention of cardiovascular disease in primary care.

Introduction: A substantial proportion of individuals with low cardiovascular risk receive inappropriate statin prescription for primary prevention of cardiovascular disease (CVD) instead of the evidence-based recommendations to promote healthy lifestyle behaviors. This study reports on the structured process performed to design targeted de-implementation strategies to reduce inappropriate prescription of statins and to increase healthy lifestyle promotion in low cardiovascular risk patients in Primary Care (PC). Methods: A formative study was conducted based on the Theoretical Domains Framework and the Behavior Change Wheel (BCW). It comprised semi-structured interviews with PC professionals to define the problem in behavioral terms; focus groups with Family Physicians and patients to identify the determinants (barriers and facilitators) of inappropriate statin prescription and of healthy lifestyle promotion practice; mapping of behavioral change interventions operationalized as de-implementation strategies for addressing identified determinants; and consensus techniques for prioritization of strategies based on perceived effectiveness, feasibility and acceptability. Results: Identified key determinants of statin prescription and healthy lifestyle promotion were: the lack of time and clinical inertia, external resources, patients' preferences and characteristics, limitation of available clinical tools and guidelines, social pressures, fears about negative consequences of not treating, and lack of skills and training of professionals. Fourteen potential de-implementation strategies were mapped to the identified determinants and the following were prioritized: 1) non-reflective decision assistance strategies based on reminders and decision support tools for helping clinical decision-making; 2) decision information strategies based on the principles of knowledge dissemination (e.g., corporative diffusion of evidence-based Clinical Practice Guidelines and Pathways for CVD primary prevention); 3) reflective decision-making restructuring strategies (i.e., audit and feedback provided along with intention formation interventions). Conclusions: This study supports the usefulness of the BCW to guide the design and development of de-implementation strategies targeting the determinants of clinicians' decision-making processes to favor the abandonment of low-value practices and the uptake of those recommended for CVD primary prevention in low-risk patients. Further research to evaluate the feasibility and effectiveness of selected strategies is warranted. Clinical trial registration: Sanchez A. De-implementation of Low-value Pharmacological Prescriptions (De-imFAR). ClinicalTrials.gov, Identifier: NCT04022850. Registered July 17, 2019. In: ClinicalTrials.gov. Bethesda (MD): U.S. National Library of Medicine (NLM). Available from: https://www.clinicaltrials.gov/ct2/show/NCT04022850.

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

Objetivo: Explorar las percepciones de los pacientes durante el programa de ejercicio y detectar las barreras y los facilitadores que influyen en la adherencia al ejercicio al término de la supervisión. Diseño: Estudio observacional cualitativo con grupos de discusión como principal técnica de recogida de datos. Lugar: Centros de atención primaria de Vizcaya. Participantes: De los 175 pacientes aleatorizados del ensayo híbrido de efectividad-implementación se incluyeron 19 pacientes del grupo intervención (12 pacientes oncohematológicos en estadios avanzados y 7 con trastorno mental grave). Métodos: Se ha realizado un análisis de contenido de las transcripciones generadas, combinando un enfoque deductivo, basado en los dominios del marco teórico PRACTIS y uno inductivo, basado en los postulados de la teoría fundamentada. Resultados: Los participantes se mostraron satisfechos con el programa EfiKroniK y los beneficios fueron: descubrimiento de los beneficios del ejercicio físico, la gestión psicológica y emocional de la enfermedad, los beneficios de la comunicación entre iguales y del apoyo emocional y romper con la rutina de la enfermedad. Los participantes disminuyeron los niveles de ejercicio físico al término de la supervisión por la confluencia de diferentes barreras. Conclusión:Un programa de ejercicio supervisado realizado en atención primaria contribuyó a mejorar la calidad de vida, el bienestar emocional y social de pacientes en estadios avanzados de su enfermedad. Nuestro estudio ha identificado barreras potenciales y facilitadores asociados con la participación en el ejercicio y su continuidad; sin embargo, es necesario promover la coordinación intersectorial en el espacio sociosanitario para fomentar una atención integrada y continuada a los pacientes crónicos.(AU)

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.(AU)

[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.

"My Patients Asked Me If I Owned a Fruit Stand in Town or Something." Barriers and Facilitators of Personalized Dietary Advice Implemented in a Primary Care Setting.

Primary care is especially well positioned to address prevention of non-communicable diseases. However, implementation of health promotion activities such as personalized dietary advice is challenging. The study aim was to understand barriers and facilitators of the personalized dietary advice component of a lifestyle intervention in primary care, as perceived by health center professionals and program participants. Thirteen focus groups were conducted with 49 professionals and 47 participants. Audio recordings were transcribed. Professional group text was coded using the Consolidated Framework for Implementation Research (CFIR). Participant group text was coded via an inductive approach with thematic analysis. Across most CFIR domains, both barriers and facilitators were equally present, except for 'characteristics of individuals', which were primarily facilitators. Intervention characteristics was the most important domain, with barriers in design and packaging (e.g., the ICT tool) and complexity. Facilitators included high evidence strength and quality, adaptability, and relative advantage. Participants described the importance of more personalized advice, the value of follow-up with feedback, and the need to see outcomes. Both professionals and patients stated that primary care was the place for personalized dietary advice intervention, but that lack of time, workload, and training were barriers to effective implementation. Implementation strategies targeting these modifiable barriers could potentially increase intervention adoption and intervention effectiveness.

Barriers and facilitators in the implementation of an evidence-based health promotion intervention in a primary care setting: a qualitative study.

PURPOSE: This study aims to elucidate the health care organization, management and policy barriers and facilitators associated with implementation of an evidence-based health promotion intervention in primary care centers in the Basque Country, Spain. DESIGN/METHODOLOGY/APPROACH: Seven focus groups were conducted with 49 health professionals from six primary care centers participating in the Prescribing Healthy Life program. Text was analyzed using the Consolidated Framework for Implementation Research (CFIR) focusing on those constructs related to health care organization, management and policy. FINDINGS: The health promotion intervention was found to be compatible with the values of primary care professionals. However, professionals at all centers reported barriers to implementation related to: (1) external policy and incentives, (2) compatibility with existing workflow and (3) available resources to carry out the program. Specific barriers in these areas related to lack of financial and political support, consultation time constraints and difficulty managing competing day-to-day demands. Other barriers and facilitators were related to the constructs networks and communication, culture, relative priority and leadership engagement. A set of six specific barrier-facilitator pairs emerged. ORIGINALITY/VALUE: Implementation science and, specifically, the CFIR constructs were used as a guide. Barriers and facilitators related to the implementation of a health promotion program in primary care were identified. Healthcare managers and policy makers can modify these factors to foster a more propitious implementation environment. These factors should be appropriately monitored, both in pre-implementation phases and during the implementation process, in order to ensure effective integration of health promotion into the primary care setting.

Implementing Exercise in Standard Cancer Care (Bizi Orain Hybrid Exercise Program): Protocol for a Randomized Controlled Trial.

BACKGROUND: Despite the established benefits of regular exercise for patients with cancer to counteract the deleterious effects of the disease itself and treatment-related adverse effects, most of them do not engage in sufficient levels of physical activity and there is a paucity of data on the integration of efficacious exercise programs that are accessible and generalizable to a large proportion of patients with cancer into routine cancer care. OBJECTIVE: We intend to examine the effects attributable to the implementation of a community-based exercise program on cardiorespiratory functional capacity and quality of life for patients with cancer. METHODS: This will be a hybrid study. In the first experimental phase, patients diagnosed with any type of cancer will be randomized into two parallel groups. One group immediately performs Bizi Orain, a 3-month supervised exercise program (3 times a week), in addition to behavioral counseling in a primary health care setting; the other is a reference group that starts the exercise program 3 months later (delayed treatment). In the second observational phase, the entire cohort of participants will be followed-up for 5 years. Any person diagnosed with cancer in the previous 2 years is eligible for the program. The program evaluation involves the uptake, safety, adherence, and effectiveness assessed after completion of the program and with follow-ups at 3, 6, 12, 24, 36, 48, and 60 months. The primary outcomes of the experimental study, to be compared between groups, are improved physical function and quality of life, whereas overall survival is the main objective of the prospective study. To analyze the association between changes in physical activity levels and overall survival, longitudinal mixed-effects models will be used for repeated follow-up measures. RESULTS: A total of 265 patients have been enrolled into the study since January 2019, with 42 patients from the hematology service and 223 from the oncology service. CONCLUSIONS: Bizi Orain is the first population-based exercise program in Spain that will offer more insight into the implementation of feasible, generalizable, and sustainable supportive care services involving structured exercise to extend survival of patients with cancer, improve their physical function and quality of life, and reverse the adverse effects of their disease and related treatments, thereby reducing the clinical burden. TRIAL REGISTRATION: ClinicalTrials.gov NCT03819595; http://clinicaltrials.gov/ct2/show/NCT03819595. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/24835.

Effectiveness of two procedures for deploying a facilitated collaborative modeling implementation strategy-the PVS-PREDIAPS strategy-to optimize type 2 diabetes prevention in primary care: the PREDIAPS cluster randomized hybrid type II implementation trial.

BACKGROUND: The most efficient procedures to engage and guide healthcare professionals in collaborative processes that seek to optimize practice are unknown. The PREDIAPS project aims to assess the effectiveness and feasibility of different procedures to perform a facilitated interprofessional collaborative process to optimize type 2 diabetes prevention in routine primary care. METHODS: A type II hybrid cluster randomized implementation trial was conducted in nine primary care centers of the Basque Health Service. All centers received training on effective healthy lifestyle promotion. Headed by a local leader and an external facilitator, centers conducted a collaborative structured process-the PVS-PREDIAPS implementation strategy-to adapt the intervention and its implementation to their specific context. The centers were randomly allocated to one of two groups: one group applied the implementation strategy globally, promoting the cooperation of all health professionals from the beginning, and the other performed it sequentially, centered first on nurses, who later sought the pragmatic cooperation of physicians. The following patients were eligible for inclusion: all those aged ≥ 30 years old with at least one known cardiovascular risk factor and an impaired fasting glucose level (≥ 110-125 mg/dl) but without diabetes who attended centers during the study period. The main outcome measures concerned changes in type 2 diabetes prevention practice indicators after 12 months. RESULTS: After 12 months, 3273 eligible patients at risk of type 2 diabetes had attended their family physician at least once, and of these, 490 (15%) have been addressed by assessing their healthy lifestyles in both comparison groups. The proportion of at-risk patients receiving a personalized prescription of lifestyle change was slightly higher (8.6%; range 13.5-5.9% vs 6.8%; range 7.2-5.8%) and 2.3 times more likely (95% CI for adjusted hazard ratio, 1.38-3.94) in the sequential than in the global centers, after 8 months of the intervention program implementation period. The probability of meeting the recommended levels of physical activity and fruit and vegetable intake were four- and threefold higher after the prescription of lifestyle change than only assessment and provision of advice. The procedure of engagement in and execution of the implementation strategy does not modify the effect of prescribing healthy habits (p interaction component of intervention by group, p > 0.05). DISCUSSION: Our results show that the PVS-PREDIAPS implementation strategy manages to integrate interventions with proven efficacy in the prevention of type 2 diabetes in clinical practice in primary care. Further, they suggest that implementation outcomes were somewhat better with a sequential facilitated collaborative process focused on enhancing the autonomy and responsibility of nurses who subsequently seek a pragmatic cooperation of GPs. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT03254979 . Registered 16 August 2017-retrospectively registered.

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.

Reproducibility study of nocturnal blood pressure dipping in patients with high cardiovascular risk.

It has been shown that in most people there is a physiological reduction in blood pressure during nighttime sleep, it falling by approximately 10% compared to daytime values (dippers). On the other hand, in some people, there is no nighttime reduction (non-dippers). Various studies have found an association between being a non-dipper and a higher risk of cardiovascular disease, but few have assessed whether the nocturnal pattern is maintained over time. From the database of the TAHPS study, data were available on 225 patients, each of whom underwent 24-hour ambulatory blood pressure monitoring (ABPM) on four occasions over a period of 5 months. We studied the reproducibility of the nocturnal BP dipping pattern with mixed linear analysis and also calculated the concordance in the classification of patients as dippers or non-dippers. The intraclass correlation coefficients between the different ABPM recordings were 0.482 and 0.467 for systolic and diastolic blood pressure, respectively. Two-thirds (67%) and 70% of the patients classified, respectively, as dippers or non-dippers based on systolic and diastolic blood pressure readings in the first ABPM recording were found to have the same classification based on the subsequent recordings. We conclude that the reproducibility of nocturnal dipping patterns and concordance of dipper vs non-dipper status in individual patients is modest and therefore that we should be cautious about recommending treatments or interventions based on these patterns.