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BACKGROUND: A new intervention aimed at managing patients with medically unexplained symptoms (MUS) based on a specific set of communication techniques was developed, and tested in a cluster randomised clinical trial. Due to the modest results obtained and in order to improve our intervention we need to know the GPs' attitudes towards patients with MUS, their experience, expectations and the utility of the communication techniques we proposed and the feasibility of implementing them. Physicians who took part in 2 different training programs and in a randomised controlled trial (RCT) for patients with MUS were questioned to ascertain the reasons for the doctors' participation in the trial and the attitudes, experiences and expectations of GPs about the intervention. METHODS: A qualitative study based on four focus groups with GPs who took part in a RCT. A content analysis was carried out. RESULTS: Following the RCT patients are perceived as true suffering persons, and the relationship with them has improved in GPs of both groups. GPs mostly valued the fact that it is highly structured, that it made possible a more comfortable relationship and that it could be applied to a broad spectrum of patients with psychosocial problems. Nevertheless, all participants consider that change in patients is necessary; GPs in the intervention group remarked that that is extremely difficult to achieve. CONCLUSION: GPs positively evaluate the communication techniques and the interventions that help in understanding patient suffering, and express the enormous difficulties in handling change in patients. These findings provide information on the direction in which efforts for improving intervention should be directed. TRIAL REGISTRATION: US ClinicalTrials.gov NCT00130988. [ABSTRACT FROM AUTHOR]

Background. Somatizing patients are a challenge to general practitioners (GPs). A cluster randomized controlled trial was conducted to asses the effect of specific communication techniques delivered by GPs on somatizing patients' self-perceived health.Method. Thirty-nine GPs were assigned randomly to two parallel groups. GPs in the intervention group treated somatic patients according to specific communication techniques focused on offering a physical explanation - release of hormones - and approaching sensitive topics in the patient's experience indirectly. Control GPs used the standard Goldberg reattribution technique. A total of 156 patients, aged 18-65 years, were selected randomly from a list of 468 patients with six or more active symptoms for women and four or more for men. All patients had six programmed 30-min consultations. Health-related quality of life (assessed with the 36-item Short-Form Health Survey, SF-36) and a summary utility index were used as outcome measures. Patients were interviewed at home at baseline and at 3, 8 and 12 months after the beginning of the intervention.Results. Patients in both groups improved in all dimensions of the SF-36. The time course of the quality of life was significantly better for the intervention group in five of the eight scales of the SF-36 (bodily pain, mental health, physical functioning, vitality, and social functioning) and in the utility index (p<0.039).Conclusions. Communication techniques were found to have a clinically relevant impact on body pain. This finding, together with a trend towards better scores in the remaining scales, justifies the use of these techniques in psychosocial interventions delivered to patients with medically unexplained symptoms. [ABSTRACT FROM AUTHOR]

Abstract Background The objective of this study is to perform an independent evaluation of the feasibility and effectiveness of an educational programme for the primary prevention of type 2 diabetes (DM2) in high risk populations in primary care settings, implanted within the Basque Health Service - Osakidetza. Methods/design This is a prospective phase IV cluster clinical trial conducted under routine conditions in 14 primary health care centres of Osakidetza, randomly assigned to an intervention or control group. We will recruit a total sample of 1089 individuals, aged between 45 and 70 years old, without diabetes but at high risk of developing the condition (Finnish Diabetes Risk Score, FINDRISC ≥ 14) and follow them up for 2 years. Primary health care nursing teams of the intervention centres will implement DE-PLAN, a structured educational intervention program focused on changing healthy lifestyles (diet and physical activity); while the patients in the control centres will receive the usual care for the prevention and treatment of DM2 currently provided in Osakidetza. The effectiveness attributable to the programme will be assessed by comparing the changes observed in patients exposed to the intervention and those in the control group, with respect to the risk of developing DM2 and lifestyle habits. In terms of feasibility, we will assess indicators of population coverage and programme implementation. Discussion The aim of this study is to provide the scientific basis for disseminate the programme to the remaining primary health centres in Osakidetza, as a novel way of addressing prevention of DM2. The study design will enable us to gather information on the effectiveness of the intervention as well as the feasibility of implementing it in routine practice. Trial registration ClinicalTrials.gov NCT01365013

Abstract Background Chronic diseases are an increasing threat to people’s health and to the sustainability of health organisations. Despite the need for routine monitoring systems to assess the impact of chronicity in the population and its evolution over time, currently no single source of information has been identified as suitable for this purpose. Our objective was to describe the prevalence of various chronic conditions estimated using routine data recorded by health professionals: diagnoses on hospital discharge abstracts, and primary care prescriptions and diagnoses. Methods The ICD-9-CM codes for diagnoses and Anatomical Therapeutic Chemical (ATC) codes for prescriptions were collected for all patients in the Basque Country over 14 years of age (n=1,964,337) for a 12-month period. We employed a range of different inputs: hospital diagnoses, primary care diagnoses, primary care prescriptions and combinations thereof. Data were collapsed into the morbidity groups specified by the Johns Hopkins Adjusted Clinical Groups (ACGs) Case-Mix System. We estimated the prevalence of 12 chronic conditions, comparing the results obtained using the different data sources with each other and also with those of the Basque Health Interview Survey (ESCAV). Using the different combinations of inputs, Standardized Morbidity Ratios (SMRs) for the considered diseases were calculated for the list of patients of each general practitioner. The variances of the SMRs were used as a measure of the dispersion of the data and were compared using the Brown-Forsythe test. Results The prevalences calculated using prescription data were higher than those obtained from diagnoses and those from the ESCAV, with two exceptions: malignant neoplasm and migraine. The variances of the SMRs obtained from the combination of all the data sources (hospital diagnoses, and primary care prescriptions and diagnoses) were significantly lower than those using only diagnoses. Conclusions The estimated prevalence of chronic diseases varies considerably depending of the source(s) of information used. Given that administrative databases compile data registered for other purposes, the estimations obtained must be considered with caution. In a context of increasingly widespread computerisation of patient medical records, the complementary use of a range of sources may be a feasible option for the routine monitoring of the prevalence of chronic diseases.

Abstract Background Quality of life (QoL) decreases as heart failure worsens, which is one of the greatest worries of these patients. Physical exercise has been shown to be safe for people with heart failure. Previous studies have tested heterogeneous exercise programs using different QoL instruments and reported inconsistent effects on QoL. The aim of this study is to evaluate the effectiveness of a new exercise program for people with heart failure (EFICAR), additional to the recommended optimal treatment in primary care, to improve QoL, functional capacity and control of cardiovascular risk factors. Methods/Design Multicenter clinical trial in which 600 patients with heart failure in NYHA class II-IV will be randomized to two parallel groups: EFICAR and control. After being recruited, through the reference cardiology services, in six health centres from the Spanish Primary Care Prevention and Health Promotion Research Network (redIAPP), patients are followed for 1 year after the beginning of the intervention. Both groups receive the optimized treatment according to the European Society of Cardiology guidelines. In addition, the EFICAR group performs a 3 month supervised progressive exercise program with an aerobic (high-intensity intervals) and a strength component; and the programme continues linked with community resources for 9 months. The main outcome measure is the change in health-related QoL measured by the SF-36 and the Minnesota Living with Heart Failure Questionnaires at baseline, 3, 6 and 12 months. Secondary outcomes considered are changes in functional capacity measured by the 6-Minute Walking Test, cardiac structure (B-type natriuretic peptides), muscle strength and body composition. Both groups will be compared on an intention to treat basis, using multi-level longitudinal mixed models. Sex, age, social class, co-morbidity and cardiovascular risk factors will be considered as potential confounding and predictor variables. Discussion A key challenges of this study is to guarantee the safety of the patients; however, the current scientific evidence supports the notion of there being no increase in the risk of decompensation, cardiac events, hospitalizations and deaths associated with exercise, but rather the opposite. Safety assurance will be based on an optimized standardised pharmacological therapy and health education for all the participants. Trial Registration Clinical Trials.gov Identifier: NCT01033591

Abstract Background A new intervention aimed at managing patients with medically unexplained symptoms (MUS) based on a specific set of communication techniques was developed, and tested in a cluster randomised clinical trial. Due to the modest results obtained and in order to improve our intervention we need to know the GPs' attitudes towards patients with MUS, their experience, expectations and the utility of the communication techniques we proposed and the feasibility of implementing them. Physicians who took part in 2 different training programs and in a randomised controlled trial (RCT) for patients with MUS were questioned to ascertain the reasons for the doctors' participation in the trial and the attitudes, experiences and expectations of GPs about the intervention. Methods A qualitative study based on four focus groups with GPs who took part in a RCT. A content analysis was carried out. Results Following the RCT patients are perceived as true suffering persons, and the relationship with them has improved in GPs of both groups. GPs mostly valued the fact that it is highly structured, that it made possible a more comfortable relationship and that it could be applied to a broad spectrum of patients with psychosocial problems. Nevertheless, all participants consider that change in patients is necessary; GPs in the intervention group remarked that that is extremely difficult to achieve. Conclusion GPs positively evaluate the communication techniques and the interventions that help in understanding patient suffering, and express the enormous difficulties in handling change in patients. These findings provide information on the direction in which efforts for improving intervention should be directed. Trial registration US ClinicalTrials.gov NCT00130988

Abstract Background The adoption of a healthy lifestyle, including physical activity, a balanced diet, a moderate alcohol consumption and abstinence from smoking, are associated with large decreases in the incidence and mortality rates for the most common chronic diseases. That is why primary health care (PHC) services are trying, so far with less success than desirable, to promote healthy lifestyles among patients. The objective of this study is to design and model, under a participative collaboration framework between clinicians and researchers, interventions that are feasible and sustainable for the promotion of healthy lifestyles in PHC. Methods and design Phase I formative research and a quasi-experimental evaluation of the modelling and planning process will be undertaken in eight primary care centres (PCCs) of the Basque Health Service – OSAKIDETZA, of which four centres will be assigned for convenience to the Intervention Group (the others being Controls). Twelve structured study, discussion and consensus sessions supported by reviews of the literature and relevant documents, will be undertaken throughout 12 months. The first four sessions, including a descriptive strategic needs assessment, will lead to the prioritisation of a health promotion aim in each centre. In the remaining eight sessions, collaborative design of intervention strategies, on the basis of a planning process and pilot trials, will be carried out. The impact of the formative process on the practice of healthy lifestyle promotion, attitude towards health promotion and other factors associated with the optimisation of preventive clinical practice will be assessed, through pre- and post-programme evaluations and comparisons of the indicators measured in professionals from the centres assigned to the Intervention or Control Groups. Discussion There are four necessary factors for the outcome to be successful and result in important changes: (1) the commitment of professional and community partners who are involved; (2) their competence for change; (3) the active cooperation and participation of the interdisciplinary partners involved throughout the process of change; and (4) the availability of resources necessary to facilitate the change.

Abstract Background The adoption of a healthy lifestyle, including physical activity, a healthy diet, moderate alcohol consumption and abstinence from smoking, is associated with a major decrease in the incidence of chronic diseases and mortality. Primary health-care (PHC) services therefore attempt, with rather limited success, to promote such lifestyles in their patients. The objective of the present study is to ascertain the perceptions of clinicians and researchers within the Basque Health System of the factors that hinder or facilitate the integration of healthy lifestyle promotion in routine PHC setting. Methods Formative research based on five consensus meetings held by an expert panel of 12 PHC professionals with clinical and research experience in health promotion, supplied with selected bibliographic material. These meetings were recorded, summarized and the provisional findings were returned to participants in order to improve their validity. Results The Health Belief Model, the Theory of Planned Action, the Social Learning Theory, "stages of change" models and integrative models were considered the most useful by the expert panel. Effective intervention strategies, such as the "5 A's" strategy (assess, advise, agree, assist and arrange) are also available. However, none of these can be directly implemented or continuously maintained under current PHC conditions. These strategies should therefore be redesigned by adjusting the intervention objectives and contents to the operation of primary care centres and, in turn, altering the organisation of the centres where they are to be implemented. Conclusion It is recommended to address optimisation of health promotion in PHC from a research perspective in which PHC professionals, researchers and managers of these services cooperate in designing and evaluating innovative programs. Future strategies should adopt a socio-ecological approach in which the health system plays an essential role but which nevertheless complements other individual, cultural and social factors that condition health. These initiatives require an adequate theoretical and methodological framework for designing and evaluating complex interventions.

Abstract Background Counselling in routine general practice to promote physical activity (PA) is advocated, but inadequate evidence is available to support this intervention, and its sustainable implementation over time is difficult. Objectives To describe the characteristics of physically inactive adults visiting GPs and the factors associated with their willingness to change PA. Methods A cross-sectional analysis of 4317 Spanish people aged 20–80 years, selected by systematic sampling among those attending 56 public primary health care practices identified as inactive by their GPs in 2003. PA (7-day PAR), PA stage of change, health-related quality of life (SF-36), cardiovascular risk factors, and social and demographic characteristics were measured. Multivariate mixed effects ordinal logistic models were adjusted to identify factors associated with motivational readiness to change. Results At least 70% (95% CI: 67.6% to 72.8%) of patients assessed by GPs did not achieve minimal PA recommendations. In addition, 85% (95% CI: 83% to 86.3%) had at least an additional cardiovascular risk factor. Only 30% (95% CI: 25.8% to 33.5%) were prepared for or attempting a change. A younger age; retirement or work at home; higher education and social class levels; obesity; and hypertension were associated with a higher motivational readiness to change (p < 0.05). Conclusion The overburden that would result from counselling such a high proportion of inactive primary care patients justifies a targeted strategy for PA promotion in family practice. Selection of a target population based on readiness to change, the combination of risk factors and socio-demographic characteristics of patients is suggested in order to prioritise promotion efforts.

Abstract Background Antenatal education (AE) started more than 30 years ago with the purpose of decreasing pain during childbirth. Epidural anaesthesia has achieved this objective, and the value of AE is therefore currently questioned. This article describes the protocol and process of a study designed to assess AE results today. Methods/Design A prospective study was designed in which a cohort of 616 nulliparous pregnant women attending midwife offices of the Basque Health Service were followed for 13 months. Three exposure groups were considered based on the number of AE sessions attended: (a) women attending no session, (b) women attending 1 to 4, and (c) women attending 5 or more sessions. Sociodemographic, personality, and outcome variables related to childbirth and breastfeeding were measured. It was expected 40% of pregnant women not to have participated in any AE session. However, 93% had attended at least one session. This low exposure variability decreased statistical power of the study as compared to the initially planned power. Despite this, there was a greater than 80% power for detecting as significant differences between exposure groups of, for instance, 10% in continuation of breastfeeding at one and a half months and in visits for false labour. Women attending more sessions were seen to have a mean higher age and educational level, and to belong to a higher socioeconomic group (p < 0.01). Follow-up was completed in 99% of participants. Discussion Adequate prior estimation of variability in the exposure under study is essential for designing cohort studies. Sociodemographic characteristics may play a confounding role in studies assessing AE and should be controlled in design and analyses. Quality control during the study process and continued collaboration from both public system midwives and eligible pregnant women resulted in a negligible loss rate.

Background: Quality of life (QoL) decreases as heart failure worsens, which is one of the greatest worries of these patients. Physical exercise has been shown to be safe for people with heart failure. Previous studies have tested heterogeneous exercise programs using different QoL instruments and reported inconsistent effects on QoL. The aim of this study is to evaluate the effectiveness of a new exercise program for people with heart failure (EFICAR), additional to the recommended optimal treatment in primary care, to improve QoL, functional capacity and control of cardiovascular risk factors.Methods/design: Multicenter clinical trial in which 600 patients with heart failure in NYHA class II-IV will be randomized to two parallel groups: EFICAR and control. After being recruited, through the reference cardiology services, in six health centres from the Spanish Primary Care Prevention and Health Promotion Research Network (redIAPP), patients are followed for 1 year after the beginning of the intervention. Both groups receive the optimized treatment according to the European Society of Cardiology guidelines. In addition, the EFICAR group performs a 3 month supervised progressive exercise program with an aerobic (high-intensity intervals) and a strength component; and the programme continues linked with community resources for 9 months. The main outcome measure is the change in health-related QoL measured by the SF-36 and the Minnesota Living with Heart Failure Questionnaires at baseline, 3, 6 and 12 months. Secondary outcomes considered are changes in functional capacity measured by the 6-Minute Walking Test, cardiac structure (B-type natriuretic peptides), muscle strength and body composition. Both groups will be compared on an intention to treat basis, using multi-level longitudinal mixed models. Sex, age, social class, co-morbidity and cardiovascular risk factors will be considered as potential confounding and predictor variables.Discussion: A key challenges of this study is to guarantee the safety of the patients; however, the current scientific evidence supports the notion of there being no increase in the risk of decompensation, cardiac events, hospitalizations and deaths associated with exercise, but rather the opposite. Safety assurance will be based on an optimized standardised pharmacological therapy and health education for all the participants.Trial Registration: Clinical Trials.gov Identifier: NCT01033591. [ABSTRACT FROM AUTHOR]

Background: The adoption of a healthy lifestyle, including physical activity, a balanced diet, a moderate alcohol consumption and abstinence from smoking, are associated with large decreases in the incidence and mortality rates for the most common chronic diseases. That is why primary health care (PHC) services are trying, so far with less success than desirable, to promote healthy lifestyles among patients. The objective of this study is to design and model, under a participative collaboration framework between clinicians and researchers, interventions that are feasible and sustainable for the promotion of healthy lifestyles in PHC.Methods and Design: Phase I formative research and a quasi-experimental evaluation of the modelling and planning process will be undertaken in eight primary care centres (PCCs) of the Basque Health Service--OSAKIDETZA, of which four centres will be assigned for convenience to the Intervention Group (the others being Controls). Twelve structured study, discussion and consensus sessions supported by reviews of the literature and relevant documents, will be undertaken throughout 12 months. The first four sessions, including a descriptive strategic needs assessment, will lead to the prioritisation of a health promotion aim in each centre. In the remaining eight sessions, collaborative design of intervention strategies, on the basis of a planning process and pilot trials, will be carried out. The impact of the formative process on the practice of healthy lifestyle promotion, attitude towards health promotion and other factors associated with the optimisation of preventive clinical practice will be assessed, through pre- and post-programme evaluations and comparisons of the indicators measured in professionals from the centres assigned to the Intervention or Control Groups.Discussion: There are four necessary factors for the outcome to be successful and result in important changes: (1) the commitment of professional and community partners who are involved; (2) their competence for change; (3) the active cooperation and participation of the interdisciplinary partners involved throughout the process of change; and (4) the availability of resources necessary to facilitate the change. [ABSTRACT FROM AUTHOR]

Background: Counselling in routine general practice to promote physical activity (PA) is advocated, but inadequate evidence is available to support this intervention, and its sustainable implementation over time is difficult.Objectives: To describe the characteristics of physically inactive adults visiting GPs and the factors associated with their willingness to change PA.Methods: A cross-sectional analysis of 4317 Spanish people aged 20-80 years, selected by systematic sampling among those attending 56 public primary health care practices identified as inactive by their GPs in 2003. PA (7-day PAR), PA stage of change, health-related quality of life (SF-36), cardiovascular risk factors, and social and demographic characteristics were measured. Multivariate mixed effects ordinal logistic models were adjusted to identify factors associated with motivational readiness to change.Results: At least 70% (95% CI: 67.6% to 72.8%) of patients assessed by GPs did not achieve minimal PA recommendations. In addition, 85% (95% CI: 83% to 86.3%) had at least an additional cardiovascular risk factor. Only 30% (95% CI: 25.8% to 33.5%) were prepared for or attempting a change. A younger age; retirement or work at home; higher education and social class levels; obesity; and hypertension were associated with a higher motivational readiness to change (p < 0.05).Conclusion: The overburden that would result from counselling such a high proportion of inactive primary care patients justifies a targeted strategy for PA promotion in family practice. Selection of a target population based on readiness to change, the combination of risk factors and socio-demographic characteristics of patients is suggested in order to prioritise promotion efforts. [ABSTRACT FROM AUTHOR]

ABSTRACT: BACKGROUND: Antenatal education (AE) started more than 30 years ago with the purpose of decreasing pain during childbirth. Epidural anaesthesia has achieved this objective, and the value of AE is therefore currently questioned. This article describes the protocol and process of a study designed to assess AE results today. METHODS/DESIGN: A prospective study was designed in which a cohort of 616 nulliparous pregnant women attending midwife offices of the Basque Health Service were followed for 13 months. Three exposure groups were considered based on the number of AE sessions attended: (a) women attending no session, (b) women attending 1 to 4, and (c) women attending 5 or more sessions. Sociodemographic, personality, and outcome variables related to childbirth and breastfeeding were measured.It was expected 40% of pregnant women not to have participated in any AE session. However, 93% had attended at least one session. This low exposure variability decreased statistical power of the study as compared to the initially planned power. Despite this, there was a greater than 80% power for detecting as significant differences between exposure groups of, for instance, 10% in continuation of breastfeeding at one and a half months and in visits for false labour. Women attending more sessions were seen to have a mean higher age and educational level, and to belong to a higher socioeconomic group (p < 0.01). Follow-up was completed in 99% of participants. DISCUSSION: Adequate prior estimation of variability in the exposure under study is essential for designing cohort studies. Sociodemographic characteristics may play a confounding role in studies assessing AE and should be controlled in design and analyses. Quality control during the study process and continued collaboration from both public system midwives and eligible pregnant women resulted in a negligible loss rate. [ABSTRACT FROM AUTHOR]

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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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.

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 (χ 2  = 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., (© 2023. BioMed Central Ltd.)

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., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Gonzalo Grandes Odriozola reports financial support was provided by Carlos III Health Institute., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

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.

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 VO 2 max 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 VO 2 max 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.

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/m 2 (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., (Copyright © 2022 The Author(s). Publicado por Elsevier España, S.L.U. All rights reserved.)

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 VO 2peak ; 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.

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., Competing Interests: Conflict of interestThe authors declare that they have no conflict of interest., (© The Author(s) 2022.)

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., (© The Authors.)

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., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Sanchez, Elizondo-Alzola, Pijoan, Mediavilla, Pablo, Sainz de Rozas, Lekue, Gonzalez-Larragan, Llarena, Larrañaga, Helfrich and Grandes.)

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., (Copyright © 2022 The Authors. Publicado por Elsevier España, S.L.U. All rights reserved.)

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., (© Heather L. Rogers, Susana Pablo Hernando, Silvia Núñez - Fernández, Alvaro Sanchez, Carlos Martos, Maribel Moreno and Gonzalo Grandes.)

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., (©Maria Soledad Arietaleanizbeaskoa, Erreka Gil Rey, Nere Mendizabal Gallastegui, Arturo García-Álvarez, Ibon De La Fuente, Silvia Domínguez-Martinez, Susana Pablo, Aitor Coca, Borja Gutiérrez Santamaría, Gonzalo Grandes. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 09.08.2021.)

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.

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.

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., (© 2021 The Authors. The Journal of Clinical Hypertension published by Wiley Periodicals LLC.)

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.

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.

Background: De-implementation or abandonment of ineffective or low-value healthcare is becoming a priority research field globally due to the growing empirical evidence of the high prevalence of such care and its impact in terms of patient safety and social inefficiency. Little is known, however, about the factors, barriers, and facilitators involved or about interventions that are effective in promoting and accelerating the de-implementation of low-value healthcare. The De-imFAR study seeks to carry out a structured, evidence-based, and theory-informed process involving the main stakeholders (clinicians, managers, patients, and researchers) for the design, deployment, and assessment of de-implementation strategies for reducing low-value pharmacological prescribing., Methods: A phase I formative study using a systematic and comprehensive framework based on theory and evidence for the design of implementation strategies-specifically, the Behavior Change Wheel (BCW)-will be conducted to design and model de-implementation strategies to favor reductions in low-value pharmacological prescribing of statins in primary prevention of cardiovascular disease (CVD) by main stakeholders (clinicians, managers, patients, and researchers) in a collegiate way. Subsequently, a phase II comparative hybrid trial will be conducted to assess the feasibility and potential effectiveness of at least one active de-implementation strategy to reduce low-value pharmacological prescribing of statins in primary prevention of CVD compared to the usual procedures for dissemination of clinical practice guidelines ("what-not-to-do" recommendations). A mixed-methods evaluation will be used: quantitative for the results of the implementation at the professional level (e.g., adoption, reach and implementation or execution of the recommended clinical practice); and qualitative to determine the feasibility and perceived impact of the de-implementation strategies from the clinicians' perspective, and patients' experiences related to the clinical care received., Discussion: The DE-imFAR study aims to generate valid scientific knowledge about the design and development of de-implementation strategies using theory- and evidence-based methodologies suggested by implementation science. It will explore the effectiveness of these strategies and their acceptability among clinicians, policymakers, and patients. Its ultimate goal is to maximize the quality and efficiency of our health system by abandoning low-value pharmacological prescribing., Trial Registration: Clinicaltrials.gov identifier: NCT04022850. Registered 17 July 2019.

Background: Elbow tendinopathies are associated with tenderness, pain, and functional disability with ensuing socioeconomic costs. There is lack of consensus regarding the best treatment for patients recalcitrant to first-line conservative treatments. Percutaneous needle tenotomy is considered a regenerative approach that injures the tendon to elicit a healing response., Objective: To investigate whether demographic characteristics, clinical factors, baseline sonographic entities, or their interactions are related to the likelihood of responding positively to needle tenotomy over a 1-year follow-up period., Design: Prospective case series., Setting: Tertiary institutional hospital., Participants: Patients with elbow tendinopathy for whom conservative treatments had failed and who had persistent symptoms lasting for at least 3 months., Methods: Patients underwent needle tenotomy with or without PRP followed by a lighter needle tenotomy within a 2-week interval as part of treatment., Main Outcome Measurements: Disabilities of the Arm, Shoulder and Hand (DASH) and Visual Analogue Scale for pain (VAS-P) scores were assessed before intervention (baseline) and at 6 weeks and 3, 6, and 12 months after intervention. A generalized linear mixed effects model was created to examine whether injectate type, clinical, demographic, or pretreatment sonographic entities or their interactions influenced clinical outcomes., Results: The authors analyzed 74 elbows (71 patients). At baseline, analyzed patients (mean age: 49.48 years; 51.35% women) scored 43.30 and 5.83 on the DASH and VAS-P, respectively. Pretreatment tendon vascularization was a predictor of pain (P = .011) and DASH score changes (P = .019). The linear mixed effect model revealed that male gender and hypercholesterolemia were associated with enhanced functional recovery, (P = .020 and P < .001, respectively). Moreover, the interactions between pretreatment vascular status (P = .039), echotexture (P = .037) and enthesophytes (P = .028) influenced the temporal pattern of functional recovery after needle tenotomy., Conclusions: Baseline patient characteristics, such as gender and hypercholesterolemia, along with ultrasound features may be predictive of outcomes following needle tenotomy for elbow tendinopathy., Level of Evidence: IV (NCT01945528)., (© 2019 American Academy of Physical Medicine and Rehabilitation.)

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.