Arturo García-Álvarez

The DE-imFAR study aims to compare the effectiveness of several de-implementation strategies targeting clinicians' decision-making processes to reduce potentially inappropriate prescribing (PIP) of statins for cardiovascular disease (CVD) primary prevention. A partially randomized, cluster implementation trial with an active comparator group, involving family physicians (FPs) with non-zero incidence rates of PIP of statins in 2021, was conducted in 13 integrated healthcare organizations (IHOs) in the Basque Health Service. All eligible FPs (n = 621) were exposed to (1) a non-reflective decision assistance (DA) strategy based on reminders. FPs from two IHOs were randomized to additionally receive one of two increasingly intensive reflective strategies: (2) a knowledge dissemination decision information (DI) strategy (n = 59), or (3) a DI strategy plus audit and feedback (A&F) self-reflective decision (SRD) strategy (n = 59). The main outcome was the change from baseline to 12 months after deployment in the likelihood of receiving new PIP of statins and advice on lifestyle modifications, estimated with generalized mixed effects models, in 45- to 74-year-old low cardiovascular risk patients with elevated cholesterol levels but no diagnosed CVD. After FPs' exposure to the corresponding strategies, rates of statin PIP decreased significantly in all groups (p < 0.001). Concerning study's main observational comparisons between strategies, though the reduction obtained by the DI and SRD strategies were 33% (adjusted OR: 0.77; 95% CI: 0.58-1.01) and 6% (aOR: 0.94; 95% CI: 0.73-1.23) higher compared to the change from the DA, estimated differences did not reach statistical significance (p = 0.07). When comparing the two reflective strategies together (DI + SRD) with the non-reflective (DA), a significant difference (p = 0.038) was observed, being the odds of receiving PIP of statins 19% lower (aOR: 0.81; 95% CI: 0.66-0.99). In the experimental comparison between reflective strategies (SRD vs. DI), providing A&F to FPs showed no additional effect (p = 0.30). De-implementation strategies that targeted clinical decision-making were effective in reducing PIP of statins for CVD primary prevention. Strategies that targeted reflective thinking and increased awareness of low-value prescribing showed a trend toward greater effectiveness. ClinicalTrials.gov Identifier NCT04022850. Registered 17 July 2019.

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.

How individuals perceive and cope with stressful situations may determine their level of anxiety or depression. The identification of coping strategies (CS) in pregnancy could help prevent depression and anxiety (D&A), and their consequent effects on the health of the mother and the baby. A cross-sectional descriptive correlational study was conducted to identify the CS most commonly used by pregnant women in a Spanish population and to evaluate the association of these CS with D&A. A consecutive sample of 282 pregnant women over 18 years of age were recruited when attended midwife consultations and through snowball sampling between December 2019 and January 2021 in the Basque public health system. CS were measured using the RevisedPrenatal Coping Inventory (NuPCI) questionnaire, assigning the score to an avoidant, preparatory or spiritual scale. Cutoff points were established to categorize anxiety and depressive symptomatology, using the STAI-S and EPDS scales. Multivariate logistic regression models were constructed to analyze the association between CS and D&A. The results show that the higher the score on the avoidance subscale, the higher the likelihood of having an anxiety disorder (OR: 8.88 (95 percent Confidence Interval [CI] 4.26–20.1), and depressive symptoms (OR: 8.29 (95 percent CI 4.24–17.4). Multiparous women are more likely to have anxiety (OR: 3.41 (95 percent CI 1.58–7.5) or depressive symptomatology (OR: 4.1 (95 percent CI 2.04–8.53) during pregnancy. These results highlight the need to consider the evaluation of CS used during pregnancy to tailor the care provided, but further studies on the implementation and effectiveness of interventions are needed.

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.

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

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.

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. CLINICALTRIAL ClinicalTrials.gov NCT03819595; http://clinicaltrials.gov/ct2/show/NCT03819595 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/24835

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

Several studies have shown that evening intake of aspirin has antihypertensive effect in healthy adults, which has not been proven in patients with cardiovascular disease, who mostly take aspirin in the morning. We have evaluated the antihypertensive effect of bedtime administration of aspirin in patients with cardiovascular disease already treated for hypertension. This is a multicenter randomized triple-blind placebo-controlled crossover trial, with hypertensive patients treated with aspirin for secondary prevention. There was a baseline-randomized assignment to 2-month periods of bedtime aspirin (100 mg) first and morning-time aspirin later, or inversely, both periods separated by an open label 2–4 weeks period of morning-time aspirin. At the start and end of each treatment period, a 24-h ambulatory blood pressure monitoring was performed. The main outcome measure was mean 24-h blood pressure. The analyses were performed according to the intention-to-treat principle. Overall, 225 patients were randomized. No significant differences were observed in ambulatory blood pressure by time of intake of usual low doses of aspirin. The mean SBP/DBP was 123.2/69.9 (95% CI 121.58–124.9/68.86–76.86) with bedtime administration and 122.4/68.8 (95% CI 120.76–124.01/67.85–69.83) with daytime administration (P = 0.3 and P = 0.23 for SBP and DBP, respectively). Administering aspirin at bedtime rather than in the morning does not modify the 24-h ambulatory blood pressure in hypertensive patients in secondary cardiovascular prevention. The trial was registered with ClinicalTrials.gov (number NCT01741922).