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

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

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

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

Long-term health related quality of life in total knee arthroplasty.

BACKGROUND: To analyze evolution and factors related with greater gains in Health Related Quality of Life (HRQOL) and with a greater probability of exceed their corresponding minimal clinically important differences (MCID) in patients with Osteoarthritis of the knee, undergoing total knee arthroplasty (TKA) at long-term. METHODS: Data were obtained from two previously recruited multicenter cohorts of patients who underwent TKA in the Basque Country. Patients were follow-up at 6 months and 10 years after surgery. Patients completed specific and generic HRQOL questionnaires plus sociodemographic, and clinical data at 10 years. Associations were analysed using linear and logistic regression models. RESULTS: A total of 471 patients responded at 10-year follow-up. The multivariable analysis showed that low preoperative HRQOL scores, higher age, higher BMI, some comorbidities and readmissions at 6 months were associated with less gains in HRQOL. Apart from aforementioned, to have a peripheral vascular disease (odd ratio 0.49 (95% CI, 0.24-0.99)), complications (odd ratio 0.31 (95% CI, 0.11-0.91)), and readmissions within 6 months of discharge (odd ratio 2.12 (95% CI, 1.18-3.80)) were associated with a lower probability of exceeding the MCID. The effect sizes (ESs) of changes from baseline to 6 months (range, 1.20-1.96) and to 10 years (range, 1.54-1.99) were large in all dimensions, nevertheless the ESs from 6 months to 10 years were not appreciable for pain (ES = 0.03) or stiffness (ES = 0.09), and small for function (ES = 0.30). CONCLUSIONS: Low preoperative HRQOL scores, to be elderly, severe obesity, the presence of some comorbidities -depression and rheumatology disease-, having readmissions or complications and not having rehabilitation of discharge, are good predictors of long-term lower gains in HRQOL. Some other non-registered parameters of the follow-up may also influence those outcomes. KEY INDEXING TERMS (MESH TERMS): Health-Related Quality of Life, Knee Arthroplasty, Total, Osteoarthritis.

Validation of the Mini-OAKHQOL for use in patients with osteoarthritis in Spain.

The Mini-Osteoarthritis Knee and Hip Quality of Life (Mini-OAKHQOL) questionnaire osteoarthritis is specific to individuals with knee or hip osteoarthritis. The objective of this study was to perform a validation of the Mini-OAKHQOL for use in Spain in terms of its psychometric properties of reliability, validity and responsiveness. Patients with osteoarthritis from the waiting list for a joint replacement completed the OAKHQOL, Short Form 36 Health Survey and Western Ontario and McMaster Universities Osteoarthritis Index. Reliability was assessed in terms of internal consistency and test-retest data, and convergent validity using Spearman's correlation coefficient. Structural validity was investigated by confirmatory factor analysis, and Rasch analysis was used to examine the unidimensionality of the scales. Responsiveness was assessed by calculating effect sizes. Confirmatory factor analysis confirmed the five-factor model, and the results of the Rasch analyses supported the unidimensionality assumption, with infit and outfit statistics. Cronbach's alpha ranged from 0.76 to 0.89 for all except the social dimensions. Statistically significant differences were observed between patients with different degrees of disease severity on all dimensions. There was convergent validity among dimensions expected to be correlated. The OAKHQOL questionnaire showed good responsiveness, with large changes for all dimensions apart from the two social dimensions, which had small effect sizes. Results of the study support the view that the Spanish version of the Mini-OAKHQOL questionnaire is a valid instrument to measure health-related quality of life in patients with osteoarthritis of the lower limb.

A prospective study of the association of patient expectations with changes in health-related quality of life outcomes, following total joint replacement.

BACKGROUND: Patient expectations regarding surgery may be related to outcomes in total joint replacement (TJR). The aim of this study was to determine the association of patient expectations with health related quality of life (HRQoL) outcomes measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Short Form 12 (SF-12) and satisfaction with current symptoms measured on a 4-point Likert scale, one year after surgery, adjusting for Body Mass Index (BMI), age, gender, joint, education, previous intervention and baseline scores. METHODS: Consecutive patients preparing for TJR of the knee or hip due to primary osteoarthritis (OA) in 15 hospitals in Spain were recruited for the study. Patients completed questionnaires before surgery and 12 months afterwards: five questions about expectations before surgery; an item to measure satisfaction; two HRQoL instruments-WOMAC and SF-12; as well as questions about sociodemographic information. To determine the association of patient expectations at baseline, with changes in HRQoL 12 months after surgery and with satisfaction, general linear models and logistic regression analysis were performed. RESULTS: A total of 892 patients took part in the study. Patients who had higher pain relief or ability to walk expectations improved more in HRQoL at 12 months. Moreover, patients with high daily activity expectations were more satisfied. CONCLUSIONS: Patients with higher baseline expectations for TJR, improved more in HRQoL at one year and had more likelihood to be satisfied than patients with lower expectations, adjusted for BMI, age, gender, joint, education, previous intervention and HRQoL baseline scores.

Adaptation and validation of the Osteoarthritis Knee and Hip Quality of Life (OAKHQOL) questionnaire for use in patients with osteoarthritis in Spain.

This study aims to adapt and validate the Spanish version of the Osteoarthritis Knee and Hip Quality of Life (OAKHQOL) questionnaire. The OAKHQOL was adapted into Spanish using a forward-backward translation methodology. The Spanish version was then validated in a prospective, mixed-design study of 759 patients with hip or knee osteoarthritis (OA). Patients completed the OAKHQOL, Short Form 36 (SF-36), Western Ontario and McMaster Universities Osteoarthritis Index, and the EQ-5D. The internal consistency was evaluated using Cronbach's alpha. Convergent validity was assessed by examining correlations between the OAKHQOL and other patient-reported instruments; known groups' validity was assessed by determining the capacity of the OAKHQOL to discriminate between patients with different levels of disease severity measured using the Lequesne Index. Test-retest reliability was evaluated by calculating the intraclass correlation coefficient (ICC) for all OAKHQOL domains in 409 stable patients with OA. Responsiveness was evaluated by calculating effect sizes among 129 patients undergoing hip or knee replacement. Cronbach's alpha for the five domains of the OAKHQOL ranged from 0.60 to 0.93 while ICCs ranged from 0.75 to 0.81 for all domains except the two social domains. Statistically significant differences (p < 0.001) were observed between patients with different degrees of disease severity on all domains except "social support". The instrument showed convergent validity among hypothesized domains (p < 0.001). Results of the study supported that the Spanish version OAKHQOL questionnaire was a valid instrument to measure health-related quality of life in patients with OA of the lower limb.

Patient expectations and health-related quality of life outcomes following total joint replacement.

OBJECTIVES: Patient psychological factors have been linked to health-related quality of life (HRQoL) outcomes after total joint replacement (TJR). We evaluated the relationship between patient expectations before TJR, their fulfillment and HRQoL outcomes at 3 and 12 months after surgery. METHODS: Consecutive patients preparing for TJR of the knee or hip due to primary osteoarthritis in 15 hospitals in Spain were recruited for the study. Patients completed questionnaires before surgery, and 3 and 12 months afterward: five questions about expectations before surgery and their fulfillment at 3 and 12 months; three HRQoL instruments-Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Short Form 12 (SF-12), and European Quality of Life Instrument (EQ-5D); as well as questions about sociodemographic information. Student's t test was used to assess the relationship between fulfillment of expectations and gains in HRQoL. RESULTS: A total of 881 patients took part in the study. Preintervention expectations for TJR ranged from 85% to 86% of patients, with high expectations for pain relief and ability to walk to 70% with high expectations about interacting with others. Patients who reported having fulfilled their expectations at 3 and 12 months had significantly greater gains in HRQoL than those who did not. Besides, we observed a statistically significant improvement in the percentage of patients who fulfill their expectations from 3 to 12 months. CONCLUSIONS: Patients have high expectations for the benefits of TJR, and those who fulfill their expectations have greater gains in HRQoL assessing by SF-12, WOMAC and EQ-5D. Health-care providers should help their patients develop realistic expectations about the impact of TJR.