Effect of tailored educational intervention to improve self-care maintenance and quality of life in postmenopausal osteoporotic women after a fragility fracture: the Guardian Angel® study.

Osteoporosis has a significant impact on affected patients. Healthcare providers should encourage postmenopausal women to improve self-care maintenance behaviors and quality of life following a fragility fracture. The aims of this study were to a) develop two new instruments for measuring, respectively, self-care maintenance and quality of life, in postmenopausal women with osteoporosis; b) evaluate the effectiveness of a tailored educational intervention to improve self-care maintenance and quality of life after a fragility fracture in postmenopausal women. For the first aim, a cross-sectional study will be performed; for the second aim, a multicenter, quasi-experimental, interventional design will be used. A convenience sample of postmenopausal women admitted to 44 hospitals in Italy with a diagnosis of bone fragility fracture will be enrolled and surveyed at 7, 30, 60 and 180 days after discharge. Trained nurses will conduct the educational intervention. The new instruments will allow the measurement of self-care and quality of life in postmenopausal women following a fragility fracture. Through tailored educational interventions, women can be helped to take their medications correctly, adopt a healthy lifestyle, reduce the occurrence of bone fractures, and have a better quality of life.

Bone care nurses and the evolution of the nurse's educational function: the Guardian Angel(®) research project.

Osteoporosis mostly affects females over 50 years old, worldwide. The main osteoporosis complication is fragility fractures that reduce quality of life and cause morbidity and mortality. Most patients who have fragility fractures are treated for the fracture. However, patients' adherence to follow-up treatment plans is poor. Therefore, tailored educational interventions are needed to improve medication adherence and healthy lifestyles. In this context, the role of bone care nurses is important, as they can act at different levels of osteoporosis prevention and fracture liaison services, which are secondary fracture prevention programmes implemented by health care systems to treat osteoporotic patients. In Italy, a research project called Guardian Angel(®) was developed to provide tailored education to osteoporotic women in order to improve their disease management and reduce related complications.

Factors That Influence Quality of Life in Postmenopausal Osteoporotic Women With Nonvertebral Fractures: The Guardian Angel Multicenter Longitudinal Study.

The knowledge of variables associated with quality of life in women with nonvertebral fractures is poor. The aim of this study was to examine the independent associations between sociodemographic and clinical factors, self-care, and quality of life in this specific population. We undertook a 3-year multicenter longitudinal study on a cohort of Italian postmenopausal osteoporotic women with three follow-ups at 1, 3, and 6 months. Nurses asked women to complete questionnaires on quality of life and self-care. The sample (n = 532) had a mean age of 74.78 years. The results showed that women taking more than two medications per day (p = .026) and those with nine or more years of education (p = .036) were more likely to exhibit better quality of life levels (p < .001) than their counterparts. Both self-care and quality of life scores improved over time in all participants. This study shows positive independent associations between quality of life and polypharmacy, education, and self-care behaviors, which were improved by educational interventions to attain a better quality of life in our participants.

The sequential antifracturative treatment: a meta-analysis of randomized clinical trials.

Background: Subjects with a fragility fracture have an increased risk of a new fracture and should receive effective strategies to prevent new events. The medium-term to long-term strategy should be scheduled by considering the mechanisms of action in therapy and the estimated fracture risk. Objective: A systematic review was conducted to evaluate the sequential strategy in patients with or at risk of a fragility fracture in the context of the development of the Italian Guidelines. Design: Systematic review and meta-analysis. Data sources and methods: PubMed, Embase, and the Cochrane Library were investigated up to February 2021 to update the search of a recent systematic review. Randomized clinical trials (RCTs) that analyzed the sequential therapy of antiresorptive, anabolic treatment, or placebo in patients with or at risk of a fragility fracture were eligible. Three authors independently extracted data and appraised the risk of bias in the included studies. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation methodology. Effect sizes were pooled in a meta-analysis using fixed-effects models. The primary outcome was the risk of refracture, while the secondary outcome was the bone mineral density (BMD) change. Results: In all, 17 RCTs, ranging from low to high quality, met our inclusion criteria. A significantly reduced risk of fracture was detected at (i) 12 or 24 months after the switch from romosozumab to denosumab versus placebo to denosumab; (ii) 30 months from teriparatide to bisphosphonates versus placebo to bisphosphonates; and (iii) 12 months from romosozumab to alendronate versus the only alendronate therapy (specifically for vertebral fractures). In general, at 2 years after the switch from anabolic to antiresorptive drugs, a weighted BMD was increased at the lumbar spine, total hip, and femoral neck site. Conclusion: The Task Force formulated recommendations on sequential therapy, which is the first treatment with anabolic drugs or 'bone builders' in patients with very high or imminent risk of fracture.

A systematic review to evaluate the sequential therapy of antiresorptive (denosumab and bisphosphonate, such as alendronate, minodronate, risedronate, and etidronate), anabolic treatment (such as romosozumab, teriparatide), or placebo in patients with or at risk of a fragility fracture in the context of the development of the Italian Guidelines Subjects with previous fragility fractures should promptly receive effective strategies to prevent the risk of subsequent events. Indeed, patients with a fragility fracture have a doubled risk of a new fracture. For this reason, it is essential to provide adequate sequential therapy based on the mechanisms and the rapidity of action. A systematic review was performed to identify the sequential strategy in patients at high- or imminent-risk of (re)fracture and to support the Panel of the Italian Fragility Fracture Guideline in formulating recommendations. Our systematic review included seventeen studies mostly focused on women and enabled us to strongly recommend the anabolic drugs as first-line treatment. Specifically, for the sequential therapy from anabolic to antiresorptive treatment, there was a significant reduction in the risk of different types of fractures after the switch from romosozumab to denosumab versus placebo to denosumab. These findings were confirmed at 24 months after the switch. Considering the sequential treatment from antiresorptive to anabolic medications, there was a decreased risk of fracture 12 months after the switch from placebo to teriparatide versus bisphosphonate or antiresorptive to teriparatide. Moreover, a greater bone mineral density increase after the switch from anabolic to antiresorptive medications was shown in the lumbar spine, total hip, and femoral neck. The results of this systematic review and meta-analysis confirm that initial treatment with anabolic drugs produces substantial bone mineral density improvements, and the transition to antiresorptive drugs can preserve or even amplify the acquired benefit. These findings support the choice to treat very high-risk individuals with anabolic drugs first, followed by antiresorptive drugs.

Is the Self-Evaluation of Resilience a Valid Assessment to Measure Resilience in Healthcare? A Confirmatory validation Study in Italian Healthcare Settings.

Although the Self-Evaluation of Resilience (SEOR) scale is a promising tool for assessing resilience in healthcare, its psychometric structure has not yet been confirmed. This study aimed to assess and validate the four-factor psychometric structure of the SEOR. Between September 2020 and January 2021, cross-sectional data were collected from randomly selected healthcare workers, managers, and administrators from a predefined network of 70 healthcare facilities in 12 Italian regions. The sample size was based on a Monte Carlo simulation using estimates from the SEOR developmental study. Two confirmatory factor models (first-order and second-order) were predefined. The responders (n = 199, response rate, 81%) were healthcare workers (n = 99; 49.7%), managers (n = 86; 43.2%), and administrators (n = 14; 7%). The two confirmatory factor models each showed a good fit in explaining sample statistics, corroborating the capacity of the scale to provide a total score of resilience and sub-scores for organizational resilience, network-based resilience, skill-based resilience, and individual-based resilience. The Molenaar-Sijtsma coefficients (internal consistency) ranged between 0.889 and 0.927. The SEOR enables managers and policy-makers to comprehensively screen resilience in healthcare from an epidemiological perspective.

Executive summary: Italian guidelines for diagnosis, risk stratification, and care continuity of fragility fractures 2021.

Background: Fragility fractures are a major public health concern owing to their worrying and growing burden and their onerous burden upon health systems. There is now a substantial body of evidence that individuals who have already suffered a fragility fracture are at a greater risk for further fractures, thus suggesting the potential for secondary prevention in this field. Purpose: This guideline aims to provide evidence-based recommendations for recognizing, stratifying the risk, treating, and managing patients with fragility fracture. This is a summary version of the full Italian guideline. Methods: The Italian Fragility Fracture Team appointed by the Italian National Health Institute was employed from January 2020 to February 2021 to (i) identify previously published systematic reviews and guidelines on the field, (ii) formulate relevant clinical questions, (iii) systematically review literature and summarize evidence, (iv) draft the Evidence to Decision Framework, and (v) formulate recommendations. Results: Overall, 351 original papers were included in our systematic review to answer six clinical questions. Recommendations were categorized into issues concerning (i) frailty recognition as the cause of bone fracture, (ii) (re)fracture risk assessment, for prioritizing interventions, and (iii) treatment and management of patients experiencing fragility fractures. Six recommendations were overall developed, of which one, four, and one were of high, moderate, and low quality, respectively. Conclusions: The current guidelines provide guidance to support individualized management of patients experiencing non-traumatic bone fracture to benefit from secondary prevention of (re)fracture. Although our recommendations are based on the best available evidence, questionable quality evidence is still available for some relevant clinical questions, so future research has the potential to reduce uncertainty about the effects of intervention and the reasons for doing so at a reasonable cost.

Medication holidays in osteoporosis: evidence-based recommendations from the Italian guidelines on 'Diagnosis, risk stratification, and continuity of care of fragility fractures' based on a systematic literature review.

Background: Noncommunicable, chronic diseases need pharmacological interventions for long periods or even throughout life. The temporary or permanent cessation of medication for a specific period, known as a 'medication holiday,' should be planned by healthcare professionals. Objectives: We evaluated the association between continuity (adherence or persistence) of treatment and several outcomes in patients with fragility fractures in the context of the development of the Italian Guidelines. Design: Systematic review. Data Sources and Methods: We systematically searched PubMed, Embase, and the Cochrane Library up to November 2020 for randomized clinical trials (RCTs) and observational studies that analyzed medication holidays in patients with fragility fracture. Three authors independently extracted data and appraised the risk of bias of the included studies. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation methodology. Effect sizes were pooled in a meta-analysis using random effects models. Primary outcomes were refracture and quality of life; secondary outcomes were mortality and treatment-related adverse events. Results: Six RCTs and nine observational studies met our inclusion criteria, ranging from very low to moderate quality. The adherence to antiosteoporotic drugs was associated with a lower risk of nonvertebral fracture [relative risk (RR) 0.42, 95% confidence interval (CI) 0.20-0.87; three studies] than nonadherence, whereas no difference was detected in the health-related quality of life. A reduction in refracture risk was observed when continuous treatment was compared to discontinuous therapy (RR 0.49, 95% CI 0.25-0.98; three studies). A lower mortality rate was detected for the adherence and persistence measures, while no significant differences were noted in gastrointestinal side effects in individuals undergoing continuous versus discontinuous treatment. Conclusion: Our findings suggest that clinicians should promote adherence and persistence to antiosteoporotic treatment in patients with fragility fractures unless serious adverse effects occur.

Factors influencing self-care in postmenopausal women with osteoporosis: The Guardian Angel® multicentric longitudinal study.

OBJECTIVES: To investigate the factors influencing self-care in a consecutive sample of postmenopausal osteoporotic Italian women. STUDY DESIGN: This was a multicentric, longitudinal study (Guardian Angel) conducted across several osteoporosis centres throughout Italy. MAIN OUTCOME MEASURES: Sociodemographic and clinical data (age, education, employment status, body mass index (BMI), fracture history) were collected at baseline, while self-care behaviours were assessed at baseline, and at one, three and six months from enrolment with the Self-Care of Osteoporosis Scale (SCOS). The SCOS has a total score ranging from 15 to 75 for women who take osteoporosis drugs, while for those who do not take any osteoporosis drug the score is between 13 and 65. Higher scores indicate better self-care. A three-level general linear mixed model with a random intercept for participants and regions was implemented to investigate the possible associations of the sociodemographic and clinical factors with longitudinal SCOS scores. RESULTS: The sample (n= 1525) had a mean age of 72.1 years (standard deviation [SD] = ±10.07), with a high proportion retired (64.2%) and with a low education level (45.8%). Approximately half of the women declared taking multiple medications (70.14%) and osteoporosis pharmacotherapy (69.7%). Average longitudinal SCOS scores ranged between 53.17 and 56.68, indicating a satisfactory level of self-care. There were significant and positive relationships between SCOS scores and time (p < 0.001) and number of medications taken (p < 0.001). Negative relationships were found between SCOS and BMI scores (p= 0.013), smoking status (p < 0.001) and presence of recent fractures (p < 0.001). CONCLUSIONS: Several modifiable characteristics were associated with self-care behaviours in our sample of women with postmenopausal osteoporosis. Psychoeducational interventions are promising in this population to counteract unhealthy behaviours and, ultimately, to promote self-care.

Development and Testing of the Quality of Life Osteoporosis Scale-Nonvertebral Fractures (QoLOS-NVFX).

The aim of this study was developing and testing a new tool for measuring quality of life (QoL) in patients with osteoporosis who had experienced nonvertebral fractures (NVFXs). Two main phases were carried out. First, the tool was developed based on expert opinion through three focus groups. Second, the tool was tested with exploratory factor analysis and confirmatory factor analysis in a sample of 458 postmenopausal women. The reliability of the developed Quality of Life Osteoporosis Scale-Nonvertebral Fractures (QoLOS-NVFX) was measured using Cronbach's α, maximal reliability (MR), composite reliability (CR), and average variance extracted (AVE). The QoLOS-NVFX resulted in a unidimensional scale with 23 items and showed good reliability, with a Cronbach's α of 0.94, an MR of 0.96, a CR of 0.96, and an AVE of 0.70. The QoLOS-NVFX shows good psychometric properties and can be used to assess the impact of NVFX on QoL in osteoporotic women. Furthermore, it can be easily used in clinical practice and research.

Enhancing self-resources in patients with chronic diseases: development and initial validation of the Disease and Care Management Score.

INTRODUCTION: Despite the importance of the assessment in the primary care of the self-resources among patients with chronic diseases, there is not available a measurement that allows this kind of comprehensive assessment. For this reason, the aim of this study was to develop a multi-dimensional score to determine the level of self-resources in chronic patients, describing its initial validation through face and content validity. The developed score was labelled as Disease and Care Management Score. METHODS: We performed a methodological study, encompassing two main phases. The first phase was aimed to develop the Disease and Care Management score, choosing the most suitable measurement to assess each pre-identified determinant of wellbeing in chronic patients. The second phase was aimed to determine the Disease and Care Management score face and content validity through the views of 20 experts. RESULTS: Disease and Care Management score shows evidence of face and content validity. All the obtained quantitative content validity indices (i.e. Content Validity Ratio, Content Validity Indices) were higher than 0,70, showing the pertinence and the adequacy of each pre-identified measure to compute Disease and Care Management score. CONCLUSION: Disease and Care Management score has the potential of addressing the health coaching interventions in primary care for chronic patients. Future research should show its predictive performance, as well as the cut-off to discriminate patients.

Can Educational Interventions Improve Osteoporotic Women's Adherence to Treatment? A Literature Review.

Poor adherence to medication and an unhealthy lifestyle increase risk of fracture, hospitalization, and medical costs in osteoporotic individuals. Therefore, a literature review was conducted using PubMed, CINAHL, Cochrane Library, and Scopus databases to identify educational interventions that improve adherence to medications and healthy lifestyles in osteoporotic women. The search was limited to the articles published between January 2002 and January 2015, and they were selected only if they were interventional studies. Twelve studies were included, in which 7 studies were focused on interventions to improve medication adherence, 4 studies on improving adherence to healthy lifestyles, and 1 study was focused on both. Educational interventions, such as tailored interventions with counseling sessions, were effective in improving adherence to medications and healthy lifestyles; however, educational materials such as leaflets did not improve adherence. Further studies are needed to investigate adherence to healthy lifestyles because this is poorly described in the literature.