Overcoming barriers to oral contraception in Italy an expert opinion to empower women.

Oral contraceptives are among the most commonly used contraceptive methods. However, Italian women underused reliable hormonal contraceptives as compared with other European women. There is a need to streamline access to oral contraception, with expected benefits on emotional well-being of women and potential savings for health system in Italy. Indeed, women can only access to oral contraceptives through mandatory medical prescription. This is one of the most important barrier experienced by women. We hereby provide an expert opinion on the potential reclassification, extending pharmacy services to include responsible and appropriate use of POP, as an opportunity also in Italy to increase the use of safe and effective contraceptive methods.

Bone health in menopausal women: a role for General Practitioners.

General Practitioners (GPs) are in a prime location to assess patient health needs, knowing clinical history, living habits and risk factors. GPs can identify in healthy people those in which prevention could be useful, in order to avoid or delay some diseases. For this purpose GPs need to change their care model from a waiting model to a proactive model, in order to identify health needs before the development of diseases.

Generic brands in the prevention of fragility fractures.

Generic drugs are safe and effective, but their prescription in Italy is among the lowest in Europe (30% to 60-70% in other Countries). According to a recently published retrospective study, generics are not statistically different from their corresponding brand counterpart in the therapy of osteoporosis, a bone defects characterized by a decrease in bone mineral density, which can lead to an increased frailty and risk of fracture. Unfortunately there are a lot of problems in compliance with these drugs: it is only about 7.19% in the first year, despite their consumption is simple and effective in the prevention of fracture. Various studies made by GPs are highlighting many barriers in the path from the contact with the doctor to the purchase at the pharmacy: the idea GPs have of generics, the patients' perception of it, the big amount of drugs in the pharmacies and the advice that comes from the pharmacist. The published study, proving non-inferiority of generics and lack of differences in mortality and access to specialists among those using generic and brand drugs, encourages to use those drugs that not only are safe and effective, but that are also good for the economical and financial balance of Italian sanitary system.

General Practitioner and FRAX(®) (computer-based algorithm).

Osteoporotic fractures became the most important cause of disability and an increasing burden to the public health costs in Italy and in many regions of the world. Health professionals play a central role in identifying people at high risk of osteoporosis and osteoporotic fractures. However it is important to have available methods that allow to identify patients showing high risk of fragility fractures, with lower costs and high sensitivity than those currently adopted, e.g. Dual Energy X-ray Absorptiometry (DEXA). The computer-based algorithm (FRAX®) developed by WHO shows some barriers in primary care, for instance the difficulty to access this tool by General Practitioners (since it is not available in their DATABASE). Moreover, since the incidence of fracture and the prevalence of associated risk factors change over time, risk prediction algorithms need to be dynamic, so that they can be remodelled over time. In Italy, the Health Search - CSD Longitudinal Patients Database (HSD) could potentially provide the data needed to support the development and validation of an applicable prediction tool in primary care. In this framework we aim to develop and validate a prognostic score for osteoporotic fractures in Italian General Practice and to establish a risk map.

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.

Culture, religion and gender: considerations in facing migration related health inequalities in Italy.

BACKGROUND: The presence in Italy of a significant foreign population (5-6 million including both formally residents and not officially registered ones) introduces significant transformations in the Italian demography with important challenges on ensuring fundamental rights including work, education and above all, health. Access to healthcare. Issues common to the entire migrant population concern the difficulty of accessing the health system of the host country due to the lack of knowledge of its rules and its functioning, the linguistic and cultural barriers and the distrust towards a system that is not recognized as his own, as well as the difficulties and misunderstandings encountered in the relationship with health professionals. Religion, culture and gender may even increase these difficulties. Conlusion and future perspective. Culture and religion should be taken into account when designing and implementing healthcare services and healthcare workers need to be trained in acknowledging these challenges. The National Health Service should become more sensitive to the increasing cultural and religious pluralism of patients starting with investing more in the training of health professionals.

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.

Prevalence of frailty in older people in Veneto (Italy).

Context: Both frailty and multimorbidity are strong predictors of clinical endpoints for older people. In Italy, the interventions targeting chronicity are mainly based on the treatment of diseases: sufficient epidemiological literature is available about these strategies. Less is known about the territorial distribution of the frailty status. Aims: To estimate the prevalence of frailty in older people (65+) and to evaluate the relationship between frailty and multimorbidity. Methods and material: A group of general practitioners working in Veneto (Italy) was enrolled on a voluntary basis. Older individuals were both community dwelling and institutionalized patients, that is, the older people normally followed by Italian general practitioners. A centrally randomized sample was extracted from the pool of physician-assisted elderly. Each doctor evaluated the frailty status through the CSHA Clinical Frailty Scale and the multimorbidity status through the Charlson score (Frailty = CSHA Clinical Frailty Scale's score >4; serious multimorbidity = Charlson score ≥4). Prevalence and its confidence interval (CI) 95% were evaluated through the Agresti's method for proportions. The relation between frailty and multimorbidity was studied through a logistic regression model adjusted for age and sex. Results: Fifty-three physicians were enrolled, whose population of elderly individuals (N = 82919) was highly representative of the population of Veneto. The prevalence of frailty in the randomized sample of 2407 older people was 23.18% (CI 95%: 21.53%-24.91%). Sex was shown to be a strong predictor of frailty (female status OR = 1.58 p < .0001) and multimorbidity was shown to be an independent predictor only for individuals <85 years of age. Conclusions: In Veneto, more than 20% of elderly people are frail. Physicians should pay close attention to frailty and multimorbidity because both are important prognostic factors toward clinical endpoints relevant to territorial care. The CSHA Clinical Frailty Scale (easy and quick) should become part of their professional routine.

The burden of frailty in older people visiting GPs in Veneto and Sicily, Italy.

Context: In Italy, little is known about the territorial distribution of the frailty status. Aims: To compare frailty- and multimorbidity-prevalence in the elderly population of two Italian regions. Methods: This study examined randomized samples of elderly (both community dwelling and institutionalized) assisted by general practitioners. Frailty was evaluated through the CSHA-Scale, multimorbidity through the Charlson-Score. The relation between frailty and multimorbidity was studied through a logistic model. Both crude and standardized prevalences were calculated. Results: One hundred and sixteen physicians assisted 176,503 patients highly representative of Italian people. In a randomized sample of 4,531 older people, the sex-age-standardized prevalence of Frailty (standard population: Italy) was 25.74% (24.63-26.85%). Age-standardized prevalence for males was 20.08% (18.46-21.71%) and 30.00% (28.54-31.57%) for females. Using the sex-age-standardization pooled sample, the prevalence of frailty was significantly higher in Sicily than Veneto (28.74% [27.03-30.46%] vs 22.30% [20.94-23.67%]. This study did not find differences in the prevalence of multimorbidity: Veneto 20.76% (19.21-22.31%); Sicily 22.05% (20.33-23.77%). Both "to be female" and "to live in Sicily" were shown to be predictors of frailty OR for being female = 1.64 (1.42-1.88); OR for living in Sicily = 1.27 (1.11-1.46). Multimorbidity was an independent frailty-predictor only for those aged < 85: OR of Charlson Index ≥ 4 for ages < 85 = 3.44 (2.88-4.11), OR for ages ≥ 85 = 1.44 (0.97-2.12). Limitations: (1) This study considered patients assisted by doctors, not a random sample of the general population. (2) The cross-sectional nature of the study limits the interpretation of the relationships between frailty and multi-morbidity. (3) Few covariates were available for our multivariate models. Conclusions: More than 1/4 of elderly persons are shown to be frail (1/5 of males and 1/3 of females). Frailty is more frequent in Sicily, while multimorbidity does not differ between the two regions. This could be due to regional differences in the organization of care networks dedicated to elderly patients.

Guidelines for the management of osteoporosis and fragility fractures.

The purpose of this document, a result of the harmonisation and revision of Guidelines published separately by the SIMFER, SIOMMMS/SIR, and SIOT associations, is to provide practical indications based on specific levels of evidence and various grades of recommendations, drawn from available literature, for the management of osteoporosis and for the diagnosis, prevention, and treatment of fragility fractures. These indications were discussed and formally approved by the delegates of the Italian Scientific Associations involved in the project (SIE, SIGG, SIMFER, SIMG, SIMI, SIOMMMS, SIR, and SIOT).

The care for chronic heart failure by general practitioners. Results from a clinical audit in Italy.

BACKGROUND: In Italian primary care, chronic heart failure (CHF) patients are mainly managed by general practitioners (GPs). However, there are few studies analysing CHF management challenges in primary care and identifying opportunities for improvement. OBJECTIVES: To describe CHF care as implemented by GPs in the Veneto Region and to identify opportunities for improvement. METHODS: In 2008, using an audit process, 114 Venetian GPs analysed their electronic health records, identified CHF patients and collected clinical and care related information: prevalence, co-morbidity, caring conditions, diagnostic and therapeutic management, and hospitalization. After two training sessions, data on pharmacotherapy were analysed again in 2009. RESULTS: The prevalence of CHF was 1.2% (95% CI: 1.1-1.3%). Diagnostic echocardiography was used in 57% of cases. At baseline, the proportions of patients that used specific medication were: diuretics 88%; angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB) 77%, beta-blockers 46% and anti-aldosterone agents 32%. After two training sessions, the use of ACE inhibitors/ARB and beta-blockers increased to 80% and 56%, respectively. Renal failure, chronic obstructive pulmonary disease (COPD), diabetes mellitus and dementia were the most prevalent concomitant diseases, posing specific management problems. Half of the patients were generally visited at home; they were dependent on some kind of care given. CONCLUSION: In Veneto a large number of CHF patients are mainly managed by GPs. Further improvements are necessary to meet standards of care with regard to diagnosis, medication, follow-up and home care. The care situation affected hospitalization and the quality of follow-up visits.