Cost-effectiveness of buffered soluble alendronate 70 mg effervescent tablet for the treatment of postmenopausal women with osteoporosis in Italy.

The use of buffered soluble alendronate 70 mg effervescent tablet, a convenient dosing regimen for bisphosphonate therapy, seems a cost-effective strategy compared with relevant alternative treatments for postmenopausal women with osteoporosis aged 60 years and over in Italy. INTRODUCTION: To assess the cost-effectiveness of buffered soluble alendronate (ALN) 70 mg effervescent tablet compared with relevant alternative treatments for postmenopausal osteoporotic women in Italy. METHODS: A previously validated Markov microsimulation model was adjusted to the Italian healthcare setting to estimate the lifetime costs (expressed in €2019) per quality-adjusted life-years (QALY) of buffered soluble ALN compared with generic ALN, denosumab, zoledronic acid and no treatment. Pooled efficacy data derived from the NICE network meta-analysis were used for bisphosphonate treatments. Two treatment duration scenarios were assessed: 1 year using persistence data derived from an Italian prospective observational study including 144 and 216 postmenopausal osteoporotic women on buffered soluble ALN and oral ALN, respectively, and 3 years. Analyses were conducted for women 60-80 years of age with a bone mineral density T-score ≤ - 3.0 or with existing vertebral fractures. RESULTS: In all simulated populations, buffered soluble ALN was dominant (more QALYs, lower costs) compared to denosumab. The cost per QALY gained of buffered soluble ALN compared to generic ALN and no treatment always falls below €20,000 per QALY gained. In the 1-year treatment scenario, zoledronic acid was associated with more QALY than buffered soluble ALN but the cost per QALY gained of zoledronic acid compared with buffered soluble ALN was always higher than €70,000, while buffered soluble ALN was dominant in the 3-year treatment scenario. CONCLUSION: This study suggests that buffered soluble ALN represents a cost-effective strategy compared with relevant alternative treatments for postmenopausal osteoporosis women in Italy aged 60 years and over.

Determinants, consequences and potential solutions to poor adherence to anti-osteoporosis treatment: results of an expert group meeting organized by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the International Osteoporosis Foundation (IOF).

Many patients at increased risk of fractures do not take their medication appropriately, resulting in a substantial decrease in the benefits of drug therapy. Improving medication adherence is urgently needed but remains laborious, given the numerous and multidimensional reasons for non-adherence, suggesting the need for measurement-guided, multifactorial and individualized solutions. INTRODUCTION: Poor adherence to medications is a major challenge in the treatment of osteoporosis. This paper aimed to provide an overview of the consequences, determinants and potential solutions to poor adherence and persistence to osteoporosis medication. METHODS: A working group was organized by the European Society on Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal diseases (ESCEO) to review consequences, determinants and potential solutions to adherence and to make recommendations for practice and further research. A systematic literature review and a face-to-face experts meeting were undertaken. RESULTS: Medication non-adherence is associated with increased risk of fractures, leading to a substantial decrease in the clinical and economic benefits of drug therapy. Reasons for non-adherence are numerous and multidimensional for each patient, depending on the interplay of multiple factors, suggesting the need for multifactorial and individualized solutions. Few interventions have been shown to improve adherence or persistence to osteoporosis treatment. Promising actions include patient education with counselling, adherence monitoring with feedback and dose simplification including flexible dosing regimen. Recommendations for practice and further research were also provided. To adequately manage adherence, it is important to (1) understand the problem (initiation, implementation and/or persistence), (2) to measure adherence and (3) to identify the reason of non-adherence and fix it. CONCLUSION: These recommendations are intended for clinicians to manage adherence of their patients and to researchers and policy makers to design, facilitate and appropriately use adherence interventions.

Cine 4DCT imaging artifacts: Quantification and correlations with scanning parameters and target kinetics.

To study temporal resolved computed tomography imaging (4-Dimensional Computed Tomography: 4DCT) artifacts correlations with scanning parameters and target kinetics and to assess uncertainty introduced by 4DCT in radiotherapy treatment planning. In this work we classified 4DCT artifacts as finite gantry rotation speed related (FGS) and finite sampling frequency related (FSF). We studied FGS artifacts using a respiratory phantom and FSF artifacts using a Monte Carlo simulation of acquisition timing. From our analysis FGS localization error is comparable with image resolution determined by voxel dimensions. Remaining FGS artifacts are correlated with gantry rotation time (Trot), target velocity (v) and their interaction. FSF artifacts occurrence is correlated with sampling ratio (SR), i.e. the ratio of patient respiratory period (Tresp) and sampling time (Ts). In the studied velocity range (0-2 cm/s), using a Trot of 0,5s and a SR higher than 15, FGS and FSF artifacts became comparable with other sources of uncertainty. Our considerations are valid for "ideal" breathing pattern only. When variations from periodical breathing, high target velocity (more than 2 cm/s) or high peak to peak amplitude (more than 2 cm) are present, patient specific images artifacts analysis is recommended.

A global call to action to improve the care of people with fragility fractures.

The ageing of society is driving an enormous increase in fragility fracture incidence and imposing a massive burden on patients, their families, health systems and societies globally. Disrupting the status quo has therefore become an obligation and a necessity. Initiated by the Fragility Fracture Network (FFN) at a "Presidents' Roundtable" during the 5th FFN Global Congress in 2016 several leading organisations agreed that a global multidisciplinary and multiprofessional collaboration, resulting in a Global Call to Action (CtA), would be the right step forward to improve the care of people presenting with fragility fractures. So far global and regional organisations in geriatrics/internal medicine, orthopaedics, osteoporosis/metabolic bone disease, rehabilitation and rheumatology were contacted as well as national organisations in five highly populated countries (Brazil, China, India, Japan and the United States), resulting in 81societies endorsing the CtA. We call for implementation of a systematic approach to fragility fracture care with the goal of restoring function and preventing subsequent fractures without further delay. There is an urgent need to improve: To address this fragility fracture crisis, the undersigned organisations pledge to intensify their efforts to improve the current management of all fragility fractures, prevent subsequent fractures, and strive to restore functional abilities and quality of life.

Status of Geriatrics in 22 Countries.

OBJECTIVES: The aim of this article is to describe the current status of geriatrics and position of geriatricians in 22 countries of three continents, and to portray their attitudes towards and resources allocated to geriatrics. METHODS: An electronic survey was delivered to a convenience sample of 22 geriatricians in leading positions of their countries. RESULTS: The time required in post graduation specialist training to become a geriatrician varied from one year (subspecialty in the USA) to six years (independent specialty in Belgium). The number in the population aged 80+ per geriatrician varied from 450 (Austria) to 25,000 (Turkey). Of respondents, 55% reported that geriatrics is not a popular specialty in their country. Acute geriatric wards, rehabilitation and outpatient clinics were the most common working places for geriatricians. Nearly half of the respondents had an opinion that older patients who were acutely ill, were receiving subacute rehabilitation or had dementia should be cared for by geriatricians whereas half of the respondents would place geriatricians also in charge of nursing home and orthogeriatric patients. The biggest problems affecting older people's clinical care in their countries were: lack of geriatric knowledge, lack of geriatricians, and attitudes towards older people. Half of respondents thought that older people's health promotion and comprehensive geriatric assessment were not well implemented in their countries, although a majority felt that they could promote good geriatric care in their present position as a geriatrician. CONCLUSION: The position of geriatric, geriatricians' training and contents of work has wide international variety.

Performance of the Multidimensional Geriatric Assessment and Multidimensional Prognostic Index in predicting negative outcomes in older adults with cancer.

The Multidimensional Geriatric Assessment (MGA) is currently used for assessing geriatric oncological patients, but a new prognostic index - the Multidimensional Prognostic Index (MPI) - has a demonstrated prognostic value in cancer patients too. The present work was designed to compare the MPI and MGA as predictors of 12-month mortality. 160 patients ≥70 years old with locally-advanced or metastatic solid cancers consecutively joining our Geriatric Oncology Program were administered a Comprehensive Geriatric Assessment to calculate their MGA and MPI scores. SETTINGS: Geriatric Clinic, Geriatric Surgery Clinic, Medical Oncology Unit, Padova Hospital, Italy. Using Cohen's Kappa coefficient, there was a poor concordance between the MPI and MGA. Severe MPI being associated with a higher mortality risk than Frail in the MGA. The ROC curves indicated that the MPI had a greater discriminatory power for 12-month mortality than the MGA. In our population of elderly cancer patients, the MPI performed better than the MGA in predicting mortality. Further evidence from larger prospective trials is needed to establish whether other geriatric scales, such as the GDS and CIRS-SI, could enhance the value of prognostic indexes applied to elderly cancer patients.

The METABOLIC Study: multidimensional assessment of health and functional status in older patients with type 2 diabetes taking oral antidiabetic treatment.

AIM: The objective of the METABOLIC Study was to evaluate overall health status, with particular focus on assessment of functional status of older patients taking oral antidiabetic drug (OAD) treatment. METHODS: The study included 1342 type 2 diabetes patients aged ≥ 65 years treated with OADs, with or without insulin, who had been referred to outpatients clinics across Italy. Information on diabetes (duration, medications taken during the last 3 months, hypoglycaemic events and diabetic complications) was collected by questionnaire, and the patients' overall health status was assessed using a multidimensional prognostic index. RESULTS: The sample recruited (mean age: 73.3 ± 5.5 years) had a mean duration of diabetes of 11.3 ± 8.2 years. Half were taking sulphonylureas alone or together with other medications, 9.7% were taking insulin in combination with other OADs, almost 30% were using biguanides and 6.2% were taking dipeptidyl peptidase-4 (DPP-4) inhibitors. Also, 12% of patients reported hypoglycaemic events, 90% of whom were taking insulin or sulphonylureas. In addition, 81% of the participants were completely independent in their activities of daily living, while 19% were mildly, moderately or severely disabled. Age, female gender, hypoglycaemic events, neuropathy and low diastolic blood pressure were the main variables associated with disability. CONCLUSION: Disability is common in older diabetic patients and some associated factors, such as hypoglycaemia and low diastolic blood pressure, have been identified. Also identified was malnutrition as a specific factor associated with hypoglycaemic events independent of the use of insulin and sulphonylureas.

The assessment of vertebral fractures in elderly women with recent hip fractures: the BREAK Study.

UNLABELLED: This study aimed to evaluate the prevalence of vertebral fractures in elderly women with a recent hip fracture. The burden of vertebral fractures expressed by the Spinal Deformity Index (SDI) is more strictly associated with the trochanteric than the cervical localization of hip fracture and may influence short-term functional outcomes. INTRODUCTION: This study aimed to determine the prevalence and severity of vertebral fractures in elderly women with recent hip fracture and to assess whether the burden of vertebral fractures may be differently associated with trochanteric hip fractures with respect to cervical hip fractures. METHODS: We studied 689 Italian women aged 60 years or over with a recent low trauma hip fracture and for whom an adequate X-ray evaluation of spine was available. All radiographs were examined centrally for the presence of any vertebral deformities and radiological morphometry was performed. The SDI, which integrates both the number and the severity of fractures, was also calculated. RESULTS: Prevalent vertebral fractures were present in 55.7% of subjects and 95 women (13.7%) had at least one severe fracture. The women with trochanteric hip fracture showed higher SDI and higher prevalence of diabetes with respect to those with cervical hip fracture, p=0.017 and p=0.001, respectively. SDI, surgical menopause, family history of fragility fracture, and type2 diabetes mellitus were independently associated with the risk of trochanteric hip fracture. Moreover, a higher SDI was associated with a higher percentage of post-surgery complications (p=0.05) and slower recovery (p<0.05). CONCLUSIONS: Our study suggests that the burden of prevalent vertebral fractures is more strictly associated with the trochanteric than the cervical localisation of hip fracture and that elevated values of SDI negatively influence short term functional outcomes in women with hip fracture.

Evaluation of health outcomes in elderly patients with asthma and COPD using disease-specific and generic instruments: the Salute Respiratoria nell'Anziano (Sa.R.A.) Study.

OBJECTIVES: To compare the effects of asthma and COPD on health status (HS) in elderly patients, and to assess the correlation between disease-specific and generic instruments assessing HS. DESIGN: Multicenter, cross-sectional, observational study. SETTING: The Salute Respiratoria nell'Anziano (respiratory health in the elderly) Study network of outpatient departments. PATIENTS: One hundred ninety-eight asthma patients and 230 COPD patients > or = 65 years old. MEASUREMENTS: HS was assessed by the Saint George's Respiratory Questionnaire (SGRQ) and five generic outcomes: Barthel's index, 6-min walk test, mini mental state examination, geriatric depression scale (GDS), and quality-of-sleep index. Independent correlates of SGRQ scores were assessed by logistic regression. Patients were considered to have a "good" HS or "poor" HS according to whether they did or did not perform worse than 75% of the corresponding population of asthma or COPD patients, on at least two of the five generic outcomes. RESULTS: On average, COPD patients had poorer HS than asthma patients on the SGRQ. Only polypharmacy (more than three respiratory drugs) and diagnosis of COPD qualified as independent correlates of the SGRQ score. The SGRQ "Activity" and "Impacts" scores shared the following independent correlates: polypharmacy, Barthel's index < 92, and GDS > 6. Further correlates were waist/hip ratio > 1 for the Activity score, and age and occiput-wall distance > 9 cm for the Impacts score. All sections of the SGRQ except for the Symptoms score could significantly distinguish patients with good HS and poor HS. CONCLUSIONS: Individual dimensions of HS recognize different determinants. COPD outweighs asthma as a cause of distressing respiratory symptoms. A high degree of concordance exists between SGRQ and generic health outcomes, except for the Symptoms dimension in COPD patients.

Prevalence rate of urinary incontinence in community-dwelling elderly individuals: the Veneto study.

BACKGROUND: Urinary incontinence (UI) is a common problem in elderly people, due mainly to functional impairments and concurrent medical diseases. Few studies, however, have assessed the prevalence of UI in noninstitutionalized individuals. The objectives of the present work were to estimate the prevalence of UI in a community-based population of elderly Italians and to determine the associated physical, social, and psychological factors. METHODS: A random sample of noninstitutionalized men (n = 867) and women (n = 1531), aged 65 years and older, from the Veneto region of northeastern Italy, were interviewed at home, using an extensive multidisciplinary questionnaire, to assess their quality of life and social, biological, and psychological correlates. RESULTS: The prevalence rate of UI was of 11.2% among men and of 21.6% among women. Among those reporting the condition, approximately 53% of women and 59% of men reported experiencing incontinence daily or weekly. Association of UI was found for participants older than 70 years in both men (odds ratio [OR] 2.49, 95% confidence interval [CI] 1.45-4.28) and women (OR 1.49, 95% CI 1.11-2.02). Three of the medical conditions investigated were associated with increases in the odds in women, namely chronic obstructive pulmonary disease (OR 1.53, 95% CI 1.11-2.12), Parkinsonism (OR 2.27, 95% CI 1.14-4.54), and hip fracture (OR 1.38,95% CI 1.02-1.88), whereas chronic diarrhea was the only condition associated with UI in men (OR 6.92, 95% CI 2.22-21.5). Participants with a physical disability were two times more likely to report incontinence, and the odds were increased by 50% in women who had sleep disturbances. CONCLUSIONS: Incontinence is highly prevalent in the Italian elderly population, and several common chronic conditions are significantly associated with it. Moreover, very few people with incontinence seek health care or are aware of potential treatments.

Dietary intake and nutritional status in Italian elderly subjects.

Dietary intake and nutritional status was assessed in a random sample of 190 Italians (70-75 years of age) participating in the Survey in Europe on Nutrition and the Elderly (EURONUT-SENECA). The daily energy intake as assessed by a Modified Dietary History, was 2208+/-562 Kcalories in men and 1742+/-527 Kcalories in women. The alcohol intake was significantly higher in men than in women (35. 9+/-32.5 g/day vs 14.7+/-15.4 g/day; p<0.0001). As for calcium, there was a high percentage of men (77%) and women (86%) with a lower intake than the recommended values. The subjects underweight (BMI<20) were only 4.1% men and 9.7% women, while the great part was normal (BMI= 20-24.9) and overweight (BMI=25-29.9). The body composition parameters showed a significant difference between two genders. Men had a Total Body Water (56.5+/-4.5% vs 51.3+/-5.4%; p<0. 001) and Fat-Free Mass (80.4+/-5.2% vs 70.9+/-6.8%; p<0.001) higher than women. Few subjects were at high risk of deficiency with regard to plasma levels of vitamins, haemoglobin and albumin. If we analyse the composition of the diet consumed, we can remark the characteristics of a typical Mediterranean diet. We conclude that the general nutritional status of our sample was fairly good.

Original articles: ease of wound closure as an endpoint of treatment efficacy.

New treatments for chronic wounds require carefully performed clinical trials with significant endpoints. Total wound closure is the only endpoint currently accepted by the Food and Drug Administration. This study describes a scale that measures ease of wound closure and applies it to a four-arm prospectively randomized, blinded pressure ulcer trial of recombinant human platelet-derived growth factor-BB. Following validation of interrater reliability, 83 evaluable subjects' photographs were given a weekly ease of closure score by four raters blinded to treatment. The change of ease of closure score was correlated with the change of wound area and volume. Each ease of closure score was given a procedural cost. Results showed ease of closure did not directly correlate with either wound area or volume, suggesting that it was measuring additional information. The mean change in ease of closure score was 6 for subjects treated with 100 microg recombinant human platelet-derived growth factor-BB daily; 5 for those treated with 300 microg growth factor daily or 100 microg recombinant human platelet-derived growth factor-BB bid; and 4 for those treated with placebo. The cost savings ranged from $7200 for the group receiving 100 microg recombinant human platelet-derived growth factor-BB daily to $6300 for the controls. Outcomes in all 4 groups were significantly improved from their starting evaluation (p < 0.001). Based on this study, ease of closure is a verifiable endpoint that can be related to cost efficiency and may be a measure of efficacy.

[Computerized tomography of the thorax and abdomen. Cost-effectiveness]. / Tomografia Computerizzata del torace e dell'addome. Costi ed efficacia.

This work was aimed at investigating the cost-effectiveness of body CT, toward better equipment allocation in a given area. CT economics were calculated taking into account four main parameters: equipment, drugs, sanitary material and personnel. The biological cost in terms of radiation exposure was calculated on the effective dose. Quality was evaluated by comparing it with that of our standard examinations and on the basis of the diagnostic yield according to the index of radiological diagnoses by the American College of Radiology (ACR). The economic cost of chest CT was It. L. 257,240, that of abdominal CT was It. L. 365,000 and that of both regions It. L. 464,620. The effective dose was relatively high, i.e., 15.2 mSV for chest CT, 18.65 mSV in men and 27.46 mSV in women for abdominal CT and finally 27.38 mSV in men and 33.59 in women for chest-abdominal CT. The coded diagnoses were positive in approximately 60% of the cases examined consecutively; positivity was related to clinically relevant conditions in most of the cases. The economics and the biological cost of body CT exams were closely related to exam quality, whose standard was high. The high rate of positive findings and the clinical relevance of the condition make an indirect indicator of high quality and of accurate patients selection. To conclude, the allocation of CT equipment in a given area should be preceded by a careful cost-effectiveness analysis, considering optimized equipment use as related to local clinical needs.