The value of the polypill in cardiovascular disease: an Italian multidisciplinary Delphi panel consensus.

The purpose of this work was to reach the consensus of a multidisciplinary and multistakeholder Italian panel on the value of polypill in cardiovascular disease, with respect to the clinical, technological, economic and organizational dimension. A three-step modified Delphi method was used to establish consensus. Eleven experts in the area of cardiology, pharmaceutical technology, general practice, hospital pharmacy, pharmacology, and health economics participated in the expert panel. To identify existing evidence concerning the value of polypill in the prevention of patients with cardiovascular disease, a systematic literature review was carried out according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses statement guidelines. In the first round, 22 statements were distributed to the panel. Panel members were asked to mark 'agree' or 'disagree' for each statement and provide any comments. The same voting method was again used for the second round. In the first round nine statements met consensus. In the second round, 10 statements reached consensus. Overall, consensus was reached for 19 statements representing five value polypill domains: clinical, technological, economic and organizational. During a final web meeting with all panel members consensus document open points were discussed. Panel members agreed to recognize polypill as effective in reducing cardiovascular events, blood pressure and lipids, cardiovascular risk and the weight of therapy, in therapeutic adherence improvement, in the absence of differences in bioavailability between drugs administered in fixed or free combinations and the better cost-effectiveness profile compared with standard care. This document represents a knowledge framework to inform decision makers of the value of polypill in cardiovascular prevention.

Quality of Life and Burden of Disease in Italian Patients with Transfusion-Dependent Beta-Thalassemia.

Lifespan treatment in transfusion-dependent ß-thalassemia (TDT) is expected to impact quality of life. This study aimed at evaluating health-related quality of life (HRQoL), well-being, and the burden of TDT on Italian patients. Patients (≥14 years) were invited to complete a cross-sectional, online volunteer survey. HRQoL was measured by the 36-item short-form health survey (SF-36) and wellbeing was measured by the Italian version of the Psychological General-Well-Being-Index (PGWBI). A total of 105/167 completed questionnaires were analyzed (46% males; median age 44, (IQR = 11)). Patients reported lower HRQoL compared with the general population in all SF-36 domains (except for emotional well-being (p = 0.7024) and role limitations due to emotional problems (p = 0.1389)). PGWBI domains general health and vitality and the total PGWBI score were all significantly lower (p = 0.0001) compared with the general population. On average, patients spent 16.62 h/month engaged in care activities that were additional to the time required for completing transfusions. Of the 16.62 h/month, 11.7 h/month were required for therapy management and 4.92 h/month for family management. This study found lower HRQoL and well-being in physical and psychological domains compared with the general population. Further, patients were found to have a high perceived burden of disease.

Treatments in neurogenic bowel dysfunctions: evidence reviews and clinical recommendations in adults.

INTRODUCTION: Neurogenic bowel dysfunction (NBD) is an impairment of defecation control due to any nervous system lesion negatively affecting physical health status and quality of life. We aimed at systematically assessing all available evidence on NBD treatment in adults and providing clinical management guidance and recommendations. EVIDENCE ACQUISITION: PICOs and questions (N.=7) were identified by an expert panel. We searched for and retrieved evidence from the PUBMED and EMBASE databases, limited to the English language and the Western countries context, related to any type of setting and published from 2009 to 2019. Health effects, patient values, preferences and resource use were assessed. Of all, only RCTs, observational studies and systematic reviews on adult population (≥18 years) were analyzed. The study was conducted according to PRISMA guidelines and Cochrane recommendations. The effect size, if possible, was calculated for the interpretation of the outcomes, and evidence was assessed through the GRADE method. EVIDENCE SYNTHESIS: Thirty-one studies were included in our qualitative synthesis. Evidence is generally scarce. Most of the outcomes are narratively described and therefore defined by imprecision. Besides, most of the included studies are affected by risk of bias. Digital stimulation was found to be effective in short term follow-up. The pharmacological treatment choice, combined or alone, needs to be balanced case by case considering clinical history, setting of use and bowel management protocol. According to only one RCT supporting evidence mainly in persons affected by spinal cord injury (SCI), trans-anal irrigation (TAI) improves QoL and patient independency with a significant reduction of time spent for defecation and daily bowel program. History of urinary infections predicts the choice of using TAI. Patient-reported efficacy of colostomy alone or in combination with other surgeries appears evident in terms of patient's satisfaction and QoL over time. Nonetheless, perioperative and late complications can occur and may result in reduced acceptability over time. CONCLUSIONS: Evidence is somehow weak and mainly reported in SCI. The systematic use of assistive interventions does not reduce the need of conservative or invasive approaches. Studies are needed on the role of bowel management in protecting patients from complications secondary to NBD in long term follow-ups.

Agreement between chest ultrasonography and chest X-ray in patients who have undergone thoracic surgery: preliminary results.

BACKGROUND: Chest Ultrasonography (chest US) has shown good sensibility in detecting pneumothorax, pleural effusions and peripheral consolidations and it can be performed bedside. OBJECTIVES: The aim of the study was to analyze agreement between chest US and chest X-ray in patients who have undergone thoracic surgery and discuss cases of discordance. METHODS: Patients undergoing thoracic surgery were retrospectively selected. Patients underwent routinely Chest X-ray (CXR) during the first 48 h after surgery. Chest US have been routinely performed in all selected patients in the same date of CXR. Chest US operators were blind to both reports and images of CXR. Ultrasonographic findings regarding pneumothorax (PNX), subcutaneous emphysema (SCE), lung consolidations (LC), pleural effusions (PE) and hemi-diaphragm position were collected and compared to corresponding CXR findings. Inter-rater agreement between two techniques was determined by Cohen's kappa-coefficient. RESULTS: Twenty-four patients were selected. Inter-rater agreement showed a moderate magnitude for PNX (Cohen's Kappa 0.5), a slight/fair magnitude for SCE (Cohen's Kappa 0.21), a fair magnitude for PE (Cohen's Kappa 0.39), no agreement for LCs (Cohen's Kappa 0.06), high levels of agreement for position of hemi-diaphragm (Cohen's Kappa 0.7). CONCLUSION: Analysis of agreement between chest X-ray and chest US showed that ultrasonography is able to detect important findings for surgeons. Limitations and advantages have been found for both chest X-ray and chest US. Knowing the limits of each one is important to really justify and optimize the use of ionizing radiations.

Postoperative chest ultrasound findings and effectiveness after thoracic surgery: A pilot study.

The aim of this study was to analyze the information from post-operative chest ultrasound (CU) to evaluate the possibility to use this method instead of chest X-ray (CXR) after thoracic surgery. Patients who underwent thoracic surgery were evaluated with CU blinded to CXR after surgery, deciding if it was useful or CU was exhaustive. Twenty-four patients were enrolled prospectively. The CU allowed a further discrimination of the lung abnormalities, discriminating between atelectasis, infections or hematoma. CXR was required in only 5 cases due to the presence of massive subcutaneous emphysema or absence of lung point. In the remaining 19 cases, CU was considered exhaustive and effective. In particular, CU was considered exhaustive in 67% of cases after open surgery and in 85% of cases after video-assisted thoracic surgery. In conclusion, CU appears to be effective in post-operative management after thoracic surgery and it can increase the diagnostic accuracy reducing any unnecessary X-ray exposure.

The true cost of thyroid surgery determined by a micro-costing approach.

Whether the amount of the current DRG tariff for thyroid surgery covers its actual cost has been questioned. We estimated a reliable cost of thyroid surgery for a large Italian hospital. A micro-costing approach is used with data from the University Hospital "Umberto I," a large facility that conducts a high volume of thyroidectomy surgical procedures in the Lazio region. The direct costs of surgery and hospitalization for a total and a hemi-thyroidectomy were €4956 and €4673, respectively. When compared to the DRG tariff of €3340, total thyroidectomy was €1616 (48 %) more per procedure and hemi-thyroidectomy was €1333 (40 %) more per procedure. This DRG shortfall is calculated to generate an annual procedure-specific deficit of approximately €1.38 million for this hospital. Furthermore, when the costs associated with pre-surgical work-up, post-surgical follow-up, and complications management through 12 months are incorporated, the estimated costs of total and hemi-thyroidectomy rose to €5812 and €5277, respectively. The true cost of thyroid surgery in Italy is significantly higher than what has been reported in the literature or reimbursed by the DRG tariff.

A cost-consequence analysis of hepatitis B screening in an immigrant population.

OBJECTIVE: Screening for HBV among groups at risk, such as migrant populations, has proved to be a cost-effective strategy. With a view to advising local policy-makers, the cost-consequences of HBV screening was assessed using a modeling approach. METHODS: This cost-consequence analysis of an HBV screening strategy was conducted in a cohort of adult migrants in the province of Padua, northern Italy. RESULTS: The population targeted for screening consisted of 65 405 migrants, among whom the weighted rate for the prevalence of HBV was 0.04972, with 3251 people infected. Over a period of 5 years, the screening strategy prevented 565 cases/year of chronic hepatitis, 141 of compensated cirrhosis, 9 of decompensated cirrhosis, 14 hepatocellular carcinomas and 12 deaths. The above data revealed that the incremental cost of the screening strategy compared to no screening strategy was € 7 974 959 over the five year period. The cost per life saved amounted to € 676 709. CONCLUSIONS: The present study provides useful information to policy-makers at local and regional levels.

The costs of mobilisation and collection of peripheral blood stem cells in multiple myeloma and lymphoma in an European country: results from The Gruppo Italiano Trapianto Midollo Osseo (GITMO) and Società Italiana di Emaferesi e Manipolazione Cellulare (SIdEM) survey.

Scarce information is available about the cost of mobilisation/collection of peripheral blood stem cells for patients undergoing autologous transplant for relapsed Lymphoma or Multiple Myeloma. This paper reports the consumption of resources and costs collected through a survey among Italian Centres who adhere to the GITMO and SIdEM scientific societies. General transplant information was extracted from the European Promise database. Resources used alongside the phases of mobilisation/collection were retrieved. Resources for each of the process phases were quantified and averaged across centres and a unit cost value was attributed, based on administrative data from 3 centres, tariffs and market values. 25/89 Centres (34% of 2009 Promise transplants) provided data according to their standard practice. The mean cost/patient of the process of cell mobilisation/collection was € 6830 ± 1802 for Multiple Myeloma and € 7304 ± 1542 for Lymphoma. The organisational path for PBSC mobilisation/collection appears complex and cumbersome, spread amongst different treatment settings, with many different healthcare professionals being involved and considerable amounts of time and resources being currently dedicated to the management of patients requiring autologous transplantation.

Cost of laparoscopy and laparotomy in the surgical treatment of colorectal cancer.

BACKGROUND: The comparative costs of laparoscopy and laparotomy in surgical resection of colorectal cancer, especially of the hospital provider, have not yet been assessed in the perspective of the Italian National Healthcare System. This paper aims to fill this gap by providing economic information on this research topic of growing relevance at a time of reduced healthcare budgets. METHODS: Three Italian reference centres retrospectively provided from their databases data on 90 cases of laparotomy (OP) or laparoscopy (LAP) interventions for right colon (RCol), left colon/sigma (LCol) and rectum (Rec). Costs were retrieved according to phases of the in-hospital procedure: pre-operative, operative and post-operative phase, including diagnostic work-up, hospital length of stay, duration of intervention, theatre occupation time, type of anaesthesia, medical devices and drugs used and staff time throughout the management process from hospital admission to discharge. The cost estimation was carried out using a microcosting, bottom-up technique, and statistical analysis was carried out using appropriate techniques. RESULTS: The average cost of colorectal surgery was euro 10,539/patient (median euro 10,396) with rectum procedures being statistically more costly than colon procedures (mean Rec euro 12,562/patient versus LCol euro 9,054 and RCol euro 10,002; median euro 11,704 versus euro 8,941 and euro 9,513, respectively; p < 0.0001). The average cost per patient did not differ between the two procedures for colon interventions, whereas a statistically significant difference was found for rectum procedures (LAP euro 11,617 versus OP euro 13,506; median euro 11,563 versus euro 12,568; p = 0.0442). The national diagnosis related groups (DRG) tariff is insufficient to remunerate the providers' activity, irrespective of the type of disease (surgical site) and surgical technique adopted. CONCLUSION: Colorectal cancer surgery is a costly procedure, and in-patient DRG tariffs are currently insufficient to cover the cost of its management for Italian hospital providers.

Risedronate versus alendronate in older patients with osteoporosis at high risk of fracture: an Italian cost-effectiveness analysis.

BACKGROUND AND AIMS: This evaluation of the cost-effectiveness of risedronate vs generic alendronate is based on effectiveness data from a large real practice study. Applying a published cost-effectiveness model, we found that risedronate is cost-effective vs generic alendronate in an Italian population aged > or =65 years, and becomes dominant, saving costs and avoiding fractures, in patients aged > or =75 years. The aim of this work was to assess the cost-effectiveness and health utility of risedronate vs generic alendronate in clinical practice in Italy, using effectiveness data from the REAL study. METHODS: A pre-existing model of osteoporosis was used to predict numbers of fractures, quality-adjusted life-years (QALYs), and costs associated with risedronate or alendronate treatment in post-menopausal (PMO) women aged > or =65 years with a previous vertebral fracture, within the Italian National Health System (NHS). Duration of treatment with risedronate or alendronate was assumed to occur for one year and patients were followed for an additional five years to capture longterm costs and outcomes, with a discount rate of 3% for costs and outcomes. Comprehensive sensitivity analyses were run. RESULTS: The lower fracture rate among risedronate patients with respect to alendronate patients resulted in savings of euro 19,083, a reduction of 8.91 hip fractures and an associated benefit of 7.46 QALYs, in an Italian cohort of 1,000 patients. Sensitivity analyses confirmed the robustness of these results. CONCLUSIONS: This economic analysis showed that risedronate is a cost-effective treatment in a population of Italian women aged 65 years and older at high risk of PMO-related fractures. Risedronate becomes dominant over generic alendronate in patients of 75 years or older and its cost-effectiveness even appears improved in patients with BMD score < or = -3 or < or = -3.5, with/without maternal history of fractures. Risedronate should be considered as a cost-effective option vs generic alendronate, in the Italian NHS' perspective.

Cost-effectiveness of 123I-FP-CIT SPECT in the differential diagnosis of essential tremor and Parkinson's disease in Italy.

Economic evaluation (Italian NHS perspective) modeling (123)I-FP-CIT SPECT (DaTSCAN) compared to clinical judgment alone for differentiating essential tremor (ET) from Parkinson's Disease (PD). A 5-year Markov model was constructed to assess the cost-effectiveness of (123)I-FP-CIT SPECT to differentiate ET from PD in patients referred to a movement disorder specialist in Italy. Published data and a double-round, Delphi panel of 12 specialists populated the model. Effectiveness was expressed as the projected Years on potentially beneficial therapy (PBTYs). Costs were expressed in Euros (2005 values). The model suggests that over 5 years, the "current" diagnostic pathway generated an average of 2.3 PBTYs/patient at an estimated cost of 8,864 euros. (123)I-FP-CIT SPECT generated an average of 4.1 PBTYs/patient at an estimated cost of 8,422 euros, which represented an additional 1.8 PBTYs at a cost saving of 442 euros/patient (341 euros when discounted at 5%). The estimated cost-effectiveness of (123)I-FP-CIT SPECT is under 1,000 euros per PBTY gained when the underlying disease prevalence is high (55-70%), and cost-saving at prevalence under 55%. (123)I-FP-CIT SPECT is likely to be regarded as economically advantageous to differentiate ET from PD, increasing time on potentially beneficial therapy at a lower overall cost to the healthcare system.

Major complications have an impact on total annual medical cost of diabetes: results of a database analysis.

BACKGROUND: Type 2 diabetes mellitus is a common, chronic, and costly disease, and its prevalence is increasing in major industrialized countries. Diabetes has indeed a high social impact mainly because of its chronic complications. OBJECTIVE: The aim of this study was to analyze the direct medical costs attributable to Type 2 diabetes mellitus and its determinants, as assessed in a diabetologic center (DC) in Italy. METHODS: We conducted a retrospective longitudinal cost of care study; Type 2 diabetic patients who visited between January 2001 and August 2002 were randomly selected from the database of the DC of Portogruaro. Cost data collected included hospitalizations, visits, diagnostics, and pharmacological therapies and were quantified and analyzed in the perspective of the National Health Service (NHS). RESULTS: Two hundred ninety-nine diabetic patients were extracted, with a mean/patient follow up of 476 days. Mean age was 67.5 years and males represented 67.2% of the sample. The average annual health care cost was found to be euro1909.67 per patient; pharmacological therapies accounted for the greatest proportion of direct medical costs (52%), followed by hospitalization (28%) and diagnostic exams (11%). Annual costs increased with the number of diabetes related comorbidities, from euro1039 to 3141 per patient in participants with none or more than two complications, respectively. CONCLUSION: Long-term complications carry a considerable impact on total annual medical cost. Our study demonstrates that an increase in the number of comorbidities is directly associated with an increase of Type 2 diabetes cost. Strategies aimed at preventing the onset of diabetic complications are likely to reduce medical costs in the long run, while improving patients' health.

Evaluation of non-medical costs associated with visual impairment in four European countries: France, Italy, Germany and the UK.

INTRODUCTION: Visual impairment is a severe disability that puts a heavy burden on individuals, families and society. In developed countries, the two major diseases leading to irreversible visual impairment are glaucoma and age-related macular degeneration. Their prevalence will increase dramatically with population aging. The economic consequences of visual impairment are considerable, but have rarely been documented, apart from some 'top-down' estimates based on national statistics. We estimated the non-medical costs related to visual impairment in four European countries: France, Italy, Germany and the UK. METHODS: Prevalence rates of visual impairment, defined according to local regulations, were taken from national registers and, for France, from two recent nationwide surveys conducted by the French Institute for National Statistics and Economic Studies (Institut National de la Statistique et des Etudes Economiques [INSEE]). Estimates of the number of non-registered persons were obtained from the literature and expert opinion. Estimates of non-medical costs included institutional care, non-medical devices, residential adaptations, burden on carer, paid home help, loss of income and social allowances related to visual impairment. Unit costs (year 2004) were extracted from national databases and manufacturers. Healthcare professionals were interviewed to estimate the duration of assistance required by visually impaired persons. These durations were used to evaluate the cost of paid assistance at home in the four countries. RESULTS: The numbers of visually impaired persons were 1.27 million in France, 0.73 million in Germany, 1.03 million in Italy and 1.11 million in the UK, including, respectively, 56%, 11%, 80% and 72% non-registered persons. The frequency of institutionalisation for visually impaired persons were, respectively, 7.8%, 9.6%, 10.9% and 10%. Total annual costs for visually impaired persons were estimated at euro 10,749 million in France, euro 9214 million in Germany, euro 12,069 million in Italy and euro 15,180 million in the UK. This translated into average annual costs per affected individual of euro 8434, euro 12,662, euro 11,701 and euro 13,674, respectively. The main cost components of visual impairment in the community were 'loss of income' (23-43% of community costs), 'burden on carer' (24-39%) and 'paid assistance' (13-29%). CONCLUSION: Total non-medical costs associated with visual impairment are considerable. The present analysis demonstrates that the preponderant economic consequences of visual impairment lie beyond healthcare systems, and that visual impairment has a considerable negative impact on productivity. Considering the non-medical social dimensions of visual impairment related to the consequent incapacity and dependency should encourage payers to finance health innovations that aim to preserve vision.

Different aspects of adherence to antihypertensive treatments.

This review collects together data concerning the measurement of patient behavior towards antihypertensives, considering all its aspects - adherence, persistence and switching. The wide heterogeneity of terms, outcome definitions and methods of assessment (the multiplicity of approaches did not allow a full meta-analysis, but a qualitative description of the results) are demonstrated. The percentages of adherence/compliance from the studies discussed in this review range from 15 to 99% across different study designs, populations and methods. Large, observational studies are suggested as a reliable method to measure patient behavior. An emerging issue is the relevance of patient motivation and education, which could provide a higher level of compliance to treatment, thus allowing achievement of better clinical outcomes and improved use of resources for the healthcare system.

Long-term social costs of hypertension.

According to published studies, much of the cost of hypertension is due to antihypertensive drug treatment. However, the cost of hypertension also includes the cost of an increased frequency of cardiovascular events when hypertension is not controlled. Although conceptually accepted by the scientific community, the achievement of appropriate blood pressure levels is less feasible than expected and studies demonstrate that only 13-27% of hypertensive patients are adequately informed, treated and controlled for their hypertension. This puts a tremendous burden on the healthcare system and society, since uncontrolled hypertension leads to higher rates of cardiovascular events and ultimately death. This paper demonstrates the paucity of reliable cost-of-illness estimates for the long-term consequences of uncontrolled hypertension and suggests that it is understandable that public and private payers focus on the immediate short-term costs of treating hypertension, paying less attention to potential cost savings of fewer cardiovascular events, as these costs are far less well defined. This paper also suggests that hypertension as a disease is an ideal candidate for disease management strategies and programs, as prevention of its long-term consequences should be the focus of medical treatment and could be better achieved through an integrated multispecialist and multisetting approach.

The pandora project: cost of hypertension from a general practitioner database.

AIM: The Pandora Project is a longitudinal database--implemented by general practitioners since June 1997 in the Ravenna area (Italy)--providing information on patients with hypertension. Data from 1,651 patients were followed up for I year in order to investigate the cost of hypertension. Only direct medical costs were considered in the perspective of the National Healthcare System. FINDINGS: At enrollment, 552 patients were classified as normotensive, 1,099 as hypertensive. After 1 year, among normotensive group, 352 patients remained normotensive and 200 became hypertensive; among hypertensive group, 323 patients became normotensive and 776 remained hypertensive. The average total cost per patient at follow-up was 779.59 Euros. About 46% of total cost was due to anti-hypertensive therapy, irrespective of the evolution of blood pressure levels registered, whilst other direct costs represented 54% of total patient cost in all cohorts. It is possible that co-morbidities play a significant role in this situation. Patient aged 80-89 years generate higher costs. Even if further investigation is needed on the burden of comorbidity on a per-patient cost of hypertension, this work provides evidence that the average total cost per patient is likely to increase with age and co-morbidities. Key words: cost-of-illness, costs, economics, hypertension.