The Economic Burden of Biological Therapy in Rheumatoid Arthritis in Clinical Practice: Cost-Effectiveness Analysis of Sub-Cutaneous Anti-TNFα Treatment in Italian Patients:

Rheumatoid arthritis (RA), with a prevalence of 0.46%, is found in about 272,004 patients in Italy. The socioeconomic cost of rheumatoid arthritis in Italy in 2002 has been estimated at €1,600 million. Cost-effectiveness evaluations have been based on the concept that, with treatment, patients will not progress to the next level(s) of disease severity or will take a longer time to progress, thus avoiding or delaying the high costs and low utility associated with more severe disease. Many cost-effective studies have been based on the variation of Health Assessment Questionnaire (HAQ) in clinical trials. The objective of this study is to perform a cost-effective analysis of 86 patients with rheumatoid arthritis in therapy with adalimumab 40 mg every other week and etanercept 50 mg/week for two years in a population of patients observed in clinical practice. The group of patients in therapy with adalimumab had also taken methotrexate, mean dose 12.4±2.5 mg/week (22 patients) or leflunomide 20 mg/day (16 patients). The group of patients in therapy with etanercept had also taken methotrexate, mean dose 11.7±2.6 mg/week (24 patients) or leflunomide 20 mg/day (24 patients). Incremental costs and QALYs (quality adjusted life years) gains are calculated compared with baseline, assuming that without biologic treatment patients would remain at the baseline level through the year. Conversion HAQ scores to utility were based on the Bansback algorithm. The results after two years showed: in the group methotrexate+adalimumab the QALY gained was 0.62±0.15 with a treatment cost of €26,517.62 and a QALY/cost of €42,521.13. In the group methotrexate+etanercept the QALY gained was 0.64±0.26 with a treatment cost of €25,020.96 and a QALY/cost of €39,171.76. The result of using etanercept in association with methotrexate is cost-effectiveness with a QALY gained under the acceptable threshold of €50,000. These are important data for discussion from an economic point of view when we choose a biologic therapy for rheumatoid arthritis in clinical practice

Predictors of Mortality in Patients with COPD and Chronic Respiratory Failure: The Quality-of-Life Evaluation and Survival Study (QuESS): A Three-Year Study.

Previous studies sought to identify survival or outcome predictors in patients with COPD and chronic respiratory failure, but their findings are inconsistent. We identified mortality-associated factors in a prospective study in 21 centers in 7 countries. Follow-up data were available in 221 patients on home mechanical ventilation and/or long-term oxygen therapy.diagnosis, co-morbidities, medication, oxygen therapy, mechanical ventilation, pulmonary function, arterial blood gases, exercise performance were recorded. Health status was assessed using the COPD-specific SGRQ and the respiratory-failure-specific MRF26 questionnaires. Date and cause of death were recorded in those who died. Overall mortality was 19.5%. The commonest causes of death were related to the underlying respiratory diseases. At baseline, patients who subsequently died were older than survivors (p = 0.03), had a lower forced vital capacity (p = 0.03), a higher use of oxygen at rest (p = 0.003) and a worse health status (SGRQ and MRF26, both p = 0.02). Longitudinal analyses over a follow-up period of 3 years showed higher median survival times in patients with use of oxygen at rest less than 1.75 l/min and with a better health status. In contrast, an increase from baseline levels of 1 liter in O2 flow at rest, 1 unit in SGRQ or MRF26, or 1 year increase in age resulted in an increase of mortality of 68%, 2.4%, 1.3%, and 6%, respectively. In conclusion, the need for oxygen at rest, and health status assessment seems to be the strongest predictors of mortality in COPD patients with chronic respiratory failure

Responsiveness of the Oswestry Disability Index and the Roland Morris Disability Questionnaire in Italian subjects with sub-acute and chronic low back pain

Introduction An ability to assess longitudinal changes in health status is crucial for the outcome measures used in treatment efficacy trials. The aim of this study was to verify the responsiveness of the Italian versions of the Oswestry Disability Index (ODI) and the Roland Morris Disability Questionnaire (RMDQ) in subjects with subacute or chronic low back pain (LBP). Material and methods At the beginning and end of an 8 week rehabilitation programme, 179 patients completed a booklet containing the ODI, the RMDQ, a 0-10 numerical rating scale (NRS), and the 36-item Short-Form Health Survey (SF-36). A global perception of change scale was also completed at the end of the programme, and collapsed to produce a dichotomous outcome (i.e. improved vs. not improved). Responsiveness was assessed by means of distribution methods [minimum detectable change (MDC); effect size (ES); standardised response mean (SRM)] and anchorbased methods (ROC curves). Results The MDC for the ODI and RMDQ was, respectively, 13.67 and 4.87; the ESwas 0.53 and 0.68; and the SRM was 0.80 and 0.81. ROC analysis revealed an area under the curve of 0.71 for the ODI and 0.64 for the RMDQ, thus indicating discriminating capacity; the best cut-off point for the dichotomous outcome was 9.5 for the ODI (sensitivity 76% and specificity 63%) and 2.5 for the RMDQ (sensitivity 62% and specificity 55%). These estimates were comparable between the subacute and chronic subjects. Both the ODI and the RMDQ moderately correlated with the SF-36 and NRS (Spearman's and Pearson's correlation coefficients of>0.30). Conclusion The Italian ODI and RMDQ proved to be sensitive in detecting clinical changes after conservative treatment for subacute and chronic LBP.Our findings are consistentwith those published in the literature, thus allowing cross-cultural comparisons and stimulating cross-national studies. © 2011 Springer-Verlag

Can influence anxiety and depression the six-minute walking test performance in post-surgical heart valve patients? A pilot study

Various functional indicators are utilized to measure outcome in cardiac rehabilitation. Little information exists regarding the role played by psychological variables during the rehabilitative period, after cardiac valve surgery. The present study aims at exploring the relationship existing between different levels of functional capacity measured by six-minute walking test, (6MWT) and emotional aspects such as anxiety and depression. Materials and methods. 126 post-surgical heart valve patients underwent at the beginning and at the end of the rehabilitative programme: 1) 6MWT; 2) assessment of anxiety and depression (A-D Questionnaire according to the CBA-2.0 Primary Scale). Results. Cardiac rehabilitation was associated with a general and significant improvement in the 6MWT (273+98 metres versus 363+96; p<0.001) and the functional performance parameters (diastolic blood pressure; p<0.001 and fatigue p<0.001). Simultaneously there was a significant improvement of patient-reported quality of life, revealed by the A-D questionnaire in both male and female patients. The Depression Questionnaire score is predictive of functional capacity. It was demonstrated that no matter what the clinical condition of the patient, the depression score influences the patient’s performance during the 6MWT, not only regards the distance covered (p=.008), but also fatigue expressed by the Borg RPE index (p=.044). Conclusion. Depression, an emotional variable, selfevaluated by the standardized questionnaire can, even if only partially, influence the 6MWT, a functional indicator of exercise tolerance, widely utilized in cardiac rehabilitation

Galacto-Oligosaccharide/Polidextrose Enriched Formula Protects against Respiratory Infections in Infants at High Risk of Atopy: A Randomized Clinical Trial

Early nutrition affects the risk of atopy and infections through modifications of intestinal microbiota. The Prebiotics in the Prevention of Atopy (PIPA) study was a 24-month randomised, double-blind, placebo-controlled trial. It aimed to evaluate the effects of a galacto-oligosaccharide/polydextrose (GOS/PDX)-formula (PF) on atopic dermatitis (AD) and common infections in infants who were born to atopic parents and to investigate the relationship among early nutrition, gut microbiota and clinical outcomes

Prion-related peripheral neuropathy in sporadic Creutzfeldt-Jakob disease

OBJECTIVE: To assess whether the involvement of the peripheral nervous system (PNS) belongs to the phenotypic spectrum of sporadic Creutzfeldt-Jakob disease (sCJD). METHODS: We examined medical records of 117 sCJDVV2 (ataxic type), 65 sCJDMV2K (kuru-plaque type) and 121 sCJDMM(V)1 (myoclonic type) subjects for clinical symptoms, objective signs and neurophysiological data. We reviewed two diagnostic nerve biopsies and looked for abnormal prion protein (PrP(Sc)) by western blotting and real-time quaking-induced conversion (RT-QuIC) in postmortem PNS samples from 14 subjects. RESULTS: Seventy-five (41.2%) VV2-MV2K patients, but only 11 (9.1%) MM(V)1, had symptoms or signs suggestive of PNS involvement occurring at onset in 18 cases (17 VV2-MV2K, 9.3%; and 1 MM(V)1, 0.8%) and isolated in 6. Nerve biopsy showed a mixed predominantly axonal and demyelinating neuropathy in two sCJDMV2K. Electromyography showed signs of neuropathy in half of the examined VV2-MV2K patients. Prion RT-QuIC was positive in all CJD PNS samples, whereas western blotting detected PrP(Sc) in the sciatic nerve in one VV2 and one MV2K. CONCLUSIONS: Peripheral neuropathy, likely related to PrP(Sc) deposition, belongs to the phenotypic spectrum of sCJDMV2K and VV2 and may mark the clinical onset. The significantly lower prevalence of PNS involvement in typical sCJDMM(V)1 suggests that the PNS tropism of sCJD prions is strain dependent

Impiego degli Inibitori della Pompa protonica (IPP) in Piemonte: indagine sulle abitudini prescrittive dei Medici di Medicina Generale

Proton Pump Inhibitors (PPIs) (Omeprazole, Lansoprazole, Pantoprazole, Rabeprazole and Esomeprazole), one of the most commonly prescribed classes of medications in the primary care setting, are considered a major advance in the treatment of acid-peptic diseases. In Italy PPIs are reimbursed by National Health Service on the basis of CUF (Commissione Unica del Farmaco) 1 and 48 Notes. In 2002 and 2003 a significant increase in PPIs consumption and expenditure have been documented, showing differences between regions. The aim of this study is to investigate and monitor, at regional level, type and entity of PPIs use through a drug utilization study, evaluating prescribing behaviour and compliance of PPIs treatments with CUF Notes indications. The study has been carried out on a sample of 436 General Practitioners belonging to 22 Piemonte's ASL (Aziende Sanitarie Locali). The data analysis shows that acid-related pathologies are significantly more common in patients with at least 50 years of age and the most frequent condition is represented by gastroesophageal reflux disease. Despite the general conditions of PPIs use by General Practitioners in terms of duration and dosage of therapy result in most cases (from 49% to 80% for duration and from 54% to 97% for dosage) compliant with what proposed by CUF Notes, in some cases the same CUF Notes indications seem to be not observed. Consequently the Piemonte Region has decided to plan a guideline on PPIs rational use. Such guideline, expected to be introduced in the regional area, may also be considered as an instrument able to lead to a more appropriate expenditure for this drug class. Moreover, in order to control PPIs expenditure, pharmacoeconomic methodologies can be applied allowing to identify the most cost - effective active substance and therapeutic scheme, overcoming CUF Notes which consider all PPIs use under the same reimbursement conditions

Hand rehabilitation with sonification techniques in the subacute stage of stroke

After a stroke event, most survivors suffer from arm paresis, poor motor control and other disabilities that make activities of daily living difficult, severely affecting quality of life and personal independence. This randomized controlled trial aimed at evaluating the efficacy of a music-based sonification approach on upper limbs motor functions, quality of life and pain perceived during rehabilitation. The study involved 65 subacute stroke individuals during inpatient rehabilitation allocated into 2 groups which underwent usual care dayweek) respectively of standard upper extremity motor rehabilitation or upper extremity treatment with sonification techniques. The Fugl-Meyer Upper Extremity Scale, Box and Block Test and the Modified Ashworth Scale were used to perform motor assessment and the McGill Quality of Life-it and the Numerical Pain Rating Scale to assess quality of life and pain. The assessment was performed at baseline, after 2weeks, at the end of treatment and at follow-up (1month after the end of treatment). Total scores of the Fugl-Meyer Upper Extremity Scale (primary outcome measure) and hand and wrist sub scores, manual dexterity scores of the affected and unaffected limb in the Box and Block Test, pain scores of the Numerical Pain Rating Scale (secondary outcomes measures) significantly improved in the sonification group compared to the standard of care group (time*group interaction&lt;0.05). Our findings suggest that music-based sonification sessions can be considered an effective standardized intervention for the upper limb in subacute stroke rehabilitation