PubMed | Fondazione Salvatore Maugeri IRCCS and Continuity Care Unit and Telemedicine Service
Type: Journal Article | Journal: Trials | Year: 2016
Chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) frequently coexist, significantly reducing patients quality of life and increasing morbidity and mortality. For either single disease, a multidisciplinary disease-management approach supported by telecommunication technologies offers the best outcome in terms of prolonged survival and reduced hospital readmissions. However, no data exist in patients with combined COPD/CHF. We planned a randomized controlled trial to investigate the feasibility and efficacy of an integrated, home-based, medical/nursing intervention plus a rehabilitation program versus conventional care in patients with coexisting COPD/CHF. The purpose of the paper is to describe the rationale and design of the trial.Patients, after inpatient rehabilitation, were randomly assigned to the intervention or control group, followed for 4months at home, then assessed at 4 and 6months. The intervention group followed a telesurveillance (telephone contacts by nurse and remote monitoring of cardiorespiratory parameters) and home-based rehabilitation program (at least three sessions/week of mini-ergometer exercises, callisthenic exercises and twice weekly pedometer-driven walking, plus telephone contacts by a physiotherapist). Telephone follow-up served to verify compliance to therapy, maintain exercise motivation, educate for early recognition of signs/symptoms, and verify the skills acquired. At baseline and 4 and 6months, the 6-min Walk Test, dyspnea and fatigue at rest, oxygenation (PaOCurrently, no studies have assessed the impact of a telehealth program in patients with combined COPD and CHF. Our study will show whether this approach is effective in the management of such complex, frail patients who are at very high risk of exacerbations.Network per la prevenzione e la sanit pubblica, CCM, Ministero della Salute Modelli innovativi di gestione integrata telegestita ospedale-territorio del malato cronico a fenotipo complesso: studio di implementazione, validazione e impatto, registered on 14 January 2014. ClinicalTrials.gov Identifier: NCT02269618 , registered on 17 October 2014.
PubMed | Hospital Universitario San Cecilio, National Research Institute, University of Oslo, Fondazione Salvatore Maugeri IRCCS and 3 more.
Type: | Journal: Journal of human hypertension | Year: 2016
The DISTINCT study (reDefining Intervention with Studies Testing Innovative Nifedipine GITS-Candesartan Therapy) investigated the efficacy and safety of nifedipine GITS/candesartan cilexetil combinations vs respective monotherapies and placebo in patients with hypertension. This descriptive sub-analysis examined blood pressure (BP)-lowering effects in high-risk participants, including those with renal impairment (estimated glomerular filtration rate<90mlmin
Guerriero F.,Instituto Of Cura Santa Margherita |
Sgarlata C.,University of Pavia |
Marcassa C.,Fondazione Salvatore Maugeri IRCCS |
Ricevuti G.,Instituto Of Cura Santa Margherita |
Rollone M.,Instituto Of Cura Santa Margherita
Clinical interventions in aging | Year: 2015
PURPOSE: Chronic pain is highly prevalent in older adults. Increasing evidence indicates strong opioids as a valid option for chronic pain management in geriatrics. The aim of this study was to evaluate efficacy and safety of low-dose oral prolonged-release oxycodone-naloxone (OXN-PR) in patients aged ≥70 years.METHODS: This open-label prospective study assessed older patients naïve to strong opioids presenting with moderate-to-severe chronic pain. Patients were prescribed OXN-PR at an initial dose of 10/5 mg/day for 28 days. In case of insufficient analgesia, the initial daily dose could be increased gradually. The primary efficacy measure was change in pain intensity from baseline, assessed by a ten-point Numeric Rating Scale (NRS) at day 28 (T28). Changes in cognitive state, daily functioning, quality of life, constipation, and other adverse events were assessed.RESULTS: Of 53 patients enrolled (mean 81.7±6.2 years [range 70-92 years]), 52 (98.1%) completed the 28-day observation. At T28, the primary end point (≥30% reduction in mean pain from baseline in the absence of bowel function deterioration) was achieved in 38 patients (71.7%). OXN-PR significantly relieved pain (NRS score -3.26; P<0.0001), as well as daily need for rescue paracetamol (from 86.8% at baseline to 40.4% at T28; P<0.001), and reduced impact of pain on daily activities (Brief Pain Inventory Short Form from 6.2±1.5 to 3.4±2.1; P<0.0001). OXN-PR was also associated with significant improvement in daily functioning (Barthel Index from 53.3±14.1 to 61.3±14.3; P<0.01). No changes were observed in cognitive status and bowel function. OXN-PR was well tolerated; only one patient (1.9%) prematurely withdrew from treatment, due to drowsiness.CONCLUSION: Findings from this open-label prospective study suggest that low-dose OXN-PR may be effective and well tolerated for treatment of moderate-to-severe chronic pain in older patients. Besides its effectiveness, these data indicate that low-dose OXN-PR may be considered a safe analgesic option in this fragile population and warrants further investigation in randomized controlled studies.
PubMed | University Utrecht, Fondazione Salvatore Maugeri IRCCS, University of Sheffield, Charité - Medical University of Berlin and 5 more.
Type: Journal Article | Journal: Amyotrophic lateral sclerosis & frontotemporal degeneration | Year: 2016
Management of ALS is suboptimal. Consequently, quality improvement interventions are needed to improve ALS care. An evidence-based insight into how patients should be managed is essential when developing quality improvement interventions. Therefore, this study aimed to map, categorize and summarize international guidance on the management and care of ALS and to identify gaps in this guidance by means of a mapping review. Literature was searched for clinical practice guidelines, quality indicators and evidence-based clinical summaries. A content analysis and meta-synthesis of the included literature was performed. Interventions and outcomes used in the management and care of ALS were identified and categorized. Furthermore, the amount of guidance underpinning these interventions and outcomes was analysed. Six clinical practice guidelines, one set of quality indicators and three evidence-based clinical summaries were identified. The results demonstrated that certain domains in ALS care, mainly disease-specific domains such as breathing and swallowing, are extensively addressed in the literature whereas other subjects, such as care coordination, receive little attention. In conclusion, this mapping review provides a scientific basis for targeting and developing the clinical content of a quality improvement intervention for the management of ALS.
PubMed | University of Pavia, Humanitas Materials Domini Hospital and Fondazione Salvatore Maugeri IRCCS
Type: | Journal: The breast journal | Year: 2016
The aim of this study was to demonstrate the correlation between human epidermal growth factor receptor 2 (HER2) overexpression and some poor prognosis factors in patients affected by ductal carcinoma in situ (DCIS). We evaluated 48 cases of DCIS, divided into two groups according to HER2 amplification status. Nuclear grade and cancerization of lobules were determined within primary DCIS and Ki67, estrogen receptor (ER), PR, and HER2 expression was established using immunohistochemistry. The histopathological variables in HER2-positive and in HER2-negative patients were compared to determine the recurrence risk. We also considered the median age at the time of surgery according to HER2 status. There were 11 recurrences (23%), 6 DCIS (55%), and 5 invasive cancer (45%). In an 8-year-long median follow-up, we hypothesized high risk of recurrence in HER2-positive DCIS. Patients with HER2-positive DCIS were younger than HER2-negative ones (p = 0.002). HER2-positive DCIS was also related to histopathological predictors of recurrence such as high nuclear grade (p < 0.001), high Ki67 expression (p = 0.003), low ER and PgR levels (p < 0.001), and the presence of cancerization of lobules (p < 0.049). Our trial suggests that HER2 amplification in primary DCIS is identified more frequently in younger patients and hypothesizes high risk of recurrence in HER2-positive DCIS related to histopathological predictors of overall relapse as high nuclear grade, high Ki67 expression, low ER and PgR levels, and the presence of cancerization of lobules. In HER2-positive DCIS, other variables of recurrence risk are compared to HER2-negative lesions, without statistical significance. Our results show that HER2 testing might suggest clinicians the optimal treatment of patients with DCIS.
Magri F.,University of Pavia |
Capelli V.,University of Pavia |
Rotondi M.,University of Pavia |
Leporati P.,University of Pavia |
And 6 more authors.
Endocrine-Related Cancer | Year: 2012
Estrogen receptor (ER) and androgen receptor (AR) may be expressed in thyroid tumors, but their prognostic role is controversial. We investigated whether ER and AR expressions could confer a more aggressive phenotype to thyroid tumors. We enrolled 91 patients (13 males and 78 females, mean age 49.3 ± 14.8 years) bearing small (T1 in the 2006 TNM system) differentiated thyroid cancers (DTC). Thirty-eight tumors were incidental histological findings. Using immunohistochemistry, we evaluated ERα, ERβ, and AR expressions in tumors and in its correspondent extra-tumor parenchyma. In tumors, 13 (16.7%) women and one (7.7%) man expressed ERα; 42 (53.8%) women and six (46%) men expressed ERβ; and 16 (20.5%) women and three (23.1%) men expressed AR. In normal thyroid parenchymas, ERb was expressed in 52 (66.7%) women and nine (69.2%) men, ERα in three (3.8%) women, and AR in 13 (16.7%) women. Compared with normal thyroid parenchyma, tumors gained ERα and lost ERβ expressions. Incidental cancers were more commonly ERα(-) than ERα(+) (47.7 vs 14.3%, P=0.037). Postsurgical serum thyroglobulin was higher in ERα(+) tumors than in the ERα(-) tumors (P=0.04). ERβ(+) tumors showed vascular invasion more frequently than the ERβ(+) tumors (26.2 vs 4.1%, P=0.005). AR(+) tumors showed capsular invasion more frequently than the AR(-) tumors (77.8 vs 46.6%, P=0.014). In conclusion, ERα positivity, ERβ negativity, and AR expressions are associated with a more aggressive phenotype of small T1-DTC. ER and AR expressions may represent an additional criterion in deciding whether to perform radioiodine ablation in these tumors. © 2012 Society for Endocrinology.
Bruletti G.,Servizio di Psicologia |
Comini L.,Fondazione Salvatore Maugeri IRCCS |
Scalvini S.,Servizio di Continuita Assistenziale Ospedaliera |
Morini R.,Divisione di Neurologia |
And 3 more authors.
Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration | Year: 2015
Our objective was to explore strain and needs in caregivers of advanced ALS patients and correlate this burden with patient's clinical condition and caregiver's sociodemographic status. Fifty-eight caregivers completed the Family Strain Questionnaire-short form (FSQ-SF) and Caregiver Needs Assessment (CNA) during patients' hospitalization (T0); 39 caregivers were reassessed at 6-12 months (T1) and 13 caregivers at 18-24 months (T2) follow-up. FSQ-SF and CNA total scores (CNA-T), including the CNA subscores 'Emotional/Social Support Needs' (CNA-E) and 'Information/Communication Needs' (CNA-I), were compared to patients' clinical condition (measured by ALSFRS-R and FVC %) and caregivers' sociodemographic status. Results showed that high strain level was found in 80% of caregivers and persisted over time. At T0, CNA-T was moderate and was not correlated to site of ALS onset, patients' clinical variables, or caregiver's sociodemographic characteristics; CNA-I subscore was significantly correlated to bulbar onset. CNA-T and CNA-I were significantly reduced at T1 (both, p < 0.01). Caregivers' parental relationship to patient (filial) and working status influenced caregivers' needs. After a longer follow-up (T2), CNA-E significantly decreased vs. T0 score (p < 0.02). In conclusion, over time, caregivers of advanced ALS patients show persisting high strain while needs decline, although the level still remains high. Further studies are needed to propose the most appropriate support. © 2014 Informa Healthcare.
Bazzini G.,Fondazione Salvatore Maugeri IRCCS
Giornale Italiano di Medicina del Lavoro ed Ergonomia | Year: 2010
A multidisciplinary (physiatrist, occupational physician, neurophysiologist, radiologist, etc.) and multiprofessional (occupational therapist, physiotherapist, ergonomist) strategy for rehabilitation and re-introduction of people with work-related injuries was tested at the "Fondazione Maugeri" Scientific Institue (Pavia, Italy).This process of re-introduction to work has several stages including increasing strength and resistance, specific occupational therapy activities to recover working functions and movements, aerobic training, prescription and allocation of any auxiliaries necessary, and inspections of the home and workplace. One particular feature is the final functional evaluation, whose aims are: to study the subject's "residual capacities" and "sustainable capacities", to supply useful information to the occupational physician in view of the verifying the patient's suitability for work, to contribute to "targeted" re-introduction, and to offer parameters useful for prevention and ergonomic planning. The main features of the disabled person which are studied are: degree of disability, motor capacity (joint movements, strength, resistance), cognitive-verbal functions, sensitivity and sensory functions, psychological and emotional components, need for auxiliaries, educational-professional aspects, possibility of autonomous transport, and motivation. © PI-ME, Pavia 2010.
Raglio A.,Fondazione Salvatore Maugeri I.R.C.C.S.
Giornale Italiano di Medicina del Lavoro ed Ergonomia | Year: 2012
This article review includes the controlled and randomized controlled trials about the use of music and music therapy techniques in the neuromotor rehabilitation. The paper defines the music therapy and delineates the neuroscientific bases and rehabilitative potential of music and music therapy interventions. Significant results are present in the stroke and Parkinson's disease rehabilitation. The Author's conclusions suggest the need of more rigorous studies based on clear procedures and strong methodological research criteria.
Masnaghetti S.E.,Fondazione Salvatore Maugeri I.R.C.C.S
Journal of Cardiovascular Medicine | Year: 2016
BACKGROUND AND AIMS: Hospitalized patients after acute cardiovascular events have poorer prognosis if glucose regulation is diagnosed as abnormal. We compared the short and long-term outcome of patients with newly diagnosed altered fasting glycemia (AFG) to that of known diabetic patients and patients with normal glucose regulation (NGR) after admission to cardiac rehabilitation. METHODS: We retrospectively analyzed 2490 consecutive patients. Three groups were identified: known diabetes mellitus (n?=?540, 22%), fasting glycemia above 110?mg/dl (AFG, n?=?269, 11%), and fasting glycemia 110?mg/dl or less (NGR, n?=?1681, 67%). Clinical variables, complications, and all-cause mortality were evaluated. RESULTS: At follow-up (median 3.1?±?2.4 years), after adjustment for age, sex, BMI, left ventricular ejection fraction, history of coronary artery disease, AFG had a significantly longer hospital stay versus NGR (21?±?8 versus 20?±?8 days; P?=?0.019) and higher risk of paroxysmal atrial fibrillation (P?=?0.041), pleural/pericardial effusions (P?0.001), skin complications (P?=?0.033), other events (P?=?0.001), and blood tests (urea: P?=?0.007; white blood cells: P?=?0.002; neutrophils: P?0.001; creatinine: P?=?0.022). All-cause mortality was significantly higher in diabetes mellitus versus NGR (odds ratio 1.61, 95% confidence interval 1.17–2.21); a nonsignificant trend was observed in AFG versus NGR (odds ratio 1.23, 95% confidence interval 0.77–1.98). CONCLUSIONS: A high AFG prevalence in cardiac patients admitted to rehabilitation was observed. AFG patients were more vulnerable than NGR patients, had higher complication rates independently of covariates, and required longer hospital stay. AFG was not a significant predictor of all-cause mortality at 3 years, whereas DM was. © 2016 Italian Federation of Cardiology. All rights reserved.