IRCCS Orthopedic Institute Galeazzi

Milano, Italy

IRCCS Orthopedic Institute Galeazzi

Milano, Italy

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Moja L.,University of Milan | Moja L.,IRCCS Orthopedic Institute Galeazzi | Kwag K.H.,IRCCS Orthopedic Institute Galeazzi | Lytras T.,Centers for Disease Control and Prevention | And 15 more authors.
American Journal of Public Health | Year: 2014

We systematically reviewed randomized controlled trials (RCTs) assessing the effectiveness ofcomputerized decision support systems (CDSSs) featuring rule- or algorithm-based software integrated with electronic health records (EHRs) and evidence-based knowledge. We searched MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and Cochrane Database of Abstracts of Reviews of Effects. Information on system design, capabilities, acquisition, implementation context, and effects on mortality, morbidity, and economic outcomes were extracted. Twenty-eight RCTs were included. CDSS use did not affect mortality (16 trials, 37395 patients; 2282 deaths; risk ratio [RR] = 0.96; 95%confidence interval [CI] = 0.85, 1.08; I2 = 41%).Astatistically significant effect was evident in the prevention ofmorbidity, any disease (9 RCTs; 13868 patients;RR = 0.82; 95% CI = 0.68, 0.99; I2 = 64%), but selectiveoutcomereporting or publication bias cannot be excluded. We observed differences for costs and health service utilization, although these were often small in magnitude. Across clinical settings, new generation CDSSs integrated with EHRs do not affect mortality and might moderately improvemorbidity outcomes. © 2013 American Public Health Association.


Danese S.,IRCCS Humanitas Research Hospital | Fiorino G.,IRCCS Humanitas Research Hospital | Peyrin-Biroulet L.,University of Lorraine | Lucenteforte E.,University of Florence | And 3 more authors.
Annals of Internal Medicine | Year: 2014

Biological agents are emerging treatment options for the management of ulcerative colitis (UC). Purpose: To assess the comparative efficacy and harm of biological agents in adult patients with moderately to severely active UC who are naive to biological agents. Data Sources: MEDLINE, EMBASE, and Cochrane Library from inception through December 2013, without language restrictions, and ClinicalTrials.gov, European Medicines Agency, and U.S. Food and Drug Administration Web sites. Study Selection: Randomized, placebo-controlled or head-to-head trials assessing biological agents as induction or maintenance therapy for moderately to severely active UC. Data Extraction: Two reviewers independently abstracted study data and outcomes and rated each trial's risk of bias. Data Synthesis: There were no head-to-head trials. There were 7 double-blind, placebo-controlled trials that were rated as low risk of bias and showed that all biological agents (adalimumab, golimumab, infliximab, and vedolizumab) resulted in more clinical responses, clinical remissions, and mucosal healings than placebo for induction therapy. The results of network meta-Analysis suggested that infliximab is more effective to induce clinical response (odds ratio, 2.36 [95% credible interval, 1.22 to 4.63]) and mucosal healing (odds ratio, 2.02 [95% credible interval, 1.13 to 3.59]) than adalimumab. No other indirect comparison reached statistical significance. For maintenance, 6 double-blind, placebo-controlled trials that were rated high risk of bias showed that all biological agents have greater clinical efficacy than placebo. The occurrence of adverse events was not different between biological agents and placebo. Limitation: Few trials, no head-to-head comparisons, and inadequate follow-up in maintenance trials. Conclusion: Biological agents are effective treatments for UC, but head-to-head trials are warranted to establish the best therapeutic option. Primary Funding Source: Centro Ricerca e Cura delle Malattie Infiammatorie Croniche Intestinali, IRCCS Istituto Clinico Humanitas. (PROSPERO registration number: CRD42013005459). © 2014 American College of Physicians.


Moja L.,IRCCS Orthopedic Institute Galeazzi | Moja L.,University of Milan | Pecoraro V.,IRCCS Orthopedic Institute Galeazzi | Ciccolallo L.,European Food Safety Authority | And 3 more authors.
European Journal of Clinical Investigation | Year: 2014

Background: Animal experiments should be appropriately designed, correctly analysed and transparently reported to increase their scientific validity and maximise the knowledge gained from each experiment. This systematic review of animal experiments investigating statins evaluates their quality of reporting and methodological aspects as well as their implications for the conduction of meta-analyses. Methods: We searched medline and embase for studies reporting research on statins in mice, rats and rabbits. We collected detailed information about the characteristics of studies, animals and experimental methods. Results: We retrieved 161 studies. A little over half did not report randomisation (55%) and most did not describe blinding (88%). All studies reported details on the experimental procedure, although many omitted information about animal gender, age or weight. Four percent did not report the number of animals used. None reported the sample size. Fixed- and random-effects models gave different results (ratio of effect size increased by five folds). Heterogeneity was consistently substantial within animal models, for which accounting for covariates had minimal impact. Publication bias is highly suspected across studies. Conclusions: Although statins showed efficacy in animal models, preclinical studies highlighted fundamental problems in the way in which such research is conducted and reported. Results were often difficult to interpret and reproduce. Different meta-analytic approaches were highly inconsistent: a reliable approach to estimate the true parameter was imperceptible. Policies that address these issues are required from investigators, editors and institutions that care about the quality standards and ethics of animal research. © 2014 Stichting European Society for Clinical Investigation Journal Foundation.


PubMed | Humanitas Clinical and Research Center, IRST Instituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS, Mario Negri Institute for Pharmacological Research, Duodecim Medical Publications Ltd and 5 more.
Type: Journal Article | Journal: Implementation science : IS | Year: 2016

Computerized decision support systems (CDSSs) are computer programs that provide doctors with person-specific, actionable recommendations, or management options that are intelligently filtered or presented at appropriate times to enhance health care. CDSSs might be integrated with patient electronic health records (EHRs) and evidence-based knowledge.The Computerized DEcision Support in ONCOlogy (ONCO-CODES) trial is a pragmatic, parallel group, randomized controlled study with 1:1 allocation ratio. The trial is designed to evaluate the effectiveness on clinical practice and quality of care of a multi-specialty collection of patient-specific reminders generated by a CDSS in the IRCCS Istituto Scientifico Romagnolo per lo Studio e la Curadei Tumori (IRST) hospital. We hypothesize that the intervention can increase clinician adherence to guidelines and, eventually, improve the quality of care offered to cancer patients. The primary outcome is the rate at which the issues reported by the reminders are resolved, aggregating specialty and primary care reminders. We will include all the patients admitted to hospital services. All analyses will follow the intention-to-treat principle.The results of our study will contribute to the current understanding of the effectiveness of CDSSs in cancer hospitals, thereby informing healthcare policy about the potential role of CDSS use. Furthermore, the study will inform whether CDSS may facilitate the integration of primary care in cancer settings, known to be usually limited. The increasing use of and familiarity with advanced technology among new generations of physicians may support integrated approaches to be tested in pragmatic studies determining the optimal interface between primary and oncology care.ClinicalTrials.gov, NCT02645357.


Negri E.,Instituto Of Ricovero E Cura A Carattere Scientifico Irccs | Zambelli A.,Unita Strutturale Complessa USC Oncologia | Franchi M.,Instituto Of Ricovero E Cura A Carattere Scientifico Irccs | Rossi M.,Instituto Of Ricovero E Cura A Carattere Scientifico Irccs | And 6 more authors.
Oncologist | Year: 2014

Background. The evidence supporting the use of trastuzumab (T) in a metastatic setting comes from studies that included (almost) only patients who never received prior T. We investigated the effectiveness of T as first-line therapy for metastatic breast cancer (mBC) in women previously treated with T in the adjuvant setting.Materials and Methods. By using record linkage of five administrative health care databases of Lombardy, Italy, we identified 2,046women treated with T for early breast cancer (eBC) in 2006-l2009, 96 of whom developed a metastasis and were retreated with T in first-line treatment for mBC (treatment group).We compared the overall survival (OS) of these women with that of 197 women treated with T in firstline treatment for mBC, who were treated with therapies other than T for early disease (control group).We computed Kaplan-Meier 2-year OS and used a proportional hazard model to estimate the multivariate hazard ratio (HR) of death in the intervention group compared with the control group, adjusted by age, use of endocrine therapy, and site of metastasis.Results. Two-year OS was 60.0% in the treatment group and 59.5% in the control group. The adjusted HR of death in the treatment group compared with the control group was 0.79 (95% confidence interval, 0.50–1.26).Conclusion. Our data provide convincing evidence that the outcome of women receiving first-line T treatment for mBC after T failure in the adjuvant setting is comparable to that of women not receiving T for eBC. These data are of specific interest, given the unavailability of data from randomized clinical trials. © AlphaMed Press 2014.


Lombardi G.,Irccs Orthopedic Institute Galeazzi | Lanteri P.,Irccs Orthopedic Institute Galeazzi | Colombini A.,Irccs Orthopedic Institute Galeazzi | Mariotti M.,Irccs Orthopedic Institute Galeazzi | And 3 more authors.
Journal of Biological Regulators and Homeostatic Agents | Year: 2012

Bone mass is the net product of formation and resorption, which are closely regulated by the equilibrium between endogenous/exogenous factors. Sclerostin inhibits the Wnt canonical signaling and is considered an anti-anabolic factor. We compared sclerostin serum concentrations between genders in athletes belonging to different sport disciplines, characterized by a different weight-bearing, and in their sedentary counterparts in order to study the possible link between bone metabolism in athletes and its peripheral concentration. We also compared sclerostin levels with bone alkaline phosphatase activity, a marker of bone formation. Sixty-one elite athletes, belonging to weight-bearing (15 male rugby players, 11 male enduro racers, 8 female basketball players), high-impact (6 male tennis players, 8 female ice skaters), non weight-bearing sports (13 male cyclists) and 16 sedentary controls were enrolled. Higher levels of sclerostin were found in females. Sclerostin was higher in weight-bearing than in non-weight-bearing disciplines in males. Significant inverse age-related correlation was found. Higher bone alkaline phosphatase activity was observed in females. The young adult elite athlete represents a peculiar physiologic model for studying sclerostin behavior: the applied load increased the marker concentrations, testifying a high bone turnover rate; however, a gender effect is evident. Copyright © by BIOLIFE, s.a.s.


Bonifazi M.,Pulmonary Diseases Unit | Zuccatosta L.,Pulmonary Diseases Unit | Trisolini R.,Maggiore Hospital | Moja L.,University of Milan | And 2 more authors.
Respiration | Year: 2013

Background: Transbronchial needle aspiration (TBNA) is a safe and useful sampling technique for the diagnosis of mediastinal adenopathies/masses, but its accuracy seems to be influenced by selected clinical and procedural aspects. Objectives: We performed a systematic review to identify the main predictors of a successful transbronchial aspirate according to different clinical settings. Methods: We searched Medline and Embase for all studies evaluating predictors of TBNA diagnostic yield, published up to February 2012. Two authors reviewed all titles/abstracts and retrieved the full text of articles that are potentially relevant to identify studies according to predefined selection criteria. The methodological quality of studies was assessed through the revised Quality Assessment of Diagnostic Accuracy Studies tool. Evidence synthesis was graded according to overall number of studies, patients involved and methodological features. Results: Fifty-three studies, involving more than 8,000 patients and evaluating 23 potential predictive factors, were included. Major predictors in an unselected population, as well as in patients with suspected/known lung cancer, included lymph node size (short axis length ≥2 cm), presence of abnormal endoscopic findings, subcarinal and right paratracheal location, and the use of histological needle by an experienced bronchoscopist. Stage I and sampling of more than one lymph node stations were the only predictors of a successful TBNA result in patients with suspected sarcoidosis. Conclusions: The diagnostic yield of TBNA depends on selected clinical and procedural features. Knowledge of factors that predict a positive TBNA result may help optimize the diagnostic success of the procedure in different clinical settings. Copyright © 2013 S. Karger AG, Basel.


Romano C.L.,IRCCS Orthopaedic Institute Galeazzi | Monti L.,IRCCS Orthopaedic Institute Galeazzi | Logoluso N.,IRCCS Orthopaedic Institute Galeazzi | Romano D.,IRCCS Orthopaedic Institute Galeazzi | Drago L.,IRCCS Orthopedic Institute Galeazzi
Knee Surgery, Sports Traumatology, Arthroscopy | Year: 2015

Purpose: The aim of the present study was to assess the efficacy of a thrombin-based topical haemostatic in reducing blood requirements after total knee replacement (TKR) revision surgery. Methods: This prospective, randomized, controlled study was designed to evaluate the haemostatic efficacy and safety of a thrombin-based topical haemostatic (Floseal) versus standard treatment in patients receiving total knee revision arthroplasty. The decrease in haemoglobin values postsurgery and the blood units transfused were recorded. The decision to transfuse was made by a surgeon blinded to the patient’s group allocation. Results: Forty-eight patients were enroled in the study; twenty-four patients each were randomized to the treatment and control groups, respectively. The median decrease in haemoglobin concentration on the first postoperative day was 2.2 g/dL in the treatment group and 2.7 g/dL in the control group. A significant reduction in units of blood transfused was also observed in the treatment group compared with the control group [1.1 ± 1.13 (range 0–4) vs. 1.9 ± 1.41 (range 0–5) blood units; P = 0.04]. No major treatment-related adverse events were recorded in the study. Conclusions: This study shows that a thrombin-based topical haemostatic reduces the need for blood transfusion in TKR revision surgery. Clinical relevance: A thrombin-based topical haemostatic agent can be an appropriate solution to enhance haemostasis and vessel sealing at the operative site in TKR revision surgery, in order to reduce the need for blood transfusion after surgery. Level of evidence: II. © 2014, Springer-Verlag Berlin Heidelberg.


Santesso N.,McMaster University | Rader T.,University of Ottawa | Nilsen E.S.,Norwegian Branch of the Nordic Cochrane Center | Glenton C.,Norwegian Branch of the Nordic Cochrane Center | And 7 more authors.
Journal of Clinical Epidemiology | Year: 2015

Objectives To evaluate a new format of a summary, which presents research from synthesized evidence to patients and the public. Study Design and Setting We conducted a randomized controlled trial in 143 members of the public from five countries (Canada, Norway, Spain, Argentina, and Italy). Participants received either a new summary format (a plain language summary [PLS]) or the current format used in Cochrane systematic reviews. The new PLS presents information about the condition and intervention, a narrative summary of results, and a table of results with absolute numbers for effects of the intervention and quality of the evidence using Grading of Recommendations Assessment, Development, and Evaluation. Results With the new PLS, more participants understood the benefits and harms and quality of evidence (53% vs. 18%, P < 0.001); more answered each of the five questions correctly (P≤ 0.001 for four questions); and they answered more questions correctly, median 3 (interquartile range [IQR]: 1-4) vs. 1 (IQR: 0-1), P < 0.001). Better understanding was independent of education level. More participants found information in the new PLS reliable, easy to find, easy to understand, and presented in a way that helped make decisions. Overall, participants preferred the new PLS. Conclusion This new PLS format for patients and the public is a promising tool to translate evidence from synthesized research. ©2015 The Authors.


Gianola S.,IRCCS Orthopedic Institute Galeazzi | Cattrysse E.,Vrije Universiteit Brussel | Provyn S.,Vrije Universiteit Brussel | Van Roy P.,Vrije Universiteit Brussel
Journal of Manipulative and Physiological Therapeutics | Year: 2015

Objective This study aimed to investigate the reproducibility of the kinematics in rotational high-velocity, low-amplitude (HVLA) thrust of the upper cervical spine. Methods Twenty fresh human cervical specimens were studied in a test-retest situation with 2 manual therapists. Kinematics of C1-C2 and C0-C1 were examined during segmental rotational HVLA manipulation through an ultrasound-based tracking system. The thrust moment was analyzed by 3-dimensional aspects: the range of motion of axial rotation, flexion-extension, lateral banding, and the cross-correlation between the axial rotation and the coupled lateral banding components. Results During rotational HVLA thrust on C1-C2, the main axial rotation demonstrates an intraexaminer relationship varying from almost perfect to fair (intraclass correlation coefficient = 0.71; intraclass correlation coefficient = 0.35) and a substantial interexaminer correlation of 0.73. Conclusions This study showed substantial levels of reliability for the main axial rotation component of segmental manual rotational HVLA thrust on C1-C2. Intra- and interrater reliability for flexion-extension, lateral bending, and cross-correlation was low. © 2015 National University of Health Sciences.

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