Adverse effects of immunotherapies for multiple sclerosis: A network meta-analysis

This is the protocol for a review and there is no abstract. The objectives are as follows: To compare adverse effects of immunotherapies for people with multiple sclerosis (MS) or clinically isolated syndrome (CIS), and to rank these treatments according to their relative risks of adverse effects

Effectiveness of a Hospital-Based Computerized Decision Support System on Clinician Recommendations and Patient Outcomes: A Randomized Clinical Trial.

IMPORTANCE: Sophisticated evidence-based information resources can filter medical evidence from the literature, integrate it into electronic health records, and generate recommendations tailored to individual patients. OBJECTIVE: To assess the effectiveness of a computerized clinical decision support system (CDSS) that preappraises evidence and provides health professionals with actionable, patient-specific recommendations at the point of care. DESIGN, SETTING, AND PARTICIPANTS: Open-label, parallel-group, randomized clinical trial among internal medicine wards of a large Italian general hospital. All analyses in this randomized clinical trial followed the intent-to-treat principle. Between November 1, 2015, and December 31, 2016, patients were randomly assigned to the intervention group, in which CDSS-generated reminders were displayed to physicians, or to the control group, in which reminders were generated but not shown. Data were analyzed between February 1 and July 31, 2018. INTERVENTIONS: Evidence-Based Medicine Electronic Decision Support (EBMEDS), a commercial CDSS covering a wide array of health conditions across specialties, was integrated into the hospital electronic health records to generate patient-specific recommendations. MAIN OUTCOMES AND MEASURES: The primary outcome was the resolution rate, the rate at which medical problems identified and alerted by the CDSS were addressed by a change in practice. Secondary outcomes included the length of hospital stay and in-hospital all-cause mortality. RESULTS: In this randomized clinical trial, 20 563 patients were admitted to the hospital. Of these, 6480 (31.5%) were admitted to the internal medicine wards (study population) and randomized (3242 to CDSS and 3238 to control). The mean (SD) age of patients was 70.5 (17.3) years, and 54.5% were men. In total, 28 394 reminders were generated throughout the course of the trial (median, 3 reminders per patient per hospital stay; interquartile range [IQR], 1-6). These messages led to a change in practice in approximately 4 of 100 patients. The resolution rate was 38.0% (95% CI, 37.2%-38.8%) in the intervention group and 33.7% (95% CI, 32.9%-34.4%) in the control group, corresponding to an odds ratio of 1.21 (95% CI, 1.11-1.32; P < .001). The length of hospital stay did not differ between the groups, with a median time of 8 days (IQR, 5-13 days) for the intervention group and a median time of 8 days (IQR, 5-14 days) for the control group (P = .36). In-hospital all-cause mortality also did not differ between groups (odds ratio, 0.95; 95% CI, 0.77-1.17; P = .59). Alert fatigue did not differ between early and late study periods. CONCLUSIONS AND RELEVANCE: An international commercial CDSS intervention marginally influenced routine practice in a general hospital, although the change did not statistically significantly affect patient outcomes. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02577198

Adverse effects of immunotherapies for multiple sclerosis : A network meta-analysis

This is the protocol for a review and there is no abstract. The objectives are as follows: To compare adverse effects of immunotherapies for people with multiple sclerosis (MS) or clinically isolated syndrome (CIS), and to rank these treatments according to their relative risks of adverse effects

3D printed dermatoscope stl files

STL files for 3D printing a medical grade dermatoscopeTHIS DATASET IS ARCHIVED AT DANS/EASY, BUT NOT ACCESSIBLE HERE. TO VIEW A LIST OF FILES AND ACCESS THE FILES IN THIS DATASET CLICK ON THE DOI-LINK ABOV

Control of scabies outbreaks in an Italian hospital: An information-centered management strategy

BACKGROUND: Scabies is a dermatologic infestation caused by Sarcoptes scabiei. In industrialized countries, hospitals and other health structures can sometimes be hit. The optimal management of scabies outbreaks still has to be established, mass prophylaxis being one possible option. METHODS: To identify the optimal approach to containing this re-emerging disease, a local health authority in Lombardy, Northern Italy, carried out an epidemiologic study into 2 scabies epidemics that took place from September to December 2012 in a 600-bed hospital with 26,000 admissions a year. RESULTS: Over a 3-month period, there were 12 cases of scabies on 4 wards; 43 contacts received prophylaxis. When the first cases were identified, an information campaign involving all hospital personnel was immediately set up. Regular staff meetings were organized, and information leaflets were distributed to patients. Family doctors of discharged patients were informed of the outbreak. CONCLUSION: A management model based on an information-centered strategy was used in place of mass prophylaxis to deal with scabies epidemics. The success of this approach was confirmed by the managers of the hospital involved (reduced expenditure for prophylactic drugs) and by hospital staff who did not have to deal with potential drug adverse effects

Sistemi computerizzati di supporto alle decisioni cliniche : l&apos;EBM al letto del malato = Computerized decision support systems : EBM at the bedside

Introduction. One of the aims of Evidence-Based Medicine is to improve quality and appropriateness of care by the expedition of the knowledge transfer process. Computerized Decision Support Systems (CDSSs) are computer programs that provide alerts to the prescribing doctor directly at the moment of medical examination. In fact, alerts are integrated within the single patient electronic health record. CDSS based on the best available and updated evidence and guidelines may be an efficient tool to facilitate the transfer of the latest results from clinical research directly at the bedside, thus supporting decisionmaking. Objectives. The CODES (COmputerized DEcision Support) trial is a research program funded by the Italian Ministry of Health and the Lombardy Region. It aims to evaluate the feasibility of the implementation of a CDSS at the hospital level and to assess its efficacy in daily clinical practice. Methods. The CODES project includes two pragmatic RCTs testing a CDSS (i.e. the EBMeDS - MediDSS) in two large Italian hospitals: the first is a general hospital in Vimercate (Lombardy), the second is an oncologic research center in Meldola (Emilia Romagna). The CDSS supports a full spectrum of decisions: therapy, drug interactions, diagnosis, and management of health care services are covered by a hundreds of reminders. However only few reminders are activated per patient, highlighting crucial problems in the delivery of high-quality care. The two trials have similar design and primary outcome, the rate at which alerts detected by the software are resolved by a decision of the clinicians. The project also includes the assessment of barriers and facilitators in the adoption of these new technologies by hospital staff members and the retrospective evaluation of the repeated risks in prescription habits. Results. The trials are ongoing and currently more than 10,000 patients have been random ized. The qualitative analysis revealed a progressive shift in the perception of the tool. Doctors are now seeing it as a trusted second opinion, available 24/7, which is tailored to the needs of the patient. The retrospective analysis showed the opportunity to achieve a better healthcare quality through an active risk management. Aggregating data from whole hospitals emerge rare drug interactions that otherwise would not be recognizable. Discussion. CDSS are promising tools to support clinicians in everyday practice. They can be used as a real time app or to perform retrospective analyses. These data can provide unique resources to hospital management

Air Pollution Impact on Pregnancy Outcomes in Como, Italy

Objective: This retrospective observational study investigates the association between maternal exposure to air pollutants and pregnancy adverse outcomes in low urbanization areas. Methods: We used multivariate regression analysis to estimate, in the Como province (2005\u20132012), the effects of NOx, NO2, SO2, O3, CO, and PM10 on low birth weight (LBW), babies small for gestational age (SGA), and preterm birth (PTB). Results: PTB was inversely associated with high (5.5mg/m3) exposure to SO2 (adjusted odds ratio [aOR]\ubc0.74, 95% confidence interval [95% CI]\ubc0.58\u20130.95) and to CO (1.8 mg/m3, aOR\ubc0.84, CI\ubc0.72\u20130.99). PTB risk increased with second trimester exposure to NOx (118.3mg/m3, aOR\ubc1.53, CI\ubc1.25\u20131.87), while LBW risk increased with third trimester PM10 (56.1mg/m3, aOR\ubc1.44, CI\ubc1.03\u20132.02). SGAwas inversely associated with third trimester NOx (115.8mg/m3, aOR\ubc0.89, CI\ubc0.79\u20130.99). Conclusions: Exposure to SO2 and CO seems to postpone delivery: a longer gestation could compensate for maternal hypoxemic-hypoxic damag

Air Pollution Impact on Pregnancy Outcomes in Como, Italy

Objective: This retrospective observational study investigates the association between maternal exposure to air pollutants and pregnancy adverse outcomes in low urbanization areas. Methods: We used multivariate regression analysis to estimate, in the Como province (2005–2012), the effects of NOx, NO2, SO2, O3, CO, and PM10 on low birth weight (LBW), babies small for gestational age (SGA), and preterm birth (PTB). Results: PTB was inversely associated with high (5.5mg/m3) exposure to SO2 (adjusted odds ratio [aOR]¼0.74, 95% confidence interval [95% CI]¼0.58–0.95) and to CO (1.8 mg/m3, aOR¼0.84, CI¼0.72–0.99). PTB risk increased with second trimester exposure to NOx (118.3mg/m3, aOR¼1.53, CI¼1.25–1.87), while LBW risk increased with third trimester PM10 (56.1mg/m3, aOR¼1.44, CI¼1.03–2.02). SGAwas inversely associated with third trimester NOx (115.8mg/m3, aOR¼0.89, CI¼0.79–0.99). Conclusions: Exposure to SO2 and CO seems to postpone delivery: a longer gestation could compensate for maternal hypoxemic-hypoxic damag

Adverse effects of immunotherapies for multiple sclerosis: a network meta-analysis

International audienceBackground: Multiple sclerosis (MS) is a chronic disease of the central nervous system that affects mainly young adults (two to three times more frequently in women than in men) and causes significant disability after onset. Although it is accepted that immunotherapies for people with MS decrease disease activity, uncertainty regarding their relative safety remains. Objectives: To compare adverse effects of immunotherapies for people with MS or clinically isolated syndrome (CIS), and to rank these treatments according to their relative risks of adverse effects through network meta-analyses (NMAs). Search methods: We searched CENTRAL, PubMed, Embase, two other databases and trials registers up to March 2022, together with reference checking and citation searching to identify additional studies. Selection criteria: We included participants 18 years of age or older with a diagnosis of MS or CIS, according to any accepted diagnostic criteria, who were included in randomized controlled trials (RCTs) that examined one or more of the agents used in MS or CIS, and compared them versus placebo or another active agent. We excluded RCTs in which a drug regimen was compared with a different regimen of the same drug without another active agent or placebo as a control arm. Data collection and analysis: We used standard Cochrane methods for data extraction and pairwise meta-analyses. For NMAs, we used the netmeta suite of commands in R to fit random-effects NMAs assuming a common between-study variance. We used the CINeMA platform to GRADE the certainty of the body of evidence in NMAs. We considered a relative risk (RR) of 1.5 as a non-inferiority safety threshold compared to placebo. We assessed the certainty of evidence for primary outcomes within the NMA according to GRADE, as very low, low, moderate or high. Main results: This NMA included 123 trials with 57,682 participants. Serious adverse events (SAEs). Reporting of SAEs was available from 84 studies including 5696 (11%) events in 51,833 (89.9%) participants out of 57,682 participants in all studies. Based on the absolute frequency of SAEs, our non-inferiority threshold (up to a 50% increased risk) meant that no more than 1 in 18 additional people would have a SAE compared to placebo. Low-certainty evidence suggested that three drugs may decrease SAEs compared to placebo (relative risk [RR], 95% confidence interval [CI]): interferon beta-1a (Avonex) (0.78, 0.66 to 0.94); dimethyl fumarate (0.79, 0.67 to 0.93), and glatiramer acetate (0.84, 0.72 to 0.98). Several drugs met our non-inferiority criterion versus placebo: moderate-certainty evidence for teriflunomide (1.08, 0.88 to 1.31); low-certainty evidence for ocrelizumab (0.85, 0.67 to 1.07), ozanimod (0.88, 0.59 to 1.33), interferon beta-1b (0.94, 0.78 to 1.12), interferon beta-1a (Rebif) (0.96, 0.80 to 1.15), natalizumab (0.97, 0.79 to 1.19), fingolimod (1.05, 0.92 to 1.20) and laquinimod (1.06, 0.83 to 1.34); very low-certainty evidence for daclizumab (0.83, 0.68 to 1.02). Non-inferiority with placebo was not met due to imprecision for the other drugs: low-certainty evidence for cladribine (1.10, 0.79 to 1.52), siponimod (1.20, 0.95 to 1.51), ofatumumab (1.26, 0.88 to 1.79) and rituximab (1.01, 0.67 to 1.52); very low-certainty evidence for immunoglobulins (1.05, 0.33 to 3.32), diroximel fumarate (1.05, 0.23 to 4.69), peg-interferon beta-1a (1.07, 0.66 to 1.74), alemtuzumab (1.16, 0.85 to 1.60), interferons (1.62, 0.21 to 12.72) and azathioprine (3.62, 0.76 to 17.19). Withdrawals due to adverse events. Reporting of withdrawals due to AEs was available from 105 studies (85.4%) including 3537 (6.39%) events in 55,320 (95.9%) patients out of 57,682 patients in all studies. Based on the absolute frequency of withdrawals, our non-inferiority threshold (up to a 50% increased risk) meant that no more than 1 in 31 additional people would withdraw compared to placebo. No drug reduced withdrawals due to adverse events when compared with placebo. There was very low-certainty evidence (meaning that estimates are not reliable) that two drugs met our non-inferiority criterion versus placebo, assuming an upper 95% CI RR limit of 1.5: diroximel fumarate (0.38, 0.11 to 1.27) and alemtuzumab (0.63, 0.33 to 1.19). Non-inferiority with placebo was not met due to imprecision for the following drugs: low-certainty evidence for ofatumumab (1.50, 0.87 to 2.59); very low-certainty evidence for methotrexate (0.94, 0.02 to 46.70), corticosteroids (1.05, 0.16 to 7.14), ozanimod (1.06, 0.58 to 1.93), natalizumab (1.20, 0.77 to 1.85), ocrelizumab (1.32, 0.81 to 2.14), dimethyl fumarate (1.34, 0.96 to 1.86), siponimod (1.63, 0.96 to 2.79), rituximab (1.63, 0.53 to 5.00), cladribine (1.80, 0.89 to 3.62), mitoxantrone (2.11, 0.50 to 8.87), interferons (3.47, 0.95 to 12.72), and cyclophosphamide (3.86, 0.45 to 33.50). Eleven drugs may have increased withdrawals due to adverse events compared with placebo: low-certainty evidence for teriflunomide (1.37, 1.01 to 1.85), glatiramer acetate (1.76, 1.36 to 2.26), fingolimod (1.79, 1.40 to 2.28), interferon beta-1a (Rebif) (2.15, 1.58 to 2.93), daclizumab (2.19, 1.31 to 3.65) and interferon beta-1b (2.59, 1.87 to 3.77); very low-certainty evidence for laquinimod (1.42, 1.01 to 2.00), interferon beta-1a (Avonex) (1.54, 1.13 to 2.10), immunoglobulins (1.87, 1.01 to 3.45), peg-interferon beta-1a (3.46, 1.44 to 8.33) and azathioprine (6.95, 2.57 to 18.78); however, very low-certainty evidence is unreliable. Sensitivity analyses including only studies with low attrition bias, drug dose above the group median, or only patients with relapsing remitting MS or CIS, and subgroup analyses by prior disease-modifying treatments did not change these figures. Rankings. No drug yielded consistent P scores in the upper quartile of the probability of being better than others for primary and secondary outcomes. Authors' conclusions: We found mostly low and very low-certainty evidence that drugs used to treat MS may not increase SAEs, but may increase withdrawals compared with placebo. The results suggest that there is no important difference in the occurrence of SAEs between first- and second-line drugs and between oral, injectable, or infused drugs, compared with placebo. Our review, along with other work in the literature, confirms poor-quality reporting of adverse events from RCTs of interventions. At the least, future studies should follow the CONSORT recommendations about reporting harm-related issues. To address adverse effects, future systematic reviews should also include non-randomized studies. Copyrigh