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

BACKGROUND: 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.

[Barriers and facilitators to the implementation of computerized decision support systems in Italian hospitals: a grounded theory study]. / Barriere e facilitatori all'implementazione dei sistemi di supporto decisionale computerizzati in ospedale: uno studio "grounded theory".

INTRODUCTION: Computerized Decision Support Systems (CDSSs) connect health care professionals with high-quality, evidence-based information at the point-of-care to guide clinical decision-making. Current research shows the potential of CDSSs to improve the efficiency and quality of patient care. The mere provision of the technology, however, does not guarantee its uptake. This qualitative study aims to explore the barriers and facilitators to the use of CDSSs as identified by health providers. METHODS: The study was performed in three Italian hospitals, each characterized by a different level of familiarity with the CDSS technology. We interviewed frontline physicians, nurses, information technology staff, and members of the hospital board of directors (n=24). A grounded theory approach informed our sampling criteria as well as the data collection and analysis. RESULTS: The adoption of CDSSs by health care professionals can be represented as a process that consists of six "positionings," each corresponding to an individual's use and perceived mastery of the technology. In conditions of low mastery, the CDSS is perceived as an object of threat, an unfamiliar tool that is difficult to control. On the other hand, individuals in conditions of high mastery view the CDSS as a helpful tool that can be locally adapted and integrated with clinicians' competences to fulfil their needs. In the first positionings, the uptake of CDSSs is hindered by representational obstacles. The last positionings, alternatively, featured technical obstacles to CDSS uptake. DISCUSSION: Our model of CDSS adoption can guide hospital administrators interested in the future integration of CDSSs to evaluate their organizational contexts, identify potential challenges to the implementation of the technology, and develop an effective strategy to address them. Our findings also allow reflections concerning the misalignment between most Italian hospitals and the current innovation trends toward the uptake of computerized decision support technologies.

Mitigating Disputes Originated by Multiple Discordant Systematic Reviews and Meta-Analyses: A Survey of Methodologists and Clinicians.

Background: Overlapping systematic reviews (SRs) are increasingly frequent in the medical literature. They can easily generate discordant evidence, as estimates of effect sizes and their interpretation might differ from one source to another. Objective: To analyze how methodologists and clinicians make a decision when faced with discordant evidence formalized in structured tables. Methods: We conducted a 16-item survey exploring how methodologists and clinicians would react when presented with multiple Summary of Findings (SoF) tables (generated using the GRADE tool) derived from 4 overlapping and discordant SRs and meta-analyses on thrombolytic therapy for intermediate-risk pulmonary embolism. SoF tables reported 4 different magnitudes of effects and overall certainty. Participants were asked to provide their recommendations regarding the intervention and the reasons behind their conclusion. Results: Of the 80 invitees, 41 (51%) participated. The majority described themselves as "somewhat familiar" or experts with SoF tables. The majority recommended the therapy (pharmacological systemic thrombolysis), grading the recommendation as weak positive. Certainty of evidence and benefit-risk balance were the two criteria that prevailed in generating the recommendation. When faced with overlapping meta-analyses, the preferred approach was to use only high-quality SRs and exclude redundant SRs. Several participants suggested integrating the SoF tables with additional information, such as a more comprehensive evaluation of the risk of bias of systematic reviews (71%), heterogeneity/inconsistency (68%) and studies included within each SR (62%). Conclusion: When faced with multiple controversial SR results, the type and completeness of reported information in SoF tables affect experts' ability to make recommendations. Developers of the SoF table should consider collating key information from overlapping and potentially discordant reviews.

[10 years of stagnant clinical research in the Italian academic context.] / Dieci anni di stagnazione della ricerca, non solo clinica, nel contesto accademico italiano.

This article is about current challenges to evidence-based medicine (EMB) in Italy. The authors, who share a 20-year commitment to the field of clinical research, discuss what they define as a phase of "stagnation" in practicing and teaching methods and research tactics, both in clinical and academic settings. Early success of EBM cultural movement was not persistent. The authors reason about how the teaching of EBM has remained a niche, concerning few professionals compared to the needs of the country. The authors identify some reasons that might have led to inconsistent attention to research methodology and address ways to strengthen the contribution of academic medicine to clinical research.

An open-access and inexpensive 3D printed otoscope for low-resource settings and health crises.

Limited access to key diagnostic tools is detrimental to priority health needs of populations. Ear pain, tenderness, itching, and different degree of hearing loss are common problems which require otoscopy as first diagnostic assessment. Where an otoscope is not available because of budget constraints, a self-fabricated low-cost otoscope might represent a feasible opportunity. In this paper, we share the design and construction process of an open-source, 3D printed, otoscope. The prototype was compared to a commercial solution, demonstrating similar overall quality between the instruments.

3D printing technology and internet of things prototyping in family practice: building pulse oximeters during COVID-19 pandemic.

Family doctors can have an active role in identifying significant population needs and solutions. During the COVID-19 epidemic, patient home monitoring with pulse oximetry has been a key aspect of care of patients. However, pandemics bring shortage of medical equipment such as pulse oximeters. Through the local maker community, in a matter of days four "smart" pulse oximeters were built. Following Internet of Things principles, the prototypes were programmed to transmit real-time data through Wi-Fi directly to the doctors. Each pulse oximeter served a family doctor during the pandemic. In this article we describe the process that led to the production of the technology and provide detailed instructions, which have also been shared in maker-oriented websites. Dissemination can potentially lead to additional small-scale productions, limiting future shortages.

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.

Quality assessment versus risk of bias in systematic reviews: AMSTAR and ROBIS had similar reliability but differed in their construct and applicability.

OBJECTIVES: The objective of the study was to assess the inter-rater reliability (IRR) of AMSTAR and ROBIS in judging individual domains and overall methodological quality/risk of bias of systematic reviews, the concurrent validity of the tools, and the time required to apply them. STUDY DESIGN AND SETTING: This is a cross-sectional study. Five raters independently read 31 systematic reviews and applied AMSTAR and ROBIS. Fleiss' k for multiple raters for individual domains and overall methodological quality/risk of bias was calculated. Similar domains assessed by both tools and final scores were matched to explore the concurrent validity, using the Kendall tau correlation. RESULTS: IRR ranged from fair to perfect for AMSTAR and from moderate to substantial for ROBIS. Kappa for overall quality/risk of bias was 0.73 (95% confidence interval [CI] 0.65-0.81) for AMSTAR and 0.64 (95% CI 0.54-0.74) for ROBIS. We judged most of the reviews at intermediate quality with AMSTAR (53%), while judgments were split in high (53%) and low (47%) risk of bias with ROBIS. The correlation between judgments on similar domains ranged from moderate to high, while it was fair on the overall judgment (K = 0.35, 95% CI 0.21-0.49). The mean time to complete ROBIS was about double that for AMSTAR. CONCLUSION: AMSTAR and ROBIS offer similar IRR but differ in their construct and applicability.

[EBM, guidelines, protocols: knowledge, attitudes and utilization in the era of law on professional responsibility and safety of health care.] / EBM, linea guida, protocolli: conoscenze, attitudini e utilizzo all'epoca della legge sulla responsabilità professionale e sicurezza delle cure.

INTRODUCTION: The knowledge of principles and methods of Evidence Based Medicine (EBM) and the use of Clinical Practice Guidelines to inform clinical decisions are recognised as key instruments to improve the quality of care. In Italy the Parliament has revised the legal system that rules the responsibilities of health professionals and health care safety, prescribing health professionals to adhere to guidelines and good practice recommendations. The objective of the study was to evaluate guidelines and clinical pathways developed at local level and to assess knowledge and attitudes of healthcare workers toward EBM and guidelines. METHODS: At the l'ASL 5 Liguria La Spezia we performed a census of all the documents registered as "guidelines" or "clinical pathways" at the Direzione Generale by the end of May 2016. We assessed their methodological quality by the "Recognition Card for Clinical Pathways Production and Revision Activity" prepared by the Ligurian Region. We conducted semi-structured interviews to assess attitudes and knowledge of healthcare workers. RESULTS: We found 17 clinical pathways, 41% contained organizational/management recommendations, and 59% contained mainly clinical recommendations. 41% was produced by assimilating already existing guidelines. 29% did not describe the method of production. Only one document linked directly each recommendation with scientific evidence. 10 healthcare workers out of 32 invited actually accepted to conduct the interview. Respondents showed a positive attitude toward the EBM and guidelines but a poor knowledge of the methodology of production and the instruments and principles for critical appraising of scientific literature. Nobody knew the GRADE approach. The most relevant barriers identified were: lack of time, poor knowledge of English and statistical methods, poor applicability of the international guidelines to local setting and real patients encountered in clinical practice. DISCUSSION: Despite the initiatives of the legislator toward civil responsibility and safety of care that should increase the use of guidelines, we found an overall poor knowledge of the concepts of EBM and method of guidelines production. Though the attitudes of responders to the interview were positive, barriers to use seemed to be predominant and considered more as obstacles than as a stimulus. In peripheral settings or in hospitals of medium/small size, clinical guidelines could remain confined to a merely juridical role, with weak impact on professional practice.

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 NO(x), 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 (5.5 µg/m³) exposure to SO2 (adjusted odds ratio [aOR] = 0.74, 95% confidence interval [95% CI] = 0.58-0.95) and to CO (1.8 mg/m³, aOR = 0.84, CI = 0.72-0.99). PTB risk increased with second trimester exposure to NO(x) (118.3 µg/m³, aOR = 1.53, CI = 1.25-1.87), while LBW risk increased with third trimester PM10 (56.1 µg/m³, aOR = 1.44, CI = 1.03-2.02). SGA was inversely associated with third trimester NO(x) (115.8 µg/m³, aOR = 0.89, CI = 0.79-0.99). CONCLUSIONS: Exposure to SO2 and CO seems to postpone delivery: a longer gestation could compensate for maternal hypoxemic-hypoxic damage.

[Computerized decision support systems: EBM at the bedside]. / Sistemi computerizzati di supporto alle decisioni cliniche: l'EBM al letto del malato.

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 decision-making. 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 randomized. 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.

Implementing an evidence-based computerized decision support system to improve patient care in a general hospital: the CODES study protocol for a randomized controlled trial.

BACKGROUND: Computerized decision support systems (CDSSs) are information technology-based software that provide health professionals with actionable, patient-specific recommendations or guidelines for disease diagnosis, treatment, and management at the point-of-care. These messages are intelligently filtered to enhance the health and clinical care of patients. CDSSs may be integrated with patient electronic health records (EHRs) and evidence-based knowledge. METHODS/DESIGN: We designed a pragmatic randomized controlled trial to evaluate the effectiveness of patient-specific, evidence-based reminders generated at the point-of-care by a multi-specialty decision support system on clinical practice and the quality of care. We will include all the patients admitted to the internal medicine department of one large general hospital. The primary outcome is the rate at which medical problems, which are detected by the decision support software and reported through the reminders, are resolved (i.e., resolution rates). Secondary outcomes are resolution rates for reminders specific to venous thromboembolism (VTE) prevention, in-hospital all causes and VTE-related mortality, and the length of hospital stay during the study period. DISCUSSION: The adoption of CDSSs is likely to increase across healthcare systems due to growing concerns about the quality of medical care and discrepancy between real and ideal practice, continuous demands for a meaningful use of health information technology, and the increasing use of and familiarity with advanced technology among new generations of physicians. The results of our study will contribute to the current understanding of the effectiveness of CDSSs in primary care and hospital settings, thereby informing future research and healthcare policy questions related to the feasibility and value of CDSS use in healthcare systems. This trial is seconded by a specialty trial randomizing patients in an oncology setting (ONCO-CODES). TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show/NCT02577198?term=NCT02577198&rank=1.

Implementing an evidence-based computerized decision support system linked to electronic health records to improve care for cancer patients: the ONCO-CODES study protocol for a randomized controlled trial.

BACKGROUND: 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. METHODS/DESIGN: 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 Cura dei 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. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02645357.

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.

Achieving vocational training goals during six months in an Italian general practice.

BACKGROUND: General practice training in Europe is still an unresolved issue. Italy has developed a formation course similar to specialty schools, awarding a certificate of attendance at the end of a 3-year period. Its training goals are defined mainly as work hours in medical facilities, including two semesters at two general practices. OBJECTIVES: To evaluate if a registrar, during a semester in a general practice, has access to a case spectrum consistent enough to achieve the training goals, both 'methodological' (work organization targets) and 'specific' (targets of opportunity). METHODS: During a six-month period, every patient contact qualified for tutoring was recorded. For each visit, access mode and priority, patient name, age, patient reason for encounter (RFE), diagnosis, referrals, prescribed laboratory tests and treatment were recorded. Data was evaluated as in other Italian medical specialties; i.e. compared to target numbers. RESULTS: A total of 1 828 contacts and 2 437 RFE in 122 work days were recorded. There were 1 007 and 613 contacts with and without appointment respectively, 88 'family contacts,' 44 scheduled check-ups, 11 phone contacts, and 65 nurse interventions. Of all contacts, 9.8% were indirect. In six months, we had at least one contact with 792 patients out of 1 500 (52.8%). Main RFE resulted from respiratory and musculoskeletal symptoms while most frequent diagnoses belonged to musculoskeletal, cardiovascular and respiratory fields. CONCLUSIONS: A six months training period can be sufficient for representing a general practitioner's work organization and primary care epidemiology. However, deficiencies were observed.