Exploring inconsistencies between observational and experimental studies of selenium and diabetes risk.

Background: Observational and experimental epidemiologic studies that have addressed the relation between intake of the trace element selenium and cancer risk have yielded strongly conflicting results, as recently reported by a Cochrane review. Most observational studies suggest an inverse association, while randomized controlled trials (RCTs) have indicated a null or direct relation. Little is known about the replication of such inconsistencies when dealing with the risk of other chronic disease. Objectives: We investigated the results of observational and experimental studies linking selenium exposure to the occurrence of type 2 diabetes. Methods: After a literature search we identified 12 observational studies (8 cross-sectional and 4 cohort) and 5 RCTs. Using a random-effects model, we computed the summary relative risk (RR) of type-2 diabetes along with its 95% confidence interval (CI) in subjects with the highest versus the lowest selenium exposure category in observational studies, and in subjects allocated to selenium compared to placebo in the RCTs. Results: Summary RRs were 1.98 (95% CI 1.22-3.23) and 1.13 (0.15-8.45) for cross-sectional studies using serum and toenail selenium for exposure assessment, respectively. Cohort studies based on toenail selenium yielded a summary RR of 0.78 (0.62-0.98), while the only study assessing dietary selenium intake gave a RR of 2.39, (1.32-4.32). For RCTs, summary RR was 1.10 (1.00-1.21) among selenium-supplemented versus placebo. The distinctive feature of the two observational studies (one cross-sectional and one prospective) that failed to find an excess diabetes risk associated with higher selenium exposure was that the subjects were health professionals. Age, gender, study area and other demographic characteristics did not appear to have influenced the results. Conclusions: These results suggest that the ability of observational studies to predict results of RCTs when addressing the health effects of selenium may differ on the basis of the outcome studied (diabetes versus cancer) as well as the indicator used for exposure assessment and the type of population under study

Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis

Different therapeutic strategies are available for the treatment of people with relapsing-remitting multiple sclerosis (RRMS), including immunomodulators, immunosuppressants and biologics. Although there is consensus that these therapies reduce the frequency of relapses, their relative benefit in delaying new relapses or disability worsening remains unclear due to the limited number of direct comparison trials

Antiplatelet drugs for secondary prevention in patients with ischemic stroke or transient ischemic attack: a systematic review and network meta-analysis.

BACKGROUND Antiplatelet drugs may prevent recurrent ischemic events after ischemic stroke but their relative effectiveness and harms still need to be clarified. Within this network meta-analysis we aimed to summarize the current evidence for using antiplatelet drugs for secondary stroke prevention. METHODS We searched MEDLINE, EMBASE and CENTRAL up to September 2020. Randomized controlled trials (RCTs) assessing antiplatelet drugs for secondary stroke prevention were included. We did pairwise meta-analyses and network meta-analyses using random-effects models. Primary outcomes were all strokes (ischemic or hemorrhagic) and all-cause mortality. RESULTS The review included 57 RCTs, 50 (n = 165,533 participants) provided data for the meta-analyses. Compared to placebo/no treatment, moderate to high-confidence evidence indicated that cilostazol, clopidogrel, dipyridamole + aspirin, ticagrelor, ticlopidine, and aspirin ≤ 150 mg/day significantly reduced the risk of all strokes (odds ratios, ORs and absolute risk difference, ARD): cilostazol 0.51 (95 % confidence interval, CI, 0.37 to 0.71; 3.6 % fewer), clopidogrel 0.63 (95 % CI, 0.49 to 0.79; 2.7 % fewer), dipyridamole + aspirin 0.65 (95 % CI, 0.55 to 0.78; 2.5 % fewer), ticagrelor 0.68 (95 % CI, 0.50 to 0.93; 2.3 % fewer), ticlopidine 0.74 (95 % CI 0.59 to 0.93; 1.9 % fewer), aspirin ≤ 150 mg/day 0.79 (95 % CI, 0.66 to 0.95; 1.5 % fewer). Aspirin > 150 mg/day and the combinations clopidogrel/aspirin, ticagrelor/aspirin, also decrease all strokes but increase the risk of hemorrhagic events. Only aspirin > 150 mg/day significantly reduced all-cause mortality (OR 0.86, 95 % CI 0.76 to 0.97; ARD 0.9 %, 95 %CI 1.5-0.2 % fewer, moderate confidence). Compared to aspirin ≤ 150 mg/day, clopidogrel significantly reduced the risk of all strokes, cardiovascular events, and intracranial hemorrhage outcomes. Cilostazol also appeared to provide advantages but data are limited to the Asian population. CONCLUSIONS Considering the benefits and harms ratio, cilostazol, clopidogrel, dipyridamole + aspirin, ticagrelor, ticlopidine, and aspirin ≤ 150 mg/day appear to be the best choices as antiplatelet drugs for secondary prevention of patients with ischemic stroke or TIA. SYSTEMATIC REVIEW REGISTRATION PROSPERO CRD42020159896

The undergraduate nursing student evaluation of clinical learning environment: an Italian survey [La valutazione dell'ambiente di apprendimento clinico da parte degli studenti del Corso di Laurea in Infermieristica: una indagine italiana]

BACKGROUND: Nursing students have to deal with many different clinical and practical aspects of knowledge to become skilled professionals. Student perception may be considered an indicator of teaching quality, since positive perception of students is strictly related to their effective professional learning. The Clinical Learning Environment and Supervision plus Nurse Teacher (CLES+T) scale is considered the gold standard psychometric instrument to evaluate both the quality and the climate of clinical learning environment. AIMS: To evaluate the quality of nurse teaching by means of CLES+T scale and to highlight significant correlations between CLES+T scale and selected characteristics of both students and clinical environments. METHODS: On 4 March 2013, a cross-sectional survey was conducted at University of Modena: CLES+T scale was administered during a plenary convocation to 242 nursing students who attended the second and third years of Nursing Degree. All 34 items of the scale were statistically analysed using the median test. RESULTS: The median values were uniformly represented by "4" level (on the Likert scale). The final marks of clinical learning experience were the only variable statistically significantly related to the scale scores. The paediatrics and emergency areas obtained the highest scale scores. CONCLUSIONS: The nursing student evaluations were uniformly positive and related to their positive final marks. A positive ward atmosphere was identified as especially important in this study. These data indicate that a non-hostile and hospitable environment can favour the best clinical learning. We conclude that CLES+T scale can be a useful instrument to explore the clinical climate in all hospital areas and to highlight critical clinical situations

A systematic review and meta-analysis investigating the relationship between metabolic syndrome and the incidence of thyroid diseases.

PURPOSE To assess the prospective association between metabolic syndrome (MetS), its components, and incidence of thyroid disorders by conducting a systematic review and meta-analysis. METHODS A systematic search was performed in Ovid Medline, Embase.com, and Cochrane CENTRAL from inception to February 22, 2023. Publications from prospective studies were included if they provided data on baseline MetS status or one of its components and assessed the incidence of thyroid disorders over time. A random effects meta-analysis was conducted to calculate the odds ratio (OR) for developing thyroid disorders. RESULTS After full-text screening of 2927 articles, seven studies met our inclusion criteria. Two of these studies assessed MetS as an exposure (N = 71,727) and were included in our meta-analysis. The association between MetS at baseline and incidence of overt hypothyroidism at follow-up yielded an OR of 0.78 (95% confidence interval [CI]: 0.52-1.16 for two studies, I2 = 0%). Pooled analysis was not possible for subclinical hypothyroidism, due to large heterogeneity (I2 = 92.3%), nor for hyperthyroidism, as only one study assessed this association. We found evidence of an increased risk of overt (RR: 3.10 (1.56-4.64, I2 = 0%) and subclinical hypothyroidism (RR 1.50 (1.05-1.94), I2 = 0%) in individuals with obesity at baseline. There was a lower odds of developing overt hyperthyroidism in individuals with prediabetes at baseline (OR: 0.68 (0.47-0.98), I2 = 0%). CONCLUSIONS We were unable to draw firm conclusions regarding the association between MetS and the incidence of thyroid disorders due to the limited number of available studies and the presence of important heterogeneity in reporting results. However, we did find an association between obesity at baseline and incidence of overt and subclinical hypothyroidism

Comparative cardiovascular side effects of medications for attention-deficit/hyperactivity disorder in children, adolescents and adults: protocol for a systematic review and network meta-analysis.

INTRODUCTION Pharmacotherapy is an important component of the multimodal treatment of attention-deficit/hyperactivity disorder (ADHD). Cardiovascular safety of medications for ADHD is of concern from a clinical and public health standpoint. We aim to conduct a network meta-analysis (NMA) comparing the effects of available medications for ADHD on blood pressure (diastolic and systolic), heart rate and ECG parameters over the short-term and long-term treatment. METHODS AND ANALYSIS Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines for protocols and NMAs will be followed. We will include parallel group or cross-over randomised controlled trials (RCTs) conducted in patients with a primary diagnosis of ADHD (no age limits). We will search an extensive number of electronic databases (including MEDLINE, CINAHL, CENTRAL, EMBASE, ERIC, PsycINFO, OpenGrey, Web of Science) from their inception and contact study authors/drug manufacturers to gather relevant unpublished information. No language restrictions will be applied. The main outcomes (assessed at 12 weeks, 26 weeks and 52 weeks) will be: (1) change in diastolic and systolic blood pressure (mm Hg); (2) change in heart rate, measured in beats/min; (3) change in any available ECG parameters. We will conduct random effects of NMA using standardised mean differences with 95% CIs for continuous outcomes and ORs with 95% CIs for dichotomous outcomes. We will use the Cochrane risk of bias tool-version 2 to assess the risk of bias of included RCTs and the Confidence In Network Meta-Analysis tool to evaluate the confidence of evidence contributing to each network estimate. Sensitivity analyses will investigate effects at different dose regimens. ETHICS AND DISSEMINATION No institutional review board approval will be necessary. The results of this systematic review and meta-analysis will be presented at national and international conferences and published in peer-reviewed journals. PROSPERO REGISTRATION NUMBER CRD42021295352

Pharmacological and non-pharmacological interventions for adults with ADHD: protocol for a systematic review and network meta-analysis.

INTRODUCTION It is unclear how pharmacological and non-pharmacological interventions compare with each other in terms of efficacy and tolerability for core symptoms and additional problems in adults with attention-deficit/hyperactivity disorder (ADHD). We aim to conduct the first network meta-analysis (NMA) comparing pharmacological and non-pharmacological interventions (or their combinations) in adults with ADHD. METHODS AND ANALYSIS We will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement for NMAs. We will search a broad set of electronic databases/registries and contact drug companies and experts in the field to retrieve published and unpublished randomised controlled trials (RCTs) (parallel or cross-over) of medications (either licensed or unlicensed) and any non-pharmacological intervention in adults (≥18 years) with ADHD. Primary outcomes will be: (1) change in severity of ADHD core symptoms, and (2) acceptability (all-cause discontinuation). Secondary outcomes will include tolerability (drop-out due to side effects) and change in the severity of emotional dysregulation, executive dysfunctions and quality of life. The risk of bias in each individual RCT included in the NMA will be assessed using the Cochrane Risk of Bias tool-version 2. We will evaluate the transitivity assumption comparing the distribution of possible effect modifiers across treatment comparisons. We will perform Bayesian NMA for each outcome with random-effects model in OpenBUGS. Pooled estimates of NMA will be obtained using the Markov Chains Monte Carlo method. We will judge the credibility in the evidence derived from the NMA using the CINeMA tool (which includes assessment of publication bias). We will conduct a series of sensitivity analyses to assess the robustness of the findings. ETHICS AND DISSEMINATION As this is the protocol for an aggregate-data level NMA, ethical approval will not be required. Results will be disseminated at national/international conferences and in peer-reviewed journals. PROSPERO REGISTRATION NUMBER CRD42021265576

Medication-related visits in a pediatric emergency department: an 8-years retrospective analysis

There are limited data on the characterization of medication-related visits (MRVs) to the emergency department (ED) in pediatric patients in Italy. We have estimated the frequency, severity, and classification of MRVs to the ED in pediatric patients