Exploring correlation between early clinical skills teaching and self-reported competence of senior medical students; a cross-sectional study

Η εκπαίδευση σε συνθήκες προσομοίωσης σε συνδυασμό με την πρακτική άσκηση υπό επίβλεψη σε πραγματικούς ασθενείς, αποτελούν δύο απαραίτητα βήματα για την ασφαλή και συστηματική εκπαίδευση στις κλινικές δεξιότητες. Η οικοδόμηση της αυτοεκτίμησης των φοιτητών ιατρικής κατά τη διάρκεια των σπουδών τους είναι ζωτικής σημασίας, αλλά δεν αρκεί για να εξασφαλίσει την επιτυχή πραγματοποίηση κλινικών δεξιοτήτων. O σκοπός της μελέτης ήταν να αξιολογήσει την αυτο-αναφερόμενη ικανότητα σε βασικές κλινικές δεξιότητες φοιτητών μεγαλυτέρων ετών της ιατρικής, πριν από την αποφοίτησή τους και να διερευνήσει πιθανές συσχετίσεις με την πρώιμη εκπαίδευση κλινικών δεξιοτήτων σε συνθήκες προσομοίωσης. Μέθοδος: Πραγματοποιήσαμε μια συγχρονική μελέτη σε τελειόφοιτους φοιτητές ιατρικής ένα μήνα πριν από την αποφοίτησή τους. Καλέσαμε τους φοιτητές να κάνουν την αυτοεκτίμηση των ικανοτήτων τους σε 42 βασικές κλινικές δεξιότητες χρησιμοποιώντας ένα ανώνυμο ερωτηματολόγιο μέσω διαδικτύου. Τα δεδομένα αναλύθηκαν λαμβάνοντας υπόψη την προηγούμενη συμμετοχή των φοιτητών στο επιλεγόμενο μάθημα «Εργαστήριο Κλινικών Δεξιοτήτων» (ΕΚΔ). Αποτελέσματα: Η απαντητικότητα των τελειόφοιτων φοιτητών ιατρικής στην ηλεκτρονική μας μελέτης ήταν 24,6%. Τριάντα τέσσερις φοιτητές (38,6%) είχαν παρακολουθήσει το επιλεγόμενα μάθημα ΕΚΔ. Η παρακολούθηση του ΕΚΔ φάνηκε να επηρεάζει την αυτοεκτίμηση της ικανότητας των φοιτητών στην πραγματοποίηση των 15 δεξιοτήτων που διδάσκονται στο επιλεγόμενο μάθημα, σε σχέση με τους φοιτητές που δεν το έχουν παρακολουθήσει (p>0,05). Δεν υπήρχε στατιστικά σημαντική διαφορά μεταξύ των δύο ομάδων φοιτητών σε σχέση με τις άλλες βασικές δεξιότητες που δεν διδάχθηκαν στο ΕΚΔ. Συμπεράσματα: Τα αποτελέσματά μας δείχνουν ότι οι τελειόφοιτοι φοιτητές ιατρικής δεν αισθάνονται αρκετά ικανοί να επιτελέσουν τις βασικές κλινικές δεξιότητες που πρέπει να καλύπτει το προπτυχιακό πρόγραμμα σπουδών της ιατρικής. Η συστηματική εκπαίδευση στις κλινικές δεξιότητες στα πρώτα χρόνια των ιατρικών σπουδών πριν από την επαφή με τους ασθενούς φαίνεται να είναι αρκετή για να αλλάξει την αυτοεκτίμηση των τελειόφοιτων φοιτητών ιατρικής στην πραγματοποίηση επιλεγμένων κλινικών δεξιοτήτων.Introduction: Simulation-based teaching combined with supervised clinical practice, are the necessary steps for safe and systematic clinical skills education. Building medical students’ self-esteem during their undergraduate studies has a positive effect in their competence but is not sufficient to ensure successful clinical skills performance. The aim of the study was to assess senior medical students’ self-reported competence before graduation in basic clinical skills and explore potential correlations with early simulation-based clinical skills teaching. Methods: We conducted a cross-sectional study in final-year medical students one month before their graduation. We invited senior medical students to self-report their competence in 42 basic clinical skills using an online anonymous questionnaire. Medical students’ participation in the clinical skills lab (CSL) elective course was the main factor of analysis. Results: Senior medical students’ response rate in our electronic study was 24.6%. Thirty-four students (38.6%) have attended CSL elective course. Attending CSL seemed to influence senior medical students’ self-reported competence in performing the 15 skills taught in the elective course in comparison with students who have not attended it (p>0.05). There was no statistical difference between the two groups in regard to other basic skills that were not taught in the CSL. Conclusion: Our results indicate that senior medical students do not feel competent enough to perform basic clinical skills that the undergraduate medical curricula should cover. Systematic clinical skills teaching in early years of medical studies before patient contact seemed to be enough to change senior medical students’ self-reported competence in specific clinical skills

Prevention of orthodontic enamel demineralization: a systematic review with meta‐analyses

Aim of this systematic review was to assess the efficacy of preventive interventions against the development of white spot lesions (WSLs) during fixed appliance orthodontic treatment. Nine databases were searched without limitations in September 2018 for randomized trials. Study selection, data extraction and risk of bias assessment were done independently in duplicate. Random-effects meta-analyses of mean differences (MDs) or relative risks (RRs) with their 95% confidence intervals (CIs) were conducted, followed by sensitivity analyses, and the GRADE analysis of the evidence quality. A total of 24 papers (23 trials) were included, assessing preventive measures applied either around orthodontic brackets (21 trials; 1427 patients; mean age 14.4 years) or molar bands (2 trials; 46 patients; age/sex not reported). Active patient reminders were associated with reduced WSL incidence on patient level compared to no reminder (3 trials; 190 patients; RR: 0.4; 95% CI: 0.31-0.64; Number Needed to Treat [NNT]: 3 patients), flat surface sealants were associated with reduced WSL incidence on tooth level than no sealant (5 trials; 2784 teeth; RR: 0.8; 95% CI: 0.63-0.95; NNT: 33 teeth), and fluoride varnish was associated with reduced WSL severity on tooth level (2 trials; 1160 teeth; MD: -0.32 points; 95% CI: -0.44 to -0.21 points). However, the quality of evidence was low according to GRADE, due to risk of bias. Some evidence indicates that active patient reminders and flat surface sealants or fluoride varnish around orthodontic brackets might be associated with reduced WSL burden, but further research is needed. Keywords: adverse effects; clinical trials; dental caries; evidence-based medicine; fixed appliances; systematic review

Subcutaneously administered tirzepatide vs semaglutide for adults with type 2 diabetes: a systematic review and network meta-analysis of randomised controlled trials

Aims/hypothesis: We conducted a systematic review and network meta-analysis to compare the efficacy and safety of s.c. administered tirzepatide vs s.c. administered semaglutide for adults of both sexes with type 2 diabetes mellitus. Methods: We searched PubMed and Cochrane up to 11 November 2023 for RCTs with an intervention duration of at least 12 weeks assessing s.c. tirzepatide at maintenance doses of 5 mg, 10 mg or 15 mg once weekly, or s.c. semaglutide at maintenance doses of 0.5 mg, 1.0 mg or 2.0 mg once weekly, in adults with type 2 diabetes, regardless of background glucose-lowering treatment. Eligible trials compared any of the specified doses of tirzepatide and semaglutide against each other, placebo or other glucose-lowering drugs. Primary outcomes were changes in HbA1c and body weight from baseline. Secondary outcomes were achievement of HbA1c target of ≤48 mmol/mol (≤6.5%) or <53 mmol/mol (<7.0%), body weight loss of at least 10%, and safety outcomes including gastrointestinal adverse events and severe hypoglycaemia. We used version 2 of the Cochrane risk-of-bias tool (ROB 2) to assess the risk of bias, conducted frequentist random-effects network meta-analyses and evaluated confidence in effect estimates utilising the Confidence In Network Meta-Analysis (CINeMA) framework. Results: A total of 28 trials with 23,622 participants (44.2% female) were included. Compared with placebo, tirzepatide 15 mg was the most efficacious treatment in reducing HbA1c (mean difference −21.61 mmol/mol [−1.96%]) followed by tirzepatide 10 mg (−20.19 mmol/mol [−1.84%]), semaglutide 2.0 mg (−17.74 mmol/mol [−1.59%]), tirzepatide 5 mg (−17.60 mmol/mol [−1.60%]), semaglutide 1.0 mg (−15.25 mmol/mol [−1.39%]) and semaglutide 0.5 mg (−12.00 mmol/mol [−1.09%]). In between-drug comparisons, all tirzepatide doses were comparable with semaglutide 2.0 mg and superior to semaglutide 1.0 mg and 0.5 mg. Compared with placebo, tirzepatide was more efficacious than semaglutide for reducing body weight, with reductions ranging from 9.57 kg (tirzepatide 15 mg) to 5.27 kg (tirzepatide 5 mg). Semaglutide had a less pronounced effect, with reductions ranging from 4.97 kg (semaglutide 2.0 mg) to 2.52 kg (semaglutide 0.5 mg). In between-drug comparisons, tirzepatide 15 mg, 10 mg and 5 mg demonstrated greater efficacy than semaglutide 2.0 mg, 1.0 mg and 0.5 mg, respectively. Both drugs increased incidence of gastrointestinal adverse events compared with placebo, while neither tirzepatide nor semaglutide increased the risk of serious adverse events or severe hypoglycaemia. Conclusions/interpretation: Our data show that s.c. tirzepatide had a more pronounced effect on HbA1c and weight reduction compared with s.c. semaglutide in people with type 2 diabetes. Both drugs, particularly higher doses of tirzepatide, increased gastrointestinal adverse events. Registration: PROSPERO registration no. CRD42022382594 Graphical Abstract

Artificial pancreas treatment for outpatients with type 1 diabetes: systematic review and meta-analysis.

OBJECTIVE: To evaluate the efficacy and safety of artificial pancreas treatment in non-pregnant outpatients with type 1 diabetes. DESIGN: Systematic review and meta-analysis of randomised controlled trials. DATA SOURCES: Medline, Embase, Cochrane Library, and grey literature up to 2 February 2018. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised controlled trials in non-pregnant outpatients with type 1 diabetes that compared the use of any artificial pancreas system with any type of insulin based treatment. Primary outcome was proportion (%) of time that sensor glucose level was within the near normoglycaemic range (3.9-10 mmol/L). Secondary outcomes included proportion (%) of time that sensor glucose level was above 10 mmol/L or below 3.9 mmol/L, low blood glucose index overnight, mean sensor glucose level, total daily insulin needs, and glycated haemoglobin. The Cochrane Collaboration risk of bias tool was used to assess study quality. RESULTS: 40 studies (1027 participants with data for 44 comparisons) were included in the meta-analysis. 35 comparisons assessed a single hormone artificial pancreas system, whereas nine comparisons assessed a dual hormone system. Only nine studies were at low risk of bias. Proportion of time in the near normoglycaemic range (3.9-10.0 mmol/L) was significantly higher with artificial pancreas use, both overnight (weighted mean difference 15.15%, 95% confidence interval 12.21% to 18.09%) and over a 24 hour period (9.62%, 7.54% to 11.7%). Artificial pancreas systems had a favourable effect on the proportion of time with sensor glucose level above 10 mmol/L (-8.52%, -11.14% to -5.9%) or below 3.9 mmol/L (-1.49%, -1.86% to -1.11%) over 24 hours, compared with control treatment. Robustness of findings for the primary outcome was verified in sensitivity analyses, by including only trials at low risk of bias (11.64%, 9.1% to 14.18%) or trials under unsupervised, normal living conditions (10.42%, 8.63% to 12.2%). Results were consistent in a subgroup analysis both for single hormone and dual hormone artificial pancreas systems. CONCLUSIONS: Artificial pancreas systems are an efficacious and safe approach for treating outpatients with type 1 diabetes. The main limitations of current research evidence on artificial pancreas systems are related to inconsistency in outcome reporting, small sample size, and short follow-up duration of individual trials

Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD).

Glycemic management in type 2 diabetes mellitus has become increasingly complex and, to some extent, controversial, with a widening array of pharmacological agents now available (1–5), mounting concerns about their potential adverse effects and new uncertainties regarding the benefits of intensive glycemic control on macrovascular complications (6–9). Many clinicians are therefore perplexed as to the optimal strategies for their patients. As a consequence, the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) convened a joint task force to examine the evidence and develop recommendations for antihyperglycemic therapy in nonpregnant adults with type 2 diabetes. Several guideline documents have been developed by members of these two organizations (10) and by other societies and federations (2,11–15). However, an update was deemed necessary because of contemporary information on the benefits/risks of glycemic control, recent evidence concerning efficacy and safety of several new drug classes (16,17), the withdrawal/restriction of others, and increasing calls for a move toward more patient-centered care (18,19). This statement has been written incorporating the best available evidence and, where solid support does not exist, using the experience and insight of the writing group, incorporating an extensive review by additional experts (acknowledged below). The document refers to glycemic control; yet this clearly needs to be pursued within a multifactorial risk reduction framework. This stems from the fact that patients with type 2 diabetes are at increased risk of cardiovascular morbidity and mortality; the aggressive management of cardiovascular

A Cross-Sectional, Multicentric, Disease-Specific, Health-Related Quality of Life Study in Greek Transfusion Dependent Thalassemia Patients

The assessment of health-related quality of life (HRQoL) in thalassemia offers a holistic approach to the disease and facilitates better communication between physicians and patients. This study aimed to evaluate the HRQoL of transfusion-dependent thalassemia (TDT) patients in Greece. This was a multicentric, cross-sectional study conducted in 2017 involving 283 adult TDT patients. All participants completed a set of two QoL questionnaires, the generic SF-36v2 and the disease-specific TranQol. Demographic and clinical characteristics were used to predefine patient subgroups. Significant factors identified in the univariate analysis were entered into a multivariate analysis to assess their effect on HRQoL. The SF-36 scores of TDT patients were consistently lower compared to the general population in Greece. The mean summary score of TranQol was relatively high (71 ± 14%), exceeding levels observed in national surveys in other countries. Employment emerged as the most significant independent factor associated with better HRQoL, whereas age had the most significant negative effect. This study represents the first comprehensive QoL assessment of a representative sample of the TDT population in Greece. The implementation of TranQol allowed for the quantification of HRQoL in Greece, establishing a baseline for future follow-up, and identifying more vulnerable patient subgroups

The optimal second-line therapy for older adults with type 2 diabetes mellitus: protocol for a systematic review and network meta-analysis using individual participant data (IPD)

Background: Due to increasing life expectancy, almost half of people with type 2 diabetes are aged 65 years or over worldwide. When metformin alone does not control blood sugar, the choice of which second-line therapy to prescribe next is not clear from currently available evidence. The existence of frailty and comorbidities in older adults further increases the complexity of medical decision-making. As only a relatively small proportion of trials report results separately for older adults, the relative efficacy and safety of second-line therapies in older adults with type 2 diabetes mellitus are unknown and require further investigation. This individual participant data (IPD) network meta-analysis evaluates the relative efficacy and safety of second-line therapies on their own or in combination in older adults with type 2 diabetes mellitus. Methods: All relevant published and unpublished trials will be identified. Studies published prior to 2015 will be identified from two previous comprehensive aggregate data network meta-analyses. Searches will be conducted in CENTRAL, MEDLINE, and EMBASE from 1st January 2015 onwards, and in clinicaltrials.gov from inception. Randomised controlled trials with at least 100 estimated older adults (≥ 65 years) receiving at least 24 weeks of intervention that assess the effects of glucose-lowering drugs on mortality, glycemia, vascular and other comorbidities outcomes, and quality of life will be eligible. The screening and data extraction process will be conducted independently by two researchers. The quality of studies will be assessed using the Cochrane risk of bias tool 2. Anonymised IPD of all eligible trials will be requested via clinical trial portals or by contacting the principal investigators or sponsors. Received data will be reanalysed where necessary to standardise outcome metrics. Network meta-analyses will be performed to determine the relative effectiveness of therapies. Discussion: With the increasing number of older adults with type 2 diabetes worldwide, an IPD network meta-analysis using data from all eligible trials will provide new insights into the optimal choices of second-line antidiabetic drugs to improve patient management and reduce unnecessary adverse events and the subsequent risk of comorbidities in older adults. Systematic review registration: PROSPERO CRD42021272686

Hydrotherapy (Project Hydriades)

Natural resources are being used for the maintenance of health. According to the Law 3498/2006 of the Greek Parliament the natural health spas must be validated for their therapeutic properties. The Association of Municipalities and Communities of Health Springs of Greece signed a contract with the Research Committee of the Aristotle University of Thessaloniki, Greece, in order to conduct the research programme: ‘Study for the documentation of the therapeutic properties of the thermomineral waters’. The main aim of the project is: (1) the study of biological and therapeutic parameters of the natural health sources, (2) the identification of the indications and contraindications of hydrotherapy. Aims parallel to the main ones have been also set

Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial

Background: Glucagon-like peptide 1 receptor agonists differ in chemical structure, duration of action, and in their effects on clinical outcomes. The cardiovascular effects of once-weekly albiglutide in type 2 diabetes are unknown. We aimed to determine the safety and efficacy of albiglutide in preventing cardiovascular death, myocardial infarction, or stroke. Methods: We did a double-blind, randomised, placebo-controlled trial in 610 sites across 28 countries. We randomly assigned patients aged 40 years and older with type 2 diabetes and cardiovascular disease (at a 1:1 ratio) to groups that either received a subcutaneous injection of albiglutide (30–50 mg, based on glycaemic response and tolerability) or of a matched volume of placebo once a week, in addition to their standard care. Investigators used an interactive voice or web response system to obtain treatment assignment, and patients and all study investigators were masked to their treatment allocation. We hypothesised that albiglutide would be non-inferior to placebo for the primary outcome of the first occurrence of cardiovascular death, myocardial infarction, or stroke, which was assessed in the intention-to-treat population. If non-inferiority was confirmed by an upper limit of the 95% CI for a hazard ratio of less than 1·30, closed testing for superiority was prespecified. This study is registered with ClinicalTrials.gov, number NCT02465515. Findings: Patients were screened between July 1, 2015, and Nov 24, 2016. 10 793 patients were screened and 9463 participants were enrolled and randomly assigned to groups: 4731 patients were assigned to receive albiglutide and 4732 patients to receive placebo. On Nov 8, 2017, it was determined that 611 primary endpoints and a median follow-up of at least 1·5 years had accrued, and participants returned for a final visit and discontinuation from study treatment; the last patient visit was on March 12, 2018. These 9463 patients, the intention-to-treat population, were evaluated for a median duration of 1·6 years and were assessed for the primary outcome. The primary composite outcome occurred in 338 (7%) of 4731 patients at an incidence rate of 4·6 events per 100 person-years in the albiglutide group and in 428 (9%) of 4732 patients at an incidence rate of 5·9 events per 100 person-years in the placebo group (hazard ratio 0·78, 95% CI 0·68–0·90), which indicated that albiglutide was superior to placebo (p&lt;0·0001 for non-inferiority; p=0·0006 for superiority). The incidence of acute pancreatitis (ten patients in the albiglutide group and seven patients in the placebo group), pancreatic cancer (six patients in the albiglutide group and five patients in the placebo group), medullary thyroid carcinoma (zero patients in both groups), and other serious adverse events did not differ between the two groups. There were three (&lt;1%) deaths in the placebo group that were assessed by investigators, who were masked to study drug assignment, to be treatment-related and two (&lt;1%) deaths in the albiglutide group. Interpretation: In patients with type 2 diabetes and cardiovascular disease, albiglutide was superior to placebo with respect to major adverse cardiovascular events. Evidence-based glucagon-like peptide 1 receptor agonists should therefore be considered as part of a comprehensive strategy to reduce the risk of cardiovascular events in patients with type 2 diabetes. Funding: GlaxoSmithKline