Semir Nouira

Background: The aim of this study was to investigate the effect of Ramadan fasting (RF) on markers of endothelial function and metabolic parameters in patients with type 2 diabetes mellitus (T2DM) and healthy controls. Methods: This cohort study involved 305 subjects: 167 T2DM and 138 healthy volunteers subjects. The following parameters were evaluated: body mass index (BMI), diet inflammatory index (DII), serum glucose and lipid profile and high-sensitivity C-reactive protein (hs-CRP) during three separate visits, before Ramadan (baseline), the last week of Ramadan, and during the last week of the month following Ramadan. In each visit, reactive hyperaemia index (RHI) in all participants was assessed. In diabetic patients, serum homocyteine (Hcys) was mesured at baseline and during RF. The primary endpoint was change in RHI, a validated and non-invasive measure of endothelial function. The secondary end point was change in clinical, metabolic parameters, and Hcys. Analyses used non-parametric tests and multivariable regression with multiple imputation. Results: RF significantly decreased RHI [−0.2 UI (95% CI −0.3 to −0.09); p < 0.001] and increased serum homocysteine [1.2 µmol/L (95% CI 0.7–1.8); p < 0.001] in T2DM compared to baseline levels.RF did not significantly change RHI in healthy volunteers. A significant increase in blood glucose ( p < 0.001) and LDL cholesterol ( p = 0.003) was observed during Ramadan compared to baseline, whereas HDL cholesterol, DII, and BMI decreased. Among healthy volunteers, similar changes in metabolic parameters were observed, with hs-CRP increasing during Ramadan compared to baseline ( p = 0.01). Conclusion: RF seems to be associated with unfavorable effects on endothelial function in diabetic patients but not in healthy subjects. RHI testing could help identifying diabetic patients who should not observe RF or should be closely monitored during fasting.

Objective: To compare three therapeutic strategies in the management of acute post-traumatic pain at emergency department (ED) discharge. Methods: We conducted a prospective, randomized, controlled trial including patients ≥18 years with acute post-traumatic pain. They were randomized to receive oral paracetamol (n = 506), paracetamol-codeine (P-Cod group; n = 489) and paracetamol-caffeine (P-Caf group; n = 505) for 7 days. The primary endpoint was the rate of participants achieving at least 50% reduction in Numerical Rating Scale (NRS) from baseline by the 7th day after ED discharge. Secondary endpoints included the need for rescue analgesics, adverse effects, and patient satisfaction. Results: At day-7, success rate were 85.8%, 93.9%, and 90.1% in paracetamol, P-Cod, and P-Caf groups, respectively. The differences were statistically significant between the paracetamol and P-Caf groups (p = .02), the paracetamol and P-Cod groups ( p ≤ .001); and the P-Cod and P-Caf groups ( p = .04). The need for rescue analgesics was significantly higher in paracetamol group (47.6%) compared to P-Caf (7.5%) and P-Cod group (7.4%); whereas, no significant difference was found between P-Cod and P-Caf groups. Most of the adverse effects (95.7%) were observed in P-Cod group. Finally, patients treated with paracetamol alone were the least satisfied. Conclusion: The combination of codeine or caffeine with paracetamol was equally effective and superior to paracetamol alone. If we consider the better tolerance, paracetamol combined with caffeine appears to be a suitable analgesic option for post trauma patients.

The Horoscope trial aimed to assess the efficacy of home blood pressure (BP) telemonitoring (TLM) in controlling BP reduction in hypertensive patients compared with usual care. This is a multi-center, prospective randomized, parallel-group trial comparing TLM with usual care during a period of 6 months in patients with hypertension. We included 525 patients randomly assigned in a 1-1 ratio to telemonitoring (TLM group; n = 260) or usual care (control group; n = 265). After 6 months of follow up, mean values of 24-h systolic and diastolic blood pressure decreased in both TLM and control groups. The mean decrease was significantly greater in the TLM group vs control group (−3.29 mmHg Vs −1.19; p = 0.009) and (−2.9 mmHg Vs, −0.07; p = 0.002) for systolic and diastolic blood pressure, respectively. This study shows that TLM results in significant BP reduction compared to usual care in a Tunisian population of patients with hypertension. Our findings highlight the importance of integrating telemedicine in the management of hypertensive patients; it has the potential to improve the quality of the delivered care and to prevent cardiovascular consequences of uncontrolled BP.

Background: Emergency medicine is particularly well suited to simulation training. However, evidence for the efficacy of simulation-based medical training remains limited especially to manage high-risk cases such as acute asthma. Objective: The objective of our study was to compare the performance of high-fidelity simulation (HFS) and interactive video-case challenge-based training (IVC) for final-year medical students in the management of acute asthma. Methods: This was a prospective randomized controlled study conducted at the emergency department (ED) of Monastir University hospital ( Tunisia). 69 final-year medical students were randomized to HFS (n = 34) and IVC (n = 35) training on acute asthma topic. The study was conducted over a 1-week period. Efficacy of each teaching method was compared through the use of multiple-choice questionnaires (MCQ) before (pre-test), after (post-test) training and a simulation scenario test conducted 1 week later. The scenario was based on acute asthma management graded on predefined critical actions using two scores: the checklist clinical score (range 0 to 30), and the team skills score (range 0 to 16). Student satisfaction was also evaluated with the Likert 5 points scale. Two years after the post-test, both groups underwent a third MCQ testing to assess sustainability of knowledge. Results: There were no differences in age between groups. There was no statistically significant difference between the HFS and IVC groups pre-test scores (p = 0.07). Both groups demonstrated improvement in MCQ post-test from baseline after training session; the HFS MCQ post-test score increased significantly more than the IVC score (p < 0.001). The HFS group performed better than the IVC group on the acute asthma simulation scenario (p < 0.001). Mean checklist clinical score and mean team skills score were significantly higher in HFS group compared to IVC group (respectively 22.9 ± 4.8 and 11.5 ± 2.5 in HFS group vs 19.1 ± 3 and 8.4 ± 3.1 in IVC group) (p < 0.001). After 2 years, MCQ post-test scores decreased in both groups but the decrease was lower in HFS group compared to the IVC group. Conclusion: High-fidelity simulation-based training was superior to interactive video-case challenge for teaching final year medical students,and led to more long-term knowledge retention in the management of simulated acute asthma patients. Trial registration: The study was registered at www.clinicaltrials.gov NCT02776358 on 18/05/2016.

Estimating mortality risk in hospitalized patients with COVID-19 infection may help clinicians to early triage patients with poor prognostic outcome. The Coronavirus Clinical Characterization Consortium Mortality Score (4C Score) is one of the predictive models that was externally validated in large cohorts. However, its use may be limited in population with quite different demographic and epidemiologic features. Objective To externally validate the 4 C score in a large Tunisian population Methods Multicenter retrospective cohort study of patients aged ≥ 14 years, hospitalized with the diagnosis of COVID-19. The primary outcome was in-hospital mortality, need for ICU admission and combined outcome (in-hospital mortality and/or ICU admission). We calculated the area under the receiver operating characteristic (ROC) curve (C statistics) for the 4C Mortality Score to assess the discriminatory power of the 4C Mortality Score for predicting outcomes. To assess calibration of the model, we used the Hosmer-Lemeshow goodness-of-fit test. Results 2327 patients with diagnosis of COVID-19 based on positive RT-PCR assay or rapid antigen test of a nasopharyngeal swab were included for final analysis. Median time between symptoms start and hospital admission was 4 days [2-7], and 69.2% needed oxygen therapy at hospital admission. In-hospital mortality was 15.4% (n=358); most deaths (11%, n=257) occurred in the ICU. Mortality rates within the 4C Mortality Score risk groups were 0.6% (Low), 8.7% (Intermediate), 53.1% (High), and 37.7% (Very High). The score achieved a good estimated discrimination when predicting death (C-statistic:0.86; 95%, CI [0.84-0.88]), ICU admission (C-statistic: 0.69; 95%, CI [0.65-0.72]) and the combined outcome (C-statistic:0.79; 95%, CI [0.77-0.81]). The calibration plot indicated good calibration for both in-hospial mortality and combined outcome (HosmerLemeshow goodness-of-fit test p value of 0.86 and 0.28 respectively). Our study represents a new external validation of the 4C score in COVID-19 patients with high reliability in predicting disease severity. These findings imply that the 4C Mortality Score may be generalized to patients with COVID-19 regardless of ethnicity and healthcare system.

Objective: To determine the impact of mobile-phone telemonitoring on patients’ adherence and satisfaction with posttrauma pain treatment. Materials and Methods: We conducted a prospective randomized clinical trial including patients with minor trauma discharged from the emergency department (ED) with analgesic treatment. Patients were randomized to one of 3 groups, the control group, where patients received a phone call on day-7, the short message service (SMS) group, where patients received a daily text message to remind them to take their treatment during 7 days, and the mobile-phone based telemonitoring (TLM) group. Patients’ adherence to analgesic treatments using the Morisky Medication Adherence Scale, current pain by using a visual analogue scale, and patients’ satisfaction were assessed. For the TLM group, the assessment was performed at day-2, 4 and 7. Results: Good adherence was observed in 418 patients (92.9%) in the TLM group versus 398 patients (88.6%) in the SMS group and 380 patients (84.8%) in the control group (PPP=0.02). Discussion: Our findings suggest that mobile-phone–based telemonitoring is beneficial in the treatment of pain in trauma patients after ED discharge. This approach improved patients’ adherence and satisfaction.