Magnesium Sulfate Versus Lidocaine as an Adjunct for Renal Colic in the Emergency Department: A Randomized, Double-Blind Controlled Trial.

STUDY OBJECTIVE: We wished to determine whether the addition of magnesium sulfate (MgSO4) or lidocaine to diclofenac could improve the analgesic efficacy in emergency department (ED) patients with acute renal colic. METHODS: In this prospective, double-blinded, randomized controlled trial of patients aged 18 to 65 years with suspected acute renal colic, we randomized them to receive 75 mg intramuscular (IM) diclofenac and then intravenous (IV) MgSO4, lidocaine, or saline solution control. Subjects reported their pain using a numerical rating scale (NRS) before drug administration and then 5, 10, 20, 30, 60, and 90 minutes afterwards. Our primary outcome was the proportion of participants achieving at least a 50% reduction in the NRS score 30 minutes after drug administration. RESULTS: We enrolled 280 patients in each group. A 50% or greater reduction in the NRS score at 30 minutes occurred in 227 (81.7%) patients in the MgSO4 group, 204 (72.9%) in the lidocaine group, and 201 (71.8%) in the control group, with significant differences between MgSO4 and lidocaine (8.8%, 95% confidence interval [CI] [1.89 to 15.7], P=.013) and between MgSO4 and control (9.9%, 95% CI [2.95 to 16.84], P=.004). Despite this, differences between all groups at every time point were below the accepted 1.3 threshold for clinical importance. There were no observed differences between groups in the frequency of rescue analgesics and return visits to the ED for renal colic. There were more adverse events, although minor, in the MgSO4 group. CONCLUSION: Adding intravenous MgSO4, but not lidocaine, to IM diclofenac offered superior pain relief but at levels below accepted thresholds for clinical importance.

Melatonin, vitamins and minerals supplements for the treatment of Covid-19 and Covid-like illness: A prospective, randomized, double-blind multicenter study.

BACKGROUND: Melatonin, zinc, and multivitamins are among most recommended supplements in the fight against coronavirus disease 2019 (COVID-19). We aimed to examine the efficacy and safety of this association in the treatment of COVID-19 and COVID-like illnesses. METHODS: We conducted a multicenter prospective, randomized, double-blind, controlled trial. Patients with no medical history consulting the emergency department for covid and covid-like illness and who were not hospitalized were included. Patients were assigned in a 1:1 ratio to the treatment or the placebo group. The primary outcome was studying the effectiveness of zinc multivitamin supplement and melatonin in the treatment of COVID and -like illnesses symptoms' according to the time from randomization to clinical improvement. The pre-specified secondary outcomes were date of disappearance of symptoms present on admission, appearance of an adverse effect due to the administration of the treatment, number of patients developing complications, requiring hospitalization, requiring respiratory support. RESULTS: One hundred sixty four patients were eligible for the study and were randomized to either the treatment group or the placebo group. Overall, 128 of the 164 patients had a PCR for SARS-CoV-2, yielding a positive PCR result in 49.1% of them. Regarding the disappearance of all initial presenting symptoms: on the 5th day of the follow-up, there was a significant difference between the two groups with a p value 0.04;On the 10th day, there was a significant difference too with p value of 0.038. There were no significant differences between the two groups in recovery during the 15th day of follow-up p>0.5. Finally, 100% of patients fully recovered in the treatment group vs 98.8% in the placebo group. No severe adverse events were reported throughout the trial. CONCLUSIONS: Our results showed that daily doses of Melatonin, zinc and vitamins did significantly reduce the duration of symptoms accelerating its disappearance among patients consulting with COVID-19 or COVID-19 like illness.

Comparison of simulation and video-based training for acute asthma.

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.

Value of inferior vena cava collapsibility index as marker of heart failure in chronic obstructive pulmonary disease exacerbation.

INTRODUCTION: Inferior vena cava (IVC) diameter variability with respiration measured by ultrasound was found to be useful for the diagnosis of heart failure (HF) in ED patients with acute dyspnea. Its value in identifying HF in acute exacerbation of chronic obstructive pulmonary disease exacerbation (AECOPD) was not specifically demonstrated. OBJECTIVE: To determine the value of ΔIVC in the diagnosis of HF patients with AECOPD. METHODS: This is a prospective study conducted in the ED of three Tunisian university hospitals including patients with AECOPD. During this period, 401 patients met the inclusion criteria. The final diagnosis of HF is based on the opinion of two emergency experts after consulting the data from clinical examination, cardiac echocardiography, and BNP level. The ΔIVC was calculated by two experienced emergency physicians who were blinded from the patient's clinical and laboratory data. A cut off of 15% was used to define the presence (< 15%) or absence of HF (≥ 15%). Left ventricular ejection fraction (LVEF) was also measured. The area under the ROC curve, sensitivity, specificity, and positive and negative predictive values were calculated to determine the diagnostic and predictive accuracy of the ΔIVC in predicting HF. RESULTS: The study population included 401 patients with AECOPD, mean age 67.2 years with male (68.9%) predominance. HF was diagnosed in 165 (41.1%) patients (HF group) and in 236 patients (58.9%) HF was excluded (non HF group). The assessment of the performance of the ΔIVC in the diagnosis of HF showed a sensitivity of 37.4% and a specificity of 89.7% using the threshold of 15%. The positive predictive value was 70.9% and the negative predictive value was 66.7%. The area under the ROC curve was 0.71(95%, CI 0.65-0.76). ΔIVC values were not different between HF patients with reduced LVEF and those with preserved LVEF. CONCLUSION: Our results showed that ΔIVC has a good value for ruling out HF in ED patients consulting for AECOPD.

Mobile Phone-Based Telemonitoring for Improving Adherence to Analgesic Treatment in Trauma Patients After Emergency Department Discharge: A Randomized Controlled Trial.

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 ( P <0.001). The factor mostly associated with adherence was telemonitoring (OR 2.40 95% CI 1.55-3.71). The decrease in pain visual analogue scale was highest in the TLM group compared with SMS and control groups ( P <0.001). The percentage of patients' satisfaction at 7 days post-ED discharge was 93% in the TLM group versus 88% in the SMS group and 84% in the standard group ( P =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.

Pulse amplitude ratio under noninvasive ventilation as a new method in the diagnosis of left heart failure in patients with acute exacerbation of chronic obstructive pulmonary disease.

BACKGROUND: Left heart failure (LHF) is commonly associated with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) but its role is often underestimated. AIM OF STUDY: To evaluate the performance of a new diagnostic technique based on the measurement of the pulse amplitude ratio (PAR) using non-invasive ventilation (NIV) for the early identification LHF in patients admitted to the emergency department (ED) for AECOPD. RESULTS: 73 patients were included in this study: 32 in LHF group and 41 in non LHF- group. The two groups had comparable demographic and clinical characteristics at admission. The mean values of PARNIV was significantly higher among LHF patients (0.86 vs. 0.71; p < 0.01). The area under the receiver operating characteristic curve of PARNIV was 0.75. Using the best cut-off (0.6), the sensitivity of PARNIV was 93% with a specificity 21%, a positive predictive value of 48%, and a negative predictive value of 81%. Correlation between PARNIV and BNP was significant (r = 0.52; p = 0.002). CONCLUSION: Measurement of PARNIV in patients presenting to the ED with AECOPD had a good diagnostic performance for the detection of LHF and could represent an interesting alternative for the currently available methods. Trial registration The study was registered in the Clinical Trial Registration System (clinicaltrials.gov) under the study number NCT05189119, https://register. CLINICALTRIALS: gov/prs/app/action/SelectProtocol?sid=S000BOO4&selectaction=Edit&uid=U0000QAM&ts=2&cx=qrmluh .

External validations of the ABCD2 score in prediction of stroke risk after transient ischemic attack. A Tunisian hospital-based cohort study.

BACKGROUND AND PURPOSE: Identification of patients with high risk of stroke after transient ischemic attack (TIA) could be helpful to optimize stroke prevention. We aimed to externally validate the ABCD2 score for the prediction of stroke after TIA in a Tunisian population. METHODS: We conducted a retrospective observational study of consecutive patients admitted for TIA in four university hospitals in Tunisia. Patients were screened for onset of stroke. Sensitivity, specificity, positive and negative predictive values with areas under the receiver operating characteristic (ROC) curves were calculated for risk of stroke at 2, 7, 30 and 90 days after the index event. RESULTS: Of 415 patients screened in this study, the total cumulative subsequent stroke rates after TIA at 2, 7, 30 and 90 days were respectively, 4.8%, 10.6%, 13.5% and 20.2%. Using a cut-off value of 4, the ABCD2 showed an overall good sensitivity (95%, 97.7%, 96.4% and 97.6% respectively at 2, 7, 30 and 90 days). Areas under ROC cure of the ABCD2 score in patients with TIA for stroke onset at 2, 7, 30 and 90 days were respectively 0.67 (95% CI, 0.55-0.79), 0.79 (95% CI, 0.71-0.85), 0.79 (95% CI, 0.72-0.85), and 0.76 (95% CI, 0.70-0.81). CONCLUSION: Our findings suggest that the ABCD2 score could be used in our population to discriminate patient with TIA at low and high risk of developing recurrent stroke.

Twice-Daily Oral Zinc in the Treatment of Patients With Coronavirus Disease 2019: A Randomized Double-Blind Controlled Trial.

BACKGROUND: Zinc supplementation has been considered a potential therapy for coronavirus disease 2019 (COVID-19). We aimed to examine zinc efficacy in adult patients with COVID-19 infection. METHODS: We conducted a prospective, randomized, double-blind, placebo-controlled multicenter trial. Patients who were tested positive for COVID-19 without end-organ failure were randomized to oral zinc (n = 231) or matching placebo (n = 239) for 15 days. The primary combined outcome was death due to COVID-19 or intensive care unit (ICU) admission ≤30 days after randomization. Secondary outcomes included length of hospital stay for inpatients and duration of COVID-19 symptoms with COVID-19-related hospitalization for outpatients. RESULTS: 190 patients (40.4%) were ambulatory and 280 patients (59.6%) were hospitalized. Mortality at 30 days was 6.5% in the zinc group and 9.2% in the placebo group (OR: .68; 95% CI .34-1.35); ICU admission rates were, respectively, 5.2% and 11.3% (OR: .43; 95% CI .21-.87). Combined outcome was lower in the zinc group versus the placebo group (OR: .58; 95% CI .33-.99). Consistent results were observed in prespecified subgroups of patients aged <65 years, those with comorbidity, and those who needed oxygen therapy at baseline. Length of hospital stay was shorter in the zinc group versus the placebo group (difference: 3.5 days; 95% CI 2.76-4.23) in the inpatient group; duration of COVID-19 symptoms decreased with zinc treatment versus placebo in outpatients (difference: 1.9 days; 95% CI .62-2.6). No severe adverse events were observed during the study. CONCLUSIONS: Our results showed that, in COVID-19 patients, oral zinc can decrease 30-day death, ICU admission rate and can shorten symptom duration. Clinical Trials Registration. ClinicalTrials.gov, NCT05212480.

Analgesic Effect of Topical Piroxicam vs Phytotherapy Gel in the Treatment of Acute Soft Tissue Injuries: A Randomized Controlled Noninferiority Study.

OBJECTIVE: The study compared the efficacy and tolerability of piroxicam gel and a new topical combination of medicinal plant products (Soulagel®; Belpharma Tunisia) to treat pain caused by soft tissue injuries. METHODS: Patients (n = 1,525) were assigned to receive piroxicam gel or Soulagel. Efficacy assessments included a change of at least 50% in the pain-on-movement visual numeric scale rating from emergency department discharge (baseline) to day 7 final assessment, as well as the time required to reach pain resolution criteria, the need for rescue analgesia, patients' satisfaction, and the rate of adverse effects. RESULTS: At day 7, 1,216 patients (79.7%) achieved at least 50% reduction in visual numeric scale rating from baseline: 623 patients (82.4%) in the Soulagel group vs 593 patients (77.1%) in the piroxicam group (P = 0.01). Time to decrease pain on movement by 50% was significantly higher with piroxicam gel than with Soulagel (34 ± 1 vs 33 ± 1 days, respectively; P = 0.54). At day 7, 96.4% of patients in the Soulagel group declared being "very satisfied" to "satisfied," vs 68% in the piroxicam group (P < 0.001). There were no major adverse events in either group. CONCLUSIONS: Soulagel is not inferior to piroxicam gel for managing pain related to a soft tissue injuries. Further studies will help ascertain whether this new gel offers an alternative treatment option for this common emergency department condition.

Appropriateness of antibiotic treatment of acute respiratory tract infections in Tunisian primary care and emergency departments: a multicenter cross-sectional study.

BACKGROUND: Little is known about the pattern and appropriateness of antibiotic prescriptions in patients with acute respiratory tract infections (ARTIs). OBJECTIVE: Describe the antibiotics used to treat ARTIs in Tunisian primary care offices and emergency departments (EDs), and assess the appropriateness of their use. METHODS: It was a prospective multicenter cross-sectional observational clinical study conducted at 63 primary care offices and 6 EDS during a period of 8 months. Appropriateness of antibiotic prescription was evaluated by trained physicians using the medication appropriateness index (MAI). The MAI ratings generated a weighted score of 0 to 18 with higher scores indicating low appropriateness. The study was conducted in accordance with the Declaration of Helsinki and national and institutional standards. The study was approved by the Ethics committee of Monastir Medical Faculty. RESULTS: From the 12,880 patients screened we included 9886 patients. The mean age was 47.4, and 55.4% were men. The most frequent diagnosis of ARTI was were acute bronchitis (45.3%), COPD exacerbation (16.3%), tonsillitis (14.6%), rhinopharyngitis (12.2%) and sinusitis (11.5%). The most prescribed classes of antibiotics were penicillins (58.3%), fluoroquinolones (17.6%), and macrolides (16.9%). Antibiotic therapy was inappropriate in 75.5% of patients of whom 65.2% had bronchitis. 65% of patients had one or more antibiotic prescribing inappropriateness criteria as assessed by the MAI. The most frequently rated criteria were with expensiveness (75.8%) and indication (40%). Amoxicillin-clavulanic acid and levofloxacin were the most inappropriately prescribed antibiotics. History of cardiac ischemia ([OR] 3.66; 95% [CI] 2.17-10.26; p < 0.001), asthma ([OR] 3.29, 95% [CI] 1.77-6.13; p < 0.001), diabetes ([OR] 2.09, 95% [CI] 1.54-2.97; p = 0.003), history of COPD ([OR] 1.75, 95% [CI] 1.43-2.15; p < 0.001) and age > 65 years (Odds Ratio [OR] 1.35, 95% confidence interval [CI] 1.16-1.58; p < 0.001) were associated with a higher likelihood of inappropriate prescribing. CONCLUSION: Our findings indicate a high inappropriate use of antibiotics in ARTIs treated in in primary care and EDs. This was mostly related to antibiotic prescription in acute bronchitis and overuse of expensive broad spectrum antibiotics. Future interventions to improve antibiotic prescribing in primary care and EDs is needed. TRIAL REGISTRATION: the trial is registered at Clinicaltrials.gov registry (NCT04482231).

Two-day versus seven-day course of levofloxacin in acute COPD exacerbation: a randomized controlled trial.

INTRODUCTION: Duration of antibiotic treatment in acute exacerbation of COPD (AECOPD) is most commonly based on expert opinion. Typical administration periods range from 5 to 7 days. A 2-day course with levofloxacin was not previously assessed. We performed a randomized clinical trial to evaluate the efficacy of 2-day versus 7-day treatment with levofloxacin in patients with AECOPD. METHODS AND ANALYSIS: Patients with AECOPD were randomized to receive levofloxacin for 2 days and 5 days placebo (n = 155) or levofloxacin for 7 days (n = 155). All patients received a common dose of intravenous prednisone daily for 5 days. The primary outcome measure was cure rate, and secondary outcomes included need for additional antibiotics, ICU admission rate, re-exacerbation rate, death rate, and exacerbation-free interval (EFI) within 1-year follow-up. The study protocol has been prepared in accordance with the revised Helsinki Declaration for Biomedical Research Involving Human Subjects and Guidelines for Good Clinical Practice. The study was approved by ethics committees of all participating centers prior to implementation (Monastir and Sousse Universities). RESULTS: 310 patients were randomized to receive 2-day course of levofloxacin (n = 155) or 7-day course (n = 155). Cure rate was 79.3% (n = 123) and 74.2% (n = 115), respectively, in 2-day and 7-day groups [OR 1.3; 95% CI 0.78-2.2 (p = 0.28)]. Need for additional antibiotics rate was 3.2% and 1.9% in the 2-day group and 7-day group, respectively; (p = 0.43). ICU admission rate was not significantly different between both groups. One-year re-exacerbation rate was 34.8% (n = 54) in 2-day group versus 29% (n = 45) in 7-day group (p = 0.19); the EFI was 121 days (interquartile range, 99-149) versus 110 days (interquartile range, 89-132) in 2-day and 7-day treatment groups, respectively; (p = 0.73). One-year death rate was not significantly different between the 2 groups, 5.2% versus 7.1% in the 2-day group and 7-day group, respectively; (p = 0.26). No difference in adverse effects was detected. CONCLUSION: Levofloxacin once daily for 2 days is not inferior to 7 days with respect to cure rate, need for additional antibiotics and hospital readmission in AECOPD. Our findings would improve patient compliance and reduce the incidence of bacterial resistance and adverse effects.

Home Telemonitoring of Arterial Hypertension With Antihypertensive Treatment Titration: Protocol for a Randomized Controlled Prospective Trial (HOROSCOPE Study).

BACKGROUND: Despite the availability of effective treatment, the control of hypertension remains insufficient. Telemonitoring in the management of hypertension would be an effective way to improve blood pressure control. OBJECTIVE: The aim of our study will be to evaluate the effects of telemonitoring with antihypertensive treatment titration on blood pressure control in Tunisian patients with hypertension. METHODS: Our trial will be a prospective, rater-blinded randomized controlled trial carried out with primary care physicians in the Sahel region of Tunisia. Patients will be eligible for enrollment if they are aged over 35 years, are newly diagnosed with hypertension, or are known to be poorly controlled on antihypertensive therapy. Participants will be randomly assigned in a 1:1 ratio to the telemonitoring arm or usual care arm. The telemonitoring arm will involve a weekly telephone call for the collection of the home blood pressure measurements, therapeutic education, and treatment compliance assessment as well as a monthly call for treatment titration and a side effect check. Randomization will be done via the use of an interactive web responsive system, and patients will be stratified by investigation center. Neither participants nor investigators will be masked to the group assignments. The primary outcome will be the change in mean 24-hour systolic blood pressure from baseline to the 6-month follow-up in the 2 groups. All randomized patients who attend the follow-up visit at 6 months and have no missing data for the primary outcome will be included in the analysis. RESULTS: Recruitment to the trial started in July 2020. The study was initiated with 17 primary care physicians. We expect the inclusion period to last for approximately 6 months. We expect to complete data collection by the end of 2021 and plan to disseminate the results subsequently. CONCLUSIONS: The HOROSCOPE (Home Telemonitoring of Arterial Hypertension With Antihypertensive Treatment Titration: Randomized Controlled Prospective Trial) study will provide important new evidence that could shed some light on the feasibility and impact of telemonitoring and self-monitoring in a Tunisian population of patients with hypertension who consult primary care physicians. TRIAL REGISTRATION: ClinicalTrials.gov NCT04607239; https://clinicaltrials.gov/ct2/show/NCT04607239. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/26184.

30 day predicted outcome in undifferentiated chest pain: multicenter validation of the HEART score in Tunisian population.

BACKGROUND: Chest pain remains one of the most challenging serious complaints in the emergency department (ED). A prompt and accurate risk stratification tool for chest pain patients is paramount to help physcian effectively progrnosticate outcomes. HEART score is considered one of the best scores for chest pain risk stratification. However, most validation studies of HEART score were not performed in populations different from those included in the original one. OBJECTIVE: To validate HEART score as a prognostication tool, among Tunisian ED patients with undifferentiated chest pain. METHODS: Our prospective, multicenter study enrolled adult patients presenting with chest pain at chest pain units. Patients over 30 years of age with a primary complaint of chest pain were enrolled. HEART score was calculated for every patient. The primary outcome was major cardiovascular events (MACE) occurrence, including all-cause mortality, non-fatal myocardial infarction (MI), and coronary revascularisation over 30 days following the ED visit. The discriminative power of HEART score was evaluated by the area under the ROC curve. A calibration analysis of the HEART score in this population was performed using Hosmer-Lemeshow goodness of test. RESULTS: We enrolled 3880 patients (age 56.3; 59.5% males). The application of HEART score showed that most patients were in intermediate risk category (55.3%). Within 30 days of ED visit, MACE were reported in 628 (16.2%) patients, with an incidence of 1.2% in the low risk group, 10.8% in the intermediate risk group and 62.4% in the high risk group. The area under receiver operating characteristic curve was 0.87 (95% CI 0.85-0.88). HEART score was not well calibrated (χ2 statistic = 12.34; p = 0.03). CONCLUSION: HEART score showed a good discrimination performance in predicting MACE occurrence at 30 days for Tunisian patients with undifferentiated acute chest pain. Heart score was not well calibrated in our population.