1. In a trial of patients undergoing a laparoscopic inguinal hernia repair, an intraoperative urinary catheter did not reduce the risk of postoperative urinary retention.
Evidence Rating Level: 1 (Excellent)
One of the most common complications following a laparoscopic inguinal hernia repair is postoperative urinary retention (PUR). In clinical practice, intraoperative catheters are often used due to presumed protection against this complication. However, there is a lack of studies evaluating the validity of this presumption. Therefore, this randomized clinical trial sought to evaluate the effects of an intraoperative catheter on PUR after a laparoscopic inguinal hernia repair. It enrolled 491 patients (median [IQR] age, 61 [51-68] years; 465 [94.7%] male) undergoing surgery from various community hospitals in the United States. 241 patients were randomized to the intervention group where a urinary catheter was placed after induction of anesthesia and removed before the end of procedure. 250 patients were randomized to the control group who had no catheter placement. There were no significant differences in patient demographics between the two groups including various comorbidities. The primary outcome was PUR, defined as inability to void urine requiring straight catheterization, placement of an indwelling catheter, or return to the emergency department up to 30 days postoperatively. The study found that there was no difference in the PUR rate between the intervention and control groups (23 patients [9.6%] vs 21 patients [8.5%], respectively, P = .79). There was also no difference in the timing of PUR diagnosis and treatment between the 2 groups. The secondary outcomes measured were bladder injuries, urinary tract infections, and urinary tract injuries at the time of the procedure or postoperatively. There was no statistically significant difference between the two groups for the secondary outcomes. Overall, this study concluded that urinary catheters did not reduce the risk of PUR after laparoscopic inguinal hernia repairs and therefore, their use should be reevaluated. More, larger-scale trials are needed to further support their conclusions.
1. In a trial of patients with atrial fibrillation and stable coronary artery disease, monotherapy with rivaroxaban is associated with lower risks of total thrombotic and/or bleeding events than combination therapy.
Evidence Rating Level: 1 (Excellent)
Atrial fibrillation is a complex and common condition with high morbidity. As such, identifying optimal antithrombotic therapy in patients with atrial fibrillation, especially those with comorbid coronary artery disease (CAD), is important. Therefore, this analysis of a randomized clinical trial sought to determine whether anticoagulant therapy alone, compared with combination anticoagulant and antiplatelet therapy, was associated with a lower incidence of total cardiovascular and/or bleeding events. It analyzed data from 2215 enrolled patients (mean [SD] age, 74 [8.2] years; 1751 men [79.1%]; 464 women [20.9%]). 1107 patients were in the monotherapy group and received 10 mg (patients with creatinine clearance of 15 to 49 mL/min) or 15 mg (patients with creatinine clearance of ≥50 mL/min) of rivaroxaban once daily. 1108 patients were in the combination therapy group, receiving rivaroxaban and an antiplatelet agent (aspirin or P2Y12 inhibitor according to discretion of treating physician). The primary outcome measured was total number of first and subsequent events, including death, bleeding (hemorrhagic stroke or major bleeding), and thrombotic events (ischemic stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, or death from any cause). The total event rate for the rivaroxaban monotherapy group was 12.2% (135 of 1107) and for the combination-therapy group was 19.2% (213 of 1108). It found that monotherapy demonstrated lower rates than combination therapy for the first and subsequent events by 31% (rate ratio, 0.69; 95% CI, 0.55-0.87) and 54% (rate ratio, 0.46; 95% CI, 0.29-0.74), respectively. Monotherapy was also associated with a 38% lower cumulative hazard of total events, including death from any cause, systemic embolism, unstable angina requiring revascularization, myocardial infarction, hemorrhagic and ischemic stroke, and major bleeding, than combination therapy (hazard ratio [HR], 0.62; 95% CI, 0.48-0.80; P < .001). Therefore, the study concluded that monotherapy with rivaroxaban was associated with lower risks of total thrombotic and/or bleeding events than combination therapy in patients with AF and stable CAD. Future studies should control which antiplatelet is used to further minimize any risk of confounding factors.
1. In a trial of patients with post-traumatic stress disorder, guided internet based cognitive behavioural therapy is non-inferior to individual face-to-face cognitive behavioural therapy.
Evidence Rating Level: 1 (Excellent)
Post-traumatic stress disorder (PTSD) is a common mental health condition with substantial physical and mental health morbidity. Individual face-to-face cognitive behavioural therapy with a trauma focus (CBT-TF) is one of the best evidenced treatment for PTSD. Unfortunately, there are many barriers to accessing such a treatment, including lack of resources, long wait-times, and financial barriers for patients. Therefore, this randomized controlled trial sought to evaluate the clinical and cost effectiveness of an internet-based guided CBT-TF compared with face-to-face CBT-TF for people with mild to moderate PTSD. The study recruited 196 patients (mean [SD] age, 36.5 [13.4] years; 125 [63.8%] women), from which 99 were randomized to the control group and 99 to the intervention group. The control group received 12 face-to-face, manual-based, individual CBT-TF sessions (each lasting 60-90 minutes). Meanwhile, the intervention group received internet guided CBT-TF with an eight-step online program, up to three hours of contact with a therapist and four brief telephone calls or email contacts between sessions. The primary outcome measured was measured by the PTSD Scale for DSM-5 (CAPS-5) at 16 weeks after randomisation. The study found that the internet guided CBT-TF was non-inferior to the face-to-face CBT-TF at the 16-week endpoint on the CAPS-5 (mean difference 1.01; P=0.012). Secondary outcomes measured were severity of PTSD symptoms at 52 weeks, functioning, symptoms of depression and anxiety, use of alcohol, and perceived social support at 16 and 52 weeks after randomisation. Similarly, the study found that internet-guided CBT-TF was non-inferior to the traditional treatment. Furthermore, internet-based CBT-TF was significantly (P<0.001) cheaper than face-to-face CBT-TF. Therefore, the study concluded that guided internet-based CBT-TF was non-inferior to individual face-to-face CBT-TF for patients with mild-to-moderate PTSD and should be considered a first line treatment for people with this condition. However, the small sample size and high loss to follow-up decrease the internal validity of this study and larger scale studies are needed to support these results.
1. In a trial of diabetic patients undergoing open heart surgeries, using an automated glucose control pump maintained most patients within a predefined glucose range.
Evidence Rating Level: 1 (Excellent)
Studies have demonstrated that intraoperative glycemic variability is associated with increased risks of mortality and morbidity as well as an increased incidence of hyperglycemia after cardiac surgery. However, there exist many barriers to widespread adoption of tight glucose control including increased risk of severe hypoglycemia, difficulty in achieving normoglycemia, and resource constraints. Therefore, this study sought to examine the effectiveness of an automated closed loop glucose control system on intra- and post- operative glucose levels in patients undergoing open heart surgeries. It enrolled 59 patients of which 29 were placed in the control group (mean [SD] age, 61.0 [9.3] years, 10 [34.5%] females) and 30 in the intervention group (mean [SD] age, 64.3 [7.7] years, 4 [13.3%] females). In the control group, patients received standard of care which involved managing glucose levels with the instructions of the anesthesiologist using a sliding scale. Meanwhile, the intervention group patients were treated using the Space Glucose Control System which utilizes an already set algorithm to achieve a tight glucose window. In both groups, glucose measurements were obtained through an arterial blood gas sample taken every half an hour. The primary outcomes measured were the percentage of patients who had a target glucose level between 7.8 and 10 mmol as well as the percentage of patients who had at least one hypo- or hyper-glycemic events. It found that patients’ glucose levels maintained between 7.8 and 10 mmol throughout the surgery period and the percentage of time spent within this safety range were not significantly different between the two groups. However, patients who had at least one intraoperative hyperglycemic event were significantly higher in the control group compared to the experimental group (17 [58.6%] vs. 5 [16.7%]; odds ratio, 7.1; 95% CI, 2.1–23.8; p < 0.001, respectively). Overall, the study concluded that the automated glucose control pump maintained most of the patients within a predefined glucose range with a very low incidence of hyperglycemic events and no incidence of hypoglycemic events. However, a small sample size was a limitation in this study and larger studies are needed to further validate these results.
1. In a cohort of unvaccinated COVID-19 patients, prophylaxis with heparin at the intermediate or high dose did not reduce arterial or venous thromboembolism or all-cause death within 30 days but increased risk of major hemorrhagic events.
Evidence Rating Level: 2 (Good)
COVID-19 is an illness with many complications, including thromboembolic events. Therefore, many hospitals adopted the utilization of prophylactic anticoagulants, such as heparin, in patients hospitalized with COVID-19 to reduce their risk. However, despite their frequent usage, optimal dosing for prophylactic heparin has not been established to prevent thromboembolic events in COVID-19 patients with severe to critical disease. As a result, this retrospective cohort study sought to assess the risk/benefit ratio of different heparin doses regarding the incidence/risk of thromboembolism, major hemorrhagic events, and mortality amongst unvaccinated COVID-19 patients treated in emergency department. It analyzed data from 144 patients (mean [SD] age, 70  years; 33% female). The primary outcome measured was arterial or venous thromboembolism or all-cause mortality within 30 days. Amongst the patients, high-dose prophylactic heparin was used in 69%, intermediate in 15%, and low in 17%. The primary outcome occurred in 48 patients. The study demonstrated that intermediate/high dose heparin did not affect the risk of the primary outcome compared with the low dose (weighted HR, 1.39; 95% CI, 0.75–2.56; p = 0.292). The secondary outcomes measured were each single primary outcome evaluated individually or a major hemorrhagic event. The study found that intermediate/high heparin increased the risk of major hemorrhagic events (weighted HR, 5.92; 95% CI, 1.09–32; p = 0.039). Overall, the study concluded that amongst unvaccinated COVID-19 patients, prophylaxis with heparin at the intermediate/high dose did not significantly reduce primary outcome compared with the low dose but increased the risk of major hemorrhagic events. However, larger prospective studies are required to validate these results and further create clinical guidelines.
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