Background: Efficacy of an intervention is commonly evaluated using P values, in addition to effect size measures such as absolute risk reduction, relative risk reduction, and numbers needed to treat. However, these measures are not always intuitive to clinicians. The fragility index (FI) is a more intuitive number that can facilitate interpretation but can only be used with binary outcomes. FI is the minimum number of patients who must be moved from the nonevent group to the event group to turn a significant result nonsignificant. In this retrospective analysis, we assessed the robustness of cardiovascular randomized controlled trials (RCTs), which report a positive (statistically significant) primary outcome by using the FI. Methods and Results: We searched Medline from 2007 to 2017 to identify cardiovascular RCTs published in 6 high impact journals ( The Lancet , New England Journal of Medicine , Journal of the American Medical Association , Circulation , Journal of the American College of Cardiology and European Heart Journal ). Only RCTs with sample sizes >500 and a 2-by-2 factorial design or dichotomous primary outcomes were selected. FI was calculated using a defined approach. Among the cohort of 123 RCTs that met inclusion criteria, median FI was 13 (interquartile range, 5–26). In 28 trials (22.8%), FI ranged between 1 and 4. In 37 trials (30.1%), number of patients lost to follow-up was higher than the FI. Pharmaceutical interventions had higher FI compared with other interventions, FI=19 (7–52; P =0.002). Median FI varied according to subspecialty (electrophysiology=2; heart failure=11; interventional cardiology=8; P =0.020) and multiregional RCTs had higher FI=22 (12–53.25; P =0.023). FI did not differ based on risk of bias indicators, funding, or publication year. Conclusions: Considerable variations in FI were observed among cardiovascular trials, suggesting the need for careful interpretation of results, particularly when number of patients lost to follow-up exceeds FI.
Background: In the busy world of cardiovascular medicine, abstracts may be the only part of a publication that clinicians read. Therefore, it is critical for abstracts to accurately reflect article content. The extended CONSORT (Consolidated Standards of Reporting Trials) Statement for Abstracts was developed to ensure high abstract quality. However, it is unknown how often adherence to CONSORT guidelines occurs among cardiovascular journals. Methods and Results: We searched MEDLINE for randomized controlled trials published in 3 major cardiovascular journals ( Circulation, Journal of the American College of Cardiology , and European Heart Journal ) from 2011 to 2017. Post hoc, interim, and cost-effective analyses of randomized controlled trials were excluded. Two independent investigators extracted the data using a prespecified data collection form and a third investigator adjudicated the data. The primary outcome was frequency of subcategory adherence to CONSORT guidelines. A total of 478 abstracts were included in the analysis. Approximately half of the abstracts (53%; 255/478; 95% CI, 49%–57%) identified the article as randomized in the title. All abstracts detailed the interventions for both study groups (100%) and 81% (95% CI, 78%–85%) reported trial registration. Methodological quality reporting was relatively low: 9% (45/478; 95% CI, 6%–12%) described participant eligibility criteria with settings for data collection, 43% (204/478; 95% CI, 39%–47%) reported details of blinding, and <1% (4/478; 95% CI, 0%–2%) reported allocation concealment. Approximately 60% (301/478; 95% CI, 59%–67%) of the included abstracts provided primary outcome results while 55% (262/478; 95% CI, 51%–60%) reported harms or adverse effects. Conclusions: There is a high prevalence of nonadherence to CONSORT guidelines among leading cardiovascular journals. Efforts by editors, authors, and reviewers should be made to increase adherence and promote transparent and unbiased presentation of study results.
Over the past few years, Serotonin Syndrome (SS) has become a significant clinical concern. Over the last decade, United States saw a surge in antidepressant use. SS characteristically presents as the triad of altered mental status, autonomic dysfunction and neuromuscular excitation. Symptoms vary from patient to patient with mild cases presenting with subacute symptoms and severe cases progressing rapidly to death. Due to the protean manifestations of the syndrome along with non-specific prodromal, SS can easily be misdiagnosed if not carefully assessed. In severe cases, SS can be mistaken as neuroleptic malignant syndrome while mild cases are mostly misattributed to other causes such as flu. SS is a clinical diagnosis and therefore, requires a thorough review of medications and physical examination. Given the protean nature of this toxicologic syndrome various criteria were defined which includes Sternbach's, Radomski and Hunter's criteria. Keeping in mind the wide symptoms of serotonin syndrome from being barely perceptible to lethal emphasis there is a need to treat the syndrome on urgent basis. Mainstay for treatment of serotonin syndrome is to discontinue the offending drug. Improvement is seen in most patients within 24 hours.
Background Since the outbreak, healthcare systems across the globe are overcrowded with coronavirus disease (COVID-19) patients. To sustain the response towards the pandemic, many hospitals have adapted to virtual healthcare and telemedicine. Google™ has become the most widely used search engine over the years. Google Trends™ can be used to depict the public interest over a certain topic. The output of the Google Trends™ is displayed as relative search volume (RSV) which is the proportionate search volume regarding a specific topic comparative to the total search volume in a specific time and region. The primary aim of this study was to evaluate the relationship between the daily reported number of new COVID-19 cases and deaths and the corresponding changes in Google Trends™ RSV of telehealth over six months. Methods A retrospective study was conducted from January 21, 2020 to July 21, 2020. About 17 countries that reported the total number of cases greater than 200,000 in the situation report of July 21, 2020 were selected to be a part of this study. The daily reported new cases and deaths globally and of the selected countries were extracted from the World Health Organization (WHO) situation reports. The combination of keywords used for obtaining the RSV data through Google Trends™ was "telehealth", "telemedicine", "mHealth", and "eHealth". These words were used with the "+" feature of Google Trends™ with "1/21/2020 to 7/21/2020" as time range, "all categories" for the category, and "web search" for the type of search. The worldwide RSV as well as the RSVs of the selected countries were obtained from the Google Trends™ website. Spearman's correlation coefficient (ρ) was used to determine the strength of the relationship between new cases or deaths and RSVs related to telehealth. Results A positive fair correlation was established between the global interest in telehealth and the new cases (ρ=0.307, p-value<0.001) and deaths (ρ=0.469, p-value<0.001) reported worldwide. The United States of America (USA), India, and Bangladesh were found to have a positive fair correlation between the public interest regarding telehealth and the emerging new COVID-19 cases and deaths. The United Kingdom (UK) and Italy demonstrated a positive poor correlation between the rising new cases or deaths and RSV. Similar statistics were noted for the daily new cases of Chile. For Turkey, a positive fair correlation between new deaths and RSV while a positive poor correlation between new cases and RSV was observed. No significant correlation was observed for the rest of the selected countries.
Obturator hernia is an extremely rare condition accounting for almost 0.07%-1% of all abdominal wall hernias, usually occurring in the elderly and emaciated females with a history of previous abdominal surgery. The symptoms of this particular hernia are non-specific; therefore, a high index of clinical suspicion should always be made. This rare condition may lead to acute small intestinal obstruction. The pre-operative diagnosis is challenging and often misleading on occasions, especially in co-morbid cases. This leads to delayed diagnosis and surgical intervention, hence causing an increased morbidity and mortality rate. The computed tomography (CT) scan of the abdomen and pelvis is the gold standard for diagnosis. We present a case of an 80-year-old female, with known comorbid of hypertension, initially diagnosed as peritonitis and on further examination revealed strangulated obturator hernia with proximal perforation, that underwent lower midline laparotomy with resection of necrotic bowel, an end-to-end anastomosis, and repair of the defect by vicryl suture.
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