Questioning Medicine

Questioning Medicine
Questioning Medicine

Join Andrew on a medical rollercoaster as we ask a medical question and answer it based on recent published papers.  

  1. 1 DAY AGO

    260. METHODS MONDAY-- EVENT RATE

    Methods Monday  --- Accuracy of Event Rate and Effect Size Estimation in Major Cardiovascular Trials: A Systematic Review | Cardiology | JAMA Network Open | JAMA Network  During the design of a randomized clinical trial (RCT), estimation of the expected event rate and effect size is a key component to calculating the sample size. Overly optimistic estimation of event rates and effect sizes may lead to underpowered trials. If you expect 1 event per 100 people and you are looking for 5 events then you only need to enroll….. 500 people but if the actual event rate is 1 per 200 people then in order to get 5 events you need to enroll 1000 people!! You can see enrolling 500 people instead of 1000 would underpower your trial  This article, published in JAMA Network Open in April 2024, presents a systematic review of 344 contemporary cardiovascular randomized clinical trials (RCTs) to evaluate the accuracy of estimated event rates and effect sizes1. The key findings are:Event rates were frequently overestimated:Median observed event rate: 9.0% (IQR, 4.3%-21.4%)Median estimated event rate: 11.0% (IQR, 6.0%-25.0%)61.1% of trials overestimated the event rate1Effect sizes were often overestimated:Median observed effect size: 0.91 (IQR, 0.74-0.99)Median estimated effect size: 0.72 (IQR, 0.60-0.80)82.1% of trials overestimated the effect sizeThe drug companies think their drug is way better than it is or observed to be in trials1Device trials were independently associated with decreased accuracy of event rate estimation compared to drug trials1.The study concludes that the frequent overestimation of event rates and effect sizes in cardiovascular RCTs may contribute to underpowered trials and the inability to adequately test trial hypotheses1. This finding has implications for trial design—if we are not accurate or realistic about the interventions we are likely to underpower the study which means you have to do the whole thing all over again or likely all over again and risk FDA rejecting you drug.

    10 min
  2. 4 DAYS AGO

    259. Urinary Retention Evaluation and Catheterization Algorithm for Adult Inpatients

    https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2821168A team of researchers set out to change that by developing a comprehensive algorithm.The process involved a multidisciplinary panel of 11 expertss with extensive experience in managing urinary retention. These experts evaluated about 100 clinical scenarios to create an initial flow sheet. The algorithm was then refined through interviews with 33 frontline clinicians from various specialties.So, what does this new algorithm recommend? Let's break it down:First, bladder scanning is the preferred method for evaluating patients with urinary retention symptoms. It's also recommended for asymptomatic patients who haven't voided in 3 hours.If a bladder scanner isn't available, the algorithm suggests using either an intermittent straight catheter (ISC) or an indwelling urinary catheter (IUC), with a preference for ISC initially.Now, let's talk about when to catheterize based on bladder scanner volumes. For symptomatic patients, catheterization is recommended when the volume is 300 mL or more. For asymptomatic patients, the threshold is higher at 500 mL or more.Lastly, the algorithm provides guidance on when to transition from intermittent to indwelling catheterization. If a patient needs an ISC more frequently than every 4 hours, or if their output is 500 mL or more every 4 hours, it's appropriate to switch to an IUC

    8 min
  3. JAN 3

    258. Oral Antibiotics and Risk of Serious Cutaneous Adverse Drug Reactions

    https://jamanetwork.com/journals/jama/article-abstract/2822097Design, Setting, and Participants  Nested case-control study using population-based linked administrative datasets among adults aged 66 years or older who received at least 1 oral antibiotic between 2002 and 2022 in Ontario, Canada. Cases were those who had an emergency department (ED) visit or hospitalization for serious cADRs within 60 days of the prescription, and each case was matched with up to 4 controls who did not.Exposure  Various classes of oral antibiotics.Main Outcomes and Measures  Conditional logistic regression estimate of the association between different classes of oral antibiotics and serious cADRs, using macrolides as the reference group.Results  During the 20-year study period, we identified 21 758 older adults (median age, 75 years; 64.1% female) who had an ED visit or hospitalization for serious cADRs following antibiotic therapy and 87 025 matched controls who did not. In the primary analysis, sulfonamide antibiotics (adjusted odds ratio [aOR], 2.9; 95% CI, 2.7-3.1) and cephalosporins (aOR, 2.6; 95% CI, 2.5-2.8) were most strongly associated with serious cADRs relative to macrolides. Additional associations were evident with nitrofurantoin (aOR, 2.2; 95% CI, 2.1-2.4), penicillins (aOR, 1.4; 95% CI, 1.3-1.5), and fluoroquinolones (aOR, 1.3; 95% CI, 1.2-1.4). The crude rate of ED visits or hospitalization for cADRs was highest for cephalosporins (4.92 per 1000 prescriptions; 95% CI, 4.86-4.99) and sulfonamide antibiotics (3.22 per 1000 prescriptions; 95% CI, 3.15-3.28). Among the 2852 case patients hospitalized for cADRs, the median length of stay was 6 days (IQR, 3-13 days), 9.6% required transfer to a critical care unit, and 5.3% died in the hospital.Conclusion and Relevance  Commonly prescribed oral antibiotics are associated with an increased risk of serious cADRs compared with macrolides, with sulfonamides and cephalosporins carrying the highest risk. Prescribers should preferentially use lower-risk antibiotics when clinically appropriate.

    6 min
  4. 12/20/2024

    254. 2024 ESC Guidelines for the management of elevated blood pressure and hypertension

    2024 ESC guidelines propose a simple new BP categorization:Non-elevated: less than 120/70 mm Hg in the office (pharmacological treatment is not recommended).Elevated: 120 to 139/70 to 89 mm Hg (pharmacological treatment is recommended for some, depending on cardiovascular disease [CVD] risk and follow-up BP measurements).Hypertension: 140/90 mm Hg or greater (confirmation and prompt pharmacological treatment is recommended).    lifestyle interventions are particularly critical for individuals with an elevated BP but a low predicted risk of CVD. Adults in this group are common and account for up to one-third of all CVD events,  2024 ESC Guidelines provide two major new lifestyle approaches for managing elevated BP and hypertension.  first new option is potassium supplementation, either by dietary supplementation or potassium-enriched salt substitutes. The mechanistic and observational data supporting the benefits of potassium supplementation on BP are not new. However, recent CVD outcomes trials demonstrate the benefits of potassium supplementation where clinically appropriate.  Potassium-enriched salts typically contain 75% sodium chloride and 25% potassium chloride, while dietary potassium sources include foods such as bananas (450 mg per medium-sized banana), unsalted boiled spinach (840 mg per cup), and mashed avocado (710 mg per cup)  The second new option is to increasingly understand the BP-lowering benefits of resistance exercise training.4 Not everyone can perform the aerobic exercises traditionally recommended in BP management guidelines, and resistance exercise offers an important alternative for both clinicians and patients.  ANY EXERCISE

    8 min
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Join Andrew on a medical rollercoaster as we ask a medical question and answer it based on recent published papers.  

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