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Clinical validation of a cell-free DNA test for colorectal cancer screening: sensitivity and specificity analysis
20 Mar, 2024 | 19:16h | UTCStudy Design and Population: This study conducted a clinical validation of a cell-free DNA (cfDNA) blood-based test to screen for colorectal cancer in a cohort of 10,258 individuals, 7,861 of whom met the eligibility criteria and were evaluable. The research aimed to assess the test’s performance by comparing its sensitivity for detecting colorectal cancer and its specificity for identifying advanced neoplasia (including colorectal cancer or advanced precancerous lesions) against the outcomes of screening colonoscopy, a standard procedure.
Main Findings: The cfDNA test demonstrated a sensitivity of 83.1% for detecting colorectal cancer, with stage-specific sensitivities of 87.5% for stages I-III cancers. However, its sensitivity for identifying advanced precancerous lesions was notably lower at 13.2%. On the specificity front, the test showed an 89.6% ability to correctly identify individuals without any advanced colorectal neoplasia and had an overall specificity of 89.9% for those with a negative colonoscopy result, indicating no presence of colorectal cancer, advanced precancerous lesions, or non-advanced precancerous lesions.
Implications for Practice: The cfDNA blood-based test presents a promising tool for colorectal cancer screening, boasting substantial sensitivity for colorectal cancer detection and high specificity for advanced neoplasia. Its non-invasive nature could potentially enhance screening adherence, facilitating earlier cancer detection and possibly reducing colorectal cancer-related mortality. However, the test’s low sensitivity for advanced precancerous lesions suggests a need for further research and development to improve early detection capabilities.
Reference: Chung, D.C. et al. A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening. Journal Name, Volume(Issue), Pages. Access the study here: [Link]
RCT: Effectiveness of mechanical and oral antibiotic bowel preparation in reducing postoperative complications in elective rectal resection
20 Mar, 2024 | 18:18h | UTCStudy Design and Population
This double-blind, placebo-controlled randomized clinical trial was conducted at three university hospitals in Finland, involving 565 patients aged 18 years and older undergoing elective rectal resection with primary anastomosis for tumors 15 cm or less from the anal verge, as determined by magnetic resonance imaging. Participants were allocated in a 1:1 ratio to either the mechanical and oral antibiotic bowel preparation (MOABP) group, receiving neomycin and metronidazole orally, or to the mechanical bowel preparation (MBP) plus placebo group, with all interventions occurring the day before surgery alongside standard preoperative intravenous antibiotics.
Main Findings
The study found that patients in the MOABP group experienced significantly fewer postoperative complications, with a median Comprehensive Complication Index significantly lower than that of the MBP plus placebo group. Additionally, the MOABP group showed reduced rates of surgical site infections (SSIs) and anastomotic dehiscence compared to the control group, demonstrating a clear benefit in postoperative outcomes.
Implications for Practice
The results of this trial suggest that incorporating oral antibiotics with mechanical bowel preparation prior to elective rectal resection significantly reduces postoperative complications, including SSIs and anastomotic dehiscence. Therefore, MOABP should be adopted as the standard regimen for patients undergoing these procedures to improve postoperative outcomes and reduce the burden of complications. This evidence underscores the importance of updating surgical protocols to include this preparation strategy.
Reference
Laura Koskenvuo et al. (2024). Randomized Clinical Trial: Effectiveness of Mechanical and Oral Antibiotic Bowel Preparation in Reducing Postoperative Complications in Elective Rectal Resection. JAMA Surg, Published online March 20, 2024. DOI: 10.1001/jamasurg.2024.0184. Access the study here: [Link]
RCT: Quadruple quarter-dose hypertension medication versus monotherapy for ambulatory blood pressure control
20 Mar, 2024 | 18:00h | UTCStudy Design and Population: This randomized clinical trial investigated the efficacy of a combination of four ultra-low-dose blood pressure medications (quadpill) compared to standard monotherapy in adults with hypertension. A total of 591 participants, either untreated or currently on monotherapy for hypertension, were enrolled and randomly assigned to receive either the quadpill (irbesartan 37.5 mg, amlodipine 1.25 mg, indapamide 0.625 mg, and bisoprolol 2.5 mg) or a monotherapy control (irbesartan 150 mg).
Main Findings: At 12 weeks, the quadpill group demonstrated significantly lower mean 24-hour ambulatory systolic and diastolic blood pressure (SBP and DBP) by 7.7 mmHg and 5.3 mmHg, respectively, compared to the monotherapy group, with similar reductions observed during daytime and night-time. Additionally, the rate of blood pressure control (24-hour average BP < 130/80 mmHg) was significantly higher in the quadpill group (77% vs. 50%). The study highlighted the quadpill’s effectiveness in reducing blood pressure variability and enhancing control rates across a 24-hour period.
Implications for Practice: The findings from this study support the superior efficacy of an ultra-low-dose quadruple medication strategy over monotherapy in managing ambulatory blood pressure among hypertensive patients. These results suggest that a quadpill approach could offer a more effective means for clinicians to achieve and maintain blood pressure control in hypertensive patients, potentially improving cardiovascular outcomes.
Reference: Janis M Nolde et al. (2024). Ambulatory blood pressure after 12 weeks of quadruple combination of quarter doses of blood pressure medication vs. standard medication. J Hypertens, 2024 Feb 29. DOI: 10.1097/HJH.0000000000003683. Access the study here: [Link]
Meta-Analysis: Efficacy of exercise modalities in major depressive disorder treatment
20 Mar, 2024 | 17:54h | UTCStudy Design and Population: This article presents a systematic review and network meta-analysis of randomized controlled trials to assess the optimal dose and modality of exercise for treating major depressive disorder, comparing its effects to psychotherapy, antidepressants, and control conditions such as usual care or placebo. The review included 218 unique studies encompassing 495 arms with a total of 14,170 participants who met the clinical cutoffs for major depression.
Main Findings: The findings revealed moderate reductions in depression symptoms for several exercise modalities when compared to active controls. Notably, walking or jogging, yoga, and strength training demonstrated the most significant effects. The effectiveness of exercise was found to be proportional to the intensity of the activity prescribed. Among these, yoga and strength training were identified as the most acceptable modalities for participants. However, the overall confidence in these results is low due to the high risk of bias in the included studies, with only one study meeting the criteria for a low risk of bias.
Implications for Practice: The study concludes that exercise, particularly walking or jogging, yoga, and strength training at sufficient intensities, can be an effective treatment for major depressive disorder. These modalities could be recommended alongside traditional treatments such as psychotherapy and antidepressants. Future research should focus on blinding participants and staff to mitigate expectancy effects and improve the reliability of findings. The inclusivity of exercise as a core treatment for depression could significantly impact treatment strategies and patient outcomes.
Reference: Noetel, M., et al. (2024). Effect of exercise for depression: systematic review and network meta-analysis of randomised controlled trials. BMJ, 384, e075847. DOI: https://doi.org/10.1136/bmj-2023-075847. Access the study here: [Link]
Phase 2 RCT: Low-dose aspirin significantly reduces hepatic fat in MASLD patients without cirrhosis
20 Mar, 2024 | 17:48h | UTCStudy Design and Population: This phase 2, randomized, double-blind, placebo-controlled clinical trial was carried out over six months at a single hospital in Boston, Massachusetts. The study included 80 participants aged 18 to 70 years diagnosed with metabolic dysfunction–associated steatotic liver disease (MASLD) but without cirrhosis. Participants were randomly assigned to receive either 81 mg of daily aspirin (n=40) or placebo (n=40).
Main Findings: The trial revealed that aspirin significantly reduced the mean absolute change in hepatic fat content by -10.2% compared with placebo, as measured by proton magnetic resonance spectroscopy (MRS), with a statistically significant difference (P=0.009). Furthermore, aspirin treatment notably decreased relative hepatic fat content, increased the proportion of patients achieving a 30% or greater reduction in hepatic fat, and reduced both absolute and relative hepatic fat content as assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF). Adverse events were mostly minor, with upper respiratory infections and arthralgias being the most common.
Implications for Practice: These findings suggest that low-dose aspirin may be an effective intervention for reducing liver fat in adults with MASLD without cirrhosis, potentially offering a simple, accessible treatment option. However, the results are preliminary and call for further confirmation in larger, more diverse populations. The study underscores the importance of considering low-dose aspirin as part of management strategies for MASLD, pending further research.
Reference
Simon TG et al. (2024). Randomized Clinical Trial: Low-Dose Aspirin Significantly Reduces Hepatic Fat in MASLD Patients Without Cirrhosis. JAMA, 331(11), 920-929. DOI: 10.1001/jama.2024.1215. Access the study here: [Link]
Prospective Study: Enhanced detection of colorectal cancer and precancerous lesions with next-generation stool DNA testing
20 Mar, 2024 | 17:41h | UTCStudy Design and Population:
This prospective study evaluated the efficacy of a next-generation multitarget stool DNA test for colorectal cancer screening in asymptomatic adults aged 40 and older. The study encompassed 20,176 participants undergoing screening colonoscopy to determine the test’s sensitivity and specificity in detecting colorectal cancer and advanced neoplasia, including advanced precancerous lesions.
Main Findings:
The next-generation stool DNA test demonstrated a sensitivity of 93.9% for detecting colorectal cancer and a specificity of 90.6% for advanced neoplasia, significantly outperforming the fecal immunochemical test (FIT) in sensitivity for both colorectal cancer and advanced precancerous lesions. However, the test showed slightly lower specificity for advanced neoplasia compared to FIT. No adverse events were reported, indicating the test’s safety for screening purposes.
Implications for Practice:
The findings suggest that the next-generation multitarget stool DNA test offers a superior option for colorectal cancer screening, with significantly higher sensitivity for detecting cancer and advanced precancerous lesions than the currently available FIT. This advance in non-invasive screening technology could lead to earlier detection and treatment of colorectal cancer, potentially improving patient outcomes. Further research may focus on optimizing the balance between sensitivity and specificity to enhance the clinical utility of stool DNA testing.
Reference:
Introducing IntelliDoctor: The Future of Medical Inquiry for Medical Professionals
26 Feb, 2024 | 11:21h | UTCWe are thrilled to introduce IntelliDoctor, an innovative platform designed specifically for medical professionals, aiming to revolutionize the way medical inquiries are addressed. At IntelliDoctor, we understand the critical need for accurate, timely, and evidence-based information in the medical field. Our platform leverages advanced AI technology, including sophisticated prompt engineering and Retrieval Augmented Generation (RAG), to provide precise answers to clinical questions.
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AI-Powered GPTs for Doctors: Evidence-Based Medicine & Clinical Decision Support Prompts
17 Dec, 2023 | 18:39h | UTCWelcome to IntelliDoctor’s innovative collection of AI-Powered GPT Prompts, specifically designed for doctors seeking to enhance their clinical practice with evidence-based information. Utilizing the latest Natural Language Processing (NLP) technology, our prompts provide decisive support in various aspects of medicine, from identifying drug interactions to differential diagnoses, treatments, and more. Each prompt has been meticulously developed to provide accurate and up-to-date information, assisting healthcare professionals in quickly accessing crucial data for patient care decision-making. Important: access to these specialized prompts requires a GPT-4 subscription. With our tool, doctors can easily obtain relevant clinical insights, optimizing time and improving the quality of medical care. Explore our 6 specialized prompts and discover how artificial intelligence can transform your medical practice.
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RCT: No difference in ICU length of stay or 90-day mortality between tight and liberal glucose control
2 Oct, 2023 | 11:25h | UTCStudy Design and Population: This randomized controlled trial assessed the effects of tight versus liberal glucose control on the length of ICU stay in critically ill patients. A total of 9,230 patients were included, with 4,622 in the liberal-control group (insulin initiation when blood glucose levels exceeded 215 mg/dL) and 4,608 in the tight-control group (blood glucose targeted between 80 and 110 mg/dL). In both groups, parenteral nutrition was withheld during the first week of ICU admission. The primary endpoint was the duration of ICU stay, and 90-day mortality served as a key safety outcome.
Main Findings: No significant differences were observed in the primary endpoint, the length of ICU stay, between the two groups (hazard ratio 1.00; 95% CI, 0.96 to 1.04; P=0.94). The 90-day mortality rates were also similar (10.1% in the liberal-control group vs. 10.5% in the tight-control group, P=0.51). Incidences of severe hypoglycemia were low and statistically similar in both groups (1.0% in the tight-control group vs. 0.7% in the liberal-control group). Secondary outcomes, including new infections and the duration of respiratory and hemodynamic support, showed no significant differences. However, lower incidences of severe acute kidney injury and cholestatic liver dysfunction were observed in the tight-control group.
Implications & Limitations: The study supports existing evidence that tight glucose control doesn’t provide substantial benefits in reducing ICU stay duration or mortality. This suggests that a more liberal approach to glucose control may be preferable in most ICU settings, especially to minimize hypoglycemia risk. Key limitations of the study include its narrow focus on the absence of early parenteral nutrition, which could limit generalizability, and the inability to blind caregivers to treatment assignments. Future research should investigate the impact of tight glucose control in various patient subgroups and under different nutritional conditions.
RCT: Propafenone leads to quicker sinus rhythm restoration than amiodarone in supraventricular arrhythmias related to septic shock
1 Oct, 2023 | 15:19h | UTCStudy Design & Population: The research was a two-center, prospective, controlled parallel-group, double-blind trial involving 209 septic shock patients who had new-onset supraventricular arrhythmia and a left ventricular ejection fraction above 35%. Patients were randomized to receive either intravenous propafenone (70 mg bolus followed by 400–840 mg/24 h) or amiodarone (300 mg bolus followed by 600–1800 mg/24 h).
Main Findings: The primary outcomes focused on the proportion of patients in sinus rhythm 24 hours post-infusion, time to the first sinus rhythm restoration, and arrhythmia recurrence rates. No significant difference was observed in 24-hour sinus rhythm rates between the propafenone (72.8%) and amiodarone (67.3%) groups (p=0.4). Time to the first rhythm restoration was significantly shorter for the propafenone group (median 3.7 hours) compared to the amiodarone group (median 7.3 hours, p=0.02). Recurrence of arrhythmia was notably lower in the propafenone group (52%) than in the amiodarone group (76%, p<0.001). In the subgroup of patients with a dilated left atrium, amiodarone appeared to be more effective.
Implications & Limitations: The study suggests that while propafenone doesn’t offer better rhythm control at 24 hours compared to amiodarone, it does provide faster cardioversion and fewer arrhythmia recurrences, especially in patients with a non-dilated left atrium. No significant differences were observed in clinical outcomes, such as ICU or long-term mortality, between propafenone and amiodarone in the trial. Limitations include potential underpowering of the study and the inability to fully account for the impact of multiple covariates involved in the complex therapy of septic shock.
Commentary on Twitter:
Propafenone?70 mg bolus+ 400-840 mg/24h vs amiodarone?300 mg + by 600-1800 mg/24h for SVA in septic shock, RCT
?propafenone not better for rhythm control at 24h but excellent hemodynamic safety profile, cardioverting faster & fewer recurrences#FOAMCc
?https://t.co/GVuoxPD7Hy pic.twitter.com/rRlj00x71p— Intensive Care Medicine (@yourICM) September 13, 2023
LinksMedicus.com: operations paused for the foreseeable future.
23 Aug, 2023 | 12:44h | UTCDear LinksMedicus Subscribers,
I regret to inform you that LinksMedicus.com will be pausing operations for the foreseeable future. After 12 years and over 30.000 curated articles in all specialties, I will now focus on my clinical practice.
Best regards to all.
Euclides Cavalcanti
São Paulo, Brazil
Pragmatic Cluster-Randomised Trial: Efficacy of a Fixed-Dose Polypill in Reducing Cardiovascular Disease Risk in Rural Iran
25 Mar, 2024 | 11:40h | UTCStudy Design and Population: The PolyPars Study was structured as a two-arm pragmatic cluster-randomised trial within the larger PARS cohort study. It targeted residents aged over 50 in a district in southern Iran, dividing 91 villages into two groups: one receiving a once-daily polypill (containing two antihypertensives, a statin, and aspirin) alongside non-pharmacological interventions, and the other receiving only the non-pharmacological interventions. The trial included 4,415 participants aged 50-75 years, with the primary endpoint being the first occurrence of major cardiovascular events.
Main Findings: Over a median follow-up of 4.6 years, adherence to the polypill was high at 86%. The intervention arm showed a significant reduction in the incidence of the primary outcome, with only 4.0% (88 participants) experiencing major cardiovascular events compared to 8.0% (176 participants) in the control arm. This translates to a hazard ratio of 0.50, indicating a 50% reduction in risk, and an absolute risk reduction of 4.0%.
Implications for Practice: The study demonstrates the significant potential of fixed-dose combination therapy with the polypill to halve the risk of major cardiovascular diseases in a population-level intervention. This finding supports the polypill as a safe and effective strategy for both primary and secondary prevention of cardiovascular diseases, particularly in settings where access to individual medications and consistent medical supervision might be limited.
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Crossover RCT | Using one-size cuff results in major inaccuracy in BP readings across varying arm sizes
11 Aug, 2023 | 15:41h | UTCEffects of Cuff Size on the Accuracy of Blood Pressure Readings: The Cuff(SZ) Randomized Crossover Trial – JAMA Internal Medicine (free for a limited period)
Commentaries:
When it comes to blood pressure cuffs, size matters – MedicalResearch.com
One-size-fits-all blood pressure cuffs ‘strikingly inaccurate,’ study says – CNN
Related:
Commentary on Twitter
Using a regular blood pressure (BP) cuff regardless of individual’s arm size resulted in 3.6 mmHg lower systolic BP when a regular cuff was one size too-large, and 4.8 and 19.5 mmHg higher when a regular cuff was one and two sizes too small. https://t.co/ZKnGfWc9fy
— JAMA Internal Medicine (@JAMAInternalMed) August 7, 2023
Perspective | Clinicians debate the usefulness of NAFLD name change
11 Aug, 2023 | 15:39h | UTCClinicians debate the usefulness of NAFLD name change – MDedge
Original article: From NAFLD to MASLD | New consensus changes fatty liver disease terminology to avoid stigmatization
Presented at ASRS Meeting | Studies link GLP-1 agonists to progression of diabetic retinopathy
11 Aug, 2023 | 15:38h | UTCStudies link GLP-1 agonists to progression of diabetic retinopathy – MDedge
Study | The high financial and human cost of quality metric reporting in hospitals
11 Aug, 2023 | 15:36h | UTCThe Volume and Cost of Quality Metric Reporting – JAMA (link to abstract – $ for full-text)
Author Interview: The Costs of Quality Reporting – JAMA
Commentaries:
The Cost of “Quality” – Emergency Medicine Literature of Note
How John Hopkins spent $5m and 108,478 hours on quality reporting in one year – HealthLeaders
The cost of quality metric reporting – Becker’s Hospital Review
Study | Uncovering the potential overuse of laboratory tests by combining cost, abnormal result proportion, and physician variation
11 Aug, 2023 | 15:34h | UTC
Guideline | Closure of laparotomy in emergency settings
11 Aug, 2023 | 15:33h | UTC
ERS statement on protracted bacterial bronchitis in children
11 Aug, 2023 | 15:32h | UTCERS statement on protracted bacterial bronchitis in children – European Respiratory Journal
Perspective | AI predicted to play major role in cardiac CT and CV care in the coming decade
11 Aug, 2023 | 15:30h | UTCAI Predicted to Play Major Role in Cardiac CT and CV Care in the Coming Decade – TCTMD
M-A | Pharmacist-led home BP telemonitoring enhances control over usual care
11 Aug, 2023 | 15:29h | UTC
RCT | Superior PFS with avelumab vs. chemotherapy in second-line treatment for mCRC with microsatellite instability
11 Aug, 2023 | 15:25h | UTCSee also: Visual Abstract
Commentary: Avelumab Outperforms Standard Second-Line Therapy in dMMR/MSI Metastatic CRC – Cancer Therapy Advisor
Review | An approach to non-left main bifurcation lesions
11 Aug, 2023 | 15:22h | UTCAn Approach to Non-left Main Bifurcation Lesions: A Contemporary Review – US Cardiology Review
Commentary on Twitter
?Do you know how to classify, assess, and treat non-left main bifurcation lesions with PCI?
New #USCardiology Review by @ANazmiCalik, @mirvatalasnag et al. @radcliffeCARDIO
?https://t.co/PeUcLxUerx pic.twitter.com/qh2FdUTbdE
— Amit Goyal MD MAS (@AmitGoyalMD) August 4, 2023
Cohort Study | Mortality risk in anti-MDA5 dermatomyositis linked to rapid ILD progression and anti-Ro52 antibody levels
11 Aug, 2023 | 15:21h | UTC
Commentary on Twitter
High mortality risk predictors in patients with anti-MDA5 dermatomyositis include:
– rapidly progressive interstitial lung disease
– anti-Ro52 antibody
– age > 57 years
(based on study of 126 MDA-5+ DM pts)https://t.co/JLGIgALUip pic.twitter.com/boTTzrixk9— Dr. John Cush (@RheumNow) August 5, 2023
Systematic Review | Poor handling of continuous predictors in clinical prediction models using logistic regression
11 Aug, 2023 | 15:19h | UTC