Randomized Trials
A giant trial of COVID-19 treatments organized by the WHO is restarting. Here are the drugs it’s betting on.
10 Aug, 2021 | 09:52h | UTCA giant trial of COVID-19 treatments is restarting. Here are the drugs it’s betting on – Science
Related: WHO Solidarity trial to restart with focus on drugs that act on immune responses caused by Covid-19.
Giving and taking: ethical treatment assignment in controlled trials.
10 Aug, 2021 | 08:52h | UTCGiving and taking: ethical treatment assignment in controlled trials. – The James Lindt Library
Commentary on Twitter
It was a pleasure and an honour to collaborate with @iainchalmersTTi in writing this piece https://t.co/TP66e4FAOd on ethical issue in treatment assignment in clinical trials. #clinicaltrials
— Stephen John Senn (@stephensenn) August 9, 2021
Secondary analysis of RCT finds Dapagliflozin is safe for patients with stage 4 chronic kidney disease.
10 Aug, 2021 | 08:51h | UTCCommentaries:
No Increase in Risk With Dapagliflozin in Patients With Stage 4 CKD – HealthDay
[Preprint] RCT: non-invasive respiratory strategies in acute respiratory failure in patients with COVID-19 – CPAP reduced the composite outcome of intubation or death within 30 days; high-flow nasal oxygenation was not associated with better outcomes.
6 Aug, 2021 | 10:18h | UTCCommentary: Covid: Pressured oxygen reduces ventilator need – BBC
Commentary on Twitter (thread – click for more)
RECOVERY-RS results out, and confirm what most of us have been doing:
CPAP reduces intubation/mortality by 28% compared with no CPAP/HFNO (composite outcome, mostly intubation)
Nasal high flow not so successful1/https://t.co/bcB2sTdAsu pic.twitter.com/fvT8IbyxUr
— 𝚃𝚘𝚖 𝙻𝚊𝚠𝚝𝚘𝚗 💙 (@LawtonTri) August 5, 2021
RCT: Subcutaneous REGEN-COV antibody combination prevented symptomatic Covid-19 infection in previously uninfected household contacts of infected persons.
5 Aug, 2021 | 09:01h | UTCSubcutaneous REGEN-COV Antibody Combination to Prevent Covid-19 – New England Journal of Medicine
Related:
Commentary on Twitter
Subcutaneous REGEN-COV prevented symptomatic #COVID19 and asymptomatic #SARSCoV2 infection in previously uninfected household contacts. https://t.co/rRNFTjS9hX pic.twitter.com/B7qXeyWKUb
— NEJM (@NEJM) August 4, 2021
RCT: 7 days of antibiotic therapy as good as 14 days for afebrile men with urinary tract infection.
28 Jul, 2021 | 10:03h | UTCEffect of 7 vs 14 Days of Antibiotic Therapy on Resolution of Symptoms Among Afebrile Men With Urinary Tract Infection: A Randomized Clinical Trial – JAMA (free for a limited period)
Editorial: Shorter Courses of Antibiotics for Urinary Tract Infection in Men (free for a limited period)
Commentary: Study Supports Shorter Antibiotic Course for Afebrile Men With UTI – MPR
Commentary on Twitter
Practice changing study, we always consider UTI in men as a complicated disease and we usually treat for longer time sometimes even more than 14 days, this study found that you can treat for shorter time ~7 days #IDTwitter #medtwitter #TwitteRx https://t.co/LSWYTAG15y
— Antibiotic Steward Bassam Ghanem 🅱️C🆔🅿️🌟 (@ABsteward) July 27, 2021
Cluster RCT: Effectiveness of a tailored intervention to reduce antibiotics for urinary tract infections in nursing home residents.
27 Jul, 2021 | 03:25h | UTCEffectiveness of a tailored intervention to reduce antibiotics for urinary tract infections in nursing home residents: a cluster, randomised controlled trial – The Lancet Infectious Diseases (link to abstract – $ for full-text)
Commentary on Twitter
In this open-label, cluster randomised controlled trial, there was reduction in the number of antibiotic prescriptions for urinary tract infections by 58% in Danish nursing home residents without substantially increasing the risk of all-cause hospitalisa… https://t.co/LXO0LIFmTU
— Abid Hussain (@MicrobLog_me_uk) July 23, 2021
RCT: Real time remote symptom monitoring during chemotherapy for cancer may reduce symptom burden and improve quality of life.
26 Jul, 2021 | 02:18h | UTCCommentaries:
Remote 24-hour monitoring shows sizable, positive effect on cancer patients – BMJ
Remote Monitoring System Reduces Chemotherapy Symptom Burden – HealthDay
eSMART trial adds support for remote symptom monitoring in people with cancer – medwire News
Related:
Study: Cancer patients benefit from using automated device to manage their symptoms
Study: Web-Based Symptom Monitoring Increases Overall Survival in Lung Cancer
Commentary on Twitter
👇🏼 Results from an RCT, conducted at multiple centres across Europe, showing the benefits of remote patient monitoring and highlighting the vital role it will play in services going forward – congratulations @roma_maguire @Lisa_McCann_ and colleagues https://t.co/8zWrykJEjS
— Katie McMillan (@KathrynMc91) July 22, 2021
RCT: Dolutegravir or Darunavir in combination with Zidovudine or Tenofovir to treat HIV.
23 Jul, 2021 | 10:25h | UTCDolutegravir or Darunavir in Combination with Zidovudine or Tenofovir to Treat HIV – New England Journal of Medicine (link to abstract – $ for full-text)
Commentary: Dolutegravir Confirmed as Effective Second-Line HIV Therapy; Recycling Tenofovir Noninferior to Zidovudine – Medscape (free registration required)
RCT: Sintilimab plus a bevacizumab biosimilar versus sorafenib in unresectable hepatocellular carcinoma.
22 Jul, 2021 | 10:47h | UTCSintilimab plus a bevacizumab biosimilar (IBI305) versus sorafenib in unresectable hepatocellular carcinoma (ORIENT-32): a randomised, open-label, phase 2–3 study – The Lancet Oncology (link to abstract – $ for full-text)
Commentary on Twitter
In a phase III trial involving 571 pts with unresectable HCC, the anti-PD-1 mAb sintilimab + the bevacizumab biosimilar IBI305 improved PFS (median 4.6 vs 2.8 months with sorafenib; HR 0.56, P <0.0001) & OS (median NR vs 10.4 months; HR 0.57, P <0.0001), https://t.co/UF43FGdMMy
— NatureRevClinOncol (@NatRevClinOncol) June 22, 2021
RCT: Immediate oral refeeding in patients with mild and moderate acute pancreatitis.
22 Jul, 2021 | 10:32h | UTCImmediate Oral Refeeding in Patients With Mild and Moderate Acute Pancreatitis: A Multicenter, Randomized Controlled Trial (PADI trial) – Annals of Surgery (link to abstract – $ for full-text)
RCT: No benefit from platelet-rich plasma injection for patients with debilitating Achilles tendinopathy.
18 Jul, 2021 | 23:13h | UTCEffect of Platelet-Rich Plasma Injection vs Sham Injection on Tendon Dysfunction in Patients With Chronic Midportion Achilles Tendinopathy: A Randomized Clinical Trial – JAMA (free for a limited period)
Commentary: No benefit from PRP treatment for patients with debilitating Achilles tendon pain – University of Warwick
Commentary on Twitter
A single injection of platelet-rich plasma compared with a sham injection did not significantly reduce #Achillestendon dysfunction https://t.co/K4YKHSbxZY
— JAMA (@JAMA_current) July 13, 2021
RCT: Effect of neurofeedback facilitation on poststroke gait and balance recovery.
16 Jul, 2021 | 10:30h | UTCCommentary: Neurofeedback Facilitation Improves Gait and Balance in Post-Stroke Patients – BrainPost
RCT: Bamlanivimab plus Etesevimab reduce mortality and hospitalization in ambulatory patients with early Covid-19 (within 3 days of a positive test) who are at risk for clinical deterioration (i.e., older people, obese, diabetics, immunocompromised, with CV disease).
15 Jul, 2021 | 09:26h | UTCBamlanivimab plus Etesevimab in Mild or Moderate Covid-19 – New England Journal of Medicine
RCT: Intravitreal ranibizumab vs. aflibercept vs. bevacizumab for macular edema due to central retinal vein occlusion.
15 Jul, 2021 | 09:09h | UTC
Another RCT evaluating the efficacy and quality of life of antibiotic-only treatment of acute uncomplicated appendicitis.
13 Jul, 2021 | 09:33h | UTCA Randomized Clinical Trial Evaluating the Efficacy and Quality of Life of Antibiotic-only Treatment of Acute Uncomplicated Appendicitis: Results of the COMMA Trial – Annals of Surgery (link to abstract – $ for full-text)
Related: A Randomized trial comparing antibiotics with appendectomy for appendicitis AND Antibiotics alone for uncomplicated appendicitis: Oral Moxifloxacin almost as good as intravenous Ertapenem + oral Levofloxacin AND Observational study: 67.1% success rate with nonoperative management of children with uncomplicated appendicitis AND Randomized Trial: Quality of Life and Patient Satisfaction at 7-Year Follow-up of Antibiotic Therapy vs. Appendectomy for Uncomplicated Acute Appendicitis AND Meta-Analysis: Antibiotic Treatment vs. Appendectomy for Uncomplicated Acute Appendicitis in Adults and Children AND Nonoperative treatment for nonperforated appendicitis in children: a systematic review and meta-analysis – Pediatric Surgery International
Commentary on Twitter
The debate continues!
Another RCT comparing antibiotics to surgery for uncomplicated appendicitis – COMMA trial from 🇮🇪
Recurrence within 1-year : 25% after AB
Superior quality of life at 3 and 12mo after surgery.https://t.co/Yv51qpxchb
— Ville Sallinen (@villesallinen) July 11, 2021
RCT: Traditional plaster casting immobilization not superior to removable brace in adults with an ankle fracture.
12 Jul, 2021 | 01:22h | UTCNews release: Cast no better than brace for broken ankles – University of Warwick
RCT: MRI can cut overdiagnoses in prostate-cancer screening by half.
9 Jul, 2021 | 10:03h | UTCMRI-Targeted or Standard Biopsy in Prostate Cancer Screening – New England Journal of Medicine (link to abstract – $ for full-text)
News release: MRI can cut overdiagnoses in prostate-cancer screening by half – Karolinska Institutet
Related articles: RCT: MRI-targeted biopsy safely reduces the need for biopsy in more than one-third of men at risk for prostate cancer AND Meta-Analysis: Negative Predictive Value of MRI in the Detection of Clinically Significant Prostate Cancer AND Study: MRI-Targeted, Systematic, and Combined Biopsy for Prostate Cancer Diagnosis AND Review: The Use of MRI and PET Imaging Studies for Prostate Cancer Management AND Meta-Analysis: MRI plus Targeted Biopsy vs. Systematic Biopsy Alone for the Diagnosis of Prostate Cancer AND Cochrane Review: MRI Pathway vs. Systematic Biopsy for Detecting Prostate Cancer AND Meta-analysis: Clinical Utility of MRI in the Decision-making Process Before Radical Prostatectomy AND Research: Biparametric MRI (simpler, faster) May Be Used to Exclude Aggressive Disease and Avoid Unnecessary Biopsies in Men with Clinical Suspicion of Prostate Cancer AND Research: MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis AND Multiparametric MRI in the Detection of Clinically Significant Prostate Cancer
RCT: Cardiovascular and renal outcomes with Efpeglenatide (a GLP-1 receptor agonist) in Type 2 Diabetes.
7 Jul, 2021 | 08:45h | UTC
RCT: Daratumumab-based treatment for immunoglobulin light-chain amyloidosis.
7 Jul, 2021 | 08:44h | UTC
RCT: Similar long-term survival after combined epidural–general anesthesia vs. general anesthesia alone.
7 Jul, 2021 | 08:39h | UTC
Commentary on Twitter
In elderly patients having major thoracic and abdominal surgery, combined epidural–general anesthesia with epidural analgesia did not improve overall or cancer-specific long-term mortality. https://t.co/rFyvUYO2LX
— Anesthesiology (@_Anesthesiology) June 21, 2021
RCT: Awake prone positioning in patients with hypoxemic respiratory failure due to COVID-19 – no difference in intubation rates compared to standard care.
5 Jul, 2021 | 02:24h | UTC
Single-center, open-label RCT: Stimulant and osmotic laxatives after colorectal surgery results in earlier recovery of gastrointestinal function and reduces the incidence of prolonged postoperative ileus, without effects in the duration of hospital day or 30-day postoperative complications.
5 Jul, 2021 | 01:26h | UTCImpact of STIMUlant and osmotic LAXatives (STIMULAX trial) on gastrointestinal recovery after colorectal surgery: randomized clinical trial – British Journal of Surgery (link to abstract – $ for full-text)
RCT: Prophylactic manual rotation of occiput posterior and transverse positions was associated with a reduced risk of operative delivery.
5 Jul, 2021 | 01:28h | UTCProphylactic manual rotation of occiput posterior and transverse positions to decrease operative delivery: the PROPOP randomized clinical trial – American Journal of Obstetrics & Gynecology (link to abstract – $ for full-text)
RCT: Safety and efficacy of occipital nerve stimulation for attack prevention in medically intractable chronic cluster headache.
5 Jul, 2021 | 01:24h | UTCSafety and efficacy of occipital nerve stimulation for attack prevention in medically intractable chronic cluster headache (ICON): a randomised, double-blind, multicentre, phase 3, electrical dose-controlled trial – The Lancet Neurology (link to abstract – $ for full-text)
Commentary: Nerve stimulation effective in patients with untreatable cluster headaches – Leiden University