Randomized Trials
RCT: Novavax vaccine conferred 89.7% protection against symptomatic SARS-CoV-2 infection and 100% protection against hospitalizations or deaths.
1 Jul, 2021 | 09:59h | UTCSafety and Efficacy of NVX-CoV2373 Covid-19 Vaccine – New England Journal of Medicine
Audio interview: Audio Interview: Another New Covid-19 Vaccine – New England Journal of Medicine
Related: Opinion | The mRNA vaccines are extraordinary, but Novavax is even better
RCT: Similar outcomes with 5 vs. 2 years of zoledronate treatment following adjuvant chemotherapy in early breast cancer.
1 Jul, 2021 | 09:50h | UTCOriginal Study: Prognosis of Patients With Early Breast Cancer Receiving 5 Years vs 2 Years of Adjuvant Bisphosphonate Treatment: A Phase 3 Randomized Clinical Trial – JAMA Oncology (link to abstract – $ for full-text)
RCT: Similar outcomes with mycophenolate mofetil vs. azathioprine in kidney transplant recipients on steroid-free, low-dose cyclosporine immunosuppression.
29 Jun, 2021 | 09:50h | UTC
Guidelines for reporting trial protocols and completed trials modified due to the COVID-19 pandemic and other extenuating circumstances: The CONSERVE 2021 Statement.
22 Jun, 2021 | 10:04h | UTC
Commentaries on Twitter
CONSERVE offers guidance that could help improve the transparency, quality, and completeness of reporting important modifications to trials in extenuating circumstances https://t.co/IiWgs7dtpQ
— JAMA (@JAMA_current) June 21, 2021
https://twitter.com/DrSherryPagoto/status/1407102563191824384
RCT: Routine use of prophylactic postoperative continuous positive airway pressure (CPAP) does not prevent pneumonia, re-intubation, and death after major abdominal surgery.
21 Jun, 2021 | 08:32h | UTCPostoperative continuous positive airway pressure to prevent pneumonia, re-intubation, and death after major abdominal surgery (PRISM): a multicentre, open-label, randomised, phase 3 trial – The Lancet Respiratory Medicine (link to abstract – $ for full-text)
Commentary on Twitter (thread – click for more)
Published today in @LancetRespirMed is the final report of @prismtrial, an international multi-centre phase-3 randomised trial of routine postoperative CPAP to prevent pneumonia, re-intubation & death after major abdominal surgery https://t.co/e09pSTi2sa @rupert_pearse @QMULWHRI
— Tom Abbott (@_tomabbott) June 19, 2021
RCT: Effects of intravenous Eptinezumab vs. placebo on headache pain and most bothersome symptom when initiated during a migraine attack.
18 Jun, 2021 | 08:16h | UTCEffects of Intraven.ous Eptinezumab vs Placebo on Headache Pain and Most Bothersome Symptom When Initiated During a Migraine Attack: A Randomized Clinical Trial – JAMA (free for a limited period)
Editorial: Acute Treatment for Migraine: Contemporary Treatments and Future Directions (free for a limited period)
Commentary: Migraine Prevention Drug Eptinezumab Shows Efficacy in Treating Acute Attacks – Physician’s Weekly
Commentary on Twitter (thread – click for more)
Science marches breathlessly forward – or, at least tries to expand its indication.
Anti–calcitonin gene-related peptide antibody infusion, again, vs. placebo.
— Ryan Radecki, MD MS (@emlitofnote) June 17, 2021
[Preprint] RECOVERY trial finds Regeneron’s monoclonal antibody combination reduces deaths for hospitalized COVID-19 patients who have not mounted their own immune response.
17 Jun, 2021 | 09:55h | UTCOriginal study (preprint): Casirivimab and imdevimab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial – medRxiv
Commentaries: Monoclonal antibodies cut risk of dying from COVID-19—but only in some patients – Science AND Antibody combo cuts COVID deaths by 20% in very ill seronegative patients – CIDRAP AND Regeneron antibody saves lives in some hospitalized Covid patients, study finds – STAT AND Expert reaction to press release from the RECOVERY trial reporting that Regeneron’s monoclonal antibody combination reduces deaths for hospitalised COVID-19 patients who have not mounted their own immune response – Science Media Centre
Commentary on Twitter
RECOVERY Pre-print:
In patients hospitalised with COVID-19 but no natural antibody response, monoclonal antibody infusion:
– reduced mortality
– increased speed of discharge
– reduced progression to invasive mechanical ventilation or deathhttps://t.co/rpDk4eUhmm pic.twitter.com/wXegKcDZg8— Martin Landray (@MartinLandray) June 16, 2021
RCT: In patients with coma after out-of-hospital cardiac arrest, targeted hypothermia did not improve outcomes.
17 Jun, 2021 | 09:39h | UTCNews release: Induced hypothermia after cardiac arrest did not improve survival – Lund University
Infographic: The TTM2 Trial – CanadianEM
Commentary: Hypothermia or Normothermia after Cardiac Arrest – NEJM Resident 360
Video: TTM2 Results Presentation Livestream – Critical Care Reviews
Commentary on Twitter (thread – click for more)
The #TTM2trial was published today in the @NEJM https://t.co/jccLB1MO64
Here’s a summary of what we did, what I think the trial means, and what next.@ttm2trial @nielsen_niklas @CritCareReviews @NEJM— Paul Young (@DogICUma) June 16, 2021
Randomized, sham-controlled pilot study: percutaneous peripheral nerve stimulation (neuromodulation) for postoperative pain.
16 Jun, 2021 | 08:17h | UTCCommentary: Peripheral Nerve Stimulation May Cut Pain After Orthopedic Surgery – HealthDay
RCT: No difference in 30-day mortality with discontinuation vs. continuation of renin-angiotensin-system inhibitors in patients with COVID-19, but secondary and explorative analysis showed discontinuation of RAS-inhibition may lead to a faster and better recovery.
14 Jun, 2021 | 08:47h | UTCEditorial: RAS inhibition and COVID-19: more questions than answers?
Related randomized trials showing no benefit from discontinuation: Randomized trial: No benefit from discontinuing ACE Inhibitors and ARBs in patients admitted with COVID-19 AND Randomized trial: Renin–angiotensin system inhibitors can be safely continued in patients admitted to hospital with COVID-19
RCT: Single-day low-residue diet prior to colonoscopy demonstrates improved bowel preparation quality and patient tolerance over clear liquid diet
14 Jun, 2021 | 08:26h | UTC
RCT: Vaginal administration of misoprostol is superior to buccal administration of misoprostol along with a Foley catheter for induction of labor.
9 Jun, 2021 | 08:11h | UTCBuccal vs vaginal misoprostol combined with Foley catheter for cervical ripening at term (the BEGIN trial): a randomized controlled trial – American Journal of Obstetrics & Gynecology (link to abstract – $ for full-text)
Commentary on Twitter
https://twitter.com/AJOG_thegray/status/1393529144395374592
RCT: Low tidal volume ventilation is not superior to no ventilation during cardiopulmonary bypass in heart surgery.
8 Jun, 2021 | 09:16h | UTCLow Tidal Volume Mechanical Ventilation Against No Ventilation During Cardiopulmonary Bypass in Heart Surgery (MECANO): A Randomized Controlled Trial – CHEST (link to abstract – $ for full-text)
RCT: Early, intensive mobilization poststroke may harm patients.
6 Jun, 2021 | 23:45h | UTCFatal and Nonfatal Events Within 14 days After Early, Intensive Mobilization Poststroke – Neurology
RCT: No benefit from posterior quadratus lumborum block in total hip arthroplasty.
6 Jun, 2021 | 23:35h | UTC
Commentary on Twitter
In the context of a multimodal postoperative analgesic strategy, providing a quadratus lumborum block using ropivacaine resulted in no less morphine consumption or pain in the first 24 postoperative hours compared to saline injection #visualabstract https://t.co/cvxuQ9AQPQ pic.twitter.com/HP5EwrKagx
— Anesthesiology (@_Anesthesiology) April 20, 2021
RCT: Among patients with Type 2 diabetes treated with basal insulin with poor glycemic control (mean baseline HbA1c level = 9.1%), continuous glucose monitoring reduced HbA1c level by 0.4% compared to usual care (8.0% and 8.4%). Patient engagement (i.e., adherence, diet, physical activity in response to CGM readings) was the most likely source of improved glycemic control.
3 Jun, 2021 | 10:54h | UTCEditorial: Broadening Access to Continuous Glucose Monitoring for Patients With Type 2 Diabetes – JAMA
Commentary: Studies support wider CGM access in type 2 diabetes – medwire News
Commentary on Twitter
Continuous glucose monitoring resulted in better glycemic control compared with blood glucose meter monitoring in adults with poorly controlled type 2 diabetes treated with basal insulin without prandial insulin https://t.co/D0y7B8JsJE
— JAMA (@JAMA_current) June 2, 2021
RCT: Adjuvant Nivolumab vs. Placebo in Muscle-Invasive Urothelial Carcinoma.
3 Jun, 2021 | 10:36h | UTC
RCT: Pfizer-BioNTech Covid-19 vaccine shows 100% efficacy in adolescents – mainly transient mild-to-moderate reactogenicity was frequently observed, such as injection-site pain (in 79 to 86% of participants), fatigue (in 60 to 66%), and headache (in 55 to 65%).
28 May, 2021 | 08:24h | UTC
Commentary on Twitter
The 12-15 year-olds mRNA vaccine randomized, placebo-controlled clinical trial is published @NEJM today [@BioNTech_Group/@Pfizer]https://t.co/7GlgC9xdd0
—100% efficacy (95% CI 75,100)
—1.8 X higher levels of neutralizing antibodies than 16-25 yr olds
—very good safety profile pic.twitter.com/hQzkpuA5Nu— Eric Topol (@EricTopol) May 27, 2021
RCT: 2 inactivated SARS-CoV-2 vaccines show efficacy of 72.8% and 78.1% on symptomatic COVID-19 infection in adults.
27 May, 2021 | 08:38h | UTCCommentary: China’s Sinopharm Publishes Awaited Covid Vaccine Study Details – Bloomberg
Commentary on Twitter (thread – click for more)
https://twitter.com/hildabast/status/1397678056270012419
RCT: Among patients with prosthetic joint infection, antibiotic therapy for 6 weeks was NOT shown to be noninferior to antibiotic therapy for 12 weeks and resulted in a higher percentage of patients with unfavorable outcomes.
27 May, 2021 | 08:20h | UTCAntibiotic Therapy for 6 or 12 Weeks for Prosthetic Joint Infection – New England Journal of Medicine (link to abstract – $ for full-text)
RCT: First-attempt intubation success is increased with the use an endotracheal tube + stylet vs. an endotracheal tube alone.
27 May, 2021 | 08:16h | UTC
Commentary on Twitter
Endotracheal tube + stylet vs tube alone, RCT
➡️999 critically ill adults
➡️significantly higher first-attempt intubation success 78.2% vs 71.5%
➡️related complications 38.7% vs 40.2%
➡️similar rate of serious adverse events (traumatic injuries) 4% vs 3.6%https://t.co/EQ6sqS75hN pic.twitter.com/zF9PguNCSK— Intensive Care Medicine (@yourICM) May 26, 2021
RCT: Immediate “kangaroo mother care” improves survival in infants with low birth weight compared to conventional care with “kangaroo mother care” initiated after stabilization.
27 May, 2021 | 08:18h | UTCCommentary: Immediate skin-to-skin contact after birth improves survival of pre-term babies – Karolisnka Institutet
Related: RCT: Community-initiated kangaroo mother care reduced the risk of moderate-to-severe maternal postpartum depressive symptoms among mothers of low-birth-weight infants in low-income areas in India AND WHO: New research highlights risks of separating newborns from mothers during COVID-19 pandemic AND Randomized Trial: Kangaroo Mother Care Improves Survival of Infants with Low Birthweight
[Preprint] Meta-analysis of RCT: Ivermectin for the treatment of COVID-19 – no effect on all-cause mortality, length of stay, or viral clearance
26 May, 2021 | 08:41h | UTC
Commentary on Twitter
🆕💥💥Preprint
Ivermectin for the treatment of #COVID19 : A systematic review & meta-analysis of RCTs
10 RCTs
1173 patients
8 RCTs➡️ Mild
1 RCT ➡️ Moderate
1 RCT➡️ Mild& mod
Ivermectin did not reduce all-cause mortality,length of stay or viral clearance https://t.co/QMx0wlfS8f pic.twitter.com/6yddqwqPF6— Antibiotic Steward Bassam Ghanem 🅱️C🆔🅿️🌟 (@ABsteward) May 25, 2021
RCT: Continuous infusion of 20% hypertonic saline does not improve neurological outcomes in patients with traumatic brain injury
26 May, 2021 | 08:22h | UTCEffect of Continuous Infusion of Hypertonic Saline vs Standard Care on 6-Month Neurological Outcomes in Patients With Traumatic Brain Injury: The COBI Randomized Clinical Trial – JAMA (free for a limited period)
Commentary on Twitter
Among patients with moderate to severe traumatic brain injury, treatment with continuous infusion of 20% hypertonic saline compared with standard care did not result in a significantly better neurological status at 6 months https://t.co/zyPhO0Y2Yy
— JAMA (@JAMA_current) May 25, 2021
RCT: Manual rotation of occiput posterior fetal positions at the start of the second stage of labor does not increase the rate of vaginal delivery without instrumental assistance.
26 May, 2021 | 08:17h | UTC