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Randomized Trials

RCT | Epirubicin + Paclitaxel vs Epirubicin and Cyclophosphamide followed by Paclitaxel in operable ERBB2-negative and lymph node–positive BC

27 Feb, 2023 | 12:55h | UTC

Effect of Epirubicin Plus Paclitaxel vs Epirubicin and Cyclophosphamide Followed by Paclitaxel on Disease-Free Survival Among Patients With Operable ERBB2-Negative and Lymph Node–Positive Breast Cancer: A Randomized Clinical Trial – JAMA Network Open

 

Commentary on Twitter

 

RCT | Isolated ambulatory phlebectomy vs. saphenous thermal ablation with concomitant phlebectomy in saphenous trunk and tributary incompetence

27 Feb, 2023 | 12:39h | UTC

A randomized clinical trial of isolated ambulatory phlebectomy versus saphenous thermal ablation with concomitant phlebectomy (SAPTAP Trial) – British Journal of Surgery

 

RCT | Aspirin discontinuation at 24 to 28 weeks’ gestation in pregnancies at high risk of preterm preeclampsia

24 Feb, 2023 | 13:56h | UTC

Article: Aspirin Discontinuation at 24 to 28 Weeks’ Gestation in Pregnancies at High Risk of Preterm Preeclampsia: A Randomized Clinical Trial – JAMA (free for a limited period)

Editorial: Biomarkers and the Risk of Preeclampsia – JAMA (free for a limited period)

 

Commentary on Twitter

 

RCT | Laparoscopic proximal gastrectomy with double-tract reconstruction vs. total gastrectomy in upper-third early gastric cancer

23 Feb, 2023 | 13:29h | UTC

Summary: This randomized trial examined whether laparoscopic proximal gastrectomy with double-tract reconstruction (LPG-DTR) is a superior surgical treatment compared to laparoscopic total gastrectomy (LTG) for patients with early gastric cancer (GC) in the upper third of the stomach. The study found that LPG-DTR resulted in significantly decreased amounts of vitamin B12 supplementation, but no significant difference in hemoglobin change compared to LTG. The study also found no difference in complication rates or overall and disease-free survival rates between the two groups. The study suggests that LPG-DTR may be a function-preserving procedure for the treatment of patients with upper-third early GC.

Article: Effect of Laparoscopic Proximal Gastrectomy With Double-Tract Reconstruction vs Total Gastrectomy on Hemoglobin Level and Vitamin B12 Supplementation in Upper-Third Early Gastric Cancer: A Randomized Clinical Trial – JAMA Network Open

 

Commentary on Twitter

 

RCT | An initial 8-week bedaquiline-linezolid regimen shows promise for the treatment of rifampin-susceptible tuberculosis

22 Feb, 2023 | 12:50h | UTC

Summary: This randomized trial compared a standard 6-month rifampin-based tuberculosis treatment to a strategy that involved shorter initial treatment with extended therapy for persistent disease, monitoring, and retreatment for relapse. The results showed that the strategy involving an 8-week bedaquiline-linezolid regimen was noninferior to standard treatment for clinical outcomes. The experimental strategy was associated with a shorter total duration of treatment with no evident safety concerns.

Article: Treatment Strategy for Rifampin-Susceptible Tuberculosis – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary: Shorter drug regimen shows promise in TB trial – CIDRAP

 

RCT | Temporary cessation vs. continuation of first-line tyrosine kinase inhibitor in advanced clear cell renal cell carcinoma

22 Feb, 2023 | 12:40h | UTC

Summary: The STAR trial investigated whether a tyrosine kinase inhibitor drug-free interval strategy was non-inferior to a conventional continuation strategy for first-line treatment of advanced clear cell renal cell carcinoma. All patients received standard dosing schedules of oral sunitinib (50 mg per day) or oral pazopanib (800 mg per day) for 24 weeks before moving into their randomly allocated group. Although non-inferiority could not be concluded for the primary endpoint of overall survival, temporary treatment cessation was found to preserve quality of life and was cost-effective. Therefore, planned breaks in tyrosine kinase inhibitor treatment represent a reasonable option for selected patients with renal cell carcinoma, providing potential lifestyle and health economic benefits. The study provides a rationale for further exploration of treatment breaks in patients with other cancers.

Article: Temporary treatment cessation versus continuation of first-line tyrosine kinase inhibitor in patients with advanced clear cell renal cell carcinoma (STAR): an open-label, non-inferiority, randomised, controlled, phase 2/3 trial – The Lancet Oncology

 

Commentary on Twitter

 

RCT | Cold snare polypectomy reduces bleeding compared to hot snare polypectomy

22 Feb, 2023 | 12:34h | UTC

Cold Versus Hot Snare Polypectomy for Small Colorectal Polyps: A Pragmatic Randomized Controlled Trial – Annals of Internal Medicine (link to abstract – $ for full-text)

News Release: Cold snare polypectomy significantly reduces bleeding risk compared to hot snare polypectomy – Science News Net

 

Phase 2b RCT | Effects of OPT-302, a VEGF-C/D inhibitor for neovascular age-related macular degeneration

22 Feb, 2023 | 12:21h | UTC

A randomized controlled trial of OPT-302, a VEGF-C/D inhibitor for neovascular age-related macular degeneration – Ophthalmology

 

RCT | Breast-conserving surgery without irradiation may be an option for older patients with early breast cancer

17 Feb, 2023 | 13:25h | UTC

Summary: The article reports a phase 3 randomized trial that investigated the efficacy of omitting irradiation after breast-conserving surgery in women aged 65 years or older with hormone receptor-positive, node-negative, T1 or T2 primary breast cancer, and tumors ≤3 cm in the largest dimension, who received adjuvant endocrine therapy. A total of 1326 women were enrolled, with 658 receiving whole-breast irradiation and 668 receiving no irradiation. The results showed that the omission of radiotherapy led to an increased incidence of local breast cancer recurrence but had no negative effect on distant recurrence as the first event or overall survival. The study suggests that omission of radiotherapy could be a viable treatment option for older women with low-risk, hormone receptor–positive early breast cancer who receive adjuvant endocrine therapy.*

Article: Breast-Conserving Surgery with or without Irradiation in Early Breast Cancer – New England Journal of Medicine (link to abstract – $ for full-text)

Commentaries:

For many older breast cancer patients, study finds radiation doesn’t affect survival – STAT

Do Older Patients Need Radiation Rx After Breast Cancer Surgery? – HealthDay

 

*Note: This summary was created through the collaboration of a medical editor and ChatGPT.

 

RCT | Home high-flow nasal cannula oxygen therapy for stable hypercapnic COPD

17 Feb, 2023 | 12:53h | UTC

Home High-Flow Nasal Cannula Oxygen Therapy for Stable Hypercapnic COPD: A Randomized Clinical Trial – American Journal of Respiratory and Critical Care Medicine

 

10-year follow-up on preterm prelabor rupture of membranes: induced labor vs. expectant management childhood outcomes

16 Feb, 2023 | 15:05h | UTC

Summary: This study aimed to compare the long-term outcomes of children born after singleton pregnancies complicated by preterm prelabor rupture of membranes and managed by induction of labor vs. expectant management in RCTs undergone between 2007 and 2011. The study assessed the children’s cognition, motor function, and behavior as the primary outcomes. It found that expectant management did not improve long-term outcomes compared to induction of labor for children born after pregnancies with preterm prelabor (between 34 0/7 and 36 6/7 weeks of pregnancy) rupture of membranes. The confidence in the results of this follow-up study is diminished because only 35% of the children who participated in the original trials participated in the follow-up study.

Article: Childhood outcomes after induction of labor or expectant management for preterm prelabor rupture of membranes: a 10-year follow-up of the PPROMEXIL trials – American Journal of Obstetrics & Gynecology

 

*Note: This summary was created through the collaboration of a medical editor and ChatGPT.

 

RCT | Pembrolizumab vs. placebo as second-line therapy in patients from Asia with advanced hepatocellular carcinoma

16 Feb, 2023 | 14:40h | UTC

Pembrolizumab Versus Placebo as Second-Line Therapy in Patients From Asia With Advanced Hepatocellular Carcinoma: A Randomized, Double-Blind, Phase III Trial – Journal of Clinical Oncology

Commentary: KEYNOTE-394: Pembrolizumab as Second-Line Therapy in Asian Patients With Advanced HCC – The ASCO Post

 

RCT | Effect of low-concentration atropine eyedrops vs. placebo on myopia incidence in children

15 Feb, 2023 | 16:09h | UTC

Summary: The study aimed to evaluate the efficacy of low-concentration atropine eyedrops at 0.05% and 0.01% concentration for delaying the onset of myopia in children. The randomized, placebo-controlled, double-masked trial enrolled 474 nonmyopic children aged 4 through 9 years. Participants were assigned to 0.05% atropine, 0.01% atropine, and placebo groups and had eyedrops applied once nightly in both eyes over 2 years. The results showed that the 0.05% atropine eyedrops resulted in a significantly lower incidence of myopia and a lower percentage of participants with fast myopic shift at 2 years compared with placebo. However, there was no significant difference between 0.01% atropine and placebo. More research is necessary to replicate the results, determine whether this approach delays or prevents myopia, and evaluate its long-term safety.*

Article: Effect of Low-Concentration Atropine Eyedrops vs Placebo on Myopia Incidence in Children: The LAMP2 Randomized Clinical Trial – JAMA (free for a limited period)

Editorial: Delaying the Onset of Nearsightedness – JAMA (free for a limited period)

Commentaries:

Atropine Eyedrops Associated With Lower Incidence of Myopia, Myopic Shift – AJMC

Low-Concentration Atropine Eyedrops Linked to Lower Myopia Incidence in Children – HCP Live

0.05 Percent Atropine Eye Drops Result in Lower Incidence of Myopia – HealthDay

 

Commentary on Twitter

 

*Note: This summary was created through the collaboration of a medical editor and ChatGPT.

 

RCT | Preoperative MRI in breast cancer did not influence local relapse-free survival, overall survival, or reoperation rates

15 Feb, 2023 | 15:57h | UTC

Summary: This study investigated the impact of preoperative magnetic resonance imaging (MRI) on survival and surgical outcomes in conservative surgery for breast cancer. The randomized controlled trial included female participants with stage 0-III breast cancer, eligible for breast-conserving surgery. The study found that preoperative MRI increased the rate of mastectomies by 8% compared to routine radiologic exams using mammography and ultrasound. However, preoperative MRI did not impact the rates of local relapse-free survival, overall survival, or reoperation.*

Article: Effects of preoperative magnetic resonance image on survival rates and surgical planning in breast cancer conservative surgery: randomized controlled trial (BREAST-MRI trial) – Breast Cancer Research and Treatment

 

*Note: This summary was created through the collaboration of a medical editor and ChatGPT.

 

Design, power, and alpha levels in randomized phase II oncology trials

14 Feb, 2023 | 10:40h | UTC

Summary: This study examined the methodology, reporting, and bias in the interpretation of outcomes in randomized phase II oncology trials. It found that many trials failed to report essential data for determining sample size calculations, did not use a comparator to determine efficacy, and had positive conclusions even though the results were indeterminate or the primary endpoint was not met. The study concluded that phase II trials need to adhere to the same reporting standards and be interpreted in the context of their primary endpoint and endpoints important for the patient.

(By ChatGPT, reviewed and edited)

 

Article: Design, power, and alpha levels in randomized phase II oncology trials – ESMO Open

 

RCT | Azithromycin reduces the risk of maternal sepsis or death in women planning a vaginal birth

13 Feb, 2023 | 13:02h | UTC

Azithromycin to Prevent Sepsis or Death in Women Planning a Vaginal Birth – New England Journal of Medicine (link to abstract – $ for full-text)

News Release: Single-dose antibiotic prevents maternal sepsis and death – NIH News

Commentaries:

In large study, a single antibiotic dose slashed rate of sepsis in childbirth – STAT

Dose of azithromycin found to cut risk of maternal death, sepsis in childbirth – CIDRAP

Single dose of the antibiotic azithromycin decreases sepsis and death risk during childbirth – News Medical/ University of Virginia Health System

 

RCTs | Endovascular therapy improves functional outcomes in large ischemic strokes, but increases bleeding and vascular complications

13 Feb, 2023 | 13:00h | UTC

Study 1: Trial of Endovascular Thrombectomy for Large Ischemic Strokes – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary: Major international study finds thrombectomy highly effective treatment for large strokes – University Hospitals Cleveland Medical Center

Study 2: Trial of Endovascular Therapy for Acute Ischemic Stroke with Large Infarct – New England Journal of Medicine (link to abstract – $ for full-text)

 

RCT | A deprescribing intervention reduced medication burden among older adults in post-acute care

13 Feb, 2023 | 12:50h | UTC

Deprescribing Medications Among Older Adults From End of Hospitalization Through Postacute Care: A Shed-MEDS Randomized Clinical Trial – JAMA Internal Medicine (free for a limited period)

Related:

Achieving sustainable healthcare through deprescribing of unnecessary medications: making sense of the evidence – Cochrane Library

Deprescribing medicines in older people living with multimorbidity and polypharmacy: the TAILOR evidence synthesis – Health Technology Assessment

Barriers and facilitators to deprescribing of cardiovascular medications: a systematic review – BMJ Open

A National Modified Delphi Consensus Process to Prioritize Experiences and Interventions for Antipsychotic Medication Deprescribing Among Adult Patients With Critical Illness – Critical Care Explorations

Deprescribing proton pump inhibitors – Australian Journal of General Practice

Medication reviews and deprescribing as a single intervention in falls prevention: a systematic review and meta-analysis – Age and Ageing

Optimizing Medication Use in Older Adults With Rheumatic Musculoskeletal Diseases: Deprescribing as an Approach When Less May Be More – ACP Open Rheumatology

Facing the challenge of polypharmacy when prescribing for older people with cardiovascular disease. A review by the European Society of Cardiology Working Group on Cardiovascular Pharmacotherapy – European Heart Journal – Cardiovascular Pharmacotherapy

Deprescribing in Older Adults with Cardiovascular Disease – Journal of the American College of Cardiology

Multimorbidity in Older Adults with Cardiovascular Disease – American College of Cardiology, Latest in Cardiology

Antihypertensive Deprescribing in Older Adults: a Practical Guide – Current Hypertension Reports

How-to guide for medication reviews in older adults with cancer: A Young International Society of Geriatric Oncology and Nursing & Allied Health Interest Group initiative – Journal of Geriatric Oncology

Deprescribing in Palliative Cancer Care – Life

Less is More: Deprescribing Medications in Older Adults with Kidney Disease: A Review – Kidney360

Process evaluation of implementation strategies to reduce potentially inappropriate medication prescribing in older population: A scoping review – Research in Social and Administrative Pharmacy

AGA Clinical Practice Update on De-Prescribing of Proton Pump Inhibitors: Expert Review – Gastroenterology

Development of a Metric to Detect and Decrease Low-Value Prescribing in Older Adults – JAMA Network Open

The MedSafer Study—Electronic Decision Support for Deprescribing in Hospitalized Older Adults: A Cluster Randomized Clinical Trial – JAMA Internal Medicine

Quantifying Anticholinergic Burden and Sedative Load in Older Adults with Polypharmacy: A Systematic Review of Risk Scales and Models – Drugs & Aging

Deprescribing in palliative patients with cancer: a concise review of tools and guidelines – Supportive Care in Cancer

Prescribing practices, patterns, and potential harms in patients receiving palliative care: A systematic scoping review – Exploratory Research in Clinical and Social Pharmacy

A narrative review of evidence to guide deprescribing among older adults – Journal of General and Family Medicine

Polypharmacy, inappropriate prescribing, and deprescribing in older people: through a sex and gender lens – The Lancet Health Longevity

Polypharmacy Management in Older Patients – Mayo Clinic Proceedings

Psychopharmacological Treatment in Older People: Avoiding Drug Interactions and Polypharmacy – Deutsches Ärzteblatt international

Eliminating Medication Overload: A National Action Plan – Lown Institute

International Group for Reducing Inappropriate Medication Use & Polypharmacy (IGRIMUP): Position Statement and 10 Recommendations for Action – Drugs & Aging

Common ED Medication Errors: Polypharmacy – emDocs

Current and future perspectives on the management of polypharmacy – BMC Family Practice

Routine deprescribing of chronic medications to combat polypharmacy – Therapeutic Advances in Drug Safety

Polypharmacy—an Upward Trend with Unpredictable Effects – Deutsches Ärzteblatt international

Clinical Consequences of Polypharmacy in Elderly – Expert Opinion on Drug Safety

 

Commentary on Twitter

 

Phase 2 RCT | Effects of Difelikefalin in notalgia paresthetica

13 Feb, 2023 | 12:42h | UTC

Phase 2 Trial of Difelikefalin in Notalgia Paresthetica – New England Journal of Medicine (link to abstract – $ for full-text)

Commentaries:

Phase 2 Trial Finds Difelikefalin Could Prove Useful in Notalgia Paresthetica – HCP Live

Difelikefalin Improves Itch Intensity in Notalgia Paresthetica – HealthDay

 

Commentary on Twitter

 

RCT | Preliminary study on the effects of low-dose colchicine in patients undergoing non-CABG cardiac surgery

13 Feb, 2023 | 12:43h | UTC

The low-dose colchicine in patients after non-CABG cardiac surgery: a randomized controlled trial – Critical Care

 

Commentary on Twitter

 

RCT | Ide-cel (a CAR-T cell treatment) vs. standard regimens in relapsed and refractory multiple myeloma

13 Feb, 2023 | 12:41h | UTC

Ide-cel or Standard Regimens in Relapsed and Refractory Multiple Myeloma – New England Journal of Medicine (link to abstract – $ for full-text)

Commentaries:

Ide-Cel Beneficial in Relapsed, Refractory Multiple Myeloma – HealthDay

Ide-cel Improves PFS vs SOC in Relapsed/Refractory Multiple Myeloma – OncLive

 

RCT | Allo-HCT vs. standard consolidation chemotherapy in patients with intermediate-risk AML

13 Feb, 2023 | 12:40h | UTC

Allogeneic Hematopoietic Cell Transplantation vs Standard Consolidation Chemotherapy in Patients With Intermediate-Risk Acute Myeloid Leukemia: A Randomized Clinical Trial – JAMA Oncology (free for a limited period)

Commentary: Allo-HCT Not Linked With Better OS vs Consolidation Chemotherapy in AML Patients in Complete Remission – AJMC

 

Commentary on Twitter

 

RCT | Argatroban plus Alteplase not better than Alteplase alone in patients with acute ischemic stroke

10 Feb, 2023 | 13:59h | UTC

Effect of Argatroban Plus Intravenous Alteplase vs Intravenous Alteplase Alone on Neurologic Function in Patients With Acute Ischemic Stroke: The ARAIS Randomized Clinical Trial – JAMA (free for a limited period)

 

Commentary on Twitter

 

RCT | Efficacy and safety of bimekizumab in axial spondyloarthritis

10 Feb, 2023 | 13:42h | UTC

Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomised controlled trials – Annals of the Rheumatic Diseases

Related:

Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE) – The Lancet

Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL) – The Lancet

Bimekizumab versus Secukinumab in Plaque Psoriasis – New England Journal of Medicine

Bimekizumab versus Adalimumab in Plaque Psoriasis – New England Journal of Medicine

 

RCT | Genicular nerve block vs. intra-articular triamcinolone in juvenile idiopathic arthritis

10 Feb, 2023 | 13:36h | UTC

Genicular nerve block in juvenile idiopathic arthritis: a randomized clinical trial – Clinical Rheumatology

 

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