Daily Archives: March 16, 2023

FDA issues new information on cases of squamous cell carcinoma and lymphomas around breast implants

16 Mar, 2023 | 13:28h | UTC

Summary: The US Food and Drug Administration (FDA) has provided an update on reports of squamous cell carcinoma (SCC) in the scar tissue (capsule) that forms around breast implants. The FDA is aware of 19 cases of SCC in the capsule around the breast implant from published literature, including 3 reports of deaths from the disease.

While the FDA continues to believe that occurrences of SCC in the capsule around the breast implant may be rare, the cause, incidence, and risk factors remain unknown. Health care providers and people who have or are considering breast implants should be aware that cases of SCC and various lymphomas in the capsule around the breast implant have been reported to the FDA and in the literature.

The FDA continues to ask health care providers and people with breast implants to report cases of SCC, lymphomas, or any other cancers around breast implants.

FDA Safety Communication: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants – FDA Safety Communication – U.S. Food & Drug Administration

Commentary: FDA Issues Safety Communication on Reports of Squamous Cell Carcinoma in the Capsule Around Breast Implants – The ASCO Post

Study: Long-term Outcomes of Silicone Breast Implants

RCT | Pre-hospital rule-out of NSTE-ACS by ambulance paramedics with point-of-care troponin is feasible and cost-saving

16 Mar, 2023 | 13:27h | UTC

Summary: Using a point-of-care (POC) troponin measurement, this randomized trial in the Netherlands assessed the safety and healthcare costs of a pre-hospital rule-out strategy for patients with suspected non-ST-segment elevation acute coronary syndrome (NSTE-ACS).

The study included only patients considered at low risk with a HEAR (History, ECG, Age, Risk factors) score ≤3. A total of 863 low-risk participants were randomized to direct transfer to the ED or a pre-hospital rule-out strategy with POC troponin measurement.

The trial found that pre-hospital rule-out of NSTE-ACS in low-risk patients using a single POC troponin measurement is feasible, significantly reduces healthcare costs, and is associated with a low incidence of major adverse cardiac events.

The HEAR score, combined with a POC troponin measurement by ambulance paramedics, accurately identifies low-risk patients for whom ED evaluation is unnecessary. Implementing this pre-hospital rule-out strategy in low-risk patients could significantly reduce healthcare costs through more efficient use of ambulance services and fewer ED visits. It is worth noting, however, that further studies in other localities are necessary before the widespread use of this strategy can be implemented.

Article: Rule-out of non-ST-segment elevation acute coronary syndrome by a single, pre-hospital troponin measurement: a randomized trial – European Heart Journal

Editorial: To be or not to be admitted to the emergency department for chest pain? A costly dilemma – European Heart Journal

Commentaries:

JC: Can we rule out ACS by a single prehospital troponin measurement? – St. Emyln’s

Rule-Out of NSTE-ACS by a Prehospital Troponin Measurement – American College of Cardiology

RCT | Preliminary study suggests early methylene blue administration reduces vasopressor duration in septic shock patients

16 Mar, 2023 | 13:25h | UTC

Summary: The study aimed to evaluate the efficacy and safety of early adjunctive methylene blue (MB) administration in patients with septic shock. In this single-center randomized controlled trial, 91 patients were randomly assigned to receive MB or placebo, with the primary outcome being the time to vasopressor discontinuation at 28 days.

The study found that the MB group had a significantly shorter time to vasopressor discontinuation, one more day of vasopressor-free days at day 28, a shorter length of stay in the ICU and hospital, and no serious adverse effects related to MB administration.

However, the study was limited by its small sample size and single-center design. Therefore, larger multicenter randomized clinical trials are needed to confirm the potential benefit of MB as an early adjunctive therapy in patients with septic shock.

Article: Early adjunctive methylene blue in patients with septic shock: a randomized controlled trial – Critical Care

Commentary from the author on Twitter

Our review on abdominal tuberculosis, where we summarise all the evidence on gastrointestinal tuberculosis and peritoneal tuberculosis, has been published in @ijg_journal
Great effort by @JhaDayakrishna and @menon_mythili https://t.co/spPXILGNw2 pic.twitter.com/SxnGs0n9DE

— Vishal Sharma (@drvishal82) March 11, 2023

Safety, Efficacy, and Tolerability of Modified Atkins Diet in Persons With Drug-Resistant Epilepsy: A Randomized Controlled Trial – Neurology (link to abstract – $ for full-text)

Efficacy of Ketogenic Diet, Modified Atkins Diet, and Low Glycemic Index Therapy Diet Among Children With Drug-Resistant Epilepsy: A Randomized Clinical Trial – JAMA Pediatrics

News Release: Researchers Identify blood panel to predict placenta accreta – Brigham and Women’s Hospital

RCT | Overall survival with Daratumumab, Lenalidomide, and Dexamethasone in previously treated multiple myeloma

16 Mar, 2023 | 13:07h | UTC

Overall Survival With Daratumumab, Lenalidomide, and Dexamethasone in Previously Treated Multiple Myeloma (POLLUX): A Randomized, Open-Label, Phase III Trial – Journal of Clinical Oncology

Original Study: Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma – New England Journal of Medicine

M-A | Endoscopic surgery for spontaneous supratentorial intracerebral hemorrhage

16 Mar, 2023 | 13:04h | UTC

Endoscopic surgery for spontaneous supratentorial intracerebral haemorrhage: A systematic review and meta-analysis – Frontiers in Neurology

RCT | Insulin degludec is noninferior to insulin detemir for the treatment of pregnant women with type 1 diabetes

16 Mar, 2023 | 12:59h | UTC

Insulin degludec versus insulin detemir, both in combination with insulin aspart, in the treatment of pregnant women with type 1 diabetes (EXPECT): an open‑label, multinational, randomised, controlled, non-inferiority trial – The Lancet Diabetes & Endocrinology (link to abstract – $ for full-text)

News Release: Pregnant people with schizophrenia have threefold risk of interpersonal violence – Canadian Medical Association Journal

FDA issues new information on cases of squamous cell carcinoma and lymphomas around breast implants

RCT | Pre-hospital rule-out of NSTE-ACS by ambulance paramedics with point-of-care troponin is feasible and cost-saving

RCT | Preliminary study suggests early methylene blue administration reduces vasopressor duration in septic shock patients

International consensus statement on allergy and rhinology: allergic rhinitis

Consensus Paper | Small intestinal bacterial overgrowth in gastrointestinal disorders

AACC Guidance document on cervical cancer detection: screening, surveillance, and diagnosis

Review | Evidence-based approach to diagnosis and management of abdominal tuberculosis

Guidelines on male adult testosterone deficiency, with statements for practice

M-A | Maternal and infant outcomes of pregnancy associated with anti-SSA/RO antibodies

Advantages and challenges of using telehealth for home-based palliative care | Systematic mixed studies review

RCT | Impact of two ketogenic diet types in refractory childhood epilepsy

M-A | Low-intensity follow-up after cancer surgery does not reduce patient satisfaction or well-being

Review | Improving vasopressor use in cardiac arrest

Study identifies outpatient procedures associated with increased risk of myocardial infarction

M-A | Active fluid de-resuscitation in critically ill patients with septic shock

Circulating microparticle proteins predict pregnancies complicated by placenta accreta spectrum

RCT | Overall survival with Daratumumab, Lenalidomide, and Dexamethasone in previously treated multiple myeloma

M-A | Endoscopic surgery for spontaneous supratentorial intracerebral hemorrhage

RCT | Insulin degludec is noninferior to insulin detemir for the treatment of pregnant women with type 1 diabetes

Global validation of the AO Spine Upper Cervical Injury Classification

RCT | Intra-articular 10 mg triamcinolone acetonide non-inferior to 40 mg for knee osteoarthritis pain relief

Primary myelofibrosis | 2023 update on diagnosis, risk-stratification, and management

Cohort Study | Risk of interpersonal violence during and after pregnancy among people with schizophrenia

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