HHS Announces First 10 Drugs Up for Price Negotiation

The US Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services, recently selected the 10 drugs for which they will begin negotiating prices as part of the Inflation Reduction Act. The medications are Eliquis; Enbrel; Entresto; Farxiga; Fiasp, Fiasp FlexTouch, Fiasp PenFill, NovoLog, NovoLog FlexPen, NovoLog PenFill; Imbruvica; Januvia; Jardiance; Stelara; and Xarelto.

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Ottobre 2023

Association between engagement in cultural activities and use of general practitioner consultations: 7-year follow-up of adults from the HUNT study, Norway.

Objective
Assess whether engagement in a range of cultural activities, both ‘passive’ and ‘active’ (ie, receptive and creative) participation, is associated with later demand for general practitioner (GP) consultations.

Design
Longitudinal prospective cohort study.

Setting
Data from the population-based the third Survey of Trøndelag Health Study (2006–2008) in Norway was linked to an administrative register including service information from all GP offices nationwide.

Participants
This study included 17 396 (54.6%) women and 14 451 (45.4%) men aged 30–79 years.

Main outcome measures
Multilevel negative binomial regression models assessed the relationship between cultural engagement and GP consultations, and reported as rate ratios.

Results
A mean of 3.57 GP visits per patient was recorded during the 7 years of follow-up. Participation in creative activities and a combination of both receptive and creative activities was associated with lower number of GP consultation. Gender-specific analyses suggest that these effects were attributable to men. The rate ratio of GP consultations among men taking part in creative activities less than once, twice and more than twice (

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Settembre 2023

Longitudinal cohort study investigating neurodevelopmental and socioemotional outcomes in school-entry aged children after open heart surgery in Australia and New Zealand: the NITRIC follow-up study protocol

Introduction
Despite growing awareness of neurodevelopmental impairments in children with congenital heart disease (CHD), there is a lack of large, longitudinal, population-based cohorts. Little is known about the contemporary neurodevelopmental profile and the emergence of specific impairments in children with CHD entering school. The performance of standardised screening tools to predict neurodevelopmental outcomes at school age in this high-risk population remains poorly understood. The NITric oxide during cardiopulmonary bypass to improve Recovery in Infants with Congenital heart defects (NITRIC) trial randomised 1371 children

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Agosto 2023

Fractional Flow Reserve–Guided PCI or Coronary Bypass Surgery for 3-Vessel Coronary Artery Disease: 3-Year Follow-Up of the FAME 3 Trial

Circulation, Ahead of Print. BACKGROUND:Previous studies comparing percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG) in patients with multivessel coronary disease not involving the left main have shown significantly lower rates of death, myocardial infarction (MI), or stroke after CABG. These studies did not routinely use current-generation drug-eluting stents or fractional flow reserve (FFR) to guide PCI.METHODS:FAME 3 (Fractional Flow Reserve versus Angiography for Multivessel Evaluation) is an investigator-initiated, multicenter, international, randomized trial involving patients with 3-vessel coronary artery disease (not involving the left main coronary artery) in 48 centers worldwide. Patients were randomly assigned to receive FFR-guided PCI using zotarolimus drug-eluting stents or CABG. The prespecified key secondary end point of the trial reported here is the 3-year incidence of the composite of death, MI, or stroke.RESULTS:A total of 1500 patients were randomized to FFR-guided PCI or CABG. Follow-up was achieved in >96% of patients in both groups. There was no difference in the incidence of the composite of death, MI, or stroke after FFR-guided PCI compared with CABG (12.0% versus 9.2%; hazard ratio [HR], 1.3 [95% CI, 0.98–1.83];P=0.07). The rates of death (4.1% versus 3.9%; HR, 1.0 [95% CI, 0.6–1.7];P=0.88) and stroke (1.6% versus 2.0%; HR, 0.8 [95% CI, 0.4–1.7];P=0.56) were not different. MI occurred more frequently after PCI (7.0% versus 4.2%; HR, 1.7 [95% CI, 1.1–2.7];P=0.02).CONCLUSIONS:At 3-year follow-up, there was no difference in the incidence of the composite of death, MI, or stroke after FFR-guided PCI with current-generation drug-eluting stents compared with CABG. There was a higher incidence of MI after PCI compared with CABG, with no difference in death or stroke. These results provide contemporary data to allow improved shared decision-making between physicians and patients with 3-vessel coronary artery disease.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT02100722.

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Agosto 2023

Misdiagnosis Might Harm up to 800 000 US Patients Annually

About 795 000 people die or are permanently disabled each year due to diagnostic errors and related harms across clinical settings, according to estimates based on nationally representative disease incidence data for 2012 to 2014. Conservative methods suggest the number might be lower, at approximately 549 000 people harmed, according to the analysis.

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Agosto 2023

Management of acute non-specific low back pain in the emergency department: do emergency physicians follow the guidelines? Results of a cross-sectional survey

Objectives
Clinical guidelines for acute non-specific low back pain (LBP) recommend avoiding imaging studies or invasive treatments and to advise patients to stay active. The aim of this study was to evaluate the management of acute non-specific LBP in the emergency departments (ED).

Setting
We invited all department chiefs of Swiss EDs and their physician staff to participate in a web-based survey using two clinical case vignettes of patients with acute non-specific LBP presenting to an ED. In both cases, no neurological deficits or red flags were present. Guideline adherence and low-value care was defined based on current guideline recommendations.

Results
In total, 263 ED physicians completed at least one vignette, while 212 completed both vignettes (43% residents, 32% senior/attending physicians and 24% chief physicians). MRI was considered in 31% in vignette 1 and 65% in vignette 2. For pain management, non-steroidal anti-inflammatory drugs, paracetamol and metamizole were mostly used. A substantial proportion of ED physicians considered treatments with questionable benefit and/or increased risk for adverse events such as oral steroids (vignette 1, 12% and vignette 2, 19%), muscle relaxants (33% and 38%), long-acting strong opioids (25% and 33%) and spinal injections (22% and 43%). Although guidelines recommend staying active, 72% and 67% of ED physicians recommended activity restrictions.

Conclusion
Management of acute non-specific LBP in the ED was not in agreement with current guideline recommendations in a substantial proportion of ED physicians. Overuse of imaging studies, the use of long-acting opioids and muscle relaxants, as well as recommendations for activity and work restrictions were prevalent and may potentially be harmful.

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Agosto 2023