Effect of Early High-Flow Nasal Oxygen vs Standard Oxygen Therapy on Length of Hospital Stay in Hospitalized Children With Acute Hypoxemic Respiratory Failure

Liao

2023

JAMA

devices via unique device identifiers (UDIs), as called for by Rathi and others. 2,3 Using UDIs to identify devices would allow researchers to explicitly describe different device models in circulation, the number of devices in circulation, and which devices were included in recalls. Unfortunately, UDIs are not readily available in most health care data sets.In short, we believe that being novelty agnostic and using medical device clearances as the unit of observation is the best and most neutral analytic strategy given the available data. At the same time, we underscore the potential of UDIs to support future regulatory science research and, more broadly, public health.Regarding Dr Robles' comments, we agree regarding the limitations associated with identifying 510(k) predicate devices via algorithms. It is especially difficult to identify predicate devices for older 510(k) medical devices, but predicate information for newer devices is also inconsistently available. Both Robles' article 4 and our study 1 illustrated the need for greater data availability and transparency from regulators and manufacturers.However, we disagree with the characterization that Robles "introduced" the process of identifying 510(k) predicate devices with algorithms. Our team published a 2020 peerreviewed conference proceeding 5 that provided a step-bystep description of our text extraction algorithm and its limitations. Our publication 5 preceded the Robles article 4 and offered more detail about how to implement the algorithm.Regardless of publication chronology, our study's introduction 1 was intended to summarize studies examining the relationship between cited predicate devices and medical device safety (our research question), rather than describe approaches to documenting predicate histories. Given that the article by Robles 4 did not examine the relationship between predicate features and device safety, we consider it appropriate not to have included this reference.

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confidence: 70%

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confidence: 93%

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confidence: 99%

See 1 more Smart Citation

High-Flow Nasal Oxygen vs Standard Oxygen Therapy and Length of Hospital Stay in Children With Acute Hypoxemic Respiratory Failure

Liao

2023

JAMA

“…A greater proportion of children in the high flow oxygen group were admitted to the ICU (12.5% vs 6.9%) and did not tolerate the assigned treatment compared with children in the standard oxygen group. 21 The reasons of the observed increase in bronchiolitis ICU admission rates across the globe remain unclear, standing the stable hospital length of stay over most studies. The greater availability and use of NIV including HFNC without high quality evidence to guide its implementation, and the difficulty of the hospital team supervising HFNC in the ward may have at least contributed to this increase.…”

Section: F O R P U B L I C a T I O Nmentioning

confidence: 99%

The naked emperor: that is the realm of logical fallacy

Benedictis¹,

Boner²,

Bush³

2023

Pediatr Respir J

Bronchiolitis is the most common cause of admission to hospital for infants in high-income countries.Management recommendations, based predominantly on high-quality evidence, state that the mainstays of treatment remain supportive interventions, such as oxygen therapy and hydration only.Despite evidence of no efficacy for salbutamol, adrenaline, glucocorticoids, antibiotics or chest X-ray, and repeated warnings to improve practice being published, substantial variation in practice continues. Evidence suggests use of high-flow oxygen therapy in bronchiolitis does not decrease length of hospitalization and rates of intensive care unit admission or intubation. High-flow oxygen should be limited to rescue therapy after failure of conventional nasal oxygen only in infants who are hypoxic.Reducing the use of inappropriate health interventions is important for minimizing patient harm, maximizing resources, and improving evidence-based health care delivery. Despite international clinical guidelines promoting supportive rather than interventional therapy, universal de-M a n u s c r i p t a c c e p t e d f o r p u b l i c a t i o n implementation of interventional care in bronchiolitis has not occurred and remains a major challenge.

“…In the Original Investigation titled “Effect of Early High-Flow Nasal Oxygen vs Standard Oxygen Therapy on Length of Hospital Stay in Hospitalized Children With Acute Hypoxemic Respiratory Failure: The PARIS-2 Randomized Clinical Trial,” published in the January 17, 2023, issue of JAMA , there was a percentage error. In Table 1, under the heading “Viral testing and data collected at randomization,” and under the category “Clinical diagnosis group,” in the last row under this category, “Other diagnosis group,” the data for the third column (“Standard oxygen”), should have been “15 (1.96)” instead of “15 (19.6).” This article was corrected online.…”

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confidence: 99%

Percentage Error in Table

2023

JAMA

In Reply The Letter from Drs Berenbrok and Mormer describes a care delivery model, versions of which are currently being promoted at the University of Pittsburgh, 1,2 the University of Maryland, 3 and elsewhere nationally, that involves educating and empowering pharmacists to serve as a front-line interface with consumers seeking hearing aids, and as a conduit for appropriate referrals to audiologists and otologists when needed.We agree with Berenbrok and Mormer that this represents a promising approach. As we noted in our Viewpoint, 4 many people could potentially benefit from hearing aid technology. While continued efforts aimed at developing and advancing therapeutic technologies are essential, it is also urgent to improve delivery of these therapeutics to ensure that all persons, including those who are part of marginalized communities or who experience geographic challenges in accessing care, are able to benefit from them and receive the best care possible. Furthermore, these improvements will require the combined efforts of the clinical, research, and technology development communities, and additional investigations will be needed to determine the best service delivery models for maximizing benefit for consumers. 4 With regard to collaboration between pharmacists, audiologists, and otologists, we particularly welcome health services and implementation science research to better understand the optimal health care team configuration to deliver the best care across various populations, and to ensure that expert guidance is readily accessible by patients and consumers when needed.