NEW YORK – When data were combined from two parallel phase 3 bronchiectasis treatment trials, inhaled colistimethate sodium failed to significantly reduce the rate of exacerbations associated with Pseudomonas aeruginosa infection, but the disparity in the findings from the two trials, presented at the 6th World Bronchiectasis & NTM Conference (WBC) 2023, strongly suggests that this therapy is effective after all.

“The totality of the evidence supports a consistent and clinically meaningful benefit [of this therapy] outside of pandemic conditions,” reported Charles Haworth, MD, director, Cambridge Centre for Lung Infection, Royal Papworth Hospital, Cambridge, England.

The key phrase is “outside of pandemic conditions.” PROMIS I, which was fully enrolled before the COVID-19 pandemic descended, associated the inhaled therapy with highly significant benefits. PROMIS II, which was initiated later and enrolled 40% of its participants during the pandemic, did not.

The difference between these two trials, which were essentially identical, was the timing, according to Dr. Haworth. By starting later, PROMIS II caught the onset of the pandemic, which he believes introduced numerous problems that defeated the opportunity to show an advantage for the inhaled antibiotic.

Injectable colistimethate sodium, a decades-old formulation of colistin, is already approved in the United States for gram-negative infections and is considered helpful even in challenging diseases, such as cystic fibrosis. Positive results from a phase 2 trial with inhaled colistimethate sodium in bronchiectasis patients with P. aeruginosa infection provided the rationale for the phase 3 PROMIS program.

The key entry criterion of PROMIS I and PROMIS II, each with nearly 90 participating study sites, was a history of bronchiectasis and ≥ two P. aeruginosa infections requiring oral therapy or ≥ 1 infection requiring intravenous therapy in the prior 12 months. Patients were randomly assigned to receive colistimethate sodium delivered in the proprietary I-neb nebulizer (CMS I-neb) or a matching placebo.

On the primary endpoint of annualized rate of exacerbations, the figures per year were 0.58 for CMS I-neb and 0.95 for placebo in the PROMIS I trial. This produced a rate ratio of 0.65, signaling a significant 35% (P = .00101) reduction in risk. In PROMIS II, the annualized rates of exacerbation were essentially identical in the experimental and control arms (0.089 vs. 0.088; P = .97).

With “no signal of benefit” in the PROMIS II trial, the numerical advantage of CMS I-neb for the combined data did not reach statistical significance, Dr. Haworth reported.

Other endpoints told the same story. For example, the time to first exacerbation was reduced by 41% in PROMIS I (HR, 0.59; P = .0074) but was not reduced significantly (P = .603) in PROMIS II. In PROMIS I, there was a nearly 60% reduction in the risk of severe exacerbations associated with CMS I-neb, but the risk ratio of severe infections was slightly but not significantly higher on CMS I-neb in PROMIS II.

There were signals of benefit in PROMIS II. For example, the reductions in P. aeruginosa density were similar in the two studies (P < .00001 in both), and assessment with the Severe Exacerbations and Quality of Life (SQOL) tool associated CMS I-neb with end-of-study improvement in QOL for the experimental arm in both studies.

While Dr. Haworth acknowledged that he recognizes the “issues of post hoc analysis with any data,” he argued that there is compelling evidence that the pandemic “severely disrupted the conduct of the trial,” obscuring a benefit that would have been otherwise shown.

Besides the dramatic reduction in rates of hospitalization during the pandemic, an obstacle for showing differences in exacerbations, and other COVID-related factors with the potential to skew results, Dr. Haworth also provided several sets of objective data to make his point.

Most importantly, Dr. Haworth and his coinvestigators conducted a meta-analysis that combined data from the phase 2 trial, data from PROMIS I, and data from the patients enrolled in PROMIS II prior to the COVID pandemic. In this analysis the rate ratio for annualized exacerbations was a “pretty impressive” 0.65 favoring CMS I-neb. Moreover, in contrast to data from the PROMIS II patients enrolled during the COVID pandemic, the other three sets of data were “remarkably consistent.”

If PROMIS II data collected from patients enrolled during COVID are compared with the other sets of data, they are “the clear outlier,” he asserted.

Many guidelines in Europe, including those from the European Respiratory Society and the British Thoracic Society, already recommend inhaled colistin in patients with bronchiectasis for the treatment of P. aeruginosa. Although Dr. Haworth believes that the preponderance of controlled data now argue that CMS I-neb is effective as well as safe (adverse events in the experimental and placebo arms of PROMIS I and II were similar), he is not sure what steps will be taken to confirm a benefit to regulatory authorities. According to Dr. Haworth, there are no approved inhaled antibiotics in the United States.

Referring to Zambon, which funded the trials and is developing CMS I-neb, Dr. Haworth said, “This will be a company decision. There are some logistical hurdles to doing another trial.”

Not least of these hurdles is that clinicians and patients already consider inhalational antibiotics in general and inhaled colistin specifically to be effective for several types of infections, including P. aeruginosa, according to Eva Polverino, MD, PhD, a pulmonologist associated with the Hospital Clinic of Barcelona. She said that these drugs are already a standard of care in her own country as well as in many other countries in Europe.

“There has been a loss of equipoise needed to conduct a randomized placebo-controlled trial,” Dr. Polverino said. In her opinion, the U.S. FDA “should start thinking of other pathways to approval.” She thinks that enrollment in a placebo-controlled trial is no longer appropriate.

Dr. Haworth and Dr. Polverino have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

NEW YORK – When data were combined from two parallel phase 3 bronchiectasis treatment trials, inhaled colistimethate sodium failed to significantly reduce the rate of exacerbations associated with Pseudomonas aeruginosa infection, but the disparity in the findings from the two trials, presented at the 6th World Bronchiectasis & NTM Conference (WBC) 2023, strongly suggests that this therapy is effective after all.

“The totality of the evidence supports a consistent and clinically meaningful benefit [of this therapy] outside of pandemic conditions,” reported Charles Haworth, MD, director, Cambridge Centre for Lung Infection, Royal Papworth Hospital, Cambridge, England.

The key phrase is “outside of pandemic conditions.” PROMIS I, which was fully enrolled before the COVID-19 pandemic descended, associated the inhaled therapy with highly significant benefits. PROMIS II, which was initiated later and enrolled 40% of its participants during the pandemic, did not.

The difference between these two trials, which were essentially identical, was the timing, according to Dr. Haworth. By starting later, PROMIS II caught the onset of the pandemic, which he believes introduced numerous problems that defeated the opportunity to show an advantage for the inhaled antibiotic.

Injectable colistimethate sodium, a decades-old formulation of colistin, is already approved in the United States for gram-negative infections and is considered helpful even in challenging diseases, such as cystic fibrosis. Positive results from a phase 2 trial with inhaled colistimethate sodium in bronchiectasis patients with P. aeruginosa infection provided the rationale for the phase 3 PROMIS program.

The key entry criterion of PROMIS I and PROMIS II, each with nearly 90 participating study sites, was a history of bronchiectasis and ≥ two P. aeruginosa infections requiring oral therapy or ≥ 1 infection requiring intravenous therapy in the prior 12 months. Patients were randomly assigned to receive colistimethate sodium delivered in the proprietary I-neb nebulizer (CMS I-neb) or a matching placebo.

On the primary endpoint of annualized rate of exacerbations, the figures per year were 0.58 for CMS I-neb and 0.95 for placebo in the PROMIS I trial. This produced a rate ratio of 0.65, signaling a significant 35% (P = .00101) reduction in risk. In PROMIS II, the annualized rates of exacerbation were essentially identical in the experimental and control arms (0.089 vs. 0.088; P = .97).

With “no signal of benefit” in the PROMIS II trial, the numerical advantage of CMS I-neb for the combined data did not reach statistical significance, Dr. Haworth reported.

Other endpoints told the same story. For example, the time to first exacerbation was reduced by 41% in PROMIS I (HR, 0.59; P = .0074) but was not reduced significantly (P = .603) in PROMIS II. In PROMIS I, there was a nearly 60% reduction in the risk of severe exacerbations associated with CMS I-neb, but the risk ratio of severe infections was slightly but not significantly higher on CMS I-neb in PROMIS II.

There were signals of benefit in PROMIS II. For example, the reductions in P. aeruginosa density were similar in the two studies (P < .00001 in both), and assessment with the Severe Exacerbations and Quality of Life (SQOL) tool associated CMS I-neb with end-of-study improvement in QOL for the experimental arm in both studies.

While Dr. Haworth acknowledged that he recognizes the “issues of post hoc analysis with any data,” he argued that there is compelling evidence that the pandemic “severely disrupted the conduct of the trial,” obscuring a benefit that would have been otherwise shown.

Besides the dramatic reduction in rates of hospitalization during the pandemic, an obstacle for showing differences in exacerbations, and other COVID-related factors with the potential to skew results, Dr. Haworth also provided several sets of objective data to make his point.

Most importantly, Dr. Haworth and his coinvestigators conducted a meta-analysis that combined data from the phase 2 trial, data from PROMIS I, and data from the patients enrolled in PROMIS II prior to the COVID pandemic. In this analysis the rate ratio for annualized exacerbations was a “pretty impressive” 0.65 favoring CMS I-neb. Moreover, in contrast to data from the PROMIS II patients enrolled during the COVID pandemic, the other three sets of data were “remarkably consistent.”

If PROMIS II data collected from patients enrolled during COVID are compared with the other sets of data, they are “the clear outlier,” he asserted.

Many guidelines in Europe, including those from the European Respiratory Society and the British Thoracic Society, already recommend inhaled colistin in patients with bronchiectasis for the treatment of P. aeruginosa. Although Dr. Haworth believes that the preponderance of controlled data now argue that CMS I-neb is effective as well as safe (adverse events in the experimental and placebo arms of PROMIS I and II were similar), he is not sure what steps will be taken to confirm a benefit to regulatory authorities. According to Dr. Haworth, there are no approved inhaled antibiotics in the United States.

Referring to Zambon, which funded the trials and is developing CMS I-neb, Dr. Haworth said, “This will be a company decision. There are some logistical hurdles to doing another trial.”

Not least of these hurdles is that clinicians and patients already consider inhalational antibiotics in general and inhaled colistin specifically to be effective for several types of infections, including P. aeruginosa, according to Eva Polverino, MD, PhD, a pulmonologist associated with the Hospital Clinic of Barcelona. She said that these drugs are already a standard of care in her own country as well as in many other countries in Europe.

“There has been a loss of equipoise needed to conduct a randomized placebo-controlled trial,” Dr. Polverino said. In her opinion, the U.S. FDA “should start thinking of other pathways to approval.” She thinks that enrollment in a placebo-controlled trial is no longer appropriate.

Dr. Haworth and Dr. Polverino have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

NEW YORK – When data were combined from two parallel phase 3 bronchiectasis treatment trials, inhaled colistimethate sodium failed to significantly reduce the rate of exacerbations associated with Pseudomonas aeruginosa infection, but the disparity in the findings from the two trials, presented at the 6th World Bronchiectasis & NTM Conference (WBC) 2023, strongly suggests that this therapy is effective after all.

“The totality of the evidence supports a consistent and clinically meaningful benefit [of this therapy] outside of pandemic conditions,” reported Charles Haworth, MD, director, Cambridge Centre for Lung Infection, Royal Papworth Hospital, Cambridge, England.

The key phrase is “outside of pandemic conditions.” PROMIS I, which was fully enrolled before the COVID-19 pandemic descended, associated the inhaled therapy with highly significant benefits. PROMIS II, which was initiated later and enrolled 40% of its participants during the pandemic, did not.

The difference between these two trials, which were essentially identical, was the timing, according to Dr. Haworth. By starting later, PROMIS II caught the onset of the pandemic, which he believes introduced numerous problems that defeated the opportunity to show an advantage for the inhaled antibiotic.

Injectable colistimethate sodium, a decades-old formulation of colistin, is already approved in the United States for gram-negative infections and is considered helpful even in challenging diseases, such as cystic fibrosis. Positive results from a phase 2 trial with inhaled colistimethate sodium in bronchiectasis patients with P. aeruginosa infection provided the rationale for the phase 3 PROMIS program.

The key entry criterion of PROMIS I and PROMIS II, each with nearly 90 participating study sites, was a history of bronchiectasis and ≥ two P. aeruginosa infections requiring oral therapy or ≥ 1 infection requiring intravenous therapy in the prior 12 months. Patients were randomly assigned to receive colistimethate sodium delivered in the proprietary I-neb nebulizer (CMS I-neb) or a matching placebo.

On the primary endpoint of annualized rate of exacerbations, the figures per year were 0.58 for CMS I-neb and 0.95 for placebo in the PROMIS I trial. This produced a rate ratio of 0.65, signaling a significant 35% (P = .00101) reduction in risk. In PROMIS II, the annualized rates of exacerbation were essentially identical in the experimental and control arms (0.089 vs. 0.088; P = .97).

With “no signal of benefit” in the PROMIS II trial, the numerical advantage of CMS I-neb for the combined data did not reach statistical significance, Dr. Haworth reported.

Other endpoints told the same story. For example, the time to first exacerbation was reduced by 41% in PROMIS I (HR, 0.59; P = .0074) but was not reduced significantly (P = .603) in PROMIS II. In PROMIS I, there was a nearly 60% reduction in the risk of severe exacerbations associated with CMS I-neb, but the risk ratio of severe infections was slightly but not significantly higher on CMS I-neb in PROMIS II.

There were signals of benefit in PROMIS II. For example, the reductions in P. aeruginosa density were similar in the two studies (P < .00001 in both), and assessment with the Severe Exacerbations and Quality of Life (SQOL) tool associated CMS I-neb with end-of-study improvement in QOL for the experimental arm in both studies.

While Dr. Haworth acknowledged that he recognizes the “issues of post hoc analysis with any data,” he argued that there is compelling evidence that the pandemic “severely disrupted the conduct of the trial,” obscuring a benefit that would have been otherwise shown.

Besides the dramatic reduction in rates of hospitalization during the pandemic, an obstacle for showing differences in exacerbations, and other COVID-related factors with the potential to skew results, Dr. Haworth also provided several sets of objective data to make his point.

Most importantly, Dr. Haworth and his coinvestigators conducted a meta-analysis that combined data from the phase 2 trial, data from PROMIS I, and data from the patients enrolled in PROMIS II prior to the COVID pandemic. In this analysis the rate ratio for annualized exacerbations was a “pretty impressive” 0.65 favoring CMS I-neb. Moreover, in contrast to data from the PROMIS II patients enrolled during the COVID pandemic, the other three sets of data were “remarkably consistent.”

If PROMIS II data collected from patients enrolled during COVID are compared with the other sets of data, they are “the clear outlier,” he asserted.

Many guidelines in Europe, including those from the European Respiratory Society and the British Thoracic Society, already recommend inhaled colistin in patients with bronchiectasis for the treatment of P. aeruginosa. Although Dr. Haworth believes that the preponderance of controlled data now argue that CMS I-neb is effective as well as safe (adverse events in the experimental and placebo arms of PROMIS I and II were similar), he is not sure what steps will be taken to confirm a benefit to regulatory authorities. According to Dr. Haworth, there are no approved inhaled antibiotics in the United States.

Referring to Zambon, which funded the trials and is developing CMS I-neb, Dr. Haworth said, “This will be a company decision. There are some logistical hurdles to doing another trial.”

Not least of these hurdles is that clinicians and patients already consider inhalational antibiotics in general and inhaled colistin specifically to be effective for several types of infections, including P. aeruginosa, according to Eva Polverino, MD, PhD, a pulmonologist associated with the Hospital Clinic of Barcelona. She said that these drugs are already a standard of care in her own country as well as in many other countries in Europe.

“There has been a loss of equipoise needed to conduct a randomized placebo-controlled trial,” Dr. Polverino said. In her opinion, the U.S. FDA “should start thinking of other pathways to approval.” She thinks that enrollment in a placebo-controlled trial is no longer appropriate.

Dr. Haworth and Dr. Polverino have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Lower doses of initial vasopressin were associated with lower mortality when used as an adjunct in patients with septic shock, according to a review of three recent studies.

“Patients with septic shock require vasoactive agents to restore adequate tissue perfusion,” writes Gretchen L. Sacha, PharmD, of the Cleveland Clinic and colleagues.

Vasopressin is an attractive alternative to norepinephrine because it avoids the adverse effects associated with catecholamines, the researchers say. Although vasopressin is the recommended second-line adjunct after norepinephrine for patients with septic shock, findings to guide its use are inconsistent and data on the timing are limited, they note.

In a review published in the journal CHEST, the researchers summarize the three large, randomized trials to date examining the use of norepinephrine and vasopressin in patients with septic shock.

In the Vasopressin in Septic Shock Trial (VASST), 382 patients with septic shock were randomized to open-label norepinephrine with blinded norepinephrine, and 382 were randomized to open-label norepinephrine with blinded adjunctive vasopressin.

After initiation of the study drug, patients randomized to vasopressin had significantly lower requirements for open-label norepinephrine (P < .001). Although no differences occurred in the primary outcome of 28-day mortality, 90-day mortality was lower in the vasopressin group.

In the Vasopressin vs Norepinephrine as Initial Therapy in Septic Shock (VANISH) trial, 204 patients with septic shock were randomized to norepinephrine and 204 to vasopressin as an initial vasoactive agent. Although no differences appeared between the groups for the two primary outcomes of 28-day mortality and days free of kidney failure, the vasopressin group had a lower frequency of the use of kidney replacement therapy (absolute difference –9.9% vs. –0.6%).

The VANISH study was limited by the fact that 85% of the patients were receiving norepinephrine when they were randomized; “therefore, this study is best described as evaluating catecholamine-adjunctive vasopressin,” the researchers say.

The third clinical trial, published only as an abstract, randomized 387 patients with septic shock who were already receiving low doses of norepinephrine to either norepinephrine with adjunctive vasopressin or norepinephrine alone. Rates of 28-day mortality were significantly lower in the vasopressin group (34.0% vs. 42.3%; P = .03).

Several meta-analyses involving multiple vasopressin receptor agonists have shown an association between reduced mortality and their use. In addition, recent observational studies have shown an association between lower mortality and the initiation of vasopressors at a lower norepinephrine-equivalent dose or lower lactate concentration.

As for clinical implications, the 2021 version of the Surviving Sepsis Campaign (SSC) guidelines included a meta-analysis of 10 randomized, controlled trials that showed improved mortality associated with vasopressin use. This version of the guidelines was the first to address the timing of vasopressin initiation.

Because of insufficient evidence, the guidance was worded as “in our practice, vasopressin is usually started when the dose of norepinephrine is in the range of 0.25-0.5 mcg/kg/min,” the researchers write. “Although this is not a recommendation by the SSC for a specific threshold of catecholamine dose where vasopressin should be initiated, this statement represents clinician interest and the need for further research on the topic,” they note.

“Future studies of vasopressin should focus on the timing of its initiation at various clinical thresholds and patient selection for receipt of vasopressin,” they conclude.

The study was supported by the National Institutes of Health, National Institute of General Medical Sciences. Dr. Sacha has disclosed consulting for Wolters Kluwer.

A version of this article first appeared on Medscape.com.

Lower doses of initial vasopressin were associated with lower mortality when used as an adjunct in patients with septic shock, according to a review of three recent studies.

“Patients with septic shock require vasoactive agents to restore adequate tissue perfusion,” writes Gretchen L. Sacha, PharmD, of the Cleveland Clinic and colleagues.

Vasopressin is an attractive alternative to norepinephrine because it avoids the adverse effects associated with catecholamines, the researchers say. Although vasopressin is the recommended second-line adjunct after norepinephrine for patients with septic shock, findings to guide its use are inconsistent and data on the timing are limited, they note.

In a review published in the journal CHEST, the researchers summarize the three large, randomized trials to date examining the use of norepinephrine and vasopressin in patients with septic shock.

In the Vasopressin in Septic Shock Trial (VASST), 382 patients with septic shock were randomized to open-label norepinephrine with blinded norepinephrine, and 382 were randomized to open-label norepinephrine with blinded adjunctive vasopressin.

After initiation of the study drug, patients randomized to vasopressin had significantly lower requirements for open-label norepinephrine (P < .001). Although no differences occurred in the primary outcome of 28-day mortality, 90-day mortality was lower in the vasopressin group.

In the Vasopressin vs Norepinephrine as Initial Therapy in Septic Shock (VANISH) trial, 204 patients with septic shock were randomized to norepinephrine and 204 to vasopressin as an initial vasoactive agent. Although no differences appeared between the groups for the two primary outcomes of 28-day mortality and days free of kidney failure, the vasopressin group had a lower frequency of the use of kidney replacement therapy (absolute difference –9.9% vs. –0.6%).

The VANISH study was limited by the fact that 85% of the patients were receiving norepinephrine when they were randomized; “therefore, this study is best described as evaluating catecholamine-adjunctive vasopressin,” the researchers say.

The third clinical trial, published only as an abstract, randomized 387 patients with septic shock who were already receiving low doses of norepinephrine to either norepinephrine with adjunctive vasopressin or norepinephrine alone. Rates of 28-day mortality were significantly lower in the vasopressin group (34.0% vs. 42.3%; P = .03).

Several meta-analyses involving multiple vasopressin receptor agonists have shown an association between reduced mortality and their use. In addition, recent observational studies have shown an association between lower mortality and the initiation of vasopressors at a lower norepinephrine-equivalent dose or lower lactate concentration.

As for clinical implications, the 2021 version of the Surviving Sepsis Campaign (SSC) guidelines included a meta-analysis of 10 randomized, controlled trials that showed improved mortality associated with vasopressin use. This version of the guidelines was the first to address the timing of vasopressin initiation.

Because of insufficient evidence, the guidance was worded as “in our practice, vasopressin is usually started when the dose of norepinephrine is in the range of 0.25-0.5 mcg/kg/min,” the researchers write. “Although this is not a recommendation by the SSC for a specific threshold of catecholamine dose where vasopressin should be initiated, this statement represents clinician interest and the need for further research on the topic,” they note.

“Future studies of vasopressin should focus on the timing of its initiation at various clinical thresholds and patient selection for receipt of vasopressin,” they conclude.

The study was supported by the National Institutes of Health, National Institute of General Medical Sciences. Dr. Sacha has disclosed consulting for Wolters Kluwer.

A version of this article first appeared on Medscape.com.

Lower doses of initial vasopressin were associated with lower mortality when used as an adjunct in patients with septic shock, according to a review of three recent studies.

“Patients with septic shock require vasoactive agents to restore adequate tissue perfusion,” writes Gretchen L. Sacha, PharmD, of the Cleveland Clinic and colleagues.

Vasopressin is an attractive alternative to norepinephrine because it avoids the adverse effects associated with catecholamines, the researchers say. Although vasopressin is the recommended second-line adjunct after norepinephrine for patients with septic shock, findings to guide its use are inconsistent and data on the timing are limited, they note.

In a review published in the journal CHEST, the researchers summarize the three large, randomized trials to date examining the use of norepinephrine and vasopressin in patients with septic shock.

In the Vasopressin in Septic Shock Trial (VASST), 382 patients with septic shock were randomized to open-label norepinephrine with blinded norepinephrine, and 382 were randomized to open-label norepinephrine with blinded adjunctive vasopressin.

After initiation of the study drug, patients randomized to vasopressin had significantly lower requirements for open-label norepinephrine (P < .001). Although no differences occurred in the primary outcome of 28-day mortality, 90-day mortality was lower in the vasopressin group.

In the Vasopressin vs Norepinephrine as Initial Therapy in Septic Shock (VANISH) trial, 204 patients with septic shock were randomized to norepinephrine and 204 to vasopressin as an initial vasoactive agent. Although no differences appeared between the groups for the two primary outcomes of 28-day mortality and days free of kidney failure, the vasopressin group had a lower frequency of the use of kidney replacement therapy (absolute difference –9.9% vs. –0.6%).

The VANISH study was limited by the fact that 85% of the patients were receiving norepinephrine when they were randomized; “therefore, this study is best described as evaluating catecholamine-adjunctive vasopressin,” the researchers say.

The third clinical trial, published only as an abstract, randomized 387 patients with septic shock who were already receiving low doses of norepinephrine to either norepinephrine with adjunctive vasopressin or norepinephrine alone. Rates of 28-day mortality were significantly lower in the vasopressin group (34.0% vs. 42.3%; P = .03).

Several meta-analyses involving multiple vasopressin receptor agonists have shown an association between reduced mortality and their use. In addition, recent observational studies have shown an association between lower mortality and the initiation of vasopressors at a lower norepinephrine-equivalent dose or lower lactate concentration.

As for clinical implications, the 2021 version of the Surviving Sepsis Campaign (SSC) guidelines included a meta-analysis of 10 randomized, controlled trials that showed improved mortality associated with vasopressin use. This version of the guidelines was the first to address the timing of vasopressin initiation.

Because of insufficient evidence, the guidance was worded as “in our practice, vasopressin is usually started when the dose of norepinephrine is in the range of 0.25-0.5 mcg/kg/min,” the researchers write. “Although this is not a recommendation by the SSC for a specific threshold of catecholamine dose where vasopressin should be initiated, this statement represents clinician interest and the need for further research on the topic,” they note.

“Future studies of vasopressin should focus on the timing of its initiation at various clinical thresholds and patient selection for receipt of vasopressin,” they conclude.

The study was supported by the National Institutes of Health, National Institute of General Medical Sciences. Dr. Sacha has disclosed consulting for Wolters Kluwer.

A version of this article first appeared on Medscape.com.

Neutropenia and radiological findings affected the presentation and diagnosis of pulmonary mucormycosis in adult patients, based on data from 114 individuals.

Diagnosis of pulmonary mucormycosis (PM), an invasive and potentially life-threatening fungal infection, is often delayed because of its variable presentation, wrote Anne Coste, MD, of La Cavale Blanche Hospital and Brest (France) University Hospital, and colleagues.

Improved diagnostic tools including molecular identification and image-guided lung biopsies are now available in many centers, but relations between underlying conditions, clinical presentations, and diagnostic methods have not been described, they said.

In a study published in the journal Chest, the researchers reviewed data from all cases of PM seen at six hospitals in France between 2008 and 2019. PM cases were based on European Organization for Research and Treatment of Cancer and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) criteria. Diabetes and trauma were included as additional host factors, and positive serum or tissue PCR (serum qPCR) were included as mycological evidence. Participants also underwent thoracic computed tomography (CT) scans.

The most common underlying conditions among the 114 patients were hematological malignancy (49%), allogeneic hematopoietic stem-cell transplantation (21%), and solid organ transplantation (17%).

Among the 40% of the cases that involved dissemination, the most common sites were the liver (48%), spleen (48%), brain (44%), and kidneys (37%).

A review of radiology findings showed consolidation in a majority of patients (58%), as well as pleural effusion (52%). Other findings included reversed halo sign (RHS, 26%), halo sign (24%), vascular abnormalities (26%), and cavity (23%).

Bronchoalveolar lavage (BAL) was present in 46 of 96 patients (50%), and transthoracic lung biopsy was used for diagnosis in 8 of 11 (73%) patients with previous negative BALs.

Seventy patients had neutropenia. Overall, patients with neutropenia were significantly more likely than were those without neutropenia to show an angioinvasive presentation that included both RHS and disease dissemination (P < .05).

In addition, serum qPCR was positive in 42 of 53 patients for whom data were available (79%). Serum qPCR was significantly more likely to be positive in neutropenic patients (91% vs. 62%, P = .02). Positive qPCR was associated with an early diagnosis (P = .03) and treatment onset (P = .01).

Possible reasons for the high rate of disseminated PM in the current study may be the large number of patients with pulmonary involvement, use of body CT data, and availability of autopsy results (for 11% of cases), the researchers wrote in their discussion.

Neutropenia and radiological findings influence disease presentation and contribution of diagnostic tools during PM. Serum qPCR is more contributive in neutropenic patients and BAL examination in nonneutropenic patients. Lung biopsies are highly contributive in case of non-contributive BAL.

The findings were limited by several factors including the retrospective design, the inability to calculate sensitivity and specificity of diagnostic methods, and lack of data on patients with COVID-19, the researchers noted. However, the results provide real-life information for clinicians in centers with current mycological platforms, they concluded.

The study received no outside funding. Dr. Coste had no financial conflicts to disclose.

Neutropenia and radiological findings affected the presentation and diagnosis of pulmonary mucormycosis in adult patients, based on data from 114 individuals.

Diagnosis of pulmonary mucormycosis (PM), an invasive and potentially life-threatening fungal infection, is often delayed because of its variable presentation, wrote Anne Coste, MD, of La Cavale Blanche Hospital and Brest (France) University Hospital, and colleagues.

Improved diagnostic tools including molecular identification and image-guided lung biopsies are now available in many centers, but relations between underlying conditions, clinical presentations, and diagnostic methods have not been described, they said.

In a study published in the journal Chest, the researchers reviewed data from all cases of PM seen at six hospitals in France between 2008 and 2019. PM cases were based on European Organization for Research and Treatment of Cancer and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) criteria. Diabetes and trauma were included as additional host factors, and positive serum or tissue PCR (serum qPCR) were included as mycological evidence. Participants also underwent thoracic computed tomography (CT) scans.

The most common underlying conditions among the 114 patients were hematological malignancy (49%), allogeneic hematopoietic stem-cell transplantation (21%), and solid organ transplantation (17%).

Among the 40% of the cases that involved dissemination, the most common sites were the liver (48%), spleen (48%), brain (44%), and kidneys (37%).

A review of radiology findings showed consolidation in a majority of patients (58%), as well as pleural effusion (52%). Other findings included reversed halo sign (RHS, 26%), halo sign (24%), vascular abnormalities (26%), and cavity (23%).

Bronchoalveolar lavage (BAL) was present in 46 of 96 patients (50%), and transthoracic lung biopsy was used for diagnosis in 8 of 11 (73%) patients with previous negative BALs.

Seventy patients had neutropenia. Overall, patients with neutropenia were significantly more likely than were those without neutropenia to show an angioinvasive presentation that included both RHS and disease dissemination (P < .05).

In addition, serum qPCR was positive in 42 of 53 patients for whom data were available (79%). Serum qPCR was significantly more likely to be positive in neutropenic patients (91% vs. 62%, P = .02). Positive qPCR was associated with an early diagnosis (P = .03) and treatment onset (P = .01).

Possible reasons for the high rate of disseminated PM in the current study may be the large number of patients with pulmonary involvement, use of body CT data, and availability of autopsy results (for 11% of cases), the researchers wrote in their discussion.

Neutropenia and radiological findings influence disease presentation and contribution of diagnostic tools during PM. Serum qPCR is more contributive in neutropenic patients and BAL examination in nonneutropenic patients. Lung biopsies are highly contributive in case of non-contributive BAL.

The findings were limited by several factors including the retrospective design, the inability to calculate sensitivity and specificity of diagnostic methods, and lack of data on patients with COVID-19, the researchers noted. However, the results provide real-life information for clinicians in centers with current mycological platforms, they concluded.

The study received no outside funding. Dr. Coste had no financial conflicts to disclose.

Neutropenia and radiological findings affected the presentation and diagnosis of pulmonary mucormycosis in adult patients, based on data from 114 individuals.

Diagnosis of pulmonary mucormycosis (PM), an invasive and potentially life-threatening fungal infection, is often delayed because of its variable presentation, wrote Anne Coste, MD, of La Cavale Blanche Hospital and Brest (France) University Hospital, and colleagues.

Improved diagnostic tools including molecular identification and image-guided lung biopsies are now available in many centers, but relations between underlying conditions, clinical presentations, and diagnostic methods have not been described, they said.

In a study published in the journal Chest, the researchers reviewed data from all cases of PM seen at six hospitals in France between 2008 and 2019. PM cases were based on European Organization for Research and Treatment of Cancer and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) criteria. Diabetes and trauma were included as additional host factors, and positive serum or tissue PCR (serum qPCR) were included as mycological evidence. Participants also underwent thoracic computed tomography (CT) scans.

The most common underlying conditions among the 114 patients were hematological malignancy (49%), allogeneic hematopoietic stem-cell transplantation (21%), and solid organ transplantation (17%).

Among the 40% of the cases that involved dissemination, the most common sites were the liver (48%), spleen (48%), brain (44%), and kidneys (37%).

A review of radiology findings showed consolidation in a majority of patients (58%), as well as pleural effusion (52%). Other findings included reversed halo sign (RHS, 26%), halo sign (24%), vascular abnormalities (26%), and cavity (23%).

Bronchoalveolar lavage (BAL) was present in 46 of 96 patients (50%), and transthoracic lung biopsy was used for diagnosis in 8 of 11 (73%) patients with previous negative BALs.

Seventy patients had neutropenia. Overall, patients with neutropenia were significantly more likely than were those without neutropenia to show an angioinvasive presentation that included both RHS and disease dissemination (P < .05).

In addition, serum qPCR was positive in 42 of 53 patients for whom data were available (79%). Serum qPCR was significantly more likely to be positive in neutropenic patients (91% vs. 62%, P = .02). Positive qPCR was associated with an early diagnosis (P = .03) and treatment onset (P = .01).

Possible reasons for the high rate of disseminated PM in the current study may be the large number of patients with pulmonary involvement, use of body CT data, and availability of autopsy results (for 11% of cases), the researchers wrote in their discussion.

Neutropenia and radiological findings influence disease presentation and contribution of diagnostic tools during PM. Serum qPCR is more contributive in neutropenic patients and BAL examination in nonneutropenic patients. Lung biopsies are highly contributive in case of non-contributive BAL.

The findings were limited by several factors including the retrospective design, the inability to calculate sensitivity and specificity of diagnostic methods, and lack of data on patients with COVID-19, the researchers noted. However, the results provide real-life information for clinicians in centers with current mycological platforms, they concluded.

The study received no outside funding. Dr. Coste had no financial conflicts to disclose.

It seemed like a typical kind of day. I was out the door by 6:00 a.m., heading into work for a shift on I-35 West, my daily commute. It was still dark out. A little bit colder that morning, but nothing us Texans aren’t used to.

I was cruising down the tollway, which is separated from the main highway by a barrier. That stretch has a slight hill and turns to the left. You can’t see anything beyond the hill when you’re at the bottom.

As I made my way up, I spotted brake lights about 400 yards ahead. I eased on my brake, and next thing I knew, I was sliding.

I realized, I’m on black ice.

I was driving a 2011 Toyota FJ Cruiser and I had it all beefed up – lift tires, winch bumpers front and back. I had never had any sort of issue like that.

My ABS brakes kicked in. I slowed, but not fast enough. I saw a wall of crashed cars in front of me.

I was in the left-hand lane, so I turned my steering wheel into the center median. I could hear the whole side of my vehicle scraping against it. I managed to slow down enough to just tap the vehicle in front of me.

I looked in my passenger side-view mirror and saw headlights coming in the right lane. But this car couldn’t slow down. It crashed into the wreckage to my right.

That’s when it sunk in: There was going to be a car coming in my lane, and it might not be able to stop.

I looked in my rear-view mirror and saw headlights. Sparks flying off that center median.

I didn’t know at the time, but it was a fully loaded semi-truck traveling about 60 miles an hour.

I had a split second to think: This is it. This is how it ends. I closed my eyes.

It was the most violent impact I’ve ever experienced in my life.

I had no idea until afterward, but I had slammed into the vehicle in front of me and my SUV did a kind of 360° barrel roll over the median into the northbound lanes, landing wheels down on top of my sheared off roof rack.

Everything stopped. I opened my eyes. All my airbags had deployed. I gently tried moving my arms and legs, and they worked. I couldn’t move my left foot. It was wedged underneath the brake pedal. But I wasn’t in any pain, just very confused and disoriented. I knew I needed to get out of the vehicle.

My door was wedged shut, so I crawled out of the broken window, slipping on the black ice. I realized I had hit a Fort Worth police cruiser, now all smashed up. The driver couldn’t open his door. So, I helped him force it open, got him out of the vehicle, and checked on him. He was fine.

I had no idea how many vehicles and people were involved. I was in so much shock that the only thing I could do was immediately revert back to my training. I was the only first responder there. No ambulances on scene yet, no fire. So, I did what I know how to do – except without any tools. I tried to triage as many people as I could.

I was helping people with lacerations, back and neck issues from the violent impacts. When you’re involved in a mass casualty incident like that, you have to assess which patients will be the most viable and need the most immediate attention. You have greens, yellows, reds, and then blacks – the deceased. Someone who doesn’t have a pulse and isn’t breathing, you can’t necessarily do CPR because you don’t have enough resources. You have to use your best judgment.

Meanwhile, the crashes kept coming. I found out later I was roughly vehicle No. 50 in the pileup; 83 more would follow. I heard them over and over – a crash and then screams from people in their vehicles. Each time a car hit, the entire pileup would move a couple of inches, getting more and more compacted. With that going on, I couldn’t go in there to pull people out. That scene was absolutely unsafe.

It felt like forever, but about 10 minutes later, an ambulance showed up, and I walked over to them. Because I was in my work uniform, they thought I was there on a call.

A couple fire crews came, and a firefighter yelled, “Hey, we need a backboard!” So, I grabbed a backboard from their unit and helped load up a patient. Then I heard somebody screaming, “This patient needs a stretcher!” A woman was having lumbar pain that seemed excruciating. I helped move her from the wreckage and carry her over to the stretcher. I started trying to get as many people as I could out of their cars.

Around this time, one of my supervisors showed up. He thought I was there working. But then he asked me, “Why is your face bleeding? Why do you have blood coming from your nose?” I pointed to my vehicle, and his jaw just dropped. He said, “Okay, you’re done. Go sit in my vehicle over there.”

He put a stop to my helping out, which was probably for the best. Because I actually had a concussion, a bone contusion in my foot, and a severely sprained ankle. The next day, I felt like I had gotten hit by a truck. (I had!) But when you have so much adrenaline pumping, you don’t feel pain or emotion. You don’t really feel anything.

While I was sitting in that vehicle, I called my mom to let her know I was okay. My parents were watching the news, and there was an aerial view of the accident. It was massive – a giant pile of metal stretching 200 or 300 yards. Six people had perished, more than 60 were hurt.

That night, our public information officer reached out to me about doing an interview with NBC. So, I told my story about what happened. Because of the concussion, a lot of it was a blur.

A day later, I got a call on my cell phone and someone said, “This is Tyler from Toyota. We saw the NBC interview. We wanted to let you know, don’t worry about getting a new vehicle. Just tell us what color 4Runner you want.”

My first thought was: Okay, this can’t be real. This doesn’t happen to people like me. But it turned out that it was, and they put me in a brand new vehicle.

Toyota started sending me to events like NASCAR races, putting me up in VIP suites. It was a cool experience. But it’s just surface stuff – it’s never going to erase what happened. The experience left a mark. It took me 6 months to a year to get rid of that feeling of the impact. Every time I tried to fall asleep, the whole scenario would replay in my head.

In EMS, we have a saying: “Every patient is practice for the next one.” That pileup – you can’t train for something like that. We all learned from it, so we can better prepare if anything like that happens again.

Since then, I’ve seen people die in motor vehicle collisions from a lot less than what happened to me. I’m not religious or spiritual, but I believe there must be a reason why I’m still here.

Now I see patients in traffic accidents who are very distraught even though they’re going to be okay. I tell them, “I’m sorry this happened to you. But remember, this is not the end. You are alive. And I’m going to do everything I can to make sure that doesn’t change while you’re with me.”
 

Trey McDaniel is a paramedic with MedStar Mobile Healthcare in Fort Worth, Tex.

A version of this article first appeared on Medscape.com.

It seemed like a typical kind of day. I was out the door by 6:00 a.m., heading into work for a shift on I-35 West, my daily commute. It was still dark out. A little bit colder that morning, but nothing us Texans aren’t used to.

I was cruising down the tollway, which is separated from the main highway by a barrier. That stretch has a slight hill and turns to the left. You can’t see anything beyond the hill when you’re at the bottom.

As I made my way up, I spotted brake lights about 400 yards ahead. I eased on my brake, and next thing I knew, I was sliding.

I realized, I’m on black ice.

I was driving a 2011 Toyota FJ Cruiser and I had it all beefed up – lift tires, winch bumpers front and back. I had never had any sort of issue like that.

My ABS brakes kicked in. I slowed, but not fast enough. I saw a wall of crashed cars in front of me.

I was in the left-hand lane, so I turned my steering wheel into the center median. I could hear the whole side of my vehicle scraping against it. I managed to slow down enough to just tap the vehicle in front of me.

I looked in my passenger side-view mirror and saw headlights coming in the right lane. But this car couldn’t slow down. It crashed into the wreckage to my right.

That’s when it sunk in: There was going to be a car coming in my lane, and it might not be able to stop.

I looked in my rear-view mirror and saw headlights. Sparks flying off that center median.

I didn’t know at the time, but it was a fully loaded semi-truck traveling about 60 miles an hour.

I had a split second to think: This is it. This is how it ends. I closed my eyes.

It was the most violent impact I’ve ever experienced in my life.

I had no idea until afterward, but I had slammed into the vehicle in front of me and my SUV did a kind of 360° barrel roll over the median into the northbound lanes, landing wheels down on top of my sheared off roof rack.

Everything stopped. I opened my eyes. All my airbags had deployed. I gently tried moving my arms and legs, and they worked. I couldn’t move my left foot. It was wedged underneath the brake pedal. But I wasn’t in any pain, just very confused and disoriented. I knew I needed to get out of the vehicle.

My door was wedged shut, so I crawled out of the broken window, slipping on the black ice. I realized I had hit a Fort Worth police cruiser, now all smashed up. The driver couldn’t open his door. So, I helped him force it open, got him out of the vehicle, and checked on him. He was fine.

I had no idea how many vehicles and people were involved. I was in so much shock that the only thing I could do was immediately revert back to my training. I was the only first responder there. No ambulances on scene yet, no fire. So, I did what I know how to do – except without any tools. I tried to triage as many people as I could.

I was helping people with lacerations, back and neck issues from the violent impacts. When you’re involved in a mass casualty incident like that, you have to assess which patients will be the most viable and need the most immediate attention. You have greens, yellows, reds, and then blacks – the deceased. Someone who doesn’t have a pulse and isn’t breathing, you can’t necessarily do CPR because you don’t have enough resources. You have to use your best judgment.

Meanwhile, the crashes kept coming. I found out later I was roughly vehicle No. 50 in the pileup; 83 more would follow. I heard them over and over – a crash and then screams from people in their vehicles. Each time a car hit, the entire pileup would move a couple of inches, getting more and more compacted. With that going on, I couldn’t go in there to pull people out. That scene was absolutely unsafe.

It felt like forever, but about 10 minutes later, an ambulance showed up, and I walked over to them. Because I was in my work uniform, they thought I was there on a call.

A couple fire crews came, and a firefighter yelled, “Hey, we need a backboard!” So, I grabbed a backboard from their unit and helped load up a patient. Then I heard somebody screaming, “This patient needs a stretcher!” A woman was having lumbar pain that seemed excruciating. I helped move her from the wreckage and carry her over to the stretcher. I started trying to get as many people as I could out of their cars.

Around this time, one of my supervisors showed up. He thought I was there working. But then he asked me, “Why is your face bleeding? Why do you have blood coming from your nose?” I pointed to my vehicle, and his jaw just dropped. He said, “Okay, you’re done. Go sit in my vehicle over there.”

He put a stop to my helping out, which was probably for the best. Because I actually had a concussion, a bone contusion in my foot, and a severely sprained ankle. The next day, I felt like I had gotten hit by a truck. (I had!) But when you have so much adrenaline pumping, you don’t feel pain or emotion. You don’t really feel anything.

While I was sitting in that vehicle, I called my mom to let her know I was okay. My parents were watching the news, and there was an aerial view of the accident. It was massive – a giant pile of metal stretching 200 or 300 yards. Six people had perished, more than 60 were hurt.

That night, our public information officer reached out to me about doing an interview with NBC. So, I told my story about what happened. Because of the concussion, a lot of it was a blur.

A day later, I got a call on my cell phone and someone said, “This is Tyler from Toyota. We saw the NBC interview. We wanted to let you know, don’t worry about getting a new vehicle. Just tell us what color 4Runner you want.”

My first thought was: Okay, this can’t be real. This doesn’t happen to people like me. But it turned out that it was, and they put me in a brand new vehicle.

Toyota started sending me to events like NASCAR races, putting me up in VIP suites. It was a cool experience. But it’s just surface stuff – it’s never going to erase what happened. The experience left a mark. It took me 6 months to a year to get rid of that feeling of the impact. Every time I tried to fall asleep, the whole scenario would replay in my head.

In EMS, we have a saying: “Every patient is practice for the next one.” That pileup – you can’t train for something like that. We all learned from it, so we can better prepare if anything like that happens again.

Since then, I’ve seen people die in motor vehicle collisions from a lot less than what happened to me. I’m not religious or spiritual, but I believe there must be a reason why I’m still here.

Now I see patients in traffic accidents who are very distraught even though they’re going to be okay. I tell them, “I’m sorry this happened to you. But remember, this is not the end. You are alive. And I’m going to do everything I can to make sure that doesn’t change while you’re with me.”
 

Trey McDaniel is a paramedic with MedStar Mobile Healthcare in Fort Worth, Tex.

A version of this article first appeared on Medscape.com.

It seemed like a typical kind of day. I was out the door by 6:00 a.m., heading into work for a shift on I-35 West, my daily commute. It was still dark out. A little bit colder that morning, but nothing us Texans aren’t used to.

I was cruising down the tollway, which is separated from the main highway by a barrier. That stretch has a slight hill and turns to the left. You can’t see anything beyond the hill when you’re at the bottom.

As I made my way up, I spotted brake lights about 400 yards ahead. I eased on my brake, and next thing I knew, I was sliding.

I realized, I’m on black ice.

I was driving a 2011 Toyota FJ Cruiser and I had it all beefed up – lift tires, winch bumpers front and back. I had never had any sort of issue like that.

My ABS brakes kicked in. I slowed, but not fast enough. I saw a wall of crashed cars in front of me.

I was in the left-hand lane, so I turned my steering wheel into the center median. I could hear the whole side of my vehicle scraping against it. I managed to slow down enough to just tap the vehicle in front of me.

I looked in my passenger side-view mirror and saw headlights coming in the right lane. But this car couldn’t slow down. It crashed into the wreckage to my right.

That’s when it sunk in: There was going to be a car coming in my lane, and it might not be able to stop.

I looked in my rear-view mirror and saw headlights. Sparks flying off that center median.

I didn’t know at the time, but it was a fully loaded semi-truck traveling about 60 miles an hour.

I had a split second to think: This is it. This is how it ends. I closed my eyes.

It was the most violent impact I’ve ever experienced in my life.

I had no idea until afterward, but I had slammed into the vehicle in front of me and my SUV did a kind of 360° barrel roll over the median into the northbound lanes, landing wheels down on top of my sheared off roof rack.

Everything stopped. I opened my eyes. All my airbags had deployed. I gently tried moving my arms and legs, and they worked. I couldn’t move my left foot. It was wedged underneath the brake pedal. But I wasn’t in any pain, just very confused and disoriented. I knew I needed to get out of the vehicle.

My door was wedged shut, so I crawled out of the broken window, slipping on the black ice. I realized I had hit a Fort Worth police cruiser, now all smashed up. The driver couldn’t open his door. So, I helped him force it open, got him out of the vehicle, and checked on him. He was fine.

I had no idea how many vehicles and people were involved. I was in so much shock that the only thing I could do was immediately revert back to my training. I was the only first responder there. No ambulances on scene yet, no fire. So, I did what I know how to do – except without any tools. I tried to triage as many people as I could.

I was helping people with lacerations, back and neck issues from the violent impacts. When you’re involved in a mass casualty incident like that, you have to assess which patients will be the most viable and need the most immediate attention. You have greens, yellows, reds, and then blacks – the deceased. Someone who doesn’t have a pulse and isn’t breathing, you can’t necessarily do CPR because you don’t have enough resources. You have to use your best judgment.

Meanwhile, the crashes kept coming. I found out later I was roughly vehicle No. 50 in the pileup; 83 more would follow. I heard them over and over – a crash and then screams from people in their vehicles. Each time a car hit, the entire pileup would move a couple of inches, getting more and more compacted. With that going on, I couldn’t go in there to pull people out. That scene was absolutely unsafe.

It felt like forever, but about 10 minutes later, an ambulance showed up, and I walked over to them. Because I was in my work uniform, they thought I was there on a call.

A couple fire crews came, and a firefighter yelled, “Hey, we need a backboard!” So, I grabbed a backboard from their unit and helped load up a patient. Then I heard somebody screaming, “This patient needs a stretcher!” A woman was having lumbar pain that seemed excruciating. I helped move her from the wreckage and carry her over to the stretcher. I started trying to get as many people as I could out of their cars.

Around this time, one of my supervisors showed up. He thought I was there working. But then he asked me, “Why is your face bleeding? Why do you have blood coming from your nose?” I pointed to my vehicle, and his jaw just dropped. He said, “Okay, you’re done. Go sit in my vehicle over there.”

He put a stop to my helping out, which was probably for the best. Because I actually had a concussion, a bone contusion in my foot, and a severely sprained ankle. The next day, I felt like I had gotten hit by a truck. (I had!) But when you have so much adrenaline pumping, you don’t feel pain or emotion. You don’t really feel anything.

While I was sitting in that vehicle, I called my mom to let her know I was okay. My parents were watching the news, and there was an aerial view of the accident. It was massive – a giant pile of metal stretching 200 or 300 yards. Six people had perished, more than 60 were hurt.

That night, our public information officer reached out to me about doing an interview with NBC. So, I told my story about what happened. Because of the concussion, a lot of it was a blur.

A day later, I got a call on my cell phone and someone said, “This is Tyler from Toyota. We saw the NBC interview. We wanted to let you know, don’t worry about getting a new vehicle. Just tell us what color 4Runner you want.”

My first thought was: Okay, this can’t be real. This doesn’t happen to people like me. But it turned out that it was, and they put me in a brand new vehicle.

Toyota started sending me to events like NASCAR races, putting me up in VIP suites. It was a cool experience. But it’s just surface stuff – it’s never going to erase what happened. The experience left a mark. It took me 6 months to a year to get rid of that feeling of the impact. Every time I tried to fall asleep, the whole scenario would replay in my head.

In EMS, we have a saying: “Every patient is practice for the next one.” That pileup – you can’t train for something like that. We all learned from it, so we can better prepare if anything like that happens again.

Since then, I’ve seen people die in motor vehicle collisions from a lot less than what happened to me. I’m not religious or spiritual, but I believe there must be a reason why I’m still here.

Now I see patients in traffic accidents who are very distraught even though they’re going to be okay. I tell them, “I’m sorry this happened to you. But remember, this is not the end. You are alive. And I’m going to do everything I can to make sure that doesn’t change while you’re with me.”
 

Trey McDaniel is a paramedic with MedStar Mobile Healthcare in Fort Worth, Tex.

A version of this article first appeared on Medscape.com.

Ashley Raibick is familiar with the weight loss yo-yo. She’s bounced through the big names: Weight Watchers, Jenny Craig, and so on. She drops 10 pounds and then slides off the plan only to see her weight pop back up.

But a day at her local med spa – where she gets facials, Botox, and fillers – changed all that for the 28-year-old hairstylist who just wanted to lose 18 pounds.

During one of her visits, she noticed that the spa’s owner was thinner. When Ms. Raibick asked her how she did it, the owner explained that she was on semaglutide and talked Ms. Raibick through the process. Ms. Raibick was convinced. That same day, she got a prescription from a doctor at the spa and got her first shot.

“Are people going to think I’m crazy for doing this?” she recalls thinking.

At 5 foot 4, her starting weight before the drug was 158, which would put her in the overweight, but not obese, category based on body mass index (BMI). And she really just wanted to get down to 140 and stop there.

Ozempic is part of an ever-growing group of GLP-1 receptor agonists that contain a peptide called semaglutide as its main ingredient. Although first meant to treat type 2 diabetes, the reputation of Ozempic and its siblings picked up when already-thin celebrities were suspected of using the injectable drugs to become even slimmer.

The FDA approved Ozempic’s cousin, Wegovy, for “weight management” in patients with obesity a few years ago, whereas Ozempic is currently approved only for diabetes treatment. Curious patients who don’t fit the criteria can – and do – get off-label prescriptions if they can afford to pay out of pocket, often to the tune of more than $1,400 a month. But is Ozempic worth it, especially if one has a relatively minor amount of weight to lose?

For many – mainly those who have been on the drug for a couple of months and have lost weight as a result – taking Ozempic has not only helped them shed stubborn weight, but has also freed them from the constant internal chatter around eating, commonly called “food noise.” But experts do not all agree that semaglutide is the right path for those who aren’t technically obese – especially in the long term.

After her first 9 weeks on semaglutide, Ms. Raibick had already lost 18 pounds. That’s when she decided to post about it on TikTok, and her videos on GLP-1s were viewed hundreds of thousands of times.

For the time being, there is no data on how many semaglutide takers are using the drug for diabetes and/or obesity, and how many are using it off-label for weight loss alone. But the company that makes Ozempic, Novo Nordisk, has reported sharp increases in sales and projects more profits down the road.

Ms. Raibick knows of others like her, who sought out the drug for more minor weight loss but aren’t as candid about their journeys. Some feel a stigma about having to resort to a weight-loss drug intended to treat obesity, rather than achieving their goals with diet and lifestyle change alone.

Another reason for the secrecy is the guilt some who take Ozempic feel about using their financial privilege to get a drug that had serious shortages, which made it harder for some patients who need the drug for diabetes or obesity treatment to get their doses.

That’s what Diana Thiara, MD, the medical director of the University of California, San Francisco’s weight management program, has been seeing on the ground.

“It’s one of the most depressing things I’ve experienced as a physician,” she said. In her practice, she has seen patients who have finally been able to access GLP-1s and have started to lose weight, only for them to regain the weight in the time it takes to find another prescription under their insurance coverage.

“It’s just horrible, there are patients spending all day calling dozens of pharmacies. I’ve never had a situation like this in my career,” said Dr. Thiara.

Ann, 48, a mom who works from home full-time, has been taking Ozempic since the end of January. (Ann is not her real name; she asked that we use a pseudonym in order to feel comfortable speaking publicly about her use of Ozempic). Like Ms. Raibick, she has been paying out of pocket for her shots. At first, she was going to have to pay $1,400 a month, but she found a pharmacy in Canada that offers the medication for $350. It’s sourced globally, she said, so sometimes her Ozempic boxes will be in Czech or another foreign language.

Unlike a lot of women, Ann never had any qualms with her weight or the way her body looked. She was never big on exercise, but it wasn’t until the pandemic that she started to gain weight. She noticed the changes in her body once places started opening back up, and her clothes didn’t fit anymore.

She tried moving more and eating healthier. She tried former Real Housewives of Beverly Hills cast member Teddi Mellencamp’s controversial weight-loss program, infamous for its incredibly restrictive dietary plan and excessive cardio recommendations. Nothing worked until another mom at her daughter’s school mentioned that she was on Ozempic.

Ann also started to get hot flashes and missed periods. The doctor who prescribed her Ozempic confirmed that she was perimenopausal and that, for women in this stage of life, losing weight can be harder than ever.

Ann, who is 5 foot 7, started out at 176 pounds (considered overweight) and now weighs in at 151, which is considered a normal weight by BMI measurements. She’s still on Ozempic but continues to struggle with the shame around the idea she’s potentially taking the drug away from someone else who might desperately need it. And she doesn’t know how long she’ll have to stay on Ozempic to maintain her weight loss.

Ann has reason for concern. A 2022 study found that most people regain the weight they lost within a year of stopping Ozempic.

Once Ms. Raibick hit her initial goal weight, she felt that she could keep going and lose a little more. It wasn’t until she got into the 120-pound range that she decided it was time to wean off the dose of semaglutide she had been taking.

“I got to the point where my mom was like, ‘All right, you’re a little too thin.’ But I’m just so happy where I’m at. I’m not mentally stressed out about fitting into clothes or getting into a bathing suit,” said Ms. Raibick, who has now lost around 30 pounds in total since she started the shots.

At one point, she stopped taking the drug altogether, and all of the hunger cravings and food noise semaglutide had suppressed came back to the surface. She didn’t gain any weight that month, she said, but the internal chatter around food was enough to make her start back on a lower dose, geared toward weight maintenance.

There’s also the issue of side effects. Ms. Raibick says she never had the overwhelming nausea and digestive problems that so many on the drug – including Ann – have reported. But Dr. Thiara said that even beyond these more common side effects, there are a number of other concerns – like the long-lasting effects on thyroid and reproductive health, especially for women – that we still don’t know enough about. And just recently, CNN reported that some Ozempic users have developed stomach paralysis due to the drug’s ability to slow down the passage of food through the digestive tract.

For Ms. Raibick, the out-of-pocket cost for the drug is around $600 a month. It’s an expense she’s willing to keep paying for, even just for the peace of mind the drug provides. She doesn’t have any plans to stop her semaglutide shots soon.

“There is nothing stopping me from – a year from now, when I’ve put a little weight back on – looking back at photos from this time and thinking I was way too skinny.”

Dan Azagury, MD, a bariatric surgeon and associate professor of surgery at Stanford (Calif.) University, tries GLP-1s for patients with obesity before considering bariatric surgery. For his patient population, it’s possible that drugs like Ozempic will be part of their lifelong treatment plans.

“We’re not doing it for the cosmetic part of it, we’re doing it for health,” he said. “What I tell my patients is, if you’re planning to start on this medication, you should be OK with the idea of staying on it forever.”

For doctors like Dr. Thiara who specialize in weight management, using Ozempic long-term for patients in a healthy weight range is the wrong approach.

“It’s not about the way people look, it’s about health. If you’re a normal weight or even in an overweight category, but not showing signs of risk of having elevated cardiometabolic disease ... You don’t need to be taking medications for weight loss,” she said. “This idea of using medications for aesthetic reasons is really more related to societal ills around how we value fitness above anything else. That’s not the goal, and it’s not safe.”

A version of this article first appeared on WebMD.com.

Ashley Raibick is familiar with the weight loss yo-yo. She’s bounced through the big names: Weight Watchers, Jenny Craig, and so on. She drops 10 pounds and then slides off the plan only to see her weight pop back up.

But a day at her local med spa – where she gets facials, Botox, and fillers – changed all that for the 28-year-old hairstylist who just wanted to lose 18 pounds.

During one of her visits, she noticed that the spa’s owner was thinner. When Ms. Raibick asked her how she did it, the owner explained that she was on semaglutide and talked Ms. Raibick through the process. Ms. Raibick was convinced. That same day, she got a prescription from a doctor at the spa and got her first shot.

“Are people going to think I’m crazy for doing this?” she recalls thinking.

At 5 foot 4, her starting weight before the drug was 158, which would put her in the overweight, but not obese, category based on body mass index (BMI). And she really just wanted to get down to 140 and stop there.

Ozempic is part of an ever-growing group of GLP-1 receptor agonists that contain a peptide called semaglutide as its main ingredient. Although first meant to treat type 2 diabetes, the reputation of Ozempic and its siblings picked up when already-thin celebrities were suspected of using the injectable drugs to become even slimmer.

The FDA approved Ozempic’s cousin, Wegovy, for “weight management” in patients with obesity a few years ago, whereas Ozempic is currently approved only for diabetes treatment. Curious patients who don’t fit the criteria can – and do – get off-label prescriptions if they can afford to pay out of pocket, often to the tune of more than $1,400 a month. But is Ozempic worth it, especially if one has a relatively minor amount of weight to lose?

For many – mainly those who have been on the drug for a couple of months and have lost weight as a result – taking Ozempic has not only helped them shed stubborn weight, but has also freed them from the constant internal chatter around eating, commonly called “food noise.” But experts do not all agree that semaglutide is the right path for those who aren’t technically obese – especially in the long term.

After her first 9 weeks on semaglutide, Ms. Raibick had already lost 18 pounds. That’s when she decided to post about it on TikTok, and her videos on GLP-1s were viewed hundreds of thousands of times.

For the time being, there is no data on how many semaglutide takers are using the drug for diabetes and/or obesity, and how many are using it off-label for weight loss alone. But the company that makes Ozempic, Novo Nordisk, has reported sharp increases in sales and projects more profits down the road.

Ms. Raibick knows of others like her, who sought out the drug for more minor weight loss but aren’t as candid about their journeys. Some feel a stigma about having to resort to a weight-loss drug intended to treat obesity, rather than achieving their goals with diet and lifestyle change alone.

Another reason for the secrecy is the guilt some who take Ozempic feel about using their financial privilege to get a drug that had serious shortages, which made it harder for some patients who need the drug for diabetes or obesity treatment to get their doses.

That’s what Diana Thiara, MD, the medical director of the University of California, San Francisco’s weight management program, has been seeing on the ground.

“It’s one of the most depressing things I’ve experienced as a physician,” she said. In her practice, she has seen patients who have finally been able to access GLP-1s and have started to lose weight, only for them to regain the weight in the time it takes to find another prescription under their insurance coverage.

“It’s just horrible, there are patients spending all day calling dozens of pharmacies. I’ve never had a situation like this in my career,” said Dr. Thiara.

Ann, 48, a mom who works from home full-time, has been taking Ozempic since the end of January. (Ann is not her real name; she asked that we use a pseudonym in order to feel comfortable speaking publicly about her use of Ozempic). Like Ms. Raibick, she has been paying out of pocket for her shots. At first, she was going to have to pay $1,400 a month, but she found a pharmacy in Canada that offers the medication for $350. It’s sourced globally, she said, so sometimes her Ozempic boxes will be in Czech or another foreign language.

Unlike a lot of women, Ann never had any qualms with her weight or the way her body looked. She was never big on exercise, but it wasn’t until the pandemic that she started to gain weight. She noticed the changes in her body once places started opening back up, and her clothes didn’t fit anymore.

She tried moving more and eating healthier. She tried former Real Housewives of Beverly Hills cast member Teddi Mellencamp’s controversial weight-loss program, infamous for its incredibly restrictive dietary plan and excessive cardio recommendations. Nothing worked until another mom at her daughter’s school mentioned that she was on Ozempic.

Ann also started to get hot flashes and missed periods. The doctor who prescribed her Ozempic confirmed that she was perimenopausal and that, for women in this stage of life, losing weight can be harder than ever.

Ann, who is 5 foot 7, started out at 176 pounds (considered overweight) and now weighs in at 151, which is considered a normal weight by BMI measurements. She’s still on Ozempic but continues to struggle with the shame around the idea she’s potentially taking the drug away from someone else who might desperately need it. And she doesn’t know how long she’ll have to stay on Ozempic to maintain her weight loss.

Ann has reason for concern. A 2022 study found that most people regain the weight they lost within a year of stopping Ozempic.

Once Ms. Raibick hit her initial goal weight, she felt that she could keep going and lose a little more. It wasn’t until she got into the 120-pound range that she decided it was time to wean off the dose of semaglutide she had been taking.

“I got to the point where my mom was like, ‘All right, you’re a little too thin.’ But I’m just so happy where I’m at. I’m not mentally stressed out about fitting into clothes or getting into a bathing suit,” said Ms. Raibick, who has now lost around 30 pounds in total since she started the shots.

At one point, she stopped taking the drug altogether, and all of the hunger cravings and food noise semaglutide had suppressed came back to the surface. She didn’t gain any weight that month, she said, but the internal chatter around food was enough to make her start back on a lower dose, geared toward weight maintenance.

There’s also the issue of side effects. Ms. Raibick says she never had the overwhelming nausea and digestive problems that so many on the drug – including Ann – have reported. But Dr. Thiara said that even beyond these more common side effects, there are a number of other concerns – like the long-lasting effects on thyroid and reproductive health, especially for women – that we still don’t know enough about. And just recently, CNN reported that some Ozempic users have developed stomach paralysis due to the drug’s ability to slow down the passage of food through the digestive tract.

For Ms. Raibick, the out-of-pocket cost for the drug is around $600 a month. It’s an expense she’s willing to keep paying for, even just for the peace of mind the drug provides. She doesn’t have any plans to stop her semaglutide shots soon.

“There is nothing stopping me from – a year from now, when I’ve put a little weight back on – looking back at photos from this time and thinking I was way too skinny.”

Dan Azagury, MD, a bariatric surgeon and associate professor of surgery at Stanford (Calif.) University, tries GLP-1s for patients with obesity before considering bariatric surgery. For his patient population, it’s possible that drugs like Ozempic will be part of their lifelong treatment plans.

“We’re not doing it for the cosmetic part of it, we’re doing it for health,” he said. “What I tell my patients is, if you’re planning to start on this medication, you should be OK with the idea of staying on it forever.”

For doctors like Dr. Thiara who specialize in weight management, using Ozempic long-term for patients in a healthy weight range is the wrong approach.

“It’s not about the way people look, it’s about health. If you’re a normal weight or even in an overweight category, but not showing signs of risk of having elevated cardiometabolic disease ... You don’t need to be taking medications for weight loss,” she said. “This idea of using medications for aesthetic reasons is really more related to societal ills around how we value fitness above anything else. That’s not the goal, and it’s not safe.”

A version of this article first appeared on WebMD.com.

Ashley Raibick is familiar with the weight loss yo-yo. She’s bounced through the big names: Weight Watchers, Jenny Craig, and so on. She drops 10 pounds and then slides off the plan only to see her weight pop back up.

But a day at her local med spa – where she gets facials, Botox, and fillers – changed all that for the 28-year-old hairstylist who just wanted to lose 18 pounds.

During one of her visits, she noticed that the spa’s owner was thinner. When Ms. Raibick asked her how she did it, the owner explained that she was on semaglutide and talked Ms. Raibick through the process. Ms. Raibick was convinced. That same day, she got a prescription from a doctor at the spa and got her first shot.

“Are people going to think I’m crazy for doing this?” she recalls thinking.

At 5 foot 4, her starting weight before the drug was 158, which would put her in the overweight, but not obese, category based on body mass index (BMI). And she really just wanted to get down to 140 and stop there.

Ozempic is part of an ever-growing group of GLP-1 receptor agonists that contain a peptide called semaglutide as its main ingredient. Although first meant to treat type 2 diabetes, the reputation of Ozempic and its siblings picked up when already-thin celebrities were suspected of using the injectable drugs to become even slimmer.

The FDA approved Ozempic’s cousin, Wegovy, for “weight management” in patients with obesity a few years ago, whereas Ozempic is currently approved only for diabetes treatment. Curious patients who don’t fit the criteria can – and do – get off-label prescriptions if they can afford to pay out of pocket, often to the tune of more than $1,400 a month. But is Ozempic worth it, especially if one has a relatively minor amount of weight to lose?

For many – mainly those who have been on the drug for a couple of months and have lost weight as a result – taking Ozempic has not only helped them shed stubborn weight, but has also freed them from the constant internal chatter around eating, commonly called “food noise.” But experts do not all agree that semaglutide is the right path for those who aren’t technically obese – especially in the long term.

After her first 9 weeks on semaglutide, Ms. Raibick had already lost 18 pounds. That’s when she decided to post about it on TikTok, and her videos on GLP-1s were viewed hundreds of thousands of times.

For the time being, there is no data on how many semaglutide takers are using the drug for diabetes and/or obesity, and how many are using it off-label for weight loss alone. But the company that makes Ozempic, Novo Nordisk, has reported sharp increases in sales and projects more profits down the road.

Ms. Raibick knows of others like her, who sought out the drug for more minor weight loss but aren’t as candid about their journeys. Some feel a stigma about having to resort to a weight-loss drug intended to treat obesity, rather than achieving their goals with diet and lifestyle change alone.

Another reason for the secrecy is the guilt some who take Ozempic feel about using their financial privilege to get a drug that had serious shortages, which made it harder for some patients who need the drug for diabetes or obesity treatment to get their doses.

That’s what Diana Thiara, MD, the medical director of the University of California, San Francisco’s weight management program, has been seeing on the ground.

“It’s one of the most depressing things I’ve experienced as a physician,” she said. In her practice, she has seen patients who have finally been able to access GLP-1s and have started to lose weight, only for them to regain the weight in the time it takes to find another prescription under their insurance coverage.

“It’s just horrible, there are patients spending all day calling dozens of pharmacies. I’ve never had a situation like this in my career,” said Dr. Thiara.

Ann, 48, a mom who works from home full-time, has been taking Ozempic since the end of January. (Ann is not her real name; she asked that we use a pseudonym in order to feel comfortable speaking publicly about her use of Ozempic). Like Ms. Raibick, she has been paying out of pocket for her shots. At first, she was going to have to pay $1,400 a month, but she found a pharmacy in Canada that offers the medication for $350. It’s sourced globally, she said, so sometimes her Ozempic boxes will be in Czech or another foreign language.

Unlike a lot of women, Ann never had any qualms with her weight or the way her body looked. She was never big on exercise, but it wasn’t until the pandemic that she started to gain weight. She noticed the changes in her body once places started opening back up, and her clothes didn’t fit anymore.

She tried moving more and eating healthier. She tried former Real Housewives of Beverly Hills cast member Teddi Mellencamp’s controversial weight-loss program, infamous for its incredibly restrictive dietary plan and excessive cardio recommendations. Nothing worked until another mom at her daughter’s school mentioned that she was on Ozempic.

Ann also started to get hot flashes and missed periods. The doctor who prescribed her Ozempic confirmed that she was perimenopausal and that, for women in this stage of life, losing weight can be harder than ever.

Ann, who is 5 foot 7, started out at 176 pounds (considered overweight) and now weighs in at 151, which is considered a normal weight by BMI measurements. She’s still on Ozempic but continues to struggle with the shame around the idea she’s potentially taking the drug away from someone else who might desperately need it. And she doesn’t know how long she’ll have to stay on Ozempic to maintain her weight loss.

Ann has reason for concern. A 2022 study found that most people regain the weight they lost within a year of stopping Ozempic.

Once Ms. Raibick hit her initial goal weight, she felt that she could keep going and lose a little more. It wasn’t until she got into the 120-pound range that she decided it was time to wean off the dose of semaglutide she had been taking.

“I got to the point where my mom was like, ‘All right, you’re a little too thin.’ But I’m just so happy where I’m at. I’m not mentally stressed out about fitting into clothes or getting into a bathing suit,” said Ms. Raibick, who has now lost around 30 pounds in total since she started the shots.

At one point, she stopped taking the drug altogether, and all of the hunger cravings and food noise semaglutide had suppressed came back to the surface. She didn’t gain any weight that month, she said, but the internal chatter around food was enough to make her start back on a lower dose, geared toward weight maintenance.

There’s also the issue of side effects. Ms. Raibick says she never had the overwhelming nausea and digestive problems that so many on the drug – including Ann – have reported. But Dr. Thiara said that even beyond these more common side effects, there are a number of other concerns – like the long-lasting effects on thyroid and reproductive health, especially for women – that we still don’t know enough about. And just recently, CNN reported that some Ozempic users have developed stomach paralysis due to the drug’s ability to slow down the passage of food through the digestive tract.

For Ms. Raibick, the out-of-pocket cost for the drug is around $600 a month. It’s an expense she’s willing to keep paying for, even just for the peace of mind the drug provides. She doesn’t have any plans to stop her semaglutide shots soon.

“There is nothing stopping me from – a year from now, when I’ve put a little weight back on – looking back at photos from this time and thinking I was way too skinny.”

Dan Azagury, MD, a bariatric surgeon and associate professor of surgery at Stanford (Calif.) University, tries GLP-1s for patients with obesity before considering bariatric surgery. For his patient population, it’s possible that drugs like Ozempic will be part of their lifelong treatment plans.

“We’re not doing it for the cosmetic part of it, we’re doing it for health,” he said. “What I tell my patients is, if you’re planning to start on this medication, you should be OK with the idea of staying on it forever.”

For doctors like Dr. Thiara who specialize in weight management, using Ozempic long-term for patients in a healthy weight range is the wrong approach.

“It’s not about the way people look, it’s about health. If you’re a normal weight or even in an overweight category, but not showing signs of risk of having elevated cardiometabolic disease ... You don’t need to be taking medications for weight loss,” she said. “This idea of using medications for aesthetic reasons is really more related to societal ills around how we value fitness above anything else. That’s not the goal, and it’s not safe.”

A version of this article first appeared on WebMD.com.

Researchers in Texas are developing a “green light” technology they hope will solve a crucial problem highlighted by the pandemic: the limits of pulse oximeters in patients with darker skin.

A recent study adds weight to earlier findings that their device works. 

“It is a new, first-in-class technology,” said Sanjay Gokhale, MD, the bioengineer who is leading this research at the University of Texas at Arlington. “The team conducted extensive preclinical work and carried out phase 1 studies in human volunteers, demonstrating sensitivity and accuracy.”

It’s one of several projects underway to update pulse oximetry, a technology based on research in lighter-skinned people that has not changed much in 50 years. 

The pulse oximeter, or “pulse ox,” measures the saturation of oxygen in your hemoglobin (a protein in red blood cells). But it tends to overestimate the oxygen saturation in patients with darker skin by about 2%-3%. That may not sound like a lot, but it’s enough to delay major treatment for respiratory issues like COVID-19. 

“Falsely elevated readings from commercial oximeters have delayed treatment of Black COVID-19 patients for hours in some cases,” said Divya Chander, MD, PhD, an anesthesiologist in Oakland, Calif., and chair of neuroscience at The Singularity Group. (Dr. Chander was not involved in the UT Arlington research.)

Early research happening separately at Brown University and Tufts University aims to redesign the pulse oximeter to get accurate readings in patients of all skin tones. University of California, San Diego, researchers are looking into a method that measures blood oxygen using sound in combination with light.  Other solutions try to correct for skin tone with algorithms. 

The device from UT Arlington uses an algorithm too, but its main innovation is that it replaces red light with green light. 
 

Red light, green light

Traditional oximetry devices, which typically clip on to the patient’s fingertip, use LEDs to beam light through the skin at two wavelengths: one in the red part of the spectrum, the other in the infrared. The light transmits from one side of the clip to the other, passing through arterial blood as it pulses.

The device calculates a patient’s oxygenation based on how much light of each wavelength is absorbed by hemoglobin in the blood. Oxygenated hemoglobin absorbs the light differently than deoxygenated hemoglobin, so oxygenation can be represented as a percentage; 100% means all hemoglobin is completely oxygenated.  But the melanin in skin can interfere with the absorption of light and affect the results. 

The green light strategy measures not absorption but reflectance – how much of the light bounces back. As with traditional oximetry, the green-light method uses two wavelengths. Each is a different shade of green, and the two forms of hemoglobin reflect them differently. 

Using an algorithm developed by the researchers, the device can capture readings in patients of all skin tones, the researchers say. And because it works on the wrist rather than a finger, the device also eliminates issues with cold fingers and dark nail polish – both known to reduce accuracy in traditional oximetry.

In the latest experiments, the researchers tested the technology on synthetic skin samples with varying amounts of melanin, Dr. Gokhale said. The device picked up changes in blood oxygen saturation even in samples with high melanin levels. 

In a study published last year, the technology was tested in 16 people against an invasive handheld blood analyzer and a noninvasive commercial pulse oximeter, and found to be comparable to the invasive method. 
 

A drawback 

The green light approach could be “game changing,” Dr. Chander said. But there is a drawback. 

Since green light doesn’t penetrate as deeply, this approach measures blood oxygen saturation in capillary beds (small blood vessels very close to the skin surface). By contrast, traditional oximetry measures oxygen saturation in an artery as it pulses – thus the name pulse oximetry. 

Valuable information can be obtained from an arterial pulse.

Changes in arterial pulse, known as the waveforms, “can tell us about a patient’s hydration status [for instance],” Dr. Chander said. “In a mechanically ventilated patient, this variation with a patient’s respiratory cycle can give us feedback about how responsive the patient will be to fluid resuscitation if their blood pressure is too low.” 

Given such considerations, the green light method may be useful as an adjunct, not a full replacement, to a standard pulse ox, Dr. Chander noted.

A version of this article appeared on WebMD.com.

Researchers in Texas are developing a “green light” technology they hope will solve a crucial problem highlighted by the pandemic: the limits of pulse oximeters in patients with darker skin.

A recent study adds weight to earlier findings that their device works. 

“It is a new, first-in-class technology,” said Sanjay Gokhale, MD, the bioengineer who is leading this research at the University of Texas at Arlington. “The team conducted extensive preclinical work and carried out phase 1 studies in human volunteers, demonstrating sensitivity and accuracy.”

It’s one of several projects underway to update pulse oximetry, a technology based on research in lighter-skinned people that has not changed much in 50 years. 

The pulse oximeter, or “pulse ox,” measures the saturation of oxygen in your hemoglobin (a protein in red blood cells). But it tends to overestimate the oxygen saturation in patients with darker skin by about 2%-3%. That may not sound like a lot, but it’s enough to delay major treatment for respiratory issues like COVID-19. 

“Falsely elevated readings from commercial oximeters have delayed treatment of Black COVID-19 patients for hours in some cases,” said Divya Chander, MD, PhD, an anesthesiologist in Oakland, Calif., and chair of neuroscience at The Singularity Group. (Dr. Chander was not involved in the UT Arlington research.)

Early research happening separately at Brown University and Tufts University aims to redesign the pulse oximeter to get accurate readings in patients of all skin tones. University of California, San Diego, researchers are looking into a method that measures blood oxygen using sound in combination with light.  Other solutions try to correct for skin tone with algorithms. 

The device from UT Arlington uses an algorithm too, but its main innovation is that it replaces red light with green light. 
 

Red light, green light

Traditional oximetry devices, which typically clip on to the patient’s fingertip, use LEDs to beam light through the skin at two wavelengths: one in the red part of the spectrum, the other in the infrared. The light transmits from one side of the clip to the other, passing through arterial blood as it pulses.

The device calculates a patient’s oxygenation based on how much light of each wavelength is absorbed by hemoglobin in the blood. Oxygenated hemoglobin absorbs the light differently than deoxygenated hemoglobin, so oxygenation can be represented as a percentage; 100% means all hemoglobin is completely oxygenated.  But the melanin in skin can interfere with the absorption of light and affect the results. 

The green light strategy measures not absorption but reflectance – how much of the light bounces back. As with traditional oximetry, the green-light method uses two wavelengths. Each is a different shade of green, and the two forms of hemoglobin reflect them differently. 

Using an algorithm developed by the researchers, the device can capture readings in patients of all skin tones, the researchers say. And because it works on the wrist rather than a finger, the device also eliminates issues with cold fingers and dark nail polish – both known to reduce accuracy in traditional oximetry.

In the latest experiments, the researchers tested the technology on synthetic skin samples with varying amounts of melanin, Dr. Gokhale said. The device picked up changes in blood oxygen saturation even in samples with high melanin levels. 

In a study published last year, the technology was tested in 16 people against an invasive handheld blood analyzer and a noninvasive commercial pulse oximeter, and found to be comparable to the invasive method. 
 

A drawback 

The green light approach could be “game changing,” Dr. Chander said. But there is a drawback. 

Since green light doesn’t penetrate as deeply, this approach measures blood oxygen saturation in capillary beds (small blood vessels very close to the skin surface). By contrast, traditional oximetry measures oxygen saturation in an artery as it pulses – thus the name pulse oximetry. 

Valuable information can be obtained from an arterial pulse.

Changes in arterial pulse, known as the waveforms, “can tell us about a patient’s hydration status [for instance],” Dr. Chander said. “In a mechanically ventilated patient, this variation with a patient’s respiratory cycle can give us feedback about how responsive the patient will be to fluid resuscitation if their blood pressure is too low.” 

Given such considerations, the green light method may be useful as an adjunct, not a full replacement, to a standard pulse ox, Dr. Chander noted.

A version of this article appeared on WebMD.com.

Researchers in Texas are developing a “green light” technology they hope will solve a crucial problem highlighted by the pandemic: the limits of pulse oximeters in patients with darker skin.

A recent study adds weight to earlier findings that their device works. 

“It is a new, first-in-class technology,” said Sanjay Gokhale, MD, the bioengineer who is leading this research at the University of Texas at Arlington. “The team conducted extensive preclinical work and carried out phase 1 studies in human volunteers, demonstrating sensitivity and accuracy.”

It’s one of several projects underway to update pulse oximetry, a technology based on research in lighter-skinned people that has not changed much in 50 years. 

The pulse oximeter, or “pulse ox,” measures the saturation of oxygen in your hemoglobin (a protein in red blood cells). But it tends to overestimate the oxygen saturation in patients with darker skin by about 2%-3%. That may not sound like a lot, but it’s enough to delay major treatment for respiratory issues like COVID-19. 

“Falsely elevated readings from commercial oximeters have delayed treatment of Black COVID-19 patients for hours in some cases,” said Divya Chander, MD, PhD, an anesthesiologist in Oakland, Calif., and chair of neuroscience at The Singularity Group. (Dr. Chander was not involved in the UT Arlington research.)

Early research happening separately at Brown University and Tufts University aims to redesign the pulse oximeter to get accurate readings in patients of all skin tones. University of California, San Diego, researchers are looking into a method that measures blood oxygen using sound in combination with light.  Other solutions try to correct for skin tone with algorithms. 

The device from UT Arlington uses an algorithm too, but its main innovation is that it replaces red light with green light. 
 

Red light, green light

Traditional oximetry devices, which typically clip on to the patient’s fingertip, use LEDs to beam light through the skin at two wavelengths: one in the red part of the spectrum, the other in the infrared. The light transmits from one side of the clip to the other, passing through arterial blood as it pulses.

The device calculates a patient’s oxygenation based on how much light of each wavelength is absorbed by hemoglobin in the blood. Oxygenated hemoglobin absorbs the light differently than deoxygenated hemoglobin, so oxygenation can be represented as a percentage; 100% means all hemoglobin is completely oxygenated.  But the melanin in skin can interfere with the absorption of light and affect the results. 

The green light strategy measures not absorption but reflectance – how much of the light bounces back. As with traditional oximetry, the green-light method uses two wavelengths. Each is a different shade of green, and the two forms of hemoglobin reflect them differently. 

Using an algorithm developed by the researchers, the device can capture readings in patients of all skin tones, the researchers say. And because it works on the wrist rather than a finger, the device also eliminates issues with cold fingers and dark nail polish – both known to reduce accuracy in traditional oximetry.

In the latest experiments, the researchers tested the technology on synthetic skin samples with varying amounts of melanin, Dr. Gokhale said. The device picked up changes in blood oxygen saturation even in samples with high melanin levels. 

In a study published last year, the technology was tested in 16 people against an invasive handheld blood analyzer and a noninvasive commercial pulse oximeter, and found to be comparable to the invasive method. 
 

A drawback 

The green light approach could be “game changing,” Dr. Chander said. But there is a drawback. 

Since green light doesn’t penetrate as deeply, this approach measures blood oxygen saturation in capillary beds (small blood vessels very close to the skin surface). By contrast, traditional oximetry measures oxygen saturation in an artery as it pulses – thus the name pulse oximetry. 

Valuable information can be obtained from an arterial pulse.

Changes in arterial pulse, known as the waveforms, “can tell us about a patient’s hydration status [for instance],” Dr. Chander said. “In a mechanically ventilated patient, this variation with a patient’s respiratory cycle can give us feedback about how responsive the patient will be to fluid resuscitation if their blood pressure is too low.” 

Given such considerations, the green light method may be useful as an adjunct, not a full replacement, to a standard pulse ox, Dr. Chander noted.

A version of this article appeared on WebMD.com.

A growing number of long COVID patients, denied disability benefits despite being unable to work, are turning to the courts for legal relief.

At least 30 lawsuits have been filed seeking legal resolution of disability insurance claims, according to searches of court records. In addition, the Social Security Administration said it has received about 52,000 disability claims tied to SARS-CoV-2 infections, which represents 1% of all applications.

But legal experts say those cases may not reflect the total number of cases that have gone to court. They note many claims are initially dismissed and are not appealed by claimants.

“With this system, they deny two-thirds of initial applications, then people who appeal get denied almost 90% of the time, and then they can appeal before a judge,” said Kevin LaPorte, a Social Security disability attorney at LaPorte Law Firm in Oakland, Calif. “What happens next doesn’t have a lot of precedent because long COVID is a mass disabling event, and we haven’t seen that many of these cases get all the way through the legal system yet.”

As a result, the exact number of long COVID disability claims and the number of these cases going to court isn’t clear, he said.

“It can take a year or more for cases to get to court, and even longer to reach resolution,” Mr. LaPorte added. “I suspect the few cases we’ve heard about at this point are going to be the tip of the iceberg.”

The process is convoluted and can drag on for months with multiple denials and appeals along the way. Many disabled workers find their only recourse is to take insurers to court.

Long COVID patients typically apply for disability benefits through private insurance or Social Security. But the process can drag on for months, so many find their only recourse is to take insurers to court, according to legal experts.

But even in the courts, many encounter delays and hurdles to resolution.

In one of the first federal lawsuits involving long COVID disability benefits, William Abrams, a trial and appellate attorney and active marathon runner, sued Unum Life Insurance seeking long-term disability income. Symptoms included extreme fatigue, brain fog, decreased attention and concentration, and nearly daily fevers, causing him to stop working in April 2020.

His diagnosis wasn’t definitive. Three doctors said he had long COVID, and four said he had chronic fatigue syndrome. Unum cited this inconsistency as a rationale for rejecting his claim. But the court sided with Mr. Abrams, granting him disability income. The court concluded: “Unum may be correct that [the plaintiff] has not been correctly diagnosed. But that does not mean he is not sick. If [the plaintiff’s] complaints, and [the doctor’s] assessments, are to be believed, [the plaintiff] cannot focus for more than a few minutes at a time, making it impossible for [the plaintiff] to perform the varied and complex tasks his job requires.”

Unum said in an emailed statement that the company doesn’t comment on specific claims as a matter of policy, adding that its total payouts for disability claims from March 2020 to February 2022 were 35% higher than prepandemic levels. “In general, disability and leave claims connected to COVID-19 have been primarily short-term events with the majority of claimants recovering prior to completing the normal qualification period for long-term disability insurance,” Unum said.

Mr. Abrams prevailed in part because he had detailed documentation of the numerous impairments that eventually required him to stop work, said Michelle Roberts of Roberts Disability Law in Oakland, Calif.

He submitted videos of himself taking his temperature to prove he had almost daily fevers, according to court records. He underwent neuropsychological testing, which found learning deficiencies and memory deficits.

Mr. Abrams also submitted statements from a colleague who worked with him on a complex technology patent case involving radiofrequency identification. Before he got COVID, Mr. Abrams “had the analytical ability, legal acumen, and mental energy to attack that learning curve and get up to speed very rapidly,” according to court records.

“The court focused on credulity.” Ms. Roberts said. “There was all this work to be done to show this person was high functioning and ran marathons and worked in an intense, high-pressure occupation but then couldn’t do anything after long COVID.”

Documentation was also crucial in another early federal long COVID disability lawsuit that was filed in 2022 on behalf of Wendy Haut, an educational software sales representative in California who turned to the courts seeking disability income through her company’s employee benefits plan.

Several of Ms. Haut’s doctors documented a detailed list of long COVID symptoms, including “profound fatigue and extreme cognitive difficulties,” that they said prevented her from working as a sales representative or doing any other type of job. A settlement agreement in June 2022 required Reliance Standard Life Insurance to pay Ms. Haut long-term disability benefits, including previously unpaid benefits, according to a report by the advocacy group Pandemic Patients.

Representatives of Reliance Standard didn’t respond to a request for comment.

The growing number of workers being sidelined by long COVID makes more claims and more court cases likely. Right now, an estimated 16 million working-age Americans aged 18-65 years have long COVID, and as many as 4 million of them can’t work, according to a July 2023 Census Bureau report.

Uncertainty about the volume of claims in the pipeline is part of what’s driving some insurers to fight long COVID claims, Ms. Roberts said. Another factor is the lack of clarity around how many years people with long COVID may be out of work, particularly if they’re in their 30s or 40s and might be seeking disability income until they reach retirement age.

“Doctors are not always saying that this person will be permanently disabled,” Ms. Roberts said. “If this person doesn’t get better and they’re disabled until retirement age, this could be a payout in the high six or seven figures if a person is very young and was a very high earner.”

Insurance companies routinely deny claims that can’t be backed up with objective measures, such as specific lab test results or clear findings from a physical exam. But there are steps that can increase the odds of a successful claim for long COVID disability benefits, according to New York–based law firm Hiller.

For starters, patients can document COVID test results, and if testing wasn’t conducted, patients can detail the specific symptoms that led to this diagnosis, Hiller advises. Then patients can keep a daily symptom log at home that run lists all of the specific symptoms that occur at different times during the day and night to help establish a pattern of disability. These logs should provide specific details about every job duty patients have and exactly how specific symptoms of long COVID interfere with these duties.

Even though objective testing is hard to come by for long COVID, people should undergo all the tests they can that may help document the frequency or severity of specific symptoms that make it impossible to carry on with business as usual at work, Hiller advises. This may include neuropsychological testing to document brain fog, a cardiopulmonary exercise test to demonstrate chronic fatigue and the inability to exercise, or a tilt table test to measure dizziness.

Seeking a doctor’s diagnosis can be key to collecting disability payments, in or out of court.

All of this puts a lot of pressure on doctors and patients to build strong cases, said Jonathan Whiteson, MD, codirector of the NYU Langone Health post-COVID care program in New York. “Many physicians are not familiar with the disability benefit paperwork, and so this is a challenge for the doctors to know how to complete and to build the time into their highly scheduled days to take the time needed to complete.

“It’s also challenging because most of the disability benefit forms are ‘generic’ and do not ask specific questions about COVID disability,” Dr. Whiteson added. “It can be like trying to drive a square peg into a round hole.”

Still, when it comes to long COVID, completing disability paperwork is increasingly becoming part of standard care, along with managing medication, rehabilitation therapies, and lifestyle changes to navigate daily life with this illness, Dr. Whiteson noted.

Monica Verduzco-Gutierrez, MD, chair of rehabilitation medicine and director of the Post-COVID-19 Recovery Clinic at the University of Texas Health Science Center, San Antonio, agreed with this assessment.

“I have done letter upon letter of appeal to disability insurance companies,” she said.

Some doctors, however, are reluctant to step up in such cases, in part because no standard diagnostic guidelines exist for long COVID and because it can be frustrating.

“This is the work that is not paid and causes burnout in physicians,” Dr. Verduzco-Gutierrez said. “The paperwork, the fighting with insurance companies, the resubmission of forms for disability all to get what your patient needs – and then it gets denied.

“We will keep doing this because our patients need this disability income in order to live their lives and to afford what they need for recovery,” said Dr. Verduzco-Gutierrez. “But at some point something has to change because this isn’t sustainable.”

A version of this article appeared on Medscape.com.

A growing number of long COVID patients, denied disability benefits despite being unable to work, are turning to the courts for legal relief.

At least 30 lawsuits have been filed seeking legal resolution of disability insurance claims, according to searches of court records. In addition, the Social Security Administration said it has received about 52,000 disability claims tied to SARS-CoV-2 infections, which represents 1% of all applications.

But legal experts say those cases may not reflect the total number of cases that have gone to court. They note many claims are initially dismissed and are not appealed by claimants.

“With this system, they deny two-thirds of initial applications, then people who appeal get denied almost 90% of the time, and then they can appeal before a judge,” said Kevin LaPorte, a Social Security disability attorney at LaPorte Law Firm in Oakland, Calif. “What happens next doesn’t have a lot of precedent because long COVID is a mass disabling event, and we haven’t seen that many of these cases get all the way through the legal system yet.”

As a result, the exact number of long COVID disability claims and the number of these cases going to court isn’t clear, he said.

“It can take a year or more for cases to get to court, and even longer to reach resolution,” Mr. LaPorte added. “I suspect the few cases we’ve heard about at this point are going to be the tip of the iceberg.”

The process is convoluted and can drag on for months with multiple denials and appeals along the way. Many disabled workers find their only recourse is to take insurers to court.

Long COVID patients typically apply for disability benefits through private insurance or Social Security. But the process can drag on for months, so many find their only recourse is to take insurers to court, according to legal experts.

But even in the courts, many encounter delays and hurdles to resolution.

In one of the first federal lawsuits involving long COVID disability benefits, William Abrams, a trial and appellate attorney and active marathon runner, sued Unum Life Insurance seeking long-term disability income. Symptoms included extreme fatigue, brain fog, decreased attention and concentration, and nearly daily fevers, causing him to stop working in April 2020.

His diagnosis wasn’t definitive. Three doctors said he had long COVID, and four said he had chronic fatigue syndrome. Unum cited this inconsistency as a rationale for rejecting his claim. But the court sided with Mr. Abrams, granting him disability income. The court concluded: “Unum may be correct that [the plaintiff] has not been correctly diagnosed. But that does not mean he is not sick. If [the plaintiff’s] complaints, and [the doctor’s] assessments, are to be believed, [the plaintiff] cannot focus for more than a few minutes at a time, making it impossible for [the plaintiff] to perform the varied and complex tasks his job requires.”

Unum said in an emailed statement that the company doesn’t comment on specific claims as a matter of policy, adding that its total payouts for disability claims from March 2020 to February 2022 were 35% higher than prepandemic levels. “In general, disability and leave claims connected to COVID-19 have been primarily short-term events with the majority of claimants recovering prior to completing the normal qualification period for long-term disability insurance,” Unum said.

Mr. Abrams prevailed in part because he had detailed documentation of the numerous impairments that eventually required him to stop work, said Michelle Roberts of Roberts Disability Law in Oakland, Calif.

He submitted videos of himself taking his temperature to prove he had almost daily fevers, according to court records. He underwent neuropsychological testing, which found learning deficiencies and memory deficits.

Mr. Abrams also submitted statements from a colleague who worked with him on a complex technology patent case involving radiofrequency identification. Before he got COVID, Mr. Abrams “had the analytical ability, legal acumen, and mental energy to attack that learning curve and get up to speed very rapidly,” according to court records.

“The court focused on credulity.” Ms. Roberts said. “There was all this work to be done to show this person was high functioning and ran marathons and worked in an intense, high-pressure occupation but then couldn’t do anything after long COVID.”

Documentation was also crucial in another early federal long COVID disability lawsuit that was filed in 2022 on behalf of Wendy Haut, an educational software sales representative in California who turned to the courts seeking disability income through her company’s employee benefits plan.

Several of Ms. Haut’s doctors documented a detailed list of long COVID symptoms, including “profound fatigue and extreme cognitive difficulties,” that they said prevented her from working as a sales representative or doing any other type of job. A settlement agreement in June 2022 required Reliance Standard Life Insurance to pay Ms. Haut long-term disability benefits, including previously unpaid benefits, according to a report by the advocacy group Pandemic Patients.

Representatives of Reliance Standard didn’t respond to a request for comment.

The growing number of workers being sidelined by long COVID makes more claims and more court cases likely. Right now, an estimated 16 million working-age Americans aged 18-65 years have long COVID, and as many as 4 million of them can’t work, according to a July 2023 Census Bureau report.

Uncertainty about the volume of claims in the pipeline is part of what’s driving some insurers to fight long COVID claims, Ms. Roberts said. Another factor is the lack of clarity around how many years people with long COVID may be out of work, particularly if they’re in their 30s or 40s and might be seeking disability income until they reach retirement age.

“Doctors are not always saying that this person will be permanently disabled,” Ms. Roberts said. “If this person doesn’t get better and they’re disabled until retirement age, this could be a payout in the high six or seven figures if a person is very young and was a very high earner.”

Insurance companies routinely deny claims that can’t be backed up with objective measures, such as specific lab test results or clear findings from a physical exam. But there are steps that can increase the odds of a successful claim for long COVID disability benefits, according to New York–based law firm Hiller.

For starters, patients can document COVID test results, and if testing wasn’t conducted, patients can detail the specific symptoms that led to this diagnosis, Hiller advises. Then patients can keep a daily symptom log at home that run lists all of the specific symptoms that occur at different times during the day and night to help establish a pattern of disability. These logs should provide specific details about every job duty patients have and exactly how specific symptoms of long COVID interfere with these duties.

Even though objective testing is hard to come by for long COVID, people should undergo all the tests they can that may help document the frequency or severity of specific symptoms that make it impossible to carry on with business as usual at work, Hiller advises. This may include neuropsychological testing to document brain fog, a cardiopulmonary exercise test to demonstrate chronic fatigue and the inability to exercise, or a tilt table test to measure dizziness.

Seeking a doctor’s diagnosis can be key to collecting disability payments, in or out of court.

All of this puts a lot of pressure on doctors and patients to build strong cases, said Jonathan Whiteson, MD, codirector of the NYU Langone Health post-COVID care program in New York. “Many physicians are not familiar with the disability benefit paperwork, and so this is a challenge for the doctors to know how to complete and to build the time into their highly scheduled days to take the time needed to complete.

“It’s also challenging because most of the disability benefit forms are ‘generic’ and do not ask specific questions about COVID disability,” Dr. Whiteson added. “It can be like trying to drive a square peg into a round hole.”

Still, when it comes to long COVID, completing disability paperwork is increasingly becoming part of standard care, along with managing medication, rehabilitation therapies, and lifestyle changes to navigate daily life with this illness, Dr. Whiteson noted.

Monica Verduzco-Gutierrez, MD, chair of rehabilitation medicine and director of the Post-COVID-19 Recovery Clinic at the University of Texas Health Science Center, San Antonio, agreed with this assessment.

“I have done letter upon letter of appeal to disability insurance companies,” she said.

Some doctors, however, are reluctant to step up in such cases, in part because no standard diagnostic guidelines exist for long COVID and because it can be frustrating.

“This is the work that is not paid and causes burnout in physicians,” Dr. Verduzco-Gutierrez said. “The paperwork, the fighting with insurance companies, the resubmission of forms for disability all to get what your patient needs – and then it gets denied.

“We will keep doing this because our patients need this disability income in order to live their lives and to afford what they need for recovery,” said Dr. Verduzco-Gutierrez. “But at some point something has to change because this isn’t sustainable.”

A version of this article appeared on Medscape.com.

A growing number of long COVID patients, denied disability benefits despite being unable to work, are turning to the courts for legal relief.

At least 30 lawsuits have been filed seeking legal resolution of disability insurance claims, according to searches of court records. In addition, the Social Security Administration said it has received about 52,000 disability claims tied to SARS-CoV-2 infections, which represents 1% of all applications.

But legal experts say those cases may not reflect the total number of cases that have gone to court. They note many claims are initially dismissed and are not appealed by claimants.

“With this system, they deny two-thirds of initial applications, then people who appeal get denied almost 90% of the time, and then they can appeal before a judge,” said Kevin LaPorte, a Social Security disability attorney at LaPorte Law Firm in Oakland, Calif. “What happens next doesn’t have a lot of precedent because long COVID is a mass disabling event, and we haven’t seen that many of these cases get all the way through the legal system yet.”

As a result, the exact number of long COVID disability claims and the number of these cases going to court isn’t clear, he said.

“It can take a year or more for cases to get to court, and even longer to reach resolution,” Mr. LaPorte added. “I suspect the few cases we’ve heard about at this point are going to be the tip of the iceberg.”

The process is convoluted and can drag on for months with multiple denials and appeals along the way. Many disabled workers find their only recourse is to take insurers to court.

Long COVID patients typically apply for disability benefits through private insurance or Social Security. But the process can drag on for months, so many find their only recourse is to take insurers to court, according to legal experts.

But even in the courts, many encounter delays and hurdles to resolution.

In one of the first federal lawsuits involving long COVID disability benefits, William Abrams, a trial and appellate attorney and active marathon runner, sued Unum Life Insurance seeking long-term disability income. Symptoms included extreme fatigue, brain fog, decreased attention and concentration, and nearly daily fevers, causing him to stop working in April 2020.

His diagnosis wasn’t definitive. Three doctors said he had long COVID, and four said he had chronic fatigue syndrome. Unum cited this inconsistency as a rationale for rejecting his claim. But the court sided with Mr. Abrams, granting him disability income. The court concluded: “Unum may be correct that [the plaintiff] has not been correctly diagnosed. But that does not mean he is not sick. If [the plaintiff’s] complaints, and [the doctor’s] assessments, are to be believed, [the plaintiff] cannot focus for more than a few minutes at a time, making it impossible for [the plaintiff] to perform the varied and complex tasks his job requires.”

Unum said in an emailed statement that the company doesn’t comment on specific claims as a matter of policy, adding that its total payouts for disability claims from March 2020 to February 2022 were 35% higher than prepandemic levels. “In general, disability and leave claims connected to COVID-19 have been primarily short-term events with the majority of claimants recovering prior to completing the normal qualification period for long-term disability insurance,” Unum said.

Mr. Abrams prevailed in part because he had detailed documentation of the numerous impairments that eventually required him to stop work, said Michelle Roberts of Roberts Disability Law in Oakland, Calif.

He submitted videos of himself taking his temperature to prove he had almost daily fevers, according to court records. He underwent neuropsychological testing, which found learning deficiencies and memory deficits.

Mr. Abrams also submitted statements from a colleague who worked with him on a complex technology patent case involving radiofrequency identification. Before he got COVID, Mr. Abrams “had the analytical ability, legal acumen, and mental energy to attack that learning curve and get up to speed very rapidly,” according to court records.

“The court focused on credulity.” Ms. Roberts said. “There was all this work to be done to show this person was high functioning and ran marathons and worked in an intense, high-pressure occupation but then couldn’t do anything after long COVID.”

Documentation was also crucial in another early federal long COVID disability lawsuit that was filed in 2022 on behalf of Wendy Haut, an educational software sales representative in California who turned to the courts seeking disability income through her company’s employee benefits plan.

Several of Ms. Haut’s doctors documented a detailed list of long COVID symptoms, including “profound fatigue and extreme cognitive difficulties,” that they said prevented her from working as a sales representative or doing any other type of job. A settlement agreement in June 2022 required Reliance Standard Life Insurance to pay Ms. Haut long-term disability benefits, including previously unpaid benefits, according to a report by the advocacy group Pandemic Patients.

Representatives of Reliance Standard didn’t respond to a request for comment.

The growing number of workers being sidelined by long COVID makes more claims and more court cases likely. Right now, an estimated 16 million working-age Americans aged 18-65 years have long COVID, and as many as 4 million of them can’t work, according to a July 2023 Census Bureau report.

Uncertainty about the volume of claims in the pipeline is part of what’s driving some insurers to fight long COVID claims, Ms. Roberts said. Another factor is the lack of clarity around how many years people with long COVID may be out of work, particularly if they’re in their 30s or 40s and might be seeking disability income until they reach retirement age.

“Doctors are not always saying that this person will be permanently disabled,” Ms. Roberts said. “If this person doesn’t get better and they’re disabled until retirement age, this could be a payout in the high six or seven figures if a person is very young and was a very high earner.”

Insurance companies routinely deny claims that can’t be backed up with objective measures, such as specific lab test results or clear findings from a physical exam. But there are steps that can increase the odds of a successful claim for long COVID disability benefits, according to New York–based law firm Hiller.

For starters, patients can document COVID test results, and if testing wasn’t conducted, patients can detail the specific symptoms that led to this diagnosis, Hiller advises. Then patients can keep a daily symptom log at home that run lists all of the specific symptoms that occur at different times during the day and night to help establish a pattern of disability. These logs should provide specific details about every job duty patients have and exactly how specific symptoms of long COVID interfere with these duties.

Even though objective testing is hard to come by for long COVID, people should undergo all the tests they can that may help document the frequency or severity of specific symptoms that make it impossible to carry on with business as usual at work, Hiller advises. This may include neuropsychological testing to document brain fog, a cardiopulmonary exercise test to demonstrate chronic fatigue and the inability to exercise, or a tilt table test to measure dizziness.

Seeking a doctor’s diagnosis can be key to collecting disability payments, in or out of court.

All of this puts a lot of pressure on doctors and patients to build strong cases, said Jonathan Whiteson, MD, codirector of the NYU Langone Health post-COVID care program in New York. “Many physicians are not familiar with the disability benefit paperwork, and so this is a challenge for the doctors to know how to complete and to build the time into their highly scheduled days to take the time needed to complete.

“It’s also challenging because most of the disability benefit forms are ‘generic’ and do not ask specific questions about COVID disability,” Dr. Whiteson added. “It can be like trying to drive a square peg into a round hole.”

Still, when it comes to long COVID, completing disability paperwork is increasingly becoming part of standard care, along with managing medication, rehabilitation therapies, and lifestyle changes to navigate daily life with this illness, Dr. Whiteson noted.

Monica Verduzco-Gutierrez, MD, chair of rehabilitation medicine and director of the Post-COVID-19 Recovery Clinic at the University of Texas Health Science Center, San Antonio, agreed with this assessment.

“I have done letter upon letter of appeal to disability insurance companies,” she said.

Some doctors, however, are reluctant to step up in such cases, in part because no standard diagnostic guidelines exist for long COVID and because it can be frustrating.

“This is the work that is not paid and causes burnout in physicians,” Dr. Verduzco-Gutierrez said. “The paperwork, the fighting with insurance companies, the resubmission of forms for disability all to get what your patient needs – and then it gets denied.

“We will keep doing this because our patients need this disability income in order to live their lives and to afford what they need for recovery,” said Dr. Verduzco-Gutierrez. “But at some point something has to change because this isn’t sustainable.”

A version of this article appeared on Medscape.com.

A popular ingredient in the American diet has been linked to ulcerative colitis. The ingredient is soybean oil, which is very common in processed foods. In fact, U.S. per capita consumption of soybean oil increased more than 1,000-fold during the 20th century.

In a study from the University of California, Riverside, and UC Davis, published in Gut Microbes, mice fed a diet high in soybean oil were more at risk of developing colitis. 

The likely culprit? Linoleic acid, an omega-6 fatty acid that composes up to 60% of soybean oil.

Small amounts of linoleic acid help maintain the body’s water balance. But Americans derive as much as 10% of their daily energy from linoleic acid, when they need only 1%-2%, the researchers say.

The findings build on earlier research linking a high-linoleic acid diet with inflammatory bowel disease, or IBD, in humans. (Previous research in mice has also linked high consumption of the oil with obesity and diabetes in the rodents.)

For the new study, the researchers wanted to drill down into how linoleic acid affects the gut.
 

How linoleic acid may promote inflammation

In mice, the soybean oil diet upset the ratio of omega-3 to omega-6 fatty acids in the gut. This led to a decrease in endocannabinoids, lipid-based molecules that help block inflammation.

Enzymes that metabolize fatty acids are “shared between two pathways,” said study coauthor Frances Sladek, PhD, professor of cell biology at UC Riverside. “If you swamp the system with linoleic acid, you’ll have less enzymes available to metabolize omega-3s into good endocannabinoids.”

The endocannabinoid system has been linked to “visceral pain” in the gut,  said Punyanganie de Silva, MD, MPH, an assistant professor at Brigham & Women’s Hospital, Boston, who was not involved in the study. But the relationship between the endocannabinoid system and inflammation has yet to be fully explored.

“This is one of the first papers that has looked at the association between linoleic acid and the endocannabinoid system,” Dr. de Silva said. “[The researchers] propose a potential new mechanism of how linoleic acid may increase inflammation” – that is, through its impact on the endocannabinoid system. 
 

Changes in the gut microbiome

The gut microbiome of the mice also showed increased amounts of adherent invasive E. coli, a type of bacteria that grows by using linoleic acid as a carbon source. A “very close relative” of this bacteria has been linked to IBD in humans, Dr. Sladek said.

Using a method known as metabolomics, the researchers studied 3,000 metabolites in the intestinal cells of both the mice and the bacteria. Endocannabinoids decreased in both.

“We were actually quite surprised. I didn’t realize that bacteria made endocannabinoids,” Dr. Sladek said.

Helpful bacteria, such as the probiotic lactobacillus species, died off. The mice also had increased levels of oxylipins, which are correlated with obesity in mice and colitis in humans.
 

A high–linoleic acid diet could mean a leaky gut

Linoleic acid binds to a protein known as HNF-4 alpha. Disrupting the expression of this protein can weaken the intestinal barrier, letting toxins flow into the body – more commonly known as leaky gut. Mice on the soybean oil diet had decreased levels of the protein and more porous intestinal barriers, raising the risk for inflammation and colitis. “The HNF-4 alpha protein is conserved from mouse to human, so whatever’s happening to it in the context of the mouse gut, there’s a very high chance that a similar effect could be seen in humans as well,” said study coauthor Poonamjot Deol, PhD, an assistant professional researcher at UC Riverside.

Still, Dr. de Silva urges “some caution when interpreting these results,” given that “this is still experimental and needs to be reproduced in clinical studies as humans have a far more varied microbiome and more variable environmental exposures than these very controlled mouse model studies.”

Dr. de Silva says cooking with olive oil can “help increase omega-3 to omega-6 ratios” and advises eating a varied diet that includes omega-3 fats, such as flaxseed and walnuts, and minimal amounts of processed foods and saturated fats.

Looking ahead, endocannabinoids are being explored as “a potential therapy for treating IBD symptoms,” said Dr. Deol. She hopes to delve further into how linoleic acid affects the endocannabinoid system.

A version of this article first appeared on WebMD.com.

A popular ingredient in the American diet has been linked to ulcerative colitis. The ingredient is soybean oil, which is very common in processed foods. In fact, U.S. per capita consumption of soybean oil increased more than 1,000-fold during the 20th century.

In a study from the University of California, Riverside, and UC Davis, published in Gut Microbes, mice fed a diet high in soybean oil were more at risk of developing colitis. 

The likely culprit? Linoleic acid, an omega-6 fatty acid that composes up to 60% of soybean oil.

Small amounts of linoleic acid help maintain the body’s water balance. But Americans derive as much as 10% of their daily energy from linoleic acid, when they need only 1%-2%, the researchers say.

The findings build on earlier research linking a high-linoleic acid diet with inflammatory bowel disease, or IBD, in humans. (Previous research in mice has also linked high consumption of the oil with obesity and diabetes in the rodents.)

For the new study, the researchers wanted to drill down into how linoleic acid affects the gut.
 

How linoleic acid may promote inflammation

In mice, the soybean oil diet upset the ratio of omega-3 to omega-6 fatty acids in the gut. This led to a decrease in endocannabinoids, lipid-based molecules that help block inflammation.

Enzymes that metabolize fatty acids are “shared between two pathways,” said study coauthor Frances Sladek, PhD, professor of cell biology at UC Riverside. “If you swamp the system with linoleic acid, you’ll have less enzymes available to metabolize omega-3s into good endocannabinoids.”

The endocannabinoid system has been linked to “visceral pain” in the gut,  said Punyanganie de Silva, MD, MPH, an assistant professor at Brigham & Women’s Hospital, Boston, who was not involved in the study. But the relationship between the endocannabinoid system and inflammation has yet to be fully explored.

“This is one of the first papers that has looked at the association between linoleic acid and the endocannabinoid system,” Dr. de Silva said. “[The researchers] propose a potential new mechanism of how linoleic acid may increase inflammation” – that is, through its impact on the endocannabinoid system. 
 

Changes in the gut microbiome

The gut microbiome of the mice also showed increased amounts of adherent invasive E. coli, a type of bacteria that grows by using linoleic acid as a carbon source. A “very close relative” of this bacteria has been linked to IBD in humans, Dr. Sladek said.

Using a method known as metabolomics, the researchers studied 3,000 metabolites in the intestinal cells of both the mice and the bacteria. Endocannabinoids decreased in both.

“We were actually quite surprised. I didn’t realize that bacteria made endocannabinoids,” Dr. Sladek said.

Helpful bacteria, such as the probiotic lactobacillus species, died off. The mice also had increased levels of oxylipins, which are correlated with obesity in mice and colitis in humans.
 

A high–linoleic acid diet could mean a leaky gut

Linoleic acid binds to a protein known as HNF-4 alpha. Disrupting the expression of this protein can weaken the intestinal barrier, letting toxins flow into the body – more commonly known as leaky gut. Mice on the soybean oil diet had decreased levels of the protein and more porous intestinal barriers, raising the risk for inflammation and colitis. “The HNF-4 alpha protein is conserved from mouse to human, so whatever’s happening to it in the context of the mouse gut, there’s a very high chance that a similar effect could be seen in humans as well,” said study coauthor Poonamjot Deol, PhD, an assistant professional researcher at UC Riverside.

Still, Dr. de Silva urges “some caution when interpreting these results,” given that “this is still experimental and needs to be reproduced in clinical studies as humans have a far more varied microbiome and more variable environmental exposures than these very controlled mouse model studies.”

Dr. de Silva says cooking with olive oil can “help increase omega-3 to omega-6 ratios” and advises eating a varied diet that includes omega-3 fats, such as flaxseed and walnuts, and minimal amounts of processed foods and saturated fats.

Looking ahead, endocannabinoids are being explored as “a potential therapy for treating IBD symptoms,” said Dr. Deol. She hopes to delve further into how linoleic acid affects the endocannabinoid system.

A version of this article first appeared on WebMD.com.

A popular ingredient in the American diet has been linked to ulcerative colitis. The ingredient is soybean oil, which is very common in processed foods. In fact, U.S. per capita consumption of soybean oil increased more than 1,000-fold during the 20th century.

In a study from the University of California, Riverside, and UC Davis, published in Gut Microbes, mice fed a diet high in soybean oil were more at risk of developing colitis. 

The likely culprit? Linoleic acid, an omega-6 fatty acid that composes up to 60% of soybean oil.

Small amounts of linoleic acid help maintain the body’s water balance. But Americans derive as much as 10% of their daily energy from linoleic acid, when they need only 1%-2%, the researchers say.

The findings build on earlier research linking a high-linoleic acid diet with inflammatory bowel disease, or IBD, in humans. (Previous research in mice has also linked high consumption of the oil with obesity and diabetes in the rodents.)

For the new study, the researchers wanted to drill down into how linoleic acid affects the gut.
 

How linoleic acid may promote inflammation

In mice, the soybean oil diet upset the ratio of omega-3 to omega-6 fatty acids in the gut. This led to a decrease in endocannabinoids, lipid-based molecules that help block inflammation.

Enzymes that metabolize fatty acids are “shared between two pathways,” said study coauthor Frances Sladek, PhD, professor of cell biology at UC Riverside. “If you swamp the system with linoleic acid, you’ll have less enzymes available to metabolize omega-3s into good endocannabinoids.”

The endocannabinoid system has been linked to “visceral pain” in the gut,  said Punyanganie de Silva, MD, MPH, an assistant professor at Brigham & Women’s Hospital, Boston, who was not involved in the study. But the relationship between the endocannabinoid system and inflammation has yet to be fully explored.

“This is one of the first papers that has looked at the association between linoleic acid and the endocannabinoid system,” Dr. de Silva said. “[The researchers] propose a potential new mechanism of how linoleic acid may increase inflammation” – that is, through its impact on the endocannabinoid system. 
 

Changes in the gut microbiome

The gut microbiome of the mice also showed increased amounts of adherent invasive E. coli, a type of bacteria that grows by using linoleic acid as a carbon source. A “very close relative” of this bacteria has been linked to IBD in humans, Dr. Sladek said.

Using a method known as metabolomics, the researchers studied 3,000 metabolites in the intestinal cells of both the mice and the bacteria. Endocannabinoids decreased in both.

“We were actually quite surprised. I didn’t realize that bacteria made endocannabinoids,” Dr. Sladek said.

Helpful bacteria, such as the probiotic lactobacillus species, died off. The mice also had increased levels of oxylipins, which are correlated with obesity in mice and colitis in humans.
 

A high–linoleic acid diet could mean a leaky gut

Linoleic acid binds to a protein known as HNF-4 alpha. Disrupting the expression of this protein can weaken the intestinal barrier, letting toxins flow into the body – more commonly known as leaky gut. Mice on the soybean oil diet had decreased levels of the protein and more porous intestinal barriers, raising the risk for inflammation and colitis. “The HNF-4 alpha protein is conserved from mouse to human, so whatever’s happening to it in the context of the mouse gut, there’s a very high chance that a similar effect could be seen in humans as well,” said study coauthor Poonamjot Deol, PhD, an assistant professional researcher at UC Riverside.

Still, Dr. de Silva urges “some caution when interpreting these results,” given that “this is still experimental and needs to be reproduced in clinical studies as humans have a far more varied microbiome and more variable environmental exposures than these very controlled mouse model studies.”

Dr. de Silva says cooking with olive oil can “help increase omega-3 to omega-6 ratios” and advises eating a varied diet that includes omega-3 fats, such as flaxseed and walnuts, and minimal amounts of processed foods and saturated fats.

Looking ahead, endocannabinoids are being explored as “a potential therapy for treating IBD symptoms,” said Dr. Deol. She hopes to delve further into how linoleic acid affects the endocannabinoid system.

A version of this article first appeared on WebMD.com.

BALTIMORE – Receiving the first dose of the human papillomavirus (HPV) vaccine at age 9, rather than bundling it with the Tdap and meningitis vaccines, appears to increase the likelihood that children will complete the HPV vaccine series, according to a retrospective cohort study of commercially insured youth presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. The research was published ahead of print in Human Vaccines and Immunotherapeutics.

Changing attitudes

“These findings are novel because they emphasize starting at age 9, and that is different than prior studies that emphasize bundling of these vaccines,” Kevin Ault, MD, professor and chair of the department of obstetrics and gynecology at Western Michigan University Homer Stryker MD School of Medicine and a former member of the CDC’s Advisory Committee on Immunization Practices, said in an interview.

Dr. Ault was not involved in the study but noted that these findings support the AAP’s recommendation to start the HPV vaccine series at age 9. The Centers for Disease Control and Prevention currently recommends giving the first dose of the HPV vaccine at ages 11-12, at the same time as the Tdap and meningitis vaccines. This recommendation to “bundle” the HPV vaccine with the Tdap and meningitis vaccines aims to facilitate provider-family discussion about the HPV vaccine, ideally reducing parent hesitancy and concerns about the vaccines. Multiple studies have shown improved HPV vaccine uptake when providers offer the HPV vaccine at the same time as the Tdap and meningococcal vaccines.

However, shifts in parents’ attitudes have occurred toward the HPV vaccine since those studies on bundling: Concerns about sexual activity have receded while concerns about safety remain high. The American Academy of Pediatrics and the American Cancer Society both advise starting the HPV vaccine series at age 9, based on evidence showing that more children complete the series when they get the first shot before age 11 compared to getting it at 11 or 12.

“The bundling was really to vaccinate people by the age of 13, thinking that onset of sexual activity was after that,” study author Sidika Kajtezovic, MD, a resident at Boston Medical Center and Boston University Obstetrics and Gynecology, said in an interview. But Dr. Kajtezovic said she delivers babies for 13-year-old patients. “Kids are having sex sooner or sooner.” It’s also clear that using the bundling strategy is not making up the entire gap right now: Ninety percent of children are getting the meningococcal vaccine while only 49% are getting the HPV vaccine, Dr. Kajtezovic pointed out. “There’s a disconnect happening there, even with the bundling,” she said.
 

Debundling vaccines

Dr. Kajtezovic and her colleagues used a national database of employee-sponsored health insurance to analyze the records of 100,857 children who were continuously enrolled in a plan from age 9 in 2015 to age 13 in 2019. They calculated the odds of children completing the HPV vaccine series based on whether they started the series before, at the same time as, or after the Tdap vaccination.

Youth who received the HPV vaccine before their Tdap vaccine had 38% greater odds of completing the series – getting both doses – than did those who received the HPV vaccine at the same time as the Tdap vaccine. Meanwhile, in line with prior evidence, those who got the first HPV dose after their Tdap were less likely – 68% lower odds – to complete the two- or three-dose (if starting above age 14) series.

The researchers identified several other factors that were linked to completing the HPV vaccine series. Females had greater odds than did males of completing the series, as did those living in urban, rather than rural, areas. Other factors associated with completing the series included living in the Northeast United States and receiving primary care from a pediatrician rather than a family medicine physician.
 

Timing is important

“I am encouraged by the findings of this study,” Dr. Ault said in an interview. “However, I would have liked the authors to expand the age range a bit higher. There are data that continuing to discuss the HPV vaccine with parents and teens will increase uptake into the later teen years.”

One challenge is that research shows attendance at primary care visits declines in older adolescence. Since there is no second Tdap or meningitis shot, families need to return for the second HPV vaccine dose after those shots, though they could get the second dose at the same time as other two vaccines if they receive the first dose before age 11. There’s also evidence suggesting that providers find conversations about the HPV vaccine easier when sexual activity is not the focus.

“I often feel that, before a child reaches adolescence, they’re almost, in a way, not sexualized yet, so talking about cancer prevention for an 8- or 9-year-old sometimes sounds a little different to patients versus protecting your 12-year-old, who’s starting to go through adolescence and developing breasts” and other signs of puberty, Dr. Kajtezovic said. Keeping the focus of HPV vaccine discussions on cancer prevention also allows providers to point out the protection against anal cancer, vulvar cancer, vaginal cancer, and head and neck cancer. “They are horrible, and even if they’re treatable, they’re often very hard to treat at an advanced stage,” Dr. Kajtezovic said. “The surgery required is so life disabling and disfiguring.”

The HPV Roundtable advises continuing bundling at practices having success with it but encourages practices to consider earlier vaccination if their uptake is lagging. Quality improvement initiatives, such as earlier electronic medical record prompts and multi-level interventions in pediatric practices, have shown substantial increases in HPV vaccine uptake at 9 and 10 years old. One survey in 2021 found that one in five primary care providers already routinely recommend the HPV vaccine at ages 9-10, and nearly half of others would consider doing so.

“My hope is in the next few years, when [the CDC] refreshes their vaccine recommendations, that they will either unbundle it or move the bar a few years earlier so that you can initiate it to encourage earlier initiation,” Dr. Kajtezovic said.

Dr. Ault had no other disclosures besides prior service on ACIP. Dr. Kajtezovic had no disclosures.

BALTIMORE – Receiving the first dose of the human papillomavirus (HPV) vaccine at age 9, rather than bundling it with the Tdap and meningitis vaccines, appears to increase the likelihood that children will complete the HPV vaccine series, according to a retrospective cohort study of commercially insured youth presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. The research was published ahead of print in Human Vaccines and Immunotherapeutics.

Changing attitudes

“These findings are novel because they emphasize starting at age 9, and that is different than prior studies that emphasize bundling of these vaccines,” Kevin Ault, MD, professor and chair of the department of obstetrics and gynecology at Western Michigan University Homer Stryker MD School of Medicine and a former member of the CDC’s Advisory Committee on Immunization Practices, said in an interview.

Dr. Ault was not involved in the study but noted that these findings support the AAP’s recommendation to start the HPV vaccine series at age 9. The Centers for Disease Control and Prevention currently recommends giving the first dose of the HPV vaccine at ages 11-12, at the same time as the Tdap and meningitis vaccines. This recommendation to “bundle” the HPV vaccine with the Tdap and meningitis vaccines aims to facilitate provider-family discussion about the HPV vaccine, ideally reducing parent hesitancy and concerns about the vaccines. Multiple studies have shown improved HPV vaccine uptake when providers offer the HPV vaccine at the same time as the Tdap and meningococcal vaccines.

However, shifts in parents’ attitudes have occurred toward the HPV vaccine since those studies on bundling: Concerns about sexual activity have receded while concerns about safety remain high. The American Academy of Pediatrics and the American Cancer Society both advise starting the HPV vaccine series at age 9, based on evidence showing that more children complete the series when they get the first shot before age 11 compared to getting it at 11 or 12.

“The bundling was really to vaccinate people by the age of 13, thinking that onset of sexual activity was after that,” study author Sidika Kajtezovic, MD, a resident at Boston Medical Center and Boston University Obstetrics and Gynecology, said in an interview. But Dr. Kajtezovic said she delivers babies for 13-year-old patients. “Kids are having sex sooner or sooner.” It’s also clear that using the bundling strategy is not making up the entire gap right now: Ninety percent of children are getting the meningococcal vaccine while only 49% are getting the HPV vaccine, Dr. Kajtezovic pointed out. “There’s a disconnect happening there, even with the bundling,” she said.
 

Debundling vaccines

Dr. Kajtezovic and her colleagues used a national database of employee-sponsored health insurance to analyze the records of 100,857 children who were continuously enrolled in a plan from age 9 in 2015 to age 13 in 2019. They calculated the odds of children completing the HPV vaccine series based on whether they started the series before, at the same time as, or after the Tdap vaccination.

Youth who received the HPV vaccine before their Tdap vaccine had 38% greater odds of completing the series – getting both doses – than did those who received the HPV vaccine at the same time as the Tdap vaccine. Meanwhile, in line with prior evidence, those who got the first HPV dose after their Tdap were less likely – 68% lower odds – to complete the two- or three-dose (if starting above age 14) series.

The researchers identified several other factors that were linked to completing the HPV vaccine series. Females had greater odds than did males of completing the series, as did those living in urban, rather than rural, areas. Other factors associated with completing the series included living in the Northeast United States and receiving primary care from a pediatrician rather than a family medicine physician.
 

Timing is important

“I am encouraged by the findings of this study,” Dr. Ault said in an interview. “However, I would have liked the authors to expand the age range a bit higher. There are data that continuing to discuss the HPV vaccine with parents and teens will increase uptake into the later teen years.”

One challenge is that research shows attendance at primary care visits declines in older adolescence. Since there is no second Tdap or meningitis shot, families need to return for the second HPV vaccine dose after those shots, though they could get the second dose at the same time as other two vaccines if they receive the first dose before age 11. There’s also evidence suggesting that providers find conversations about the HPV vaccine easier when sexual activity is not the focus.

“I often feel that, before a child reaches adolescence, they’re almost, in a way, not sexualized yet, so talking about cancer prevention for an 8- or 9-year-old sometimes sounds a little different to patients versus protecting your 12-year-old, who’s starting to go through adolescence and developing breasts” and other signs of puberty, Dr. Kajtezovic said. Keeping the focus of HPV vaccine discussions on cancer prevention also allows providers to point out the protection against anal cancer, vulvar cancer, vaginal cancer, and head and neck cancer. “They are horrible, and even if they’re treatable, they’re often very hard to treat at an advanced stage,” Dr. Kajtezovic said. “The surgery required is so life disabling and disfiguring.”

The HPV Roundtable advises continuing bundling at practices having success with it but encourages practices to consider earlier vaccination if their uptake is lagging. Quality improvement initiatives, such as earlier electronic medical record prompts and multi-level interventions in pediatric practices, have shown substantial increases in HPV vaccine uptake at 9 and 10 years old. One survey in 2021 found that one in five primary care providers already routinely recommend the HPV vaccine at ages 9-10, and nearly half of others would consider doing so.

“My hope is in the next few years, when [the CDC] refreshes their vaccine recommendations, that they will either unbundle it or move the bar a few years earlier so that you can initiate it to encourage earlier initiation,” Dr. Kajtezovic said.

Dr. Ault had no other disclosures besides prior service on ACIP. Dr. Kajtezovic had no disclosures.

BALTIMORE – Receiving the first dose of the human papillomavirus (HPV) vaccine at age 9, rather than bundling it with the Tdap and meningitis vaccines, appears to increase the likelihood that children will complete the HPV vaccine series, according to a retrospective cohort study of commercially insured youth presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. The research was published ahead of print in Human Vaccines and Immunotherapeutics.

Changing attitudes

“These findings are novel because they emphasize starting at age 9, and that is different than prior studies that emphasize bundling of these vaccines,” Kevin Ault, MD, professor and chair of the department of obstetrics and gynecology at Western Michigan University Homer Stryker MD School of Medicine and a former member of the CDC’s Advisory Committee on Immunization Practices, said in an interview.

Dr. Ault was not involved in the study but noted that these findings support the AAP’s recommendation to start the HPV vaccine series at age 9. The Centers for Disease Control and Prevention currently recommends giving the first dose of the HPV vaccine at ages 11-12, at the same time as the Tdap and meningitis vaccines. This recommendation to “bundle” the HPV vaccine with the Tdap and meningitis vaccines aims to facilitate provider-family discussion about the HPV vaccine, ideally reducing parent hesitancy and concerns about the vaccines. Multiple studies have shown improved HPV vaccine uptake when providers offer the HPV vaccine at the same time as the Tdap and meningococcal vaccines.

However, shifts in parents’ attitudes have occurred toward the HPV vaccine since those studies on bundling: Concerns about sexual activity have receded while concerns about safety remain high. The American Academy of Pediatrics and the American Cancer Society both advise starting the HPV vaccine series at age 9, based on evidence showing that more children complete the series when they get the first shot before age 11 compared to getting it at 11 or 12.

“The bundling was really to vaccinate people by the age of 13, thinking that onset of sexual activity was after that,” study author Sidika Kajtezovic, MD, a resident at Boston Medical Center and Boston University Obstetrics and Gynecology, said in an interview. But Dr. Kajtezovic said she delivers babies for 13-year-old patients. “Kids are having sex sooner or sooner.” It’s also clear that using the bundling strategy is not making up the entire gap right now: Ninety percent of children are getting the meningococcal vaccine while only 49% are getting the HPV vaccine, Dr. Kajtezovic pointed out. “There’s a disconnect happening there, even with the bundling,” she said.
 

Debundling vaccines

Dr. Kajtezovic and her colleagues used a national database of employee-sponsored health insurance to analyze the records of 100,857 children who were continuously enrolled in a plan from age 9 in 2015 to age 13 in 2019. They calculated the odds of children completing the HPV vaccine series based on whether they started the series before, at the same time as, or after the Tdap vaccination.

Youth who received the HPV vaccine before their Tdap vaccine had 38% greater odds of completing the series – getting both doses – than did those who received the HPV vaccine at the same time as the Tdap vaccine. Meanwhile, in line with prior evidence, those who got the first HPV dose after their Tdap were less likely – 68% lower odds – to complete the two- or three-dose (if starting above age 14) series.

The researchers identified several other factors that were linked to completing the HPV vaccine series. Females had greater odds than did males of completing the series, as did those living in urban, rather than rural, areas. Other factors associated with completing the series included living in the Northeast United States and receiving primary care from a pediatrician rather than a family medicine physician.
 

Timing is important

“I am encouraged by the findings of this study,” Dr. Ault said in an interview. “However, I would have liked the authors to expand the age range a bit higher. There are data that continuing to discuss the HPV vaccine with parents and teens will increase uptake into the later teen years.”

One challenge is that research shows attendance at primary care visits declines in older adolescence. Since there is no second Tdap or meningitis shot, families need to return for the second HPV vaccine dose after those shots, though they could get the second dose at the same time as other two vaccines if they receive the first dose before age 11. There’s also evidence suggesting that providers find conversations about the HPV vaccine easier when sexual activity is not the focus.

“I often feel that, before a child reaches adolescence, they’re almost, in a way, not sexualized yet, so talking about cancer prevention for an 8- or 9-year-old sometimes sounds a little different to patients versus protecting your 12-year-old, who’s starting to go through adolescence and developing breasts” and other signs of puberty, Dr. Kajtezovic said. Keeping the focus of HPV vaccine discussions on cancer prevention also allows providers to point out the protection against anal cancer, vulvar cancer, vaginal cancer, and head and neck cancer. “They are horrible, and even if they’re treatable, they’re often very hard to treat at an advanced stage,” Dr. Kajtezovic said. “The surgery required is so life disabling and disfiguring.”

The HPV Roundtable advises continuing bundling at practices having success with it but encourages practices to consider earlier vaccination if their uptake is lagging. Quality improvement initiatives, such as earlier electronic medical record prompts and multi-level interventions in pediatric practices, have shown substantial increases in HPV vaccine uptake at 9 and 10 years old. One survey in 2021 found that one in five primary care providers already routinely recommend the HPV vaccine at ages 9-10, and nearly half of others would consider doing so.

“My hope is in the next few years, when [the CDC] refreshes their vaccine recommendations, that they will either unbundle it or move the bar a few years earlier so that you can initiate it to encourage earlier initiation,” Dr. Kajtezovic said.

Dr. Ault had no other disclosures besides prior service on ACIP. Dr. Kajtezovic had no disclosures.

Practice Gap

Wound dressings protect the skin and prevent contamination. The hair often makes it difficult to affix a dressing after a minor scalp trauma or local surgery on the head. Traditional approaches for fastening a dressing on the head include bandage winding or adhesive tape, but these methods often affect aesthetics or cause discomfort—bandage winding can make it inconvenient for the patient to move their head, and adhesive tape can cause pain by pulling the hair during removal.

To better position a scalp dressing, tie-over dressings, braid dressings, and paper clips have been used as fixators.^1-3 These methods have benefits and disadvantages.

Tie-over Dressing—The dressing is clasped with long sutures that were reserved during wound closure. This method is sturdy, can slightly compress the wound, and is applicable to any part of the scalp. However, it requires more sutures, and more careful wound care may be required due to the edge of the dressing being close to the wound.

Braid Dressing—Tape, a rubber band, or braided hair is used to bind the gauze pad. This dressing is simple and inexpensive. However, it is limited to patients with long hair; even then, it often is difficult to anchor the dressing by braiding hair. Moreover, removal of the rubber band and tape can cause discomfort or pain.

Paper Clip—This is a simple scalp dressing fixator. However, due to the short and circular structure of the clip, it is not conducive to affixing a gauze dressing for patients with short hair, and it often hooks the gauze and hair, making it inconvenient for the physician and a source of discomfort for the patient when the paper clip is being removed.

The Technique

To address shortcomings of traditional methods, we encourage the use of hairpins to affix a dressing after a scalp wound is sutured. Two steps are required:

• Position the gauze to cover the wound and press the gauze down with your hand.
• Clamp the 4 corners of the dressing and adjacent hair with hairpins (Figure, A).

Practical Implications

Hairpins are common for fixing hairstyles and decorating hair. They are inexpensive, easy to obtain, simple in structure, convenient to use without additional discomfort, and easy to remove (Figure, B). Because most hairpins have a powerful clamping force, they can affix dressings in short hair (Figure, A). All medical staff can use hairpins to anchor the scalp dressing. Even a patient’s family members can carry out simple dressing replacement and wound cleaning using this method. Patients also have many options for hairpin styles, which is especially useful in easing the apprehension of surgery in pediatric patients.

Practice Gap

Wound dressings protect the skin and prevent contamination. The hair often makes it difficult to affix a dressing after a minor scalp trauma or local surgery on the head. Traditional approaches for fastening a dressing on the head include bandage winding or adhesive tape, but these methods often affect aesthetics or cause discomfort—bandage winding can make it inconvenient for the patient to move their head, and adhesive tape can cause pain by pulling the hair during removal.

To better position a scalp dressing, tie-over dressings, braid dressings, and paper clips have been used as fixators.^1-3 These methods have benefits and disadvantages.

Tie-over Dressing—The dressing is clasped with long sutures that were reserved during wound closure. This method is sturdy, can slightly compress the wound, and is applicable to any part of the scalp. However, it requires more sutures, and more careful wound care may be required due to the edge of the dressing being close to the wound.

Braid Dressing—Tape, a rubber band, or braided hair is used to bind the gauze pad. This dressing is simple and inexpensive. However, it is limited to patients with long hair; even then, it often is difficult to anchor the dressing by braiding hair. Moreover, removal of the rubber band and tape can cause discomfort or pain.

Paper Clip—This is a simple scalp dressing fixator. However, due to the short and circular structure of the clip, it is not conducive to affixing a gauze dressing for patients with short hair, and it often hooks the gauze and hair, making it inconvenient for the physician and a source of discomfort for the patient when the paper clip is being removed.

The Technique

To address shortcomings of traditional methods, we encourage the use of hairpins to affix a dressing after a scalp wound is sutured. Two steps are required:

• Position the gauze to cover the wound and press the gauze down with your hand.
• Clamp the 4 corners of the dressing and adjacent hair with hairpins (Figure, A).

Practical Implications

Hairpins are common for fixing hairstyles and decorating hair. They are inexpensive, easy to obtain, simple in structure, convenient to use without additional discomfort, and easy to remove (Figure, B). Because most hairpins have a powerful clamping force, they can affix dressings in short hair (Figure, A). All medical staff can use hairpins to anchor the scalp dressing. Even a patient’s family members can carry out simple dressing replacement and wound cleaning using this method. Patients also have many options for hairpin styles, which is especially useful in easing the apprehension of surgery in pediatric patients.

Practice Gap

Wound dressings protect the skin and prevent contamination. The hair often makes it difficult to affix a dressing after a minor scalp trauma or local surgery on the head. Traditional approaches for fastening a dressing on the head include bandage winding or adhesive tape, but these methods often affect aesthetics or cause discomfort—bandage winding can make it inconvenient for the patient to move their head, and adhesive tape can cause pain by pulling the hair during removal.

To better position a scalp dressing, tie-over dressings, braid dressings, and paper clips have been used as fixators.^1-3 These methods have benefits and disadvantages.

Tie-over Dressing—The dressing is clasped with long sutures that were reserved during wound closure. This method is sturdy, can slightly compress the wound, and is applicable to any part of the scalp. However, it requires more sutures, and more careful wound care may be required due to the edge of the dressing being close to the wound.

Braid Dressing—Tape, a rubber band, or braided hair is used to bind the gauze pad. This dressing is simple and inexpensive. However, it is limited to patients with long hair; even then, it often is difficult to anchor the dressing by braiding hair. Moreover, removal of the rubber band and tape can cause discomfort or pain.

Paper Clip—This is a simple scalp dressing fixator. However, due to the short and circular structure of the clip, it is not conducive to affixing a gauze dressing for patients with short hair, and it often hooks the gauze and hair, making it inconvenient for the physician and a source of discomfort for the patient when the paper clip is being removed.

The Technique

To address shortcomings of traditional methods, we encourage the use of hairpins to affix a dressing after a scalp wound is sutured. Two steps are required:

• Position the gauze to cover the wound and press the gauze down with your hand.
• Clamp the 4 corners of the dressing and adjacent hair with hairpins (Figure, A).

Practical Implications

Hairpins are common for fixing hairstyles and decorating hair. They are inexpensive, easy to obtain, simple in structure, convenient to use without additional discomfort, and easy to remove (Figure, B). Because most hairpins have a powerful clamping force, they can affix dressings in short hair (Figure, A). All medical staff can use hairpins to anchor the scalp dressing. Even a patient’s family members can carry out simple dressing replacement and wound cleaning using this method. Patients also have many options for hairpin styles, which is especially useful in easing the apprehension of surgery in pediatric patients.