CHEST Physician

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.

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.

Outsourcing certain staff functions in a practice to outside contractors working in remote locations has become commonplace in many medical practices.

Health care outsourcing services, also known as virtual assistants (VAs), were already booming in 2017, when volume grew by 36%. Then, the COVID-19 pandemic in 2020 normalized off-site work, which was a boon to outsourcing providers.

The most popular services being outsourced today by medical practices include billing, scribes, telephone calls to patients, and processing prior authorizations.

“Outsourcing is not for everyone, but I’ve seen it work for many practices,” said Lara Hochman, MD, a practice management consultant in Austin, Tex. She said that practices have used outsourcing to solve problems like high staff turnover, tight budgets, and inefficient use of staff.

When in-house staffing is insufficient or not appropriately aligned with the task, outsourcing can produce big savings, said Teri Deabler, a practice management consultant with the Texas Medical Association.

For example, she said that a client was paying an in-house accountant $80,000 a year. When the accountant retired, she was replaced with a part-time bookkeeper earning $20,000 while her accounting work was outsourced at a cost of $20,000 a year. “The practice’s costs for this service were cut in half,” Ms. Deabler said.
 

What functions lend themselves to outsourcing?

Clinical services are rarely outsourced by individual practices – although hospitals now outsource numerous clinical services – but virtually any kind of administrative service can be contracted out. Outsourcing used to be limited mainly to billing and off-hours phone services, but today, more services are available, such as scribing, processing prior authorizations, accounting and bookkeeping, human resources (HR) and payroll, interactions with social media, recredentialing, medical transcription, and marketing.

Meanwhile, the original outsourced services have evolved. Billing and collections may now be handled by off-shore VAs, and phone services now deal with a wider variety of tasks, such as answering patients’ questions, scheduling appointments, and making referrals.

Ron Holder, chief operating officer of Medical Group Management Association in Englewood, Colo., said that some outsourcing services can also adjust the amount of work provided based on the customer’s needs. “For instance, an IT outsourcer may allow you to scale up IT support for a new big tech project, such as installing a new electronic health record,” he said.

The outsourced service provider, who might work in another state or another country, is connected to the practice by phone and electronically, and represents the practice when dealing with patients, insurers, or other vendors.

“No one, including patients and your physicians, should know that they are dealing with an outsourced company,” said Mr. Holder. “The work, look, and feel of the outsourced functions should be seamless. Employees at the outsourcer should always identify themselves as the practice, not the outsourcing service.”

Dr. Hochman said that many outsourcing companies dedicate a particular worker to a particular practice and train them to work there. One example of this approach is Provider’s Choice Scribe Services, based in San Antonio. On its website, the company notes that each scribe is paired with a doctor and learns his or her documentation preferences, EMR use, and charting requirements.
 

What medical practices benefit most from outsourcing?

All kinds and sizes of practices contract with outsourcing firms, but the arrangement is particularly useful for smaller practices, Mr. Holder said. “Larger practices have the economies of scale that allow services to be in-house,” he said, “but smaller practices don’t have that opportunity.”

Dr. Hochman added that outsourcing firms can be hired part-time when the practice doesn’t have enough work for a full-time position. Alternatively, a full-time outsourcing firm can perform two or more separate tasks, such as scribing while handling prior authorizations, she said.

Outsourcing is also useful for new practices, Ms. Deabler said. “A new practice is not earning much money, so it has to have a bare-bones staff,” she said. “Billing, for example, should be contracted out, but it won’t cost that much, because the outsourcer typically charges by volume, and the volume in a new practice is low.”

Meanwhile, Mr. Holder said that the outsourcing of prior authorization work can particularly benefit specialty practices because they typically have a lot of prior authorizations to deal with.
 

The pros and cons of outsourcing

Experts with experience in outsourcing agree there are both pluses and minuses. “Practices with outsourced workers have less overhead, don’t have to deal with staff turnover, and costs may be lower than for in-house staff,” Ms. Deabler said. “However, you have limited control over outsourced workers and the practice may seem more anonymous to patients, so you need to consider this option very carefully.”

“With outsourcing, you lose control,” said John Machata, MD, a recently retired solo family physician in Wickford, R.I. “You’re trusting someone else to do work that you could do anyway.”

When he briefly considered outsourcing the practice’s billing many years ago, he found that billing companies wouldn’t handle bills that took a lot of work, such as getting in touch with the insurance company and explaining the patient’s situation. “They would only handle the easy bills, which the practice could do anyway,” he said.

However, he does think that answering services may be useful to outsource. “Patients are more inclined to call an anonymous entity than the doctor,” he said. When he gave patients his cell phone number, he said that some patients held off from calling because they didn’t want to bother him.

“Outsourced staff should be less expensive than in-house staff,” said Daniel Shay, an attorney at Gosfield & Associates in Philadelphia. “On the other hand, you are liable for the outsourcer’s mistakes. If your outsourced billing company is upcoding claims, your practice would be on the hook for repayment and penalties.”

Mr. Holder said: “An outsourcer ought to be more efficient at its chosen task because that is what they know how to do. This is a plus at a small practice, where the practice manager may need to do the billing, HR, IT, marketing, some legal work, and accounting,” he said. “No one person can do all of those things well.”

He added, however, “If you choose outsourcing and then decide you don’t like it, it’s difficult to unwind the arrangement. Staff that have been dismissed can’t easily be hired back, so it shouldn’t be an easy decision to make.”

Also, sometimes the staff at offshore outsourcing firms may have accents that are harder for patients to understand, and the offshore staff may not readily understand a U.S. caller. However, Dr. Hochman said that practices often have a chance to interview and select specific persons on the offshore team who best fit their needs.
 

Offshore outsourcing

Outsourcing firms have been moving abroad, where costs are lower. Typical venues are India and the Philippines because there are larger percentages of people who speak English. Since 2020, demand at offshore medical billing companies has been growing faster than their domestic counterparts, according to a recent analysis.

The difference in price can be substantial. In 2020, the average salary for scribes in India was $500 a month, compared with $2,500 for scribes in the United States.

However, offshore outsourcing is starting to face limitations in some places because of privacy issues, according to David J. Zetter, a practice management consultant in Mechanicsburg, Pa. He pointed to a new Florida law that limits use of offshore vendors because they deal with confidential patient information. The law, which became effective July 1, requires that any protected health information must be maintained in the United States or Canada.

“This will make it very hard for many types of offshore vendors to operate in Florida,” he said. He noted that Florida is the only state with such a restriction, but similar proposals are under consideration in a few other states, such as Texas.
 

How to select the right company

Mr. Zetter said that the biggest mistake practices make when choosing a company is failing to take enough time to examine their choice. “Quite often, practices don’t validate that companies know what they are doing,” he said. “They get a recommendation and go with it.”

“Choose a company with experience in your specialty,” Mr. Zetter advised. “Speak with the company’s clients, not just the ones the company gives you to speak to. You should ask for the full list of clients and speak to all of them.”

Ms. Deabler said that it’s fairly easy to find respected outsourcing companies. “Colleagues can make recommendations, state and specialty societies can provide lists of preferred vendors, and you can visit vendors’ booths at medical conferences,” she said. She added that it’s also easy to find evaluations of each company. “You can Google the company and come up with all kinds of information about it,” she said.

Mr. Shay said that practices should make sure they understand the terms of the contract with a VA. “Depending on how the contract is worded, you may be stuck with the relationship for many years,” he said. “Before you sign an outsourcing contract, you need to make sure it has a reasonable termination provision.”

Because vetting companies properly can require extensive work, Ms. Deabler said, the work can be given to an experienced practice management consultant. “The consultant can start with a cost-benefit analysis that will show you whether outsourcing would be worthwhile,” she said.
 

Working with outsource service providers

Mr. Holder said that doctors should keep track of what the outsourcer is doing rather than simply let them do their work. “For example, doctors should understand the billing codes they use most often, such as the five levels of evaluation and management codes, and not just blindly rely on the billing company to code and bill their work correctly,” he noted.

Ms. Deabler said that companies provide monthly reports on their work. “Doctors should be reading these reports and contacting the company if expectations aren’t met,” she said.

Even in the reports, companies can hide problems from untrained eyes, Mr. Holder said. “For example, anyone can meet a metric like days in accounts receivable simply by writing off any charge that isn’t paid after 90 days.”

“You need to be engaged with the outsourcer,” he said. “It’s also a good idea to bring in a consultant to periodically check an outsourcer’s work.”
 

Will outsourcing expand in the future?

Mr. Holder said that the increasing use of value-based care may require practices to rely more on outsourcing in the future. “For instance, if a practice has a value-based contract that requires providing behavioral health services to patients, it might make sense to outsource that work rather than hire psychologists in-house,” he said.

Practices rarely outsource clinical services, but Mr. Holder said that this may happen in the future: “Now that Medicare is paying less for telehealth, practices have to find a way to provide it without using expensive examining room space,” he said. “Some practices may decide to outsource telehealth instead.”

Mr. Shay said that there are many reasons why outsourcing has a strong future. “It allows you to concentrate on your clinical care, and it is a solution to problems with turnover of in-house staff,” he said. “It can also be more efficient because the service is presumably an expert in areas like billing and collections, which means it may be able to ensure more efficient and faster reimbursements. And if the work is outsourced overseas, you can save money through lower worker salaries.”

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

Outsourcing certain staff functions in a practice to outside contractors working in remote locations has become commonplace in many medical practices.

Health care outsourcing services, also known as virtual assistants (VAs), were already booming in 2017, when volume grew by 36%. Then, the COVID-19 pandemic in 2020 normalized off-site work, which was a boon to outsourcing providers.

The most popular services being outsourced today by medical practices include billing, scribes, telephone calls to patients, and processing prior authorizations.

“Outsourcing is not for everyone, but I’ve seen it work for many practices,” said Lara Hochman, MD, a practice management consultant in Austin, Tex. She said that practices have used outsourcing to solve problems like high staff turnover, tight budgets, and inefficient use of staff.

When in-house staffing is insufficient or not appropriately aligned with the task, outsourcing can produce big savings, said Teri Deabler, a practice management consultant with the Texas Medical Association.

For example, she said that a client was paying an in-house accountant $80,000 a year. When the accountant retired, she was replaced with a part-time bookkeeper earning $20,000 while her accounting work was outsourced at a cost of $20,000 a year. “The practice’s costs for this service were cut in half,” Ms. Deabler said.
 

What functions lend themselves to outsourcing?

Clinical services are rarely outsourced by individual practices – although hospitals now outsource numerous clinical services – but virtually any kind of administrative service can be contracted out. Outsourcing used to be limited mainly to billing and off-hours phone services, but today, more services are available, such as scribing, processing prior authorizations, accounting and bookkeeping, human resources (HR) and payroll, interactions with social media, recredentialing, medical transcription, and marketing.

Meanwhile, the original outsourced services have evolved. Billing and collections may now be handled by off-shore VAs, and phone services now deal with a wider variety of tasks, such as answering patients’ questions, scheduling appointments, and making referrals.

Ron Holder, chief operating officer of Medical Group Management Association in Englewood, Colo., said that some outsourcing services can also adjust the amount of work provided based on the customer’s needs. “For instance, an IT outsourcer may allow you to scale up IT support for a new big tech project, such as installing a new electronic health record,” he said.

The outsourced service provider, who might work in another state or another country, is connected to the practice by phone and electronically, and represents the practice when dealing with patients, insurers, or other vendors.

“No one, including patients and your physicians, should know that they are dealing with an outsourced company,” said Mr. Holder. “The work, look, and feel of the outsourced functions should be seamless. Employees at the outsourcer should always identify themselves as the practice, not the outsourcing service.”

Dr. Hochman said that many outsourcing companies dedicate a particular worker to a particular practice and train them to work there. One example of this approach is Provider’s Choice Scribe Services, based in San Antonio. On its website, the company notes that each scribe is paired with a doctor and learns his or her documentation preferences, EMR use, and charting requirements.
 

What medical practices benefit most from outsourcing?

All kinds and sizes of practices contract with outsourcing firms, but the arrangement is particularly useful for smaller practices, Mr. Holder said. “Larger practices have the economies of scale that allow services to be in-house,” he said, “but smaller practices don’t have that opportunity.”

Dr. Hochman added that outsourcing firms can be hired part-time when the practice doesn’t have enough work for a full-time position. Alternatively, a full-time outsourcing firm can perform two or more separate tasks, such as scribing while handling prior authorizations, she said.

Outsourcing is also useful for new practices, Ms. Deabler said. “A new practice is not earning much money, so it has to have a bare-bones staff,” she said. “Billing, for example, should be contracted out, but it won’t cost that much, because the outsourcer typically charges by volume, and the volume in a new practice is low.”

Meanwhile, Mr. Holder said that the outsourcing of prior authorization work can particularly benefit specialty practices because they typically have a lot of prior authorizations to deal with.
 

The pros and cons of outsourcing

Experts with experience in outsourcing agree there are both pluses and minuses. “Practices with outsourced workers have less overhead, don’t have to deal with staff turnover, and costs may be lower than for in-house staff,” Ms. Deabler said. “However, you have limited control over outsourced workers and the practice may seem more anonymous to patients, so you need to consider this option very carefully.”

“With outsourcing, you lose control,” said John Machata, MD, a recently retired solo family physician in Wickford, R.I. “You’re trusting someone else to do work that you could do anyway.”

When he briefly considered outsourcing the practice’s billing many years ago, he found that billing companies wouldn’t handle bills that took a lot of work, such as getting in touch with the insurance company and explaining the patient’s situation. “They would only handle the easy bills, which the practice could do anyway,” he said.

However, he does think that answering services may be useful to outsource. “Patients are more inclined to call an anonymous entity than the doctor,” he said. When he gave patients his cell phone number, he said that some patients held off from calling because they didn’t want to bother him.

“Outsourced staff should be less expensive than in-house staff,” said Daniel Shay, an attorney at Gosfield & Associates in Philadelphia. “On the other hand, you are liable for the outsourcer’s mistakes. If your outsourced billing company is upcoding claims, your practice would be on the hook for repayment and penalties.”

Mr. Holder said: “An outsourcer ought to be more efficient at its chosen task because that is what they know how to do. This is a plus at a small practice, where the practice manager may need to do the billing, HR, IT, marketing, some legal work, and accounting,” he said. “No one person can do all of those things well.”

He added, however, “If you choose outsourcing and then decide you don’t like it, it’s difficult to unwind the arrangement. Staff that have been dismissed can’t easily be hired back, so it shouldn’t be an easy decision to make.”

Also, sometimes the staff at offshore outsourcing firms may have accents that are harder for patients to understand, and the offshore staff may not readily understand a U.S. caller. However, Dr. Hochman said that practices often have a chance to interview and select specific persons on the offshore team who best fit their needs.
 

Offshore outsourcing

Outsourcing firms have been moving abroad, where costs are lower. Typical venues are India and the Philippines because there are larger percentages of people who speak English. Since 2020, demand at offshore medical billing companies has been growing faster than their domestic counterparts, according to a recent analysis.

The difference in price can be substantial. In 2020, the average salary for scribes in India was $500 a month, compared with $2,500 for scribes in the United States.

However, offshore outsourcing is starting to face limitations in some places because of privacy issues, according to David J. Zetter, a practice management consultant in Mechanicsburg, Pa. He pointed to a new Florida law that limits use of offshore vendors because they deal with confidential patient information. The law, which became effective July 1, requires that any protected health information must be maintained in the United States or Canada.

“This will make it very hard for many types of offshore vendors to operate in Florida,” he said. He noted that Florida is the only state with such a restriction, but similar proposals are under consideration in a few other states, such as Texas.
 

How to select the right company

Mr. Zetter said that the biggest mistake practices make when choosing a company is failing to take enough time to examine their choice. “Quite often, practices don’t validate that companies know what they are doing,” he said. “They get a recommendation and go with it.”

“Choose a company with experience in your specialty,” Mr. Zetter advised. “Speak with the company’s clients, not just the ones the company gives you to speak to. You should ask for the full list of clients and speak to all of them.”

Ms. Deabler said that it’s fairly easy to find respected outsourcing companies. “Colleagues can make recommendations, state and specialty societies can provide lists of preferred vendors, and you can visit vendors’ booths at medical conferences,” she said. She added that it’s also easy to find evaluations of each company. “You can Google the company and come up with all kinds of information about it,” she said.

Mr. Shay said that practices should make sure they understand the terms of the contract with a VA. “Depending on how the contract is worded, you may be stuck with the relationship for many years,” he said. “Before you sign an outsourcing contract, you need to make sure it has a reasonable termination provision.”

Because vetting companies properly can require extensive work, Ms. Deabler said, the work can be given to an experienced practice management consultant. “The consultant can start with a cost-benefit analysis that will show you whether outsourcing would be worthwhile,” she said.
 

Working with outsource service providers

Mr. Holder said that doctors should keep track of what the outsourcer is doing rather than simply let them do their work. “For example, doctors should understand the billing codes they use most often, such as the five levels of evaluation and management codes, and not just blindly rely on the billing company to code and bill their work correctly,” he noted.

Ms. Deabler said that companies provide monthly reports on their work. “Doctors should be reading these reports and contacting the company if expectations aren’t met,” she said.

Even in the reports, companies can hide problems from untrained eyes, Mr. Holder said. “For example, anyone can meet a metric like days in accounts receivable simply by writing off any charge that isn’t paid after 90 days.”

“You need to be engaged with the outsourcer,” he said. “It’s also a good idea to bring in a consultant to periodically check an outsourcer’s work.”
 

Will outsourcing expand in the future?

Mr. Holder said that the increasing use of value-based care may require practices to rely more on outsourcing in the future. “For instance, if a practice has a value-based contract that requires providing behavioral health services to patients, it might make sense to outsource that work rather than hire psychologists in-house,” he said.

Practices rarely outsource clinical services, but Mr. Holder said that this may happen in the future: “Now that Medicare is paying less for telehealth, practices have to find a way to provide it without using expensive examining room space,” he said. “Some practices may decide to outsource telehealth instead.”

Mr. Shay said that there are many reasons why outsourcing has a strong future. “It allows you to concentrate on your clinical care, and it is a solution to problems with turnover of in-house staff,” he said. “It can also be more efficient because the service is presumably an expert in areas like billing and collections, which means it may be able to ensure more efficient and faster reimbursements. And if the work is outsourced overseas, you can save money through lower worker salaries.”

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

Outsourcing certain staff functions in a practice to outside contractors working in remote locations has become commonplace in many medical practices.

Health care outsourcing services, also known as virtual assistants (VAs), were already booming in 2017, when volume grew by 36%. Then, the COVID-19 pandemic in 2020 normalized off-site work, which was a boon to outsourcing providers.

The most popular services being outsourced today by medical practices include billing, scribes, telephone calls to patients, and processing prior authorizations.

“Outsourcing is not for everyone, but I’ve seen it work for many practices,” said Lara Hochman, MD, a practice management consultant in Austin, Tex. She said that practices have used outsourcing to solve problems like high staff turnover, tight budgets, and inefficient use of staff.

When in-house staffing is insufficient or not appropriately aligned with the task, outsourcing can produce big savings, said Teri Deabler, a practice management consultant with the Texas Medical Association.

For example, she said that a client was paying an in-house accountant $80,000 a year. When the accountant retired, she was replaced with a part-time bookkeeper earning $20,000 while her accounting work was outsourced at a cost of $20,000 a year. “The practice’s costs for this service were cut in half,” Ms. Deabler said.
 

What functions lend themselves to outsourcing?

Clinical services are rarely outsourced by individual practices – although hospitals now outsource numerous clinical services – but virtually any kind of administrative service can be contracted out. Outsourcing used to be limited mainly to billing and off-hours phone services, but today, more services are available, such as scribing, processing prior authorizations, accounting and bookkeeping, human resources (HR) and payroll, interactions with social media, recredentialing, medical transcription, and marketing.

Meanwhile, the original outsourced services have evolved. Billing and collections may now be handled by off-shore VAs, and phone services now deal with a wider variety of tasks, such as answering patients’ questions, scheduling appointments, and making referrals.

Ron Holder, chief operating officer of Medical Group Management Association in Englewood, Colo., said that some outsourcing services can also adjust the amount of work provided based on the customer’s needs. “For instance, an IT outsourcer may allow you to scale up IT support for a new big tech project, such as installing a new electronic health record,” he said.

The outsourced service provider, who might work in another state or another country, is connected to the practice by phone and electronically, and represents the practice when dealing with patients, insurers, or other vendors.

“No one, including patients and your physicians, should know that they are dealing with an outsourced company,” said Mr. Holder. “The work, look, and feel of the outsourced functions should be seamless. Employees at the outsourcer should always identify themselves as the practice, not the outsourcing service.”

Dr. Hochman said that many outsourcing companies dedicate a particular worker to a particular practice and train them to work there. One example of this approach is Provider’s Choice Scribe Services, based in San Antonio. On its website, the company notes that each scribe is paired with a doctor and learns his or her documentation preferences, EMR use, and charting requirements.
 

What medical practices benefit most from outsourcing?

All kinds and sizes of practices contract with outsourcing firms, but the arrangement is particularly useful for smaller practices, Mr. Holder said. “Larger practices have the economies of scale that allow services to be in-house,” he said, “but smaller practices don’t have that opportunity.”

Dr. Hochman added that outsourcing firms can be hired part-time when the practice doesn’t have enough work for a full-time position. Alternatively, a full-time outsourcing firm can perform two or more separate tasks, such as scribing while handling prior authorizations, she said.

Outsourcing is also useful for new practices, Ms. Deabler said. “A new practice is not earning much money, so it has to have a bare-bones staff,” she said. “Billing, for example, should be contracted out, but it won’t cost that much, because the outsourcer typically charges by volume, and the volume in a new practice is low.”

Meanwhile, Mr. Holder said that the outsourcing of prior authorization work can particularly benefit specialty practices because they typically have a lot of prior authorizations to deal with.
 

The pros and cons of outsourcing

Experts with experience in outsourcing agree there are both pluses and minuses. “Practices with outsourced workers have less overhead, don’t have to deal with staff turnover, and costs may be lower than for in-house staff,” Ms. Deabler said. “However, you have limited control over outsourced workers and the practice may seem more anonymous to patients, so you need to consider this option very carefully.”

“With outsourcing, you lose control,” said John Machata, MD, a recently retired solo family physician in Wickford, R.I. “You’re trusting someone else to do work that you could do anyway.”

When he briefly considered outsourcing the practice’s billing many years ago, he found that billing companies wouldn’t handle bills that took a lot of work, such as getting in touch with the insurance company and explaining the patient’s situation. “They would only handle the easy bills, which the practice could do anyway,” he said.

However, he does think that answering services may be useful to outsource. “Patients are more inclined to call an anonymous entity than the doctor,” he said. When he gave patients his cell phone number, he said that some patients held off from calling because they didn’t want to bother him.

“Outsourced staff should be less expensive than in-house staff,” said Daniel Shay, an attorney at Gosfield & Associates in Philadelphia. “On the other hand, you are liable for the outsourcer’s mistakes. If your outsourced billing company is upcoding claims, your practice would be on the hook for repayment and penalties.”

Mr. Holder said: “An outsourcer ought to be more efficient at its chosen task because that is what they know how to do. This is a plus at a small practice, where the practice manager may need to do the billing, HR, IT, marketing, some legal work, and accounting,” he said. “No one person can do all of those things well.”

He added, however, “If you choose outsourcing and then decide you don’t like it, it’s difficult to unwind the arrangement. Staff that have been dismissed can’t easily be hired back, so it shouldn’t be an easy decision to make.”

Also, sometimes the staff at offshore outsourcing firms may have accents that are harder for patients to understand, and the offshore staff may not readily understand a U.S. caller. However, Dr. Hochman said that practices often have a chance to interview and select specific persons on the offshore team who best fit their needs.
 

Offshore outsourcing

Outsourcing firms have been moving abroad, where costs are lower. Typical venues are India and the Philippines because there are larger percentages of people who speak English. Since 2020, demand at offshore medical billing companies has been growing faster than their domestic counterparts, according to a recent analysis.

The difference in price can be substantial. In 2020, the average salary for scribes in India was $500 a month, compared with $2,500 for scribes in the United States.

However, offshore outsourcing is starting to face limitations in some places because of privacy issues, according to David J. Zetter, a practice management consultant in Mechanicsburg, Pa. He pointed to a new Florida law that limits use of offshore vendors because they deal with confidential patient information. The law, which became effective July 1, requires that any protected health information must be maintained in the United States or Canada.

“This will make it very hard for many types of offshore vendors to operate in Florida,” he said. He noted that Florida is the only state with such a restriction, but similar proposals are under consideration in a few other states, such as Texas.
 

How to select the right company

Mr. Zetter said that the biggest mistake practices make when choosing a company is failing to take enough time to examine their choice. “Quite often, practices don’t validate that companies know what they are doing,” he said. “They get a recommendation and go with it.”

“Choose a company with experience in your specialty,” Mr. Zetter advised. “Speak with the company’s clients, not just the ones the company gives you to speak to. You should ask for the full list of clients and speak to all of them.”

Ms. Deabler said that it’s fairly easy to find respected outsourcing companies. “Colleagues can make recommendations, state and specialty societies can provide lists of preferred vendors, and you can visit vendors’ booths at medical conferences,” she said. She added that it’s also easy to find evaluations of each company. “You can Google the company and come up with all kinds of information about it,” she said.

Mr. Shay said that practices should make sure they understand the terms of the contract with a VA. “Depending on how the contract is worded, you may be stuck with the relationship for many years,” he said. “Before you sign an outsourcing contract, you need to make sure it has a reasonable termination provision.”

Because vetting companies properly can require extensive work, Ms. Deabler said, the work can be given to an experienced practice management consultant. “The consultant can start with a cost-benefit analysis that will show you whether outsourcing would be worthwhile,” she said.
 

Working with outsource service providers

Mr. Holder said that doctors should keep track of what the outsourcer is doing rather than simply let them do their work. “For example, doctors should understand the billing codes they use most often, such as the five levels of evaluation and management codes, and not just blindly rely on the billing company to code and bill their work correctly,” he noted.

Ms. Deabler said that companies provide monthly reports on their work. “Doctors should be reading these reports and contacting the company if expectations aren’t met,” she said.

Even in the reports, companies can hide problems from untrained eyes, Mr. Holder said. “For example, anyone can meet a metric like days in accounts receivable simply by writing off any charge that isn’t paid after 90 days.”

“You need to be engaged with the outsourcer,” he said. “It’s also a good idea to bring in a consultant to periodically check an outsourcer’s work.”
 

Will outsourcing expand in the future?

Mr. Holder said that the increasing use of value-based care may require practices to rely more on outsourcing in the future. “For instance, if a practice has a value-based contract that requires providing behavioral health services to patients, it might make sense to outsource that work rather than hire psychologists in-house,” he said.

Practices rarely outsource clinical services, but Mr. Holder said that this may happen in the future: “Now that Medicare is paying less for telehealth, practices have to find a way to provide it without using expensive examining room space,” he said. “Some practices may decide to outsource telehealth instead.”

Mr. Shay said that there are many reasons why outsourcing has a strong future. “It allows you to concentrate on your clinical care, and it is a solution to problems with turnover of in-house staff,” he said. “It can also be more efficient because the service is presumably an expert in areas like billing and collections, which means it may be able to ensure more efficient and faster reimbursements. And if the work is outsourced overseas, you can save money through lower worker salaries.”

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

The combination of heat waves and poor air quality is associated with double the risk of fatal myocardial infarction (MI), with women and older adults at greatest risk, a study from China suggests.

rottadana/Thinkstock

The researchers estimate that up to 3% of all deaths due to MI could be attributed to the combination of extreme temperatures and high levels of ambient fine particulate matter (PM2.5).

“Our findings provide evidence that reducing exposure to both extreme temperatures and fine particulate pollution may be useful to prevent premature deaths from heart attack,” senior author Yuewei Liu, MD, PhD, with Sun Yat-sen University in Guangzhou, China, said in a statement.

There is “long-standing evidence” of the harmful cardiovascular effects of air pollution, Jonathan Newman, MD, MPH, cardiologist at NYU Langone Heart in New York, who wasn’t involved in the study, said in an interview.

The added value of this study was finding an interaction between extreme hot temperatures and air pollution, “which is worrisome with global warming,” said Dr. Newman, assistant professor, department of medicine, the Leon H. Charney Division of Cardiology at NYU Langone Health.

The study was published online in Circulation.
 

Intensity and duration matter

The researchers analyzed data on 202,678 adults (mean age, 77.6 years; 52% male) who suffered fatal MI between 2015 and 2020 in Jiangsu province, a region with four distinct seasons and a wide range of temperatures and ambient PM2.5.

They evaluated the association of exposure to extreme temperature events, including both hot and cold spells, and PM2.5 with MI mortality, and their interactive effects.

Among the key findings:

• The risk of fatal MI was 18% higher during 2-day heat waves with heat indexes at or above the 90th percentile (ranging from 82.6° to 97.9° F) and 74% higher during 4-day heat waves with heat indexes at or above the 97.5th percentile (ranging from 94.8° to 109.4° F), compared with control days.
• The risk of fatal MI was 4% higher during 2-day cold snaps with temperatures at or below the 10th percentile (ranging from 33.3° to 40.5° F) and 12% higher during 3-day cold snaps with temperatures at or below the 2.5th percentile (ranging from 27.0° to 37.2° F).
• The risk of fatal MI was twice as high during 4-day heat waves that had PM2.5 above 37.5 mcg/m³. Days with high levels of PM2.5 during cold snaps did not have an equivalent increase in the risk of fatal MI.
• Up to 2.8% of MI deaths during the 5-year study period may be attributable to the combination of extreme temperature exposure and PM2.5 at levels exceeding World Health Organization air quality guidelines (37.5 mcg/m³).
• The risk of fatal MI was generally higher among women than men during heat waves and was higher among adults 80 years old and older than in younger adults during heat waves, cold snaps, or days with high levels of PM2.5.

The finding that adults over age 80 are particularly susceptible to the effects of heat and air pollution and the interaction of the two is “notable and particularly relevant given the aging of the population,” Dr. Newman told this news organization.

Mitigating both extreme temperature events and PM2.5 exposures “may bring health cobenefits in preventing premature deaths from MI,” the researchers write.

“To improve public health, it is important to take fine particulate pollution into consideration when providing extreme temperature warnings to the public,” Dr. Liu adds in the statement.

In an earlier study, Dr. Liu and colleagues showed that exposure to both large and small particulate matter, as well as nitrogen dioxide, was significantly associated with increased odds of death from MI.

This study was funded by China’s Ministry of Science and Technology. The authors and Dr. Newman have disclosed no relevant financial relationships.

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

The combination of heat waves and poor air quality is associated with double the risk of fatal myocardial infarction (MI), with women and older adults at greatest risk, a study from China suggests.

rottadana/Thinkstock

The researchers estimate that up to 3% of all deaths due to MI could be attributed to the combination of extreme temperatures and high levels of ambient fine particulate matter (PM2.5).

“Our findings provide evidence that reducing exposure to both extreme temperatures and fine particulate pollution may be useful to prevent premature deaths from heart attack,” senior author Yuewei Liu, MD, PhD, with Sun Yat-sen University in Guangzhou, China, said in a statement.

There is “long-standing evidence” of the harmful cardiovascular effects of air pollution, Jonathan Newman, MD, MPH, cardiologist at NYU Langone Heart in New York, who wasn’t involved in the study, said in an interview.

The added value of this study was finding an interaction between extreme hot temperatures and air pollution, “which is worrisome with global warming,” said Dr. Newman, assistant professor, department of medicine, the Leon H. Charney Division of Cardiology at NYU Langone Health.

The study was published online in Circulation.
 

Intensity and duration matter

The researchers analyzed data on 202,678 adults (mean age, 77.6 years; 52% male) who suffered fatal MI between 2015 and 2020 in Jiangsu province, a region with four distinct seasons and a wide range of temperatures and ambient PM2.5.

They evaluated the association of exposure to extreme temperature events, including both hot and cold spells, and PM2.5 with MI mortality, and their interactive effects.

Among the key findings:

• The risk of fatal MI was 18% higher during 2-day heat waves with heat indexes at or above the 90th percentile (ranging from 82.6° to 97.9° F) and 74% higher during 4-day heat waves with heat indexes at or above the 97.5th percentile (ranging from 94.8° to 109.4° F), compared with control days.
• The risk of fatal MI was 4% higher during 2-day cold snaps with temperatures at or below the 10th percentile (ranging from 33.3° to 40.5° F) and 12% higher during 3-day cold snaps with temperatures at or below the 2.5th percentile (ranging from 27.0° to 37.2° F).
• The risk of fatal MI was twice as high during 4-day heat waves that had PM2.5 above 37.5 mcg/m³. Days with high levels of PM2.5 during cold snaps did not have an equivalent increase in the risk of fatal MI.
• Up to 2.8% of MI deaths during the 5-year study period may be attributable to the combination of extreme temperature exposure and PM2.5 at levels exceeding World Health Organization air quality guidelines (37.5 mcg/m³).
• The risk of fatal MI was generally higher among women than men during heat waves and was higher among adults 80 years old and older than in younger adults during heat waves, cold snaps, or days with high levels of PM2.5.

The finding that adults over age 80 are particularly susceptible to the effects of heat and air pollution and the interaction of the two is “notable and particularly relevant given the aging of the population,” Dr. Newman told this news organization.

Mitigating both extreme temperature events and PM2.5 exposures “may bring health cobenefits in preventing premature deaths from MI,” the researchers write.

“To improve public health, it is important to take fine particulate pollution into consideration when providing extreme temperature warnings to the public,” Dr. Liu adds in the statement.

In an earlier study, Dr. Liu and colleagues showed that exposure to both large and small particulate matter, as well as nitrogen dioxide, was significantly associated with increased odds of death from MI.

This study was funded by China’s Ministry of Science and Technology. The authors and Dr. Newman have disclosed no relevant financial relationships.

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

The combination of heat waves and poor air quality is associated with double the risk of fatal myocardial infarction (MI), with women and older adults at greatest risk, a study from China suggests.

rottadana/Thinkstock

The researchers estimate that up to 3% of all deaths due to MI could be attributed to the combination of extreme temperatures and high levels of ambient fine particulate matter (PM2.5).

“Our findings provide evidence that reducing exposure to both extreme temperatures and fine particulate pollution may be useful to prevent premature deaths from heart attack,” senior author Yuewei Liu, MD, PhD, with Sun Yat-sen University in Guangzhou, China, said in a statement.

There is “long-standing evidence” of the harmful cardiovascular effects of air pollution, Jonathan Newman, MD, MPH, cardiologist at NYU Langone Heart in New York, who wasn’t involved in the study, said in an interview.

The added value of this study was finding an interaction between extreme hot temperatures and air pollution, “which is worrisome with global warming,” said Dr. Newman, assistant professor, department of medicine, the Leon H. Charney Division of Cardiology at NYU Langone Health.

The study was published online in Circulation.
 

Intensity and duration matter

The researchers analyzed data on 202,678 adults (mean age, 77.6 years; 52% male) who suffered fatal MI between 2015 and 2020 in Jiangsu province, a region with four distinct seasons and a wide range of temperatures and ambient PM2.5.

They evaluated the association of exposure to extreme temperature events, including both hot and cold spells, and PM2.5 with MI mortality, and their interactive effects.

Among the key findings:

• The risk of fatal MI was 18% higher during 2-day heat waves with heat indexes at or above the 90th percentile (ranging from 82.6° to 97.9° F) and 74% higher during 4-day heat waves with heat indexes at or above the 97.5th percentile (ranging from 94.8° to 109.4° F), compared with control days.
• The risk of fatal MI was 4% higher during 2-day cold snaps with temperatures at or below the 10th percentile (ranging from 33.3° to 40.5° F) and 12% higher during 3-day cold snaps with temperatures at or below the 2.5th percentile (ranging from 27.0° to 37.2° F).
• The risk of fatal MI was twice as high during 4-day heat waves that had PM2.5 above 37.5 mcg/m³. Days with high levels of PM2.5 during cold snaps did not have an equivalent increase in the risk of fatal MI.
• Up to 2.8% of MI deaths during the 5-year study period may be attributable to the combination of extreme temperature exposure and PM2.5 at levels exceeding World Health Organization air quality guidelines (37.5 mcg/m³).
• The risk of fatal MI was generally higher among women than men during heat waves and was higher among adults 80 years old and older than in younger adults during heat waves, cold snaps, or days with high levels of PM2.5.

The finding that adults over age 80 are particularly susceptible to the effects of heat and air pollution and the interaction of the two is “notable and particularly relevant given the aging of the population,” Dr. Newman told this news organization.

Mitigating both extreme temperature events and PM2.5 exposures “may bring health cobenefits in preventing premature deaths from MI,” the researchers write.

“To improve public health, it is important to take fine particulate pollution into consideration when providing extreme temperature warnings to the public,” Dr. Liu adds in the statement.

In an earlier study, Dr. Liu and colleagues showed that exposure to both large and small particulate matter, as well as nitrogen dioxide, was significantly associated with increased odds of death from MI.

This study was funded by China’s Ministry of Science and Technology. The authors and Dr. Newman have disclosed no relevant financial relationships.

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

Family members with pulmonary fibrosis showed correlations for predicted forced vital capacity trajectories and computed tomography patterns, based on data from 101 individuals in 45 families.

Patients with familial pulmonary fibrosis (FPF), defined as fibrotic interstitial lung disease among two or more first-degree or second-degree relatives, have worse survival than that of patients with sporadic pulmonary fibrosis, wrote Tinne Goos, MD, of KU Leuven, Belgium, and colleagues. Diagnosis of FPF diagnosis is mainly based on family history, and data on intrafamilial correlations are lacking, they said.

In a study published in the journal Chest, the researchers identified FPF patients treated at a single center. The study population included 101 patients from 45 families; most of these (34) were siblings. Overall, 61.4% of the participants were men, 69.3% were ever-smokers, and 84.2% had idiopathic pulmonary fibrosis.

The analysis included data on computed tomography (CT) scanning and predicted forced vital capacity (FVC%), as well as age at diagnosis, treatment type, gender, smoking history, and date of diagnosis.

Overall, FVC%predicted was significantly correlated within families, with a correlation of 0.75. The annual change in FVC was –158.2 mL, and the annual change in FVC%predicted was –6.3%.

Sixty-five patients received antifibrotic treatment, and 18 received immunosuppressive treatment. Immunosuppressive treatment remained significantly correlated among families in a multivariate analysis, with a correlation of 0.77.

“Age at diagnosis correlated within a generation, while patients from a second generation were diagnosed younger,” the researchers noted. The current study findings and results from other studies suggest a genetic basis for FPF age of onset, and determining an age range for screening unaffected relatives based on the age at diagnosis of affected relatives might be useful, they said.

In addition, 42.2% of families showed concordance of CT scan patterns. Typical usual interstitial pneumonia (UIP) appeared in 35 patients, atypical UIP in 36 patients, UIP with emphysema in 9 patients, and findings incompatible with UIP in 21 patients.

The study findings were limited by several factors including the retrospective design and use of data from a single center, as well as by the changes in clinical practice guidelines between 2004 and 2019, with increases in genetic testing, the researchers noted.

However, the current study is the first known to report on FVC evolution within families in FPF, they said. Future studies of both intra- and interfamilial correlation and variability are needed to identify the genetic and environmental factors that may affect disease manifestation and progression, they concluded.

The study was supported by Research Foundation-Flanders. Dr. Goos had no financial conflicts to disclose.

Family members with pulmonary fibrosis showed correlations for predicted forced vital capacity trajectories and computed tomography patterns, based on data from 101 individuals in 45 families.

Patients with familial pulmonary fibrosis (FPF), defined as fibrotic interstitial lung disease among two or more first-degree or second-degree relatives, have worse survival than that of patients with sporadic pulmonary fibrosis, wrote Tinne Goos, MD, of KU Leuven, Belgium, and colleagues. Diagnosis of FPF diagnosis is mainly based on family history, and data on intrafamilial correlations are lacking, they said.

In a study published in the journal Chest, the researchers identified FPF patients treated at a single center. The study population included 101 patients from 45 families; most of these (34) were siblings. Overall, 61.4% of the participants were men, 69.3% were ever-smokers, and 84.2% had idiopathic pulmonary fibrosis.

The analysis included data on computed tomography (CT) scanning and predicted forced vital capacity (FVC%), as well as age at diagnosis, treatment type, gender, smoking history, and date of diagnosis.

Overall, FVC%predicted was significantly correlated within families, with a correlation of 0.75. The annual change in FVC was –158.2 mL, and the annual change in FVC%predicted was –6.3%.

Sixty-five patients received antifibrotic treatment, and 18 received immunosuppressive treatment. Immunosuppressive treatment remained significantly correlated among families in a multivariate analysis, with a correlation of 0.77.

“Age at diagnosis correlated within a generation, while patients from a second generation were diagnosed younger,” the researchers noted. The current study findings and results from other studies suggest a genetic basis for FPF age of onset, and determining an age range for screening unaffected relatives based on the age at diagnosis of affected relatives might be useful, they said.

In addition, 42.2% of families showed concordance of CT scan patterns. Typical usual interstitial pneumonia (UIP) appeared in 35 patients, atypical UIP in 36 patients, UIP with emphysema in 9 patients, and findings incompatible with UIP in 21 patients.

The study findings were limited by several factors including the retrospective design and use of data from a single center, as well as by the changes in clinical practice guidelines between 2004 and 2019, with increases in genetic testing, the researchers noted.

However, the current study is the first known to report on FVC evolution within families in FPF, they said. Future studies of both intra- and interfamilial correlation and variability are needed to identify the genetic and environmental factors that may affect disease manifestation and progression, they concluded.

The study was supported by Research Foundation-Flanders. Dr. Goos had no financial conflicts to disclose.

Family members with pulmonary fibrosis showed correlations for predicted forced vital capacity trajectories and computed tomography patterns, based on data from 101 individuals in 45 families.

Patients with familial pulmonary fibrosis (FPF), defined as fibrotic interstitial lung disease among two or more first-degree or second-degree relatives, have worse survival than that of patients with sporadic pulmonary fibrosis, wrote Tinne Goos, MD, of KU Leuven, Belgium, and colleagues. Diagnosis of FPF diagnosis is mainly based on family history, and data on intrafamilial correlations are lacking, they said.

In a study published in the journal Chest, the researchers identified FPF patients treated at a single center. The study population included 101 patients from 45 families; most of these (34) were siblings. Overall, 61.4% of the participants were men, 69.3% were ever-smokers, and 84.2% had idiopathic pulmonary fibrosis.

The analysis included data on computed tomography (CT) scanning and predicted forced vital capacity (FVC%), as well as age at diagnosis, treatment type, gender, smoking history, and date of diagnosis.

Overall, FVC%predicted was significantly correlated within families, with a correlation of 0.75. The annual change in FVC was –158.2 mL, and the annual change in FVC%predicted was –6.3%.

Sixty-five patients received antifibrotic treatment, and 18 received immunosuppressive treatment. Immunosuppressive treatment remained significantly correlated among families in a multivariate analysis, with a correlation of 0.77.

“Age at diagnosis correlated within a generation, while patients from a second generation were diagnosed younger,” the researchers noted. The current study findings and results from other studies suggest a genetic basis for FPF age of onset, and determining an age range for screening unaffected relatives based on the age at diagnosis of affected relatives might be useful, they said.

In addition, 42.2% of families showed concordance of CT scan patterns. Typical usual interstitial pneumonia (UIP) appeared in 35 patients, atypical UIP in 36 patients, UIP with emphysema in 9 patients, and findings incompatible with UIP in 21 patients.

The study findings were limited by several factors including the retrospective design and use of data from a single center, as well as by the changes in clinical practice guidelines between 2004 and 2019, with increases in genetic testing, the researchers noted.

However, the current study is the first known to report on FVC evolution within families in FPF, they said. Future studies of both intra- and interfamilial correlation and variability are needed to identify the genetic and environmental factors that may affect disease manifestation and progression, they concluded.

The study was supported by Research Foundation-Flanders. Dr. Goos had no financial conflicts to disclose.

TOPLINE

A new American Academy of Pediatrics study reveals that 17.2% of toddlers started but did not finish at least one recommended early childhood vaccine series.

METHODOLOGY

• Examined data collected in 2019 from the National Immunization Survey – Child.
• 16,365 children ages 19-35 months were included.
• Vaccines for diphtheria, tetanus, acellular pertussis, pneumococcal infections, Haemophilus influenzae type b, hepatitis B, polio, measles, mumps, rubella, and varicella were included.

TAKEAWAY

• 72.9% of toddlers completed the seven-vaccine series.
• 17.2% initiated but did not complete one or more of a multidose vaccine series.
• The strongest association with not completing the vaccine series was moving across state lines and not having insurance.
• Children with more siblings at home were less likely to complete a vaccine series.

IN PRACTICE

The study suggests that the “children experienced structural barriers to vaccination,” and the authors urge an “increased focus on strategies to encourage multidose series completion ... to optimize protection from preventable diseases and achieve vaccination coverage goals.”

SOURCE

The study was funded by the National Institutes of Health and published online July 25 in Pediatrics. Sarah Y. Michels, an epidemiology specialist from the University of Montana in Missoula, was the lead author.

LIMITATIONS

Though the researchers studied the risk factors for series noncompletion, they did not have information on the specific reasons why children were missing vaccine doses. Children whose parents chose to participate in the National Immunization Survey – Child may have had higher vaccination coverage than children whose parents declined participation.

DISCLOSURES

The authors have reported no relevant financial relationships.

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

TOPLINE

A new American Academy of Pediatrics study reveals that 17.2% of toddlers started but did not finish at least one recommended early childhood vaccine series.

METHODOLOGY

• Examined data collected in 2019 from the National Immunization Survey – Child.
• 16,365 children ages 19-35 months were included.
• Vaccines for diphtheria, tetanus, acellular pertussis, pneumococcal infections, Haemophilus influenzae type b, hepatitis B, polio, measles, mumps, rubella, and varicella were included.

TAKEAWAY

• 72.9% of toddlers completed the seven-vaccine series.
• 17.2% initiated but did not complete one or more of a multidose vaccine series.
• The strongest association with not completing the vaccine series was moving across state lines and not having insurance.
• Children with more siblings at home were less likely to complete a vaccine series.

IN PRACTICE

The study suggests that the “children experienced structural barriers to vaccination,” and the authors urge an “increased focus on strategies to encourage multidose series completion ... to optimize protection from preventable diseases and achieve vaccination coverage goals.”

SOURCE

The study was funded by the National Institutes of Health and published online July 25 in Pediatrics. Sarah Y. Michels, an epidemiology specialist from the University of Montana in Missoula, was the lead author.

LIMITATIONS

Though the researchers studied the risk factors for series noncompletion, they did not have information on the specific reasons why children were missing vaccine doses. Children whose parents chose to participate in the National Immunization Survey – Child may have had higher vaccination coverage than children whose parents declined participation.

DISCLOSURES

The authors have reported no relevant financial relationships.

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

TOPLINE

A new American Academy of Pediatrics study reveals that 17.2% of toddlers started but did not finish at least one recommended early childhood vaccine series.

METHODOLOGY

• Examined data collected in 2019 from the National Immunization Survey – Child.
• 16,365 children ages 19-35 months were included.
• Vaccines for diphtheria, tetanus, acellular pertussis, pneumococcal infections, Haemophilus influenzae type b, hepatitis B, polio, measles, mumps, rubella, and varicella were included.

TAKEAWAY

• 72.9% of toddlers completed the seven-vaccine series.
• 17.2% initiated but did not complete one or more of a multidose vaccine series.
• The strongest association with not completing the vaccine series was moving across state lines and not having insurance.
• Children with more siblings at home were less likely to complete a vaccine series.

IN PRACTICE

The study suggests that the “children experienced structural barriers to vaccination,” and the authors urge an “increased focus on strategies to encourage multidose series completion ... to optimize protection from preventable diseases and achieve vaccination coverage goals.”

SOURCE

The study was funded by the National Institutes of Health and published online July 25 in Pediatrics. Sarah Y. Michels, an epidemiology specialist from the University of Montana in Missoula, was the lead author.

LIMITATIONS

Though the researchers studied the risk factors for series noncompletion, they did not have information on the specific reasons why children were missing vaccine doses. Children whose parents chose to participate in the National Immunization Survey – Child may have had higher vaccination coverage than children whose parents declined participation.

DISCLOSURES

The authors have reported no relevant financial relationships.

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

Two newly approved respiratory syncytial virus (RSV) vaccines for adults aged 60 years and older may be able to prevent illness in those at risk for severe RSV disease.

Most adult RSV illness occurs among the older age group and results in an estimated 60,000-160,000 hospitalizations and 6,000-10,000 deaths per year among people aged at least 65 years.

Older adults deciding whether to get the vaccines should weigh risks and their own preferences and make the decision in consultation with their clinicians, said authors of a Centers for Disease Control and Prevention report.

Michael Melgar, MD, with the Coronavirus and Other Respiratory Viruses Division at the CDC, was lead author on the report, published in the Morbidity and Mortality Weekly Report.
 

Two new vaccines

In May, the Food and Drug Administration approved the first of two vaccines for preventing RSV lower respiratory tract disease for adults aged at least 60 years.

On June 21, the Advisory Committee on Immunization Practices (ACIP) recommended that people in that age group receive a single dose of RSV vaccine using shared decision-making.

The recommendation for shared decision-making makes the ACIP decision different from routine and risk-based vaccine recommendations. Rather than targeting all in a particular age group or risk group, the decision calls for consideration of a patients’ risk for disease and their characteristics, preferences, and values; the health care professional’s clinical discretion; and performance of the vaccine.

Dr. Melgar and colleagues reported that vaccination with one dose of the GSK or Pfizer RSV vaccines has proved moderately to highly effective in preventing symptomatic RSV-associated lower respiratory tract disease over two consecutive RSV seasons among people aged 60 and older.

The trials that led to approval weren’t powered to gauge efficacy against RSV-associated hospitalization and death. However, the authors wrote, the prevention of lower respiratory tract disease, including medically attended illness, suggests that the shots might prevent considerable morbidity from RSV disease among those aged 60 and older.

Both vaccines were generally well tolerated with a good safety profile. However, six cases of inflammatory neurologic events (including Guillain-Barré Syndrome, acute disseminated encephalomyelitis, and others) were reported in clinical trials after RSV vaccination.

“Whether these events occurred due to chance, or whether RSV vaccination increases the risk for inflammatory neurologic events, is currently unknown,” the authors wrote.

Postmarketing surveillance may help clarify the existence of any potential risk, but until those results are clearer, the CDC researchers said, RSV vaccinations should be targeted to older adults at highest risk for severe RSV and those most likely to benefit from the shots.
 

At higher risk

Some adults with certain medical conditions have a higher risk for RSV-associated hospitalization, according to the report.

Those conditions include chronic obstructive pulmonary disease, asthma, heart failure, coronary artery disease, cerebrovascular disease, diabetes mellitus, and chronic kidney disease.

People who are frail and of advanced age also are at higher risk for RSV hospitalization. That risk increases with age and the highest risk is for people aged at least 75 years.

The researchers added that RSV can cause severe disease in those with compromised immunity, including people who have received hematopoietic stem cell transplants and patients taking immunosuppressive drugs such as those used with solid organ transplants, cancer treatment, or other conditions.

As for when physicians should offer the vaccinations, shots are optimally given before the start of the RSV season.

However, the COVID-19 pandemic interrupted the seasonality and the timing has not yet returned to prepandemic patterns.

For the 2023-24 season, this report states, clinicians should offer RSV vaccination to adults aged at least 60 years using shared clinical decision-making as early as vaccine supply is available and should continue to offer vaccination to eligible adults who remain unvaccinated.

RSV vaccines can be administered with other adult vaccines during the same visit, the authors confirmed.
 

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

Two newly approved respiratory syncytial virus (RSV) vaccines for adults aged 60 years and older may be able to prevent illness in those at risk for severe RSV disease.

Most adult RSV illness occurs among the older age group and results in an estimated 60,000-160,000 hospitalizations and 6,000-10,000 deaths per year among people aged at least 65 years.

Older adults deciding whether to get the vaccines should weigh risks and their own preferences and make the decision in consultation with their clinicians, said authors of a Centers for Disease Control and Prevention report.

Michael Melgar, MD, with the Coronavirus and Other Respiratory Viruses Division at the CDC, was lead author on the report, published in the Morbidity and Mortality Weekly Report.
 

Two new vaccines

In May, the Food and Drug Administration approved the first of two vaccines for preventing RSV lower respiratory tract disease for adults aged at least 60 years.

On June 21, the Advisory Committee on Immunization Practices (ACIP) recommended that people in that age group receive a single dose of RSV vaccine using shared decision-making.

The recommendation for shared decision-making makes the ACIP decision different from routine and risk-based vaccine recommendations. Rather than targeting all in a particular age group or risk group, the decision calls for consideration of a patients’ risk for disease and their characteristics, preferences, and values; the health care professional’s clinical discretion; and performance of the vaccine.

Dr. Melgar and colleagues reported that vaccination with one dose of the GSK or Pfizer RSV vaccines has proved moderately to highly effective in preventing symptomatic RSV-associated lower respiratory tract disease over two consecutive RSV seasons among people aged 60 and older.

The trials that led to approval weren’t powered to gauge efficacy against RSV-associated hospitalization and death. However, the authors wrote, the prevention of lower respiratory tract disease, including medically attended illness, suggests that the shots might prevent considerable morbidity from RSV disease among those aged 60 and older.

Both vaccines were generally well tolerated with a good safety profile. However, six cases of inflammatory neurologic events (including Guillain-Barré Syndrome, acute disseminated encephalomyelitis, and others) were reported in clinical trials after RSV vaccination.

“Whether these events occurred due to chance, or whether RSV vaccination increases the risk for inflammatory neurologic events, is currently unknown,” the authors wrote.

Postmarketing surveillance may help clarify the existence of any potential risk, but until those results are clearer, the CDC researchers said, RSV vaccinations should be targeted to older adults at highest risk for severe RSV and those most likely to benefit from the shots.
 

At higher risk

Some adults with certain medical conditions have a higher risk for RSV-associated hospitalization, according to the report.

Those conditions include chronic obstructive pulmonary disease, asthma, heart failure, coronary artery disease, cerebrovascular disease, diabetes mellitus, and chronic kidney disease.

People who are frail and of advanced age also are at higher risk for RSV hospitalization. That risk increases with age and the highest risk is for people aged at least 75 years.

The researchers added that RSV can cause severe disease in those with compromised immunity, including people who have received hematopoietic stem cell transplants and patients taking immunosuppressive drugs such as those used with solid organ transplants, cancer treatment, or other conditions.

As for when physicians should offer the vaccinations, shots are optimally given before the start of the RSV season.

However, the COVID-19 pandemic interrupted the seasonality and the timing has not yet returned to prepandemic patterns.

For the 2023-24 season, this report states, clinicians should offer RSV vaccination to adults aged at least 60 years using shared clinical decision-making as early as vaccine supply is available and should continue to offer vaccination to eligible adults who remain unvaccinated.

RSV vaccines can be administered with other adult vaccines during the same visit, the authors confirmed.
 

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

Two newly approved respiratory syncytial virus (RSV) vaccines for adults aged 60 years and older may be able to prevent illness in those at risk for severe RSV disease.

Most adult RSV illness occurs among the older age group and results in an estimated 60,000-160,000 hospitalizations and 6,000-10,000 deaths per year among people aged at least 65 years.

Older adults deciding whether to get the vaccines should weigh risks and their own preferences and make the decision in consultation with their clinicians, said authors of a Centers for Disease Control and Prevention report.

Michael Melgar, MD, with the Coronavirus and Other Respiratory Viruses Division at the CDC, was lead author on the report, published in the Morbidity and Mortality Weekly Report.
 

Two new vaccines

In May, the Food and Drug Administration approved the first of two vaccines for preventing RSV lower respiratory tract disease for adults aged at least 60 years.

On June 21, the Advisory Committee on Immunization Practices (ACIP) recommended that people in that age group receive a single dose of RSV vaccine using shared decision-making.

The recommendation for shared decision-making makes the ACIP decision different from routine and risk-based vaccine recommendations. Rather than targeting all in a particular age group or risk group, the decision calls for consideration of a patients’ risk for disease and their characteristics, preferences, and values; the health care professional’s clinical discretion; and performance of the vaccine.

Dr. Melgar and colleagues reported that vaccination with one dose of the GSK or Pfizer RSV vaccines has proved moderately to highly effective in preventing symptomatic RSV-associated lower respiratory tract disease over two consecutive RSV seasons among people aged 60 and older.

The trials that led to approval weren’t powered to gauge efficacy against RSV-associated hospitalization and death. However, the authors wrote, the prevention of lower respiratory tract disease, including medically attended illness, suggests that the shots might prevent considerable morbidity from RSV disease among those aged 60 and older.

Both vaccines were generally well tolerated with a good safety profile. However, six cases of inflammatory neurologic events (including Guillain-Barré Syndrome, acute disseminated encephalomyelitis, and others) were reported in clinical trials after RSV vaccination.

“Whether these events occurred due to chance, or whether RSV vaccination increases the risk for inflammatory neurologic events, is currently unknown,” the authors wrote.

Postmarketing surveillance may help clarify the existence of any potential risk, but until those results are clearer, the CDC researchers said, RSV vaccinations should be targeted to older adults at highest risk for severe RSV and those most likely to benefit from the shots.
 

At higher risk

Some adults with certain medical conditions have a higher risk for RSV-associated hospitalization, according to the report.

Those conditions include chronic obstructive pulmonary disease, asthma, heart failure, coronary artery disease, cerebrovascular disease, diabetes mellitus, and chronic kidney disease.

People who are frail and of advanced age also are at higher risk for RSV hospitalization. That risk increases with age and the highest risk is for people aged at least 75 years.

The researchers added that RSV can cause severe disease in those with compromised immunity, including people who have received hematopoietic stem cell transplants and patients taking immunosuppressive drugs such as those used with solid organ transplants, cancer treatment, or other conditions.

As for when physicians should offer the vaccinations, shots are optimally given before the start of the RSV season.

However, the COVID-19 pandemic interrupted the seasonality and the timing has not yet returned to prepandemic patterns.

For the 2023-24 season, this report states, clinicians should offer RSV vaccination to adults aged at least 60 years using shared clinical decision-making as early as vaccine supply is available and should continue to offer vaccination to eligible adults who remain unvaccinated.

RSV vaccines can be administered with other adult vaccines during the same visit, the authors confirmed.
 

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

The presence of a positive fungal culture in patients with bronchiectasis does not appear to correlate with disease severity or any increased risk of an adverse outcome, according to data pulled from the Bronchiectasis and NTM Registry and presented at the 6th World Bronchiectasis & NTM Conference.

“The question we were asking is whether there is some signal that suggests we need to take care of these patients differently, and the answer is no,” reported Pamela J. McShane, MD, a pulmonologist on the faculty at the University of Texas Health Science Center at Tyler.

When compared for outcome over time, those with a positive fungal culture at initial evaluation did not have more exacerbations, more hospitalizations, or other signs of a more severe disease or more complex course than did those without a positive fungal culture.

When fungal infections are detected in an initial microbiologic evaluation of patients with bronchiectasis or other lung diseases, first-line clinicians generally assume that coverage is needed. Dr. McShane noted that many of the patients referred to her with bronchiectasis and a positive fungal culture were already on an antifungal.

These data are not supportive of treatment in the absence of fungal-related complications. Dr. McShane suggested they even raise questions about the value of culturing beyond bacterial pathogens in the absence of suspicion that fungal organisms are playing a role in symptoms. She cautioned, however, that more studies specifically studying this possibility are needed.
 

Study details

The data were drawn in December 2022 from the U.S.-based Bronchiectasis and NTM Registry, which at that time had 22 participating sites. Of the more than 5,000 patients enrolled, the study looked at 2,230 after several exclusions, such as a diagnosis of allergic bronchopulmonary aspergillosis (ABPA).

Of these 2,230 patients, 949 had a fungal infection at the time of diagnosis and 1,281 did not. Those with a fungal infection were further subdivided into those with an aspergillosis (331 patients) and those with a nonaspergillosis fungal infection (751 patients). The total of these two numbers is greater than the total number of fungal infections because these were not mutually exclusive.

At enrollment into the registry, there were no statistical differences between groups for age. Some statistical differences were observed among groups stratified by race, but Dr. McShane doubted that these were clinically significant with the exception of a potential disparity among Asians that might deserve further analysis.
 

Infection results

Of clinical features evaluated for their association with fungal infection, there was no correlation with either body mass index or history of asthma. Eosinophilia was associated significantly with positive fungal cultures.

Baseline FEV₁ was slightly lower among those with a positive fungal culture even if the difference was highly significant (P = .0006). Again, Dr. McShane questioned the clinical significance of values that varied by only a few percentage points, even though she was willing to acknowledge that higher is always preferable to a lower FEV₁.

In the context of other pathogens, “generally speaking, those with a positive bacterial culture were more likely to have a fungal infection,” Dr. McShane reported, although there was some variation when looking at pathogenicity of the bacteria and other variables.

“Whether this [higher rate of fungal infection] just involves the environment or our antibiotics are driving the opportunity to permit the fungi to exist, we do not have the answer,” she added.

Nontuberculosis mycobacteria (NTM) infection was similarly represented in those with or without a fungal infection, according to Dr. McShane. Noting the high use of antibiotics in an NTM population, Dr. McShane conceded that this challenges the theory that antibiotic use is driving the risk of fungal infection, but these are what the data say.  

Steroid use was associated with a statistically significant risk of fungal infection, but Dr. McShane said it is unclear whether steroid use drives the risk or is an epiphenomenon.

“We looked at this a lot of different ways: oral vs. inhaled and oral vs. inhaled and oral, and it did not make much difference. Generally speaking, the fungal cultures were more likely to be positive in patients on any kind of steroid,” she said.

Finally, with the exception of the slightly lower FEV₁ in patients with fungal infections, Dr. McShane said that there was no discernible relationship between the presence of a fungal infection and severity of bronchiectasis.

Because of this evidence, Dr. McShane concluded that the presence of fungus in the culture of patients with bronchiectasis does not appear to correlate with outcome or severity. Since completing the study, she said she is now using these data to reassure patients who have a positive fungal culture.

While these data do not affect the need to diagnosis fungal infections in patients who are not responding typically to therapy or otherwise have an abnormal course of bronchiectasis, raising suspicion that fungal infection is participating in the disease course, the data provide a basis for questioning whether routine cultures are needed, according to the discussion that followed Dr. McShane’s presentation.
 

Expert opinion

Several of the experts at the presentation provided an opinion. Some reported that they would continue to order fungal cultures on a routine basis, while others said that they now, on the basis of these data, plan to order cultures only at the first visit or when fungal infection is suspected of exacerbating the disease.

Of this latter group, which seemed to be dominant, Juzar Ali, MD, professor of medicine, Louisiana State University, New Orleans, said that he has not been ordering fungal cultures on every visit. Rather, he has been doing so selectively. Examples include those who are on steroids or those with an unusual pattern of exacerbations.

“The value of these data is that they have now provided some data to support this approach,” Dr. Ali said in an interview. Noting that this is the first large study to address this question in a systematic way, he considers this to be a valuable contribution for approaching a common clinical issue.

Dr. McShane reports no relevant financial relationships. Dr. Ali reports a financial relationship with Insmed.
 

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

The presence of a positive fungal culture in patients with bronchiectasis does not appear to correlate with disease severity or any increased risk of an adverse outcome, according to data pulled from the Bronchiectasis and NTM Registry and presented at the 6th World Bronchiectasis & NTM Conference.

“The question we were asking is whether there is some signal that suggests we need to take care of these patients differently, and the answer is no,” reported Pamela J. McShane, MD, a pulmonologist on the faculty at the University of Texas Health Science Center at Tyler.

When compared for outcome over time, those with a positive fungal culture at initial evaluation did not have more exacerbations, more hospitalizations, or other signs of a more severe disease or more complex course than did those without a positive fungal culture.

When fungal infections are detected in an initial microbiologic evaluation of patients with bronchiectasis or other lung diseases, first-line clinicians generally assume that coverage is needed. Dr. McShane noted that many of the patients referred to her with bronchiectasis and a positive fungal culture were already on an antifungal.

These data are not supportive of treatment in the absence of fungal-related complications. Dr. McShane suggested they even raise questions about the value of culturing beyond bacterial pathogens in the absence of suspicion that fungal organisms are playing a role in symptoms. She cautioned, however, that more studies specifically studying this possibility are needed.
 

Study details

The data were drawn in December 2022 from the U.S.-based Bronchiectasis and NTM Registry, which at that time had 22 participating sites. Of the more than 5,000 patients enrolled, the study looked at 2,230 after several exclusions, such as a diagnosis of allergic bronchopulmonary aspergillosis (ABPA).

Of these 2,230 patients, 949 had a fungal infection at the time of diagnosis and 1,281 did not. Those with a fungal infection were further subdivided into those with an aspergillosis (331 patients) and those with a nonaspergillosis fungal infection (751 patients). The total of these two numbers is greater than the total number of fungal infections because these were not mutually exclusive.

At enrollment into the registry, there were no statistical differences between groups for age. Some statistical differences were observed among groups stratified by race, but Dr. McShane doubted that these were clinically significant with the exception of a potential disparity among Asians that might deserve further analysis.
 

Infection results

Of clinical features evaluated for their association with fungal infection, there was no correlation with either body mass index or history of asthma. Eosinophilia was associated significantly with positive fungal cultures.

Baseline FEV₁ was slightly lower among those with a positive fungal culture even if the difference was highly significant (P = .0006). Again, Dr. McShane questioned the clinical significance of values that varied by only a few percentage points, even though she was willing to acknowledge that higher is always preferable to a lower FEV₁.

In the context of other pathogens, “generally speaking, those with a positive bacterial culture were more likely to have a fungal infection,” Dr. McShane reported, although there was some variation when looking at pathogenicity of the bacteria and other variables.

“Whether this [higher rate of fungal infection] just involves the environment or our antibiotics are driving the opportunity to permit the fungi to exist, we do not have the answer,” she added.

Nontuberculosis mycobacteria (NTM) infection was similarly represented in those with or without a fungal infection, according to Dr. McShane. Noting the high use of antibiotics in an NTM population, Dr. McShane conceded that this challenges the theory that antibiotic use is driving the risk of fungal infection, but these are what the data say.  

Steroid use was associated with a statistically significant risk of fungal infection, but Dr. McShane said it is unclear whether steroid use drives the risk or is an epiphenomenon.

“We looked at this a lot of different ways: oral vs. inhaled and oral vs. inhaled and oral, and it did not make much difference. Generally speaking, the fungal cultures were more likely to be positive in patients on any kind of steroid,” she said.

Finally, with the exception of the slightly lower FEV₁ in patients with fungal infections, Dr. McShane said that there was no discernible relationship between the presence of a fungal infection and severity of bronchiectasis.

Because of this evidence, Dr. McShane concluded that the presence of fungus in the culture of patients with bronchiectasis does not appear to correlate with outcome or severity. Since completing the study, she said she is now using these data to reassure patients who have a positive fungal culture.

While these data do not affect the need to diagnosis fungal infections in patients who are not responding typically to therapy or otherwise have an abnormal course of bronchiectasis, raising suspicion that fungal infection is participating in the disease course, the data provide a basis for questioning whether routine cultures are needed, according to the discussion that followed Dr. McShane’s presentation.
 

Expert opinion

Several of the experts at the presentation provided an opinion. Some reported that they would continue to order fungal cultures on a routine basis, while others said that they now, on the basis of these data, plan to order cultures only at the first visit or when fungal infection is suspected of exacerbating the disease.

Of this latter group, which seemed to be dominant, Juzar Ali, MD, professor of medicine, Louisiana State University, New Orleans, said that he has not been ordering fungal cultures on every visit. Rather, he has been doing so selectively. Examples include those who are on steroids or those with an unusual pattern of exacerbations.

“The value of these data is that they have now provided some data to support this approach,” Dr. Ali said in an interview. Noting that this is the first large study to address this question in a systematic way, he considers this to be a valuable contribution for approaching a common clinical issue.

Dr. McShane reports no relevant financial relationships. Dr. Ali reports a financial relationship with Insmed.
 

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

The presence of a positive fungal culture in patients with bronchiectasis does not appear to correlate with disease severity or any increased risk of an adverse outcome, according to data pulled from the Bronchiectasis and NTM Registry and presented at the 6th World Bronchiectasis & NTM Conference.

“The question we were asking is whether there is some signal that suggests we need to take care of these patients differently, and the answer is no,” reported Pamela J. McShane, MD, a pulmonologist on the faculty at the University of Texas Health Science Center at Tyler.

When compared for outcome over time, those with a positive fungal culture at initial evaluation did not have more exacerbations, more hospitalizations, or other signs of a more severe disease or more complex course than did those without a positive fungal culture.

When fungal infections are detected in an initial microbiologic evaluation of patients with bronchiectasis or other lung diseases, first-line clinicians generally assume that coverage is needed. Dr. McShane noted that many of the patients referred to her with bronchiectasis and a positive fungal culture were already on an antifungal.

These data are not supportive of treatment in the absence of fungal-related complications. Dr. McShane suggested they even raise questions about the value of culturing beyond bacterial pathogens in the absence of suspicion that fungal organisms are playing a role in symptoms. She cautioned, however, that more studies specifically studying this possibility are needed.
 

Study details

The data were drawn in December 2022 from the U.S.-based Bronchiectasis and NTM Registry, which at that time had 22 participating sites. Of the more than 5,000 patients enrolled, the study looked at 2,230 after several exclusions, such as a diagnosis of allergic bronchopulmonary aspergillosis (ABPA).

Of these 2,230 patients, 949 had a fungal infection at the time of diagnosis and 1,281 did not. Those with a fungal infection were further subdivided into those with an aspergillosis (331 patients) and those with a nonaspergillosis fungal infection (751 patients). The total of these two numbers is greater than the total number of fungal infections because these were not mutually exclusive.

At enrollment into the registry, there were no statistical differences between groups for age. Some statistical differences were observed among groups stratified by race, but Dr. McShane doubted that these were clinically significant with the exception of a potential disparity among Asians that might deserve further analysis.
 

Infection results

Of clinical features evaluated for their association with fungal infection, there was no correlation with either body mass index or history of asthma. Eosinophilia was associated significantly with positive fungal cultures.

Baseline FEV₁ was slightly lower among those with a positive fungal culture even if the difference was highly significant (P = .0006). Again, Dr. McShane questioned the clinical significance of values that varied by only a few percentage points, even though she was willing to acknowledge that higher is always preferable to a lower FEV₁.

In the context of other pathogens, “generally speaking, those with a positive bacterial culture were more likely to have a fungal infection,” Dr. McShane reported, although there was some variation when looking at pathogenicity of the bacteria and other variables.

“Whether this [higher rate of fungal infection] just involves the environment or our antibiotics are driving the opportunity to permit the fungi to exist, we do not have the answer,” she added.

Nontuberculosis mycobacteria (NTM) infection was similarly represented in those with or without a fungal infection, according to Dr. McShane. Noting the high use of antibiotics in an NTM population, Dr. McShane conceded that this challenges the theory that antibiotic use is driving the risk of fungal infection, but these are what the data say.  

Steroid use was associated with a statistically significant risk of fungal infection, but Dr. McShane said it is unclear whether steroid use drives the risk or is an epiphenomenon.

“We looked at this a lot of different ways: oral vs. inhaled and oral vs. inhaled and oral, and it did not make much difference. Generally speaking, the fungal cultures were more likely to be positive in patients on any kind of steroid,” she said.

Finally, with the exception of the slightly lower FEV₁ in patients with fungal infections, Dr. McShane said that there was no discernible relationship between the presence of a fungal infection and severity of bronchiectasis.

Because of this evidence, Dr. McShane concluded that the presence of fungus in the culture of patients with bronchiectasis does not appear to correlate with outcome or severity. Since completing the study, she said she is now using these data to reassure patients who have a positive fungal culture.

While these data do not affect the need to diagnosis fungal infections in patients who are not responding typically to therapy or otherwise have an abnormal course of bronchiectasis, raising suspicion that fungal infection is participating in the disease course, the data provide a basis for questioning whether routine cultures are needed, according to the discussion that followed Dr. McShane’s presentation.
 

Expert opinion

Several of the experts at the presentation provided an opinion. Some reported that they would continue to order fungal cultures on a routine basis, while others said that they now, on the basis of these data, plan to order cultures only at the first visit or when fungal infection is suspected of exacerbating the disease.

Of this latter group, which seemed to be dominant, Juzar Ali, MD, professor of medicine, Louisiana State University, New Orleans, said that he has not been ordering fungal cultures on every visit. Rather, he has been doing so selectively. Examples include those who are on steroids or those with an unusual pattern of exacerbations.

“The value of these data is that they have now provided some data to support this approach,” Dr. Ali said in an interview. Noting that this is the first large study to address this question in a systematic way, he considers this to be a valuable contribution for approaching a common clinical issue.

Dr. McShane reports no relevant financial relationships. Dr. Ali reports a financial relationship with Insmed.
 

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