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Early procalcitonin testing reduced ICU costs for sepsis patients
Procalcitonin (PCT) testing on the first day of ICU admission for adult patients with sepsis is associated with reduced length of stay, less antibiotic exposure, and reduced hospital and pharmacy costs, Robert A. Balk, MD, and his associates reported.
The researchers analyzed data on more than 15 million patients in the Premier Research Database; of those, more than 730,000 had a potential diagnosis of sepsis, systemic inflammatory response syndrome (SIRS), septicemia, or a shock-related diagnosis on ICU admission or discharge (CHEST. 2017;151[1]:23-33).
After propensity matching to reduce potential bias, a total of 33,569 patients who had received PCT testing on ICU day 1 were identified; a control group of 98,543 non-PCT tested patients were identified as well. Hospital costs were $2,759 lower for PCT-tested patients ($30,454 vs. $33,213), ICU costs were $1,310 lower ($20,155 vs. $21,465), and pharmacy costs were $331 lower ($4,238 vs. $4,568). PCT-tested patients also were more commonly discharged to home (44.1% vs. 41.3%).
The PCT-tested patients had less total antibiotic exposure, (16.2 days vs. 16.9 days) but higher laboratory costs, according to Dr. Balk, director of the division of pulmonary and critical care medicine at Rush Medical College, Chicago, and his colleagues. Laboratory costs of the PCT-tested patients were $81 greater ($1,807 vs. $1,726).
While PCT testing is cleared by the Food and Drug Administration to assist in identifying patients who are highly likely to develop sepsis, there is no approved sepsis test, Dr. Balk and his colleagues noted.
“This study is important in the validation of the ability of PCT testing to favorably impact the outcome of critically ill patients when used according to the FDA cleared guidelines,” the investigators said. “The cost savings were real and consequential, exceeding the potential increased costs of laboratory testing associated with PCT testing on ICU admission.”
All-patient analysis showed a statistically significant, but slightly increased (0.7%) risk of mortality in PCT-tested patients; however, the finding was not seen in an enhanced risk-adjusted analysis of 96% of patients, the investigators pointed out. This finding is consistent with other large prospective studies showing no difference in mortality or other clinical outcomes using PCT guidances.
PCT testing has not been uniformly adopted despite its inclusion in the 2012 Surviving Sepsis Guidelines, in part, due to cost. The lack of a “gold standard” sepsis test has resulted in diagnostic dilemmas, delayed treatment, and poor outcomes, Dr. Balk and colleagues noted.
Because patients were not randomized to PCT testing or non-PCT testing groups, additional variables could have over- or underestimated the effect of PCT on patient outcomes, the researchers added.
Dr. Balk has received advisory board fees from bioMerieux USA, Roche Diagnostics, and ThermoFisher Scientific; Zhun Cao, PhD, Craig Lipkin, MS, and Scott B. Robinson MA, MPH, are employees of Premier Research Services, in Charlotte. Samuel Bozzette is an employee of bioMerieux, which provided funding for the study.
The significant findings of Balk et al. suggest that “real world” evidence may support procalcitonin as an effective tool to improve antibiotic management and reduce costs of health care for critically ill patients. Data from public databases and patient registries can play key roles in evaluating biomarkers, since physicians preparing randomized trials may behave differently than in typical care settings.
Results of the recent randomized [Simplified Acute Physiology Score] trial in connection with real-life data reported by Dr. Balk and colleagues are convincing and should lead physicians to more widespread use of PCT protocols for management of patients in the critical care settings.
The study findings also add the U.S. experience to the knowledge base as most of the interventional research has been done in Europe and Asia.
Given the promising results from the randomized trials, it is important to know how PCT impacts the clinical management of patients in real-world settings. Such information can be used to further broaden and expand the findings from the randomized trials to usual care.
Philipp Schuetz, MD, MPH, of the University of Basel, Switzerland, receives research support from Thermo Fisher and bioMerieux, which make PCT tests. Peter M. Wahl, ScD, is a full-time employee of Covance Inc., of Princeton, N.J., which makes diagnostic tests and owns clinical laboratories. Their comments were made in an editorial accompanying Dr. Balk’s report (Chest. 2017;151[1]:6-8. doi:10.1016/j.chest.2016.07.014).
The significant findings of Balk et al. suggest that “real world” evidence may support procalcitonin as an effective tool to improve antibiotic management and reduce costs of health care for critically ill patients. Data from public databases and patient registries can play key roles in evaluating biomarkers, since physicians preparing randomized trials may behave differently than in typical care settings.
Results of the recent randomized [Simplified Acute Physiology Score] trial in connection with real-life data reported by Dr. Balk and colleagues are convincing and should lead physicians to more widespread use of PCT protocols for management of patients in the critical care settings.
The study findings also add the U.S. experience to the knowledge base as most of the interventional research has been done in Europe and Asia.
Given the promising results from the randomized trials, it is important to know how PCT impacts the clinical management of patients in real-world settings. Such information can be used to further broaden and expand the findings from the randomized trials to usual care.
Philipp Schuetz, MD, MPH, of the University of Basel, Switzerland, receives research support from Thermo Fisher and bioMerieux, which make PCT tests. Peter M. Wahl, ScD, is a full-time employee of Covance Inc., of Princeton, N.J., which makes diagnostic tests and owns clinical laboratories. Their comments were made in an editorial accompanying Dr. Balk’s report (Chest. 2017;151[1]:6-8. doi:10.1016/j.chest.2016.07.014).
The significant findings of Balk et al. suggest that “real world” evidence may support procalcitonin as an effective tool to improve antibiotic management and reduce costs of health care for critically ill patients. Data from public databases and patient registries can play key roles in evaluating biomarkers, since physicians preparing randomized trials may behave differently than in typical care settings.
Results of the recent randomized [Simplified Acute Physiology Score] trial in connection with real-life data reported by Dr. Balk and colleagues are convincing and should lead physicians to more widespread use of PCT protocols for management of patients in the critical care settings.
The study findings also add the U.S. experience to the knowledge base as most of the interventional research has been done in Europe and Asia.
Given the promising results from the randomized trials, it is important to know how PCT impacts the clinical management of patients in real-world settings. Such information can be used to further broaden and expand the findings from the randomized trials to usual care.
Philipp Schuetz, MD, MPH, of the University of Basel, Switzerland, receives research support from Thermo Fisher and bioMerieux, which make PCT tests. Peter M. Wahl, ScD, is a full-time employee of Covance Inc., of Princeton, N.J., which makes diagnostic tests and owns clinical laboratories. Their comments were made in an editorial accompanying Dr. Balk’s report (Chest. 2017;151[1]:6-8. doi:10.1016/j.chest.2016.07.014).
Procalcitonin (PCT) testing on the first day of ICU admission for adult patients with sepsis is associated with reduced length of stay, less antibiotic exposure, and reduced hospital and pharmacy costs, Robert A. Balk, MD, and his associates reported.
The researchers analyzed data on more than 15 million patients in the Premier Research Database; of those, more than 730,000 had a potential diagnosis of sepsis, systemic inflammatory response syndrome (SIRS), septicemia, or a shock-related diagnosis on ICU admission or discharge (CHEST. 2017;151[1]:23-33).
After propensity matching to reduce potential bias, a total of 33,569 patients who had received PCT testing on ICU day 1 were identified; a control group of 98,543 non-PCT tested patients were identified as well. Hospital costs were $2,759 lower for PCT-tested patients ($30,454 vs. $33,213), ICU costs were $1,310 lower ($20,155 vs. $21,465), and pharmacy costs were $331 lower ($4,238 vs. $4,568). PCT-tested patients also were more commonly discharged to home (44.1% vs. 41.3%).
The PCT-tested patients had less total antibiotic exposure, (16.2 days vs. 16.9 days) but higher laboratory costs, according to Dr. Balk, director of the division of pulmonary and critical care medicine at Rush Medical College, Chicago, and his colleagues. Laboratory costs of the PCT-tested patients were $81 greater ($1,807 vs. $1,726).
While PCT testing is cleared by the Food and Drug Administration to assist in identifying patients who are highly likely to develop sepsis, there is no approved sepsis test, Dr. Balk and his colleagues noted.
“This study is important in the validation of the ability of PCT testing to favorably impact the outcome of critically ill patients when used according to the FDA cleared guidelines,” the investigators said. “The cost savings were real and consequential, exceeding the potential increased costs of laboratory testing associated with PCT testing on ICU admission.”
All-patient analysis showed a statistically significant, but slightly increased (0.7%) risk of mortality in PCT-tested patients; however, the finding was not seen in an enhanced risk-adjusted analysis of 96% of patients, the investigators pointed out. This finding is consistent with other large prospective studies showing no difference in mortality or other clinical outcomes using PCT guidances.
PCT testing has not been uniformly adopted despite its inclusion in the 2012 Surviving Sepsis Guidelines, in part, due to cost. The lack of a “gold standard” sepsis test has resulted in diagnostic dilemmas, delayed treatment, and poor outcomes, Dr. Balk and colleagues noted.
Because patients were not randomized to PCT testing or non-PCT testing groups, additional variables could have over- or underestimated the effect of PCT on patient outcomes, the researchers added.
Dr. Balk has received advisory board fees from bioMerieux USA, Roche Diagnostics, and ThermoFisher Scientific; Zhun Cao, PhD, Craig Lipkin, MS, and Scott B. Robinson MA, MPH, are employees of Premier Research Services, in Charlotte. Samuel Bozzette is an employee of bioMerieux, which provided funding for the study.
Procalcitonin (PCT) testing on the first day of ICU admission for adult patients with sepsis is associated with reduced length of stay, less antibiotic exposure, and reduced hospital and pharmacy costs, Robert A. Balk, MD, and his associates reported.
The researchers analyzed data on more than 15 million patients in the Premier Research Database; of those, more than 730,000 had a potential diagnosis of sepsis, systemic inflammatory response syndrome (SIRS), septicemia, or a shock-related diagnosis on ICU admission or discharge (CHEST. 2017;151[1]:23-33).
After propensity matching to reduce potential bias, a total of 33,569 patients who had received PCT testing on ICU day 1 were identified; a control group of 98,543 non-PCT tested patients were identified as well. Hospital costs were $2,759 lower for PCT-tested patients ($30,454 vs. $33,213), ICU costs were $1,310 lower ($20,155 vs. $21,465), and pharmacy costs were $331 lower ($4,238 vs. $4,568). PCT-tested patients also were more commonly discharged to home (44.1% vs. 41.3%).
The PCT-tested patients had less total antibiotic exposure, (16.2 days vs. 16.9 days) but higher laboratory costs, according to Dr. Balk, director of the division of pulmonary and critical care medicine at Rush Medical College, Chicago, and his colleagues. Laboratory costs of the PCT-tested patients were $81 greater ($1,807 vs. $1,726).
While PCT testing is cleared by the Food and Drug Administration to assist in identifying patients who are highly likely to develop sepsis, there is no approved sepsis test, Dr. Balk and his colleagues noted.
“This study is important in the validation of the ability of PCT testing to favorably impact the outcome of critically ill patients when used according to the FDA cleared guidelines,” the investigators said. “The cost savings were real and consequential, exceeding the potential increased costs of laboratory testing associated with PCT testing on ICU admission.”
All-patient analysis showed a statistically significant, but slightly increased (0.7%) risk of mortality in PCT-tested patients; however, the finding was not seen in an enhanced risk-adjusted analysis of 96% of patients, the investigators pointed out. This finding is consistent with other large prospective studies showing no difference in mortality or other clinical outcomes using PCT guidances.
PCT testing has not been uniformly adopted despite its inclusion in the 2012 Surviving Sepsis Guidelines, in part, due to cost. The lack of a “gold standard” sepsis test has resulted in diagnostic dilemmas, delayed treatment, and poor outcomes, Dr. Balk and colleagues noted.
Because patients were not randomized to PCT testing or non-PCT testing groups, additional variables could have over- or underestimated the effect of PCT on patient outcomes, the researchers added.
Dr. Balk has received advisory board fees from bioMerieux USA, Roche Diagnostics, and ThermoFisher Scientific; Zhun Cao, PhD, Craig Lipkin, MS, and Scott B. Robinson MA, MPH, are employees of Premier Research Services, in Charlotte. Samuel Bozzette is an employee of bioMerieux, which provided funding for the study.
FROM CHEST
Key clinical point: Procalcitonin (PCT) testing on the first day of ICU admission for critically ill adults with sepsis is associated with reduced ICU length of stay and reduced hospital and pharmacy costs.
Major finding: Total hospital and ICU costs were $2,759 and $1,310 less, respectively, for PCT managed patients, while inpatient mortality for patients who received PCT was 19% vs. 18.3% for those who did not receive PCT.
Data source: A retrospective study of data on more than 730,000 adult patients who had a potential sepsis, SIRS, septicemia, or shock-related diagnosis on admission or discharge, and were treated in the ICU.
Disclosures: Dr. Balk has received advisory board fees from bioMerieux USA, Roche Diagnostics, and Thermo Fisher Scientific; Zhun Cao, PhD, Craig Lipkin, and Scott B. Robinson are employees of Premier Research Services. Samuel Bozzette is an employee of bioMerieux, which provided funding for the study.
Survey: Commonly delayed PCOS diagnosis suggests room for clinical improvement
Diagnosis of polycystic ovarian syndrome (PCOS) is commonly delayed, and this situation is a source of frustration for affected women, judging from findings from a survey of patients that was released early by the Journal of Clinical Endocrinology & Metabolism.
PCOS is not a difficult diagnosis to make. The disorder affected between 9% and 18% of women of reproductive age, and diagnosis requires the presence of two of the following three features: polycystic ovaries on ultrasound, biochemical/clinical hyperandrogenism, and/or oligomenorrhea/amenorrhea. Major gaps in early diagnosis of PCOS reflect the need for education and support for physicians and patients as “clear opportunities for improving patient experience,” noted Melanie Gibson-Helm, PhD, of Monash University, Melbourne, and her associates (J Clin Endo Metab. 2016. Dec 1. doi: 10.1210/jc.2016-2963).
A total of 1,385 women with a reported diagnosis of PCOS completed the survey, the largest international assessment of this issue. Participants were recruited via support group websites during 2015-2016. Most (64.8%) were aged 18-35 years of age at the time of the survey; 53% lived in North America, 42.2% in Europe, and 4.9% in other places.
About 34% reported waiting more than 2 years for a diagnosis, and 47.1% said they had seen more than three health care professionals before a diagnosis was established. More than half (52.5%) reported they didn’t receive any information about long-term PCOS complications or emotional counseling or support. About 35.2% said they were satisfied with their diagnosis experience, and 15.6% were satisfied with the information they received.
“The bottom line it’s easy to diagnose. There’s no reason why primary care providers and general practice physicians shouldn’t be able to evaluate those women,” she said. “These women are incredibly underserved.”
Amenorrhea and hirsutism should raise a red flag among physicians, coauthor Helena Teede, MBBS, PhD, said in an interview. Dr. Teede, president-elect of the Endocrine Society of Australia, is also on the faculty of Monash University.
The survey finding confirms a previous Australian study that noted PCOS diagnosis is often delayed, includes the involvement of a series of health professionals, and also leaves many women with unmet information needs.
For researchers, the findings were no surprise and reaffirmed what they said are inadequate responses to the disease from practitioners, with far-reaching changes needed, from improvements in diagnostic procedures to possible name changes for the condition to increase its understanding.
The study findings are intended to buttress an international initiative to improve diagnoses and education to not only meet women’s needs but also, it said, to “optimize early engagement with evidence-based management.”
This research received no direct funding. Dr Gibson-Helm and Dr. Teede are National Health & Medical Research Council Research Fellows; otherwise the authors have nothing to disclose.
Diagnosis of polycystic ovarian syndrome (PCOS) is commonly delayed, and this situation is a source of frustration for affected women, judging from findings from a survey of patients that was released early by the Journal of Clinical Endocrinology & Metabolism.
PCOS is not a difficult diagnosis to make. The disorder affected between 9% and 18% of women of reproductive age, and diagnosis requires the presence of two of the following three features: polycystic ovaries on ultrasound, biochemical/clinical hyperandrogenism, and/or oligomenorrhea/amenorrhea. Major gaps in early diagnosis of PCOS reflect the need for education and support for physicians and patients as “clear opportunities for improving patient experience,” noted Melanie Gibson-Helm, PhD, of Monash University, Melbourne, and her associates (J Clin Endo Metab. 2016. Dec 1. doi: 10.1210/jc.2016-2963).
A total of 1,385 women with a reported diagnosis of PCOS completed the survey, the largest international assessment of this issue. Participants were recruited via support group websites during 2015-2016. Most (64.8%) were aged 18-35 years of age at the time of the survey; 53% lived in North America, 42.2% in Europe, and 4.9% in other places.
About 34% reported waiting more than 2 years for a diagnosis, and 47.1% said they had seen more than three health care professionals before a diagnosis was established. More than half (52.5%) reported they didn’t receive any information about long-term PCOS complications or emotional counseling or support. About 35.2% said they were satisfied with their diagnosis experience, and 15.6% were satisfied with the information they received.
“The bottom line it’s easy to diagnose. There’s no reason why primary care providers and general practice physicians shouldn’t be able to evaluate those women,” she said. “These women are incredibly underserved.”
Amenorrhea and hirsutism should raise a red flag among physicians, coauthor Helena Teede, MBBS, PhD, said in an interview. Dr. Teede, president-elect of the Endocrine Society of Australia, is also on the faculty of Monash University.
The survey finding confirms a previous Australian study that noted PCOS diagnosis is often delayed, includes the involvement of a series of health professionals, and also leaves many women with unmet information needs.
For researchers, the findings were no surprise and reaffirmed what they said are inadequate responses to the disease from practitioners, with far-reaching changes needed, from improvements in diagnostic procedures to possible name changes for the condition to increase its understanding.
The study findings are intended to buttress an international initiative to improve diagnoses and education to not only meet women’s needs but also, it said, to “optimize early engagement with evidence-based management.”
This research received no direct funding. Dr Gibson-Helm and Dr. Teede are National Health & Medical Research Council Research Fellows; otherwise the authors have nothing to disclose.
Diagnosis of polycystic ovarian syndrome (PCOS) is commonly delayed, and this situation is a source of frustration for affected women, judging from findings from a survey of patients that was released early by the Journal of Clinical Endocrinology & Metabolism.
PCOS is not a difficult diagnosis to make. The disorder affected between 9% and 18% of women of reproductive age, and diagnosis requires the presence of two of the following three features: polycystic ovaries on ultrasound, biochemical/clinical hyperandrogenism, and/or oligomenorrhea/amenorrhea. Major gaps in early diagnosis of PCOS reflect the need for education and support for physicians and patients as “clear opportunities for improving patient experience,” noted Melanie Gibson-Helm, PhD, of Monash University, Melbourne, and her associates (J Clin Endo Metab. 2016. Dec 1. doi: 10.1210/jc.2016-2963).
A total of 1,385 women with a reported diagnosis of PCOS completed the survey, the largest international assessment of this issue. Participants were recruited via support group websites during 2015-2016. Most (64.8%) were aged 18-35 years of age at the time of the survey; 53% lived in North America, 42.2% in Europe, and 4.9% in other places.
About 34% reported waiting more than 2 years for a diagnosis, and 47.1% said they had seen more than three health care professionals before a diagnosis was established. More than half (52.5%) reported they didn’t receive any information about long-term PCOS complications or emotional counseling or support. About 35.2% said they were satisfied with their diagnosis experience, and 15.6% were satisfied with the information they received.
“The bottom line it’s easy to diagnose. There’s no reason why primary care providers and general practice physicians shouldn’t be able to evaluate those women,” she said. “These women are incredibly underserved.”
Amenorrhea and hirsutism should raise a red flag among physicians, coauthor Helena Teede, MBBS, PhD, said in an interview. Dr. Teede, president-elect of the Endocrine Society of Australia, is also on the faculty of Monash University.
The survey finding confirms a previous Australian study that noted PCOS diagnosis is often delayed, includes the involvement of a series of health professionals, and also leaves many women with unmet information needs.
For researchers, the findings were no surprise and reaffirmed what they said are inadequate responses to the disease from practitioners, with far-reaching changes needed, from improvements in diagnostic procedures to possible name changes for the condition to increase its understanding.
The study findings are intended to buttress an international initiative to improve diagnoses and education to not only meet women’s needs but also, it said, to “optimize early engagement with evidence-based management.”
This research received no direct funding. Dr Gibson-Helm and Dr. Teede are National Health & Medical Research Council Research Fellows; otherwise the authors have nothing to disclose.