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Sleep Apnea Found in 57% of Veterans With PTSD
Obstructive sleep apnea syndrome (OSAS) was diagnosed in more than half of 200 active duty service members with combat-related post-traumatic stress disorder (PTSD) who were studied at Walter Reed Army Medical Center in Washington.
Compared with age-matched peers with just one of these disorders, the service members with PTSD and OSAS had poorer somnolence and sleep-related quality of life and were less adherent and responsive to positive airway pressure therapy.
The findings “highlight the need for a high index of suspicion and a comprehensive approach to identifying and treating sleep-disordered breathing in these patients,” Dr. Christopher J. Lettieri of the Uniformed Services University in Bethesda, Md., and his associates wrote (Chest. 2016 Feb;149[2]:483-90). “Given the prevalence of OSAS in patients with PTSD and its adverse impact on symptoms and adherence, early identification may improve outcomes.”
In the observational cohort study, 200 consecutive active duty service members who were diagnosed with PTSD as part of post-deployment screening underwent sleep evaluations regardless of whether there was clinical suspicion of sleep-disordered breathing. More than half – about 57% – were diagnosed with OSAS. Almost 60% of the study group had mild traumatic brain injury, which has been connected in prior research to obstructive sleep apnea, and many had comorbid insomnia. Those who were diagnosed with OSAS were older and had higher BMIs than those not found to have OSAS.
All 200 patients were compared with 50 consecutive age-matched control patients who had OSAS but had not been deployed and did not have PTSD, as well as with 50 age-matched service members without prior deployment or either of the two disorders. All of the patients diagnosed with OSAS were prescribed positive airway pressure (PAP) therapy and evaluated after a month.
Sleep quality was poor in the majority of patients with PTSD, and OSAS and PTSD were both independently associated with increased daytime sleepiness and lower quality-of-life index scores. However, patients with both conditions fared significantly worse, particularly with respect to quality of life as measured by the Functional Outcomes of Sleep Questionnaire (FOSQ).
FOSQ scores were abnormal at baseline in 60% of those with PTSD and OSAS, 43% with PTSD alone, 24% with OSAS alone, and 7% of those with neither condition.
Service members with both conditions also were less likely to adhere to therapy; 30% regularly used continuous PAP therapy, compared with 55% of those who had OSAS alone.
And while continuous PAP therapy improved daytime sleepiness and quality of life in patients with both PTSD and OSAS, the degree of improvement was less than that experienced by those with OSAS alone. PTSD “represents an independent barrier to the effective treatment of OSAS and should prompt multipronged and individualized care,” they wrote.
The researchers reported having no financial disclosures.
Obstructive sleep apnea syndrome (OSAS) was diagnosed in more than half of 200 active duty service members with combat-related post-traumatic stress disorder (PTSD) who were studied at Walter Reed Army Medical Center in Washington.
Compared with age-matched peers with just one of these disorders, the service members with PTSD and OSAS had poorer somnolence and sleep-related quality of life and were less adherent and responsive to positive airway pressure therapy.
The findings “highlight the need for a high index of suspicion and a comprehensive approach to identifying and treating sleep-disordered breathing in these patients,” Dr. Christopher J. Lettieri of the Uniformed Services University in Bethesda, Md., and his associates wrote (Chest. 2016 Feb;149[2]:483-90). “Given the prevalence of OSAS in patients with PTSD and its adverse impact on symptoms and adherence, early identification may improve outcomes.”
In the observational cohort study, 200 consecutive active duty service members who were diagnosed with PTSD as part of post-deployment screening underwent sleep evaluations regardless of whether there was clinical suspicion of sleep-disordered breathing. More than half – about 57% – were diagnosed with OSAS. Almost 60% of the study group had mild traumatic brain injury, which has been connected in prior research to obstructive sleep apnea, and many had comorbid insomnia. Those who were diagnosed with OSAS were older and had higher BMIs than those not found to have OSAS.
All 200 patients were compared with 50 consecutive age-matched control patients who had OSAS but had not been deployed and did not have PTSD, as well as with 50 age-matched service members without prior deployment or either of the two disorders. All of the patients diagnosed with OSAS were prescribed positive airway pressure (PAP) therapy and evaluated after a month.
Sleep quality was poor in the majority of patients with PTSD, and OSAS and PTSD were both independently associated with increased daytime sleepiness and lower quality-of-life index scores. However, patients with both conditions fared significantly worse, particularly with respect to quality of life as measured by the Functional Outcomes of Sleep Questionnaire (FOSQ).
FOSQ scores were abnormal at baseline in 60% of those with PTSD and OSAS, 43% with PTSD alone, 24% with OSAS alone, and 7% of those with neither condition.
Service members with both conditions also were less likely to adhere to therapy; 30% regularly used continuous PAP therapy, compared with 55% of those who had OSAS alone.
And while continuous PAP therapy improved daytime sleepiness and quality of life in patients with both PTSD and OSAS, the degree of improvement was less than that experienced by those with OSAS alone. PTSD “represents an independent barrier to the effective treatment of OSAS and should prompt multipronged and individualized care,” they wrote.
The researchers reported having no financial disclosures.
Obstructive sleep apnea syndrome (OSAS) was diagnosed in more than half of 200 active duty service members with combat-related post-traumatic stress disorder (PTSD) who were studied at Walter Reed Army Medical Center in Washington.
Compared with age-matched peers with just one of these disorders, the service members with PTSD and OSAS had poorer somnolence and sleep-related quality of life and were less adherent and responsive to positive airway pressure therapy.
The findings “highlight the need for a high index of suspicion and a comprehensive approach to identifying and treating sleep-disordered breathing in these patients,” Dr. Christopher J. Lettieri of the Uniformed Services University in Bethesda, Md., and his associates wrote (Chest. 2016 Feb;149[2]:483-90). “Given the prevalence of OSAS in patients with PTSD and its adverse impact on symptoms and adherence, early identification may improve outcomes.”
In the observational cohort study, 200 consecutive active duty service members who were diagnosed with PTSD as part of post-deployment screening underwent sleep evaluations regardless of whether there was clinical suspicion of sleep-disordered breathing. More than half – about 57% – were diagnosed with OSAS. Almost 60% of the study group had mild traumatic brain injury, which has been connected in prior research to obstructive sleep apnea, and many had comorbid insomnia. Those who were diagnosed with OSAS were older and had higher BMIs than those not found to have OSAS.
All 200 patients were compared with 50 consecutive age-matched control patients who had OSAS but had not been deployed and did not have PTSD, as well as with 50 age-matched service members without prior deployment or either of the two disorders. All of the patients diagnosed with OSAS were prescribed positive airway pressure (PAP) therapy and evaluated after a month.
Sleep quality was poor in the majority of patients with PTSD, and OSAS and PTSD were both independently associated with increased daytime sleepiness and lower quality-of-life index scores. However, patients with both conditions fared significantly worse, particularly with respect to quality of life as measured by the Functional Outcomes of Sleep Questionnaire (FOSQ).
FOSQ scores were abnormal at baseline in 60% of those with PTSD and OSAS, 43% with PTSD alone, 24% with OSAS alone, and 7% of those with neither condition.
Service members with both conditions also were less likely to adhere to therapy; 30% regularly used continuous PAP therapy, compared with 55% of those who had OSAS alone.
And while continuous PAP therapy improved daytime sleepiness and quality of life in patients with both PTSD and OSAS, the degree of improvement was less than that experienced by those with OSAS alone. PTSD “represents an independent barrier to the effective treatment of OSAS and should prompt multipronged and individualized care,” they wrote.
The researchers reported having no financial disclosures.
FROM CHEST
Sleep apnea found in 57% of veterans with PTSD
Obstructive sleep apnea syndrome (OSAS) was diagnosed in more than half of 200 active duty service members with combat-related post-traumatic stress disorder (PTSD) who were studied at Walter Reed Army Medical Center in Washington.
Compared with age-matched peers with just one of these disorders, the service members with PTSD and OSAS had poorer somnolence and sleep-related quality of life and were less adherent and responsive to positive airway pressure therapy.
The findings “highlight the need for a high index of suspicion and a comprehensive approach to identifying and treating sleep-disordered breathing in these patients,” Dr. Christopher J. Lettieri of the Uniformed Services University in Bethesda, Md., and his associates wrote (Chest. 2016 Feb;149[2]:483-90). “Given the prevalence of OSAS in patients with PTSD and its adverse impact on symptoms and adherence, early identification may improve outcomes.”
In the observational cohort study, 200 consecutive active duty service members who were diagnosed with PTSD as part of post-deployment screening underwent sleep evaluations regardless of whether there was clinical suspicion of sleep-disordered breathing. More than half – about 57% – were diagnosed with OSAS. Almost 60% of the study group had mild traumatic brain injury, which has been connected in prior research to obstructive sleep apnea, and many had comorbid insomnia. Those who were diagnosed with OSAS were older and had higher BMIs than those not found to have OSAS.
All 200 patients were compared with 50 consecutive age-matched control patients who had OSAS but had not been deployed and did not have PTSD, as well as with 50 age-matched service members without prior deployment or either of the two disorders. All of the patients diagnosed with OSAS were prescribed positive airway pressure (PAP) therapy and evaluated after a month.
Sleep quality was poor in the majority of patients with PTSD, and OSAS and PTSD were both independently associated with increased daytime sleepiness and lower quality-of-life index scores. However, patients with both conditions fared significantly worse, particularly with respect to quality of life as measured by the Functional Outcomes of Sleep Questionnaire (FOSQ).
FOSQ scores were abnormal at baseline in 60% of those with PTSD and OSAS, 43% with PTSD alone, 24% with OSAS alone, and 7% of those with neither condition.
Service members with both conditions also were less likely to adhere to therapy; 30% regularly used continuous PAP therapy, compared with 55% of those who had OSAS alone.
And while continuous PAP therapy improved daytime sleepiness and quality of life in patients with both PTSD and OSAS, the degree of improvement was less than that experienced by those with OSAS alone. PTSD “represents an independent barrier to the effective treatment of OSAS and should prompt multipronged and individualized care,” they wrote.
The researchers reported having no financial disclosures.
Obstructive sleep apnea syndrome (OSAS) was diagnosed in more than half of 200 active duty service members with combat-related post-traumatic stress disorder (PTSD) who were studied at Walter Reed Army Medical Center in Washington.
Compared with age-matched peers with just one of these disorders, the service members with PTSD and OSAS had poorer somnolence and sleep-related quality of life and were less adherent and responsive to positive airway pressure therapy.
The findings “highlight the need for a high index of suspicion and a comprehensive approach to identifying and treating sleep-disordered breathing in these patients,” Dr. Christopher J. Lettieri of the Uniformed Services University in Bethesda, Md., and his associates wrote (Chest. 2016 Feb;149[2]:483-90). “Given the prevalence of OSAS in patients with PTSD and its adverse impact on symptoms and adherence, early identification may improve outcomes.”
In the observational cohort study, 200 consecutive active duty service members who were diagnosed with PTSD as part of post-deployment screening underwent sleep evaluations regardless of whether there was clinical suspicion of sleep-disordered breathing. More than half – about 57% – were diagnosed with OSAS. Almost 60% of the study group had mild traumatic brain injury, which has been connected in prior research to obstructive sleep apnea, and many had comorbid insomnia. Those who were diagnosed with OSAS were older and had higher BMIs than those not found to have OSAS.
All 200 patients were compared with 50 consecutive age-matched control patients who had OSAS but had not been deployed and did not have PTSD, as well as with 50 age-matched service members without prior deployment or either of the two disorders. All of the patients diagnosed with OSAS were prescribed positive airway pressure (PAP) therapy and evaluated after a month.
Sleep quality was poor in the majority of patients with PTSD, and OSAS and PTSD were both independently associated with increased daytime sleepiness and lower quality-of-life index scores. However, patients with both conditions fared significantly worse, particularly with respect to quality of life as measured by the Functional Outcomes of Sleep Questionnaire (FOSQ).
FOSQ scores were abnormal at baseline in 60% of those with PTSD and OSAS, 43% with PTSD alone, 24% with OSAS alone, and 7% of those with neither condition.
Service members with both conditions also were less likely to adhere to therapy; 30% regularly used continuous PAP therapy, compared with 55% of those who had OSAS alone.
And while continuous PAP therapy improved daytime sleepiness and quality of life in patients with both PTSD and OSAS, the degree of improvement was less than that experienced by those with OSAS alone. PTSD “represents an independent barrier to the effective treatment of OSAS and should prompt multipronged and individualized care,” they wrote.
The researchers reported having no financial disclosures.
Obstructive sleep apnea syndrome (OSAS) was diagnosed in more than half of 200 active duty service members with combat-related post-traumatic stress disorder (PTSD) who were studied at Walter Reed Army Medical Center in Washington.
Compared with age-matched peers with just one of these disorders, the service members with PTSD and OSAS had poorer somnolence and sleep-related quality of life and were less adherent and responsive to positive airway pressure therapy.
The findings “highlight the need for a high index of suspicion and a comprehensive approach to identifying and treating sleep-disordered breathing in these patients,” Dr. Christopher J. Lettieri of the Uniformed Services University in Bethesda, Md., and his associates wrote (Chest. 2016 Feb;149[2]:483-90). “Given the prevalence of OSAS in patients with PTSD and its adverse impact on symptoms and adherence, early identification may improve outcomes.”
In the observational cohort study, 200 consecutive active duty service members who were diagnosed with PTSD as part of post-deployment screening underwent sleep evaluations regardless of whether there was clinical suspicion of sleep-disordered breathing. More than half – about 57% – were diagnosed with OSAS. Almost 60% of the study group had mild traumatic brain injury, which has been connected in prior research to obstructive sleep apnea, and many had comorbid insomnia. Those who were diagnosed with OSAS were older and had higher BMIs than those not found to have OSAS.
All 200 patients were compared with 50 consecutive age-matched control patients who had OSAS but had not been deployed and did not have PTSD, as well as with 50 age-matched service members without prior deployment or either of the two disorders. All of the patients diagnosed with OSAS were prescribed positive airway pressure (PAP) therapy and evaluated after a month.
Sleep quality was poor in the majority of patients with PTSD, and OSAS and PTSD were both independently associated with increased daytime sleepiness and lower quality-of-life index scores. However, patients with both conditions fared significantly worse, particularly with respect to quality of life as measured by the Functional Outcomes of Sleep Questionnaire (FOSQ).
FOSQ scores were abnormal at baseline in 60% of those with PTSD and OSAS, 43% with PTSD alone, 24% with OSAS alone, and 7% of those with neither condition.
Service members with both conditions also were less likely to adhere to therapy; 30% regularly used continuous PAP therapy, compared with 55% of those who had OSAS alone.
And while continuous PAP therapy improved daytime sleepiness and quality of life in patients with both PTSD and OSAS, the degree of improvement was less than that experienced by those with OSAS alone. PTSD “represents an independent barrier to the effective treatment of OSAS and should prompt multipronged and individualized care,” they wrote.
The researchers reported having no financial disclosures.
FROM CHEST
Key clinical point: Obstructive sleep apnea is prevalent in service members with PTSD.
Major finding: More than 57% of active duty service members with combat-related PTSD were diagnosed with OSAS.
Data source: A case-controlled observational cohort study conducted at an academic military medical center and involving 200 consecutive patients with PTSD.
Disclosures: Dr. Lettieri and his colleagues did not report any conflicts of interest.
New drug comparable to voriconazole for aspergillosis
The broad-spectrum triazole isavuconazole was as effective as voriconazole in patients with suspected invasive mold disease and caused significantly fewer drug-related adverse events, particularly those of the skin, eyes, and hepatobiliary system, a randomized double-blind study of 516 adults has shown.
The findings suggest that the newer agent “could allow safer therapy” for the primary treatment of invasive aspergillosis and other mold disease than standard therapy with voriconazole, researchers for the phase III, industry-sponsored SECURE trial say in a report published in the Lancet.
The researchers assessed the safety and efficacy of isavuconazole versus voriconazole in patients with invasive mold infection. Patients were recruited from 102 centers across 26 countries over a 7-year period and were randomized to receive either drug.
In the study group of 516 adults with suspected invasive mold infection who received at least one dose of either antifungal drug, isavuconazole proved to be noninferior to voriconazole, by the primary endpoint of all-cause mortality at 6 weeks.
All-cause mortality at 6 weeks in this intention-to-treat group, of whom more than 80% had hematologic malignant disease, was 19% in the isavuconazole group (48 of 258) and 20% (52 of 258) in the voriconazole group.
This primary endpoint was chosen because “it provides the most objective and reproducible effect of therapy, and approximates best the attributable mortality, because deaths due to competing causes occur increasingly after 6 weeks,” Dr. Johan A. Maertensof the UZ Leuven (Belgium), and his associates wrote.
Secondary endpoints included overall response at the end of treatment among patients who were determined by an independent review committee to have proven or probable invasive mold disease – the study’s modified intention-to-treat population – as well as all-cause mortality at day 42 and day 84.
All-cause mortality in this modified intention-to-treat group, as well as in the group of patients found to have proven or probable invasive aspergillosis, specifically, supported the study’s primary findings (Lancet 2016 Feb:387:760-9).
Nearly all patients in the study had at least one treatment-emergent adverse event, and the proportion with serious treatment-emergent adverse events was similar between the treatment groups. However, patients treated with isavuconazole had a significantly lower frequency of hepatobiliary disorders, eye disorders, and skin or subcutaneous disorders.
And overall, significantly fewer patients reported drug-related adverse events with isavuconazole (42% of patients) than with voriconazole (60% of patients). Discontinuation from adverse events, moreover, was significantly less common among isavuconazole-treated patients.
Of the 516 patients in the intention-to-treat group, approximately 53% were confirmed to have proven or probable invasive mold disease, and more than 80% of the mycologically documented cases were Aspergillus infections. Enrollment of patients with possible invasive mold disease at the start “reflects the real-life strategy of early initiation of antifungal treatment,” the investigators say.
Isavuconazonium sulfate was approved in 2015 by the FDA for the treatment of invasive aspergillosis and invasive mucormycosis.
Voriconazole is the current gold standard for the primary treatment of invasive aspergillosis and is recommended for some other mold infections as well, but it is not active against mucormycosis and has “highly variable nonlinear pharmacokinetics in adults,” which has triggered recommendations for drug monitoring, Dr. Maertens and his associates say.
Therapeutic monitoring aimed at individualizing dosage regimes in order to improve response and prevent adverse events became the standard of care in some institutions during the study period (2007-2013). The study used the labeled dose of voriconazole, however, and did not address the efficacy of either drug with therapeutic drug monitoring.
The study also excluded patients with AIDS, abnormal liver or renal function, and those receiving antifungal prophylaxis with a mold-active triazole – factors that may limit generalizability of the findings, the investigators note.
Funding for the study was provided by Astellas Pharma Global Development and Basilea Pharmaceutica International.
Dr. Maertens disclosed receiving grants and fees from Bio-Rad, personal fees and nonfinancial support from Astellas and Basilea, and grants, fees and support from Gilead Sciences, Merck Sharp and Dohme, and Pfizer during the study.
The advantages of isavuconazole over voriconazole include its broader spectrum of activity, linear pharmacokinetics, once-daily dosing after the loading dose, and fewer CYP enzyme-mediated drug-drug interactions. This trial represents important progress in widening the therapeutic options for mold infections.
Numerous issues require further evaluation, including the effectiveness of isavuconazole after mold-active triazole prophylaxis, which is a common practice in patients at risk for mold infection, and the agent’s effectiveness against molds other than Aspergillus.
In addition, experience in a more varied patient population will be required to be certain that therapeutic drug monitoring is unnecessary.
Cost-effectiveness must also be explored. Isavuconazole will probably achieve an equivalent recommendation as voriconazole for initial treatment of aspergillosis in clinical guidelines, but voriconazole will soon come off patent in many countries and new formulations of posaconazole are now available.
That the finding that 42-day mortality in both treatment groups (isavuconazole and voriconazole) was no different than the mortality seen in research done 15 years ago on voriconazole treatment of aspergillosis is disappointing and suggests that we need to do better with the prevention and early detection of mold infection in vulnerable patients.
Dr. Monica A. Slavin and Dr. Karin A. Thursky are affiliated with the Peter MacCallum Cancer Centre, East Melbourne, Australia. Their comments are excerpted from an accompanying editorial in the Lancet. Dr. Slavin reported receiving grants from Merck, Gilead, and Pfizer. Dr. Thursky reported no disclosures.
The advantages of isavuconazole over voriconazole include its broader spectrum of activity, linear pharmacokinetics, once-daily dosing after the loading dose, and fewer CYP enzyme-mediated drug-drug interactions. This trial represents important progress in widening the therapeutic options for mold infections.
Numerous issues require further evaluation, including the effectiveness of isavuconazole after mold-active triazole prophylaxis, which is a common practice in patients at risk for mold infection, and the agent’s effectiveness against molds other than Aspergillus.
In addition, experience in a more varied patient population will be required to be certain that therapeutic drug monitoring is unnecessary.
Cost-effectiveness must also be explored. Isavuconazole will probably achieve an equivalent recommendation as voriconazole for initial treatment of aspergillosis in clinical guidelines, but voriconazole will soon come off patent in many countries and new formulations of posaconazole are now available.
That the finding that 42-day mortality in both treatment groups (isavuconazole and voriconazole) was no different than the mortality seen in research done 15 years ago on voriconazole treatment of aspergillosis is disappointing and suggests that we need to do better with the prevention and early detection of mold infection in vulnerable patients.
Dr. Monica A. Slavin and Dr. Karin A. Thursky are affiliated with the Peter MacCallum Cancer Centre, East Melbourne, Australia. Their comments are excerpted from an accompanying editorial in the Lancet. Dr. Slavin reported receiving grants from Merck, Gilead, and Pfizer. Dr. Thursky reported no disclosures.
The advantages of isavuconazole over voriconazole include its broader spectrum of activity, linear pharmacokinetics, once-daily dosing after the loading dose, and fewer CYP enzyme-mediated drug-drug interactions. This trial represents important progress in widening the therapeutic options for mold infections.
Numerous issues require further evaluation, including the effectiveness of isavuconazole after mold-active triazole prophylaxis, which is a common practice in patients at risk for mold infection, and the agent’s effectiveness against molds other than Aspergillus.
In addition, experience in a more varied patient population will be required to be certain that therapeutic drug monitoring is unnecessary.
Cost-effectiveness must also be explored. Isavuconazole will probably achieve an equivalent recommendation as voriconazole for initial treatment of aspergillosis in clinical guidelines, but voriconazole will soon come off patent in many countries and new formulations of posaconazole are now available.
That the finding that 42-day mortality in both treatment groups (isavuconazole and voriconazole) was no different than the mortality seen in research done 15 years ago on voriconazole treatment of aspergillosis is disappointing and suggests that we need to do better with the prevention and early detection of mold infection in vulnerable patients.
Dr. Monica A. Slavin and Dr. Karin A. Thursky are affiliated with the Peter MacCallum Cancer Centre, East Melbourne, Australia. Their comments are excerpted from an accompanying editorial in the Lancet. Dr. Slavin reported receiving grants from Merck, Gilead, and Pfizer. Dr. Thursky reported no disclosures.
The broad-spectrum triazole isavuconazole was as effective as voriconazole in patients with suspected invasive mold disease and caused significantly fewer drug-related adverse events, particularly those of the skin, eyes, and hepatobiliary system, a randomized double-blind study of 516 adults has shown.
The findings suggest that the newer agent “could allow safer therapy” for the primary treatment of invasive aspergillosis and other mold disease than standard therapy with voriconazole, researchers for the phase III, industry-sponsored SECURE trial say in a report published in the Lancet.
The researchers assessed the safety and efficacy of isavuconazole versus voriconazole in patients with invasive mold infection. Patients were recruited from 102 centers across 26 countries over a 7-year period and were randomized to receive either drug.
In the study group of 516 adults with suspected invasive mold infection who received at least one dose of either antifungal drug, isavuconazole proved to be noninferior to voriconazole, by the primary endpoint of all-cause mortality at 6 weeks.
All-cause mortality at 6 weeks in this intention-to-treat group, of whom more than 80% had hematologic malignant disease, was 19% in the isavuconazole group (48 of 258) and 20% (52 of 258) in the voriconazole group.
This primary endpoint was chosen because “it provides the most objective and reproducible effect of therapy, and approximates best the attributable mortality, because deaths due to competing causes occur increasingly after 6 weeks,” Dr. Johan A. Maertensof the UZ Leuven (Belgium), and his associates wrote.
Secondary endpoints included overall response at the end of treatment among patients who were determined by an independent review committee to have proven or probable invasive mold disease – the study’s modified intention-to-treat population – as well as all-cause mortality at day 42 and day 84.
All-cause mortality in this modified intention-to-treat group, as well as in the group of patients found to have proven or probable invasive aspergillosis, specifically, supported the study’s primary findings (Lancet 2016 Feb:387:760-9).
Nearly all patients in the study had at least one treatment-emergent adverse event, and the proportion with serious treatment-emergent adverse events was similar between the treatment groups. However, patients treated with isavuconazole had a significantly lower frequency of hepatobiliary disorders, eye disorders, and skin or subcutaneous disorders.
And overall, significantly fewer patients reported drug-related adverse events with isavuconazole (42% of patients) than with voriconazole (60% of patients). Discontinuation from adverse events, moreover, was significantly less common among isavuconazole-treated patients.
Of the 516 patients in the intention-to-treat group, approximately 53% were confirmed to have proven or probable invasive mold disease, and more than 80% of the mycologically documented cases were Aspergillus infections. Enrollment of patients with possible invasive mold disease at the start “reflects the real-life strategy of early initiation of antifungal treatment,” the investigators say.
Isavuconazonium sulfate was approved in 2015 by the FDA for the treatment of invasive aspergillosis and invasive mucormycosis.
Voriconazole is the current gold standard for the primary treatment of invasive aspergillosis and is recommended for some other mold infections as well, but it is not active against mucormycosis and has “highly variable nonlinear pharmacokinetics in adults,” which has triggered recommendations for drug monitoring, Dr. Maertens and his associates say.
Therapeutic monitoring aimed at individualizing dosage regimes in order to improve response and prevent adverse events became the standard of care in some institutions during the study period (2007-2013). The study used the labeled dose of voriconazole, however, and did not address the efficacy of either drug with therapeutic drug monitoring.
The study also excluded patients with AIDS, abnormal liver or renal function, and those receiving antifungal prophylaxis with a mold-active triazole – factors that may limit generalizability of the findings, the investigators note.
Funding for the study was provided by Astellas Pharma Global Development and Basilea Pharmaceutica International.
Dr. Maertens disclosed receiving grants and fees from Bio-Rad, personal fees and nonfinancial support from Astellas and Basilea, and grants, fees and support from Gilead Sciences, Merck Sharp and Dohme, and Pfizer during the study.
The broad-spectrum triazole isavuconazole was as effective as voriconazole in patients with suspected invasive mold disease and caused significantly fewer drug-related adverse events, particularly those of the skin, eyes, and hepatobiliary system, a randomized double-blind study of 516 adults has shown.
The findings suggest that the newer agent “could allow safer therapy” for the primary treatment of invasive aspergillosis and other mold disease than standard therapy with voriconazole, researchers for the phase III, industry-sponsored SECURE trial say in a report published in the Lancet.
The researchers assessed the safety and efficacy of isavuconazole versus voriconazole in patients with invasive mold infection. Patients were recruited from 102 centers across 26 countries over a 7-year period and were randomized to receive either drug.
In the study group of 516 adults with suspected invasive mold infection who received at least one dose of either antifungal drug, isavuconazole proved to be noninferior to voriconazole, by the primary endpoint of all-cause mortality at 6 weeks.
All-cause mortality at 6 weeks in this intention-to-treat group, of whom more than 80% had hematologic malignant disease, was 19% in the isavuconazole group (48 of 258) and 20% (52 of 258) in the voriconazole group.
This primary endpoint was chosen because “it provides the most objective and reproducible effect of therapy, and approximates best the attributable mortality, because deaths due to competing causes occur increasingly after 6 weeks,” Dr. Johan A. Maertensof the UZ Leuven (Belgium), and his associates wrote.
Secondary endpoints included overall response at the end of treatment among patients who were determined by an independent review committee to have proven or probable invasive mold disease – the study’s modified intention-to-treat population – as well as all-cause mortality at day 42 and day 84.
All-cause mortality in this modified intention-to-treat group, as well as in the group of patients found to have proven or probable invasive aspergillosis, specifically, supported the study’s primary findings (Lancet 2016 Feb:387:760-9).
Nearly all patients in the study had at least one treatment-emergent adverse event, and the proportion with serious treatment-emergent adverse events was similar between the treatment groups. However, patients treated with isavuconazole had a significantly lower frequency of hepatobiliary disorders, eye disorders, and skin or subcutaneous disorders.
And overall, significantly fewer patients reported drug-related adverse events with isavuconazole (42% of patients) than with voriconazole (60% of patients). Discontinuation from adverse events, moreover, was significantly less common among isavuconazole-treated patients.
Of the 516 patients in the intention-to-treat group, approximately 53% were confirmed to have proven or probable invasive mold disease, and more than 80% of the mycologically documented cases were Aspergillus infections. Enrollment of patients with possible invasive mold disease at the start “reflects the real-life strategy of early initiation of antifungal treatment,” the investigators say.
Isavuconazonium sulfate was approved in 2015 by the FDA for the treatment of invasive aspergillosis and invasive mucormycosis.
Voriconazole is the current gold standard for the primary treatment of invasive aspergillosis and is recommended for some other mold infections as well, but it is not active against mucormycosis and has “highly variable nonlinear pharmacokinetics in adults,” which has triggered recommendations for drug monitoring, Dr. Maertens and his associates say.
Therapeutic monitoring aimed at individualizing dosage regimes in order to improve response and prevent adverse events became the standard of care in some institutions during the study period (2007-2013). The study used the labeled dose of voriconazole, however, and did not address the efficacy of either drug with therapeutic drug monitoring.
The study also excluded patients with AIDS, abnormal liver or renal function, and those receiving antifungal prophylaxis with a mold-active triazole – factors that may limit generalizability of the findings, the investigators note.
Funding for the study was provided by Astellas Pharma Global Development and Basilea Pharmaceutica International.
Dr. Maertens disclosed receiving grants and fees from Bio-Rad, personal fees and nonfinancial support from Astellas and Basilea, and grants, fees and support from Gilead Sciences, Merck Sharp and Dohme, and Pfizer during the study.
FROM THE LANCET
Key clinical point: Isavuconazole is an appropriate alternative for primary treatment of suspected invasive aspergillosis.
Major finding: All-cause mortality at 6 weeks in the intention-to-treat group of 516 patients was 19% with isavuconazole and 20% with voriconazole. Fewer drug-related adverse events were reported with isavuconazole, however (42% vs. 60% of patients).
Data source: A phase III randomized, double-blind noninferiority trial – the SECURE trial – comparing the safety and efficacy of intravenous and oral formulations of isavuconazole and voriconazole for the primary treatment of invasive aspergillosis and disease caused by other molds.
Disclosures: Funding for the study was provided by Astellas Pharma Global Development and Basilea Pharmaceutica International. Dr. Maertens disclosed receiving grants and fees from Bio-Rad, personal fees and nonfinancial support from Astellas and Basilea, and grants, fees, and support from Gilead Sciences, Merck Sharp and Dohme, and Pfizer, during the study.
Ibrutinib bodes well for relapsed mantle-cell lymphoma
Progression-free survival was significantly better when patients with relapsed or refractory mantle-cell lymphoma were treated with oral ibrutinib than with intravenous temsirolimus, based on results from 280 patients in an international, randomized, open-label phase III trial.
Study subjects had undergone one or more previous rituximab-containing chemotherapy regimens to receive intravenous temsirolimus or oral ibrutinib at a daily dose of 560 mg.
Compared with temsirolimus, ibrutinib resulted in a 57% reduction in the risk of disease progression or death at a median follow-up of 20 months. Median progression-free survival – the trial’s primary endpoint – was 14.6 months for the ibrutinib group and 6.2 months for the temsirolimus group.
Ibrutinib was also better tolerated, with 68% of patients having grade 3 or higher treatment-emergent adverse events as compared to 87% of patients in the temsirolimus group, despite a median 4-fold longer treatment duration for the ibrutinib group than the temsirolimus group. Additionally, 6% of patients discontinued ibrutinib because of adverse events versus 26% in the temsirolimus group, reported Dr. Martin Dreyling of Klinikum der Universität in Munich, Germany, and his associates.
Based on results of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) questionnaire, ibrutinib was associated with greater and more rapid improvements, and also with less worsening in lymphoma symptoms, as measured by the lymphoma subscale of the FACT-Lym (Lancet. 2016;387:770-78).
Ibrutinib, a first-in-class oral inhibitor of Bruton’s tyrosine kinase, is approved in the United States and the European Union at a dose of 560 mg per day for patients with mantle cell lymphoma who have received at least one previous line of therapy.
The mammalian target of rapamycin (mTOR) inhibitor temsirolimus is approved in the European Union for relapsed or refractory mantle-cell lymphoma, but does not have FDA approval for this indication.
The study, funded by Janssen, is ongoing. Future research, the investigators say, should examine ibrutinib-based combination approaches for patients with relapsed or refractory mantle-cell lymphoma and in front-line therapy.
Dr. Dreyling reported grants and personal fees from Janssen and Pfizer outside of the study. Several other authors reported grants from Janssen during the study and financial ties to the company.
The findings from this phase III trial clearly establish ibrutinib as a new standard for treatment of relapsed mantle-cell lymphoma. Within the next 2 years, many expect the agent will find its way into the frontline setting for treatment of mantle cell lymphoma in combination with standard chemotherapy, based on results of another already completed phase III trial (the SHINE trial).
Despite this remarkable progress, however, mantle-cell lymphoma remains incurable. Roughly 30%-40% of people with the disease will not respond to ibrutinib, and even among responders relapse seems inevitable.
Mantle-cell lymphoma has been a model for accelerated development of novel drugs. Ibrutinib was developed with tremendous speed, and the FDA’s approval of the agent in 2013 based on findings from a non-pivotal phase II trial was surprising to everyone other than the participating patients and physicians. Hopefully the resources mobilized to bring ibrutinib so far, so fast, will continue to be available to help us learn how best to use the drug.
Dr. Peter Martin is with the department of medicine at Weill Cornell Medical College in New York. His comments are excerpted from an editorial that accompanied the study in The Lancet. Dr. Martin reported that he is a consultant for Janssen and has received honoraria from the company for speaking.
The findings from this phase III trial clearly establish ibrutinib as a new standard for treatment of relapsed mantle-cell lymphoma. Within the next 2 years, many expect the agent will find its way into the frontline setting for treatment of mantle cell lymphoma in combination with standard chemotherapy, based on results of another already completed phase III trial (the SHINE trial).
Despite this remarkable progress, however, mantle-cell lymphoma remains incurable. Roughly 30%-40% of people with the disease will not respond to ibrutinib, and even among responders relapse seems inevitable.
Mantle-cell lymphoma has been a model for accelerated development of novel drugs. Ibrutinib was developed with tremendous speed, and the FDA’s approval of the agent in 2013 based on findings from a non-pivotal phase II trial was surprising to everyone other than the participating patients and physicians. Hopefully the resources mobilized to bring ibrutinib so far, so fast, will continue to be available to help us learn how best to use the drug.
Dr. Peter Martin is with the department of medicine at Weill Cornell Medical College in New York. His comments are excerpted from an editorial that accompanied the study in The Lancet. Dr. Martin reported that he is a consultant for Janssen and has received honoraria from the company for speaking.
The findings from this phase III trial clearly establish ibrutinib as a new standard for treatment of relapsed mantle-cell lymphoma. Within the next 2 years, many expect the agent will find its way into the frontline setting for treatment of mantle cell lymphoma in combination with standard chemotherapy, based on results of another already completed phase III trial (the SHINE trial).
Despite this remarkable progress, however, mantle-cell lymphoma remains incurable. Roughly 30%-40% of people with the disease will not respond to ibrutinib, and even among responders relapse seems inevitable.
Mantle-cell lymphoma has been a model for accelerated development of novel drugs. Ibrutinib was developed with tremendous speed, and the FDA’s approval of the agent in 2013 based on findings from a non-pivotal phase II trial was surprising to everyone other than the participating patients and physicians. Hopefully the resources mobilized to bring ibrutinib so far, so fast, will continue to be available to help us learn how best to use the drug.
Dr. Peter Martin is with the department of medicine at Weill Cornell Medical College in New York. His comments are excerpted from an editorial that accompanied the study in The Lancet. Dr. Martin reported that he is a consultant for Janssen and has received honoraria from the company for speaking.
Progression-free survival was significantly better when patients with relapsed or refractory mantle-cell lymphoma were treated with oral ibrutinib than with intravenous temsirolimus, based on results from 280 patients in an international, randomized, open-label phase III trial.
Study subjects had undergone one or more previous rituximab-containing chemotherapy regimens to receive intravenous temsirolimus or oral ibrutinib at a daily dose of 560 mg.
Compared with temsirolimus, ibrutinib resulted in a 57% reduction in the risk of disease progression or death at a median follow-up of 20 months. Median progression-free survival – the trial’s primary endpoint – was 14.6 months for the ibrutinib group and 6.2 months for the temsirolimus group.
Ibrutinib was also better tolerated, with 68% of patients having grade 3 or higher treatment-emergent adverse events as compared to 87% of patients in the temsirolimus group, despite a median 4-fold longer treatment duration for the ibrutinib group than the temsirolimus group. Additionally, 6% of patients discontinued ibrutinib because of adverse events versus 26% in the temsirolimus group, reported Dr. Martin Dreyling of Klinikum der Universität in Munich, Germany, and his associates.
Based on results of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) questionnaire, ibrutinib was associated with greater and more rapid improvements, and also with less worsening in lymphoma symptoms, as measured by the lymphoma subscale of the FACT-Lym (Lancet. 2016;387:770-78).
Ibrutinib, a first-in-class oral inhibitor of Bruton’s tyrosine kinase, is approved in the United States and the European Union at a dose of 560 mg per day for patients with mantle cell lymphoma who have received at least one previous line of therapy.
The mammalian target of rapamycin (mTOR) inhibitor temsirolimus is approved in the European Union for relapsed or refractory mantle-cell lymphoma, but does not have FDA approval for this indication.
The study, funded by Janssen, is ongoing. Future research, the investigators say, should examine ibrutinib-based combination approaches for patients with relapsed or refractory mantle-cell lymphoma and in front-line therapy.
Dr. Dreyling reported grants and personal fees from Janssen and Pfizer outside of the study. Several other authors reported grants from Janssen during the study and financial ties to the company.
Progression-free survival was significantly better when patients with relapsed or refractory mantle-cell lymphoma were treated with oral ibrutinib than with intravenous temsirolimus, based on results from 280 patients in an international, randomized, open-label phase III trial.
Study subjects had undergone one or more previous rituximab-containing chemotherapy regimens to receive intravenous temsirolimus or oral ibrutinib at a daily dose of 560 mg.
Compared with temsirolimus, ibrutinib resulted in a 57% reduction in the risk of disease progression or death at a median follow-up of 20 months. Median progression-free survival – the trial’s primary endpoint – was 14.6 months for the ibrutinib group and 6.2 months for the temsirolimus group.
Ibrutinib was also better tolerated, with 68% of patients having grade 3 or higher treatment-emergent adverse events as compared to 87% of patients in the temsirolimus group, despite a median 4-fold longer treatment duration for the ibrutinib group than the temsirolimus group. Additionally, 6% of patients discontinued ibrutinib because of adverse events versus 26% in the temsirolimus group, reported Dr. Martin Dreyling of Klinikum der Universität in Munich, Germany, and his associates.
Based on results of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) questionnaire, ibrutinib was associated with greater and more rapid improvements, and also with less worsening in lymphoma symptoms, as measured by the lymphoma subscale of the FACT-Lym (Lancet. 2016;387:770-78).
Ibrutinib, a first-in-class oral inhibitor of Bruton’s tyrosine kinase, is approved in the United States and the European Union at a dose of 560 mg per day for patients with mantle cell lymphoma who have received at least one previous line of therapy.
The mammalian target of rapamycin (mTOR) inhibitor temsirolimus is approved in the European Union for relapsed or refractory mantle-cell lymphoma, but does not have FDA approval for this indication.
The study, funded by Janssen, is ongoing. Future research, the investigators say, should examine ibrutinib-based combination approaches for patients with relapsed or refractory mantle-cell lymphoma and in front-line therapy.
Dr. Dreyling reported grants and personal fees from Janssen and Pfizer outside of the study. Several other authors reported grants from Janssen during the study and financial ties to the company.
FROM THE LANCET
Key clinical point: Ibrutinib significantly improved progression-free survival, compared with temsirolimus in patients with relapsed or refractory mantle-cell lymphoma.
Major finding: Median progression-free survival was 14.6 months with ibrutinib and 6.2 months with temsirolimus.
Data source: A randomized open-label phase III trial (ongoing) that randomized 280 patients to each treatment group.
Disclosures: The study was funded by Janssen. Dr. Dreyling reported grants and personal fees from Janssen and Pfizer outside of the study, and other authors reported grants from Janssen during the study and financial ties to the company.
Good Samaritan protection should ease pediatricians’ hesitations
“If there is a doctor or nurse on board, please identify yourself by pushing the attendant call button.”
For pediatricians, such calls for voluntary emergency help can be simple and ethically clear on one hand, but legally worrisome and uncomfortable on the other.
“We’ve all hesitated,” Dr. Steven M. Donn, former chair of the American Academy of Pediatrics’ Committee on Medical Liability & Risk Management, said at the AAP’s annual meeting in Washington. “We often find ourselves in various scenarios, not with our pediatric population, but with elderly and younger adults, when we feel like we may be in over our heads. And we’re also afraid we’ll get sued.”
Good Samaritan laws in all 50 states, however, provide legal protection for good faith attempts to help, even if such attempts are technically “negligent.”
“The goal of these laws is to strike the right balance … to reduce liability enough to motivate volunteerism, but to preserve enough liability to prevent reckless or harmful interactions,” said Dr. Dunn, a professor of pediatrics at the University of Michigan, Ann Arbor.
While the laws provide legal immunity against ordinary negligence (doing something that an average, reasonable person would not do), there is not generally no immunity provided for “gross negligence,” which is defined as reckless and willful disregard for the safety of others.
He urged pediatricians to remember three criteria for immunity: That it is an emergency situation, where failure to intervene could result in death or severe bodily harm; that the responder acts without compensation; and that the responder acts rationally, in good faith, and without gross negligence.
“Don’t be afraid to get involved,” Dr. Dunn said. “Just keep within the limits of your abilities and provide help in good faith. Do the Heimlich maneuver, for instance, but don’t ask for a dinner knife to do a tracheotomy.”
And with regards to compensation, it’s fine to accept a free drink on an airplane, but not to accept free airline tickets, he said.
A case scenario: An elderly woman falls on an escalator in a shopping mall, sustaining an apparent head and neck injury. You offer assistance, stabilize the head and neck, and request a call to 911. The woman is taken to the emergency room, and the store manager gives you a $500 gift certificate in gratitude. Unfortunately, however, the woman has a bad outcome and sues you for negligence. “By accepting the gift certificate, you’ve [in all likelihood] lost your [Good Samaritan] protection,” he said.
Patients and parents can refuse help, and helping despite refusal is usually deemed to be not in “good faith.” There may be exceptions, however. “Say you’re waiting for your child in the middle school parking lot when you see another child struck by lightning. You initiate CPR, and as you’re administering CPR the father of the child arrives and greets you with ‘If anything happens to my child, I am going to sue you,’ “ Dr. Dunn said. “What are the risks of continuing care?”
“You’d just need to be aware that there could be a separate charge for care without consent, or even assault and battery,” Dr. Dunn said. “But I think it’s one you could probably win since you were acting in good faith to provide lifesaving attention.”
Good Samaritan laws generally do not apply to medical professionals while “on the job,” but some states extend protection to medical professionals who render emergency assistance in a hospital or other “health care setting” when such assistance is beyond the scope of their work duties.
“So if you’re walking down the hallway, and someone collapses and you offer assistance, even though you’re not the patient’s physician, in some states you’ll be covered by the Good Samaritan law,” Dr. Dunn said. “So it’s helpful to know your state’s laws.”
Good Samaritan assistance during commercial flights is governed by the federal Aviation Medical Assistance Act of 1998; the law protects providers who respond to in-flight medical emergencies against liability for negligence. Medical emergencies occur in about 1 of every 600 flights, and physicians assist in nearly half of these cases, according to a 2013 study (N Engl J Med. 2013 Aug 29;369[9]:877).
“If there is a doctor or nurse on board, please identify yourself by pushing the attendant call button.”
For pediatricians, such calls for voluntary emergency help can be simple and ethically clear on one hand, but legally worrisome and uncomfortable on the other.
“We’ve all hesitated,” Dr. Steven M. Donn, former chair of the American Academy of Pediatrics’ Committee on Medical Liability & Risk Management, said at the AAP’s annual meeting in Washington. “We often find ourselves in various scenarios, not with our pediatric population, but with elderly and younger adults, when we feel like we may be in over our heads. And we’re also afraid we’ll get sued.”
Good Samaritan laws in all 50 states, however, provide legal protection for good faith attempts to help, even if such attempts are technically “negligent.”
“The goal of these laws is to strike the right balance … to reduce liability enough to motivate volunteerism, but to preserve enough liability to prevent reckless or harmful interactions,” said Dr. Dunn, a professor of pediatrics at the University of Michigan, Ann Arbor.
While the laws provide legal immunity against ordinary negligence (doing something that an average, reasonable person would not do), there is not generally no immunity provided for “gross negligence,” which is defined as reckless and willful disregard for the safety of others.
He urged pediatricians to remember three criteria for immunity: That it is an emergency situation, where failure to intervene could result in death or severe bodily harm; that the responder acts without compensation; and that the responder acts rationally, in good faith, and without gross negligence.
“Don’t be afraid to get involved,” Dr. Dunn said. “Just keep within the limits of your abilities and provide help in good faith. Do the Heimlich maneuver, for instance, but don’t ask for a dinner knife to do a tracheotomy.”
And with regards to compensation, it’s fine to accept a free drink on an airplane, but not to accept free airline tickets, he said.
A case scenario: An elderly woman falls on an escalator in a shopping mall, sustaining an apparent head and neck injury. You offer assistance, stabilize the head and neck, and request a call to 911. The woman is taken to the emergency room, and the store manager gives you a $500 gift certificate in gratitude. Unfortunately, however, the woman has a bad outcome and sues you for negligence. “By accepting the gift certificate, you’ve [in all likelihood] lost your [Good Samaritan] protection,” he said.
Patients and parents can refuse help, and helping despite refusal is usually deemed to be not in “good faith.” There may be exceptions, however. “Say you’re waiting for your child in the middle school parking lot when you see another child struck by lightning. You initiate CPR, and as you’re administering CPR the father of the child arrives and greets you with ‘If anything happens to my child, I am going to sue you,’ “ Dr. Dunn said. “What are the risks of continuing care?”
“You’d just need to be aware that there could be a separate charge for care without consent, or even assault and battery,” Dr. Dunn said. “But I think it’s one you could probably win since you were acting in good faith to provide lifesaving attention.”
Good Samaritan laws generally do not apply to medical professionals while “on the job,” but some states extend protection to medical professionals who render emergency assistance in a hospital or other “health care setting” when such assistance is beyond the scope of their work duties.
“So if you’re walking down the hallway, and someone collapses and you offer assistance, even though you’re not the patient’s physician, in some states you’ll be covered by the Good Samaritan law,” Dr. Dunn said. “So it’s helpful to know your state’s laws.”
Good Samaritan assistance during commercial flights is governed by the federal Aviation Medical Assistance Act of 1998; the law protects providers who respond to in-flight medical emergencies against liability for negligence. Medical emergencies occur in about 1 of every 600 flights, and physicians assist in nearly half of these cases, according to a 2013 study (N Engl J Med. 2013 Aug 29;369[9]:877).
“If there is a doctor or nurse on board, please identify yourself by pushing the attendant call button.”
For pediatricians, such calls for voluntary emergency help can be simple and ethically clear on one hand, but legally worrisome and uncomfortable on the other.
“We’ve all hesitated,” Dr. Steven M. Donn, former chair of the American Academy of Pediatrics’ Committee on Medical Liability & Risk Management, said at the AAP’s annual meeting in Washington. “We often find ourselves in various scenarios, not with our pediatric population, but with elderly and younger adults, when we feel like we may be in over our heads. And we’re also afraid we’ll get sued.”
Good Samaritan laws in all 50 states, however, provide legal protection for good faith attempts to help, even if such attempts are technically “negligent.”
“The goal of these laws is to strike the right balance … to reduce liability enough to motivate volunteerism, but to preserve enough liability to prevent reckless or harmful interactions,” said Dr. Dunn, a professor of pediatrics at the University of Michigan, Ann Arbor.
While the laws provide legal immunity against ordinary negligence (doing something that an average, reasonable person would not do), there is not generally no immunity provided for “gross negligence,” which is defined as reckless and willful disregard for the safety of others.
He urged pediatricians to remember three criteria for immunity: That it is an emergency situation, where failure to intervene could result in death or severe bodily harm; that the responder acts without compensation; and that the responder acts rationally, in good faith, and without gross negligence.
“Don’t be afraid to get involved,” Dr. Dunn said. “Just keep within the limits of your abilities and provide help in good faith. Do the Heimlich maneuver, for instance, but don’t ask for a dinner knife to do a tracheotomy.”
And with regards to compensation, it’s fine to accept a free drink on an airplane, but not to accept free airline tickets, he said.
A case scenario: An elderly woman falls on an escalator in a shopping mall, sustaining an apparent head and neck injury. You offer assistance, stabilize the head and neck, and request a call to 911. The woman is taken to the emergency room, and the store manager gives you a $500 gift certificate in gratitude. Unfortunately, however, the woman has a bad outcome and sues you for negligence. “By accepting the gift certificate, you’ve [in all likelihood] lost your [Good Samaritan] protection,” he said.
Patients and parents can refuse help, and helping despite refusal is usually deemed to be not in “good faith.” There may be exceptions, however. “Say you’re waiting for your child in the middle school parking lot when you see another child struck by lightning. You initiate CPR, and as you’re administering CPR the father of the child arrives and greets you with ‘If anything happens to my child, I am going to sue you,’ “ Dr. Dunn said. “What are the risks of continuing care?”
“You’d just need to be aware that there could be a separate charge for care without consent, or even assault and battery,” Dr. Dunn said. “But I think it’s one you could probably win since you were acting in good faith to provide lifesaving attention.”
Good Samaritan laws generally do not apply to medical professionals while “on the job,” but some states extend protection to medical professionals who render emergency assistance in a hospital or other “health care setting” when such assistance is beyond the scope of their work duties.
“So if you’re walking down the hallway, and someone collapses and you offer assistance, even though you’re not the patient’s physician, in some states you’ll be covered by the Good Samaritan law,” Dr. Dunn said. “So it’s helpful to know your state’s laws.”
Good Samaritan assistance during commercial flights is governed by the federal Aviation Medical Assistance Act of 1998; the law protects providers who respond to in-flight medical emergencies against liability for negligence. Medical emergencies occur in about 1 of every 600 flights, and physicians assist in nearly half of these cases, according to a 2013 study (N Engl J Med. 2013 Aug 29;369[9]:877).
Pregnancy did not increase Hodgkin lymphoma relapse rate
Women who become pregnant while in remission from Hodgkin lymphoma were not at increased risk for cancer relapse, according to an analysis of data from Swedish health care registries combined with medical records.
Of 449 women who were diagnosed with Hodgkin lymphoma between 1992 and 2009, 144 (32%) became pregnant during follow-up, which started 6 months after diagnosis, when the disease was assumed to be in remission. Only one of these women experienced a pregnancy-associated relapse, which was defined as a relapse occurring during pregnancy or within 5 years of delivery. Of the women who did not become pregnant, 46 had a relapse.
The effect of pregnancy on relapse has been a concern of patients and clinicians, but “our findings suggest that the risk of pregnancy-associated relapse does not need to be taken into account in family planning for women whose Hodgkin lymphoma is in remission,” said Caroline E. Weibull of Karolinska Institutet in Stockholm, and her associates.
The researchers used the nationwide “Swedish Cancer Register” to identify all cases of Hodgkin lymphoma (reporting is mandatory) and merged this data with clinical information from other registries and medical records.
The pregnancy rates were similar among women who had limited- and advanced-stage disease and among women with and without B symptoms at diagnosis – a finding that negates consideration of a so-called “healthy mother effect” in protecting against relapse, they wrote (J Clin Onc. 2015 Dec. 14 [doi:10.1200/JCO.2015.63.3446]).
The researchers also found that the absolute risk for relapse was highest in the first 2-3 years after diagnosis, which suggests that women should be advised, “if possible, to wait 2 years after cessation of treatment before becoming pregnant.” Additionally, the relapse rate more than doubled in women aged 30 years or older at diagnosis, compared with women aged 18-24 years at diagnosis – a finding consistent with previous research, they noted.
Women in the study were aged 18-40 at diagnosis. Follow-up ended on the date of relapse, the date of death, or at the end of 2010, whichever came first.
Women who become pregnant while in remission from Hodgkin lymphoma were not at increased risk for cancer relapse, according to an analysis of data from Swedish health care registries combined with medical records.
Of 449 women who were diagnosed with Hodgkin lymphoma between 1992 and 2009, 144 (32%) became pregnant during follow-up, which started 6 months after diagnosis, when the disease was assumed to be in remission. Only one of these women experienced a pregnancy-associated relapse, which was defined as a relapse occurring during pregnancy or within 5 years of delivery. Of the women who did not become pregnant, 46 had a relapse.
The effect of pregnancy on relapse has been a concern of patients and clinicians, but “our findings suggest that the risk of pregnancy-associated relapse does not need to be taken into account in family planning for women whose Hodgkin lymphoma is in remission,” said Caroline E. Weibull of Karolinska Institutet in Stockholm, and her associates.
The researchers used the nationwide “Swedish Cancer Register” to identify all cases of Hodgkin lymphoma (reporting is mandatory) and merged this data with clinical information from other registries and medical records.
The pregnancy rates were similar among women who had limited- and advanced-stage disease and among women with and without B symptoms at diagnosis – a finding that negates consideration of a so-called “healthy mother effect” in protecting against relapse, they wrote (J Clin Onc. 2015 Dec. 14 [doi:10.1200/JCO.2015.63.3446]).
The researchers also found that the absolute risk for relapse was highest in the first 2-3 years after diagnosis, which suggests that women should be advised, “if possible, to wait 2 years after cessation of treatment before becoming pregnant.” Additionally, the relapse rate more than doubled in women aged 30 years or older at diagnosis, compared with women aged 18-24 years at diagnosis – a finding consistent with previous research, they noted.
Women in the study were aged 18-40 at diagnosis. Follow-up ended on the date of relapse, the date of death, or at the end of 2010, whichever came first.
Women who become pregnant while in remission from Hodgkin lymphoma were not at increased risk for cancer relapse, according to an analysis of data from Swedish health care registries combined with medical records.
Of 449 women who were diagnosed with Hodgkin lymphoma between 1992 and 2009, 144 (32%) became pregnant during follow-up, which started 6 months after diagnosis, when the disease was assumed to be in remission. Only one of these women experienced a pregnancy-associated relapse, which was defined as a relapse occurring during pregnancy or within 5 years of delivery. Of the women who did not become pregnant, 46 had a relapse.
The effect of pregnancy on relapse has been a concern of patients and clinicians, but “our findings suggest that the risk of pregnancy-associated relapse does not need to be taken into account in family planning for women whose Hodgkin lymphoma is in remission,” said Caroline E. Weibull of Karolinska Institutet in Stockholm, and her associates.
The researchers used the nationwide “Swedish Cancer Register” to identify all cases of Hodgkin lymphoma (reporting is mandatory) and merged this data with clinical information from other registries and medical records.
The pregnancy rates were similar among women who had limited- and advanced-stage disease and among women with and without B symptoms at diagnosis – a finding that negates consideration of a so-called “healthy mother effect” in protecting against relapse, they wrote (J Clin Onc. 2015 Dec. 14 [doi:10.1200/JCO.2015.63.3446]).
The researchers also found that the absolute risk for relapse was highest in the first 2-3 years after diagnosis, which suggests that women should be advised, “if possible, to wait 2 years after cessation of treatment before becoming pregnant.” Additionally, the relapse rate more than doubled in women aged 30 years or older at diagnosis, compared with women aged 18-24 years at diagnosis – a finding consistent with previous research, they noted.
Women in the study were aged 18-40 at diagnosis. Follow-up ended on the date of relapse, the date of death, or at the end of 2010, whichever came first.
FROM JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: Pregnancy did not increase the risk of relapse of Hodgkin lymphoma in a population-based study.
Major finding: Of 144 women who became pregnant 6 months or longer after diagnosis of Hodgkin lymphoma, 1 experienced a pregnancy-associated relapse.
Data source: Population-based study utilizing Swedish health care registries and medical records, in which 449 women with Hodgkin lymphoma diagnoses, and 47 relapses, were identified.
Disclosures: The study was supported by the Swedish Cancer Society, the Strategic Research Program in Epidemiology at Karolinska Institutet, the Swedish Society for Medicine, and the Swedish Society for Medical Research.
Changes in AAP periodicity schedule include several new screenings
An updated version of the American Academy of Pediatrics’ Recommendations for Preventive Pediatric Health Care, published in the January 2016 issue of Pediatrics, includes screening recommendations that may still be slow on the uptake in pediatric practices since being approved by the AAP 2 years ago.
Depression screening is “starting to improve,” but lipid screening and HIV screening have been “harder to implement,” said Dr. Geoffrey R. Simon, chair of the AAP’s Committee on Practice and Ambulatory Medicine, which works with the Bright Futures Periodicity Schedule Workgroup to keep the schedule up to date.
Publication of the schedule in Pediatrics (2016 Jan. doi: 10.1542/peds.2015-3908), as has been done every 3-5 years, is in many ways a formality this time around. Two years ago, the AAP began updating the schedule in real time to immediately reflect new recommendations and guidelines endorsed or produced by the Academy for comprehensive health supervision.
“The goal has been to shorten the time frame for incorporating new evidence, including removing screening items that research has demonstrated aren’t useful,” Dr. Simon, a pediatrician in Wilmington, Del., said in an interview.
Each of these screenings, however, like the other recommended services listed in the Periodicity Schedule, is backed by evidence and is required under the Affordable Care Act to be covered by insurers without any cost sharing. Other recommendations include a call for fluoride varnish applications from 6 months through 5 years.
“These aren’t just good ideas. There is strong evidence for [every recommendation] on the Periodicity Schedule,” Dr. Joseph F. Hagan Jr., a member of the Bright Futures Periodicity Schedule Workgroup and a pediatrician in Burlington, Vt., said in an interview.
The updated schedule no longer recommends vision screening at age 18 years, based on evidence showing that far fewer new vision problems develop in low-risk young adults as younger children. It also omits routine screening for cervical dysplasia until age 21 years.
The change from vision screening to risk-based assessment at age 18 coincides with publication – also in the January issue of Pediatrics – of an AAP policy statement on Visual System Assessment in Infants, Children, and Young Adults (Pediatrics. 2016 Jan. doi: 10.1542/peds.2015-35970.) and an accompanying clinical report titled Procedures for the Evaluation of the Visual System by Pediatricians (Pediatrics. 2016 Jan. doi: 10.1542/peds.2015-3597).
Screening for depression is recommended annually from ages 11-21 years, as suicide is now a leading cause of death among adolescents. And HIV screening is recommended for adolescents aged 16-18 years to address federal statistics showing that 1 in 4 new HIV infections occurs in youth aged 13-24 years, and that about 60% of all youth with HIV do not know they are infected, according to the AAP.
The recommendation for dyslipidemia screening covers patients aged 9-11 years, in addition to those aged 18-21 years. The recommendation to screen once during each of these two windows of times is based on guidelines from the National Heart, Lung, and Blood Institute on cardiovascular risk reduction in childhood and adolescence, Dr. Simon said.
“It was an attempt to make it easier and more effective by replacing an ineffective and cumbersome two-step screening process using risk assessment with lab testing if needed,” he said.
At the annual meeting of the AAP in October 2015, pediatric cardiologist Dr. Sarah de Ferranti said in a packed sessionon lipid screening that getting a family history of cardiovascular disease has proven unreliable for identifying children at high risk of disease – even those with familial hypercholesterolemia. This disorder affects 1 in 250 individuals, she said, and is usually “asymptomatic until individuals present in their young adulthood with a much higher risk of heart disease … or until they come to the ER as adults.”
Dr. Karalyn Kinsella, a pediatrician in Cheshire, Conn., is among those pediatricians who have found lipid screening and HIV screening to be particularly challenging. “The difficulty [with lipid screening in my practice] is with those children who are already physically active, have healthy diets, and a normal BMI,” said Dr. Kinsella, who was asked to comment on the current periodicity schedule. “When they have elevated lipid levels, what is our next step? For those not high enough to treat, it can create unnecessary anxiety in families.”
With respect to HIV screening, payment issues can impede confidentiality. “We’re obligated to maintain confidentiality with the teen, but parents sometimes see the bill,” she said, adding that many her adolescents’ families “have health savings accounts with high deductibles and have to pay out of pocket.”
Coverage of point-of-care testing still is inadequate, Dr. Simon said. “It’s a payer barrier to delivering care in a timely manner,” he said.
Another recommendation made in 2014 and reflected in the newly published schedule advises pediatricians to use the CRAFFT (Car, Relax, Forget, Friends, Trouble) screening questionnaire as a tool to screen adolescents for drug and alcohol use. Specific tools are not usually recommended, Dr. Hagan said, but the CRAFFT screen “is validated and has been sufficiently widely used that we recommend it.”
One challenge, Dr. Kinsella said, is allowing enough time for the teen patient to fill out two screens – CRAFFT and a depression screening tool. “Ideally,” she added, “patients could fill them out on an [EHR] patient portal,” with confidentiality ensured.
The upcoming revised edition of the Bright Futures Guidelines for Health Supervision of Infants, Children, and Adolescents – expected in late spring or early summer of 2016 – will offer more guidance on previsit screening, which is valuable because “it moves some of this time away from the [limited] face-to-face time that you have, so you know where to focus your time in the visit,” said Dr. Hagan, coeditor of Bright Futures.
“We’re looking at making these visits efficient, efficacious, and most importantly, doable,” he emphasized.
The 4th edition of Bright Futures will include another freshly updated periodicity schedule that likely will include maternal depression screening and a recommendation for developmental screening at 4 years, as well as an expanded window for HIV testing from the current 16-18 years to 15-21 years, said Dr. Hagan, who previewed the new edition at the AAP annual meeting.
As Bright Futures and the Committee on Practice and Ambulatory Medicine deliberate these potential additions to the schedule, “we [will consider] how much these screening recommendations can impact and improve child health, and if a busy pediatrician can perform them in a time and cost-effective manner,” Dr. Simon said.
An up-to-date periodicity schedule can be accessed here.
An updated version of the American Academy of Pediatrics’ Recommendations for Preventive Pediatric Health Care, published in the January 2016 issue of Pediatrics, includes screening recommendations that may still be slow on the uptake in pediatric practices since being approved by the AAP 2 years ago.
Depression screening is “starting to improve,” but lipid screening and HIV screening have been “harder to implement,” said Dr. Geoffrey R. Simon, chair of the AAP’s Committee on Practice and Ambulatory Medicine, which works with the Bright Futures Periodicity Schedule Workgroup to keep the schedule up to date.
Publication of the schedule in Pediatrics (2016 Jan. doi: 10.1542/peds.2015-3908), as has been done every 3-5 years, is in many ways a formality this time around. Two years ago, the AAP began updating the schedule in real time to immediately reflect new recommendations and guidelines endorsed or produced by the Academy for comprehensive health supervision.
“The goal has been to shorten the time frame for incorporating new evidence, including removing screening items that research has demonstrated aren’t useful,” Dr. Simon, a pediatrician in Wilmington, Del., said in an interview.
Each of these screenings, however, like the other recommended services listed in the Periodicity Schedule, is backed by evidence and is required under the Affordable Care Act to be covered by insurers without any cost sharing. Other recommendations include a call for fluoride varnish applications from 6 months through 5 years.
“These aren’t just good ideas. There is strong evidence for [every recommendation] on the Periodicity Schedule,” Dr. Joseph F. Hagan Jr., a member of the Bright Futures Periodicity Schedule Workgroup and a pediatrician in Burlington, Vt., said in an interview.
The updated schedule no longer recommends vision screening at age 18 years, based on evidence showing that far fewer new vision problems develop in low-risk young adults as younger children. It also omits routine screening for cervical dysplasia until age 21 years.
The change from vision screening to risk-based assessment at age 18 coincides with publication – also in the January issue of Pediatrics – of an AAP policy statement on Visual System Assessment in Infants, Children, and Young Adults (Pediatrics. 2016 Jan. doi: 10.1542/peds.2015-35970.) and an accompanying clinical report titled Procedures for the Evaluation of the Visual System by Pediatricians (Pediatrics. 2016 Jan. doi: 10.1542/peds.2015-3597).
Screening for depression is recommended annually from ages 11-21 years, as suicide is now a leading cause of death among adolescents. And HIV screening is recommended for adolescents aged 16-18 years to address federal statistics showing that 1 in 4 new HIV infections occurs in youth aged 13-24 years, and that about 60% of all youth with HIV do not know they are infected, according to the AAP.
The recommendation for dyslipidemia screening covers patients aged 9-11 years, in addition to those aged 18-21 years. The recommendation to screen once during each of these two windows of times is based on guidelines from the National Heart, Lung, and Blood Institute on cardiovascular risk reduction in childhood and adolescence, Dr. Simon said.
“It was an attempt to make it easier and more effective by replacing an ineffective and cumbersome two-step screening process using risk assessment with lab testing if needed,” he said.
At the annual meeting of the AAP in October 2015, pediatric cardiologist Dr. Sarah de Ferranti said in a packed sessionon lipid screening that getting a family history of cardiovascular disease has proven unreliable for identifying children at high risk of disease – even those with familial hypercholesterolemia. This disorder affects 1 in 250 individuals, she said, and is usually “asymptomatic until individuals present in their young adulthood with a much higher risk of heart disease … or until they come to the ER as adults.”
Dr. Karalyn Kinsella, a pediatrician in Cheshire, Conn., is among those pediatricians who have found lipid screening and HIV screening to be particularly challenging. “The difficulty [with lipid screening in my practice] is with those children who are already physically active, have healthy diets, and a normal BMI,” said Dr. Kinsella, who was asked to comment on the current periodicity schedule. “When they have elevated lipid levels, what is our next step? For those not high enough to treat, it can create unnecessary anxiety in families.”
With respect to HIV screening, payment issues can impede confidentiality. “We’re obligated to maintain confidentiality with the teen, but parents sometimes see the bill,” she said, adding that many her adolescents’ families “have health savings accounts with high deductibles and have to pay out of pocket.”
Coverage of point-of-care testing still is inadequate, Dr. Simon said. “It’s a payer barrier to delivering care in a timely manner,” he said.
Another recommendation made in 2014 and reflected in the newly published schedule advises pediatricians to use the CRAFFT (Car, Relax, Forget, Friends, Trouble) screening questionnaire as a tool to screen adolescents for drug and alcohol use. Specific tools are not usually recommended, Dr. Hagan said, but the CRAFFT screen “is validated and has been sufficiently widely used that we recommend it.”
One challenge, Dr. Kinsella said, is allowing enough time for the teen patient to fill out two screens – CRAFFT and a depression screening tool. “Ideally,” she added, “patients could fill them out on an [EHR] patient portal,” with confidentiality ensured.
The upcoming revised edition of the Bright Futures Guidelines for Health Supervision of Infants, Children, and Adolescents – expected in late spring or early summer of 2016 – will offer more guidance on previsit screening, which is valuable because “it moves some of this time away from the [limited] face-to-face time that you have, so you know where to focus your time in the visit,” said Dr. Hagan, coeditor of Bright Futures.
“We’re looking at making these visits efficient, efficacious, and most importantly, doable,” he emphasized.
The 4th edition of Bright Futures will include another freshly updated periodicity schedule that likely will include maternal depression screening and a recommendation for developmental screening at 4 years, as well as an expanded window for HIV testing from the current 16-18 years to 15-21 years, said Dr. Hagan, who previewed the new edition at the AAP annual meeting.
As Bright Futures and the Committee on Practice and Ambulatory Medicine deliberate these potential additions to the schedule, “we [will consider] how much these screening recommendations can impact and improve child health, and if a busy pediatrician can perform them in a time and cost-effective manner,” Dr. Simon said.
An up-to-date periodicity schedule can be accessed here.
An updated version of the American Academy of Pediatrics’ Recommendations for Preventive Pediatric Health Care, published in the January 2016 issue of Pediatrics, includes screening recommendations that may still be slow on the uptake in pediatric practices since being approved by the AAP 2 years ago.
Depression screening is “starting to improve,” but lipid screening and HIV screening have been “harder to implement,” said Dr. Geoffrey R. Simon, chair of the AAP’s Committee on Practice and Ambulatory Medicine, which works with the Bright Futures Periodicity Schedule Workgroup to keep the schedule up to date.
Publication of the schedule in Pediatrics (2016 Jan. doi: 10.1542/peds.2015-3908), as has been done every 3-5 years, is in many ways a formality this time around. Two years ago, the AAP began updating the schedule in real time to immediately reflect new recommendations and guidelines endorsed or produced by the Academy for comprehensive health supervision.
“The goal has been to shorten the time frame for incorporating new evidence, including removing screening items that research has demonstrated aren’t useful,” Dr. Simon, a pediatrician in Wilmington, Del., said in an interview.
Each of these screenings, however, like the other recommended services listed in the Periodicity Schedule, is backed by evidence and is required under the Affordable Care Act to be covered by insurers without any cost sharing. Other recommendations include a call for fluoride varnish applications from 6 months through 5 years.
“These aren’t just good ideas. There is strong evidence for [every recommendation] on the Periodicity Schedule,” Dr. Joseph F. Hagan Jr., a member of the Bright Futures Periodicity Schedule Workgroup and a pediatrician in Burlington, Vt., said in an interview.
The updated schedule no longer recommends vision screening at age 18 years, based on evidence showing that far fewer new vision problems develop in low-risk young adults as younger children. It also omits routine screening for cervical dysplasia until age 21 years.
The change from vision screening to risk-based assessment at age 18 coincides with publication – also in the January issue of Pediatrics – of an AAP policy statement on Visual System Assessment in Infants, Children, and Young Adults (Pediatrics. 2016 Jan. doi: 10.1542/peds.2015-35970.) and an accompanying clinical report titled Procedures for the Evaluation of the Visual System by Pediatricians (Pediatrics. 2016 Jan. doi: 10.1542/peds.2015-3597).
Screening for depression is recommended annually from ages 11-21 years, as suicide is now a leading cause of death among adolescents. And HIV screening is recommended for adolescents aged 16-18 years to address federal statistics showing that 1 in 4 new HIV infections occurs in youth aged 13-24 years, and that about 60% of all youth with HIV do not know they are infected, according to the AAP.
The recommendation for dyslipidemia screening covers patients aged 9-11 years, in addition to those aged 18-21 years. The recommendation to screen once during each of these two windows of times is based on guidelines from the National Heart, Lung, and Blood Institute on cardiovascular risk reduction in childhood and adolescence, Dr. Simon said.
“It was an attempt to make it easier and more effective by replacing an ineffective and cumbersome two-step screening process using risk assessment with lab testing if needed,” he said.
At the annual meeting of the AAP in October 2015, pediatric cardiologist Dr. Sarah de Ferranti said in a packed sessionon lipid screening that getting a family history of cardiovascular disease has proven unreliable for identifying children at high risk of disease – even those with familial hypercholesterolemia. This disorder affects 1 in 250 individuals, she said, and is usually “asymptomatic until individuals present in their young adulthood with a much higher risk of heart disease … or until they come to the ER as adults.”
Dr. Karalyn Kinsella, a pediatrician in Cheshire, Conn., is among those pediatricians who have found lipid screening and HIV screening to be particularly challenging. “The difficulty [with lipid screening in my practice] is with those children who are already physically active, have healthy diets, and a normal BMI,” said Dr. Kinsella, who was asked to comment on the current periodicity schedule. “When they have elevated lipid levels, what is our next step? For those not high enough to treat, it can create unnecessary anxiety in families.”
With respect to HIV screening, payment issues can impede confidentiality. “We’re obligated to maintain confidentiality with the teen, but parents sometimes see the bill,” she said, adding that many her adolescents’ families “have health savings accounts with high deductibles and have to pay out of pocket.”
Coverage of point-of-care testing still is inadequate, Dr. Simon said. “It’s a payer barrier to delivering care in a timely manner,” he said.
Another recommendation made in 2014 and reflected in the newly published schedule advises pediatricians to use the CRAFFT (Car, Relax, Forget, Friends, Trouble) screening questionnaire as a tool to screen adolescents for drug and alcohol use. Specific tools are not usually recommended, Dr. Hagan said, but the CRAFFT screen “is validated and has been sufficiently widely used that we recommend it.”
One challenge, Dr. Kinsella said, is allowing enough time for the teen patient to fill out two screens – CRAFFT and a depression screening tool. “Ideally,” she added, “patients could fill them out on an [EHR] patient portal,” with confidentiality ensured.
The upcoming revised edition of the Bright Futures Guidelines for Health Supervision of Infants, Children, and Adolescents – expected in late spring or early summer of 2016 – will offer more guidance on previsit screening, which is valuable because “it moves some of this time away from the [limited] face-to-face time that you have, so you know where to focus your time in the visit,” said Dr. Hagan, coeditor of Bright Futures.
“We’re looking at making these visits efficient, efficacious, and most importantly, doable,” he emphasized.
The 4th edition of Bright Futures will include another freshly updated periodicity schedule that likely will include maternal depression screening and a recommendation for developmental screening at 4 years, as well as an expanded window for HIV testing from the current 16-18 years to 15-21 years, said Dr. Hagan, who previewed the new edition at the AAP annual meeting.
As Bright Futures and the Committee on Practice and Ambulatory Medicine deliberate these potential additions to the schedule, “we [will consider] how much these screening recommendations can impact and improve child health, and if a busy pediatrician can perform them in a time and cost-effective manner,” Dr. Simon said.
An up-to-date periodicity schedule can be accessed here.
FROM PEDIATRICS
AAP: New Bright Futures edition coming with added screenings
WASHINGTON – A new edition of the Bright Futures guidelines is scheduled for release in 2016, and among the expected changes are a recommendation for developmental screening at 4 years and an increased emphasis on the “social determinants of health.”
Revisions planned for the 4th edition of the Bright Futures Health Supervision Guidelines for Infants, Children, and Adolescents, including the American Academy of Pediatrics Periodicity Schedule, are notable not only because they reflect new evidence, but because the services recommended in the guidelines are required by the Affordable Care Act to be covered by insurers without any cost sharing, Dr. Joseph F. Hagan Jr., a pediatrician in Burlington, Vt., and coeditor of Bright Futures, said at the annual meeting of the American Academy of Pediatrics.
The current Recommendations for Preventive Pediatric Health Care – Periodicity Schedule – which represents a consensus of the Bright Futures advisory committee and the AAP – recommends standardized developmental screening at ages 9, 18, and 30 months, and autism screening at ages 18 and 24 months.
The expected addition of developmental screening to the 4-year health supervision visit will be in keeping with the tools most often utilized in pediatric practices, such as the Ages & Stages Questionnaires, which are validated for screening in children up to 5 years of age. “A lot can happen in 18 months [since the 30-month visit],” Dr. Hagan said.
In 2015 the U.S. Preventive Services Task Force assigned a “I” evidence rating to screening for speech and language delays and disorders in children aged 5 and younger, which means it found insufficient evidence to recommend for or against screening. Still, developmental screening meets a minimum standard for Bright Futures of being “evidence informed” in its recommendations for services and screening, Dr. Hagan said.
“We have tried to provide at least evidence-informed recommendations for the content each of the 31 visits you provide from birth to age 21,” he emphasized. Evidence was “important in the 3rd edition and it’s essential in the 4th. We must have a strong evidence base when we make a recommendation for something new that insurance companies will need to pay for.”
Outside of the Periodicity Schedule, Bright Futures offers recommendations for health promotion and anticipatory guidance, and some of these recommendations are consensus based rather than evidence based or evidence informed. However, a lack of evidence “doesn’t necessarily mean lack of efficacy,” he said at the meeting. “It usually reflects a lack of study in children.”
The updated guidelines – which, like previous versions, have been funded by the U.S. Department of Health and Human Services and will be published by the AAP – will include an expanded chapter on rationale and evidence for each recommendation so that “you can see transparently what we chose and why,” Dr. Hagan told this newspaper.
The social components of health have been a core component of the Bright Futures guidelines since their inception in 1994, but the upcoming 4th edition will more specifically incorporate social determinants of health as a visit priority for most of the recommended health supervision visits, he said.
Some of the other expected changes to Bright Futures address the following areas:
• Motor screening. Recommended developmental surveillance in the updated Bright Futures guidelines will for the first time include evaluation for motor delays, the importance of which was described in a 2013 AAP clinical report (Pediatrics. 2013 Jun;131[6]:e2016-27).
• Maternal depression screening. This was included in the 3rd edition as a selective screen, and was recommended by the AAP in a 2010 clinical report on recognition and management of perinatal and postpartum depression (Pediatrics. 2010 Nov;126[5]:1032-9). Finalization of a draft USPSTF statement recommending depression screening in mothers will give Bright Futures and the AAP the evidence it needs to incorporate this screening into the periodicity schedule.
• Safe sleep. Sleep in the parents’ room “for at least 6 months” will be recommended, as well as a move away from swaddling by 2 months of age. The latter is based on consensus opinion. “There’s no evidence, but there’s concern about safety [of swaddling],” Dr. Hagan said. “By the 1-month visit, we should be encouraging parents not to swaddle for sleep.”
• Iron supplementation. The AAP recommended in 2011 that exclusively breastfed infants should receive an iron supplement starting at 4 months, and the 4th edition of Bright Futures will highlight this. And as a reflection of “current best thinking,” the new edition will recommend advising parents that meat is a better source of iron than iron-fortified cereal. “We want to move it earlier in the nutritional schema,” Dr. Hagan said.
• Fluoride varnish. This procedure was integrated into the Periodicity Schedule in September 2015, with a recommendation from 6 months through 5 years of age, after having received a B-level recommendation by the USPSTF in 2014. The new Bright Futures edition will provide detail and guidance on this oral health service.
• HIV screening. The recommended window for universal one-time screening will be expanded from 16-18 years to 15-21 years, with the current recommendation for annual selective screening and an opt-out option remaining as is. The new window will be more consistent with recommendations of the Centers for Disease Control and Prevention and will better cover the middle-adolescent period of 15-17 years of age, Dr. Hagan said.
WASHINGTON – A new edition of the Bright Futures guidelines is scheduled for release in 2016, and among the expected changes are a recommendation for developmental screening at 4 years and an increased emphasis on the “social determinants of health.”
Revisions planned for the 4th edition of the Bright Futures Health Supervision Guidelines for Infants, Children, and Adolescents, including the American Academy of Pediatrics Periodicity Schedule, are notable not only because they reflect new evidence, but because the services recommended in the guidelines are required by the Affordable Care Act to be covered by insurers without any cost sharing, Dr. Joseph F. Hagan Jr., a pediatrician in Burlington, Vt., and coeditor of Bright Futures, said at the annual meeting of the American Academy of Pediatrics.
The current Recommendations for Preventive Pediatric Health Care – Periodicity Schedule – which represents a consensus of the Bright Futures advisory committee and the AAP – recommends standardized developmental screening at ages 9, 18, and 30 months, and autism screening at ages 18 and 24 months.
The expected addition of developmental screening to the 4-year health supervision visit will be in keeping with the tools most often utilized in pediatric practices, such as the Ages & Stages Questionnaires, which are validated for screening in children up to 5 years of age. “A lot can happen in 18 months [since the 30-month visit],” Dr. Hagan said.
In 2015 the U.S. Preventive Services Task Force assigned a “I” evidence rating to screening for speech and language delays and disorders in children aged 5 and younger, which means it found insufficient evidence to recommend for or against screening. Still, developmental screening meets a minimum standard for Bright Futures of being “evidence informed” in its recommendations for services and screening, Dr. Hagan said.
“We have tried to provide at least evidence-informed recommendations for the content each of the 31 visits you provide from birth to age 21,” he emphasized. Evidence was “important in the 3rd edition and it’s essential in the 4th. We must have a strong evidence base when we make a recommendation for something new that insurance companies will need to pay for.”
Outside of the Periodicity Schedule, Bright Futures offers recommendations for health promotion and anticipatory guidance, and some of these recommendations are consensus based rather than evidence based or evidence informed. However, a lack of evidence “doesn’t necessarily mean lack of efficacy,” he said at the meeting. “It usually reflects a lack of study in children.”
The updated guidelines – which, like previous versions, have been funded by the U.S. Department of Health and Human Services and will be published by the AAP – will include an expanded chapter on rationale and evidence for each recommendation so that “you can see transparently what we chose and why,” Dr. Hagan told this newspaper.
The social components of health have been a core component of the Bright Futures guidelines since their inception in 1994, but the upcoming 4th edition will more specifically incorporate social determinants of health as a visit priority for most of the recommended health supervision visits, he said.
Some of the other expected changes to Bright Futures address the following areas:
• Motor screening. Recommended developmental surveillance in the updated Bright Futures guidelines will for the first time include evaluation for motor delays, the importance of which was described in a 2013 AAP clinical report (Pediatrics. 2013 Jun;131[6]:e2016-27).
• Maternal depression screening. This was included in the 3rd edition as a selective screen, and was recommended by the AAP in a 2010 clinical report on recognition and management of perinatal and postpartum depression (Pediatrics. 2010 Nov;126[5]:1032-9). Finalization of a draft USPSTF statement recommending depression screening in mothers will give Bright Futures and the AAP the evidence it needs to incorporate this screening into the periodicity schedule.
• Safe sleep. Sleep in the parents’ room “for at least 6 months” will be recommended, as well as a move away from swaddling by 2 months of age. The latter is based on consensus opinion. “There’s no evidence, but there’s concern about safety [of swaddling],” Dr. Hagan said. “By the 1-month visit, we should be encouraging parents not to swaddle for sleep.”
• Iron supplementation. The AAP recommended in 2011 that exclusively breastfed infants should receive an iron supplement starting at 4 months, and the 4th edition of Bright Futures will highlight this. And as a reflection of “current best thinking,” the new edition will recommend advising parents that meat is a better source of iron than iron-fortified cereal. “We want to move it earlier in the nutritional schema,” Dr. Hagan said.
• Fluoride varnish. This procedure was integrated into the Periodicity Schedule in September 2015, with a recommendation from 6 months through 5 years of age, after having received a B-level recommendation by the USPSTF in 2014. The new Bright Futures edition will provide detail and guidance on this oral health service.
• HIV screening. The recommended window for universal one-time screening will be expanded from 16-18 years to 15-21 years, with the current recommendation for annual selective screening and an opt-out option remaining as is. The new window will be more consistent with recommendations of the Centers for Disease Control and Prevention and will better cover the middle-adolescent period of 15-17 years of age, Dr. Hagan said.
WASHINGTON – A new edition of the Bright Futures guidelines is scheduled for release in 2016, and among the expected changes are a recommendation for developmental screening at 4 years and an increased emphasis on the “social determinants of health.”
Revisions planned for the 4th edition of the Bright Futures Health Supervision Guidelines for Infants, Children, and Adolescents, including the American Academy of Pediatrics Periodicity Schedule, are notable not only because they reflect new evidence, but because the services recommended in the guidelines are required by the Affordable Care Act to be covered by insurers without any cost sharing, Dr. Joseph F. Hagan Jr., a pediatrician in Burlington, Vt., and coeditor of Bright Futures, said at the annual meeting of the American Academy of Pediatrics.
The current Recommendations for Preventive Pediatric Health Care – Periodicity Schedule – which represents a consensus of the Bright Futures advisory committee and the AAP – recommends standardized developmental screening at ages 9, 18, and 30 months, and autism screening at ages 18 and 24 months.
The expected addition of developmental screening to the 4-year health supervision visit will be in keeping with the tools most often utilized in pediatric practices, such as the Ages & Stages Questionnaires, which are validated for screening in children up to 5 years of age. “A lot can happen in 18 months [since the 30-month visit],” Dr. Hagan said.
In 2015 the U.S. Preventive Services Task Force assigned a “I” evidence rating to screening for speech and language delays and disorders in children aged 5 and younger, which means it found insufficient evidence to recommend for or against screening. Still, developmental screening meets a minimum standard for Bright Futures of being “evidence informed” in its recommendations for services and screening, Dr. Hagan said.
“We have tried to provide at least evidence-informed recommendations for the content each of the 31 visits you provide from birth to age 21,” he emphasized. Evidence was “important in the 3rd edition and it’s essential in the 4th. We must have a strong evidence base when we make a recommendation for something new that insurance companies will need to pay for.”
Outside of the Periodicity Schedule, Bright Futures offers recommendations for health promotion and anticipatory guidance, and some of these recommendations are consensus based rather than evidence based or evidence informed. However, a lack of evidence “doesn’t necessarily mean lack of efficacy,” he said at the meeting. “It usually reflects a lack of study in children.”
The updated guidelines – which, like previous versions, have been funded by the U.S. Department of Health and Human Services and will be published by the AAP – will include an expanded chapter on rationale and evidence for each recommendation so that “you can see transparently what we chose and why,” Dr. Hagan told this newspaper.
The social components of health have been a core component of the Bright Futures guidelines since their inception in 1994, but the upcoming 4th edition will more specifically incorporate social determinants of health as a visit priority for most of the recommended health supervision visits, he said.
Some of the other expected changes to Bright Futures address the following areas:
• Motor screening. Recommended developmental surveillance in the updated Bright Futures guidelines will for the first time include evaluation for motor delays, the importance of which was described in a 2013 AAP clinical report (Pediatrics. 2013 Jun;131[6]:e2016-27).
• Maternal depression screening. This was included in the 3rd edition as a selective screen, and was recommended by the AAP in a 2010 clinical report on recognition and management of perinatal and postpartum depression (Pediatrics. 2010 Nov;126[5]:1032-9). Finalization of a draft USPSTF statement recommending depression screening in mothers will give Bright Futures and the AAP the evidence it needs to incorporate this screening into the periodicity schedule.
• Safe sleep. Sleep in the parents’ room “for at least 6 months” will be recommended, as well as a move away from swaddling by 2 months of age. The latter is based on consensus opinion. “There’s no evidence, but there’s concern about safety [of swaddling],” Dr. Hagan said. “By the 1-month visit, we should be encouraging parents not to swaddle for sleep.”
• Iron supplementation. The AAP recommended in 2011 that exclusively breastfed infants should receive an iron supplement starting at 4 months, and the 4th edition of Bright Futures will highlight this. And as a reflection of “current best thinking,” the new edition will recommend advising parents that meat is a better source of iron than iron-fortified cereal. “We want to move it earlier in the nutritional schema,” Dr. Hagan said.
• Fluoride varnish. This procedure was integrated into the Periodicity Schedule in September 2015, with a recommendation from 6 months through 5 years of age, after having received a B-level recommendation by the USPSTF in 2014. The new Bright Futures edition will provide detail and guidance on this oral health service.
• HIV screening. The recommended window for universal one-time screening will be expanded from 16-18 years to 15-21 years, with the current recommendation for annual selective screening and an opt-out option remaining as is. The new window will be more consistent with recommendations of the Centers for Disease Control and Prevention and will better cover the middle-adolescent period of 15-17 years of age, Dr. Hagan said.
EXPERT ANALYSIS FROM THE AAP ANNUAL MEETING
AAP: Fluoride varnish is billable and implementable
WASHINGTON – With fluoride varnish treatments now on the Bright Futures periodicity schedule, reimbursement is attainable, and pediatricians can focus on integrating the 45- to 60-second procedure into their practices and strengthening their oral health messaging to families.
Pediatrician Melinda Clark and pediatric dentist Rocio B. Quiñonez teamed up at the annual meeting of the American Academy of Pediatrics to deliver this message and to show pediatricians through a hands-on workshop how simple and important fluoride varnishing and oral health counseling are to pediatric preventive care.
“We have to own a part of this,” said Dr. Clark of the Albany (N.Y.) Medical Center Pediatric Group. With the dental community overloaded and dental caries the most common chronic childhood disease, “we cannot just cut out the teeth from our medical prevention paradigm.”
Dental caries is five times more common than asthma and seven times more common than hay fever. One in four children begin kindergarten with a history of early childhood caries, and children with the disease are three times as likely to miss school. The disease can progress to local infections, systemic infection, and in rare cases, death.
In 2014, the U.S. Preventive Services Task Force (USPSTF) recommended that primary care clinicians apply fluoride varnish to the primary teeth of all infants and children starting at the age of primary tooth eruption. The USPSTF did not specifically recommend the frequency of application, but in a clinical report published later in 2014 on “Fluoride Use in Caries Prevention in the Primary Care Setting,” the American Academy of Pediatrics recommended fluoride varnish at least once every 6 months – and preferably every 3 months – starting at tooth emergence (Pediatrics. 2014 Sep;134[3]:626-33).
And in September 2015, fluoride varnish was added to the Bright Futures Guidelines for Health Supervision of Infants, Children, and Adolescents and integrated into the Bright Futures–AAP periodicity schedule.
Both the B recommendation given by the USPSTF to fluoride varnish application and inclusion in the Bright Futures periodicity schedule mean that it is required by the Affordable Care Act to be covered by insurers without out of pocket costs to the patient. Currently, 49 states are reimbursing physicians for fluoride varnish in the Medicaid population.
“It’s become the standard of care,” said Dr. Quiñonez of the division of pediatric dentistry at the University of North Carolina at Chapel Hill.
Fluoride varnish is a concentrated topical fluoride that sets on contact with saliva and helps prevent caries by enhancing remineralization and inhibiting bacterial enzymes. It has been shown to reduce decay by 30%-63%, depending on whether it is coupled with dental health counseling. The treatment has its greatest effect when applied before the onset of caries, but it also may help halt or reverse early carious lesions, which present as decalcified “white spot lesions” along the gum line.
“We have months, often times many months, to prevent disease and to intervene in the earliest stages [of childhood caries] … before children end up in the hospital or operating room,” said Dr. Clark, a former member of the AAP’s Section on Oral Health Executive Committee and a lead author of the AAP’s report on fluoride use.
She advised taking a systematic approach to applying the varnish. “I often apply it by arches [upper and lower, one dab per arch], as opposed to quadrants,” she said. “As long as you’re painting all the surfaces of every tooth with a thin layer of fluoride varnish, it’s an incredibly safe and effective procedure.”
“And you’ll get good at keeping the tongue out of the way using the gauze,” she said.
Varnish is best applied in infants and toddlers in a knee-to-knee format [provider-to-parent] with the child facing the parent and holding the parent’s hands, and the provider tipping the child into his or her lap. The teeth are dried first with a 2-inch gauze square. The fluoride is painted on with a brush provided with the varnish. Dr. Clark uses a head lamp as a light source so she has full use of both hands. Some providers use a dental mirror to increase visibility, but “I don’t find this necessary for most young children,” she said.
Questions about the safety of fluoride overall and fluoride varnish specifically “will come up” during discussions of oral health, Dr. Clark said. The only scientifically proven risk of fluoride is the development of fluorosis, which may occur if too much fluoride is ingested during the period of tooth and bone development, she said.
The small rise in plasma fluoride levels that can follow an application of fluoride varnish is comparable to ingesting a 1 mg fluoride tablet or brushing with fluoridated toothpaste, Dr. Clark said. Parents should be instructed not to brush the child’s teeth that evening or give any fluoride supplementation that day, if supplements are being used.
Not brushing teeth until the next morning also allows the varnish to stay on and continue depositing fluoride, she said. The child may eat, drink, and use a pacifier immediately after a varnish application. Hot, sticky, and crunchy foods should be avoided the same day.
The only contraindications to fluoride varnish are allergy to colophony/pine rosin, allergy to pine nuts, and ulcerative gingivitis/stomatitis or other open lesions. There are only three cases in the literature of side effects: one case of contact dermatitis and two cases of stomatitis. Colophony-free versions of fluoride varnish are available, Dr. Clark said.
Fluoride varnish is approved by the Food and Drug Administration as a cavity liner – not as a cavity prevention agent – but more than 110 studies and 40 clinical trials have documented its safety and effectiveness for cavity prevention, Dr. Clark reported. The 0.25 ml dose of varnish, which costs between $1 and $2, is the appropriate dose for children aged 4 years and under.Fluoride varnish is part of a bigger picture of oral health care in pediatrics – one that, first and foremost, involves “routinely asking if your patients have a dental home,” Dr. Clark said. The effectiveness of fluoride varnish is enhanced by regular discussions of oral health and counseling about risk factors for early childhood caries, such as frequent snacking and continual bottle or sippy cup use with fluid other than water.
Both Dr. Clark and Dr. Quiñonez urged pediatricians to take advantage of the parallels between obesity prevention and early childhood caries prevention nutritional messages (such as the risks of frequent juice and soda). And Dr. Clark suggested talking about bacteria and not just hygiene. “It sounds better to blame the evil bacteria than it does to blame poor hygiene, and that’s fine,” she said. “We can talk about how we’re going to keep the bacteria at bay.”
Dr. Quiñonez pointed out that children who were born premature or with low birth weights tend to have a higher prevalence of enamel defects and therefore are at greater risk of developing early childhood caries.
The AAP successfully advocated that fluoride varnish application be reimbursed as a separately reported service with use of the medical CPT code 99188. Use of the code to report fluoride varnish application by a physician or other qualified health professional took effect in January 2015. In some states, the dental code D1206 has been used with a V modifier specific to prophylactic fluoride administration for reimbursement through Medicaid and managed care. The modifier for use in ICD-10 is Z41.8.
“I’m in New York state, and we’ve been reimbursed $30 per fluoride varnish application (since 2009), and this includes risk assessment and counseling,” said Dr. Clark. “Some states pay in the single digits, and some pay in the high $50s.”
State by state information on payment and a host of practice tools and information on fluoride, fluoride varnish, and oral health risk assessment and counseling are available at the AAP’s Oral Health website. The site also provides links to each state’s AAP Chapter Oral Health Advocate who provides or coordinates education and training.
WASHINGTON – With fluoride varnish treatments now on the Bright Futures periodicity schedule, reimbursement is attainable, and pediatricians can focus on integrating the 45- to 60-second procedure into their practices and strengthening their oral health messaging to families.
Pediatrician Melinda Clark and pediatric dentist Rocio B. Quiñonez teamed up at the annual meeting of the American Academy of Pediatrics to deliver this message and to show pediatricians through a hands-on workshop how simple and important fluoride varnishing and oral health counseling are to pediatric preventive care.
“We have to own a part of this,” said Dr. Clark of the Albany (N.Y.) Medical Center Pediatric Group. With the dental community overloaded and dental caries the most common chronic childhood disease, “we cannot just cut out the teeth from our medical prevention paradigm.”
Dental caries is five times more common than asthma and seven times more common than hay fever. One in four children begin kindergarten with a history of early childhood caries, and children with the disease are three times as likely to miss school. The disease can progress to local infections, systemic infection, and in rare cases, death.
In 2014, the U.S. Preventive Services Task Force (USPSTF) recommended that primary care clinicians apply fluoride varnish to the primary teeth of all infants and children starting at the age of primary tooth eruption. The USPSTF did not specifically recommend the frequency of application, but in a clinical report published later in 2014 on “Fluoride Use in Caries Prevention in the Primary Care Setting,” the American Academy of Pediatrics recommended fluoride varnish at least once every 6 months – and preferably every 3 months – starting at tooth emergence (Pediatrics. 2014 Sep;134[3]:626-33).
And in September 2015, fluoride varnish was added to the Bright Futures Guidelines for Health Supervision of Infants, Children, and Adolescents and integrated into the Bright Futures–AAP periodicity schedule.
Both the B recommendation given by the USPSTF to fluoride varnish application and inclusion in the Bright Futures periodicity schedule mean that it is required by the Affordable Care Act to be covered by insurers without out of pocket costs to the patient. Currently, 49 states are reimbursing physicians for fluoride varnish in the Medicaid population.
“It’s become the standard of care,” said Dr. Quiñonez of the division of pediatric dentistry at the University of North Carolina at Chapel Hill.
Fluoride varnish is a concentrated topical fluoride that sets on contact with saliva and helps prevent caries by enhancing remineralization and inhibiting bacterial enzymes. It has been shown to reduce decay by 30%-63%, depending on whether it is coupled with dental health counseling. The treatment has its greatest effect when applied before the onset of caries, but it also may help halt or reverse early carious lesions, which present as decalcified “white spot lesions” along the gum line.
“We have months, often times many months, to prevent disease and to intervene in the earliest stages [of childhood caries] … before children end up in the hospital or operating room,” said Dr. Clark, a former member of the AAP’s Section on Oral Health Executive Committee and a lead author of the AAP’s report on fluoride use.
She advised taking a systematic approach to applying the varnish. “I often apply it by arches [upper and lower, one dab per arch], as opposed to quadrants,” she said. “As long as you’re painting all the surfaces of every tooth with a thin layer of fluoride varnish, it’s an incredibly safe and effective procedure.”
“And you’ll get good at keeping the tongue out of the way using the gauze,” she said.
Varnish is best applied in infants and toddlers in a knee-to-knee format [provider-to-parent] with the child facing the parent and holding the parent’s hands, and the provider tipping the child into his or her lap. The teeth are dried first with a 2-inch gauze square. The fluoride is painted on with a brush provided with the varnish. Dr. Clark uses a head lamp as a light source so she has full use of both hands. Some providers use a dental mirror to increase visibility, but “I don’t find this necessary for most young children,” she said.
Questions about the safety of fluoride overall and fluoride varnish specifically “will come up” during discussions of oral health, Dr. Clark said. The only scientifically proven risk of fluoride is the development of fluorosis, which may occur if too much fluoride is ingested during the period of tooth and bone development, she said.
The small rise in plasma fluoride levels that can follow an application of fluoride varnish is comparable to ingesting a 1 mg fluoride tablet or brushing with fluoridated toothpaste, Dr. Clark said. Parents should be instructed not to brush the child’s teeth that evening or give any fluoride supplementation that day, if supplements are being used.
Not brushing teeth until the next morning also allows the varnish to stay on and continue depositing fluoride, she said. The child may eat, drink, and use a pacifier immediately after a varnish application. Hot, sticky, and crunchy foods should be avoided the same day.
The only contraindications to fluoride varnish are allergy to colophony/pine rosin, allergy to pine nuts, and ulcerative gingivitis/stomatitis or other open lesions. There are only three cases in the literature of side effects: one case of contact dermatitis and two cases of stomatitis. Colophony-free versions of fluoride varnish are available, Dr. Clark said.
Fluoride varnish is approved by the Food and Drug Administration as a cavity liner – not as a cavity prevention agent – but more than 110 studies and 40 clinical trials have documented its safety and effectiveness for cavity prevention, Dr. Clark reported. The 0.25 ml dose of varnish, which costs between $1 and $2, is the appropriate dose for children aged 4 years and under.Fluoride varnish is part of a bigger picture of oral health care in pediatrics – one that, first and foremost, involves “routinely asking if your patients have a dental home,” Dr. Clark said. The effectiveness of fluoride varnish is enhanced by regular discussions of oral health and counseling about risk factors for early childhood caries, such as frequent snacking and continual bottle or sippy cup use with fluid other than water.
Both Dr. Clark and Dr. Quiñonez urged pediatricians to take advantage of the parallels between obesity prevention and early childhood caries prevention nutritional messages (such as the risks of frequent juice and soda). And Dr. Clark suggested talking about bacteria and not just hygiene. “It sounds better to blame the evil bacteria than it does to blame poor hygiene, and that’s fine,” she said. “We can talk about how we’re going to keep the bacteria at bay.”
Dr. Quiñonez pointed out that children who were born premature or with low birth weights tend to have a higher prevalence of enamel defects and therefore are at greater risk of developing early childhood caries.
The AAP successfully advocated that fluoride varnish application be reimbursed as a separately reported service with use of the medical CPT code 99188. Use of the code to report fluoride varnish application by a physician or other qualified health professional took effect in January 2015. In some states, the dental code D1206 has been used with a V modifier specific to prophylactic fluoride administration for reimbursement through Medicaid and managed care. The modifier for use in ICD-10 is Z41.8.
“I’m in New York state, and we’ve been reimbursed $30 per fluoride varnish application (since 2009), and this includes risk assessment and counseling,” said Dr. Clark. “Some states pay in the single digits, and some pay in the high $50s.”
State by state information on payment and a host of practice tools and information on fluoride, fluoride varnish, and oral health risk assessment and counseling are available at the AAP’s Oral Health website. The site also provides links to each state’s AAP Chapter Oral Health Advocate who provides or coordinates education and training.
WASHINGTON – With fluoride varnish treatments now on the Bright Futures periodicity schedule, reimbursement is attainable, and pediatricians can focus on integrating the 45- to 60-second procedure into their practices and strengthening their oral health messaging to families.
Pediatrician Melinda Clark and pediatric dentist Rocio B. Quiñonez teamed up at the annual meeting of the American Academy of Pediatrics to deliver this message and to show pediatricians through a hands-on workshop how simple and important fluoride varnishing and oral health counseling are to pediatric preventive care.
“We have to own a part of this,” said Dr. Clark of the Albany (N.Y.) Medical Center Pediatric Group. With the dental community overloaded and dental caries the most common chronic childhood disease, “we cannot just cut out the teeth from our medical prevention paradigm.”
Dental caries is five times more common than asthma and seven times more common than hay fever. One in four children begin kindergarten with a history of early childhood caries, and children with the disease are three times as likely to miss school. The disease can progress to local infections, systemic infection, and in rare cases, death.
In 2014, the U.S. Preventive Services Task Force (USPSTF) recommended that primary care clinicians apply fluoride varnish to the primary teeth of all infants and children starting at the age of primary tooth eruption. The USPSTF did not specifically recommend the frequency of application, but in a clinical report published later in 2014 on “Fluoride Use in Caries Prevention in the Primary Care Setting,” the American Academy of Pediatrics recommended fluoride varnish at least once every 6 months – and preferably every 3 months – starting at tooth emergence (Pediatrics. 2014 Sep;134[3]:626-33).
And in September 2015, fluoride varnish was added to the Bright Futures Guidelines for Health Supervision of Infants, Children, and Adolescents and integrated into the Bright Futures–AAP periodicity schedule.
Both the B recommendation given by the USPSTF to fluoride varnish application and inclusion in the Bright Futures periodicity schedule mean that it is required by the Affordable Care Act to be covered by insurers without out of pocket costs to the patient. Currently, 49 states are reimbursing physicians for fluoride varnish in the Medicaid population.
“It’s become the standard of care,” said Dr. Quiñonez of the division of pediatric dentistry at the University of North Carolina at Chapel Hill.
Fluoride varnish is a concentrated topical fluoride that sets on contact with saliva and helps prevent caries by enhancing remineralization and inhibiting bacterial enzymes. It has been shown to reduce decay by 30%-63%, depending on whether it is coupled with dental health counseling. The treatment has its greatest effect when applied before the onset of caries, but it also may help halt or reverse early carious lesions, which present as decalcified “white spot lesions” along the gum line.
“We have months, often times many months, to prevent disease and to intervene in the earliest stages [of childhood caries] … before children end up in the hospital or operating room,” said Dr. Clark, a former member of the AAP’s Section on Oral Health Executive Committee and a lead author of the AAP’s report on fluoride use.
She advised taking a systematic approach to applying the varnish. “I often apply it by arches [upper and lower, one dab per arch], as opposed to quadrants,” she said. “As long as you’re painting all the surfaces of every tooth with a thin layer of fluoride varnish, it’s an incredibly safe and effective procedure.”
“And you’ll get good at keeping the tongue out of the way using the gauze,” she said.
Varnish is best applied in infants and toddlers in a knee-to-knee format [provider-to-parent] with the child facing the parent and holding the parent’s hands, and the provider tipping the child into his or her lap. The teeth are dried first with a 2-inch gauze square. The fluoride is painted on with a brush provided with the varnish. Dr. Clark uses a head lamp as a light source so she has full use of both hands. Some providers use a dental mirror to increase visibility, but “I don’t find this necessary for most young children,” she said.
Questions about the safety of fluoride overall and fluoride varnish specifically “will come up” during discussions of oral health, Dr. Clark said. The only scientifically proven risk of fluoride is the development of fluorosis, which may occur if too much fluoride is ingested during the period of tooth and bone development, she said.
The small rise in plasma fluoride levels that can follow an application of fluoride varnish is comparable to ingesting a 1 mg fluoride tablet or brushing with fluoridated toothpaste, Dr. Clark said. Parents should be instructed not to brush the child’s teeth that evening or give any fluoride supplementation that day, if supplements are being used.
Not brushing teeth until the next morning also allows the varnish to stay on and continue depositing fluoride, she said. The child may eat, drink, and use a pacifier immediately after a varnish application. Hot, sticky, and crunchy foods should be avoided the same day.
The only contraindications to fluoride varnish are allergy to colophony/pine rosin, allergy to pine nuts, and ulcerative gingivitis/stomatitis or other open lesions. There are only three cases in the literature of side effects: one case of contact dermatitis and two cases of stomatitis. Colophony-free versions of fluoride varnish are available, Dr. Clark said.
Fluoride varnish is approved by the Food and Drug Administration as a cavity liner – not as a cavity prevention agent – but more than 110 studies and 40 clinical trials have documented its safety and effectiveness for cavity prevention, Dr. Clark reported. The 0.25 ml dose of varnish, which costs between $1 and $2, is the appropriate dose for children aged 4 years and under.Fluoride varnish is part of a bigger picture of oral health care in pediatrics – one that, first and foremost, involves “routinely asking if your patients have a dental home,” Dr. Clark said. The effectiveness of fluoride varnish is enhanced by regular discussions of oral health and counseling about risk factors for early childhood caries, such as frequent snacking and continual bottle or sippy cup use with fluid other than water.
Both Dr. Clark and Dr. Quiñonez urged pediatricians to take advantage of the parallels between obesity prevention and early childhood caries prevention nutritional messages (such as the risks of frequent juice and soda). And Dr. Clark suggested talking about bacteria and not just hygiene. “It sounds better to blame the evil bacteria than it does to blame poor hygiene, and that’s fine,” she said. “We can talk about how we’re going to keep the bacteria at bay.”
Dr. Quiñonez pointed out that children who were born premature or with low birth weights tend to have a higher prevalence of enamel defects and therefore are at greater risk of developing early childhood caries.
The AAP successfully advocated that fluoride varnish application be reimbursed as a separately reported service with use of the medical CPT code 99188. Use of the code to report fluoride varnish application by a physician or other qualified health professional took effect in January 2015. In some states, the dental code D1206 has been used with a V modifier specific to prophylactic fluoride administration for reimbursement through Medicaid and managed care. The modifier for use in ICD-10 is Z41.8.
“I’m in New York state, and we’ve been reimbursed $30 per fluoride varnish application (since 2009), and this includes risk assessment and counseling,” said Dr. Clark. “Some states pay in the single digits, and some pay in the high $50s.”
State by state information on payment and a host of practice tools and information on fluoride, fluoride varnish, and oral health risk assessment and counseling are available at the AAP’s Oral Health website. The site also provides links to each state’s AAP Chapter Oral Health Advocate who provides or coordinates education and training.
EXPERT ANALYSIS FROM THE AAP NATIONAL CONFERENCE
AAP: Use ‘multiple layers’ to combat intimate partner violence
WASHINGTON – Pediatric practices can combat the toxic stress created by intimate partner violence – and often prevent child maltreatment – by providing “multiple layers of opportunity” for disclosure and access to resources, Dr. Kimberly Randell said at the annual meeting of the American Academy of Pediatrics.
Each year, approximately 15.5 million children – disproportionately younger children – are exposed to intimate partner violence (IPV) (J Fam Psychol. 2006;20[1]:137-42). Their mothers, IPV victims, will seek care for their children when they don’t seek care for themselves, and they will address IPV for their children, she said.
“These are women who are coming in for the 2-, 4-, 6-month visits, but haven’t seen their ob for the postpartum visit ,and they may not see their primary care physician for several more years,” said Dr. Randell, who coordinates the IPV program at Children’s Mercy Hospital in Kansas City, Mo. “They’ll address IPV in the context of how it affects their kids.”
Between 1 in 3 women and 1 in 4 men will experience intimate partner violence (IPV) at some point in their lifetime, according to The National Intimate Partner and Sexual Violence Survey 2010 Summary Report by the Centers for Disease Control and Prevention. Families experiencing IPV “look no different from families who aren’t,” making it worthwhile to universally screen for the problem as part of anticipatory guidance. There is no hard evidence favoring written or verbal assessment – “it all depends on what works best for your practice,” Dr. Randell said.
However, she implored pediatricians to line up advocacy resources, educate staff, and develop processes for intervention. “We know that if you just hand someone a pamphlet or a help line number and say ‘call when you’re ready,’ the odds are they’re not going to call,” Dr. Randell said.
Instead, tell the mother you would like to connect her with a community partner who specializes in IVP and can help her figure out a plan for her and her child’s safety. Ideally, a nurse or staff member in the pediatric office who is educated about IVP could be the initial link – someone “to whom you can make a warm hand-off.”
In this case, she explained, the pediatrician can “say something like, ‘I’d like you to talk with Jennifer. She knows a lot about situations like these and can offer some resources. We can even make the call from the office today.’ ”
Phone calls made from the office, when agreed to, are “very safe calls,” Dr. Randell emphasized.
Ideally, pediatric offices can partner with a local IPV agency for education and referrals. Other possibilities are the social work department at a local children’s hospital or the National Domestic Violence hot line (1-800-799-7233, 1-800-787-3224 TTY). Dr. Randell advised using the term “help line” instead of “hotline” because, in her experience, families associate a “hotline” with children “being taken away.”
Physicians worry about damaging trust by asking about IPV, but numerous studies show most mothers agree that pediatric health care providers should ask.
Introducing questions about IPV with a “framing statement” can minimize any perception of judgment. An example: “Because violence at home is common and affects children’s health and safety, I now ask all families in my practice about exposure to violence.”
The framing statement can then be followed with an indirect question such as “Do you feel safe at home and in your relationship?” or a more direct question, such as:
• “Has your child ever seen a violent or frightening event at home or in your neighborhood?”
• “Have you ever been hurt or threatened by your partner?”
• “Do you ever feel afraid of or controlled by or isolated by your partner?”
IPV is an adverse childhood experience that not only creates toxic stress, but puts children at significantly higher risk – up to 15 times the risk – for all forms of childhood maltreatment. Men also experience IPV, but women are most frequently the nonoffenders, she noted.
Pediatricians should know their states’ child abuse and IVP reporting laws, and inform the nonoffending parent of any limits on confidentiality. “If your state has mandatory reporting for exposure to IVP, you need to let the parent know,” she said. “They need to be able to take this into consideration when they’re deciding if it’s safe or the right time to disclose.”
Dr. Randell advised physicians to try to involve the parent when reporting IPV, either per mandatory reporting laws or per results of a child safety assessment. Explain that you’d like them to make the report with you,” she said. “This can be an important step in maintaining a trusting relationship and empowering her.”
Care must be taken in documenting IPV disclosure because the abusive parent often has access to the child’s chart and/or receives insurance statements. Dr. Randell offered several tips:
Use limited, coded documentation in the chart.
• Do not use IPV-related billing codes or mention the terms “domestic violence” or “IPV.”
• Do not use the word shelter or include notes about safety plans.
• Do not screen in the presence of verbal children, or children aged 3 years and older.
Children may inadvertently tell the abuser that mom has been talking to someone, she explained. “And it’s also probably bad for kids to hear mom denying [IPV] because it reinforces that this is a behavior that we keep secret and don’t talk about.”
Posters, pamphlets, and other environmental cues are an important layer for helping families who are experiencing IPV, largely because these items provide women with the opportunity to access resources without having to disclose IPV.
In focus groups at Children’s Mercy, mothers who had experienced or were experiencing IPV said they wanted information “not only on what IPV looks like … but about how it impacts kids, about resources, and about safety planning,” Dr. Randell said. “And they wanted things that are hopeful ... They don’t want to be labeled [as victims].”
There are several validated screening instruments for IPV (such as the Partner Violence Screen and the Woman Abuse Screening Tool), but the tools have significantly variable sensitivities and specificities and have not been studied in pediatric settings. General psychosocial screening tools used in pediatrics, such as the Pediatric Symptom Checklist and the Strengths and Difficulties Questionnaire, may provide clues of possible trauma, including IPV, she noted.
Among the resources recommended by Dr. Randell:
• The Harvard Center for the Developing Child (www.developingchild.harvard.edu).
• Futures Without Violence (www.futureswithoutviolence.org).
• AAP’s policy statement on IPV: pediatrics.aappublications.org/content/125/5/1094).
WASHINGTON – Pediatric practices can combat the toxic stress created by intimate partner violence – and often prevent child maltreatment – by providing “multiple layers of opportunity” for disclosure and access to resources, Dr. Kimberly Randell said at the annual meeting of the American Academy of Pediatrics.
Each year, approximately 15.5 million children – disproportionately younger children – are exposed to intimate partner violence (IPV) (J Fam Psychol. 2006;20[1]:137-42). Their mothers, IPV victims, will seek care for their children when they don’t seek care for themselves, and they will address IPV for their children, she said.
“These are women who are coming in for the 2-, 4-, 6-month visits, but haven’t seen their ob for the postpartum visit ,and they may not see their primary care physician for several more years,” said Dr. Randell, who coordinates the IPV program at Children’s Mercy Hospital in Kansas City, Mo. “They’ll address IPV in the context of how it affects their kids.”
Between 1 in 3 women and 1 in 4 men will experience intimate partner violence (IPV) at some point in their lifetime, according to The National Intimate Partner and Sexual Violence Survey 2010 Summary Report by the Centers for Disease Control and Prevention. Families experiencing IPV “look no different from families who aren’t,” making it worthwhile to universally screen for the problem as part of anticipatory guidance. There is no hard evidence favoring written or verbal assessment – “it all depends on what works best for your practice,” Dr. Randell said.
However, she implored pediatricians to line up advocacy resources, educate staff, and develop processes for intervention. “We know that if you just hand someone a pamphlet or a help line number and say ‘call when you’re ready,’ the odds are they’re not going to call,” Dr. Randell said.
Instead, tell the mother you would like to connect her with a community partner who specializes in IVP and can help her figure out a plan for her and her child’s safety. Ideally, a nurse or staff member in the pediatric office who is educated about IVP could be the initial link – someone “to whom you can make a warm hand-off.”
In this case, she explained, the pediatrician can “say something like, ‘I’d like you to talk with Jennifer. She knows a lot about situations like these and can offer some resources. We can even make the call from the office today.’ ”
Phone calls made from the office, when agreed to, are “very safe calls,” Dr. Randell emphasized.
Ideally, pediatric offices can partner with a local IPV agency for education and referrals. Other possibilities are the social work department at a local children’s hospital or the National Domestic Violence hot line (1-800-799-7233, 1-800-787-3224 TTY). Dr. Randell advised using the term “help line” instead of “hotline” because, in her experience, families associate a “hotline” with children “being taken away.”
Physicians worry about damaging trust by asking about IPV, but numerous studies show most mothers agree that pediatric health care providers should ask.
Introducing questions about IPV with a “framing statement” can minimize any perception of judgment. An example: “Because violence at home is common and affects children’s health and safety, I now ask all families in my practice about exposure to violence.”
The framing statement can then be followed with an indirect question such as “Do you feel safe at home and in your relationship?” or a more direct question, such as:
• “Has your child ever seen a violent or frightening event at home or in your neighborhood?”
• “Have you ever been hurt or threatened by your partner?”
• “Do you ever feel afraid of or controlled by or isolated by your partner?”
IPV is an adverse childhood experience that not only creates toxic stress, but puts children at significantly higher risk – up to 15 times the risk – for all forms of childhood maltreatment. Men also experience IPV, but women are most frequently the nonoffenders, she noted.
Pediatricians should know their states’ child abuse and IVP reporting laws, and inform the nonoffending parent of any limits on confidentiality. “If your state has mandatory reporting for exposure to IVP, you need to let the parent know,” she said. “They need to be able to take this into consideration when they’re deciding if it’s safe or the right time to disclose.”
Dr. Randell advised physicians to try to involve the parent when reporting IPV, either per mandatory reporting laws or per results of a child safety assessment. Explain that you’d like them to make the report with you,” she said. “This can be an important step in maintaining a trusting relationship and empowering her.”
Care must be taken in documenting IPV disclosure because the abusive parent often has access to the child’s chart and/or receives insurance statements. Dr. Randell offered several tips:
Use limited, coded documentation in the chart.
• Do not use IPV-related billing codes or mention the terms “domestic violence” or “IPV.”
• Do not use the word shelter or include notes about safety plans.
• Do not screen in the presence of verbal children, or children aged 3 years and older.
Children may inadvertently tell the abuser that mom has been talking to someone, she explained. “And it’s also probably bad for kids to hear mom denying [IPV] because it reinforces that this is a behavior that we keep secret and don’t talk about.”
Posters, pamphlets, and other environmental cues are an important layer for helping families who are experiencing IPV, largely because these items provide women with the opportunity to access resources without having to disclose IPV.
In focus groups at Children’s Mercy, mothers who had experienced or were experiencing IPV said they wanted information “not only on what IPV looks like … but about how it impacts kids, about resources, and about safety planning,” Dr. Randell said. “And they wanted things that are hopeful ... They don’t want to be labeled [as victims].”
There are several validated screening instruments for IPV (such as the Partner Violence Screen and the Woman Abuse Screening Tool), but the tools have significantly variable sensitivities and specificities and have not been studied in pediatric settings. General psychosocial screening tools used in pediatrics, such as the Pediatric Symptom Checklist and the Strengths and Difficulties Questionnaire, may provide clues of possible trauma, including IPV, she noted.
Among the resources recommended by Dr. Randell:
• The Harvard Center for the Developing Child (www.developingchild.harvard.edu).
• Futures Without Violence (www.futureswithoutviolence.org).
• AAP’s policy statement on IPV: pediatrics.aappublications.org/content/125/5/1094).
WASHINGTON – Pediatric practices can combat the toxic stress created by intimate partner violence – and often prevent child maltreatment – by providing “multiple layers of opportunity” for disclosure and access to resources, Dr. Kimberly Randell said at the annual meeting of the American Academy of Pediatrics.
Each year, approximately 15.5 million children – disproportionately younger children – are exposed to intimate partner violence (IPV) (J Fam Psychol. 2006;20[1]:137-42). Their mothers, IPV victims, will seek care for their children when they don’t seek care for themselves, and they will address IPV for their children, she said.
“These are women who are coming in for the 2-, 4-, 6-month visits, but haven’t seen their ob for the postpartum visit ,and they may not see their primary care physician for several more years,” said Dr. Randell, who coordinates the IPV program at Children’s Mercy Hospital in Kansas City, Mo. “They’ll address IPV in the context of how it affects their kids.”
Between 1 in 3 women and 1 in 4 men will experience intimate partner violence (IPV) at some point in their lifetime, according to The National Intimate Partner and Sexual Violence Survey 2010 Summary Report by the Centers for Disease Control and Prevention. Families experiencing IPV “look no different from families who aren’t,” making it worthwhile to universally screen for the problem as part of anticipatory guidance. There is no hard evidence favoring written or verbal assessment – “it all depends on what works best for your practice,” Dr. Randell said.
However, she implored pediatricians to line up advocacy resources, educate staff, and develop processes for intervention. “We know that if you just hand someone a pamphlet or a help line number and say ‘call when you’re ready,’ the odds are they’re not going to call,” Dr. Randell said.
Instead, tell the mother you would like to connect her with a community partner who specializes in IVP and can help her figure out a plan for her and her child’s safety. Ideally, a nurse or staff member in the pediatric office who is educated about IVP could be the initial link – someone “to whom you can make a warm hand-off.”
In this case, she explained, the pediatrician can “say something like, ‘I’d like you to talk with Jennifer. She knows a lot about situations like these and can offer some resources. We can even make the call from the office today.’ ”
Phone calls made from the office, when agreed to, are “very safe calls,” Dr. Randell emphasized.
Ideally, pediatric offices can partner with a local IPV agency for education and referrals. Other possibilities are the social work department at a local children’s hospital or the National Domestic Violence hot line (1-800-799-7233, 1-800-787-3224 TTY). Dr. Randell advised using the term “help line” instead of “hotline” because, in her experience, families associate a “hotline” with children “being taken away.”
Physicians worry about damaging trust by asking about IPV, but numerous studies show most mothers agree that pediatric health care providers should ask.
Introducing questions about IPV with a “framing statement” can minimize any perception of judgment. An example: “Because violence at home is common and affects children’s health and safety, I now ask all families in my practice about exposure to violence.”
The framing statement can then be followed with an indirect question such as “Do you feel safe at home and in your relationship?” or a more direct question, such as:
• “Has your child ever seen a violent or frightening event at home or in your neighborhood?”
• “Have you ever been hurt or threatened by your partner?”
• “Do you ever feel afraid of or controlled by or isolated by your partner?”
IPV is an adverse childhood experience that not only creates toxic stress, but puts children at significantly higher risk – up to 15 times the risk – for all forms of childhood maltreatment. Men also experience IPV, but women are most frequently the nonoffenders, she noted.
Pediatricians should know their states’ child abuse and IVP reporting laws, and inform the nonoffending parent of any limits on confidentiality. “If your state has mandatory reporting for exposure to IVP, you need to let the parent know,” she said. “They need to be able to take this into consideration when they’re deciding if it’s safe or the right time to disclose.”
Dr. Randell advised physicians to try to involve the parent when reporting IPV, either per mandatory reporting laws or per results of a child safety assessment. Explain that you’d like them to make the report with you,” she said. “This can be an important step in maintaining a trusting relationship and empowering her.”
Care must be taken in documenting IPV disclosure because the abusive parent often has access to the child’s chart and/or receives insurance statements. Dr. Randell offered several tips:
Use limited, coded documentation in the chart.
• Do not use IPV-related billing codes or mention the terms “domestic violence” or “IPV.”
• Do not use the word shelter or include notes about safety plans.
• Do not screen in the presence of verbal children, or children aged 3 years and older.
Children may inadvertently tell the abuser that mom has been talking to someone, she explained. “And it’s also probably bad for kids to hear mom denying [IPV] because it reinforces that this is a behavior that we keep secret and don’t talk about.”
Posters, pamphlets, and other environmental cues are an important layer for helping families who are experiencing IPV, largely because these items provide women with the opportunity to access resources without having to disclose IPV.
In focus groups at Children’s Mercy, mothers who had experienced or were experiencing IPV said they wanted information “not only on what IPV looks like … but about how it impacts kids, about resources, and about safety planning,” Dr. Randell said. “And they wanted things that are hopeful ... They don’t want to be labeled [as victims].”
There are several validated screening instruments for IPV (such as the Partner Violence Screen and the Woman Abuse Screening Tool), but the tools have significantly variable sensitivities and specificities and have not been studied in pediatric settings. General psychosocial screening tools used in pediatrics, such as the Pediatric Symptom Checklist and the Strengths and Difficulties Questionnaire, may provide clues of possible trauma, including IPV, she noted.
Among the resources recommended by Dr. Randell:
• The Harvard Center for the Developing Child (www.developingchild.harvard.edu).
• Futures Without Violence (www.futureswithoutviolence.org).
• AAP’s policy statement on IPV: pediatrics.aappublications.org/content/125/5/1094).
EXPERT ANALYSIS FROM THE AAP NATIONAL CONFERENCE