Myth: Parabens are dangerous

Some atopic dermatitis (AD) patients may be misinformed by reports that parabens have estrogenic and antiandrogenic effects and may be involved in carcinogenesis via endocrine modulation. Although in Europe some parabens have been banned or restricted, in the United States there are no regulations against the use of parabens in cosmetics. Dermatologists must acknowledge that their AD patients may have concerns about cosmetic products and they must be prepared to dispel any myths.

Parabens such as methylparaben, propylparaben, butylparaben, and ethylparaben are common in cosmetics such as moisturizers. Parabens have protective properties to prevent the growth of harmful bacteria and mold. According to the US Food and Drug Administration, “scientists continue to review published studies on the safety of parabens. At this time, we do not have information showing that parabens as they are used in cosmetics have an effect on human health. . . . If we determine that a health hazard exists, we will advise the industry and the public.”

Here are some important facts to note for patients, based on a research article published in Cosmetics & Toiletries in June 2017:

• Parabens are not toxic at the concentrations used in personal care products
• Parabens are not genotoxic or carcinogenic
• Parabens are readily excreted in urine and do not accumulate in tissues

In patients with chronic dermatitis, the Cosmetic Ingredient Review Expert Panel reported that parabens generally induce sensitization in less than 4% of patients. The panel concluded that they can support the safety of cosmetic products in which parabens are used as preservatives.

In fact, one study published in the Journal of the American Academy of Dermatology found that AD patients were not predisposed to allergies to parabens, formaldehyde, or diazolidinyl urea, but they were more likely to have allergic reactions to formaldehyde releasers. As a result, AD patients should choose moisturizers containing parabens and should have no fears about using them.

Expert Commentary

In general I recommend paraben-containing cleansers and emollients on a daily basis in practice. However, patient concerns exist due to negative online content easily accessed and fear can prevent usage of agents. Therefore, I am also open to offering options lacking in parabens, such as coconut oil. 

—Nanette B. Silverberg, MD (New York, New York)

Myth: Parabens are dangerous

Some atopic dermatitis (AD) patients may be misinformed by reports that parabens have estrogenic and antiandrogenic effects and may be involved in carcinogenesis via endocrine modulation. Although in Europe some parabens have been banned or restricted, in the United States there are no regulations against the use of parabens in cosmetics. Dermatologists must acknowledge that their AD patients may have concerns about cosmetic products and they must be prepared to dispel any myths.

Parabens such as methylparaben, propylparaben, butylparaben, and ethylparaben are common in cosmetics such as moisturizers. Parabens have protective properties to prevent the growth of harmful bacteria and mold. According to the US Food and Drug Administration, “scientists continue to review published studies on the safety of parabens. At this time, we do not have information showing that parabens as they are used in cosmetics have an effect on human health. . . . If we determine that a health hazard exists, we will advise the industry and the public.”

Here are some important facts to note for patients, based on a research article published in Cosmetics & Toiletries in June 2017:

• Parabens are not toxic at the concentrations used in personal care products
• Parabens are not genotoxic or carcinogenic
• Parabens are readily excreted in urine and do not accumulate in tissues

In patients with chronic dermatitis, the Cosmetic Ingredient Review Expert Panel reported that parabens generally induce sensitization in less than 4% of patients. The panel concluded that they can support the safety of cosmetic products in which parabens are used as preservatives.

In fact, one study published in the Journal of the American Academy of Dermatology found that AD patients were not predisposed to allergies to parabens, formaldehyde, or diazolidinyl urea, but they were more likely to have allergic reactions to formaldehyde releasers. As a result, AD patients should choose moisturizers containing parabens and should have no fears about using them.

Expert Commentary

In general I recommend paraben-containing cleansers and emollients on a daily basis in practice. However, patient concerns exist due to negative online content easily accessed and fear can prevent usage of agents. Therefore, I am also open to offering options lacking in parabens, such as coconut oil. 

—Nanette B. Silverberg, MD (New York, New York)

Myth: Parabens are dangerous

Some atopic dermatitis (AD) patients may be misinformed by reports that parabens have estrogenic and antiandrogenic effects and may be involved in carcinogenesis via endocrine modulation. Although in Europe some parabens have been banned or restricted, in the United States there are no regulations against the use of parabens in cosmetics. Dermatologists must acknowledge that their AD patients may have concerns about cosmetic products and they must be prepared to dispel any myths.

Parabens such as methylparaben, propylparaben, butylparaben, and ethylparaben are common in cosmetics such as moisturizers. Parabens have protective properties to prevent the growth of harmful bacteria and mold. According to the US Food and Drug Administration, “scientists continue to review published studies on the safety of parabens. At this time, we do not have information showing that parabens as they are used in cosmetics have an effect on human health. . . . If we determine that a health hazard exists, we will advise the industry and the public.”

Here are some important facts to note for patients, based on a research article published in Cosmetics & Toiletries in June 2017:

• Parabens are not toxic at the concentrations used in personal care products
• Parabens are not genotoxic or carcinogenic
• Parabens are readily excreted in urine and do not accumulate in tissues

In patients with chronic dermatitis, the Cosmetic Ingredient Review Expert Panel reported that parabens generally induce sensitization in less than 4% of patients. The panel concluded that they can support the safety of cosmetic products in which parabens are used as preservatives.

In fact, one study published in the Journal of the American Academy of Dermatology found that AD patients were not predisposed to allergies to parabens, formaldehyde, or diazolidinyl urea, but they were more likely to have allergic reactions to formaldehyde releasers. As a result, AD patients should choose moisturizers containing parabens and should have no fears about using them.

Expert Commentary

In general I recommend paraben-containing cleansers and emollients on a daily basis in practice. However, patient concerns exist due to negative online content easily accessed and fear can prevent usage of agents. Therefore, I am also open to offering options lacking in parabens, such as coconut oil. 

—Nanette B. Silverberg, MD (New York, New York)

For women with young-onset breast cancer, presence of a BRCA mutation did not significantly impact survival, according to results of the Prospective Outcomes in Sporadic versus Hereditary breast cancer (POSH) study.

BRCA-positive and BRCA-negative women had similar overall survival at 2 years, 5 years, and 10 years after diagnosis, according to lead author Ellen R. Copson, MD, a senior lecturer in medical oncology in the cancer sciences division, University of Southampton (England) and her study coauthors.

SOURCE: Copson et al. Lancet Oncol. 2018 Jan 11 doi: 10.1016/S1470-2045(17)30891-4.

For women with young-onset breast cancer, presence of a BRCA mutation did not significantly impact survival, according to results of the Prospective Outcomes in Sporadic versus Hereditary breast cancer (POSH) study.

BRCA-positive and BRCA-negative women had similar overall survival at 2 years, 5 years, and 10 years after diagnosis, according to lead author Ellen R. Copson, MD, a senior lecturer in medical oncology in the cancer sciences division, University of Southampton (England) and her study coauthors.

SOURCE: Copson et al. Lancet Oncol. 2018 Jan 11 doi: 10.1016/S1470-2045(17)30891-4.

For women with young-onset breast cancer, presence of a BRCA mutation did not significantly impact survival, according to results of the Prospective Outcomes in Sporadic versus Hereditary breast cancer (POSH) study.

BRCA-positive and BRCA-negative women had similar overall survival at 2 years, 5 years, and 10 years after diagnosis, according to lead author Ellen R. Copson, MD, a senior lecturer in medical oncology in the cancer sciences division, University of Southampton (England) and her study coauthors.

SOURCE: Copson et al. Lancet Oncol. 2018 Jan 11 doi: 10.1016/S1470-2045(17)30891-4.

ORLANDO – A high fraction of U.S. patients with atrial fibrillation receive an inappropriately low dosage of an anticoagulant for stroke prevention, often in a misguided attempt to avoid potential bleeding complications.

When physicians “reduce the dose to prevent a bleed they increase the risk for an ischemic stroke,” Elaine M. Hylek, MD, said in a video interview during the annual International AF Symposium.

Recent data on actual anticoagulant dosages prescribed to U.S. patients with atrial fibrillation show that “an unexpectedly high proportion of prescriptions for apixaban (Eliquis), dabigatran (Pradaxa), and rivaroxaban (Xarelto) are given at lower doses,” Dr. Hylek noted at the meeting. The lower-dose formulations with U.S. marketing are only appropriate for patients on apixaban with at least two of the following: serum creatinine 1.5 mg/dL or higher, age 80 years or older, and weight 60 kg or less; patients on dabigatran with moderate renal impairment or treated with dronedarone or systemic ketoconazole; or patients on rivaroxaban with a creatinine clearance of 15-50 mL/min.

For example, in the pivotal trial for apixaban only 5% of atrial fibrillation patients qualified for the lower dosage, yet recent data have shown that, in actual U.S. practice roughly a quarter of patients were on this lower dosage, said Dr. Hylek, professor of medicine at Boston University and director of the thrombosis and anticoagulation service at Boston Medical Center (Curr Med Res Opin. 2016 July;32[7]:1277-79). A second recent report showed that among U.S. patients with atrial fibrillation hospitalized for an ischemic stroke 84% had received inadequate anticoagulation with either subtherapeutic dosages of anticoagulant or no anticoagulant at all (JAMA. 2017 Mar 14;317[10]:1057-67).

Another manifestation of the underprescribing problem are patients with atrial fibrillation treated with aspirin only, an approach proven ineffective for preventing ischemic strokes in these patients, Dr. Hylek said.

Dr. Hylek has been an advisor to or has received honoraria from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Doasense, Janssen, Medtronic, Pfizer, and Portola, and she has received research funding from Boehringer Ingelheim, Bristol-Myers Squibb, and Janssen.

[email protected]

On Twitter @mitchelzoler
 

ORLANDO – A high fraction of U.S. patients with atrial fibrillation receive an inappropriately low dosage of an anticoagulant for stroke prevention, often in a misguided attempt to avoid potential bleeding complications.

When physicians “reduce the dose to prevent a bleed they increase the risk for an ischemic stroke,” Elaine M. Hylek, MD, said in a video interview during the annual International AF Symposium.

Recent data on actual anticoagulant dosages prescribed to U.S. patients with atrial fibrillation show that “an unexpectedly high proportion of prescriptions for apixaban (Eliquis), dabigatran (Pradaxa), and rivaroxaban (Xarelto) are given at lower doses,” Dr. Hylek noted at the meeting. The lower-dose formulations with U.S. marketing are only appropriate for patients on apixaban with at least two of the following: serum creatinine 1.5 mg/dL or higher, age 80 years or older, and weight 60 kg or less; patients on dabigatran with moderate renal impairment or treated with dronedarone or systemic ketoconazole; or patients on rivaroxaban with a creatinine clearance of 15-50 mL/min.

For example, in the pivotal trial for apixaban only 5% of atrial fibrillation patients qualified for the lower dosage, yet recent data have shown that, in actual U.S. practice roughly a quarter of patients were on this lower dosage, said Dr. Hylek, professor of medicine at Boston University and director of the thrombosis and anticoagulation service at Boston Medical Center (Curr Med Res Opin. 2016 July;32[7]:1277-79). A second recent report showed that among U.S. patients with atrial fibrillation hospitalized for an ischemic stroke 84% had received inadequate anticoagulation with either subtherapeutic dosages of anticoagulant or no anticoagulant at all (JAMA. 2017 Mar 14;317[10]:1057-67).

Another manifestation of the underprescribing problem are patients with atrial fibrillation treated with aspirin only, an approach proven ineffective for preventing ischemic strokes in these patients, Dr. Hylek said.

Dr. Hylek has been an advisor to or has received honoraria from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Doasense, Janssen, Medtronic, Pfizer, and Portola, and she has received research funding from Boehringer Ingelheim, Bristol-Myers Squibb, and Janssen.

[email protected]

On Twitter @mitchelzoler
 

ORLANDO – A high fraction of U.S. patients with atrial fibrillation receive an inappropriately low dosage of an anticoagulant for stroke prevention, often in a misguided attempt to avoid potential bleeding complications.

When physicians “reduce the dose to prevent a bleed they increase the risk for an ischemic stroke,” Elaine M. Hylek, MD, said in a video interview during the annual International AF Symposium.

Recent data on actual anticoagulant dosages prescribed to U.S. patients with atrial fibrillation show that “an unexpectedly high proportion of prescriptions for apixaban (Eliquis), dabigatran (Pradaxa), and rivaroxaban (Xarelto) are given at lower doses,” Dr. Hylek noted at the meeting. The lower-dose formulations with U.S. marketing are only appropriate for patients on apixaban with at least two of the following: serum creatinine 1.5 mg/dL or higher, age 80 years or older, and weight 60 kg or less; patients on dabigatran with moderate renal impairment or treated with dronedarone or systemic ketoconazole; or patients on rivaroxaban with a creatinine clearance of 15-50 mL/min.

For example, in the pivotal trial for apixaban only 5% of atrial fibrillation patients qualified for the lower dosage, yet recent data have shown that, in actual U.S. practice roughly a quarter of patients were on this lower dosage, said Dr. Hylek, professor of medicine at Boston University and director of the thrombosis and anticoagulation service at Boston Medical Center (Curr Med Res Opin. 2016 July;32[7]:1277-79). A second recent report showed that among U.S. patients with atrial fibrillation hospitalized for an ischemic stroke 84% had received inadequate anticoagulation with either subtherapeutic dosages of anticoagulant or no anticoagulant at all (JAMA. 2017 Mar 14;317[10]:1057-67).

Another manifestation of the underprescribing problem are patients with atrial fibrillation treated with aspirin only, an approach proven ineffective for preventing ischemic strokes in these patients, Dr. Hylek said.

Dr. Hylek has been an advisor to or has received honoraria from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Doasense, Janssen, Medtronic, Pfizer, and Portola, and she has received research funding from Boehringer Ingelheim, Bristol-Myers Squibb, and Janssen.

[email protected]

On Twitter @mitchelzoler
 

PARIS – Older patients with a psychotic depression and complete remission within the first four electroconvulsive therapy sessions are the ones with the best chance of remaining relapse free for at least 6 months, Pascal Sienaert, MD, PhD, reported at the annual congress of the European College of Neuropsychopharmacology.

This conclusion is based on the results of two prospective studies by ResPECT – the Research in Psychiatry and ECT by the Flemish-Dutch Research Consortium – which, in turn, confirm the findings of an earlier metaanalysis of 32 studies including 702 patients conducted by investigators at Trinity College Dublin, noted Dr. Sienaert, a psychiatrist at the Catholic University of Leuven (Belgium) Academic Center for ECT and Neuromodulation.

Bruce Jancin/Frontline Medical News

PARIS – Older patients with a psychotic depression and complete remission within the first four electroconvulsive therapy sessions are the ones with the best chance of remaining relapse free for at least 6 months, Pascal Sienaert, MD, PhD, reported at the annual congress of the European College of Neuropsychopharmacology.

This conclusion is based on the results of two prospective studies by ResPECT – the Research in Psychiatry and ECT by the Flemish-Dutch Research Consortium – which, in turn, confirm the findings of an earlier metaanalysis of 32 studies including 702 patients conducted by investigators at Trinity College Dublin, noted Dr. Sienaert, a psychiatrist at the Catholic University of Leuven (Belgium) Academic Center for ECT and Neuromodulation.

Bruce Jancin/Frontline Medical News

PARIS – Older patients with a psychotic depression and complete remission within the first four electroconvulsive therapy sessions are the ones with the best chance of remaining relapse free for at least 6 months, Pascal Sienaert, MD, PhD, reported at the annual congress of the European College of Neuropsychopharmacology.

This conclusion is based on the results of two prospective studies by ResPECT – the Research in Psychiatry and ECT by the Flemish-Dutch Research Consortium – which, in turn, confirm the findings of an earlier metaanalysis of 32 studies including 702 patients conducted by investigators at Trinity College Dublin, noted Dr. Sienaert, a psychiatrist at the Catholic University of Leuven (Belgium) Academic Center for ECT and Neuromodulation.

Bruce Jancin/Frontline Medical News

Altered glutamate signaling tied to variants of a protein called Thorase has been associated with schizophrenia, and the antiseizure medication perampanel might help regulate such deficits, a study showed.

“Perampanel treatment … could offer a potential therapeutic opportunity for treating disorders associated with abnormal AMPAR-mediated neurotransmission,” wrote George K.E. Umanah, PhD, of Johns Hopkins University, Baltimore, and his associates. AMPARs, or alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptors, mediate rapid synaptic transmission in the brain.

The conclusions are based on bidirectional sequence data from a group of adults with schizophrenia and controls, and a murine study.

In the human portion of the study, the researchers analyzed bidirectional sequence data for ATAD1, a protein that codes for Thorase in an Ashkenazi Jewish population. In 712 schizophrenia patients and 649 healthy patients, Dr. Umanah and his associates found three rare gene variants in five individuals. The variants, R9H and D221H, were present only in the patients with schizophrenia. Another variant, E290K, was present in schizophrenia patients as well as in unscreened individuals. The researchers said that the variants found in this analysis might be implicated in schizophrenia.

Building on the observations from the human portion of the study, Dr. Umanah and his colleagues conducted a battery of tests to see whether the observed Thorase variants had any psychological effects on mice that were heterozygous for these variants. The researchers found that these heterozygous Thorase mice were sensitive to psychostimulants, and exhibited impaired memory and social behaviors. Heterozygous Thorase mice also displayed long-term memory and associative learning deficits. Those deficits improved, however, after perampanel was administered.

This study was supported in part by grants from the National Institutes of Health and the Simons Foundation Autism Research Initiative. The authors declared that they have no conflicts of interest.

Read the full study in Science Translational Medicine (2017 Dec 13;9[420]. doi: 10.1126/scitranslmed.aah4985).

[email protected]

Altered glutamate signaling tied to variants of a protein called Thorase has been associated with schizophrenia, and the antiseizure medication perampanel might help regulate such deficits, a study showed.

“Perampanel treatment … could offer a potential therapeutic opportunity for treating disorders associated with abnormal AMPAR-mediated neurotransmission,” wrote George K.E. Umanah, PhD, of Johns Hopkins University, Baltimore, and his associates. AMPARs, or alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptors, mediate rapid synaptic transmission in the brain.

The conclusions are based on bidirectional sequence data from a group of adults with schizophrenia and controls, and a murine study.

In the human portion of the study, the researchers analyzed bidirectional sequence data for ATAD1, a protein that codes for Thorase in an Ashkenazi Jewish population. In 712 schizophrenia patients and 649 healthy patients, Dr. Umanah and his associates found three rare gene variants in five individuals. The variants, R9H and D221H, were present only in the patients with schizophrenia. Another variant, E290K, was present in schizophrenia patients as well as in unscreened individuals. The researchers said that the variants found in this analysis might be implicated in schizophrenia.

Building on the observations from the human portion of the study, Dr. Umanah and his colleagues conducted a battery of tests to see whether the observed Thorase variants had any psychological effects on mice that were heterozygous for these variants. The researchers found that these heterozygous Thorase mice were sensitive to psychostimulants, and exhibited impaired memory and social behaviors. Heterozygous Thorase mice also displayed long-term memory and associative learning deficits. Those deficits improved, however, after perampanel was administered.

This study was supported in part by grants from the National Institutes of Health and the Simons Foundation Autism Research Initiative. The authors declared that they have no conflicts of interest.

Read the full study in Science Translational Medicine (2017 Dec 13;9[420]. doi: 10.1126/scitranslmed.aah4985).

[email protected]

Altered glutamate signaling tied to variants of a protein called Thorase has been associated with schizophrenia, and the antiseizure medication perampanel might help regulate such deficits, a study showed.

“Perampanel treatment … could offer a potential therapeutic opportunity for treating disorders associated with abnormal AMPAR-mediated neurotransmission,” wrote George K.E. Umanah, PhD, of Johns Hopkins University, Baltimore, and his associates. AMPARs, or alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptors, mediate rapid synaptic transmission in the brain.

The conclusions are based on bidirectional sequence data from a group of adults with schizophrenia and controls, and a murine study.

In the human portion of the study, the researchers analyzed bidirectional sequence data for ATAD1, a protein that codes for Thorase in an Ashkenazi Jewish population. In 712 schizophrenia patients and 649 healthy patients, Dr. Umanah and his associates found three rare gene variants in five individuals. The variants, R9H and D221H, were present only in the patients with schizophrenia. Another variant, E290K, was present in schizophrenia patients as well as in unscreened individuals. The researchers said that the variants found in this analysis might be implicated in schizophrenia.

Building on the observations from the human portion of the study, Dr. Umanah and his colleagues conducted a battery of tests to see whether the observed Thorase variants had any psychological effects on mice that were heterozygous for these variants. The researchers found that these heterozygous Thorase mice were sensitive to psychostimulants, and exhibited impaired memory and social behaviors. Heterozygous Thorase mice also displayed long-term memory and associative learning deficits. Those deficits improved, however, after perampanel was administered.

This study was supported in part by grants from the National Institutes of Health and the Simons Foundation Autism Research Initiative. The authors declared that they have no conflicts of interest.

Read the full study in Science Translational Medicine (2017 Dec 13;9[420]. doi: 10.1126/scitranslmed.aah4985).

[email protected]

Communication failures are a leading cause of sentinel events, the most serious adverse events that occur in hospitals.¹ Interventions to improve patient safety have focused on communication between healthcare providers.^2-4 Interventions focusing on communication between providers and families or other patient caregivers are under-studied.^5,6 Given their availability, proximity, historical knowledge, and motivation for a good outcome,⁷ families can play a vital role as “vigilant partners”⁸ in promoting hospital communication and safety.

In this month’s Journal of Hospital Medicine, Solan et al. conducted focus groups and interviews of 61 caregivers of hospitalized pediatric patients at 30 days after discharge to assess their perceptions of communication during hospitalization and discharge home.⁹ They identified several caregiver themes pertaining to communication between the inpatient medical team and families, communication challenges due to the teaching hospital environment, and communication between providers. Caregiver concerns included feeling out of the loop, excessive provider use of medical jargon, confusing messages on rounds, and inadequate communication between inpatient and outpatient providers.

The manuscript serves both to uncover family concerns that may be underappreciated by clinicians and suggest some potential solutions. For instance, caregivers can be apprehensive about whom to call for postdischarge advice because they are sometimes uncertain whether their outpatient providers have sufficient information about the hospitalization to properly advise them. The authors propose using photo “face sheets” to improve caregiver identification of healthcare provider roles, including families in hospital committees, improving transition communication between inpatient and outpatient healthcare providers through timely faxed discharge summaries and telephone calls, and informing families about such communications with their outpatient providers.

These are important suggestions. However, in order to move from promoting communication alone to promoting true partnership in care, there are additional steps that providers can take to fully engage families in hospital and discharge communications.

Meaningful family engagement in hospital communications—eg, during family-centered rounds (FCRs)—has been associated with improved patient safety and experience.^10-12 To further enhance family partnership in care, we would make the following 3 suggestions for hospitals and healthcare providers: (1) focus on health literacy in all communications with families, (2) work towards shared decision making (SDM), and (3) make discharges family-centered.

In order to partner with one another, families and healthcare providers need to speak a common language. A key way to ensure that families and providers speak a common language is for providers to espouse good health literacy principles. Health literacy is the “capacity to obtain, process, and understand basic health information and services to make appropriate health decisions.”¹³ Health literacy is dynamic, varying based on medical problem, provider, and healthcare system.¹⁴ Overall, only 12% of United States adults possess the health literacy skills required to navigate our complex healthcare system.^15,16 Stress, illness, and other factors can compromise the ability of even these individuals to process and utilize health information. Yet health literacy is routinely overestimated by providers.^17-19

To optimize communication with families, providers should use “universal health literacy precautions”¹⁶ with all patients, not just those believed to need extra assistance, in both verbal (eg, FCRs) and written communications (eg, discharge instructions).¹⁶ Providers should speak in plain, nonmedical language, be specific and concrete, and have families engage in “teach-back” (ie, state in their own words their understanding of the plan). They should focus on what families “need to know” rather than what is “good to know.” They should use simpler sentence structure and “chunk and check”²⁰ (ie, provide small, “bite-sized” pieces of information and check for understanding by using teach-back).²¹ In writing, they should use simpler sentence structure, bullet points, active statements, and be cognizant of reading level, medical jargon, and word choice (eg, “has a fever” instead of “febrile”). It is worth recognizing that even highly educated, highly literate families—not least of all those who are physicians and nurses themselves—can benefit from universal health literacy precautions because the ability to process and grasp information is dynamic and can be markedly lower than usual when faced with the illness of a loved one.

At a systematic level, medical schools, nursing schools, residency training programs, and continuing education should include health literacy training in their curricula. While learning to speak the language of medicine is an important part of medical education, the next step is learning to “unspeak” it, a challenging but important charge to promote partnership.

SDM is the process by which providers and patients make decisions together by balancing clinical evidence with patient preferences and values.²² However, despite providers believing they are engaging in SDM,^23,24 families report they are often not as involved in SDM as they would like.^24-26 Indeed, most hospital communications with families, including FCRs and discharge instructions, typically emphasize information sharing, not SDM. SDM tends to be more commonly applied in outpatient settings.²⁷ To encourage SDM in the hospital setting, patients and families should not only understand communication during FCRs and at discharge but should be encouraged to be active participants in developing care plans,²⁶ no matter how minor the decisions involved.²⁸ SDM can be applied to a variety of discussions, both during hospitalization (eg, initiation of antibiotics, transition from intravenous to oral medications, pursuing imaging) and at discharge (eg, assessing discharge readiness, deciding duration of therapy, formulating follow-up recommendations). Providers will benefit from incorporating information from personal and medical histories that only families possess, resulting in more informed and potentially safer care plans that may be more likely to fit into the family’s life at home. SDM can also ensure patient and family “buy-in” and increase the likelihood of compliance with the shared plan.

Discharge processes often involve multiple redundancies and parallel processes that fail to actively involve families or promote transparency.²⁹ Discharge summaries are typically written in medical jargon and intended for the outpatient provider (who may not receive them in a timely fashion), not the family.^30-32 Separate discharge instructions are often provided to families without sufficient attention to health literacy, contingency planning, or individualization (eg, a generic asthma fact sheet).³⁰ Outpatient providers are not always contacted directly about the hospitalization, nor are families always informed when providers are contacted, as Solan et al. describe.

Providers can apply lessons from FCRs to discharge processes, pursuing a similar family-centered, interprofessional approach promoting partnership and transparency. Just as providers engage families during discussions on FCRs, they can engage families in discharge conversations with outpatient providers and nursing colleagues. Indeed, Berry et al. propose a discharge framework that emphasizes involvement of and dialogue between patients, families, and providers as they systematically develop and assess plans for discharge and postdischarge care.³³ To accomplish this, inpatient providers can copy families on discharge summaries and other correspondence with outpatient providers (eg, through secure emails or open-source notes such as OpenNotes^34-36). Moreover, particularly for complex discharges, inpatient providers can call outpatient providers in the family’s presence or invite outpatient providers to join—via telephone or videoconference—day-of-discharge FCRs or discharge huddles. Such efforts require logistical and pragmatic considerations, as well as culture change, but are not insurmountable and may help address many family concerns around peridischarge communication and care. Such efforts may also promote accountability on the part of families and providers alike, thereby ensuring that families are truly engaged as vigilant partners in care.

As one of us (SC) reflected once when considering her experience navigating healthcare as a parent of 2 children with cystic fibrosis, “We have to make it easier for families to be a true part of their children’s care. When patients and families are true members of the medical team, care is more informed, more targeted, and more safe for everyone.”

Disclosure: Dr. Landrigan has consulted with and holds equity in the I-PASS Patient Safety Institute, a company that seeks to train institutions in best handoff practices and aid in their implementation. Dr. Landrigan is supported in part by the Children’s Hospital Association for his work as an Executive Council member of the Pediatric Research in Inpatient Settings (PRIS) network. Dr. Landrigan has also served as a paid consultant to Virgin Pulse to help develop a Sleep and Health Program. In addition, Dr. Landrigan has received monetary awards, honoraria, and travel reimbursement from multiple academic and professional organizations for teaching and consulting on sleep deprivation, physician performance, handoffs, and safety and has served as an expert witness in cases regarding patient safety and sleep deprivation.

Communication failures are a leading cause of sentinel events, the most serious adverse events that occur in hospitals.¹ Interventions to improve patient safety have focused on communication between healthcare providers.^2-4 Interventions focusing on communication between providers and families or other patient caregivers are under-studied.^5,6 Given their availability, proximity, historical knowledge, and motivation for a good outcome,⁷ families can play a vital role as “vigilant partners”⁸ in promoting hospital communication and safety.

In this month’s Journal of Hospital Medicine, Solan et al. conducted focus groups and interviews of 61 caregivers of hospitalized pediatric patients at 30 days after discharge to assess their perceptions of communication during hospitalization and discharge home.⁹ They identified several caregiver themes pertaining to communication between the inpatient medical team and families, communication challenges due to the teaching hospital environment, and communication between providers. Caregiver concerns included feeling out of the loop, excessive provider use of medical jargon, confusing messages on rounds, and inadequate communication between inpatient and outpatient providers.

The manuscript serves both to uncover family concerns that may be underappreciated by clinicians and suggest some potential solutions. For instance, caregivers can be apprehensive about whom to call for postdischarge advice because they are sometimes uncertain whether their outpatient providers have sufficient information about the hospitalization to properly advise them. The authors propose using photo “face sheets” to improve caregiver identification of healthcare provider roles, including families in hospital committees, improving transition communication between inpatient and outpatient healthcare providers through timely faxed discharge summaries and telephone calls, and informing families about such communications with their outpatient providers.

These are important suggestions. However, in order to move from promoting communication alone to promoting true partnership in care, there are additional steps that providers can take to fully engage families in hospital and discharge communications.

Meaningful family engagement in hospital communications—eg, during family-centered rounds (FCRs)—has been associated with improved patient safety and experience.^10-12 To further enhance family partnership in care, we would make the following 3 suggestions for hospitals and healthcare providers: (1) focus on health literacy in all communications with families, (2) work towards shared decision making (SDM), and (3) make discharges family-centered.

In order to partner with one another, families and healthcare providers need to speak a common language. A key way to ensure that families and providers speak a common language is for providers to espouse good health literacy principles. Health literacy is the “capacity to obtain, process, and understand basic health information and services to make appropriate health decisions.”¹³ Health literacy is dynamic, varying based on medical problem, provider, and healthcare system.¹⁴ Overall, only 12% of United States adults possess the health literacy skills required to navigate our complex healthcare system.^15,16 Stress, illness, and other factors can compromise the ability of even these individuals to process and utilize health information. Yet health literacy is routinely overestimated by providers.^17-19

To optimize communication with families, providers should use “universal health literacy precautions”¹⁶ with all patients, not just those believed to need extra assistance, in both verbal (eg, FCRs) and written communications (eg, discharge instructions).¹⁶ Providers should speak in plain, nonmedical language, be specific and concrete, and have families engage in “teach-back” (ie, state in their own words their understanding of the plan). They should focus on what families “need to know” rather than what is “good to know.” They should use simpler sentence structure and “chunk and check”²⁰ (ie, provide small, “bite-sized” pieces of information and check for understanding by using teach-back).²¹ In writing, they should use simpler sentence structure, bullet points, active statements, and be cognizant of reading level, medical jargon, and word choice (eg, “has a fever” instead of “febrile”). It is worth recognizing that even highly educated, highly literate families—not least of all those who are physicians and nurses themselves—can benefit from universal health literacy precautions because the ability to process and grasp information is dynamic and can be markedly lower than usual when faced with the illness of a loved one.

At a systematic level, medical schools, nursing schools, residency training programs, and continuing education should include health literacy training in their curricula. While learning to speak the language of medicine is an important part of medical education, the next step is learning to “unspeak” it, a challenging but important charge to promote partnership.

SDM is the process by which providers and patients make decisions together by balancing clinical evidence with patient preferences and values.²² However, despite providers believing they are engaging in SDM,^23,24 families report they are often not as involved in SDM as they would like.^24-26 Indeed, most hospital communications with families, including FCRs and discharge instructions, typically emphasize information sharing, not SDM. SDM tends to be more commonly applied in outpatient settings.²⁷ To encourage SDM in the hospital setting, patients and families should not only understand communication during FCRs and at discharge but should be encouraged to be active participants in developing care plans,²⁶ no matter how minor the decisions involved.²⁸ SDM can be applied to a variety of discussions, both during hospitalization (eg, initiation of antibiotics, transition from intravenous to oral medications, pursuing imaging) and at discharge (eg, assessing discharge readiness, deciding duration of therapy, formulating follow-up recommendations). Providers will benefit from incorporating information from personal and medical histories that only families possess, resulting in more informed and potentially safer care plans that may be more likely to fit into the family’s life at home. SDM can also ensure patient and family “buy-in” and increase the likelihood of compliance with the shared plan.

Discharge processes often involve multiple redundancies and parallel processes that fail to actively involve families or promote transparency.²⁹ Discharge summaries are typically written in medical jargon and intended for the outpatient provider (who may not receive them in a timely fashion), not the family.^30-32 Separate discharge instructions are often provided to families without sufficient attention to health literacy, contingency planning, or individualization (eg, a generic asthma fact sheet).³⁰ Outpatient providers are not always contacted directly about the hospitalization, nor are families always informed when providers are contacted, as Solan et al. describe.

Providers can apply lessons from FCRs to discharge processes, pursuing a similar family-centered, interprofessional approach promoting partnership and transparency. Just as providers engage families during discussions on FCRs, they can engage families in discharge conversations with outpatient providers and nursing colleagues. Indeed, Berry et al. propose a discharge framework that emphasizes involvement of and dialogue between patients, families, and providers as they systematically develop and assess plans for discharge and postdischarge care.³³ To accomplish this, inpatient providers can copy families on discharge summaries and other correspondence with outpatient providers (eg, through secure emails or open-source notes such as OpenNotes^34-36). Moreover, particularly for complex discharges, inpatient providers can call outpatient providers in the family’s presence or invite outpatient providers to join—via telephone or videoconference—day-of-discharge FCRs or discharge huddles. Such efforts require logistical and pragmatic considerations, as well as culture change, but are not insurmountable and may help address many family concerns around peridischarge communication and care. Such efforts may also promote accountability on the part of families and providers alike, thereby ensuring that families are truly engaged as vigilant partners in care.

As one of us (SC) reflected once when considering her experience navigating healthcare as a parent of 2 children with cystic fibrosis, “We have to make it easier for families to be a true part of their children’s care. When patients and families are true members of the medical team, care is more informed, more targeted, and more safe for everyone.”

Disclosure: Dr. Landrigan has consulted with and holds equity in the I-PASS Patient Safety Institute, a company that seeks to train institutions in best handoff practices and aid in their implementation. Dr. Landrigan is supported in part by the Children’s Hospital Association for his work as an Executive Council member of the Pediatric Research in Inpatient Settings (PRIS) network. Dr. Landrigan has also served as a paid consultant to Virgin Pulse to help develop a Sleep and Health Program. In addition, Dr. Landrigan has received monetary awards, honoraria, and travel reimbursement from multiple academic and professional organizations for teaching and consulting on sleep deprivation, physician performance, handoffs, and safety and has served as an expert witness in cases regarding patient safety and sleep deprivation.

Communication failures are a leading cause of sentinel events, the most serious adverse events that occur in hospitals.¹ Interventions to improve patient safety have focused on communication between healthcare providers.^2-4 Interventions focusing on communication between providers and families or other patient caregivers are under-studied.^5,6 Given their availability, proximity, historical knowledge, and motivation for a good outcome,⁷ families can play a vital role as “vigilant partners”⁸ in promoting hospital communication and safety.

In this month’s Journal of Hospital Medicine, Solan et al. conducted focus groups and interviews of 61 caregivers of hospitalized pediatric patients at 30 days after discharge to assess their perceptions of communication during hospitalization and discharge home.⁹ They identified several caregiver themes pertaining to communication between the inpatient medical team and families, communication challenges due to the teaching hospital environment, and communication between providers. Caregiver concerns included feeling out of the loop, excessive provider use of medical jargon, confusing messages on rounds, and inadequate communication between inpatient and outpatient providers.

The manuscript serves both to uncover family concerns that may be underappreciated by clinicians and suggest some potential solutions. For instance, caregivers can be apprehensive about whom to call for postdischarge advice because they are sometimes uncertain whether their outpatient providers have sufficient information about the hospitalization to properly advise them. The authors propose using photo “face sheets” to improve caregiver identification of healthcare provider roles, including families in hospital committees, improving transition communication between inpatient and outpatient healthcare providers through timely faxed discharge summaries and telephone calls, and informing families about such communications with their outpatient providers.

These are important suggestions. However, in order to move from promoting communication alone to promoting true partnership in care, there are additional steps that providers can take to fully engage families in hospital and discharge communications.

Meaningful family engagement in hospital communications—eg, during family-centered rounds (FCRs)—has been associated with improved patient safety and experience.^10-12 To further enhance family partnership in care, we would make the following 3 suggestions for hospitals and healthcare providers: (1) focus on health literacy in all communications with families, (2) work towards shared decision making (SDM), and (3) make discharges family-centered.

In order to partner with one another, families and healthcare providers need to speak a common language. A key way to ensure that families and providers speak a common language is for providers to espouse good health literacy principles. Health literacy is the “capacity to obtain, process, and understand basic health information and services to make appropriate health decisions.”¹³ Health literacy is dynamic, varying based on medical problem, provider, and healthcare system.¹⁴ Overall, only 12% of United States adults possess the health literacy skills required to navigate our complex healthcare system.^15,16 Stress, illness, and other factors can compromise the ability of even these individuals to process and utilize health information. Yet health literacy is routinely overestimated by providers.^17-19

To optimize communication with families, providers should use “universal health literacy precautions”¹⁶ with all patients, not just those believed to need extra assistance, in both verbal (eg, FCRs) and written communications (eg, discharge instructions).¹⁶ Providers should speak in plain, nonmedical language, be specific and concrete, and have families engage in “teach-back” (ie, state in their own words their understanding of the plan). They should focus on what families “need to know” rather than what is “good to know.” They should use simpler sentence structure and “chunk and check”²⁰ (ie, provide small, “bite-sized” pieces of information and check for understanding by using teach-back).²¹ In writing, they should use simpler sentence structure, bullet points, active statements, and be cognizant of reading level, medical jargon, and word choice (eg, “has a fever” instead of “febrile”). It is worth recognizing that even highly educated, highly literate families—not least of all those who are physicians and nurses themselves—can benefit from universal health literacy precautions because the ability to process and grasp information is dynamic and can be markedly lower than usual when faced with the illness of a loved one.

At a systematic level, medical schools, nursing schools, residency training programs, and continuing education should include health literacy training in their curricula. While learning to speak the language of medicine is an important part of medical education, the next step is learning to “unspeak” it, a challenging but important charge to promote partnership.

SDM is the process by which providers and patients make decisions together by balancing clinical evidence with patient preferences and values.²² However, despite providers believing they are engaging in SDM,^23,24 families report they are often not as involved in SDM as they would like.^24-26 Indeed, most hospital communications with families, including FCRs and discharge instructions, typically emphasize information sharing, not SDM. SDM tends to be more commonly applied in outpatient settings.²⁷ To encourage SDM in the hospital setting, patients and families should not only understand communication during FCRs and at discharge but should be encouraged to be active participants in developing care plans,²⁶ no matter how minor the decisions involved.²⁸ SDM can be applied to a variety of discussions, both during hospitalization (eg, initiation of antibiotics, transition from intravenous to oral medications, pursuing imaging) and at discharge (eg, assessing discharge readiness, deciding duration of therapy, formulating follow-up recommendations). Providers will benefit from incorporating information from personal and medical histories that only families possess, resulting in more informed and potentially safer care plans that may be more likely to fit into the family’s life at home. SDM can also ensure patient and family “buy-in” and increase the likelihood of compliance with the shared plan.

Discharge processes often involve multiple redundancies and parallel processes that fail to actively involve families or promote transparency.²⁹ Discharge summaries are typically written in medical jargon and intended for the outpatient provider (who may not receive them in a timely fashion), not the family.^30-32 Separate discharge instructions are often provided to families without sufficient attention to health literacy, contingency planning, or individualization (eg, a generic asthma fact sheet).³⁰ Outpatient providers are not always contacted directly about the hospitalization, nor are families always informed when providers are contacted, as Solan et al. describe.

Providers can apply lessons from FCRs to discharge processes, pursuing a similar family-centered, interprofessional approach promoting partnership and transparency. Just as providers engage families during discussions on FCRs, they can engage families in discharge conversations with outpatient providers and nursing colleagues. Indeed, Berry et al. propose a discharge framework that emphasizes involvement of and dialogue between patients, families, and providers as they systematically develop and assess plans for discharge and postdischarge care.³³ To accomplish this, inpatient providers can copy families on discharge summaries and other correspondence with outpatient providers (eg, through secure emails or open-source notes such as OpenNotes^34-36). Moreover, particularly for complex discharges, inpatient providers can call outpatient providers in the family’s presence or invite outpatient providers to join—via telephone or videoconference—day-of-discharge FCRs or discharge huddles. Such efforts require logistical and pragmatic considerations, as well as culture change, but are not insurmountable and may help address many family concerns around peridischarge communication and care. Such efforts may also promote accountability on the part of families and providers alike, thereby ensuring that families are truly engaged as vigilant partners in care.

As one of us (SC) reflected once when considering her experience navigating healthcare as a parent of 2 children with cystic fibrosis, “We have to make it easier for families to be a true part of their children’s care. When patients and families are true members of the medical team, care is more informed, more targeted, and more safe for everyone.”

Disclosure: Dr. Landrigan has consulted with and holds equity in the I-PASS Patient Safety Institute, a company that seeks to train institutions in best handoff practices and aid in their implementation. Dr. Landrigan is supported in part by the Children’s Hospital Association for his work as an Executive Council member of the Pediatric Research in Inpatient Settings (PRIS) network. Dr. Landrigan has also served as a paid consultant to Virgin Pulse to help develop a Sleep and Health Program. In addition, Dr. Landrigan has received monetary awards, honoraria, and travel reimbursement from multiple academic and professional organizations for teaching and consulting on sleep deprivation, physician performance, handoffs, and safety and has served as an expert witness in cases regarding patient safety and sleep deprivation.

Pathogenic loss-of-function germline variants in the TP53 gene predispose children to acute lymphoblastic leukemia (ALL), and, later, to solid tumors that may be related to cancer therapy, according to results from a genetic sequencing study.

Researchers at St. Jude Children’s Hospital in Memphis have identified 49 unique variants of the gene among 3,801 children with newly diagnosed B-cell ALL; 22 variants were deemed pathogenic. Children with these variants were at a “dramatically higher risk” of secondary cancers, which occurred in 25% within 5 years of ALL treatment, compared with 0.7% among children without the pathogenic genetic signal, according to Maoxiang Qian, PhD, and colleagues. The report was published in the Journal of Clinical Oncology.

The increased risk of secondary cancers is probably related to a common characteristic of the pathogenic variants: the ablation of the p53-mediated DNA damage response. This increases the risk of the genotoxic therapy given during ALL treatment, according to the researchers.

“In fact, of the five patients with TP53 pathogenic variants who also had second cancers, two received irradiation therapy, including total body irradiation, and both subsequently developed solid tumors,” the researchers wrote. “The exact lifelong risk of second cancer in these patients is difficult to ascertain as many patients might have succumbed to relapsed ALL before they had the chance to develop second cancers.”

The research team conducted targeted sequencing of TP53 coding regions in 3,801 children who were enrolled in two trials sponsored by the Children’s Oncology Group (AALL0232 and P9900). They compared the results to TP53 mutations seen in almost 61,000 children enrolled in the Exome Aggregation Consortium (ExAC) cohort.

The researchers identified nine exonic nonsilent TP53 variants in the ALL cohort, all of which had an allele frequency of less than 0.5%. Of the variants, 22 were deemed pathogenic: Twelve showed a complete loss of transcriptional activity, three showed a partial loss of p53 function, and seven showed loss of the critical core DNA-binding domain in p53. The rest of the variants were deemed of unknown significance (VUS).

Pathogenic variants occurred in 26 children in the ALL cohort – significantly more often than in the control cohort (0.7% vs. 0.1%; odds ratio, 5.2). The VUS risk was not significantly elevated compared to controls, however.

Children with the pathogenic variants were significantly older at ALL diagnosis (15.5 vs. 6.6 years) and had significantly lower leukocyte count. Of the 26 with a pathogenic variant, 17 (65.4%) showed hypodiploidy in ALL blasts.

Pathogenic variants negatively affected ALL treatment outcomes, quadrupling the risk of lower event-free survival and lower overall survival (hazard ratio, 4.2 and 3.9, respectively) in both ALL cohorts.

Of the children with pathogenic variants, 14 experienced a pathological clinical event, including five ALL relapses and five second cancers, each accounting for 36% of all events.

“This pattern of events was dramatically different from that in patients with wild-type TP53 or VUS, for whom ALL relapse accounted for 75% of all events, with only 4% as second cancers,” the researchers wrote. “In fact, within hypodiploid ALL patients who experienced an event, the frequency of second cancer was significantly higher in those with TP53 pathogenic variants than in those without [50% vs. 5%], which additionally suggests that germline TP53 variation, instead of hypodiploid ALL, was the underlying cause of second cancers in these patients.”

The study was supported by grants from the National Institutes of Health and the American Lebanese Syrian Associated Charities. Dr. Qian reported having no financial disclosures. Other researchers reported funding from various pharmaceutical companies.

[email protected]

SOURCE: Qian et al. JCO 2018 Jan 4. doi: 10.1200/JCO.2017.75.5215

Pathogenic loss-of-function germline variants in the TP53 gene predispose children to acute lymphoblastic leukemia (ALL), and, later, to solid tumors that may be related to cancer therapy, according to results from a genetic sequencing study.

Researchers at St. Jude Children’s Hospital in Memphis have identified 49 unique variants of the gene among 3,801 children with newly diagnosed B-cell ALL; 22 variants were deemed pathogenic. Children with these variants were at a “dramatically higher risk” of secondary cancers, which occurred in 25% within 5 years of ALL treatment, compared with 0.7% among children without the pathogenic genetic signal, according to Maoxiang Qian, PhD, and colleagues. The report was published in the Journal of Clinical Oncology.

The increased risk of secondary cancers is probably related to a common characteristic of the pathogenic variants: the ablation of the p53-mediated DNA damage response. This increases the risk of the genotoxic therapy given during ALL treatment, according to the researchers.

“In fact, of the five patients with TP53 pathogenic variants who also had second cancers, two received irradiation therapy, including total body irradiation, and both subsequently developed solid tumors,” the researchers wrote. “The exact lifelong risk of second cancer in these patients is difficult to ascertain as many patients might have succumbed to relapsed ALL before they had the chance to develop second cancers.”

The research team conducted targeted sequencing of TP53 coding regions in 3,801 children who were enrolled in two trials sponsored by the Children’s Oncology Group (AALL0232 and P9900). They compared the results to TP53 mutations seen in almost 61,000 children enrolled in the Exome Aggregation Consortium (ExAC) cohort.

The researchers identified nine exonic nonsilent TP53 variants in the ALL cohort, all of which had an allele frequency of less than 0.5%. Of the variants, 22 were deemed pathogenic: Twelve showed a complete loss of transcriptional activity, three showed a partial loss of p53 function, and seven showed loss of the critical core DNA-binding domain in p53. The rest of the variants were deemed of unknown significance (VUS).

Pathogenic variants occurred in 26 children in the ALL cohort – significantly more often than in the control cohort (0.7% vs. 0.1%; odds ratio, 5.2). The VUS risk was not significantly elevated compared to controls, however.

Children with the pathogenic variants were significantly older at ALL diagnosis (15.5 vs. 6.6 years) and had significantly lower leukocyte count. Of the 26 with a pathogenic variant, 17 (65.4%) showed hypodiploidy in ALL blasts.

Pathogenic variants negatively affected ALL treatment outcomes, quadrupling the risk of lower event-free survival and lower overall survival (hazard ratio, 4.2 and 3.9, respectively) in both ALL cohorts.

Of the children with pathogenic variants, 14 experienced a pathological clinical event, including five ALL relapses and five second cancers, each accounting for 36% of all events.

“This pattern of events was dramatically different from that in patients with wild-type TP53 or VUS, for whom ALL relapse accounted for 75% of all events, with only 4% as second cancers,” the researchers wrote. “In fact, within hypodiploid ALL patients who experienced an event, the frequency of second cancer was significantly higher in those with TP53 pathogenic variants than in those without [50% vs. 5%], which additionally suggests that germline TP53 variation, instead of hypodiploid ALL, was the underlying cause of second cancers in these patients.”

The study was supported by grants from the National Institutes of Health and the American Lebanese Syrian Associated Charities. Dr. Qian reported having no financial disclosures. Other researchers reported funding from various pharmaceutical companies.

[email protected]

SOURCE: Qian et al. JCO 2018 Jan 4. doi: 10.1200/JCO.2017.75.5215

Pathogenic loss-of-function germline variants in the TP53 gene predispose children to acute lymphoblastic leukemia (ALL), and, later, to solid tumors that may be related to cancer therapy, according to results from a genetic sequencing study.

Researchers at St. Jude Children’s Hospital in Memphis have identified 49 unique variants of the gene among 3,801 children with newly diagnosed B-cell ALL; 22 variants were deemed pathogenic. Children with these variants were at a “dramatically higher risk” of secondary cancers, which occurred in 25% within 5 years of ALL treatment, compared with 0.7% among children without the pathogenic genetic signal, according to Maoxiang Qian, PhD, and colleagues. The report was published in the Journal of Clinical Oncology.

The increased risk of secondary cancers is probably related to a common characteristic of the pathogenic variants: the ablation of the p53-mediated DNA damage response. This increases the risk of the genotoxic therapy given during ALL treatment, according to the researchers.

“In fact, of the five patients with TP53 pathogenic variants who also had second cancers, two received irradiation therapy, including total body irradiation, and both subsequently developed solid tumors,” the researchers wrote. “The exact lifelong risk of second cancer in these patients is difficult to ascertain as many patients might have succumbed to relapsed ALL before they had the chance to develop second cancers.”

The research team conducted targeted sequencing of TP53 coding regions in 3,801 children who were enrolled in two trials sponsored by the Children’s Oncology Group (AALL0232 and P9900). They compared the results to TP53 mutations seen in almost 61,000 children enrolled in the Exome Aggregation Consortium (ExAC) cohort.

The researchers identified nine exonic nonsilent TP53 variants in the ALL cohort, all of which had an allele frequency of less than 0.5%. Of the variants, 22 were deemed pathogenic: Twelve showed a complete loss of transcriptional activity, three showed a partial loss of p53 function, and seven showed loss of the critical core DNA-binding domain in p53. The rest of the variants were deemed of unknown significance (VUS).

Pathogenic variants occurred in 26 children in the ALL cohort – significantly more often than in the control cohort (0.7% vs. 0.1%; odds ratio, 5.2). The VUS risk was not significantly elevated compared to controls, however.

Children with the pathogenic variants were significantly older at ALL diagnosis (15.5 vs. 6.6 years) and had significantly lower leukocyte count. Of the 26 with a pathogenic variant, 17 (65.4%) showed hypodiploidy in ALL blasts.

Pathogenic variants negatively affected ALL treatment outcomes, quadrupling the risk of lower event-free survival and lower overall survival (hazard ratio, 4.2 and 3.9, respectively) in both ALL cohorts.

Of the children with pathogenic variants, 14 experienced a pathological clinical event, including five ALL relapses and five second cancers, each accounting for 36% of all events.

“This pattern of events was dramatically different from that in patients with wild-type TP53 or VUS, for whom ALL relapse accounted for 75% of all events, with only 4% as second cancers,” the researchers wrote. “In fact, within hypodiploid ALL patients who experienced an event, the frequency of second cancer was significantly higher in those with TP53 pathogenic variants than in those without [50% vs. 5%], which additionally suggests that germline TP53 variation, instead of hypodiploid ALL, was the underlying cause of second cancers in these patients.”

The study was supported by grants from the National Institutes of Health and the American Lebanese Syrian Associated Charities. Dr. Qian reported having no financial disclosures. Other researchers reported funding from various pharmaceutical companies.

[email protected]

SOURCE: Qian et al. JCO 2018 Jan 4. doi: 10.1200/JCO.2017.75.5215

Provision of high-quality, high-value medical care hinges upon effective communication. During a hospitalization, critical information is communicated between patients, caregivers, and providers multiple times each day. This can cause inconsistent and misinterpreted messages, leaving ample room for error.¹ The Joint Commission notes that communication failures occurring between medical providers account for ~60% of all sentinel or serious adverse events that result in death or harm to a patient.² Communication that occurs between patients and/or their caregivers and medical providers is also critically important. The content and consistency of this communication is highly valued by patients and providers and can affect patient outcomes during hospitalizations and during transitions to home.^3,4 Still, the multifactorial, complex nature of communication in the pediatric inpatient setting is not well understood.^5,6

During hospitalization, communication happens continuously during both daytime and nighttime hours. It also precedes the particularly fragile period of transition from hospital to home. Studies have shown that nighttime communication between caregivers and medical providers (ie, nurses and physicians), as well as caregivers’ perceptions of interactions that occur between nurses and physicians, may be closely linked to that caregiver’s satisfaction and perceived quality of care.^6,7 Communication that occurs between inpatient and outpatient providers is also subject to barriers (eg, limited availability for direct communication)^8-12; studies have shown that patient and/or caregiver satisfaction has also been tied to perceptions of this communication.^13,14 Moreover, a caregiver’s ability to understand diagnoses and adhere to postdischarge care plans is intimately tied to communication during the hospitalization and at discharge. Although many improvement efforts have aimed to enhance communication during these vulnerable time periods,^3,15,16 there remains much work to be done.^1,10,12

The many facets and routes of communication, and the multiple stakeholders involved, make improvement efforts challenging. We believe that more effective communication strategies could result from a deeper understanding of how caregivers view communication successes and challenges during a hospitalization. We see this as key to developing meaningful interventions that are directed towards improving communication and, by extension, patient satisfaction and safety. Here, we sought to extend findings from a broader qualitative study¹⁷ by developing an in-depth understanding of communication issues experienced by families during their child’s hospitalization and during the transition to home.

Setting

The analyses presented here emerged from the Hospital to Home Outcomes Study (H2O). The first objective of H2O was to explore the caregiver perspective on hospital-to-home transitions. Here, we present the results related to caregiver perspectives of communication, while broader results of our qualitative investigation have been published elsewhere.¹⁷ This objective informed the latter 2 aims of the H2O study, which were to modify an existing nurse-led transitional home visit (THV) program and to study the effectiveness of the modified THV on reutilization and patient-specific outcomes via a randomized control trial. The specifics of the H2O protocol and design have been presented elsewhere.¹⁸

H2O was approved by the Institutional Review Board at Cincinnati Children’s Hospital Medical Center (CCHMC), a free-standing, academic children’s hospital with ~600 inpatient beds. This teaching hospital has >800 total medical students, residents, and fellows. Approximately 8000 children are hospitalized annually at CCHMC for general pediatric conditions, with ~85% of such admissions staffed by hospitalists from the Division of Hospital Medicine. The division is composed of >40 providers who devote the majority of their clinical time to the hospital medicine service; 15 additional providers work on the hospital medicine service but have primary clinical responsibilities in another division.

Family-centered rounds (FCR) are the standard of care at CCHMC, involving family members at the bedside to discuss patient care plans and diagnoses with the medical team.¹⁹ On a typical day, a team conducting FCR is composed of 1 attending, 1 fellow, 2 to 3 pediatric residents, 2 to 3 medical students, a charge nurse or bedside nurse, and a pharmacist. Other ancillary staff, such as social workers, care coordinators, nurse practitioners, or dieticians, may also participate on rounds, particularly for children with greater medical complexity.

Population

Caregivers of children discharged with acute medical conditions were eligible for recruitment if they were English-speaking (we did not have access to interpreter services during focus groups/interviews), had a child admitted to 1 of 3 services (hospital medicine, neurology, or neurosurgery), and could attend a focus group within 30 days of the child’s discharge. The majority of participants had a child admitted to hospital medicine; however, caregivers with a generally healthy child admitted to either neurology or neurosurgery were eligible to participate in the study.

Study Design

As presented elsewhere,^17,20 we used focus groups and individual in-depth interviews to generate consensus themes about patient and caregiver experiences during the transition from hospital to home. Because there is evidence suggesting that focus group participants are more willing to talk openly when among others of similar backgrounds, we stratified the sample by the family’s estimated socioeconomic status.^21,22 Socioeconomic status was estimated by identifying the poverty rate in the census tract in which each participant lived. Census tracts, relatively homogeneous areas of ~4000 individuals, have been previously shown to effectively detect socioeconomic gradients.^23-26 Here, we separated participants into 2 socioeconomically distinct groupings (those in census tracts where <15% or ≥15% of the population lived below the federal poverty level).²⁶ This cut point ensured an equivalent number of eligible participants within each stratum and diversity within our sample.

Data Collection

Caregivers were recruited on the inpatient unit during their child’s hospitalization. Participants then returned to CCHMC facilities for the focus group within 30 days of discharge. Though efforts were made to enhance participation by scheduling sessions at multiple sites and during various days and times of the week, 4 sessions yielded just 1 participant; thus, the format for those became an individual interview. Childcare was provided, and participants received a gift card for their participation.

An open-ended, semistructured question guide,¹⁷ developed de novo by the research team, directed the discussion for focus groups and interviews. As data collection progressed, the question guide was adapted to incorporate new issues raised by participants. Questions broadly focused on aspects of the inpatient experience, discharge processes, and healthcare system and family factors thought to be most relevant to patient- and family-centered outcomes. Communication-related questions addressed information shared with families from the medical team about discharge, diagnoses, instructions, and care plans. An experienced moderator and qualitative research methodologist (SNS) used probes to further elucidate responses and expand discussion by participants. Sessions were held in private conference rooms, lasted ~90 minutes, were audiotaped, and were transcribed verbatim. Identifiers were stripped and transcripts were reviewed for accuracy. After conducting 11 focus groups (generally composed of 5-10 participants) and 4 individual interviews, the research team determined that theoretical saturation²⁷ was achieved, and recruitment was suspended.

Data Analysis

An inductive, thematic approach was used for analysis.²⁷ Transcripts were independently reviewed by a multidisciplinary team of 4 researchers, including 2 pediatricians (LGS and AFB), a clinical research coordinator (SAS), and a qualitative research methodologist (SNS). The study team identified emerging concepts and themes related to the transition from hospital to home; themes related to communication during hospitalization are presented here.

During the first phase of analysis, investigators independently read transcripts and later convened to identify and define initial concepts and themes. A preliminary codebook was then designed. Investigators continued to review and code transcripts independently, meeting regularly to discuss coding decisions collaboratively, resolving differences through consensus.²⁸ As patterns in the data became apparent, the codebook was modified iteratively, adding, subtracting, and refining codes as needed and grouping related codes. Results were reviewed with key stakeholders, including parents, inpatient and outpatient pediatricians, and home health nurses, throughout the analytic process.^27,28 Coded data were maintained in an electronic database accessible only to study personnel.

Participants

Resulting Themes

Analyses revealed the following 3 major communication-related themes with associated subthemes: (1) experiences that affect caregiver perceptions of communication between the inpatient medical team and families, (2) communication challenges for caregivers related to a teaching hospital environment, and (3) caregiver perceptions of communication between medical providers. Each theme (and subtheme) is explored below with accompanying verbatim quotes in the narrative and the tables.

Major Theme 1: Experiences that Affect Caregiver Perceptions of Communication Between the Inpatient Medical Team and Families

In contrast, some of the negative experiences shared by participants related to feeling excluded from discussions about their child’s care. One participant said, “They tell you…as much as they want to tell you. They don’t fully inform you on things.” Additionally, concerns were voiced about insufficient time for face-to-face discussions with physicians: “I forget what I have to say and it’s something really, really important…But now, my doctor is going, you can’t get the doctor back.” Finally, participants discussed how the use of medical jargon often made it more difficult to understand things, especially for those not in the medical field.

Major Theme 2: Communication Challenges for Caregivers Related to a Teaching Hospital Environment

Major Theme 3: Caregiver Perceptions of Communication Between Medical Providers

Perceptions were not isolated to the inpatient setting. Based on their experiences, caregivers similarly described their sense of how inpatient and outpatient providers were communicating with each other. In some cases, it was clear that good communication, as perceived by the participant, had occurred in situations in which the primary care physician knew “everything” about the hospitalization when they saw the patient in follow-up. One participant described, “We didn’t even realize at the time, [the medical team] had actually called our doctor and filled them in on our situation, and we got [to the follow up visit]…He already knew the entire situation.” There were others, however, who shared their uncertainty about whether the information exchange about their child’s hospitalization had actually occurred. They, therefore, voiced apprehension around who to call for advice after discharge; would their outpatient provider have their child’s hospitalization history and be able to properly advise them?

Communication during a hospitalization and at transition from hospital to home happens in both formal and informal ways; it is a vital component of appropriate, effective patient care. When done poorly, it has the potential to negatively affect a patient’s safety, care, and key outcomes.² During a hospitalization, the multifaceted nature of communication and multidisciplinary approach to care provision can create communication challenges and make fixing challenges difficult. In order to more comprehensively move toward mitigation, it is important to gather perspectives of key stakeholders, such as caregivers. Caregivers are an integral part of their child’s care during the hospitalization and particularly at home during their child’s recovery. They are also a valued member of the team, particularly in this era of family-centered care.^19,29 The perspectives of the caregivers presented here identified both successes and challenges of their communication experiences with the medical team during their child’s hospitalization. These perspectives included experiences affecting perceptions of communication between the inpatient medical team and families; communication related to the teaching hospital environment, including confusing messages associated with large multidisciplinary teams, aspects of FCR, and confusion about medical team member roles; and caregivers’ perceptions of communication between providers in and out of the hospital, including types of communication caregivers observed or believed occurred between medical providers. We believe that these qualitative results are crucial to developing better, more targeted interventions to improve communication.

Maintaining a healthy and productive relationship with patients and their caregivers is critical to providing comprehensive and safe patient care. As supported in the literature, we found that when caregivers were included in conversations, they felt appreciated and valued; in addition, when answers were not directly shared by providers or there were lingering questions, nurses often served as “interpreters.”^29,30 Indeed, nurses were seen as a critical touchpoint for many participants, individuals that could not only answer questions but also be a trusted source of information. Supporting such a relationship, and helping enhance the relationship between the family and other team members, may be particularly important considering the degree to which a hospitalization can stress a patient, caregiver, and family.^31-34 Developing rapport with families and facilitating relationships with the inclusion of nursing during FCR can be particularly helpful. Though this can be challenging with the many competing priorities of medical providers and the fast-paced, acute nature of inpatient care, making an effort to include nursing staff on rounds can cut down on confusion and assist the family in understanding care plans. This, in turn, can minimize the stress associated with hospitalization and improve the patient and family experience.

While academic institutions’ resources and access to subspecialties are often thought to be advantageous, there are other challenges inherent to providing care in such complex environments. Some caregivers cited confusion related to large teams of providers with, to them, indistinguishable roles asking redundant questions. These experiences affected their perceptions of FCR, generally leading to a fixation on its overwhelming aspects. Certain caregivers highlighted that FCR caused them, and their child, to feel overwhelmed and more confused about the plan for the day. It is important to find ways to mitigate these feelings while simultaneously continuing to support the inclusion of caregivers during their child’s hospitalization and understanding of care plans. Some initiatives (in addition to including nursing on FCR as discussed above) focus on improving the ways in which providers communicate with families during rounds and throughout the day, seeking to decrease miscommunications and medical errors while also striving for better quality of care and patient/family satisfaction.³⁵ Other initiatives seek to clarify identities and roles of the often large and confusing medical team. One such example of this is the development of a face sheet tool, which provides families with medical team members’ photos and role descriptions. Unaka et al.³⁶ found that the use of the face sheet tool improved the ability of caregivers to correctly identify providers and their roles. Thinking beyond interventions at the bedside, it is also important to include caregivers on higher level committees within the institution, such as on family advisory boards and/or peer support groups, to inform systems-wide interventions that support the tenants of family-centered care.²⁹ Efforts such as these are worth trialing in order to improve the patient and family experience and quality of communication.

Multiple studies have evaluated the challenges with ensuring consistent and useful handoffs across the inpatient-to-outpatient transition,^8-10,12 but few have looked at it from the perspective of the caregiver.¹³ After leaving the hospital to care for their recovering child, caregivers often feel overwhelmed; they may want, or need, to rely on the support of others in the outpatient environment. This support can be enhanced when outpatient providers are intimately aware of what occurred during the hospitalization; trust erodes if this is not the case. Given the value caregivers place on this communication occurring and occurring well, interventions supporting this communication are critical. Furthermore, as providers, we should also inform families that communication with outpatient providers is happening. Examples of efforts that have worked to improve the quality and consistency of communication with outpatient providers include improving discharge summary documentation, ensuring timely faxing of documentation to outpatient providers, and reliably making phone calls to outpatient providers.^37-39 These types of interventions seek to bridge the gap between inpatient and outpatient care and facilitate a smooth transfer of information in order to provide optimal quality of care and avoid undesired outcomes (eg, emergency department revisits, readmissions, medication errors, etc) and can be adopted by institutions to address the issue of communication between inpatient and outpatient providers.

We acknowledge limitations to our study. This was done at a single academic institution with only English-speaking participants. Thus, our results may not be reflective of caregivers of children cared for in different, more ethnically or linguistically diverse settings. The patient population at CCHMC, however, is diverse both demographically and clinically, which was reflected in the composition of our focus groups and interviews. Additionally, the inclusion of participants who received a nurse home visit after discharge may limit generalizability. However, only 4 participants had a nurse home visit; thus, the overwhelming majority of participants did not receive such an intervention. We also acknowledge that those willing to participate may have differed from nonparticipants, specifically sharing more positive experiences. We believe that our sampling strategy and use of an unbiased, nonhospital affiliated moderator minimized this possibility. Recall bias is possible, as participants were asked to reflect back on a discharge experience occurring in their past. We attempted to minimize this by holding sessions no more than 30 days from the day of discharge. Finally, we present data on caregivers’ perception of communication and not directly observed communication occurrences. Still, we expect that perception is powerful in and of itself, relevant to both outcomes and to interventions.

Communication during hospitalization influences how caregivers understand diagnoses and care plans. Communication perceived as effective fosters mutual understandings and positive relationships with the potential to result in better care and improved outcomes. Communication perceived as ineffective negatively affects experiences of patients and their caregivers and can adversely affect patient outcomes. Learning from caregivers’ experiences with communication during their child’s hospitalization can help identify modifiable factors and inform strategies to improve communication, support families through hospitalization, and facilitate a smooth reentry home.

This manuscript is submitted on behalf of the H2O study group: Katherine A. Auger, MD, MSc, JoAnne Bachus, BSN, Monica L. Borell, BSN, Lenisa V. Chang, MA, PhD, Jennifer M. Gold, BSN, Judy A. Heilman, RN, Joseph A. Jabour, BS, Jane C. Khoury, PhD, Margo J. Moore, BSN, CCRP, Rita H. Pickler, PNP, PhD, Anita N. Shah, DO, Angela M. Statile, MD, MEd, Heidi J. Sucharew, PhD, Karen P. Sullivan, BSN, Heather L. Tubbs-Cooley, RN, PhD, Susan Wade-Murphy, MSN, and Christine M. White, MD, MAT.

Disclaimer

All statements in this report, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors, or Methodology Committee.

Disclosure

 This work was (partially) supported through a Patient-Centered Outcomes Research Institute (PCORI) Award (HIS-1306-0081). The authors have no financial relationships relevant to this article to disclose. The authors have no conflicts of interest to disclose.

Provision of high-quality, high-value medical care hinges upon effective communication. During a hospitalization, critical information is communicated between patients, caregivers, and providers multiple times each day. This can cause inconsistent and misinterpreted messages, leaving ample room for error.¹ The Joint Commission notes that communication failures occurring between medical providers account for ~60% of all sentinel or serious adverse events that result in death or harm to a patient.² Communication that occurs between patients and/or their caregivers and medical providers is also critically important. The content and consistency of this communication is highly valued by patients and providers and can affect patient outcomes during hospitalizations and during transitions to home.^3,4 Still, the multifactorial, complex nature of communication in the pediatric inpatient setting is not well understood.^5,6

During hospitalization, communication happens continuously during both daytime and nighttime hours. It also precedes the particularly fragile period of transition from hospital to home. Studies have shown that nighttime communication between caregivers and medical providers (ie, nurses and physicians), as well as caregivers’ perceptions of interactions that occur between nurses and physicians, may be closely linked to that caregiver’s satisfaction and perceived quality of care.^6,7 Communication that occurs between inpatient and outpatient providers is also subject to barriers (eg, limited availability for direct communication)^8-12; studies have shown that patient and/or caregiver satisfaction has also been tied to perceptions of this communication.^13,14 Moreover, a caregiver’s ability to understand diagnoses and adhere to postdischarge care plans is intimately tied to communication during the hospitalization and at discharge. Although many improvement efforts have aimed to enhance communication during these vulnerable time periods,^3,15,16 there remains much work to be done.^1,10,12

The many facets and routes of communication, and the multiple stakeholders involved, make improvement efforts challenging. We believe that more effective communication strategies could result from a deeper understanding of how caregivers view communication successes and challenges during a hospitalization. We see this as key to developing meaningful interventions that are directed towards improving communication and, by extension, patient satisfaction and safety. Here, we sought to extend findings from a broader qualitative study¹⁷ by developing an in-depth understanding of communication issues experienced by families during their child’s hospitalization and during the transition to home.

Setting

The analyses presented here emerged from the Hospital to Home Outcomes Study (H2O). The first objective of H2O was to explore the caregiver perspective on hospital-to-home transitions. Here, we present the results related to caregiver perspectives of communication, while broader results of our qualitative investigation have been published elsewhere.¹⁷ This objective informed the latter 2 aims of the H2O study, which were to modify an existing nurse-led transitional home visit (THV) program and to study the effectiveness of the modified THV on reutilization and patient-specific outcomes via a randomized control trial. The specifics of the H2O protocol and design have been presented elsewhere.¹⁸

H2O was approved by the Institutional Review Board at Cincinnati Children’s Hospital Medical Center (CCHMC), a free-standing, academic children’s hospital with ~600 inpatient beds. This teaching hospital has >800 total medical students, residents, and fellows. Approximately 8000 children are hospitalized annually at CCHMC for general pediatric conditions, with ~85% of such admissions staffed by hospitalists from the Division of Hospital Medicine. The division is composed of >40 providers who devote the majority of their clinical time to the hospital medicine service; 15 additional providers work on the hospital medicine service but have primary clinical responsibilities in another division.

Family-centered rounds (FCR) are the standard of care at CCHMC, involving family members at the bedside to discuss patient care plans and diagnoses with the medical team.¹⁹ On a typical day, a team conducting FCR is composed of 1 attending, 1 fellow, 2 to 3 pediatric residents, 2 to 3 medical students, a charge nurse or bedside nurse, and a pharmacist. Other ancillary staff, such as social workers, care coordinators, nurse practitioners, or dieticians, may also participate on rounds, particularly for children with greater medical complexity.

Population

Caregivers of children discharged with acute medical conditions were eligible for recruitment if they were English-speaking (we did not have access to interpreter services during focus groups/interviews), had a child admitted to 1 of 3 services (hospital medicine, neurology, or neurosurgery), and could attend a focus group within 30 days of the child’s discharge. The majority of participants had a child admitted to hospital medicine; however, caregivers with a generally healthy child admitted to either neurology or neurosurgery were eligible to participate in the study.

Study Design

As presented elsewhere,^17,20 we used focus groups and individual in-depth interviews to generate consensus themes about patient and caregiver experiences during the transition from hospital to home. Because there is evidence suggesting that focus group participants are more willing to talk openly when among others of similar backgrounds, we stratified the sample by the family’s estimated socioeconomic status.^21,22 Socioeconomic status was estimated by identifying the poverty rate in the census tract in which each participant lived. Census tracts, relatively homogeneous areas of ~4000 individuals, have been previously shown to effectively detect socioeconomic gradients.^23-26 Here, we separated participants into 2 socioeconomically distinct groupings (those in census tracts where <15% or ≥15% of the population lived below the federal poverty level).²⁶ This cut point ensured an equivalent number of eligible participants within each stratum and diversity within our sample.

Data Collection

Caregivers were recruited on the inpatient unit during their child’s hospitalization. Participants then returned to CCHMC facilities for the focus group within 30 days of discharge. Though efforts were made to enhance participation by scheduling sessions at multiple sites and during various days and times of the week, 4 sessions yielded just 1 participant; thus, the format for those became an individual interview. Childcare was provided, and participants received a gift card for their participation.

An open-ended, semistructured question guide,¹⁷ developed de novo by the research team, directed the discussion for focus groups and interviews. As data collection progressed, the question guide was adapted to incorporate new issues raised by participants. Questions broadly focused on aspects of the inpatient experience, discharge processes, and healthcare system and family factors thought to be most relevant to patient- and family-centered outcomes. Communication-related questions addressed information shared with families from the medical team about discharge, diagnoses, instructions, and care plans. An experienced moderator and qualitative research methodologist (SNS) used probes to further elucidate responses and expand discussion by participants. Sessions were held in private conference rooms, lasted ~90 minutes, were audiotaped, and were transcribed verbatim. Identifiers were stripped and transcripts were reviewed for accuracy. After conducting 11 focus groups (generally composed of 5-10 participants) and 4 individual interviews, the research team determined that theoretical saturation²⁷ was achieved, and recruitment was suspended.

Data Analysis

An inductive, thematic approach was used for analysis.²⁷ Transcripts were independently reviewed by a multidisciplinary team of 4 researchers, including 2 pediatricians (LGS and AFB), a clinical research coordinator (SAS), and a qualitative research methodologist (SNS). The study team identified emerging concepts and themes related to the transition from hospital to home; themes related to communication during hospitalization are presented here.

During the first phase of analysis, investigators independently read transcripts and later convened to identify and define initial concepts and themes. A preliminary codebook was then designed. Investigators continued to review and code transcripts independently, meeting regularly to discuss coding decisions collaboratively, resolving differences through consensus.²⁸ As patterns in the data became apparent, the codebook was modified iteratively, adding, subtracting, and refining codes as needed and grouping related codes. Results were reviewed with key stakeholders, including parents, inpatient and outpatient pediatricians, and home health nurses, throughout the analytic process.^27,28 Coded data were maintained in an electronic database accessible only to study personnel.

Participants

Resulting Themes

Analyses revealed the following 3 major communication-related themes with associated subthemes: (1) experiences that affect caregiver perceptions of communication between the inpatient medical team and families, (2) communication challenges for caregivers related to a teaching hospital environment, and (3) caregiver perceptions of communication between medical providers. Each theme (and subtheme) is explored below with accompanying verbatim quotes in the narrative and the tables.

Major Theme 1: Experiences that Affect Caregiver Perceptions of Communication Between the Inpatient Medical Team and Families

In contrast, some of the negative experiences shared by participants related to feeling excluded from discussions about their child’s care. One participant said, “They tell you…as much as they want to tell you. They don’t fully inform you on things.” Additionally, concerns were voiced about insufficient time for face-to-face discussions with physicians: “I forget what I have to say and it’s something really, really important…But now, my doctor is going, you can’t get the doctor back.” Finally, participants discussed how the use of medical jargon often made it more difficult to understand things, especially for those not in the medical field.

Major Theme 2: Communication Challenges for Caregivers Related to a Teaching Hospital Environment

Major Theme 3: Caregiver Perceptions of Communication Between Medical Providers

Perceptions were not isolated to the inpatient setting. Based on their experiences, caregivers similarly described their sense of how inpatient and outpatient providers were communicating with each other. In some cases, it was clear that good communication, as perceived by the participant, had occurred in situations in which the primary care physician knew “everything” about the hospitalization when they saw the patient in follow-up. One participant described, “We didn’t even realize at the time, [the medical team] had actually called our doctor and filled them in on our situation, and we got [to the follow up visit]…He already knew the entire situation.” There were others, however, who shared their uncertainty about whether the information exchange about their child’s hospitalization had actually occurred. They, therefore, voiced apprehension around who to call for advice after discharge; would their outpatient provider have their child’s hospitalization history and be able to properly advise them?

Communication during a hospitalization and at transition from hospital to home happens in both formal and informal ways; it is a vital component of appropriate, effective patient care. When done poorly, it has the potential to negatively affect a patient’s safety, care, and key outcomes.² During a hospitalization, the multifaceted nature of communication and multidisciplinary approach to care provision can create communication challenges and make fixing challenges difficult. In order to more comprehensively move toward mitigation, it is important to gather perspectives of key stakeholders, such as caregivers. Caregivers are an integral part of their child’s care during the hospitalization and particularly at home during their child’s recovery. They are also a valued member of the team, particularly in this era of family-centered care.^19,29 The perspectives of the caregivers presented here identified both successes and challenges of their communication experiences with the medical team during their child’s hospitalization. These perspectives included experiences affecting perceptions of communication between the inpatient medical team and families; communication related to the teaching hospital environment, including confusing messages associated with large multidisciplinary teams, aspects of FCR, and confusion about medical team member roles; and caregivers’ perceptions of communication between providers in and out of the hospital, including types of communication caregivers observed or believed occurred between medical providers. We believe that these qualitative results are crucial to developing better, more targeted interventions to improve communication.

Maintaining a healthy and productive relationship with patients and their caregivers is critical to providing comprehensive and safe patient care. As supported in the literature, we found that when caregivers were included in conversations, they felt appreciated and valued; in addition, when answers were not directly shared by providers or there were lingering questions, nurses often served as “interpreters.”^29,30 Indeed, nurses were seen as a critical touchpoint for many participants, individuals that could not only answer questions but also be a trusted source of information. Supporting such a relationship, and helping enhance the relationship between the family and other team members, may be particularly important considering the degree to which a hospitalization can stress a patient, caregiver, and family.^31-34 Developing rapport with families and facilitating relationships with the inclusion of nursing during FCR can be particularly helpful. Though this can be challenging with the many competing priorities of medical providers and the fast-paced, acute nature of inpatient care, making an effort to include nursing staff on rounds can cut down on confusion and assist the family in understanding care plans. This, in turn, can minimize the stress associated with hospitalization and improve the patient and family experience.

While academic institutions’ resources and access to subspecialties are often thought to be advantageous, there are other challenges inherent to providing care in such complex environments. Some caregivers cited confusion related to large teams of providers with, to them, indistinguishable roles asking redundant questions. These experiences affected their perceptions of FCR, generally leading to a fixation on its overwhelming aspects. Certain caregivers highlighted that FCR caused them, and their child, to feel overwhelmed and more confused about the plan for the day. It is important to find ways to mitigate these feelings while simultaneously continuing to support the inclusion of caregivers during their child’s hospitalization and understanding of care plans. Some initiatives (in addition to including nursing on FCR as discussed above) focus on improving the ways in which providers communicate with families during rounds and throughout the day, seeking to decrease miscommunications and medical errors while also striving for better quality of care and patient/family satisfaction.³⁵ Other initiatives seek to clarify identities and roles of the often large and confusing medical team. One such example of this is the development of a face sheet tool, which provides families with medical team members’ photos and role descriptions. Unaka et al.³⁶ found that the use of the face sheet tool improved the ability of caregivers to correctly identify providers and their roles. Thinking beyond interventions at the bedside, it is also important to include caregivers on higher level committees within the institution, such as on family advisory boards and/or peer support groups, to inform systems-wide interventions that support the tenants of family-centered care.²⁹ Efforts such as these are worth trialing in order to improve the patient and family experience and quality of communication.

Multiple studies have evaluated the challenges with ensuring consistent and useful handoffs across the inpatient-to-outpatient transition,^8-10,12 but few have looked at it from the perspective of the caregiver.¹³ After leaving the hospital to care for their recovering child, caregivers often feel overwhelmed; they may want, or need, to rely on the support of others in the outpatient environment. This support can be enhanced when outpatient providers are intimately aware of what occurred during the hospitalization; trust erodes if this is not the case. Given the value caregivers place on this communication occurring and occurring well, interventions supporting this communication are critical. Furthermore, as providers, we should also inform families that communication with outpatient providers is happening. Examples of efforts that have worked to improve the quality and consistency of communication with outpatient providers include improving discharge summary documentation, ensuring timely faxing of documentation to outpatient providers, and reliably making phone calls to outpatient providers.^37-39 These types of interventions seek to bridge the gap between inpatient and outpatient care and facilitate a smooth transfer of information in order to provide optimal quality of care and avoid undesired outcomes (eg, emergency department revisits, readmissions, medication errors, etc) and can be adopted by institutions to address the issue of communication between inpatient and outpatient providers.

We acknowledge limitations to our study. This was done at a single academic institution with only English-speaking participants. Thus, our results may not be reflective of caregivers of children cared for in different, more ethnically or linguistically diverse settings. The patient population at CCHMC, however, is diverse both demographically and clinically, which was reflected in the composition of our focus groups and interviews. Additionally, the inclusion of participants who received a nurse home visit after discharge may limit generalizability. However, only 4 participants had a nurse home visit; thus, the overwhelming majority of participants did not receive such an intervention. We also acknowledge that those willing to participate may have differed from nonparticipants, specifically sharing more positive experiences. We believe that our sampling strategy and use of an unbiased, nonhospital affiliated moderator minimized this possibility. Recall bias is possible, as participants were asked to reflect back on a discharge experience occurring in their past. We attempted to minimize this by holding sessions no more than 30 days from the day of discharge. Finally, we present data on caregivers’ perception of communication and not directly observed communication occurrences. Still, we expect that perception is powerful in and of itself, relevant to both outcomes and to interventions.

Communication during hospitalization influences how caregivers understand diagnoses and care plans. Communication perceived as effective fosters mutual understandings and positive relationships with the potential to result in better care and improved outcomes. Communication perceived as ineffective negatively affects experiences of patients and their caregivers and can adversely affect patient outcomes. Learning from caregivers’ experiences with communication during their child’s hospitalization can help identify modifiable factors and inform strategies to improve communication, support families through hospitalization, and facilitate a smooth reentry home.

This manuscript is submitted on behalf of the H2O study group: Katherine A. Auger, MD, MSc, JoAnne Bachus, BSN, Monica L. Borell, BSN, Lenisa V. Chang, MA, PhD, Jennifer M. Gold, BSN, Judy A. Heilman, RN, Joseph A. Jabour, BS, Jane C. Khoury, PhD, Margo J. Moore, BSN, CCRP, Rita H. Pickler, PNP, PhD, Anita N. Shah, DO, Angela M. Statile, MD, MEd, Heidi J. Sucharew, PhD, Karen P. Sullivan, BSN, Heather L. Tubbs-Cooley, RN, PhD, Susan Wade-Murphy, MSN, and Christine M. White, MD, MAT.

Disclaimer

All statements in this report, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors, or Methodology Committee.

Disclosure

 This work was (partially) supported through a Patient-Centered Outcomes Research Institute (PCORI) Award (HIS-1306-0081). The authors have no financial relationships relevant to this article to disclose. The authors have no conflicts of interest to disclose.

Provision of high-quality, high-value medical care hinges upon effective communication. During a hospitalization, critical information is communicated between patients, caregivers, and providers multiple times each day. This can cause inconsistent and misinterpreted messages, leaving ample room for error.¹ The Joint Commission notes that communication failures occurring between medical providers account for ~60% of all sentinel or serious adverse events that result in death or harm to a patient.² Communication that occurs between patients and/or their caregivers and medical providers is also critically important. The content and consistency of this communication is highly valued by patients and providers and can affect patient outcomes during hospitalizations and during transitions to home.^3,4 Still, the multifactorial, complex nature of communication in the pediatric inpatient setting is not well understood.^5,6

During hospitalization, communication happens continuously during both daytime and nighttime hours. It also precedes the particularly fragile period of transition from hospital to home. Studies have shown that nighttime communication between caregivers and medical providers (ie, nurses and physicians), as well as caregivers’ perceptions of interactions that occur between nurses and physicians, may be closely linked to that caregiver’s satisfaction and perceived quality of care.^6,7 Communication that occurs between inpatient and outpatient providers is also subject to barriers (eg, limited availability for direct communication)^8-12; studies have shown that patient and/or caregiver satisfaction has also been tied to perceptions of this communication.^13,14 Moreover, a caregiver’s ability to understand diagnoses and adhere to postdischarge care plans is intimately tied to communication during the hospitalization and at discharge. Although many improvement efforts have aimed to enhance communication during these vulnerable time periods,^3,15,16 there remains much work to be done.^1,10,12

The many facets and routes of communication, and the multiple stakeholders involved, make improvement efforts challenging. We believe that more effective communication strategies could result from a deeper understanding of how caregivers view communication successes and challenges during a hospitalization. We see this as key to developing meaningful interventions that are directed towards improving communication and, by extension, patient satisfaction and safety. Here, we sought to extend findings from a broader qualitative study¹⁷ by developing an in-depth understanding of communication issues experienced by families during their child’s hospitalization and during the transition to home.

Setting

The analyses presented here emerged from the Hospital to Home Outcomes Study (H2O). The first objective of H2O was to explore the caregiver perspective on hospital-to-home transitions. Here, we present the results related to caregiver perspectives of communication, while broader results of our qualitative investigation have been published elsewhere.¹⁷ This objective informed the latter 2 aims of the H2O study, which were to modify an existing nurse-led transitional home visit (THV) program and to study the effectiveness of the modified THV on reutilization and patient-specific outcomes via a randomized control trial. The specifics of the H2O protocol and design have been presented elsewhere.¹⁸

H2O was approved by the Institutional Review Board at Cincinnati Children’s Hospital Medical Center (CCHMC), a free-standing, academic children’s hospital with ~600 inpatient beds. This teaching hospital has >800 total medical students, residents, and fellows. Approximately 8000 children are hospitalized annually at CCHMC for general pediatric conditions, with ~85% of such admissions staffed by hospitalists from the Division of Hospital Medicine. The division is composed of >40 providers who devote the majority of their clinical time to the hospital medicine service; 15 additional providers work on the hospital medicine service but have primary clinical responsibilities in another division.

Family-centered rounds (FCR) are the standard of care at CCHMC, involving family members at the bedside to discuss patient care plans and diagnoses with the medical team.¹⁹ On a typical day, a team conducting FCR is composed of 1 attending, 1 fellow, 2 to 3 pediatric residents, 2 to 3 medical students, a charge nurse or bedside nurse, and a pharmacist. Other ancillary staff, such as social workers, care coordinators, nurse practitioners, or dieticians, may also participate on rounds, particularly for children with greater medical complexity.

Population

Caregivers of children discharged with acute medical conditions were eligible for recruitment if they were English-speaking (we did not have access to interpreter services during focus groups/interviews), had a child admitted to 1 of 3 services (hospital medicine, neurology, or neurosurgery), and could attend a focus group within 30 days of the child’s discharge. The majority of participants had a child admitted to hospital medicine; however, caregivers with a generally healthy child admitted to either neurology or neurosurgery were eligible to participate in the study.

Study Design

As presented elsewhere,^17,20 we used focus groups and individual in-depth interviews to generate consensus themes about patient and caregiver experiences during the transition from hospital to home. Because there is evidence suggesting that focus group participants are more willing to talk openly when among others of similar backgrounds, we stratified the sample by the family’s estimated socioeconomic status.^21,22 Socioeconomic status was estimated by identifying the poverty rate in the census tract in which each participant lived. Census tracts, relatively homogeneous areas of ~4000 individuals, have been previously shown to effectively detect socioeconomic gradients.^23-26 Here, we separated participants into 2 socioeconomically distinct groupings (those in census tracts where <15% or ≥15% of the population lived below the federal poverty level).²⁶ This cut point ensured an equivalent number of eligible participants within each stratum and diversity within our sample.

Data Collection

Caregivers were recruited on the inpatient unit during their child’s hospitalization. Participants then returned to CCHMC facilities for the focus group within 30 days of discharge. Though efforts were made to enhance participation by scheduling sessions at multiple sites and during various days and times of the week, 4 sessions yielded just 1 participant; thus, the format for those became an individual interview. Childcare was provided, and participants received a gift card for their participation.

An open-ended, semistructured question guide,¹⁷ developed de novo by the research team, directed the discussion for focus groups and interviews. As data collection progressed, the question guide was adapted to incorporate new issues raised by participants. Questions broadly focused on aspects of the inpatient experience, discharge processes, and healthcare system and family factors thought to be most relevant to patient- and family-centered outcomes. Communication-related questions addressed information shared with families from the medical team about discharge, diagnoses, instructions, and care plans. An experienced moderator and qualitative research methodologist (SNS) used probes to further elucidate responses and expand discussion by participants. Sessions were held in private conference rooms, lasted ~90 minutes, were audiotaped, and were transcribed verbatim. Identifiers were stripped and transcripts were reviewed for accuracy. After conducting 11 focus groups (generally composed of 5-10 participants) and 4 individual interviews, the research team determined that theoretical saturation²⁷ was achieved, and recruitment was suspended.

Data Analysis

An inductive, thematic approach was used for analysis.²⁷ Transcripts were independently reviewed by a multidisciplinary team of 4 researchers, including 2 pediatricians (LGS and AFB), a clinical research coordinator (SAS), and a qualitative research methodologist (SNS). The study team identified emerging concepts and themes related to the transition from hospital to home; themes related to communication during hospitalization are presented here.

During the first phase of analysis, investigators independently read transcripts and later convened to identify and define initial concepts and themes. A preliminary codebook was then designed. Investigators continued to review and code transcripts independently, meeting regularly to discuss coding decisions collaboratively, resolving differences through consensus.²⁸ As patterns in the data became apparent, the codebook was modified iteratively, adding, subtracting, and refining codes as needed and grouping related codes. Results were reviewed with key stakeholders, including parents, inpatient and outpatient pediatricians, and home health nurses, throughout the analytic process.^27,28 Coded data were maintained in an electronic database accessible only to study personnel.

Participants

Resulting Themes

Analyses revealed the following 3 major communication-related themes with associated subthemes: (1) experiences that affect caregiver perceptions of communication between the inpatient medical team and families, (2) communication challenges for caregivers related to a teaching hospital environment, and (3) caregiver perceptions of communication between medical providers. Each theme (and subtheme) is explored below with accompanying verbatim quotes in the narrative and the tables.

Major Theme 1: Experiences that Affect Caregiver Perceptions of Communication Between the Inpatient Medical Team and Families

In contrast, some of the negative experiences shared by participants related to feeling excluded from discussions about their child’s care. One participant said, “They tell you…as much as they want to tell you. They don’t fully inform you on things.” Additionally, concerns were voiced about insufficient time for face-to-face discussions with physicians: “I forget what I have to say and it’s something really, really important…But now, my doctor is going, you can’t get the doctor back.” Finally, participants discussed how the use of medical jargon often made it more difficult to understand things, especially for those not in the medical field.

Major Theme 2: Communication Challenges for Caregivers Related to a Teaching Hospital Environment

Major Theme 3: Caregiver Perceptions of Communication Between Medical Providers

Perceptions were not isolated to the inpatient setting. Based on their experiences, caregivers similarly described their sense of how inpatient and outpatient providers were communicating with each other. In some cases, it was clear that good communication, as perceived by the participant, had occurred in situations in which the primary care physician knew “everything” about the hospitalization when they saw the patient in follow-up. One participant described, “We didn’t even realize at the time, [the medical team] had actually called our doctor and filled them in on our situation, and we got [to the follow up visit]…He already knew the entire situation.” There were others, however, who shared their uncertainty about whether the information exchange about their child’s hospitalization had actually occurred. They, therefore, voiced apprehension around who to call for advice after discharge; would their outpatient provider have their child’s hospitalization history and be able to properly advise them?

Communication during a hospitalization and at transition from hospital to home happens in both formal and informal ways; it is a vital component of appropriate, effective patient care. When done poorly, it has the potential to negatively affect a patient’s safety, care, and key outcomes.² During a hospitalization, the multifaceted nature of communication and multidisciplinary approach to care provision can create communication challenges and make fixing challenges difficult. In order to more comprehensively move toward mitigation, it is important to gather perspectives of key stakeholders, such as caregivers. Caregivers are an integral part of their child’s care during the hospitalization and particularly at home during their child’s recovery. They are also a valued member of the team, particularly in this era of family-centered care.^19,29 The perspectives of the caregivers presented here identified both successes and challenges of their communication experiences with the medical team during their child’s hospitalization. These perspectives included experiences affecting perceptions of communication between the inpatient medical team and families; communication related to the teaching hospital environment, including confusing messages associated with large multidisciplinary teams, aspects of FCR, and confusion about medical team member roles; and caregivers’ perceptions of communication between providers in and out of the hospital, including types of communication caregivers observed or believed occurred between medical providers. We believe that these qualitative results are crucial to developing better, more targeted interventions to improve communication.

Maintaining a healthy and productive relationship with patients and their caregivers is critical to providing comprehensive and safe patient care. As supported in the literature, we found that when caregivers were included in conversations, they felt appreciated and valued; in addition, when answers were not directly shared by providers or there were lingering questions, nurses often served as “interpreters.”^29,30 Indeed, nurses were seen as a critical touchpoint for many participants, individuals that could not only answer questions but also be a trusted source of information. Supporting such a relationship, and helping enhance the relationship between the family and other team members, may be particularly important considering the degree to which a hospitalization can stress a patient, caregiver, and family.^31-34 Developing rapport with families and facilitating relationships with the inclusion of nursing during FCR can be particularly helpful. Though this can be challenging with the many competing priorities of medical providers and the fast-paced, acute nature of inpatient care, making an effort to include nursing staff on rounds can cut down on confusion and assist the family in understanding care plans. This, in turn, can minimize the stress associated with hospitalization and improve the patient and family experience.

While academic institutions’ resources and access to subspecialties are often thought to be advantageous, there are other challenges inherent to providing care in such complex environments. Some caregivers cited confusion related to large teams of providers with, to them, indistinguishable roles asking redundant questions. These experiences affected their perceptions of FCR, generally leading to a fixation on its overwhelming aspects. Certain caregivers highlighted that FCR caused them, and their child, to feel overwhelmed and more confused about the plan for the day. It is important to find ways to mitigate these feelings while simultaneously continuing to support the inclusion of caregivers during their child’s hospitalization and understanding of care plans. Some initiatives (in addition to including nursing on FCR as discussed above) focus on improving the ways in which providers communicate with families during rounds and throughout the day, seeking to decrease miscommunications and medical errors while also striving for better quality of care and patient/family satisfaction.³⁵ Other initiatives seek to clarify identities and roles of the often large and confusing medical team. One such example of this is the development of a face sheet tool, which provides families with medical team members’ photos and role descriptions. Unaka et al.³⁶ found that the use of the face sheet tool improved the ability of caregivers to correctly identify providers and their roles. Thinking beyond interventions at the bedside, it is also important to include caregivers on higher level committees within the institution, such as on family advisory boards and/or peer support groups, to inform systems-wide interventions that support the tenants of family-centered care.²⁹ Efforts such as these are worth trialing in order to improve the patient and family experience and quality of communication.

Multiple studies have evaluated the challenges with ensuring consistent and useful handoffs across the inpatient-to-outpatient transition,^8-10,12 but few have looked at it from the perspective of the caregiver.¹³ After leaving the hospital to care for their recovering child, caregivers often feel overwhelmed; they may want, or need, to rely on the support of others in the outpatient environment. This support can be enhanced when outpatient providers are intimately aware of what occurred during the hospitalization; trust erodes if this is not the case. Given the value caregivers place on this communication occurring and occurring well, interventions supporting this communication are critical. Furthermore, as providers, we should also inform families that communication with outpatient providers is happening. Examples of efforts that have worked to improve the quality and consistency of communication with outpatient providers include improving discharge summary documentation, ensuring timely faxing of documentation to outpatient providers, and reliably making phone calls to outpatient providers.^37-39 These types of interventions seek to bridge the gap between inpatient and outpatient care and facilitate a smooth transfer of information in order to provide optimal quality of care and avoid undesired outcomes (eg, emergency department revisits, readmissions, medication errors, etc) and can be adopted by institutions to address the issue of communication between inpatient and outpatient providers.

We acknowledge limitations to our study. This was done at a single academic institution with only English-speaking participants. Thus, our results may not be reflective of caregivers of children cared for in different, more ethnically or linguistically diverse settings. The patient population at CCHMC, however, is diverse both demographically and clinically, which was reflected in the composition of our focus groups and interviews. Additionally, the inclusion of participants who received a nurse home visit after discharge may limit generalizability. However, only 4 participants had a nurse home visit; thus, the overwhelming majority of participants did not receive such an intervention. We also acknowledge that those willing to participate may have differed from nonparticipants, specifically sharing more positive experiences. We believe that our sampling strategy and use of an unbiased, nonhospital affiliated moderator minimized this possibility. Recall bias is possible, as participants were asked to reflect back on a discharge experience occurring in their past. We attempted to minimize this by holding sessions no more than 30 days from the day of discharge. Finally, we present data on caregivers’ perception of communication and not directly observed communication occurrences. Still, we expect that perception is powerful in and of itself, relevant to both outcomes and to interventions.

Communication during hospitalization influences how caregivers understand diagnoses and care plans. Communication perceived as effective fosters mutual understandings and positive relationships with the potential to result in better care and improved outcomes. Communication perceived as ineffective negatively affects experiences of patients and their caregivers and can adversely affect patient outcomes. Learning from caregivers’ experiences with communication during their child’s hospitalization can help identify modifiable factors and inform strategies to improve communication, support families through hospitalization, and facilitate a smooth reentry home.

This manuscript is submitted on behalf of the H2O study group: Katherine A. Auger, MD, MSc, JoAnne Bachus, BSN, Monica L. Borell, BSN, Lenisa V. Chang, MA, PhD, Jennifer M. Gold, BSN, Judy A. Heilman, RN, Joseph A. Jabour, BS, Jane C. Khoury, PhD, Margo J. Moore, BSN, CCRP, Rita H. Pickler, PNP, PhD, Anita N. Shah, DO, Angela M. Statile, MD, MEd, Heidi J. Sucharew, PhD, Karen P. Sullivan, BSN, Heather L. Tubbs-Cooley, RN, PhD, Susan Wade-Murphy, MSN, and Christine M. White, MD, MAT.

Disclaimer

All statements in this report, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors, or Methodology Committee.

Disclosure

 This work was (partially) supported through a Patient-Centered Outcomes Research Institute (PCORI) Award (HIS-1306-0081). The authors have no financial relationships relevant to this article to disclose. The authors have no conflicts of interest to disclose.

Acne fulminans is an uncommon and debilitating disease that presents as an acute eruption of nodular and ulcerative acne lesions with associated systemic symptoms.^1,2 Although its underlying pathophysiology is not well understood, it occurs commonly during treatment of severe acne (eg, acne conglobata) with isotretinoin in young adolescent males.³ Zaba et al⁴ indicated that an underlying genetic disorder, increase in serum androgen levels, or presence of autoimmune disorders may contribute to the development of acne fulminans.

Isotretinoin and doxycycline also can potentially induce development of neutrophilic dermatoses including Sweet syndrome and pyoderma gangrenosum in patients with severe acne lesions, which can be clinically similar to an acne fulminans eruption. The neutrophilic dermatosis is characterized by the acute appearance of painful ulcerative papulonodules accompanied by systemic symptoms including fever and leukocytosis.

Case Report

A 13-year-old adolescent boy was initially assessed by his family physician 2 months prior and started on oral doxycycline 100 mg twice daily for acne conglobata on the back. Unfortunately, the acne lesions, especially those on the upper back (Figure 1), started getting worse after 1 month of treatment with doxycycline; thus, he subsequently was switched to oral isotretinoin 0.5 mg/kg once daily. Less than 2 weeks later, the acne lesions worsened, and the patient also developed severe generalized arthralgia, myalgia, and fever (>38.3°C). He acutely developed hundreds of ulcerative plaques covering the entire trunk, upper extremities, face, and neck.

Photography courtesy of the Strollery Children&#039;s Hospital (Edmonton, Alberta, Canada) professional photography team.

He was admitted to the Stollery Children’s Hospital (Edmonton, Alberta, Canada) and was assessed by the dermatology, rheumatology, and general pediatric teams (Figure 2). He initially was investigated for the potential presence of autoinflammatory disorders, such as PAPA syndrome (pyogenic arthritis, pyoderma gangrenosum, acne) and SAPHO syndrome (synovitis, acne, pustulosis, hyperostosis, osteitis). A laboratory workup showed an elevated erythrocyte sedimentation rate (43 mm/h [reference range, <20 mm/h]) and C-reactive protein level (50 mg/L [reference range, <10 mg/L]), leukocytosis (14×10⁹/L [reference range, 4.5–11.0×10⁹/L]), and transaminitis (alanine aminotransferase, 72 U/L [reference range, 10–40 U/L]). A radiograph of the clavicle did not reveal any osteitis. Rheumatology assessment ruled out the presence of any synovitis. Based on the patient’s history and physical presentation, a differential diagnosis of acne fulminans, pyoderma gangrenosum, and Sweet syndrome was entertained. Histologic findings were consistent with a diagnosis of ulcerative neutrophilic dermatosis. The patient required prolonged hospitalization (>3 months) for treatment, dressing changes, and pain control.

Photography courtesy of the Strollery Children&#039;s Hospital (Edmonton, Alberta, Canada) professional photography team.

The patient initially was treated with prednisone 30 mg once daily for 3 weeks; dapsone 50 mg once daily and colchicine 0.6 mg twice daily were added while attempting to slowly wean off the prednisone (starting at 30 mg daily and reducing by 5 mg every other week). An attempt to discontinue the prednisone after 2 months was followed by immediate recurrence of the lesions (Figure 3), and the prednisone was restarted for another month. He was subsequently switched to oral cyclosporine 5 mg/kg once daily and achieved considerable improvement in his skin condition (Figure 4).

Photography courtesy of the Strollery Children&#039;s Hospital (Edmonton, Alberta, Canada) professional photography team.

Photography courtesy of the Strollery Children&#039;s Hospital (Edmonton, Alberta, Canada) professional photography team.

Comment

Thomson and Cunliffe⁵ reported a small case series of 11 young male patients with a mean age of 17 years who presented with severe worsening of their acne eruptions after taking isotretinoin, and they all responded well to an oral steroid. In another study, Bottomley and Cunliffe⁶ indicated that young male patients with notable acne on the trunk who are receiving a minimum dose of 0.5 mg/kg once daily of isotretinoin are at considerable risk for severe worsening of their skin condition.

Although severe worsening of acne lesions leading to acne fulminans or neutrophilic dermatosis secondary to isotretinoin or even doxycycline use is a rare entity, precautionary steps should be taken prior to treating acne conglobata patients with these agents. A review of PubMed articles indexed for MEDLINE using the terms acne, acne conglobata, and doxycycline revealed 2 prior cases of worsening acne in patients treated with doxycycline.^7,8 Therefore, any patient presenting with acute worsening of an acne eruption while being treated with isotretinoin or doxycycline needs to be assessed for potential diagnosis of drug-induced acne fulminans or neutrophilic dermatosis.

It has been clearly documented in the literature that both doxycycline and isotretinoin can induce or exacerbate neutrophilic dermatoses in patients with severe underlying acne.^6-8 The presentation may be mistaken for worsening acne, leading to inappropriate initiation or increase in the dose of isotretinoin therapy and worsening of the disease with potentially devastating disfiguring consequences. These patients tend to respond well to high-dose oral steroids alone or in combination with dapsone. A slow steroid taper over several months is recommended due to a high tendency for recurrence.

Acne fulminans is an uncommon and debilitating disease that presents as an acute eruption of nodular and ulcerative acne lesions with associated systemic symptoms.^1,2 Although its underlying pathophysiology is not well understood, it occurs commonly during treatment of severe acne (eg, acne conglobata) with isotretinoin in young adolescent males.³ Zaba et al⁴ indicated that an underlying genetic disorder, increase in serum androgen levels, or presence of autoimmune disorders may contribute to the development of acne fulminans.

Isotretinoin and doxycycline also can potentially induce development of neutrophilic dermatoses including Sweet syndrome and pyoderma gangrenosum in patients with severe acne lesions, which can be clinically similar to an acne fulminans eruption. The neutrophilic dermatosis is characterized by the acute appearance of painful ulcerative papulonodules accompanied by systemic symptoms including fever and leukocytosis.

Case Report

A 13-year-old adolescent boy was initially assessed by his family physician 2 months prior and started on oral doxycycline 100 mg twice daily for acne conglobata on the back. Unfortunately, the acne lesions, especially those on the upper back (Figure 1), started getting worse after 1 month of treatment with doxycycline; thus, he subsequently was switched to oral isotretinoin 0.5 mg/kg once daily. Less than 2 weeks later, the acne lesions worsened, and the patient also developed severe generalized arthralgia, myalgia, and fever (>38.3°C). He acutely developed hundreds of ulcerative plaques covering the entire trunk, upper extremities, face, and neck.

Photography courtesy of the Strollery Children&#039;s Hospital (Edmonton, Alberta, Canada) professional photography team.

He was admitted to the Stollery Children’s Hospital (Edmonton, Alberta, Canada) and was assessed by the dermatology, rheumatology, and general pediatric teams (Figure 2). He initially was investigated for the potential presence of autoinflammatory disorders, such as PAPA syndrome (pyogenic arthritis, pyoderma gangrenosum, acne) and SAPHO syndrome (synovitis, acne, pustulosis, hyperostosis, osteitis). A laboratory workup showed an elevated erythrocyte sedimentation rate (43 mm/h [reference range, <20 mm/h]) and C-reactive protein level (50 mg/L [reference range, <10 mg/L]), leukocytosis (14×10⁹/L [reference range, 4.5–11.0×10⁹/L]), and transaminitis (alanine aminotransferase, 72 U/L [reference range, 10–40 U/L]). A radiograph of the clavicle did not reveal any osteitis. Rheumatology assessment ruled out the presence of any synovitis. Based on the patient’s history and physical presentation, a differential diagnosis of acne fulminans, pyoderma gangrenosum, and Sweet syndrome was entertained. Histologic findings were consistent with a diagnosis of ulcerative neutrophilic dermatosis. The patient required prolonged hospitalization (>3 months) for treatment, dressing changes, and pain control.

Photography courtesy of the Strollery Children&#039;s Hospital (Edmonton, Alberta, Canada) professional photography team.

The patient initially was treated with prednisone 30 mg once daily for 3 weeks; dapsone 50 mg once daily and colchicine 0.6 mg twice daily were added while attempting to slowly wean off the prednisone (starting at 30 mg daily and reducing by 5 mg every other week). An attempt to discontinue the prednisone after 2 months was followed by immediate recurrence of the lesions (Figure 3), and the prednisone was restarted for another month. He was subsequently switched to oral cyclosporine 5 mg/kg once daily and achieved considerable improvement in his skin condition (Figure 4).

Photography courtesy of the Strollery Children&#039;s Hospital (Edmonton, Alberta, Canada) professional photography team.

Photography courtesy of the Strollery Children&#039;s Hospital (Edmonton, Alberta, Canada) professional photography team.

Comment

Thomson and Cunliffe⁵ reported a small case series of 11 young male patients with a mean age of 17 years who presented with severe worsening of their acne eruptions after taking isotretinoin, and they all responded well to an oral steroid. In another study, Bottomley and Cunliffe⁶ indicated that young male patients with notable acne on the trunk who are receiving a minimum dose of 0.5 mg/kg once daily of isotretinoin are at considerable risk for severe worsening of their skin condition.

Although severe worsening of acne lesions leading to acne fulminans or neutrophilic dermatosis secondary to isotretinoin or even doxycycline use is a rare entity, precautionary steps should be taken prior to treating acne conglobata patients with these agents. A review of PubMed articles indexed for MEDLINE using the terms acne, acne conglobata, and doxycycline revealed 2 prior cases of worsening acne in patients treated with doxycycline.^7,8 Therefore, any patient presenting with acute worsening of an acne eruption while being treated with isotretinoin or doxycycline needs to be assessed for potential diagnosis of drug-induced acne fulminans or neutrophilic dermatosis.

It has been clearly documented in the literature that both doxycycline and isotretinoin can induce or exacerbate neutrophilic dermatoses in patients with severe underlying acne.^6-8 The presentation may be mistaken for worsening acne, leading to inappropriate initiation or increase in the dose of isotretinoin therapy and worsening of the disease with potentially devastating disfiguring consequences. These patients tend to respond well to high-dose oral steroids alone or in combination with dapsone. A slow steroid taper over several months is recommended due to a high tendency for recurrence.

Acne fulminans is an uncommon and debilitating disease that presents as an acute eruption of nodular and ulcerative acne lesions with associated systemic symptoms.^1,2 Although its underlying pathophysiology is not well understood, it occurs commonly during treatment of severe acne (eg, acne conglobata) with isotretinoin in young adolescent males.³ Zaba et al⁴ indicated that an underlying genetic disorder, increase in serum androgen levels, or presence of autoimmune disorders may contribute to the development of acne fulminans.

Isotretinoin and doxycycline also can potentially induce development of neutrophilic dermatoses including Sweet syndrome and pyoderma gangrenosum in patients with severe acne lesions, which can be clinically similar to an acne fulminans eruption. The neutrophilic dermatosis is characterized by the acute appearance of painful ulcerative papulonodules accompanied by systemic symptoms including fever and leukocytosis.

Case Report

A 13-year-old adolescent boy was initially assessed by his family physician 2 months prior and started on oral doxycycline 100 mg twice daily for acne conglobata on the back. Unfortunately, the acne lesions, especially those on the upper back (Figure 1), started getting worse after 1 month of treatment with doxycycline; thus, he subsequently was switched to oral isotretinoin 0.5 mg/kg once daily. Less than 2 weeks later, the acne lesions worsened, and the patient also developed severe generalized arthralgia, myalgia, and fever (>38.3°C). He acutely developed hundreds of ulcerative plaques covering the entire trunk, upper extremities, face, and neck.

Photography courtesy of the Strollery Children&#039;s Hospital (Edmonton, Alberta, Canada) professional photography team.

He was admitted to the Stollery Children’s Hospital (Edmonton, Alberta, Canada) and was assessed by the dermatology, rheumatology, and general pediatric teams (Figure 2). He initially was investigated for the potential presence of autoinflammatory disorders, such as PAPA syndrome (pyogenic arthritis, pyoderma gangrenosum, acne) and SAPHO syndrome (synovitis, acne, pustulosis, hyperostosis, osteitis). A laboratory workup showed an elevated erythrocyte sedimentation rate (43 mm/h [reference range, <20 mm/h]) and C-reactive protein level (50 mg/L [reference range, <10 mg/L]), leukocytosis (14×10⁹/L [reference range, 4.5–11.0×10⁹/L]), and transaminitis (alanine aminotransferase, 72 U/L [reference range, 10–40 U/L]). A radiograph of the clavicle did not reveal any osteitis. Rheumatology assessment ruled out the presence of any synovitis. Based on the patient’s history and physical presentation, a differential diagnosis of acne fulminans, pyoderma gangrenosum, and Sweet syndrome was entertained. Histologic findings were consistent with a diagnosis of ulcerative neutrophilic dermatosis. The patient required prolonged hospitalization (>3 months) for treatment, dressing changes, and pain control.

Photography courtesy of the Strollery Children&#039;s Hospital (Edmonton, Alberta, Canada) professional photography team.

The patient initially was treated with prednisone 30 mg once daily for 3 weeks; dapsone 50 mg once daily and colchicine 0.6 mg twice daily were added while attempting to slowly wean off the prednisone (starting at 30 mg daily and reducing by 5 mg every other week). An attempt to discontinue the prednisone after 2 months was followed by immediate recurrence of the lesions (Figure 3), and the prednisone was restarted for another month. He was subsequently switched to oral cyclosporine 5 mg/kg once daily and achieved considerable improvement in his skin condition (Figure 4).

Photography courtesy of the Strollery Children&#039;s Hospital (Edmonton, Alberta, Canada) professional photography team.

Photography courtesy of the Strollery Children&#039;s Hospital (Edmonton, Alberta, Canada) professional photography team.

Comment

Thomson and Cunliffe⁵ reported a small case series of 11 young male patients with a mean age of 17 years who presented with severe worsening of their acne eruptions after taking isotretinoin, and they all responded well to an oral steroid. In another study, Bottomley and Cunliffe⁶ indicated that young male patients with notable acne on the trunk who are receiving a minimum dose of 0.5 mg/kg once daily of isotretinoin are at considerable risk for severe worsening of their skin condition.

Although severe worsening of acne lesions leading to acne fulminans or neutrophilic dermatosis secondary to isotretinoin or even doxycycline use is a rare entity, precautionary steps should be taken prior to treating acne conglobata patients with these agents. A review of PubMed articles indexed for MEDLINE using the terms acne, acne conglobata, and doxycycline revealed 2 prior cases of worsening acne in patients treated with doxycycline.^7,8 Therefore, any patient presenting with acute worsening of an acne eruption while being treated with isotretinoin or doxycycline needs to be assessed for potential diagnosis of drug-induced acne fulminans or neutrophilic dermatosis.

It has been clearly documented in the literature that both doxycycline and isotretinoin can induce or exacerbate neutrophilic dermatoses in patients with severe underlying acne.^6-8 The presentation may be mistaken for worsening acne, leading to inappropriate initiation or increase in the dose of isotretinoin therapy and worsening of the disease with potentially devastating disfiguring consequences. These patients tend to respond well to high-dose oral steroids alone or in combination with dapsone. A slow steroid taper over several months is recommended due to a high tendency for recurrence.

LOS ANGELES – Current and previous night workers had significantly increased levels of hemoglobin A_1c, compared with diurnal workers, preliminary results from an ongoing study showed. The finding sheds further insight into the link between environmental light, circadian rhythms, and metabolic disorders.

“To date, observational studies on bright light have revealed that evening bright light is associated with increased appetite and that bedroom light intensity is correlated with obesity,” Massimo Federici, MD, said at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease. “It’s also been reported that artificial light is correlated with type 2 diabetes in the home setting and that daytime light exposure is positively correlated with body mass index. However, no studies have directly investigated the effect of acute light on human glucose metabolism.”

Doug Brunk/Frontline Medical News

[email protected]

LOS ANGELES – Current and previous night workers had significantly increased levels of hemoglobin A_1c, compared with diurnal workers, preliminary results from an ongoing study showed. The finding sheds further insight into the link between environmental light, circadian rhythms, and metabolic disorders.

“To date, observational studies on bright light have revealed that evening bright light is associated with increased appetite and that bedroom light intensity is correlated with obesity,” Massimo Federici, MD, said at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease. “It’s also been reported that artificial light is correlated with type 2 diabetes in the home setting and that daytime light exposure is positively correlated with body mass index. However, no studies have directly investigated the effect of acute light on human glucose metabolism.”

Doug Brunk/Frontline Medical News

[email protected]

LOS ANGELES – Current and previous night workers had significantly increased levels of hemoglobin A_1c, compared with diurnal workers, preliminary results from an ongoing study showed. The finding sheds further insight into the link between environmental light, circadian rhythms, and metabolic disorders.

“To date, observational studies on bright light have revealed that evening bright light is associated with increased appetite and that bedroom light intensity is correlated with obesity,” Massimo Federici, MD, said at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease. “It’s also been reported that artificial light is correlated with type 2 diabetes in the home setting and that daytime light exposure is positively correlated with body mass index. However, no studies have directly investigated the effect of acute light on human glucose metabolism.”

Doug Brunk/Frontline Medical News

[email protected]