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Malignant Otitis Externa
Malignant Otitis Externa (MOE) is a necrotizing infection of the external auditory canal characterized by extension into nearby soft tissue and bony structures that can potentially lead to mastoiditis, skull base osteomyelitis, cranial nerve palsies, and rarely, intracranial complications. MOE has been classically described as a disease affecting elderly diabetics1 and has been reported in immunocompromised patients with acquired immune deficiency syndrome (AIDS), malignancy, patients receiving chemotherapy, and neutropenic children.24 The incidence of MOE in the general population is estimated to be quite low and difficult to determine.5 However, over the past decades, the number of reported cases has been increasing, suggesting increased awareness of this syndrome by primary care physicians.6
Case Report
A 56‐year‐old white male was brought to the emergency department with altered mental status including decreased level of consciousness, bizarre behavior, headaches, and nausea for several weeks. He had a history of alcohol and cocaine abuse. He was homeless and a smoker. On examination, the patient was lethargic, disoriented with respect to time, place and person. Blood pressure was 107/72 mm Hg, heart rate 85 beats per minute; respirations were 16 per minute and temperature was 97.9F. Neurological examination was significant for loss of vision of the left eye and left facial peripheral nerve palsy. Examination of the left eye showed yellowish‐greenish discharge, a lower lid ectropium with upper lid ptosis, conjunctival erythema, and an 8 mm 6 mm abrasion in the medial half of the cornea. He had purulent drainage from the left ear with small vesicular lesions on the auricle, and a 3 cm 4 cm abscess on the right forearm. The remainder of the physical examination was unremarkable.
Laboratory‐test results showed white blood cell (WBC) count; 11.27 109 cells/L with 76.6% neutrophils. A complete metabolic panel was within normal limits. Human immunodeficiency virus (HIV) and RPR testing were negative. Cerebrospinal fluid (CSF) studies demonstrated a WBC 39 cells/mm3 with lymphocytes predominance (85%), Red blood cell (RBC) 6 cells/mm3, protein 48 mg/dL, and glucose; 63 mg/dL. Computed tomographic scan of the head revealed an area of low attenuation with surrounding edema of the left temporal lobe and fracture of the temporal bone on the superior margin of the mastoid air cells extending into the left mastoid air cells (Figure 1). The fluid draining from the patient's left ear grew 2 different strains of Pseudomonas aeruginosa. Magnetic resonance imaging (MRI) of the brain demonstrated a 2.5 cm to 3.0 cm region of multiple loculations and edema in the left temporal lobe representing cerebritis with abscess and complete opacification of left mastoid air cell suggestive of mastoiditis (Figure 2). Piperacillin/tazobactam and tobramycin were initiated for suspected MOE with brain involvement. CSF and blood cultures were negative.
A repeat MRI at 3 weeks of therapy demonstrated interval improvement in the temporal lobe abscess and the edema surrounding the infection. At the time of discharge, after 6 weeks of antimicrobial therapy, the patient was alert and oriented with respect to person, place, and time.
Discussion
Pseudomonas aeruginosa is the most common organism cultured from MOE.4, 5 Other organisms such as Staphylococcus aureus,6 Proteus mirabilis, Klebsiella oxytocea,7 and Aspergillus species8 have been reported as well.
While the exact pathogenesis of MOE is poorly understood, accidental trauma from cotton swabs, exposure to lake water, swimming pool water, and repeated aural lavage have all been implicated as inciting factors.9 The current literature suggests that Pseudomonal otitis externa occurs due to abnormal host defense mechanisms rather than enhanced pathogen colonization.10
MOE typically presents with severe otalgia, headache, auricular tenderness, mastoid tenderness, or persistent otorrhea. The pain of MOE is usually severe, and the classic signs of infection such as fever, leukocytosis and neutrophil predominance (left shift) may not be present.5 The diagnosis can be confirmed by otoscopic exam which will demonstrate granulation tissue at the junction between the bony and cartilaginous tissues in the external auditory canal. MOE can produce certain physical findings that should raise red flags for local extension. Temporomandibular joint pain in the susceptible patient with otalgia could indicate MOE with joint invasion. Cranial nerve involvement, most commonly involves the seventh cranial nerve which results in a facial palsy. Other cranial neuropathies have been reported in MOE such as the glossopharyngeal, vagal, spinal accessory, and hypoglossal nerves.11 Confusion and nuchal rigidity should arouse suspicion of intracranial extension of the infection.
The diagnosis of MOE is usually made by a constellation of clinical, microbiological and radiological features. The first attempt at defining diagnostic criteria for MOE was in 1987, when Cohen and Friedman named several obligatory signs such as pain, exudate, edema, granulation tissue in the external ear canal, the presence of microabscesses if surgery is performed, and either a positive Tc‐99m bone scan or failure of local treatment for 1 week.12
Recent literature reviews emphasize that a positive bacterial or fungal culture of the external ear canal can help make the diagnosis of MOE.4 A recent study looking at diagnostic criteria noted that MOE may be present even without meeting all of these major criteria (clinical, microbiological, and radiological features).13 Some authors suggest that ear biopsy be considered if malignancy is a reasonable possibility.9
Other laboratory data can be within normal limits, such as a WBC count or differential and metabolic profiles.4 Erythrocyte sedimentation rate (ESR), while non‐specific, has been reported to be markedly increased in the setting of MOE.5 It is recommended that a baseline ESR be obtained, and then used to follow the response to treatment.14
Computed tomography (CT) scanning is considered the appropriate initial imaging study, however, there are mixed reports about whether a CT scan alone is enough to evaluate disease severity and its complications.15 While CT scan is quite sensitive for demonstrating bony destruction associated with MOE, MRI is better at detecting the soft tissue changes associated with MOE and more useful for following disease resolution after treatment.16
The treatment of MOE has evolved over time. Before the introduction of effective anti‐pseudomonal antibiotics, MOE had an associated mortality near 50%, and surgery was the recommended therapy.17 Currently, given the availability of effective anti‐pseudomonal therapy, there is usually no indication for surgery as a primary treatment in MOE. For sensitive pseudomonal species, oral Ciprofloxacin therapy for 6 to 8 weeks is considered the treatment of choice for MOE.18 Clinicians should be aware of the emergence of quinolone resistance in P. Aeruginosa,19 and antibiotic sensitivities should be performed on the culture to guide further treatment. In the setting of resistant or multi‐species infection, one should obtain external ear canal biopsy with wound debridement and begin long‐term intravenous therapy with an antipseudomonal beta‐lactam plus an aminoglycoside.18 In the setting of extension into the cranium causing cerebritis or abscess, it is recommended that a neurosurgeon be consulted immediately to determine whether the lesion is amenable to aspiration, excision, or watchful waiting with imaging follow up.
This case illustrates a serious complication from MOE, with ipsilateral facial nerve palsy, opthalmitis, mastoiditis, and cerebral abscess that was successfully treated with conservative medical management.
- .Malignant external otitis.Laryngoscope.1968;78:1257.
- ,,, et al.Necrotizing external otitis in patients with AIDS.Laryngoscope.1997;107:456.
- ,,,.Malignant external otitis in an infant.J Laryngol Otol.1990;104(6):488–490.
- ,,.The changing face of malignant (necrotising) external otitis: clinical, radiological, and anatomic correlations.Lancet Infect Dis.2004;4:34.
- ,.Malignant external otitis: insights into pathogenesis, clinical manifestations, diagnosis, and therapy.Am J Med.1988;85:391.
- ,,Staphylococcal malignant external otitis.Can Med Assoc J.1982;126:155.
- ,,, et al.A case of malignant external otitis involving Klebsiella oxytoca.Eur J Clin Microbiol Infect Dis.1992;11:75.
- ,.Invasive otitis externa due to Aspergillus species: case report and review.Clin Infect Dis.1994;19:866.
- ,.Necrotizing (malignant) external otitis.Am Fam Physician.2003;68(2):309–312.
- ,,,.Bacterial flora of the external canal in diabetics and non‐diabetics.Laryngoscope.1982;92:672.
- ,,.Neurologic complications of malignant external otitis.Neurology.1971;21:1077–1084.
- ,.The diagnostic criteria of malignant external otitis.J Laryngol Otol.1987;101:216–221.
- ,,,,.Stratification for malignant external otitis.Otolaryngol Head Neck Surg.2007;137(2):301–305.
- ,,,,,.Efficacy of oral ciprofloxacin plus rifampin for treatment of malignant external otitis.Arch Otolaryngol Head Neck Surg.1989;115:1063–1069.
- ,,,,,.Usefulness of CT scans in malignant external otitis: effective tool for the diagnosis, but of limited value in predicting outcome.Eur Arch Otorhinolaryngol.2008;265(1):53–56.
- ,,.Use of magnetic resonance imaging as the primary imaging modality in the diagnosis and follow‐up of malignant external otitis.J Laryngol Otol.2004;118:576.
- ,.Skull base osteomyelitis. Malignant external otitis.Otolaryngol Clin North Am.1996;29(5):795–806.
- .Ciprofloxacin: an oral quinolone for the treatment of infections with gram‐negative pathogens. Committee on Antimicrobial Agents. Canadian Infectious Disease Society.Can Med Assoc J.1994;150(5):669–676.
- ,,,.Resistance of Pseudomonas to ciprofloxacin: implications for the treatment of malignant otitis externa.J Laryngol Otol.2007;121:118–123.
Malignant Otitis Externa (MOE) is a necrotizing infection of the external auditory canal characterized by extension into nearby soft tissue and bony structures that can potentially lead to mastoiditis, skull base osteomyelitis, cranial nerve palsies, and rarely, intracranial complications. MOE has been classically described as a disease affecting elderly diabetics1 and has been reported in immunocompromised patients with acquired immune deficiency syndrome (AIDS), malignancy, patients receiving chemotherapy, and neutropenic children.24 The incidence of MOE in the general population is estimated to be quite low and difficult to determine.5 However, over the past decades, the number of reported cases has been increasing, suggesting increased awareness of this syndrome by primary care physicians.6
Case Report
A 56‐year‐old white male was brought to the emergency department with altered mental status including decreased level of consciousness, bizarre behavior, headaches, and nausea for several weeks. He had a history of alcohol and cocaine abuse. He was homeless and a smoker. On examination, the patient was lethargic, disoriented with respect to time, place and person. Blood pressure was 107/72 mm Hg, heart rate 85 beats per minute; respirations were 16 per minute and temperature was 97.9F. Neurological examination was significant for loss of vision of the left eye and left facial peripheral nerve palsy. Examination of the left eye showed yellowish‐greenish discharge, a lower lid ectropium with upper lid ptosis, conjunctival erythema, and an 8 mm 6 mm abrasion in the medial half of the cornea. He had purulent drainage from the left ear with small vesicular lesions on the auricle, and a 3 cm 4 cm abscess on the right forearm. The remainder of the physical examination was unremarkable.
Laboratory‐test results showed white blood cell (WBC) count; 11.27 109 cells/L with 76.6% neutrophils. A complete metabolic panel was within normal limits. Human immunodeficiency virus (HIV) and RPR testing were negative. Cerebrospinal fluid (CSF) studies demonstrated a WBC 39 cells/mm3 with lymphocytes predominance (85%), Red blood cell (RBC) 6 cells/mm3, protein 48 mg/dL, and glucose; 63 mg/dL. Computed tomographic scan of the head revealed an area of low attenuation with surrounding edema of the left temporal lobe and fracture of the temporal bone on the superior margin of the mastoid air cells extending into the left mastoid air cells (Figure 1). The fluid draining from the patient's left ear grew 2 different strains of Pseudomonas aeruginosa. Magnetic resonance imaging (MRI) of the brain demonstrated a 2.5 cm to 3.0 cm region of multiple loculations and edema in the left temporal lobe representing cerebritis with abscess and complete opacification of left mastoid air cell suggestive of mastoiditis (Figure 2). Piperacillin/tazobactam and tobramycin were initiated for suspected MOE with brain involvement. CSF and blood cultures were negative.
A repeat MRI at 3 weeks of therapy demonstrated interval improvement in the temporal lobe abscess and the edema surrounding the infection. At the time of discharge, after 6 weeks of antimicrobial therapy, the patient was alert and oriented with respect to person, place, and time.
Discussion
Pseudomonas aeruginosa is the most common organism cultured from MOE.4, 5 Other organisms such as Staphylococcus aureus,6 Proteus mirabilis, Klebsiella oxytocea,7 and Aspergillus species8 have been reported as well.
While the exact pathogenesis of MOE is poorly understood, accidental trauma from cotton swabs, exposure to lake water, swimming pool water, and repeated aural lavage have all been implicated as inciting factors.9 The current literature suggests that Pseudomonal otitis externa occurs due to abnormal host defense mechanisms rather than enhanced pathogen colonization.10
MOE typically presents with severe otalgia, headache, auricular tenderness, mastoid tenderness, or persistent otorrhea. The pain of MOE is usually severe, and the classic signs of infection such as fever, leukocytosis and neutrophil predominance (left shift) may not be present.5 The diagnosis can be confirmed by otoscopic exam which will demonstrate granulation tissue at the junction between the bony and cartilaginous tissues in the external auditory canal. MOE can produce certain physical findings that should raise red flags for local extension. Temporomandibular joint pain in the susceptible patient with otalgia could indicate MOE with joint invasion. Cranial nerve involvement, most commonly involves the seventh cranial nerve which results in a facial palsy. Other cranial neuropathies have been reported in MOE such as the glossopharyngeal, vagal, spinal accessory, and hypoglossal nerves.11 Confusion and nuchal rigidity should arouse suspicion of intracranial extension of the infection.
The diagnosis of MOE is usually made by a constellation of clinical, microbiological and radiological features. The first attempt at defining diagnostic criteria for MOE was in 1987, when Cohen and Friedman named several obligatory signs such as pain, exudate, edema, granulation tissue in the external ear canal, the presence of microabscesses if surgery is performed, and either a positive Tc‐99m bone scan or failure of local treatment for 1 week.12
Recent literature reviews emphasize that a positive bacterial or fungal culture of the external ear canal can help make the diagnosis of MOE.4 A recent study looking at diagnostic criteria noted that MOE may be present even without meeting all of these major criteria (clinical, microbiological, and radiological features).13 Some authors suggest that ear biopsy be considered if malignancy is a reasonable possibility.9
Other laboratory data can be within normal limits, such as a WBC count or differential and metabolic profiles.4 Erythrocyte sedimentation rate (ESR), while non‐specific, has been reported to be markedly increased in the setting of MOE.5 It is recommended that a baseline ESR be obtained, and then used to follow the response to treatment.14
Computed tomography (CT) scanning is considered the appropriate initial imaging study, however, there are mixed reports about whether a CT scan alone is enough to evaluate disease severity and its complications.15 While CT scan is quite sensitive for demonstrating bony destruction associated with MOE, MRI is better at detecting the soft tissue changes associated with MOE and more useful for following disease resolution after treatment.16
The treatment of MOE has evolved over time. Before the introduction of effective anti‐pseudomonal antibiotics, MOE had an associated mortality near 50%, and surgery was the recommended therapy.17 Currently, given the availability of effective anti‐pseudomonal therapy, there is usually no indication for surgery as a primary treatment in MOE. For sensitive pseudomonal species, oral Ciprofloxacin therapy for 6 to 8 weeks is considered the treatment of choice for MOE.18 Clinicians should be aware of the emergence of quinolone resistance in P. Aeruginosa,19 and antibiotic sensitivities should be performed on the culture to guide further treatment. In the setting of resistant or multi‐species infection, one should obtain external ear canal biopsy with wound debridement and begin long‐term intravenous therapy with an antipseudomonal beta‐lactam plus an aminoglycoside.18 In the setting of extension into the cranium causing cerebritis or abscess, it is recommended that a neurosurgeon be consulted immediately to determine whether the lesion is amenable to aspiration, excision, or watchful waiting with imaging follow up.
This case illustrates a serious complication from MOE, with ipsilateral facial nerve palsy, opthalmitis, mastoiditis, and cerebral abscess that was successfully treated with conservative medical management.
Malignant Otitis Externa (MOE) is a necrotizing infection of the external auditory canal characterized by extension into nearby soft tissue and bony structures that can potentially lead to mastoiditis, skull base osteomyelitis, cranial nerve palsies, and rarely, intracranial complications. MOE has been classically described as a disease affecting elderly diabetics1 and has been reported in immunocompromised patients with acquired immune deficiency syndrome (AIDS), malignancy, patients receiving chemotherapy, and neutropenic children.24 The incidence of MOE in the general population is estimated to be quite low and difficult to determine.5 However, over the past decades, the number of reported cases has been increasing, suggesting increased awareness of this syndrome by primary care physicians.6
Case Report
A 56‐year‐old white male was brought to the emergency department with altered mental status including decreased level of consciousness, bizarre behavior, headaches, and nausea for several weeks. He had a history of alcohol and cocaine abuse. He was homeless and a smoker. On examination, the patient was lethargic, disoriented with respect to time, place and person. Blood pressure was 107/72 mm Hg, heart rate 85 beats per minute; respirations were 16 per minute and temperature was 97.9F. Neurological examination was significant for loss of vision of the left eye and left facial peripheral nerve palsy. Examination of the left eye showed yellowish‐greenish discharge, a lower lid ectropium with upper lid ptosis, conjunctival erythema, and an 8 mm 6 mm abrasion in the medial half of the cornea. He had purulent drainage from the left ear with small vesicular lesions on the auricle, and a 3 cm 4 cm abscess on the right forearm. The remainder of the physical examination was unremarkable.
Laboratory‐test results showed white blood cell (WBC) count; 11.27 109 cells/L with 76.6% neutrophils. A complete metabolic panel was within normal limits. Human immunodeficiency virus (HIV) and RPR testing were negative. Cerebrospinal fluid (CSF) studies demonstrated a WBC 39 cells/mm3 with lymphocytes predominance (85%), Red blood cell (RBC) 6 cells/mm3, protein 48 mg/dL, and glucose; 63 mg/dL. Computed tomographic scan of the head revealed an area of low attenuation with surrounding edema of the left temporal lobe and fracture of the temporal bone on the superior margin of the mastoid air cells extending into the left mastoid air cells (Figure 1). The fluid draining from the patient's left ear grew 2 different strains of Pseudomonas aeruginosa. Magnetic resonance imaging (MRI) of the brain demonstrated a 2.5 cm to 3.0 cm region of multiple loculations and edema in the left temporal lobe representing cerebritis with abscess and complete opacification of left mastoid air cell suggestive of mastoiditis (Figure 2). Piperacillin/tazobactam and tobramycin were initiated for suspected MOE with brain involvement. CSF and blood cultures were negative.
A repeat MRI at 3 weeks of therapy demonstrated interval improvement in the temporal lobe abscess and the edema surrounding the infection. At the time of discharge, after 6 weeks of antimicrobial therapy, the patient was alert and oriented with respect to person, place, and time.
Discussion
Pseudomonas aeruginosa is the most common organism cultured from MOE.4, 5 Other organisms such as Staphylococcus aureus,6 Proteus mirabilis, Klebsiella oxytocea,7 and Aspergillus species8 have been reported as well.
While the exact pathogenesis of MOE is poorly understood, accidental trauma from cotton swabs, exposure to lake water, swimming pool water, and repeated aural lavage have all been implicated as inciting factors.9 The current literature suggests that Pseudomonal otitis externa occurs due to abnormal host defense mechanisms rather than enhanced pathogen colonization.10
MOE typically presents with severe otalgia, headache, auricular tenderness, mastoid tenderness, or persistent otorrhea. The pain of MOE is usually severe, and the classic signs of infection such as fever, leukocytosis and neutrophil predominance (left shift) may not be present.5 The diagnosis can be confirmed by otoscopic exam which will demonstrate granulation tissue at the junction between the bony and cartilaginous tissues in the external auditory canal. MOE can produce certain physical findings that should raise red flags for local extension. Temporomandibular joint pain in the susceptible patient with otalgia could indicate MOE with joint invasion. Cranial nerve involvement, most commonly involves the seventh cranial nerve which results in a facial palsy. Other cranial neuropathies have been reported in MOE such as the glossopharyngeal, vagal, spinal accessory, and hypoglossal nerves.11 Confusion and nuchal rigidity should arouse suspicion of intracranial extension of the infection.
The diagnosis of MOE is usually made by a constellation of clinical, microbiological and radiological features. The first attempt at defining diagnostic criteria for MOE was in 1987, when Cohen and Friedman named several obligatory signs such as pain, exudate, edema, granulation tissue in the external ear canal, the presence of microabscesses if surgery is performed, and either a positive Tc‐99m bone scan or failure of local treatment for 1 week.12
Recent literature reviews emphasize that a positive bacterial or fungal culture of the external ear canal can help make the diagnosis of MOE.4 A recent study looking at diagnostic criteria noted that MOE may be present even without meeting all of these major criteria (clinical, microbiological, and radiological features).13 Some authors suggest that ear biopsy be considered if malignancy is a reasonable possibility.9
Other laboratory data can be within normal limits, such as a WBC count or differential and metabolic profiles.4 Erythrocyte sedimentation rate (ESR), while non‐specific, has been reported to be markedly increased in the setting of MOE.5 It is recommended that a baseline ESR be obtained, and then used to follow the response to treatment.14
Computed tomography (CT) scanning is considered the appropriate initial imaging study, however, there are mixed reports about whether a CT scan alone is enough to evaluate disease severity and its complications.15 While CT scan is quite sensitive for demonstrating bony destruction associated with MOE, MRI is better at detecting the soft tissue changes associated with MOE and more useful for following disease resolution after treatment.16
The treatment of MOE has evolved over time. Before the introduction of effective anti‐pseudomonal antibiotics, MOE had an associated mortality near 50%, and surgery was the recommended therapy.17 Currently, given the availability of effective anti‐pseudomonal therapy, there is usually no indication for surgery as a primary treatment in MOE. For sensitive pseudomonal species, oral Ciprofloxacin therapy for 6 to 8 weeks is considered the treatment of choice for MOE.18 Clinicians should be aware of the emergence of quinolone resistance in P. Aeruginosa,19 and antibiotic sensitivities should be performed on the culture to guide further treatment. In the setting of resistant or multi‐species infection, one should obtain external ear canal biopsy with wound debridement and begin long‐term intravenous therapy with an antipseudomonal beta‐lactam plus an aminoglycoside.18 In the setting of extension into the cranium causing cerebritis or abscess, it is recommended that a neurosurgeon be consulted immediately to determine whether the lesion is amenable to aspiration, excision, or watchful waiting with imaging follow up.
This case illustrates a serious complication from MOE, with ipsilateral facial nerve palsy, opthalmitis, mastoiditis, and cerebral abscess that was successfully treated with conservative medical management.
- .Malignant external otitis.Laryngoscope.1968;78:1257.
- ,,, et al.Necrotizing external otitis in patients with AIDS.Laryngoscope.1997;107:456.
- ,,,.Malignant external otitis in an infant.J Laryngol Otol.1990;104(6):488–490.
- ,,.The changing face of malignant (necrotising) external otitis: clinical, radiological, and anatomic correlations.Lancet Infect Dis.2004;4:34.
- ,.Malignant external otitis: insights into pathogenesis, clinical manifestations, diagnosis, and therapy.Am J Med.1988;85:391.
- ,,Staphylococcal malignant external otitis.Can Med Assoc J.1982;126:155.
- ,,, et al.A case of malignant external otitis involving Klebsiella oxytoca.Eur J Clin Microbiol Infect Dis.1992;11:75.
- ,.Invasive otitis externa due to Aspergillus species: case report and review.Clin Infect Dis.1994;19:866.
- ,.Necrotizing (malignant) external otitis.Am Fam Physician.2003;68(2):309–312.
- ,,,.Bacterial flora of the external canal in diabetics and non‐diabetics.Laryngoscope.1982;92:672.
- ,,.Neurologic complications of malignant external otitis.Neurology.1971;21:1077–1084.
- ,.The diagnostic criteria of malignant external otitis.J Laryngol Otol.1987;101:216–221.
- ,,,,.Stratification for malignant external otitis.Otolaryngol Head Neck Surg.2007;137(2):301–305.
- ,,,,,.Efficacy of oral ciprofloxacin plus rifampin for treatment of malignant external otitis.Arch Otolaryngol Head Neck Surg.1989;115:1063–1069.
- ,,,,,.Usefulness of CT scans in malignant external otitis: effective tool for the diagnosis, but of limited value in predicting outcome.Eur Arch Otorhinolaryngol.2008;265(1):53–56.
- ,,.Use of magnetic resonance imaging as the primary imaging modality in the diagnosis and follow‐up of malignant external otitis.J Laryngol Otol.2004;118:576.
- ,.Skull base osteomyelitis. Malignant external otitis.Otolaryngol Clin North Am.1996;29(5):795–806.
- .Ciprofloxacin: an oral quinolone for the treatment of infections with gram‐negative pathogens. Committee on Antimicrobial Agents. Canadian Infectious Disease Society.Can Med Assoc J.1994;150(5):669–676.
- ,,,.Resistance of Pseudomonas to ciprofloxacin: implications for the treatment of malignant otitis externa.J Laryngol Otol.2007;121:118–123.
- .Malignant external otitis.Laryngoscope.1968;78:1257.
- ,,, et al.Necrotizing external otitis in patients with AIDS.Laryngoscope.1997;107:456.
- ,,,.Malignant external otitis in an infant.J Laryngol Otol.1990;104(6):488–490.
- ,,.The changing face of malignant (necrotising) external otitis: clinical, radiological, and anatomic correlations.Lancet Infect Dis.2004;4:34.
- ,.Malignant external otitis: insights into pathogenesis, clinical manifestations, diagnosis, and therapy.Am J Med.1988;85:391.
- ,,Staphylococcal malignant external otitis.Can Med Assoc J.1982;126:155.
- ,,, et al.A case of malignant external otitis involving Klebsiella oxytoca.Eur J Clin Microbiol Infect Dis.1992;11:75.
- ,.Invasive otitis externa due to Aspergillus species: case report and review.Clin Infect Dis.1994;19:866.
- ,.Necrotizing (malignant) external otitis.Am Fam Physician.2003;68(2):309–312.
- ,,,.Bacterial flora of the external canal in diabetics and non‐diabetics.Laryngoscope.1982;92:672.
- ,,.Neurologic complications of malignant external otitis.Neurology.1971;21:1077–1084.
- ,.The diagnostic criteria of malignant external otitis.J Laryngol Otol.1987;101:216–221.
- ,,,,.Stratification for malignant external otitis.Otolaryngol Head Neck Surg.2007;137(2):301–305.
- ,,,,,.Efficacy of oral ciprofloxacin plus rifampin for treatment of malignant external otitis.Arch Otolaryngol Head Neck Surg.1989;115:1063–1069.
- ,,,,,.Usefulness of CT scans in malignant external otitis: effective tool for the diagnosis, but of limited value in predicting outcome.Eur Arch Otorhinolaryngol.2008;265(1):53–56.
- ,,.Use of magnetic resonance imaging as the primary imaging modality in the diagnosis and follow‐up of malignant external otitis.J Laryngol Otol.2004;118:576.
- ,.Skull base osteomyelitis. Malignant external otitis.Otolaryngol Clin North Am.1996;29(5):795–806.
- .Ciprofloxacin: an oral quinolone for the treatment of infections with gram‐negative pathogens. Committee on Antimicrobial Agents. Canadian Infectious Disease Society.Can Med Assoc J.1994;150(5):669–676.
- ,,,.Resistance of Pseudomonas to ciprofloxacin: implications for the treatment of malignant otitis externa.J Laryngol Otol.2007;121:118–123.
Effects of blood conservation on the incidence of anemia and transfusions in pediatric parapneumonic effusion: A hospitalist perspective
Pediatric patients with pneumonia frequently develop parapneumonic effusion (PNE),1 which account for 0.4 to 6 cases per 1000 pediatric admissions.2 The effusion initially is in a transudative, free‐flowing phase that may evolve to fibrino‐purulent phase and a later organizing phase.3 Hospital management includes antibiotic therapy, pain control, fluids, nutritional support, diagnostic imaging and most important is fluid drainage. Fluid drainage could be through thoracentesis, chest tubes,4 fibrinolysis,5 video‐assisted thoracoscopic surgery (VATS),6 or thoracotomy.7
During hospitalization, repeated phlebotomy and surgical procedures result in ongoing blood losses8, 9 while systemic inflammation and nutritional compromise may blunt erythropoiesis.10, 11 Both mechanisms may result in developing anemia and subsequent need for red blood cell transfusion (RBCT). Blood transfusions are associated with multiple complications including transfusion transmitted infections, acute lung injury, hemodynamic compromise, volume overload, hemolysis, and immune compromise.12, 13 Furthermore, suboptimal benefits,14 increased resource utilization,15 and risk of mortality16 have also been reported in Pediatric intensive care unit (ICU) patients who received blood transfusions.
A Pediatric Blood Conservation program was launched at Helen DeVos Children's Hospital in 1999, and since its inception the pediatric hospitalists have implemented blood conservation guidelines (BCG) in the management of some of the patients with PNE. The BCG incorporated into the care of the intervention group (group I) were orders for:
Minimizing phlebotomy draws (without stating a specific frequency).
Use of micro sampling blood collection tubes and reinfusion of any blood drawn prior to obtaining a blood sample (waste return).
Hematinics use at managing physician's discretion (see Supporting Appendices 1 and 2 in the online version of this article).
No previous studies have addressed the impact of blood conservation strategies on the development of anemia in pediatric PNE. We hypothesized that BCG implementation resulted in smaller phlebotomy losses, lesser incidence of anemia, and lower transfusion requirements.
Methods
After obtaining an approval from the institutional review board, a retrospective medical records review was conducted of all pediatric patients (1 month‐18 years) admitted to Helen DeVos Children's Hospital with diagnoses of PNE from the period of January 1997 to December 2004.
Study Groups
Intervention group (group I) included all patients who were admitted with a diagnosis of PNE between the year 2000 to 2004 and had orders for BCG (as outlined above) written on or after admission to the hospital. That group included patients that were either solely managed by the hospitalists or comanaged by both the general pediatrician and the Hospitalist.
Simultaneous nonintervention group (group S) included patients with PNE who were admitted between 2000 to 2004 and did not have BCG orders on their record. Those patients were either managed solely by the general pediatricians or the Hospitalist may have been involved but no BCG orders were written. It was assumed that no intervention was implemented.
Historical nonintervention group (group H) included patients with PNE admitted between 1997 and 2000 prior to the implementation of the blood conservation program or the hospitalists service. Those patients were managed by the general pediatricians with the Intensivists help at times and no blood conservation measures were implemented.
Phlebotomy frequency and volume data were collected from the patient's medical record. When volume was not documented, an estimate was made based on the hospital actual practice and labs reported. If the child had central vascular access, a standard of 2 mL of blood was removed to clear the line prior to drawing the blood sample. In the S and H groups that volume was discarded and recorded as a blood loss. In Group I the blood used to clear the line was returned to the patients. Data regarding the patient's hemoglobin (Hgb) levels on admission and during hospitalization as well as RBCT frequency and volume were also collected. Other background data collected included, hospital stay, ICU admission, antibiotic use, isolated organisms, and PNE‐related interventions (thoracentesis, VATS and chest tube placement). A pediatric risk of mortality score (PRISM score17) was assigned for every patient based on data collected on the day of admission.
Statistical analysis was done using a Fisher exact test to compare qualitative data. For quantitative data Kruskal‐Wallis was used for comparison between the three groups while the Mann Whitney test was used for the pair wise comparisons. Odds Ratios and Confidence Intervals were calculated for variables associated with needing RBCTs.
Results
A total of 81 patients who were admitted to the hospital for medical and surgical management with PNE were included in the study. During the study period 24 patients with blood conservation orders on the chart were assigned to the intervention group. Another 28 patients were identified during the same period but did not have blood conservation orders and were assigned to the simultaneous no intervention group. A historical no intervention group of 29 patients were identified from a 3‐year period prior to the study period. Groups were similar in age, weight, and an overall low PRISM score. Group H tended to have lower acuity, longer hospital stay, more frequent pediatric intensive care unit (PICU) admissions, and tended to have more chest tube days compared to the (I) and (S) groups (Table 1).
| Group I (n = 24) | Group S (n = 28) | Group H (n = 29) | Kruskal‐Wallis P Value | |
|---|---|---|---|---|
| ||||
| Age, years | 6 (4) | 5 (4) | 6 (5) | 0.75 |
| Weight, kg | 26 (19) | 22 (13) | 27 (17) | 0.77 |
| PRISM Score | 2 (3) | 3 (5) | (1) | 0.007* |
| PICU admission number (%) | 3 (12) | 8 (29) | 14 (48) | 0.018 |
| Chest tube days | 7 (4) | 6 (4) | 9 (5) | 0.054 |
| Hospital stay days | 10 (4) | 13 (6) | 15 (6) | 0.008 |
| Initial Hgb, gm | 11.2 (1.7) | 11.2 (1.6) | 11.1 (1.9) | 0.95 |
| Drop in Hgb, gm | 1.7 (1.4) | 2.1 (1.2) | 2 (1.4) | 0.37 |
| Days to Hgb Nadir | 6.1 (37) | 8.5 (5.5) | 6.9 (4.3) | 0.31 |
| Number of blood draws | 7.6 (4) | 11 (9) | 12.6 (12) | 0.36 |
| Phlebotomy volume, mL/kg/day | 0.08 (0.05) | 0.14 (0.33) | 0.22 (0.24) | 0.006 |
| Number of patients transfused (%) | 2 (8.3) | 5 (17.9) | 9 (31) | 0.11 |
All groups (I, S and H) had similar initial Hgb, in‐hospital decline in Hgb levels and time to reach a Hgb nadir. There was a trend toward a lower frequency of phlebotomy and significant difference in the phlebotomy volumes drawn even when corrected for patient weight and hospital stay, (I < S < H; P = 0.006), (Table 1).
All 3 groups had a similar pretransfusion Hgb trigger (7.7 1 gm/dL), timing of transfusions (7.9 1 day), volume of packed red blood cells (PRBCs) (19 15 mL/kg), and magnitude of Hgb rise following transfusions (3.9 1.5 gm/dL). There was a strong trend toward lower transfusion need in the intervention group though it did not reach statistical significance (8.3% [I], 17.9% [S]; and 31% [H]; P = 0.11) (Table 1 and Figure 1). Being in group (S) compared to (I) carried a relative risk of transfusion of 2.14 (confidence interval [CI], 0.4610.06).
Of all study patients, 19.8% received RBCT. Compared to those who did not require transfusions they were significantly younger, smaller (P = 0.001) and had a higher severity of illness score (PRISM) (P = 0.25). Transfused children had lower initial Hgb levels, more frequent phlebotomy, greater volume of blood drawn, and longer hospital stay (P = 0.001) (Table 2 and Figure 2).
| Transfused (n = 16) | Not Transfused (n = 65) | Odds Ratio (95% CI) | |
|---|---|---|---|
| |||
| Ages, years | 3.5 (4) | 6.4 (4) | 0.8 (0.640.99)* |
| Weight, kg | 16.1 (9) | 26.9 (17) | 0.92 (0.851)* |
| Initial Hgb, gm | 9.9 (1) | 11.4 (1) | 0.43 (0.260.71)* |
| Number of blood draws | 20 (12) | 8 (6) | 1.2 (1.091.32)* |
| Total phlebotomy volume, mL | 82 (75) | 23 (25) | 1.03 (1.011.05)* |
| Total phlebotomy volume, mL/kg | 5.9 (7) | 1.1 (1) | 1.97 (1.412.74)* |
| Hospital stay days | 19 (5) | 11 (5) | 1.25 (1.121.4)* |
| PRISM score | 3.4 (6) | 1.6 (3) | P. 25 |
A total of 36% of the patients were pretreated with antibiotics prior to obtaining pleural fluid cultures. Forty‐eight patients (59%) had negative cultures, 22 (27%) grew pneumococcus, 5 patients (6%) had streptococcus A, 2 patients had streptococcus viridans, 3 patients had staphylococci aureus, and 1 patient had Haemophilus influenzae. There was no difference between the study groups regarding the site of effusion, prior antibiotics therapy or culture results.
Discussion
This retrospective study showed that children with PNE had low Hgb upon admission to the hospital and after dropping an average of 2 gm/dL over the first week of hospitalization one‐fifth of the patients required transfusion. The phlebotomy volumes significantly decreased with BCG implementation, and transfusion frequency showed a strong trend toward decline. The fact that all 3 groups had similar pretransfusion Hgb and similar Hgb decline, despite differences in the phlebotomy volumes, may implicate other factors like bone marrow suppression, malnutrition, and procedural blood losses. All of these factors have been shown to contribute to the development of anemia in the critically ill patients10 and were not accounted for in this limited retrospective review.
Transfused patients were significantly smaller, younger, and had higher illness severity scores. They had lower initial Hgb levels, more phlebotomy, and longer hospital stay than nontransfused patients.
Pretransfusion Hgb was 7.5 gm/dL to 7.7 gm/dL in all groups, consistent with Lacroix et al's18 report on the safety of lower transfusion threshold in stable PICU patients. BCG resulted in a strong trend toward less transfusion but did not reach statistical significance likely due to the small sample size. It is tempting to hypothesize that aggressive erythropoietin therapy might augment that trend; however, given the relatively short hospital stay (1014 days), erythropoietin therapy may be less efficacious in the milder case with shorter hospital stay than those with longer hospitalization. After encouraging smaller studies19 Corwin et al.20 did not find a beneficial effect for erythropoietin in adult ICU patients nor did Jacobs et al.21 in ventilated children with bronchiolitis who had comparable length of hospitalization.
A specific benefit could not be attributed to iron/folate or erythropoietin therapy as neither the dosing, duration nor timing was controlled. Furthermore, given the limitations of retrospective reviews, the relative importance of the beneficial effect of limiting phlebotomy vs. hematinics use could not be determined.
The Hospitalist is focused on improving the quality and efficiency of caring for the inpatient.2225 The initiation of the hospitalist's service at our institution coincided with that of the blood conservation service. Consequently, the Hospitalist contributed to patient care as well as daily house staff and nursing education. For those children whose care was coordinated by the hospitalists, the study data showed a trend toward lesser admissions to the PICU and lower blood utilization. This trend further emphasizes the role a Hospitalist could play in adopting and implementing useful medical strategies lowering the cost of care. In this study, a change in patient care was observed over time with the hospitalists tending to employ more blood conservation measures when compared to the pediatrician.
In summary, children with PNE are at risk for developing severe anemia requiring transfusion. This retrospective study identified the characteristics of those likely to require transfusions. Blood conservation strategies seem to decrease the need for transfusions. The hospitalists played an important role in implementing the BCG. A prospective controlled study with adequate power is needed to examine both the various mechanisms for developing anemia and the impact of the individual components of the blood conservation strategies.
- ,.Thoracic empyema.Surg Clin North Am.2002;82:643–671.
- ,.Parapneumonic Pleural effusion and empyema in children: review of 19 year experience.Clin Pediatr (Phila).1983;22:414–419.
- American Thoracic Society.Management of nontuberculosis empyema.Am Rev Respir Dis.1962;85:935–936.
- ,,, et al.Short‐term course and outcome of treatments of pleural empyema in pediatric patients: repeated ultrasound‐guided needle thoracentesis vs. chest tube drainage.Chest.2002;121:836–840.
- ,,, et al.Randomized trial of Intrapleural Urokinase in the treatment of childhood empyema.Thorax.2002;57:343–347.
- ,,,,.Therapy of parapneumonic effusion in children: video‐assisted thoracoscopic surgery versus conventional thoracostomy drainage.Pediatrics.2006;118:e547–e553.
- ,,,.Is open thoracotomy still a good treatment option for the management of Empyema in children?Ann Thorac Surg.2003;76:1854–1858.
- ,,, et al.Anemia, blood loss, and blood transfusions in North American children in the intensive care unit.Am J Respir Crit Care Med.2008;178:25–33.
- .Medical vampires.N Engl J Med.1983;314:1250–1251.
- ,,, et al.Important role of nondiagnostic blood loss and blunted erythropoietic response in the anemia of medical intensive care patients.Crit Care Med.1999;27:2630–2639.
- ,,, et al.Erythropoietin response is blunted in critically ill patients.Intensive Care Med.1997;23:159–162.
- ,.The continuing risk of transfusion‐transmitted infections.N Engl J Med.2006;355:1303–1305.
- ,.Immunomodulation by blood transfusion: an evolving scientific and clinical challenge.Am J Med.1996;101:299–308.
- ,,,.Pediatric red blood cell transfusions increase resource use.J Pediatr.2003;142:95–97.
- ,.Effect of blood transfusion on oxygen consumption in pediatric septic shock.Crit Care Med.1990;18:1087–1091.
- ,,,,.Red blood cell transfusion in critically ill children is independently associated with increased mortality.Intensive Care Med.2007;33:1414–1422.
- ,,.PRISM III: an updated pediatric risk of mortality.Crit Care Med.1996;24(5):743–752.
- ,,, et al.Transfusion strategies for patients in pediatric intensive care units.Nw Engl J Med.2007;356:1609–1619.
- ,,, et al.Efficacy of recombinant human erythropoietin in critically ill patients.JAMA.2002;288:2827–2835.
- ,,, et al.EPO Critical Care Trials Group.Efficacy and safety of epoetin alfa in criticall ill patients.Nw Engl J Med.2007;357:965–976.
- ,,.Erythropoietin therapy in children with Bronchiolitis and anemia.Pediatr Crit Care Med.2003;4(1):44–47.
- .The state of hospital medicine in 2008.Med Clin North Am.2008;92:265–273.
- ,,, et al.Impact of a Hospitalist system on length of stay and cost for children with common conditions.Pediatrics.2007;120:267–274.
- ,,,.Comparison of hospitalists and nonhospitalists regarding core measures of pneumonia care.Am J Manag Care.2007;13:129–132.
- ,,.Improved survival with hospitalists in a pediatric intensive care unit.Crit Care Med.2003;31:847–852.
Pediatric patients with pneumonia frequently develop parapneumonic effusion (PNE),1 which account for 0.4 to 6 cases per 1000 pediatric admissions.2 The effusion initially is in a transudative, free‐flowing phase that may evolve to fibrino‐purulent phase and a later organizing phase.3 Hospital management includes antibiotic therapy, pain control, fluids, nutritional support, diagnostic imaging and most important is fluid drainage. Fluid drainage could be through thoracentesis, chest tubes,4 fibrinolysis,5 video‐assisted thoracoscopic surgery (VATS),6 or thoracotomy.7
During hospitalization, repeated phlebotomy and surgical procedures result in ongoing blood losses8, 9 while systemic inflammation and nutritional compromise may blunt erythropoiesis.10, 11 Both mechanisms may result in developing anemia and subsequent need for red blood cell transfusion (RBCT). Blood transfusions are associated with multiple complications including transfusion transmitted infections, acute lung injury, hemodynamic compromise, volume overload, hemolysis, and immune compromise.12, 13 Furthermore, suboptimal benefits,14 increased resource utilization,15 and risk of mortality16 have also been reported in Pediatric intensive care unit (ICU) patients who received blood transfusions.
A Pediatric Blood Conservation program was launched at Helen DeVos Children's Hospital in 1999, and since its inception the pediatric hospitalists have implemented blood conservation guidelines (BCG) in the management of some of the patients with PNE. The BCG incorporated into the care of the intervention group (group I) were orders for:
Minimizing phlebotomy draws (without stating a specific frequency).
Use of micro sampling blood collection tubes and reinfusion of any blood drawn prior to obtaining a blood sample (waste return).
Hematinics use at managing physician's discretion (see Supporting Appendices 1 and 2 in the online version of this article).
No previous studies have addressed the impact of blood conservation strategies on the development of anemia in pediatric PNE. We hypothesized that BCG implementation resulted in smaller phlebotomy losses, lesser incidence of anemia, and lower transfusion requirements.
Methods
After obtaining an approval from the institutional review board, a retrospective medical records review was conducted of all pediatric patients (1 month‐18 years) admitted to Helen DeVos Children's Hospital with diagnoses of PNE from the period of January 1997 to December 2004.
Study Groups
Intervention group (group I) included all patients who were admitted with a diagnosis of PNE between the year 2000 to 2004 and had orders for BCG (as outlined above) written on or after admission to the hospital. That group included patients that were either solely managed by the hospitalists or comanaged by both the general pediatrician and the Hospitalist.
Simultaneous nonintervention group (group S) included patients with PNE who were admitted between 2000 to 2004 and did not have BCG orders on their record. Those patients were either managed solely by the general pediatricians or the Hospitalist may have been involved but no BCG orders were written. It was assumed that no intervention was implemented.
Historical nonintervention group (group H) included patients with PNE admitted between 1997 and 2000 prior to the implementation of the blood conservation program or the hospitalists service. Those patients were managed by the general pediatricians with the Intensivists help at times and no blood conservation measures were implemented.
Phlebotomy frequency and volume data were collected from the patient's medical record. When volume was not documented, an estimate was made based on the hospital actual practice and labs reported. If the child had central vascular access, a standard of 2 mL of blood was removed to clear the line prior to drawing the blood sample. In the S and H groups that volume was discarded and recorded as a blood loss. In Group I the blood used to clear the line was returned to the patients. Data regarding the patient's hemoglobin (Hgb) levels on admission and during hospitalization as well as RBCT frequency and volume were also collected. Other background data collected included, hospital stay, ICU admission, antibiotic use, isolated organisms, and PNE‐related interventions (thoracentesis, VATS and chest tube placement). A pediatric risk of mortality score (PRISM score17) was assigned for every patient based on data collected on the day of admission.
Statistical analysis was done using a Fisher exact test to compare qualitative data. For quantitative data Kruskal‐Wallis was used for comparison between the three groups while the Mann Whitney test was used for the pair wise comparisons. Odds Ratios and Confidence Intervals were calculated for variables associated with needing RBCTs.
Results
A total of 81 patients who were admitted to the hospital for medical and surgical management with PNE were included in the study. During the study period 24 patients with blood conservation orders on the chart were assigned to the intervention group. Another 28 patients were identified during the same period but did not have blood conservation orders and were assigned to the simultaneous no intervention group. A historical no intervention group of 29 patients were identified from a 3‐year period prior to the study period. Groups were similar in age, weight, and an overall low PRISM score. Group H tended to have lower acuity, longer hospital stay, more frequent pediatric intensive care unit (PICU) admissions, and tended to have more chest tube days compared to the (I) and (S) groups (Table 1).
| Group I (n = 24) | Group S (n = 28) | Group H (n = 29) | Kruskal‐Wallis P Value | |
|---|---|---|---|---|
| ||||
| Age, years | 6 (4) | 5 (4) | 6 (5) | 0.75 |
| Weight, kg | 26 (19) | 22 (13) | 27 (17) | 0.77 |
| PRISM Score | 2 (3) | 3 (5) | (1) | 0.007* |
| PICU admission number (%) | 3 (12) | 8 (29) | 14 (48) | 0.018 |
| Chest tube days | 7 (4) | 6 (4) | 9 (5) | 0.054 |
| Hospital stay days | 10 (4) | 13 (6) | 15 (6) | 0.008 |
| Initial Hgb, gm | 11.2 (1.7) | 11.2 (1.6) | 11.1 (1.9) | 0.95 |
| Drop in Hgb, gm | 1.7 (1.4) | 2.1 (1.2) | 2 (1.4) | 0.37 |
| Days to Hgb Nadir | 6.1 (37) | 8.5 (5.5) | 6.9 (4.3) | 0.31 |
| Number of blood draws | 7.6 (4) | 11 (9) | 12.6 (12) | 0.36 |
| Phlebotomy volume, mL/kg/day | 0.08 (0.05) | 0.14 (0.33) | 0.22 (0.24) | 0.006 |
| Number of patients transfused (%) | 2 (8.3) | 5 (17.9) | 9 (31) | 0.11 |
All groups (I, S and H) had similar initial Hgb, in‐hospital decline in Hgb levels and time to reach a Hgb nadir. There was a trend toward a lower frequency of phlebotomy and significant difference in the phlebotomy volumes drawn even when corrected for patient weight and hospital stay, (I < S < H; P = 0.006), (Table 1).
All 3 groups had a similar pretransfusion Hgb trigger (7.7 1 gm/dL), timing of transfusions (7.9 1 day), volume of packed red blood cells (PRBCs) (19 15 mL/kg), and magnitude of Hgb rise following transfusions (3.9 1.5 gm/dL). There was a strong trend toward lower transfusion need in the intervention group though it did not reach statistical significance (8.3% [I], 17.9% [S]; and 31% [H]; P = 0.11) (Table 1 and Figure 1). Being in group (S) compared to (I) carried a relative risk of transfusion of 2.14 (confidence interval [CI], 0.4610.06).
Of all study patients, 19.8% received RBCT. Compared to those who did not require transfusions they were significantly younger, smaller (P = 0.001) and had a higher severity of illness score (PRISM) (P = 0.25). Transfused children had lower initial Hgb levels, more frequent phlebotomy, greater volume of blood drawn, and longer hospital stay (P = 0.001) (Table 2 and Figure 2).
| Transfused (n = 16) | Not Transfused (n = 65) | Odds Ratio (95% CI) | |
|---|---|---|---|
| |||
| Ages, years | 3.5 (4) | 6.4 (4) | 0.8 (0.640.99)* |
| Weight, kg | 16.1 (9) | 26.9 (17) | 0.92 (0.851)* |
| Initial Hgb, gm | 9.9 (1) | 11.4 (1) | 0.43 (0.260.71)* |
| Number of blood draws | 20 (12) | 8 (6) | 1.2 (1.091.32)* |
| Total phlebotomy volume, mL | 82 (75) | 23 (25) | 1.03 (1.011.05)* |
| Total phlebotomy volume, mL/kg | 5.9 (7) | 1.1 (1) | 1.97 (1.412.74)* |
| Hospital stay days | 19 (5) | 11 (5) | 1.25 (1.121.4)* |
| PRISM score | 3.4 (6) | 1.6 (3) | P. 25 |
A total of 36% of the patients were pretreated with antibiotics prior to obtaining pleural fluid cultures. Forty‐eight patients (59%) had negative cultures, 22 (27%) grew pneumococcus, 5 patients (6%) had streptococcus A, 2 patients had streptococcus viridans, 3 patients had staphylococci aureus, and 1 patient had Haemophilus influenzae. There was no difference between the study groups regarding the site of effusion, prior antibiotics therapy or culture results.
Discussion
This retrospective study showed that children with PNE had low Hgb upon admission to the hospital and after dropping an average of 2 gm/dL over the first week of hospitalization one‐fifth of the patients required transfusion. The phlebotomy volumes significantly decreased with BCG implementation, and transfusion frequency showed a strong trend toward decline. The fact that all 3 groups had similar pretransfusion Hgb and similar Hgb decline, despite differences in the phlebotomy volumes, may implicate other factors like bone marrow suppression, malnutrition, and procedural blood losses. All of these factors have been shown to contribute to the development of anemia in the critically ill patients10 and were not accounted for in this limited retrospective review.
Transfused patients were significantly smaller, younger, and had higher illness severity scores. They had lower initial Hgb levels, more phlebotomy, and longer hospital stay than nontransfused patients.
Pretransfusion Hgb was 7.5 gm/dL to 7.7 gm/dL in all groups, consistent with Lacroix et al's18 report on the safety of lower transfusion threshold in stable PICU patients. BCG resulted in a strong trend toward less transfusion but did not reach statistical significance likely due to the small sample size. It is tempting to hypothesize that aggressive erythropoietin therapy might augment that trend; however, given the relatively short hospital stay (1014 days), erythropoietin therapy may be less efficacious in the milder case with shorter hospital stay than those with longer hospitalization. After encouraging smaller studies19 Corwin et al.20 did not find a beneficial effect for erythropoietin in adult ICU patients nor did Jacobs et al.21 in ventilated children with bronchiolitis who had comparable length of hospitalization.
A specific benefit could not be attributed to iron/folate or erythropoietin therapy as neither the dosing, duration nor timing was controlled. Furthermore, given the limitations of retrospective reviews, the relative importance of the beneficial effect of limiting phlebotomy vs. hematinics use could not be determined.
The Hospitalist is focused on improving the quality and efficiency of caring for the inpatient.2225 The initiation of the hospitalist's service at our institution coincided with that of the blood conservation service. Consequently, the Hospitalist contributed to patient care as well as daily house staff and nursing education. For those children whose care was coordinated by the hospitalists, the study data showed a trend toward lesser admissions to the PICU and lower blood utilization. This trend further emphasizes the role a Hospitalist could play in adopting and implementing useful medical strategies lowering the cost of care. In this study, a change in patient care was observed over time with the hospitalists tending to employ more blood conservation measures when compared to the pediatrician.
In summary, children with PNE are at risk for developing severe anemia requiring transfusion. This retrospective study identified the characteristics of those likely to require transfusions. Blood conservation strategies seem to decrease the need for transfusions. The hospitalists played an important role in implementing the BCG. A prospective controlled study with adequate power is needed to examine both the various mechanisms for developing anemia and the impact of the individual components of the blood conservation strategies.
Pediatric patients with pneumonia frequently develop parapneumonic effusion (PNE),1 which account for 0.4 to 6 cases per 1000 pediatric admissions.2 The effusion initially is in a transudative, free‐flowing phase that may evolve to fibrino‐purulent phase and a later organizing phase.3 Hospital management includes antibiotic therapy, pain control, fluids, nutritional support, diagnostic imaging and most important is fluid drainage. Fluid drainage could be through thoracentesis, chest tubes,4 fibrinolysis,5 video‐assisted thoracoscopic surgery (VATS),6 or thoracotomy.7
During hospitalization, repeated phlebotomy and surgical procedures result in ongoing blood losses8, 9 while systemic inflammation and nutritional compromise may blunt erythropoiesis.10, 11 Both mechanisms may result in developing anemia and subsequent need for red blood cell transfusion (RBCT). Blood transfusions are associated with multiple complications including transfusion transmitted infections, acute lung injury, hemodynamic compromise, volume overload, hemolysis, and immune compromise.12, 13 Furthermore, suboptimal benefits,14 increased resource utilization,15 and risk of mortality16 have also been reported in Pediatric intensive care unit (ICU) patients who received blood transfusions.
A Pediatric Blood Conservation program was launched at Helen DeVos Children's Hospital in 1999, and since its inception the pediatric hospitalists have implemented blood conservation guidelines (BCG) in the management of some of the patients with PNE. The BCG incorporated into the care of the intervention group (group I) were orders for:
Minimizing phlebotomy draws (without stating a specific frequency).
Use of micro sampling blood collection tubes and reinfusion of any blood drawn prior to obtaining a blood sample (waste return).
Hematinics use at managing physician's discretion (see Supporting Appendices 1 and 2 in the online version of this article).
No previous studies have addressed the impact of blood conservation strategies on the development of anemia in pediatric PNE. We hypothesized that BCG implementation resulted in smaller phlebotomy losses, lesser incidence of anemia, and lower transfusion requirements.
Methods
After obtaining an approval from the institutional review board, a retrospective medical records review was conducted of all pediatric patients (1 month‐18 years) admitted to Helen DeVos Children's Hospital with diagnoses of PNE from the period of January 1997 to December 2004.
Study Groups
Intervention group (group I) included all patients who were admitted with a diagnosis of PNE between the year 2000 to 2004 and had orders for BCG (as outlined above) written on or after admission to the hospital. That group included patients that were either solely managed by the hospitalists or comanaged by both the general pediatrician and the Hospitalist.
Simultaneous nonintervention group (group S) included patients with PNE who were admitted between 2000 to 2004 and did not have BCG orders on their record. Those patients were either managed solely by the general pediatricians or the Hospitalist may have been involved but no BCG orders were written. It was assumed that no intervention was implemented.
Historical nonintervention group (group H) included patients with PNE admitted between 1997 and 2000 prior to the implementation of the blood conservation program or the hospitalists service. Those patients were managed by the general pediatricians with the Intensivists help at times and no blood conservation measures were implemented.
Phlebotomy frequency and volume data were collected from the patient's medical record. When volume was not documented, an estimate was made based on the hospital actual practice and labs reported. If the child had central vascular access, a standard of 2 mL of blood was removed to clear the line prior to drawing the blood sample. In the S and H groups that volume was discarded and recorded as a blood loss. In Group I the blood used to clear the line was returned to the patients. Data regarding the patient's hemoglobin (Hgb) levels on admission and during hospitalization as well as RBCT frequency and volume were also collected. Other background data collected included, hospital stay, ICU admission, antibiotic use, isolated organisms, and PNE‐related interventions (thoracentesis, VATS and chest tube placement). A pediatric risk of mortality score (PRISM score17) was assigned for every patient based on data collected on the day of admission.
Statistical analysis was done using a Fisher exact test to compare qualitative data. For quantitative data Kruskal‐Wallis was used for comparison between the three groups while the Mann Whitney test was used for the pair wise comparisons. Odds Ratios and Confidence Intervals were calculated for variables associated with needing RBCTs.
Results
A total of 81 patients who were admitted to the hospital for medical and surgical management with PNE were included in the study. During the study period 24 patients with blood conservation orders on the chart were assigned to the intervention group. Another 28 patients were identified during the same period but did not have blood conservation orders and were assigned to the simultaneous no intervention group. A historical no intervention group of 29 patients were identified from a 3‐year period prior to the study period. Groups were similar in age, weight, and an overall low PRISM score. Group H tended to have lower acuity, longer hospital stay, more frequent pediatric intensive care unit (PICU) admissions, and tended to have more chest tube days compared to the (I) and (S) groups (Table 1).
| Group I (n = 24) | Group S (n = 28) | Group H (n = 29) | Kruskal‐Wallis P Value | |
|---|---|---|---|---|
| ||||
| Age, years | 6 (4) | 5 (4) | 6 (5) | 0.75 |
| Weight, kg | 26 (19) | 22 (13) | 27 (17) | 0.77 |
| PRISM Score | 2 (3) | 3 (5) | (1) | 0.007* |
| PICU admission number (%) | 3 (12) | 8 (29) | 14 (48) | 0.018 |
| Chest tube days | 7 (4) | 6 (4) | 9 (5) | 0.054 |
| Hospital stay days | 10 (4) | 13 (6) | 15 (6) | 0.008 |
| Initial Hgb, gm | 11.2 (1.7) | 11.2 (1.6) | 11.1 (1.9) | 0.95 |
| Drop in Hgb, gm | 1.7 (1.4) | 2.1 (1.2) | 2 (1.4) | 0.37 |
| Days to Hgb Nadir | 6.1 (37) | 8.5 (5.5) | 6.9 (4.3) | 0.31 |
| Number of blood draws | 7.6 (4) | 11 (9) | 12.6 (12) | 0.36 |
| Phlebotomy volume, mL/kg/day | 0.08 (0.05) | 0.14 (0.33) | 0.22 (0.24) | 0.006 |
| Number of patients transfused (%) | 2 (8.3) | 5 (17.9) | 9 (31) | 0.11 |
All groups (I, S and H) had similar initial Hgb, in‐hospital decline in Hgb levels and time to reach a Hgb nadir. There was a trend toward a lower frequency of phlebotomy and significant difference in the phlebotomy volumes drawn even when corrected for patient weight and hospital stay, (I < S < H; P = 0.006), (Table 1).
All 3 groups had a similar pretransfusion Hgb trigger (7.7 1 gm/dL), timing of transfusions (7.9 1 day), volume of packed red blood cells (PRBCs) (19 15 mL/kg), and magnitude of Hgb rise following transfusions (3.9 1.5 gm/dL). There was a strong trend toward lower transfusion need in the intervention group though it did not reach statistical significance (8.3% [I], 17.9% [S]; and 31% [H]; P = 0.11) (Table 1 and Figure 1). Being in group (S) compared to (I) carried a relative risk of transfusion of 2.14 (confidence interval [CI], 0.4610.06).
Of all study patients, 19.8% received RBCT. Compared to those who did not require transfusions they were significantly younger, smaller (P = 0.001) and had a higher severity of illness score (PRISM) (P = 0.25). Transfused children had lower initial Hgb levels, more frequent phlebotomy, greater volume of blood drawn, and longer hospital stay (P = 0.001) (Table 2 and Figure 2).
| Transfused (n = 16) | Not Transfused (n = 65) | Odds Ratio (95% CI) | |
|---|---|---|---|
| |||
| Ages, years | 3.5 (4) | 6.4 (4) | 0.8 (0.640.99)* |
| Weight, kg | 16.1 (9) | 26.9 (17) | 0.92 (0.851)* |
| Initial Hgb, gm | 9.9 (1) | 11.4 (1) | 0.43 (0.260.71)* |
| Number of blood draws | 20 (12) | 8 (6) | 1.2 (1.091.32)* |
| Total phlebotomy volume, mL | 82 (75) | 23 (25) | 1.03 (1.011.05)* |
| Total phlebotomy volume, mL/kg | 5.9 (7) | 1.1 (1) | 1.97 (1.412.74)* |
| Hospital stay days | 19 (5) | 11 (5) | 1.25 (1.121.4)* |
| PRISM score | 3.4 (6) | 1.6 (3) | P. 25 |
A total of 36% of the patients were pretreated with antibiotics prior to obtaining pleural fluid cultures. Forty‐eight patients (59%) had negative cultures, 22 (27%) grew pneumococcus, 5 patients (6%) had streptococcus A, 2 patients had streptococcus viridans, 3 patients had staphylococci aureus, and 1 patient had Haemophilus influenzae. There was no difference between the study groups regarding the site of effusion, prior antibiotics therapy or culture results.
Discussion
This retrospective study showed that children with PNE had low Hgb upon admission to the hospital and after dropping an average of 2 gm/dL over the first week of hospitalization one‐fifth of the patients required transfusion. The phlebotomy volumes significantly decreased with BCG implementation, and transfusion frequency showed a strong trend toward decline. The fact that all 3 groups had similar pretransfusion Hgb and similar Hgb decline, despite differences in the phlebotomy volumes, may implicate other factors like bone marrow suppression, malnutrition, and procedural blood losses. All of these factors have been shown to contribute to the development of anemia in the critically ill patients10 and were not accounted for in this limited retrospective review.
Transfused patients were significantly smaller, younger, and had higher illness severity scores. They had lower initial Hgb levels, more phlebotomy, and longer hospital stay than nontransfused patients.
Pretransfusion Hgb was 7.5 gm/dL to 7.7 gm/dL in all groups, consistent with Lacroix et al's18 report on the safety of lower transfusion threshold in stable PICU patients. BCG resulted in a strong trend toward less transfusion but did not reach statistical significance likely due to the small sample size. It is tempting to hypothesize that aggressive erythropoietin therapy might augment that trend; however, given the relatively short hospital stay (1014 days), erythropoietin therapy may be less efficacious in the milder case with shorter hospital stay than those with longer hospitalization. After encouraging smaller studies19 Corwin et al.20 did not find a beneficial effect for erythropoietin in adult ICU patients nor did Jacobs et al.21 in ventilated children with bronchiolitis who had comparable length of hospitalization.
A specific benefit could not be attributed to iron/folate or erythropoietin therapy as neither the dosing, duration nor timing was controlled. Furthermore, given the limitations of retrospective reviews, the relative importance of the beneficial effect of limiting phlebotomy vs. hematinics use could not be determined.
The Hospitalist is focused on improving the quality and efficiency of caring for the inpatient.2225 The initiation of the hospitalist's service at our institution coincided with that of the blood conservation service. Consequently, the Hospitalist contributed to patient care as well as daily house staff and nursing education. For those children whose care was coordinated by the hospitalists, the study data showed a trend toward lesser admissions to the PICU and lower blood utilization. This trend further emphasizes the role a Hospitalist could play in adopting and implementing useful medical strategies lowering the cost of care. In this study, a change in patient care was observed over time with the hospitalists tending to employ more blood conservation measures when compared to the pediatrician.
In summary, children with PNE are at risk for developing severe anemia requiring transfusion. This retrospective study identified the characteristics of those likely to require transfusions. Blood conservation strategies seem to decrease the need for transfusions. The hospitalists played an important role in implementing the BCG. A prospective controlled study with adequate power is needed to examine both the various mechanisms for developing anemia and the impact of the individual components of the blood conservation strategies.
- ,.Thoracic empyema.Surg Clin North Am.2002;82:643–671.
- ,.Parapneumonic Pleural effusion and empyema in children: review of 19 year experience.Clin Pediatr (Phila).1983;22:414–419.
- American Thoracic Society.Management of nontuberculosis empyema.Am Rev Respir Dis.1962;85:935–936.
- ,,, et al.Short‐term course and outcome of treatments of pleural empyema in pediatric patients: repeated ultrasound‐guided needle thoracentesis vs. chest tube drainage.Chest.2002;121:836–840.
- ,,, et al.Randomized trial of Intrapleural Urokinase in the treatment of childhood empyema.Thorax.2002;57:343–347.
- ,,,,.Therapy of parapneumonic effusion in children: video‐assisted thoracoscopic surgery versus conventional thoracostomy drainage.Pediatrics.2006;118:e547–e553.
- ,,,.Is open thoracotomy still a good treatment option for the management of Empyema in children?Ann Thorac Surg.2003;76:1854–1858.
- ,,, et al.Anemia, blood loss, and blood transfusions in North American children in the intensive care unit.Am J Respir Crit Care Med.2008;178:25–33.
- .Medical vampires.N Engl J Med.1983;314:1250–1251.
- ,,, et al.Important role of nondiagnostic blood loss and blunted erythropoietic response in the anemia of medical intensive care patients.Crit Care Med.1999;27:2630–2639.
- ,,, et al.Erythropoietin response is blunted in critically ill patients.Intensive Care Med.1997;23:159–162.
- ,.The continuing risk of transfusion‐transmitted infections.N Engl J Med.2006;355:1303–1305.
- ,.Immunomodulation by blood transfusion: an evolving scientific and clinical challenge.Am J Med.1996;101:299–308.
- ,,,.Pediatric red blood cell transfusions increase resource use.J Pediatr.2003;142:95–97.
- ,.Effect of blood transfusion on oxygen consumption in pediatric septic shock.Crit Care Med.1990;18:1087–1091.
- ,,,,.Red blood cell transfusion in critically ill children is independently associated with increased mortality.Intensive Care Med.2007;33:1414–1422.
- ,,.PRISM III: an updated pediatric risk of mortality.Crit Care Med.1996;24(5):743–752.
- ,,, et al.Transfusion strategies for patients in pediatric intensive care units.Nw Engl J Med.2007;356:1609–1619.
- ,,, et al.Efficacy of recombinant human erythropoietin in critically ill patients.JAMA.2002;288:2827–2835.
- ,,, et al.EPO Critical Care Trials Group.Efficacy and safety of epoetin alfa in criticall ill patients.Nw Engl J Med.2007;357:965–976.
- ,,.Erythropoietin therapy in children with Bronchiolitis and anemia.Pediatr Crit Care Med.2003;4(1):44–47.
- .The state of hospital medicine in 2008.Med Clin North Am.2008;92:265–273.
- ,,, et al.Impact of a Hospitalist system on length of stay and cost for children with common conditions.Pediatrics.2007;120:267–274.
- ,,,.Comparison of hospitalists and nonhospitalists regarding core measures of pneumonia care.Am J Manag Care.2007;13:129–132.
- ,,.Improved survival with hospitalists in a pediatric intensive care unit.Crit Care Med.2003;31:847–852.
- ,.Thoracic empyema.Surg Clin North Am.2002;82:643–671.
- ,.Parapneumonic Pleural effusion and empyema in children: review of 19 year experience.Clin Pediatr (Phila).1983;22:414–419.
- American Thoracic Society.Management of nontuberculosis empyema.Am Rev Respir Dis.1962;85:935–936.
- ,,, et al.Short‐term course and outcome of treatments of pleural empyema in pediatric patients: repeated ultrasound‐guided needle thoracentesis vs. chest tube drainage.Chest.2002;121:836–840.
- ,,, et al.Randomized trial of Intrapleural Urokinase in the treatment of childhood empyema.Thorax.2002;57:343–347.
- ,,,,.Therapy of parapneumonic effusion in children: video‐assisted thoracoscopic surgery versus conventional thoracostomy drainage.Pediatrics.2006;118:e547–e553.
- ,,,.Is open thoracotomy still a good treatment option for the management of Empyema in children?Ann Thorac Surg.2003;76:1854–1858.
- ,,, et al.Anemia, blood loss, and blood transfusions in North American children in the intensive care unit.Am J Respir Crit Care Med.2008;178:25–33.
- .Medical vampires.N Engl J Med.1983;314:1250–1251.
- ,,, et al.Important role of nondiagnostic blood loss and blunted erythropoietic response in the anemia of medical intensive care patients.Crit Care Med.1999;27:2630–2639.
- ,,, et al.Erythropoietin response is blunted in critically ill patients.Intensive Care Med.1997;23:159–162.
- ,.The continuing risk of transfusion‐transmitted infections.N Engl J Med.2006;355:1303–1305.
- ,.Immunomodulation by blood transfusion: an evolving scientific and clinical challenge.Am J Med.1996;101:299–308.
- ,,,.Pediatric red blood cell transfusions increase resource use.J Pediatr.2003;142:95–97.
- ,.Effect of blood transfusion on oxygen consumption in pediatric septic shock.Crit Care Med.1990;18:1087–1091.
- ,,,,.Red blood cell transfusion in critically ill children is independently associated with increased mortality.Intensive Care Med.2007;33:1414–1422.
- ,,.PRISM III: an updated pediatric risk of mortality.Crit Care Med.1996;24(5):743–752.
- ,,, et al.Transfusion strategies for patients in pediatric intensive care units.Nw Engl J Med.2007;356:1609–1619.
- ,,, et al.Efficacy of recombinant human erythropoietin in critically ill patients.JAMA.2002;288:2827–2835.
- ,,, et al.EPO Critical Care Trials Group.Efficacy and safety of epoetin alfa in criticall ill patients.Nw Engl J Med.2007;357:965–976.
- ,,.Erythropoietin therapy in children with Bronchiolitis and anemia.Pediatr Crit Care Med.2003;4(1):44–47.
- .The state of hospital medicine in 2008.Med Clin North Am.2008;92:265–273.
- ,,, et al.Impact of a Hospitalist system on length of stay and cost for children with common conditions.Pediatrics.2007;120:267–274.
- ,,,.Comparison of hospitalists and nonhospitalists regarding core measures of pneumonia care.Am J Manag Care.2007;13:129–132.
- ,,.Improved survival with hospitalists in a pediatric intensive care unit.Crit Care Med.2003;31:847–852.
Copyright © 2010 Society of Hospital Medicine
Cold case: Bedside diagnosis of Mycoplasma pneumonia
A 35‐year‐old woman with no past medical history presented to the Emergency Department (ED) with 3 weeks of worsening cough and shortness of breath. Two weeks prior to her presentation she was seen by her primary care physician for flu‐like symptoms, including myalgias, subjective fevers, nonproductive cough, and malaise. She was told that her symptoms were attributable to influenza, and she was treated supportively; however, her symptoms progressed, and she was referred to the ED for further care. Of note, she reported recent cross‐continental air travel as well as an upper respiratory illness in her young child.
On physical exam she was afebrile with normal vital signs and normal room air oxygen saturation. Her oropharynx was clear, and she had no sinus tenderness, rashes, joint swelling, or palpable lymphadenopathy. She was in moderate respiratory distress and had inspiratory crackles at both lung bases.
Complete blood count, electrolytes, and electrocardiogram (ECG) were within normal limits. A D‐dimer level was slightly elevated. Chest X‐ray showed a mild hazy opacity at the right lung base (Figure 1). Computed tomography (CT) angiography of the chest showed bilateral lower lobe infiltrates (Figure 2) but no pulmonary emboli.
A bedside cold agglutinin test, in which the patients blood is drawn into an ethylene diamine tetraacetic acid (EDTA) tube and placed on ice for 30 seconds to 60 seconds, was positive for grains of sand, suggestive of high titers of Mycoplasma pneumoniae immunoglobulin M (IgM) (Figure 3). The patient was discharged with oral antibiotics and reported marked symptomatic relief within 2 days.
The utility of culture and serology for acute diagnosis of M. pneumoniae infection is limited. Cold agglutinins are antibodiesmost commonly IgMthat cross‐react with red blood cell antigens. They develop in 50% to 75% of patients 1 week to 2 weeks following initial exposure to M. pneumoniae and their incidence decreases with age. Within the clinical context of community‐acquired pneumonia, a bedside cold agglutinin test is specific for M. pneumoniae and provides a rapid and inexpensive means for confirming a suspected diagnosis.
A 35‐year‐old woman with no past medical history presented to the Emergency Department (ED) with 3 weeks of worsening cough and shortness of breath. Two weeks prior to her presentation she was seen by her primary care physician for flu‐like symptoms, including myalgias, subjective fevers, nonproductive cough, and malaise. She was told that her symptoms were attributable to influenza, and she was treated supportively; however, her symptoms progressed, and she was referred to the ED for further care. Of note, she reported recent cross‐continental air travel as well as an upper respiratory illness in her young child.
On physical exam she was afebrile with normal vital signs and normal room air oxygen saturation. Her oropharynx was clear, and she had no sinus tenderness, rashes, joint swelling, or palpable lymphadenopathy. She was in moderate respiratory distress and had inspiratory crackles at both lung bases.
Complete blood count, electrolytes, and electrocardiogram (ECG) were within normal limits. A D‐dimer level was slightly elevated. Chest X‐ray showed a mild hazy opacity at the right lung base (Figure 1). Computed tomography (CT) angiography of the chest showed bilateral lower lobe infiltrates (Figure 2) but no pulmonary emboli.
A bedside cold agglutinin test, in which the patients blood is drawn into an ethylene diamine tetraacetic acid (EDTA) tube and placed on ice for 30 seconds to 60 seconds, was positive for grains of sand, suggestive of high titers of Mycoplasma pneumoniae immunoglobulin M (IgM) (Figure 3). The patient was discharged with oral antibiotics and reported marked symptomatic relief within 2 days.
The utility of culture and serology for acute diagnosis of M. pneumoniae infection is limited. Cold agglutinins are antibodiesmost commonly IgMthat cross‐react with red blood cell antigens. They develop in 50% to 75% of patients 1 week to 2 weeks following initial exposure to M. pneumoniae and their incidence decreases with age. Within the clinical context of community‐acquired pneumonia, a bedside cold agglutinin test is specific for M. pneumoniae and provides a rapid and inexpensive means for confirming a suspected diagnosis.
A 35‐year‐old woman with no past medical history presented to the Emergency Department (ED) with 3 weeks of worsening cough and shortness of breath. Two weeks prior to her presentation she was seen by her primary care physician for flu‐like symptoms, including myalgias, subjective fevers, nonproductive cough, and malaise. She was told that her symptoms were attributable to influenza, and she was treated supportively; however, her symptoms progressed, and she was referred to the ED for further care. Of note, she reported recent cross‐continental air travel as well as an upper respiratory illness in her young child.
On physical exam she was afebrile with normal vital signs and normal room air oxygen saturation. Her oropharynx was clear, and she had no sinus tenderness, rashes, joint swelling, or palpable lymphadenopathy. She was in moderate respiratory distress and had inspiratory crackles at both lung bases.
Complete blood count, electrolytes, and electrocardiogram (ECG) were within normal limits. A D‐dimer level was slightly elevated. Chest X‐ray showed a mild hazy opacity at the right lung base (Figure 1). Computed tomography (CT) angiography of the chest showed bilateral lower lobe infiltrates (Figure 2) but no pulmonary emboli.
A bedside cold agglutinin test, in which the patients blood is drawn into an ethylene diamine tetraacetic acid (EDTA) tube and placed on ice for 30 seconds to 60 seconds, was positive for grains of sand, suggestive of high titers of Mycoplasma pneumoniae immunoglobulin M (IgM) (Figure 3). The patient was discharged with oral antibiotics and reported marked symptomatic relief within 2 days.
The utility of culture and serology for acute diagnosis of M. pneumoniae infection is limited. Cold agglutinins are antibodiesmost commonly IgMthat cross‐react with red blood cell antigens. They develop in 50% to 75% of patients 1 week to 2 weeks following initial exposure to M. pneumoniae and their incidence decreases with age. Within the clinical context of community‐acquired pneumonia, a bedside cold agglutinin test is specific for M. pneumoniae and provides a rapid and inexpensive means for confirming a suspected diagnosis.
A Small Kindness
On August 6, 2009, my vigorously healthy 59‐year‐old brother‐in‐law, a beloved husband and father of 2 sons, developed mild right hand clumsiness and slight slurring of speech. This led to a primary care visit and the symptoms were originally felt to be related to working long hours and stress. The symptoms failed to improve and on August 11th, an magnetic resonance imaging (MRI) made a shocking discovery, my brother‐in‐law had a brain tumor. He was seen in the Neurosurgery department of a major academic center the following day and on August 13th he underwent resection of the majority of the tumor with a pathologic finding of grade IV glioblastoma multiforme (GBM).
During this initial admission, a consultation was obtained from a neuro‐oncologist who would then become the principle director of his care. My brother‐in‐law was crystal clear with his physicians; he wanted honest information about what to expect. From the outset he understood this was an incurable disease, but hoped that with aggressive treatment, he could live for months, possibly even years. He started chemotherapy almost immediately and in early October started a 6‐week course of daily radiation. The early weeks went relatively well. He saw his oncologist regularly and stayed in close contact with his oncology nurse. With his engineering background and attention to details, he followed his physician's instructions to the letter; however, despite his very best efforts at compliance and working intensively with physical therapy he was becoming progressively weaker.
In early November, a follow‐up MRI appeared to show progression of tumor and on November 12th, a second resection was undertaken. Pathologically, this seemed successful with removal of tumor bulk, but he was left even weaker, particularly on the right side. His symptoms were managed with dexamethasone; however, aphasia and hemiparesis would always reemerge with attempts to taper the drug and his functional status was too poor to allow for further chemotherapy. As his communication ability was becoming more limited, my sister‐in‐law was increasingly becoming his spokesperson at doctor visits and with phone updates to his oncology nurse.
On January 21, 2010 after working with a home physical therapist, he was making a transfer and became nonresponsive. Paramedics were called, arriving within minutes, but he was found pulseless. Despite a heroic resuscitative effort, he was pronounced dead at a nearby hospital a short time thereafter. A postmortem was not performed and the presumptive cause of death was pulmonary embolism.
His funeral was January 29th.
My brother‐in‐law and I lived 1600 miles apart and saw each other on only the rarest occasions. When the diagnosis was made, my role changed as I am the only relative within the extended family with medical expertise. Questions were directed to me via e‐mails and I did my best using UpToDate and other resources to learn about GBM and relay this information back to the family.
Recently, and in a vicarious way, I was becoming more and more deeply involved. Using the best descriptions of functional status that I could extract from e‐mail and phone calls, I estimated his Karnofsky Performance Score as being fairly poor. By way of my e‐mails to him and his wife, I was just beginning, ever so gently, to touch on the subject of hospice care at the time of his sudden death.
At the visitation and reception following the funeral, I think I was seen as more than a distant brother‐in‐law; I was also seen as a surrogate for the medical profession and for his doctors in particular. One message that I got loud and clear, from more than 1 family member was the devastated, abandoned feeling that was emerging in the 8 days since his death. On the morning following his death, my sister‐in‐law called his physician's office and told his oncology nurse that her husband had died suddenly and unexpectedly the night before. The nurse expressed sympathy and indicated she would relay this information to his doctor and she would personally call back. As of the time I left to return home, that was the last communication any family member had received from anyone involved in his care.
Although the outpouring of community support and sympathy was powerful and touching, not a single condolence card or phone call came from his doctor. I was shocked at the suddenness of his death, but I was also shocked at the complete absence of any communication, any acknowledgement of his courageous struggle against a terrible illness, or of his family's depth of caring and love over these last few months.
I am reminded of an essay by Gregory Kane, MD in CHEST,1 in which he describes a disturbing personal encounter with the following;
In a personal and memorable patient encounter, I sat and listened while a tearful patient cried at having received no contact from the physician who treated her husband for metastatic lung cancer for a treatment duration of 9 months. As I struggled to comprehend her sense of pain and abandonment, I considered offering as possible explanation that the physician may not have been on call at the time of the death and may have mistakenly believed that his partner had offered such a gesture verbally. Before I could respond, however, my patient added that her veterinarian had sent a card when the family dog died. I was speechless.1
As Hospitalists, we are gifted and privileged to work closely with patients and their loved ones struggling with the existential and eternal questions of life and death. As we can all well attest from 6 PM family meetings, the unit‐of‐care extends beyond the patient and certainly includes the loving and caring members of the patient's family and close support system. If we fail to acknowledge a family's bereavement, we run the risk of unintentionally communicating the message that the patient was not important, that their suffering did not matter or that the crushing grief the family may be bearing is somehow insignificant compared to our busy schedules.
I have asked you to join me on this short journey my brother‐in‐law has taken these last few months in the interest of raising awareness. There are many occasions when a verbal, bedside expression of condolence is very appropriate and completely adequate. There are other times when a condolence letter will better facilitate the closure of the physician‐patient‐family relationship. This may be intimidating, both the extra work involved and especially the challenge of not knowing what to say. The article quoted above by Dr. Kane is an excellent resource for guidance concerning content, style, and other writing considerations. Using examples, such as a letter from Abraham Lincoln to a girl whose father died in the Civil War, he shows that this essential communication does not have to be lengthy or difficult. Another excellent resource can be found in the New England Journal of Medicine; The Doctor's Letter of Condolence.2 See Table 1 for suggestions to help with bereavement communications.
| Handwritten on a card or stationary. |
| Timely (within 1‐2 weeks of death). |
| Use sensitive, caring language and avoid clich. |
| Acknowledge the family's grief and loss. |
| Acknowledge the patient's courage or other qualities. |
| Mention the privilege it has been to work with the patient. |
| Mention your appreciation of the family's caring. |
| Avoid sincerely yours and end on a personal note such as suggesting your thoughts are with them at this most difficult time. |
We are the profession of Hospital Medicine. It is our knowledge, our hope, our compassion, our experience and judgment that often directs care at the end‐of‐life for many of our patients. We are teammates along with the primary care provider, subspecialty consultants, palliative care specialists and other members of the care team. We have a professional obligation to extend a thoughtful condolence to surviving family members and to contact other members of the care team so that they too may have this opportunity. The responsibility for the final closure rests with us and within this responsibility is a powerful fulfillment of the promise of the practice of medicine.
The condolence note is a small kindness, a part of the art of medicine, a part of our humanness and essential to our vision of patient‐centered hospital care.
- .A Dying Art?: The Doctor's Letter of Condolence.Chest.2007;131(4):1245–1247. Permission for use obtained by direct communication with the author on January 31, 2010.
- ,,.The doctor's letter of condolence.N Engl J Med.2001;344(15):1162–1163.
On August 6, 2009, my vigorously healthy 59‐year‐old brother‐in‐law, a beloved husband and father of 2 sons, developed mild right hand clumsiness and slight slurring of speech. This led to a primary care visit and the symptoms were originally felt to be related to working long hours and stress. The symptoms failed to improve and on August 11th, an magnetic resonance imaging (MRI) made a shocking discovery, my brother‐in‐law had a brain tumor. He was seen in the Neurosurgery department of a major academic center the following day and on August 13th he underwent resection of the majority of the tumor with a pathologic finding of grade IV glioblastoma multiforme (GBM).
During this initial admission, a consultation was obtained from a neuro‐oncologist who would then become the principle director of his care. My brother‐in‐law was crystal clear with his physicians; he wanted honest information about what to expect. From the outset he understood this was an incurable disease, but hoped that with aggressive treatment, he could live for months, possibly even years. He started chemotherapy almost immediately and in early October started a 6‐week course of daily radiation. The early weeks went relatively well. He saw his oncologist regularly and stayed in close contact with his oncology nurse. With his engineering background and attention to details, he followed his physician's instructions to the letter; however, despite his very best efforts at compliance and working intensively with physical therapy he was becoming progressively weaker.
In early November, a follow‐up MRI appeared to show progression of tumor and on November 12th, a second resection was undertaken. Pathologically, this seemed successful with removal of tumor bulk, but he was left even weaker, particularly on the right side. His symptoms were managed with dexamethasone; however, aphasia and hemiparesis would always reemerge with attempts to taper the drug and his functional status was too poor to allow for further chemotherapy. As his communication ability was becoming more limited, my sister‐in‐law was increasingly becoming his spokesperson at doctor visits and with phone updates to his oncology nurse.
On January 21, 2010 after working with a home physical therapist, he was making a transfer and became nonresponsive. Paramedics were called, arriving within minutes, but he was found pulseless. Despite a heroic resuscitative effort, he was pronounced dead at a nearby hospital a short time thereafter. A postmortem was not performed and the presumptive cause of death was pulmonary embolism.
His funeral was January 29th.
My brother‐in‐law and I lived 1600 miles apart and saw each other on only the rarest occasions. When the diagnosis was made, my role changed as I am the only relative within the extended family with medical expertise. Questions were directed to me via e‐mails and I did my best using UpToDate and other resources to learn about GBM and relay this information back to the family.
Recently, and in a vicarious way, I was becoming more and more deeply involved. Using the best descriptions of functional status that I could extract from e‐mail and phone calls, I estimated his Karnofsky Performance Score as being fairly poor. By way of my e‐mails to him and his wife, I was just beginning, ever so gently, to touch on the subject of hospice care at the time of his sudden death.
At the visitation and reception following the funeral, I think I was seen as more than a distant brother‐in‐law; I was also seen as a surrogate for the medical profession and for his doctors in particular. One message that I got loud and clear, from more than 1 family member was the devastated, abandoned feeling that was emerging in the 8 days since his death. On the morning following his death, my sister‐in‐law called his physician's office and told his oncology nurse that her husband had died suddenly and unexpectedly the night before. The nurse expressed sympathy and indicated she would relay this information to his doctor and she would personally call back. As of the time I left to return home, that was the last communication any family member had received from anyone involved in his care.
Although the outpouring of community support and sympathy was powerful and touching, not a single condolence card or phone call came from his doctor. I was shocked at the suddenness of his death, but I was also shocked at the complete absence of any communication, any acknowledgement of his courageous struggle against a terrible illness, or of his family's depth of caring and love over these last few months.
I am reminded of an essay by Gregory Kane, MD in CHEST,1 in which he describes a disturbing personal encounter with the following;
In a personal and memorable patient encounter, I sat and listened while a tearful patient cried at having received no contact from the physician who treated her husband for metastatic lung cancer for a treatment duration of 9 months. As I struggled to comprehend her sense of pain and abandonment, I considered offering as possible explanation that the physician may not have been on call at the time of the death and may have mistakenly believed that his partner had offered such a gesture verbally. Before I could respond, however, my patient added that her veterinarian had sent a card when the family dog died. I was speechless.1
As Hospitalists, we are gifted and privileged to work closely with patients and their loved ones struggling with the existential and eternal questions of life and death. As we can all well attest from 6 PM family meetings, the unit‐of‐care extends beyond the patient and certainly includes the loving and caring members of the patient's family and close support system. If we fail to acknowledge a family's bereavement, we run the risk of unintentionally communicating the message that the patient was not important, that their suffering did not matter or that the crushing grief the family may be bearing is somehow insignificant compared to our busy schedules.
I have asked you to join me on this short journey my brother‐in‐law has taken these last few months in the interest of raising awareness. There are many occasions when a verbal, bedside expression of condolence is very appropriate and completely adequate. There are other times when a condolence letter will better facilitate the closure of the physician‐patient‐family relationship. This may be intimidating, both the extra work involved and especially the challenge of not knowing what to say. The article quoted above by Dr. Kane is an excellent resource for guidance concerning content, style, and other writing considerations. Using examples, such as a letter from Abraham Lincoln to a girl whose father died in the Civil War, he shows that this essential communication does not have to be lengthy or difficult. Another excellent resource can be found in the New England Journal of Medicine; The Doctor's Letter of Condolence.2 See Table 1 for suggestions to help with bereavement communications.
| Handwritten on a card or stationary. |
| Timely (within 1‐2 weeks of death). |
| Use sensitive, caring language and avoid clich. |
| Acknowledge the family's grief and loss. |
| Acknowledge the patient's courage or other qualities. |
| Mention the privilege it has been to work with the patient. |
| Mention your appreciation of the family's caring. |
| Avoid sincerely yours and end on a personal note such as suggesting your thoughts are with them at this most difficult time. |
We are the profession of Hospital Medicine. It is our knowledge, our hope, our compassion, our experience and judgment that often directs care at the end‐of‐life for many of our patients. We are teammates along with the primary care provider, subspecialty consultants, palliative care specialists and other members of the care team. We have a professional obligation to extend a thoughtful condolence to surviving family members and to contact other members of the care team so that they too may have this opportunity. The responsibility for the final closure rests with us and within this responsibility is a powerful fulfillment of the promise of the practice of medicine.
The condolence note is a small kindness, a part of the art of medicine, a part of our humanness and essential to our vision of patient‐centered hospital care.
On August 6, 2009, my vigorously healthy 59‐year‐old brother‐in‐law, a beloved husband and father of 2 sons, developed mild right hand clumsiness and slight slurring of speech. This led to a primary care visit and the symptoms were originally felt to be related to working long hours and stress. The symptoms failed to improve and on August 11th, an magnetic resonance imaging (MRI) made a shocking discovery, my brother‐in‐law had a brain tumor. He was seen in the Neurosurgery department of a major academic center the following day and on August 13th he underwent resection of the majority of the tumor with a pathologic finding of grade IV glioblastoma multiforme (GBM).
During this initial admission, a consultation was obtained from a neuro‐oncologist who would then become the principle director of his care. My brother‐in‐law was crystal clear with his physicians; he wanted honest information about what to expect. From the outset he understood this was an incurable disease, but hoped that with aggressive treatment, he could live for months, possibly even years. He started chemotherapy almost immediately and in early October started a 6‐week course of daily radiation. The early weeks went relatively well. He saw his oncologist regularly and stayed in close contact with his oncology nurse. With his engineering background and attention to details, he followed his physician's instructions to the letter; however, despite his very best efforts at compliance and working intensively with physical therapy he was becoming progressively weaker.
In early November, a follow‐up MRI appeared to show progression of tumor and on November 12th, a second resection was undertaken. Pathologically, this seemed successful with removal of tumor bulk, but he was left even weaker, particularly on the right side. His symptoms were managed with dexamethasone; however, aphasia and hemiparesis would always reemerge with attempts to taper the drug and his functional status was too poor to allow for further chemotherapy. As his communication ability was becoming more limited, my sister‐in‐law was increasingly becoming his spokesperson at doctor visits and with phone updates to his oncology nurse.
On January 21, 2010 after working with a home physical therapist, he was making a transfer and became nonresponsive. Paramedics were called, arriving within minutes, but he was found pulseless. Despite a heroic resuscitative effort, he was pronounced dead at a nearby hospital a short time thereafter. A postmortem was not performed and the presumptive cause of death was pulmonary embolism.
His funeral was January 29th.
My brother‐in‐law and I lived 1600 miles apart and saw each other on only the rarest occasions. When the diagnosis was made, my role changed as I am the only relative within the extended family with medical expertise. Questions were directed to me via e‐mails and I did my best using UpToDate and other resources to learn about GBM and relay this information back to the family.
Recently, and in a vicarious way, I was becoming more and more deeply involved. Using the best descriptions of functional status that I could extract from e‐mail and phone calls, I estimated his Karnofsky Performance Score as being fairly poor. By way of my e‐mails to him and his wife, I was just beginning, ever so gently, to touch on the subject of hospice care at the time of his sudden death.
At the visitation and reception following the funeral, I think I was seen as more than a distant brother‐in‐law; I was also seen as a surrogate for the medical profession and for his doctors in particular. One message that I got loud and clear, from more than 1 family member was the devastated, abandoned feeling that was emerging in the 8 days since his death. On the morning following his death, my sister‐in‐law called his physician's office and told his oncology nurse that her husband had died suddenly and unexpectedly the night before. The nurse expressed sympathy and indicated she would relay this information to his doctor and she would personally call back. As of the time I left to return home, that was the last communication any family member had received from anyone involved in his care.
Although the outpouring of community support and sympathy was powerful and touching, not a single condolence card or phone call came from his doctor. I was shocked at the suddenness of his death, but I was also shocked at the complete absence of any communication, any acknowledgement of his courageous struggle against a terrible illness, or of his family's depth of caring and love over these last few months.
I am reminded of an essay by Gregory Kane, MD in CHEST,1 in which he describes a disturbing personal encounter with the following;
In a personal and memorable patient encounter, I sat and listened while a tearful patient cried at having received no contact from the physician who treated her husband for metastatic lung cancer for a treatment duration of 9 months. As I struggled to comprehend her sense of pain and abandonment, I considered offering as possible explanation that the physician may not have been on call at the time of the death and may have mistakenly believed that his partner had offered such a gesture verbally. Before I could respond, however, my patient added that her veterinarian had sent a card when the family dog died. I was speechless.1
As Hospitalists, we are gifted and privileged to work closely with patients and their loved ones struggling with the existential and eternal questions of life and death. As we can all well attest from 6 PM family meetings, the unit‐of‐care extends beyond the patient and certainly includes the loving and caring members of the patient's family and close support system. If we fail to acknowledge a family's bereavement, we run the risk of unintentionally communicating the message that the patient was not important, that their suffering did not matter or that the crushing grief the family may be bearing is somehow insignificant compared to our busy schedules.
I have asked you to join me on this short journey my brother‐in‐law has taken these last few months in the interest of raising awareness. There are many occasions when a verbal, bedside expression of condolence is very appropriate and completely adequate. There are other times when a condolence letter will better facilitate the closure of the physician‐patient‐family relationship. This may be intimidating, both the extra work involved and especially the challenge of not knowing what to say. The article quoted above by Dr. Kane is an excellent resource for guidance concerning content, style, and other writing considerations. Using examples, such as a letter from Abraham Lincoln to a girl whose father died in the Civil War, he shows that this essential communication does not have to be lengthy or difficult. Another excellent resource can be found in the New England Journal of Medicine; The Doctor's Letter of Condolence.2 See Table 1 for suggestions to help with bereavement communications.
| Handwritten on a card or stationary. |
| Timely (within 1‐2 weeks of death). |
| Use sensitive, caring language and avoid clich. |
| Acknowledge the family's grief and loss. |
| Acknowledge the patient's courage or other qualities. |
| Mention the privilege it has been to work with the patient. |
| Mention your appreciation of the family's caring. |
| Avoid sincerely yours and end on a personal note such as suggesting your thoughts are with them at this most difficult time. |
We are the profession of Hospital Medicine. It is our knowledge, our hope, our compassion, our experience and judgment that often directs care at the end‐of‐life for many of our patients. We are teammates along with the primary care provider, subspecialty consultants, palliative care specialists and other members of the care team. We have a professional obligation to extend a thoughtful condolence to surviving family members and to contact other members of the care team so that they too may have this opportunity. The responsibility for the final closure rests with us and within this responsibility is a powerful fulfillment of the promise of the practice of medicine.
The condolence note is a small kindness, a part of the art of medicine, a part of our humanness and essential to our vision of patient‐centered hospital care.
- .A Dying Art?: The Doctor's Letter of Condolence.Chest.2007;131(4):1245–1247. Permission for use obtained by direct communication with the author on January 31, 2010.
- ,,.The doctor's letter of condolence.N Engl J Med.2001;344(15):1162–1163.
- .A Dying Art?: The Doctor's Letter of Condolence.Chest.2007;131(4):1245–1247. Permission for use obtained by direct communication with the author on January 31, 2010.
- ,,.The doctor's letter of condolence.N Engl J Med.2001;344(15):1162–1163.
Band-Aids Won't Fix Medicare Payment Problems
July 1 marked the debut of several features in this year’s healthcare reform legislation, including the acceptance of uninsured applicants to high-risk insurance pools. For many hospitalists and other doctors, however, the new arrivals only heightened their disappointment over the legislation’s lost opportunity: a permanent fix to the flawed sustainable growth rate, or SGR, that dictates Medicare reimbursements.
“It should have been taken care of in that bill,” says Ron Greeno, MD, SFHM, a member of SHM’s Public Policy Committee and CMO of Brentwood, Tenn.-based Cogent Healthcare. “Obviously, there’s a lot of frustration around the issue, especially on the membership side.”
June provided a stark reminder of the potential for catastrophe should the annual rate cuts to Medicare reimbursements to physicians—21.3% to date—ever go into effect. Congress eventually pushed through yet another temporary fix, delaying any cut from June 1 until Dec. 1 (after the midterm elections, of course) and even tacking on a 2.2% increase. But the House didn’t pass the extension until June 24, nearly a week after the Centers for Medicare & Medicaid Services (CMS) began processing June claims at the lower rate.
By that point, some doctors had begun refusing to see Medicare patients. Both doctors and hospitals have since had to resubmit some June claims to gain the full value, creating new headaches and expenses over the additional paperwork. “It’s wreaking havoc on the provider community,” Dr. Greeno says. “The uncertainty that has been created around these short-term fixes is very disquieting.”
Doctors and hospitals have had to resubmit some June claims to gain the full value, creating expenses over the additional paperwork. And then, of course, there’s the new Nov. 30 deadline facing a lame-duck Congress. As politicians continue dithering over a permanent fix and an accompanying price tag of $250 billion or more over a decade, CMS has announced next year’s rate cut. With a 6.1% decrease slated to take effect on Jan. 1, 2011, the combined SGR-mandated drop would reach nearly 30%. Ouch.
Find out the latest information on SGR reform and contact your legislators in support of permanent repeal through SHM's Legislative Action Center.
July 1 marked the debut of several features in this year’s healthcare reform legislation, including the acceptance of uninsured applicants to high-risk insurance pools. For many hospitalists and other doctors, however, the new arrivals only heightened their disappointment over the legislation’s lost opportunity: a permanent fix to the flawed sustainable growth rate, or SGR, that dictates Medicare reimbursements.
“It should have been taken care of in that bill,” says Ron Greeno, MD, SFHM, a member of SHM’s Public Policy Committee and CMO of Brentwood, Tenn.-based Cogent Healthcare. “Obviously, there’s a lot of frustration around the issue, especially on the membership side.”
June provided a stark reminder of the potential for catastrophe should the annual rate cuts to Medicare reimbursements to physicians—21.3% to date—ever go into effect. Congress eventually pushed through yet another temporary fix, delaying any cut from June 1 until Dec. 1 (after the midterm elections, of course) and even tacking on a 2.2% increase. But the House didn’t pass the extension until June 24, nearly a week after the Centers for Medicare & Medicaid Services (CMS) began processing June claims at the lower rate.
By that point, some doctors had begun refusing to see Medicare patients. Both doctors and hospitals have since had to resubmit some June claims to gain the full value, creating new headaches and expenses over the additional paperwork. “It’s wreaking havoc on the provider community,” Dr. Greeno says. “The uncertainty that has been created around these short-term fixes is very disquieting.”
Doctors and hospitals have had to resubmit some June claims to gain the full value, creating expenses over the additional paperwork. And then, of course, there’s the new Nov. 30 deadline facing a lame-duck Congress. As politicians continue dithering over a permanent fix and an accompanying price tag of $250 billion or more over a decade, CMS has announced next year’s rate cut. With a 6.1% decrease slated to take effect on Jan. 1, 2011, the combined SGR-mandated drop would reach nearly 30%. Ouch.
Find out the latest information on SGR reform and contact your legislators in support of permanent repeal through SHM's Legislative Action Center.
July 1 marked the debut of several features in this year’s healthcare reform legislation, including the acceptance of uninsured applicants to high-risk insurance pools. For many hospitalists and other doctors, however, the new arrivals only heightened their disappointment over the legislation’s lost opportunity: a permanent fix to the flawed sustainable growth rate, or SGR, that dictates Medicare reimbursements.
“It should have been taken care of in that bill,” says Ron Greeno, MD, SFHM, a member of SHM’s Public Policy Committee and CMO of Brentwood, Tenn.-based Cogent Healthcare. “Obviously, there’s a lot of frustration around the issue, especially on the membership side.”
June provided a stark reminder of the potential for catastrophe should the annual rate cuts to Medicare reimbursements to physicians—21.3% to date—ever go into effect. Congress eventually pushed through yet another temporary fix, delaying any cut from June 1 until Dec. 1 (after the midterm elections, of course) and even tacking on a 2.2% increase. But the House didn’t pass the extension until June 24, nearly a week after the Centers for Medicare & Medicaid Services (CMS) began processing June claims at the lower rate.
By that point, some doctors had begun refusing to see Medicare patients. Both doctors and hospitals have since had to resubmit some June claims to gain the full value, creating new headaches and expenses over the additional paperwork. “It’s wreaking havoc on the provider community,” Dr. Greeno says. “The uncertainty that has been created around these short-term fixes is very disquieting.”
Doctors and hospitals have had to resubmit some June claims to gain the full value, creating expenses over the additional paperwork. And then, of course, there’s the new Nov. 30 deadline facing a lame-duck Congress. As politicians continue dithering over a permanent fix and an accompanying price tag of $250 billion or more over a decade, CMS has announced next year’s rate cut. With a 6.1% decrease slated to take effect on Jan. 1, 2011, the combined SGR-mandated drop would reach nearly 30%. Ouch.
Find out the latest information on SGR reform and contact your legislators in support of permanent repeal through SHM's Legislative Action Center.
Handoffs Smoother in Rural Communities
Before Matthew Schreiber, MD, became chief medical officer of Piedmont Hospital in Atlanta, he was director of hospitalist services for the four-hospital Piedmont health system, and before that, a hospitalist for the system’s smallest hospital, 35-bed Piedmont Mountainside in Jasper, Ga., population 2,000, so he knows just how different transitions of care are between hospitals large and small.
In many rural communities, the hospitalist concept has only recently been introduced, and patients are accustomed to PCPs being responsible for all of their medical care. But it can be easier to achieve high-quality handoffs in rural areas because the number of physicians involved is much smaller, Dr. Schreiber says.
“At Piedmont Mountainside, only eight physicians made most of our referrals. It was possible to memorize their office numbers and their call-coverage arrangements,” he explains. Some doctors are accessible 24 hours, seven days a week, while others take their patients’ charts home overnight in case they get called. This encourages an individualized approach to communicating with them. “It makes the care feel more personal, with a different level of accountability,” Dr. Schreiber says. “You feel a connection to the patient and the doctor—and that your job isn’t done when the patient goes home.”
Rural hospitals and doctors also tend to have closer relationships with community services like home health agencies. “We can give the medication list to the home health nurse and say, ‘This is what we think the patient is taking. We want you to go in and find out what they’re actually taking and reconcile the two,’ ” Dr. Schreiber says.
However, small and rural hospitals—particularly stand-alone and critical access facilities—are less likely to have computerized tools for automating and facilitating care transitions, Dr. Schreiber says. In some cases, the rural hospitalist carries a pager and takes calls 24/7.
Dr. Schreiber says it’s important to hand patients a piece of paper that summarizes their condition, key events in the hospitalization, and new medications, all in patient-friendly language, to take home and post on the refrigerator. “In our experience, patients hold onto this document and bring it to the doctor’s office or even to the emergency room,” he says, adding that if the formal discharge summary doesn’t reach the PCP in time, this summary could be a godsend.
Visit our website for more information about local and national efforts to improve care transitions.
Check out the SHM website for information on Project BOOST (Better Outcomes for Older Adults through Safer Transitions), a national QI initiative to improve handoffs and transitions.
Before Matthew Schreiber, MD, became chief medical officer of Piedmont Hospital in Atlanta, he was director of hospitalist services for the four-hospital Piedmont health system, and before that, a hospitalist for the system’s smallest hospital, 35-bed Piedmont Mountainside in Jasper, Ga., population 2,000, so he knows just how different transitions of care are between hospitals large and small.
In many rural communities, the hospitalist concept has only recently been introduced, and patients are accustomed to PCPs being responsible for all of their medical care. But it can be easier to achieve high-quality handoffs in rural areas because the number of physicians involved is much smaller, Dr. Schreiber says.
“At Piedmont Mountainside, only eight physicians made most of our referrals. It was possible to memorize their office numbers and their call-coverage arrangements,” he explains. Some doctors are accessible 24 hours, seven days a week, while others take their patients’ charts home overnight in case they get called. This encourages an individualized approach to communicating with them. “It makes the care feel more personal, with a different level of accountability,” Dr. Schreiber says. “You feel a connection to the patient and the doctor—and that your job isn’t done when the patient goes home.”
Rural hospitals and doctors also tend to have closer relationships with community services like home health agencies. “We can give the medication list to the home health nurse and say, ‘This is what we think the patient is taking. We want you to go in and find out what they’re actually taking and reconcile the two,’ ” Dr. Schreiber says.
However, small and rural hospitals—particularly stand-alone and critical access facilities—are less likely to have computerized tools for automating and facilitating care transitions, Dr. Schreiber says. In some cases, the rural hospitalist carries a pager and takes calls 24/7.
Dr. Schreiber says it’s important to hand patients a piece of paper that summarizes their condition, key events in the hospitalization, and new medications, all in patient-friendly language, to take home and post on the refrigerator. “In our experience, patients hold onto this document and bring it to the doctor’s office or even to the emergency room,” he says, adding that if the formal discharge summary doesn’t reach the PCP in time, this summary could be a godsend.
Visit our website for more information about local and national efforts to improve care transitions.
Check out the SHM website for information on Project BOOST (Better Outcomes for Older Adults through Safer Transitions), a national QI initiative to improve handoffs and transitions.
Before Matthew Schreiber, MD, became chief medical officer of Piedmont Hospital in Atlanta, he was director of hospitalist services for the four-hospital Piedmont health system, and before that, a hospitalist for the system’s smallest hospital, 35-bed Piedmont Mountainside in Jasper, Ga., population 2,000, so he knows just how different transitions of care are between hospitals large and small.
In many rural communities, the hospitalist concept has only recently been introduced, and patients are accustomed to PCPs being responsible for all of their medical care. But it can be easier to achieve high-quality handoffs in rural areas because the number of physicians involved is much smaller, Dr. Schreiber says.
“At Piedmont Mountainside, only eight physicians made most of our referrals. It was possible to memorize their office numbers and their call-coverage arrangements,” he explains. Some doctors are accessible 24 hours, seven days a week, while others take their patients’ charts home overnight in case they get called. This encourages an individualized approach to communicating with them. “It makes the care feel more personal, with a different level of accountability,” Dr. Schreiber says. “You feel a connection to the patient and the doctor—and that your job isn’t done when the patient goes home.”
Rural hospitals and doctors also tend to have closer relationships with community services like home health agencies. “We can give the medication list to the home health nurse and say, ‘This is what we think the patient is taking. We want you to go in and find out what they’re actually taking and reconcile the two,’ ” Dr. Schreiber says.
However, small and rural hospitals—particularly stand-alone and critical access facilities—are less likely to have computerized tools for automating and facilitating care transitions, Dr. Schreiber says. In some cases, the rural hospitalist carries a pager and takes calls 24/7.
Dr. Schreiber says it’s important to hand patients a piece of paper that summarizes their condition, key events in the hospitalization, and new medications, all in patient-friendly language, to take home and post on the refrigerator. “In our experience, patients hold onto this document and bring it to the doctor’s office or even to the emergency room,” he says, adding that if the formal discharge summary doesn’t reach the PCP in time, this summary could be a godsend.
Visit our website for more information about local and national efforts to improve care transitions.
Check out the SHM website for information on Project BOOST (Better Outcomes for Older Adults through Safer Transitions), a national QI initiative to improve handoffs and transitions.
Two-Way Street
Brad Schmidt, MD, can remember recruiting hospitalists to the HM program at Dean Clinic at St. Mary’s Hospital in Madison, Wis., seven years ago. He was a young doctor, just a couple of years removed from residency.
Back then, having Dr. Schmidt recruit hospitalists was a matter of necessity. He was the only hospitalist practicing at St. Mary’s. Today, hospitalists continue to be in charge of recruiting at Dean’s 18-physician HM department, but now it’s by design.
“It’s critical for hospitalists to get involved, because doctors being recruited want to be part of a team. They want to know how they would be contributing,” says Dr. Schmidt, who is the medical director of eight departments, including the HM department. “I also think it’s important for people to know who they are going to be working with.”
For hospitalists looking to advance their careers, being recruited by a group that heavily involves its own hospitalists in the process can provide an opportunity to get an in-depth look at the prospective job and community, observes Kenneth G. Simone, DO, FHM, founder and president of Hospitalist and Practice Solutions, a practice-management consultancy based in Veazie, Maine. At the same time, hospitalists who are active in recruitment efforts are helping their own pursuits, says Dr. Simone, a member of Team Hospitalist and author of several HM-centered books, including “Hospitalist Recruit-ment and Retention.”
It gives new meaning to the saying recruiting is a two-way street. In this case, it’s a two-way street to success if hospitalists at both ends of the recruitment process use the situation to their advantage.
Candidate Advantage
If given the chance to interact with hospitalists at a potential job, a candidate should really pay attention to what the workday is like, Dr. Simone says. How is the workload? What kind of specialist support are the hospitalists getting? Are primary-care physicians (PCPs) referring patients to the group? Is there a good rapport with nursing staff?
“As a candidate, I should be asking why they are looking for a provider,” Dr. Simone says. “Is it growth? Is it turnover due to burnout?”
Having hospitalists engaged in the recruitment effort gives a candidate a great opportunity to ask questions he or she might not be comfortable asking of a director or hospital human resources personnel, Dr. Simone says. A candidate also gets a chance to observe the level of collegiality among prospective coworkers and gauge if the hospitalists are happy in the workplace and with the community.
—Kenneth G. Simone, DO, FHM, president, Hospitalist and Practice Solutions, Veazie, Maine, Team Hospitalist member
“They want to know that they are not just a cog in the wheel, not just a person filling a shift,” Dr. Schmidt explains. “By and large, they want to be part of a team.”
According to Drs. Simone and Schmidt, hospitalist job candidates should make an effort to:
- Ask potential colleagues to show them the local neighborhoods, services, and cultural and entertainment amenities;
- Get the e-mail addresses and phone numbers of the hospitalists to contact them with any follow-up questions after the interview and site visit; and
- Meet the group’s newest hospitalists, as they are the people who are in the best position to talk about the job transition.
A candidate’s goal is to gather enough information to determine if the job opportunity is the best fit for them and their family, Dr. Schmidt says. But candidates must remember that the time they spend and the conversations they share with the group’s hospitalists are still part of the interview process, Dr. Simone emphasizes. “If the person interviewing for a job has a lot of questions about vacation time and workload, that could send a signal that he or she doesn’t have a good work ethic,” he says.
Conversely, candidates should be wary of any program that doesn’t in some degree include their hospitalists in the recruitment process. It could mean that the group is trying to hide something, or that morale is so low that the hospitalists don’t want to promote the program. “I personally would be very uncomfortable not knowing who my partners would be,” Dr. Schmidt says.
Other red flags to look out for are constant references to the job’s competitive salary, which could indicate problems in other areas that the hospitalist practice is trying to mask, and no references to challenging issues the group is facing. If the group appears too good to be true, it probably is, Dr. Simone says.
Recruitment = Leadership
Hospitalists who get involved in their group’s recruitment efforts show their employer and supervisor that they are team players and care about the group and its future. It shows they are willing to help the program beyond providing patient care, and it demonstrates to both current and future employers that they have valuable professional characteristics and skills.
“Hospitalists who are good at recruiting show that they are a leader, a good communicator, and a positive person,” Dr. Simone says. “They can put this on a resume and give examples of what they did to help bring a quality provider to the team.”
When recruiting, be honest about the program’s strengths and weaknesses. “You want to avoid telling a candidate something a program is not,” Dr. Schmidt says. “You should be open about the program’s goals, workload, and expectations.”
Hospitalists who help in recruiting can frame the challenges a program is facing in a positive light. If an HM program is having trouble with, for example, a pulmonology group that is understaffed, the hospitalist recruiting candidates could explain the program is temporarily cross-covering patients at night until a new specialist can be found, Dr. Simone explains. He also notes it’s always best to place negatives into a context that shows the hospitalist group is working on a solution.
Getting engaged in recruiting also helps a hospitalist improve their current job by strengthening their team with good doctors who care about doing quality work, Drs. Schmidt and Simone say.
And that is more important than building a resume. TH
Lisa Ryan is a freelance writer based in New Jersey.
Brad Schmidt, MD, can remember recruiting hospitalists to the HM program at Dean Clinic at St. Mary’s Hospital in Madison, Wis., seven years ago. He was a young doctor, just a couple of years removed from residency.
Back then, having Dr. Schmidt recruit hospitalists was a matter of necessity. He was the only hospitalist practicing at St. Mary’s. Today, hospitalists continue to be in charge of recruiting at Dean’s 18-physician HM department, but now it’s by design.
“It’s critical for hospitalists to get involved, because doctors being recruited want to be part of a team. They want to know how they would be contributing,” says Dr. Schmidt, who is the medical director of eight departments, including the HM department. “I also think it’s important for people to know who they are going to be working with.”
For hospitalists looking to advance their careers, being recruited by a group that heavily involves its own hospitalists in the process can provide an opportunity to get an in-depth look at the prospective job and community, observes Kenneth G. Simone, DO, FHM, founder and president of Hospitalist and Practice Solutions, a practice-management consultancy based in Veazie, Maine. At the same time, hospitalists who are active in recruitment efforts are helping their own pursuits, says Dr. Simone, a member of Team Hospitalist and author of several HM-centered books, including “Hospitalist Recruit-ment and Retention.”
It gives new meaning to the saying recruiting is a two-way street. In this case, it’s a two-way street to success if hospitalists at both ends of the recruitment process use the situation to their advantage.
Candidate Advantage
If given the chance to interact with hospitalists at a potential job, a candidate should really pay attention to what the workday is like, Dr. Simone says. How is the workload? What kind of specialist support are the hospitalists getting? Are primary-care physicians (PCPs) referring patients to the group? Is there a good rapport with nursing staff?
“As a candidate, I should be asking why they are looking for a provider,” Dr. Simone says. “Is it growth? Is it turnover due to burnout?”
Having hospitalists engaged in the recruitment effort gives a candidate a great opportunity to ask questions he or she might not be comfortable asking of a director or hospital human resources personnel, Dr. Simone says. A candidate also gets a chance to observe the level of collegiality among prospective coworkers and gauge if the hospitalists are happy in the workplace and with the community.
—Kenneth G. Simone, DO, FHM, president, Hospitalist and Practice Solutions, Veazie, Maine, Team Hospitalist member
“They want to know that they are not just a cog in the wheel, not just a person filling a shift,” Dr. Schmidt explains. “By and large, they want to be part of a team.”
According to Drs. Simone and Schmidt, hospitalist job candidates should make an effort to:
- Ask potential colleagues to show them the local neighborhoods, services, and cultural and entertainment amenities;
- Get the e-mail addresses and phone numbers of the hospitalists to contact them with any follow-up questions after the interview and site visit; and
- Meet the group’s newest hospitalists, as they are the people who are in the best position to talk about the job transition.
A candidate’s goal is to gather enough information to determine if the job opportunity is the best fit for them and their family, Dr. Schmidt says. But candidates must remember that the time they spend and the conversations they share with the group’s hospitalists are still part of the interview process, Dr. Simone emphasizes. “If the person interviewing for a job has a lot of questions about vacation time and workload, that could send a signal that he or she doesn’t have a good work ethic,” he says.
Conversely, candidates should be wary of any program that doesn’t in some degree include their hospitalists in the recruitment process. It could mean that the group is trying to hide something, or that morale is so low that the hospitalists don’t want to promote the program. “I personally would be very uncomfortable not knowing who my partners would be,” Dr. Schmidt says.
Other red flags to look out for are constant references to the job’s competitive salary, which could indicate problems in other areas that the hospitalist practice is trying to mask, and no references to challenging issues the group is facing. If the group appears too good to be true, it probably is, Dr. Simone says.
Recruitment = Leadership
Hospitalists who get involved in their group’s recruitment efforts show their employer and supervisor that they are team players and care about the group and its future. It shows they are willing to help the program beyond providing patient care, and it demonstrates to both current and future employers that they have valuable professional characteristics and skills.
“Hospitalists who are good at recruiting show that they are a leader, a good communicator, and a positive person,” Dr. Simone says. “They can put this on a resume and give examples of what they did to help bring a quality provider to the team.”
When recruiting, be honest about the program’s strengths and weaknesses. “You want to avoid telling a candidate something a program is not,” Dr. Schmidt says. “You should be open about the program’s goals, workload, and expectations.”
Hospitalists who help in recruiting can frame the challenges a program is facing in a positive light. If an HM program is having trouble with, for example, a pulmonology group that is understaffed, the hospitalist recruiting candidates could explain the program is temporarily cross-covering patients at night until a new specialist can be found, Dr. Simone explains. He also notes it’s always best to place negatives into a context that shows the hospitalist group is working on a solution.
Getting engaged in recruiting also helps a hospitalist improve their current job by strengthening their team with good doctors who care about doing quality work, Drs. Schmidt and Simone say.
And that is more important than building a resume. TH
Lisa Ryan is a freelance writer based in New Jersey.
Brad Schmidt, MD, can remember recruiting hospitalists to the HM program at Dean Clinic at St. Mary’s Hospital in Madison, Wis., seven years ago. He was a young doctor, just a couple of years removed from residency.
Back then, having Dr. Schmidt recruit hospitalists was a matter of necessity. He was the only hospitalist practicing at St. Mary’s. Today, hospitalists continue to be in charge of recruiting at Dean’s 18-physician HM department, but now it’s by design.
“It’s critical for hospitalists to get involved, because doctors being recruited want to be part of a team. They want to know how they would be contributing,” says Dr. Schmidt, who is the medical director of eight departments, including the HM department. “I also think it’s important for people to know who they are going to be working with.”
For hospitalists looking to advance their careers, being recruited by a group that heavily involves its own hospitalists in the process can provide an opportunity to get an in-depth look at the prospective job and community, observes Kenneth G. Simone, DO, FHM, founder and president of Hospitalist and Practice Solutions, a practice-management consultancy based in Veazie, Maine. At the same time, hospitalists who are active in recruitment efforts are helping their own pursuits, says Dr. Simone, a member of Team Hospitalist and author of several HM-centered books, including “Hospitalist Recruit-ment and Retention.”
It gives new meaning to the saying recruiting is a two-way street. In this case, it’s a two-way street to success if hospitalists at both ends of the recruitment process use the situation to their advantage.
Candidate Advantage
If given the chance to interact with hospitalists at a potential job, a candidate should really pay attention to what the workday is like, Dr. Simone says. How is the workload? What kind of specialist support are the hospitalists getting? Are primary-care physicians (PCPs) referring patients to the group? Is there a good rapport with nursing staff?
“As a candidate, I should be asking why they are looking for a provider,” Dr. Simone says. “Is it growth? Is it turnover due to burnout?”
Having hospitalists engaged in the recruitment effort gives a candidate a great opportunity to ask questions he or she might not be comfortable asking of a director or hospital human resources personnel, Dr. Simone says. A candidate also gets a chance to observe the level of collegiality among prospective coworkers and gauge if the hospitalists are happy in the workplace and with the community.
—Kenneth G. Simone, DO, FHM, president, Hospitalist and Practice Solutions, Veazie, Maine, Team Hospitalist member
“They want to know that they are not just a cog in the wheel, not just a person filling a shift,” Dr. Schmidt explains. “By and large, they want to be part of a team.”
According to Drs. Simone and Schmidt, hospitalist job candidates should make an effort to:
- Ask potential colleagues to show them the local neighborhoods, services, and cultural and entertainment amenities;
- Get the e-mail addresses and phone numbers of the hospitalists to contact them with any follow-up questions after the interview and site visit; and
- Meet the group’s newest hospitalists, as they are the people who are in the best position to talk about the job transition.
A candidate’s goal is to gather enough information to determine if the job opportunity is the best fit for them and their family, Dr. Schmidt says. But candidates must remember that the time they spend and the conversations they share with the group’s hospitalists are still part of the interview process, Dr. Simone emphasizes. “If the person interviewing for a job has a lot of questions about vacation time and workload, that could send a signal that he or she doesn’t have a good work ethic,” he says.
Conversely, candidates should be wary of any program that doesn’t in some degree include their hospitalists in the recruitment process. It could mean that the group is trying to hide something, or that morale is so low that the hospitalists don’t want to promote the program. “I personally would be very uncomfortable not knowing who my partners would be,” Dr. Schmidt says.
Other red flags to look out for are constant references to the job’s competitive salary, which could indicate problems in other areas that the hospitalist practice is trying to mask, and no references to challenging issues the group is facing. If the group appears too good to be true, it probably is, Dr. Simone says.
Recruitment = Leadership
Hospitalists who get involved in their group’s recruitment efforts show their employer and supervisor that they are team players and care about the group and its future. It shows they are willing to help the program beyond providing patient care, and it demonstrates to both current and future employers that they have valuable professional characteristics and skills.
“Hospitalists who are good at recruiting show that they are a leader, a good communicator, and a positive person,” Dr. Simone says. “They can put this on a resume and give examples of what they did to help bring a quality provider to the team.”
When recruiting, be honest about the program’s strengths and weaknesses. “You want to avoid telling a candidate something a program is not,” Dr. Schmidt says. “You should be open about the program’s goals, workload, and expectations.”
Hospitalists who help in recruiting can frame the challenges a program is facing in a positive light. If an HM program is having trouble with, for example, a pulmonology group that is understaffed, the hospitalist recruiting candidates could explain the program is temporarily cross-covering patients at night until a new specialist can be found, Dr. Simone explains. He also notes it’s always best to place negatives into a context that shows the hospitalist group is working on a solution.
Getting engaged in recruiting also helps a hospitalist improve their current job by strengthening their team with good doctors who care about doing quality work, Drs. Schmidt and Simone say.
And that is more important than building a resume. TH
Lisa Ryan is a freelance writer based in New Jersey.
Change You Should Believe In
Christina Payne, MD, is a third-year resident at Emory University Hospital in Atlanta who will begin her first hospitalist job, with Emory in September. In spite of her dearth of practical experience, she already has experience researching one of the most vexing problems confronting HM: how to improve transitions of care.
Dr. Payne has been studying the benefits of a structured electronic tool that generates a standardized sign-out list of a hospital team’s full census at the time of shift change, compared with the usual, highly variable sign-out practices of medical residents. At a poster presentation at Internal Medicine 2010 in April in Toronto, Dr. Payne and colleagues reported that residents using the tool were twice as confident at performing handoffs, had lower rates of perceived near-miss events, and were happier.1
“Hospitalists everywhere are starting to realize the importance of trying to reduce opportunities for human error that occur during care transitions,” Dr. Payne says. “The biggest thing I learned from this research is the importance of standardizing the handoff process [with information communicated consistently].
“It is essential to keep communication lines open,” Dr. Payne adds. “No tool can replace the importance of communication between doctors and the need to sit down and talk. The ideal signout happens in a quiet room where the two of you can talk about active patients and achieve rapport. But, realistically, how often does that happen?”
Standardization is one of a handful of strategies hospitalists, researchers, and policymakers are using to tackle transitions—both in-hospital handoffs and post-discharge transitions—with outpatient care. Some hospitalists are using practice simulations and training strategies; others have implemented medication reconciliation checks at every discharge, checklists and other communication strategies, team-based quality-improvement (QI) initiatives, and new technologies to enhance and streamline communication. Some interventions follow the patient from the hospital to the community physician with a phone call, follow-up clinic, or other contact; others aim to empower the patient to be a better self-advocate. But for hospitalists, the challenge is to communicate the right amount of transfer information to the right receiver at the right time.
No matter the technique, the goal is the same: Improve the handoff and discharge process in a way that promotes efficiency and patient safety. And hospitalists are at the forefront of the changing landscape of care transitions.
Under the Microscope
Care transitions of all kinds are under the magnifying glass of national healthcare reform, with growing recognition of the need to make care safer and reduce the preventable, costly hospital readmissions caused by incomplete handoffs. Care transitions for hospitalists include internal handoffs, both at daily shift changes and at service changes when an outgoing provider is leaving after a period of consecutive daily shifts. These typically involve a sign-out process and face-to-face encounter, with some kind of written backup. One teaching institution reported that such handoffs take place 4,000 times per day in the hospital, or 1.6 million times per year.2
—Arpana Vidyarthi, MD, University of California at San Francisco
Geographical transitions can be from one floor or department to another, or out the hospital door to another facility or home. Transitions typically involve a discharge process and a written discharge summary. Care transitions also include hospital admissions, which put the hospitalist in the role of handoff receiver rather than initiator, plus a variety of other transitions involving nurses, physician extenders, and other practitioners.
Each transition is a major decision point in the course of a patient’s hospitalization; each transition also presents a time of heightened vulnerability (e.g., potential communication breakdowns, medication errors, patient anxiety or confusion, etc.). In fact, according to a Transitions of Care Consensus Policy Statement published in 2009 by SHM and five other medical societies, handoffs are ubiquitous in HM, with significant patient safety and quality deficiencies in handoffs existing in the current system.3
Poor communication at the time of handoff has been implicated in near-misses and adverse events in a variety of healthcare contexts, including 70% of hospital sentinel events studied by The Joint Commission, which named standardized handoffs (with an opportunity for interactive communication) as a National Patient Safety Goal in 2006.4 The federal government is studying care transitions, supporting demonstration projects for Medicare enrollees, and including readmission rates in national hospital report card data.
“Transitions of care and handoffs are a huge focus right now because of the increased fragmentation of care in the United States. Hospitalists are in charge of a greater percentage of hospitalized patients, which means more coordination of care is needed,” says Vineet Arora, MD, MA, FHM, assistant professor of medicine and associate director of the internal-medicine residency at the University of Chicago, and chair of the SHM task force on handoffs.
Inadequate communication and poor care transitions can undermine hospitalists’ best care-planning efforts, erode patients’ and families’ confidence and satisfaction with hospital care, and leave primary-care physicians (PCPs) feeling unsatisfied with the relationship. As many as 1 in 5 Medicare beneficiary hospitalizations result in a readmission within 30 days, and while not all of these are preventable, far too many are.5 Another prospective cohort study found that 1 in 5 patients discharged from the hospital to the home experienced an adverse event within three weeks of discharge.6 Complex comorbidities, advanced age, unknown PCP, and limited healthcare literacy present hospitalists with extremely difficult transitions.
Patient safety and cost control are the linchpins to national efforts to improve transitions of care. Dr. Arora recently coauthored an original research paper, which will be published in the Journal of Hospital Medicine in September, showing older hospitalized patients are twice as likely to report problems after discharge if their PCPs were not aware they were hospitalized.
“With escalating healthcare costs, people are looking at ways to save money and reduce redundant care,” Dr. Arora explains, pointing out, as an example, repeated tests resulting from inadequate communication between healthcare providers.
The System Must Change
“All of the effort we put into saving someone’s life—the years of experience, training, medical school, and residency—all of it comes to bear on that hospitalized patient. And it can all be unraveled at the time of discharge if it’s not handled properly,” says Arpana Vidyarthi, MD, a hospitalist and director of quality at the University of California at San Francisco.
Dr. Vidyarthi views in-hospital and discharge transitions as integrally related. “The analysis is similar, even if different techniques may be needed,” she says, adding that, fundamentally, it involves having a system that allows people—or forces them—to do the “right thing.”
That’s why achieving effective care transitions will require more than just a standardized tool or process, Dr. Vidyarthi says. “This is about understanding the ways people communicate and finding ways to train them to communicate better,” she says. “The problem we have is not a lack of information, but how to communicate what, to whom, and when.”
What’s really needed, Dr. Vidyarthi says, is a hospital’s commitment to more effective transitions and its hospitalists’ leadership in driving a comprehensive, multidisciplinary, team- and evidence-based QI process. The new process should be a QI-based solution to a hospital’s care-transitions issues. “Before you can standardize your process, you need to understand it,” she says. “This is a complex problem, and it needs a multifaceted solution. But this lies squarely within the hospitalist arena. We’re part of everything that happens in the hospital.
—Anuj Dalal, MD, Brigham and Women’s Hospital, Boston
Hospital administrators are looking to HM to solve transition and readmission problems now, says Tina Budnitz, MPH, BOOST Project Director (Better Outcomes for Older Adults through Safe Transitions). She expects the scrutiny from the C-suite, legislators, and watchdog groups to increase as the spotlight continues to shine on the healthcare system.
“Any hospitalist can act as a leader in their institution,” Budnitz says. “Be a change agent, pull a group together, and start asking questions: Do we have safe care-transitions practices and processes in place? Just by asking the right question, you can be a catalyst for the system.”
Budnitz also emphasizes the importance of teamwork in the hospital setting. “How can I help my teammates? What am I communicating to the nurses on rounds?” she says. “Can you initiate dialogue with your outpatient medical groups: ‘These faxes we’re sending you—is that information getting to you in ways and times that are helpful? And, by the way, when your patient is admitted, this information would really help me.’ ”
Innovative Strategies
One of the most important initiatives responding to concerns about care transitions is Project BOOST (www.hos pitalmedicine.org/BOOST), a comprehensive toolkit for improving a hospital’s transitions of care. The project aims to build a national consensus for best practices in transitions; collaborate with representatives from the Agency for Healthcare Research and Quality (AHRQ), the Centers for Medicare and Medicaid Services (CMS), and the Joint Commission; and develop a national resource library, Budnitz says.
“Project BOOST not only puts forth best practices for admitting patients, planning for discharge, and then doing the discharge, it also helps show facilities how to change their systems, with resources and tools for analyzing and re-engineering the system,” she says. “Sites get one-to-one assistance from a mentor.”
Six hospitals signed on to the pilot program in 2008; 24 more joined last year. In January, SHM announced a collaborative with the University of Michigan and Blue Cross Blue Shield of Michigan for 15 Michigan hospitals to receive training and mentorship starting in May. And last month, SHM and the California HealthCare Foundation announced a Project BOOST initiative for 20 of the health system’s hospitals (see “California Dreamin’”, p. 6). Other free resources offered on the BOOST Web portal include clinical, data collection, and project management tools. SHM also has a DVD that explains how to use the “teachback” method to improve communication with patients.
Jennifer Myers, MD, FHM, assistant professor of clinical medicine and patient-safety officer at the Hospital of the University of Pennsylvania in Philadelphia, is a Project BOOST participant who spearheaded a process change to improve the quality of her facility’s discharge summary, along with accompanying resident education.7 The discharge summary recently was integrated with the hospital’s electronic health record (EHR) system.
“We’ve gone from dictating the discharge summary to an electronic version completed by the hospitalist, with prompts for key components of the summary, which allows us to create summaries more efficiently—ideally on the day of discharge, but usually within 48 hours,” Dr. Myers says. “We previously researched whether teaching made a difference in the quality of discharges; we found that it did. So we look forward to standardizing our teaching approach around this important topic for all residents.”
Another care-transitions innovation receiving a lot of attention from the government and the private sector is Project RED (Re-Engineered Discharge), led by Brian Jack, MD, vice chair of the department of family medicine at Boston Medical Center. The Project RED research group develops and tests strategies to improve the hospital discharge process to promote patient safety and reduce rehospitalization rates.
“We used re-engineering tools borrowed from other fields, brought together experts from all over the hospital, divided up the whole discharge process, and identified key principles,” Dr. Jack explains. The resulting discharge strategy is reflected in an 11-item checklist of discrete, mutually reinforcing components, which have been shown to reduce rehospitalization rates by 32% while raising patient satisfaction.8 It includes comprehensive discharge and after-hospital plans, a nurse discharge advocate, and a medication reconciliation phone call to the patient. A virtual “patient advocate,” a computerized avatar named Louise, is now being tested. If successful, it will allow patients to interact with a touch-screen teacher of the after-care plan who has time to work at the patient’s pace.
Technology and Transitions
Informatics can be a key player in facilitating care transitions, says Anuj Dalal, MD, a hospitalist and instructor in medicine at Brigham and Women’s Hospital in Boston. He is using one of his hospital’s technological strengths—a well-established, firewall-protected e-mail system—to help improve the discharge process.
“We decided to try to improve awareness of test results pending at the time of discharge,” Dr. Dalal explains. “We created an intervention that automatically triggers an e-mail with the finalized test results to the responsible providers. The intervention creates a loop of communication between the inpatient attending and the PCP. What we hope to show in our research over the next year or two is whether the intervention actually increases awareness of test results by providers.”
One thing to remember is that “all kinds of things can go wrong with care transitions,” no matter the size of the institution, the experience of the staff, or technological limitations, says Vineet Chopra, MD, FACP, a hospitalist at the University of Michigan Health System in Ann Arbor. “The problems of transitions vary from place to place, day to day, time of day, shift changes; and let’s not forget physician extenders and the other members of the healthcare team,” he says. “The more complicated the team, the more complicated the information needing to be handed off becomes.”
Before he joined the group at the university, Dr. Chopra worked at a community hospital, St. Joseph’s Mercy Hospital in Hot Springs, Ark. “It’s hard to come up with a one-size-fits-all solution when there are so many variables,” he says. At the community hospital, “we mandated that the hospitalist call the PCP at the time of discharge. At the academic medical center, we share an EHR with the PCPs and can reach them electronically. We are required to have the discharge summary in the computer before the patient leaves the hospital, and we mandate that hospitalists are reachable by e-mail or phone when they are off.
“I’m not a believer in throwing more technology at problems and just adding more layers of information tools,” Dr. Chopra adds. “Hospitalists who used to carry stethoscopes now also have a clipboard, phone, pager, PDA, and nine different signouts in their pockets. What we want to do is make their life easier. Here, we are looking at technology as a means to do that.”
Dr. Chopra and hospitalist colleague Prasanth Gosineni, MD, have been working with an Ann Arbor tech company called Synaptin to develop a lightweight, mobile client application designed to work on smartphones. Still in pilot testing, it would allow for task-oriented and priority-based messaging in real time and the systematic transfer of important information for the next hospitalist shift.
“You need to be able to share information in a systematic way, but that’s only half of the answer. The other half is the ability to ask specific questions,” Dr. Chopra says. “Technology doesn’t take away from the face-to-face encounter that needs to happen. Nothing will replace face time, but part of the solution is to provide data efficiently and in a way that is easily accessible.”
Dr. Chopra admits that EHR presents both positives and negatives to improved transitions and patient care, “depending on how well it works and what smart features it offers,” he says, “but also recognizing that EHR and other technologies have also taken us farther away from face-to-face exchanges. Some would say that’s part of the problem.”
Handoffs, discharges, and other transitions are ubiquitous in HM—and fraught with the potential for costly and harmful errors. The ideal of an interactive, face-to-face handoff simply is not available for many care transitions. However, hospitalists are challenged to find solutions that will work in their hospitals, with their teams, and their types of patients. Patients and policymakers expect nothing less. TH
Larry Beresford is a freelance writer based in Oakland, Calif.
References
- Payne C, Stein J, Dressler D. Implementation of a structured electronic tool to improve patient handoffs and resident satisfaction. Poster abstract: Internal Medicine 2010, April 21-24, 2010, Toronto.
- Vidyarthi AR. Triple Handoff. AHRQ WebM&M website. Available at: webmm.ahrq.gov/case.aspx? caseID=134. Published May 2006. Accessed May 29, 2010.
- Snow V, Beck D, Budnitz T, et al. Transitions of Care Consensus Policy Statement: American College of Physicians, Society of General Internal Medicine, Society of Hospital Medicine, American Geriatrics Society, American College of Emergency Physicians, and Society for Academic Emergency Medicine. J Hosp Med. 2009;4(6):364-370.
- 2006 National Patient Safety Goals. The Joint Commission website. Available at: www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/06_npsgs.htm. Accessed June 8, 2010.
- Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009; 2:360:1418-1428.
- Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med. 2003;138(3):161-167.
- Myers JS, Jaipaul CK, Kogan JR, Krekun S, Bellini LM, Shea JA. Are discharge summaries teachable? The effects of a discharge summary curriculum on the quality of discharge summaries in an internal medicine residency program. Acad Med. 2006; 81(10):S5-S8.
- Jack BW, Chetty VK, Anthony D, et al. A reengineered hospital discharge program to decrease rehospitalization: a randomized trial. Ann Intern Med. 2009;150(3):178-187.
- Arora VM, Manjarrez E, Dressler DD, Basaviah P, Halasyamani L, Kripalani S. Hospitalist handoffs: a systematic review and task force recommendations. J Hosp Med. 2009;4(7): 433-440.
- Halasyamani L, Kripalani S, Coleman E, et al. Transition of care for hospitalized elderly patients—development of a discharge checklist for hospitalists. J Hosp Med. 2006;1(6):354-360.
- Schnipper JL, Kirwin JL, Cotugno MC, et al. Role of pharmacist counseling in preventing adverse drug events after hospitalization. Arch Int Med. 2006;166(5):565-571.
- Dudas V, Bookwalter T, Kerr KM, Pantilat SZ. The impact of follow-up telephone calls to patients after hospitalization. Am J Med. 2001;111(9B): 26S-30S.
Christina Payne, MD, is a third-year resident at Emory University Hospital in Atlanta who will begin her first hospitalist job, with Emory in September. In spite of her dearth of practical experience, she already has experience researching one of the most vexing problems confronting HM: how to improve transitions of care.
Dr. Payne has been studying the benefits of a structured electronic tool that generates a standardized sign-out list of a hospital team’s full census at the time of shift change, compared with the usual, highly variable sign-out practices of medical residents. At a poster presentation at Internal Medicine 2010 in April in Toronto, Dr. Payne and colleagues reported that residents using the tool were twice as confident at performing handoffs, had lower rates of perceived near-miss events, and were happier.1
“Hospitalists everywhere are starting to realize the importance of trying to reduce opportunities for human error that occur during care transitions,” Dr. Payne says. “The biggest thing I learned from this research is the importance of standardizing the handoff process [with information communicated consistently].
“It is essential to keep communication lines open,” Dr. Payne adds. “No tool can replace the importance of communication between doctors and the need to sit down and talk. The ideal signout happens in a quiet room where the two of you can talk about active patients and achieve rapport. But, realistically, how often does that happen?”
Standardization is one of a handful of strategies hospitalists, researchers, and policymakers are using to tackle transitions—both in-hospital handoffs and post-discharge transitions—with outpatient care. Some hospitalists are using practice simulations and training strategies; others have implemented medication reconciliation checks at every discharge, checklists and other communication strategies, team-based quality-improvement (QI) initiatives, and new technologies to enhance and streamline communication. Some interventions follow the patient from the hospital to the community physician with a phone call, follow-up clinic, or other contact; others aim to empower the patient to be a better self-advocate. But for hospitalists, the challenge is to communicate the right amount of transfer information to the right receiver at the right time.
No matter the technique, the goal is the same: Improve the handoff and discharge process in a way that promotes efficiency and patient safety. And hospitalists are at the forefront of the changing landscape of care transitions.
Under the Microscope
Care transitions of all kinds are under the magnifying glass of national healthcare reform, with growing recognition of the need to make care safer and reduce the preventable, costly hospital readmissions caused by incomplete handoffs. Care transitions for hospitalists include internal handoffs, both at daily shift changes and at service changes when an outgoing provider is leaving after a period of consecutive daily shifts. These typically involve a sign-out process and face-to-face encounter, with some kind of written backup. One teaching institution reported that such handoffs take place 4,000 times per day in the hospital, or 1.6 million times per year.2
—Arpana Vidyarthi, MD, University of California at San Francisco
Geographical transitions can be from one floor or department to another, or out the hospital door to another facility or home. Transitions typically involve a discharge process and a written discharge summary. Care transitions also include hospital admissions, which put the hospitalist in the role of handoff receiver rather than initiator, plus a variety of other transitions involving nurses, physician extenders, and other practitioners.
Each transition is a major decision point in the course of a patient’s hospitalization; each transition also presents a time of heightened vulnerability (e.g., potential communication breakdowns, medication errors, patient anxiety or confusion, etc.). In fact, according to a Transitions of Care Consensus Policy Statement published in 2009 by SHM and five other medical societies, handoffs are ubiquitous in HM, with significant patient safety and quality deficiencies in handoffs existing in the current system.3
Poor communication at the time of handoff has been implicated in near-misses and adverse events in a variety of healthcare contexts, including 70% of hospital sentinel events studied by The Joint Commission, which named standardized handoffs (with an opportunity for interactive communication) as a National Patient Safety Goal in 2006.4 The federal government is studying care transitions, supporting demonstration projects for Medicare enrollees, and including readmission rates in national hospital report card data.
“Transitions of care and handoffs are a huge focus right now because of the increased fragmentation of care in the United States. Hospitalists are in charge of a greater percentage of hospitalized patients, which means more coordination of care is needed,” says Vineet Arora, MD, MA, FHM, assistant professor of medicine and associate director of the internal-medicine residency at the University of Chicago, and chair of the SHM task force on handoffs.
Inadequate communication and poor care transitions can undermine hospitalists’ best care-planning efforts, erode patients’ and families’ confidence and satisfaction with hospital care, and leave primary-care physicians (PCPs) feeling unsatisfied with the relationship. As many as 1 in 5 Medicare beneficiary hospitalizations result in a readmission within 30 days, and while not all of these are preventable, far too many are.5 Another prospective cohort study found that 1 in 5 patients discharged from the hospital to the home experienced an adverse event within three weeks of discharge.6 Complex comorbidities, advanced age, unknown PCP, and limited healthcare literacy present hospitalists with extremely difficult transitions.
Patient safety and cost control are the linchpins to national efforts to improve transitions of care. Dr. Arora recently coauthored an original research paper, which will be published in the Journal of Hospital Medicine in September, showing older hospitalized patients are twice as likely to report problems after discharge if their PCPs were not aware they were hospitalized.
“With escalating healthcare costs, people are looking at ways to save money and reduce redundant care,” Dr. Arora explains, pointing out, as an example, repeated tests resulting from inadequate communication between healthcare providers.
The System Must Change
“All of the effort we put into saving someone’s life—the years of experience, training, medical school, and residency—all of it comes to bear on that hospitalized patient. And it can all be unraveled at the time of discharge if it’s not handled properly,” says Arpana Vidyarthi, MD, a hospitalist and director of quality at the University of California at San Francisco.
Dr. Vidyarthi views in-hospital and discharge transitions as integrally related. “The analysis is similar, even if different techniques may be needed,” she says, adding that, fundamentally, it involves having a system that allows people—or forces them—to do the “right thing.”
That’s why achieving effective care transitions will require more than just a standardized tool or process, Dr. Vidyarthi says. “This is about understanding the ways people communicate and finding ways to train them to communicate better,” she says. “The problem we have is not a lack of information, but how to communicate what, to whom, and when.”
What’s really needed, Dr. Vidyarthi says, is a hospital’s commitment to more effective transitions and its hospitalists’ leadership in driving a comprehensive, multidisciplinary, team- and evidence-based QI process. The new process should be a QI-based solution to a hospital’s care-transitions issues. “Before you can standardize your process, you need to understand it,” she says. “This is a complex problem, and it needs a multifaceted solution. But this lies squarely within the hospitalist arena. We’re part of everything that happens in the hospital.
—Anuj Dalal, MD, Brigham and Women’s Hospital, Boston
Hospital administrators are looking to HM to solve transition and readmission problems now, says Tina Budnitz, MPH, BOOST Project Director (Better Outcomes for Older Adults through Safe Transitions). She expects the scrutiny from the C-suite, legislators, and watchdog groups to increase as the spotlight continues to shine on the healthcare system.
“Any hospitalist can act as a leader in their institution,” Budnitz says. “Be a change agent, pull a group together, and start asking questions: Do we have safe care-transitions practices and processes in place? Just by asking the right question, you can be a catalyst for the system.”
Budnitz also emphasizes the importance of teamwork in the hospital setting. “How can I help my teammates? What am I communicating to the nurses on rounds?” she says. “Can you initiate dialogue with your outpatient medical groups: ‘These faxes we’re sending you—is that information getting to you in ways and times that are helpful? And, by the way, when your patient is admitted, this information would really help me.’ ”
Innovative Strategies
One of the most important initiatives responding to concerns about care transitions is Project BOOST (www.hos pitalmedicine.org/BOOST), a comprehensive toolkit for improving a hospital’s transitions of care. The project aims to build a national consensus for best practices in transitions; collaborate with representatives from the Agency for Healthcare Research and Quality (AHRQ), the Centers for Medicare and Medicaid Services (CMS), and the Joint Commission; and develop a national resource library, Budnitz says.
“Project BOOST not only puts forth best practices for admitting patients, planning for discharge, and then doing the discharge, it also helps show facilities how to change their systems, with resources and tools for analyzing and re-engineering the system,” she says. “Sites get one-to-one assistance from a mentor.”
Six hospitals signed on to the pilot program in 2008; 24 more joined last year. In January, SHM announced a collaborative with the University of Michigan and Blue Cross Blue Shield of Michigan for 15 Michigan hospitals to receive training and mentorship starting in May. And last month, SHM and the California HealthCare Foundation announced a Project BOOST initiative for 20 of the health system’s hospitals (see “California Dreamin’”, p. 6). Other free resources offered on the BOOST Web portal include clinical, data collection, and project management tools. SHM also has a DVD that explains how to use the “teachback” method to improve communication with patients.
Jennifer Myers, MD, FHM, assistant professor of clinical medicine and patient-safety officer at the Hospital of the University of Pennsylvania in Philadelphia, is a Project BOOST participant who spearheaded a process change to improve the quality of her facility’s discharge summary, along with accompanying resident education.7 The discharge summary recently was integrated with the hospital’s electronic health record (EHR) system.
“We’ve gone from dictating the discharge summary to an electronic version completed by the hospitalist, with prompts for key components of the summary, which allows us to create summaries more efficiently—ideally on the day of discharge, but usually within 48 hours,” Dr. Myers says. “We previously researched whether teaching made a difference in the quality of discharges; we found that it did. So we look forward to standardizing our teaching approach around this important topic for all residents.”
Another care-transitions innovation receiving a lot of attention from the government and the private sector is Project RED (Re-Engineered Discharge), led by Brian Jack, MD, vice chair of the department of family medicine at Boston Medical Center. The Project RED research group develops and tests strategies to improve the hospital discharge process to promote patient safety and reduce rehospitalization rates.
“We used re-engineering tools borrowed from other fields, brought together experts from all over the hospital, divided up the whole discharge process, and identified key principles,” Dr. Jack explains. The resulting discharge strategy is reflected in an 11-item checklist of discrete, mutually reinforcing components, which have been shown to reduce rehospitalization rates by 32% while raising patient satisfaction.8 It includes comprehensive discharge and after-hospital plans, a nurse discharge advocate, and a medication reconciliation phone call to the patient. A virtual “patient advocate,” a computerized avatar named Louise, is now being tested. If successful, it will allow patients to interact with a touch-screen teacher of the after-care plan who has time to work at the patient’s pace.
Technology and Transitions
Informatics can be a key player in facilitating care transitions, says Anuj Dalal, MD, a hospitalist and instructor in medicine at Brigham and Women’s Hospital in Boston. He is using one of his hospital’s technological strengths—a well-established, firewall-protected e-mail system—to help improve the discharge process.
“We decided to try to improve awareness of test results pending at the time of discharge,” Dr. Dalal explains. “We created an intervention that automatically triggers an e-mail with the finalized test results to the responsible providers. The intervention creates a loop of communication between the inpatient attending and the PCP. What we hope to show in our research over the next year or two is whether the intervention actually increases awareness of test results by providers.”
One thing to remember is that “all kinds of things can go wrong with care transitions,” no matter the size of the institution, the experience of the staff, or technological limitations, says Vineet Chopra, MD, FACP, a hospitalist at the University of Michigan Health System in Ann Arbor. “The problems of transitions vary from place to place, day to day, time of day, shift changes; and let’s not forget physician extenders and the other members of the healthcare team,” he says. “The more complicated the team, the more complicated the information needing to be handed off becomes.”
Before he joined the group at the university, Dr. Chopra worked at a community hospital, St. Joseph’s Mercy Hospital in Hot Springs, Ark. “It’s hard to come up with a one-size-fits-all solution when there are so many variables,” he says. At the community hospital, “we mandated that the hospitalist call the PCP at the time of discharge. At the academic medical center, we share an EHR with the PCPs and can reach them electronically. We are required to have the discharge summary in the computer before the patient leaves the hospital, and we mandate that hospitalists are reachable by e-mail or phone when they are off.
“I’m not a believer in throwing more technology at problems and just adding more layers of information tools,” Dr. Chopra adds. “Hospitalists who used to carry stethoscopes now also have a clipboard, phone, pager, PDA, and nine different signouts in their pockets. What we want to do is make their life easier. Here, we are looking at technology as a means to do that.”
Dr. Chopra and hospitalist colleague Prasanth Gosineni, MD, have been working with an Ann Arbor tech company called Synaptin to develop a lightweight, mobile client application designed to work on smartphones. Still in pilot testing, it would allow for task-oriented and priority-based messaging in real time and the systematic transfer of important information for the next hospitalist shift.
“You need to be able to share information in a systematic way, but that’s only half of the answer. The other half is the ability to ask specific questions,” Dr. Chopra says. “Technology doesn’t take away from the face-to-face encounter that needs to happen. Nothing will replace face time, but part of the solution is to provide data efficiently and in a way that is easily accessible.”
Dr. Chopra admits that EHR presents both positives and negatives to improved transitions and patient care, “depending on how well it works and what smart features it offers,” he says, “but also recognizing that EHR and other technologies have also taken us farther away from face-to-face exchanges. Some would say that’s part of the problem.”
Handoffs, discharges, and other transitions are ubiquitous in HM—and fraught with the potential for costly and harmful errors. The ideal of an interactive, face-to-face handoff simply is not available for many care transitions. However, hospitalists are challenged to find solutions that will work in their hospitals, with their teams, and their types of patients. Patients and policymakers expect nothing less. TH
Larry Beresford is a freelance writer based in Oakland, Calif.
References
- Payne C, Stein J, Dressler D. Implementation of a structured electronic tool to improve patient handoffs and resident satisfaction. Poster abstract: Internal Medicine 2010, April 21-24, 2010, Toronto.
- Vidyarthi AR. Triple Handoff. AHRQ WebM&M website. Available at: webmm.ahrq.gov/case.aspx? caseID=134. Published May 2006. Accessed May 29, 2010.
- Snow V, Beck D, Budnitz T, et al. Transitions of Care Consensus Policy Statement: American College of Physicians, Society of General Internal Medicine, Society of Hospital Medicine, American Geriatrics Society, American College of Emergency Physicians, and Society for Academic Emergency Medicine. J Hosp Med. 2009;4(6):364-370.
- 2006 National Patient Safety Goals. The Joint Commission website. Available at: www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/06_npsgs.htm. Accessed June 8, 2010.
- Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009; 2:360:1418-1428.
- Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med. 2003;138(3):161-167.
- Myers JS, Jaipaul CK, Kogan JR, Krekun S, Bellini LM, Shea JA. Are discharge summaries teachable? The effects of a discharge summary curriculum on the quality of discharge summaries in an internal medicine residency program. Acad Med. 2006; 81(10):S5-S8.
- Jack BW, Chetty VK, Anthony D, et al. A reengineered hospital discharge program to decrease rehospitalization: a randomized trial. Ann Intern Med. 2009;150(3):178-187.
- Arora VM, Manjarrez E, Dressler DD, Basaviah P, Halasyamani L, Kripalani S. Hospitalist handoffs: a systematic review and task force recommendations. J Hosp Med. 2009;4(7): 433-440.
- Halasyamani L, Kripalani S, Coleman E, et al. Transition of care for hospitalized elderly patients—development of a discharge checklist for hospitalists. J Hosp Med. 2006;1(6):354-360.
- Schnipper JL, Kirwin JL, Cotugno MC, et al. Role of pharmacist counseling in preventing adverse drug events after hospitalization. Arch Int Med. 2006;166(5):565-571.
- Dudas V, Bookwalter T, Kerr KM, Pantilat SZ. The impact of follow-up telephone calls to patients after hospitalization. Am J Med. 2001;111(9B): 26S-30S.
Christina Payne, MD, is a third-year resident at Emory University Hospital in Atlanta who will begin her first hospitalist job, with Emory in September. In spite of her dearth of practical experience, she already has experience researching one of the most vexing problems confronting HM: how to improve transitions of care.
Dr. Payne has been studying the benefits of a structured electronic tool that generates a standardized sign-out list of a hospital team’s full census at the time of shift change, compared with the usual, highly variable sign-out practices of medical residents. At a poster presentation at Internal Medicine 2010 in April in Toronto, Dr. Payne and colleagues reported that residents using the tool were twice as confident at performing handoffs, had lower rates of perceived near-miss events, and were happier.1
“Hospitalists everywhere are starting to realize the importance of trying to reduce opportunities for human error that occur during care transitions,” Dr. Payne says. “The biggest thing I learned from this research is the importance of standardizing the handoff process [with information communicated consistently].
“It is essential to keep communication lines open,” Dr. Payne adds. “No tool can replace the importance of communication between doctors and the need to sit down and talk. The ideal signout happens in a quiet room where the two of you can talk about active patients and achieve rapport. But, realistically, how often does that happen?”
Standardization is one of a handful of strategies hospitalists, researchers, and policymakers are using to tackle transitions—both in-hospital handoffs and post-discharge transitions—with outpatient care. Some hospitalists are using practice simulations and training strategies; others have implemented medication reconciliation checks at every discharge, checklists and other communication strategies, team-based quality-improvement (QI) initiatives, and new technologies to enhance and streamline communication. Some interventions follow the patient from the hospital to the community physician with a phone call, follow-up clinic, or other contact; others aim to empower the patient to be a better self-advocate. But for hospitalists, the challenge is to communicate the right amount of transfer information to the right receiver at the right time.
No matter the technique, the goal is the same: Improve the handoff and discharge process in a way that promotes efficiency and patient safety. And hospitalists are at the forefront of the changing landscape of care transitions.
Under the Microscope
Care transitions of all kinds are under the magnifying glass of national healthcare reform, with growing recognition of the need to make care safer and reduce the preventable, costly hospital readmissions caused by incomplete handoffs. Care transitions for hospitalists include internal handoffs, both at daily shift changes and at service changes when an outgoing provider is leaving after a period of consecutive daily shifts. These typically involve a sign-out process and face-to-face encounter, with some kind of written backup. One teaching institution reported that such handoffs take place 4,000 times per day in the hospital, or 1.6 million times per year.2
—Arpana Vidyarthi, MD, University of California at San Francisco
Geographical transitions can be from one floor or department to another, or out the hospital door to another facility or home. Transitions typically involve a discharge process and a written discharge summary. Care transitions also include hospital admissions, which put the hospitalist in the role of handoff receiver rather than initiator, plus a variety of other transitions involving nurses, physician extenders, and other practitioners.
Each transition is a major decision point in the course of a patient’s hospitalization; each transition also presents a time of heightened vulnerability (e.g., potential communication breakdowns, medication errors, patient anxiety or confusion, etc.). In fact, according to a Transitions of Care Consensus Policy Statement published in 2009 by SHM and five other medical societies, handoffs are ubiquitous in HM, with significant patient safety and quality deficiencies in handoffs existing in the current system.3
Poor communication at the time of handoff has been implicated in near-misses and adverse events in a variety of healthcare contexts, including 70% of hospital sentinel events studied by The Joint Commission, which named standardized handoffs (with an opportunity for interactive communication) as a National Patient Safety Goal in 2006.4 The federal government is studying care transitions, supporting demonstration projects for Medicare enrollees, and including readmission rates in national hospital report card data.
“Transitions of care and handoffs are a huge focus right now because of the increased fragmentation of care in the United States. Hospitalists are in charge of a greater percentage of hospitalized patients, which means more coordination of care is needed,” says Vineet Arora, MD, MA, FHM, assistant professor of medicine and associate director of the internal-medicine residency at the University of Chicago, and chair of the SHM task force on handoffs.
Inadequate communication and poor care transitions can undermine hospitalists’ best care-planning efforts, erode patients’ and families’ confidence and satisfaction with hospital care, and leave primary-care physicians (PCPs) feeling unsatisfied with the relationship. As many as 1 in 5 Medicare beneficiary hospitalizations result in a readmission within 30 days, and while not all of these are preventable, far too many are.5 Another prospective cohort study found that 1 in 5 patients discharged from the hospital to the home experienced an adverse event within three weeks of discharge.6 Complex comorbidities, advanced age, unknown PCP, and limited healthcare literacy present hospitalists with extremely difficult transitions.
Patient safety and cost control are the linchpins to national efforts to improve transitions of care. Dr. Arora recently coauthored an original research paper, which will be published in the Journal of Hospital Medicine in September, showing older hospitalized patients are twice as likely to report problems after discharge if their PCPs were not aware they were hospitalized.
“With escalating healthcare costs, people are looking at ways to save money and reduce redundant care,” Dr. Arora explains, pointing out, as an example, repeated tests resulting from inadequate communication between healthcare providers.
The System Must Change
“All of the effort we put into saving someone’s life—the years of experience, training, medical school, and residency—all of it comes to bear on that hospitalized patient. And it can all be unraveled at the time of discharge if it’s not handled properly,” says Arpana Vidyarthi, MD, a hospitalist and director of quality at the University of California at San Francisco.
Dr. Vidyarthi views in-hospital and discharge transitions as integrally related. “The analysis is similar, even if different techniques may be needed,” she says, adding that, fundamentally, it involves having a system that allows people—or forces them—to do the “right thing.”
That’s why achieving effective care transitions will require more than just a standardized tool or process, Dr. Vidyarthi says. “This is about understanding the ways people communicate and finding ways to train them to communicate better,” she says. “The problem we have is not a lack of information, but how to communicate what, to whom, and when.”
What’s really needed, Dr. Vidyarthi says, is a hospital’s commitment to more effective transitions and its hospitalists’ leadership in driving a comprehensive, multidisciplinary, team- and evidence-based QI process. The new process should be a QI-based solution to a hospital’s care-transitions issues. “Before you can standardize your process, you need to understand it,” she says. “This is a complex problem, and it needs a multifaceted solution. But this lies squarely within the hospitalist arena. We’re part of everything that happens in the hospital.
—Anuj Dalal, MD, Brigham and Women’s Hospital, Boston
Hospital administrators are looking to HM to solve transition and readmission problems now, says Tina Budnitz, MPH, BOOST Project Director (Better Outcomes for Older Adults through Safe Transitions). She expects the scrutiny from the C-suite, legislators, and watchdog groups to increase as the spotlight continues to shine on the healthcare system.
“Any hospitalist can act as a leader in their institution,” Budnitz says. “Be a change agent, pull a group together, and start asking questions: Do we have safe care-transitions practices and processes in place? Just by asking the right question, you can be a catalyst for the system.”
Budnitz also emphasizes the importance of teamwork in the hospital setting. “How can I help my teammates? What am I communicating to the nurses on rounds?” she says. “Can you initiate dialogue with your outpatient medical groups: ‘These faxes we’re sending you—is that information getting to you in ways and times that are helpful? And, by the way, when your patient is admitted, this information would really help me.’ ”
Innovative Strategies
One of the most important initiatives responding to concerns about care transitions is Project BOOST (www.hos pitalmedicine.org/BOOST), a comprehensive toolkit for improving a hospital’s transitions of care. The project aims to build a national consensus for best practices in transitions; collaborate with representatives from the Agency for Healthcare Research and Quality (AHRQ), the Centers for Medicare and Medicaid Services (CMS), and the Joint Commission; and develop a national resource library, Budnitz says.
“Project BOOST not only puts forth best practices for admitting patients, planning for discharge, and then doing the discharge, it also helps show facilities how to change their systems, with resources and tools for analyzing and re-engineering the system,” she says. “Sites get one-to-one assistance from a mentor.”
Six hospitals signed on to the pilot program in 2008; 24 more joined last year. In January, SHM announced a collaborative with the University of Michigan and Blue Cross Blue Shield of Michigan for 15 Michigan hospitals to receive training and mentorship starting in May. And last month, SHM and the California HealthCare Foundation announced a Project BOOST initiative for 20 of the health system’s hospitals (see “California Dreamin’”, p. 6). Other free resources offered on the BOOST Web portal include clinical, data collection, and project management tools. SHM also has a DVD that explains how to use the “teachback” method to improve communication with patients.
Jennifer Myers, MD, FHM, assistant professor of clinical medicine and patient-safety officer at the Hospital of the University of Pennsylvania in Philadelphia, is a Project BOOST participant who spearheaded a process change to improve the quality of her facility’s discharge summary, along with accompanying resident education.7 The discharge summary recently was integrated with the hospital’s electronic health record (EHR) system.
“We’ve gone from dictating the discharge summary to an electronic version completed by the hospitalist, with prompts for key components of the summary, which allows us to create summaries more efficiently—ideally on the day of discharge, but usually within 48 hours,” Dr. Myers says. “We previously researched whether teaching made a difference in the quality of discharges; we found that it did. So we look forward to standardizing our teaching approach around this important topic for all residents.”
Another care-transitions innovation receiving a lot of attention from the government and the private sector is Project RED (Re-Engineered Discharge), led by Brian Jack, MD, vice chair of the department of family medicine at Boston Medical Center. The Project RED research group develops and tests strategies to improve the hospital discharge process to promote patient safety and reduce rehospitalization rates.
“We used re-engineering tools borrowed from other fields, brought together experts from all over the hospital, divided up the whole discharge process, and identified key principles,” Dr. Jack explains. The resulting discharge strategy is reflected in an 11-item checklist of discrete, mutually reinforcing components, which have been shown to reduce rehospitalization rates by 32% while raising patient satisfaction.8 It includes comprehensive discharge and after-hospital plans, a nurse discharge advocate, and a medication reconciliation phone call to the patient. A virtual “patient advocate,” a computerized avatar named Louise, is now being tested. If successful, it will allow patients to interact with a touch-screen teacher of the after-care plan who has time to work at the patient’s pace.
Technology and Transitions
Informatics can be a key player in facilitating care transitions, says Anuj Dalal, MD, a hospitalist and instructor in medicine at Brigham and Women’s Hospital in Boston. He is using one of his hospital’s technological strengths—a well-established, firewall-protected e-mail system—to help improve the discharge process.
“We decided to try to improve awareness of test results pending at the time of discharge,” Dr. Dalal explains. “We created an intervention that automatically triggers an e-mail with the finalized test results to the responsible providers. The intervention creates a loop of communication between the inpatient attending and the PCP. What we hope to show in our research over the next year or two is whether the intervention actually increases awareness of test results by providers.”
One thing to remember is that “all kinds of things can go wrong with care transitions,” no matter the size of the institution, the experience of the staff, or technological limitations, says Vineet Chopra, MD, FACP, a hospitalist at the University of Michigan Health System in Ann Arbor. “The problems of transitions vary from place to place, day to day, time of day, shift changes; and let’s not forget physician extenders and the other members of the healthcare team,” he says. “The more complicated the team, the more complicated the information needing to be handed off becomes.”
Before he joined the group at the university, Dr. Chopra worked at a community hospital, St. Joseph’s Mercy Hospital in Hot Springs, Ark. “It’s hard to come up with a one-size-fits-all solution when there are so many variables,” he says. At the community hospital, “we mandated that the hospitalist call the PCP at the time of discharge. At the academic medical center, we share an EHR with the PCPs and can reach them electronically. We are required to have the discharge summary in the computer before the patient leaves the hospital, and we mandate that hospitalists are reachable by e-mail or phone when they are off.
“I’m not a believer in throwing more technology at problems and just adding more layers of information tools,” Dr. Chopra adds. “Hospitalists who used to carry stethoscopes now also have a clipboard, phone, pager, PDA, and nine different signouts in their pockets. What we want to do is make their life easier. Here, we are looking at technology as a means to do that.”
Dr. Chopra and hospitalist colleague Prasanth Gosineni, MD, have been working with an Ann Arbor tech company called Synaptin to develop a lightweight, mobile client application designed to work on smartphones. Still in pilot testing, it would allow for task-oriented and priority-based messaging in real time and the systematic transfer of important information for the next hospitalist shift.
“You need to be able to share information in a systematic way, but that’s only half of the answer. The other half is the ability to ask specific questions,” Dr. Chopra says. “Technology doesn’t take away from the face-to-face encounter that needs to happen. Nothing will replace face time, but part of the solution is to provide data efficiently and in a way that is easily accessible.”
Dr. Chopra admits that EHR presents both positives and negatives to improved transitions and patient care, “depending on how well it works and what smart features it offers,” he says, “but also recognizing that EHR and other technologies have also taken us farther away from face-to-face exchanges. Some would say that’s part of the problem.”
Handoffs, discharges, and other transitions are ubiquitous in HM—and fraught with the potential for costly and harmful errors. The ideal of an interactive, face-to-face handoff simply is not available for many care transitions. However, hospitalists are challenged to find solutions that will work in their hospitals, with their teams, and their types of patients. Patients and policymakers expect nothing less. TH
Larry Beresford is a freelance writer based in Oakland, Calif.
References
- Payne C, Stein J, Dressler D. Implementation of a structured electronic tool to improve patient handoffs and resident satisfaction. Poster abstract: Internal Medicine 2010, April 21-24, 2010, Toronto.
- Vidyarthi AR. Triple Handoff. AHRQ WebM&M website. Available at: webmm.ahrq.gov/case.aspx? caseID=134. Published May 2006. Accessed May 29, 2010.
- Snow V, Beck D, Budnitz T, et al. Transitions of Care Consensus Policy Statement: American College of Physicians, Society of General Internal Medicine, Society of Hospital Medicine, American Geriatrics Society, American College of Emergency Physicians, and Society for Academic Emergency Medicine. J Hosp Med. 2009;4(6):364-370.
- 2006 National Patient Safety Goals. The Joint Commission website. Available at: www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/06_npsgs.htm. Accessed June 8, 2010.
- Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009; 2:360:1418-1428.
- Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med. 2003;138(3):161-167.
- Myers JS, Jaipaul CK, Kogan JR, Krekun S, Bellini LM, Shea JA. Are discharge summaries teachable? The effects of a discharge summary curriculum on the quality of discharge summaries in an internal medicine residency program. Acad Med. 2006; 81(10):S5-S8.
- Jack BW, Chetty VK, Anthony D, et al. A reengineered hospital discharge program to decrease rehospitalization: a randomized trial. Ann Intern Med. 2009;150(3):178-187.
- Arora VM, Manjarrez E, Dressler DD, Basaviah P, Halasyamani L, Kripalani S. Hospitalist handoffs: a systematic review and task force recommendations. J Hosp Med. 2009;4(7): 433-440.
- Halasyamani L, Kripalani S, Coleman E, et al. Transition of care for hospitalized elderly patients—development of a discharge checklist for hospitalists. J Hosp Med. 2006;1(6):354-360.
- Schnipper JL, Kirwin JL, Cotugno MC, et al. Role of pharmacist counseling in preventing adverse drug events after hospitalization. Arch Int Med. 2006;166(5):565-571.
- Dudas V, Bookwalter T, Kerr KM, Pantilat SZ. The impact of follow-up telephone calls to patients after hospitalization. Am J Med. 2001;111(9B): 26S-30S.
California Dreamin’
Project BOOST, SHM’s popular mentorship program designed to help hospitals reduce readmissions, is headed to the most populous state in the country. In a joint venture with the California HealthCare Foundation, Project BOOST (Better Outcomes for Older Adults through Safe Transitions) will launch a groundbreaking, two-year program in 20 hospitals in the Golden State.
The California HealthCare Founda-tion will cover almost half of the $28,000 in tuition costs for each hospital accepted into the collaborative program. Individual sites will be responsible for the other $14,500.
In year one, hospitals will begin improving their discharge procedures using Project BOOST’s toolkit and one-on-one mentorships with leaders in the field. The second year of the project will focus on training additional mentors in California. The foundation has committed not only to improving outcomes in the first 20 sites, but also building a sustainable infrastructure that will allow gains to quickly spread throughout the state.
Recruiting for the California sites has just begun. Potential applicants can visit www.hospitalmedicine.org/boost for more information.
“California is a microcosm for the challenges and opportunities for hospitalized care in our healthcare system,” says Janet Nagamine, RN, MD, SFHM, program leader for the California BOOST program and an SHM board member. “We are very excited to work with the California HealthCare Foundation, one of the state’s leaders in healthcare quality improvement. … Their support will help California’s hospitals and primary-care physicians [PCPs] safely transition patients from hospital to home during that vulnerable period.”
Project BOOST’s Continued Expansion
The California program will be SHM’s largest state-specific program to date, representing the fourth wave of BOOST’s continued expansion. With the support of the John A. Hartford Foundation, the program began with six pilot sites throughout the country in 2008. In 2009, Hartford funded 24 additional sites.
In January, SHM, the University of Michigan, and Blue Cross Blue Shield of Michigan announced the first state-specific Project BOOST program. The three organizations announced Michigan’s 14 participating sites in May.
Two other hospital sites began implementing Project BOOST on a tuition-based model in May.
Readmission Challenge
Most hospitalists are intimately familiar with the challenges involved with transitions of care. Research in the April 2009 New England Journal of Medicine by Stephen F. Jencks, MD, MPH, Mark V. Williams, MD, FHM, and Eric A. Coleman, MD, MPH, indicates that 1 in 5 hospitalized patients is readmitted to the hospital within a month of their discharge.1
Balancing the three-legged stool of communication between the hospitalist, PCP, and patient can be demanding. For the individual hospitalist or PCP, it requires intense attention to detail, strong communication skills, and patience. For hospitals, safe transitions require a systemic, team-based approach.
But the alternative—continued or increased readmissions after discharge—is even more taxing. The study found that unplanned readmissions cost Medicare $17.4 billion each year, making estimates of the total cost even higher.1
Looking beyond the costs directly associated with readmissions, the study’s authors see the issue as a potential vital sign that could assess overall healthcare quality. “Although the readmission rate is often presented as a measure of the performance of hospitals, it may also be a useful indicator of the performance of our healthcare system,” they write.
The Approach: Gain Traction, Results
Rather than forcing a one-size-fits-all process on every hospital site, Project BOOST provides individual hospitals with the capacity and experience necessary to implement processes that best fit their unique situation.
Project BOOST sites participate in a two-pronged program consisting of a yearlong, one-on-one mentorship with the leaders in the field. It begins with an intensive, two-day conference and the Project BOOST toolkit.
The toolkit includes printed materials and a new DVD for use by hospitalists and other care providers to facilitate communication with patients and caregivers during discharge.
New case studies published by SHM document some of the program’s earliest successes.
At Piedmont Hospital, a 481-bed acute-care hospital near Atlanta, the full implementation of Project BOOST in one hospital unit has improved many of its “vital signs” in comparison with units that have not implemented BOOST, including decreased length of stay and lower 30-day readmissions (see “Piedmont Hospital: Project BOOST unit vs. regular hospital units,” p. 6).
For St. Mary’s Medical Center, a 582-bed community teaching hospital in St. Louis, hospitalists implementing Project BOOST made a major difference in just three months:
Not only did the Project BOOST unit nearly halve 30-day readmissions (7% from 12%), but the program also increased patient satisfaction, to 68% from 52%.
BOOSTing into the Future
Project BOOST benefits haven’t been limited to program sites and their patients. New innovations from the mentored implementation program have led to resources that all hospitals can use.
SHM recently introduced a new DVD and curriculum package that teaches nurses and discharge planners to use the “teachback” method to communicate with patients during the discharge process. It helps ensure that patients fully understand their care plans and post-discharge instructions.
The teachback package is available at the SHM online store (www.hospitalmedicine.org); it is $85 for SHM members and $125 for nonmembers.
SHM has also launched a BOOST data center and a BOOST community site. The data center enables sites to enter, track, and benchmark key outcomes, which can then be evaluated against comparison units at their own hospitals, BOOST averages, and subsets of hospitals with similar characteristics. The BOOST community site facilitates the sharing of ideas and documents between BOOST hospitals.
New funding approaches will help Project BOOST to continue to reach more hospitals. Since its inception, third parties have provided financial resources for the program.
Now, SHM is offering a tuition-based model, open to hospitals nationwide, which is set to begin this fall.
SHM is accepting applications at www.hospitalmedicine.org/boost. TH
Brendon Shank is a freelance writer based in Philadelphia.
Reference
- Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Eng J Med. 2009:360:1418-1428.
Project BOOST, SHM’s popular mentorship program designed to help hospitals reduce readmissions, is headed to the most populous state in the country. In a joint venture with the California HealthCare Foundation, Project BOOST (Better Outcomes for Older Adults through Safe Transitions) will launch a groundbreaking, two-year program in 20 hospitals in the Golden State.
The California HealthCare Founda-tion will cover almost half of the $28,000 in tuition costs for each hospital accepted into the collaborative program. Individual sites will be responsible for the other $14,500.
In year one, hospitals will begin improving their discharge procedures using Project BOOST’s toolkit and one-on-one mentorships with leaders in the field. The second year of the project will focus on training additional mentors in California. The foundation has committed not only to improving outcomes in the first 20 sites, but also building a sustainable infrastructure that will allow gains to quickly spread throughout the state.
Recruiting for the California sites has just begun. Potential applicants can visit www.hospitalmedicine.org/boost for more information.
“California is a microcosm for the challenges and opportunities for hospitalized care in our healthcare system,” says Janet Nagamine, RN, MD, SFHM, program leader for the California BOOST program and an SHM board member. “We are very excited to work with the California HealthCare Foundation, one of the state’s leaders in healthcare quality improvement. … Their support will help California’s hospitals and primary-care physicians [PCPs] safely transition patients from hospital to home during that vulnerable period.”
Project BOOST’s Continued Expansion
The California program will be SHM’s largest state-specific program to date, representing the fourth wave of BOOST’s continued expansion. With the support of the John A. Hartford Foundation, the program began with six pilot sites throughout the country in 2008. In 2009, Hartford funded 24 additional sites.
In January, SHM, the University of Michigan, and Blue Cross Blue Shield of Michigan announced the first state-specific Project BOOST program. The three organizations announced Michigan’s 14 participating sites in May.
Two other hospital sites began implementing Project BOOST on a tuition-based model in May.
Readmission Challenge
Most hospitalists are intimately familiar with the challenges involved with transitions of care. Research in the April 2009 New England Journal of Medicine by Stephen F. Jencks, MD, MPH, Mark V. Williams, MD, FHM, and Eric A. Coleman, MD, MPH, indicates that 1 in 5 hospitalized patients is readmitted to the hospital within a month of their discharge.1
Balancing the three-legged stool of communication between the hospitalist, PCP, and patient can be demanding. For the individual hospitalist or PCP, it requires intense attention to detail, strong communication skills, and patience. For hospitals, safe transitions require a systemic, team-based approach.
But the alternative—continued or increased readmissions after discharge—is even more taxing. The study found that unplanned readmissions cost Medicare $17.4 billion each year, making estimates of the total cost even higher.1
Looking beyond the costs directly associated with readmissions, the study’s authors see the issue as a potential vital sign that could assess overall healthcare quality. “Although the readmission rate is often presented as a measure of the performance of hospitals, it may also be a useful indicator of the performance of our healthcare system,” they write.
The Approach: Gain Traction, Results
Rather than forcing a one-size-fits-all process on every hospital site, Project BOOST provides individual hospitals with the capacity and experience necessary to implement processes that best fit their unique situation.
Project BOOST sites participate in a two-pronged program consisting of a yearlong, one-on-one mentorship with the leaders in the field. It begins with an intensive, two-day conference and the Project BOOST toolkit.
The toolkit includes printed materials and a new DVD for use by hospitalists and other care providers to facilitate communication with patients and caregivers during discharge.
New case studies published by SHM document some of the program’s earliest successes.
At Piedmont Hospital, a 481-bed acute-care hospital near Atlanta, the full implementation of Project BOOST in one hospital unit has improved many of its “vital signs” in comparison with units that have not implemented BOOST, including decreased length of stay and lower 30-day readmissions (see “Piedmont Hospital: Project BOOST unit vs. regular hospital units,” p. 6).
For St. Mary’s Medical Center, a 582-bed community teaching hospital in St. Louis, hospitalists implementing Project BOOST made a major difference in just three months:
Not only did the Project BOOST unit nearly halve 30-day readmissions (7% from 12%), but the program also increased patient satisfaction, to 68% from 52%.
BOOSTing into the Future
Project BOOST benefits haven’t been limited to program sites and their patients. New innovations from the mentored implementation program have led to resources that all hospitals can use.
SHM recently introduced a new DVD and curriculum package that teaches nurses and discharge planners to use the “teachback” method to communicate with patients during the discharge process. It helps ensure that patients fully understand their care plans and post-discharge instructions.
The teachback package is available at the SHM online store (www.hospitalmedicine.org); it is $85 for SHM members and $125 for nonmembers.
SHM has also launched a BOOST data center and a BOOST community site. The data center enables sites to enter, track, and benchmark key outcomes, which can then be evaluated against comparison units at their own hospitals, BOOST averages, and subsets of hospitals with similar characteristics. The BOOST community site facilitates the sharing of ideas and documents between BOOST hospitals.
New funding approaches will help Project BOOST to continue to reach more hospitals. Since its inception, third parties have provided financial resources for the program.
Now, SHM is offering a tuition-based model, open to hospitals nationwide, which is set to begin this fall.
SHM is accepting applications at www.hospitalmedicine.org/boost. TH
Brendon Shank is a freelance writer based in Philadelphia.
Reference
- Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Eng J Med. 2009:360:1418-1428.
Project BOOST, SHM’s popular mentorship program designed to help hospitals reduce readmissions, is headed to the most populous state in the country. In a joint venture with the California HealthCare Foundation, Project BOOST (Better Outcomes for Older Adults through Safe Transitions) will launch a groundbreaking, two-year program in 20 hospitals in the Golden State.
The California HealthCare Founda-tion will cover almost half of the $28,000 in tuition costs for each hospital accepted into the collaborative program. Individual sites will be responsible for the other $14,500.
In year one, hospitals will begin improving their discharge procedures using Project BOOST’s toolkit and one-on-one mentorships with leaders in the field. The second year of the project will focus on training additional mentors in California. The foundation has committed not only to improving outcomes in the first 20 sites, but also building a sustainable infrastructure that will allow gains to quickly spread throughout the state.
Recruiting for the California sites has just begun. Potential applicants can visit www.hospitalmedicine.org/boost for more information.
“California is a microcosm for the challenges and opportunities for hospitalized care in our healthcare system,” says Janet Nagamine, RN, MD, SFHM, program leader for the California BOOST program and an SHM board member. “We are very excited to work with the California HealthCare Foundation, one of the state’s leaders in healthcare quality improvement. … Their support will help California’s hospitals and primary-care physicians [PCPs] safely transition patients from hospital to home during that vulnerable period.”
Project BOOST’s Continued Expansion
The California program will be SHM’s largest state-specific program to date, representing the fourth wave of BOOST’s continued expansion. With the support of the John A. Hartford Foundation, the program began with six pilot sites throughout the country in 2008. In 2009, Hartford funded 24 additional sites.
In January, SHM, the University of Michigan, and Blue Cross Blue Shield of Michigan announced the first state-specific Project BOOST program. The three organizations announced Michigan’s 14 participating sites in May.
Two other hospital sites began implementing Project BOOST on a tuition-based model in May.
Readmission Challenge
Most hospitalists are intimately familiar with the challenges involved with transitions of care. Research in the April 2009 New England Journal of Medicine by Stephen F. Jencks, MD, MPH, Mark V. Williams, MD, FHM, and Eric A. Coleman, MD, MPH, indicates that 1 in 5 hospitalized patients is readmitted to the hospital within a month of their discharge.1
Balancing the three-legged stool of communication between the hospitalist, PCP, and patient can be demanding. For the individual hospitalist or PCP, it requires intense attention to detail, strong communication skills, and patience. For hospitals, safe transitions require a systemic, team-based approach.
But the alternative—continued or increased readmissions after discharge—is even more taxing. The study found that unplanned readmissions cost Medicare $17.4 billion each year, making estimates of the total cost even higher.1
Looking beyond the costs directly associated with readmissions, the study’s authors see the issue as a potential vital sign that could assess overall healthcare quality. “Although the readmission rate is often presented as a measure of the performance of hospitals, it may also be a useful indicator of the performance of our healthcare system,” they write.
The Approach: Gain Traction, Results
Rather than forcing a one-size-fits-all process on every hospital site, Project BOOST provides individual hospitals with the capacity and experience necessary to implement processes that best fit their unique situation.
Project BOOST sites participate in a two-pronged program consisting of a yearlong, one-on-one mentorship with the leaders in the field. It begins with an intensive, two-day conference and the Project BOOST toolkit.
The toolkit includes printed materials and a new DVD for use by hospitalists and other care providers to facilitate communication with patients and caregivers during discharge.
New case studies published by SHM document some of the program’s earliest successes.
At Piedmont Hospital, a 481-bed acute-care hospital near Atlanta, the full implementation of Project BOOST in one hospital unit has improved many of its “vital signs” in comparison with units that have not implemented BOOST, including decreased length of stay and lower 30-day readmissions (see “Piedmont Hospital: Project BOOST unit vs. regular hospital units,” p. 6).
For St. Mary’s Medical Center, a 582-bed community teaching hospital in St. Louis, hospitalists implementing Project BOOST made a major difference in just three months:
Not only did the Project BOOST unit nearly halve 30-day readmissions (7% from 12%), but the program also increased patient satisfaction, to 68% from 52%.
BOOSTing into the Future
Project BOOST benefits haven’t been limited to program sites and their patients. New innovations from the mentored implementation program have led to resources that all hospitals can use.
SHM recently introduced a new DVD and curriculum package that teaches nurses and discharge planners to use the “teachback” method to communicate with patients during the discharge process. It helps ensure that patients fully understand their care plans and post-discharge instructions.
The teachback package is available at the SHM online store (www.hospitalmedicine.org); it is $85 for SHM members and $125 for nonmembers.
SHM has also launched a BOOST data center and a BOOST community site. The data center enables sites to enter, track, and benchmark key outcomes, which can then be evaluated against comparison units at their own hospitals, BOOST averages, and subsets of hospitals with similar characteristics. The BOOST community site facilitates the sharing of ideas and documents between BOOST hospitals.
New funding approaches will help Project BOOST to continue to reach more hospitals. Since its inception, third parties have provided financial resources for the program.
Now, SHM is offering a tuition-based model, open to hospitals nationwide, which is set to begin this fall.
SHM is accepting applications at www.hospitalmedicine.org/boost. TH
Brendon Shank is a freelance writer based in Philadelphia.
Reference
- Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Eng J Med. 2009:360:1418-1428.
Market Watch
New Drugs, Indications, Dosage Forms, and Approval Recommendations
- Acetaminophen intravenous (Ofirmev) received a complete response letter in February from the FDA related to facility manufacturing deficiencies. The FDA did not cite any safety or efficacy issues and is not requiring any additional studies to be done prior to approval.1 The third-party manufacturer has submitted its response to the FDA and is ready to resubmit their new drug application (NDA) for this agent. It is being investigated to treat fever and pain in adults and children.2
- Ciprofloxacin dry powder inhaler (DPI) has received orphan drug status from the FDA for treating pulmonary infections in cystic fibrosis (CF) patients.3,4 It is in clinical trials to determine if it can improve pulmonary function in CF patients with Pseudomonas aeruginosa infections.
- Carglumic acid (Carbaglu) has been approved by the FDA to treat the metabolic disorder N-acetylglutamate synthetase (NAGS) deficiency.5 NAGS deficiency is an extremely rare genetic disorder that presents shortly after birth. It results in hyperammonemia, and can be fatal if not rapidly detected and managed. Carglumic acid treats the hyperammonemia within three days, with a lowering of the ammonia level within 24 hours. In clinical trials, a small number of patients (n=23) received the drug from six months to 21 years; the majority of patients were able to maintain normal ammonia levels long-term with continued treatment. It is recommended that carglumic acid only be administered by physicians who have experience dealing with metabolic disorders. The starting dose is between 100 mg/kg/day and 250 mg/kg/day for treatment of acute hyperammonemia. Using other agents to lower the ammonia level during acute episodes is recommended. Dosing should be based on the ammonia level and the patient’s symptoms.
- CK-2017357 has received orphan drug status for treating amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease.6
- Desirudin injection (Iprivask), a direct thrombin inhibitor, has been approved by the FDA for the prevention of DVT.7 In clinical trials, it was superior to enoxaparin and unfractionated heparin for preventing proximal DVT and prevention of major venous thromboembolic events following elective hip replacement surgery. Desirudin is administered as a fixed subcutaneous dose. It does not cause thrombocytopenia, is relatively short-acting, and is easy to monitor. Some of the adverse reactions in clinical trials were thrombosis, hypotension, lower-extremity edema, fever, decreased hemoglobin level, and hematuria.8 Also known as Revasc, this medication has been available in Europe for more than 10 years.
- Doxepin tablets (Silenor) have been approved by the FDA for the treatment of short-term and chronic insomnia distinguished by difficulty with sleep maintenance in adults and elderly patients.9 Sleep maintenance includes difficulty staying asleep, waking up too much or too early, and not being able to fall back asleep. In clinical trials, adverse reactions were similar to placebo, there was a low-therapy discontinuation rate, and no evidence of amnesia, tolerance, or complex sleep behaviors such as sleep eating or sleep driving.10 It will be available in 3-mg and 6-mg tablets. It is not designated as a controlled substance.
- GVAX pancreas vaccine has received orphan drug status as a potential treatment for pancreatic cancer.11 It also is being investigated for other cancers, including those of the breast and for leukemias.
- Ritonavir (Norvir) has been approved by the FDA in a new formulation, which is heat-stable and can be stored at room temperature rather than in the refrigerator.12 The rate of drug absorption with the new formulation is different but does not require a dosage change.
- Somatropin [rDNA origin] prefilled injection pen (Norditropin FlexPro) has been approved by the FDA to treat adults and children with growth hormone disorders.13 The pen has an audible click and does not require any reconstitution or cartridge loading. After initial use, the pen can be left at room temperature for up to three weeks without worry of drug degradation.
Pipeline
- Agalsidase (Replagal) has received fast-track status from the FDA for treating Fabry disease.14 It is an enzyme replacement therapy.
- Exenatide LAR (Bydureon), the once-weekly version of exenatide (Byetta), is in final discussions at the FDA. The FDA has asked for additional information related to the product label, risk mitigation, and manufacturing, which the manufacturer is addressing.15
- Insulin powder for inhalation, ultra-rapid-acting (Afrezza), has been reviewed by the FDA, and the agency has requested additional information related to safety and labeling.16
- A combination therapy of saxagliptin/metformin has been submitted to the FDA as a once-daily treatment of Type 2 diabetes mellitus as an adjunct to diet in adults who cannot adequately control their diabetes on metformin monotherapy, or in treatment-naïve patients.17
- Vilanterol/fluticasone is a combination of the inhaled corticosteroid fluticasone and the long-acting beta-agonist (LABA) vilanterol, which is currently in Phase 3 clinical trials for treating asthma.18 The trial will compare the combination’s efficacy and safety to fluticasone/salmeterol (Advair). TH
Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.
References
- Cadence pharmaceuticals receives complete response letter from FDA for intravenous acetaminophen NDA. Cadence Pharmaceuticals website. Available at: http://cadx.client.shareholder.com/releasedetail.cfm?ReleaseID=444303. Accessed March 23, 2010.
- Cadence pharmaceuticals reports fourth quarter and full year 2009 financial results. Cadence Pharmaceuticals website. Available at: http://files.shareholder.com/downloads/CADX/874963043x0x359109/1cf00f72-0872-4d4e-b27d-bde1c03d625a/CADX_News_2010_3_15_General_Releases.pdf. Accessed March 23, 2010.
- Bayer lung infection drug gets orphan status. Forbes website. Available at: http://www.forbes.com/feeds/ap/2010/03/11/business-energy-us-bayer-healthcare-orphan-drug_7427368.html. Accessed March 23, 2010.
- FDA grants orphan status for Bayer’s ciprofloxacin for cystic fibrosis. The Pharma Letter website. Available at: http://www.thepharmaletter.com/file/4e4fb33313eddf122cdb730e3ea71840/fda-grants-orphan-status-for-bayers-ciprofloxacin-for-cystic-fibrosis.html. Accessed March 23, 2010.
- Burgess S. FDA approves drug to treat condition that causes elevated ammonia levels. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm205150.htm. Accessed March 23, 2010.
- UPDATE 1: Cytokinetics’ Lou Gehrig’s drug gets orphan status. Reuters website. Available at: http://www.reuters.com/assets/print?aid=USSGE6290J820100310. Accessed March 23, 2010.
- Iprivask available for prevention of deep vein thrombosis. Monthly Prescribing Reference website. Available at: http://www.empr.com/iprivask-available-for-prevention-of-deep-vein-thrombosis/article/164779/. Accessed March 23, 2010.
- First direct thrombin inhibitor for DVT prevention now available from Canyon Pharmaceuticals. Canyon Pharmaceuticals website. Available at: http://www.canyonpharma.com/newsexpand.aspx?id=7. Accessed March 23, 2010.
- FDA approves Silenor. Drugs.com website. Available at: http://www.drugs.com/newdrugs/somaxon-announces-fda-approval-silenor-doxepin-insomnia-2070.html?printable=1. Accessed March 23, 2010.
- UPDATE 1: Somaxon gets FDA nod for insomnia drug, shares soar. Reuters website. Available at: http://www.reuters.com/assets/print?aid=USSGE62H0KI20100318. Accessed March 21, 2010.
- BioSante announces FDA orphan drug designation for GVAX pancreatic cancer vaccine. The New York Times website. Available at: http://markets.on.nytimes.com/research/stocks/news/press_release.asp?docTag=201003150755BIZWIRE_USPRX____BW5298&feedID=600&press_symbol=64917. Accessed March 23, 2010.
- Abbott receives U.S. FDA approval for heat-stable Norvir (ritonavir) tablets. Abbott website. Available at: http://www.abbott.com/global/url/pressRelease/en_US/60.5:5/Press_Release_0820.htm. Accessed March 23, 2010.
- Novo Nordisk receives FDA approval for Norditropin FlexPro for growth hormone treatment. Novo Nordisk website. Available at: http://press.novonordisk-us.com/index.php?s=43&item=239. Accessed March 23, 2010.
- Dane L. Shire receives FDA fast-track designation for Replagal. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=97AF48EBA7054EF0857F055877E82B2C&logRowId=352323. Accessed March 23, 2010.
- Amylin shares up on FDA response for diabetes drug. Forbes website. Available at: http://www.forbes.com/feeds/ap/2010/03/15/business-health-care-us-amylin-mover_7435579.html. Accessed March 23, 2010.
- Russell J. MannKind drug fails to win FDA approval. Los Angeles Business Journal website. Available at: http://labusinessjournal.com/article.asp?aid=4998235.0597195.1894204.8500584.7421642.713. Accessed March 23, 2010.
- U.S. Food and Drug Administration accepts NDA for once-daily fixed dose combination of Onglyza (saxagliptin) and extended-release metformin for the treatment of type 2 diabetes mellitus in adults. AstraZeneca website. Available at: http://www.astrazeneca-us.com/about-astrazeneca-us/newsroom/product/8804120?itemId=8804120#. Accessed March 23, 2010.
- Dennis M. GlaxoSmithKline begins late-stage clinical programme for asthma drug Relovair. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=E256469FBD8F4A2F80C5DD3E844CC1E1&logRowId=356423. Accessed March 23, 2010.
New Drugs, Indications, Dosage Forms, and Approval Recommendations
- Acetaminophen intravenous (Ofirmev) received a complete response letter in February from the FDA related to facility manufacturing deficiencies. The FDA did not cite any safety or efficacy issues and is not requiring any additional studies to be done prior to approval.1 The third-party manufacturer has submitted its response to the FDA and is ready to resubmit their new drug application (NDA) for this agent. It is being investigated to treat fever and pain in adults and children.2
- Ciprofloxacin dry powder inhaler (DPI) has received orphan drug status from the FDA for treating pulmonary infections in cystic fibrosis (CF) patients.3,4 It is in clinical trials to determine if it can improve pulmonary function in CF patients with Pseudomonas aeruginosa infections.
- Carglumic acid (Carbaglu) has been approved by the FDA to treat the metabolic disorder N-acetylglutamate synthetase (NAGS) deficiency.5 NAGS deficiency is an extremely rare genetic disorder that presents shortly after birth. It results in hyperammonemia, and can be fatal if not rapidly detected and managed. Carglumic acid treats the hyperammonemia within three days, with a lowering of the ammonia level within 24 hours. In clinical trials, a small number of patients (n=23) received the drug from six months to 21 years; the majority of patients were able to maintain normal ammonia levels long-term with continued treatment. It is recommended that carglumic acid only be administered by physicians who have experience dealing with metabolic disorders. The starting dose is between 100 mg/kg/day and 250 mg/kg/day for treatment of acute hyperammonemia. Using other agents to lower the ammonia level during acute episodes is recommended. Dosing should be based on the ammonia level and the patient’s symptoms.
- CK-2017357 has received orphan drug status for treating amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease.6
- Desirudin injection (Iprivask), a direct thrombin inhibitor, has been approved by the FDA for the prevention of DVT.7 In clinical trials, it was superior to enoxaparin and unfractionated heparin for preventing proximal DVT and prevention of major venous thromboembolic events following elective hip replacement surgery. Desirudin is administered as a fixed subcutaneous dose. It does not cause thrombocytopenia, is relatively short-acting, and is easy to monitor. Some of the adverse reactions in clinical trials were thrombosis, hypotension, lower-extremity edema, fever, decreased hemoglobin level, and hematuria.8 Also known as Revasc, this medication has been available in Europe for more than 10 years.
- Doxepin tablets (Silenor) have been approved by the FDA for the treatment of short-term and chronic insomnia distinguished by difficulty with sleep maintenance in adults and elderly patients.9 Sleep maintenance includes difficulty staying asleep, waking up too much or too early, and not being able to fall back asleep. In clinical trials, adverse reactions were similar to placebo, there was a low-therapy discontinuation rate, and no evidence of amnesia, tolerance, or complex sleep behaviors such as sleep eating or sleep driving.10 It will be available in 3-mg and 6-mg tablets. It is not designated as a controlled substance.
- GVAX pancreas vaccine has received orphan drug status as a potential treatment for pancreatic cancer.11 It also is being investigated for other cancers, including those of the breast and for leukemias.
- Ritonavir (Norvir) has been approved by the FDA in a new formulation, which is heat-stable and can be stored at room temperature rather than in the refrigerator.12 The rate of drug absorption with the new formulation is different but does not require a dosage change.
- Somatropin [rDNA origin] prefilled injection pen (Norditropin FlexPro) has been approved by the FDA to treat adults and children with growth hormone disorders.13 The pen has an audible click and does not require any reconstitution or cartridge loading. After initial use, the pen can be left at room temperature for up to three weeks without worry of drug degradation.
Pipeline
- Agalsidase (Replagal) has received fast-track status from the FDA for treating Fabry disease.14 It is an enzyme replacement therapy.
- Exenatide LAR (Bydureon), the once-weekly version of exenatide (Byetta), is in final discussions at the FDA. The FDA has asked for additional information related to the product label, risk mitigation, and manufacturing, which the manufacturer is addressing.15
- Insulin powder for inhalation, ultra-rapid-acting (Afrezza), has been reviewed by the FDA, and the agency has requested additional information related to safety and labeling.16
- A combination therapy of saxagliptin/metformin has been submitted to the FDA as a once-daily treatment of Type 2 diabetes mellitus as an adjunct to diet in adults who cannot adequately control their diabetes on metformin monotherapy, or in treatment-naïve patients.17
- Vilanterol/fluticasone is a combination of the inhaled corticosteroid fluticasone and the long-acting beta-agonist (LABA) vilanterol, which is currently in Phase 3 clinical trials for treating asthma.18 The trial will compare the combination’s efficacy and safety to fluticasone/salmeterol (Advair). TH
Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.
References
- Cadence pharmaceuticals receives complete response letter from FDA for intravenous acetaminophen NDA. Cadence Pharmaceuticals website. Available at: http://cadx.client.shareholder.com/releasedetail.cfm?ReleaseID=444303. Accessed March 23, 2010.
- Cadence pharmaceuticals reports fourth quarter and full year 2009 financial results. Cadence Pharmaceuticals website. Available at: http://files.shareholder.com/downloads/CADX/874963043x0x359109/1cf00f72-0872-4d4e-b27d-bde1c03d625a/CADX_News_2010_3_15_General_Releases.pdf. Accessed March 23, 2010.
- Bayer lung infection drug gets orphan status. Forbes website. Available at: http://www.forbes.com/feeds/ap/2010/03/11/business-energy-us-bayer-healthcare-orphan-drug_7427368.html. Accessed March 23, 2010.
- FDA grants orphan status for Bayer’s ciprofloxacin for cystic fibrosis. The Pharma Letter website. Available at: http://www.thepharmaletter.com/file/4e4fb33313eddf122cdb730e3ea71840/fda-grants-orphan-status-for-bayers-ciprofloxacin-for-cystic-fibrosis.html. Accessed March 23, 2010.
- Burgess S. FDA approves drug to treat condition that causes elevated ammonia levels. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm205150.htm. Accessed March 23, 2010.
- UPDATE 1: Cytokinetics’ Lou Gehrig’s drug gets orphan status. Reuters website. Available at: http://www.reuters.com/assets/print?aid=USSGE6290J820100310. Accessed March 23, 2010.
- Iprivask available for prevention of deep vein thrombosis. Monthly Prescribing Reference website. Available at: http://www.empr.com/iprivask-available-for-prevention-of-deep-vein-thrombosis/article/164779/. Accessed March 23, 2010.
- First direct thrombin inhibitor for DVT prevention now available from Canyon Pharmaceuticals. Canyon Pharmaceuticals website. Available at: http://www.canyonpharma.com/newsexpand.aspx?id=7. Accessed March 23, 2010.
- FDA approves Silenor. Drugs.com website. Available at: http://www.drugs.com/newdrugs/somaxon-announces-fda-approval-silenor-doxepin-insomnia-2070.html?printable=1. Accessed March 23, 2010.
- UPDATE 1: Somaxon gets FDA nod for insomnia drug, shares soar. Reuters website. Available at: http://www.reuters.com/assets/print?aid=USSGE62H0KI20100318. Accessed March 21, 2010.
- BioSante announces FDA orphan drug designation for GVAX pancreatic cancer vaccine. The New York Times website. Available at: http://markets.on.nytimes.com/research/stocks/news/press_release.asp?docTag=201003150755BIZWIRE_USPRX____BW5298&feedID=600&press_symbol=64917. Accessed March 23, 2010.
- Abbott receives U.S. FDA approval for heat-stable Norvir (ritonavir) tablets. Abbott website. Available at: http://www.abbott.com/global/url/pressRelease/en_US/60.5:5/Press_Release_0820.htm. Accessed March 23, 2010.
- Novo Nordisk receives FDA approval for Norditropin FlexPro for growth hormone treatment. Novo Nordisk website. Available at: http://press.novonordisk-us.com/index.php?s=43&item=239. Accessed March 23, 2010.
- Dane L. Shire receives FDA fast-track designation for Replagal. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=97AF48EBA7054EF0857F055877E82B2C&logRowId=352323. Accessed March 23, 2010.
- Amylin shares up on FDA response for diabetes drug. Forbes website. Available at: http://www.forbes.com/feeds/ap/2010/03/15/business-health-care-us-amylin-mover_7435579.html. Accessed March 23, 2010.
- Russell J. MannKind drug fails to win FDA approval. Los Angeles Business Journal website. Available at: http://labusinessjournal.com/article.asp?aid=4998235.0597195.1894204.8500584.7421642.713. Accessed March 23, 2010.
- U.S. Food and Drug Administration accepts NDA for once-daily fixed dose combination of Onglyza (saxagliptin) and extended-release metformin for the treatment of type 2 diabetes mellitus in adults. AstraZeneca website. Available at: http://www.astrazeneca-us.com/about-astrazeneca-us/newsroom/product/8804120?itemId=8804120#. Accessed March 23, 2010.
- Dennis M. GlaxoSmithKline begins late-stage clinical programme for asthma drug Relovair. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=E256469FBD8F4A2F80C5DD3E844CC1E1&logRowId=356423. Accessed March 23, 2010.
New Drugs, Indications, Dosage Forms, and Approval Recommendations
- Acetaminophen intravenous (Ofirmev) received a complete response letter in February from the FDA related to facility manufacturing deficiencies. The FDA did not cite any safety or efficacy issues and is not requiring any additional studies to be done prior to approval.1 The third-party manufacturer has submitted its response to the FDA and is ready to resubmit their new drug application (NDA) for this agent. It is being investigated to treat fever and pain in adults and children.2
- Ciprofloxacin dry powder inhaler (DPI) has received orphan drug status from the FDA for treating pulmonary infections in cystic fibrosis (CF) patients.3,4 It is in clinical trials to determine if it can improve pulmonary function in CF patients with Pseudomonas aeruginosa infections.
- Carglumic acid (Carbaglu) has been approved by the FDA to treat the metabolic disorder N-acetylglutamate synthetase (NAGS) deficiency.5 NAGS deficiency is an extremely rare genetic disorder that presents shortly after birth. It results in hyperammonemia, and can be fatal if not rapidly detected and managed. Carglumic acid treats the hyperammonemia within three days, with a lowering of the ammonia level within 24 hours. In clinical trials, a small number of patients (n=23) received the drug from six months to 21 years; the majority of patients were able to maintain normal ammonia levels long-term with continued treatment. It is recommended that carglumic acid only be administered by physicians who have experience dealing with metabolic disorders. The starting dose is between 100 mg/kg/day and 250 mg/kg/day for treatment of acute hyperammonemia. Using other agents to lower the ammonia level during acute episodes is recommended. Dosing should be based on the ammonia level and the patient’s symptoms.
- CK-2017357 has received orphan drug status for treating amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease.6
- Desirudin injection (Iprivask), a direct thrombin inhibitor, has been approved by the FDA for the prevention of DVT.7 In clinical trials, it was superior to enoxaparin and unfractionated heparin for preventing proximal DVT and prevention of major venous thromboembolic events following elective hip replacement surgery. Desirudin is administered as a fixed subcutaneous dose. It does not cause thrombocytopenia, is relatively short-acting, and is easy to monitor. Some of the adverse reactions in clinical trials were thrombosis, hypotension, lower-extremity edema, fever, decreased hemoglobin level, and hematuria.8 Also known as Revasc, this medication has been available in Europe for more than 10 years.
- Doxepin tablets (Silenor) have been approved by the FDA for the treatment of short-term and chronic insomnia distinguished by difficulty with sleep maintenance in adults and elderly patients.9 Sleep maintenance includes difficulty staying asleep, waking up too much or too early, and not being able to fall back asleep. In clinical trials, adverse reactions were similar to placebo, there was a low-therapy discontinuation rate, and no evidence of amnesia, tolerance, or complex sleep behaviors such as sleep eating or sleep driving.10 It will be available in 3-mg and 6-mg tablets. It is not designated as a controlled substance.
- GVAX pancreas vaccine has received orphan drug status as a potential treatment for pancreatic cancer.11 It also is being investigated for other cancers, including those of the breast and for leukemias.
- Ritonavir (Norvir) has been approved by the FDA in a new formulation, which is heat-stable and can be stored at room temperature rather than in the refrigerator.12 The rate of drug absorption with the new formulation is different but does not require a dosage change.
- Somatropin [rDNA origin] prefilled injection pen (Norditropin FlexPro) has been approved by the FDA to treat adults and children with growth hormone disorders.13 The pen has an audible click and does not require any reconstitution or cartridge loading. After initial use, the pen can be left at room temperature for up to three weeks without worry of drug degradation.
Pipeline
- Agalsidase (Replagal) has received fast-track status from the FDA for treating Fabry disease.14 It is an enzyme replacement therapy.
- Exenatide LAR (Bydureon), the once-weekly version of exenatide (Byetta), is in final discussions at the FDA. The FDA has asked for additional information related to the product label, risk mitigation, and manufacturing, which the manufacturer is addressing.15
- Insulin powder for inhalation, ultra-rapid-acting (Afrezza), has been reviewed by the FDA, and the agency has requested additional information related to safety and labeling.16
- A combination therapy of saxagliptin/metformin has been submitted to the FDA as a once-daily treatment of Type 2 diabetes mellitus as an adjunct to diet in adults who cannot adequately control their diabetes on metformin monotherapy, or in treatment-naïve patients.17
- Vilanterol/fluticasone is a combination of the inhaled corticosteroid fluticasone and the long-acting beta-agonist (LABA) vilanterol, which is currently in Phase 3 clinical trials for treating asthma.18 The trial will compare the combination’s efficacy and safety to fluticasone/salmeterol (Advair). TH
Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.
References
- Cadence pharmaceuticals receives complete response letter from FDA for intravenous acetaminophen NDA. Cadence Pharmaceuticals website. Available at: http://cadx.client.shareholder.com/releasedetail.cfm?ReleaseID=444303. Accessed March 23, 2010.
- Cadence pharmaceuticals reports fourth quarter and full year 2009 financial results. Cadence Pharmaceuticals website. Available at: http://files.shareholder.com/downloads/CADX/874963043x0x359109/1cf00f72-0872-4d4e-b27d-bde1c03d625a/CADX_News_2010_3_15_General_Releases.pdf. Accessed March 23, 2010.
- Bayer lung infection drug gets orphan status. Forbes website. Available at: http://www.forbes.com/feeds/ap/2010/03/11/business-energy-us-bayer-healthcare-orphan-drug_7427368.html. Accessed March 23, 2010.
- FDA grants orphan status for Bayer’s ciprofloxacin for cystic fibrosis. The Pharma Letter website. Available at: http://www.thepharmaletter.com/file/4e4fb33313eddf122cdb730e3ea71840/fda-grants-orphan-status-for-bayers-ciprofloxacin-for-cystic-fibrosis.html. Accessed March 23, 2010.
- Burgess S. FDA approves drug to treat condition that causes elevated ammonia levels. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm205150.htm. Accessed March 23, 2010.
- UPDATE 1: Cytokinetics’ Lou Gehrig’s drug gets orphan status. Reuters website. Available at: http://www.reuters.com/assets/print?aid=USSGE6290J820100310. Accessed March 23, 2010.
- Iprivask available for prevention of deep vein thrombosis. Monthly Prescribing Reference website. Available at: http://www.empr.com/iprivask-available-for-prevention-of-deep-vein-thrombosis/article/164779/. Accessed March 23, 2010.
- First direct thrombin inhibitor for DVT prevention now available from Canyon Pharmaceuticals. Canyon Pharmaceuticals website. Available at: http://www.canyonpharma.com/newsexpand.aspx?id=7. Accessed March 23, 2010.
- FDA approves Silenor. Drugs.com website. Available at: http://www.drugs.com/newdrugs/somaxon-announces-fda-approval-silenor-doxepin-insomnia-2070.html?printable=1. Accessed March 23, 2010.
- UPDATE 1: Somaxon gets FDA nod for insomnia drug, shares soar. Reuters website. Available at: http://www.reuters.com/assets/print?aid=USSGE62H0KI20100318. Accessed March 21, 2010.
- BioSante announces FDA orphan drug designation for GVAX pancreatic cancer vaccine. The New York Times website. Available at: http://markets.on.nytimes.com/research/stocks/news/press_release.asp?docTag=201003150755BIZWIRE_USPRX____BW5298&feedID=600&press_symbol=64917. Accessed March 23, 2010.
- Abbott receives U.S. FDA approval for heat-stable Norvir (ritonavir) tablets. Abbott website. Available at: http://www.abbott.com/global/url/pressRelease/en_US/60.5:5/Press_Release_0820.htm. Accessed March 23, 2010.
- Novo Nordisk receives FDA approval for Norditropin FlexPro for growth hormone treatment. Novo Nordisk website. Available at: http://press.novonordisk-us.com/index.php?s=43&item=239. Accessed March 23, 2010.
- Dane L. Shire receives FDA fast-track designation for Replagal. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=97AF48EBA7054EF0857F055877E82B2C&logRowId=352323. Accessed March 23, 2010.
- Amylin shares up on FDA response for diabetes drug. Forbes website. Available at: http://www.forbes.com/feeds/ap/2010/03/15/business-health-care-us-amylin-mover_7435579.html. Accessed March 23, 2010.
- Russell J. MannKind drug fails to win FDA approval. Los Angeles Business Journal website. Available at: http://labusinessjournal.com/article.asp?aid=4998235.0597195.1894204.8500584.7421642.713. Accessed March 23, 2010.
- U.S. Food and Drug Administration accepts NDA for once-daily fixed dose combination of Onglyza (saxagliptin) and extended-release metformin for the treatment of type 2 diabetes mellitus in adults. AstraZeneca website. Available at: http://www.astrazeneca-us.com/about-astrazeneca-us/newsroom/product/8804120?itemId=8804120#. Accessed March 23, 2010.
- Dennis M. GlaxoSmithKline begins late-stage clinical programme for asthma drug Relovair. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=E256469FBD8F4A2F80C5DD3E844CC1E1&logRowId=356423. Accessed March 23, 2010.