In early December 2013, the FDA will formally recommend to the US Department of Health and Human Services (HHS) that hydrocodone combination products be reclassified as Schedule II drugs. The proposed change would tighten the controls on these products, which now are classified as Schedule III. The recommendation follows the US Drug Enforcement Administration’s (DEA) 2009 request for guidance from HHS regarding hydrocodone combination products such as Vicodin. The FDA’s determination is the result of an analysis of the scientific literature, a review of hundreds of public comments on the issue, and several public meetings, according to a statement by Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research. The recommendation will influence the DEA’s final decision on the appropriate scheduling of these products.

Influenza vaccination may reduce patients’ risk of major adverse cardiovascular events, including stroke, according to a meta-analysis published October 23 in JAMA. Researchers conducted a systematic review of randomized clinical trials listed in MEDLINE, EMBASE, and the Cochrane Library Central Register of Controlled Trials that compared influenza vaccine with placebo or control in patients at high risk of cardiovascular disease. Six trials encompassing 6,735 patients were included. Influenza vaccine was associated with a lower risk of composite cardiovascular events (2.9% vs 4.7%) in published trials. A treatment interaction was detected between patients with and without recent acute coronary syndrome. The greatest treatment effect was observed among the highest-risk patients with more active coronary disease, and a larger trial is warranted to assess these findings, said the researchers.

Short sleep duration and poor sleep quality may be associated with greater β-amyloid burden among community-dwelling older adults, according to research published online ahead of print October 21 in JAMA Neurology. Investigators performed a cross-sectional study of 70 adult participants (mean age, 76) in the neuroimaging substudy of the Baltimore Longitudinal Study of Aging. The study’s main outcome measure was β-amyloid burden, measured by carbon 11-labeled Pittsburgh compound B PET distribution volume ratios. After adjustment for potential confounders, the researchers found an association between reports of shorter sleep duration and greater β-amyloid burden, measured by mean cortical distribution volume ratio and precuneus distribution volume ratio. Reports of lower sleep quality were associated with greater β-amyloid burden, measured by precuneus distribution volume ratio.

High blood glucose levels may adversely affect cognition, even among patients without type 2 diabetes or impaired glucose tolerance, researchers reported online ahead of print October 23 in Neurology. The effect may be mediated by structural changes in learning-relevant brain areas, the authors noted. The group tested memory in 141 individuals using the Rey Auditory Verbal Learning Test and acquired peripheral levels of fasting HbA1c, glucose, and insulin. Clinicians performed 3-T MRI scans to assess hippocampal volume and microstructure. Lower HbA1c and glucose levels were significantly associated with better scores in delayed recall, learning ability, and memory consolidation. In multiple regression models, HbA1c remained strongly associated with memory performance. Mediation analyses indicated that beneficial effects of lower HbA1c on memory are partly mediated by hippocampal volume and microstructure.

Among older adults, arterial stiffness may be associated with b-amyloid plaque deposition in the brain, independent of blood pressure and APOE ε4 allele, according to a study published online ahead of print October 16 in Neurology. Investigators studied 91 dementia-free participants between ages 83 and 96. Participants underwent brain MRI and PET imaging with Pittsburgh compound B. The researchers measured resting blood pressure (BP), mean arterial pressure (MAP), and arterial stiffness by pulse wave velocity (PWV) in the central, peripheral, and mixed vascular beds. A total of 44 subjects were β-amyloid positive on PET scan. The investigators found that β-amyloid deposition was associated with mixed PWV, systolic BP, and MAP. One SD increase in brachial ankle PWV resulted in a twofold increase in the odds of being β-amyloid positive.

The FDA has approved Vizamyl (flutemetamol F 18 injection), a radioactive diagnostic drug, for use with PET imaging of the brain in adults being evaluated for Alzheimer’s disease and dementia. Vizamyl attaches to β-amyloid and produces a PET image that is used to evaluate the presence of β-amyloid. The drug’s effectiveness was established in two clinical studies of 384 participants with a range of cognitive function. All participants were injected with Vizamyl and scanned. The images were interpreted by five independent readers masked to all clinical information. A portion of scan results was also confirmed by autopsy. Following the approval of Amyvid (Florbetapir F 18 injection) in 2012, Vizamyl, manufactured by Medi-Physics (Arlington Heights, Illinois), becomes the second diagnostic drug available for visualizing β-amyloid on a PET scan of the brain.

Clostridium perfringens type B, an epsilon toxin-secreting bacillus, may trigger multiple sclerosis (MS), according to research published October 16 in PLOS One. After detecting C. perfringens type B in a woman with MS, investigators tested blood and CSF from patients with MS and controls for antibody reactivity to the epsilon toxin. Levels of epsilon toxin antibodies were 10 times higher in patients with MS, compared with controls. After examining stool samples, the study authors found the human commensal C. perfringens type A in approximately 50% of healthy controls, compared with 23% of patients with MS. C. perfringens epsilon toxin fits mechanistically with nascent MS lesion formation because these lesions are characterized by blood–brain barrier permeability and oligodendrocyte cell death in the absence of an adaptive immune infiltrate, said the researchers.

Chronic cerebrospinal venous insufficiency (CCSVI), which has been proposed as a contributor to multiple sclerosis (MS), occurs rarely in patients with MS and in controls, according to a study published online ahead of print October 8 in Lancet. Researchers performed an assessor-blinded, case-control, multicenter study of 79 people with MS, 55 unaffected siblings, and 43 unrelated healthy volunteers. Catheter venography criteria for CCSVI were positive for 2% of people with MS, 2% of siblings, and 3% of unrelated controls. Greater than 50% narrowing of any major vein was present in 74% of people with MS, 66% of siblings, and 70% of unrelated controls. The Zamboni ultrasound criteria are neither sensitive nor specific for narrowing on catheter venography, and the significance of venous narrowing to MS remains unknown, said the investigators.

Measures of α-synuclein deposition in cutaneous autonomic nerves may be a useful biomarker in patients with Parkinson’s disease, according to research published online ahead of print October 2 in Neurology. Investigators examined 20 patients with Parkinson’s disease and 14 age- and sex-matched control subjects. The researchers performed autonomic testing and skin biopsies at the distal leg, distal thigh, and proximal thigh for all participants. Deposition of α-synuclein and the density of intraepidermal, sudomotor, and pilomotor nerve fibers were measured. The investigators normalized α-synuclein deposition to nerve fiber density. Patients with Parkinson’s disease had greater α-synuclein deposition and higher α-synuclein ratios than controls within pilomotor nerves and sudomotor nerves, but not sensory nerves. Higher α-synuclein ratios correlated with Hoehn and Yahr scores, sympathetic adrenergic function, and parasympathetic function.

Depression may be an independent risk factor for Parkinson’s disease, according to research published October 22 in Neurology. Investigators conducted a retrospective study of 4,634 patients with depression and 18,544 matched controls who were selected from a national health insurance database. Patients were observed for a maximum of 10 years to determine the rates of new-onset Parkinson’s disease. Cox regression was used to identify the predictors of the disease. During the follow-up period, 66 patients with depression and 97 controls were diagnosed with Parkinson’s disease. After adjusting for age and sex, the researchers found that patients with depression were 3.24 times more likely to develop Parkinson’s disease, compared with the control patients. The investigators observed that age and difficult-to-treat depression are independent risk factors for Parkinson’s disease in patients with depression.

The levels of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) in red blood cells may have no association with age-associated cognitive decline, researchers reported in the October 22 issue of Neurology. The investigators conducted a retrospective cohort study of 2,157 women with normal cognition who were followed with annual cognitive testing for a median of 5.9 years. End points were composite cognitive function and performance in seven cognitive domains. After adjustment for demographic, clinical, and behavioral characteristics, the investigators found no significant cross-sectional cognitive differences between women in the high and low DHA and EPA tertiles at the first annual cognitive battery. In addition, no significant differences were found between the high and low DHA and EPA tertiles in the rate of cognitive change over time.

Common psychosocial stressors (eg, divorce, widowhood, work problems, and illness in a relative) may have severe and long-standing physiologic and psychologic consequences such as dementia, according to research published September 30 in BMJ Open. In a prospective longitudinal population study, clinicians performed psychiatric examinations for 800 women born in 1914, 1918, 1922, and 1930. Baseline examinations took place in 1968, and follow-up occurred in 1974, 1980, 1992, 2000, and 2005. During follow-up, 153 women developed dementia. The number of psychosocial stressors in 1968 was associated with higher incidence of dementia and Alzheimer’s disease (AD) between 1968 and 2005 in multivariate Cox regressions. The number of psychosocial stressors in 1968 was also associated with distress in 1968, 1974, 1980, 2000, and 2005 in multivariate logistic regressions.

Aggressive medical management may provide more benefit than percutaneous transluminal angioplasty and stenting (PTAS) for high-risk patients with atherosclerotic intracranial arterial stenosis, according to a study published online ahead of print October 26 in Lancet. Investigators randomized 451 patients with recent transient ischemic attack or stroke to aggressive medical management or aggressive medical management plus stenting with the Wingspan stent. The cumulative probability of stroke or death was smaller in the medical group vs the PTAS group. Beyond 30 days, 10% of patients in the medical group and 10% of patients in the stenting group had a primary end point. The absolute differences in the primary end point rates between the two groups were 7.1% at year 1, 6.5% at year 2 and 9.0% at year 3.

—Erik Greb
Senior Associate Editor

In early December 2013, the FDA will formally recommend to the US Department of Health and Human Services (HHS) that hydrocodone combination products be reclassified as Schedule II drugs. The proposed change would tighten the controls on these products, which now are classified as Schedule III. The recommendation follows the US Drug Enforcement Administration’s (DEA) 2009 request for guidance from HHS regarding hydrocodone combination products such as Vicodin. The FDA’s determination is the result of an analysis of the scientific literature, a review of hundreds of public comments on the issue, and several public meetings, according to a statement by Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research. The recommendation will influence the DEA’s final decision on the appropriate scheduling of these products.

Influenza vaccination may reduce patients’ risk of major adverse cardiovascular events, including stroke, according to a meta-analysis published October 23 in JAMA. Researchers conducted a systematic review of randomized clinical trials listed in MEDLINE, EMBASE, and the Cochrane Library Central Register of Controlled Trials that compared influenza vaccine with placebo or control in patients at high risk of cardiovascular disease. Six trials encompassing 6,735 patients were included. Influenza vaccine was associated with a lower risk of composite cardiovascular events (2.9% vs 4.7%) in published trials. A treatment interaction was detected between patients with and without recent acute coronary syndrome. The greatest treatment effect was observed among the highest-risk patients with more active coronary disease, and a larger trial is warranted to assess these findings, said the researchers.

Short sleep duration and poor sleep quality may be associated with greater β-amyloid burden among community-dwelling older adults, according to research published online ahead of print October 21 in JAMA Neurology. Investigators performed a cross-sectional study of 70 adult participants (mean age, 76) in the neuroimaging substudy of the Baltimore Longitudinal Study of Aging. The study’s main outcome measure was β-amyloid burden, measured by carbon 11-labeled Pittsburgh compound B PET distribution volume ratios. After adjustment for potential confounders, the researchers found an association between reports of shorter sleep duration and greater β-amyloid burden, measured by mean cortical distribution volume ratio and precuneus distribution volume ratio. Reports of lower sleep quality were associated with greater β-amyloid burden, measured by precuneus distribution volume ratio.

High blood glucose levels may adversely affect cognition, even among patients without type 2 diabetes or impaired glucose tolerance, researchers reported online ahead of print October 23 in Neurology. The effect may be mediated by structural changes in learning-relevant brain areas, the authors noted. The group tested memory in 141 individuals using the Rey Auditory Verbal Learning Test and acquired peripheral levels of fasting HbA1c, glucose, and insulin. Clinicians performed 3-T MRI scans to assess hippocampal volume and microstructure. Lower HbA1c and glucose levels were significantly associated with better scores in delayed recall, learning ability, and memory consolidation. In multiple regression models, HbA1c remained strongly associated with memory performance. Mediation analyses indicated that beneficial effects of lower HbA1c on memory are partly mediated by hippocampal volume and microstructure.

Among older adults, arterial stiffness may be associated with b-amyloid plaque deposition in the brain, independent of blood pressure and APOE ε4 allele, according to a study published online ahead of print October 16 in Neurology. Investigators studied 91 dementia-free participants between ages 83 and 96. Participants underwent brain MRI and PET imaging with Pittsburgh compound B. The researchers measured resting blood pressure (BP), mean arterial pressure (MAP), and arterial stiffness by pulse wave velocity (PWV) in the central, peripheral, and mixed vascular beds. A total of 44 subjects were β-amyloid positive on PET scan. The investigators found that β-amyloid deposition was associated with mixed PWV, systolic BP, and MAP. One SD increase in brachial ankle PWV resulted in a twofold increase in the odds of being β-amyloid positive.

The FDA has approved Vizamyl (flutemetamol F 18 injection), a radioactive diagnostic drug, for use with PET imaging of the brain in adults being evaluated for Alzheimer’s disease and dementia. Vizamyl attaches to β-amyloid and produces a PET image that is used to evaluate the presence of β-amyloid. The drug’s effectiveness was established in two clinical studies of 384 participants with a range of cognitive function. All participants were injected with Vizamyl and scanned. The images were interpreted by five independent readers masked to all clinical information. A portion of scan results was also confirmed by autopsy. Following the approval of Amyvid (Florbetapir F 18 injection) in 2012, Vizamyl, manufactured by Medi-Physics (Arlington Heights, Illinois), becomes the second diagnostic drug available for visualizing β-amyloid on a PET scan of the brain.

Clostridium perfringens type B, an epsilon toxin-secreting bacillus, may trigger multiple sclerosis (MS), according to research published October 16 in PLOS One. After detecting C. perfringens type B in a woman with MS, investigators tested blood and CSF from patients with MS and controls for antibody reactivity to the epsilon toxin. Levels of epsilon toxin antibodies were 10 times higher in patients with MS, compared with controls. After examining stool samples, the study authors found the human commensal C. perfringens type A in approximately 50% of healthy controls, compared with 23% of patients with MS. C. perfringens epsilon toxin fits mechanistically with nascent MS lesion formation because these lesions are characterized by blood–brain barrier permeability and oligodendrocyte cell death in the absence of an adaptive immune infiltrate, said the researchers.

Chronic cerebrospinal venous insufficiency (CCSVI), which has been proposed as a contributor to multiple sclerosis (MS), occurs rarely in patients with MS and in controls, according to a study published online ahead of print October 8 in Lancet. Researchers performed an assessor-blinded, case-control, multicenter study of 79 people with MS, 55 unaffected siblings, and 43 unrelated healthy volunteers. Catheter venography criteria for CCSVI were positive for 2% of people with MS, 2% of siblings, and 3% of unrelated controls. Greater than 50% narrowing of any major vein was present in 74% of people with MS, 66% of siblings, and 70% of unrelated controls. The Zamboni ultrasound criteria are neither sensitive nor specific for narrowing on catheter venography, and the significance of venous narrowing to MS remains unknown, said the investigators.

Measures of α-synuclein deposition in cutaneous autonomic nerves may be a useful biomarker in patients with Parkinson’s disease, according to research published online ahead of print October 2 in Neurology. Investigators examined 20 patients with Parkinson’s disease and 14 age- and sex-matched control subjects. The researchers performed autonomic testing and skin biopsies at the distal leg, distal thigh, and proximal thigh for all participants. Deposition of α-synuclein and the density of intraepidermal, sudomotor, and pilomotor nerve fibers were measured. The investigators normalized α-synuclein deposition to nerve fiber density. Patients with Parkinson’s disease had greater α-synuclein deposition and higher α-synuclein ratios than controls within pilomotor nerves and sudomotor nerves, but not sensory nerves. Higher α-synuclein ratios correlated with Hoehn and Yahr scores, sympathetic adrenergic function, and parasympathetic function.

Depression may be an independent risk factor for Parkinson’s disease, according to research published October 22 in Neurology. Investigators conducted a retrospective study of 4,634 patients with depression and 18,544 matched controls who were selected from a national health insurance database. Patients were observed for a maximum of 10 years to determine the rates of new-onset Parkinson’s disease. Cox regression was used to identify the predictors of the disease. During the follow-up period, 66 patients with depression and 97 controls were diagnosed with Parkinson’s disease. After adjusting for age and sex, the researchers found that patients with depression were 3.24 times more likely to develop Parkinson’s disease, compared with the control patients. The investigators observed that age and difficult-to-treat depression are independent risk factors for Parkinson’s disease in patients with depression.

The levels of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) in red blood cells may have no association with age-associated cognitive decline, researchers reported in the October 22 issue of Neurology. The investigators conducted a retrospective cohort study of 2,157 women with normal cognition who were followed with annual cognitive testing for a median of 5.9 years. End points were composite cognitive function and performance in seven cognitive domains. After adjustment for demographic, clinical, and behavioral characteristics, the investigators found no significant cross-sectional cognitive differences between women in the high and low DHA and EPA tertiles at the first annual cognitive battery. In addition, no significant differences were found between the high and low DHA and EPA tertiles in the rate of cognitive change over time.

Common psychosocial stressors (eg, divorce, widowhood, work problems, and illness in a relative) may have severe and long-standing physiologic and psychologic consequences such as dementia, according to research published September 30 in BMJ Open. In a prospective longitudinal population study, clinicians performed psychiatric examinations for 800 women born in 1914, 1918, 1922, and 1930. Baseline examinations took place in 1968, and follow-up occurred in 1974, 1980, 1992, 2000, and 2005. During follow-up, 153 women developed dementia. The number of psychosocial stressors in 1968 was associated with higher incidence of dementia and Alzheimer’s disease (AD) between 1968 and 2005 in multivariate Cox regressions. The number of psychosocial stressors in 1968 was also associated with distress in 1968, 1974, 1980, 2000, and 2005 in multivariate logistic regressions.

Aggressive medical management may provide more benefit than percutaneous transluminal angioplasty and stenting (PTAS) for high-risk patients with atherosclerotic intracranial arterial stenosis, according to a study published online ahead of print October 26 in Lancet. Investigators randomized 451 patients with recent transient ischemic attack or stroke to aggressive medical management or aggressive medical management plus stenting with the Wingspan stent. The cumulative probability of stroke or death was smaller in the medical group vs the PTAS group. Beyond 30 days, 10% of patients in the medical group and 10% of patients in the stenting group had a primary end point. The absolute differences in the primary end point rates between the two groups were 7.1% at year 1, 6.5% at year 2 and 9.0% at year 3.

—Erik Greb
Senior Associate Editor

In early December 2013, the FDA will formally recommend to the US Department of Health and Human Services (HHS) that hydrocodone combination products be reclassified as Schedule II drugs. The proposed change would tighten the controls on these products, which now are classified as Schedule III. The recommendation follows the US Drug Enforcement Administration’s (DEA) 2009 request for guidance from HHS regarding hydrocodone combination products such as Vicodin. The FDA’s determination is the result of an analysis of the scientific literature, a review of hundreds of public comments on the issue, and several public meetings, according to a statement by Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research. The recommendation will influence the DEA’s final decision on the appropriate scheduling of these products.

Influenza vaccination may reduce patients’ risk of major adverse cardiovascular events, including stroke, according to a meta-analysis published October 23 in JAMA. Researchers conducted a systematic review of randomized clinical trials listed in MEDLINE, EMBASE, and the Cochrane Library Central Register of Controlled Trials that compared influenza vaccine with placebo or control in patients at high risk of cardiovascular disease. Six trials encompassing 6,735 patients were included. Influenza vaccine was associated with a lower risk of composite cardiovascular events (2.9% vs 4.7%) in published trials. A treatment interaction was detected between patients with and without recent acute coronary syndrome. The greatest treatment effect was observed among the highest-risk patients with more active coronary disease, and a larger trial is warranted to assess these findings, said the researchers.

Short sleep duration and poor sleep quality may be associated with greater β-amyloid burden among community-dwelling older adults, according to research published online ahead of print October 21 in JAMA Neurology. Investigators performed a cross-sectional study of 70 adult participants (mean age, 76) in the neuroimaging substudy of the Baltimore Longitudinal Study of Aging. The study’s main outcome measure was β-amyloid burden, measured by carbon 11-labeled Pittsburgh compound B PET distribution volume ratios. After adjustment for potential confounders, the researchers found an association between reports of shorter sleep duration and greater β-amyloid burden, measured by mean cortical distribution volume ratio and precuneus distribution volume ratio. Reports of lower sleep quality were associated with greater β-amyloid burden, measured by precuneus distribution volume ratio.

High blood glucose levels may adversely affect cognition, even among patients without type 2 diabetes or impaired glucose tolerance, researchers reported online ahead of print October 23 in Neurology. The effect may be mediated by structural changes in learning-relevant brain areas, the authors noted. The group tested memory in 141 individuals using the Rey Auditory Verbal Learning Test and acquired peripheral levels of fasting HbA1c, glucose, and insulin. Clinicians performed 3-T MRI scans to assess hippocampal volume and microstructure. Lower HbA1c and glucose levels were significantly associated with better scores in delayed recall, learning ability, and memory consolidation. In multiple regression models, HbA1c remained strongly associated with memory performance. Mediation analyses indicated that beneficial effects of lower HbA1c on memory are partly mediated by hippocampal volume and microstructure.

Among older adults, arterial stiffness may be associated with b-amyloid plaque deposition in the brain, independent of blood pressure and APOE ε4 allele, according to a study published online ahead of print October 16 in Neurology. Investigators studied 91 dementia-free participants between ages 83 and 96. Participants underwent brain MRI and PET imaging with Pittsburgh compound B. The researchers measured resting blood pressure (BP), mean arterial pressure (MAP), and arterial stiffness by pulse wave velocity (PWV) in the central, peripheral, and mixed vascular beds. A total of 44 subjects were β-amyloid positive on PET scan. The investigators found that β-amyloid deposition was associated with mixed PWV, systolic BP, and MAP. One SD increase in brachial ankle PWV resulted in a twofold increase in the odds of being β-amyloid positive.

The FDA has approved Vizamyl (flutemetamol F 18 injection), a radioactive diagnostic drug, for use with PET imaging of the brain in adults being evaluated for Alzheimer’s disease and dementia. Vizamyl attaches to β-amyloid and produces a PET image that is used to evaluate the presence of β-amyloid. The drug’s effectiveness was established in two clinical studies of 384 participants with a range of cognitive function. All participants were injected with Vizamyl and scanned. The images were interpreted by five independent readers masked to all clinical information. A portion of scan results was also confirmed by autopsy. Following the approval of Amyvid (Florbetapir F 18 injection) in 2012, Vizamyl, manufactured by Medi-Physics (Arlington Heights, Illinois), becomes the second diagnostic drug available for visualizing β-amyloid on a PET scan of the brain.

Clostridium perfringens type B, an epsilon toxin-secreting bacillus, may trigger multiple sclerosis (MS), according to research published October 16 in PLOS One. After detecting C. perfringens type B in a woman with MS, investigators tested blood and CSF from patients with MS and controls for antibody reactivity to the epsilon toxin. Levels of epsilon toxin antibodies were 10 times higher in patients with MS, compared with controls. After examining stool samples, the study authors found the human commensal C. perfringens type A in approximately 50% of healthy controls, compared with 23% of patients with MS. C. perfringens epsilon toxin fits mechanistically with nascent MS lesion formation because these lesions are characterized by blood–brain barrier permeability and oligodendrocyte cell death in the absence of an adaptive immune infiltrate, said the researchers.

Chronic cerebrospinal venous insufficiency (CCSVI), which has been proposed as a contributor to multiple sclerosis (MS), occurs rarely in patients with MS and in controls, according to a study published online ahead of print October 8 in Lancet. Researchers performed an assessor-blinded, case-control, multicenter study of 79 people with MS, 55 unaffected siblings, and 43 unrelated healthy volunteers. Catheter venography criteria for CCSVI were positive for 2% of people with MS, 2% of siblings, and 3% of unrelated controls. Greater than 50% narrowing of any major vein was present in 74% of people with MS, 66% of siblings, and 70% of unrelated controls. The Zamboni ultrasound criteria are neither sensitive nor specific for narrowing on catheter venography, and the significance of venous narrowing to MS remains unknown, said the investigators.

Measures of α-synuclein deposition in cutaneous autonomic nerves may be a useful biomarker in patients with Parkinson’s disease, according to research published online ahead of print October 2 in Neurology. Investigators examined 20 patients with Parkinson’s disease and 14 age- and sex-matched control subjects. The researchers performed autonomic testing and skin biopsies at the distal leg, distal thigh, and proximal thigh for all participants. Deposition of α-synuclein and the density of intraepidermal, sudomotor, and pilomotor nerve fibers were measured. The investigators normalized α-synuclein deposition to nerve fiber density. Patients with Parkinson’s disease had greater α-synuclein deposition and higher α-synuclein ratios than controls within pilomotor nerves and sudomotor nerves, but not sensory nerves. Higher α-synuclein ratios correlated with Hoehn and Yahr scores, sympathetic adrenergic function, and parasympathetic function.

Depression may be an independent risk factor for Parkinson’s disease, according to research published October 22 in Neurology. Investigators conducted a retrospective study of 4,634 patients with depression and 18,544 matched controls who were selected from a national health insurance database. Patients were observed for a maximum of 10 years to determine the rates of new-onset Parkinson’s disease. Cox regression was used to identify the predictors of the disease. During the follow-up period, 66 patients with depression and 97 controls were diagnosed with Parkinson’s disease. After adjusting for age and sex, the researchers found that patients with depression were 3.24 times more likely to develop Parkinson’s disease, compared with the control patients. The investigators observed that age and difficult-to-treat depression are independent risk factors for Parkinson’s disease in patients with depression.

The levels of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) in red blood cells may have no association with age-associated cognitive decline, researchers reported in the October 22 issue of Neurology. The investigators conducted a retrospective cohort study of 2,157 women with normal cognition who were followed with annual cognitive testing for a median of 5.9 years. End points were composite cognitive function and performance in seven cognitive domains. After adjustment for demographic, clinical, and behavioral characteristics, the investigators found no significant cross-sectional cognitive differences between women in the high and low DHA and EPA tertiles at the first annual cognitive battery. In addition, no significant differences were found between the high and low DHA and EPA tertiles in the rate of cognitive change over time.

Common psychosocial stressors (eg, divorce, widowhood, work problems, and illness in a relative) may have severe and long-standing physiologic and psychologic consequences such as dementia, according to research published September 30 in BMJ Open. In a prospective longitudinal population study, clinicians performed psychiatric examinations for 800 women born in 1914, 1918, 1922, and 1930. Baseline examinations took place in 1968, and follow-up occurred in 1974, 1980, 1992, 2000, and 2005. During follow-up, 153 women developed dementia. The number of psychosocial stressors in 1968 was associated with higher incidence of dementia and Alzheimer’s disease (AD) between 1968 and 2005 in multivariate Cox regressions. The number of psychosocial stressors in 1968 was also associated with distress in 1968, 1974, 1980, 2000, and 2005 in multivariate logistic regressions.

Aggressive medical management may provide more benefit than percutaneous transluminal angioplasty and stenting (PTAS) for high-risk patients with atherosclerotic intracranial arterial stenosis, according to a study published online ahead of print October 26 in Lancet. Investigators randomized 451 patients with recent transient ischemic attack or stroke to aggressive medical management or aggressive medical management plus stenting with the Wingspan stent. The cumulative probability of stroke or death was smaller in the medical group vs the PTAS group. Beyond 30 days, 10% of patients in the medical group and 10% of patients in the stenting group had a primary end point. The absolute differences in the primary end point rates between the two groups were 7.1% at year 1, 6.5% at year 2 and 9.0% at year 3.

—Erik Greb
Senior Associate Editor

Topics

• Anticipated Time Horizon For VAD Support
• Incorporating VAD Implantation Earlier In Heart Failure Progression
• Support Structure For VAD Program Success

Faculty/Faculty Disclosures

John B. O’Connell, MD
Thoratec Corporation
Pleasanton, CA

Dr O’Connell discloses that at the time of the roundtable discussion he was a paid consultant for Thoratec Corporation. As of September 30, 2013, he is a full-time employee of Thoratec Corporation. Dr O’Connell also discloses that he is on the Data and Safety Monitoring Committee for Auven Therapeutics.

Walter Dembitsky, MD
Sharp Memorial Hospital
San Diego, CA

Dr Dembitsky discloses that he is a paid consultant and lecturer for, and has received research grants from, Thoratec Corporation.

Ranjit John, MD
University of Minnesota
Minneapolis, MI

Dr John discloses that he is a paid consultant for, and has received research grants from, Thoratec Corporation.

Jaap Lahpor, MD, PhD
University Medical Centre Utrecht
Utrecht, Netherlands

Dr Lahpor discloses that he is a paid consultant and speaker for Thoratec Corporation.

Jonathan D. Rich, MD
Northwestern University
Chicago, IL

Dr Rich discloses that he has received honoraria in the past from Thoratec Corporation.

Welcome to Audiocast #1 of 3. In this audiocast we will discuss the question: When you evaluate a patient for VAD therapy, what time horizon for support do you have in mind?

Welcome to Audiocast #2 of 3. In this audiocast we will answer the question: As patients are supported for longer periods of time, is trying to implant patients earlier in their heart failure progression becoming more important?

Welcome to Audiocast #3 of 3. In this audiocast we will ask the question: As more and more patients are supported for longer periods of time, what types of additional support structure will be required and how are we measuring success?

Topics

• Anticipated Time Horizon For VAD Support
• Incorporating VAD Implantation Earlier In Heart Failure Progression
• Support Structure For VAD Program Success

Faculty/Faculty Disclosures

John B. O’Connell, MD
Thoratec Corporation
Pleasanton, CA

Dr O’Connell discloses that at the time of the roundtable discussion he was a paid consultant for Thoratec Corporation. As of September 30, 2013, he is a full-time employee of Thoratec Corporation. Dr O’Connell also discloses that he is on the Data and Safety Monitoring Committee for Auven Therapeutics.

Walter Dembitsky, MD
Sharp Memorial Hospital
San Diego, CA

Dr Dembitsky discloses that he is a paid consultant and lecturer for, and has received research grants from, Thoratec Corporation.

Ranjit John, MD
University of Minnesota
Minneapolis, MI

Dr John discloses that he is a paid consultant for, and has received research grants from, Thoratec Corporation.

Jaap Lahpor, MD, PhD
University Medical Centre Utrecht
Utrecht, Netherlands

Dr Lahpor discloses that he is a paid consultant and speaker for Thoratec Corporation.

Jonathan D. Rich, MD
Northwestern University
Chicago, IL

Dr Rich discloses that he has received honoraria in the past from Thoratec Corporation.

Welcome to Audiocast #1 of 3. In this audiocast we will discuss the question: When you evaluate a patient for VAD therapy, what time horizon for support do you have in mind?

Welcome to Audiocast #2 of 3. In this audiocast we will answer the question: As patients are supported for longer periods of time, is trying to implant patients earlier in their heart failure progression becoming more important?

Welcome to Audiocast #3 of 3. In this audiocast we will ask the question: As more and more patients are supported for longer periods of time, what types of additional support structure will be required and how are we measuring success?

Topics

• Anticipated Time Horizon For VAD Support
• Incorporating VAD Implantation Earlier In Heart Failure Progression
• Support Structure For VAD Program Success

Faculty/Faculty Disclosures

John B. O’Connell, MD
Thoratec Corporation
Pleasanton, CA

Dr O’Connell discloses that at the time of the roundtable discussion he was a paid consultant for Thoratec Corporation. As of September 30, 2013, he is a full-time employee of Thoratec Corporation. Dr O’Connell also discloses that he is on the Data and Safety Monitoring Committee for Auven Therapeutics.

Walter Dembitsky, MD
Sharp Memorial Hospital
San Diego, CA

Dr Dembitsky discloses that he is a paid consultant and lecturer for, and has received research grants from, Thoratec Corporation.

Ranjit John, MD
University of Minnesota
Minneapolis, MI

Dr John discloses that he is a paid consultant for, and has received research grants from, Thoratec Corporation.

Jaap Lahpor, MD, PhD
University Medical Centre Utrecht
Utrecht, Netherlands

Dr Lahpor discloses that he is a paid consultant and speaker for Thoratec Corporation.

Jonathan D. Rich, MD
Northwestern University
Chicago, IL

Dr Rich discloses that he has received honoraria in the past from Thoratec Corporation.

Welcome to Audiocast #1 of 3. In this audiocast we will discuss the question: When you evaluate a patient for VAD therapy, what time horizon for support do you have in mind?

Welcome to Audiocast #2 of 3. In this audiocast we will answer the question: As patients are supported for longer periods of time, is trying to implant patients earlier in their heart failure progression becoming more important?

Welcome to Audiocast #3 of 3. In this audiocast we will ask the question: As more and more patients are supported for longer periods of time, what types of additional support structure will be required and how are we measuring success?

We were called to the emergency department to see a young woman, DR, with metastatic endometrial cancer. She had presented with abdominal pain and was found to have evidence of perforation on CT imaging. The CT also demonstrated the unresectable uterus and multiple peritoneal implants. The tumor had not been responsive to the last bout of chemotherapy. DR had been less active, and had lost significant weight over the last several months. A former real estate agent, she hadn’t worked since her diagnosis. She lived with a friend and had a daughter who was very worried about her condition.

I was also worried. After looking at the CT I had told the resident over the phone that operation might not be a great choice. Yes but the family "wants everything done," she replied... CRINGE. "I’ll be over," I said.

Why do we cringe at this statement? Perhaps we feel trapped by a family (or a medical team) who suggests we do everything. There is no out. The die has been cast. This is certainly the case when a non-surgical team has suggested to a family the option of a last-ditch operative intervention. What scares us about the family who wants "everything done"? Often, we don’t think we should be intervening with a surgical operation when the outcome appears dismal. We are concerned with litigation if we don’t try "everything." We fear the communication challenge of speaking with a family with "unrealistic expectations."

But if we take a step back, we might gain some appreciation for the family perspective. Who wouldn’t want everything done to save a loved one, or to prolong our time with a loved one? Who wouldn’t want everything done that might maximize the opportunity for recovery? And who would ever want to do nothing for a loved one in a medical crisis?

I have witnessed (and participated in) two responses to these challenging moments. The first is to acquiesce and perform an operation as a "last-ditch effort." The second is to simply refuse to intervene or even refuse the consult. Neither of these approaches is serves the patient, his or her family, or the health care team (including ourselves). To simply acquiesce puts the patient at increased risk of suffering, gives the family a false notion of hope, and creates moral distress in our team. To simply refuse and walk away leads to patient and family abandonment (with a lack of understanding why operative intervention is not indicated) and leads to conflict within our health care team.

I suggest we enter these situations with the premise that we always do everything and we never do nothing. We do our best to provide treatments to meet the goals and needs of our patients and their loved ones. At times, this may mean a surgical intervention to restore a patient to full premorbid health. At others, this may mean an operation to alleviate suffering, for example, from a malignant bowel obstruction. And sometimes this means not operating as it will only increase or prolong suffering. Yet in the latter situation, there are plenty of appropriate interventions: relieving pain or dyspnea, providing spiritual support, promoting bereavement, and assisting all participants in avoiding complicated grief. These therapies can and should be provided with the same aggressive approach with which we provide operative therapy.

With this approach we are able to reassure our patients and their loved ones that our interests lie in providing the best possible treatments in meeting their goals and needs. And that no matter what, we will find a means to help in some way.

As we sat in the emergency department, we reassured DR that we were there to help and find the best course of action. We admitted our uncertainty with the immediate prognosis with or without operative intervention, but that ultimately she was dying from the cancer. She expressed that she was not ready to die. "I hope we can avoid death as long as possible," I said. "While I am unsure which course of action will prolong your life the most, I am concerned that with operation your death has a higher likelihood of occurring in the midst of a prolonged ICU stay. If we try antibiotic therapy and pain control you might have more of an opportunity to spend time with your daughter and friends." We recommended avoiding operation, focusing on symptom management, and maximizing time with her loved ones.

DR wanted time. She was admitted for antibiotic therapy and aggressive symptom control with a consult to palliative medicine. She stabilized and was able to be transitioned to home hospice with her daughter and friend as caretakers.

This approach is effectively one of risk and benefit, recognition of uncertainty, and adherence to patient values. We recognize the inevitability of death from the beginning of a serious illness and openly discuss with our patients their fears and goals. We join with them in the uncertain future and the hard decisions to come. We work with patients to embrace life-enhancing therapies and to forgo death-avoiding therapies in order to maximize those that work toward patient-centered outcomes. This is a world in which we aggressively do everything to promote health, broadly defined, and ameliorate suffering. We always do everything.

Dr. Weinstein is an ACS Fellow and associate professor of surgery at Thomas Jefferson University in Philadelphia. He is director of the surgical intensive care unit and Executive Medical Co-Director of the Thomas Jefferson University Hospital Center for Critical Care. He is a member of the Palliative Care Task Force of the American College of Surgeons.

We were called to the emergency department to see a young woman, DR, with metastatic endometrial cancer. She had presented with abdominal pain and was found to have evidence of perforation on CT imaging. The CT also demonstrated the unresectable uterus and multiple peritoneal implants. The tumor had not been responsive to the last bout of chemotherapy. DR had been less active, and had lost significant weight over the last several months. A former real estate agent, she hadn’t worked since her diagnosis. She lived with a friend and had a daughter who was very worried about her condition.

I was also worried. After looking at the CT I had told the resident over the phone that operation might not be a great choice. Yes but the family "wants everything done," she replied... CRINGE. "I’ll be over," I said.

Why do we cringe at this statement? Perhaps we feel trapped by a family (or a medical team) who suggests we do everything. There is no out. The die has been cast. This is certainly the case when a non-surgical team has suggested to a family the option of a last-ditch operative intervention. What scares us about the family who wants "everything done"? Often, we don’t think we should be intervening with a surgical operation when the outcome appears dismal. We are concerned with litigation if we don’t try "everything." We fear the communication challenge of speaking with a family with "unrealistic expectations."

But if we take a step back, we might gain some appreciation for the family perspective. Who wouldn’t want everything done to save a loved one, or to prolong our time with a loved one? Who wouldn’t want everything done that might maximize the opportunity for recovery? And who would ever want to do nothing for a loved one in a medical crisis?

I have witnessed (and participated in) two responses to these challenging moments. The first is to acquiesce and perform an operation as a "last-ditch effort." The second is to simply refuse to intervene or even refuse the consult. Neither of these approaches is serves the patient, his or her family, or the health care team (including ourselves). To simply acquiesce puts the patient at increased risk of suffering, gives the family a false notion of hope, and creates moral distress in our team. To simply refuse and walk away leads to patient and family abandonment (with a lack of understanding why operative intervention is not indicated) and leads to conflict within our health care team.

I suggest we enter these situations with the premise that we always do everything and we never do nothing. We do our best to provide treatments to meet the goals and needs of our patients and their loved ones. At times, this may mean a surgical intervention to restore a patient to full premorbid health. At others, this may mean an operation to alleviate suffering, for example, from a malignant bowel obstruction. And sometimes this means not operating as it will only increase or prolong suffering. Yet in the latter situation, there are plenty of appropriate interventions: relieving pain or dyspnea, providing spiritual support, promoting bereavement, and assisting all participants in avoiding complicated grief. These therapies can and should be provided with the same aggressive approach with which we provide operative therapy.

With this approach we are able to reassure our patients and their loved ones that our interests lie in providing the best possible treatments in meeting their goals and needs. And that no matter what, we will find a means to help in some way.

As we sat in the emergency department, we reassured DR that we were there to help and find the best course of action. We admitted our uncertainty with the immediate prognosis with or without operative intervention, but that ultimately she was dying from the cancer. She expressed that she was not ready to die. "I hope we can avoid death as long as possible," I said. "While I am unsure which course of action will prolong your life the most, I am concerned that with operation your death has a higher likelihood of occurring in the midst of a prolonged ICU stay. If we try antibiotic therapy and pain control you might have more of an opportunity to spend time with your daughter and friends." We recommended avoiding operation, focusing on symptom management, and maximizing time with her loved ones.

DR wanted time. She was admitted for antibiotic therapy and aggressive symptom control with a consult to palliative medicine. She stabilized and was able to be transitioned to home hospice with her daughter and friend as caretakers.

This approach is effectively one of risk and benefit, recognition of uncertainty, and adherence to patient values. We recognize the inevitability of death from the beginning of a serious illness and openly discuss with our patients their fears and goals. We join with them in the uncertain future and the hard decisions to come. We work with patients to embrace life-enhancing therapies and to forgo death-avoiding therapies in order to maximize those that work toward patient-centered outcomes. This is a world in which we aggressively do everything to promote health, broadly defined, and ameliorate suffering. We always do everything.

Dr. Weinstein is an ACS Fellow and associate professor of surgery at Thomas Jefferson University in Philadelphia. He is director of the surgical intensive care unit and Executive Medical Co-Director of the Thomas Jefferson University Hospital Center for Critical Care. He is a member of the Palliative Care Task Force of the American College of Surgeons.

We were called to the emergency department to see a young woman, DR, with metastatic endometrial cancer. She had presented with abdominal pain and was found to have evidence of perforation on CT imaging. The CT also demonstrated the unresectable uterus and multiple peritoneal implants. The tumor had not been responsive to the last bout of chemotherapy. DR had been less active, and had lost significant weight over the last several months. A former real estate agent, she hadn’t worked since her diagnosis. She lived with a friend and had a daughter who was very worried about her condition.

I was also worried. After looking at the CT I had told the resident over the phone that operation might not be a great choice. Yes but the family "wants everything done," she replied... CRINGE. "I’ll be over," I said.

Why do we cringe at this statement? Perhaps we feel trapped by a family (or a medical team) who suggests we do everything. There is no out. The die has been cast. This is certainly the case when a non-surgical team has suggested to a family the option of a last-ditch operative intervention. What scares us about the family who wants "everything done"? Often, we don’t think we should be intervening with a surgical operation when the outcome appears dismal. We are concerned with litigation if we don’t try "everything." We fear the communication challenge of speaking with a family with "unrealistic expectations."

But if we take a step back, we might gain some appreciation for the family perspective. Who wouldn’t want everything done to save a loved one, or to prolong our time with a loved one? Who wouldn’t want everything done that might maximize the opportunity for recovery? And who would ever want to do nothing for a loved one in a medical crisis?

I have witnessed (and participated in) two responses to these challenging moments. The first is to acquiesce and perform an operation as a "last-ditch effort." The second is to simply refuse to intervene or even refuse the consult. Neither of these approaches is serves the patient, his or her family, or the health care team (including ourselves). To simply acquiesce puts the patient at increased risk of suffering, gives the family a false notion of hope, and creates moral distress in our team. To simply refuse and walk away leads to patient and family abandonment (with a lack of understanding why operative intervention is not indicated) and leads to conflict within our health care team.

I suggest we enter these situations with the premise that we always do everything and we never do nothing. We do our best to provide treatments to meet the goals and needs of our patients and their loved ones. At times, this may mean a surgical intervention to restore a patient to full premorbid health. At others, this may mean an operation to alleviate suffering, for example, from a malignant bowel obstruction. And sometimes this means not operating as it will only increase or prolong suffering. Yet in the latter situation, there are plenty of appropriate interventions: relieving pain or dyspnea, providing spiritual support, promoting bereavement, and assisting all participants in avoiding complicated grief. These therapies can and should be provided with the same aggressive approach with which we provide operative therapy.

With this approach we are able to reassure our patients and their loved ones that our interests lie in providing the best possible treatments in meeting their goals and needs. And that no matter what, we will find a means to help in some way.

As we sat in the emergency department, we reassured DR that we were there to help and find the best course of action. We admitted our uncertainty with the immediate prognosis with or without operative intervention, but that ultimately she was dying from the cancer. She expressed that she was not ready to die. "I hope we can avoid death as long as possible," I said. "While I am unsure which course of action will prolong your life the most, I am concerned that with operation your death has a higher likelihood of occurring in the midst of a prolonged ICU stay. If we try antibiotic therapy and pain control you might have more of an opportunity to spend time with your daughter and friends." We recommended avoiding operation, focusing on symptom management, and maximizing time with her loved ones.

DR wanted time. She was admitted for antibiotic therapy and aggressive symptom control with a consult to palliative medicine. She stabilized and was able to be transitioned to home hospice with her daughter and friend as caretakers.

This approach is effectively one of risk and benefit, recognition of uncertainty, and adherence to patient values. We recognize the inevitability of death from the beginning of a serious illness and openly discuss with our patients their fears and goals. We join with them in the uncertain future and the hard decisions to come. We work with patients to embrace life-enhancing therapies and to forgo death-avoiding therapies in order to maximize those that work toward patient-centered outcomes. This is a world in which we aggressively do everything to promote health, broadly defined, and ameliorate suffering. We always do everything.

Dr. Weinstein is an ACS Fellow and associate professor of surgery at Thomas Jefferson University in Philadelphia. He is director of the surgical intensive care unit and Executive Medical Co-Director of the Thomas Jefferson University Hospital Center for Critical Care. He is a member of the Palliative Care Task Force of the American College of Surgeons.

Electronic health records have led to recent issues appearing in the court system that can potentially convolute physician defense. Both health care attorneys and physicians are grappling with new technology that brings with it the need for close attention to new areas of detail. Certain habits, or lack of habits, can affect the medical-legal environment. Physicians who are aware of these issues can take steps to reduce their exposure.

One of the largest problems seen with EHRs is the failure of physicians to review dictated records. After a note is dictated into the electronic system, health care providers should be encouraged to read it and any accompanying documentation such as prescriptions.

Voice recognition systems are not foolproof and can lead to inaccuracies in the transcription of operative reports, office notes, and prescriptions. When a doctor is deposed and has to explain that what the record says is not really what he or she meant it to say, it decreases his or her credibility with the jury and undermines subsequent testimony. When a physician says that the record is not an accurate representation of what occurred, the jury is left with an impression of carelessness and a failure on the doctor’s part to take the time to ensure patient safety. Taking a few minutes to guarantee the accuracy of the record at the time of creation can save years of explanation after a case has been instituted.

The failure of the physician to review his or her notes can also lead to the veracity of the EHR being called into question. We are aware of at least one case in which an emergency department physician was asked to testify at trial about her interaction with a patient from many years prior. Understandably, the emergency department physician did not have a recollection of the visit and intended to rely on the record. The EHR documented the care that was provided, but the physicians had not signed it. At trial, the doctor was not allowed to testify about what she did for the patient. The rationale was that the doctor did not recall what was done, and her failure to sign the EHR contemporaneously meant that there was no evidence that the EHR was accurate.

A physician should be able to say that his or her custom and practice is to review the EHR before it is finalized and make any updates or addendums as needed. That way, even if there is no signature, the physician has given credence to the accuracy of the records.

Health care providers should be encouraged to use the "free-text" section that is available when it adds to the accuracy of the record. Often, the "drop box" does not provide an adequate selection to describe the history or physical. In anesthesia cases, for instance, the EHR drop box may allow only a description of "awake," "drowsy," or "unresponsive." These choices, while true, do not give an accurate picture of the patient. If a patient in the postanesthesia care unit is technically awake but not properly responsive, that should be documented.

Similarly, in the primary care physician’s office there are times when the general description of how a patient is looking can be informative and integral to the physician formulating an assessment. An example might be the case of a sick child. The child may be curious, playful, and smiling when pulling at the stethoscope. If we are using that information as an important part of our decision as to whether or not that child is seriously ill, then that level of detail should be included in the record. The term "NAD" (no acute distress) does not reflect the level of observation that influenced the decision not to do further testing.

If the drop box is the only source of information utilized, then the true description of the patient is not contained within the records. Sometimes, the most important bits of information cannot be explained utilizing drop boxes.

Another common issue is the failure of EHRs to document when a patient calls the physician’s office but is not actually seen for an appointment. The patient alleges that he or she called the doctor multiple times to report a problem. The HER, however, may not have any record of such a phone call. Physicians need to ensure that they are made aware of these telephone calls and that some type of note is made. The note should not just indicate that a call was made but also should document the physician response and recommendations.

Finally, a new area of concern that has emerged is failure to follow up on a recommendation once it has been made. An ideal situation would be for the EHR or physician office to send a follow-up reminder if an important test is not done. This reminder to the patient should be recorded as well as whether the patient went through with the recommendation and steps the health care provider took to encourage compliance.

This overview does not represent an exhaustive list of EHR issues but rather highlights some common issues along with steps that can be taken to minimize errors, with a goal of increasing overall safety for the patient and decreasing liability for the health care provider.

Mr. Marcoz is a health care attorney in Wilmington, Del., who is shareholder at Marshall Dennehey Warner Coleman & Goggin in the Health Care Liability Practice Group. His areas of practice include medical malpractice and dental insurance defense. Dr. Skolnik is associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital and professor of family and community medicine at Temple University, Philadelphia. He is also editor-in-chief of Redi-Reference Inc., a software company that creates mobile apps.

Electronic health records have led to recent issues appearing in the court system that can potentially convolute physician defense. Both health care attorneys and physicians are grappling with new technology that brings with it the need for close attention to new areas of detail. Certain habits, or lack of habits, can affect the medical-legal environment. Physicians who are aware of these issues can take steps to reduce their exposure.

One of the largest problems seen with EHRs is the failure of physicians to review dictated records. After a note is dictated into the electronic system, health care providers should be encouraged to read it and any accompanying documentation such as prescriptions.

Voice recognition systems are not foolproof and can lead to inaccuracies in the transcription of operative reports, office notes, and prescriptions. When a doctor is deposed and has to explain that what the record says is not really what he or she meant it to say, it decreases his or her credibility with the jury and undermines subsequent testimony. When a physician says that the record is not an accurate representation of what occurred, the jury is left with an impression of carelessness and a failure on the doctor’s part to take the time to ensure patient safety. Taking a few minutes to guarantee the accuracy of the record at the time of creation can save years of explanation after a case has been instituted.

The failure of the physician to review his or her notes can also lead to the veracity of the EHR being called into question. We are aware of at least one case in which an emergency department physician was asked to testify at trial about her interaction with a patient from many years prior. Understandably, the emergency department physician did not have a recollection of the visit and intended to rely on the record. The EHR documented the care that was provided, but the physicians had not signed it. At trial, the doctor was not allowed to testify about what she did for the patient. The rationale was that the doctor did not recall what was done, and her failure to sign the EHR contemporaneously meant that there was no evidence that the EHR was accurate.

A physician should be able to say that his or her custom and practice is to review the EHR before it is finalized and make any updates or addendums as needed. That way, even if there is no signature, the physician has given credence to the accuracy of the records.

Health care providers should be encouraged to use the "free-text" section that is available when it adds to the accuracy of the record. Often, the "drop box" does not provide an adequate selection to describe the history or physical. In anesthesia cases, for instance, the EHR drop box may allow only a description of "awake," "drowsy," or "unresponsive." These choices, while true, do not give an accurate picture of the patient. If a patient in the postanesthesia care unit is technically awake but not properly responsive, that should be documented.

Similarly, in the primary care physician’s office there are times when the general description of how a patient is looking can be informative and integral to the physician formulating an assessment. An example might be the case of a sick child. The child may be curious, playful, and smiling when pulling at the stethoscope. If we are using that information as an important part of our decision as to whether or not that child is seriously ill, then that level of detail should be included in the record. The term "NAD" (no acute distress) does not reflect the level of observation that influenced the decision not to do further testing.

If the drop box is the only source of information utilized, then the true description of the patient is not contained within the records. Sometimes, the most important bits of information cannot be explained utilizing drop boxes.

Another common issue is the failure of EHRs to document when a patient calls the physician’s office but is not actually seen for an appointment. The patient alleges that he or she called the doctor multiple times to report a problem. The HER, however, may not have any record of such a phone call. Physicians need to ensure that they are made aware of these telephone calls and that some type of note is made. The note should not just indicate that a call was made but also should document the physician response and recommendations.

Finally, a new area of concern that has emerged is failure to follow up on a recommendation once it has been made. An ideal situation would be for the EHR or physician office to send a follow-up reminder if an important test is not done. This reminder to the patient should be recorded as well as whether the patient went through with the recommendation and steps the health care provider took to encourage compliance.

This overview does not represent an exhaustive list of EHR issues but rather highlights some common issues along with steps that can be taken to minimize errors, with a goal of increasing overall safety for the patient and decreasing liability for the health care provider.

Mr. Marcoz is a health care attorney in Wilmington, Del., who is shareholder at Marshall Dennehey Warner Coleman & Goggin in the Health Care Liability Practice Group. His areas of practice include medical malpractice and dental insurance defense. Dr. Skolnik is associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital and professor of family and community medicine at Temple University, Philadelphia. He is also editor-in-chief of Redi-Reference Inc., a software company that creates mobile apps.

Electronic health records have led to recent issues appearing in the court system that can potentially convolute physician defense. Both health care attorneys and physicians are grappling with new technology that brings with it the need for close attention to new areas of detail. Certain habits, or lack of habits, can affect the medical-legal environment. Physicians who are aware of these issues can take steps to reduce their exposure.

One of the largest problems seen with EHRs is the failure of physicians to review dictated records. After a note is dictated into the electronic system, health care providers should be encouraged to read it and any accompanying documentation such as prescriptions.

Voice recognition systems are not foolproof and can lead to inaccuracies in the transcription of operative reports, office notes, and prescriptions. When a doctor is deposed and has to explain that what the record says is not really what he or she meant it to say, it decreases his or her credibility with the jury and undermines subsequent testimony. When a physician says that the record is not an accurate representation of what occurred, the jury is left with an impression of carelessness and a failure on the doctor’s part to take the time to ensure patient safety. Taking a few minutes to guarantee the accuracy of the record at the time of creation can save years of explanation after a case has been instituted.

The failure of the physician to review his or her notes can also lead to the veracity of the EHR being called into question. We are aware of at least one case in which an emergency department physician was asked to testify at trial about her interaction with a patient from many years prior. Understandably, the emergency department physician did not have a recollection of the visit and intended to rely on the record. The EHR documented the care that was provided, but the physicians had not signed it. At trial, the doctor was not allowed to testify about what she did for the patient. The rationale was that the doctor did not recall what was done, and her failure to sign the EHR contemporaneously meant that there was no evidence that the EHR was accurate.

A physician should be able to say that his or her custom and practice is to review the EHR before it is finalized and make any updates or addendums as needed. That way, even if there is no signature, the physician has given credence to the accuracy of the records.

Health care providers should be encouraged to use the "free-text" section that is available when it adds to the accuracy of the record. Often, the "drop box" does not provide an adequate selection to describe the history or physical. In anesthesia cases, for instance, the EHR drop box may allow only a description of "awake," "drowsy," or "unresponsive." These choices, while true, do not give an accurate picture of the patient. If a patient in the postanesthesia care unit is technically awake but not properly responsive, that should be documented.

Similarly, in the primary care physician’s office there are times when the general description of how a patient is looking can be informative and integral to the physician formulating an assessment. An example might be the case of a sick child. The child may be curious, playful, and smiling when pulling at the stethoscope. If we are using that information as an important part of our decision as to whether or not that child is seriously ill, then that level of detail should be included in the record. The term "NAD" (no acute distress) does not reflect the level of observation that influenced the decision not to do further testing.

If the drop box is the only source of information utilized, then the true description of the patient is not contained within the records. Sometimes, the most important bits of information cannot be explained utilizing drop boxes.

Another common issue is the failure of EHRs to document when a patient calls the physician’s office but is not actually seen for an appointment. The patient alleges that he or she called the doctor multiple times to report a problem. The HER, however, may not have any record of such a phone call. Physicians need to ensure that they are made aware of these telephone calls and that some type of note is made. The note should not just indicate that a call was made but also should document the physician response and recommendations.

Finally, a new area of concern that has emerged is failure to follow up on a recommendation once it has been made. An ideal situation would be for the EHR or physician office to send a follow-up reminder if an important test is not done. This reminder to the patient should be recorded as well as whether the patient went through with the recommendation and steps the health care provider took to encourage compliance.

This overview does not represent an exhaustive list of EHR issues but rather highlights some common issues along with steps that can be taken to minimize errors, with a goal of increasing overall safety for the patient and decreasing liability for the health care provider.

Mr. Marcoz is a health care attorney in Wilmington, Del., who is shareholder at Marshall Dennehey Warner Coleman & Goggin in the Health Care Liability Practice Group. His areas of practice include medical malpractice and dental insurance defense. Dr. Skolnik is associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital and professor of family and community medicine at Temple University, Philadelphia. He is also editor-in-chief of Redi-Reference Inc., a software company that creates mobile apps.

Clinical question: What are the characteristics of a large cohort of patients under observation status?

Background: The use of observation hospital services has increased significantly. The Centers for Medicare and Medicaid Services (CMS) defines observation status as a “well-defined set of specific, clinically appropriate services,” usually lasting <24 hours and exceeding 48 hours in “only rare and exceptional cases.”

Study design: Retrospective descriptive study.

Setting: University of Wisconsin Hospital and Clinics, a 566-bed tertiary academic medical center.

Synopsis: A total of 43,853 hospitalizations were reviewed during the study period. Of those, 4578 (10.4%) were observation. The mean observation LOS was 33.3 hours, which included 16.5% of patients with LOS >48 hours. Although chest pain was the top observation diagnosis, 1141 distinct observation diagnosis codes were found.

These findings illustrate a significant disparity between the CMS definition for observation stay and the description of observation patients in this cohort, despite using CMS-endorsed InterQual criteria to determine status. While the cost per encounter for observation care was less than inpatient care, reimbursement was insufficient to cover those reduced costs. Ultimately, the net loss of revenue per observation encounter was $331, compared to a net gain in revenue per inpatient encounter of $2,163. This operating loss for hospitals is coupled with the fact that some of this cost is being transferred to patients.

Bottom line: Definitions and reimbursement models for observation status warrant continued research and discussion in the context of our evolving healthcare climate.

Citation: Sheehy AM, Graf B, Gangireddy S, et al. Hospitalized but not admitted: characteristics of patients with “observation status” at an academic medical center [published online ahead of print July 8, 2013]. JAMA Intern Med.

Clinical question: What are the characteristics of a large cohort of patients under observation status?

Background: The use of observation hospital services has increased significantly. The Centers for Medicare and Medicaid Services (CMS) defines observation status as a “well-defined set of specific, clinically appropriate services,” usually lasting <24 hours and exceeding 48 hours in “only rare and exceptional cases.”

Study design: Retrospective descriptive study.

Setting: University of Wisconsin Hospital and Clinics, a 566-bed tertiary academic medical center.

Synopsis: A total of 43,853 hospitalizations were reviewed during the study period. Of those, 4578 (10.4%) were observation. The mean observation LOS was 33.3 hours, which included 16.5% of patients with LOS >48 hours. Although chest pain was the top observation diagnosis, 1141 distinct observation diagnosis codes were found.

These findings illustrate a significant disparity between the CMS definition for observation stay and the description of observation patients in this cohort, despite using CMS-endorsed InterQual criteria to determine status. While the cost per encounter for observation care was less than inpatient care, reimbursement was insufficient to cover those reduced costs. Ultimately, the net loss of revenue per observation encounter was $331, compared to a net gain in revenue per inpatient encounter of $2,163. This operating loss for hospitals is coupled with the fact that some of this cost is being transferred to patients.

Bottom line: Definitions and reimbursement models for observation status warrant continued research and discussion in the context of our evolving healthcare climate.

Citation: Sheehy AM, Graf B, Gangireddy S, et al. Hospitalized but not admitted: characteristics of patients with “observation status” at an academic medical center [published online ahead of print July 8, 2013]. JAMA Intern Med.

Clinical question: What are the characteristics of a large cohort of patients under observation status?

Background: The use of observation hospital services has increased significantly. The Centers for Medicare and Medicaid Services (CMS) defines observation status as a “well-defined set of specific, clinically appropriate services,” usually lasting <24 hours and exceeding 48 hours in “only rare and exceptional cases.”

Study design: Retrospective descriptive study.

Setting: University of Wisconsin Hospital and Clinics, a 566-bed tertiary academic medical center.

Synopsis: A total of 43,853 hospitalizations were reviewed during the study period. Of those, 4578 (10.4%) were observation. The mean observation LOS was 33.3 hours, which included 16.5% of patients with LOS >48 hours. Although chest pain was the top observation diagnosis, 1141 distinct observation diagnosis codes were found.

These findings illustrate a significant disparity between the CMS definition for observation stay and the description of observation patients in this cohort, despite using CMS-endorsed InterQual criteria to determine status. While the cost per encounter for observation care was less than inpatient care, reimbursement was insufficient to cover those reduced costs. Ultimately, the net loss of revenue per observation encounter was $331, compared to a net gain in revenue per inpatient encounter of $2,163. This operating loss for hospitals is coupled with the fact that some of this cost is being transferred to patients.

Bottom line: Definitions and reimbursement models for observation status warrant continued research and discussion in the context of our evolving healthcare climate.

Citation: Sheehy AM, Graf B, Gangireddy S, et al. Hospitalized but not admitted: characteristics of patients with “observation status” at an academic medical center [published online ahead of print July 8, 2013]. JAMA Intern Med.

Clinical question: Is early surgery associated with better survival in patients with prosthetic valve endocarditis (PVE)?

Background: PVE occurs in 3% to 6% of patients within five years of valve implantation. Consensus guidelines, based on expert opinion, recommend surgical intervention with debridement and valve replacement in PVE, especially for patients with complications that are unlikely to be successfully treated with medical therapy, such as valve dysfunction, heart failure, and cardiac abscesses. Studies comparing survival with medical therapy versus surgery have reported conflicting results.

Study Design: Multi-center, prospective, cohort study.

Setting: International, multi-center cohort of patients from tertiary care hospitals.

Synopsis: The International Collaboration on Endocarditis—Prospective Cohort Study (ICE-PCS) cohort consisted of 1025 patients with PVE, 490 of whom underwent early surgery and 535 of whom received medical therapy alone.

Unadjusted initial analysis showed early surgery was associated with lower mortality; however, this survival benefit was not evident after the data was adjusted for treatment selection bias and survivor bias for in-hospital mortality and one-year mortality. The hazard ratios were 0.9 (95% CI 0.76 -1.07) and 1.04 (95% CI 0.89 -1.23), respectively.

Subgroup analysis indicated that early surgery in patients with high-risk features was associated with fewer poor outcomes compared to medical therapy: 28% versus 50% (P=.007)

Bottom line: Early surgery may not be associated with mortality benefits for PVE. High-risk patients, however, still might benefit from early surgery.

Citation: Lalani T, Chu VH, Park LP, et al. In-hospital and 1-year mortality in patients undergoing early surgery for prosthetic valve endocarditis. JAMA Intern Med. 2013:173:1495-1504.

Clinical question: Is early surgery associated with better survival in patients with prosthetic valve endocarditis (PVE)?

Background: PVE occurs in 3% to 6% of patients within five years of valve implantation. Consensus guidelines, based on expert opinion, recommend surgical intervention with debridement and valve replacement in PVE, especially for patients with complications that are unlikely to be successfully treated with medical therapy, such as valve dysfunction, heart failure, and cardiac abscesses. Studies comparing survival with medical therapy versus surgery have reported conflicting results.

Study Design: Multi-center, prospective, cohort study.

Setting: International, multi-center cohort of patients from tertiary care hospitals.

Synopsis: The International Collaboration on Endocarditis—Prospective Cohort Study (ICE-PCS) cohort consisted of 1025 patients with PVE, 490 of whom underwent early surgery and 535 of whom received medical therapy alone.

Unadjusted initial analysis showed early surgery was associated with lower mortality; however, this survival benefit was not evident after the data was adjusted for treatment selection bias and survivor bias for in-hospital mortality and one-year mortality. The hazard ratios were 0.9 (95% CI 0.76 -1.07) and 1.04 (95% CI 0.89 -1.23), respectively.

Subgroup analysis indicated that early surgery in patients with high-risk features was associated with fewer poor outcomes compared to medical therapy: 28% versus 50% (P=.007)

Bottom line: Early surgery may not be associated with mortality benefits for PVE. High-risk patients, however, still might benefit from early surgery.

Citation: Lalani T, Chu VH, Park LP, et al. In-hospital and 1-year mortality in patients undergoing early surgery for prosthetic valve endocarditis. JAMA Intern Med. 2013:173:1495-1504.

Clinical question: Is early surgery associated with better survival in patients with prosthetic valve endocarditis (PVE)?

Background: PVE occurs in 3% to 6% of patients within five years of valve implantation. Consensus guidelines, based on expert opinion, recommend surgical intervention with debridement and valve replacement in PVE, especially for patients with complications that are unlikely to be successfully treated with medical therapy, such as valve dysfunction, heart failure, and cardiac abscesses. Studies comparing survival with medical therapy versus surgery have reported conflicting results.

Study Design: Multi-center, prospective, cohort study.

Setting: International, multi-center cohort of patients from tertiary care hospitals.

Synopsis: The International Collaboration on Endocarditis—Prospective Cohort Study (ICE-PCS) cohort consisted of 1025 patients with PVE, 490 of whom underwent early surgery and 535 of whom received medical therapy alone.

Unadjusted initial analysis showed early surgery was associated with lower mortality; however, this survival benefit was not evident after the data was adjusted for treatment selection bias and survivor bias for in-hospital mortality and one-year mortality. The hazard ratios were 0.9 (95% CI 0.76 -1.07) and 1.04 (95% CI 0.89 -1.23), respectively.

Subgroup analysis indicated that early surgery in patients with high-risk features was associated with fewer poor outcomes compared to medical therapy: 28% versus 50% (P=.007)

Bottom line: Early surgery may not be associated with mortality benefits for PVE. High-risk patients, however, still might benefit from early surgery.

Citation: Lalani T, Chu VH, Park LP, et al. In-hospital and 1-year mortality in patients undergoing early surgery for prosthetic valve endocarditis. JAMA Intern Med. 2013:173:1495-1504.

Clinical question: What steps can hospitals take to reduce readmission rates in patients with heart failure?

Background: Evidence about various hospital strategies to decrease readmissions in patients with heart failure is limited.

Study Design: Cross-sectional study using a web-based survey.

Setting: Survey of 599 hospitals participating in quality initiatives to reduce readmissions.

Synopsis: Readmission of patients with heart failure is common and costly. Hospitals with high readmissions can lose up to 3% of their Medicare reimbursements by 2015.

This study found six strategies associated with lower risk-standardized 30-day readmission rates.

1. Partnering with community physicians and physician groups (0.33%; P=0.017);
2. Partnering with local hospitals (0.34%; P=0.020);
3. Having nurses responsible for medication reconciliation (0.18%; P=0.002);
4. Arranging follow-up visit before discharge (0.19%; P=0.037);
5. Having a process in place to send all discharge summaries directly to the patient’s primary care physician (0.21%; P=0.004); and
6. Assigning staff to follow up on test results after the patient is discharged (0.26%; P=0.049).

Individually, the magnitude of the effects was modest, but implementing multiple strategies was more beneficial (0.34% additional benefit for each additional strategy). Only 7% of the hospitals surveyed implemented all six strategies, highlighting substantial opportunities for improvement.

Bottom line: Implementing multiple strategies may help reduce readmission in patients with heart failure.

Citation: Bradley EH, Curry L, Horwitz LI, et al. Hospital strategies associated with 30-day readmission rates for patients with heart failure. Circ Cardiovasc Qual Outcomes. 2013;6:444-450.

Clinical question: What steps can hospitals take to reduce readmission rates in patients with heart failure?

Background: Evidence about various hospital strategies to decrease readmissions in patients with heart failure is limited.

Study Design: Cross-sectional study using a web-based survey.

Setting: Survey of 599 hospitals participating in quality initiatives to reduce readmissions.

Synopsis: Readmission of patients with heart failure is common and costly. Hospitals with high readmissions can lose up to 3% of their Medicare reimbursements by 2015.

This study found six strategies associated with lower risk-standardized 30-day readmission rates.

1. Partnering with community physicians and physician groups (0.33%; P=0.017);
2. Partnering with local hospitals (0.34%; P=0.020);
3. Having nurses responsible for medication reconciliation (0.18%; P=0.002);
4. Arranging follow-up visit before discharge (0.19%; P=0.037);
5. Having a process in place to send all discharge summaries directly to the patient’s primary care physician (0.21%; P=0.004); and
6. Assigning staff to follow up on test results after the patient is discharged (0.26%; P=0.049).

Individually, the magnitude of the effects was modest, but implementing multiple strategies was more beneficial (0.34% additional benefit for each additional strategy). Only 7% of the hospitals surveyed implemented all six strategies, highlighting substantial opportunities for improvement.

Bottom line: Implementing multiple strategies may help reduce readmission in patients with heart failure.

Citation: Bradley EH, Curry L, Horwitz LI, et al. Hospital strategies associated with 30-day readmission rates for patients with heart failure. Circ Cardiovasc Qual Outcomes. 2013;6:444-450.

Clinical question: What steps can hospitals take to reduce readmission rates in patients with heart failure?

Background: Evidence about various hospital strategies to decrease readmissions in patients with heart failure is limited.

Study Design: Cross-sectional study using a web-based survey.

Setting: Survey of 599 hospitals participating in quality initiatives to reduce readmissions.

Synopsis: Readmission of patients with heart failure is common and costly. Hospitals with high readmissions can lose up to 3% of their Medicare reimbursements by 2015.

This study found six strategies associated with lower risk-standardized 30-day readmission rates.

1. Partnering with community physicians and physician groups (0.33%; P=0.017);
2. Partnering with local hospitals (0.34%; P=0.020);
3. Having nurses responsible for medication reconciliation (0.18%; P=0.002);
4. Arranging follow-up visit before discharge (0.19%; P=0.037);
5. Having a process in place to send all discharge summaries directly to the patient’s primary care physician (0.21%; P=0.004); and
6. Assigning staff to follow up on test results after the patient is discharged (0.26%; P=0.049).

Individually, the magnitude of the effects was modest, but implementing multiple strategies was more beneficial (0.34% additional benefit for each additional strategy). Only 7% of the hospitals surveyed implemented all six strategies, highlighting substantial opportunities for improvement.

Bottom line: Implementing multiple strategies may help reduce readmission in patients with heart failure.

Citation: Bradley EH, Curry L, Horwitz LI, et al. Hospital strategies associated with 30-day readmission rates for patients with heart failure. Circ Cardiovasc Qual Outcomes. 2013;6:444-450.

Clinical question: Do programs that systematically provide smoking cessation support to admitted patients improve smoking cessation rates?

Background: Hospitalization is a good setting for initiation of smoking cessation. It is well known that conventional behavioral and pharmacotherapy interventions are effective. Intensive behavioral intervention provided to willing hospitalized patients is known to be useful; however, there is no established systematic delivery of these interventions.

Study design: Open, cluster-randomized, controlled trial.

Setting: Acute medical wards in a large teaching hospital in the United Kingdom.

Synopsis: More than 1,000 patients admitted between October 2010 and August 2011 were eligible for the study, of which 264 were included in the intervention and 229 in the usual care group (determination of smoking status and non-obligatory offer of cessation support). All of those in intervention received advice to quit smoking, compared to only 46% in the usual care group. Four-week smoking cessation was achieved by 38% of patients from the intervention group, compared to 17% from the usual care group. Secondary outcomes (use of behavioral cessation support, pharmacotherapy, and referral to and use of the local stop smoking service) were all significantly higher in the intervention group compared to the usual care group (P<0.001 in all cases).

This study shows that simple measures, when systematically delivered, are effective in initiating smoking cessation.

Bottom line: In-hospital systematic delivery of smoking cessation strategies is effective.

Citation: Murray RL, Leonardi-Bee J, Marsh J, et al. Systematic identification and treatment of smokers by hospital based cessation practitioners in a secondary care setting: cluster randomised controlled trial. BMJ. 2013;347:f4004.

Clinical question: Do programs that systematically provide smoking cessation support to admitted patients improve smoking cessation rates?

Background: Hospitalization is a good setting for initiation of smoking cessation. It is well known that conventional behavioral and pharmacotherapy interventions are effective. Intensive behavioral intervention provided to willing hospitalized patients is known to be useful; however, there is no established systematic delivery of these interventions.

Study design: Open, cluster-randomized, controlled trial.

Setting: Acute medical wards in a large teaching hospital in the United Kingdom.

Synopsis: More than 1,000 patients admitted between October 2010 and August 2011 were eligible for the study, of which 264 were included in the intervention and 229 in the usual care group (determination of smoking status and non-obligatory offer of cessation support). All of those in intervention received advice to quit smoking, compared to only 46% in the usual care group. Four-week smoking cessation was achieved by 38% of patients from the intervention group, compared to 17% from the usual care group. Secondary outcomes (use of behavioral cessation support, pharmacotherapy, and referral to and use of the local stop smoking service) were all significantly higher in the intervention group compared to the usual care group (P<0.001 in all cases).

This study shows that simple measures, when systematically delivered, are effective in initiating smoking cessation.

Bottom line: In-hospital systematic delivery of smoking cessation strategies is effective.

Citation: Murray RL, Leonardi-Bee J, Marsh J, et al. Systematic identification and treatment of smokers by hospital based cessation practitioners in a secondary care setting: cluster randomised controlled trial. BMJ. 2013;347:f4004.

Clinical question: Do programs that systematically provide smoking cessation support to admitted patients improve smoking cessation rates?

Background: Hospitalization is a good setting for initiation of smoking cessation. It is well known that conventional behavioral and pharmacotherapy interventions are effective. Intensive behavioral intervention provided to willing hospitalized patients is known to be useful; however, there is no established systematic delivery of these interventions.

Study design: Open, cluster-randomized, controlled trial.

Setting: Acute medical wards in a large teaching hospital in the United Kingdom.

Synopsis: More than 1,000 patients admitted between October 2010 and August 2011 were eligible for the study, of which 264 were included in the intervention and 229 in the usual care group (determination of smoking status and non-obligatory offer of cessation support). All of those in intervention received advice to quit smoking, compared to only 46% in the usual care group. Four-week smoking cessation was achieved by 38% of patients from the intervention group, compared to 17% from the usual care group. Secondary outcomes (use of behavioral cessation support, pharmacotherapy, and referral to and use of the local stop smoking service) were all significantly higher in the intervention group compared to the usual care group (P<0.001 in all cases).

This study shows that simple measures, when systematically delivered, are effective in initiating smoking cessation.

Bottom line: In-hospital systematic delivery of smoking cessation strategies is effective.

Citation: Murray RL, Leonardi-Bee J, Marsh J, et al. Systematic identification and treatment of smokers by hospital based cessation practitioners in a secondary care setting: cluster randomised controlled trial. BMJ. 2013;347:f4004.

Clinical question: How have opioid pain reliever (OPR) prescriptions affected drug misuse or abuse and drug overdose deaths for women in the past decade?

Background: Overdose deaths have increased steadily over the past decade. More men die from drug overdoses, but the percentage of women dying from drug misuse has increased substantially.

Study design: Retrospective analysis.

Setting: Data from the National Vital Statistics System (NVSS) and the Drug Abuse Warning Network (DAWN).

Synopsis: The CDC analyzed death rates based on NVSS multiple causes of death from 1999-2010. Type of drug involved (OPR, cocaine, heroin, benzodiazepines) was based on ICD 10 codes. Analysis showed that deaths from OPRs between 1999 and 2010 increased five-fold in women, compared to 3.6-fold in men.

The CDC also analyzed DAWN data from ED visits by women for drug misuse or abuse between 2004-2010. When compared to data from 2004, the ED visits related to misuse or abuse of OPR among women more than doubled, and the rate of OPR deaths among women increased by 70%.

Limitations of this study include the fact that all drugs used were not identified, and motivation to use was unclear. Also, medical or non-medical reason for use was not always available.

Bottom line: Healthcare providers prescribing OPRs to patients should use their state’s prescription drug monitoring program and regularly screen patients for psychological disorders and use of psychotherapeutic drugs, with or without a prescription.

Citation: Centers for Disease Control and Prevention (CDC). Vital signs: overdoses of prescription opioid pain relievers and other drugs among women—United States, 1999-2010. MMWR Morb Mortal Wkly Rep. 2013;62:537-542.

Clinical question: How have opioid pain reliever (OPR) prescriptions affected drug misuse or abuse and drug overdose deaths for women in the past decade?

Background: Overdose deaths have increased steadily over the past decade. More men die from drug overdoses, but the percentage of women dying from drug misuse has increased substantially.

Study design: Retrospective analysis.

Setting: Data from the National Vital Statistics System (NVSS) and the Drug Abuse Warning Network (DAWN).

Synopsis: The CDC analyzed death rates based on NVSS multiple causes of death from 1999-2010. Type of drug involved (OPR, cocaine, heroin, benzodiazepines) was based on ICD 10 codes. Analysis showed that deaths from OPRs between 1999 and 2010 increased five-fold in women, compared to 3.6-fold in men.

The CDC also analyzed DAWN data from ED visits by women for drug misuse or abuse between 2004-2010. When compared to data from 2004, the ED visits related to misuse or abuse of OPR among women more than doubled, and the rate of OPR deaths among women increased by 70%.

Limitations of this study include the fact that all drugs used were not identified, and motivation to use was unclear. Also, medical or non-medical reason for use was not always available.

Bottom line: Healthcare providers prescribing OPRs to patients should use their state’s prescription drug monitoring program and regularly screen patients for psychological disorders and use of psychotherapeutic drugs, with or without a prescription.

Citation: Centers for Disease Control and Prevention (CDC). Vital signs: overdoses of prescription opioid pain relievers and other drugs among women—United States, 1999-2010. MMWR Morb Mortal Wkly Rep. 2013;62:537-542.

Clinical question: How have opioid pain reliever (OPR) prescriptions affected drug misuse or abuse and drug overdose deaths for women in the past decade?

Background: Overdose deaths have increased steadily over the past decade. More men die from drug overdoses, but the percentage of women dying from drug misuse has increased substantially.

Study design: Retrospective analysis.

Setting: Data from the National Vital Statistics System (NVSS) and the Drug Abuse Warning Network (DAWN).

Synopsis: The CDC analyzed death rates based on NVSS multiple causes of death from 1999-2010. Type of drug involved (OPR, cocaine, heroin, benzodiazepines) was based on ICD 10 codes. Analysis showed that deaths from OPRs between 1999 and 2010 increased five-fold in women, compared to 3.6-fold in men.

The CDC also analyzed DAWN data from ED visits by women for drug misuse or abuse between 2004-2010. When compared to data from 2004, the ED visits related to misuse or abuse of OPR among women more than doubled, and the rate of OPR deaths among women increased by 70%.

Limitations of this study include the fact that all drugs used were not identified, and motivation to use was unclear. Also, medical or non-medical reason for use was not always available.

Bottom line: Healthcare providers prescribing OPRs to patients should use their state’s prescription drug monitoring program and regularly screen patients for psychological disorders and use of psychotherapeutic drugs, with or without a prescription.

Citation: Centers for Disease Control and Prevention (CDC). Vital signs: overdoses of prescription opioid pain relievers and other drugs among women—United States, 1999-2010. MMWR Morb Mortal Wkly Rep. 2013;62:537-542.

Clinical question: Does the use of a standardized suite of post-operative pulmonary care guidelines decrease the incidence of adverse pulmonary outcomes in non-ventilated patients?

Background: Post-operative pulmonary complications are common and account for high costs and increased length of stay. Best practice guidelines for pulmonary care in general for patients undergoing non-cardiac surgery are scarce, compared to strategies to prevent ventilator-associated pneumonia (VAP).

Study design: Observational study.

Setting: Boston University Medical Center.

Synopsis: The I COUGH program emphasized Incentive spirometry, Coughing and deep breathing, Oral care, Understanding (patient and family education), Getting out of bed at least three times daily, and Head-of-bed elevation.

I COUGH was implemented for one year for all general surgery and vascular surgery patients, and results were compared with the year prior using National Surgical Quality Improvement Program (NSQIP) data. The program reduced the incidence of post-operative pneumonia to 1.6% from 2.6% and the incidence of unplanned intubations to 1.2% from 2.0%. The results did show a trend but did not achieve statistical significance.

Bottom line: Post-operative implementation of I COUGH through consistent education of staff, patients, and family might reduce post-operative pneumonia and unplanned intubations.

Citation: Cassidy MR, Rosenkranz P, McCabe K, Rosen JE, McAneny D. I COUGH: reducing postoperative pulmonary complications with a multidisciplinary patient care program. JAMA Surg. 2013;148:740-745.

Clinical question: Does the use of a standardized suite of post-operative pulmonary care guidelines decrease the incidence of adverse pulmonary outcomes in non-ventilated patients?

Background: Post-operative pulmonary complications are common and account for high costs and increased length of stay. Best practice guidelines for pulmonary care in general for patients undergoing non-cardiac surgery are scarce, compared to strategies to prevent ventilator-associated pneumonia (VAP).

Study design: Observational study.

Setting: Boston University Medical Center.

Synopsis: The I COUGH program emphasized Incentive spirometry, Coughing and deep breathing, Oral care, Understanding (patient and family education), Getting out of bed at least three times daily, and Head-of-bed elevation.

I COUGH was implemented for one year for all general surgery and vascular surgery patients, and results were compared with the year prior using National Surgical Quality Improvement Program (NSQIP) data. The program reduced the incidence of post-operative pneumonia to 1.6% from 2.6% and the incidence of unplanned intubations to 1.2% from 2.0%. The results did show a trend but did not achieve statistical significance.

Bottom line: Post-operative implementation of I COUGH through consistent education of staff, patients, and family might reduce post-operative pneumonia and unplanned intubations.

Citation: Cassidy MR, Rosenkranz P, McCabe K, Rosen JE, McAneny D. I COUGH: reducing postoperative pulmonary complications with a multidisciplinary patient care program. JAMA Surg. 2013;148:740-745.

Clinical question: Does the use of a standardized suite of post-operative pulmonary care guidelines decrease the incidence of adverse pulmonary outcomes in non-ventilated patients?

Background: Post-operative pulmonary complications are common and account for high costs and increased length of stay. Best practice guidelines for pulmonary care in general for patients undergoing non-cardiac surgery are scarce, compared to strategies to prevent ventilator-associated pneumonia (VAP).

Study design: Observational study.

Setting: Boston University Medical Center.

Synopsis: The I COUGH program emphasized Incentive spirometry, Coughing and deep breathing, Oral care, Understanding (patient and family education), Getting out of bed at least three times daily, and Head-of-bed elevation.

I COUGH was implemented for one year for all general surgery and vascular surgery patients, and results were compared with the year prior using National Surgical Quality Improvement Program (NSQIP) data. The program reduced the incidence of post-operative pneumonia to 1.6% from 2.6% and the incidence of unplanned intubations to 1.2% from 2.0%. The results did show a trend but did not achieve statistical significance.

Bottom line: Post-operative implementation of I COUGH through consistent education of staff, patients, and family might reduce post-operative pneumonia and unplanned intubations.

Citation: Cassidy MR, Rosenkranz P, McCabe K, Rosen JE, McAneny D. I COUGH: reducing postoperative pulmonary complications with a multidisciplinary patient care program. JAMA Surg. 2013;148:740-745.