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Management of acute atrial fibrillation and atrial flutter in non-pregnant hospitalized adults.
Major Recommendations Note from the University of Michigan Health System (UMHS) and the National Guideline Clearinghouse (NGC): The following guidance was current as of May 2014. Because UMHS occasionally releases minor revisions to its guidance based on new information, users may wish to consult the original guideline document Note from NGC: The following key points summarize the content of the guideline. Refer to the full text of the original guideline document for detailed information on each of the screening procedures. The strength of recommendation (I-III) and levels of evidence (A-D) are defined at the end of the "Major Recommendations" field. Key Points Clinical Presentation Patients presenting with palpitations, irregular pulse, chest pain, dyspnea, fatigue, lightheadedness, syncope, cardio-embolic disease and new or recurrent heart failure should be evaluated for atrial fibrillation/atrial flutter (AF/AFL). While AF may be asymptomatic and found incidentally, AFL is usually highly symptomatic. Diagnosis Electrocardiogram (ECG) is essential in the diagnosis of AF/AFL. The initial evaluation is summarized in Table 1 in the original guideline document and should include:
Treatment Initial treatment of AF/AFL depends on hemodynamic stability. Unstable AF/AFL (refer to Figure 1 in the original guideline document):
Stable AF/AFL (refer to Figure 2 in the original guideline document):
Definitions: Levels of Evidence
Strength of Recommendation
Clinical Algorithm(s) The following algorithms are provided in the original guideline document:
An algorithm titled "Management of acute atrial fibrillation/flutter after thoracic surgery" is also provided in Appendix C in the original guideline document. |
Evidence Supporting the Recommendations Type of Evidence Supporting the Recommendations The type of supporting evidence is identified and graded for selected recommendations (see the "Major Recommendations" field). Conclusions were based on prospective randomized clinical trials (RCTs) if available, to the exclusion of other data; if RCTs were not available, observational studies were admitted to consideration. If no such data were available for a given link in the problem formulation, expert opinion was used to estimate effect size. |
Benefits/Harms of Implementing the Guideline Recommendations Potential Benefits It is hoped that standardization of care will result in improved patient outcomes, shorter length of hospital stay, lower readmission rates, and overall cost savings for the system. Potential Harms
Refer to Table 4 and Appendices A and B in the original guideline document for more information on specific drugs. |
Major Recommendations Note from the University of Michigan Health System (UMHS) and the National Guideline Clearinghouse (NGC): The following guidance was current as of May 2014. Because UMHS occasionally releases minor revisions to its guidance based on new information, users may wish to consult the original guideline document Note from NGC: The following key points summarize the content of the guideline. Refer to the full text of the original guideline document for detailed information on each of the screening procedures. The strength of recommendation (I-III) and levels of evidence (A-D) are defined at the end of the "Major Recommendations" field. Key Points Clinical Presentation Patients presenting with palpitations, irregular pulse, chest pain, dyspnea, fatigue, lightheadedness, syncope, cardio-embolic disease and new or recurrent heart failure should be evaluated for atrial fibrillation/atrial flutter (AF/AFL). While AF may be asymptomatic and found incidentally, AFL is usually highly symptomatic. Diagnosis Electrocardiogram (ECG) is essential in the diagnosis of AF/AFL. The initial evaluation is summarized in Table 1 in the original guideline document and should include:
Treatment Initial treatment of AF/AFL depends on hemodynamic stability. Unstable AF/AFL (refer to Figure 1 in the original guideline document):
Stable AF/AFL (refer to Figure 2 in the original guideline document):
Definitions: Levels of Evidence
Strength of Recommendation
Clinical Algorithm(s) The following algorithms are provided in the original guideline document:
An algorithm titled "Management of acute atrial fibrillation/flutter after thoracic surgery" is also provided in Appendix C in the original guideline document. |
Evidence Supporting the Recommendations Type of Evidence Supporting the Recommendations The type of supporting evidence is identified and graded for selected recommendations (see the "Major Recommendations" field). Conclusions were based on prospective randomized clinical trials (RCTs) if available, to the exclusion of other data; if RCTs were not available, observational studies were admitted to consideration. If no such data were available for a given link in the problem formulation, expert opinion was used to estimate effect size. |
Benefits/Harms of Implementing the Guideline Recommendations Potential Benefits It is hoped that standardization of care will result in improved patient outcomes, shorter length of hospital stay, lower readmission rates, and overall cost savings for the system. Potential Harms
Refer to Table 4 and Appendices A and B in the original guideline document for more information on specific drugs. |
Major Recommendations Note from the University of Michigan Health System (UMHS) and the National Guideline Clearinghouse (NGC): The following guidance was current as of May 2014. Because UMHS occasionally releases minor revisions to its guidance based on new information, users may wish to consult the original guideline document Note from NGC: The following key points summarize the content of the guideline. Refer to the full text of the original guideline document for detailed information on each of the screening procedures. The strength of recommendation (I-III) and levels of evidence (A-D) are defined at the end of the "Major Recommendations" field. Key Points Clinical Presentation Patients presenting with palpitations, irregular pulse, chest pain, dyspnea, fatigue, lightheadedness, syncope, cardio-embolic disease and new or recurrent heart failure should be evaluated for atrial fibrillation/atrial flutter (AF/AFL). While AF may be asymptomatic and found incidentally, AFL is usually highly symptomatic. Diagnosis Electrocardiogram (ECG) is essential in the diagnosis of AF/AFL. The initial evaluation is summarized in Table 1 in the original guideline document and should include:
Treatment Initial treatment of AF/AFL depends on hemodynamic stability. Unstable AF/AFL (refer to Figure 1 in the original guideline document):
Stable AF/AFL (refer to Figure 2 in the original guideline document):
Definitions: Levels of Evidence
Strength of Recommendation
Clinical Algorithm(s) The following algorithms are provided in the original guideline document:
An algorithm titled "Management of acute atrial fibrillation/flutter after thoracic surgery" is also provided in Appendix C in the original guideline document. |
Evidence Supporting the Recommendations Type of Evidence Supporting the Recommendations The type of supporting evidence is identified and graded for selected recommendations (see the "Major Recommendations" field). Conclusions were based on prospective randomized clinical trials (RCTs) if available, to the exclusion of other data; if RCTs were not available, observational studies were admitted to consideration. If no such data were available for a given link in the problem formulation, expert opinion was used to estimate effect size. |
Benefits/Harms of Implementing the Guideline Recommendations Potential Benefits It is hoped that standardization of care will result in improved patient outcomes, shorter length of hospital stay, lower readmission rates, and overall cost savings for the system. Potential Harms
Refer to Table 4 and Appendices A and B in the original guideline document for more information on specific drugs. |
OBJECTIVE: To provide an evidence-based blue print for the acute care of patients with atrial fibrillation (AF) and atrial flutter (AFL) at the University of Michigan Health System and to assure consistent care delivery for patients with AF across the inpatient services.
Guidelines are copyright © 2014 University of Michigan Health System. All rights reserved. The summary is provided by the Agency for Healthcare Research and Quality.
Summary of evidence-based guideline: complementary and alternative medicine in multiple sclerosis. Report of the Guideline Development Subcommittee of the American Academy of Neurology
Cannabinoids
Cannabinoid Practice Recommendations
Clinicians might offer oral cannabis extract (OCE) to patients with multiple sclerosis (MS) to reduce patient-reported symptoms of spasticity and pain (excluding central neuropathic pain) (Level A) and might counsel patients that this symptomatic benefit is possibly maintained for 1 year (Level C), although OCE is probably ineffective for improving objective spasticity measures (short-term) or tremor (Level B).
Clinicians might offer tetrahydrocannabinol (THC) to patients with MS to reduce patient-reported symptoms of spasticity and pain (excluding central neuropathic pain) (Level B). Clinicians might counsel patients that this symptomatic benefit is possibly maintained for 1 year (Level C), although THC is probably ineffective for improving objective spasticity measures (short-term) or tremor (Level B).
Clinicians might offer Sativex oromucosal cannabinoid spray (nabiximols), where available, to reduce symptoms of spasticity, pain, or urinary frequency, although it is probably ineffective for improving objective spasticity measures or number of urinary incontinence episodes (Level B).
Clinicians might choose not to offer Sativex oromucosal cannabinoid spray to reduce MS-related tremor (Level C).
Data are inadequate to support or refute use of the following in MS (Level U):
- OCE/THC for bladder urge incontinence and overall symptoms
- Synthetic THC (Marinol) for central neuropathic pain
- Sativex oromucosal cannabinoid spray for overall bladder symptoms, anxiety symptoms/sleep problems, cognitive symptoms, quality of life (QOL), and fatigue
- Smoked cannabis for spasticity, pain, balance/posture, and cognition
Data are inadequate to determine the abuse potential or effect on psychopathologic symptoms of Sativex cannabinoid spray (Level U).
Clinical Context
The cannabinoid studies have limitations that physicians and patients must be aware of. Most studies were of short duration (6 to 15 weeks). Another limitation was the potential for central side effects to unmask patients to treatment assignment — a concern with regard to all masked trials involving treatments with prominent side effects. It is also important to recognize that the Ashworth scale used for objective measurement may be insensitive to spasticity changes. These factors may contribute to the discordant effects of cannabinoids on subjective and objective spasticity measures.
Ginkgo Biloba (GB)
GB Practice Recommendations
Clinicians might counsel patients with MS that GB is established as ineffective for improving cognitive function (Level A).
Clinicians might counsel patients with MS that GB is possibly effective for reducing fatigue (Level C).
Clinical Context
GB and other supplements are not U.S. Food and Drug Administration (FDA) regulated. Their quality control may play a role in their effectiveness and adverse effect (AE) risk. Moreover, interactions of supplements with other medications, especially disease-modifying therapies for MS, are a clinical concern.
Low-Fat Diet with Omega-3 Fatty Acid Supplementation (Omega-3)
Omega-3 Practice Recommendation
Clinicians might counsel patients that a low-fat diet with fish oil supplementation is probably ineffective for reducing relapses, disability, or magnetic resonance imaging (MRI) lesions, or for improving fatigue or QOL in MS (Level B).
Lofepramine
Lofepramine Practice Recommendation
Clinicians might counsel patients with MS that lofepramine plus L-phenylalanine with vitamin B12 (Cari Loder regimen) is possibly ineffective for treating disability, symptoms, depression, or fatigue (Level C).
Reflexology
Reflexology Practice Recommendation
Clinicians might counsel patients with MS that reflexology is possibly effective for reducing paresthesia (Level C).
Bee Venom
Bee Venom Practice Recommendation
Clinicians might counsel patients with MS that bee sting therapy is possibly ineffective for reducing relapses, disability, fatigue, total MRI lesion burden, new gadolinium-enhancing lesion volume, or health-related quality of life (HRQOL) (Level C).
Clinical Context
Bee stings can be associated with anaphylactic reaction and possible death.
Magnetic Therapy
Magnetic Therapy Practice Recommendation
Clinicians might counsel patients with MS that magnetic therapy is probably effective for reducing fatigue (Level B) and probably ineffective for reducing depression (Level B).
Other CAM Therapies Practice Recommendation
Clinicians should counsel patients with MS that the safety and efficacy of other reviewed CAM, or the interaction of CAM with disease-modifying therapies for MS, are unknown (Level U).
Definitions:
Classification of Evidence for Therapeutic Interventions
Class I: A randomized, controlled clinical trial of the intervention of interest with masked or objective outcome assessment, in a representative population. Relevant baseline characteristics are presented and substantially equivalent among treatment groups or there is appropriate statistical adjustment for differences.
The following are also required:
- Concealed allocation
- Primary outcome(s) clearly defined
- Exclusion/inclusion criteria clearly defined
- Adequate accounting for drop-outs (with at least 80% of enrolled subjects completing the study) and cross-overs with numbers sufficiently low to have minimal potential for bias.
- For noninferiority or equivalence trials claiming to prove efficacy for one or both drugs, the following are also required*:
- The authors explicitly state the clinically meaningful difference to be excluded by defining the threshold for equivalence or noninferiority.
- The standard treatment used in the study is substantially similar to that used in previous studies establishing efficacy of the standard treatment (e.g., for a drug, the mode of administration, dose and dosage adjustments are similar to those previously shown to be effective).
- The inclusion and exclusion criteria for patient selection and the outcomes of patients on the standard treatment are comparable to those of previous studies establishing efficacy of the standard treatment.
- The interpretation of the results of the study is based upon a per protocol analysis that takes into account dropouts or crossovers.
Class II: A randomized controlled clinical trial of the intervention of interest in a representative population with masked or objective outcome assessment that lacks one criteria a-e above or a prospective matched cohort study with masked or objective outcome assessment in a representative population that meets b-e above. Relevant baseline characteristics are presented and substantially equivalent among treatment groups or there is appropriate statistical adjustment for differences.
Class III: All other controlled trials (including well-defined natural history controls or patients serving as own controls) in a representative population, where outcome is independently assessed, or independently derived by objective outcome measurement.**
Class IV: Studies not meeting Class I, II or III criteria including consensus or expert opinion.
*Note that numbers 1-3 in Class Ie are required for Class II in equivalence trials. If any one of the three is missing, the class is automatically downgraded to Class III.
**Objective outcome measurement: an outcome measure that is unlikely to be affected by an observer's (patient, treating physician, investigator) expectation or bias (e.g., blood tests, administrative outcome data).
Classification of Recommendations
Level A = Established as effective, ineffective, or harmful (or established as useful/predictive or not useful/predictive) for the given condition in the specified population. (Level A rating requires at least two consistent Class I studies.)*
Level B = Probably effective, ineffective, or harmful (or probably useful/predictive or not useful/predictive) for the given condition in the specified population. (Level B rating requires at least one Class I study or at least two consistent Class II studies.)
Level C = Possibly effective, ineffective, or harmful (or possibly useful/predictive or not useful/predictive) for the given condition in the specified population. (Level C rating requires at least one Class II study or two consistent Class III studies.)
Level U = Data inadequate or conflicting; given current knowledge, treatment (test, predictor) is unproven.
*In exceptional cases, one convincing Class I study may suffice for an "A" recommendation if 1) all criteria are met, 2) the magnitude of effect is large (relative rate improved outcome >5 and the lower limit of the confidence interval is >2).
Cannabinoids
Cannabinoid Practice Recommendations
Clinicians might offer oral cannabis extract (OCE) to patients with multiple sclerosis (MS) to reduce patient-reported symptoms of spasticity and pain (excluding central neuropathic pain) (Level A) and might counsel patients that this symptomatic benefit is possibly maintained for 1 year (Level C), although OCE is probably ineffective for improving objective spasticity measures (short-term) or tremor (Level B).
Clinicians might offer tetrahydrocannabinol (THC) to patients with MS to reduce patient-reported symptoms of spasticity and pain (excluding central neuropathic pain) (Level B). Clinicians might counsel patients that this symptomatic benefit is possibly maintained for 1 year (Level C), although THC is probably ineffective for improving objective spasticity measures (short-term) or tremor (Level B).
Clinicians might offer Sativex oromucosal cannabinoid spray (nabiximols), where available, to reduce symptoms of spasticity, pain, or urinary frequency, although it is probably ineffective for improving objective spasticity measures or number of urinary incontinence episodes (Level B).
Clinicians might choose not to offer Sativex oromucosal cannabinoid spray to reduce MS-related tremor (Level C).
Data are inadequate to support or refute use of the following in MS (Level U):
- OCE/THC for bladder urge incontinence and overall symptoms
- Synthetic THC (Marinol) for central neuropathic pain
- Sativex oromucosal cannabinoid spray for overall bladder symptoms, anxiety symptoms/sleep problems, cognitive symptoms, quality of life (QOL), and fatigue
- Smoked cannabis for spasticity, pain, balance/posture, and cognition
Data are inadequate to determine the abuse potential or effect on psychopathologic symptoms of Sativex cannabinoid spray (Level U).
Clinical Context
The cannabinoid studies have limitations that physicians and patients must be aware of. Most studies were of short duration (6 to 15 weeks). Another limitation was the potential for central side effects to unmask patients to treatment assignment — a concern with regard to all masked trials involving treatments with prominent side effects. It is also important to recognize that the Ashworth scale used for objective measurement may be insensitive to spasticity changes. These factors may contribute to the discordant effects of cannabinoids on subjective and objective spasticity measures.
Ginkgo Biloba (GB)
GB Practice Recommendations
Clinicians might counsel patients with MS that GB is established as ineffective for improving cognitive function (Level A).
Clinicians might counsel patients with MS that GB is possibly effective for reducing fatigue (Level C).
Clinical Context
GB and other supplements are not U.S. Food and Drug Administration (FDA) regulated. Their quality control may play a role in their effectiveness and adverse effect (AE) risk. Moreover, interactions of supplements with other medications, especially disease-modifying therapies for MS, are a clinical concern.
Low-Fat Diet with Omega-3 Fatty Acid Supplementation (Omega-3)
Omega-3 Practice Recommendation
Clinicians might counsel patients that a low-fat diet with fish oil supplementation is probably ineffective for reducing relapses, disability, or magnetic resonance imaging (MRI) lesions, or for improving fatigue or QOL in MS (Level B).
Lofepramine
Lofepramine Practice Recommendation
Clinicians might counsel patients with MS that lofepramine plus L-phenylalanine with vitamin B12 (Cari Loder regimen) is possibly ineffective for treating disability, symptoms, depression, or fatigue (Level C).
Reflexology
Reflexology Practice Recommendation
Clinicians might counsel patients with MS that reflexology is possibly effective for reducing paresthesia (Level C).
Bee Venom
Bee Venom Practice Recommendation
Clinicians might counsel patients with MS that bee sting therapy is possibly ineffective for reducing relapses, disability, fatigue, total MRI lesion burden, new gadolinium-enhancing lesion volume, or health-related quality of life (HRQOL) (Level C).
Clinical Context
Bee stings can be associated with anaphylactic reaction and possible death.
Magnetic Therapy
Magnetic Therapy Practice Recommendation
Clinicians might counsel patients with MS that magnetic therapy is probably effective for reducing fatigue (Level B) and probably ineffective for reducing depression (Level B).
Other CAM Therapies Practice Recommendation
Clinicians should counsel patients with MS that the safety and efficacy of other reviewed CAM, or the interaction of CAM with disease-modifying therapies for MS, are unknown (Level U).
Definitions:
Classification of Evidence for Therapeutic Interventions
Class I: A randomized, controlled clinical trial of the intervention of interest with masked or objective outcome assessment, in a representative population. Relevant baseline characteristics are presented and substantially equivalent among treatment groups or there is appropriate statistical adjustment for differences.
The following are also required:
- Concealed allocation
- Primary outcome(s) clearly defined
- Exclusion/inclusion criteria clearly defined
- Adequate accounting for drop-outs (with at least 80% of enrolled subjects completing the study) and cross-overs with numbers sufficiently low to have minimal potential for bias.
- For noninferiority or equivalence trials claiming to prove efficacy for one or both drugs, the following are also required*:
- The authors explicitly state the clinically meaningful difference to be excluded by defining the threshold for equivalence or noninferiority.
- The standard treatment used in the study is substantially similar to that used in previous studies establishing efficacy of the standard treatment (e.g., for a drug, the mode of administration, dose and dosage adjustments are similar to those previously shown to be effective).
- The inclusion and exclusion criteria for patient selection and the outcomes of patients on the standard treatment are comparable to those of previous studies establishing efficacy of the standard treatment.
- The interpretation of the results of the study is based upon a per protocol analysis that takes into account dropouts or crossovers.
Class II: A randomized controlled clinical trial of the intervention of interest in a representative population with masked or objective outcome assessment that lacks one criteria a-e above or a prospective matched cohort study with masked or objective outcome assessment in a representative population that meets b-e above. Relevant baseline characteristics are presented and substantially equivalent among treatment groups or there is appropriate statistical adjustment for differences.
Class III: All other controlled trials (including well-defined natural history controls or patients serving as own controls) in a representative population, where outcome is independently assessed, or independently derived by objective outcome measurement.**
Class IV: Studies not meeting Class I, II or III criteria including consensus or expert opinion.
*Note that numbers 1-3 in Class Ie are required for Class II in equivalence trials. If any one of the three is missing, the class is automatically downgraded to Class III.
**Objective outcome measurement: an outcome measure that is unlikely to be affected by an observer's (patient, treating physician, investigator) expectation or bias (e.g., blood tests, administrative outcome data).
Classification of Recommendations
Level A = Established as effective, ineffective, or harmful (or established as useful/predictive or not useful/predictive) for the given condition in the specified population. (Level A rating requires at least two consistent Class I studies.)*
Level B = Probably effective, ineffective, or harmful (or probably useful/predictive or not useful/predictive) for the given condition in the specified population. (Level B rating requires at least one Class I study or at least two consistent Class II studies.)
Level C = Possibly effective, ineffective, or harmful (or possibly useful/predictive or not useful/predictive) for the given condition in the specified population. (Level C rating requires at least one Class II study or two consistent Class III studies.)
Level U = Data inadequate or conflicting; given current knowledge, treatment (test, predictor) is unproven.
*In exceptional cases, one convincing Class I study may suffice for an "A" recommendation if 1) all criteria are met, 2) the magnitude of effect is large (relative rate improved outcome >5 and the lower limit of the confidence interval is >2).
Cannabinoids
Cannabinoid Practice Recommendations
Clinicians might offer oral cannabis extract (OCE) to patients with multiple sclerosis (MS) to reduce patient-reported symptoms of spasticity and pain (excluding central neuropathic pain) (Level A) and might counsel patients that this symptomatic benefit is possibly maintained for 1 year (Level C), although OCE is probably ineffective for improving objective spasticity measures (short-term) or tremor (Level B).
Clinicians might offer tetrahydrocannabinol (THC) to patients with MS to reduce patient-reported symptoms of spasticity and pain (excluding central neuropathic pain) (Level B). Clinicians might counsel patients that this symptomatic benefit is possibly maintained for 1 year (Level C), although THC is probably ineffective for improving objective spasticity measures (short-term) or tremor (Level B).
Clinicians might offer Sativex oromucosal cannabinoid spray (nabiximols), where available, to reduce symptoms of spasticity, pain, or urinary frequency, although it is probably ineffective for improving objective spasticity measures or number of urinary incontinence episodes (Level B).
Clinicians might choose not to offer Sativex oromucosal cannabinoid spray to reduce MS-related tremor (Level C).
Data are inadequate to support or refute use of the following in MS (Level U):
- OCE/THC for bladder urge incontinence and overall symptoms
- Synthetic THC (Marinol) for central neuropathic pain
- Sativex oromucosal cannabinoid spray for overall bladder symptoms, anxiety symptoms/sleep problems, cognitive symptoms, quality of life (QOL), and fatigue
- Smoked cannabis for spasticity, pain, balance/posture, and cognition
Data are inadequate to determine the abuse potential or effect on psychopathologic symptoms of Sativex cannabinoid spray (Level U).
Clinical Context
The cannabinoid studies have limitations that physicians and patients must be aware of. Most studies were of short duration (6 to 15 weeks). Another limitation was the potential for central side effects to unmask patients to treatment assignment — a concern with regard to all masked trials involving treatments with prominent side effects. It is also important to recognize that the Ashworth scale used for objective measurement may be insensitive to spasticity changes. These factors may contribute to the discordant effects of cannabinoids on subjective and objective spasticity measures.
Ginkgo Biloba (GB)
GB Practice Recommendations
Clinicians might counsel patients with MS that GB is established as ineffective for improving cognitive function (Level A).
Clinicians might counsel patients with MS that GB is possibly effective for reducing fatigue (Level C).
Clinical Context
GB and other supplements are not U.S. Food and Drug Administration (FDA) regulated. Their quality control may play a role in their effectiveness and adverse effect (AE) risk. Moreover, interactions of supplements with other medications, especially disease-modifying therapies for MS, are a clinical concern.
Low-Fat Diet with Omega-3 Fatty Acid Supplementation (Omega-3)
Omega-3 Practice Recommendation
Clinicians might counsel patients that a low-fat diet with fish oil supplementation is probably ineffective for reducing relapses, disability, or magnetic resonance imaging (MRI) lesions, or for improving fatigue or QOL in MS (Level B).
Lofepramine
Lofepramine Practice Recommendation
Clinicians might counsel patients with MS that lofepramine plus L-phenylalanine with vitamin B12 (Cari Loder regimen) is possibly ineffective for treating disability, symptoms, depression, or fatigue (Level C).
Reflexology
Reflexology Practice Recommendation
Clinicians might counsel patients with MS that reflexology is possibly effective for reducing paresthesia (Level C).
Bee Venom
Bee Venom Practice Recommendation
Clinicians might counsel patients with MS that bee sting therapy is possibly ineffective for reducing relapses, disability, fatigue, total MRI lesion burden, new gadolinium-enhancing lesion volume, or health-related quality of life (HRQOL) (Level C).
Clinical Context
Bee stings can be associated with anaphylactic reaction and possible death.
Magnetic Therapy
Magnetic Therapy Practice Recommendation
Clinicians might counsel patients with MS that magnetic therapy is probably effective for reducing fatigue (Level B) and probably ineffective for reducing depression (Level B).
Other CAM Therapies Practice Recommendation
Clinicians should counsel patients with MS that the safety and efficacy of other reviewed CAM, or the interaction of CAM with disease-modifying therapies for MS, are unknown (Level U).
Definitions:
Classification of Evidence for Therapeutic Interventions
Class I: A randomized, controlled clinical trial of the intervention of interest with masked or objective outcome assessment, in a representative population. Relevant baseline characteristics are presented and substantially equivalent among treatment groups or there is appropriate statistical adjustment for differences.
The following are also required:
- Concealed allocation
- Primary outcome(s) clearly defined
- Exclusion/inclusion criteria clearly defined
- Adequate accounting for drop-outs (with at least 80% of enrolled subjects completing the study) and cross-overs with numbers sufficiently low to have minimal potential for bias.
- For noninferiority or equivalence trials claiming to prove efficacy for one or both drugs, the following are also required*:
- The authors explicitly state the clinically meaningful difference to be excluded by defining the threshold for equivalence or noninferiority.
- The standard treatment used in the study is substantially similar to that used in previous studies establishing efficacy of the standard treatment (e.g., for a drug, the mode of administration, dose and dosage adjustments are similar to those previously shown to be effective).
- The inclusion and exclusion criteria for patient selection and the outcomes of patients on the standard treatment are comparable to those of previous studies establishing efficacy of the standard treatment.
- The interpretation of the results of the study is based upon a per protocol analysis that takes into account dropouts or crossovers.
Class II: A randomized controlled clinical trial of the intervention of interest in a representative population with masked or objective outcome assessment that lacks one criteria a-e above or a prospective matched cohort study with masked or objective outcome assessment in a representative population that meets b-e above. Relevant baseline characteristics are presented and substantially equivalent among treatment groups or there is appropriate statistical adjustment for differences.
Class III: All other controlled trials (including well-defined natural history controls or patients serving as own controls) in a representative population, where outcome is independently assessed, or independently derived by objective outcome measurement.**
Class IV: Studies not meeting Class I, II or III criteria including consensus or expert opinion.
*Note that numbers 1-3 in Class Ie are required for Class II in equivalence trials. If any one of the three is missing, the class is automatically downgraded to Class III.
**Objective outcome measurement: an outcome measure that is unlikely to be affected by an observer's (patient, treating physician, investigator) expectation or bias (e.g., blood tests, administrative outcome data).
Classification of Recommendations
Level A = Established as effective, ineffective, or harmful (or established as useful/predictive or not useful/predictive) for the given condition in the specified population. (Level A rating requires at least two consistent Class I studies.)*
Level B = Probably effective, ineffective, or harmful (or probably useful/predictive or not useful/predictive) for the given condition in the specified population. (Level B rating requires at least one Class I study or at least two consistent Class II studies.)
Level C = Possibly effective, ineffective, or harmful (or possibly useful/predictive or not useful/predictive) for the given condition in the specified population. (Level C rating requires at least one Class II study or two consistent Class III studies.)
Level U = Data inadequate or conflicting; given current knowledge, treatment (test, predictor) is unproven.
*In exceptional cases, one convincing Class I study may suffice for an "A" recommendation if 1) all criteria are met, 2) the magnitude of effect is large (relative rate improved outcome >5 and the lower limit of the confidence interval is >2).
OBJECTIVE:
To develop evidence-based recommendations for complementary and alternative medicine (CAM) in multiple sclerosis (MS).
METHODS:
We searched the literature (1970-March 2011; March 2011-September 2013 MEDLINE search), classified articles, and linked recommendations to evidence.
Guidelines are copyright © 2014 American Academy of Neurology. All rights reserved. The summary is provided by the Agency for Healthcare Research and Quality.
Clinical policy: critical issues in the evaluation and management of adult patients presenting to the emergency department with seizures
Definitions for the strength of evidence (Class I-III) and strength of recommendations (Level A-C) are provided at the end of the "Major Recommendations" field.
- In patients with a first generalized convulsive seizure who have returned to their baseline clinical status, should antiepileptic therapy be initiated in the emergency department (ED) to prevent additional seizures?
Patient Management Recommendations
Level A recommendations. None specified.
Level B recommendations. None specified.
Level C recommendations.
- Emergency physicians need not initiate antiepileptic medication* in the ED for patients who have had a first provoked seizure. Precipitating medical conditions should be identified and treated.
- Emergency physicians need not initiate antiepileptic medication* in the ED for patients who have had a first unprovoked seizure without evidence of brain disease or injury.
- Emergency physicians may initiate antiepileptic medication* in the ED, or defer in coordination with other providers, for patients who experienced a first unprovoked seizure with a remote history of brain disease or injury.
*Antiepileptic medication in this document refers to medications prescribed for seizure prevention.
- In patients with a first unprovoked seizure who have returned to their baseline clinical status in the ED, should the patient be admitted to the hospital to prevent adverse events?
Patient Management Recommendations
Level A recommendations. None specified.
Level B recommendations. None specified.
Level C recommendations. Emergency physicians need not admit patients with a first unprovoked seizure who have returned to their clinical baseline in the ED.
- In patients with a known seizure disorder in which resuming their antiepileptic medication in the ED is deemed appropriate, does the route of administration impact recurrence of seizures?
Patient Management Recommendations
Level A recommendations. None specified.
Level B recommendations. None specified.
Level C recommendations. When resuming antiepileptic medication in the ED is deemed appropriate, the emergency physician may administer intravenous (IV) or oral medication at their discretion.
- In ED patients with generalized convulsive status epilepticus who continue to have seizures despite receiving optimal dosing of a benzodiazepine, which agent or agents should be administered next to terminate seizures?
Patient Management Recommendations
Level A recommendations. Emergency physicians should administer an additional antiepileptic medication in ED patients with refractory status epilepticus who have failed treatment with benzodiazepines.
Level B recommendations. Emergency physicians may administer IV phenytoin, fosphenytoin, or valproate in ED patients with refractory status epilepticus who have failed treatment with benzodiazepines.
Level C recommendations. Emergency physicians may administer IV levetiracetam, propofol, or barbiturates in ED patients with refractory status epilepticus who have failed treatment with benzodiazepines.
Definitions:
Strength of Evidence
Literature Classification Schema*
Design/Class Therapy† Diagnosis‡ Prognosis§ 1 Randomized, controlled trial or meta-analysis of randomized trials Prospective cohort using a criterion standard or meta-analysis of prospective studies Population prospective cohort or meta-analysis of prospective studies 2 Nonrandomized trial Retrospective observational Retrospective cohort
Case control3 Case series
Case report
Other (e.g., consensus, review)Case series
Case report
Other (e.g., consensus, review)Case series
Case report
Other (e.g., consensus, review)*Some designs (e.g., surveys) will not fit this schema and should be assessed individually.
†Objective is to measure therapeutic efficacy comparing interventions.
‡Objective is to determine the sensitivity and specificity of diagnostic tests.
§Objective is to predict outcome including mortality and morbidity.
Approach to Downgrading Strength of Evidence*
Design/Class Downgrading 1 2 3 None I II III 1 level II III X 2 levels III X X Fatally flawed X X X *See the "Description of Methods Used to Analyze the Evidence" field for more information.
Strength of recommendations regarding each critical question were made by subcommittee members using results from strength of evidence grading, expert opinion, and consensus among subcommittee members according to the following guidelines:
Strength of Recommendations
Level A recommendations. Generally accepted principles for patient care that reflect a high degree of clinical certainty (i.e., based on evidence from 1 or more Class of Evidence I or multiple Class of Evidence II studies).
Level B recommendations. Recommendations for patient care that may identify a particular strategy or range of strategies that reflect moderate clinical certainty (i.e., based on evidence from 1 or more Class of Evidence II studies or strong consensus of Class of Evidence III studies).
Level C recommendations. Recommendations for patient care that are based on evidence from Class of Evidence III studies or, in the absence of any adequate published literature, based on expert consensus. In instances where consensus recommendations are made, "consensus" is placed in parentheses at the end of the recommendation.
There are certain circumstances in which the recommendations stemming from a body of evidence should not be rated as highly as the individual studies on which they are based. Factors such as heterogeneity of results, uncertainty about effect magnitude and consequences, and publication bias, among others, might lead to such a downgrading of recommendations.
Definitions for the strength of evidence (Class I-III) and strength of recommendations (Level A-C) are provided at the end of the "Major Recommendations" field.
- In patients with a first generalized convulsive seizure who have returned to their baseline clinical status, should antiepileptic therapy be initiated in the emergency department (ED) to prevent additional seizures?
Patient Management Recommendations
Level A recommendations. None specified.
Level B recommendations. None specified.
Level C recommendations.
- Emergency physicians need not initiate antiepileptic medication* in the ED for patients who have had a first provoked seizure. Precipitating medical conditions should be identified and treated.
- Emergency physicians need not initiate antiepileptic medication* in the ED for patients who have had a first unprovoked seizure without evidence of brain disease or injury.
- Emergency physicians may initiate antiepileptic medication* in the ED, or defer in coordination with other providers, for patients who experienced a first unprovoked seizure with a remote history of brain disease or injury.
*Antiepileptic medication in this document refers to medications prescribed for seizure prevention.
- In patients with a first unprovoked seizure who have returned to their baseline clinical status in the ED, should the patient be admitted to the hospital to prevent adverse events?
Patient Management Recommendations
Level A recommendations. None specified.
Level B recommendations. None specified.
Level C recommendations. Emergency physicians need not admit patients with a first unprovoked seizure who have returned to their clinical baseline in the ED.
- In patients with a known seizure disorder in which resuming their antiepileptic medication in the ED is deemed appropriate, does the route of administration impact recurrence of seizures?
Patient Management Recommendations
Level A recommendations. None specified.
Level B recommendations. None specified.
Level C recommendations. When resuming antiepileptic medication in the ED is deemed appropriate, the emergency physician may administer intravenous (IV) or oral medication at their discretion.
- In ED patients with generalized convulsive status epilepticus who continue to have seizures despite receiving optimal dosing of a benzodiazepine, which agent or agents should be administered next to terminate seizures?
Patient Management Recommendations
Level A recommendations. Emergency physicians should administer an additional antiepileptic medication in ED patients with refractory status epilepticus who have failed treatment with benzodiazepines.
Level B recommendations. Emergency physicians may administer IV phenytoin, fosphenytoin, or valproate in ED patients with refractory status epilepticus who have failed treatment with benzodiazepines.
Level C recommendations. Emergency physicians may administer IV levetiracetam, propofol, or barbiturates in ED patients with refractory status epilepticus who have failed treatment with benzodiazepines.
Definitions:
Strength of Evidence
Literature Classification Schema*
Design/Class Therapy† Diagnosis‡ Prognosis§ 1 Randomized, controlled trial or meta-analysis of randomized trials Prospective cohort using a criterion standard or meta-analysis of prospective studies Population prospective cohort or meta-analysis of prospective studies 2 Nonrandomized trial Retrospective observational Retrospective cohort
Case control3 Case series
Case report
Other (e.g., consensus, review)Case series
Case report
Other (e.g., consensus, review)Case series
Case report
Other (e.g., consensus, review)*Some designs (e.g., surveys) will not fit this schema and should be assessed individually.
†Objective is to measure therapeutic efficacy comparing interventions.
‡Objective is to determine the sensitivity and specificity of diagnostic tests.
§Objective is to predict outcome including mortality and morbidity.
Approach to Downgrading Strength of Evidence*
Design/Class Downgrading 1 2 3 None I II III 1 level II III X 2 levels III X X Fatally flawed X X X *See the "Description of Methods Used to Analyze the Evidence" field for more information.
Strength of recommendations regarding each critical question were made by subcommittee members using results from strength of evidence grading, expert opinion, and consensus among subcommittee members according to the following guidelines:
Strength of Recommendations
Level A recommendations. Generally accepted principles for patient care that reflect a high degree of clinical certainty (i.e., based on evidence from 1 or more Class of Evidence I or multiple Class of Evidence II studies).
Level B recommendations. Recommendations for patient care that may identify a particular strategy or range of strategies that reflect moderate clinical certainty (i.e., based on evidence from 1 or more Class of Evidence II studies or strong consensus of Class of Evidence III studies).
Level C recommendations. Recommendations for patient care that are based on evidence from Class of Evidence III studies or, in the absence of any adequate published literature, based on expert consensus. In instances where consensus recommendations are made, "consensus" is placed in parentheses at the end of the recommendation.
There are certain circumstances in which the recommendations stemming from a body of evidence should not be rated as highly as the individual studies on which they are based. Factors such as heterogeneity of results, uncertainty about effect magnitude and consequences, and publication bias, among others, might lead to such a downgrading of recommendations.
Definitions for the strength of evidence (Class I-III) and strength of recommendations (Level A-C) are provided at the end of the "Major Recommendations" field.
- In patients with a first generalized convulsive seizure who have returned to their baseline clinical status, should antiepileptic therapy be initiated in the emergency department (ED) to prevent additional seizures?
Patient Management Recommendations
Level A recommendations. None specified.
Level B recommendations. None specified.
Level C recommendations.
- Emergency physicians need not initiate antiepileptic medication* in the ED for patients who have had a first provoked seizure. Precipitating medical conditions should be identified and treated.
- Emergency physicians need not initiate antiepileptic medication* in the ED for patients who have had a first unprovoked seizure without evidence of brain disease or injury.
- Emergency physicians may initiate antiepileptic medication* in the ED, or defer in coordination with other providers, for patients who experienced a first unprovoked seizure with a remote history of brain disease or injury.
*Antiepileptic medication in this document refers to medications prescribed for seizure prevention.
- In patients with a first unprovoked seizure who have returned to their baseline clinical status in the ED, should the patient be admitted to the hospital to prevent adverse events?
Patient Management Recommendations
Level A recommendations. None specified.
Level B recommendations. None specified.
Level C recommendations. Emergency physicians need not admit patients with a first unprovoked seizure who have returned to their clinical baseline in the ED.
- In patients with a known seizure disorder in which resuming their antiepileptic medication in the ED is deemed appropriate, does the route of administration impact recurrence of seizures?
Patient Management Recommendations
Level A recommendations. None specified.
Level B recommendations. None specified.
Level C recommendations. When resuming antiepileptic medication in the ED is deemed appropriate, the emergency physician may administer intravenous (IV) or oral medication at their discretion.
- In ED patients with generalized convulsive status epilepticus who continue to have seizures despite receiving optimal dosing of a benzodiazepine, which agent or agents should be administered next to terminate seizures?
Patient Management Recommendations
Level A recommendations. Emergency physicians should administer an additional antiepileptic medication in ED patients with refractory status epilepticus who have failed treatment with benzodiazepines.
Level B recommendations. Emergency physicians may administer IV phenytoin, fosphenytoin, or valproate in ED patients with refractory status epilepticus who have failed treatment with benzodiazepines.
Level C recommendations. Emergency physicians may administer IV levetiracetam, propofol, or barbiturates in ED patients with refractory status epilepticus who have failed treatment with benzodiazepines.
Definitions:
Strength of Evidence
Literature Classification Schema*
Design/Class Therapy† Diagnosis‡ Prognosis§ 1 Randomized, controlled trial or meta-analysis of randomized trials Prospective cohort using a criterion standard or meta-analysis of prospective studies Population prospective cohort or meta-analysis of prospective studies 2 Nonrandomized trial Retrospective observational Retrospective cohort
Case control3 Case series
Case report
Other (e.g., consensus, review)Case series
Case report
Other (e.g., consensus, review)Case series
Case report
Other (e.g., consensus, review)*Some designs (e.g., surveys) will not fit this schema and should be assessed individually.
†Objective is to measure therapeutic efficacy comparing interventions.
‡Objective is to determine the sensitivity and specificity of diagnostic tests.
§Objective is to predict outcome including mortality and morbidity.
Approach to Downgrading Strength of Evidence*
Design/Class Downgrading 1 2 3 None I II III 1 level II III X 2 levels III X X Fatally flawed X X X *See the "Description of Methods Used to Analyze the Evidence" field for more information.
Strength of recommendations regarding each critical question were made by subcommittee members using results from strength of evidence grading, expert opinion, and consensus among subcommittee members according to the following guidelines:
Strength of Recommendations
Level A recommendations. Generally accepted principles for patient care that reflect a high degree of clinical certainty (i.e., based on evidence from 1 or more Class of Evidence I or multiple Class of Evidence II studies).
Level B recommendations. Recommendations for patient care that may identify a particular strategy or range of strategies that reflect moderate clinical certainty (i.e., based on evidence from 1 or more Class of Evidence II studies or strong consensus of Class of Evidence III studies).
Level C recommendations. Recommendations for patient care that are based on evidence from Class of Evidence III studies or, in the absence of any adequate published literature, based on expert consensus. In instances where consensus recommendations are made, "consensus" is placed in parentheses at the end of the recommendation.
There are certain circumstances in which the recommendations stemming from a body of evidence should not be rated as highly as the individual studies on which they are based. Factors such as heterogeneity of results, uncertainty about effect magnitude and consequences, and publication bias, among others, might lead to such a downgrading of recommendations.
This clinical policy from the American College of Emergency Physicians is the revision of a 2004 policy on critical issues in the evaluation and management of adult patients with seizures in the emergency department. A writing subcommittee reviewed the literature to derive evidence-based recommendations to help clinicians answer four critical questions. A literature search was performed, the evidence was graded, and recommendations were given based on the strength of the available data in the medical literature.
Guidelines are copyright © 2014 American College of Emergency Physicians. All rights reserved. The summary is provided by the Agency for Healthcare Research and Quality.
Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis
Note from the National Guideline Clearinghouse (NGC): This document is the first section in a series of four and covers methods for diagnosis and assessment of atopic dermatitis (AD). The second guideline in the series will address the management and treatment of AD with pharmacologic and nonpharmacologic topical modalities; the third section will cover phototherapy and systemic treatment options; and the fourth section will address the minimization of disease flares, educational interventions, and use of adjunctive approaches.
Features to Be Considered in the Diagnosis of Patients with AD
| Essential Features—Must be present:
*Patterns Include:
Important Features—Seen in most cases, adding support to the diagnosis:
Associated Features—These clinical associations help to suggest the diagnosis of AD but are too nonspecific to be used for defining or detecting AD for research and epidemiologic studies:
Exclusionary Conditions—It should be noted that a diagnosis of AD depends on excluding conditions, such as:
Adapted from Eichenfield LF, Hanifin JM, Luger TA, Stevens SR, Pride HB. Consensus conference on pediatric atopic dermatitis. J Am Acad Dermatol 2003;49:1088-95. Used with permission of the American Academy of Dermatology. |
Recommendation for the Diagnosis of AD
Patients with presumed AD should have their diagnosis based on the criteria summarized in the box above. On occasion, skin biopsy specimens or other tests (such as serum immunoglobulin E, potassium hydroxide preparation, patch testing, and/or genetic testing) may be helpful to rule out other or associated skin conditions.
Strength of Recommendations for the Diagnosis and Assessment of AD
| Recommendation | Strength of Recommendation | Level of Evidence | References |
|---|---|---|---|
| Diagnosis made using criteria in the box above | C | III | Mevorah et al., 1988; Gu et al., 2001; Lan et al., 2009; Diepgen, Sauerbrei, & Fartasch, 1996; De, Kanwar, & Handa, 2006; Loden, Andersson, & Lindberg, 1998; Samochocki & Dejewska, 2012; Samochocki, Paulochowska, & Zabielski, 2000; Chalmers et al., 2007; Firooz et al., 1999; Saeki et al., 2007; Firooz & Kashani, 2008; Hamada et al., 2005; Williams et al., 1994; Williams et al., 1996 |
| No specific biomarkers for diagnosis or severity assessment | B | II | Murat-Susic et al., 2006; Schulte-Herbruggen et al., 2007; Amon et al., 2000; Dhar et al., 2005; Gerdes, Kurrat, & Mrowietz, 2009; Aral et al, 2006; Di Lorenzo et al., 2003; El Mongy et al., 2008; Ezzat, Hasan, & Shaheen, 2011; Jahnz-Rozyk et al., 2005; Nakazato et al., 2008; Belloni Fortina et al., 2006; Gutgesell et al., 2002; Hirai et al., 1996; Hon et al., 2007; Horikawa et al., 2002; Kakinuma et al., 2003; La Grutta et al., 2005; Leung et al., 2003; Mostafa et al., 2008; Oflazoglu et al., "CD30 expression," 2008; Oflazoglu et al., "CD40 expression," 2008; Ott et al., 2010; Raap et al., 2006; Song et al., 2006; Wolkerstorfer et al., 1998 |
| Immunoglobulin E levels not routinely recommended | A | I | Schneider et al., 2013; Murat-Susic et al., 2006; Schulte-Herbruggen et al., 2007; Gerdes, Kurrat, & Mrowietz, 2009; Aral et al., 2006; Vakirlis et al., 2011; Wu et al., 2011 |
| Available disease severity scales not for routine clinical use | C | II | Schmitt, Langan, & Williams, 2007; Schram et al., 2012; Sprikkelman et al., 1997; Angelova-Fischer et al., 2005; Wolkerstorfer et al., 1999; Linnet & Jemec, 1999; Hon et al., 2006; Barbier et al., 2004; Charman, Venn, & Williams, 2002; Charman, Venn, & Williams, 2004; Charman et al., 1999; Cosickic et al., 2010; Emerson, Charman, & Williams, 2000; Hanifin et al., 2001; Holm et al., 2007; Oranje et al., 1997; Rullo et al., 2008 |
| Available quality of life severity scales not for routine clinical use | C | II | Chamlin et al., 2007; Augustin et al., 2004; Hon et al, 2006; Misery et al., 2007 |
| Should query itch, sleep, impact on daily activity, and disease persistence | C | III | Chamlin et al., 2005; Hon et al., 2008; Dawn et al., 2009; Lewis-Jones, 2006; Weisshaar et al., 2008; Ricci et al., 2007; Bender et al., 2008; Ben-Gashir, Seed, & Hay, 2002 |
| Awareness and discussion of common associations | C | I and II | Chamlin et al., 2005; Hon et al., 2008; Batlles-Garrido et al., 2010; Chawes et al., 2010; Sultesz et al., 2010; Kyllonen et al., 2006; Hwang et al., 2010; Hyvarinen et al., 2005; Eller et al., 2009; Horwitz, Hossain, & Yousef, 2009; Bashir, Dar, & Rao, 2010; Schmitt et al., "Psychiatric comorbidity," 2009; Schmitt et al., "Atopic eczema," 2009; Yaghmaie, Koudelka, & Simpson, 2013; Harding et al., 2008; Synnerstad et al., 2008; Vajdic et al., 2009; Kajbaf, Asar, & Alipoor, 2011; Vlaski et al., 2006 |
| Integrated, multidisciplinary approach to care | C | III | Boguniewicz et al., 2008; Ricci et al., 2009 |
Recommendations for the Use of Biomarkers in the Assessment of AD
- For patients with presumed AD, there are no specific biomarkers that can be recommended for diagnosis and/or assessment of disease severity.
- Monitoring of immunoglobulin E levels is not recommended for the routine assessment of disease severity.
Recommendations for Disease Severity and Clinical Outcomes Assessment
- For the general management of patients with AD, available disease severity measurement scales are not recommended for routine clinical practice, because they were not usually designed for this purpose.
- For the general management of patients with AD, available patient quality of life measurement scales are not recommended for routine clinical practice.
- It is recommended that clinicians ask general questions about itch, sleep, impact on daily activity, and persistence of disease, and currently available scales be used mainly when practical.
Recommendations for the Assessment of Clinical Associations of AD
- Physicians should be aware of and assess for conditions associated with AD, such as rhinitis/rhinoconjunctivitis, asthma, food allergy, sleep disturbance, depression, and other neuropsychiatric conditions, and it is recommended that physicians discuss them with the patient as part of the treatment/management plan, when appropriate.
- An integrated, multidisciplinary approach to care may be valuable and is suggested for AD patients who present with common associations.
Definitions:
Levels of Evidence
- Good-quality patient-oriented evidence (i.e., evidence measuring outcomes that matter to patients: morbidity, mortality, symptom improvement, cost reduction, and quality of life)
- Limited-quality patient-oriented evidence
- Other evidence including consensus guidelines, opinion, case studies, or disease-oriented evidence (i.e., evidence measuring intermediate, physiologic, or surrogate end points that may or may not reflect improvements in patient outcomes)
Grades of Recommendation
- Recommendation based on consistent and good quality patient-oriented evidence
- Recommendation based on inconsistent or limited quality patient-oriented evidence
- Recommendation based on consensus, opinion, case studies, or disease-oriented evidence
Note from the National Guideline Clearinghouse (NGC): This document is the first section in a series of four and covers methods for diagnosis and assessment of atopic dermatitis (AD). The second guideline in the series will address the management and treatment of AD with pharmacologic and nonpharmacologic topical modalities; the third section will cover phototherapy and systemic treatment options; and the fourth section will address the minimization of disease flares, educational interventions, and use of adjunctive approaches.
Features to Be Considered in the Diagnosis of Patients with AD
| Essential Features—Must be present:
*Patterns Include:
Important Features—Seen in most cases, adding support to the diagnosis:
Associated Features—These clinical associations help to suggest the diagnosis of AD but are too nonspecific to be used for defining or detecting AD for research and epidemiologic studies:
Exclusionary Conditions—It should be noted that a diagnosis of AD depends on excluding conditions, such as:
Adapted from Eichenfield LF, Hanifin JM, Luger TA, Stevens SR, Pride HB. Consensus conference on pediatric atopic dermatitis. J Am Acad Dermatol 2003;49:1088-95. Used with permission of the American Academy of Dermatology. |
Recommendation for the Diagnosis of AD
Patients with presumed AD should have their diagnosis based on the criteria summarized in the box above. On occasion, skin biopsy specimens or other tests (such as serum immunoglobulin E, potassium hydroxide preparation, patch testing, and/or genetic testing) may be helpful to rule out other or associated skin conditions.
Strength of Recommendations for the Diagnosis and Assessment of AD
| Recommendation | Strength of Recommendation | Level of Evidence | References |
|---|---|---|---|
| Diagnosis made using criteria in the box above | C | III | Mevorah et al., 1988; Gu et al., 2001; Lan et al., 2009; Diepgen, Sauerbrei, & Fartasch, 1996; De, Kanwar, & Handa, 2006; Loden, Andersson, & Lindberg, 1998; Samochocki & Dejewska, 2012; Samochocki, Paulochowska, & Zabielski, 2000; Chalmers et al., 2007; Firooz et al., 1999; Saeki et al., 2007; Firooz & Kashani, 2008; Hamada et al., 2005; Williams et al., 1994; Williams et al., 1996 |
| No specific biomarkers for diagnosis or severity assessment | B | II | Murat-Susic et al., 2006; Schulte-Herbruggen et al., 2007; Amon et al., 2000; Dhar et al., 2005; Gerdes, Kurrat, & Mrowietz, 2009; Aral et al, 2006; Di Lorenzo et al., 2003; El Mongy et al., 2008; Ezzat, Hasan, & Shaheen, 2011; Jahnz-Rozyk et al., 2005; Nakazato et al., 2008; Belloni Fortina et al., 2006; Gutgesell et al., 2002; Hirai et al., 1996; Hon et al., 2007; Horikawa et al., 2002; Kakinuma et al., 2003; La Grutta et al., 2005; Leung et al., 2003; Mostafa et al., 2008; Oflazoglu et al., "CD30 expression," 2008; Oflazoglu et al., "CD40 expression," 2008; Ott et al., 2010; Raap et al., 2006; Song et al., 2006; Wolkerstorfer et al., 1998 |
| Immunoglobulin E levels not routinely recommended | A | I | Schneider et al., 2013; Murat-Susic et al., 2006; Schulte-Herbruggen et al., 2007; Gerdes, Kurrat, & Mrowietz, 2009; Aral et al., 2006; Vakirlis et al., 2011; Wu et al., 2011 |
| Available disease severity scales not for routine clinical use | C | II | Schmitt, Langan, & Williams, 2007; Schram et al., 2012; Sprikkelman et al., 1997; Angelova-Fischer et al., 2005; Wolkerstorfer et al., 1999; Linnet & Jemec, 1999; Hon et al., 2006; Barbier et al., 2004; Charman, Venn, & Williams, 2002; Charman, Venn, & Williams, 2004; Charman et al., 1999; Cosickic et al., 2010; Emerson, Charman, & Williams, 2000; Hanifin et al., 2001; Holm et al., 2007; Oranje et al., 1997; Rullo et al., 2008 |
| Available quality of life severity scales not for routine clinical use | C | II | Chamlin et al., 2007; Augustin et al., 2004; Hon et al, 2006; Misery et al., 2007 |
| Should query itch, sleep, impact on daily activity, and disease persistence | C | III | Chamlin et al., 2005; Hon et al., 2008; Dawn et al., 2009; Lewis-Jones, 2006; Weisshaar et al., 2008; Ricci et al., 2007; Bender et al., 2008; Ben-Gashir, Seed, & Hay, 2002 |
| Awareness and discussion of common associations | C | I and II | Chamlin et al., 2005; Hon et al., 2008; Batlles-Garrido et al., 2010; Chawes et al., 2010; Sultesz et al., 2010; Kyllonen et al., 2006; Hwang et al., 2010; Hyvarinen et al., 2005; Eller et al., 2009; Horwitz, Hossain, & Yousef, 2009; Bashir, Dar, & Rao, 2010; Schmitt et al., "Psychiatric comorbidity," 2009; Schmitt et al., "Atopic eczema," 2009; Yaghmaie, Koudelka, & Simpson, 2013; Harding et al., 2008; Synnerstad et al., 2008; Vajdic et al., 2009; Kajbaf, Asar, & Alipoor, 2011; Vlaski et al., 2006 |
| Integrated, multidisciplinary approach to care | C | III | Boguniewicz et al., 2008; Ricci et al., 2009 |
Recommendations for the Use of Biomarkers in the Assessment of AD
- For patients with presumed AD, there are no specific biomarkers that can be recommended for diagnosis and/or assessment of disease severity.
- Monitoring of immunoglobulin E levels is not recommended for the routine assessment of disease severity.
Recommendations for Disease Severity and Clinical Outcomes Assessment
- For the general management of patients with AD, available disease severity measurement scales are not recommended for routine clinical practice, because they were not usually designed for this purpose.
- For the general management of patients with AD, available patient quality of life measurement scales are not recommended for routine clinical practice.
- It is recommended that clinicians ask general questions about itch, sleep, impact on daily activity, and persistence of disease, and currently available scales be used mainly when practical.
Recommendations for the Assessment of Clinical Associations of AD
- Physicians should be aware of and assess for conditions associated with AD, such as rhinitis/rhinoconjunctivitis, asthma, food allergy, sleep disturbance, depression, and other neuropsychiatric conditions, and it is recommended that physicians discuss them with the patient as part of the treatment/management plan, when appropriate.
- An integrated, multidisciplinary approach to care may be valuable and is suggested for AD patients who present with common associations.
Definitions:
Levels of Evidence
- Good-quality patient-oriented evidence (i.e., evidence measuring outcomes that matter to patients: morbidity, mortality, symptom improvement, cost reduction, and quality of life)
- Limited-quality patient-oriented evidence
- Other evidence including consensus guidelines, opinion, case studies, or disease-oriented evidence (i.e., evidence measuring intermediate, physiologic, or surrogate end points that may or may not reflect improvements in patient outcomes)
Grades of Recommendation
- Recommendation based on consistent and good quality patient-oriented evidence
- Recommendation based on inconsistent or limited quality patient-oriented evidence
- Recommendation based on consensus, opinion, case studies, or disease-oriented evidence
Note from the National Guideline Clearinghouse (NGC): This document is the first section in a series of four and covers methods for diagnosis and assessment of atopic dermatitis (AD). The second guideline in the series will address the management and treatment of AD with pharmacologic and nonpharmacologic topical modalities; the third section will cover phototherapy and systemic treatment options; and the fourth section will address the minimization of disease flares, educational interventions, and use of adjunctive approaches.
Features to Be Considered in the Diagnosis of Patients with AD
| Essential Features—Must be present:
*Patterns Include:
Important Features—Seen in most cases, adding support to the diagnosis:
Associated Features—These clinical associations help to suggest the diagnosis of AD but are too nonspecific to be used for defining or detecting AD for research and epidemiologic studies:
Exclusionary Conditions—It should be noted that a diagnosis of AD depends on excluding conditions, such as:
Adapted from Eichenfield LF, Hanifin JM, Luger TA, Stevens SR, Pride HB. Consensus conference on pediatric atopic dermatitis. J Am Acad Dermatol 2003;49:1088-95. Used with permission of the American Academy of Dermatology. |
Recommendation for the Diagnosis of AD
Patients with presumed AD should have their diagnosis based on the criteria summarized in the box above. On occasion, skin biopsy specimens or other tests (such as serum immunoglobulin E, potassium hydroxide preparation, patch testing, and/or genetic testing) may be helpful to rule out other or associated skin conditions.
Strength of Recommendations for the Diagnosis and Assessment of AD
| Recommendation | Strength of Recommendation | Level of Evidence | References |
|---|---|---|---|
| Diagnosis made using criteria in the box above | C | III | Mevorah et al., 1988; Gu et al., 2001; Lan et al., 2009; Diepgen, Sauerbrei, & Fartasch, 1996; De, Kanwar, & Handa, 2006; Loden, Andersson, & Lindberg, 1998; Samochocki & Dejewska, 2012; Samochocki, Paulochowska, & Zabielski, 2000; Chalmers et al., 2007; Firooz et al., 1999; Saeki et al., 2007; Firooz & Kashani, 2008; Hamada et al., 2005; Williams et al., 1994; Williams et al., 1996 |
| No specific biomarkers for diagnosis or severity assessment | B | II | Murat-Susic et al., 2006; Schulte-Herbruggen et al., 2007; Amon et al., 2000; Dhar et al., 2005; Gerdes, Kurrat, & Mrowietz, 2009; Aral et al, 2006; Di Lorenzo et al., 2003; El Mongy et al., 2008; Ezzat, Hasan, & Shaheen, 2011; Jahnz-Rozyk et al., 2005; Nakazato et al., 2008; Belloni Fortina et al., 2006; Gutgesell et al., 2002; Hirai et al., 1996; Hon et al., 2007; Horikawa et al., 2002; Kakinuma et al., 2003; La Grutta et al., 2005; Leung et al., 2003; Mostafa et al., 2008; Oflazoglu et al., "CD30 expression," 2008; Oflazoglu et al., "CD40 expression," 2008; Ott et al., 2010; Raap et al., 2006; Song et al., 2006; Wolkerstorfer et al., 1998 |
| Immunoglobulin E levels not routinely recommended | A | I | Schneider et al., 2013; Murat-Susic et al., 2006; Schulte-Herbruggen et al., 2007; Gerdes, Kurrat, & Mrowietz, 2009; Aral et al., 2006; Vakirlis et al., 2011; Wu et al., 2011 |
| Available disease severity scales not for routine clinical use | C | II | Schmitt, Langan, & Williams, 2007; Schram et al., 2012; Sprikkelman et al., 1997; Angelova-Fischer et al., 2005; Wolkerstorfer et al., 1999; Linnet & Jemec, 1999; Hon et al., 2006; Barbier et al., 2004; Charman, Venn, & Williams, 2002; Charman, Venn, & Williams, 2004; Charman et al., 1999; Cosickic et al., 2010; Emerson, Charman, & Williams, 2000; Hanifin et al., 2001; Holm et al., 2007; Oranje et al., 1997; Rullo et al., 2008 |
| Available quality of life severity scales not for routine clinical use | C | II | Chamlin et al., 2007; Augustin et al., 2004; Hon et al, 2006; Misery et al., 2007 |
| Should query itch, sleep, impact on daily activity, and disease persistence | C | III | Chamlin et al., 2005; Hon et al., 2008; Dawn et al., 2009; Lewis-Jones, 2006; Weisshaar et al., 2008; Ricci et al., 2007; Bender et al., 2008; Ben-Gashir, Seed, & Hay, 2002 |
| Awareness and discussion of common associations | C | I and II | Chamlin et al., 2005; Hon et al., 2008; Batlles-Garrido et al., 2010; Chawes et al., 2010; Sultesz et al., 2010; Kyllonen et al., 2006; Hwang et al., 2010; Hyvarinen et al., 2005; Eller et al., 2009; Horwitz, Hossain, & Yousef, 2009; Bashir, Dar, & Rao, 2010; Schmitt et al., "Psychiatric comorbidity," 2009; Schmitt et al., "Atopic eczema," 2009; Yaghmaie, Koudelka, & Simpson, 2013; Harding et al., 2008; Synnerstad et al., 2008; Vajdic et al., 2009; Kajbaf, Asar, & Alipoor, 2011; Vlaski et al., 2006 |
| Integrated, multidisciplinary approach to care | C | III | Boguniewicz et al., 2008; Ricci et al., 2009 |
Recommendations for the Use of Biomarkers in the Assessment of AD
- For patients with presumed AD, there are no specific biomarkers that can be recommended for diagnosis and/or assessment of disease severity.
- Monitoring of immunoglobulin E levels is not recommended for the routine assessment of disease severity.
Recommendations for Disease Severity and Clinical Outcomes Assessment
- For the general management of patients with AD, available disease severity measurement scales are not recommended for routine clinical practice, because they were not usually designed for this purpose.
- For the general management of patients with AD, available patient quality of life measurement scales are not recommended for routine clinical practice.
- It is recommended that clinicians ask general questions about itch, sleep, impact on daily activity, and persistence of disease, and currently available scales be used mainly when practical.
Recommendations for the Assessment of Clinical Associations of AD
- Physicians should be aware of and assess for conditions associated with AD, such as rhinitis/rhinoconjunctivitis, asthma, food allergy, sleep disturbance, depression, and other neuropsychiatric conditions, and it is recommended that physicians discuss them with the patient as part of the treatment/management plan, when appropriate.
- An integrated, multidisciplinary approach to care may be valuable and is suggested for AD patients who present with common associations.
Definitions:
Levels of Evidence
- Good-quality patient-oriented evidence (i.e., evidence measuring outcomes that matter to patients: morbidity, mortality, symptom improvement, cost reduction, and quality of life)
- Limited-quality patient-oriented evidence
- Other evidence including consensus guidelines, opinion, case studies, or disease-oriented evidence (i.e., evidence measuring intermediate, physiologic, or surrogate end points that may or may not reflect improvements in patient outcomes)
Grades of Recommendation
- Recommendation based on consistent and good quality patient-oriented evidence
- Recommendation based on inconsistent or limited quality patient-oriented evidence
- Recommendation based on consensus, opinion, case studies, or disease-oriented evidence
Atopic dermatitis affects up to 25% of children and 2% to 3% of adults. This guideline addresses methods for the diagnosis and monitoring of disease, outcomes measures for assessment, and common clinical associations that affect patients with AD are discussed.
Guidelines are copyright © 2013 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved. The summary is provided by the Agency for Healthcare Research and Quality