Melissa J. Armstrong

Practice guideline summary: Treatment of restless legs syndrome in adults Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology

Objective: To make evidence-based recommendations regarding restless legs syndrome (RLS) management in adults. Methods: Articles were classified per the 2004 American Academy of Neurology evidence rating scheme. Recommendations were tied to evidence strength. Results and recommendations: In moderate to severe primary RLS, clinicians should consider prescribing medication to reduce RLS symptoms. Strong evidence supports pramipexole, rotigotine, cabergoline, and gabapentin enacarbil use (Level A); moderate evidence supports ropinirole, pregabalin, and IV ferric carboxymaltose use (Level B). Clinicians may consider prescribing levodopa (Level C). Few head-to-head comparisons exist to suggest agents preferentially. Cabergoline is rarely used (cardiac valvulopathy risks). Augmentation risks with dopaminergic agents should be considered. When treating periodic limb movements of sleep, clinicians should consider prescribing ropinirole (Level A) or pramipexole, rotigotine, cabergoline, or pregabalin (Level B). For subjective sleep measures, clinicians should consider prescribing cabergoline or gabapentin enacarbil (Level A), or ropinirole, pramipexole, rotigotine, or pregabalin (Level B). For patients failing other treatments for RLS symptoms, clinicians may consider prescribing prolonged-release oxycodone/naloxone where available (Level C). In patients with RLS with ferritin ≤75 μg/L, clinicians should consider prescribing ferrous sulfate with vitamin C (Level B). When nonpharmacologic approaches are desired, clinicians should consider prescribing pneumatic compression (Level B) and may consider prescribing near-infrared spectroscopy or transcranial magnetic stimulation (Level C). Clinicians may consider prescribing vibrating pads to improve subjective sleep (Level C). In patients on hemodialysis with secondary RLS, clinicians should consider prescribing vitamin C and E supplementation (Level B) and may consider prescribing ropinirole, levodopa, or exercise (Level C).

Framework for enhancing clinical practice guidelines through continuous patient engagement

Patient engagement in clinical practice guideline (CPG) development is recommended by multiple institutions and instruments measuring guideline quality. Approaches to engaging patients, however, vary between oversight organizations, quality tools and guideline developers.

Practice guideline summary: Reducing brain injury following cardiopulmonary resuscitation Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology

Objective: To assess the evidence and make evidence-based recommendations for acute interventions to reduce brain injury in adult patients who are comatose after successful cardiopulmonary resuscitation. Methods: Published literature from 1966 to August 29, 2016, was reviewed with evidence-based classification of relevant articles. Results and recommendations: For patients who are comatose in whom the initial cardiac rhythm is either pulseless ventricular tachycardia (VT) or ventricular fibrillation (VF) after out-of-hospital cardiac arrest (OHCA), therapeutic hypothermia (TH; 32–34°C for 24 hours) is highly likely to be effective in improving functional neurologic outcome and survival compared with non-TH and should be offered (Level A). For patients who are comatose in whom the initial cardiac rhythm is either VT/VF or asystole/pulseless electrical activity (PEA) after OHCA, targeted temperature management (36°C for 24 hours, followed by 8 hours of rewarming to 37°C, and temperature maintenance below 37.5°C until 72 hours) is likely as effective as TH and is an acceptable alternative (Level B). For patients who are comatose with an initial rhythm of PEA/asystole, TH possibly improves survival and functional neurologic outcome at discharge vs standard care and may be offered (Level C). Prehospital cooling as an adjunct to TH is highly likely to be ineffective in further improving neurologic outcome and survival and should not be offered (Level A). Other pharmacologic and nonpharmacologic strategies (applied with or without concomitant TH) are also reviewed.

Use of theory to plan or evaluate guideline implementation among physicians: A scoping review

BackgroundGuidelines support health care decision-making and high quality care and outcomes. However, their implementation is sub-optimal. Theory-informed, tailored implementation is associated with guideline use. Few guideline implementation studies published up to 1998 employed theory. This study aimed to describe if and how theory is now used to plan or evaluate guideline implementation among physicians.MethodsA scoping review was conducted. MEDLINE, EMBASE, and The Cochrane Library were searched from 2006 to April 2016. English language studies that planned or evaluated guideline implementation targeted to physicians based on explicitly named theory were eligible. Screening and data extraction were done in duplicate. Study characteristics and details about theory use were analyzed.ResultsA total of 1244 published reports were identified, 891 were unique, and 716 were excluded based on title and abstract. Among 175 full-text articles, 89 planned or evaluated guideline implementation targeted to physicians; 42 (47.2%) were based on theory and included. The number of studies using theory increased yearly and represented a wide array of countries, guideline topics and types of physicians. The Theory of Planned Behavior (38.1%) and the Theoretical Domains Framework (23.8%) were used most frequently. Many studies rationalized choice of theory (83.3%), most often by stating that the theory described implementation or its determinants, but most failed to explicitly link barriers with theoretical constructs. The majority of studies used theory to inform surveys or interviews that identified barriers of guideline use as a preliminary step in implementation planning (76.2%). All studies that evaluated interventions reported positive impact on reported physician or patient outcomes.ConclusionsWhile the use of theory to design or evaluate interventions appears to be increasing over time, this review found that one half of guideline implementation studies were based on theory and many of those provided scant details about how theory was used. This limits interpretation and replication of those interventions, and seems to result in multifaceted interventions, which may not be feasible outside of scientific investigation. Further research is needed to better understand how to employ theory in guideline implementation planning or evaluation.

Value Assessment at the Point of Care: Incorporating Patient Values throughout Care Delivery and a Draft Taxonomy of Patient Values ☆

Incorporation of patient values is a key element of patient-centered care, but consistent incorporation of patient values at the point of care is lacking. Shared decision making encourages incorporation of patient values in decision making, but associated tools often lack guidance on value assessment. In addition, focusing on patient values relating only to specific decisions misses an opportunity for a more holistic approach to value assessment that could impact other aspects of clinical encounters, including health care planning, communication, and stakeholder involvement. In this commentary, we propose a taxonomy of values underlying patient decision making and provide examples of how these impact provision of health care. The taxonomy describes four categories of patient values: global, decisional, situational, and external. Global values are personal values impacting decision making at a universal level and can include value traits and life priorities. Decisional values are the values traditionally conceptualized in decision making, including considerations such as efficacy, toxicity, quality of life, convenience, and cost. Situational values are values tied to a specific moment in time that modify patients existing global and decisional values. Finally, discussion of external values acknowledges that many patients consider values other than their own when making decisions. Recognizing the breadth of values impacting patient decision making has implications for both overall health care delivery and shared decision making because value assessments focusing only on decisional values may miss important patient considerations. This draft taxonomy highlights different values impacting decision making and facilitates a more complete value assessment at the point of care.

Patient involvement in guidelines is poor five years after institute of medicine standards: review of guideline methodologies

Plain English summaryThe 2011 standards for trustworthy development of healthcare guidelines published by the United States-based Institute of Medicine recommend that guideline developers involve patients and public representatives in the development process. The standards recommend that (1) patients and the public be actively involved as members on guideline development panels and (2) guideline developers seek patient and public input during review of the draft guideline. In this study, researchers reviewed the patient and public involvement strategies of guideline developers in the United States by looking at websites and guideline development practices. Of 101 organizations reviewed, only 8% require patient and public involvement on guideline development groups; 15% sometimes require it or describe it as optional. Only 24% of guideline developers always post draft guidelines for public comment. Thirteen percent of guideline developers ask patients or patient organizations to review draft guidelines at least some of the time. Only 20% of guideline developers create patient-targeted guideline products (e.g. patient summaries of guidelines). These low numbers show that there is a substantial gap between standards for patient and public involvement in guideline development and what is actually happening. This is a missed opportunity, as patient and public contributions to guideline development include assessing guideline priorities, introducing new topics, identifying important populations and outcomes, suggesting whether findings are meaningful, prompting holistic approaches to care, assessing how recommendations interact with patient values, and writing plain-language guideline versions. Guideline developers must commit to prioritizing patient and public involvement as one part of trustworthy guideline development.AbstractBackgroundThe United States-based Institute of Medicine 2011 standards for trustworthy clinical practice guideline development recommended patient and public involvement in guideline development via participation by patients and public representatives on guideline development groups and via external review and public comment strategies. Guideline developer compliance with these standards has not been assessed. This study aimed to identify the frequency with which United States guideline developers are employing participation, consultation, and communication patient and public involvement strategies.MethodsTwo reviewers independently extracted current patient and public involvement strategies of independent guideline developers, either (1) an organizational member of the Guidelines-International-Network North America and/or (2) having ≥2 guidelines in the National Guideline Clearinghouse between March 2011 and November 2015. Publicly available information was extracted from guideline developers’ websites, methodology manuals, and guidelines between November 2015 and December 2016. Disagreements were resolved by discussion.ResultsOf 101 organizations meeting inclusion criteria, only 8% require patient/public involvement on guideline development groups; 15% sometimes require it or describe it as optional. Only 24% always utilize public comment on draft guidelines; 13% engage patients/public in external review at least some of the time. Twenty percent of developers create patient-targeted guideline products.ConclusionsThere remains a substantial gap between patient/public involvement standards for guideline development and practice in the United States, even 5xa0years after publication of Institute of Medicine standards. This is a missed opportunity, as patient and public contributions to guideline development include assessing guideline priorities, introducing new topics, identifying key populations and outcomes, informing whether findings are meaningful, prompting holistic approaches to care, assessing how recommendations interact with patient values, and writing plain-language guideline versions. Guideline developers must commit to prioritizing patient and public involvement as one element of trustworthy guideline development.

The Case for Antipsychotics in Dementia with Lewy Bodies

Recurrent visual hallucinations are a core feature of dementia with Lewy bodies (DLB). While the spectrum of behavioral and psychological symptoms of dementia in DLB is broader than psychosis alone—also including anxiety, depression, apathy, and agitation—hallucinations and delusions (i.e., psychosis) are common in patients with DLB and are a key issue in living with the disease. Hallucinations were described in 76% and delusions in 57% of patients with DLB in 1 cross-sectional study. When comparing mild versus moderate-severe DLB (as determined by the severity of cognitive impairment), psychosis frequency increased from 50% to over 75%. Specifically, hallucinations increased from 30% to 70%, and delusions increased from 20% to over 50%. Other research shows that delusion and hallucination scores on the Neuropsychiatric Inventory are high in DLB regardless of dementia severity. Delusions are an important determinant of quality of life (QoL) in DLB as assessed by both patients and caregivers. Behavioral disturbances are associated with depression in DLB caregivers and are major contributors to caregiver distress and strain. Although research is lacking with regard to the determinants of institutionalization in DLB, Parkinson’s disease (PD) studies show that psychosis is the main risk factor for nursing home placement. The management of hallucinations and delusions in DLB is challenging, however. Antipsychotics have risks in patients with DLB. “Severe neuroleptic sensitivity” is a suggestive feature in DLB clinical diagnostic criteria, in part based on research showing that 81% of patients with DLB who received typical antipsychotics had adverse reactions, one-half of which were severe. Atypical antipsychotics received a black-box warning from the US Food and Drug Administration (FDA) in 2005 due to an increased risk of death in patients with dementia-related behavioral disturbances. This warning was extended to typical antipsychotics in 2008. Studies demonstrate an increased risk of death in patients with dementia who are treated with antipsychotics in both the short and long term. Recent evidence also shows an increased mortality risk in patients with PD who are treated with typical and atypical antipsychotics. Besides the obvious risk of worsened parkinsonism with antipsychotics, some studies suggest that antipsychotic use is associated with an increased rate of cognitive decline in dementia in both community settings and Alzheimer’s disease clinical trials. The benefits of antipsychotics in DLB are uncertain, but few alternatives exist. A meta-analysis of pharmacologic strategies for the closely related Lewy body dementias (LBDs) (i.e., both DLB and PD dementia [PDD]) found few studies of antipsychotic agents in these conditions. In the small studies cited, often with limited methodologic rigor, there was no evidence for efficacy and also a limited ability to exclude potentially beneficial effects. When considering PDD with psychosis, a Movement Disorder Society evidence-based medicine review concluded that clozapine was “efficacious” and had an acceptable risk with specialized monitoring; quetiapine was considered “investigational” given a lack of supporting evidence; and olanzapine was characterized as “unlikely efficacious” and as having “unacceptable risk” given clearly demonstrated worsening of motor function. In considering antipsychotic alternatives, a systematic review of 22 pharmacologic strategies for DLB found that only cholinesterase inhibitors (donepezil and rivastigmine) had high-level evidence for either cognitive or psychiatric symptoms in DLB, but evidence of benefit on neuropsychiatric symptoms was limited and included the possibility of no effect. Furthermore, 25% of patients with DLB and PDD who were receiving cholinesterase inhibitors withdrew from treatment trials, suggesting that substantial numbers of patients with DLB may not tolerate

Impact of patient involvement on clinical practice guideline development: a parallel group study

BackgroundPatient and public involvement (PPI) is recognized as a key component of clinical practice guideline development with important implications for guideline implementability. The impact of PPI on guidelines, however, has not been rigorously assessed. Better understanding of the impact of PPI must start with guideline question formation, which drives all subsequent development steps. The aim of this study was to investigate the effect of PPI on guideline question formation and validate a conceptual model of patient and public contributions to guidelines.MethodsFor development of a clinical practice guideline on the topic of using amyloid positron emission tomography in the diagnosis of dementia, we convened two parallel guideline development groups, one with and one without patient representatives. Participating physicians were randomized to group assignment. Each group developed Population, Intervention, Comparator, Outcome, Time (PICOT) questions and identified key benefits and harms to incorporate in guideline development. Analysis included a descriptive comparison of proposed PICOT questions, benefits, and harms between groups and a qualitative analysis of discussion themes from audio recordings of the question development retreats.ResultsProposed guideline questions, benefits, and harms were largely similar between groups, but only the experimental group proposed outcomes relating to development of cognitive impairment at specific time points and rate of progression. The qualitative analysis of the discussions occurring during guideline question development demonstrated key differences in group conduct and validated the proposed conceptual model of patient and public contributions to guidelines. PPI influenced the conduct of guideline development, scope, inclusion of patient-relevant topics, outcome selection, and planned approaches to recommendation development, implementation, and dissemination with implications for both guideline developers and the guideline development process.ConclusionsEvidence of how PPI impacts guideline development underscores the importance of engaging patient stakeholders in guideline development and highlights developer- and guideline-specific outcomes of PPI, both of which have implications for guideline implementation. It also raises the question of whether guidelines developed without such input are acceptable for use. PPI should be considered an essential element of trustworthy guideline development for purposes of development and funding.

Practice Guideline Update Recommendations Summary: Disorders of Consciousness: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology; the American Congress of Rehabilitation Medicine; and the National Institute on Disability, Independent Living, and Rehabilitation Research

OBJECTIVEnTo update the 1995 American Academy of Neurology (AAN) practice parameter on persistent vegetative state and the 2002 case definition on minimally conscious state (MCS) and provide care recommendations for patients with prolonged disorders of consciousness (DoC).nnnMETHODSnRecommendations were based on systematic review evidence, related evidence, care principles, and inferences using a modified Delphi consensus process according to the AAN 2011 process manual, as amended.nnnRECOMMENDATIONSnClinicians should identify and treat confounding conditions, optimize arousal, and perform serial standardized assessments to improve diagnostic accuracy in adults and children with prolonged DoC (Level B). Clinicians should counsel families that for adults, MCS (vs vegetative state [VS]/ unresponsive wakefulness syndrome [UWS]) and traumatic (vs nontraumatic) etiology are associated with more favorable outcomes (Level B). When prognosis is poor, long-term care must be discussed (Level A), acknowledging that prognosis is not universally poor (Level B). Structural MRI, SPECT, and the Coma Recovery Scale-Revised can assist prognostication in adults (Level B); no tests are shown to improve prognostic accuracy in children. Pain always should be assessed and treated (Level B) and evidence supporting treatment approaches discussed (Level B). Clinicians should prescribe amantadine (100-200 mg bid) for adults with traumatic VS/UWS or MCS (4-16 weeks post injury) to hasten functional recovery and reduce disability early in recovery (Level B). Family counseling concerning children should acknowledge that natural history of recovery, prognosis, and treatment are not established (Level B). Recent evidence indicates that the term chronic VS/UWS should replace permanent VS, with duration specified (Level B). Additional recommendations are included.

Improving email strategies to target stress and productivity in clinical practice

Abstract Physician burnout is gaining increased attention in medicine and neurology and often relates to hours worked and insufficient time. One component of this is administrative burden, which relates to regulatory requirements and electronic health record tasks but may also involve increased time spent processing emails. Research in academic medical centers demonstrates that physicians face increasing inbox sizes related to mass distribution emails from various sources on top of emails required for patient care, research, and teaching. This commentary highlights the contribution of administrative tasks to physician burnout, research to date on email in medical contexts, and corporate strategies for reducing email burden that are applicable to neurology clinical practice. Increased productivity and decreased stress can be achieved by limiting the amount one accesses email, managing inbox size, and utilizing good email etiquette. Department and practice physician leaders have roles in decreasing email volume and modeling good practice.