Nonpharmacological Self-Management of Migraine Across Social Locations: An Equity-Oriented, Qualitative Analysis.

BACKGROUND: Migraine is a disabling neurological disorder and the sixth biggest cause of disability worldwide. The World Health Organization has declared migraine a major public health problem due to a paucity of knowledge about cause and effective treatment options. Both in incidence and severity, migraine disproportionately affects people occupying marginalized social locations (SL). Managed pharmacologically, migraine is treated with daily preventive and as-needed abortive medications. Both come with high literal and figurative costs: intolerable side effects, medication interactions, and prohibitive prices. Cost prohibitive, ineffective, and unsustainable pharmacological treatment options have contributed to high levels of interest in complementary approaches by people with migraine, but little is known about their motivations, patterns of use or access, or how these may vary by SL. METHOD: We conducted focus groups with 30 people with migraine to explore their desires and recommendations for migraine clinicians and researchers. We used qualitative content analysis to identify themes.Outcomes: We identified 4 themes: a more holistic, collaborative, long-term treatment approach; medication as a short-term solution; high personal and economic costs of medication; and desire for more information and access to natural approaches. Across SL, participants expressed keen interest in integrative approaches and wanted better access to complementary modalities. Participants in marginalized SL described reliance on traditional/folk remedies, including engagement with family and community healers, who they described as more affordable and culturally accessible. CONCLUSIONS: Holistic and integrative approaches were preferred over medication as long-term migraine management strategies. However, people in marginalized SL, while disproportionately disabled by migraine, did not feel as comfortable accessing integrative approaches through currently available channels. Engaging with these communities and using a critical lens to explore barriers to access can develop options to make complementary modalities more approachable, while also attending to systemic blind spots that may unintentionally alienate socially marginalized groups.

A pooled analysis of three studies of nonpharmacological interventions for menopausal hot flashes.

OBJECTIVE: The aim of the study was to conduct a pooled analysis of three published trials of nonpharmacological interventions for menopausal hot flashes to compare the effectiveness of interventions. METHODS: Data from three randomized controlled trials of interventions for hot flashes (two acupuncture trials, one yoga trial) were pooled. All three studies recruited perimenopausal or postmenopausal women experiencing ≥4 hot flashes/d on average. The primary outcome for all three studies was frequency of hot flashes as measured by the Daily Diary of Hot Flashes. Study 1 participants were randomly assigned to 8 weeks of acupuncture treatments (active intervention), sham acupuncture (attention control), or usual care. Study 2 participants were randomly assigned to 10 weeks of yoga classes, health and wellness education classes (attention control), or waitlist control. Study 3 randomly assigned participants to 6 months of acupuncture or waitlist control. To standardize the time frame for these analyses, only the first 8 weeks of intervention from all three studies were used. RESULTS: The three active interventions and the two attention control groups had statistically similar trends in the percentage reduction of hot flashes over 8 weeks, ranging from 35% to 40%. These five groups did not differ significantly from each other, but all showed significantly greater reduction in hot flash frequency compared with the three usual care/waitlist groups. CONCLUSION: Acupuncture, yoga, and health and wellness education classes all demonstrated statistically similar effectiveness in reduction of hot flash frequency compared with controls.

A Critical Exploration of Migraine as a Health Disparity: the Imperative of an Equity-Oriented, Intersectional Approach.

PURPOSE OF REVIEW: Despite recognition of rising prevalence and significant burden, migraine remains underestimated, underdiagnosed, and undertreated. This is especially true among groups who have been historically, socially, and economically marginalized such as communities of color, women, people experiencing poverty, people with lower levels of education, and people who hold more than one of these marginalized identities. While there is growing public and professional interest in disparities in migraine prevalence, there is a paucity of research focusing on racial/ethnic and socioeconomic disparities, and the social and structural determinants of health and equity that perpetuate these disparities. From a health equity perspective, migraine research and treatment require an examination not only of biological and behavioral factors, but of these identities and underlying, intersecting social and structural determinants of health. RECENT FINDINGS: Significant disparities in migraine incidence, prevalence, migraine-related pain and disability, access to care, and quality of care persist among marginalized and underserved groups: African Americans, Hispanics, people experiencing poverty, un- or under-employment, the un- and under-insured, people who have been exposed to stressful and traumatic events across the lifespan, and people experiencing multiple, overlapping marginalized identities. These same groups are largely underrepresented in migraine research, despite bearing disproportionate burden. Current approaches to understanding health disparities in migraine largely assume an essentializing approach, i.e., documenting differences between single identity groups-e.g., race or income or education level-rather than considering the mechanisms of disparities: the social and structural determinants of health. While disparities in migraine are becoming more widely acknowledged, we assert that migraine is more aptly understood as a health equity issue, that is, a condition in which many of the health disparities are avoidable. It is important in research and clinical practice to consider perspectives that incorporate a cultural understanding of racial, ethnic, and socioeconomic identity within and across all levels of society. Incorporating perspectives of intersectionality provides a strong foundation for understanding the role of these complex combination of factors on migraine pain and treatment. We urge the adoption of intersectional and systems perspectives in research, clinical practice, and policy to examine (1) interplay of race, gender, and social location as key factors in understanding, diagnosing, and treating migraine, and (2) the complex configurations of social and structural determinants of health that interact to produce health inequities in migraine care. An intentional research and clinical focus on these factors stands to improve how migraine is identified, documented, and treated among marginalized populations.

A Qualitative, Systems Thinking Approach to Study Self-Management in Women With Migraine.

BACKGROUND: A dearth of effective and affordable treatment options has rendered nonpharmacological self-management a crucial part of living with migraine-a debilitating neurobiological condition without cure that disproportionately disables vulnerable women. OBJECTIVE: The aim of the study was to describe the development and use of a systems thinking, problem-structuring data collection approach that was applied to the study of migraine self-management with women in diverse social locations. METHODS: Two systems mapping activities were developed for use in focus groups: one to unpack a migraine episode (system support map) and the other (connection circle [CC]) to construct a mental model of self-management. Later in the process, a strengths-based problem-solving tool was developed to replace the CC. RESULTS: The CCs-often enlightening for affluent participants-left marginalized women feeling overwhelmed and defeated, as a solution to one challenge became the cause of another. Through constant comparison analysis, we recalibrated the approach using a theory, clinical experience, and participant feedback and replaced the CC with a strengths-based problem-solving activity highlighting relationships and trade-offs in a more agential, actionable way. DISCUSSION: Bringing a critical lens and strengths-based approaches to work with vulnerable populations can replace traditional deficit thinking in healthcare, developing options for leveraging resources and understanding complex health behaviors without losing sight of systemic, distributional justice issues. These systems thinking tools can provide a way to extrapolate the complexities of actual self-management behaviors and challenges faced by vulnerable women with migraine versus what they may be instructed to do by a medical model that does not always account for the social and structural determinants of equity and health.

Nonpharmacologic Treatments for Attention-Deficit/Hyperactivity Disorder: A Systematic Review.

CONTEXT: Nonpharmacologic treatments for attention-deficit/hyperactivity disorder (ADHD) encompass a range of care approaches from structured behavioral interventions to complementary medicines. OBJECTIVES: To assess the comparative effectiveness of nonpharmacologic treatments for ADHD among individuals 17 years of age and younger. DATA SOURCES: PubMed, Embase, PsycINFO, and Cochrane Database of Systematic Reviews for relevant English-language studies published from January 1, 2009 through November 7, 2016. STUDY SELECTION: We included studies that compared any ADHD nonpharmacologic treatment strategy with placebo, pharmacologic, or another nonpharmacologic treatment. DATA EXTRACTION: Study design, patient characteristics, intervention approaches, follow-up times, and outcomes were abstracted. For comparisons with at least 3 similar studies, random-effects meta-analysis was used to generate pooled estimates. RESULTS: We identified 54 studies of nonpharmacologic treatments, including neurofeedback, cognitive training, cognitive behavioral therapy, child or parent training, dietary omega fatty acid supplementation, and herbal and/or dietary approaches. No new guidance was identified regarding the comparative effectiveness of nonpharmacologic treatments. Pooled results for omega fatty acids found no significant effects for parent rating of ADHD total symptoms (n = 411; standardized mean difference -0.32; 95% confidence interval -0.80 to 0.15; I2 = 52.4%; P = .10) or teacher-rated total ADHD symptoms (n = 287; standardized mean difference -0.08; 95% confidence interval -0.47 to 0.32; I2 = 0.0%; P = .56). LIMITATIONS: Studies often did not reflect the primary care setting and had short follow-up periods, small sample sizes, variations in outcomes, and inconsistent reporting of comparative statistical analyses. CONCLUSIONS: Despite wide use, there are significant gaps in knowledge regarding the effectiveness of ADHD nonpharmacologic treatments.

Acupuncture for Chronic Pain in the Vermont Medicaid Population: A Prospective, Pragmatic Intervention Trial.

INTRODUCTION: In response to the opioid crisis, the 2016 Vermont legislature commissioned a study to assess acupuncture for patients with chronic pain in the Vermont Medicaid population. OBJECTIVE: To assess the feasibility, acceptability, and effectiveness of acupuncture provided by licensed acupuncturists for Vermont Medicaid patients with chronic pain. METHODS: A total of 156 Medicaid patients with chronic pain were offered up to 12 acupuncture treatments within a 60-day period at the offices of 28 Vermont licensed acupuncturists. PROMIS® questionnaires were administered prior to and at the end of the treatment period to assess changes in pain intensity, pain interference, physical function, fatigue, anxiety, depression, sleep disturbance, and social isolation. Questionnaires also captured patients' overall impressions of treatments as well as self-reported changes in medication use and work function. RESULTS: One hundred eleven women (71%) and 45 men (29%) with a wide range of pain complaints received a mean of 8.2 treatments during the intervention period. Measurements captured prior to and at the end of the treatment period showed significant improvements in group mean pain intensity, pain interference, physical function, fatigue, anxiety, depression, sleep disturbance, and social isolation as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) measures (paired t tests, P < .01). Fifty-seven percent of patients using analgesic (nonopioid) medication reported reductions in use. Thirty-two percent of patients using opioid medication reported reductions in use of opioid medication following the intervention. Seventy-four percent of employed patients reported improved capacity to work. Ninety-six percent of patients said that they would recommend acupuncture to others with chronic pain, and 91% reported qualitative improvements, including physical (31%), functional/behavioral (29%), and psycho-emotional (24%) improvements. CONCLUSIONS: Our findings demonstrate that acupuncture treatment for chronic pain is feasible and well received by patients in the Vermont Medicaid population. Receiving care from Licensed Acupuncturists was associated with significant improvements in physical, functional, psycho-emotional, and occupational outcomes compared with before receiving acupuncture treatments.

Management of Menopause Symptoms with Acupuncture: An Umbrella Systematic Review and Meta-Analysis.

OBJECTIVES: Vasomotor symptoms (VMSs) are the most common symptoms reported during menopause. Although hormone therapy is effective for reducing VMSs, its use is restricted in some women. Many women with VMSs thus seek nonhormonal, nonpharmacologic treatment options such as acupuncture. DESIGN: An umbrella systematic review (SR) was conducted, supplemented by a search of published randomized controlled trials (RCTs), that assessed the effectiveness of acupuncture for VMSs, health-related quality of life (HRQOL), and adverse effects of treatment in perimenopausal or postmenopausal women. Meta-analyses were conducted using a random-effects model when data were sufficient. RESULTS: Three SRs and four new RCTs were identified that met eligibility criteria. Meta-analyses of this study revealed statistically significant standardized mean differences (SMDs) associated with acupuncture compared with no acupuncture at reducing VMS frequency (SMD -0.66, 95% confidence interval [CI] -1.06 to -0.26, I2 = 61.7%, 5 trials) and VMS severity (SMD -0.49, 95% CI -0.85 to -0.13, I2 = 18.1%, 4 trials) and improving HRQOL outcomes (SMD -0.93, 95% CI -1.20 to -0.67, I2 = 0.0%, 3 trials). SMDs were smaller or not statistically significant when acupuncture was compared with sham acupuncture. CONCLUSIONS: Evidence from RCTs supports the use of acupuncture as an adjunctive or stand-alone treatment for reducing VMSs and improving HRQOL outcomes, with the caveat that observed clinical benefit associated with acupuncture may be due, in part, or in whole to nonspecific effects. The safety of acupuncture in the treatment of VMSs has not been rigorously examined, but there is no clear signal for a significant potential for harm.

Trajectories of response to acupuncture for menopausal vasomotor symptoms: the Acupuncture in Menopause study.

OBJECTIVE: To examine the trajectories of responses to acupuncture treatment for menopausal vasomotor symptoms (VMS) and the characteristics of women in each trajectory. METHODS: Two hundred nine perimenopausal and postmenopausal women aged 45 to 60 years experiencing at least four VMS per day were recruited and randomized to receive up to 20 acupuncture treatments within 6 months or to a waitlist control group. The primary outcome was percent change from baseline in the mean daily VMS frequency. Finite mixture modeling was used to identify patterns of percent change in weekly VMS frequencies over the first 8 weeks. The Freeman-Holton test and analysis of variance were used to compare characteristics of women in different trajectories. RESULTS: Analyses revealed four distinct trajectories of change in VMS frequency by week 8 in the acupuncture group. A small group of women (11.6%, n = 19) had an 85% reduction in VMS. The largest group (47%, n = 79) reported a 47% reduction in VMS frequency, 37.3% (n = 65) of the sample showed only a 9.6% reduction in VMS frequency, and a very small group (4.1%, n = 7) had a 100% increase in VMS. Among women in the waitlist control group, 79.5% reported a 10% decrease in VMS frequency at week 8. Baseline number of VMS, number of acupuncture treatments in the first 8 weeks, and traditional Chinese medicine diagnosis were significantly related to trajectory group membership in the acupuncture group. CONCLUSIONS: Approximately half of the treated sample reported a decline in VMS frequency, but identifying clear predictors of clinical response to acupuncture treatment of menopausal VMS remains challenging.

Role of Acupuncture in the Treatment or Prevention of Migraine, Tension-Type Headache, or Chronic Headache Disorders.

OBJECTIVE: To summarize the current evidence that evaluates the effectiveness of acupuncture for the treatment or prevention of migraine, tension-type headache, and chronic headache disorders. METHODS: Findings from selected systematic reviews and meta-analyses are summarized. RESULTS: Recently published systematic reviews and meta-analyses demonstrate that acupuncture is associated with improved clinical outcomes compared to routine care only, medical management, and sham acupuncture 2 months after randomization. The evidence in support of acupuncture's comparative effectiveness at longer follow-up periods is mixed. Cost effectiveness analyses conducted in the United Kingdom and Germany suggest that acupuncture is a cost-effective treatment option in those countries. There are few or no cost-effectiveness studies of acupuncture in the United States. DISCUSSION: This brief review of the current, published evidence does not include a discussion of potential risks or adverse events associated with acupuncture. There is also the question of the extent to which placebo effects might contribute to acupuncture's clinical effectiveness. From a purely comparative effectiveness perspective, however, the evidence from clinical trials and meta-analyses makes a compelling case in support of a potentially important role for acupuncture as part of a treatment plan for patients with migraine, tension-type headache, and several different types of chronic headache disorders.

Nonpharmacologic, nonherbal management of menopause-associated vasomotor symptoms: an umbrella systematic review (protocol).

BACKGROUND: Vasomotor symptoms such as hot flashes and night sweats are a common concern of perimenopausal and postmenopausal women and are associated with a decreased quality of life. These symptoms can be effectively managed with hormone therapy, but safety concerns limit its use. Thus, understanding the effectiveness of nonpharmacologic therapies such as acupuncture or yoga is critical to managing these common symptoms in older women. Our review seeks to address the following question: In women with menopause-associated vasomotor symptoms, what are the effects on health-related quality of life, vasomotor symptoms, and adverse events of the following nonpharmacologic, nonherbal interventions as compared with any inactive control or active comparator: (a) acupuncture, (b) yoga, tai chi, and qigong, (c) structured exercise, and (d) meditation, mindfulness-based practices, and relaxation? METHODS: We describe a protocol for an umbrella review approach, supplemented by evaluating randomized controlled trials (RCTs) published after the most recent good-quality systematic review for each of the eligible interventions. Specific interventions were chosen based on current literature and with input from a technical expert panel and organizational stakeholders. We will conduct a thorough literature search and perform a quality assessment of potentially included systematic reviews and RCTs. DISCUSSION: Our umbrella review, supplemented by an additional search for eligible RCTs, aims to synthesize existing evidence on the use of nonpharmacologic, nonherbal interventions to manage bothersome vasomotor symptoms in perimenopausal and postmenopausal women. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42016029335.

An evidence map of yoga for low back pain.

OBJECTIVE: Yoga is being increasingly studied as a treatment strategy for a variety of different clinical conditions, including low back pain (LBP). We set out to conduct an evidence map of yoga for the treatment, prevention and recurrence of acute or chronic low back pain (cLBP). METHODS: We searched Medline, Cochrane Database of Systematic Reviews, EMBASE, Allied and Complementary Medicine Database and ClinicalTrials.gov for randomized controlled trials (RCT), systematic reviews or planned studies on the treatment or prevention of acute back pain or cLBP. Two independent reviewers screened papers for inclusion, extracted data and assessed the quality of included studies. RESULTS: Three eligible systematic reviews were identified that included 10 RCTs (n=956) that evaluated yoga for non-specific cLBP. We did not identify additional RCTs beyond those included in the systematic reviews. Our search of ClinicalTrials.gov identified one small (n=10) unpublished trial and one large (n=320) planned clinical trial. The most recent good quality systematic review indicated significant effects for short- and long-term pain reduction (n=6 trials; standardized mean difference [SMD] -0.48; 95% CI, -0.65 to -0.31; I(2)=0% and n=5; SMD -0.33; 95% CI, -0.59 to -0.07; I(2)=48%, respectively). Long-term effects for back specific disability were also identified (n=5; SMD -0.35; 95% CI, -0.55 to -0.15; I(2)=20%). No studies were identified evaluating yoga for prevention or treatment of acute LBP. CONCLUSION: Evidence suggests benefit of yoga in midlife adults with non-specific cLBP for short- and long-term pain and back-specific disability, but the effects of yoga for health-related quality of life, well- being and acute LBP are uncertain. Without additional studies, further systematic reviews are unlikely to be informative.

Acupuncture in Menopause (AIM) study: a pragmatic, randomized controlled trial.

OBJECTIVE: The aim of the study was to evaluate the short and long-term effects of acupuncture on vasomotor symptoms (VMS) and quality of life-related measures. METHODS: A total of 209 perimenopausal and postmenopausal women aged 45 to 60 years, experiencing four or more VMS per day, were recruited from the community and randomized to receive up to 20 acupuncture treatments within the first 6 months (acupuncture group) or the second 6 months (waitlist control group) of the 12-month study period. The primary outcome was mean daily frequency of VMS. Secondary outcomes were VMS interference with daily life, sleep quality, depressive symptoms, somatic and other symptoms, anxiety, and quality of life. RESULTS: The VMS frequency declined by 36.7% at 6 months in the acupuncture group and increased by 6.0% in the control group (P < 0.001 for between-group comparison). At 12 months, the reduction from baseline in the acupuncture group was 29.4% (P < 0.001 for within-group comparison from baseline to 12 months), suggesting that the reduction was largely maintained after treatment. Statistically significant clinical improvement was observed after three acupuncture treatments, and maximal clinical effects occurred after a median of eight treatments. Persistent improvements were seen in many quality of life-related outcomes in the acupuncture group relative to the control group. CONCLUSIONS: We found that a course of acupuncture treatments was associated with significant reduction in VMS, and several quality-of-life measures, compared with no acupuncture, and that clinical benefit persisted for at least 6 months beyond the end of treatment.

Unanticipated Insights into Biomedicine from the Study of Acupuncture.

Research into acupuncture has had ripple effects beyond the field of acupuncture. This paper identifies five exemplars to illustrate that there is tangible evidence of the way insights gleaned from acupuncture research have informed biomedical research, practice, or policy. The first exemplar documents how early research into acupuncture analgesia has expanded into neuroimaging research, broadening physiologic understanding and treatment of chronic pain. The second describes how the acupuncture needle has become a tool to enhance biomedical knowledge of connective tissue. The third exemplar, which illustrates use of a modified acupuncture needle as a sham device, focuses on emergent understanding of placebo effects and, in turn, on insights into therapeutic encounters in treatments unrelated to acupuncture. The fourth exemplar documents that two medical devices now in widespread use were inspired by acupuncture: transcutaneous electrical nerve stimulators for pain control and antinausea wrist bands. The final exemplar describes how pragmatic clinical trial designs applied in acupuncture research have informed current general interest in comparative effectiveness research. In conclusion, these exemplars of unanticipated outcomes of acupuncture research comprise an additional rationale for continued support of basic and clinical research evaluating acupuncture and other under-researched therapies.

Evidence Map of Yoga for Depression, Anxiety, and Posttraumatic Stress Disorder.

BACKGROUND: This study describes evidence of yoga's effectiveness for depressive disorders, general anxiety disorder (GAD), panic disorder (PD), and posttraumatic stress disorder (PTSD) in adults. We also address adverse events associated with yoga. METHODS: We searched multiple electronic databases for systematic reviews (SRs) published between 2008 and July 2014, randomized controlled trials (RCTs) not identified in eligible SRs, and ongoing RCTs registered with ClincalTrials.gov. RESULTS: We identified 1 SR on depression, 1 for adverse events, and 3 addressing multiple conditions. The high-quality depression SR included 12 RCTs (n = 619) that showed improved short-term depressive symptoms (standardized mean difference, -0.69, 95% confidence interval, -0.99 to -0.39), but there was substantial variability (I2 = 86%) and a high risk of bias for 9 studies. Three SRs addressing multiple conditions identified 4 nonrandomized studies (n = 174) for GAD/PD and 1 RCT (n = 8) and 2 nonrandomized studies (n = 22) for PTSD. We separately found 1 RCT (n = 13) for GAD and 2 RCTs (n = 102) for PTSD. Collectively, these studies were inconclusive for the effectiveness of yoga in treating GAD/PD and PTSD. The high-quality SR for adverse events included 37 primary reports (n = 76) in which inversion postures were most often implicated. We found 5 ongoing trials (3 for PTSD). CONCLUSIONS: Yoga may improve short-term depressive symptoms, but evidence for GAD, PD, and PTSD remain inconclusive.

Effectiveness of Exercise Programs for Management of Shoulder Pain in Manual Wheelchair Users With Spinal Cord Injury.

BACKGROUND AND PURPOSE: Shoulder pain is prevalent in manual wheelchair users (MWUs) with spinal cord injury (SCI). Therapeutic exercise has been demonstrated to be an effective, conservative approach to treating shoulder pain in able-bodied individuals. We sought to evaluate literature on the effectiveness of exercise programs on the reduction of shoulder pain in MWUs with SCI. METHODS: We searched the literature, using search terms related to SCI, manual wheelchairs, and shoulder pain. Eligibility criteria included prospective study design, exercise intervention for MWUs with shoulder pain, and use of the Wheelchair User's Shoulder Pain Index as an outcome measure. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and assessed study quality. RESULTS: Three randomized control trials and 4 cohort studies met inclusion criteria. Two studies were rated as good quality and 5 as fair quality. Three interventions were evaluated in the included studies: arm ergometry, resistive strengthening with or without electromyographic biofeedback, and stretching that targeted the muscles of the shoulder girdle. Across the 7 studies, the exercise intervention was associated with reduction in shoulder pain that exceeded the estimated minimal detectable change of 5.10 points for the Wheelchair Users' Shoulder Pain Index. DISCUSSION AND CONCLUSION: Exercise is a feasible, conservative, therapeutic intervention for the treatment of shoulder pain among MWUs. Additional studies are needed to differentiate techniques for the reduction of shoulder pain, to determine the most effective duration of intervention, and to estimate the magnitude of effect associated with therapeutic exercise for shoulder pain among MWUs.Video Abstract available for more insights from the authors (see Supplemental Digital Content 1, http://links.lww.com/JNPT/A116).

Future Research Prioritization: Implantable Cardioverter-Defibrillator Therapy in Older Patients.

BACKGROUND: Although the implantable cardioverter-defibrillator (ICD) is highly effective therapy for preventing sudden cardiac death, there is considerable uncertainty about its benefits and harms in older patients, especially in the presence of factors, other than old age, that increase the risk of death. OBJECTIVE: To develop a prioritized research agenda for the Patient-Centered Outcomes Research Institute as informed by a diverse group of stakeholders on the use and outcomes of the ICD in older patients. DESIGN: The existing literature was reviewed to identify evidence gaps, which were then refined by engaged stakeholders. Using a forced-ranking prioritization method, the stakeholders ranked evidence gaps by importance. For the highest-ranked evidence gaps, relevant recent studies were identified using PubMed, and relevant ongoing trials were identified using ClinicalTrials.gov. PARTICIPANTS: Eighteen stakeholders, including clinical experts and researchers in the prevention of sudden cardiac death and ICD therapy, representatives from federal and non-governmental funding agencies, representatives from relevant professional societies, health care decision-makers and policymakers, and representatives from related consumer and patient advocacy groups KEY RESULTS: The top 12 evidence gaps prioritized by stakeholders were related to the safety and effectiveness of ICDs in older patient subgroups not well represented in clinical trials, predictors of SCD, the impact of the ICD on quality of life, the use of shared decision-making, disparities in ICD use, risk stratification strategies, patient preferences, and distribution of modes of death in older patients. CONCLUSIONS: In this paper, we identify evidence gaps of high priority for current and future investigations of ICD therapy. Addressing these gaps will likely resolve many of the uncertainties surrounding the use and outcomes of the ICD in older patients seen in clinical practice.

Tools for assessing outcomes in studies of chronic cough: CHEST guideline and expert panel report.

BACKGROUND: Since the publication of the 2006 American College of Chest Physicians (CHEST) cough guidelines, a variety of tools has been developed or further refined for assessing cough. The purpose of the present committee was to evaluate instruments used by investigators performing clinical research on chronic cough. The specific aims were to (1) assess the performance of tools designed to measure cough frequency, severity, and impact in adults, adolescents, and children with chronic cough and (2) make recommendations or suggestions related to these findings. METHODS: By following the CHEST methodologic guidelines, the CHEST Expert Cough Panel based its recommendations and suggestions on a recently published comparative effectiveness review commissioned by the US Agency for Healthcare Research and Quality, a corresponding summary published in CHEST, and an updated systematic review through November 2013. Recommendations or suggestions based on these data were discussed, graded, and voted on during a meeting of the Expert Cough Panel. RESULTS: We recommend for adults, adolescents (≥ 14 years of age), and children complaining of chronic cough that validated and reliable health-related quality-of-life (QoL) questionnaires be used as the measurement of choice to assess the impact of cough, such as the Leicester Cough Questionnaire and the Cough-Specific Quality-of-Life Questionnaire in adult and adolescent patients and the Parent Cough-Specific Quality of Life Questionnaire in children. We recommend acoustic cough counting to assess cough frequency but not cough severity. Limited data exist regarding the performance of visual analog scales, numeric rating scales, and tussigenic challenges. CONCLUSIONS: Validated and reliable cough-specific health-related QoL questionnaires are recommended as the measurement of choice to assess the impact of cough on patients. How they compare is yet to be determined. When used, the reporting of cough severity by visual analog or numeric rating scales should be standardized. Previously validated QoL questionnaires or other cough assessments should not be modified unless the new version has been shown to be reliable and valid. Finally, in research settings, tussigenic challenges play a role in understanding mechanisms of cough.