Systematic review and meta-analysis of endovascular and surgical revascularization for patients with chronic lower extremity venous insufficiency and varicose veins.

BACKGROUND: Chronic lower extremity venous disease (LECVD) is twice as prevalent as coronary heart disease, and invasive therapies to treat LECVD accounted for an estimated $290 million in Medicare expenditures in 2015. Despite increasing use of these invasive therapies, their comparative effectiveness is unknown. METHODS: We conducted a systematic review and meta-analysis of treatments for patients (symptomatic and asymptomatic) with lower extremity varicosities and/or lower extremity chronic venous insufficiency/incompetence/reflux. We searched PubMed, Embase, and the Cochrane Database of Systematic Reviews for relevant English-language studies published from January 2000 to July 2016. We included comparative randomized controlled trials (RCTs) with >20 patients and observational studies with >500 patients. Short-, intermediate-, and long-term outcomes of placebo, mechanical compression therapy, and invasive therapies (surgical and endovascular) were included. Quality ratings and evidence grading was performed. Random-effects models were used to compute summary estimates of effects. RESULTS: We identified a total of 57 studies representing 105,878 enrolled patients, including 53 RCTs comprised of 10,034 patients. Among the RCTs, 16 were good quality, 28 were fair quality, and 9 were poor quality. Allocation concealment, double blinding, and reporting bias were inadequately addressed in 25 of 53 (47%), 46 of 53 (87%), and 15 of 53 (28.3%), respectively. Heterogeneity in therapies, populations, and/or outcomes prohibited meta-analysis of comparisons between different endovascular therapies and between endovascular intervention and placebo/compression. Meta-analysis evaluating venous stripping plus ligation (high ligation/stripping) compared with radiofrequency ablation revealed no difference in short-term bleeding (odds ratio [OR]=0.30, 95% CI -0.16 to 5.38, P=.43) or reflux recurrence at 1-2 years (OR=0.76, 95% CI 0.37-1.55, P=.44). Meta-analysis evaluating high ligation/stripping versus endovascular laser ablation revealed no difference in long-term symptom score (OR 0.02, 95% CI -0.19 to 0.23, P=.84) or quality of life at 2 years (OR 0.06, 95% CI -0.12 to 0.25, P=.50). CONCLUSIONS: The paucity of high-quality comparative effectiveness and safety data in LECVD is concerning given the overall rise in endovascular procedures. More high-quality studies are needed to determine comparative effectiveness and guide policy and practice.

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.

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.

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.

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).

Prioritization of patient-centered comparative effectiveness research for osteoarthritis.

Osteoarthritis is a leading cause of disability in the United States. This article describes a prioritized research agenda about osteoarthritis management developed for the Patient-Centered Outcomes Research Institute. Evidence gaps were identified by reviewing existing literature and engaging diverse stakeholders to expand and refine gaps. Stakeholders ranked evidence gaps by importance from their perspectives.Prioritized evidence gaps included the need to determine or evaluate key patient-centered outcomes; optimal duration, intensity, and frequency of nonsurgical interventions; whether the comparative effectiveness of nonsurgical interventions varies by socioeconomic factors; when and how to transition from nonsurgical to surgical interventions; effective ways to engage patients in self-management and promote long-term behavior change; standardized screening tools that improve early diagnosis; biomechanical strategies that improve symptoms; mechanisms for promoting and delivering coordinated, longitudinal care; and comparative effectiveness of nonsurgical therapies. Searches of PubMed and ClinicalTrials.gov showed many recent and ongoing studies addressing comparative effectiveness of nonsurgical interventions; relatively few of these evaluated treatments across categories (for example, drug therapy vs. weight management) or combined categories of treatment. Few studies addressed other high-priority evidence gaps.

Prioritization of research addressing management strategies for ductal carcinoma in situ.

Ductal carcinoma in situ is a common finding in women having mammography screening, and there is considerable uncertainty about the balance of harms and benefits of different management options. This article outlines the process for developing a prioritized research agenda for the Patient-Centered Outcomes Research Institute as informed by a diverse group of stakeholders on the management of ductal carcinoma in situ. Evidence gaps were identified by reviewing existing literature and engaging diverse stakeholders to refine these gaps. Stakeholders ranked evidence gaps by importance from their perspectives using a forced-ranking prioritization method. PubMed was searched for relevant recent studies, and ClinicalTrials.gov was searched for relevant ongoing trials for the 10 highest-ranked evidence gaps. Strengths and limitations of different study designs were assessed to address gaps. Stakeholders prioritized evidence gaps related to incorporation of patient-centered outcomes into future research, development of better methods to predict risk for invasive cancer, evaluation of a strategy of active surveillance, and testing of decision-making tools. The degree to which prioritized evidence gaps may have already been addressed is uncertain because a comprehensive systematic review has not been done.

Prioritization of research addressing antipsychotics for adolescents and young adults with bipolar disorder.

Despite a paucity of high-quality evidence about benefits and harms, antipsychotic medication use among adolescents and young adults with bipolar disorder is increasing. The Patient-Centered Outcomes Research Institute tasked the Duke Evidence Synthesis Group with creating a prioritized agenda for research in this area that would incorporate the perspectives of relevant stakeholders. We identified a list of potential evidence gaps by reviewing existing literature and engaged a diverse group of 9 stakeholders to expand and refine this list. Using a forced-ranking prioritization method, stakeholders prioritized 10 of 23 potential evidence gaps as the most pressing for future research. These evidence gaps relate to 3 areas: the comparative effectiveness of intervention strategies, the effect of antipsychotics on patient-centered outcomes, and the influence of various patient characteristics on antipsychotic effectiveness. In addition to presenting these findings, we suggest appropriate study designs for addressing the stakeholder-prioritized research questions.

Effect of clinical decision-support systems: a systematic review.

BACKGROUND: Despite increasing emphasis on the role of clinical decision-support systems (CDSSs) for improving care and reducing costs, evidence to support widespread use is lacking. PURPOSE: To evaluate the effect of CDSSs on clinical outcomes, health care processes, workload and efficiency, patient satisfaction, cost, and provider use and implementation. DATA SOURCES: MEDLINE, CINAHL, PsycINFO, and Web of Science through January 2011. STUDY SELECTION: Investigators independently screened reports to identify randomized trials published in English of electronic CDSSs that were implemented in clinical settings; used by providers to aid decision making at the point of care; and reported clinical, health care process, workload, relationship-centered, economic, or provider use outcomes. DATA EXTRACTION: Investigators extracted data about study design, participant characteristics, interventions, outcomes, and quality. DATA SYNTHESIS: 148 randomized, controlled trials were included. A total of 128 (86%) assessed health care process measures, 29 (20%) assessed clinical outcomes, and 22 (15%) measured costs. Both commercially and locally developed CDSSs improved health care process measures related to performing preventive services (n= 25; odds ratio [OR], 1.42 [95% CI, 1.27 to 1.58]), ordering clinical studies (n= 20; OR, 1.72 [CI, 1.47 to 2.00]), and prescribing therapies (n= 46; OR, 1.57 [CI, 1.35 to 1.82]). Few studies measured potential unintended consequences or adverse effects. LIMITATIONS: Studies were heterogeneous in interventions, populations, settings, and outcomes. Publication bias and selective reporting cannot be excluded. CONCLUSION: Both commercially and locally developed CDSSs are effective at improving health care process measures across diverse settings, but evidence for clinical, economic, workload, and efficiency outcomes remains sparse. This review expands knowledge in the field by demonstrating the benefits of CDSSs outside of experienced academic centers. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Transitional care after hospitalization for acute stroke or myocardial infarction: a systematic review.

BACKGROUND: Transitional care is a time-limited service to prevent discontinuous care and adverse outcomes, including rehospitalization. PURPOSE: To describe transitional care interventions and evidence of benefit or harm in patients hospitalized for acute stroke or myocardial infarction (MI). DATA SOURCES: Cumulative Index to Nursing and Allied Health Literature, MEDLINE, Cochrane Database of Systematic Reviews, and EMBASE, supplemented with manual searches of reference lists of relevant studies and review articles (January 2000 to March 2012). STUDY SELECTION: 6 reviewers screened 5857 citations to identify English-language reports of trials or observational studies that compared transitional care with usual care among adults hospitalized for stroke or MI and that reported patient, caregiver, process, or systems outcomes within 1 year of hospital discharge. DATA EXTRACTION: Data on study design, quality, population, intervention characteristics, and patient- and system-level outcomes were extracted by 3 reviewers and confirmed by 1 additional reviewer. DATA SYNTHESIS: 62 articles representing 44 studies of transitional care for either acute stroke (27 studies) or MI (17 studies). Four intervention types were studied: hospital-initiated support (n = 14), patient and family education (n = 7), community-based support (n = 20), and chronic disease management (n = 3). Most studies (68%) were of fair quality. Overall, moderate-strength evidence showed that hospital-initiated support reduced length of stay for patients who had a stroke, and low-strength evidence showed that it reduced mortality for patients who had an MI. Evidence about benefits of other interventions and harms from transitional care services was insufficient. LIMITATIONS: Few studies had high-quality research designs. The usual care comparator was often poorly defined. Applicability to U.S. clinical practice was limited; only 6 studies were conducted in the United States. CONCLUSION: Available evidence shows that hospital-initiated transitional care can improve some outcomes in adults hospitalized for stroke or MI. Finding additional transitional care interventions that improve functional outcomes and prevent rehospitalizations and adverse events is a high priority for the growing population of patients who have an MI or a stroke. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

ECG-based signal analysis technologies for evaluating patients with acute coronary syndrome: a systematic review.

BACKGROUND/OBJECTIVES: Timely identification of cardiac ischemia is critical in patients with acute coronary syndrome (ACS). The first test is often the standard, resting 12-lead ECG. Given its limitations, signal analysis enhancements have been proposed. We summarize the published evidence for commercially available ECG-based signal analysis technologies. METHODS: This is a systematic review of the English-language published literature. RESULTS: Published evidence meeting inclusion criteria was available for two devices: PRIME ECG and LP 3000. Meta-analysis of eight studies estimated a 68.4% sensitivity (95% CI, 35.1%-89.7%) and 91.4% specificity (CI, 83.6%-95.7%) for the PRIME ECG, compared with 40.5% sensitivity (CI, 19.6%-65.5%) and 95.0% specificity (CI, 87.9%-98.0%) for the standard 12-lead ECG. CONCLUSIONS: Existing evidence is insufficient to confidently inform the appropriate use of ECG-based signal analysis technologies for detecting ischemia or infarct in ACS. Further research is needed to determine in what circumstances, if any, these devices might precede, replace, or add to the standard ECG in test strategies for detecting ischemia or infarct in ACS.

Acupuncture for the treatment or management of chronic pain.

Evidence supports the safety and efficacy of acupuncture compared with no treatment, but it is unclear what role the placebo effect plays in acupuncture's efficacy. In determining whether acupuncture is indicated for a given individual or patient population, clinicians should consider acupuncture's effectiveness compared with no acupuncture--as well as the effectiveness, safety, and cost of alternative types of treatment.

Achieving health for a lifetime: a community engagement assessment focusing on school-age children to decrease obesity in Durham, North Carolina.

BACKGROUND: Obesity is a prominent problem in the United States and in North Carolina. One way of combating it is with community-engaged interventions that foster collaboration between health-oriented organizations and community residents. PURPOSE: Our purpose was to assemble a multifaceted group in Durham, North Carolina, to identify factors affecting obesity-related lifestyle behaviors; assess policies, resources, and the population's perception of the problem of obesity; and develop plans to improve health outcomes related to obesity. METHODS: A team consisting of more than 2 dozen partners was assembled to form Achieving Health for a Lifetime (AHL) in order to study and address obesity in the community, initially focusing on elementary school-age children. The team developed a resource guide by collecting information by telephone interviews of provider organizations; geospatial resource maps were created using high-resolution geographic information systems, Duke's Data Support Repository, and county and city records; and focus groups were conducted using the nominal group technique. RESULTS: The AHL team, in collaboration with 2 other teams focused on diabetes and cardiovascular disease, identified 32 resources for diabetes, 20 for obesity, and 13 for cardiovascular disease. Using Geographic Information Systems (GIS), the team identified an area of Durham that had only 1 supermarket, but 34 fast-food restaurants and 84 convenience stores. LIMITATIONS: The focus on particular neighborhoods means that the information obtained might not pertain to all neighborhoods. CONCLUSION: The AHL team was able to assemble a large community partnership in Durham that will allow the members of the community to continue to work toward making residents healthier. Communities facing similar challenges can learn from this experience.

Updated report on comparative effectiveness of ACE inhibitors, ARBs, and direct renin inhibitors for patients with essential hypertension: much more data, little new information.

OBJECTIVES: A 2007 systematic review compared angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) in patients with hypertension. Direct renin inhibitors (DRIs) have since been introduced, and significant new research has been published. We sought to update and expand the 2007 review. DATA SOURCES: We searched MEDLINE and EMBASE (through December 2010) and selected other sources for relevant English-language trials. STUDY ELIGIBILITY CRITERIA, PARTICIPANTS, AND INTERVENTIONS: We included studies that directly compared ACE inhibitors, ARBs, and/or DRIs in at least 20 total adults with essential hypertension; had at least 12 weeks of follow-up; and reported at least one outcome of interest. Ninety-seven (97) studies (36 new since 2007) directly comparing ACE inhibitors versus ARBs and three studies directly comparing DRIs to ACE inhibitor inhibitors or ARBs were included. STUDY APPRAISAL AND SYNTHESIS METHODS: A standard protocol was used to extract data on study design, interventions, population characteristics, and outcomes; evaluate study quality; and summarize the evidence. RESULTS: In spite of substantial new evidence, none of the conclusions from the 2007 review changed. The level of evidence remains high for equivalence between ACE inhibitors and ARBs for blood pressure lowering and use as single antihypertensive agents, as well as for superiority of ARBs for short-term adverse events (primarily cough). However, the new evidence was insufficient on long-term cardiovascular outcomes, quality of life, progression of renal disease, medication adherence or persistence, rates of angioedema, and differences in key patient subgroups. LIMITATIONS: Included studies were limited by follow-up duration, protocol heterogeneity, and infrequent reporting on patient subgroups. CONCLUSIONS AND IMPLICATIONS OF KEY FINDINGS: Evidence does not support a meaningful difference between ACE inhibitors and ARBs for any outcome except medication side effects. Few, if any, of the questions that were not answered in the 2007 report have been addressed by the 36 new studies. Future research in this area should consider areas of uncertainty and be prioritized accordingly.

Systematic review of disease-modifying antirheumatic drugs for juvenile idiopathic arthritis.

BACKGROUND: Treatment of juvenile idiopathic arthritis (JIA) with disease-modifying antirheumatic drugs (DMARDs) may improve outcomes compared to conventional therapy (e.g., non-steroidal anti-inflammatory drugs, intra-articular corticosteroids). The purpose of this systematic review was to evaluate the comparative effectiveness and safety of DMARDs versus conventional therapy and versus other DMARDs. RESULTS: A systematic evidence review of 156 reports identified in MEDLINE®, EMBASE®, and by hand searches. There is some evidence that methotrexate is superior to conventional therapy. Among children who have responded to a biologic DMARD, randomized discontinuation trials suggest that continued treatment decreases the risk of having a flare. However, these studies evaluated DMARDs with different mechanisms of action (abatacept, adalimumab, anakinra, etanercept, intravenous immunoglobulin, tocilizumab) and used varying comparators and follow-up periods. Rates of serious adverse events are similar between DMARDs and placebo in published trials. This review identified 11 incident cases of cancer among several thousand children treated with one or more DMARD. CONCLUSIONS: Few data are available to evaluate the comparative effectiveness of either specific DMARDs or general classes of DMARDs. However, based on the overall number, quality, and consistency of studies, there is moderate strength of evidence to support that DMARDs improve JIA-associated symptoms. Limited data suggest that short-term risk of cancer is low.

Results of a pilot study of a cooling mattress pad to reduce vasomotor symptoms and improve sleep.

OBJECTIVE: This single-arm pilot study was designed to generate pilot data on the use of a cooling mattress pad system on vasomotor symptoms (VMS; hot flashes and/or night sweats), self-assessed sleep, and daily hot flash interference among perimenopausal and postmenopausal women. METHODS: A total of 15 perimenopausal and postmenopausal women aged 45 to 59 years experiencing four or more VMS per day were recruited from the community. After completion of baseline questionnaires and a 2-week daily diary to confirm VMS eligibility, all women received a cooling mattress pad system to use at night for 8 weeks, during which time they continued to complete their daily diaries to record VMS frequency and severity. The primary study outcome was change from baseline in VMS frequency. Secondary outcomes were sleep quality, measured by the Pittsburgh Sleep Quality Index, and hot flash interference with daily life, assessed by the Hot Flash Related Daily Interference Scale, where higher sores indicate worse sleep quality and higher interference, respectively. We used repeated-measures methods (analysis of covariance, paired t tests, and McNemar test) to evaluate outcomes. RESULTS: VMS frequency significantly declined by 52% at 8 weeks ( P < 0.0001). Mean total Pittsburgh Sleep Quality Index score significantly declined 3.27 points from 11.14 at baseline to 7.87 at follow-up ( P = 0.011). The total Hot Flash Related Daily Interference Scale score significantly declined from 4.16 at baseline to 1.92 at follow-up ( P = 0.011). CONCLUSIONS: Women who used a cooling mattress pad system experienced significant and clinically meaningful reductions in VMS frequency, sleep disturbance, and hot flash interference with daily activities over an 8-week period. These results provide preliminary evidence suggesting that a cooling mattress pad used while sleeping can provide a nonpharmacological option to reduce VMS and sleep disturbance for women experiencing menopausal hot flashes.

Percutaneous heart valve replacement for aortic stenosis: state of the evidence.

Surgical aortic valve replacement (SAVR) is the only treatment known to improve symptoms and survival in patients with severe, symptomatic aortic stenosis. Perioperative mortality, however, is high among many patients for whom SAVR may be indicated. Percutaneous heart valve replacement (PHVR) is an emerging, catheter-based technology that allows for implantation of a prosthetic valve without open heart surgery. This review describes the available literature on PHVR for aortic stenosis, which comprised 84 published reports representing 76 distinct studies and 2375 unique patients. Successful implantation was achieved in 94% of patients; 30-day survival was 89%. Differences between patients undergoing PHVR and those typically selected for SAVR make full interpretation of these results difficult. A large, multicenter, randomized, controlled trial comparing PHVR with SAVR or medical management was recently completed, with initial results expected in September 2010. Pending publication of findings from that trial, the available evidence is inadequate to determine the most appropriate clinical role of PHVR or the specific patient populations for whom it might eventually be indicated.

Incorporating Acupuncture Into American Healthcare: Initiating a Discussion on Implementation Science, the Status of the Field, and Stakeholder Considerations.

INTRODUCTION: The field of implementation science is the study of methods that promote the uptake of evidence-based interventions into healthcare policy and practice. While acupuncture has gained significant traction in the American healthcare landscape, its journey has been somewhat haphazard and non-linear. METHODS: In June 2019, a group of thirty diverse stakeholders was convened by the Society for Acupuncture Research with the support of a Patient Centered Outcomes Research Institute, Eugene Washington Engagement Award. This group of stakeholders represented a diverse mix of patients, providers, academicians, researchers, funders, allied health professionals, insurers, association leaders, certification experts, and military program developers. The collective engaged in discussion that explored acupuncture's status in healthcare, including reflections on its safety, effectiveness, best practices, and the actual implementation of acupuncture as seen from diverse stakeholder viewpoints. OBJECTIVES: A primary goal was to consider how to utilize knowledge from the field of implementation science more systematically and intentionally to disseminate information about acupuncture and its research base, through application of methods known to implementation science. The group also considered novel challenges that acupuncture may present to known implementation processes. FINDINGS: This article summarizes the initial findings of this in-person meeting of stakeholders and the ongoing discussion among the subject matter experts who authored this report. The goal of this report is to catalyze greater conversation about how the field of implementation science might intersect with practice, access, research, and policymaking pertaining to acupuncture. Core concepts of implementation science and its relationship to acupuncture are introduced, and the case for acupuncture as an Evidence Based Practice (EBP) is established. The status of the field and current environment of acupuncture is examined, and the perspectives of four stakeholder groups--patients, two types of professional practitioners, and researchers--are explored in more detail.