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This article summarizes the Parkinson's Disease (PD) Endpoints Roundtable, which was held in Washington, D.C., on November 2-3, 2022, and hosted by The Michael J. Fox Foundation for Parkinson's Research, Parkinson's UK, and Parkinson Canada. This event brought representatives from academia and industry together with those from regulatory agencies, community partners, and research funders to discuss challenges in clinical outcome assessment development for treatments in early PD and to identify priorities for the field and opportunities for collaboration. This article provides a summary of the presentations given and topics discussed at the roundtable and synthesizes the discussions about the development of clinical outcome assessments and the use of digital health technologies for developing clinical trial endpoints., (Copyright © 2024 RAND Corporation.)

Background: Acupuncture and chiropractic care are evidence-based pain management alternatives to opioids. The Veterans Health Administration (VA) provides this care in some VA facilities, but also refers patients to community providers. We aimed to determine if patient-reported outcomes differ for acupuncture and chiropractic care from VA versus community providers., Materials and Methods: We conducted an observational study using survey outcome data and electronic medical record utilization data for acupuncture and chiropractic care provided in 18 VA facilities or in community facilities reimbursed by VA. Study participants were users of VA primary care, mental health, pain clinic, complementary and integrative therapies, coaching or education services in 2018-2019. Patients received 1) 4+ acupuncture visits (N = 201) or 4+ chiropractic care visits (N = 178) from a VA or community provider from 60 days prior to baseline to six-months survey and 2) no acupuncture or chiropractic visits from 1 year to 60 days prior to baseline. Outcomes measured included patient-reported pain (PEG) and physical health (PROMIS) at baseline and six-month surveys. Multivariate analyses examined outcomes at six months, adjusting for baseline outcomes and demographics., Results: In unadjusted analyses, pain and physical health improved for patients receiving community-based acupuncture, while VA-based acupuncture patients experienced no change. Unadjusted analyses also showed improvements in physical health, but not pain, for patients receiving VA-based chiropractic care, with no changes for community-based chiropractic care patients. Using multivariate models, VA-based acupuncture was no different from community-based acupuncture for pain (-0.258, p = 0.172) or physical health (0.539, p = 0.399). Similarly, there were no differences between VA- and community-based chiropractic care in pain (-0.273, p = 0.154) or physical health (0.793, p = 0.191)., Conclusions: Acupuncture and chiropractic care were associated with modest improvements at six months, with no meaningful differences between VA and community providers. The choice to receive care from VA or community providers could be based on factors other than quality, like cost or convenience., Competing Interests: The authors have declared that no competing interests exist., (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)

Background: Interpersonal communication is a cornerstone of patient-centered care. We aimed to identify what patients with cancer and caregivers may want from communication during a public health crisis., Methods: We interviewed 15 patients (8 Veteran, 7 non-Veteran) and caregivers from regionally, racially, and ethnically diverse backgrounds across the US about serious illness care and quality of care during the COVID-19 pandemic Using an iterative, inductive and deductive process, 2 coders analyzed content associated with the code "Communication," which appeared 71 times, and identified 5 themes., Results: Participants identified as White (10), Latino/a (3), Asian (1), and Black (1). (1) Help patients and caregivers prepare for care during crisis by communicating medical information directly and proactively. (2) Explain how a crisis might influence medical recommendations and impact on recovery from illness. (3) Use key messengers to improve communication between primary teams, patients, and caregivers. (4) Include caregivers and families in communication when they cannot be physically present. (5) Foster bidirectional communication with patients and families to engage them in shared decision-making during a vulnerable time., Conclusion: Communication is critical during a public health crisis yet overwhelmed clinicians may not be able to communicate effectively. Communicating with caregivers and family, transparent and timely communication, ensuring diverse providers are on the same page, and effective listening are known gaps even before the COVID-19 pandemic. Clinicians may need quick interventions, like education about goals of care, to remind them about what seriously ill patients and their caregivers want from communication and offer patient-centered care during crises., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Patients with cancer, especially advanced cancer, experience depression at high rates. We aimed to evaluate the quality of depression care received by patients with solid tumor cancer and advanced solid tumor cancer in Veterans Affairs (VA) primary care clinics. This is a retrospective cohort study of patients seen in 82 VA primary care clinics who newly screened positive for depression on the Patient Health Questionnaire (PHQ-2). Outcomes included timely follow-up within 84 or 180 days (3+ mental health specialty, 3+ psychotherapy, or 3+ primary care visits with depression diagnosis codes) and minimum treatment within 1 year (60+ days antidepressants prescribed, 4+ mental health specialty visits, or 3+ psychotherapy visits). 608,042 individuals were seen in VA primary care clinics during this period; 49,839 patients (8.2%) had solid tumor cancer and 9,278 (1.5%) had advanced or poor-prognosis solid tumor cancer. For 686 observations of patients with cancer and new depression, rates of appropriate follow-up were 22.3% within 84 days and 38.2% within 180 days. For 73 observations of patients with advanced or poor-prognosis cancer and new depression, rates of appropriate follow-up were 21.9% within 84 days and 34.3% within 180 days. Rates of minimum treatment within 1 year were 68.4% and 64.4% for patients with cancer and patients with advanced or poor-prognosis cancer, respectively. Quality of timely depression management is low in patients with solid tumor cancers. Even in health systems with well-integrated mental health services, care gaps remain for patients with cancer and depression. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Quality measurement is typically the domain of clinical experts and health system leaders; patient/caregiver perspectives are rarely solicited. We aimed to describe and integrate clinician and patient/caregiver conceptualizations of high-quality palliative symptom care for patients receiving care for advanced cancer within the US Veterans Health Administration in the context of existing quality measures. We conducted a secondary qualitative analysis of transcripts from prioritization discussions of process quality measures relevant to cancer palliative care. These discussions occurred during 2 modified RAND-UCLA appropriateness panels: a panel of 10 palliative care clinical expert stakeholders (7 physicians, 2 nurses, 1 social worker) and a panel of 9 patients/caregivers with cancer experience. Discussions were recorded, transcribed, and independently double-coded using an a priori logical framework. Content analysis was used to identify subthemes within codes and axial coding was used to identify crosscutting themes. Patients/caregivers and clinical experts contributed important perspectives to 3 crosscutting themes. First, proactive elicitation of symptoms is critical. Patients/caregivers especially emphasized importance of comprehensive and proactive screening and assessment, especially for pain and mental health. Second, screening and assessment alone is not enough; information elicited from patients must inform care. Measuring screening/assessment and management care processes separately has important limitations. Lastly, high-quality symptom management can be broadly defined if it is patient-centered; high-quality care takes an individualized approach and might include non-medical or non-pharmacological symptom management. Integrating the perspectives of clinical experts and patients/caregivers is critical for health systems to consider as they design and implement quality measures for palliative cancer care.

Background: Development and prioritization of quality measures typically relies on experts in clinical medicine, but patients and their caregivers may have different perspectives on quality measurement priorities., Objective: To inform priorities for health system implementation of palliative cancer and end-of-life care quality measures by eliciting perspectives of patients and caregivers., Design: Using modified RAND-UCLA Appropriateness Panel methods and materials tailored for knowledgeable lay participants, we convened a panel to rate cancer palliative care process quality measure concepts before and after a 1-day, in-person meeting., Participants: Nine patients and caregivers with experience living with or caring for patients with cancer., Main Measures: Panelists rated each concept on importance for providing patient- and family-centered care on a nine-point scale and each panelist nominated five highest priority measure concepts ("top 5")., Key Results: Cancer patient and caregiver panelists rated all measure concepts presented as highly important to patient- and family- centered care (median rating ≥ 7) in pre-panel (mean rating range, 6.9-8.8) and post-panel ratings (mean rating range, 7.2-8.9). Forced choice nominations of the "top 5" helped distinguish similarly rated measure concepts. Measure concepts nominated into the "top 5" by three or more panelists included two measure concepts of communication (goals of care discussions and discussion of prognosis), one measure concept on providing comprehensive assessments of patients, and three on symptoms including pain management plans, improvement in pain, and depression management plans. Patients and caregivers nominated one additional measure concept (pain screening) back into consideration, bringing the total number of measure concepts under consideration to 21., Conclusions: Input from cancer patients and caregivers helped identify quality measurement priorities for health system implementation. Forced choice nominations were useful to discriminate concepts with the highest perceived importance. Our approach serves as a model for incorporating patient and caregiver priorities in quality measure development and implementation., (© 2021. This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.)

Objective: The quality of care provided by the US Department of Veterans Affairs (VA) is increasingly being compared to community providers. The objective of this study was to compare the VA Community Living Centers (CLCs) to nursing homes in the community (NHs) in terms of characteristics of their post-acute populations and performance on 3 claims-based ("short-stay") quality measures., Design: Observational, cross-sectional., Setting and Participants: CLC and NH residents admitted from hospitals during July 2015-June 2016., Methods: CLC residents were compared with 3 NH populations: males, Veterans, and all NH residents. CLC and NH performance was compared on risk-adjusted claims-based measures: unplanned rehospitalizations and emergency department visits within 30 days of CLC or NH admission and successful discharge to the community within 100 days of NH admission., Results: Veterans admitted from hospitals to CLCs (n = 23,839 Veterans/135 CLCs) were less physically impaired, less likely to have anxiety, congestive heart failure, hypertension, and dementia than Veterans (n = 241,177/14,818 NHs), males (n = 661,872/15,280 NHs), and all residents (n = 1,674,578/15,395 NHs) admitted to NHs from hospitals. Emergency department and successful discharge risk-adjusted rates of CLCs were statistically significantly better than those of NHs [mean (standard deviation): 8.3% (4.6%) and 67.7% (11.5%) in CLCs vs 11.9% (5.3%) and 57.0% (10.5%) in NHs, respectively]. CLCs had slightly worse rehospitalization rates [22.5% (6.2%) in CLCs vs 21.1% (5.9%) in NHs], but lower combined emergency department and rehospitalization rates [30.8% (0.8%) in CLCs vs 33.0% (0.7%) in NHs]., Conclusions and Implications: CLCs and NHs serve different post-acute care populations. Using the same risk-adjusted NH quality metrics, CLCs provided better post-acute care than community NHs., (Published by Elsevier Inc.)

Importance: Quality measures of palliative and end-of-life care relevant to patients with advanced cancer have been developed, but few are in routine use. It is unclear which of these measures are most important for providing patient- and family-centered care and have high potential for improving quality of care. Objective: To prioritize process quality measures for assessing delivery of patient- and family-centered palliative and end-of-life cancer care in US Veterans Affairs (VA) health care facilities. Design, Setting, Participants: A panel of 10 palliative and cancer care expert stakeholders (7 physicians, 2 nurses, 1 social worker) rated process quality measure concepts before and after a 1-day meeting. Measures: Panelists rated 64 measure concepts on a nine-point scale on: (1) importance to providing patient- and family-centered care, and (2) potential for quality improvement (QI). Panelists also nominated five highest priority measure concepts ("top 5") on each attribute. Results: Panelists rated most measure concepts (54 premeeting, 56 post-meeting) as highly important to patient- and family-centered care (median rating ≥7). Considerably fewer (17 premeeting, 22 post-meeting) were rated as having high potential for QI. Measure concepts having postpanel median ratings ≥7 and nominated by one or more panelists as "top 5" on either attribute comprised a shortlist of 20 measure concepts. Conclusions: A panel of expert stakeholders helped prioritize 64 measure concepts into a shortlist of 20. Half of the shortlisted measures were related to communication about patient preferences and decision making, and half were related to symptom assessment and treatment.

Purpose: Monitoring and improving the quality of palliative and end-of-life cancer care remain pressing needs in the United States. Among existing measures that assess the quality of palliative and end-of-life care, many operationalize similar concepts. We identified existing palliative care process measures and synthesized these measures to aid stakeholder prioritization that will facilitate health system implementation in patients with advanced cancer., Methods: We reviewed MEDLINE/PubMed-indexed articles for process quality measures related to palliative and end-of-life care for patients with advanced cancer, supplemented by expert input. Measures were inductively grouped into "measure concepts" and higher-level groups., Results: Literature review identified 226 unique measures from 23 measure sources, which we grouped into 64 measure concepts within 12 groups. Groups were advance care planning (11 measure concepts), pain (7), dyspnea (9), palliative care-specific issues (6), other specific symptoms (17), comprehensive assessment (2), symptom assessment (1), hospice/palliative care referral (1), spiritual care (2), mental health (5), information provision (2), and culturally appropriate care (1)., Conclusion: Measure concepts covered the spectrum of care from acute symptom management to advance care planning and psychosocial needs, with variability in the number of measure concepts per group. This taxonomy of process quality measure concepts can be used by health systems seeking stakeholder input to prioritize targets for improving palliative and end-of-life care quality in patients with advanced cancer.

While most studies of health care industry consolidation focus on impacts on prices or quality, these are not its only potential impacts. This exploratory qualitative study describes industry and community stakeholder perceptions of the impacts of cumulative hospital, practice, and insurance mergers, acquisitions, and affiliations in Pittsburgh, Pennsylvania. Since the 1980s, Pittsburgh's health care landscape has been transformed and is now dominated by competition between 2 integrated payer-provider networks, health care system UPMC (and its insurance arm UPMC Health Plan) and insurer Highmark (and its health care system Allegheny Health Network). Semi-structured interviews with 20 boundary-spanning stakeholders revealed a mix of perceived impacts of consolidation: some positive, some neutral or ambiguous, and some negative. Stakeholders perceived consolidation's positive impacts on long-term viability of health care facilities and their ability to adopt new care models, enhanced competition in health insurance, creation of foundations, and pioneering medical research and innovation. Stakeholders also believed that consolidation changed geographic access to care, physician referral behaviors, how educated patients were about their health care, the health care advertising environment, and economies of surrounding neighborhoods. Interviewees noted that consolidation raised questions about what the responsibilities of non-profit organizations are to their communities. However, stakeholders also reported their perceptions of negative outcomes, including ways in which consolidation had potentially reduced patient access to care, accountability and transparency, systems' willingness to collaborate, and physician autonomy. As trends toward consolidation are not slowing, there will be many opportunities to experiment with policy levers to mitigate its potentially negative consequences.

More than 100 rural hospitals have closed since 2010. Some rural hospitals have affiliated with health systems to improve their financial performance and potentially avoid closure, but the effects of affiliation on rural hospitals and their patients are unclear. To examine the relationship between affiliation and performance, we compared rural hospitals that affiliated with a health system in the period 2008-17 and a propensity score-weighted set of nonaffiliating rural hospitals on twelve measures of structure, utilization, financial performance, and quality. Following health system affiliation, rural hospitals experienced a significant reduction in on-site diagnostic imaging technologies, the availability of obstetric and primary care services, and outpatient nonemergency visits, as well as a significant increase in operating margins (by 1.6-3.6 percentage points from a baseline of -1.6 percent). Changes in patient experience scores, readmissions, and emergency department visits were similar for affiliating and nonaffiliating hospitals. While joining health systems may improve rural hospitals' financial performance, affiliation may reduce access to services for patients in rural areas.

Background: Properties of social networks and shared patient networks of physicians are associated with important outcomes, including costs, quality, information exchange, and organizational effectiveness., Objectives: To determine whether practice consolidation affects size, strength, and stability of US practice-based physician shared patient networks., Research Design: We used a dynamic difference-in-differences (event study) design to determine how 2 types of vertical consolidation (hospital and health system practice acquisition) and 2 types of horizontal consolidation (medical group membership and practice-practice mergers) affect individual shared patient network characteristics, controlling for physician fixed effects and geographic market (metropolitan statistical area)., Subjects: Practice-based US physicians whose practices consolidated 2009-2014 are identified via health system, hospital, and medical group affiliation information and appearance/disappearance of listed practice affiliations in the SK&A Physician Database., Measures: Outcomes measured were network size (number of individual physicians with whom a physician shares patients within 30 d), strength (average number of shared patients within those relationships), and stability (percent of shared patient relationships that persist in the current and prior year), all generated from Medicare Shared Patient Patterns (30-d) data., Results: Shared patient network stability increases significantly after acquisition of practices by horizontal practice-practice mergers [βt=1=0.041 (P<0.001), βt=2=0.047 (P<0.001), βt=3=0.041 (P<0.001), βt=4=0.031 (P<0.05), where t is the number of years after the consolidation event]. These effects were robust to sensitivity analyses. Shared patient network size and strength are not observably associated with practice consolidation events., Conclusions: Practice consolidation can increase the stability of physician networks, which may have positive implications for organizational effectiveness.

Introduction: Heart disease kills nearly 300,000 US women annually, while approximately 40,000 US women die of breast cancer. Breast cancer online patient communities are well known for their high engagement and emotional support. This exploratory study compared social media discourse on breast cancer with discourse related to heart disease., Methods: Computer-assisted text analysis of two corpora composed of Twitter posts using #BreastCancer and #HeartDisease hashtags from December 2013 to December 2014. Lexical analysis (word and hashtag level) used AntConc software and lexicogrammatical analysis (style and stance) was conducted with DocuScope., Results: The #BreastCancer corpus consisted of 592,046 posts, 57% of which were not original to the user (retweets). #HeartDisease had 269,769 posts (13% retweets). Social media discourse about #BreastCancer and #HeartDisease drew attention to women, new developments, appeals for help and disease risks. The #BreastCancer corpus incorporates gendered language and associations with art and activism, while posts about #HeartDisease were discussed scientifically in concert with other diseases. The #BreastCancer corpus uniquely included community-specific initialism hashtags. Stance analysis of the #BreastCancer corpus revealed more socially oriented posts, marked by language of constructive reasoning, inclusive language and abstract thought, while #HeartDisease corpus posts were more scholarly, used contingent and oppositional reasoning, language from institutional and academic registers, citations and meta-discourse., Conclusion: The #HeartDisease social media community is less engaged, and content is less specific to both the disease and individual experience than #BreastCancer. Cultivating a women-focused heart disease online community might replicate some of the #BreastCancer community's successes.

Background: Advance care planning (ACP) is fundamental to guiding medical care at the end of life. Understanding the economic impact of ACP is critical to implementation, but most economic evaluations of ACP focus on only a few actors, such as hospitals., Objective: To develop a framework for understanding and quantifying the economic effects of ACP, particularly its distributional consequences, for use in economic evaluations., Design: Literature review of economic analyses of ACP and related costs to estimate magnitude and direction of costs and benefits for each actor and how data on these costs and benefits could be obtained or estimated., Results: ACP can lead to more efficient allocation of resources by reducing low-value care and reallocating resources to high-value care, and can increase welfare by aligning care to patient preferences. This economic framework considers the costs and benefits of ACP that accrue to or are borne by six actors: the patient, the patient's family and caregivers, healthcare providers, acute care settings, subacute and home care settings, and payers. Program implementation costs and nonhealthcare costs, such as time costs borne by patients and caregivers, are included. Findings suggest that out-of-pocket costs for patients and families will likely change if subacute or home care is substituted for acute care, and subacute care utilization is likely to increase while primary healthcare providers and acute care settings may experience heterogeneous effects., Conclusions: A comprehensive economic evaluation of ACP should consider how costs and benefits accrue to different actors.

Purpose: The goal of this study was to assess and compare the potential clinical and economic value of emerging bone-forming agents using the only currently available agent, teriparatide, as a reference case in patients at high, near-term (imminent, 1- to 2-year) risk of osteoporotic fractures, extending to a lifetime horizon with sequenced antiresorptive agents for maintenance treatment., Methods: Analyses were performed by using a Markov cohort model accounting for time-specific fracture protection effects of bone-forming agents followed by antiresorptive treatment with denosumab. The alternative bone-forming agent profiles were defined by using assumptions regarding the onset and total magnitude of protection against fractures with teriparatide. The model cohort comprised 70-year-old female patients with T scores below -2.5 and a previous vertebral fracture. Outcomes included clinical fractures, direct costs, and quality-adjusted life years. The simulated treatment strategies were compared by calculating their incremental "value" (net monetary benefit)., Findings: Improvements in the onset and magnitude of fracture protection (vs the teriparatide reference case) produced a net monetary benefit of $17,000,000 per 10,000 treated patients during the (1.5-year) bone-forming agent treatment period and $80,000,000 over a lifetime horizon that included 3.5 years of maintenance treatment with denosumab., Implications: Incorporating time-specific fracture effects in the Markov cohort model allowed for estimation of a range of cost savings, quality-adjusted life years gained, and clinical fractures avoided at different levels of fracture protection onset and magnitude. Results provide a first estimate of the potential "value" new bone-forming agents (romosozumab and abaloparatide) may confer relative to teriparatide., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Multiple medical organizations recommend using life expectancy (LE) to individualize diabetes care goals. We compare the performance of patient LE predictions made by physicians to LE predictions from a simulation model (the Chicago model) in a cohort of older diabetic patients., Design: Retrospective cohort study of a convenience sample (n = 447) of diabetes patients over 65 years and their physicians. Measurements: Physicians provided LE estimates for individual patients during a baseline survey (2000-2003). The prognostic model included a comprehensive geriatric type 2 diabetes simulation model (the Chicago model) and combinations of the physician estimate and the Chicago model ("And," "Or," and "Average" models). Observed survival was determined based on the National Death Index through 31 December 2010. The predictive accuracy of LE predictions was assessed using c-statistic for 5-year mortality; Harrell's c-statistic, and Integrated Brier score for overall survival. Results: The patient cohort had a mean (SD) age of 73.4 (5.9) years. The majority were female (62.6%) and black (79.4%). At 5 years, 108 (24.2%) patients had died. The c-statistic for 5-year mortality was similar for physicians (0.69) and the Chicago model (0.68), while the average of estimates by physicians and Chicago model yielded the highest c-statistic of any method tested (0.73). The estimates of overall survival yielded a similar pattern of results. Limitations: Generalizability of patient cohort and lack of updated model parameters. Conclusions: Compared with individual methods, the average of LE estimates by physicians and the Chicago model had the best predictive performance. Prognostic models, such as the Chicago model, may complement and support physicians' intuitions as they consider treatment decisions and goals for older patients with chronic conditions like diabetes.

This study compared the Applied Behavior Analysis (ABA) benefit provided by TRICARE as an early intervention for autism spectrum disorder with similar benefits in Medicaid and commercial health insurance plans. The sponsor, the Office of the Under Secretary of Defense for Personnel and Readiness, was particularly interested in how a proposed TRICARE reimbursement rate decrease from $125 per hour to $68 per hour for ABA services performed by a Board Certified Behavior Analyst compared with reimbursement rates (defined as third-party payment to the service provider) in Medicaid and commercial health insurance plans. Information on ABA coverage in state Medicaid programs was collected from Medicaid state waiver databases; subsequently, Medicaid provider reimbursement data were collected from state Medicaid fee schedules. Applied Behavior Analysis provider reimbursement in the commercial health insurance system was estimated using Truven Health MarketScan® data. A weighted mean U.S. reimbursement rate was calculated for several services using cross-state information on the number of children diagnosed with autism spectrum disorder. Locations of potential provider shortages were also identified. Medicaid and commercial insurance reimbursement rates varied considerably across the United States. This project concluded that the proposed $68-per-hour reimbursement rate for services provided by a board certified analyst was more than 25 percent below the U.S. mean.

Background: Alternative strategies exist for diagnosing gout that do not rely solely on the documentation of monosodium urate (MSU) crystals., Purpose: To summarize evidence regarding the accuracy of clinical tests and classification algorithms compared with that of a reference standard of MSU crystals in joint aspirate for diagnosing gout., Data Sources: Several electronic databases from inception to 29 February 2016., Study Selection: 21 prospective cohort, cross-sectional, and case-control studies including participants with joint inflammation and no previous definitive gout diagnosis who had MSU analysis of joint aspirate., Data Extraction: Data extraction and risk-of-bias assessment by 2 reviewers independently; overall strength of evidence (SOE) judgment by group., Data Synthesis: Recently developed algorithms including clinical, laboratory, and imaging criteria demonstrated good sensitivity (up to 88%) and fair to good specificity (up to 96%) for diagnosing gout (moderate SOE). Three studies of dual-energy computed tomography (DECT) showed sensitivities of 85% to 100% and specificities of 83% to 92% for diagnosing gout (low SOE). Six studies of ultrasonography showed sensitivities of 37% to 100% and specificities of 68% to 97%, depending on the ultrasonography signs assessed (pooled sensitivity and specificity for the double contour sign: 74% [95% CI, 52% to 88%] and 88% [CI, 68% to 96%], respectively [low SOE])., Limitation: Important study heterogeneity and selection bias; scant evidence in primary and urgent care settings and in patients with conditions that may be confused with or occur with gout., Conclusion: Multidimensional algorithms, which must be validated in primary and urgent care settings, may help clinicians make a provisional diagnosis of gout. Although DECT and ultrasonography also show promise for gout diagnosis, accessibility to these methods may be limited., Primary Funding Source: Agency for Healthcare Research and Quality. (Protocol registration: https://effectivehealthcare.ahrq.gov/ehc/products/564/1937/gout-protocol-140716.pdf).

Background: Gout is a common type of inflammatory arthritis in patients seen by primary care physicians., Purpose: To review evidence about treatment of acute gout attacks, management of hyperuricemia to prevent attacks, and discontinuation of medications for chronic gout in adults., Data Sources: Multiple electronic databases from January 2010 to March 2016, reference mining, and pharmaceutical manufacturers., Study Selection: Studies of drugs approved by the U.S. Food and Drug Administration and commonly prescribed by primary care physicians, randomized trials for effectiveness, and trials and observational studies for adverse events., Data Extraction: Data extraction was performed by one reviewer and checked by a second reviewer. Study quality was assessed by 2 independent reviewers. Strength-of-evidence assessment was done by group discussion., Data Synthesis: High-strength evidence from 28 trials (only 3 of which were placebo-controlled) shows that colchicine, nonsteroidal anti-inflammatory drugs (NSAIDs), and corticosteroids reduce pain in patients with acute gout. Moderate-strength evidence suggests that low-dose colchicine is as effective as high-dose colchicine and causes fewer gastrointestinal adverse events. Moderate-strength evidence suggests that urate-lowering therapy (allopurinol or febuxostat) reduces long-term risk for acute gout attacks after 1 year or more. High-strength evidence shows that prophylaxis with daily colchicine or NSAIDs reduces the risk for acute gout attacks by at least half in patients starting urate-lowering therapy, and moderate-strength evidence indicates that duration of prophylaxis should be longer than 8 weeks. Although lower urate levels reduce risk for recurrent acute attacks, treatment to a specific target level has not been tested., Limitation: Few studies of acute gout treatments, no placebo-controlled trials of management of hyperuricemia lasting longer than 6 months, and few studies in primary care populations., Conclusion: Colchicine, NSAIDs, and corticosteroids relieve pain in adults with acute gout. Urate-lowering therapy decreases serum urate levels and reduces risk for acute gout attacks., Primary Funding Source: Agency for Healthcare Research and Quality. (Protocol registration: http://effectivehealth-care.ahrq.gov/ehc/products/564/1992/Gout-managment-protocol-141103.pdf).

Background: The prevalence of knee osteoarthritis (OA)/degenerative joint disease (DJD) is increasing in the USA. Systematic reviews of treatment efficacy and adverse events (AEs) of hyaluronic acid (HA) injections report conflicting evidence about the balance of benefits and harms. We review evidence on efficacy and AEs of intraarticular viscosupplementation with HA in older individuals with knee osteoarthritis and account for differences in these conclusions from another systematic review., Methods: We searched PubMed and eight other databases and gray literature sources from 1990 to December 12, 2014. Double-blind placebo-controlled randomized controlled trials (RCTs) reporting functional outcomes or quality-of-life; RCTs and observational studies on delay/avoidance of arthroplasty; RCTs, case reports, and large cohort studies and case series assessing safety; and systematic reviews reporting on knee pain were considered for inclusion. A standardized, pre-defined protocol was applied by two independent reviewers to screen titles and abstracts, review full text, and extract details on study design, interventions, outcomes, and quality. We compared our results with those of a prior systematic review and found them to be discrepant; our analysis of why this discrepancy occurred is the focus of this manuscript., Results: Eighteen RCTs reported functional outcomes: pooled analysis of ten placebo-controlled, blinded trials showed a standardized mean difference of -0.23 (95 % confidence interval (CI) -0.45 to -0.01) favoring HA at 6 months. Studies reported few serious adverse events (SAEs) and no significant differences in non-serious adverse events (NSAEs) (relative risk (RR) [95 % CI] 1.03 [0.93-1.15] or SAEs (RR [95 % CI] 1.39 [0.78-2.47]). A recent prior systematic review reported similar functional outcomes, but significant SAE risk. Differences in SAE inclusion and synthesis accounted for the disparate conclusions., Conclusions: Trials show a small but significant effect of HA on function on which recent systematic reviews agree, but lack of AE synthesis standardization leads to opposite conclusions about the balance of benefits and harms. A limitation of the re-analysis of the prior systematic review is that it required imputation of missing data.

Objectives: To update a prior systematic review on the effects of omega-3 fatty acids (n-3 FA) on maternal and child health and to assess the evidence for their effects on, and associations with, additional outcomes., Data Sources: MEDLINE®, Embase®, the Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Centre for Agriculture and Biosciences (CAB) Abstracts from 2000 to August 2015; eligible studies from the original report; and relevant systematic reviews., Review Methods: We included randomized controlled trials (RCTs) of any defined dose of n-3 FA (or combination) compared to placebo, any other n-3 FA, or alternative dose with an outcome of interest conducted in pregnant or breastfeeding women or neonates (preterm or term). We also included prospective observational studies that analyzed the association between baseline n-3 FA intake or biomarker level and followup outcomes. Postnatal interventions began within a week of birth for term infants and within a week of beginning enteral or oral feeding for preterm infants. Standard methods were used for data abstraction and analysis, according to the Evidence-based Practice Center Methods Guide., Results: We identified 4,275 potentially relevant titles from our searches, of which 95 RCTs and 48 observational studies met the inclusion criteria. Risk of bias was a concern with both RCTs and observational studies. Outcomes for which evidence was sufficient to draw a conclusion are summarized here with the Strength of Evidence (SoE). (Outcomes for which the evidence was insufficient to draw a conclusion are summarized in Appendix G of the report.)., Maternal Exposures and Outcomes: Gestational length and risk for preterm birth: Prenatal algal docosahexaenoic acid (DHA) or DHA-enriched fish oil supplementation had a small positive effect on length of gestation (moderate SoE), but no effect on risk for preterm birth (low SoE). Prenatal EPA (eicosapentaenoic acid) plus DHA-containing fish oil supplementation has no effect on length of gestation (low SoE). Supplementation with DHA, or EPA plus DHA-, or DHA-enriched fish oil does not decreaserisk for preterm birth (low SoE)., Birth weight and risk for low birth weight: Changes in maternal n-3 FA biomarkers were significantly associated with birth weight. Prenatal algal DHA or DHA-enriched fish oil supplementation had a positive effect on birth weight among healthy term infants (moderate SoE), but prenatal DHA supplementation had no effect on risk for low birth weight (low SoE). Prenatal EPA plus DHA or alpha-linolenic acid (ALA) supplementation had no effect on birth weight (low SoE)., Risk for peripartum depression: Maternal n-3 FA biomarkers had no association with risk for peripartum depression. Maternal DHA, EPA, or DHA-enriched fish oil supplementation had no effect on risk for peripartum depression (low SoE)., Risk for gestational hypertension/preeclampsia: Prenatal DHA supplementation among high-risk pregnant women had no effect on the risk for gestational hypertension or preeclampsia (moderate SoE). Prenatal supplementation of any n-3 FA in normal-risk women also had no significant effect on risk for gestational hypertension or preeclampsia (low SoE)., Fetal, Infant, and Child Exposures and Outcomes: Postnatal growth patterns: Maternal fish oil or DHA plus EPA supplementation had no effect on postnatal growth patterns (attainment of weight, length, and head circumference) when administered prenatally (moderate SoE) or both pre- and postnatally (low SoE). Fortification of infant formulas with DHA plus arachidonic acid (AA, an n-6 FA) had no effect on growth patterns of preterm or term infants (low SoE)., Visual acuity: Prenatal supplementation with DHA had no effect on development of visual acuity (low SoE). Supplementing or fortifying preterm infant formula with any n-3 FA had no significant effect on visual acuity assessed by visual evoked potentials (VEP) at 4 or 6 months corrected age (low SoE). Data conflicted on the effectiveness of supplementing infant formula for term infants with n-3 FA depending on when and how visual acuity was assessed (i.e. by VEP or by behavioral methods) and the type of essential FA provided (low SoE)., Neurological development: Prenatal or postnatal n-3 FA supplementation had no consistent effect on neurological development (low SoE)., Cognitive development: Prenatal DHA supplementation with AA or EPA had no effect on cognitive development (moderate SoE). Supplementing breastfeeding women with DHA plus EPA also had no effect on cognitive development in infants and children (low SoE). Supplementing or fortifying preterm infants' formula with DHA plus AA had a positive effect on infant cognition at some short-term followup times (moderate SoE). Supplementing or fortifying infant formula for term infants with any n-3 FA had no effect on cognitive development (low SoE). Evidence is insufficient to support any effect of n-3 FA infant supplementation on long-term cognitive outcomes., Autism spectrum disorder, attention deficit hyperactivity disorder (ADHD), and learning disorders: Maternal or infant n-3 FA supplementation had no effect on risk for autism spectrum disorders or ADHD (low SoE). No studies on other learning disorders were identified., Atopic dermatitis (AD), allergies, and respiratory disorders: Pre- and postnatal (maternal and infant) n-3 FA supplementation had no consistent effect on the risk for AD/eczema, allergies, asthma, and other respiratory illnesses (moderate SoE). Biomarkers and intakes had no consistent association with the risk for AD, allergies, and respiratory disorders (low SoE)., Adverse events: Prenatal and infant supplementation with n-3 FA or fortification of foods with n-3 FA did not result in any serious or nonserious adverse events (moderate SoE); with the exception of an increased risk for mild gastrointestinal symptoms., Conclusions: Most studies in this report examined the effects of fish oil (or other combinations of DHA and EPA) supplements on pregnant or breastfeeding women or the effects of infant formula fortified with DHA plus AA. As with the original report, with the exception of small increases in birth weight and length of gestation,n-3 FA supplementation or fortification has no consistent evidence of effects on peripartum maternal or infant health outcomes. No effects of n-3 FA were seen on gestational hypertension, peripartum depression, or postnatal growth. Apparent effects of n-3 FA supplementation were inconsistent across assessment methods and followup times for outcomes related to infant visual acuity, cognitive development and prevention of allergy and asthma. Future RCTs need to assess standardized preparations of n-3 and n-6 FA, using a select group of clinically important outcomes, on populations with baseline n-3 FA intakes typical of those of most western populations., Competing Interests: None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report., (This publication is in the public domain.)

Importance: Evidence supports palliative care effectiveness. Given workforce constraints and the costs of new services, payers and providers need help to prioritize their investments. They need to know which patients to target, which personnel to hire, and which services best improve outcomes., Objective: To inform how payers and providers should identify patients with "advanced illness" and the specific interventions they should implement, we reviewed the evidence to identify (1) individuals appropriate for palliative care and (2) elements of health service interventions (personnel involved, use of multidisciplinary teams, and settings of care) effective in achieving better outcomes for patients, caregivers, and the healthcare system., Evidence Review: Systematic searches of MEDLINE, EMBASE, PsycINFO, Web of Science, and Cochrane Database of Systematic Reviews databases (1/1/2001-1/8/2015)., Results: Randomized controlled trials (124) met inclusion criteria. The majority of studies in cancer (49%, 38 of 77 studies) demonstrated statistically significant patient or caregiver outcomes (e.g., p < 0.05), as did those in congestive heart failure (CHF) (62%, 13 of 21), chronic obstructive pulmonary disease (COPD; 58%, 11 of 19), and dementia (60%, 15 of 25). Most prognostic criteria used clinicians' judgment (73%, 22 of 30). Most interventions included a nurse (70%, 69 of 98), and many were nurse-only (39%, 27 of 69). Social workers were well represented, and home-based approaches were common (56%, 70 of 124). Home interventions with visits were more effective than those without (64%, 28 of 44; vs. 46%, 12 of 26). Interventions improved communication and care planning (70%, 12 of 18), psychosocial health (36%, 12 of 33, for depressive symptoms; 41%, 9 of 22, for anxiety), and patient (40%, 8 of 20) and caregiver experiences (63%, 5 of 8). Many interventions reduced hospital use (65%, 11 of 17), but most other economic outcomes, including costs, were poorly characterized. Palliative care teams did not reliably lower healthcare costs (20%, 2 of 10)., Conclusions: Palliative care improves cancer, CHF, COPD, and dementia outcomes. Effective models include nurses, social workers, and home-based components, and a focus on communication, psychosocial support, and the patient or caregiver experience. High-quality research on intervention costs and cost outcomes in palliative care is limited.

The Veterans Access, Choice, and Accountability Act of 2014 addressed the need for access to timely, high-quality health care for veterans. Section 201 of the legislation called for an independent assessment of various aspects of veterans' health care. The RAND Corporation was tasked with an assessment of the Department of Veterans Affairs (VA) current and projected health care capabilities and resources. An examination of data from a variety of sources, along with a survey of VA medical facility leaders, revealed the breadth and depth of VA resources and capabilities: fiscal resources, workforce and human resources, physical infrastructure, interorganizational relationships, and information resources. The assessment identified barriers to the effective use of these resources and capabilities. Analysis of data on access to VA care and the quality of that care showed that almost all veterans live within 40 miles of a VA health facility, but fewer have access to VA specialty care. Veterans usually receive care within 14 days of their desired appointment date, but wait times vary considerably across VA facilities. VA has long played a national leadership role in measuring the quality of health care. The assessment showed that VA health care quality was as good or better on most measures compared with other health systems, but quality performance lagged at some VA facilities. VA will require more resources and capabilities to meet a projected increase in veterans' demand for VA care over the next five years. Options for increasing capacity include accelerated hiring, full nurse practice authority, and expanded use of telehealth.

Theranostic nanoparticle development recently took center stage in the field of drug delivery nanoreagent design. Theranostic nanoparticles combine therapeutic delivery systems (liposomes, micelles, nanoemulsions, etc.) with imaging reagents (MRI, optical, PET, CT). This combination allows for non-invasive in vivo monitoring of therapeutic nanoparticles in diseased organs and tissues. Here, we report a novel perfluoropolyether (PFPE) nanoemulsion with a water-insoluble lipophilic drug. The formulation enables non-invasive monitoring of nanoemulsion biodistribution using two imaging modalities, (19)F MRI and near-infrared (NIR) optical imaging. The nanoemulsion is composed of PFPE-tyramide as a (19)F MRI tracer, hydrocarbon oil, surfactants, and a NIR dye. Preparation utilizes a combination of self-assembly and high energy emulsification methods, resulting in droplets with average diameter 180 nm and low polydispersity index (PDI less than 0.2). A model nonsteroidal anti-inflammatory drug (NSAID), celecoxib, was incorporated into the formulation at 0.2 mg/mL. The reported nanoemulsion's properties, including small particle size, visibility under (19)F NMR and NIR fluorescence spectroscopy, and the ability to carry drugs make it an attractive potential theranostic agent for cancer imaging and treatment.