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Nonpharmacological treatments are considered first-line pain management strategies, but they remain clinically underused. For years, pain-focused pragmatic clinical trials (PCTs) have generated evidence for the enhanced use of nonpharmacological interventions in routine clinical settings to help overcome implementation barriers. The Pragmatic Explanatory Continuum Indicator Summary (PRECIS-2) framework describes the degree of pragmatism across nine key domains. Among these, "flexibility in delivery" and "flexibility in adherence," address a key goal of pragmatic research by tailoring approaches to settings in which people receive routine care. However, to maintain scientific and ethical rigor, PCTs must ensure that flexibility features do not compromise delivery of interventions as designed, such that the results are ethically and scientifically sound. Key principles of achieving this balance include clear definitions of intervention core components, intervention monitoring and documentation that is sufficient but not overly burdensome, provider training that meets the demands of delivering an intervention in real-world settings, and use of an ethical lens to recognize and avoid potential trial futility when necessary and appropriate. PERSPECTIVE: This article presents nuances to be considered when applying the PRECIS-2 framework to describe pragmatic clinical trials. Trials must ensure that patient-centered treatment flexibility does not compromise delivery of interventions as designed, such that measurement and analysis of treatment effects is reliable.

Background Interest in complementary and integrative health (CIH) approaches, such as meditation, yoga, and acupuncture, continues to grow. The evidence of effectiveness for some CIH approaches has increased in the last decade, especially for pain, with many being recommended in varying degrees in national guidelines. To offer nonpharmacological health management options and meet patient demand, the nation’s largest integrated healthcare system, the Veterans Health Administration (VA), greatly expanded their provision of CIH approaches recently. Objective This paper addressed the questions of how many VA patients might use CIH approaches and chiropractic care if they were available at modest to no fee, and would patients with some health conditions or characteristics be more likely than others to use these therapies. Design Using electronic medical records, we conducted a national, three-year, retrospective analysis of VA patients’ use of eleven VA-covered therapies: chiropractic care, acupuncture, Battlefield Acupuncture, biofeedback, clinical hypnosis, guided imagery, massage therapy, meditation, Tai Chi/Qigong, and yoga. Participants We created a national cohort of veterans using VA healthcare from October 2016–September 2019. Key Results Veterans’ use of these approaches increased 70% in three years. By 2019, use was 5.7% among all VA patients, but highest among patients with chronic musculoskeletal pain (13.9%), post-traumatic stress disorder (PTSD; 10.6%), depression (10.4%), anxiety (10.2%), or obesity (7.8%). The approach used varied by age and race/ethnicity, with women being uniformly more likely than men to use each approach. Patients having chronic musculoskeletal pain, obesity, anxiety, depression, or PTSD were more likely than others to use each of the approaches. Conclusions Veterans’ use of some approaches rapidly grew recently and was robust, especially among patients most in need. This information might help shape federal/state health policy on the provision of evidence-based CIH approaches and guide other healthcare institutions considering providing them.

ObjectiveTo describe how a partnered evaluation of the Whole Health (WH) system of care-comprised of the WH pathway, clinical care, and well-being programs-produced patient outcomes findings, which informed Veterans Health Administration (VA) policy and system change.Data sourcesElectronic health records (EHR)-based cohort of 1,368,413 patients and a longitudinal survey of Veterans receiving care at 18 WH pilot medical centers.Study designIn partnership with VA operations, we focused the evaluation on the impact of WH services utilization on Veterans' (1) use of opioids and (2) care experiences, care engagement, and well-being. Outcomes were compared between Veterans who did and did not use WH services identified from the EHR.Data collectionPharmacy records and WH service data were obtained from the VA EHR, including WH coaching, peer-led groups, personal health planning, and complementary, integrative health therapies. We surveyed veterans at baseline and 6months to measure patient-reported outcomes.Principal findingsOpioid use decreased 23% (31.5-6.5) to 38% (60.3-14.4) among WH users depending on level of WH use compared to a secular 11% (12.0-9.9) decrease among Veterans using Conventional Care. Compared to Conventional Care users, WH users reported greater improvements in perceptions of care (SMD=0.138), engagement in health care (SMD=0.118) and self-care (SMD=0.1), life meaning and purpose (SMD=0.152), pain (SMD=0.025), and perceived stress (SMD=0.191).ConclusionsEvidence developed through this partnership yielded key VA policy changes to increase Veteran access to WH services. Findings formed the foundation of a congressionally mandated report in response to the Comprehensive Addiction and Recovery Act, highlighting the value of WH and complementary, integrative health and well-being programs for Veterans with pain. Findings subsequently informed issuance of an Executive Decision Memo mandating the integration of WH into mental health and primary care across VA, now one lane of modernization for VA.

Pragmatic clinical trials (PCTs) are well-suited to address unmet healthcare needs, such as those arising from the dual public health crises of chronic pain and opioid misuse, recently exacerbated by the COVID-19 pandemic. These overlapping epidemics have complex, multifactorial etiologies, and PCTs can be used to investigate the effectiveness of integrated therapies that are currently available but underused. Yet individual pragmatic studies can be limited in their reach because of existing structural and cultural barriers to dissemination and implementation. The National Institutes of Health, Department of Defense, and Department of Veterans Affairs formed an interagency research partnership, the Pain Management Collaboratory. The partnership combines pragmatic trial design with collaborative tools and relationship building within a large network to advance the science and impact of nonpharmacological approaches and integrated models of care for the management of pain and common co-occurring conditions. The Pain Management Collaboratory team supports 11 large-scale, multisite PCTs in veteran and military health systems with a focus on team science with the shared aim that the “whole is greater than the sum of the parts.” Herein, we describe this integrated approach and lessons learned, including incentivizing all parties; proactively offering frequent opportunities for problem-solving; engaging stakeholders during all stages of research; and navigating competing research priorities. We also articulate several specific strategies and their practical implications for advancing pain management in active clinical, “real-world,” settings.

Opioid-related harms disproportionately affect rural communities. Recent research-based policy changes have called for reductions in opioid prescribing and substitution of safe and effective alternatives to opioids for treating chronic pain, but such alternatives are often difficult to access in rural areas. Telehealth services can help address this disparity by bringing evidence-based, biopsychosocial chronic-pain services to rural and underserved patients with chronic pain. This article describes a 2-year pilot project for delivering chronic-pain care by pain specialists from central hubs at Veterans Health Administration (VA) medical centers to spokes at VA community-based outpatient clinics (CBOCs). The VA Puget Sound Pain Telehealth pilot program offered pain education classes, cognitive-behavioral therapy groups, opioid-safety education, and acupuncture education. The program delivered 501 encounters to patients from 1 hub to 4 CBOC spoke sites from 2016 to 2018, and supported training, administration, equipment acquisition, and grant-writing. The quality-improvement project was rolled out using existing local resources. We present initial findings about the patients who utilized Pain Telehealth, share lessons learned, and discuss future directions for expansion. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

BACKGROUND: Implementation of effective smoking cessation interventions in lung cancer screening has been identified as a high-priority research gap, but knowledge of current practices to guide process improvement is limited due to the slow uptake of screening and dearth of data to assess cessation-related practices and outcomes under real-world conditions. OBJECTIVE: To evaluate cessation treatment receipt and 1-year post-screening cessation outcomes within the largest integrated healthcare system in the USA—the Veterans Health Administration (VHA). Design Observational study using administrative data from electronic medical records (EMR). Patients Currently smoking Veterans who received a first lung cancer screening test using low-dose CT (LDCT) between January 2014 and June 2018. Main Outcomes Tobacco treatment received within the window of 30 days before and 30 days after LDCT; 1-year quit rates based on EMR Smoking Health Factors data 6–18 months after LDCT. Key Results Of the 47,609 current smokers screened (95.3% male), 8702 (18.3%) received pharmacotherapy and/or behavioral treatment for smoking cessation; 531 (1.1%) received both. Of those receiving pharmacotherapy, only one in four received one of the most effective medications: varenicline (12.1%) or combination nicotine replacement therapy (14.3%). Overall, 5400 Veterans quit smoking—a rate of 11.3% (missing=smoking) or 13.5% (complete case analysis). Treatment receipt and cessation were associated with numerous sociodemographic, clinical, and screening-related factors. CONCLUSIONS: One-year quit rates for Veterans receiving lung cancer screening in VHA are similar to those reported in LDCT clinical trials and cohort studies (i.e., 10–17%). Only 1% of Veterans received the recommended combination of pharmacotherapy and counseling, and the most effective pharmacotherapies were not the most commonly received ones. The value of screening within VHA could be improved by addressing these treatment gaps, as well as the observed disparities in treatment receipt or cessation by race, rurality, and psychiatric conditions. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11606-021-07011-0.

Background Guidelines recommend offering cessation interventions to smokers eligible for lung cancer screening, but there is little data comparing specific cessation approaches in this setting. We compared the benefits and costs of different smoking cessation interventions to help screening programs select specific cessation approaches. Methods We conducted a societal-perspective cost-effectiveness analysis using a Cancer Intervention and Surveillance Modeling Network model simulating individuals born in 1960 over their lifetimes. Model inputs were derived from Medicare, national cancer registries, published studies, and micro-costing of cessation interventions. We modeled annual lung cancer screening following 2014 US Preventive Services Task Force guidelines plus cessation interventions offered to current smokers at first screen, including pharmacotherapy only or pharmacotherapy with electronic and/or web-based, telephone, individual, or group counseling. Outcomes included lung cancer cases and deaths, life-years saved, quality-adjusted life-years (QALYs) saved, costs, and incremental cost-effectiveness ratios. Results Compared with screening alone, all cessation interventions decreased cases of and deaths from lung cancer. Compared incrementally, efficient cessation strategies included pharmacotherapy with either web-based cessation ($555 per QALY), telephone counseling ($7562 per QALY), or individual counseling ($35 531 per QALY). Cessation interventions continued to have costs per QALY well below accepted willingness to pay thresholds even with the lowest intervention effects and was more cost-effective in cohorts with higher smoking prevalence. Conclusion All smoking cessation interventions delivered with lung cancer screening are likely to provide benefits at reasonable costs. Because the differences between approaches were small, the choice of intervention should be guided by practical concerns such as staff training and availability.

Background Many health care systems are beginning to encourage patients to use complementary and integrative health (CIH) therapies for pain management. Many clinicians have anecdotally reported that patients combining self-care CIH therapies with practitioner-delivered therapies report larger health improvements than do patients using practitioner-delivered or self-care CIH therapies alone. However, we are unaware of any trials in this area. Design The APPROACH Study (Assessing Pain, Patient-Reported Outcomes and Complementary and Integrative Health) assesses the value of veterans participating in practitioner-delivered CIH therapies alone or self-care CIH therapies alone compared with the combination of self-care and practitioner-delivered care. The study is being conducted in 18 Veterans Health Administration sites that received funding as part of the Comprehensive Addiction and Recovery Act to expand availability of CIH therapies. Practitioner-delivered therapies under study include chiropractic care, acupuncture, and therapeutic massage, and self-care therapies include tai chi/qi gong, yoga, and meditation. The primary outcome will be improvement on the Brief Pain Inventory 6 months after initiation of CIH as compared with baseline scores. Patients will enter treatment groups on the basis of the care they receive because randomizing patients to specific CIH therapies would require withholding therapies routinely offered at VA. We will address selection bias and confounding by using sites’ variations in business practices and other encouragements to receive different types of CIH therapies as a surrogate for direct randomization by using instrumental variable econometrics methods. Summary Real-world evidence about the value of combining self-care and practitioner-delivered CIH therapies from this pragmatic trial will help guide the VA and other health care systems in offering specific nonpharmacological approaches to manage patients’ chronic pain.

Objective To understand how to potentially improve inappropriate prostate cancer imaging rates we used National Comprehensive Cancer Network's guidelines to design and implement a Clinical Reminder Order Check (CROC) that alerts ordering providers of potentially inappropriate imaging orders in real-time based on patient features of men diagnosed with low-risk prostate cancer. Methods We implemented the CROC at VA New York Harbor Healthcare System from April 2, 2015 to November 15, 2017. We then used VA administrative claims from the VA's Corporate Data Warehouse to analyze imaging rates among men with low-risk prostate cancer at VA New York Harbor Healthcare System before and after CROC implementation. We also collected and cataloged provider responses in response to overriding the CROC in qualitative analysis. Results Fifty seven percent (117/205) of Veterans before CROC installation and 73% (61/83) of Veterans post-intervention with low-risk prostate cancer received guideline-concordant care. Conclusion While the decrease in inappropriate imaging during our study window was almost certainly due to many factors, a Computerized Patient Record System-based CROC intervention is likely associated with at least moderate improvement in guideline-concordant imaging practices for Veterans with low-risk prostate cancer.

Background Lung cancer screening (LCS) is now recommended for people at high risk of dying of lung cancer. Research question The purpose of this study was to use the LCS decision discussion as a case study to understand possible underlying components of a teachable moment to enhance motivation for smoking cessation. Study design and methods The study investigated how patients and clinicians communicate about smoking. In-depth, semi-structured interviews were performed of the experiences of 51 individuals who formerly or currently smoked who were offered LCS and 24 clinicians. Only the baseline interviews were used because including the follow-up interviews would have been beyond the scope of this article. The interviews focused on communication about smoking, the perceived importance of discussing smoking and screening together, and patients' perceived challenges to smoking cessation. Results Patients and clinicians differed in their views on the role of the LCS decision discussion as a teachable moment. Although clinicians felt that this discussion was a good opportunity to positively influence smoking behaviors, neither patients nor clinicians perceived the discussion as a teachable moment affecting smoking behaviors. Other motivating factors for smoking cessation were found. Interpretation Our findings indicate that LCS decision discussions are not currently a teachable moment for behavior change in smoking cessation, but perhaps clinicians could address other aspects of communication to enhance motivation for cessation. Our hypothesized teachable moment model helps explain that there may not be sufficient emotional response elicited during the discussion to motivate a major behavior change such as smoking cessation.

Background In 2012, the United States Preventative Services Task Force (USPSTF) formally recommended against all prostate-specific antigen (PSA) screening for prostate cancer. Our goal was to characterize PSA screening trends in the Veterans Health Administration (VA) before and after the USPSTF recommendation and to determine if PSA screening was more likely to be ordered based on a veteran’s race or age. Methods Using the VA Corporate Data Warehouse, we created 10 annual groups of PSA-eligible men covering 2009-2018. We identified all PSA tests performed in the VA to determine yearly rates of PSA screening. All statistical tests were 2-sided. Results The overall rate of PSA testing in the VA decreased from 63.3% in 2009 to 51.2% in 2018 (P < .001). PSA screening rates varied markedly by age group during our study period, with men aged 70-80 years having the highest initial rate and greatest decline (70.6% in 2009 to 48.4% in 2018, P < .001). Men aged 55-69 years had a smaller decline (65.2% in 2009 to 58.9% in 2018, P < .001) whereas the youngest men, aged 40-54 years, had an increase in PSA screening (26.2% in 2009 to 37.8% in 2018, P < .001). Conclusions In this analysis of PSA screening rates among veterans before and after the 2012 USPSTF recommendation against screening, we found that overall PSA screening decreased only modestly, continuing for more than one-half of the men in our study. Veterans of different races had similar screening rates, suggesting that VA care may minimize racial disparities. Veterans of varying ages experienced statistically significantly differences in PSA screening trends.

Objectives: Veterans Health Administration encourages auricular acupuncture (Battlefield Acupuncture/BFA) as a nonpharmacologic approach to pain management. Qualitative reports highlighted a “gateway hypothesis”: providing BFA can lead to additional nonpharmacologic treatments. This analysis examines subsequent use of traditional acupuncture. Research Design: Cohort study of Veterans treated with BFA and a propensity score matched comparison group with a 3-month follow-up period to identify subsequent use of traditional acupuncture. Matching variables included pain, comorbidity, and demographics, with further adjustment in multivariate regression analysis. Subjects: We identified 41,234 patients who used BFA across 130 Veterans Health Administration medical facilities between October 1, 2016 and March 31, 2019. These patients were matched 2:1 on Veterans who used VA care but not BFA during the same period resulting in a population of 24,037 BFA users and a comparison cohort of 40,358 non-BFA users. Patients with prior use of traditional acupuncture were excluded. Results: Among Veterans receiving BFA, 9.5% subsequently used traditional acupuncture compared with 0.9% of non-BFA users (P

Background Veterans in the United States are at an increased risk of chronic pain and have higher reported pain prevalence and severity than nonveterans. This qualitative study aims to examine veterans’ perspectives on the acceptability of receiving pain care through TelePain, a telehealth program implemented by the Veterans Health Administration (VA) that offers specialty pain care to rural veterans in their homes or in a video conferencing room at a nearby outpatient clinic. Methods The VA electronic health record was used to identify patients who were referred to TelePain from rural clinics located in Washington, Oregon, and Alaska between 12/01/2019 and 03/31/2020. The study team completed 16 semi-structured interviews with rural veterans about their experiences with TelePain. After interview transcripts were recorded digitally and transcribed, Atlas.ti was used to organize data and facilitate qualitative coding. Interview transcripts were analyzed using thematic analysis. Results Veterans reported general satisfaction with receiving pain care through telehealth and valued having supportive, knowledgeable providers who provided useful information and resources. In addition, veterans appreciated the convenience of telehealth. Barriers to care included problems with program follow-up, negative perceptions of mental health care for pain, and preference for in-person care. Although some patients suggested that telehealth audio and video could be improved, most patients did not have any significant problems with telehealth technology. Conclusions In this sample of rural veterans who used TelePain, many reported satisfaction with the program and positive experiences with providers. Targets for quality improvement include streamlining the program’s referral and scheduling process and improving patient motivation to engage in psychological pain treatments. Results indicate that delivering pain services over telehealth is an acceptable modality for this patient population.

To describe the association between exposure to selected complementary and integrative health (CIH) modalities and the trajectory of prescribed opioid analgesic dose within a national cohort of patients receiving long-term opioid therapy (LTOT) in the Veterans Health Administration (VHA).Using national data from VHA electronic health records between October 1, 2017 and September 30, 2019, CIH use was analyzed among 57,437 patients receiving LTOT within 18 VHA facilities serving as evaluation sites of VHA's Whole Health System of Care. Using linear mixed effects modeling controlling for covariates, opioid dose was modeled as a function of time, CIH exposure, and their interaction.Overall, 11.91% of patients on LTOT used any of the focus CIH therapies; 43.25% of those had 4 or more encounters. Patients used acupuncture, chiropractic care, and meditation modalities primarily. CIH use was associated with being female, Black, having a mental health diagnosis, obesity, pain intensity, and baseline morphine-equivalent daily dose. Mean baseline morphine-equivalent daily dose was 40.81 milligrams and dose decreased on average over time. Controlling for covariates, patients with any CIH exposure experienced 38% faster dose tapering, corresponding to a mean difference in 12-month reduction over patients not engaging in CIH of 2.88 milligrams or 7.06% of the mean starting dose.Results support the role of CIH modalities in opioid tapering. The study design precludes inference about the causal effects of CIH on tapering. Analyses did not consider the trend in opioid dose before cohort entry nor the use of other nonopioid treatments for pain. Future research should address these questions and consider tapering-associated adverse events.

Background Almost half of Veterans with localized prostate cancer receive inappropriate, wasteful staging imaging. Our team has explored the barriers and facilitators of guideline-concordant prostate cancer imaging and found that (1) patients with newly diagnosed prostate cancer have little concern for radiographic staging but rather focus on treatment and (2) physicians trust imaging guidelines but are apt to follow their own intuition, fear medico-legal consequences, and succumb to influence from imaging-avid colleagues. We used a theory-based approach to design a multi-level intervention strategy to promote guideline-concordant imaging to stage incident prostate cancer. Methods We designed the Prostate Cancer Imaging Stewardship (PCIS) intervention: a multi-site, stepped wedge, cluster-randomized trial to determine the effect of a physician-focused behavioral intervention on Veterans Health Administration (VHA) prostate cancer imaging use. The multi-level intervention, developed according to the Theoretical Domains Framework (TDF) and Behavior Change Wheel, combines traditional physician behavior change methods with novel methods of communication and data collection. The intervention consists of three components: (1) a system of audit and feedback to clinicians informing individual clinicians and their sites about how their behavior compares to their peers’ and to published guidelines, (2) a program of academic detailing with the goal to educate providers about prostate cancer imaging, and (3) a CPRS Clinical Order Check for potentially guideline-discordant imaging orders. The intervention will be introduced to 10 participating geographically distributed study sites. Discussion This study is a significant contribution to implementation science, providing VHA an opportunity to ensure delivery of high-quality care at the lowest cost using a theory-based approach. The study is ongoing. Preliminary data collection and recruitment have started; analysis has yet to be performed. Trial registration CliniclTrials.gov NCT03445559. Prospectively registered on February 26, 2018

Inhaled corticosteroid (ICS) use among patients with COPD increases the risk of pneumonia and other complications. Current recommendations limit ICS use to patients with frequent or severe COPD exacerbations. However, use of ICS among patients with COPD is common and may be occurring both among those with mild disease (overuse) and those misdiagnosed with COPD (misuse). To identify patients without identifiable indication for ICS and assess patient and provider characteristics associated with potentially inappropriate to targeted in de-implementation efforts We performed a cross-sectional study of patients with COPD in the Veterans Affairs (VA) system with recent spirometry. After setting an index date, we identified individuals with a clinical diagnosis of COPD who had spirometry completed in the prior 5 years. We excluded individuals with an appropriate indication for ICS based on the 2017 GOLD statement, including asthma and a recent history of frequent or severe exacerbations. ICS use without identifiable indication We identified 26,536 patients with COPD without an identifiable indication for ICS. Nearly ¼ of patients (n = 6330) filled ≥2 prescriptions for ICS in the year prior to the index date. We found that older age (adjusted prevalence ratio [APR] 1.06 per decade, 95% confidence interval [CI] 1.04–1.08), white race (APR 1.11, 95% CI 1.05–1.19), and more primary care visits (APR 1.05 per visit, 95% CI 1.03–1.07) were associated with increased likelihood of potentially inappropriate use. Primary care clinic complexity and provider training were not associated with ICS use. Among patients misdiagnosed with COPD, we found that 14% used ICS. Potentially inappropriate ICS use is common among patients with and without airflow obstruction who are diagnosed with COPD. We identified patient comorbidities and patterns of healthcare utilization that increase the likelihood of ICS use that could be targeted for system-level de-implementation interventions.

Complementary and integrative health (CIH) approaches are increasingly utilized in health care, and mindfulness meditation is one such evidence-based CIH practice. More information is needed about veterans’ utilization of mindfulness to inform integration within the Veterans Health Administration (VHA). This study involved secondary data analysis of a national survey to evaluate utilization and perceived effectiveness of mindfulness relative to other CIH approaches among military veterans. Military veterans (n = 1230) enrolled in VHA reported CIH utilization rates, reasons for use, perceived effectiveness, treatment barriers, and demographics. Approximately 18% of veterans reported using mindfulness meditation in the past year, exceeding the proportion using all other CIH approaches (p

Objective Examine changes in specialty pain utilization in the Veterans Health Administration (VHA) after establishing a virtual interdisciplinary pain team (TelePain). Design Retrospective cohort study. Setting A single VHA healthcare system, 2015–2019. Subjects 33,169 patients with chronic pain-related diagnoses. Methods We measured specialty pain utilization (in-person and telehealth) among patients with moderate to severe chronic pain. We used generalized estimating equations to test the association of time (pre- or post-TelePain) and rurality on receipt of specialty pain care. Results Among patients with moderate to severe chronic pain, the reach of specialty pain care increased from 11.1% to 16.2% in the pre- to post-TelePain periods (adjusted odds ratio [aOR]: 1.37, 95% confidence interval [CI]: 1.26–1.49). This was true of both urban patients (aOR: 1.62, 95% CI: 1.53–1.71) and rural patients (aOR: 1.16, 95% CI: 0.99–1.36), although the difference for rural patients was not statistically significant. Among rural patients who received specialty pain care, a high percentage of the visits were delivered by telehealth (nearly 12% in the post-TelePain period), much higher than among urban patients (3%). Conclusions We observed increased use of specialty pain services among all patients with chronic pain. Although rural patients did not achieve the same degree of access and utilization overall as urban patients, their use of pain telehealth increased substantially and may have substituted for in-person visits. Targeted implementation efforts may be needed to further increase the reach of services to patients living in areas with limited specialty pain care options.

INTRODUCTION: Chest imaging often incidentally finds indeterminate nodules that need to be monitored to ensure early detection of lung cancers. Health care systems need effective approaches for identifying these lung nodules. We compared the diagnostic performance of 2 approaches for identifying patients with lung nodules on imaging studies (chest/abdomen): (1) relying on radiologists to code imaging studies with lung nodules; and (2) applying a text search algorithm to identify references to lung nodules in radiology reports. METHODS: We assessed all radiology studies performed between January 1, 2016 and November 30, 2016 in a single Veterans Health Administration hospital. We first identified imaging reports with a diagnostic code for a pulmonary nodule. We then applied a text search algorithm to identify imaging reports with key words associated with lung nodules. We reviewed medical records for all patients with a suspicious radiology report based on either search strategy to confirm the presence of a lung nodule. We calculated the yield and the positive predictive value (PPV) of each search strategy for finding pulmonary nodules. RESULTS: We identified 12,983 imaging studies with a potential lung nodule. Chart review confirmed 8,516 imaging studies with lung nodules, representing 2,912 unique patients. The text search algorithm identified all the patients with lung nodules identified by the radiology coding (n = 1,251) as well as an additional 1,661 patients. The PPV of the text search was 72% (2,912/4,071) and the PPV of the radiology code was 92% (1,251/1,363). Among the patients with nodules missed by radiology coding but identified by the text search algorithm, 130 had lung nodules > 8 mm in diameter. CONCLUSIONS: The text search algorithm can identify additional patients with lung nodules compared to the radiology coding; however, this strategy requires substantial clinical review time to confirm nodules. Health care systems adopting nodule-tracking approaches should recognize that relying only on radiology coding might miss clinically important nodules.

Objectives Veterans Health Administration (VHA) launched a national initiative to train providers in a specific, protocolized auricular acupuncture treatment (also called Battlefield Acupuncture or BFA) as a nonpharmacological approach to pain management. This evaluation assessed the real-world effectiveness of BFA on immediate pain relief and identified subgroups of patients for whom BFA is most effective. Research design In a cross-sectional cohort study, electronic medical record data for 11,406 Veterans treated with BFA at 57 VHA medical centers between October 2016 and September 2018 was analyzed. The multivariate analysis incorporated data on pain history, change in pain level on an 11-point scale, complications, and demographic information. Methods A total of 11,406 Veterans were treated with BFA at 57 VHA medical centers between October 2016 and September 2018 and had effectiveness data recorded in their electronic medical record. Results More than 3 quarters experienced immediate decreases in pain following administration of BFA, with nearly 60% reported experiencing a minimal clinically important difference in pain intensity. The average decrease in pain intensity was -2.5 points (SD=2.2) at the initial BFA treatment, and -2.2 points (SD=2.0) at subsequent treatments. BFA was effective across a wide range of Veterans with many having preexisting chronic pain, or physical, or psychological comorbid conditions. Veterans with opioid use in the year before BFA experienced less improvement, with pain intensity scores improving more among Veterans who had not recently used opioids. Conclusion VHA's rapid expansion of training providers to offer BFA as a nonpharmacological approach to pain management has benefited many Veterans.

RESEARCH OBJECTIVE: VHA is piloting the Whole Health System of Care (WHS) at 18 sites to shift care from a disease‐focused “find‐it, fix‐it” model to one driven by patients’ personal health goals, to foster patient self‐management, and to improve well‐being. As part of the Comprehensive Addiction and Recovery Act, VHA initiated a demonstration program in 18 VA Medical Centers to implement WHS. We report on its impact on Veterans. STUDY DESIGN: A longitudinal survey of Veterans with chronic pain at the 18 flagship medical centers. Veterans were surveyed at baseline and 6 months using 12 patient‐reported outcome measures. Outcomes were compared between Veterans who did not use WHS services and Veterans with different levels of WHS service use, using standardized mean differences/Cohen’s D. We conducted a longitudinal cohort analysis of Veterans who started using WHS after April 2018. This analysis compared opioid dose levels using administrative pharmacy data (quarterly morphine equivalents) for the 6‐month period before using WHS to opioid levels one year later. This analysis included Veterans from the same time periods who did not use WHS services. POPULATION STUDIED: Survey: a random sample of Veterans with chronic musculoskeletal pain at 18 VA medical centers; we report on 3622 patients who completed baseline and 6‐month surveys (response rate: 49.3% baseline; 74.2% follow‐up). Administrative cohort analysis: 112 202 Veterans with chronic pain who received continuous VA care between October 2017 and March 2019 and used >2 WHS (without WHS services prior to April 2018) or no WHS throughout the evaluation period. PRINCIPAL FINDINGS: 46% of survey respondents and 5.9% of the administrative cohort used >2 WHS services. Effect sizes for survey measures were small overall; however, those who used WHS services reported greater improvements in perceptions of care, engagement in health care and self‐care, life meaning and purpose, pain, and perceived stress. Opioid use among Veterans using WHS decreased 23% compared with 11% decrease among those with no WHS use. CONCLUSIONS: WHS use, especially high levels of WHS use, was positively associated with improvements in several patient‐reported health and well‐being outcomes. While effect sizes were small for survey measures over this 6‐month period, they are promising for the future impact of VHA’s WHS initiative. Administrative data identified meaningful reductions in opioid use among WHS users. IMPLICATIONS FOR POLICY OR PRACTICE: The use of WHS services among Veterans with chronic pain has important implications for pain management, and Veteran health and well‐being. Implementing a system of care that is designed to provide these services to patients presents an opportunity to radically change the way health care is delivered and impact patients’ lives and not just fix their diseases. PRIMARY FUNDING SOURCE: Department of Veterans Affairs.

Electronic health record data can be used in multiple ways to facilitate real-world pragmatic studies. Electronic health record data can provide detailed information about utilization of treatment options to help identify appropriate comparison groups, access historical clinical characteristics of participants, and facilitate measuring longitudinal outcomes for the treatments being studied. An additional novel use of electronic health record data is to assess and understand referral pathways and other business practices that encourage or discourage patients from using different types of care. We describe an ongoing study utilizing access to real-time electronic health record data about changing patterns of complementary and integrative health services to demonstrate how electronic health record data can provide the foundation for a pragmatic study when randomization is not feasible. Conducting explanatory trials of the value of emerging therapies within a healthcare system poses ethical and pragmatic challenges, such as withholding access to specific services that are becoming widely available to patients. We describe how prospective examination of real-time electronic health record data can be used to construct and understand business practices as potential surrogates for direct randomization through an instrumental variables analytic approach. In this context, an example of a business practice is the internal hiring of acupuncturists who also provide yoga or Tai Chi classes and can offer these classes without additional cost compared to community acupuncturists. Here, the business practice of hiring internal acupuncturists is likely to encourage much higher rates of combined complementary and integrative health use compared to community referrals. We highlight the tradeoff in efficiency of this pragmatic approach and describe use of simulations to estimate the potential sample sizes needed for a variety of instrument strengths. While real-time monitoring of business practices from electronic health records provides insights into the validity of key independence assumptions associated with the instrumental variable approaches, we note that there may be some residual confounding by indication or selection bias and describe how alternative sources of electronic health record data can be used to assess the robustness of instrumental variable assumptions to address these challenges. Finally, we also highlight that while some clinical outcomes can be obtained directly from the electronic health record, such as longitudinal opioid utilization and pain intensity levels for the study of the value of complementary and integrative health, it is often critical to supplement clinical electronic health record–based measures with patient-reported outcomes. The experience of this example in evaluating complementary and integrative health demonstrates the use of electronic health record data in several novel ways that may be of use for designing future pragmatic trials.

History has shown that we must adapt and learn from crises so that we can improve how we deliver care and conduct research to improve clinical outcomes. The coronavirus disease 2019 (COVID‐19) pandemic has expedited work regarding virtual research methods and serves as an opportunity to evaluate how to initiate, implement, and sustain cancer prevention, early detection, and treatment research going forward.

INTRODUCTION AND OBJECTIVE:In 2012, the US Preventative Services Task Force (USPSTF) formally recommended against all PSA screening for prostate cancer. Notably, the USPSTF recommendation did not p...

Objective: The Department of Veterans Affairs trained primary-care providers to deliver Battlefield Acupuncture (BFA), a subset of auricular acupuncture, to patients. However, little is known about BFA effectiveness in group or individual sessions or repeated administrations versus singular use. The aim of this study was to examine the use and effectiveness of BFA for back pain and four pain-comorbid conditions in group and individual sessions at a large Veterans Affairs (VA) medical center. Materials and Methods: This cross-sectional study was conducted at the West Haven VA Medical Center, in West Haven CT. Between October 2016 and December 2017, 284 veterans with pain received BFA. The BFA was administered in group clinics or in individual encounters. The Defense and Veterans Pain Rating Scale was used to assess self-reported pain immediately before and after each BFA administration. Results: Over the study period, an average of 57 (range: 50-66) new patients per month received BFA. Of 753 total patient encounters, an immediate decrease in self-reported pain occurred in 616 (82.0%) patients, no change occurred in 73 (9.7%) patients, and an increase occurred in 62 (8.3%) patients. Decreases in pain were common in the group and individual settings, even in patients with originally high pain scores, and the effectiveness remained with repeated uses. Conclusions: BFA can be effective for immediate relief of pain-whether the BFA is administered in a group or individual setting-for the overwhelming majority of veterans and, as such, holds promise as a nonpharmacologic pain-management intervention.

OBJECTIVE: To determine how out-of-pocket costs for adjuvant endocrine therapy (AET) medication affects adherence among newly diagnosed breast cancer survivors with private health insurance who initiate therapy. METHODS: We examined medical and pharmacy claims for the 1-year period after initiating AET using the Truven Health Analytics MarketScan® database. Adherence was defined as ≥80% proportion of days covered (PDC). Mean out-of-pocket costs for AET fill were measured as the sum of copayments, coinsurance, and deductibles and adjusted to 30-day amounts. Using a multivariable logistic regression model we calculated adjusted risk ratios controlling for age, comorbidities, type of surgery, use of chemotherapy and/or radiation therapy, average out-of-pocket costs for other services, and pharmacy use characteristics. RESULTS: Of the 6,863 women 64 years and younger who were diagnosed with breast cancer and initiated AET, 73.9% were adherent (PDC≥80%). A total of 19% of patients had less than $5 monthly out-of-pocket costs for AET, 30% had $5–$9.99, 17% had $10–14.99, 10% had $15–19.99, and 25% had $20 or greater. Patients with out-of-pocket costs for AET between $10–14.99, $15–$19.99, and greater than $20 were 6–8% less likely to be adherent compared to patients paying less than $5.00, after controlling for covariates (p

Introduction The purpose of this study is to identify issues faced by Federally Qualified Health Centers (FQHCs) in implementing lung cancer screening in low-resource settings. Methods Medical directors of 258 FQHCs serving communities with tobacco use prevalence above the median of all 1,202 FQHCs nationally were sampled to participate in a web-based survey. Data were collected between August and October 2016. Data analysis was completed in June 2017. Results There were 112 (43%) FQHC medical directors or surrogates who responded to the 2016 survey. Overall, 41% of respondents were aware of a lung cancer screening program within 30 miles of their system’s largest clinic. Although 43% reported that some providers in their system offer screening, it was typically at a very low volume (less than ten/month). Although FQHCs are required to collect tobacco use data, only 13% indicated that these data can identify patients eligible for screening. Many FQHCs reported important patient financial barriers for screening, including lack of insurance (72%), preauthorization requirements (58%), and out-of-pocket cost burdens for follow-up procedures (73%). Only 51% indicated having adequate access to specialty providers to manage abnormal findings, and few reported that leadership had either committed resources to lung cancer screening (12%) or prioritized lung cancer screening (12%). Conclusions FQHCs and other safety-net clinics, which predominantly serve low-socioeconomic populations with high proportions of smokers eligible for lung cancer screening, face significant economic and resource challenges to implementing lung cancer screening. Although these vulnerable patients are at increased risk for lung cancer, reducing patient financial burdens and appropriately managing abnormal findings are critical to ensure that offering screening does not inadvertently lead to harm and increase disparities.

Smoking cessation counseling in conjunction with low-dose computed tomography (LDCT) lung cancer screening is recommended in multiple clinical practice guidelines. The best approach for integrating effective smoking cessation interventions within this setting is unknown.To summarize evidence, identify research gaps, prioritize topics for future research, and propose standardized tools for use in conducting research on smoking cessation interventions within the LDCT lung cancer screening setting.The American Thoracic Society convened a multistakeholder committee with expertise in tobacco dependence treatment and/or LDCT screening. During an in-person meeting, evidence was reviewed, research gaps were identified, and key questions were generated for each of three research domains: (1) target population to study; (2) adaptation, development, and testing of interventions; and (3) implementation of interventions with demonstrated efficacy. We also identified standardized measures for use in conducting this research. A larger stakeholder panel then ranked research questions by perceived importance in an online survey. Final prioritization was generated hierarchically on the basis of average rank assigned.There was little consensus on which questions within the population domain were of highest priority. Within the intervention domain, research to evaluate the effectiveness in the lung cancer screening setting of evidence-based smoking cessation interventions shown to be effective in other contexts was ranked highest. In the implementation domain, stakeholders prioritized understanding strategies to identify and overcome barriers to integrating smoking cessation in lung cancer screening settings.This statement offers an agenda to stimulate research surrounding the integration and implementation of smoking cessation interventions with LDCT lung cancer screening.

Patients with cancer pain often experience inadequate treatment despite availability of evidence-based clinical guidelines.1–3 Nurses’ use of best pain management practices ensures that patients receive optimal pain treatment. Evidence-based pain management (EBPM) requires integrating evidence-based practices through detailed, attentive nursing care which may be impacted by both nurse-level and organizational-level factors.4,5 A lack of research exists on the impact of these factors on EBPM practice among nurses caring for patients with cancer. The purpose of this study was to identify nurse-level and organizational-level factors associated with evidence-based cancer pain management practice as indicated by nurse documentation in the electronic health record (EHR).

Introduction: Many barriers exist to integrating smoking cessation into delivery of lung cancer screening including limited provider time and patient misconceptions.Aims: To demonstrate that proactive outreach from a telephone counsellor outside of the patient's usual care team is feasible and acceptable to patients.Methods: Smokers undergoing lung cancer screening were approached for a telephone counselling study. Patients agreeing to participate in the intervention (n = 27) received two telephone counselling sessions. A 30-day follow-up evaluation was conducted, which also included screening participants receiving usual care (n = 56).Results/Findings: Most (89%) intervention participants reported being satisfied with the proactive calls, and 81% reported the sessions were helpful. Use of behavioural cessation support programs in the intervention group was four times higher (44%) compared to the usual care group (11%); Relative Risk (RR) = 4.1; 95% CI: 1.7 to 9.9), and seven-day abstinence in the intervention group was double (19%) compared to the usual care group (7%); RR = 2.6; 95% CI: 0.8 to 8.9).Conclusions: This practical telephone-based approach, which included risk messages clarifying continued risks of smoking in the context of screening results, suggests such messaging can boost utilisation of evidence-based tobacco treatment, self-efficacy, and potentially increase the likelihood of successful quitting.

Background Although residential segregation has been implicated in various negative health outcomes, its association with kidney transplantation has not been examined. Methods Age- and sex-standardized kidney transplantation rates were calculated from the Scientific Registry of Transplant Recipients, 2000–2013. Population characteristics including segregation indices were derived from the 2010 U.S. Census data and the U.S. Renal Data System. Separate multivariable Poisson regression models were constructed to identify factors independently associated with kidney transplantation among Blacks and Whites. Results Median age- and sex-standardized kidney transplantation rates were 114 per 100,000 for Blacks and 38 per 100,000 for Whites. 16.1% of the U.S. population lived in counties with high segregation. There was no difference in the kidney transplantation rates across the levels of segregation among Blacks and Whites. Conclusion Factors other than residential segregation may play roles in kidney transplantation disparities. Continued efforts to identify these factors may be beneficial in reducing transplantation disparities across the U.S. Summary Using the Scientific Registry of Transplant Recipients and U.S. census data, we aimed to determine whether residential segregation was associated with kidney transplantation rates. We found that there was no association between residential segregation and kidney transplantation rates.

Lung cancer screening (LCS) is now recommended for people at high risk of dying of lung cancer.The purpose of this study was to use the LCS decision discussion as a case study to understand possible underlying components of a teachable moment to enhance motivation for smoking cessation.The study investigated how patients and clinicians communicate about smoking. In-depth, semi-structured interviews were performed of the experiences of 51 individuals who formerly or currently smoked who were offered LCS and 24 clinicians. Only the baseline interviews were used because including the follow-up interviews would have been beyond the scope of this article. The interviews focused on communication about smoking, the perceived importance of discussing smoking and screening together, and patients' perceived challenges to smoking cessation.Patients and clinicians differed in their views on the role of the LCS decision discussion as a teachable moment. Although clinicians felt that this discussion was a good opportunity to positively influence smoking behaviors, neither patients nor clinicians perceived the discussion as a teachable moment affecting smoking behaviors. Other motivating factors for smoking cessation were found.Our findings indicate that LCS decision discussions are not currently a teachable moment for behavior change in smoking cessation, but perhaps clinicians could address other aspects of communication to enhance motivation for cessation. Our hypothesized teachable moment model helps explain that there may not be sufficient emotional response elicited during the discussion to motivate a major behavior change such as smoking cessation.