Changes in Patient-Reported Outcomes Associated with Receiving Whole Health in the Veteran Health Administration (VHA)'s National Demonstration Project.

BACKGROUND: Whole Health (WH) is a patient-centered model of care being implemented by the Veterans Health Administration. Little is known about how use of WH services impacts patients' health and well-being. OBJECTIVE: We sought to assess the association of WH utilization with pain and other patient-reported outcomes (PRO) over 6 months. DESIGN: A longitudinal observational cohort evaluation, comparing changes in PRO surveys for WH users and Conventional Care (CC) users. Inverse probability of treatment weighting was used to balance the two groups on observed demographic and clinical characteristics. PARTICIPANTS: A total of 9689 veterans receiving outpatient care at 18 VA medical centers piloting WH. INTERVENTIONS: WH services included goal-setting clinical encounters, Whole Health coaching, personal health planning, and well-being services. MAIN OUTCOME MEASURES: The primary outcome was change in pain intensity and interference at 6 months using the 3-item PEG. Secondary outcomes included satisfaction, experiences of care, patient engagement in healthcare, and well-being. KEY RESULTS: By 6 months,1053 veterans had utilized WH and 3139 utilized only CC. Baseline pain PEG scores were 6.2 (2.5) for WH users and 6.4 (2.3) for CC users (difference p = 0.028), improving by - 2.4% (p = 0.006) and - 2.3% (p < 0.001), respectively. In adjusted analyses, WH use was unassociated with greater improvement in PEG scores compared to CC - 1.0% (- 2.9%, 1.2%). Positive trends were observed for 8 of 15 exploratory outcomes for WH compared to CC. WH use was associated with greater improvements at 6 months in likelihood to recommend VA 2.0% (0.9%, 3.3%); discussions of goals 11.8% (8.2%, 15.5%); perceptions of healthcare interactions 2.5% (0.4%, 4.6%); and engagement in health behaviors 2.2% (0.3%, 3.9%). CONCLUSION: This study provides early evidence supporting the delivery of WH patient-centered care services to improve veterans' experiences of and engagement in care. These are important first-line impacts towards the goals of better overall health and well-being outcomes for Veterans.

Pain Care Disparities and the Use of Virtual Care Among Racial-Ethnic Minority Groups During COVID-19.

BACKGROUND AND OBJECTIVE: COVID-19 led to an unprecedented reliance on virtual modalities to maintain care continuity for patients living with chronic pain. We examined whether there were disparities in virtual specialty pain care for racial-ethnic minority groups during COVID-19. DESIGN AND PARTICIPANTS: This was a retrospective national cohort study with two comparison groups: primary care patients with chronic pain seen immediately prior to COVID-19 (3/1/19-2/29/20) (N = 1,649,053) and a cohort of patients seen in the year prior (3/1/18-2/28-19; n = 1,536,954). MAIN MEASURES: We assessed use of telehealth (telephone or video) specialty pain care, in-person care specialty pain care, and any specialty pain care for both groups at 6 months following cohort inclusion. We used quasi-Poisson regressions to test associations between patient race and ethnicity and receipt of care. KEY RESULTS: Prior to COVID-19, there were Black-White (RR = 0.64, 95% CI [0.62, 0.67]) and Asian-White (RR = 0.63, 95% CI [0.54, 0.75]) disparities in telehealth use, and these lessened during COVID-19 (Black-White: RR = 0.75, 95% CI [0.73, 0.77], Asian-White: RR = 0.81, 95% CI [0.74, 0.89]) but did not disappear. Individuals identifying as American Indian/Alaska Native used telehealth less than White individuals during early COVID-19 (RR = 0.98, 95% CI [0.85, 1.13] to RR = 0.87, 95% CI [0.79, 0.96]). Hispanic/Latinx individuals were less likely than non-Hispanic/Latinx individuals to use telehealth prior to COVID-19 but more likely during early COVID-19 (RR = 0.70, 95% CI [0.66, 0.75] to RR = 1.06, 95% CI [1.02, 1.09]). Disparities in virtual pain care occurred over the backdrop of overall decreased specialty pain care during the early phase of the pandemic (raw decrease of n = 17,481 specialty care encounters overall from pre-COVID to COVID-era), including increased disparities in any VA specialty pain care for Black (RR = 0.81, 95% CI [0.80, 0.83] to RR = 0.79, 95% CI [0.77, 0.80]) and Asian (RR = 0.91, 95% CI [0.86, 0.97] to RR = 0.88, 95% CI [0.82, 0.94]) individuals. CONCLUSIONS: Disparities in virtual specialty pain care were smaller during the early phases of the COVID-19 pandemic than prior to the pandemic but did not disappear entirely, despite the rapid growth in telehealth. Targeted efforts to increase access to specialty pain care need to be concentrated among racial-ethnic minority groups.

VHA Whole Health Services and Complementary and Integrative Health Therapies: a Gateway to Evidence-Based Mental Health Treatment.

BACKGROUND: Engagement in evidence-based psychotherapy (EBP) among veterans with behavioral health conditions is often low. The Veterans Health Administration (VHA) is implementing a "Whole Health (WH)" system of care, to identify veteran personal health goals, align care with those goals, and offer services designed to engage and empower veterans to achieve well-being. OBJECTIVE: To examine the relationship between veteran WH utilization and subsequent engagement in EBP. DESIGN: Retrospective analysis of VHA administrative records from 18 facilities implementing WH. SUBJECTS: Veterans (n = 265,364) with a diagnosis of depression, post-traumatic stress disorder (PTSD), and/or anxiety who had a mental healthcare encounter but no EBP use in fiscal year (FY) 2018. Among this cohort, 33,146 (12.5%) began using WH in FY2019. MAIN MEASURES: We examined use of an EBP for depression, anxiety, and/or PTSD within 1 year of the index date of WH use compared to use of an EBP anytime during FY2019 for veterans not identified as using WH. We used multiple logistic regression to examine the association between veteran WH use and EBP engagement. KEY RESULTS: Approximately 3.0% (n = 7,860) of the veterans in our overall cohort engaged in an EBP in the year following their index date. Controlling for key demographic, health, and utilization variables, WH users had 2.4 (95% CI: 2.2-2.5) times higher odds of engaging in an EBP the following year than those with no WH utilization. Associations between utilization of specific WH services (vs. no utilization of that service) and engagement in an EBP in the subsequent year ranged from 1.6 (95% CI: 1.0-2.6) to 3.5 (95% CI: 3.2-3.9) across the different types of WH services used. CONCLUSIONS: WH use was associated with increased engagement in EBPs among veterans with depression, anxiety, and/or PTSD. Future interventions intended to promote veteran engagement in EBPs may benefit from leveraging WH services and therapies.

We Built it, But Did They Come: Veterans' Use of VA Healthcare System-Provided Complementary and Integrative Health Approaches.

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.

Telehealth Complementary and Integrative Health Therapies During COVID-19 at the U.S. Department of Veterans Affairs.

Background: Complementary and integrative health (CIH) therapies, such as in-person acupuncture, chiropractic care, and meditation, are evidence-based nonpharmaceutical treatment options for pain. During COVID-19, the Veterans Health Administration (VA) delivered several CIH therapies virtually. This study explores veterans' utilization, advantages/disadvantages, and delivery issues of yoga, Tai Chi, meditation/mindfulness (self-care), and massage, chiropractic, and acupuncture (practitioner-delivered care), using telephone/video at 18 VA sites during COVID-19. Methods: Use of virtual care was examined quantitatively with VA administrative data for six CIH therapies before and after COVID-19 onset (2019-2021). Advantages/disadvantages and health care delivery issues of these CIH therapies through virtual care were examined qualitatively using interview data (2020-2021). Results: Overall, televisits represented a substantial portion of all CIH self-care therapies delivered by VA in 2020 (53.7%) and 2021 (82.1%), as sites developed virtual group classes using VA secure online video platforms in response to COVID-19. In contrast, a small proportion of all encounters with acupuncturists, chiropractors, and massage therapists was telephone/video encounters in 2020 (17.3%) and in 2021 (5.4%). These were predominantly one-on-one care in the form of education, follow-ups, home exercises, assessments/evaluations, or acupressure. Delivery issues included technical difficulties, lack of access to needed technology, difficulty tracking virtual visits, and capacity restrictions. Advantages included increased access to self-care, increased patient receptivity to engaging in self-care, and flexibility in staffing online group classes. Disadvantages included patient preference, patient safety, and strain on staffing. Conclusion: Despite delivery issues or disadvantages of tele-CIH self-care, veterans' use of teleself-care CIH therapies grew substantially during the COVID-19 pandemic.

Receipt of Tobacco Treatment and One-Year Smoking Cessation Rates Following Lung Cancer Screening in the Veterans Health Administration.

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.

Telehealth and Rural-Urban Differences in Receipt of Pain Care in the Veterans Health Administration.

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.

Effectiveness of a whole health model of care emphasizing complementary and integrative health on reducing opioid use among patients with chronic pain.

BACKGROUND: The opioid crisis has necessitated new approaches to managing chronic pain. The Veterans Health Administration (VHA) Whole Health model of care, with its focus on patient empowerment and emphasis on nonpharmacological approaches to pain management, is a promising strategy for reducing patients' use of opioids. We aim to assess whether the VHA's Whole Health pilot program impacted longitudinal patterns of opioid utilization among patients with chronic musculoskeletal pain. METHODS: A cohort of 4,869 Veterans with chronic pain engaging in Whole Health services was compared with a cohort of 118,888 Veterans receiving conventional care. All patients were continuously enrolled in VHA care from 10/2017 through 3/2019 at the 18 VHA medical centers participating in the pilot program. Inverse probability of treatment weighting and multivariate analyses were used to adjust for observable differences in patient characteristics between exposures and conventional care. Patients exposed to Whole Health services were offered nine complementary and integrative health therapies alone or in combination with novel Whole Health services including goal-setting clinical encounters, Whole Health coaching, and personal health planning. MAIN MEASURES: The main measure was change over an 18-month period in prescribed opioid doses starting from the six-month period prior to qualifying exposure. RESULTS: Prescribed opioid doses decreased by -12.0% in one year among Veterans who began complementary and integrative health therapies compared to similar Veterans who used conventional care; -4.4% among Veterans who used only Whole Health services such as goal setting and coaching compared to conventional care, and -8.5% among Veterans who used both complementary and integrative health therapies combined with Whole Health services compared to conventional care. CONCLUSIONS: VHA's Whole Health national pilot program was associated with greater reductions in prescribed opioid doses compared to secular trends associated with conventional care, especially when Veterans were connected with complementary and integrative health therapies.

Performance of a rule-based semi-automated method to optimize chart abstraction for surveillance imaging among patients treated for non-small cell lung cancer.

BACKGROUND: We aim to develop and test performance of a semi-automated method (computerized query combined with manual review) for chart abstraction in the identification and characterization of surveillance radiology imaging for post-treatment non-small cell lung cancer patients. METHODS: A gold standard dataset consisting of 3011 radiology reports from 361 lung cancer patients treated at the Veterans Health Administration from 2008 to 2016 was manually created by an abstractor coding image type, image indication, and image findings. Computerized queries using a text search tool were performed to code reports. The primary endpoint of query performance was evaluated by sensitivity, positive predictive value (PPV), and F1 score. The secondary endpoint of efficiency compared semi-automated abstraction time to manual abstraction time using a separate dataset and the Wilcoxon rank-sum test. RESULTS: Query for image type demonstrated the highest sensitivity of 85%, PPV 95%, and F1 score 0.90. Query for image indication demonstrated sensitivity 72%, PPV 70%, and F1 score 0.71. The image findings queries ranged from sensitivity 75-85%, PPV 23-25%, and F1 score 0.36-0.37. Semi-automated abstraction with our best performing query (image type) improved abstraction times by 68% per patient compared to manual abstraction alone (from median 21.5 min (interquartile range 16.0) to 6.9 min (interquartile range 9.5), p < 0.005). CONCLUSIONS: Semi-automated abstraction using the best performing query of image type improved abstraction efficiency while preserving data accuracy. The computerized query acts as a pre-processing tool for manual abstraction by restricting effort to relevant images. Determining image indication and findings requires the addition of manual review for a semi-automatic abstraction approach in order to ensure data accuracy.

"There's a huge benefit just to know that someone cares:" a qualitative examination of rural veterans' experiences with TelePain.

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.

Does Offering Battlefield Acupuncture Lead to Subsequent Use of Traditional Acupuncture?

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<0.001). In adjusted analysis, accounting for patient characteristics and regional availability of traditional acupuncture, patients who used BFA had 10.9 times greater odds (95% confidence interval, 8.67-12.24) of subsequent traditional acupuncture use. CONCLUSIONS: Providing BFA, which is easy to administer during a patient visit and does not require providers be formally certified, led to a substantial increase in use of traditional acupuncture. These findings suggest that the value of offering BFA may not only be its immediate potential for pain relief but also subsequent engagement in additional therapies.

Patient Feedback on the Effectiveness of Auricular Acupuncture on Pain in Routine Clinical Care: The Experience of 11,406 Veterans.

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.

Overuse and Misuse of Inhaled Corticosteroids Among Veterans with COPD: a Cross-sectional Study Evaluating Targets for De-implementation.

BACKGROUND: 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). OBJECTIVE: To identify patients without identifiable indication for ICS and assess patient and provider characteristics associated with potentially inappropriate to targeted in de-implementation efforts DESIGN: We performed a cross-sectional study of patients with COPD in the Veterans Affairs (VA) system with recent spirometry. PARTICIPANTS: 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. MAIN MEASURES: ICS use without identifiable indication KEY RESULTS: We identified 26,536 patients with COPD without an identifiable indication for ICS. Nearly » 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. CONCLUSIONS: 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.

Assessing the Relative Effectiveness of Combining Self-Care with Practitioner-Delivered Complementary and Integrative Health Therapies to Improve Pain in a Pragmatic Trial.

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.

The APPROACH trial: Assessing pain, patient-reported outcomes, and complementary and integrative health.

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.

Lung Cancer Screening and Smoking Cessation Clinical Trials. SCALE (Smoking Cessation within the Context of Lung Cancer Screening) Collaboration.

National recommendations for lung cancer screening for former and current smokers aged 55-80 years with a 30-pack-year smoking history create demand to implement efficient and effective systems to offer smoking cessation on a large scale. These older, high-risk smokers differ from participants in past clinical trials of behavioral and pharmacologic interventions for tobacco dependence. There is a gap in knowledge about how best to design systems to extend reach and treatments to maximize smoking cessation in the context of lung cancer screening. Eight clinical trials, seven funded by the National Cancer Institute and one by the Veterans Health Administration, address this gap and form the SCALE (Smoking Cessation within the Context of Lung Cancer Screening) collaboration. This paper describes methodological issues related to the design of these clinical trials: clinical workflow, participant eligibility criteria, screening indication (baseline or annual repeat screen), assessment content, interest in stopping smoking, and treatment delivery method and dose, all of which will affect tobacco treatment outcomes. Tobacco interventions consider the "teachable moment" offered by lung cancer screening, how to incorporate positive and negative screening results, and coordination of smoking cessation treatment with clinical events associated with lung cancer screening. Unique data elements, such as perceived risk of lung cancer and costs of tobacco treatment, are of interest. Lung cancer screening presents a new and promising opportunity to reduce morbidity and mortality resulting from lung cancer that can be amplified by effective smoking cessation treatment. SCALE teamwork and collaboration promise to maximize knowledge gained from the clinical trials.

Challenges to Educating Smokers About Lung Cancer Screening: a Qualitative Study of Decision Making Experiences in Primary Care.

We sought to qualitatively explore how those at highest risk for lung cancer, current smokers, experienced, understood, and made decisions about participation in lung cancer screening (LCS) after being offered in the target setting for implementation, routine primary care visits. Thirty-seven current smokers were identified within 4 weeks of being offered LCS at seven sites participating in the Veterans Health Administration Clinical Demonstration Project and interviewed via telephone using semi-structured qualitative interviews. Transcripts were coded by two raters and analyzed thematically using iterative inductive content analysis. Five challenges to smokers' decision-making lead to overestimated benefits and minimized risks of LCS: fear of lung cancer fixated focus on inflated screening benefits; shame, regret, and low self-esteem stemming from continued smoking situated screening as less averse and more beneficial; screening was mistakenly believed to provide general evaluation of lungs and reassurance was sought about potential damage caused by smoking; decision-making was deferred to providers; and indifference about numerical educational information that was poorly understood. Biased understanding of risks and benefits was complicated by emotion-driven, uninformed decision-making. Emotional and cognitive biases may interfere with educating and supporting smokers' decision-making and may require interventions tailored for their unique needs.

Stakeholder Research Priorities for Smoking Cessation Interventions within Lung Cancer Screening Programs. An Official American Thoracic Society Research Statement.

RATIONALE: 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. OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: This statement offers an agenda to stimulate research surrounding the integration and implementation of smoking cessation interventions with LDCT lung cancer screening.

Exploring the role of physician communication about adjuvant endocrine therapy among breast cancer patients on active treatment: a qualitative analysis.

PURPOSE: To better understand how physicians communicate with breast cancer patients about adjuvant endocrine therapy (AET), we explored, from the breast cancer patient's perspective, dimensions of the patient-provider communication among women who were on active AET treatment. METHODS: Qualitative methods using semi-structured in-depth interviews were conducted with breast cancer patients (n = 22) who filled a prescription for AET in the previous 12 months. Interview questions aimed to elicit experiences with AET. We reviewed and coded interview transcripts using qualitative principles of inductive reasoning to identify concepts and themes from interview data. RESULTS: We grouped emergent themes into four major functions of physician-patient communication: (1) information exchange, (2) decision-making to take and continue AET, (3) enabling patient self-management and monitoring potential side effects, and (4) emotional support. Physicians exchanged information with patients in a way that they understood and enhanced patient's health literacy regarding the benefits and knowledge of AET. Physicians empowered patients to make decisions about their care. Patients expressed trust and confidence in their physician which helped them seek care when needed. Patients reported a high degree of self-efficacy to self-manage AET and were continuing treatment despite potential side effects. CONCLUSIONS: The results from our study suggest that women's interactions and communication with their physician may be an important factor that contributes to the continued use of AET. Physicians who can communicate information about AET treatment benefits, purpose, and expectations in a way that patients can understand is a critical aspect of care that needs to be further studied.