Research objectives and general considerations for pragmatic clinical trials of pain treatments: IMMPACT statement.

ABSTRACT: Many questions regarding the clinical management of people experiencing pain and related health policy decision-making may best be answered by pragmatic controlled trials. To generate clinically relevant and widely applicable findings, such trials aim to reproduce elements of routine clinical care or are embedded within clinical workflows. In contrast with traditional efficacy trials, pragmatic trials are intended to address a broader set of external validity questions critical for stakeholders (clinicians, healthcare leaders, policymakers, insurers, and patients) in considering the adoption and use of evidence-based treatments in daily clinical care. This article summarizes methodological considerations for pragmatic trials, mainly concerning methods of fundamental importance to the internal validity of trials. The relationship between these methods and common pragmatic trials methods and goals is considered, recognizing that the resulting trial designs are highly dependent on the specific research question under investigation. The basis of this statement was an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) systematic review of methods and a consensus meeting. The meeting was organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership. The consensus process was informed by expert presentations, panel and consensus discussions, and a preparatory systematic review. In the context of pragmatic trials of pain treatments, we present fundamental considerations for the planning phase of pragmatic trials, including the specification of trial objectives, the selection of adequate designs, and methods to enhance internal validity while maintaining the ability to answer pragmatic research questions.

A Pilot Study of a Screening Program for Human Papillomavirus-Related Squamous Intraepithelial Lesion and Malignancy in Gynecologic Oncology Patients.

OBJECTIVE: Human papillomavirus (HPV)-related squamous intraepithelial lesion (SIL) or malignancy is associated with a significantly increased risk of second-site SIL or malignancy. The primary objective of this study was to determine the feasibility and acceptability of concurrent anal, cervical, and vulvovaginal screening in patients with a history of HPV-related gynecologic high-grade SIL or malignancy. The secondary objective was to assess subjects' knowledge regarding HPV screening and risks. METHODS: Women with high-grade cervical, vulvar, or vaginal SIL or malignancy were enrolled during a 1-year pilot period. Subjects with cervical SIL or malignancy underwent vulvar examination and anoscopy. Subjects with vulvovaginal SIL or malignancy underwent Pap test if indicated and anoscopy. Appropriate referrals were made for abnormal findings. Feasibility was assessed by compliance using study acceptance rate, screening procedure adherence, and referral adherence. Acceptability was assessed using a Likert-scaled question after completion of screening procedures. RESULTS: One hundred three women with a diagnosis of high-grade vulvovaginal or cervical SIL or carcinoma were approached regarding study enrollment; of these, 74 (71.8%) enrolled. The median score on the HPV knowledge assessment was 8.1 ± 1.6 (max score 10). Seventy-three (98.6%) of 74 patients rated the screening procedures as acceptable (score of 5/5). On examination, 14 (18.9%) subjects had abnormalities noted; 7 (9.5%) were referred for colorectal surgical evaluation, and 6/7 (85.7%) were compliant with their referral appointments. CONCLUSIONS: Screening examinations for other HPV-related SILs and malignancies, including Pap tests, vulvovaginal inspection, and anoscopy, are acceptable to patients, with abnormal findings in almost 1 in 5 women.

Yoga Versus Education for Veterans with Chronic Low Back Pain: a Randomized Controlled Trial.

BACKGROUND: Yoga is effective for chronic low back pain (cLBP) in civilians but understudied among Veterans. OBJECTIVE: Determine whether yoga is more effective than an educational book for improving disability and pain among Veterans with cLBP. DESIGN, SETTING, AND PARTICIPANTS: Veterans diagnosed with cLBP at a VA medical center enrolled in a randomized controlled trial from March to December of 2015. INTERVENTIONS: Twelve weekly hatha yoga classes or education using The Back Pain Helpbook. MEASURES: Co-primary outcomes were changes from baseline at 12 weeks in back-related disability on the modified Roland Morris Disability Questionnaire and pain on the Defense & Veterans Pain Rating Scale. Secondary outcomes were global improvement, patient satisfaction, pain medication use, and post-traumatic stress symptoms. An intention-to-treat approach was used in primary analyses. RESULTS: One hundred twenty Veterans (mean age, 55.5 [SD = 16.9]; 11 [9%] women; mean number of chronic conditions, 5.5) were randomized to yoga (n = 62) and education (n = 58). At 12 weeks, reductions in back-related disability in yoga (mean difference [MD] = - 3.50, 95% CI: - 5.03, - 1.97) were not significantly different than education (MD = - 2.55, 95% CI: - 4.10, - 0.99; between-group difference: - 0.95 [95% CI: - 3.14, 1.23], p = 0.39). For pain, there was no significant difference between yoga (MD = - 1.01, 95% CI: - 1.67, - 0.35) and education (MD = - 0.81, 95% CI: - 1.36, - 0.27; between-group difference: - 0.20, 95% CI: - 1.06, 0.66, p = 0.65). More yoga than education participants reported being very much or extremely improved (39% vs 19%, OR = 3.71, 95% CI: 1.37, 10.02, p = 0.01) and very satisfied with treatment (60% vs 31%, OR = 4.28, 95% CI: 1.70, 10.77, p = 0.002). No differences in pain medication use or post-traumatic stress symptoms were observed at 12 weeks. No serious adverse events were reported in either group. CONCLUSION: Twelve weekly yoga classes were not more effective than an education intervention for improving pain or disability outcomes among mostly older male Veterans with cLBP and multiple comorbid health conditions. GOV IDENTIFIER: NCT02224183.

Moderators and Nonspecific Predictors of Treatment Benefits in a Randomized Trial of Mindfulness-Based Stress Reduction vs Cognitive-Behavioral Therapy vs Usual Care for Chronic Low Back Pain.

Both mindfulness-based stress reduction (MBSR) and cognitive-behavioral therapy (CBT) are effective for chronic low back pain (CLBP), but little is known regarding who might benefit more from one than the other. Using data from a randomized trial comparing MBSR, CBT, and usual care (UC) for adults aged 20 to 70 years with CLBP (N = 297), we examined baseline characteristics that moderated treatment effects or were associated with improvement regardless of treatment. Outcomes included 8-week function (modified Roland Disability Questionnaire), pain bothersomeness (0-10 numerical rating scale), and depression (Patient Health Questionnaire-8). There were differences in the effects of CBT versus MBSR on pain based on participant gender (P = .03) and baseline depressive symptoms (P = .01), but the only statistically significant moderator after Bonferroni correction was the nonjudging dimension of mindfulness. Scores on this measure moderated the effects of CBT versus MBSR on both function (P = .001) and pain (P = .04). Pain control beliefs (P <.001) and lower anxiety (P < .001) predicted improvement regardless of treatment. Replication of these findings is needed to guide treatment decision-making for CLBP. TRIAL REGISTRATION: The trial and analysis plan were preregistered in ClinicalTrials.gov (Identifier: NCT01467843). PERSPECTIVE: Although few potential moderators and nonspecific predictors of benefits from CBT or MBSR for CLBP were statistically significant after adjustment for multiple comparisons, these findings suggest potentially fruitful directions for confirmatory research while providing reassurance that patients could reasonably expect to benefit from either treatment.

Theory of Planned Behavior and Mindfulness Intentions in Chronic Low Back Pain.

Objectives: Theory of planned of behavior (TPB) constructs have been linked to health behavior intentions. Intentions to try mindfulness-based stress reduction (MBSR), a first-line therapy for chronic low back pain (cLBP), have been less studied. This study aimed to identify which TPB constructs could inform strategies to improve adoption of MBSR. Methods: People with cLBP (n = 457) read a description of MBSR then completed survey items assessing TPB constructs: attitudes, norms, self-efficacy, perceived control, and intentions to try MBSR training. Results: Structural equation modeling showed self-efficacy/control (coefficient: 0.564), norms (0.245), and attitudes (0.131) were all positively associated with intentions to try mindfulness trainings. Conclusions: Results suggest self-efficacy/control may be the most strongly related TPB construct with intentions to try MBSR. Dissemination of MBSR for cLBP could focus on adapting the intervention to increase accessibility and improving available resources to overcome logistical barriers (online formats, drop-in classes). Supplementary Information: The online version contains supplementary material available at 10.1007/s12671-022-02022-2.

Optimizing Narrowband UVB Phototherapy: Is It More Challenging for Your Older Patients?

Narrowband UVB (NB-UVB) phototherapy remains versatile, safe, and efficacious for multiple dermatologic conditions even with recent pharmacologic treatment advances. Polypharmacy contributes to prescribers pursuing phototherapy as a nonpharmacologic treatment, but some wonder if it is as effective and safe for older patients. This study aimed to determine if NB-UVB is equally effective in both older and younger adults treated with the same protocol and to examine the association between photosensitizing medications, clearance, and erythema rates in older vs younger adults.

An experimental study to inform adoption of mindfulness-based stress reduction in chronic low back pain.

BACKGROUND: Chronic low back pain is a common and sometimes disabling condition, and mindfulness-based stress reduction is recommended as a first line of therapy. This study tested whether different descriptions of mindfulness training altered based on influential intervention characteristics increased adoption intentions. METHODS: People with chronic low back pain (n = 452) were randomized to review one of four mindfulness training descriptions in an online survey using a 2 × 2 factorial design. The first factor was evidence strength and quality with relative advantage (ER). The second factor was adaptability, trialability, complexity, and design quality and packaging (AD). Each factor had two levels: a description of standardized mindfulness training that described each intervention characteristic and a patient-centered description emphasizing flexibility and patient testimonials. The primary outcomes were intentions to try mindfulness training and practice mindfulness at home. Using structural equation modeling with a bootstrapped distribution, we tested six mediators, three of which are Theory of Planned Behavior predictors of intention-self-efficacy, norms, and attitudes- and the other three are predictors of adoption-feasibility, appropriateness, and acceptability. RESULTS: Overall, the mindfulness training descriptions were not associated with an increase in intentions compared to the classic vignette (11/12 p's > 0.05). Most descriptions were unrelated to mediators except the classic ER with patient-centered AD was associated with higher self-efficacy/control and feasibility (p's ≤ 0.05; standardized effect range: 0.111-0.125). Self-efficacy/control (training standardized coefficient: 0.531, home: 0.686), norms (training: 0.303, home: 0.256), and attitudes (training: 0.316, home: 0.293) were all positively associated with intentions to adopt mindfulness training and home practice. Feasibility (training: 0.185; home: 0.293) and acceptability (training: 0.639; home: 0.554) were positively related to intentions to adopt mindfulness training. Appropriateness was related to intentions to adopt home practice (0.187) but not mindfulness training (0.100). None of the indirect effects from experimental group to intentions was significant (all p's > 0.05). CONCLUSIONS: Self-efficacy/control and acceptability may be key mediators for increasing patient adoption of mindfulness. Because experimental manipulation did not substantially change intentions to adopt mindfulness, the presentation and delivery of MBSR may need to be tailored to the individual patient's needs rather than a specific format for chronic low back pain.

"In Class We Were All One." A Qualitative Exploration of Yoga and Educational Interventions for Predominantly Low-Income and Minority Adults with Chronic Low Back Pain.

Introduction: Chronic low back pain (cLBP) can be physically and psychologically debilitating and disproportionally afflicts vulnerable populations. Yoga and education are increasingly common interventions for cLBP yet are understudied in low-income and minority adults. The objective of this qualitative study was to understand the yoga and self-care experience of adults with cLBP from urban, underserved communities who were enrolled in a randomized controlled trial that included these treatments. Methods: We interviewed 26 (18 yoga and 8 education) participants. Interviews were transcribed verbatim and analyzed using thematic analysis with codes developed inductively from data. Results: Participants from both yoga and education groups reported initial apprehension and ambivalence toward their respective intervention. However, physical and psychological benefits were noted, mainly in the form of improved pain self-management. Communal support and camaraderie reported by the yoga group was absent and desired by education participants. Social factors impeding the ability to sustain yoga practice included transportation, access, and cost, whereas education participants described literacy and language challenges and a general lack of motivation to read the book. Conclusion: Yoga and education are viable treatments for adults with cLBP who live in underserved neighborhoods. However, social stigma and socioeconomic barriers may hinder their uptake. Communal support in group-based nonpharmacological treatments is valued and may contribute to participation and clinical outcomes. ClinicalTrials.gov Identifier: NCT01343927.

Do Physical Therapy and Yoga Improve Pain and Disability through Psychological Mechanisms? A Causal Mediation Analysis of Adults with Chronic Low Back Pain.

OBJECTIVE: To investigate whether indirect effects via psychological mechanisms explain the effects of physical therapy (PT) or yoga versus education on back-related outcomes. DESIGN: Mediation analyses using data from a randomized controlled trial of PT, yoga, and education interventions for chronic low back pain. METHODS: Primary outcomes were changes in back-related pain on the 11-point numeric rating scale and disability on the modified 23-point Roland-Morris Disability Questionnaire, measured at 52 weeks after randomization. Hypothesized mediators were 12-week changes in pain self-efficacy, fear-avoidance beliefs, depression, anxiety, perceived stress, and sleep quality. We used causal mediation analysis to estimate the total effect, direct effect, indirect effect, and proportion mediated. RESULTS: We analyzed data from 230 adults (mean age = 46.2 years, 69.6% female, 79.6% non-White). In the PT-versus-education model, when the mediator was perceived stress, the total effect on disability was 2.6 points (95% confidence interval [CI]: 0.3, 4.9) and decomposed into a direct effect of 1.7 points (95% CI: -0.4, 3.8) and an indirect effect 0.9 points (95% CI: 0.1, 2.0; proportion mediated, 34%). No other psychological construct was a significant mediator. CONCLUSION: Improvements in perceived stress mediated improvements in disability after PT treatment compared to education. Other psychological outcomes did not mediate the effect of yoga or PT on pain or disability outcomes compared to education. J Orthop Sports Phys Ther 2022;52(7):470-483. Epub: 18 May 2022. doi:10.2519/jospt.2022.10813.

An Exploratory Randomized Controlled Trial of a 12-Week Yoga Versus Educational Film Program for the Management of Restless Legs Syndrome: Feasibility and Acceptability.

Objectives: The primary objectives of this pilot trial were to assess the study feasibility and acceptability of the 12-week yoga and educational film programs for the management of restless legs syndrome (RLS) in preparation for a future randomized controlled trial (RCT). Materials and Methods: This pilot, parallel-arm, randomized feasibility trial was conducted at two sites, Morgantown, WV and Columbus, OH. Yoga group participants attended 75-min Iyengar yoga classes, twice weekly for 4 weeks, then once a week for 8 weeks (16 total classes), and completed a 30-min homework routine on nonclass days. Educational film group participants attended once weekly, 75-min classes (12 total classes), which included information on RLS and other sleep disorders, RLS management including sleep hygiene practices, and complementary therapies. Feasibility and acceptability outcomes included program satisfaction and recruitment, retention, and adherence rates. In addition, participants were asked their preferences regarding three yoga class schedule scenarios for a future study. Attendance, yoga, and treatment logs were collected weekly. Program evaluation and yoga scheduling questionnaires were collected at week 12. Results: Forty-one adults with moderate to severe RLS were randomized to a 12-week yoga (n = 19) or educational film (n = 22) program. Thirty participants (73%) completed the program. Yoga and education group participants attended an average of 13.0 ± 0.84 (81%) and 10.3 ± 0.3 classes (85%), respectively. Participants from both groups indicated satisfaction with the study. All yoga group respondents to the program evaluation reported they would likely (n = 6) or very likely (n = 7) continue yoga practice; 86.7% of education group respondents (13 of 15) indicated that they were likely (n = 7) or very likely (n = 6) to make lasting changes based on what they had learned. The preferred schedule for a future study was a 16-week study with once-weekly yoga classes. Conclusions: The findings of this study suggest that a larger RCT comparing yoga with an educational film group for the management of RLS is feasible. Trial registration: Clinicaltrials.gov: NCT03570515; 02/01/2017.

Interest in Mindfulness Training for Chronic Low-Back Pain: Results from a Vignette-driven, Web-based Survey of Patients.

Objectives: Mindfulness-based stress reduction (MBSR) has been found effective for improving chronic low-back pain (cLBP). However, little data exist regarding how attractive this technique is to Americans as a therapy for cLBP. Design: Survey of randomly selected persons with cLBP. Settings/Location: Respondents were recruited from Kaiser Permanente Washington and one-time surveys were completed online. Patients: Adults 18-80 years of age with cLBP. Surveys: The study was conducted between December 2019 and August 2020. Outcome measures: The survey described an evidence-based classic MBSR course and then asked respondents about their sociodemographic characteristics, their current back pain, previous back pain treatments, behavioral risk factors for back pain, and four outcomes indicative of intention to engage in MBSR. Results: Four-hundred fifty-seven respondents completed the survey. Respondents were primarily women, white, educated, and with back pain for more than 5 years. About half had previously used a mind-body therapy for their pain. Overall, they reported moderate to high intention to try mindfulness classes and practice at home (median of 5 with 50% of the observations between 4 and 6, and 5.7, 50% of the observations between 4.3 and 6.3, respectively, on a 7-point scale). They reported a willingness to spend a median of 3 h/week learning mindfulness and 3.5 h/week practicing mindfulness techniques (for both outcomes, 50% of the respondents reported between 2 and 5 h). Few patient characteristics predicted intention to engage in MBSR, with no variable predicting all outcomes. The magnitude of the effect associated with significant predictors was small. Conclusion: Classic MBSR appealed to many survey respondents, in that they reported high interest in learning MBSR and intention to practice at home. The amount of time they reported being willing to spend learning MBSR and practicing at home is consistent with the time commitment in the original course.

Changes in Pain Self-Efficacy, Coping Skills, and Fear-Avoidance Beliefs in a Randomized Controlled Trial of Yoga, Physical Therapy, and Education for Chronic Low Back Pain.

OBJECTIVE: We evaluated exercise interventions for cognitive appraisal of chronic low back pain (cLBP) in an underserved population. METHODS: We conducted a secondary analysis of the Back to Health Trial, showing yoga to be noninferior to physical therapy (PT) for pain and function outcomes among adults with cLBP (n = 320) recruited from primary care clinics with predominantly low-income patients. Participants were randomized to 12 weeks of yoga, PT, or education. Cognitive appraisal was assessed with the Pain Self-Efficacy Questionnaire (PSEQ), Coping Strategies Questionnaire (CSQ), and Fear-Avoidance Beliefs Questionnaire (FABQ). Using multiple imputation and linear regression, we estimated within- and between-group changes in cognitive appraisal at 12 and 52 weeks, with baseline and the education group as references. RESULTS: Participants (mean age = 46 years) were majority female (64%) and majority Black (57%), and 54% had an annual household income <$30,000. All three groups showed improvements in PSEQ (range 0-60) at 12 weeks (yoga, mean difference [MD] = 7.0, 95% confidence interval [CI]: 4.9, 9.0; PT, MD = 6.9, 95% CI: 4.7 to 9.1; and education, MD = 3.4, 95% CI: 0.54 to 6.3), with yoga and PT improvements being clinically meaningful. At 12 weeks, improvements in catastrophizing (CSQ, range 0-36) were largest in the yoga and PT groups (MD = -3.0, 95% CI: -4.4 to -1.6; MD = -2.7, 95% CI: -4.2 to -1.2, respectively). Changes in FABQ were small. No statistically significant between-group differences were observed on PSEQ, CSQ, or FABQ at either time point. Many of the changes observed at 12 weeks were sustained at 52 weeks. CONCLUSION: All three interventions were associated with improvements in self-efficacy and catastrophizing among low-income, racially diverse adults with cLBP. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01343927.

Patient, Provider, and Clinic Characteristics Associated with Opioid and Non-Opioid Pain Prescriptions for Patients Receiving Low Back Imaging in Primary Care.

BACKGROUND: To describe characteristics of patients, providers, and clinics associated with opioid or non-opioid pain medication prescribing patterns for patients who received lower spine imaging in primary care clinics. METHODS: In these secondary analyses of the Lumbar Imaging with Reporting of Epidemiology (LIRE) study, a randomized controlled trial conducted in 4 health systems in the United States, we evaluated characteristics associated with receipt of pain medication prescriptions. The outcomes were receipt of prescriptions for opioid or, separately, non-opioid pain medications within 90 days after imaging. Among patients who received opioid or non-opioid prescriptions, we evaluated receipt of multiple prescriptions in the year following imaging. Mixed models were used to estimate adjusted odds ratios (ORs) and 95% confidence intervals (CIs). RESULTS: Compared with whites, patients identified as Asian (OR, 0.53; 95% CI, 0.51-0.56), Native Hawaiian/Pacific Islander (OR, 0.73; 95% CI, 0.64-0.83), multiracial (OR, 0.84; 95% CI, 0.71-0.98) or Black (OR, 0.92; 95% CI, 0.89-0.96) had significantly reduced odds for receiving prescriptions for opioids within 90 days. Patients identified as Native American/Alaska Native had greater odds for receiving prescriptions for non-opioid pain medications within 90 days (OR, 1.12; 95% CI, 1.01-1.24). Receipt of pain prescriptions 120 days before imaging was strongly predictive of subsequent receipt of pain prescriptions across all categories. CONCLUSIONS: After adjusting for factors that could affect prescribing, the strongest differences observed in pain-medication prescribing were across racial categories and for patients with previous pain prescriptions. Further research is needed to understand these differences and to optimize prescribing.

Expected Organizational Costs for Inserting Prevalence Information Into Lumbar Spine Imaging Reports.

BACKGROUND: Modifying physician behavior to more closely align with guideline-based care can be challenging. Few effective strategies resulting in appropriate spine-related health care have been reported. The Lumbar Imaging With Reporting of Epidemiology (LIRE) intervention did not result in reductions in spine care but did in opioid prescriptions written. OBJECTIVES: To estimate organizational resource needs and costs associated with implementing a pragmatic, decision support-type intervention that inserted age- and modality-matched prevalence information for common lumbar spine imaging findings, using site-based resource use data from the LIRE trial. RESEARCH DESIGN: Time and cost estimation associated with implementing the LIRE intervention in a health organization. SUBJECTS: Providers and patients assessed in the LIRE trial. MEASURES: Expected personnel costs required to implement the LIRE intervention. RESULTS: Annual salaries were converted to daily average per person costs, ranging from $400 to $2,200 per day (base case) for personnel (range: $300-$2,600). Estimated total average cost for implementing LIRE was $5,009 (range: $2,651-$12,020), including conducting pilot testing with providers. Costs associated with a small amount of time for a radiologist (6-12 hours) and imaging-ordering providers (1-8 hours each) account for approximately 75% of the estimated total cost. CONCLUSIONS: The process of implementing an intervention for lumbar spine imaging reports containing age- and modality-appropriate epidemiological benchmarks for common imaging findings required radiologists, imaging-ordering providers, information technology specialists, and limited testing and monitoring. The LIRE intervention seems to be a relatively low-cost, evidence-based, complementary tool that can be easily integrated into the reporting of spine imaging.

Translation, Cross-Cultural Adaptation, and Psychometric Validation of the English Version of the Postural Awareness Scale.

PURPOSE: The Postural Awareness Scale (PAS) was developed among a sample of German speakers to measure self-reported awareness of body posture. The first aim of this study was to conduct an English translation and cross-cultural adaptation of the PAS. The second aim was to assess psychometric properties of the English version of the PAS. METHODS: Forward and backward translations were conducted. The translated scale was then pretested in a small sample of English-speaking adults (n = 30), followed by cognitive interviews. Finally, consensus of the translated scale was achieved among an expert committee (n = 5), resulting in the Postural Awareness Scale-English Version (PAS-E). Psychometric properties of the PAS-E were investigated among a sample of individuals with chronic pain (n = 301) by evaluating factor structure, reliability, and construct validity. Analyses of variance were conducted to calculate differences in PAS-E scores between specific subgroups (pain conditions, sex, and history of mindfulness practice). Linear regression analyses investigated whether the scores on the PAS-E predicted levels of pain, stress, and mood. RESULTS: The results obtained from an exploratory factor analysis showed a two-factor solution and were supported by a confirmatory factor analysis. The scale demonstrated good internal consistency and satisfactory construct validity. No significant differences related to sex at birth or pain duration were found. CONCLUSION: PAS-E demonstrated good psychometric properties, and therefore, can and should be used both for research and clinical practice.

The Intersection of Dissemination Research and Acupuncture: Applications for Chronic Low Back Pain.

Dissemination research is the study of distributing information and intervention materials to a specific clinical practice or public health audience. Acupuncture, a healthcare practice involving the stimulation of certain body points, often with thin needles, is considered an evidence-based treatment for low back pain (LBP), but is underutilized in the United States. Body: We will use the example of acupuncture for LBP to identify opportunities to leverage dissemination research to increase utilization of acupuncture. Deficits in the awareness or knowledge of acupuncture may limit its adoption by patients and other stakeholders. Thus, we summarize methods to gather data on stakeholder awareness and knowledge of acupuncture for LBP, i.e., audience research. Engaging multiple stakeholder audiences (e.g., health system leaders, primary care providers, patients), is needed to generate knowledge on promising dissemination strategies for each audience. Audience segmentation is important for identifying population subgroups for whom adoption of acupuncture may require a more intensive or tailored dissemination strategy. To illustrate potential audience 'segments', our research discussion focused on developing dissemination strategies by age (i.e., older adults - those age 65 years or older, and younger adults - those under age 65 ). This decision was prompted by Medicare's recent policy covering acupuncture for chronic LBP. We leverage current knowledge of barriers and facilitators of acupuncture use to discuss how further tailoring of dissemination strategies might optimize adoption of acupuncture in both groups of adults. Experimental study designs could then be used to compare the effectiveness of such strategies to increase awareness, knowledge, or adoption of acupuncture. Conclusions: Conducting dissemination research may improve awareness and knowledge of acupuncture, and ultimately the adoption of acupuncture in biomedical settings. We anticipate that the concepts highlighted in this manuscript will also be helpful for those disseminating information about other complementary and integrative health approaches.

Acupuncture Intervention Protocol: Consensus Process for a Pragmatic Randomized Controlled Trial of Acupuncture for Management of Chronic Low Back Pain in Older Adults: An NIH HEAL Initiative Funded Project.

OBJECTIVE: The aim of this article is to describe the consensus process used to develop an acupuncture intervention protocol for an NIH-funded pragmatic randomized controlled trial (PRCT) of acupuncture for the management of chronic low back (cLBP) in older adults (BackInAction). BACKGROUND: CLBP is among leading causes of disability worldwide: almost 33% of US adults 65 and older experience LBP. Acupuncture is effective for cLBP but there is no specific data on older adults. The National Institutes for Health (NIH) funded a PRCT of acupuncture needling for this population. An essential trial milestone was development of a consensus intervention protocol. METHODS: An Acupuncture Advisory Panel (AAP) was formed with nine members: two physician-acupuncturists, six licensed acupuncturists representing diverse work backgrounds, and an acupuncture researcher. We used a modified Delphi process that included provision of acupuncture trial data, survey data describing how each expert treats cLBP, three conference calls, and between-call email discussion. RESULTS: Lively and professional discussions led to a consensus intervention protocol for the BackInAction trial that included steps/staging of care, recommendations for parameters of care session length, number of needle insertion sites, insertion depths, needle retention times, recommended types of needles, both local and distal areas of the body to be treated, acupuncture point options, auricular point options, self-care options, and minimum number of sessions considered ideal. CONCLUSION: Using a modified Delphi process, an expert AAP created a consensus intervention protocol for the PRCT of acupuncture needling for cLBP in patients 65 and older.