Comparison of erector spinae and gluteus medius muscle thickness and activation in individuals with and without low back pain.

BACKGROUND: Dysfunctional patterns of the erector spinae (ES) and gluteus medius (GM) muscles often accompany episodes of low back pain (LBP). Rehabilitative ultrasound imaging (RUSI) has been used to measure ES and GM muscle thickness, however such measurements have not been compared in individuals with and without LBP. OBJECTIVES: To compare ES and GM muscle thickness and change in thickness utilizing RUSI in individuals with and without LBP. DESIGN: Cross-sectional comparison. METHODS: A volunteer sample of 60 adults with (n = 30) and without (n = 30) LBP was examined. Thickness measurements of the ES and GM at rest and during contraction were obtained by using RUSI during a single session. Statistical comparison was performed using ANCOVA. The demographic variable age was used as a covariate in the primary comparative analysis. RESULTS: Mean difference for age between groups was 5.4 years (95% CI: 1.85, 8.94, p = 0.004). Average ODI score was 32.33±6.58 and pain level of 5.39±0.73 over the last 24 h in the symptomatic group. There was a statistically significant difference in the percent thickness change in both the ES, mean difference = -3.46 (95% CI: -6.71, -0.21, p = 0.039) and GM, mean difference = -1.93 (95% CI: -3.85, -0.01, p = 0.049) muscles between groups. CONCLUSIONS: Individuals with LBP may have reduced percent thickness change of the ES and GM muscles when compared to asymptomatic individuals.

Telehealth delivery of physical therapist-led interventions for persons with chronic low back pain in underserved communities: lessons from pragmatic clinical trials.

In this perspective, we present our experience developing and conducting two pragmatic clinical trials investigating physical therapist-led telehealth strategies for persons with chronic low back pain. Both trials, the BeatPain Utah and AIM-Back trials, are part of pragmatic clinical trial collaboratories and are being conducted with persons from communities that experience pain management disparities. Practice guidelines recommend nonpharmacologic care, and advise against opioid therapy, for the primary care management of persons with chronic low back pain. Gaps between these recommendations and actual practice patterns are pervasive, particularly for persons from racial or ethnic minoritized communities, those with fewer economic resources, and those living in rural areas including Veterans. Access barriers to evidence-based nonpharmacologic care, which is often provided by physical therapists, have contributed to these evidence-practice gaps. Telehealth delivery has created new opportunities to overcome access barriers for nonpharmacologic pain care. As a relatively new delivery mode however, telehealth delivery of physical therapy comes with additional challenges related to technology, intervention adaptations and cultural competence. The purpose of this article is to describe the challenges encountered when implementing telehealth physical therapy programs for persons with chronic low back pain in historically underserved communities. We also discuss strategies developed to overcome barriers in an effort to improve access to telehealth physical therapy and reduce pain management disparities. Inclusion of diverse and under-represented communities in pragmatic clinical trials is a critical consideration for improving disparities, but the unique circumstances present in these communities must be considered when developing implementation strategies.

Understanding social determinants of health and physical therapy outcomes in patients with low back pain: A scoping review.

BACKGROUND: Low back pain (LBP) is the number one cause of disability worldwide; however, it is not clear how social determinants of health (SDOH) impact care management and outcomes related to physical therapy (PT) services for patients with LBP. OBJECTIVE: The purposes of this scoping review are to examine and assimilate the literature on how SDOH and PT care relate to non-specific LBP outcomes and identify gaps in the literature to target for future research. METHODS: Data were extracted from eight electronic databases from January 2011 to February 2022. Reviewers independently screened all studies using the PRISMA extension for scoping review guidelines. Data related to study design, type of PT, type of non-specific LBP, patient demographics, PT intervention, SDOH, and PT outcomes were extracted from the articles. RESULTS: A total of 30,523 studies were screened, with 1961 articles undergoing full text review. Ultimately, 76 articles were identified for inclusion. Sex and age were the most frequent SDOH examined (88% and 78% respectively) followed by education level (18%). Approximately half of the studies that examined age, sex, and education level identified no effect on outcomes. The number of studies examining other factors was small and the types of outcomes evaluated were variable, which limited the ability to pool results. CONCLUSIONS: Sex and age were the most frequent SDOH examined followed by education level. Other factors were evaluated less frequently, making it difficult to draw conclusions. Study design and heterogeneity of determinants and outcomes were barriers to examining the potential impact on patients with LBP.

The Development of an Opioid Misuse Training Program for Physical Therapists: A Learning Community Approach.

INTRODUCTION: Musculoskeletal pain and opioid misuse frequently co-occur. REVIEW OF THE LITERATURE: The US Preventive Services Task Force calls for all health care providers to be trained to screen for misuse and/or opioid use disorder. The purpose of this study was to develop and implement an opioid misuse training program that could be used by physical therapists. SUBJECTS: Thirteen practicing physical therapists were invited to participate in a curriculum development project. METHODS: Using the Curriculum Framework, a collaborative learning approach was used to develop an opioid misuse training program and training manual for physical therapists. Four training sessions were provided virtually every 2 weeks. Topics included an introduction to the opioid crisis, screening, assessing, and communicating with patients and with the health care team about opioid misuse. Each didactic session was followed by a participant feedback session where participants provided recommendations on improving the training content and their impressions on the barriers and facilitators to incorporating the training into practice. A companion training manual was created and sent to participants for comment. Participants were asked over email to describe whether and how they incorporated training materials into clinical practice during the training curriculum. RESULTS: All participants attended sessions 1-3. Twelve (92.3%) attended the fourth session. Based on the participants' feedback, training sessions were edited, and a companion training manual was finalized and distributed to each participant. After the fourth session, 9 participants (69.2%) reported using what they learned in the training. During the participant feedback sessions, participants regarded the training as important. Some participants expressed barriers to discussing opioids with patients and concerns about whether the training was within physical therapists' scope of practice. DISCUSSION AND CONCLUSION: An iteratively developed training program for physical therapists to address opioid misuse was acceptable, feasible, and provided immediate practice change by most participants.

Developing an international consensus Reporting guideline for intervention Fidelity in Non-Drug, non-surgical trials: The ReFiND protocol.

BACKGROUND: Inadequate reporting of fidelity to interventions in trials limits the transparency and interpretation of trial findings. Despite this, most trials of non-drug, non-surgical interventions lack comprehensive reporting of fidelity. If fidelity is poorly reported, it is unclear which intervention components were tested or implemented within the trial, which also hinders research reproducibility. This protocol describes the development process of a reporting guideline for fidelity of non-drug, non-surgical interventions (ReFiND) in the context of trials. METHODS: The ReFiND guideline will be developed in six stages. Stage one: a guideline development group has been formed to oversee the guideline methodology. Stage two: a scoping review will be conducted to identify and summarize existing guidance documents on the fidelity of non-drug, non-surgical interventions. Stage three: a Delphi study will be conducted to reach consensus on reporting items. Stage four: a consensus meeting will be held to consolidate the reporting items and discuss the wording and structure of the guideline. Stage five: a guidance statement, an elaboration and explanation document, and a reporting checklist will be developed. Stage six: different strategies will be used to disseminate and implement the ReFiND guideline. DISCUSSION: The ReFiND guideline will provide a set of items developed through international consensus to improve the reporting of intervention fidelity in trials of non-drug, non-surgical interventions. This reporting guideline will enhance transparency and reproducibility in future non-drug, non-surgical intervention research.

The Effect of Combining Spinal Manipulation and Dry Needling in Individuals With Nonspecific Low Back Pain.

Low back pain (LBP) is one of the most common and costly musculoskeletal conditions impacting health care in the United States. The development of multimodal strategies of treatment is imperative in order to curb the growing incidence and prevalence of LBP. Spinal manipulative therapy (SMT), dry needling (DN), and exercise are common nonpharmacological treatments for LBP. This study is a 3-armed parallel-group design randomized clinical trial. We enrolled and randomized 96 participants with LBP into a multimodal strategy of treatment consisting of a combination of DN and SMT, DN only, and SMT only, followed by an at-home exercise program. All participants received 4 treatment sessions in the first 2 weeks followed by a 2-week home exercise program. Outcomes included clinical (Oswestry Disability Index, numeric pain intensity rating) and mechanistic (lumbar multifidus, erector spinae, and gluteus medius muscle activation) measures at baseline, 2, and 4 weeks. Participants in the DN and SMT groups showed larger effects and statistically significant improvement in pain and disability scores, and muscle percent thickness change at 2 weeks and 4 weeks of treatment when compared to the other groups. This study was registered prior to participant enrollment. PERSPECTIVE: This article presents the process of developing an optimized multimodal treatment plan utilizing SMT, DN, and exercise to address the burden of LBP for impacted individuals and the health care system. This method could potentially help clinicians who treat LBP to lower initial pain and increase exercise compliance. (clinicaltrials.gov NCT05802901).

Trends in Telerehabilitation Utilization in the United States 2020-2021.

OBJECTIVE: To examine telerehabilitation utilization in the United States (US) during the first 2 years of the pandemic. DESIGN: We performed a retrospective analysis of outpatient insurance claims from the IBM MarketScan Commercial Claims and Encounters Database to identify the number and proportion of patients using telerehabilitation from 2020 to 2021. Telerehabilitation was identified based on the presence of specific code modifiers and place of service. SETTING: Retrospective claims analysis. PARTICIPANTS: Individuals living in the United States with employer-sponsored insurance plans using outpatient physical or occupational therapy (PT/OT) (N=2,007,524). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: Number and proportion of outpatient PT/OT visits completed via telerehabilitation. RESULTS: We identified 21,026,608 PT/OT visits among 2,007,524 patients. Overall, 49,974 (2.5%) patients received ≥1 telerehabilitation visit during the specified timeframe. We observed trends in utilization over time, with utilization peaking in April 2020 when 10.9% of all PT/OT visits were conducted by telerehabilitation. We also observed geographic trends with lower rates of utilization identified in rural areas. State-by-state utilization rates ranged from 10.4% (California) to 0.3% (Wyoming). CONCLUSION: Telerehabilitation may be underutilized as a means of improving access to PT/OT, especially in rural areas of the country. Further research is needed to examine contributing factors to low observed utilization rates, such as provider and patient perceptions of telerehabilitation.

Disparities in Provider Ordering Practices of Image-Guided Interventions and Surgery for Patients With Low Back Pain: A Cohort Study.

OBJECTIVE: To assess individual- and neighborhood-level sociodemographic factors associating with providers' ordering of nonpharmacologic treatments for patients with low back pain (LBP), specifically physical therapy, image-guided interventions, and lumbar surgery. METHODS: Our cohort included all patients diagnosed with LBP from 2000 to 2017 in a statewide database of all hospitals and ambulatory surgical facilities within Utah. We compared sociodemographic and clinical characteristics of (1) patients with LBP who received any treatment with those who received none and (2) patients with LBP who received invasive LBP treatments with those who only received noninvasive LBP treatments using the Student's t test, Wilcoxon's rank-sum tests, and Pearson's χ2 tests, as applicable, and two separate multivariate logistic regression models: (1) to determine whether sociodemographic characteristics were risk factors for receiving any LBP treatments and (2) risk factors for receiving invasive LBP treatments. RESULTS: Individuals in the most disadvantaged neighborhoods were less likely to receive any nonpharmacologic treatment orders (odds ratio [OR] 0.74 for most disadvantaged, P < .001) and received fewer invasive therapies (0.92, P = .018). Individual-level characteristics correlating with lower rates of treatment orders were female sex, Native Hawaiian or other Pacific Islander race (OR 0.50, P < .001), Hispanic ethnicity (OR 0.77, P < .001), single or unmarried status (OR 0.69, P < .001), and no insurance or self-pay (OR 0.07, P < .001). CONCLUSION: Neighborhood and individual sociodemographic variables associated with treatment orders for LBP with Area Deprivation Index, sex, race or ethnicity, insurance, and marital status associating with receipt of any treatment, as well as more invasive image-guided interventions and surgery.

Use of implementation mapping in the planning of a hybrid type 1 pragmatic clinical trial: the BeatPain Utah study.

BACKGROUND: Considerable disparities in chronic pain management have been identified. Persons in rural, lower income, and minoritized communities are less likely to receive evidence-based, nonpharmacologic care. Telehealth delivery of nonpharmacologic, evidence-based interventions for persons with chronic pain is a promising strategy to lessen disparities, but implementation comes with many challenges. The BeatPain Utah study is a hybrid type 1 effectiveness-implementation pragmatic clinical trial investigating telehealth strategies to provide nonpharmacologic care from physical therapists to persons with chronic back pain receiving care in ommunity health centers (CHCs). CHCs provide primary care to all persons regardless of ability to pay. This paper outlines the use of implementation mapping to develop a multifaceted implementation plan for the BeatPain study. METHODS: During a planning year for the BeatPain trial, we developed a comprehensive logic model including the five-step implementation mapping process informed by additional frameworks and theories. The five iterative implementation mapping steps were addressed in the planning year: (1) conduct needs assessments for involved groups; (2) identify implementation outcomes, performance objectives, and determinants; (3) select implementation strategies; (4) produce implementation protocols and materials; and (5) evaluate implementation outcomes. RESULTS: CHC leadership/providers, patients, and physical therapists were identified as involved groups. Barriers and assets were identified across groups which informed identification of performance objectives necessary to implement two key processes: (1) electronic referral of patients with back pain in CHC clinics to the BeatPain team and (2) connecting patients with physical therapists providing telehealth. Determinants of the performance objectives for each group informed our choice of implementation strategies which focused on training, education, clinician support, and tailoring physical therapy interventions for telehealth delivery and cultural competency. We selected implementation outcomes for the BeatPain trial to evaluate the success of our implementation strategies. CONCLUSIONS: Implementation mapping provided a comprehensive and systematic approach to develop an implementation plan during the planning phase for our ongoing hybrid effectiveness-implementation trial. We will be able to evaluate the implementation strategies used in the BeatPain Utah study to inform future efforts to implement telehealth delivery of evidence-based pain care in CHCs and other settings. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04923334 . Registered June 11, 2021.

Differences in Pain Experience Among Different Racial and Ethnic Groups.

OBJECTIVE: The objective of this study was to examine the role of pain catastrophizing and pain self-efficacy as possible mediators of race-based differences in pain intensity, and to evaluate the possible moderating role of race on the relationship between pain catastrophizing and pain self-efficacy with pain outcomes among persons with chronic spinal pain receiving physical therapy. METHODS: This study was a secondary analysis of a cluster-randomized trial. Participants were persons with chronic spinal pain in outpatient physical therapy clinics who consented to complete assessments at baseline and after 2 weeks and 12 weeks. Assessments included pain intensity, physical function, pain catastrophizing, and self-efficacy. Baseline comparisons between Black and non-Hispanic White participants were made. Mediation analyses used a regression-based framework to examine whether baseline pain catastrophizing and self-efficacy mediated the association between race and pain intensity. Moderation analyses used multiple linear regression to evaluate the role of race in the relationship of baseline pain catastrophizing and self-efficacy with 12-week pain intensity outcomes. RESULTS: A total of 274 participants were included (51 [18.6%] Black and 223 [81.4%] non-Hispanic White; mean age = 51.6 years [SD = 14.9]; 180 [65.7%] female). At baseline, Black participants had higher pain intensity scores (mean difference = 0.80; 95% CI = 1.5 to 0.12). Both pain catastrophizing and self-efficacy mediated the relationship between race and baseline pain intensity. Race moderated the relationships between baseline pain catastrophizing and self-efficacy and 12-week pain intensity scores. CONCLUSION: Pain catastrophizing and self-efficacy had differential impacts on pain intensity based on race for both cross-sectional and longitudinal analyses among persons receiving physical therapy for chronic spinal pain. IMPACT: Improved understanding of the differences in pain experience based on factors such as race, ethnicity, cultural background, and experience with the health care system may help reduce disparities in pain management.

Examining the Relationship Between Individual Patient Factors and Substantial Clinical Benefit From Telerehabilitation Among Patients With Chronic Low Back Pain.

OBJECTIVE: The coronavirus disease-2019 pandemic has facilitated the emergence of telerehabilitation, but it is unclear which patients are most likely to respond to physical therapy provided this way. The purpose of this study was to examine the relationship between individual patient factors and substantial clinical benefit from telerehabilitation among a cohort of patients with chronic low back pain (LBP). METHODS: This is a secondary analysis of data collected during a prospective longitudinal cohort study. Patients with chronic LBP (N = 98) were provided with a standardized physical therapy protocol adapted for telerehabilitation. We examined the relationship between patient factors and substantial clinical benefit with telerehabilitation, defined as a ≥50% improvement in disability at 10 weeks, measured using the Oswestry Disability Index. RESULTS: Sixteen (16.3%) patients reported a substantial clinical benefit from telerehabilitation. Patients reporting substantial clinical benefit from telerehabilitation had lower initial pain intensity, lower psychosocial risk per the STarT Back Screening Tool, higher levels of pain self-efficacy, and reported higher therapeutic alliance with their physical therapist compared to other patients. CONCLUSION: Patients with lower psychosocial risk and higher pain-self efficacy experienced substantial clinical benefit from telerehabilitation for chronic LBP more often than other patients in our cohort. Therapeutic alliance was higher among patients who experienced a substantial clinical benefit compared to those who did not. IMPACT: This study indicates that psychosocial factors play an important role in the outcomes of patients receiving telerehabilitation for chronic LBP. Baseline psychosocial screening may serve as a method for identifying patients likely to benefit from this approach.

Use of implementation mapping in the planning of a hybrid type 1 pragmatic clinical trial: the BeatPain Utah study.

Background: Considerable disparities in chronic pain management have been identified. Persons in rural, lower income and minoritized communities are less likely to receive evidence-based, nonpharmacologic care. Telehealth delivery of nonpharmacologic, evidence-based interventions for persons with chronic pain is a promising strategy to lessen disparities, but implementation comes with many challenges. The BeatPain Utah study is a hybrid type I effectiveness-implementation pragmatic clinical trial investigating telehealth strategies to provide nonpharmacologic care from physical therapists to persons with chronic back pain receiving care in Community Health Centers (CHCs). CHCs provide primary care to all persons regardless of ability to pay. This paper outlines the use of implementation mapping to develop a multifaceted implementation plan for the BeatPain study. Methods: During a planning year for the BeatPain trial we developed a comprehensive logic model including the 5-step implementation mapping process informed by additional frameworks and theories. The five iterative implementation mapping steps were addressed in the planning year; 1) conduct needs assessments for involved groups; 2) identify implementation outcomes, performance objectives and determinants; 3) select implementation strategies; 4) produce implementation protocols and materials; and 5) evaluate implementation outcomes. Results: CHC leadership/providers, patients and physical therapists were identified as involved groups. Barriers and assets were identified across groups which informed identification of performance objectives necessary to implement two key processes; 1) electronic referral of patients with back pain in CHC clinics to the BeatPain team; and 2) connecting patients with physical therapists providing telehealth. Determinants of the performance objectives for each group informed our choice of implementation strategies which focused on training, education, clinician support and tailoring physical therapy interventions for telehealth delivery and cultural competency. We selected implementation outcomes for the BeatPain trial to evaluate the success of our implementation strategies. Conclusions: Implementation mapping provided a comprehensive and systematic approach to develop an implementation plan during the planning phase for our ongoing hybrid effectiveness-implementation trial. We will be able to evaluate the implementation strategies used in the BeatPain Utah study to inform future efforts to implement telehealth delivery of evidence-based pain care in CHCs and other settings. Trial registration: Clinicaltrials.gov Identifier: NCT04923334. Registered June 11, 2021 (https://clinicaltrials.gov/study/NCT04923334.

A new paradigm for musculoskeletal pain care: moving beyond structural impairments. Conclusion of a chiropractic and manual therapies thematic series.

This commentary closes the thematic series "A new paradigm for musculoskeletal pain care: moving beyond structural impairments". The papers published in the series point to key aspects of shifting the paradigm of musculoskeletal care from clinician-led management often focused on addressing presumed structural anomalies to partnering with patients to find individual strategies that empower patients towards self-management. Several papers in the series highlighted the need for developing patient-centred models of care that respect individual patient's needs and preferences. Also, the series pointed to different options for modes of delivery including mHealth and the challenges and opportunities they present for developing person-centred strategies. For health care to provide effective support for people with musculoskeletal pain conditions, there is a need to recognise that contextual factors, including a strong patient-provider alliance, clearly play an important, perhaps primary, role. Health care professions dealing with musculoskeletal pain conditions should engage in research to investigate effective ways to move this understanding into practice including how to train providers. We hope the work collected in this series will stimulate further questions and more research as musculoskeletal pain providers seek to make their care more person-centred.

Post-lumbar surgery prescription variation and opioid-related outcomes in a large US healthcare system: an observational study.

BACKGROUND CONTEXT: Spinal decompression and fusion procedures are one of the most common procedures performed in the United States (US) and remain associated with high postsurgical opioid burden. Despite guidelines emphasizing nonopioid pharmacotherapy strategies for postsurgical pain management, prescribing practices are likely variable and guideline-incongruent. PURPOSE: The purpose of this study was to characterize patient-, care-, and system-level factors associated with opioid, nonopioid pain medication, and benzodiazepine prescribing variation in the US Military Health System (MHS). STUDY DESIGN/SETTING: Retrospective study analyzing medical records from the US MHS Data Repository. PATIENT SAMPLE: Adult patients (N=6,625) undergoing lumbar decompression and spinal fusion procedures from 2016 to 2021 in the MHS enrolled in TRICARE at least a year prior to their procedure and had at least one encounter beyond the 90-day postprocedure period, without recent trauma, malignancy, cauda equina syndrome, and co-occurring procedures. OUTCOME MEASURES: Patient-, care-, and system-level factors influencing outcomes of discharge morphine equivalent dose (MED), 30-day opioid refill, and persistent opioid use (POU). POU was defined as dispensing of opioid prescriptions monthly for the first 3 months after surgery and then at least once between 90 and 180 days after surgery. METHODS: (Generalized) linear mixed models evaluated multilevel factors associated with discharge MED, opioid refill, and POU. RESULTS: The median discharge MED was 375 mg (IQR 225, 580) and days' supply was 7 days (IQR 4, 10); 36% received an opioid refill and 5%, overall, met criteria for POU. Discharge MED was associated with fusion procedures (+151-198 mg), multilevel procedures (+26 mg), policy release (-184 mg), opioid naïvty (-31 mg), race (Black -21 mg, another race and ethnicity -47 mg), benzodiazepine receipt (+100 mg), opioid-only medications (+86 mg), gabapentinoid receipt (-20 mg), and nonopioid pain medications receipt (-60 mg). Longer symptom duration, fusion procedures, beneficiary category, mental healthcare, nicotine dependence, benzodiazepine receipt, and opioid naivety were associated with both opioid refill and POU. Multilevel procedures, elevated comorbidity score, policy period, antidepressant receipt, and gabapentinoid receipt, and presurgical physical therapy were also associated with opioid refill. POU increased with increasing discharge MED. CONCLUSIONS: Significant variation in discharge prescribing practices require systems-level, evidence-based intervention.

Patients' Perceptions of Physical Therapists Addressing Opioid Misuse.

INTRODUCTION: In the US, rising numbers of patients who misuse illicit or prescribed opioids provides opportunities for physical therapists (PTs) to be engaged in their care. Prior to this engagement, it is necessary to understand the perceptions of patients who access physical therapy services about their PTs playing such a role. This project examined patients' perceptions of PTs addressing opioid misuse. METHODS: We surveyed patients, newly encountering outpatient physical therapy services in a large University-based healthcare setting, via anonymous, web-based survey. Within the survey, questions were rated on a Likert scale (1 = completely disagree to 7 = completely agree) and we evaluated responses of patients who were prescribed opioids versus those who were not. RESULTS: Among 839 respondents, the highest mean score was 6.2 (SD = 1.5) for "It is OK for physical therapists to refer their patients with prescription opioid misuse to a specialist to address the opioid misuse." The lowest mean score was 5.6 (SD = 1.9) for "It is OK for physical therapists to ask their patient why they are misusing prescription opioids." Compared to those with no prescription opioid exposure while attending physical therapy, patients with prescription opioid exposure had lower agreement that it was OK for the physical therapist to refer their patients with opioid misuse to a specialist (ß = -.33, 95% CI = -0.63 to -0.03). CONCLUSIONS: Patients attending outpatient physical therapy seem to support PTs addressing opioid misuse and there are differences in support based on whether the patients had exposure to opioids.

Characterizing modifications to a comparative effectiveness research study: the OPTIMIZE trial-using the Framework for Reporting Adaptations and Modifications to Evidence-based Interventions (FRAME).

BACKGROUND: The OPTIMIZE trial is a multi-site, comparative effectiveness research (CER) study that uses a Sequential Multiple Assessment Randomized Trial (SMART) designed to examine the effectiveness of complex health interventions (cognitive behavioral therapy, physical therapy, and mindfulness) for adults with chronic low back pain. Modifications are anticipated when implementing complex interventions in CER. Disruptions due to COVID have created unanticipated challenges also requiring modifications. Recent methodologic standards for CER studies emphasize that fully characterizing modifications made is necessary to interpret and implement trial results. The purpose of this paper is to outline the modifications made to the OPTIMIZE trial using the Framework for Reporting Adaptations and Modifications to Evidence-Based Interventions (FRAME) to characterize modifications to the OPTIMIZE trial in response to the COVID pandemic and other challenges encountered. METHODS: The FRAME outlines a strategy to identify and report modifications to evidence-based interventions or implementation strategies, whether planned or unplanned. We use the FRAME to characterize the process used to modify the aspects of the OPTIMIZE trial. Modifications were made to improve lower-than-anticipated rates of treatment initiation and COVID-related restrictions. Contextual modifications were made to permit telehealth delivery of treatments originally designed for in-person delivery. Training modifications were made with study personnel to provide more detailed information to potential participants, use motivational interviewing communication techniques to clarify potential participants' motivation and possible barriers to initiating treatment, and provide greater assistance with scheduling of assigned treatments. RESULTS: Modifications were developed with input from the trial's patient and stakeholder advisory panels. The goals of the modifications were to improve trial feasibility without compromising the interventions' core functions. Modifications were approved by the study funder and the trial steering committee. CONCLUSIONS: Full and transparent reporting of modifications to clinical trials, whether planned or unplanned, is critical for interpreting the trial's eventual results and considering future implementation efforts. TRIAL REGISTRATION: ClinicalTrials.gov NCT03859713. Registered on March 1, 2019.

Intervention delivery for embedded pragmatic clinical trials: Development of a tool to measure complexity.

BACKGROUND: Conducting an embedded pragmatic clinical trial in the workflow of a healthcare system is a complex endeavor. The complexity of the intervention delivery can have implications for study planning, ability to maintain fidelity to the intervention during the trial, and/or ability to detect meaningful differences in outcomes. METHODS: We conducted a literature review, developed a tool, and conducted two rounds of phone calls with NIH Pragmatic Trials Collaboratory Demonstration Project principal investigators to develop the Intervention Delivery Complexity Tool. After refining the tool, we piloted it with Collaboratory demonstration projects and developed an online version of the tool using the R Shiny application (https://duke-som.shinyapps.io/ICT-ePCT/). RESULTS: The 6-item tool consists of internal and external factors. Internal factors pertain to the intervention itself and include workflow, training, and the number of intervention components. External factors are related to intervention delivery at the system level including differences in healthcare systems, the dependency on setting for implementation, and the number of steps between the intervention and the outcome. CONCLUSION: The Intervention Delivery Complexity Tool was developed as a standard way to overcome communication challenges of intervention delivery within an embedded pragmatic trial. This version of the tool is most likely to be useful to the trial team and its health system partners during trial planning and conduct. We expect further evolution of the tool as more pragmatic trials are conducted and feedback is received on its performance outside of the NIH Pragmatic Trials Collaboratory.

Intervention Fidelity in Pain Pragmatic Trials for Nonpharmacologic Pain Management: Nuanced Considerations for Determining PRECIS-2 Flexibility in Delivery and Adherence.

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 9 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.