Association between chiropractic spinal manipulation and cauda equina syndrome in adults with low back pain: Retrospective cohort study of US academic health centers.

BACKGROUND: Cauda equina syndrome (CES) is a lumbosacral surgical emergency that has been associated with chiropractic spinal manipulation (CSM) in case reports. However, identifying if there is a potential causal effect is complicated by the heightened incidence of CES among those with low back pain (LBP). The study hypothesis was that there would be no increase in the risk of CES in adults with LBP following CSM compared to a propensity-matched cohort following physical therapy (PT) evaluation without spinal manipulation over a three-month follow-up period. METHODS: A query of a United States network (TriNetX, Inc.) was conducted, searching health records of more than 107 million patients attending academic health centers, yielding data ranging from 20 years prior to the search date (July 30, 2023). Patients aged 18 or older with LBP were included, excluding those with pre-existing CES, incontinence, or serious pathology that may cause CES. Patients were divided into two cohorts: (1) LBP patients receiving CSM or (2) LBP patients receiving PT evaluation without spinal manipulation. Propensity score matching controlled for confounding variables associated with CES. RESULTS: 67,220 patients per cohort (mean age 51 years) remained after propensity matching. CES incidence was 0.07% (95% confidence intervals [CI]: 0.05-0.09%) in the CSM cohort compared to 0.11% (95% CI: 0.09-0.14%) in the PT evaluation cohort, yielding a risk ratio and 95% CI of 0.60 (0.42-0.86; p = .0052). Both cohorts showed a higher rate of CES during the first two weeks of follow-up. CONCLUSIONS: These findings suggest that CSM is not a risk factor for CES. Considering prior epidemiologic evidence, patients with LBP may have an elevated risk of CES independent of treatment. These findings warrant further corroboration. In the meantime, clinicians should be vigilant to identify LBP patients with CES and promptly refer them for surgical evaluation.

Healthcare provider perspectives on integrating a comprehensive spine care model in an academic health system: a cross-sectional survey.

BACKGROUND: Healthcare systems (HCS) are challenged in adopting and sustaining comprehensive approaches to spine care that require coordination and collaboration among multiple service units. The integration of clinicians who provide first line, evidence-based, non-pharmacological therapies further complicates adoption of these care pathways. This cross-sectional study explored clinician perceptions about the integration of guideline-concordant care and optimal spine care workforce requirements within an academic HCS. METHODS: Spine care clinicians from Duke University Health System (DUHS) completed a 26-item online survey via Qualtrics on barriers and facilitators to delivering guideline concordant care for low back pain patients. Data analysis included descriptive statistics and qualitative content analysis. RESULTS: A total of 27 clinicians (57% response) responded to one or more items on the questionnaire, with 23 completing the majority of questions. Respondents reported that guidelines were implementable within DUHS, but no spine care guideline was used consistently across provider types. Guideline access and integration with electronic records were barriers to use. Respondents (81%) agreed most patients would benefit from non-pharmacological therapies such as physical therapy or chiropractic before receiving specialty referrals. Providers perceived spine patients expected diagnostic imaging (81%) and medication (70%) over non-pharmacological therapies. Providers agreed that receiving imaging (63%) and opioids (59%) benchmarks could be helpful but might not change their ordering practice, even if nudged by best practice advisories. Participants felt that an optimal spine care workforce would require more chiropractors and primary care providers and fewer neurosurgeons and orthopedists. In qualitative responses, respondents emphasized the following barriers to guideline-concordant care implementation: patient expectations, provider confidence with referral pathways, timely access, and the appropriate role of spine surgery. CONCLUSIONS: Spine care clinicians had positive support for current tenets of guideline-concordant spine care for low back pain patients. However, significant barriers to implementation were identified, including mixed opinions about integration of non-pharmacological therapies, referral pathways, and best practices for imaging and opioid use.

Development of a low back pain care pathway in an academic hospital system: results of a consensus process.

BACKGROUND: Low back pain (LBP) is the leading cause of disability worldwide and a significant component of healthcare expenditures. Clinical practice guidelines (CPGs) have been highlighted as a key resource to improve the quality of care. This study aimed to develop a clinical pathway for LBP based on CPGs in an academic health system. METHODS: We conducted a modified Delphi study of clinicians caring for patients with LBP who were asked to rate 21 CPG-informed seed statements through an online survey. The goal was to identify statements that achieved a minimum of 80% consensus among panelists. RESULTS: Thirty-five healthcare providers participated as panelists. The majority of participants were male (68.6%), had MD or DO (62.9%) degrees, and were clinicians (73.8%) working in neurosurgery (36.1%), orthopedics (25.7%), emergency medicine (14.3%), or physical therapy (11.4%). Initially, consensus was reached on 20 of 21 seed statements. One statement did not reach consensus in the initial round and was revised into two separate statements based on feedback from panelists. One of these statements achieved consensus in the second review round. All statements reaching consensus were incorporated into a care pathway consisting of diagnosis, evaluation, and treatment for LBP. CONCLUSION: Healthcare providers across various disciplines supported statements interpreting current CPGs related to care for LBP. This study represents a step toward supporting guideline-concordant care for LBP. Additional research is needed to assess how such pathways impact actual clinical care.

Patient engagement in designing, conducting, and disseminating clinical pain research: IMMPACT recommended considerations.

ABSTRACT: In the traditional clinical research model, patients are typically involved only as participants. However, there has been a shift in recent years highlighting the value and contributions that patients bring as members of the research team, across the clinical research lifecycle. It is becoming increasingly evident that to develop research that is both meaningful to people who have the targeted condition and is feasible, there are important benefits of involving patients in the planning, conduct, and dissemination of research from its earliest stages. In fact, research funders and regulatory agencies are now explicitly encouraging, and sometimes requiring, that patients are engaged as partners in research. Although this approach has become commonplace in some fields of clinical research, it remains the exception in clinical pain research. As such, the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials convened a meeting with patient partners and international representatives from academia, patient advocacy groups, government regulatory agencies, research funding organizations, academic journals, and the biopharmaceutical industry to develop consensus recommendations for advancing patient engagement in all stages of clinical pain research in an effective and purposeful manner. This article summarizes the results of this meeting and offers considerations for meaningful and authentic engagement of patient partners in clinical pain research, including recommendations for representation, timing, continuous engagement, measurement, reporting, and research dissemination.

Chiropractic Day 2023: A Report and Qualitative Analysis of How Thought Leaders Celebrate the Present and Envision the Future of Chiropractic.

Objective: This study aimed to (1) collect and analyze statements about how to celebrate chiropractic in the present and roles that chiropractors may fulfill in the future, (2) identify if there was congruence among the themes between present and future statements, and (3) offer a model about the chiropractic profession that captures its complex relationships that encompass its interactions within microsystem, mesosystem, exosystem, and macrosystem levels. Methods: For this qualitative analysis, we used pattern and grounded theory approaches. A purposive sample of thought leaders in the chiropractic profession were invited to answer the following 2 open-ended questions: (1) envision the chiropractor of the future, and (2) recommendations on how to celebrate chiropractic. Information was collected during April 2023 using Survey Monkey. The information was entered into a spreadsheet and analyzed for topic clusters, which resulted in matching concepts with social-ecological themes. The themes between the responses to the 2 questions were analyzed for congruence. We used the Standards for Reporting Qualitative Research to report our findings. Results: Of the 54 experts invited, 32 (59%) participated. Authors represented 7 countries and have a median of 32 years of chiropractic experience, with a range of 5 to 51 years. Nineteen major topics in the future statements and 23 major topics in statements about celebrating chiropractic were combined in a model. The topics were presented using the 4 levels of the social-ecological framework. Individual (microsystem): chiropractors are competent, well-educated experts in spine and musculoskeletal care who apply evidence-based practices, which is a combination of the best available evidence, clinical expertise, and patient values. Interpersonal relationships (mesosystem): chiropractors serve the best interests of their patients, provide person-centered care, embrace diversity, equity, and inclusion, consider specific health needs and the health of the whole person. Community (exosystem): chiropractors provide care within integrated health care environments and in private practices, serve the best interests of the public through participation in their communities, participate through multidisciplinary collaboration with and within the health care system, and work together as a profession with a strong professional identity. Societal (macrosystem): chiropractors contribute to the greater good of society and participate on a global level in policy, leadership, and research. There was concordance between both the future envisioning statements and the present celebration recommendations, which suggest logical validity based on the congruence of these concepts. Conclusion: A sample of independent views, including the perceptions from a broad range of chiropractic thought leaders from various backgrounds, philosophies, diversity characteristics, and world regions, were assembled to create a comprehensive model of the chiropractic profession. The resulting model shows an array of intrinsic values and provides the roles that chiropractors may provide to serve patients and the public. This study offers insights into the roles that future chiropractors may fulfill and how these are congruent with present-day values. These core concepts and this novel model may have utility during dialogs about identity, applications regarding chiropractic in policy, practice, education, and research, and building positive relationships and collaborations.

Overcoming Barriers to the Implementation of Integrated Musculoskeletal Pain Management Programs: A Multi-Stakeholder Qualitative Study.

Integrated pain management (IPM) programs can help to reduce the substantial population health burden of musculoskeletal pain, but are poorly implemented. Lessons learned from existing programs can inform efforts to expand IPM implementation. This qualitative study describes how health care systems, payers, providers, health policy researchers, and other stakeholders are overcoming barriers to developing and sustaining IPM programs in real-world settings. Primary data were collected February 2020 through September 2021 from a multi-sector expert panel of 25 stakeholders, 53 expert interviews representing 30 distinct IPM programs across the United States, and 4 original case studies of exemplar IPM programs. We use a consensual team-based approach to systematically analyze qualitative findings. We identified 4 major themes around challenges and potential solutions for implementing IPM programs: navigating coverage, payment, and reimbursement; enacting organizational change; making a business case to stakeholders; and overcoming regulatory hurdles. Strategies to address payment challenges included use of group visits, linked visits between billable and nonbillable providers, and development of value-based payment models. Organizational change strategies included engagement of clinical and administrative champions and co-location of services. Business case strategies involved demonstrating the ability to initially break even and potential to reduce downstream costs, while improving nonfinancial outcomes like patient satisfaction and provider burnout. Regulatory hurdles were overcome with innovative credentialing methods by leveraging available waivers and managed care contracting to expand access to IPM services. Lessons from existing programs provide direction on to grow and support such IPM delivery models across a variety of settings. PERSPECTIVE: Integrated pain management (IPM) programs face numerous implementation challenges related to payment, organizational change, care coordination, and regulatory requirements. Drawing on real-world experiences of existing programs and from diverse IPM stakeholders, we outline actionable strategies that health care systems, providers, and payers can use to expand implementation of these programs.

TIDieR-telehealth: precision in reporting of telehealth interventions used in clinical trials - unique considerations for the Template for the Intervention Description and Replication (TIDieR) checklist.

BACKGROUND: Recent international health events have led to an increased proliferation of remotely delivered health interventions. Even with the pandemic seemingly coming under control, the experiences of the past year have fueled a growth in ideas and technology for increasing the scope of remote care delivery. Unfortunately, clinicians and health systems will have difficulty with the adoption and implementation of these interventions if ongoing and future clinical trials fail to report necessary details about execution, platforms, and infrastructure related to these interventions. The purpose was to develop guidance for reporting of telehealth interventions. METHODS: A working group from the US Pain Management Collaboratory developed guidance for complete reporting of telehealth interventions. The process went through 5-step process from conception to final checklist development with input for many stakeholders, to include all 11 primary investigators with trials in the Collaboratory. RESULTS: An extension focused on unique considerations relevant to telehealth interventions was developed for the Template for the Intervention Description and Replication (TIDieR) checklist. CONCLUSION: The Telehealth Intervention guideline encourages use of the Template for the Intervention Description and Replication (TIDieR) checklist as a valuable tool (TIDieR-Telehealth) to improve the quality of research through a reporting guide of relevant interventions that will help maximize reproducibility and implementation.

Care Outcomes for Chiropractic Outpatient Veterans (COCOV): a single-arm, pragmatic, pilot trial of multimodal chiropractic care for U.S. veterans with chronic low back pain.

BACKGROUND: Over 25% of veterans seeking care at U.S. Veterans Health Administration facilities have chronic low back pain (LBP), with high rates of mental health comorbidities. The primary objective of this study was to assess the feasibility of participant recruitment, retention, and electronic data collection to prepare for the subsequent randomized trial of multimodal chiropractic care for pain management of veterans with chronic low back pain. The secondary objectives were to estimate effect sizes and variability of the primary outcome and choose secondary outcomes for the full-scale trial. METHODS: This single-arm pilot trial enrolled 40 veterans with chronic LBP at one Veterans Health Administration facility for a 10-week course of pragmatic multimodal chiropractic care. Recruitment was by (1) provider referral, (2) invitational letter from the electronic health record pre-screening, and (3) standard direct recruitment. We administered patient-reported outcome assessments through an email link to REDCap, an electronic data capture platform, at baseline and 5 additional timepoints. Retention was tracked through adherence to the treatment plan and completion rates of outcome assessments. Descriptive statistics were calculated for baseline characteristics and outcome variables. RESULTS: We screened 91 veterans over 6 months to enroll our goal of 40 participants. Seventy percent were recruited through provider referrals. Mean age (range) was 53 (22-79) years and 23% were female; 95% had mental health comorbidities. The mean number of chiropractic visits was 4.5 (1-7). Participants adhered to their treatment plan, with exception of 3 who attended only their first visit. All participants completed assessments at the in-person baseline visit and 80% at the week 10 final endpoint. We had no issues administering assessments via REDCap. We observed clinically important improvements on the Roland-Morris Disability Questionnaire [mean change (SD): 3.6 (6.1)] and on PROMIS® pain interference [mean change (SD): 3.6 (5.6)], which will be our primary and key secondary outcome, respectively, for the full-scale trial. CONCLUSIONS: We demonstrated the feasibility of participant recruitment, retention, and electronic data collection for conducting a pragmatic clinical trial of chiropractic care in a Veterans Health Administration facility. Using the pilot data and lessons learned, we modified and refined a protocol for a full-scale, multisite, pragmatic, National Institutes of Health-funded randomized trial of multimodal chiropractic care for veterans with chronic LBP that began recruitment in February 2021. TRIAL REGISTRATION: ClinicalTrials.gov NCT03254719.

Care Outcomes for Chiropractic Outpatient Veterans (COCOV): a qualitative study with veteran stakeholders from a pilot trial of multimodal chiropractic care.

BACKGROUND: Low back pain (LBP) is common among military veterans seeking treatment in Department of Veterans Affairs (VA) healthcare facilities. As chiropractic services within VA expand, well-designed pragmatic trials and implementation studies are needed to assess clinical effectiveness and program uptake. This study evaluated veteran stakeholder perceptions of the feasibility and acceptability of care delivery and research processes in a pilot trial of multimodal chiropractic care for chronic LBP. METHODS: The qualitative study was completed within a mixed-method, single-arm, pragmatic, pilot clinical trial of chiropractic care for LBP conducted in VA chiropractic clinics. Study coordinators completed semi-structured, in person or telephone interviews with veterans near the end of the 10-week trial. Interviews were audiorecorded and transcribed verbatim. Qualitative content analysis using a directed approach explored salient themes related to trial implementation and delivery of chiropractic services. RESULTS: Of 40 participants, 24 completed interviews (60% response; 67% male gender; mean age 51.7 years). Overall, participants considered the trial protocol and procedures feasible and reported that the chiropractic care and recruitment methods were acceptable. Findings were organized into 4 domains, 10 themes, and 21 subthemes. Chiropractic service delivery domain encompassed 3 themes/8 subthemes: scheduling process (limited clinic hours, scheduling future appointments, attendance barriers); treatment frequency (treatment sufficient for LBP complaint, more/less frequent treatments); and chiropractic clinic considerations (hire more chiropractors, including female chiropractors; chiropractic clinic environment; patient-centered treatment visits). Outcome measures domain comprised 3 themes/4 subthemes: questionnaire burden (low burden vs. time-consuming or repetitive); relevance (items relevant for LBP study); and timing and individualization of measures (questionnaire timing relative to symptoms, personalized approach to outcomes measures). The online data collection domain included 2 themes/4 subthemes: user concerns (little difficulty vs. form challenges, required computer skills); and technology issues (computer/internet access, junk mail). Clinical trial planning domain included 2 themes/5 subthemes: participant recruitment (altruistic service by veterans, awareness of chiropractic availability, financial compensation); and communication methods (preferences, potential barriers). CONCLUSIONS: This qualitative study highlighted veteran stakeholders' perceptions of VA-based chiropractic services and offered important suggestions for conducting a full-scale, veteran-focused, randomized trial of multimodal chiropractic care for chronic LBP in this clinical setting. TRIAL REGISTRATION: ClinicalTrials.gov NCT03254719.

Health-Related Quality of Life Among United States Service Members with Low Back Pain Receiving Usual Care Plus Chiropractic Care vs Usual Care Alone: Secondary Outcomes of a Pragmatic Clinical Trial.

OBJECTIVE: This study examines Patient-Reported Outcome Measurement Information System (PROMIS®)-29 v1.0 outcomes of chiropractic care in a multi-site, pragmatic clinical trial and compares the PROMIS measures to: 1) worst pain intensity from a numerical pain rating 0-10 scale, 2) 24-item Roland-Morris Disability Questionnaire (RMDQ); and 3) global improvement (modified visual analog scale). DESIGN: A pragmatic, prospective, multisite, parallel-group comparative effectiveness clinical trial comparing usual medical care (UMC) with UMC plus chiropractic care (UMC+CC). SETTING: Three military treatment facilities. SUBJECTS: 750 active-duty military personnel with low back pain. METHODS: Linear mixed effects regression models estimated the treatment group differences. Coefficient of repeatability to estimate significant individual change. RESULTS: We found statistically significant mean group differences favoring UMC+CC for all PROMIS®-29 scales and the RMDQ score. Area under the curve estimates for global improvement for the PROMIS®-29 scales and the RMDQ, ranged from 0.79 to 0.83. CONCLUSIONS: Findings from this pre-planned secondary analysis demonstrate that chiropractic care impacts health-related quality of life beyond pain and pain-related disability. Further, comparable findings were found between the 24-item RMDQ and the PROMIS®-29 v1.0 briefer scales.

Characteristics of Chiropractic Patients in the Veterans Health Administration During the COVID-19 Pandemic: A Cross-Sectional Analysis.

OBJECTIVE: The purpose of this study was to determine whether patient characteristics were associated with face-to-face (F2F) and telehealth visits for those receiving chiropractic care for musculoskeletal conditions in the US Veterans Health Administration (VHA) during the COVID-19 pandemic. METHODS: A retrospective cross-sectional analysis of all patients (veterans, dependents, and spouses) who received chiropractic care nationwide at the VHA from March 1, 2020, to February 28, 2021, was performed. Patients were allocated into 1 of the following 3 groups: only telehealth visits, only F2F visits, and combined F2F and telehealth visits. Patient characteristics included age, sex, race, ethnicity, marital status, and Charlson Comorbidity Index. Multinomial logistic regression estimated associations of these variables with visit type. RESULTS: The total number of unique patients seen by chiropractors between March 2020 and February 2021 was 62 658. Key findings were that patients of non-White race and Hispanic or Latino ethnicity were more likely to attend telehealth-only visits (Black [odds ratio 1.20, 95% confidence interval {1.10-1.31}], other races [1.36 {1.16-1.59}], and Hispanic or Latino [1.35 {1.20-1.52}]) and combination telehealth and F2F care (Black [1.32 {1.25-1.40}], other races [1.37 {1.23-1.52}], and Hispanic or Latino [1.63 {1.51-1.76}]). Patients younger than 40 years of age were more likely to choose telehealth visits ([1.13 {1.02-1.26}], 66-75 years [1.17 {1.01-1.35}], and >75 years [1.26 {1.06-1.51}] vs those 40-55 years of age). Sex, visit frequency, and Charlson Comorbidity Index showed significant relationships as well, while marital status did not. CONCLUSION: During the COVID-19 pandemic, VHA patients with musculoskeletal complaints using chiropractic telehealth were more ethnically and racially diverse than those using F2F care alone.

Optimizing the Impact of Pragmatic Clinical Trials for Veteran and Military Populations: Lessons From the Pain Management Collaboratory.

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

Back and neck pain: in support of routine delivery of non-pharmacologic treatments as a way to improve individual and population health.

Chronic back and neck pain are highly prevalent conditions that are among the largest drivers of physical disability and cost in the world. Recent clinical practice guidelines recommend use of non-pharmacologic treatments to decrease pain and improve physical function for individuals with back and neck pain. However, delivery of these treatments remains a challenge because common care delivery models for back and neck pain incentivize treatments that are not in the best interests of patients, the overall health system, or society. This narrative review focuses on the need to increase use of non-pharmacologic treatment as part of routine care for back and neck pain. First, we present the evidence base and summarize recommendations from clinical practice guidelines regarding non-pharmacologic treatments. Second, we characterize current use patterns for non-pharmacologic treatments and identify potential barriers to their delivery. Addressing these barriers will require coordinated efforts from multiple stakeholders to prioritize evidence-based non-pharmacologic treatment approaches over low value care for back and neck pain. These stakeholders include patients, health care providers, health care organizations, administrators, payers, policymakers and researchers.

Extrapolating Beyond the Data in a Systematic Review of Spinal Manipulation for Nonmusculoskeletal Disorders: A Fall From the Summit.

OBJECTIVE: The purpose of this article is to discuss a literature review-a recent systematic review of nonmusculoskeletal disorders-that demonstrates the potential for faulty conclusions and misguided policy implications, and to offer an alternate interpretation of the data using present models and criteria. METHODS: We participated in a chiropractic meeting (Global Summit) that aimed to perform a systematic review of the literature on the efficacy and effectiveness of mobilization or spinal manipulative therapy (SMT) for the primary, secondary, and tertiary prevention and treatment of nonmusculoskeletal disorders. After considering an early draft of the resulting manuscript, we identified points of concern and therefore declined authorship. The present article was developed to describe those concerns about the review and its conclusions. RESULTS: Three main concerns were identified: the inherent limitations of a systematic review of 6 articles on the topic of SMT for nonmusculoskeletal disorders, the lack of biological plausibility of collapsing 5 different disorders into a single category, and considerations for best practices when using evidence in policy-making. We propose that the following conclusion is more consistent with a review of the 6 articles. The small cadre of high- or moderate-quality randomized controlled trials reviewed in this study found either no or equivocal effects from SMT as a stand-alone treatment for infantile colic, childhood asthma, hypertension, primary dysmenorrhea, or migraine, and found no or low-quality evidence available to support other nonmusculoskeletal conditions. Therefore, further research is needed to determine if SMT may have an effect in these and other nonmusculoskeletal conditions. Until the results of such research are available, the benefits of SMT for specific or general nonmusculoskeletal disorders should not be promoted as having strong supportive evidence. Further, a lack of evidence cannot be interpreted as counterevidence, nor used as evidence of falsification or verification. CONCLUSION: Based on the available evidence, some statements generated from the Summit were extrapolated beyond the data, have the potential to misrepresent the literature, and should be used with caution. Given that none of the trials included in the literature review were definitively negative, the current evidence suggests that more research on nonmusculoskeletal conditions is warranted before any definitive conclusions can be made. Governments, insurers, payers, regulators, educators, and clinicians should avoid using systematic reviews in decisions where the research is insufficient to determine the clinical appropriateness of specific care.

Patient-Reported Physician Treatment Recommendations and Compliance Among U.S. Adults with Low Back Pain.

Objectives: Numerous recently published clinical care guidelines, including the 2017 American College of Physicians (ACP) Guideline for Low Back Pain (LBP), call for nonpharmacological approaches to pain management. However, little data exist regarding the extent to which these guidelines have been adopted by patients and medical doctors. The study objective was to determine patient-reported treatment recommendations by medical doctors for LBP and patient compliance with those recommendations. Design: This study used a cross-sectional web and mail survey. Settings/Location: The study was conducted among Gallup Panel members across the United States. Subjects: Survey participants included 5377 U.S. adults randomly selected among Gallup Panel members. Of those, 545 reported a visit to a medical doctor within the past year for low back pain and were asked a series of follow-up questions regarding treatment recommendations. Interventions: Participants were asked about medical doctor recommendations for both drug (acetaminophen, nonsteroidal anti-inflammatory drugs [NSAIDs], opioids, benzodiazepines, Gabapentin, Neurontin, and cortisone injections) and nondrug (self-care treatments, massage, acupuncture, spinal manipulation, and physical therapy) treatments. Outcome Measures: Participants were asked to indicate if their medical doctor recommended each drug and nondrug therapy for their LBP and if they had followed each of those treatment recommendations. Results: Ninety-six percent of patients who visited a medical doctor for LBP received a recommendation for one or more pain treatments, with 81% reporting that their medical doctor recommended both drug and nondrug therapies. Seventy-six percent of respondents were recommended acetaminophen or NSAIDs, 79% were recommended self-care treatments, 37% were recommended massage, acupuncture, or spinal manipulation, and 60% were recommended physical therapy. Nearly two-thirds of our sample reported that their doctor had recommended prescription medications, including opioids, benzodiazepines, Gabapentin, Neurontin, or cortisone injections. Reported adherence to treatment recommendations ranged from 68% for acupuncture to 94% for NSAIDs. Conclusions: One year after publication of the ACP's Guideline on LBP, patients report that medical doctors recommended both pharmacological and nonpharmacological treatment approaches to patients with LBP. In the majority of cases, a combination of prescription medications and self-care were recommended, illustrating the need for additional research on the effectiveness of multi-modal treatment strategies. Patients reported that they were largely compliant with medical doctor recommendations, underscoring the influence that medical doctors have in directing patient care for LBP. These findings indicate that further work is also needed to explore the impact of personal experience, training, clinical evidence, sociocultural factors, and health plans on medical doctors therapeutic recommendations in the context of back pain.

Harmonized outcome measures for use in degenerative lumbar spondylolisthesis patient registries and clinical practice.

OBJECTIVE: The development of new treatment approaches for degenerative lumbar spondylolisthesis (DLS) has introduced many questions about comparative effectiveness and long-term outcomes. Patient registries collect robust, longitudinal data that could be combined or aggregated to form a national and potentially international research data infrastructure to address these and other research questions. However, linking data across registries is challenging because registries typically define and capture different outcome measures. Variation in outcome measures occurs in clinical practice and other types of research studies as well, limiting the utility of existing data sources for addressing new research questions. The purpose of this project was to develop a minimum set of patient- and clinician-relevant standardized outcome measures that are feasible for collection in DLS registries and clinical practice. METHODS: Nineteen DLS registries, observational studies, and quality improvement efforts were invited to participate and submit outcome measures. A stakeholder panel was organized that included representatives from medical specialty societies, health systems, government agencies, payers, industries, health information technology organizations, and patient advocacy groups. The panel categorized the measures using the Agency for Healthcare Research and Quality's Outcome Measures Framework (OMF), identified a minimum set of outcome measures, and developed standardized definitions through a consensus-based process. RESULTS: The panel identified and harmonized 57 outcome measures into a minimum set of 10 core outcome measure areas and 6 supplemental outcome measure areas. The measures are organized into the OMF categories of survival, clinical response, events of interest, patient-reported outcomes, and resource utilization. CONCLUSIONS: This effort identified a minimum set of standardized measures that are relevant to patients and clinicians and appropriate for use in DLS registries, other research efforts, and clinical practice. Collection of these measures across registries and clinical practice is an important step for building research data infrastructure, creating learning healthcare systems, and improving patient management and outcomes in DLS.

Visit Frequency and Outcomes for Patients Using Ongoing Chiropractic Care for Chronic Low-Back and Neck Pain: An Observational Longitudinal Study.

BACKGROUND: Chronic spinal pain is prevalent and long-lasting. Although provider-based nonpharmacologic therapies, such as chiropractic care, have been recommended, healthcare and coverage policies provide little guidance or evidence regarding long-term use of this care. OBJECTIVE: To determine the relationships between visit frequency and outcomes for patients using ongoing chiropractic care for chronic spinal pain. STUDY DESIGN: Observational 3-month longitudinal study. SETTING: Data collected from patients of 124 chiropractic clinics in 6 United States regions. METHODS: We examined the impact of visit frequency and patient characteristics on pain (pain 0-10 numeric rating scale) and functional outcomes (Oswestry Disability Index [ODI] for low-back pain and Neck Disability Index [NDI] for neck pain, both 0-100 scale) using hierarchical linear modeling (HLM) in a large national sample of chiropractic patients with chronic low back pain (CLBP) and/or chronic neck pain (CNP). This study was approved by the RAND Human Subjects Protection Committee and registered under ClinicalTrials.gov Identifier: NCT03162952. RESULTS: One thousand, three hundred, sixty-two patients with CLBP and 1,214 with CNP were included in a series of HLM models. Unconditional (time-only) models showed patients on average had mild pain and function, and significant, but slight improvements in these over the 3-month observation period: back and neck pain decreased by 0.40 and 0.44 points, respectively; function improved by 2.7 (ODI) and 3.0 points (NDI) (all P < 0.001). Adding chiropractic visit frequency to the models revealed that those with worse baseline pain and function used more visits, but only visits more than once per week for those with CLBP were associated with significantly better improvement. These relationships remained when other types of visits and baseline patient characteristics were included. LIMITATIONS: This is an observational study based on self-reported data from a sample representative of chiropractic patients, but not all patients with CLBP or CNP. CONCLUSIONS: This 3-month window on chiropractic patients with CLBP and/or CNP revealed that they were improving, although slowly; may have reached maximum therapeutic improvement; and are possibly successfully managing their chronic pain using a variety of chiropractic visit frequencies. These results may inform payers when building coverage policies for ongoing chiropractic care for patients with chronic pain.