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.

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.

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.

Differentiating rheumatoid and psoriatic arthritis: a systematic analysis of high-resolution magnetic resonance imaging features-preliminary findings.

BACKGROUND: Because of overlapping phenotypical presentations, the diagnostic differentiation of rheumatoid arthritis (RA) and psoriatic arthritis (PsA) remains challenging. Thus, this study aimed to examine the diagnostic value of distinct imaging features obtained by high-resolution 3-T MRI for the diagnostic differentiation. MATERIALS AND METHODS: Seventeen patients with PsA and 28 patients with RA were imaged at high resolution using 3-T MRI scanners and a dedicated 16-channel hand coil. All images were analyzed according to the outcome measures in rheumatology clinical trials' (OMERACT) RAMRIS (Rheumatoid Arthritis Magnetic Resonance Imaging Score) and PsAMRIS (Psoriatic Arthritis Magnetic Resonance Imaging Score) for the presence and intensity of synovitis, flexor tenosynovitis, bone edema, bone erosion, periarticular inflammation, bone proliferation, and joint space narrowing. Next, odds ratios (OR) were calculated to determine the strength of the associations between these imaging features, demographic characteristics, and the outcome RA vs. PsA. RESULTS: PsA could be differentiated from RA by extracapsular inflammatory changes (PsAMRIS sub-score "periarticular inflammation"), with low odds for the presence of RA (OR of 0.06, p < 0.01) at all metacarpophalangeal (MCP) joints. A prediction model informed by the items that were strongest associated with the presence of RA or PsA demonstrated excellent differentiating capability with an area under the curve of 98.1%. CONCLUSION: High-resolution imaging is beneficial for the identification of relevant imaging features that may assist the clinical differentiation of inflammatory conditions of the hand. At the MCP level, extracapsular inflammatory changes were strongly associated with PsA and may consequently allow the imaging differentiation of PsA and RA.

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.

Characteristics and Practice Patterns of U.S. Veterans Health Administration Doctors of Chiropractic: A Cross-sectional Survey.

OBJECTIVE: The purpose of this study was to survey U.S. Veterans Health Administration (VA) chiropractors to assess current demographic and professional characteristics, including practice parameters, interprofessional collaboration, academic experience, and scholarly activity. METHODS: A cross-sectional survey was performed from August 21, 2019, to September 6, 2019, including all chiropractors identified with any VA appointment. REDCap software was used to conduct the survey. Data from surveys were exported to Microsoft Excel for data analysis. RESULTS: Of the 177 providers solicited, 118 returned completed surveys (67% response rate). Respondents predominantly self-reported as white (84%) and male (77.1%), with a mean age of 47 years, and reported spending at least 75% of time on clinical care. Most respondents reported being VA employees (96%) with full-time appointments (94%). Approximately half reported having prior hospital training (48%), supervising chiropractic students (53%) and students in other health professions (47%), and authoring or coauthoring ≥1 peer-reviewed publications (42%). Respondents reported performing an average of 6 to 15 new-patient consultations and 31 to 60 follow-up visits per week. Most patient referrals to chiropractic care originated from primary care providers, with low back conditions without radiculopathy as the most frequently seen condition. Diversified manipulation and flexion-distraction techniques, along with myofascial therapies, therapeutic exercises, and self-management advice, were the most commonly reported interventions. CONCLUSION: We report provider and practice characteristics from chiropractors working in a large, integrated health care system. Most are full-time employees, work in physical medicine departments, and have held their position for up to 5 years. The majority of respondents report diagnostic and treatment approaches concordant with current clinical practice guidelines.

Chiropractic Services and Diagnoses for Low Back Pain in 3 U.S. Department of Defense Military Treatment Facilities: A Secondary Analysis of a Pragmatic Clinical Trial.

OBJECTIVE: The purpose of this study was to describe the diagnoses and chiropractic services performed by doctors of chiropractic operating within 3 military treatment facilities for patients with low back pain (LBP). METHODS: This was a descriptive secondary analysis of a pragmatic clinical trial comparing usual medical care (UMC) plus chiropractic care to UMC alone for U.S. active-duty military personnel with LBP. Participants who were allocated to receive UMC plus 6 weeks of chiropractic care and who attended at least 1 chiropractic visit (n = 350; 1547 unique visits) were included in this analysis. International Classification of Diseases and Current Procedural Terminology codes were transcribed from chiropractic treatment paper forms. The number of participants receiving each diagnosis and service and the number of each service on unique visits was tabulated. Low back pain and co-occurring diagnoses were grouped into neuropathic, nociceptive, bone and/or joint, general pain, and nonallopathic lesions categories. Services were categorized as evaluation, active interventions, and passive interventions. RESULTS: The most reported pain diagnoses were lumbalgia (66.1%) and thoracic pain (6.6%). Most reported neuropathic pain diagnoses were sciatica (4.9%) and lumbosacral neuritis or radiculitis (2.9%). For the nociceptive pain, low back sprain and/or strain (15.8%) and lumbar facet syndrome (9.2%) were most common. Most reported diagnoses in the bone and/or joint category were intervertebral disc degeneration (8.6%) and spondylosis (6.0%). Tobacco use disorder (5.7%) was the most common in the other category. Chiropractic care was compromised of passive interventions (94%), with spinal manipulative therapy being the most common, active interventions (77%), with therapeutic exercise being most common, and a combination of passive and active interventions (72%). CONCLUSION: For the sample in this study, doctors of chiropractic within 3 military treatment facilities diagnosed, managed, and provided clinical evaluations for a range of LBP conditions. Although spinal manipulation was the most commonly used modality, chiropractic care included a multimodal approach, comprising of both active and passive interventions a majority of the time.

Changes in the Use of Telehealth and Face-To-Face Chiropractic Care in the Department of Veterans Affairs Before and After the COVID-19 Pandemic.

OBJECTIVE: The purpose of this study was to describe the use of face-to-face and telehealth chiropractic care in the U.S. Veterans Health Administration (VHA) before and after the declaration of the COVID-19 pandemic. METHODS: A cross-sectional study was performed of VHA administrative data, including monthly numbers of unique patients and visits for face-to-face and telehealth (synchronous video or telephone) chiropractic care from October 1, 2019, to March 31, 2021. RESULTS: During the pre-pandemic phase (October 2019 to February 2020), a mean of 28 930 (SD 289) total monthly visits were conducted face-to-face (99.9%). In March 2020, total monthly visits decreased to 17.0% of the pre-pandemic average, 25.0% being face-to-face, with over a 200-fold increase in telehealth visits (rising to 1331 visits) compared to the pre-pandemic average. April showed the lowest number of face-to-face visits at (4094). May-October 2020 showed that face-to-face visits increase on average by 70.7% per month, while telehealth visits averaged 17.3% per month. October-February 2020 had total monthly visits plateau at a mean of 22 250 (76.9% of the pre-pandemic average). Telehealth visits reduced to a mean of 1245 monthly visits over this 5-month period, a drop of -5.6% of the average of monthly visits. In March 2021, total monthly visits (31 221) exceeded the pre-pandemic average for the first time since January 2020; 4.0% remained in telehealth. CONCLUSION: Face-to-face visits decreased early in the pandemic but increased after May 2020. Chiropractic telehealth use rapidly increased during the early stage of the COVID-19 pandemic, and decreased later, but remained slightly higher than pre-pandemic levels.

Veteran Response to Dosage in Chiropractic Therapy (VERDICT): Study Protocol of a Pragmatic Randomized Trial for Chronic Low Back Pain.

BACKGROUND: Low back pain is a leading cause of disability in veterans. Chiropractic care is a well-integrated, nonpharmacological therapy in Veterans Affairs health care facilities, where doctors of chiropractic provide therapeutic interventions focused on the management of low back pain and other musculoskeletal conditions. However, important knowledge gaps remain regarding the effectiveness of chiropractic care in terms of the number and frequency of treatment visits needed for optimal outcomes in veterans with low back pain. DESIGN: This pragmatic, parallel-group randomized trial at four Veterans Affairs sites will include 766 veterans with chronic low back pain who are randomly allocated to a course of low-dose (one to five visits) or higher-dose (eight to 12 visits) chiropractic care for 10 weeks (Phase 1). After Phase 1, participants within each treatment arm will again be randomly allocated to receive either monthly chiropractic chronic pain management for 10 months or no scheduled chiropractic visits (Phase 2). Assessments will be collected electronically. The Roland Morris Disability Questionnaire will be the primary outcome for Phase 1 at week 10 and Phase 2 at week 52. SUMMARY: This trial will provide evidence to guide the chiropractic dose in an initial course of care and an extended-care approach for veterans with chronic low back pain. Accurate information on the effectiveness of different dosing regimens of chiropractic care can greatly assist health care facilities, including Veterans Affairs, in modeling the number of doctors of chiropractic that will best meet the needs of patients with chronic low back pain.

Stakeholder Engagement in Pragmatic Clinical Trials: Emphasizing Relationships to Improve Pain Management Delivery and Outcomes.

BACKGROUND: The NIH-DOD-VA Pain Management Collaboratory (PMC) supports 11 pragmatic clinical trials (PCTs) on nonpharmacological approaches to management of pain and co-occurring conditions in U.S. military and veteran health organizations. The Stakeholder Engagement Work Group is supported by a separately funded Coordinating Center and was formed with the goal of developing respectful and productive partnerships that will maximize the ability to generate trustworthy, internally valid findings directly relevant to veterans and military service members with pain, front-line primary care clinicians and health care teams, and health system leaders. The Stakeholder Engagement Work Group provides a forum to promote success of the PCTs in which principal investigators and/or their designees discuss various stakeholder engagement strategies, address challenges, and share experiences. Herein, we communicate features of meaningful stakeholder engagement in the design and implementation of pain management pragmatic trials, across the PMC. DESIGN: Our collective experiences suggest that an optimal stakeholder-engaged research project involves understanding the following: i) Who are research stakeholders in PMC trials? ii) How do investigators ensure that stakeholders represent the interests of a study's target treatment population, including individuals from underrepresented groups?, and iii) How can sustained stakeholder relationships help overcome implementation challenges over the course of a PCT? SUMMARY: Our experiences outline the role of stakeholders in pain research and may inform future pragmatic trial researchers regarding methods to engage stakeholders effectively.

The Impact of Spinal Manipulation on Migraine Pain and Disability: A Systematic Review and Meta-Analysis.

BACKGROUND: Several small studies have suggested that spinal manipulation may be an effective treatment for reducing migraine pain and disability. We performed a systematic review and meta-analysis of published randomized clinical trials (RCTs) to evaluate the evidence regarding spinal manipulation as an alternative or integrative therapy in reducing migraine pain and disability. METHODS: PubMed and the Cochrane Library databases were searched for clinical trials that evaluated spinal manipulation and migraine-related outcomes through April 2017. Search terms included: migraine, spinal manipulation, manual therapy, chiropractic, and osteopathic. Meta-analytic methods were employed to estimate the effect sizes (Hedges' g) and heterogeneity (I2 ) for migraine days, pain, and disability. The methodological quality of retrieved studies was examined following the Cochrane Risk of Bias Tool. RESULTS: Our search identified 6 RCTs (pooled n = 677; range of n = 42-218) eligible for meta-analysis. Intervention duration ranged from 2 to 6 months; outcomes included measures of migraine days (primary outcome), migraine pain/intensity, and migraine disability. Methodological quality varied across the studies. For example, some studies received high or unclear bias scores for methodological features such as compliance, blinding, and completeness of outcome data. Due to high levels of heterogeneity when all 6 studies were included in the meta-analysis, the 1 RCT performed only among chronic migraineurs was excluded. Heterogeneity across the remaining studies was low. We observed that spinal manipulation reduced migraine days with an overall small effect size (Hedges' g = -0.35, 95% CI: -0.53, -0.16, P < .001) as well as migraine pain/intensity. CONCLUSIONS: Spinal manipulation may be an effective therapeutic technique to reduce migraine days and pain/intensity. However, given the limitations to studies included in this meta-analysis, we consider these results to be preliminary. Methodologically rigorous, large-scale RCTs are warranted to better inform the evidence base for spinal manipulation as a treatment for migraine.

Development of a Clinical Decision Aid for Chiropractic Management of Common Conditions Causing Low Back Pain in Veterans: Results of a Consensus Process.

OBJECTIVE: The purpose of this study was to develop a clinical decision aid for chiropractic management of common conditions causing low back pain (LBP) in veterans receiving treatment in US Veterans Affairs (VA) health care facilities. METHODS: A consensus study using an online, modified Delphi technique and Research Electronic Data Capture web application was conducted among VA doctors of chiropractic. Investigators reviewed the scientific literature pertaining to diagnosis and treatment of nonsurgical, neuromusculoskeletal LBP. Thirty seed statements summarizing evidence for chiropractic management, a graphical stepped management tool outlining diagnosis-informed treatment approaches, and support materials were then reviewed by an expert advisory committee. Email notifications invited 113 VA chiropractic clinicians to participate as Delphi panelists. Panelists rated the appropriateness of the seed statements and the stepped process on a 1-to-9 scale using the RAND/University of California, Los Angeles methodology. Statements were accepted when both the median rating and 80% of all ratings occurred within the highly appropriate range. RESULTS: Thirty-nine panelists (74% male) with a mean (standard deviation) age of 46 (11) years and clinical experience of 17 (11) years participated in the study. Accepted statements addressed included (1) essential components of chiropractic care, (2) treatments for conditions causing or contributing to LBP, (3) spinal manipulation mechanisms, (4) descriptions and mechanisms of commonly used chiropractic interventions, and (5) a graphical stepped clinical management tool. CONCLUSION: This study group produced a chiropractic clinical decision aid for LBP management, which can be used to support evidence-based care decisions for veterans with LBP.

Interprofessional Attitudes and Interdisciplinary Practices for Older Adults With Back Pain Among Doctors of Chiropractic: A Descriptive Survey.

OBJECTIVE: The purpose of this study is to report on attitudes of doctors of chiropractic (DCs) toward integrative medicine and their self-reported interdisciplinary practices for older adults with back pain. METHODS: This descriptive survey was conducted with licensed DCs in a Midwestern community in the United States. Respondents completed a 53-item postal survey of demographics, practice characteristics, referral and co-management patterns, attitudes toward interdisciplinary practice, and the Integrative Medicine-30 Questionnaire (IM-30). Descriptive statistical analysis was performed. RESULTS: Fifty-seven DCs completed the survey (29% response). Geriatric-focused chiropractic practices were uncommon (<15%), although 56% reported that 25% to 49% of the patients treated each week were older adults. Respondents had a moderate orientation toward collaboration with other health care providers (IM-30 mean [standard deviation] 61.3 [11.5]). The IM-30 subscales placed DCs high on measures of integrative medicine safety; moderate on patient-centeredness, openness to working with other providers, and referral readiness; and low on learning from alternative paradigms. Doctors of chiropractic most referred older patients to neurologists, family physicians, massage therapists, orthopedists, and other chiropractors. Doctors of chiropractic reported the highest levels of co-management with family physicians, physical therapists, and massage therapists. Most DCs (92%) were confident in their own ability to manage back pain in older adults, with modest confidence expressed for treatments from professionals using manual therapies. Most (77%) responded that older patients would experience the most improvement if DCs collaborated with another chiropractor, rather than with medical professionals. CONCLUSION: Doctors of chiropractic in one geographic community are moderately oriented toward interprofessional practice with other health care providers for older adults with back pain. Follow-up studies in representative national and international samples are recommended.

Effect of high-dose oral multivitamins and minerals in participants not treated with statins in the randomized Trial to Assess Chelation Therapy (TACT).

IMPORTANCE: In a prespecified subgroup analysis of participants not on statin therapy at baseline in the TACT, a high-dose complex oral multivitamins and multimineral regimen was found to have a large unexpected benefit compared with placebo. The regimen tested was substantially different from any vitamin regimen tested in prior clinical trials. OBJECTIVE: To explore these results, we performed detailed additional analyses of participants not on statins at enrollment in TACT. DESIGN: TACT was a factorial trial testing chelation treatments and a 28-component high-dose oral multivitamins and multiminerals regimen versus placebo in post-myocardial infarction (MI) patients 50 years or older. PARTICIPANTS: There were 460 (27%) of 1,708 TACT participants not taking statins at baseline, 224 (49%) were in the active vitamin group and 236 (51%) were in the placebo group. SETTING: Patients were enrolled at 134 sites around the United States and Canada. INTERVENTION: Daily high-dose oral multivitamins and multiminerals (6 tablets, active or placebo). MAIN OUTCOME: The primary end point of TACT was time to the first occurrence of any component of the composite end point: all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for angina. RESULTS: The primary end point occurred in 137 nonstatin participants (30%), of which 51 (23%) of 224 were in the active group and 86 (36%) of 236 were taking placebo (hazard ratio, 0.62; 95% confidence interval, 0.44-0.87; P=.006). Results in the key TACT secondary end point, a combination of cardiovascular mortality, stroke, or recurrent MI, was consistent in favoring the active vitamin group (hazard ratio, 0.46; 95% confidence interval, 0.28-0.75; P=.002). Multiple end point analyses were consistent with these results. CONCLUSION AND RELEVANCE: High-dose oral multivitamin and multimineral supplementation seem to decrease combined cardiac events in a stable, post-MI population not taking statin therapy at baseline. These unexpected findings are being retested in the ongoing TACT2.

Unique Review Criteria and Patient and Stakeholder Reviewers: Analysis of PCORI's Approach to Research Funding.

OBJECTIVE: The Patient-Centered Outcomes Research Institute (PCORI) uses a unique approach to Merit Review that includes patients and stakeholders as reviewers with scientists, and includes unique review criteria (patient-centeredness and active engagement of end users in the research). This study assessed the extent to which different reviewer types influence review scores and funding outcomes, the emphasis placed on technical merit compared to other criteria by a multistakeholder panel, and the impact of the in-person discussion on agreement among different reviewer types. METHODS: Cross-sectional analysis of administrative data from PCORI online and in-person Merit Review (N = 1312 applications from the five funding cycles from November 2013 to August 2015). Linear and logistic regression models were used to analyze the data. RESULTS: For all reviewer types, final review scores were associated with at least one review criterion score from each of the three reviewer types. The strongest predictor of final overall scores for all reviewer types was scientists' prediscussion ratings of technical merit. All reviewers' prediscussion ratings of the potential to improve health care and outcomes, and scientists' ratings of technical merit and patient-centeredness, were associated with funding success. For each reviewer type, overall impact scores from the online scoring were changed on at least half of the applications at the in-person panel discussion. Score agreement across reviewer types was greater after panel discussion. CONCLUSIONS: Scientist, patient, and stakeholder views all contribute to PCORI Merit Review of applications for research funding. Technical merit is critical to funding success but patient and stakeholder ratings of other criteria also influence application disposition.

Researchers, Patients, and Stakeholders Evaluating Comparative-Effectiveness Research: A Mixed-Methods Study of the PCORI Reviewer Experience.

OBJECTIVES: The Patient-Centered Outcomes Research Institute (PCORI) includes patients and stakeholders alongside scientists in reviewing research applications using unique review criteria including patient-centeredness and patient and/or stakeholder engagement. To support extension of this unique collaborative model to other funders, information from the reviewers on the review process is needed to understand how scientists and nonscientists evaluate research proposals together. Thus, this study aimed to describe reviewers' perspectives of the interactions during the in-person review panel; to examine the value and challenges of including scientists, patients, and stakeholders together; and to understand the perceived importance of PCORI's review criteria. METHODS: This study utilized anonymous, cross-sectional surveys (N = 925 respondents from 5 funding cycles: 470 scientists, 217 patients, 238 stakeholders; survey completion rates by cycle: 70-89%) and group interviews (N = 18). RESULTS: Reviewers of all types describe PCORI Merit Review as respectful, balanced, and one of reciprocal influence among different reviewer types. Reviewers indicate strong support and value of input from all reviewer types, receptivity to input from others, and the panel chair's incorporation of all views. Patients and stakeholders provide real-world perspectives on importance to patients, research partnership plans, and study feasibility. Challenges included concerns about a lack of technical expertise of patient/stakeholder reviewers and about scientists dominating conversations. The most important criterion for assigning final review scores was technical merit-either alone or in conjunction with patient-centeredness or patient/ stakeholder engagement. CONCLUSIONS: PCORI Merit Reviewers' self-reports indicate that the perspectives of different reviewer types are influential in panel discussions and Merit Review outcomes.

Opioid Use Among Veterans of Recent Wars Receiving Veterans Affairs Chiropractic Care.

Objective: To examine patient sociodemographic and clinical characteristics associated with opioid use among Veterans of Operations Enduring Freedom/Iraqi Freedom/New Dawn (OEF/OIF/OND) who receive chiropractic care, and to explore the relationship between timing of a chiropractic visit and receipt of an opioid prescription. Methods: Cross-sectional analysis of administrative data on OEF/OIF/OND veterans who had at least one visit to a Veterans Affairs (VA) chiropractic clinic between 2004 and 2014. Opioid receipt was defined as at least one prescription within a window of 90 days before to 90 days after the index chiropractic clinic visit. Results: We identified 14,025 OEF/OIF/OND veterans with at least one chiropractic visit, and 4,396 (31.3%) of them also received one or more opioid prescriptions. Moderate/severe pain (odds ratio [OR] = 1.87, 95% confidence interval [CI] = 1.72-2.03), PTSD (OR = 1.55, 95% CI = 1.41-1.69), depression (OR = 1.40, 95% CI = 1.29-1.53), and current smoking (OR = 1.39, 95% CI = 1.26-1.52) were associated with a higher likelihood of receiving an opioid prescription. The percentage of veterans receiving opioid prescriptions was lower in each of the three 30-day time frames assessed after the index chiropractic visit than before. Conclusions: Nearly one-third of OEF/OIF/OND veterans receiving VA chiropractic services also received an opioid prescription, yet the frequency of opioid prescriptions was lower after the index chiropractic visit than before. Further study is warranted to assess the relationship between opioid use and chiropractic care.

The Global Spine Care Initiative: resources to implement a spine care program.

PURPOSE: The purpose of this report is to describe the development of a list of resources necessary to implement a model of care for the management of spine-related concerns anywhere in the world, but especially in underserved communities and low- and middle-income countries. METHODS: Contents from the Global Spine Care Initiative (GSCI) Classification System and GSCI care pathway papers provided a foundation for the resources list. A seed document was developed that included resources for spine care that could be delivered in primary, secondary and tertiary settings, as well as resources needed for self-care and community-based settings for a wide variety of spine concerns (e.g., back and neck pain, deformity, spine injury, neurological conditions, pathology and spinal diseases). An iterative expert consensus process was used using electronic surveys. RESULTS: Thirty-five experts completed the process. An iterative consensus process was used through an electronic survey. A consensus was reached after two rounds. The checklist of resources included the following categories: healthcare provider knowledge and skills, materials and equipment, human resources, facilities and infrastructure. The list identifies resources needed to implement a spine care program in any community, which are based upon spine care needs. CONCLUSION: To our knowledge, this is the first international and interprofessional attempt to develop a list of resources needed to deliver care in an evidence-based care pathway for the management of people presenting with spine-related concerns. This resource list needs to be field tested in a variety of communities with different resource capacities to verify its utility. These slides can be retrieved under Electronic Supplementary Material.

The Global Spine Care Initiative: classification system for spine-related concerns.

PURPOSE: The purpose of this report is to describe the development of a classification system that would apply to anyone with a spine-related concern and that can be used in an evidence-based spine care pathway. METHODS: Existing classification systems for spinal disorders were assembled. A seed document was developed through round-table discussions followed by a modified Delphi process. International and interprofessional clinicians and scientists with expertise in spine-related conditions were invited to participate. RESULTS: Thirty-six experts from 15 countries participated. After the second round, there was 95% agreement of the proposed classification system. The six major classifications included: no or minimal symptoms (class 0); mild symptoms (i.e., neck or back pain) but no interference with activities (class I); moderate or severe symptoms with interference of activities (class II); spine-related neurological signs or symptoms (class III); severe bony spine deformity, trauma or pathology (class IV); and spine-related symptoms or destructive lesions associated with systemic pathology (class V). Subclasses for each major class included chronicity and severity when different interventions were anticipated or recommended. CONCLUSIONS: An international and interprofessional group developed a comprehensive classification system for all potential presentations of people who may seek care or advice at a spine care program. This classification can be used in the development of a spine care pathway, in clinical practice, and for research purposes. This classification needs to be tested for validity, reliability, and consistency among clinicians from different specialties and in different communities and cultures. These slides can be retrieved under Electronic Supplementary Material.