Public versus Private Care in the Military Health System: Evidence From Low Back Pain Patients.

INTRODUCTION: There is a longstanding debate about whether health care is more efficiently provided by the public or private sector. The debate is particularly relevant to the Military Health System (MHS), which delivers care through a combination of publicly funded federal facilities and privately contracted providers. This study compares outcomes, treatments, and costs for MHS patients obtaining care for low back pain (LBP) from public versus private providers. MATERIALS AND METHODS: A retrospective cohort study was completed using TRICARE Prime claims data from April 2015 to December 2018. The cohort was identified using International Classification of Diseases Ninth Revision and Tenth Revision diagnostic codes and then followed for 12 months after the index diagnosis to assess treatments, outcomes, and costs. Claims were classified as originating from either public or private providers. The primary outcome measure was resolution of LBP, defined as an absence of LBP diagnoses during the 6-to-12-month window following the index event. Instrumental variable models were used to assess the impact of care setting (i.e., private versus public), conditioning on the covariates. A regional measure of the fraction of private care was used as an instrument. RESULTS: Resolution of LBP was achieved for 79.7% of 144,866 patients in the cohort. No significant association was found between resolution of LBP and fraction of privately provided care. Higher fraction of private care was associated with a greater likelihood of opioid treatments (odds ratio, 1.22; 95% CI, 1.02-1.46) and a lower likelihood of benzodiazepine (odds ratio, 0.56; 95% CI, 0.45-0.70) and physical therapy (odds ratio 0.55; 95% CI, 0.42-0.74) treatments; manual therapy was not significantly associated with the fraction of private care. There was a significant negative association between the fraction of private care and cost (coefficient -0.27; 95% CI, -0.44, -0.10). CONCLUSION: This study found that privately provided care was associated with significantly higher opioid prescribing, less use of benzodiazepines and physical therapy, and lower costs. No systematic differences in outcomes (as measured by resolved cases) were identified. The findings suggest that publicly funded health care within the MHS context can attain quality comparable to privately provided care, although differences in treatment choices and costs point to possibilities for improved care within both systems.

Evaluation of "appropriate use criteria" for surgical decision-making in lumbar degenerative spondylolisthesis. A controlled, multicentre, prospective observational study.

INTRODUCTION: Selecting patients with lumbar degenerative spondylolisthesis (LDS) for surgery is difficult. Appropriate use criteria (AUC) have been developed to clarify the indications for LDS surgery but have not been evaluated in controlled studies. METHODS: This prospective, controlled, multicentre study involved 908 patients (561 surgical and 347 non-surgical controls; 69.5 ± 9.7y; 69% female), treated as per normal clinical practice. Their appropriateness for surgery was afterwards determined using the AUC. They completed the Core Outcome Measures Index (COMI) at baseline and 12 months' follow-up. Multiple regression adjusting for confounders evaluated the influence of appropriateness designation and treatment received on the 12-month COMI and achievement of MCIC (≥ 2.2-point-reduction). RESULTS: As per convention, appropriate (A) and uncertain (U) groups were combined for comparison with the inappropriate (I) group. For the adjusted 12-month COMI, the benefit of surgery relative to non-surgical care was not significantly greater for the A/U than the I group (p = 0.189). There was, however, a greater treatment effect of surgery for those with higher baseline COMI (p = 0.035). The groups' adjusted probabilities of achieving MCIC were: 83% (A/U, receiving surgery), 71% (I, receiving surgery), 50% (A/U, receiving non-surgical care), and 32% (I, receiving non-surgical care). CONCLUSIONS: A/U patients receiving surgery had the highest chances of achieving MCIC, but the AUC were not able to identify which patients had a greater treatment effect of surgery relative to non-surgical care. The identification of other characteristics that predict a greater treatment effect of surgery, in addition to baseline COMI, is required to improve decision-making.

A Regional Analysis of Low Back Pain Treatments in the Military Health System.

STUDY DESIGN: Claims-based analysis of cohorts of TRICARE Prime beneficiaries. OBJECTIVE: To compare rates of utilization of 5 low back pain (LBP) treatments (physical therapy (PT), manual therapy, behavioral therapies, opioid, and benzodiazepine prescription) across catchment areas and assess their association with the resolution of LBP. SUMMARY OF BACKGROUND: Guidelines support focusing on nonpharmacologic management for LBP and reducing opioid use. Little is known about patterns of care for LBP across the Military Health System. PATIENTS AND METHODS: Incident LBP diagnoses were identified data using the International Classification of Diseases ninth revision before October 2015 and 10th revision after October 2015; beneficiaries with "red flag" diagnoses and those stationed overseas, eligible for Medicare, or having other health insurance were excluded. After exclusions, there were 159,027 patients remained in the final analytic cohort across 73 catchment areas. Treatment was defined by catchment-level rates of treatment to avoid confounding by indication at the individual level; the primary outcome was the resolution of LBP defined as an absence of administrative claims for LBP during a 6 to 12-month period after the index diagnosis. RESULTS: Adjusted rates of opioid prescribing across catchment areas ranged from 15% to 28%, physical therapy from 17% to 39%, and manual therapy from 5% to 26%. Multivariate logistic regression models showed a negative and marginally significant association between opioid prescriptions and LBP resolution (odds ratio: 0.97, 95% CI: 0.93-1.00; P = 0.051) but no significant association with physical therapy, manual therapy, benzodiazepine prescription, or behavioral therapies. When the analysis was restricted to the subset of only active-duty beneficiaries, there was a stronger negative association between opioid prescription and LBP resolution (odds ratio: 0.93, 95% CI: 0.89-0.97). CONCLUSIONS: We found substantial variability across catchment areas within TRICARE for the treatment of LBP. Higher rates of opioid prescription were associated with worse outcomes.

Evaluation of the Clinical and Radiographic Degenerative Spondylolisthesis (CARDS) classification system as a guide to surgical technique selection.

BACKGROUND CONTEXT: The role of fusion in degenerative spondylolisthesis (DS) is controversial. The Clinical and Radiographic Degenerative Spondylolisthesis (CARDS) classification system was developed to assist surgeons in surgical technique selection based on individual patient characteristics. This system has not been clinically validated as a guide to surgical technique selection. PURPOSE: The purpose of this study was to determine if outcomes vary with different surgical techniques across the CARDS categories. STUDY DESIGN/SETTING: Prospective cohort study performed at one Swiss and one American spine center. PATIENT SAMPLE: Five hundred eight patients with DS undergoing surgical treatment. OUTCOME MEASURES: Core Outcomes Measure Index (COMI) at 3 months and 12 months postoperatively. METHODS: Patients undergoing surgery for DS were enrolled at 2 institutions and classified according to the CARDS system using dynamic radiographs. The Core Outcome Measure Index (COMI) was completed preoperatively, and 3 and 12 months postoperatively. Surgical technique was classified as uninstrumented (decompression alone or decompression with uninstrumented fusion) or instrumented (decompression with pedicle screw instrumentation with or without interbody fusion). Unadjusted analyses and mixed effect models compared COMI scores between the two surgery technique groups (uninstrumented vs instrumented), stratified by CARDS category over time. Reoperation rates were also compared between the surgery technique groups stratified by CARDS category. Partial funding was given through NASS grant for clinical research. RESULTS: Five hundred five out of 508 patients enrolled in the study had sufficient data to be classified according to CARDS. Seven percent were classified as CARDS A, 28% as CARDS B, 48% as CARDS C, and 17% as CARDS D (CARDS A most "stable," CARDS D least "stable"). One hundred and thirty-three patients (26%) underwent decompression alone, 30 (6%) underwent decompression and uninstrumented fusion, 42 (8%) underwent decompression and posterolateral instrumented fusion, and 303 (60%) underwent decompression with posterolateral and interbody instrumented fusion. Patients in the least "stable" categories tended to be less likely to be treated with an uninstrumented technique (CARDS D 19% vs 32% for the other categories, p=.10). There were no significant differences in 3 or 12-month COMI scores between surgical technique groups stratified by CARDS category in the unadjusted or adjusted analyses. In the unadjusted analyses, there was a trend towards less improvement in 12-month COMI change score in the CARDS D patients in the uninstrumented group compared to the instrumented group (-2.7 vs -4.1, p=.10). Reoperation rates were not significantly different between the surgical technique groups stratified by CARDS category. CONCLUSIONS: In general, outcomes for uninstrumented and instrumented surgical techniques were similar across the CARDS categories. Surgeons likely took factors included in CARDS into account during surgical technique selection. This resulted in a low number of CARDS D (n=15) patients being treated with uninstrumented techniques, which limited the statistical power of this analysis. As such, this study does not validate CARDS as a useful classification system for surgical technique selection in DS.

The association between cervical artery dissection and spinal manipulation among US adults.

PURPOSE: Cervical artery dissection (CeAD), which includes both vertebral artery dissection (VAD) and carotid artery dissection (CAD), is the most serious safety concern associated with cervical spinal manipulation (CSM). We evaluated the association between CSM and CeAD among US adults. METHODS: Through analysis of health claims data, we employed a case-control study with matched controls, a case-control design in which controls were diagnosed with ischemic stroke, and a case-crossover design in which recent exposures were compared to exposures in the same case that occurred 6-7 months earlier. We evaluated the association between CeAD and the 3-level exposure, CSM versus office visit for medical evaluation and management (E&M) versus neither, with E&M set as the referent group. RESULTS: We identified 2337 VAD cases and 2916 CAD cases. Compared to population controls, VAD cases were 0.17 (95% CI 0.09 to 0.32) times as likely to have received CSM in the previous week as compared to E&M. In other words, E&M was about 5 times more likely than CSM in the previous week in cases, relative to controls. CSM was 2.53 (95% CI 1.71 to 3.68) times as likely as E&M in the previous week among individuals with VAD than among individuals experiencing a stroke without CeAD. In the case-crossover study, CSM was 0.38 (95% CI 0.15 to 0.91) times as likely as E&M in the week before a VAD, relative to 6 months earlier. In other words, E&M was approximately 3 times more likely than CSM in the previous week in cases, relative to controls. Results for the 14-day and 30-day timeframes were similar to those at one week. CONCLUSION: Among privately insured US adults, the overall risk of CeAD is very low. Prior receipt of CSM was more likely than E&M among VAD patients as compared to stroke patients. However, for CAD patients as compared to stroke patients, as well as for both VAD and CAD patients in comparison with population controls and in case-crossover analysis, prior receipt of E&M was more likely than CSM.

Acceptability and Feasibility of Delivering Decision Aids to Veterans for Management of Knee Osteoarthritis - A Pilot Study.

Introduction: Decision aids are effective tools in facilitating patient-centered care and patient involvement in the decision-making process. Given unique barriers to providing patient-centered care for Veterans, implementation of decision aids may improve overall quality of care. We aimed to assess the acceptability and feasibility of video-based and pamphlet-based decision aid use in Veterans with knee osteoarthritis. Materials and Methods: Veterans considering treatment for knee osteoarthritis received either an online video-based aid, pamphlet-based aid, or both before their surgical consult. At their visit, patients completed written pre-visit and post-visit questionnaires. The pre-visit questionnaire included questions about the patient's demographics, decision-making preferences, experiences using the assigned decision aids, and the Hip-Knee Decision Quality Instrument. The post-visit questionnaire assessed the patient's overall experience with the decision-making process and how use of the decision aid influenced their discussion with the physician. Results: All 16 patients who received the pamphlet-based aid reviewed the decision aid before their visit, compared to only five of the 12 patients who received the video-based aid. Thirteen of 20 patients indicated that they preferred to share treatment decision-making with their physician. Seventeen of 20 patients believed they would feel comfortable questioning the treatment recommendation of their surgeon after decision aid use. Most patients reported a positive experience using their decision aid, regardless of modality, and found it easily comprehensible and useful in visit preparation. A preference for a pamphlet-based aid was expressed by the majority of patients. Conclusion: Veterans considering treatment for knee osteoarthritis are well prepared to engage in a patient-centered care experience. Most patients preferred sharing the decision-making process with their physician and felt comfortable questioning them about treatment recommendations. Decision aids helped Veterans feel more informed about their treatment options and improved engagement and discussion with their physician. Pamphlet-based aids were utilized more reliably than video-based aids.

Association between cervical artery dissection and spinal manipulative therapy -a medicare claims analysis.

BACKGROUND: Cervical artery dissection and subsequent ischemic stroke is the most serious safety concern associated with cervical spinal manipulation. METHODS: We evaluated the association between cervical spinal manipulation and cervical artery dissection among older Medicare beneficiaries in the United States. We employed case-control and case-crossover designs in the analysis of claims data for individuals aged 65+, continuously enrolled in Medicare Part A (covering hospitalizations) and Part B (covering outpatient encounters) for at least two consecutive years during 2007-2015. The primary exposure was cervical spinal manipulation; the secondary exposure was a clinical encounter for evaluation and management for neck pain or headache. We created a 3-level categorical variable, (1) any cervical spinal manipulation, 2) evaluation and management but no cervical spinal manipulation and (3) neither cervical spinal manipulation nor evaluation and management. The primary outcomes were occurrence of cervical artery dissection, either (1) vertebral artery dissection or (2) carotid artery dissection. The cases had a new primary diagnosis on at least one inpatient hospital claim or primary/secondary diagnosis for outpatient claims on at least two separate days. Cases were compared to 3 different control groups: (1) matched population controls having at least one claim in the same year as the case; (2) ischemic stroke controls without cervical artery dissection; and (3) case-crossover analysis comparing cases to themselves in the time period 6-7 months prior to their cervical artery dissection. We made each comparison across three different time frames: up to (1) 7 days; (2) 14 days; and (3) 30 days prior to index event. RESULTS: The odds of cervical spinal manipulation versus evaluation and management did not significantly differ between vertebral artery dissection cases and any of the control groups at any of the timepoints (ORs 0.84 to 1.88; p > 0.05). Results for carotid artery dissection cases were similar. CONCLUSION: Among Medicare beneficiaries aged 65 and older who received cervical spinal manipulation, the risk of cervical artery dissection is no greater than that among control groups.

Improving care for individuals with serious infections who inject drugs.

Background: Hospitalizations for serious infections requiring long-term intravenous (IV) antimicrobials related to injection drug use have risen sharply over the last decade. At our rural tertiary care center, opportunities for treatment of underlying substance use disorders were often missed during these hospital admissions. Once medically stable, home IV antimicrobial therapy has not traditionally been offered to this patient population due to theoretical concerns about misuse of long-term IV catheters, leading to discharges with suboptimal treatment regimens, lengthy hospital stays, or care that is incongruent with patient goals and preferences. Methods: A multidisciplinary group of clinicians and patients set out to redesign and improve care for this patient population through a health care innovation process, with a focus on increasing the proportion of patients who may be discharged on home IV therapy. Baseline assessment of current experience was established through retrospective chart review and extensive stakeholder analysis. The innovation process was based in design thinking and facilitated by a health care delivery improvement incubator. Results: The components of the resulting intervention included early identification of hospitalized people who inject drugs with serious infections, a proactive psychiatry consultation service for addiction management for all patients, a multidisciplinary care conference to support decision making around treatment options for infection and substance use, and care coordination/navigation in the outpatient setting with a substance use peer recovery coach and infectious disease nurse for patients discharged on home IV antimicrobials. Patients discharged on home IV therapy followed routine outpatient parenteral antimicrobial therapy (OPAT) protocols and treatment protocols for addiction with their chosen provider. Conclusion: An intervention developed through a design-thinking-based health care redesign process improved patient-centered care for people with serious infections who inject drugs.

Initial Choice of Spinal Manipulation Reduces Escalation of Care for Chronic Low Back Pain Among Older Medicare Beneficiaries.

STUDY DESIGN: We combined elements of cohort and crossover-cohort design. OBJECTIVE: The objective of this study was to compare longterm outcomes for spinal manipulative therapy (SMT) and opioid analgesic therapy (OAT) regarding escalation of care for patients with chronic low back pain (cLBP). SUMMARY OF BACKGROUND DATA: Current evidence-based guidelines for clinical management of cLBP include both OAT and SMT. For long-term care of older adults, the efficiency and value of continuing either OAT or SMT are uncertain. METHODS: We examined Medicare claims data spanning a five-year period. We included older Medicare beneficiaries with an episode of cLBP beginning in 2013. All patients were continuously enrolled under Medicare Parts A, B, and D. We analyzed the cumulative frequency of encounters indicative of an escalation of care for cLBP, including hospitalizations, emergency department visits, advanced diagnostic imaging, specialist visits, lumbosacral surgery, interventional pain medicine techniques, and encounters for potential complications of cLBP. RESULTS: SMT was associated with lower rates of escalation of care as compared to OAT. The adjusted rate of escalated care encounters was approximately 2.5 times higher for initial choice of OAT vs. initial choice of SMT (with weighted propensity scoring: rate ratio 2.67, 95% confidence interval 2.64-2.69, P < .0001). CONCLUSION: Among older Medicare beneficiaries who initiated long-term care for cLBP with opioid analgesic therapy, the adjusted rate of escalated care encounters was significantly higher as compared to those who initiated care with spinal manipulative therapy.Level of Evidence: 3.

Long-Term Medicare Costs Associated With Opioid Analgesic Therapy vs Spinal Manipulative Therapy for Chronic Low Back Pain in a Cohort of Older Adults.

OBJECTIVES: The purpose of this study was to compare Medicare healthcare expenditures for patients who received long-term treatment of chronic low back pain (cLBP) with either opioid analgesic therapy (OAT) or spinal manipulative therapy (SMT). METHODS: We conducted a retrospective observational study using a cohort design for analysis of Medicare claims data. The study population included Medicare beneficiaries enrolled under Medicare Parts A, B, and D from 2012 through 2016. We assembled cohorts of patients who received long-term management of cLBP with OAT or SMT (such as delivered by chiropractic or osteopathic practitioners) and evaluated the comparative effect of OAT vs SMT upon expenditures, using multivariable regression to control for beneficiary characteristics and measures of health status, and propensity score weighting and binning to account for selection bias. RESULTS: The study sample totaled 28,160 participants, of whom 77% initiated long-term care of cLBP with OAT, and 23% initiated care with SMT. For care of low back pain specifically, average long-term costs for patients who initiated care with OAT were 58% lower than those who initiated care with SMT. However, overall long-term healthcare expenditures under Medicare were 1.87 times higher for patients who initiated care via OAT compared with those initiated care with SMT (95% CI 1.65-2.11; P < .0001). CONCLUSIONS: Adults aged 65 to 84 who initiated long-term treatment for cLBP via OAT incurred lower long-term costs for low back pain but higher long-term total healthcare costs under Medicare compared with patients who initiated long-term treatment with SMT.

Orthopedic disease burden in adult patients with symptomatic lumbar scoliosis: results from a prospective multicenter study.

OBJECTIVE: Although the health impact of adult symptomatic lumbar scoliosis (ASLS) is substantial, these patients often have other orthopedic problems that have not been previously quantified. The objective of this study was to assess disease burden of other orthopedic conditions in patients with ASLS based on a retrospective review of a prospective multicenter cohort. METHODS: The ASLS-1 study is an NIH-sponsored prospective multicenter study designed to assess operative versus nonoperative treatment for ASLS. Patients were 40-80 years old with ASLS, defined as a lumbar coronal Cobb angle ≥ 30° and Oswestry Disability Index ≥ 20, or Scoliosis Research Society-22 questionnaire score ≤ 4.0 in pain, function, and/or self-image domains. Nonthoracolumbar orthopedic events, defined as fractures and other orthopedic conditions receiving surgical treatment, were assessed from enrollment to the 4-year follow-up. RESULTS: Two hundred eighty-six patients (mean age 60.3 years, 90% women) were enrolled, with 173 operative and 113 nonoperative patients, and 81% with 4-year follow-up data. At a mean (± SD) follow-up of 3.8 ± 0.9 years, 104 nonthoracolumbar orthopedic events were reported, affecting 69 patients (24.1%). The most common events were arthroplasty (n = 38), fracture (n = 25), joint ligament/cartilage repair (n = 13), and cervical decompression/fusion (n = 7). Based on the final adjusted model, patients with a nonthoracolumbar orthopedic event were older (HR 1.44 per decade, 95% CI 1.07-1.94), more likely to have a history of tobacco use (HR 1.63, 95% CI 1.00-2.66), and had worse baseline leg pain scores (HR 1.10, 95% CI 1.01-1.19). CONCLUSIONS: Patients with ASLS have high orthopedic disease burden, with almost 25% having a fracture or nonthoracolumbar orthopedic condition requiring surgical treatment during the mean 3.8 years following enrollment. Comparisons with previous studies suggest that the rate of total knee arthroplasty was considerably greater and the rates of total hip arthroplasty were at least as high in the ASLS-1 cohort compared with the similarly aged general US population. These conditions may further impact health-related quality of life and outcomes assessments of both nonoperative and operative treatment approaches in patients with ASLS.

Initial Choice of Spinal Manipulative Therapy for Treatment of Chronic Low Back Pain Leads to Reduced Long-term Risk of Adverse Drug Events Among Older Medicare Beneficiaries.

STUDY DESIGN: Retrospective observational study. OBJECTIVE: Opioid Analgesic Therapy (OAT) and Spinal Manipulative Therapy (SMT) are evidence-based strategies for treatment of chronic low back pain (cLBP), but the long-term safety of these therapies is uncertain. The objective of this study was to compare OAT versus SMT with regard to risk of adverse drug events (ADEs) among older adults with cLBP. SUMMARY OF BACKGROUND DATA: We examined Medicare claims data spanning a 5-year period on fee-for-service beneficiaries aged 65 to 84 years, continuously enrolled under Medicare Parts A, B, and D for a 60-month study period, and with an episode of cLBP in 2013. We excluded patients with a diagnosis of cancer or use of hospice care. METHODS: All included patients received long-term management of cLBP with SMT or OAT. We assembled cohorts of patients who received SMT or OAT only, and cohorts of patients who crossed over from OAT to SMT or from SMT to OAT. We used Poisson regression to estimate the adjusted incidence rate ratio for outpatient ADE among patients who initially chose OAT as compared with SMT. RESULTS: With controlling for patient characteristics, health status, and propensity score, the adjusted rate of ADE was more than 42 times higher for initial choice of OAT versus initial choice of SMT (rate ratio 42.85, 95% CI 34.16-53.76, P < 0.0001). CONCLUSION: Among older Medicare beneficiaries who received long-term care for cLBP the adjusted rate of ADE for patients who initially chose OAT was substantially higher than those who initially chose SMT.Level of Evidence: 2.

Operative versus nonoperative treatment for adult symptomatic lumbar scoliosis at 5-year follow-up: durability of outcomes and impact of treatment-related serious adverse events.

OBJECTIVE: Although short-term adult symptomatic lumbar scoliosis (ASLS) studies favor operative over nonoperative treatment, longer outcomes are critical for assessment of treatment durability, especially for operative treatment, because the majority of implant failures and nonunions present between 2 and 5 years after surgery. The objectives of this study were to assess the durability of treatment outcomes for operative versus nonoperative treatment of ASLS, to report the rates and types of associated serious adverse events (SAEs), and to determine the potential impact of treatment-related SAEs on outcomes. METHODS: The ASLS-1 (Adult Symptomatic Lumbar Scoliosis-1) trial is an NIH-sponsored multicenter prospective study to assess operative versus nonoperative ASLS treatment. Patients were 40-80 years of age and had ASLS (Cobb angle ≥ 30° and Oswestry Disability Index [ODI] ≥ 20 or Scoliosis Research Society [SRS]-22 subscore ≤ 4.0 in the Pain, Function, and/or Self-Image domains). Patients receiving operative and nonoperative treatment were compared using as-treated analysis, and the impact of related SAEs was assessed. Primary outcome measures were ODI and SRS-22. RESULTS: The 286 patients with ASLS (107 with nonoperative treatment, 179 with operative treatment) had 2-year and 5-year follow-up rates of 90% (n = 256) and 74% (n = 211), respectively. At 5 years, compared with patients treated nonoperatively, those who underwent surgery had greater improvement in ODI (mean difference -15.2 [95% CI -18.7 to -11.7]) and SRS-22 subscore (mean difference 0.63 [95% CI 0.48-0.78]) (p < 0.001), with treatment effects (TEs) exceeding the minimum detectable measurement difference (MDMD) for ODI (7) and SRS-22 subscore (0.4). TEs at 5 years remained as favorable as 2-year TEs (ODI -13.9, SRS-22 0.52). For patients in the operative group, the incidence rates of treatment-related SAEs during the first 2 years and 2-5 years after surgery were 22.38 and 8.17 per 100 person-years, respectively. At 5 years, patients in the operative group who had 1 treatment-related SAE still had significantly greater improvement, with TEs (ODI -12.2, SRS-22 0.53; p < 0.001) exceeding the MDMD. Twelve patients who received surgery and who had 2 or more treatment-related SAEs had greater improvement than nonsurgically treated patients based on ODI (TE -8.34, p = 0.017) and SRS-22 (TE 0.32, p = 0.029), but the SRS-22 TE did not exceed the MDMD. CONCLUSIONS: The significantly greater improvement of operative versus nonoperative treatment for ASLS at 2 years was durably maintained at the 5-year follow-up. Patients in the operative cohort with a treatment-related SAE still had greater improvement than patients in the nonoperative cohort. These findings have important implications for patient counseling and future cost-effectiveness assessments.

Temporal Trends and Geographic Variations in the Supply of Clinicians Who Provide Spinal Manipulation to Medicare Beneficiaries: A Serial Cross-Sectional Study.

OBJECTIVE: Spinal manipulation (SM) is recommended for first-line treatment of patients with low back pain. Inadequate access to SM may result in inequitable spine care for older US adults, but the supply of clinicians who provide SM under Medicare is uncertain. The purpose of this study was to measure temporal trends and geographic variations in the supply of clinicians who provide SM to Medicare beneficiaries. METHODS: Medicare is a US government-administered health insurance program that provides coverage primarily for older adults and people with disabilities. We used a serial cross-sectional design to examine Medicare administrative data from 2007 to 2015 for SM services identified by procedure code. We identified unique providers by National Provider Identifier and distinguished between chiropractors and other specialties by Physician Specialty Code. We calculated supply as the number of providers per 100 000 beneficiaries, stratified by geographic location and year. RESULTS: Of all clinicians who provide SM to Medicare beneficiaries, 97% to 98% are doctors of chiropractic. The geographic supply of doctors of chiropractic providing SM services in 2015 ranged from 20/100 000 in the District of Columbia to 260/100 000 in North Dakota. The supply of other specialists performing the same services ranged from fewer than 1/100 000 in 11 states to 8/100 000 in Colorado. Nationally, the number of Medicare-active chiropractors declined from 47 102 in 2007 to 45 543 in 2015. The count of other clinicians providing SM rose from 700 in 2007 to 1441 in 2015. CONCLUSION: Chiropractors constitute the vast majority of clinicians who bill for SM services to Medicare beneficiaries. The supply of Medicare-active SM providers varies widely by state. The overall supply of SM providers under Medicare is declining, while the supply of nonchiropractors who provide SM is growing.

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.

Differences in Functional Treadmill Tests in Patients With Adult Symptomatic Lumbar Scoliosis Treated Operatively and Nonoperatively.

STUDY DESIGN: Prospective longitudinal cohort. OBJECTIVES: The aim of this study was to determine whether functional treadmill testing (FTT) demonstrates differences between patients treated operatively and nonoperatively for adult symptomatic lumbar scoliosis (ASLS). SUMMARY OF BACKGROUND DATA: ASLS has become increasingly prevalent as the population ages. ASLS can be accompanied by neurogenic claudication, leading to difficulty walking. FTT may provide a functional tool to evaluate patients with ASLS. METHODS: One hundred and eighty-seven patients who underwent nonoperative (n = 88) or operative treatment (n = 99) of ASLS with complete baseline and 2-year post-treatment FTTs and concurrent patient-reported outcomes were identified. FTT parameters included maximum speed, time to onset of symptoms, distance ambulated, time ambulated, and Back and Leg pain severity before and after testing. RESULTS: At baseline, patients treated operatively reported worse post-FTT back pain (4.39 vs. 3.45, P = 0.032) than those treated nonoperatively, despite similar ODI, SRS-22 Pain and Activity domain scores. Mean time ambulated (+2.15 vs. -1.20 P = 0.001), pre-FTT back pain (+0.19 vs. -1.60, P < 0.000) and leg pain (+0.25 vs. -0.54, P = 0.024) improved in the operative group but deteriorated in the nonoperative group. On the 2-year follow-up FTT, both groups showed improvement in post-FTT back pain (-0.53 vs. -2.64, P < 0.000) and leg pain (-0.13 vs. -1.54, P = 0.001) severity but the improvement was statistically significantly greater in the operative compared to the nonoperative group. CONCLUSION: FTT results at baseline were worse in patients treated operatively than those treated non-operatively. FTT may be a useful adjunct to assess treatment outcomes in patients with ASLS and may help surgeons counsel patients regarding expectations 2 years after operative or nonoperative treatment for ASLS. At 2-year follow-up, time ambulated deteriorated in patients treated nonoperatively but improved in patients treated operatively. Although both groups showed improvement in post-FTT Back and Leg pain at 2 years, the improvement was greater in the operative compared to the nonoperative group. LEVEL OF EVIDENCE: 2.

Epidural Steroid Injections for Management of Degenerative Spondylolisthesis: Little Effect on Clinical Outcomes in Operatively and Nonoperatively Treated Patients.

BACKGROUND: Although epidural steroid injection (ESI) may provide pain relief for patients with degenerative spondylolisthesis in treatment regimens of up to 4 months, it remains unclear whether ESI affects crossover from nonoperative to operative management. METHODS: This retrospective cohort study analyzed 2 groups of surgical candidates with degenerative spondylolisthesis: those who received ESI within 3 months after enrollment (ESI group) and those who did not (no-ESI group). Annual outcomes following enrollment were assessed within operative and nonoperative groups (patients who initially chose or were assigned to surgery or nonoperative treatment) by using longitudinal mixed-effect models with a random subject intercept term accounting for correlations between repeated measurements. Treatment comparisons were performed at follow-up intervals. Area-under-the-curve analysis for all time points assessed the global significance of treatment. RESULTS: The study included 192 patients in the no-ESI group and 74 in the ESI group. The no-ESI group had greater baseline Short Form-36 (SF-36) Bodily Pain scores (median, 35 versus 32) and self-reported preference for surgery (38% versus 11%). There were no differences in surgical rates within 4 years after enrollment between the no-ESI and ESI groups (61% versus 62%). The surgical ESI and no-ESI groups also showed no differences in changes in patient-reported outcomes at any follow-up interval or in the 4-year average. Compared with the nonoperative ESI group, the nonoperative no-ESI group showed greater improvements in SF-36 scores for Bodily Pain (p = 0.004) and Physical Function (p = 0.005) at 4 years, Bodily Pain at 1 year (p = 0.002) and 3 years (p = 0.005), and Physical Function at 1 year (p = 0.030) and 2 years (p = 0.002). Of the patients who were initially treated nonsurgically, those who received ESI and those who did not receive ESI did not differ with regard to surgical crossover rates. The rates of crossover to nonoperative treatment by patients who initially chose or were assigned to surgery also did not differ between the ESI and no-ESI groups. CONCLUSIONS: There was no relationship between ESI and improved clinical outcomes over a 4-year study period for patients who chose or were assigned to receive surgery for degenerative spondylolisthesis. In the nonsurgical group, ESI was associated with inferior pain reduction through 3 years, although this was confounded by greater baseline pain. ESI showed little relationship with surgical crossover. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Cost-effectiveness of adult lumbar scoliosis surgery: an as-treated analysis from the adult symptomatic scoliosis surgery trial with 5-year follow-up.

STUDY DESIGN: Longitudinal comparative cohort. OBJECTIVE: The purpose of this study is to report on the cost-effectiveness of surgical versus non-surgical treatment for Adult Symptomatic Lumbar Scoliosis (ASLS) using the as-treated data and provide a comparison to previously reported intent-to-treat (ITT) analysis. Adult spinal deformity is a relatively prevalent condition for which surgical treatment has become increasingly common but concerns surrounding complications, revision rates and cost-effectiveness remain unresolved. Of these issues, cost-effectiveness is perhaps the most difficult to quantify as the requisite data is difficult to obtain. The purpose of this study is to report on the cost-effectiveness of surgical versus non-surgical treatment for ASLS using the as-treated data and provide a comparison to previously reported ITT analysis. METHODS: Patients with at least 5-year follow-up data within the same treatment arm were included. Data collected every 3 months included use of nonoperative modalities, medications and employment status. Costs for surgeries and non-operative modalities were determined using Medicare Allowable rates. Medication costs were determined using the RedBook and indirect costs were calculated based on the reported employment status and income. Quality-Adjusted Life Years (QALY) was determined using the SF-6D. RESULTS: Of 226 patients, 195 patients (73 Non-op, 122 Op) met inclusion criteria. At 5 years, 29 (24%) patients in the Op group had a revision surgery of whom two had two revisions and one had three revisions. The cumulative cost for the Op group was $111,451 with a cumulative QALY gain of 2.3. The cumulative cost for the Non-Op group was $29,124 with a cumulative QALY gain of 0.4. This results in an ICER of $44,033 in favor of Op treatment. CONCLUSION: This as-treated cost-effectiveness analysis demonstrates that surgical treatment for adult lumbar scoliosis becomes favorable at year-three, 1 year earlier than suggested by a previous intent-to-treat analysis. LEVEL OF EVIDENCE: II.

Longitudinal Spending on Endovascular and Open Abdominal Aortic Aneurysm Repair.

BACKGROUND: Endovascular repair (EVR) has replaced open surgery as the procedure of choice for patients requiring elective abdominal aortic aneurysm (AAA) repair. Long-term outcomes of the 2 approaches are similar, making the relative cost of caring for these patients over time an important consideration. METHODS AND RESULTS: We linked Medicare claims to Vascular Quality Initiative registry data for patients undergoing elective EVR or open AAA repair from 2004 to 2015. The primary outcome was Medicare's cumulative disease-related spending, adjusted to 2015 dollars. Disease-related spending included the index operation and associated hospitalization, surveillance imaging, reinterventions (AAA-related and abdominal wall procedures), and all-cause admissions within 90 days. We compared the incidence of disease-related events and cumulative spending at 90 days and annually through 7 years of follow-up. The analytic cohort comprised 6804 EVR patients (median follow-up: 1.85 years; interquartile range: 0.82-3.22 years) and 1889 open repair patients (median follow-up: 2.62 years; interquartile range: 1.13-4.80 years). Spending on index surgery was significantly lower for EVR (median [interquartile range]: $25 924 [$22 280-$32 556] EVR versus $31 442 [$24 669-$40 419] open; P<0.001), driven by a lower rate of in-hospital complications (6.6% EVR versus 38.0% open; P<0.001). EVR patients underwent more surveillance imaging (1.8 studies per person-year EVR versus 0.7 studies per person-year open; P<0.001) and AAA-related reinterventions (4.0 per 100 person-years EVR versus 2.1 per 100 person-years open; P=0.041). Open repair patients had higher rates of 90-day readmission (12.9% EVR versus 17.8% open; P<0.001) and abdominal wall procedures (0.6 per 100 person-years EVR versus 1.5 per 100 person-years open; P<0.001). Overall, EVR patients incurred more disease-related spending in follow-up ($7355 EVR versus $2706 open through 5 years). There was no cumulative difference in disease-related spending between surgical groups by 5 years of follow-up (-$33 EVR [95% CI: -$1543 to $1476]). CONCLUSIONS: We observed no cumulative difference in disease-related spending on EVR and open repair patients 5 years after surgery. Generalized recommendations about which approach to offer elective AAA patients should not be based on relative cost.