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Clifford A Reilly,1 Makenna L Rice,2 Dylan J Parker,2 Philip P Goodney,3– 6 Jon D Lurie,3,4 Said A Ibrahim,7,8 Eric R Henderson2,4,6 1Larner College of Medicine, University of Vermont, Burlington, VT, USA; 2Department of Orthopaedic Surgery, Dartmouth Hitchcock Medical Center, Lebanon, NH, USA; 3The Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College, Hanover, NH, USA; 4Geisel School of Medicine, Dartmouth College, Hanover, NH, USA; 5Heart and Vascular Center, Dartmouth Hitchcock Medical Center, Lebanon, NH, USA; 6White River Junction VA Medical Center, US Department of Veterans Affairs, White River Junction, VT, USA; 7Zucker School of Medicine, Hofstra University/Northwell Health, Hempstead, NY, USA; 8Department of Medicine, Long Island Jewish Medical Center, New Hyde Park, NY, USACorrespondence: Makenna L Rice, Department of Orthopaedic Surgery, Dartmouth Hitchcock Medical Center, 1 Medical Center Dr, Rubin 592, Lebanon, NH, 03756, USA, Tel +1 831 247-1106, Fax +1 603 653-3581, Email Makenna.L.Rice@hitchcock.orgIntroduction: 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.Keywords: patient-centered care, shared decision-making, decision aid, knee osteoarthritis, military service

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.

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.

Conflicts of interest: No potential conflicts exist for any author listed.Abstract 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.

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

STUDY DESIGN: Longitudinal Comparative Cohort OBJECTIVE: The purpose of this study is to report on the cost-effectiveness of surgical versus nonsurgical treatment for Adult Symptomatic Lumbar Scoliosis (ASLS) using the as-treated data and provide a comparison to previously reported intent-to-treat (ITT) analysis. SUMMARY OF BACKGROUND DATA: 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 nonsurgical treatment for Adult Symptomatic Lumbar Scoliosis (ASLS) using the as-treated data and provide a comparison to previously reported intent-to-treat (ITT) analysis. METHODS: Patients with at least five-year follow-up data within the same treatment arm were included. Data collected every three 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 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 five 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, one year earlier than suggested by a previous intent-to-treat analysis. LEVEL OF EVIDENCE: II

OBJECTIVEAdult symptomatic lumbar scoliosis (ASLS) is a common and disabling condition. The ASLS-1 was a multicenter, dual-arm study (with randomized and observational cohorts) examining operative and nonoperative care on health-related quality of life in ASLS. An aim of ASLS-1 was to determine patient and radiographic factors that modify the effect of operative treatment for ASLS.METHODSPatients 40–80 years old with ASLS were enrolled in randomized and observational cohorts at 9 North American centers. Primary outcomes were the differences in mean change from baseline to 2-year follow-up for the SRS-22 subscore (SRS-SS) and the Oswestry Disability Index (ODI). Analyses were performed using an as-treated approach with combined cohorts. Factors examined were prespecified or determined using regression tree analysis. For each potential effect modifier, subgroups were created using clinically relevant cutoffs or via regression trees. Estimates of within-group and between-group change were compared using generalized linear mixed models. An effect modifier was defined as a treatment effect difference greater than the minimal detectable measurement difference for both SRS-SS (0.4) and ODI (7).RESULTSTwo hundred eighty-six patients were enrolled and 256 (90%) completed 2-year follow-up; 171 received operative treatment and 115 received nonoperative treatment. Surgery was superior to nonoperative care for all effect subgroups considered, with the exception of those with nearly normal pelvic incidence−lumbar lordosis (PI–LL) match (≤ 11°). Male patients and patients with more (> 11°) PI–LL mismatch at baseline had greater operative treatment effects on both the SRS-SS and ODI compared to nonoperative treatment. No other radiographic subgroups were associated with treatment effects. High BMI, lower socioeconomic status, and poor mental health were not related to worse outcomes.CONCLUSIONSNumerous factors previously related to poor outcomes with surgery, such as low mental health, lower socioeconomic status, and high BMI, were not related to outcomes in ASLS in this exploratory analysis. Those patients with higher PI–LL mismatch did improve more with surgery than those with normal alignment. On average, none of the factors considered were associated with a worse outcome with operative treatment versus nonoperative treatment. These findings may guide future prospective analyses of factors related to outcomes in ASLS care.

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.

Study design We combined elements of cohort and crossover-cohort design. Objective The objective of this study was to compare long-term 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% CI 2.64-2.69, p Conclusions 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.

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 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.

STUDY DESIGN Secondary analysis of prospective multicenter cohort. OBJECTIVE To assess effect of serious adverse events (SAEs) on 2- and 4-year patient-reported outcomes measures (PROMs) in patients surgically treated for adult symptomatic lumbar scoliosis (ASLS). SUMMARY OF BACKGROUND DATA Operative treatment for ASLS can improve health-related quality of life, but has high rates of SAEs. How these SAEs effect health-related quality of life remain unclear. METHODS The ASLS study assessed operative versus nonoperative ASLS treatment, with randomized and observational arms. Patients were 40- to 80-years-old with ASLS, defined as lumbar coronal Cobb ≥30° and Oswestry Disability Index (ODI) ≥20 or Scoliosis Research Society-22 (SRS-22) ≤4.0 in pain, function, and/or self-image domains. SRS-22 subscore and ODI were compared between operative patients with and without a related SAE and nonoperative patients using an as-treated analysis combining randomized and observational cohorts. RESULTS Two hundred eighty-six patients were enrolled, and 2- and 4-year follow-up rates were 90% and 81%, respectively, although at the time of data extraction not all patients were eligible for 4-year follow-up. A total of 97 SAEs were reported among 173 operatively treated patients. The most common were implant failure/pseudarthrosis (n = 25), proximal junctional kyphosis/failure (n = 10), and minor motor deficit (n = 8). At 2 years patients with an SAE improved less than those without an SAE based on SRS-22 (0.52 vs. 0.79, P = 0.004) and ODI (-11.59 vs. -17.34, P = 0.021). These differences were maintained at 4-years for both SRS-22 (0.51 vs. 0.86, P = 0.001) and ODI (-10.73 vs. -16.69, P = 0.012). Despite this effect, patients sustaining an operative SAE had greater PROM improvement than nonoperative patients (P

BACKGROUND CONTEXT Lumbar disc herniation and retrolisthesis have been shown to be significant degenerative changes that can be associated with back pain. Current literature has shown evidence that retrolisthesis is associated with similar baseline function in patients with L5–S1 disc herniation, but worse postoperative outcomes 2 years after lumbar discectomy. However, literature comparing long-term postoperative outcomes at 8-year follow-up in patients with L5–S1 disc herniation with retrolisthesis is lacking. PURPOSE The purpose of the present study is to compare long-term postoperative outcomes at 8-year follow-up in patients with retrolisthesis and L5–S1 disc herniations to patients with L5–S1 disc herniations without retrolisthesis. STUDY DESIGN Retrospective review of prospectively collected data from the Spine Patients Outcomes Research Trial (SPORT) database. PATIENT SAMPLE Sixty-five patients who underwent lumbar discectomy for L5–S1 disc herniations with 8-year follow-up from the SPORT. OUTCOME MEASURES Short Form (SF)-36 bodily pain scale, SF-36 physical function scale, Oswestry Disability Index, Sciatica Bothersomeness Index, and reoperation rate. METHODS Baseline surgical parameters, length of stay, complication rates, reoperation rates, and outcome measures were recorded in the SPORT database. Follow-up data were collected at 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, and 8 years. Retrolisthesis was defined as posterior subluxation ≥8%. Patients with and without retrolisthesis were compared using a mixed-effects model of longitudinal regression. Outcomes were calculated as time-weighted averages over 8 years. Reoperation rates were compared using the log-rank test based on time to first reoperation. RESULTS One hundred-twenty five patients met inclusion criteria for the present study, including 29 patients with retrolisthesis (23.3%) and 96 patients who did not have retrolisthesis (76.7%). The greatest difference in clinical outcome measures was found at 2 years postoperatively. This was the only point at which both the Short Form-36 Bodily Pain scale (SF-36 BP) and PF showed significant differences between the retrolisthesis and nonretrolisthesis group. At 3 years, SF-36 BP was significantly lower in patients with retrolisthesis (39.9 vs. 52, p=.046). At 8-year follow-up, the presence of retrolisthesis in patients undergoing L5–S1 discectomy was not associated with worse outcome measure scores based on the area under the curve analysis for any metric investigated (SF-36 BP 41.4 vs. 47.1, p=.18; SF-36 Physical Function scale 38.9 vs. 45.4, p=.12; Oswestry Disability Index −39.4 vs. −34.8, p=.23; −11.6 vs. −10.4, p=.25) or a difference in reoperation rate (retrolisthesis group 10%, nonretrolisthesis group 17%, p=.41). CONCLUSIONS While retrolisthesis can contribute to low back pain and dysfunction in patients undergoing lumbar discectomy for L5–S1 herniated nucleus pulposus in early follow-up, no significant difference was found in postoperative outcomes after 3 years. Additionally, retrolisthesis was not found to be associated with different reoperation rates at 8 years postoperatively.

UpdateThis article was updated on November 12, 2019, because of a previous error. On page 349, in Table VII, the column heads “2 Yr”, “Mean Change from Baseline (SE)”, “Difference in Mean Change (95% CI)”, and “P Value” that had been aligned with the content in the second to fourth columns have now

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 subjects, 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 as compared to those initiated care with SMT (95% CI 1.65-2.11; p

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.

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 P P P =0.041). Open repair patients had higher rates of 90-day readmission (12.9% EVR versus 17.8% open; P P 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.

STUDY DESIGN A retrospective cohort study. OBJECTIVE The objective of this study was to determine if patient satisfaction is predicted by improvement in health-related quality of life (HRQOL) metrics. SUMMARY OF BACKGROUND DATA Patient satisfaction is becoming an increasingly common proxy for treatment quality; however, the correlation between patient satisfaction and HRQOL outcome metrics following a lumbar disk herniation is unclear. METHODS Patients enrolled in the Spine Patient Outcomes Research Trial (SPORT) study were prospectively enrolled at 13 institutions. A retrospective subgroup analysis of prospectively collected data from the SPORT trial was performed. Receiver operating characteristic curves were used to determine if improvement in HRQOL metrics could accurately identify patient satisfaction. HRQOL metrics included: Short Form-36 (SF-36), Oswestry Disability Index (ODI), Sciatica Bothersomeness Index, Back Pain Bothersomeness Scale, and Leg Pain Bothersomeness Scale. RESULTS A total of 709 patients who underwent surgery and 319 patients treated without surgery were included. In the surgical cohort, receiver operating characteristic curve analysis demonstrated that SF-36 Physical Component Summary improvement had moderate accuracy [area under the curve (AUC)=0.77 (95% confidence interval, CI: 0.73-0.82)] at predicting satisfaction at 3 months, and it had excellent accuracy at predicting satisfaction at 2 years [AUC=0.81 (95% CI: 0.77-0.85)] and 4 years [AUC=0.81 (95% CI: 0.76-0.85)]. Absolute Physical Component Summary score had excellent accuracy at 3 months [AUC=0.83 (95% CI: 0.79-0.87)], 2 years [AUC=0.87 (95% CI: 0.84-0.9)] and 4 years [AUC=0.84 (95% CI: 0.8-0.89)]. Similarly improvement in the ODI had moderate accuracy of predicting satisfaction at 3 months [AUC=0.77 (95% CI: 0.72-0.81)], 2 years [AUC=0.78 (95% CI: 0.74-0.82)] and 4 years [AUC=0.78 (95% CI: 0.73-0.83)], and the absolute ODI score had excellent accuracy at 3 months [AUC=0.85 (95% CI: 0.82-0.89)], 2 years [AUC=0.89 (95% CI: 0.86-0.92)], and 4 years [AUC=0.88 (95% CI: 0.85-0.92)]. CONCLUSIONS HRQOL metrics can accurately predict patient satisfaction with symptoms at 3 months, 2 years, and 4 years after surgical intervention for a lumbar disk herniation. Absolute outcome scores were somewhat more predictive than change scores.

Randomized trial with a concurrent observational cohort study.To compare 8-year outcomes between surgery and nonoperative care and among different fusion techniques for symptomatic lumbar degenerative spondylolisthesis (DS).Surgical treatment of DS has been shown to be more effective than nonoperative treatment out to 4 years. This study sought to further determine the long-term (8-year) outcomes.Surgical candidates with DS from 13 centers with at least 12 weeks of symptoms and confirmatory imaging were offered enrollment in a randomized controlled trial (RCT) or observational cohort study (OBS). Treatment consisted of standard decompressive laminectomy (with or without fusion) versus standard nonoperative care. Primary outcome measures were the Short Form-36 (SF-36) bodily pain and physical function scores and the modified Oswestry Disability Index at 6 weeks, 3 months, 6 months, and yearly up to 8 years.Data were obtained for 69% of the randomized cohort and 57% of the observational cohort at the 8-year follow up. Intent-to-treat analyses of the randomized group were limited by high levels of nonadherence to the randomized treatment. As-treated analyses in the randomized and observational groups showed significantly greater improvement in the surgery group on all primary outcome measures at all time points through 8 years. Outcomes were similar among patients treated with uninstrumented posterolateral fusion, instrumented posterolateral fusion, and 360° fusion.For patients with symptomatic DS, patients who received surgery had significantly greater improvements in pain and function compared with nonoperative treatment through 8 years of follow-up. Fusion technique did not affect outcomes.1.

Background Decision quality measures the degree to which care decisions are knowledge-based and value-aligned. Because military service emphasizes hierarchy, command, and mandates some healthcare decisions, military service may attenuate patient autonomy in healthcare decisions and lower decision quality. VA is the nation's largest provider of orthopedic care. We compared decision quality in a sample of VA and non-VA patients seeking care for knee osteoarthritis. Methods Our study sample consisted of patients newly referred to our orthopedic clinic for the management of knee osteoarthritis. None of the study patients were exposed to a knee osteoarthritis decision aid. Consenting patients were administered the Hip/Knee Decision Quality Instrument (HK-DQI). In addition, they were surveyed about decision-making preferences and demographics. We compared results to a non-VA cohort from our academic institution's arthroplasty database. Results The HK-DQI Knowledge Score was lower in the VA cohort (45%, SD = 22, n = 25) compared with the non-VA cohort (53%, SD = 21, n = 177) (p = 0.04). The Concordance Score was lower in the VA cohort (36%, SD = 49%) compared with the control cohort (70%, SD 46%) (p = 0.003). Non-VA patients were more likely to make a high-quality decision (p = 0.05). Non-VA patients were more likely to favor a shared decision-making process (p = 0.002). Conclusions Decision quality is lower in Veterans with knee osteoarthritis compared with civilians, placing them at risk for lower treatment satisfaction and possibly unwarranted surgical utilization. Our future work will examine if this difference is from conditioned military service behaviors or confounding demographic factors, and if conventional shared decision-making techniques will correct this deficiency.

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.

Retrospective cohort.To examine Charlson Comorbidity Index (CCMI) as a marker for deterioration in health status not reflected in standard Health Related Quality of Life (HRQOL) measures.HRQOL has become a primary metric for assessing outcomes following spinal deformity surgery. However, studies have reported limited impact of complications on postoperative HRQOL outcomes.We examined serial CCMI, complications, and HRQOL outcomes for 138 adult lumbar deformity patients treated surgically with a minimum two-year follow-up that included 126 females (91%) with a mean age of 59.8 years (range, 40.2-78.5). Patients with no, minor, or major complications were compared at baseline and at one and two years postoperation.Minor complications were observed in 26 patients (19%) and major complications in 15 (11%). Major complications included motor deficit (7), deep vein thrombosis (4), and respiratory failure (3). There was no difference in preoperative SF-36 Physical Component Summary or Scoliosis Research Society-22R (SRS-22R) scores among the groups at baseline. Preoperative CCMI was lowest in the No Complication group (3.52 ± 1.70) followed by the Major (4.00 ± 1.13) and Minor Complication groups (4.15 ± 1.71, p = .165). At one year, there was a significantly greater CCMI deterioration in the Major Complication group (0.80 ± 1.01) compared to both the Minor (0.08 ± 0.27) and No Complication groups (0.27 ± 0.47, p.001). There was no significant difference in SF-36 Physical Component Summary or SRS-22R scores among the three groups. Similar findings were observed at two years.Despite similar one- and two-year HRQOL improvement, patients with major complications had greater deterioration in CCMI. As CCMI is predictive of medical and surgical risk, patients who sustained a major complication now carry a greater likelihood of adverse outcomes with future interventions, including any subsequent spinal surgery. Although this increased risk may not alter the patient's perception of his or her current health status, it may be important, and should be recognized as part of the shared decision-making process.Level II, high-quality prognostic study.

Study design Retrospective analysis of prospective data from the degenerative spondylolisthesis (DS) arm of the Spine Patient Outcomes Research Trial. Objective The aim of this study was to identify risk factors for reoperation in patients treated surgically for DS and compare outcomes between patients who underwent reoperation with nonreoperative patients. Summary of background data Several studies have examined outcomes following surgery for DS, but few have identified risk factors for reoperation. Methods Analysis included patients with neurogenic claudication (>12 weeks), clinical neurological signs, spinal stenosis, and DS on standing lateral x-rays. Univariate and multivariate analyses were used to investigate patient characteristics and risk factors. Treatment effects (TEs) were calculated and compared between study groups. Results Of 406 patients, 72% underwent instrumented fusion, 21% noninstrumented fusion, and 7% decompression alone. At 8 years, the reoperation rate was 22%, of which 28% occurred within 1 year, 54% within 2 years, 70% within 4 years, and 86% within 6 years. The reasons for reoperation included recurrent stenosis or progressive spondylolisthesis (45%), complications such as hematoma, dehiscence, or infection (36%), or new condition (14%). Reoperative patients were younger (62.2 vs. 65.3, P = 0.008). Significant risk factors were use of antidepressants (P = 0.008, hazard ratio [HR] 2.08) or having no neurogenic claudication upon enrollment (P = 0.02, HR 1.82). Patients who were smokers, diabetics, obese, or on workman's compensation were not at greater risk for reoperation. At 8-year follow-up, scores for SF-36 bodily pain (BP), Oswestry Disability Index, American Academy of Orthopaedic Surgeons/Modems version (ODI), and stenosis frequency index were better in nonreoperative patients. TE favored nonreoperative patients for SF-36 BP, physical function, ODI, Stenosis Bothersomeness Index, and satisfaction with symptoms (P Conclusion The incidence of reoperation for patients with DS was 22% 8 years following surgery. Patients with a history of no neurogenic claudication and patients taking antidepressants were more likely to undergo reoperation. Outcome scores and TE were more favorable in nonreoperative patients. Level of evidence 2.

The objectives of this study were to (1) evaluate differences between patients with lumbar intervertebral disc herniation who received physical therapy (PT) and those who did not; (2) identify factors associated with receiving PT; and (3) examine the influence of PT on clinical outcomes over the course of 1 yr.An observational cohort study using data from the Spine Patient Outcomes Research Trial was conducted. This study included 363 patients with intervertebral disc herniation who received nonsurgical management within 6 wks of enrollment. Baseline characteristics were compared between patients who received PT and those who did not. Multivariate logistic regression examined factors predictive of patients receiving PT. Mixed effects models were used to compare primary outcomes (Short-Form Survey 36 bodily pain and physical function and modified Oswestry Index) at 3 and 6 mos and 1 yr after enrollment.Forty percent of the nonsurgical cohort received PT. Higher disability scores, neurological deficit, and patient preference predicted PT use. Compared with other nonsurgical management strategies, standard care PT was not associated with a significant difference in pain, disability, or surgery over 1 yr.Many patients with intervertebral disc herniation seek secondary care for persisting symptoms and pursue nonsurgical management. The best management strategy is unclear and further research is needed to examine appropriate sequencing and selection of treatment.

STUDY DESIGN A retrospective analysis of prospective, multicenter National Institute of Health clinical trial. OBJECTIVE The aim of this study was to assess the rate of neurologic complications and impact of new neurologic deficits on 1-year postoperative patient-reported outcomes (PROs). SUMMARY OF BACKGROUND DATA There are limited studies evaluating the impact of new neurologic deficits on PROs following surgery for primary presentation adult lumbar scoliosis. METHODS Patients were divided into two groups: new postoperative neurological deficit (Def) or no deficit (NoDef). Preoperative and 1-year follow-up PROs were analyzed [Scoliosis Research Society (SRS) Questionnaire, Oswestry Disability Index (ODI), Short Form-12 Physical/Mental Health Composite Scores (PCS/MCS), and back/leg pain Numerical Rating Scale (NRS)]. RESULTS One hundred forty-one patients: 14 Def (9.9%), 127 NoDef (90.1%). No differences were observed in demographic, radiographic, or PRO data between groups preoperatively. Def group had longer surgical procedures (8.3 vs. 6.9 hours, P = 0.030), greater blood loss (2832 vs. 2606 mL, P = 0.022), and longer hospitalizations (10.6 vs. 7.8 days, P = 0.004). NoDef group reported significant improvement in all PROs from preop to 1-year postoperative. Def group only had improvement in SRS Pain (2.7 preop to 3.4 postop, P = 0.037) and self-image domains (2.7 to 3.6, p = 0.004), and NRS back pain (6.6 to 3.2, P = 0.004) scores with significant worsening of NRS leg pain (4.1 to 6.1, P = 0.045). Group comparisons of 1-year postop PROs found that Def group reported more NRS leg pain (6.1 vs. 1.7, P

BACKGROUND CONTEXT Although short-term adult symptomatic lumbar scoliosis (ASLS) outcomes studies favor operative over nonoperative treatment, long-term outcomes are critical for assessment of treatment durability. PURPOSE To assess whether operative treatment for ASLS provides greater improvement of patient-reported outcomes measures than nonoperative treatment at 5-6-year follow-up. STUDY DESIGN/SETTING Secondary analysis of prospective multicenter cohort. PATIENT SAMPLE Adults with symptomatic lumbar scoliosis enrolled into an NIH-sponsored study to assess outcomes of operative and nonoperative treatments. OUTCOME MEASURES Scoliosis Research Society-22 subscore (SRS-22 subscore), Oswestry Disability Index (ODI), occurrence of related serious adverse events (SAEs) METHODS The ASLS study is an NIH-sponsored multicenter prospective study to assess operative vs nonoperative treatment for ASLS, with randomized and observational treatment arms. Patients were 40-80 years of age with ASLS (Cobb >30° and ODI >20 or SRS-22 subscore (SRS-22) RESULTS The 286 ASLS patients (108 nonoperative, 178 operative) had follow-up rates at 2 and 5-6 years of 90% (256) and 74% (212), respectively. At 5 years, compared with nonoperative, operative patients had greater improvement in SRS-22 subscore (adjusted mean difference, 0.6 [95% CI, 0.5 to 0.6]) and ODI (adjusted mean difference, -14 [95% CI, -18 to -9]) (p CONCLUSIONS The significantly greater clinical improvement of operative vs nonoperative treatment for ASLS at 2 years is maintained at 5-6-year follow-up. Overall, operative patients with a related SAE still had greater improvement than nonoperative patients, but for operative patients with 2+ SAEs, the TEs were markedly reduced. These findings have important implications for patient counseling and cost-effectiveness assessments. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

Background Falls are the leading cause of injuries among older adults, and trips and slips are major contributors to falls. Objective The authors sought to compare the effectiveness of adding a component of surface perturbation training to usual gait/balance training for reducing falls and fall-related injury in high-risk older adults referred to physical therapy. Design This was a multi-center, pragmatic, randomized, comparative effectiveness trial. Setting Treatment took place within 8 outpatient physical therapy clinics. Patients This study included 506 patients 65+ years of age at high fall risk referred for gait/balance training. Intervention This trial evaluated surface perturbation treadmill training integrated into usual multimodal exercise-based balance training at the therapist’s discretion versus usual multimodal exercise-based balance training alone. Measurements Falls and injurious falls were assessed with a prospective daily fall diary, which was reviewed via telephone interview every 3 months for 1 year. A total of 211/253 (83%) patients randomized to perturbation training and 210/253 (83%) randomized to usual treatment provided data at 3-month follow-up. At 3 months, the perturbation training group had a significantly reduced chance of fall-related injury (5.7% versus 13.3%; relative risk 0.43) but no significant reduction in the risk of any fall (28% versus 37%, relative risk 0.78) compared with usual treatment. Time to first injurious fall showed reduced hazard in the first 3 months but no significant reduction when viewed over the entire first year. Limitations The limitations of this trial included lack of blinding and variable application of interventions across patients based on pragmatic study design. Conclusion The addition of some surface perturbation training to usual physical therapy significantly reduced injurious falls up to 3 months posttreatment. Further study is warranted to determine the optimal frequency, dose, progression, and duration of surface perturbation aimed at training postural responses for this population.

STUDY DESIGN Secondary analysis using data from the NIH-sponsored study on adult symptomatic lumbar scoliosis (ASLS) that included randomized and observational arms. OBJECTIVE The aim of this study was to perform an intent-to-treat cost-effectiveness study comparing operative (Op) versus nonoperative (NonOp) care for ASLS. SUMMARY OF BACKGROUND DATA The appropriate treatment approach for ASLS continues to be ill-defined. NonOp care has not been shown to improve outcomes. Surgical treatment has been shown to improve outcomes, but is costly with high revision rates. METHODS Patients with at least 5-year follow-up data were included. Data collected every 3 months included use of NonOp modalities, medications, and employment status. Costs for index and revision surgeries and NonOp modalities were determined using Medicare Allowable rates. Medication costs were determined using the RedBook and indirect costs were calculated based on reported employment status and income. Qualityadjusted life year (QALY) was determined using the SF6D. RESULTS There were 81 of 95 cases in the Op and 81 of 95 in the NonOp group with complete 5-year follow-up data. Not all patients were eligible 5-year follow-up at the time of the analysis. All patients in the Op and 24 (30%) in the NonOp group had surgery by 5 years. At 5 years, the cumulative cost for Op was $96,000 with a QALY gain of 2.44 and for NonOp the cumulative cost was $49,546 with a QALY gain of 0.75 with an incremental cost-effectiveness ratio (ICER) of $27,480 per QALY gain. CONCLUSION In an intent-to-treat analysis, neither treatment was dominant, as the greater gains in QALY in the surgery group come at a greater cost. The ICER for Op compared to NonOp treatment was above the threshold generally considered cost-effective in the first 3 years of the study but improved over time and was highly cost-effective at 4 and 5 years. LEVEL OF EVIDENCE 2.

How to best manage sciatica is not a simple question to answer. Ramaswami, et al . presented the case of Mr. Winston, a 50-year-old patient with low back pain radiating into his L leg with positive nerve root tension signs and a left-sided L4–L5 herniated disk (1). In managing Mr. Winston’s sciatica, Dr. Ramaswami poses two options: to have surgery or to not have surgery.

Study design Prospective, cross-sectional study. Objective The aim of the study was to determine which radiographic parameters drive patient-reported outcomes (PROs) in primary presentation adult symptomatic lumbar scoliosis (ASLS). Summary of background data Previous literature suggests correlations between PROs and sagittal plane deformity (sagittal vertical axis [SVA], pelvic incidence-lumbar lordosis [PI-LL] mismatch, pelvic tilt [PT]). Prior work included revision and primary adult spinal deformity patients. The present study addresses only primary presentation ASLS. Methods Prospective baseline data were analyzed on 286 patients enrolled in an NIH RO1 clinical trial by nine centers from 2010 to 2014. Inclusion criteria 40 to 80 years old, lumbar Cobb (LC) 30° or higher and Scoliosis Research Society-23 score 4.0 or less in Pain, Function or Self-Image domains, or Oswestry Disability Index (ODI) 20 or higher. Patients were primary presentation (no prior spinal deformity surgery) and had complete baseline data: standing coronal/sagittal 36" radiographs and PROs (ODI, Scoliosis Research Society-23, Short Form-12). Correlation coefficients were calculated to evaluate relations between radiographic parameters and PROs for the study population and a subset of patients with ODI 40 or higher. Analysis of variance was used to identify differences in PROs for radiographic modifier groups. Results Mean age was 60.3 years. Mean spinopelvic parameters were: LL = -39.2°; SVA = 3.1 cm; sacral slope = 32.5°; PT = 23.9°; PI-LL mismatch = 16.8°. Only weak correlations (0.2-0.4) were identified between population sacral slope, SVA and SVA modifiers, and SRS function. SVA and SVA modifiers were weakly associated with ODI. Although there were more correlations in subset analysis of high-symptom patients, all were weak. Analysis of variance identified significant differences in ODI reported by SVA modifier groups. Conclusion In primary presentation patients with ASLS and a subset of "high-symptom" patients (ODI ≥ 40), only weak associations between baseline PROs and radiographic parameters were identified. For this patient population, these results suggest regional radiographic parameters (LC, LL, PT, PI-LL mismatch) are not drivers of PROs and cannot be used to extrapolate effect on patient-perceived pathology. Level of evidence 2.

STUDY DESIGN Delphi. OBJECTIVE The aim of this study was to obtain an expert consensus on which history factors are most important in the clinical diagnosis of lumbar spinal stenosis (LSS). SUMMARY OF BACKGROUND DATA LSS is a poorly defined clinical syndrome. Criteria for defining LSS are needed and should be informed by the experience of expert clinicians. METHODS Phase 1 (Delphi Items): 20 members of the International Taskforce on the Diagnosis and Management of LSS confirmed a list of 14 history items. An online survey was developed that permits specialists to express the logical order in which they consider the items, and the level of certainty ascertained from the questions. Phase 2 (Delphi Study) Round 1: Survey distributed to members of the International Society for the Study of the Lumbar Spine. Round 2: Meeting of 9 members of Taskforce where consensus was reached on a final list of 10 items. Round 3: Final survey was distributed internationally. Phase 3: Final Taskforce consensus meeting. RESULTS A total of 279 clinicians from 29 different countries, with a mean of 19 (±SD: 12) years in practice participated. The six top items were "leg or buttock pain while walking," "flex forward to relieve symptoms," "feel relief when using a shopping cart or bicycle," "motor or sensory disturbance while walking," "normal and symmetric foot pulses," "lower extremity weakness," and "low back pain." Significant change in certainty ceased after six questions at 80% (P

Study design An analysis of the State Inpatient Database of North Carolina, 2005 to 2012, and the Nationwide Inpatient Sample, including all inpatient lumbar fusion admissions from nonfederal hospitals. Objective The aim of the study was to examine the influence of a major commercial policy change that restricted lumbar fusion for certain indications and to forecast the potential impact if the policy were adopted nationally. Summary of background data Few studies have examined the effects of recent changes in commercial coverage policies that restrict the use of lumbar fusion. Methods We included adults undergoing elective lumbar fusion or re-fusion operations in North Carolina. We aggregated data into a monthly time series to report changes in the rates and volume of lumbar fusion operations for disc herniation or degeneration, spinal stenosis, spondylolisthesis, or revision fusions. Time series regression models were used to test for significant changes in the use of fusion operation following a major commercial coverage policy change initiated on January 1, 2011. Results There was a substantial decline in the use of lumbar fusion for disc herniation or degeneration following the policy change on January 1, 2011. Overall rates of elective lumbar fusion operations in North Carolina (per 100,000 residents) increased from 103.2 in 2005 to 120.4 in 2009, before declining to 101.9 by 2012. The population rate (per 100,000 residents) of fusion among those under age 65 increased from 89.5 in 2005 to 101.2 in 2009, followed by a sharp decline to 76.8 by 2012. There was no acceleration in the already increasing rate of fusion for spinal stenosis, spondylolisthesis, or revision procedures, but there was a coincident increase in decompression without fusion. Conclusion This commercial insurance policy change had its intended effect of reducing fusion operations for indications with less evidence of effectiveness without changing rates for other indications or resulting in an overall reduction in spine surgery. Nevertheless, broader adoption of the policy could significantly reduce the national rates of fusion operations and associated costs. Level of evidence 3.

Study design A retrospective subgroup analysis was performed on surgically treated patients from the lumbar spinal stenosis (SpS) arm of the Spine Patient Outcomes Research Trial (SPORT), randomized, and observational cohorts. Objective To identify risk factors for reoperation in patients treated surgically for SpS and compare outcomes between patients who underwent reoperation with those who did not. Summary of background data SpS is one of the most common indications for surgery in the elderly; however, few long-term studies have identified risk factors for reoperation. Methods A post-hoc subgroup analysis was performed on patients from the SpS arm of the SPORT, randomized and observational cohorts. Baseline characteristics were analyzed between reoperation and no-reoperation groups using univariate and multivariate analysis on data 8 years postoperation. Results Of the 417 study patients, 88% underwent decompression only, 5% noninstrumented fusion, and 6% instrumented fusion. At the 8-year follow-up, the reoperation rate was 18%; 52% of reoperations were for recurrent stenosis or progressive spondylolisthesis, 25% for complication or other reason, and 16% for new condition. Of patients who underwent a reoperation, 42% did so within 2 years, 70% within 4 years, and 84% within 6 years. Patients who underwent reoperation were less likely to have presented with any neurological deficit (43% reop vs. 57% no reop, P = 0.04). Patients improved less at follow-up in the reoperation group (P Conclusion In patients undergoing surgical treatment for SpS, the reoperation rate at 8-year follow-up was 18%. Patients with a reoperation were less likely to have a baseline neurological deficit. Patients who did not undergo reoperation had better patient reported outcomes at 8-year follow-up compared with those who had repeat surgery. Level of evidence 2.

Background Total hip arthroplasty (THA) relieves pain and improves physical function in patients with hip osteoarthritis, but requires a year or more for full postoperative recovery. Proponents of intermuscular surgical approaches believe that the direct-anterior approach may restore physical function more quickly than transgluteal approaches, perhaps because of diminished muscle trauma. To evaluate this, we compared patient-reported physical function and other outcome metrics during the first year after surgery between groups of patients who underwent primary THA either through the direct-anterior approach or posterior approach.

STUDY DESIGN A prospective, randomized study on patients with lumbar spinal stenosis who received a decision support intervention to facilitate their treatment choice. OBJECTIVE The aim of this study was to assess the impact of telephone health coaching (HC) in addition to a video decision aid (DA) compared with a DA alone for patients with spinal stenosis. SUMMARY OF BACKGROUND DATA Treatment options for lumbar spinal stenosis include surgical and nonsurgical approaches. Patient DAs and HC have been shown to help patients make an informed treatment choice consistent with personal preferences. METHODS Eligible patients with spinal stenosis were identified by an orthopedic surgeon or a nonsurgical spine specialist. Consenting participants were randomly assigned to either a video DA or a video DA along with HC (DA + HC). Patients completed baseline and follow-up questionnaires at 2 weeks, and 6 months after the decision support intervention(s). RESULTS Ninety-eight patients were randomized to the DA + HC group and 101 to the DA-only group; 168 of 199 (84%) patients completed responses at all time points. Both groups showed improved understanding of spinal stenosis treatments and progress in decision making after watching the DA (P

BACKGROUND CONTEXT 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. PURPOSE The purpose of this study is to report on the cost-effectiveness of surgical vs nonsurgical treatment for adult symptomatic lumbar scoliosis (ASLS) using the as-treated data and provide a comparison to previously reported intent-to-treat (ITT) analysis. STUDY DESIGN/SETTING Secondary analysis of data from the NIH sponsored study on ASLS that included randomized and observational arms. PATIENT SAMPLE Patients enrolled in the NIH sponsored study on ASLS that included randomized and observational cohorts with at least five-year follow-up data within the same treatment arm. OUTCOME MEASURES Quality Adjusted Life Years (QALY) derived from the SF-6D. METHODS Patients with at least five-year follow-up data within the same treatment arm were included. Data collected every three months included use of nonoperative modalities, medications and employment status. Costs for surgeries and nonoperative modalities were determined using Medicare allowable rates. Medication costs were determined using the RedBook and indirect costs were calculated based on reported employment status and income. Quality Adjusted Life Years (QALY) was determined using the SF-6D. RESULTS Of 286 patients, 195 patients (73 Nonop, 122 Op) met inclusion criteria. At five 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 2.29. The cumulative cost for the Non-Op group was $29,124 with a cumulative QALY gain of 0.41. This results in an ICER of $44,033 in favor of Op treatment. CONCLUSIONS This as-treated cost effectiveness analysis demonstrates that surgical treatment for adult lumbar scoliosis becomes favorable at year-three, one year earlier than suggested by a previous intent-to-treat analysis. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

PURPOSE: Federally Qualified Health Centers (FQHCs), which were expanded under the Affordable Care Act, are federally funded health centers that aim to improve access to primary care in underserved areas. With continued federal support, the number of FQHCs in the U.S. has increased >80% within a decade. However, the expansion patterns and their impact on the population served are unknown. METHODS: A pre (2007)-post (2014) study of FQHC locations. FQHC locations were identified from the Provider of Services Files then linked to primary care service areas (PCSAs), which represent the service markets that FQHCs served. Road-based travel time was estimated from each 2007 FQHC to the nearest new FQHC as an indicator of geographic expansion in access. PCSA-level characteristics were used to compare 2007 and 2014 FQHC service markets. FINDINGS: Between 2007 and 2014, there was greater expansion in the number of FQHCs (3,489 vs. 6,376; 82.7%) than in the number of service markets (1,835 vs. 2,695; 46.9%). Nearly half of 2007 FQHCs (47%) had at least one new FQHC within 30 minutes travel time. Most newly certified FQHCs (81%) were located in urban areas. Compared to 2007 service markets, the new 2014 markets (N=174) were much less likely to be in areas with >20% of the population below poverty (31.4% vs. 14.9%, P < .001). CONCLUSIONS: The latest expansion of FQHCs were less likely in rural or high poverty areas, suggesting the impact of expansion may have limitations in improving access to care among the most financially disadvantaged populations.

BACKGROUND CONTEXT Although epidural steroid injection (ESI) has been shown to provide adequate pain relief for degenerative spondylolisthesis patients in treatment regimens up to months, it remains unclear whether the use of ESI affects the rate of crossover from nonoperative to operative management. PURPOSE Investigate the relationship between epidural steroid injections and rates of surgical crossover for degenerative spondylolisthesis patients. STUDY DESIGN/SETTING Retrospective review of prospectively collected data from 13 spine centers. PATIENT SAMPLE Degenerative spondylolisthesis patients from both the randomized and concurrent observational cohorts of the Spine Patient Outcomes Research Trial (SPORT). OUTCOME MEASURES Primary: Surgical crossover rates. Secondary: health related quality of life outcome (HRQL) measures (SF-36, ODI, Sciatica and Leg Pain Bothersomeness Indices), self-reported improvement METHODS Included: surgical candidates >18yrs with degenerative spondylolisthesis. Excluded: patients receiving ESI before enrollment. Those who received ESI within 3 months of enrollment (ESI) and those who did not (no-ESI) were compared for differences in baseline characteristics. Outcomes at 1-year, 2-year, 3-year, and 4-year intervals following enrollment were assessed within operative and nonoperative groups using longitudinal mixed–effect models with random subject intercept term to account for correlations between repeated measurements. Treatment comparisons were performed at follow-up intervals. Area under the curve analysis for all time points assessed global significance of treatment. RESULTS Included: 266 patients (192 no-ESI, 74 ESI). Patient groups did not differ in age, sex, BMI, or comorbidity burden (all p>0.05). No-ESI had greater baseline SF-36 body-pain scores (38±20 vs 30±16, p=0.002) and self-reported surgical preference (38% vs 11%, p 0.05). Surgical ESI and no-ESI patients showed no differences in postoperative HRQL changes at any follow-up interval, or in 4-year average HRQL outcomes. Non-operative no-ESI patients showed greater 4-year average improvement in SF-36 body pain (no-ESI: 17.8, ESI: 7.8, p=0.004) and physical function (no-ESI: 13.1, ESI: 4.3, p=0.005) than non-operative ESI patients. These improvements in SF-36 body pain were greater for non-operative no-ESI patients at 1-year (p=0.002) and 3-years (p=0.005); improvements in SF-36 physical function were greater for non-operative no-ESI patients at 1-year (p=0.030) and 2-years (p=0.002). Of patients that were initially non-operative, there was no difference between ESI and no-ESI groups in surgical crossover rates (ESI: 52%, no-ESI: 39%, p=0.15). For operative patients, crossover rates to non-operative treatment did not differ between ESI and no-ESI groups (ESI: 23%, no-ESI: 16%, p=0.38). CONCLUSIONS For surgical degenerative spondylolisthesis patients, there was no relationship between ESI and improved clinical outcomes over a 4-year study. For nonoperative patients, ESI was associated with inferior pain reduction through 3 years of follow-up; however, this was confounded by higher levels of baseline pain. ESI showed little relationship with surgical crossover. FDA DEVICE/DRUG STATUS Unavailable from authors at time of publication.

Objective Patients who use complementary and integrative health services like chiropractic manipulative treatment (CMT) often have different characteristics than do patients who do not, and these differences can confound attempts to compare outcomes across treatment groups, particularly in observational studies when selection bias may occur. The purposes of this study were to provide an overview on how propensity scoring methods can be used to address selection bias by balancing treatment groups on key variables and to use Medicare data to compare different methods for doing so. Methods We described 2 propensity score methods (matching and weighting). Then we used Medicare data from 2006 to 2012 on older, multiply comorbid patients who had a chronic low back pain episode to demonstrate the impact of applying methods on the balance of demographics of patients between 2 treatment groups (those who received only CMT and those who received no CMT during their episodes). Results Before application of propensity score methods, patients who used only CMT had different characteristics from those who did not. Propensity score matching diminished observed differences across the treatment groups at the expense of reduced sample size. However, propensity score weighting achieved balance in patient characteristics between the groups and allowed us to keep the entire sample. Conclusions Although propensity score matching and weighting have similar effects in terms of balancing covariates, weighting has the advantage of maintaining sample size, preserving external validity, and generalizing more naturally to comparisons of 3 or more treatment groups. Researchers should carefully consider which propensity score method to use, as using different methods can generate different results.

Background: Lumbar discectomy and laminectomy in patients with intervertebral disc herniation (IDH) is common, with variable reported reoperation rates. Our study examined which baseline characteristics might be risk factors for reoperation and compared outcomes between patients who underwent reoperation and those who did not. Methods: We performed a retrospective subgroup analysis of patients from the IDH arm of the Spine Patient Outcomes Research Trial (SPORT) randomized and observational cohorts. We analyzed baseline characteristics and outcomes of patients who underwent reoperation and those who did not with use of data collected from enrollment through eight-years of follow-up after surgery. Follow-up times were measured from the time of surgery, and baseline covariates were updated to the follow-up immediately preceding the time of surgery for outcomes analyses. Results: At eight years, the reoperation rate was 15% (691 no reoperation; 119 reoperation). Sixty-two percent of these patients underwent reoperation because of a recurrent disc herniation; 25%, because of a complication or other factor; and 11%, because of a new condition. The proportion of reoperations that were performed for a recurrent disc herniation ranged from 58% to 62% in the individual years. Older patients were less likely to have reoperation (p = 0.015), as were patients presenting with asymmetric motor weakness at baseline (p = 0.0003). Smoking, diabetes, obesity, Workers’ Compensation, and clinical depression were not associated with a greater risk of reoperation. Scores on the Short Form (SF)-36 for bodily pain and physical functioning, the Oswestry Disability Index (ODI), and the Sciatica Bothersomeness Index as well as satisfaction with symptoms had improved less at the time of follow-up in the reoperation group (p < 0.001). Conclusions: In patients who underwent surgery for IDH, the overall reoperation rate was 15% at the eight-year follow-up. Patients of older age and patients presenting with asymmetric motor weakness were less likely to undergo a reoperation. Less improvement in patient-reported outcomes was noted in the reoperation group. Level of Evidence: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

COMMENTARY ON: van den Akker-van Marle ME, Moojen WA, Arts MP, Vleggeert-Lankamp CLAM, Peul WC, for the Leiden-The Hague Spine Intervention Prognostic Study Group (SIPS). Interspinous process devices versus standard conventional surgical decompression for lumbar spinal stenosis: cost-utility analysis. Spine J 2016:16:702–10 ( in this issue ).

Concurrent prospective randomized and observational cohort studies.To assess the 8-year outcomes of surgery versus nonoperative care.Although randomized trials have demonstrated small short-term differences in favor of surgery, long-term outcomes comparing surgical with nonoperative treatment remain controversial.Surgical candidates with imaging-confirmed lumbar intervertebral disc herniation meeting Spine Patient Outcomes Research Trial eligibility criteria enrolled into prospective randomized (501 participants) and observational cohorts (743 participants) at 13 spine clinics in 11 US states. Interventions were standard open discectomy versus usual nonoperative care. Main outcome measures were changes from baseline in the SF-36 Bodily Pain and Physical Function scales and the modified Oswestry Disability Index-AAOS/Modems version assessed at 6 weeks, 3 months, and 6 months, and annually thereafter.Advantages were seen for surgery in intent-to-treat analyses for the randomized cohort for all primary and secondary outcomes other than work status; however, with extensive nonadherence to treatment assignment (49% patients assigned to nonoperative therapy receiving surgery versus 60% of patients assigned to surgery) these observed effects were relatively small and not statistically significant for primary outcomes (bodily pain, physical function, Oswestry Disability Index). Importantly, the overall comparison of secondary outcomes was significantly greater with surgery in the intent-to-treat analysis (sciatica bothersomeness [P0.005], satisfaction with symptoms [P0.013], and self-rated improvement [P0.013]) in long-term follow-up. An as-treated analysis showed significant surgical treatment effects for primary outcome measures (mean change, surgery vs. nonoperative care; treatment effect; 95% confidence interval): bodily pain (45.3 vs. 34.4; 10.9; 7.7 to 14); PF (42.2 vs. 31.5; 10.6; 7.7 to 13.5); and Oswestry Disability Index (-36.2 vs. -24.8; -11.3; -13.6 to -9.1).Carefully selected patients who underwent surgery for a lumbar disc herniation achieved greater improvement than nonoperatively treated patients; there was little to no degradation of outcomes in either group (operative and nonoperative) from 4 to 8 years.2.

Study Design. Retrospective analysis of Medicare claims linked to hospital participation in the Center for Medicare and Medicaid Innovation's episode-based Bundled Payment for Care Improvement (BPCI) program for lumbar fusion. Objective. To describe the early effects of BPCI participation for lumbar fusion on 90-day reimbursement, procedure volume, reoperation, and readmission. Summary of Background Data. Initiated on January 1, 2013, BPCI's voluntary bundle payment program provides a predetermined payment for services related to a Diagnosis-Related Group-defined “triggering event” over a defined time period. As an alternative to fee-for-service, these reforms shift the financial risk of care on to hospitals. Methods. We identified fee-for-service beneficiaries over age 65 undergoing a lumbar fusion in 2012 or 2013, corresponding to the years before and after BPCI initiation. Hospitals were grouped based on program participation status as nonparticipants, preparatory, or risk-bearing. Generalized estimating equation models adjusting for patient age, sex, race, comorbidity, and hospital size were used to compare changes in episode costs, procedure volume, and safety indicators based on hospital BPCI participation. Results. We included 89,605 beneficiaries undergoing lumbar fusion, including 36% seen by a preparatory hospital and 7% from a risk-bearing hospital. The mean age of the cohort was 73.4 years, with 59% women, 92% White, and 22% with a Charlson Comorbidity Index of 2 or more. Participant hospitals had greater procedure volume, bed size, and total discharges. Relative to nonparticipants, risk-bearing hospitals had a slightly increased fusion procedure volume from 2012 to 2013 (3.4% increase vs. 1.6% decrease, P = 0.119), did not reduce 90-day episode of care costs (0.4% decrease vs. 2.9% decrease, P = 0.044), increased 90-day readmission rate (+2.7% vs. −10.7%, P = 0.043), and increased repeat surgery rates (+30.6% vs. +7.1% points, P = 0.043). Conclusion. These early, unintended trends suggest an imperative for continued monitoring of BPCI in lumbar fusion. Conclusion. Level of Evidence: 3

Study Design. Secondary analysis of data from a concurrent randomized trial and cohort study. Objective. The aim of this study was to determine risks and predictors of recurrent pain following standard open discectomy for subacute/chronic symptomatic lumbar disc herniation (SLDH). Summary of Background Data. Most previous studies of recurrence after discectomy do not explicitly define pain resolution and recurrence, and do not account for variable durations of time at risk for recurrence. Methods. We used survival analysis methods to examine predictors of leg pain recurrence. For individuals with initial resolution of leg pain, we defined recurrent leg pain as having leg pain, receiving lumbar epidural steroid injections, or undergoing lumbar surgery subsequent to initial leg pain resolution. We calculated cumulative risks of leg pain recurrence using Kaplan-Meier survival curves, and examined predictors of recurrence using Cox proportional hazards models. We used similar methods to examine LBP recurrence. Results. One- and three-year cumulative risks of leg pain recurrence were 20% and 45%, respectively. One- and three- year leg pain recurrence risks were substantially lower in participants with complete initial resolution of leg pain (17% and 41%, respectively) than in those without (27% and 54%, respectively). In multivariate analyses, complete leg pain resolution (adjusted hazard ratio [aHR] 0.69; 95% confidence interval [CI] 0.52–0.90), smoking (aHR 1.68 [95% CI 1.22–2.33]), and depression (aHR 1.74 [95% CI 1.18–2.56]) predicted leg pain recurrence. The 1- and 3-year risk of LBP recurrence was 29% and 65%, respectively. LBP recurrence risk at 3 years was substantially lower in participants with complete initial resolution of LBP than in those without, but not at 1 year. Conclusion. Recurrence of leg pain and LBP is common after discectomy for SLDH. Cumulative risks of both leg pain and LBP recurrence were generally lower in participants achieving complete initial resolution of pain post-discectomy. Conclusion. Level of Evidence: 2

STUDY DESIGN Spine Patient Outcomes Research Trial subgroup analysis. OBJECTIVE To evaluate the effect of high obesity on management of lumbar spinal stenosis, degenerative spondylolisthesis (DS), and intervertebral disc herniation (IDH). SUMMARY OF BACKGROUND DATA Prior Spine Patient Outcomes Research Trial analyses compared nonobese and obese patients. This study compares nonobese patients (body mass index