Association between chiropractic care and use of prescription opioids among older medicare beneficiaries with spinal pain: a retrospective observational study.

BACKGROUND: The burden of spinal pain can be aggravated by the hazards of opioid analgesics, which are still widely prescribed for spinal pain despite evidence-based clinical guidelines that identify non-pharmacological therapies as the preferred first-line approach. Previous studies have found that chiropractic care is associated with decreased use of opioids, but have not focused on older Medicare beneficiaries, a vulnerable population with high rates of co-morbidity and polypharmacy. The purpose of this investigation was to evaluate the association between chiropractic utilization and use of prescription opioids among older adults with spinal pain. METHODS: We conducted a retrospective observational study in which we examined a nationally representative multi-year sample of Medicare claims data, 2012-2016. The study sample included 55,949 Medicare beneficiaries diagnosed with spinal pain, of whom 9,356 were recipients of chiropractic care and 46,593 were non-recipients. We measured the adjusted risk of filling a prescription for an opioid analgesic for up to 365 days following diagnosis of spinal pain. Using Cox proportional hazards modeling and inverse weighted propensity scoring to account for selection bias, we compared recipients of both primary care and chiropractic to recipients of primary care alone regarding the risk of filling a prescription. RESULTS: The adjusted risk of filling an opioid prescription within 365 days of initial visit was 56% lower among recipients of chiropractic care as compared to non-recipients (hazard ratio 0.44; 95% confidence interval 0.40-0.49). CONCLUSIONS: Among older Medicare beneficiaries with spinal pain, use of chiropractic care is associated with significantly lower risk of filling an opioid prescription.

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.

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.

Spinal Manipulation vs Prescription Drug Therapy for Chronic Low Back Pain: Beliefs, Satisfaction With Care, and Qualify of Life Among Older Medicare Beneficiaries.

OBJECTIVE: The objective of this study was to compare patients' perspectives on the use of spinal manipulative therapy (SMT) compared to prescription drug therapy (PDT) with regard to health-related quality of life (HRQoL), patient beliefs, and satisfaction with treatment. METHODS: Four cohorts of Medicare beneficiaries were assembled according to previous treatment received as evidenced in claims data: SMT, PDT, and 2 crossover cohorts (where participants experienced both types of treatments). A total of 195 Medicare beneficiaries responded to the survey. Outcome measures used were a 0-to-10 numeric rating scale to measure satisfaction, the Low Back Pain Treatment Beliefs Questionnaire to measure patient beliefs, and the 12-item Short Form Health Survey to measure HRQoL. RESULTS: Recipients of SMT were more likely to be very satisfied with their care (84%) than recipients of PDT (50%; P = .002). The SMT cohort self-reported significantly higher HRQoL compared to the PDT cohort; mean differences in physical and mental health scores on the 12-item Short Form Health Survey were 12.85 and 9.92, respectively. The SMT cohort had a lower degree of concern regarding chiropractic care for their back pain compared to the PDT cohort's reported concern about PDT (P = .03). CONCLUSION: Among older Medicare beneficiaries with chronic low back pain, long-term recipients of SMT had higher self-reported rates of HRQoL and greater satisfaction with their modality of care than long-term recipients of PDT. Participants who had longer-term management of care were more likely to have positive attitudes and beliefs toward the mode of care they received.

Occurrence and Management of Thrombocytopenia in Metastatic Colorectal Cancer Patients Receiving Chemotherapy: Secondary Analysis of Data From Prospective Clinical Trials.

INTRODUCTION: Chemotherapy-induced thrombocytopenia (CIT) contributes to treatment dose delay and/or modification, often resulting in poorer survival and disease progression. We explored the incidence and clinical consequences of CIT among metastatic colorectal cancer (mCRC) patients. MATERIALS AND METHODS: Data from two prospective randomized phase 3 trials of mCRC patients receiving either first-line FOLFOX4 (fluorouracil, leucovorin, oxaliplatin) or second-line FOLFIRI (fluorouracil, leucovorin, irinotecan) were analyzed. Thrombocytopenia was defined by platelet count < 100 × 109/L (further categorized by grade) and by recorded adverse events (AEs). Co-occurrence of anemia (hemoglobin < 12 g/dL) and neutropenia (neutrophil count < 2 × 109/L) and clinical consequences of CIT were also evaluated. RESULTS: Among 1078 mCRC patients in the FOLFOX4 study, cumulative incidence of CIT based on platelet count was 37% (grade 3, 2%; grade 4, 1%) during an average 8 months' follow-up. Neutropenia or anemia were absent in 44% of CIT episodes; 62% of CIT AEs led to chemotherapy dose delay, change, and/or discontinuation. Among 1067 mCRC patients in the FOLFIRI study, cumulative incidence of CIT based on platelet count was 4% (grade 3, < 1%; grade 4, 0) during an average 4 months' follow-up. Neutropenia or anemia were absent in 22% of CIT episodes; 32% of CIT AEs led to chemotherapy dose delay, change, and/or discontinuation. With both regimens, transfusions and hospitalizations after CIT AEs were rare (< 3%). CONCLUSION: CIT was common among mCRC patients receiving the FOLFOX4 regimen. The most frequent consequence of CIT was a delay in chemotherapy, highlighting the unmet need in CIT management.

Implementation of the Primary Spine Care Model in a Multi-Clinician Primary Care Setting: An Observational Cohort Study.

OBJECTIVE: The objective of this investigation was to compare the value of primary spine care (PSC) with usual care for management of patients with spine-related disorders (SRDs) within a primary care setting. METHODS: We retrospectively examined existing patient encounter data at 3 primary care sites within a multi-clinic health system. Designated clinicians serve in the role as PSC as the initial point of contact for spine patients, coordinate, and follow up for the duration of the episode of care. A PSC may be a chiropractor, physical therapist, or medical or osteopathic physician who has been trained to provide primary care for patients with SRDs. The PSC model of care had been introduced at site I (Lebanon, New Hampshire); sites II (Bedford, New Hampshire) and III (Nashua, New Hampshire) served as control sites where patients received usual care. To evaluate cost outcomes, we employed a controlled quasi-experimental design for analysis of health claims data. For analysis of clinical outcomes, we compared clinical records for PSC at site I and usual care at sites II and III, all with reference to usual care at site I. We examined clinical encounters occurring over a 24-month period, from February 1, 2016 through January 31, 2018. RESULTS: Primary spine care was associated with reduced total expenditures compared with usual care for SRDs. At site I, average per-patient expenditure was $162 in year 1 and $186 in year 2, compared with site II ($332 in year 1; $306 in year 2) and site III ($467 in year 1; $323 in year 2). CONCLUSION: Among patients with SRDs included in this study, implementation of the PSC model within a conventional primary care setting was associated with a trend toward reduced total expenditures for spine care compared with usual primary care. Implementation of PSC may lead to reduced costs and resource utilization, but may be no more effective than usual care regarding clinical outcomes.

Impact of Chiropractic Care on Use of Prescription Opioids in Patients with Spinal Pain.

OBJECTIVE: Utilization of nonpharmacological pain management may prevent unnecessary use of opioids. Our objective was to evaluate the impact of chiropractic utilization upon use of prescription opioids among patients with spinal pain. DESIGN AND SETTING: We employed a retrospective cohort design for analysis of health claims data from three contiguous states for the years 2012-2017. SUBJECTS: We included adults aged 18-84 years enrolled in a health plan and with office visits to a primary care physician or chiropractor for spinal pain. We identified two cohorts of subjects: Recipients received both primary care and chiropractic care, and nonrecipients received primary care but not chiropractic care. METHODS: We performed adjusted time-to-event analyses to compare recipients and nonrecipients with regard to the risk of filling an opioid prescription. We stratified the recipient populations as: acute (first chiropractic encounter within 30 days of diagnosis) and nonacute (all other patients). RESULTS: The total number of subjects was 101,221. Overall, between 1.55 and 2.03 times more nonrecipients filled an opioid prescription, as compared with recipients (in Connecticut: hazard ratio [HR] = 1.55, 95% confidence interval [CI] = 1.11-2.17, P = 0.010; in New Hampshire: HR = 2.03, 95% CI = 1.92-2.14, P < 0.0001). Similar differences were observed for the acute groups. CONCLUSIONS: Patients with spinal pain who saw a chiropractor had half the risk of filling an opioid prescription. Among those who saw a chiropractor within 30 days of diagnosis, the reduction in risk was greater as compared with those with their first visit after the acute phase.

Association Between Utilization of Chiropractic Services for Treatment of Low Back Pain and Risk of Adverse Drug Events.

OBJECTIVES: Mortality rates due to adverse drug events (ADEs) are escalating in the United States. Analgesics are among the drug classes most often associated with occurrence of an ADE. Utilization of nonpharmacologic chiropractic services for treatment of low back pain could lead to reduced risk of an ADE. The objective of this investigation was to evaluate the association between utilization of chiropractic services and likelihood of an ADE. METHODS: We employed a retrospective cohort design to analyze health insurance claims data from the state of New Hampshire. After inversely weighting each participant by their propensity to be in their cohort, we employed logistic regression to compare recipients of chiropractic services to nonrecipients with regard to likelihood of occurrence of an ADE in an outpatient setting. RESULTS: The risk of an ADE was significantly lower among recipients of chiropractic services as compared with nonrecipients. The adjusted likelihood of an ADE occurring in an outpatient setting within 12 months was 51% lower among recipients of chiropractic services as compared to nonrecipients (OR 0.49; P = .0002). The reported ADEs were nonspecific with regard to drug category in the majority of incidents that occurred in both cohorts. CONCLUSIONS: Among New Hampshire adults with office visits for low back pain, the adjusted likelihood of an ADE was significantly lower for recipients of chiropractic services as compared to nonrecipients. No causal relationship was established between utilization of chiropractic care and risk of an ADE. Future research should employ larger databases, rigorous methods to reduce risk of bias, and more sensitive means of identifying ADEs.

Association Between Utilization of Chiropractic Services for Treatment of Low-Back Pain and Use of Prescription Opioids.

OBJECTIVE: Pain relief resulting from services delivered by doctors of chiropractic may allow patients to use lower or less frequent doses of opioids, leading to reduced risk of adverse effects. The objective of this investigation was to evaluate the association between utilization of chiropractic services and the use of prescription opioid medications. DESIGN: The authors used a retrospective cohort design to analyze health insurance claims data. SETTING: The data source was the all payer claims database administered by the State of New Hampshire. The authors chose New Hampshire because health claims data were readily available for research, and in 2015, New Hampshire had the second-highest age-adjusted rate of drug overdose deaths in the United States. SUBJECTS: The study population comprised New Hampshire residents aged 18-99 years, enrolled in a health plan, and with at least two clinical office visits within 90 days for a primary diagnosis of low-back pain. The authors excluded subjects with a diagnosis of cancer. OUTCOME MEASURES: The authors measured likelihood of opioid prescription fill among recipients of services delivered by doctors of chiropractic compared with nonrecipients. They also compared the cohorts with regard to rates of prescription fills for opioids and associated charges. RESULTS: The adjusted likelihood of filling a prescription for an opioid analgesic was 55% lower among recipients compared with nonrecipients (odds ratio 0.45; 95% confidence interval 0.40-0.47; p < 0.0001). Average charges per person for opioid prescriptions were also significantly lower among recipients. CONCLUSIONS: Among New Hampshire adults with office visits for noncancer low-back pain, the likelihood of filling a prescription for an opioid analgesic was significantly lower for recipients of services delivered by doctors of chiropractic compared with nonrecipients. The underlying cause of this correlation remains unknown, indicating the need for further investigation.

Robotic sacrocolpopexy for the management of pelvic organ prolapse: a review of midterm surgical and quality of life outcomes.

INTRODUCTION: Transabdominal sacrocolpopexy is a definitive treatment option for vaginal vault prolapse with durable success rates. The aim of our study was to review subjective and objective outcomes including complications after robotic assisted laparoscopic sacrocolpopexy for the repair of symptomatic pelvic organ prolapse. METHODS: Single-site retrospective cohort study of women undergoing robotic assisted laparoscopic sacrocolpopexy with and without concomitant robotic assisted supracervical hysterectomy was performed. Pelvic Floor Distress Inventory-20 and Pelvic Floor Impact Questionnaire-7 questionnaires were used preoperatively and postoperatively to evaluate patient subjective data, respectively. We established a strict improvement of greater than 70% on questionnaire's total score to determine clinical improvement. RESULTS: Complications were assessed at 6 months and 127 women were included in our review. Mesh extrusion occurred in 3 (2.4%) patients. Other complications reported were bowel injury (2.4%), readmission rate (2.4%), wound infection (1.6%), and postoperative hernia at port site (1.6%). Objective and subjective outcomes were assessed at 1 year in 92 women. Although there was no recurrent apical prolapse at 1 year, anterior prolapse was present in 7 patients. Clinical improvement was present in 72% by Pelvic Floor Impact Questionnaire-7 and in 68% by Pelvic Floor Distress Inventory-20. Predictors of poor clinical outcomes were lysis of adhesions (OR, 5.83; 95% confidence interval [CI], 1.2-27.4; P = 0.026), urethrolysis (OR, 11.91; 95% CI, 1.2-117.9; P = 0.034), current smoking (OR, 7.9; 95% CI, 1.1-58.7; P = 0.042), and older age (OR, 1.1; 95% CI, 1.0-1.18; P = 0.044). CONCLUSIONS: Robotic assisted laparoscopic sacrocolpopexy represents a safe and effective surgical therapy to manage symptomatic apical pelvic organ prolapse. Serious complication rates are low but not rare when assessing short-term outcomes.

Medicare's demonstration of expanded coverage for chiropractic services: limitations of the demonstration and an alternative direct cost estimate.

OBJECTIVE: The purposes of this study were to examine the direct costs associated with Medicare's 2005-2007 "Demonstration of Expanded Coverage of Chiropractic Services" (Demonstration) and their drivers, to explore practice pattern variation during the Demonstration, and to describe scenarios of cost implications had provider behavior and benefit coverage been different. METHODS: Using Medicare Part B data from April 1, 2005, and March 31, 2007, and 2004 Rural Urban Continuum Codes, we conducted a retrospective analysis of traditionally reimbursed and expanded chiropractic services provided to patients aged 65 to 99 years who had a neuromusculoskeletal condition. We compared chiropractic care costs, supply, and utilization patterns for the 2-year periods before, during, and after the Demonstration for 5 Chicago area counties that participated in the Demonstration to those for 6 other county aggregations-urban or rural counties that participated in the Demonstration; were designated comparison counties during the Demonstration; or were neither participating nor comparison counties during the Demonstration. RESULTS: When compared with other groups, doctors of chiropractic in 1 region (Chicago area counties) billed more aggressively for expanded services and were reimbursed significantly more for traditionally reimbursed chiropractic services provided before, during, and after the Demonstration. Costs would have been substantially lower had doctors of chiropractic in this 1 region had responded similarly to those in other demonstration counties. CONCLUSION: We found widespread geographic variation in practice behavior and patterns. Our findings suggest that Medicare might reduce the risk of accelerated costs associated with the introduction of a new benefit by applying appropriate limits to the frequency of use and overall costs of those benefits, particularly in highly competitive markets.

Anti-inflammatory effect of aprotinin: a meta-analysis.

It is important to define the extent, and any limitations, of potential anti-inflammatory regimens used in cardiac surgery to guide the rational combination of drugs to suppress the systemic inflammatory response. Aprotinin (Trasylol) is an anti-fibrinolytic agent with reported anti-inflammatory properties. In this study, we investigated the published data on aprotinin's effect on acute phase protein and cytokine levels in cardiac surgery patients. Randomized placebo-controlled trials of aprotinin published between 1985 and 2007, in adult cardiac surgery using cardiopulmonary bypass, reporting tumor necrosis factor-alpha (TNF-alpha), interleukin-6 (IL-6), IL-8, and IL-10 levels were included for review. Two independent reviewers graded each paper and collected information on inflammatory markers. RevMan 4.3 statistical software was used to calculate and plot the weighted mean difference between placebo and aprotinin groups. Thirteen studies met the review criteria. None of the inflammatory markers were reduced by high-dose aprotinin treatment. Low-dose aprotinin significantly reduced IL-10 levels after protamine administration (-41.3 pg/ mL; 95% CI: -59.5, -23.1), but this result was gone by the first post-operative day. These meta-analyses showed no significant effect of aprotinin on acute phase proteins or systemic cytokine markers of inflammation during clinical adult cardiac surgery using cardiopulmonary bypass. While recognizing that other host defense systems, such as coagulation and complement, contribute to the overall systemic inflammatory response, the evidence presented here does not support the clinical use of aprotinin as an anti-inflammatory agent on its own.