Long-term effectiveness of epidural steroid injections after new episodes of low back pain in older adults.

BACKGROUND: There is limited research on the long-term effectiveness of epidural steroid injections (ESI) in older adults despite the high prevalence of back and leg pain in this age group. We tested the hypotheses that older adults undergoing ESI, compared to patients not receiving ESI: (1) have worse pain, disability and quality of life ('outcomes') pre-ESI, (2) have improved outcomes after ESI and (3) have improved outcomes due to a specific ESI effect. METHODS: We prospectively studied patients ≥65 years old presenting to primary care with new episodes of back pain in three US healthcare systems (BOLD registry). Outcomes were leg and back pain intensity, disability and quality of life, assessed at baseline and 3-, 6-, 12- and 24-month follow-ups. We categorized participants as: (1) ESI within 6 months from the index visit (n = 295); (2) no ESI within 6 months (n = 4809); (3) no ESI within 6 months, propensity-score matched to group 1 (n = 483). We analysed the data using linear regression and Generalized Estimating Equations. RESULTS: Pain intensity, disability and quality of life at baseline were significantly worse at baseline in ESI patients (group 1) than in group 2. The improvement from baseline to 24 months in all outcomes was statistically significant for group 1. However, no statistically significant differences were observed between outcome trajectories for the propensity-score matched groups 1 and 3. CONCLUSIONS: Older adults treated with ESI have long-term improvement. However, the improvement is unlikely the result of a specific ESI effect. SIGNIFICANCE: In this large, two-year, prospective study in older adults with a new episode of low back pain, back pain, leg pain, disability and quality of life improved after epidural steroid injections; however, propensity-score matching revealed that the improvement was unlikely the result of a specific effect of the injections, indicating that epidural steroids are unlikely to provide long-term benefits in older adults with new episodes of back and leg pain.

Providing Epidemiological Data in Lumbar Spine Imaging Reports Did Not Affect Subsequent Utilization of Spine Procedures: Secondary Outcomes from a Stepped-Wedge Randomized Controlled Trial.

OBJECTIVE: To evaluate the effect of inserting epidemiological information into lumbar spine imaging reports on subsequent nonsurgical and surgical procedures involving the thoracolumbosacral spine and sacroiliac joints. DESIGN: Analysis of secondary outcomes from the Lumbar Imaging with Reporting of Epidemiology (LIRE) pragmatic stepped-wedge randomized trial. SETTING: Primary care clinics within four integrated health care systems in the United States. SUBJECTS: 238,886 patients ≥18 years of age who received lumbar diagnostic imaging between 2013 and 2016. METHODS: Clinics were randomized to receive text containing age- and modality-specific epidemiological benchmarks indicating the prevalence of common spine imaging findings in people without low back pain, inserted into lumbar spine imaging reports (the "LIRE intervention"). The study outcomes were receiving 1) any nonsurgical lumbosacral or sacroiliac spine procedure (lumbosacral epidural steroid injection, facet joint injection, or facet joint radiofrequency ablation; or sacroiliac joint injection) or 2) any surgical procedure involving the lumbar, sacral, or thoracic spine (decompression surgery or spinal fusion or other spine surgery). RESULTS: The LIRE intervention was not significantly associated with subsequent utilization of nonsurgical lumbosacral or sacroiliac spine procedures (odds ratio [OR] = 1.01, 95% confidence interval [CI] 0.93-1.09; P = 0.79) or any surgical procedure (OR = 0.99, 95 CI 0.91-1.07; P = 0.74) involving the lumbar, sacral, or thoracic spine. The intervention was also not significantly associated with any individual spine procedure. CONCLUSIONS: Inserting epidemiological text into spine imaging reports had no effect on nonsurgical or surgical procedure utilization among patients receiving lumbar diagnostic imaging.

Effects of Including Epidemiologic Data in Lumbar Spine Imaging Reports on Prescribing Non-Opioid Medications for Pain.

BACKGROUND: Information on the prevalence of common imaging findings among patients without back pain in spine imaging reports might affect pain medication prescribing for patients with back pain. Prior research on inserting this text suggested a small reduction in opioid prescribing. OBJECTIVE: To evaluate the effect of epidemiologic information in spine imaging reports on non-opioid pain medication prescribing for primary care patients with back pain. DESIGN: Post hoc analysis of the Lumbar Imaging with Reporting of Epidemiology cluster-randomized trial. PARTICIPANTS: A total of 170,680 patients aged ≥ 18 years from four healthcare systems who received thoracolumbar, lumbar, or lumbosacral spine imaging from 2013 to 2016 and had not received a prescription for non-opioid pain medication in the preceding 120 days. INTERVENTION: Text of age- and modality-specific epidemiologic benchmarks indicating the prevalence of common findings in people without back pain inserted into thoracolumbar, lumbar, or lumbosacral spine imaging reports at intervention clinics. MAIN MEASURES: Primary outcomes: any non-opioid prescription within 90 days after index imaging, overall, and by sub-class (skeletal muscle relaxants, NSAIDs, gabapentinoids, tricyclic antidepressants, benzodiazepines, duloxetine). SECONDARY OUTCOMES: count of non-opioid prescriptions within 90 days, overall, and by sub-class. KEY RESULTS: The intervention was not associated with the likelihood of patients receiving at least one prescription for new non-opioid pain-related medications, overall (adjusted OR, 1.02; 95% CI, 0.97-1.08) or by sub-class. The intervention was not associated with the number of prescriptions for any non-opioid medication (adjusted incidence rate ratio [IRR], 1.02; 95% CI, 0.99-1.04). However, the intervention was associated with more new prescriptions for NSAIDs (IRR, 1.12) and tricyclic antidepressants (IRR, 1.11). CONCLUSIONS: Inserting epidemiologic text in spine imaging reports had no effect on whether new non-opioid pain-related medications were prescribed but was associated with the number of new prescriptions for certain non-opioid sub-classes. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02015455.

Prospective Investigation of Factors Associated with Prescription Opioid Dose Escalation among Patients in Integrated Health Systems.

BACKGROUND: Prior research has identified factors associated with prescription opioid initiation, but little is known about the prevalence or predictors of dose escalation among patients already prescribed long-term opioid therapy (LTOT). OBJECTIVE: This was a 2-year prospective cohort study to examine patient and clinician factors associated with opioid dose escalation. DESIGN: A prospective cohort study. Participants were seen at baseline and every 6 months for a total of 2 years. PARTICIPANTS: Patients prescribed a stable dose of LTOT for musculoskeletal pain were recruited from two integrated health systems (Kaiser Permanente and the Department of Veterans Affairs, respectively). MAIN MEASURES: The prescription opioid dose was based on pharmacy records and self-report. Administrative data were gathered on characteristics of the opioid-prescribing clinician and healthcare utilization. Participants completed measures of pain, functioning, and quality of life. KEY RESULTS: Of enrolled participants (n = 517), 19.5% had an opioid dose increase. In multivariate analyses, patient variables associated with dose escalation were lower opioid dose (hazard ratio [HR] = 0.86, 95% confidence interval [CI] = 0.79-0.94, for every 10-mg increase in baseline dose) and greater pain catastrophizing (HR = 1.03, 95% CI = 1.01-1.05). Other variables associated with dose escalation were as follows: receiving medications from a nurse practitioner primary care provider (HR = 2.10, 95% CI = 1.12-3.96) or specialty physician (HR = 3.18, 95% CI = 1.22-8.34), relative to a physician primary care provider, and having undergone surgery within the past 6 months (HR = 1.80, 95% CI = 1.10-2.94). Other variables, including pain intensity, pain disability, or depression, were not associated with dose escalation. CONCLUSIONS: In this 2-year prospective cohort study, variables associated with opioid dose escalation were lower opioid dose, higher pain catastrophizing, receiving opioids from a medical specialist (rather than primary care clinician) or nurse practitioner, and having recently undergone surgery. Study findings highlight intervention points that may be helpful for reducing the likelihood of future prescription opioid dose escalation.

Time to Align Coverage with Evidence for Treatment of Back Pain.

Despite improved knowledge about the benefits and harms of treatments for chronic back pain in the past several decades, there is a large and consequential mismatch between treatments found safe and effective and those routinely covered by health insurance. As a result, care for back pain has, if anything, deteriorated in recent decades-expenses are higher, harms are greater, and use of ineffective treatments is more common. Deficiencies in health care delivery processes and payment models are centrally involved in the failure to improve care for back pain. A key step for accelerating progress is changing insurance coverage policies to facilitate use of the safest and most helpful approaches while discouraging riskier and less effective treatments. Relatively simple changes in reimbursement policies may minimize harm and improve quality of life for many patients with chronic back and similar pain syndromes. Such changes might also reduce health care expenditures because the costs of treatments currently covered by insurance and their associated harms may well outweigh the costs of the relatively safe and effective treatments recommended by current guidelines but poorly covered by insurance. There is no justification for continuing the status quo-patients and clinicians deserve better.

Use of prescription opioids before and after an operation for chronic pain (lumbar fusion surgery).

Lumbar fusion surgery is usually prompted by chronic back pain, and many patients receive long-term preoperative opioid analgesics. Many expect surgery to eliminate the need for opioids. We sought to determine what fraction of long-term preoperative opioid users discontinue or reduce dosage postoperatively; what fraction of patients with little preoperative use initiate long-term use; and what predicts long-term postoperative use. This retrospective cohort study included 2491 adults undergoing lumbar fusion surgery for degenerative conditions, using Oregon's prescription drug monitoring program to quantify opioid use before and after hospitalization. We defined long-term postoperative use as ≥4 prescriptions filled in the 7 months after hospitalization, with at least 3 occurring >30 days after hospitalization. Overall, 1045 patients received long-term opioids preoperatively, and 1094 postoperatively. Among long-term preoperative users, 77.1% continued long-term postoperative use, and 13.8% had episodic use. Only 9.1% discontinued or had short-term postoperative use. Among preoperative users, 34.4% received a lower dose postoperatively, but 44.8% received a higher long-term dose. Among patients with no preoperative opioids, 12.8% became long-term users. In multivariable models, the strongest predictor of long-term postoperative use was cumulative preoperative opioid dose (odds ratio of 15.47 [95% confidence interval 8.53-28.06] in the highest quartile). Cumulative dose and number of opioid prescribers in the 30-day postoperative period were also associated with long-term use. Thus, lumbar fusion surgery infrequently eliminated long-term opioid use. Opioid-naive patients had a substantial risk of initiating long-term use. Patients should have realistic expectations regarding opioid use after lumbar fusion surgery.

Understanding the value of minimally invasive procedures for the treatment of lumbar spinal stenosis: the case of interspinous spacer devices.

BACKGROUND CONTEXT: Minimally invasive lumbar spinal stenosis procedures have uncertain long-term value. PURPOSE: This study sought to characterize factors affecting the long-term cost-effectiveness of such procedures using interspinous spacer devices ("spacers") relative to decompression surgery as a case study. STUDY DESIGN: Model-based cost-effectiveness analysis. PATIENT SAMPLE: The Medicare Provider Analysis and Review database for the years 2005-2009 was used to model a group of 65-year-old patients with spinal stenosis who had no previous spine surgery and no contraindications to decompression surgery. OUTCOME MEASURES: Costs, quality-adjusted life years (QALYs), and cost per QALY gained were the outcome measures. METHODS: A Markov model tracked health utility and costs over 10 years for a 65-year-old cohort under three care strategies: conservative care, spacer surgery, and decompression surgery. Incremental cost-effectiveness ratios (ICER) reported as cost per QALY gained included direct medical costsfor surgery. Medicare claims data were used to estimate complication rates, reoperation, and related costs within 3 years. Utilities and long-term reoperation rates for decompression were derived frompublished studies. Spacer failure requiring reoperation beyond 3 years and post-spacer health utilities are uncertain and were evaluated through sensitivity analyses. In the base-case, the spacer failure rate was held constant for years 4-10 (cumulative failure: 47%). In a "worst-case" analysis, the 10-year cumulative reoperation rate was increased steeply (to 90%). Threshold analyses were performed to determine the impact of failure and post-spacer health utility on the cost-effectiveness of spacer surgery. RESULTS: The spacer strategy had an ICER of $89,500/QALY gained under base-case assumptions, and remained under $100,000 as long as the 10-year cumulative probability of reoperation did not exceed 54%. Under worst-case assumptions, the spacer ICER was $482,000/QALY and fell below $100,000 only if post-spacer utility was 0.01 greater than post-decompression utility or the cost of spacer surgery was $1,600 less than the cost of decompression surgery. CONCLUSIONS: Spacers may provide a reasonably cost-effective initial treatment option for patients with lumbar spinal stenosis. Their value is expected to improve if procedure costs are lower in outpatient settings where these procedures are increasingly being performed. Decision analysis is useful for characterizing the long-term cost-effectiveness potential for minimally invasive spinal stenosis treatments and highlights the importance of complication rates and prospective health utility assessment.

Trends, Complications, and Costs for Hospital Admission and Surgery for Lumbar Spinal Stenosis.

MINI: Trends in lumbar spinal stenosis surgery are largely unknown outside of the United States. This population-based health record linkage study revealed that complex fusion surgery had a four-fold increase from 2003-2013 in Australia. This surgical procedure increased the risk of complications and resource use compared with decompression surgery alone. STUDY DESIGN: Population-based health record linkage study. OBJECTIVE: The aim of this study was to determine trends in hospital admissions and surgery for lumbar spinal stenosis, as well as complications and resource use in Australia. SUMMARY OF BACKGROUND DATA: In the United States, rates of decompression surgery have declined, whereas those of fusion have increased. It is unclear whether this trend is also happening elsewhere. METHODS: We included patients 18 years and older admitted to a hospital in New South Wales between 2003 and 2013 who were diagnosed with lumbar spinal stenosis. We investigated the rates of hospital admission and surgical procedures, as well as hospital costs, length of hospital stay, and complications. Surgical procedures were: decompression alone, simple fusion (one to two disc levels, single approach), and complex fusion (three or more disc levels or a combined posterior and anterior approach). RESULTS: The rates of decompression alone increased from 19.0 to 22.1 per 100,000 people. Simple fusion rates increased from 1.3 to 2.8 per 100,000 people, whereas complex fusion increased from 0.6 to 2.4 per 100,000 people. The odds of major complications for complex fusion compared with decompression alone was 4.1 (95% confidence interval [CI]: 1.7-10.1), although no significant difference was found for simple fusion (odds ratio 2.0, 95% CI: 0.7-6.1). Mean hospital costs with decompression surgery were AU $12,168, whereas simple and complex fusion cost AU $30,811 and AU $32,350, respectively. CONCLUSION: In Australia, decompression rates for lumbar spinal stenosis increased from 2003 to 2013. The fastest increasing surgical procedure was complex fusion. This procedure increased the risk of major complications and resource, although recent evidence suggest fusion provides no additional benefits to the traditional decompression surgery. LEVEL OF EVIDENCE: 3.

Long-Term Effects of Repeated Injections of Local Anesthetic With or Without Corticosteroid for Lumbar Spinal Stenosis: A Randomized Trial.

OBJECTIVE: To determine the overall long-term effectiveness of treatment with epidural corticosteroid injections for lumbar central spinal stenosis and the effect of repeat injections, including crossover injections, on outcomes through 12 months. DESIGN: Multicenter, double-blind, randomized controlled trial comparing epidural injections of corticosteroid plus lidocaine versus lidocaine alone. SETTING: Sixteen clinical sites. PARTICIPANTS: Participants with imaging-confirmed lumbar central spinal stenosis (N=400). INTERVENTIONS: Participants were randomized to receive either epidural injections with corticosteroid plus lidocaine or lidocaine alone with the option of blinded crossover after 6 weeks to receive the alternate treatment. Participants could receive 1 to 2 injections from 0 to 6 weeks and up to 2 injections from 6 to 12 weeks. After 12 weeks, participants received usual care. MAIN OUTCOME MEASURES: Primary outcomes were the Roland-Morris Disability Questionnaire (RDQ) (range, 0-24, where higher scores indicate greater disability) and leg pain intensity (range, 0 [no pain] to 10 [pain as bad as you can imagine]). Secondary outcomes included opioid use, spine surgery, and crossover rates. RESULTS: At 12 months, both treatment groups maintained initial observed improvements, with no significant differences between groups on the RDQ (adjusted mean difference, -0.4; 95% confidence interval [CI], -1.6 to 0.9; P=.55), leg pain (adjusted mean difference, 0.1; 95% CI, -0.5 to 0.7; P=.75), opioid use (corticosteroid plus lidocaine: 41.4% vs lidocaine alone: 36.3%; P=.41), or spine surgery (corticosteroid plus lidocaine: 16.8% vs lidocaine alone: 11.8%; P=.22). Fewer participants randomized to corticosteroid plus lidocaine (30%, n=60) versus lidocaine alone (45%, n=90) crossed over after 6 weeks (P=.003). Among participants who crossed over at 6 weeks, the 6- to 12-week RDQ change did not differ between the 2 randomized treatment groups (adjusted mean difference, -1.0; 95% CI, -2.6 to 0.7; P=.24). In both groups, participants crossing over at 6 weeks had worse 12-month trajectories compared with participants who did not choose to crossover. CONCLUSIONS: For lumbar spinal stenosis symptoms, epidural injections of corticosteroid plus lidocaine offered no benefits from 6 weeks to 12 months beyond that of injections of lidocaine alone in terms of self-reported pain and function or reduction in use of opioids and spine surgery. In patients with improved pain and function 6 weeks after initial injection, these outcomes were maintained at 12 months. However, the trajectories of pain and function outcomes after 3 weeks did not differ by injectate type. Repeated injections of either type offered no additional long-term benefit if injections in the first 6 weeks did not improve pain.

Clinicians' Use of Prescription Drug Monitoring Programs in Clinical Practice and Decision-Making.

Objectives: Little is known about clinicians' use of prescription drug monitoring program (PDMP) profiles in decision-making. The objective of this qualitative study was to understand how clinicians use, interpret, and integrate PDMP profiles with other information in making clinical decisions. Design: Qualitative interviews of clinician PDMP users. Setting: Oregon registrants in the state's PDMP. Subjects: Thirty-three clinicians practicing in primary care, emergency medicine, pain management, psychiatry, dentistry, and surgery. Methods: We conducted semistructured telephone interviews with PDMP users. A multidisciplinary team used a grounded theory approach to identify patterns of PDMP use and how PDMP profiles influence clinical decisions. Results: PDMP use varied from consistent monitoring to checking the PDMP only on suspicion of misuse, with inconsistent use reported particularly among short-term prescribers. Primary care clinicians reported less routine use with existing pain patients than with new patients. In response to worrisome PDMP profiles with new patients, participants reported declining to prescribe, except in the case of acute, verifiable conditions. Long-term prescribers reported sometimes continuing prescriptions for existing patients depending on perceived patient intent, honesty, and opioid misuse risk. Some long-term prescribers reported discharging patients from their practices due to worrisome PDMP profiles; others expressed strong ethical grounds for retaining patients but discontinuing controlled substances. Conclusion: Greater consistency is needed in use of PDMP in monitoring existing patients and in conformity to guidelines against discharging patients from practice. Research is needed to determine optimal approaches to interpreting PDMP profiles in relation to clinical judgment, patient screeners, and other information.

Association Between Initial Opioid Prescribing Patterns and Subsequent Long-Term Use Among Opioid-Naïve Patients: A Statewide Retrospective Cohort Study.

BACKGROUND: Long-term efficacy of opioids for non-cancer pain is unproven, but risks argue for cautious prescribing. Few data suggest how long or how much opioid can be prescribed for opioid-naïve patients without inadvertently promoting long-term use. OBJECTIVE: To examine the association between initial opioid prescribing patterns and likelihood of long-term use among opioid-naïve patients. DESIGN: Retrospective cohort study; data from Oregon resident prescriptions linked to death certificates and hospital discharges. PARTICIPANTS: Patients filling opioid prescriptions between October 1, 2012, and September 30, 2013, with no opioid fills for the previous 365 days. Subgroup analyses examined patients under age 45 who did not die in the follow-up year, excluding most cancer or palliative care patients. MAIN MEASURES: Exposure: Numbers of prescription fills and cumulative morphine milligram equivalents (MMEs) dispensed during 30 days following opioid initiation ("initiation month"). OUTCOME: Proportion of patients with six or more opioid fills during the subsequent year ("long-term users"). KEY RESULTS: There were 536,767 opioid-naïve patients who filled an opioid prescription. Of these, 26,785 (5.0 %) became long-term users. Numbers of fills and cumulative MMEs during the initiation month were associated with long-term use. Among patients under age 45 using short-acting opioids who did not die in the follow-up year, the adjusted odds ratio (OR) for long-term use among those receiving two fills versus one was 2.25 (95 % CI: 2.17, 2.33). Compared to those who received < 120 total MMEs, those who received between 400 and 799 had an OR of 2.96 (95 % CI: 2.81, 3.11). Patients initiating with long-acting opioids had a higher risk of long-term use than those initiating with short-acting drugs. CONCLUSIONS: Early opioid prescribing patterns are associated with long-term use. While patient characteristics are important, clinicians have greater control over initial prescribing. Our findings may help minimize the risk of inadvertently initiating long-term opioid use.

Bone Morphogenetic Protein Use and Cancer Risk Among Patients Undergoing Lumbar Arthrodesis: A Case-Cohort Study Using the SEER-Medicare Database.

BACKGROUND: Recombinant bone morphogenetic proteins (BMPs) are growth factors utilized in lumbar arthrodeses. Limited data from randomized trials suggest that BMP may increase cancer risk. We sought to evaluate cancer risk and mortality following the use of BMP in lumbar arthrodesis. METHODS: Within the linked Surveillance, Epidemiology, and End Results (SEER) Program-Medicare cohort, we conducted a case-cohort study of 7,278 individuals who were ≥65 years of age and had undergone a lumbar arthrodesis from 2004 to 2011. Of these patients, 3,627 were individuals in a 5% random subcohort of Medicare enrollees in SEER areas including 191 who developed cancer, and there were 3,651 individuals outside the subcohort who developed cancer. Weighted Cox proportional-hazards regression was used to estimate hazard ratios (HRs) and 95% confidence intervals (95% CIs) for cancer on the basis of exposure to BMP. RESULTS: In the SEER-Medicare subcohort, 30.7% of individuals who underwent a lumbar arthrodesis received BMP. BMP was not associated with overall cancer risk in univariate analyses (HR, 0.92 [95% CI, 0.82 to 1.02]) or after adjustment for demographic characteristics, comorbidities, hospital size, history of cancer, and calendar year (adjusted HR, 0.94 [95% CI, 0.84 to 1.05]). Individual cancer types were also not significantly elevated (p > 0.05 for all) in BMP users compared with nonusers. In addition, BMP use was not associated with a new cancer in people who had cancer prior to undergoing lumbar arthrodesis (adjusted HR, 1.04 [95% CI, 0.71 to 1.52]) or with mortality after a cancer diagnosis (adjusted HR, 1.05 [95% CI, 0.93 to 1.19]). CONCLUSIONS: In a large population of elderly U.S. adults undergoing lumbar arthrodesis, BMP use was not associated with cancer risk or mortality. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Clinical Styles and Practice Policies: Influence on Communication with Patients Regarding Worrisome Prescription Drug Monitoring Program Data.

OBJECTIVES: Clinician communication with patients regarding worrisome findings in Prescription Drug Monitoring Programs (PDMPs) may influence patient responses and subsequent care. The authors studied the range of approaches clinicians report when communicating with patients in this situation and how practice policies and procedures may influence this communication. DESIGN: Qualitative interviews of clinician PDMP users. SETTING: Oregon registrants in the state's PDMP. SUBJECTS: Thirty-three clinicians practicing in pain management, emergency medicine, primary care, psychiatry, dentistry, and surgery. METHODS: The authors conducted semi-structured interviews via telephone with clinicians who routinely used the PDMP. A multidisciplinary team used a grounded theory approach to identify ways clinicians reported using information from the PDMP when communicating with patients, and policies that influenced that communication. RESULTS: Clinicians reported using a range of approaches for communicating about PDMP results, from openly sharing, to questioning patients without disclosing access to the PDMP, to avoiding the conversation. Clinicians also reported practice policies and procedures that influenced communication with their patients about prescribing and ongoing care, including policies that normalized use of the PDMP with all patients and those that facilitated difficult conversations by providing a rationale not to prescribe in certain circumstances. CONCLUSION: Clinicians' self-reported approaches to sharing PDMP findings and communicating prescribing decisions with patients vary and may be facilitated by appropriate practice policies. Such communication may have implications for patient engagement and alliance building. More research is needed to identify best practices and potential guidelines for effectively communicating about PDMP findings, as this may enhance health outcomes.

A Prospective Study of Back Pain and Risk of Falls Among Older Community-dwelling Women.

BACKGROUND: Back pain and falls are common health conditions among older U.S. women. The extent to which back pain is an independent risk factor for falls has not been established. METHODS: We conducted a prospective study among 6,841 community-dwelling U.S. women at least 65 years of age from the Study of Osteoporotic Fractures (SOF). Baseline questionnaires inquired about any back pain, pain severity, and frequency in the past year. During 1 year of follow-up, falls were summed from self-reports obtained every 4 months. Two outcomes were studied: recurrent falls (≥2 falls) and any fall (≥1 fall). Associations of back pain and each fall outcome were estimated with risk ratios (RRs) and 95% confidence intervals (CIs) from multivariable log-binomial regression. Adjustments were made for age, education, smoking status, fainting history, hip pain, stroke history, vertebral fracture, and Geriatric Depression Scale. RESULTS: Most (61%) women reported any back pain. During follow-up, 10% had recurrent falls and 26% fell at least once. Any back pain relative to no back pain was associated with a 50% increased risk of recurrent falls (multivariable RR = 1.5, 95% CI: 1.3, 1.8). Multivariable RRs for recurrent falls were significantly elevated for all back pain symptoms, ranging from 1.4 (95% CI: 1.1, 1.8) for mild back pain to 1.8 (95% CI: 1.4, 2.3) for activity-limiting back pain. RRs of any fall were also significantly increased albeit smaller than those for recurrent falls. CONCLUSIONS: Older community-dwelling women with a recent history of back pain are at increased risk for falls.

Effects of a Commercial Insurance Policy Restriction on Lumbar Fusion in North Carolina and the Implications for National Adoption.

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.

Opioids for low back pain.

Back pain affects most adults, causes disability for some, and is a common reason for seeking healthcare. In the United States, opioid prescription for low back pain has increased, and opioids are now the most commonly prescribed drug class. More than half of regular opioid users report back pain. Rates of opioid prescribing in the US and Canada are two to three times higher than in most European countries. The analgesic efficacy of opioids for acute back pain is inferred from evidence in other acute pain conditions. Opioids do not seem to expedite return to work in injured workers or improve functional outcomes of acute back pain in primary care. For chronic back pain, systematic reviews find scant evidence of efficacy. Randomized controlled trials have high dropout rates, brief duration (four months or less), and highly selected patients. Opioids seem to have short term analgesic efficacy for chronic back pain, but benefits for function are less clear. The magnitude of pain relief across chronic non-cancer pain conditions is about 30%. Given the brevity of randomized controlled trials, the long term effectiveness and safety of opioids are unknown. Loss of long term efficacy could result from drug tolerance and emergence of hyperalgesia. Complications of opioid use include addiction and overdose related mortality, which have risen in parallel with prescription rates. Common short term side effects are constipation, nausea, sedation, and increased risk of falls and fractures. Longer term side effects may include depression and sexual dysfunction. Screening for high risk patients, treatment agreements, and urine testing have not reduced overall rates of opioid prescribing, misuse, or overdose. Newer strategies for reducing risks include more selective prescription of opioids and lower doses; use of prescription monitoring programs; avoidance of co-prescription with sedative hypnotics; and reformulations that make drugs more difficult to snort, smoke, or inject.

Fusion surgery for lumbar degenerative disc disease: still more questions than answers.

COMMENTARY ON: Yoshihara H, Yoneoka D. National trends in the surgical treatment for lumbar degenerative disc disease: United States, 2000 to 2009. Spine J 2015;15:265-71 (in this issue).

Use of bone morphogenetic protein among patients undergoing fusion for degenerative diagnoses in the United States, 2002 to 2012.

BACKGROUND CONTEXT: Use of bone morphogenetic protein (BMP) as an adjunct to spinal fusion surgery proliferated after Food and Drug Administration (FDA) approval in 2002. Major safety concerns emerged in 2008. PURPOSE: The purpose of this study was to examine whether published concerns about the safety of BMP altered clinical practice. STUDY DESIGN/SETTING: The study design involved the analysis of the National Inpatient Sample from 2002 through 2012. PATIENT SAMPLE: Adults (older than 20 years) undergoing an elective fusion operation for common degenerative diagnoses were identified using codes from the International Classification of Diseases, ninth revision, Clinical Modification. OUTCOME MEASURES: Outcome measures were proportion of cervical and lumbar fusion operations, over time, that involved BMP. METHODS: We aggregated the data into a monthly time series and reported the proportion of cervical and lumbar fusion operations, over time, that involved BMP. Autoregressive Integrated Moving Average, a regression model for time series data, was used to test whether there was a statistically significant change in the overall rate of BMP use after an FDA Public Health Notification in 2008. RESULTS: Use of BMP in spinal fusion procedures increased rapidly until 2008, involving up to 45.2% of lumbar and 13.5% of cervical fusions. Bone morphogenetic protein use significantly decreased after the 2008 FDA Public Health Notification and revelations of financial payments to surgeons involved in the pivotal FDA-approved trials. For lumbar fusion, the average annual increase was 7.9 percentage points per year from 2002 to 2008, followed by an average annual decrease of 11.7 percentage points thereafter (p≤.001). Use of BMP in cervical fusion increased 2.0% per year until the FDA Public Health Notification, followed by a 2.8% per year decrease (p=.035). CONCLUSIONS: Use of BMP in spinal fusion surgery declined subsequent to published safety concerns and revelations of financial conflicts of interest for investigators involved in the pivotal clinical trials.

Long-term outcomes after in-hospital CPR in older adults with chronic illness.

BACKGROUND: Outcomes after in-hospital CPR in older adults with chronic illness are unclear. METHODS: We examined inpatient Medicare data from 1994 through 2005 to identify CPR recipients. We grouped beneficiaries aged ≥ 67 years by severity of six chronic diseases-COPD, congestive heart failure (CHF), chronic kidney disease (CKD), malignancy, diabetes, and cirrhosis-and investigated survival to discharge, discharge destination, rehospitalizations, and long-term survival. RESULTS: We identified 358,682 CPR recipients. Most patients with chronic disease were less likely to survive to discharge (eg, 14.8% in the advanced COPD group [P < .001] and 11.3% in the advanced malignancy group [P < .001]) than patients without chronic illness (17.3%). Among discharge survivors, the median long-term survival was shorter in patients with chronic illness (eg, 5.0, 3.5, and 2.8 months in the advanced COPD, malignancy, and cirrhosis groups, respectively; P < .001 for all) than without (26.7 months). Although 7.2% of CPR recipients without chronic disease were discharged home and survived at least 6 months without readmission, ≤ 2.0% of recipients with advanced COPD, CHF, malignancy, and cirrhosis (P < .001 for all) met these criteria. Adjusted analyses confirmed that most subgroups with chronic illness had lower hospital discharge survival, and among discharge survivors, most were discharged home less often, experienced more hospital readmissions, and had worse long-term survival. CONCLUSIONS: Older CPR recipients with any of the six underlying chronic diseases investigated generally have much worse outcomes than CPR recipients without chronic disease. These findings may substantially affect decisions about CPR in patients with chronic illness.