A cross-sectional survey exploring clinician perceptions of a novel Medicaid back pain policy.

OBJECTIVES: Oregon Medicaid (Oregon Health Plan, or OHP) implemented an innovative policy in 2016 that increased coverage of evidence-based non-pharmacologic therapies (NPT, including physical therapy, massage, chiropractic, and acupuncture) while restricting opioids, epidural steroid injections, and surgeries. The objective of this study was to compare the perspectives of clinicians who see back pain patients and can prescribe pharmacologic therapies and/or refer to NPTs and clinicians who directly provide NPT therapies affected by the policy. METHODS: A cross-sectional online survey was administered to Oregon prescribing clinicians and NPT clinicians between December 2019 and February 2020. The survey was completed by 107 prescribing clinicians and 83 NPT clinicians. RESULTS: Prescribing clinicians and NPT clinicians had only moderate levels of familiarity with core elements of the policy. Prescribing clinicians had higher levels of frustration caring for OHP patients with back pain than NPT clinicians (83 vs. 34%, p<0.001) and were less confident in their ability to provide effective care (73 vs. 85%, p = .025). Eighty-six percent of prescribing clinicians and 83% of NPT clinicians thought active NPT treatments were effective; 74 and 70% thought passive NPT treatments were effective. Forty percent of prescribing clinicians and 25% of NPT clinicians (p<0.001) thought medically-light therapies were effective, while 29% of prescribing clinicians and 10% of NPT clinicians thought medically-intensive treatments were effective (p=0.001). Prescribing clinicians thought increased access to NPTs improved outcomes, while opinions were less consistent on the impact of restricting opioid prescribing. CONCLUSIONS: Prescribing clinicians and NPT clinicians had varying perspectives of a Medicaid coverage policy to increase evidence-based back pain care. Understanding these perspectives is important for contextualizing policy effectiveness.

Reduction of Long-Term Opioid Prescribing for Back Pain in Community Health Centers After a Medicaid Policy Change.

INTRODUCTION: Beginning around 2011, innumerable policies have aimed to improve pain treatment while minimizing harms from excessive use of opioids. It is not known whether changing insurance coverage for specific conditions is an effective strategy. We describe and assess the effect of an innovative Oregon Medicaid back/neck pain coverage policy on opioid prescribing patterns. METHODS: This retrospective cohort study uses electronic health record data from a network of community health centers (CHCs) in Oregon to analyze prescription opioid dose changes among patients on long-term opioid treatment (LOT) affected by the policy. RESULTS: Of the 1,789 patients on LOT at baseline, 41.6% had an average daily dose of <20 morphine milligram equivalents (MME), 32.3% had ≥20 to <50 MME, 14.5% had ≥50 to <90 MME, and 11.6% ≥90 MME. Around half of each group discontinued opioids within the 18-month policy period. Those who discontinued did so gradually (average of 11 months) regardless of starting dosage. Predictors of discontinuation included: diagnosis of opioid use disorder, older, non-Hispanic white, and less medical complexity. CONCLUSIONS: Regardless of starting opioid dose, nearly half of patients affected by the 2016 Oregon Medicaid back/neck pain treatment policy no longer received opioid prescriptions by the end of the 18-month study period; another 30% decreased their dose. Gradual dose reduction was typical. These outcomes suggest that the policy impacted opioid prescribing. Understanding patient experiences resulting from such policies could help clinicians and policy makers navigate the complex balance between potential harms and benefits of LOT.

[Tapentadol versus classical WHO-III opioids for chronic back pain. Health services research study based on representative data from health insurance funds]. / Tapentadol versus klassische WHO-III-Opioide bei chronischen Rückenschmerzen : Versorgungsforschungsstudie auf Basis repräsentativer Krankenkassendaten.

BACKGROUND/OBJECTIVE: In clinical trials, tapentadol prolonged release (PR) showed a more favourable gastrointestinal tolerability profile compared to other strong opioids in the treatment of pain. The present analysis compared tapentadol PR and classical WHO-III PR opioids in routine clinical practice. METHOD: Retrospective cohort study (matched pair approach) using anonymised health insurance data of patients with chronic low back pain who were prescribed strong opioids following pretreatment with WHO-I/II analgesics. Data were analysed from the date of first prescription in 2015 over a maximum period of two years. The primary analysis parameter was the prescription of laxatives. RESULTS: Data of 227 patients per cohort could be included in the analysis. Significantly fewer tapentadol PR than WHO-III PR patients were prescribed laxatives (20.3% vs. 37%; p < 0.0001). In addition, laxative dosages were significantly lower in the tapentadol PR cohort (26.4 vs. 82.5 defined daily doses; p < 0.0001). A significant difference in laxative prescription was also observed under long-term treatment (tapentadol PR patients 27.7% vs. WHO-III PR patients 50%; p = 0.0029). CONCLUSION: Routine clinical practice indirectly confirmed the more favourable gastrointestinal tolerability of tapentadol PR in the treatment of chronic pain which had previously been demonstrated in clinical trials and non-interventional studies.

Experiences of Nonpharmacologic Providers Implementing the Oregon Back Pain Policy Expanding Services for Medicaid Recipients: A Focus Group Study.

Introduction: The objective of this study was to understand the experiences of nonpharmacologic therapy (NPT) providers implementing the Oregon Back Pain Policy (OBPP). The Medicaid OBPP expanded coverage of evidence-based NPTs for back pain and simultaneously restricted access to acute and chronic opioid therapy and some interventional approaches for chronic back pain. Materials and Methods: This study uses a cross-sectional, observational design. The authors conducted three online focus groups with 44 credentialed NPT providers in February 2020. Qualitative data analysis was conducted by a multidisciplinary team with an immersion/crystallization approach. Results: Four themes emerged from the data. Participants reported: (1) a lack of direct communication about the policy and mixed levels of understanding of the policy, (2) belief that expanding access to NPT and restricting opioids was beneficial for patients, (3) implementation challenges that compromised access and the perceived effectiveness of care, and (4) financial challenges in accepting Medicaid referrals, due to reimbursement and administrative burden. Conclusion: The goal of the OBPP was to increase access to evidence-based back pain care, including new coverage of NPT services and decreased opioid prescribing for back pain. This study revealed that although many NPT providers support the goals of this policy, the policy was not communicated systematically to providers and was hampered by implementation challenges.

Predicting postoperative opioid use with machine learning and insurance claims in opioid-naïve patients.

BACKGROUND: The clinical impact of postoperative opioid use requires accurate prediction strategies to identify at-risk patients. We utilize preoperative claims data to predict postoperative opioid refill and new persistent use in opioid-naïve patients. METHODS: A retrospective study was conducted on 112,898 opioid-naïve adult postoperative patients from Optum's de-identified Clinformatics® Data Mart database. Potential predictors included sociodemographic data, comorbidities, and prescriptions within one year prior to surgery. RESULTS: Compared to linear models, non-linear models led to modest improvements in predicting refills - area under the receiver operating characteristics curve (AUROC) 0.68 vs. 0.67 (p < 0.05) - and performed identically in predicting new persistent use - AUROC = 0.66. Undergoing major surgery, opioid prescriptions within 30 days prior to surgery, and abdominal pain were useful in predicting refills; back/joint/head pain were the most important features in predicting new persistent use. CONCLUSIONS: Preoperative patient attributes from insurance claims could potentially be useful in guiding prescription practices for opioid-naïve patients.

Trends in Low-Value Health Service Use and Spending in the US Medicare Fee-for-Service Program, 2014-2018.

Importance: Low-value care, defined as care offering no net benefit in specific clinical scenarios, is associated with harmful outcomes in patients and wasteful spending. Despite a national education campaign and increasing attention on reducing health care waste, recent trends in low-value care delivery remain unknown. Objective: To assess national trends in low-value care use and spending. Design, Setting, and Participants: In this cross-sectional study, analyses of low-value care use and spending from 2014 to 2018 were conducted using 100% Medicare fee-for-service enrollment and claims data. Included individuals were aged 65 years or older and continuously enrolled in Medicare parts A, B, and D during each measurement year and the previous year. Data were analyzed from September 2019 through December 2020. Exposure: Being enrolled in fee-for-service Medicare for a period of time, in years. Main Outcomes and Measures: The Milliman MedInsight Health Waste Calculator was used to assess 32 claims-based measures of low-value care associated with Choosing Wisely recommendations and other professional guidelines. The calculator designates services as wasteful, likely wasteful, or not wasteful based on an absence of indication of appropriate use in the claims history; calculator-designated wasteful services were defined as low-value care. Spending was calculated as claim-line level (ie, spending on the low-value service) and claim level (ie, spending on the low-value service plus associated services), adjusting for inflation. Results: Among 21 045 759 individuals with fee-for-service Medicare (mean [SD] age, 77.4 [7.9] years; 12 515 915 [59.5%] women), the percentage receiving any of 32 low-value services decreased from 36.3% (95% CI, 36.3%-36.4%) to 33.6% (95% CI, 33.6%-33.6%) from 2014 to 2018. Uses of low-value services per 1000 individuals decreased from 677.8 (95% CI, 676.2-679.5) to 632.7 (95% CI, 632.6-632.8) from 2014 to 2018. Three services comprised approximately two-thirds of uses among 32 low-value services per 1000 individuals: preoperative laboratory testing decreased from 213.8 (95% CI, 213.4-214.2) to 166.2 (95% CI, 166.2-166.2), while opioids for back pain increased from 154.4 (95% CI, 153.6-155.2) to 182.1 (95% CI, 182.1-182.1) and antibiotics for upper respiratory infections increased from 75.0 (95% CI, 75.0-75.1) to 82 (95% CI, 82.0-82.0). Spending per 1000 individuals on low-value care also decreased, from $52 765.5 (95% CI, $51 952.3-$53 578.6) to $46 921.7 (95% CI, $46 593.7-$47 249.7) at the claim-line level and from $160 070.4 (95% CI, $158 999.8-$161 141.0) to $144 741.1 (95% CI, $144 287.5-$145 194.7) at the claim level. Conclusions and Relevance: This cross-sectional study found that among individuals with fee-for-service Medicare receiving any of 32 measured services, low-value care use and spending decreased marginally from 2014 to 2018, despite a national education campaign in collaboration with clinician specialty societies and increased attention on low-value care. While most use of low-value care came from 3 services, 1 of these was opioid prescriptions, which increased over time despite the harms associated with their use. These findings may represent several opportunities to prevent patient harm and lower spending.

Bone fractures in patients using tapentadol or oxycodone: an exploratory US claims database study.

Aim: To explore fracture outcomes with tapentadol or oxycodone, two opioids with differing mechanisms of action. Materials & methods: Retrospective cohort pilot study, using MarketScan® Commercial and Medicare Supplemental claims databases, on patients with postoperative pain, back pain, or osteoarthritis and ≥1 claim for tapentadol (n = 16,457), oxycodone (n = 1,356,920), or both (n = 15,893) between June 2009 and December 2015. Results: During 266,826 and 9,007,889 days of tapentadol and oxycodone treatment, patients evidenced 1080 and 72,275 fractures, respectively. Fracture rates per treatment-year were 1.512 for tapentadol and 3.013 for oxycodone. Conclusion: Examination of administrative claims has inherent limitations, but this exploratory analysis indicates a lower fracture rate with tapentadol than oxycodone in the analyzed dataset, which needs confirmation by further clinical trials.

The bird's-eye view: A data-driven approach to understanding patient journeys from claims data.

OBJECTIVE: In preference-sensitive conditions such as back pain, there can be high levels of variability in the trajectory of patient care. We sought to develop a methodology that extracts a realistic and comprehensive understanding of the patient journey using medical and pharmaceutical insurance claims data. MATERIALS AND METHODS: We processed a sample of 10 000 patient episodes (comprised of 113 215 back pain-related claims) into strings of characters, where each letter corresponds to a distinct encounter with the healthcare system. We customized the Levenshtein edit distance algorithm to evaluate the level of similarity between each pair of episodes based on both their content (types of events) and ordering (sequence of events). We then used clustering to extract the main variations of the patient journey. RESULTS: The algorithm resulted in 12 comprehensive and clinically distinct patterns (clusters) of patient journeys that represent the main ways patients are diagnosed and treated for back pain. We further characterized demographic and utilization metrics for each cluster and observed clear differentiation between the clusters in terms of both clinical content and patient characteristics. DISCUSSION: Despite being a complex and often noisy data source, administrative claims provide a unique longitudinal overview of patient care across multiple service providers and locations. This methodology leverages claims to capture a data-driven understanding of how patients traverse the healthcare system. CONCLUSIONS: When tailored to various conditions and patient settings, this methodology can provide accurate overviews of patient journeys and facilitate a shift toward high-quality practice patterns.

Evaluation of Cost-Utility of Thoracic Interlaminar Epidural Injections.

PURPOSE OF REVIEW: Chronic thoracic pain, even though not as prevalent as low back and neck pain, appears in approximately 30% of the general population. The severity of thoracic pain and degree of disability seems to be similar to other painful conditions. Despite this severity, interventions in managing chronic thoracic pain are less frequent, and there is a paucity of literature regarding epidural injections and facet joint interventions. RECENT FINDINGS: As with lumbar and cervical spine, a multitude of interventions are offered in managing chronic thoracic pain, including interventional techniques with epidural injections and facet joint interventions. A single randomized controlled trial (RCT) has been published with a 2-year follow-up of clinical effectiveness of the results. However, there have not been any cost-utility analysis studies pertaining to either epidural injections or facet joint interventions in thoracic pain. Based on the results of the RCT, a cost-utility analysis of thoracic interlaminar epidural injections was undertaken. Evaluation of the cost-utility analysis of thoracic interlaminar epidural injections with or without steroids in managing thoracic disc herniation, thoracic spinal stenosis, and thoracic discogenic or axial pain was assessed in 110 patients with a 2-year follow-up. Direct payment data from 2018 was utilized for procedural costs and indirect costs. Costs, including drug costs, were determined by multiplication of direct procedural payment data by a factor of 1.67 or addition of 40% of cost to accommodate for indirect payments and arrive at overall costs. Cost-utility analysis showed direct procedural cost of USD $1943.19, whereas total estimated costs year per QALY were USD $3245.12.

A rare case of Spinal Epidural Abscess following mesotherapy: a challenging diagnosis and the importance of clinical risk management. Considerations concerning uncommon risk factor for development of Spinal Epidural Abscess and its prevention.

Spinal Epidural Abscess (SEA) is a rare pyogenic infection localized between dura mater and vertebral periostium. The development of SEA is associated with the presence of medical co-morbidities and risk factors that facilitate bacterial dissemination. It is possible distinguish two type of SEA: primary SEA due to pathogen hematogenous dissemination and secondary SEA resulting from direct inoculation of pathogen. This entity, very uncommon, shows a prevalence peak between the 5th and the 7th decade of life with predominance in males. The case is a 44 years old Caucasian man with chronic low back pain, treated with physiotherapy and anti-inflammatory drugs. Following an episode of acute severe exacerbation of pain, the patient underwent four session of dorsal and lumbo-sacral area mesotherapy. One month after the last session, the patient experienced acute sever lumbar pain, radiated to left lower limb and accompanied by fever and vomiting. During hospitalization, elevated levels of white blood cells and C Reactive Protein (CRP) were found. Moreover, a vertebral magnetic resonance imaging revealed the presence of intramedullary lesion. Furthermore, methicillin sensitive staphylococcus aureus was isolated from three blood cultures and antibiotic therapy was performed. In our case the patient had the typical SEA onset, without any specific risk factors excepting the execution of four session of mesotherapy. Aim of this study is to explain risk factors for the SEA development and to clarify how act as preventive measure, because also acupuncture can promote bacterial infection.

Medical Use of Long-term Extended-release Opioid Analgesics in Commercially Insured Adults in the United States.

OBJECTIVES: We examined the proportion of patients initiating extended-release (ER) opioids who become long-term users and describe how pain-related diagnoses before initiation of opioid therapy vary between drugs and over time. METHODS: Using MarketScan (2006-2015), a US national commercial insurance database, we examined pain-related diagnoses in the 182-day baseline period before initiation of ER opioid therapy to characterize indications for opioid initiation. We report the proportion who became long-term users, the median length of opioid therapy, and the proportion with cancer and other noncancer chronic pain, by active ingredient. RESULTS: Among 1,077,566 adults initiating ER opioids, 31% became long-term users, with a median length of use of 209 days. The most common ER opioids prescribed were oxycodone (26%) and fentanyl (23%), and the most common noncancer pain diagnoses were back pain (65%) and arthritis (48%). Among all long-term users, 16% had a diagnosis of cancer. We found notable variation by drug. Eighteen percent of patients initiating drugs approved by the Food and Drug Administration >10 years ago had evidence of cancer during baseline compared with only 8% of patients who received newer drugs. CONCLUSIONS: In a national sample of adults with private insurance, back pain was the most common diagnosis preceding initiation of opioid therapy. Opioids that have been approved within the last 10 years were more frequently associated with musculoskeletal pains and less frequently associated with cancer. Amid increasing concerns regarding long-term opioid therapy, our findings provide context regarding the conditions for which long-term opioid therapy is prescribed.

Factors associated with potentially problematic opioid prescriptions among individuals with private insurance and medicaid.

If opioid analgesics are prescribed and used inappropriately, they can lead to addiction and other adverse effects. In this study, we (1) examine factors associated with potentially problematic opioid prescriptions and (2) quantify the link between potentially problematic prescriptions and the development of opioid use disorder. We found that older age; female sex; having back pain, arthritis, or migraine; hydrocodone prescription; previous pharmacotherapy for opioid use disorder; and frequent emergency department use were associated with problematic prescriptions among individuals with Medicaid and private insurance. Patients with commercial insurance and Medicaid who had potentially problematic opioid prescriptions were eight and three times more likely, respectively, to develop an opioid use disorder than patients without potentially problematic opioid prescriptions. Our findings help identify factors associated with problematic prescriptions and underscore the importance of targeted public health interventions.

Sociodemographic inequality in joint-pain medication use among community-dwelling older adults in Israel.

Joint pain is a common experience among adults aged 65 and over. Although pain management is multifaceted, medication is essential in it. The paper examines the use of medication among older adults with joint pain in Israel and asks whether socioeconomic factors are associated with this usage. The data, harvested, from the Survey of Health, Aging and Retirement in Europe (SHARE), include 1,294 randomly selected community-dwelling individuals aged 65 and over in Israel. Bivariate analysis and logistic regression are used to identify factors associated with the presence of joint pain medication use. About 38% of respondents report experiencing joint pain and 45% of those who so report are not taking prescription medication. Back pain is the most common location, reported by 64% of individuals who report joint pain. Taking medication is independently associated with younger age (OR = 0.965, 95% CI = 0.939-0.991), more education (OR = 1.044, 95% CI = 0.998-1.091), and better ability to cope economically (OR = 1.964, 95% CI = 1.314-2.936). However, older age and ability to cope economically are independently associated with women (OR = 0.964, 95% CI = 0.932-0.998 and OR = 2.438, 95% CI = 1.474-4.032, respectively) but not with men. It is suggested that socioeconomic inequality exists in healthcare access among adults aged 65 and over. Since income and gender are strongly associated with taking pain medication, physicians should follow-up on women and less affluent people to ensure that medication prescribed has been obtained. Policymakers should consider programs that would facilitate better access to pain medication among vulnerable older individuals.

Association of Geography and Access to Health Care Providers With Long-Term Prescription Opioid Use in Medicare Patients With Severe Osteoarthritis: A Cohort Study.

OBJECTIVE: To evaluate the variation in long-term opioid use in osteoarthritis (OA) patients according to geography and health care access. METHODS: We designed an observational cohort study among OA patients undergoing total joint replacement (TJR) in the Medicare program (2010 through 2014). The independent variables of interest were the state of residence and health care access, which was quantified at the primary care service area (PCSA) level as categories of number of practicing primary care providers (PCPs) and categories of rheumatologists per 1,000 Medicare beneficiaries. The percentage of OA patients taking long-term opioids (≥90 days in the 360-day period immediately preceding TJR) within each PCSA was the outcome variable in a multilevel, generalized linear regression model, adjusting for case-mix at the PCSA level and for policies, including rigor of prescription drug monitoring programs and legalized medical marijuana, at the state level. RESULTS: A total of 358,121 patients with advanced OA, with a mean age of 74 years, were included from 4,080 PCSAs. The unadjusted mean percentage of long-term opioid users varied widely across states, ranging from 8.9% (Minnesota) to 26.4% (Alabama), and this variation persisted in the adjusted models. Access to PCPs was only modestly associated with rates of long-term opioid use between PCSAs with highest (>8.6) versus lowest (<3.6) concentration of PCPs (adjusted mean difference 1.4% [95% confidence interval 0.8%, 2.0%]), while access to rheumatologists was not associated with long-term opioid use. CONCLUSION: We note a substantial statewide variation in rates of long-term treatment with opioids in OA, which is not fully explained by the differences in access to health care providers, varying case-mix, or state-level policies.

Racial and Ethnic Disparities in the Evaluation and Management of Pain in the Outpatient Setting, 2006-2015.

OBJECTIVE: Much is known about racial and ethnic disparities in receipt of opioids for pain in emergency departments. Less is known about such disparities in the evaluation and management of pain in the outpatient setting. METHODS: Using the nationally representative National Ambulatory Medical Care Survey (NAMCS), we estimated disparities in visit time with physicians and opioid receipt in the outpatient setting. We focused on patients whose reason for visiting was abdominal pain or back pain. Our sample included 4,764 white patients, 692 black patients, and 682 Hispanic patients. RESULTS: Back pain visits of Hispanic patients lasted 1.6 fewer minutes than those of white non-Hispanic patients (P = 0.04 for the difference). Black patients were 6.0% less likely than white patients to receive opioids for abdominal pain (P = 0.04 for the difference) and 7.1% less likely than white patients to receive opioids for back pain (P = 0.046 for the difference). Hispanic patients were 6.3% less likely than white patients to receive opioids for abdominal pain (P = 0.003 for the difference) and 14.8% less likely than white patients to receive opioids for back pain (P < 0.001 for the difference). Hispanic patients were more likely than white patients to receive nonopioids instead of opioids for both abdominal pain and back pain. Differences in opioid receipt did not narrow during the examined time period. CONCLUSIONS: Identifying causes of racial and ethnic disparities in the evaluation and treatment of pain in the outpatient setting is important to improving the health and function of patients.

Opioid Dependence and Health Care Utilization After Decompression and Fusion in Patients With Adult Degenerative Scoliosis.

STUDY DESIGN: Retrospective study. OBJECTIVE: To identify factors associated with opioid dependence after surgery for adult degenerative scoliosis (ADSc). SUMMARY OF BACKGROUND DATA: Opioid epidemic is of prodigious concern throughout the United States. METHODS: Data was extracted using national MarketScan database (2000-2016). Opioid dependence was defined as continued opioid use or >10 opioid prescriptions for 1 year either before or 3 to 15 months after the procedure. Patients were segregated into four groups based on opioid dependence before and postsurgery: NDND (before nondependent who remain non-dependent), NDD (before nondependent who become dependent), DND (before dependent who become non-dependent) and DD (before dependent who remain dependent). Outcomes were discharge disposition, length of stay, complications, and healthcare resource utilization. RESULTS: Approximately, 35.82% (n = 268) of patients were identified to have opioid dependence before surgery and 28.34% (n = 212) were identified to have opioid dependence after surgery for ADSc. After surgical fusion for ADSc, patients were twice likely to become opioid independent than they were to become dependent (13.77% vs. 6.28%, OR: 2.191, 95% CI: 21.552-3.094; P < 0.0001). Before opioid dependence (RR: 14.841; 95% CI: 9.867, 22.323; P < 0.0001) was identified as a significant predictor of opioid dependence after surgery for ADSc. In our study, 57.9%, 6.28%, 13.77%, and 22.06% of patients were in groups NDND, NDD, DND, and DD respectively. DD and NDD were likely to incur 3.03 and 2.28 times respectively the overall costs compared with patients' ingroup NDND (P < 0.0001), at 3 to 15 months postsurgery (median $21648 for NDD; $40,975 for DD; and $ 13571 for NDND groups). CONCLUSION: Surgery for ADSc was not associated with increased likelihood of opioid dependence, especially in opioid naïve patients. Patients on regular opiate treatment before surgery were likely to remain on opiates after surgery. Patients who continued to be opioid dependent or become dependent after surgery incur significantly higher healthcare utilization at 3 and 3 to 15 months. LEVEL OF EVIDENCE: 4.

Conducting an observational study during an economic crisis: analysis of the treatment and follow-up phase of Greek patients participating in the ExFOS study.

OBJECTIVE: We present the subanalysis of the Greek cohort of the Extended Forsteo Observational Study (ExFOS), a multicenter, non-interventional, prospective, observational study evaluating the effect of teriparatide on fractures, back pain (BP), health-related quality of life (HR-QoL), and safety and compliance, in patients with osteoporosis treated for up to 24 months, with a post-treatment follow-up of at least 18 months. DESIGN: A total of 439 osteoporotic patients (92.2% female) were enrolled in Greece. New or worsened fractures, based on their physicians' assessment, as well as patients' self-assessment of HR-QoL and BP, compliance, and safety profile, were captured by validated questionnaires. RESULTS: In the ExFOS Greek cohort, fracture rates were low and mean bone mineral density (BMD) was numerically improved. Compliance with teriparatide remained high throughout the study, with 81.5% of subjects completing treatment. Only 0.7% of patients reported discontinuation due to adverse effects. A sustainable improvement in patient-perceived BP and HRQoL throughout treatment and follow-up was similar to that achieved by the European Forsteo Observational Study (EFOS). A lower than expected percentage of patients using antiresorptives following teriparatide was recorded. CONCLUSIONS: ExFOS reproduces the outcomes of EFOS, with a 6.5-year time interval between studies, in comparable cohorts of osteoporotic patients. Data should be interpreted in the context of observational study data collection, although summary statistics computed at each time point may overstate drug effect.

Opioid Dependence and Prolonged Length of Stay in Lumbar Fusion: A Retrospective Study Utilizing the National Inpatient Sample 2003-2014.

STUDY DESIGN: Retrospective cohort utilizing the National Inpatient Sample (NIS) 2003 to 2014. OBJECTIVE: To investigate the association of opioid dependence with prolonged length of stay (LOS), costs, and surgical complications in elective one-to-two level lumbar fusion. SUMMARY OF BACKGROUND DATA: Opioids are the most commonly prescribed drug class to treat back pain. Few studies have examined the impact of opioid dependence on spinal fusion outcomes. The data available show inconsistent conclusions regarding the association between opioid dependence and LOS. METHODS: Data from 1,826,868 adult elective one-to-two level lumbar fusion discharges in the NIS from 2003 to 2014 were included. Discharges were categorized into an opioid-dependent or unaffected cohort based on the presence or absence of an International Classification of Disease, Ninth Revision-Clinical Modification (ICD-9-CM) code for opioid dependence. Incidence of opioid dependence was compared between 2003 and 2014 via adjusted Wald tests. Patient and surgical characteristics, costs, and complications were compared between cohorts via chi-square tests or adjusted Wald tests for categorical and continuous variables, respectively. Patient and surgical factors were tested for association with prolonged LOS via univariable logistic regressions, and significant (P ≤ 0.01) factors were included in a multivariable logistic regression. RESULTS: Seven thousand nine hundred sixty-four (0.44%) discharges included a diagnosis of opioid dependence. The incidence of opioid dependence increased from 2003 to 2014. Opioid dependence was associated with an adjusted 2.11 times higher odds of prolonged LOS. Opioid-dependent discharges accrued higher costs and had higher frequencies of infection, device-related complications, hematoma- or seroma-related complications, acute posthemorrhagic anemia, and pulmonary insufficiency. CONCLUSION: This nationally-representative study suggests that opioid dependence is associated with prolonged LOS in lumbar fusion, as well as higher costs and higher frequencies of surgical complications. Further investigations are needed to determine the optimal method to treat opioid-dependent patients who require lumbar fusion. LEVEL OF EVIDENCE: 3.