Expected Organizational Costs for Inserting Prevalence Information Into Lumbar Spine Imaging Reports.

BACKGROUND: Modifying physician behavior to more closely align with guideline-based care can be challenging. Few effective strategies resulting in appropriate spine-related health care have been reported. The Lumbar Imaging With Reporting of Epidemiology (LIRE) intervention did not result in reductions in spine care but did in opioid prescriptions written. OBJECTIVES: To estimate organizational resource needs and costs associated with implementing a pragmatic, decision support-type intervention that inserted age- and modality-matched prevalence information for common lumbar spine imaging findings, using site-based resource use data from the LIRE trial. RESEARCH DESIGN: Time and cost estimation associated with implementing the LIRE intervention in a health organization. SUBJECTS: Providers and patients assessed in the LIRE trial. MEASURES: Expected personnel costs required to implement the LIRE intervention. RESULTS: Annual salaries were converted to daily average per person costs, ranging from $400 to $2,200 per day (base case) for personnel (range: $300-$2,600). Estimated total average cost for implementing LIRE was $5,009 (range: $2,651-$12,020), including conducting pilot testing with providers. Costs associated with a small amount of time for a radiologist (6-12 hours) and imaging-ordering providers (1-8 hours each) account for approximately 75% of the estimated total cost. CONCLUSIONS: The process of implementing an intervention for lumbar spine imaging reports containing age- and modality-appropriate epidemiological benchmarks for common imaging findings required radiologists, imaging-ordering providers, information technology specialists, and limited testing and monitoring. The LIRE intervention seems to be a relatively low-cost, evidence-based, complementary tool that can be easily integrated into the reporting of spine imaging.

The Effect of Including Benchmark Prevalence Data of Common Imaging Findings in Spine Image Reports on Health Care Utilization Among Adults Undergoing Spine Imaging: A Stepped-Wedge Randomized Clinical Trial.

Importance: Lumbar spine imaging frequently reveals findings that may seem alarming but are likely unrelated to pain. Prior work has suggested that inserting data on the prevalence of imaging findings among asymptomatic individuals into spine imaging reports may reduce unnecessary subsequent interventions. Objective: To evaluate the impact of including benchmark prevalence data in routine spinal imaging reports on subsequent spine-related health care utilization and opioid prescriptions. Design, Setting, and Participants: This stepped-wedge, pragmatic randomized clinical trial included 250 401 adult participants receiving care from 98 primary care clinics at 4 large health systems in the United States. Participants had imaging of their backs between October 2013 and September 2016 without having had spine imaging in the prior year. Data analysis was conducted from November 2018 to October 2019. Interventions: Either standard lumbar spine imaging reports (control group) or reports containing age-appropriate prevalence data for common imaging findings in individuals without back pain (intervention group). Main Outcomes and Measures: Health care utilization was measured in spine-related relative value units (RVUs) within 365 days of index imaging. The number of subsequent opioid prescriptions written by a primary care clinician was a secondary outcome, and prespecified subgroup analyses examined results by imaging modality. Results: We enrolled 250 401 participants (of whom 238 886 [95.4%] met eligibility for this analysis, with 137 373 [57.5%] women and 105 497 [44.2%] aged >60 years) from 3278 primary care clinicians. A total of 117 455 patients (49.2%) were randomized to the control group, and 121 431 patients (50.8%) were randomized to the intervention group. There was no significant difference in cumulative spine-related RVUs comparing intervention and control conditions through 365 days. The adjusted median (interquartile range) RVU for the control group was 3.56 (2.71-5.12) compared with 3.53 (2.68-5.08) for the intervention group (difference, -0.7%; 95% CI, -2.9% to 1.5%; P = .54). Rates of subsequent RVUs did not differ between groups by specific clinical findings in the report but did differ by type of index imaging (eg, computed tomography: difference, -29.3%; 95% CI, -42.1% to -13.5%; magnetic resonance imaging: difference, -3.4%; 95% CI, -8.3% to 1.8%). We observed a small but significant decrease in the likelihood of opioid prescribing from a study clinician within 1 year of the intervention (odds ratio, 0.95; 95% CI, 0.91 to 1.00; P = .04). Conclusions and Relevance: In this study, inserting benchmark prevalence information in lumbar spine imaging reports did not decrease subsequent spine-related RVUs but did reduce subsequent opioid prescriptions. The intervention text is simple, inexpensive, and easily implemented. Trial Registration: ClinicalTrials.gov Identifier: NCT02015455.

Effect of Comorbid Knee and Hip Osteoarthritis on Longitudinal Clinical and Health Care Use Outcomes in Older Adults With New Visits for Back Pain.

OBJECTIVE: To examine if a comorbid diagnosis of knee or hip osteoarthritis (OA) in older adults with new back pain visits is associated with long-term patient-reported outcomes and back-related health care use. DESIGN: Prospective cohort study. SETTING: Three integrated health systems forming the Back pain Outcomes using Longitudinal Data cohort. PARTICIPANTS: Participants (N=5155) were older adults (≥65y) with a new visit for back pain and a complete electronic health record data. INTERVENTIONS: Not applicable; we obtained OA diagnoses using diagnostic codes in the electronic health record 12 months prior to the new back pain visit. MAIN OUTCOME MEASURES: The Roland-Morris Disability Questionnaire (RDQ) and the EuroQol-5D (EQ-5D) were key patient-reported outcomes. Health care use, measured by relative-value units (RVUs), was summed for the 12 months after the initial visit. We used linear mixed-effects models to model patient-reported outcomes. We also used generalized linear models to test the association between comorbid knee or hip OA and total back-related RVUs. RESULTS: Of the 5155 participants, 368 (7.1%) had a comorbid knee OA diagnosis, and 94 (1.8%) had a hip OA diagnosis. Of the participants, 4711 (91.4%) had neither knee nor hip OA. In adjusted models, the 12-month RDQ score was 1.23 points higher (95% confidence interval [CI], 0.72-1.74) for patients with knee OA and 1.26 points higher (95% CI, 0.24-2.27) for those with hip OA than those without knee or hip OA, respectively. A lower EQ-5D score was found among participants with knee OA (.02 lower; 95% CI, -.04 to -.01) and hip OA diagnoses (.03 lower; 95% CI, -.05 to -.01) compared with those without knee or hip OA, respectively. Comorbid knee or hip OA was not significantly associated with total 12-month back-related resource use. CONCLUSIONS: Comorbid knee or hip OA in older adults with a new back pain visit was associated with modestly worse long-term disability and health-related quality of life.

Cross-Sectional Assessment of Factors Related to Pain Intensity and Pain Interference in Lower Limb Prosthesis Users.

OBJECTIVE: To determine relationships between pain sites and pain intensity/interference in people with lower limb amputations (LLAs). DESIGN: Cross-sectional survey. SETTING: Community. PARTICIPANTS: Lower limb prosthesis users with unilateral or bilateral amputations (N=1296; mean time since amputation, 14.1y). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Patient-Reported Outcomes Measurement Information System (PROMIS) pain intensity (1 item to assess average pain), PROMIS pain interference (4-item short form to assess the consequences of pain in desired activities), and questions that asked participants to rate the extent to which each of the following were a problem: residual limb pain (RLP), phantom limb pain (PLP), knee pain on the nonamputated side, back pain, and shoulder pain. RESULTS: Nearly three quarters (72.1%) of participants reported problematic pain in 1 or more of the listed sites. Problematic PLP, back pain, and RLP were reported by 48.1%, 39.2%, and 35.1% of participants, respectively. Knee pain and shoulder pain were less commonly identified as problems (27.9% and 21.7%, respectively). Participants also reported significantly (P<.0001) higher pain interference (T-score ± SD, 54.7±9.0) than the normative sample based on the U.S. population (T-score ± SD, 50.0±10.0). Participants with LLAs rated their pain intensity on average ± SD at 3.3±2.4 on a 0-to-10 scale. Pain interference (ρ=.564, P<.0001) and intensity (ρ=.603, P<.0001) were positively and significantly correlated with number of pain sites reported. CONCLUSIONS: Problematic pain symptoms, especially RLP, PLP, and back pain, affect most prosthetic limb users and have the potential to greatly restrict participation in life activities.

Role of Health Services Research in Producing High-Value Rehabilitation Care.

The concept of value is receiving greater attention in rehabilitation and the broader health care environment. The overall purpose of this article is to present a framework to help clinicians, researchers, educators, and policy makers better understand the role of health services research in developing and evaluating evidence on value in rehabilitation. Value in health care is a multidimensional concept and may be defined differently by various stakeholders, but assessing value typically involves considering a combination of several health and economic outcomes. However, health care stakeholders often lack sufficient information on these outcomes to make well-informed decisions. Health services approaches such as comparative effectiveness research, patient-centered outcomes research, and health economics assessments are some ways to evaluate value. The evidence generated from such studies directly informs decision making and health policy. Rehabilitation professionals have a great opportunity to increase their engagement in describing, evaluating, delivering, and disseminating high-value care, but there are several barriers they need to consider to be most successful. Embracing health services research best practices is essential for advancing appropriate rehabilitation practice, research, and policy and for addressing challenges to implementing high-value care.

Association of early imaging for back pain with clinical outcomes in older adults.

IMPORTANCE: In contrast to the recommendations for younger adults, many guidelines allow for older adults with back pain to undergo imaging without waiting 4 to 6 weeks. However, early imaging may precipitate interventions that do not improve outcomes. OBJECTIVE: To compare function and pain at the 12-month follow-up visit among older adults who received early imaging with those who did not receive early imaging after a new primary care visit for back pain without radiculopathy. DESIGN, SETTING, AND PARTICIPANTS: Prospective cohort of 5239 patients 65 years or older with a new primary care visit for back pain (2011-2013) in 3 US health care systems. We matched controls 1:1 using propensity score matching of demographic and clinical characteristics, including diagnosis, pain severity, pain duration, functional status, and prior resource use. EXPOSURES: Diagnostic imaging (plain films, computed tomography [CT], magnetic resonance imaging [MRI]) of the lumbar or thoracic spine within 6 weeks of the index visit. PRIMARY OUTCOME: back or leg pain-related disability measured by the modified Roland-Morris Disability Questionnaire (score range, 0-24; higher scores indicate greater disability) 12 months after enrollment. RESULTS: Among the 5239 patients, 1174 had early radiographs and 349 had early MRI/CT. At 12 months, neither the early radiograph group nor the early MRI/CT group differed significantly from controls on the disability questionnaire. The mean score for patients who underwent early radiography was 8.54 vs 8.74 among the control group (difference, -0.10 [95% CI, -0.71 to 0.50]; mixed model, P = .36). The mean score for the early MRI/CT group was 9.81 vs 10.50 for the control group (difference,-0.51 [-1.62 to 0.60]; mixed model, P = .18). CONCLUSIONS AND RELEVANCE: Among older adults with a new primary care visit for back pain, early imaging was not associated with better 1-year outcomes. The value of early diagnostic imaging in older adults for back pain without radiculopathy is uncertain.

Mapping a patient-reported functional outcome measure to a utility measure for comparative effectiveness and economic evaluations in older adults with low back pain.

BACKGROUND: Linking patient-reported back pain outcomes with health utility measures is valuable for informing economic evaluations. METHODS: We used the Back pain Outcomes using Longitudinal Data (BOLD) registry to assess back pain and quality-of-life measures. The BOLD registry includes participants ≥65 years from 3 health systems. We used multiple baseline outcome measures: Roland-Morris Disability Questionnaire (RMDQ), Euroqol-5D (EQ-5D), and back and leg pain numerical rating scales (NRS). To develop and validate a model, we used a standard split-sample method and a novel multisite validation approach. We applied linear regression to map RMDQ to EQ-5D, adjusting for age, sex, pain numerical rating scores, and nonlinear transformations of outcome measures. We computed R (2), root mean squared error, and mean absolute error (MAE) for purposes of model selection. The final model included EQ-5D as the dependent variable with independent variables of age, RMDQ, and back NRS. We used this model to predict EQ-5D scores in validation samples. RESULTS: In total, 5224 participants had both baseline RMDQ and EQ-5D. Mean age was 74 years (65% female). Negative correlations (-0.72) were observed at baseline for RMDQ and EQ-5D. The selected model from all developmental samples had R (2) >0.41 and MAE < 0.119. Validation analyses indicated no differences in estimated v. observed mean EQ-5D scores in the split sample. Validation using the multisite validation approach identified prediction error variability, MAE of 0.081 to 0.119, when predicting EQ-5D. LIMITATIONS: The statistical relationship may not generalize well to all study populations as we demonstrated in our multisite analysis. CONCLUSIONS: An empirical algorithm predicting EQ-5D weights from RMDQ scores provides a currently unavailable link for conducting economic evaluations in low back pain studies.

A systematic review to assess comparative effectiveness studies in epidural steroid injections for lumbar spinal stenosis and to estimate reimbursement amounts.

OBJECTIVE: To systematically appraise published comparative effectiveness evidence (clinical and economic) of epidural steroid injections (ESI) for lumbar spinal stenosis and to estimate Medicare reimbursement amounts for ESI procedures. TYPE: Systematic review. LITERATURE SURVEY: PubMed, Embase, and CINAHL were searched through August 2012 for key words that pertain to low back pain, spinal stenosis or sciatica, and epidural steroid injection. We used institutional and Medicare reimbursement amounts for our cost estimation. Articles published in English that assessed ESIs for adults with lumbar spinal stenosis versus a comparison intervention were included. Our search identified 146 unique articles, and 138 were excluded due to noncomparative study design, not having a study population with lumbar spinal stenosis, not having an appropriate outcome, or not being in English. We fully summarized 6 randomized controlled trials and 2 large observational studies. METHODOLOGY: Randomized controlled trial articles were reviewed, and the study population, sample size, treatment groups, ESI dosage, ESI approaches, concomitant interventions, outcomes, and follow-up time were reported. Descriptive resource use estimates for ESIs were calculated with use of data from our institution during 2010 and Medicare-based reimbursement amounts. SYNTHESIS: ESIs or anesthetic injections alone resulted in better short-term improvement in walking distance compared with control injections. However, there were no longer-term differences. No differences between ESIs versus anesthetic in self-reported improvement in pain were reported. Transforaminal approaches had better improvement in pain scores (≤4 months) compared with interlaminar injections. Two observational studies indicated increased rates of lumbar ESI in Medicare beneficiaries. Our sample included 279 patients who received at least 1 ESI during 2010, with an estimated mean total outpatient reimbursement for one ESI procedure "event" to be $637, based on 2010 Medicare reimbursement amounts ($505 technical and $132 professional payments). CONCLUSION: This systematic review of ESI for treating lumbar spinal stenosis found a limited amount of data that suggest that ESI is effective in some patients for improving select short-term outcomes, but results differed depending on study design, outcome measures used, and comparison groups evaluated. Overall, there are relatively few comparative clinical or economic studies for ESI procedures for lumbar spinal stenosis in adults, which indicated a need for additional evidence.

Study protocol: the Back Pain Outcomes using Longitudinal Data (BOLD) registry.

BACKGROUND: Back pain is one of the most important causes of functional limitation, disability, and utilization of health care resources for adults of all ages, but especially among older adults. Despite the high prevalence of back pain in this population, important questions remain unanswered regarding the comparative effectiveness of commonly used diagnostic tests and treatments in the elderly. The overall goal of the Back pain Outcomes using Longitudinal Data (BOLD) project is to establish a rich, sustainable registry to describe the natural history and evaluate prospectively the effectiveness, safety, and cost-effectiveness of interventions for patients 65 and older with back pain. METHODS/DESIGN: BOLD is enrolling 5,000 patients ≥ 65 years old who present to a primary care physician with a new episode of back pain. We are recruiting study participants from three integrated health systems (Kaiser-Permanente Northern California, Henry Ford Health System in Detroit and Harvard Vanguard Medical Associates/ Harvard Pilgrim Health Care in Boston). Registry patients complete validated, standardized measures of pain, back pain-related disability, and health-related quality of life at enrollment and 3, 6 and 12 months later. We also have available for analysis the clinical and administrative data in the participating health systems' electronic medical records. Using registry data, we will conduct an observational cohort study of early imaging compared to no early imaging among patients with new episodes of back pain. The aims are to: 1) identify predictors of early imaging and; 2) compare pain, functional outcomes, diagnostic testing and treatment utilization of patients who receive early imaging versus patients who do not receive early imaging. In terms of predictors, we will examine patient factors as well as physician factors. DISCUSSION: By establishing the BOLD registry, we are creating a resource that contains patient-reported outcome measures as well as electronic medical record data for elderly patients with back pain. The richness of our data will allow better matching for comparative effectiveness studies than is currently possible with existing datasets. BOLD will enrich the existing knowledge base regarding back pain in the elderly to help clinicians and patients make informed, evidence-based decisions regarding their care.

Study protocol- Lumbar Epidural steroid injections for Spinal Stenosis (LESS): a double-blind randomized controlled trial of epidural steroid injections for lumbar spinal stenosis among older adults.

BACKGROUND: Lumbar spinal stenosis is one of the most common causes of low back pain among older adults and can cause significant disability. Despite its prevalence, treatment of spinal stenosis symptoms remains controversial. Epidural steroid injections are used with increasing frequency as a less invasive, potentially safer, and more cost-effective treatment than surgery. However, there is a lack of data to judge the effectiveness and safety of epidural steroid injections for spinal stenosis. We describe our prospective, double-blind, randomized controlled trial that tests the hypothesis that epidural injections with steroids plus local anesthetic are more effective than epidural injections of local anesthetic alone in improving pain and function among older adults with lumbar spinal stenosis. METHODS: We will recruit up to 400 patients with lumbar central canal spinal stenosis from at least 9 clinical sites over 2 years. Patients with spinal instability who require surgical fusion, a history of prior lumbar surgery, or prior epidural steroid injection within the past 6 months are excluded. Participants are randomly assigned to receive either ESI with local anesthetic or the control intervention (epidural injections with local anesthetic alone). Subjects receive up to 2 injections prior to the primary endpoint at 6 weeks, at which time they may choose to crossover to the other intervention.Participants complete validated, standardized measures of pain, functional disability, and health-related quality of life at baseline and at 3 weeks, 6 weeks, and 3, 6, and 12 months after randomization. The primary outcomes are Roland-Morris Disability Questionnaire and a numerical rating scale measure of pain intensity at 6 weeks. In order to better understand their safety, we also measure cortisol, HbA1c, fasting blood glucose, weight, and blood pressure at baseline, and at 3 and 6 weeks post-injection. We also obtain data on resource utilization and costs to assess cost-effectiveness of epidural steroid injection. DISCUSSION: This study is the first multi-center, double-blind RCT to evaluate the effectiveness of epidural steroid injections in improving pain and function among older adults with lumbar spinal stenosis. The study will also yield data on the safety and cost-effectiveness of this procedure for older adults. TRIAL REGISTRATION: Clinicaltrials.gov NCT01238536.