Zoya Bauer

University of Washington Seattle, Seattle, Washington, United States

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Publications (13)107.61 Total impact

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    ABSTRACT: Secondary analysis of data from a double-blind randomized controlled trial. To identify mediators of the effect of lumbar epidural injections of corticosteroid plus lidocaine on patient satisfaction at 6 weeks post-injection, in patients with lumbar spinal stenosis (LSS). We hypothesized that short-term (≤3 weeks) change in leg pain would be a significant mediator of satisfaction. No prior studies have identified mediators of effects of epidural injections on patient satisfaction with treatment for LSS. We used mediation analysis methods to examine selected intermediate variables (adverse events and change in leg pain, back pain, disability, depression, and fatigue at 3 weeks) as potential mediators of the effect of lumbar epidural injections of corticosteroid plus lidocaine on patient satisfaction with treatment. We used the overall satisfaction item from the Swiss Spinal Stenosis Questionnaire as our primary outcome to measure patient satisfaction with the injection procedure at 6 weeks. Among 400 patients randomized to receive epidural injections with corticosteroid plus lidocaine or with lidocaine alone, 369 had complete data for the satisfaction outcome and potential mediators, and served as the analysis sample. Contrary to our expectations, three-week change in leg pain intensity did not have significant mediation effects on patient satisfaction. Three-week change in disability as measured by the Roland-Morris Disability Questionnaire was a significant mediator of the effects of lumbar epidural corticosteroid injections on patient satisfaction at 6 weeks, explaining 48-60% of the treatment effect on satisfaction. Changes in pain intensity in the leg and back together explained very little of the treatment effect on satisfaction beyond the information contributed by disability change alone. We did not find other intermediate variables to be mediators of patient satisfaction. These findings support the current approach of examining disability as a primary patient-reported outcome in comparative effectiveness studies of LSS.
    Spine 05/2015; DOI:10.1097/BRS.0000000000001000 · 2.45 Impact Factor
  • Osteoarthritis and Cartilage 04/2015; 23:A200. DOI:10.1016/j.joca.2015.02.994 · 4.66 Impact Factor
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    ABSTRACT: 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. 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. 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. 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. 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). 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.
    JAMA The Journal of the American Medical Association 03/2015; 313(11):1143-1153. DOI:10.1001/jama.2015.1871 · 30.39 Impact Factor
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    ABSTRACT: There is growing concern that commonly used patient-reported outcomes (PROs) used in clinical research evaluating treatments such as epidural steroid injections (ESI) for lumbar spinal stenosis may not adequately capture outcomes of greatest important to older adults. To determine what outcomes are most important to older adults with spinal stenosis, how well commonly used PROs reflect what is most important to these participants and which outcomes older adults with spinal stenosis would want improved to consider having ESI. Outcomes prioritization study. Community sample of 33 older adults with spinal stenosis. Swiss Spinal Stenosis Questionnaire and Roland-Morris Disability Questionnaire. Individual sorting and ranking exercises followed by facilitated focus groups. This study was funded by a contract with the Patient-Centered Outcomes Research Institute (Contract # CE-12-11-4469). None of the authors have conflicts of interest to report related to this study. Highest rated problem areas were "Experiencing Pain/Discomfort" (88% of participants), "Problems with Physical Function" (85%), "Difficulty Exercising" (73%), "Difficulty Participating in Hobbies and Leisure Activities" (55%), and "Problems with Weakness" (52%). Only 10 of the 24 RMDQ items were rated by 50% or more of participants experiencing them as important enough to warrant ESI treatment. Older adults with spinal stenosis rated problems related to pain and physical function as the most important outcomes to them. "Difficulty Exercising" and "Difficulty Participating in Hobbies and Leisure Activities" were also among the most highly rated however, and are two areas not typically assessed in treatment studies. Commonly used PROs in spinal stenosis treatment studies may be insufficient to comprehensively assess outcomes from the patient perspective. Copyright © 2015 Elsevier Inc. All rights reserved.
    The spine journal: official journal of the North American Spine Society 03/2015; 15(7). DOI:10.1016/j.spinee.2015.03.008 · 2.80 Impact Factor
  • The Journal of Bone and Joint Surgery 02/2015; 97A(4):342-342. · 4.31 Impact Factor
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    ABSTRACT: Background Epidural glucocorticoid injections are widely used to treat symptoms of lumbar spinal stenosis, a common cause of pain and disability in older adults. However, rigorous data are lacking regarding the effectiveness and safety of these injections. Methods In a double-blind, multisite trial, we randomly assigned 400 patients who had lumbar central spinal stenosis and moderate-to-severe leg pain and disability to receive epidural injections of glucocorticoids plus lidocaine or lidocaine alone. The patients received one or two injections before the primary outcome evaluation, performed 6 weeks after randomization and the first injection. The primary outcomes were the score on the Roland-Morris Disability Questionnaire (RMDQ, in which scores range from 0 to 24, with higher scores indicating greater physical disability) and the rating of the intensity of leg pain (on a scale from 0 to 10, with 0 indicating no pain and 10 indicating "pain as bad as you can imagine"). Results At 6 weeks, there were no significant between-group differences in the RMDQ score (adjusted difference in the average treatment effect between the glucocorticoid-lidocaine group and the lidocaine-alone group, -1.0 points; 95% confidence interval [CI], -2.1 to 0.1; P = 0.07) or the intensity of leg pain (adjusted difference in the average treatment effect, -0.2 points; 95% CI, -0.8 to 0.4; P = 0.48). A pre-specified secondary subgroup analysis with stratification according to type of injection (interlaminar vs. transforaminal) likewise showed no significant differences at 6 weeks. Conclusions In the treatment of lumbar spinal stenosis, epidural injection of glucocorticoids plus lidocaine offered minimal or no short-term benefit as compared with epidural injection of lidocaine alone. (Funded by the Agency for Healthcare Research and Quality; ClinicalTrials.gov number, NCT01238536.)
    New England Journal of Medicine 07/2014; 371(1):11-21. DOI:10.1056/NEJMoa1313265 · 54.42 Impact Factor
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    ABSTRACT: Back pain represents a substantial burden globally, ranking first in a recent assessment among causes of years lived with disability. Though back pain is widely studied among working age adults, there are gaps with respect to basic descriptive epidemiology among seniors, especially in the United States. Our goal was to describe how pain, function and health-related quality of life vary by demographic and geographic factors among seniors presenting to primary care providers with new episodes of care for back pain. We examined baseline data from the Back pain Outcomes using Longitudinal Data (BOLD) registry, the largest inception cohort to date of seniors presenting to a primary care provider for back pain. The sample included 5,239 patients >= 65 years old with a new primary care visit for back pain at three integrated health systems (Northern California Kaiser-Permanente, Henry Ford Health System [Detroit], and Harvard Vanguard Medical Associates [Boston]). We examined differences in patient characteristics across healthcare sites and associations of patient sociodemographic and clinical characteristics with baseline patient-reported measures of pain, function, and health-related quality of life. Patients differed across sites in demographic and other characteristics. The Detroit site had more African-American patients (50%) compared with the other sites (7-8%). The Boston site had more college graduates (68%) compared with Detroit (20%). Female sex, lower educational status, African-American race, and older age were associated with worse functional disability as measured by the Roland-Morris Disability Questionnaire. Except for age, these factors were also associated with worse pain. Baseline pain and functional impairment varied substantially with a number of factors in the BOLD cohort. Healthcare site was an important factor. After controlling for healthcare site, lower education, female sex, African-American race, and older age were associated with worse physical disability and all of these factors except age were associated with worse pain.Trial registration: Clinical Trials.gov NCT01776242; Registration date: June 13, 2012.
    BMC Musculoskeletal Disorders 04/2014; 15(1):134. DOI:10.1186/1471-2474-15-134 · 1.90 Impact Factor
  • 01/2014; DOI:10.2147/CER.S59136
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    ABSTRACT: PURPOSE To describe how pain, functional status and health related quality-of-life vary by demographic factors among seniors presenting to primary care providers with new episodes of low back pain. METHOD AND MATERIALS We enrolled patients ≥ 65 years old who presented to a primary care provider with a new episode of back pain. We recruited study participants from three integrated health systems (Kaiser-P N CA, Henry Ford-Detroit and Harvard Vanguard Med Assoc -Boston). Baseline measures included: 1) Roland-Morris Disability Questionnaire (RMDQ); 2) 0-10 pain numerical rating scales (NRS); 3) Brief Pain Inventory (BPI); 4) Patient Health Questionnaire (PHQ)-4; 5) EuroQol-5D (EQ5D); 6) Pain duration; 7) Patient expectations. We examined demographic characteristics, comparing the three recruitment sites. We used the chi-square test to compare categorical variables and unpaired t-tests to compare numerical variables and the Mann-Whitney U-test when appropriate. RESULTS We enrolled 5,288 patients. RMDQ had a small increase with age, from a mean (SD) of 9.1(6.6) at ages 65-69 to a mean of 10.7(6.1) for those greater than 85. The average pain duration also increased with age (32% of those 65-69 having had pain of more than a year compared with 44% >85). The oldest age group had slightly lower confidence (4.9(3.7) vs. 5.6(3.7)) that they would be pain-free or substantially improved by 3 months. African American (AA) patients were worse on most baseline measures of function and pain. Eg: the mean/median RMDQ scores were 12.1/13 in AAs compared with 8.8/8 for Caucasians. Because over 50% of AAs were at Detroit, confounding by site may be a factor. However, within a given site, AAs had worse scores than Caucasians by more than 1 point on the Roland scale There were substantial differences between sites with respect to potentially important prognostic demographic factors and baseline reported measures. CONCLUSION We observed substantial differences of our baseline measures between sites, emphasizing the need for caution when pooling results from a multicenter study. African-Americans appeared to have worse back-related health status in our cohort although confounding by site was present. CLINICAL RELEVANCE/APPLICATION There is great heterogenity between sites with respect to baseline characteristics of seniors with back pain. Worse health status among African-Americans may be explained, in part, by site factors.
    Radiological Society of North America 2013 Scientific Assembly and Annual Meeting; 12/2013
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    Value in Health 06/2012; 15(4):A47. DOI:10.1016/j.jval.2012.03.263 · 2.89 Impact Factor
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    ABSTRACT: 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. 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. 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.
    BMC Musculoskeletal Disorders 05/2012; 13(1):64. DOI:10.1186/1471-2474-13-64 · 1.90 Impact Factor
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    ABSTRACT: 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. 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. 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. Clinicaltrials.gov NCT01238536.
    BMC Musculoskeletal Disorders 03/2012; 13:48. DOI:10.1186/1471-2474-13-48 · 1.90 Impact Factor