Correlating Patient-Reported Outcomes to Patient Satisfaction in Patients with a Lumbar Disc Herniation

Correlating Patient-Reported Outcomes to Patient Satisfaction in Patients with a Lumbar Disc Herniation

NASS 31st Annual Meeting Proceedings / The Spine Journal 16 (2016) S113–S250 PURPOSE: The purpose of this study is to report preliminary clinical and ...

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NASS 31st Annual Meeting Proceedings / The Spine Journal 16 (2016) S113–S250 PURPOSE: The purpose of this study is to report preliminary clinical and radiologic results of SELD for the treatment of LDH in a single center experience. STUDY DESIGN/SETTING: Retrospective investigational study. PATIENT SAMPLE: Twenty-one patients (M:F=3:4) who underwent SELD for the treatment of single-level LDH were retrospectively evaluated for minimal 12-month follow-up. Their medical records including demographic data, diagnosis, complication, epiduroscopic findings and degree of symptom relief were investigated. OUTCOME MEASURES: Clinical outcome were evaluated using visual analog scale (VAS) scores for back and leg pain and functional status was measured with Oswestry disability index (ODI). Radiologic outcome were evaluated by comparing the changes of disc size on magnetic resonance image (MRI) scans, preoperatively, postoperatively and at final follow-up. METHODS: All patients received the same routine protocol procedures under local anesthesia by a single surgeon using Ho:Yag laser. RESULTS: Fifteen patients (71.4%) showed symptom relief immediate postoperatively after the procedure and 18 patients (85.7%) showed relief at final follow-up. The average VAS scores for back pain decreased from 8.2 to 3.5 at immediate postoperative and to 1.5 at final follow-up. The average VAS scores for leg pain decreased from 6.9 to 2.75 at immediate postoperative to 2.35 at final follow-up, respectively. Mean ODI improved from 48 to 23 postoperatively and further decreased to 14 at final follow-up. Immediate postoperative MRI showed subtle changes in most of the patients (18/21, 85.7%); however, final follow-up images revealed significant reduction of disc pathology in 80.9% (17/21 patients). There was no procedure related complication in all patients except mild headache after the operation in two patients. One patient received microdiscectomy under general anesthesia due to recurrence of disc herniation after 3 months. CONCLUSIONS: The results of this preliminary study show significant improvements of VAS score and ODI after SELD for LDH with back and leg pain at minimal 12 months of follow-up. Postoperative MRI scans revealed significant decrement of the disc size and reduction of neural compression. The SELD is suggested to be an effective therapeutic modality for patients with symptomatic LDH. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. http://dx.doi.org/10.1016/j.spinee.2016.07.138 122. Greater Expectations of Pain Improvement are Associated with Less Actual Pain Improvement after Lumbar Surgery Carol A. Mancuso, MD1, Manney Reid, MD, PhD2, Roland Duculan, MD1, Alex Fong, BA1, Manuela C. Rigaud, MA1, Frank P. Cammisa, MD1, Andrew A. Sama, MD1, Alexander P. Hughes, MD1, Darren R. Lebl, MD1, Federico P. Girardi, MD1; 1Hospital for Special Surgery, New York, NY, USA; 2Weill Cornell Medicine, New York, NY, USA BACKGROUND CONTEXT: Pain relief is a major outcome of lumbar surgery and can be measured with global assessments that capture both the intensity and affective components of pain. Patients undergo elective lumbar surgery because they have expectations for outcomes, particularly pain relief. Whether expectations for pain relief predict actual pain relief has not been assessed. We previously described a validated survey that measures both preop expectations (including for pain relief) and postop fulfillment of expectations. PURPOSE: The objectives of this study were to measure global pain improvement 2 years postop and to determine whether this outcome was associated with amount of pain improvement expected preop. STUDY DESIGN/SETTING: Cohort study with 2.2 year postop followup at a tertiary care spine center. PATIENT SAMPLE: Four hundred twenty-two patients who had lumbar spine surgery. OUTCOME MEASURES: Lumbar Spine Surgery Expectations Survey. METHODS: Patients scheduled for lumbar surgery were asked about their expectations of surgery using a validated survey that includes an item specifically asking about expected pain improvement with response options of “complete,” “a lot,” “a moderate amount,” and “a little.” Patients also rated back and leg pain intensity on a 0–10 scale and completed a survey for de-

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pressive symptoms. Clinical information included diagnosis, number of vertebral levels involved, and whether this was revision surgery. At a two-year followup, patients were asked a global question about how much pain improvement they received with response options of “complete,” “a lot,” “a moderate amount,” “a little,” and “no improvement.” Patients also rated the intensity of current back and leg pain (0–10), and reported on any subsequent spine surgery. RESULTS: Patients had the following characteristics: mean age 56 years, 55% men, 78% degenerative diagnosis, 44% taking opioids, and median back (7) and leg (6) pain intensities. Most patients expected a lot (44%) or complete (45%) pain improvement. Regarding postop actual pain improvement, 11% reported no improvement and 89% reported at least some improvement (28% a little to moderate improvement, 44% a lot, and 17% complete improvement). In multivariable analysis, patients had less improvement if they expected greater pain improvement (OR 1.4), had symptoms longer (OR 1.6), had a positive screen for depression (OR 1.7), were having revision surgery (OR 1.6), had surgery at L4 or L5 (OR 2.5), had a degenerative diagnosis (OR 1.6), had a subsequent surgery (OR 2.8), and had less decrease in back (OR 1.3) and leg pain intensity (OR 1.1) (p<.05 for all comparisons). Although most patients (89%) had some improvement, 56% did not have their expectation for pain relief fulfilled (ie, 77% who expected complete improvement, 40% who expected a lot, 40% who expected moderate, and 30% who expected a little improvement). CONCLUSIONS: Most patients had improvement in back pain 2 years postop, but the amount of improvement often was less than the amount expected. This was particularly true for patients who expected complete pain relief, which most likely was an unrealistic expectation for their clinical scenario. Less improvement was associated with multiple demographic and clinical variables, including greater preop expectations for pain relief. Because expectations are potentially modifiable, addressing patients’ expectations for pain relief should be part of comprehensive preop management. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. http://dx.doi.org/10.1016/j.spinee.2016.07.139 123. Correlating Patient-Reported Outcomes to Patient Satisfaction in Patients with a Lumbar Disc Herniation Gregory D. Schroeder, MD1, Alan S. Hilibrand, MD2, Alexander R. Vaccaro, MD, PhD2, Wenyan Zhao, PhD3, Jon D. Lurie, MD4, Kris E. Radcliff, MD5; 1Rothman Institute Thomas Jefferson University, Philadelphia, PA, USA; 2Rothman Institute, Philadelphia, PA, USA; 3Hanover, NH, USA; 4Dartmouth College, Lebanon, NH, USA; 5Rothman Institute, Thomas Jefferson University, Egg Harbor Township, NJ, USA BACKGROUND CONTEXT: Patient satisfaction is becoming an increasing common proxy for treatment quality; however, the correlation between patient satisfaction and health related quality of life (HRQOL) outcome metrics following a lumbar disc herniation is unclear. PURPOSE: To determine if patient satisfaction is predicted by improvement in HRQOL metrics in patients with a lumbar disc herniation. STUDY DESIGN/SETTING: Retrospective subgroup analysis of prospectively collected data from the Spine Patient Outcomes Research Trial (SPORT). PATIENT SAMPLE: Patients enrolled in the SPORT study were prospectively enrolled at 13 institutions. OUTCOME MEASURES: Receiver-operating characteristic (ROC) curves were used to determine if improvement in different HRQOL metrics could accurately identify patient satisfaction. Changes in the HRQOL metrics were considered the diagnostic test, and patient satisfaction was used as the external criterion. For this ROC analysis, the area under the curve (AUC) is the probability of the changes in the HRQOL measure accurately differentiating patient satisfaction. The AUC is commonly interpreted such that a value of less than 0.50 representing no accuracy; a value between 0.50 and 0.70 representing poor accuracy; a value between 0.70 and 0.80 representing moderate accuracy, and a value greater than 0.8 representing excellent accuracy. Additionally, logistic regression was used to explore which variables maintained significance after adjusting for other variables.

Refer to onsite annual meeting presentations and postmeeting proceedings for possible referenced figures and tables. Authors are responsible for accurately reporting disclosure and FDA device/drug status at time of abstract submission.

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NASS 31st Annual Meeting Proceedings / The Spine Journal 16 (2016) S113–S250

METHODS: In the SPORT study, patient satisfaction was graded as either: very satisfied, somewhat satisfied, neutral, somewhat dissatisfied, or very dissatisfied; however, for this study, patients were considered satisfied if they were either very satisfied or somewhat satisfied, and they were not satisfied if they were somewhat dissatisfied or very dissatisfied. HQOL metrics included: SF-36 and Oswestry Disability Index (ODI). RESULTS: Seven hundred and nine patients who underwent surgery and 319 patients treated without surgery were included. In the surgical cohort, ROC analysis demonstrated that SF-36 PCS improvement had a moderate accuracy (AUC=0.77 (0.73–0.82)) at predicting satisfaction at three months, and it had an excellent accuracy at predicting satisfaction at two years (AUC=0.81 [0.77–0.85]) and four years (AUC=0.81 [0.76–0.85]). Absolute PCS score had excellent accuracy at three months (AUC=0.83 [0.79–0.87]), two years (AUC=0.87 [0.84–0.9]) and four years (AUC=0.84 [0.8–0.89]). Similarly, improvement in the ODI had a moderate accuracy of predicting satisfaction at three months (AUC=0.77 [0.72–0.81]), two years (AUC=0.78 [0.74–0.82]) and four years (AUC=0.78 [0.73–0.83]), and the absolute ODI score had excellent accuracy at three months (AUC=0.85 [0.82–0.89]), two years (AUC=0.89 [0.86–0.92]) and four years (AUC=0.88 [0.85–0.92]).Separate logistic regression models were required to determine individual impact of SF-36 PCS improvement, SF-36PCS score, ODI improvement and ODI score on patient satisfaction. SF-36PCS improvement, ODI improvement and ODI score were found to be independent predictors of patient satisfaction at all-time points (p≤.005), but the SF-36 PCS score was only a significant predictor at three months and two years (p<.001). Both the results of the ROC and regression analysis were similar for the non-operative cohort. CONCLUSIONS: Patient satisfaction is an accurate proxy for HRQOL metrics three months, two years and four years after a lumbar disc herniation. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. http://dx.doi.org/10.1016/j.spinee.2016.07.140

Thursday, October 27, 2016 1:05 PM – 2:05 PM The Spine Journal Outstanding Paper Awards Presentations Outstanding Paper: Medical/Interventional Science Modifiable Risk Factors for Chronic Back Pain: Insights Using the Co-Twin Control Design Pradeep Suri, MD, MS1,2,3, Edward J. Boyko, MD, MPH1,4, Nicholas L. Smith, PhD1,5, Jeffrey G. Jarvik, MD, MPH6,7, Frances M. Williams, MD PhD8, Gail P. Jarvik, MD PhD9, Jack Goldberg, PhD1,5; 1Seattle Epidemiologic Research and Information Center, VA Puget Sound Health Care System, Seattle, WA, USA; 2Division of Rehabilitation Care Services, VA Puget Sound Health Care System, Seattle, WA, USA; 3Department of Rehabilitation Medicine, University of Washington, Seattle, WA, USA; 4General Medicine Service, VA Puget Sound Health Care System, Seattle, WA, USA; 5Department of Epidemiology, University of Washington, Seattle, WA, USA; 6Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, Seattle, WA, USA; 7Departments of Radiology, Neurological Surgery, and Health Services, University of Washington, Seattle, WA, USA; 8Department of Twin Research and Genetic Epidemiology, Kings College London, London, UK; 9Departments of Medicine (Medical Genetics) and Genome Sciences, University of Washington, Seattle, WA, USA BACKGROUND CONTEXT: Inconsistent associations between modifiable risk factors and chronic back pain (CBP) may be due to the inability

of traditional epidemiologic study designs to properly account for an array of potential genetic and environmental confounding factors. The co-twin control research design, comparing modifiable risk factors in twins discordant for CBP, offers a unique way to remove numerous confounding factors. PURPOSE: To examine the association of modifiable lifestyle and psychological factors with lifetime CBP. STUDY DESIGN/SETTING: Cross-sectional co-twin control study in a nationwide sample of male twin members of the Vietnam Era Twin Registry. PATIENT SAMPLE: A total of 7,108 participants including 1,308 monozygotic (MZ) pairs and 793 dizygotic pairs. OUTCOME MEASURE: Self-reported lifetime history of CBP. METHODS: Lifestyle factors included body mass index (BMI), smoking history, alcohol consumption, habitual physical activity, and typical sleep duration. Psychological factors included depression (Patient Health Questionnaire-9 [PHQ9]) and post-traumatic stress disorder (PTSD) symptoms (PTSD Checklist [PCL]). Covariates included age, race, education, and income. Odds ratios (ORs) and 95% confidence intervals (CI) were estimated for the association of risk factors with lifetime CBP when considering twins as individuals, and a within-pair co-twin control analysis that accounted for familial and genetic factors. Funding was through VA grant 5IK2RX001515; there were no study-specific conflicts of interest. RESULTS: The mean age of respondents was 62 years and the prevalence of lifetime CBP was 28%. All lifestyle factors were associated with CBP in the individual level analysis. However, none of these persisted in the withinpair analyses, except for severe obesity (BMI≥35.0) which was associated with lifetime CBP in both individual-level (OR=1.6, 95% CI 1.3–1.9) and within-pair analyses (MZ analysis: OR=3.7, 95% CI 1.2–11.4). PTSD and depression symptoms were strongly associated with lifetime CBP in both the individual-level (moderate/severe depression: OR=4.2, 95% CI 3.6–4.9 and severe PTSD: OR=4.8, 95% CI 4.0–5.7) and within-pair (MZ) analyses (moderate/severe depression: OR=4.6, 95% CI 2.4–8.7 and severe PTSD: OR=3.2, 95% CI 1.6–6.5). CONCLUSIONS: Many associations between modifiable lifestyle risk factors and chronic back pain are due to confounding by familial and genetic factors. Severe obesity, depression, and PTSD should be considered in the development of intervention strategies to reduce the prevalence of chronic back pain. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. http://dx.doi.org/10.1016/j.spinee.2016.09.002

Outstanding Paper: Value in Spine Care Surgery for Degenerative Cervical Myelopathy: A Patient-Centered Quality of Life and Health Economic Evaluation Christopher D. Witiw, MD1,2, Lindsay A. Tetreault, PhD3, Fabrice Smieliauskas, PhD2, Branko Kopjar, MD, PhD4, Eric Massicotte, MD, MSc1, Michael G. Fehlings, MD, PhD1,5,6; 1Division of Neurosurgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada; 2Department of Public Health Sciences, University of Chicago, Chicago, IL, USA; 3Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada; 4Department of Health Services, University of Washington, Seattle, Washington, USA; 5Spinal Program, McEwen Centre for Regenerative Medicine, Toronto Western Hospital, University Health Network, Toronto, Ontario, Canada; 6Department of Surgery, Neural Repair and Regeneration, Spinal Program, University of Toronto, Toronto, Ontario, Canada BACKGROUND CONTEXT: Degenerative cervical myelopathy (DCM) represents the most common cause of nontraumatic spinal cord impairment in adults. Surgery has been shown to improve neurological symptoms and functional status, but it is costly. As sustainability concerns in the field of health care rise, the value of care has come to the forefront of policy decision-making. Evidence for both health related quality of life outcomes and financial expenditures are needed to inform resource allocation decisions.

Refer to onsite annual meeting presentations and postmeeting proceedings for possible referenced figures and tables. Authors are responsible for accurately reporting disclosure and FDA device/drug status at time of abstract submission.