Browsing by Author "Leininger, Brent"
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Item Cost-effectiveness of spinal manipulation therapy for neck or back pain(2023-01) Leininger, BrentChronic pain is a major public health problem, affecting more adults in the United States than heart disease, diabetes, and cancer combined. Low back and neck pain are the most common chronic pain conditions and are two of the most disabling and costly conditions in the U.S. Approximately 4% of all healthcare spending in the U.S. is directed towards the management of back and neck pain, more than any other condition. Spine pain management has gathered increased scrutiny amidst concerns about overutilization of costly and potentially harmful interventions such as opioids, injections, and surgeries. Complementary and integrative interventions may reduce the clinical and cost burden of spine pain and are now recommended by clinical guidelines, but their use remains limited.This dissertation addresses the cost-effectiveness of spinal manipulation therapy and other complementary and integrative therapies for neck or back pain. First, we used individual patient data from eight randomized trials to conduct standardized cost-effectiveness analyses of spinal manipulation therapy (SMT), one of the most common complementary and integrative interventions, compared to home exercise or supervised exercise approaches. We found the cost-effectiveness of SMT varied by population and comparison. When compared to or added to home exercise, cost-effectiveness findings were favorable for acute neck pain, chronic neck pain in older adults, and chronic back-related leg pain; however, SMT was not likely cost-effective for chronic back pain. When compared to or added to supervised exercise, cost-effectiveness findings were favorable for chronic back pain in multiple age groups (adolescents, adults, older adults) and older adults with chronic neck pain. For adults with chronic neck pain, findings were mixed where SMT was not likely cost-effective relative to supervised exercise, but maybe cost-effective when added to supervised exercise. Next, we assessed the generalizability of the randomized clinical trial populations by comparing socio-demographic characteristics and clinical features to representative samples of US adults with chronic spine pain using data from the National Health Interview and Medical Expenditure Panel Surveys. We found the clinical trials had an under-representation of individuals from underserved communities with lower percentages of racial and ethnic minorities, less educated, and unemployed adults relative to the U.S. population with spine pain. While the odds of chiropractic use in the U.S. were lower for individuals from underserved communities, the trial populations also under-represented these populations relative to U.S. adults with chronic spine pain who visit a chiropractor. Finally, we estimated the cost-effectiveness of spinal manipulation and other complementary and integrative approaches for spine pain using a decision analysis model incorporating multiple sources of evidence. We found that yoga resulted in the lowest costs and largest health benefits relative to all other treatments across multiple populations. Other complementary and integrative approaches such as massage, mindfulness-based stress reduction, cognitive behavioral therapy, and SMT were also shown to be cost-effective options relative to home exercise and advice for chronic spine pain across different populations. Findings for these treatments were not sensitive to changes in key model parameters impacting costs or effectiveness. In summary, our work contributes to the understanding of the cost-effectiveness of complementary and integrative approaches including spinal manipulation in U.S. healthcare settings. We used both clinical trial-based and decision model analyses to assess cost-effectiveness and found general consistency of findings across the two approaches. There is a need to better understand the impact of these approaches in populations most severely impacted who are often under-represented in clinical trials.Item Measurement properties of quality-adjusted life year (QALY) measures among older adults with chronic neck pain(2016-04) Leininger, BrentBackground Quality-adjusted life year (QALY) measures are an important outcome for assessing the cost-effectiveness of healthcare interventions. Ideally, the choice of QALY measures will be informed by the measurement properties within the population of interest. Currently, the EQ-5D and SF-6D are the most commonly used QALY measures within cost-effectiveness analyses for spine pain. A number of studies have assessed the measurement properties of QALY measures for individuals with spine pain, but primarily within surgical populations. The psychometric properties of QALY measures may vary substantially within non-surgical populations. The primary aim of this thesis is to assess the psychometric properties (reliability, validity, and responsiveness) of commonly used QALY measures (SF-6D, EQ-5D, EQ Visual Analog Scale) among older U.S. adults with chronic mechanical neck pain managed non-surgically. The secondary aim of the thesis is to assess differences in the psychometric properties of QALY measures derived from the same instrument (SF-6D), but using different valuation methods. Methods Data for the study was collected within a randomized clinical trial comparing different combinations of non-invasive interventions (home exercise and advice, supervised exercise therapy, spinal manipulation) for the management of chronic neck pain in older adults. Quality-adjusted life years (QALYs) were measured with the 1) SF-6D, 2) EQ-5D, and 3) Euroqol visual analogue scale (EQ VAS) using U.S. population values for the primary aim. Test-retest reliability was determined using intraclass correlation coefficients (ICCs). The Bland-Altman method for limits of agreement and the smallest detectable change (SDC) were used to assess agreement. The longitudinal known-group validity and responsiveness of QALY measures was estimated using four external criteria: 1) global perceived change in health; 2) global improvement in neck symptoms; 3) neck pain; and 4) neck disability. Known-group validity was assessed by calculating mean QALY changes for each category of global perceived change in health and neck symptoms in addition to quintiles of neck pain and disability improvement. The relative responsiveness of QALY changes was estimated using correlation and area under the receiver operating characteristic (ROC) curve analyses. Results The SF-6D demonstrated better test-retest reliability (ICC = 0.81; 95% CI 0.77 to 0.85) relative to the EQ-5D (ICC = 0.44; 95% CI 0.33 to 0.53) and EQ VAS (ICC = 0.68; 95% CI 0.61 to 0.75). In addition, the smallest detectable change was lowest for the SF-6D (0.16; 95% CI 0.14 to 0.17), followed by the EQ-5D (0.18; 95% CI 0.16 to 0.20), and EQ VAS (0.22; 95% CI 0.20 to 0.25). Differences in QALYs during the one-week baseline period were evenly spread over the range of mean QALYs for the SF-6D, but not the EQ-5D or EQ VAS. The SF-6D and EQ VAS demonstrated better longitudinal known-group validity relative to the EQ-5D. Mean SF-6D and EQ VAS QALY changes were monotonically decreasing across levels of improvement for three of the four external criteria. All three QALY measures demonstrated similar responsiveness to change. Correlations between QALY measures and three of the external criteria were similar and very low to low in strength (-0.233 to -0.391). Correlations with neck disability were low to moderate in strength with the SF-6D demonstrating the strongest association (-0.596; p-values for differences with EQ-5D and EQ VAS = 0.01). There were no significant differences among the QALY measures when measuring responsiveness with area under the ROC curve. SF-6D based QALY measures had similar reliability, agreement, validity, and responsiveness. Conclusions There were minor differences between U.S. QALY measures in terms of responsiveness; however, the SF-6D was more reliable and demonstrated less measurement error relative to the EQ-5D and EQ VAS, in addition to better known-group validity relative to the EQ-5D. The different methods for obtaining QALY values from the same instrument (SF-6D) had little to no impact on the psychometric properties.