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Are Nonpharmacologic Interventions for Chronic Low Back Pain More Cost Effective Than Usual Care? Proof of Concept Results From a Markov Model.

ABSTRACT: STUDY DESIGN:Markov model. OBJECTIVE:Examine the 1-year effectiveness and cost-effectiveness (societal and payer perspectives) of adding nonpharmacologic interventions for chronic low back pain (CLBP) to usual care using a decision analytic model-based approach. SUMMARY OF BACKGROUND DATA:Treatment guidelines now recommend many safe and effective nonpharmacologic interventions for CLBP. However, little is known regarding their effectiveness in subpopulations (e.g., high-impact chronic pain patients), nor about their cost-effectiveness. METHODS:The model included four health states: high-impact chronic pain (substantial activity limitations); no pain; and two others without activity limitations, but with higher (moderate-impact) or lower (low-impact) pain. We estimated intervention-specific transition probabilities for these health states using individual patient-level data from 10 large randomized trials covering 17 nonpharmacologic therapies. The model was run for nine 6-week cycles to approximate a 1-year time horizon. Quality-adjusted life-year weights were based on six-dimensional health state short form scores; healthcare costs were based on 2003 to 2015 Medical Expenditure Panel Survey data; and lost productivity costs used in the societal perspective were based on reported absenteeism. Results were generated for two target populations: (1) a typical baseline mix of patients with CLBP (25% low-impact, 35% moderate-impact, and 40% high-impact chronic pain) and (2) high-impact chronic pain patients. RESULTS:From the societal perspective, all but two of the therapies were cost effective (<$50,000/quality-adjusted life-year) for a typical patient mix and most were cost saving. From the payer perspective fewer were cost saving, but the same number was cost-effective. Assuming all patients in the model have high-impact chronic pain increases the effectiveness and cost-effectiveness of most, but not all, therapies indicating that substantial benefits are possible in this subpopulation. CONCLUSION:Modeling leverages the evidence produced from clinical trials to provide more information than is available in the published studies. We recommend modeling for all existing studies of nonpharmacologic interventions for CLBP. LEVEL OF EVIDENCE:4.

SUBMITTER: Herman PM

PROVIDER: S-EPMC6779140 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Are Nonpharmacologic Interventions for Chronic Low Back Pain More Cost Effective Than Usual Care? Proof of Concept Results From a Markov Model.

Herman Patricia M PM Lavelle Tara A TA Sorbero Melony E ME Hurwitz Eric L EL Coulter Ian D ID

Spine 20191001 20

<h4>Study design</h4>Markov model.<h4>Objective</h4>Examine the 1-year effectiveness and cost-effectiveness (societal and payer perspectives) of adding nonpharmacologic interventions for chronic low back pain (CLBP) to usual care using a decision analytic model-based approach.<h4>Summary of background data</h4>Treatment guidelines now recommend many safe and effective nonpharmacologic interventions for CLBP. However, little is known regarding their effectiveness in subpopulations (e.g., high-imp ...[more]

PMID: 31095119

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Project description:Study designMarkov model.ObjectiveFurther validity test of a previously published model.Summary of background dataThe previous model was built using data from ten randomized trials and examined the 1-year effectiveness and cost-effectiveness of 17 nonpharmacologic interventions for chronic low back pain (CLBP), each compared to usual care alone. This update incorporated data from five additional trials.MethodsBased on transition probabilities that were estimated using patient-level trial data, a hypothetical cohort of CLBP patients transitioned over time among four defined health states: high-impact chronic pain with substantial activity limitations; higher (moderate-impact) and lower (low-impact) pain without activity limitations; and no pain. As patients transitioned among health states, they accumulated quality-adjusted life-years, as well as healthcare and productivity costs. Costs and effects were calculated incremental to each study's version of usual care.ResultsFrom the societal perspective and assuming a typical patient mix (25% low-impact, 35% moderate-impact, and 40% high-impact chronic pain), most interventions-including those newly added-were cost-effective (<$50,000/QALY) and demonstrated cost savings. From the payer perspective, fewer were cost-saving, but the same number were cost-effective. Results for the new studies generally mirrored others using the same interventions-for example, cognitive behavioral therapy (CBT) and physical therapy. A new acupuncture study had similar effectiveness to other acupuncture studies, but higher usual care costs, resulting in higher cost savings. Two new yoga studies' results were similar, but both differed from those of the original yoga study. Mindfulness-based stress reduction was similar to CBT for a typical patient mix but was twice as effective for those with high-impact chronic pain.ConclusionMarkov modeling facilitates comparisons across interventions not directly compared in trials, using consistent outcome measures after balancing the baseline mix of patients. Outcomes also differed by pain impact level, emphasizing the need to measure CLBP subgroups.Level of evidenceN/A.

Project description:BackgroundThe effects of improvement (implementation and de-implementation) interventions are often modest. Although positive and negative deviance studies have been extensively used in improvement science and quality improvement efforts, conceptual and methodological innovations are needed to improve our ability to use information about variation in quality to design more effective interventions.ObjectiveWe describe a novel mixed methods extension of the deviance study we term "delta studies." Delta studies seek to quantitatively identify sites that have recently changed from low performers to high performers, or vice versa, in order to qualitatively learn about active strategies that produced recent change, challenges change agents faced and how they overcame them, and where applicable, the causes of recent deterioration in performance-information intended to inform the design of improvement interventions for deployment in low performing sites. We provide examples of lessons learned from this method that may have been missed with traditional positive or negative deviance designs.DesignConsiderations for quantitatively identifying delta sites are described including which quality metrics to track, over what timeframe to observe change, how to account for reliability of observed change, consideration of patient volume and initial performance as implementation context factors, and how to define clinically meaningful change. Methods to adapt qualitative protocols by integrating quantitative information about change in performance are also presented. We provide sample data and R code that can be used to graphically display distributions of initial status, change, and volume that are essential to delta studies.ParticipantsPatients and facilities of the US Veterans Health Administration.Key resultsAs an example, we discuss what decisions we made regarding the delta study design considerations in a funded study of low-value preoperative testing. The method helped us find sites that had recently reduced the burden of low-value testing, and learn about the strategies they employed and challenges they faced.ConclusionsThe delta study concept is a promising mixed methods innovation to efficiently and effectively identify improvement strategies and other factors that have actually produced change in real-world settings.

Project description:BackgroundPreventing transition to chronic back pain (CBP) is a long-sought strategy that could rescue patients from prolonged suffering. Recent rodent and human brain imaging studies suggest involvement of sexually dimorphic, dopaminergic-motivational, mesolimbic circuits in the transition to chronic pain (tCBP), and hint that the combination of carbidopa/levodopa and naproxen (LDP + NPX) may block tCBP. Here we evaluated, in people with recent-onset back pain, whether a 3-month treatment with LDP + NPX is safe, blocks tCBP, and whether its efficacy is sex-dependent.MethodsA total of 72 participants were enrolled and stratified by risk for tCBP using brain-imaging biomarkers. Low-risk participants entered a no-treatment arm. Others were randomized to placebo + naproxen or LDP + NPX for 3 months.ResultsBoth treatments resulted in more than 50% pain relief for approximately 75% of participants. A strong sex by treatment interaction was observed for daily pain intensity (phone NRS, P = 0.007), replicated on 4-week average pain (Pain/4w, P = 0.00001), and in intent-to-treat analysis (Pain/4w, P = 0.000004). Nucleus accumbens functional connectivity with medial prefrontal cortex, a predefined objective biomarker, showed sex dependence at baseline (P = 0.03) and sex-by-treatment interaction effect 3 months after treatment cessation (P = 0.031). Treatment modified the psychological profile of participants, and disrupted brain modeling-based predicted back pain intensity trajectories. Forty participants were queried 3.3 years from trial start; back pain ratings were similar between end of treatment and at 3.3 years (P = 0.62), indicating persistence of relief for this duration.ConclusionsThese results provide the first evidence for preventing transition to chronic back pain using sex-specific pharmacotherapy. These provocative observations require confirmation in a larger study. ClinicalTrials.gov identifier: NCT01951105.

Project description:BackgroundLifestyle interventions affect patients' risk factors for metabolic syndrome (MeSy), a pre-stage to cardiovascular diseases, diabetes and related complications. An effective lifestyle intervention is the Swedish Björknäs intervention, a 3-year randomized controlled trial in primary care for MeSy patients. To include future disease-related cost and health consequences in a cost-effectiveness analysis, a simulation model was used to estimate the short-term (3-year) and long-term (lifelong) cost-effectiveness of the Björknäs study.Methodology/ principal findingsA Markov micro-simulation model was used to predict the cost and quality-adjusted life years (QALYs) for MeSy-related diseases based on ten risk factors. Model inputs were levels of individual risk factors at baseline and at the third year. The model estimated short-term and long-term costs and QALYs for the intervention and control groups. The cost-effectiveness of the intervention was assessed using differences-in-differences approach to compare the changes between the groups in the health care and societal perspectives, using a 3% discount rate. A 95% confidence interval (CI), based on bootstrapping, and sensitivity analyses describe the uncertainty in the estimates. In the short-term, costs are predicted to increase over time in both groups, but less in the intervention group, resulting in an average cost saving/reduction of US$-700 (in 2012, US$1=six point five seven SEK) and US$-500, in the societal and health care perspectives. The long-term estimate also predicts increased costs, but considerably less in the intervention group: US$-7,300 (95% CI: US$-19,700 to US$-1,000) in the societal, and US$-1,500 (95% CI: US$-5,400 to US$2,650) in the health care perspective. As intervention costs were US$211 per participant, the intervention would result in cost saving. Furthermore, in the long-term an estimated 0.46 QALYs (95% CI: 0.12 to 0.69) per participant would be gained.Conclusions/ significanceThe Swedish Björknäs study appears to reduce demands on societal and health care resources and increase health-related quality of life.

Project description:BackgroundThe collaborative treatment of acupuncture in addition to routine care as an approach for the management of low back pain (LBP) is receiving increasing recognition from both public and professional arenas. In 2010, the Ministry of Health, Welfare and Family Affairs (MOHW) of South Korea approved the practice of doctors and Oriental medical doctors (acupuncture qualified) working together in the same facility and offering collaborative treatment at the same time for the same disease. However, there is little more than anecdotal evidence on the health and economic implications of this current practice. Therefore, the objective of this study is to examine the effectiveness and costs of acupuncture in addition to routine care in the treatment of chronic LBP patients in South Korea.MethodsThe Markov model was developed to synthesise evidence on both costs and outcomes for patients with chronic LBP. We conducted the base case analysis, univariate and probabilistic sensitivity analyses, and also performed the value of information analysis for future researches. Model parameters were sourced from systematic review of both alternatives, simple bibliographic reviews of relevant articles published in English or Korean, and statistical analyses of the 2005 and 2007 Korean National Health and Nutrition Survey (KNHNS) data. The analyses were based on the societal perspective over a five year time horizon using a 5% discount rate.ResultsIn the base case, collaborative treatment resulted in better outcomes, but at a relatively high cost. Overall, the incremental cost-effectiveness ratio of a collaborative practice was 3,421,394 KRW (Korean rate Won) per QALY (Quality adjusted life year) (2,895.80 USD per QALY). Univariate sensitivity analysis of indirect non-medical costs did not affect the preference order of the strategies. Probabilistic sensitivity analysis revealed that if the threshold was over 3,260,000 KRW per QALY (2,759.20 USD per QALY), the probability for cost-effectiveness of a collaborative practice would exceed 50%. At 20,000,000 KRW per QALY, which is recommended using per capita gross domestic product (GDP) as the threshold, the probability would be 72.3%.ConclusionsOn the basis of our findings, acupuncture collaborative therapy for patients with chronic LBP may be cost-effective if the usual threshold is applied. Further empirical studies are required to overcome the limitations of uncertainties and improve the precision of the results.

Project description:As complex and heterogeneous diseases, cancers require a more tailored therapeutic management than most pathologies. Recent advances in anticancer drug development, including the immuno-oncology revolution, have been too often plagued by unsatisfying patient response rates and survivals. In reaction to this, cancer care has fully transitioned to the "personalized medicine" concept. Numerous tools are now available tools to better adapt treatments to the profile of each patient. They encompass a large array of diagnostic assays, based on biomarkers relevant to targetable molecular pathways. As a subfamily of such so-called companion diagnostics, chemosensitivity and resistance assays represent an attractive, yet insufficiently understood, approach to individualize treatments. They rely on the assessment of a composite biomarker, the ex vivo functional response of cancer cells to drugs, to predict a patient's outcome. Systemic treatments, such as chemotherapies, as well as targeted treatments, whose efficacy cannot be fully predicted yet by other diagnostic tests, may be assessed through these means. The results can provide helpful information to assist clinicians in their decision-making process. We explore here the most advanced functional assays across oncology indications, with an emphasis on tests already displaying a convincing clinical demonstration. We then recapitulate the main technical obstacles faced by researchers and clinicians to produce more accurate, and thus more predictive, models and the recent advances that have been developed to circumvent them. Finally, we summarize the regulatory and quality frameworks surrounding functional assays to ensure their safe and performant clinical implementation. Functional assays are valuable in vitro diagnostic tools that already stand beyond the "proof-of-concept" stage. Clinical studies show they have a major role to play by themselves but also in conjunction with molecular diagnostics. They now need a final lift to fully integrate the common armament used against cancers, and thus make their way into the clinical routine.

Project description:ImportanceA key question for policy makers and the public is what to expect from the COVID-19 pandemic going forward as states lift nonpharmacologic interventions (NPIs), such as indoor mask mandates, to prevent COVID-19 transmission.ObjectiveTo project COVID-19 deaths between March 1, 2022, and December 31, 2022, in each of the 50 US states, District of Columbia, and Puerto Rico assuming different dates of lifting of mask mandates and NPIs.Design setting and participantsThis simulation modeling study used the COVID-19 Policy Simulator compartmental model to project COVID-19 deaths from March 1, 2022, to December 31, 2022, using simulated populations in the 50 US states, District of Columbia, and Puerto Rico. Projected current epidemiologic trends for each state until December 31, 2022, assuming the current pace of vaccination is maintained into the future and modeling different dates of lifting NPIs.ExposuresDate of lifting statewide NPI mandates as March 1, April 1, May 1, June 1, or July 1, 2022.Main outcomes and measuresProjected COVID-19 incident deaths from March to December 2022.ResultsWith the high transmissibility of current circulating SARS-CoV-2 variants, the simulated lifting of NPIs in March 2022 was associated with resurgences of COVID-19 deaths in nearly every state. In comparison, delaying by even 1 month to lift NPIs in April 2022 was estimated to mitigate the amplitude of the surge. For most states, however, no amount of delay was estimated to be sufficient to prevent a surge in deaths completely. The primary factor associated with recurrent epidemics in the simulation was the assumed high effective reproduction number of unmitigated viral transmission. With a lower level of transmissibility similar to those of the ancestral strains, the model estimated that most states could remove NPIs in March 2022 and likely not see recurrent surges.Conclusions and relevanceThis simulation study estimated that the SARS-CoV-2 virus would likely continue to take a major toll in the US, even as cases continued to decrease. Because of the high transmissibility of the recent Delta and Omicron variants, premature lifting of NPIs could pose a substantial threat of rebounding surges in morbidity and mortality. At the same time, continued delay in lifting NPIs may not prevent future surges.

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Are Nonpharmacologic Interventions for Chronic Low Back Pain More Cost Effective Than Usual Care? Proof of Concept Results From a Markov Model.

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Are Nonpharmacologic Interventions for Chronic Low Back Pain More Cost Effective Than Usual Care? Proof of Concept Results From a Markov Model.

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