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      Cost-effectiveness of using a motion-sensor biofeedback treatment approach for the management of sub-acute or chronic low back pain: economic evaluation alongside a randomised trial

      research-article
      ,
      BMC Musculoskeletal Disorders
      BioMed Central
      Low back pain, Economic evaluation, Cost-effectiveness, Randomized trial

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          Abstract

          Background

          Low back pain is a common and costly condition internationally. There is high need to identify effective and economically efficient means for managing this problem. This study aimed to explore the cost-effectiveness of a novel motion-sensor biofeedback treatment approach in addition to guidelines-based care compared to guidelines-based care alone, from a societal perspective over a 12 month time horizon.

          Method

          This was an incremental cost-effectiveness analysis conducted concurrently with a pilot, cluster randomized controlled trial. Health care resource use was collected using daily diaries and patient-self report at 3, 6 and 12 month follow-up assessments. Productivity was measured using industry classifications and participant self-reporting of ability to do their normal work with their present pain. Clinical effect was measured using the Patient Global Impression of Change measured at the 12 month follow-up assessment. Data were compared between groups using linear regression clustered by recruitment site. Bootstrap resampling was used to generate a visual representation of the 95% confidence interval for the incremental cost-effectiveness estimate. Two, one-way sensitivity analyses were undertaken to examine the robustness of findings to key assumptions.

          Result

          There were n = 38 participants in the intervention group who completed the 12 month assessment and n = 45 in the control. The intervention group had greater use of trial-related medical and therapy resources [$477 per participant (95% CI: $447, $508)], but lower use of non-trial medical and therapy resources [$-53 per participant (95% CI: $-105, $-0)], and a greater improvement in productivity [$-5123 per participant (95% CI: $-10,174, $-72)]. Overall, the intervention dominated with a saving of $478,100 and an additional 41 participants self-rating as being very or much improved compared to the control. There was >99% confidence in this finding of dominance in both the primary and sensitivity analyses.

          Conclusions

          The motion-sensor biofeedback treatment approach in addition to guidelines- based care appears to be both more clinically effective and economically efficient than guidelines- based care alone. This approach appears to be a viable means to manage low back pain and further research in this area should be a priority.

          Trial registration

          The randomised trial this research was based upon was prospectively registered on March 25th 2009 with the Australian New Zealand Clinical Trials Registry: ACTRN12609000157279.

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          Most cited references20

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          An Introduction to the Bootstrap

          Statistics is a subject of many uses and surprisingly few effective practitioners. The traditional road to statistical knowledge is blocked, for most, by a formidable wall of mathematics. The approach in An Introduction to the Bootstrap avoids that wall. It arms scientists and engineers, as well as statisticians, with the computational techniques they need to analyze and understand complicated data sets.
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            Clinimetric testing of three self-report outcome measures for low back pain patients in Brazil: which one is the best?

            Translation, cross-cultural adaptation, and clinimetric testing of self-report outcome measures. The aims of this investigation were to perform the translation and cross-cultural adaptation of the Patient-Specific Functional Scale (PSFS) into Brazilian-Portuguese and to perform a head-to-head comparison of the clinimetric properties of the Brazilian-Portuguese versions of the PSFS, the Roland-Morris Disability Questionnaire (RMDQ) and the Functional Rating Index (FRI). To date, there is no Brazilian-Portuguese version of the PSFS available and no head-to-head comparison of the Brazilian-Portuguese versions of the PSFS, RMDQ, and FRI has been undertaken. The PSFS was translated and adapted into Brazilian-Portuguese. The PSFS, the RMDQ, and the FRI were administered to 99 patients with low back pain to evaluate internal consistency, reproducibility, ceiling and floor effects, construct validity, internal and external responsiveness. To fully test the construct validity and external responsiveness of these measures, it was necessary to cross-culturally adapt the Pain Numerical Rating Scale and the Global Perceived Effect Scale. All measures demonstrated high levels of internal consistency (Cronbach's alpha range = 0.88-0.90) and reproducibility (Intraclass Correlation Coefficient 2,1 range = 0.85-0.94). High correlations among the disability-related measures were observed (Pearson's r ranging from 0.51 to 0.71). No ceiling or floor effects were detected. The PSFS was consistently more responsive than the other measures in both the internal responsiveness and external responsiveness analyses. The results from this study demonstrate that the Brazilian-Portuguese versions of the RMDQ, the FRI and the PSFS have similar clinimetric properties to each other and to the original English versions. Of allthe measures tested in this study the PSFS seems the most responsive. These measures will enable international comparisons to be performed, and encourage researchers to include Portuguese speakers in their clinical trials.
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              On The So-Called “Huber Sandwich Estimator” and “Robust Standard Errors”

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                Author and article information

                Contributors
                Terrence.haines@monash.edu
                Kelly-ann.bowles@monash.edu
                Journal
                BMC Musculoskelet Disord
                BMC Musculoskelet Disord
                BMC Musculoskeletal Disorders
                BioMed Central (London )
                1471-2474
                17 January 2017
                17 January 2017
                2017
                : 18
                : 18
                Affiliations
                Allied Health Research Unit & Physiotherapy Department, School of Primary Health Care, Monash University and Monash Health, Kingston Rd, Cheltenham, 3192 Australia
                Author information
                http://orcid.org/0000-0003-3150-6154
                Article
                1371
                10.1186/s12891-016-1371-6
                5240200
                28095832
                9b649b51-75d5-4ba4-a5d1-f605965b3f9d
                © The Author(s). 2017

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 10 June 2016
                : 19 December 2016
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100002325, Department of State Development, Business and Innovation, Government of Victoria;
                Award ID: Not applicable
                Funded by: DorsaVi Pty Ltd
                Award ID: Not Applicable
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2017

                Orthopedics
                low back pain,economic evaluation,cost-effectiveness,randomized trial
                Orthopedics
                low back pain, economic evaluation, cost-effectiveness, randomized trial

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