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      Does the severity of pain correlate with severity of functional disability? Factors influencing ‘patient reported outcome measures’ in spinal patients

      research-article
      1 , * , 2
      SICOT-J
      EDP Sciences
      Patient reported outcome measures, PROMs, Oswestry disability index, VAS pain score, Lumbar spinal surgery

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          Abstract

          Aims: To assess correlation between the Visual Analogue Scale (VAS) pain score and the Oswestry Disability Index (ODI) and which patient factors can influence patient-reported outcome measures (PROMs). This study also aims to assess the response to the sexual function question of the ODI.

          Methods: Retrospective analysis of 200 consecutive patients undergoing a range of different lumbar spinal procedures between July 2012 and September 2015 was performed. Subgroup analysis was also performed on the 122 patients who underwent microdiscectomy and/or decompression procedures only. Data from notes and clinical letters from the patient's first clinic appointment were collected. In addition to these outcome measures, data were also extracted regarding patients' gender, age, smoking status, alcohol use, employment and mental health status.

          Results: Significant correlation was found between VAS pain score and ODI ( p = 0.002) and between VAS pain score and question 1 of ODI ( p = 0.0001). A lower ODI score was reported at time of surgery by those in employment compared to those who are unemployed ( p = 0.008). In addition to this, a lower ODI score was reported in those who are self-employed compared to those in employment ( p = 0.048) in both cohorts. A significantly higher mean ODI score was shown within the subgroup analysis for current smokers ( p = 0.02). None of the other patient factors that were analysed were found to affect PROMs. 65% of patients answered the sexual function question of the ODI.

          Conclusions: Significant correlation was demonstrated between VAS pain score and ODI. Those who are in employment are far more likely to report a lower ODI score than those who are unemployed at the time of surgery. Self-employed patients were found to have reported a significantly lower ODI score than those who are in employment. Smoking cessation should be encouraged as those who are current smokers may be more likely to report a higher ODI. As 65% of patients decided to answer the sexual function question of the ODI, this supports its further use.

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          Most cited references14

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          Absence from work and return to work in people with back pain: a systematic review and meta-analysis

          Background A considerable proportion of work absence is attributed to back pain, however prospective studies in working populations with back pain are variable in setting and design, and a quantitative summary of current evidence is lacking. Objective To investigate the extent to which differences in setting, country, sampling procedures and methods for data collection are responsible for variation in estimates of work absence and return to work. Methods Systematic searches of seven bibliographic databases. Inclusion criteria were: adults in paid employment, with back pain, work absence or return to work during follow-up had been reported. Random effects meta-analysis and meta-regression analysis was carried out to provide summary estimates of work absence and return to work rates. Results 45 studies were identified for inclusion in the review; 34 were included in the meta-analysis. The pooled estimate for the occurrence of work absence in workers with back pain was 15.5% (95% CI 9.8% to 23.6%, n=17 studies, I2 98.1%) in studies with follow-up periods of ≤6 months. The pooled estimate for the proportion of people with back pain returning to work was 68.2% (95% CI 54.8% to 79.1%, n=13, I2 99.2%), 85.6% (95% CI 78.2% to 90.7%, n=13, I2 98.7%) and 93.3% (95% CI 84.0% to 94.7%, n=10, I2 99%), at 1 month, 1–6 months and ≥6 months, respectively. Differences in setting, risk of participation bias and method of assessing work absence explained some of the heterogeneity. Conclusions Pooled estimates suggest high return to work rates, with wide variation in estimates of return to work only partly explained by a priori defined study-level variables. The estimated 32% not back at work at 1 month are at a crucial point for intervention to prevent long term work absence.
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            Evaluating the correlation and responsiveness of patient-reported pain with function and quality-of-life outcomes after spine surgery.

            Systematic review. To determine the correlation of patient-reported pain with physical function and health-related quality of life (HRQoL) after spine surgery and to determine the responsiveness of pain, physical function, and HRQoL after spine surgery. Several validated outcome instruments are available to assess the success of treatment for chronic low back pain. These patient-centered tools include measurements for pain based on numeric scales, validated condition-specific functional outcomes measures, and HRQoL outcomes measures. It is unclear whether these three types of patient-reported outcomes are measuring different constructs and whether all three should be measured after spine surgery. In addition, it is unclear which of these outcomes measures is most sensitive to change after spine surgery for low back pain. A systematic search was conducted in MEDLINE, EMBASE, and the Cochrane Collaboration Library for literature published through December 2010. The correlation between pain (visual analog scale, VAS), physical function (Oswestry Disability Index, ODI), and HRQoL (36-Item Short Form Health Survey [SF-36] and European Quality of Life [EQ-5D]) change scores was performed using the Spearman rank correlation coefficients. To compare the responsiveness of pain, function, and HRQoL scores after spine surgery, we calculated effect sizes by dividing change scores by the SD of the baseline scores. This standardized method allowed us to compare the responsiveness of each outcome measure directly and reported an effect size of 0.2 to 0.3 as a "small" effect, around 0.5 a "medium" effect and 0.8 to infinity, a "large" effect. To determine whether the differences in effect sizes measuring responsiveness were significantly different, we conducted a Wilcoxon signed-rank test between each of the three measurements of pain, function, and HRQoL scores when there was enough data to perform the test. None of the correlations exceeded 0.70 using the Spearman rank correlation coefficients, suggesting that these outcomes are measuring different constructs. The strongest correlations were between the VAS back pain change scores and the SF-36 physical composite score change scores (ρ = 0.67) and VAS back pain change scores and ODI change scores (ρ = 0.69). The pooled mean effect sizes for the five studies that reported a pain measure and the ODI were 1.4 ± 0.57 and 1.1 ± 0.39, respectively. Both are considered "large" effect sizes. The pooled mean effect sizes for the three studies reporting the SF-36 physical and mental composite scores were 0.66 ± 0.39 and 0.54 ± 0.36, respectively. Both are considered "medium" effect sizes. The pooled mean effect sizes for the single studies reporting the EQ-5D and SF-36 total score were 0.78 ± 0.12 and 0.34 ± 0.21. These were "medium" and "small," respectively. We observed little correlation between the change in pain and the change in HRQoL outcomes measures. The strongest correlation was between VAS pain and ODI but was still not considered strong (0.69). These findings suggest that these three outcomes (pain, function, and HRQoL) are measuring different constructs. With respect to responsiveness, VAS pain and ODI were the only outcomes measures that demonstrated a large effect after lumbar spine surgery. None of the HRQoL tools were as sensitive to the treatment. The EQ-5D, SF physical composite, and SF mental composite outcomes demonstrated a medium effect, while the SF-36 total score demonstrated a small effect. The responsive measure shows that the more specific the outcomes tool, the more sensitive the response. Recommendation 1: When surgically treating CLBP, we recommend administering both a VAS for pain and a condition-specific physical measure such as the ODI before and after surgical intervention as these outcomes are the most treatment specific and responsive to change. Strength of recommendation: Strong.Recommendation 2: When evaluating the surgical outcomes for CLBP in the clinical-research setting, we recommend selecting a shorter version for measuring general HRQoL (e.g., SF-12, EQ-5D) to minimize clinician and patient burden. Strength of recommendation: Strong.
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              POLYMAT-C: a comprehensive SPSS program for computing the polychoric correlation matrix.

              We provide a free noncommercial SPSS program that implements procedures for (a) obtaining the polychoric correlation matrix between a set of ordered categorical measures, so that it can be used as input for the SPSS factor analysis (FA) program; (b) testing the null hypothesis of zero population correlation for each element of the matrix by using appropriate simulation procedures; (c) obtaining valid and accurate confidence intervals via bootstrap resampling for those correlations found to be significant; and (d) performing, if necessary, a smoothing procedure that makes the matrix amenable to any FA estimation procedure. For the main purpose (a), the program uses a robust unified procedure that allows four different types of estimates to be obtained at the user's choice. Overall, we hope the program will be a very useful tool for the applied researcher, not only because it provides an appropriate input matrix for FA, but also because it allows the researcher to carefully check the appropriateness of the matrix for this purpose. The SPSS syntax, a short manual, and data files related to this article are available as Supplemental materials that are available for download with this article.
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                Author and article information

                Journal
                SICOT J
                SICOT J
                sicotj
                SICOT-J
                EDP Sciences
                2426-8887
                2018
                1 October 2018
                : 4
                : ( publisher-idID: sicotj/2018/01 )
                : 43
                Affiliations
                [1 ] Plymouth University Peninsula School of Medicine Dentistry, Plymouth UK
                [2 ] Department of Surgery, Plymouth Hospitals NHS Trust, Derriford Hospital, Plymouth PL6 8DH UK
                Author notes
                [* ]Corresponding author: andy_maccormick@ 123456hotmail.co.uk
                Article
                sicotj170137 10.1051/sicotj/2018029
                10.1051/sicotj/2018029
                6166414
                30270822
                14bac2da-4d42-4939-8c53-9aa29d7c8932
                © The Authors, published by EDP Sciences, 2018

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 24 November 2017
                : 15 May 2018
                Page count
                Figures: 6, Tables: 2, Equations: 0, References: 18, Pages: 6
                Categories
                Spine
                Research

                patient reported outcome measures,proms,oswestry disability index,vas pain score,lumbar spinal surgery

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