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      The relationship between pain severity and patient-reported outcomes among patients with chronic low back pain in Japan

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          The aim of this study was to quantify the impact of pain severity on patient-reported outcomes among individuals diagnosed with chronic low back pain in Japan.


          Data were provided by the 2012 Japan National Health and Wellness Survey (N=29,997), a web-based survey of individuals in Japan aged ≥18 years. This analysis included respondents diagnosed with low back pain of ≥3-month duration. Measures included the revised Medical Outcomes Study 36-Item Short-Form Survey Instrument, the Patient Health Questionnaire-9, the Generalized Anxiety Disorder-7 scale, the Work Productivity and Activity Impairment: General Health questionnaire, and self-reported all-cause health care visits (6 months). Generalized linear models were used to assess the relationship between outcomes and severity of pain in the past week as reported on a numeric rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine), controlling for length of diagnosis, sociodemographics, and general health characteristics.


          A total of 290 respondents were included in the analysis; mean age was 56 years, 41% were females, and 56% were employed. Pain severity was 3/10 for the first quartile, 5/10 for the median, and 7/10 for the third quartile of this sample. Increasing severity was associated with lower scores for mental and physical component summaries and Short-Form 6D health utility, higher depression (Patient Health Questionnaire-9) and anxiety (Generalized Anxiety Disorder-7) scores, greater absenteeism and presenteeism, greater activity impairment, and more health care provider visits (all P<0.0001).


          The impact of chronic low back pain on health-related quality of life, depression and anxiety symptoms, impairment to work and daily activities, and health care use increases with the severity of pain. Interventions reducing the severity of pain may improve numerous health outcomes even if the pain cannot be eliminated.

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          Most cited references 19

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          The estimation of a preference-based measure of health from the SF-12.

          The SF-12 is a multidimensional generic measure of health-related quality of life. It has become widely used in clinical trials and routine outcome assessment because of its brevity and psychometric performance, but it cannot be used in economic evaluation in its current form. We sought to derive a preference-based measure of health from the SF-12 for use in economic evaluation and to compare it with the original SF-36 preference-based index. The SF-12 was revised into a 6-dimensional health state classification (SF-6D [SF-12]) based on an item selection process designed to ensure the minimum loss of descriptive information. A sample of 241 states defined by the SF-6D (of 7500) have been valued by a representative sample of 611 members of the UK general population using the standard gamble (SG) technique. Models are estimated of the relationship between the SF-6D (SF-12) and SG values and evaluated in terms of their coefficients, overall fit, and the ability to predict SG values for all health states. The models have produced significant coefficients for levels of the SF-6D (SF-12), which are robust across model specification. The coefficients are similar to those of the SF-36 version and achieve similar levels of fit. There are concerns with some inconsistent estimates and these have been merged to produce the final recommended model. As for the SF-36 model, there is evidence of over prediction of the value of the poorest health states. The SF-12 index provides a useful tool for researchers and policy makers wishing to assess the cost-effectiveness of interventions.
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            Prevalence and characteristics of chronic musculoskeletal pain in Japan

            Background This cross-sectional study was conducted to obtain epidemiologic data on chronic musculoskeletal pain in the Japanese people, and with it a better understanding of the actual conditions and problems involved. Methods A questionnaire covering basic information, chronic musculoskeletal pain, daily life, quality of life, and social loss was prepared and mailed to 11507 individuals aged 18 years or older. Subjects were selected randomly nationwide in accordance with the demographic composition of Japan. Results The prevalence of chronic musculoskeletal pain was 15.4%. The prevalence was highest in people in their 30s to 50s. Pain occurred most frequently in the low back, neck, shoulder, and knee. Among symptomatic subjects, 42% sought treatment, by visiting a medical institution (19%), taking folk remedies (20%), or both (3%). Treatment was generally prolonged, with 70% of those treated reporting treatment durations of more than a year. Although 69% reported that their symptoms had improved, 30% reported unchanged or aggravated symptoms and dissatisfaction with treatment. Among symptomatic subjects, a high percentage of both men and women had lost jobs, left school, been absent from work or school, or had changed jobs. Basic activities of daily living (ADL) were disturbed in men, and the instrumental ADL (IADL) score was low in women. SF-36 scale scores were significantly lower in every area for subjects with chronic pain. Conclusions Chronic musculoskeletal pain does not necessarily improve even with prolonged treatment. It adversely affects daily life and both physical and mental health. Because those suffering pain often increasingly need assistance in daily activities, people around them are also affected. The therapeutic system and treatment procedures for chronic musculoskeletal pain merit prompt review.
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              What is the relationship between the minimally important difference and health state utility values? The case of the SF-6D

              Background The SF-6D is a new single summary preference-based measure of health derived from the SF-36. Empirical work is required to determine what is the smallest change in SF-6D scores that can be regarded as important and meaningful for health professionals, patients and other stakeholders. Objectives To use anchor-based methods to determine the minimally important difference (MID) for the SF-6D for various datasets. Methods All responders to the original SF-36 questionnaire can be assigned an SF-6D score provided the 11 items used in the SF-6D have been completed. The SF-6D can be regarded as a continuous outcome scored on a 0.29 to 1.00 scale, with 1.00 indicating "full health". Anchor-based methods examine the relationship between an health-related quality of life (HRQoL) measure and an independent measure (or anchor) to elucidate the meaning of a particular degree of change. One anchor-based approach uses an estimate of the MID, the difference in the QoL scale corresponding to a self-reported small but important change on a global scale. Patients were followed for a period of time, then asked, using question 2 of the SF-36 as our global rating scale, (which is not part of the SF-6D), if there general health is much better (5), somewhat better (4), stayed the same (3), somewhat worse (2) or much worse (1) compared to the last time they were assessed. We considered patients whose global rating score was 4 or 2 as having experienced some change equivalent to the MID. In patients who reported a worsening of health (global change of 1 or 2) the sign of the change in the SF-6D score was reversed (i.e. multiplied by minus one). The MID was then taken as the mean change on the SF-6D scale of the patients who scored (2 or 4). Results This paper describes the MID for the SF-6D from seven longitudinal studies that had previously used the SF-36. Conclusions From the seven reviewed studies (with nine patient groups) the MID for the SF-6D ranged from 0.010 to 0.048, with a weighted mean estimate of 0.033 (95% CI: 0.029 to 0.037). The corresponding Standardised Response Means (SRMs) ranged from 0.11 to 0.48, with a mean of 0.30 and were mainly in the "small to moderate" range using Cohen's criteria, supporting the MID results. Using the half-standard deviation (of change) approach the mean effect size was 0.051 (range 0.033 to 0.066). Further empirical work is required to see whether or not this holds true for other patient groups and populations.

                Author and article information

                J Pain Res
                J Pain Res
                Journal of Pain Research
                Journal of Pain Research
                Dove Medical Press
                02 June 2016
                : 9
                : 337-344
                [1 ]Eli Lilly Australia Pty Ltd., Sydney, NSW, Australia
                [2 ]Health Outcomes Practice, Kantar Health, Horsham, PA, USA
                [3 ]Health Outcomes Practice, Kantar Health, Princeton, NJ, USA
                [4 ]Eli Lilly Japan K.K., Kobe, Japan
                [5 ]Department of Orthopedic Surgery, Keio University School of Medicine, Tokyo, Japan
                Author notes
                Correspondence: Jeffrey Vietri, Health Outcomes Practice, Kantar Health, 700 Horsham Road, Horsham, PA 19044, USA, Tel +1 908 887 3535, Fax +1 609 987 5514, Email Jeffrey.vietri@ 123456kantarhealth.com
                © 2016 Montgomery et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                Original Research

                Anesthesiology & Pain management

                work impairment, quality of life, chronic pain


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