title: The clinical importance of changes in outcome scores after treatment for chronic low back pain Changes in the SF-36 in 12 months in a clinical sample of disadvantaged older adults. Minimal Clinically Important Change for Pain Intensity, Functional Status, and General Health Status in Patients With Nonspecific Low Back Pain Empirically derived criteria cast doubt on the clinical significance of antidepressant-placebo differences.
abstract: Abstract . When measuring treatment effect in chronic low back pain with multi-item outcome instruments , it is necessary , both for clinical decision-making and research purpose s , to underst and the clinical importance of the outcome scores . The aims of the present study were three-fold . Firstly , it aim ed to estimate the minimal clinical ly important difference of three multi-item outcome instruments ( the Oswestry Disability Index , the General Function Score and the Zung Depression Scale )  and of the  visual analogue scale ( VAS ) of back pain .  Secondly , it aim ed to estimate the error of measurement of these instruments ; and its third aim was to describe the clinical meaning of score change . The study population consisted of 289 patients treated surgically or non-surgically in a r and omised controlled trial . The minimal clinical ly important difference was estimated with patient global assessment as the external criterion . It was compared with the st and ard error of measurement of the instruments . The individual items of the instruments were compared for score changes related to improvement and deterioration . The st and ard error of measurement of the Oswestry Disability Index , the General Function Score and the Zung Depression Scale was 4 , 6 and 3 units , respectively . The 95 % tolerance interval was 10 , 16 and 8 units , respectively . The minimal clinical ly important difference was 10 , 12 and 8–9 units , respectively , thus not significantly exceeding the tolerance interval . The minimal clinical ly important difference of VAS back pain was 18–19 units , well exceeding the 95 % tolerance interval , which was 15 units . Improvement after treatment for chronic low back pain tends to occur to a greater extent in sleep disturbance , ability to do usual things and psychological irritability , but to a lesser extent in the ability to sit , st and and lift . We conclude that the VAS of back pain is responsive enough to detect the minimal clinical ly important difference , whereas the smallest acceptable score changes of the Oswestry Disability Index , the General Function Score and the Zung Depression Scale may require an increase to exceed the 95 % tolerance interval when used for clinical decision making and for power calculation . Despite improvement after treatment , the ability to sit , st and and lift , remain notable problems OBJECTIVES The present study assessed changes in the Medical Outcomes Study 36-item short-form health survey ( SF-36 )  during a 12-month period and examined the relation of those changes to selected baseline characteristics . METHODS The study was a 12-month follow-up evaluation of 786 disadvantaged adults aged 50 to 99 years old who had participated in a r and omized controlled clinical trial in the general medicine outpatient clinics of a major academic medical center . Descriptive and psychometric analyses of changes in the SF-36 scale scores during a 12-month period were performed , and two series of multivariable logistic regressions of increases or decreases greater than one st and ard error of measurement ( SEM ) versus stability on selected baseline characteristics were done . Measures were the eight SF-36 scales . RESULTS Mean baseline scores on the SF-36 scales were substantially below age-specific national norms . Problematic floor and /or ceiling effects were found for the bodily pain , social function , role -- physical , and role -- emotional scales , consistent with age-specific national norms . Internal consistency was unacceptable for the general health perceptions scale , adequate for the social function scale , and good for all the other SF-36 scales . Improvements greater than one st and ard error of measurement were found for between one fifth and one third of the patients , and declines greater than one st and ard error of measurement were found for between one fifth and one third of the patients . Selected baseline characteristics generally were unrelated to either improvements or declines on the SF-36 scales . CONCLUSIONS The SF-36 scales appear to be sufficiently sensitive for measuring changes in health outcomes during a 1-year period in older patients with debilitating disease . Little of the measured change , however , was predictable Study Design . Cohort study . Objectives . To estimate the Minimal Clinical ly Important Change ( MCIC ) of the pain intensity numerical rating scale ( PI-NRS ) , the Quebec Back Pain Disability Scale ( QBPDS ) , and the Euroqol ( EQ ) in patients with low back pain . Summary of Background Data . MCIC can provide valuable information for research ers , healthcare providers , and policymakers . Methods . Data from a r and omized controlled trial with 442 patients with low back pain were used . The MCIC was estimated over a 12-week period , and three different methods were used : 1 ) mean change scores , 2 ) minimal detectable change , and 3 ) optimal cutoff point in receiver operant curves . The global perceived effect scale ( GPE ) was used as an external criterion . The effect of initial scores on the MCIC was also assessed . Results . The  MCIC of the PI-NRS ranged from 3.5 to 4.7 points in (sub)acute patients and 2.5 to 4.5 points in chronic patients with low back pain . The  MCIC of the QBPDS was estimated between 17.5 to 32.9 points and 8.5 to 24.6 points for (sub)acute and chronic patients with low back pain . The  MCIC for the EQ ranged from 0.07 to 0.58 in (sub)acute patients and 0.09 to 0.28 in patients with chronic low back pain . Conclusion . Reporting the percentage of patients who have made a MCIC adds to the interpretability of study results . We present a range of MCIC values and advocate the choice of a single MCIC value according to the specific context Meta-analyses indicate that antidepressants are superior to placebos in statistical terms , but the clinical relevance of the differences has not been established . Previous suggestions of clinical ly relevant effect sizes have not been supported by empirical evidence . In the current paper we apply an empirical method that consists of comparing scores obtained on the Hamilton rating scale for depression ( HAM-D ) and scores from the Clinical Global Impressions-Improvement ( CGI-I ) scale . This method reveals that a HAM-D difference of 3 points is undetectable by clinicians using the CGI-I scale . A difference of 7 points on the HAM-D , or an effect size of 0.875 , is required to correspond to a rating of ' minimal improvement ' on the CGI-I. By these criteria differences between antidepressants and placebo in r and omised controlled trials , including trials conducted with people diagnosed with very severe depression , are not detectable by clinicians and fall far short of levels consistent with clinical ly observable minimal levels of improvement . Clinical significance should be considered alongside statistical significance when making decisions about the approval and use of medications like antidepressants
target: DISCUSSION Although cannabinoids are now being used to manage different pain conditions , the evidence for the clinical effects are unclear .
background: INTRODUCTION Pain is a frequent clinical symptom with significant impact on the patient 's well-being .
  Therefore , adequate pain management is of utmost importance .
  While cannabinoids have become a more popular alternative to traditional types of pain medication among patients , the quality of evidence supporting the use of cannabinoids has been question ed .
  The beneficial and harmful effects of cannabinoids in patients with pain is unknown .
  Accordingly , we aim to assess the efﬁcacy , tolerability and safety of cannabinoids ( herbal , plant-derived extracts and synthetic ) compared with placebo or no intervention for any type of pain .