Minimal Clinically Important Change Research Articles

Role of psychological distress screening in predicting the outcomes of epidural steroid injection in chronic low back pain

BackgroundThere is a paucity of studies investigating relationship between psychological distress and effectiveness of epidural steroid injection in patients with chronic lower back pain (CLBP). AimsThis prospective cohort study assessed whether the outcome can be predicted in CLBP patients undergoing epidural injection by pre-treatment psychological stress stratification using objective screening methods. Methods96 patients with CLBP were recruited to this prospective cohort study. Preoperative level of psychological distress was measured using Modified Zung Index (MZI) and Modified Somatic Perception Questionnaire (MSPQ); pain with Visual Analogue Score (VAS) and McGill Pain Questionnaire (MPQ) and back pain related disability with Oswestry Disability Index (ODI). Fluoroscopic caudal epidural steroid injection comprising 80 mg methylprednisolone and 8 mg of lignocaine was performed. Scores were repeated at 6, 12, and 26 weeks. Successful outcome was Minimal Clinically Important Change (MCIC) in any given measure. ResultsThere were 60 (62.5%) not-distressed patients, 3(3.1%) purely somatising, 15(15.6%) depressed and 18(18.8%) with mixed distress. Preoperative VAS was 82.4, MPQ 18.2 and ODI 51.6. Average VAS and MPQ improved significantly at 6 and 26 weeks. Average magnitude of change of VAS and ODI did not differ between distressed and not-distressed. MPQ improved significantly more in the distressed. MZI was negatively associated with VAS MCIC at 6 weeks and 6 months but it failed to predict the outcome independently. MSPQ was the only individual predictor of MPQ-MCIC at any time; MSPQ≥8 could predict MPQ-MCIC at 6 months with 53%-sensitivity and 78%-specificity. None of psychological measures used showed a significant predictive value of ODI at any follow-up point ConclusionsPsychological distress may predict response only in certain outcome measures in patients suffering from nonspecific CLBP. If the interest lied primarily in pain and functional improvement, the psychological distress failed to discriminate the results at 6 months.

The stereotactic prostate radiotherapy (SPORT) trial: A randomized feasibility study comparing prostate SABR to prostate and pelvic nodal SABR.

248 Background: Stereotactic Ablative Radiotherapy (SABR) is increasingly used to treat low/intermediate risk localised prostate cancer (PCa). However, data on SABR +/- pelvic nodal irradiation (PNI) in high-risk disease is limited to single institution, single-arm studies. The Stereotactic Prostate Radiotherapy (SPORT) trial examined the feasibility of delivering a randomised trial of SABR ± PNI. The composite primary endpoint to determine feasibility comprised: recruitment rate, technical feasibility, acute toxicity (CTCAE v4.0) and quality of life (QoL)(EPIC). Secondary and exploratory endpoints including late toxicity (RTOG) and QoL and potential biomarkers of toxicity (plasma citrulline and DNA damage in circulating lymphocytes) are also presented. Methods: Men with localised PCa demonstrating one of T3a, Gleason score ≥4+3 or PSA>20 were eligible. T3b and T4 disease were excluded. 30 participants were randomised 1:1 to prostate SABR (P-SABR) or prostate and pelvis SABR (PPN-SABR). The prostate and proximal 1-2cm seminal vesicles received 36.25 Gy in 5 fractions over 29 days (prostate CTV 40Gy). The PPN-SABR arm also received 25 Gy in 5 fractions to the pelvic nodes. All patients had fiducial markers and a rectal spacer gel in-situ. As initial toxicity rates were low, the final 10 men received an additional integrated boost to the dominant intraprostatic lesion of up to 50 Gy, irrespective of randomisation. Results: Feasibility was demonstrated. The target recruitment of 30 men was met (83% high risk). Treatment, including an integrated boost plus PNI, was achievable using strict normal tissue constraints. Acute toxicity and QoL were acceptable (Table: Grade≥2 GU 7%, 27% and GI 0%, 7%; minimal clinically important change (MCIC) in EPIC urinary 40%, 60% and bowel score 33%, 47% in P and PPN arms respectively). At median follow up of 30 months (range 18-42 months), late toxicity and QoL were acceptable (Grade≥2 GU 7%, 20% and GI 0%, 13%; MCIC in EPIC urinary 33%, 67% and bowel score 33%, 67% in P and PPN arms respectively). All toxicity was ≤ grade 2 with the exception of one late grade 3 GU toxicity occurring in the PPN arm. Serum citrulline, a marker of small bowel function, trended towards lower levels in the PPN arm, in keeping with a significantly higher dose delivered to the small bowel in this arm. DNA damage foci in circulating lymphocytes increased at 1 hour after radiation. Foci count and repair correlated to toxicity measures will be presented. Conclusions: A randomised clinical trial comparing P-SABR to PPN-SABR is feasible. There was a suggestion of increased toxicity with PPN-SABR, but this remained acceptable. This data will inform a UK multi-centre phase 2 study. Clinical trial information: NCT03253978 . [Table: see text]

Association between the appropriateness of surgery, according to appropriate use criteria, and patient-rated outcomes after surgery for lumbar degenerative spondylolisthesis.

Treatment failures in spine surgery are often attributable to poor patient selection and the application of inappropriate treatment. We used published appropriate use criteria (AUC) to evaluate the appropriateness of surgery in a large group of patients operated for lumbar degenerative spondylolisthesis (LDS) and to evaluate its association with outcome. This was a retrospective analysis of prospectively collected outcome data from patients operated in our Spine Centre, 2005-2012. Appropriateness of surgery was judged based on the AUC. Patients had completed the multidimensional Core Outcome Measures Index (COMI) before surgery and at 3 months' and 1, 2 and 5years' follow-up (FU). In total, 448 patients (69.8 ± 9.6years; 323 (72%) women) were eligible for inclusion and the AUC could be applied in 393 (88%) of these. Surgery was considered appropriate (A) in 234 (59%) of the patients, uncertain/equivocal (U) in 90 (23%) and inappropriate (I) in 69 (18%). A/U patients had significantly (p < 0.05) greater improvements in COMI than I patients at each FU time point. The minimal clinically important change (MCIC) score for COMI was reached by 82% A, 76% U and 54% I patients at 1-year FU (p < 0.001, I vs A and U); the odds of achieving MCIC were 3-4 times greater in A/U patients than in I patients. The results suggest a relationship between appropriateness of surgery for LDS and the improvements in COMI score after surgery. The findings require confirmation in prospective studies that also include a control group of non-operated patients.

Effectiveness of dry needling in the treatment of neck pain and disability associated with myofascial trigger points

Objective: The aim of this study is to evaluate the effectiveness of dry needling (DN) with fast-in and fast-out technique for myofascial trigger points (MTrPs) in the upper trapezius muscle associated with neck pain. Patients and Methods: Patients aged 18-70 years, who have had neck pain at least one active MTrP in the upper trapezius muscle treated with DN, were included in the study. Pain and disability were assessed with Numeric Rating Scale (NRS) and Neck Disability Index (NDI) before treatment (T0), after first session (T1) and after last session (T2). Number of MTrPs where DN was performed and the number of DN sessions were recorded. Patients were evaluated based on the minimal clinically important change (MCIC) scores for NRS and NDI. Results: A total of 76 patients (Female: 67, Male: 9) were included in the study. Median number of DN sessions was 3 and median of MTrPs that DN performed was 4. Both NRS and NDI showed significant improvement at T1 and T2. More than 90% of patients had MCIC at T1 and T2. Conclusion: Dry needling with fast-in and fast-out technique is effective for pain and disability management in patients with neck pain due to MTrPs.

Measurement properties of the musculoskeletal health questionnaire (MSK-HQ): a between country comparison

BackgroundThe Musculoskeletal Health Questionnaire (MSK-HQ) has been developed to measure musculoskeletal health status across musculoskeletal conditions and settings. However, the MSK-HQ needs to be further evaluated across settings and different languages.ObjectiveThe objective of the study was to evaluate and compare measurement properties of the MSK-HQ across Danish (DK) and English (UK) cohorts of patients from primary care physiotherapy services with musculoskeletal pain.MethodsMSK-HQ was translated into Danish according to international guidelines. Measurement invariance was assessed by differential item functioning (DIF) analyses. Test-retest reliability, measurement error, responsiveness and minimal clinically important change (MCIC) were evaluated and compared between DK (n = 153) and UK (n = 166) cohorts.ResultsThe Danish version demonstrated acceptable face and construct validity. Out of the 14 MSK-HQ items, three items showed DIF for language (pain/stiffness at night, understanding condition and confidence in managing symptoms) and three items showed DIF for pain location (walking, washing/dressing and physical activity levels). Intraclass Correlation Coefficients for test-retest were 0.86 (95% CI 0.81 to 0.91) for DK cohort and 0.77 (95% CI 0.49 to 0.90) for the UK cohort. The systematic measurement error was 1.6 and 3.9 points for the DK and UK cohorts respectively, with random measurement error being 8.6 and 9.9 points. Receiver operating characteristic (ROC) curves of the change scores against patients’ own judgment at 12 weeks exceeded 0.70 in both cohorts. Absolute and relative MCIC estimates were 8–10 points and 26% for the DK cohort and 6–8 points and 29% for the UK cohort.ConclusionsThe measurement properties of MSK-HQ were acceptable across countries, but seem more suited for group than individual level evaluation. Researchers and clinicians should be aware that some discrepancy exits and should take the observed measurement error into account when evaluating change in scores over time.

The responsiveness and interpretability of psychosocial patient-reported outcome measures in chronic musculoskeletal pain rehabilitation.

For several widely used patient-reported outcome measures (PROMs) in chronic musculoskeletal pain (CMSP) rehabilitation, it is still not known whether they are responsive to change, and what the smallest detectable change (SDC) and minimal clinically important change (MCIC) are. Knowledge of these values can be used to accurately interpret change scores in research and clinical practice. In this retrospective cohort study, the responsiveness, the SDC and the MCIC of the mental components of the Research and Development 36-Item Health Survey (RAND-36), the Pain Catastrophizing Scale (PCS) and the Tampa Scale of Kinesiophobia (TSK) were investigated in CMSP patients. Responsiveness, the SDC and MCIC were determined by using both anchor and distribution-based methods. For all outcome measures, there was a progression from smallest to largest mean change scores between participants who did not perceive change and those who reported change after treatment. However, correlations of the Global Perceived Effect (GPE) with the change scores on the outcome measures were low. For all outcome measures, the SDC was larger than the MCIC. For this population, the questionnaires were shown not to be responsive. Furthermore, the questionnaires appeared not to be able to distinguish clinically important change from measurement error in individual patients. The finding of large measurement errors of PROMs is in line with previous research in pain rehabilitation. Using generic PROMs only, to examine changes in psychosocial status due to a pain rehabilitation programme, is therefore questionable. This study shows that widely used generic psychosocial PROMs might not be responsive and not able to distinguish clinically important change from measurement error in individual chronic musculoskeletal pain patients. It therefore seems reasonable to reconsider the (compulsory) use of these PROMs for assessing the quality of pain rehabilitation programmes, and necessary to consider other, more objective, outcome measures for this purpose in this population.

Interpreting Outcomes 3-Clinical Meaningfulness: Linking Evidence to Practice.

To judge whether one treatment is more effective than another, we need to know how big the difference is. One way of judging the size of the difference reported in a trial is to ask whether it is "clinically meaningful" (or clinically worthwhile): "The smallest change that is important to patients." A treatment is often said to be "effective" and recommended for practice when the between-group difference in a study is larger than the clinically meaningful effect. But this simple idea hides some complexity. This Evidence in Practice article aims to explain the definitions, interpretations, and implications of minimally important change (MIC), minimal clinically important change (MCIC), and minimal clinically important difference (MCID). J Orthop Sports Phys Ther 2019;49(9):677-678. doi:10.2519/jospt.2019.0705.

Minimal clinically important change in patients with cervical dystonia: Results from the CD PROBE study

ObjectiveTo determine the minimal clinically important change (MCIC) on Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scores using data from Cervical Dystonia Patient Registry for Observation of OnabotulinumtoxinA Efficacy (CD PROBE), which captured real-world practices and outcomes. MethodsChanges in the baseline TWSTRS scores (point and percentage changes) were compared to changes in the Patient and Clinician Global Impression of Change (PGIC and CGIC) ratings. Using logistic regression, the discrimination of the model was determined. ResultsAmong the 479 patients who completed all TWSTRS assessments, the mean TWSTRS Total score significantly decreased from baseline (39.2) to the final visit (27.1) (P < .0001). TWSTRS Total score point changes that compared with PGIC assessments “very much improved,” “much improved” or better, and “minimally improved” or better were −11, −9, and −8, respectively, and were similar to previously published changes (ie, a decrease of ≥10 points). TWSTRS Total score data met indicators of good cutoffs for discrimination of the model including ≥70% percentage of outcomes correctly classified when compared with PGIC ratings. The TWSTRS Total score mapped to PGIC and CGIC ratings better than any TWSTRS subscale score. ConclusionsThe MCIC for improvement was ≥8 points based on mean TWSTRS Total scores in patients with cervical dystonia when compared against the patient-based evaluation of benefit (PGIC).

Modern trunnion designs do not affect clinically significant patient-reported outcomes.

Trunnion geometry is known to vary between hip systems. Trunnionosis and the impact of trunnion design on total hip arthroplasty (THA) survival, has gained attention as a failure mechanism. We sought to report the differences in patient-reported outcome measures (PROMs) between the most commonly utilised modern THA trunnions. We reviewed primary unilateral THA patients from May 2007 to October 2011. The most frequently used stems were included. LEAS, HOOS subdomains, and SF-12 were obtained pre and post operatively while satisfaction was measured at 2 years after THA. Trunnions were grouped by taper geometry and manufacturer. The 2-year change in PROMs for each trunnion was compared to the pooled 2-year change in HOOS for all other trunnions. 3950 THA patients were studied. 6 trunnion designs were evaluated from 5 manufacturers. The range in differences between the 2-year change in individual PROMs were as follows: HOOS pain (0.6-2.4), HOOS symptoms (0-3.8), HOOS ADL (0.4-4), and HOOS QOL (0.5-3.6). None of the differences in the 2-year change in PROMs reached a minimal clinically important change (MCIC), which we previously determined to be a minimum of 9 points for all HOOS domains. All of the trunnions designs utilised in our study cohort demonstrated excellent clinical results. Small differences were well below the known MCIC; and were not clinically relevant. The findings of this study should prompt further investigations into the long-term impact of trunnion design on clinical patient-reported outcomes.

Two versus five stereotactic ablative radiotherapy treatments for localized prostate cancer: A quality of life analysis of two prospective clinical trials

PurposeStereotactic ablative radiotherapy (SABR) is appealing for prostate cancer (PCa) due to low α/β, and increasing the dose per fraction could improve the therapeutic index and lead to a better quality of life (QOL). Here we report the outcomes of a QOL comparison between two phase II clinical trials: two vs. five fraction prostate SABR. MethodsPatients had low or intermediate risk PCa. The doses prescribed were 26 Gy/2 and 40 Gy/5. Expanded prostate cancer index composite was collected. Urinary, bowel and sexual domains were analyzed. Minimal clinically important change (MCIC) was defined as >0.5 standard deviation. Results30 and 152 patients were treated with 2-fraction and 5-fraction SABR. Median follow-up was 55 and 62 months. Five-year biochemical failure rate was 3.3% and 4.6%. The 2-fraction cohort had a significantly better mean QOL over time in the bowel domain (p = 0.0004), without a significant difference in the urinary or sexual domains. The 2-fraction cohort had a significantly lower rate of bowel MCIC (17.8% vs 42.3%, p = 0.01), but there was no difference in urinary (24.1% vs 35.7%) or sexual (15.3% vs 29.2%) MCIC. For MCIC x2 (moderate QOL change), the 2-fraction trial had significantly lower MCIC rates in both the bowel (7.1% vs 24%, p = 0.04) and sexual (0 vs 17.6%, p = 0.01) domains. Conclusions2-Fraction SABR is feasible to deliver and well tolerated, with significant signals of improved bowel and sexual QOL. A randomized trial of two vs. five fractions for prostate SABR is needed to confirm the promising findings of this study.

Responsiveness of the Victorian Institute for Sport Assessment for Gluteal Tendinopathy (VISA-G), modified Harris hip and Oxford hip scores in patients undergoing hip abductor tendon repair

BackgroundA lack of consensus exists on which patient-reported outcome measures (PROMs) best evaluate change following hip abductor tendon (HAT) repair. ObjectivesTo compare the responsiveness of the Victorian Institute for Sport Assessment for Gluteal Tendinopathy (VISA-G), Oxford Hip (OHS) and modified Harris Hip (mHHS) scores in patients undergoing HAT repair. Study designProspective case series. Methods56 patients underwent HAT repair and were evaluated pre-surgery and 3, 6 and 12 months post-operatively using the VISA-G, OHS, mHHS and a Global Rating of Change (GRC) scale. Internal and external responsiveness, the minimal clinically important change (MIC) and the presence of ceiling effects were evaluated. The extent to which VISA-G change was associated with mHHS and OHS change was investigated, as was the extent to which PROM changes were discriminatory for GRC improvement. ResultsAll PROMs demonstrated large standardized effect sizes (>1), with the VISA-G demonstrating responsiveness similar to the mHHS and OHS. At 12 months, the GRC correlated similarly with VISA-G (0.42, 95% CI: 0.17–0.61), mHHS (0.44, 95% CI: 0.17–0.61) and OHS (0.53, 95% CI: 0.31–0.70) changes. Using a GRC anchor of ≥4, an MIC of 29/100, 29/91 (32/100) and 16/48 (33/100) was observed for the VISA-G, mHHS and OHS, respectively. At 12 months ceiling effects existed for the mHHS (18/56, 32.1%) and OHS (13/56, 23.2%), but not VISA-G (1/56, 1.8%). ConclusionThe VISA-G demonstrated acceptable responsiveness and was more resistant to ceiling effects, though demonstrated similar change scores and correlations with perceived improvement to the mHHS and OHS. Clinical trial registrationThis research trial is registered in the Australian New Zealand Clinical Trials Registry (ACTRN12616001655437).

The NIH Minimal Dataset for Chronic Low Back Pain: Responsiveness and Minimal Clinically Important Change.

Prospective cohort study. To analyze responsiveness and minimal clinically important change (MCIC) of the US National Institutes of Health (NIH) minimal dataset for chronic low back pain (CLBP). The NIH minimal dataset is a 40-item questionnaire developed to increase use of standardized definitions and measures for CLBP. Longitudinal validity of the total minimal dataset and the subscale Impact Stratification are unknown. Total outcome scores on the NIH minimal dataset, Dutch Language Version, were calculated ranging from 0 to 100 points with higher scores representing worse functioning. Responsiveness and MCIC were determined with an anchor-based method, calculating the area under the receiver operating characteristics (ROC) curve (AUC) and by determining the optimal cut-off point. Smallest detectable change (SDC) was calculated as a parameter of measurement error. In total 223 patients with CLBP were included. Mean total score on the NIH minimal dataset was 44 ± 14 points at baseline. The total outcome score was responsive to change with an AUC of 0.84. MCIC was 14 points with a sensitivity of 72% and specificity 82%, and SDC was 23 points. Mean total score on Impact Stratification (scale 8-50) was 34.4 ± 7.4 points at baseline, with an AUC of 0.91, an MCIC of 7.5 with a sensitivity 96% of and specificity of 78%, and an SDC of 14 points. The longitudinal validity of the NIH minimal dataset is adequate. An improvement of 14 points in total outcome score and 7.5 points in Impact Stratification can be interpreted as clinically important in individual patients. However, MCIC depends on baseline values and the method that is chosen to determine the optimal cut-off point. Furthermore, measurement error is larger than the MCIC. This means that individual change scores should be interpreted with caution. 2.

Platelet-rich plasma (PRP) treatment of noninsertional Achilles tendinopathy in a two case series: no significant difference in effect between leukocyte-rich and leukocyte-poor PRP.

BackgroundThere is a theoretical basis for the treatment of chronic tendinopathies by platelet-rich plasma (PRP), and it can, therefore, be considered a possible treatment of chronic Achilles tendinopathies (CATs), even though the clinical evidence for the use is not clear and, in addition, there is a lack of treatment algorithms and it is unclear which type of PRP is most effective. The objective of this study was through the comparison of two case series to assess: 1) the effect of PRP on CAT and 2) if there is any difference in effect between leukocyte-rich PRP (LR-PRP) and leukocyte-poor PRP (LP-PRP) in the treatment of CAT.Patients and methodsTwo separate series of achilles tenodinopathies treated with either LR-PRP or LP-PRP were evaluated with a natural experiment/quasi-experimental study design, with a short-term (2 months) and long-term (8–42 months) follow-up to assess the effect and stability of the treatment. In total, 84 patients with failed basic treatment for CAT for at least 6 months were treated with either Biomet’s GPS III recovery kit with LR-PRP (36 patients) or with Arthrex ACP LP-PRP (48 patients).ResultsThe overall probability of reaching a minimal clinically important change (MCIC) of at least 30% reduction in visual analog scale (VAS) was in activity (63%) and during rest (81%), and for Victorian Institute of Sport Assessment Scale (VISA-A), it was 61%. There was no statistical difference in change of VISA-A score or VAS between the patients treated with LP-PRP and LR-PRP.ConclusionPRP seems to be a possible treatment when all other treatment regimens have failed, with a reasonably high probability of reaching MCIC. The choice of either LR-PRP or LP-PRP seems to be up to personal preference as there were no significant differences between patients treated with LR-PRP and LP-PRP.

Two StereoTactic ablative radiotherapy treatments for localized prostate cancer (2STAR): Results from a prospective clinical trial

PurposeUltrahypofractionation is appealing for prostate cancer (PCa) due to low α/β, and increasing the dose per fraction could improve the therapeutic index. Here we report the outcomes of a phase II prostate SABR trial using two fractions. MethodsPatients had low or intermediate risk prostate cancer. Three gold fiducials were implanted for image guidance. The clinical target volume (CTV) included the prostate only, and the planning target volume (PTV) was a 3 mm expansion enabled through the use of a rectal immobilization device. The dose prescribed was 26 Gy in 2 weekly fractions (EQD2 110 Gy1.4). The primary endpoint was quality of life using EPIC, and minimal clinically important change (MCIC) was defined as an EPIC QOL decrease >0.5 SD. Results30 patients were accrued with a median follow-up of 49.3 months. 10% had low-risk, 33% had favourable intermediate-risk and 57% had unfavourable intermediate-risk PCa. Five patients received a short course of ADT. Median nPSA was 0.2 ng/ml. One patient had BF and is being observed. 56.6% of patients had a 4yPSARR. Six (20.7%) patients had a MCIC in the urinary domain, 6 (21.4%) had a MCIC in the bowel domain, and 3 (20%) had a MCIC in the sexual domain. ConclusionsTwo-fraction SABR in prostate cancer is safe and feasible, with a minimal change in QOL and a low rate of late grade 3–4 toxicity. The PSA kinetics and biochemical control rates are encouraging given that the majority had unfavourable intermediate-risk disease, although longer follow-up is required.

Responsiveness of Minimal Clinically Important Change for the Persian Functional Rating Index in Patients with Chronic Low Back Pain.

Study DesignA prospective, within-group cohort study of 46 patients with chronic low-back pain (CLBP).PurposeTo assess the responsiveness of the Persian Functional Rating Index (PFRI) and to determine the minimal clinically important change (MCIC) of the PFRI in a cohort of patients with CLBP.Overview of LiteratureThe FRI is an instrument for assessing pain and disability in patients with low-back pain. No study so far has examined the responsiveness of the PFRI.MethodsForty-six patients with CLBP with a mean age of 50.33±14.28 completed the PFRI, the Persian Roland–Morris Disability Questionnaire (PRMDQ), and a Visual Analog Scale (VAS) before and after 10 physiotherapy sessions. A Global Rating of Change Scale (GRCS) was completed after treatment.ResultsThe changes in PFRI scores were statistically significant using the paired t-test (p<0.001). The PFRI revealed high effect sizes (range, 0.93–1.82). The PFRI showed significant correlations with the VAS (0.86), the PRMDQ (0.66), and the GRCS (0.45). The area under the receiver operator characteristic curve for the PFRI was good (0.76; 95% confidence interval, 0.56–0.95). The MCIC for PFRI was 10.63 points.ConclusionsThe results supported the responsiveness of the PFRI in patients with CLBP and showed the amount of change in PFRI scores perceived as worthwhile by the patients.

The Responsiveness of Oxford Knee Score in Iranian Patients with Knee Osteoarthritis Following Physiotherapy Intervention

Introduction : The main purpose of physiotherapy in patients with knee osteoarthritis includes reducing pain, improving individual functional abilities, and increasing quality of life. Thus, the therapists need a tool to measure the outcome of these changes after intervention. In order to utilize these tools, they should have acceptable validity, reliability, and responsiveness. The Oxford Knee Score (OKS) is one of the most common tools used for assessment of the patients with knee osteoarthritis. However, to our knowledge, there has been no study on its responsiveness in this group of the patients. Therefore, the purpose of this study was to investigate the responsiveness of this outcome measure, and to measure minimal clinically important change in the patients with knee osteoarthritis following physiotherapy. Materials and Methods : 146 Iranian men and women with knee osteoarthritis referred to physiotherapist were entered the study via a nonrandomized convenience sampling method. The Oxford Knee Score was completed in the first session, and again after four weeks of physiotherapy. In the last session, the patients filled a 7-item retrograde Likert questionnaire, too Results : The area under the curve (AUC) of 0.78, and δ correlation coefficient of 0.59 indicated high responsiveness of Oxford Knee Score. The sensitivity and specificity of scale was 0.50 and 0.91, respectively. The minimal clinically important change (MCIC) of this tool was 6.5. Conclusion : Our findings provide evidence for selection of appropriate outcome measure for assessment of changes in these patients. The minimal clinically important change of this tool was determined which provide practical information for clinicians to make decision on clinical significance of changes in patients status.

Three-year safety, efficacy and persistence data following the daily use of mirabegron for overactive bladder in the clinical setting: A Japanese post-marketing surveillance study.

ObjectiveThe aim of this study was to report the final 3‐year results from a surveillance study evaluating the safety, efficacy, and persistence of mirabegron for treating overactive bladder (OAB) symptoms.MethodsPatients who had started mirabegron for the treatment of urinary urgency, daytime frequency, and urgency urinary incontinence symptoms associated with OAB were followed for 3 years. Adverse drug reactions (ADRs), residual urine volume measurements, OAB symptoms, Overactive Bladder Symptom Scores (OABSS), and treatment discontinuations were evaluated prospectively. Persistence was estimated using the Kaplan–Meier method.ResultsOf the 1138 patients included in the study (mean ±SD age: 71.9 ± 11.0 years; 574 [50.4%] women), 97 (8.52%) experienced 109 ADRs, with the incidence of ADRs decreasing over time (<1 year: 1.34%–2.37%; ≥1–<2 years: 0.45%–1.60%; ≥2–<3 years: 0.29%–1.10%; 3‐monthly interval data). No significant increases in residual urine volume were observed. The investigators considered mirabegron to be an effective treatment for 842 of 1082 (77.8%) patients. Significant decreases in OABSS were reported throughout (P < 0.001), and 321 (65.1%) patients achieved a minimal clinically important change (MCIC) in OABSS. Most patients who achieved an MCIC within ≤1 year continued to maintain an MCIC throughout the study. Treatment persistence rates after 1, 2, and 3 years of mirabegron treatment were 65.8%, 52.9%, and 46.7%, respectively.ConclusionOver 3 years, mirabegron was well tolerated and no cumulative events or delayed ADRs were observed. Mirabegron was an effective treatment with early improvements in OABSS being maintained throughout the treatment period. High persistence was observed after the use of mirabegron.

Minimal clinically important change in the Toronto Western Spasmodic Torticollis Rating Scale

ObjectivesTo characterize the minimal clinically important change (MCIC) after treatment in cervical dystonia patients using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS). MethodsChanges in the TWSTRS from an observational study of abobotulinumtoxinA in the routine management of cervical dystonia (NCT01314365) were analyzed using the Patient Global Impression of Change (PGIC) as anchor. ResultsFor the overall population (N = 304, baseline TWSTRS-Total score 43.4 ± 19.4), the MCIC for the TWSTRS Total score was −11.9 (95%CI: −13.9, −10.0; p < 0.0001). However, thresholds ranged from −3.2 to −18.0 dependent on baseline severity. TWSTRS-Total scores improved linearly by 3 points for every one-point PGIC increase. There was similar linearity between the graded PGIC categories and TWSTRS subscale scores (severity, disability, and pain). ConclusionsA 3-point change is the minimal clinically important change after treatment using TWSTRS as endpoint with higher cutoffs for greater baseline disease severity. For an average trial population (TWSTRS-total: 40–45), a 12-point decrease is clinically meaningful.

Patient-reported outcome of surgical treatment for lumbar spinal epidural lipomatosis

Background ContextSpinal epidural lipomatosis (SEL) is a rare condition characterized by an excessive accumulation of fat tissue in the spinal canal that can have a compressive effect, leading to clinical symptoms. This condition has a distinct pathology from spinal stenosis associated with degeneration of the intervertebral discs, ligaments, and facet joints. Several different conservative and surgical treatment strategies have been proposed for SEL, but its treatment remains controversial. There is a lack of evidence documenting the success of surgical decompression in SEL, and no previous studies have reported the postoperative outcome from the patient's perspective. PurposeThe aim of the present study was to evaluate patient-rated outcome after surgical decompression in SEL. Study DesignA retrospective analysis of prospectively collected data was carried out. Patient SampleA total of 22 patients (19 males; age: 68.2±9.9 years) who had undergone spine surgery for SEL were identified from our local Spine Surgery Outcomes Database, which includes a total of 10,028 spine surgeries recorded between 2005 and 2012. Inclusion criteria were epidural lipomatosis confirmed by preoperative magnetic resonance imaging (MRI) scans and subsequent decompression surgery without spinal fusion. Outcome MeasuresThe Core Outcome Measures Index (COMI) was used to assess patient-rated outcome. The COMI includes the domains pain (separate 0–10 scales for back and leg pain), back-specific function, symptom-specific well-being, general quality of life (QOL), work disability, and social disability. MethodsThe questionnaires were completed preoperatively and at 3, 12, and 24 months postoperatively. Surgical data were retrieved from the patient charts and from our local Spine Surgery Outcomes Database, which we operate in connection with the International Spine Tango Registry. Differences between pre- and postoperative scores were analyzed using paired t tests and repeated measures analysis of variance. ResultsAt 3-months follow-up, the COMI score and scores for leg pain and back pain had improved significantly compared with their preoperative values (p<.005). The mean decrease in COMI score after 3 months was 2.6±2.4 (range: −1.3 to 6.5) points: from 7.5±1.7 (range: 3.5–10) to 4.9±2.5 (range: 0.5–9.6). A total of 11 patients (50%) had an improvement of the COMI of more than the minimal clinically important change (MCIC) score of 2.2 points. The mean decrease in leg pain after 3 months was 2.4±3.5 (−5 to 10) points. Overall, 17 patients (77.3%) reported a reduced leg pain, 12 (54.6%) of whom by at least the MCIC score of 2 points. The significant reductions from baseline in COMI and leg and back pain scores were retained up to 2 years postoperatively (p<.02).The general QOL item of the COMI improved significantly after surgery (p<.0001). Over 80% of the cohort rated their preoperative QOL as bad (n=13) or very bad (n=5), whereas 3 months after surgery, only 7 patients rated their QOL as bad, and one as very bad (36%). ConclusionsThe present study is the first to demonstrate that surgical decompression is associated with a statistically significant improvement in patient-rated outcome scores in patients with symptomatic SEL, with a clinically relevant change occurring in approximately half of them. Surgical decompression hence represents a reasonable treatment option for SEL, although the reason behind the less good response in some patients needs further investigation.

Estimation of minimal clinically important change of the Japanese version of EQ-5D in patients with chronic noncancer pain: a retrospective research using real-world data.

BackgroundQuality of life (QoL) is routinely assessed and evaluated in medical research. However, in Japan, there is a lack of solid cutoff criteria for evaluating QoL improvement in chronic noncancer pain management. The present study was conducted to identify the minimal clinically important change (MCIC) of the Japanese version of EuroQol-5D 3L(EQ-5D) utility score and numeric rating scale (NRS) with an emphasis on chronic noncancer pain.MethodsThe data source for this post hoc research was the post-marketing surveillance (PMS) data for a tramadol/acetaminophen combination tablet, which was previously conducted in real-world settings. The parameters extracted from the PMS data were sociodemographic characteristics, NRS, EQ-5D, and dichotomous physician’s global impression of treatment effectiveness (PGI). The optimal cutoff points of MCIC for EQ-5D utility and NRS scores were evaluated using receiver operating characteristics (ROC) analysis. An anchor-based approach using PGI was applied.ResultsData of 710 patients with chronic noncancer pain were extracted from the PMS database. The NRS score decreased by 2.7 (standard deviation, 2.3) points, whereas the EQ-5D score increased by 0.16 (0.20) points at 4 weeks from baseline. The changes from baseline in NRS and EQ-5D were significantly correlated (r = 0.53, p < 0.001). The estimated optimal cutoff points of MCIC for EQ-5D and NRS were 0.10 and −2.0 points, respectively. The area under the curve of ROC was > 0.80 in both analyses.ConclusionThese results demonstrated novel cutoff criteria for the Japanese version of EQ-5D, focusing on patients with chronic noncancer pain. The obtained criteria were fairly consistent and can be confidently utilized as an evaluation tool in medical research on chronic noncancer pain in Japan, with additional functionality and usability for QoL assessment in pain management practice.Trial registrationThe data source of this post hoc research was a PMS study with the identifier number UMIN000015901 at umin.ac.jp, UMIN clinical trial registry (UMIN-CTR).