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The minimum clinically important difference (MCID) is used to interpret the relevance of treatment effects, e.g., when developing clinical guidelines, evaluating trial results or planning sample sizes. There is currently no agreement on an appropriate MCID in chronic pain and little is known about which contextual factors cause variation. This is a systematic review. We searched PubMed, EMBASE, and Cochrane Library. Eligible studies determined MCID for chronic pain based on a one-dimensional pain scale, a patient-reported transition scale of perceived improvement, and either a mean change analysis (mean difference in pain among minimally improved patients) or a threshold analysis (pain reduction associated with best sensitivity and specificity for identifying minimally improved patients). Main results were descriptively summarized due to considerable heterogeneity, which were quantified using meta-analyses and explored using subgroup analyses and metaregression. We included 66 studies (31.254 patients). Median absolute MCID was 23 mm on a 0–100 mm scale (interquartile range [IQR] 12–39) and median relative MCID was 34% (IQR 22–45) among studies using the mean change approach. In both cases, heterogeneity was very high: absolute MCID I2 = 99% and relative MCID I2 = 96%. High variation was also seen among studies using the threshold approach: median absolute MCID was 20 mm (IQR 15–30) and relative MCID was 32% (IQR 15–41). Absolute MCID was strongly associated with baseline pain, explaining approximately two-thirds of the variation, and to a lesser degree with the operational definition of minimum pain relief and clinical condition. A total of 15 clinical and methodological factors were assessed as possible causes for variation in MCID. MCID for chronic pain relief vary considerably. Baseline pain is strongly associated with absolute, but not relative, measures. To a much lesser degree, MCID is also influenced by the operational definition of relevant pain relief and possibly by clinical condition. Explicit and conscientious reflections on the choice of an MCID are required when classifying effect sizes as clinically important or trivial.

Background Clinical interpretation of changes measured on a scale is dependent on knowing the minimum clinically important difference (MCID) for that scale: the threshold above which clinicians, patients, and researchers perceive an outcome difference. Until now, approaches to determining MCIDs were based upon individual studies or surveys of experts. However, the comparison of meta-analytic treatment effects to a MCID derived from a distribution of standard deviations (SDs) associated with all trial-specific outcomes in a meta-analysis could improve our clinical understanding of meta-analytic treatment effects. Methods We approximated MCIDs using a distribution-based approach that pooled SDs associated with baseline mean or mean change values for two scales (i.e. Mini-Mental State Exam [MMSE] and Alzheimer Disease Assessment Scale – Cognitive Subscale [ADAS-Cog]), as reported in parallel randomized trials (RCTs) that were included in a systematic review of cognitive enhancing medications for dementia (i.e. cholinesterase inhibitors and memantine). We excluded RCTs that did not report baseline or mean change SD values. We derived MCIDs at 0.4 and 0.5 SDs of the pooled SD and compared our derived MCIDs to previously published MCIDs for the MMSE and ADAS-Cog. Results We showed that MCIDs derived from a distribution-based approach approximated published MCIDs for the MMSE and ADAS-Cog. For the MMSE (51 RCTs, 12,449 patients), we derived a MCID of 1.6 at 0.4 SDs and 2 at 0.5 SDs using baseline SDs and we derived a MCID of 1.4 at 0.4 SDs and 1.8 at 0.5 SDs using mean change SDs. For the ADAS-Cog (37 RCTs, 10,006 patients), we derived a MCID of 4 at 0.4 SDs and 5 at 0.5 SDs using baseline SDs and we derived a MCID of 2.6 at 0.4 SDs and 3.2 at 0.5 SDs using mean change SDs. Conclusion A distribution-based approach using data included in a systematic review approximated known MCIDs. Our approach performed better when we derived MCIDs from baseline as opposed to mean change SDs. This approach could facilitate clinical interpretation of outcome measures reported in RCTs and systematic reviews of interventions. Future research should focus on the generalizability of this method to other clinical scenarios.

Background Appropriately defining and using the minimal important change (MIC) and the minimal clinically important difference (MCID) are crucial for determining whether the results are clinically significant. The aim of this study is to survey the status of randomized controlled trials (RCTs) for insomnia interventions to assess the inclusion and interpretation of MIC/MCID values. Methods We conducted a cross-sectional study to survey the status of RCTs for insomnia interventions to assess the inclusion and appropriate interpretation of MIC/MCID values. A literature search was conducted by searching the main sleep medicine journals indexed in PubMed, the Excerpta Medica Database (EMBASE), and the Cochrane Central Register of Controlled Trials (CENTRAL) to identify a broad range of search terms. We included RCTs with no restriction on the intervention. The included studies used the Insomnia Severity Index (ISI) or the Pittsburgh Sleep Quality Index (PSQI) questionnaire as the outcome measures. Results 81 eligible studies were identified, and more than one-third of the included studies used MIC/MCID ( n  = 31, 38.3%). Among them, 21 studies with ISI as the outcome used MIC defined as a relative decrease ranging from 3 to 8 points. The most frequently used MIC value was a 6-point decrease ( n  = 7), followed by 8-point ( n  = 6) and 7-point decrease ( n  = 4), a 4 to 5-points decrease ( n  = 3), and a 30% reduction from baseline; 6 studies used MCID values, ranging from 2.8 to 4 points. The most frequently used MCID value was a 4-point decrease in the ISI ( n  = 4). 4 studies with PSQI as the outcome used a 3-point change as the MIC ( n  = 2) and a 2.5 to 2.7-point difference as MCID ( n  = 2). 4 non-inferiority design studies considered interval estimation when drawing clinically significant conclusions in their MCID usage. Conclusions The lack of consistent MIC/MCID interpretation and usage in outcome measures for insomnia highlights the urgent need for further efforts to address this issue and improve reporting practices.

Background and purpose Spinal muscular atrophy (SMA) is a rare and progressive neuromuscular disorder with varying severity levels. The aim of the study was to calculate minimal clinically important difference (MCID), minimal detectable change (MDC), and values for the Hammersmith Functional Motor Scale Expanded (HFMSE) in an untreated international SMA cohort. Methods The study employed two distinct methods. MDC was calculated using distribution‐based approaches to consider standard error of measurement and effect size change in a population of 321 patients (176 SMA II and 145 SMA III), allowing for stratification based on age and function. MCID was assessed using anchor‐based methods (receiver operating characteristic [ROC] curve analysis and standard error) on 76 patients (52 SMA II and 24 SMA III) for whom the 12‐month HFMSE could be anchored to a caregiver‐reported clinical perception questionnaire. Results With both approaches, SMA type II and type III patients had different profiles. The MCID, using ROC analysis, identified optimal cutoff points of −2 for type II and −4 for type III patients, whereas using the standard error we found the optimal cutoff points to be 1.5 for improvement and −3.2 for deterioration. Furthermore, distribution‐based methods uncovered varying values across age and functional status subgroups within each SMA type. Conclusions These results emphasize that the interpretation of a single MCID or MDC value obtained in large cohorts with different functional status needs to be made with caution, especially when these may be used to assess possible responses to new therapies.

The application and interpretation of patient-reported outcome measures (PROM), following knee injuries, pathologies, and interventions, can be challenging. In recent years, the literature has been enriched with metrics to facilitate our understanding and interpretation of these outcome measures. Two commonly utilized tools include the minimal clinically important difference (MCID) and the patient acceptable symptoms state (PASS). These measures have demonstrated clinical value, however, they have often been under- or mis-reported. It is paramount to use them to understand the clinical significance of any statistically significant results. Still, it remains important to know their caveats and limitations. In this focused report on MCID and PASS, their definitions, methods of calculations, clinical relevance, interpretations, and limitations are reviewed and presented in a simple approach.

Background The impact of surgical interventions on lumbar disc herniation (LDH) is often assessed using objective functional impairment (OFI) tests like the five-repetition sit-to-stand (5R-STS) test. This study calculates the minimum clinically important difference (MCID) for 5R-STS improvement in patients with LDH one year after surgery. Methods Adult patients with LDH scheduled for surgery were prospectively recruited from a Dutch short-stay spinal clinic. The 5R-STS time, Oswestry Disability Index (ODI), Roland-Morris Disability Questionnaire (RMDQ), Numeric Rating Scale for back and leg pain, EQ-5D-3L health-related quality of life questionnaire and EQ5D-VAS were recorded preoperatively, at 6-weeks and 1-year post-operatively. The MCID was calculated using anchor-based methods (within-patient change; between-patient change; and receiver-operating characteristic approaches) and distribution-based methods (0.5 standard deviation (SD); effect size; standard error of measurement; standardized response mean; and 95% minimum detectable change (MDC)). The final MCID value was based on the “gold standard”: an averaging of the anchor-based methods using ODI and RMDQ as the closest available anchors. Results We prospectively recruited 134 patients. One-year follow-up was completed by 103 (76.8%) of patients. The MCID values derived using different methods varied from 0.7 to 5.1 s (s). The final, averaged, anchor-based MCID for improvement was 3.6 s. Within distribution-based methods, 95% MDC and 0.5SD approach, yielded an MCID of 3.0 and 3.8 s, respectively, aligning closely with the overall anchor-derived MCID for 5R-STS. Conclusion In a patient with LDH, an improvement in 5R-STS performance of at least 3.6 s can be regarded as a clinically relevant improvement.

PurposeMinimum clinically important difference (MCID) represents the smallest change in an outcome measure recognized as clinically meaningful to a patient and is one of the most important psychometric parameters for assessing the postoperative results of spinal surgery. The purpose of the present study was to elucidate MCIDs for four common outcome measures used for degenerative cervical myelopathy in the context of patients undergoing laminoplasty.MethodsWe retrospectively reviewed a consecutive series of cervical laminoplasties in a single academic institution. Pre- and postoperative Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ), Short Form-36 (SF-36), Neck Disability Index (NDI), and EuroQOL (EQ-5D) scores were obtained. Patients were also asked to answer the anchor question regarding satisfaction with treatment, and the anchor-based method was used to determine cut-off values for MCIDs.ResultsA total of 101 patients were included in the analysis. All outcome scores showed significant improvement postoperatively, with the exception of JOACMEQ bladder function score and SF-36 mental component summary score. Most patients (66%) were at least “somewhat satisfied” with treatment results. Receiver operating characteristic curve analyses revealed MCIDs of 2.5 for JOACEMQ cervical spine function, 13.0 for upper extremity function, 9.35 for lower extremity function, 9.5 for QOL, 3.9 for SF-36 physical component summary score, 4.2 for NDI, and 0.0485 for EQ-5D.ConclusionThe MCIDs of four outcome measures were determined for patients undergoing cervical laminoplasty.Graphical abstractThese slides can be retrieved under Electronic Supplementary Material.

Purpose To evaluate outcomes of choosing different Roussouly shapes and improving in Schwab modifiers for surgical Roussouly type 1 patients. Methods Baseline (BL) and 2-year (2Y) clinical data of adult spinal deformity (ASD) patients presenting with Roussouly type 1 sagittal spinal alignment were isolated in the single-center spine database. Patients were grouped into Roussouly type 1, 2 and 3 with anteverted pelvis (3a) postoperatively. Schwab modifiers at BL and 2Y were categorized as follows: no deformity (0), moderate deformity (+), and severe deformity (++) for pelvic tilt (PT), sagittal vertical axis (SVA), and pelvic incidence and lumbar lordosis mismatch (PI-LL). Improvement in SRS-Schwab was defined as a decrease in the severity of any modifier at 2Y. Results A total of 96 patients (69.9 years, 72.9% female, 25.2 kg/m 2 ) were included. At 2Y, there were 34 type 1 backs, 60 type 2 backs and only 2 type 3a. Type 1 and type 2 did not differ in rates of reaching 2Y minimal clinically important difference (MCID) for health-related quality of life (HRQOL) scores (all P >  0.05). Two patients who presented with type 3a had poor HRQOL scores. Analysis of Schwab modifiers showed that 41.7% of patients improved in SVA, 45.8% in PI-LL, and 36.5% in PT. At 2Y, patients who improved in SRS-Schwab PT and SVA had lower Oswestry disability index (ODI) scores and significantly more of them reached MCID for ODI (all P  < 0.001). Patients who improved in SRS-Schwab SVA and PI-LL had more changes of VAS Back and Short Form-36 (SF-36) outcomes questionnaire physical component summary (SF-36 PCS), and significantly more reached MCID (all P  < 0.001). By 2Y, type 2 patients who improved in SRS-Schwab grades reached MCID for VAS back and ODI at the highest rate ( P  = 0.003, P  = 0.001, respectively), and type 1 patients who improved in SRS-Schwab grades reached MCID for SF-36 PCS at the highest rate ( P  < 0.001). Conclusion For ASD patients classified as Roussouly type 1, postoperative improvement in SRS-Schwab grades reflected superior patient-reported outcomes while type 1 and type 2 did not differ in clinical outcomes at 2Y. However, development of type 3a should be avoided at the risk of poor functional outcomes. Utilizing both classification systems in surgical decision-making can optimize postoperative outcomes.

Introduction The minimal clinically important difference (MCID) is a valuable tool for patient-based outcome analysis, for which limited data is available in the literature, especially after arthroscopic rotator cuff repair (ARCR). Although several studies have reported MCID after ARCR, few have studied the impact of various clinical factors such as Diabetes, pseudoparalysis, type of cuff repair, and retear over MCID. This study attempts to determine the MCID in shoulder functional scores after ARCR and the impact of various factors on MCID. Methods 144 patients undergoing ARCR were prospectively evaluated at six and 12 months by ASES and UCLA scores. MCID for American Shoulder and Elbow Surgeons (ASES) and the University of California and Los Angeles (UCLA) scores were calculated using an anchor-based and distribution-based approach. MCID was also calculated for diabetic and non-diabetic patients, smokers vs. non-smokers, presence or absence of pseudoparalysis, type of cuff repair (single row vs. suture bridge), and presence of retears. Uni- and multivariate analysis was performed to identify factors affecting the MCID of both scores. Results Mean MCID for ASES score was 13.3 and 16.6 using an anchor-based and distribution-based approach, respectively. For the UCLA score, the mean MCID was 10.0 and 12.6 by anchor-based and 12.6 by distribution-based approach, respectively. Patients with higher pre-operative ASES scores demonstrated lower MCID values. No significant difference was observed in MCID scores of diabetic vs. non-diabetic patients, smoker vs. non-smoker, patients with or without pseudoparalysis, and type of cuff repair. The age, gender, and presence of retear did not affect MCID values. Conclusion This study establishes the MCID values of ASES and UCLA scores for rotator cuff repair by anchor and distribution methods. No patient or surgical factors appear to affect the MCID except pre-operative ASES scores. Study design Prospective cohort, Level II.

Background The previous study showed that the Mandarin Tinnitus Questionnaire (MTQ) has satisfactory reliability and validity. We have also completed the classification of the severity of tinnitus based on MTQ scores. In clinical studies, efficacy is often judged by whether results are statistically significant; however, statistical significance does not necessarily equate to clinical significance, whereas the minimum clinically important difference (MCID) of the scale does. In the following project, we will explore the MCID of the MTQ. Methods We recruited participants aged 18 years and above who sought treatment for primary or secondary tinnitus at the Otorhinolaryngology Department of the Hearing Center of West China Hospital, Sichuan University from September 2020 to September 2021. The participants had to undergo the following four assessments of tinnitus severity: doctor evaluation, self-report, the MTQ, and the visual analog scale (VAS), all at baseline and at the follow-up. The MCIDs of the MTQ were established via anchor-based and distribution-based methods. The anchor method used the VAS and self-reported clinical impression as anchors and defined the treatment effectiveness by mean/median and receiver operating characteristic (ROC) curve, while methods of effect size (ES), standard error of measurement (SEM), and reliability change index (RCI) were used in distribution-based methods. Results A total of 115 patients were investigated in this study, 57.4% of whom were women. The average age was 43.2 ± 13.20 years. The average MTQ and VAS scores at baseline were 31.3 ± 14.90 and 5.03 ± 2.24, respectively, while the average MTQ and VAS scores at follow-up were 15.9 ± 11.70 and 3.58 ± 2.48, respectively. Moreover, in terms of self-reported clinical impressions, 19 patients indicated that they were cured (16.5%), 24 that it was much better (20.9%), 63 that there was no change (54.8%), and 9 that it was much worse (7.8%). The MCIDs for the change in total MTQ ranged from 6.29 to 19.00, those for improvement from 1.09 to 22.75, and those for deterioration from 3.50 to 7.64. Conclusion We selected an absolute value of 7.5 as the MCID for the MTQ score. An increase in MTQ score more than 7.5 was considered aggravation of tinnitus, and a decrease in MTQ score more than 7.5 was considered a reduction in tinnitus.