Background: Clinician-reported outcome measures (ClinROMs) are frequently used in clinical trials and daily practice to evaluate the disease status and evolution of skin disorders. The minimal important difference (MID) represents the smallest difference that decreases the disease impact enough to make a treatment change worthwhile for patients. As no clear guidance exists on the preferred method to calculate MIDs for ClinROMs, we evaluated how the published values for different skin disorders should be interpreted. Methods: A systematic search was performed for MIDs of ClinROMs that focus on skin disorders and/or symptoms. The results of the questions in the credibility instrument for MIDs of Devji et al., 2020 were analyzed to gain insights into the meaning of these MIDs. Results: 29 MIDs were identified. The most common skin diseases were atopic dermatitis/eczema, followed by bullous disorders and psoriasis. A minimal important difference from the patients’ perspective was determined in 31% of the cases. However, in 41.4% of the cases, it concerned a substantial rather than a minimal difference in disease severity rated by physicians. Over half (55.1%) of the studies contained an inadequate number of patients (n < 150). MID values increased substantially in patients with severe compared to mild disease. Conclusions: MIDs of ClinROMs for skin disorders should be carefully interpreted due to the substantial differences in methodology between the studies. There is an urgent need for a consensus method to report reliable MIDs. Otherwise, this lack of uniformity could not only affect the design and conclusion of clinical trials but also skew treatment decisions.

The Michigan Hand outcomes Questionnaire (MHQ) is a widely used instrument to evaluate treatment results for hand conditions. Establishing the Minimally Important Change (MIC) is essential for interpreting change in outcome that is clinically relevant.
The purpose of this study was to determine the MIC of the MHQ total and subscale scores in patients undergoing trigger finger release.
This is a prospective cohort study conducted between December 2011 and February 2020.
Patients completed the MHQ prior to surgery and 3 months postoperatively. The MIC of the MHQ was determined using 5 anchor-based methods (ie, 2 anchor mean change methods and 3 receiver operating characteristic methods). The median MIC value was determined to represent the triangulated MIC.
A total of 1814 patients were included. The MIC for the MHQ total score ranged from 7.7 to 10.9, with a triangulated estimate of 9.3. The MIC estimates for 5 of 6 of the MHQ subscales ranged from 7.7 to 20.0. No MICs could be determined for the MHQ subscale \"aesthetics\" due to low correlations between the anchor questions and MHQ change scores.
These MIC estimates can contribute to the interpretation of clinical outcomes following trigger finger release and for assessment of power in prospective trials.

BACKGROUND: Evidence of health utility changes in patients who suffer from longstanding health complaints attributed to dental amalgam fillings are limited. The change in health utility outcomes enables calculating quality-adjusted life-year (QALY) and facilitates the comparison with other health conditions. The purpose of this study was to estimate the validity and responsiveness of the EQ-5D-5L and SF-6D utilities following removal of dental amalgam fillings in patients with health complaints attributed to their amalgam fillings, and examine the ability of these instruments to detect minimally important changes over time.
METHODS: Patients with medically unexplained physical symptoms, which they attributed to dental amalgam restorations, were recruited to a prospective cohort study in Norway. Two health state utility instruments, EQ-5D-5L and SF-6D, as well as self-reported general health complaints (GHC-index) and visual analogue scale (EQ-VAS) were administered to all patients (n = 32) at baseline and at follow-up. The last two were used as criteria measures. Concurrent and predictive validities were examined using correlation coefficients. Responsiveness was assessed by the effect size (ES), standardized response mean (SRM), and relative efficiency. Minimally important change (MIC) was examined by distribution and anchor-based approaches.
RESULTS: Concurrent validity of the EQ-5D-5L was similar to that of SF-6D utility. EQ-5D-5L was more responsive than SF-6D: the ES were 0.73 and 0.58 for EQ-5D-5L and SF-6D, respectively; SRM were 0.76 and 0.67, respectively. EQ-5D-5L was more efficient than SF-6D in detecting changes, but both were less efficient compared to criteria-based measures. The estimated MIC of EQ-5D-5L value set was 0.108 and 0.118 based on distribution and anchor-based approaches, respectively. The corresponding values for SF-6D were 0.048 and 0.064, respectively.
CONCLUSIONS: In patients with health complaints attributed to dental amalgam undergoing amalgam removal, both EQ-5D-5L and SF-6D showed reasonable concurrent and predictive validity and acceptable responsiveness. The EQ-5D-5L utility appears to be more responsive compared to SF-6D. Trial registration The research was registered at ClinicalTrials.gov., NCT01682278. Registered 10 September 2012, https://clinicaltrials.gov/ct2/show/NCT01682278 .

OBJECTIVE: To investigate the course of depressive symptoms, and basic and instrumental activities of daily living (collectively described as, (I)ADL functioning) from acute admission until one year post-discharge, the longitudinal association between depressive symptoms and (I)ADL functioning, and to disaggregate between- and within-person effects to examine whether changes in depressive symptoms are associated with changes in (I)ADL functioning.
METHODS: Prospective multicenter cohort of acutely hospitalized patients aged ≥70. Data gathered over a one-year period were assessed using validated measures of depressive symptoms (GDS-15) and physical functioning (Katz-ADL index). A Poisson mixed model analysis was used to examine the association between the courses and a hybrid model was used to disentangle between- and within-subject effects.
RESULTS: The analytic sample included 398 patients (mean age = 79.6 years, SD = 6.6). Results showed an improvement in depressive symptoms and physical functions over time, whereby changes in depressive symptoms were significantly associated with the course of ADL function (rate ratio (RR) = 0.91, p < .001) and IADL function (RR = 0.94, p < .001), even after adjustment for confounding variables. Finally, both between- and within-person effects of depressive symptoms were significantly associated with the course of ADL function (between-person: RR = 0.85, p < .001; within-person: RR = 0.94, p < .001) and IADL function (between-person: RR = 0.87, p < .001; within-person: RR = 0.97, p < .001).
CONCLUSIONS: The course of depressive symptoms and physical functions improved over time, whereby changes in depressive symptoms were significantly associated with changes in physical functions, both at group and individual level. These changes in (I)ADL functioning lie mostly above the estimated minimally important change for both scales, implying clinically relevant changes.

OBJECTIVE: Aim of this study was to evaluate the responsiveness of the Dutch version of the Achilles tendon Total Rupture Score (ATRS-NL).
METHODS: Patients (N = 47) completed the ATRS-NL at 3 and 6 months after Achilles tendon rupture (ATR). Additionally, they filled out the Euroqol-5D-5L (EQ-5D-5L) and Global Rating of Change Score (GRoC). Effect sizes (ES) and standardized response means (SRM) were calculated. The anchor-based method for determining the minimally important change (MIC) was used. GRoC and improvement on the items mobility and usual activities on the EQ-5D-5L served as external criteria. The scores on these anchors were used to categorize patients\' physical functioning as improved or unchanged between 3 and 6 months after ATR. Receiver operating curve (ROC) analysis was performed, with the calculation of the area under the ROC curve (AUC) and the estimation of MIC values using the optimal cut-off points.
RESULTS: There was a large change (ES: 1.58) and good responsiveness (SRM: 1.19) of the ATRS-NL between 3 and 6 months after ATR. Using ROC analysis, the MIC values ranged from 13.5 to 28.5 for reporting improvement on EQ-5D-5L mobility and GRoC, respectively. The AUC of improvement on mobility and improvement on GRoC were > 0.70.
CONCLUSIONS: The ATRS-NL showed good responsiveness in ATR patients between 3 and 6 months after injury. Use of this questionnaire is recommended in clinical follow-up and longitudinal research of ATR patients. MIC values of 13.5 and 28.5 are recommended to consider ATR patients as improved and greatly improved between 3 and 6 months after ATR.
METHODS: II.

We have previously developed and validated the Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ) for use across musculoskeletal care pathways, showing encouraging psychometric test results. The objective of this study was to determine the responsiveness of MSK-HQ following MSK treatments and to determine the minimally important change (MIC).
We collected data in four cohorts from community physiotherapy and secondary-care orthopaedic hip, knee and shoulder clinics.
592 individuals were recruited; 210 patients treated with physiotherapy for a range of MSK conditions in primary care; 150 patients undergoing hip replacement, 150 patients undergoing knee replacement and 82 undergoing shoulder surgery in secondary care.
Preoperative data were collected including the MSK-HQ, European Quality of Life-5D (EQ-5D) and the OHS, OKS or OSS in each joint-specific group. The same scores, together with anchor questions, were collected postintervention at 3 months for the physiotherapy group and 6 months for all others. Following COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) guidelines, responsiveness was assessed using correlation between scores and the MIC was calculated for the entire cohort using receiver operating characteristic curve analysis.
The MSK-HQ demonstrated strong correlation (R=0.73) with EQ-5D across the entire cohort and with each of the joint-specific Oxford scores (hip R=0.87, knee R=0.92 and shoulder R=0.77). Moderate correlation was seen between MSK-HQ and EQ-5D across each individual group (R value range 0.60-0.68), apart from the hip group where correlation was strong (R=0.77). The effect size with MSK-HQ was 0.93, in the entire cohort, double that measured with EQ-5D (0.43). In all subgroups, MSK-HQ measured a greater treatment effect compared with EQ-5D. The MIC is 5.5 (95% CI 2.7 to 8.3).
Our study demonstrates that the MSK-HQ questionnaire is responsive to change across a range of musculoskeletal conditions, supporting its use as a generic MSK measurement instrument.

The Roland Morris Disability Questionnaire (RMDQ), visual analog scale (VAS) of pain intensity, and numerical rating scale (NRS) are among the most commonly used outcome measures in trials of interventions for low back pain. Their use in paper form is well established. Few data are available on the metric properties of electronic counterparts.
The goal of our research was to establish responsiveness, minimally important change (MIC) thresholds, reliability, and minimal detectable change at a 95% level (MDC95) for electronic versions of the RMDQ, VAS, and NRS as delivered via iOS and Android apps and Web browser.
We recruited adults with low back pain who visited osteopaths. We invited participants to complete the eRMDQ, eVAS, and eNRS at baseline, 1 week, and 6 weeks along with a health transition question at 1 and 6 weeks. Data from participants reporting recovery were used in MIC and responsiveness analyses using receiver operator characteristic (ROC) curves and areas under the ROC curves (AUCs). Data from participants reporting stability were used for analyses of reliability (intraclass correlation coefficient [ICC] agreement) and MDC95.
We included 442 participants. At 1 and 6 weeks, ROC AUCs were 0.69 (95% CI 0.59 to 0.80) and 0.67 (95% CI 0.46 to 0.87) for the eRMDQ, 0.69 (95% CI 0.58 to 0.80) and 0.74 (95% CI 0.53 to 0.95) for the eVAS, and 0.73 (95% CI 0.66 to 0.80) and 0.81 (95% CI 0.69 to 0.92) for the eNRS, respectively. Associated MIC thresholds were estimated as 1 (0 to 2) and 2 (-1 to 5), 13 (9 to 17) and 7 (-12 to 26), and 2 (1 to 3) and 1 (0 to 2) points, respectively. Over a 1-week period in participants categorized as \"stable\" and \"about the same\" using the transition question, ICCs were 0.87 (95% CI 0.66 to 0.95) and 0.84 (95% CI 0.73 to 0.91) for the eRMDQ with MDC95 of 4 and 5, 0.31 (95% CI -0.25 to 0.71) and 0.61 (95% CI 0.36 to 0.77) for the eVAS with MDC95 of 39 and 34, and 0.52 (95% CI 0.14 to 0.77) to 0.67 (95% CI 0.51 to 0.78) with MDC95 of 4 and 3 for the eNRS.
The eRMDQ was reliable with borderline adequate responsiveness. The eNRS was responsive with borderline reliability. While the eVAS had adequate responsiveness, it did not have an attractive reliability profile. Thus, the eNRS might be preferred over the eVAS for measuring pain intensity. The observed electronic outcome measures\' metric properties are within the ranges of values reported in the literature for their paper counterparts and are adequate for measuring changes in a low back pain population.

OBJECTIVE: Multi-item questionnaires are frequently used to measure outcomes in randomized controlled trials (RCTs) in patients with sciatica. Knowing the minimaly important change (MIC) values for these instruments will facilitate interpretation of change scores. MIC values have been shown to be dependent on baseline values. The question is whether they also depend on the type of intervention. To estimate the MIC of the Roland Morris Disability Questionnaire (modified 23 item version) (RMDQ) and of intensity of leg pain measured by a Visual Analogue Scale (VAS) in patients with sciatica and to assess to what extent MIC values depend on type of intervention and on baseline values.
METHODS: This is a secondary analysis of RCT data of the effects of early surgery vs. prolonged conservative treatment in patients with sciatica. Baseline and 8-week data were used to assess MIC of the RMDQ-23 and VAS leg pain. We used the receiver operator characteristic (ROC) method to assess the MIC. Global Perceived Recovery (rated 8 weeks after baseline) was used as anchor. Subgroups were created based on type of treatment and baseline severity.
RESULTS: The MIC value of the RMDQ-23 for the total group of sciatica patients was 7.5. The values were 8.1 and 6.9 for surgery and conservative treatment, respectively. For high and low baseline values, the MICs were 9.0 and 4.9, respectively, irrespective of treatment received. The MIC values of the VAS leg pain were 34.4 for the total group. For surgery and conservative treatment, the MIC values were 38.5 and 30.4, respectively, whereas for groups with high and low baseline values, MIC values of 53.5 and 17.2 were found.
CONCLUSIONS: The MIC values of the RMDQ-23 and VAS leg pain were found to be highly dependent on their baseline values, although the type of intervention appeared to influence the MIC value only slightly.

The Seizure Severity Questionnaire (SSQ) was developed to evaluate changes in seizure severity and bothersomeness. Determination of a threshold value reflecting meaningful patient benefit on the SSQ would improve clinical interpretation of scale results. The objective of this analysis was to define a minimally important change (MIC) threshold for the SSQ, using data from patients with treatment-resistant partial-onset seizures from two clinical trials (N=776). Minimally important change thresholds were calculated using standard anchor-based methods, with the Patient Global Impression of Change (PGIC) score as the anchor with the categories of \'much improved,\' \'minimally improved,\' \'much worsened,\' and \'minimally worsened\' combined. The calculated MIC thresholds (range: 0.34 to 0.50) suggest that a 0.48-point change in the SSQ total score reflects a clinically meaningful change in seizure severity from the patients\' perspective.

OBJECTIVE: To interpret questionnaire scores, clinicians and researchers need to know what change in score reflects a meaningful change in the condition of an individual patient, and what difference reflects a meaningful difference between groups. These values differ between different populations. We determined the within-person minimally important change (MIC) and the between-group minimally important difference (MID) of the Headache Impact Test-6 (HIT-6) questionnaire in a primary-care population of migraine patients.
METHODS: We included 490 patients who participated in a clinical trial on the treatment of migraine in primary care. We compared their change scores on the HIT-6 questionnaire between baseline and at three-months follow-up with the answers to two anchor questions according to the \'mean change approach\' and the \'ROC curve approach\'.
RESULTS: The within-person MIC was estimated to be between -2.5 points (mean change approach) and -6 points (ROC curve approach). The choice for the within-person MIC value depends on the consequences of false positives and false negatives in a particular setting. The between-group MID was estimated at -1.5 points.
CONCLUSIONS: We determined the within-person MIC and between-group MID for the HIT-6 in a primary-care population of migraine patients. We recommend the use of these values for clinical care and for research.