Distribution-based Methods Research Articles

Poster 343: How Does the Literature on Minimum Clinically Important Difference (MCID) Apply to the Patient Population from a Single Center: The Challenge of MCID in Anterior Cruciate Ligament Reconstruction

Objectives: The field of orthopaedic surgery continues to transition towards using patient-reported outcome measures (PROMs) to measure treatment success. Metrics such as the minimum clinically important difference (MCID) can help define treatment success, but there is no clear consensus on the methodology or application of scores in clinical medicine. MCID calculations can vary significantly based on cohort size, methodology (e.g. anchor-based versus distribution-based methods), follow-up time point, and patient-specific factors. Anterior cruciate ligament reconstruction (ACLR) is a highly prevalent procedure that provides high patient satisfaction according to PROMs such as the Knee Injury & Osteoarthritis Outcome Score (KOOS) and the Single Assessment Numerical Evaluation (SANE). Both scales have MCID values reported in the ACLR literature. The purpose of this study was to identify patients that reached the literature-reported MCID values for KOOS and SANE. The secondary aim was to identify if there were any differences in demographic, injury, and treatment characteristics among patients that reach MCID for KOOS and/or SANE and those that do not. Methods: The PROM database of a single ambulatory surgical center was queried for ACLR procedures from 2009-2016. Revision procedures, concomitant ligament repairs/reconstructions, and patients without outcome data at baseline and two-year follow-up were excluded from the study. Demographic, injury, and surgical characteristics were extracted via chart review. Demographics included age, sex, and diagnosis of anxiety and/or depression. Injury characteristics included acuity of injury (≥6 months considered chronic) and presence of meniscal injuries. Surgical characteristics included body mass index (BMI), operative time, American Society of Anesthesiologists (ASA) Score, graft type, implant type, and concomitant meniscal procedures. Outcomes evaluated were KOOS and SANE after two years of ACLR. Patients were grouped according to whether they did or did not meet literature-reported MCIDs for KOOS and/or SANE. One-way analysis of variance and chi-square tests were conducted to identify group differences, with p=0.05 set as the threshold for significance. Results: A total of 322 patients were included. Most were female (62.1%) and had an average age of 28. Average BMI and operative time were 25.3 and 108.3 minutes, respectively. Most patients had an ASA score of 1 (84.1%). A total of 20.5% of patients had a mental health diagnosis of anxiety and/or depression. Most patients received a bone-tendon-bone autograft (49.1%). Only 6.8% of patients presented with a chronic injury. The proportion of patients that achieved MCID at two years for KOOS and SANE were 73.6% and 45.7%, respectively (p<0.00001). The majority of patients achieving SANE MCID achieved KOOS MCID (89.8%), while just 55.7% of patients achieving KOOS MCID achieved SANE MCID. 41.0% of patients achieved MCID for both KOOS and SANE, while 21.7% of patients did not achieve MCID for any scale. Compared to patients that achieved MCID in at least one PROM, there was a significantly higher proportion of patients that underwent ACLR for chronic injuries among those that did not meet MCID (11.4% vs 5.6%, p=0.004). Surgical technique did not statistically differ among patients that achieved MCID and those that did not. Conclusions: The rates of achieving literature-reported MCID values for KOOS and SANE were significantly different within the same cohort of ACLR patients (73.6% for KOOS vs 45.7% for SANE). Only 41.0% of patients achieved MCID for both PROMs. A higher percentage of patients that did not meet MCID had chronic injuries compared to those that met at least one MCID. Treatment success in ACLR as determined by PROMs is thus a function of the tool employed and the injury/patient undergoing treatment rather than the surgery performed. This study particularly found that the timing from injury to presentation was associated with likelihood of achieving MCID. As orthopaedics continues to incorporate PROM data to determine treatment success as well as prior authorization and reimbursement policies, it is important to refine these PROMs and tailor them to patient-specific factors in order to adequately capture a successful treatment. [Table: see text][Table: see text]

Quantifying Threshold Scores for Patient Satisfaction After Massive Rotator Cuff Repair for the Interpretation of Mid-Term Patient-Reported Outcomes

To establish minimal clinically important difference (MCID) and patient acceptable symptomatic state (PASS) values for 4 patient-reported outcomes (PROs) in patients undergoing arthroscopic massive rotator cuff repair (aMRCR): American Shoulder and Elbow Surgeons (ASES) score, Subjective Shoulder Value (SSV), Veterans Rand-12 (VR-12) score, and the visual analog scale (VAS) pain. In addition, our study seeks to determine preoperative factors associated with achieving clinically significant improvement as defined by the MCID and PASS. A retrospective review at 2 institutions was performed to identify patients undergoing aMRCR with minimum 4-year follow-up. Data collected at the 1-year, 2-year, and 4-year time points included patient characteristics (age, sex, length of follow-up, tobacco use, and workers' compensation status), radiologic parameters (Goutallier fatty infiltration and modified Collin tear pattern), and 4 PRO measures (collected preoperatively and postoperatively): ASES score, SSV, VR-12 score, and VAS pain. The MCID and PASS for each outcome measure were calculated using the distribution-based method and receiver operating characteristic curve analysis, respectively. Pearson and Spearman coefficient analyses were used to determine correlations between preoperative variables and MCID or PASS thresholds. A total of 101 patients with a mean follow-up of 64 months were included in the study. The MCID and PASS values at the 4-year follow-up for ASES were 14.5 and 69.4, respectively; for SSV, 13.7 and 81.5; for VR-12, 6.6 and 40.3; and for VAS pain, 1.3 and 1.2. Greater infraspinatus fatty infiltration was associated with failing to reach clinically significant values. This study defined MCID and PASS values for commonly used outcome measures in patients undergoing aMRCR at the 1-year, 2-year, and 4-year follow-up. At mid-term follow-up, greater preoperative rotator cuff disease severity was associated with failure to achieve clinically significant outcomes. Level IV, case series.

Adjuvant Arthroscopy Does Not Improve the Functional Outcome of Volar Locking Plate for Distal Radius Fractures: A Randomized Clinical Trial

To evaluate the outcomes of adding arthroscopy to osteosynthesis of distal radius fractures (DRF) with volar locking plate (VLP), by Patient-Rated Wrist Evaluation (PRWE) 1 year after surgery. In total, 186 functionally independent adult patients who met the inclusion criteria (DRF and a clinical decision for surgery with a VLP) were randomized to arthroscopic assistance or not. Primary outcome was PRWE questionnaire results 1 year after surgery. For the main variable, PRWE, we obtained the minimal clinically important difference based on a distribution-based method. Secondary outcomes included Disabilities of the Arm, Shoulder and Hand and 12-Item Short Form Health Survey questionnaires, range of motion, strength, radiographic measures, and presence of joint step-offs by computed tomography. Data were collected preoperatively and at+1 and+4 weeks,+3 and+6 months, and+1 year after surgery. Complications were recorded throughout the study. In total, 180 patients (mean age: 59.0 ± 14.9 years; 76% women) were analyzed by modified intention to treat. A total of 82% of the fractures were intra-articular (AO type C). No significant difference between arthroscopic (AG) and control (CG) groups in median PRWE was found at+1 year (median AG: 5.0, median CG: 7.5, difference in medians 2.5; 95% confidence interval [CI] -2.0, 7.0, P= .328). The proportion of patients who exceeded the minimal clinically important difference of 12.81 points in the AG and CG was 86.4% vs 85.1%, P= .819, respectively. Percentage of associated injuries and step-offs reduction maneuvers was greater with arthroscopy (mean differences: 17.1 95% CI -0.1, 26.1, P < .001) and 17.4 (95% CI 5.0, 29.7, P= .007). The difference in percentage of residual joint step-offs at the postsurgical computed tomography in radioulnar, radioscaphoid, and radiolunate joints was not significant (P= .990, P= .538, and P= .063). Complications were similar between groups (16.9% vs 20.9%, P= .842). Adjuvant arthroscopy did not significantly improve PRWE score+1 year after surgery for DRF with VLP, although the statistical power of the study is below the initially estimated to detect the expected difference. Level I, randomized controlled trial.

Psychometric Validation and Meaningful Change Thresholds of the New Nasal Polyposis Symptom Diary.

The Nasal Polyposis Symptom Diary (NPSD) is a novel and short patient-reported outcome (PRO) tool specifically developed to assess important and relevant symptoms reported by patients with chronic rhinosinusitis with nasal polyposis (CRSwNP). We evaluated the psychometric properties of 4 predefined NPSD-derived scores intended to support symptom-improvement assessments of investigational therapies for inclusion in product labeling. Five hundred eighteen patients with severe CRSwNP from a Phase III clinical trial (NCT03401229) completed the NPSD, comprising 11 items: 8 symptom-specific, 2 symptom-impact, and 1 optional medication-compliance. The psychometric characteristics of 3 single-item symptom scores (Nasal Blockage Score [NBS], Nasal Congestion Score [NCS], and Difficulty with Sense of Smell Score [DSS]) and a Total Symptom Score (TSS, summary of the 8 symptom-specific items) were evaluated for reliability, validity, and ability to detect change. Within-patient meaningful change thresholds (MCTs) were established using anchor- and distribution-based methods. Comparative PROs included the 22-item Sino-Nasal Outcome Test (SNOT-22) and Patient Global Impression of Severity (PGI-S). The TSS exhibited strong internal consistency (Cronbach α = .88) and test-retest reliability (intraclass correlation coefficient >.80). Correlation between the TSS and SNOT-22 total score indicated good convergent validity (r = .70). All 4 NPSD scores demonstrated known-groups validity (significant differences among subgroups of patients with predetermined disease severity levels based on PGI-S categories) and were sensitive to detect change in patients' clinical status (significant differences among subgroups of patients with reported changes between 2 time-points in PGI-S and Patient Global Impression of Change scores). MCTs for improvement were established at 1.0 point for NBS, NCS, and DSS, and 4.0 points for TSS. These findings support the reliability, validity, and suitability of the 4 NPSD-derived scores for evaluating treatment effect on CRSwNP symptoms and their use in clinical trials with predetermined MCTs for improvement.

Assessing Common Content and Responsiveness of the QoR-15 and the SF-8 in the Context of Recovery from Regional Anesthesia for Joint Replacement.

There is no consensus regarding how best to measure postoperative quality of recovery after anesthesia/surgery (e.g., using 24-hour survey instruments) in veterans or active military. Our goals were to (1) describe health-related quality-of-life (HRQoL) and recovery across time in veterans, (2) examine the commonality between the quality of recovery (QoR-15) and short-form (SF) surveys (including the SF-8, 24-hour version), and (3) examine the responsiveness of these surveys. This study was approved by the Institutional Review Boards from the University of Pittsburgh, the VA Pittsburgh, and the Human Research Protection Office of the Department of Defense. Secondary analyses of data were executed based on a randomized trial dataset of knee/hip arthroplasty patients, the study having recruited 135 total veterans. QoR-15 and HRQoL SF surveys were completed and self-reported before surgery (pre-op), on postoperative day 2 (PO-D2), and 6 weeks postoperatively. Descriptive statistics were used to examine scores across time. Common content was examined using Pearson's r. Responsiveness was examined using distribution-based methods. Average veteran age was 67 year, 89% were male, 88% white, and average body mass index was 33 kg∙m-2. QoR-15 scores declined from pre-op to PO-D2 but were higher than pre-op at 6 weeks. SF physical component summary (PCS) scores were low both pre-op and PO-D2, but were elevated over baseline at 6 weeks. SF mental component summary (MCS) scores declined from baseline to PO-D2 but were higher than pre-op at 6 weeks. Associations of the QoR-15 total score and PCS/MCS were medium/large and statistically significant at P ≤ .01. Both instruments were responsive to changes. QoR-15 and SF-8 have high content commonality and performed similarly in veterans across time. SF-8 has added benefits of (1) brevity, (2) assessment of physical and mental health components, and (3) being normed to the general population. The SF-8, if used without the QoR-15 in tandem in future study of anesthesia-related outcomes, would need to be supplemented by separate questions addressing postoperative nausea/vomiting (a frequent outcome after anesthesia that is relevant to same-day and next-day mobilization after elective joint replacement surgery).

Establishing minimal clinically important differences for the Quality of Life Instrument of Chronic Gastritis QLICD-CG(V2.0) based on distribution-based methods

BackgroundTo establish the lowest score reflecting meaningful changes from the perspective of patients is very important for explaining the results of patient reports. The measurement scale of quality of life in patients with chronic gastritis has been used in clinical practice, but the minimal clinically important difference (MCID) has not been worked out. In this paper, we use a distribution-based method to calculate the MCID of the scale QLICD-CG (Quality of Life Instruments for Chronic Diseases- Chronic Gastritis) (V2.0).MethodsThe QLICD-CG(V2.0) scale was used to evaluate the quality of life in patients with chronic gastritis. Since the methods for developing MCID were diverse and there was no uniform standard, we took MCID developed by anchor-based method as the gold standard, and compared the MCID of QLICD-CG(V2.0) scale developed by various distribution-based methods for selection. Standard deviation method (SD), effect size method (ES), standardized response mean method (SRM), standard error of measurement method (SEM) and reliable change index method (RCI) are given in the distribution-based methods.ResultsA total of 163 patients, with an average age of (52.37 ± 12.96) years old, were calculated according to the various methods and formulas given by the distribution-based method, and the results were compared with the gold standard. It was suggested that the results of the SEM method at the moderate effect (1.96) should be taken as the preferred MCID of the distribution-based method. And thus the MCID of the physical domain, psychological domain, social domain, general module, specific module and total score of the QLICD-CG(V2.0) scale were 9.29, 13.59, 9.27, 8.29, 13.49 and 7.86, respectively.ConclusionsWith anchor-based method as the gold standard, each method in distribution-based method has its own advantages and disadvantages. In this paper, 1.96SEM was found to have a good effect on the minimum clinically significant difference of the QLICD-CG(V2.0) scale, and it is recommended as the preferred method to establish MCID.

Prevalence, Severity, and Co-Occurrence of SPPADE Symptoms in 31,866 Patients With Cancer.

To examine the prevalence, severity, and co-occurrence of SPPADE symptoms as well as their association with cancer type and patient characteristics. The SPPADE symptoms (sleep disturbance, pain, physical function impairment, anxiety, depression, and low energy /fatigue) are prevalent, co-occurring, and undertreated in oncology and other clinical populations. Baseline SPPADE symptom data were analyzed from the E2C2 study, a stepped wedge pragmatic, population-level, cluster randomized clinical trial designed to evaluate a guideline-informed symptom management model targeting the six SPPADE symptoms. Symptom prevalence and severity were measured with a 0-10 numeric rating (NRS) scale for each of the six symptoms. Prevalence of severe (NRS ≥ 7) and potential clinically relevant (NRS ≥ 5) symptoms as well as co-occurrence of clinical symptoms were determined. Distribution-based methods were used to estimate the minimally important difference (MID). Associations of cancer type and patient characteristics with a SPPADE composite score were analyzed. A total of 31,886 patients were assessed for SPPADE symptoms prior to, during, or soon after an outpatient medical oncology encounter. The proportion of patients with a potential clinically relevant symptom ranged from 17.5% for depression to 33.4% for fatigue. Co-occurrence of symptoms was high, with the proportion of patients with three or more additional clinically relevant symptoms ranging from 45.2% for fatigue to 68.6% for depression. The summed SPPADE composite score demonstrated good internal reliability (Cronbach's alpha of 0.86), with preliminary MID estimates of 4.1-4.3. Symptom burden differed across several types of cancer but was generally similar across most sociodemographic characteristics. The high prevalence and co-occurrence of SPPADE symptoms in patients with all types of cancer warrants clinical approaches that optimize detection and management.

Mood disorder in idiopathic pulmonary fibrosis: response to pulmonary rehabilitation.

Pulmonary rehabilitation improves mood disorder in COPD, but there are limited data in idiopathic pulmonary fibrosis (IPF). The aims of this cohort study were to investigate whether pulmonary rehabilitation reduces mood disorder in IPF, and estimate the minimal important difference (MID) of the Hospital Anxiety and Depression Scale (HADS). HADS and core pulmonary rehabilitation outcomes were measured in 166 participants before and after an 8-week, in-person, outpatient pulmonary rehabilitation programme. Anchor- and distribution-based methods were used to calculate the MID of HADS-Anxiety (A) and HADS-Depression (D). Suggestive or probable anxiety and depression (HADS ≥8) were present in 35% and 37% of participants, respectively, at baseline, and this reduced significantly following pulmonary rehabilitation (post-pulmonary rehabilitation: HADS-A 23%, HADS-D 26%). Overall, there was a significant reduction in HADS-D (mean change -1.1, 95% CI -1.6- -0.5), but not HADS-A (-0.6, -1.3-0.15) with pulmonary rehabilitation. Subgroup analysis of those with HADS ≥8 revealed significant improvements in HADS domains (mean change: HADS-A -4.5, 95% CI -5.7- -3.4; median change: HADS-D -4.0, interquartile range -6.0- -1.0). The mean (range) MID estimates for HADS-A and HADS-D were -2 (-2.3- -1.7) and -1.2 (-1.9- -0.5), respectively. In people with IPF and suggestive or probable mood disorder, pulmonary rehabilitation reduces anxiety and depression.

The minimal clinically important difference of app‐based electronic patient‐reported outcomes for hay fever

Hay fever is a common allergic disease, with an estimated worldwide prevalence of 14.4% and a variety of symptoms. This study assessed the minimal clinically important difference (MCID) of nasal symptom score (NSS), non-nasal symptom score (NNSS), and total symptoms score (TSS) for app-based hay-fever monitoring. MCIDs were calculated based on the data from a previous large-scale, crowdsourced, cross-sectional study using AllerSearch, an in-house smartphone application. MCIDs were determined with anchor-based and distribution-based methods. The face scale score of the Japanese Allergic Conjunctival Disease Standard Quality of Life Questionnaire Domain III and the daily stress level due to hay fever were used as anchors for determining MCIDs. The MCID estimates were summarized as MCID ranges. A total of 7590 participants were included in the analysis (mean age: 35.3years, 57.1% women). The anchor-based method produced a range of MCID values (median, interquartile range) for NSS (2.0, 1.5-2.1), NNSS (1.0, 0.9-1.2), and TSS (2.9, 2.4-3.3). The distribution-based method produced two MCIDs (based on half a standard deviation, based on a standard error of measurement) for NSS (2.0, 1.8), NNSS (1.3, 1.2), and TSS (3.0, 2.3). The final suggested MCID ranges for NSS, NNSS, and TSS were 1.8-2.1, 1.2-1.3, and 2.4-3.3, respectively. MCID ranges for app-based hay-fever symptom assessment were obtained from the data collected through a smartphone application, AllerSearch. These estimates may be useful for monitoring the subjective symptoms of Japanese patients with hay fever through mobile platforms.

Scale-invariant sensitivity for multi-purpose water reservoirs management with temporal scale-dependent modeling

High-resolution temporal data (e.g., daily) is valuable for the decision-making of water resources management because it more accurately captures fine-scale processes and extremes than the coarse temporal data (e.g., weekly or monthly). However, many studies rarely consider this superior suitability for water resource modeling and management; instead, they often use whichever data is more readily available. So far, no comparative investigations have been conducted to determine if access to different time-scale data would change decision-maker perceptions or the rationality of decision making. This study proposes a framework for assessing the impact of different temporal scales on water resource management and the performance objective's sensitivity to uncertainties. We built the multi-objective operation models and operating rules of a water reservoir system based on daily, weekly, and monthly scales, respectively, using an evolution multi-objective direct policy search. The temporal scales of the input variables (i.e., streamflow) affect both the model structures and the output variables. In exploring these effects, we reevaluated the temporal scale-dependent operating rules under uncertain streamflow sets generated from synthetic hydrology. Finally, we obtained the output variable's sensitivities to the uncertain factors at different temporal scales using the distribution-based sensitivity analysis method. Our results show that water management based on too coarse resolution might give decision makers the wrong perception because the effect of actual extreme streamflow process on the performance objectives is ignored. The streamflow uncertainty is more influential than the uncertainty associated with operating rules. However, the sensitivities are characterized by temporal scale invariance, as the differences of the sensitivity between different temporal scales are not obvious over the uncertainties in streamflow and thresholds. These results show that water management should consider the resolution-dependent effect of temporal scales for balancing modeling complexity and computational cost.

Minimum Clinically Important Difference in Patient-reported Outcome Measures in de novo Degenerative Lumbar Scoliosis: Is it Appropriate to Apply the Values of Adult Spine Deformity?

A retrospective analysis. The objective of this study was to calculate the range of minimum clinically important difference threshold values using anchor-based and distribution-based methods for back pain, leg pain, the Oswestry Disability Index (ODI), and the Scoliosis Research Society 22R instrument (SRS-22R) in patients with de novo degenerative lumbar scoliosis (DNDLS) who underwent long-segment fusion surgery. Then, we sought to determine a statistically sound meaningful, minimum clinically important difference in patient-reported outcome measures (PROMs) and compare our results with previously reported values for other adult spine deformity (ASD) populations. Minimum clinically important difference thresholds for back pain, leg pain, and the ODI and SRS-22R have not been widely described in patients with ASD. PROMs were obtained preoperatively and two years postoperatively in 128 patients with DNDLS. We applied different minimum clinically important difference calculation methods to the data, and the results were compared. There was a statistically significant improvement in the two-year postoperative PROM scores compared with the preoperative scores. Different preoperative calculation methods yielded an ~10-fold range of values. Minimum clinically important difference values were established as 1.9 for back pain, 1.5 for leg pain, 18.9 for the ODI, 0.8 for SRS-22R pain, 0.5 for SRS-22R activity, 1.6 for SRS-22R appearance, 0.8 for SRS-22R mental, and 0.98 for the SRS-22R subtotal. Compared with the previously reported minimum clinically important differences in ASD, the values for back pain, ODI, and SRS-22R appearance were higher in patients with DNDLS. Sensitivity-based and specificity-based methods provide statistically sound minimum clinically important difference thresholds for the DNDLS population. The minimum clinically important difference thresholds for PROMs in patients with DNDLS were different from the threshold values previously reported for adult patients with spinal deformities.

Distribution-based maximum likelihood estimation methods are preferred for estimating Salmonella concentration in chicken when contamination data are highly left-censored

Salmonella is a common chicken-borne pathogen that causes human infections. Data below the detection limit, referred to as left-censored data, are frequently encountered in the detection of pathogens. The approach of handling the censored data was regarded to affect the estimation accuracy of microbial concentration. In this study, a set of Salmonella contamination data was collected from chilled chicken samples using the most probable number (MPN) method, which consisted of 90.42% (217/240) non-detect values. Two simulated datasets with fixed censoring degrees of 73.60% and 90.00% were generated based on the real-sampling Salmonella dataset for comparison. Three methodologies were applied for handling left-censored data: (i) substitution with different alternatives, (ii) the distribution-based maximum likelihood estimation (MLE) method, and (iii) the multiple imputation (MI) method. For each dataset, the negative binomial (NB) distribution-based MLE and zero-modified NB distribution-based MLE were preferable for highly censored data and resulted in the least root mean square error (RMSE). Replacing the censored data with half the limit of quantification was the next best method. The mean concentration of Salmonella monitoring data estimated by the NB-MLE and zero-modified NB-MLE methods was 0.68 MPN/g. This study provided an available statistical method for handling bacterial highly left-censored data.

Propensity for Clinically Meaningful Improvement and Surgical Failure After Anterior Cruciate Ligament Repair.

Primary repair of the anterior cruciate ligament (ACL) confers an alternative to ACL reconstruction in appropriately selected patients. To prospectively assess survivorship and to define the clinically meaningful outcomes after ACL repair. Case series; Level of evidence, 4. Included were consecutive patients with Sherman grade 1-2 tears who underwent primary ACL repair with or without suture augmentation between 2017 and 2019. Patient-reported outcomes (Lysholm, Tegner, International Knee Documentation Committee, Western Ontario and McMaster Universities Osteoarthritis Index, and Knee injury and Osteoarthritis Outcome Score [KOOS] subscales) were collected preoperatively and at 6 months, 1 year, and 2 years postoperatively. The minimal clinically important difference (MCID) was calculated using a distribution-based method, whereas the Patient Acceptable Symptom State (PASS) and substantial clinical benefit (SCB) were calculated using an anchor-based method. Plain radiographs and magnetic resonance imaging (MRI) were obtained at 6 months, 1 year, and 2 years postoperatively. A total of 120 patients were included. The overall failure rate was 11.3% at 2 years postoperatively. Changes in outcome scores required to achieve the MCID ranged between 5.1 and 14.3 at 6 months, 4.6 and 8.4 at 1 year, and 4.7 and 11.9 at 2 years postoperatively. Thresholds for PASS achievement ranged between 62.5 and 89 at 6 months, 75 and 89 at 1 year, and 78.6 and 93.2 at 2 years postoperatively. Threshold scores (absolute/change based) for achieving the SCB ranged between 82.8 and 96.4/17.7 and 40.1 at 6 months, between 94.7 and 100/23 and 45 at 1 year, and between 95.3 and 100/29.4 and 45 at 2 years. More patients achieved the MCID and PASS at 1 year compared with 6 months and 2 years. For SCB, this trend was also observed for non-KOOS outcomes, while for KOOS subdomains, more patients achieved the SCB at 2 years. High-intensity signal of the ACL repair (odds ratio [OR], 31.7 [95% CI, 1.5-73.4]; P = .030) and bone contusions on MRI (OR, 4.2 [95% CI, 1.7-25.2]; P = .041) at 1 year postoperatively were independently associated with increased risk of ACL repair failure. The rate of clinically meaningful outcome improvement was high early after ACL repair, with the greatest proportion of patients achieving the MCID, PASS, and SCB at 1 year postoperatively. Bone contusions involving the posterolateral tibia and lateral femoral condyle as well as high repair signal intensity at 1 year postoperatively were independent predictors of failure at 2 years postoperatively.

Studies in the Falls Efficacy Scale-International for patients with cervical compressive myelopathy: Reliability, validity, and minimum clinically important difference

Context Patients with cervical compressive myelopathy (CCM) often complain of body balance problems, such as fear of falling and bodily unsteadiness. However, no accepted patient-reported outcome measures (PROMs) for this symptomatology exist. The Falls Efficacy Scale-International (FES-I) is one of the most widely used PROMs for evaluating impaired body balance in various clinical fields. Objective To examine reliability, validity, and minimum clinically important difference (MCID) of the FES-I for the evaluation of impaired body balance in patients with CCM. Methods Patients who underwent surgery for CCM were retrospectively reviewed. The FES-I was administered preoperatively and at 1 year postoperatively. Further, cJOA-LE score (subscore for lower extremities in the Japanese Orthopaedic Association score for cervical myelopathy) and stabilometric data, obtained at the same time points of the FES-I administration, were analyzed. Reliability was examined through internal consistency with Cronbach’s alpha. Convergent validity was studied using correlation analysis. The MCID was estimated using anchor- and distribution-based methods. Results Overall, 151 patients were included for analysis. Cronbach’s alpha coefficient was the acceptable value of 0.97 at both baseline and 1 year postoperatively. As for convergent validity, the FES-I had significant correlations with the cJOA-LE score and stabilometric parameters both at baseline and 1 year postoperatively. The MCID calculated using anchor- and distribution-based methods was 5.5 and 10, respectively. Conclusion FES-I is a reliable and valid PROM to evaluate body balance problems for the CCM population. The established thresholds of MCID can help clinicians recognize the clinical significance of changes in patient status.

Establishing Minimum Clinically Important Difference Thresholds for Physical Function and Pain in Patients Undergoing Anterior Lumbar Interbody Fusion

To establish minimum clinically important difference (MCID) in anterior lumbar interbody fusion (ALIF) for the physical function patient-reported outcome measures, Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS-PF), 12-Item Short Form (SF-12) physical component score (PCS), Veterans RAND 12 (VR-12) PCS, and pain patient-reported outcome measures visual analog scale (VAS) back and VAS leg through anchor- and distribution-based calculations. Patients undergoing ALIF with preoperative and 6-month Oswestry Disability Index were included. Using Oswestry Disability Index as the anchor, anchor-based calculation methods were the average change, minimum detectable change, and receiver operating characteristic curve methods. Distribution-based methods were the standard error of measurement, reliable change index, effect size, and half of the standard deviation (0.5ΔSD). Fifty-one patients were identified. Anchor-based methods ranged from 2.9 to 11.5 for PROMIS-PF, 8.2-13.6 for SF-12 PCS, 7.8-16.8 for VR-12 PCS, 0.5-3.9 for VAS back, and 1.0-3.4 for VAS leg. The area under curve ranged from 0.59 (VAS back) to 0.78 (VR-12 PCS). Distribution-based methods ranged from 1.0 to 4.2 for PROMIS-PF, 1.8-12.2 for SF-12 PCS, 1.9-6.2 for VR-12 PCS, 0.4-1.6 for VAS back, and 0.5-1.7 for VAS leg. The MCID values greatly relied on the calculation method. The minimum detectable change method was selected as the most appropriate MCID calculation method. The MCID values that may be utilized for ALIF patients are 7.3 for PROMIS-PF, 8.2 for SF-12 PCS, 7.8 for VR-12 PCS, 3.2 for VAS back, and 2.2 for VAS leg.

Establishing minimal detectable change thresholds for the international knee documentation committee and Kujala scores at one and two years after patellofemoral joint arthroplasty.

To define the minimal detectable change (MDC) for the international knee documentation committee (IKDC) and Kujala scores one and two years after patellofemoral joint arthroplasty (PFA). A distribution-based method (one-half the standard deviation of the mean difference between postoperative and preoperative outcome scores) was applied to establish MDC thresholds among 225 patients undergoing primary PFA at a single high-volume musculoskeletal-care center. Stability of change in MDC achievement was explored by quantifying the proportion of achievement at one- and two-year postoperative timepoints. Multivariable logistic regression analysis was performed to explore the association between sociodemographic and operative features on MDC achievement. MDC thresholds for the Kujala score were 10.3 (71.1% achievement) and 10.6 (70.4% achievement) at one- and two years, respectively. The MDC thresholds for the IKDC score were 11.2 (78.1% achievement) and 12.3 (69.0% achievement) at one- and two years, respectively. Predictors of achieving the MDC for the Kujala and IKDC scores at both time points were lower preoperative Kujala and IKDC scores, respectively. Preoperative thresholds of ≤ 24.1 and 7.6 for the Kujala and IKDC scores, respectively, were associated with a 90% MDC achievement probability. When preoperative thresholds approached 64.3 and 48.3 for the Kujala and IKDC, respectively, MDC achievement probability reduced to 50%. The MDC thresholds for the Kujala and IKDC scores two years after PFA were 10.6 and 12.3, respectively. Clinically significant health status changes were maintained overall, with a slight decrease in achievement rates between one and two years. MDC achievement was associated with disability at presentation, and several probability-based preoperative thresholds were defined. These findings may assist knee surgeons with patient selection and the decision to proceed with PFA by better understanding the patient-specific propensity for MDC achievement. IV, retrospective case series.

Responsiveness and minimal clinically important difference of EQ-5D-5L in patients with coronary heart disease after percutaneous coronary intervention: A longitudinal study.

Although the five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L) has been validated in various diseases, no empirical study has evaluated the responsiveness and minimal clinically important difference (MCID) of the instrument in patients with coronary heart disease (CHD), which limits the interpretability and clinical application of EQ-5D-5L. Therefore, this study aimed to determine the responsiveness and MCID of EQ-5D-5L in patients with CHD who underwent percutaneous coronary intervention (PCI) and identify the relationship between the MCID values and minimal detectable change (MDC). Patients with CHD were recruited for this longitudinal study at the Tianjin Medical University's General Hospital in China. At baseline and 4 weeks after PCI, participants completed the EQ-5D-5L and Seattle Angina Questionnaire (SAQ). Additionally, we used the effect size (ES) to assess the responsiveness of EQ-5D-5L. The anchor-based, distribution-based, and instrument-based methods were used in this study to calculate the MCID estimates. The MCID estimates to MDC ratios were computed at the individual and group levels at a 95% CI. Seventy-five patients with CHD completed the survey at both baseline and follow-up. The EQ-5D-5L health state utility (HSU) improved by 0.125 at follow-up compared with baseline. The ES of EQ-5D HSU was 0.850 in all patients and 1.152 in those who improved, indicating large responsiveness. The average (range) MCID value of the EQ-5D-5L HSU was 0.071 (0.052-0.098). These values can only be used to determine whether the change in scores were clinically meaningful at the group level. EQ-5D-5L has large responsiveness among CHD patients after undergoing PCI surgery. Future studies should focus on calculating the responsiveness and MCID for deterioration and examining the health changes at the individual level in CHD patients.

Demystifying the Value of Minimal Clinically Important Difference in the Cardiothoracic Surgery Context.

The aim of this review is to describe the different statistical methods used in estimating the minimal clinically important difference (MCID) for the assessment of quality of life (QOL)-related and clinical improvement interventions, along with their implementation in cardiothoracic surgery. A thorough literature search was performed in three databases (PubMed/Medline, Scopus, Google Scholar) for relevant articles from 1980 to 2022. We included articles that implemented and assessed statistical methods used to estimate the concept of MCID in cardiothoracic surgery. MCID has been successfully implemented in several medical specialties. Anchor-based and distribution-based methods are the most common approaches when evaluating the MCID. Nonetheless, we found only five studies investigating the MCID in the context of cardiothoracic surgery. Four of them used anchor-based approaches, and one used both anchor-based and distribution-based methods. MCID values were very variable depending on the methods applied, as was the clinical context of the study. The variables of interest were certain QOL measuring questionnaires, used as anchors. Multiple anchors and methods were applied, leading to different estimations of MCID. Since cardiothoracic surgery is related to important perioperative morbidity, MCID might represent an important and efficient adjunct tool to interpret clinical outcomes. The need for MCID methodology implementation is even higher in patients with heart failure undergoing cardiac surgery. More studies are needed to validate different MCID methods in this context.

Determining minimal important differences for patient-reported outcome measures in shoulder, lateral elbow, patellar and Achilles tendinopathies using distribution-based methods

BackgroundMinimal important difference (MID) is a concept used inconsistently and arbitrarily in tendinopathy research. Our aim was to determine the MIDs for the most commonly used tendinopathy outcome measures using data-driven approaches.MethodsRecently published systematic reviews of randomised controlled trials (RCTs) on tendinopathy management were identified and used for extraction of eligible studies through a literature search. Each eligible RCT was used to obtain information on MID where this was used and it also contributed data for the calculation of the baseline pooled standard deviation (SD) for each tendinopathy (shoulder, lateral elbow, patellar and Achilles). The rule of “half SD” was used for the computation of MIDs for patient-reported pain (visual analogue scale, VAS 0–10, single-item questionnaire) and function (multi-item questionnaires) and the rule of “one standard error of measurement (SEM)” was additionally used for the multi-item functional outcome measures.ResultsA total of 119 RCTs were included for the 4 tendinopathies. MID was defined and used by 58 studies (49%) and there were significant inconsistencies amongst studies where the same outcome measure was used as MID. From our data-driven methods the following suggested MIDs were obtained: a) Shoulder tendinopathy, pain VAS (combined) 1.3 points, Constant-Murley score 6.9 (half SD) and 7.0 (one SEM) points; b) lateral elbow tendinopathy, pain VAS (combined) 1.0 point, Disabilities of Arm, Shoulder and Hand questionnaire 8.9 (half SD) and 4.1 (one SEM) points; c) Patellar tendinopathy, pain VAS (combined) 1.2 points, Victorian Institute of Sport Assessment – Patella (VISA-P) 7.3 (half SD) and 6.6 points (one SEM); d) Achilles tendinopathy, pain VAS (combined) 1.1 points, VISA-Achilles (VISA-A) 8.2 (half SD) and 7.8 points (one SEM). The rules of half SD and one SEM produced very similar MIDs except for DASH due to its very high internal consistency. MIDs were also calculated for different pain settings for each tendinopathy.ConclusionsOur computed MIDs can be used in tendinopathy research to increase consistency. Clearly defined MIDs should be used with consistency in tendinopathy management studies in the future.

Development and testing of an alternative responder definition for EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI)

ObjectivesDryness, fatigue and joint/muscle pain are typically assessed in Sjögren’s trials using European Alliance of Associations for Rheumatology Sjögren’s Syndrome Patient Reported Index (ESSPRI). A Patient Acceptable Symptom State of...