Distribution-based Methods Research Articles

EAT During RT: Towards Data-Driven Goal Setting for Oral Intake Throughout RT as a Function Preservation Strategy

<h3>Purpose/Objective(s)</h3> Published functional benefits of maintaining oral intake [EAT] throughout radiation (RT) include shorter feeding tube utilization, and better normalcy of diet and swallow-related quality of life after RT. However, the ideal nature of oral intake (e.g., how long, how much) necessary to help set data-driven goals for functional preservation is unknown. Our aim was to: 1) describe patterns of diminishing oral intake weekly during definitive RT, and 2) explore the amount (duration) of oral intake throughout RT that associates with functional preservation. <h3>Materials/Methods</h3> This secondary analysis of prospective registry data used MDADI composite scores 3-6 months after RT as the primary functional outcome. Count of weeks that each patient maintained 100% oral intake (no feeding tube use) throughout radiation was the primary independent variable (weeksEAT; ranging from 0 weeks to 7 possible weeks, dichotomized to weeksEAT ≤4 weeks vs weeksEAT ≥5 weeks). Multiple linear regression models adjusted for baseline MDADI and RT weeks. The distribution-based method of minimal clinically important difference (MCID) was used to interpret ∆MDADI, defined as 0.5 SD at baseline within the cohort (MCID=6.6). <h3>Results</h3> Analysis included 545 patients treated with definitive radiotherapy for all stage oropharynx cancer (RT dose median: 69.96, IQR: 69, 69.96 Gy; 80%, 434/545 systemic therapy). Full oral intake was maintained for: 0 weeks: 4/545, <1%; 1 week: 4/545, <1%; 2 weeks: 17/545, 3%; 3 weeks: 43/545, 8%; 4 weeks: 46/545, 8%; 5 weeks: 17/545, 3%; 6 weeks: 94/545, 17%; and 7 weeks: 320/545, 59%. Composite MDADI significantly decreased from pre-RT (mean±SD: 88±13) to 3M (mean±SD: 80±15, p<0.001). WeeksEAT significantly associated with baseline and 3M MDADI (p<0.001). In adjusted models, 3M MDADI was significantly worse among 21% (114/545) of patients that maintained EAT for ≤4 weeks (baseline mean±SD: 84±17, 3M 71±16) vs 79% (431/545) who maintained EAT for ≥5 weeks (baseline mean±SD: 89±12, 3M mean±SD: 82±14, β=8, p<0.001); with an adjusted difference of 8 points (β=8, 95%CI: 5, 12: p<0.001) representing a clinically important difference. <h3>Conclusion</h3> Adherence to a full oral diet for at least 5 weeks during RT significantly associated with better post-RT swallowing-related quality of life, per MDADI. Strategies to help patients EAT through the majority of their RT despite anticipated treatment-related toxicity likely to develop mid-RT may lead to better sub-acute recovery of swallow-related quality of life. Clinically meaningful differences in MDADI scores post-treatment may motivate a data driven target for patients and providers to sustain a full oral diet as long as possible during treatment.

Identifying Minimal and Meaningful Change in a Patient-Reported Outcomes Measurement Information System for Rheumatoid Arthritis: Use of Multiple Methods and Perspectives.

Rheumatoid arthritis (RA) is chronic, painful, disabling condition resulting in significant impairments in physical, emotional, and social health. Our objective was to use different methods and perspectives to evaluate the responsiveness of Patient-Reported Outcomes Measurement Information System (PROMIS) short forms (SFs) and to identify minimal and meaningful score changes. Adults with RA who were enrolled in a multisite prospective observational cohort completed PROMIS physical function, pain interference, fatigue, and participation in social roles/activities SFs, the PROMIS 29-item form (PROMIS-29), and pain and patient global assessment, and rated change in specific symptoms and RA (a little versus lot better or worse) at the second visit. Physicians recorded joint counts, physician global assessment, and change in RA at visit 2. We compared mean score differences for minimal and meaningful improvement/worsening using patient and physician change ratings and distribution-based methods, and we visually inspected empirical cumulative distribution function curves by change categories. The 348 adults were mostly female (81%) with longstanding RA. Using patient ratings, generally 1-3-point differences were observed for minimal change and 3-7 points for meaningful change. Larger differences were observed with patient versus physician ratings and for symptom-specific versus RA change. Mean differences were similar among SF versions. Prespecified hypotheses about change in PROMIS physical function, pain interference, fatigue, and participation and legacy scales were supported. PROMIS SFs and the PROMIS-29 profiles are responsive to change and generally distinguish between minimal and meaningful improvement and worsening in key RA domains. These data add to a growing body of evidence demonstrating the robust psychometric properties of PROMIS and supporting its use in RA care, research, and decision-making.

485 Identifying the Minimum Clinically Important Differences (MCID) in ISNCSCI Score for Patients with Traumatic Spinal Cord Injury: An Analysis from the National Spinal Cord Injury Model Systems (SCIMS) Database

INTRODUCTION: Spinal Cord Injury (SCI) is a major cause of disability, mostly presenting due to a traumatic event such as a motor vehicle accident or a fall. To evaluate and follow-up the neurological recovery for patients with SCI, several scales, and scoring systems have been published with the collaborative multidisciplinary efforts, including the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). Identifying an MCID for this scoring system is crucial to evaluate patient improvement and provide hints about the success of any intervention. METHODS: National Spinal Cord Injury Model Systems Database was queried from 2001-2016 for patients admitted to rehabilitation centers following traumatic spinal cord injury. The following methods were used to identify MCIDs; (i) anchor-based methods where an outcome measure is selected to be the “anchor” (Functional Independence Measure) and defined changes in this anchor is linked to the changes in the investigated outcome measure (ISNCSCI motor scores) and (ii) distribution-based methods where several different parameters (Standard error of measurement, half standard deviation, etc.) are used determine one MCID. RESULTS: A total of 1,521 patients were identified. MCIDs for the overall cohort ranged from 3.25 to 6.6 for the anchor-based methods and 0.93 to 5.30 based on the distribution-based methods. Although slight changes were seen, the range of MCIDs was found to be similar to the overall cohort when cohorts were stratified by sex, the level of injury, complete/incomplete injury, and different age groups. The highest MCID was detected for patients with cervical injury in both anchor-based (9.03) and distribution-based approaches (6.06), while the lowest MCID was detected for patients with thoracic injury in both anchor-based (1.0) and distribution-based approaches (0.23). CONCLUSION: Our findings demonstrated similar results with regards to MCIDs for ISNCSCI scoring between different patient profiles (stratified by sex, the level of injury, complete/incomplete injury, and age groups) with scores ranging from 0.23 to 9.09 based on different approaches. Anchor-based methods provided higher MCIDs overall when compared to distribution-based methods.

Minimum clinically important difference of the Social Functioning in Dementia Scale (SF-DEM): cross-sectional study and Delphi survey

ObjectivesGood social functioning is important for people living with dementia and their families. The Social Functioning in Dementia Scale (SF-DEM) is a valid and reliable instrument measuring social functioning in...

Minimal clinically important differences in daily physical activity outcomes following supervised and home-based exercise in peripheral artery disease.

Introduction: We estimated minimal clinically important differences (MCID) for small, moderate, and large changes in daily step counts and time spent in moderate-to-vigorous physical activity (MVPA) following both supervised and home-based exercise programs in symptomatic patients with peripheral artery disease (PAD). Methods: Patients were randomized to either 12 weeks of a supervised exercise program (n = 60), a home-based exercise program (n = 60), or an attention-control group (n = 60). Results: Using the anchor-based method to determine MCID, the MCID value for a large change in health-related quality of life (HRQoL) was an increase of 1211 total daily steps and an increase in 11 minutes in the time spent in MVPA following 12 weeks of exercise intervention. Using the distribution-based method, the MCID values for small, moderate, and large changes in total daily steps in the home-based exercise group were 558, 1396, and 2233 steps/d, respectively, and the corresponding changes in the time spent in MVPA were 6, 15, and 23 minutes. Similar distribution-based MCID scores were noted for the supervised exercise group. Conclusion: Following 3 months of home-based and supervised exercise programs for patients with PAD and claudication, increases of 11 minutes in time spent in MVPA and 1211 total daily steps were associated with large anchor-based MCID increases in HRQoL. The clinical implication is that patients with PAD and claudication should be encouraged to increase daily steps, particularly by walking an additional 11 minutes each day in MVPA, which is associated with a large meaningful increase in HRQoL.

The Minimal Clinically Important Difference, Substantial Clinical Benefit, and Patient-Acceptable Symptomatic State after Medial Patellofemoral Ligament Reconstruction

PurposeTo define the minimal clinically important difference (MCID), substantial clinical benefit (SCB) and patient-acceptable symptomatic state (PASS) for patient-reported outcome measures (PROMs) after medial patellofemoral ligament reconstruction (MPFLR) and to investigate the role of preoperative, demographic, and intraoperative variables for predicting achievement of these thresholds.MethodsThis retrospective cohort study used a prospectively maintained database of patients undergoing primary MPFLR between August 2015 and December 2019. PROMs included the International Knee Documentation Committee (IKDC), Knee Injury and Osteoarthritis Outcome Score (KOOS), KOOS joint replacement (JR), and Kujala. Anchor-based and distribution-based methods were used to calculate the MCID, SCB, and PASS. Regression analyses were performed to identify prognosticators for achievement of clinically significant thresholds.Results139 patients met inclusion criteria (mean age: 21.7± 8.2 years). At 6 months, the MCID values were 8.3 (KOOS-Pain) and 8.5/13.5 (Kujala); SCB values were 1.4 (KOOS-Pain) and 43.7 (KOOS-QOL); and PASS values were 64.9 (IKDC), 83.3 (KOOS-Symptom), 76.8 (KOOS-Pain), 91.2 (KOOS-ADL), 47.5 (KOOS-Sport), 40.6 (KOOS-QOL), and 78.1 (KOOS-JR). At 1 year, the MCID values were 4.2 (KOOS-Pain), 7.2 (KOOS-ADL), 12.4 (KOOS-QOL) and 25.2 (KOOS-JR); SCB were 23.6 (IKDC), 4.2 (KOOS-Symptom), 19.7 (KOOS-Pain), 6.5 (KOOS-ADL), 55.0 (KOOS-Sport), 6.3 (KOOS-QOL), and 19.6/25.2 (KOOS-JR); and PASS were 65.5 (IKDC), 80.4 (KOOS-Symptom), 84.7 (KOOS-Pain), 99.3 (KOOS-ADL), 57.5 (KOOS-Sport), 53.1 (KOOS-QOL), and 76.3 (KOOS-JR). In regression analysis, greater age, body mass index, and preoperative PROMs were negative prognosticators for achieving clinically significant thresholds. Conversely, male gender increased the likelihood of achieving PASS for Kujala at 6 months and KOOS-ADL at 1 year.ConclusionsThis study established thresholds for the MCID, SCB, and PASS at 6 months and 1 year after MPFLR, providing physicians an evidence-based method to advise patients and assess outcomes with this surgery. Older patients and those with higher preoperative outcome scores are less likely to report improvement and satisfaction with MPFLR, while male patients are more likely to report some satisfaction.Level of EvidenceLevel III, retrospective cohort study (diagnosis).

Deconstructing the Minimum Clinically Important Difference (MCID).

PurposeThe minimal clinically important difference (MCID) is a way of dichotomizing data for assessment of success or failure based on clinically meaningful changes. The magnitude of the MCID is often misunderstood to be a singular quantity applicable across studies. However, substantial differences have been reported among MCIDs for the same outcome measures usually based upon differences extrinsic to the calculation. This study explores the effects of variabilities intrinsic to the calculation of the MCID.MethodsThe MCIDs for two knee replacement patient-reported outcomes measures of pain and function were calculated at 1 year postoperative with an integrative anchor and distribution-based method using external anchor questions and receiver operator characteristic (ROC) curves. The effects upon the magnitude and precision of the MCIDs of varying the anchor questions, the thresholds for success/failure, and the sample sizes were examined.ResultsWide variabilities were observed in both the magnitudes and precision of the MCIDs. The threshold for success had the largest effect on magnitude of pain scores, while the sample size had the largest effect on precision. For function scores, the sample size had the largest effect on magnitude, and the anchor question had the largest effect on precision.ConclusionComparisons among MCIDs are difficult to interpret if elements of the calculations are different and influence the results. While factors extrinsic to the calculations, e.g., study population, trial design, methods of calculation, etc., are known to produce differences in the magnitude of MCIDs, this study shows that more subtle and less obvious factors intrinsic to the calculations have profound effects on both the magnitude and precision of MCIDs. Comparisons among MCIDs should be made with caution and call for greater transparency in reporting intrinsic methods. It is probably advisable for individual studies to calculate their own MCIDs and not rely on published values.

Responsiveness and Minimal Important Change of the Quebec Back Pain Disability Scale in Italian patients with chronic low back pain undergoing multidisciplinary rehabilitation.

There is still a lack of information concerning Minimal Important Change (MIC) of the Quebec Back Pain Disability Scale (QBPDS), that limits its use for clinical and research purposes. Evaluating responsiveness and MIC of the QBPDS in Italians with chronic low back pain (LBP). This is a methodological research based on an observational study. Outpatient rehabilitation hospital. Two hundred and one patients with chronic LBP. At the beginning and end of a multidisciplinary rehabilitation program, patients completed the QBPDS. At the end of treatment, they completed a 7-level global perceived effect (GPE) scale, which was split to obtain a dichotomous outcome (improved vs. stable). Responsiveness was calculated by distribution-based (effect size [ES]; standardized response mean [SRM]; minimum detectable change [MDC<inf>95</inf>]) and anchor-based methods (receiver operating characteristics [ROC] curves). ROC curves were also used to compute the MIC (based on QBPDS change score, both absolute and expressed as percentage). Correlations between the change score of the QBPDS and GPE were calculated. The ES was 0.29, the SRM was 0.43, and the MDC<inf>95</inf> was 12 points. ROC analysis of the absolute change scores showed a MIC value of 6 points, with an area under the curve (AUC), sensitivity, and specificity of 0.83 (95% CI: 0.77-0.90), 77.7% and 80.8%, respectively. ROC analysis based on the percent change score from baseline revealed a MIC of 18% with an AUC, sensitivity and specificity of 0.85 (95% CI: 0.79-0.91), 80.6% and 80.8%, respectively. Correlation between change score of the QBPDS and GPE was ρ=-0.67. The QBPDS score change (expressed in both absolute value and percentage from baseline) was sensitive in detecting clinical changes in Italian subjects with chronic LBP undergoing multidisciplinary rehabilitation. In clinical practice, where absolute change is lower than MDC we recommend to rely on the MIC taking into account the percentage change from baseline condition. The present study investigated the responsiveness and MIC of the QBPDS in a group of patients with chronic LBP. Our findings showed that the QBPDS score may classify with good to excellent discriminatory accuracy subjects who consider themselves as improved. Where examining change, we recommend considering both MICs we provided (expressing score change both in absolute value and as a percentage from baseline), and disregard values lower than MDC<inf>95</inf>, not being discernible from measurement error.

Minimal Clinically Important Difference (MCID) at One Year Postoperatively in Aseptic Revision Total Hip Arthroplasty

BackgroundOutcomes after aseptic revision total hip arthroplasty (THA) are variable, and it is unknown whether the indication for aseptic revision THA influences postoperative clinical improvement. The minimal clinically important difference (MCID) assesses if changes in patient-reported outcome measure result in meaningful clinical benefit to patients. The purpose of this study was to quantify the 1-year postoperative MCID for aseptic revision THA and to assess the percentage of patients achieving the MCID for each revision diagnosis. MethodsA prospective, single-institution registry of revision total joint arthroplasties was used. Retrospective review of 413 first-time aseptic revision THAs was performed. Demographics, revision diagnosis, preoperative Hip Disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS Jr.), and 1-year postoperative HOOS Jr. were recorded. The MCID for the HOOS Jr. at one year postoperatively was calculated for each revision diagnosis using a distribution-based method. The percentage of patients exceeding the MCID with each diagnosis was determined. ResultsThere were 9 aseptic revision diagnoses, all with n ≥ 5. The 3 most common revision diagnosis were aseptic loosening (n = 114), dislocation or instability (n = 103), and polyethylene wear or osteolysis (n = 73). The MCID for all the aseptic revision THAs was 10.9. Seven of the nine revision diagnoses achieved the MCID. The highest percentage of patients achieving the MCID was for aseptic loosening (84.2%) and implant fracture (81.3%), whereas lowest was for adverse local tissue reaction (35.3%) and implant recall (20.0%). ConclusionThe one-year revision THA MCID is 10.9 for the HOOS Jr. There is variability in the percentage of patients achieving the MCID based on diagnosis. Our data can be used to counsel patients undergoing revision THA for noninfectious etiologies.

Can minimal clinically important differences in patient reported outcome measures be predicted by machine learning in patients with total knee or hip arthroplasty? A systematic review

ObjectivesTo systematically review studies using machine learning (ML) algorithms to predict whether patients undergoing total knee or total hip arthroplasty achieve an improvement as high or higher than the minimal clinically important differences (MCID) in patient reported outcome measures (PROMs) (classification problem).MethodsStudies were eligible to be included in the review if they collected PROMs both pre- and postintervention, reported the method of MCID calculation and applied ML. ML was defined as a family of models which automatically learn from data when selecting features, identifying nonlinear relations or interactions. Predictive performance must have been assessed using common metrics. Studies were searched on MEDLINE, PubMed Central, Web of Science Core Collection, Google Scholar and Cochrane Library. Study selection and risk of bias assessment (ROB) was conducted by two independent researchers.Results517 studies were eligible for title and abstract screening. After screening title and abstract, 18 studies qualified for full-text screening. Finally, six studies were included. The most commonly applied ML algorithms were random forest and gradient boosting. Overall, eleven different ML algorithms have been applied in all papers. All studies reported at least fair predictive performance, with two reporting excellent performance. Sample size varied widely across studies, with 587 to 34,110 individuals observed. PROMs also varied widely across studies, with sixteen applied to TKA and six applied to THA. There was no single PROM utilized commonly in all studies. All studies calculated MCIDs for PROMs based on anchor-based or distribution-based methods or referred to literature which did so. Five studies reported variable importance for their models. Two studies were at high risk of bias.DiscussionNo ML model was identified to perform best at the problem stated, nor can any PROM said to be best predictable. Reporting standards must be improved to reduce risk of bias and improve comparability to other studies.

Living with chronic illness scale in Parkinson's disease: Longitudinal metric properties and meaningful change

AimTo analyze the responsiveness and interpretability of the Living with Chronic Illness Scale in patients with Parkinson's disease (LW-CI-PD). MethodsLongitudinal, international study, with a convenience sample of 153 PD Spanish and Latin-American patients assessed at baseline and one year later. The LW-CI-PD and other clinical measures were applied. For responsiveness, Wilcoxon-Mann-Whitney test of differences, correlation of change between rating scales, standard error of difference, relative change, Cohen's effect size and standardized response mean of LW-CI-PD were computed. The minimally clinical important difference was calculated using anchor- (applying the Patient Global Impression of Severity) and distribution-based methods. A triangulation of interpretability indexes was performed to determine the range of the minimally clinical important difference values. ResultsThe LW-CI-PD scored 65.7 (11.7, range: 33–101) at baseline, and 68.6 (10.3, range: 33–102) one year later (p < 0.001). Change in LW-CI-PD correlated −0.26 with change in psychosocial status, 0.18 with change in motor function and −0.15 with change in social support. Responsiveness statistics were: relative change = 4.5%; effect size = 0.25; standardized response mean = 0.46. Using PGI-S as anchor, 29 patients worsened, and the value of minimally clinical important difference for worsening in LW-CI-PD total score was 4.7. Minimally clinical important difference values using distribution-based methods were between 4.5 (1 standard error of measurement) and 10.4 (10% of total score), with a mean of 6.9. ConclusionsOur study suggest the LW-CI-PD is responsive to changes over time. The use of different methods for calculating the minimally clinical important difference allows to determine a range of the real change for the LW-CI-PD.

Cosbin: cosine score-based iterative normalization of biologically diverse samples.

Data normalization is essential to ensure accurate inference and comparability of gene expression measures across samples or conditions. Ideally, gene expression data should be rescaled based on consistently expressed reference genes. However, to normalize biologically diverse samples, the most commonly used reference genes exhibit striking expression variability and size-factor or distribution-based normalization methods can be problematic when the amount of asymmetry in differential expression is significant. We report an efficient and accurate data-driven method-Cosine score-based iterative normalization (Cosbin)-to normalize biologically diverse samples. Based on the Cosine scores of cross-condition expression patterns, the Cosbin pipeline iteratively eliminates asymmetric differentially expressed genes, identifies consistently expressed genes, and calculates sample-wise normalization factors. We demonstrate the superior performance and enhanced utility of Cosbin compared with six representative peer methods using both simulation and real multi-omics expression datasets. Implemented in open-source R scripts and specifically designed to address normalization bias due to significant asymmetry in differential expression across multiple conditions, the Cosbin tool complements rather than replaces the existing methods and will allow biologists to more accurately detect true molecular signals among diverse phenotypic groups. The R scripts of Cosbin pipeline are freely available at https://github.com/MinjieSh/Cosbin. Supplementary data are available at Bioinformatics Advances online.

Minimal important differences of EORTC QLQ-C30 for metastatic breast cancer patients: Results from a randomized clinical trial

PurposeTo establish minimal important differences (MIDs) for the European Organisation for Research and Treatment for Cancer Quality of life Questionnaire core 30 (EORTC QLQ-C30) in patients with metastatic breast cancer.MethodsThe dataset was obtained from the SELECT BC-CONFIRM randomized clinical trial. Anchors obtained from patients (transition items) and clinicians (performance status) were used for anchor-based methods. Anchors obtained through 6 months after starting treatment were used for this analysis. Correlation coefficients of anchor and change in QLQ-C30 and effect size were used to qualify for estimating MIDs. Mean change method and generalized estimating equation were applied to estimate MIDs. Distribution-based methods were used for comparison.ResultsWe analyzed a dataset of 154 metastatic breast cancer patients. MIDs were estimated in 8 of 15 scales of QLQ-C30. Estimated MIDs for within-group improvement varied from 7 to 15 and those for deterioration varied from − 7 to − 17. Estimated MIDs for between-group improvement varied from 5 to 11 and those for deterioration varied from − 5 to − 8 across QLQ-C30 scales. Patient-reported anchors were more susceptible to early changes in health status than clinician-reported anchors.ConclusionWe provided the MIDs of the QLQ-C30 using both patient- and clinicians-reported anchors measured in a randomized trial of Japanese patients with metastatic breast cancer. We recommend patient-reported anchors for anchor-based estimation of MID. Our results can aid patients and clinicians, as well as researchers, in the interpretation of QLQ-C30.

Gradation of Clinical Holistic Response as New Composite Outcome to Evaluate Success in Spinal Cord Stimulation Studies for Pain

IntroductionThe most prominent outcome measurement in the field of neuromodulation is pain relief. Nevertheless, the number of studies that rely on composite outcomes has increased. The aims of this study are twofold: (1) to evaluate which measures are important to include in a composite outcome and (2) to develop this new composite outcome to evaluate the degree of being a clinical holistic responder with a corresponding minimal clinical important difference (MCID). Materials and MethodsData from patients with persistent spinal pain syndrome type 2 treated with High-Dose Spinal Cord Stimulation (HD-SCS) were used. Pain intensity for low back and leg pain, disability, health-related quality of life, medication use, and patient satisfaction were measured at baseline and after 12 months of HD-SCS. Exploratory and Confirmatory Factor Analyses were used to evaluate which measures should be included in the composite outcome. Anchor-based and distribution-based methods were applied to determine the MCID of the newly developed outcome measurement. ResultsA three-factor model was the most appropriate for this data set, in which leg pain intensity, EQ5D VAS, and disability had the largest loading on these factors. A clinical holistic outcome was created with a total score ranging from 0 (=better [no pain, no disability, and perfect health status]) to 300 (=worse [maximal pain, maximal disability, and worst health status]). The MCID value based on an absolute change score from baseline up to 12 months of HD-SCS was 87.97. When calculating with percentage changes, a MCID value of 48.4% was revealed. ConclusionsThis new composite outcome evaluating the degree of deviation from being a holistic responder is a step toward a meaningful, overall outcome assessment for patients who are treated with SCS. Further studies to evaluate the psychometric properties and the generalizability toward other patient populations still need to be performed.

Assessment of Persistence Symptoms in Recovered COVID-19 Patients by Yorkshire Rehabilitation Scale (C19‐YRS): A Cross-Sectional Study from Qassim Region, Saudi Arabia

Background: Earlier back at the beginning of COVID-19, the acute phase of infection was variable from one patient to another causing different symptoms. However, many patients are still suffering from Post COVID-19 Syndrome. Hence, this study aimed to assess the persistence of symptoms in patients who recovered from COVID-19 in the Qassim Region, Saudi Arabia. Methodology: A descriptive cross-sectional study of 413 confirmed PCR test-positive covid-19 patients enrolled in this study from the Ministry of Health Electronic Surveillance System (HESN). The Yorkshire Rehabilitation Scale (C19-YRS) checklist was used to record patients’ symptoms, functioning, and disability. Data were analyzed by the SPSS program. Functional and patient-reported outcome measures were correlated with certain items from C19-YRS, the severity of symptoms. Its distribution-based methods were used for responsiveness over time. The scaling and targeting assumptions were satisfied, and internal consistency was high (Cronbach’s α = 0.843). Results: After 4 weeks of infection, 50% of patients reported persistent symptoms such as laryngeal complications, 43.8% Swallowing changes, 31.3% fatigue, 18.8% pain, 18.8% loss of appetite, 12.5% breathlessness, and 6.3% depression, Moreover, 18.8% of patients experienced reduced mobility. At the beginning of the COVID-19 infection, fever was the most common complaint 332 (80.4%), followed by 267 (64.6%) fatigue, and loss of smell 230 (55.7%). The severity of the breathlessness symptoms was exaggerated during the patients’ walking or climbing stairs. Patients who were admitted to an intensive care unit (n = 5) were significantly elderly (P < 0.001), with chronic diseases (P < 0.01) mainly Diabetes Mellitus and Hypertension. Conclusion: The study examined the severity of post covid syndrome by patients’ responsiveness to the scale items in C19-YRS. The majority of COVID-19 symptoms were still present but significantly reduced after 4 weeks of infection. Follow-up and long-term management of physical and psychological symptoms of hospitalized and non-hospitalized patients are very important.

Determining the Minimal Clinically Important Difference on the Oxford Shoulder Instability Score in Patients Undergoing Arthroscopic Bankart Repair for Shoulder Instability.

Background:The literature on minimal clinically important differences (MCIDs) for patient-reported outcome measures assessing shoulder instability is limited, with none addressing the Oxford Shoulder Instability Score (OSIS). The OSIS was developed to provide a standardized method for assessing shoulder function after surgery for shoulder instability, and previous studies have demonstrated its high reliability, low interrater variability, and ease of administration.Purpose:To identify the MCID for the OSIS after arthroscopic Bankart repair for recurrent shoulder instability.Study Design:Case series; Level of evidence, 4.Methods:A longitudinally maintained institutional registry was queried for patients who underwent arthroscopic Bankart repair from 2010 to 2016 for recurrent shoulder instability secondary to a Bankart lesion without significant glenoid bone loss. The OSIS was completed preoperatively and at 1 year postoperatively. Patients were categorized into “expectations met” and “expectations unmet” groups using a questionnaire evaluating expectation fulfilment. The MCID of the OSIS at 1 year was calculated using 3 anchor-based approaches and a distribution-based approach. The 3 anchor-based approaches comprised (1) simple linear regression analysis, (2) receiver operating characteristic curve analysis, and (3) calculation of mean differences in change for the OSIS between the “expectations met” and “expectations unmet” groups.Results:The study cohort comprised 68 men and 11 women aged 29.9 ± 12.7 years (mean ± SD). Duration of follow-up for all patients exceeded 1 year. The MCIDs for the OSIS based on the 4 calculation approaches yielded a narrow range of values, ranging from 7.7 to 8.5 for the anchor-based methods and 8.6 for the distribution-based method.Conclusion:Study results indicated that patients with recurrent shoulder instability without significant bone loss who undergo primary arthroscopic Bankart repair and have at least 8.6 points of improvement on their OSIS experience a clinically significant change at 1 year postoperatively.

POSC381 Derivation of Interpretation Thresholds for the SF-36V2® Health Survey (SF-36V2) in Rheumatoid Arthritis

Interpretation thresholds for patient-reported outcome scores are of crucial importance, particularly when interpreting treatment benefit. This post-hoc analysis aimed to determine the within-patient meaningful improvement (WPMI) threshold among patients with rheumatoid arthritis (RA) for SF-36v2, a PRO instrument comprising eight domains and two summary scores. Anchor-based and supportive distribution-based methods were used to derive WPMI based on data from two Phase 2 RA trials, with Patient’s Global Assessment of Arthritis as the primary anchor. Mean change from baseline to week 24 was calculated for the anchor category associated with meaningful improvement. WPMI was estimated based on norm-based scoring (NBS) for all SF-36v2 domain and summary scores and 0–100 scores for the eight domains. Receiver operating characteristics (ROC) curve analyses were used to evaluate the sensitivity and specificity of identified thresholds For the Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health domains, anchor-based estimates of WPMI based on NBS were 10.3, 9.6, 10.7, 6.5, 10.7, 9.0, 7.9, and 8.1, respectively, with smaller estimates based on distribution-based estimates. For the same domains, 0–100 scores were 24.5, 24.5, 25.4, 13.6, 21.5, 20.5, 16.9 and 14.3, respectively, again with smaller distribution-based estimates. Anchor-based WPMI estimates were 9.7 for Physical Component Summary Score and 7.6 for Mental Component Summary Score, with distribution-based estimates of 7.0 and 5.8, respectively. Mean change values were aligned (difference ≤2) with those provided by the cut point associated with the best sensitivity / specificity balance from ROC curve analyses in four of the eight NBS scales, but only in two of the 0–100 scores. Identified WPMI thresholds were aligned with those previously recommended. Derivation of WPMI for SF-36v2 will assist with evaluation and interpretation of treatment benefit in future RA studies.

Sensitivity to change and minimal clinically important difference of Edinburgh postnatal depression scale.

Edinburgh Postnatal Depression Scale (EPDS) was widely used in measuring depression symptoms among pregnant women. However, it is still unclear about the sensitivity to change and minimal clinically important difference (MCID) for EPDS. Based on data from an eight-week smartphone-based mindfulness intervention, scores of EPDS, 9-item Patient Health Questionnaire (PHQ-9), and 7-item Generalized Anxiety Disorder (GAD-7) before and after the intervention were collected. Three self-appraisal questions were collected after the intervention. The sensitivity to change of EPDS was determined by correlations between changes in PHQ-9, GAD-7, and EPDS. MCID for EPDS was determined by distribution-based method (0.5 standard deviation and standard error of the measurement) and anchor-based method (PHQ-9, GAD-7, and participants' self-appraisal served as anchors). The final MCID value for EPDS was calculated by average scores of the two methods. 117 women with pre-post assessments were included in the analysis. EPDS score changes from baseline to post-intervention were correlated with pre-post change in PHQ-9 and GAD-7 (r=0.540, P<0.001). The average MCID for EPDS score was found to be 4 points (ranging from -1.45 to -6.5 points) for improvement and 3 points for worsening (ranging from 1.45 to 3.5 points). The EPDS is sensitive to detect the changes in maternal depressive symptoms during pregnancy through a mindfulness course of interventions. Four points for improvement and three points for worsening are recommended as MCID for EPDS.

A New Asymptotic Distribution-Based Method for Testing the Signal-to-Noise Ratio in Birth Weight Data from Thailand

A New Asymptotic Distribution-Based Method for Testing the Signal-to-Noise Ratio in Birth Weight Data from Thailand

Interpreting the Hip Osteoarthritis Outcome Score Joint Replacement: Minimum clinically important difference values vary over time within the same patient population

Introduction Total hip arthroplasty (THA) results in outstanding outcomes and long-term implant survivorship, but there continues to be a need for tools to identify surgical candidates and assist with shared decision-making. This study aims to determine the Hip Osteoarthritis Outcome Score Joint Replacement (HOOS JR) Minimum Clinical Important Difference (MCID) at two time intervals and to evaluate different methods for calculating the HOOS JR MCID for patients undergoing THA. Methods A patient reported outcome measure (PROM) database was prospectively queried at a single outpatient ambulatory surgery center for patients treated with THA between 2017 and 2018. All patients completed PROM surveys at preoperative baseline, 3-month, and 1-year follow-up. MCID was calculated at two different intervals, baseline to 3-months and baseline to 1-year, using anchoring and distribution-based methods. Anchor-based calculations were anchored to the Patient-Reported Outcomes Measure Information System (PROMIS10) quality-of-life and physical health instruments. Results 514 patients were statistically analyzed. Average HOOS JR scores were 52.5, 79.3, and 86.1 at preoperative baseline, 3-month follow-up and 1-year follow-up, respectively. The HOOS JR MCID determined by the PROMIS10 physical health anchoring method was 30.1 and 35.5 for the 3-month and 1-year time intervals. The HOOS JR MCID determined by the PROMIS10 quality-of-life anchoring method was 31.1 and 34.8 for the 3-month and 1-year time intervals. The distribution method MCID was 8.2 for the 3-month interval and 8.4 for the 1-year interval. Conclusions MCID values vary by time and by calculation method. THA patients may require individualized and time-point specific MCID formulas to better guide clinical decision-making.