To determine how screening positive for depression preoperatively can affect patient reported outcomes after anterior cruciate ligament reconstruction (ACLR).

Primary ACLR patients between May 2020-September 2022 with a PHQ-2 score prior to their surgery were retrospectively reviewed. Patients older than 13 years of age and with minimum 6-months of follow-up were included for analysis. Patients were categorized as PHQ(+) (PHQ-2 ≥2) or PHQ2(-) (PHQ-2 < 2). Demographics, preoperative and postoperative Patient Reported Outcome Information System (PROMIS) -Physical Function (PF) and Pain Interference (PI) scores, Patient Acceptable Symptomatic State (PASS), surgical clinical outcomes, and complications were collected and compared. Chi-square tests and independent t-tests were used for categorical and continuous variables, respectively.

A total of 127 patients were analyzed, with 32 PHQ2(+) and 95 PHQ2(-). The PHQ2(+) group had a lower proportion responding "yes" to PASS preoperatively (6.5 % vs. 25.3 %, p = 0.03), at 9 months (47.4 % vs. 72.4 %, p = 0.05), and 12 months postoperatively (42.9 % vs 79.5 %, p = 0.009). PHQ2(+) reported worse PROMIS-PI scores preoperatively, at 6 months, and at 9 months. The PHQ2(+) group reported worse PROMIS-PF preoperatively, at 6 months, at and 12 months. The PHQ2(+) group had worse IKDC scores preoperatively at 9 months and at 12 months. Those screening positive for depression also demonstrated a higher incidence of postoperative complications (34.4 % vs. 9.5 %, p = 0.001) and reoperation rates (21.9 % vs. 4.2 %; p = 0.002).

A brief preoperative survey, such as the PHQ-2, can provide prognostic value for patient outcomes after ACLR.

III-Retrospective cohort study.

ObjectiveThe aim of this study was to establish the minimal clinically important difference (MCID) thresholds for the International Knee Documentation Committee (IKDC) subjective and Visual Analogue Scale (VAS) pain scores in patients affected by knee chondral and osteochondral lesions treated with cell-free scaffold implantation.DesignFor the MCID definition, 186 patients who underwent an osteochondral scaffold implantation were included. Patients were evaluated through the IKDC subjective and VAS pain scores at baseline, 12 and 24 months. The MCID was calculated using a distribution-based method for both IKDC subjective and VAS pain scores at 12 and 24 months, as well as with an anchor-based method.ResultsThe MCID values were 10.1 and 1.5 for the IKDC subjective and VAS pain scores, respectively, both at 12 and 24 months of follow-up. The rate of patients who achieved the MCID was 83% at 12 months and 88% at 24 months. The anchor-based method led to higher MCID values. Factors identified to increase the probability to reach the MCID were younger age (P = 0.042), male sex (P = 0.042), and lateral femoral condyle lesions (P = 0.002), while patellar lesions were less likely to reach the MCID (P = 0.009).ConclusionsThis study defined the MCID values for the IKDC subjective and VAS pain scores after treatment with a cell-free biomimetic scaffold, with 88% of the patients achieving clinically relevant results at 2 years. Younger patients, males and lateral femoral condyle lesions were more likely to reach the MCID. However, the identified thresholds can be influenced by the method chosen, which warrants caution when interpreting study results.

Mastectomy, a surgical procedure involving the removal of breast tissue, is a common treatment option for breast cancer. Post treatment, survivors often experience both physical and psychological symptoms, which in turn delay the recovery phase. Post-mastectomy wound complications, such as infection, pain, delayed healing, seroma formation, persistent discomfort and limited mobility often lead to prolonged hospital stays and reduced quality of life. Proper wound care, including dressing changes and wound management, is crucial for optimal healing. However, mastectomy also has a significant emotional and psychological impact on patients, leading to depression, anxiety, and poor body image due to significant changes in the body such as loss of hair, unsightly scars and weight changes. Patients also feel uncomfortable when medical professionals concentrate solely on survival, rather than empathizing with them. While these emotional reactions are often expected and considered normal during breast cancer treatment, what comes as a surprise is the additional harm caused by healthcare providers' communication and behaviour when treating breast cancer patients. Despite advances in medical technology, there remains a significant gap in providing psychosocial support for breast cancer survivors. Undergoing a mastectomy is an emotionally challenging experience, and healthcare providers play a vital role in establishing the groundwork for psychological recuperation. By incorporating empathetic practices into daily patient care, healthcare providers can be trained to create an unbiased, informative, and compassionate environment, to improve patient outcomes and satisfaction. The use of compassionate communication when interacting with the patient and their care givers can foster a more nurturing atmosphere for all parties involved. By prioritizing empathy in post-mastectomy wound care, healthcare providers can enhance the overall well-being of breast cancer survivors. This review explores the physical and emotional impact of mastectomy on patients, the healing process, and the importance of integrating empathy into post-mastectomy wound care.

The Minimum Important Change of the Patient Evaluation Measure for patients recovering from a finger fracture or joint injury was estimated to aid the design of future trials. Data from the Patient Outcomes for Finger Fractures and Joint Injuries prospective cohort study were used. Sixty participants were included. Patients were given the Patient Evaluation Measure questionnaire at baseline and at 6, 12 and 24 weeks with corresponding anchor questions. The Minimum Important Change values for the Patient Evaluation Measure at 24 weeks was between 12 and 17 depending on the statistical estimation method used. Although some variation existed across differing time-points, the range was broadly consistent. The Minimal Detectable Change was estimated as between 9 and 11.Level of evidence: II.

Duchenne Muscular Dystrophy is a progressive neuromuscular disorder characterized by the gradual weakening and deterioration of muscles, leading to loss of ambulation in affected individuals. This decline in mobility can be effectively assessed using the North Star Ambulatory Assessment (NSAA) scores, along with measures such as the 10-m walk time and the time taken to rise from the floor. We propose a dynamic linear model to predict the trajectories of these clinical outcomes, with a primary focus on NSAA scores. Our model aims to assist clinicians in forecasting the progression of the disease, thereby enabling more informed and personalized treatment plans for their patients. We also evaluate the effectiveness of our models in generating synthetic NSAA score datasets. We assess the performance of our modelling approach and compare the results with those of a previous study. We show that the most robust model demonstrates narrower prediction intervals and improved quantile coverage, indicating superior predictive accuracy and reliability.This article is part of the theme issue 'Uncertainty quantification for healthcare and biological systems (Part 2)'.

Cancer is currently the second most common cause of death worldwide and is often treated with chemotherapy. Music therapy is a widely used adjunct therapy offered in oncology settings to attenuate negative impacts of treatment on patient's physical and mental health; however, music therapy research during chemotherapy is relatively scarce. The aim of this study is to evaluate the impact of group music therapy sessions with patients and caregivers on their perceived anxiety, stress, and wellbeing levels and the perception of chemotherapy-induced side effects for patients.

This is a retrospective cohort study following the STROBE guidelines. From April to October 2022, 41 group music therapy sessions including 141 patients and 51 caregivers were conducted. Participants filled out pre- and post-intervention Visual Analogue Scales (VAS) assessing their anxiety, stress, and wellbeing levels, and for patients the intensity of chemotherapy-induced side effects.

The results show a statistically significant decrease of anxiety and stress levels (p < .001), an increase in well-being of patients and caregivers (p < .001, p = .009), and a decrease in patients' perceived intensity of chemotherapy-induced side effects (p = .003). Calculated effect sizes were moderate for anxiety, stress, and well-being levels, and small for chemotherapy-induced side effects.

This is the first study regarding group music therapy sessions for cancer patients and their caregivers during chemotherapy in Colombia. Music therapy has been found to be a valuable strategy to reduce psychological distress in this population and to provide opportunities for fostering self-care and social interaction.

Music therapy should be considered as a valuable complementary therapy during chemotherapy. However, it is crucial to conduct prospective studies with parallel group designs to confirm these preliminary findings.

BackgroundThe Wolf Motor Function Test (WMFT) and its modified versions are widely used to assess upper limb (UL) function in stroke survivors. However, comprehensive evaluations of its psychometric properties are lacking.ObjectiveTo perform a systematic review with meta-analysis on the psychometric properties (following the COnsensus-based Standards for the selection of health Measurement INstruments [COSMIN] taxonomy) of the WMFT and modified versions in stroke survivors.MethodsSix databases were searched until May 2024 for studies examining at least one WMFT measurement property in stroke patients. Two independent reviewers conducted study selection, data extraction, and quality assessment using the COSMIN Risk of Bias checklist and quality of evidence (QoE) with the Grading of Recommendations Assessment, Development, and Evaluation approach. Meta-analyses synthesized psychometric properties reported in at least two studies.ResultsTwenty-five studies (N = 2044) were included. Regarding the WMFT Functional Ability Scale (FAS) and TIME scales, internal consistency (alpha ≥ .88), intra-rater (intraclass correlation coefficient [ICC] ≥ .97) and inter-rater (ICC ≥ .92) reliability, measurement error for TIME, construct validity (strong correlations [r ≥| .64|] with Fugl-Meyer Assessment and Action Research Arm Test), and responsiveness (ES ≥ 0.48) were rated sufficiently with QoE from very low to high. Measurement error for FAS was assessed as inconsistent with moderate QoE, and cross-cultural validity was rated as indeterminate with very low QoE. Content validity was not assessed. Few studies investigated the psychometric properties of the modified versions.ConclusionsWMFT demonstrates robust psychometric properties in assessing UL function in stroke survivors. While the WMFT-modified versions showed promising properties, further research is needed to use them. Future studies should focus on WMFT measurement error, content, and cross-cultural validity.Trial Review Registration:PROSPERO: CRD42021237425.

Late radiation-associated dysphagia (RAD) after head and neck cancer (HNC) treatment is challenging and commonly treatment refractory, with fibrosis stiffening connective tissues and compressing peripheral nerve tracts, contributing to diminished strength and possibly denervation of swallowing muscles. Manual therapy (MT), while common for cancer-related pain and other indications, remains largely unstudied for fibrosis-related late RAD.

To determine the feasibility and safety of MT, estimate effect size and durability of MT for associated improvements in cervical range of motion (CROM), and examine functional outcomes after MT in survivors of HNC with fibrosis-related late RAD.

This nonrandomized clinical trial, Manual Therapy for Fibrosis-Related Late Effect (MANTLE) Dysphagia in Head and Neck Cancer Survivors, is a prospective, single-institution, pilot, single-arm supportive care trial conducted at a National Comprehensive Cancer Network-designated academic comprehensive cancer center. Participants were adult survivors of HNC who were disease free at 2 or more years after curative-intent radiotherapy with grade 2 or higher fibrosis (per Common Terminology Criteria for Adverse Events version 4.0) and grade 2 or higher dysphagia (per video fluoroscopy Dynamic Imaging Grade of Swallowing Toxicity [DIGEST]). Data were collected June 2018 to July 2021 and analyzed November 2022 to November 2024.

MANTLE included 10 hourly MT sessions by lymphedema-certified speech-language pathologists over 6 weeks with a home exercise program. During the subsequent 6-week washout period, participants implemented only the home exercise program, without clinician MT.

Primary end points were feasibility (per therapy completion rate, with a 75% target) and safety. Secondary end points included functional outcomes per CROM, dysphagia severity (per DIGEST), maximum interincisal opening (MIO), and validated participant-reported outcomes (PROs).

Among 24 survivors of HNC (20 male [83.3%]; median [range] age, 68 [53-80] years), there was a median (range) of 8.9 (2.4-30.2) years after curative-intent radiotherapy. A total of 22 participants (91.7%) completed the 10 prescribed therapy sessions, and 1 participant experienced a severe adverse event. Secondary end points improved among participants who completed the therapy: MIO (r = 0.76; 95% CI, 0.66 to 0.94) and all 6 planes of CROM (eg, cervical extension: r = 0.86; 95% CI, 0.83 to 0.93) improved, with large effect sizes from baseline to after MT. Large to moderate effect sizes were achieved in symptom measures per PROs (eg, lymphedema-fibrosis symptom severity after MT: r = 0.74; 95% CI, 0.63 to 0.99). However, effect sizes were small to moderate or null in uncompensated swallowing outcome measures (eg, MD Anderson Dysphagia Inventory composite score from baseline to after MT: r = 0.38; 95% CI, 0.07 to 0.73).

This study found that MT was safe and feasible in long-term survivors of HNC with late RAD and was associated with several functional, physical, and psychosocial gains. This trial may offer insight into next directions to optimize swallowing outcomes by integrating MT into a comprehensive rehabilitation program.

ClinicalTrials.gov Identifier: NCT03612531.

The minimal and robust clinically important difference (MCID and/or RCID) are essential in assessing the clinical significance of multidimensional fatigue inventory-20 and checklist of individual strength-fatigue subscale questionnaires changes scores. This is the first study to determine the MCID and RCID of these questionnaires in chronic stroke survivors.

A total of 125 participants in an observational cohort study completed MFI-20 and CIS-fs before and after receiving multidisciplinary rehabilitation (cognitive behavioral therapy, graded exercise and adaptive pacing therapy). Anchor-based MCIDs and RCIDs were calculated using the mean change, the mean difference and the receiver operating characteristics methods. To evaluate the accordance between of distribution-based MCIDs (1 SD, ½ SD, SEM, 1.96 SEM and MDC values) with anchored values, the accuracy, sensitivity, specificity and Youden's index were calculated.

The anchored MCIDs were between -5 to -7.33 for MFI-20 and -4.87 to -5.40 for CIS-fs. The anchored RCIDs ranged from -5 to -13.88 and -6 to -9.88 for MFI-20 and CIS-fs, respectively. The values of ½ SD and SEM for CIS-fs were consistent with anchored RCIDs.

The estimated MCIDs and RCIDs of MFI-20 and CIS-fs can help researchers and clinicians interpret their chronic stroke patient data.

There has been no recent updated comprehensive review of measurement properties focused on the 5-repetition sit-to-stand test (5R-STS) in patients with lumbar degenerative disorders (LDD) that could aid in better understanding of its clinical and research applicability.

The aim of this systematic review was to summarize evidence on measurement properties of the 5R-STS in patients with LDD according to COnsensus Based Standards for the Selection of Health Measurement INstruments (COSMIN) guidelines.

Systematic review and meta-analysis.

In Step 1 and 2, 3,363 and 1,287 adult patients with suspected or diagnosed either clinically and/or radiologically LDD were included, respectively. Step 2 involved screening studies from Step 1 that passed the full text-stage and including only those that assessed at least 1 COSMIN measurement property.

Functional Measures (5R-STS, Timed Up and Go Test). Self-report Measures (including Oswestry Disability Index (ODI), Roland Morris Disability Questionnaire, pain scores eg, Visual Analogue Scale) and healthcare quality of life questionnaires (eg, EQ-5D-3L)).

In December 2022 Embase, PubMed/Medline, Web of Science and Scopus were searched for studies of 5R-STS of patients with LDD (PROSPERO: CRD42022383095). Quality of evidence was assessed using GRADE and COSMIN Checklist. Results for measurement error were pooled using the weighted mean method. Random effect meta-analysis was performed for studies on reliability and criterion validity.

Thirty-eight full-text articles were included in Step 1 and 19 in Step 2. The overall intraclass correlation coefficient (ICC) of test-retest reliability and inter-rater reliability of the 5R-STS was 0.93 (95% CI 0.37-1.00) and 0.99 (95% CI 0.83-1.00), respectively. The weighted standard error of measurement (SEM) mean value was 2.8s. Estimated r of 5R-STS and ODI, reflecting insufficient criterion validity (since r <0.70), was 0.53 (95% CI 0.17-0.88). Hypothesis testing for construct validity was confirmed for 40% of predefined hypothesis (graded as insufficient since overall, not >70% hypothesis confirmed). Accounting for limited evidence, responsiveness of the test was adequate.

This COSMIN systematic review summarizes 5R-STS measurement properties in patients with LDD, including pooled estimates of ICC for reliability, SEM, and correlation between 5R-STS and ODI. The 5R-STS is a reliable and responsive instrument reflecting a new dimension of functional impairment in patients with LDD.

Few certainties exist regarding the optimal type, timing, or dosage of rehabilitation after stroke. Despite differing injury mechanisms and recovery patterns following ischemic and hemorrhagic stroke, most translational stroke research is conducted after ischemia. As we enter the era of personalized medicine, exploring subtype-specific treatment efficacy is essential to optimizing recovery. Our objective was to characterize common rehabilitation interventions used after in vivo preclinical intracerebral hemorrhage (ICH) and assess the impact of post-ICH rehabilitation (vs. no-rehabilitation) on recovery of motor function. Following PRISMA guidelines, a systematic review (Academic Search Complete, CINAHL, EMBASE, Medline, PubMed Central) identified eligible articles published up to December 2022. Risk of bias (SYRCLE) and study quality (CAMARADES) were evaluated, and random-effects meta-analysis was used to assess treatment efficacy in recovery of forelimb and locomotor functions. Thirty articles met inclusion criteria, and 48 rehabilitation intervention groups were identified. Most used collagenase to model striatal ICH in young, male rodents. Aerobic exercise, enriched rehabilitation, and constraint-induced movement therapy represented ~ 70% of interventions. Study quality was low (median 4/10, range 2-8), and risk of bias was unclear. Rehabilitation provided modest benefits in skilled reaching, spontaneous impaired forelimb use, and locomotor function; however, effects varied substantially by endpoint, treatment type, and study quality. Rehabilitation statistically improves motor function after preclinical ICH, but whether these effects are functionally meaningful is unclear. Incomplete reporting and variable research quality hinder our capacity to analyze and interpret how treatment factors influence rehabilitation efficacy and recovery after ICH.

Disturbed body image is a potential precursor and maintaining factor when it comes to eating disorders. One of the dominant treatment approaches for eating disorders, enhanced cognitive-behaviour therapy (CBT-E), includes the cognitive-affective body image dimension as a core treatment target. Adding a component that focuses on the lived body dimension, could improve body image. In the current study, the feasibility of a psychomotor body image treatment as an add-on to CBT-E was examined.

In this pilot study, 115 primarily female patients with different eating disorders in outpatient CBT-E treatment participated. They were asked to complete questionnaires examining body image before and after the psychomotor body image treatment.

Results showed good satisfaction with the treatment, and a significant improvement in body attitude and body satisfaction after the psychomotor body image treatment, with large effect sizes and clinical relevance. Results also showed that, overall, pre-treatment levels and changes over the course of treatment in body attitude and body satisfaction did not differ between patients within anorexia nervosa, bulimia nervosa or binge eating disorder diagnostic subgroups.

Limitations were lack of a control group, and the fact that the body image treatment was complementary to CBT-E. This means that it is unclear whether other factors contributed to the change in body image as shown in the current study.

These results indicate that an experiential psychomotor approach in addition to a more cognitive-behavioral approach is feasible, and warrants future research.

BackgroundThe Shoulder Pain and Disability Index (SPADI) is one of the most widely used Patient Reported Outcome Measures designed to assess the severity of pain and disability in patients with shoulder conditions.ObjectiveThe aim of the study is to define the clinically significant outcomes of the Minimum Clinically Important Difference (MCID), Substantial Clinical Benefit (SCB) and Patient Acceptable Symptom State (PASS) for the SPADI scores after Rotator Cuff Repair (RCR).MethodsThe present study takes into account patients undergone RCR with a 6-month follow-up. The MCID, PASS and SCB of the SPADI score were evaluated using both distribution and anchor approaches.ResultsFifty-nine patients (mean aged 60.3 ± 13.1 years) who had undergone RCR in a single surgical center were retrospectively included. The MCID cutoff of the SPADI total score after RCR from the initial evaluation to 6 months post-operatively was 17 (95% CI:13.6,20.4). The outcome measures for the MCID and SCB values of the SPADI pain score were 26 (95% CI:22.3,29.7) and 37 (95% CI:33.4,40.6), respectively. The MCID threshold of the SPADI disability score was 21.9 (95% CI:18.7,25.1). A value of at least 76.9 (95% CI:73.4,80.4), 75 (95% CI:71.6,78.4), and 78.1 (95% CI:74.6,81.6) for SPADI total, pain, and disability dimensions, represented the PASS.ConclusionsThe study shows significant improvements in SPADI scores after RCR, suggesting that could lead to meaningful pain relief and functional recovery. The findings indicate that a post-operative SPADI total score of at least 76.9 correlates with patient satisfaction regarding shoulder health.

The aim of this study was to apply the minimum clinically important difference (MCID) concept to clinical results for Japanese patients with major depressive disorder following inadequate response to antidepressants, and to explore the disparity in what physicians and patients considered important in the treatment of depression.

The original study was a 52-week, open-label, multicenter study on the administration of 2 mg/d of brexpiprazole as adjunctive therapy for patients with major depressive disorder. Here, we conducted a post hoc analysis to determine the MCID in Montgomery-Åsberg Depression Rating Scale (MADRS), Sheehan Disability Scale (SDS), and EQ-5D-5L-derived utility score. We compared the area under the curve (AUC) and correlation coefficients for the MADRS, SDS, and utility scores between the physicians' and patients' responses.

The MCIDs for this patient group were 4.89-4.94 for the MADRS score, 31.15-35.10% for the MADRS improvement rate, 0.69-2.14 for the SDS score, and 0.045-0.195 for the utility score. The MCIDs for the SDS and utility scores derived from the patient-perspective anchor were almost twice as high as those from the physician-perspective anchor. The utility score had the highest AUC and correlation coefficient for the patient-perspective anchor, while the MADRS score did for the physician-perspective anchor.

The MCIDs for the MADRS, SDS, and EQ-5D-5L -derived utility scores were estimated. Physicians focus more on depressive symptoms and prioritize symptom severity over improvements in functionality and activities of daily life, in contrast to patients, who prioritize such improvements.

As the United States health-care system transitions to a value-based model, the minimal clinically important difference (MCID) has become an important metric for assessing perceived benefit in clinical settings. However, there is substantial ambiguity surrounding the MCID value because the calculation method used can lead to substantial changes in the clinical interpretation of surgical success.

A total of 1,113 patients who underwent either total knee arthroplasty (TKA) or total hip arthroplasty (THA) between June 2021 and June 2023 and completed their patient-reported outcomes (the KOOS JR [Knee injury and Osteoarthritis Outcome Score for Joint Replacement] or HOOS JR [Hip disability and Osteoarthritis Outcome Score for Joint Replacement]) preoperatively and at 1 year postoperatively were reviewed for this study. The MCID values for the HOOS JR and KOOS JR were determined using 16 statistically appropriate methods, and the resulting MCID values were applied to the study group to assess how differences in methods changed the number of patients who met the MCID at 1 year postoperatively.

The study cohort consisted of 570 patients who underwent TKA and 543 who underwent THA. The overall cohort was 62.2% female, had a mean age of 69.3 ± 8.3 years, and was 92.3% Caucasian, 2.9% African American, and 4.8% other race (i.e., Asian, multiracial, or "other"). The MCID values varied substantially among the methods evaluated. The mean MCID was 11.5 ± 9.2 (range, 0.5 to 36.6) for the KOOS JR and 12.2 ± 8.9 (range, 0.6 to 34.3) for the HOOS JR. Distribution-based methods led to smaller but more variable MCID values, whereas anchor-based methods were noted to have larger but more consistent MCID values.

Different statistical approaches resulted in substantial variation in the MCID threshold value, which affected the number of patients who reached the MCID. This study demonstrates the ambiguity of the MCID and casts some doubt regarding its utility for assessing the surgical benefit of total joint arthroplasty.

Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

The minimal clinically important difference (MCID) represents a pivotal metric in bridging the gap between statistical significance and clinical relevance, addressing the direct impact of medical interventions from the patient's perspective. This comprehensive review analyzes the evolution, applications, and challenges of MCID across medical specialties, emphasizing its necessity in ensuring that clinical outcomes not only demonstrate statistical significance but also offer genuine clinical utility that aligns with patient expectations and needs. We discuss the evolution of MCID since its inception in the 1980s, its current applications across various medical specialties, and the methodologies used in its calculation, highlighting both anchor-based and distribution-based approaches. Furthermore, the paper delves into the challenges associated with the application of MCID, such as methodological variability and the interpretation difficulties that arise in clinical settings. Recommendations for the future include standardizing MCID calculation methods, enhancing patient involvement in setting MCID thresholds, and extending research to incorporate diverse global perspectives. These steps are critical to refining the role of MCID in patient-centered healthcare, addressing existing gaps in methodology and interpretation, and ensuring that medical interventions lead to significant, patient-perceived improvements.

The routine measurement of children's developmental health varies across educational settings and systems. The Early Years Foundation Stage Profile (EYFSP) is a routinely recorded measure of a child's development completed at the end of their first school year, for all children attending school in England and Wales. Despite widespread use for research and educational purposes, the measurement properties are unknown. This study examined the internal consistency and structural validity of the EYFSP, investigating whether the summed item-level scores, which we refer to as the 'total score', can be used as a summary of children's developmental health. It also examined predictive validity of the total score with respect to later academic attainment and behavioural, social, and emotional difficulties. The data source was the longitudinal prospective birth cohort, Born in Bradford (BiB), and routine education data were obtained from Local Authorities. The internal consistency and structural validity of the EYFSP total score were investigated using Confirmatory Factor Analysis and a Rasch model. Predictive validity was assessed using linear mixed effects models for Key Stage 2 (Maths, Reading, Grammar/Punctuation/Spelling), and behavioural, social, and emotional difficulties (Strengths and Difficulties Questionnaire). We found that the EYFSP items demonstrated internal consistency, however, an Item Response model suggested weak structural validity (n = 10,589). Mixed effects regression found the EYFSP total score to predict later academic outcomes (n = 2711), and behavioural, social, and emotional difficulties (n = 984). This study has revealed that whilst caution should be applied for measurement of children with close to 'average' ability levels using the EYFSP, the EYFSP total score is an internally consistent measure with predictive validity.

The impact of surgical interventions on lumbar disc herniation (LDH) is often assessed using objective functional impairment (OFI) tests like the five-repetition sit-to-stand (5R-STS) test. This study calculates the minimum clinically important difference (MCID) for 5R-STS improvement in patients with LDH one year after surgery.

Adult patients with LDH scheduled for surgery were prospectively recruited from a Dutch short-stay spinal clinic. The 5R-STS time, Oswestry Disability Index (ODI), Roland-Morris Disability Questionnaire (RMDQ), Numeric Rating Scale for back and leg pain, EQ-5D-3L health-related quality of life questionnaire and EQ5D-VAS were recorded preoperatively, at 6-weeks and 1-year post-operatively. The MCID was calculated using anchor-based methods (within-patient change; between-patient change; and receiver-operating characteristic approaches) and distribution-based methods (0.5 standard deviation (SD); effect size; standard error of measurement; standardized response mean; and 95% minimum detectable change (MDC)). The final MCID value was based on the "gold standard": an averaging of the anchor-based methods using ODI and RMDQ as the closest available anchors.

We prospectively recruited 134 patients. One-year follow-up was completed by 103 (76.8%) of patients. The MCID values derived using different methods varied from 0.7 to 5.1 s (s). The final, averaged, anchor-based MCID for improvement was 3.6 s. Within distribution-based methods, 95% MDC and 0.5SD approach, yielded an MCID of 3.0 and 3.8 s, respectively, aligning closely with the overall anchor-derived MCID for 5R-STS.

In a patient with LDH, an improvement in 5R-STS performance of at least 3.6 s can be regarded as a clinically relevant improvement.

Chronic low back pain is a prevalent condition that is treated commonly with radiofrequency neurotomy (RFN) after diagnostic targeting with medial branch blocks (MBB) or intra-articular (IA) injection.

We evaluated the long-term therapeutic value of MBB and IA injection of steroids for relief from chronic low back pain beyond the current diagnostic utility.

This was a retrospective propensity-matched cohort study from a single physician injection census at a tertiary care hospital. A total of 460 patients receiving MBB (n=383) or IA injection (n=77) in 2013-2020 were included. Primary outcome measures were patient-reported outcomes (PROs) at the time of injection, and follow-up at three and six months with the Numerical Rating Scale (NRS), PRO Measurement Information System (PROMIS)-Mental Health (MH), PROMIS-Physical Health (PH), and the Patient Health Questionnaire (PHQ)-9 scores. The same PROs at the one-year follow-up were the secondary outcome measures. Propensity weighting was performed to balance MBB and IA injection groups over several demographic and clinical categories.

Significant improvements in NRS (p=<0.001) were reported at the three-month, six-month, and one-year follow-ups, while significant improvements in PROMIS-PH scores (p=0.015) were identified at three and six months post injection.

Our results suggest that MBB and IA injection have potential therapeutic benefits for chronic low back pain for at least six months post injection. These results suggest that there is value in these diagnostic modalities therapeutically beyond the acute time frame. These results lay the groundwork for additional investigations into treatment options for patients affected by chronic low back pain.

The minimal clinically important difference (MCID) is a threshold above which a score change would represent a change in symptoms that is noticeable by patients, and it has become a standard approach in the interpretation of clinical relevance of changes in PROMs at a population level. Given the lack of a methodological gold standard, high variability is the main limitation of MCID. Reporting both anchor and distribution-based MCID estimates is a strategy that guarantees both patient-perceived clinical relevance and statistical significance.

To describe the outcomes of an interdisciplinary multimodal pain treatment (IMPT) for chronic musculoskeletal pain (CMP) patients up until 12 months post-treatment.

Data were gathered during routine clinical practice during a 3-year period (2019-2021) at six Dutch rehabilitation centres. Assessments included patient-reported outcome measures for multiple domains including disability, pain and fatigue. Longitudinal data were analysed using repeated-measures models and by quantifying responder rates.

Included were 2309 patients with a mean age of 43.7 (SD 12.9) years, of which 73% female. All outcomes showed significant improvements at each timepoint. At discharge, large effect sizes were found for disability, average and worst pain, fatigue and health-related quality of life. Improvements were largely sustained at 12-months. Relatively large proportions of patients had clinically relevant improvements after treatment (pain-related disability: 60%; average pain: 52%; worst pain: 37.4%; work capacity: 50%; concentration: 50%; fatigue: 46%). Patients who received a treatment extension showed further improvements for all outcome measures, except average pain.

At group level, all outcomes significantly improved with mainly large effect sizes. The results were mostly sustained. The proportion of patients showing clinically relevant improvements tends to be larger than previously reported for mixed CMP patients.

To systematically review the variability of reporting of clinically significant outcomes (CSOs) including minimal clinically important difference (MCID), substantial clinical benefit (SCB) and patient acceptable symptom state (PASS), and threshold calculation methods following surgical treatments for cartilage defects of the knee. A systematic review was performed using the 2020 Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines. A literature search was performed on August 12th, 2024, using the PubMed, Embase, and Scopus online databases for human clinical studies with publication dates ranging from 2010 to 2024 reporting on MCID, SCB, or PASS following surgical treatments for cartilage defects of the knee. Study demographics, patient-reported outcome measures (PROMs), CSO thresholds, and methods of CSO calculation were collected. A total of 19 studies (n = 3659 patients) with an average follow-up of 36.5 months were included. A total of 14 (93.3%) studies reported MCID, six (31.8%) studies reported SCB, and five (26.3%) studies reported PASS. Of the included studies, 16 (80%) referenced another study for calculating their CSO whereas three (20%) studies calculated their own CSO. A total of 16 different PROMs were reported among the included studies. Eight studies utilized the anchor-based method for CSO calculation, ten studies used both the anchor and the distribution-based methods for calculation, while only one study used the distribution-based method alone. There is considerable variation in the reporting and calculation methods of MCID, SCB, and PASS for different PROMs following surgical treatments for cartilage defects of the knee.Level of Evidence: IV, Systematic Review of Level I-IV studies.

To assess sample size calculation reporting in randomized controlled trials (RCTs) investigating prehabilitation interventions in oncological surgery patients.

A systematic literature search was performed in multiple medical databases from inception to April 2023, including MEDLINE, Embase, The Cochrane Library, CINHAL, AMED, and PsychINFO.

The inclusion criteria used were RCTs evaluating effectiveness of exercise, nutrition, and/or psychological interventions on postoperative outcomes of adult patients undergoing oncological surgery.

Two authors (DS and SV) extracted information on the sample size calculation parameters, including type I error (α), power (1-β), mean (or mean difference between randomization arms), and variance (eg, standard deviation) for continuous outcomes, and event rates or event rate difference between randomization arms for dichotomous outcomes. When possible, we recalculated the sample size required using the collected data, given a 10% margin of error.

Of the 59 included publications (58 RCTs), 26 (44%) reported sufficient information to complete sample size recalculation. Of those that provided sufficient information allowing us to recalculate the required sample size, 11 (42%) were within a 10% margin of the reported sample size, whereas 9 (35%) were >10% higher than reported sample size and 6 (23%) were >10% lower than reported sample size.

Over half of the published RCTs in this field exhibit poor sample size calculation reporting. Most RCTs that report sufficient sample size information were underpowered. More stringent reporting requirements are necessary.

The utility of patient-reported outcome measures (PROMs) has been well established, but their interpretation relies on population-specific definitions of meaningful improvement. As such, the minimum clinically important difference (MCID), substantial clinical benefit (SCB), and patient-acceptable symptom state (PASS) thresholds have become prominent metrics in the orthopaedic evidence to ascribe clinical relevance to numeric PROM scores. Studies assessing outcomes of periacetabular osteotomy (PAO) relative to the MCID and PASS have previously evaluated patients against thresholds defined for hip arthroscopy for the treatment of femoroacetabular impingement or distribution-based MCID calculations. These scores may not accurately reflect the status or expectations of patients with a different symptom profile undergoing open hip preservation surgery.

For patients treated with PAO, we sought to (1) define the MCID, SCB, and PASS threshold values for the mHHS (modified Harris hip score) and International Hip Outcome Tool 12 (iHOT-12) using anchor-based methods; (2) assess the validity of MCID and SCB estimates against minimal detectable change (MDC) values; and (3) determine the proportion of patients who achieved a clinically meaningful threshold.

Between February 2011 and May 2023, a total of 690 patients underwent PAO for symptomatic acetabular dysplasia at one institution and were included in a longitudinally maintained hip preservation registry. The cohort used to define and validate MCID, SCB, and PASS threshold values consisted of those with a completed postoperative anchor questionnaire, which yielded 456 patients as potentially eligible. An additional 139 patients were excluded because of missing mHHS or iHOT-12 scores during the eligibility window (1 to 2 years postoperatively), leaving 70% (317 of 456) of patients to define and validate MCID, SCB, and PASS at a mean ± SD of 1.0 ± 0.3 years of follow-up. A minimum 1-year follow-up was chosen to reduce recall bias. The cohort for defining MCID, SCB, and PASS (94% [298 of 317] women, mean ± SD age at time of surgery 27 ± 8 years) included 21% (68 of 317) of patients with prior ipsilateral surgery. From those registry patients without complete anchor questionnaires, 37% (137 of 373) were identified with pre- and postoperative PROM scores at a mean ± SD of 1.0 ± 0.9 years of follow-up to form the sample for assessing the proportion of patients achieving a clinically meaningful threshold. The MCID, SCB, and PASS thresholds for the mHHS and iHOT-12 were calculated through an anchor-based approach, using area under the receiver operating curve to determine cut points that best identified positive responses, according to quality of life-based anchor questions. The MDC was calculated with confidence intervals (CIs) reflecting 80%, 90%, and 95% certainty to determine the smallest change in the PROM scores that can be considered above the level of measurement error. The validity of MCID estimates was assessed by confirming that they exceeded corresponding MDC values. The validity of SCB estimates were assessed by confirming that they exceeded corresponding MCID values. The proportion of patients achieving a clinically meaningful threshold was determined by calculating the percentage of patients who met the defined anchor-based scores.

The MCID, SCB, and PASS thresholds for the mHHS were 18, 23, and 71, respectively. The MCID, SCB, and PASS thresholds for the iHOT-12 were 26, 42, and 65, respectively. The MDC ranged from 8 to 12 for the mHHS and 10 to 16 for the iHOT-12. The MCID values for the mHHS and iHOT-12 exceeded corresponding values of the MDC at all CIs. The SCB thresholds exceeded all corresponding MDC and MCID values. Across the mHHS and iHOT-12, the proportion of patients who achieved an MCID at the first time point ranged from 60% to 73%, the proportion of patients who achieved the SCB ranged from 49% to 56%, and the proportion of patients who achieved the PASS threshold ranged from 55% to 79%. Among the cohort for defining MCID, SCB, and PASS, the proportion of patients achieving any MCID, SCB, or PASS was 79%, 66%, and 81%, respectively. Among the sample for assessing the proportion of patients achieving a clinically meaningful threshold, the proportion achieving any MCID, SCB, or PASS threshold was 74%, 58%, and 72%, respectively.

We found that using a sample of patients undergoing PAO, the anchor-based values for the MCID and SCB were generally larger than previous distribution- and anchor-based scores that have been defined for hip preservation, whereas PASS threshold scores were similar. All MCID and SCB thresholds exceeded corresponding MDC values, confirming these scores to be valid estimates. These metrics provide more rigorous, procedure-specific definitions for the evaluation of treatment success and failure after PAO. As anchor-based metrics are defined based on patients' perceptions, they should be used preferentially for postoperative assessment over distribution-based scores.

Level III, therapeutic study.

Tools that can reliably measure changes in the perception of tinnitus following interventions are lacking. The minimum masking level, defined as the lowest level at which tinnitus is completely masked, is a candidate for quantifying changes in tinnitus perception. In this study, we aimed to determine minimal clinically important differences for minimum masking level.

A 3-month tinnitus intervention combining counseling and sound therapy was conducted in 74 participants with chronic tinnitus. Minimum masking levels were measured at baseline and 3 months. The clinical global impression was evaluated at 3 months to measure changes in participants' self-perception of tinnitus. The minimal clinically important difference of the minimum masking level was calculated using anchored-based, effect size, standard error measurement, and receiver operating characteristic curve analysis.

The minimal clinically important difference analysis of the minimum masking level yielded a -5.5 dB SL from the receiver operating characteristic curve, a -8.1 dB SL from the standard error measurement, a -9.2 dB SL from the effect size, and a -10.3 dB SL from the anchor-based analysis. Of these, the minimal clinically important difference value with optimized sensitivity (.704) and specificity (.957) was a -5.5 dB SL, determined using receiver operating characteristic analysis.

The proposed minimal clinically important difference value of the minimum masking level (-5.5 dB SL) provides a good level of sensitivity and specificity. Therefore, the minimum masking level may be an alternative for measuring changes in tinnitus perception.

https://doi.org/10.23641/asha.28156229.

Fibromyalgia is a condition characterised by disabling levels of pain of varying intensity. Aerobic exercise may play a role in reducing pain in these patients. The aim of this review is to assess the dose of aerobic exercise needed, based on the frequency, intensity, type, time, volume and progression (FITT-VP) model, to obtain clinically relevant reductions in pain.

A systematic review and meta-analysis of randomised clinical trials was conducted in the Web of Science (WoS), PEDro, PubMed and Scopus databases, the search having been conducted between July and October of 2023. Risk of bias was assessed with the Cochrane Risk of Bias assessment tool 2.

Seventeen studies were included. The risk of bias varied, with six studies showing low risk; five, some concerns; and six, high risk. Aerobic exercise interventions were analysed using the FITT-VP model. Frequency ranged from 1 to 10 times per week, intensity varied from light to vigorous, and the types of exercise included music-based exercise, interval training, pool-based exercise, stationary cycling, swimming and walking. The intervention durations ranged from 3 to 24 weeks, with session lengths ranging from 10 to 45 min. Most of the studies presented significant differences, favouring aerobic exercise (MD -0.49; CI [-0.90, -0.08; p = 0.02]), with moderate to low heterogeneity in subgroup analyses.

The study findings underscore the efficacy of aerobic exercise in alleviating pain among fibromyalgia patients, advocating for tailored exercise dosing to optimise adherence and outcomes.

Individuals with fibromyalgia should engage in aerobic exercises two to three times weekly, for twenty-five to forty minutes in each session, aiming for more than a hundred minutes per week. They should start at low intensity, gradually increasing to higher intensities over six to twelve weeks, for optimal pain management. Exercise types should be selected in collaboration with the patient and based on personal preferences and accessibility, such as walking, and swimming, to ensure long-term adherence to the regimen.

This study aimed to investigate the correlation between mental and physical health-related quality of life and the outcomes of conservative treatment in patients with frozen shoulder (FS).

This was a two-center retrospective study. It included 84 consecutive patients who underwent a 3-month treatment comprising education, physical therapy, and corticosteroid-anesthetic injections. Changes in range of motion (ROM) and Shoulder Pain and Disability Index (SPADI) scores, measured at baseline and after 3 months, were selected as dependent variables. Data on age, sex, Body Mass Index, duration of symptoms, dominant affected limb, and Short Form-36 (SF-36) subscales were gathered at baseline and investigated as prognostic factors. Backward stepwise regression models were used to identify significant associations.

At 3-month follow-up, all the patients showed significant improvement. Higher SF-36 General Health, Mental Health and Social Functioning scores at baseline were associated with a greater beneficial change in ROM and SPADI. In contrast, lower SF-36 Bodily Pain and Role Emotional scores were found to be associated with greater improvement.

The study findings indicate that the self-perceived mental and physical health of patients have a significant impact on both subjective and objective clinical outcomes and healthcare professionals should take these aspects into account.

Prognostic Level II.

The minimal important difference (MID) is vital to consider when interpreting the clinical importance of observed changes from surgical interventions assessed by patient-reported outcome measures (PROMs). There is no accepted standard for how to calculate MIDs, and uptake in the plastic surgery literature is unknown, leading to methodologic and interpretation issues.

Medline and Embase were searched to identify all plastic surgery randomized controlled trials (RCTs) using PROMs as outcomes and MID estimation studies for PROMs used by RCTs. Included studies were assessed for uptake and application of MIDs, and MID estimation methodology and values were categorized.

A total of 554 RCTs using PROMs as outcomes were identified. Of these, 419 RCTs had the possibility of incorporating a previously published MID. The uptake rate of MIDs was 11.5% ( n = 48 of 419). The most common ways MIDs were applied were to calculate sample size (37.5%) or to determine whether results were clinically important (35.4%). A total of 99 studies estimating MID values for the most common PROMs in plastic surgery, based on our review, were analyzed. The most common estimation methodologies were receiver operating characteristic curve analysis (49%), change difference (31%), and SD (25%).

This review highlights limited uptake and application of MIDs in plastic surgery. The authors propose 4 major barriers: (1) no repository of published MIDs for PROMs used in plastic surgery exists; (2) available MIDs are not specific to plastic surgery populations; (3) high heterogeneity in MID estimation methodology was present; and (4) there are wide ranges in MID values, with no superior choice identified.

Cognitive dysfunction is a major symptom in schizophrenia associated with social skills. It has been reported that cognitive rehabilitation can improve cognitive dysfunction. The Brief Assessment of Cognition in Schizophrenia-Japanese version (BACS-J) is often used as an outcome measure to assess the effectiveness of cognitive rehabilitation. However, the minimal clinically important difference (MCID) in the BACS-J composite score has not been reported. Therefore, we conducted this study to calculate a preliminary MCID in the BACS-J composite score and confirm the feasibility of retrospective data collection and analysis for future large-scale studies.

The medical records of patients with schizophrenia who underwent cognitive rehabilitation were retrospectively surveyed. BACS-J data were collected at the beginning and end of the cognitive rehabilitation, and Clinical Global Impression-Improvement (CGI-I) data obtained at the end of the cognitive rehabilitation were evaluated retrospectively. To calculate the MCID in the BACS-J composite score using distribution-based methods, the standard error of measurement was calculated as a characteristic of the scale itself. To calculate the MCID using anchor-based methods, the mean change in BACS-J score corresponding to "minimally improved" on the CGI-I was determined.

Twenty-eight patients were included in this study, and BACS-J data were collected from all patients. The CGI-I was completed by 11 patients, 3 of whom showed "minimally improved" according to their CGI scores. Distribution-based methods applied to the data of 28 patients revealed an MCID of 0.735 for the BACS-J composite score. Anchor-based methods were ultimately not applied because the sample size was insufficient.

This study confirmed that CGI and BACS-J data can be collected and analyzed retrospectively. According to distribution-based methods, an increase of approximately 0.7 in the BACS-J composite score can be considered clinically meaningful. Future studies with larger sample sizes using both calculation methods could provide more accurate MCID.

To understand the potential benefits of emerging Alzheimer's disease (AD) therapies within and beyond clinical trial settings, there is a need to advance current outcome measurements into meaningful information relevant to all stakeholders. The relationship between the impact on disease biology and clinically measurable outcomes in cognition, function, and behavior must be considered when defining the meaningful benefit of early AD therapies. In this review, we discuss: (1) the lack of consideration for biomarkers in the current concept of meaningfulness in AD; (2) the lack of gold standards for determining minimal biologically and clinically important differences (MBCIDs) in AD trials; (3) how the treatment benefits of disease-modifying treatments are cumulative and increase over time; and (4) the different concepts of meaningfulness among key stakeholders. This review utilizes the future clinical biological framework of AD and aims to further integrate and expand the parameters of meaningful benefits toward a precision medicine framework. HIGHLIGHTS: Definition of meaningful benefit from Alzheimer's disease (AD) treatment varies across disease stage and stakeholder perspectives. Observable and meaningful outcomes must consider the clinical-biological nature of AD. Statistically significant effects or outcomes do not always equate to clinically meaningfulness. Assessment tools must reflect stage-specific subtle changes following treatment. Real-world evidence will support consensus, definition, and interpretation of clinical meaningfulness.

To calculate the minimal clinically important difference (MCID) for the Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI).

Prospective cohort study.

A single tertiary care balance and falls center.

Fifty-three subjects meeting Barany Society criteria for vestibular migraine (VM) or probable VM were included and divided into 3 treatment groups. Treatment was not standardized, instead, management was decided individually between each patient and their provider. All subjects completed VM-PATHI before and after intervention. A Global Rating of Change (GRoC) questionnaire was also completed following intervention. Anchor-based methods, using a GRoC questionnaire, were utilized to estimate the MCID that produced the highest sensitivity and specificity on a receiver operating characteristic (ROC) curve.

Forty-three subjects were classified as responders and 10 were classified as nonresponders. The mean VM-PATHI pretreatment score minus the posttreatment score between the responders (mean = 14, SD 13) and nonresponders (mean = 4 SD = 12) was statistically significant (mean difference = 10, 95% confidence interval, CI [1, 20], P = .03). The VM-PATHI score change cutoff that best differentiated between responders and nonresponders was a VM-PATHI change of 6. Thus, the MCID was defined as a change of 6 points (sensitivity = 72%, specificity = 70%). The area under the ROC curve was 0.89, 95% CI [0.80, 0.98], which demonstrates an excellent ability for the VM-PATHI score change to discriminate between responders and nonresponders. The average change in VM-PATHI scores was 9 points (SD 11) for those with "a little better" rating on the GRoC, 14 points (SD 14) for those with a "moderately better" rating, and 20 points (SD 13) for those with a "very much better" rating.

Patients with VM are likely to demonstrate clinical improvement if their VM-PATHI score decreases by 6 or more.

Bioelectrical impedance is used clinically to assess body composition. To determine true (rather than chance/measurement error) change in bioelectrical impedance analysis measurements over time, it is necessary to know their least significant change. Least significant change represents values exceeding the 95% prediction interval of the precision error of repeat measurements. The least significant change of repeat bioelectrical impedance analysis measurements in children with obesity and metabolic dysfunction-associated steatotic liver disease is currently unknown.

This is a prospective, single-center, descriptive cohort study in youth 6-20 years of age with obesity and metabolic dysfunction-associated steatotic liver disease. Two same-day bioelectrical impedance analysis measurements were performed on a multifrequency, octopolar device (InBody 370). Fat mass and fat-free mass were adjusted for age using respective indices (dividing by height squared). Fasting status was determined by patient report. Descriptive statistics (medians with interquartile ranges and means with standard deviations and proportions) were used; the least significant change between repeat measurements with precision interval was calculated.

We recruited 43 patients (81% male; 33% Hispanic; median age: 14 years [interquartile range: 11-16]; median body mass index z score: 2.31 [interquartile range: 2.84-2.65]). A total of 60% were fasting, for a median of 12 h. The least significant change of fat mass index was 0.5 (precision interval: -0.4 to 0.5) kg/m2, fat-free mass index was 0.3 (precision interval: -0.3 to 0.3) kg/m2, and body fat percent was 1.5% (precision interval: -1.3 to 1.50). Fasting status affected least significant change measurements.

In youth with obesity and metabolic dysfunction-associated steatotic liver disease, repeat bioelectrical impedance analysis measurements beyond least significant change and precision interval determined in this study likely represent true changes in body composition over time, vs measurement error.

The minimal clinically important difference (MCID) is an important threshold to consider when evaluating the meaningfulness of improvement following an intervention. The JoyPop app is an evidence-based smartphone app designed to improve resilience and emotion regulation. Information is needed regarding the JoyPop app's MCID among culturally diverse youth.

This study aims to calculate the MCID for youth using the JoyPop app and to explore how the MCID may differ for a subset of Indigenous youth.

Youth (N=36; aged 12-18 years) were recruited to use the JoyPop app for up to 4 weeks as part of a larger pilot evaluation. Results were based on measures completed after 2 weeks of app use. The MCID was calculated using emotion regulation change scores (Difficulties in Emotion Regulation-Short Form [DERS-SF]) and subjective ratings on the Global Rating of Change Scale (GRCS). This MCID calculation was completed for youth overall and separately for Indigenous youth only.

A significant correlation between GRCS scores and change scores on the DERS-SF supported face validity (r=-0.37; P=.04). The MCID in emotion regulation following the use of the JoyPop app for youth overall was 2.80 on the DERS-SF. The MCID for Indigenous youth was 4.29 on the DERS-SF. In addition, most youth reported improved emotion regulation after using the JoyPop app.

These MCID findings provide a meaningful threshold for improvement in emotion regulation for the JoyPop app. They provide potential effect sizes and can aid in sample size estimations for future research with the JoyPop app or e-mental health technologies in general. The difference between overall youth and Indigenous youth MCID values also highlights the importance of patient-oriented ratings of symptom improvement as well as cultural considerations when conducting intervention research and monitoring new interventions in clinical practice.

The combination of high energy fractures, extensive soft tissue trauma, and high infection rates in pilon fractures of the distal tibia have long challenged surgeons. Despite the ample evidence, there is no consensus regarding the factors that may influence postoperative infections following surgical management of these fractures. This study aimed to investigate the risk factors for postoperative infections in patients undergoing surgical management for pilon fractures. This retrospective cohort study evaluated demographic variables, smoking status, nutritional status (i.e., pre-and postoperative albumin, pre-and postoperative white blood cell count, use of antibiotics, time to external fixation and ORIF, and hospital length of stay. A multivariate logistic regression model was used to predict risk factors associated with postoperative infection after fixation of a pilon fracture for several independent parameters. A receiver operator characteristic (ROC) curve was constructed, and a threshold was found for the investigated continuous variables, which were significant in the regression analysis. Overall, 416 patients following surgical management for a pilon fracture were identified. A multivariate logistic regression analysis revealed that preoperative albumin, preoperative WBC, and hospital length of stay were associated with postoperative infection following surgical management of pilon fractures. Thresholds determined by the Youden index were 3.05 for preoperative albumin levels, 12.65 for preoperative WBC levels, and 7.1 days for hospital length of stay. Furthermore, older patients were less prone to develop postoperative infection than younger patients. Lower preoperative albumin levels (< 3.05 mg/dL), higher preoperative WBC levels (>12.65 mg/dL), and a longer duration of hospitalization (>7.1 days) were related to an increased risk for postoperative infection after fixation of a pilon fracture.

The minimal clinically important difference (MCID), patient-acceptable symptom state (PASS), and substantial clinical benefit (SCB) are designed to prioritise clinically significant outcomes that demonstrate true clinical benefit rather than relying solely on statistical significance. These instruments aid clinicians in understanding the patient's perspective, allowing healthcare professionals to set treatment goals that align with patients' desires and expectations. This systematic review analysed tools to estimate the clinical relevance of the most commonly used PROMs to assess patients following surgical knee ligament reconstruction.

This study was conducted according to the 2020 PRISMA statement. In January 2024, the following databases were accessed: PubMed, Web of Science, and Embase. No time constraint was set for the search. All the clinical studies investigating tools to assess the clinical relevance of PROMs in knee ligament surgery were accessed. Only studies which evaluated the MCID, PASS, and SCB were eligible. The PROMs of interest were: International Knee Document Committee (IKDC), Knee Injury and Osteoarthritis Outcome Score (KOOS) and its related subscales activity of day living (ADL), pain, quality of life (QoL), sport and recreational, and symptoms (Roos et al. in J Orthop Sports Phys Ther 28:88-96, 1998), Lysholm knee scoring scale, Short Form 12 (SF-12) and its related mental and physical component subscales, Tegner Activity Scale.

Seven non-RCT investigations, three with a prospective and four with a retrospective study design, were selected for inclusion in the present review, including 1,414 patients. The overall risk of bias was low to moderate in 71.4% (5 of 7) and serious in 28.6% (2 of 7) of the studies assessed in the present investigation, indicating a broadly acceptable methodological quality. The IKDC reported an MCID of 13.8/100, the KOOS 8.0/100, the Lysholm 9.9/100, and the Tegner Activity Scale 0.5/10.

This systematic review demonstrated that more dependable scientific data, appropriate study methodology, and adequate reporting of MCID, SCB, and PASS in surgical knee ligament reconstruction is necessary. The IKDC score, the Lysholm score, and the Tegner activity scale were the only instruments with multiple studies reporting values. Level of evidence Level IV, systematic review and meta-analysis.

To obtain priority consensus for outcome measures of oral corticosteroid treatment of preschool wheeze that represent stakeholder groups.

(1) A systematic review to identify a set of outcome measures; (2) an international survey for healthcare professionals (HCPs) and a nominal group meeting with parents; (3) a final consensus nominal group meeting with key HCPs (trial investigators and paediatric emergency medicine clinicians) and the same parent group.

Consensus priority of treatment outcome measures, outcome minimal clinically important differences (MCIDs) and level of concerns about adverse effects.

Through an iterative process engaging HCPs and parents, the final consensus on a primary outcome was Wheezing Severity Score (WSS). Secondary outcomes prioritised as a revisit to general practice/emergency department, rehospitalisation, length of hospital stay (LOS), time back to normal, doses of short-acting beta-agonists and additional steroid course. Compared with placebo, clinicians considered the median MCID change in WSS at 4 and 12 hours as 40% (IQR 29-51%) and 50% (37-63%) and 5 hours (4-6 hours) for LOS, and 2 days (2-3 days) for a time back to normal. Parents identified MCIDs which were frequently longer than physiologically observed impacts in trials. Concerns about multiple steroid doses were most prevalent.

Stakeholders prioritised change in WSS as the most favourable outcome measure. Our study demonstrated the potential of parent/patient engagement in co-creating patient research outcomes. Incorporating this result in the design of future clinical research will provide a more holistic assessment of the impact of treatment while ensuring relevant primary research outcomes.

Purpose: The study sought to compare the number of cycles (NOS) for the first and second thirty-seconds (FASTS) within 1 min of accommodative facility (AF) and vergence facility (VF) testing to explore possibilities of reducing testing time to 30 s. Methods: In this cross-sectional study, a multistage sample of school children (aged 8-17 years) was taken through ocular-visual screening. Eligible participants (586) underwent refraction, stereo-acuity measurement, AF testing using ± 2D lens flippers, and VF testing using 3Δ BI/12Δ BO flipper prisms. The NOS within the FASTS of AF and VF tests were compared, respectively. Results: A statistically insignificant mean difference of 0.01 cycles was found between the NOS for the FASTS of monocular AF in the right eye (Wilcoxon Signed Rank test, p = .715). Statistically significant differences of 0.06, 0.14, and 0.09 cycles (Wilcoxon Signed Rank test, p < .05) which are not clinically meaningful were found for monocular AF in the left eye, binocular AF, and VF with no level of agreement on Bland Altman analysis, respectively. There were no clinically meaningful differences between the first 30-s cycles multiplied by two (FTSMT) and the full 1-min test period cycles for monocular AF, binocular AF, and VF. Conclusion: The FTSMT approach may be applied during gross screening to shorten testing time as further study is recommended for its diagnostic validity.

Adolescent idiopathic scoliosis (AIS) is the most common type of scoliosis, affecting 1-4% of adolescents. The Scoliosis Research Society-22R (SRS-22R), a health-related quality-of-life instrument for AIS, has allowed orthopedists to measure subjective patient outcomes before and after corrective surgery beyond objective radiographic measurements. However, research has revealed that there is no significant correlation between the correction rate in major radiographic parameters and improvements in patient-reported outcomes (PROs), making it difficult to incorporate PROs into personalized surgical planning.

The objective of this study is to develop an artificial intelligence (AI)-enabled surgical planning and counseling support system for post-operative patient rehabilitation outcomes prediction in order to facilitate personalized AIS patient care. A unique multi-site cohort of 455 pediatric patients undergoing spinal fusion surgery at two Shriners Children's hospitals from 2010 is investigated in our analysis. In total, 171 pre-operative clinical features are used to train six machine-learning models for post-operative outcomes prediction. We further employ explainability analysis to quantify the contribution of pre-operative radiographic and questionnaire parameters in predicting patient surgical outcomes. Moreover, we enable responsible AI by calibrating model confidence for human intervention and mitigating health disparities for algorithm fairness.

The best prediction model achieves an area under receiver operating curve (AUROC) performance of 0.86, 0.85, and 0.83 for individual SRS-22R question response prediction over three-time horizons from pre-operation to 6-month, 1-year, and 2-year post-operation, respectively. Additionally, we demonstrate the efficacy of our proposed prediction method to predict other patient rehabilitation outcomes based on minimal clinically important differences (MCID) and correction rates across all three-time horizons.

Based on the relationship analysis, we suggest additional attention to sagittal parameters (e.g., lordosis, sagittal vertical axis) and patient self-image beyond major Cobb angles to improve surgical decision-making for AIS patients. In the age of personalized medicine, the proposed responsible AI-enabled clinical decision-support system may facilitate pre-operative counseling and shared decision-making within real-world clinical settings.

Lumbosacral hemivertebra (LSHV) is a complex and unique congenital spinal deformity characterized by early severe trunk imbalance and progressive compensatory curve. Previous studies have proved the efficiency of posterior LSHV resection. However, the optimal timing for surgical intervention of LSHV still remains controversial. Few studies compare the surgical outcomes in patients of different age groups.

To evaluate the influence of posterior-only LSHV resection surgery timing on clinical and radiographic results.

Retrospective analysis.

We retrospectively analyzed 58 LSHV patients undergoing posterior-only LSHV resection with short-segment fusion at our institution between 2010 and 2020, with a mean follow-up of 7.5 years.

The following data were observed for all cases: patient demographics, clinical outcomes measured by operating time, intraoperative blood loss, complications, and Health-Related Quality of Life, radiographic parameters included Cobb angles, trunk shift and sagittal spinal parameters.

From 2010 to 2020, a consecutive series of 58 LSHV patients treated by posterior LSHV resection with short segmental fusion were investigated retrospectively, with a 7.5-year average follow-up period. Patients were stratified into 2 groups based on the timing of surgery: Group E (≤6 years old, representing the early-surgery) and Group L (>6 years old, representing the late-surgery). Radiographic assessments included pre- and postoperative measurements of main scoliosis, compensatory scoliosis, trunk shift, and sagittal balance parameters. Operative data, perioperative complications and SRS-22 questionnaires were also collected.

Compared to Group L, Group E exhibited a lower intraoperative blood loss (p<.001), higher final main curve correction rate (p=.037), smaller postop compensatory curve (p=.031), higher sagittal vertical axis correction rates at immediate postop (p=.045) and last follow-up (p=.027), and lower implant failure complications incidence (p=.006).

This study suggested that early surgical intervention in LSHV patients can achieve better correction outcomes, while reducing blood loss and postoperative complications in a large-scale cohort.

The demand for SIJ fusion among obese patients has grown substantially. However, the clinical relevance of obesity in the context of SI joint fusion has not been well investigated specifically, whether there is a BMI cutoff above which the benefit-risk ratio is low.

Adult patients ≥ 21 years of age who underwent minimally invasive SIJ fusion between 2020 and 2023. Participants were classified using the National Institutes for Health body mass index (BMI). Patients with a BMI of 30 to 39 with no significant comorbidity are considered obese, patients with a BMI of 35 to 39 with a significant comorbidity or a BMI of 40 or greater are considered morbidly obese. All subjects completed the Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) at baseline and 12 months. One-way analysis of variance was used to examine the impact of BMI category on score changes.

Overall, mean VAS improved at 12 months by 2.5 points (p < .006). Over the 12-month follow-up period, BMI category did not impact mean improvement in VAS (ANOVA p = .08). Mean ODI at 12 months improved by 23.2 points (p < .001). BMI category did impact mean improvement in ODI (ANOVA p = .03).

This study demonstrates similar benefits across all BMI categories. This data suggests that obese patients do benefit from minimally invasive SIJ fusion, specifically the 35-40 BMI cohort of patients, and should not be denied this procedure based on arbitrary healthcare organizations BMI criteria.

Despite most patients reporting optimal knee function after anterior cruciate ligament reconstruction (ACLR), not all return to their pre-injury level of sport, often due to psychological factors. The ACL-Return to Sport after Injury Scale (ACL-RSI) was developed to measure the emotions, confidence in performance, and risk appraisal among athletes returning to sport. The purpose of this study was to determine the Patient Acceptable Symptom State (PASS) threshold for the ACL-RSI in patients undergoing ACLR.

Patients with an ACL injury that required surgical reconstruction were included in this prospective study. All patients underwent ACLR with a bone-patellar tendon-bone autograft and completed the ACL-RSI 12 months postoperatively. An anchor-based approach was used to generate a receiver operating characteristic curve and establish the PASS threshold. Multivariable regression analyses were used to evaluate the effect of age, sex, and baseline score on likelihood of achieving PASS.

A total of 113 patients (37% female) with a mean age of 28.1±8.2 years and a mean body mass index of 24.7±3.5 kg/m2 were included. At 12 months postoperatively, the threshold value for the PASS of the ACL-RSI was 40 (robust area under the curve: 0.89; sensitivity: 81%; specificity: 85%). Baseline score, sex, and age had no significant influence on achieving PASS at 12 months postoperatively.

In a group of patients undergoing ACLR with bone-patellar tendon-bone autograft, the PASS threshold value was 40 for the ACL-RSI at 12 months postoperatively. The PASS value for the ACL-RSI established from this study can be useful for designing future clinical trials. [Orthopedics. 2025;48(1):20-24.].

Tailoring resources of peripheral vascular interventions (PVIs) to those who stand to gain the most would allow for more equitable and value-based care. One way of evaluating the benefit of PVIs in patients with symptomatic peripheral artery disease is evaluating their health status and identifying predictors of health status response 12 months after the intervention.

Patients who underwent femoropopliteal PVI between March 2005 and August 2008 from the Zilver PTX randomized trial and single-arm study were combined into a single cohort for secondary data analysis. The preprocedural and 12-month health status was assessed by the EuroQol-5D-3 L (EQ-5D). First, we evaluated the 12-month EQ-5D Index (per 1-unit increase), adjusted for treatment condition and patient characteristics using a linear regression. Second, using the minimally clinically important difference threshold for the EQ-5D Index, we identified 12-month nonresponders (worsened or no change) vs responders (improved) and conducted an adjusted logistic regression model.

A total of 513 patients were included (mean age: 67.8 ± 9.2 years; 25.1% female), with 17.8% U.S. and 82.2% non-U.S. global enrollment sites. The minimally clinically important difference for the EQ-5D was 0.058. For 12-month health status after PVI, a total of 57.9% improved, 31.4% experienced no change, and 10.7% worsened, relative to their preprocedural health status. Patients who were more likely to be nonresponders were more likely to have a history of carotid artery disease or were located at a U.S. enrolling center.

The majority of patients reported improved or stable health status after femoral-popliteal PVI. Approximately 4 in 10 patients were nonresponders, with the highest risk for nonresponse including individuals with existing carotid disease or those undergoing PVIs in the U.S. vs non-U.S.