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The epidemiology data and global burden of diabetic foot disease underscores the need for effective prevention strategies, which requires an early diagnosis. Patient-reported outcome measures are instruments based on a simple format, which favours their application. Currently, there is an absence of instruments with a broad enough scope to capture the diverse aspects involved in diabetic foot disease. To develop a questionnaire for the assessment of patients with diabetic foot disease and carry out an analysis of its validity and reliability. The study was developed in two stages. Stage 1: the Delphi Panel was composed of 22 experts. The questionnaire is made up of 25 questions selected, after three rounds, from an initial sample of 68 questions. Stage 2: A validation study was performed. With a sample of 273 subjects, an exploratory factor analysis and an analysis of internal consistency, items response, and validity were carried out using the Diabetes Quality of Life, SF-12v2, Foot Function Index and EuroQol EQ5D questionnaires. Measurements of error and sensitivity to change were also analyzed. A 25-item questionnaire (DiaFootQ) was developed. It comprised two dimensions: 1) lifestyle and function; and 2) footwear and foot self-care. Sample (n=273) mean age was 69.77 years (±11.08). The internal consistency of DiafootQ was α=0.916, and item response values were ICC=0.862–0.998. External validity correlation levels ranged from r=0.386 to r=0.888. DiaFootQ was developed. Integrating the main aspects involved in diabetic foot disease could help to detect more accurately the risk or severity of these patients. DiaFootQ is a well-structured, valid, and reliable tool whose use should be promoted in clinical and research settings. • The DiaFootQ is a new instrument for the assessment and monitoring of patients with diabetic foot disease. • A thorough Delphi method was used for the DiaFootQ development. • DiaFootQ is highly innovative since it provides reports from the multiple aspects of diabetic foot disease. • The DiaFootQ proved to have adequate face, content, internal and external validity. [ABSTRACT FROM AUTHOR]

Patients with class III malocclusion often exhibit mandibular prognathism and complain of "prognathic appearance". The overall positive effects of orthognathic surgery on facial appearance have been demonstrated using patient-reported outcome measures (PROMs), but studies investigating the correlation between subjective PROMs results and objective measurements of imaging studies are sparse in the literature. This study recruited consecutive patients with skeletal class III malocclusion who underwent two-jaw orthognathic surgery between January 2016 and January 2021. The PROMs survey was conducted focusing on subjective perception of mandibular appearance. Lateral cephalometric images were measured to examine the correlation with the PROMs results. A total of 96 patients were eligible for this study. Of these, 74 patients (77.1%) reported complete correction of prognathic appearance postoperatively, whereas 22 patients (22.9%) perceived residual prognathic appearance. In a comparison of postoperative measurements between completely and incompletely satisfied patients, there were significant differences in SNB, ANB, convexity, facial angle, Nv-B, Nv-Pog, SN'B', soft tissue facial angle, lip–chin–throat angle, N'v-B′, and N'v-Pog'. The PROM results were significantly associated with the objective measurements of imaging studies. Investigating the correlation between PROMs and objective measurements enables integration of patients' perception of the outcomes into future therapeutic strategy and surgical planning, contributing to the enhancement of patient satisfaction. [ABSTRACT FROM AUTHOR]

Glenoid component loosening remains the most common reason for revision of anatomic total shoulder arthroplasty (aTSA). We assessed early clinical and radiographic outcomes following aTSA using a press-fit short stem and a peripherally enhanced fixation glenoid. 275 consecutive patients with end-stage glenohumeral arthritis and Walch A- or B-type glenoid morphology who underwent primary aTSA in 2017-2018 at two high-volume shoulder arthroplasty institutions were evaluated, and patient-reported outcomes (PROMs) and radiographic findings were studied in those with completed baseline and minimum 2-year follow-up, respectively. Patient demographics, glenoid morphology, body mass index (BMI), Charlson Comorbidity Index (CCI), range of motion, American Shoulder and Elbow Surgeons (ASES) score, and Simple Assessment Numeric Evaluation score were collected. Radiographic analysis of glenoid and humeral components was performed. Multivariable logistic, equal adjacent odds ordinal, and beta regression were respectively used to identify predictors of glenoid radiolucent lines, humeral calcar resorption, and total ASES score. Patients were 43% female, with a mean age of 66, a median BMI of 30, and median follow-up of 28.4 months. ASES and Simple Assessment Numeric Evaluation scores improved by respective medians of 54.4 and 55.0 points, forward elevation by median 35°, and external rotation by median 30° (all P <.001 for preoperative to postoperative change). Postoperative radiographs of 177 cases showed 10 (5.7%) glenoid osteolysis, 51 (28.8%) glenoid radiolucent lines, and 81 (45.8%) calcar resorptions. The follow-up duration (median 40.1 vs. 27.2 months; P <.001), BMI (median 27.5 vs. 30.7; P <.001), and Charlson Comorbidity Index (Q3 0 vs. 1; P =.02) were associated with glenoid osteolysis in bivariate analyses. In multiple logistic regression, surgeon (C vs. A/B) was the only statistically significant predictor of glenoid radiolucent lines [OR 0.27, 95% CI (0.1, 0.8)]. By descending importance, Surgeon C [OR 6.5 (2.0, 20.5)], humeral canal filling ratio [upper vs. lower quartile OR 2.3 (1.3, 4.0)], mediolateral humeral head deviation [upper vs. lower quartile OR 1.9 (1.0, 3.5)], and glenoid osteolysis [OR 13.5 (2.6, 71.6)] significantly predicted greater calcar resorption. Longer follow-up duration marginally statistically significantly predicted lower ASES score [upper vs. lower quartile OR 0.8 (0.6, 1.0)]. Following aTSA with a peripherally enhanced fixation glenoid, pain, range of motion, and patient-reported outcomes significantly improved at a minimum of 2 years with only 5.7% glenoid osteolysis despite heterogeneous preoperative glenoid pathologies. [ABSTRACT FROM AUTHOR]

Total Knee Arthroplasty (TKA) is frequently performed for advanced osteoarthritis, with patient-reported outcome measures (PROMs) traditionally reporting on efficacy. These subjective evaluations, although useful, may inaccurately reflect post-TKA activity levels. With technological advancements, smart implantable devices (SIDs) offer objective, real-time gait metrics, potentially providing a more accurate postoperative recovery assessment. This study compares these objective metrics with PROMs to evaluate TKA success more effectively. We conducted a retrospective cohort study with 88 participants undergoing TKA using a SID. Eligible patients were aged 18 years or older and had advanced osteoarthritis. We excluded those who had bilateral TKAs, joint infections, or neuromuscular disease. The SID system collected daily gait metrics, including step count, distance traveled, walking speed, stride length, cadence, and functional knee range of motion. The PROMs, including Knee Injury and Osteoarthritis Outcome Score–Joint Replacement, Veterans Rand 12 Physical Component Summary, and Veterans Rand 12 Mental Component Summary, were analyzed against SID gait metrics. Among the 88 patients, 80 provided continuous data over 12 weeks. All gait metrics, except stride length, significantly increased at the 12-week point (P <.05). The PROMs also significantly improved postoperatively (P <.05). Initial low positive correlations between 12-week PROMs and SID metrics decreased after adjusting for demographic variables, leaving only weak correlations between the Veterans Rand 12 Physical Component Summary and Knee Injury and Osteoarthritis Outcome Score–Joint Replacement with functional knee range of motion (r = 0.389, P =.002; r = 0.311, P =.014, respectively), and Veterans Rand 12 Mental Component Summary with step count (r = 0.406, P =.001) and distance traveled (r = 0.376, P =.003). This study indicates that both PROMs and SID gait metrics show significant improvements post-TKA, though they correlate weakly with each other, suggesting a possible discrepancy between perceived recovery and actual functional improvement. The SID gait metrics might provide a valuable addition to traditional PROMs by offering an objective representation of physical capabilities unaffected by patient compliance or subjective perceptions of recovery. Further research is needed to validate these findings in larger populations and to explore whether integrating SID metrics can enhance long-term functional outcomes. [ABSTRACT FROM AUTHOR]

A heart-healthy diet is an important component of secondary prevention in ischemic heart disease. The Danish Health Authority recommends using the validated 19-item food frequency questionnaire HeartDiet in cardiac rehabilitation practice to assess patients' need for dietary interventions, and HeartDiet has been included in national electronic patient-reported outcome instruments for cardiac rehabilitation. This study aims to evaluate challenges and benefits of its use. The objectives are to: 1) describe HeartDiet responses of patients with ischemic heart disease and discuss HeartDiet's suitability as a screening tool, 2) discuss whether an abridged version should replace HeartDiet. A cross-sectional study using data from a national feasibility test. HeartDiet was sent electronically to 223 patients with ischemic heart disease prior to cardiac rehabilitation. Data were summarised with descriptive statistics, and Spearman's rank correlations, explorative factor analysis, and Cohen's kappa coefficient were used to derive and evaluate abridged versions. The response rate was 68 % (n = 151). Evaluated with HeartDiet, no respondents had a heart-healthy diet. There was substantial agreement between HeartDiet and an abridged 9-item version (kappa = 0.6926 for Fat Score, 0.6625 for FishFruitVegetable Score), but the abridged version omits information on milk products, wholegrain, nuts, and sugary snacks. With the predefined cut-offs, HeartDiet's suitability as a screening tool to assess needs for dietary interventions was limited, since no respondents were categorised as having a heart-healthy diet. An abridged version can replace HeartDiet, but the tool's educational potential will be compromised, since important items will be omitted. • A heart-healthy diet is important in secondary prevention in ischemic heart disease. • Patients should receive adequate support to obtain heart-healthy dietary habits. • HeartDiet food frequency questionnaire may aid referral for dietary interventions. [ABSTRACT FROM AUTHOR]

Lacking a nasal tip projection is a common deformity of Asian nasals. Various commonly used nasal tip grafts require dissecting septal perichondrium, most of them are autologous cartilage with a nonintegrated design. A snake-shaped expanded polytetrafluoroethylene (ePTFE) nasal tip graft is an integrated, stable tip graft without any additional assembly and splicing, conforming to the nasal anatomy characteristics of Asians. A retrospective study was performed on Asian patients who underwent rhinoplasty in the nasal tip at Peking University Third Hospital from 2015 to 2022. Nasal tip grafts were categorized into three groups: snake-shaped ePTFE combined with conchal cartilage (n = 15), only costal cartilage (n = 25), and only conchal cartilage (n = 17). Patients were excluded if their rhinoplasty did not involve any of the grafts above. Visual Analogue Scale, FACE-Q Nose, FACE-Q Nostril, Nasal Obstruction Symptom Evaluation scale, and Rhinoplasty Outcome Evaluation scale were used to evaluate the preoperative and postoperative results. Fifty-three (93.0%) cases had low nasal dorsum and 46 (80.7%) cases had short nose. There was no significant difference in complication rates among the three groups. The difference between preoperative and postoperative scale scores was statistically significant among the three groups (p < 0.05). Score improvements, including all scales, were the highest in the costal cartilage group and lowest in the conchal cartilage group. Snake-shaped ePTFE nasal tip grafts can be an effective integrated alternative that provides long-term safety and efficacy compared with traditional autogenous implants (conchal and costal cartilages). [ABSTRACT FROM AUTHOR]

Adult acquired buried penis (AABP) is a morbid condition often necessitating surgical intervention. Accurate assessment of pre- and postoperative symptoms is crucial to understand how AABP impacts a patients' quality of life, verify surgical effectiveness, and practice patient-centered care. There is no validated patient-reported outcome instrument specific for AABP evaluation. We undertook a comprehensive review of existing literature on patient-reported outcome instruments post-AABP surgery to highlight the importance of developing a specific tool. Following the preferred reporting items for systematic reviews and meta-analysis 2020 guidelines, we queried three databases using relevant keywords (e.g., "buried penis repair"). Inclusion criteria were studies that discussed surgical management of AABP with patient-reported outcomes. Pediatric and congenital cases were excluded. Information collected included study design, level of evidence, number of participants included in the study, etiology of buried penis, surgical technique, preoperative or postoperative patient-reported outcomes, and patient-reported outcome instrument used. Initial query identified 998 records. After abstract screening and applying the inclusion or exclusion criteria, a total of 19 articles with 440 patients were included. Eight studies implemented patient-reported outcome instruments. The international index of erectile dysfunction-5 and Likert satisfaction scales were used most frequently. Although all instruments were validated, none were validated in the specific context of AABP surgical intervention. There is considerable heterogeneity within the AABP literature regarding patient symptomatology, postoperative complications, patient-reported outcomes, and instruments used. The results of this study emphasize the need for a patient-reported outcome measure to examine the influence of AABP repair on patient satisfaction and health-related quality of life. [ABSTRACT FROM AUTHOR]

Background: The differentiation of specific, long-term health-related quality of life (HRQL) trajectories among esophageal cancer survivors remains unclear. The authors aimed to identify potentially distinctly different HRQL-trajectories and uncover the underlying factors of such trajectories in patients having undergone surgery (esophagectomy) for esophageal cancer. Materials and methods: This nationwide, prospective, and longitudinal cohort study included 420 patients who underwent curative treatment for esophageal cancer, including esophageal cancer surgery, in Sweden from 2001to 2005. The main outcome was HRQL summary score trajectories, measured by the well-validated EORTC QLQ-C30 questionnaire at 6 months, 3, 5, 10, and 15 years after esophagectomy, and analyzed using growth mixture models. Potentially underlying factors for these trajectories (age, sex, education, proxy baseline HRQL, comorbidity, tumor histology, chemo(radio)therapy, pathological tumor stage, and postoperative complications) were analyzed using weighted logistic regression providing odds ratios (OR) with 95% CI. Results: Four distinct HRQL summary score trajectories were identified: Persistently good, improving, deteriorating, and persistently poor. The odds of belonging to a persistently poor trajectory were decreased by longer education ( >12 years versus <9 years: OR 0.18, 95% CI: 0.05-0.66) and adenocarcinoma histology (adenocarcinoma versus squamous cell carcinoma: OR 0.37, 95% CI: 0.16-0.85), and increased by more advanced pathological tumor stage (III-IV versus 0-I: OR 2.82, 95% CI: 1.08-7.41) and postoperative complications (OR 2.94, 95% CI: 1.36-6.36). Conclusion: Distinct trajectories with persistently poor or deteriorating HRQL were identified after curative treatment for esophageal cancer. Education, tumor histology, pathological tumor stage, and postoperative complications might influence HRQL trajectories. The resultsmay contribute to amore tailored follow-up with timely and targeted interventions. Future research remains to confirm these findings. [ABSTRACT FROM AUTHOR]

Nonunion is a major complication of arthroscopic ankle arthrodesis. However, the characteristics and risk factors of nonunion are not well understood. This retrospective multicenter observational study aimed to clarify the characteristics of nonunion after arthroscopic ankle arthrodesis. We included 154 patients who underwent arthroscopic ankle arthrodesis at any 1 of 5 institutions. Patients were divided into 2 groups: union and nonunion, and the groups were compared. Age, sex, body mass index, diabetes, smoking, corticosteroid use, diagnosis, treatment information, treatment protocol, radiographic evaluation, and patient-reported outcomes were recorded and analyzed. On radiographs, bony union was observed in 142 ankles (91.0%) but not in 12 ankles (9.0%). Postoperative radiographic tibial bony gap (mm) was significantly larger in the nonunion group (medial = 1.98, center = 1.65, anterior = 2.21, middle = 1.72, posterior = 3.01) than in the union group (medial = 1.35, center = 1.13, anterior = 1.28, middle = 1.03, posterior = 2.03). Furthermore, the visual analog score (VAS) of pain and pain-related self-administered foot evaluation questionnaire (SAFE-Q) subscale score significantly worsened in the nonunion group (VAS = 3.83, SAFE-Q subscale score = 69.8) compared to that in the union group (VAS = 1.35, SAFE-Q subscale score = 76.6). A larger radiographic tibiotalar bony gap was observed in the nonunion group. Other measurement outcomes were not associated with nonunion. Additionally, patient-reported outcomes markedly worsened in the nonunion group. [ABSTRACT FROM AUTHOR]

Weight loss is commonly recommended before total knee arthroplasty (TKA) despite inconsistent evidence for better outcomes. This study sought to examine the impacts of preoperative weight loss on patient-reported and adverse outcomes among TKA patients supervised by a medical weight management clinic. This study retrospectively analyzed patients who underwent medical weight management supervision within 18 months before TKA comparing patients who did and did not have clinically relevant weight loss. Preoperative body mass indices, demographics, Patient-Reported Outcomes Measurement Information System physical function and pain interference scores, pain intensity scores, and adverse outcomes were extracted. Multivariable linear regressions were performed to determine if preoperative weight loss correlated with patient-reported outcomes after controlling for confounders. There were 90 patients, 75.6% women, who had a mean age of 65 years (range, 42-82) and were analyzed. There were 51 (56.7%) patients who underwent clinically relevant weight loss with a mean weight loss of 10.4% and experienced no difference in adverse outcomes. Preoperative weight loss predicted significantly improved 3-month postoperative physical function (β = 15.2 [13.0-17.3], P <.001), but not pain interference (β = −18.9 [-57.1-19.4], P =.215) or pain intensity (β = −1.8 [-4.9-1.2], P =.222) scores. We found that medically supervised preoperative weight loss predicted improvement in physical function 3 months after TKA. This weight loss caused no major adverse effects. Further research is needed to understand the causal relationships between preoperative weight loss, medical supervision, and outcome after TKA and to elucidate potential longer-term benefits in a larger sample. [ABSTRACT FROM AUTHOR]

The carpal tunnel syndrome instrument (CTSI) is the most widely used patient-reported outcome measure (PROM) in carpal tunnel syndrome (CTS). However, CTSI is an ordinal-type questionnaire and might have caused misinterpretations of the PROM between surgical outcomes of CTS (Camitz and extra/open carpal tunnel release). This study aims to convert the CTSI to an interval scale using Rasch analysis (RA) and evaluate the outcome differences between the original and transformed scales. Prospective control study. Four hundred twenty-four patients with 567 CTSs had been interviewed for CTSI perioperatively and treated with either endoscopic/open carpal tunnel release or Camitz tendon transfer. Each CTSI was analyzed for dimensionality, fit statistics, and a transformation of the ordinal-to-interval scale by RA. We compared the two groups perioperative scores of three CTSI versions (original 11-item, modified 8-item, and transformed 8-item). Based on the RA, the original CTSI was not unidimensional. We identified two dimensions. After removing misfit items, the perioperative course of each score by three versions of each dimension was compared (Repeated 2-factor analysis of variance). The transformed interval scales of CTSI provided different assessments of score changes from the ordinal scale of CTSI analyses. Original CTSI consisted of ordinal scale items that yielded different conclusions than scores converted to interval scale by Rasch analysis. CTSI should convert into an interval scale after reclassifying dimensionality by Latent Factor Analysis and removing misfit items • The original CTSI was not unidimensional. • Carpal tunnel syndrome instrument was transformed from an ordinal scale to interval scale. • The transformed interval scales of CTSI provided different assessments of score changes from the ordinal scale of CTSI analyses. • CTSI should convert into an interval scale after re-classifying dimensionality by Latent Factor Analysis and removing misfit items. [ABSTRACT FROM AUTHOR]

Purpose: We compared fluctuations in treatment response after onabotulinumtoxinA and sacral neuromodulation for urgency incontinence using Markov models. Materials and Methods: We fit data from a randomized trial to Markov models to compare transitions of success/failure over 6 months between 200 U onabotulinumtoxinA and sacral neuromodulation. Objective failure was <50% reduction in urgency incontinence episodes from baseline; subjective failure "strongly disagree" to "neutral" to the Patient Global Symptom Control questionnaire. Results: Of the 357 participants (median baseline daily urgency incontinence episodes 4.7 [IQR 3.7-6.0]) 61% vs 51% and 3.2% vs 6.1% reported persistent states of objective success and failure over 6 months after onabotulinumtoxinA vs sacral neuromodulation. Participants receiving onabotulinumtoxinA vs sacral neuromodulation had lower 30-day transition probabilities from objective and subjective success to failure (10% vs 14%, ratio 0.75 [95% CI 0.55-0.95]; 14% vs 21%, ratio 0.70 [95% CI 0.51-0.89]). The 30-day transition probability from objective and subjective failure to success did not differ between onabotulinumtoxinA and sacral neuromodulation (40% vs 36%, ratio 1.11 [95% CI 0.73-1.50]; 18% vs 17%, ratio 1.14 [95% CI 0.65-1.64]). Conclusions: Over 6 months after treatment, 2 in 5 women's symptoms fluctuate. Within these initial 6 months, women receiving onabotulinumtoxinA transitioned from success to failure over 30 days less often than sacral neuromodulation. For both treatments, there was an almost 20%-40% probability over 30 days that women returned to subjective and objective success after failure. Markov models add important information to longitudinal models on how symptoms fluctuate after urgency incontinence treatment. [ABSTRACT FROM AUTHOR]

Recently, open pose estimation using artificial intelligence (AI) has enabled the analysis of time series of human movements through digital video inputs. Analyzing a person's actual movement as a digitized image would give objectivity in evaluating a person's physical function. In the present study, we investigated the relationship of AI camera-based open pose estimation with Harris Hip Score (HHS) developed for patient-reported outcome (PRO) of hip joint function. HHS evaluation and pose estimation using AI camera were performed for a total of 56 patients after total hip arthroplasty in Gyeongsang National University Hospital. Joint angles and gait parameters were analyzed by extracting joint points from time-series data of the patient's movements. A total of 65 parameters were from raw data of the lower extremity. Principal component analysis (PCA) was used to find main parameters. K-means cluster, X-squared test, Random forest, and mean decrease Gini (MDG) graph were also applied. The train model showed 75% prediction accuracy and the test model showed 81.8% reality prediction accuracy in Random forest. "Anklerang_max", "kneeankle_diff", and "anklerang_rl" showed the top 3 Gini importance score in the Mean Decrease Gini (MDG) graph. The present study shows that pose estimation data using AI camera is related to HHS by presenting associated gait parameters. In addition, our results suggest that ankle angle associated parameters could be key factors of gait analysis in patients who undergo total hip arthroplasty. [ABSTRACT FROM AUTHOR]

Despite advancements in the surgical techniques of rotator cuff repair (RCR), there remains a high retear rate. Biological augmentation of repairs with overlaying grafts and scaffolds may enhance healing and strengthen the repair construct. This study aimed to investigate the efficacy and safety of scaffold-based (nonstructural) and overlay graft–based (structural) biological augmentation in RCR (excluding superior capsule reconstruction and bridging techniques) in both preclinical and clinical studies. This systematic review was performed in adherence to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines, as well as guidelines outlined by The Cochrane Collaboration. A search of the PubMed, Embase, and Cochrane Library databases from 2010 until 2022 was conducted to identify studies reporting the clinical, functional, and/or patient-reported outcomes of ≥1 biological augmentation method in either animal models or humans. The methodologic quality of included primary studies was appraised using the Checklist to Evaluate a Report of a Non-pharmacological Trial (CLEAR-NPT) for randomized controlled trials and using the Methodological Index for Non-randomized Studies (MINORS) for nonrandomized studies. A total of 62 studies (Level I-IV evidence) were included, comprising 47 studies reporting outcomes in animal models and 15 clinical studies. Of the 47 animal-model studies, 41 (87.2%) demonstrated biomechanical and histologic enhancement with improved RCR load to failure, stiffness, and strength. Of the 15 clinical studies, 10 (66.7%) illustrated improvement in postoperative clinical, functional, and patient-reported outcomes (eg, retear rate, radiographic thickness and footprint, and patient functional scores). No study reported a significant detriment to repair with augmentation, and all studies endorsed low complication rates. A meta-analysis of pooled retear rates demonstrated significantly lower odds of retear after treatment with biological augmentation of RCR compared with treatment with non-augmented RCR (odds ratio, 0.28; P <.00001), with low heterogeneity (I 2 = 0.11). Graft and scaffold augmentations have shown favorable results in both preclinical and clinical studies. Of the investigated clinical grafts and scaffolds, acellular human dermal allograft and bovine collagen demonstrate the most promising preliminary evidence in the graft and scaffold categories, respectively. With a low risk of bias, meta-analysis revealed that biological augmentation significantly lowered the odds of retear. Although further investigation is warranted, these findings suggest graft and scaffold biological augmentation of RCR to be safe [ABSTRACT FROM AUTHOR]

Background Patients report psychological barriers as important when returning to sport, however, psychological outcome measures are seldom included in return to sport (RTS) assessment. There is a need for clinical trials to integrate psychological patient-reported outcomes (PROs) in return to sport batteries assessing patients treated with ACL reconstruction. Objective The aim of this study was to determine the association between passing clinical tests of muscle function and psychological PROs and sustaining a second ACL injury in patients who RTS after primary ACL reconstruction. Design Retrospective Cohort study Methods Patients' sex, age, height and weight, and the results of strength and hop tests, as well as answers to PRO's (including Tegner activity scale, the ACL Return to Sport after Injury scale (ACL-RSI) as well as the Quality of Life (QoL) subscale of the Knee injury and Osteoarthritis Outcome Score [KOOS]), were extracted from a rehabilitation-specific registry. Four different test batteries comprising muscle function tests and PROs were created to assess whether patients were ready to RTS. Passing each of the test batteries (yes/no) was used as an independent variable. A multivariable Cox proportional hazard model analysis was performed, with sustaining a second ACL injury (either ipsi- or contralateral; yes/no) within two years of RTS as the dependent variable. Results A total of 419 patients (male, n=214; 51%) were included, of which 51 (12.2%) suffered a second ACL injury within the first two years after RTS. There were no differences in passing rates in the different RTS test batteries comprising muscle function tests and PROs for patients who suffered a second ACL injury compared to patients who did not. Conclusion No association between passing the RTS clinical tests batteries comprising muscle function and psychological PROs used, and the risk of a second ACL injury could be found. Level of Evidence 3 [ABSTRACT FROM AUTHOR]

Limited data exist on the impact of radiographic measurements in patient-reported outcomes after anatomic total shoulder arthroplasty (aTSA). The aim of this study was to investigate the association between outcomes following aTSA and the patient's preoperative and postoperative radiographic parameters, including the greater tuberosity angle (GTA), the acromiohumeral center edge angle (ACEA), and the critical shoulder angle (CSA). This retrospective study involves patients who underwent primary aTSA with a minimum 2-year follow-up. Patients were identified through data stored in a prospectively collected database at our institution. Patients completed American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) scores preoperatively and at 2-year follow-up. Before and after surgery, all radiographic parameters were also assessed by 2 independent reviewers using radiographs. Data were analyzed as continuous measurements and in groupings based on radiographic parameters (67° for GTA, 18° for ACEA, and 30° for CSA measurement). Correlations between significant parameters and clinical outcomes were calculated using the Pearson correlation coefficient. Significance was defined as P <.05. A total of 86 patients were included. Preoperatively, the GTA measurement (67.3° ± 4.7°) was significantly more than postoperative (62.5° ± 6.3°, P <.001). The higher preoperative GTA group (GTA ≥ 67°) had a significantly better postoperative ASES score, 92.1 ± 8.9, compared to the lower group (GTA < 67°), 81.7 ± 16.2, P <.001. Furthermore, a positive significant correlation existed between preoperative GTA values and postoperative ASES scores (r = 0.32, P =.003) with better outcomes associated with higher preoperative GTA values. No difference existed in the postoperative patient-reported outcomes based on postoperative GTA, preoperative and postoperative ACEA, and CSA parameters. Our study identified a significant association at short-term follow-up between preoperative GTA measurements and clinical outcomes in patients who underwent aTSA. Consequently, GTA values may be helpful when making preoperative assessments and discussing postoperative outcome following aTSA. [ABSTRACT FROM AUTHOR]

To investigate the association between sex, self-reported ankle function, pain intensity, kinesiophobia, and perceived ankle instability in athletes with chronic ankle instability (CAI). Cross-Sectional Study. University. College club sports athletes with CAI (n = 42). Relationships with the Cumberland Ankle Instability Tool (CAIT) score and the Tampa Scale for Kinesiophobia-11 (TSK-11), the Foot and Ankle Ability Measure (FAAM), sex (0: male, 1: female), and ankle pain intensity by the Numeric Rating Scale were explored with multiple regression analysis. The regression model explained 50.3% of the variance of the CAIT score (P < 0.001), and the TSK-11 score (B = −0.382, P = 0.002), the FAAM sports subscale score (B = 0.122, P = 0.038), and sex (B = −2.646, P = 0.031) were significant independent variables for the CAIT score (P < 0.001), while pain intensity was not significant (B = −0.182, P = 0.504). These results indicated that higher TSK-11 score, lower FAAM sports subscale score, and being female were related to lower CAIT score. Kinesiophobia related to perceived instability along with self-reported function and sex in athletes with CAI. Clinicians should assess the psychological aspects of athletes with CAI. • A higher TSK-11 score was significantly associated with a lower CAIT score. • A lower FAAM score was significantly associated with a lower CAIT score. • Being female decreased the CAIT score by 2.6 points in athletes with CAI. • Ankle pain intensity was not a significant variable for the CAIT score. • Clinicians should focus on the psychological aspects of athletes with CAI. [ABSTRACT FROM AUTHOR]

Treating massive and irreparable rotator cuff tears are problematic. Several studies have reported that polytetrafluoroethylene (PTFE) patches demonstrated excellent construct integrity and positive clinical and patient outcomes. However, these studies either had small sample sizes or short follow-up periods. To determine the survivorship, efficacy, and medium-term (2-19 years) outcomes of PTFE patch repairs. This retrospective study used prospectively collected data to establish the medium-term outcomes of PTFE interposition patch repairs for massive rotator cuff tears that could not be repaired by the standard technique. Patients included those who met the ≥2-year follow-up criteria post repair. Standardized assessments of patient-ranked shoulder pain and function and shoulder strength and passive range of motion (ROM) were performed preoperatively and at follow-up visits. Radiographs and ultrasonography were used to evaluate repair integrity, measure proximal humeral head migration, and determine glenohumeral arthritis scores. Forty-one shoulders formed the study cohort at a mean follow-up period of 5 years (range: 2-19 years). The mean age of this group was 72 (standard deviation: 10; range: 50-88) and had 14 cm2 tears at surgery. Twenty-five of 41 (61%) PTFE interposition patch repairs remained intact at an average of 5 years postrepair. Thirteen patches failed at the patch-tendon junction, 1 was removed, and 2 patients underwent reverse total shoulder replacement. Patient-ranked shoulder stiffness (P <.05), frequency of pain during activity and sleep (P <.001), pain levels during overhead activity and rest (P <.001), and overall shoulder function significantly improved from bad preoperatively to fair at the mean 5-year postoperative visit (P <.001). No significant improvements were demonstrated in dynamometer-measured shoulder strength maneuvers and passive ROM. All patients demonstrated proximal humeral head migration on shoulder radiographs regardless of repair integrity (mean Upper Migration Index = 1.2). Failed repairs were associated with higher mean preoperative glenohumeral arthritis grades compared with intact repairs (grade 2 in failed repairs compared with grade 1 in intact repairs) (P <.01). PTFE interposition patch repairs for massive and irreparable tears had good construct integrity and clinical outcomes at 2 years. These outcomes were not maintained. PTFE patch repairs often failed at the patch-tendon junction at 4 years and beyond and were ineffective in (1) preventing proximal humeral head migration, (2) stopping progression of glenohumeral arthritis, and (3) improving shoulder strength and ROM. [ABSTRACT FROM AUTHOR]

The Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) and PROMIS Physical Function (PF) are increasingly referenced patient-reported outcomes. To interpret treatment effects with these patient-reported outcomes, investigators must understand magnitudes of change that represent clinically relevant improvement. This study assessed the responsiveness of PROMIS UE and PF in patients with cubital tunnel syndrome. A retrospective analysis of PROMIS UE and PROMIS PF computer adaptive test scores was performed for patients treated nonoperatively for cubital tunnel syndrome over 3 years at a tertiary institution. The Patient-Reported Outcomes Measurement Information System UE and PROMIS PF outcome scores were collected at initial and return clinic visits. At follow-up appointments, patients completed clinical anchor questions evaluating their degree of interval clinical improvement. Anchor questions allowed categorization of patients into groups that had experienced "no change," "minimal change," and "much change." Minimal clinically important difference (MCID) values were calculated for the PROMIS assessments with anchor-based and distribution-based methods. A total of 304 patients with PROMIS PF scores and 111 with PROMIS UE scores were analyzed. The MCID for the PROMIS UE was 3.1 (95% confidence interval, 1.4–4.8) using the anchor-based method and 3.7 (95% confidence interval, 2.9–4.4) using the distribution-based method. These point estimates exceeded the minimal detectable change of 2.3. The MCID for the PROMIS PF was unable to be determined in this patient sample because patients reporting mild change did not have score changes exceeding measurement error. The PROMIS UE v2.0 computer adaptive test detected minimal change in patients managed nonoperatively for cubital tunnel syndrome with an estimated MCID range of 3.1–3.7. While PROMIS PF has demonstrated acceptable performance in patients with a variety of upper extremity conditions, for cubital tunnel syndrome, it was less able to detect subtle change. PROMIS UE appears more responsive to subtle changes in cubital tunnel syndrome symptoms. Patient-reported outcomes may have varied responsiveness depending on the condition studied. [ABSTRACT FROM AUTHOR]

Background: Sesamoid position change after distal chevron osteotomy for moderate to severe hallux valgus is not well known in the literature. The objective of this study was to determine whether the sesamoid position changed over 2 years after distal chevron osteotomy for moderate to severe hallux valgus. Methods: Ninety-seven patients who underwent distal chevron osteotomy for moderate to severe hallux valgus were prospectively assessed for 2 years. There were 91 females, and the mean age was 54.9 (SD 10.9) years. The Self-Reported Foot and Ankle Score (SEFAS) was used for functional assessment. Foot pain was assessed by a 0-10 visual analog scale (VAS), and patient satisfaction by a 5-point Likert scale. Radiologically, hallux valgus angle (HVA), first-second intermetatarsal angle (IMA), distal metatarsal articular angle (DMAA), metatarsal head displacement, and sesamoid position by the AOFAS criteria were analyzed. Patients were classified according to the medial sesamoid position on the first postoperative weightbearing radiograph (1º-WB-Xray) into the reduced sesamoid group (66 patients) and nonreduced sesamoid group (31 patients). Results: All patients were assessed preoperatively and postoperatively at 1 month and 2 years. On the 1º-WB-Xray, IMA was significantly lower in the reduced group (P =.038), but HVA (P =.063) and DMAA (P =.246) were not significantly different. At the final follow-up, no patients in the reduced group had sesamoid position change from 1º-WB-Xray, whereas 8 (25.8%) patients in the nonreduced group had change of their sesamoid positions. The SEFAS was not significantly different between groups preoperatively (P =.386) or at 1 month postoperation (P =.064). The final SEFAS, VAS pain, and satisfaction scores were significantly better in the reduced group, although the clinical significance of these changes remains unknown. Conclusion: A nonreduced position of the sesamoids obtained in surgery can cause their increased malposition over 2 postoperative years and statistically less functional outcomes. Level of Evidence: Level II, prospective cohort study. [ABSTRACT FROM AUTHOR]

• Significant but weak correlation exists between maternal satisfaction and quality of recovery after caesarean delivery. • Spinal anaesthesia and scheduled caesarean deliveries are associated with greater satisfaction for a given quality of recovery score. • Quality of communication and interactions with staff are significant drivers of patient satisfaction. • Postpartum physical environment has a significant influence on patient satisfaction levels. Patient satisfaction and quality of recovery (QoR) are important patient-reported outcomes and quality metrics. The relationship between these two outcomes is complex, with studies showing a weak correlation between them in the non-obstetric population. We sought to evaluate the correlation between patient satisfaction and QoR scores in the obstetric population after caesarean delivery. As secondary aims, we aimed to determine the influence of urgency of procedure and mode of anaesthetic on patient satisfaction and QoR scores as well as determining drivers of satisfaction and dissatisfaction. Women were invited to complete the Maternal Satisfaction Scale for Caesarean Section (MSCS) and Obstetric Quality of Recovery Score (ObsQoR-11) questionnaires at 24 h after caesarean delivery. Correlations were analysed using Spearman's rank tests. Qualitative data were analyzed using thematic content analysis. Data were collected from 300 women. There was a significant but weak positive correlation between ObsQoR-11 and MSCS scores (r = 0.31, P < 0.001). Correlation was significantly influenced by mode of anaesthesia (P < 0.001) and urgency of procedure (P = 0.005), with greater satisfaction amongst patients receiving spinal anaesthesia and those undergoing scheduled caesarean deliveries for a given QoR score. Quality of communication, interactions with staff and aspects of the postpartum physical environment were significant determinants of satisfaction and dissatisfaction. Maternal satisfaction and obstetric QoR are distinct entities with a weak correlation between the two variables. Urgency of procedure and mode of anaesthesia are significant predictors of the correlation between satisfaction and quality of recovery scores. Many of the drivers of satisfaction were modifiable including quality of communication and a comfortable physical space for postpartum recovery. [ABSTRACT FROM AUTHOR]

• PROMIS Pain Interference 6a has strong construct validity in myositis. • PROMIS Fatigue 7a demonstrates strong construct validity in myositis. • PROMIS Physical Function 8b has strong construct validity in myositis. • Construct validity for these PROMIS measures is similar across myositis subtypes. Validated patient-reported outcome measures to assess disease impact in patients with adult idiopathic inflammatory myopathies (IIMs) are needed. The objective of this study was to assess the construct validity of PROMIS Pain Interference, Fatigue, and Physical Function measures in comparison with core disease activity measures. Adults with IIM, excluding inclusion body myositis, from OMERACT Myositis Working Group (MWG) clinic sites completed PROMIS Short Form v1.0—Pain Interference 6a, PROMIS Short Form v1.0—Fatigue 7a, and PROMIS Short Form v2.0—Physical Function 8b measures. Core disease activity measures including patient and physician global disease activity assessments, manual muscle testing, serum creatine kinase activity, and Health Assessment Questionnaire Disability Index (HAQ-DI) were simultaneously assessed. To evaluate construct validity, a priori hypotheses for the expected correlations between PROMIS measures, age, and core disease measures were determined by >70 % agreement among MWG members and were compared against observed Pearson's correlations. Internal consistency of items and floor or ceiling effects for the PROMIS measures were also assessed. Subgroup analysis according to IIM subtype (dermatomyositis vs. non-dermatomyositis IIM) was performed. 135 adults with IIM from 5 countries across North America, Europe, Asia, and Australia were included. For construct validity, a priori hypotheses were confirmed for 5 of 6 (83 %) PROMIS Pain Interference, 4 of 5 (80 %) PROMIS Fatigue, and 3 of 4 (75 %) PROMIS Physical Function correlations. Internal consistency was high for each PROMIS measure (Cronbach's alpha >0.9). Ceiling effects were observed only for PROMIS Pain Interference, with low/no pain in 29 % of patients. Subgroup analysis between dermatomyositis (n = 65) and non-dermatomyositis (n = 70) subtypes demonstrated similar correlations between PROMIS measures and disease activity measures. PROMIS Short Form v1.0—Pain Interference 6a, PROMIS Short Form v1.0—Fatigue 7a, and PROMIS Short Form v2.0—Physical Function 8b measures demonstrate strong construct validity when compared to core disease activity measures in IIM, with consistent results across IIM subtypes. These findings support the use of these selected PROMIS measures to assess core domains of interest for measuring life impact in IIMs. [ABSTRACT FROM AUTHOR]

Patients with lower leg chronic exertional compartment syndrome are impaired due to exercise-related pain. Fasciotomy is the surgical gold standard. However, it is unknown whether number of simultaneously opened compartments affects outcome. The purpose of this systematic review was to compare patient-reported outcomes of a 2-compartment fasciotomy with a 4-compartment fasciotomy. Controlled clinical trials (randomized/nonrandomized), cohort studies and case series reporting on outcome following either 2-compartment or 4-compartment fasciotomy for lower leg chronic exertional compartment syndrome were searched until May 31, 2021 in PubMed, EMBASE, and Cochrane. Results were qualitatively synthesized. Risk of bias and levels of evidence were determined. Seven studies reporting on altogether 194 athletes and military personnel (mean age 24 y) were included. Quality assessment revealed a high risk of bias in all studies. Both 2-compartment and 4-compartment fasciotomy were associated with a 50% to 100% "return to activity" rate (in studies reporting group results separately: 2-compartment 90%-100%; 4-compartment 50%-100%) and a 41% to 100% "return to previous activity" rate (in studies reporting group results separately: 2-compartment 82-100%; 4-compartment 50%-100%) without significant differences. Mean Marx activity score of 1 study found a small significant standardized mean difference (0.196 [0.524,0.916]) favoring 4-compartment fasciotomy. Rate of satisfaction (2-compartment 74%-89%; 4-compartment 75%-100%) and residual symptoms (2-compartment 0%-36%; 4-compartment 0%-50%) indicated no group differences. In conclusion, a 2-compartment fasciotomy or a 4-compartment fasciotomy for lower leg chronic exertional compartment syndrome appears to be equally successful. However, included studies were hampered by methodological shortcomings (low sample size, selection bias, heterogeneity and no uniform outcome measures). [ABSTRACT FROM AUTHOR]

Background: Multiple authors have sought to determine what patient characteristics influence outcome after total hip arthroplasty (THA). Age has shown no effect on outcome in some evaluations, while others have reported higher functional improvement in younger patients. The aim of this study was to determine if outcome after THA varies based on patient age.Methods: A prospective, multicenter cohort of 7,934 unilateral primary THA patients from the FORCE-TJR comparative effectiveness consortium was evaluated. Demographic data, comorbid conditions, and Patient-Reported Outcome Measures, including (HOOS), HOOS-12, HOOS JR, and SF-36 (PCS) and (MCS), were collected preop and at 1-year postop. Descriptive statistics were generated, stratified by age (<55 years [younger adult], 55-64 years [older adult], 65-74 years [early elder], and ≥75 years [late elder]), and differences in pain, function, and quality of life among the 4 age groups were evaluated. A multivariate regression model with 95% confidence interval (CI) was used to assess the role of patient age as a predictive factor for HOOS pain and function scores reported 1 year after primary THA.Results: Prior to surgery, younger patients (<55 years) reported worse pain, function, and quality of life than the other 3 patient groups. At 1 year after THA, younger patients (<55 years) reported slightly worse pain and quality of life but better function scores than the 3 older patients' groups. Younger patients (<55 years) achieved higher baseline to 1-year pain, and function score changes when compared to the older patients' groups. The quality of life score changes was not different among the 4 age groups. The differences in 1-year postop scores (ranging from 2.74 to 8.46) and the magnitude of score changes from baseline to 1 year (ranging from 1.9 to 5.85), although statistically significant (P < .001), did not reach the minimal clinically important difference (MCID). The multivariate regression analysis shows that age is a significant predictor for pain at 1 year but not for function. Although HOOS pain score is predicted to be higher by 4.38 points (less pain) 1 year after THA in older patients (≥75), when compared to younger patients (<55 years), again the difference is well below the MCID and is clinically insignificant.Conclusion: Although there are statistically significant differences in pain relief, functional improvement, and quality of life between younger and older patients among different patients' age groups, there is no clinically significant difference. THA provides an improvement in quality of life by decreasing pain and increasing function in all 4 age groups, with large improvements in Patient-Reported Outcome Measures scores (>2 standard deviations) without clinically significant age-related differences in THA outcome at 1 year. [ABSTRACT FROM AUTHOR]

There has been an increasing emphasis on placing patients at the center of clinical care and health care research and, in particular, assessing outcomes and experiences from the patient's perspective. One of the most widely used patient-reported outcome instruments is the Veterans RAND 12-item Health Survey (VR-12). This article reviews the VR-12 development and its applications over the last 2 decades, including research and potential uses in clinical care. [ABSTRACT FROM AUTHOR]

Background: Catheter ablation is widely used as first-line therapy for patients with impaired quality of life; however, whether catheter ablation improves survival and other outcomes in atrial fibrillation (AF) cases remains unclear.Objective: The purpose of this study was to evaluate whether catheter ablation reduces adverse clinical outcomes and improves patients' quality of life using data from a contemporary Japanese multicenter registry of patients with early-stage AF.Methods: The Keio Interhospital Cardiovascular Studies-Atrial Fibrillation registered 3318 patients with AF newly diagnosed at or referred to participating hospitals between 2014 and 2018. Propensity score matching based on 47 demographic variables was performed. We extracted 823 pairs who underwent catheter ablation or medical therapy alone. The primary outcome was the composite of all-cause death, stroke, bleeding events, and heart failure hospitalization during a 2-year follow-up period. Additionally, the Atrial Fibrillation Effect on QualiΤy-of-Life scores at baseline and 1-year follow-up were evaluated.Results: Within the matched cohort, the median time since AF diagnosis was 0.3 years (interquartile range [IQR] 0.1‒2.3 years), age was 67.0 years (IQR 59.0‒73.0 years), and the CHA2DS2-VASc score was 2.0 (IQR 1.0‒2.0). During a median follow-up period of 730 days (IQR 366‒731 days), patients who underwent catheter ablation had a lower risk of primary outcomes (hazard ratio 0.49; 95% confidence interval 0.30‒0.79; P = .004), with a significantly lower risk of heart failure hospitalization (hazard ratio 0.33; 95% confidence interval 0.14-0.77; P = .010) and improved Atrial Fibrillation Effect on QualiΤy-of-Life scores, than did those who received medical therapy.Conclusion: In patients with propensity score-matched, early-stage, real-world AF, catheter ablation was associated with a lower risk of adverse clinical events and improved quality of life as compared with medical therapy. [ABSTRACT FROM AUTHOR]

Background: The aim of this study is to assess the association between a spinopelvic malalignment and patient-reported perception of the hip as being "artificial" after total hip arthroplasty (THA). This is a critical issue as an age-related spinopelvic mismatch has been postulated to be associated with the risk of poor outcomes after THA.Methods: This is a retrospective case-control study of 274 THAs (244 of whom were women), with a mean follow-up of 6.2 (range 5.0-8.2) years. Hip perception was assessed by asking subjects whether their joint felt "natural" or "artificial." The association between an artificial perception and the following factors was evaluated: age, gender, psoas muscle index (PMI, cross-sectional area of bilateral psoas at L3 divided by height squared), and spinopelvic measures using logistic regression analysis.Results: An artificial hip perception (130 hips, 47.4%) was associated with a lower PMI (P = .016), Hip Disability and Osteoarthritis Outcome Score Joint Replacement score (P = .035), EuroQol 5-Dimension score (P = .041), and a higher incidence of a pelvic incidence-minus-lumbar lordosis (PI-LL) mismatch >10° (P < .001). A flatback deformity (odds ratio 2.24, 95% confidence interval 1.22-6.31, P = .001) and PMI (odds ratio 0.61, 95% confidence interval 0.34-0.82, P = .012) were predictive of an artificial perception. With the threshold of PI-LL set to 10°, PMI (P = .034), Hip Disability and Osteoarthritis Outcome Score Joint Replacement score (P < .001), joint perception (P = .020), EuroQol 5-Dimension score (P = .028), pain (P = .031), and satisfaction (P < .001) differed between the 2 groups.Conclusion: A flatback deformity is associated with the risk of an artificial perception post-THA, especially in patients with sarcopenia. PMI and PI-LL measurements may help predict THA outcomes. [ABSTRACT FROM AUTHOR]

Measurement of the outcome following shoulder surgery often demonstrates the discrepancy between the surgeon's perceptions and those of the patient. Therefore, it has been recognized that it is no longer acceptable to present purely surgeon-reported outcomes for shoulder surgery. As the number of shoulder procedures performed worldwide has increased in recent years, so has the necessity to measure performance. A combination of patient-reported outcome measures (PROMs), surgeon-reported outcomes and, for arthroplasty, national registry data is now commonly presented to quantify any change following intervention for a symptomatic shoulder joint. However, as the shoulder is a complex entity itself, involving a number of joints and possible pathologies, it can be difficult to comprehend whether a certain measure is being used appropriately. The aim of this article is to highlight the most frequently used outcome scores, including PROMs and national shoulder registries, discussing what they aim to measure, their strengths, limitations, specificity to pathology or procedure and cautions for bias. [ABSTRACT FROM AUTHOR]

Optimal surgical recovery is critical to readiness to return to intended oncologic therapy (RIOT). The current study defined the value of patient-reported outcomes (PROs) in predicting the risk for delayed RIOT after oncologic hepatic resection. In a prospective longitudinal study, perioperative symptoms were assessed using a valid PRO assessment tool, the MD Anderson Symptom Inventory module for hepatectomy perioperative care (MDASI-PeriOp-Hep), for 4 weeks after surgery. The timed up and go test (TUGT) was administered before surgery, by discharge day, and at the first postoperative follow-up visit. Multivariate logistic regression analysis assessed the predictive value of PROs for delayed RIOT. We enrolled 210 patients and analyzed 148 patients who received adjuvant chemotherapy and contributed more than 3 PRO assessments postoperatively. About 36 percent of the patients had delayed RIOT (>5 weeks, range 1–14 weeks). MDASI scores for drowsiness, fatigue, dry mouth, and interference with general activity, walking, and work on day 7 after discharge and MDASI scores for incisional tightness, fatigue, dry mouth, shortness of breath, and interference with work on day 14 after discharge were associated with delayed RIOT (all P < 0.05). Walking and general activity items on the MDASI-Interference subscale on day 7 after discharge were highly correlated with prolonged TUGT scores at discharge (P < 0.01). We defined clinically meaningful PROs on MDASI-PeriOp-Hep after hepatic resection that predicted increased risk of delayed RIOT. These findings highlight the importance PROs for monitoring symptoms and functioning 1–2 weeks after discharge to be implementing into perioperative care. • We track patient-reported symptoms after oncologic hepatic resection. • PROs could predict the risk for delayed RIOT after oncologic hepatic resection. • The results support monitoring of PROs after oncologic hepatic resection. [ABSTRACT FROM AUTHOR]

Background: The purpose of this study is to analyze the potential influence of subclinical hypothyroidism (SCH) on improvement in patient-reported outcome measures following primary total knee arthroplasty.Methods: A prospective, comparative cohort study between 92 SCH and 90 euthyroid patients was performed. Patients were followed up to 5 postoperative years. Patient-reported outcome measure was assessed by the Western Ontario and McMaster Universities Osteoarthritis Index questionnaire. The Knee Society Scores were used for functional evaluation, and 5-point Likert scale for patient satisfaction. The Hospital Anxiety and Depression scale was also used.Results: All outcome scores significantly improved from preoperative to final follow-up in both groups (P = .001). There were no significant differences between groups in Knee Society Scores (P = .057) at the final follow-up, but Western Ontario and McMaster Universities Osteoarthritis Index scores were significantly lower in the SCH group (P = .015). Likewise, the patient satisfaction rate was significant lower in the SCH group (0.010).Conclusion: SCH patients have a slower functional recovery than euthyroid patients, and trended toward lower improvements in patient-reported scores. Depression was the most important negative factor. The findings of this study can provide the surgeon with an important information for better counseling the SCH patients. [ABSTRACT FROM AUTHOR]

Objective: Ability to assess flares in osteoarthritis (OA) of the knee and hip (KHOA) is important in clinical care and research. Using mixed methods, we developed a self-reported instrument measuring flare and assessed its psychometric properties.Methods: We constructed questionnaire items from semi-structured interviews and a focus group (patients, clinicians) by using a dual-language (English-French) approach. A Delphi consensus method was used to select the most relevant items. Patients with OA from Australia, France and the United States completed the preliminary Flare-OA, HOOS, KOOS and Mini-OAKHQOL questionnaires online. We used a factor analysis and content approach to reduce items and determine structural validity. We tested the resulting questionnaire (score 0-100) for internal consistency, convergent and known-groups validity.Results: Initially, 180 statements were generated and reduced to 33 items in five domains (response 0 = not at all, to 10 = absolutely) by Delphi consensus (50 patients, 116 professionals) and an expert meeting. After 398 patients (mean [SD] age 64 [8.5] years, 70.4% female, 86.7% knee OA) completed the questionnaire, it was reduced to 19 items by factor analysis and a content approach (RMSEA = 0.06; CFI = 0.96; TLI = 0.94). The Cronbach's alpha was >0.9 for the five domains and the whole questionnaire. Correlation coefficients between Flare-OA and other instrument scores were as predicted, supporting construct validity. The difference in Flare-OA score between patients with and without flare (31.8) largely exceeded 2 SEM (10.2).Conclusion: Flare-OA is a valid and reliable patient-reported instrument for assessing the occurrence and severity of flare in patients with KHOA in clinical research. [ABSTRACT FROM AUTHOR]

*OBJECTIVE: To investigate return to sport (RTS) approximately 5 years after arthroscopic partial meniscectomy (APM). * DESIGN: Retrospective cohort study. *METHODS: Knee Arthroscopy Cohort Southern Denmark patients were asked about RTS and reasons for non-RTS approximately 5 years (range, 4-6 years) after APM using online questionnaires. Patients engaged in their sport at the pre-injury level at follow-up were classified as "RTS" (or "returned to sport") and as being engaged in their sport with (1) full participation and performance, (2) reduced performance, or (3) both reduced participation and performance. Self-reported knee function was assessed using the Knee injury and Osteoarthritis Outcome Score (KOOS). * RESULTS: We included 288 patients (mean ± SD age, 49 ± 12 years; 44% women). Of these, 172 patients (60%; 95% confidence interval, 54%-65%) were classified as returned to sport, but only 42% (72/172) reported full participation and performance. Persistent problems with the operated knee were reported by 60% of the patients as the main reason for reduced participation or performance and by 70% of the patients as the main reason for not returning to pre-injury levels of their sport. Patients who had returned to sport, on average, improved by 10.1 points (95% confidence interval, 5.7-14.4) more in KOOS4 scores from baseline to 5 years than non-RTS patients. * CONCLUSION: At approximately 5 years after APM, 6 in every 10 patients had returned to their sport at pre-injury levels, but only 1 in every 4 returned with full participation and performance, mainly due to persistent knee problems. Greater improvements in KOOS scores were observed in patients who were classified as returned to sport. [ABSTRACT FROM AUTHOR]

We investigated the clinical outcomes of surgical procedures for the treatment of forefoot deformities in patients with rheumatoid arthritis. Twenty feet in 16 women (mean age 62.1 years) underwent corrective osteotomy of the first metatarsal bone with shortening oblique osteotomy of the lesser metatarsophalangeal joints (joint-preservation group), while 13 feet in 12 women (mean age 67.4 years) underwent arthrodesis of the first metatarsophalangeal joint with resection arthroplasty of the lesser metatarsophalangeal joints (joint-sacrifice group); mean follow-up for each group was 25.8 and 23.8 months, respectively. The mean total Japanese Society for Surgery of the Foot (JSSF) scale improved significantly from 64.2 to 89.2 in the joint-preservation group (p <.001), and from 54.2 to 74.2 in the joint-sacrifice group (p =.003). In the joint-preservation group, the postoperative range of motion (ROM) of the joint, walking ability, and activities of daily living scores of the JSSF scale were significantly higher than those in the joint-sacrifice group (p =.001, p =.001, and p =.019, respectively). There were no differences in the subscale scores of the self-administered foot evaluation questionnaire between 2 groups either pre- or postoperatively. No differences in the postoperative complications were found between 2 groups. Although the joint-sacrificing procedure resulted in lower objective outcomes than the joint-preserving procedure regarding the ROM of the joint, the walking ability, and the level of activities of daily living, both procedures resulted in similar treatment outcomes when evaluated by the subjective measures. [ABSTRACT FROM AUTHOR]

The University of Wisconsin Running Injury and Recovery Index (UWRI) was developed as an evaluative patient-reported outcome measure of perceived running ability and recovery after running-related injuries. To date, the questionnaire was not translated into German language and studies on its clinical feasibility and validity are sparse. Prospective cohort study. Outpatient sports medicine clinic. The UWRI questionnaire was translated to German language using a state-of-the art back-translation method including three translators and two back-translators. Clinical feasibility and validation were assessed in 14 injured runners. UWRI total score, running volume. The translation process was completed without major discrepancies. Feasibility and preliminary evaluation were demonstrated in a cohort of 14 injured runners. The UWRI total score significantly improved throughout 12 weeks of recovering from running-related injuries (p < 0.001). Relative running volume significantly correlated with UWRI score (p < 0.001). The University of Wisconsin Running Injury and Recovery Index was successfully translated into the German language. Its usage may hold promise for better rehabilitation surveillance following running-related injuries. • The UWRI provides information on the recovery from a running-related injury. • This patient-reported outcome measure can be successfully translated and culturally adapted. • This study indicates its feasibility and validity in a clinical setting. • Usage of the UWRI may hold promise for better rehabilitation surveillance. [ABSTRACT FROM AUTHOR]

Background: The management of chronic kidney disease (CKD) and its complications places a significant burden on patients, resulting in impairment of their health-related quality of life (HR-QOL). Little is known about treatment-related burden in pre-dialysis and hemodialysis (HD) CKD patients.Objective: This study aimed to investigate the magnitude of treatment-related burden and its impact on HR-QOL among patients with CKD.Methods: This was a prospective, cross-sectional study to assess treatment-related burden and HR-QOL among patients with CKD in Qatar. Treatment-related burden and HR-QOL were assessed quantitatively using the Treatment Burden Questionnaire (TBQ) and the Kidney Disease Quality of Life (KDQOL™) questionnaire, respectively. The total TBQ score ranges from 0 to 150, with a higher score indicating higher treatment burden, while the range of total possible scores for the KDQOL™ are from 0 to 3600 with higher transformed score indicating better QOL. Pre-dialysis and hemodialysis (HD) CKD patients who had regular follow-up appointments at Fahad Bin Jassim Kidney Center in Qatar were enrolled. Data were analyzed descriptively and inferentially using SPSS version-24.Results: Two hundred-eighty CKD patients (HD = 223 and pre-dialysis = 57) were included in the analyses (response rate 60.9%). Approximately 35% of the participants reported moderate to high treatment-related burden (TBQ global score 51-150). HD patients experienced significantly higher treatment burden compared to pre-dialysis patients with a median (IQR) score of 45 (36) versus 25 (33), respectively (p < 0.001). Medication burden and lifestyle changes burden were the highest perceived treatment-related burden. Overall, the perceived median (IQR) HR-QOL measured using the KDQOL-36™ among the participants was 2280.6 (1096.2) compared to the maximum global score of 3600. Similarly, the HD patients demonstrated significantly lower HR-QOL compared to the pre-dialysis patients [median (IQR) score of 2140 (1100) vs. 2930 (995), respectively; p < 0.001). There was a strong negative correlation between TBQ score and KDQOL-36™ score [rs (251) = -0.616, p < 0.001], signifying that HR-QOL decreases as treatment burden increases.Conclusions: This study suggests that a considerable proportion of CKD patients suffered from treatment-related burden and deterioration in HR-QOL at a varying degree of seriousness. HD patients experienced significantly higher burden of treatment and lower HR-QOL compared to pre-dialysis patients and that HR-QOL declines as treatment burden increases. Therefore, treatment-related burden should be considered in CKD management and factors that increase it should be considered when designing healthcare interventions directed to CKD patients. [ABSTRACT FROM AUTHOR]

This paper presents the results of a randomized controlled trial (RCT) that focus on health-related quality-of-life (QoL) and patient-reported satisfaction following breast reconstruction with pedicled flaps from the back. We included women for unilateral delayed breast reconstruction. Patients were randomized to reconstruction by either a latissimus dorsi (LD) flap or a thoracodorsal artery perforator (TAP) flap. Assessment of QoL and patient satisfaction was made using two different patient-reported outcome measures (PROMs): The EORTC QLQ-30 and the Breast-Q questionnaire for post-mastectomy breast reconstruction. A total of 50 women were enrolled over a two-year period and allocated to reconstruction. Forty patients completed both surgery and follow-up and were included in the analysis – 18 in the LD group and 22 in the TAP group. The EORTC QLQ-30 was administered at the baseline and at one-year follow-up. There was no significant effect of introducing the TAP flap on either the summary score, the global QoL-score or the financial impact-score when compared to the LD flap. The Breast-Q questionnaire was administered only at one-year follow-up. There was no significant difference between the two groups for the scores for satisfaction with the reconstructed breast, the overall outcome and QoL related to psycho-social, sexual and physical well-being. Women from both groups report high satisfaction and QoL following the reconstruction. The quality of the dataset and the study design are, however, insufficient to rule out any existing difference. A larger cohort, longer follow-up and different design are warranted to assess the true clinical significance these reconstructions might have on satisfaction and QoL. [ABSTRACT FROM AUTHOR]

Patient experience of motor recovery from denervation paralysis is complex and textured. The Medical Research Council (MRC) system of grading muscle peak volitional force is widely used as a single measure of assessment. However, it is becoming clear that current motor function assessments are not reflecting the patient lived experience of muscle reinnervation. Therefore, this study aimed to engage international expert nerve surgeons in a classical Delphi process to achieve a consensus of opinion on the ideal clinical assessment of motor function. This was compared with patient-reported impairments of reinnervated muscle. Invitations to engage in the Delphi process were extended to expert peripheral nerve surgeons across two international specialist meetings. For comparison, patients who attended a "Nerve Injury Community Day" were invited to complete a questionnaire on patient-reported impairments of reinnervated muscle. Questions were designed on the basis of a literature review and the clinical experiences of a specialist nerve injury unit. A combination of direct yes/no, multiple choice, open-ended and Likert questions were employed throughout the questionnaires. Eighteen surgeons engaged with the Delphi process; 18 and 11 responded to the first and second rounds respectively. Thirty-one patients responded to the questionnaire. It was found that clinicians were strongly biased towards efferent assessments of muscular function, while patients strongly favoured muscular fatigue, co-contraction and pain when monitoring their own recovery. The findings suggest that current clinical assessments of muscular function are inadequate and should embody measurements of afferent muscular function to better reflect the lived experience of muscle reinnervation. [ABSTRACT FROM AUTHOR]

Background: Despite the success of total hip arthroplasty (THA), approximately 10%-15% of patients will be dissatisfied with their outcome. Identifying patients at risk of not achieving meaningful gains postoperatively is critical to pre-surgical counseling and clinical decision support. Machine learning has shown promise in creating predictive models. This study used a machine-learning model to identify patient-specific variables that predict the postoperative functional outcome in THA.Methods: A prospective longitudinal cohort of 160 consecutive patients undergoing total hip replacement for the treatment of degenerative arthritis completed self-reported measures preoperatively and at 3 months postoperatively. Using four types of independent variables (patient demographics, patient-reported health, cognitive appraisal processes and surgical approach), a machine-learning model utilizing Least Absolute Shrinkage Selection Operator (LASSO) was constructed to predict postoperative Hip Disability and Osteoarthritis Outcome Score (HOOS) at 3 months.Results: The most predictive independent variables of postoperative HOOS were cognitive appraisal processes. Variables that predicted a worse HOOS consisted of frequent thoughts of work (β = -0.34), frequent comparison to healthier peers (β = -0.26), increased body mass index (β = -0.17), increased medical comorbidities (β = -0.19), and the anterior surgical approach (β = -0.15). Variables that predicted a better HOOS consisted of employment at the time of surgery (β = 0.17), and thoughts related to family interaction (β = 0.12), trying not to complain (β = 0.13), and helping others (β = 0.22).Conclusions: This clinical prediction model in THA revealed that the factors most predictive of outcome were cognitive appraisal processes, demonstrating their importance to outcome-based research.Level Of Evidence: Prognostic Level 1. [ABSTRACT FROM AUTHOR]

Despite more than 30 years of research, pain in the emergency department (ED) setting is frequently undertreated. EDs prioritise process measures that often have tenuous links to patient-reported outcomes. However, process measures, such as time to the administration of first analgesic medication, are neither direct objective measures of analgesia nor appropriate surrogate markers of pain relief. Since pain is a subjective symptom that lacks an objective measure, pain research in any clinical environment, including EDs, should rely upon patient-reported outcomes. This scoping review examined patient-reported outcomes (PROs) and patient-reported outcome measures (PROMs) of pain care in the adult emergency department at the micro, meso and macro-level over the last ten years. We reviewed pain care research conducted on adults in EDs over the last ten years and identified 57 articles using 14 patient-reported outcomes of pain care falling into five broad areas, most without validation or adaption to the ED setting. Despite efforts made to incorporate PROs and PROMs into acute pain care research in the ED over the last ten years, there is still no gold-standard PROM in widespread use. We recommend the adaptation of existing tools with rigorous validation in ED populations. [ABSTRACT FROM AUTHOR]

Incorporating the patient's perspective into the entire product life cycle of medical device development is paramount for ensuring patient-centric evaluation. By prioritizing patient-centric evaluation, medical device developers can better address patient needs and enhance the quality and effectiveness of health care solutions. Patient-reported outcomes (PROs), patient preference information (PPI), and qualitative inquiry are methodologies to incorporate and amplify the patient's voice. In nephrology, unlike in other clinical domains, the utilization of PROs, PPI, and qualitative inquiry in medical device development has been notably sparse. Consequently, a glaring absence of patient involvement in the development of devices leaves the impact of these devices on patient well-being and functionality largely unexplored. Many forward-thinking programs as well as Food and Drug Administration guidance on the use of PROs and PPI are effectively bringing PROs into nephrology device development. Many resources exist to help researchers select high-quality PROs. There are unique considerations for using PROs and PPI to support regulatory decision-making, including fit-for-purpose, concepts of interest, context of use, and least burdensome selection. The rapid evolution of patient-centric initiatives in nephrology will serve to ensure that medical devices meet the needs of people with kidney disease and improve the quality of care. [ABSTRACT FROM AUTHOR]

• There is good consistency between accelerometry and International Physical Activity Questionnaire in people with MS with mild disability. • International Physical Activity Questionnaire and Godin Leisure Time Questionnaire do not adequately reflect physical activity in people with MS with moderate to severe disability. • An MS-specific self-reported questionnaire for assessing physical activity in pwMS with different degrees of ambulatory impairment is warranted. • Disability and aerobic capacity are significant predictors of physical activity in people with MS. Accelerometers and patient-reported outcomes (PRO) are used to assess physical activity (PA) in people with multiple sclerosis (pwMS). So far it is unknown, however, whether these assessments represent mobility limitations in pwMS with mild and moderate to severe disability alike. The primary aim of the study was to assess the correlation between accelerometry and International Physical Activity Questionnaire (IPAQ) scores in pwMS with different degrees of ambulatory impairment. Taken its frequent use into account, the Godin Leisure Time Exercise Questionnaire (GLTEQ) was investigated as additional PRO. In a prospective cohort of pwMS, correlational analyses were performed between the number of daily steps, time spent in light, moderate to vigorous PA (MVPA) and time spent sitting as assessed using accelerometry (ActiGraph®-GT3X), and the respective IPAQ and GLTEQ scores. Additionally, associations of PA with disease-specific characteristics, aerobic capacity (VO2 peak), walking assessments (Timed 25-Foot Walk, T25FW; 2-Minute Walk Test, 2MWT) and walking perception (Multiple Sclerosis Walking Scale-12; MSWS-12) were explored. Patient subgroups with mild (Expanded Disability Status Scale; EDSS score <4.0) and moderate to severe disability (EDSS ≥4.0) were analysed for the impact of ambulatory impairment on PA. Multiple linear regression was used to determine predictors of PA. A total of 56 pwMS completed the study, with a mean (standard deviation, SD) age of 48.4 (10.3) years, disease duration of 14.8 (9.6) years and median (interquartile range) EDSS score of 3.5 (2.0 – 4.4). Moderate to weak correlations were found between daily step count and IPAQ total metabolic equivalent (MET) minutes/week (p < 0.001; r = 0.506), MVPA MET-minutes/week (p < 0.01; r = 0.479) and walking MET-minutes/week (p < 0.05; r = 0.372) in the total cohort. Time spent sitting was inversely correlated with total MET-minutes/week and MVPA MET-minutes/week (p < 0.05; r = -0.358 and r = -0.365). Subgroup analysis revealed, that daily step count was significantly correlated with total MET-minutes/week, MVPA MET-minutes/week and walking MET-minutes/week (p < 0.01, r = 0.569; p < 0.01, r = 0.531 and p < 0.05, r = 0.480, respectively) in the "mild disability" subgroup only, whereas time spent sitting was inversely correlated with total MET-minutes/week (p < 0.05; r = -0.582) in the "moderate to severe disability" subgroup. There was no association between objectively assessed PA and GLTEQ scores in any group. In the total cohort, moderate to weak correlations were found between daily step count and walking assessments (T25FW: p < 0.01, ρ = -0.508; 2MWT: p < 0.01, ρ=0.463) and MSWS-12 (p < 0.001; ρ = -0.609). Moderate to weak correlations were also observed between VO2 peak and walking assessments (T25FW: p < 0.01; ρ = -0.516; 2MWT: p < 0.01, ρ=0.480). Multiple linear regression analysis identified disability and VO2 peak as predictors of PA (p = 0.045; β=0.25 and p < 0.001; β=0.49). Significant associations of objective PA measurements using accelerometry with IPAQ were found only in pwMS with "mild disability". In pwMS with "moderate to severe disability", IPAQ did not reflect the objectively assessed amount of PA. In our cohort, GLTEQ showed no association with objectively assessed PA. Thus, an MS-specific self-reported questionnaire for assessing PA is warranted. [ABSTRACT FROM AUTHOR]

Disorders of gut–brain interaction are characterized by chronic gastrointestinal symptoms in the absence of abnormal endoscopic or radiologic findings or objective biomarkers that can be identified during routine clinical evaluation. The assessment of the symptom pattern and severity, therefore, is the key modality to evaluate the presence, impact, and evolution of these conditions, for both clinical and regulatory purposes. Patient-reported outcomes are structured symptom assessment questionnaires designed to evaluate symptom patterns, quantify severity of symptoms, and evaluate response to treatment at follow-up. This review provides an overview of currently available patient-reported outcomes for evaluating the main disorders of gut–brain interaction, specifically, functional dyspepsia; irritable bowel syndrome; and chronic constipation. It summarizes their content, level of validation for clinical practice and for research, and the regulatory approach to these conditions. Expected future developments and need for further research on patient-reported outcomes for these and other disorders of gut–brain interaction are highlighted. [ABSTRACT FROM AUTHOR]

We evaluated the 1-year postoperative clinical and patient-reported outcomes in patients who had a 3-dimensional planned corrective osteotomy of their distal radius, radial shaft, or ulnar shaft using a printed, anatomical, patient-tailored plate to determine the feasibility and effectiveness of this methodology. Simulations in computer-assisted preoperative planning of corrective osteotomies resulted in 3-dimensionally printed surgical guides, surgical models, and anatomically customized plates for application at the distal radius and forearm. Patients with malunions of the distal radius or forearm who underwent fixation with the custom-made plates were documented in our registry. Grip strength and range of motion assessments were made before surgery (baseline), as well as at 6 weeks and 3 and 12 months. Additionally, patients rated their wrist-related pain and disability using the Patient-Rated Wrist Evaluation. Fifteen patients underwent corrective surgery, and the 1-year follow-up data of 14 patients with a median age of 56 years (interquartile range, 24–64 years) were available for analysis. The median baseline Patient-Rated Wrist Evaluation score improved from 47 to 7 after 1 year. The flexion-extension arc of motion of the wrist increased from 90° at baseline to 130° at 1 year and the pronation-supination arc of motion of the wrist increased from 135° to 160° in the same time period. Differences in radiological measurements for palmar and radial inclinations, as well as for ulnar variance between the affected and contralateral wrists, were reduced with the osteotomy. In 1 case, the plate was removed 11 months after the osteotomy. No severe adverse events were reported. Three-dimensionally planned and printed patient-tailored plates offer a reliable method for correcting even complex malunions of the distal radius and forearm. Therapeutic IV. [ABSTRACT FROM AUTHOR]

Background and Aim The inflammatory bowel disease [IBD]-disk is a 10-item self-questionnaire that is used to assess IBD-related disability. The aim of the present study was to evaluate this tool in the assessment of IBD daily-life burden. Methods A 1-week cross-sectional study was conducted in 42 centres affiliated in France and Belgium. Patients were asked to complete the IBD-disk [best score: 0, worst score: 100] and a visual analogue scale [VAS] of IBD daily-life burden [best score: 0, worst score: 10]. Analyses included internal consistency, correlation analysis, and diagnostic performance assessment. Results Among the 2011 IBD outpatients who responded to the survey [67.8% of the patients had Crohn's disease], 49.9% were in clinical remission. The IBD-disk completion rate was 73.8%. The final analysis was conducted in this population [ n = 1455 patients]. The mean IBD-disk score and IBD daily-life burden VAS were 39.0 ± 23.2 and 5.2 ± 2.9, respectively. The IBD-disk score was well correlated with the IBD daily-life burden VAS [r = 0.67; p <0.001]. At an optimal IBD-disk cut-off of 40, the area under the receiver operating characteristic curve [AUROC] for high IBD daily-life burden [VAS >5] was 0.81 (95% confidence interval [CI]: 0.79–0.83; p <0.001). Conclusions In a large cohort of patients, the IBD-disk score was well correlated with IBD daily-life burden, and it could be used in clinical practice. [ABSTRACT FROM AUTHOR]

Background: Resection arthroplasty has long been a major treatment option for forefoot deformity caused by rheumatoid arthritis (RA). However, metatarsophalangeal (MTP) joint–preserving surgery is now surpassing classic resection arthroplasty. This study was performed to compare the postoperative results of these 2 operative methods. Methods: Fifty-one toes of 40 patients with RA who underwent resection arthroplasty (resection group) or MTP joint–preserving arthroplasty (preservation group) from 2014 to 2017 for forefoot deformity were followed up for >1 year and were retrospectively analyzed. In the preservation group, open reduction of joint dislocation was performed if needed, and the deformity was corrected by metatarsal shortening osteotomy. The mean follow-up period was 21 months. The Japanese Society for Surgery of the Foot (JSSF) scales (objective outcome measures), the Self-Administered Foot Evaluation Questionnaire (SAFE-Q) (subjective outcome measure), and radiographic indices were compared between the groups. The resection group and preservation group comprised 15 toes of 11 patients and 36 toes of 29 patients, respectively. Results: There were no significant differences in the preoperative radiographic indices, JSSF scales, or SAFE-Q results between the 2 groups. The preservation group showed better JSSF scores at the last follow-up (median hallux scale, 89 vs 74; median lesser scale, 87 vs 79). In the preservation group, the SAFE-Q scores gradually improved with time until 12 months postoperatively. In the resection group, the scores decreased 3 months postoperatively and then improved and reached a plateau 6 months postoperatively. At 12 months postoperatively, there was no significant difference in the SAFE-Q scores between the 2 groups. Conclusions: MTP joint–preserving arthroplasty resulted in superior objective scores to resection arthroplasty in patients with RA forefoot deformity. Although the subjective scores did not differ between the groups at the last follow-up, the time course of postoperative quality of life improvement was different between the 2 surgeries. Level of Evidence: Level III, retrospective comparative study. [ABSTRACT FROM AUTHOR]

As patient-reported outcome (PRO) measures are being included more frequently in oncology clinical trials, regulatory and health technology assessment agencies have begun to request long-term, post-treatment PRO data to supplement traditional survival/progression endpoints. These data may be collected as part of cohort extension or registry studies to describe long-term outcomes of study participants after concluding their cancer treatment. While post-treatment PRO data may be expected to satisfy regulatory and payer expectations, significant practical barriers exist for the efficient incorporation of these data into oncology clinical trials, such as subject attrition, protocol deviations, and treatment crossover. The incorporation of post-treatment PRO assessments is a resource-intensive task requiring clear objectives for how the data will be analyzed and interpreted by both sponsors and regulators. Incorporating PRO data collection via electronic modalities (e.g., smartphone, web) may be a less expensive and more feasible option for incorporating long-term follow-up, reducing the frequency of manual study staff follow-up and expensive clinic visits. It is essential to include well-defined estimands for the statistical analysis, as well as to document limitations associated with the long-term follow-up data-collection approach. Analytical techniques will likely rely on descriptive and model-based statistics, and conclusions about treatment differences will likely be limited to preliminary findings of effectiveness (instead of efficacy). Finally, communications with health authorities and regulatory agencies regarding the LTFU study design and analysis should occur as early as possible to ensure that the PRO data to be collected offer an opportunity to properly evaluate the research question(s) of interest. [ABSTRACT FROM AUTHOR]

Patient-reported outcomes (PROs) are increasingly recognized in pediatric clinical care as adding essential information relevant to actual care. However, the effectiveness of using PROs in pediatric clinical settings has not been fully explored with synthesized evidence. The aim of this study was to evaluate the effectiveness of using patient-reported outcomes in pediatric clinical practices. We searched four English and three Chinese databases to identify studies that examine the effectiveness of using PROs in pediatric clinical practices published from the inception date of each database to January 2020. Ten articles met the inclusion criteria. There was wide a variation in the ten studies' designs, samples, PROs administered (type, length, timing, mode), and type of outcomes evaluated. The effect sizes of using PROs on three categories of outcomes (patient, process of care and health service) were assessed. Of 70 measured outcomes, 32 were positive, 5 were negative, and 33 were mixed. Overall, there is a weak but trending positive impact of using PROs in pediatric clinical practice. More rigorous study designs with sources of bias controlled are needed to more directly assess the impact of using PROs in pediatric care. If findings continue to be positive, then an implementation model addressing the numerous influencing factors is recommended to integrate PROs into pediatric care. • This review represents the current status of the impact of PROs in pediatric health care. • A weak but trending positive impact of using PROs in pediatric care was noted. • Strategies are needed to integrate and sustain PRO use in pediatric care. [ABSTRACT FROM AUTHOR]

Objective: We sought to determine if chronic rhinosinusitis (CRS) patients with nasal polyps (CRSwNP) differentially perceived CRS symptom burden compared to patients without nasal polyps (CRSsNP) and to what extent CRS symptom severity was associated with quality of life (QOL) and patient-reported symptom control in the 2 groups. Methods: A total of 600 patients (266 CRSwNP and 334 CRSsNP) presenting with CRS were recruited. CRS symptom burden was assessed with the 22-item Sinonasal Outcome Test (SNOT-22). SNOT-22 nasal, sleep, ear/facial discomfort, and emotional subdomain scores were calculated. General health-related QOL was assessed with the visual analog scale of the 5-dimensional EuroQol questionnaire (EQ-5D VAS). Patients rated their CRS symptom control on a 5-point scale. Results: SNOT-22 scores did not differ between CRSwNP (mean: 35.6) and CRSsNP (mean: 36.3). There were no differences in nasal, sleep, and emotional subdomains of the SNOT-22. CRSsNP had higher (P =.003) ear/facial subdomain scores than CRSwNP, while CRSwNP reported greater hyposmia (P <.001). EQ-5D VAS was significantly lower (P =.011) in CRSsNP (mean: 68.9) compared to CRSwNP (mean: 73.2). However, CRSwNP patients reported significantly less symptom control, compared to CRSsNP, in association with nasal and emotional symptoms. Conclusion: CRSwNP and CRSsNP have differences in symptom profile, effect on health-related QOL, and patient-perceived symptom control. CRSsNP experience significantly greater burden of ear/facial discomfort, while CRSwNP report greater hyposmia. Although CRSsNP reports lower general health-related QOL overall, CRSwNP patients had lower levels of CRS symptom control for every incremental increase in symptom burden suggesting greater sensitivity/intolerance to CRS symptoms. [ABSTRACT FROM AUTHOR]