BACKGROUND: In recent years, there has been an increasing demand for patient-reported outcome measures (PROMs) to assess the outcome following orthopedic surgery. But, we are lacking a standard set of PROMs to assess the outcome of hallux valgus surgery. The aim of this study was to analyze the chosen patient rated outcome scores used in studies reporting on hallux valgus surgery.
METHODS: The study was based on a previously published living systematic review. Included were prospective, comparative studies of different surgical procedures or the same procedure for different degrees of deformity. Four common databases were searched for the last decade. Study selection, data extraction, and risk of bias assessment were made by two independent reviewers. Data assessed were the individual PROMs used to assess the outcome of hallux valgus surgery.
RESULTS: 46 studies (30 RCTs and 16 non-randomized prospective studies) met the inclusion criteria. The most commonly used clinical outcome measures were the AOFAS (55%) and the VAS (30%). No differences were found between frequency of the individual scores per the level of evidence or the type of osteotomy.
CONCLUSIONS: Based on a systematic literature review, the AOFAS and VAS are the most frequently used outcome tools in studies assessing the outcome following hallux valgus surgery. Based on the literature available, the MOXFQ is a more valid alternative.
METHODS: Level I; systematic review of prospective comparative (level II) and randomized controlled trials (level I).

While evidence highlights increased activity levels following total ankle replacement (TAR), the correlation between postoperative activity changes and ankle-surgery-specific patient-reported outcomes is unexplored. This retrospective cohort study investigates the effect of activity level changes on patient-reported outcomes, including the Manchester-Oxford Foot Questionnaire (MOXFQ) and patient satisfaction following TAR. Patient records from a single center performing TARs between January 2014 and February 2023 were reviewed alongside patient questionnaires completed preoperatively and at a mean follow-up of 44±31 months postoperatively (range 6-134 months). Activity participation pre- and postoperatively was assessed and correlated with MOXFQ scores. Data from 89 patients was available for analysis (mean age 72.3±8.9 years [range, 48-92]). Postoperatively, 31 patients (35%) increased, 42 (47%) maintained, and 16 (18%) decreased their activity levels. The mean time to return to regular activity was 23.4 weeks. Preoperative MOXFQ scores were similar across all groups (increased: 74.03±14.00; maintained: 73.6±13.9; decreased: 77.0±15.5; p=0.71). All groups showed significant improvements in MOXFQ scores from preoperative to postoperative assessments (p<0.05). Patients with increased activity levels showed greater MOXFQ improvements (-61.6±19.0) compared to those with decreased activity levels (-38.3±26.6) (p<0.01). Following TAR, 82% of patients maintained or increased their activity levels. Patients with increased postoperative activity exhibited superior improvements in MOXFQ scores. These findings underscore the importance of promoting physical activity for optimal outcomes following TAR. LEVEL OF CLINICAL EVIDENCE: Level 3, retrospective cohort study.

BACKGROUND: Predicting which patients will get meaningful benefit from total knee arthroplasty remains a challenge. Our aim was to assess if pre-operative quality of life (EuroQol 5-Dimension, 5-Level instrument; EQ-5D-5L) can predict the likelihood of a patient achieving post-operative improvement in patient-reported outcome measures (PROMS) following total knee arthroplasty to a level of minimum clinically-important difference (MCID).
METHODS: This was a retrospective analysis of a prospective cohort of total knee arthroplasty patients. EQ-5D-5L and Oxford Knee Scores (OKS) were recorded pre-operatively, 6 months and 2 years post-operatively. The primary outcome measure was achievement of MCID in EQ-5D-5L at 2 years. Multivariable analysis through multiple logistic regression was performed to assess for independent predictors of MCID in EQ-5D-5L, OKS and re-operation at 2 years.
RESULTS: 400 patients were included, with 57% female and a mean age of 66 years. Pre-operative EQ-5D-5L was the only strong predictor of post-operative EQ-5D-5L MCID (OR: 0.016, CI: 0.004 to 0.06), when adjusted for age, gender, BMI, ASA, smoking status and surgeon grade. The optimal pre-operative EQ-5D-5L threshold was found to be 0.53 by Youden\'s index, with a sensitivity of 70% and specificity of 73%.
CONCLUSIONS: Pre-operative quality of life as measured by EQ-5D-5L is a strong independent predictor of reaching MCID in EQ-5D-5L following total knee arthroplasty. Those with worse EQ-5D-5L are more likely to gain meaningful benefit from knee arthroplasty.

OBJECTIVE: The impairments and duration of PASC (post-acute sequelae of COVID-19) symptoms in mental health have, to date, not been comprehensively examined. Our objective is to provide longitudinal data on the mental health of Post-COVID patients and to identify risk and protective factors associated with a severe or prolonged course.
METHODS: The mental health of 265 Post-COVID patients of the outpatient Post-COVID centre of the University Hospital Erlangen was assessed 17.1 (T0) and 22.5 months after infection (T1). An online survey with validated questionnaires for Post-COVID symptoms (Post-COVID Syndrome Score), depression (Patient Health Questionnaire-9), somatic symptoms (Patient Health Questionnaire-15), anxiety (Generalized Anxiety Disorder-7), fatigue (Fatigue Severity Scale) and Post-Exertional Malaise (PEM) (DePaul Post-Exertional Malaise Screening) was conducted in the home environment.
RESULTS: In total, 80% of patients experienced severe PASC at follow-up. Clinically relevant symptoms of depression, persistent somatic symptoms, anxiety and fatigue were reported by 55.8%, 72.5%, 18.9% and 89.4% of patients, respectively. Depressive, anxiety and somatic symptom severity decreased significantly over time; fatigue and PEM remained at an unchanged high level. The risk factor for higher depression scores was older age; prior psychiatric illness treated with psychotherapy was associated with more severe depressive, somatic, anxiety and PASC symptoms. PEM symptoms were significantly associated with longer duration between acute infection and initial presentation in the Post-COVID centre.
CONCLUSIONS: Our findings align with previous research, claiming severe mental health symptoms in PASC syndrome, lasting for months after infection. In-depth assessment of risk and protective factors for the mental health implications of PASC is needed for the planning of health services and disease prevention.

There is a clinical need to better understand and improve post-operative pain for patients undergoing laparoscopic repair of incisional hernia. The aim of this single-centre, double-blind, randomised controlled trial was to compare post-operative pain between absorbable and non-absorbable tack fixation in patients undergoing IPOM + repair. Patients with primary incisional hernia (size 3-10 cm), were randomised to either Reliatack™ (n = 27), an articulating-arm device deploying absorbable polymer tacks, or Protack™ (n = 36), a straight-arm device deploying permanent titanium tacks. The primary outcome was reported pain on activity using a visual analogue scale at post-operative day 30. Clinical and patient-reported outcome measures (PROMs) were assessed pre-operatively (day 0), and at 1-, 6-, 30- and 365-days post-surgery. No significant differences in reported pain \'on activity\' were found at any timepoint. Less reported pain \'at rest\' was found on post-operative day-1 with absorbable tacks (p = 0.020). Significantly longer mesh-fixation time (p < 0.001) and the use of more knots for fascial closure (p = 0.006) and tacks for mesh-fixation (p = 0.001) were found for the absorbable tack group. There were no differences in other clinical and PROMs between groups. For the whole trial cohort (n = 63) several domains in the Short-Form-36 showed a reduction from baseline scores at day 30 that improved at day 365. At post-operative day 30, 75.0% of patients reported \'a lot of pain\' since discharge. This study found no difference in reported pain when choosing absorbable or non-absorbable tack fixation. The utility of \"early\" post-operative pain assessment as a comparator following incisional hernia repair needs clarification.

BACKGROUND: Achilles tendon (AT) disorders significantly impact patient life, necessitating accurate assessment tools. Current methods are often complex and time-consuming. This study aims to validate the Simple Ankle Value (SAV) for AT disorders.
METHODS: A multicenter study was conducted involving 101 participants, including a surgical, a conservative, and a control group. Participants completed the SAV, VISA-A, and EFAS scores. The study assessed correlations among scores, reliability, responsiveness to change, threshold and ceiling effect and discriminative ability of the SAV.
RESULTS: There was a significant strong correlation with the EFAS and a significant moderate to strong correlation with the VISA-A. The score showed excellent reliability (ρ = 0.95, 95 %CI: [0.913; 0.976], p < 0.001). Responsiveness to change was significant between preoperative and postoperative SAV (37.99 ± 25.73 vs 70.86 ± 21.26). The SAV discriminated between patient and controls with no threshold or ceiling effect.
CONCLUSIONS: The SAV provides a valid, reliable, and responsive method for assessing AT disorders. It offers a simplified and effective alternative to more complex scores.
METHODS: Cohort study (Diagnosis); Level of evidence, 2.

OBJECTIVE: The purpose of this study was to examine reported MCID and PASS values for PROMs following shoulder instability surgery and assess variability in published values depending on the surgery performed. Secondarily, our aims were to describe the methods used to derive MCID and PASS values in the published literature, including anchor-based, distribution-based, or other approaches, and to assess the frequency of MCID and PASS usage in studies on shoulder instability surgery.
METHODS: A systematic review of MCID and PASS values following Bankart, Latarjet, and Remplissage procedures was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA). The Embase, Pubmed, and Cochrane Central Register of Controlled Trials (CENTRAL) databases were queried from 1985 to 2023. Inclusion criteria included studies written in English, and studies reporting utilization MCID or PASS for patient reported outcome measures (PROMS) following Latarjet, Bankart, Remplissage approaches for shoulder instability surgery. Extracted data included study population characteristics, intervention characteristics, and outcomes of interest. Continuous data were described using median and range. Categorical variables, including PROMs reported and MCID/PASS methods, were described using percentages. As MCID is a patient-level metric and not a group-level metric, the authors validated that all included studies reported proportions (%) of subjects that met or exceeded the MCID.
RESULTS: A total of 174 records were screened, and 8 studies were included in this review. MCID was the most widely utilized outcome threshold which was reported in all 8 studies, with only 2 studies reporting both the MCID and the PASS. The most widely studied PROMs were the American Shoulder and Elbow Surgeons (ASES) (range 5.65-9.6 for distribution MCID, 8.5 anchor MCID, 86 anchor PASS); Single Assessment Numeric Evaluation (SANE) (range 11.4-12.4 distribution MCID, 82.5-87.5 anchor PASS); visual analog scale (VAS) (range 1.1-1.7 distribution MCID, 1.5-2.5 PASS); Western Ontario Shoulder Instability Index (WOSI) (range 60.7-254.9 distribution MCID, 126.43 anchor MCID, 571-619.5 anchor PASS); and Rowe scores (range 5.6-8.4 distribution MCID, 9.7 anchor MCID). Notably, no studies reported on substantial clinical benefit (SCB) or maximal outcome improvement (MOI).
CONCLUSIONS: Despite the wide array of available PROMs for assessing shoulder instability surgery outcomes, the availability of clinically significant outcome thresholds such as MCID and PASS remains relatively limited. While MCID has been the most frequently reported metric, there is considerable inter-study variability observed in their values.
CONCLUSIONS: Knowing the outcome thresholds such as MCID and PASS of the PROMs frequently used to evaluate the results of glenohumeral stabilization surgery is fundamental, since they allow us to know what is a clinically significant improvement for the patient.

Reducing the burden of disease for patients and families requires being able to measure health status changes related to disease severity, control, and response to treatment over time. Patient-reported outcomes are patient perceptions of their health status. Such perceptions are critical to decision making. Some patient-reported outcome measures (PROMs) are extensive and often intended to be used only for detailed research assessments. Many PROMs, however, form critical components of valid, reliable, and responsive assessments in clinical research and routine clinical practice. The smallest score change in a PROM that would lead to different decision making by patients is called the minimally important difference. Using PROMs may also offer advantages over general questions or unvalidated tools. With the innovation of technology, the ability to chronicle disease symptoms using communication technology (mobile phone applications) has become increasingly available. Collection of real-world data in this capacity will be very useful for identifying more precise phenotypes/endotypes necessary for investigation of tailored therapies for chronic spontaneous and inducible urticaria, angioedema, and atopic dermatitis. Here, we provide an overview of PROMs that have been developed for the assessment of disease severity, control, and quality of life and that have been validated for the use of adults and children with these skin disorders.

BACKGROUND: Simulation of aesthetic outcomes of wide local excision and level one oncoplastic breast conserving treatment (BCT) using 3-dimensional surface imaging (3D-SI) prepares women for their aesthetic outcome. It remains unknown whether women\'s memory of this information at the one-year follow-up matches their perception of reality or affects the quality of life.
METHODS: With ethical approval, a prospective 3-arm RCT was conducted and it included 3D-simulation, viewing post-operative 2D photographs of other women and standard care. At one-year post-surgery, the participants completed a visual analogue scale (VAS) for the question \"How well do you think the information about how your breasts are likely to look after surgery reflects how they actually look today?\" and the BCT BREAST-Q module. The Kruskal-Wallis test was used to examine between-group differences at a 5% significance level.
RESULTS: From 2017 to 2019, 117 women completed the primary endpoint of being informed about the aesthetic outcome via verbal description, photographs or simulation. Seventy-eight (74%) of the 106 women who remained eligible attended the one-year follow-up. The standardised preoperative 3D-SI simulation did not affect the patient\'s perception of the aesthetic outcome compared to standard care or viewing 2D photographs as measured using the VAS (p = 0.40) or BREAST-Q scores for satisfaction with information (p = 0.76), satisfaction with breasts (p = 0.70), and psychosocial wellbeing domains (p = 0.81).
CONCLUSIONS: Viewing their own 3D-SI standardised simulation did not significantly affect how the participants perceived their aesthetic outcome. In addition, it did not alter the patient-reported satisfaction. These results demonstrated that simulation for wide local excision or level one oncoplastic surgery does not set unrealistic expectations of the aesthetic outcome when used in a preoperative setting.
CONCLUSIONS: The use of a non-bespoke three-dimensional simulation of the aesthetic outcome for breast conserving treatment in the preoperative setting does not over-inflate expectations compared to standard care.

UNASSIGNED: Lipoedema is a painful adipose tissue disorder, affecting the limbs of women, that is resistant to diet and exercise. The purpose of the study was to evaluate the retrospective health-related quality-of-life (HRQoL) outcomes for patients with lower limb lipoedema (LLL) following tumescent liposuction (TL).
UNASSIGNED: Forty-seven patients received TL over 5 years from 2015-2020 for LLL. As part of their routine treatment evaluation, each patient completed 4 validated HRQoL questionnaires at initial assessment. The questionnaires examined the patients\' experiences relating to anxiety and depression, lower extremity function, appearance, and symptoms. The same questionnaires were posted to the patients after an average of 12 months post-procedure/s to establish the outcomes of the intervention.
UNASSIGNED: The study demonstrated that patients\' HRQoL improved at 12 months (average) following TL. The results of all the questionnaires were statistically significant, and patients with stage 3 LLL showed the most improvement in outcomes.
UNASSIGNED: The findings demonstrated that TL achieves positive HRQoL outcomes in patients with LLL; however, long-term follow-up is needed to determine if the benefits sustain. Additionally, larger prospective controlled studies are required to provide robust evidence for this procedure.