Comparing Rates of Minimal Clinically Important Difference Between Manual and Robotic-Assisted Total Knee Arthroplasty.

BACKGROUND: Differences in patient-reported outcome measures (PROMs) between manual total knee arthroplasty (mTKA) and robotic-assisted TKA (rTKA) have not been adequately assessed. We compared the minimal clinically important difference for improvement (MCID-I) and Worsening (MCID-W) between mTKA and rTKA patients. METHODS: Patients who underwent primary TKA (874 mTKA, 439 rTKA) with complete pre-operative and one-year post-operative PROMs were retrospectively identified using a multi-hospital joint arthroplasty registry. Patient-Reported Outcomes Measurement Information System Physical Function Short Form 10a (PROMIS PF-10a), PROMIS Global - Physical, or Knee Injury and Osteoarthritis Outcome Score-Physical Function Short Form (KOOS-PS) were collected. The MCID-I, MCID-W, and "no significant change" rates were calculated using distribution-based methods. Propensity-score matching was performed to control for confounding. RESULTS: Similar 90-day pulmonary embolism (P = 0.26), deep venous thrombosis (P = 0.67), and emergency department visit (P = 0.35) rates were found. The 90-day readmission rate for mTKA was 1.7 and 3.4% for rTKA (P = 0.08), and overall revision rates were 2.2% for mTKA and 0.7% for rTKA (P = 0.07). Revision-free survival was 99% at one and two years for both groups (P = 0.65 and P = 0.43, respectively). There were no differences in the proportion of patients achieving MCID-I or MCID-W for PROMIS PF-10a, PROMIS Global - Physical, or KOOS-PS. The MCID-I for PROMIS PF-10a was achieved in 65.5 and 62.2% of patients who had mTKA and rTKA, respectively (P = 0.32). CONCLUSION: Our study demonstrated similar complication rates, and MCID-I and MCID-W attainment rates between mTKA and rTKA patients. Future studies should assess MCID attainment rates in the long term and in larger cohorts, comparing mTKA and rTKA.

Daily physical activity and prognostic implications in patients with heart failure: an accelerometer study.

BACKGROUND: Physical activity (PA) measured by accelerometry is proposed as a novel trial endpoint for heart failure (HF). However, standardised methods and associations with established markers are lacking. This study aimed to examine PA measurements and accelerometer repeatability in patients with HF and age- and sex-matched controls, and study correlations with established prognostic HF markers, body composition, and quality of life (QoL). METHODS: Accelerometry was performed in 105 patients with HF with left ventricular ejection fraction (LVEF) ≤ 40% and in 46 controls. Participants also underwent dual X-ray absorptiometry, cardiopulmonary exercise testing, a six-minute walking test (6MWT), echocardiography, and NT-proBNP measurement, and completed a QoL questionnaire. RESULTS: Average acceleration was markedly reduced in patients with HF compared with healthy controls (16.1 ± 4.8 mg vs 27.2 ± 8.5 mg, p < 0.001). Healthy controls spent a median daily 56 min (IQR 41-96 min) in moderate-to-vigorous PA (MVPA), whereas HF patients spent only 12 min (IQR 6-24) in MVPA. In HF patients, average acceleration correlated moderately with 6MWT (R = 0.41, p < 0.001) and maximal oxygen uptake (peak VO2) (R = 0.36, p < 0.001) but not with NT-proBNP, LVEF, or QoL. Patients in NYHA class II showed a higher average acceleration than patients in NYHA III (16.6 ± 4.9 mg vs 14.0 ± 3.6 mg, p = 0.01). CONCLUSIONS: Daily PA was severely reduced in patients with HF compared with healthy controls. In HF patients, we found moderate correlations of accelerometer measurements with markers of physical capacity but not with LVEF or NT-proBNP. TRIAL REGISTRATION: NCT05063955. Registered 01 June 2021-retrospectively registered.

Non-inferiority, randomised, open-label clinical trial on the effectiveness of transurethral microwave thermotherapy compared to prostatic artery embolisation in reducing severe lower urinary tract symptoms in men with benign prostatic hyperplasia: study protocol for the TUMT-PAE-1 trial.

BACKGROUND: One-fourth of men older than 70 years have lower urinary tract symptoms (LUTS) that impair their quality of life. Transurethral resection of the prostate (TURP) is considered the gold standard for surgical treatment of LUTS caused by benign prostatic hyperplasia (BPH) that cannot be managed conservatively or pharmacologically. However, TURP is only an option for patients fit for surgery and can result in complications. Transurethral microwave thermotherapy (TUMT) and prostatic artery embolisation (PAE) are alternative minimally invasive surgical therapies (MISTs) performed in an outpatient setting. Both treatments have shown to reduce LUTS with a similar post-procedure outcome in mean International Prostate Symptom Score (IPSS). It is however still unknown if TUMT and PAE perform equally well as they have never been directly compared in a randomised clinical trial. The objective of this clinical trial is to assess if PAE is non-inferior to TUMT in reducing LUTS secondary to BPH. METHODS: This study is designed as a multicentre, non-inferiority, open-label randomised clinical trial. Patients will be randomised with a 1:1 allocation ratio between treatments. The primary outcome is the IPSS of the two arms after 6 months. The primary outcome will be evaluated using a 95% confidence interval against the predefined non-inferiority margin of + 3 points in IPSS. Secondary objectives include the comparison of patient-reported and functional outcomes at short- and long-term follow-up. We will follow the patients for 5 years to track long-term effect. Assuming a difference in mean IPSS after treatment of 1 point with an SD of 5 and a non-inferiority margin set at the threshold for a clinically non-meaningful difference of + 3 points, the calculated sample size was 100 patients per arm. To compensate for 10% dropout, the study will include 223 patients. DISCUSSION: In this first randomised clinical trial to compare two MISTs, we expect non-inferiority of PAE to TUMT. The most prominent problems with MIST BPH treatments are the unknown long-term effect and the lack of proper selection of candidates for a specific procedure. With analysis of the secondary outcomes, we aspire to contribute to a better understanding of durability and provide knowledge to guide treatment decisions. TRIAL REGISTRATION: ClinicalTrials.gov NCT05686525. Registered on January 17, 2023, https://clinicaltrials.gov/study/NCT05686525 .

Patient-reported outcome measures for medication treatment satisfaction: a systematic review of measure development and measurement properties.

BACKGROUND: Medication Treatment Satisfaction (M-TS) from the patients' perspective is important for comprehensively evaluating the effect of medicines. The extent to which current patient-reported outcome measures (PROMs) for M-TS are valid, reliable, responsive, and interpretable remains unclear. To assess the measurement properties of existing PROMs for M-TS and to highlight research gaps. METHODS: Using PubMed, Embase (Ovid), Cochrane library (Ovid), IPA (Ovid), PsycINFO, Patient-Reported Outcome and Quality of Life Questionnaires biomedical databases, and four Chinese databases, we performed a systematic search for studies addressing the development and validation of PROMs for M-TS. Based on the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) guideline, pairs of reviewers independently assessed the measurement properties of the PROMs and rated the quality of evidence on the measurement properties of each PROM. (The Open Science Framework registration: https://doi.org/10.17605/OSF.IO/8S5ZM ). RESULTS: This review identified 69 PROMs for M-TS in 114 studies (four generic, 32 disease-specific, and 33 drug-specific) of which 60 were intended for adults. All provided limited or no information regarding interpretability. Most demonstrated appropriate construct validity including convergent validity (39/69) and discriminative or known-groups validity (40/69) (high to moderate quality of evidence). Only a few provided evidence of sufficient content validity (8/69), structural validity (13/69), and internal consistency (11/69). Of 38 PROMs reporting test-retest reliability, results in 24 provided evidence of satisfactory test-retest reliability (18 with high to moderate, 6 with low to very low quality of evidence). Few PROMs reported responsiveness (16/69). Two generic PROMs (Treatment Satisfaction Questionnaire for Medication initial Version 1.4, TSQM-1.4; Treatment Satisfaction with Medicines Questionnaire, SATMED-Q) and one drug-specific PROM (Insulin Treatment Satisfaction Questionnaire, ITSQ) demonstrated both satisfactory validity and reliability. CONCLUSIONS: Most existing PROMs for M-TS require further exploration of measurement properties. Reporting guidelines are needed to enhance the reporting quality of the development and validation of PROMs for M-TS.

Complications after benign gynecologic surgery-How are they captured in register-based research? A national register study in Sweden.

INTRODUCTION: The evidence on complication rates after gynecological surgery is based on multiple types of studies, and the level of evidence is generally low. We aimed to validate the registration of complications in the Swedish National Quality Register of Gynecological Surgery (GynOp), by cross-linkage to multiple national registers. MATERIAL AND METHODS: A national register-based study using prospectively collected data was conducted, including women who had surgery on the uterus or adnexa for benign indications from January 1, 2017, to December 31, 2020. In Sweden, complications after gynecological surgery are registered in GynOp, and if the complication has rendered any interaction with healthcare, it is also in national health registers. The GynOp register, the National Patient Register, the Prescribed Drugs Register, and the Cause of Death Register were cross-linked. Complications in GynOp and complications according to ICD10 were analyzed, as well as the cause of death if occurring within 3 months of surgery and prescription of antibiotics ≤30 days. Comparisons between the registries were descriptive. RESULTS: During the study period 32 537 surgeries were performed, of which 26 214 (80.6%) were minimally invasive. Complications were reported in GynOp for 569 women (1.7%) at surgery, 1045 (3.2%) while admitted, and 3868 (13.7%) from discharge to 3 months after surgery. In comparison, according to the Patient Register, 2254 women (6.9%) had postoperative complications within 3 months of discharge (difference of 6.8 percentage points [95% confidence interval 6.2-7.2]). Furthermore, 4117 individuals (12.7%) had a prescription of antibiotics ≤30 days which could indicate a postoperative infection. The rates of hemorrhage, wound dehiscence, and thrombosis were comparable between GynOp and the Patient Register while diagnoses not leading to contact with specialized care had higher rates in the quality register. The coverage of complications was 79.1% in GynOp and 46.1% in the Patient Register, using the total number of complications from both registers as the denominator. CONCLUSIONS: A higher frequency of complications is captured in GynOp than in the National Patient Register. Patient-reported outcomes assessed by a physician are beneficial in identifying complications indicating the importance of structured pre-defined follow-up over a set period.

Robotic Assisted TKA achieves adjusted mechanical alignment targets more consistently compared to manual TKA without improving outcomes.

Introduction: Robotic total knee arthroplasty (rTKA), with its purported advantages of more accurate alignment, greater functional outcomes and patient satisfaction, is gaining popularity in patients undergoing TKA. The purpose of our study was to compare these parameters along with gait pattern and kneeling ability in a cohort of patients who underwent simultaneous TKA with manual instrumentation (mTKA) and rTKA in contralateral knees at a 1-year follow-up. Methods: This was a retrospective review of 135 consecutive patients who underwent simultaneous bilateral TKA using robotic assistance on one side and manual instrumentation on the contralateral side between January 2022 and June 2022. The target alignment in both cohorts was adjusted mechanical. Patients were followed up at 3, 6 and 12 months to assess and compare alignment, range of motion (ROM) and patient-reported outcome measures (PROM) data. Gait parameters and kneeling ability were assessed at 1-year follow-up. Results: While adjusted mechanical alignment was achieved in all rTKA patients, we recorded five outliers (≥3° with relation to 180° HKA axis) in the mTKA cohort (three varus and two valgus). There were no significant differences between both cohorts with regards to ROM, PROM scores, gait analysis parameters and kneeling ability at 1-year follow-up. Conclusion: rTKA helps in achieving the adjusted mechanical alignment more consistently than mTKA. This, however, does not contribute to better functional outcomes and patient satisfaction at 1-year follow-up. Level of Evidence: Level III.

A quick balance assessment tool for all clinical settings: validity and reliability of the Hungarian version of the activities-specific balance confidence scale.

BACKGROUND: The Activities-specific Balance Confidence Scale was developed for testing the balance confidence of elderly individuals, and it has been used extensively for evaluating various patients. No such scale has been adapted for the Hungarian population. OBJECTIVE: To translate and culturally adapt the Activities-specific Balance Confidence Scale and test the reliability and validity of the Hungarian version. METHODS: The study included 167 independently mobile subjects, of whom 39 filled in the questionnaire twice, 1 week apart. Beaton's six-step principle was applied for cross-cultural adaptation. Reliability was assessed by internal consistency measured by Cronbach's alpha and through test-retest analysis. Types of validity evaluated were concurrent validity using the Berg Balance Scale and cross-cultural validity. RESULTS: Excellent internal consistency was shown by Cronbach's alpha = 0.977. Test-retest analysis resulted in an Intra-Class Correlation Coefficient of 0.962 (0.865-0.961, 95% CI, p < .001) for the whole test; no floor or ceiling effects were found. The convergent validity of the scale was tested by Spearman's rank correlation analysis using the Berg Balance scale for external validation and showed a strong positive correlation (Rho = 0.755, p < .001). Receiver Operating Characteristic curve analysis showed an Area Under the Curve of 0.821 (CI 95% 0.75, 0.892). Mean detectable change based on the 95% confidence interval was 10.49% on the scale ranging from 0 to 100%. CONCLUSIONS: The Hungarian version of the Activities-Specific Balance Confidence Scale provides a valid and reliable picture of the patients' self-assessed balance. It is recommended both for clinicians and for clinical studies.

Danish translation, cultural adaptation and psychometric testing of the Brachial Assessment Tool (BrAT), designed to assess activity limitation in adults with traumatic brachial plexus injuries.

PURPOSE: To translate and cross-culturally adapt The Brachial Assessment Tool (BrAT) into Danish and assess its content validity and reproducibility in adults with traumatic brachial plexus injury (BPI). MATERIAL AND METHODS: Translation followed international guidelines. BrAT(DK) were cognitive tested with 19 adults with traumatic BPI to evaluate cross-cultural understanding, relevance, comprehensiveness and comprehensibility. Content validity and reproducibility were evaluated following the COnsensus-based Standards for the selection of health Measurement INstruments guideline. Participants were recruited from an outpatient hand clinic. Test-retest reliability was assessed using intra-class-correlation coefficient (ICC) and the smallest detectable change (SDC). Internal consistency was evaluated using Cronbach's alpha. RESULTS: Minor cultural differences were observed in the content validity analysis of BrAT(DK). Cognitive testing revealing no significant issues. All participants found the items relevant and important. 63 participants with traumatic BPI were recruited; 49 completed the retest. ICC values for the sub-scales and the total score ranged from 0.91 to 0.95 (95% CI 0.85 to 0.97). Internal consistency ranged from 0.87 to 0.98. SDC ranged from 4.16 to 9.63 for subscales and 16.01 for the total score. CONCLUSION: BrAT(DK) appeared to be content valid and reliabel as a measure of activity limitation in adults with traumatic BPI.

The Brachial Assessment Tool (BrAT) has been cross-cultural translated into DanishBrAT(DK) shows adequate content validity for activity limitation in adults with traumatic brachial plexus injuryBrAT(DK) is a reliable measure, with a smallest detectable change of 16.01 points for the total scaleWe recommend the use of BrAT(DK) in clinical practice to inform goal setting and future interventions and treatment evaluations.

A framework for best practices in clinical outcome assessment (COA) concept mapping: a case study.

PURPOSE: Mapping or matching the items in a clinical outcome assessment (COA) to concepts that define a condition is a common method for evaluating a COA's concept coverage. The purpose of this research was to address the lack of formal guidance for conducting this task by developing a framework for best practices in COA concept mapping and applying it to a case study. METHODS: To develop the framework, we examined the literature and created a draft set of best practices which was then reviewed by experienced researchers through focus groups before being finalized. To conduct the case study, we extracted data from a systematic review of knee osteoarthritis (KO) symptoms and impacts and used the framework to map relevant concepts to items in the SF-36v2® Health Survey (SF-36v2). RESULTS: The framework guides researchers in defining the purpose of and data sources for the mapping, establishing guiding principles and decision-making thresholds, and conducting the mapping exercise. The results of the case study demonstrate the usefulness of the framework in identifying 27/36 items (75%) in the SF-36v2 that addressed concepts that define KO. CONCLUSION: This case study illustrates how the framework for best practices in COA concept mapping may be used, highlighting how establishing clear concept definitions and guiding principles and following a structured process throughout can help produce consistent, reliable, and reproducible results. The results from this rigorous approach can provide valuable evidence to support decisions about the appropriateness of a COA for the intended patient population.

In health-related quality of life research, mapping items in a clinical outcome assessment (COA) to concepts that define a health condition is one way to evaluate an instrument's content validity (or, how well the instrument addresses the concepts it intends to measure). Without formal guidance on how to do this mapping, researchers can be inconsistent. This article describes the development of a framework for best practices in COA concept mapping. Informed by the literature and input from researchers with expertise in COA development and evaluation, the final framework guides researchers through the mapping process from start to finish, from helping to define the purpose of the task and identify the data sources, to establishing guiding principles and decision-making thresholds, conducting the mapping, and displaying the results. A case study­in which items from the SF-36v2^® Health Survey were mapped to concepts from a systematic review of knee osteoarthritis symptoms and impacts­shows the framework in action, demonstrating how following the best practices can lead to consistent results that can support the evaluation of an instrument's content validity.

Disease characteristics and medications use in idiopathic inflammatory myopathy: a multi-center prospective observational study of decentralized remote vs. traditional clinic enrollment.

OBJECTIVES: Idiopathic Inflammatory Myopathies (IIM) are rare and characterized by heterogeneous manifestations and clinical trajectories. Utilizing tele-research methods has the potential to improve participant recruitment and advance the understanding of the disease. We aimed to evaluate disease characteristics in IIM patients throughout the U.S. and compare these parameters between patients recruited remotely through mobile application or website vs those recruited locally in myositis clinics. METHODS: "Myositis Patient Centered Tele-Research" (My PACER) is a multicentre prospective observational study of U.S. IIM subjects, competitively recruited through traditional in-person clinic visits (Center-Based Cohort [CBC]), and remotely using mobile application or website and social media (Tele-Research Cohort [TRC]). Data collection comprised baseline demographic and clinical variables, encompassing symptoms, organ involvement, diagnostic tests results and medication use. RESULTS: The study included 120 IIM patients, 82 in the TRC and 38 in the CBC. The average age was 55 ± 13.4, 75% females and 81% Caucasians. Both cohorts exhibited similar demographic characteristics. Overall, 41% dermatomyositis, 27% polymyositis, 23% anti-synthetase syndrome, and 9% necrotizing myositis patients were enrolled, with comparable subtypes prevalence among cohorts (p= 0.85). The groups demonstrated similarities in multiple clinical factors, including muscle enzymes, diagnostic delay, employment status, various patient and physician-reported outcomes, functional tests, and the frequency of abnormal findings in chest CT, pulmonary function tests, and electromyography. TRC patients received biologics and csDMARDs more frequently (p< 0.001 and p= 0.013, respectively). CONCLUSION: Tele-research recruitment yielded a patient cohort resembling traditionally recruited patients demographically and clinically, indicating its effectiveness for robust and diverse patient recruitment in clinical studies.

Exploring Diet-Based Treatments for Atrial Fibrillation: Patient Empowerment and Citizen Science as a Model for Quality-of-Life-Centered Solutions.

Atrial fibrillation (AF) is the most common heart rhythm disorder in the Western world. Between the years 2010 and 2019, the global prevalence of AF rose from 33.5 million to 59 million, highlighting the importance of developing equitable treatments for patients. The disease is associated with symptoms such as palpitations, dizziness, fatigue, shortness of breath, and cognitive dysfunction. In addition, AF increases the risk of developing a stroke and heart failure. Despite new insights into risk factors that can lead to the development of AF, the success of current treatments is suboptimal. Numerous risk factors, such as hypertension, diabetes, and obesity, have been associated with the development and progression of AF. As these can be lifestyle-related risk factors, lifestyle modification may be a solution to reduce AF-related symptoms as well as episodes. Research results show that certain dietary changes can reduce AF and numerous risk factors for AF. Increasing attention is being given to Mediterranean and whole, plant-based eating patterns, which emphasize eating grains, legumes, vegetables, fruits, and nuts, while excluding most-or all-animal products. Hence, what are the beneficial aspects of a Mediterranean and plant-based diet which consists mainly of unprocessed foods? In the current review, we discuss the outcomes of diet-based treatments. Moreover, other diet-related treatments, brought up by patient initiatives, are highlighted. These patient-initiated studies include L-glutamine and electrolytes as options to manage AF. Also, we highlight the emerging importance of valuing patient needs and a quality-of-life-centered approach to medicine. As indicated by recent studies and patient experiences, citizen science can create inclusive solutions that lead to patient empowerment and a holistic approach for AF management.

Current use of patient-reported outcome measures by musculoskeletal physiotherapists in Portugal.

BACKGROUND: Musculoskeletal conditions are the leading cause of disability, requiring continuous outcome measurement, including the utilization of patient-reported outcome measures (PROMs). OBJECTIVE: The aims of the study were a) to characterize the use PROMs by Portuguese physiotherapists in patients with musculoskeletal conditions; b) to analyze the associated factors of their use and; c) to identify the barriers and facilitators to their implementation. METHODS: A cross-sectional online survey was carried out with musculoskeletal physiotherapists working in Portugal. Closed questions were used to describe the use of PROMs. The factors associated with the non-use of PROMs were analysed through logistic regression models (p= 0.05). Barriers and facilitators were assessed through open questions and analyzed using thematic analysis. RESULTS: One hundred and fifty-six physiotherapists answered the online survey. Most physiotherapists do not use outcome measures consistently and physical tests are often chosen (70.5%) over PROMs (17.3%). The work sector (p= 0.01; p= 0.015; p= 0.009). the workplace stimulus (p= 0.001) and the physiotherapists' knowledge about PROMs (p= 0.017) were identified as factors associated with the non-use of PROMs. Barriers and facilitators to the use of PROMs are related to physiotherapists' skills, the patients' characteristics, the workplace conditions, and the instruments' characteristics. CONCLUSION: This study showed the poor use of PROMs by musculoskeletal physiotherapists and identified the associated factors, barriers, and facilitators that should be considered to increase its future use by musculoskeletal physiotherapists in Portugal.

Early Postoperative Patient-Reported Outcomes of Sarcopenia Versus Nonsarcopenia in Patients Undergoing Video-Assisted Thoracoscopic Surgery for Lung Cancer.

BACKGROUND: To compare early postoperative patient-reported outcomes between sarcopenic and nonsarcopenic patients undergoing video-assisted thoracoscopic surgery (VATS) for lung cancer. METHODS: The data used in this study were acquired from a longitudinal prospective study (CN-PRO-Lung 1) between November 2017 and January 2020. Skeletal muscle index was measured at L3 vertebral level on preoperative computed tomography to identify sarcopenia based on an established threshold. Symptoms severity and status of functional impairments were reported as proportions of patients with clinically relevant moderate-to-severe scores on 0-10 scales, which were measured by using the MD Anderson Symptom Inventory-Lung Cancer at baseline, daily postoperative hospitalization, and weekly after discharge up to 4 weeks. Symptom severity, functional status, and postoperative clinical outcomes were compared between the sarcopenia and nonsarcopenia groups. RESULTS: This study included 125 patients undergoing VATS for lung cancer. Sarcopenia was identified in 34 (27.2%) patients. Sarcopenic patients reported more moderate-to-severe pain (P = 0.002) at discharge and more moderate-to-severe fatigue (P = 0.027) during the 4 weeks after discharge. Besides, sarcopenic patients had a longer recovery time from both pain (P = 0.002) and fatigue (P = 0.007) than nonsarcopenic patients. Meanwhile, no significant between-group difference was found in the postoperative clinical outcomes (all P > 0.05). CONCLUSIONS: Sarcopenic patients undergoing VATS for lung cancer may have more pain and fatigue, as well as longer symptoms recovery time than nonsarcopenic patients during the early postoperative period.

A short scale to measure health-related quality of life after traumatic brain injury in children and adolescents (QOLIBRI-OS-KID/ADO): psychometric properties and German reference values.

PURPOSE: The impact of pediatric traumatic brain injury (pTBI) on health-related quality of life (HRQoL) in children and adolescents remains understudied. Short scales have some advantages in terms of economy and administration over longer scales, especially in younger children. The aim of the present study is to psychometrically evaluate the six-item German version of the QOLIBRI-OS-KID/ADO scale for children and adolescents. In addition, reference values from a general German pediatric population are obtained to assist clinicians and researchers in the interpretation of HRQoL after pTBI. METHODS: A total of 297 individuals after TBI and 1997 from a general population sample completed the questionnaire. Reliability, validity, and comparability of the assessed construct were examined. RESULTS: The questionnaire showed satisfactory reliability (α = 0.75 and ω = 0.81 and α = 0.85 and ω = 0.86 for the TBI and general population samples, respectively). The QOLIBRI-OS-KID/ADO was highly correlated with its long version (R2 = 67%) and showed an overlap with disease-specific HRQoL (R2 = 55%) in the TBI sample. The one-dimensional factorial structure could be replicated and tested for measurement invariance between samples, indicating a comparable HRQoL construct assessment. Therefore, reference values and cut-offs indicating clinically relevant impairment could be provided using percentiles stratified by factors significantly associated with the total score in the regression analyses (i.e., age group and gender). CONCLUSION: In combination with the cut-offs, the QOLIBRI-OS-KID/ADO provides a cost-effective screening tool, complemented by interpretation guidelines, which may help to draw clinical conclusions and indications such as further administration of a longer version of the instrument to gain more detailed insight into impaired HRQoL domains or omission of further steps in the absence of an indication.

Sensory Neuropraxia After Distal Biceps Repair is Not Associated With Patient-Reported Outcomes or Satisfaction: A Retrospective Cohort Study.

BACKGROUND: Cutaneous neuropraxia is the most common complication following distal biceps tendon repair (DBTR). Currently, no patient demographic factors have been implicated in its occurrence, course, or resolution. The purpose of this study is to explore various patient demographics and their association with postoperative neuropraxia. Further it investigates how mental health scores correlate with patient-reported outcomes, and whether occurrence of neuropraxia alters this association. METHODS: This retrospective review evaluates a consecutive series of patients who underwent distal biceps repair with a single-incision cortical button technique. Patients with reported outcome data at a minimum of 1 year (n = 47) were included for analysis. Demographic data including age, sex, body mass index (BMI), diabetes, smoking status, and occurrence of neuropraxia were recorded. Patient-reported outcome measures (PROMs) include the American Shoulder and Elbow Surgeons-Elbow (ASES-E) score, Single Assessment Numeric Evaluation (SANE) score, Visual Analog Scale (VAS) for pain, Disabilities of the Arm, Shoulder, and Hand Score (QuickDASH), and Veterans RAND 12 (VR-12) Mental Component Score (MCS) and Physical Component Score (PCS) quality-of-life assessment. RESULTS: Postoperative neuropraxia of any duration occurred in 45% (21/47) of patients in this cohort following DBTR. Of these, 62% (13/21) reported resolution of symptoms by the latest follow-up. Mean time to resolution of neuropraxia was 148 days. Patient age, BMI, smoking history, time to surgery, tear thickness, and increasing surgeon experience across the study period were not significantly associated with the incidence or time to resolution of postoperative neuropraxia. Scores for patient satisfaction, VAS, ASES, QuickDASH, SANE, VR-12 MCS, VR-12 PCS, and flexion ROM did not differ significantly between patients with and without postoperative neuropraxia. CONCLUSION: Patient satisfaction following DBTR was not significantly associated with postoperative neuropraxia. Patient and surgical characteristics did not influence the occurrence or time to resolution of neuropraxia. The occurrence of postoperative neuropraxia did not result in significant functional limitations.

French-language questionnaires in ENT: Inventory and review.

OBJECTIVE: Patient-Reported Outcome Measures (PROMs) are now an integral part of clinical and academic practice in ENT, and it is essential to have tools with a validated French version. However, there are no guidelines on ENT questionnaires available in French or those that could have transcultural adaptation. METHODS: The present study, under the auspices of the ENT National Professional Council and the French Society of ENT, inventoried PROMs, for each super-specialty and pathology, meeting one of the following inclusion criteria: validated French version, not translated but used internationally (i.e., translated into other languages and widely cited since 2017), or subjectively deemed useful by experts in the super-specialty in question. RESULTS: In total, 103 questionnaires were identified. To encourage and accompany their intercultural adaptation and statistical validation, this article presents the rationale and methodology of such an undertaking. CONCLUSION: PROMs either already validated in French or which it would be useful to translate were inventoried. The methodology of translation and validation to guarantee reliability and relevance is presented.

Establishment of the Norwegian hearing register for children.

Introduction: The Norwegian Directorate of Health approved the Norwegian Hearing Register for Children in 2022. The main objective of the register is to improve the quality of treatment for children with permanent hearing loss, by measures, follow-ups and monitoring the quality and results of the health care system. Methods: Inclusion criteria are children who do not pass universal newborn hearing screening and/or children with permanent hearing loss <18 years of age. Hearing loss is defined as pure-tone audiometry threshold of (PTA4) > 20 dB in at least one ear. Data are registered at the Ear, Nose and Throat departments at inclusion and at follow-ups at the age of 3, 6, 10, and 15 years. The register collects information about the child within a holistic perspective. The key elements of the register are (a) data concerning newborn hearing screening; (b) data concerning hearing, medical information, hearing amplification and intervention (c) patient reported outcome measures registered by caregivers using three questionnaires; Pediatric Quality of Life Inventory, Strengths and Difficulties Questionnaire and Parents' Evaluation of Aural/Oral Performance of Children. Results: The register has established four quality indicators regarding newborn hearing screening and early intervention (a) the rate of false positive neonatal screens; (b) testing for congenital cytomegalovirus within 3 weeks of age for children who do not pass newborn hearing screening; (c) audiological evaluation to confirm the hearing status no later than 3 months of age and (d) initiated intervention within 3 months after confirmation of hearing status. Discussion: The register will include the total population of hearing impaired children over long time periods. Thus, the register enables each hospital to monitor their quality indicator scores continuously and compare them with national levels in real time. This facilitates and accelerates identification of improvement areas in the hospitals and will be an important contributor for quality improvement in NHS, diagnostics and hearing intervention for children in Norway. In addition, data from the register will be a unique source for research, and study designs with a long follow-up time can be applied.

Are Patient-Reported Outcome Measures for Anterior Cruciate Ligament Injuries Validated for Spanish Language and Culture?

Background: Patient-reported outcome measures (PROMs) have been adopted as a way to measure patient self-rated physical function and health status for patients with anterior cruciate ligament (ACL) injuries. Although multiple PROMs exist and have been translated into various languages, the cross-cultural adaptation and validity of these PROMs for Spanish-speaking patients is unknown. Purpose: To evaluate the adaptation quality and psychometric properties of Spanish-language adaptations of PROMs for patients with ACL injuries. Study Design: Scoping review; Level of evidence, 3. Methods: Under PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, we reviewed published studies related to adaptation quality and psychometric properties of Spanish PROMs in patients with ACL injuries. The methodological quality of the included studies was assessed using the Guidelines for the Process of Cross-Cultural Adaptation of Self-Reported Measures, the Quality Criteria for Psychometric Properties of Health Status Questionnaires, and the Consensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. The level of evidence for each PROM was determined based on the number of studies, methodological quality, consistency of results, and sample size. Results: The initial search strategy identified 5687 articles. After removal of duplicates, 1882 titles were screened, and 114 articles were assessed for eligibility. Six articles were selected for final review, comprising 4 PROMs: the Lysholm knee score, the Anterior Cruciate Ligament-Return to Sport After Injury (ACL-RSI), the Lower Extremity Functional Scale, and the Lower Limb Functional Index. Three studies followed all 6 processes for cross-cultural adaptation. None of the studies demonstrated all 14 domains required for cross-cultural validity (eg, description of translator expertise). The ACL-RSI achieved the highest level of evidence, with 3 of 9 domains demonstrating moderate evidence. Conclusion: This review identified 4 instruments that have been translated for Spanish-speaking patients with ACL injuries, none of which demonstrated appropriate adaptation or robust psychometric properties. The study highlights the need for improvement in PROMs for Spanish-speaking patients and the potential for mismeasurement and inappropriate application of PROM results in patients with ACL injuries.

Quality of life with diverticular disease: translation and validation of the German version of the diverticulitis quality of life questionnaire (DV-QOL).

BACKGROUND: The DV-QoL is a 17-item questionnaire measuring health-related quality of life in patients affected by symptomatic diverticular disease, covering four domains: physical symptoms, concerns, feelings, and behavioral changes. Given the lack of a diverticulitis-specific questionnaire to be used for German-speaking patients, we prospectively validated the German version of the DV-QoL. METHODS: German-speaking patients with CT-confirmed history of recurrent diverticular disease admitted to a Swiss surgical department completed the German version of the DV-QoL, along with short form-36 (SF-36) and the Gastrointestinal Quality of Life Index (GIQLI). Reliability was examined using exploratory and confirmatory factor analysis, a Martin-Loef test, and Cronbach's alpha. For convergent validity testing, correlations were calculated with the GIQLI and SF-36. Discriminant validity tests included age and gender. RESULTS: We included 121 patients, of whom 77 were admissions for elective surgery and 44 presented with acute diverticulitis treated conservatively. The DV-QoL's total score showed good correlations with the GIQLI (r = - 0.77) and its subscales (r = - 0.76 to - 0.45), as well as with the SF-36's subscales (r = - 0.30 to - 0.57). No relationships were found with age or gender (p < 0.05). The Cronbach's alpha coefficient was 0.89 over all items and 0.69, 0.90, 0.78, and 0.77 for the four separated domains (physical symptoms, cognitions/concerns, feelings, and behavioral changes, respectively). A nonsignificant Martin-Loef test indicated unidimensionality (p = 1), further supported by the exploratory factor analysis, which showed an item information sharing of 65%. CONCLUSION: The German DV-QoL questionnaire can be used as a valid and reliable disease-specific measure for quality of life in patients with recurrent diverticular disease.

Rhekiss-The German Register for Child Wish and Pregnancies in Inflammatory Rheumatic Diseases.

In pharmacoepidemiology, robust data are needed to judge the impact of drug treatment on pregnancy, pregnancy outcomes and breast-fed infants. As pregnant and breastfeeding women are usually excluded from randomised clinical trials, observational studies are required. One of those data sources are pregnancy registers specifically developed to focus on certain diseases or disease groups. The German Rhekiss register investigates pregnancies in women with chronic inflammatory rheumatic diseases (IRD). Rhekiss is a nationwide, multicentre, longitudinal study, in which women aged 18 years or older with an underlying IRD can be enrolled by a rheumatologist either when planning a pregnancy or in the first half of pregnancy. Data are collected prospectively at regular follow-up visits. Rheumatologists and patients provide information in a web-based system before conception (if enrolment was at the time of pregnancy planning), during and after pregnancy. A smartphone app is available for patients. Maternal and clinical information, general laboratory markers, treatment with antirheumatic and other drugs, adverse events, items related to course and outcome of pregnancy and the health of the child are uniformly assessed for all diseases. Individual information on the IRD includes classification criteria, diagnosis-specific laboratory parameters, clinical parameters and validated instruments to measure disease activity or damage. Furthermore, patient-reported outcome measures are captured. A total of 2013 individual patients have been enrolled in the register, and data on 1801 completed pregnancies are available. In summary, Rhekiss is a comprehensive and complex register that can answer various research questions about pregnancy in women with chronic IRDs.