Search

Background: With increasing focus on patient-reported outcome measures (PROMs) in chronic rheumatic diseases, we aimed to evaluate the self-reported physical and psychosocial health in children with juvenile idiopathic arthritis (JIA) compared to matched population-based controls. Furthermore, we aimed to study the association of patient- and physician-reported outcome measures in JIA with patient-reported physical disability. Methods: We used data from a Norwegian JIA cohort study (NorJIA), including clinical characteristics and outcome measures in participants with JIA and sex- and age-matched population-based controls. Self-reported physical and psychosocial health were assessed using the generic Child Health Questionnaire (CHQ). Comparisons between children with JIA and controls were performed by test of proportions for categorical variables and t-test for continuous variables. To evaluate the association of patient- and physician-reported outcome measures with patient-reported physical disability, assessed with the Child Health Assessment Questionnaire (CHAQ) in children with JIA, we used logistic regression to estimate adjusted odds ratio (OR) with 95% confidence interval (CI). Results: In total, 221 participants with JIA (59.3% females, median age 12.7 years) and 207 controls with available data were included. In the JIA group, 24.3% scored below the norm for physical health (CHQ PhS < 40) and 8.7% scored below the norm for psychosocial health (CHQ PsS < 40). The corresponding numbers for the control group were 0.5% and 1.9%, respectively. In the JIA group, 57.9% reported physical disability (CHAQ > 0). Several patient-reported outcome measures, such as poor physical health (CHQ PhS < 40), disease-related pain, and the patient's global assessment of disease impact on wellbeing, were strongly associated with self-reported physical disability (CHAQ > 0), adjusted OR 19.0 (95% CI 5.6, 64.1), 14.1 (95% CI 6.8, 29.2), and 14.0 (95% CI 6.2, 31.6), respectively. Associations were also found for active disease according to Wallace (adjusted OR 36.3, 95% CI 10.3, 128.1), and physician-reported global assessment of disease activity (adjusted OR 6.2, 95% CI 3.1, 12.6). Conclusions: The strong association between patient- and physician-reported outcome measures and patient-reported physical disability strengthens the importance of including the patient's voice in a comprehensive evaluation of patient outcome in JIA. Trial registration: ClinicalTrials.gov (No: NCT03904459). [ABSTRACT FROM AUTHOR]

Background: With over 65,000 new cases per year in Germany, prostate cancer (PC) is the most common cancer in men in Germany. Localized PC is often treated by radical prostatectomy and has a very good prognosis. Postoperative quality of life (QoL) is significantly influenced by the side effects of surgery. One possible approach to improve QoL is postoperative symptom monitoring using ePROMs (electronic patient-reported outcome measures) to accurately identify any need for support. Methods: The PRO-P ("Influence of ePROMS in surgical therapy of PC on the postoperative course") study is a randomized controlled trial employing 1:1 randomization at 6 weeks postoperatively, involving 260 patients with incontinence (≥ 1 pad/day) at six participating centers. Recruitment is planned for 1 year with subsequent 1-year follow-up. PRO-monitoring using domains of EPIC-26, psychological burden, and QoL are assessed 6, 12, 18, 24, 36, and 52 weeks postoperatively. Exceeding predefined PRO-score cutoffs triggers an alert at the center, prompting patient contact, medical consultation, and potential interventions. The primary endpoint is urinary continence. Secondary endpoints refer to EPIC-26 domains, psychological distress, and QoL. Aspects of feasibility, effect, and implementation of the intervention will be investigated within the framework of a qualitative process evaluation. Discussion: PRO-P investigates the effect on postoperative symptom monitoring of a structured follow-up using ePROMs in the first year after prostatectomy. It is one of the first studies in cancer surgery investigating PRO-monitoring and its putative applicability to routine care. Patient experiences with intensified monitoring of postoperative symptoms and reflective counseling will be examined in order to improve primarily urinary continence, and secondly other burdens of physical and psychological symptoms, quality-of-life, and patient competence. The potential applicability of the intervention in clinical practice is facilitated by IT adaption to the certification standards of the German Cancer Society and the integration of the ePROMs survey via a joint patient portal. Positive outcomes could readily translate this complex intervention into routine clinical care. PRO-P might improve urinary incontinence and QoL in patients with radical prostatectomy through the structured use of ePROMs. Trial registration: ClinicalTrials.gov NCT05644821. Registered on 09 December 2022. [ABSTRACT FROM AUTHOR]

Background: Cancer patients benefit from Virtual Reality (VR) in burdensome situations, but evidence is scarce for palliative situations. Based on earlier work in palliative care, individualized VR interventions like seeing the patient's home may address a patient's wish to be at home and thus have a greater effect compared to standard VR content. Yet, some patients and relatives may be concerned about their privacy. Also, patient stakeholders raised concerns about triggering depressed mood or homesickness. Aim: To test the feasibility and safety of individualized vs. standard 360°video VR interventions in palliative cancer inpatients. Methods: Prospective observational study with patient-reported outcome measurement using validated instruments of well-being (MDBF), symptoms and psychosocial burden (IPOS), cybersickness (SSQ), presence experience (SPES), subjective benefit (2 items), content analysis of interviews, and field notes. Individualized VR content was recorded with action camcorder-technology to protect the patients' privacy. Results: Seventeen patients participated, median age 65 years (range 20–82), 9 women (53%), 8 single or widowed (47%), 4 childless (23.5%), 4 academics (23.5%), with a median length of stay of 9 days (1–75) in the hematology (10), palliative care (3), or radiotherapy (2) unit of a German university hospital. Eight patients (53.3%) chose their own home environments or family for individualized VR-content. All participants enjoyed the intervention. Compared to standard VR content the individualized VR tended to have a stronger effect on well-being and emotional touch. It was not inferior in terms of psychosocial burden and cybersickness. No subjective and relevant side effects occurred. The patients well tolerated the assessments. However, most patients demanded a lighter headset and a desire for more interactivity. Conclusions: Individualization of VR content shows potential for enhancement of immersion, which improves the VR experience and does not harm in terms of depressed mood or worsening of symptoms. The patients' and family desire for privacy is feasible with the support of family members who recorded the individualized videos, which is easily manageable today. We suggest a pragmatic randomized clinical trial to compare the effects of individualized vs. standard VR-content. Trial registration: Registered at German Clinical Trials Register (Deutsches Register Klinischer Studien; DRKS); registration number: DRKS00032172; registration date: 11/07/2023. [ABSTRACT FROM AUTHOR]

Introduction: Chronic Obstructive Pulmonary Disease (COPD) profoundly affects physical, psychological, and social aspects of life, yet these issues often remain unaddressed. Patient-Reported Outcomes Measures (PROM) have the potential to address these issues by promoting person-centered communication. However, their impact in COPD practice remains uncertain. This study aimed to investigate how patients with COPD perceive the usefulness of a new holistic PROM for general palliative care (PRO-Pall) before and during outpatient consultations. Methods: Semi-structured telephone interviews were conducted with patients diagnosed with moderate to very severe COPD, 2-5 days after consultation at a respiratory outpatient clinic in Denmark. Interviews were transcribed verbatim and analyzed inductively using qualitative content analysis. Results: Nine patients (five males; mean age: 66 years) participated in the study with four themes emerging: (1) Unlocking thoughts: Completing PRO-Pall stimulated patients' self-reflection, which revealed previously overlooked COPD-related issues, particularly psychosocial challenges. (2) Unmasking concerns: Patients felt encouraged to be honest, rather than concealing their concerns. (3) Breaking the ice: PRO-Pall responses enabled direct questioning by healthcare professionals during consultations, initiating discussions on patients' sensitive yet vital COPD-related matters. (4) Deepening the dialogue: Healthcare professionals' targeted and attentive approach fostered more holistic and meaningful discussions, providing most patients with a deeper understanding of psychosocial issues affecting their well-being. Conclusion: Completing PRO-Pall prior to outpatient consultations prompted most patients with COPD to unveil previously unacknowledged psychosocial challenges. During consultations, addressing these challenges initiated open discussions on individual concerns, enhancing most patients' understanding of the multifaceted burden of COPD. [ABSTRACT FROM AUTHOR]

Background: Inadequate pain relief with moderate to severe pain remains a challenge after cesarean section and may significantly impair postoperative recovery. However, detailed assessment on the timing of severe pain, opioid consumption, influence on activities such as mobilization, breastfeeding, and caring for the infant are difficult to conduct, especially after discharge. Short message services (SMS)‐based questionnaires may offer a low‐cost way of providing such data but with the risk of insufficient response rates. We assessed the feasibility of collecting detailed, prospective data on postoperative pain and recovery during the initial hours and days following cesarean section using SMS‐based questionnaires. Methods: Prospective Danish single‐center cohort study involving elective cesarean sections under spinal anesthesia with fentanyl and bupivacaine. The postoperative pain regimen consisted of paracetamol, NSAID and oral morphine by request. Patients received an SMS‐based questionnaire at 6, 12, 18, 24, and 48 h postoperatively, as well as on days 7 and 30. Primary outcome: Response rate and time from receiving the SMS to completion of the questionnaires. Secondary outcomes: Opioid consumption and Patient Reported Outcomes Measures on pain and recovery. Results: From December 2022 to June 2023; 100 patients were included. The response rate was 78% at 6 h postoperatively, decreasing to 63% at 24 h. The median response time from receiving to answering the SMS‐based questionnaire at 6 h after cesarean section was 23 min (IQR 2–72), decreasing to 20 min (IQR 2–78) after 24 h. Severe pain, corresponding to a Numeric Rating Scale (NRS) score >6, was reported by 57% (95% CI 65–84) at 6 h, decreasing to 28% (95% CI 34–58) at 24 h. Median opioid consumption within the first 24 h was 30 mg (IQR 20–50). Conclusion: SMS‐based questionnaires on Patient Reported Outcome Measures are a feasible and cost‐effective way of prospectively collecting frequent data with acceptable response rates, even shortly after cesarean section. Secondarily 66% of patients reported severe pain during the first 24 h following cesarean section, with the highest pain scores within the initial 12 h. Future studies should focus on optimizing pain‐management within this timeframe. [ABSTRACT FROM AUTHOR]

Background: There have been a large number of patient-reported outcome measures (PROMs) used to assess outcomes after anterior cruciate ligament (ACL) reconstruction (ACLR). Purpose/Hypothesis: The purpose was to determine which PROMs are being commonly used in randomized clinical trials (RCTs) to assess patients undergoing ACLR and to compare the responsiveness between them. It was hypothesized that the International Knee Documentation Committee (IKDC) score would be the most commonly used and responsive PROM among patients undergoing ACLR. Study Design: Meta-analysis. Level of evidence, 2. Methods: PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were followed, and relevant studies were extracted from the PubMed/MEDLINE and Web of Science databases. The inclusion criteria were English-language RCTs reporting on PROMs after ACLR. For articles meeting our inclusion criteria for responsiveness analysis (≥2 PROMs reported, 1 year minimum follow-up, and reported pre- and postoperative PROM means and standard deviations), the responsiveness between PROMs was compared using effect size (ES) and relative efficiency (RE). Results: A total of 108 articles met the inclusion criteria, comprising 9034 patients (mean age, 29.9 years; mean body mass index, 24.3; mean follow-up time, 36.1 months). There were 34 PROMs identified. The top 3 most commonly reported PROMs were the IKDC (n = 68; 63.0%), Lysholm (n = 65; 60.2%), and Tegner (n = 47; 43.5%) scores. The 2 PROMs with the highest ES were the ACL–Quality of Life (QoL) (3.37) and Knee Injury and Osteoarthritis Outcome Score (KOOS) QoL (2.07) scores. Compared with other PROMs, Lysholm and KOOS QoL scores had the greatest RE values. The Lysholm score had a greater RE than the KOOS Pain (RE, 1.17), KOOS Symptoms (RE, 1.22), KOOS Activities of Daily Living (ADL) (RE, 1.42), KOOS Sport/Recreation (RE, 1.55), KOOS QoL (RE, 1.41), and Tegner (RE, 2.89) scores. KOOS QoL had a greater RE than the IKDC (RE, 1.32), KOOS Pain (RE, 1.60), KOOS Symptoms (RE, 2.12), KOOS ADL (RE, 3.03), KOOS Sport/Recreation (RE, 1.27), and Tegner (RE, 2.06) scores. Conclusion: The IKDC score is the most commonly reported PROM in RCTs after ACLR; however, the Lysholm and KOOS QoL scores demonstrated the highest responsiveness in patients undergoing ACLR compared with other PROMs. [ABSTRACT FROM AUTHOR]

Background: Multiple patient-reported outcome measures (PROMs) have been used to assess shoulder function, but it is unknown which are the most effective. Purpose/Hypothesis: The purpose of this study was to report the multiple PROMs used after rotator cuff repair (RCR) and to compare the responsiveness between them. It was hypothesized that the Western Ontario Rotator Cuff PROM would be the most responsive and commonly used in patients undergoing RCR. Study Design: Meta-analysis; Level of evidence, 4. Methods: A systematic review was conducted in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and PRISMA-Searching extension guidelines via PubMed/MEDLINE, Embase (Elsevier), and Web of Science (Clarivate). Patient and study characteristics were extracted. From the studies that met inclusion criteria for responsiveness analysis (≥2 PROMs reported, 1-year minimum follow-up, and pre- and postoperative PROM means and standard deviations reported), the authors compared the responsiveness between PROM instruments using effect size and relative efficiency (RE) if a PROM could be compared with another in ≥10 articles. Results: A total of 252 studies met inclusion criteria (32,072 patients; mean age, 59.6 years; mean body mass index, 28.7; mean follow-up time, 27.8 months). Range of motion was reported in 131 (52%) studies and imaging findings were reported in 123 (49%) studies. There were 67 PROM instruments identified; the most commonly used were the American Shoulder and Elbow Surgeon (ASES) (n = 183; 73%), Visual Analog Scale (VAS) (n = 163; 65%), and Constant (n = 118; 47%) scores. The 3 PROMs with the highest effect sizes were the University of California, Los Angeles (UCLA) (2.51), Western Ontario Rotator Cuff (2.42), and ASES (2.00) scores. Overall, UCLA and ASES scores were the most responsive PROMs. The ASES PROM was more responsive than the VAS (RE, 1.70), Constant (RE, 2.76), Simple Shoulder Test (RE, 1.67), and Single Assessment Numeric Evaluation (RE, 2.14) scores. The UCLA PROM was more responsive than the ASES (RE, 1.03), VAS (RE, 3.66), Constant (RE, 1.72), and Simple Shoulder Test (RE, 1.66) scores. Conclusion: ASES and UCLA scores were the most responsive PROMs after RCR. The authors recommend widespread adoption of ASES and UCLA scores for clinical and research standardization; however, the UCLA PROM requires in-person range of motion and strength testing, which is a practical limitation and barrier to long-term follow-up. [ABSTRACT FROM AUTHOR]

Purpose: Patients with urinary calculi undergo resource-intensive follow-up. Application of a PROM, Urinary Stones and Intervention Quality of Life (USIQoL), can potentially optimise current practices if it matches the outcomes of traditional follow-up. Our objective was to develop, and conduct, a preliminary validation of the USIQoL based prediction model to aid triage. Methods: We performed a two phase prospective cohort study. The 1st phase included development of the USIQoL-based decision model using multicentre data. The 2nd phase involved prospective single-blind external validation for the outpatient application. The aim was to evaluate correlations between the USIQoL scores and key predictors; clinical outcomes and global health ratings (EuroQoL EQ-5D). We used statistical analysis to validate USIQoL cut-off scores to aid triage and the decision to intervene. Results: Of 503 patients invited, 91% (n = 455, Development [305] and Validation [150]; M = 308, F = 147) participated. The relationship between USIQoL domain scores and clinical outcomes was consistently significant (estimated odds: PPH 1.24, p < 0.001, 95% CI 1.13–1.36; PSH 1.22, p < 0.001, 95% CI 1.12–1.33). The ROC values for the model were ≥ 0.75. The optimum domain cut-off scores were derived with rising scores implying increased need to intervene. The model demonstrated satisfactory sensitivity (0.81–0.89) and specificity (0.36–0.47). Conclusions: The study demonstrates satisfactory correlation between the USIQoL and clinical outcomes making this model a valid aid for triage and optimising outpatient management with the cut-off scores able to identify high risk patients who need active treatment. [ABSTRACT FROM AUTHOR]

This study aims to clarify the current concept of performing rhinoplasty in patients with possible body dysmorphic disorder (BDD). The primary objective was to investigate the validity and evolution over time of the Body Dysmorphic Disorder Questionnaire—Aesthetic Surgery (BDDQ-AS) before and after surgery. Together with the BDDQ-AS, also the Nasal Obstruction Symptom Evaluation scale, FACE-Q nose and nostrils, and Utrecht questionnaire (UQ) were used for convergent validation. In this prospective study, 187 patients completed these patient-reported outcome measures at four time points: at the preoperative consultation and postoperatively at 3, 6 and 12 months. The preoperative BDDQ-AS positivity rate was as high as 55.1%. Postoperatively, there was a highly significant decrease in the odds of scoring positive on the BDDQ-AS. At the preoperative consultation, positively screened patients were less satisfied with the esthetics of their noses with worse scores on UQ, FACE-Q nose, and visual analog scale. The preoperative differences in outcome measure ratings disappeared postoperatively, except for the FACE-Q nostrils, which surprisingly showed better values in BDDQ-AS positive patients. Younger age and absence of nasal trauma were statistically significant covariates associated with positive BDDQ-AS screening. Due to the overwhelming decrease in positive BDDQ-AS outcomes after surgery, a positive screening result on the BDDQ-AS should not be interpreted as a formal contraindication for surgery. Collaboration with psychologists or psychiatrists remains crucial to diagnose BDD conclusively. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to determine the psychometric properties of the Spanish-language version of the HIV-Symptom Index (HIV-SI) questionnaire in Spanish patients undergoing antiretroviral therapy. Methods: Between 2014 and 2016, an observational, multicenter, prospective cohort study was conducted in seventeen Spanish hospitals to validate HIV-SI questionnaire in terms of: construct validity (confirmatory factor analysis), internal consistency (Cronbach's alpha), convergent validity (Pearson's correlation coefficient) and Known-group validity. In addition, a sensitivity to change analysis was also performed. Results: A total of 232 patients were included in the study. They had a mean age of 46.17 (SD9.82) and were 75% male. The median overall score for the HIV-SI was 10 (IQR 4– 19.5) and the most common symptoms reported were feelings of nervousness or anxiety, fatigue or energy loss, feeling sad or depressed, stomach pain or bloating, and difficulty sleeping. In the current study, the Spanish HIV-SI questionnaire showed a high internal consistency (α = 0.89) and adequate construct validity (CFI and TLI > 0.90). When contrasted with the MOS-HIV questionnaire, an inverse correlation was found. It showed a good association with the mental (r=-0.61; P < 0.0001) and physical score (r=-0.60; P < 0.0001). In a multivariate analysis, the age of the patient, female condition, hepatitis C coinfection, concomitant treatment and non-adherence resulted in a higher HIV-SI score. Conclusions: Our study has shown that the Spanish HIV-SI is a valid and reliable self-administered PROM for routine measurement of patient- reported symptoms among Spanish patients on antiretroviral treatment. [ABSTRACT FROM AUTHOR]

ABSTRACT Aim Materials and Methods Results Conclusion Patient‐reported outcomes (PROs) hold significant potential in guiding clinical decision making, yet their utilization in periodontal trials has been limited. This systematic review aimed to critically synthesize and analyse qualitative studies that evaluated the knowledge and impact of periodontitis and its treatment on patients' lives, as well as their motivations, expectations and experiences in seeking treatment.Six databases were searched up to March 2024 for qualitative studies on periodontitis patients. Studies were quality‐assessed using the JBI Critical Appraisal and ConQual tools. Two authors independently extracted the findings, with discrepancies resolved by a third reviewer.Thirteen studies from 2006 to 2023 across four continents, involving 215 participants, identified five themes related to periodontitis: (i) knowledge about periodontitis and its treatment; (ii) impact of periodontitis on patients' lives; (iii) motivation and treatment expectations; (iv) obstacles to treatment; and (v) treatment impact on patients' lives.Significant physical and psychosocial impacts of periodontitis on patients' lives were identified, along with critical gaps in knowledge and awareness, emphasizing the important role of dentists in patient education. Specific PROs for use in validated instruments tailored to periodontitis were identified. These results can enhance patient‐centred care by guiding future studies in accurately assessing patient perspectives on their condition and treatment. [ABSTRACT FROM AUTHOR]

Introduction: Chronic Obstructive Pulmonary Disease (COPD) profoundly affects physical, psychological, and social aspects of life, yet these issues often remain unaddressed. Patient-Reported Outcomes Measures (PROM) have the potential to address these issues by promoting person-centered communication. However, their impact in COPD practice remains uncertain. This study aimed to investigate how patients with COPD perceive the usefulness of a new holistic PROM for general palliative care (PRO-Pall) before and during outpatient consultations. Methods: Semi-structured telephone interviews were conducted with patients diagnosed with moderate to very severe COPD, 2-5 days after consultation at a respiratory outpatient clinic in Denmark. Interviews were transcribed verbatim and analyzed inductively using qualitative content analysis. Results: Nine patients (five males; mean age: 66 years) participated in the study with four themes emerging: (1) Unlocking thoughts: Completing PRO-Pall stimulated patients’ self-reflection, which revealed previously overlooked COPD-related issues, particularly psychosocial challenges. (2) Unmasking concerns: Patients felt encouraged to be honest, rather than concealing their concerns. (3) Breaking the ice: PRO-Pall responses enabled direct questioning by healthcare professionals during consultations, initiating discussions on patients’ sensitive yet vital COPD-related matters. (4) Deepening the dialogue: Healthcare professionals’ targeted and attentive approach fostered more holistic and meaningful discussions, providing most patients with a deeper understanding of psychosocial issues affecting their well-being. Conclusion: Completing PRO-Pall prior to outpatient consultations prompted most patients with COPD to unveil previously unacknowledged psychosocial challenges. During consultations, addressing these challenges initiated open discussions on individual concerns, enhancing most patients’ understanding of the multifaceted burden of COPD. [ABSTRACT FROM AUTHOR]

Background: Multiple sclerosis (MS) is a chronic neurological condition and the leading cause of non-traumatic disability in young adults. MS pathogenesis leads to the death of oligodendrocytes, demyelination, and progressive central nervous system neurodegeneration. Endogenous remyelination occurs in people with MS (PwMS) but is insufficient to repair the damage. Our preclinical studies in mice indicate that endogenous remyelination can be supported by the delivery of repetitive transcranial magnetic stimulation (rTMS). Our phase I trial concluded that 20 sessions of rTMS, delivered over 5 weeks, are safe and feasible for PwMS. This phase II trial aims to investigate the safety and preliminary efficacy of rTMS for PwMS. Methods: Participants must be aged 18–65 years, diagnosed with MS by a neurologist, stable and relapse free for 6 months, have an Extended Disability Status Scale (EDSS) between 1.5 and 6 (inclusive), willing to travel to a study site every weekday for 4 consecutive weeks, and able to provide informed consent and access the internet. Participants from multiple centres will be randomised 2:1 (rTMS to sham) stratified by sex. The intervention will be delivered with a Magstim Rapid2 stimulator device and circular 90-mm coil or MagVenture MagPro stimulator device with C100 circular coil, positioned to stimulate a broad area including frontal and parietal cortices. For the rTMS group, pulse intensity will be set at 18% (MagVenture) or 25% (Magstim) of maximum stimulator output (MSO), and rTMS applied as intermittent theta burst stimulation (iTBS) (~ 3 min per side; 600 pulses). For the sham group, the procedure will be the same, but the intensity is set at 0%. Each participant will attend 20 intervention sessions over a maximum of 5 weeks. Outcome measures include MS Functional Composite Score (primary), Fatigue Severity Scale, Hospital Anxiety and Depression Scale, Quality of Life, and Pittsburgh Sleep Quality Index/Numeric Rating Scale and adverse events (secondary) and advanced MRI metrics (tertiary). Outcomes will be measured at baseline and after completing the intervention. Discussion: This study will determine if rTMS can improve functional outcomes or other MS symptoms and determine whether rTMS has the potential to promote remyelination in PwMS. Trial registration: Registered with Australian New Zealand Clinical Trials Registry, 20 January 2022; ACTRN12622000064707. [ABSTRACT FROM AUTHOR]

Background: Premature rupture of the membranes (PROM) is a key cause of preterm birth and represents a major cause of neonatal mortality and morbidity. Natural products N-acetyl-d-galactosamine (GalNAc), which are basic building blocks of important polysaccharides in biological cells or tissues, such as chitin, glycoproteins, and glycolipids, may improve possible effects of wound healing. Methods: An in vitro inflammation and oxidative stress model was constructed using tumor necrosis-α (TNF-α) and lipopolysaccharide (LPS) action on WISH cells. Human amniotic epithelial cells (hAECs) were primarily cultured by digestion to construct a wound model. The effects of GalNAc on anti-inflammatory and anti-oxidative stress, migration and proliferation, epithelial-mesenchymal transition (EMT), glycosaminoglycan (GAG)/hyaluronic acid (HA) production, and protein kinase B (Akt) pathway in hAECs and WISH cells were analyzed using the DCFH-DA fluorescent probe, ELISA, CCK-8, scratch, transwell migration, and western blot to determine the mechanism by which GalNAc promotes amniotic wound healing. Results: GalNAc decreased IL-6 expression in TNF-α-stimulated WISH cells and ROS expression in LPS-stimulated WISH cells (P < 0.05). GalNAc promoted the expression of Gal-1 and Gal-3 with anti-inflammatory and anti-oxidative stress effects. GalNAc promoted the migration of hAECs (50% vs. 80%) and WISH cells through the Akt signaling pathway, EMT reached the point of promoting fetal membrane healing, and GalNAc did not affect the activity of hAECs and WISH cells (P > 0.05). GalNAc upregulated the expression of sGAG in WISH cells (P < 0.05) but did not affect HA levels (P > 0.05). Conclusions: GalNAc might be a potential target for the prevention and treatment of PROM through the galectin pathway, including (i) inflammation; (ii) epithelial-mesenchymal transition; (iii) proliferation and migration; and (iv) regression, remodeling, and healing. [ABSTRACT FROM AUTHOR]

Background Twin pregnancy is the most common multiple gestation in clinical practice. Timely management by specialist and improvement in neonatal care facilities improve the outcome of twin pregnancy. Studies show that the risk of miscarriage, preeclampsia, polyhydramnios, preterm labor, abnormal vascular communication, fetal malformation, discordant fetal growth, cord complications, still birth, increased rate of cesarean section, abnormal iron and folic acid deficiency anemia, postpartum hemorrhage and maternal death were higher in multifetal pregnancy compared to singleton pregnancy. In this study we wanted to evaluate the fetomaternal outcome in twin pregnancy. Methods This cross-sectional study was carried out in the Department of Obstetrics & Gynaecology, RIMS (Regional Institute of Medical Sciences), Imphal. This study was conducted on all the cases of twin pregnancies admitted in the Department of Obstetrics & Gynaecology, RIMS, Imphal. All eligible participants were selected consecutively. History and clinical examination, along with obstetric and fetal parameters, were recorded. Results After adjusting for factors, the result shows that compared to primiparous mothers, mothers with parity 1 and 2 or more were 79 and 94 percent less likely to give birth to both twins with low birthweight, respectively, and the difference was found to be statistically significant (p = 0.020 and 0.001). Conclusions The most common maternal complications of twin pregnancy are hyperemesis gravidarum, preterm labor, hypertensive disorder, and PROM. While observing the adverse outcomes, the risk factors that had a significant effect on preterm birth and low birth weight were booking status, literacy, parity, type of placenta, presentation of fetuses, preterm labor and the presence of polyhydramnios. [ABSTRACT FROM AUTHOR]

Objectives To evaluate 1-year bimekizumab efficacy in PsA from the patient perspective using the 12-item PsA Impact of Disease (PsAID-12) questionnaire. Methods BE OPTIMAL (NCT03895203; biologic DMARD [bDMARD]-naïve), BE COMPLETE (NCT03896581; inadequate response/intolerance to TNF inhibitors [TNFi-IR]) and BE VITAL (NCT04009499; open-label extension) assessed bimekizumab 160 mg every 4 weeks in patients with PsA. Post hoc analyses of patient-reported disease impact, assessed by the PsAID-12 questionnaire, are reported to 1 year (collected to Week 40 in BE COMPLETE). Results Overall, 1,112 total patients were included (698 bimekizumab, 414 placebo). Rapid improvements observed with bimekizumab treatment at Week 4 continued to Week 16 and were sustained to 1 year. At 1 year, mean (SE) change from baseline in PsAID-12 total score was comparable between bimekizumab-randomized patients and patients who switched to bimekizumab at Week 16 (bDMARD-naïve bimekizumab –2.3 [0.1], placebo/bimekizumab –2.2 [0.1]; TNFi-IR bimekizumab –2.5 [0.1], placebo/bimekizumab –2.2 [0.2]). Proportions of bimekizumab-randomized patients achieving clinically meaningful within-patient improvement (≥3-point decrease from baseline) at Week 16 were sustained to 1 year (bDMARD-naïve 49.0%; TNFi-IR 48.5%) and were similar for placebo/bimekizumab patients (bDMARD-naïve 44.4%; TNFi-IR 40.6%). Across studies and arms, 35.3% to 47.8% of patients had minimal or no symptom impact at 1 year. Improvements were observed to 1 year across all single-item domains, including pain, fatigue and skin problems. Conclusion Bimekizumab treatment resulted in rapid and sustained clinically meaningful improvements in disease impact up to 1 year in bDMARD-naïve and TNFi-IR patients with PsA. Trial registration BE OPTIMAL: NCT03895203; BE COMPLETE: NCT03896581; BE VITAL: NCT04009499 (ClinicalTrials.gov) [ABSTRACT FROM AUTHOR]

Aim: Recently, efforts have been made to use and report person‐reported outcomes (PROs) in randomised clinical trials (RCTs). Here, we aim to (1) assess the status of inclusion of PROs in registered RCTs over 5 years in people with type 1 or 2 diabetes, and (2) map the PRO measures (PROMs) onto predefined domains. Methods: The largest trial registries (Clinicatrials.gov, International Clinical Trial Platform and ISRCTN) were systematically searched for RCTs in people with type 1 and/or type 2 diabetes of all ages between 2018 and 2023. Coding of PROs comprised: (1) PRO measure(s) included yes or no; if yes: (2) PRO(s) as primary outcome yes or no; and (3) mapping PROMs onto predefined PRO domains and per type of intervention. Results: N = 1543 trials met our inclusion criteria, of which n = 673 (44%) included PROs, assessed by 545 different measures. Twenty per cent of drug trials (n = 112) and 71% of behavioural interventions (n = 405) included PROs. In 149 trials (9.6%), a PRO was the primary outcome. The psychological functioning domain was most often assessed across all trials (21.6%), specifically in behavioural (44.8%) and medical device interventions (29.7%). In drug trials, the physical functioning and functional health domain was most included (9%). Across all trials, the social and family functioning domain was least assessed (3%). Conclusions: We noticed an increase in the inclusion of PROs in diabetes RCTs. However, PROs are rarely included as primary outcomes in the majority of studies, particularly in drug trials. The heterogeneity of PROMs used in RCTs underscores the need for standardisation of PROs. [ABSTRACT FROM AUTHOR]

Objective: To investigate the initial set of patient-reported outcomes (PROs) in the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) and their associations with 30-day surgical outcomes. Background: PROs provide important information that can be used to improve routine care and facilitate quality improvement. The American College of Surgeons conducted a demonstration project to capture PROs into the NSQIP to complement clinical data. Methods: From February 2020 to March 2023, 65 hospitals collected Patient-Reported Outcomes Measurement Information System measures assessing global health, pain interference, fatigue, and physical function from patients accrued into the NSQIP. Using multivariable mixed regression, we compared the scores of patients with and without 30-day complications and further analyzed scores exceeding 1-SD worse than national benchmarks. Results: Overall, 33842 patients completed the Patient-Reported Outcomes Measurement Information System measures with a median of 58 days (IQR: 47-72) postoperatively. Among patients without complications (n = 31210), 33.9% had PRO scores 1-SD worse than national benchmarks. Patients with complications were 1.7 times more likely to report worse PROs (95% CI: 1.6-1.8). Patients with complications had lower scores for global physical health [adjusted mean difference (AMD): 2.6, 95% CI: 2.2-3.0], lower for global mental health (AMD: 1.8, 95% CI: 1.4-2.2), higher for pain interference (AMD: 2.4, 95% CI: 2.0-2.8), higher fatigue (AMD: 2.7, 95% CI: 2.3-3.1), and lower physical function (AMD: 3.2, 95% CI: 2.8-3.5). Conclusions: Postoperative complications negatively affect multiple key dimensions of patients' health-related quality of life. PROs were well below national benchmarks for many patients, even among those without complications. Identifying solutions to improve PROs after surgery remains a tremendous quality improvement opportunity. [ABSTRACT FROM AUTHOR]

To determine, in patients undergoing total knee arthroplasty (TKA), whether increasing context specificity of selected items of the shortened version of the Western Ontario and McMaster Universities Osteoarthritis Index function (WOMAC-F) scale (ShortMAC-F) (1) enhanced the convergent validity of the ShortMAC-F with performance-based mobility measures (ii) affected mean scale score, structural validity, reliability, and interpretability. Secondary analysis of randomized clinical trial data. A tertiary teaching hospital. Patients undergoing TKA (N=114). Not applicable. The ShortMAC-F was modified by specifying the "ascending stairs" and "rising from sitting" items to enquire about difficulty in performing the tasks without reliance on compensatory strategies, whereas the modified "level walking" item enquired about difficulty in walking 400 m. Before and 12 weeks after TKA, patients completed the WOMAC-F questionnaire, modified ShortMAC-F questionnaire, knee pain scale questionnaire, sit-to-stand test, fast gait speed test, and stair climb test. Interpretability was evaluated by calculating anchor-based substantial clinical benefit estimates. The modified ShortMAC-F correlated significantly more strongly than ShortMAC-F or WOMAC-F with pooled performance measures (differences in correlation values, 0.12-0.14). Increasing item context specificity of the ShortMAC-F did not influence its psychometric properties of unidimensionality (comparative fit and Tucker–Lewis indices, >0.95; root mean square error of approximation, 0.05-0.08), reliability (Cronbach's α, 0.75-0.83), correlation with pain intensity (correlation values, 0.48-0.52), and substantial clinical benefit estimates (16 percentage points); however, it resulted in lower mean score (4.5-4.8 points lower). The modified ShortMAC-F showed sufficient measurement properties for clinical application, and it seemed more adept than WOMAC-F at correlating with performance-based measures in TKA. [ABSTRACT FROM AUTHOR]

BACKGROUND: Social media data may augment understanding of the disease and treatment experiences and quality of life of youth with chronic medical conditions. Little is known about the willingness to share social media data for health research among youth with chronic medical conditions and the differences in health status between sharing and nonsharing youth with chronic medical conditions. OBJECTIVE: We aimed to evaluate the associations between patient-reported measures of disease symptoms and functioning and the willingness to share social media data. METHODS: Between February 2018 and August 2019, during routine clinic visits, survey data about social media use and the willingness to share social media data (dependent variable) were collected from adolescents in a national rheumatic disease registry. Survey data were analyzed with patient-reported measures of disease symptoms and functioning and a clinical measure of disease activity, which were collected through a parent study. We used descriptive statistics and multivariate logistic regression to compare patient-reported outcomes between youth with chronic medical conditions who opted to share social media data and those who did not opt to share such data. RESULTS: Among 112 youths, (age: mean 16.1, SD 1.6 y; female: n=72, 64.3%), 83 (74.1%) agreed to share social media data. Female participants were more likely to share (P=.04). In all, 49 (43.8%) and 28 (25%) participants viewed and posted about rheumatic disease, respectively. Compared to nonsharers, sharers reported lower mobility (T-score: mean 49.0, SD 9.4 vs mean 53.9, SD 8.9; P=.02) and more pain interference (T-score: mean 45.7, SD 8.8 vs mean 40.4, SD 8.0; P=.005), fatigue (T-score: mean 49.1, SD 11.0 vs mean 39.7, SD 9.7; P

Abstract Background With over 65,000 new cases per year in Germany, prostate cancer (PC) is the most common cancer in men in Germany. Localized PC is often treated by radical prostatectomy and has a very good prognosis. Postoperative quality of life (QoL) is significantly influenced by the side effects of surgery. One possible approach to improve QoL is postoperative symptom monitoring using ePROMs (electronic patient-reported outcome measures) to accurately identify any need for support. Methods The PRO-P (“Influence of ePROMS in surgical therapy of PC on the postoperative course”) study is a randomized controlled trial employing 1:1 randomization at 6 weeks postoperatively, involving 260 patients with incontinence (≥ 1 pad/day) at six participating centers. Recruitment is planned for 1 year with subsequent 1-year follow-up. PRO-monitoring using domains of EPIC-26, psychological burden, and QoL are assessed 6, 12, 18, 24, 36, and 52 weeks postoperatively. Exceeding predefined PRO-score cutoffs triggers an alert at the center, prompting patient contact, medical consultation, and potential interventions. The primary endpoint is urinary continence. Secondary endpoints refer to EPIC-26 domains, psychological distress, and QoL. Aspects of feasibility, effect, and implementation of the intervention will be investigated within the framework of a qualitative process evaluation. Discussion PRO-P investigates the effect on postoperative symptom monitoring of a structured follow-up using ePROMs in the first year after prostatectomy. It is one of the first studies in cancer surgery investigating PRO-monitoring and its putative applicability to routine care. Patient experiences with intensified monitoring of postoperative symptoms and reflective counseling will be examined in order to improve primarily urinary continence, and secondly other burdens of physical and psychological symptoms, quality-of-life, and patient competence. The potential applicability of the intervention in clinical practice is facilitated by IT adaption to the certification standards of the German Cancer Society and the integration of the ePROMs survey via a joint patient portal. Positive outcomes could readily translate this complex intervention into routine clinical care. PRO-P might improve urinary incontinence and QoL in patients with radical prostatectomy through the structured use of ePROMs. Trial registration ClinicalTrials.gov NCT05644821. Registered on 09 December 2022.

In Deutschland ist der aktuelle Stand der Nutzung von Patient-Reported Outcome Measures (PROM) und Patient-Reported Experience Measures (PREM) ausbaufähig. Derzeit erfolgt hierzulande die Anwendung dieser Instrumente eher noch in einem fragmentierten und unkoordinierten Rahmen (1). Der Grund: Es fehlt an einer flächendeckenden und systematischen Implementierung, die auf der Metaebene zu einer stärkeren Ergebnisorientierung im deutschen Gesundheitswesen (2) beitragen könnte oder auf der Systemebene in der Lage wäre, realistischere und evidenzbasierte Endpunkte zum Beispiel in „besonderen Therapiesituationen“ zu generieren. Der 13. Fachkongress von „Monitor Versorgungsforschung“ widmet sich diesem Themenkomplex unter dem Titel „Mit PROM und PREM zu Patient Centered Care“: Startpunkt eines möglichen Umdenkens.

Abstract Objective The objective of this study was to measure and describe the national patient experience of radical cystectomy (RC) pathways in the UK using the validated Cystectomy‐Pathway Assessment Tool (C‐PAT). Patients and Methods A cohort of 1081 patients who underwent RC for bladder cancer, between 1 January 2021 and 31 July 2022 at 33 UK cystectomy centres, returned completed C‐PAT responses. SPSS was employed for data summary statistics, including median, interquartile range, Mann Whitney U test or Chi‐square test with a 95% confidence interval to assess statistical significance between potentially associated variables. Open‐text responses in the C‐PAT tool were analysed and coded using NVivo software. Results In this cohort, the greatest perceived delay in the RC pathway, reported by 19% of patients (n = 208), was at the GP consultation to first hospital referral stage with suspected bladder cancer. Around 10% of patients perceived delays at each of the other stages in their pathway. Cancer nurse specialist (CNS) contact was strongly associated with an improved patient experience (p

Purpose: The outcome after a distal radius fracture (DRF) is often evaluated with radiography, clinical examination, and patient-reported outcome measures. However, research has identified associations between psychological factors and outcomes after a DRF. A knowledge gap exists about psychological factors and their potential implications for long-term outcomes after a DRF. The aim of this study was to examine the long-term association between psychological factors and patient-reported outcomes. Methods: This multicenter investigation included patients aged 15–75 years with closed physes presenting with an acute DRF. Patients who completed a long-term follow-up (after 11–13 years) with patient-reported outcome measures were invited to participate in the study, and surveys measuring psychological factors were sent to the patients. Results: Two hundred and four patients (70%) completed the follow-up (mean [range] age at injury, 56 [18–75] years; 154 were females [75%]). Multivariable analysis showed that higher age, injury to the dominant hand, and greater pain catastrophizing were associated with an increase in scores on the Disabilities of the Arm, Shoulder, and Hand questionnaire. Conclusions: A decade after sustaining a DRF, patients with higher scores on the Pain Catastrophizing Scale reported inferior outcomes as measured by the Disabilities of the Arm, Shoulder, and Hand. The Pain Catastrophizing Scale accounts for 13% of the observed variance in Disabilities of the Arm, Shoulder, and Hand. Type of study/level of evidence: Therapeutic level IIb.

Abstract Background Multiple sclerosis (MS) is a chronic neurological condition and the leading cause of non-traumatic disability in young adults. MS pathogenesis leads to the death of oligodendrocytes, demyelination, and progressive central nervous system neurodegeneration. Endogenous remyelination occurs in people with MS (PwMS) but is insufficient to repair the damage. Our preclinical studies in mice indicate that endogenous remyelination can be supported by the delivery of repetitive transcranial magnetic stimulation (rTMS). Our phase I trial concluded that 20 sessions of rTMS, delivered over 5 weeks, are safe and feasible for PwMS. This phase II trial aims to investigate the safety and preliminary efficacy of rTMS for PwMS. Methods Participants must be aged 18–65 years, diagnosed with MS by a neurologist, stable and relapse free for 6 months, have an Extended Disability Status Scale (EDSS) between 1.5 and 6 (inclusive), willing to travel to a study site every weekday for 4 consecutive weeks, and able to provide informed consent and access the internet. Participants from multiple centres will be randomised 2:1 (rTMS to sham) stratified by sex. The intervention will be delivered with a Magstim Rapid2 stimulator device and circular 90-mm coil or MagVenture MagPro stimulator device with C100 circular coil, positioned to stimulate a broad area including frontal and parietal cortices. For the rTMS group, pulse intensity will be set at 18% (MagVenture) or 25% (Magstim) of maximum stimulator output (MSO), and rTMS applied as intermittent theta burst stimulation (iTBS) (~ 3 min per side; 600 pulses). For the sham group, the procedure will be the same, but the intensity is set at 0%. Each participant will attend 20 intervention sessions over a maximum of 5 weeks. Outcome measures include MS Functional Composite Score (primary), Fatigue Severity Scale, Hospital Anxiety and Depression Scale, Quality of Life, and Pittsburgh Sleep Quality Index/Numeric Rating Scale and adverse events (secondary) and advanced MRI metrics (tertiary). Outcomes will be measured at baseline and after completing the intervention. Discussion This study will determine if rTMS can improve functional outcomes or other MS symptoms and determine whether rTMS has the potential to promote remyelination in PwMS. Trial registration Registered with Australian New Zealand Clinical Trials Registry, 20 January 2022; ACTRN12622000064707.

Abstract Background Premature rupture of the membranes (PROM) is a key cause of preterm birth and represents a major cause of neonatal mortality and morbidity. Natural products N-acetyl-d-galactosamine (GalNAc), which are basic building blocks of important polysaccharides in biological cells or tissues, such as chitin, glycoproteins, and glycolipids, may improve possible effects of wound healing. Methods An in vitro inflammation and oxidative stress model was constructed using tumor necrosis-α (TNF-α) and lipopolysaccharide (LPS) action on WISH cells. Human amniotic epithelial cells (hAECs) were primarily cultured by digestion to construct a wound model. The effects of GalNAc on anti-inflammatory and anti-oxidative stress, migration and proliferation, epithelial-mesenchymal transition (EMT), glycosaminoglycan (GAG)/hyaluronic acid (HA) production, and protein kinase B (Akt) pathway in hAECs and WISH cells were analyzed using the DCFH-DA fluorescent probe, ELISA, CCK-8, scratch, transwell migration, and western blot to determine the mechanism by which GalNAc promotes amniotic wound healing. Results GalNAc decreased IL-6 expression in TNF-α-stimulated WISH cells and ROS expression in LPS-stimulated WISH cells (P 0.05). GalNAc upregulated the expression of sGAG in WISH cells (P 0.05). Conclusions GalNAc might be a potential target for the prevention and treatment of PROM through the galectin pathway, including (i) inflammation; (ii) epithelial-mesenchymal transition; (iii) proliferation and migration; and (iv) regression, remodeling, and healing.

Domantas Stundys,1,&ast; Alvija Ku&ccaron;inskait&edot;,2,&ast; Simona Gervickait&edot;,3 Gabriel&edot; Tarutyt&edot;,4– 6 J&umacr;rat&edot; Grigaitien&edot;,1 Janina Tutkuviene,3 Ligita Jan&ccaron;orien&edot;1 1Vilnius University, Faculty of Medicine, Institute of Clinical Medicine, Vilnius, 03101, Lithuania; 2Vilnius University, Faculty of Medicine, Vilnius, 03101, Lithuania; 3Vilnius University, Faculty of Medicine, Department of Anatomy, Histology and Anthropology, Vilnius, 03101, Lithuania; 4Vilnius University, Faculty of Medicine, Department of Research and Innovation, Vilnius, 03101, Lithuania; 5Vilnius University, Faculty of Mathematics and Informatics, Institute of Applied Mathematics, Vilnius, 03225, Lithuania; 6Vilnius University Hospital Santaros Klinikos, Vilnius, 08661, Lithuania&ast;These authors contributed equally to this workCorrespondence: Domantas Stundys, Centre of Dermatovenereology, Vilnius University Hospital Santaros Klinikos, Santariški&uogon; g. 2, Vilnius, Lithuania, Tel +370 5 236 5000, Email domantas.stundys@santa.ltPurpose: Facial basal cell carcinoma (BCC) poses significant challenges due to its potential for local destruction and impact on quality of life (QoL). Continuous research is necessary to identify novel factors influencing the quality of life within this demographic across diverse cultural settings. The aims of this study were to translate, culturally adapt, and validate the Lithuanian version of Skin Cancer Index, subsequently utilizing this questionnaire in the pilot phase of the study to achieve the following: (1) identify the differences in short- and long-term QoL, (2) establish empirical correlations between SCI scores and aesthetic facial regions, evaluate the potential differences between age, gender, and tumor size groups.Patients and Methods: A prospective longitudinal study was conducted with 100 consecutive patients. The SCI was translated into Lithuanian language, with a rigorous assessment of its psychometric properties to confirm validity. Alongside hypothesis testing, a detailed analysis of variables was conducted. Statistical techniques, including t-tests and ANOVA, were employed to compare scores across demographic and clinical groups, with effect size calculations for further interpretation.Results: Our findings demonstrate that the Lithuanian SCI successfully fulfills the criteria established by the COSMIN checklist. Surgical treatment for facial BCC notably enhances QoL, particularly evident six months post-surgery. Analysis of SCI scores identified demographic and clinical factors associated with lower QoL, including female gender, treatment with skin plasty, and tumor sites in aesthetically sensitive areas like the cheek, nose, and eyelid.Conclusion: The Lithuanian version of the SCI is a reliable and valid tool for assessing QoL in facial BCC patients. Our findings underscore the global relevance of understanding the multifactorial influences on QoL in BCC patients. Early diagnosis, less invasive treatment approaches, and tailored post-operative care are crucial in minimizing the psychological, social, and appearance-related burdens of facial BCC.Keywords: skin cancer, face surgery, outcomes, skin cancer surgery, health-related quality of life, PROM

Abstract Background Patient-reported outcome measures quantify outcomes from patients’ perspective with validated instruments. QuickDASH (Quick Disability of Arm, Shoulder and Hand, an upper extremity PROM) scores improve after completing instrument tasks, suggesting patient-reported outcome results can be modified. We hypothesized that performing lower extremity tasks on the knee injury and osteoarthritis outcome score for joint reconstruction (KOOS-JR) and hip disability and osteoarthritis outcome score for joint reconstruction (HOOS-JR) instruments would similarly improve the scores. Methods Forty seven hip and 62 knee osteoarthritis patients presenting to a suburban academic center outpatient osteoarthritis and joint replacement clinic were enrolled and randomized to an intervention or a control group. Inclusion criteria were age over 18 years and English competency. Patients completed a HOOS-JR or KOOS-JR instrument, completed tasks similar to those of the instrument (intervention) or the QuickDASH (control), and then repeated instruments again. Paired and unpaired t-tests were used to compare the intervention and control group scores before and after tasks. Results There was no significant difference in total or individual scores after task completion compared to baseline in either the HOOS-JR or the KOOS-JR groups. There was no significant difference in the scores between the intervention or control groups. Conclusions Disability may be less modifiable in the lower extremity than in the upper extremity, perhaps because upper extremity activities are more easily compensated by the contralateral limb, or because lower extremity activities are more frequent. Thorough evaluation of factors influencing patient-reported outcome measures is necessary before their extensive application to quality control and reimbursement models.

Purpose: To assess the patient-reported outcome measures and health-related quality of life in cataract patients after their cataract surgery. Method: A prospective observational pilot study was conducted on 197 patients with cataract who underwent phacoemulsification cataract surgery in an urban-based eye care hospital. Result: Out of 197 patients, 110 patients fulfilled the inclusion criteria of the study. In our study, we chose Catquest-9SF as our parent questionnaire and made a few modifications in it based on the livelihood of our patients. The patient satisfaction percentage with reference to improvement in vision after cataract surgery with intraocular lens (IOL) implantation in our study was 87%. A total of 96% of the patients who had multifocal/trifocal IOL implantation were completely satisfied with the cataract surgery. Conclusion: Due to improvement in life expectancy of elderly patients and increased usage of gadgets by them, spectacle independence and functional improvement have become their requirements. With standardised techniques, expertise and experience with the right use of advanced equipment and appropriate IOLs, we were able to get excellent results and complete patient satisfaction by knowing their lifestyle and requirement. Patient-reported outcome measures helped us in improving the vision and health-related quality of life after cataract surgery.

Abstract Background Revision total hip arthroplasties (RTHA) are associated with a higher complication rate than primary total hip arthroplasties (THA), and therefore it is important for patients to have realistic expectations regarding outcomes. The aim of this literature review was to gather and summarize the available evidence on patients’ expectations following RTHA. Methods A literature search was conducted in PubMed, PsycINFO, Cochrane, Google Scholar, Web of Science and Embase from inception to November 2023. Articles assessing patient expectations for RTHA were included. Methodological quality was assessed by two independent reviewers using the National Heart, Lung and Blood Institute (NIH) study quality assessment tool for observational cohort and cross-sectional studies. A qualitative analysis was performed involving the summarization of study characteristics and outcomes. Results The search strategy generated 7,450 references, of which 5 articles met the inclusion criteria. Methodological quality scores ranged from 7–10. Patients had high expectations concerning future walking ability, pain and implant longevity relative to actual postoperative outcomes. A significant positive correlation was found between fulfilled expectations of pain and walking ability and patient satisfaction (r = 0.46–0.47). Only two studies assessed the fulfillment of patient expectations. Great variability was seen in the measurement of expectations. Conclusion Patients undergoing RTHA appeared to have high expectations for pain and functionality compared to postoperative outcomes. However, there was a paucity of high-quality data in this area, limiting the accuracy of the conclusion. Further research is needed, that emphasizes developing a sound theoretical framework for expectations, allowing for the consistent implementation of valid measurement tools for patient expectations.

Objective Materials and Methods Results Conclusions The SafetyCrown workflow facilitates the immediate restoration of posterior single sites with the one‐abutment/one‐time concept. This randomized clinical trial aimed to assess the direct effect of immediate restoration on dental patient‐reported outcomes (dPROs), feasibility, implant accuracy, and time.Participants with a single posterior edentulous site for late implant placement underwent optical impressions, shade selection, and cone beam computed tomography. After virtual treatment planning, they were randomized into the test group and the control group. For the test group, individual definitive hybrid abutments were prefabricated. The next step was a fully guided surgery with printed guides. After the implant was placed using guided surgery, the abutment was inserted. A chairside CAD/CAM workflow was used to provide the patient with a provisional restoration. Implants in the control group were left submerged to heal. Oral health‐related quality of life (OHRQoL) was assessed using the OHIP‐G14, and dPRO was measured using a 10‐item visual analog scale (VAS) questionnaire. Additional measurements of implant accuracy and time were performed. Follow‐up was performed 7 to 10 days after implant placement.Thirty‐nine participants with 45 restorations were included (test group: 23, control: 22). Immediate restoration was successful in 21 out of 23 implants (91.3%) in the test group. Both groups exhibited decreased OHRQoL without significant intergroup differences, while patient satisfaction was high overall. Test group participants perceived higher benefits and satisfaction with immediate loading than participants in the control group. Implant accuracy averaged 0.60 mm at the shoulder and 0.95 mm at the apex. Operative time was longer in the immediate loading group (61.9 min) than in the control group (32.1 min) (p < 0.001).Considering the limitations, the immediate restoration of late placed posterior implants using the described workflow proved feasible in 21 out of 23 cases. Both groups achieved high patient satisfaction with no differences in OHRQoL during the first week. Patients who received immediate loading rated the benefits very highly and were satisfied with the provisional restoration during the healing period. [ABSTRACT FROM AUTHOR]

Purpose: With a lack of standardization among outcome measures in fracture literature, cross-study comparisons remain limited. This systematic review aimed to identify trends in outcome measures reported by studies of the treatment of humeral shaft fractures. Methods: A systematic review was performed of studies reporting clinical outcomes of humeral shaft fractures indexed in PubMed. Extracted data included demographics, fracture characteristics, treatment modalities, outcomes, patient reported outcome measures (PROMs), and journal characteristics. Cochran-Armitage tests and linear regressions were used to identify data trends. Pearson chi-square and Kruskal–Wallis tests were used for comparisons between studies. Results: This review included 197 studies with outcomes of 15,445 humeral shaft fractures. 126 studies reported PROMs and 37 different PROMs were used. The Constant Score was most commonly reported (34% of studies), followed by ASES Score (21%), MEPS (21%), and DASH Score (20%). There was a significant increase in PROM usage over time (p = 0.016) and in articles using three or more PROMs (p = 0.005). The number of PROMs were significantly greater in prospective cohort studies and RCTs (p = 0.012) compared to retrospective cohort studies and case series (p = 0.044 for both). Post-treatment shoulder motion was reported in 43% of studies and 34% reported elbow motion. 86% of studies reported complications as an outcome parameter. Time to union and nonunion rate were published in 69% and 88% of studies, respectively. Conclusion: This study identified increasing PROM usage over time and disparities in the reporting of outcomes in humeral shaft fracture literature requiring further validation and standardization of available outcome measures. [ABSTRACT FROM AUTHOR]

Major burn injury, despite advancements in care and prevention, can have a profound impact on long-term morbidity, affecting quality of life and socioeconomic standing. We aim to explore factors predicting recovery of independence, the expected rate and time in majorly burned patients, and the measures of progress used. A systematic search of four databases (MEDLINE, EMBASE, COCHRANE, CINAHL) was conducted for studies reporting outcomes pertaining to physical ability indicative of independent function in adult (>15 y) cohorts who had suffered a major burn (>20% TBSA) up to 30 years after treatment in a developed specialised burn service. Data extracted included factors affecting rate of and time to achievement of function in five independence domains, as well as the outcome measures used. 21 eligible studies were included comprising 1298 major burns survivors with a combined mean age of 39.6 y and a mean TBSA of 25.8%. The most significant recurring factors impacting recovery of independent function were older age, female gender, burn severity, prolonged ICU and hospital admission, preceding mental health conditions, and post-acute psychological issues. Exercise-based rehabilitation conferred benefits on major burn patients even over 2 years following injury. Discharge to independent living from hospital occurred in 27% to 97% of patients, while reported return to work rates varied from 52% to 80%. Burns Specific Health Scale-Brief, Functional Independence Measure, and Physical Composite Score (SF-36) were the most widely used outcome scoring systems. Major burn survivors have protracted recovery with potential for persistent chronic impairments, remaining consistently below baseline levels of function. Non-modifiable factors such as age and gender, and disease characteristics such as burn size with associated physical, physiological and psychosocial sequelae are contributory. Further research is required to explore achievement of specific milestones of major burn and polytrauma critical care patients, while early targeted rehabilitation addressing physical, psychological, and vocational needs has promising potential benefit. • Survivors of severe burns persistently remain below baseline levels of function. • Many do not return to independent living or work, exacting a socioeconomic burden. • Older, female, and mental health patients may be less likely to regain independence. • Higher burn size/depth and prolonged admission are also significant risk factors. • Early physical & vocational rehabilitation with psychological support aids recovery. [ABSTRACT FROM AUTHOR]

Purpose: The Q1.6 Inguinal Hernia application continuously measures patient-reported outcomes (PROs) by sampling experiences through brief, digital and condition-specific questions, utilising micro-moments. This can overcome the limitations of current paper questionnaires and give real-time insight into patient recovery. This exploratory study compares data from the application with retrospective data from electronic medical records (EMRs) to provide information on its accuracy in detecting postoperative complications after inguinal hernia repair. Methods: Patients were asked to use the application in addition to their usual care. The application employs twitch crowdsourcing to gather PROs. Questions from validated and frequently used questionnaires were integrated. A retrospective assessment of EMRs was combined with an additional telephone interview. The primary endpoints were the sensitivity and specificity of the application in detecting chronic postoperative inguinal pain, recurrence and surgical-site infection (SSI). Results: A total of 215 patients were analysed. The sensitivity and specificity for detecting chronic postoperative inguinal pain were 100% (95% CI [47.8%, 100%]) and 93.7% (95% CI [88.3%, 97.1%]), respectively. For recurrence, the sensitivity was 77.8% (95% CI [40.0%, 97.2%]), and the specificity was 81.3% (95% CI [75.0%, 86.5%]). For SSI, the sensitivity and specificity were 75.0% (95% CI [19.4%, 99.4%]) and 89.8% (95% CI [84.8%, 93.6%]), respectively. Conclusion: This study demonstrates satisfactory measurement capabilities of the Q1.6 Inguinal Hernia application for identifying postoperative complications following inguinal hernia repair. However, certain aspects require further improvement, such as addressing error-prone questions, enhancing long-term compliance, and validating (pain) measurements through prospective control data. Trail registration number: NL7813 (Dutch Trial Registry), 19 May 2019. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to compare oral health‐related quality of life (OHRQoL) among adolescents granted (G) versus not granted (NG) publicly funded orthodontic treatment. Materials and Methods: Adolescents aged 15–20 years who were granted versus not granted publicly funded orthodontic treatment responded to a web‐based survey, assessing OHRQoL in relation to functional impact, psychological impact, and motivators for orthodontic treatment. Before the survey, pretesting of the questionnaire was conducted to ensure its reliability. Differences between the groups were tested using the chi‐squared and Mann–Whitney U‐tests. Reliability was assessed using Cohen's κ and Pearson's correlation coefficient during the pretest phase. Results: One hundred and forty patients, equally distributed between a G and an NG group, responded to the survey. Gender, age, and demographic distribution were comparable in both groups. All respondents expressed a high subjective treatment need and similar answers regarding functional aspects. Orthodontic treatment motivators (G: 86.2% and NG: 94.7%, p = 0.443) were primarily related to improved self‐esteem, overall well‐being, facial appearance, and being able to laugh without embarrassment. The NG group expressed a more negative OHRQoL impact due to the appearance of their teeth compared with the G group (p < 0.001) and a negative impact caused by the position of their teeth (p < 0.001). Conclusions: Orthodontic treatment need indices should aim to reinforce subjective measures as adolescents express similar motivators for orthodontic treatment, regardless of the clinician's objectively based decision about treatment need. [ABSTRACT FROM AUTHOR]

Background: Patient-reported outcome measures quantify outcomes from patients' perspective with validated instruments. QuickDASH (Quick Disability of Arm, Shoulder and Hand, an upper extremity PROM) scores improve after completing instrument tasks, suggesting patient-reported outcome results can be modified. We hypothesized that performing lower extremity tasks on the knee injury and osteoarthritis outcome score for joint reconstruction (KOOS-JR) and hip disability and osteoarthritis outcome score for joint reconstruction (HOOS-JR) instruments would similarly improve the scores. Methods: Forty seven hip and 62 knee osteoarthritis patients presenting to a suburban academic center outpatient osteoarthritis and joint replacement clinic were enrolled and randomized to an intervention or a control group. Inclusion criteria were age over 18 years and English competency. Patients completed a HOOS-JR or KOOS-JR instrument, completed tasks similar to those of the instrument (intervention) or the QuickDASH (control), and then repeated instruments again. Paired and unpaired t-tests were used to compare the intervention and control group scores before and after tasks. Results: There was no significant difference in total or individual scores after task completion compared to baseline in either the HOOS-JR or the KOOS-JR groups. There was no significant difference in the scores between the intervention or control groups. Conclusions: Disability may be less modifiable in the lower extremity than in the upper extremity, perhaps because upper extremity activities are more easily compensated by the contralateral limb, or because lower extremity activities are more frequent. Thorough evaluation of factors influencing patient-reported outcome measures is necessary before their extensive application to quality control and reimbursement models. [ABSTRACT FROM AUTHOR]

Background/Aim: Preterm pre-labour rupture of the membranes could be caused by the change in local cytokines concentration due to inflammatory or infectious conditions. Cytokines, such as chemokine generated by immune cells that have been activated are the most extensive category of biochemical factors implicated in the development of preterm pre-labour rupture of the membranes (PPROM). Among this chemokine, eotaxin serves as a specific protein that attracts eosinophils. Aim of this study was to assess the diagnostic accuracy of eotaxin-2 as a marker for the diagnosis of PPROM. Methods: A case-control study was conducted in the Department of Obstetrics and Gynaecology at Bagdad Teaching Hospital, Iraq during a period of 10 months. The study sample included 90 pregnant women and was divided into three groups, the first group: 30 women with PPROM, the second group: 30 women with preterm labour and intact foetal membranes and the third group: 30 women at term pregnancy. For all women in the study blood samples were taken for measurement of eotaxin-2 at the same gestational age. Results: The eotaxin-2 level was found to be lower in cases of PPROM than in preterm labour and term cases. The sensitivity of eotaxin-2 was 83.3 %, specificity 70 % and negative predictive value 89.4 %. Conclusion: Eotaxin-2 might be considered as a marker for diagnosis of PPROM. [ABSTRACT FROM AUTHOR]

The Chalder Fatigue Scale, also known as the Chalder Fatigue Questionnaire (CFQ) is a Patient Reported Outcome Measure (PROM) comprising 11 items designed to measure physical and cognitive fatigue. It is widely used with people with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). There is no published evaluation of the content validity of the CFQ. To elicit information regarding the cognitive processes undertaken by people living with ME/CFS, when completing the CFQ to allow examination of the CFQ's content validity. A qualitative study utilising semi-structured cognitive interviewing. All data were collated according to the CFQ item but some general criticisms of the content validity of the CFQ were also identified. The CFQ currently consists of one item clearly related to physical symptoms (1.6), four items clearly related to cognitive function (1.8, 1.9, 1.10, 1.11) and one item relating to fatigue (1.5) which could be interpreted as cognitive and/or physical fatigue. The other five items have been identified by participants as lacking clarity (1.1, 1.7), relating to behaviour not symptoms (1.2, 1.4), or relating to sleepiness not fatigue (1.3). Participants provided a wealth of insight into the challenges related to relevance, comprehensiveness, and comprehensibility of the CFQ, indicating that revision is required. This strengthens the case for participation of people with lived experience at all stages of PROM development. There is a need for an assessment tool/PROM for clinical and research use ME/CFS which has undergone content validation involving people living with ME/CFS. [ABSTRACT FROM AUTHOR]

• PFMT-P is a valid and reliable measurement tool suitable for Turkish culture that consists of knowledge, knowledge source and implementation variables. • The PFMT-P is a short, comprehensive and useful tool that can be used in both reproductive and menopausal women. Although there are several patient reported outcome measures (PROM) regarding knowledge, source of knowledge and practice about pelvic floor muscle training (PFMT), there is a lack of a valid and reliable PROM that includes the practice component of PFMT along with knowledge and source of knowledge. There is no valid and reliable measurement tool in Turkish used for this purpose. In this context, the aim of our study is to evaluate the psychometric properties of Pelvic Floor Muscle Training Patient Reported Outcome Measures (PROM) (PFMT-P) and to test whether it is a valid and reliable measurement tool for Turkish women. This study has been carried out psychometric testing (validity and reliability) of a new assessment tool concerning PFMT-P. A total of 170 female healthcare professionals (midwives, nurses, doctors, physiotherapists) who were between the ages of 23 and 49 and who volunteered to participate were included in the study. SPSS 25.0 and LİSREL 8.80 statistical programs were used for the analysis of data. Descriptive statistics were evaluated with numbers, percentages and means. Content validity index and confirmatory factor analysis were used for validity. Cronbach Alpha value and test–retest were used for reliability. Level of significance was p < 0.05. Content validity index (CVI) was found to be 0.96 for the overall scale. Model fit indices were found as perfect and good matched. Cronbach's alpha coefficient was found as 0.813 for the overall scale. Test-retest correlation was found as 0.658, it was 0.998 for practice component and 0.997 for source of knowledge component and a positive, significant and high correlation was found. It has been determined that PFMT-P is a valid and reliable measurement tool suitable for Turkish culture. With this, it is a short, comprehensive and useful tool that can be used in both pregnancy and the postpartum period for women of reproductive age or menopause. [ABSTRACT FROM AUTHOR]

Background: No widely accepted, validated instrument currently exists to measure clinical outcomes in patients who undergo dacryocystorhinostomy (DCR) for treatment of epiphora. Objective: To develop a patient-reported outcome measure applicable to this population. Methods: Psychometric evaluations, consultation with experts, and review of the literature informed item generation of a 12-question questionnaire to incorporate the most relevant symptoms experienced by patients with nasolacrimal duct obstruction. This questionnaire, known as the Tearing Assessment and Rating Scale-12 (TEARS-12), was administered to 32 patients before and after intervention, in the form of endoscopic DCR. Statistical analysis was performed to measure internal consistency, responsiveness, and test-retest reliability. Results: Pre-operative and post-operative TEARS-12 scores (28.2 [standard error (SE) 3.19] vs 11.8 [SE 3.25], respectively, P = 0.001) demonstrated improved patient outcome within 6 weeks following endoscopic DCR. Cronbach's alpha for the questionnaire was 0.90, indicating high overall reliability. Additionally, each question demonstrated internal reliability, with a corrected item-total correlation greater than 0.30. The intraclass correlation between the two pre-operative scores was 0.858 (P < 0.001), indicating high test-retest reliability. Conclusion: TEARS-12 is a statistically valid, easy-to-administer instrument to measure clinical outcomes in patients who undergo endoscopic DCR. [ABSTRACT FROM AUTHOR]

Background: Hand burns are involved in 80–90% of severe burn injuries. Even though hands correspond to a small total burn surface area (TBSA) of less than 5%, the loss of their functionality has a significant impact on the patient's life. Studies that provide long-term results regarding hand functionality after hand burns are scarce. Therefore, this study aimed to investigate functional long-term results in a patient-centric approach regarding burn depth, unilateral and bilateral hand involvement, and (non-)isolated hand burns as potential influencing factors in patients with hand burns. Methods: We conducted a controlled cohort study of patients with burned hands treated at our department between 2005 and 2022. Healthy age-, sex-, and handedness-matched participants were used as controls. Data on the demographics, burn-related injuries, and treatments were collected. For a patient-centric approach, we used the Disabilities of the Arm, Shoulder, and Hand Questionnaire (Quick-DASH) and the Michigan Hand Questionnaire (MHQ) as patient-reported outcome measures for functional long-term evaluation, and the Patient and Observer Scar Assessment Scale (patient scale) for assessing long-term scar quality. Results: We enrolled 61 patients with 88 affected hands and 63 matched control participants. Up to 77.1% of the participants were male, with a mean age of 50.7 (±15.5) years and a follow-up of 8.1 (±4.7) years. The mean TBSA was 13.9% (±15.8), with 72.4% of the hands presenting with deep partial-thickness and full-thickness burns and most of the patients had only one hand affected (55.7%). The hand burn patients perceived significantly worse long-term functional scores in every domain of the MHQ as well as in the "overall function" and "work" of the Quick-DASH. Superficial hand burns negatively affected the two-handed activities of daily living (p = 0.013) and aesthetic appearance (p = 0.005) when both hands were involved. Isolated hand burns were associated with more difficulties in work performance (p = 0.03), whereas patients with bilateral hand involvement perceived more pain (p = 0.025). Conclusions: The patients with hand burns can achieve satisfactory long-term functional outcomes over time, but they do not reach the same long-term hand functionality as the healthy matched control group. Our study revealed that factors such as burn depth, unilateral or bilateral hand involvement, and (non-)isolated hand burns indeed have an impact on certain aspects of perceived long-term hand functionality. [ABSTRACT FROM AUTHOR]

To translate ABILHAND-NMD and ACTIVLIM into Norwegian and assess their psychometric properties in adults with Myotonic Dystrophy type 1(DM1). ABILHAND-NMD and ACTIVLIM were translated into Norwegian through a standardized translation process. Psychometric properties of the translated questionnaires were tested. Intraclass correlation coefficient (ICC3.1) was used to assess test-retest reliability and Cronbach's α for internal consistency. The validity of the questionnaires was also assessed. A total of 39 adults with DM1 were included. We found excellent test-retest reliability on ABILHAND-NMD (ICC 0.91) and ACTIVLIM (ICC 0.93). We found a good internal consistency of ABILHAND-NMD with Cronbach's α (95%CI) of 0.80 (0.69–0.88) and ACTIVLIM with Cronbach's α (95%CI) of 0.88 (0.82–0.93) An expert group of healthcare professionals and a pilot group reported good face and content validity. We found a high correlation between ABILHAND-NMD and ACTIVLIM (r = 0.75), p < 0.001 implying good convergent validity. ABILHAND-NMD and ACTIVLIM showed no floor effect, but a potential for ceiling effect. The Norwegian versions of ABILHAND-NMD and ACTIVLIM are reliable and valid patient reported outcome measures for Myotonic Dystrophy type 1. The questionnaires are easy to administer as they take a short time to answer, and the participants reported no problems understanding the questions. Myotonic Dystrophy type 1 cause myopathy and altered muscle function. Impaired arm- and hand function increases patients' need for assistance and reduces independence. The use of patient reported outcome measures (PROMs) to uncover impairments and activity limitations is important in clinical practice and research. The Norwegian versions of ABILHAND-NMD and ACTIVLIM are reliable and valid measures of manual ability and activity limitations for adults with Myotonic Dystrophy type 1. [ABSTRACT FROM AUTHOR]

Introduction: Distal radius fracture (DRF) is one of the three most common fractures of the human body with increasing incidences in all groups of age. Known causes of increasing incidence, such as ageing of the population or increased obesity, have been described and discussed. So far, literature reports ambivalent effects of body mass index (BMI) on bone physiology. It is worthwhile to examine the influence of BMI on the outcome of fractures more detailed. This study aims to investigate the influence of an abnormal BMI on fracture severity and treatment, as well as clinical, radiological, and functional outcome to improve clinical decision making. Materials and methods: A retrospective observational study was conducted on data obtained from patients, who underwent open reduction and internal fixation (ORIF) of a DRF at a local Level 1 Trauma Center between May 2018 and October 2021. Follow-up examinations were performed approximately 1 year after surgical fracture treatment, during which various questionnaires and functional measurements (CMS, DASH, NRS, ROM) were applied. In addition, postoperative complications were recorded and radiological examinations of the affected hand were performed. After excluding incomplete data sets and applying set exclusion criteria, the complete data of 105 patients were analyzed. Results: 74 patients were female and 31 male with significant difference in mean BMI [p = 0.002; female: 23.8 (SD ± 3.3), men: 26.2 (SD ± 3.9)]. Patients with higher BMI had significantly more severe fractures (p = 0.042). However, there was no significant difference in surgery time for fracture management. At follow-up, patients with lower BMI showed a smaller difference in hand strength between the fractured and the other hand (p = 0.017). The BMI had no significant effect on the clinical and radiological outcome. Conclusion: Despite the ambivalent effects of BMI on the skeletal system, our findings indicate that a higher BMI is associated with more severe DRF. Thereby BMI does not correlate with surgery time for fracture treatment. Furthermore, no evidence of an influence on the clinical and radiological outcome could be detected. [ABSTRACT FROM AUTHOR]

Purpose: Patient-reported outcome measures (PROMs) are used to collect data on disease symptoms in support of clinical trial endpoints. Clinical studies can last a year or more, and the patients' adherence and response time to daily at-home questionnaires may vary significantly over time. The aim of this study was to understand patterns and changes in patients' completion of daily PROMs during longitudinal clinical studies. Methods: Data were collected from 1342 patients randomized into three respiratory clinical trials (NCT03401229, NCT03347279, and NCT03406078). PROMs were completed by patients using electronic handheld devices that collected the starting and completion times. A Bayesian generalized linear mixed-effects model was used to identify unbiased coefficients associated with PROM adherence and response time using patient, site, and calendar features as covariates. Results: Adherence decreased over time after randomization, and the rate of decrease was higher in younger patients. The 14-day pre-randomization adherence was correlated with adherence throughout the study. Patients were also more adherent during working days compared to non-working days. Oldest patients took twice as long to complete PROMs throughout the study; however, the response time for all patients decreased during the first month of the study regardless of age. Response time increased 7 days before and after the date of a scheduled clinic visit and when a patient-reported higher symptom burden. Conclusion: Detailed analyses of adherence and response time for daily PROMs in clinical trials can provide significant insights about trends of patient behavior in longitudinal clinical studies with high baseline adherence. [ABSTRACT FROM AUTHOR]

Background: It is difficult to recognize vitamin B12 deficiency and to evaluate the effect of B12 treatment due to a broad range of variable clinical symptoms overlapping with other diseases and diagnostic biomarkers that quickly normalize during treatment. This poses a risk of delay in diagnosis and a challenge to uniformly monitor the effect of B12 treatment. There is a need for a new clinical outcome measure suitable for clinical practice and clinical evaluation studies. Objective: To develop a Patient-Reported Outcome Measure (PROM) which measures the severity of vitamin B12 deficiency symptoms. Methods: The B12 PROM was developed by (1) gathering input from experts and literature review to define a construct and develop a conceptual model, (2) processing input from health care providers, scientists, and patients to develop items and response options, and (3) improving items based on the feedback from laypersons, test interviews, semi-structured cognitive interviews with patients, and forward and backward translation (ENG-NL). Results: The B12 PROM includes 62 items grouped into 8 categories of symptoms related to vitamin B12 deficiency (General, Senses, Thinking, In limbs and/or face, Movement, Emotions, Mouth & Abdomen, Urinary tract & Reproductive organs). Cognitive interviews demonstrated good comprehensibility and comprehensiveness. Conclusions: This study is the first step in the development of a disease-specific PROM for vitamin B12 deficiency to measure the burden of symptoms. Further validation and reliability testing are necessary before the PROM can be applied in clinical practice and research. Plain language title: Development of a Vitamin B12 Deficiency Questionnaire for Clinical Practice and Research Plain language summary: This study is the first step in the development of a questionnaire for vitamin B12 deficiency to measure the severity of vitamin B12 deficiency symptoms. The questionnaire includes 62 items grouped into 8 categories of symptoms related to vitamin B12 deficiency (General, Senses, Thinking, In limbs and/or face, Movement, Emotions, Mouth & Abdomen, Urinary tract & Reproductive organs). Interviews with patients demonstrated good comprehensibility and comprehensiveness of the questionnaire. Further testing is necessary before the questionnaire can be applied in clinical practice and research. [ABSTRACT FROM AUTHOR]

Background: Revision total hip arthroplasties (RTHA) are associated with a higher complication rate than primary total hip arthroplasties (THA), and therefore it is important for patients to have realistic expectations regarding outcomes. The aim of this literature review was to gather and summarize the available evidence on patients' expectations following RTHA. Methods: A literature search was conducted in PubMed, PsycINFO, Cochrane, Google Scholar, Web of Science and Embase from inception to November 2023. Articles assessing patient expectations for RTHA were included. Methodological quality was assessed by two independent reviewers using the National Heart, Lung and Blood Institute (NIH) study quality assessment tool for observational cohort and cross-sectional studies. A qualitative analysis was performed involving the summarization of study characteristics and outcomes. Results: The search strategy generated 7,450 references, of which 5 articles met the inclusion criteria. Methodological quality scores ranged from 7–10. Patients had high expectations concerning future walking ability, pain and implant longevity relative to actual postoperative outcomes. A significant positive correlation was found between fulfilled expectations of pain and walking ability and patient satisfaction (r = 0.46–0.47). Only two studies assessed the fulfillment of patient expectations. Great variability was seen in the measurement of expectations. Conclusion: Patients undergoing RTHA appeared to have high expectations for pain and functionality compared to postoperative outcomes. However, there was a paucity of high-quality data in this area, limiting the accuracy of the conclusion. Further research is needed, that emphasizes developing a sound theoretical framework for expectations, allowing for the consistent implementation of valid measurement tools for patient expectations. [ABSTRACT FROM AUTHOR]

Background: A congenital disease is for life. Posterior hypospadias, the severe form of hypospadias with a penoscrotal, scrotal, or perineal meatus, is a challenging condition with a major impact on lifelong quality of life. Aim: Our network meeting is aimed to identify what is currently missing in the lifelong treatment of posterior hypospadias, to improve care, quality of life, and awareness for these patients. Methods: The network meeting "Lifelong Posterior Hypospadias" in Utrecht, The Netherlands was granted by the European Joint Programme on Rare Diseases–Networking Support Scheme. There was a combination of interactive sessions (hackathons) and lectures. This paper can be regarded as the last phase of the hackathon. Results: Surgery for hypospadias remains challenging and complications may occur until adulthood. Posterior hypospadias affects sexual function, fertility, and hormonal status. Transitional care from childhood into adulthood is currently insufficiently established. Patients should be more involved in defining desired treatment approach and outcome measures. For optimal outcome evaluation standardization of data collection and registration at European level is necessary. Tissue engineering may provide a solution to the shortage of healthy tissue in posterior hypospadias. For optimal results, cooperation between basic researchers from different centers, as well as involving clinicians and patients is necessary. Conclusions: To improve outcomes for patients with posterior hypospadias, patient voices should be included and lifelong care by dedicated healthcare professionals guaranteed. Other requirements are joining forces at European level in uniform registration of outcome data and cooperation in basic research. [ABSTRACT FROM AUTHOR]

Background: Patient-reported outcome measures (PROMs) correlate with heart failure (HF) severity among adults and are adjunct tools in clinical care. Limited data exist regarding the validity of PROMs in pediatric HF. Hypothesis: Patient-Reported Outcome Measurement Information System (PROMIS) Pediatric Fatigue correlates with HF severity, measured by the New York University Pediatric Heart Failure Index (NYU PHFI). Methods: Children ≥8 and

Abstract Introduction Previable premature rupture of membrane (PV‐PROM) is a complex clinical situation posing considerable risks to the foetus. There is an extreme paucity of management options and clear guidelines in the literature for this dismal situation. This is the first report on usage of a novel combination of cellular therapeutic agents in a case of PROM. This study reports the earliest gestational age at which a case of spontaneous PV‐PROM (sPV‐PROM) has been successfully dealt by active management and, the longest period of continuation of pregnancy in a singleton sPV‐PROM for a total of 149 days. Objective To study the benefit of Intraamniotic Injection of PRF and PRP (IFPRP) in an index case of PV‐PROM. Design This is a case report of a 26‐year‐old woman with a recurrent, sPV‐PROM at 14 weeks 2 days with a previous pregnancy loss due to PV‐PROM at 18 weeks managed in a private reproductive health hospital in Mysore, India. Methods Our subject underwent an elective cervical stitch at 14 weeks. She had confirmed, repeated episodes of leak after 30 h of the procedure. Apart from aggressive management to control infection with vaginal asepsis, an Intraamniotic injection of 9 mL of autologous PRF and 4.5 mL of PRP was done under ultrasound guidance. The pregnancy was monitored closely for signs of infection and foetal wellbeing. Results The amniotic fluid leak stopped immediately after IFPRP for 36 h. After two more bouts of small leak, it stopped completely. She delivered a healthy baby of 3.4 kg at 35 weeks 4 days. The mother and baby did well postnatally. Conclusion Our protocol for fixing the leak is simple, easy to use, and can be done in resource‐poor settings which we consider is a big advantage. Further studies are needed to explore its potential in treating PROM.