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

BACKGROUND: Mucositis is a common and highly impactful side effect of conventional and emerging cancer therapy and thus the subject of intense investigation. Although common practice, mucositis assessment is heterogeneously adopted and poorly guided, impacting evidence synthesis and translation. The Multinational Association of Supportive Care in Cancer (MASCC) Mucositis Study Group (MSG) therefore aimed to establish expert recommendations for how existing mucositis assessment tools should be used, in clinical care and trials contexts, to improve the consistency of mucositis assessment. METHODS: This study was conducted over two stages (January 2022-July 2023). The first phase involved a survey to MASCC-MSG members (January 2022-May 2022), capturing current practices, challenges and preferences. These then informed the second phase, in which a set of initial recommendations were prepared and refined using the Delphi method (February 2023-May 2023). Consensus was defined as agreement on a parameter by >80% of respondents. FINDINGS: Seventy-two MASCC-MSG members completed the first phase of the study (37 females, 34 males, mainly oral care specialists). High variability was noted in the use of mucositis assessment tools, with a high reliance on clinician assessment compared to patient reported outcome measures (PROMs, 47% vs 3%, 37% used a combination). The World Health Organization (WHO) and Common Terminology Criteria for Adverse Events (CTCAE) scales were most commonly used to assess mucositis across multiple settings. Initial recommendations were reviewed by experienced MSG members and following two rounds of Delphi survey consensus was achieved in 91 of 100 recommendations. For example, in patients receiving chemotherapy, the recommended tool for clinician assessment in clinical practice is WHO for oral mucositis (89.5% consensus), and WHO or CTCAE for gastrointestinal mucositis (85.7% consensus). The recommended PROM in clinical trials is OMD/WQ for oral mucositis (93.3% consensus), and PRO-CTCAE for gastrointestinal mucositis (83.3% consensus). INTERPRETATION: These new recommendations provide much needed guidance on mucositis assessment and may be applied in both clinical practice and research to streamline comparison and synthesis of global data sets, thus accelerating translation of new knowledge into clinical practice. FUNDING: No funding was received.

PURPOSE: The Quality of Recovery-15 (QoR-15) tool, validated for measuring postoperative recovery following scheduled surgeries, has not been psychometrically assessed in emergency contexts. Moreover, the QoR-15s associations with long-term outcomes remain underexplored. This study aimed to confirm the validity and reliability of the QoR-15 following emergency surgery and assess its association with three-month postoperative quality of life. METHODS: We conducted a prospective cohort study (August 2021-April 2022) on adult patients who underwent emergency surgery. The QoR-15 questionnaire was administered before surgery (H0) and at 24 hr (H24) and 48 hr (H48) after surgery. We examined the H24 scores associations with both the three-month quality of life, as assessed by the EQ-5D scale, and the number of days spent at home at 30 (DAH30) and 90 (DAH90) days. RESULTS: Of the 375 included patients, 352 (94%) completed the QoR-15 at H24 and 338 (90%) were followed up at three months. The population represented the following diverse surgical specialties: orthopedic (51%), gastrointestinal (27%), urologic (13%), and others (9%). The QoR-15 questionnaire confirmed all psychometric qualities (internal consistency, reproducibility, responsiveness, acceptability, construct, and convergent validities) in the emergency context. The average minimum clinical difference was 8.0 at H24. There was an association between QoR-15 at H24 and the three-month quality of life (r = 0.24; 95% confidence interval [CI], 0.14 to 0.34; P

Abstract: Background: Fatigue and neurocognitive impairment are highly prevalent in patients with glioma, significantly impacting health-related quality of life. Despite the presumed association between these two factors, evidence remains sparse. Therefore, we aimed to investigate this relationship using multinational data. Methods: We analyzed data on self-reported fatigue and neurocognitive outcomes from postoperative patients with glioma from the University of California San Francisco (n = 100, UCSF) and Amsterdam University Medical Center (n = 127, Amsterdam UMC). We used multiple linear regression models to assess associations between fatigue and seven (sub)domains of neurocognitive functioning and latent profile analysis to identify distinct patterns of fatigue and neurocognitive functioning. Results: UCSF patients were older (median age 49 vs. 43 years, P = .002), had a higher proportion of grade 4 tumors (32% vs. 18%, P = .03), and had more neurocognitive deficits (P = .01). While the number of clinically fatigued patients was similar between sites (64% vs. 58%, P = .12), fatigue and the number of impaired neurocognitive domains were not correlated (P = .16–.72). At UCSF, neurocognitive domains were not related to fatigue, and at Amsterdam UMC attention and semantic fluency explained only 4–7% of variance in fatigue. Across institutions, we identified four distinct patterns of neurocognitive functioning, which were not consistently associated with fatigue. Conclusions: Although individual patients might experience both fatigue and neurocognitive impairment, the relationship between the two is weak. Consequently, both fatigue and neurocognitive functioning should be independently assessed and treated with targeted therapies.

Purpose: Implant-based breast reconstruction (IBR) is being increasingly performed with implant placed above the pectoral muscle (pre-pectoral), instead of below the pectoral muscle (sub-pectoral). Currently, there is a lack of comparative data on clinical and patient-perceived outcomes between pre- vs. sub-pectoral IBR. We investigated whether this difference in surgical approach influenced clinical or patient-perceived outcomes. Methods: This prospective non-randomised longitudinal cohort study (ClinicalTrials.gov identifier: NCT04842240) recruited patients undergoing immediate IBR at the Leeds Breast Unit (Sep 2019–Sep 2021). Data collection included patient characteristics and post-operative complications. Patient-Reported Outcome Measures were collected using the BREAST-Q questionnaire at baseline, 2 weeks, 3- and 12-months post-surgery. Results: Seventy-eight patients underwent IBR (46 patients pre-pectoral; 59% vs. 32 patients sub-pectoral; 41%). Similar complication rates were observed (15.2% pre-pectoral vs. 9.4% sub-pectoral; p = 0.44). Overall implant loss rate was 3.8% (6.5% pre-pectoral vs. 0% sub-pectoral; p = 0.13). Respective median Breast-Q scores for pre- and sub-pectoral IBR at 3 months were: breast satisfaction (58 vs. 48; p = 0.01), psychosocial well-being (60 vs. 57; p = 0.9), physical well-being (68 vs. 76; p = 0.53), and Animation Q scores (73 vs. 76; p = 0.45). Respective Breast-Q scores at 12 months were: breast satisfaction (58 vs. 53; p = 0.3), psychosocial well-being (59 vs. 60; p = 0.9), physical well-being (68 vs. 78; p = 0.18), and Animation Q scores (69 vs. 73; p = 0.4). Conclusions: This study demonstrates equivalent clinical and patient-perceived outcomes between pre- and sub-pectoral IBR. The study findings can be utilised to aid informed decision making regarding either surgical option. [ABSTRACT FROM AUTHOR]

Purpose: We aimed to establish patient‐reported outcome measure (PROM) reference data for a cohort of patients with prior patellar dislocation without previous knee surgery. Methods: All inhabitants of the Faroe Islands aged 15–19 years were sent an online survey via secure email to establish a national cohort. They were asked to answer questions regarding demographics, whether they had prior patellar dislocation and to complete the PROMs: the Banff Patella Instability Instrument (BPII), Kujala, Marx activity and EQ‐5D‐5L questionnaires. Participants who had undergone knee surgery were excluded. Participants who had prior patellar dislocation underwent radiographic examinations to diagnose trochlear dysplasia. The study included three cohorts: the general population, prior patellar dislocation and prior patellar dislocation and trochlear dysplasia cohorts. Results: Of the 3749 individuals contacted, 1119 completed the survey and responded to at least one PROM. Of these, 102 reported a history of patellar dislocation and 57 of them had trochlear dysplasia. All PROMs, except the Marx score, reflected a worse quality of life and function after patellar dislocation than in the general population cohort; this was most pronounced in the BPII. The percentage of people experiencing problems in EQ‐5D‐5L dimensions was higher in the patellar dislocation and trochlear dysplasia cohorts than in the general population cohort in all EQ‐5D‐5L domains, except anxiety/depression. Conclusion: Adolescents who had patellar dislocation reported reduced quality of life and function according to the BPII, Kujala and EQ‐5D‐5L index values, as well as all EQ‐5D‐5L domains, except for anxiety/depression. However, their activity levels remained high. Level of Evidence: Level III. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the effect of baseline back pain severity on PROMIS mental health outcomes following minimally invasive lumbar decompression (LD). Methods: Patients undergoing elective, primary, single-level LD were retrospectively reviewed from a prospective single spine surgeon registry. Perioperative characteristics, demographics, and the following patient-reported outcomes (PROs) were extracted: Oswestry Disability Index (ODI)/Patient-Health Questionnaire-9 /PROMIS-Physical Function/Anxiety/Pain Interference/Sleep Disturbance (PROMIS-PF/A/PI/SD). Two cohorts were created: preoperative VAS-B < 7 and VAS-B ≥ 7. Change in PROs (ΔPROs) from baseline to six weeks/final follow-up were determined. Average patient follow-up was 13.4 ± 8.8 months. Minimal clinically important difference (MCID) achievement rates were calculated and compared through multivariable logistic regression. Postoperative scores and ΔPROs, were compared with multivariable linear regression while all other data was compared between groups with inferential statistics. Results: Altogether, 347 patients were included, with 190 in the VAS-B < 7 group. VAS-B ≥ 7 reported worse outcomes preoperatively (p ≤ 0.013, all). At six weeks, VAS-B ≥ 7 reported worse VAS-B (p = 0.017), with no other significant differences. At final follow-up, patients with worse VAS-B reported worse ODI (p = 0.040) and VAS-B while all other PROs were similar (p ≥ 0.078, all). VAS-B ≥ 7 experienced greater 6-week improvements in VAS-B/ODI/PROMIS-PI/PROMIS-SD (p ≤ 0.009, all), greater VAS-B/ODI/PROMIS-SD improvement by final follow-up (p ≤ 0.009, all) and greater MCID achievement in ODI/VAS-B (p ≤ 0.027). Conclusion: Patients with worse baseline back pain report inferior baseline scores that converge with those with milder preoperative back pain by 6 weeks after LD and reported greater 6-week improvements in disability, pain interference, and sleep disturbance by 6 weeks, and greater improvements in disability and sleep disturbance by final follow-up. [ABSTRACT FROM AUTHOR]

Background: The FACE‐Q Aesthetics is used extensively to measure patient reported outcomes for minimally invasive and surgical facial aesthetic treatments. We recently developed a new FACE‐Q scale to assess satisfaction with the appearance of the temples. Aim: The aim of this study was to field test the FACE‐Q Satisfaction with Temples scale to examine its psychometric properties. Methods: The FACE‐Q Satisfaction with Temples scale was administered to 171 adults (22 years or older) seeking minimally invasive treatment to improve temple hollowing as part of a clinical trial. The severity of temple hollowing was established through the clinician‐reported Allergan Temple Hollowing scale (clinician‐rated). The psychometric properties of the FACE‐Q Satisfaction with Temples scale were established by testing Rasch Measurement Theory (RMT) assumptions and model fit; unidimensionality by principal component analysis; and construct validity by hypothesis testing. Results: The study sample consisted of 171 adults (mean age 54.7 ± 9.9, range, 25–82 years). RMT analysis provided evidence for the scientific soundness of a 12‐item Satisfaction with Temples scale. The data fit the Rasch model (χ2 = 20.47, df = 24, p = 0.67), all items had ordered thresholds, and good item fit. Scale reliability was high, with Person Separation Index and Cronbach alpha values with and without extremes ≥0.93. Principal component analysis revealed a single component with high factor coefficients. Construct validity was established as scores for the Satisfaction with Temples and Face Overall scales were correlated (r = 0.623, p < 0.001). Conclusion: The FACE‐Q Satisfaction with Temples scale is a reliable and valid measure that can be used in clinical practice and research to measure outcomes following treatment for temple hollowing. [ABSTRACT FROM AUTHOR]

The Neck Disability Index (NDI), a common Patient-Reported Outcome Measure (PROM) for neck pain, lacks sufficient study on its psychometric properties in preoperative patients with cervical spondylotic myelopathy (CSM). This study aims to address these gaps by conducting an exploratory factor analysis of the Japanese NDI. The objectives are 2-fold: (1) to scrutinize the psychometric properties and internal consistency of the Japanese NDI, and (2) to explore the specific regions of pain and numbness influencing the NDI. A single-center observational study. A total of 100 preoperative patients with CSM. The NDI and Numerical Rating Scale (NRS) were employed to assess preoperative neck disability and pain and numbness in various body regions. Demographic and clinical characteristics were collected, encompassing age, sex, body mass index, American Society of Anesthesiologists classification, smoking status, comorbidities, pain and numbness at various sites using the NRS, and NDI. For evaluating the psychometric properties and internal consistency of the NDI, exploratory factor analysis (EFA) and Cronbach's α coefficient were utilized. Furthermore, the impact of pain and numbness on NDI factors was examined through multivariable regression analysis. EFA identified 2 factors—Physical and Mental—highlighting the dual nature of neck-related disability. Physical factors (std.β=0.724, p<.001) exerted a stronger impact on NDI scores compared to Mental factors (std.β=0.409, p<.001). Cronbach's α coefficient was 0.831 for physical factors and 0.723 for mental factors, indicating a high level of internal consistency. Numbness in the hand (std.β=0.338, p<.001) and pain in the neck (std.β=0.202, p=.035) were significant variables influencing Physical factor, while numbness in the hand (std.β=0.485, p<.001) and pain in the head (std.β=0.374, p<.001) impacted mental factor. This study contributes valuable insights into the psychometric properties of the NDI in preoperative patients with CSM. The identified factors emphasize the importance of addressing both physical and sensory symptoms in preoperative care. [ABSTRACT FROM AUTHOR]

Background: Patient-reported outcome measures (PROMs) can provide data on the barriers and facilitators of adherence to daily oral antiretroviral therapy (OART) regimens. We aimed to develop PROMs to understand the perspectives of people with HIV (PWH) on (1) facilitators/barriers to daily OART regimen adherence and (2) a hypothetical switch to a long-acting (LA)-OART regimen. Methods: Following the US food and drug administration patientreported outcome guidance, targeted literature reviews and concept elicitation interviews with clinicians (n = 7) and PWH (n = 28) were conducted to develop conceptual models (CMs) of facilitators/ barriers to OART regimen adherence. Three de novo PROMs were developed after an item-generation meeting. Three waves of cognitive debriefing interviews were conducted among PWH (n = 30) to demonstrate content validity and refine the PROMs. Results: The targeted literature review identified 25 facilitators/ barriers; an additional 16 facilitators/barriers were added by clinicians and PWH and represented in 2 CMs. During the itemgeneration meeting, the CMs were used to develop 3 de novo PROMs: (1) HIV Patient Perspective of Regimen, (2) HIV Patient Perspective of Regimen Change, and (3) HIV Drivers of Adherence Questionnaire. In the cognitive debriefing interviews, PWH corroborated the relevancy of items in the PROMs, and minor adjustments were made for clarity. Conclusion: Three content-valid PROMs were developed to understand the treatment experience of PWH taking daily OART and how that experience may be altered upon a switch to weekly LAOART. Data from future LA-OART clinical trials will help define a scoring guide and evaluate the structure and measurement properties of the PROMs. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the extent to which postoperative complications impact patient health-related quality of life (HRQoL) and survival after pancreatic surgery. Background: Pancreatectomy is frequently associated with severe postoperative morbidity, which can affect patient recovery. Few and conflicting data are available regarding the effect of post-pancreatectomy complications on patient-reported HRQoL. Methods: This is an observational cohort study including consecutive patients enrolled in a prospective clinical trial (NCT04431076) who underwent elective pancreatectomy (2020--2022). Before surgery and on postoperative days 15, 30, 90, and 180, patients completed the PROMIS-29 profile andDuke Activity Status Index questionnaires to assess their HRQoL and functional capacity. Mean differences in HRQoL scores were obtained using multivariable linear regression adjusting for preoperative scores and confounders. Results: Of 528 patients, 370 (70%) experienced morbidity within 90 days, and 154 (29%) had severe complications (Clavien-Dindo grade >2). Delayed gastric emptying had the greatest impact on HRQoL, showing decreased mental health up to POD90 and physical health up to POD180 compared with uncomplicated patients. An inverse relationship between complication severity grade and HRQoL was evident for most domains, with Clavien- Dindo grade 3b to 4 patients showing worse HRQoL and functional capacity scores up to 6 months after surgery. In 235 pancreatic cancer patients, grade 3b and 4 complications were associated with reduced disease-specific survival (median 25 vs 41 mo, P<0.001). Conclusions: In patients undergoing pancreatic resection, postoperative complications significantly impact all domains of patient quality of life with a dose--effect relationship between complication severity and impairment of HRQoL and functional capacity. [ABSTRACT FROM AUTHOR]

Remaining pain and functional limitations may cause dissatisfaction in patients after total knee arthroplasty (TKA). Furthermore, anxiety and depression are associated with remaining postoperative symptoms and dissatisfaction. We investigated if patient-reported anxiety or depression increased the risk of dissatisfaction 1 year after TKA in patients who improved in pain or function. Data on primary TKAs due to osteoarthritis between 2017 and 2019 were obtained from the Swedish Knee Arthroplasty Register. Out of 14,120 patients, 9,911 completed the Knee injury and Osteoarthritis Outcome Score and satisfaction rate with the result of the surgery. According to the Outcome Measures in Rheumatology—Osteoarthritis Research Society International criteria patients were classified as responders (improved in pain or function) or nonresponders. Anxiety and depression were assessed through EuroQol-5 Dimension 3 levels. Log-linear regression models estimated the risk ratios (RRs) for dissatisfaction in all patients and stratified by age groups (< 65, 65 to 74, and > 74 years). There were 8,745 patients who were classified as responders whereas 11% were defined as dissatisfied. The proportion of patients who reported anxiety or depression was 35% preoperatively and 17% postoperatively. Anxiety or depression increased the risk of dissatisfaction preoperatively (RR 1.23, 95% confidence interval = 1.09 to 1.40) and postoperatively (RR 2.65, confidence interval 2.33 to 3.00). Patients younger than 65 years reported preoperative anxiety or depression to a greater extent but did not have an increased risk of dissatisfaction. Patient-reported anxiety or depression preoperatively and postoperatively are important and potentially treatable factors to consider, as they were found to increase the risk of dissatisfaction after TKA despite improvements in pain or function. [ABSTRACT FROM AUTHOR]

Background: Post‐treatment surveillance recommendations for oropharyngeal cancer do not vary with p16 status despite the differences in outcomes. The optimal algorithm personalizing follow‐up for these patients remains undefined. Here, we evaluate the feasibility and utility of incorporating electronic patient‐reported outcomes (ePROs) and circulating tumor DNA (ctDNA) into routine surveillance for patients treated for p16+ oropharynx cancer. Methods: A prospective registry was developed in which ePROs and ctDNA were incorporated into routine surveillance among patients with oropharynx cancer. ePROs were emailed monthly for 1 year and blood HPV ctDNA testing was performed every 3–6 months. The primary objective was to assess patient compliance with ePRO‐based surveillance with adequate compliance defined as ≥85% of patients completing monthly ePROs. Sensitivity, specificity, and positive/negative predictive values to detect recurrence were calculated for ePROs, HPV ctDNA, or the combination. Results: Of 122 patients who initially expressed interest, 76 completed the electronic consent process and 44/76 (58%) were compliant with monthly surveys over 1 year; thus adequate compliance was not achieved. Technical difficulties associated with ePRO receipt through email largely limited participation. Provider feedback was significantly associated with heightened ePRO compliance. One hundred and six patients had ctDNA testing with a mean number of three tests per patient. Sensitivity to detect recurrence was 75% for the combination of ePROs and ctDNA. Conclusion: Despite lower than anticipated compliance with ePROs, our findings show promise for incorporation of HPV ctDNA into surveillance paradigms for HPV‐related oropharynx cancer with suggestions of methods to optimize ePRO formats for personalized surveillance. [ABSTRACT FROM AUTHOR]

Background : While frailty is a well-established predictor of overall mortality among patients with metastatic non-small cell lung cancer (mNSCLC), its association with patient-reported outcomes is not well-characterized. The goal of this study was to examine the association between an electronic frailty index (eFI) score and patient-reported outcome measures along with prognostic awareness among patients with mNSCLC receiving immunotherapy. Methods : In a cross-sectional study, patients with mNSCLC who were on immunotherapy completed the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) and the National Cancer Institute Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). We utilized bivariate analyses to compare quality of life, symptoms, supportive services, and prognostic awareness among 3 groups defined by e-frailty status. Results : Sixty patients (mean age 62.5 years, 75% Caucasian, 60% women) participated. Most patients were pre-frail (68%), with 13% being frail and 18% non-frail. Pre-frail and frail patients had significantly lower physical function scores (mean 83.9 fit vs 74.8 pre-frail vs 60.0 frail, P =.04) and higher rates of self-reported pain (75% frail vs 41.5% pre-frail vs 18.2% fit; P =.04) compared to non-frail patients. We found no differences in palliative referral rates. Conclusion : Pre-frail and frail mNSCLC patients identified by the eFI have higher rates of pain and physical functional impairments than non-frail patients. These findings highlight the importance of emphasizing preventive interventions targeting social needs, functional limitations, and pain management, especially among pre-frail patients to reduce further decline. [ABSTRACT FROM AUTHOR]

Background: The Utrecht Symptom Diary—4 Dimensional (USD-4D), an adaptation of the Edmonton Symptom Assessment System, supports healthcare providers (HCPs) in identifying, monitoring, and exploring multidimensional symptoms and needs of patients in the palliative phase. For the USD-4D to be optimally implemented in clinical palliative care, it is essential to know and understand the needs of HCPs when using it. Objective: To identify and interpret the needs of HCPs when using the USD-4D in clinical palliative care, operationalized as perceived facilitators and barriers. Design: An explanatory mixed-methods study with a sequential design. Methods: Data were collected between October 2019 and September 2020. In phase I, quantitative data were collected through a survey targeting Dutch HCPs working in palliative care. Facilitators were identified as items answered positively by ⩾80% of participants, while barriers were identified as items answered negatively by ⩾20% of participants. In phase II, these identified facilitators and barriers were explored in depth through mixed composition focus groups. The Capability-Opportunity-Motivation-Behavior (COM-B) model was utilized to contextualize and interpret the perceived facilitators and barriers. Results: A total of 122 HCPs completed the survey, with 95% of the respondents being women with a mean age of 48 years and 72% being nurses. Additionally, 53% of the respondents had no prior experience with the USD-4D. In phase II, 21 HCPs participated in focus groups. 95% of the participants were women with a mean age of 49 years and 67% being nurses. HCPs pinpointed facilitators primarily related to the potential benefits of the USD-4D for daily patient care. Conversely, the identified barriers included issues related to HCPs' behavior, knowledge gaps, uncertainty regarding their abilities and attitudes toward the USD-4D, and technical obstacles. Conclusion: Facilitators and barriers across all facets of the COM-B model were recognized, with a notable emphasis on motivational barriers. It should be acknowledged that facilitators and barriers can evolve throughout the implementation process, underscoring the importance of viewing implementation and integration as fluid and continuous endeavors. Facilitators and barriers are closely linked to HCPs' reflective capacities, emphasizing the need for tailored intervention strategies that align with different stages of USD-4D implementation. [ABSTRACT FROM AUTHOR]

Summary Background Methods Results Conclusion In the UK, approximately 70% of surgical procedures are undertaken as day‐cases. Little information exists about recovery from day‐case surgery, yet international data highlights patients are at risk of developing significant longer‐term health problems including chronic post‐surgical pain and persistent postoperative opioid use. The Patient‐reported Outcomes, Postoperative Pain and pain relief after daY case surgery (POPPY) study was a national prospective multicentre observational study, measuring short‐ and longer‐term patient‐reported outcomes, postoperative pain and pain relief after day‐case surgery.This was a collaborative project led by resident anaesthetists under the Research and Audit Federation of Trainees umbrella. Adult day‐case surgical patients were recruited on the day of surgery. Baseline data including patient characteristics; procedure details; pre‐operative analgesic use; pre‐existing pain; and quality of life scores were recorded. Patients were followed up through automated short message service messages. Short‐term (postoperative days 1, 3 and 7) outcomes included: quality of recovery; pain severity; impact of pain on function; and analgesic use. Longer‐term outcomes (postoperative day 97) included: quality of life; analgesic use; incidence of chronic post‐surgical pain; and incidence persistent postoperative opioid use. Additional outcomes were completed by those patients with chronic post‐surgical pain and persistent postoperative opioid use, with 30 patients recruited to a qualitative semi‐structured interview study exploring postoperative expectations, recovery, postoperative pain and opioid use.An embedded pilot study at four sites recruited 129 patients. Responses to the automated short message service were gained from 129 patients (100%) at day 1; 116 (89.9%) at day 3; 108 (83.7%) at day 7; and 77 (59.7%) at day 97 postoperatively. The pilot enabled refinement of the methods and processes before the national roll out.This paper outlines the methods for the POPPY study, the largest UK multicentre prospective observational study considering short‐ and longer‐term outcomes following day‐case surgery. [ABSTRACT FROM AUTHOR]

Objectives Methods Results Conclusions We assessed the opinions of physicians caring for people with HIV (PWH) from the multicentre Spanish CoRIS cohort regarding the assessment of health‐related quality of life (HRQoL).We designed an online self‐administered questionnaire comprising 27 structured questions across four domains: (i) sociodemographic and clinical data; (ii) usefulness of measuring HRQoL; (iii) information, training and resource needed; and (iv) whether and how HRQoL should be measured. Physicians completed the questionnaire between April and June 2023.Of 131 physicians surveyed [53.8% men, median age 52 years (interquartile range: 42–60)], 90.9% and 88.6% agreed that measuring HRQoL is useful for both PWH and medical decision‐making, respectively. However, 67.2% needed training on what HRQoL is and how to measure it, 79.4% required information on validated tools, and 80.9% felt that clinical guidelines are needed. Overall, 90.1% of physicians agreed that HRQoL should be measured among PWH. Most physicians (82.8%) supported using specific scales for PWH, with 74.1% recommending annual measurement, 49.1% suggesting that nurses from HIV units conduct the assessments, and 43.1% favouring personal interviews during medical visits. At the time of the survey, 55.3% of physicians did not measure HRQoL in any patients due to time or resource constraints (75.8%).Despite the recognized importance of HRQoL measurement in PWH, Spanish physicians encounter barriers such as time constraints and limited resources. Developing clear guidelines, using tailored scales, and integrating digital tools along with multidisciplinary support could enhance routine HRQoL assessments and improve patient‐centred care. [ABSTRACT FROM AUTHOR]

Background Method Results Conclusion CRUSE® is an app that allows patients with chronic spontaneous urticaria (CSU) to monitor their daily disease activity through the use of visual analogue scales (VASs). We aimed to determine the concurrent validity, reliability, responsiveness and minimal important difference (MID) of CRUSE® VASs.We evaluated the properties of three daily VASs: VAS for how much patients were affected by their CSU (‘VAS urticaria’), VAS for the impact of urticaria on work/school productivity (‘VAS productivity’) and the VAS of EQ‐5D. Concurrent validity was assessed by measuring the association between each VAS and the Urticaria Activity Score (UAS). Intra‐rater reliability was determined based on the data of users providing multiple daily questionnaires within the same day. Test–retest reliability and responsiveness (ability to change), respectively, were tested in clinically stable and clinically unstable users. MIDs were determined using distribution‐based methods.We included 5938 patients (67,380 days). Concurrent validity was high, with VAS urticaria being more strongly associated with the UAS score than the remaining VASs. Intra‐rater reliability was also high, with intraclass correlation coefficients (ICC) being above 0.950 for all VASs. Moderate‐high test–retest reliability and responsiveness were observed, with reliability ICC being highest for VAS EQ‐5D and responsiveness being highest for VAS urticaria. The MID for VAS urticaria was 17 (out of 100) units, compared to 15 units for VAS productivity and 11 units for VAS EQ‐5D.Daily VASs for CSU available in the CRUSE® app display high concurrent validity and intra‐rater reliability and moderate‐high test–retest reliability and responsiveness. [ABSTRACT FROM AUTHOR]

Introduction Methods Results Conclusion Long‐acting injectable antipsychotics (LAIs) are not routinely offered to patients living with bipolar disorder type I (BP‐I), despite widespread evidence that supports their benefits over oral antipsychotics, particularly in early disease.A round‐table meeting of psychiatrists convened to discuss barriers and opportunities and provide consensus recommendations around the early use of LAIs for BP‐I.LAIs are rarely prescribed to treat BP‐I unless a patient has severe symptoms, sub‐optimal adherence to oral antipsychotics, or has experienced multiple relapses. Beyond country‐specific accessibility issues (e.g., healthcare infrastructure and availability/approval status), primary barriers to the effective use of LAIs were identified as attitudinal and knowledge/experience‐based. Direct discussions between healthcare providers and patients about treatment preferences may not occur due to a preconceived notion that patients prefer oral antipsychotics. Moreover, as LAIs have historically been limited to the treatment of schizophrenia and the most severe cases of BP‐I, healthcare providers might be unaware of the benefits LAIs provide in the overall management of BP‐I. Improved treatment adherence associated with LAIs compared to oral antipsychotics may support improved outcomes for patients (e.g., reduced relapse and hospitalization). Involvement of all stakeholders (healthcare providers, patients, and their supporters) participating in the patient journey is critical in early and shared decision‐making processes. Clinical and database studies could potentially bridge knowledge gaps to facilitate acceptance of LAIs.This review discusses the benefits of LAIs in the management of BP‐I and identifies barriers to use, while providing expert consensus recommendations for potential solutions to support informed treatment decision‐making. [ABSTRACT FROM AUTHOR]

Importance: Chronic rhinosinusitis (CRS) is a common inflammatory disease of the paranasal sinuses with significant quality of life impairments. There is a need to implement outcome-based metrics to evaluate the outcomes of CRS treatment with endoscopic sinus surgery or biologics. Objective: We aimed to understand Canadian otolaryngologists' opinions on patient-related outcome measures (PROM) for CRS and identify potential barriers to implementation. Design: Qualitative research. Setting and Participants: A cross-sectional survey was distributed via the Canadian Society of Otolaryngology-Head and Neck Surgery and direct emailing. Measures: Participants' demographics, practice information, and opinions on PROM were collected. Results: Of 346 (23%) Canadian otolaryngologists, 78 responded to the survey (26 rhinology fellowship–trained, 51 non-fellowship-trained, and 1 missing data). Thirty-eight responded that they collect PROM (69% with fellowship-trained, 39% non-fellowship-trained, P =.029). Regarding opinions on PROM, 74% of respondents agreed that it helps patients report their symptoms, 42% agreed that it improves the efficiency of the patient encounter, 54% agreed that it is easy for patients to understand, 62% agreed that it improves management and monitoring of clinical outcomes, and 71% disagreed that PROM is not helpful. Fellowship-trained otolaryngologists were 4 times more likely to agree that PROM improves management and monitoring of clinical outcomes (P =.014), and no other differences in opinions were significant. The most-frequently-identified barriers to PROM usage were lack of time for 67% of respondents, difficulty integrating into clinical workflow for 64%, and lack of integration into the electronic medical record for 47%. If these barriers were addressed, 86% of respondents said they would use PROM in their practice. Conclusions and Relevance: Despite the low uptake of PROM among otolaryngologists without rhinology fellowship, opinions were generally favorable. We identified barriers that, if addressed, may increase their use in clinical practice. As resource-limited therapies such as biologics become more prevalent in CRS management, PROM may find more applications in shared clinical decision making. [ABSTRACT FROM AUTHOR]

BackgroundObjectiveMethodResultsConclusionAssessing hand function is essential for many people with rheumatoid arthritis (RA). The Measure of Activity Performance of the Hand (MAP-Hand) allows a rapid evaluation of the hand.To translate the MAP-Hand into Turkish and investigate its psychometric properties.The MAP-Hand was translated into Turkish by using established translation guidelines. The questionnaire was pilot tested in 30 people with RA. Then, 185 adults with RA (150 women) participated in the study. Physical characteristics (age, sex, body mass index), socio-demographic information (education, employment, marital status), disease-related characteristics (RA medications, disease activity, duration of disease), hand strength (grip and pinch strengths), and patient reported outcome measures regarding pain, hand/upper extremity function, and general health status were collected. The Turkish MAP-Hand was re-administered to 109 participants in the following week.The Turkish MAP-Hand was acceptable and feasible to administer, and showed excellent internal consistency (Cronbach’s α = 0.952, confidence interval, CI = 0.942 to 0.962, p < .001). The unidimensionality of the Turkish MAP-Hand was confirmed by Rasch Analysis. Test–retest reliability was excellent (Intraclass Correlation Coefficient = 0.908, CI = 0.868 to 0.936, p < .001). The Turkish MAP-Hand showed moderate negative correlations with hand strength (Pearson’s r between −0.511 and −0.572, p < .05), and fair to excellent positive correlations with disease activity, pain, hand/upper extremity function, and general health status (Pearson’s r between 0.437 and 0.915, p < .05).The Turkish Map-Hand demonstrated adequate psychometric properties (internal consistency, structural validity, test–retest reliability, convergent validity) supporting the utility of its use for evaluating the activity performance of the hand in people with RA. [ABSTRACT FROM AUTHOR]

Background: Patient-reported outcome measures (PROMs) have gained increased importance in assessing outcomes after reconstructive surgery. This also applies to the reconstruction of vulvoperineal defects after resection of gynecological or colorectal cancers in women. The objective of this study is to analyze the current state of PROM tool use within this patient population. Methods: By systematic literature searches in Embase, Medline, and Web of Science, English-language studies published after 1980, including randomized controlled trials, cohort studies, and case series reporting on vulvoperineal defect reconstruction, which were included if they also analyzed quality of life (QoL) and/or PROMs. The PROM tools used by each study were extracted, analyzed, and compared. Results: The primary search yielded 2576 abstracts, of which 395 articles were retrieved in full text. Of these, 50 reported on vulvoperineal defect reconstruction, among which 27 studies analyzing QoL were found. Of those, 17 met the inclusion criteria for this systematic review. After full-text screening, 14 different PROM tools and 5 individual, non-standardized questionnaires were identified. Only 22% of studies used a validated PROM tool. Conclusion: Far too few studies currently use PROM tools to assess outcomes in oncological vulvoperineal defect reconstruction. Less than half of the used PROMs are validated. No PROM was designed to specifically measure QoL in this patient population. The standardized implementation of a validated PROM tool in the clinical treatment of this patient population is an essential step to improve outcomes, enable the comparison of research, and support evidence-based treatment approaches. [ABSTRACT FROM AUTHOR]

Background: Fatigue is a commonly reported clinical symptom, yet research on fatigue in children with severe asthma is missing. We aimed to explore the extent of fatigue in severe pediatric asthma and identify associated factors. Method: This study was conducted within the Pediatric Asthma Non‐Invasive Diagnostic Approaches (PANDA), an observational cohort of 6‐ to 17‐year‐old Dutch children with severe asthma. The Pediatric Quality of Life Inventory Multidimensional Fatigue Scale (PedsQL™‐MFS) was used to measure self‐reported fatigue. Fatigue levels were compared with a general pediatric Dutch population using linear regression, and quantifying the prevalence of "fatigued" (−2 < Standard deviations [SD] ≤ −1) and "severely fatigued" (SD ≤ −2) children. Secondly, we performed linear regression analyses to explore whether fatigue levels were independently associated with asthma attacks, comorbidities, medication, pulmonary function, symptom control, and asthma‐related quality of life (QoL). Results: Severe pediatric asthma patients (n = 78, mean age 11.8 ± 3.1 years) reported significantly more fatigue than Dutch peers (n = 328, mean age 11.8 ± 3.2 years) mean difference in z‐score: −0.68; 95%CI −0.96, −0.40. In the severe asthma group, 28.2% scored as "fatigued" and 15.4% as "severely fatigued," compared with 14.0% and 3.4% in the general population. In pediatric asthma patients, asthma‐related QoL (β = 0.77, p <.01, ΔR2 =.43), symptom control (β = 0.56, p <.01, ΔR2 =.24) and a dysfunctional breathing pattern (β = −0.36, p <.01, ΔR2 =.12) were most strongly associated with fatigue scores. Conclusion: Fatigue is a common symptom in children with severe asthma and is associated with multiple clinical factors and patient‐reported outcomes. It should be considered as an important treatment target. [ABSTRACT FROM AUTHOR]

Introduction: This study aimed to investigate how shared decision‐making (SDM) and the use of different types of outcome information are applied in routine care management for people with multiple sclerosis (MS) in an academic outpatient clinic. Methods: This qualitative study used the following: (a) observations of clinical encounters (N = 23) between patients and healthcare professionals (HCPs), (b) interviews with those patients (N = 17) and (c) interviews with those HCPs (N = 7). HCPs were not trained in SDM before the study. Audio recordings were transcribed literally. Transcriptions were analysed using qualitative thematic analysis. Results: Outcome information was hardly discussed with patients, apart from clinical outcome information at an individual level, such as MRI or lab results. This use of clinical outcome information did not automatically lead to a process of SDM. HCPs tended to implicitly present choices to patients after signalling and discussing 'problems'. In the interviews, patients indicated that they tended to consent to the advice given by HCPs and to prefer not too much change in treatment plans. However, they also emphasized the importance of being informed about available options with benefits and harms. We observed multiple discussions about patients' preferences, especially related to patients' experiences and priorities. Conclusions: Overall, SDM and the use of different types of outcome information did not seem to be enacted in routine care management for people with MS, mostly because choices were not explicitly mentioned or discussed. However, discussions about patients' experiences and priorities did take place. Training HCPs further and developing patient information seem reasonable steps to proceed. Patient or Public Contribution: People with MS contributed as research participants and provided us with their experiences in interviews. Furthermore, representatives of two patient organizations contributed to the study by reviewing the interview protocol for people with MS. [ABSTRACT FROM AUTHOR]

Background: This multicentre retrospective cohort study assessed whether functional outcomes after primary reverse shoulder arthroplasty (RSA) are favourable compared to secondary placement in elderly patients with displaced proximal humerus fractures (PHFs). Methods: Fifty-three patients with primary and 32 with secondary RSA were included. Patient-reported outcome measures (PROMs) were assessed: Constant–Murley Score (CMS), Oxford Shoulder Score (OSS), Disabilities of the Arm, Shoulder and Hand (DASH) score, and Visual Analogue Scale (VAS). In addition, range of motion (ROM) was compared between groups. Result: For PROMs, the means (SD) for primary versus secondary were 25.4 (17.7), 29.4 (19.2) for DASH; 38 (8.6), 38 (9.1) for OSS; 63 (19.8), 59 (22.0) for CMS and 2 (2.0), 3 (2.3) for VAS. For ROM, the means were the following: forward flexion 113° (33.6), 106° (34.1); abduction 103° (33.4), 96° (37.3) and external rotation 20° (19.1), 20° (17.8). There were significant differences in favour of primary treatment in forward flexion (p = 0.003, B 19.85) and abduction (p = 0.034, B 17.34). Discussion: ROM in patients with complex displaced PHFs after primary RSA is slightly better than that after secondary treatment. Therefore, RSA could be considered primary treatment, especially when optimal ROM is of great importance to the patient. Level of evidence: level III, retrospective comparative study treatment study [ABSTRACT FROM AUTHOR]

Introduction: Atopic dermatitis (AD) is a chronic inflammatory dermatosis that affects all age groups. The impact of AD on patients' lives could differ across generations. Understanding the differences in objective and subjective severity of AD between generations may support more personalized care for the AD patients. Thus, this study aimed to compare the clinical severity and subjective impact of AD between generation Z (GZ) and the millennial generation (MG). Materials and methods: We carried out a cross‐sectional observational study in patients diagnosed with moderate to severe AD born between 1993–2001 (GZ) and 1978–1992 (MG) who attended an AD specialist care unit for the first time. We collected severity indices evaluated by the dermatologist, such as the Eczema Area and Severity Index (EASI) or the Investigator Global Assessment (IGA), and severity scales that included patient assessment, such as the SCORing Atopic Dermatitis (SCORAD) or the Patient‐Oriented Eczema Measure (POEM). Results: A total of 73 patients were included, of which 56.2% (41/73) were women. 52.86% (37/73) of the patients belonged to the MG, and 43.8% (33/73) belonged to GZ. Patients belonging to GZ presented lower severity of their AD compared to the MG (EASI: 9.75 ± 11.68 vs. 16.63 ± 14.66; P < 0.05). However, their perception of disease severity was similar to the MG (SCORAD: 43.54 ± 28.99 vs. 32.98 ± 21.91; P = 0.96; POEM: 13.21 ± 8.98 vs. 15.48 ± 6.69; P = 0.14). Conclusions: GZ presents a higher subjective perception of severity than millennials. Understanding these generational disparities contributes to creating more effective treatment strategies and provides a more targeted approach to care that addresses each generational group's unique needs and expectations. [ABSTRACT FROM AUTHOR]

Objective: We sought to correlate the time lag between psoriatic arthritis (PsA) symptom onset and diagnosis to the likelihood and severity of depression, social impairment, and disease impact on quality of life. Methods: This cross-sectional study conducted by the National Psoriasis Foundation (NPF) surveyed individuals with PsA using patient-reported outcome measures. Results: The analysis cohort comprised 2,196 patients with PsA. Likelihood of depression progressively increased when time between PsA symptom onset and diagnosis was beyond six months (28.6% <6 months; 29.6% 7–12 months; 38.1% 13–24 months; 35.4% >2 years; p<0.01). Individuals with more than six months delay reported increasingly higher rates of experiencing moderate limitation in social participation (22.9% <6 months; 29.2% 7–12 months; 34.0% 13–24 months; 35.3% >2 years; p<0.001). Unacceptable PsA symptom rates (PsAID score >4) increased with time between PsA symptom onset and diagnosis (74.7% <6 months; 76.4% 7–12 months; 80.8% 13–24 months; 81.6% >2 years; p<0.05). These relationships persisted in body mass index (BMI) and age adjusted models. Limitations: The study only includes participants who were active members of the NPF, and all data was self-reported. Conclusion: Our results demonstrate that delays between PsA symptom onset and diagnosis that are greater than six months lead to increased likelihoods of depression, social disengagement, and impaired quality of life, and that longer delays lead to increasingly worse outcomes in these domains. [ABSTRACT FROM AUTHOR]

Background: The Knee Numeric-Entity Evaluation Score (KNEES-ACL) is a 41-item condition-specific patient-reported outcome measure (PROM) that was developed for patients with an anterior cruciate ligament (ACL) deficiency and patients after ACL reconstruction. This measure is intended to be used for longitudinal clinical studies. The KNEES-ACL has demonstrated face and content validity and superior responsiveness compared with other PROMs commonly used in patients with an ACL injury. However, this PROM was developed in Danish and has not been appropriately translated and culturally adapted into North American English. Purpose: To translate and culturally adapt the KNEES-ACL from Danish to North American English. Study Design: Cross-sectional study. Methods: Translation from Danish to English and cultural adaptation to a North American context were performed according to the dual panel method. First, the Danish KNEES-ACL was translated by a bilingual panel, which provided multiple English wording options for each item. Second, an English lay panel focus group was formed to determine the wording for each item that best reflected everyday spoken language. Finally, individual think-aloud cognitive interviews were conducted with patients after an ACL injury to evaluate the relevance, comprehensiveness, and comprehensibility of the PROM content and questions. Repeated modifications and testing were performed until a final English version of the KNEES-ACL was constructed. Results: Participants in the lay panel focus group were able to reach unanimous decisions for each of the 41 items. Further changes to 17 items were made after 8 think-aloud interviews with patients with ACL injuries at various time points to ensure that items were relevant and being interpreted consistently among different types of patients. The final KNEES-ACL consisted of 6 domains: Problems with Daily Activities, Mental Impact, Stability, Strength and Control, Pain, and Sport and Physical Activity. Conclusion: The English KNEES-ACL for patients with ACL injuries has undergone appropriate translation and cultural adaptation using established dual panel and cognitive interviewing methods in the population of interest. The psychometric properties of the English KNEES-ACL will likely mirror those established with the Danish version. However, direct validation of the psychometric properties of the English version would be beneficial before widespread use. [ABSTRACT FROM AUTHOR]

Background Prior studies showed that female patients with chronic rhinosinusitis (CRS) suffer a worse disease-specific quality of life (QoL). Goal The aim of this study is to investigate gender differences in sinonasal QoL outcomes in patients requiring endoscopic endonasal skull base surgeries (EESBS). Methods Cross-sectional analysis of patients presenting to our clinic from August 2020 to December 2022 with skull base tumors, spontaneous cerebrospinal fluid (CSF) rhinorrhea, or Grave's orbitopathy (for orbital decompression) was performed. Baseline and postsurgical QoL were measured using the 22-item Sinonasal Outcome Test (SNOT-22). Patients' demographics and comorbidities were reviewed. Patients with concomitant CRS were excluded. Results Eighty-six patients were included (54 with skull base tumors, 17 Grave's orbitopathy, and 15 spontaneous CSF rhinorrhea). The mean age of the patients was 52 years (range: 12.4–81.5 years), and 51.6% of the patients were females. There was no age difference between female and male patients. Smoking history, asthma, and allergic rhinitis were also similar between the two groups. Female patients had a significantly higher incidence of depression (58.3 vs. 32.4%, p = 0.018) and migraine (50.0 vs. 21.6%, p = 0.007). Female patients had a significantly worse overall SNOT-22 scores at baseline (33.6 vs. 18.2, p = 0.001), at the 3-month follow-up (29.7 vs. 15.5, p = 0.002), and at the 6-month follow-up (33.5 vs. 14.9, p = 0.005). This worse QoL was seen mainly in the ear/facial, sleep, and psychological domains. Linear regression of the SNOT-22 scores and its subdomains adjusting for comorbidities showed that migraine was found to be the most significant determinant of gender differences in the QoL. Conclusion Female patients who undergo EESBS show higher overall SNOT-22 scores secondary to higher incidence of migraine. [ABSTRACT FROM AUTHOR]

Aims: Research in diabetes‐related foot conditions (DRFC) often focuses on ulcer‐related care, whilst the patient experience and influence of sociodemographic factors are under‐researched. This systematic review investigated patient‐reported outcomes and experience in people with DRFC. Methods: Multiple databases were searched from inception to 16 August 2023. All original articles that assessed any patient‐reported outcome or experience in DRFC and reported participant ethnicity were included. Data were synthesized using a sequential contingent approach. Study quality was assessed using study design‐specific tools. Results: Twenty‐three studies were included (11 qualitative, 11 quantitative and one mixed‐methods). DRFC had a largely negative impact on various life dimensions, including social and daily life, work, emotional and psychological well‐being, necessitating dependence on others in the form of emotional, social and/or religious support, which were experienced differently by different groups. Patient DRFC knowledge and self‐care habits were typically suboptimal, and levels of hope and feeling of control over their condition varied between groups. Outcomes varied slightly between ethnicities across studies, with some ethnicity‐specific themes identified such as beliefs about disease cause and footwear habits. Quantitative and qualitative findings were mostly congruent. Conclusions: DRFC profoundly and negatively impacts patient‐reported outcomes and experience, with limited evidence suggesting an influence of ethnicity. [ABSTRACT FROM AUTHOR]

Simple Summary: This review explores the role of physiotherapy in early and traditional palliative care (PC) for cancer patients, focusing on its effects on patient-reported outcomes (PROMs) such as fatigue, pain, and quality of life (QoL). The findings suggest that certain physiotherapy interventions, like cognitive behavioral therapy (CBT) and massage, can improve these outcomes, while others show limited or no significant benefits. However, the overall quality of the studies reviewed was low, highlighting the need for more rigorous research in this area to better understand how physiotherapy can support patients in PC. Background: This review aims to explore the role of physiotherapy in early and traditional palliative care (PC) for oncology patients, focusing on its impact on six patient-reported outcomes (PROMs), namely fatigue, pain, cachexia, quality of life (QoL), physical functioning (PHF), and psychosocial functioning (PSF). The purpose is to assess the effectiveness of various physiotherapy interventions and identify gaps in the current research to understand their potential benefits in PC better. Methods: A systematic literature search was conducted across PubMed, Embase, and Web of Science, concluding on 21 December 2023. Two independent reviewers screened the articles for inclusion. The Cochrane Risk of Bias Tool 2 was employed to assess the risk of bias, while the GRADE approach was used to evaluate the certainty of the evidence. Results: Nine randomized controlled trials (RCTs) were included, with most showing a high risk of bias, particularly in outcome measurement and missing data. Cognitive behavioral therapy (CBT) was the only intervention that significantly reduced fatigue, enhanced PHF, and improved QoL and emotional functioning. Graded exercise therapy (GET) did not yield significant results. Combined interventions, such as education with problem-solving or nutritional counseling with physical activity, showed no significant effects. Massage significantly improved QoL and reduced pain, while physical application therapies were effective in pain reduction. Mindful breathing exercises (MBE) improved QoL but had a non-significant impact on appetite. The overall certainty of the evidence was low. Conclusions: Physiotherapy can positively influence PROMs in oncology PC; however, the low quality and high risk of bias in existing studies highlight the need for more rigorous research to confirm these findings and guide clinical practice. [ABSTRACT FROM AUTHOR]

Objectives ANCA-associated vasculitis (AAV) is associated with significant morbidity, fatigue, pain and poor health-related quality of life (HRQoL). This review aims to assess the comprehensiveness of existing patient reported outcome measures (PROMs) used in AAV and identify associations with poorer HRQoL outcomes. Methods A literature review of studies using PROMs, including those labelled HRQoL in people with AAV as a primary or secondary study outcome were screened and reviewed up to July 2023. Quality was assessed using the Critical Appraisal Skills Programme. Results A total of 30 articles were included which utilised 22 different PROM tools, 76.7% (n  = 23) used the SF-36 or a variation as a generic measure of health status and or HRQoL. Two studies developed a disease-specific PROM. The AAV-PRO showed good psychometric properties but potential limitations in capturing all relevant aspects of the disease experience for AAV patients. Factors associated with poorer HRQoL included: neurological and sinonasal involvement, women and younger patients. A total of 86.6% of studies showed no meaningful relationships between the SF-36 and BVAS, VDI or disease duration. Depression and anxiety were common and socioeconomic factors such as unemployment were significantly associated with poorer mental health outcomes. Glucocorticoids were found to be independently associated with worse SF-36 scores. Conclusion Generic PROMs are useful in measuring significant changes but lack sensitivity to specific symptoms and unique AAV-related issues, while existing disease-specific PROMs have some limitations and may not fully capture the AAV patient's perspective on disease and treatment burden. [ABSTRACT FROM AUTHOR]

Study Design. Retrospective analysis of prospectively collected data. Objective. To examine the combined influence of preoperative sleep disturbance and depression on 12-month patient-reported outcomes after lumbar spine surgery (LSS). Summary of Background Data. Psychological and behavioral factors are considered major risk factors for poor outcomes after LSS. However, there is a need to explore the combined effects of preoperative factors such as sleep disturbance and depression. Understanding the influence of sleep disturbance and depression can inform evidence-based preoperative assessment and shareddecision making of preoperative and postoperative treatment. Methods. Data from 700 patients undergoing LSS were analyzed. Preoperative sleep disturbance and depression were assessed with PROMIS subscales. Established thresholds defined patients with moderate/severe symptoms. Outcomes for disability (Oswestry Disability Index) and back and leg pain (Numeric Rating Scales) were assessed preoperatively and at 12 months. Separate multivariable linear regressions examined the influence of each factor on 12-month outcomes with and without accounting for the other and in combination as a 4-level variable: (1) moderate/severe sleep disturbance alone, (2) moderate/severe depression alone, (3) both moderate/severe sleep disturbance and depression, (4) no moderate/severe sleep disturbance or depression. Results. Preoperative sleep disturbance and depression were associated with 12-month disability and pain (P<0.05). After accounting for depression, preoperative sleep disturbance remained associated with disability, while preoperative depression adjusting for sleep disturbance remained associated with all outcomes (P<0.05). Patients reporting both moderate/severe sleep disturbance and moderate/severe depression had 12.6 points higher disability and 1.5 points higher back and leg pain compared with patients without moderate/severe sleep disturbance or depression. Conclusions. The combination of sleep disturbance and depression impacts postoperative outcomes considerably. The high-risk group of patients with moderate/severe sleep disturbance and depression could benefit from targeted treatment strategies. [ABSTRACT FROM AUTHOR]

Introduction: The electronic collection of patient data is used for a large variety of conditions. The boundaries of its use in initial diagnostics and the extent to which it can replace specialist contact, however, remain vague. Our newly developed virtual diagnostic process for common sleep disorders involves digital questionnaire administration, neurophysiological diagnostic studies, and virtual consultation with a sleep specialist. In this study, we evaluated patients' virtual diagnostic process experiences as part of a full evaluation of this process. Methods: Patients who completed the virtual diagnostic process participated in online semi-structured interviews based on the following criteria: age ≥ 18 years, no obvious cognitive deficits, and access to the internet. Patients who did not complete the virtual diagnostic process were contacted by telephone and given the opportunity to explain why. Results: Of the 24 patients included, 14 completed the virtual diagnostic process. Most participants understood the concept of the virtual diagnostic process, could navigate the process, and felt that the combined use of a questionnaire and virtual consultation was meaningful. Although participants could provide information as free text, the simplified closed questions, required for diagnostic classification, triggered feelings of insecurity and the inability to sufficiently describe symptoms, thereby evoking concern. All patients deemed the complementary personal contact important. Discussion: The findings demonstrate that the virtual diagnostic process is feasible and highly accepted by most patients. However, (virtual) personal (telephone or video) contact is mandatory to address patients' concerns. The virtual diagnostic process application evaluated here likely represents the outer limit of the use of electronic data collection in virtual diagnostic procedures. [ABSTRACT FROM AUTHOR]

The era of value-based health care is characterized by an increasing interest in patient-reported health outcomes. For this purpose we developed the rhinoplasty health care monitor (RHM), a streamlined outcome measurement protocol, including all rhinoplasty patients since 2014. Statistical analyses of patient-reported outcome data are automated and visually presented on a custom web-based dashboard. We describe the clinical and practical benefits of the RHM and discuss how routine prospective outcome measurements have upgraded our care standards. For this prospective study, 979 consecutive patients referred for functional (revision) rhinoplasty from April 2014 to August 2023 were included. Preoperative and 3- and 12-month postoperative scores on the Nasal Obstruction Symptom Evaluation scale (NOSE), Utrecht Questionnaire (UQ), and visual analog scales (VAS) were obtained. Of 979 referred patients, 599 (61.2%) were eligible for rhinoplasty. One year postoperatively, mean NOSE scale sum score improved from 69.1 ± 22.8 to 23.1 ± 23.5 (p < 0.001). Functional VAS scores improved from 4.1 ± 2.8 (left) and 4.1 ± 2.8 (right) to 7.5 ± 1.9 (left) and 7.3 ± 2.0 (right; p < 0.001). Mean UQ sum score improved from 12.0 ± 6.4 to 6.8 ± 3.3 and aesthetic VAS score improved from 4.5 ± 2.5 to 7.4 ± 1.7 (p < 0.001) 1 year postoperatively. Benefits of the outcome routine were improved patient selection, data-driven expectation management and patient empowerment, and targeted critical appraisals of surgical performance. In conclusion, routine, automated, prospective outcome monitoring provides physicians with a response to the increasing demand for data-driven insights in health outcomes. The limited effort that is needed to gather and monitor outcome data is heavily repaid by valuable insights into aspects of care that can be improved. [ABSTRACT FROM AUTHOR]

This study aimed to determine the clinical outcomes, predictors of suboptimal functional improvement, and factors influencing patient satisfaction following conversion of a fused hip to total hip arthroplasty (THA). A retrospective analysis of clinical and radiographic data was performed on 83 patients (83 hips) who underwent fused hip conversion to THA. Implant survival and predictors of poor functional outcome (Harris hip score < 70) were analyzed. In addition, factors associated with patient dissatisfaction (visual analog scale < 25th percentile) were analyzed in 63 patients (63 hips) who completed a patient-reported outcome measures questionnaire. The median Harris hip score improved from 55 (range, 18 to 77) to 78 (range, 36 to 100) at a mean follow-up of 10.2 ± 4.8 years (P <.001). Implant survival was 97.4% at 10 years and 91.3% at 20 years, with any revision as the endpoint. Multivariate analysis identified preoperative reliance on mobility aids as an independent predictor of poor functional outcome (P =.021). There were 48 of 63 patients (76%) satisfied (satisfaction visual analog scale ≥80) with the operated hip. Demographics and preoperative/postoperative clinical data did not differ between satisfied and unsatisfied patients. Among the patient-reported outcome measures, the Forgotten Joint Score-12 emerged as an independent discriminator of patient satisfaction. Conversion of a fused hip to THA provides functional improvement, favorable implant survival, and high patient satisfaction. However, patients dependent on mobility aids may experience suboptimal functional recovery, underscoring the need for careful preoperative counseling and patient selection. [ABSTRACT FROM AUTHOR]

Variations in defining poor response to total knee arthroplasty (TKA) impede comparisons of response after TKA over time and across hospitals. This study aimed to compare the prevalence, overlap, and discriminative accuracy of 15 definitions of poor response after TKA using 2 databases. Data of patients one year after primary TKA from the Dutch Arthroplasty Register (n = 12,275) and the Osteoarthritis Initiative database (n = 204) were used to examine the prevalence, overlap (estimated by Cohen's kappa), and discriminative accuracy (sensitivity, specificity, positive predictive value, negative predictive value, and Youden index) of 15 different definitions of poor response after TKA. In the absence of a gold standard for measuring poor response to TKA, the numeric rating scale satisfaction (≤ 6 'poor responder') and the global assessment of knee impact (dichotomized: ≥ 4 'poor responder') were used as anchors for assessing discriminative accuracy for the Dutch Arthroplasty Register and Osteoarthritis Initiative dataset, respectively. These anchors were chosen based on a prior qualitative study that identified (dis)satisfaction as a central theme of poor responses to TKA by patients and knee specialists. The median (25th to 75th percentile) prevalence of poor responders in the examined definitions was 18.5% (14.0 to 25.5%), and the median Cohen's kappa for the overlap between pairs of definitions was 0.41 (0.32 to 0.59). Median (25th to 75th percentile) sensitivity was 0.45 (0.39 to 0.54), specificity was 0.86 (0.82 to 0.94), positive predictive value was 0.45 (0.34 to 0.62), negative predictive value was 0.89 (0.87 to 0.89), and the Youden index was 0.36 (0.20 to 0.43). This study found a lack of overlap between different definitions of poor response to TKA. None of the examined definitions adequately classified poor responders to TKA. In contrast, the absence of a poor response could be classified with confidence. [ABSTRACT FROM AUTHOR]

The prevalence of reverse total shoulder arthroplasty (rTSA) has grown rapidly. As indications for the procedure expand, the proportion of patients who have satisfactory outcomes after rTSA has not been well defined. This systematic literature review explores overall patient satisfaction after rTSA and defines patient satisfaction based on indication for surgery. A literature search was performed for studies describing patient satisfaction after rTSA in accordance with Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines. Papers were included if they investigated patient satisfaction after rTSA at a minimum of 2-year follow-up. Data were collected on patient demographics, including age, gender, and body mass index. Follow-up duration, indication for surgery, and patient reported outcome measures relating to patient satisfaction were also recorded. There were a total of 5234 patients and 5288 shoulders from the 45 included studies. The overall study population was 61.2% female and the average age was 71.1 years (range 23-99). Satisfaction results were recorded at final follow-up, with average follow-up of 49.1 months (range 24-228). Overall patient satisfaction ranged from 77.7% to 87.8%, depending on patient satisfaction patient reported outcome measures. When stratified by diagnosis, patients with a diagnosis of glenohumeral osteoarthritis (GHOA) rated better satisfaction on all metrics when compared to patients with a diagnosis of cuff tear arthropathy or massive rotator cuff tear. This systematic review demonstrated that patients who undergo rTSA for either GHOA, cuff tear arthropathy, or massive rotator cuff tear are generally satisfied with their procedure, with the rate of satisfaction highest in GHOA. Focusing on patient satisfaction may provide the best overall assessment of health care quality in a very understandable and tangible form. Overall satisfaction rate is valuable information for patient education and can be utilized as part of effective surgical counseling. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study was to assess the potential value of patient-reported outcomes (PROs) of depression, fibromyalgia symptoms, and pain in predicting non-inflammatory vs. inflammatory diagnoses in rheumatology patients. Methods: This retrospective, single-center study evaluated electronic health record (EHR) data from adults who were seen for their first rheumatology consultation and subsequently received a diagnosis of an inflammatory (e.g., rheumatoid arthritis or spondyloarthritis) or non-inflammatory (e.g., osteoarthritis or fibromyalgia) condition. The PROs evaluated included depressive symptoms (Patient Health Questionnaire-2 [PHQ-2]), fibromyalgia symptom severity (FM SS), and pain. Results: A total of 3669 patients were evaluated, including patients with (n = 984; 26.82%) and without (n = 2685; 73.18%) inflammatory rheumatologic disease, of whom 141 (3.8%) had fibromyalgia. The non-inflammatory subgroup reported higher FM SS scores, and the inflammatory subgroup had higher pain and inflammatory markers. Bivariate models based on PHQ-2 and FM SS had a very low specificity (0.3%) for predicting non-inflammatory conditions, resulting in the misclassification of >99% of inflammatory cases. Adding pain, inflammatory markers, and other relevant EHR variables increased specificity but still resulted in a high level of misclassification. Conclusions: The PROs evaluated in this study are not suitable for predicting non-inflammatory vs. inflammatory rheumatologic disease, even when combined with other EHR variables. [ABSTRACT FROM AUTHOR]

Objectives To assess the use of a co-designed patient-reported outcome (PRO) clinical dashboard and estimate its impact on shared decision-making (SDM) and symptomatology in adults with advanced cancer or chronic kidney disease (CKD). Materials and Methods We developed a clinical PRO dashboard within the Northwestern Medicine Patient-Reported Outcomes system, enhanced through co-design involving 20 diverse constituents. Using a single-group, pretest-posttest design, we evaluated the dashboard's use among patients with advanced cancer or CKD between June 2020 and January 2022. Eligible patients had a visit with a participating clinician, completed at least two dashboard-eligible visits, and consented to follow-up surveys. PROs were collected 72 h prior to visits, including measures for chronic condition management self-efficacy, health-related quality of life (PROMIS measures), and SDM (collaboRATE). Responses were integrated into the EHR dashboard and accessible to clinicians and patients. Results We recruited 157 participants: 66 with advanced cancer and 91 with CKD. There were significant improvements in SDM from baseline, as assessed by collaboRATE scores. The proportion of participants reporting the highest level of SDM on every collaboRATE item increased by 15 percentage points from baseline to 3 months, and 17 points between baseline and 6-month follow-up. Additionally, there was a clinically meaningful decrease in anxiety levels over study period (T -score baseline: 53; 3-month: 52; 6-month: 50; P  < .001), with a standardized response mean (SRM) of −0.38 at 6 months. Discussion PRO clinical dashboards, developed and shared with patients, may enhance SDM and reduce anxiety among patients with advanced cancer and CKD. [ABSTRACT FROM AUTHOR]

Background The disabilities of arm, shoulder, and hand (DASH) questionnaire addresses the patient's disabilities and symptoms to evaluate the extent and the impact of injuries in the patient's daily-life activities. This study aims to develop a valid and reliable adaptation of DASH into the Kurdish language and culture (DASH-KU). Methods American Association of Orthopedic Surgeons Outcomes Committee guideline was used for the cross-cultural adaptation of DASH to the Kurdish version. This study was conducted at the Shahid Saifaddin consultation clinic in Sulaymaniyah, Iraq between April and October 2022. A total of 300 participants, who were included in the study using an available sampling method, completed the self-report DASH-KU questionnaire during two consecutive assessments with a 24-hour interval. Results The DASH-KU questionnaire demonstrated excellent internal consistency (Cronbach's α = 0.99) and test–retest reliability (intraclass correlation = 0.99). A strong correlation between DASH-KU scores and the patient-rated wrist/hand evaluation tool (r = 0.792) supported its construct validity. Bland–Altman plots showed good agreement between assessments with no floor (3%) or ceiling (0%) effects. Factor analysis found the scale had high adequacy (0.700) and significant sphericity (p < 0.001). The major factor explained 40% of variance with an eigenvalue of 13.14. Additionally, a five-item model explained 81.23% of DASH-KU variance, though responsiveness was suboptimal, possibly due to the short 24-hour interval between measurements. Conclusion Our results demonstrate that DASH-KU has excellent reliability and validity in identifying upper limb injuries, and the psychometric properties of DASH-KU were similar to its original version. [ABSTRACT FROM AUTHOR]

Background: Mastectomy skin flap necrosis (SFN) is common following nipple-sparing mastectomy (NSM), but studies on its quality-of-life (QOL) impact are limited. We examined patient-reported QOL and satisfaction after NSM with/without SFN utilizing the BREAST-Q patient-reported outcome measure (PROM) survey. Patients and Methods: Patients undergoing NSM between April 2018 and July 2021 at our institution were examined; the BREAST-Q PROM was administered preoperatively, and at 6 months and 1 year postoperatively. SFN extent/severity was documented at 2–3 weeks postoperatively; QOL and satisfaction domains were compared between patients with/without SFN. Results: A total of 573 NSMs in 333 patients were included, and 135 breasts in 82 patients developed SFN (24% superficial, 56% partial thickness, 16% full thickness). Patients with SFN reported significantly lower scores in the satisfaction with breasts (p = 0.032) and psychosocial QOL domains (p = 0.009) at 6 months versus those without SFN, with scores returning to baseline at 1 year in both domains. In the "physical well-being-of-the-chest" domain, there was an overall decline in scores among all patients; however, there were no significant differences at any time point between patients with or without SFN. Sexual well-being scores declined for patients with SFN compared with those without at 6 months and also at 1 year, but this did not reach significance (p = 0.13, p = 0.2, respectively). Conclusions: Patients undergoing NSM who developed SFN reported significantly lower satisfaction and psychosocial well-being scores at 6 months, which returned to baseline by 1 year. Physical well-being of the chest significantly declines after NSM regardless of SFN. Future studies with larger sample sizes and longer follow-up are needed to determine SFN's impact on long-term QOL. [ABSTRACT FROM AUTHOR]

Summary Avascular necrosis (AVN) is a prevalent and progressive complication in young patients with sickle cell disease (SCD), but no study evaluated the long‐term subjective and objective outcome measures. Oxford hip score (OHS) and Oxford shoulder scores (OSS) are validated joint‐specific patient‐reported outcome measures (PROMs). In this prospective multicentre study, 47 SCD patients with pre‐existing diagnosis of AVN occurred at a median age of 35.9 (24.2–47.6) filled out the OHS and OSS at median follow‐up of 9.4 years (4.5–12.9). No patient died after diagnosis of AVN. Hip AVN was present in 34 (72%) patients, with bilateral involvement in 25 (74%); 26 (59%) underwent total hip arthroplasty (THA) at a median age of 34.6 (22.6–49.5); and 4 (15%) required re‐surgery. OHS revealed moderate to severe impairment both in patients underwent THA and no hip surgery. Shoulder AVN was present in 13 (6%) patients and OSS revealed mild to moderate impairment. A high rate of compromised joint function and pain was observed 10 years after diagnosis of AVN regardless of the type of treatment, outlying the need to improve the management of this sickle‐related complication. OHS and OSS are validated joint‐specific PROMs easy to use in all SCD centres. [ABSTRACT FROM AUTHOR]

AbstractObjectiveMethodsResultsConclusions Trial registration\nPLAIN LANGUAGE SUMMARYWe report patient-reported outcomes (PROs) measuring health-related quality of life (HRQoL) from the ROSEWOOD trial (NCT03332017), which demonstrated superior efficacy and a manageable safety profile with zanubrutinib plus obinutuzumab (ZO) versus obinutuzumab (O) in patients with heavily pretreated relapsed/refractory follicular lymphoma (R/R FL).PROs were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30 (EORTC QLQ-C30) and EQ-5D-5L questionnaires at baseline and subsequently every 12 weeks. All QLQ-C30 domains and EQ-5D-5L visual analog scale (VAS) scores were analyzed descriptively. At the key clinical timepoints (weeks 12 and 24), a mixed model for repeated measures (MMRM) analysis was used to evaluate the key PRO endpoints, including global health status, physical and role functioning, and symptoms of fatigue, pain, diarrhea, and nausea/vomiting. Clinically meaningful change was defined as a ≥ 5-point mean difference from baseline and between the ZO and O arms.Patients were randomized to ZO (n = 145) or O (n = 72). By week 48, descriptive analysis results indicated that patients in the ZO arm demonstrated improved outcomes in role functioning and fatigue and nausea/vomiting symptoms, compared with those in the O arm. Both groups experienced improvements in pain symptoms. EQ-5D-5L VAS scores showed no observable differences between treatment arms through week 48. MMRM analysis revealed that the global health status/quality of life of patients treated with ZO improved, as did fatigue, at week 12. At week 24, patients in the ZO arm experienced a clinically meaningful improvement in role functioning, pain, and fatigue.In patients with R/R FL, ZO was associated with improved PROs compared with O. These findings suggest that zanubrutinib contributed clinically meaningful benefits to patient HRQoL when added to obinutuzumab.The ROSEWOOD trial is registered on ClinicalTrials.gov (BGB-3111-212; ClinicalTrials.gov identifier: NCT03332017).Follicular lymphoma (or FL) is a common blood cancer where abnormal white blood cells form lumps in organs and glands in the body that normally help fight infection (lymph nodes). Zanubrutinib selectively blocks Bruton tyrosine kinase, which can prevent cancer cells growing and lead to their death. Obinutuzumab binds to a protein called CD20 on cancer cells, facilitating their removal using the body’s natural defense system. Previous results from the ROSEWOOD trial showed that zanubrutinib plus obinutuzumab had improved cancer-fighting effects versus obinutuzumab alone, with manageable side effects in patients whose cancer returned after treatment or when treatment had failed. This study examined how these two cancer treatments impacted the patients’ wellbeing and day-to-day functioning as reported directly by them (patient-reported outcomes). Researchers found that by week 48 of the trial, patients who received zanubrutinib plus obinutuzumab found it easier to manage daily activities (role functioning) and had fewer symptoms of feeling exhausted all the time (fatigue) and nausea/vomiting versus those who received obinutuzumab alone. Further analysis showed that the patients who received zanubrutinib plus obinutuzumab had noticeable improvements from the start of treatment in role functioning, pain, and fatigue versus patients receiving obinutuzumab alone at week 24 of the trial. In conclusion, this study showed that zanubrutinib plus obinutuzumab was associated with improved patient-reported outcomes versus obinutuzumab alone in patients with relapsed or refractory FL. [ABSTRACT FROM AUTHOR]

Background: The relationship between the quality of inpatient versus outpatient obstetric postpartum recovery is under-explored. We examined the association between inpatient reported quality of recovery with outpatient global recovery, pain severity, pain interference, anxiety, and depression screening scores postpartum. Methods: We conducted a multicenter observational cohort study of women in labor who underwent vaginal, operative vaginal, or intrapartum cesarean birth. Subjects completed baseline assessments of pain, social support, anxiety, and depression in early labor. We assessed the Obstetric Quality of Recovery-10 (ObsQoR-10) on the day of discharge and the ObsQoR-10, Global Health Scale (GHVAS; 0–100), Brief Pain Inventory (BPI), and the Edinburgh Postnatal Depression Scale (EPDS) on postpartum day seven. We hypothesized that the ObsQoR-10 scores at discharge would be useful in predicting postpartum day seven measures of recovery and postpartum depression screening scores. Results: We consented 558 subjects, 551/558(98%) completed baseline assessments, 400/551(72%) completed the ObsQoR-10 tool, and 344/551(62%) completed an EPDS assessment. Median (1st, 3rd quartile) ObsQoR-10 scores were 78 (63, 90) at discharge and 85 (68,93) on postpartum day seven, (difference of 7 [99% CI 2 to 13], P < 0.001). GHVAS on postpartum day seven identified 204/344 (59%) of subjects with good recovery. An ObsQoR-10 score of > 86 at discharge had a RR of 1.5 [95% CI 1.2 to 1.8], P < 0.001 for good recovery at postpartum day seven, the EPDS identified 20/344 (5.8%) respondents with a score ≥ 13 on postpartum day seven. The area under the curve between the ObsQoR-10 at discharge with an EPDS ≥ 13 was 0.74 (99% CI 0.61 to 0.86, P < 0.001). The RR for an EPDS ≥ 13 on postpartum day seven with an ObsQoR-10 < 77 on the day of discharge was 7.8 (95% CI 1.8 to 33.8; P = 0.001). Conclusions: ObsQoR-10 scores at discharge and postpartum day seven demonstrated increased obstetric recovery in the post-discharge period. The observed association between the ObsQoR-10 and the EPDS, suggests that the ObsQoR-10 might facilitate identification of women at increased risk of postpartum anxiety or depression. Identification of high-risk women at discharge may allow early interventions to reduce morbidity secondary to postpartum depression. [ABSTRACT FROM AUTHOR]

Background: This study aimed to analyze the effect of cardiac rehabilitation programs on the health-related quality of life of patients after a coronary cardiac event using patient-reported outcome measures (PROMs) for up to 6 months of evaluation. Methods: A comprehensive search was carried out in the MEDLINE, CINAHL, CENTRAL, and Web of Science databases for randomized controlled trials comparing the cardiac rehabilitation program with usual care. Two independent reviewers assessed the studies for inclusion, risk of bias using the Cochrane tool, and quality of evidence through the GRADE system. A meta-analysis was performed on studies assessing health-related quality of life with the SF-12 (Physical Component Summary and Mental Component Summary) up to 6 months after the program. Results: Twelve studies encompassed 2260 patients who participated in a cardiac rehabilitation program after a coronary event, with a mean age of 60.06 years. The generic PROMs used to assess quality of life were the SF-12, SF-36, EQ-5D-3L, EQ-5D-5L, and GHQ, and the specific coronary heart disease PROMs were MacNew and HeartQoL. There was a positive effect of participation in cardiac rehabilitation on the physical component of health-related quality of life at 6 months (MD [7.02]; p = 0.04] and on the mental component (MD [1.06]; p = 0.82) after applying the SF-12. Conclusions: This study highlights the significant benefits of cardiac rehabilitation programs on health-related quality of life, particularly in the physical domain at 6 months. Assessing outcomes over time through PROMs after coronary heart events is essential, thus making it possible to personalize patients' care and improve their health status. [ABSTRACT FROM AUTHOR]

Background: Acute rhinosinusitis (ARS) is a self-limiting inflammation of the nose and sinuses caused by viral or bacterial infections that requires primarily symptomatic treatment. Patient-reported outcome measures (PROMs) are suitable tools for the assessment of the effectiveness of remedies for ARS from the patient's perspective in clinical trials and real-world studies. Data regarding the quality of existing PROMs for ARS are limited. Purpose: To conduct a systematic review of the quality of existing disease-specific PROMs for use in adults and children with ARS according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology, and to derive recommendations for use of the identified instruments in future clinical studies. Methods: We systematically searched PubMed, Web of Science and Embase for studies reporting on the development and/or validation of PROMs for ARS. We assessed the methodological quality of each included study, evaluated the quality of measurement properties per PROM and study, and graded the evidence. Based on the overall evidence, we derived recommendations for use of the instruments. Results: We identified four studies on three PROMs measuring symptoms of ARS and quality of life in adults (Sinonasal Outcome Test-16, SNOT-16; Measurement of Acute Rhinosinusitis, MARS; Rhinosinusitis Quality-of-Life Assessment, RhinoQoL). For ARS in children, we identified two studies on two PROMs measuring symptoms of ARS (Pediatric Rhinosinusitis Symptom Scale, PRSS; Sinus Symptom Questionnaire, S5). Our assessment of measurement properties indicates that all instruments require further validation before they can be unrestrictedly recommended for use in future research (COSMIN category B). In particular, there were no content validity studies for any of the identified instruments, but also data on other important measurement properties, e.g., structural validity, are lacking. Conclusion: Currently, no PROM for ARS in adults and children can be unrestrictedly recommended based on the evaluation of their quality. Further validation is required for all identified PROMs. Content validation involving patients and experts should be given priority. Systematic review registration: OSF (https://doi.org/10.17605/OSF.IO/VAP8U). [ABSTRACT FROM AUTHOR]

Background: N-methyl-D-aspartate-receptor (NMDAR) encephalitis is a rare neurological autoimmune disease with severe neuropsychiatric symptoms during the acute phase. Despite good functional neurological recovery, most patients continue to experience cognitive, psychiatric, psychological, and social impairments years after the acute phase. However, the precise nature and evolving patterns over time of these long-term consequences remain unclear, and their implications for the well-being and quality of life of predominantly young patients have yet to be thoroughly examined. Methods: SAPIENCE is a European multi-center (n = 3) prospective observational cohort study studying the long-term cognitive, psychiatric, psychological, and social outcome in patients with NMDAR encephalitis. The study consists of three interconnected levels. Level 1 comprises a qualitative interview and focus groups with patients and their caregivers. Level 2 consists of a condensed form of the interview, standardized questionnaires, and a detailed neuropsychological examination of patients. Level 3 involves an online survey that will be open to patients world-wide and explores patient-reported outcomes (PROMs), and patient-reported experiences (PREMs) in association with clinical and cognitive outcomes. Levels 1 to 3 will progressively contribute developing of structured interviews, survey questions, and treatment guidelines by informing one another. Discussion: SAPIENCE is an in-depth study of the long-term effects of NMDAR encephalitis and bridges the gap between standardized assessments and individual patient experiences, intending to improve patient care and to increase awareness of the psychosocial long-term consequences of the disease. Through collaboration of experts in clinical neurology and social and health psychology across Europe, SAPIENCE aims to create online assessment tools and formulate guidelines for patient-centered post-acute care that will help enhance the quality of life for patients and caregivers. [ABSTRACT FROM AUTHOR]

Introduction Aim Methods Results Conclusions Currently, no quality‐of‐life instrument exists that captures the full experience of the mental health outlook (MHO), a coreHEM core outcome, in people with haemophilia, including the potential transformational experience of receiving gene therapy.To describe the methods used to develop a content validated patient‐reported outcome measure (PROM) that measures MHO for people with haemophilia.A conceptual framework, developed from a literature/evidence review, was used to create an interview guide and draft a questionnaire. Males aged 15 or older with severe/moderate haemophilia were eligible to participate in concept elicitation or cognitive debriefing interviews. The conceptual framework was refined based on a thematic analysis of concept elicitation interviews and PROM items were developed from the conceptual framework. Cognitive debriefing sessions that prioritised relevance and understanding of the PROM were held in two rounds; items were updated iteratively.A conceptual framework with five domains (stigma, anxiety, depression, life interference and identity) was constructed from over 300 identified MHO concepts. Fifty‐three participants took part in interviews. After 32 concept elicitation interviews, the framework was updated by including eight new sub‐concepts and eliminating two. Updates to the questionnaire included items added or removed and improved wording. The final coreHEM MHO PROM has 26 questions in two sections (general mental health associated with haemophilia, and a gene therapy section).The instrument is content‐validated and can be used as an exploratory outcome. MHO scores can be measured and compared to give more insight into patient quality of life. [ABSTRACT FROM AUTHOR]

Background and purpose Methods Results Conclusions There are concerns for safety regarding SARS‐CoV‐2 vaccines for patients with autoimmune neuromuscular disease. We compared daily functioning using disease‐specific patient‐reported outcome measures (PROMs) before and after SARS‐CoV‐2 vaccinations.In this substudy of a prospective observational cohort study (Target‐to‐B!), patients with myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), multifocal motor neuropathy (MMN), and idiopathic inflammatory myopathy (IIM) vaccinated against SARS‐CoV‐2 were included. Surveys of daily functioning (Myasthenia Gravis Activities of Daily Living, Inflammatory Rasch‐Built Overall Disability Scale, Multifocal Motor Neuropathy Rasch‐Built Overall Disability Scale, and Health Assessment Questionnaire–Disability Index) were sent before first vaccination and every 60 days thereafter for up to 12 months. Regression models were constructed to assess differences in PROM scores related to vaccination, compared to scores unrelated to vaccination. We also assessed the proportion of patients with deterioration of at least the minimal clinically important difference (MCID) between before first vaccination and 60 days thereafter.We included 325 patients (median age = 59 years, interquartile range = 47–67, 156 [48%] female sex), of whom 137 (42%) had MG, 79 (24%) had CIDP, 43 (13%) had MMN, and 66 (20%) had IIM. PROM scores related to vaccination did not differ from scores unrelated to vaccination. In paired PROMs, MCID for deterioration was observed in three of 49 (6%) MG patients, of whom none reported a treatment change. In CIDP, MCID for deterioration was observed in eight of 29 patients (28%), of whom two of eight (25%) reported a treatment change.SARS‐CoV‐2 vaccination had no effect on daily functioning in patients with autoimmune neuromuscular diseases, confirming its safety in these patients. [ABSTRACT FROM AUTHOR]