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This study investigated self-reported clinically relevant cognitive impairment of breast cancer patients in routine clinical care and assessed factors associated with new-onset clinically relevant cognitive impairment. Cognitive functioning was assessed before start of any treatment (T0) and at 6 (T6) and 12 (T12) months after diagnosis. Cognitive functioning (CF) was measured on a scale of 0–100 with the EORTC QLQ-C30 questionnaire, and the EORTC pre-defined threshold for clinical importance. Multivariable logistic regression analyses was used to identify factors associated with new-onset clinically relevant cognitive impairment at T6 ((CF > 75 at T0 and CF < 75 at T6 and T12) or (CF > 75 at T0 and T6 and <75 at T12)). Pre-treatment, 21% of patients reported clinically relevant cognitive impairment. At T12, percentage was 32%; 20% of patients reported new-onset clinically relevant cognitive impairment at T6 and/or T12. New-onset clinically relevant cognitive impairment was associated with chemo(immuno)therapy and impairment in role and emotional functioning. Younger patients and patients receiving chemo(immuno)therapy were more likely to report new-onset clinically relevant cognitive impairment post treatment. One in five breast cancer patients reported clinically relevant cognitive problems before start of treatment. This percentage further increased within the first year, particularly among patients treated with chemo(immuno)therapy. One in five patients reported new-onset clinically relevant cognitive impairment. Ultimately, these patients may benefit from systematic monitoring and potential referral to interventions. • One in five patients report new-onset clinically relevant cognitive impairment within the first year after breast cancer diagnosis. • Patients with new-onset cognitive impairment are younger and often treated with chemo(immuno)therapy compared to patients without impairment. • Role and emotional functioning are associated with new-onset clinically relevant cognitive impairment. • Patients with cognitive impairment may benefit from systematic monitoring and potential referral to interventions. [ABSTRACT FROM AUTHOR]

Background: There are three patient reported outcome measure instruments (PROMs) that have adequate content validity for breast reconstruction, BREAST-Q, BRECON-31 and EORTC QLQ-BRECON-23, and they all have been robustly validated. The aim of this study was to systematically review scores giving meaning to validated PROMs for breast reconstruction after mastectomy and discuss methods to enable interpretation of them. Methods: A systematic review was performed according to the recommendations of PRISMA. Prospero CRD42021255874. Included articles had to meet criteria defined in a SPIDER (Sample, Phenomenon of Interest, Design, Evaluation, Research type). The included studies were critically appraised using the GRADE approach. Results: Three articles were finally included in the review: two studies on scores for healthy controls and one on minimally important differences (MIDs), both of BREAST-Q. All of the studies were performed in North America. Only MIDs based on statistical characteristics, and not on what constitutes a relevant change for the patient, exist. The risk of bias was evaluated as very high and moderate, respectively, of inconsistencies as low, of indirectness as high, of imprecisions as low, and of publication bias as probably low. Conclusions: The overall certainty of evidence for scores giving meaning to PROMs for breast reconstruction is low (GRADE ƟƟОО). More studies are needed to establish relevant healthy control scores and what constitutes a relevant clinical difference for patient-reported outcome measures for breast reconstruction after mastectomy. Clinical implications of the findings and suggestions for further research are suggested in the article.

Background/purpose: No studies have comprehensively assessed short-term patient-reported outcomes after the provision of overdentures supported by two immediate implants. The purpose of this study was to evaluate short-term patient-reported outcomes for mandibular overdentures retained by ball attachments on two immediately loaded implants. Materials and methods: Nineteen participants with mandibular edentulism were provided with overdentures retained by ball attachments on two immediately loaded, unsplinted implants. The participants' self-assessment of their dentures and oral health-related quality of life were evaluated with the 22-item Patient's Denture Assessment (PDA), and the 19-item Japanese version of the Oral Health Impact Profile (OHIP-EDENT), respectively. Patient satisfaction was measured on a 100 mm visual analogue scale. Assessments were conducted at baseline, and at 1 and 6 months after implant surgery. Results: There were significant increases in the PDA “Lower denture” (P = 0.009) at 1 month, as well as “Function” (P = 0.002) and “Lower denture” (P = 0.009) scores at 6 months. Patient satisfaction was also significantly increased at 1 month (P = 0.007) and 6 months (P ≤ 0.000). Significant decreases were observed in the OHIP-EDENT “Physical pain” (P = 0.046) score at 1 month, as well as the summary score (P = 0.033), “Functional limitation” (P = 0.020) and “Psychological discomfort” (P = 0.019) scores at 6 months. Conclusion: The use of two immediately loaded implants for lower mandibular complete overdentures is associated with improvements in patient's self-assessment of dentures, satisfaction, and oral health-related quality of life, up to 6 months after implant surgery.

BackgroundAlbeit the need for sex-disaggregated results of adverse events after immunization (AEFIs) is gaining attention since the COVID-19 pandemic, studies with emphasis on sexual dimorphism in response to COVID-19 vaccination are relatively scarce. This prospective cohort study aimed to assess differences in the incidence and course of reported AEFIs after COVID-19 vaccination between males and females in the Netherlands and provides a summary of sex-disaggregated outcomes in published literature.MethodsPatient reported outcomes of AEFIs over a six month period following the first vaccination with BioNTech-Pfizer, AstraZeneca, Moderna or the Johnson&Johnson vaccine were collected in a Cohort Event Monitoring study. Logistic regression was used to assess differences in incidence of ‘any AEFI’, local reactions and the top ten most reported AEFIs between the sexes. Effects of age, vaccine brand, comorbidities, prior COVID-19 infection and the use of antipyretic drugs were analyzed as well. Also, time-to-onset, time-to-recovery and perceived burden of AEFIs was compared between the sexes. Third, a literature review was done to retrieve sex-disaggregated outcomes of COVID-19 vaccination.ResultsThe cohort included 27,540 vaccinees (38.5% males). Females showed around two-fold higher odds of having any AEFI as compared to males with most pronounced differences after the first dose and for nausea and injection site inflammation. Age was inversely associated with AEFI incidence, whereas a prior COVID-19 infection, the use of antipyretic drugs and several comorbidities were positively associated. The perceived burden of AEFIs and time-to-recovery were slightly higher in females.DiscussionThe results of this large cohort study correspond to existing evidence and contribute to the knowledge gain necessary to disentangle the magnitude of the effect sex in response to vaccination. Whilst females have a significant higher probability of experiencing an AEFI than males, we observed that the course and burden is only to a minor extent different between the sexes.

ObjectiveTo identify and assess patient motivation to initiate or maintain behavior changes.MethodsAttitudinal statements were developed from structured patient interviews and translated into 18 survey items. Items were analyzed with exploratory factor analysis (EFA).ResultsAn EFA with 340 type 2 diabetes patients identified three areas of patient attitudes toward changing health behaviors: (1) willingness to make changes (3 items; α = 0.69), (2) perceived ability to make or maintain changes (3 items; α = 0.74), and (3) and feeling changes are worthwhile (3 items; α = 0.61). Greater perceived ability and feelings of worthwhileness were associated with positive psychosocial and behavioral management indicators. All three areas were associated with confidence and attitudes toward making a specific behavioral change (e.g., improve diet).ConclusionsMATCH is an internally consistent and valid 9-item scale that provides a profile of factors influencing motivation that can be used in clinical and research settings.

Abstract Background Power bursts of hips and ankle plantar flexors are prerequisites to walking propulsion. However, these power bursts are reduced during gait for persons with cerebral palsy (CP) and mainly in the ankle plantar flexors. Hence, task specific training, such as ballistic strength training, is suggested to increase muscle power in walking but not investigated in adults with CP. Therefore, the aim was to investigate if adults with CP could perform and benefit from ballistic strength training to improve walking, evaluated through physical measures and self-reported measures and interviews. Methods In this mixed methods feasibility study, eight ambulatory adults (aged 24–56) with spastic CP conducted ballistic strength training on a glideboard targeting the ankle plantarflexors two times a week for eight weeks. The feasibility of the training was assessed through objectives described by Orsmond and Cohn. Before and after the intervention, physical measures (6-Minute Walk Test and the eight-item High-level Mobility Assessment Tool) and self-reported measures (Patient Global Impression of Change, Numeric Pain Rating Scale, Fatigue Impact and Severity Self-Assessment, and Walk-12) were collected. After the intervention, semi-structured interviews explored experiences of this training. Results The participants experienced training the ankle plantar flexor as relevant but reported it took about four weeks to coordinate the exercises successfully. Although we observed no changes in the physical performance measures, most participants reported improvements; some felt steadier when standing, walking, and hopping. Conclusion This study demonstrated that ballistic strength training was feasible and suitable in adults with CP. However, guidance and a long (4 weeks) familiarization time were reported necessary to master the exercises. Most participants reported self-experienced improvements, although no physical performance measures improved. Thus, prolonged intervention may be required for perceived physical improvements to emerge. Also, other outcome measures sensitive to power output remains to be investigated.

Objective: Health economic comparisons of various therapies are often based on health-related quality of life (HRQOL) using EQ-5D questionnaires within the framework of clinical trials. This real-world study prospectively evaluates the patient reported outcomes (PROs)-based HRQOL of head-and-neck (H&N) cancer patients undergoing modern radiotherapy (RT) to reflect PRO trajectories.Methods: All H&N cancer patients treated in our clinic between July 2019 and December 2020 who completed the self-reported validated EQ-5D-5L questionnaire (health state index (HI) and Visual Analog Scale (VAS)) at baseline, end of radiotherapy, and at each respective follow up (FU) were included. Descriptive analysis of clinical and sociodemographic data, the frequency and level of each dimension was conducted. To assess the significance of therapy-induced HRQOL changes within and between the group, a distribution-based approach was used.Results: Altogether, 366 participants completed a total of 565 questionnaires. For the whole cohort, HI at baseline was 0.804 (±0.208), 0.830 (±0.162) at RT completion, 0.812 (±0.205) at the first follow-up, and 0.769 (±0.224) at the second follow-up. The respective VAS values were 62.06 (±23,94), 66.73 (±82.20), 63.30 (±22.74), and 65.48 (±23.39). Females showed significantly lower HI values compared to males, but only at baseline (p = 0.034). Significantly lower HI values were also seen in patients with definitive RT as compared to adjuvant RT at baseline (p = 0.023), the second follow-up (p = 0.047), and the third follow-up (p = 0.010). As compared to outpatients, inpatients had significantly lower HI values at RT completion (p = 0.017), the second follow-up (p = 0.007), and the third follow-up (p = 0.031). Subgroup analyses by age (< 65 vs. ≥65) and smoking status (smokers vs. non-smokers) showed no difference at any time point.Conclusion: PROs demonstrated detectability of time- and intra-/inter-group therapy-induced HRQOL changes. A further detailed exploration of EQ-5D-5L responsiveness for H&N cancer patients is required. [ABSTRACT FROM AUTHOR]

Background and Aims Management of inflammatory bowel disease [IBD] is complex and IBD Comprehensive Care Units [ICCUs] facilitate the delivery of quality care to IBD patients. The objective of this study was to update the existing set of quality indicators [QIs] for ICCUs, based on a nationwide quality certification programme carried out in Spain, from a multi-stakeholder perspective and using multicriteria decision analysis [MCDA] methodology. Methods An MCDA comprising three different phases was conducted. In phase 1, a systematic literature review was performed, and after validation by a scientific committee comprising 11 experts, a preliminary set of QIs was developed. In phase 2, a larger group of 49 experts determined the relevance and relative importance of each QI by prioritising and weighing the preliminary set. Finally in phase 3, the scientific committee reviewed the results and made a final selection via a deliberative process. Results The final set comprised 67 QIs, classified as Structure [23 QIs], Process [35 QIs] and Outcome [9 QIs], which were ranked according to their relative importance. Multidisciplinary management was the most important requirement in ICCUs, followed by continuity of care, standardisation of clinical care and, especially, the incorporation of patients' reported outcomes. Conclusions This updated set of QIs comprises a weighted and prioritised set of items that represent the essential minimum of criteria for ensuring appropriate quality of care in the management of IBD patients. [ABSTRACT FROM AUTHOR]

Objective: The Norwegian pancreatic cancer disease impact score (PACADI) is a digitalized analogue questionnaire that assesses different disease-specific symptoms. There is a need of translations of it into other languages. Therefore, the aim of this article is to describe the translation process of a Swedish version of PACADI and present its validity to EORCT QLQ PAN26. The self-administered questionnaire PACADI was translated according to guidelines and assessed by an expert panel of health care personnel. The test of its validity was performed with the disease-specific questionnaire for EORCT QLQ PAN26. Both questionnaires were completed by 66 subjects with pancreatic cancer, either before, at discharge or three months after surgery. Result: The results between the groups indicate that patients suffer from different symptoms at different times. The correlations between the different symptoms of the two questionnaires were fair to good. In conclusion, PACADI and QLQ PAN 26 have a good correlation and PACADI can be used in clinical practise. [ABSTRACT FROM AUTHOR]

Background: Early detection of Alzheimer's disease and related dementias (ADRD) in a primary care setting is challenging due to time constraints and stigma. The implementation of scalable, sustainable, and patient-driven processes may improve early detection of ADRD; however, there are competing approaches; information may be obtained either directly from a patient (e.g., through a questionnaire) or passively using electronic health record (EHR) data. In this study, we aim to identify the benefit of a combined approach using a pragmatic cluster-randomized clinical trial.Methods: We have developed a Passive Digital Marker (PDM), based on machine learning algorithms applied to EHR data, and paired it with a patient-reported outcome (the Quick Dementia Rating Scale or QDRS) to rapidly share an identified risk of impairment to a patient's physician. Clinics in both south Florida and Indiana will be randomly assigned to one of three study arms: 1200 patients in each of the two populations will be administered either the PDM, the PDM with the QDRS, or neither, for a total of 7200 patients across all clinics and populations. Both incidence of ADRD diagnosis and acceptance into ADRD diagnostic work-up regimens is hypothesized to increase when patients are administered both the PDM and QDRS. Physicians performing the work-up regimens will be blind to the study arm of the patient.Discussion: This study aims to test the accuracy and effectiveness of the two scalable approaches (PDM and QDRS) for the early detection of ADRD among older adults attending primary care practices. The data obtained in this study may lead to national early detection and management program for ADRD as an efficient and beneficial method of reducing the current and future burden of ADRD, as well as improving the annual rate of newly documented ADRD in primary care practices.Trial Registration: ClinicalTrials.gov Identifier: NCT05231954 . Registered February 9, 2022. [ABSTRACT FROM AUTHOR]

Introduction: The Knowledge of Genome Sequencing (KOGS) questionnaire was recently developed to measure knowledge of genomic sequencing (GS), with preliminary psychometric data supporting its reliability and validity. The aim of this study was to test the reliability and validity of the KOGS in a larger sample, and to confirm its utility in a cancer setting.Methods: The Genetic Cancer Risk in the Young (RisC) study recruits participants with a personal history of cancer, to investigate heritable cancer causes and future cancer risk using germline GS. Participants (n = 261) in a psychosocial substudy of RisC completed a questionnaire after consent to RisC but before GS, including the KOGS, the Intolerance of Uncertainty Scale, the Chew health literacy scale and items assessing demographic and disease variables. Confirmatory factor analysis (CFA), Cronbach alpha and correlational analyses were undertaken.Results: The CFA testing a single-factor model yielded a good model fit, χ2/df = 2.43, comparative fit index (CFI) = 0.97, root mean square error of approximation (RMSEA) = 0.07 and weighted mean root square (WRMR) = 1.03. Factor loadings of all items were above 0.60 and ranged between.66 and.93. The single factor score demonstrated excellent internal consistency (α = 0.82). KOGS scores were significantly associated with health literacy (r = 0.23, p < .001), having a university education [t(258) = -4.53, p < .001] and having a medical or science background [t(259) = -3.52, p < .001] but not with speaking a language other than English at home, time since diagnosis, previous genetic counselling/testing or intolerance of uncertainty.Discussion: This study confirmed a single-factor structure for the KOGS, and its reliability and validity in a cancer population. Associations with measures of health literacy and education were significant and positive as expected, supporting the KOG's construct validity. Previous genetic counselling may not be sufficient to provide specific knowledge of GS. [ABSTRACT FROM AUTHOR]

Increased exposure to ultraviolet radiation (UVR) is associated with an increased risk of nonmelanoma skin cancer. Cutaneous surgery can be negatively influenced by UVR, causing delayed wound healing, hyperpigmentation of the scar, and an increased incidence of additional skin cancers. By changing sun protection behavior, these risks can be limited. Therefore, this study evaluates changes in patients' sun protective behavior after Mohs micrographic surgery (MMS). Patients undergoing MMS between December 2017 and November 2019 were included. Patients were asked to complete the FACE-Q Skin Cancer - Sun Protection Behavior checklist before and 3 months and 1 year post-surgery. A total of 125 patients completed the pre-operative and 3-months post-operative checklists, and 89 (71.2%) completed the 1-year post-operative checklist. Reported sun protective behaviors increased post-surgery at all time points (p < 0.001). Patients with a prior history of facial skin cancer demonstrated a larger increase in sun protection behaviors after surgery than patients without a history of facial skin cancer (p = 0.04). Patients with defects located on the ear or scalp demonstrated a lesser increase in sun protection behaviors than patients with defects located in more conspicuous areas as the face (p = 0.02). Our study demonstrates a change in sun protection behavior, with an increase in sun protection behavior over time in patients after MMS. However, more improvement is possible. Targeted counseling can increase sun protection behavior in patients without a history of facial skin cancer and patients with skin cancer located on the ears or scalp. [ABSTRACT FROM AUTHOR]

Background: Clinical trials demonstrate the efficacy and tolerability of medications targeting calcitonin gene-related peptide (CGRP) signaling for migraine prevention. However, these trials may not accurately reflect the real-world experiences of more diverse and heterogeneous patient populations, who often have higher disease burden and more comorbidities. Therefore, postmarketing safety surveillance is warranted. Regulatory organizations encourage marketing authorization holders to screen digital media for suspected adverse reactions, applying the same requirements as for spontaneous reports. Real-world data from social media platforms constitute a potential venue to capture diverse patient experiences and help detect treatment-related adverse events. However, while social media holds promise for this purpose, its use in pharmacovigilance is still in its early stages. Computational linguistics, which involves the automatic manipulation and quantitative analysis of oral or written language, offers a potential method for exploring this content., Objective: This study aims to characterize adverse events related to monoclonal antibodies targeting CGRP signaling on Reddit, a large online social media forum, by using computational linguistics., Methods: We examined differences in word frequencies from medication-related posts on the Reddit subforum r/Migraine over a 10-year period (2010-2020) using computational linguistics. The study had 2 phases: a validation phase and an application phase. In the validation phase, we compared posts about propranolol and topiramate, as well as posts about each medication against randomly selected posts, to identify known and expected adverse events. In the application phase, we analyzed posts discussing 2 monoclonal antibodies targeting CGRP signaling-erenumab and fremanezumab-to identify potential adverse events for these medications., Results: From 22,467 Reddit r/Migraine posts, we extracted 402 (2%) propranolol posts, 1423 (6.33%) topiramate posts, 468 (2.08%) erenumab posts, and 73 (0.32%) fremanezumab posts. Comparing topiramate against propranolol identified several expected adverse events, for example, "appetite," "weight," "taste," "foggy," "forgetful," and "dizziness." Comparing erenumab against a random selection of terms identified "constipation" as a recurring keyword. Comparing erenumab against fremanezumab identified "constipation," "depression," "vomiting," and "muscle" as keywords. No adverse events were identified for fremanezumab., Conclusions: The validation phase of our study accurately identified common adverse events for oral migraine preventive medications. For example, typical adverse events such as "appetite" and "dizziness" were mentioned in posts about topiramate. When we applied this methodology to monoclonal antibodies targeting CGRP or its receptor-fremanezumab and erenumab, respectively-we found no definite adverse events for fremanezumab. However, notable flagged words for erenumab included "constipation," "depression," and "vomiting." In conclusion, computational linguistics applied to social media may help identify potential adverse events for novel therapeutics. While social media data show promise for pharmacovigilance, further work is needed to improve its reliability and usability., (©Pengfei Zhang, Brad K Kamitaki, Thien Phu Do. Originally published in JMIR Formative Research (https://formative.jmir.org), 08.11.2024.)

Background: The algorithmic patient preference predictor (PPP) has been proposed to aid in decision making for incapacitated patients in the absence of advanced directives. Ethical and legal challenges aside, multiple practical barriers exist for building a personalized PPP. Here, we examine previous work using machine learning to predict patient reported outcome measures (PROMs) for capacitated patients undergoing diverse procedures, therapies, and life events. Demonstrating robust performance in predicting PROMs for capacitated patients could suggest opportunities for developing a model tailored to incapacitated ones., Methods: We performed a scoping review of PubMed, Embase, and Scopus using the PRISMA-ScR guidelines to capture studies using machine learning to predict PROMs following a medical event alongside qualitative studies exploring a theoretical PPP., Results: Sixty-eight studies used machine learning to evaluate PROMs; an additional 20 studies focused on a theoretical PPP. For PROMs, orthopedic surgeries ( n = 33) and spinal surgeries ( n = 12) were the most common medical event. Studies used demographic ( n = 30), pre-event PROMs ( n = 52), comorbidities ( n = 29), social determinants of health ( n = 30), and intraoperative variables ( n = 124) as predictors. Thirty-four different PROMs were used as the target outcome. Evaluation metrics varied by task, but performance was overall poor to moderate for the best reported scores. In models that used feature importance, pre-event PROMs were the most predictive of post-event PROMs. Fairness assessments were rare ( n = 6). These findings reinforce the necessity of the integrating patient values and preferences, beyond demographic factors, to improve the development of personalized PPP models for incapacitated patients., Conclusion: The primary objective of a PPP is to estimate patient-reported quality of life following an intervention. Use of machine learning to predict PROMs for capacitated patients introduces challenges and opportunities for building a personalized PPP for incapacitated patients without advanced directives., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Balch, Chatham, Hong, Manganiello, Baskaran, Bihorac, Shickel, Moseley and Loftus.)

Objectives: The aim of this study was to validate the Patient self-Assessment of Skin Thickness in Upper Limb questionnaire (PASTUL) in systemic sclerosis (SSc) and assess impact of skin involvement on health-related quality of life (HRQoL)., Methods: Participants were included in four UK centres. PASTUL specifies a grading of skin at 8 sites corresponding to the modified Rodnan Skin Score (mRSS). Construct validity was assessed by comparing PASTUL scores with mRSS. HRQoL was evaluated with EQ5D5L and Leeds SSc HRQoL questionnaires. Additionally, correlation between PASTUL and Scleroderma Skin Patient reported Outcome (SSPRO) was explored. Follow-up was 12 months., Results: In total, 196 participants were included, mean age was 56.4 years (SD 13.9), 80.6% female (n = 158), mean disease duration 11.9 years (SD 9.9), 110 (56.1%) had limited cutaneous (lcSSc) and 81 (41.3%) diffuse cutaneous SSc (dcSSc). PASTUL and upper limb mRSS were well correlated at baseline, 6 and 12 months (ICC = 0.67, 0.78 and 0.62, p< 0.001). Test-retest reliability was good (ICC = 0.83, p< 0.001). There was a stronger correlation between PASTUL and upper limb mRSS in dcSSc compared with lcSSc (0.69 vs 0.51, p< 0.001). In participants with early disease (< 4 years) PASTUL was moderately correlated with HRQoL (r = 0.53, p< 0.001), correlations were weaker in the whole group. Mean time to do the PASTUL self-assessment was 5.0 min (SD 3.7)., Conclusion: PASTUL is a feasible outcome tool that adds to assessments as SSPRO. Skin thickening is correlated with HRQoL, particularly in early disease., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: Ocrelizumab (OCR) effectively modifies the disease course in multiple sclerosis (MS) patients but may cause a preinfusion "wearing-off phenomenon" (WoP). This study explored the prevalence, timing, and severity of this phenomenon in MS patients using the OCR, as well as the associated symptoms and treatment satisfaction., Methods: We conducted a prospective multicenter study across 11 MS centers involving MS patients aged 18-70 years who had received at least two OCR doses. The study employed a questionnaire addressing demographic, clinical, and radiological data; symptom progression; and treatment satisfaction., Results: Of the 409 patients included in the study, 406 participated. A significant portion experienced varying degrees of WoP: 39.2% sometimes, 25.9% usually, and 14.3% always, with 55.9% noting symptom onset over four weeks prior to their next dose. Common symptoms included fatigue, walking difficulties, and pain. Subgroup analysis of 334 patients revealed that 78.1% of patients experienced these effects, which correlated with shorter disease durations, a longer delay between the two doses before the last dose, and a greater rate of relapse (P>0.05)., Conclusion: The WoP of the OCR is prevalent and significant among MS patients and is influenced by the dosing interval, disease duration, and relapse rate. These insights underscore the need for personalized treatment schedules and more research into factors affecting MS management., Competing Interests: Declaration of competing interest The authors have no relevant financial or non-financial interests to disclose., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Randall S Porter,1 Kathleen Holt,2 Rajeev S Ramchandran3 1Pediatric Ophthalmology and Ocular Genetics Service, University of Rochester Flaum Eye Institute, Rochester, NY, USA; 2University of Rochester Clinical & Translational Science Institute, Rochester, NY, USA; 3Retina and Vitreous Service, University of Rochester Flaum Eye Institute, Rochester, NY, USACorrespondence: Randall S PorterFlaum Eye Institute, Box 659, 601 Elmwood Ave, Rochester, NY, 14642, USATel +1 585 275-7039Fax +1 585 275-2352Email Randall_Porter@urmc.rochester.eduPurpose: The full utility of general health Patient-Reported Outcomes Measurement Information System® (PROMIS) surveys in the eye care setting has not been previously demonstrated. This report demonstrates the feasibility of implementing PROMIS in an eye care clinic.Patients and Methods: Over 2 months, general health and functioning PROMIS surveys were offered to all patients in an optometric clinic in Rochester, NY. Demographic and clinical variables were recorded along with percent completion and time to completion of the survey.Results: Across 651 patients, 258 chose to attempt PROMIS. Patients with low visual acuity were less likely to attempt the survey (p=0.049), and younger patients were more likely to complete the survey (p=0.025); no other patient characteristics were found to differ between those who did and did not participate in, nor complete, PROMIS. A total of 193 patients completed the survey (74.8%) in a mean time of 6.36 minutes (range = [1.43, 51.92] minutes; standard deviation = 5.62 minutes). Time to completion did not vary significantly across any groups.Conclusion: Our relatively high completion rate among those who attempted PROMIS indicates that PROMIS surveys are feasible to implement in an optometry clinic. While most patients completed the survey in little time, the large range of time to completion may indicate that some patients had difficulty completing the survey. Furthermore, the significant difference in visual acuity between those who participated in the survey and those who did not highlights the need to address the way PROMIS is delivered in order to foster greater inclusion.Keywords: patient-reported outcome, PRO, ophthalmology, optometry, clinic

Abstract Background Kidney failure with replacement therapy and hemodialysis are associated with a decrease in quality of life (QOL). Self-reported QOL symptoms are not always prioritized by the medical team, potentially leading to conflicting priorities with patients. Electronic patient-reported outcome measures (ePROMs) allow physicians to better identify these symptoms. The objective was to describe the prevalence of symptoms self-reported by hemodialysis (HD) patients. Methods A multicenter cross-sectional study was conducted in three HD centers. Patients were included if they were 18 years old or over treated with HD for at least 3 months in a center. Data were collected by the patient via a self-administered ePROMs questionnaire. Data included patient characteristics, post-dialysis fatigue and intensity, recovery time after a session, perceived stress, impaired sleep the day before the dialysis session, current state of health and the change from the past year. A multivariate analysis was conducted to identify relations between symptoms. Results In total, we included 173 patients with a mean age of 66.2 years, a mean ± SD hemodialysis duration of 48.9 ± 58.02 months. The prevalence of fatigue was 72%. 66% had a high level of stress (level B or C). Recovery time was more than 6 h after a HD session for 25% of patients and 78% declared they had a better or unchanged health status than the previous year. Sleep disturbance was associated with cardiovascular comorbidities (OR 5.08 [95% CI, 1.56 to 16.59], p = 0.007). Conclusions Fatigue and stress were the main symptoms reported by HD patients. The patient’s care teams should better consider these symptoms.

Sonal Ghura Mansukhani,1 Elizabeth A MacLean,2 Laura L Manzey,2 Carl J Possidente,2 Joseph C Cappelleri,2 Linda S Deal2 1Patient Centered Outcomes Research, Evidera, Waltham, Massachusetts, USA; 2Medical Outcomes Specialists (EAM, LLM, CJP); Patient Centered Outcome Assessment (LSD); Biostatistics (JCC), Pfizer Inc., New York, NY, USACorrespondence: Linda S Deal Email Linda_Deal@yahoo.comPurpose: The purpose of this research was to conceptualize and develop a tool for identifying persons who are, or are likely to be, non-adherent to medications prescribed by their healthcare provider(s) by identifying concerns that patients have regarding their treatments.Patients and Methods: The target populations were persons diagnosed with atrial fibrillation or osteoarthritis, who were prescribed anticoagulants or over-the-counter or prescription pain medications, respectively. In this two-stage, multi-year, qualitative research study, relevant concepts were explored, confirmed and refined. The focus was on non-adherence due to active (thus potentially modifiable) patient decisions to forego taking medications as prescribed.Results: The most common concerns among participants with atrial fibrillation were medication-related side effects and fear of bleeding. Participants with osteoarthritis were most concerned about short-term stomach problems and long-term kidney and liver side effects. The Concerns Influencing Medication Adherence (CIMA) instrument was developed based on these concerns and those identified in the literature. It is comprised of 16 items: a core set of 11 items potentially applicable to multiple disease states, 3 items specific to atrial fibrillation, and 2 items unique to osteoarthritis. The instrument is intended to be completed electronically, and publicly available for use in direct patient care in the United States or in population health management.Conclusion: To our knowledge, this is the first instrument focused on medication adherence that includes documented details of patient input as recommended by the United States Food and Drug Administration guidance. Patient input is considered a key component of content validity. In this research, for example, the concerns that patients have regarding their treatments can be expected to have affected past medication adherence and can potentially impact future adherence. Although applicability outside atrial fibrillation or osteoarthritis was not assessed, the general items may be useful in assessing adherence in other chronic diseases.Keywords: medication adherence, content validity, patient-reported outcome, atrial fibrillation, osteoarthritis

Abstract Background Intense and aggressive treatment regimens for most children’s cancer have achieved vast improvements in survival but are also responsible for both a high number and burden of symptoms. The use of Patient Reported Outcome Measures (PROMs) demonstrates a range of benefits for improved symptom management in adults with cancer. There are, however, multiple barriers to integrating PROMs into routine care in children and adolescents with cancer. This study aims to evaluate: (1) the effectiveness of electronic PROMs to generate stratified alerts, symptom management recommendations and graphical summaries (the RESPONSE system) to improve health outcomes and (2) the implementation of the RESPONSE system by assessing feasibility, acceptability, satisfaction, and sustainability. Methods A pragmatic hybrid II effectiveness-implementation controlled trial, using mixed methods, will be undertaken, advancing both knowledge of the effectiveness of the intervention and implementation factors. One-hundred and sixty children with cancer receiving active treatment will be recruited 1:1 to a non-randomised study involving two groups with an equal number of participants in each group. The intervention group (n = 80) will be prospectively recruited to receive the RESPONSE system intervention over eight weeks, versus the historical matched control group (n = 80) who will complete the ePROMs without access to the RESPONSE system. The primary outcome of the effectiveness trial is change between groups in total symptom burden. Secondary outcomes include child health-related quality-of-life and implementation outcomes. Trial data will be analysed using linear mixed-effects models. Formative implementation evaluation is informed by CFIR and ERIC frameworks and implementation outcomes will be mapped to the RE-AIM framework and include interviews, field notes, as well as administrative data to evaluate feasibility, acceptability, satisfaction and sustainability. Trial registration number ACTRN12621001084875 . Retrospectively Registered 16 August 2021.

BackgroundNipple-sparing mastectomy (NSM) followed by immediate breast reconstruction (IBR) is the optimal surgical treatment for breast cancer. However, investigations are ongoing to improve the surgical technique to achieve better results. This study aimed to evaluate the outcomes of modified NSM (m-NSM), which preserves the anterior lamellar fat layer, in patients who underwent IBR.MethodsAll patients who underwent modified NSM (m-NSM) or conventional NSM (c-NSM) followed by IBR using autologous tissue or implants were retrospectively reviewed between January 2014 and January 2021. Two mastectomy types were compared in terms of postoperative complications and aesthetic outcomes using panel assessment scores by physicians and reported outcomes using Breast-Q. In addition, postoperative evaluations of the thickness of mastectomy flap was performed using CT scan images.ResultsA total of 516 patients (580 breasts) with NSM (143 breasts with c-NSM and 437 breasts with m-NSM) followed by IBR were reviewed. The mean ± SD flap thickness was 8.48 ± 1.81 mm in patients who underwent m-NSM, while it was 6.32 ± 1.15 mm in the c-NSM cohort (p = 0.02). The overall major complications rate was lower in the m-NSM group (3.0% vs. 9.0%, p

Background: The Patient-Reported Outcomes Measurement Information System 29-item Profile (PROMIS-29) has been widely used to measure health outcomes from the patient's perspective. It has not been validated in adults with aortic disease. The aim of this study was to explore the reliability and validity of the Chinese PROMIS-29 among patients undergoing surgery for aortic dissection (AD).Methods: A cross-sectional design was applied. Eligible patients completed a questionnaire that contained the PROMIS-29 and legacy measures, including the Short Form-12 Health Survey (SF-12), 8-item Somatic Symptom Scale (SSS-8), Generalized Anxiety Disorder-2 (GAD-2), and Patient Health Questionnaire-2 (PHQ-2). The structural validity of the PROMIS-29 was evaluated using confirmatory factor analysis (CFA). Reliability was evaluated with Cronbach's α. Construct validity was assessed by calculating Spearman's rank correlations and comparing known-group differences.Results: In total, a sample of 327 AD patients was included in the final analysis. Most of them were male (89%) with a mean age of 52.7 (± 10.3). CFA revealed good model fit of the seven-factor structure within PROMIS-29, as well as most domains in single-factor analysis. Reliability was confirmed with Cronbach's α > 0.90. Correlations between comparable domains of the PROMIS-29 and those of legacy questionnaires and most know-group comparisons were observed as hypothesized.Conclusions: This study found evidence for acceptable structural validity, construct validity and internal consistency of the PROMIS-29 in a sample of AD patients. It can be applied to AD survivors by researchers or clinicians, measuring outcomes after surgery and identifying those with worse health status. [ABSTRACT FROM AUTHOR]

Background: Associations between patient‐reported outcomes and dose to organs at risk (OARs) may promote management and guide future investigations. Methods: We retrospectively evaluated PROs and OAR dose in head and neck (H&N) cancer. Results: In 169 patients, we identified weak associations between: "Difficulty swallowing/chewing" and increased mean RT dose to the oral cavity, larynx, pharyngeal constrictor muscles (PCM) and contralateral parotid; "choking/coughing" and larynx mean dose; "problems with mucus in mouth and throat" and oral cavity, contralateral parotid mean dose and parotid V30, contralateral submandibular gland and PCM mean dose; "difficulty with voice/speech" and oral cavity, contralateral parotid, contralateral submandibular gland and larynx mean dose; and "dry mouth" and ipsilateral submandibular gland, oral cavity and PCM mean dose. Conclusion: We identified weak associations between PRO and dose to OARs—these data can guide on treatment management, patient counseling, and serve as a baseline for future investigations. [ABSTRACT FROM AUTHOR]

Abstract Background Rehabilitation following anterior cruciate ligament (ACL) reconstructions is based mainly on comprehensive progressive exercise programmes using a multi-dimensional approach. Elastic knee sleeves may be useful adjuncts to rehabilitation. The aim of this study was to determine the immediate and 6-week effects of wearing a knee sleeve on person-reported outcomes and function in participants who had undergone an ACL reconstruction and who had residual self-reported functional limitations. Methods Individuals with ACL reconstruction in the previous 6 months to 5 years were recruited. Immediate effects of a commercially-available elastic knee sleeve on single-leg horizontal hop distance were explored using a cross-over design. Following this first session, participants were randomised into a Control Group and a Sleeve Group who wore the sleeve for 6 weeks, at least 1 h daily. Outcome measures for the randomised clinical trial (RCT) were the International Knee Documentation Classification Subjective Knee Form (IKDC-SKF) score, the single-leg horizontal hop distance, and isokinetic quadriceps and hamstring peak torque. Linear mixed models were used to determine random effects. Where both limbs were measured at multiple time points, a random measurement occasion effect nested within participant was used. Results Thirty-four individuals (16 women) with ACL reconstruction completed the cross-over trial. Hop distance for the injured side during the sleeve condition increased by 3.6 % (95 % CI 0.4–6.8 %, p = 0.025). There was no evidence of differential changes between groups for the IKDC-SKF (Sleeve Group n = 15; Control Group n = 16; p = 0.327), or relative improvement in the injured side compared to the uninjured side for the physical performance measures (Sleeve Group n = 12, Control Group n = 12; three-way interaction p = 0.533 [hop distance], 0.381 [quadriceps isokinetic peak torque], and 0.592 [hamstring isokinetic peak torque]). Conclusions Single-leg hop distance of the ACL reconstructed side improved when wearing a knee sleeve. Wearing the knee sleeve over 6 weeks did not lead to enhanced improvements in self-reported knee function, hop distance and thigh muscle strength compared to the control group. Trial registration The trial was prospectively registered with the Australia New Zealand Clinical Trials Registry No: ACTRN12618001083280 , 28 June 2018.

Abstract Background Management of talar fractures remains to be one of the most challenging aspects in trauma surgery. Unfortunately, the evidence regarding the correct treatment of these fractures is mainly based on retrospective case series, while studies assessing the patient-reported outcome are rare. Therefore, the aim of this trial was to analyze the patient reported outcome in context of trauma mechanism and concomitant injuries following operative treatment of talar fractures. Methods A retrospective outcome study of patients with operatively treated talar fractures between 2003 and 2015 was conducted. The fractures were classified according to AO-/Hawkins classification system and to the Marti-Weber classification. Data was collected via patient registry, radiographs and a validated patient-reported outcome measure (PROM) for foot and ankle pathologies (Foot and Ankle Outcome Score = FOAS). An analysis regarding the functional outcome, concomitant injury and timing of surgery using the nonparametric Mann-Whitney U test and Spearman`s rank correlation was performed. Results In total the functional outcome of 32 patients suffering from fractures to the talus were analyzed. The median age of the study cohort was 35±12.2 years, including 9 female (28 %) and 23 male (72 %) patients. The median FAOS score was 72±22.7 (range 13–94). Patients with an isolated talar fracture had an FAOS of 87±20 and with concomitant injury a score of 60±23.4 (p = 0.016). Patients with a closed talar fracture without emergency operation due to dislocation or polytrauma, showed no correlation between timing of surgery and FAOS (r= -0.17, p = 0.43). 10 % of the patients developed an avascular necrosis and 25 % showed signs of a posttraumatic arthritis. The follow-up time was 41 months (range: 16–145). Conclusions Talar fractures were typically caused by high-energy trauma often associated with additional injuries of the lower extremity. The majority of the patients showed a fair to poor functional long-term outcome. Concomitant injuries of the lower extremity led to a lower FAOS. In closed talar fractures without the necessity of an emergency surgical intervention, time to surgery did not influence the patient reported outcome. Relating to the presented data, delayed surgery after soft tissue consolidation was not associated with a higher risk of developing an avascular necrosis.

Hyun-Il Gil,1,* Sungmin Zo,2,* Paul W Jones,3,4 Bo-Guen Kim,2 Noeul Kang,2 Yeonseok Choi,5 Hyun Kyu Cho,6 Danbee Kang,7 Juhee Cho,7 Hye Yun Park,2 Sun Hye Shin2 1Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; 2Division of Pulmonary and Critical Care Medicine, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; 3Institute For Infection and Immunity, St George’s University of London, London, UK; 4Value Evidence and Outcomes, Global Medical R&D, GlaxoSmithKline, Uxbridge, UK; 5Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Republic of Korea; 6Division of Pulmonary and Critical Care Medicine, Department of Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Republic of Korea; 7Samsung Advanced Institute for Health Sciences & Technology (SAIHST), Sungkyunkwan University, Seoul, Republic of Korea*These authors contributed equally to this workCorrespondence: Sun Hye Shin; Hye Yun ParkDivision of Pulmonary and Critical Care Medicine, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of KoreaTel +82-2-3410-3429Fax +82-2-3410-3849Email freshsunhye@gmail.com; hyeyunpark@skku.eduPurpose: The chronic obstructive pulmonary disease (COPD) assessment test (CAT) is widely used to assess the impact of COPD symptoms on health status. Whilst the CAT consists of eight different items, details on the distribution of each item are limited. This study aimed to investigate the distribution and clinical implication of each CAT item, stratified by CAT severity group, in stable COPD patients.Patients and Methods: This was a cross-sectional study at a single referral hospital in South Korea. Spirometry confirmed COPD patients with CAT measured at the first clinical visit were retrospectively identified. Patients were categorized into three groups: low (0 ≤ CAT < 10), medium (10 ≤ CAT < 20), and high (20 ≤ CAT ≤ 40) impact group. For the purpose of this analysis, the first four items (cough, sputum, chest tightness, and dyspnea) and the remaining four items (activities, confidence, sleep and energy) were also grouped as “pulmonary” and “extra-pulmonary”, respectively.Results: A total of 815 patients were included, and mean (SD) forced expiratory volume in 1 s (FEV1) was 62.8 (17.4) % pred. Among them, 300 patients (36.8%) were in the high impact group and had a greater exacerbation history and lower lung function. The proportion of “extra-pulmonary” items score was greater in patients with higher total CAT scores, with the activity and confidence items showing higher scores.Conclusion: In our study, in addition to dyspnea, activity limitation is a particular problem in individual patients with higher CAT total scores, for which physicians need to pay more attention. Our study suggests that whilst CAT total score captures the overall impact of COPD, each item of the CAT contains potentially useful information in understanding the patient’s symptom burden.Keywords: COPD, COPD assessment test, patient reported outcome, symptom

Post-stroke morbidity is common, but little is known about the burden on patients' lives from their own perspective. Understanding morbidity from the point of view of the patient may support targeted intervention in post-stroke recovery. This study used a stroke specific Patient Reported Outcome Measure (PROM) containing Mental health (MH) and Physical Health (PH) domains and 5 stroke specific questions. We aimed to consider trends over a 6-month period and further assess the association between the MH and PH measures and common clinical measures. A multicenter prospective cohort study was conducted at 19 hospital sites across England and Wales. Patients were enrolled from August 2018 to September 2019. Clinical measures and PROMs were assessed at three timepoints: acutely following the index stroke, at 3 and 6-months post-stroke. Clinical measures and PROMs were assessed in each of these points. Physical health PROM domains show significant gradual improvement across the study period (χ2 42.6312, p<0.0001), whereas cognitive function domains (χ2 3.7849, p<0.875) did not echo this trend. All clinical measures (GAD-7, PHQ9, MoCA, MRS) were associated with poorer PROM MH outcomes, (aMD -4.4, CI -0.59, -0.29, p ≤0.001, aMD -0.45, CI -0.59, -0.32, p =<0.001, aMD 0.75, CI 0.56, 0.95, aMD -1.91, CI -2.41, -1.47, p ≤0.001). Clinical measures of disability, as per the MRS, are associated with poor PROM PH scores (aMD -0.57, 95% CI -0.94, -0.20, p =0.003). This research indicates there is unmet cognitive burden in stroke survivors. PROMs may be able to measure unmet more discretely than common clinical tools that are used post-stroke. Further research and guidance on how to integrate PROMs into current clinical frameworks is essential. [ABSTRACT FROM AUTHOR]

BackgroundAngina has important implications for patients' quality of life and healthcare utilization. Angina management after acute myocardial infarction (MI) treated with percutaneous coronary intervention (PCI) is unknown.Methods and resultsTRANSLATE-ACS (Treatment With Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome) was a longitudinal study of MI patients treated with percutaneous coronary intervention at 233 US hospitals from 2010 to 2012. Among patients with self-reported angina at 6 weeks post-MI, we described patterns of angina and antianginal medication use through 1 year postdischarge. Of 10 870 percutaneous coronary intervention-treated MI patients, 3190 (29.3%) reported angina symptoms at 6 weeks post-MI; of these, 658 (20.6%) had daily/weekly angina while 2532 (79.4%) had monthly angina. Among patients with 6-week angina, 2936 (92.0%) received β-blockers during the 1 year post-MI, yet only 743 (23.3%) were treated with other antianginal medications. At 1 year, 1056 patients (33.1%) with 6-week angina reported persistent angina symptoms. Of these, only 31.2% had been prescribed non-β-blocker antianginal medications at any time in the past year. Among patients undergoing revascularization during follow-up, only 25.9% were on ≥1 non-β-blocker anti-anginal medication at the time of the procedure.ConclusionsAngina is present in one third of percutaneous coronary intervention-treated MI patients as early as 6 weeks after discharge, and many of these patients have persistent angina at 1 year. Non-β-blocker antianginal medications are infrequently used in these patients, even among those with persistent angina and those undergoing revascularization.

The objective of this study was to describe muscle cramps in an US sample of amyotrophic lateral sclerosis (ALS) patients. Utilizing an anonymous web based questionnaire we queried ALS patients regarding the severity, frequency, time-course, treatment of muscle cramps and their relationship to pain. The survey had 282 respondents with 92% reporting that they had cramps. For 20% of the sample, cramps were stated to be the presenting ALS symptom. Cramp severity was rated at a mean of 5.2/10 and the mean cramp frequency was 5.3 cramps per day. Cramp intensity and frequency did not correlate with duration or severity of ALS. Pain as measured with the Patient Reported Outcome Measurement Information System (PROMIS) pain scales was not statistically different from the US general population. Cramp severity and frequency significantly and positively correlated with the PROMIS pain scales. Patients with more severe cramps were more likely to use prescription medications for their cramps compared to patients with milder symptoms. Treatments directed at cramps were tried by 57%. In conclusion, cramps are a common symptom in ALS and it does not correlate with disease duration or severity. The severity of cramps is on average moderate and many patients try treatments.

The Cleft Q, a patient-reported outcome measure, has been adopted by the International Consortium for Health Outcome measurement as a valid tool for the measurement of outcomes following intervention on a patient with a cleft. It is scarcely used in sub-Saharan Africa. We report our first experience with the Cleft Q in measuring the outcomes following palatoplasty in an African adult female with a Veau type II defect. The Cleft Q was able to demonstrate improved scores across all domains measured. There is however a need for further validation of the Cleft Q in our setting.

Background and purpose: Little is known about the outcome after receiving total hip arthroplasty (THA), specifically in young patients. We identified different recovery trajectories in young patients using data from the Dutch Arthroplasty Register (LROI). We also explored whether risk factors commonly associated with functional outcome were associated with recovery trajectory. Patients and methods: We used HOOS-PS score data up to 1 year postoperatively from the LROI from all patients younger than 55 years who received a primary THA between 2014 and 2019. To investigate whether different recovery trajectories could be distinguished, we performed latent class growth analysis (LCGA). Subsequently, we used multinomial logistic regression analyses to explore factors associated with class membership. Results: 3,207 patients were included. LCGA identified 3 groups of patients: optimal responders (75%), good responders (21%), and poor responders (4.7%). Female sex (RR 1.1; 95% CI 1.1–1.1), ASA II (RR 1.1; CI 1.0–1.1), ASA III–IV (RR 1.1; CI 1.0–1.2), smoking (RR 1.1; CI 1.0–1.1), cemented fixation (RR 1.2; CI 1.1–1.2), and a 22–28 mm head diameter (RR 1.1; CI 1.0–1.2) were associated with “good responder” class membership. ASA II (RR 1.1; 1.0–1.2), ASA III–IV (RR 1.2; 1.1–1.3), smoking (RR 1.2; CI 1.1–1.2), and hybrid fixation (RR 1.2; CI 1.0–1.2) were associated with “poor responder” class membership. Interpretation: 3 recovery trajectories could be identified. Female sex, higher ASA classifications, smoking, cemented or hybrid fixation, and small head diameter were associated with a suboptimal result after primary THA in young patients. These findings can aid in the process to determine which patients are at risk of a suboptimal outcome.

Abstract Background The main genetic causes of homocystinuria are cystathionine beta-synthase (CBS) deficiency and the remethylation defects. Many patients present in childhood but milder forms may present later in life. Some countries have newborn screening programs for the homocystinurias but these do not detect all patients. Results HCU Network Australia is one of the very few support groups for patients with homocystinurias. Here we report the results of its survey of 143 patients and caregivers from 22 countries, evaluating current diagnostic pathways and management for the homocystinurias. Most (110) of the responses related to patients with CBS deficiency. The diagnosis was made by newborn screening in 20% of patients and in 50% of the others within 1 year of the initial symptom but in 12.5% it took over 15 years. The delay was attributed mainly to ignorance of the disease. Physicians need to learn to measure homocysteine concentrations in children with neurodevelopmental problems, and in patients with heterogeneous symptoms such as thromboembolism, dislocation of the optic lens, haemolytic uraemic syndrome, and psychiatric disease. Even when the diagnosis is made, the way it is communicated is sometimes poor. Early-onset CBS deficiency usually requires a low-protein diet with amino acid supplements. More than a third of the participants reported problems with the availability or cost of treatment. Only half of the patients always took their amino acid mixture. In contrast, good adherence to the protein restriction was reported in 98% but 80% said it was hard, time-consuming and caused unhappiness. Conclusions There is often a long delay in diagnosing the homocystinurias unless this is achieved by newborn screening; this survey also highlights problems with the availability and cost of treatment and the palatability of protein substitutes.

Background: Health-related quality of life (HRQoL) is important in determining surgical success, particularly from the patients' perspective.Aims: To identify predictors for HRQoL outcome after cardiac surgery in order to identify potentially modifiable factors where interventions to improve patient outcomes could be targeted.Methods: Electronic databases (including MEDLINE, CINAHL, Embase) were searched between January 2001 and December 2020 for studies determining predictors of HRQoL (using a recognised and validated tool) in adult patients undergoing cardiac surgery. Data extraction and quality assessments were undertaken and data was summarised using descriptive statistics and narrative synthesis, as appropriate.Results: Overall, 3924 papers were screened with 41 papers included in the review. Considerable methodological heterogeneity between studies was observed. Most were single-centre (75.6%) prospective observational studies (73.2%) conducted in patients undergoing coronary artery bypass graft (CABG) (n = 51.2%) using a version of the SF-36 (n = 63.4%). Overall, 103 independent predictors (62 pre-operative, five intra-operative and 36 post-operative) were identified, where 34 (33.0%) were reported in more than one study. Potential pre-operative modifiable predictors include alcohol use, BMI/weight, depression, pre-operative quality of life and smoking while in the post-operative period pain and strategies to reduce post-operative complications and intensive care and hospital length of stay are potential therapeutic targets.Conclusion: Despite a lack of consistency across studies, several potentially modifiable predictors were identified that could be targeted in interventions to improve patient or treatment outcomes. This may contribute to delivering more person-centred care involving shared decision-making to improve patient HRQoL after cardiac surgery. [ABSTRACT FROM AUTHOR]

• We have identified the most frequently used PROMs in pediatric general surgery and their individual characteristics. • A conceptual understanding of FDH and QoL⁄HRQoL, prioritization of child self-reporting, and the inclusion of patients and family partners in PROMs development and selection are strongly recommended. • We discourage creating more in-house questionnaires for specific studies, and reinforce instead the further validationof quality existing PROMs, such as the EA-QOL and HAQL. With improved long-term survival rates, measuring the quality of surgical care has gradually shifted from clinical morbidity and mortality to patient-reported outcome measures (PROMs). Since the use of PROMs in pediatric surgery is still limited, we undertook a study to identify current PROMs, assess their characteristics, and identify gaps and areas for improvement. A search was conducted in eight databases from their inception until May 2021 to identify PROMs that have been used in pediatric surgical patients. PRISMA standards were followed, and screening was completed by two independent reviewers. The quality of the included studies was appraised using the AXIS and the Mixed Methods Appraisal Tool. Of 8282 studies screened, 101 articles met the inclusion criteria. Most of the studies (99%) were cross-sectional. We identified 85 different PROMs among the studies, 53 being disease-specific and the rest generic. The PedsQL™ was the most frequently used tool (42 studies). Almost half of the instruments (41 studies) were not validated, and 28% were developed ad hoc for each specific study. Significantly, all PROMs encountered were standardized (consisting of pre-determined domains), with no individualized tools currently in use. The overall quality of the included studies was good. PROMs are increasingly used in pediatric surgery. Disease-specific PROMs predominate the field, yet validated and especially individualized PROMs are notably absent. Future efforts are needed to develop robust tools that reflect individual patient and family needs, preferences, and values, with the aim of furthering family-centered pediatric surgical care. [ABSTRACT FROM AUTHOR]

Background and Purpose: The use of patient reported outcomes measures (PROMs) may offer utility that are important for stroke survivors. This study assessed the PROMIS-10, which contains Mental health (MH) and Physical Health (PH) domains, with an additional five stroke specific questions. The aim of this study was to evaluate the association between the MH and PH measures following a stroke and pre-existing health conditions.Methods: A multicentre prospective cohort study at 19 hospital sites across England and Wales during 2019 was conducted. The association between each PROMIS-10 domain and demographic and health conditions were calculated using a multilevel multivariable linear and present the adjusted mean difference (aMD).Results: The study enrolled 549 stroke survivors within 14 days of the index event, 232 were women (42.3%) and with a mean age of 72.7 years (SD = 12.9, range 25 to 97). The MH domain was scored as poor in 3.9% of participants, and very good or excellent in almost a half (48.4%). In contrast the PH domain was scored as poor in 39.9%, compared to very good or excellent in 8.5%. The MH domain was associated with pre-existing diabetes (aMD = - 2.01; 95%CI -3.91, - 0.12; p = 0.04), previous stroke (aMD = - 3.62; 95%CI -5.86, - 1.39; p = 0.001), age (aMD = 0.07; 95%CI: 0.01, 0.14; p = 0.037), and female sex (aMD = 1.91; 95%CI 0.28, 3.54; p = 0.022). The PH domain was found to be associated with sex (female) (aMD = 2.09; 95%CI 0.54, 3.65; p = 0.008) and previous stroke (aMD = - 3.05; 95%CI -5.17, - 0.93; p = 0.005).Conclusions: Almost half of stroke survivors reported poor PH using a PROM with less reporting poor MH. age, and sex were associated with both MH and PH domains, and additionally pre-exising diabetes and stroke were associated with poorer MH. Clinical management offers an opportunity to investigate and intervene to prevent long term poorer health in stroke survivors. [ABSTRACT FROM AUTHOR]

To perform a cross-cultural adaptation and validation of the Johns Hopkins Fall Risk Assessment Tool to develop its Spanish version (JHFRAT-Sp). Two hundred eleven participants aged 60 years or older participated in this observational study. After translation and transcultural adaptation of the JHFRAT-Sp, the internal consistency, criterion validity and construct validity were calculated using the Falls Efficacy Scale International, Foot Health Status Questionnaire (FHSQ), Health Questionnaire EuroQol (5Dimensions and VAS), Short Form-12v2 and Health Assessment Questionnaire. The internal consistency was 0.986. The test-retest analysis ranged from 0.971 to 0.983. The error measures presented values in MDC90 and SEM of 0.602 and 1.404%, respectively. The chi-Square value was 120.662 (p < 0.001). The extraction method by principal components showed a solution of four factors. Regarding the criterion validity, the correlation value ranged from r = 0.200 (FHSQ-Vigour) to r = 0.891 (EuroQol-VAS). The JHFRAT was translated and adapted culturally from the original version to Spanish. The psychometric analysis carried out in the JHFRAT-Sp showed excellent reliability, as well as satisfactory results both in the measurement error analysis and in the construct and criterion validities. Spanish researchers and clinicians may use this tool to analyse the risk of falling. A transcultural translation and adaptation of the JHFRAT questionnaire into Spanish (JHFRAT-Sp) has been carried out. The JHFRAT-Sp questionnaire is shown as a tool with very satisfactory psychometric characteristics, which would allow its use by both researchers and clinicians for the evaluation and monitoring of patients at risk of falls. The results that can be extracted from the use of JHFRAT-Sp, can be compared with the same type of patients who have used the same questionnaire but in other clinical or research environments that have the validated version of JHFRAT in their native language, such as English, Chinese or Portuguese (Brazilian). [ABSTRACT FROM AUTHOR]

Background: Several bone-seeking radionuclides have been developed for palliation of metastatic bone pain since 1956, however, so far radium-223 dichloride is the first and only Food and Drug Administration (FDA) approved targeted alpha therapy for metastatic castration-resistant prostate cancer (mCRPC) based on ALSYMPCA phase 3 study. While radium-223 does improve pain and overall survival outcomes, the improvement can come at the expense of side effects such as bone marrow toxicity. The development of new and better treatment with long-standing pain relief is clearly an unmet medical need.Methods: The study is a non-randomized phase II study. The study population consists of 25 patients with CRPC who had progressed on any lines of prior therapies and whose serum testosterone level is less than 50 ng/dl and have metastatic lesions to at least two bone sites, with at least one site that has clinically meaningful pain at baseline (≥ 4 on an 11-point intensity scale). Eligible patients will be given two cycles of Sn-117 m-DTPA every 8 weeks or 56 days. Treatment will be administered by slow IV injection over 5-10 min. Retreatment after two cycles is allowed if patients meet the following retreatment criteria. The primary objective is to evaluate the efficacy of Sn-117 m-DTPA on sustained pain response in patients with CRPC metastatic to at least two bone sites and at least one with clinically meaningful pain at baseline (≥ 4 on an 11-point pain intensity scale). Sustained pain response is defined as: 1) achieving pain index ≤ 3 within a 12-week period and 2) maintaining pain index ≤ 3 over a 16-week period. The secondary objectives are: safety and tolerability, measurement of Sn-117 m-DTPA activity by gamma-camera dosimetry scans, therapeutic efficacy, time to the first symptomatic skeletal event, duration of pain response, changes in PSA and ALP levels, patient-reported outcomes and progression free survival and overall survival.Discussion: Sn-117 m-DTPA is a unique bone-targeting theranostic radiopharmaceutical agent that selectively binds most heavily to bone metastases sites. This study will be the first prospective phase II trial to assess the pain efficacy and anti-tumor activity of Sn-117 m-DTPA in mCRPC with at least one clinically meaningful pain at baseline.Trial Registration: ClincialTrials.gov Identifier: NCT04616547. [ABSTRACT FROM AUTHOR]

Introduction: The Danish Knee Ligament Reconstruction Registry (DKRR) has monitored the outcomes of surgeries for multi-ligament knee injuries (MLKI) since 2005. This study aimed to compare the subjective clinical outcomes of patients who had undergone surgery after MLKI with those of patients who had received isolated anterior cruciate ligament (ACL) reconstruction. Materials and methods: This study used patient-reported outcome scores at 1-year follow-up as the primary outcome and contains the outcome data of knee ligament surgeries retrieved from the DKRR. Clinical subjective outcomes and knee function were evaluated with Knee Injury and Osteoarthritis Outcome Scores (KOOS) and Tegner Activity Scale (Tegner) scores. Demographic differences were examined using the Student's t-test and the chi-square test. Multiple linear regression was used to analyse the data and adjust for potentially confounding factors. P-values < 0.05 were considered to be statistically significant. Results: A total of 31,686 knee ligament surgeries were registered in the DKRR between 2005 and 2017, resulting in 1,160 multi-ligament patients and 28,843 isolated ACL patients. The mean age of the MLKI group was significantly higher than that of the isolated ACL group (33.2 years [95% CI 32.5–33.9] vs. 28.3 years [95% CI 28.1–28.4]). The adjusted KOOS Sport and Quality of Life (QoL) sub-scores and Tegner scores of the MLKI group significantly improved from the baseline to the 1-year follow-up (16.7 points [95%CI 12.8;20.6], 12.6 points [95%CI 9.6;15.6] and 1.76 points [95%CI 1.43;2.08], respectively). The KOOS Sport and QoL sub-scores of the isolated ACL group were significant and increased more than those of the MLKI group. No differences in the Tegner scores were observed. Conclusions: Surgical reconstruction after multi-ligament knee injury resulted in significant subjective outcome improvements at 1- year follow-up. The KOOS Sport and QoL sub-scores of the isolated ACL group significantly increased compared to those of the MLKI group. [ABSTRACT FROM AUTHOR]

Background: eHealth technologies for self-management can improve quality of life, but little is known about whether the benefits gained outweigh their costs. The electronic patient-reported outcome (ePRO) mobile app and portal system supports patients with multiple chronic conditions to collaborate with primary health care providers to set and monitor health-related goals. Objective: This study aims to estimate the cost of ePRO and the cost utility of the ePRO intervention compared with usual care provided to patients with multiple chronic conditions and complex needs living in the community, from the perspective of the publicly funded health care payer in Ontario, Canada. Methods: We developed a decision tree model to estimate the incremental cost per quality-adjusted life year (QALY) gained for the ePRO tool versus usual care over a time horizon of 15 months. Resource utilization and effectiveness of the ePRO tool were drawn from a randomized clinical trial with 6 family health teams involving 45 participants. Unit costs associated with health care utilization (adjusted to 2020 Canadian dollars) were drawn from literature and publicly available sources. A series of sensitivity analyses were conducted to assess the robustness of the findings. Results: The total cost of the ePRO tool was CAD $79,467 (~US $ 63,581; CAD $1733 [~US $1386] per person). Compared with standard care, the ePRO intervention was associated with higher costs (CAD $1710 [~US $1368]) and fewer QALYs (-0.03). The findings were consistent with the clinical evidence, suggesting no statistical difference in health-related quality of life between ePRO and usual care groups. However, the tool would be considered a cost-effective option if it could improve by at least 0.03 QALYs. The probability that the ePRO is cost-effective was 17.3% at a willingness-to-pay (WTP) threshold of CAD $50,000 (~US $40,000)/QALY. Conclusions: The ePRO tool is not a cost-effective technology at the commonly used WTP value of CAD $50,000 (~US $40,000)/QALY, but long-term and the societal impacts of ePRO were not included in this analysis. Further research is needed to better understand its impact on long-term outcomes and in real-world settings. The present findings add to the growing evidence about eHealth interventions' capacity to respond to complex aging populations within finite-resourced health systems. [ABSTRACT FROM AUTHOR]

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People's sexual experiences have a strong association with contraceptive satisfaction and continuation, but no measures exist to specifically assess contraceptive-related sexual acceptability. This study developed and examined the psychometric properties of reliability, separation, and item fit of a new Contraceptive Sexual Acceptability (CSA) instrument. Enrolled participants initiating a new contraceptive method from the HER Salt Lake longitudinal cohort study contributed baseline survey responses for scale development. The study included the Female Sexual Function Index, the New Sexual Satisfaction Scale, measures of physical and mood-related side effects, and self-reported perceptions of contraception's sexual impacts. Items from these measures' served as the basis for analyses. We analyzed responses using descriptive techniques and modeled using exploratory factor (EFA) and bifactor analyses (BFA). The Masters' Partial Credit Rasch method modeled reliability, separation, and item fit statistics. Here we evaluate (i) the reproducibility of relative measure location on the modeled linear latent variable, (ii) the number of statistically unique performance levels that can be distinguished by the measure, and (iii) the discrepancy between item responses and expectations of the model. Psychometric findings and theoretical models informed item reduction and final scale development. We developed a 10-item Contraceptive Sexual Acceptability scale that exceeded the thresholds and sufficiently covered domains for use in contraceptive research and clinical settings. Starting with data on 39-items from 4,387 individuals, we identified 10-items that best measured the CSA latent construct. The Rasch model included a total of 5 calibrations. We reduced items based on bifactor analysis and surpassed unidimensionality thresholds (OH = 0.84, ECV = 0.74) set a priori. The final items included questions with scaled responses about pleasure and orgasm (orgasm quality, orgasm frequency, giving partner pleasure), physical (arousal and function) and psychological (emotional connection, surrender) components, general questions of satisfaction and frequency, and a measure of perceived impact of contraception on sexual experiences in the previous 4 weeks. The 10-item CSA instrument covers physical and psychological aspects of contraceptive sexual acceptability and can be used in clinical settings. The unidimensional CSA instrument offers a brief, yet comprehensive assessment of sexual acceptability. Given the limited diversity of the sample, implementation of this scale in contraceptive research and clinical interactions should be evaluated and validated in more diverse settings. Attuning to sexual acceptability could ultimately help contraceptive clients find methods that better meet their needs and preferences. Sanders JN, Kean J, Zhang C, et al. Measuring the Sexual Acceptability of Contraception: Psychometric Examination and Development of a Valid and Reliable Prospective Instrument. J Sex Med 2022;19:507–520. [ABSTRACT FROM AUTHOR]

Aim: To analyze the responsiveness and interpretability of the Living with Chronic Illness Scale in patients with Parkinson's disease (LW-CI-PD).Methods: Longitudinal, international study, with a convenience sample of 153 PD Spanish and Latin-American patients assessed at baseline and one year later. The LW-CI-PD and other clinical measures were applied. For responsiveness, Wilcoxon-Mann-Whitney test of differences, correlation of change between rating scales, standard error of difference, relative change, Cohen's effect size and standardized response mean of LW-CI-PD were computed. The minimally clinical important difference was calculated using anchor- (applying the Patient Global Impression of Severity) and distribution-based methods. A triangulation of interpretability indexes was performed to determine the range of the minimally clinical important difference values.Results: The LW-CI-PD scored 65.7 (11.7, range: 33-101) at baseline, and 68.6 (10.3, range: 33-102) one year later (p < 0.001). Change in LW-CI-PD correlated -0.26 with change in psychosocial status, 0.18 with change in motor function and -0.15 with change in social support. Responsiveness statistics were: relative change = 4.5%; effect size = 0.25; standardized response mean = 0.46. Using PGI-S as anchor, 29 patients worsened, and the value of minimally clinical important difference for worsening in LW-CI-PD total score was 4.7. Minimally clinical important difference values using distribution-based methods were between 4.5 (1 standard error of measurement) and 10.4 (10% of total score), with a mean of 6.9.Conclusions: Our study suggest the LW-CI-PD is responsive to changes over time. The use of different methods for calculating the minimally clinical important difference allows to determine a range of the real change for the LW-CI-PD. [ABSTRACT FROM AUTHOR]

Background: Over the years approach to COPD has changed. The focus of evaluation is shifting from physiological outcome parameters to patient centered outcomes. COPD-RF is one such patient related outcome that is of considerable importance to the patients as fatigue is the second common distressing symptom in COPD & is a major concern for the patients. COPD-RF is not only a reflection of airflow limitation severity but also a result of psychological, behavioral and physical factors. Therefore, identification of markers which determine COPD RF is essential to improve patient management. This study aims to identify the predictors of COPD Related fatigue (COPD-RF) and its correlation with other outcome tools like FEV1,6 minute walk distance (6MWD), MMRC grade, BODE index & inflammatory markers. Methodology: 50 stable COPD patients were taken in the study. MMRC grade, FEV1, 6MWD, BODE index, CRP level and sputum neutrophil % obtained. COPD-RF was assessed using 13 item (FACITfatigue) questionnaire. The correlation analysis was done by spearman rank correlation and ANOVA. Predictors of COPD-RF were identified by multiple linear regression. Result: Mean age of the population was 56.53 ± 9.29. All GOLD category of severity was equally represented in the study group. The fatigue score showed significant correlation with inflammatory markers (CRP-r=-0.675; neutrophil%- r=-0.485) & 6MWD (r=-.428). Categorical variables (MMRC, FEV1 GOLD stages & BODE quartiles) also showed significant difference of fatigue among categories. BODE index & serum CRP were identified as the statistically significant predictors of fatigue, suggesting COPD-RF could be a reflection of severity of underlying pathophysiologic process i.e. systemic inflammation. Conclusion: BODE index and CRP levels are the two important surrogate markers that predicts COPR-RF implying a role of systemic inflammation in the pathogenesis of fatigue. Also COPD-RF could be an indicator of long term prognosis of the disease & should be routinely evaluated during COPD assessment. [ABSTRACT FROM AUTHOR]

Background: The aim of this study is to compare functional outcomes and perioperative complications between patients on a selective serotonin reuptake inhibitor (SSRI) and those who are not on an SSRI preoperatively at the time of total joint arthroplasty.Methods: A retrospective study was performed on 28,386 patients who received a primary total hip (THA) or knee (TKA) arthroplasty. Patients were compared based on SSRI utilization. We measured patient-reported function and health-related quality of life using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) and the EuroQol-5 Dimensions (EQ-5D-5L) instruments. Chi-squared test was used to compare categorical variables and t-test was used to compare the continuous variables of 2 study groups.Results: Patients on SSRIs have lower preoperative baseline WOMAC and EQ-5D-5L scores than those not using SSRI (P < .001). Patient-reported outcomes improved significantly following surgery, but functional outcome scores remained inferior in patients using SSRI. After adjusting for baseline variables, SSRI use in TKA predicted lower EQ-5D-5L scores than non-SSRI users (P = .036) while the WOMAC scores were not different (P = .118). For the THA cohort, SSRI use predicted lower EQ-5D-5L (P = .001) and WOMAC scores than non-SSRI users (P = .008). SSRI use was associated with increased transfusion rate, length of stay, readmission rate, and medical events. About 11.3% of TKA and 13.3% of THA patients stopped using SSRI at 12 months after arthroplasty.Conclusion: Patients using an SSRI show improvement comparable to patients not on an SSRI, but their 12-month functional scores continue to be inferior. SSRI utilization was associated with increased adverse events including needing a blood transfusion. [ABSTRACT FROM AUTHOR]

• It is important to question patient's expectation and benefit from treatment. • Access to clear diagnosis and treatment should be ensured for lymphedema patients. • Function is more important than appearance for most of the lymphedema patient. • Patient education should be considered as a part of the effective treatment to take under control of disease. • Regulations for health insurance are also needed to cover cost of treatment. Lymphedema is characterized by swelling and fibroadipose tissue deposition that is a physically, psychologically, and socially debilitating condition due to chronic and progressive nature of the disease. Treatment benefit evaluation from the patient's perspective is important for medical decision-making. The aim of this study is to investigate important treatment goals and benefits of treatment from the patients' perspective. Eighty-one patients with lymphedema, lipoedema, or lipolymphoedema who are currenlty treated or who underwent previous treatment were included in the study. Socio-demographic data was recorded. Important goals and benefit from treatment were assessed with Patients Needs Questionnaire and Patient Benefit Questionnaire which are sub-questionnaires of Patient Benefit Index-Lymphedema. The most important expectation and needed item was "To find a clear diagnosis and therapy" (n:59, 72%). The least important item for the lymphedema patients was "To feel more attractive" (n:9, 11%). Most beneficial effect of treatment was "To have no fear that the disease will become worse" (n:37, 45.7%). "To have fewer out of pocket treatment expenses" was rated as the least beneficial effect of treatment (n:24, 29.6%). It is important to identify patients' needs and expectations. Patients should be referred for treatment according to their needs. The effectiveness of the treatment should be evaluated objectively. Patient education should be considered as a part of the effective treatment to teach patients how to control their lymphedema. A clear diagnosis and access to treatment should be ensured for lymphedema patients. Regulations for health insurance benefit coverage are needed to cover cost of compression garments. [ABSTRACT FROM AUTHOR]

Abstract Background Patient Reported Outcome Measures (PROMs) are questionnaires that could be used in palliative care (PC) to evaluate patient well-being and monitor their care. PROMs enable a focus on what is important to patients by putting the patient at the center of care. Adapting an existing PROM requires considering cultural differences, general usability and understandability of translated terms. Aim To translate and culturally adapt both the patient and staff three and seven day versions of the Integrated Palliative care Outcome Scale (IPOS) into Estonian. The IPOS consist of 10 questions (staff versions 9 questions) and 17 close ended items. The sub aim is to describe the differences and discrepancies found during the adaptation process and compare the results with previous research. Methods The translation and adaptation process of IPOS was conducted using recommended guidelines consisting of six phases and included cognitive interviews with patients (n = 11) and palliative care multidisciplinary team members (n = 8). The study was conducted in two major Estonian hospitals. Results The Estonian IPOS demonstrated face and content validity, acceptance by patients and staff. As a result of expert group review and cognitive interviews with patients and staff, 9 semantic changes were implemented. Conclusions Patient and staff versions of the IPOS with a recall of 3 or 7 days were translated and culturally adapted for Estonia. The Estonian IPOS four versions are ready for use in Estonia.