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Background: Patients with multiple myeloma (MM) experience disabling symptoms that are difficult to manage and may persist after induction therapy. Monitoring disease-related and induction therapy–induced symptoms and identifying patients at greater risk for high symptom burden are unmet clinical needs. The objective of this study was to examine the trajectories of symptom severity over time and identify predictors of high symptom burden during MM induction therapy. Methodology: Eligible patients with MM rated their symptoms by completing the MD Anderson Symptom Inventory MM module repeatedly during 16 weeks of induction therapy. Group-based trajectory modeling identified patient groups with persistently high-severity (versus low-severity) symptom trajectories over time. Quality of life (QOL) and affective and physical functioning status were assessed. Predictors of high symptom burden were examined by regression analysis. Results: Sixty-four MM patients participated. Most patients (89%) received bortezomib-based therapy. The five most-severe symptom trajectory groups were pain (59%), muscle weakness (46%), numbness (42%), disturbed sleep (41%), and fatigue (31%). Patients in the high-severity trajectory group for the five most-severe symptoms (31% of the sample) were more likely to have high-severity cognitive and affective symptoms. Patients in the high-severity trajectory groups for fatigue, muscle weakness, disturbed sleep, and bone aches were more likely to have high pain scores (all p < 0.05). Significant increases over time were observed in scores for pain (estimate: 0.026), numbness (0.051), muscle weakness (0.020), physical items (0.028), and affective items (0.014) (all p < 0.05). A higher baseline composite score of the five most-severe symptoms predicted worse QOL (− 6.24), and poor affective (0.80) and physical (1.10) statuses (all p < 0.01). Female sex predicted higher risk for being in the high-severity trajectory group for muscle weakness. Conclusion: Almost one-third of MM patients suffer from up to 5 moderate to severe symptoms persistently, including pain, muscle weakness, numbness, disturbed sleep, and fatigue. Importantly, these results identify a group of symptoms that should be monitored and managed as part of routine patient care during MM induction therapy and suggest that pre-therapy pain management is necessary for better symptom control. [ABSTRACT FROM AUTHOR]

Purpose of Review: This review aims to investigate the effect of patient-reported symptom monitoring, defined as the process of active and systematic reporting of symptoms initiated by the patient, on the health-related quality of life of breast cancer patients. Recent Findings: Evidence suggests that online patient-reported symptom monitoring has the potential to positively impact the health-related quality of life of non-metastatic breast cancer patients, who are receiving systemic therapy. However, there is a lack of literature specifically addressing patient-reported symptom monitoring and HRQoL in metastatic breast cancer patients. Summary: Additional research on symptom monitoring and HRQoL in breast cancer patients at all stages and during all phases in the disease trajectory, including its impact on personalized treatment, is needed before integration into routine care can be considered. Validated questionnaires and current implementation frameworks should be used to accelerate knowledge development about symptom monitoring for patients and their healthcare professionals, ultimately enhancing symptom self-management and the efficiency of breast cancer healthcare in the future. [ABSTRACT FROM AUTHOR]

Objectives To assess tolerability of COVID-19 vaccination in patients with RA and controls based on patient-reported outcomes (PROs). Methods In total, 266 study participants were included at 6 ± 1 weeks after their second vaccination (BioNTech/Pfizer (72.2%), AstraZeneca (18.8%) and Moderna (9.0%)). In a cross-sectional, observational study design, PRO data were recorded regarding both total and symptom-level tolerability. Results Overall tolerability was very high according to the patients' self-assessment scores (1.71 for the first and 1.72 for the second vaccination, 6-point Likert scale [1 (very good) to 6 (very poor)]) and did not differ significantly between patients with RA (n  = 204) and controls (n  = 62). Self-rated overall tolerability regarding first vaccination was significantly better (P  = 0.002) in patients receiving mRNA vaccines (n  = 193, mean tolerability 1.59) as compared with vector-vaccinated patients (n  = 73, mean tolerability 2.04). Homologous or heterologous vaccination regimens had no statistically significant effect on vaccine tolerability (P  = 0.131). Reservations about the vaccination were rare (6.4% for the first and 6.0% for the second vaccination) but significantly associated with poorer overall tolerability (P  < 0.001) and significantly reduced willingness to recommend vaccination to others (P  < 0.001 for the first and P  = 0.004 for the second vaccination). Conclusion Based on these real-world data, tolerability of COVID-19 vaccination was very good in both RA patients and controls. Reservations against COVID-19 vaccination were rare overall, but if present, associated with a significantly worse tolerability and a significantly lower degree of recommendation. [ABSTRACT FROM AUTHOR]

Objectives Methods Results Conclusions Patient‐reported outcomes (PROs) have emerged as a valuable tool for aligning HIV care with patient needs and priorities. This study aimed to explore patient and healthcare provider (HCP) experiences of integrating a PRO solution into standard clinical care for HIV in a Danish outpatient clinic.A tailored PRO solution for people living with HIV was developed in a Danish outpatient clinic. Patients were eligible if they were aged >18 years, spoke Danish, had been on effective antiretroviral therapy for 2 years, and had no additional health issues. Patients completed an electronic questionnaire 14 days before in‐clinic consultations. HCPs reviewed patients' responses before these consultations. We assessed the usability, acceptability, and relevance of the PRO solution by conducting semi‐structured interviews with 24 patients (12 responders and 12 non‐responders) and six HCPs. A further 95 non‐responders were interviewed over the phone. Data were analysed using thematic analysis.Respondents found that PROs improved patient–provider communication, treatment planning, and self‐management. Non‐respondents faced barriers such as health literacy, cultural beliefs, and access to technology, necessitating alternative delivery methods. HCPs found that PROs facilitated person‐centred care and symptom management, but HCPs faced challenges such as insufficient training, resources, and organizational support.Implementing PROs in HIV care is challenging because of the patient diversity, clinician training needs, and organizational adaptations. Nevertheless, the use of PROs is associated with enhanced person‐centred care. Future recommendations include tailored use of PROs, better understanding of the impact on patient groups, on‐site questionnaire completion, and emphasis on shared decision‐making between patients and HCPs. [ABSTRACT FROM AUTHOR]

Background: While standard clinical assessments provide great value for people with multiple sclerosis (PwMS), they are limited in their ability to characterize patient perspectives and individual-level symptom heterogeneity. Objectives: To identify PwMS subgroups based on patient-reported outcomes (PROs) of physical, cognitive, and emotional symptoms. We also sought to connect PRO-based subgroups with demographic variables, functional impairment, hypertension and smoking status, traditional qualitative multiple sclerosis (MS) symptom groupings, and neuroperformance measurements. Methods: Using a cross-sectional design, we applied latent profile analysis (LPA) to a large database of PROs; analytic sample N = 6619). Results: We identified nine distinct MS subtypes based on PRO patterns. The subtypes were primarily categorized into low, moderate, and high mobility impairment clusters. Approximately 70% of participants were classified in a low mobility impairment group, 10% in a moderate mobility impairment group, and 20% in a high mobility impairment group. Within these subgroups, several unexpected patterns were observed, such as high mobility impairment clusters reporting low non-mobility impairment. Conclusions: The present study highlights an opportunity to advance precision medicine approaches in MS. Combining PROs with data-driven methodology allows for a cost-effective and personalized characterization of symptom presentations. that can inform clinical practice and future research designs. [ABSTRACT FROM AUTHOR]

Abstract Background Patients with multiple myeloma (MM) experience disabling symptoms that are difficult to manage and may persist after induction therapy. Monitoring disease-related and induction therapy–induced symptoms and identifying patients at greater risk for high symptom burden are unmet clinical needs. The objective of this study was to examine the trajectories of symptom severity over time and identify predictors of high symptom burden during MM induction therapy. Methodology Eligible patients with MM rated their symptoms by completing the MD Anderson Symptom Inventory MM module repeatedly during 16 weeks of induction therapy. Group-based trajectory modeling identified patient groups with persistently high-severity (versus low-severity) symptom trajectories over time. Quality of life (QOL) and affective and physical functioning status were assessed. Predictors of high symptom burden were examined by regression analysis. Results Sixty-four MM patients participated. Most patients (89%) received bortezomib-based therapy. The five most-severe symptom trajectory groups were pain (59%), muscle weakness (46%), numbness (42%), disturbed sleep (41%), and fatigue (31%). Patients in the high-severity trajectory group for the five most-severe symptoms (31% of the sample) were more likely to have high-severity cognitive and affective symptoms. Patients in the high-severity trajectory groups for fatigue, muscle weakness, disturbed sleep, and bone aches were more likely to have high pain scores (all p

Introduction: The safety and efficacy of upadacitinib 15 mg (UPA15) through week 216 was evaluated in patients with rheumatoid arthritis (RA) from the long-term extension (LTE) of the phase 3 SELECT-CHOICE study. Methods: Patients with RA refractory to biologic disease-modifying antirheumatic drugs (bDMARDs) were randomized to UPA15 or abatacept (ABA) for 24 weeks. During the open-label LTE, patients on ABA switched to UPA15 at week 24, and those on UPA15 continued treatment. The safety and efficacy of continuous UPA15, and ABA to UPA15, are summarized through week 216. Results: The LTE was comprised of 91.4% (n = 277/303) of patients that initially received UPA15, and 89.6% (n = 277/309) that initially received ABA. Of patients on UPA15 in the LTE (n = 547), 28.3% (n = 155/547) discontinued the study drug by week 216. Relative to other adverse events of special interest, and largely consistent with previous findings at week 24, higher rates of serious infection, COVID-19, herpes zoster, and elevated creatine phosphokinase were reported, while rates of malignancy excluding nonmelanoma skin cancer (NMSC), NMSC, major adverse cardiovascular event (MACE), and venous thromboembolism (VTE) were low. Long-term safety data with UPA through week 216 aligned with previous observations and no new safety risks were identified, including in patients who switched from ABA to UPA15. Proportions of patients achieving 28-joint disease activity score based on C-reactive protein (DAS28[CRP]) < 2.6/ ≤ 3.2, clinical disease activity index (CDAI) and simple disease activity index (SDAI) low disease activity/remission, ≥ 20%/50%/70% improvement in the American College of Rheumatology (ACR20/50/70) response criteria, and Boolean remission were maintained or improved with UPA15 through week 216. Improvements in the Health Assessment Questionnaire-Disability Index (HAQ-DI), patient's assessment of pain, and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) were also maintained or improved with UPA15 through week 216. Across all efficacy endpoints, similar results were observed in patients who switched from ABA to UPA15 versus continuous UPA15. Patients with an inadequate response to ≥ 1 prior tumor necrosis factor (TNF) inhibitor (UPA15: n = 263/303, 86.8%; ABA to UPA15: n = 273/309, 88.3%) showed similar responses to the total population. Conclusions: The long-term safety profile of UPA was consistent with previous findings and the broader RA clinical program. Compared to the primary analyses at week 24, efficacy responses were maintained or further improved with UPA15 through week 216 in patients with RA. Trial registration, ClinicalTrials.gov identifier: NCT03086343. Plain Language Summary: A long-term study looked at a drug named upadacitinib to treat people with rheumatoid arthritis (RA), a disease that causes joint pain and damage. The study included patients whose RA was not improved by other injectable medicines. The study compared upadacitinib with another drug called abatacept. After 24 weeks, patients who were taking abatacept switched to upadacitinib, and patients taking upadacitinib continued on upadacitinib treatment for over 4 years. The researchers looked at how well the treatments worked over the long-term and if there were any side effects. The side effects with upadacitinib treatment in this long-term study were similar to side effects reported in previous studies with upadacitinib. The researchers also found that upadacitinib helped to lessen the symptoms of RA over time and helped patients complete their daily activities and reduced their pain and tiredness. This was true for patients who switched from abatacept to upadacitinib after 24 weeks and for patients who took upadacitinib from the start of the study. Patients who had not responded to other medicines also had similar improvements with upadacitinib. In conclusion, upadacitinib can help people with RA over the long term and no new safety risks were found. [ABSTRACT FROM AUTHOR]

Purpose: The evaluation of treatment success and progression in oncology patient-reported outcomes (PROs) is playing an increasingly important role. Meanwhile, PROs are a component of the certification requirements of the German Cancer Society for oncology centers. PROs are used to provide supportive therapy. There is currently no instrument that fully covers the requirements. At the University Hospital Regensburg (UKR), a digital ONCOlogical-ROUTinE-Screening (ONCO-ROUTES) procedure was developed in order to assess the need for supportive therapy in a standardized way and to provide patients with supportive interventions tailored to their needs. Methods: On the basis of current requirements and guidelines, the development of ONCO-ROUTES was supported by experts in focus groups and interviews, and digitalization was carried out in connection with the IT infrastructure. Results: A Needs-based, Quality-of-life (QoL) and Symptoms Screening (NQS2) tool already established in the routine at the UKR was further developed into ONCO-ROUTES, which is made up of the domains therapy phase, nutrition, tobacco use, alcohol use, quality of life, general condition/functional status, physical activity, psychooncology, social services, and further support needs. By linking the digitized questionnaire to the hospital information system, the results are available for immediate use in routine operations and thus for the referral of patients for further supportive therapy. Conclusion: The digital PRO application ONCO-ROUTES is designed to involve patients in monitoring additional supportive needs and thus, improves supportive interdisciplinary treatment. [ABSTRACT FROM AUTHOR]

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Abstract Introduction The safety and efficacy of upadacitinib 15 mg (UPA15) through week 216 was evaluated in patients with rheumatoid arthritis (RA) from the long-term extension (LTE) of the phase 3 SELECT-CHOICE study. Methods Patients with RA refractory to biologic disease-modifying antirheumatic drugs (bDMARDs) were randomized to UPA15 or abatacept (ABA) for 24 weeks. During the open-label LTE, patients on ABA switched to UPA15 at week 24, and those on UPA15 continued treatment. The safety and efficacy of continuous UPA15, and ABA to UPA15, are summarized through week 216. Results The LTE was comprised of 91.4% (n = 277/303) of patients that initially received UPA15, and 89.6% (n = 277/309) that initially received ABA. Of patients on UPA15 in the LTE (n = 547), 28.3% (n = 155/547) discontinued the study drug by week 216. Relative to other adverse events of special interest, and largely consistent with previous findings at week 24, higher rates of serious infection, COVID-19, herpes zoster, and elevated creatine phosphokinase were reported, while rates of malignancy excluding nonmelanoma skin cancer (NMSC), NMSC, major adverse cardiovascular event (MACE), and venous thromboembolism (VTE) were low. Long-term safety data with UPA through week 216 aligned with previous observations and no new safety risks were identified, including in patients who switched from ABA to UPA15. Proportions of patients achieving 28-joint disease activity score based on C-reactive protein (DAS28[CRP])

Patient‐reported outcomes (PROs) are closely related to the delivery of high‐quality care and services. Patient‐reported outcome measures (PROMs) are the tools used to measure the PROs. Despite the challenges and barriers associated with using PROs and PROMs, measuring PROs is valuable for a patient's health status and advancing evidence‐based medicine. Real‐world implementation of PROMs may especially open possibilities for healthcare systems under reform, such as Saudi Arabia. This paper highlights the concepts of PROs and PROMs. Moreover, it distinguishes between PROs and other concepts such as patient experience, quality of life, and patient satisfaction. It also explores the available literature in Saudi Arabia and the world regarding PROs and their role in improving healthcare systems. Last, this paper advocates for utilizing the national and comprehensive tools of PROMS in different levels and disciplines. Key points: Patient‐reported outcomes provide an opportunity to engage patients in their care, enhance shared decision making, and improve care effectively and safely.Integrating patient‐reported outcome measures (PROMs) in patient care has been associated with improving patient safety and patient experience and helping achieve more patient‐centered care.Related literature demonstrated some limitations that might hinder the effective implementation of PROMs, related to the integrity of data and lack of methodological standardization of PROMs data.Patient‐reported outcomes are poorly addressed within the Saudi literature, and the utilization of PROs is also underdeveloped and needs further consideration.There is an excellent opportunity for researching and implementing PROMs in the healthcare setting in Saudi Arabia, which is currently undergoing a major transformation. [ABSTRACT FROM AUTHOR]

Spine tumors, both primary and metastatic, impose significant morbidity and mortality on patients and physicians. Patient-reported outcomes are valuable tools to assess a patient's impression of their health status and enhance communication between physicians and patients. Various spine generic patient-reported outcome tools have traditionally been used but have not been validated in the spine tumor patient population. The Spine Oncology Study Group Outcome Questionnaire, which is disease-specific for the metastatic spine patient population, has been shown to have strong validity, even across multiple languages. Patient-Reported Outcomes Measurement Information System, which has recently been developed, employs computerized adaptive testing to assess multiple health domains. It has been shown to capture information in both generic and specific questionnaires and has the potential to be used as a universal tool in the spine oncology patient population. Further long-term studies, as well as, cross-cultural adaptations, are needed to validate Patient-Reported Outcomes Measurement Information System's applicability and effectiveness. [ABSTRACT FROM AUTHOR]

Purpose of Review: Treatment guided by periodic and quantitative data assessment results in better outcomes compared to using clinical gestalt. While validated generic as well as specific disease activity measures for axial spondyloarthritis (axSpA) are available, there is vast scope to improve their actual utilization in routine clinical practice. In this review, we discuss available disease activity measures for axSpA, describe results from the survey conducted among general rheumatologists as well as Spondyloarthritis Research and Treatment Network (SPARTAN) members about disease activity measurement in daily practice, and discuss ways to improve axSpA disease activity using technological advances. We also discuss the definitions of active disease and target for the treatment of axSpA. Recent Findings: The 2019 American College of Rheumatology (ACR)/Spondylitis Association of America (SAA)/Spondyloarthritis Research and Treatment Network (SPARTAN) axSpA treatment guidelines conditionally recommend the regular monitoring of disease activity using a validated measure such as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) or Ankylosing Spondylitis Disease Severity Index (ASDAS). Assessment of Spondyloarthritis International Society (ASAS)-European Alliance of Associations for Rheumatology (EULAR) guidelines recommend ASDAS as the most appropriate instrument for the assessment of disease activity, preferably calculated using C-reactive protein (CRP). ASAS has selected a core set of variables which were updated recently and have been endorsed by the Outcome Measures in Rheumatology Clinical Trials (OMERACT) group in order to bring homogeneity in assessment of axSpA. In a recent study, Patient-Reported Outcomes Measurement Information System (PROMIS®) measures were able to discriminate inactive, moderate, and high–very high ASDAS activity groups. A newly developed semi-objective index P4 (pain, physical function, patient global, and physician global) correlates well with BASDAI and ASDAS in axSpA and can also be used for other rheumatic diseases in busy clinical practices. Summary: Regular disease activity monitoring is critical for long-term management of axSpA and shared decision-making. The integration of electronic health records and smart devices provides a great opportunity to capture patient-reported data. Automated capture of electronic patient-reported outcome measures (ePROMs) is a highly efficient way and results in consistent regular monitoring and may improve the long-term outcomes. While currently used measures focus only on musculoskeletal symptoms of axSpA, a composite disease activity measure that can also incorporate extra-articular manifestations may provide a better assessment of disease activity. [ABSTRACT FROM AUTHOR]

Abstract Background Chronic hepatitis C virus (HCV) infection negatively impacts health-related quality of life (HRQL). We aimed to assess patient-reported outcomes (PROs) to evaluate the impact of treating chronic HCV with directly acting antivirals (DAAs) on HRQL. Methods PROs were assessed prospectively using the PROQOL-HCV questionnaire before (week 0), at the end (week 12), and after DAA treatment at week 24. HRQL was measured in six different dimensions: physical health, emotional health, future uncertainty, intimate relationships, social health, and cognitive functions. Results A total of 500 HCV patients receiving DAAs were enrolled; of them, 399 were included in the analysis (median age 57 years, 59% females). HRQL increased significantly between baseline, end of treatment, and week 24 for all dimensions (P

Purpose: This study examines providers’ and clinic staff’s perspectives on patient-reported outcomes (PROs) implementation at an academic medical center. Methods: An anonymous and voluntary survey was administered to Henry Ford Cancer providers and clinic staff 18 months after PROs program implementation in September 2020, to obtain their feedback on perceived barriers, impact on workflows, and PROs administration frequency in routine cancer care. Results: A total of 180 providers and 40 clinic staff were invited to complete the survey; 31% and 63% completed the survey, respectively. Approximately 68% of providers reported that electronically integrated PROs scores were either beneficial or somewhat beneficial to their patients, while only 28% of the clinic staff reported that PROs were beneficial or somewhat beneficial to patients. According to the clinic staff, the most common barriers to PROs completion included lack of patients’ awareness of the utility of the program with respect to their care, patients’ health status at check-in, and PROs being offered too frequently. Conclusion: There is favorable acceptance of the PROs program by providers, but clinic staff found it less favorable. Interventions to address barriers and improve program engagement are needed to ensure broad adoption of PROs in oncology practice. [ABSTRACT FROM AUTHOR]

Purpose: As life expectancy continues to rise, post-treatment health-related quality of life (HRQoL) of breast cancer patients becomes increasingly important. This study examined the one-year longitudinal relation between axillary treatments and physical, psychosocial, and sexual wellbeing and arm symptoms. Methods: Women diagnosed with breast cancer who received different axillary treatments being axilla preserving surgery (APS) with or without axillary radiotherapy or full axillary lymph node dissection (ALND) with or without axillary radiotherapy were included. HRQoL was assessed at baseline, 6- and 12-months postoperatively using the BREAST-Q and the European Organization for Research and Treatment of Cancer QoL Questionnaire Breast Cancer Module (EORTC QLQ-BR23). Mixed regression models were constructed to assess the impact of axillary treatment on HRQoL. HRQoL at baseline was compared to HRQoL at 6- and at 12-months postoperatively. Results: In total, 552 patients were included in the mixed regressions models. Except for ALND with axillary radiotherapy, no significant differences in physical and psychosocial wellbeing were found. Physical wellbeing decreased significantly between baseline and 6- and 12-months postoperatively (p < 0.001, p = 0.035) and psychosocial wellbeing decreased significantly between baseline and 12 months postoperatively (p = 0.028) for ALND with axillary radiotherapy compared to APS alone. Arm symptoms increased significantly between baseline and 6 months and between baseline and 12 months postoperatively for APS with radiotherapy (12.71, 13.73) and for ALND with radiotherapy (13.93, 16.14), with the lowest increase in arm symptoms for ALND without radiotherapy (6.85, 7.66), compared to APS alone (p < 0.05). Conclusion: Physical and psychosocial wellbeing decreased significantly for ALND with radiotherapy compared to APS alone. Shared decision making and expectation management pre-treatment could be strengthened by discussing arm symptoms per axillary treatment with the patient. Plain English summary: Breast cancer is one of the most common cancers among women worldwide. Since the survival rates are improving, the health-related quality of life of breast cancer patients after treatment becomes more important. One of the most important factors in the prognosis of breast cancer patients is the presence of axillary metastasis, the spread of breast cancer to lymph nodes in the armpit. There are different axillary treatments which can all affect health-related quality of life negatively. Therefore, the aim of this study is to examine the effect of different axillary treatments on physical, psychosocial, and sexual wellbeing and arm symptoms of breast cancer patients. This study included women with breast cancer who received either axillary preserving surgery with or without axillary radiotherapy, or a full axillary lymph node dissection with or without axillary radiotherapy. health-related quality of life was assessed with validated breast cancer specific questionnaires at baseline, 6- and 12-months postoperatively. Patients who underwent axilla preserving surgery without axillary radiotherapy experienced significantly less decline in both physical and psychosocial wellbeing as well as significantly fewer increase in arm symptoms compared to patients who received the more extensive axillary treatments. The results of this study can be used to improve shared decision making and expectation management for future breast cancer patients.b [ABSTRACT FROM AUTHOR]

Abstract Background Patient-reported outcomes (PROs) play a crucial role in assessing rheumatic diseases, offering insights into disease evaluation and treatment efficacy. This study focuses on PRO assessment in large vessel vasculitides, including Takayasu Arteritis and Giant Cell Arteritis (GCA). Methods We retrospectively analyzed routine data from patients treated at our rheumatology clinic over a 10-year span. Patient and physician-rated global disease activity scale (G-DAS) scores, measured on a numeric rating scale (0–10 points), were collected at each visit. Clinical variables like age, sex, body mass index (BMI), disease duration, lab values, pain perception, and questionnaire responses were recorded. Linear regression and generalized additive linear regression (GAM analysis) examined associations between PROs and these factors. Results The study included 138 patients, primarily diagnosed with GCA (94.4%). Mean follow-up was 2.5 years (0-7.7). Patient and physician G-DAS exhibited a moderate correlation (Pearson R 0.19, CI 0.14–0.24, p

Abstract Background Later stage chronic kidney disease (CKD) is associated with poorer self-perceived health-related quality of life (HRQOL), a major consideration for many patients. Psychological factors such as depression and anxiety have been linked with poorer HRQOL. We aimed to determine if anxiety or depressive symptoms are significantly associated with self-perceived health-related quality of life, in patients with CKD Stage 5. The secondary aim was to determine which patient-associated factors are associated with HRQOL in patients with CKD Stage 5. Methods This retrospective cross-sectional study included patients that attended the St George Hospital Kidney Supportive Care (KSC) clinic between 1 and 2015 and 30 June 2022 with CKD Stage 5 (either conservatively-managed or receiving dialysis). Patients completed surveys of their functional ‘domains’ and quality of life (EQ-5D-5L) and symptom surveys (IPOS-Renal) at their first visit. We performed multivariable linear regression analysis with the outcome of interest being HRQOL, measured using the EQ-VAS, a continuous 100-point scale, for patients undergoing conservative management or dialysis. Pre-specified variables included age, sex, eGFR (for those conservatively-managed), “feeling depressed” (IPOS-Renal), “feeling anxious” (IPOS-Renal) and “anxiety/depression” (EQ-5D-5L). Results We included 339 patients. 216 patients received conservative kidney management (CKM) and 123 patients received dialysis. Patients receiving CKM were significantly older than those on dialysis, (median age 83 years vs. 73 years, p

Abstract Introduction Adoptive cell therapy (ACT) is a rapidly evolving field. Patient-reported outcomes (PROs) allow patients to report the impact of treatment on their quality of life during and after treatment. The systematic review aims to characterise the breadth of PROs utilised in ACT cancer care and provide guidance for the use of PROs in this patient population in the future. Methods A systematic search was conducted (MEDLINE, PsycINFO, Embase and CINAHL) in August 2021 by two reviewers. Search terms covered the following: “adoptive cell therapy”, “patient-reported outcomes” and “cancer”. Studies were included if they used a PRO measure to report the impact of ACT. The methodological quality of PROs was assessed. Forward and backward reference searching was conducted of any relevant papers. A quality grading scale was applied based on Cochrane and Revenson criteria for classification of high-quality studies. Key data from the studies and the included PROs was extracted by two researchers and tabulated. Results One-hundred nine papers were identified; 11 papers were included. The majority of studies were single-arm trials or observational studies. Twenty-two different PROs were identified; none was ACT specific. The PROMIS-29 and EQ-5D were most commonly used. Few studies collected PRO data in the first 1–2 weeks. Four studies followed patients up for over a year, and a further four studies followed patients for approximately 3 months. Discussion None of the PROs identified have been designed specifically for ACT. Appropriateness of existing instruments should be considered. It should be considered whether it is appropriate to collect data more frequently in the acute stage and then less frequently during follow-up. It should be considered if one tool is suitable at all time points or if the tool should be adapted depending on time since treatment. More research is needed to identify the exact timings of PRO assessments, and qualitative work with patients is needed to determine the most important issues for them throughout the treatment and follow-up.

Neurological medical devices have revolutionized the management of neurological disorders, providing diagnostic, therapeutic, and monitoring solutions. High-risk neurological devices, such as deep brain stimulation and neurostimulators, offer groundbreaking treatments, emphasizing patient benefits while considering risks. To gain FDA approval, high-risk Class III devices necessitate premarket approval (PMA) applications with pivotal clinical trials, often assessing patient-reported outcomes (PROs). This article analyzes FDA-approved high-risk neurological devices from 2001 to 2022 via the PMA pathway. It explores device characteristics and pivotal clinical trials, and PRO incorporation. Of the 23 identified devices, pain neurology devices (30.4 %) predominated. All devices were therapeutic, with varying study designs. Pain neurology devices notably emphasized PRO endpoints as expected. This study underscores the significance of PROs in assessing device efficacy and safety, offering insights into regulatory processes and patient-centered care in neurological disorder management.

Objectives: Thoracic outlet syndrome (TOS) is an uncommon neurovascular disorder that presents as neck and upper extremity pain secondary to brachial plexus trunk or subclavian vasculature compression. The orthopedic literature has correlated patient-reported allergies to postoperative patient-reported outcome (PRO) scores for a variety of surgical procedures. We sought to evaluate patient-reported allergies and PROs following surgical decompression for TOS. Methods: A chart review was conducted after identifying patients who underwent surgical thoracic outlet decompression by a single surgeon. Patients were contacted and administered five PRO questionnaires via telephone: the QuickDASH Outcome Measure questionnaire (disabilities of the arm, shoulder, and hand [DASH]), the Cervical Brachial Symptom Questionnaire, the Single Assessment Numeric Evaluation, the 12-Item Short Form Survey, and the Numeric Rating Scale (a visual analogue scale). A bivariate analysis of Pearson’s correlation coefficient (r) was used to determine the associations of allergies with questionnaires and demographic variables. Results: Of the 393 patients (128 males and 265 females) identified in the study, 75 (24%) responded and completed all of the questionnaires, 18 (24%) males and 57 (76%) females. A significant correlation was found between the number of allergies reported and the QuickDASH Outcome Measure questionnaire (r = 0.375, P < 0.001), the Cervical Brachial Symptom Questionnaire (r = 0.295, P = 0.01), change in the Single Assessment Numeric Evaluation score (r = −0.310, P < 0.01), change in the visual analogue scale (r = 0.244, P = 0.035), sex (r = 0.245, P = 0.034), and the number of medications (r = 0.642, P < 0.001). Conclusions: The increased frequency of patient-reported allergies is significantly associated with worse PRO scores for women undergoing TOS surgical decompression. Better understanding this association can help physicians counsel patients on expected outcomes. [ABSTRACT FROM AUTHOR]

Background: Ankle sprains are a common musculoskeletal injury among the general population and often involve the lateral ligament complex. Although the majority of ankle sprains are treated successfully with nonsurgical conservative measures, an estimated 5% to 20% of ankle injuries ultimately develop chronic lateral ankle instability (CAI). Multiple surgical treatment modalities for the lateral ankle complex exist, such as anatomical and nonanatomical reconstruction. The current gold standard for primary surgical repair is the Broström-Gould procedure. This is the first article to provide PROMIS scores following BG and the largest study with 5-year outcomes for an open BG. Methods: This was a descriptive study of a retrospective cohort of patients undergoing a BG with a minimum followup of 5 years. Patient-reported outcome instruments collected postoperatively were PROMIS Pain, Physical Function, Depression, and FAAM. Further preoperative clinic characteristics were analyzed to correlate with the final outcome. The electronic medical record was queried for Current Procedural Terminology (CPT) code 27698 (Broström-Gould) from January 2010 to June 2017. Surveys were conducted in the clinic and through phone interviews. Patient charts were reviewed to obtain basic patient demographic information including sex, age, race, and body mass index (BMI). The following preoperative variables were recorded: history of prior CAI procedures, history of major trauma, duration of symptoms, number of diagnosed ankle sprains, other collagen pathologies, generalized ligament laxity, participation in sports/activity level, peroneal subluxation, clinically diagnosed peroneus longus or brevis tendinopathy, deltoid ligament injury, anterior ankle impingement, and posterior ankle impingement. The PROMIS and Foot and Ankle Ability Measure (FAAM) scores were obtained with a combination of clinic and phone interviews. Data were aggregated in Microsoft Excel and entered in R (version 4.2.0) for statistical analysis. Results: Our results show that the minimum 5-year patient-reported PROMIS scores for patients following a Broström-Gould procedure are as follows: PROMIS physical function, 50.5; PROMIS pain interference, 48.2; and PROMIS depression, 38.2. This indicates, at a minimum, that patients 5 years removed from the procedure are within 1 SD of the general population in regard to PROMIS physical function and pain. Our patient-reported FAAM, activities of daily living, and FAAM sports scores were 59.6 and 13.0 respectively. Preoperative magnetic resonance imaging (MRI) findings were recorded. Arthroscopic examination was performed before lateral ligaments reconstruction for patients with intra-articular pathologies confirmed on MRI. Conclusion: The findings from our study offer evidence supporting the effectiveness of the Broström-Gould procedure to be associated with normal physical function, even 5 years after surgery. Furthermore, our research identified specific factors such as tobacco use, diabetes, and sports participation that independently correlated with reported outcome measures. These insights enable physicians to better manage patient expectations and tailor treatment strategies accordingly. Our study establishes a foundation for future prospective research endeavors that aim to leverage the PROMIS system for comprehensive outcome assessments. [ABSTRACT FROM AUTHOR]

Living with chronic hepatitis B (CHB) has physical, social, and emotional impacts that often negatively affect patients' quality of life. These impacts are not usually captured during routine care. This article presents information on the impact of living with CHB and the importance of integrating health-related quality-of-life assessment into CHB care. Using a global online survey, people ages ≥18 living with CHB were asked about physical, social, and worry impacts. Of 1707 respondents, most were male (67%), < 45 years of age (81%); and 52% identified as Black. Of all participants, 66% reported physical impact, 55% reported social impact, and 49% reported worry impact of living with CHB. Those from Africa and the Western Pacific were most likely to report physical impact. Younger participants (18-45) and those not on treatment were significantly more likely to report physical and social impact. People living with CHB are impacted physically, socially, and emotionally, varied by demographic factors and disease experience. These impacts should be captured and addressed as part of routine CHB care. [ABSTRACT FROM AUTHOR]

Abstract Background There has been an increased significance on patient-reported outcomes in clinical settings. We aimed to evaluate the feasibility of administering patient-reported outcome measures by computerized adaptive testing (CAT) using a tablet computer with rehabilitation inpatients, assess workload demands on staff, and estimate the extent to which rehabilitation inpatients have elevated T-scores on six Patient Reported Outcomes Measurement Information System® (PROMIS®) measures. Methods Patients (N = 108) with stroke, spinal cord injury, traumatic brain injury, and other neurological disorders participated in this study. PROMIS computerized adaptive tests (CAT) were administered via a web-based platform. Summary scores were calculated for six measures: Pain Interference, Sleep Disruption, Anxiety, Depression, Illness Impact Positive, and Illness Impact Negative. We calculated the percent of patients with T-scores equivalent to 2 standard deviations or greater above the mean. Results During the first phase, we collected data from 19 of 49 patients; of the remainder, 61% were not available or had cognitive or expressive language impairments. In the second phase of the study, 40 of 59 patients participated to complete the assessment. The mean PROMIS T-scores were in the low 50 s, indicating an average symptom level, but 19–31% of patients had elevated T-scores where the patients needed clinical action. Conclusions The study demonstrated that PROMIS assessment using a CAT administration during an inpatient rehabilitation setting is feasible with the presence of a research staff member to complete PROMIS assessment.

Background: Later stage chronic kidney disease (CKD) is associated with poorer self-perceived health-related quality of life (HRQOL), a major consideration for many patients. Psychological factors such as depression and anxiety have been linked with poorer HRQOL. We aimed to determine if anxiety or depressive symptoms are significantly associated with self-perceived health-related quality of life, in patients with CKD Stage 5. The secondary aim was to determine which patient-associated factors are associated with HRQOL in patients with CKD Stage 5. Methods: This retrospective cross-sectional study included patients that attended the St George Hospital Kidney Supportive Care (KSC) clinic between 1 and 2015 and 30 June 2022 with CKD Stage 5 (either conservatively-managed or receiving dialysis). Patients completed surveys of their functional 'domains' and quality of life (EQ-5D-5L) and symptom surveys (IPOS-Renal) at their first visit. We performed multivariable linear regression analysis with the outcome of interest being HRQOL, measured using the EQ-VAS, a continuous 100-point scale, for patients undergoing conservative management or dialysis. Pre-specified variables included age, sex, eGFR (for those conservatively-managed), "feeling depressed" (IPOS-Renal), "feeling anxious" (IPOS-Renal) and "anxiety/depression" (EQ-5D-5L). Results: We included 339 patients. 216 patients received conservative kidney management (CKM) and 123 patients received dialysis. Patients receiving CKM were significantly older than those on dialysis, (median age 83 years vs. 73 years, p < 0.001). For conservatively-managed patients, variables independently associated with poorer EQ-VAS were difficulty performing usual activities (EQ-5D-5L), drowsiness (IPOS-Renal) and shortness of breath (IPOS-Renal). For patients receiving dialysis, variables that were independently associated with poorer EQ-VAS were reduced ability to perform self-care (EQ-5D-5L) and lack of energy (IPOS-Renal). Anxiety and depressive symptoms were not significantly associated with poorer EQ-VAS for either group of patients. Conclusions: Symptoms associated with reduced HRQOL include shortness of breath, drowsiness and impaired functional ability. Optimization of multidisciplinary teams focusing on these issues are likely to be of benefit. [ABSTRACT FROM AUTHOR]

Introduction: Adoptive cell therapy (ACT) is a rapidly evolving field. Patient-reported outcomes (PROs) allow patients to report the impact of treatment on their quality of life during and after treatment. The systematic review aims to characterise the breadth of PROs utilised in ACT cancer care and provide guidance for the use of PROs in this patient population in the future. Methods: A systematic search was conducted (MEDLINE, PsycINFO, Embase and CINAHL) in August 2021 by two reviewers. Search terms covered the following: "adoptive cell therapy", "patient-reported outcomes" and "cancer". Studies were included if they used a PRO measure to report the impact of ACT. The methodological quality of PROs was assessed. Forward and backward reference searching was conducted of any relevant papers. A quality grading scale was applied based on Cochrane and Revenson criteria for classification of high-quality studies. Key data from the studies and the included PROs was extracted by two researchers and tabulated. Results: One-hundred nine papers were identified; 11 papers were included. The majority of studies were single-arm trials or observational studies. Twenty-two different PROs were identified; none was ACT specific. The PROMIS-29 and EQ-5D were most commonly used. Few studies collected PRO data in the first 1–2 weeks. Four studies followed patients up for over a year, and a further four studies followed patients for approximately 3 months. Discussion: None of the PROs identified have been designed specifically for ACT. Appropriateness of existing instruments should be considered. It should be considered whether it is appropriate to collect data more frequently in the acute stage and then less frequently during follow-up. It should be considered if one tool is suitable at all time points or if the tool should be adapted depending on time since treatment. More research is needed to identify the exact timings of PRO assessments, and qualitative work with patients is needed to determine the most important issues for them throughout the treatment and follow-up. [ABSTRACT FROM AUTHOR]

Electronic patient‐reported outcome (ePRO) programs may offer advantages for patients with cancer, clinicians, health care systems, payors, and society in general; but developing and maintaining an ePRO program will require cancer centers to navigate defining meaningful problems, collecting ePROs, implementing action when those ePROs require intervention without over‐burdening clinicians, and monitoring the successes and failures of their ePRO programs. Physician informaticists from the National Comprehensive Cancer Network Electronic Health Record Advisory Group offer 10 guiding principles to consider when contemplating, building, or refining an ePRO program for patients with cancer. [ABSTRACT FROM AUTHOR]

Simple Summary: One barrier to implementing patient-reported outcomes (PROs) during perioperative care for bladder cancer (BLC) patients is the lack of empirical reports of meaningful symptom burden that are associated with postoperative recovery. This study aimed to describe symptom burden and functioning status for 3 months post-radical cystectomy, using a validated disease-specific PRO measure tool, the MD Anderson Symptom Inventory (the MDASI-PeriOp-BLC). We found that the most severe symptom burden at baseline and discharge is associated with poor functional recovery post-radical cystectomy for BLC. These PROs could be used to identify BLC patients at the highest risk for poor functional recovery during the perioperative period. We also found that postoperative functional recovery assessment via PROs is more feasible than an objective performance measure. The completion of MDASI-PeriOp-BLC at preoperative, discharge and end of study was 100%, 79% and 77%, while Timed Up and Go test completion rates were 88%, 54% and 13%, respectively. This is a longitudinal prospective study that tracked multiple symptom burden and functioning status for bladder cancer (BLC) patients for 3 months post-radical cystectomy at The University of Texas MD Anderson Cancer Center, using a validated disease-specific patient-reported outcome measure (PROM) tool, the MD Anderson Symptom Inventory (the MDASI-PeriOp-BLC). The feasibility of collecting an objective measure for physical functioning, using "Timed Up & Go test" (TUGT) and PRO scores at baseline, discharge and end of study, was tested. Patients (n = 52) received care under an ERAS pathway. The more severe scores of fatigue, sleep disturbance, distress, drowsiness, frequent urination and urinary urgency at baseline predicted poor functional recovery postoperatively (OR = 1.661, 1.039–2.655, p = 0.034); other more severe symptoms at discharge (pain, fatigue, sleep disturbance, lack of appetite, drowsiness, bloating/abdominal tightness) predicted poor functional recovery (OR = 1.697, 1.114–2.584, p = 0.014) postoperatively. Compliance rates at preoperative, discharge and end of study were 100%, 79% and 77%, while TUGT completion rates were 88%, 54% and 13%, respectively. This prospective study found that more severe symptom burden at baseline and discharge is associated with poor functional recovery post-radical cystectomy for BLC. The collection of PROs is more feasible than using performance measures (TUGT) of function following radical cystectomy. [ABSTRACT FROM AUTHOR]

Background: There has been an increased significance on patient-reported outcomes in clinical settings. We aimed to evaluate the feasibility of administering patient-reported outcome measures by computerized adaptive testing (CAT) using a tablet computer with rehabilitation inpatients, assess workload demands on staff, and estimate the extent to which rehabilitation inpatients have elevated T-scores on six Patient Reported Outcomes Measurement Information System® (PROMIS®) measures. Methods: Patients (N = 108) with stroke, spinal cord injury, traumatic brain injury, and other neurological disorders participated in this study. PROMIS computerized adaptive tests (CAT) were administered via a web-based platform. Summary scores were calculated for six measures: Pain Interference, Sleep Disruption, Anxiety, Depression, Illness Impact Positive, and Illness Impact Negative. We calculated the percent of patients with T-scores equivalent to 2 standard deviations or greater above the mean. Results: During the first phase, we collected data from 19 of 49 patients; of the remainder, 61% were not available or had cognitive or expressive language impairments. In the second phase of the study, 40 of 59 patients participated to complete the assessment. The mean PROMIS T-scores were in the low 50 s, indicating an average symptom level, but 19–31% of patients had elevated T-scores where the patients needed clinical action. Conclusions: The study demonstrated that PROMIS assessment using a CAT administration during an inpatient rehabilitation setting is feasible with the presence of a research staff member to complete PROMIS assessment. [ABSTRACT FROM AUTHOR]

Common symptoms of overt hypothyroidism are non-specific and include fatigue, lethargy, and dry skin. Although the diagnosis is considered to be straightforward, no single symptom can be used to identify patients with overt hypothyroidism, while many patients with subclinical hypothyroidism are asymptomatic. A large population-based study on the spectrum of symptoms in subclinical hypothyroidism showed similar rates of thyroid disease-related symptoms compared with euthyroid subjects, while the TSH concentration had no impact on symptom score. Together, these findings make it challenging to attribute symptoms to their underlying cause. This is also true in the case of unexplained persistent symptoms in levothyroxine-treated patients. Although generally considered a life-long replacement therapy, successful thyroid hormone discontinuation resulting in euthyroidism has been reported in approximately one third of patients. Thus, we overtreat patients with (subclinical) hypothyroidism, highlighting the importance of reliable diagnostic criteria. The diagnostic process, including the implementation of robust TSH and FT4 reference intervals, is especially challenging in specific situations including aging, pregnancy, non-thyroidal illness, and central hypothyroidism. There is a clear need for improved adherence to current guidelines from scientific societies and for willingness to manage symptoms without a clear pathological correlate, especially in the case of mild TSH elevations. This review will highlight recent literature on this topic and offers some practice points. [ABSTRACT FROM AUTHOR]

Abstract Background Many cancer patients experience high symptom burden. Healthcare in the USA is reactive, not proactive, and doctor-patient communication is often suboptimal. As a result, symptomatic patients may suffer between clinic visits. In research settings, systematic assessment of electronic patient-reported outcomes (ePROs), coupled with clinical responses to severe symptoms, has eased this symptom burden, improved health-related quality of life, reduced acute care needs, and extended survival. Implementing ePRO-based symptom management programs in routine care is challenging. To study methods to overcome the implementation gap and improve symptom control for cancer patients, the National Cancer Institute created the Cancer-Moonshot funded Improving the Management of symPtoms during And following Cancer Treatment (IMPACT) Consortium. Methods Symptom Management IMplementation of Patient Reported Outcomes in Oncology (SIMPRO) is one of three research centers that make up the IMPACT Consortium. SIMPRO, a multi-disciplinary team of investigators from six US health systems, seeks to develop, test, and integrate an electronic symptom management program (eSyM) for medical oncology and surgery patients into the Epic electronic health record (EHR) system and associated patient portal. eSyM supports real-time symptom tracking for patients, automated clinician alerts for severe symptoms, and specialized reports to facilitate population management. To rigorously evaluate its impact, eSyM is deployed through a pragmatic stepped wedge cluster-randomized trial. The primary study outcome is the occurrence of an emergency department treat-and-release event within 30 days of starting chemotherapy or being discharged following surgery. Secondary outcomes include hospitalization rates, chemotherapy use (time to initiation and duration of therapy), and patient quality of life and satisfaction. As a type II hybrid effectiveness-implementation study, facilitators and barriers to implementation are assessed throughout the project. Discussion Creating and deploying eSyM requires collaboration between dozens of staff across diverse health systems, dedicated engagement of patient advocates, and robust support from Epic. This trial will evaluate eSyM in routine care settings across academic and community-based healthcare systems serving patients in rural and metropolitan locations. This trial’s pragmatic design will promote generalizable results about the uptake, acceptability, and impact of an EHR-integrated, ePRO-based symptom management program. Trial registration ClinicalTrials.gov NCT03850912 . Registered on February 22, 2019. Last updated on November 9, 2021.

Common symptoms of overt hypothyroidism are non-specific and include fatigue, lethargy, and dry skin. Although the diagnosis is considered to be straightforward, no single symptom can be used to identify patients with overt hypothyroidism, while many patients with subclinical hypothyroidism are asymptomatic. A large population-based study on the spectrum of symptoms in subclinical hypothyroidism showed similar rates of thyroid disease-related symptoms compared with euthyroid subjects, while the TSH concentration had no impact on symptom score. Together, these findings make it challenging to attribute symptoms to their underlying cause. This is also true in the case of unexplained persistent symptoms in levothyroxine-treated patients. Although generally considered a life-long replacement therapy, successful thyroid hormone discontinuation resulting in euthyroidism has been reported in approximately one third of patients. Thus, we overtreat patients with (subclinical) hypothyroidism, highlighting the importance of reliable diagnostic criteria. The diagnostic process, including the implementation of robust TSH and FT4 reference intervals, is especially challenging in specific situations including aging, pregnancy, non-thyroidal illness, and central hypothyroidism. There is a clear need for improved adherence to current guidelines from scientific societies and for willingness to manage symptoms without a clear pathological correlate, especially in the case of mild TSH elevations. This review will highlight recent literature on this topic and offers some practice points.

Free flap reconstruction in the lower extremity has shown success for the management of large and complex defects, restoration of function, and favorable aesthetic outcomes. Patient-reported outcomes (PROs) have not been well explored in previous literature. This meta-analysis aimed to provide a comprehensive summary of PROs after free flap reconstruction in the lower extremity. We searched MEDLINE and Embase from 1946 to 2021 for studies reporting on PROs following free flap reconstruction in the lower extremity. Overall, 53 studies were included, and 11 studies reported validated PRO measures for meta-analysis. A total of 1953 patients underwent reconstruction with 1958 free flaps for lower limb defects with a mean follow-up of 3.26 (0.25–7.83) months. The mean postoperative Lower Extremity Functional Scale (LEFS) scores were 60.3 (±12) out of 80 points (4 studies, 85 patients). The mean postoperative AOFAS scores were 75.1 (±15) out of 100 points (4 studies, 68 patients). The mean postoperative SF-36 scores were 88.1 (±8.0) out of 100 points; mental health component was 48.7 (±8.9), and physical component was 38.4 (±8.2), out of 50 points (4 studies, 88 patients). Our findings demonstrated that patients report improved physical health, mental health, and function following lower extremity reconstruction with free flaps. Patients reported similar improvements in functional scores following lower extremity reconstruction regardless of their free flap type. Furthermore, patients with myocutaneous flaps may have improved mental health and worse physical health scores when compared to perforator flaps. The evidence profiles presented in this review indicate that additional research is needed to help guide future decision-making. [ABSTRACT FROM AUTHOR]

Objectives To describe patient-reported outcomes and health-related quality of life (HRQoL) in male long-term survivors of Fournier's gangrene (FG). Methods We retrospectively identified male patients treated for FG via ICD-10 coding in two centres between January 2010 and December 2020. Patients who survived the in-house treatment were invited to participate and to complete the validated questionnaires International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF-5), Quality of Life in chronic wounds (WOUND-QoL), Freiburger Life Quality Assessment -- wound module (FLQA-w) and the Short Form Health (SF-36). Results Finally, 39 patients with a median age of 65.0 years (IQR 53.0--74.0) were identified. Twenty patients had died (51.3%), nine patients were lost to follow up (23.1%) and ten patients participated in the survey (25.6%). The median survival time was 27.0 months (IQR 9.0 -- 60.0). The median IPSS was 13.5 (IQR 4.3 - 22.3); five patients (50.0%) had severe erectile dysfunction. Three patients (30.0%) reported problems with the wound, two (20.0%) complained of wound pain and one (10.0%) about the wound-healing situation. The mean global health score on the WOUND-QoL was 1.83 (SD 1.1), which is significantly lower than in the German reference population (p<0.001). In the FLQA-w, the mean subscales were for physical aliment 1.8 (SD 1.1), everyday life 1.5 (SD 0.5), social life 1.6 (SD 0.8) and psychological well-being 1.8 (SD 1.2). The mean general health score on the SF-36 was 64.0 (SD 10.5). Conclusions In long-term survivors of FG, the wound situation has a deeply negative impact on HRQoL. [ABSTRACT FROM AUTHOR]

Abstract Purpose Endometriosis is a chronic disorder of the female reproductive system characterized by debilitating symptoms, particularly endometriosis-related pain (ERP). Patient-reported outcome (PRO) measures of symptoms and impacts are required to assess disease severity in ERP clinical studies and clinical practice. A content-valid instrument was developed by modifying the Dysmenorrhea Daily Diary (DysDD) to form the Endometriosis Daily Diary (EDD), an electronic PRO administered via handheld device. Methods Qualitative research with US females with ERP was conducted in three stages: (1) Development of an endometriosis conceptual model based on qualitative literature and conduct of concept elicitation (CE) interviews (N = 30). (2) Cognitive debriefing (CD) interviews (N = 30) conducted across two rounds to assess relevance and understanding of the EDD, with modifications between interview rounds. (3) Pilot testing to assess usability/feasibility of administrating the EDD daily on an electronic handheld device (N = 15). Clinical experts provided guidance throughout the study. Results The conceptual model provided a comprehensive summary of endometriosis to inform modifications to the DysDD, forming the EDD. CD results demonstrated that EDD items were relevant for most participants. Instructions, items, response scales, and recall period were well-understood. The resulting daily diary assesses severity of cyclic and non-cyclic pelvic pain, dyspareunia, impact of ERP on functioning and daily life, symptoms associated with ERP, and bowel symptoms. Participants were able to complete the diary daily and found the device easy to use. Conclusion The EDD demonstrated good content validity in females experiencing ERP. The next step is to perform psychometric validation in an ERP sample.

Clinical hypothyroidism is defined by the inadequate production of thyroid hormone from the thyroid gland to maintain normal organ system functions. For nearly all patients with clinical hypothyroidism, lifelong treatment with thyroid hormone replacement is required. The primary goal of treatment is to provide the appropriate daily dose of thyroid hormone to restore normal thyroid function for each individual patient. In current clinical practice, normalization of thyrotropin (TSH) level is the primary measure of effectiveness of treatment, however the use of a single biomarker to define adequate thyroid hormone replacement is being reevaluated. The assessment of clinical health outcomes and patient-reported outcomes (PROs), often within the context of intensity of treatment as defined by thyroid function tests (i.e., undertreatment, appropriate treatment, or overtreatment), may play a role in evaluating the effectiveness of treatment. The purpose of this narrative review is to summarize the prominent health outcomes literature in patients with treated hypothyroidism. To date, overall mortality, cardiovascular morbidity and mortality, bone health and cognitive function have been evaluated as endpoints in clinical outcomes studies in patients with treated hypothyroidism. More recent investigations have sought to establish the relationships between these end results and thyroid function during the treatment course. In addition to clinical event outcomes, patient-reported quality of life (QoL) has also been considered in the assessment of adequacy of hypothyroidism treatment. From a health care quality perspective, treatment of hypothyroidism should be evaluated not just on its effectiveness for the individual patients but also to the extent to which patients of different sociodemographic groups are treated equally. Ultimately, more research is needed to explore differences in health outcomes between different sociodemographic groups with hypothyroidism. Future prospective studies of treated hypothyroidism that integrate biochemical testing, PROs, and end result clinical outcomes could provide a more complete picture into the effectiveness of treatment of hypothyroidism. [ABSTRACT FROM AUTHOR]

Lung cancer is one of the most common cancers globally with high incidence and mortality rate. Acupuncture and moxibustion have been used as adjuvant therapies to relieve the symptoms and complications of lung cancer. At present, acupuncture and moxibustion can partially improve the quality of life (QOL) of cancer patients. However, the evidence that acupuncture and moxibustion can improve patient-reported outcomes (PROs) in patients with lung cancer is still insufficient. We aimed to conduct a systematic review and meta-analysis of published randomized controlled trials (RCTs) to determine whether acupuncture and moxibustion can improve PROs among patients with lung cancer, providing a support basis for acupuncture and moxibustion inclusion in relevant guidelines. We will search the following electronic databases: PubMed, Embase, Cochrane Library, Web of Science, CNKI, CQVIP, Wanfang Data, Sinomed, and gray literature including the ClinicalTrials.gov Database (clinicaltrials.gov) and Chinese Clinical Trial Register (chictr.org.cn). All English and Chinese articles will be searched until July 1, 2021. Two researchers independently extracted data. Any disagreement was resolved by discussion until consensus was reached or by consulting a third researcher. The primary outcomes mainly included the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), functional assessment of cancer therapy-lung (FACT-L), and Karnofsky Performance Status (KPS). The secondary outcomes included improvement of individual lung cancer-related symptoms and the safety of acupuncture intervention. Our study is the first to focus on the PROs of acupuncture and moxibustion for lung cancer treatment. The results will contribute to a deeper understanding of the evidence distribution of acupuncture and moxibustion in PROs, which may support the use of acupuncture and moxibustion in lung cancer patients. CRD42021274122. [ABSTRACT FROM AUTHOR]

Simple Summary: Patients' perspectives should be incorporated into the perioperative care plan in patients with bladder cancer undergoing cystectomy. Our approach incorporated both patients' perspectives and clinicians' points of view to develop and validate the MDASI-PeriOp-BLC module. The MDASI-PeriOp-BLC module was found to be a valid, reliable, and concise tool to assess symptom burden and functional recovery in this specific cohort of patients. Objectives: We developed and validated a disease-specific tool for perioperative patient-reported outcomes assessment for bladder cancer (BLC) patients undergoing radical cystectomy, The MD Anderson Symptom Inventory (the MDASI-PeriOp-BLC). Methods: Patients who underwent radical cystectomy were recruited. We used qualitative interviews and experts' input to generate disease/treatment-specific items of the MDASI-PeriOp-BLC module; conducted item reduction; examined the psychometric properties of the resultant items for reliability, validity, and clinical interpretability; and conducted cognitive debriefing interviews to assess the tool's performance. Results: A total of 150 BLC patients contributed to psychometric validation. We identified and defined eight BLC-specific module items (blood in urine, leaking urine, frequent urination, urinary urgency, burning with urination, constipation, changes in sexual function, and stomal problems). We included those 8 items in addition to 13 MDASI core symptoms and 6 interference items to form the MDASI-PeriOp-BLC module. Cronbach alphas were 0.89 and 0.90 for the 21 severity items and the 6 interference items, respectively. Test–retest reliability (intra-class correlation) was 0.92 for the 21 severity items. The MDASI-PeriOp-BLC module significantly differentiated the patients by performance status (p < 0.0001). Conclusions: The MDASI-PeriOp-BLC is a valid, reliable, and concise tool for monitoring symptom burden during perioperative care in BLC patients undergoing radical cystectomy. [ABSTRACT FROM AUTHOR]

Abstract Background Peficitinib (ASP015K), a novel oral Janus kinase inhibitor, has demonstrated efficacy and safety in the treatment of patients with rheumatoid arthritis (RA). This study evaluated the effect of peficitinib on patient- and physician-reported outcomes in Asian patients with RA and an inadequate response to prior disease-modifying antirheumatic drugs (DMARDs). Methods Patients from two randomized, placebo-controlled, double-blind, phase 3 trials (RAJ3 and RAJ4) received once-daily peficitinib 100 mg, peficitinib 150 mg, or placebo, alone or in combination with DMARDs (RAJ3), or in combination with methotrexate (RAJ4). Mean changes in Work Productivity and Activity Impairment (WPAI) questionnaire domain scores from baseline, and percentages of patients achieving minimal clinically important differences (MCIDs) for patient- and physician-reported outcomes (WPAI, Health Assessment Questionnaire – Disability Index [HAQ-DI], and Subject’s Global Assessment of Pain [SGAP]), and Physician’s Global Assessment of disease activity (PGA) were evaluated at weeks 4, 8, 12, and 12/early termination (ET). Results Data from 1025 patients were analyzed. At week 12/ET in both studies, patients who received peficitinib 100 mg or 150 mg reported significantly improved WPAI domain scores from baseline (except for absenteeism in RAJ4) compared with placebo (both doses, p

Clinical hypothyroidism is defined by the inadequate production of thyroid hormone from the thyroid gland to maintain normal organ system functions. For nearly all patients with clinical hypothyroidism, lifelong treatment with thyroid hormone replacement is required. The primary goal of treatment is to provide the appropriate daily dose of thyroid hormone to restore normal thyroid function for each individual patient. In current clinical practice, normalization of thyrotropin (TSH) level is the primary measure of effectiveness of treatment, however the use of a single biomarker to define adequate thyroid hormone replacement is being reevaluated. The assessment of clinical health outcomes and patient-reported outcomes (PROs), often within the context of intensity of treatment as defined by thyroid function tests (i.e., undertreatment, appropriate treatment, or overtreatment), may play a role in evaluating the effectiveness of treatment. The purpose of this narrative review is to summarize the prominent health outcomes literature in patients with treated hypothyroidism. To date, overall mortality, cardiovascular morbidity and mortality, bone health and cognitive function have been evaluated as endpoints in clinical outcomes studies in patients with treated hypothyroidism. More recent investigations have sought to establish the relationships between these end results and thyroid function during the treatment course. In addition to clinical event outcomes, patient-reported quality of life (QoL) has also been considered in the assessment of adequacy of hypothyroidism treatment. From a health care quality perspective, treatment of hypothyroidism should be evaluated not just on its effectiveness for the individual patients but also to the extent to which patients of different sociodemographic groups are treated equally. Ultimately, more research is needed to explore differences in health outcomes between different sociodemographic groups with hypothyroidism. Future prospective studies of treated hypothyroidism that integrate biochemical testing, PROs, and end result clinical outcomes could provide a more complete picture into the effectiveness of treatment of hypothyroidism.

Abstract Background Substantial literature has highlighted the importance of patient-reported outcome and experience measures (PROMs and PREMs, respectively) to collect clinically relevant information to better understand and address what matters to patients. The purpose of this systematic review is to synthesize the evidence about how healthcare providers implement individual-level PROMs and PREMs data into daily practice. Methods This mixed methods systematic review protocol describes the design of our synthesis of the peer-reviewed research evidence (i.e., qualitative, quantitative, and mixed methods), systematic reviews, organizational implementation projects, expert opinion, and grey literature. Keyword synonyms for “PROMs,” PREMs,” and “implementation” will be used to search eight databases (i.e., MEDLINE, CINAHL, PsycINFO, Web of Science, Embase, SPORTDiscus, Evidence-based Medicine Reviews, and ProQuest (Dissertation and Theses)) with limiters of English from 2009 onwards. Study selection criteria include implementation at the point-of-care by healthcare providers in any practice setting. Eligible studies will be critically appraised using validated tools (e.g., Joanna Briggs Institute). Guided by the review questions, data extraction and synthesis will occur simultaneously to identify biographical information and methodological characteristics as well as classify study findings related to implementation processes and strategies. As part of the narrative synthesis approach, two frameworks will be utilized: (a) Consolidated Framework for Implementation Research (CFIR) to identify influential factors of PROMs and PREMs implementation and (b) Expert Recommendations for Implementing Change (ERIC) to illicit strategies. Data management will be undertaken using NVivo 12TM. Discussion Data from PROMs and PREMs are critical to adopt a person-centered approach to healthcare. Findings from this review will guide subsequent phases of a larger project that includes interviews and a consensus-building forum with end users to create guidelines for implementing PROMs and PREMs at the point of care. Systematic review registration PROSPERO CRD42020182904 .

Introduction/Background Administration of GSK1070806, an anti–IL-18 monoclonal antibody, in patients with atopic dermatitis (AD) resulted in significant clinical improvements versus placebo after 12 weeks. Objectives Assessment of patient-reported outcomes (PROs) for patients with AD receiving GSK1070806. Methods In this multicentre, randomised, double-blind, parallel-group study (NCT04975438), adults (≥18 years) with confirmed AD diagnosis for ≥6 months and moderate-to-severe disease (Eczema Area and Severity Index ≥16; Investigator's Global Assessment score ≥3) received 2 mg/kg GSK1070806 or placebo (single one-hour intravenous infusion). PRO measures included Peak Pruritis Numerical Rating Scale (PP-NRS), Dermatology Life Quality Index (DLQI), Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS-SD 8b), Brief Fatigue Inventory Item 3 (BFI-Item 3), and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). PROs were assessed at baseline and either daily (PP-NRS and BFI-Item 3) or a combination of weekly (up to Week 4) and biweekly (after Week 4) (PROMIS-SD, DLQI and FACIT-F) for up to 24 weeks. Changes from baseline (CFB) in PP-NRS and DLQI scores at Week 12 were analysed using a Bayesian repeated measures model with all other PROs analysed descriptively. Results Of 34 enrolled patients (53% female, mean [standard deviation] age 44.8 [16.9] years), 23 received GSK1070806 and 11 received placebo. Posterior median of difference (95% credible interval) CFB at Week 12 in PP-NRS were -4.6 (-5.5, -3.7; GSK1070806) and -0.5 (-1.7, 0.7; placebo), and for DLQI were -6.1 (-8.8, -3.4; GSK1070806) and -0.01 (-4.3, 4.1; placebo). Observed mean PROMIS-SD 8b, BFI-Item 3 and FACIT-F scores also indicated improvements among patients who received GSK1070806 versus placebo. Conclusions Patients with moderate-to-severe AD who received GSK1070806 experienced positive improvements across all PROs versus placebo. These results provide further evidence of GSK1070806 benefit in patients with moderate-to-severe AD. [ABSTRACT FROM AUTHOR]

Background: Many cancer patients experience high symptom burden. Healthcare in the USA is reactive, not proactive, and doctor-patient communication is often suboptimal. As a result, symptomatic patients may suffer between clinic visits. In research settings, systematic assessment of electronic patient-reported outcomes (ePROs), coupled with clinical responses to severe symptoms, has eased this symptom burden, improved health-related quality of life, reduced acute care needs, and extended survival. Implementing ePRO-based symptom management programs in routine care is challenging. To study methods to overcome the implementation gap and improve symptom control for cancer patients, the National Cancer Institute created the Cancer-Moonshot funded Improving the Management of symPtoms during And following Cancer Treatment (IMPACT) Consortium.Methods: Symptom Management IMplementation of Patient Reported Outcomes in Oncology (SIMPRO) is one of three research centers that make up the IMPACT Consortium. SIMPRO, a multi-disciplinary team of investigators from six US health systems, seeks to develop, test, and integrate an electronic symptom management program (eSyM) for medical oncology and surgery patients into the Epic electronic health record (EHR) system and associated patient portal. eSyM supports real-time symptom tracking for patients, automated clinician alerts for severe symptoms, and specialized reports to facilitate population management. To rigorously evaluate its impact, eSyM is deployed through a pragmatic stepped wedge cluster-randomized trial. The primary study outcome is the occurrence of an emergency department treat-and-release event within 30 days of starting chemotherapy or being discharged following surgery. Secondary outcomes include hospitalization rates, chemotherapy use (time to initiation and duration of therapy), and patient quality of life and satisfaction. As a type II hybrid effectiveness-implementation study, facilitators and barriers to implementation are assessed throughout the project.Discussion: Creating and deploying eSyM requires collaboration between dozens of staff across diverse health systems, dedicated engagement of patient advocates, and robust support from Epic. This trial will evaluate eSyM in routine care settings across academic and community-based healthcare systems serving patients in rural and metropolitan locations. This trial's pragmatic design will promote generalizable results about the uptake, acceptability, and impact of an EHR-integrated, ePRO-based symptom management program.Trial Registration: ClinicalTrials.gov NCT03850912 . Registered on February 22, 2019. Last updated on November 9, 2021. [ABSTRACT FROM AUTHOR]

Abstract Background The FINE total knee was developed in Japan and clinical use began in 2001. It has unique design features, including an oblique 3o femorotibial joint line that reproduces anatomical geometry. Although 20 years have passed since the FINE knee was clinically used for the first time in Japan, a formal clinical evaluation including patient-reported and radiographic outcomes has not been undertaken. Methods A total of 175 consecutive primary cruciate-retaining (CR)-FINE total knee arthroplasties (TKAs) at our hospital between February 2015 and March 2017 were included in this study. Three years postoperatively, range of motion (ROM), Knee Society Score (KSS), Knee Injury and Osteoarthritis Outcome Score (KOOS) and Forgotten Joint Score (FJS) were recorded and compared with preoperative scores. Radiographic analyses including mechanical alignment, component alignment, and incidence of radiolucent lines also were undertaken based on the radiographs 3 years postoperatively. Results One-hundred twenty-two knees (70%) were available for 3-year follow-up data using KOOS, except for the sports subscale. Postoperative KOOS-symptom, −pain and -ADL were > 85 points, but KOOS-sports, −QOL and FJS were less satisfactory. ROM, KSS and all the subscales of KOOS were significantly improved compared with preoperative scores. Postoperative mean FJS was 66 and was significantly correlated with all the subscales of KOOS, but not with postoperative ROM. Radiolucent lines ≧1 mm wide were detected in five knees (4.1%). There were no major complications needing revision surgeries. Conclusions Patient-reported outcomes (PROs) for symptoms, pain and ADL after the CR-FINE TKA were generally improved, but those for sports, QOL and FJS were improved less. The incidence of radiolucent lines was rare but detected around the femoral components. With the mid- to long-term follow-up, improvements of surgical technique will be necessary to achieve better PROs from patients receiving the FINE knee.

A number of patient-reported outcome measure (PROM) instruments are used to assess shoulder pain, function, and postoperative satisfaction. Computer adaptive tests (CATs) have been developed in an effort to tailor question delivery, decrease time to completion and floor/ceiling effects, and increase compliance. Previous investigations have demonstrated excellent correlation between Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity CAT (UE-CAT) and American Shoulder and Elbow Surgeons (ASES) instruments, indicating that the PROMIS UE-CAT may be an acceptable alternative to the ASES. Prior to widespread adoption, however, rigorous psychometric validation must be performed. Thus, the purpose of this study was to evaluate the psychometric properties of PROMIS UE-CAT relative to the ASES score in patients undergoing primary rotator cuff repair (RCR). A retrospective study of an institutional RCR registry was performed from July 2018 through March 2019. Preoperative PROMIS UE-CAT and ASES scores were collected. Floor and ceiling effects were determined, and convergent validity was established through Pearson correlations. Rasch partial credit modeling was used for psychometric analysis of the validity of PROMIS UE-CAT and ASES question items, a previously established methodology for assessing shoulder PROMs. Person-item maps were generated to characterize the distribution of question responses along the latent dimension of shoulder disability. Responses from 107 patients (107 shoulders) were included. PROMIS UE-CAT had a strong correlation to ASES (r = 0.684; P <.001), with a 3.7% floor effect and no ceiling effect; ASES had no floor or ceiling effects. PROMIS UE-CAT person-item maps revealed excellent test item coverage between floor and ceiling effects; however, all PROMIS UE-CAT items except "Difficulty putting on a jacket" demonstrated nonsequentially ordered responses, indicating poor reliability of item responses corresponding to shoulder function. Although PROMIS UE-CAT initially demonstrated superior instrument efficiency with fewer test items for overall equivalent coverage of shoulder function assessment, final models after recursive item elimination revealed the ASES instrument to have more well-fitting items over a broader range of shoulder function. Despite its overall strong correlation with ASES and equivalent coverage between floor and ceiling effects, the psychometric properties of PROMIS UE-CAT indicate a need for optimization of individual test items to correspond to shoulder function. Until further refinements in the PROMIS UE-CAT instrument are made, it should not replace the ASES instrument in patients undergoing primary RCR. [ABSTRACT FROM AUTHOR]

Digital health tools are increasingly being used in cancer care and may include electronic patient-reported outcome (ePRO) monitoring systems. We examined physicians' perceptions of usability and clinical utility of a digital health tool (GIMEMA-ALLIANCE platform) for ePRO monitoring in the real-life practice of patients with hematologic malignancies. This tool allows for the collection and assessment of ePROs with real-time graphical presentation of results to medical staff. Based on a predefined algorithm, automated alerts are sent to medical staff. Participating hematologists completed an online survey on their experience with the platform. Of the 201 patients invited to participate between December 2020 and June 2021 (cut-off date for current analysis), 180 (90%) agreed to enter the platform and had a median age of 57 years. Twenty-three hematologists with a median age of 42 years and an average of 17 years of experience in clinical practice were surveyed. All hematologists agreed or strongly agreed that the platform was easy to use, and 87%, agreed or strongly agreed that ePROs data were useful to enhance communication with their patients. The majority of physicians (78%) accessed the platform at least once per month to consult the symptom and health status profile of their patients. The frequency of access was independent of physician sex (p =0.393) and years of experience in clinical practice (p =0.404). In conclusion, our preliminary results support the clinical utility, from the perspective of the treating hematologist, of integrating ePROs into the routine cancer care of patients with hematologic malignancies. [ABSTRACT FROM AUTHOR]

Abstract Background In oncology, detection and tracking of adverse events are of top priority and rely mostly on the Common Terminology Criteria for Adverse Events (CTCAE). Besides, clinical trials use as well patient-reported outcomes (PROs) to assess those adverse events, which are only accessible through patient self-reporting, such as fatigue, pain, and sleep disorders. Especially those issues that are not visible from the outside are often misinterpreted and underestimated by mere provider ratings. This trial aims at evaluating the impact of providing PRO data to providers on the accuracy of adverse event assessment in terms of inter-rater reliability of CTCAE ratings. Methods The trial uses a cross-sectional, unblinded, randomized controlled trial design with two trial arms and a single assessment time point. Eligible patients (aged 18 and above, any cancer diagnosis, currently under treatment, inpatient or day clinic setting, present symptom burden, no psychiatric or mental problems, written informed consent) complete an electronic version of the EORTC QLQ-C30 and 16 additional questions taken from the EORTC Item Library. PRO data is immediately processed and made available to CTCAE rating providers for conducting their ratings during the medical encounter. Patients are randomly assigned 1:1 to the intervention group (providers see PRO results on the same screen as the CTCAE rating) and the control group (no access to PRO data during the CTCAE rating). A superiority analysis will compare the inter-rater reliability (using intra-class correlation (ICC) coefficients) between the control and the intervention groups for each adverse event evaluated. Discussion The presented trial will demonstrate potential benefits of using PRO measures to improve the reliability of CTCAE ratings in cancer trials and the identification of adverse events. The new insights gained may lead to a new strategy for evaluating adverse events in clinical trials by combining patient and provider ratings. This might also have implications for daily clinical practice and cancer registries. Trial registration ClinicalTrials.gov NCT04066868 . Registered on August 26, 2019. Competence Center for Clinical Trials of the Medical University of Innsbruck 20190513-2007. Registered on May 14, 2019. (version 6.0, March 18, 2019)