1,726 results on '"Patient Reported Outcome Measures"'
Search Results
2. The impact of pulmonary embolism on health outcomes of COVID-19 at 3 months after hospitalization
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Chantal Visser, Julia C. Berentschot, Cindy M.M. de Jong, M. Louisa Antoni, L. Martine Bek, Rita J.G. van den Berg-Emons, Bram van den Borst, Hugo ten Cate, Arina J. ten Cate-Hoek, Dionne C.W. Braeken, J.J. Miranda Geelhoed, Majanka H. Heijenbrok-Kal, Sander M.J. van Kuijk, Lucia J.M. Kroft, Jenneke Leentjens, Anna H.E. Roukens, Suzanne C. Cannegieter, Frederikus A. Klok, Marieke J.H.A. Kruip, and Merel E. Hellemons
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COVID-19 ,patient reported outcome measures ,pulmonary embolism ,quality of life ,respiratory function tests ,Diseases of the blood and blood-forming organs ,RC633-647.5 - Abstract
Background: COVID-19 patients frequently experience pulmonary embolism (PE), but its long-term consequences remain uncertain. Objectives: To assess the impact of PE in COVID-19 patients on health outcomes at 3 months after hospitalization. Methods: In this multicenter cross-sectional study, we aggregated data from existing databases to evaluate the impact of PE on health outcomes at 3 months after hospitalization. We assessed 1) questionnaires on health-related quality of life (5-level EuroQol 5-dimensional questionnaire [EQ-5D-5L] questionnaire), anxiety, depression, cognitive failure, and posttraumatic stress disorder; 2) pulmonary function tests (diffusing capacity of the lungs for carbon monoxide [DLCO] and spirometry); and 3) radiological abnormalities. We developed 3 models to assess the association between PE and the EQ-5D-5L index and the percentage of predicted DLCO (DLCO%): a crude model (model 1), adjusted for age, sex, and presence of comorbidities (model 2), and model 2 additionally adjusted for intensive care unit admission (model 3). Results: We included 465 patients who had been hospitalized for COVID-19, of whom 102 (21.9%) had developed a PE during admission. Patients with PE had poorer EQ-5D-5L index values, more impairment in pulmonary functions, and more frequent radiological abnormalities than patients without PE. Symptoms of anxiety, depression, cognitive failure, and posttraumatic stress disorder did not differ between the 2 groups. In model 2, PE was associated with lower EQ-5D-5L index and lower DLCO%. After additionally adjusting for intensive care unit admission, the association between PE and lower EQ-5D-5L index (mean difference = −0.069, [95% CI, −0.12 to −0.017]) remained but not between PE and DLCO%. Conclusion: Our findings suggest that PE in COVID-19 patients is associated with reduced health-related quality of life at 3 months after hospitalization. While PE may be a marker of COVID-19 severity, its presence during hospitalization could indicate potential long-term health issues, which may be considered during follow-up care.
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- 2024
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3. Artificial intelligence in spinal deformity
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Joash Suryavanshi, David Foley, and Michael H. McCarthy
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Spinal deformity ,Artificial intelligence ,Machine learning ,Deep learning ,Neural network ,Patient reported outcome measures ,Orthopedic surgery ,RD701-811 - Abstract
Objective: To facilitate discussion surrounding the use of AI in medicine so that it may lead to improved surgeon and patient outcomes in the future. Background: Artificial intelligence (AI) refers to algorithms that utilize data to mimic human cognition. Machine learning (ML) is a subset of AI that enables the algorithm to improve without explicit human direction. Methods: Narrative overview of the literature synthesized from searches of computerized databases and authoritative texts. Discussion: There are forms of ML in use both in research and clinical settings today, which can personalize medical care in the future. In spine surgery, AI can affect care in the following domains: pre-operative workup, surgical planning, and outcome prediction. The use of AI in adult spinal deformity (ASD) poses unique opportunities for growth, as outcomes after ASD are often difficult to predict due to disease complexity. Recently, the use of AI modeling has gained traction with large multi-institutional organizations, leading to robust publications aided by an abundance of prospectively collected data. However, current AI usage still has concerns that should not be taken lightly. Conclusion: In the following review, we outline the basis of AI, its current clinical uses and potential benefits, and its various challenges.
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- 2025
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4. Bridging the care gap: patients’ needs and experiences regarding shared decision-making in radiotherapy
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A.R. van Hienen, C.J.W. Offermann, L.J. Boersma, M.J.G. Jacobs, and R.R.R. Fijten
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Shared Decision Making ,Patient Preference ,Physicians ,Neoplasms ,Educational Status ,Patient Reported Outcome Measures ,Medical physics. Medical radiology. Nuclear medicine ,R895-920 ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Background and purpose: Shared decision-making (SDM), a collaborative process in which patients and physicians jointly determine further treatment, has been associated with numerous positive effects. However, its implementation into routine clinical practice faces challenges. In radiotherapy (RT) it may have additional challenges, since patients are referred from another oncologist, often “to undergo RT”. The aim of this study is to understand patients’ preferences and experiences regarding SDM at an academic RT clinic, and to identify targets for SDM implementation in RT. Materials and methods: We adapted an earlier survey sent out by the Dutch Cancer Patient Organizations Federation to fit the RT setting. The survey was distributed via letters and social media to (former) patients who had their intake between 2020 and 2022. Results: 1799 participants completed the survey, of whom 88,3% mentioned to always or often prefer SDM. 23,1% of participants reported experiencing a choice, and 50% of these participants experienced multiple options. The most commons reason for preferring SDM was bodily autonomy (n = 1114) and against SDM was wanting to decide themselves instead (n = 11). Participants with a higher educational attainment were more likely to prefer and experience SDM. Older participants were more likely to experience multiple options. Conclusion: Our findings reaffirm that most cancer patients prefer SDM, and extend these findings to RT. However, we found a large gap between patients’ desire for SDM, and the SDM experienced in our RT institute. SDM implementation strategies are needed and should focus on overcoming RT-specific and patient-reported barriers and opportunities.
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- 2025
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5. Expanding the ABCC-tool for osteoarthritis: Development and content validation
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V.H.J. Debie, T.A.E.J. Boymans, R.P.G. Ottenheijm, O.C.P. van Schayck, and A.H.M. Gidding-Slok
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Osteoarthritis ,ABCC-tool ,Burden of disease ,Patient-centered care ,Patient reported outcome measures ,Shared-decision making ,Diseases of the musculoskeletal system ,RC925-935 - Abstract
Objective: Osteoarthritis (OA) care should be more person-centered based on physical, emotional and social aspects, instead of the current stepped-care approach solely based on physical symptoms, according to OA patients. By developing a novel module for OA in the Assessment of Burden of Chronic Condition (ABCC)-tool, a tool based on these three aspects, experienced quality of OA care and shared-decision making are expected to improve. Design: The development of the novel OA module involved a triangular iterative process, interviewing OA patients and healthcare professionals in the field of OA, an expert panel and a literature search to identify the needs to improve OA care. Patients provided feedback on the first version of the OA module, leading to a second version. This second version was used to evaluate content validity. OA patients and healthcare professionals in the field of OA were asked to evaluate relevance, comprehensiveness and comprehensibility, based on the COSMIN methodology. For healthcare professionals, the item-content validity index (I-CVI) was calculated. Results: The module includes questions about pain, kinesiophobia and joint stiffness. For all three questions, 94% of the patients found these questions important for patients with OA. The I-CVI scores of the healthcare professionals ranged from 1.0 (pain, kinesiophobia) to 0.75 (joint stiffness). Conclusion: A novel, condition-specific OA module is developed for the ABCC-tool, as a supplement to the generic questions. The module includes three questions, to measure OA specific complaints. This novel module is intended to make the ABCC-tool more elaborate and useable for a larger population.
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- 2024
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6. Assessment of quality of life among breast cancer patients undergoing different Treatment Modalities at tertiary hospitals in north Karnataka, India
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Fatima Khazi, Mubashir Angolkar, Sai Kumari, and B.R. Patil
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Breast carcinoma ,Quality of life ,Patient reported outcome measures ,Public aspects of medicine ,RA1-1270 - Abstract
Introduction: Breast cancer treatment is an aggressive therapy that affects the patient's quality of life (QoL). This study aims to assess the impact of breast cancer treatment on the QoL of breast cancer patients undergoing treatment. Methods: This cross-sectional study was conducted among breast cancer patients attending two tertiary care hospitals between August 2021 to December 2022. QoL of female patients above 18 years of age with a histopathological confirmation of Stage I-III breast cancer and an ECOG Performance Status between 0 and 1 was assessed using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ C30) and Breast Cancer Specific Quality of Life Questionnaire (QLQ BR 23). Kruskal -Wallis and Mann Whitney U tests were used to assess the impact of treatment on QoL of breast cancer patients. Linear regression was used to identify predictors of QoL. Results: A total of 428 respondents with a mean age of 48.67 years participated in the study. Mean score for Global Health Status was 59.87. High mean scores for functional scales were observed in cognitive functioning (79.17), followed by role functioning (72.04) and physical functioning (71.45). Among the symptom scales, high scores were noted for financial difficulty (67.60) followed by hair loss (54.52). QoL score of patients who underwent surgery was high (54.93) as compared to patients undergoing radiation (49.37) and chemotherapy (44.96). Conclusion: The overall QoL of women with breast cancer undergoing treatment was good. QoL of patients undergoing chemotherapy was the lowest, while patients who underwent surgery exhibited a better QoL.
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- 2024
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7. Midterm outcomes of primary reverse shoulder arthroplasty: a systematic review of studies with minimum 5-year follow-up
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Tom R. Doyle, Mb, BCh, Sophia Downey, Eoghan T. Hurley, MCh, PhD, Christopher Klifto, MD, Hannan Mullett, MCh, FRCS, Patrick J. Denard, MD, Grant E. Garrigues, MD, and Mariano E. Menendez, MD
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Shoulder arthroplasty ,Reverse shoulder arthroplasty ,Systematic review ,Rotator cuff arthropathy ,Irreparable rotator cuff tear ,Patient reported outcome measures ,Surgery ,RD1-811 - Abstract
Background: Excellent short-term outcomes after reverse shoulder arthroplasty (RSA) have been reported, but longer term outcomes in the existing literature are sparse and vary widely. The purpose of this study is to systematically assess the existing literature to quantify functional outcomes and complication rates after RSA at a minimum of five years of follow-up. Methods: A Preferred Reporting Items for Systematic Reviews and Meta-analyses-compliant systematic literature search of the PubMed and Embase databases was undertaken. Studies reporting outcomes after primary RSA for nontrauma-related indications with a minimum of 5-year follow-up were included. Results: Overall, 20 studies satisfied all inclusion criteria. This represented 1591 shoulders in 1556 patients (32.1% males), with a mean age of 70.2 ± 5.0 years and mean follow-up of 8.8 years, or 106.2 ± 30.1 months (60-243). At final follow-up, the mean reported Constant Murley score was 62.1 ± 5.0 (49.0-83.0). The mean adjusted Constant Murley score was 83.5 ± 12.5 (58-111.9). The mean American Shoulder and Elbow Surgeons score was 81.8 ± 4.6, while the mean subjective shoulder value was 74.6 ± 6.4. Overall, 88% of patients rated their satisfaction as either good or very good. The range of active forward flexion, abduction, external, and internal rotation were respectively, 126° ± 13°, 106° ± 11°, 22° ± 11°, and 6° ± 2°. The overall rate of revision surgery was 4.9% (0%-45.5%). Regarding complications, the rate of prosthetic joint infection was 4.3% (0%-26.7%), shoulder dislocation was 3.7% (0%-20.4%), and acromial fracture was 2.0% (0%-8.8%). At final follow-up, 30.9% of shoulders had some degree of scapular notching. Conclusion: This systematic review shows that RSA results in high satisfaction rates, good clinical outcomes, as well as modest complication and revision rates at minimum 5-year follow-up.
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- 2024
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8. Trends in shoulder surgery patient-reported outcome measures
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Rajpal Narulla, MBBS, MS, Mark Song, MBBS, MS, Sascha Karunaratne, BHlthSci(Hon)/MPhty, Christopher Smithers, MBBS, FRACS, FAOrthA, and Jeffrey Petchell, MBBS, MMed (Clin Epi), FRACS, FAOrthA
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PROMs ,Shoulder surgery ,Arthroplasty ,Instability ,Rotator cuff ,Patient reported outcome measures ,Orthopedic surgery ,RD701-811 ,Diseases of the musculoskeletal system ,RC925-935 - Abstract
Patient-reported outcome measures (PROMs) are a vital part of the toolkit for the current practice of orthopedic surgery. We are witnessing the expansion of the use of PROMs in clinical practice and in research; the ultimate direction of this expansion is unclear. The purpose of this systematic review was to identify the trends in the use of PROMs in major upper limb publications over a 7-year period. We retrospectively reviewed all articles published in 6 of the most influential upper limb orthopedic journals based on impact factor from January 2013 to January 2020. PubMed, Medline, and Embase were used to access the abstracts for all articles published for this period. We included all articles related to shoulder arthroplasty, shoulder instability, rotator cuff surgery, and involving the use of PROMs. There were 4175 articles identified from the selected journals over the chosen time period, of which 607 were eligible for inclusion in the study. The number of articles reporting PROMs increased from 57 in 2013 to 115 in 2019, which was a 102% increase. The total number of PROM usages recorded was 1593 which was comprised of 63 different scoring systems, with each article using a median of 3 different PROMs. The most commonly used score in articles originating from North America was the American Shoulder and Elbow Surgeons score (216 uses in 273 articles; 78.1%), from Europe it was the Constant-Murley Score (129 uses in 183 articles; 70.4%), and from Asia it was the American Shoulder and Elbow Surgeons score (80 uses in 126 articles; 63.4%). The use of PROMs is evolving with an increasing prevalence of and diversity of PROMs being used in upper limb surgery. There is geographical variation in the use of PROMs, and a variety of systems used, with only 3 of the top 10 most used PROMs reporting on patient satisfaction or wellbeing. Given that a diverse range of PROMs study a diverse range of conditions and procedures, there may not be a need for a consensus on the best overall use of PROMs, but there may be ideal PROMs suited to answer specific questions.
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- 2023
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9. Association of long COVID with health-related Quality of Life and Social Participation in Germany: Finding from an online-based cross-sectional survey
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Dominik Schröder, Stephanie Heinemann, Gloria Heesen, Eva Hummers, Tim Schmachtenberg, Alexandra Dopfer-Jablonka, Kai Vahldiek, Frank Klawonn, Sandra Klawitter, Sandra Steffens, Marie Mikuteit, Jacqueline Niewolik, and Frank Müller
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Post-acute COVID-19 syndrome ,COVID-19 ,Quality of life ,Patient reported outcome measures ,Social participation ,Science (General) ,Q1-390 ,Social sciences (General) ,H1-99 - Abstract
Purpose: This study aims to examine the health-related Quality of Life (hrQoL) and social participation in participants with Long COVID compared to participants without symptoms after COVID-19 and participants with no prior SARS-CoV-2 infection. Methods: A cross-sectional online survey was conducted in Germany. The non-random sample consists of participants 18 years or older. Participants were divided in three groups: Lg COVID with a prior SARS-CoV-2 infection and new or persistent symptoms 28 days after infection, ExCOVID with a prior SARS-CoV-2 infection and without new or persistent symptoms after 28 days, and NoCOVID when participants had no prior SARS-CoV-2 infection. EQ-5D-3L was used as hrQoL measure and the Index for the Assessment of Health Impairments (IMET) to reflect social participation. Descriptive and inferential statistics were performed. Results: A total of 3188 participants were included in the analysis (1421 Lg COVID, 260 ExCOVID, 1507 NoCOVID). Lg COVID was associated with the lowest EQ-5D-3L index values (p
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- 2024
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10. Patient Reported Outcome Assessments Used in the Evaluation of Patients after Ileal Pouch-Anal Anastomosis: A Systematic Review
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Edward L. Barnes, Marcella H. Boynton, Darren A. DeWalt, Hans H. Herfarth, and Michael D. Kappelman
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Patient Reported Outcome Measures ,Pouchitis ,J-Pouch ,Quality of Life ,Diseases of the digestive system. Gastroenterology ,RC799-869 - Abstract
Background and Aims: There is a paucity of validated measures to evaluate how patients feel and function after restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) for ulcerative colitis. We performed a systematic review to evaluate all published patient reported outcomes (PROs) to assess symptom burden, functional status, and quality of life (QoL) after IPAA. Methods: An electronic literature search on PubMed, Embase, and Web of Science was performed from inception through October 12, 2021. Eligible full texts were further characterized by the type of assessment as well as the individual domains assessed by questions in the PRO measure. Results: Among the 129 full texts analyzed, 51 specific PRO measures were utilized. In the evaluation of all PRO measures, 46% included an assessment of disease-specific QoL with 27% evaluating more general QoL, and 15% assessing symptoms related to pouch function. Among the studies using disease-specific instruments, the Cleveland Clinic Global Quality of Life (42%) and the Inflammatory Bowel Disease Questionnaire (21%) were the most commonly used PRO measures. PRO questions were mapped to individual domains using binning methodology, with the greatest number of questions from individual PRO measures mapped to the bowel function domain (122). Conclusion: In our assessment of PRO measures among patients after IPAA, the studies and individual measures varied widely in both the patient populations being evaluated as well as outcomes and specific domains being assessed. A valid measure that assesses the range of outcomes after IPAA could standardize assessment and advance the study of patients after IPAA.
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- 2023
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11. Developing Core Outcome Sets for Vascular Conditions Across Europe, Not as Easy as It Sounds
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Matthew Machin and Janet T. Powell
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Clinical trial ,Core outcome set ,Patient reported outcome measures ,Vascular surgery ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 ,Surgery ,RD1-811 - Abstract
Introduction: Most of the outcomes reported in the literature have been chosen by doctors, constituting “traditional” outcome measures such as mortality and re-intervention. Some of the key outcome measures important to patients, families, health providers and other stakeholders may have been overlooked. Core outcome sets, consisting of 6–15 outcomes, can improve representation of all key stakeholders, standardise outcome reporting, and improve future ability to pool results. The aim of this study was to outline the methods and challenges of conducting European core outcome sets. Report: As an overview, development of core outcome sets follows a multistep iterative process: (1) Systematic review of the literature summarising existing outcome measures, (2) Focus Group meeting with patients and other stakeholders to establish missing outcome measures, (3) Development and piloting of Delphi survey, (4) Delphi consensus study for prioritisation of outcomes and establishing consensus, and (5) European consensus meeting to produce a core outcome set. The challenges include the varying ethical requirements for survey work across Europe and translation for surveys and consensus meetings. Discussion: There is an increasing need for core outcome sets to complement clinical practice guidelines. As a European vascular community we need to produce these through collaborative efforts. Unfortunately, there are considerable barriers to doing so – the time and energy required to set up a core outcome study is not dissimilar to that of a multicentre randomised trial. Currently only one core outcome set exists for vascular surgery, for critical limb ischaemia, but this was developed in a single country.
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- 2023
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12. Results of single-incision distal biceps tendon repair for early-career upper-extremity surgeons
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Jessica L. Baylor, BS, Daniel J. Torino, MD, Idorenyin F. Udoeyo, MPH, C. Liam Dwyer, MD, and Louis C. Grandizio, DO
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Distal biceps rupture ,Distal biceps repair ,Elbow surgery ,Surgical complications ,Patient reported outcome measures ,Surgical learning curve ,Orthopedic surgery ,RD701-811 ,Diseases of the musculoskeletal system ,RC925-935 - Abstract
Background: The purpose of this investigation was to assess surgical outcomes after distal biceps tendon (DBT) repair for upper-extremity surgeons at the beginning of their careers, immediately following fellowship training. We aimed to determine if procedure times, complication rates, and clinical outcomes differed during the learning curve period for these early-career surgeons. Methods: All cases of DBT repairs performed by 2 fellowship-trained surgeons from the start of their careers were included. Demographic data as well as operative times, complication rates, and patient reported outcomes were retrospectively collected. A cumulative sum chart (CUSUM) analysis was performed for the learning curve for both operative times and complication rate. This analysis continuously compares performance of an outcome to a predefined target level. Results: A total of 78 DBT repairs performed by the two surgeons were included. In the CUSUM analysis of operative time for surgeon 1 and 2, both demonstrated a learning curve until case 4. In CUSUM analysis for complication rates, neither surgeon 1 nor surgeon 2 performed significantly worse than the target value and learning curve ranged from 14 to 21 cases. Mean Disabilities of Arm, Shoulder, and Hand score (QuickDASH) (10.65 ± 5.81) and the pain visual analog scale scores (1.13 ± 2.04) were comparable to previously reported literature. Conclusions: These data suggest that a learning curve between 4 and 20 cases exists with respect to operative times and complication rates for DBT repairs for fellowship-trained upper-extremity surgeons at the start of clinical practice. Early-career surgeons appear to have acceptable clinical results and complications relative to previously published series irrespective of their learning stage.
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- 2023
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13. Psychometric Evaluation of the Korean Version of PROMIS Self-Efficacy for Managing Symptoms Item Bank: Item Response Theory
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Mona Choi, Chang Gi Park, and Soomin Hong
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Patient reported outcome measures ,psychometrics ,self-efficacy ,validity study ,Nursing ,RT1-120 - Abstract
Summary: Purpose: To evaluate the psychometric properties of the Patient-Reported Outcomes Measurement Information System (PROMIS) self-efficacy for managing symptoms of the version 1.0 item bank in Korea. Methods: This study consisted of two phases: first, developing the Korean version of the item bank following the translation guidelines; and second, performing a cross-sectional study to evaluate its psychometric properties using the item response theory. This study enrolled 323 patients with type 2 diabetes mellitus between July and August 2020. Cronbach's α was used to assess the reliability of this item bank. Confirmatory factor analysis, using diagonally weighted least squares, was used to identify the assumptions of item response theory. Item parameter estimates including discrimination and thresholds were derived using the graded response model of the item response theory to reflect patient-reported outcomes as individualized responses. Results: The Korean version of the item bank demonstrated good reliability (Cronbach's α = .98) and its discrimination ranged from 1.82 to 4.93. The thresholds resulted in the establishment of a category response curve for each item. However, no overlap was observed among the category curves. Moreover, the differential item functioning was not significant for age, gender, and income variables. Conclusion: The graded response model and differential item functioning provided qualitative evidence that demonstrated acceptable psychometric properties of symptom management self-efficacy among patients. This item bank is expected to provide adequate assessments of self-efficacy of symptom management for patients with a chronic disease, which can contribute to nursing research and intervention.
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- 2022
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14. The impact of the COVID-19 pandemic on health-related quality of life in head and neck cancer survivors: An observational cohort studs
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B.I. Lissenberg-Witte, F. Jansen, R.J. Baatenburg de Jong, F. Lamers, C.R. Leemans, S.F. Oosting, R.P. Takes, and I.M. Verdonck-de Leeuw
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Head and neck cancer ,Survivors ,COVID-19 ,Health-related quality of life ,Patient reported outcome measures ,Prospective cohort ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Objective: To investigate the impact of the COVID-19 pandemic on physical, psychological, and social aspects of health-related quality of life (HRQOL) among head and neck cancer (HNC) survivors. Materials and methods: Prospectively collected data from the NETherlands QUality of life and BIomedical Cohort study in HNC were used. All patients were diagnosed and treated before the COVID-19 pandemic. Patient reported outcome measures (PROMs) collected 24 and 36 months after treatment (M24 and M36) were compared between survivors who completed both assessments before the COVID-19 pandemic and those who completed M24 before but M36 during the pandemic. Personal, clinical, physical, psychological, social, and lifestyle characteristics of the survivors assessed at baseline or M24 were investigated as potential effect modifiers. Results: In total, 318 HNC survivors were included, of which 199 completed both M24 and M36 before the COVID-19 pandemic and 119 completed M24 before but M36 during the pandemic. Changes in HRQOL between 24 and 36 months follow-up did not differ between the two groups for any of the PROMs. Nevertheless, in some subgroups of HNC survivors the COVID-19 pandemic negatively affected the course of HRQOL for several PROMs while it positively affected the course of HRQOL for other PROMs. Conclusions: The COVID-19 pandemic did not affect HRQOL in HNC survivors in general, but some subgroups were affected in a positive and others in a negative way.
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- 2023
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15. The cost of elective nodal coverage in prostate cancer: Late quality of life outcomes and dosimetric analysis with 0, 45 or 54 Gy to the pelvis
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Garrett L. Jensen, Sameer G. Jhavar, Chul S Ha, Kendall P. Hammonds, and Gregory P. Swanson
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Elective nodal radiation ,Patient reported outcome measures ,Quality of life ,Medical physics. Medical radiology. Nuclear medicine ,R895-920 ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Purpose: Elective pelvic lymph node radiotherapy (PLNRT) in prostate cancer is often omitted from definitive (n = 267) and post prostatectomy (n = 160) radiotherapy (RT) due to concerns regarding toxicity and efficacy. Data comparing patient-reported outcome measures (PROMs) with or without PLNRT is limited. Our long-term supposition is that PLNRT, particularly to higher doses afforded by IMRT, will decrease pelvic failure rate in select patients. We aim to establish the impact of two different PLNRT doses on long term quality of life (QOL). Methods and materials: Prostate cancer patients (n = 428) recorded baseline scores using the Expanded Prostate Cancer Index Composite (EPIC), prior to definitive or post-prostatectomy RT. PLNRT, if given, was prescribed to 45 or 54 Gy at 1.8 Gy per fraction. New EPIC scores were recorded 20–36 months after radiotherapy. Absolute change in each domain subscale and summary score was recorded, along with if these changes met minimally important difference (MID) criteria. A separate multivariate analysis (MVA) was performed for each measure. Subsequent dosimetric analysis was performed. Results: Frequency of a MID decline was significantly greater with PLNRT to 54 Gy for urinary function, incontinence, and overall. No urinary decline was correlated with PLNRT to 45 Gy. PLNRT to 54 Gy was significant for decline in urinary function, bother, irritative, incontinence, and overall score in one or both MVA models while 45 Gy was not. Postoperative status was significant for decline in urinary function, incontinence, and overall. Amongst postoperative patients, there was significantly greater decline in urinary function score in the salvage setting. Neither 54 nor 45 Gy significantly affected bowel subscale or overall score decline. Conclusions: Using conventional fractionation, adding PLNRT to 54 Gy, but not 45 Gy, correlates with worse urinary QOL, with postoperative patients experiencing a steeper decline. PLNRT had no significant impact on bowel QOL with either dose.
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- 2022
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16. A narrative review of recent literature of the quality of life in hereditary angioedema patients
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Herberto José Chong-Neto
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Angioedema ,Hereditary ,Health-related quality of life ,Patient reported outcome measures ,Questionnaire ,Preventive therapy ,Immunologic diseases. Allergy ,RC581-607 - Abstract
Hereditary angioedema (HAE) is a rare disorder that causes unpredictable and debilitating cutaneous and submucosal edema and can lead to death. HAE can impair patients' ability to perform daily activities, proportional to pain severity, with patients reporting lower productivity, missed time from work or school and potentially resulting in missed career and educational opportunities. Many patients with HAE experience a significant psychological burden, including anxiety and depression. Available treatment aims to prevent and/or treat HAE attacks as they occur, to reduce morbidity and mortality and, finally, to improve health-related quality of life. Two different validated specific angioedema instruments are available to assess patients' quality of life. The Angioedema Quality of Life Questionnaire (AE-QoL) examines diagnosed patients' quality of life but is not specific for HAE. The disease-specific questionnaire is the Hereditary Angioedema Quality of Life (HAE-QoL), and the first used for hereditary angioedema with C1 inhibitors (C1-INH) deficiency. These quality-of-life instruments are helpful to the HAE patients' assessment and to the development of better therapeutic strategies as clinical tools, as defined by international guidelines. Considering this context, this review was conducted to compare the effects of acute vs. long-term prophylaxis on HAE patients’ health-related quality of life. In addition, the prevalence of anxiety and depression among these individuals was also reviewed.
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- 2023
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17. On the sensitivity of PROMs during breast radiotherapy
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Gerd Heilemann, Andreas Renner, Daniela Kauer-Dorner, Stefan Konrad, Inga-Malin Simek, Dietmar Georg, and Joachim Widder
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Patient reported outcome measures ,Breast cancer ,Quality of life ,Partial breast ,Irradiation ,eHealth ,Medical physics. Medical radiology. Nuclear medicine ,R895-920 ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Purpose: To investigate the sensitivity of patient-reported outcome measures (PROMs) to detect treatment-related side effects in patients with breast cancer undergoing external beam photon radiotherapy. Methods: As part of daily clinical care, an in-house developed PROM tool was used to assess side effects in patients during a) whole-breast irradiation (WBI) to 40 Gy, b) WBI with a sequential boost of 10 Gy, and c) partial-breast irradiation (PBI) to 40 Gy. Results: 414 patients participated in this prospective study between October 2020 and January 2022, with 128 patients (31 %) receiving WBI, 241 (58 %) receiving WBI followed by a sequential boost, and 50 patients (12 %) receiving PBI. Significant differences in the reported toxicities (itching, radiation skin reaction, skin darkening, and tenderness and swelling) were reported between the WBI cohorts with and without boost (p
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- 2023
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18. Frequency and burden of potentially treatable symptoms in glioma patients with stable disease
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Jantine G. Röttgering, Vera Belgers, Mathilde C.M. Kouwenhoven, Maaike Schuur, Tjeerd J. Postma, Claudia M. Nijboer, Myra E. van Linde, Philip C. de Witt Hamer, Linda Douw, and Martin Klein
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Psychosocial intervention ,Patient reported outcome measures ,Fatigue ,Brain neoplasms ,Quality of life ,Depression ,Science (General) ,Q1-390 ,Social sciences (General) ,H1-99 - Abstract
Background & aims: Glioma patients experience a multitude of symptoms that negatively affect their health-related quality of life. Symptoms vary greatly across disease phases, and the patients' stable phase might be particularly suitable for assessing and treating symptoms. Identifying symptoms and patients' needs is a first step toward improving patient care. In glioma patients with stable disease, we assessed the frequency and burden of patient-reported symptoms, examined how these symptoms co-occur, and also determined whether patients would consider treatment to ameliorate specific symptoms. Methods: In this retrospective study, patients rated the frequency and burden of seventeen symptoms on a seven-point Likert scale and stated whether they would consider treatment for these symptoms. Correlations between frequency, burden, and considering treatment were evaluated with Kendall’s Tau correlation coefficients. Based on partial correlations between symptom frequencies we visualized the symptoms as a network. Results: Fifty-two glioma patients with stable disease were included (31 WHO grade II/III, 21 WHO grade IV). The top five symptoms were fatigue, memory problems, reduced physical fitness, concentration problems, and drowsiness. Fatigue had the highest median frequency (4.5, interquartile range 2.5). Over half of the patients experienced three or more symptoms simultaneously and associations between all symptoms were depicted as a network. Overall, 35% of patients would consider treatment for at least one symptom. The wish to undergo symptom treatment correlated only moderately with symptom frequency and burden (range of correlations 0.24–0.57 and 0.28–0.61, respectively). Conclusion: Glioma patients with stable disease experience multiple symptoms with a consequently high symptom burden. Despite the high prevalence of symptoms, the inclination for symptom management interventions was relatively low. The most frequent and burdensome symptoms and the way they are interrelated could serve as a roadmap for future research on symptom management in these patients.
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- 2023
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19. Associations between postural orientation errors in patients undergoing rehabilitation for ACL reconstruction and future patient-reported outcomes: An explorative study
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Anna Cronström, Eva Ageberg, Erika Zeraidi, Julia Larsson, and Jenny Nae
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Anterior cruciate ligament ,Knee injuries ,Postural orientation ,Patient reported outcome measures ,Sports ,GV557-1198.995 ,Sports medicine ,RC1200-1245 - Abstract
Objective: To investigate associations between postural orientation errors (POEs) in patients undergoing rehabilitation for anterior cruciate ligament reconstruction (ACLR) and patient-reported outcomes (PROMs) at 2-year follow-up. Design: Prospective cohort study. Methods: Fifty-three participants (mean (SD) 27 (6.5) years, 24 women), (mean (range) 7 (4–10) months post ACLR) were included. At baseline, all participants were visually assessed for POEs using a validated test battery. The POE subscales Activities of Daily Living and Sport were used in the analysis. At 2-years, the following PROMs were collected: Global knee function, Knee injury and Osteoarthritis Outcome Score, ACL Quality of Life (QoL), Knee Self-Efficacy Scale (K-SES), and ACL Return-to-Sport after Injury scale. Results: Twenty-one participants answered the questionnaires at 2 years (7 women and 14 men). Worse baseline POE Sport was associated with worse scores on K-SES (rs = –0.435, p ≤ 0.049) and ACL-QoL (rs = −0.467 to −0.576, p ≤ 0.038) at follow-up. No statistically significant associations were observed between POEs and the other PROMs. Conclusion: Postural orientation during the rehabilitation phase may be important for future knee self-efficacy and knee-related QoL after ACLR. Given the small population and low response rate, this result needs to be confirmed in future research.
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- 2023
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20. Financial hardship is associated with employment challenges and reduced quality of life in early Parkinson’s disease
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Miriam R. Rafferty, Sydney Achler, Han Su, Masha Kocherginsky, Danny Bega, Allen W. Heinemann, and Kurt Johnson
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Parkinson’s disease ,Employment ,Disability ,Patient reported outcome measures ,Financial toxicity ,Neurology. Diseases of the nervous system ,RC346-429 - Abstract
Introduction: Motor and nonmotor Parkinson’s disease (PD) symptoms can negatively influence employment, which may contribute to financial hardship. This article explores the association between financial hardship, employment challenges, and quality of life in people with early PD. Methods: We measured financial hardship with a validated summary item (5-point scale, lower score - less hardship) and the Comprehensive Score for Financial Toxicity (0–44, lower score worse toxicity) in a cohort of 60 employed individuals with early PD (
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- 2023
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21. Health related outcomes of patients with serious traumatic injury: Results of a longitudinal follow-up program delivered by trauma clinicians.
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Dale K, Winkleman C, Hughes I, Heathcote K, and Wake E
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- Humans, Male, Female, Adult, Prospective Studies, Middle Aged, Follow-Up Studies, Longitudinal Studies, Outcome Assessment, Health Care, Depression, Anxiety, Disability Evaluation, Quality of Life, Trauma Centers, Wounds and Injuries therapy
- Abstract
Introduction: The routine collection of long-term patient health outcomes after serious traumatic injury at the health service level is uncommon. In 2019, we implemented the longitudinal Trauma Service Follow Up (TSFU) program at a level I trauma centre. Delivered by the trauma service clinicians involved in inpatient care, it assesses quality of life and disability. This study reports the 6- and 12-month outcomes of the first two years of operation of the TSFU program., Methods: This is a prospective cohort study of seriously injured adult trauma patients admitted to a level I trauma centre with 6- and 12-months post-discharge outcome assessments. Outcomes were quality of life and function/disability as measured using the EQ-5D-5L and WHODAS 2.0 validated instruments. Changes from 6 to 12 months were assessed using generalised estimating equations methods. Logistic regression models were used to identify factors associated with ongoing problems at each time point., Results: Five-hundred and eight seriously injured patients were eligible for the TSFU program with follow-up rates over 80 % at both 6- and 12-month timepoints. At six months, ongoing problems with pain (69.9 %), anxiety and depression (49 %) and carrying out usual activities (57.5 %) were highly prevalent; at 12 months problems with pain (61.4 %) and anxiety and depression (43.8 %) persisted. Lower extremity and/or pelvic surgery was associated with ongoing pain, odds ratio (OR) = 3.77 (95 % CI 1.54-9.21, p=0.01), anxiety and depression (OR 1.95, 95 % CI 1.09-3.48, p=0.02) and problems carrying out their usual activities (OR 3.19, 95 % CI 0.75-13.5, p=0.11) at six months. These patterns mostly persisted at 12 months. Similar associations between surgical intervention and high levels of disability were evident at both time points., Conclusion: Persistent impairments in physical and emotional health continues to affect many people following serious traumatic injury. The collection of longitudinal health outcomes by trauma clinicians enables identification of factors that contribute to disability and a reduction in quality of life. This in turn can drive quality improvement initiatives within the hospital trauma system. Longitudinal follow-up programs may provide a platform to provide ongoing specialist trauma-informed care after hospital discharge., Competing Interests: Declaration of competing interest The authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved.)
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- 2024
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22. An early analysis of polyetheretherketone (PEEK) plates for the surgical stabilization of rib fractures: A pilot study.
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Bauman ZM, Tian Y, Puthoff G, Whitbeck SA, Gardner S, and White TW
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- Humans, Pilot Projects, Male, Female, Prospective Studies, Middle Aged, Treatment Outcome, Aged, Adult, Quality of Life, Biocompatible Materials, Tomography, X-Ray Computed, Rib Fractures surgery, Benzophenones, Ketones, Polymers, Polyethylene Glycols therapeutic use, Bone Plates, Fracture Healing, Fracture Fixation, Internal methods, Fracture Fixation, Internal instrumentation
- Abstract
Background: Surgical stabilization of rib fractures (SSRF) is a viable treatment option for rib fracture patients. Polyetheretherketone (PEEK) plates have become available for SSRF. The objective of this pilot study was to examine the use of PEEK plates for SSRF., Methods: A prospective, observational, multi-center study of patients undergoing SSRF with PEEK plates from 4/23 through 2/24. Standard indications for SSRF were followed and the decision to use PEEK plates was left to the discretion of the treating surgeon. Basic demographics were obtained. Outcomes included the number of rib fractures stabilized with PEEK plates, complications related to SSRF, and 6-month follow-up with chest computed tomography (CT) to assess healing of PEEK repaired fracture sites, identified as complete or incomplete union. Patients also answered a five-question quality-of-life survey regarding mobility, self-care, usual activities, chest pain/discomfort, and anxiety/depression. Answers were scaled 1 to 5 (1=worse condition possible; 5=best possible condition). Patients rated their health on a scale of 0 to 100 (100=closet to their health preinjury). All data was reported as descriptive., Results: Forty-six patients were included. Average age was 57(±16) years; 82.6 % were male. Median ISS was 18 (IQR 14,29) and median chest-AIS was 4 (IQR 3,4). 219 rib fractures were stabilized with PEEK plates. Sixteen (34.8 %) had a combination (PEEK + titanium) procedure. Three patients had a complication: one required a second surgery for additional SSRF, and two patients were readmitted. Twenty-seven patients were surveyed at 6 months, and 19 agreed to CT scan. Eighty PEEK repaired rib fractures were assessed for healing. 80 % of fractures had complete union and no hardware failure. Quality-of-life survey averaged >4.5/category and mean overall health was 89., Conclusion: PEEK plates for SSRF are safe and effective, allowing for adequate rib fracture healing and are associated with positive patient reported outcomes., Competing Interests: Declaration of competing interest Dr. Zachary Bauman is a paid educational consultant for KLS-Martin, Zimmer-Biomet, Atricure, and Smith&Nephew. Dr. Thomas White is a paid educational consultant for DePuy Synthes and KLS-Martin. No other authors have any conflicts of interest., (Copyright © 2024 Elsevier Ltd. All rights reserved.)
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- 2024
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23. Registry-based study comparing health-related quality of life between patients with primary rectal cancer and locally recurrent rectal cancer.
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McKigney N, Downing A, Velikova G, Brown JM, and Harji DP
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- Humans, Male, Female, Aged, Middle Aged, Cross-Sectional Studies, Propensity Score, Patient Reported Outcome Measures, United Kingdom, Rectal Neoplasms pathology, Rectal Neoplasms psychology, Quality of Life, Registries, Neoplasm Recurrence, Local
- Abstract
Aim: National clinical registries offer the benefits of a comprehensive dataset, particularly when linked with patient-reported outcome (PRO) data. This aim of this study was to utilise UK registry data to assess cross-sectional differences in health-related quality of life (HrQoL) in patients with primary rectal (PRC) and locally recurrent rectal cancer (LRRC)., Materials and Methods: Data were extracted from the COloRECTal cancer Repository (CORECT-R) and the Locally Recurrent Rectal Cancer - Quality of Life (LRRC-QoL) datasets. Propensity score matching was undertaken in a 1:1 ratio using two covariates: age and sex. The primary outcome was the FACT-C Colorectal Cancer Subscale (CCS). Statistical significance was determined using p < 0.05 and clinical significance using effect size (ES) and minimally important clinical difference (MCID)., Results: A matched cohort with 72 patients in each group was identified. Overall FACT-C CCS scores were worse in patients with LRRC from a statistical (11.80 vs 18.03, p < 0.001) and clinically meaningful perspective (ES 1.63, MCID 6.23). Patients with PRC reported better digestion (p < 0.001, ES 0.85), better control over their bowels (p < 0.001, ES 1.03) and increased appetite (p < 0.001, ES 1.74, MCID 2.08). Patients with LRRC reported worse stomach swelling (p < 0,001, ES 0.97) and more diarrhoea (p < 0.001, ES 0.92), however they reported better body image (p < 0.001, ES 0.80)., Conclusion: Patients with LRRC reported significantly worse overall scores in the FACT-C CCS from both a statistical and clinical perspective, demonstrating the ability of the FACT-C to distinguish between these patient groups and the benefits of the inclusion of PROs within colorectal cancer registries, specifically including patients with advanced/recurrent disease., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)
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- 2024
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24. Agreement between patient-reported and clinician-rated speech and swallowing outcomes - Understanding the trend in post-operative oral cavity cancer patients.
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Balaji H, Aithal VU, Varghese JJ, Devaraja K, and Kumar ANN
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- Humans, Male, Female, Middle Aged, Prospective Studies, Aged, Deglutition physiology, Adult, Speech, Postoperative Period, Mouth Neoplasms surgery, Patient Reported Outcome Measures, Deglutition Disorders etiology, Deglutition Disorders physiopathology
- Abstract
Aim: To find the agreement between clinician-rated and patient-reported speech and swallowing outcomes in post-operative oral cavity cancer patients., Methods: In this prospective observational study, a total of 53 post-operative oral cavity cancer patients were recruited. The Speech Handicap Index - Kannada (SHI-K) and the Dysphagia Handicap Index - Kannada (DHI-K) were used as the patient-reported outcome measures (PROMs), and the Mann Assessment of Swallowing Ability-Cancer (MASA-C) and Ali Yavar Jung National Institute of Speech & Hearing Disabilities (DIVYANGJAN) AYJNISHD(D)'s speech intelligibility rating scale were used as the clinician-rated scales to evaluate speech and swallowing status., Results: Intraclass correlation coefficient (ICC) was poor, with a value of 0.480 between clinician-rated speech AYJNISHD(D)'s scale and patient-reported SHI-K scale. ICC was poor, with a value of 0.471 between clinician-rated swallowing MASA-C and patient-reported swallowing DHI-K., Conclusion: In our study, there was no agreement between patient-reported and clinician-rated speech and swallowing outcomes in post-operative oral cavity cancer patients. Incorporating PROMs into routine clinical practice is advisable, and clinicians need to balance PROMs with clinical and instrumental speech and swallowing assessments to ensure comprehensive care., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)
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- 2024
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25. Breast-cancer specific comprehensive archive of Patient-Reported Outcome Measures (PROMs) for clinical research and clinical practice in oncology: Results from the PRO4All project.
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Valsecchi AA, Giovanardi F, Malandrini F, Meregaglia M, Servetto A, Bennati C, Pinto C, Di Maio M, and Ciani O
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- Humans, Female, Surveys and Questionnaires, Medical Oncology, Self Report, Biomedical Research, Quality of Life, Minimal Clinically Important Difference, Patient Reported Outcome Measures, Breast Neoplasms therapy, Breast Neoplasms psychology
- Abstract
Background: Inclusion of patient-reported outcomes (PROs) in oncology clinical trials is strongly recommended. However, selecting the most appropriate patient-reported outcome measures (PROMs) is not easy. This study aimed to develop a breast cancer (BC) specific comprehensive archive of PROMs., Methods: As part of the PRO4All project, we identified available PROMs in oncology by searching facit.org, eortc.org, eprovide.mapi-trust.org, PubMed, ema.europa.eu (European Public Assessment Reports) and published reviews. For this analysis, only BC tools were extracted. We described information about PROM name, type of questionnaire, questionnaire variant(s), recall period, number of items, and presence of minimum clinically important difference (MCID) reference in literature. Then, we assigned each item to a specific domain according to a predefined taxonomy of 38 items for outcome classification., Results: We identified and analyzed 383 PROMs. Of these, 29 were BC specific, but 2 were excluded because the questionnaires description was not available. 6 (22.2 %) were variants of another questionnaire. All questionnaires were self-reported. In 6 cases (22.2 %) the recall period to consider was the "last week". The mean number of items per questionnaire was 25.81 (range 6-71). 602 items were assigned to an outcome domain: emotional functioning/wellbeing in 26.6 % of cases, physical functioning in 14.1 %, delivery of care in 10.8 %, and general outcomes in 10.5 %. MCID reference was found only in 4 (14.8 %) cases., Conclusions: The newly developed archive represents a useful tool to optimize the use of PROMs in the evaluation of treatments in BC patients, promoting a patient-centered approach both in clinical research and practice., Competing Interests: Declaration of competing interest F.G. reports honoraria from Eli Lilly, MSD, AstraZeneca, Novartis, Pfizer, Roche, Tesaro/GlaxoSmithKline. A.S. reports honoraria from Eli Lilly, MSD, AstraZeneca and Janssen; Travel support from Bristol-Myers Squibb, Roche and AstraZeneca; funding for research from AIRC. C.P. reports honoraria from Amgen, Astellas, AstraZeneca, Bayer, Bristol Meyer Squibb, Celgene, Clovis Oncology, Eisai, Ipsen, Janssen, Incyte, Merck-Serono, Merck Sharp and Dohme, Novartis, Roche, Sandoz, Sanofi, and Servier for consultancy or participation to advisory boards. M.D.M. reports honoraria from Amgen, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Janssen, Merck Serono, Merck Sharp & Dohme (MSD), Novartis, Pfizer, Roche, Takeda for consultancy or participation to advisory boards; direct research funding from Tesaro/GlaxoSmithKline, institutional funding for work in clinical trials/contracted research from Beigene, Exelixis, MSD, Pfizer and Roche. A.A.V.; C.B.; F.M.; M.M.; O.C. have declared no conflicts of interest., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)
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- 2024
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26. A systematic review and meta-analysis of risk factors influencing patient-reported arm symptoms post-breast cancer treatment: Accounting for radiotherapy impact.
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Liang Y, Zhou Y, Houben R, Verhoeven K, Rivera S, and Boersma LJ
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- Humans, Female, Risk Factors, Arm, Middle Aged, Axilla, Aged, Adult, Quality of Life, Breast Neoplasms radiotherapy, Breast Neoplasms pathology, Patient Reported Outcome Measures, Mastectomy, Lymph Node Excision
- Abstract
Objectives: To systematically review risk factors for patient-reported arm symptoms (AS) in breast cancer (BC), considering radiotherapy (RT) impact, using the EORTC QLQ-BR23 questionnaire (BR23)., Methods: PubMed, Embase, Cochrane Library, MEDLINE, and Web of Science were searched using the keywords "breast neoplasms", "radiotherapy", and "BR23" up to March 5th, 2024., Inclusion Criteria: both univariate and multivariate analyses., Exclusion Criteria: pregnancy, recurrence, distant metastasis BC, reirradiation, or lack of RT. The risk of bias of included papers was assessed using the Critical Appraisal Skills Program (CASP) checklist. Descriptive and meta-analyses were conducted using risk ratio (RR) or standardized mean difference (SMD) with 95 % confidence intervals (CI) as effect measures. A random-effects model was applied if I
2 > 50 %., Results: Eighteen out of 734 studies were included, with sample sizes ranging from 172 to 2208. Commonly reported risk factors included axillary lymph node dissection (ALND), mastectomy, chemotherapy (CT), and RT (6, 5, 4, and 4 studies, respectively). In meta-analyses, ALND was a risk factor for arm pain (RR [95 % CI] = 1.75 [1.14; 2.71]), lymphedema (RR [95 % CI] = 5.41 [3.48; 8.39]), and overall AS (SMD [95 % CI] = 0.49 [0.14; 0.83]) compared to sentinel lymph node biopsy. RT was not a risk factor, but axillary RT significantly increased overall AS (SMD [95 % CI] = 0.55 [0.40; 0.70]) compared to no axillary RT., Conclusion: ALND and mastectomy were the primary risk factors for patient-reported AS. Axillary RT was a significant risk factor, whereas general RT was not., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)- Published
- 2024
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27. Untapping the Prognostic Value of Patient-Generated Health Data in Locally Advanced Non-small Cell Lung Cancer.
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Ohri N, Bodner W, Garg M, Stiles B, Halmos B, and Kalnicki S
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- Humans, Male, Prognosis, Female, Middle Aged, Aged, Chemoradiotherapy, Prospective Studies, Survival Rate, Surveys and Questionnaires, Cohort Studies, Quality of Life, Carcinoma, Non-Small-Cell Lung pathology, Carcinoma, Non-Small-Cell Lung therapy, Carcinoma, Non-Small-Cell Lung mortality, Lung Neoplasms pathology, Lung Neoplasms therapy, Lung Neoplasms mortality, Patient Reported Outcome Measures
- Abstract
Background: Patient-generated health data (PGHD), which includes patient-reported outcomes (PROs) and wearable device data, may have prognostic value for cancer patients. We tested that hypothesis using data from several prospective trials where patients with locally advanced non-small cell lung cancer (LA-NSCLC) were treated with definitive chemoradiotherapy., Methods: Cox proportional hazards models were utilized to identify the baseline patient-reported symptom that best predicted progression-free survival (PFS) duration in a trial that involved PRO-CTCAE collection (Cohort 1). Using data from trials that included EORTC QLQ-C30 questionnaires and wearable devices (Cohort 2), the same symptom was tested as a predictor of PFS. Baseline physical inactivity was also tested as a predictor of PFS. A simple risk stratification tool utilizing PROs and physical activity was proposed., Results: In Cohort 1 (n = 50), anorexia was the only pretreatment PRO that was significantly associated with PFS after Bonferroni correction (HR = 3.94, P = .002). In Cohort 2 (n = 58), baseline anorexia was also significantly associated with PFS (HR = 2.48, P = .018), as was physical inactivity (HR = 3.11, P < .001). Median PFS duration for patients in Cohort 2 with anorexia or physical inactivity was 6 months, compared to 18 months for other patients (HR = 3.08, P < .001). Median overall survival duration for patients with anorexia or physical inactivity was 19 months, compared to 65 months for other patients (HR = 2.44, P = .021)., Conclusion: PGHD, including PROs and wearable device data, can provide valuable prognostic information for LA-NSCLC patients treated with definitive chemoradiotherapy. These findings should be validated using larger datasets., Competing Interests: Disclosure The authors have no disclosures that are directly related to this work., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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28. Identifying Palliative Care Needs in Patients With Heart Failure Using Patient Reported Outcomes.
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Lykke C, Jurlander B, Ekholm O, Sjøgren P, Juhl GI, Kurita GP, Larsen S, Tønder N, Høyer LV, Eidemak I, and Zwisler AD
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- Humans, Male, Female, Aged, Middle Aged, Cross-Sectional Studies, Aged, 80 and over, Adult, Denmark, Quality of Life, Needs Assessment, Palliative Care, Heart Failure therapy, Patient Reported Outcome Measures
- Abstract
Context: Heart failure (HF) is considered a multifaceted and life-threatening syndrome characterized by high symptom-burden and significant mortality., Objectives: To describe the symptom-burden in patients with HF and identify their palliative care needs. In this respect, symptom burden related to sex, age and classification of HF using New York Heart Association Functional Classification (NYHA) were analyzed., Methods: A cross-sectional questionnaire survey included adult HF patients according to NYHA II, III, and IV. Palliative care needs were assessed using validated patient reported outcomes measures; SF-36v1, HeartQoL, EORTC- QLQ-C15-PAL, MFI-20 and HADS. Patients were recruited from the Department of Cardiology, North Zealand Hospital, Denmark., Results: In total, 314 patients (79%) completed the questionnaire (233 men). Mean age = 74 years (range 35-94 years). In all, 42% had NYHA III or IV and 53% self-rated their health to be fair or poor. In all, 19% NYHA II and 67% NYHA III/IV patients had ≥4 severe palliative symptoms according to EORTC-QLQ-C15-PAL. In addition, NYHA III/IV had a mean of 8.9 symptoms and a mean of 5.4 severe symptoms. Women, older patients, and those with NYHA III/IV had worse outcomes regarding health-related quality of life, functional capacity, and symptom burden., Conclusions: Patients with HF have a high prevalence of symptoms and, thus, potential palliative care needs. Predominantly, women, older patients, and those with higher severity of disease have the highest symptom burden. PROMs can help cardiologists address the palliative care needs and systematic assessment may be a prerequisite to integrate symptom-modifying and palliative care interventions., (Copyright © 2024 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)
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- 2024
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29. The PROPr can be measured using different PROMIS domain item sets.
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Klapproth CP, Fischer F, Doehmen A, Kock M, Rohde J, Rieger K, Keilholz U, Rose M, and Obbarius A
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- Humans, Female, Male, Middle Aged, Aged, Adult, Surveys and Questionnaires, Patient Reported Outcome Measures, Neoplasms
- Abstract
Background: The Patient-Reported Outcomes Measurement Information System (PROMIS) Preference Score (PROPr) is estimated from descriptive health assessments within the PROMIS framework. The underlying item response theory (IRT) allows researchers to measure PROMIS health domains with any subset of items that are calibrated to this domain. Consequently, this should also be true for the PROPr. We aimed to test this assumption using both an empirical and a simulation approach., Methods: Empirically, we estimated 3 PROMIS Pain inference (PI) scores from 3 different item subsets in a sample of n=199 cancer patients: 4 PROMIS-29 items (estimate: θ
4 ), the 2 original PROPr items (θ2 ), and 10 different items (θ10 ). We calculated mean differences and agreement between θ4 , and θ2 and θ10 , respectively, and between their resulting PROPr4 , PROPr2 , PROPr10 , using intraclass correlation coefficients (ICC) and Bland-Altman (B-A) plots with 95 %-Limits of Agreement (LoA). For the simulation, we used the IRT-model to calculate all item responses of the entire 7 PROPr domain item banks from the empirically observed PROMIS-29+cognition θ. From these simulated item banks, we chose the 2 original PROPr items per domain to calculate PROPrsim and compared it to PROPr4 again using ICC and B-A plots., Results: θ4 vs θ10 showed smaller bias (-0.012, 95 %-LoA -0.88;0.85) than θ4 vs θ2 (0.025, 95 %-LoA -0.95;1.00. ICC>0.85 (p<0.001) in both θ-comparisons. PROPr4 vs PROPr10 showed lower bias (0.0012, 95 %-LoA -0.039;0.042) than PROPr4 vs PROPr2 (-0.0029, 95 %-LoA -0.049;0.044). ICC>0.98 (p<0.0001) on both PROPr-comparisons. Mean PROPrsim was larger than mean PROPr4 (0.0228, 95 %-LoA -0.1103; 0.1558) and ICC was 0.95 (95 %CI 0.93; 0.97)., Conclusion: Different item subsets can be used to estimate the PROMIS PI for calculation of the PROPr. Reduction to 2 items per domain rather than 4 does not significantly change the PROPr estimate on average. Agreements differ across the spectrum and in individual comparisons., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)- Published
- 2024
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30. Anxiety in patients with venous thromboembolism: quantification and risk factors in a prospective cohort study.
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Steiner D, Nopp S, Hoberstorfer T, Pabinger I, Weber B, and Ay C
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- Humans, Female, Male, Prospective Studies, Middle Aged, Risk Factors, Adult, Time Factors, Sex Factors, Patient Reported Outcome Measures, Aged, Anxiety epidemiology, Anxiety diagnosis, Venous Thromboembolism epidemiology, Venous Thromboembolism psychology, Venous Thromboembolism diagnosis, Pulmonary Embolism psychology, Pulmonary Embolism diagnosis, Venous Thrombosis epidemiology, Venous Thrombosis psychology, Venous Thrombosis diagnosis
- Abstract
Background: Patients with venous thromboembolism (VTE) are at risk of psychological consequences. However, as opposed to physical sequelae of VTE, mental health issues are understudied., Objectives: To assess anxiety after VTE and investigate associated clinical characteristics., Methods: We conducted a prospective cohort study, including patients with acute deep vein thrombosis (DVT) and/or pulmonary embolism. Patients with cancer, pregnancy, or puerperium were excluded. Anxiety was assessed with the Patient-Reported Outcome Measurement Information System short form 8a. Standardized T-scores were calculated (reference, 50; SD, 10), with higher values indicating more anxiety. We associated clinical characteristics at baseline with T-scores at 3-month follow-up in a multivariable linear regression model. Patient clusters depending on anxiety trajectories were explored., Results: We included 257 patients (38.5% women) with a median (IQR) age of 54.1 (42.2-63.5) years. While mean (SD) T-scores decreased from baseline to follow-up (51.03 [9.18] to 46.74 [8.89]; P < .001), we observed an increase in 23.7% of all patients. Female sex (T-score change, 3.09; 95% CI, 0.96-5.22), older age until 45 years, and anxiety at baseline were associated with increased T-scores at follow-up. VTE history (-1.55; 95% CI, -3.62 to 0.52) and pulmonary embolism (-1.23; 95% CI, -3.16 to 0.69) were associated with reduced T-scores, albeit not reaching statistical significance. In a cluster of older female patients with DVT, anxiety tended to increase over time., Conclusion: While most patients with VTE reported reduced anxiety over time, some patients experienced worsening. Female sex, older age, more anxiety at baseline, no VTE history, and DVT were associated with increased anxiety 3 months after VTE., Competing Interests: Declaration of competing interests C.A. reports honoraria for lectures from Bayer, Daiichi Sankyo, BMS/Pfizer, and Sanofi and participation in advisory boards for Bayer, Daiichi Sankyo, BMS/Pfizer, and Sanofi outside the current work. D.S., S.N., T.H., I.P., and B.W. have no conflicts of interest to declare with regard to the present study., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2024
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31. Development of a prototype of a patient-reported outcomes measure for hypospadias care, the Patient Assessment Tool for Hypospadias (PATH).
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Brown C, Larson K, Cockrum B, Hawryluk B, Moore CM, Wiehe SE, and Chan KH
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- Humans, Male, Adolescent, Young Adult, Adult, Quality of Life, Surveys and Questionnaires, Self Report, Hypospadias psychology, Patient Reported Outcome Measures
- Abstract
Introduction/background: Patient-reported outcome measures (PROMs) for hypospadias care are lacking, and most existing instruments were developed without patient input., Objective: The objective of this study was to 1) use our previously developed Hypospadias Journal for concept elicitation in a sample of adolescent and young adult hypospadias patients and 2) develop a new hypospadias PROM., Study Design: We recruited English-speaking males ages 13-30 living in the United States with a self-reported history of hypospadias through targeted advertisements on Facebook and Instagram from March to June 2022. Using a Qualtrics screening survey ineligible respondents were identified using automated fraud detection and manual review. Consenting participants were sent an electronic Hypospadias Journal containing brief creative writing exercises and multiple-choice scales to facilitate participant reflections about genital appearance, urination, sexual function, and psychosocial well-being. Demographics were summarized using descriptive statistics. Human-centered design researchers synthesized the journals' key themes to 1) create an affinity diagram with hypospadias-related quality of life (QOL) domains and 2) draft items for the PROM covering each domain and sub-domain. Journal participants were asked to complete a survey to 1) rank hypospadias QOL domains, subdomains, and draft items for the PROM, and 2) explore their preferences for item phrasing. In a small group virtual interview, a urologist and a hypospadias patient reviewed and revised draft PROM items, and a final PROM was created., Results: Of the 411 completed screening surveys, 391 were ineligible. Journals were sent to 20 eligible participants. Of these, 12 completed journals: 8 adults; 4 adolescents (11 surgical/1 non-surgical): 66.7% White, 8.3% Black, 16.7% Asian, 8.3% >1 race. The meatal location was distal for 41.7%, proximal for 41.7%, unknown/missing for 16.7%. We identified four hypospadias-related quality-of-life domains and 13 respective sub-domains (Extended Summary Figure) of these, two were novel domains: 1) knowledge about the condition/treatment and comfort with treatment decision, and 2) impact on relationships with caregivers, medical providers, and sexual partners. A final PROM prototype, the Patient Assessment Tool for Hypospadias (PATH) was created, covering all QOL domains identified by participants., Discussion: We created a simple, brief hypospadias PROM to screen for salient topics to be addressed by providers in the clinical setting. Limitations include the small sample size and limited clinical details about participants., Conclusions: Our study provides a hypospadias PROM that is ready for psychometric assessment in a larger sample., (Copyright © 2024 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.)
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- 2024
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32. Telehealth visit type and patient-reported outcomes among patients with cancer.
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Carson DS, Simpson S, Gadzinski AJ, Holt SK, Stewart B, Wolff EM, Ellimoottil C, and Gore JL
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- Humans, Male, Female, Middle Aged, Aged, Urologic Neoplasms therapy, Urologic Neoplasms economics, SARS-CoV-2, Adult, Telemedicine economics, Telemedicine statistics & numerical data, Patient Reported Outcome Measures, COVID-19 epidemiology, COVID-19 economics, Patient Satisfaction statistics & numerical data
- Abstract
Background: Relaxed licensing restrictions on telehealth use during the COVID-19 pandemic allowed broad use irrespective of visit type. As these telehealth waivers expire, optimal uses of telehealth must be assessed to inform policy and clinical care. We evaluated patient experience associated with telehealth and in-person new or established visits., Methods: Patients seen in-person and via telehealth for urologic cancer care from August 2019 to June 2022 received a survey on satisfaction with care, perceptions of communication during their visit, travel time, travel costs, and days of work missed. We assessed survey responses with descriptive statistics., Results: Surveys were completed for 1,031 patient visits (N = 494 new visits, N = 537 established visits). Satisfaction rates were high for all visit modalities among new and established patients (mean score range 59.9-60.7 [maximum 63], P > 0.05). Patient-rated quality of the encounter did not differ by visit type and modality (P > 0.05, for nearly all comparisons). New in-person patient visits were associated with significantly higher travel costs (mean $496.10, SD $1021) compared with new telehealth visits (mean $26.60, SD $141; P < 0.001); 27% of new in-person patients required plane travel and 41% required a hotel stay (P < 0.001 vs. 0.8% and 3.2% of new telehealth patients, respectively)., Conclusions: Satisfaction outcomes among patients with urologic cancer receiving new patient telehealth care equaled those of new patients cared for in-person while costs were significantly lower. Offering telehealth exemption beyond COVID-19 licensing waivers to include new patient visits would allow for ongoing delivery of high-quality urologic cancer care irrespective of geographic location., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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33. Translation, cross-cultural adaptation, and clinimetric properties evaluation of the Danish version of the Anterior Cruciate Ligament - Return to Sport after Injury scale (ACL-RSI).
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Bjerregaard A, Kjeldgaard E, Wøbbe KN, Køllner Olsen C, Barfod KW, and Korakakis V
- Abstract
Purpose: To translate and cross-cultural adapt the Anterior Cruciate Ligament-Return To Sport After Injury (ACL-RSI) questionnaire into Danish (ACL-RSI-DK) and evaluate the psychometric properties with the purpose to identify the psychological readiness on returning to sport (RTS)., Methods: The ACL-RSI-DK followed a six-step translation and cultural-adaptation process. Statistical analysis included correlation for construct validity of the ACL-R-DK with the Lysholm, KOOS and K-SES. Moreover, we assessed reliability using Cronbach's alpha and ICC and used Bland Atman methods to assess bias between test and re-test. An exploratory factor-analysis was used for the dimensionality of ACL-RSI-DK., Results: 102 Danish individuals (Female 49%, age 27.7 ± 7.3 years), 51.2 (±15.5) weeks post-op from anterior cruciate ligament reconstruction (ACLR) were included. The ACL-RSI-DK showed excellent internal consistency (Cronbach's alpha 0.957) and test-retest reliability (ICC = 0.96), with no floor or ceiling effects. The Bland Atman analysis showed no systematic bias. The mean score was 48 ± 23 out of 100 points. The SEM was calculated to be 5/10 points and the MDC
95 was 13/100. The construct validity evaluation presented strong correlation between ACL-RSI-DK, K-SES (ρ = 0.63) and KOOS-Sport (ρ = -0.63), whereas a moderate correlation was found with Lysholm (ρ = 0.48) and KOOS (ρ = -0.58) and its subscales KOOS-Symptoms (ρ = -0.27), KOOS-Pain (ρ = -0.43), KOOS-ADL (ρ = -0.47) and KOOS-QoL (ρ = -0.59. ACL-RSI-DK was found to be an unidimensional scale with a total variance explained of 68.5%., Conclusion: The ACL-RSI was successfully translated and cross-cultural adapted into Danish and displayed good psychometric properties. The ACL-RSI-DK is a valid and reliable tool to investigate the psychological readiness on RTS., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)- Published
- 2024
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34. Patients with Associated Spine or Other Major Joint Pain have Equivalent Outcomes to Patients with Isolated Hip Pain after Hip Arthroscopy.
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Alrashedan BS, Remedios S, and Wong I
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Objectives: This study aims to evaluate the outcomes of patients following surgery diagnosed with femoroacetabular impingement syndrome (FAIS) who also experience low back and other joint pain, compared to those with isolated hip pain., Methods: This is a retrospective cohort study of patients diagnosed with FAIS with or without other joint pain treated with hip arthroscopy from 2016 - 2020. Excluded cases were patients who had significant arthritis, irreparable labral tear requiring reconstruction, or were lost follow-up. Analysis was carried out in two ways, the first was according to musculoskeletal morbidity (MSKM) scheme where patients were stratified into four different groups, and the second was according to the presence of any other joint or back pain (MSKM 2-4) compared to hip pain only (MSKM 1). Demographic data was analyzed between the groups. International Hip Outcome Tool 33 (iHOT-33) and Hip Outcome Score (HOS) were used as the primary and secondary outcome measures pre-operatively and a minimum of two year post-operatively., Results: A total of 131 patients were included in the study with 37% males and 63% females. Age (years) and body mass index (kg/m
2 ) were similar between groups, whereas a statistically significant greater number of male participants were seen in the hip pain only group (MSKM 1). Pre-operatively, patients with isolated hip pain (MSKM 1), had statistically significantly higher iHOT-33 scores (p < 0.05), but no statistically significant differences were observed post-operatively between the groups. All groups demonstrated a statistically significant improvement in iHOT-33 and HOS scores post operatively compared to pre-operatively scores (p < 0.05), with 76% meeting the threshold for minimum clinically important difference., Conclusion: Patient reported outcomes following hip arthroscopy for FAIS were significantly greater post-operatively for all patients, despite the presence of other joint or back pain. This study can assist in driving patient expectations following hip arthroscopy for FAIS., Level of Evidence: IV., Competing Interests: Declaration of Competing Interest ☒ The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. ☒ The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. ☒ The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Ivan Wong reports a relationship with DePuy Mitek Inc that includes: consulting or advisory and speaking and lecture fees. Dr. Ivan Wong reports a relationship with Smith and Nephew Inc that includes: consulting or advisory and speaking and lecture fees. Dr. Ivan Wong reports a relationship with CONMED Corp that includes: consulting or advisory and speaking and lecture fees. Dr. Ivan Wong reports a relationship with Bioventus LLC that includes: speaking and lecture fees. Dr. Ivan Wong is an editorial board member for the American Journal of Sports Medicine (AJSM) and Arthroscopy: The Journal of Arthroscopic and Related Surgery (ARTH); and is a board of committee member for AANA, ISAKOS, and AAC. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)- Published
- 2024
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35. French translation and transcultural adaptation of the shoulder pain and disability index (SPADI).
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Lathiere T, Chantriaux N, Beard D, Pinsault N, and Druart L
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- Humans, Male, Female, Adult, Middle Aged, Reproducibility of Results, Surveys and Questionnaires, Pain Measurement methods, Psychometrics, Translating, Cross-Cultural Comparison, Aged, Patient Reported Outcome Measures, Shoulder Pain diagnosis, Shoulder Pain physiopathology, Disability Evaluation, Translations
- Abstract
Background: A French version of the Shoulder Pain and Disability Index (SPADI) is currently unavailable for clinical and research use in French-speaking countries., Objectives: To translate and transculturally adapt the Shoulder Pain And Disability Index (SPADI) from English to French language., Design: Translation and transcultural adaptation of a Patient-Reported Outcome Measure., Methods: Following international guidelines for translating and adapting PROMs, we carried out a seven-step process involving 15 contributors. The forward translation was performed by five independent native French speakers, while five independent native English speakers conducted the blinded back-translation. A bilingual expert committee synthesized the translations, and three healthcare professionals participated in the pre-test phase. Ten patients were involved in pre-testing to evaluate the pre-final version., Results: A final French version of the SPADI was achieved after making seven adjustments across the 18 items, instructions, and examples on the Likert scale. Changes were implemented only if at least 20% of the pre-test participants suggested modifications to enhance readability or coherence. Face validity was assessed by the expert committee., Conclusion: The French version of the SPADI is now available, enabling condition-specific self-assessment and quantitative follow-up of shoulder pain and function in both clinical practice and research. Although psychometric properties of this version are yet to be assessed, future studies are expected to confirm the preservation of the original tool's validity and reliability., Competing Interests: Declaration of competing interest The authors declare that they have no conflict of interest regarding this paper and its publication. This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)
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- 2024
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36. The use of respiratory patient reported outcome measures (PROMs) in the management of COPD: Perceptions of Australian osteopaths.
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Engel R, Baxter D, Muddle L, Vaughan B, and Grace S
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- Humans, Australia, Male, Female, Middle Aged, Adult, Osteopathic Physicians, Attitude of Health Personnel, Patient Reported Outcome Measures, Pulmonary Disease, Chronic Obstructive therapy, Quality of Life
- Abstract
Background: Patient reported outcome measures (PROMs) are widely used to capture patients' perspectives of their health status and treatment outcomes and to enable practitioners to evaluate the effectiveness of interventions. The aim of this study was to explore Australian osteopaths' perceptions of the use of respiratory PROMS in the management of chronic lung conditions., Methods: This study drew on the social ecological model (SEM), which highlights the interdependence of contextual structures and processes. Osteopaths who were initially part of a larger mixed-methods study were invited to participate in semi-structured interviews. Transcripts were thematically analysed using the SEM., Results: Seven of the original study osteopaths were interviewed. When presented with a patient who had a co-morbid respiratory condition, they focused on the musculoskeletal aspects of that condition (intrapersonal factors). Participants described sporadic use of musculoskeletal and quality of life PROMs in practice, and scarce use of respiratory PROMs (intrapersonal and organizational factors). Participants' perceptions of their scope of practice strongly influenced their use of respiratory PROMs (environmental factors)., Conclusion: Intrapersonal and environmental factors were dominant drivers for participants' scant use of respiratory PROMs. Further education on the scope and contribution of osteopaths to the management of chronic lung conditions and the use of respiratory PROMS is called for to promote multidisciplinary patient care., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)
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- 2024
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37. Influence of nationality on the trajectories of pain, disability and health related quality of life in neck and back patients - The Norwegian Neck and Back Registry.
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Ignatius JS, Røe C, Perrin PB, Skatteboe S, Brox JI, Kielland MG, and Bjørneboe J
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- Humans, Norway, Male, Female, Middle Aged, Adult, Back Pain psychology, Pain Measurement, Aged, Disabled Persons psychology, Patient Reported Outcome Measures, Quality of Life psychology, Registries, Neck Pain psychology, Neck Pain physiopathology, Disability Evaluation
- Abstract
Purpose: The aim of the current study was to examine differences in trajectories of pain, disability, and health related quality of life (HRQOL) between non-Norwegian and Norwegian patients with neck and back pain over 12 months., Methods: The study is based on data from the Norwegian Neck and Back Registry (NNRR). The data include demographics and patient-reported outcome measures such as pain rating, the Oswestry Disability Index and HRQOL. Data were collected at baseline, 6 and 12 months after consultation for neck and back pain in specialist health care., Results: A total of 5012 patients were included. We found a significant main effect of nationality. Non-Norwegian patients showed higher levels of pain and disability and lower HRQOL than Norwegian patients. Both patient groups exhibited an improvement in all three outcomes at 6- and 12-month follow-ups. The improvement was similar for pain with the greatest improvement taking place during the first 6 months and then slightly flattening out. For disability and HRQOL, we observed a differential effect over time as a function of nationality. Both groups reported an improvement the first 6 months, however, while the Norwegian patients continued their improvement to 12 months, non-Norwegian patients had increasing disability and lower HRQOL at 12 months., Conclusion: Both patient groups improved over the 12-month period. Non-Norwegian patients showed an overall higher level of pain, disability and lower HRQOL compared to Norwegian patients, with a differential effect over time as a function of nationality for disability and HRQOL. Suggesting that future studies should focus on potential systemic barriers that may affect the recovery of neck and back patients based on nationality., Competing Interests: Declaration of competing interest The authors have no relevant financial or non-financial interests to disclose., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
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- 2024
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38. A 7-item Tampa Scale for Kinesiophobia in people with femoroacetabular impingement syndrome: evaluation of structural validity, hypothesis testing, internal consistency and minimally important change.
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Murphy MC, Rio EK, Scholes MJ, Jones DM, Pazzinatto M, Johnston RT, Coburn SL, and Kemp JL
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- Humans, Male, Female, Cross-Sectional Studies, Adult, Reproducibility of Results, Psychometrics, Cohort Studies, Young Adult, Surveys and Questionnaires, Patient Reported Outcome Measures, Phobic Disorders psychology, Factor Analysis, Statistical, Kinesiophobia, Femoracetabular Impingement psychology
- Abstract
Background: The 17-item Tampa Scale for Kinesiophobia (TSK) is a commonly used patient-reported outcome measure (PROM) to assess kinesiophobia, but the measurement properties of the TSK in people with femoroacetabular impingement syndrome (FAIS) are unknown., Objectives: 1) Revise the existing TSK by removing items, as needed, with inadequate functioning to optimise the TSK for people with FAIS, and 2) evaluate construct validity (both structural validity and hypothesis testing), internal consistency, and minimal important change., Methods: Cross-sectional cohort study including 153 young adults with FAIS. Exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) were used to evaluate structural validity and the TSK was revised to remove items with poor function, improving CFA model fit. Hypothesis testing, internal consistency (Cronbach's α) and minimal important change (distribution-based method) were also evaluated., Results: A 7-item version of the TSK provided the best CFA model fit with 10-items functioning poorly and needing to be removed. The 7-item TSK was uni-dimensional (single factor in EFA) and had adequate structural validity (Standardised Root Measure Square = 0.0771). The 7-item TSK had insufficient hypothesis testing with moderate correlations to 8/14 PROMs measuring different constructs. The 7-item TSK had adequate internal consistency (α = 0.783). The minimal important change of the 7-item TSK was 6.00 points (0-100 point scale)., Conclusion: We found that the '7-item TSK for FAIS', had superior structural validity to the original 17-item scale, suggesting that it may be more appropriate for use in this population. Further studies should evaluate other measurement properties of the 7-item scale., Competing Interests: Declaration of competing interest Myles C Murphy, Ebonie K Rio, Mark J Scholes, Sally L Coburn, Denise M Jones, Marcella Pazzinatto, Richard TR Johnston, and Joanne L Kemp declare no competing interests related to this research., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)
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- 2024
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39. There is no correlation between differences in adverse events and differences in patient-reported outcome measures in orthopaedic trauma randomized controlled trials: A systematic review.
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Parry JA, Salimi M, Stacey SC, and Mauffrey C
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- Humans, Postoperative Complications, Randomized Controlled Trials as Topic, Fractures, Bone surgery, Patient Reported Outcome Measures
- Abstract
Introduction: A recovery without adverse events is a top priority of orthopaedic trauma patients, however many randomized controlled trials (RCTs) are only powered to detect a difference in patient-reported outcome measures (PROMs). While it may be assumed that differences in major adverse event rates between treatment groups will result in differences in PROMs, this has not been established. The purpose of this study was to perform a systematic review of RCTs to evaluate if differences in these outcomes were correlated., Methods: A systematic search was conducted of online databases to identify RCTs in orthopaedic trauma fracture management that reported both major adverse events and PROMs. Adverse events included secondary surgeries or complications that could negatively affect long-term outcomes (nonunion, chronic regional pain syndrome, etc.). The correlation between a difference (p < 0.05) in adverse events and a difference in PROMs was assessed., Results: The systematic review yielded 30 RCTs involving 6,769 patients. The primary outcome was a continuous PROM in 70.0 % (21/30). A difference in major adverse events was reported in 23.3 % (7/30) and a difference in PROMs was reported in 6.7 % (2/30). Studies reporting a difference in adverse events, compared to those that did not, were not more likely to report a difference in PROMs (14.3 % (1/7) vs. 4.3 % (1/23); p = 0.42)., Conclusions: There was no correlation between differences in adverse event rates and differences in PROMs in orthopaedic trauma RCTs. Investigators should consider powering studies to detect differences in the major adverse events that both patients and surgeons wish to avoid., Level of Evidence: Level I., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)
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- 2024
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40. Symptom severity reported by older adults with cancer and its impact on survival prognostication.
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Goh WY and Hum AYM
- Subjects
- Humans, Male, Aged, Female, Aged, 80 and over, Prognosis, Age Factors, Middle Aged, Symptom Assessment, Proportional Hazards Models, Palliative Care, Fatigue, Anxiety, Neoplasms mortality, Severity of Illness Index
- Abstract
Introduction: Symptom burden is a crucial factor for survival prognostication, but older adults may report fewer and less severe symptoms than younger patients. We investigated the impact of age on symptom severity and its prognostic implications in the prognostic model for advanced cancer (PRO-MAC)., Materials and Methods: Eight hundred forty subjects with incurable cancer, who were reviewed by palliative medicine at a tertiary university hospital, were categorized into four groups based on age: < 65 (young), 65-74 (young-old), 75-84 (old-old), and ≥ 85 (oldest-old) for comparison. The study compared individual symptoms reported on the Edmonton Symptom Assessment System-revised (ESAS-r) and analyzed the significance of each prognostic variable in the PRO-MAC model using multivariate Cox proportional hazards regression analysis for all age categories. We generated the log-rank test for each age group to evaluate the effectiveness of PRO-MAC across age groups., Rsults: The older adults had significantly lower unadjusted mean scores in pain, tiredness, anxiety, wellbeing, and ESAS-r summative score compared to young adults. There was a higher proportion of older adults with no symptoms. The ESAS-r summative score remained a significant prognostic factor only in the young and young-old groups. More participants in the older age groups had dementia, which may impact reporting of symptom severity. Despite these findings, the PRO-MAC model remains applicable across all age groups as a multi-domain 90-day survival prognostication tool., Discussion: Symptom burden, including pain, tiredness, anxiety, wellbeing, as well as summative ESASr scores, are lower in older adults with cancer. This could affect the prognostication of survival using symptom burden. However, a multi-dimensional prognostic model like PRO-MAC remains effective for older adults with advanced cancer. Further research is needed to explore tools that can help older adults express the severity of their symptoms and incorporate this into survival prognostication., Competing Interests: Declaration of Competing Interest The authors have no competing interests to declare., (Copyright © 2024. Published by Elsevier Ltd.)
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- 2024
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41. Severity Scores for Cutaneous Lupus Erythematosus.
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Cepica TB, Gupta R, Werth VP, and Chong BF
- Subjects
- Humans, Patient Reported Outcome Measures, Reproducibility of Results, Lupus Erythematosus, Cutaneous diagnosis, Lupus Erythematosus, Cutaneous pathology, Psychometrics methods, Quality of Life, Severity of Illness Index
- Abstract
Despite the significant disease burden of cutaneous lupus erythematosus (CLE), there have been no United States Food and Drug Administration-approved therapies for 65 years. To facilitate advancement of therapies, severity scores are needed to evaluate QOL, how patients feel, activity of disease, and organ-specific damage to assess response to therapies and disease progression. In this paper, we delineate the development process of provider- and patient-reported severity scores for CLE. Cutaneous Lupus Disease Area and Severity Index (CLASI), a provider-reported measure that distinguishes between activity and damage, has undergone rigorous validation and reliability testing for over 20 years. Its performance has been tested in clinical trials as a primary or secondary endpoint and tool to stratify patients. As an objective disease measure that captures a provider's perspective of disease activity and damage, the CLASI inherently does not assess disease impact on patients' QOL. Cutaneous Lupus Erythematosus Quality of Life (CLEQoL), a patient-reported measure, captures features elucidated through focus groups, including symptoms, emotions, functioning, body image, and photosensitivity. It has undergone psychometric property testing to ensure reliability and validity. Together, CLASI and CLEQoL are simple and reliable CLE-specific severity scores capturing disease activity, damage, and QOL from provider and patient perspectives., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2024
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42. The patient-reported outcomes for the new brand-generic teriflunomide in relapsing-remitting multiple sclerosis.
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Abolfazli R, Nabavi SM, Azimi A, Nahayati M, Gharagozli K, Torabi H, Ghazaeian M, Rezagholi Z, and Samadzadeh S
- Subjects
- Humans, Male, Female, Adult, Middle Aged, Medication Adherence, Treatment Outcome, Drugs, Generic therapeutic use, Young Adult, Crotonates therapeutic use, Toluidines therapeutic use, Hydroxybutyrates, Nitriles therapeutic use, Multiple Sclerosis, Relapsing-Remitting drug therapy, Patient Reported Outcome Measures, Patient Satisfaction
- Abstract
Background: Patient-reported outcomes (PROs) provide valuable insights into the impact of disease-modifying therapies (DMTs) on patients' daily lives and disease progression. This study evaluates treatment satisfaction and tolerability among patients using a brand-generic Teriflunomide (Tebazio®, 14 mg tablet) manufactured by Zistdaru Danesh Biopharmaceuticals., Materials and Methods: A Phase IV observational study was conducted on patients with Relapsing-Remitting Multiple Sclerosis (RRMS) who were either initiated on or switched to Teriflunomide 14 mg. The primary focus was on the medication's safety. Patient satisfaction was measured using the Treatment Satisfaction Questionnaire for Medication [Version 1.4] (TSQM-14). Additionally, medication adherence and discontinuation rates were monitored., Results: Of the 235 RRMS patients enrolled, participated in this study, all received the Teriflunomide treatment orally on a daily basis. Over the 18-month follow-up period, 25.96 % of patients discontinued the treatment. Discontinuation was mainly due to adverse events (11 %), lack of patient willingness to continue (12.7 %), and disease progression (4.2 %). The most commonly reported adverse events included dermatologic disorders, elevated liver enzymes, and gastrointestinal issues. TSQM-14 scores demonstrated significant improvements over the 18-month period. A high medication adherence rate of 98.1 % was also recorded., Conclusion: Patients reported notable satisfaction with Teriflunomide, as reflected in their TSQM scores, which suggests a likelihood of improved patient adherence. The 14 mg brand-generic Teriflunomide was well-accepted by Iranian RRMS patients, with no significant concerns arising during the study. These findings also highlight the significance of patient-reported outcomes in DMTs, with potential benefits for adherence and clinical practice., Competing Interests: Declaration of Competing Interest All authors declare that they have no financial, personal, or other interests related to the subject matter of this paper that could create a potential conflict of interest., (Copyright © 2024 Elsevier B.V. All rights reserved.)
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- 2024
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43. Long-term results and patient-reported outcomes after vascularized fibular graft use in the treatment of post-traumatic bone defects of femur shaft and tibia: A retrospective cohort and cross-sectional survey study.
- Author
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Noorlander-Borgdorff MP, Alkemade E, van der Sluis WB, de Jong T, Driessen C, Giannakópoulos GF, Smit JM, van Embden D, Winters H, and Botman M
- Subjects
- Humans, Cross-Sectional Studies, Male, Female, Retrospective Studies, Adult, Middle Aged, Tibia surgery, Tibia transplantation, Femur transplantation, Femur surgery, Patient Satisfaction, Plastic Surgery Procedures methods, Treatment Outcome, Fibula transplantation, Fibula blood supply, Patient Reported Outcome Measures, Bone Transplantation methods, Quality of Life
- Abstract
Objectives: Post-traumatic critical-sized bone defects pose a reconstructive challenge for reconstructive surgeons. The vascularized fibula graft is a well-described treatment for osseous defects of the femur and tibia. This study aimed to assess long-term patient-reported quality of life, the success-, and complication rates in lower extremity reconstruction with vascularized fibula grafts., Methods: A retrospective cohort of 29 patients who underwent fibula graft reconstruction for critical-sized bone defects after post-traumatic tibial and femoral bone loss between 1990 and 2021 was included. To assess the health-related quality of life and return to work and satisfaction, a cross-sectional survey was performed using the short-form-36, lower extremity functional scale, and a self-made questionnaire including the DN4, satisfaction, and subjective ankle function., Results: The median bone defect size was 8 cm (IQR 9-7 cm). The mental component scores were comparable to the Dutch population norm, whereas the impaired physical function scores were associated with pain (r 0.849, p < 0.001). Neuropathic symptoms were reported in 7 out of 19 patients, and 11 out of 19 patients returned to normal daily activity. All respondents reported positive or neutral scores on overall satisfaction with the recovery. Bone healing was uneventful in 19 out of 29 patients. Union was achieved in 25 out of 29 patients. Persistent nonunion was observed in 4 patients, leading to amputation in 2 patients., Conclusion: Vascularized fibula graft use led to high union rates and limb salvage in patients with post-traumatic segmental bone loss of the tibia and femur. Patient satisfaction with the overall recovery was positive; however, functional outcomes remained impaired., (Copyright © 2024 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)
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- 2024
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44. Item response theory validation of the Oxford knee score and Activity and Participation Questionnaire: a step toward a common metric.
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Khatri C, Harrison CJ, MacDonald D, Clement N, Scott CEH, Metcalfe AJ, and Rodrigues JN
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- Humans, Male, Female, Aged, Surveys and Questionnaires standards, Middle Aged, Factor Analysis, Statistical, Reproducibility of Results, Psychometrics, Osteoarthritis, Knee surgery, Arthroplasty, Replacement, Knee, Patient Reported Outcome Measures
- Abstract
Objectives: The Oxford knee score (OKS) and OKS Activity and Participation Questionnaire (OKS-APQ) are patient-reported outcome measures used to assess people undergoing knee replacement surgery. They have not explicitly been tested for unidimensionality (whether they measure one underlying trait such as 'knee health'). This study applied item response theory (IRT) to improve the validity of the instruments to optimize for ongoing use., Study Design and Setting: Participants undergoing primary total knee replacement (TKR) provided preoperative and postoperative responses for OKS and OKS-APQ. Confirmatory factor analysis (CFA) were performed on the OKS and OKS-APQ separately and then on both when pooled into one. An IRT model was fitted to the data., Results: 2972 individual response patterns were analyzed. CFA demonstrated that when combining OKS and OKS-APQ as one instrument, they measure one latent health trait. A user-friendly, free-to-use, web app has been developed to allow clinicians to upload raw data and instantly receive IRT scores., Conclusions: The OKS and OKS-APQ can be combined to use effectively as a single instrument (producing a single score). For the separate OKS and OKS-APQ the original items and response options can continue to be posed to patients, and this study has confirmed the suitability of IRT-weighted scoring. Applying IRT to existing responses converts traditional sum scores into continuous measurements with greater granularity, including individual measurement error., Competing Interests: Declaration of competing interest Chetan Khatri received a salary as a clinical research fellow as a part of the RACER Knee trial (Award ID: NIHR128768). As a part of the RACER Knee trial, Stryker, a medical device company, fund some treatment costs and imaging costs. This manuscript received no funding from Stryker. The independence of the research is protected by legal agreements and have no bearing on the presented study. Nick Clement reports that he is an Editorial board member of the (i) Bone and Joint Journal and (ii) Bone and Joint Research. Chloe Scott reports consulting fees from Smith and Nephew. In addition, she reports payment for delivering educational courses for Stryker and DePuy. She is a part of an advisory board for Pfizer. Andrew Metcalfe reports no conflicts of interest relevant to the current study. He is Chief Investigator for the RACER trial. He is an investigator on three National Institute for Health and Care Research (NIHR)-funded trials (Chief Investigator for START:REACTS and RACER-Knee and co-investigator for RACER-Hip), for which Stryker, a medical device company, fund some treatment costs and some imaging costs. For all these studies, the full independence of the study team is protected by legal agreements, and they have no bearing on the presented study. Conrad Harrison, Deborah MacDonald and Jeremy Rodrigues report no declarations or conflict of interests., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2024
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45. Assessment of health-related quality of life in patients with nontuberculous mycobacterial pulmonary disease: A comprehensive review.
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Kawahara K, Tabusadani M, Ohta K, and Morimoto K
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- Humans, Patient Reported Outcome Measures, Lung Diseases microbiology, Prognosis, Recurrence, Quality of Life, Mycobacterium Infections, Nontuberculous
- Abstract
The global incidence of nontuberculous mycobacterial pulmonary disease (NTM-PD) is increasing. The primary aim of pharmacotherapeutic treatment for NTM-PD is to achieve negative bacterial conversion, but this goal is challenging, especially in cases with poor prognosis factors. Moreover, recurrence frequently occurs following successful treatment. Consequently, patient-reported outcomes (PROs) have attracted an increasing amount of attention due to their potential to elucidate the pathophysiology of NTM-PD. The current review article aimed to describe the current understanding of PROs related to health-related quality of life (HRQoL). HRQoL is influenced by a variety of factors; notably, those factors associated with the prognosis of NTM-PD significantly impair HRQoL. In patients with refractory NTM-PD, HRQoL tends to worsen over time. Assessing HRQoL through PROs involves short-term or long-term evaluation tools, which are selected based on their relevance to the patient's condition and the clinician's goals. Understanding the nuances of PROs can be helpful for delivering empathetic care tailored to patients in even the most complex treatment scenarios., Competing Interests: Declaration of competing interest Kozo Morimoto received an honorarium for consulting fees and an educational lecture from Insmed G.K. The other authors have no conflict of interest., (Copyright © 2024 [The Author]. Published by Elsevier B.V. All rights reserved.)
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- 2024
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46. Cough severity visual analog scale scores and quality of life in patients with refractory or unexplained chronic cough.
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Domingo C, Quirce S, Dávila I, Crespo-Lessman A, Arismendi E, De Diego A, González-Barcala FJ, Pérez de Llano L, Cea-Calvo L, Sánchez-Jareño M, López-Cotarelo P, and Puente-Maestu L
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- Humans, Chronic Disease, Male, Female, Middle Aged, Surveys and Questionnaires, Aged, Adult, Patient Reported Outcome Measures, Chronic Cough, Cough psychology, Quality of Life, Severity of Illness Index, Visual Analog Scale
- Abstract
Background: Refractory chronic cough (RCC) and unexplained chronic cough (UCC) adversely affect patients' quality of life (QoL). This multicenter, non-interventional study evaluates the relationship between cough severity and QoL and other patient-reported outcomes (PROs) in Spanish outpatients., Methods: RCC/UCC patients self-administered a printed survey comprising the cough-severity visual analog scale (VAS), adapted Cough Severity Diary (CSD), and Leicester Cough Questionnaire (LCQ), plus purpose-designed items regarding the physical and everyday-life impact of cough. Patients were stratified into VAS score tertiles. The impact of cough on QoL and other PROs in each tertile, and relationships between LCQ scores and the tertiles, were assessed., Results: The VAS was completed by 189 patients, and VAS score tertiles were identified as 0-50, 60-70, and 80-100 mm. The only between-tertile difference in demographic or cough characteristics was cough duration. VAS score tertiles were linearly associated with mean LCQ domain and total scores, as well as the proportion of patients with the highest scores on all adapted CSD items, and almost all physical and everyday-life impact items. In multiple linear-regression models, an increase of one tertile in the VAS score was associated with a decrease of 2.23 points in the LCQ total score, indicating poorer cough-related QoL., Conclusion: As self-assessed in patients with RCC/UCC, cough-severity VAS scores were strongly associated with the impact of cough on QoL and everyday life. Patients with VAS scores of 60-100 mm reported the greatest impact and thus may benefit the most from targeted cough therapies., Competing Interests: Declaration of competing interest Christian Domingo has received consultant and speaker's honoraria from MSD, Novartis, Boehringer, Sanofi, TEVA, AstraZeneca, ALK, Allergy Therapeutics. Santiago Quirce has received speaking, lecture and consulting fees from Allergy Therapeutics, AstraZeneca, GSK, Mundipharma, Novartis, Sanofi, and Teva. Ignacio Dávila has received consulting fees from Allergy Therapeutics, AstraZeneca, GSK, MSD, Novartis, and Sanofi. Lectures for Allergy Therapeutics, AstraZeneca, Chiesi, Diater, GSK, LETI, Novartis, and Sanofi. Grants to his institution from ISCIII (public entity), Junta de Castilla de León (public entity), and ThermoFisher. Astrid Crespo-Lessman has received consultant's honoraria from AstraZeneca, Sanofi, GlaxoSmithKline, and her institution has received grants from AstraZeneca and GlaxoSmithKline. Luis Puente-Maestu declares no conflict of interest. Ebymar Arismendi declares no conflict of interest. Alfredo De Diego declares no conflict of interest. Francisco Javier González-Barcala has received consulting fees and speaker's honoraria from ALK, AstraZeneca, Bial, Chiesi, GebroPharma, GlaxoSmithKline, Menarini, Novartis, Rovi, Roxall, Sanofi, Stallergenes-Greer and Teva. Luis Pérez De Llano has received consulting fees and speaker's honoraria from AstraZeneca, Chiesi, GlaxoSmithKline, FAES, MSD, Sanofi, Techdow Pharma and Teva, and his institution has received grants from AstraZeneca, FAES and Sanofi. Luis Cea-Calvo, Marta Sánchez-Jareño, and Pilar López-Cotarelo are full-time employees of MSD Spain. Assessed using an 11-point Likert scale, where higher numbers indicate greater severity/impact. Results pertain to the day before the study visit. Not all patients responded to all items. The total number of respondents is specified for each item. Percentages in each cough-severity VAS tertile are calculated based on the number of respondents in that tertile., (Copyright © 2024 [The Author]. Published by Elsevier B.V. All rights reserved.)
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- 2024
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47. Comparative Analysis of Radial Corrective Osteotomy and Sauvé-Kapandji Procedure for Malunited Distal Radius Fractures in Older Adults.
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Wang L, Huang Z, Xie W, Luo D, Liu H, Lian K, and Lin D
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- Humans, Male, Female, Aged, Middle Aged, Fracture Fixation, Internal methods, Disability Evaluation, Pain Measurement, Patient Reported Outcome Measures, Operative Time, Wrist Fractures, Osteotomy methods, Fractures, Malunited surgery, Fractures, Malunited diagnostic imaging, Radius Fractures surgery, Hand Strength, Range of Motion, Articular
- Abstract
Purpose: Malunited distal radius fractures frequently occur in the older population, posing a dilemma in selecting ideal management for symptomatic patients. Radial corrective osteotomy (RCO) and the Sauvé-Kapandji procedure (SK) have been used to treat this challenging condition. However, it remains unknown which approach is better for the older population. The objective of this study was to compare the outcomes of RCO with those of SK for the treatment of symptomatic distal radius malunion in older adults., Methods: Thirty-three patients aged ≥60 years, with malunited distal radius fractures, were randomized to be treated with either RCO or SK and followed for a minimum of 2 years. The primary evaluation parameter was grip strength, and secondary outcome parameters were surgical time, range of motion of the wrist, exercise-related wrist pain assessment using visual analog scale scores, radiographic results, patient-reported outcomes evaluated using the Disability of the Arm, Shoulder, and Hand (DASH), and Patient-Related Wrist Evaluation (PRWE) scores., Results: The average follow-up duration was 36.7 ± 10.2 months. The grip strength was significantly higher in the RCO group. The surgical time was shorter in the SK group than in the RCO group. The postoperative wrist range of motion and visual analog scale scores for exercise-related pain alleviation were similar in both groups. The ulnar variance decreased in both groups and was similar when compared with the postoperative images. The DASH and PRWE scores were similar between the RCO and SK groups., Conclusions: Radial corrective osteotomy and SK surgeries have similar clinical and functional outcomes in patients aged ≥60 years. Grip strength is higher in the RCO group than in the SK group. However, the operating time to accomplish SK is shorter than RCO., Type of Study/level of Evidence: Therapeutic II., Competing Interests: Conflicts of Interest No benefits in any form have been received or will be received related directly to this article., (Copyright © 2024 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.)
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- 2024
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48. When Are You Recovered? Defining Cutoff Points Using the Acute Respiratory Tract Infection Questionnaire.
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Johansen E, Siersma V, Hansen MP, and Aabenhus RM
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- Humans, Female, Male, Middle Aged, Surveys and Questionnaires, Adult, Acute Disease, Aged, ROC Curve, Respiratory Tract Infections diagnosis, Patient Reported Outcome Measures
- Abstract
Objectives: Acute respiratory tract infections (ARTIs) are a heterogenous group of diseases. Often, it is difficult to obtain a precise diagnosis in general practice but also difficult to determine when the patient is recovered. The lack of a precise definition of recovery after ARTI complicates scientific research aiming to optimize diagnostics and compare treatments. The study aimed to define cutoff points to determine the end of an ARTI as a proxy for recovery in patients diagnosed with ARTI in general practice using a validated patient-reported outcome instrument; The ARTI Questionnaire (ARTIQ)., Methods: A total of 259 participants was divided in 2 groups-1 with ARTI and 1 without. Histograms and area under the curve were calculated for each of the 5 dimensions within the ARTIQ to evaluate the discriminative effect. For the most discriminative dimensions receiver operating comparison curves were performed to determine relevant cutoff points for having or not having ARTI symptoms and serve as a proxy for recovery in clinical research., Results: The highest discriminative effect was found in 2 dimensions: "physical-upper airways" and "physical-lower airways." When combining these dimensions, the area under the curve was 0.97. Sensitivity, specificity, and predictive values were calculated for selected cutoff points., Conclusion: Cutoff points serving as proxy for recovery from ARTI using a patient-reported outcome were identified. The specific cutoff point for a certain research project must be selected considering the specific clinical situation of interest., Competing Interests: Author Disclosures Author disclosure forms can be accessed below in the Supplemental Material section., (Copyright © 2024. Published by Elsevier Inc.)
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- 2024
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49. Monitoring what matters to people with diabetes: Do we underestimate the importance of behaviour, attitude, and well-being?
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Porth AK, Seidler Y, Long PA, Huberts AS, Hamilton K, Stamm T, and Kautzky-Willer A
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- Humans, Female, Male, Middle Aged, Adult, Self-Management, Health Behavior, Self Care, Aged, Patient Reported Outcome Measures, Patient Preference, Surveys and Questionnaires, Patient-Centered Care, Diabetes Mellitus therapy, Diabetes Mellitus psychology, Delphi Technique
- Abstract
Objective: Despite improvements in diabetes monitoring and treatment many patients do not achieve treatment goals. Person-centred approaches have been proposed. However, their practical implementation lags. One barrier is uncertainty about which person-reported outcomes (PROs) should be considered to add the most value. We sought to identify PROs that may be prioritised., Methods: We used data from a multi-stakeholder Delphi study aimed at developing a person-centred diabetes outcome set and analysed which PROs patients considered important for regular monitoring but healthcare providers less so. Linear regression analyses tested whether belonging to either stakeholder group would predict the importance attributed to an outcome., Results: We found disagreement between patients and healthcare providers on eleven PROs. Stakeholder group predicted perceived importance for ten: self-management behaviours (including performance, perceived importance, motivation, and capacity), sleep quality, diabetes symptoms, screening visit attendance, health status, lifestyle behaviours, and side effects., Conclusion: Our findings suggest that, according to patients' preferences, self-management behaviours, health status and sleep are currently not adequately considered in diabetes management, compromising person-centred care., Practical Implications: This study suggests that prioritising these PROs can facilitate the implementation of more person-centred diabetes monitoring which may support better-informed treatment decisions to achieve treatment goals., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)
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- 2024
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50. Patient-reported symptomatic events do not adequately reflect atrial arrhythmia.
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Abedin Z, Herner M, Torre M, Zhang Y, Orton C, Lyons A, Bunch TJ, and Steinberg BA
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- Humans, Female, Male, Middle Aged, Retrospective Studies, Aged, Heart Rate physiology, Patient Reported Outcome Measures, Tachycardia, Supraventricular diagnosis, Tachycardia, Supraventricular physiopathology, Follow-Up Studies, Atrial Fibrillation physiopathology, Atrial Fibrillation diagnosis, Electrocardiography, Ambulatory methods
- Abstract
Background: Management of atrial fibrillation is frequently geared toward improving symptoms. Yet, the magnitude of symptom-rhythm discordance is not well known in the setting of monitoring by ambulatory electrocardiography (AECG)., Objective: We aimed to quantify the symptom-rhythm correlation (SRC) for atrial arrhythmia (atrial tachycardia/atrial fibrillation [AT/AF]) events., Methods: This was a retrospective cohort analysis of AECG data at a tertiary care center. All AECGs of ≥7 days with at least 1 AT/AF were included. Patient-triggered symptoms included shortness of breath, tiredness, palpitations, dizziness, or passing out with or without concurrent AT/AF. SRC was calculated for each patient. In addition, AT/AF-symptom association was evaluated at the event level by multivariable mixed effects logistic regression., Results: We identified 742 patients with qualifying AECG data; mean age was 64 years, 50% were female, and 22% had heart failure. The mean CHA
2 DS2 -VASc score was 2.5. There were 6289 symptomatic events and 6900 AT/AF episodes. Of symptomatic events, 1013 (16%) had shortness of breath, 839 (13%) tiredness, 2640 (42%) palpitations, 783 (12%) dizziness, and 93 (1%) passing out. Overall SRC was 0.39 (range, 0-1.0), but presence of AT/AF increased odds of symptoms by ∼8.3 times in adjusted analyses (P < .01). In multivariable analysis, prior AF rhythm control treatment and lower heart rate were associated with worse SRC (P < .01)., Conclusion: Whereas AT/AF events increase the chances of symptoms, there is poor overall correlation between symptomatic events and documented AT/AF. Patient factors and prior treatments influence SRC. An improved understanding of this relationship correlation is needed to optimize clinical outcomes and to improve the rigor of AF research., Competing Interests: Disclosures B.S. reports research support from Abbott, Cardiva, Sanofi, and AltaThera; and consulting to Sanofi, InCarda, Milestone, Pfizer, and AltaThera. The remaining authors do not report any relevant disclosures., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)- Published
- 2024
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