Standardized Patient-reported Outcome Research Articles

Developing the EPI Symptom Questionnaire (EPI-SQ): a qualitative study to understand the symptom experience of patients with exocrine pancreatic insufficiency (EPI)

BackgroundSymptom assessment is the key factor in determining disease status and optimal management of exocrine pancreatic insufficiency (EPI). There is a need for a standardized patient-reported outcome (PRO) questionnaire to assess symptoms in patients diagnosed with EPI. The purpose of this qualitative study was to increase understanding of the EPI symptom experience from the patients’ perspective, and to develop and evaluate the content validity of the EPI Symptom Questionnaire (EPI-SQ) in US patients with EPI.MethodsConcept elicitation interviews (Phase I) were conducted to understand the symptom experience in patients with a clinical diagnosis of EPI (i.e., fecal pancreatic elastase value of ≤ 200 mcg/g based on most recent value) due to chronic pancreatitis or pancreatectomy. The EPI-SQ was developed based on the data extracted from Phase I interviews and feedback from clinical experts. Next, separate cognitive interviews (Phase II) were conducted to evaluate participants’ understanding of the instructions, items, response scales, and recall periods of the instrument.ResultsDuring Phase I interviews (n = 21), 19 participants (90%) reported abdominal pain as the most frequent EPI symptom and lifestyle changes were the most frequently endorsed impacts (n = 18; 86%). Phase II results indicated that all participants (n = 7) felt the 12-item EPI-SQ was relevant to their symptom experience and that they understood the items, instructions, and response options as intended.ConclusionThe qualitative data from this study support the content validity of the EPI-SQ in measuring EPI symptom severity in US patient populations diagnosed with EPI.

Validation and correlations of the Angioedema Activity Score (AAS), Angioedema Quality of Life (AE-QoL) questionnaire, and Angioedema Control Test (AECT) in Chinese patients with angioedema

BackgroundThe impact of recurrent angioedema can be severely debilitating and remains difficult to quantify. Several standardized patient-reported outcome measures (PROMs), including the Angioedema Activity Score (AAS), Angioedema Quality of Life Questionnaire (AE-QoL) and Angioedema Control Test (AECT), have been developed and translated into different languages. However, these PROMs have yet to be validated in Chinese and their correlations in the Chinese population remain unknown. ObjectiveTo validate the Chinese AAS, AE-QoL, and AECT and to assess their inter-correlations. MethodsA prospective cohort of 118 Chinese patients with recurrent angioedema at the Angioedema and Urticaria Centre of Reference and Excellence in Hong Kong completed the traditional Chinese versions of the AAS, AE-QoL, and AECT. We analysed the reliability and validity of these PROMs and their correlations with each other and with generic PROMs. ResultsThe Chinese AAS, AE-QoL and AECT demonstrated excellent internal consistency (Cronbach’s α: 0.920, 0.976, and 0.832; McDonald’s ω: 0.972, 0.977, and 0.901; respectively). Confirmatory factor analysis for the AE-QoL showed an acceptable fit to the 4-dimensional model (comparative fit index=0.869, Tucker–Lewis’s index=0.842). The AECT showed significant correlations with both the AAS and AE-QoL (ρ=-0.750 and -0.456 respectively, both p<0.05). The AE-QoL moderately correlated with certain domains of generic PROMs such as WPAI-GH V2.0 and SF-12v2 (all ρ<0.60). ConclusionThe Chinese AE-QoL, AAS, and AECT are valid and reliable tools for Chinese patients. More validated tools should be made available to improve patient care and research for all angioedema patients globally.

Mass General Brigham’s Patient-Reported Outcomes Measurement System: A Decade of Learnings

This article describes the strategies that leaders at the Mass General Brigham (MGB) health system have used in launching a standardized patient-reported outcome measure (PROM) collection program in 2012, a major step in the value-based transformation of health care. This article documents many benefits to patients, clinicians, and payers from the effective design, collection, and use of PROMs. These benefits include shared decision-making aligned to patients’ goals; improving patient expectations about their likely experiences and outcomes from treatment; empowering patients to self-monitor during recovery; facilitating communication between physicians and patients about what matters most to patients; enhancing treatment by having PROMs embedded in the patients’ electronic health record; and reducing disparities in access, treatment, and outcomes for previously underserved racial and ethnic groups. For payers, PROMs allow payments to be based on patient outcomes. By continuously answering each stakeholder’s “what’s in it for me” question, MGB has taken an important step toward building a learning health system to equitably achieve health outcomes that align with patients’ goals for their health. Working together, the MGB PROMs Program and the Brigham and Women’s Hospital’s Patient-Reported Outcomes, Value, and Experience Center, a transdisciplinary PROMs research hub, plan to continue their efforts to improve and expand the use of PROMs to accelerate the shift toward accountable, patient-centered care.

A Health-Related Quality of Life Measure for Patients Who Undergo Minimally Invasive Glaucoma Surgery

PurposeTo develop a standardized patient-reported outcome measure to assess the impact of glaucoma and treatment, including minimally invasive glaucoma surgery (MIGS), on health-related quality of life (HRQOL). DesignObservational study before and after concomitant cataract and FDA-approved implantable MIGS device surgery to provide information on the measure's performance in assessing HRQOL. Methods SettingSurvey administration was done by electronic patient-reported outcomes (ePRO) application to patients at multiple sites on a computer, iPad, or similar device. Patient PopulationOne hundred eighty-four adults completed a baseline survey, 124 completed a survey 3 months after surgery, and 106 completed the 1-month test-retest reliability survey. The age range was 37-89, and the average age was 72. Most of the respondents were female (57%), non-Hispanic White (81%), and had a college degree (56%). Main Outcome MeasuresThe Glaucoma Outcomes Survey (GOS) includes 42 questions assessing functional limitations (27 items), vision-related symptoms (7 items), psychosocial issues (7 items) and satisfaction with microinvasive glaucoma surgery (1 item). The three multiple-item scales were scored on a 0-100 range, with a higher score indicating worse health. ResultsInternal consistency reliability estimates ranged from 0.75 (vision-related symptoms) to 0.93 (functional limitations) and one-month test-retest intraclass correlations ranged from 0.65 (PROMIS global mental health) to 0.92 (functional limitations). Product-moment correlations among the GOS scales ranged from 0.56 to 0.60. Improvement in visual acuity in the study eye from baseline to the 3-month follow-up was significantly related to improvements in GOS functional limitations (r =0.18, p =0.0485), vision-related symptoms (r = 0.19, p = 0.0386), and psychosocial concerns (r = 0.18, p =0.0503). The highest proportion of responders to treatment was seen for the GOS functional limitations scale (48%), followed by GOS psychosocial issues (21%) and GOS vision-related symptoms (17%). ConclusionsThis study provides initial support for using the GOS instrument in ophthalmic procedures such as MIGS. Further evaluation of the GOS in other samples, including different patient subgroups and clinical settings, will be valuable. The instrument may be useful for evaluations of other treatments for glaucoma.

Oral Irrigation Devices: A Scoping Review.

Self-performed oral hygiene is essential for preventing dental caries, periodontal, and peri-implant diseases. Oral irrigators are adjunctive oral home care aids that may benefit oral health. However, the effects of oral irrigation on oral health, its role in oral home care, and its mechanism of action are not fully understood. A comprehensive search of the literature revealed no existing broad scoping reviews on oral irrigators. Therefore, this study aimed to provide a comprehensive systematic review of the literature on oral irrigation devices and identify evidence gaps. The Joanna Briggs Institute and Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews guidelines were utilized to prepare the review. Four databases and eight gray literature sources were searched for English publications across any geographical location or setting. Two hundred and seventy-five sources were included, predominantly from scientific journals and academic settings. Most studies originated from North America. Research primarily involved adults, with limited studies in children and adolescents. Oral irrigation was safe and well-accepted when used appropriately. It reduced periodontal inflammation, potentially by modulating the oral microbiota, but further research needs to clarify its mechanism of action. Promising results were reported in populations with dental implants and special needs. Patient acceptance appeared high, but standardized patient-reported outcome measures were rarely used. Anti-inflammatory benefits occurred consistently across populations and irrigant solutions. Plaque reduction findings were mixed, potentially reflecting differences in study designs and devices. Oral irrigators reduce periodontal inflammation, but their impact on plaque removal remains unclear. Well-designed, sufficiently powered trials of appropriate duration need to assess the clinical, microbiological, and inflammatory responses of the periodontium to oral irrigation, particularly those with periodontitis, dental implants, and special needs. Patient-reported outcome measures, costs, caries prevention, and environmental impact of oral irrigation need to be compared to other oral hygiene aids.

Feasibility and utilization of electronic patient-reported outcome measures for lung cancer in routine clinical care.

11107 Background: Prior studies have shown the value of Patient-Reported Outcomes (PRO) in cost burden, quality of life (QoL), and survival in cancer care. To facilitate focus on patient-centricity and value-based care, the International Consortium for Health Outcomes Measurements (ICHOM) and European Health Outcomes Observatory (H2O) developed a Core Outcomes Set (COS) in lung cancer. We explored the feasibility of deploying standardized PRO measures among patients with lung cancer in US clinical practice. Methods: A retrospective database study was conducted, with IRB waiver, using Carevive PROmPT, an electronic PRO (ePRO) remote symptom monitoring platform with weekly surveys comparable in scope to ICHOM/H2O COS, of symptomatic adverse events (PRO-CTCAE), physical function (PROMIS 4A Physical Function), and QoL items (EORTC QLQ-C30 items #29,30). Severe PRO-CTCAE symptom scores triggered care team alerts. From 9/2020 to 5/2023, 207 patients enrolled across 9 US cancer centers. Patients were ≥18 years, with lung cancer, and in current treatment. Patient engagement was measured by survey compliance, follow-up time, and completeness; clinician engagement was measured by platform utilization time, time to alert response, and clinical action taken. Results: Participants were 50% female, 86% White, 12% African American, median age 68, 81% NSCLC, and 26% with metastatic disease. Median survey persistence: 8 weeks, with 85% compliance over that time. Of domains assessed, 37 (58%) from Carevive data overlapped with ICHOM/H2O COS, with 19 measured over time. Overlapping domains included 15 clinical outcomes with 60% median completion rate and 22 PRO domains with 98% median completion. Of 19 domains assessed longitudinally, median compliance was 76%. Of patients triggering ≥1 ePRO symptom alert, 87% were within 4 weeks, with 46% requesting call-backs. Median clinician follow-up to alerts was 20 hours, with 69.3% addressed within 48 hours. Clinicians accessed the platform 2-3 times weekly, for median 2 minutes (range: 1-14 minutes) per login for nurses and Advanced Practitioners (AP). 89% of alerts were addressed by nurses and AP. Of alert responses, 66% indicated continuation of treatment, 12% were escalated to the clinical team, and 1% were escalated to hospitalization or ER visit. Conclusions: Results support the feasibility of integrating a standard set of multi-domain ePRO measures, comparable to the ICHOM/H2O COS, into routine cancer care, across multiple sites, with consistent patient engagement and provider utilization. One limitation is that clinical and financial impact were not directly assessed. Future research should explore direct clinician feedback, systematic implementation of PRO measures, and impacts on patient outcomes, resource utilization, and health systems.

Immunotherapy related patient-reported outcomes from five randomized controlled trials in patients with triple negative breast cancer: A systematic review.

e23167 Background: Immunotherapy (IO) has improved clinical outcomes in patients with early-stage Triple Negative Breast Cancer (TNBC) receiving neoadjuvant therapy and certain patient subsets in the metastatic setting. This study aims to evaluate IO-related Patient-Reported Outcomes (PRO) in patients older than 65 years. Methods: We searched Medline ALL (Ovid), Embase (Elsevier), Cochrane Central (Wiley), ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform. The searches combined terms reflecting (1) the immune checkpoint inhibitors atezolizumab, durvalumab, and pembrolizumab; (2) breast cancer; and (3) randomized controlled trials. Results were limited to items published in English from 2013 through September 2023. We excluded review articles and clinical trial records without results. Two independent reviewers (C.S. and M.L.) screened the studies using the systematic review management tool Covidence, and conflicts were resolved by a third reviewer (W.I.Z.). We included studies that reported on PRO in adults with TNBC receiving any of the three immunotherapies of interest. Results: Five publications composed of two peer-reviewed papers and three abstracts were identified, including 3878 total patients and 3184 with PRO. Three pembrolizumab studies had 2643 total patients (2056 with PRO) and two atezolizumab studies (IMPASSION 130, IMPASSION 031) had 1235 total patients (1128 with PRO). The PRO analysis in KEYNOTE 522 included 1145 patients in the neoadjuvant phase and 847 in the adjuvant phase. The PRO analysis in KEYNOTE 355 included total 847 patients and 317 with Combined Positive Score (CPS) ≥10. No study specified PRO data for patients older than 65 years. Baseline completion rates for all studies were &gt; 80%. All studies used standardized PRO instruments, including the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC- QLQ C30) and its Breast Cancer Module (QLQ-BR23), the Functional Assessment of Cancer-Therapy-General (FACT-G GP5), and the EuroQol-5 Dimension (EQ-D5). All studies showed no statistical difference, or clinical meaningful decline in PRO endpoints between patients who received chemo with IO versus chemo with placebo, during and post treatment follow up. The PRO analysis from KEYNOTE 119, which included total 594 patients of which 187 had CPS ≥10, demonstrated that patients receiving single agent chemotherapy had worse PROs related to systemic therapy side effects and hair loss while the pembrolizumab group had decreased worry about future health. None included subgroup analysis by age, including patients older than 65 years. Conclusions: Our systematic review demonstrates that in both early and advanced TNBC, IO did not worsen PRO. Prospective and retrospective data in IO-related PRO in older patient population are needed.

Crosswalk between the PROMIS physical function CAT and PROMIS upper extremity CAT v1.2 in a hand surgery population

BackgroundThere is no gold standard patient-reported outcome measure (PROM) in hand surgery. As a result, a diverse array of PROM instruments have been utilized across centers over time. Lack of score interchangeability limits the ability to compare or conglomerate scores when new instruments are introduced. Our aim was to develop a linkage for the PROMIS UE CAT v1.2 and PROMIS PF CAT scores and develop crosswalk tables for interconversion between these PROMs.MethodsRetrospective review was conducted to identify adult (≥ 18y) patients seen by orthopaedic hand surgeons at a single academic tertiary care hospital who had completed PROMIS UE CAT v1.2 and PROMIS PF CAT score at the same visit. For those with multiple visits, only one randomly selected visit was included in the analyses. Pearson’s correlation was calculated to determine the linear relationship between the scores. Linkage from PF to UE was performed utilizing several commonly utilized equating models (identity, mean, linear, equipercentile and circle-arc methods). The performance of the models was assessed using intraclass correlation (ICC) between observed PROMIS UE CAT v1.2 and estimated PROMIS UE CAT v1.2 scores generated using the model as well as Root Mean Square Error (RMSE). The model chosen as the ‘best’ was further assessed for population invariance using root expected mean squared difference (REMSD) where < 0.08 were considered good.ResultsOf 10,081 included patients, mean age was 48.3 (SD = 17.0), and 54% were female (5,477/10,081). Mean UE CAT v1.2 and PF CAT scores were 37 (SD = 9.8) and 46 (SD = 10.0), respectively. There was a strong correlation between the scores (Pearson correlation r = 0.70). All methods performed acceptably (ICC ≥ 0.66 and RMSE < = 7.52 for all). The equipercentile method had the highest ICC (ICC = 0.70 (95% CI 0.69–0.71)) while the mean and circle arc methods had the lowest RMSE. The circle arc method is the most reliable with the smallest standard error and has satisfactory population invariance across age group (REMSD 0.065) and sex (REMSD 0.036).ConclusionsCrosswalk tables to be used for bidirectional conversion between scores were created.Level of evidence: III.

The use of actigraphy to objectively define motion and function before and after shoulder arthroplasty

IntroductionActigraphy is a quantitative means of measuring activity data that has proven viable in post-surgery recovery analysis for arthroplasties in lower extremities, but scant literature has been published on the utilization actigraphy to evaluate shoulder motion and function before and after shoulder arthroplasty. The purpose of this prospective cohort study is to identify if actigraphy can serve as a valid means for objective evaluation of shoulder function and motion before and after shoulder arthroplasty. Secondarily, the data collected by the actigraphy can be analyzed with standard patient-reported outcomes to report correlations between the subjective and objective methods used in this study. Materials and methodsSixty-four subjects wore an actigraphy device for one day at pre-op, six, twelve and twenty-four weeks. In addition, subjects completed three patient-reported outcome surveys at each time-point. Student t-tests were used to compare percent activity preoperatively with 24-weeks and to compare PROs preoperatively with 24-week results; categorical variables were compared with one-way ANOVAs. ResultsAll Patient reported outcome scores significantly improved following arthroplasty (p-value<0.001). The percent of physical activity was highly correlated with vector magnitude (p-value<0.001), but neither percent activity or the vector magnitude were correlated with any of the PROs: UCLA Pain p-value = 0.656, SANE p-value = 0.328, UCLA Function p-value = 0.532. ConclusionsActigraphy results from this study mirror findings in previous literature utilizing the technology in similar manners and demonstrate its potential for motion and function analysis before and after total shoulder arthroplasties. Despite both being suitable methods independently for the evaluation of shoulder function, there was no significant correlation between standard actigraphy measurements and PROs at 24-weeks. Future research to determine clinical utility and an overall broader scope for actigraphy monitoring could benefit from improved technology, such as increased battery life for prolonged durations of data collection during observation periods.

The Effect of Spacer Treatment of Infected Hip and Knee Arthroplasties on Patients' Mental Health: A Narrative Review of the Literature.

The gold standard treatment for periprosthetic joint infections is the two-stage revision that includes the spacer placement before definitive reimplantation. The management of PJI affects patients' joint function and, subsequently, their mental health. Even though significant advances have been achieved, little to no attention has been paid to the psychological implications. So, based on standardized patient-reported outcome measures (PROMs), this study aimed to clarify the effect of spacer treatment of infected hip and knee arthroplasties on patients' mental health. We performed research on the literature on PJIs in the English language using the MEDLINE database with the search strings "spacer" OR "spacers" AND "hip" OR "knee" AND "SF-12" OR "SF-36" OR "EQ-5" OR "mental" OR "depression" OR "anxiety." The reference lists of selected articles were also hand-searched for any additional articles. A total of 973 published papers were extracted, and 9 papers were finally included. A total of 384 patients who underwent spacer placement for PJI were identified. Of these 384 patients, 54% were female. The mean age ranged from 62 to 78.2 years. Of the11 papers identified for this review, 4 analyzed only hip spacers, including 119 patients; 4 only knee spacers, evaluating 153 patients; while a single study included 112 patients for both joints. Patients with the spacer are living in a state of mental upset, albeit better than the preoperative state. Clinical improvement with the review is not assured. The alteration of mental state turns out not to be transient for all the patients.

Hierarchical Clustering Applied to Chronic Pain Drawings Identifies Undiagnosed Fibromyalgia: Implications for Busy Clinical Practice

Currently-used assessments for fibromyalgia require clinicians to suspect a fibromyalgia diagnosis, a process susceptible to unintentional bias. Automated assessments of standard patient-reported outcomes (PROs) could be used to prompt formal assessments, potentially reducing bias. We sought to determine whether hierarchical clustering of patient-reported pain distribution on digital body map drawings predicted fibromyalgia diagnosis. Using an observational cohort from the University of Pittsburgh’s Patient Outcomes Repository for Treatment registry, which contains PROs and electronic medical record data from 21,423 patients (March 17, 2016–June 25, 2019) presenting to pain management clinics, we tested the hypothesis that hierarchical clustering subgroup was associated with fibromyalgia diagnosis, as determined by ICD-10 code. Logistic regression revealed a significant relationship between the body map cluster subgroup and fibromyalgia diagnosis. The cluster subgroup with the most body areas selected was the most likely to receive a diagnosis of fibromyalgia when controlling for age, gender, anxiety, and depression. Despite this, more than two-thirds of patients in this cluster lacked a clinical fibromyalgia diagnosis. In an exploratory analysis to better understand this apparent underdiagnosis, we developed and applied proxies of fibromyalgia diagnostic criteria. We found that proxy diagnoses were more common than ICD-10 diagnoses, which may be due to less frequent clinical fibromyalgia diagnosis in men. Overall, we find evidence of fibromyalgia underdiagnosis, likely due to gender bias. Coupling PROs that take seconds to complete, such as a digital pain body map, with machine learning is a promising strategy to reduce bias in fibromyalgia diagnosis and improve patient outcomes. PerspectiveThis investigation applies hierarchical clustering to patient-reported, digital pain body maps, finding an association between body map responses and clinical fibromyalgia diagnosis. Rapid, computer-assisted interpretation of pain body maps would be clinically useful in prompting more detailed assessments for fibromyalgia, potentially reducing gender bias.

Vehicle Headlight Halo Simulation of Presbyopia-Correcting Intraocular Lenses.

This optical bench study was designed to evaluate and compare the halos generated by presbyopia-correcting intraocular lenses (PCIOLs) and monofocal intraocular lenses (IOLs), with or without lens decentration, using an optical bench to simulate the headlight of a distant vehicle in mesopic conditions. Halos generated by six nondiffractive and 10 diffractive IOLs with different dioptric add powers were evaluated using a high dynamic range bench system. Halo intensities were compared by assessing the area under the measured intensity profile curve to compute the relative halo magnitude (RHM). Nondiffractive PCIOLs produced smaller and less intense bench halo images than diffractive ones. RHM measurements ranged from 964 to 1896. Monofocal IOLs produced lower RHM values, whereas diffractive PCIOLs generated higher ones. When decentered by 0.5 mm with respect to the system aperture, more obviously asymmetric halo image profiles were observed in diffractive compared with nondiffractive PCIOLs. Simulated bench halos of nondiffractive PCIOLs are smaller and less intense than those of diffractive PCIOLs. Additional clinical studies assessing standardized patient-reported outcomes measures are required to correlate these bench results with patient satisfaction. This study contrasts the design-related simulated bench halos of nondiffractive and diffractive PCIOLs, aiming to elucidate their impact on halo perception.

Patient-reported quality of life and acceptance of the extravascular implantable cardioverter-defibrillator: Results from pivotal study.

The pivotal study of the extravascular implantable cardioverter-defibrillator (EV ICD) recently demonstrated primary efficacy and safety endpoints comparable to previous ICD systems. Patient experience with this novel device has not been reported. The current study examined the standardized patient-reported outcome (PRO) metrics of quality of life (QOL) and patient acceptance of the device. The EV ICD Pivotal Study was a prospective, single-arm, nonrandomized, global, premarket approval trial. Patients completed the 12-Item Short Form Survey (SF-12) QOL surveys at baseline and at 6 months following implant. Additionally, patients completed the Florida Patient Acceptance Survey (FPAS) QOL survey at 6 months. From baseline to 6 months, patients within the EV ICD Pivotal Study (n = 247) reported statistically significant SF-12 improvements in physical QOL (45.4 ± 9.4 vs. 46.8 ± 9.1 respectively, p = .020) and no changes in mental QOL (49.3 ± 10.4 vs. 50.5 ± 9.7, p = .061). No differences were noted by sex, atrial fibrillation, or the experience of ICD shock. EV ICD patients reported better total FPAS patient acceptance of their ICD than TV-ICD or S-ICD patients using historical norms comparisons (80.4 ± 15.7 vs. 70.2 ± 17.8, p < .0001 for S-ICD and 73.0 ± 17.4, p = .004 for TV-ICD). The initial PROs for EV ICD patients indicated that patients had improvements in physical QOL from baseline to 6-month follow-up and markedly better overall acceptance of their ICD compared to a previous study with S-ICD and TV-ICD data. These initial results suggest that the EV ICD is evaluated positively by patients.

Dysautonomia, but Not Cardiac Dysfunction, Is Common in a Cohort of Individuals with Long COVID.

Despite the prevalence of dysautonomia in people with Long COVID, it is currently unknown whether Long COVID dysautonomia is routinely accompanied by structural or functional cardiac alterations. In this retrospective observational study, the presence of echocardiographic abnormalities was assessed. Left ventricular (LV) chamber sizes were correlated to diagnostic categories and symptoms via standardized patient-reported outcome (PRO) questionnaires. A total of 203 individuals with Long COVID without pre-existing cardiac disease and with available echocardiograms were included (mean age, 45 years; 67% female). Overall, symptoms and PRO scores for fatigue, breathlessness, quality of life, disability, anxiety and depression were not different between those classified with post-COVID dysautonomia (PCD, 22%) and those unclassified (78%). An LV internal diameter at an end-diastole z score < -2 was observed in 33 (16.5%) individuals, and stroke volume (SV) was lower in the PCD vs. unclassified subgroup (51.6 vs. 59.2 mL, 95% C.I. 47.1-56.1 vs. 56.2-62.3). LV end-diastolic volume (mean diff. (95% CI) -13 [-1--26] mL, p = 0.04) and SV (-10 [-1--20] mL, p = 0.03) were smaller in those individuals reporting a reduction in physical activity post-COVID-19 infection, and smaller LVMI was weakly correlated with worse fatigue (r = 0.23, p = 0.02). The majority of individuals with Long COVID report shared symptoms and did not demonstrate cardiac dysfunction on echocardiography.

Treatment Outcomes of Interdisciplinary Care on Speech and Health-Related Quality of Life Outcomes in Adults With Cleft Palate.

Individuals born with a cleft palate with or without a cleft lip (CP ± L) often experience functional, aesthetic, and psychosocial consequences well into adulthood. This study aimed to investigate outcomes of speech and health-related quality of life (HRQoL) in adults with a CP ± L who received interdisciplinary cleft care at the Ghent University Hospital using valid, reliable, and condition-specific instruments. Thirteen Belgian Dutch-speaking participants with a CP ± L with a mean age of 25.4 years (SD = 5.1, range: 20-33 years) and an age- and gender-matched control group of 13 participants without a CP ± L with a mean age of 25.2 years (SD = 4.8, range: 20-32 years) were included in this study. Speech characteristics were evaluated perceptually and instrumentally. HRQoL was assessed through standardized patient-reported outcome measures. Outcomes were compared with those of the control group and to normative data where available. Participants with a CP ± L in this sample demonstrated significantly lower speech acceptability (p < .001) and higher rates of hypernasality (p = .015) and nasal turbulence (p = .005) than the control group. They showed significantly higher satisfaction with appearance of the cleft scar compared with norms of adults with a CP ± L (p = .047). No other differences in speech characteristics, sociodemographics, or HRQoL were found between participants with and without a CP ± L. The reduced speech acceptability and the presence of resonance and nasal airflow disorders may indicate the need for standardized long-term outcome measurement and interdisciplinary follow-up for speech characteristics and velopharyngeal insufficiency in young and middle adulthood in future clinical practice. Additional research is necessary to further substantiate these findings and to determine predictors for these continuing complications in adults with a CP ± L. https://doi.org/10.23641/asha.24243901.

Frequency of standardized patient-reported outcome measures in routine clinical care of patients with cancer.

342 Background: Patient-reported outcomes (PROs) assess a patient’s self-reported health status, including disease symptoms, treatment experience, functional outcomes, and quality of life. Incorporation of PROs has been linked to improved patient symptom control and increased shared decision making. Standardized PRO measures (PROMs) are becoming more frequent as an endpoint for clinical trials, however their use is less frequent in routine care for patients with cancer. The goal of this study was to assess the utilization of PROMs and identify barriers to their use. Methods: US-licensed oncologists/hematologists convened at one of three live meetings in 2023 to review recent clinical updates. Respondent demographics were collected ahead via an online survey. During the meetings, participants responded to queries on their use and perceptions of PROs and PROMs. Responses were captured via audience response system technology; not all participants answered every question. Pooled data were summarized using descriptive statistics. Results: Of the 146 respondents, 77.4% self-identified as community-setting providers, spent 84.3% of their time seeing patients, saw an average of 19.8 patients/day, and averaged 17.7 years of experience. Respondents found PROs to be most useful in early detection/management of treatment toxicities and symptoms (63.8%) and tailoring of clinical/supportive care (56%). The majority of PROs are typically recorded through informal verbal inquiries, while 18.1% and 10.9% of respondents use validated and non-validated PROMs, respectively. Few respondents (11.3%) administer PROMs to every patient at every visit, while over one-third (38.3%) never administer PROMs. Within the practice, medical assistants and nurses are most likely to be the provider administering PROMs. PROMs are most commonly administered when the patient is in the office and are infrequently administered through other means. Lack of time to administer or review PRO surveys (45.1%), and lack of reimbursement (38.9%) and EMR integration (38.9%) were the most common reported barriers to using PROMs in the respondents’ practices. Conclusions: Despite the majority of respondents finding PROs useful in practice, a minority use formal measures to record PROs. Further, usage is infrequent across patient visits. Lack of time, lack of reimbursement, and logistic barriers are the most common reasons for not using PROMs in routine care. These barriers may be overcome by efforts or guideline changes from regulatory agencies, payors, or clinical guideline organizations. Future work will assess how physicians are using PROMs in treatment selection for their patients with cancer.

Effects of high-profile crossover feet on gait biomechanics in 2 individuals with Syme amputation.

Prosthetic treatment options for people with ankle disarticulation (i.e., Syme amputation) are limited. Prosthetic feet designed for people with Syme amputation are often low profile to accommodate build-height restrictions, resulting in decreased energy return during gait. High-profile crossover feet that attach to the posterior proximal aspect of the prosthetic socket can bypass these restrictions and may promote a more physiologic gait pattern. To compare level-ground gait biomechanics and patient-reported outcomes between crossover and traditional energy-storing feet in people with Syme amputation. Within-participant pilot study. Both participants were fit with energy-storing and crossover feet and were randomized to the order they used the feet. Participants used each foot for 2 weeks before assessment. Step length symmetry, prosthetic ankle range of motion, prosthetic-side energy return, and peak sound-side loading were determined from motion capture data obtained in a laboratory. Mobility and balance confidence were measured using standardized patient-reported outcome measures. Foot preference was assessed with an ad hoc survey. Two participants with Syme amputations completed the study. Prosthetic ankle peak dorsiflexion and push-off power increased with the crossover foot compared with the energy-storing foot for both participants. Both participants reported an overall preference of the crossover foot. Changes in patient-reported outcomes did not exceed published minimum detectable change values. Crossover feet increased prosthetic ankle range of motion and energy return compared with traditional energy-storing feet in this pilot investigation of 2 participants. Crossover feet seem to promote physiologic gait and may be a promising alternative to traditional low-profile feet for people with Syme amputation.

Use and Effectiveness of Physical Therapy After Hip Arthroscopy for Femoroacetabular Impingement

Background: Limited literature exists regarding how postoperative physical therapy (PT) may affect outcomes in patients with femoroacetabular impingement syndrome (FAIS) undergoing hip arthroscopy. Additionally, it is unknown how PT measures relate to traditional orthopaedic patient-reported outcomes (PROs). Purpose: To evaluate how the duration of PT may correlate with outcomes in patients with FAIS using both the Lower Extremity Functional Scale (LEFS) and standard orthopaedic PRO measures. Study Design: Cohort study; Level of evidence, 3. Methods: Patients from a single institution who underwent primary hip arthroscopy for FAIS between 2013 and 2016 were identified. Patients with a minimum 2-year follow-up and fully documented PT notes were included and stratified into 3 cohorts based on timing of PT discharge: 0 to 3 months, 3 to 6 months, and 6 to 12 months. Predictive regression models were developed to analyze the rate of improvement (ROI) in LEFS score as it relates to (1) postoperative day (POD) and (2) postoperative PT session number. Two-year PROs were collected, correlated with LEFS scores, and compared among cohorts. Results: A total of 95 patients were included (mean ± SD age, 34.6 ± 11.7 years; range, 14-55 years). Mean LEFS scores increased significantly from the initial score at 6 weeks, 3 months, and the time of PT discharge (P < .01 for all). The predicted ROI in LEFS score was 3.39% per PT session for sessions 0 to 13, 1.43% for sessions 14 to 27, and 0.37% for sessions 28 to 40. Patients who underwent 3 to 6 months of PT had significantly better Hip Outcome Score (HOS) relative to the 0- to 3-month cohort and significantly better visual analog scale (VAS) scores for satisfaction relative to the 6- to 12-month cohort. The predicted ROI in LEFS score was 0.96% per day from POD 0 to 45, 0.22% from POD 46 to 139, and 0.03% after POD 139. Moderate correlations were seen between LEFS score at the time of discharge and all 2-year PROs as follows: HOS Activities of Daily Living subscale (r = 0.488), HOS Sports-Specific subscale (r = 0.500), modified Harris Hip Score (r = 0.465), 12-item International Hip Outcome Tool (r = 0.494), VAS pain score (r = −0.346), and VAS satisfaction score (r = 0.459). Conclusion: Patients undergoing hip arthroscopy for FAIS derived substantial benefit from each PT visit during their first 13 PT sessions and then a smaller, yet still meaningful benefit from sessions 13 through 27. After session 40, or approximately 4.5 to 5 months, patients no longer benefited from additional PT sessions. Based on PRO scores, patients discharged from PT between 3 and 6 months had the best 2-year outcomes. LEFS score had moderate correlation with orthopaedic PRO scores.

The impact of intestinal stoma formation on patient quality of life after emergency surgery-A systematic review.

Elective stoma formation has a negative effect on patient quality of life (QoL), with a potential detrimental impact on body image, confidence and social functioning being shown previously. However, the impact of emergency stoma formation on QoL has been explored less frequently. This systematic review aims to synthesize all available literature exploring QoL via patient-reported outcome measures. A search strategy was implemented on 24 November 2022 across Embase, MEDLINE, PsycInfo and the Cochrane Library database after registration on PROSPERO (CRD42022370606). Studies were included if they used a standardized patient-reported outcome measure, had more than five emergency stoma patients, age > 18 years and were fully published in English. Two of three independent researchers screened articles, extracted data and performed quality assessment using the Newcastle-Ottawa Scale and the Cochrane risk of bias tool. In all, 1775 articles were screened, with 16 included in the systematic review. This included 1868 emergency stoma patients (men:women 0.53; median age 64.6 years) followed up for a median of 12 months. Patients who had a Hartmann's procedure for perforated diverticulitis had poorer QoL than those who underwent primary anastomosis. There was a negligible difference in QoL between those who had a colonic stent for obstructing colorectal cancer compared with those who underwent emergency stoma formation. Female sex, end stoma formation and ileostomy formation were all identified as risk factors for poorer QoL. Patients undergoing emergency stoma surgery have marginally poorer QoL compared with those undergoing similar procedures without stoma formation. Further work is required to identify risk factors associated with this and also to compare QoL after stoma reversal.

Development of a Patient-Reported Outcome Measure to Assess Symptoms Associated with Cataract Surgery and Intraocular Lens Implants

To develop a standardized patient-reported outcome measure of visual perceptions and symptoms for implanted premium and monofocal intraocular lenses (IOLs). Observational study before and after IOL implants to assess the measure and symptom experience. Adults scheduled for binocular implantation of the same IOL type completed the survey at baseline prior to surgery (n = 716) and postoperatively (n = 554). Most respondents were female (64%), White (81%), 61 or older (89%), and had some college or more education (62%). Administration was by web survey with mail follow-up and phone reminders. Frequency, severity, and level of symptom bother in the last 7 days for 14 symptoms: (1) glare, (2) hazy vision, (3) blurry vision, (4) starbursts, (5) halos, (6) snowballs, (7) floaters, (8) double images, (9) rings and spider webs, (10) distortion, (11) light flashes with eyes closed, (12) light flashes with eyes open, (13) shimmering images, and (14) dark shadows. The median correlation among having 14 symptoms at baseline was only 0.19. Mean uncorrected binocular visual acuity improved from a preoperative value of 0.47 logarithm of the minimum angle of resolution (logMAR; Snellen 20/59) to a postoperative value of 0.12 (20/26) and best-corrected binocular visual acuity improved from 0.23 logMAR (20/34) preoperative to 0.05 logMAR (20/22) postoperative. The most bothersome symptoms were reduced after surgery: preoperative/postoperative glare (84%/36%), blurry vision (68%/22%), starbursts (66%/28%), hazy vision (63%/18%), snowballs (55%/17%), and halos (52%/22%). All symptoms decreased significantly (P < 0.0001) from before to after surgery except for dark crescent-shaped shadows (4%/4%). The percentage of symptoms rated as quite a bit or extremely bothersome declined from before to after surgery except for dark crescent-shaped shadows (29%/32%): blurry vision (54%/15%), snowballs (52%/14%), glare (49%/15%), and halos (46%/14%). Having monofocal IOL implants was associated with significantly more reduction in halos, starbursts, glare, and rings and spider webs, but less improvement in self-reported general vision. This study provides support for the 37-item Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) instrument for use to assess symptoms and general perceptions of vision in clinical studies and clinical care. Proprietary or commercial disclosure may be found after the references.