Patient-reported Symptom Severity Research Articles

Abstract 7448: Serum IL-10 is associated with neurologic symptoms and interference in primary brain tumor patients

Abstract Background: Primary brain tumors (PBT) are associated with neurocognitive symptoms as a direct result of the tumor or its treatment. IDH-mutant gliomas are associated with longer survival, but with higher incidence of seizures and neurocognitive symptoms.​ Correlations between cytokines and neuroinflammation have been reported in other structural brain lesions but have not been evaluated in PBT. Here, we investigate elevated peripheral blood levels of proteins (cytokine levels) in a cross-sectional cohort (n=47) of adult, IDH-mutant PBT patients enrolled in a natural history study (NCT02851706, PI: T. Armstrong) versus healthy subjects (n=32) and the correlations between cytokine levels and patient-reported outcomes (PROs). Methods: Patient-reported symptoms and activity-related interference were collected via the MD Anderson Symptom Inventory-Brain Tumor at study entry. Serum samples were stored at -80°C for batch processing and used for biomarker analysis. Ten cytokines (interleukin-1β [IL-1β], IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, interferon-γ [IFN-γ], and tumor necrosis factor-α [TNF-α]) were quantified in duplicate using an immunoassay (V-Plex/Proinflammatory, Meso Scale Discovery [MSD], Rockville, MD). Lab personnel were blinded to diagnosis and patient clinical status. Mean concentration (pg/mL) levels or ‘present or not detectable’ values were used. Descriptive statistics, Mann-Whitney tests, and Spearman correlations were conducted at p <0.05. Results: The patient sample was mostly male (62%), White (70%), employed (64%), had no prior recurrence (62%), high grade (3-4) tumors (70%), and an average age at diagnosis of 36 years (SD: 9; median: 34; range: 20-53). The healthy subject sample was mostly female (53%) and White (72%), with an average age of 46 years (SD: 19; median: 50; range: 19-78). Five cytokines (IFN-γ, IL-6, IL-8, IL-10, and TNF-α) were detectable in patients and healthy subjects with levels of IL-6, IL-10, and TNF-α higher in patients than healthy subjects. Serum levels of IL-10 (mean rank=50.7 vs 24.3, p<0.001) and TNF-α (mean rank=50.6 vs 24.2, p<0.001) were higher in PBT patients when compared to healthy subjects. Only IL-10, but not other cytokines, positively correlated with severity of patient-reported symptoms [pain (r=0.290, p=0.048), numbness/tingling (r=0.302, p=0.039)], and activity-related interference, including work (r=0.323, p=0.027), and walking (r=0.402, p=0.005). Conclusions: Higher IL-10 levels and detection differences in other cytokines, may indicate a reduction in immune-mediating processes and heightening inflammation in patients. Future analysis will include replication of this work in a larger cohort across PBT types to evaluate risk, explore mechanisms, and associations with treatment types. Citation Format: Kaitlynn A. Slattery, Michelle L. Wright, Dhaivat Raval, Emory Hsieh, McKenzie C. Kauss, Terri S. Armstrong, Tito R. Mendoza, Vivian A. Guedes. Serum IL-10 is associated with neurologic symptoms and interference in primary brain tumor patients [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 7448.

A comparison of the prevalence of dry mouth and other symptoms using two different versions of the Edmonton Symptom Assessment System on an inpatient palliative care unit

BackgroundSymptom assessment is key to effective symptom management and palliative care for patients with advanced cancer. Symptom prevalence and severity estimates vary widely, possibly dependent on the assessment tool used. Are symptoms specifically asked about or must the patients add them as additional symptoms? This study compared the prevalence and severity of patient-reported symptoms in two different versions of a multi-symptom assessment tool. In one version, three symptoms dry mouth, constipation, sleep problems were among those systematically assessed, while in the other, these symptoms had to be added as an “Other problem”.MethodsThis retrospective cross-sectional study included adult patients with advanced cancer at an inpatient palliative care unit. Data were collected from two versions of the Edmonton Symptom Assessment System (ESAS): modified (ESAS-m) listed 11 symptoms and revised (ESAS-r) listed 9 and allowed patients to add one “Other problem”. Seven similar symptoms were listed in both versions.ResultsIn 2013, 184 patients completed ESAS-m, and in 2017, 156 completed ESAS-r. Prevalence and severity of symptoms listed in both versions did not differ. In ESAS-m, 83% reported dry mouth, 73% constipation, and 71% sleep problems, but on ESAS-r, these symptoms were reported by only 3%, 15% and < 1%, respectively. Although ESAS-r severity scores for these three symptoms were higher than on ESAS-m, differences did not reach statistical significance.ConclusionWe identified significant differences in patient symptom reporting based on whether symptoms like dry mouth, obstipation and sleep problems were specifically assessed or had to be added by patients as an “Other problem”.

Talking in primary care (TIP): protocol for a cluster-randomised controlled trial in UK primary care to assess clinical and cost-effectiveness of communication skills e-learning for practitioners on patients’ musculoskeletal pain and enablement

IntroductionEffective communication can help optimise healthcare interactions and patient outcomes. However, few interventions have been tested clinically, subjected to cost-effectiveness analysis or are sufficiently brief and well-described for implementation in...

EXPLORING THE RELATIONSHIP BETWEEN PATIENT SYMPTOMS AND PROVIDER GOALS FOR MUCOSAL HEALING IN IBD: INSIGHTS FROM THE IBD QORUS SURVEY DATA

Abstract INTRODUCTION Patients with inflammatory bowel disease (IBD) often experience symptoms such as abdominal pain, diarrhea, and bloody bowel movements. While these symptoms traditionally guided treatment, their predictive value for disease progression is limited. The latest STRIDE-II guidelines recommend a comprehensive IBD management approach, with an emphasis on short-term symptom relief, intermediate-term biomarker normalization, and long-term achievement of endoscopic remission. This treat-to-target strategy necessitates collaboration between physicians and patients. Our study aims to investigate the relationship between patient-reported outcomes and physician efforts to achieve mucosal healing (MH) using IBD QORUS patient and provider survey data. METHODS This was a multi-center prospective study that used patient and provider matched survey data from the Crohn’s &amp; Colitis Foundation IBD QORUS program. Surveys completed between June 2021-October 2022 were analyzed. Univariate and multivariate analyses were performed to determine the relationship between severity of patient reported symptoms and frequency of MH assessment with modalities including endoscopy and fecal calprotectin, as well as to determine how symptoms and MH status influence treatment. RESULTS In total 5,460 paired patient and provider surveys (Crohn’s disease (CD), n=3,276; ulcerative colitis (UC), n=2,184) were included in the analysis. Demographic information including age, sex and steroid-free MH, as well as severity of patient-reported symptoms were similar between CD and UC patients (Table 1). Abdominal pain severity reported by both IBD populations significantly impacted plans for future endoscopy (CD, p=0.000019; UC, p=0.000055) but not for fecal calprotectin testing. Reported stool frequency in both IBD populations significantly impacted future endoscopy plans (CD, p=0.000001; UC, p=0.000001) and future fecal calprotectin testing (CD, p=0.000304; UC, p=0.000001). Reported blood in stool had no effect on MH assessment in CD patients whereas it significantly affected plans for endoscopy (p=0.000001) and fecal calprotectin testing (p=0.000001) in UC patients. Provider discussions regarding MH occurred with 82.4% of CD patients and 85.3% of UC patients, and treatment plans in those without steroid free MH were influenced by severity of symptoms (p=0.000001). DISCUSSION Patient reported symptoms influenced fecal calprotectin and endoscopy plans in both IBD groups. Similarly, severity of symptoms in those without steroid-free MH significantly affected treatment management. These findings suggest that target-based treatment for IBD is feasible in the clinical setting and holds the potential to enhance patient outcomes.

UTE T2* cartilage mapping in the hip: a pilot study assessing cartilage in patients with femoroacetabular impingement.

UTE T2* cartilage mapping use in patients undergoing femoroacetabular impingement (FAI) has been lacking but may allow the detection of early cartilage damage. To assess the reproducibility of UTE T2* cartilage mapping and determine the difference in UTE T2* values between FAI and asymptomatic patients and to evaluate the correlation between UTE T2* values and patient-reported symptoms. Prospective evaluation of both hips (7 FAI and 7 asymptomatic patients). Bilateral hip 3-T MRI scans with UTE T2* cartilage maps were acquired. A second MRI scan was acquired 1-9 months later. Cartilage was segmented into anterosuperior, superior, and posterosuperior regions. Assessment was made of UTE T2* reproducibility (ICC). Mean UTE T2* values in patients were compared (t-tests) and correlation was made with patient-reported outcomes (Spearman's). ICCs of mean UTE T2* were as follows: acetabular, 0.82 (95% CI=0.50-0.95); femoral, 0.76 (95% CI=0.35-0.92). Significant strong correlation was found between mean acetabular UTE T2* values and iHOT12 (ρ = -0.63) and moderate correlation with mHHS (ρ = -0.57). There was no difference in mean UTE T2* values between affected vs. non-affected FAI hips. FAI-affected hips had significantly higher values in acetabulum vs. asymptomatic patients (13.47 vs. 12.55 ms). There was no difference in mean femoral cartilage values between the FAI-affected hips vs. asymptomatic patients. The posterosuperior femoral region had a higher mean value in non-affected FAI hips vs. asymptomatic patients (12.60 vs. 11.53 ms). UTE T2* cartilage mapping had excellent reproducibility. Affected FAI hips had higher mean acetabular UTE T2* values than asymptomatic patients. Severity of patient-reported symptoms correlates with UTE T2* acetabular cartilage values.

Specialty Palliative Care and Symptom Severity and Control in Adolescents and Young Adults With Cancer

Adolescents and young adults (AYAs) with cancer experience substantial symptom burden. Specialty palliative care (SPC) is recommended but often not involved or involved late. To determine whether patient-reported symptom severity was associated with subsequent SPC involvement and whether SPC was associated with symptom improvement in AYAs with cancer. This cohort study comprised AYAs (aged 15-29 years) with primary cancer diagnosed between January 1, 2010, and June 30, 2018, in Ontario, Canada. Data, including self-reported Edmonton Symptom Assessment System (ESAS) scores, were obtained from health care databases. Specialty palliative care was identified through billing codes and validated algorithms. Final data analysis was performed on April 4, 2023. Associations of ESAS scores with subsequent SPC involvement were determined. A difference-in-differences approach was used for patients who died within 5 years of their cancer diagnosis. Case patients (SPC predeath, index date equals first SPC service) were matched 1:1 to control patients (no SPC at equivalent time before death). The study examined whether the difference between 90-day postindex and preindex mean ESAS scores was itself different between case and control patients. This study included 5435 AYAs with cancer, with a median follow-up of 5.1 (IQR, 2.5-7.9) years for analyses of general palliative care. Their median age at cancer diagnosis was 25 (IQR, 22-27) years, and more than half were male (2809 [51.7%]). For all symptoms, moderate and severe ESAS scores were associated with an increased likelihood of SPC involvement compared with mild scores. The greatest magnitude of association was seen for pain scores (hazard ratio for severe vs mild, 7.7 [95% CI, 5.8-10.2]; P < .001). A total of 721 AYAs (13.3%) died within 5 years of diagnosis, and 612 of these patients (84.9%) had received SPC before death. Among 202 case-control pairs, SPC involvement was associated with improved pain trajectories (mean scores improved from 3.41 to 3.07 in case patients and worsened from 1.86 to 2.16 in control patients; P = .003). Other symptom trajectories were not affected. In this cohort study of AYAs with cancer, those reporting moderate or severe symptoms through a screening program were more likely to subsequently receive SPC. These findings suggest that SPC was associated with a subsequent decrease in pain severity but did not affect other symptoms. New interventions targeting other symptoms during treatment and particularly at the end of life are needed.

Agreement between physician- and patient-reported Canadian cardiovascular society scores among patients undergoing elective coronary angiography-The CATS study.

The primary aim of revascularization in stable coronary artery disease (CAD) is symptom relief. The severity of symptoms is usually evaluated by the physician, not by the patient. We examined the agreement between physician- and patient-reported Canadian Cardiovascular Society (CCS) scores among patients scheduled for elective coronary angiography in a cross-sectional study. Patients (n = 650) and cardiologists evaluated the severity of angina symptoms by filling the CCS questionnaire before coronary angiography. Patients were divided into those without CAD (stenosis diameter <50%, n = 445) and those with CAD (stenosis diameter >50%, n = 205). CAD patients were further divided into three groups according to disease severity (single-, double- or triple-vessel disease). The mean age of the patients was 67.6 (9.9) years and 50.6% were women. In 51.8% (95% CI 44.5%-59.0%) of patients with CAD and 51.9% (95% CI 47.0%-56.8%) of those without, physician- and patient reported CCS scores agreed. The physician reported better CCS scores in 33.9% (95% CI 27.6%-40.7%) of patients with CAD and 36.2% (95% CI 31.8%-41.0%) of patients without CAD. The proportions of full or partial agreement between physician- and patient reported CCS scores were similar across the CAD severity groups. To summarize, we observed a significant discrepancy between the physician- and patient-reported symptom severity in patients with or without CAD scheduled for angiography. The physician underestimated the symptoms in third of the cases. Thus, patient-reported symptom severity, rather than physician's evaluation, should be the cornerstone of treatment decisions.

Baseline Patient-reported Symptoms Less Predictive Than MM-SES-CD for Endoscopic Remission in Crohn's Disease.

This analysis evaluates the association between baseline patient-reported symptom (PRS) severity in Crohn's disease (CD), including abdominal pain, stool frequency, general well-being, and achievement of clinical and endoscopic outcomes. We compared baseline PRS to baseline endoscopic scores for the prediction of endoscopic remission (ER). This post hoc analysis of 2 clinical trials of infliximab in CD included 601 patients and evaluated baseline PRS variables (abdominal pain, stool frequency, and general well-being) as measured by the Crohn's disease activity index and their association with 6-month clinical remission (CR) (Crohn's Disease Activity Index<150), corticosteroid-free CR, and week 26/54 ER (absence of mucosal ulceration). Logistic regression models assessed the relationships between PRS and outcomes of interest. Receiver operating characteristic curve analyses compared the sensitivity and specificity of the different baseline PRS compared with baseline endoscopic scores for achievement of ER at weeks 26 and 54. No difference was found comparing patients with higher baseline PRS to those with lower PRS in achieving 6-month CR, 6-month corticosteroid-free CR, or week 26/54 ER. Modified multiplier of the SES-CD (MM-SES-CD) at baseline demonstrated a significant ability to predict week 54 ER (area under the curve, 0.71; 95% CI 0.65-0.78; P =0.017). Baseline PRS in CD is not prognostic of clinical or endoscopic response. In contrast, active endoscopic disease as measured by the MM-SES-CD, more accurately predicts endoscopic outcomes. Endoscopic scores such as the MM-SES-CD may be considered for selection criteria and as a primary outcome of interest in CD trials, with PRS as a co-primary or secondary endpoint.

Irritable Bowel Syndrome Patient Experience: A Survey of Patient-Reported Symptoms by Irritable Bowel Syndrome Subtype and Impact on Quality of Life.

Irritable bowel syndrome (IBS) is a chronic, debilitating, functional gastrointestinal disorder with symptoms of abdominal pain, bloating, and altered bowel behaviours of constipation (IBS-C), diarrhea (IBS-D), or a mixture of both (IBS-M). There is limited information published on the impact of symptoms on everyday life in the Canadian population. An online survey was conducted with individuals diagnosed with IBS to capture the severity and frequency of patient-reported symptoms, including impact on productivity, quality of life, healthcare utilization, treatment access, and corresponding symptom relief. Responses from the three subtypes of IBS were categorized to illustrate differences among these. There were 2,470 qualified respondents (filtered from 2,981, which included nonspecific IBS). IBS-M was the most common subtype, at 44 percent. Most individuals from all three IBS subtypes reported experiencing moderate to severe abdominal pain (63-70 percent) and bloating (59-75 percent) over the previous 3 months. Persons living with IBS-C reported severe bloating (32 percent), straining (72 percent), and tenesmus (78 percent) whereas those with IBS-D experienced severe urgency (63 percent) and incontinence (29 percent). Symptoms interfered in daily life, sometimes in 46 percent and often in 23 percent of respondents. Patients reported mood and anxiety disorders as common comorbidities with IBS (mood disorders: 30-34 percent; anxiety disorders: 25-30 percent). This study focuses on the differences among the IBS subtypes. IBS impacts productivity and healthcare utilization, which requires further investigation on approaches to improve treatment. The frequency and severity of symptoms in IBS are high and only a few respondents reported that their symptoms are under control.

Psoriatic Arthritis And Covid-19 - Patient Perspectives In A Large Psoriatic Arthritis Cohort.

To estimate the prevalence of COVID-19 infection among patients with psoriatic arthritis (PsA), understand patients' perspectives regarding their risk of COVID-19 infection, and evaluate the standard of virtual care offered during the early phases of the pandemic. An online survey was conducted between June and September 2021 in PsA patients who had consented to email contact. The survey was completed by 152/193 (79%) patients who had consented to the study. There were 86 (57%) men and 66 women, mean age 58 years, mean disease duration 19 years. During the pandemic, the mean patient-reported symptom severity was 4.1, 3.2, and 3.7 for joint, skin, and overall symptom severity, respectively. 74% of respondents would accept the impact of their PsA over the past month for the next few months. Of 79 patients who were tested for SARS-COV-2, 4 tested positive. All 4 were admitted to hospital, 2 required oxygen. 151 patients (99%) had received at least one vaccine dose. 59 (39%) participants believed their PsA medications increased their COVID-19 infection risk. Of the 130 patients who had a telemedicine assessment, 83% were happy with their virtual consultations. Most were happy to continue with virtual consultations until the pandemic resolved. The average satisfaction level regarding pandemic care was 7.9 on a sliding 10-point scale. COVID-19 prevalence was low among our patients. Patients were satisfied with their care during the pandemic. Most patients would happily continue with virtual care for the duration of the pandemic.

An Unsupervised Machine Learning Approach to Evaluating the Association of Symptom Clusters With Adverse Outcomes Among Older Adults With Advanced Cancer

Older adults with advanced cancer who have high pretreatment symptom severity often experience adverse events during cancer treatments. Unsupervised machine learning may help stratify patients into different risk groups. To evaluate whether clusters identified from baseline patient-reported symptom severity were associated with adverse outcomes. This secondary analysis of the Geriatric Assessment Intervention for Reducing Toxicity in Older Patients With Advanced Cancer (GAP70+) Trial (2014-2019) included patients who completed the National Cancer Institute Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) before starting a new cancer treatment regimen and received care at community oncology sites across the United States. An unsupervised machine learning algorithm (k-means with Euclidean distance) clustered patients based on similarities of baseline symptom severities. Clustering variables included severity items of 24 PRO-CTCAE symptoms (range, 0-4; corresponding to none, mild, moderate, severe, and very severe). Total severity score was calculated as the sum of 24 items (range, 0-96). Whether the clusters were associated with unplanned hospitalization, death, and toxic effects was then examined. Analyses were conducted in January and February 2022. Symptom severity. Unplanned hospitalization over 3 months (primary), all-cause mortality over 1 year, and any clinician-rated grade 3 to 5 toxic effect over 3 months. Of 718 enrolled patients, 706 completed baseline PRO-CTCAE and were included (mean [SD] age, 77.2 [5.5] years, 401 [56.8%] male patients; 51 [7.2%] Black and 619 [87.8%] non-Hispanic White patients; 245 [34.7%] with gastrointestinal cancer; 175 [24.8%] with lung cancer; mean [SD] impaired Geriatric Assessment domains, 4.5 [1.6]). The algorithm classified 310 (43.9%), 295 (41.8%), and 101 (14.3%) into low-, medium-, and high-severity clusters (within-cluster mean [SD] severity scores: low, 6.3 [3.4]; moderate, 16.6 [4.3]; high, 29.8 [7.8]; P < .001). Controlling for sociodemographic variables, clinical factors, study group, and practice site, compared with patients in the low-severity cluster, those in the moderate-severity cluster were more likely to experience hospitalization (risk ratio, 1.36; 95% CI, 1.01-1.84; P = .046). Moderate- and high-severity clusters were associated with a higher risk of death (moderate: hazard ratio, 1.31; 95% CI, 1.01-1.69; P = .04; high: hazard ratio, 2.00; 95% CI, 1.43-2.78; P < .001), but not toxic effects. In this study, unsupervised machine learning partitioned patients into distinct symptom severity clusters; patients with higher pretreatment severity were more likely to experience hospitalization and death. ClinicalTrials.gov Identifier: NCT02054741.

Parsley Health: Feasibility and acceptability of a large-scale holistic telehealth program for chronic disease care.

A holistic, personalized approach to medicine can be used to prevent and manage a variety of chronic diseases. However, effectively managing chronic diseases can be difficult due to barriers related to insufficient provider time, staffing, and lack of patient engagement. To address these challenges telehealth strategies are being increasingly adopted, yet few studies have explored how to evaluate the feasibility and implementation success of large-scale holistic telehealth models for chronic disease care. The aim of this study is to assess the feasibility and acceptability of a large-scale holistic telehealth program for the management of chronic diseases. Our study findings can inform the future development and assessment of chronic disease programs delivered through telehealth strategies. Data was collected from participants enrolled in a Parsley Health membership from June 1, 2021 to June 1, 2022, a subscription-based holistic medicine practice designed to help people prevent or manage chronic diseases. Implementation outcome frameworks were used to understand engagement with services, participant satisfaction, and preliminary effectiveness of the program via a patient-reported symptom severity tool. Data from 10,205 participants with a range of chronic diseases were included in our analysis. Participants averaged 4.8 visits with their clinical team and reported high levels of satisfaction with their care (average NPS score of 81.35%). Preliminary evidence also showed substantial reduction in patient reported symptom severity. Our findings suggest the Parsley Health program is a feasible and acceptable large-scale holistic telehealth program for chronic disease care. Successful implementation was due, in part, to services that promoted participant engagement along with tools and interfaces that were helpful and easy to use. These findings can be used to develop future holistic-focused telehealth programs for the management and prevention of chronic diseases.

Patient-Reported Symptom Severity, Health-Related Quality of Life, and Emotional Distress Trajectories During and After Radiation Therapy for Human Papillomavirus–Associated Oropharyngeal Cancer: A TROG 12.01 Secondary Analysis

This secondary analysis of clinical trial TROG 12.01, involving patients with human papillomavirus-associated oropharyngeal squamous cell carcinoma, aimed to identify patient-reported outcome (PRO) trajectories before, during, and after chemoradiotherapy. Head and neck cancer symptom severity (HNSS) and interference (HNSI), generic health-related quality of life (HRQL), and emotional distress were assessed with the MD Anderson Symptom Inventory-Head and Neck, Functional Assessment of Cancer Therapy-General, and Hospital Anxiety and Depression Scale questionnaires, respectively. Latent class growth mixture modeling (LCGMM) was used to identify distinct underlying trajectories. Baseline and treatment variables were compared between trajectory groups. The LCGMM identified latent trajectories for all PROs: HNSS, HNSI, HRQL, anxiety, and depression. Four HNSS trajectories (HNSS1-4) were identified, distinguished by differences in HNSS at baseline, during the peak of treatment symptoms, and during early and intermediate recovery. All trajectories were stable beyond 12 months. The reference trajectory (HNSS4, n=74) score was 0.1 (95% confidence interval [CI], 0.1-0.2) at baseline, peaking at 4.6 (95% CI, 4.2-5.0), with rapid early recovery (1.1; 95% CI, 0.8-2.2) and gradual improvement to 12 months (0.6; 95% CI, 0.5-0.8). Patients in HNSS2 (high baseline, n=30) reported higher baseline scores (1.4; 95% CI, 0.8-2.0) but were otherwise similar to HNSS4. Patients in HNSS3 (low acute, n=53) reported reduced acute symptoms (2.5; 95% CI, 2.2-2.9) with stable scores beyond 9 weeks after chemoradiotherapy (1.1; 95% CI, 0.9-1.4). Patients in HNSS1 (slow recovery, n=25) had slower recovery from an acute peak of 4.9 (95% CI, 4.3-5.6) to 0.9 (95% CI, 0.6-1.3) at 12 months. Age, performance status, education, receipt of cetuximab, and baseline anxiety varied between trajectories. The other PRO models demonstrated clinically relevant trajectories, with distinct associations with baseline factors. LCGMM identified distinct PRO trajectories during and after chemoradiotherapy. These and their associations with variations in the characteristics and treatment factors of patients with human papillomavirus-associated oropharyngeal squamous cell carcinoma provide clinically relevant insights into identifying patients who may require increased support before, during, or after chemoradiotherapy.

Body mass index and patient-reported function, quality of life and treatment toxicity in women receiving adjuvant chemotherapy for breast cancer.

This study investigates whether high body mass index (BMI) in women diagnosed with early breast cancer (BC) is associated with patient-reported symptom severity during chemotherapy. Women with Stage I-III BC completed toxicity reports for 17 side effects throughout regularly scheduled chemotherapy infusions. Toxicity reports were compared in women with obesity (BMI > = 30) versus no obesity (BMI < 30). Fisher's exact tests and 2-sample t-tests compared baseline patient characteristics. Risk ratios (RR) for women with obesity as compared to no obesity were estimated for individual symptoms that were patient-rated as moderate, severe or very severe (MSVS) severity, adjusting for marital status and race. In a sample of 286 patients, Black women comprised 23% of the sample. The obesity rate was 76% among Black patients and 31% among White patients (p < .0001). Women with obesity rated an average of 6.9 side effects (standard deviation, SD 4.2) as MSVS vs 5.5 side effects (SD 3.7) among women with no obesity (p = .003). In adjusted analysis, women with obesity had significantly greater risk for MSVS fatigue (RR 1.18, 95% CI 1.01-1.36), dyspnea (RR 1.71, 95% CI 1.09-2.69), arthralgia (RR 1.47, 95% CI 1.10-1.97), peripheral neuropathy (RR 1.45, 95% CI 1.01-2.08), edema of limbs (RR 1.84, 95% CI 1.18-2.88), and abdominal pain (RR 1.75, 95% CI 1.07-2.87). There were no inter-group differences in BC stage or phenotype, chemotherapy treatment modifications, or hospitalizations. Among women with early BC, patients with obesity reported higher chemotherapy toxicity as compared to patients without obesity; however, this did not result in differences in treatment completion.

Ulcerative Colitis-Symptom Questionnaire: Valid for Use in Adults with Moderately to Severely Active Ulcerative Colitis

BackgroundDue to wide-ranging impacts of Ulcerative Colitis (UC), regulatory authorities emphasize the importance of including validated patient-reported symptom severity measures in clinical trials.AimTo describe the development and validation of the Ulcerative Colitis-Symptom Questionnaire (UC-SQ).MethodsThe UC-SQ was developed in a qualitative study involving a targeted literature review, semi-structured concept elicitation interviews, and combined concept elicitation/cognitive interviews. Measurement properties, including item-level analyses, factor structure, reliability, validity, responsiveness, and clinically meaningful change were evaluated using data from a phase 2b, randomized trial in adults with UC (N = 113).ResultsFourteen symptom concepts were elicited across 22 interviews, with saturation at the fifth interview. Twenty-two items were unmodified as cognitive interview participants interpreted underlying concepts correctly. Instructions were clear and items were relevant, with appropriate response options and recall periods. Reduction to 17 items was completed prior to psychometric testing. Two items (joint pain/constipation) did not contribute to reliability in initial testing and were included as non-scored items. The 15-item UC-SQ showed evidence of internal consistency (α = 0.86) and test–retest reliability (intraclass correlation coefficient = 0.88). The UC-SQ discriminated by disease severity as defined by Mayo and Inflammatory Bowel Disease Questionnaire scores (p < 0.0001). Convergent validity was supported by strong correlations with criterion measures. The UC-SQ was responsive in patients indicating change in other measures. A 10-point decrease from baseline indicated within-patient meaningful improvement.ConclusionsThe UC-SQ is reliable, valid and responsive, with a 10-point improvement estimating within-patient clinically meaningful improvement. The tool is fit-for-purpose as a key endpoint in pivotal UC trials.

Gastrointestinal-Specific symptom anxiety in patients with gastroparesis: Relationships to symptom severity and quality of life.

Gastrointestinal (GI)-specific anxiety has been identified as a treatment target in irritable bowel syndrome. However, GI-specific anxiety has been understudied in other GI functional/motility disorders. Among adults with gastroparesis, we aimed to: (1) initially validate a measure of GI-specific anxiety, the Visceral Sensitivity Index (VSI); and (2) evaluate the relationship between GI-specific anxiety and gastroparesis symptom severity and quality of life, compared to measures of anxiety, depression, and somatization. Consecutive adult patients (N=100) with gastroparesis presenting for initial consultation completed a series of self-report measures including the VSI. We conducted a confirmatory factor analysis of the VSI one-factor structure and tested internal consistency and convergent validity. We then performed hierarchical linear regression analyses to explore associations between VSI and gastroparesis symptom severity and overall quality of life. Confirmatory factor analysis revealed that the original VSI one-factor structure overall fit well [χ2 (90)=220.1, p < 0.0001; SRMR=0.08; RMSEA=0.12; CFI=0.96]. The VSI also had excellent internal consistency (α=0.99) and convergent validity (r=0.29-0.56; all p < 0.01). Higher GI-specific anxiety was significantly associated with greater gastroparesis symptom severity, including nausea/vomiting, fullness/satiety, and upper abdominal pain scores beyond depression, anxiety, or somatization (all p=<0.01-0.01). Additionally, higher GI-specific anxiety was significantly associated with lower mental health-related quality of life, beyond gastroparesis symptom severity, depression, anxiety, or somatization (p=0.01). The VSI is an adequate measure of GI-specific anxiety in patients with gastroparesis. Higher GI-specific anxiety was associated with increased patient-reported gastroparesis symptom severity and decreased quality of life, beyond depression/anxiety.

Predictors of patient-reported fatigue symptom severity in a nationwide multiple sclerosis cohort.

Fatigue is a debilitating symptom of multiple sclerosis (MS), but its relation to sociodemographic and disease-related characteristics has not been investigated in larger studies. The objectives of this study were to evaluate predictors of self-reported fatigue in a Swedish nationwide register-based MS cohort. Using a repeated cross-sectional design, we included 2,165 persons with relapsing- remitting and secondary progressive MS with one or multiple Fatigue Scale for Motor and Cognitive Functions (FSMC) scores, which was modelled using multivariable linear regressions for multiple predictors. Only associations to expanded disability status scale (EDSS) and Symbol Digit Modalities Test (SDMT) were considered clinically meaningful among MS-associated characteristics in our main model; compared to mild disability (EDSS 0-2.5), those with severe disability (EDSS ≥6) scored 17.6 (95% CI 13.1-22.2) FSMC points higher, while the difference was 10.7 (95% CI 8.0-13.4) points for the highest and lowest quartiles of SDMT. Differences between highest and lowest quartiles of health-related quality of life (HRQoL) instruments were even greater and considered clinically meaningful; EuroQoL Visual Analogue Scale (EQ-VAS) 31.9 (95% CI 29.9-33.8), Multiple Sclerosis Impact Scale (MSIS-29) psychological component 35.6 (95% CI 33.8-37.4) and MSIS-29 physical component 45.5 (95% CI 43.7-47.4). Higher self-reported fatigue is associated with higher disability level and worse cognitive processing speed, while associations to other MS-associated characteristics including MS type, line of disease modifying therapy (DMT), MS duration, relapse and new cerebral lesions are weak. Furthermore, we found a strong correlation between high fatigue rating and lower ratings on health-related quality of life instruments.

Insomnia in Patients Undergoing Hypoglossal Nerve Stimulation Therapy for Obstructive Sleep Apnea.

Hypoglossal nerve stimulation (HGNS) is a treatment for obstructive sleep apnea (OSA) patients with intolerance of positive airway pressure therapy. Comorbid insomnia is quite prevalent in OSA patients. We investigated the impact of insomnia and excessive daytime sleepiness (EDS) on polysomnography metrics after HGNS treatment. Data of 27 consecutive patients (9 female; mean age 55.52 ± 8.6 years) were retrospectively evaluated. Insomnia was assessed using the ISI (insomnia severity index) and EDS using the Epworth sleepiness scale (ESS). The median ISI was reduced significantly 3 months after HGNS activation (preoperative: 19; postoperative: 14; p &lt; 0.01). Significant correlations emerged between preoperative ISI and postoperative AHI (apnea/hypopnea index; Spearman's rho = 0.4, p &lt; 0.05), ∆ AHI (r = -0.51, p &lt; 0.01) and ∆ ODI (oxygen desaturation index; r = -0.48, p &lt; 0.05). ISI correlated strongly with EES both preoperatively (r = 0.46; p &lt; 0.02) and postoperatively (r = 0.79; p &lt; 0.001). Therefore, HGNS therapy is associated with a significant reduction of insomnia-related symptoms, in addition to the improvement in respiratory metrics in OSA. Nonetheless, the preoperative severity of patient-reported insomnia symptoms was inversely correlated with the respiratory PSG-outcomes after HGNS. Insomnia should be considered in studies of EDS in OSA patients, especially those treated with HGNS.

Mobile Postoperative Symptom Intervention Tool and Biometric Monitoring After Radical Cystectomy: Pilot Study Evaluating Feasibility, Usability, and Potential Utility.

Mobile health technology and integration of patient-reported outcome measures into clinical interventions have the potential to transform patient care. Though patient-reported outcome measure management has been shown to improve outcomes in ambulatory care settings, few studies have examined remote patient-reported outcome measure assessment after major cancer surgery. A multiphased feasibility and usability study was designed. A mobile app-based postoperative symptom intervention tool was developed and evaluated by a focus group of bladder cancer patients and caregivers. Patients were prospectively accrued prior to cystectomy and asked to complete the daily mobile postoperative symptom intervention tool and wear biometric monitoring devices for 30 days post discharge. Retention, postoperative symptom intervention tool completion, and usability were assessed. Exploratory analysis of daily symptoms and patient-generated health information correlated signals with postsurgical complications and hospital readmission. Fifteen patients with a median age of 72 years completed 78% of daily surveys over the 30-day recovery period. Average time to complete the postoperative symptom intervention tool was 152 seconds. All patients agreed that the daily survey was easy to use, and most reported it would be a better way to communicate with the care team about symptoms than calling the clinic. Frequency and severity of patient-reported symptoms appeared to cluster prior to or at the time of complication or unplanned health care encounters on visual-analogue mapping. Using smartphone and wearable technology to capture patient-reported symptoms and biometric data is feasible and rated as highly usable by bladder cancer patients after cystectomy. Symptom scores may signal developing complications and help clinicians identify postsurgical patients who may benefit from intervention.

Machine learning models for 180-day mortality prediction of patients with advanced cancer using patient-reported symptom data

PurposeThe objective of the current study was to develop and test the performances of different ML algorithms which were trained using patient-reported symptom severity data to predict mortality within 180 days for patients with advanced cancer.MethodsWe randomly selected 630 of 689 patients with advanced cancer at our institution who completed symptom PRO measures as part of routine care between 2009 and 2020. Using clinical, demographic, and PRO data, we trained and tested four ML algorithms: generalized regression with elastic net regularization (GLM), extreme gradient boosting (XGBoost) trees, support vector machines (SVM), and a single hidden layer neural network (NNET). We assessed the performance of algorithms individually as well as part of an unweighted voting ensemble on the hold-out testing sample. Performance was assessed using area under the receiver-operating characteristic curve (AUROC), sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).ResultsThe starting cohort of 630 patients was randomly partitioned into training (n = 504) and testing (n = 126) samples. Of the four ML models, the XGBoost algorithm demonstrated the best performance for 180-day mortality prediction in testing data (AUROC = 0.69, sensitivity = 0.68, specificity = 0.62, PPV = 0.66, NPV = 0.64). Ensemble of all algorithms performed worst (AUROC = 0.65, sensitivity = 0.65, specificity = 0.62, PPV = 0.65, NPV = 0.62). Of individual PRO symptoms, shortness of breath emerged as the variable of highest impact on the XGBoost 180-mortality prediction (1-AUROC = 0.30).ConclusionOur findings support ML models driven by patient-reported symptom severity as accurate predictors of short-term mortality in patients with advanced cancer, highlighting the opportunity to integrate these models prospectively into future studies of goal-concordant care.