Changes In Symptom Burden Research Articles

Race differences in patient-reported symptoms and adherence to adjuvant endocrine therapy among women with early-stage, hormone receptor-positive breast cancer.

12102 Background: Low rates of adherence to adjuvant endocrine therapy (AET) is a significant clinical problem. Symptom burden is a key barrier to adherence, but less is known about how changes in symptom burden affects adherence. Moreover, whether higher symptom burden in racial minorities explains their lower rates of adherence, has been relatively unexamined. We used longitudinal data to address these gaps in knowledge. Methods: Using electronic medical records linked with patient-reported data, Medicare and Medicaid claims, we identified women with early-stage, hormone receptor-positive breast cancer who initiated AET from a large cancer center in 08/2007-12/2015, had continuous insurance coverage and ≥1 symptom report before and during AET. Patient-reported symptoms were collected using a tablet-based platform [ConcertAI]. A total of 49 physical symptoms and 11 mental health symptoms were evaluated and classified into 7 physical and 2 mental clusters based on previous literature and clinical expertise. For each cluster, we counted the number of symptoms with moderate severity (≥3 points) at baseline, and with ≥3-point increase during 1-year follow-up. Adherence was defined as the percent of days covered by AET during the 1-year follow-up. We compared Black and White patients’ symptoms at baseline and changes during the therapy, and conducted multivariable regression for patients’ adherence adjusting for race, symptom measures, sociodemographic and clinical characteristics. Results: Black women (n = 168) were diagnosed at a younger age, with more advanced stage, and lived in areas with lower socioeconomic status than White women (n = 391, p<.05). Adherence to AET in the first year was 78.8% for Black and 82.3% for White women ( p=.16). Black women experienced higher severity in most symptom clusters at baseline and during the follow-up than White women ( p<.05). Neuropsychologic, Vasomotor, Musculoskeletal, Cardiorespiratory, Distress and Despair symptom clusters both at baseline and their increases during the follow-up were associated with 1.2 to 2.6 percentage points (ppt, p<.05) decreases in adherence. This means, each additional count of moderate severity symptoms in these clusters would decrease 4 to 9 days on AET. After adjusting for distress and despair symptoms, Black women had a 6.5 ppt higher adherence rate than White ( p<.05). Conclusions: Black women had higher symptom burden at baseline and during the first year of AET. Both physical and mental health symptoms at baseline and the changes during therapy were associated with lower adherence. However, Black women had non-significantly lower rates of adherence despite the higher symptom burden due to unmeasured factors that offset the impact of symptom severity. Better symptom management could improve AET adherence and potentially reduce racial disparities in cancer outcomes.

Persistence of headache and its relation to other major sequelae following traumatic brain injury at 2-8years after deployment-related traumatic brain injury in veterans of Afghanistan and Iraq wars.

This study deals with headache in relation to other major sequelae of traumatic brain injury (TBI) in veterans of Iraq and Afghanistan wars over 8years after experiencing a deployment-related TBI (DTBI). TBI occurred in 14%-23% of veterans deployed to the Iraq or Afghanistan campaigns. This study evaluates sequelae of TBI (STBI) over 1-8years after a DTBI. This is a secondary, cross-sectional analysis of previously collected data, which was taken from review of medical records of the first 500 veterans with a DTBI seen in the TBI clinic of the Oklahoma City Veterans Health Center. This report deals with five of the most common STBIs and represents the presence and severity of, or absence of, the particular symptom at the time of a patient's initial visit to the clinic. All subjects were evaluated between June 1, 2008, and April 30, 2011. The STBI used here include: headache, dizziness, balance, coordination difficulties, and difficulty with decisions. In the TBI clinic, the burden of these symptoms was evaluated with a Likert Scale of none, mild, moderate, severe, or very severe. For this report, the scale was compressed into three categories: none, mild/moderate, and severe/very severe. Data were complete for age at TBI and mechanism of TBI in 500 subjects, for symptom severity in 497 subjects, for TBI severity in 491 subjects, and for presence of prior TBI in 496 subjects. For the 497 subjects with complete symptom severity data, headache was seen in 476 (95.8%) and absent in 21 (4.2%). Regarding headache severity, 236 (47.5%) reported mild/moderate and 240 (48.3%) reported severe/very severe headache burden. For other sequelae, including severity of dizziness, balance, and coordination problems, these symptoms were absent in 85 (17.1%), 85 (17.1%), and 106 (21.3%) patients, respectively; of mild/moderate severity in 356 (71.6%), 355 (71.4%), and 321 (64.6%) patients; and of severe/very severe intensity in 56 (11.3%), 57 (11.5%), and 70 (14.1%) patients. Difficulty with decisions, which was used as an indication of cognitive difficulty, was noted in 429 (86.3%) of the subjects, of which 252 (50.7%) noted mild/moderate and 177 (35.6%) severe/very severe intensity. To evaluate changes over time, the subjects were divided into 2-year cohorts of 1-2, 3-4, 5-6, and 7-8years since DTBI. Comparing symptom burden within these four 2-year cohorts, there was no statistically significant change in symptom burden analyzing by time interval from DTBI to TBI clinic evaluation. For analysis by severity of the DTBI in 491 subjects with complete data, categories were constructed based on alteration of consciousness (AOC) or duration of loss of consciousness (LOC) as follows: AOC (264/491 [53.8%]); LOC <1min (95/491 [19.4%]); LOC, 1-30min (115/491 [23.4%]); and LOC >30min (17/491 [3.5%]). The proportion of subjects with severe/very severe symptom intensity increased as the severity of the DTBI increased (from p=0.043 to p=0.001). Additional evaluations included groupings by age at DTBI (20-29, 30-39, and ≥40years), by presence or absence of a TBI prior to the DTBI, and by causation of the DTBI (blast or direct head trauma). No significant differences were observed with any of these comparisons. For veterans experiencing a DTBI, these TBI-related sequelae persist with little improvement over time up to 8years. A trend toward symptoms becoming worse as DTBI severity increased was observed. Headache was the most frequent sequela of TBI, occurring in 96% of the patients with almost half of these reporting severe/very severe intensity of headache burden. The basis for the prolonged persistence of these STBI is not known.

MO861: Symptom Improvement With Standard Care in People Receiving Haemodialysis Across a Range of Symptoms in the POS-S Renal: Consideration for Clinical Practice and Trial Design

Abstract BACKGROUND AND AIMS Although the high prevalence of symptoms experienced by haemodialysis patients is recognized, how these symptoms change over time is poorly understood, and could have implications for clinical practice and research. This study investigates the change in symptom burden over time with standard care using the POS-S renal questionnaire. METHOD Three times a week haemodialysis patients participating in a stepped wedge cluster randomized trial (SHAREHD) reported the severity of the 17 POS-S Renal symptoms (none, mild, moderate, severe and overwhelming) at baseline, 6, 12 and 18 months. Patients reporting moderate or worse for each of these symptoms at baseline were identified. Symptoms were categorized by the absolute change in population prevalence of individuals in the ‘severe’ group, estimated using multi-level mixed effects ordered probit regression adjusting for age, sex, time on HD and Charlson Comorbidity Score. To assess change within individuals, the proportion of patients changing their symptom score every 6 months was estimated, with &amp;gt;35% of patients remaining in the ‘severe’ category used to class a symptom as more stable. RESULTS 552 patients completed 1724 questionnaires across the four timepoints. Across all 17 symptoms with moderate or worse symptom severity at baseline, the majority of the change in population symptom prevalence occurred in the ‘severe’ category with moderate category remaining stable and mild/none prevalence increasing. The change in prevalence of the ‘severe’ category was 10%–20% &amp;gt;18 months in difficult sleeping, weakness, anxious, depression, shortness of breath, poor mobility, skin changes, drowsiness, pain, poor appetite, restless leg experienced an absolute improvement. Meanwhile greater absolute improvements in prevalence of 21–40% were observed in constipation, diarrhoea, sore mouth, pruritus, vomiting and nausea. Most of the symptoms with larger changes in population prevalence of the ‘severe’ category were associated with only 22–28% of patients remaining in the severe category at any one time. But larger prevalence change was driven by 9–18% difference between the proportion of patients moving out of severe compared with those moving into this category. Despite less change (10%–20%) in population prevalence of the ‘severe’ category in other symptoms, there was still a large degree of within patient movement that was relatively balanced in and out of the severe category. Examples include depression, skin changes and drowsiness, which had 75–80% movement both in and out of severe category each 6 months period, but maintained relatively static prevalence over time. All symptoms had &amp;gt;50% of patients in the severe group change their severity &amp;gt;6 months. CONCLUSION In response to standard care, the prevalence and movement in and out of the severe category can help characterize the longitudinal behavior of symptoms. More dramatic changes at the population and patient level in some symptoms could have a significant impact for clinical trial design as improvements are observed with standard care, which could be interpreted as a placebo effect. Symptom severity changes in more than 50% of patients within 6 months, arguing for routine measurement of symptom-based PROMS in haemodialysis population to identify individuals requiring intervention. Funded by VIFOR Pharma.

Effect of a Symptom Monitoring Intervention for Patients Hospitalized With Advanced Cancer

Symptom monitoring interventions are increasingly becoming the standard of care in oncology, but studies assessing these interventions in the hospital setting are lacking. To evaluate the effect of a symptom monitoring intervention on symptom burden and health care use among hospitalized patients with advanced cancer. This nonblinded randomized clinical trial conducted from February 12, 2018, to October 30, 2019, assessed 321 hospitalized adult patients with advanced cancer and admitted to the inpatient oncology services of an academic hospital. Data obtained through November 13, 2020, were included in analyses, and all analyses assessed the intent-to-treat population. Patients in both the intervention and usual care groups reported their symptoms using the Edmonton Symptom Assessment System (ESAS) and the 4-item Patient Health Questionnaire-4 (PHQ-4) daily via tablet computers. Patients assigned to the intervention had their symptom reports displayed during daily oncology rounds, with alerts for moderate, severe, or worsening symptoms. Patients assigned to usual care did not have their symptom reports displayed to their clinical teams. The primary outcome was the proportion of days with improved symptoms, and the secondary outcomes were hospital length of stay and readmission rates. Linear regression was used to evaluate differences in hospital length of stay. Competing-risk regression (with death treated as a competing event) was used to compare differences in time to first unplanned readmission within 30 days. From February 12, 2018, to October 30, 2019, 390 patients (76.2% enrollment rate) were randomized. Study analyses to assess change in symptom burden included 321 of 390 patients (82.3%) who had 2 or more days of symptom reports completed (usual care, 161 of 193; intervention, 160 of 197). Participants had a mean (SD) age of 63.6 (12.8) years and were mostly male (180; 56.1%), self-reported as White (291; 90.7%), and married (230; 71.7%). The most common cancer type was gastrointestinal (118 patients; 36.8%), followed by lung (60 patients; 18.7%), genitourinary (39 patients; 12.1%), and breast (29 patients; 9.0%). No significant differences were detected between the intervention and usual care for the proportion of days with improved ESAS-physical (unstandardized coefficient [B] = -0.02; 95% CI, -0.10 to 0.05; P = .56), ESAS-total (B = -0.05; 95% CI, -0.12 to 0.02; P = .17), PHQ-4-depression (B = -0.02; 95% CI, -0.08 to 0.04; P = .55), and PHQ-4-anxiety (B = -0.04; 95% CI, -0.10 to 0.03; P = .29) symptoms. Intervention patients also did not differ significantly from patients receiving usual care for the secondary end points of hospital length of stay (7.59 vs 7.47 days; B = 0.13; 95% CI, -1.04 to 1.29; P = .83) and 30-day readmission rates (26.5% vs 33.8%; hazard ratio, 0.73; 95% CI, 0.48-1.09; P = .12). This randomized clinical trial found that for hospitalized patients with advanced cancer, the assessed symptom monitoring intervention did not have a significant effect on patients' symptom burden or health care use. These findings do not support the routine integration of this type of symptom monitoring intervention for hospitalized patients with advanced cancer. ClinicalTrials.gov Identifier: NCT03396510.

The clinical value of psycho-gastroenterological interventions for functional esophageal symptoms.

Disorders of gut-brain interaction (DGBI) are associated with high symptom burden and poor quality of life. We evaluated the clinical value of multimodal therapy with psycho-gastroenterological interventions in patients with refractory functional symptoms. Of 80 DGBI patients managed over a 12-month period, 26 patients undergoing multimodal therapy (median age 60.0years, 73.1%F) were compared to 54 patients (median age 56.0years, 68.5%F) managed using conventional approaches. Psycho-gastroenterological multimodal therapy was individualized and included relaxation training (diaphragmatic breathing, passive muscle relaxation) and gut-direct hypnotherapy/guided imagery. All patients completed documentation of symptom frequency and severity using a 100mm visual analog scale (VAS) and assessment of health-related quality of life (BEST score) before and following therapy. Data were analyzed to determine comparative change in symptom burden between the two cohorts. Baseline demographics and symptom burden were similar between the two treatment subgroups. While patients improved with both multimodal and conventional therapies, BEST score demonstrated greater improvement with multimodal therapy (p=0.03). Physician perception of symptom burden at baseline and on follow-up did not correspond to self-reported questionnaire data. On multivariable analysis, multimodal therapy (OR 7.9, 95% CI 1.8-34.6, p=0.006) and functional esophageal disorders (OR 17.6, 95% CI 2.6-121.1, p=0.004) predicted >50% improvement in BEST score, while the presence of psychiatric disease was a negative predictor (OR 0.22, CI 0.05-0.94, p=0.04). Psychological intervention using multimodal therapy provides clinical value to the management of functional esophageal symptoms among patients refractory to conventional therapy.

Symptom burden and quality of life in patients with high-risk essential thrombocythaemia and polycythaemia vera receiving hydroxyurea or pegylated interferon alfa-2a: a post-hoc analysis of the MPN-RC 111 and 112 trials

Patients with essential thrombocythaemia or polycythaemia vera have several symptoms that can worsen their quality of life. We aimed to assess how symptom burden changes over time with cytoreductive therapy. We performed a post-hoc analysis of data from MPN-RC 111-a single-arm, open-label, phase 2, multicentre trial at 17 hospitals and cancer centres in Italy and the USA, evaluating the clinical-haematological response to pegylated interferon alfa-2a in patients who were resistant or intolerant to hydroxyurea (NCT01259817)-and MPN-RC 112-a randomised, open-label, phase 3, multicentre trial at 25 hospitals and cancer centres in France, Germany, Israel, Italy, the UK, and the USA, comparing the clinical-haematological response to pegylated interferon alfa-2a versus hydroxyurea in therapy-naive patients with either high-risk essential thrombocythaemia or polycythaemia vera (NCT01258856). Patients completed the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) and the European Organisation for the Research and Treatment of Cancer Core Quality of Life Questionnaire through 12 months after initiation of treatment as secondary endpoints. In this post-hoc analysis, we examined the association of symptom burden with the clinical-haematological response at 12 months and the effect of baseline symptom burden (ie, high burden [total symptom score ≥20] vs low burden [total symptom score <20]) on subsequent changes in symptoms, estimated via mixed models. A clinically significant improvement in symptom burden was defined as 50% or greater improvement in the MPN-SAF total symptom score from baseline to 12 months in patients with a total symptom score greater than zero at baseline. 135 patients were enrolled in MPN-RC 111 between Feb 15, 2012, and Dec 23, 2015, and 168 were enrolled in MPN-RC 112 between Sept 24, 2011, and June 30, 2016. For this analysis, we included data from 114 patients from MPN-RC 111 (64 [56%] with essential thrombocythaemia and 50 [44%] with polycythaemia vera; 56 [49%] were female, and 100 [91%] of 110 were white) and 166 patients from MPN-RC 112 (79 [48%] with essential thrombocythaemia and 87 [52%] with polycythaemia vera; 68 [41%] were female, and 145 [93%] of 156 were white). At 12 months, a clinically significant improvement in symptom burden was reported by 12 (32%) of 38 complete responders and seven (20%) of 35 partial responders treated with pegylated interferon alfa-2a in MPN-RC 111; five (19%) of 27 complete responders and six (18%) of 34 partial responders treated with pegylated interferon alfa-2a in MPN-112; and eight (27%) of 30 complete responders and six (22%) of 27 partial responders treated with hydroxyurea in MPN-112. More complete and partial responders reported a clinically significant improvement than did non-responders (44 [22%] of 191 complete and partial responders vs four [5%] of 76 non-responders; Fisher's exact p=0·0003). Symptom burden improved between 3 and 12 months in patients with high baseline symptom burden, both those treated with pegylated interferon alfa-2a (mean total symptom score change -10·2, 95% CI -13·2 to -7·2) and those treated with hydroxyurea (-6·8, -11·2 to -2·4). However, symptom burden worsened between 3 and 12 months in patients with low baseline symptom burden (patients treated with pegylated interferon alfa-2a: mean total symptom score change 3·2, 95% CI 0·9 to 5·4; patients treated with hydroxyurea: 3·4, 0·6 to 6·2). Results can inform treatment decisions, including treatment timing and goals in managing essential thrombocythaemia and polycythaemia vera, because measuring symptom burden from the patient perspective is crucial to understanding treatment efficacy and tolerability. US National Cancer Institute of the National Institutes of Health, and Roche Genentech.

Exploring Genotype:Phenotype Correlations at Baseline and at One Year for ET and PV Patients in the Majic Study

Exploring Genotype:Phenotype Correlations at Baseline and at One Year for ET and PV Patients in the Majic Study

Heart Rate Monitor Agreement In Breast Cancer Survivors In A Community-based Exercise Program

Appropriate exercise intensity, often expressed as target heart rate (HR), is critical to effecting change in symptom burden in breast cancer survivors (BCS). Traditional chest-worn monitors, despite their well-documented validity, may be inconvenient in unsupervised settings due to necessary receivers and participant discomfort. Commercially-available wearable sensors may represent an accessible alternative to HR monitoring in community-based exercise settings. PURPOSE: To examine the agreement between the Fitbit Inspire HR and Polar chest monitor for HR measurement in BCS at different stages of exercise in a community-based program. METHODS: BCS (N = 9; aged 38-72 years) were randomized to a 12-week moderate intensity (45-75% HR reserve) pilot aerobic exercise program. HR was concurrently measured using a Polar chest strap monitor and wrist-worn Fitbit Inspire HR in 5 stages: pre-exercise seated rest; midpoint of a 5-minute warmup; midpoint of moderate intensity exercise; midpoint of a 5-minute cool-down; after a 5-minute seated recovery. Agreement between HR measurements was assessed using Lin’s concordance correlation coefficient (rc). Relative error rates were calculated to indicate differences across exercise session stages. RESULTS: Across sessions (n = 187), HR ranged from 55 to 139 beats per minute. Agreement between the Polar monitor and Fitbit Inspire HR was highest during seated rest (pre-exercise, rc = 0.74, 95%CI [0.67, 0.80]; post-exercise, rc = 0.90, 95%CI [0.86, 0.92]) followed by the midpoint of moderate intensity exercise (rc = 0.63, 95%CI [0.54, 0.70]). Agreement was lowest during “transitionary” periods—i.e., warmup (rc = 0.37, 95% [0.25, 0.49]) and cool-down (rc = 0.43, 95% [0.32, 0.53]). Mean relative error rates ranged from -4.30% to 3.27% and were greatest during the warmup stage (RER = -4.3 ± 12.06%). CONCLUSION: This study provides novel data on HR monitor agreement in a community-based exercise setting and in a clinical population. Results indicate moderate agreement between Fitbit Inspire HR and Polar HR monitors during steady-state, moderate intensity aerobic exercise. While Fitbit alone may provide an estimate of exercise HR, it is likely not precise enough for accurate HR monitoring in exercise prescription.

Interim Phase 2 Clinical Trial Results for LCL161, an Oral Smac Mimetic, in Patients with Intermediate or High Risk Myelofibrosis

Interim Phase 2 Clinical Trial Results for LCL161, an Oral Smac Mimetic, in Patients with Intermediate or High Risk Myelofibrosis

Differences by race in patient-reported symptoms during chemotherapy among women with early-stage, hormone receptor-positive breast cancer.

6528 Background: Symptom burden may contribute to racial differences in cancer treatment adherence and survival. Evidence on changes in symptom burden during chemotherapy and whether these differ by race is scarce. We used patient reported outcomes data collected before and after breast cancer chemotherapy initiation to compare symptom burden by race. Methods: Using electronic medical records of a large cancer center in the southern region of the US, we identified Black and White women diagnosed with stage I-III, hormone-receptor positive breast cancer from January 2007 to December 2015. A tablet-based platform [ConcertAI] was used to collect patient reported symptoms at the point of care. We included patients with at least one completed symptom report before and during chemotherapy. We focused on two standardized composite scores – physical symptoms and treatment side-effect (mean of 50 and standard deviation of 10), and calculated changes in symptoms using the closest report before chemotherapy and the most severe score reported during chemotherapy. Patients with a 10-point increase were classified as having a clinically meaningful increase in symptom burden. We used Oaxaca-Blinder decomposition to quantify racial differences in symptom burden change explained by baseline characteristics. These included baseline symptom scores, sociodemographic characteristics (age, regional level household income and education, state) and clinical characteristics (cancer stage and primary chemo regimen). Results: Among 1,167 included patients, Black women (30%) were younger (52 vs. 55 years old, p&lt;.001), more likely to live in areas with lower median household income and less education, and reported most severe scores about 2 weeks later than White women ( p&lt;.05). They were also more likely to report a 10-point increase in symptom burden for physical (68.5% vs. 61.2%, p=.017) and side-effects symptoms score (49.0% vs. 41.4%, p=.015). This was driven by larger increases in selected individual symptoms among Black women, such as sweating, itching, and numbness (under physical symptom score), and hair loss and taste change (under side-effect score). Decomposition analyses showed that baseline characteristics (especially primary chemo regimen) explained 79.2% ( p=.002) and 35.2% ( p=.131) of the increased probability of Black women reporting a 10-point increase in physical symptom and side-effects scores respectively. Conclusions: Black women with early-stage breast cancer were more likely to report a clinically meaningful increase in treatment side-effects and physical symptoms during chemotherapy compared to White women. Differences by race in physical symptoms scores were mostly explained by baseline characteristics. Future studies should examine whether racial differences in symptom burden translate into differences in treatment adherence and mortality.

Treatment effects of palliative care consultation and patient contentment: A monocentric observational study.

Palliative care is a central component of the therapy in terminally ill patients. During treatment in non-palliative departments this can be realized by consultation.To analyze the change in symptom burden during palliative care consultation.In this observational study, we enrolled all cancer cases (n = 163) receiving inpatient treatment for 2015 to 2018 at our institution. We used the MDASI-questionnaire (0 = ‘not present’ and 10 = ”as bad as you can imagine”) and the FAMCARE-6 (1 = very satisfied, 5 = very dissatisfied) to analyze the treatment effect and patient satisfaction, respectively.We examined the association of symptom burden and patient satisfaction using Spearman-correlation. Comparing mean values, we applied the Wilcoxon-test and one-way ANOVA.An improvement in MDASI-core-items after treatment completion was significant (P < .05) in 14/18 symptoms. The change in perception of pain showed the strongest improvement (median: 5 to 3). Initially the MDASI-items “activity” (median = 8) and emotional distress (median = 5 and 6) were viewed as especially incriminating. There was no evidence for a correlation between patients’ age, the type of diagnosis and time since diagnosis.The analysis of FAMCARE-6 patient contentment was lower or equal to two in all of the six items. There was a weak negative association between the change in symptom burden of psycho-emotional items “distress/feeling upset” (P = .006, r Sp = −0,226), “sadness” and patient satisfaction in FAMCARE-6.A considerable improvement of the extensive symptom burden particularly of pain relief was achieved by integrating palliative consultation in clinical practice.

Symptom Burden and Quality of Life in High-Risk Essential Thrombocythemia and Polycythemia Vera Patients Receiving Hydroxyurea or Pegylated Interferon Alfa-2a: Results of Myeloproliferative Neoplasms Research Consortium (MPN-RC) 111 and 112 Trials

Symptom Burden and Quality of Life in High-Risk Essential Thrombocythemia and Polycythemia Vera Patients Receiving Hydroxyurea or Pegylated Interferon Alfa-2a: Results of Myeloproliferative Neoplasms Research Consortium (MPN-RC) 111 and 112 Trials

Symptom Evolution in Patients with Esophageal and Gastric Cancer Receiving Palliative Chemotherapy: A Population-Based Study.

Palliative chemotherapy (PC) is associated with a modest survival benefit in patients with incurable esophageal and gastric cancer; however, changes in symptom profile during treatment are not well described. Understanding the trajectory of symptoms during treatment may lead to improved care and facilitate shared decision making. In this study, we address this knowledge gap among all patients receiving PC in the Canadian province of Ontario. Patients diagnosed with incurable esophageal and gastric cancer who received PC from 2012 to 2017 were identified from the Ontario Cancer Registry. Patients with one or more recorded Edmonton Symptom Assessment System (ESAS) scores in the 12months following cancer diagnosis were included. The ESAS includes scores from 0 to 10 in nine domains (anxiety, depression, drowsiness, lack of appetite, nausea, pain, shortness of breath, tiredness, and lack of well-being). Symptom severity is categorized as none-mild (≤ 3), moderate (4-6), or severe (7-10). We focused on potentially modifiable symptoms, i.e. nausea, pain, and anxiety/depression. Logistic regression was used to identify factors associated with moderate-severe ESAS scores in these domains. Among those patients with serial ESAS scores (at 8 ± 2 and 12 ± 2weeks) receiving chemotherapy, we describe changes during treatment (decrease by ≥ 1 = improved; - 1 > 0 > 1 = unchanged; increase by ≥ 1 = deteriorated). The cohort included 1900 patients who received PC, of whom 79% (1497/1900) had one or more recorded ESAS scores. In multivariate analysis, younger patients were more likely to have moderate-severe scores in nausea (odds ratio [OR] 1.89, 95% confidence interval [CI] 1.23-2.90 [p < 0.01] in patients aged 41-50years compared with patients aged ≥ 71years) and pain (OR 1.88, 95% CI 1.36-2.60 [p < 0.01] in patients aged 51-60years compared with patients aged ≥ 71years). Compared with males, females were more likely to report moderate-severe scores in anxiety/depression (OR 1.58, 95% CI 1.21-2.08 [p < 0.01]). At 8 ± 2weeks from PC initiation, symptom scores were unchanged in 19-42% of patients, improved in 30-51% of patients, and deteriorated in 17-35% of patients. The greatest change in symptom burden was observed for appetite (51% improvement) and anxiety/depression (35% deterioration). Similar trends were observed at 12 ± 2weeks. In this large, population-based study, we observed that younger patients were more likely to report moderate-severe symptoms in pain and nausea, and females were more likely to report moderate-severe symptoms in anxiety/depression. Anxiety/depression symptoms become increasingly problematic for a substantial proportion of patients receiving PC. Supportive care efforts to mitigate these symptoms in routine practice are needed.

Validation of the Binocular Vision Dysfunction Questionnaire (BVDQ).

Among patients presenting with dizziness, visual dysfunction must be considered, including vertical heterophoria (VH), a frequently under-identified form of binocular vision dysfunction where there is vertical discrepancy between the lines of sight of the eyes when at physiologic rest. Current self-rated screening measures do not account for complex VH symptomatology including dizziness/ambulation difficulties, nausea, headache, anxiety, neck pain, and reading impairment. VH must be differentiated from vestibular/otolithic etiologies, as their treatment frequently provides inadequate relief, yet treatment of the VH can reduce/eliminate symptoms. The objective of this study is to create a valid measurement tool (binocular vision dysfunction questionnaire) to assist in identifying VH among dizzy patients to aid in appropriate referral. Retrospective case series. Tertiary referral center. One hundred twenty-six patients presenting to an optometric binocular vision subspecialist diagnosed with VH. Psychometric study. The measurement tool's internal consistency and test-retest reliability was assessed. Confirmatory and exploratory factor analyses were performed. Validity was estimated through correlations with a visual analog scale and validated instruments for headaches, dizziness, and anxiety. Excellent reliability demonstrated including Cronbach's alpha of 0.91 and high test-retest reliability. Statistical correlations with established measurements established sound convergent/content validity. Analysis of participants who underwent treatment indicated change in BVDQ score correlates with perception of change in symptom burden. Results suggest the BVDQ is a valid, reliable screening tool to assist otologists in identifying VH among their dizzy patients. The BVDQ may also be useful for measuring changes with various treatments, and in identifying diverse symptoms associated with BVD/VH.

Symptom Burden and Unmet Support Needs of Patients With Parkinson's Disease: A Cross-Sectional Study in Asia-Pacific Regions

ObjectivesSupport care is rarely assessed and offered to people with long-term neurologic conditions, particularly Parkinson's disease. This study aimed to assess the symptom burden and unmet support care needs in people with mild to severe Parkinson's disease. DesignCross-sectional study. Setting and ParticipantsPatients with Parkinson's disease were recruited from neurologic outpatient clinics from 3 East and Southeast Asian regions, including Hong Kong, Taiwan, and Thailand. MethodsA standardized set of questionnaires assessing unmet care needs [Palliative care Outcome Scale (POS)], disease-specific symptom burden (POS–Symptoms–Parkinson's Disease), generic health-related quality of life (HRQOL) (EQ-5D-3L), and sociodemographic and clinical background. ResultsCompleted questionnaires (n = 186) were collected from 64 Hong Kong Chinese, 64 Taiwanese, and 58 Thai patients. Their mean age was 67.23 ± 8.07, 54% were female, and 80% had mild-to-moderate disease. Their mean POS score was 10.48 ± 6.38, indicating moderate unmet support needs. Two-thirds of the participants rated constipation, fatigue, leg problem, and daytime somnolence as the most prevalent and burdensome symptoms. Patients from Hong Kong and Taiwan prioritized psychosocial and spiritual support, whereas Thai patients prioritized physical needs and emotional concerns. Multivariate adjustment for demographics and clinical characteristics showed that high psychological, spiritual, and practical burdens are associated with young age, male gender, and advanced disease stages. Conclusions and ImplicationsPatients experience significant symptom burden and moderate unmet support needs at the early to middle stage of Parkinson's disease. Routine assessment of changes in symptom burden should start early. The timely referral of support care services should provide appropriate psychospiritual and practical support in addition to motor training. Planning for support care services should consider cultural and health service contexts.

Symptom burden trajectories experienced by patients with brain tumors.

Survivors of childhood brain tumors experience persistent health concerns across their lifespan. In the current study, the authors evaluated changes in symptom burden over the course of 12months using pediatric Patient-Reported Outcomes Measurement Information System (PROMIS) measures. Data from 202 survivors aged 8 to 21years and 262 parents of survivors who were aged 5 to 21years were analyzed. All completed a PROMIS Cognition short form and computerized adaptive tests of pediatric Anxiety, Depressive Symptoms, Fatigue, Mobility, Upper Extremity Function, and Peer Relationships. Approximately one-half of participants (223 participants: 97 survivors of childhood brain tumors and 126 parents) completed the 12-month follow-up. Linear mixed-effects models evaluated group-level symptoms over time. Cox proportional hazard models explored whether symptoms predicted survival, and latent class growth analysis investigated patterns of individual-level symptom changes over time. Linear mixed-effects models demonstrated that patient-reported Cognition and parent-reported Anxiety worsened over time. Latent class growth analysis results indicated that patient and parent reports diverged, both with regard to the number of classes identified and in the trends of these classes. Parents and patients reported similar patterns of depression over time. For the other areas, parents either were more likely to observe different patterns (Peer Relationships and Mobility) or less likely to observe different patterns (Upper Extremity Function, Cognition, Anxiety, and Fatigue). Baseline patient-reported Mobility and Upper Extremity Function were found to be associated with survival. Survivors of childhood brain tumors demonstrated different trajectory patterns of symptom burden. Along with baseline functioning status and days since treatment, patient-reported Mobility and Upper Extremity Function were associated with survival, suggesting a possible role for patient-reported outcomes in clinical care, especially individualized, tailored assessments such as PROMIS.

Virtual Reality Use for Symptom Management in Palliative Care: A Pilot Study to Assess User Perceptions.

In the past two decades, virtual reality (VR) technology has found use in a variety of clinical settings including pain management, physical medicine and rehabilitation, psychiatry, and neurology. However, little is known about the utility of VR in the palliative care setting. Moreover, previous investigations have not explored user perceptions of the VR experience in this population. Understanding user perceptions of the VR intervention will be critical for the development and delivery of effective VR therapies. To examine the utility of VR for palliative care patients, a pilot study of VR use was conducted with 12 adult patients diagnosed with life-limiting illness who were residents at a free-standing hospice facility. The intervention consisted of a one-time 30-minute VR experience. User perceptions were assessed through both quantitative and qualitative means, including participant responses to open-ended questions after the VR intervention. Acute changes in symptom burden were assessed using the revised Edmonton Symptom Assessment Scale. Participants found the VR experience to be both enjoyable and useful, and the intervention was well-tolerated overall. This study provides support for VR as a promising new therapeutic modality for patients undergoing palliative care.

The General Symptom Questionnaire-30 (GSQ-30): A Brief Measure of Multi-System Symptom Burden in Lyme Disease.

Introduction: The multi-system symptoms accompanying acute and post-treatment Lyme disease syndrome pose a challenge for time-limited assessment. The General Symptom Questionnaire (GSQ-30) was developed to fill the need for a brief patient-reported measure of multi-system symptom burden. In this study we assess the psychometric properties and sensitivity to change of the GSQ-30.Materials and Methods: 342 adult participants comprised 4 diagnostic groups: Lyme disease (post-treatment Lyme disease syndrome, n = 124; erythema migrans, n = 94); depression, n = 36; traumatic brain injury, n = 51; healthy, n = 37. Participants were recruited from clinical research facilities in Massachusetts, Maryland, and New York. Validation measures for the GSQ-30 included the Patient Health Questionnaire-4 for depression and anxiety, visual analog scales for fatigue and pain, the Sheehan Disability Scale for functional impairment, and one global health question. To assess sensitivity to change, 53 patients with erythema migrans completed the GSQ-30 before treatment and 6 months after 3 weeks of treatment with doxycycline.Results: The GSQ-30 demonstrated excellent internal consistency (Cronbach α = 0.95). The factor structure reflects four core domains: pain/fatigue, neuropsychiatric, neurologic, and viral-like symptoms. Symptom burden was significantly associated with depression (rs = 0.60), anxiety (rs = 0.55), pain (rs = 0.75), fatigue (rs = 0.77), functional impairment (rs = 0.79), and general health (rs = −0.58). The GSQ-30 detected significant change in symptom burden before and after antibiotic therapy; this change correlated with change in functional impairment. The GSQ-30 total score significantly differed for erythema migrans vs. three other groups (post-treatment Lyme disease syndrome, depression, healthy controls). The GSQ-30 total scores for traumatic brain injury and depression were not significantly different from post-treatment Lyme disease syndrome.Conclusions and Relevance: The GSQ-30 is a valid and reliable instrument to assess symptom burden among patients with acute and post-treatment Lyme disease syndrome and is sensitive in the detection of change after treatment among patients with erythema migrans. The GSQ-30 should prove useful in clinical and research settings to assess multi-system symptom burden and to monitor change over time. The GSQ-30 may also prove useful in future precision medicine studies as a clinical measure to correlate with disease-relevant biomarkers.

2484. Patient Reported Outcomes After Switching to a 2-Drug Regimen of Dolutegravir + Rilpivirine: Week 148 Results from the Sword-1 and Sword-2 Studies

BackgroundThe SWORD-1 and SWORD-2 studies previously demonstrated that high rates of virologic suppression were maintained for 148 weeks after switching virologically suppressed HIV-1 infected adults from their current 3- or 4-drug antiretroviral regimen (CAR) to the 2-drug regimen (2DR) of dolutegravir + rilpivirine on Day 1 (Early Switch (ES) DTG+RPV group). This abstract reports the pooled SWORD-1/2 results of patient reported outcomes (PRO) measures through Week 148.MethodsHIV Treatment Satisfaction Questionnaire (HIVTSQ) and Symptom Distress Module (SDM) were secondary PRO endpoints in the SWORD trials. For HIVTSQ, high scores represent greater treatment satisfaction (range 0 to 60). SDM was assessed using the Symptom Bother Score with low values indicating less symptom bother (range 0 to 80). The EQ-5D-5L measure of general health status was assessed as an exploratory endpoint with maximum utility score of 1 to indicate perfect health. Change from Baseline in these endpoints was calculated for the ES subjects (over 148 weeks). Subjects randomized to CAR switched to DTG+RPV at Week 52 (Late Switch (LS) DTG+RPV group) and change from LS Baseline (i.e., last pre-switch assessment) was calculated (over 96 weeks).ResultsLow Symptom Bother (9.6 and 10.3) and high TSQ scores (54.4 and 54.3) were reported pre-switch in the ES and LS groups, respectively.ES subjects reported modest improvements from Baseline in both symptom burden and overall treatment satisfaction in all visits through Week 148 (Figures 1 and 2). Among the LS group, there was little change in symptom burden but similar improvement in treatment satisfaction. Pre-switch health status was high in ES and LS groups (EQ-5D mean utility: 0.96 and 0.94, respectively) and remained stable in both groups at all time points.ConclusionHigh treatment satisfaction and low symptom burden that were observed in patients under CAR were maintained long term after switching to DTG+RPV. These results corroborate DTG+RPV as a well-tolerated 2DR alternative treatment option in patients currently suppressed on other 3/4-drug regimens without previous virologic failure. Disclosures All authors: No reported disclosures.

Factors related to health-related quality of life in older people with multimorbidity and high health care consumption over a two-year period

BackgroundThe prevalence of multimorbidity is increasing worldwide, and older people with multimorbidity are frequent users of health care services. Since multimorbidity has a significant negative impact on Health-related Quality of Life (HrQoL) and is more common in older age it would be expected that factors related to HrQoL in this group might have been thoroughly researched, but this is not the case. Furthermore, it is important to look at old people living at home, considering the shift from residential to home-based care. Therefore, we aim to investigate factors that are related to HrQoL in older people with multimorbidity and high health care consumption, living at home.MethodsThis is a secondary analysis of a RCT study conducted in a municipality in south-eastern Sweden. The study had a longitudinal design with a two-year follow-up period assessing HrQoL, symptom burden, activities of daily living, physical activity and depression.ResultsIn total, 238 older people with multimorbidity and high health care consumption, living at home were included (mean age 82, 52% female). A multiple linear regression model including symptom burden, activities of daily living and depression as independent variables explained 64% of the HrQoL. Higher symptom burden, lower ability in activities of daily living and a higher degree of depression were negatively related to HrQoL. Depression at baseline and a change in symptom burden over a two-year period explained 28% of the change in HrQoL over a two-year period variability. A higher degree of depression at baseline and negative change in higher symptom burden were related to a decrease in HrQoL over a two-year period.ConclusionIn order to facilitate better delivery of appropriate health care to older people with high health care consumption living at home it is important to assess HrQoL, and HrQoL over time. Symptom burden, activities of daily living, depression and change in symptom burden over time are important indicators for HrQoL.Trial registrationClinicaltrials.gov identifier: NCT01446757, the trial was registered prospectively with the date of trial registration October 5th, 2011.