Frequency and distribution of gastrointestinal oncology patient-reported symptomatic adverse events (SAEs) at a comprehensive cancer center.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 463-463
Author(s):  
Nadine Jackson McCleary ◽  
Ellana Haakenstad ◽  
Jessica Cleveland ◽  
Sunyi Zhang ◽  
Michael J. Hassett ◽  
...  

463 Background: In clinical trials, the systematic collection of patient (pt) reported outcomes has been shown to improve quality of life & overall survival. To develop predictive care models for symptom management, we explored the frequency & distribution of SAEs reported by pts who reported electronic patient reported outcomes (ePRO) prior to outpatient visits to the Gastrointestinal Cancer Center (GCC) at Dana Farber Cancer Institute (DFCI). Methods: ePRO is a modified NCI Patient Reported Outcomes – Common Terminology Criteria for Adverse Events instrument distributed weekly to GCC pts with a medical/surgical/radiation oncology encounter. Responses are available to the care team in the electronic health record. ePRO consists of presence/frequency/severity/interference of 15 core SAEs (fatigue, insomnia, general pain, decreased appetite, nausea, vomiting, constipation, diarrhea, shortness of breath, numbness and tingling, rash, concentration, fever, anxiety, sadness). Responses are scored 0 to 3 (with 2 and 3 indicating moderate and severe SAEs, respectively). We examined the frequency & distribution of grade 2 and 3 SAEs in ePRO responders by age, gender, race/ethnicity. All pts had gastrointestinal cancer and an outpatient visit for treatment, symptom management, follow-up care. Results: From 9/1/2018 to 8/31/2020, 1912 unique pts responded (response rate 23%). Most respondents were age 50-69 years (58% compared to 15% age <50, 27% age ≥70; range 18-95), male (53%), white (75%). Grade 3 SAE frequencies were pain (12%), fatigue (11%), anxiety/constipation/insomnia/decreased appetite (5%), sadness/numbness and tingling/diarrhea (3%), concentration/shortness of breath (2%), nausea/rash (1%), fever/vomiting (0%). Across pts, fatigue, general pain, insomnia, anxiety were the most common grade 2 and 3 SAEs. Shortness of breath, vomiting, rash, fever were least common (Table). Conclusions: In GCC pts responding to ePRO, the most frequent SAEs were pain, fatigue, insomnia, anxiety. Shortness of breath, nausea, vomiting, diarrhea were less often severe. Pts <50 were more likely to report severe anxiety but there were no other major differences based on age, sex, race/ethnicity. Ongoing efforts will increase pt/provider engagement and develop predictive models & symptom management interventions from ePRO responses. [Table: see text]

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19117-e19117
Author(s):  
Jessica Cleveland ◽  
Michael J. Hassett ◽  
Sherry Lee ◽  
Isaac S. Chua ◽  
Laura Stewart Dominici ◽  
...  

e19117 Background: Systematic review of electronic patient reported outcomes (ePRO) has been shown to improve quality of life and overall survival in clinical trial. We previously demonstrated feasibility of ePRO across Dana-Farber Cancer Institute (DFCI). We sought to examine the distribution and frequency of first symptomatic adverse events (SAEs) among ePRO responders in ambulatory oncology practice. Methods: The ePRO tool uses the validated NCI developed Patient Reported Outcomes – Common Terminology Criteria for Adverse Events (PRO-CTCAE) instrument to assess attributes of 15 core SAEs (fatigue, insomnia, general pain, decreased appetite, nausea, vomiting, constipation, diarrhea, shortness of breath, numbness and tingling, rash, concentration, fever, anxiety, sadness) selected by clinician stakeholders and deployed via any internet-enabled device once every 7 days. Responses are viewable in the EHR, scored 0 to 3 using an algorithm, with scores of 3 highlighted to indicate severe grade SAEs. Results: We examined the distribution and frequency of the first 5183 unique ePRO reports for unselected patients seen in the medical, radiation and surgical oncology outpatient clinics of four pilot multidisciplinary clinics (Breast, Genitourinary, Gastrointestinal and Head and Neck) between September 2018-December 2019. Twenty one percent of eligible patients responded to ePRO (5183 of 26,084). Most respondents were female (59%), Caucasian (89%), and age 50-69 years (56% compared to 16% age <50 years, 28% age ≥70; range 19-98 years). The frequency of grade 3 SAEs was pain (10%), fatigue (6%), insomnia (4%), constipation (3%), numbness and tingling/concentration/anxiety/decreased appetite (2%), diarrhea/shortness of breath/sadness (1%), and rash/fever/nausea/vomiting (none) (Table). Conclusions: We observed a consistent distribution of SAEs across cancer types, age and sex. The most frequently reported SAEs are those clinicians struggle to treat with medications - pain, fatigue, insomnia and anxiety. Research to develop effective strategies to address this constellation of SAEs should be prioritized. [Table: see text]


2017 ◽  
Vol 8 (3) ◽  
pp. 395-402 ◽  
Author(s):  
Gabriel Lopez ◽  
Jennifer McQuade ◽  
Lorenzo Cohen ◽  
Jane T Williams ◽  
Amy R Spelman ◽  
...  

2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 292-292
Author(s):  
Nadine Jackson McCleary ◽  
Deborah Schrag ◽  
Neil E. Martin ◽  
Sadiqa Mahmood ◽  
Elizabeth Beyer ◽  
...  

292 Background: Routine collection of patient reported outcomes (PROs) reduces hospitalizations and improves quality of life. In the absence of clear implementation guidelines and research guiding deployment, PROs may not have the desired impact on outcomes in routine oncology practice. We share lessons learned from PRO deployment at Dana-Farber Cancer Institute. Methods: We developed a symptom/toxicity assessment tool based on the PRO-CTCAE to capture 15 symptomatic adverse events with a 1-week recall: fatigue/ decreased appetite/insomnia/ shortness of breath/numbness and tingling/concentration, general pain/anxiety/sadness, rash, nausea/vomiting/fever, constipation, and diarrhea. Responses from eligible English-literate patients scheduled for a gastrointestinal cancer center or adult palliative care visit between January 18 to March 22, 2018 were transmitted directly from clinic tablet to the EMR. To evaluate the deployment, we sought qualitative feedback from clinic staff and three multidisciplinary working groups comprised of patients, nurses, pharmacists, operations leaders, quality/safety experts, and health services researchers to identify technical and workflow gaps in PRO Content, Implementation, and Analytics. Results: We noted a 38% response rate of the N = 4440 PROs assigned to N = 4440 scheduled visits for N = 2055 unique patients (36% were completed, 2% started but not completed); 62% were not started. Workflow enhancement requests include an updated summary view, a clinical documentation tool, a scoring algorithm to highlight severe responses, and a quality metric dashboard to evaluate the deployment. Ongoing analyses are studying the proportion of moderate-severe symptomatic adverse events reported and their association with provider action (i.e., supportive care referral, chemotherapy treatment plan modification, or unplanned ED/hospitalization in the subsequent 30 days). Conclusions: Refinement of the PRO deployment strategy is needed to guide implementation efforts and demonstrate meaningful impact in routine oncology practice.


2016 ◽  
Vol 34 (15_suppl) ◽  
pp. e21579-e21579
Author(s):  
Amy Ng ◽  
Diane D Liu ◽  
Swati Bansal ◽  
Janet L. Williams ◽  
Jack Brian Fu ◽  
...  

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 173-173
Author(s):  
Akina Natori ◽  
Vandana Devika Sookdeo ◽  
Tulay Koru-Sengul ◽  
Matthew Schlumbrecht ◽  
Carmen Calfa ◽  
...  

173 Background: Electronic health record (EHR) integrated symptom monitoring using patient reported outcomes (PRO) has been associated with improved outcomes, including health-related quality of life (HRQoL), in cancer survivors. However, these improvements have been documented through reasonably high completion rates of PRO measures in predominantly non-Hispanic White patient populations using only English language assessments. This study aimed to 1) examine factors associated with the completion of PRO assessments and 2) test differences in referrals to cancer support services between PRO responders and non-responders in a cohort of cancer survivors with significant racial, ethnic, and primary language diversity. Methods: A retrospective analysis (October 2019-February 2021) was performed for patients who were assigned the My Wellness Check (MWC) program at a tertiary, comprehensive cancer center. MWC is an EHR-based PRO assessment and referral program that uses PROMIS computer adaptive tests for depression, anxiety, pain, fatigue, and physical function as well as a psychosocial needs assessment. MWC PRO questionnaire is available in English or Spanish based on patient preference. Demographic and clinical characteristics of patients were collected and incorporated in multivariable binary logistic regression model to examine factors associated with completion of the MWC PRO questionnaires. The frequency of referrals to cancer support services was compared by Chi-square test between MWC PRO responders and non-responders. Adjusted odds ratio (aOR) and 95% confidence interval (95%CI) were calculated. Results: Of the 5306 patients eligible to complete MWC PRO questionnaire, the majority were female (64.1%), White (86.9%), Hispanic (65.8%), English speaker (55.4%), and 46.0% were responders. Patients who were younger than 65 (aOR 1.39; 95%CI 1.22-1.59; p < 0.0001), female (1.23; 1.09-1.41; p = 0.0019), non-Hispanic/Latino (1.43; 1.25-1.64; p < 0.0001), living with partners ( = 1.28; 1.13-1.46; p = 0.0001), and receipt of active treatment (1.37; 1.18-1.58; p < 0.0001) were significantly associated with MWC PRO completion. Responders were referred to cancer support services more often than non-responders (16.6% vs 5.4%, p < 0.0001). Conclusions: Patient-level and clinical factors predict completion of PRO measures, and responders were more likely to have a referral to cancer support services. To optimize supportive care for ambulatory cancer patients, further research is needed to identify factors that can promote patient engagement, particularly in patients who are under-utilizers of such services.


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 8515-8515 ◽  
Author(s):  
E. M. Basch ◽  
T. McDonough ◽  
A. Iasonos ◽  
E. Siegel ◽  
A. Culkin ◽  
...  

8515 Background: During NCI-sponsored clinical trials, clinicians elicit and report patient toxicity symptoms using the Common Terminology Criteria for Adverse Events (CTCAE). Alternatively, patients may be able to report this information directly, but it remains unclear how these patient reported outcomes (PROs) compare to clinician reports. Methods: Language from the CTCAE version 3 was adapted for patient self-reporting and pilot tested to assure comprehension. Then, a paper questionnaire containing 12 common CTCAE symptoms was administered to consecutive outpatients and their clinicians (physicians and nurses) in clinics specializing in lung or genitourinary malignancies at a specialty cancer center. Results: Between March and May 2005, 435 patients and their clinicians were approached in order to obtain 400 completed paired surveys. For most symptoms agreement was high and this was especially true for more observable symptoms (vomiting, diarrhea) compared to more subjective areas (fatigue, dyspnea) (Table). Most discrepancies were within one point. Only rarely would differences have altered treatment decisions (grade <2 vs. ≥3). Patients more commonly assigned greater severity than clinicians. There was no significant difference when patients reported before versus after caregivers. Kappa values did not accurately measure agreement due to asymmetry in the marginal distribution of scores. Conclusion: Patients and clinicians generally agree on CTCAE symptom severity. Future research should examine the impact of symptom PROs on clinical outcomes and the use of real-time reporting for early detection of SAEs. [Table: see text] No significant financial relationships to disclose.


2016 ◽  
Vol 34 (15_suppl) ◽  
pp. e21690-e21690
Author(s):  
Gabriel Lopez ◽  
Jennifer Leigh McQuade ◽  
Richard T. Lee ◽  
Bryan Fellman ◽  
Yisheng Li ◽  
...  

2011 ◽  
Vol 29 (8) ◽  
pp. 1029-1035 ◽  
Author(s):  
Donna L. Berry ◽  
Brent A. Blumenstein ◽  
Barbara Halpenny ◽  
Seth Wolpin ◽  
Jesse R. Fann ◽  
...  

Purpose Although patient-reported cancer symptoms and quality-of-life issues (SQLIs) have been promoted as essential to a comprehensive assessment, efficient and efficacious methods have not been widely tested in clinical settings. The purpose of this trial was to determine the effect of the Electronic Self-Report Assessment–Cancer (ESRA-C) on the likelihood of SQLIs discussed between clinicians and patients with cancer in ambulatory clinic visits. Secondary objectives included comparison of visit duration between groups and usefulness of the ESRA-C as reported by clinicians. Patients and Methods This randomized controlled trial was conducted in 660 patients with various cancer diagnoses and stages at two institutions of a comprehensive cancer center. Patient-reported SQLIs were automatically displayed on a graphical summary and provided to the clinical team before an on-treatment visit (n = 327); in the control group, no summary was provided (n = 333). SQLIs were scored for level of severity or distress. One on-treatment clinic visit was audio recorded for each participant and then scored for discussion of each SQLI. We hypothesized that problematic SQLIs would be discussed more often when the intervention was delivered to the clinicians. Results The likelihood of SQLIs being discussed differed by randomized group and depended on whether an SQLI was first reported as problematic (P = .032). Clinic visits were similar with regard to duration between groups, and clinicians reported the summary as useful. Conclusion The ESRA-C is the first electronic self-report application to increase discussion of SQLIs in a US randomized clinical trial.


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