The effect of a lay health worker-led symptom assessment intervention for patients on patient-reported outcomes, healthcare use, and total costs.

2018 ◽  
Vol 36 (15_suppl) ◽  
pp. 6502-6502
Author(s):  
Manali I. Patel ◽  
David Ramirez ◽  
Richy Agajanian ◽  
Jay Bhattacharya ◽  
Arnold Milstein ◽  
...  
Keyword(s):  
Health Worker ◽  
Patient Reported Outcomes ◽  
Symptom Assessment ◽  
Healthcare Use ◽  
Lay Health Worker ◽  
Patient Reported

Prospective Validation of the Italian Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF: Italian) In 186 MPN Patients

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 5060-5060
Author(s):  
Robyn Scherber ◽  
Tiziano Barbui ◽  
Alessandro M. Vannucchi ◽  
Francesco Passamonti ◽  
Giovanni Barosi ◽  
...  
Keyword(s):  
Research Funding ◽  
Patient Reported Outcomes ◽  
Myeloproliferative Neoplasm ◽  
Office Visit ◽  
Symptom Assessment ◽  
Advisory Committees ◽  
Patient Reported ◽  
Eortc Qlq C30 ◽  
The Usa ◽  
Eortc Qlq

Abstract Abstract 5060 Background: The Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) is a concise instrument of patient reported outcomes (PRO) designed to assess the unique spectrum of symptoms present in the majority of patients (Mesa et. al. Cancer 2007). We sought to validate the Italian Translation of the MPN-SAF which addresses 19 separate symptoms reported by MPN patients. Methods: Translation: We utilized the standard practice of PRO translation in which 3 independent translations are created by 3 independent translators fluent in both languages. A fourth translator then discussed the translations with the other translators and a consensus translation was obtained. Validation: Patients self completed the MPN-SAF: Italian at the time of a physician office visit and the Italian EORTC-QLQ-C30 (a widely used instrument of PRO for cancer patients) was co-administered for validation purposes. Results: Patients and Symptomatic Burden: 186 patients were prospectively enrolled (ET (N=88; 47%), PV (N=69; 37%) and MF (N=29; 16%)) a median of 6 years (range:0-29) from their diagnosis. Patients were of a median age (62; range 29–91 years) and gender (56% females) typical of the disease. 72% (N=135) had received some form of non-aspirin medical therapy for their disease, and 68% were on therapy at the time of completing the questionnaire. Patients frequently had a history of either thrombotic events (31%) and/or hemorrhagic events (13%). The MPN-SAF measured 19 items in the enrolled patients (data summarized in Table 1). Validation Analysis: EORTC-QLQ-C30: Consistent with our experience with the MPN-SAF:English, Pearson correlations between MPN-SAF:Italian individual symptom scores and the Italian EORTC-QLQ C30 showed excellent correlations with co-validation questions including fatigue, pain, insomnia, (all p<0.001). Excellent correlations were demonstrated between EORTC-QLQ-C30 subscales and corresponding MPN-SAF measurements. Comparison with MPN-SAF:English: Comparison with 102 patients prospectively completing the MPN-SAF: English (ET=20, PV=23, MF=59) in the USA indicated very strong correlations (when controlling for MPN subtype) in the prevalence of all 19 items assessed and only subtle differences in terms of symptomatic severity for fatigue, itching and insomnia. Conclusions: The MPN-SAF:Italian is an easy to administer, clear, 19-item inventory of patient-reported outcomes that is specific to MPNs. Additionally, the instrument is validated by 1) comparison to previously validated Italian instruments and 2) the correlation with the MPN-SAF:English. Utilization of the instrument in Italian MPN clinical trials will allow for useful comparison to patients completing the MPN-SAF in other countries and will serve as a valuable clinical marker of disease symptom severity. Disclosures: Vannucchi: Novartis: Membership on an entity's Board of Directors or advisory committees. Mesa:SBio: Research Funding; Novartis: Research Funding; Celgene: Research Funding; Incyte: Research Funding; Roche: Research Funding; eisai: Research Funding; telik: Research Funding.

Utilizing patient reported outcomes for patients recieving oral chemotherapy.

2017 ◽  
Vol 35 (8_suppl) ◽  
pp. 190-190 ◽  
Author(s):  
Emily R. Mackler ◽  
Kathleen W. Beekman ◽  
Laura Bushey ◽  
Anne Gentz ◽  
Kathleen Davis ◽  
...  
Keyword(s):  
Side Effects ◽  
Side Effect ◽  
Patient Reported Outcomes ◽  
Symptom Burden ◽  
Symptom Assessment ◽  
Oral Chemotherapy ◽  
Severe Side Effect ◽  
Management Support ◽  
Patient Reported ◽  
Edmonton Symptom Assessment Scale

190 Background: Management of oral chemotherapy presents many challenges to oncology practitioners. The purpose of this study is to describe how incorporation of patient reported outcomes (PRO) for patients receiving oral chemotherapy can identify those patients who are experiencing moderate to severe symptom burden and nonadherence. Methods: As part of a statewide quality collaborative, we wished to improve our monitoring of patients receiving oral chemotherapy. The quality collaborative created a PRO assessment that includes a revised Edmonton Symptom Assessment Scale (ESAS), a single-item adherence question, reasons for nonadherence, the patient’s most bothersome symptom and questions related to patient confidence. Our medical assistants provide the assessment to the patient before each appointment. Results: Patients completing the PRO during the first 3 months (7/7/16 – 9/27/16) were evaluated. We had 32 assessments completed by 23 patients. The oral chemotherapy prescribed were capecitabine (48%), erlotinib (13%), temozolomide (13%), and not recorded (26%). Of the 29 completed ESAS assessments, 72% included at least 1 moderate side effect, and 48% included at least 1 severe side effect. 29% of patients reported low-moderate confidence to self-manage their symptoms. Less than excellent adherence (<80% adherence) was reported in 30% of patients with the most commonly reported reason being related to side effects or concerns about side effects. Conclusions: Use of PROs in our oral chemotherapy population identified a large proportion of patients experiencing moderate to severe side effects. Further assessment of how this compares to what patients report to their oncologist during their visits will be reviewed. In addition, we found that approximately 30% of our patients are nonadherent to their oral chemotherapy. This is consistent with recent publications. We plan to continue assessing patient outcomes and utilizing the data we collect to improve patient self-management support.

Enhancing community capacity to improve cancer care delivery and the effect on patient-reported outcomes, healthcare utilization and total costs of care.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6522-6522
Author(s):  
Manali I. Patel ◽  
David Ramirez ◽  
Richy Agajanian ◽  
Hilda H. Agajanian ◽  
Jay Bhattacharya ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Health Plan ◽  
Cancer Care ◽  
Patient Reported Outcomes ◽  
Care Delivery ◽  
Mean Difference ◽  
Healthcare Use ◽  
Difference In Difference ◽  
Patient Reported ◽  
Over Time

6522 Background: To curb rising expenditures and improve patient-reported outcomes (PROs), we designed an intervention with patient, caregiver, provider, and payer input. The intervention is based on prior work using a lay health worker (LHW) to assess advanced cancer patients' symptoms. In this study, we trained the LHW to refer patients to palliative care and/or behavioral health services in response to positive assessments and expanded the intervention to all cancer stages. We implemented the intervention with a health plan and a community oncology group serving elderly racially/ethnically diverse patients to test the effect on symptoms, healthcare use, and total costs. Methods: We enrolled all newly diagnosed health plan beneficiaries with solid and hematologic malignancies from 10/2016 to 11/2017 and compared outcomes to all cancer patients diagnosed in the year prior to the intervention (control arm). Our primary outcome was change in patient-reported symptoms using the Edmonton Symptom Assessment Scale and Personal Health Questionnaire-9 at baseline, 6 and 12 months post-enrollment. Secondarily, we compared 12 month healthcare use and costs. All generalized linear regression models were adjusted for age, stage, comorbidities, diagnosis, and follow-up. Results: 425 patients were in the intervention; 407 in the control. In both groups, mean age was 79 years; 48% were non-Hispanic White, 43% Hispanic, 3% Black, 6% Asian/Pacific Islander; 60% had advanced stages; 28% had breast, 28% had gastrointestinal, and 10% had thoracic cancers. Intervention patients had significantly decreased symptom burden over time as compared with the control (Mean Difference: intervention (-0.77 +/- 0.28 p = 0.01) vs. control: (0.45 +/- 0.25 p = 0.06)); difference in difference: (-0.68 +/- 0.25 p = 0.007)). Depression scores also significantly decreased over time among intervention patients as compared with the control (Mean Difference: intervention (-1.10 +/- 0.38 p = 0.04)) vs control: (1.21 +/- 0.34 p = 0.01); (difference in difference: -2.03 +/- 0.3 p < 0.001)). As compared to the control arm, intervention patients had lower inpatient admissions (0.7 vs. 0.5 p = 0.01) and emergency department visits per thousand patients per year (0.6 vs. 0.42 p = 0.02), and lower median total healthcare costs ($32,270 versus $25,512 p = 0.01). Conclusions: An LHW intervention significantly improved patient-reported outcomes and the value of cancer care delivery and may be a solution to improve burdensome and costly care for patients.

Current Status of Patient-Reported Outcomes in Industry-Sponsored Oncology Clinical Trials and Product Labels

2007 ◽  
Vol 25 (32) ◽  
pp. 5087-5093 ◽  
Author(s):  
Kathleen Gondek ◽  
Pierre-Philippe Sagnier ◽  
Kim Gilchrist ◽  
J. Michael Woolley
Keyword(s):  
Clinical Trials ◽  
Patient Reported Outcomes ◽  
Symptom Assessment ◽  
Current Status ◽  
Cancer Therapies ◽  
Package Inserts ◽  
Patient Reported ◽  
Oncology Clinical Trials ◽  
Related Quality ◽  
The Impact

Assessing patient-reported outcomes (PROs) in clinical trials is of interest to clinicians, patients, regulators, and industry. The use and impact of PROs is a growing area of methodologic research, particularly as they relate to tumor types, biomarkers, and various patient populations and cultures. Both the US Food and Drug Administration (FDA) and European Agency for the Evaluation of Medicinal Products in recent guidance have acknowledged the need to account for treatment-related impact on patient symptoms and/or health-related quality of life (HRQOL). Clinical research likely reflects the informative value of PROs. A search of www.clinicaltrials.gov , the FDA Web site, and product package inserts was conducted to assess the inclusion of symptom assessment and HRQOL within industry-sponsored clinical trials in cancer and approved cancer therapies and their respective product labels. Overall, there were 2,704 industry-sponsored oncology trials, of which 322 (12%) included a PRO measure. Of the 70 FDA new or revised labels, only six package inserts include PRO data. Symptoms were assessed uniformly across the phases of clinical trials, whereas HRQOL assessment increased in the later phases of clinical trials. Collecting PRO data can enhance our understanding of cancer burden and the impact of interventions on patients' lives.

scholarly journals Patient Reported Outcomes in Penile Cancer

2021 ◽  
Author(s):  
Irini Youssef ◽  
Aasha Hoogland ◽  
Jad Chahoud ◽  
Philippe Spiess ◽  
Heather Jim ◽  
...  
Keyword(s):  
Symptom Score ◽  
Penile Cancer ◽  
Patient Reported Outcomes ◽  
Recurrent Disease ◽  
Symptom Burden ◽  
Symptom Assessment ◽  
Patient Reports ◽  
Patient Reported ◽  
Edmonton Symptom Assessment Scale ◽  
Partial Penectomy

Abstract Objective: Patient reports of their symptom burden (i.e., patient-reported outcomes or PROs) have been shown to direct clinicians’ ability to personalize care and improve outcomes. A disciplined assessment of PRO in the population of patients with penile cancer (PeCa) has not previously been undertaken. Our center has both a significant cadre of patients with PeCa and a significant experience with a well-established PRO: the Edmonton Symptom Assessment Scale (ESAS).Methods: After IRB approval, we screened ESAS surveys of 14,781 patients completed between 2/2017 and 2/2021. Of these, those with PeCa were divided into three cohorts: (A) Those after any partial penectomy procedure without lymph node dissection (LND); (B) Those after partial penectomy procedure with LND; and (C) Those after total penectomy and LND. Patients with recurrent disease were analyzed separately. ESAS scores were collated and compared both by individual symptom and cumulatively.Results: 22 PeCa patients completed 122 ESAS surveys in this time and are included in this analysis: a median of 4 ESAS surveys (mean=5, range=1-19) were completed by each patient. The symptom with the highest median ESAS score was Tiredness (3.00). Patients with recurrent disease had the highest cumulative symptom score (median score = 30). Patients after total penectomy with LND had a higher cumulative symptom score (14.4) than those with partial penectomy and LND (7.9).Conclusions: PROs provide an insight into the morbidity of therapies for PeCa, and the most symptoms are reported by patients with recurrent disease.

scholarly journals Lessons learned: Linking patient-reported outcomes data with administrative databases

2018 ◽  
Vol 3 (4) ◽  
Author(s):  
Laura Davis ◽  
Alyson Mahar ◽  
Lev Bubis ◽  
Qing Li ◽  
Haoyu Zhao ◽  
...  
Keyword(s):  
Data Collection ◽  
Administrative Data ◽  
Patient Reported Outcomes ◽  
Symptom Assessment ◽  
Lessons Learned ◽  
Assessment System ◽  
System Level ◽  
Administrative Databases ◽  
Composite Indices ◽  
Patient Reported

IntroductionSince 2007, Cancer Care Ontario (CCO) has systematically collected patient-reported outcomes (PROs) in the form of symptom data, for cancer outpatients visiting regional cancer centres or affiliate institutions. Data are used in real-time to facilitate conversation between clinicians and patients and have recently been combined with provincial administrative databases. Objectives and ApproachCCO collects PROs using the Edmonton Symptom Assessment System (ESAS), which scores 9 symptoms on a scale of 0 (no symptoms) to 10 (worst symptom severity). Data were imported from CCO in 2015 and linked to a cancer cohort at ICES. We investigated differences between patients who completed $\geq$1 ESAS record and patients who did not, as well as the number of records, timing of data collection and missingness. We describe our experience linking and using the PRO data to administrative data, including presenting trajectories of symptoms over time and combining scores into composite indices. Results120,745 cancer patients had 729,861 symptom records between 2007 and 2014. Not all patients with a cancer diagnosis had $\geq$1 ESAS record and this varied by patient, disease and system level factors. Because implementation occurred from a clinical perspective, data collection was irregular within and across patients and depended on treatment and other factors; the number of records per patient varied, as well the number of contributing patients in each time period following diagnosis. Attempts were made to create meaningful composite indices by combining all symptom scores as well as combining multiple high scores for each individual symptom. As a result, selecting the best statistical analysis to use these PRO data as an exposure or outcome is still uncertain. Conclusion/ImplicationsPRO data linked to provincial, administrative data holdings represent a new frontier for population-based cancer research, both in their challenging structure as well as their implications for clinical practice and health system. These lessons learned will hopefully support other researchers rigorous use of these data in the future.

scholarly journals Low Concordance of Patient-Reported Outcomes With Clinical and Clinical Trial Documentation

2018 ◽  
pp. 1-12 ◽  
Author(s):  
Charlene M. Fares ◽  
Timothy J. Williamson ◽  
Matthew K. Theisen ◽  
Amy Cummings ◽  
Krikor Bornazyan ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Trial ◽  
Gold Standard ◽  
Patient Reported Outcomes ◽  
Psychological Symptoms ◽  
Vital Signs ◽  
Symptom Assessment ◽  
Physical Symptoms ◽  
Albumin Concentration ◽  
Patient Reported

Purpose Health care research increasingly relies on assessment of data extracted from electronic medical records (EMRs). Clinical trial adverse event (AE) logs and patient-reported outcomes (PROs) are sources of data often available in the context of specific research projects. The aim of this study was to evaluate the extent of data concordance from these sources. Patients and Methods Patients enrolled in clinical trials or receiving standard treatment for lung cancer (n = 62) completed validated questionnaires on physical and psychological symptoms at up to three assessment points. Temporally matched documentation was extracted from EMR notes and, for clinical trial participants (n = 41), AE logs. Evaluated data included symptom assessment, vital signs, medication logs, and laboratory values. Agreement (positive, negative) and Cohen’s κ coefficients were calculated to assess concordance of symptoms among sources, with PROs considered the gold standard. Results Patient-reported weight loss correlated significantly with clinical measurements ( t = 2.90; P = .02), and average number of PROs correlated negatively with albumin concentration, supporting PROs as the gold standard. Comparisons of PROs versus EMR yielded poor concordance across 11 physical symptoms, anxiety, and depressive symptoms (all κ < 0.40). Providers under-reported the presence of each symptom in the EMR compared with PROs. AE logs showed similarly poor concordance with PROs (all κ < 0.40, except shortness of breath). Negative agreement among sources was higher than positive agreement for all symptoms except pain. Conclusion There was poor concordance between EMR notes and AE logs with PROs. Findings suggest that EMR notes and AE logs may not be reliable sources for capturing physical and psychological symptoms experienced by patients with lung cancer, supporting use of PRO assessments in oncology practices.

Creation of On-PROST: The Ontario patient-reported outcomes of symptoms and toxicity applied clinical research unit.

2012 ◽  
Vol 30 (34_suppl) ◽  
pp. 47-47
Author(s):  
Geoffrey Liu ◽  
Doris Howell ◽  
Andrea Perez Cosio ◽  
Monika K. Krzyzanowska ◽  
Madeline Li ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Clinical Care ◽  
Population Level ◽  
Symptom Assessment ◽  
Research Unit ◽  
Assessment System ◽  
Services Research ◽  
Disease Treatment ◽  
Patient Reported ◽  
Specific Symptoms

47 Background: The 14 Ontario Regional Cancer Centers serve a catchment of 13 million people, centrally coordinated by Cancer Care Ontario. Since 2009, computer kiosks collect the Edmonton Symptom Assessment System (ESAS) patient reported outcomes (PROs). At specific centers, additional PROs such as the Distress Assessment and Response Tool (DART) have been integrated. On-PROST was created in 2011 to customize PROs for disease-, treatment- and phase-specific symptoms and toxicities, and to address core multidimensional impacts of cancer. On-PROST aims to improve patient experience and quality of care through routine collection of standardized sets of PROs for combined use in clinical care and research. Methods: On-PROST structure has five research pillars, each dependent on quality PROs: Health Services Research; Biomarker Research; Radiation Oncology; Palliative/Supportive Care; and the PROs-Cancer Core items. National/international partnerships are being established to develop, standardize and implement PROs relevant across the entire cancer continuum. Results: National consensus was generated for the implementation of the Canadian PROMs-Cancer Core. Key domains on physical, emotional and social health were included, and implementation testing has begun. In parallel, specific On-PROST sub-projects have focused on identifying, validating, and standardizing logic-based sets of PROs for disease-, treatment- and phase-specific symptoms and toxicities. On-PROST projects have focused on topics that complement existing research by other groups (PROMIS, PRO-CTCAE). Initial projects have included: (i) assessment of dysphagia and related symptoms in head and neck and esophageal cancer populations; (ii) short/long term sexual function in prostate and testicular cancers; (iii) a lung cancer radiogenetic toxicity study; and (iv) patient reported outcomes related to physical activity and other modifiable behaviors after cancer diagnosis. Conclusions: The multi-pronged structure of On-PROST will systematically collect disease-, treatment-, and phase-specific PROs at a population level.

Prospective Validation of the Swedish Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF: Swedish) In 114 MPN Patients

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 5053-5053
Author(s):  
Peter L. Johansson ◽  
Bjorn Andreasson ◽  
Robyn Scherber ◽  
Amylou Dueck ◽  
Jan Samuelsson ◽  
...  
Keyword(s):  
Research Funding ◽  
Patient Reported Outcomes ◽  
Myeloproliferative Neoplasm ◽  
Office Visit ◽  
Symptom Assessment ◽  
Early Satiety ◽  
Patient Reported ◽  
Eortc Qlq C30 ◽  
And Gender ◽  
Eortc Qlq

Abstract Abstract 5053 Background: The Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) is a concise instrument of patient reported outcomes (PRO) designed to assess the unique spectrum of symptoms present in the majority of patients (Mesa et. al. Cancer 2007). We sought to validate the Swedish Translation of the MPN-SAF which addresses 19 separate symptoms reported by MPN patients. Methods: We utilized the standard practice of PRO translation in which 3 independent translations are created by 3 independent translators fluent in both languages. A fourth translator then discussed the translations with the other translators and a consensus translation was obtained. Patients self completed the MPN-SAF: Swedish at the time of a physician office visit and the Swedish EORTC-QLQ-C30 was co-administered for validation purposes. Results: Patients and Symptomatic Burden: 114 patients were prospectively enrolled (ET (N=53; 47%), PV (N=53; 47%) and MF (N=8; 6%)) a median of 6 years (range:0-42) from their diagnosis. Patients were of a median age (68; range 27–88 years) and gender (53% females) typical of the disease. 78% (N=88) had received some form of non-aspirin medical therapy for their disease, and 75% were on therapy at the time of completing the questionnaire. Patients frequently had a history of either thrombotic events (26%) and/or hemorrhagic events (10%). The MPN-SAF measured 19 items in the enrolled patients (data summarized in Table 1). Validation Analysis: EORTC-QLQ-C30 Consistent with our experience with the MPN-SAF:English Pearson correlations between MPN-SAF-Swedish individual symptom scores and the Swedish EORTC-QLQ C30 showed excellent correlations with co-validation questions including fatigue, pain, headache, insomnia, early satiety, and sad mood (all p<0.001). Correlations with EORTC-QLQ-C30 subscales demonstrated excellent correlations between MPN-SAF measurements and corresponding subscales. Comparison with Mpn-Saf:English: Comparison with 102 patients prospectively completing the MPN-SAF: English (ET=20, PV=N=23, MF=59) showed (when adjusting for MPN subtype) excellent correlation with all but 3 items in which the prevalence of the symptoms was similar but the severity less in the Swedish cohort (early satiety, headache and impaired quality of life). Additionally, the ranking of the prevalence of symptoms was very well correlated between both cohorts when controlling for disease type. Conclusions: The MPN-SAF: Swedish is an easy to administer, clear, 19 item inventory of patient reported outcomes that is specific to MPNs. Additionally, the instrument is validated by 1) comparison to previously validated Swedish Instruments and 2) the correlation with the MPN-SAF:English. Utilization of the instrument in Swedish MPN clinical trials will allow for useful comparison to patients completing the MPN-SAF in other countries. Disclosures: Samuelsson: Roche Sweden: Mesa: SBio: Research Funding; Novartis: Research Funding; Celgene: Research Funding; Incyte: Research Funding; Roche: Research Funding; eisai: Research Funding; telik: Research Funding.

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