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1.
JCO Clin Cancer Inform ; 7: e2300182, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37897263

RESUMO

PURPOSE: There is raising interest to implement electronic patient-reported outcomes (ePROs) for symptom monitoring to enhance the quality of cancer care. Step 1 of the Texas Two-Step Study demonstrated successful implementation of an ePRO system in >200 sites of service of a large community oncology practice. We now report step 2 of this study which evaluates the impact of ePROs on outcomes among patients enrolled in the Centers for Medicare & Medicaid Services' Oncology Care Model (OCM) program. METHODS: This observational study focused on patients with metastatic cancer enrolled in OCM at large community oncology practice located in Texas between July 2020 and December 2020. Patients who completed ≥1 survey via the ePRO tool were included in the study group and were propensity score matched with patients in a control group. Adverse events (AEs; hospitalizations, emergency department visits, deaths) and total cost of care were a priori study outcomes. Mann-Whitney U and chi-square tests compared continuous and categorical variables, respectively, with multivariable logistic regression for adjustment of covariates. RESULTS: Of 831 patients with metastatic cancer, 458 matched patients (229/group) were identified, with 52% male and a mean age of 74 years. Mean total AEs were lower in the study group compared with control (0.98 v 1.41; P = .007), with decreased hospitalizations (20% v 32.5%; P = .002), emergency visits (38.4% v 42.3%; P > .05), and deaths (11.8% v 16.6%; P > .05). Average number of hospitalizations was lower (0.28 v 0.52; P = .003) with reduced mean duration of hospitalizations (1.9 vs 3.2 d; P = .03). The total cost of care was reduced by an average of $1,146 per member per month. CONCLUSION: Symptom monitoring with ePROs improved quality and value of cancer care delivery by reducing hospitalizations, emergency visits, and deaths while lowering cost of care in a large oncology practice.


Assuntos
Medicare , Neoplasias , Humanos , Masculino , Idoso , Estados Unidos , Feminino , Texas/epidemiologia , Hospitalização , Neoplasias/diagnóstico , Neoplasias/terapia , Medidas de Resultados Relatados pelo Paciente , Eletrônica
2.
J Clin Oncol ; 41(29): 4652-4663, 2023 Oct 10.
Artigo em Inglês | MEDLINE | ID: mdl-37625107

RESUMO

PURPOSE: Financial toxicity (FT) affects 20% of cancer survivors and is associated with poor clinical outcomes. No large-scale programs have been implemented to mitigate FT. We evaluated the effect of monthly FT screening as part of a larger patient-reported outcomes (PROs) digital monitoring intervention. METHODS: PRO-TECT (AFT-39) is a cluster-randomized trial of patients undergoing systemic therapy for metastatic cancer. Practices were randomly assigned 1:1 to digital symptom monitoring (PRO practices) or usual care (control practices). Digital monitoring consisted of between-visit online or automated telephone patient surveys about symptoms, functioning, and FT (single-item screening question from Functional Assessment of Chronic Illness Therapy-COmprehensive Score for financial Toxicity) for up to 1 year, with automated alerts sent to practice nurses for concerning survey scores. Clinical team actions in response to alerts were not mandated. The primary outcome of this planned secondary analysis was development or worsening of financial difficulties, assessed via the European Organisation for Research and Treatment of Cancer QLQ-C30 financial difficulties measure, at any time compared with baseline. A randomly selected subset of patients and nurses were interviewed about their experiences with the intervention. RESULTS: One thousand one hundred ninety-one patients were enrolled (593 PRO; 598 control) at 52 US community oncology practices. Overall, 30.2% of patients treated at practices that received the FT screening intervention developed, or experienced worsening of, financial difficulties, compared with 39.0% treated at control practices (P = .004). Patients and nurses interviewed stated that FT screening identified patients for financial counseling who otherwise would be reluctant to seek, or unaware of the availability of, assistance. CONCLUSION: In this report of a secondary outcome from a randomized clinical trial, FT screening as part of routine digital patient monitoring with PROs reduced the development, or worsening, of financial difficulties among patients undergoing systemic cancer therapy.


Assuntos
Estresse Financeiro , Neoplasias , Humanos , Qualidade de Vida , Neoplasias/tratamento farmacológico , Neoplasias/complicações , Medidas de Resultados Relatados pelo Paciente
3.
JCO Clin Cancer Inform ; 7: e2200187, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-36857630

RESUMO

PURPOSE: Symptoms are common in patients receiving systemic treatment for metastatic cancer. Monitoring patients with electronic patient-reported outcomes (ePROs) detects severe and worsening symptoms early, enabling care teams to intervene and prevent downstream complications and thereby improving outcomes. The Centers for Medicare & Medicaid Services will require patient-reported outcome (PRO) monitoring in the upcoming Enhancing Oncology Model, and many practices will likely attempt to implement PROs in patient care for the first time. METHODS: To assist practices with the design and implementation of ePRO remote symptom monitoring programs, tenets were drawn from prior ePRO program experiences and research. RESULTS: Successful implementation requires a quality improvement approach to change management with attention to software functionality, measured outcomes, personnel deployment, leadership and culture, workflow, equity, and patient engagement. Specific approaches in each of these areas can optimize program participation and effectiveness. Continuous program monitoring to identify and address barriers is essential to success. Initial challenges with personnel acceptance and patient participation are common and can be overcome by using these tenets. CONCLUSION: Remote symptom monitoring with ePROs is a key component of quality cancer care and population health management that requires organizational commitment and a deliberate approach by practices using established tenets to assure successful implementation.


Assuntos
Medicare , Neoplasias , Idoso , Estados Unidos , Humanos , Oncologia , Participação do Paciente , Medidas de Resultados Relatados pelo Paciente , Eletrônica
4.
Lancet Oncol ; 24(2): e86-e95, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-36725153

RESUMO

The use of item libraries for patient-reported outcome (PRO) measurement in oncology allows for the customisation of PRO assessment to measure key health-related quality of life concepts of relevance to the target population and intervention. However, no high-level recommendations exist to guide users on the design and implementation of these customised PRO measures (item lists) across different PRO measurement systems. To address this issue, a working group was set up, including international stakeholders (academic, independent, industry, health technology assessment, regulatory, and patient advocacy), with the goal of creating recommendations for the use of item libraries in oncology trials. A scoping review was carried out to identify relevant publications and highlight any gaps. Stakeholders commented on the available guidance for each research question, proposed recommendations on how to address gaps in the literature, and came to an agreement using discussion-based methods. Nine primary research questions were identified that formed the scope and structure of the recommendations on how to select items and implement item lists created from item libraries. These recommendations address methods to drive item selection, plan the structure and analysis of item lists, and facilitate their use in conjunction with other measures. The findings resulted in high-level, instrument-agnostic recommendations on the use of item-library-derived item lists in oncology trials.


Assuntos
Neoplasias , Qualidade de Vida , Humanos , Neoplasias/terapia , Medidas de Resultados Relatados pelo Paciente , Oncologia , Avaliação de Resultados da Assistência ao Paciente
5.
PLOS Digit Health ; 2(1): e0000178, 2023 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-36812616

RESUMO

Clinical performance status is designed to be a measure of overall health, reflecting a patient's physiological reserve and ability to tolerate various forms of therapy. Currently, it is measured by a combination of subjective clinician assessment and patient-reported exercise tolerance in the context of daily living activities. In this study, we assess the feasibility of combining objective data sources and patient-generated health data (PGHD) to improve the accuracy of performance status assessment during routine cancer care. Patients undergoing routine chemotherapy for solid tumors, routine chemotherapy for hematologic malignancies, or hematopoietic stem cell transplant (HCT) at one of four sites in a cancer clinical trials cooperative group were consented to a six-week prospective observational clinical trial (NCT02786628). Baseline data acquisition included cardiopulmonary exercise testing (CPET) and a six-minute walk test (6MWT). Weekly PGHD included patient-reported physical function and symptom burden. Continuous data capture included use of a Fitbit Charge HR (sensor). Baseline CPET and 6MWT could only be obtained in 68% of study patients, suggesting low feasibility during routine cancer treatment. In contrast, 84% of patients had usable fitness tracker data, 93% completed baseline patient-reported surveys, and overall, 73% of patients had overlapping sensor and survey data that could be used for modeling. A linear model with repeated measures was constructed to predict the patient-reported physical function. Sensor-derived daily activity, sensor-derived median heart rate, and patient-reported symptom burden emerged as strong predictors of physical function (marginal R2 0.429-0.433, conditional R2 0.816-0.822). Trial Registration: Clinicaltrials.gov Id NCT02786628.

6.
BMC Health Serv Res ; 22(1): 538, 2022 Apr 22.
Artigo em Inglês | MEDLINE | ID: mdl-35459238

RESUMO

BACKGROUND: Symptoms in patients with advanced cancer are often inadequately captured during encounters with the healthcare team. Emerging evidence demonstrates that weekly electronic home-based patient-reported symptom monitoring with automated alerts to clinicians reduces healthcare utilization, improves health-related quality of life, and lengthens survival. However, oncology practices have lagged in adopting remote symptom monitoring into routine practice, where specific patient populations may have unique barriers. One approach to overcoming barriers is utilizing resources from value-based payment models, such as patient navigators who are ideally positioned to assume a leadership role in remote symptom monitoring implementation. This implementation approach has not been tested in standard of care, and thus optimal implementation strategies are needed for large-scale roll-out. METHODS: This hybrid type 2 study design evaluates the implementation and effectiveness of remote symptom monitoring for all patients and for diverse populations in two Southern academic medical centers from 2021 to 2026. This study will utilize a pragmatic approach, evaluating real-world data collected during routine care for quantitative implementation and patient outcomes. The Consolidated Framework for Implementation Research (CFIR) will be used to conduct a qualitative evaluation at key time points to assess barriers and facilitators, implementation strategies, fidelity to implementation strategies, and perceived utility of these strategies. We will use a mixed-methods approach for data interpretation to finalize a formal implementation blueprint. DISCUSSION: This pragmatic evaluation of real-world implementation of remote symptom monitoring will generate a blueprint for future efforts to scale interventions across health systems with diverse patient populations within value-based healthcare models. TRIAL REGISTRATION: NCT04809740 ; date of registration 3/22/2021.


Assuntos
Neoplasias , Qualidade de Vida , Atenção à Saúde , Humanos , Neoplasias/terapia , Projetos de Pesquisa
7.
Clin Trials ; 19(3): 307-315, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35088616

RESUMO

BACKGROUND: In clinical trials and clinical practice, patient-reported outcomes are almost always assessed using multiple patient-reported outcome measures at the same time. This raises concerns about whether patient responses are affected by the order in which the patient-reported outcome measures are administered. METHODS: This questionnaire-based study of order effects included adult cancer patients from five cancer centers. Patients were randomly assigned to complete questionnaires via paper booklets, interactive voice response system, or tablet web survey. Linear Analogue Self-Assessment, Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events, and Patient-Reported Outcomes Measurement Information System assessment tools were each used to measure general health, physical function, social function, emotional distress/anxiety, emotional distress/depression, fatigue, sleep, and pain. The order in which the three tools, and domains within tools, were presented to patients was randomized. Rates of missing data, scale scores, and Cronbach's alpha coefficients were compared by the order in which they were assessed. Analyses included Cochran-Armitage trend tests and mixed models adjusted for performance score, age, sex, cancer type, and curative intent. RESULTS: A total of 1830 patients provided baseline patient-reported outcome assessments. There were no significant trends in rates of missing values by whether a scale was assessed earlier or later. The largest order effect for scale scores was due to a large mean score at one assessment time point. The largest difference in Cronbach's alpha between the versions for the Patient-Reported Outcomes Measurement Information System scales was 0.106. CONCLUSION: The well-being of a cancer patient has many different aspects such as pain, fatigue, depression, and anxiety. These are assessed using a variety of surveys often collected at the same time. This study shows that the order in which the different aspects are collected from the patient is not important.


Assuntos
Neoplasias , Medidas de Resultados Relatados pelo Paciente , Adulto , Ansiedade , Fadiga , Humanos , Neoplasias/psicologia , Neoplasias/terapia , Dor , Avaliação de Resultados da Assistência ao Paciente
11.
JAMA Health Forum ; 2(5): e210673, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-35977314

RESUMO

Importance: By 2020, nearly all states had adopted oncology parity laws in the US, ensuring that patients in fully insured private health plans pay no more for orally administered anticancer medications (OAMs) than infused therapies. Between 2013 and mid-2017, 11 states implemented parity with out-of-pocket spending caps, which may further reduce patient out-of-pocket spending. Objective: To compare OAM uptake and out-of-pocket and health plan spending on OAMs in states with parity with and without spending caps, as well as to assess out-of-pocket spending for caps that apply predeductible vs postdeductible. Design Setting and Participants: This cohort study analyzed OAM users enrolled in commercial health plans offered by Aetna, Humana, and United Healthcare in the US from 2011 to 2017, aggregated by the Health Care Cost Institute, using difference-in-difference-in-differences (DDD) analysis. Data analysis was conducted between June and August 2020. Exposures: Time (before vs after parity), whether the state parity law included an out-of-pocket spending cap, and whether the plan was fully insured (subject to parity) or self-funded (not subject to parity). Among states with caps, out-of-pocket spending was also compared by whether the cap was applied predeductible and postdeductible vs only postdeductible. Main Outcomes and Measures: Monthly OAM prescription fills per 100 000 enrollees, per-OAM prescription-fill out-of-pocket spending, and annual per-user health plan spending on OAMs. Results: In this study of 23 states (11 with caps and 12 without) and 207 579 OAM prescription fills, caps were associated with a modest increase in OAM use (DDD, 7.40 [95% CI, 3.41-11.39] per 100 000 enrollees). There was no difference in mean out-of-pocket spending comparing fully insured and self-funded enrollees in states with vs without caps (DDD, -$17 [95% CI, -$57 to $24), but caps were associated with lower spending among OAM users in the 95th percentile of out-of-pocket spending by $831 (95% CI, -$871 to -$791) per OAM prescription fill. Caps applied predeductible were associated with greater out-of-pocket savings relative to caps applied only postdeductible. This included per-OAM prescription-fill savings at the 75th, 90th, and 95th percentiles. Postparity, mean annual spending on OAMs among users was $113 589 in states without caps and $102 252 in states with caps, with no differences between groups (DDD, $9799 [95% CI, -$4230 to $23 829). Conclusions and Relevance: In this cohort study, among states adopting oncology parity laws between 2013 and 2017, mean out-of-pocket spending per OAM prescription fill and mean health plan spending among OAM users was similar in states with and without caps. However, enrollees in states with parity plus out-of-pocket caps had greater reductions in out-of-pocket spending among the highest spenders. Caps may offer improved financial protection for the highest spenders without increasing mean health plan spending on OAMs.


Assuntos
Custos de Cuidados de Saúde , Gastos em Saúde , Estudos de Coortes , Humanos , Renda , Prescrições
12.
J Geriatr Oncol ; 12(4): 623-631, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33277226

RESUMO

OBJECTIVE: To understand the relationship between patient experience, as measured by scores on the Consumer Assessment of Healthcare Providers and Systems (CAHPS®) survey, and clinical and financial outcomes among older cancer survivors. MATERIALS AND METHODS: We analyzed the records of all Fee-for-Service (FFS) Medicare beneficiaries 66 years and older who completed one CAHPS survey from 2001 to 2004 or 2007-2013 with one of the five following cancer types: breast, bladder, colorectal, lung, or prostate; and completed a CAHPS survey within 5 years of cancer diagnosis date. We conducted a multivariate analysis, controlling for clinical and demographic variables, to evaluate the association between excellent CAHPS scores and the following clinical and financial outcomes: mortality, emergency department visits, and total healthcare expenditures. RESULTS: A total of 7395 individuals were present in our cohort, with 57% being male and 85.7% non-Hispanic White. Breakdown of the cohort by cancer site is as follows: prostate (40.4%), breast (28.6%), colorectal (14.0%), lung (9.4%), and bladder (7.6%). When looking at the relationship between CAHPS scores and clinical outcomes, there was no significant difference between excellent and non-excellent CAHPS score respondents in all three of the clinical outcomes studied. Furthermore, there was no association between ED utilization and patient experience scores when stratifying by cancer site and race/ethnicity among this cohort. CONCLUSION: In this cohort, a highly rated patient experience, as measured by responses on the CAHPS survey, is not associated with improved clinical outcomes among older cancer survivors.


Assuntos
Sobreviventes de Câncer , Neoplasias , Idoso , Planos de Pagamento por Serviço Prestado , Feminino , Pesquisas sobre Atenção à Saúde , Gastos em Saúde , Humanos , Masculino , Medicare , Neoplasias/terapia , Avaliação de Resultados da Assistência ao Paciente , Satisfação do Paciente , Estados Unidos/epidemiologia
13.
J Urol ; 205(2): 434-440, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-32909877

RESUMO

PURPOSE: Life expectancy has become a core consideration in prostate cancer care. While multiple prediction tools exist to support decision making, their discriminative ability remains modest, which hampers usage and utility. We examined whether combining patient reported and claims based health measures into prediction models improves performance. MATERIALS AND METHODS: Using SEER (Surveillance, Epidemiology, and End Results)-CAHPS (Consumer Assessment of Healthcare Providers and Systems) we identified men 65 years old or older diagnosed with prostate cancer from 2004 to 2013 and extracted 4 types of data, including demographics, cancer information, claims based health measures and patient reported health measures. Next, we compared the performance of 5 nested competing risk regression models for other cause mortality. Additionally, we assessed whether adding new health measures to established prediction models improved discriminative ability. RESULTS: Among 3,240 cases 246 (7.6%) died of prostate cancer while 631 (19.5%) died of other causes. The National Cancer Institute Comorbidity Index score was associated but weakly correlated with patient reported overall health (p <0.001, r=0.21). For predicting other cause mortality the 10-year area under the receiver operating characteristic curve improved from 0.721 (demographics only) to 0.755 with cancer information and to 0.777 and 0.812 when adding claims based and patient reported health measures, respectively. The full model generated the highest value of 0.820. Models based on existing tools also improved in their performance with the incorporation of new data types as predictor variables (p <0.001). CONCLUSIONS: Prediction models for life expectancy that combine patient reported and claims based health measures outperform models that incorporate these measures separately. However, given the modest degree of improvement, the implementation of life expectancy tools should balance model performance with data availability and fidelity.


Assuntos
Expectativa de Vida , Modelos Estatísticos , Neoplasias da Próstata/mortalidade , Idoso , Estudos de Coortes , Humanos , Masculino , Medicare , Autorrelato , Estados Unidos
14.
J Manag Care Spec Pharm ; 27(1): 118-126, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33103618

RESUMO

Despite rising interest in integrating the patient voice in value-based payment (VBP) models for oncology, barriers persist to implementing patient-reported measures (PRMs), including patient-reported performance measures (PR-PMs). This article describes the landscape of oncology PRMs and PR-PMs, identifies implementation barriers, and recommends solutions for public and private payers to accelerate the appropriate use of PRMs in oncology VBP programs. Our research used a multimethod approach that included a literature review, landscape scan, stakeholder interviews and survey, and a multistakeholder roundtable. The literature review and landscape scan found that limited oncology-specific PR-PMs are available and some are already used in VBP programs. Diverse stakeholder perspectives provided insight into filling current gaps in measurement and removing implementation barriers, such as limited relevance of existing PRMs and PR-PMs for oncology; methodological challenges; patient burden and survey fatigue; and provider burden from resource constraints, competing priorities, and insufficient incentives. Key recommendations include: (a) identify or develop meaningful measures that fill gaps, engaging patients throughout measure and program development and evaluation; (b) design programs that include scientifically sound measures standardized to reduce patient and provider burden while supporting care; and (c) engage providers using a stepwise approach that offers resources and incentives to support implementation. DISCLOSURES: Funding for this project was provided by the National Pharmaceutical Council. Schmidt, Perkins, Riposo, and Patel are employees of Discern Health, a consulting firm with many clients, including government, life sciences, nonprofit, and provider organizations. Valuck is a partner at Discern Health. Westrich is an employee of the National Pharmaceutical Council, an industry-funded health policy research group that is not involved in lobbying or advocacy. Basch reports grants from National Cancer Institute and Patient-Centered Outcomes Research Institute; fees from serving as a consultant on research projects at Memorial Sloan Kettering Cancer Center, Dana-Farber Cancer Institute, and Research Triangle Institute/CMS; and fees from serving as a scientific advisor to CareVive Systems, Sivan Healthcare, Navigating Cancer, and AstraZeneca, outside the submitted work. McClellan reports fees from serving on the boards of Johnson & Johnson and Seer Bio and as an advisor to Cota outside the submitted work; and McClellan is an independent board member on the boards of Cigna and Alignment Healthcare, co-chair of the Guiding Committee for the Health Care Payment Learning and Action Network, and receives fees for serving as an advisor for MITRE, outside the submitted work.


Assuntos
Antineoplásicos/efeitos adversos , Planos de Pagamento por Serviço Prestado , Oncologia/normas , Medidas de Resultados Relatados pelo Paciente , Antineoplásicos/economia , Humanos , Estados Unidos
17.
J Natl Cancer Inst ; 112(10): 1055-1062, 2020 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-31883008

RESUMO

BACKGROUND: In this study, we sought to estimate the association between oral oncology parity law adoption and anticancer medication use for patients with chronic myeloid leukemia or multiple myeloma. METHODS: This was an observational study of administrative claims from 2008 to 2017. Among individuals initiating tyrosine kinase inhibitors (TKIs) for chronic myeloid leukemia or immunomodulatory drugs for multiple myeloma, we compared out-of-pocket spending, adherence, and discontinuation before and after parity among individuals in fully insured plans (subject to parity) vs self-funded plans (exempt from parity) using propensity-score weighted difference-in-differences regression models. RESULTS: Among patients initiating TKIs (N = 2082) or immunomodulatory drugs (N = 3326) there were no statistically significant differences in adherence or discontinuation associated with parity. The proportion of patients with initial out-of-pocket payments of $0 increased in fully insured plans after parity from 5.7% to 46.1% for TKIs and from 10.9% to 48.8% for immunomodulatory drugs. Relative to changes in self-funded plans, those in fully insured plans were 4.27 (95% CI = 2.20 to 8.27) times as likely to pay nothing for TKIs and 1.96 (95% CI = 1.40 to 2.73) times as likely to pay nothing for immunomodulatory drugs after parity. Similarly, the proportion paying more than $100 decreased from 30.3% to 24.7% for TKIs and 30.6% to 27.5% for immunomodulatory drugs in fully insured plans after parity. Relative to changes in self-funded plans, those in fully insured plans were 0.74 (95% CI = 0.54 to 1.01) times as likely to pay more than $100 for TKIs and 0.85 (95% CI = 0.68 to 1.06) times as likely to pay more than $100 for immunomodulatory drugs after parity. CONCLUSIONS: Among patients initiating TKIs or immunomodulatory drugs, parity was not associated with better adherence or less discontinuation of therapy but yielded decreased patient out-of-pocket payments for some patients.


Assuntos
Gastos em Saúde/estatística & dados numéricos , Leucemia Mielogênica Crônica BCR-ABL Positiva/tratamento farmacológico , Leucemia Mielogênica Crônica BCR-ABL Positiva/economia , Mieloma Múltiplo/tratamento farmacológico , Mieloma Múltiplo/economia , Administração Oral , Adulto , Feminino , Humanos , Fatores Imunológicos/administração & dosagem , Fatores Imunológicos/economia , Cobertura do Seguro/estatística & dados numéricos , Masculino , Adesão à Medicação/estatística & dados numéricos , Pessoa de Meia-Idade , Patient Protection and Affordable Care Act , Inibidores de Proteínas Quinases/administração & dosagem , Inibidores de Proteínas Quinases/economia , Estados Unidos
18.
JAMA Oncol ; 6(2): e193332, 2020 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-31556911

RESUMO

Importance: Standard adverse event (AE) reporting in oncology clinical trials has historically relied on clinician grading, which prior research has shown can lead to underestimation of rates of symptomatic AEs. Industry sponsors are beginning to implement in trials the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), which was developed to allow patients to self-report symptomatic AEs and improve the quality of symptomatic AE detection. Objectives: To evaluate the feasibility of implementing PRO-CTCAE in a prespecified correlative analysis of the phase 3 COMET-2 trial and enumerate statistically significant between-group differences in symptomatic AEs using PRO-CTCAE and the CTCAE. Design, Setting, and Participants: This correlative study of 119 men in the randomized, double-blind, placebo-controlled phase 3 COMET-2 trial with metastatic castration-resistant prostate cancer who had undergone at least 2 prior lines of systemic treatment was conducted from March 2012 to July 2014. Participants completed PRO-CTCAE items using an automated telephone system from home prior to treatment and every 3 weeks during treatment. Statistical analysis was performed from May 2018 to June 2019. Main Outcomes and Measures: The proportion of patients who completed expected PRO-CTCAE self-reports was computed as a measure of feasibility. Results: Among the 119 men in the study (median age, 65 years [range, 44-80 years]), 534 of 587 (91.0%) expected PRO-CTCAE self-reports were completed, with consistently high rates of completion throughout participation. Rates of self-report adherence were similar between groups (cabozantinib s-maleate, 286 of 317 [90.2%]; and mitoxantrone hydrochloride-prednisone, 248 of 270 [91.9%]). Of 12 measured, patient-reported PRO-CTCAE symptomatic AEs, 4 reached statistical significance when comparing the proportion of patients with at least 1 postbaseline score greater than 0 between groups (differences ranged from 20.1% to 34.1% with higher proportions in the cabozantinib group; all P < .05), and use of a method for accounting for preexisting symptoms at baseline yielded 7 AEs with statistically significant differences between groups (differences ranged from 20.5% to 41.2% with higher proportions in the cabozantinib group; all P < .05). In the same analysis using investigator-reported CTCAE data, no statistically significant differences were found between groups for any symptomatic AEs. Conclusions and Relevance: PRO-CTCAE data collection was feasible and improved the accuracy of symptomatic AE detection in a phase 3 cancer trial. This analysis adds to mounting evidence of the feasibility and value of patient-reported AEs in oncology, which should be considered for inclusion in cancer trials that incorporate AE evaluation. Trial Registration: ClinicalTrials.gov identifier: NCT01522443.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Medidas de Resultados Relatados pelo Paciente , Neoplasias de Próstata Resistentes à Castração/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Método Duplo-Cego , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias de Próstata Resistentes à Castração/patologia
20.
Support Care Cancer ; 27(12): 4525-4534, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30915567

RESUMO

BACKGROUND: Patients initiating highly emetic chemotherapy (HEC) are at a 90% risk of chemotherapy-induced nausea and vomiting (CINV). Despite guideline-concordant antiemetic prescribing preventing CINV in up to 80% of patients, studies suggest that guideline-concordant antiemetic regimen use by patients initiating HEC is sub-optimal. However, these studies have been limited to single-site or single-cancer type with limited generalizability. The objective of this study was to describe antiemetic fill regimens and to assess predictors of underuse in the USA. METHODS: Our study population was adult patients under the age of 65 with cancer initiating intravenous HEC between 2013 and 2015 with employer-sponsored insurance in the IBM Watson/Truven MarketScan Commercial Claims database (N = 31,923). Descriptive statistics were used to explain antiemetic prescribing patterns, including antiemetic underuse. Modified Poisson regression was used to identify factors associated with antiemetic underuse. RESULTS: Among individuals initiating HEC, 49% underused guideline-concordant antiemetics. Most classified as under-using lacked an NK1 fill. While dexamethasone and 5HT3A uptake was over 80%, olanzapine use was minimal. Having lower generosity for prescription and medical benefits (paying more versus less than 20% out-of-pocket) increased the underuse risk by 3% and 4% (RR,1.03; 95% CI,1.01-1.05; P = 0.01 and RR,1.04; CI, 1.00-1.09; P = 0.03), respectively. Additionally, compared to receiving chemotherapy in the physician office setting, patients were at a 28% (RR, 1.28; 95% CI, 1.25-1.30; P < 0.0001) higher underuse risk in the outpatient hospital setting. CONCLUSION: Antiemetic underuse is high in patients initiating HEC, potentially leading to avoidable CINV events. We found that insurance generosity has a minimal effect on antiemetic guideline concordance in this population, suggesting discordance may be the result of site of care as well as gaps in provider knowledge or accountability.


Assuntos
Antieméticos/administração & dosagem , Antineoplásicos/efeitos adversos , Náusea/prevenção & controle , Neoplasias/tratamento farmacológico , Vômito/prevenção & controle , Adolescente , Adulto , Antineoplásicos/administração & dosagem , Bases de Dados Factuais , Feminino , Fidelidade a Diretrizes , Humanos , Seguro Saúde , Masculino , Pessoa de Meia-Idade , Náusea/induzido quimicamente , Vômito/induzido quimicamente , Adulto Jovem
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