bluuebunny/crossref_metadata_2025 huggingface dataset:
Increase in side effect bother was associated with early treatment discontinuation in a clinical trial among multiple myeloma patients.
Authors: Peipert John , Zhao Fengmin , Lee Ju-Whei , Hong Fangxin , Ip Edward , Gareen Ilana F , O'Connell Nathaniel , Carlos Ruth , Stewart A. Keith , Weiss Matthias , Sparano Joseph A. , Cella David , Gray Robert James , Wagner Lynne I.
Published: May 2020

e19136

Background: Patient reported side effect bother is needed to understand tolerability of cancer drugs. We examined whether increase in side effect bother from baseline to cycle 7 as measured by a single item (GP5) from the FACT-G, “I am bothered by side effects of treatment”, was associated with early treatment discontinuation (ETD) in a multiple myeloma (MM) trial. Methods: Data were drawn from the induction phase of ECOG ACRIN E1A06, a two arm, phase 3 trial conducted in patients with untreated MM. The induction phase occurred over twelve, 28-day cycles. GP5 was assessed at registration and cycle 7. ETD was defined as completion of less than 12 cycles of treatment. We tested whether increase in side effect bother on the GP5 from baseline to cycle 7 was associated with months to ETD in two ways. At each timepoint, GP5 was rated with these response options: “Not at all”, “A little bit”, “Somewhat”, “Quite a bit”, “Very Much”. First, we stratified Kaplan Meier curves by patients with versus without substantially increased side effect burden from registration to cycle 7 on the GP5, defined as an increase of > 2 response categories; Cox regression was used to calculate a hazard ratio. Second, we fit a joint model of the GP5 change trajectory on months to ETD that substituted the estimated slope of a longitudinal logistic regression model into the hazard function of a Cox model. In this model, GP5 was dichotomized as 0 = “Not at all/”A little bit”; 1 = “Somewhat”/ “Quite a bit”/ “Very Much”. Results: 159 patients were followed during induction for a median of 11 months (range: 0.2-16.0). 10 patients (6%) reported a substantial increase on GP5 from registration to cycle 7. After 16 months, these patients had a significantly higher hazard of ETD as estimated by Kaplan Meier methods: 40% experienced ETD vs. 24% of patients without substantial GP5 increase [hazard ratio (HR): 3.08 (95% CI: 1.18-8.02)]. In the joint model, the effect of GP5 on hazard of ETD was larger [HR: 9.56 (95% CI: 2.41-37.82)]. Conclusions: This study found initial evidence that increase in side effect bother as measured by the GP5 predicts ETD and may therefore reflect treatment intolerability in cancer drug trials. The effects found in this study will be tested for replication in additional ECOG-ACRIN trials with diverse designs, treatments, and cancer types. Clinical trial information: NCT00602641 .
Healthcare resource use (HRU) in men with metastatic castration sensitive prostate cancer (mCSPC) receiving androgen deprivation therapy (ADT) only or no treatment in the United States (US).
Authors: Ke Xuehua , Lafeuille Marie-Hélène , Romdhani Hela , Kinkead Frederic , Francis Peter St. John , D'Andrea Denise , Ryan Charles J. , Freedland Stephen J.
Published: May 2020

e19138

Background: mCSPC is clinically complex. Although consensus on treatments are evolving, ADT remains the backbone of therapy. This study assessed the proportion of mCSPC patients treated with ADT only or remaining untreated and their HRU during the mCSPC period in the US. Methods: The Optum Clinformatics Extended DataMart was used to identify men with ≥2 claims for prostate cancer (PC), ≥1 claim for metastasis, ≥1 castration sensitivity (CS) indicator (CS diagnosis code [dx]; castration and no prostate-specific antigen [PSA] rise; or hormone/castration naive for ≥18 months [mo] before index [date of 1st metastasis dx on or after 1st PC dx and between 2015-2018]). Patients were excluded if they had a pre-index castration-resistance (CR) indicator (CR dx; castration within ≥90 days pre-index or with PSA rise; or a claim for a drug solely recommended for metastatic CRPC). mCSPC period (F/U) was defined as time from index until CR (i.e., any post-index CR indicator or initiation of abiraterone acetate or docetaxel ≥12 mo after post-index ADT initiation or ≥12 mo post-index for those with no ADT) or end of data. The proportion of patients receiving ADT only or no mCSPC treatment during F/U was reported. Per-patient-per-year (PPPY) all-cause HRU were evaluated during baseline (12 mo pre-index) and F/U. Descriptive statistics were used: n (%) for binary and mean [SD] for continuous variables. Results: A total of 2,825 mCSPC patients were identified (age: 75 [9] years). Of these, 2,181 (77%) received ADT only or no treatment in a F/U of 10.9 [9.0] mo. Among them, there were more patients with ≥1 inpatient (IP) stay or ≥1 emergency room (ER) visit (F/U vs. baseline; IP: 50% vs. 20%; ER: 57% vs. 44%), and patients had more IP stays and ER visits (IP: 2.0 [4.0] vs. 0.3 [0.7] stays; ER: 3.2 [7.1] vs. 1.1 [2.2] visits) and more IP days (27 [61] vs. 3 [11] days) PPPY in F/U vs. baseline. Trends were similar among patients receiving ADT only (N=1,252 [44%]; F/U of 12.6 [9.0] mo; Table). Conclusions: The majority of mCSPC patients were treated with ADT only or remained untreated and incurred substantial HRU. These findings suggest that improvements in therapy and prompt treatment initiation in men with mCSPC are needed to improve outcomes. [Table: see text]
Relative dose intensity and pathologic response rates in HIV-infected and HIV-uninfected breast cancer patients who received neoadjuvant chemotherapy.
Authors: Martei Yehoda M. , Grover Surbhi , Narasimhamurthy Mohan , Setlhako Dipho Irene I , Ayane Gezahen N , Ralefala Tlotlo Bathethi , Chiyapo Sebathu Phillip , Gross Robert , DeMichele Angela , Shulman Lawrence N.
Published: May 2020

e19140

Background: HIV-infected (HIV+) breast cancer patients may have significantly worse survival compared to HIV-uninfected (HIV-). If so, identifying the underlying mechanism might lead to effective interventions to reduce the disparity. Relative dose intensity (RDI) < 0.85 has been associated with worse survival outcomes in non-metastatic breast cancer patients. We aimed to determine if RDI of chemotherapy and pathologic complete response (pCR) rates were lower for HIV+ patients who received neoadjuvant chemotherapy (NAC) compared with HIV-. Methods: We conducted a prospective cohort study in newly diagnosed breast cancer patients with locally advanced disease who initiated NAC at Princess Marina Hospital in Botswana between 2/2017 and 9/2019. Clinical and treatment data were collected at baseline and at every treatment visit. Surgical pathology post-NAC was graded as pCR if there was no invasive disease in the breast or lymph nodes. RDI was calculated for each patient, with optimal RDI ≥ 0.85. Dichotomous variables were compared using Fisher’s exact and chi-squared tests; and continuous variables using rank sum tests. Results: 111 patients were enrolled, of whom 84 (75.7%) were HIV-, 26 (23.4%) HIV+ and 1 (0.9%) with unknown status who was excluded from final analysis. HIV+ patients were less likely to receive optimal RDI (0.74 vs. 0.88; p = 0.03). Of the 110 patients 15 (13.6%) were still receiving chemotherapy; 22 (20%) prematurely discontinued chemotherapy of whom 11 (10%) received surgery; 7 (6.4%) completed chemotherapy but had no surgery. 77 (70%) completed surgery which included 11 (10%) with no pathology reports available, 3 (2.7%) inadequate surgical specimens and 63 (57.3%) complete pathology results included in pCR analysis: 1/13 (7.7%) HIV+ patients had a pCR compared to 12/50 (24%) in HIV-(p = 0.27). Conclusions: HIV+ patients were significantly more likely to receive inadequate neoadjuvant chemotherapy dose intensity, and trended towards a lower pCR in this small cohort, which may contribute to adverse treatment outcomes. Further study needed to validate high rate of treatment discontinuation and specific risk factors to inform targeted interventions to improve therapy delivery.
End-of-life health care utilization (EOLHCU) in patients with thoracic, head and neck cancers with or without phase I study participation at a single institution.
Authors: Min-Tran Dominic , Gustafson Annika , Eaton Keith D. , Loggers Elizabeth Trice , Rodriguez Cristina P. , Santana-Davila Rafael
Published: May 2020

e19153

Background: Several retrospective studies suggest patients enrolled in clinical trials have more end-of-life health care utilization (EOLHCU). This is particularly concerning for phase I clinical trial participants who are known to have therapeutic misconceptions about the purpose and benefits of phase I clinical trial participation. Methods: We identified all phase I participants at the Seattle Cancer Care Alliance (SCCA) with thoracic, head and neck cancers (THNC) who died between July 1, 2014 and June 30, 2018(P1C). We compared them to 139 randomly selected THNC patients who died within the same time period without phase I study participation (NP1C). Patient records were abstracted from the electronic health record (and Epic Care Everywhere if patients received EOL care outside of SCCA). A chi-square test was used to compare categorial variables and t-tests were used for numerical variables. Results: 67 P1C patients were identified; 3 patients had no outside records at the end of life and were removed from the database. No statistically significant differences in gender, ethnicity, marital status, or form of insurance were found between the two groups. P1C patients were younger (median age of 62 (interquartile range (IQR) 55-69) vs. 66 (IQR 59-72), p=0.008) and had more lines of therapy from diagnosis until death (median 4 (IQR 1-3) vs. 2 (IQR 1-3), p=<0.0001). No difference in end-of-life care or quality of death metrics were found between the two groups, however a trend toward more referrals to palliative care were noted in phase I participants. (Table). Conclusions: At our center no differences in EOLHCU or quality of death parameters were seen in THNC patients who did or did not participate in phase I studies. [Table: see text]
Enhancing the effectiveness of chemotherapy prescribing: A validation study of ChemoPalRx.
Authors: Tareen Serene , Ziyeh Sharvina , Powell Leland Duer , Hung Kin Wai (Tony)
Published: May 2020

e19161

Background: ChemoPalRx is a free iOS mobile application developed for chemotherapy referencing and prescribing. Providers can readily download and use ChemoPalRx to generate and print chemotherapy formatted prescriptions. In the absence of a computerized chemotherapy order entry system, institutions may adopt ChemoPalRx for chemotherapy prescribing in place of traditional methods such as handwritten prescriptions. However, effectiveness of ChemoPalRx in the real-world practices has not been established. Methods: With our aim to determine the effectiveness of ChemoPalRx, we conducted a cross sectional study at an academic institution. Our study primary predictor was the method of generating a chemotherapy order, dichotomized as “handwritten” or “ChemoPalRx”. Primary outcome was corrected order, dichotomized as “corrected” or “satisfactory” order. Corrections were defined as any correction made to an order (e.g. illegible handwriting, modifications in drug dosing, missing chemotherapy or patient’s information). Covariates included fellowship training year (first, second, or third) and complexity of order (“simple” = 2 drugs or less; “complex” = 3 drugs or more). Correction rate (CR) was defined as the proportion of corrected orders. Chi Square test was used for statistical analysis. Results: From October 2019 to December 2019, 288 chemotherapy orders were examined, of which, 226 were handwritten (78.5%) and 62 were ChemoPalRx (21.5%). Of the 226 handwritten orders, 184 (81%) were satisfactory, 42 (19%) were corrected. Of the 62 ChemoPalRx orders, 57 (92%) were satisfactory, 5 (8%) were corrected. CR was significantly reduced by ChemoPalRx compared to handwritten (p = 0.034). Subgroup analysis found that first-year fellows tend to make more corrections on complex orders (CR: 19%) compared to second- and third-year fellows (CR: 6%) (p = 0.19), while second- and third- year fellows made more corrections on simple orders (CR: 22%) compared to first-year fellows (CR: 9%) (p = 0.013). Conclusions: ChemoPalRx significantly enhanced prescription accuracy compared to handwritten chemotherapy orders. Implementation of ChemoPalRx in real-world practices is validly feasible and effective. While ChemoPalRx may support less experienced providers on more complex orders, it may help to catch overlooked simple details for the experienced providers. In the evolving digital era in oncology, ChemoPalRx may be a promising alternative to handwritten prescriptions that can be readily available at one’s fingertips.
Design and implementation of a core tool for quality evaluation of cancer care in 10 oncology institutions in Colombia.
Authors: Pino Luis Eduardo , Triana Ivan Camilo , Potes Diana , Cortes Henry JULIAN , Alcantara Alejandra , Cuervo Angela , Vargas Paola
Published: May 2020

e19166

Background: Measuring quality in cancer care is a complex process due to the heterogeneity of the medical information and the biological complexity of the disease. There are different tools designed for this purpose, including the ASCO QOPI scale that includes core and specific dimensions for some types of cancer. In Colombia there is no specific quality tools in cancer for the evaluation of providers. Methods: This is an observational study. We designed and applied an oncology quality evaluation tool based in the SCO QOPI scale, but adapted to regional language and available technologies. This tool was based on six dimensions, each one weighted according to its relevance in the quality of cancer care (percentage in parentheses): Patient identification (5), oncologic history (25), physical exam (5), diagnostic tests (20), treatment plan (40) and readability (5).The tool was applied to four diseases: Breast cancer, colon cancer, non-small cell lung cancer (NSCLC) and multiple myeloma. 706 clinical cases were evaluated from 10 hospitals, both general and oncological. After evaluating each case, 171 met with the criteria, however, only 110 had complete clinical records. Four auditor physicians were trained by a clinical expert for each disease. Results: The distribution of cases by disease was: Breast cancer 51%, colon cancer 17%, multiple myeloma 22% and NSCLC 10%. Overall result of quality was 51% (maximum score: 100%) which was considered deficient according to the parameters of the tool. The best performance was obtained for cancer hospitals in Medellín (61%) and for a general hospital in Bogotá (56%). The best disease results were obtained in NSCLC (62,4%) and the worst in breast cancer (47%). These results, according to the dimension evaluated were: 33,6% Patient identification, 44,3% oncologic history, 58,2% physical exam, 71,7% diagnostic tests, 33,8% treatment plan and 98,2% readability. Conclusions: Although Medellin and Bogota had the highest comparative performance in this study, the overall results were low. Oncologic history and treatment plan showed deficiencies in their performance, which should be highlighted due to important items such as evaluation of functional scales (ECOG) and intentionality of interventions were considered within adequate decision making. This quality tool is a contribution to the specific evaluation of quality in oncology for countries like Colombia.
Temporal trends in receipt of adjuvant chemotherapy for veterans with colorectal cancer.
Authors: Martin Richard Lewis , Edwards Gretchen C. , Samuels Lauren R. , Eng Cathy , Roumie Christianne L.
Published: May 2020

e19171

Background: For patients with National Comprehensive Cancer Network (NCCN) high risk stage II or stage III colorectal cancer (CRC), adjuvant chemotherapy improves disease free (DFS) and overall survival (OS). Rates of use vary significantly across health care settings. Several demographic and healthcare factors are associated with decreased receipt of chemotherapy; however, few studies have assessed utilization patterns over time. We evaluated receipt of chemotherapy from 2000-2015 among patients treated at a Southeast Regional Veterans Health Administration (VHA) facility to determine local targets for quality improvement initiatives. Methods: We reviewed 1,107 electronic medical records of patients undergoing colorectal surgery from January 1, 2000 to December 31, 2015 at VHA Tennessee Valley Healthcare System. We included patients with NCCN eligible pathologic high risk stage II (T4/perf, R1, < 12LN, LVI) or stage III CRC and excluded for age ≥80, age ≥75 hospitalized in the prior year with a major co-morbidity, and death or hospice within 30 days of surgery. The primary predictor was year of surgery, partitioned 2000-2005 (N = 60), 2006-2010 (N = 64), 2011-2015 (N = 56) to reflect changes in NCCN guidelines. The primary outcome was receipt of any chemotherapy. Results: Of 1,107 colorectal surgeries, we excluded 623 for non-cancers, 212 for stage I or low-risk stage II cancer, 47 for metastatic disease, and 45 for age, co-morbidity, death, and hospice, yielding a final cohort of 121 colon and 59 rectal cancers. Most patients were male (96%), white (79%), with median age 64 years [Interquartile Range 60, 70]. Overall, 117 of 180 (65%) received chemotherapy with a median time to treatment of 50.5 days [40,64]. Adjusting for known correlates, receipt of chemotherapy decreased over time; 2000-2005 (72%), 2006-2010 (69%), 2011-2015 (53%) p = 0.02. Regardless of CRC stage, more patients declined chemotherapy in 2011-2015 (27%) compared to 2000-2005 (6%) and 2006-2010 (8%) p < 0.01. Conclusions: We identified decreased utilization of adjuvant chemotherapy in a non-elderly veteran cohort, which appeared to be due to patients declining chemotherapy regardless of cancer stage. Understanding patient and provider decisions around adjuvant chemotherapy and evaluating trends outside the VHA may offer important insights to implementing quality improvement measures.
Real-world data and patient perspectives on quality care and maintenance therapy (MT) decision-making for recurrent ovarian cancer (ROC).
Authors: Coleman Robert L. , Crawford Rebecca R , Carter Jeffrey D. , Sapir Tamar
Published: May 2020

e19174

Background: Despite clinical evidence illustrating the efficacy of MT for ROC, complexities, such as patient-, treatment-, and disease-related factors, and team-based care coordination, limit its optimal use in ROC. In a quality improvement (QI) program, conducted at 2 oncology systems, we evaluated gaps in evidence-based, quality ROC care. Methods: Between 09/2019-02/2020, retrospective EMR audits of 200 patients with ovarian cancer were analyzed for demographics, disease characteristics, treatment history, and shared decision-making (SDM) involving MT. Surveys were administered to evaluate challenges, barriers and experiences of healthcare professionals (HCP; N = 35) and their patients with ROC (N = 21). The HCP teams participated in audit-feedback sessions and developed action plans for resolving identified gaps. Results: EMR audits revealed low utility of MT among patients with ROC (Table), and only 20% of patients reported that MT was discussed as a treatment option. Lack of access to newer therapies was most commonly identified (27%) by HCP as the biggest challenge in treating patients with ROC. Furthermore, survey results revealed that HCP are challenged to correctly integrate guidelines for patient selection for PARP inhibitor MT based on BRCA mutation status (18% of HCP answered correctly), response to previous chemotherapy (49% correct), and line of therapy (46% correct). Data indicated a low level of SDM – none of the patients indicated a high level involvement in treatment decisions and only 20% indicated a high level of agreement that their care team understood their treatment goals. EMR audits also illustrate low documentation of multiple aspects of SDM (Table). Oncology team members formulated plans to develop guidance documents to assist in therapy sequencing and tools to improve patient education. Conclusions: Overall, data from this QI program indicate gaps, challenges, and barriers in evidence-based, MT decision-making and engagement of patients in SDM. These areas for improvement may be relevant for future interventions to improve the provision of quality ROC care. [Table: see text]
Expert consensus on the development of quality care measures for kidney cancer in Spain.
Authors: Guillem Vicente , Camps Carlos , Climent Duran Miguel Angel , Gonzalez del Alba Aránzazu , Lázaro Quintela Martín Emilio , Mendez Vidal María José , Pinto Alvaro , Puente Javier , Caballero Fernando , Campos Francisco J , Duran Ignacio , Gallardo Diaz Enrique
Published: May 2020

e19180

Background: To promote the continuous improvement of kidney cancer healthcare by proposing quality care measures (with respective indicators and standards) for its diagnosis, treatment and follow-up care that can be used by the corresponding professionals and that can be applied across the Spanish healthcare system. Methods: 1. a) Bibliographic review of international research (previous 5 years) on the quality of kidney cancer care; b) Multidisciplinary nominal group (9 oncology experts from the ECO Foundation –Excellence and Quality in Oncology Foundation – and 2 university methodologists – Francisco de Vitoria University Faculty of Medicine) to identify and select possible quality measures that can be applied in Spain; c) Modified Delphi Consensus (two rounds, remotely) by a panel of 55 oncologists subspecialized in kidney cancer, selected by a geographically stratified snowball sample. The ASCO (American Society of Clinical Oncology) /QOPI (Quality Oncology Practice Initiative) model is followed for the drafting of each item: definition of measures, indicators, information sources, exclusions, clarifications, categorization, acceptable standards. Results: The nominal group proposed 43 possible quality measures to the Delphi panel. Consensus participation rate = 84.5% (47 specialists). A unanimous consensus was achieved for 40 quality measures, grouped into the following areas: 4 structural, 33 regarding treatment process and 3 regarding clinical results. Conclusions: The level of consensus among Spanish oncologists subspecialized in kidney cancer on the proposed care measure for the management of said cancer is very high (93%). These results indicate widespread acceptance and applicability of said measures in the Spanish National Healthcare System and, with this in mind, they will henceforth be a valuable tool for the comparative evaluation of the quality and fairness of the oncological care of kidney cancer patients in Spain.
Review of annual compliance of low-dose CT for lung cancer screening among internal medicine resident physicians in a university teaching program.
Authors: Lopetegui-Lia Nerea , Drekolias Dimitrios , Jafri Syed Imran Mustafa , Vredenburgh James
Published: May 2020

e19187

Background: Lung cancer remains the leading cause of morbidity and mortality, with an estimated 2.1 million newly diagnosed cases each year. A large percentage of cases are detected at an advanced stage, making treatment recalcitrant. Only about 15% are diagnosed at an early stage, highlighting the significance of timely screening. USPSTF recommends annual screening with low-dose computed tomography (LDCT) in adults aged 55-80, who have a 30 pack-year smoking history and are current smokers, or former smokers who have quit within the last 15 years. The National Comprehensive Cancer Network (NCCN) guidelines, as well as the National Lung Screening Trial (NLST), recommend annual screening with LDCT until a person is no longer a candidate for definitive treatment. This study aimed to evaluate the compliance with annual LDCT based on USPSTF guidelines among internal medicine residents from the University of Connecticut residency program at a Clinic in Hartford, Connecticut, USA. Methods: Patients who were under the care of internal medicine residents and who had undergone an initial LDCT for lung cancer screening were included. A total of 61 medical charts were reviewed. Three patients were diagnosed with lung cancer and nineteen patients had their initial LDCT in 2019, and therefore excluded. Results: Out of the 39 patients, 10 patients (25.64%) had a follow-up annual LDCT performed, 2 patients before the annual mark due to various clinical concerns, and 9 patients (23%) in the following 24-48 months. 6 patients (15.38%) had a repeat LDCT ordered but was not done or it was canceled. 12 patients (30.77%) had no repeat LDCT ordered at 12 months. Overall, 69.23% had no follow-up CT at 12 months, and 46.15% with no follow up CT at all at the time of chart review. Conclusions: Based on our analysis, follow-up annual LDCT scans for lung cancer screening on patients under the care of residents-in-training are not being ordered frequently enough. The failure to order annual LDCT could be due to a false sense of relief with a normal initial LDCT, the lack of provider’s awareness of USPSTF guidelines, or insurance issues. Educating primary care providers on the importance of follow-up annual LDCT will ensure early detection and decrease mortality from lung cancer in high risk patient population.
Measuring team effectiveness in healthcare: A comprehensive and practical tool.
Authors: Zajac Stephanie , Griggs Andrew , Cavanaugh Katelyn , Lazzara Elizabeth Hunter , Holladay Courtney
Published: May 2020

e19188

Background: Publication trends reveal that research on teams and teamwork in healthcare has surged over the past decade. Efforts to improve team effectiveness have also become pervasive, with team training being identified as a top strategy for improving patient outcomes. Unfortunately, measures of team effectiveness in the literature vary greatly and are aimed largely toward clinical teams. The aim of this effort, therefore, is twofold: (1) to provide a tool that can be adapted and used to diagnose performance and guide targeted team training across team types, and (2) to further our understanding of teams across all areas of a healthcare system (clinical, research, and administrative) by providing a standard measurement tool. Methods: We began with a comprehensive framework of team effectiveness developed through a top down (i.e., literature review) and bottom-up (i.e., focus groups, interviews) approach. The framework includes 23 constructs identified as critical to teams (e.g., clear roles, supportive culture, conflict management, shared mental models). Next, three subject matter experts (SMEs) identified and compiled measures of team effectiveness published in the healthcare teams literature. Items were reworded as needed to be generally applicable across healthcare team types. The three SMEs then matched each revised item to the framework by independently labeling each with the framework construct it best represents. Items on which 2 out of 3 experts agreed were kept, and new items were generated as needed for construct coverage resulting in a refined item bank. This item bank was again independently rated on quality of item (e.g., clarity, avoidance of double-barreled questions) and construct representativeness (i.e., ensuring the most important aspects of each construct were captured). Two additional subject matter experts then reviewed the ratings, and kept the top five rated items for each construct, ensuring full coverage of the construct (i.e., removing items that were duplicative and tapped the same part of a construct). Results: The processes above resulted in a measure with 115 items that capture 23 fundamental constructs for teams in healthcare. Conclusions: The measure developed is applicable across team types. It can be adapted and used to diagnose team performance, inform training, and further understanding of what facilitates effective teamwork in multi-team systems performing diverse functions across the healthcare system.
Developing a performance matrix for multidisciplinary teams.
Authors: Evans Lynleigh , Liu Yiren , Kwan Terence , Callister James , Byth Karen , Poon Simon , Harnett Paul R.
Published: May 2020

e19200

Background: While multidisciplinary teams (MDTs) are considered the “gold standard” of care for cancer patients, their performance varies widely. This study aimed to develop a user friendly, reliable and valid self-assessment tool for MDTs to evaluate their performance and monitor improvement over time. Methods: Using maturity modelling methodology, key themes from the literature were developed into a 2-dimensional matrix comprising 17 indicators (within 6 components) across 5 levels of performance. A modified Delphi methodology (where 38 MDT members each assigned the contents to components and performance levels using card sorting software) was used to establish face and content validity. A 10 minute on-line version of the matrix was piloted across 11 MDTs. Each participant estimated where they thought the MDT performed for each indicator. Correlation and factor analyses examining convergent and discriminant validity were conducted using SPSS. Cronbach alpha was used to measure internal consistency and evaluate reliability. Ease of use and usefulness were also examined. Results: A total of 109 members completed the matrix, with representation from medical, nursing and allied health professionals. The mean results for each indicator are shown below (maximum 5). Overall results for the different teams varied from 1.2 to 4.2, with standard deviations ranging from 0.4 to 0.8. Conclusions: This matrix has the potential to be a simple, valid and reliable tool for MDTs to measure their performance and monitor improvement over time. The tool will now be refined and then disseminated to a wider audience for further validation and feedback. [Table: see text]
Enrollment barriers of adolescents and young adults (AYA) on the non-chemotherapy arm of ARST1321.
Authors: Kopp Lisa M. , Reed Damon R. , Ahmed Safia K. , Allen-Rhoades Wendy , Avutu Viswatej , Chen Yen-Lin , Davis Lara E. , Eaton Bree Ruppert , Hawkins Douglas S. , Indelicato Daniel J. , Patel Shreyaskumar , Randall R. Lor , Reinke Denise K. , Riedel Richard F. , Scharschmidt Thomas , Thornton Katherine Anne , Wang Dian , Janeway Katherine A. , Weiss Aaron R.
Published: May 2020

e19214

Background: ARST1321(PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib (NCT02180867) was the first National Clinical Trials Network (NCTN) study co-developed by pediatric (COG) and adult (NRG Oncology) consortia anticipating enrollment of adolescent and young adult (AYA) cancer patients. ARST1321 had two treatment cohorts, enrolling patients ≥ 2 years of age to either chemotherapy (C) (chemoradiation ± pazopanib) or non-chemotherapy (NC) (radiation ± pazopanib) arms. It was anticipated adults would contribute the majority of enrollments on the NC arm based on prior enrollment patterns. While the C arm accrued as anticipated (with high enrollment of adults and children), the NC arm had low enrollment leading to premature closure. We report on AYA accrual (defined as 15-39 years) to the NC arm and a survey aiming to identify barriers to enrolling AYA patients onto ARST1321. Methods: Our survey was emailed to 161 adult, surgical, and radiation oncologists at large sarcoma centers. A link was sent to an online questionnaire via SurveyMonkey Inc. and responses were reviewed on their platform. Results: 33 patients enrolled on the ARST1321 NC arm, of which 24% were AYA. 25% of AYA enrollments were from non-COG adult cooperative groups. This trial arm was closed in October 2017 after 3.25 years of accrual below anticipated rates. The survey response rate was 31% with a 70% completion rate. Almost half of respondents were medical oncologists with most seeing 50-200 new sarcoma cases/year at an academic institution and 30% in a pediatric environment (divided equally between radiation and surgical oncologists). 70% of respondents have a joint collaboration with their pediatric oncology team with 23% having a joint clinic. 70% of respondents’ sites opened ARST1321 and anticipated 1-5 patients would be eligible for the NC cohort. However, 42% of respondents’ sites had zero patients enrolled on that arm. The most common reasons for not opening the study and/or not enrolling patients on the NC arm included: lack of interest, disagreement with the therapy, lack of a site investigator, premature study closure, patient/family decision, competing trials, insufficient reimbursement, and regulatory delays. Conclusions: Our survey highlights multiple barriers to enrollment of AYA onto cross-NCTN consortia clinical trials spanning the age spectrum. The information obtained will help inform investigators aiming to effectively design, enroll, and conduct similar trial efforts for AYA in the future.
Clinical trial awareness in oncology patients of diverse ethnic background: A single-institution analysis.
Authors: Valecha Gautam , Thumallapally Nishitha , El Bitar Sandy , Terjanian Terenig O. , Madrigal Louise , Longo Laura , Vaiselbuh Sarah
Published: May 2020

e19217

Background: Clinical trials offer several advantages to the patients including access to innovative treatments with improved survival rates, closer monitoring and follow-up with removal of health disparity; and aim to advance the science of medicine. Yet, worldwide enrollment rates in cancer clinical trials have been only about 5 percent, despite the fact that a significantly higher percentage of Americans have a desire to participate in clinical trials [1, 2]. We conducted a single institution study to gain knowledge about clinical trial awareness in our cancer patient population as well as to identify the barriers within provider-consumer communication that prevent enrollment. Methods: A 10-question survey was distributed by medical assistants and surveys (n=222) were collected at the end of each clinic visit. Responders included racial/ethnic minorities and underserved patients, representative of the ethnic diversity in the Staten Island Borough of New York City. Demographic data including age, gender, zip code, race and ethnicity were recorded. Additionally, Charlson comorbidity index and tumor stage was also recorded. Results: 159/222 patients (71.62%) completed the survey. Of these patients, 47 (29.55%) answered every question on the survey, while 112/159 patients (70.44%) answered only few of the questions. The completed surveys are linked by zip code to the different boroughs of Staten Island, which allows us to identify hubs with lack of clinical trial awareness knowledge. Conclusions: Despite the several advantages for patients and medical field, enrollment rates in clinical trials remain very low. Our study results help in gaining knowledge about clinical trial awareness among oncology patients, correlated to comorbidity and tumor stage. In addition, demographic hubs with lack of knowledge are identified as targets for community outreach and education. A multilevel approach will be developed to address identified barriers that exist for patients, and will be implemented at community level, to reduce ethnic bias in trial enrollment and increase trial participation among an ethnically diverse population. References: 1. Unger JM, Cook E, Tai E, Bleyer A: The Role of Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies. Am Soc Clin Oncol Educ Book. 2016, 35:185-198. 10.1200/EDBK_156686 2. Comis RL, Miller JD, Aldigé CR, Krebs L, Stoval E: Public attitudes toward participation in cancer clinical trials. J Clin Oncol. 2003, 21:830-835. 10.1200/JCO.2003.02.105.
Perceptions of process barriers to lung cancer screening at community oncology programs.
Authors: Sutton Linda , Lotz Lisi , Horn Eileen V. , Pendergraft Trudy
Published: May 2020

e19218

Background: Lung cancer screening (LCS) has potential to detect earlier stage cancer, favorably impacting patient outcomes, however evolving data suggest that LCS is underutilized. Because LCS is an extensive process with diverse barriers specific to each clinical setting, a multidisciplinary quality improvement (QI) initiative was undertaken to develop and test LCS processes to improve effective LCS. Baseline findings and approaches are presented. Methods: To inform the development of effective strategies to improve LCS, a survey was developed to examine perceptions and barriers to LCS across a group of community oncology programs in the Duke Cancer Network (DCN). The survey analyzed contextual, institutional, and patient factors influencing utilization of LCS. Survey results were used to support purpose-driven multidisciplinary teams to develop site-specific improvement plans for LCS with the support of QI consultants from Bite-Size QI. Results: Surveys were sent to 62 administrators and providers at 12 community oncology programs, with 36 respondents across 9 sites. LCS rates ranged between 4%-16% at participating sites. Respondents identified the lack of processes and infrastructure to support LCS as the most common challenges. Processes related to identification of LCS candidates, conduct of shared decision-making (SDM), follow up of lung nodules, and recurring screens were named specifically. Contributing factors identified were lack of robust community outreach, patient education, and protocols for providers. With regard to SDM, both administrators and providers reported systematic issues including provider time constraints and nonexistent or inconsistent identification/tracking systems, with patient compliance and health literacy as further barriers. The lack of these processes not only affected patients receiving initial LCS, but also how recurrent screenings were tracked. Conclusions: Identifying challenges in processes facilitated creation of improvement projects for participating sites. Initial improvement projects focus on patient notification of LCS results through follow up letters, integration of tracking LCS into hospital systems, development of patient education, community outreach and smoking cessation programs. Follow-up analyses will be undertaken to evaluate each approach.
Adherence to post-surgery follow-up assessment and its association with sociodemographic and disease characteristics in patients with breast cancer in China.
Authors: Feng Ran , Jing Jingfeng , Yang Haibo , Zhang Xiaojun , Li Ming , Gao Jinnan
Published: May 2020

e19232

Background: The incidence of breast cancer has increased more than 30% in the past decades in China. Epidemiological studies based on international and Chinese data have showed that breast cancer is the most common in female malignant tumors. Breast cancer patients with early breast cancer have better survival, lower recurrence and metastasis rate due to early diagnosis and improved treatment. As an important element in the comprehensive management of breast cancer patients, follow-up can eliminate treatment-related complications, detect recurrence and metastasis as early as possible, and improve mental health and quality of life. It is increasingly recognized as a distinct phase of cancer care. However, follow-up adherence after breast surgery has not been studied in China. The aim of this study is to investigate the loss of follow-up after breast cancer surgery and its association with patients', tumor and treatment characteristics. Methods: A total of 711 patients underwent surgical treatment in Shanxi Bethune Hospital from March 2012 to May 2018 were included in this study. Baseline socio-demographic, tumor, and treatment characteristics were obtained from the hospital electronic medical records. The post-surgery follow-up was reviewed and assessed from the patients’ follow-up examination record. Factors associated with the first three-year follow-up was evaluated using logistic regression analysis. Results: The annual follow-up rate after surgery decreased gradually from 67.1% at the 1st year, 60.2% at the 3rd year to 51.9% at the 4th year, and 43.5% at the 5th year. Loss of follow-up during the first three years after surgery was significantly associated with older age >65 years(OR=2.34, 95% CI:1.14-4.82), lower medical insurance coverage(OR=4.26, 95%CI:1.77-10.25), axillary lymph node dissection(OR=2.52, 95%CI:1.39-4.55), no chemotherapy(OR=3.55, 95% CI:1.87-6.75) and no radiotherapy(OR=3.85, 95%CI:2.11-7.03). Conclusions: This study indicated that the annual follow-up rate after curative surgery for breast cancer survivors decreased significantly within five years, and that the risk of poor adherence to follow-up examinations was significantly increased in patients aged over 65 years with lower medical insurance coverage, having extensive axillary lymph node dissection, and lack of systematic treatments. These results suggest potential for improving adherence to follow-up in higher-risk subgroups and help clinicians to develop tailored patient management.
Elevating the standard of care: Impact of a regimen-level prior authorization tool on provider adherence to clinical guidelines.
Authors: Brito Rogelio Alberto , Kuklinski Geri , Angelica Patricia , Claussen Anne , Fischer Diana , Yeon Heeseon , Leprai Chiara , Karos Rebecca
Published: May 2020

e19235

Background: New developments in oncology therapy continue to grow in complexity, fueling a dramatically rising cost of care. Traditional care models present opportunities to streamline plan sponsor management efforts, expedite therapy, and improve health outcomes. Studies suggest adherence to evidence-based standards results in higher quality care. Current plan sponsor management platforms match medical policy to individual drugs, not to combination therapy regimens and lack real-time access to standard treatment guidelines. 70% of precertification requests are submitted via antiquated, cumbersome methods such as paper and fax. Methods: CVS Health/Aetna developed a comprehensive oncology solution featuring an enterprise web-based clinical decision support prior authorization tool (Novologix) at the regimen level to reduce administrative burden and support quality care. Novologix regimens were updated via collaboration with the National Comprehensive Cancer Network (NCCN) evidence-based guidelines. Groups also entered a value-based payment (VBP) model to help support quality of care by promoting adherence to NCCN guidelines when clinically appropriate and tool utilization. Eligible members were Commercial, fully-insured members newly diagnosed with breast, colorectal, or lung cancer. Providers were offered dedicated, individual training sessions to provide education on the Novologix tool. NCCN-aligned regimens requested through the platform were automatically certified. Any non-NCCN aligned regimens received accelerated medical review by a board-certified medical oncologist with the option for an external peer-to-peer review upon denial. Providers received ongoing quality and cost of care reporting. Results: Primary in progress. N of precertification requests submitted via Novologix ( 28 requests as of 1/23/2020) - (will include graph displaying N of requests by month). N of regimens submitted via Novologix that were automatically certified (46% as of 1/23). Avg turnaround times for modified regimen requests requiring clinical review (TBD). Avg % adherence to NCCN guidelines (100% as of 1/23/20) Secondary: Total cost of care (preliminary/other leading indicator). Conclusions: By engaging oncology practices through an enhanced payer-provider collaboration and implementing an automated regimen-level precertification process we can facilitate higher-quality oncology care. Future studies will be needed to measure the impact of this program on total cost of care.
Navigating herbal dietary supplements: Oral chemotherapy drug interactions in a community cancer center.
Authors: McCarthy Heather F. , Gomes Bethany F. , Skeffington Patrick John , Cordova Noelle , Huber Olivia , Ward Kristina
Published: May 2020

e19239

Background: The number of FDA-approved oral chemotherapy medications has continued to increase as has their incorporation into cancer treatment plans. Oncology pharmacists play an integral role in assessing and navigating drug interactions for patients. At Southcoast Centers for Cancer Care (SCCC), oncology pharmacists meet with patients to review/counsel on newly initiated oral therapy. One of the areas assessed during the visit is the use of herbal nutritional supplements. Pharmacists utilize available institutional resources to assess potential interactions and collaborate with the University of Rhode Island (URI), Drug Information Services (DIS), when information is not readily available. Methods: Patient responses about utilization of herbal dietary supplements during pharmacist-patient counseling sessions were assessed. All positive responses triggered a drug-supplement interaction screen. Number of patients taking herbal dietary supplements was tabulated and their use was characterized. Results: From October 2016-June 2019, 187 patients were counseled. Of these, 44/187 (24%) were taking herbal dietary supplements. SCCC pharmacists consulted the URI DIS on 10/44 (23%) patients to assist in identifying, researching, and recommending a care plan. The most frequently used supplements were melatonin and marijuana/CBD oil. The most frequently used supplements that required further consultation included curcumin. Conclusions: Consistent with findings from the general population taking prescription medications, we found that approximately 25% of patients taking oral chemotherapeutic medications were also actively taking herbal dietary supplements. Little data exists regarding oral chemotherapy agents and herbal dietary supplement interactions. Careful questioning/review/research of potential interactions is needed to prevent interactions and maximize effectiveness of oral chemotherapy.