bluuebunny/crossref_metadata_2025 huggingface dataset:
Electronic monitoring of patient-reported adherence and symptoms on oral chemotherapy at an academic and a community site.
Authors: Doolin Jim , Roberts Daniel Aaron , Cibotti Christina , Devlin Scott M , Dowling Holly , Seery Virginia , Tocci Noah Xavier , Trillo Kelsey , Wright Danielle , Yenulevich Mary , Zerillo Jessica A. , Shea Meghan
Published: September 2018

283

Background: Monitoring of toxicity and adherence is often lacking for patients recently started on oral chemotherapy. National guidelines recommend active outreach to patients within a week after treatment start. We developed an online tool to actively reach out to patients newly started on oral chemotherapy at one academic medical center and community practice. Methods: A multi-disciplinary team, including patients, developed an online oral chemotherapy adherence, symptom, and financial toxicity assessment tool within REDCap. We implemented this tool for new oral chemotherapy prescriptions in May 2018 in the gastrointestinal oncology group of an academic medical center and a general community practice. To quantify the impact of this tool on symptom management, we completed a retrospective analysis of patients receiving new oral chemotherapy prescriptions at these same sites, in the 13 months immediately preceding clinical implementation of the online tool, May 2017 to May 2018. Results: In the pre-intervention historical cohort (n = 58) the median time to first symptom assessment by a clinician was 7 days (range 1 – 41 days, SD 7 days), median time to identifying a new or worsening symptom was 10 days (range 1-55 days, SD 10 days), and median time to clinical action regarding a new or worsening symptom was 10 days (range 1-104, SD 20 days). Our first intervention patient used the online tool in May 2018 to report symptoms of “nausea and fatigue,” 4 days after starting oral chemotherapy. This resulted in an oncology clinical nurse calling the patient to review symptom management by phone. Conclusions: The median time to first symptom assessment in our historical control cohort is 7 days, with standard deviation of 7 days, suggesting potential room for improvement. Thus far, the online tool has been completed by one patient. Further data will be reported regarding the uptake of this tool, the tool’s impact on quality measures, and patient reported symptoms, adherence, and financial toxicity.
Incidence of diabetes and hyperglycemia among patients receiving glucocorticoids with chemotherapy.
Authors: Zylla Dylan M. , Steele Grant , Gilmore Grace , Davidson Janet , Carlson Anders
Published: September 2018

286

Background: Over 30 million adults in the U.S. have diabetes (DM), 7 million of which are undiagnosed. Patients with DM undergoing cancer treatment have been shown to have increased rates of complications and shorter survival. Patients commonly receive glucocorticoids (GC) with chemotherapy (CT), which may lead to hyperglycemia. Data regarding the optimal approach to screening and outpatient management of patients receiving CT with GC is lacking. We sought to describe the incidence of diabetes, hyperglycemia, and implemented a quality improvement project to refer eligible patients for DM education and management. Methods: We identified 100 patients with cancer starting a new CT regimen including GC. We obtained screening labs, baseline random glucose, HbA1c, and body-mass index (BMI) for each patient prior to starting CT. Follow-up glucose values were obtained with each cycle; patients were followed for a maximum of 3 cycles of CT. Patients with a baseline HbA1c ≥6.5%, a baseline random glucose ≥200mg/dL, follow up glucose ≥200mg/dL, and/or a prior DM diagnosis were referred to the Park Nicollet International Diabetes Center (IDC) to receive DM education and management. Results: 23% of patients had known DM and 17% had known prediabetes prior to their first CT cycle. Baseline HbA1c values were ≥6.5% in 18% of patients, 5.7-6.4% in 39% of patients, and ≤5.6% in 43% of patients. Among the 18 patients with baseline HbA1c ≥6.5%, 13 had known DM, 1 had known prediabetes, and 4 were undiagnosed. 67% of our study population had a baseline BMI ≥25. 12 patients had at least one follow up glucose ≥200mg/dL. Of those 12, 92% had known DM, 67% had a baseline HbA1c ≥6.5%, and 75% had a baseline BMI ≥25. 29 patients met IDC referral criteria, however, only 14 were ultimately seen in consultation. Conclusions: Adding HbA1c to baseline laboratory evaluations identified individuals with undiagnosed DM. DM history, baseline HbA1c, and BMI were associated with hyperglycemic events among patients receiving CT with GC. Future studies are needed to evaluate the impact of DM education and management on both glycemic control and clinical outcomes.
The impact of C1/D1 treatment follow-up calls on emergency room visits for chemotherapy patients.
Authors: Davidson Kimberly
Published: September 2018

289

Background: One of the more challenging aspects of managing patients receiving chemotherapy is to reduce Emergency Room (ER) visits and ultimately hospital readmissions. Patients may not understand who or when to call with issues and may be concerned about reaching their physician or receiving a call back in a reasonable amount of time. Methods: C1/D1 calls were initiated with the Medical Oncology Care Coordinator (CC) staff in August 2017. All patients receiving a C1/D1 dose of a new treatment and change in regimen were called by the CC. During this call, the patient is asked several questions including how they are currently feeling, if they are having any issues as well as reviewing contact information and direction regarding if they have a fever. Re-education was provided to the staff in January 2018 regarding the importance of the calls. Also at this time, the CC were asked to do Nadir calls (repeat call 7-10 days after D1) for those patients who were determined to be high risk (percentage calculated using a toxicity formula). Results: Initially the % of ER visits were reduced after the C1/D1 calls were initiated but then began trending upward again. After re-education and the initiation of the Nadir calls, ER visits again trended down. Conclusions: Increased touch points with patients, including C1/D1 follow up calls, Nadir calls and toxicity checks for high risk patients contributed to a downward trend of treatment patients visiting the ER.[Table: see text]
Successes with and barriers to patient-reported outcome deployment at a comprehensive cancer center.
Authors: McCleary Nadine Jackson , Schrag Deborah , Martin Neil E. , Mahmood Sadiqa , Beyer Elizabeth , Joyce Linda , Martin Shawn , Tulsky James A. , Wolpin Brian M. , Jacobson Joseph O. , Johnson Jason , Hassett Michael J.
Published: September 2018

292

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

299

Background: Advance care planning is an important aspect of providing high quality care to oncology patients. ASCO Quality Oncology Practice Initiative (QOPI) recognizes the importance of advance directive documentation as a quality measure. MOLST forms are often completed to document a patient’s preferences for medical care at the end of life. The primary objective of this study was to improve the MOLST form documentation process in an outpatient solid tumor oncology clinic. Methods: We conducted a survey to identify areas for improvement and created a process map illustrating the complexities of the current MOLST form documentation process. A multidisciplinary team comprised of physicians, nurses, administrative staff, a quality improvement leader and a palliative care expert was created to focus on this initiative. We developed a new process whereby completed MOLST forms were uploaded into the electronic medical record (EMR) system. We implemented the following interventions: 1) made MOLST forms accessible to clinicians; 2) created a centralized location to place MOLST forms; 3) educated oncology staff about the new process; and 4) streamlined the MOLST form scanning process into the EMR. This process was studied during a pilot between January 22, 2018-February 2, 2018. A pre-pilot convenience sample was compared to pilot data. Results: Oncologists identified the need to improve the MOLST form documentation process on the pre-pilot survey. The percentage of completed MOLST forms scanned into the EMR increased from 44.4% (4 out of 9 forms) pre-pilot to 87.5% (7 out of 8 forms) during the pilot (p = 0.06). All of the MOLST forms completed using the new process were scanned into the EMR. Physician satisfaction with the MOLST process increased from 7.1% (2 out of 28 survey respondents) pre-pilot to 87.5% (14 out of 16 survey respondents) post-pilot (p < 0.01). Conclusions: A targeted process to enhance the documentation of completed MOLST forms succeeded and increased physician satisfaction. Further work will need to be performed to better identify oncology patients appropriate for MOLST form discussions.
Advance electronic screening of patients with cancer leveraging a new EHR to increase efficiency of care delivery, driving clinical care pathways in a perioperative anesthesia assessment center (PAAC), at a comprehensive cancer center.
Authors: French Katy E. , Popovich Shannon , Speer B. Bryce , Recinos Iris , Andrabi Tayab
Published: September 2018

308

Background: Most cancer institutions are using electronic health records (EHRs). With MACRA and MIPS, this number will continue to grow. EHR’s can be frustrating as some are seen as more cumbersome than useful to patient care delivery. In 2017, the MD Anderson cancer center (MDACC) PAAC assessed over 20,000 patients. We wanted to demonstrate positive utility of our EHR. We hypothesized that advanced electronic screening of our cancer patients, leveraging a questionnaire embedded in the EHR, could increase efficiency by driving patient specific perioperative care pathways leading to positive patient experience while not negatively affecting our low same day surgery cancellation rate of 2.07%. Methods: In March of 2016, MDACC launched a new EHR and the PAAC commenced an online medical and anesthesia screening questionnaire to be completed via a secure online portal by our cancer patients in advance of the surgery date. The questionnaire was developed and vetted by specialists from many areas including anesthesia, cardiology, internal medicine, and surgery. The answers to these questions were validated by a healthcare provider, and the patient was directed to one of two care pathways. Complex patients were scheduled for an in person clinic assessment prior to surgery and all other patients were scheduled for a phone call assessment. We used reports created within our EHR to track baseline and 2017 data for numbers of patients directed to the 2 different pathways and same day surgery cancellation data throughout this time frame. Results: Using the online patient entered questionnaire, we were able to improve clinic efficiency by implementing two patient care delivery pathways. Using our new EHR we saw an increase of 18.4% in our phone assessment pathway for patients. Patient experience improved as we were able to offer patients more options in the delivery of care saving them time. Conclusions: Use of our new EHR and IT analytics helped drive patient-specific care pathways, improve efficiency and the patient experience. MDACC same day surgery cancellation rate remained 2.07%.
Content evaluation of Watson for Oncology: A feasibility study.
Authors: Keikes Lotte , Medlock Stephanie , van de Berg Daniel , Zhang Shuxin X. , Guicherit Onno Robert , Punt Cornelis J. A. , van Oijen Martijn G.H.
Published: September 2018

325

Background: Digital decision support tools such as Watson offer a promising opportunity to recommend the best cancer treatment to doctors around the globe. Although concordance studies between Watson's recommendations and routine daily practice or expert opinion were reported; scientific papers demonstrating how Watson affects medical decision-making are scarce. The first step of external validation and localization is content evaluation against national guidelines. Therefore, we present a feasibility study of the content evaluation of Watson for Oncology. Methods: We developed synthetic patient cases exhaustively testing the adjuvant treatment of stage I to stage III colon cancer based on relevant patient, clinical and tumor characteristics, and entered these in Watson. We used cross tabulations and a novel scoring system to compare Dutch and NCCN guideline recommendations with Watson’s treatment advice. Our scoring system allows a range from +12 to -12, reflecting the difference between minor disagreement (possible treatment not mentioned) versus serious error (contraindicated treatment was recommended). Treatment options that were contraindicated according to the national guidelines were labeled with a "red flag" if Watson recommended it, and an "orange flag" if Watson considered it. Results: In total, we developed 190 synthetic patient cases (stage I: n = 8; stage II: n = 110; and stage III: n = 72). Overall concordance scores per case for Watson versus Dutch guidelines ranged from a minimum score of -4 (n = 6) to a maximum score of +12 (n = 17) and from -4 (n = 9) to +12 (n = 24) for Watson versus the NCCN guidelines. In total, 69 cases (36%) were labeled with red flags, 96 cases (51%) with orange flags and 25 cases (13%) without flags. For the comparison of Watson with the NCCN guidelines, no red or orange flags were identified. Conclusions: Evaluation of the content of Watson for Oncology against national guidelines is feasible. Overall concordance scores varied considerably between synthetic patient cases. Non-concordance is partially attributable to guideline differences between the United States and The Netherlands. This implies that further adjustments and localization are required before implementation of Watson outside the United States.
The institution of a white cell growth factor appropriate non-use policy for incurable metastatic solid tumors within a community oncology practice.
Authors: Hoverman J. Russell , Turnwald Brian , Garey Jody S. , Hayes Jad , Mann B. Brooke , He Bo , Wilfong Lalan S.
Published: September 2018

33

Background: Texas Oncology (TO) is a community-based practice. with over 250 physicians (MD) who order chemotherapy. In 2015, pegfilgrastim (pgcsf) was the highest individual drug in billed claims. Concurrently, TO was participating in the United Healthcare (UHC) Episode of Care (EOC) program and anticipating the Oncology Care Model. Patient and program expense dictated understanding pgcsf utilization. Methods: Data were obtained in 9/2015 from EOC claims to identify overall and individual pgcsf use in solid tumor metastatic disease (MDx). Chart review was done for the top prescribers. In 3/16, ASCO pgcsf guidelines and TO education materials were emailed to all physicians. In 3/17 appropriate non-use recommendations were communicated and a real-time internal approval process begun. On 10/1/2017, UHC instituted a pgcsf prior authorization (PA) program. Retrospective data from the iKnowMed EHR system was collected in 3-month intervals from April 2016 through March 2018 and evaluated for number of pgcsf administrations at TO for MDx, as well as, administrations/provider/quarter for TO and The US Oncology Network. MDx was defined by any of the following criteria: stage IV at diagnosis (with certain disease exceptions); TNM M value of “1” or “+”; a metastatic line of therapy; evidence of metastatic disease documented within the EHR. Results: Initial survey of EOC claims indicated 16% of patients received pgcsf for MDx. Rates per MD ranged from 0 to 57%. Review of the top users indicated 90% of uses could have been addressed with dose reduction. In the first measured quarter of April to June 2016 to the last, October to December 2017, pgcsf use dropped by 50%. Changes for some diseases were dramatic: Use in colon cancer fell from 132 uses/quarter to a low of 46, and for non-small lung cancer – 80 to 23 respectively. Conclusions: The deadopting of low value care can be challenging. In the case of pgcsf substantial reductions in use were achieved using data and guidelines for education in the setting of value based contracts. Ultimately, the most change was achieved by an internal real time approval process. This was reinforced by a payer PA requirement.
External validation of a screening instrument to identify cardiometabolic predictors of mortality in individuals with cancer.
Authors: Koczwara Bogda , Kaambwa Billingsley , Miller Michelle
Published: September 2018

5

Background: Cancer survivors are at risk of higher mortality from other causes, in particular, cardiovascular and metabolic. We have previously reported on a development of a brief screening instrument to identify cardiometabolic predictors of mortality in older individuals using the Australian Longitudinal Study of Ageing, which showed that age, sex, history of cerebrovascular disease, non-adherence to exercise guidelines, and smoking predicted for mortality(Lim et al. 2017). The objective of this study was to validate our findings using an external database. Methods: Two external validation cohorts of cancer survivors recruited to the Australian Longitudinal Study on Women’s Health study were used: an older group aged between 70 and 75 at time of recruitment (cohort 1) and a younger group aged between 45 and 50 at time of recruitment (cohort 2). These were compared to the original development cohort who were aged 70 years and over at time of recruitment. The Cox proportional hazards model previously estimated in the development cohort was used to predict mortality at 10 years in the validation cohorts. Measures of discrimination and calibration were calculated. Results: There were 1764 and 1833 women in the two validation cohorts and 294 men and women in the original development cohort. Validation cohorts had lower mortality rates (31% and 4% in validation cohorts 1 and 2, respectively, versus 61% in the development cohort) and validation cohort 2 had a higher proportion of individuals reported to have met exercise guidelines (59%) compared to the development cohort (24%) and validation cohort 1 (0.11%). All measures of discrimination for the validation cohorts were within the range of acceptable published estimates. Calibration showed that, overall, the tool had acceptable predictive accuracy but performed best in the good prognostic groups. Conclusions: We have demonstrated that the screening tool developed in older cancer survivors, performs adequately in cohort of younger women cancer survivors although further calibration is needed to improve performance. Further validation in mixed gender cohorts and usability testing are planned.
Utility and factors associated with imaging early-stage breast cancer: Are we choosing wisely?
Authors: Velazquez Manana Ana I. , Nguyen Nina , Rodriguez Bonilla Carlos , Shao Theresa
Published: September 2018

52

Background: Breast cancer (BC) is the most common malignancy in women with estimated care costs of $20.50 billion/year by 2020. In 2012, ASCO released the Choosing Wisely Initiative which recommended against the use of routine imaging in patients with newly diagnosed early stage BC. We examined the adherence rate and factors associated with non-adherence in patients with early stage BC treated within a large health care system. Methods: We identified all women with stage I-II BC diagnosed between January 1, 2014 and December 31, 2015 from the Cancer Registry of Mount Sinai Health System. Demographic, clinical and treatment related factors were collected. Medical records were reviewed to identify patients who had routine staging scan. Data of initial and follow-up imaging over 1-year period were collected. Odds ratios (ORs) and 95% confidence intervals (CIs) were estimated from logistic regression models. Results: Among 733 BC patients, the median age at diagnosis was 58 (range 26-98). One hundred thirty nine patients (19%) had routine imaging with a mean number of initial scans of 1.53 and 59 (42%) patients had at least 1 subsequent scan in the 1-year follow up (range 1-4 scans/year). PET/CT was the most frequent modality, followed by CT. Medical oncologist was the ordering provider in 52% of the cases and surgical oncologist in 44.6%. Routine scan identified no cases of metastatic disease. False-positive findings were identified in 43% and incidental findings in 8% of cases. Total cost of imaging in this group was $4480/patient. Young age ( < 50), TN disease, tumor size > 2cm and positive lymph node were associated with increased staging scan on univariate and multivariate analysis. Conclusions: Our study highlights the prevalence of unnecessary scan in up to 19% of patients with stage I-II BC. Routine imaging resulted in increased radiation exposure and additional cost of $4480/patient. The presence of T2 tumor, positive lymph node, TN disease and young age were associated with increased staging scan. Further educational efforts are needed to avoid unnecessary scans in patients with early stage BC. [Table: see text]
From A to Xeloda: Practical considerations for implementing a chemotherapy regimen ordering system intervention.
Authors: Egan Kathryn , Bell-Brown Ari , Kreizenbeck Karma L. , Watabayashi Kate , Lyman Gary H. , Hershman Dawn L. , Bansal Aasthaa , Barlow William E. , Sullivan Sean D , Ramsey Scott David
Published: September 2018

57

Background: SWOG S1415CD (NCT02728596) is a pragmatic trial comparing outcomes of colony stimulating factor (CSF) use in usual care with care that uses guideline-informed standing CSF orders for protocol chemotherapy regimens. To develop the regimen list, we reviewed, reconciled, and compiled a comprehensive list of 77 NCCN-recognized core regimens and 40 biologic variants for breast, non-small cell, and colorectal cancer, meant to capture a broad population and variety of practices and settings. The 24 intervention sites chose regimens representative of the 3 febrile neutropenia (FN) risk categories (high, intermediate, low) from the list to reconfigure in prescription ordering systems. The current analysis seeks to determine whether providing a comprehensive list of regimens resulted in increased enrollment of patients. Methods: For each site, we compared how many core regimens the site reconfigured to their average weekly rate of enrollment from date of first patient enrolled to 4/1/2018, controlled for cooperative group type and site-reported volume of breast, non-small cell lung, and colorectal cancer patients. For each regimen, we determined its relative popularity by tallying how many sites chose to reconfigure it for the trial. Results: Sites reconfigured an average of 56% (range: 19%-100%) of core regimens on our list. The 18 most popular core regimens chosen by 83-96% of sites provided enrollment coverage across all FN risk categories for all intervention sites and accounted for 91% of enrollment, although enrollment among those regimens varied widely (0-18% of all patients enrolled). Reconfiguring more regimens did not correlate with higher average weekly enrollment (r < 0.1). Conclusions: Studies that wish to limit the number of regimens may want to focus on the most popular regimens as identified by committee or preliminary polling. Starting from a comprehensive set of regimens for a pragmatic trial focusing on chemotherapy ordering systems takes more time to compile and vet, is more difficult to implement in databases, is a burden to sites to review and reconfigure in ordering systems, and does not necessarily translate to increased enrollment rates. Clinical trial information: NCT02728596.
Impact of clinic characteristics on the adoption of a guideline-based standing order algorithm and patient accrual in the pragmatic cluster-randomized trial SWOG S1415CD (NCT02728596).
Authors: Watabayashi Kate , Bell-Brown Ari , Egan Kathryn , Kreizenbeck Karma L. , Lyman Gary H. , Hershman Dawn L. , Bansal Aasthaa , Barlow William E. , Sullivan Sean D , Ramsey Scott David
Published: September 2018

60

Background: The S1415CD intervention requires the integration of guideline-based prescribing recommendations and standing orders for primary prophylactic colony stimulating factors into existing chemotherapy order systems at community practices within the National Cancer Institute’s Community Oncology Research Program. We looked at the impact of clinic level characteristics on the length of time needed to successfully adopt the intervention and subsequent patient accrual. Methods: We calculated the length of time between randomization and intervention completion for each intervention arm clinic and classified them as short onset (2-5 months, N = 5), medium onset (6-8 months, N = 12) or long onset (10-12 months, N = 7). We compared baseline survey responses about clinic characteristics to onset times. Results: Type of EMR software and the number of chemotherapy regimens reconfigured for the trial had no effect on onset time. All short and medium onset clinics placed orders through an EMR, while 5 of 7 long onset clinics used paper orders. Long onset clinics had less reported nurse involvement in the reconfiguration workflow (change initiation, approval, fulfillment and dissemination) at 14% of clinics vs. 25% of medium onset and 75% of short onset clinics. The average weekly patient accrual rates observed after intervention completion were 1.0 in the short onset (range 0.6-1.5), 0.8 in the medium onset (0.2-1.3) and 0.6 in the long onset (0.1-2.0). Conclusions: When recruiting clinics for trials that require health record system changes, it may be helpful to consider aspects of the system modification workflow such as type of hospital departments involved, as clinics with less nursing involvement may take longer to complete the changes. The inclusion of clinics using different EMR software did not impede onset, but clinics using paper may require more time. Length of onset had no meaningful impact on weekly accrual rates; however, it did determine when clinics could start recruitment, affecting the total number of months clinics could recruit during the study accrual period. Clinical trial information: NCT02728596.
Using a pedigree-based questionnaire to improve efficiency in a general oncology genetics clinic.
Authors: Gulvin Joshua Michael , Pass Sarah , De Los Rios Patricia , Ma Hilary Y. , Rieber Alyssa G.
Published: September 2018

66

Background: Genetic counseling has two major components – education and medical history. Our Lyndon B Johnson (LBJ) General Oncology Genetics Clinic includes a diverse patient (pt) group. The majority of pts do not speak English, requiring medical translation, which lengthens encounters. To improve efficiency, a pre-visit genetics questionnaire (GQ) was created to gather pt and family history. Methods: The GQ includes: breast-obstetric history, urologic history, colon history, dermatology, maternal and paternal family history. Between November 2, 2017 and May 10, 2018 pts were contacted before their encounter. The GQ was given to pts, who were encouraged to complete it in advance, return electronically, or bring to the visit. Encounter duration for pts was calculated based on their check in and check out time documented in Epic. A partially completed GQ is defined as leaving a major section blank, like paternal or maternal history. Results: 92 pts were seen in the LBJ Oncology Genetics Clinic. The overall compliance rate for a completed GQ was 37% (Table 1). 51% of the pts were non-English speaking. For pts who completed the GQ, the mean overall cycle time is 55 minutes, which is reduced on average 33.0% compared to those who did not complete the GQ. Encounter duration in minutes, and compliance rate. Conclusions: We demonstrate that using a pedigree-based GQ in an Oncology Genetics Clinic is feasible with non-English speaking pts and can reduce clinic cycle times up to 33%. The greatest reduction in cycle time occurred when a completed GQ was emailed to the clinic. Interestingly, non-English speaking patients had a shorter cycle time compared to English speaking patients, which could be explained by an approximately twice as high compliance rate in the non-English speaking patients, further supporting the association between GQ completion and cycle time reduction. To improve cycle time further, increasing overall compliance rate from 37% provides a future direction.[Table: see text]
Providing oncologic care with access to clinical trials to an underserved and minority population: The Mayo Clinic/Indian Health Service experience.
Authors: Northfelt Donald W. , Chamie Chara , Omar Farhia , Okamoto Janet , Mathews Timothy , Fitch Tom R.
Published: September 2018

79

Background: Novel mechanisms are needed to provide high quality oncologic clinical care and clinical trial access to underserved and minority populations (UMP). UMP are underrepresented in cancer clinical trials, thus limiting the generalizability of the research. As a National Cancer Institute-Comprehensive Cancer Center, Mayo Clinic has the responsibility to ensure that its cancer care reaches a diverse patient population. Mayo Clinic in Arizona developed a clinical oncology practice in collaboration with the US Indian Health Service at Phoenix Indian Medical Center (PIMC), in part to address these needs. The relationship between Mayo and PIMC is invaluable and serves a crucial need in the community. The Mayo consultants serve as staff physicians in the “Oncology Center of Excellence” at PIMC and see 100 – 200 tribal members annually with new diagnoses of cancer or blood disorders. Being onsite at PIMC allows Mayo consultants to integrate seamlessly into the wider PIMC practice. Methods: Descriptive demographic data from the MCA-PIMC clinical practice were obtained from the PIMC practice database 2008 - 2017. Enrollment of MCA-PIMC patients into MCA cancer clinical trials were prospectively enumerated. Results: Between the time period of 2008-2017, 356 breast cancer patients and 259 colorectal cancer patients were seen by Mayo Clinic oncologists and the PIMC nurse practitioner. During the period of 2016-2017, there were 13 clinical trial referrals from PIMC with 8 of those patients being enrolled in Mayo cancer clinical trials. Conclusions: High quality oncologic clinical care can be provided via unique collaborations between academic oncology program and UMP-focused care provider. This mechanism allows access to cancer clinical trial opportunities for UMP. Prior to the established partnership, there were no Native American patients referred to clinical trials from PIMC, showing the critical pathway that has been forged. Importantly, this is the only known program of its kind in the country. By imbedding the cancer provider in the community, we are able to build trust with the underserved community and create a pathway to a quality care and clinical research.
Integrating mental health professionals into the care team to better recognize and manage delirium in hospitalized oncology patients.
Authors: Hooley Joseph , Ralston Laurel , Marcus Joel Daniel , Best Carolyn , Karius Diana , Koniarczyk Heather , Shepherd Corrine , Carrino Cheryl M , Poole Christa
Published: September 2018

83

Background: Delirium is a common neuropsychiatric condition associated with increased morbidity and mortality, length of hospitalization, and distress. The prevalence of delirium in cancer ranges from 10% to 30% in hospitalized patients and up to 85% in terminally ill cancer patients. Rates of delirium on Cleveland Clinic’s inpatient oncology units were lower than expected. Our goal was to integrate mental health professionals into the care team to assist with better recognition and management of delirium. Methods: Education was developed for a range of caregivers, including physicians, nurses, and advanced practice providers. It was facilitated by a psychiatrist, psychologist, and clinical social workers, and included proper identification of both hyper- and hypoactive delirium through use of the Brief Confusion Assessment Method (bCAM) and use of a delirium order set to treat and manage patients identified as positive for delirium. An important component of this education included a proper assessment and comparison of patients’ current mental status compared to their true baseline prior to hospitalization. Additional integration directly into the care team included participation of the psychiatrist, psychologist, and clinical social workers into each team’s multidisciplinary rounds to facilitate discussions around delirium and its appropriate management, and separate targeted rounding which included one-to-one education with front-line caregivers. Results: During the first year of integration, substantial improvements were noted. The percentage of patients identified as positive for delirium through bCAM screening increased from 3.4% to 15.8% after 12 months, and utilization of the delirium order set increased from 11.1% to 58.3%. Additionally, the average nursing unit length of stay (LOS) for delirium-positive patients decreased by more than 2 days compared to baseline. Conclusions: Integration of mental health providers into the care team to assist with recognizing and managing patients with delirium and to provide direct education to front-line caregivers has helped to rapidly improve delirium identification and management for oncology inpatients.
Cost of care for patients with metastatic castration-resistant prostate cancer initiating on docetaxel versus oral targeted therapies in the United States.
Authors: Wu Bingcao , Li Sophia , Tunceli Ozgur , Song Ji , Pericone Chris , Ding Zhijie , Behl Ajay S. , Srivastava Ayush , Dawson Nancy Ann
Published: September 2018

88

Background: Abiraterone acetate + prednisone and enzalutamide are approved oral targeted therapies (OTT) for metastatic castration-resistant prostate cancer (mCRPC) which have significant clinical benefit. However, their impact on healthcare cost relative to docetaxel (DOC) is not well understood. Methods: This retrospective cohort study used combined claims data from Truven MarketScan Commercial and Medicare Supplement Plan databases. Males ≥18 years with ≥1 prostate cancer diagnosis and a subsequent metastasis diagnosis were indexed on the first claim date of DOC or OTT between 1/1/2012 and 12/31/2016. ≥1 claim for an androgen deprivation therapy during the 12-month continuous enrollment period prior to metastasis was required; patients with end stage renal disease or other primary cancer were excluded. All-cause per patient per year (PPPY) costs were estimated in 2016 US dollars. A generalized linear model was used to compare adjusted costs between DOC and OTT cohorts. Results: A total of 1,159 and 200 mCRPC patients initiated on OTT and DOC, respectively. Mean follow up time for both cohorts was 1.2 years. Mean age of OTT patients was 75.1 (Standard Deviation = 10.7) years and mean Quan-Charlson Comorbidity Index (QCI) was 3.2 (1.9). Mean age of DOC patients was 65.9 (9.1) years; mean QCI was 2.9 (1.8). 21% of OTT and 56% of DOC patients were commercially insured. Following treatment initiation, total mean unadjusted all-cause PPPY costs were $144,350 ($80,606) and $137,814 ($84,405) for OTT and DOC cohort, respectively. The primary cost drivers were utilization of treatments indicated for mCRPC, outpatient encounters and inpatient hospitalizations. Total adjusted PPPY costs were higher for OTT than DOC patients ($141,008 vs. $125,318, p = 0.0012), mainly due to higher costs of treatments indicated for mCRPC ($80,443 vs. $55,820, p < .0001). Medical costs (excluding mCRPC treatment) for OTT initiated patients were lower ($54,570 vs. $64,614, p = 0.0128). Conclusions: In a real-world setting, initiation on OTT was associated with higher overall cost of care for mCRPC compared with DOC. However, the cost of medical services was significantly lower when initiated on OTT.
Inclusion of health-related quality-of-life data in oncology drug reimbursement submissions in Canada: A review of submissions to the pan-Canadian Oncology Drug Review.
Authors: Raymakers Adam JN , Regier Dean , Peacock Stuart
Published: September 2018

94

Background: For health technologies, and cancer treatments specifically, economic evaluation is often used to assess the value of new treatments. The preferred approach to economic evaluation is often cost-utility analysis (CUA). In CUA, incremental costs and benefits of a new treatment and a standard of care are calculated with benefits quantified using the quality-adjusted life-year (QALY); the QALY attempts to account for the quantity and quality of life (using a utility weight). The utility weight often comes from a generic, preference-based measure of health-related quality of life (HRQoL), such as the 5-dimension EuroQol measure (EQ-5D). Many submissions for reimbursement by manufacturers, and indeed many clinical trials, still do not include HRQoL data which may result in lower quality submissions and thus, sub-optimal decisions. Methods: We reviewed submissions to the pan-Canadian Oncology Drug Review (pCODR), the body charged with making reimbursement recommendations in Canada. We reviewed submissions from those first recorded (August 2012) to the present (June 2018). Only submissions that were completed (status listed as 'Notification to Implement Issued') were included. Upon completion, three documents are produced by pCODR: the final recommendation from the pCODR Expert Review Committee, the final clinical guidance report, and the final economic guidance report. All three documents were searched for how HRQoL was incorporated into the economic evaluation. Results: In total, 135 submissions were made to pCODR over the period. Of these, 107 (79.3%) had been completed and met the criteria for inclusion. In most studies, the incremental gain in QALYs from the new technology was small (in 2017 submissions the mean QALY gain was 1.1 QALYs). In addition, few studies reported an original measure of HRQoL, with most citing previously completed studies of variable relevance and quality. Conclusions: Our results indicate that manufacturers should improve the collection of HRQoL data of patients alongside clinical trials. This would enhance the focus on patients and improve decision-making around reimbursement of treatments.
Reduced Insulin Receptor Expression and Altered DNA Methylation in Fat Tissues and Blood of Women With GDM and Offspring
Authors: Ott Raffael , Melchior Kerstin , Stupin Jens H , Ziska Thomas , Schellong Karen , Henrich Wolfgang , Rancourt Rebecca C , Plagemann Andreas
Published: September 2018

Context

Altered expression of the insulin receptor (IR) in adipose tissue (AT) could contribute to gestational diabetes mellitus (GDM) etiopathogenesis. Transcriptional regulation via epigenetic mechanisms (e.g., DNA methylation) may play a critical role. However, the human IR promoter DNA methylation patterns and involvement in gene expression are unknown.

Objective

We evaluated IR mRNA and protein expression accompanied by targeted DNA methylation analyses in AT and blood cells of women with GDM and their offspring.

Design

Prospective observational study.

Setting

Academic clinic and research unit.

Participants

GDM-affected (n = 25) and matched control (n = 30) mother-child dyads.

Main Outcome Measures

Maternal IR gene and protein expression in paired subcutaneous (SAT) and visceral adipose tissue samples (VAT). DNA methylation levels in IR promoter and intronic regions in maternal AT and blood cells of mother-offspring pairs.

Results

In SAT and VAT, IR mRNA/protein expressions were significantly reduced in women with GDMs (P < 0.05). The decrease in VAT was more pronounced and independent of maternal body mass index. VAT IR protein levels were inversely associated with key maternal and neonatal anthropometric and metabolic parameters (P < 0.05). DNA methylation patterns were similar across tissues, with significant yet small size alterations between groups in mothers and offspring (P < 0.05).

Conclusion

Decreased IR levels in AT may be a relevant pathogenic factor in GDM, affecting materno-fetal metabolism. Further investigation of causal factors for IR dysregulation is necessary, especially in VAT. Potential functional and/or clinical roles of altered DNA methylation also should be evaluated.
Anesthetic Management of a Pediatric Patient With Bardet-Biedl Syndrome: A Case Report
Authors: Gencol Tuba , Sergin Demet , Balcioglu Taner
Published: September 2018

Bardet-Biedl syndrome is a rare autosomal recessive genetic disorder that affects many organ systems. In cases of Bardet-Biedl syndrome, since the risk of developing inspiratory, cardiovascular, and metabolic problems is high, endotracheal intubation and anesthesia management are difficult. In this report, we present our experience in the management of anesthesia during endoscopic sinus surgery that was performed for the first time on a 6-year-old pediatric patient diagnosed with Bardet-Biedl syndrome.
Metabolic Acidosis in Postsurgical Patient on Canagliflozin and Metformin: A Case Report
Authors: Darwish Ahmed M.
Published: September 2018

Canagliflozin is a novel drug for diabetes mellitus with the mechanisms of inducing glucosuria through inhibition of the sodium-glucose cotransporter 2 in the kidney independent of insulin activity. We are reporting euglycemic ketoacidosis with severe life-threatening metabolic acidosis. The 2 patients described had type 2 diabetes mellitus and were in a state of relative starvation after abdominal surgery. The first patient had been given an oral diet but was restricted with regard to calorie and sugar intake. The second patient had been nil per os since the operation.
Right-to-Left Shunt During Transseptal Mitral Valve-in-Valve Replacement: A Case Report
Authors: Latimer Ryan , Gilly George
Published: September 2018

The following case report details an 88-year-old woman with severe mitral stenosis and moderate mitral regurgitation who presented with worsening dyspnea on exertion. The patient had undergone 4-vessel coronary artery bypass graft and mitral valve replacement 14 years before and was deemed high risk for redo sternotomy. A transseptal mitral valve-in-valve replacement was performed which resulted in intraoperative hypoxia and hypotension after atrial septal defect creation for valve deployment. A right-to-left shunt had developed due to the patient’s underlying pulmonary hypertension. Successful atrial septal defect closure resolved the hypoxia and hypotension. The patient had a brief and uncomplicated postoperative course.
Attitudes toward French Women's Suffrage on the Eve of World War I
Authors: Chenut Helen
Published: September 2018

This article addresses the issue of elite male opinion in France toward women's suffrage on the eve of World War I. It is based on three poorly known sources from the years 1910–13—two published opinion surveys and the entries in an essay contest sponsored by the Académie des Sciences Morales et Politiques—revealing the attitudes of a sample of male social and political elites. Their opinions can be divided into three broad categories: those in favor, those firmly opposed, and those who expressed qualified support. Social conservatism with regard to change in general appeared to be an important element in male resistance. Those opposed or offering only qualified support adopted two major strands of reasoning: the reassertion of hierarchical sexual difference supported by nature, accompanied by the fear of sex warfare; and dissatisfaction with the existing form of “universal” manhood suffrage, leading to a call for electoral reform that would take precedence over any change in women's political status. But a surprising number also appeared uncertain, even ambivalent or ignorant, about the goals of the suffrage movement.

Cet article interroge les opinions des hommes éminents en France sur le suffrage féminin à la veille de la Grande Guerre. L'étude examine trois sources peu connues—deux sondages d'opinion et dix soumissions dans un concours d'essais organisé par l'Académie des sciences morales et politiques—qui forment un échantillon des sentiments des élites sociales et politiques. Il en sort trois catégories principales de l'opinion : les hommes qui soutenaient l'égalité des sexes et les droits politiques des femmes ; ceux qui se montraient résolument contre le suffrage des femmes ; et ceux qui exprimaient leur confusion, ambiguïté, ou encore, ignorance sur la question posée. En fait, on retrouve dans la résistance masculine un conservatisme à l'égard de tout changement social. Les adversaires et ceux qui ont exprimé un soutien limité ont adopté deux types de raisonnement : l'affirmation de la hiérarchie de la différence sexuelle, associée à la peur de la guerre des sexes ; et le mécontentement à l'égard du suffrage « universel » masculin avec la demande de réformer le système électoral avant d'aborder les droits politiques des femmes.