bluuebunny/crossref_metadata_2025 huggingface dataset:
What type of feedback to clinicians best improves conformance to supportive care quality measures?
Authors: Kamal Arif , Abernethy Amy Pickar , Bull Janet , Nicolla Jonathan , Kelly Joseph , Stinson Charles Steven , Adams Martha
Published: February 2017

102

Background: Supportive care is under-addressed in oncology and an important area for quality improvement. Regular, directed feedback is an important component of effective quality management. What type of feedback yields the highest conformance to supportive care measures? Methods: Within the Carolinas Palliative Care Consortium, we conducted a series of three PDSA cycles, each one month-long, to evaluate various types of clinician-directed feedback on conformance to two supportive care measures. We collected data using a web-based, mobile health platform called QDACT-PC (Quality Data Collection Tool for Palliative Care). Every four weeks, feedback to clinicians on performance was changed in a stepwise fashion, from “no feedback” to “personal feedback” to “comparative feedback” (personal conformance compared to the rest of the Consortium). We monitored weekly changes to conformance to two quality measures: documentation of timely management of constipation and dyspnea. To meet the measures, symptoms with intensity of >3/10 on the Edmonton Symptom Assessment Scale required documentation of intervention within 24 hours. Conformance rates were calculated and compared to a historical baseline. Results: 23 providers participated in this quality improvement project, which spanned 465 patient encounters across 104 unique patients. Baseline data generated from 3/2008-10/2011 demonstrated baseline conformance to the dyspnea and constipation measures at 6% (27/457) and 4% (14/398), respectively. After addition of an electronic, prospective quality monitoring system alone (QDACT-PC), conformance increased to 93% (42/45) and 92% (23/25), respectively. With personalized, weekly feedback, these rates increased to 94% for dyspnea and 100% for constipation. Feedback comparing personal performance to the average of the rest of the Consortium further increased this to 100% for both. Conclusions: Regular, weekly feedback on performance increases conformance to supportive care quality measures. Adding comparative feedback versus other peers solidifies this effect. Duration of the effect is being evaluated.
Incidence of breast cancer among women in the United States, by human epidermal growth factor receptor-2 status: An analysis of National Registry data 2010.
Authors: Lang Kathy , Hao Yanni , Huang Huan , Federico Victoria , Menzin Joseph
Published: February 2017

112

Background: Few studies of breast cancer (BC) incidence by human epidermal growth factor receptor 2 (HER2) status exist as it is not routinely collected in population-based registries. This study used newly collected registry data to evaluate incidence of BC by HER2 status. Methods: The Surveillance, Epidemiology, and End Results (SEER) Program is a system of tumor registries designed to track cancer incidence and survival, covering about 25% of the US population. The SEER*Stat Database used for this analysis provides summary prevalence/incidence rates, frequencies, and case statistics. We evaluated age-adjusted (to the 2000 US population) incidence (number of cases per 100,000 females) of newly diagnosed female BC during 2010, by HER2 status, stratified by age, race, and stage at diagnosis. Cases with unknown values for any stratifier were excluded. Patients were classified as HER2+/HER2- based on a new HER2 status variable collected beginning in 2010. Results: There were 49,347 cases of newly diagnosed female BC in 2010 (7,331 [14.9%] HER2+ and 42,016 [85.1%] HER2-). Annual incidence of HER2+ BC was lower than incidence of HER2- BC (15.5 vs. 87.9 per 100,000 females; p<0.01). Incidence was highest among patients aged 65-74 years (42.4 [HER2+] and 318.1 [HER2-]), followed by 75+ (34.3 and 292.2), 45-64 (33.7 and 170.4) and under 45 (4.8 and 17.5). Incidence rates by race were as follows: Blacks (17.1 [HER2+] and 83.1 [HER2-]), Whites (15.5 and 91.3), Asian or Pacific Islanders (14.9 and 65.5), and American Indian/Alaska Natives (7.3 and 37.1). Incidence rates were highest for less advanced stages of BC: Stage I (6.1 [HER2+], 45.9 [HER2-]), II (5.5, 28.1), III (2.7, 9.9), and IV (1.2, 4.0). Differences in incidence rates across all strata among HER2+ and HER2- patients were statistically significant (p<0.01). Conclusions: This analysis is among the first to utilize the new SEER HER2 status variable. About 15% of newly diagnosed BC cases reported to SEER in 2010 were HER2+. Differences in incidence across age and stage followed a similar pattern for both HER2+ and HER2- BC, while slight differences by race were observed. Further outcomes studies by HER2 status are warranted.
Assessment of single-institution HER2 testing patterns, rate of HER2+ disease, and utilization of trastuzumab in early breast cancer.
Authors: Stenehjem David D. , Yoo Minkyoung , Unni Sudhir K. , Singhal Mukul , Bauer Hillevi , Saverno Kim , Quah Cheng Seok , Masaquel Anthony , Brixner Diana I.
Published: February 2017

124

Background: Improved outcomes with HER2-directed therapies highlight the importance of standardized testing for HER2 positivity. This study aimed to assess HER2 testing practices, rate of HER2+ disease, and trastuzumab use in early breast cancer (EBC) at the Huntsman Cancer Institute (HCI) a National Cancer Institute-Designated Center and member of the National Comprehensive Cancer Network. Methods: Included patients’ records from the HCI electronic data warehouse (EDW) and the HCI tumor registry were female, age ≥ 18 years, ≥ 2 visits in the EDW and a stage I to IIIa EBC diagnosis from 2005 to 2012. HER2 testing patterns were identified through chart review of pathology and clinical notes in the EDW. HER2+ was defined as either FISH+ or IHC3+. Patient characteristics, HER2+ rate, and trastuzumab use were evaluated descriptively. Discordance rate associated with reflex testing (IHC 2+ retested by FISH) was also evaluated. Results: A total of 1,459 women were included with stage I (49%, n=720), IIa (26%, n=374), IIb (14%, n=197), and IIIa (12%, n=168) EBC. Mean age was 57 years. HER2+ disease was identified in 243 (17%) tumors. Of HER2+ tumors, 104 (43%) were ER+/PR+, 33 (14%) ER+/PR-, 1 (<1%) ER-/PR+, 79 (32%) ER-/PR-, and 26 (11%) unknown. Tumors were first tested for HER2 using: 1,192 (82%) IHC, 36 (3%) FISH, 227 (15%) unknown and 4 (<1%) other tests. First IHC results were scored 0 (23%), 1+ (33%), 2+ (26%), 3+ (17%), and unknown (<1%). Reflex testing within one month was performed in 301/308 (98%) of IHC 2+ tumors. The discordance rate of IHC/FISH was 10%. Trastuzumab was prescribed for 184/243 (76%) women whose tumors were considered HER2+ based on final interpretation and in 1 HER2 equivocal tumor. Documented reasons for lack of trastuzumab use in HER2+ patients (n=59) included low risk of recurrence based on stage or other treatments (n=18), loss to follow-up (n=13), unknown (n=11), not clinically appropriate due to age or comorbidity (n=10), and patient declined (n=7). Conclusions: This is one of few cancer registries assessing the rate of HER2+ disease in EBC. Reflex testing identified additional HER2+ tumors. The HER2+ rate was within range of previously published studies.
Trends in the cost of the futile cancer care near the end of life.
Authors: Lin Wender , Hsieh Chi-Jeng
Published: February 2017

126

Background: Aggressive cancer care near the end of life may not only represent a quality-of-care issue, but also a futility issue. Under the constraint of health resources, it is of interest to know the cost trends of futile treatment for cancer patients near the end of their life. Methods: The definition of potential medical futility for cancer patients near the end of their life was developed based on the RAND/UCLA Appropriateness Method. Nine experts or academics from medical, political, social, or legal fields built a consensus that treatment after 7 days in the intensive care unit following a cardiopulmonary resuscitation for cancer patients who died within 3 months is probably futile. Based on this definition, we used death registry and Taiwan’s National Health Insurance claim data from 2000-2001 and 2009-2010 respectively to estimate the cost of potential futile treatment for cancer patients near the end of their life in 2001 and 2010. Results: The percentage of cancer patients receiving potentially futile treatment near the end of their life reduced from 2.68% in 2001 (883/32,993) to 1.58% in 2010 (649/41,046). The cost of potentially futile cancer care also decreased from $283 million NTD (New Taiwan Dollar) in 2001 to $255 million NTD in 2010 (1USD=30NTD). Nevertheless, the per capita cost of potentially futile cancer care slightly increased from $320 thousand NTD to $393 thousand NTD. Conclusions: Although the cost of potentially futile cancer care for patients near the end of life is not huge in Taiwan, its trend of decrease may indicate that supportive but not aggressive cancer care is more and more prevailing and acceptable by patients, their family, as well as health care providers.
Physician orders for scope of treatment (POST) forms in metastatic cancer patients: A 3-year single-university–institution retrospective review.
Authors: Curley Brendan F. , Khimani Farhad , Moss Alvin Howard
Published: February 2017

133

Background: Physician orders for dcope of treatment (POST) forms are standardized forms for patient preferences for end-of-life care. These forms contain orders by a physician who has identified a patient who is seriously ill with life-limiting progressive, advanced illness. Utilization of the POST form in advanced and metastatic cancer patients has not yet been evaluated. Methods: At West Virginia University/Mary Babb Randolph Cancer Center, we performed an IRB approved retrospective chart review of all patients who died of metastatic or advanced malignancies from 2010-2012. Statistical analysis was performed with SPSS Version 20. Results: 139 patients were identified who were diagnosed with metastatic cancer and treated at West Virginia University who died from 2010-2012. Of those 139 patients, 26 (18.7%) completed POST forms. 51 (36.7%) patients received systemic oncologic treatment in their last thirty days of life. In the last ninety days of life, patients averaged 16.2 days hospitalized. 123 (88.4%) patients had at least one hospital stay in their last three months of life, with 82 (58.7%) having two or more stays. 65 (46.8%) patients had a hospital readmission within thirty days. 39 (28.1%) patients had an ICU stay with an average duration of 2.6 days. Almost half of all patients reviewed (67, 48.2%) died in the hospital. Patients averaged 2.9 CT scans and 5.2 X-rays over the last ninety days of their life. 116 (83.5%) patients had an end-of-life discussion, with an average time from discussion to date of death of 24.5 days. Only 60 (43.2%) were identified as having a palliative care consult completed. Conclusions: The American Society of Clinical Oncology (ASCO) recommends implementation of Palliative Care at the time of diagnosis of advanced cancer. POST forms appear to have a positive impact on end-of-life care in this population of advanced cancer patients. Increasing their implementation in metastatic oncology patients will likely improve end-of-life care. [Table: see text]
The impact of compliance to oncology pathways that include G-CSF rules for use on ER visits/hospitalizations in a multistate program.
Authors: Delgado Andrew , Kim Ted , Kreys Eugene , Koeller Jim M.
Published: February 2017

135

Background: CareFirst BCBS initiated a multistate oncology pathway program in 2008, which reduced chemotherapy and hospitalization expenditures and also increased supportive care drug utilization. This study evaluated the impact of following pathways including supportive care versus not following pathways on ER visits/hospitalizations and associated costs as a result of anemia, neutropenia, and chemotherapy-induced nausea and vomiting (CINV). Methods: The CareFirst claims database was utilized to evaluate data two years after initiation of the pathways program. Frequency of ER visits/hospitalizations for neutropenia, anemia and CINV was the primary outcome measured and was compared between compliant and noncompliant pathway utilization of granulocyte colony-stimulating factors (G-CSFs), erythropoiesis-stimulating agents (ESAs), and antiemetics, respectively. Logistic regression analyses were used to control for expenditures of ESAs, CSFs, and antiemetics in the context of compliance and the corresponding visit types. Costs associated with ER visits/hospitalizations were also compared between compliant and noncompliant pathway utilization of supportive care. Results: Overall, 46 sites with 1,586 patients were evaluated. There were a total of 12 ER visits/hospitalizations for anemia, 231 for neutropenia, and 360 for CINV. G-CSF pathway compliance resulted in a relative reduction in ER visits/hospitalizations of 67.2% (from 28.3% to 11.5%, p<0.001). Logistic regression showed consistent results when controlling for costs with a 69.5% relative reduction of ER visits/hospitalizations (p<0.001). A comparison of ER visits/hospitalization costs as a result of neutropenia demonstrated G-CSF pathway compliance producing an average savings of $1,173 per line of therapy (p=0.001). Analogous analyses did not demonstrate a significant relationship between ESA and antiemetic utilizations and their corresponding ER visits/hospitalizations. Conclusions: Adherence to oncology pathways, including G-CSF use rules, is associated with a significantly lower ER visits/hospitalization rates and costs associated with febrile neutropenia.
Reduction in chemotherapy administered at the end of life (CAEOL) through quality improvement processes in a large community oncology clinic: The West Clinic experience.
Authors: Schwartzberg Lee Steven , Freiden Yonatan , Thul Aaron , Houts Arthur C.
Published: February 2017

159

Background: Giving chemotherapy (CTX) near the end of life is futile and costly in human and financial terms. We analyzed patterns of chemotherapy administered at the end of life (CAEOL) by disease, provider, and line of therapy as part of a broad quality initiative. We hypothesized that measuring CAEOL in our practice could identify modifiable practice patterns. Methods: All patients (pts) with an ICD-9 diagnosis of cancer who died between 1/09 and 6/10 were identified by EMR or by searching SSDI records. We focused on the cohort receiving CTX within 14 or 28 days (d) of death, stratified by tumor type, provider and line of therapy by electronic chart review. Initial results were distributed to practice physicians for review and discussion with a clinic-wide goal to be below 5% and 10% at 14 and 28d, respectively. Subsequent cohorts were then evaluated periodically with results disseminated. Results: There was a 14.5% reduction in CAEOL within 14d and a 25% reduction within 28d over time (Table), meeting the clinic-wide standard. In the 2009-2010 cohort there was a difference in 1st line pts receiving CTX within 28 d for NSCLC (24/56 pts, 42.9%) or pancreas cancer (13/19, 68.4%) and the next 4 most common diagnoses: breast, colorectal, small cell lung, and head and neck cancer (15/84, 17.9%), p= .0024. CAEOL beyond 3rd line in non-breast, or >5th line in breast cancer was uncommon. In the 2013 cohort, 1st line accounted for 28/51 pts (54.9%) receiving CTX within 28 d with NSCLC (8/15), pancreas (3/3) and lymphoma (4/4) the most prevalent diagnoses. Conclusions: CAEOL is a relatively rare event in our practice, now meeting practice standards after measurement and delving into root causes. A certain irreducible number of pts will be treated at the end-of-life, including those with potentially life-prolonging intent. First line therapy represents the majority, so identifying inappropriate candidates at diagnosis remains a quality improvement opportunity. [Table: see text]
Developing and promoting evidence-based use of granulocyte colony stimulating factors (GCSF) in the palliative chemotherapy setting.
Authors: Elfiky Aymen , Kaymakcalan Marina , Stuver Sherri , Sweeney Christopher , Jacobson Joseph O. , Weingart Saul
Published: February 2017

172

Background: National guidelines help define the standard for institutional clinical and insurance coverage policies, butdo not cover all chemo regimens or clinical scenarios. Given high utilization rates of primary granulocyte colony stimulating factors (GCSF) use in metastatic prostate cancer (CaP) patients treated with second-line cabazitaxel chemotherapy, we assessed indications and clinical rationale with goal of developing guidelines for appropriate use of GCSF in this population. Methods: We analyzed existing National Comprehensive Cancer Network (NCCN) and ASCO Myeloid Growth Factors supportive care guidelines as applied to specific chemo regimens, patient and laboratory risk factors (RF). We subsequently examined phase III TROPIC trial data for incidence of neutropenic events in CaP patients treated with cabazitaxel. Additionally, the medical records of the 25 Dana-Farber CaP patients treated with cabazitaxel from 1/2012 through 9/2012 who received primary GCSF prophylaxis were characterized by neutropenia/complications and their RF profiles using existing guidelines. Findings were presented to the genitourinary oncology providers with discussion culminating in consensusrecommendations for GCSF use. Results: Existing guidelines recommend 7 un-weighted factors to consider for GCSF use, in addition to febrile neutropenia (FN) risk > 20% for any chemo regimen. Cabazitaxel is listed as intermediate FN risk (10-20%). Trial data report FN incidence as 7% without primary prophylaxis. The number of NCCN RF for evaluated Dana-Farber CaP patients is represented below. Conclusions: Group consensus considered any of the following to place patients at high risk of neutropenic events: ECOG ≥2; prior episode of FN with any-line chemo; prior neutropenia resulting in treatment delay; and previous radiation comprising >25% bone marrow exposure. Final clinical consensus regarding high risk patients was to consider standard dose cabazitaxel (25mg/m2) with GCSF support versus dose reduced cabazitaxel (20mg/m2) without GCSF. In cases where provider posits there is no compromise of benefit to patient, initial consideration will be for dose reduction. [Table: see text]
Avoiding late-stage colorectal cancer: The outpatient safety net.
Authors: Schottinger Joanne E. , Kanter Michael H. , Smith Andrea
Published: February 2017

177

Background: The Institute of Medicine report "To Err is Human" highlighted two vulnerabilities that introduce possible diagnostic errors — information overload and failure to follow up abnormal cases. The Southern California Permanente Regional Safety Net program was instituted to identify, using electonic medical records, instances where these inadvertent outpatient safety lapses may have occurred and intervene before patient harm develops. A centralized regional team catches the omission and intervenes to ensure necessary follow up care, early diagnosis, treatment monitoring, or preventing harmful interactions from medications. Methods: For colorectal cancer detection and prevention, a safety net system was already in place to ensure the prompt evaluation of a positive fecal occult blood screening test with colonoscopy. However, evaluation of late stages of colorectal cancer at presentation revealed that failure to diagnose/follow up signs of iron deficiency anemia or rectal bleeding (often attributed to hemorrhoids) were opportunities to intervene. The electronic medical record is mined for evidence of iron deficiency anemia in laboratory results or a diagnosis of rectal bleeding that was not followed by a colonoscopy in patients aged 50-75. A list of these patients is reviewed quarterly by a gastroenterologist, who contacts the primary care physician to arrange colonoscopy. Results: During the first six months of the program, 42 patients, aged 52-75, underwent colonoscopy for evaluation of either evidence of iron deficiency anemia or rectal bleeding. Polypectomies were performed in 17 patients (40%) with pathology revealing adenomas in 13 patients and one patient with a bleeding carcinoid tumor. Other findings included hyperplastic polyps, hemorrhoids, diverticular disease, colitis, ulcer, and angiodysplastic lesions. Conclusions: Using an electronic medical record system, an outpatient safety net function allows proactive identification of possible safety issues in the population, helping to avoid late stage diagnoses and adverse outcomes. This system currently encompasses other cancer screening tests, medication monitoring, avoiding harmful medication interactions, and immunizations.
Driving improvement in oncofertility.
Authors: Darland Shelby , Eichmeyer Jennifer N. , Christiaens Kelli , Penchansky Kallie , Betts Michele , Zuckerman Dan Sayam , Beck Thomas M.
Published: February 2017

183

Background: In 2006 the American Society of Clinical Oncology (ASCO) recommended that oncologists discuss infertility as a result of cancer treatment with patients of reproductive age and provide referrals to specialists as needed. Despite these guidelines the majority of cancer centers are not in compliance. Mountain States Tumor Institute (MSTI) piloted a process to improve quality of oncofertility preservation (OP) through identification, documentation, and referral to reproductive specialists. Methods: A physician survey in 2010 indicated that perceived barriers to OP discussion were a lack of accessible materials as well as oversight on the part of the provider. Random chart audits of the Quality Oncology Practice Initiative (QOPI) measures (infertility risks discussed prior to treatment and fertility preservation options discussed/referral to a specialist) occurred biannually at that time. To increase awareness of the data chart audits and reporting shifted to quarterly and included all patients that met OP criteria. Additionally, a committee was formed in 2011 to develop patient/provider packets, collaborate with the local reproductive specialists, and create an OP process. The committee established an OP algorithm involving support staff to flag patients of reproductive age at initial medical oncology consultation and utilizing genetic counselors (GC) and social workers (SW) to expedite and facilitate referrals to reproductive specialists. GC/SW were chosen due to sensitivity with psychosocial issues and to share the additional workload. The OP program was launched in October of 2012. Results: Baseline assessment in 2009 revealed MSTI was compliant 6% and 6%. Six months after program initiation the OP measures improved to 47% and 45% respectively. Notably March and April 2013 showed dramatic improvements with 100% and 75% compliance for both OP measures. Conclusions: It is well known that OP has been a challenge for many cancer centers. This multipronged approach is an example of a novel process implementation that demonstrated significant improvement with the QOPI oncofertility measures. Continued work is needed on improving physician documentation and consistency of OP patient identification.
Managing chemotherapy drug shortages in Ontario.
Authors: Kaizer Leonard , Hertz Sherrie , Yeung Lyndee , Milgram Lisa , Gavura Scott , Iyer Ram , Krzyzanowska Monika K.
Published: February 2017

192

Background: Chemotherapy drug shortages are common and unpredictable. The causes are multifactorial and the negative effects on patients and practitioners have been well described. In an effort to mitigate the impact of this problem, Cancer Care Ontario (CCO) has developed a coordinated approach to the management of chemotherapy drug shortages. Tactics have included a system level strategy to promote communication through a virtual collaborative workspace for providers to network and share management strategies and inventory, where feasible. Disease site experts have also developed clinical guidance for the management of specific drug shortages which have then supported public funding decisions that enabled the use of substitute chemotherapy agents in a number of instances. Methods: The impact and management of a recent shortage of liposomal doxorubicin (LD), a publically funded drug for patients with platinum refractory ovarian cancer is described for both new chemotherapy starts and for prevalent LD treated cases. Expert clinical guidance supported a funding policy amendment so patients already on treatment could switch to a recognized substitute drug, topotecan (TT). This also became the preferred funded option for new platinum refractory patients. Results: LD was in short supply between August 2011 and December 2012. In the quarter prior to shortage, 83 new platinum refractory patients started on LD and 1 on TT. During that time, the average number of monthly prevalent LD and TT treated cases was 80 and 4 respectively. For the first quarter post shortage, 20 new patients started on LD and 34 patients started on TT. The average monthly prevalent treated cases were 49 and 21 respectively. Funding for the switch from LD to TT was requested in only 7 cases. Therefore, the total number of new and prevalent treated cases on either preferred therapy dropped post LD shortage. This decline worsened with each subsequent quarter and immediately returned to baseline when the shortage resolved. Drug procurement costs were lower during the period of shortage. Conclusions: Drug shortages have a significant impact on patients and providers. Even when appropriate substitutes are available, quality of care may be affected.
Pap Hub: A system to improve compliance with pap smear screening guidelines in a large health care system.
Authors: Teoh Deanna Gek Koon , Fall Lisa A. , Beitelspacher Erin A. , Lais Charles W.
Published: February 2017

193

Background: Cervical cancer is the most prevalent gynecologic cancer worldwide, but is third in the U.S. due to pap smear screening. However, American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines are complex and frequently changed, resulting in guideline adherence as low as 33-44%. We describe a centralized pap smear tracking system (“pap hub”) and report preliminary results. Methods: On 1/1/13 we implemented the pap hub, routing all screening pap smear results to a dedicated OB/Gyn nursing staff with a new Epic workbench. Epic Health Maintenance Modifier updated to recommend pap smears for women age 21-65 years (not younger or older per guidelines). Screening Pap/HPV results auto routed to Pap Pool Epic inbasket (not to individual providers). Centralized nurse reviews results alongside past pap results on Pathology flowsheet in Epic If normal Normal history -> appropriate follow-up interval per screening guidelines If abnormal history -> repeat pap as determined by previous history and treatment If abnormal -> manage per ASCCP guidelines Document plan in Epic Result Note Update Epic problems list If Normal: document “Pap Hub Normal History” If Abnormal: document “Pap Hub Abnormal History” with specifics in Overview History Communicate results/plan to the patient. Update Health Maintenance Modifier with next step. Review abnormal results to ensure proper follow-up, with reminders as indicated. Results: Guideline recommendations against pap smears for patients <21 years and >65 years have not changed since 2009. Comparison of first-quarter data for 2010 (pre-Pap Hub) to 2013 (post-Pap Hub) have shown a 63.86% reduction in pap smears in women <21 years. Pap smears in women >65 years has always been low, but has decreased slightly from 2.4% of all pap smears in 2010 to 1.5% of all pap smears in 2013. The 2012 ASCCP guidelines have changed recommended pap smear frequency and abnormal pap smear follow-up, and compliance with these new recommendations is being collected. Conclusions: Pap smear screening has decreased the incidence of invasive cervical cancer in the United States. The Pap Hub, a centralized pap smear tracking system, improves compliance with pap smear screening guidelines.
New tools for enhancing the quality of phase I clinical trials: The Armada and Labtracker computer systems.
Authors: Karp Daniel D. , Falchook Gerald Steven , Subramanian Harihara , Lockett Passion , Harleaux Dina , Fullmer Cheryl , El Osta Badi Edmond
Published: February 2017

235

Background: The MD Anderson Clinical and Translational Research Center (CTRC) focuses on Phase I and early Phase II clinical trials and is managing approximately 156 studies annually. This 18-room combined treatment and laboratory unit manages an average of 12,500 research pharmacologic time points and over 3,000 individual shipments yearly. In FY12, 74% of shipments were done on the day of collection (DOC), whereas 26% of the shipments were shipped periodically as required by the corresponding protocol. All studies are monitored at each step for errors - minor (simple DOC label corrections) or major (improper or missed specimen). Activity is analyzed and reported monthly. Methods: In 2010, to ensure accuracy of timing, collection method, proper storage, specimen condition, and destination accuracy, we developed a robust proprietary Oracle-based laboratory tracking system (LabTracker). In addition, we designed an Advanced Research Management and Data Analysis interface (ARMADA) which provides daily step by step protocol guidance using an innovative color-icon touch-screen display of all required protocol activities for patients in the CTRC. LabTracker contains all auditable items required in the clinical trial and markedly reduces work duplication and handwritten data transcription. We hypothesized that this input system would help decrease errors and improve research quality. Results: In FY10 there were 2,506 DOC shipments with an overall error rate of 3.07%. In FY12 errors decreased to 1.31% out of 3,128 DOC shipments. In FY10, there were 14,507 timepoints with 28 major errors (0.19%). In 2012, with 13,490 timepoints, major errors decreased to 19 (0.076%). LabTracker database also supports billing and has catalogued over 275,000 samples. This system provides real-time accounting and has revolutionized the quality control system of the CTRC as well as the research finance component with 98% charge capture efficiency within 30 days. Conclusions: The LabTracker/ARMADA systems are high volume phase I protocol management tools which have improved quality, decreased redundant work, and support a real time financial management system for complex phase I clinical trials.
SupportScreen: A prospective automated approach to real-time symptom and problem identification, triage, and tailored education.
Authors: Kassab Tricia , Loscalzo Matthew , Clark Karen L. , Alvarnas Joseph C. , Avanessian Priscilla , Levine Alexandra M.
Published: February 2017

240

Background: The links among supportive care services quality of life, patient satisfaction, cost, quality and safety are well established. The Institute of Medicine 2008 report recommended that distress screening be instituted as the standard of cancer care. More recently, ASCO and ACOS created new standards for the universal distress screening. Parallel to this process have been advances in automated technologies that are efficient and easily tailored to the patient population. Methods: SupportScreen is a patient-friendly automated process that identifies, triages and provides educational information all in real time. SupportScreen also facilitates patient, physician and multi-specialist communication and is used to maximize the effectiveness of clinical encounters and overall cancer care. Results: Based on over 15 years of biopsychosocial screening experience, SupportScreen was implemented at the City of Hope as a standard of care in medical oncology, HEM/HCT and surgery outpatient clinics. SupportScreen is also being administered to caregivers and to collect patient satisfaction and research data. In a sample of 4,819 outpatients the top problems rated as high distress are: problems with finances (40%), sleep (38.3%), worry about the future (37.1%), fatigue (36.7%) and side effects of treatments (34.5%). In addition, patients requested assistance (meet with a member of team or educational materials) in many areas related to their quality and coordination of medical care: finances (33.6%), health insurance (27.5%), finding community resources (26.6%), talking with the health care team (26.3%), needing help coordinating my medical care (24%) and transportation (20.7%). Conclusions: Patients and their caregivers have a significant number of unmet needs that may directly impact the quality, safety, and cost of their care. Prospectively managing these barriers may enhance the quality and efficiency of care, especially in those patients who manifest high risk, cost and suffering characteristics.
Building a specialty accountable care organization (ACO) for cancer: Using cost groupers in breast cancer (BC) and malignant hematology (MH).
Authors: Culumber Janene , Kiss Brian , Fernandez Hugo Francisco , Wartenberg Karen , DeMaria Lisa , Shimkhada Riti , Peabody John W.
Published: February 2017

253

Background: New payment models, such as accountable care organizations (ACOs), bundled payments and global budgets will shift some financial risk from payers to providers. The first step in creating a cancer ACO will be to partner with payers to understand aggregate costs over time. Methods: Moffitt Cancer Center (MCC) is partnering with Florida Blue in (BCBS of FL) in developing a specialty ACO strategy for cancer. As an initial step, we created an analytical framework to group and estimate the total costs of cancer care for newly diagnosed breast cancer (BC) and malignant hematology (MH) patients. We used HIPPA-compliant Florida Blue claims billings from 2010-2012 to capture all episodes of care within each calendar year. BC and MH patients were attributed to MCC if they had at least 3 annual visits. Claims from attributed patients were grouped into 7 categories. We calculated the annual costs and the costs by category to generate a Per Member Per Year (PMPY) cost and determine the stability and/or trends in these costs. Results: The PMPY data for the three years (2010, 2011, 2012) were stable over time. Important trends, however, were noted: outpatient (OP) costs, which include infusion chemotherapy, rose similarly (16 and 13%, respectively), inpatient (IP) costs for BC increased 10%, compared to an 8% decrease in IP cost for MH over the 3 years. Physician costs remained stable, consistent with other reports. Conclusions: Moving away from volume-based reimbursement requires building partnerships between payers and providers. We created disease-based cost groupers for two cancer conditions as a first step. Cost trends were stable over time. These findings will give payers and partners confidence to explore ways to improve quality and reducing cost as they consider new arrangements such as a specialty ACO. [Table: see text]
A provider-payor approach for determining value in the health reform era: Early reports on the mQure initiative.
Authors: Letson Douglas D. , Fields Karen K. , Hammon Diane K. , Lee Rachel V. , Peabody John W. , List Alan F.
Published: February 2017

255

Background: Determining value requires detailed measurement of clinical services and associated costs. In the health reform era value demonstration presents a challenge for both providers and payors: providers, unable to demonstrate value, will be unable to attract payors or patients and expand market share; payors, unable to choose the right providers, will lose opportunities to lower costs and raise quality. Methods: In July 2012, the Moffitt Cancer Center (MCC) launched the mQure (MCC – Quality Understanding Research and Evidence) Initiative to (1) measure and improve clinical performance, (2) increase compliance to evidence-based/cost conscious cancer-care pathways, and (3) demonstrate value. We introduced Clinical Performance and Value (CPV) vignettes, a value measurement tool, to measure pathway adherence, determine diagnostic accuracy and appropriate use of diagnostic tools starting with breast and lung cancer. For selected performance items identified by the CPVs, we audited medical records directly. Results: Measurement revealed high value practices, for example, diagnostic accuracy, appropriate rates of biopsy and more accurate staging compared to other groups. Value determination led to one signed plus two pending payor partnerships to implement a shared savings contract, find ways to reduce utilization and explore creating payor-led networks. The focus on individual responsibility for adherence to evidence-based practices has had an unanticipated and seemingly paradoxical benefit of shifting the group to narrow practice variation thereby shifting providers to a more self-aware culture. An external benefit is that the value signal has led to discussions to form accountable care organization (ACO) networks for cancer care. Since mQure’s inception, MCC has created partnerships with 3 hospitals. Based on the breast cancer initiative alone, financial models indicate an estimated savings of up to $2 million annually that arise from higher quality, fewer unnecessary tests and improved pathway compliance. Conclusions: In just one year, the large scale mQure project has led to expanded provider partnerships, new quality-based arrangements with payors and the formation a specialty-ACO.
Impact of Medicare Part D on out-of-pocket drug costs and utilization for patients with cancer.
Authors: Kircher Sheetal Mehta , Johansen Michael , Davis Matthew M.
Published: February 2017

275

Background: Medicare Part D was designed to reduce out of pocket (OOP) costs for Medicare beneficiaries, but the extent to which this occurred for patients with cancer has not been measured. The aim of this study is to quantify the impact of Part D eligibility on OOP cost for prescription drugs and utilization for cancer patients. Methods: Differences-in-differences analyses were used to estimate the effects of Medicare Part D eligibility on OOP drug costs, by comparing 4 year periods before and after Part D implementation. Analyses were based on data from the publicly available Medical Expenditure Panel Survey, a nationally representative, all-payer sample of the United States non-institutionalized civilian population. Our analysis compared per-capita OOP burden between Medicare beneficiaries (age 65+) with cancer to near-elderly individuals age 55-64 years old with cancer. Results: 2,077 near-elderly individuals with cancer and 4,723 individuals with Medicare and cancer were included (total n=6,800), representing over 85 million people. Prescription drug coverage increased among individuals with Medicare from before Part D (39%) to after (65%); in contrast, prescription drug coverage among the near-elderly remained stable before vs. after Part D (82.4% vs. 81.4%). The mean per-capita OOP cost for Medicare beneficiaries with cancer before Part D was $1,111 (SE ±45) and decreased to $694 (±35) after implementation of Medicare Part D—a decline of 37%. Compared with changes in OOP drug costs for non-elderly patients with cancer over the same period, implementation of Medicare Part D was associated with a further reduction of $286 per person. OOP costs for cancer-associated drugs (i.e., antineoplastic, pain medications, anti-emetics) accounted for 6.5-11.1% of the total OOP cost with no significant trends between 2002-2010. Conclusions: The implementation of Medicare D has significantly reduced OOP prescription drug costs for seniors with cancer, beyond trends observed for younger patients. Considering prescription drugs for all medical conditions, cancer associated drugs compose a minority of the cost, highlighting that cancer patients have many comorbid conditions contributing to overall costs.
Development of a capital investment strategy for radiation (RT) equipment in Ontario.
Authors: Gutierrez Eric , Warde Padraig Richard , Belfour-Barnett Dianne , Matheson Garth , Meertens Elaine , Favell Lisa
Published: February 2017

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Background: To ensure appropriate access to radiation treatment (RT) for Ontario cancer patients for the next decade and that future capital investments in radiation equipment are appropriately timed and strategically placed, Cancer Care Ontario (CCO) has updated its RT Capital Investment Strategy. The strategy was designed around 4 core principles: i) recognizing treatment machine capacity should match the demand resulting from increasing cancer incidence rates and increasing utilization rates as per CCO goals; ii) keeping pace with advancing technology; iii) ensuring value for money by maximising the use of current infrastructure; and iv) minimizing costs through centralized planning and procurement processes. Methods: A multidisciplinary provincial expert panel reviewed and revised the planning parameters used to project treatment demand and required capacity (including fractions of RT per treated case, number of cases treated per hour, uptime of treatment units). The panel reviewed current practice, impact of new and emerging treatment technologies and benchmarks from other jurisdictions. To project the future demand for radiation therapy, growth in cancer incidence (by county) as well as modest improvement in RT utilization rates were assumed. Results: Recommendations included: i) moving to 12-hour treatment days in all large centres and on 50% of equipment in centres operating fewer than 6 treatment units; ii) ensuring appropriate funding for the replacement of existing RT equipment; iii) equipping constructed rooms in 4 regional cancer centers – thereby adding 6 linacs; iv) equipping swing bunkers across the province – thereby adding 10 linacs; and v) planning for the construction of new facilities to add RT capacity in 3 regions of the province. Conclusions: Funding to implement recommendations from previous capital investment strategies has resulted in an equitable distribution of RT resources across the province. We believe the planning strategies and recommendations outlined in the strategy will improve access to quality RT care as close to home as feasible for Ontario patients.
Palliative care training: A national survey of U.S. hematology/oncology fellows.
Authors: Curley Brendan F. , Thomas Roby Antony , Wen Sijin , Zhang Jianjun , Abraham Jame , Moss Alvin Howard ,   West Virginia Clinical and Translational Science Institute
Published: February 2017

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Background: The American Society of Clinical Oncology (ASCO) has recommended integration of palliative care into oncology practice at the time of diagnosis of advanced cancer. The attitudes, knowledge, and skills of Hematology/Oncology fellows in palliative medicine to implement this recommendation have not been assessed. Methods: In 2013 we surveyed current US Hematology/Oncology fellows to assess their attitudes and the quality of teaching in palliative care received during fellowship and their perceived preparedness to care for patients at End of Life (EOL). Trainees at all US programs were surveyed via Research Electronic Data Capture. The survey was IRB approved, anonymous and voluntary. Results: 176 surveys were collected. Statistical analysis was performed with t-test for numeric and Fisher’s exact test for categorical variables. 98% of respondents felt that providing care for dying patients was important. 99% indicated that physicians have a responsibility to help patients at EOL. Fellows felt their overall training in fellowship was superior to their quality of training (p<0.0001) or teaching (p <0.0001) on EOL. Pearson correlation showed that those with training in palliative care felt more prepared caring for patients at EOL (p <0.0001). Fellows who had training in palliative care during fellowship (45.4% of those surveyed) felt they had better teaching on managing a patient at EOL than those who did not (p<0.0001). There was no statistical significance noted with self-identified roles of spirituality or religion in attitudes, knowledge, or skills. 64% reported having conducted over ten family meetings regarding EOL. Only 18.9% were supervised (p<0.0001) and only 13.1% were given feedback more than ten times (p<0.0001). 89.7% of fellows surveyed stated they have disagreed with treatment without palliative care on at least one occasion. 40% of respondents did not know how to respond to a request to stop chemotherapy. Conclusions: Hematology/Oncology fellows believe that EOL care is important. Education about EOL is not at the same level of their overall fellowship training despite the recognition of the benefit of palliative care in Oncology. Educational initiatives need to be introduced to improve training on EOL care.
Compliance with evidence-based guidelines for radiation of vertebral metastases.
Authors: Curry Heather A , Forastiere Arlene A. , Jagsi Reshma , Palladino M. Lou
Published: February 2017

36

Background: Evidence based guidelines pertaining to the management of bony metastases have been published. However, up to 30% of oncology treatments deviate from evidence based standards and widespread variations in clinical practice continue to exist. To explore patterns of care in the treatment of vertebral metastases in a group of working age, insured patients, we assessed treatment plans submitted for preauthorization through eviti Connect. Methods: Eviti Connect is a web-based application that enables oncology providers to obtain automated precertification for patients. The platform evaluates treatment plans for consistency with EBM and compliance with payer policies and plan language. All requests for radiation treatment submitted during a two year period from 6/1/11-5/31/13 were reviewed. Peer to peer discussions were conducted in cases that deviated from EBM. Results: A total of 229 cases for the treatment of vertebral metastases were submitted. 46/229 plans (19.8%) did not meet EBM standards. Some cases displayed more than one deviation. Reasons for non-compliance included atypical treatment schedules (8.69%), SRS/SBRT (36.9%), IMRT (32.6%), and IGRT (58.7%). In 26/46 cases (56.5%) the treating physician provided a medical rationale for the deviation. In 9 cases the physician altered the plan to be compliant; in 5 cases the physician did not agree to a change. The most common dose fractionation schedules were 30 Gy/10 fractions (48.9%) and 37.5 Gy/15 fractions (20.5%). 17 cases were treated using 20 Gy/5 fractions and only 2 cases were treated using 8 Gy X 1. Conclusions: Radiation of vertebral metastases was prescribed in accordance with EBM in the majority of cases. The main reasons for deviation were patient-specific issues that justified the medical necessity of the variance. Case review and peer to peer discussion contributed to understanding the rationale for treatment deviation from guidelines and allowed providers to bring plans into compliance with EBM. Overall only 5% of plans were non-evidence based or lacked a medical justification for deviation. Consistent with patterns of care across the US, within this group of patients, single fraction and hypofractionated radiation regimens were underutilized.