Compromise Treatment Outcomes Research Articles

Case-Control Study of Intra-arterial Verapamil for Intraprostatic Anastomoses to Extraprostatic Arteries in Prostatic Artery Embolization for Benign Prostatic Hypertrophy

PurposeIt is hypothesized that intra-arterial administration of verapamil is a safe and effective way to reverse the flow in intraprostatic anastomoses to extraprostatic arteries without compromising treatment outcomes in prostatic artery embolization (PAE) for benign prostatic hypertrophy (BPH). Materials and MethodsA prospective study of 62 prostate sides in 31 consecutive patients (median age, 66 y; range, 60–71 y) with symptomatic BPH was undertaken. Median prostate volume was 72.4 mL (range, 48.8–85.8 mL), median International Prostate Symptom Score was 21 (range, 15-23), and median urine peak flow rate was 4 mL/s (range, 2–6 mL/s). The arterial anastomoses were classified as types I–III according to vascular morphology. Treatment safety was assessed in terms of adverse events and complications, and treatment effectiveness was assessed in terms of success rate of angiographic flow reversal. ResultsThe PAE procedure was successfully completed in all 31 patients (100%). Adverse events in both groups were transient and mild and did not necessitate prolonged hospitalization. There was no clinical evidence of any significant nontarget ischemic complication in either group. Intraprostatic anastomosis was diagnosed in 19 of 31 patients (61.3%) and 22 of 62 prostate sides (35.5%). Success rates of verapamil treatment were 88.9% overall (20 of 22) and 100% (19 of 19) in type II and III anastomoses. There was no difference between the treatment group and the control group in clinical, urologic, and imaging outcomes of PAE. ConclusionsIntra-arterial verapamil treatment was probably safe and effective in causing flow reversal in type II and III intraprostatic anastomoses and in preventing ischemic complications in PAE for BPH without compromising PAE outcomes.

The prognostic impact of supraclavicular lymph node in N3-IIIB stage non-small cell lung cancer patients treated with definitive concurrent chemo-radiotherapy.

BackgroundThis study aimed to investigate the prognostic impact of supraclavicular lymph node (SCN) metastasis in patients who were treated with definitive chemoradiotherapy for N3-IIIB stage non-small cell lung cancer (NSCLC).ResultsThe 2- and 5-year overall survival (OS) rates were 57.3% and 35.7% in patients without SCN metastasis and 56.4% and 26.7% in patients with SCN metastasis, respectively. The median OS was 34 months in both groups. There was no significant difference in OS between the two groups (p = 0.679). The 2- and 5-year progression-free survival (PFS) rates were 24.1% and 12.6% in patients without SCN metastasis and 18.0% and 16.0% in patients with SCN metastasis, respectively. Patients without SCN metastasis had slightly longer median PFS (10 months vs. 8 months), but the difference was not statistically significant (p = 0.223). In multivariate analysis, SCN metastasis was not a significant factor for OS (p = 0.391) and PFS (p = 0.149).Materials and MethodsThis retrospective analysis included 204 consecutive patients who were treated with chemoradiotherapy for N3-IIIB stage NSCLC between May 2003 and December 2012. A median RT dose of 66 Gy was administered over 6.5 weeks. Of these, 119 patients (58.3%) had SCN metastasis and 85 (41.7%) had another type of N3 disease: mediastinal N3 nodes in 84 patients (98.8%) and contralateral hilar node in one (1.2%). The patients were divided into two groups according to SCN metastasis.ConclusionsSCN metastasis does not compromise treatment outcomes compared to other mediastinal metastasis in the setting of definitive chemoradiotherapy.

Abstract A74: Cancer Care Providers' Perspectives on Medication Adherence for Cancer Patients on Oral Chemotherapeutic Agents: A Qualitative Assessment

Abstract Background: In recent years, the use of oral chemotherapeutic agents (OCAs) to treat cancer have increased greatly and is expected to continue to increase. According to the World Health Organization, non- adherence with OCAs is the most modifiable factor that can compromise treatment outcomes. WHO estimated that only about 50% of patients take their medications as prescribed, however, adherence varies with compliance rates as low as 16%. The objective of this study is to understand cancer care providers' (oncologists, oncology nurse navigators, and oncologist pharmacists) perspectives regarding challenges patients who are on Oral Chemotherapeutic Agents (OCAs) have adhering to their treatment plans as well as facilitators to adherence. Methods: We conducted 2 focus groups (N= 9) and 2 interviews (N=2), January and February 2016, with 11 cancer care providers practicing in a regional Cancer Center in eastern North Carolina (ENC). The cancer care providers were asked to share their experiences with medication adherence of OCAs among their patient population, and discuss individual-level and structural-level factors that might influence sub-optimal adherence among this population. Participants were also asked about effective strategies they use to help their patients with their medication adherence. Results: The results from this study helped identify and understand the unique factors that contribute to non-adherence to OCAs among the cancer patient population served in ENC. The barriers to adherence to OCAs occur at different levels: policy level (i.e. drug costs and insurance related issues), interpersonal level (i.e. social support, provider communication, and complexity of the regimen), and individual level (i.e. patient related characteristics: education level, health literacy level, anxiety level, and older age). The facilitators identified as increasing adherence to OCAs are: multiple levels of education and reinforcement (i.e. face-to-face, using patient portal system, and repetition of information by cancer care team), social support networks, reminder systems, and nurse navigation program. Cancer care providers reported that utilizing multiple strategies were the most effective in increasing medication adherence among their patient population. Conclusion: This study has identified some modifiable barriers that can help increase medication adherence at multiple levels. The next phase of this study will use results from the formative research phase (identified barriers and facilitators) to develop a tailored nurse coaching intervention component that will significantly improve medication adherence among patients who are at high-risk for non-adherence. Supported in part by a research grant from Investigator-Initiated Studies Program of Merck Sharp & Dohme Corp. The opinions expressed in this abstract are those of the authors and do not necessarily represent those of Merck Sharp & Dohme Corp. Citation Format: Essie Torres, Alice Richman, Shawna O'Rorke, Paige Field, Lauren Carlston. Cancer Care Providers' Perspectives on Medication Adherence for Cancer Patients on Oral Chemotherapeutic Agents: A Qualitative Assessment. [abstract]. In: Proceedings of the Ninth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2016 Sep 25-28; Fort Lauderdale, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2017;26(2 Suppl):Abstract nr A74.

Treatment delay and the risk of relapse in pediatric acute lymphoblastic leukemia

ABSTRACTDelays or interruptions in chemotherapy due to toxicity such as neutropenia or severe infections are common in the treatment of pediatric acute lymphoblastic leukemia (ALL). Based on the reports of worse outcomes in children with poorer compliance with therapy, there has been concern that toxicity-induced therapy interruptions could also compromise treatment outcome. In a retrospective study of treatment delays in our hospital between 2003 and 2013, the case notes of 141 patients were reviewed. The cumulative lengths of delays during the whole length of chemotherapy, during the intensive phase of treatment, and during maintenance treatment were analyzed. Within these categories, delays were split between less and more than the median value. The risk of relapse did not differ between patients with a longer or shorter delay during the total length of treatment or during the intensive phase. In addition, there was a trend when comparing patients above vs below the mean in length of treatment delays during maintenance, and there was a statistically significant difference in relapses when comparing patients in the lowest and highest quartiles of maintenance delays, with fewer relapses among those patients in the highest quartile for treatment delays.

High self-reported non-adherence to antiretroviral therapy amongst adolescents living with HIV in Malawi: barriers and associated factors.

Introduction: Globally adolescents and young adults account for more than 40% of new HIV infections, and HIV-related deaths amongst adolescents increased by 50% from 2005 to 2012. Adherence to antiretroviral therapy (ART) is critical to control viral replication and preserve health; however, there is a paucity of research on adherence amongst the growing population of adolescents living with HIV/AIDS (ALHIV) in Southern Africa. We examined levels of self-reported ART adherence, barriers to adherence, and factors associated with non-adherence amongst ALHIV in Malawi.Methods: Cross-sectional study of 519 ALHIV (12–18 years) attending two large HIV clinics in central and south-eastern Malawi. Participants self-reported missed doses (past week/month), barriers to adherence, and completed questionnaires on past traumatic events/stressors, disclosure, depression, substance use, treatment self-efficacy, and social support. Biomedical data were retrieved from existing medical records. Multivariate logistic regression was performed to identify factors independently associated with self-reported ART adherence (7 day recall).Results: The mean age of participants (SD) was 14.5 (2) years and 290 (56%) were female. Of the 519 participants, 153 (30%) reported having missed ART doses within the past week, and 234 (45%) in the past month. Commonly reported barriers to adherence included forgetting (39%), travel from home (14%), busy with other things (11%), feeling depressed/overwhelmed (6%), feeling stigmatized by people outside (5%) and within the home (3%). Factors found to be independently associated with missing a dose in the past week were drinking alcohol in the past month (OR 4.96, 95% CI [1.41–17.4]), missed clinic appointment in the past 6 months (OR 2.23, 95% CI [1.43–3.49]), witnessed or experienced violence in the home (OR 1.86, 95% CI [1.08–3.21]), and poor treatment self-efficacy (OR 1.55 95% CI [1.02–2.34]). Sex and age were not associated with adherence.Conclusions: In our study, nearly half of all ALHIV reported non-adherence to ART in the past month. Violence in the home or alcohol use in the past year as well as poor treatment self-efficacy were associated with worse adherence. Sub-optimal adherence is a major issue for ALHIV and compromise treatment outcomes. Programmes specifically tailored to address those challenges most pertinent to ALHIV may help improve adherence to ART.

Association of ATP-binding cassette sub-family B member 1 gene C3435T polymorphism with neutropenia in breast cancer patients treated with chemotherapy

Background: Neutropenia is the most common adverse event of breast cancer chemotherapy which can be life threatening due to opportunistic infection, neutropenic episodes may lead to delay or reduction of drug doses which may compromise treatment outcomes. In this study, we investigated the association of ATP-binding cassette sub-family B member 1 (ABCB1) gene C3435T polymorphism with the grading of neutropenia in breast cancer patients who treated with doxorubicin-taxan.Methods: 72 Indonesian female breast cancer patients from Haji Adam Malik Hospital who had been diagnosed and treated with doxorubicin-taxane regimen were selected for this cohort study. DNA was extracted from peripheral leucocytes and ABCB1 C3435T polymorphism was analyzed with PCR-RFLP. Patient data were collected from patient’s medical record for 3 cycles of chemotherapy. Association between ABCB1 C3435T polymorphism with neutropenia was assessed using Kruskal-Wallis test. Decline of absolute neutrophil count was assessed using Wilcoxon test. Genotype deviation and allele frequencies were also determined by Hardy-Weinberg Equilibrium.Results: The frequencies of ABCB1 C3435T genotype for wildtype (CC), heterozygous (CT) and homozygous mutant (TT) was 22 (30.6%), 38 (52.8%) and 12 (16.7%) respectively. No association were found between ABCB1 C3435T polymorphism and the grading of neutropenia (p>0.05). There was a difference on the average of absolute neutrophil count after the first chemotherapy and after the third chemotherapy (p<0.05). There was no significant deviation of allele and genotype frequency from Hardy-Weinberg Equilibrium.Conclusion: ABCB1 C3435T polymorphism had no association with the grading of neutropenia in breast cancer patients treated with doxorubicin-taxane regimen, however there was a trend of absolute neutrophil count declining during the 3 cycles of chemotherapy.

Post-Procedure Evaluation of Microwave Ablations of Hepatocellular Carcinomas Using Electrode Displacement Elastography

Microwave ablation has been used clinically as an alternative to surgical resection. However, lack of real-time imaging to assess treated regions may compromise treatment outcomes. We previously introduced electrode displacement elastography (EDE) for strain imaging and verified its feasibility in vivo on porcine animal models. In this study, we evaluated EDE on 44 patients diagnosed with hepatocellular carcinoma, treated using microwave ablation. The ablated region was identified on EDE images for 40 of the 44 patients. Ablation areas averaged 13.38 ± 4.99 cm2 on EDE, compared with 7.61 ± 3.21 cm2 on B-mode imaging. Contrast and contrast-to-noise ratios obtained with EDE were 232% and 98%, respectively, significantly higher than values measured on B-mode images (p < 0.001). This study indicates that EDE is feasible in patients and provides improved visualization of the ablation zone compared with B-mode ultrasound.

Adding a single low-dose of primaquine (0.25mg/kg) to artemether-lumefantrine did not compromise treatment outcome of uncomplicated Plasmodium falciparum malaria in Tanzania: a randomized, single-blinded clinical trial.

BackgroundThe World Health Organization (WHO) recently recommended the addition of a single low-dose of the gametocytocidal drug primaquine (PQ) to artemisinin-based combination therapy (ACT) in low transmission settings as a component of pre-elimination or elimination programmes. However, it is unclear whether that influences the ACT cure rate. The study assessed treatment outcome of artemether-lumefantrine (AL) plus a single PQ dose (0.25 mg/kg) versus standard AL regimen for treatment of acute uncomplicated Plasmodium falciparum malaria in Tanzania.MethodsA randomized, single-blinded, clinical trial was conducted in Yombo, Bagamoyo district, Tanzania. Acute uncomplicated P. falciparum malaria patients aged ≥1 year, with the exception of pregnant and lactating women, were enrolled and treated with AL plus a single PQ dose (0.25 mg/kg) or AL alone under supervision. PQ was administered together with the first AL dose. Clinical and laboratory assessments were performed at 0, 8, 24, 36, 48, 60, and 72 h and on days 7, 14, 21, and 28. The primary end-point was a polymerase chain reaction (PCR)-adjusted adequate clinical and parasitological response (ACPR) on day 28. Secondary outcomes included: fever and asexual parasitaemia clearance, proportion of patients with PCR-determined parasitaemia on day 3, and proportion of patients with Pfmdr1 N86Y and Pfcrt K76T on days 0, 3 and day of recurrent infection.ResultsOverall 220 patients were enrolled, 110 were allocated AL + PQ and AL, respectively. Parasite clearance by microscopy was fast, but PCR detectable parasitaemia on day 3 was 31/109 (28.4 %) and 29/108 (26.9 %) in patients treated with AL + PQ and AL, respectively (p = 0.79). Day 28 PCR-adjusted ACPR and re-infection rate was 105/105 (100 %) and 101/102 (99 %) (p = 0.31), and 5/107 (4.7 %) and 5/8 (4.8 %) (p = 0.95), in AL + PQ and AL arm, respectively. There was neither any statistically significant difference in the proportion of Pfmdr1 N86Y or Pfcrt K76T between treatment arms on days 0, 3 and day of recurrent infection, nor within treatment arms between days 0 and 3 or day 0 and day of recurrent infection.ConclusionThe new WHO recommendation of adding a single low-dose of PQ to AL did not compromise treatment outcome of uncomplicated P. falciparum malaria in Tanzania.Trial registration number NCT02090036Electronic supplementary materialThe online version of this article (doi:10.1186/s12936-016-1430-3) contains supplementary material, which is available to authorized users.

Genital Shedding of Resistant Human Immunodeficiency Virus-1 Among Women Diagnosed With Treatment Failure by Clinical and Immunologic Monitoring.

Background. The accumulation of human immunodeficiency virus (HIV) resistance mutations can compromise treatment outcomes and promote transmission of drug-resistant virus. We conducted a study to determine the duration and evolution of genotypic drug resistance in the female genital tract among HIV-1-infected women failing first-line therapy. Methods. Treatment failure was diagnosed based on World Health Organization (WHO) clinical or immunologic criteria, and second-line therapy was initiated. Stored plasma and genital samples were tested to determine the presence and timing of virologic failure and emergence of drug resistance. The median duration of genital shedding of genotypically resistant virus prior to regimen switch was estimated. Results. Nineteen of 184 women were diagnosed with treatment failure, of whom 12 (63.2%) had confirmed virologic failure at the switch date. All 12 women with virologic failure (viral load, 5855-1 086 500 copies/mL) had dual-class resistance in plasma. Seven of the 12 (58.3%) had genital HIV-1 RNA levels high enough to amplify (673-116 494 copies/swab), all with dual-class resistance. The median time from detection of resistance in stored samples to regimen switch was 895 days (95% confidence interval [CI], 130-1414 days) for plasma and 629 days (95% CI, 341-984 days) for genital tract secretions. Conclusions. Among women diagnosed with treatment failure using WHO clinical or immunologic criteria, over half had virologic failure confirmed in stored samples. Resistant HIV-1 RNA was shed in the genital tract at detectable levels for ≈1.7 years before failure diagnosis, with steady accumulation of mutations. These findings add urgency to the ongoing scale-up of viral load testing in resource-limited settings.

Identifying and ranking implicit leadership strategies to promote evidence-based practice implementation in addiction health services

BackgroundDespite a solid research base supporting evidence-based practices (EBPs) for addiction treatment such as contingency management and medication-assisted treatment, these services are rarely implemented and delivered in community-based addiction treatment programs in the USA. As a result, many clients do not benefit from the most current and efficacious treatments, resulting in reduced quality of care and compromised treatment outcomes. Previous research indicates that addiction program leaders play a key role in supporting EBP adoption and use. The present study expanded on this previous work to identify strategies that addiction treatment program leaders report using to implement new practices.MethodsWe relied on a staged and iterative mixed-methods approach to achieve the following four goals: (a) collect data using focus groups and semistructured interviews and conduct analyses to identify implicit managerial strategies for implementation, (b) use surveys to quantitatively rank strategy effectiveness, (c) determine how strategies fit with existing theories of organizational management and change, and (d) use a consensus group to corroborate and expand on the results of the previous three stages. Each goal corresponded to a methodological phase, which included data collection and analytic approaches to identify and evaluate leadership interventions that facilitate EBP implementation in community-based addiction treatment programs.ResultsFindings show that the top-ranked strategies involved the recruitment and selection of staff members receptive to change, offering support and requesting feedback during the implementation process, and offering in vivo and hands-on training. Most strategies corresponded to emergent implementation leadership approaches that also utilize principles of transformational and transactional leadership styles. Leadership behaviors represented orientations such as being proactive to respond to implementation needs, supportive to assist staff members during the uptake of new practices, knowledgeable to properly guide the implementation process, and perseverant to address ongoing barriers that are likely to stall implementation efforts.ConclusionsThese findings emphasize how leadership approaches are leveraged to facilitate the implementation and delivery of EBPs in publicly funded addiction treatment programs. Findings have implications for the content and structure of leadership interventions needed in community-based addiction treatment programs and the development of leadership interventions in these and other service settings.

Lowering the Cumulative Central Dose Using Midline Block According to Tumor Response May Reduce Rectal Toxicity Without Compromising Treatment Outcome in Definitive Radiation Therapy for Uterine Cervical Cancer Patients

Lowering the Cumulative Central Dose Using Midline Block According to Tumor Response May Reduce Rectal Toxicity Without Compromising Treatment Outcome in Definitive Radiation Therapy for Uterine Cervical Cancer Patients

De-escalation of the cumulative central radiation dose according to the tumor response can reduce rectal toxicity without compromising the treatment outcome in patients with uterine cervical cancer

ObjectiveTo assess the treatment outcome and toxicity of a low cumulative central dose using a midline block (MLB) during external beam radiotherapy (EBRT). MethodsBetween January 1988 and December 2010, 1559 patients with FIGO stage IB–IIB uterine cervical cancer that underwent EBRT and high-dose-rate intracavitary brachytherapy (HDR-ICBT) were retrospectively analyzed. During EBRT, MLB was performed (n=1195, MLB group) when a sufficient response was achieved to insert the tandem through the cervical canal and place ovoids in the vaginal cavity. MLB was not applied for patients with a slow tumor response (n=364, non-MLB group). The doses were estimated according to the International Commission on Radiation Units and Measurements (ICRU) points. The biologically equivalent dose in 2-Gy fractions (EQD2) was calculated to estimate the cumulative dose from EBRT and ICBT. ResultsEQD2pointA, EQD2rectum, and EQD2bladder were all significantly lower in the MLB group (all P<0.05). The 10-year grade≥2 late rectal toxicity rate was significantly lower in the MLB group (P=0.012), while there was no significant difference in late genitourinary and small bowel toxicity. ICRU rectal and bladder doses showed significant predictability on late rectal and bladder toxicities. After propensity score matching, all patient and tumor characteristics were well matched and the survival and recurrence rates between the two groups were similar (all P>0.05), despite the lower EQD2pointA in the MLB group (P<0.001). ConclusionsApplying MLB according to tumor response during EBRT lowered the cumulative central dose and reduced late rectal toxicity without compromising treatment outcome.

TU‐AB‐BRD‐02: Failure Modes and Effects Analysis

Current quality assurance and quality management guidelines provided by various professional organizations are prescriptive in nature, focusing principally on performance characteristics of planning and delivery devices. However, published analyses of events in radiation therapy show that most events are often caused by flaws in clinical processes rather than by device failures. This suggests the need for the development of a quality management program that is based on integrated approaches to process and equipment quality assurance. Industrial engineers have developed various risk assessment tools that are used to identify and eliminate potential failures from a system or a process before a failure impacts a customer. These tools include, but are not limited to, process mapping, failure modes and effects analysis, fault tree analysis. Task Group 100 of the American Association of Physicists in Medicine has developed these tools and used them to formulate an example risk‐based quality management program for intensity‐modulated radiotherapy. This is a prospective risk assessment approach that analyzes potential error pathways inherent in a clinical process and then ranks them according to relative risk, typically before implementation, followed by the design of a new process or modification of the existing process. Appropriate controls are then put in place to ensure that failures are less likely to occur and, if they do, they will more likely be detected before they propagate through the process, compromising treatment outcome and causing harm to the patient. Such a prospective approach forms the basis of the work of Task Group 100 that has recently been approved by the AAPM. This session will be devoted to a discussion of these tools and practical examples of how these tools can be used in a given radiotherapy clinic to develop a risk based quality management program.Learning Objectives: Learn how to design a process map for a radiotherapy process Learn how to perform failure modes and effects analysis analysis for a given process Learn what fault trees are all about Learn how to design a quality management program based upon the information obtained from process mapping, failure modes and effects analysis and fault tree analysis. Dunscombe: Director, TreatSafely, LLC and Center for the Assessment of Radiological Sciences; Consultant to IAEA and VarianThomadsen: President, Center for the Assessment of Radiological SciencesPalta: Vice President of the Center for the Assessment of Radiological Sciences

The utility of gingival crevicular fluid matrix metalloproteinase-8 response patterns in prediction of site-level clinical treatment outcome.

Different gingival crevicular fluid (GCF) matrix metalloproteinase (MMP)-8 response patterns were studied among non-smoking and smoking patients with chronic periodontitis (CP) and generalized aggressive periodontitis (GAgP) to test the utility of GCF MMP-8 levels predicting the site-level treatment outcome. Data from four independent longitudinal studies were combined. Altogether, the studies included 158 periodontal sites from 67 patients with CP and 32 patients with GAgP, and GCF samples were collected at baseline, after the treatment, and during the 6-month maintenance period. All GCF samples were analyzed by immunofluorometric assay for MMP-8. Different site-level MMP-8 response patterns were explored by the cluster analysis. Most optimal MMP-8 cutoff levels were searched with receiver operating characteristic analyses, and the predictive utility of defined levels was tested. Distinct types of MMP-8 response patterns were found in both smokers and non-smokers. MMP-8 levels exceeding the optimal cutoff levels separately defined for smokers and non-smokers indicated increased risk for compromised treatment outcome at baseline and during the maintenance period. Seventy-one percent of non-smokers (positive likelihood ratio of 4.22) and 88% of smokers (positive likelihood ratio of 5.00) with positive test results at both baseline and the maintenance period had compromised treatment outcome. The double-positive result indicated 46% and 39% point risk increase for the compromised outcome, respectively. GCF MMP-8 analysis with defined cutoff levels could be used to predict the site-level treatment outcome and for longitudinal monitoring of the disease status during the maintenance period.

TU‐AB‐BRD‐04: Development of Quality Management Program

Current quality assurance and quality management guidelines provided by various professional organizations are prescriptive in nature, focusing principally on performance characteristics of planning and delivery devices. However, published analyses of events in radiation therapy show that most events are often caused by flaws in clinical processes rather than by device failures. This suggests the need for the development of a quality management program that is based on integrated approaches to process and equipment quality assurance. Industrial engineers have developed various risk assessment tools that are used to identify and eliminate potential failures from a system or a process before a failure impacts a customer. These tools include, but are not limited to, process mapping, failure modes and effects analysis, fault tree analysis. Task Group 100 of the American Association of Physicists in Medicine has developed these tools and used them to formulate an example risk‐based quality management program for intensity‐modulated radiotherapy. This is a prospective risk assessment approach that analyzes potential error pathways inherent in a clinical process and then ranks them according to relative risk, typically before implementation, followed by the design of a new process or modification of the existing process. Appropriate controls are then put in place to ensure that failures are less likely to occur and, if they do, they will more likely be detected before they propagate through the process, compromising treatment outcome and causing harm to the patient. Such a prospective approach forms the basis of the work of Task Group 100 that has recently been approved by the AAPM. This session will be devoted to a discussion of these tools and practical examples of how these tools can be used in a given radiotherapy clinic to develop a risk based quality management program.Learning Objectives: Learn how to design a process map for a radiotherapy process Learn how to perform failure modes and effects analysis analysis for a given process Learn what fault trees are all about Learn how to design a quality management program based upon the information obtained from process mapping, failure modes and effects analysis and fault tree analysis. Dunscombe: Director, TreatSafely, LLC and Center for the Assessment of Radiological Sciences; Consultant to IAEA and VarianThomadsen: President, Center for the Assessment of Radiological SciencesPalta: Vice President of the Center for the Assessment of Radiological Sciences

TU-AB-BRD-01: Process Mapping

Current quality assurance and quality management guidelines provided by various professional organizations are prescriptive in nature, focusing principally on performance characteristics of planning and delivery devices. However, published analyses of events in radiation therapy show that most events are often caused by flaws in clinical processes rather than by device failures. This suggests the need for the development of a quality management program that is based on integrated approaches to process and equipment quality assurance. Industrial engineers have developed various risk assessment tools that are used to identify and eliminate potential failures from a system or a process before a failure impacts a customer. These tools include, but are not limited to, process mapping, failure modes and effects analysis, fault tree analysis. Task Group 100 of the American Association of Physicists in Medicine has developed these tools and used them to formulate an example risk-based quality management program for intensity-modulated radiotherapy. This is a prospective risk assessment approach that analyzes potential error pathways inherent in a clinical process and then ranks them according to relative risk, typically before implementation, followed by the design of a new process or modification of the existing process. Appropriate controls are then put in place to ensure that failures are less likely to occur and, if they do, they will more likely be detected before they propagate through the process, compromising treatment outcome and causing harm to the patient. Such a prospective approach forms the basis of the work of Task Group 100 that has recently been approved by the AAPM. This session will be devoted to a discussion of these tools and practical examples of how these tools can be used in a given radiotherapy clinic to develop a risk based quality management program. Learning Objectives: 1. Learn how to design a process map for a radiotherapy process 2. Learn how to perform failure modes and effects analysis analysis for a given process 3. Learn what fault trees are all about 4. Learn how to design a quality management program based upon the information obtained from process mapping, failure modes and effects analysis and fault tree analysis. Dunscombe: Director, TreatSafely, LLC and Center for the Assessment of Radiological Sciences; Consultant to IAEA and Varian Thomadsen: President, Center for the Assessment of Radiological Sciences Palta: Vice President of the Center for the Assessment of Radiological Sciences

TU‐AB‐BRD‐03: Fault Tree Analysis

Current quality assurance and quality management guidelines provided by various professional organizations are prescriptive in nature, focusing principally on performance characteristics of planning and delivery devices. However, published analyses of events in radiation therapy show that most events are often caused by flaws in clinical processes rather than by device failures. This suggests the need for the development of a quality management program that is based on integrated approaches to process and equipment quality assurance. Industrial engineers have developed various risk assessment tools that are used to identify and eliminate potential failures from a system or a process before a failure impacts a customer. These tools include, but are not limited to, process mapping, failure modes and effects analysis, fault tree analysis. Task Group 100 of the American Association of Physicists in Medicine has developed these tools and used them to formulate an example risk‐based quality management program for intensity‐modulated radiotherapy. This is a prospective risk assessment approach that analyzes potential error pathways inherent in a clinical process and then ranks them according to relative risk, typically before implementation, followed by the design of a new process or modification of the existing process. Appropriate controls are then put in place to ensure that failures are less likely to occur and, if they do, they will more likely be detected before they propagate through the process, compromising treatment outcome and causing harm to the patient. Such a prospective approach forms the basis of the work of Task Group 100 that has recently been approved by the AAPM. This session will be devoted to a discussion of these tools and practical examples of how these tools can be used in a given radiotherapy clinic to develop a risk based quality management program.Learning Objectives: Learn how to design a process map for a radiotherapy process Learn how to perform failure modes and effects analysis analysis for a given process Learn what fault trees are all about Learn how to design a quality management program based upon the information obtained from process mapping, failure modes and effects analysis and fault tree analysis. Dunscombe: Director, TreatSafely, LLC and Center for the Assessment of Radiological Sciences; Consultant to IAEA and VarianThomadsen: President, Center for the Assessment of Radiological SciencesPalta: Vice President of the Center for the Assessment of Radiological Sciences

TU‐AB‐BRD‐00: Task Group 100

Current quality assurance and quality management guidelines provided by various professional organizations are prescriptive in nature, focusing principally on performance characteristics of planning and delivery devices. However, published analyses of events in radiation therapy show that most events are often caused by flaws in clinical processes rather than by device failures. This suggests the need for the development of a quality management program that is based on integrated approaches to process and equipment quality assurance. Industrial engineers have developed various risk assessment tools that are used to identify and eliminate potential failures from a system or a process before a failure impacts a customer. These tools include, but are not limited to, process mapping, failure modes and effects analysis, fault tree analysis. Task Group 100 of the American Association of Physicists in Medicine has developed these tools and used them to formulate an example risk‐based quality management program for intensity‐modulated radiotherapy. This is a prospective risk assessment approach that analyzes potential error pathways inherent in a clinical process and then ranks them according to relative risk, typically before implementation, followed by the design of a new process or modification of the existing process. Appropriate controls are then put in place to ensure that failures are less likely to occur and, if they do, they will more likely be detected before they propagate through the process, compromising treatment outcome and causing harm to the patient. Such a prospective approach forms the basis of the work of Task Group 100 that has recently been approved by the AAPM. This session will be devoted to a discussion of these tools and practical examples of how these tools can be used in a given radiotherapy clinic to develop a risk based quality management program.Learning Objectives: Learn how to design a process map for a radiotherapy process Learn how to perform failure modes and effects analysis analysis for a given process Learn what fault trees are all about Learn how to design a quality management program based upon the information obtained from process mapping, failure modes and effects analysis and fault tree analysis. Dunscombe: Director, TreatSafely, LLC and Center for the Assessment of Radiological Sciences; Consultant to IAEA and VarianThomadsen: President, Center for the Assessment of Radiological SciencesPalta: Vice President of the Center for the Assessment of Radiological Sciences

Expanding patient access to quality medication-related information: the potential of medication hotlines to improve patient adherence in schizophrenia.

Medication nonadherence is a widespread problem that compromises treatment outcomes, particularly in schizophrenia. Weersink et al. (Soc Psychiatry Psychiatr Epidemiol, 2015) describe telephone calls to a national medicines information line, with a focus on queries related to antipsychotic medications. Their analysis of callers' questions and concerns offers a valuable window into patient and caregiver perspectives. Given that many callers reported that they had not shared these concerns with a health care provider, this study also highlights the capacity of medication hotlines to address unmet needs. Establishing and maintaining long-term treatment regimens is a complex task, and truly patient-centered care requires a variety of creative and accessible support resources. Medication lines have the potential to serve as a resource and to provide proactive and timely adherence support.

Prescriptive analytics applied to brace treatment for AIS: a pilot demonstration.

BackgroundPrescriptive analytics is a concept combining statistical and computer sciences to prescribe an optimal course of action, based on predictions of possible future events. In this simulation study we investigate using prescriptive analytics to recommend optimal in-brace corrections for braced Adolescent Idiopathic Scoliosis (AIS) patients. The objectives were to estimate the efficacy of these recommendations, ultimately working toward improved brace design protocols.MethodsData was obtained for 90 AIS patients who had finished brace treatment at our center (60 full-time and 30 nighttime braces). Rates of ≥6 degree progression were 53% for daytime and 30% for nighttime braces. A modeling technique previously developed by our group was used to predict these patients’ likely treatment outcomes given a range of in-brace corrections – the model was blinded to the true outcomes during this process. Each patient’s ‘recommended’ correction was identified as the least aggressive correction resulting in a desirable predicted outcome.The efficacy of these recommendations was estimated using a technique called “clinical trial simulation” (CTS). This technique used a statistical model to predict progression rate under the model-recommended treatment, and compared it to the true progression rate, observed retrospectively, under the actual treatment. Significance was calculated using a permutation test.ResultsModel-recommended corrections ranged from 20%-58% for daytime and 65%-130% for nighttime braces, roughly corresponding with previous literature. Interestingly, in 37% of cases the recommended correction was less than that which had actually been applied, suggesting some opportunity for less aggressive (more comfortable) braces without compromising treatment outcome.The CTS estimated 26% fewer progressive cases using the model-recommended in-brace correction, over the actual correction observed retrospectively in the charts (p=0.05). The patients whose correction decreased under the model’s recommendation did not show an increased progression rate.ConclusionsOptimal correction may be less than the maximum achievable correction. The preliminary results suggest that considering model-generated recommendations during brace fitting could improve outcomes. Future work will expand the system to recommend wear-times as well as corrections, improving its clinical relevance. We envision this pilot demonstration to promote development of model-based decision support in scoliosis treatment, and prompt discussion on its future role.