Diversity, Equity, and Inclusion in Clinical Research: A Path Toward Precision Health for Everyone.

Healthcare disparities are a persistent societal problem. One of the contributing factors to this status quo is the lack of diversity and representativeness of research efforts, which result in nongeneralizable evidence that, in turn, provides suboptimal means to enable the best possible outcomes at the individual level. There are several strategies that research teams can adopt to improve the diversity, equity, and inclusion (DEI) of their efforts; these strategies span the totality of the research path, from initial design to the shepherding of clinical data through a potential regulatory process. These strategies include more intentionality and DEI-based goal-setting, more diverse research and leadership teams, better community engagement to set study goals and approaches, better tailored outreach interventions, decentralization of study procedures and incorporation of innovative technology for more flexible data collection, and self-surveillance to identify and prevent biases. Within their remit of overlooking research efforts, regulatory authorities, as stakeholders, also have the potential for a positive effect on the DEI of emerging clinical evidence. All these are implementable tools and mechanisms that can make study participation more approachable to diverse communities, and ultimately generate evidence that is more generalizable and a conduit for better outcomes. The research community has an imperative to make DEI principles key foundational aspects in study conduct in order to pursue better personalized medicine for diverse patient populations.

Development and Validation of a High-Quality Composite Real-World Mortality Endpoint.

OBJECTIVE: To create a high-quality electronic health record (EHR)-derived mortality dataset for retrospective and prospective real-world evidence generation. DATA SOURCES/STUDY SETTING: Oncology EHR data, supplemented with external commercial and US Social Security Death Index data, benchmarked to the National Death Index (NDI). STUDY DESIGN: We developed a recent, linkable, high-quality mortality variable amalgamated from multiple data sources to supplement EHR data, benchmarked against the highest completeness U.S. mortality data, the NDI. Data quality of the mortality variable version 2.0 is reported here. PRINCIPAL FINDINGS: For advanced non-small-cell lung cancer, sensitivity of mortality information improved from 66 percent in EHR structured data to 91 percent in the composite dataset, with high date agreement compared to the NDI. For advanced melanoma, metastatic colorectal cancer, and metastatic breast cancer, sensitivity of the final variable was 85 to 88 percent. Kaplan-Meier survival analyses showed that improving mortality data completeness minimized overestimation of survival relative to NDI-based estimates. CONCLUSIONS: For EHR-derived data to yield reliable real-world evidence, it needs to be of known and sufficiently high quality. Considering the impact of mortality data completeness on survival endpoints, we highlight the importance of data quality assessment and advocate benchmarking to the NDI.

Actigraphy assessment of sleep quality among patients with acute myeloid leukaemia during induction chemotherapy.

OBJECTIVES: Patients receiving induction chemotherapy for acute myeloid leukaemia (AML) anecdotally describe poor sleep, but sleep disturbances have not been well-characterised in this population. We aimed to test the feasibility of measuring sleep quality in AML inpatients using a wearable actigraphy device. METHODS: Using the Actigraph GT3X 'watch', we assessed the total sleep time, sleep onset latency, wake after sleep onset, number of awakenings after sleep onset and sleep efficiency for inpatients with AML receiving induction chemotherapy. We assessed patient self-reported sleep quality using the Pittsburgh Sleep Quality Index (PSQI). RESULTS: Of the 12 patients enrolled, 11 completed all actigraphy and PSQI assessments, demonstrating feasibility. Patients wore the Actigraph device for a mean (SD) of 15.92 (8.3) days, and actigraphy measures suggested poor sleep. Patients had a median average awakening length of 6.92 min, a median number of awakenings after sleep onset of 4 and a median sleep onset latency of 10.8 min. Actual median sleep efficiency (0.91) was high, suggesting that patients' poor sleep was not due to insomnia but perhaps due to interruptions, such as administration of medications, lab draws and vital sign measurements. CONCLUSIONS: Collection of sleep quality data among inpatients with AML via a wearable actigraphy device is feasible. AML inpatients appear to have poor sleep quality and quantity, suggesting that sleep issues represent an area of unmet supportive care needs in AML. Further research in this areas is needed to inform the development of interventions to improve sleep duration and quality in hospitalised patients with AML.

Optimizing delivery of a behavioral pain intervention in cancer patients using a sequential multiple assignment randomized trial SMART.

BACKGROUND/AIMS: Pain is common in cancer patients and results in lower quality of life, depression, poor physical functioning, financial difficulty, and decreased survival time. Behavioral pain interventions are effective and nonpharmacologic. Traditional randomized controlled trials (RCT) test interventions of fixed time and dose, which poorly represent successive treatment decisions in clinical practice. We utilize a novel approach to conduct a RCT, the sequential multiple assignment randomized trial (SMART) design, to provide comparative evidence of: 1) response to differing initial doses of a pain coping skills training (PCST) intervention and 2) intervention dose sequences adjusted based on patient response. We also examine: 3) participant characteristics moderating intervention responses and 4) cost-effectiveness and practicality. METHODS/DESIGN: Breast cancer patients (N=327) having pain (ratings≥5) are recruited and randomly assigned to: 1) PCST-Full or 2) PCST-Brief. PCST-Full consists of 5 PCST sessions. PCST-Brief consists of one 60-min PCST session. Five weeks post-randomization, participants re-rate their pain and are re-randomized, based on intervention response, to receive additional PCST sessions, maintenance calls, or no further intervention. Participants complete measures of pain intensity, interference and catastrophizing. CONCLUSIONS: Novel RCT designs may provide information that can be used to optimize behavioral pain interventions to be adaptive, better meet patients' needs, reduce barriers, and match with clinical practice. This is one of the first trials to use a novel design to evaluate symptom management in cancer patients and in chronic illness; if successful, it could serve as a model for future work with a wide range of chronic illnesses.

An expanded portfolio of survival metrics for assessing anticancer agents.

OBJECTIVES: With the introduction of more effective anticancer agents that prolong survival, there is a need for new methods to define the clinical value of treatments. The objective of this preliminary qualitative and quantitative analysis was to assess the utility of an expanded portfolio of survival metrics to differentiate the value of anticancer agents. STUDY DESIGN: A literature review was conducted of phase 3 trial data, reported in regulatory submissions within the last 10 years of agents for 6 metastatic cancers (breast cancer, colorectal cancer [CRC], melanoma, non-small cell lung cancer [NSCLC], prostate cancer [PC], and renal cell cancer [RCC]). METHODS: A new, simplified cost-value analysis tool was applied using survival outcomes and total drug costs. Metrics included median overall survival (OS), mean OS, 1-year survival rate, and number needed to treat (NNT) to avoid 1 death at 1 year. Survival results were compiled and compared both within and across trials by tumor type. Total drug costs were calculated by multiplying each agent's cost per month (from October/November 2013, based on the database Price Rx/Medi-Span) by duration of therapy. RESULTS: Relative clinical value for each agent was not consistent across survival outcomes. In 3 tumor types, both the highest improvement in median OS and the highest improvement in mean OS occurred with the same anticancer agent (ipilimumab with melanoma, pemetrexed with NSCLC, and sunitinib with RCC); the highest improvement in the 1-year survival rate and the lowest NNT occurred together with the same anticancer agent in 5 tumor types (bevacizumab with CRC, ipilimumab with melanoma, erlotinib with NSCLC, abiraterone with PC, and temsirolimus with RCC). In the cost-value analysis, agents were inconsistent and achieved a high relative value with some survival outcomes, but not others. CONCLUSIONS: This analysis suggests that any 1 metric may not completely characterize the expected survival benefit of all patients. The cost-value analysis tool may be applied to trial data and may be useful in helping to make treatment decisions, regardless of the agent's effectiveness. A combined metric will be needed, as well as further research that includes more mature data, other tumor types, and emerging treatments.

Study protocol: a phase III randomised, double-blind, parallel arm, stratified, block randomised, placebo-controlled trial investigating the clinical effect and cost-effectiveness of sertraline for the palliative relief of breathlessness in people with chronic breathlessness.

INTRODUCTION: Breathlessness remains a highly prevalent and distressing symptom for many patients with progressive life-limiting illnesses. Evidence-based interventions for chronic breathlessness are limited, and there is an ongoing need for high-quality research into developing management strategies for optimal palliation of this complex symptom. Previous studies have suggested that selective serotonin reuptake inhibitors such as sertraline may have a role in reducing breathlessness. This paper presents the protocol for a large, adequately powered randomised study evaluating the use of sertraline for chronic breathlessness in people with progressive life-limiting illnesses. METHODS AND ANALYSIS: A total of 240 participants with modified Medical Research Council Dyspnoea Scale breathlessness of level 2 or higher will be randomised to receive either sertraline or placebo for 28 days in this multisite, double-blind study. The dose will be titrated up every 3 days to a maximum of 100 mg daily. The primary outcome will be to compare the efficacy of sertraline with placebo in relieving the intensity of worst breathlessness as assessed by a 0-100 mm Visual Analogue Scale. A number of other outcome measures and descriptors of breathlessness as well as caregiver assessments will also be recorded to ensure adequate analysis of participant breathlessness and to allow an economic analysis to be performed. Participants will also be given the option of continuing blinded treatment until either study data collection is complete or net benefit ceases. Appropriate statistical analysis of primary and secondary outcomes will be used to describe the wealth of data obtained. ETHICS AND DISSEMINATION: Ethics approval was obtained at all participating sites. Results of the study will be submitted for publication in peer-reviewed journals and the key findings presented at national and international conferences. TRIAL REGISTRATION NUMBER: ACTRN12610000464066.

Development of the Quality Data Collection Tool for Prospective Quality Assessment and Reporting in Palliative Care.

BACKGROUND: Assessing and reporting the quality of care provided are increasingly important in palliative care, but we currently lack practical, efficient approaches for collection and reporting. OBJECTIVE: In response, the Global Palliative Care Quality Alliance ("Alliance") sought to create a Quality Data Collection Tool for Palliative Care (QDACT-PC). METHODS: We collaboratively and iteratively developed QDACT-PC, an electronic, point-of-care quality monitoring system for palliative care that supports prospective quality assessment and reporting in any clinical setting. QDACT-PC is the web-based data collection and reporting interface. Quality measures selected to be used in QDACT-PC were derived from a systematic review summarizing all published palliative care quality measure sets; Alliance clinical providers prioritized measures to be included in QDACT-PC to ensure maximal clinical relevance. Data elements and variables required to ascertain conformance to all selected quality measures were included in the QDACT-PC data dictionary. Whenever possible, variables collected in QDACT-PC align with validated surveys and/or nationally recognized common data elements. QDACT-PC data elements and software programmed business rules inform real-time assessments of conformance to selected quality measures. Data are deposited into a centralized registry for future analyses. RESULTS: QDACT-PC can be used to report on >80% of all published palliative care quality measures and 100% of high-priority measure. CONCLUSION: Electronic methods for collecting point-of-care quality monitoring data can be developed using collaborative partnerships between community and academic palliative care providers. Feasibility testing and creation of feedback reports are ongoing.

Identifying cancer patients who alter care or lifestyle due to treatment-related financial distress.

BACKGROUND: Cancer patients may experience financial distress as a side effect of their care. Little is known about which patients are at greatest risk for altering their care or lifestyle due to treatment-related financial distress. METHODS: We conducted a cross-sectional survey study to determine which patients are at greatest risk for altering their care or lifestyle due to treatment-related financial distress. Eligible patients were adults receiving cancer treatment enrolled between June 2010 and May 2011. We grouped coping strategies as lifestyle altering or care altering. We assessed coping strategies and relationships between covariates using descriptive statistics and analysis of variance. RESULTS: Among 174 participants, 89% used at least one lifestyle-altering coping strategy, while 39% used a care-altering strategy. Care-altering coping strategies adopted by patients included the following: not filling a prescription (28%) and taking less medication than prescribed (23%). Lifestyle-altering strategies included the following: spending less on leisure activities (77%), spending less on basics like food and clothing (57%), borrowing money (54%), and spending savings (50%). Younger patients were more likely than older patients to use coping strategies (p < 0.001). Lower-income patients adopted care-altering strategies more than higher-income patients (p = 0.03). Participants with more education and shorter duration of chemotherapy used lifestyle-altering strategies more than their counterparts (both p < 0.05). CONCLUSIONS: As a means of coping with treatment-related financial distress, patients were more likely to use lifestyle-altering approaches, but more than one-third adopted potentially harmful care-altering strategies. Younger age, lower income, higher education, and shorter duration of chemotherapy were characteristics associated with greater use of coping strategies. Copyright © 2015 John Wiley & Sons, Ltd.

Characterizing the Hospice and Palliative Care Workforce in the U.S.: Clinician Demographics and Professional Responsibilities.

CONTEXT: Palliative care services are growing at an unprecedented pace. Yet, the characteristics of the clinician population who deliver these services are not known. Information on the roles, motivations, and future plans of the clinician workforce would allow for planning to sustain and grow the field. OBJECTIVES: To better understand the characteristics of clinicians within the field of hospice and palliative care. METHODS: From June through December 2013, we conducted an electronic survey of American Academy of Hospice and Palliative Medicine members. We queried information on demographics, professional roles and responsibilities, motivations for entering the field, and future plans. We compared palliative care and hospice populations alongside clinician roles using chi-square analyses. Multivariable logistic regression was used to identify predictors of leaving the field early. RESULTS: A total of 1365 persons, representing a 30% response rate, participated. Our survey findings revealed a current palliative care clinician workforce that is older, predominantly female, and generally with less than 10 years clinical experience in the field. Most clinicians have both clinical hospice and palliative care responsibilities. Many cite personal or professional growth or influential experiences during training or practice as motivations to enter the field. CONCLUSION: Palliative care clinicians are a heterogeneous group. We identified motivations for entering the field that can be leveraged to sustain and grow the workforce.

The utility of cost discussions between patients with cancer and oncologists.

OBJECTIVES: Patients with cancer can experience substantial financial burden. Little is known about patients' preferences for incorporating cost discussions into treatment decision making or about the ramifications of those discussions. The objective of this study was to determine patient preferences for and benefits of discussing costs with doctors. STUDY DESIGN: Cross-sectional, survey study. METHODS: We enrolled insured adults with solid tumors on anticancer therapy who were treated at a referral cancer center or an affiliated rural cancer clinic. Patients were surveyed at enrollment and again 3 months later about cost discussions with doctors, decision making, and financial burden. Medical records were abstracted for disease and treatment data. Logistic regression investigated characteristics associated with greater desire to discuss costs. RESULTS: Of 300 patients (86% response rate), 52% expressed some desire to discuss treatment-related out-of-pocket costs with doctors and 51% wanted their doctor to take costs into account to some degree when making treatment decisions. However, only 19% had talked to their doctor about costs. Of those, 57% reported lower out-of-pocket costs as a result of cost discussions. In multivariable logistic regression, higher subjective financial distress was associated with greater likelihood to desire cost discussions (odds ratio [OR], 1.22; 95% CI, 1.10-1.36). Nonwhite race was associated with lower likelihood to desire cost discussions (OR, 0.53; 95% CI, 0.30-0.95). CONCLUSIONS: Patients with cancer varied in their desire to discuss costs with doctors, but most who discussed costs believed the conversations helped reduce their expenses. Patient-physician cost communication might reduce out-of-pocket costs even in oncology where treatment options are limited.

Practical Dyspnea Assessment: Relationship Between the 0-10 Numerical Rating Scale and the Four-Level Categorical Verbal Descriptor Scale of Dyspnea Intensity.

CONTEXT: Measurement of dyspnea is important for clinical care and research. OBJECTIVES: To characterize the relationship between the 0-10 Numerical Rating Scale (NRS) and four-level categorical Verbal Descriptor Scale (VDS) for dyspnea assessment. METHODS: This was a substudy of a double-blind randomized controlled trial comparing palliative oxygen to room air for relief of refractory breathlessness in patients with life-limiting illness. Dyspnea was assessed with both a 0-10 NRS and a four-level categorical VDS over the one-week trial. NRS and VDS responses were analyzed in cross section and longitudinally. Relationships between NRS and VDS responses were portrayed using descriptive statistics and visual representations. RESULTS: Two hundred twenty-six participants contributed responses. At baseline, mild and moderate levels of breathlessness were reported by 41.9% and 44.6% of participants, respectively. NRS scores demonstrated increasing mean and median levels for increasing VDS intensity, from a mean (SD) of 0.6 (±1.04) for VDS none category to 8.2 (1.4) for VDS severe category. The Spearman correlation coefficient was strong at 0.78 (P < 0.0001). Based on the distribution of NRS scores within VDS categories, we calculated test characteristics of two different cutpoint models. Both models yielded 75% correct translations from NRS to VDS; however, Model A was more sensitive for moderate or greater dyspnea, with fewer misses downcoded. CONCLUSION: There is strong correlation between VDS and NRS measures for dyspnea. Proposed practical cutpoints for the relationship between the dyspnea VDS and NRS are 0 for none, 1-4 for mild, 5-8 for moderate, and 9-10 for severe.

Validation and real-world assessment of the Functional Assessment of Anorexia-Cachexia Therapy (FAACT) scale in patients with advanced non-small cell lung cancer and the cancer anorexia-cachexia syndrome (CACS).

PURPOSE: Patients with cancer anorexia-cachexia syndrome (CACS) suffer a significant symptom burden, impaired quality of life (QoL), and shorter survival. Measurement of QoL impairments related to CACS is thereby important both in clinical practice and in research. We aimed to further validate the Functional Assessment of Anorexia-Cachexia Therapy (FAACT) scale in an advanced lung cancer population. METHODS: We tested the performance of the FAACT and its anorexia-cachexia subscale (ACS) within a dataset of patients with advanced non-small cell lung cancer (aNSCLC), using standard statistical methods. We then compared the performance of commonly used QoL measures stratified by CACS status and by patient self-report of appetite and weight loss. RESULTS: The FAACT and its ACS demonstrate internal validity consistent with acceptable published ranges for other QoL scales (Cronbach alpha = 0.9 and 0.79, respectively). Correlation coefficients demonstrate moderate correlations in the expected directions between FAACT and ACS and scales that measure related constructs. Comparing patients with and without CACS, the ACS is more sensitive to change than other QoL instruments (mean score 33.1 vs. 37.2, p = 0.011, ES = 0.58). CONCLUSION: In patients with aNSCLC, the FAACT and its ACS performed well compared with other instruments, further supporting their validity and value in clinical research. FAACT and ACS scores covaried with symptoms and other QoL changes that are typical hallmarks of CACS, lending further support to their use as QoL endpoints in clinical trials among patients with CACS.

A population-based cross-sectional study that defined normative population data for the Life-Space Mobility Assessment-composite score.

CONTEXT: Mobility is linked to health status and quality of life. Life-Space Mobility Assessment (LSMA; range 0-120) measures the spatial extent of people's excursion and physical support needs over the preceding month. OBJECTIVES: The aim of this study was to generate normative population data for an LSMA-Composite (LSMA-C) score, irrespective of age or health service contact and explore the LSM of people with diabetes, current asthma, arthritis, and osteoporosis. METHODS: LSMA questions were included in the 2011 South Australian Health Omnibus Survey, a multistage, systematic, and clustered sample of household face-to-face interviews. Sociodemographic and clinical variables were explored in relation to LSMA scores using descriptive, univariable, and multivariable analyses and receiver operator curves. RESULTS: For the 3032 respondents, the mean LSMA score was 98.3 (SD 20.3; median 100; interquartile range 34 [86-120]; range 6-120). Five percent of respondents scored <60, 11% scored between ≥ 60 and 79, 27% scored between ≥ 80 and 99, and the remainder scored between 100 and 120. After 55 years of age, LSMA-C scores declined, more so in females. In multivariable analysis, declining scores were associated with being female, being older, living in rural areas, lower educational attainment, not working, lower household income, and higher numbers of chronic conditions (R(2) = 0.35, P < 0.001). The receiver operator curve demonstrated a highly specific but relatively insensitive measure. CONCLUSION: Having controlled for known confounders, the male/female difference cannot be easily explained. These data will help to contextualize studies in the future that use the LSMA-C score.

The quality imperative for palliative care.

Palliative medicine must prioritize the routine assessment of the quality of clinical care we provide. This includes regular assessment, analysis, and reporting of data on quality. Assessment of quality informs opportunities for improvement and demonstrates to our peers and ourselves the value of our efforts. In fact, continuous messaging of the value of palliative care services is needed to sustain our discipline; this requires regularly evaluating the quality of our care. As the reimbursement mechanisms for health care in the U.S. shift from fee-for-service to fee-for-value models, palliative care will be expected to report robust data on quality of care. We must move beyond demonstrating to our constituents (including patients and referrers), "here is what we do," and increase the focus on "this is how well we do it" and "let us see how we can do it better." It is incumbent on palliative care professionals to lead these efforts. This involves developing standardized methods to collect data without adding additional burden, comparing and sharing our experiences to promote discipline-wide quality assessment and improvement initiatives, and demonstrating our intentions for quality improvement on the clinical frontline.

Setting the vision: applied patient-reported outcomes and smart, connected digital healthcare systems to improve patient-centered outcomes prediction in critical illness.

PURPOSE OF REVIEW: Prediction models in critical illness are generally limited to short-term mortality and uncommonly include patient-centered outcomes. Current outcome prediction tools are also insensitive to individual context or evolution in healthcare practice, potentially limiting their value over time. Improved prognostication of patient-centered outcomes in critical illness could enhance decision-making quality in the ICU. RECENT FINDINGS: Patient-reported outcomes have emerged as precise methodological measures of patient-centered variables and have been successfully employed using diverse platforms and technologies, enhancing the value of research in critical illness survivorship and in direct patient care. The learning health system is an emerging ideal characterized by integration of multiple data sources into a smart and interconnected health information technology infrastructure with the goal of rapidly optimizing patient care. We propose a vision of a smart, interconnected learning health system with integrated electronic patient-reported outcomes to optimize patient-centered care, including critical care outcome prediction. SUMMARY: A learning health system infrastructure integrating electronic patient-reported outcomes may aid in the management of critical illness-associated conditions and yield tools to improve prognostication of patient-centered outcomes in critical illness.

There is a mismatch between the medicare benefit package and the preferences of patients with cancer and their caregivers.

PURPOSE: To identify insured services that are most important to Medicare beneficiaries with cancer and their family caregivers when coverage is limited. METHODS: A total of 440 participants (patients, n = 246; caregivers, n = 194) were enrolled onto the CHAT (Choosing Health Plans All Together) study from August 2010 to March 2013. The exercise elicited preferences about what benefits Medicare should cover for patients with cancer in their last 6 months of life. Facilitated sessions lasted 2.5 hours, included 8 to 10 participants, and focused on choices about Medicare health benefits within the context of a resource-constrained environment. RESULTS: Six of 15 benefit categories were selected by > 80% of participants: cancer care, prescription drugs, primary care, home care, palliative care, and nursing home coverage. Only 12% of participants chose the maximum level of cancer benefits, a level of care commonly financed in the Medicare program. Between 40% and 50% of participants chose benefits not currently covered by Medicare: unrestricted cash, concurrent palliative care, and home-based long-term care. Nearly one in five participants picked some level of each of these three benefit categories and allocated on average 30% of their resources toward them. CONCLUSION: The mismatch between covered benefits and participant preferences shows that addressing quality of life and the financial burden of care is a priority for a substantial subset of patients with cancer in the Medicare program. Patient and caregiver preferences can be elicited, and the choices they express could suggest potential for Medicare benefit package reform and flexibility.

A decision exercise to engage cancer patients and families in deliberation about Medicare coverage for advanced cancer care.

BACKGROUND: Concerns about unsustainable costs in the US Medicare program loom as the number of retirees increase and experiences serious and costly illnesses like cancer. Engagement of stakeholders, particularly cancer patients and their families, in prioritizing insured services offers a valuable strategy for informing Medicare coverage policy. We designed and evaluated a decision exercise that allowed cancer patients and family members to choose Medicare benefits for advanced cancer patients. METHODS: The decision tool, Choosing Health plans All Together (CHAT) was modified to select services for advanced cancer patients. Patients with a cancer history (N = 246) and their family members (N = 194) from North Carolina participated in 70 CHAT sessions. Variables including participants' socio-demographic characteristics, health status, assessments of the exercise and results of group benefit selections were collected. Routine descriptive statistics summarized participant characteristics and Fisher's exact test compared group differences. Qualitative analysis of group discussions were used to ascertain reasons for or against selecting benefits. RESULTS: Patients and family members (N = 440) participated in 70 CHAT exercises. Many groups opted for such services as palliative care, nursing facilities, and services not currently covered by the Medicare program. In choosing among four levels of cancer treatment coverage, no groups chose basic coverage, 27 groups (39%) selected intermediate coverage, 39 groups (56%) selected high coverage, and 4 groups (6%) chose the most comprehensive cancer coverage. Reasons for or against benefit selection included fairness, necessity, need for prioritizing, personal experience, attention to family needs, holistic health outlook, preference for comfort, freedom of choice, and beliefs about the proper role of government. Participants found the exercise very easy (59%) or fairly easy (39%) to understand and very informative (66%) or fairly informative (31%). The majority agreed that the CHAT exercise led to fair decisions about priorities for coverage by which they could abide. CONCLUSIONS: It is possible to involve cancer patients and families in explicit discussions of their priorities for affordable advanced cancer care through the use of decision tools designed for this purpose. A key question is whether such a conversation is possible on a broader, national level.

A universal decision support system. Addressing the decision-making needs of patients, families, and clinicians in the setting of critical illness.

In the setting of a complex critical illness, preference-sensitive decision making-choosing between two or more reasonable treatment options-can be difficult for patients, families, and clinicians alike. A common challenge to making high-quality decisions in this setting is a lack of critical information access and sharing among participants. Decision aids-brochures, web applications, and videos-are a major focus of current research because mounting evidence suggests they can improve decision-making quality and enhance collaborative shared decision making. However, many decision aids have important limitations, including a relatively narrow capacity for personalization, an inability to gather and generate clinical data, a focus on only a single disease or treatment, and high developmental costs. To address these issues and to help guide future research, we propose a model of "universal" electronic decision support that can be easily adapted by clinicians and patients/families for whatever decision is at hand. In this scalable web-based platform, a general shared decision-making core structure would accommodate simple, interchangeable disease and treatment information modules. The format and content of the system could be adapted to decisional participants' unique characteristics, abilities, and needs. Universal decision support can better standardize a decisional approach and also allow a unique degree of personalization within a framework of shared decision making. We also discuss potential criticisms of this approach as well as strategies that can overcome them in a critical illness setting.

Patient-oncologist cost communication, financial distress, and medication adherence.

BACKGROUND: Little is known about the association between patient-oncologist discussion of cancer treatment out-of-pocket (OOP) cost and medication adherence, a critical component of quality cancer care. METHODS: We surveyed insured adults receiving anticancer therapy. Patients were asked if they had discussed OOP cost with their oncologist. Medication nonadherence was defined as skipping doses or taking less medication than prescribed to make prescriptions last longer, or not filling prescriptions because of cost. Multivariable analysis assessed the association between nonadherence and cost discussions. RESULTS: Among 300 respondents (86% response), 16% (n = 49) reported high or overwhelming financial distress. Nineteen percent (n = 56) reported talking to their oncologist about cost. Twenty-seven percent (n = 77) reported medication nonadherence. To make a prescription last longer, 14% (n = 42) skipped medication doses, and 11% (n = 33) took less medication than prescribed; 22% (n = 66) did not fill a prescription because of cost. Five percent (n = 14) reported chemotherapy nonadherence. To make a prescription last longer, 1% (n = 3) skipped chemotherapy doses, and 2% (n = 5) took less chemotherapy; 3% (n = 10) did not fill a chemotherapy prescription because of cost. In adjusted analyses, cost discussion (odds ratio [OR] = 2.58; 95% CI, 1.14 to 5.85; P = .02), financial distress (OR = 1.64, 95% CI, 1.38 to 1.96; P < .001) and higher financial burden than expected (OR = 2.89; 95% CI, 1.41 to 5.89; P < .01) were associated with increased odds of nonadherence. CONCLUSION: Patient-oncologist cost communication and financial distress were associated with medication nonadherence, suggesting that cost discussions are important for patients forced to make cost-related behavior alterations. Future research should examine the timing, content, and quality of cost-discussions.