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Background: Although systems strategies are effective in improving health care delivery, little is known about their use for cancer screening in U.S. primary care practice.Methods: We assessed primary care physicians' (N = 2,475) use of systems strategies for breast, cervical, and colorectal cancer (CRC) screening in a national survey conducted in 2007. Systems strategies included patient and physician screening reminders, performance reports of screening rates, electronic medical records, implementation of in-practice guidelines, and use of nurse practitioners/physician assistants. We evaluated use of both patient and physician screening reminders with other strategies in separate models by screening type, adjusted for the effects of physician and practice characteristics with multivariate logistic regression.Results: Fewer than 10% of physicians used a comprehensive set of systems strategies to support cancer screening; use was greater for mammography and Pap testing than for CRC screening. In adjusted analyses, performance reports of cancer screening rates, medical record type, and in-practice guidelines were associated with use of both patient and physician screening reminders for mammography, Pap testing, and CRC screening (P < 0.05).Conclusion: Despite evidence supporting use of systems strategies in primary care, few physicians report using a comprehensive set of strategies to support cancer screening.Impact: Current health policy initiatives underscore the importance of increased implementation of systems strategies in primary care to improve the use and quality of cancer screening in the United States. Cancer Epidemiol Biomarkers Prev; 20(12); 2471–9. ©2011 AACR.

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Background This Special Issue, Future Directions in Transitional Care Research, focuses on the approaches used and lessons learned by researchers conducting care transitions studies funded by the Patient-Centered Outcomes Research Institute (PCORI). PCORI's approach to transitional care research augments prior research by encouraging researchers to focus on head-to-head comparisons of interventions, the use of patient-centered outcomes, and the engagement of stakeholders throughout the research process. Objectives This paper introduces the themes and topics addressed by the articles that follow, which are focused on opportunities and challenges involved in conducting patient-centered clinical comparative effectiveness research in transitional care. It provides an overview of the state of the care transitions field, a description of PCORI's programmatic objectives, highlights of the patient and stakeholder engagement activities that have taken place during the course of these studies, and a brief overview of PCORI's Transitional Care Evidence to Action Network, a learning community designed to foster collaboration between investigators and their research teams and enhance the collective impact of this body of work. Conclusions The papers in this Special Issue articulate challenges, lessons learned, and new directions for measurement, stakeholder engagement, implementation, and methodological and design approaches that reflect the complexity of transitional care comparative effectiveness research and seek to move the field toward a more holistic understanding of transitional care that integrates social needs and lifespan development into our approaches to improving care transitions.

Hypertension treatment and control prevent more cardiovascular events than management of other modifiable risk factors. Although the age-adjusted proportion of US adults with controlled blood pressure (BP) defined as

Objective The Patient-Centered Outcomes Research Institute (PCORI) uses a unique approach to Merit Review that includes patients and stakeholders as reviewers with scientists, and includes unique review criteria (patient-centeredness and active engagement of end users in the research). This study assessed the extent to which different reviewer types influence review scores and funding outcomes, the emphasis placed on technical merit compared to other criteria by a multistakeholder panel, and the impact of the in-person discussion on agreement among different reviewer types. Methods Cross-sectional analysis of administrative data from PCORI online and in-person Merit Review (N = 1312 applications from the five funding cycles from November 2013 to August 2015). Linear and logistic regression models were used to analyze the data. Results For all reviewer types, final review scores were associated with at least one review criterion score from each of the three reviewer types. The strongest predictor of final overall scores for all reviewer types was scientists’ prediscussion ratings of technical merit. All reviewers’ prediscussion ratings of the potential to improve health care and outcomes, and scientists’ ratings of technical merit and patient-centeredness, were associated with funding success. For each reviewer type, overall impact scores from the online scoring were changed on at least half of the applications at the in-person panel discussion. Score agreement across reviewer types was greater after panel discussion. Conclusions Scientist, patient, and stakeholder views all contribute to PCORI Merit Review of applications for research funding. Technical merit is critical to funding success but patient and stakeholder ratings of other criteria also influence application disposition.

Author(s): Bhasin, Shalender; Gill, Thomas M; Reuben, David B; Latham, Nancy K; Gurwitz, Jerry H; Dykes, Patricia; McMahon, Siobhan; Storer, Thomas W; Duncan, Pamela W; Ganz, David A; Basaria, Shehzad; Miller, Michael E; Travison, Thomas G; Greene, Erich J; Dziura, James; Esserman, Denise; Allore, Heather; Carnie, Martha B; Fagan, Maureen; Hanson, Catherine; Baker, Dorothy; Greenspan, Susan L; Alexander, Neil; Ko, Fred; Siu, Albert L; Volpi, Elena; Wu, Albert W; Rich, Jeremy; Waring, Stephen C; Wallace, Robert; Casteel, Carri; Magaziner, Jay; Charpentier, Peter; Lu, Charles; Araujo, Katy; Rajeevan, Haseena; Margolis, Scott; Eder, Richard; McGloin, Joanne M; Skokos, Eleni; Wiggins, Jocelyn; Garber, Lawrence; Clauser, Steven B; Correa-De-Araujo, Rosaly; Peduzzi, Peter | Abstract: Background:Fall injuries are a major cause of morbidity and mortality among older adults. We describe the design of a pragmatic trial to compare the effectiveness of an evidence-based, patient-centered multifactorial fall injury prevention strategy to an enhanced usual care. Methods:Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) is a 40-month cluster-randomized, parallel-group, superiority, pragmatic trial being conducted at 86 primary care practices in 10 health care systems across United States. The 86 practices were randomized to intervention or control group using covariate-based constrained randomization, stratified by health care system. Participants are community-living persons, ≥70 years, at increased risk for serious fall injuries. The intervention is a comanagement model in which a nurse Falls Care Manager performs multifactorial risk assessments, develops individualized care plans, which include surveillance, follow-up evaluation, and intervention strategies. Control group receives enhanced usual care, with clinicians and patients receiving evidence-based information on falls prevention. Primary outcome is serious fall injuries, operationalized as those leading to medical attention (nonvertebral fractures, joint dislocation, head injury, lacerations, and other major sequelae). Secondary outcomes include all fall injuries, all falls, and well-being (concern for falling; anxiety and depressive symptoms; physical function and disability). Target sample size was 5,322 participants to provide 90% power to detect 20% reduction in primary outcome rate relative to control. Results:Trial enrolled 5,451 subjects in 20 months. Intervention and follow-up are ongoing. Conclusions:The findings of the STRIDE study will have important clinical and policy implications for the prevention of fall injuries in older adults.

According to a landmark study by the Institute of Medicine, patients with cancer often receive poorly coordinated care in multiple settings from many providers. Lack of coordination is associated with poor symptom control, medical errors, and higher costs. The aims of this systematic review and meta-analysis were to (1) synthesize the findings of studies addressing cancer care coordination, (2) describe study outcomes across the cancer continuum, and (3) obtain a quantitative estimate of the effect of interventions in cancer care coordination on service system processes and patient health outcomes. Of 1241 abstracts identified through MEDLINE, EMBASE, CINAHL, and the Cochrane Library, 52 studies met the inclusion criteria. Each study had US or Canadian participants, comparison or control groups, measures, times, samples, and/or interventions. Two researchers independently applied a standardized search strategy, coding scheme, and online coding program to each study. Eleven studies met the additional criteria for the meta-analysis; a random effects estimation model was used for data analysis. Cancer care coordination approaches led to improvements in 81 % of outcomes, including screening, measures of patient experience with care, and quality of end-of-life care. Across the continuum of cancer care, patient navigation was the most frequent care coordination intervention, followed by home telehealth; nurse case management was third in frequency. The meta-analysis of a subset of the reviewed studies showed that the odds of appropriate health care utilization in cancer care coordination interventions were almost twice (OR = 1.9, 95 % CI = 1.5–3.5) that of comparison interventions. This review offers promising findings on the impact of cancer care coordination on increasing value and reducing healthcare costs in the USA.

This study builds on analyses performed as part of an original comprehensive National Cancer Institute Community Cancer Centers Program evaluation and examines improvements in quality of care. The following research questions are addressed: (a) have improvements in concordance rates with the five quality of care measures been sustained since 2010 and (b) how does the change in concordance for minority/underserved patients compare to the change for nonminority/nonunderserved patients through 2013?, Background. The National Cancer Institute Community Cancer Centers Program (NCCCP) pilot was designed to improve quality of cancer care and reduce disparities at community hospitals. The NCCCP's primary intervention was the implementation of the Commission on Cancer Rapid Quality Reporting System (RQRS). The RQRS is a hospital‐based data collection and evaluation system allowing near real‐time assessment of selected breast and colon cancer quality of care measures. Building on previous NCCCP analyses, this study examined whether improvements in quality cancer care within NCCCP hospitals early in the program were sustained and whether improvements were notable for minority or underserved populations. Methods. We compared changes in concordance with three breast and two colon cancer quality measures approved by the National Quality Forum for patients diagnosed at NCCCP hospitals from 2006 to 2007 (pre‐RQRS), 2008 to 2010 (early‐RQRS), and 2011 to 2013 (later‐RQRS). Data were obtained from NCCCP sites participating in the Commission on Cancer Rapid Quality Reporting System. Logistic regression analyses were performed to identify predictors of concordance with breast and colon cancer quality measures. Results. The sample included 13,893 breast and 5,546 colon cancer patients. After RQRS initiation, all five quality measures improved significantly and improvements were sustained through 2013. Quality of care measures showed sustained improvements for both breast and colon cancer patients and for vulnerable patient subgroups including black, uninsured, and Medicaid‐covered patients. Conclusions. Quality improvements in NCCCP hospitals were sustained throughout the duration of the program, both overall and among minority and underserved patients. Because many individuals receive cancer treatment at community hospitals, facilitating high‐quality care in these environments must be a priority. Implications for Practice. Quality improvement programs often improve practice, but the methods are not maintained over time. The implementation of a real‐time quality reporting system and a network focused on improving quality of care sustained quality improvement at select community cancer centers. The NCCCP pilot increased numbers of patients receiving guideline‐concordant care for breast and colon cancer in community settings, and initial improvements noted in earlier years of RQRS were sustained into later years, both overall and among minority and underserved patients. National initiatives that improve care for diverse patient groups are important for reducing and eliminating barriers to care.

Palliative care is a growing specialty that addresses the needs of individuals diagnosed with advanced illness and their caregivers. Although palliative care has been shown to improve a variety of patient- and caregiver-centered outcomes, access to comprehensive palliative care services for patients is often limited. There is a need to identify the most effective approaches to delivering palliative care to patients in community settings. In fiscal year 2017, based on extensive input from a diverse set of stakeholders, the Patient-Centered Outcomes Research Institute (PCORI) funded nine multisite comparative clinical effectiveness research (CER) trials focused on community-based delivery of palliative care for a total investment of $80 million. These studies, focusing on advance care planning and models of palliative care delivery, represent some of the largest most complex palliative care trials funded to date. Each study evaluates both patient and caregiver outcomes, and together, these trials include a broad range of health conditions, interventions, and settings of care. PCORI has also fostered a learning network of the funded awardees to facilitate the successful conduct of these CER studies and to support awardee efforts to develop collaborative products relevant to advancing the field of palliative care research and practice. The protocols of each of the nine trials, detailed in this issue, demonstrate the expansive reach of the investment PCORI has made in an effort to further the research agenda and provide substantive research evidence in stakeholder-identified areas of need in the field of palliative care.

PURPOSE Pain, fatigue, and distress are common among patients with cancer but are often underassessed and undertreated. We examine the prevalence of pain, fatigue, and emotional distress among patients with cancer, as well as patient perceptions of the symptom care they received. PATIENTS AND METHODS Seventeen Commission on Cancer–accredited cancer centers across the United States sampled patients with local/regional breast (82%) or colon (18%) cancer. We received 2,487 completed surveys (61% response rate). RESULTS Of patients, 76%, 78%, and 59% reported talking to a clinician about pain, fatigue, and distress, respectively, and 70%, 61%, and 54% reported receiving advice. Sixty-one percent of patients experienced pain, 74% fatigue, and 46% distress. Among those patients experiencing each symptom, 58% reported getting the help they wanted for pain, 40% for fatigue, and 45% for distress. Multilevel logistic regression models revealed that patients experiencing symptoms were significantly more likely to have talked about and received advice on coping with these symptoms. In addition, patients who were receiving or recently completed curative treatment reported more symptoms and better symptom care than did those who were further in time from curative treatment. CONCLUSION In our sample, 30% to 50% of patients with cancer in community cancer centers did not report discussing, getting advice, or receiving desired help for pain, fatigue, or emotional distress. This finding suggests that there is room for improvement in the management of these three common cancer-related symptoms. Higher proportions of talk and advice among those experiencing symptoms imply that many discussions may be patient initiated. Lower rates of talk and advice among those who are further in time from treatment suggest the need for more assessment among longer-term survivors, many of whom continue to experience these symptoms. These findings seem to be especially important given the high prevalence of these symptoms in our sample.

Background This paper describes a protocol for determining the incidence of serious fall injuries for Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE), a large, multicenter pragmatic clinical trial with limited resources for event adjudication. We describe how administrative data (from participating health systems and Medicare claims) can be used to confirm participant-reported events, with more time- and resource-intensive full-text medical record data used only on an “as-needed” basis. Methods STRIDE is a pragmatic cluster-randomized controlled trial involving 5451 participants age ≥ 70 and at increased risk for falls, served by 86 primary care practices in 10 US health systems. The STRIDE intervention involves a nurse falls care manager who assesses a participant’s underlying risks for falls, suggests interventions using motivational interviewing, and then creates, implements and longitudinally follows up on an individualized care plan with the participant (and caregiver when appropriate), in partnership with the participant’s primary care provider. STRIDE’s primary outcome is serious fall injuries, defined as a fall resulting in: (1) medical attention billable according to Medicare guidelines with a) fracture (excluding isolated thoracic vertebral and/or lumbar vertebral fracture), b) joint dislocation, or c) cut requiring closure; OR (2) overnight hospitalization with a) head injury, b) sprain or strain, c) bruising or swelling, or d) other injury determined to be “serious” (i.e., burn, rhabdomyolysis, or internal injury). Two sources of data are required to confirm a serious fall injury. The primary data source is the participant’s self-report of a fall leading to medical attention, identified during telephone interview every 4 months, with the confirmatory source being (1) administrative data capturing encounters at the participating health systems or Medicare claims and/or (2) the full text of medical records requested only as needed. Discussion Adjudication is ongoing, with over 1000 potentially qualifying events adjudicated to date. Administrative data can be successfully used for adjudication, as part of a hybrid approach that retrieves full-text medical records only when needed. With the continued refinement and availability of administrative data sources, future studies may be able to use administrative data completely in lieu of medical record review to maximize the quality of adjudication with finite resources. Trial registration ClinicalTrials.gov (NCT02475850). Electronic supplementary material The online version of this article (10.1186/s40621-019-0190-2) contains supplementary material, which is available to authorized users.

In 2010, Patient-Centered Outcomes Research Institute (PCORI) was authorized by Congress to improve the quality and relevance of evidence available to help patients, caregivers, employers, insurers, and policy makers make better-informed health decisions. We conducted a qualitative analysis of behavioral health trials in the PCORI Addressing Disparities portfolio to examine cultural tailoring strategies across the following priority populations: racial and ethnic minorities, rural populations, people with low-income or low socioeconomic status, individuals with disabilities, people with low health literacy, and lesbian, gay, bisexual, and transgender (LGBT) communities. The Common Strategies for Enhancing Cultural Appropriateness model was used to examine cultural tailoring strategies within trials. We hypothesized increased intersectionality within a patient population at risk for disparities would correlate with the dosage and type of cultural tailoring strategies applied. Thirty-three behavioral health trials applied cultural tailoring strategies and a majority of trials (n = 30) used three or more strategies. Trends in cultural tailoring were associated with certain racial and ethnic groups, however, increased use of tailoring was not associated with the number of priority populations included in a trial. The PCORI Addressing Disparities portfolio demonstrates how a range of cultural tailoring strategies are used, within comparative clinical effectiveness research trials, to address the needs and intersectionality of patients to reduce health and healthcare disparities.

PURPOSE OF REVIEW: Diabetes incidence is rising among vulnerable population subgroups including minorities and individuals with limited education. Many diabetes-related programs and public policies are unevaluated while others are analyzed with research designs highly susceptible to bias which can result in flawed conclusions. The Natural Experiments for Translation in Diabetes 2.0 (NEXT-D2) Network includes eight research centers and three funding agencies using rigorous methods to evaluate natural experiments in health policy and program delivery. RECENT FINDINGS: NEXT-D2 research studies use quasi-experimental methods to assess three major areas as they relate to diabetes: health insurance expansion; healthcare financing and payment models; and innovations in care coordination. The studies will report on preventive processes, achievement of diabetes care goals, and incidence of complications. Some studies assess healthcare utilization while others focus on patient-reported outcomes. SUMMARY: NEXT-D2 examines the effect of public and private policies on diabetes care and prevention at a critical time, given ongoing and rapid shifts in the US health policy landscape.

A priority for many older adults is to remain in their homes and communities. This paper describes the Patient-Centered Outcomes Research Institute’s (PCORI) review of our investment in comparative effectiveness research (CER) that will advance the field of “aging in place.” To inform our systematic evaluation, we first engaged our multi-stakeholder advisory panel of patients/caregivers, clinicians, health systems leaders, and payers to develop and refine a conceptual framework for research focused on aging in place among older adults. Key themes from stakeholders were: aging in place interventions should be patient-centered and align with the patients’ needs and goals, studies should include individuals 55+ years who may be at risk for institutionalization, relevant interventions go beyond environmental modifications and include social support, healthcare (inclusive of palliative care), and personal care services. In addition, aging in place services should focus more on informal caregiver interventions and outcomes since informal caregivers play a major role in enabling older adults to age in place. We identified 14 PCORI-funded CER projects that will provide evidence on the most effective interventions to promote aging in place among older adults; the total investment is $113.4 million dollars. The portfolio is addressing decisional dilemmas faced by multiple stakeholders on a variety of topics including falls prevention, home-based palliative care, and community-based care models; however, several critical CER evidence gaps remain that need to be addressed in future funding investments and will be discussed during the presentation.

Researchers and clinicians are increasingly recognizing the value of patient-reported outcome (PRO) data to better characterize people's health and experiences with illness and care. Considering the rising prevalence of cancer in adults aged 65 and older, PRO data are particularly relevant for older adults with cancer, who often require complex cancer care and have additional comorbid conditions. A data linkage between the Surveillance Epidemiology and End Results (SEER) cancer registry and the Medicare Health Outcomes Survey (MHOS) was created through a partnership between the National Cancer Institute and the Centers for Medicare and Medicaid Services that created the opportunity to examine PROs in Medicare Advantage enrollees with and without cancer. The December 2013 linkage of SEER-MHOS data included the linked data for 12 cohorts, bringing the number of individuals in the linked data set to 95,723 with cancer and 1,510,127 without. This article reviews the features of the resource and provides information on some descriptive characteristics of the individuals in the data set (health-related quality of life, body mass index, fall risk management, number of unhealthy days in the past month). Individuals without (n=258,108) and with (n=3,440) cancer (1,311 men with prostate cancer, 982 women with breast cancer, 689 with colorectal cancer, 458 with lung cancer) were included in the current descriptive analysis. Given increasing longevity, advances in effective therapies and earlier detection, and population growth, the number of individuals aged 65 and older with cancer is expected to reach more than 12 million by 2020. SEER-MHOS provides population-level, self-reported, cancer registry-linked data for person-centered surveillance research on this growing population.

Patient-reported outcomes (PROs) measure quality of life, symptoms, patient functioning, and patient perceptions of care; they are essential for gaining a full understanding of cancer care and the impact of cancer on people's lives. Repeatedly captured facility-level and/or population-level PROs (PRO surveillance) could play an important role in quality monitoring and improvement, benchmarking, advocacy, policy making, and research. This article describes the rationale for PRO surveillance and the methods of the Patient Reported Outcomes Symptoms and Side Effects Study (PROSSES), which is the first PRO study to use the American College of Surgeons Commission on Cancer's Rapid Quality Reporting System to identify patients and manage study data flow. The American Cancer Society, the National Cancer Institute, the Commission on Cancer, and RTI International collaborated on PROSSES. PROSSES was conducted at 17 cancer programs that participated in the National Cancer Institute Community Cancer Centers Program among patients diagnosed with locoregional breast or colon cancer. The methods piloted in PROSSES were successful as demonstrated by high eligibility (93%) and response (61%) rates. Differences in clinical and demographic characteristics between respondents and nonrespondents were mostly negligible, with the exception that non-white individuals were somewhat less likely to respond. These methods were consistent across cancer centers and reproducible over time. If repeated and expanded, they could provide PRO surveillance data from patients with cancer on a national scale.

Understanding how health care system structures, processes, and available resources facilitate and/or hinder the delivery of quality cancer care is imperative, especially given the rapidly changing health care landscape. The emerging field of cancer care delivery research (CCDR) focuses on how organizational structures and processes, care delivery models, financing and reimbursement, health technologies, and health care provider and patient knowledge, attitudes, and behaviors influence cancer care quality, cost, and access and ultimately the health outcomes and well-being of patients and survivors. In this article, we describe attributes of CCDR, present examples of studies that illustrate those attributes, and discuss the potential impact of CCDR in addressing disparities in care. We conclude by emphasizing the need for collaborative research that links academic and community-based settings and serves simultaneously to accelerate the translation of CCDR results into practice. The National Cancer Institute recently launched its Community Oncology Research Program, which includes a focus on this area of research.

More than a decade after the Institute of Medicine (IOM) first studied the quality of cancer care, obstacles to achieving high-quality care remain, and studies suggest that cancer care is often not as patient centered, accessible, coordinated, or evidence based as it could be. Patients, their families, and clinicians face a wide range of complex and often confusing choices regarding their health and health care concerns and require trustworthy information to decide which options are best for them. The Patient-Centered Outcomes Research Institute (PCORI) strives to fund clinical comparative effectiveness research, guided by patients, caregivers, and the broader health care community, that will provide high-integrity, evidence-based information to help people make informed health care decisions. This mission is well aligned with the IOM's recent conceptual framework and corresponding recommendations that recognize that addressing the needs of patients with cancer and their families is the most important component of a high-quality cancer care delivery system. PCORI seeks the opportunity to partner with diverse interdisciplinary research teams who demonstrate a strong commitment to the inclusion and engagement of patients and stakeholders as they work to develop high-quality cancer care delivery systems. We see rich opportunities for such partnership in the cancer care community, given the wealth of well-established patient advocacy groups and organizations and cutting-edge research institutions, all of which are working toward the common goal of improving the quality of cancer care for patients and their families. This article and the project it describes provide an example of an avenue for advancing this goal.

Background We sought to determine if patient characteristics, including race/ethnicity, were associated with patient-reported care coordination for colorectal cancer (CRC) patients treated in the Veterans Affairs (VA) healthcare system, with the goal of better understanding potential goals of quality improvement efforts aimed at improving coordination.

© 2015 Society of General Internal Medicine BACKGROUND: Since 1990, the National Cancer Institute (NCI) and Centers for Medicare and Medicaid Services (CMS) have collaborated to create linked data resources to improve our understanding of patterns of care, health care costs, and trends in utilization. However, existing data linkages have not included measures of patient experiences with care. OBJECTIVE: To describe a new resource for quality of care research based on a linkage between the Medicare Consumer Assessment of Healthcare Providers and Systems (CAHPS®) patient surveys and the NCI’s Surveillance, Epidemiology and End Results (SEER) data. DESIGN: This is an observational study of CAHPS respondents and includes both fee-for-service and Medicare Advantage beneficiaries with and without cancer. The data linkage includes: CAHPS survey data collected between 1998 and 2010 to assess patient reports on multiple aspects of their care, such as access to needed and timely care, doctor communication, as well as patients’ global ratings of their personal doctor, specialists, overall health care, and their health plan; SEER registry data (1973–2007) on cancer site, stage, treatment, death information, and patient demographics; and longitudinal Medicare claims data (2002–2011) for fee-for-service beneficiaries on utilization and costs of care. PARTICIPANTS: In total, 150,750 respondents were in the cancer cohort and 571,318 were in the non-cancer cohort. MAIN MEASURES: The data linkage includes SEER data on cancer site, stage, treatment, death information, and patient demographics, in addition to longitudinal data from Medicare claims and information on patient experiences from CAHPS surveys. KEY RESULTS: Sizable proportions of cases from common cancers (e.g., breast, colorectal, prostate) and short-term survival cancers (e.g., pancreas) by time since diagnosis enable comparisons across the cancer care trajectory by MA vs. FFS coverage. CONCLUSIONS: SEER-CAHPS is a valuable resource for information about Medicare beneficiaries’ experiences of care across different diagnoses and treatment modalities, and enables comparisons by type of insurance.

Objectives The Patient-Centered Outcomes Research Institute (PCORI) includes patients and stakeholders alongside scientists in reviewing research applications using unique review criteria including patient-centeredness and patient and/or stakeholder engagement. To support extension of this unique collaborative model to other funders, information from the reviewers on the review process is needed to understand how scientists and nonscientists evaluate research proposals together. Thus, this study aimed to describe reviewers' perspectives of the interactions during the in-person review panel; to examine the value and challenges of including scientists, patients, and stakeholders together; and to understand the perceived importance of PCORI's review criteria. Methods This study utilized anonymous, cross-sectional surveys (N = 925 respondents from 5 funding cycles: 470 scientists, 217 patients, 238 stakeholders; survey completion rates by cycle: 70–89%) and group interviews (N = 18). Results Reviewers of all types describe PCORI Merit Review as respectful, balanced, and one of reciprocal influence among different reviewer types. Reviewers indicate strong support and value of input from all reviewer types, receptivity to input from others, and the panel chair's incorporation of all views. Patients and stakeholders provide real-world perspectives on importance to patients, research partnership plans, and study feasibility. Challenges included concerns about a lack of technical expertise of patient/stakeholder reviewers and about scientists dominating conversations. The most important criterion for assigning final review scores was technical merit—either alone or in conjunction with patient-centeredness or patient/ stakeholder engagement. Conclusions PCORI Merit Reviewers' self-reports indicate that the perspectives of different reviewer types are influential in panel discussions and Merit Review outcomes.

© 2014 American Cancer Society. BACKGROUND: Research on health-related quality of life (HRQOL) among older adult cancer survivors is mostly confined to breast cancer, prostate cancer, colorectal cancer, and lung cancer, which account for 63% of all prevalent cancers. Much less is known about HRQOL in the context of less common cancer sites. METHODS: HRQOL was examined with the 36-Item Short Form Health Survey, version 1, and the Veterans RAND 12-Item Health Survey in patients with selected cancers (kidney cancer, bladder cancer, pancreatic cancer, upper gastrointestinal cancer, cancer of the oral cavity and pharynx, uterine cancer, cervical cancer, thyroid cancer, melanoma, chronic leukemia, non-Hodgkin lymphoma, and multiple myeloma) and in individuals without cancer on the basis of data linked from the Surveillance, Epidemiology, and End Results cancer registry system and the Medicare Health Outcomes Survey. Scale scores, Physical Component Summary (PCS) and Mental Component Summary (MCS) scores, and a utility metric (Short Form 6D/Veterans RAND 6D), adjusted for sociodemographic characteristics and other chronic conditions, were calculated. A 3-point difference in the scale scores and a 2-point difference in the PCS and MCS scores were considered to be minimally important differences. RESULTS: Data from 16,095 cancer survivors and 1,224,549 individuals without a history of cancer were included. The results indicated noteworthy deficits in physical health status. Mental health was comparable, although scores for the Role-Emotional and Social Functioning scales were worse for patients with most types of cancer versus those without cancer. Survivors of multiple myeloma and pancreatic malignancies reported the lowest scores, with their PCS/MCS scores less than those of individuals without cancer by 3 or more points. CONCLUSIONS: HRQOL surveillance efforts revealed poor health outcomes among many older adults and specifically among survivors of multiple myeloma and pancreatic cancer.

Genomic technologies are increasing the precision with which clinicians can assess an individual patient's risk for developing diseases and identify which patients are likely to benefit from specific treatments. Also advocating for a shift away from a one-size-fits-all approach is the growing emphasis on "patient-centered" care. Using examples from breast cancer, we make a case for why, in order to optimize patient health outcomes, genomic medicine will need to be practiced within a patient-centered framework. We present a six-function conceptual framework for patient-centered care and discuss findings from a national survey evaluating the patient-centeredness of care delivered in the USA.

A family-centered approach to care is vital, and caregivers play an important role in patient-centered care for older adults. This analysis of the Patient-Centered Outcomes Research Institute’s (PCORI) portfolio of clinical comparative effectiveness research (CER) trials explores the extent to which caregiving for older adults is a focus within our funded studies and examines how these studies incorporate interventions and outcomes related to caregivers. Of 116 studies in the portfolio with a caregiving component, only 35 studies focus on caregivers of older adults. Approximately half of these studies (16) were not focused on a specific disease, but rather included older adults with a variety of diseases. Caregivers were the target of a delivered intervention in 18 studies. Among these studies, all but one included caregivers as part of a multicomponent intervention. The most common intervention components were caregiver training (14 studies) and inclusion of caregivers in the delivery of health services, notably coordination of care (17), home visits (9), integrated care (9), multidisciplinary care teams (9), and clinical decision tools (8). Caregiver-focused outcomes were assessed in 26 studies. The most frequently assessed domains include measures of health and well-being (most commonly psychosocial status; n=20), evaluation of care (most commonly satisfaction; n=8), and health behavior (most commonly attitudes; n=6). In general, given stakeholder interest in family-centered research on older adults, future CER research should include caregivers and/or compare interventions focused solely on the unique needs of caregivers of older adults. Inclusion of caregiver-related outcomes should also be promoted.

PurposeDocumenting the impact of different types of cancer on daily functioning and well-being is important for understanding burden relative to other chronic medical conditions. This study examined the impact of 10 different cancers and 13 other chronic medical conditions on health-related quality of life.MethodsHealth-related quality of life data were gathered on the Medicare Health Outcomes Survey (MHOS) between 1998 and 2002. Cancer information was ascertained using the National Cancer Institute's surveillance, epidemiology, and end results program and linked to MHOS data.ResultsThe average SF-6D score was 0.73 (SD = 0.14). Depressive symptoms had the largest unique association with the SF-6D, followed by arthritis of the hip, chronic obstructive pulmonary disease/asthma, stroke, and sciatica. In addition, the majority of cancer types were significantly associated with the SF-6D score, with significant negative weights ranging from -0.01 to -0.02 on the 0-1 health utility scale. Distant stage of cancer was associated with large decrements in the SF-6D ranging from -0.04 (prostate) to -0.08 (female breast).ConclusionA large number of chronic conditions, including cancer, are associated uniquely with decrements in health utility. The cumulative effects of comorbid conditions have substantial impact on daily functioning and well-being of Medicare beneficiaries.

The National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a library of question items that enables patient reporting of adverse events (AEs) in clinical trials. This study contributes content validity evidence of the PRO-CTCAE by incorporating cancer patient input of the relevance and comprehensiveness of the item library.Cognitive interviews were conducted among patients undergoing chemotherapy or radiation therapy at multiple sites to evaluate comprehension, memory retrieval, judgment, and response mapping related to AE terms (e.g., nausea), attribute terms (regarding frequency, severity, or interference), response options, and recall period. Three interview rounds were conducted with ≥20 patients completing each item per round. Items were modified and retested if ≥3 patients exhibited cognitive difficulties or if experienced by ≤25% patients.One hundred and twenty-seven patients participated (35% ≤high school, 28% non-white, and 59% female). Most AE terms (63/80) generated no cognitive difficulties. The remaining 17 were modified without further difficulties by Round 3. Terms were comprehended regardless of education level. Attribute terms and response options required no modifications. Patient adherence to recall period (7 days) was improved when the reference period was incorporated.This study provides evidence confirming comprehension of the US English language versions of items in the PRO-CTCAE library for measuring symptomatic AEs from the patient perspective within the context of cancer treatment. Several minor changes were made to the items to improve item clarity, comprehension, and ease of response judgment. This study helps to establish the content validity of PRO-CTCAE items for patient reporting of AEs during cancer treatment.

Purpose: Chemotherapy prolongs survival in patients with advanced non–small-cell lung cancer. However, few studies have included patients with poor performance status. This study examined rates of oncologists’ recommendations for chemotherapy by patient performance status and symptoms and how physician characteristics influence chemotherapy recommendations. Methods: We surveyed medical oncologists involved in the care of a population-based cohort of patients with lung cancer from the CanCORS (Cancer Care Outcomes Research and Surveillance) study. Physicians were queried about their likelihood to recommend chemotherapy to patients with stage IV lung cancer with varying performance status (Eastern Cooperative Oncology Group performance status 0 [good] v 3 [poor]) and presence or absence of tumor-related pain. Repeated measures logistic regression was used to estimate the independent associations of patients’ performance status and symptoms and physicians’ demographic and practice characteristics with chemotherapy recommendations. Results: Nearly all physicians (adjusted rate, 97% to 99%) recommended chemotherapy for patients with good performance status, and approximately half (adjusted rate, 38% to 53%) recommended chemotherapy for patients with poor performance status (P < .001). Compared with patient factors, physician and practice characteristics were less strongly associated with chemotherapy recommendations in adjusted analyses. Conclusion: Strong consensus among oncologists exists for chemotherapy in patients with advanced non–small-cell lung cancer and good performance status. However, the relatively high rate of chemotherapy recommendations for patients with poor performance status despite the unfavorable risk–benefit profile highlights the need for ongoing work to define high-value care in oncology and to implement and evaluate strategies to align incentives for such care.

Patient experiences with symptom care need to be assessed and documented to ensure successful management of cancer-related symptoms. This paper details one method for creating symptom management quality improvement (SMQI) reports, including case-mix adjustment of patient-reported measures. Qualitative data regarding the acceptability of these reports at participating cancer centers (CCs) are also provided. Data were collected from 2226 patients treated at 16 CCs via mailed/Web questionnaires. Twelve items assessing patient perceptions of symptom management—pain, fatigue, emotional distress—served as key quality indicators. Medico-demographic variables suitable for case-mix adjustment were selected using an index score combining predictive power and heterogeneity across CCs. SMQI reports were designed with staff feedback and produced for each CC, providing crude and adjusted CC-specific rates, along with study-wide rates for comparison purposes. Cancer type and participant educational level were selected for case-mix adjustment based upon high index scores. The Kendall rank correlation coefficient showed that case-mix adjustments changed the ranking of CCs on the key quality indicators (% Δ rank range: 5–22 %). The key quality indicators varied across CCs (all p

Objective To assess primary care physicians' (PCPs) knowledge of energy balance related guidelines and the association with sociodemographic characteristics and clinical care practices. Method As part of the 2008 U.S. nationally representative National Survey of Energy Balance Related Care among Primary Care Physicians (EB-PCP), 1776 PCPs from four specialties who treated adults ( n = 1060) or children and adolescents ( n = 716) completed surveys on sociodemographic information, knowledge of energy balance guidelines, and clinical care practices. Results EB-PCP response rate was 64.5%. For PCPs treating children, knowledge of guidelines for healthy BMI percentile, physical activity, and fruit and vegetables intake was 36.5%, 27.0%, and 62.9%, respectively. For PCPs treating adults, knowledge of guidelines for overweight, obesity, physical activity, and fruit and vegetables intake was 81.4%, 81.3%, 70.9%, and 63.5%, respectively. Generally, younger, female physicians were more likely to exhibit correct knowledge. Knowledge of weight-related guidelines was associated with assessment of body mass index (BMI) and use of BMI-for-age growth charts. Conclusion Knowledge of energy balance guidelines among PCPs treating children is low, among PCPs treating adults it appeared high for overweight and obesity-related clinical guidelines and moderate for physical activity and diet, and was mostly unrelated to clinical practices among all PCPs.

Health care in the United States is notoriously expensive while often failing to deliver the care recommended in published guidelines. There is, therefore, a need to consider our approach to health-care delivery. Cancer care is a good example for consideration because it spans the continuum of health-care issues from primary prevention through long-term survival and end-of-life care. In this monograph, we emphasize that health-care delivery occurs in a multilevel system that includes organizations, teams, and individuals. To achieve health-care delivery consistent with the Institute of Medicine's six quality aims (safety, effectiveness, timeliness, efficiency, patient-centeredness, and equity), we must influence multiple levels of that multilevel system. The notion that multiple levels of contextual influence affect behaviors through interdependent interactions is a well-established ecological view. This view has been used to analyze health-care delivery and health disparities. However, experience considering multilevel interventions in health care is much less robust. This monograph includes 13 chapters relevant to expanding the foundation of research for multilevel interventions in health-care delivery. Subjects include clinical cases of multilevel thinking in health-care delivery, the state of knowledge regarding multilevel interventions, study design and measurement considerations, methods for combining interventions, time as a consideration in the evaluation of effects, measurement of effects, simulations, application of multilevel thinking to health-care systems and disparities, and implementation of the Affordable Care Act of 2010. Our goal is to outline an agenda to proceed with multilevel intervention research, not because it guarantees improvement in our current approach to health care, but because ignoring the complexity of the multilevel environment in which care occurs has not achieved the desired improvements in care quality outlined by the Institute of Medicine at the turn of the millennium.

Patient outcomes are a primary measure by which we assess healthcare delivery quality. Those outcomes are influenced by numerous other factors in the multilevel context of care described in this monograph (1). Factors include policies that enable or impede health-care access, social support from friends and family, processes of health-care teams, organizational procedures in settings where care is delivered, and the environmental context where these behaviors occur. A few years ago, an internal team of researchers at the National Cancer Institute (NCI) within the Division of Cancer Control and Population Sciences recognized the importance of studying the context in which health care is received to intervene on multiple levels of influence. However, the science of multilevel interventions was in an early stage of development. Thus, the NCI researchers (henceforth “the NCI planning team”) reached out to the extramural community to identify expertise that would help advance this science. The collaborations led to a set of draft articles presented at a conference titled Multilevel Interventions in Health Care: Building a Foundation for Future Research (Las Vegas, NV, March 4–5, 2011). Comments from that conference led to the final articles presented in this issue. The purpose of this article is to describe the relationship between the research articles and the conference to provide richer context for this monograph. We include a summary of the conference events to reflect the complementary development of the articles, to promote more open discussion of the issues among researchers, and to acknowledge the contribution of the meeting participants. In addition, this article summarizes the history behind the conference, its structure, the themes that developed there, and efforts that began after the conference to encourage discussion about multilevel interventions.

This summary reflects on this monograph regarding multilevel intervention (MLI) research to 1) assess its added value; 2) discuss what has been learned to date about its challenges in cancer care delivery; and 3) identify specific ways to improve its scientific soundness, feasibility, policy relevance, and research agenda. The 12 submitted chapters, and discussion of them at the March 2011 multilevel meeting, were reviewed and discussed among the authors to elicit key findings and results addressing the questions raised at the outset of this effort. MLI research is underrepresented as an explicit focus in the cancer literature but may improve implementation of studies of cancer care delivery if they assess contextual, organizational, and environmental factors important to understanding behavioral and/or system-level interventions. The field lacks a single unifying theory, although several psychological or biological theories are useful, and an ecological model helps conceptualize and communicate interventions. MLI research designs are often complex, involving nonlinear and nonhierarchical relationships that may not be optimally studied in randomized designs. Simulation modeling and pilot studies may be necessary to evaluate MLI interventions. Measurement and evaluation of team and organizational interventions are especially needed in cancer care, as are attention to the context of health-care reform, eHealth technology, and genomics-based medicine. Future progress in MLI research requires greater attention to developing and supporting relevant metrics of level effects and interactions and evaluating MLI interventions. MLI research holds an unrealized promise for understanding how to improve cancer care delivery.

Multilevel intervention research holds the promise of more accurately representing real-life situations than single-level intervention research and, thus, with the proper research design and measures, being more likely to facilitate the effective and efficient resolution of complex health-care systems problems (1–3). Taking a multilevel approach to cancer care interventions, however, creates measurement challenges and opportunities. Some measurement issues are similar to those arising in single-level interventions, whereas some are unique to multilevel interventions (4,5). The purpose of this article is to examine the state of measurement in multilevel cancer intervention research and to suggest how opportunities in the field may be addressed by drawing on the measurement literature in other fields. One of the unique aspects of measurement in multilevel intervention research is that consideration of within and between level effects is needed. For multilevel interventions, it is not sufficient to measure effects at the different levels of intervention (eg, patient and health-care team), cross-level effects must also be taken into consideration (eg, the effect of patients on the team and the team on the patients). Furthermore, some measurement issues may be more complex when conducting multilevel intervention research, and some measurement rules of thumb may be uniquely associated with specific levels of analysis (eg, group or organization levels of analysis) (6,7). Because multilevel interventions are based on systems theory [whether general systems (8–10), social ecological systems (11,12), or complex adaptive systems (13) models], they require identification of key constructs and measures by level and consideration of interactions within and across levels (6). Thus, multilevel intervention research benefits from thoughtful planning and design, an interdisciplinary approach, mixed methods (eg, a combination of objective factors, surveys, interviews, observations) measurement and analysis, and careful attention to the congruence of theory, constructs, and measures. Through a systematic review of the literature, this article examines the state of measurement in multilevel cancer care intervention research, identifies measurement opportunities in the field, and draws upon other fields to provide direction about measures and measurement to multilevel cancer care intervention researchers.

Background: Although systems strategies are effective in improving health care delivery, little is known about their use for cancer screening in U.S. primary care practice. Methods: We assessed primary care physicians' (N = 2,475) use of systems strategies for breast, cervical, and colorectal cancer (CRC) screening in a national survey conducted in 2007. Systems strategies included patient and physician screening reminders, performance reports of screening rates, electronic medical records, implementation of in-practice guidelines, and use of nurse practitioners/physician assistants. We evaluated use of both patient and physician screening reminders with other strategies in separate models by screening type, adjusted for the effects of physician and practice characteristics with multivariate logistic regression. Results: Fewer than 10% of physicians used a comprehensive set of systems strategies to support cancer screening; use was greater for mammography and Pap testing than for CRC screening. In adjusted analyses, performance reports of cancer screening rates, medical record type, and in-practice guidelines were associated with use of both patient and physician screening reminders for mammography, Pap testing, and CRC screening (P < 0.05). Conclusion: Despite evidence supporting use of systems strategies in primary care, few physicians report using a comprehensive set of strategies to support cancer screening. Impact: Current health policy initiatives underscore the importance of increased implementation of systems strategies in primary care to improve the use and quality of cancer screening in the United States. Cancer Epidemiol Biomarkers Prev; 20(12); 2471–9. ©2011 AACR.

Advances in genomics and related fields are promising tools for risk assessment, early detection, and targeted therapies across the entire cancer care continuum. In this commentary, we submit that this promise cannot be fulfilled without an enhanced translational genomics research agenda firmly rooted in the population sciences. Population sciences include multiple disciplines that are needed throughout the translational research continuum. For example, epidemiologic studies are needed not only to accelerate genomic discoveries and new biological insights into cancer etiology and pathogenesis, but to characterize and critically evaluate these discoveries in well-defined populations for their potential for cancer prediction, prevention and response to treatment. Behavioral, social, and communication sciences are needed to explore genomic-modulated responses to old and new behavioral interventions, adherence to therapies, decision making across the continuum, and effective use in health care. Implementation science, health services, outcomes research, comparative effectiveness research, and regulatory science are needed for moving validated genomic applications into practice and for measuring their effectiveness, cost-effectiveness, and unintended consequences. Knowledge synthesis, evidence reviews, and economic modeling of the effects of promising genomic applications will facilitate policy decisions and evidence-based recommendations. Several independent and multidisciplinary panels have recently made specific recommendations for enhanced research and policy infrastructure to inform clinical and population research for moving genomic innovations into the cancer care continuum. An enhanced translational genomics and population sciences agenda is urgently needed to fulfill the promise of genomics in reducing the burden of cancer. Cancer Epidemiol Biomarkers Prev; 20(10); 2105–14. ©2011 AACR.

Scientific uncertainty is ubiquitous in health care and information about the benefits and harms of many medical interventions are thus rarely as definitive as most people would prefer. This presents a challenge for patients and physicians who must make decisions in the face of incomplete evidence and conflicting expert opinion. Ethically physicians are obligated to inform patients about uncertainty and alternative options, and to encourage participation in the decision-making process at a level they desire. These obligations represent core elements of shared decision making (SDM), an accepted normative standard of health care. (1–4) Despite the acknowledged importance of communicating scientific uncertainty in health care, there are significant barriers to this practice. Patients may not always prefer information and participation in decision making. (5–8) Deficits in numeracy and health literacy, reduce patients’ capacity to understand information and to participate effectively in decision making. (9, 10) Physician barriers are also important. Most physicians endorse open models of communication; however, 14% endorse limited communication of information and a paternalistic decision making process.(7) There is wide variation in the degree to which physicians actually engage in SDM under conditions of scientific uncertainty.(11) Less than half of physicians’ decision making styles appear to be concordant with patient preferences.(12–14) This discrepancy between physicians’ attitudes and practices has only begun to be explained. Structural factors such as a lack of time and reimbursement have been identified as important barriers. Higher patient volume is associated with less participatory decision making.(8, 11, 15) Individual physician characteristics also play a role. Older age has been shown to predict a lower likelihood of SDM and greater endorsement of paternalistic decision making and communication styles.(16, 17) Physician gender and specialty are also associated with SDM.(11) Emerging evidence also suggests the influence of psychological factors. Physician attitudes regarding the value, usefulness, and scientific justification of SDM vary.(8, 15) Physicians also differ in their capacity to tolerate or deal with uncertainty. These differences may be related to physicians’ medical training and choice of subspecialty, which is reinforced by the training and socialization process in medical school.(11, 18, 19) Differences in physicians ’ tolerance of uncertainty are important to understand, because they may influence the extent to which physicians disclose scientific uncertainty and involve patients in decision making. Lower tolerance of uncertainty has been associated with a lower likelihood of offering a hypothetical new predictive genetic test and disclosing ambiguous test results to patients. (18) This suggests that physicians’ tolerance of uncertainty may influence the extent to which they adopt strategies such as non-directiveness and information disclosure, which are more likely to respect patient autonomy. It is not clear, however, how much these communication strategies are driven by physicians’ own tolerance of uncertainty, as opposed to perceptions of their patients’ tolerance. The perception that patients are intolerant of uncertainty might disincline physicians to fully inform patients about medical decisions marked by uncertainty. The current study examined how physicians’ perceptions of their patients’ tolerance of uncertainty, in addition to physician and practice characteristics, are related to attitudes towards disclosing information and involving patients in decisions about medical interventions characterized by scientific uncertainty. We operationalized tolerance of uncertainty in terms of ambiguity aversion (AA). “Ambiguity” refers to a specific type of uncertainty pertaining to the reliability, credibility, or adequacy of risk information.(20, 21) Ambiguity is high when information is incomplete or conflicting, and leads to pessimistic appraisals of risks and choice outcomes, and avoidance of decision making.(22) This response, known as “ambiguity aversion,” has been demonstrated in decision making domains both in and outside of health care.(23, 24) We were interested in attitudes about the willingness of physicians to communicate about scientific uncertainty and to adopt a shared vs. paternalistic approach towards treatment decisions under conditions of uncertainty. We predicted that physicians who perceived greater AA on the part of their patients would report less favorable attitudes towards informing patients about scientific uncertainty and involving them in decision making. We predicted a similar pattern of results related to practice experience and patient volume, such that those with more experience would have similar attitudes to those who perceived high patient AA.(11, 25) We also explored the influence of other factors such as physicians’ academic affiliation and medical specialty, and patients’ financial status.(8, 15, 18, 19, 26, 27)

The cancer care system is increasingly complex, marked by multiple hand-offs between primary care and specialty providers, inadequate communication among providers, and lack of clarity about a "medical home" (the ideal accountable care provider) for cancer patients. Patients and families often cite such difficulties as information deficits, uncoordinated care, and insufficient psychosocial support. This article presents a review of the challenges of delivering well coordinated, patient-centered cancer care in a complex modern healthcare system. An examination is made of the potential role of information technology (IT) advances to help both providers and patients. Using the published literature as background, a review is provided of selected work that is underway to improve communication, coordination, and quality of care. Also discussed are additional challenges and opportunities to advancing understanding of how patient data, provider and patient involvement, and informatics innovations can support high-quality cancer care.

The National Cancer Institute (NCI) is developing a patient-reported version of its Common Terminology Criteria for Adverse Events, called the "PRO-CTCAE." The PRO-CTCAE consists of a library of patient-reported items which can be administered in clinical trials to directly capture the patient experience of adverse events during cancer treatment, as well as a software platform for administering these items via computer or telephone. In order to better understand the impressions of stakeholders involved in cancer clinical research about the potential value of the PRO-CTCAE approach to capturing adverse event information in clinical research, as well as their perspectives about barriers and strategies for implementing the PRO-CTCAE in NCI-sponsored cancer trials, a survey was conducted. A survey including structured and open-ended questions was developed to elicit perceptions about the use of patient-reported outcomes (PROs) for adverse event reporting, and to explore logistical considerations for implementing the PRO-CTCAE in cancer trials. The survey was distributed electronically and by paper to a convenience sample of leadership and committee members in the NCI's cooperative group network, including principal investigators, clinical investigators, research nurses, data managers, patient advocates, and representatives of the NCI and Food and Drug Administration. Between October, 2008 through February, 2009, 727 surveys were collected. Most respondents (93%) agreed that patient reporting of adverse symptoms would be useful for improving understanding of the patient experience with treatment in cancer trials, and 88%, 80%, and 76%, respectively, endorsed that administration of PRO-CTCAE items in clinical trials would improve the completeness, accuracy, and efficiency of symptom data collection. More than three fourths believed that patient reports would be useful for informing treatment dose modifications and towards FDA regulatory evaluation of drugs. Eighty-eight percent felt that patients in clinical trials would be willing to self-report adverse symptoms at clinic visits via computer, and 68% felt patients would self-report weekly from home via the internet or an automated telephone system. Lack of computers and limited space and personnel were seen as potential barriers to in-clinic self-reporting, but these were judged to be surmountable with adequate funding. The PRO-CTCAE items and software are viewed by a majority of survey respondents as a means to improve adverse event data quality and comprehensiveness, enhance clinical decision-making, and foster patient-clinician communication. Research is ongoing to assess the measurement properties and feasibility of implementing this measure in cancer clinical trials.

Background Anecdotes and limited evidence suggest that a significant percentage of cancer patients encounter troublesome problems in the course of their care. Methods The authors collected data about barriers to and facilitators of high-quality cancer care and innovative solutions to improve quality from three sources: focus groups with patients, family members of cancer patients and providers; site visits to cancer care providers and organisations in three American communities; and expert interviews. Results The authors' respondents consistently described a similar list of problems facing the individual with a suspicion or diagnosis of cancer and his/her family: delays in and lack of coordination of care, patient information gaps and passivity, inadequate attention to emotional and social problems, and difficulty accessing services because of inadequate insurance, limited financial resources or rural residence. The fragmentation and uncertain accountability of cancer care contribute to these issues. Respondents recommended linking patients with a care navigator or manager, using computer technology to better inform and support patients and connect providers, and reforming provider reimbursement to encourage more patient-centred care. Conclusions Cancer patients and their families have urgent needs for information and support especially early in their course. To meet these needs, early cancer care must be better organised, integrated, and patient centred. The Institute of Medicine's Model for the Delivery of Psychosocial Services appears to provide a relevant guide to delivering cancer care that better meets patient and family needs.

Collaboration between QOPI and the NCCCP sites represents an evolution in the QOPI process, in which QOPI provides a metric for measuring quality and serves as a springboard for comprehensive quality improvement across independent but mutually committed practices.

Purpose We surveyed cancer physicians to understand how patients' age and comorbidity influence adjuvant chemotherapy recommendations and whether physician or practice characteristics also affect these recommendations. Methods National survey of surgeons and medical oncologists caring for patients with colorectal cancer regarding whether they would recommend adjuvant chemotherapy for hypothetical patients with stage III colon cancer who varied by age (55 v 80 years) and comorbid illness (none, moderate, severe congestive heart failure [CHF]). Repeated measures logistic regression was used to assess the influence of patient, physician, and practice characteristics on chemotherapy recommendations. Results Of 1,096 physicians, nearly all recommended chemotherapy for patients who were 55 years old with no comorbidity (99.0%), 55-years old with moderate CHF (88.6%), or 80 years old with no comorbidity (92.6%); many fewer recommended chemotherapy for 55-year-old patients with severe CHF (24.9%) or 80-year-old patients with moderate (47.2%) or severe (9.0%) CHF (P < .001). Younger physicians (P < .001) were more likely than others to recommend adjuvant chemotherapy overall, although physician factors explained little of the variability in recommendations. Conclusion Physicians agree with guidelines recommending adjuvant chemotherapy for young, healthy patients with stage III colon cancer but differ widely on recommendations for patients who are older and sicker. Few physician or practice characteristics were associated with recommendations. For older and sicker patients, the individual physicians seen may have a substantial impact on the likelihood of receiving chemotherapy. Understanding better the sources of variation not explained by patients' clinical characteristics may allow improved tailoring of therapy to patients most likely to benefit.

Many of the Institutes, Agencies and Centers that make up the US Department of Health and Human Services (DHHS) have recognized the need for better instrumentation in health outcomes research, and provide support, both internally and externally, for research utilizing advances in measurement theory and computer technology (informatics). In this paper, representatives from several DHHS agencies and institutes will discuss their need for better instruments within their discipline and describe current or future initiatives for exploring the benefits of these technologies. Together, the perspectives underscore the importance of developing valid, precise, and efficient measures to capture the full burden of disease and treatment on patients. Initiatives, like the Patient-Reported Outcomes Measurement Information System (PROMIS) to create health-related quality of life item banks, represent a trans-DHHS effort to develop a standard set of measures for informing decision making in clinical research, practice, and health policy.

Patient-reported outcomes (PROs) measure quality of life, symptoms, patient functioning, and patient perceptions of care; they are essential for gaining a full understanding of cancer care and the impact of cancer on people's lives. Repeatedly captured facility-level and/or population-level PROs (PRO surveillance) could play an important role in quality monitoring and improvement, benchmarking, advocacy, policy making, and research. This article describes the rationale for PRO surveillance and the methods of the Patient Reported Outcomes Symptoms and Side Effects Study (PROSSES), which is the first PRO study to use the American College of Surgeons Commission on Cancer's Rapid Quality Reporting System to identify patients and manage study data flow. The American Cancer Society, the National Cancer Institute, the Commission on Cancer, and RTI International collaborated on PROSSES. PROSSES was conducted at 17 cancer programs that participated in the National Cancer Institute Community Cancer Centers Program among patients diagnosed with locoregional breast or colon cancer. The methods piloted in PROSSES were successful as demonstrated by high eligibility (93%) and response (61%) rates. Differences in clinical and demographic characteristics between respondents and nonrespondents were mostly negligible, with the exception that non-white individuals were somewhat less likely to respond. These methods were consistent across cancer centers and reproducible over time. If repeated and expanded, they could provide PRO surveillance data from patients with cancer on a national scale.

The use of performance measurement to inform macro-level studies of cancer control and quality of care is receiving increasing interest at the state, national, and international level. This article describes the use of these measures to inform health policy and monitor cancer disparities and disease burden. Applications are discussed in clinical and provider-reported outcomes such as cancer incidence, mortality and survival, and outcome-linked processes of care, and patient-reported outcomes such as health-related quality of life and patient satisfaction/experience with care. The use of economic measures to monitor and evaluate the burden of illness is also discussed. The growing demand for surveillance capability coupled with the need to expand both the quality and breadth of available measure sets, suggests that there is a need to supplement traditional clinical and provider-reported process and outcomes measures with patient-reported outcomes measures such as health-related quality of life and patient satisfaction and experience with care. In addition, there is also a need to broaden and standardize outcome-linked process-of-care measures to improve the ability to measure and monitor incremental progress in improving cancer care. Finally, better measures of indirect costs of cancer care, such as loss productivity and caregiver burden among the aged, would improve national estimates of the cost of illness associated with cancer.

Background: Population trends in aging and improved cancer survival are likely to result in increased cancer prevalence in the United States, but few estimates of the burden of illness among cancer survivors are currently available. The purpose of this study was to estimate the burden of illness in cancer survivors in a national, population-based sample. Methods: A total of 1823 cancer survivors and 5469 age-, sex-, and educational attainment-matched control subjects were identified from the 2000 National Health Interview Survey. Multiple measures of burden, including utility, a measure of health, and days lost from work, were compared using two-sided tests of statistical significance for the two groups overall and for subgroups stratified by tumor site and time since diagnosis. Results: Compared with matched control subjects, cancer survivors had poorer outcomes across all burden measures (P

The National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP) began in 2007; it is a network of community-based hospitals funded by the NCI. Quality of care is an NCCCP priority, with participation in the American Society of Clinical Oncology Quality Oncology Practice Initiative (QOPI) playing a fundamental role in quality assessment and quality improvement (QI) projects. Using QOPI methodology, performance on quality measures was analyzed two times per year over a 3-year period to enhance our implementation of quality standards at NCCCP hospitals.A data-sharing agreement allowed individual-practice QOPI data to be electronically sent to the NCI. Aggregated data with the other NCCCP QOPI participants were presented to the network via Webinars. The NCCCP Quality of Care Subcommittee selected areas in which to focus subsequent QI efforts, and high-performing practices shared voluntarily their QI best practices with the network.QOPI results were compiled semiannually between fall 2010 and fall 2013. The network concentrated on measures with a quality score of ≤ 0.75 and planned voluntary group-wide QI interventions. We identified 13 measures in which the NCCCP fell at or below the designated quality score in fall 2010. After implementing a variety of QI initiatives, the network registered improvements in all parameters except one (use of treatment summaries).Using the NCCCP as a paradigm, QOPI metrics provide a useful platform for group-wide measurement of quality performance. In addition, these measurements can be used to assess the effectiveness of QI initiatives.