Financial toxicity among people with metastatic cancer: findings from the Cancer Experience Registry.

PURPOSE: This study describes financial toxicity (FT) reported by people with metastatic cancer, characteristics associated with FT, and associations between FT and compensatory strategies to offset costs. METHODS: Cancer Support Community's Cancer Experience Registry data was used to identify respondents with a solid tumor metastatic cancer who completed the Functional Assessment of Chronic Illness Therapy COmprehensive Score for Financial Toxicity (FACIT-COST) measure. Multivariable logistic regression analyses examined associations between respondent characteristics and FT, and FT and postponing medical visits, nonadherence to medications, and postponing supportive and/or psychosocial care. RESULTS: 484 individuals were included in the analysis; the most common cancers included metastatic breast (31%), lung (13%), gynecologic (10%), and colorectal (9%). Approximately half of participants (50.2%) reported some degree of FT. Those who were non-Hispanic White, Hispanic, or multiple races (compared to non-Hispanic Black), and who reported lower income, less education, and being less than one year since their cancer diagnosis had greater odds of reporting FT. Individuals with any level of FT were also more likely to report postponing medical visits (Adjusted Odds Ratio [OR] 2.58; 95% Confidence Interval [CI] 1.45-4.58), suboptimal medication adherence (Adjusted OR 5.05; 95% CI 2.77-9.20) and postponing supportive care and/or psychosocial support services (Adjusted OR 4.16; 95% CI 2.53-6.85) compared to those without FT. CONCLUSIONS: With increases in the number of people living longer with metastatic cancer and the rising costs of therapy, there will continue to be a need to systematically screen and intervene to prevent and mitigate FT for these survivors.

Seeing the whole elephant - How lobstermen's local ecological knowledge can inform fisheries management.

Lobstermen in Southern New England come from a longstanding intergenerational fishing tradition. Their local ecological knowledge (LEK) on the American lobster, Homarus americanus can be an important source of information for management. This paper examines lobstermen's LEK as it relates to stock assessment and the overlap to science based ecological knowledge (SEK). Although in recent years, using vent-less trap assessments and conducting young of the year surveys, has set the stage for more cooperative research, in our opinion, lobstermen's LEK remains underutilized in fisheries management. There has been a steady decline in the lobster stocks over the years, raising concerns regarding fisheries management. For this reason, we turn to lobstermen's knowledge as an important source that could inform fisheries management. Using a semi-structured approach, the stakeholders' LEK and open discussions were recorded during three meetings where lobstermen participated with managers and scientists. LEK was transcribed and categorized and matched to the corresponding SEK described in the literature. Results generally found that the lobstermen's LEK corresponded with the best available SEK. LEK is compatible with an ecosystem view of the fishery that integrates the complexities of interacting systems. The lobstermen explained that they viewed their fishing grounds as "managed landscapes", areas used productively, maintained and protected by them. These results are a starting point to broaden the base of the knowledge used in fisheries management enabling us to see the whole picture. Topics of LEK and SEK convergence are promising common ground, while topics where lobstermen and managers' views differ, can serve as points of entry to enable research and cooperative management. Both can be the basis for cooperative hypothesis testing.

Outcomes of multidisciplinary treatment planning in US cancer care settings.

Multidisciplinary treatment planning (MTP) is a process of engaging multiple disciplines to develop or refine the disease management plan. It is widely implemented in US cancer treatment settings and is considered to have favorable effects on both care quality and other outcomes. However, evidence reviews to date regarding MTP effectiveness have based their conclusions on studies conducted predominantly outside the United States. The authors conducted a systematic review of US-based studies to synthesize and critically appraise evidence of the effects of MTP on cancer care quality, health services outcomes, and survival. Database searches identified studies of MTP outcomes conducted in US cancer care settings from 2000 to 2017. Forty-five studies met criteria for inclusion. MTP was associated with favorable effects on several indicators of cancer care quality, including delivery of guideline-concordant treatment and improvements in diagnostic accuracy, staging completeness, surgical technique, and timeliness. Effects on survival and clinical trials enrollment were mixed. Delivery formats for MTP were generally not well described, and study designs were nonrandomized, limiting the ability to identify mediators of intervention effects. Continued study is warranted to clarify effective components of MTP interventions, and to understand the mechanism(s) through which MTP produces favorable effects on outcomes.

Ontogenetic allometry conservatism across five teleost orders.

Geometric morphometrics were used to analyse ontogenetic trajectories in representatives of the Characiformes, Cichliformes, Cyprinodontiformes, Siluriformes, and Tetraodontiformes. It was not possible to differentiate any allometric growth patterns across groups, indicating that a phylogenetically conserved developmental pattern is widespread throughout Teleostei.

Evaluation of different recall periods for the US National Cancer Institute's PRO-CTCAE.

AIMS: The US National Cancer Institute recently developed the PRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events). PRO-CTCAE is a library of questions for clinical trial participants to self-report symptomatic adverse events (e.g. nausea). The objective of this study is to inform evidence-based selection of a recall period when PRO-CTCAE is included in a trial. We evaluated differences between 1-, 2-, 3-, and 4-week recall periods, using daily reporting as the reference. METHODS: English-speaking patients with cancer receiving chemotherapy and/or radiotherapy were enrolled at four US cancer centers and affiliated community clinics. Participants completed 27 PRO-CTCAE items electronically daily for 28 days, and then weekly over 4 weeks, using 1-, 2-, 3-, and 4-week recall periods. For each recall period, mean differences, effect sizes, and intraclass correlation coefficients were calculated to evaluate agreement between the maximum of daily ratings and the corresponding ratings obtained using longer recall periods (e.g. maximum of daily scores over 7 days vs 1-week recall). Analyses were repeated using the average of daily scores within each recall period rather than the maximum of daily scores. RESULTS: A total of 127 subjects completed questionnaires (57% male; median age: 57). The median of the 27 mean differences in scores on the PRO-CTCAE 5-point response scale comparing the maximum daily versus the longer recall period (and corresponding effect size) was -0.20 (-0.20) for 1-week recall, -0.36 (-0.31) for 2-week recall, -0.45 (-0.39) for 3-week recall, and -0.47 (-0.40) for 4-week recall. The median intraclass correlation across 27 items between the maximum of daily ratings and the corresponding longer recall ratings for 1-week recall was 0.70 (range: 0.54-0.82), for 2-week recall was 0.74 (range: 0.58-0.83), for 3-week recall was 0.72 (range: 0.61-0.84), and for 4-week recall was 0.72 (range: 0.64-0.86). Similar results were observed for all analyses using the average of daily scores rather than the maximum of daily scores. CONCLUSION: A 1-week recall corresponds best to daily reporting. Although intraclass correlations remain stable over time, there are small but progressively larger differences between daily and longer recall periods at 2, 3, and 4 weeks, respectively. The preferred recall period for the PRO-CTCAE is the past 7 days, although investigators may opt for recall periods of 2, 3, or 4 weeks with an understanding that there may be some information loss.

The rationale for patient-reported outcomes surveillance in cancer and a reproducible method for achieving it.

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.

Mode equivalence and acceptability of tablet computer-, interactive voice response system-, and paper-based administration of the U.S. National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

BACKGROUND: PRO-CTCAE is a library of items that measure cancer treatment-related symptomatic adverse events (NCI Contracts: HHSN261201000043C and HHSN 261201000063C). The objective of this study is to examine the equivalence and acceptability of the three data collection modes (Web-enabled touchscreen tablet computer, Interactive voice response system [IVRS], and paper) available within the US National Cancer Institute (NCI) Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measurement system. METHODS: Participants (n = 112; median age 56.5; 24 % high school or less) receiving treatment for cancer at seven US sites completed 28 PRO-CTCAE items (scoring range 0-4) by three modes (order randomized) at a single study visit. Subjects completed one page (approx. 15 items) of the EORTC QLQ-C30 between each mode as a distractor. Item scores by mode were compared using intraclass correlation coefficients (ICC); differences in scores within the 3-mode crossover design were evaluated with mixed-effects models. Difficulties with each mode experienced by participants were also assessed. RESULTS: 103 (92 %) completed questionnaires by all three modes. The median ICC comparing tablet vs IVRS was 0.78 (range 0.55-0.90); tablet vs paper: 0.81 (0.62-0.96); IVRS vs paper: 0.78 (0.60-0.91); 89 % of ICCs were ≥0.70. Item-level mean differences by mode were small (medians [ranges] for tablet vs. IVRS = -0.04 [-0.16-0.22]; tablet vs paper = -0.02 [-0.11-0.14]; IVRS vs paper = 0.02 [-0.07-0.19]), and 57/81 (70 %) items had bootstrapped 95 % CI around the effect sizes within +/-0.20. The median time to complete the questionnaire by tablet was 3.4 min; IVRS: 5.8; paper: 4.0. The proportion of participants by mode who reported "no problems" responding to the questionnaire was 86 % tablet, 72 % IVRS, and 98 % paper. CONCLUSIONS: Mode equivalence of items was moderate to high, and comparable to test-retest reliability (median ICC = 0.80). Each mode was acceptable to a majority of respondents. Although the study was powered to detect moderate or larger discrepancies between modes, the observed ICCs and very small mean differences between modes provide evidence to support study designs that are responsive to patient or investigator preference for mode of administration, and justify comparison of results and pooled analyses across studies that employ different PRO-CTCAE modes of administration. TRIAL REGISTRATION: NCT Clinicaltrials.gov identifier: NCT02158637.

Survivorship concerns among individuals diagnosed with metastatic cancer: Findings from the Cancer Experience Registry.

INTRODUCTION: Individuals with metastatic cancer experience many medical, physical, and emotional challenges due to changing medical regimens, oscillating disease states, and side effects. The purpose of this study was to describe the type and prevalence of survivorship concerns reported by individuals with metastatic cancer, and their associations with cancer diagnosis, treatment, and socio-demographic variables. METHODS: This study utilized data from the Cancer Support Community's Cancer Experience Registry. Individuals were included if they self-reported a solid tumor metastatic cancer and completed CancerSupportSource, which evaluates five domains of concerns (emotional well-being, symptom burden, body image/healthy lifestyle, healthcare team communication, and relationships/intimacy). Multivariable linear regression examined associations between independent predictors of each survivorship concern domain. RESULTS: Of the 403 included participants, individuals reported a metastatic diagnosis of breast (43%), colorectal (20%), prostate (7%), lung (7%), gynecologic cancer (6%) and other. Nearly all (96%) reported at least one survivorship concern, with the most prevalent concern about cancer progression or recurrence. Survivorship concerns were higher across multiple domains for individuals unemployed due to disability. Individuals who were less than five years since diagnosis reported higher concerns related to emotional well-being, symptom burden, and healthcare communication compared to those more than five years since diagnosis. CONCLUSION: Individuals with metastatic cancer experience a variety of moderate-to-severe survivorship concerns that warrant additional investigation. IMPLICATIONS FOR CANCER SURVIVORS: As the population of individuals with metastatic cancer lives longer, future research must investigate solutions to address modifiable factors associated with survivorship concerns, such as unemployment due to disability.

Epizootic shell disease in American lobsters Homarus americanus in southern New England: past, present and future.

The emergence of epizootic shell disease in American lobsters Homarus americanus in the southern New England area, USA, has presented many new challenges to understanding the interface between disease and fisheries management. This paper examines past knowledge of shell disease, supplements this with the new knowledge generated through a special New England Lobster Shell Disease Initiative completed in 2011, and suggests how epidemiological tools can be used to elucidate the interactions between fisheries management and disease.

Thematic Analysis of Organizational Characteristics in NCI Community Oncology Research Program Cancer Care Delivery Research.

Organizational characteristics, including organizational structures and processes, are important to understanding care delivery and health outcomes. However, organizational-level constructs present measurement challenges in care delivery research. This analysis aims to understand if, when, and how organizational characteristics are examined in a National Cancer Institute (NCI) research network conducting cancer care delivery research (CCDR). The NCI Community Oncology Research Program encourages consideration of organizational variables in CCDR studies. We conducted a cross-sectional thematic analysis to identify organizational characteristics examined in this portfolio of research. Organizational characteristics targeted, related measures, and analytic approach were abstracted by 2 study investigators using a coding framework adapted from 2 existing frameworks. A total of 78.9% of eligible study protocols included organizational characteristics. Structural characteristics were the most common, collected in all 15 included protocols, 14 examined at least 1 organizational process, and 12 examined organizational-level outcomes. Most studies proposed descriptive practice-level analyses or multilevel analyses using random effects to account for clustering of patients and staff within practices. Few (n = 5) specified that organizational variables would be modeled as effects of interest (vs covaried out) or proposed analytic approaches that could more robustly examine effects of targeted organizational characteristics on primary outcomes. Inclusion of organizational variables is common in CCDR conducted through the NCI Community Oncology Research Program, NCI's national network charged with bringing cancer clinical trials to people in their communities. Nonetheless, opportunities remain to improve the use of theory to guide organizational construct selection, operationalization, measurement, and incorporation into study hypotheses and analyses.

Water constraints drive allometric patterns in the body shape of tree frogs.

The origin of morphological diversity is a critical question in evolutionary biology. Interactions between the environment and developmental processes have determining roles in morphological diversity, creating patterns through space and over time. Also, the shape of organisms tends to vary with increasing size as a result of those developmental processes, known as allometry. Several studies have demonstrated that the body sizes of anurans are associated with hydric conditions in their environments and that localities with high water stress tend to select for larger individuals. However, how environmental conditions alter those patterns of covariance between size and shape is still elusive. We used 3D geometric morphometric analyses, associated with phylogenetic comparative methods, to determine if the morphological variations and allometric patterns found in Arboranae (Anura) is linked to water conservation mechanisms. We found effects of the hydric stress on the shape of Arboranae species, favouring globular shapes. Also, the allometric patterns varied in intensity according to the water stress gradient, being particularly relevant for smaller frogs, and more intense in environments with higher water deficits. Our study provides empirical evidence that more spherical body shapes, especially among smaller species, reflect an important adaptation of anurans to water conservation in water-constrained environments.

Evolution of Cancer Care Delivery Research in the NCI Community Oncology Research Program.

Research seeking to improve patient engagement with decision-making, use of evidence-based guidelines, and coordination of multi-specialty care has made important contributions to the decades-long effort to improve cancer care. The National Cancer Institute expanded support for these efforts by including cancer care delivery research in the 2014 formation of the National Cancer Institute Community Oncology Research Program (NCORP). Cancer care delivery research is a multi-disciplinary effort to generate evidence-based practice change that improves clinical outcomes and patient well-being. NCORP scientists and community-based clinicians and organizations rapidly embraced the addition of this type of research into the network, resulting in a robust portfolio of observational studies and intervention studies within the first 5 years of funding. This commentary describes the initial considerations in conducting this type of research in a network previously focused on cancer prevention, control, and treatment studies; characterizes the protocols developed to date; and outlines future directions for cancer care delivery research in the second round of NCORP funding.

Perceptions of Patients With Breast and Colon Cancer of the Management of Cancer-Related Pain, Fatigue, and Emotional Distress in Community Oncology.

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.

Perspectives on Palliative Care in Cancer Clinical Trials: Diverse Meanings from Multidisciplinary Cancer Care Providers.

BACKGROUND: Palliative care (PC) is often misunderstood as exclusively pertaining to end-of-life care, which may be consequential for its delivery. There is little research on how PC is operationalized and delivered to cancer patients enrolled in clinical trials. OBJECTIVE: We sought to understand the diverse perspectives of multidisciplinary oncology care providers caring for such patients in a teaching hospital. METHODS: We conducted qualitative semistructured interviews with 19 key informants, including clinical trial principal investigators, oncology fellows, research nurses, inpatient and outpatient nurses, spiritual care providers, and PC fellows. Questions elicited information about the meaning providers assigned to the term "palliative care," as well as their experiences with the delivery of PC in the clinical trial context. Using grounded theory, a team-based coding method was employed to identify major themes. RESULTS: Four main themes emerged regarding the meaning of PC: (1) the holistic nature of PC, (2) the importance of symptom care, (3) conflict between PC and curative care, and (4) conflation between PC and end-of-life care. Three key themes emerged with regard to the delivery of PC: (1) dynamics among providers, (2) discussing PC with patients and family, and (3) the timing of PC delivery. CONCLUSION: There was great variability in personal meanings of PC, conflation with hospice/end-of-life care, and appropriateness of PC delivery and timing, particularly within cancer clinical trials. A standard and acceptable model for integrating PC concurrently with treatment in clinical trials is needed.

ReCAP: Impact of Multidisciplinary Care on Processes of Cancer Care: A Multi-Institutional Study.

PURPOSE: The role of multidisciplinary care (MDC) on cancer care processes is not fully understood. We investigated the impact of MDC on the processes of care at cancer centers within the National Cancer Institute Community Cancer Centers Program (NCCCP). METHODS: The study used data from patients diagnosed with stage IIB to III rectal cancer, stage III colon cancer, and stage III non­small-cell lung cancer at 14 NCCCP cancer centers from 2007 to 2012. We used an MDC development assessment tool­with levels ranging from evolving MDC (low) to achieving excellence (high)­to measure the level of MDC implementation in seven MDC areas, such as case planning and physician engagement. Descriptive statistics and cluster-adjusted regression models quantified the association between MDC implementation and processes of care, including time from diagnosis to treatment receipt. RESULTS: A total of 1,079 patients were examined. Compared with patients with colon cancer treated at cancer centers reporting low MDC scores, time to treatment receipt was shorter for patients with colon cancer treated at cancer centers reporting high or moderate MDC scores for physician engagement (hazard ratio [HR] for high physician engagement, 2.66; 95% CI, 1.70 to 4.17; HR for moderate physician engagement, 1.50; 95% CI, 1.19 to 1.89) and longer for patients with colon cancer treated at cancer centers reporting high 2MDC scores for case planning (HR, 0.65; 95% CI, 0.49 to 0.85). Results for patients with rectal cancer were qualitatively similar, and there was no statistically significant difference among patients with lung cancer. CONCLUSION: MDC implementation level was associated with processes of care, and direction of association varied across MDC assessment areas.

Assessing the Development of Multidisciplinary Care: Experience of the National Cancer Institute Community Cancer Centers Program.

PURPOSE: The National Cancer Institute Community Cancer Centers Program (NCCCP) began in 2007 with a goal of expanding cancer research and delivering quality care in communities. The NCCCP Quality of Care (QoC) Subcommittee was charged with developing and improving the quality of multidisciplinary care. An assessment tool with nine key elements relevant to MDC structure and operations was developed. METHODS: Fourteen NCCCP sites reported multidisciplinary care assessments for lung, breast, and colorectal cancer in June 2010, June 2011, and June 2012 using an online reporting tool. Each site evaluated their level of maturity (level 1 = no multidisciplinary care, level 5 = highly integrated multidisciplinary care) in nine elements integral to multidisciplinary care. Thematic analysis of open-ended qualitative responses was also conducted. RESULTS: The proportion of sites that reported level 3 or greater on the assessment tool was tabulated at each time point. For all tumor types, sites that reached this level increased in six elements: case planning, clinical trials, integration of care coordination, physician engagement, quality improvement, and treatment team integration. Factors that enabled improvement included increasing organizational support, ensuring appropriate physician participation, increasing patient navigation, increasing participation in national quality initiatives, targeting genetics referrals, engaging primary care providers, and integrating clinical trial staff. CONCLUSIONS: Maturation of multidisciplinary care reflected focused work of the NCCCP QoC Subcommittee. Working group efforts in patient navigation, genetics, and physician conditions of participation were evident in improved multidisciplinary care performance for three common malignancies. This work provides a blueprint for health systems that wish to incorporate prospective multidisciplinary care into their cancer programs.

Quality improvement in the national cancer institute community cancer centers program: the quality oncology practice initiative experience.

PURPOSE: 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. METHODS: 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. RESULTS: 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). CONCLUSION: 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.

Cancer Care Delivery Research: Building the Evidence Base to Support Practice Change in Community Oncology.

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.

Validity and Reliability of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

IMPORTANCE: To integrate the patient perspective into adverse event reporting, the National Cancer Institute developed a patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). OBJECTIVE: To assess the construct validity, test-retest reliability, and responsiveness of PRO-CTCAE items. DESIGN, SETTING, AND PARTICIPANTS: A total of 975 adults with cancer undergoing outpatient chemotherapy and/or radiation therapy enrolled in this questionnaire-based study between January 2011 and February 2012. Eligible participants could read English and had no clinically significant cognitive impairment. They completed PRO-CTCAE items on tablet computers in clinic waiting rooms at 9 US cancer centers and community oncology practices at 2 visits 1 to 6 weeks apart. A subset completed PRO-CTCAE items during an additional visit 1 business day after the first visit. MAIN OUTCOMES AND MEASURES: Primary comparators were clinician-reported Eastern Cooperative Oncology Group Performance Status (ECOG PS) and the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30). RESULTS: A total of 940 of 975 (96.4%) and 852 of 940 (90.6%) participants completed PRO-CTCAE items at visits 1 and 2, respectively. At least 1 symptom was reported by 938 of 940 (99.8%) participants. Participants' median age was 59 years; 57.3% were female, 32.4% had a high school education or less, and 17.1% had an ECOG PS of 2 to 4. All PRO-CTCAE items had at least 1 correlation in the expected direction with a QLQ-C30 scale (111 of 124, P<.05 for all). Stronger correlations were seen between PRO-CTCAE items and conceptually related QLQ-C30 domains. Scores for 94 of 124 PRO-CTCAE items were higher in the ECOG PS 2 to 4 vs 0 to 1 group (58 of 124, P<.05 for all). Overall, 119 of 124 items met at least 1 construct validity criterion. Test-retest reliability was 0.7 or greater for 36 of 49 prespecified items (median [range] intraclass correlation coefficient, 0.76 [0.53-.96]). Correlations between PRO-CTCAE item changes and corresponding QLQ-C30 scale changes were statistically significant for 27 prespecified items (median [range] r=0.43 [0.10-.56]; all P≤.006). CONCLUSIONS AND RELEVANCE: Evidence demonstrates favorable validity, reliability, and responsiveness of PRO-CTCAE in a large, heterogeneous US sample of patients undergoing cancer treatment. Studies evaluating other measurement properties of PRO-CTCAE are under way to inform further development of PRO-CTCAE and its inclusion in cancer trials.