Prospective assessment of patient-reported outcomes and estradiol and drug concentrations in patients experiencing toxicity from adjuvant aromatase inhibitors.

PURPOSE: Aromatase inhibitors (AI), which decrease circulating estradiol concentrations in post-menopausal women, are associated with toxicities that limit adherence. Approximately one-third of patients will tolerate a different AI after not tolerating the first. We report the effect of crossover from exemestane to letrozole or vice versa on patient-reported outcomes (PROs) and whether the success of crossover is due to lack of estrogen suppression. METHODS: Post-menopausal women enrolled on a prospective trial initiating AI therapy for early-stage breast cancer were randomized to exemestane or letrozole. Those that discontinued for intolerance were offered protocol-directed crossover to the other AI after a washout period. Changes in PROs, including pain [Visual Analog Scale (VAS)] and functional status [Health Assessment Questionnaire (HAQ)], were compared after 3 months on the first versus the second AI. Estradiol and drug concentrations were measured. RESULTS: Eighty-three patients participated in the crossover protocol, of whom 91.3% reported improvement in symptoms prior to starting the second AI. Functional status worsened less after 3 months with the second AI (HAQ mean change AI #1: 0.2 [SD 0.41] vs. AI #2: -0.05 [SD 0.36]; p = 0.001); change in pain scores was similar between the first and second AI (VAS mean change AI #1: 0.8 [SD 2.7] vs. AI #2: -0.2 [SD 2.8]; p = 0.19). No statistical differences in estradiol or drug concentrations were found between those that continued or discontinued AI after crossover. CONCLUSIONS: Although all AIs act via the same mechanism, a subset of patients intolerant to one AI report improved PROs with a different one. The mechanism of this tolerance remains unknown, but does not appear to be due to non-adherence to, or insufficient estrogen suppression by, the second AI.

Is It Okay To Ask: Transgender Patient Perspectives on Sexual Orientation and Gender Identity Collection in Healthcare.

OBJECTIVE: The National Academy of Medicine and Joint Commission recommend routine documentation of sexual orientation (SO) and gender identity (GI) in healthcare to address lesbian, gay, bisexual, or transgender (LGBT) health disparities. We explored transgender patient-reported views on the importance on SO/GI collection, their willingness to disclose, and their perceived facilitators of SO/GI collection in primary care and emergency department (ED) settings. METHODS: We recruited a national sample of self-identified transgender patients. Participants completed demographic questions, survey questions, and free-response comments regarding their views on SO/GI collection. Data were analyzed using descriptive statistics; inductive content analysis was conducted with open-ended responses. RESULTS: Patients mostly self-identified as male gender (54.5%), white (58.4%), and SO other than heterosexual or LGB (33.7%; N = 101). Patients felt that it was more important for primary care providers to know their GI than SO (89.1% vs. 57%; p < 0.001); there was no difference among reported importance for ED providers to know the patients' SO versus GI. Females were more likely than males to report medical relevance to chief complaint as a facilitator to SO disclosure (89.1% vs. 80%; p = 0.02) and less likely to identify routine collection from all patients as a facilitator to GI disclosure (67.4% vs. 78.2%; p = 0.09). Qualitatively, many patients reported that medical relevance to chief complaint and an LGBT-friendly environment would increase willingness to disclose their SO/GI. Patients also reported need for educating providers in LGBT health prior to implementing routine SO/GI collection. CONCLUSIONS: Patients see the importance of providing GI more than SO to providers; nonetheless they are willing to disclose SO/GI in general.. Findings also suggest that gender differences may exist in facilitators of SO/GI disclosure. Given the underrepresentation of transgender patients in healthcare, it is crucial for providers to address their concerns with SO/GI disclosure, which include LGBT education for medical staff and provision of a safe environment.

Relationship Between Quality of Comorbid Condition Care and Costs for Cancer Survivors.

PURPOSE: To estimate the association between cancer survivors' comorbid condition care quality and costs; to determine whether the association differs between cancer survivors and other patients. METHODS: Using the SEER-Medicare-linked database, we identified survivors of breast, prostate, and colorectal cancers who were diagnosed in 2004, enrolled in Medicare fee-for-service for at least 12 months before diagnosis, and survived ≥ 3 years. Quality of care was assessed using nine process indicators for chronic conditions, and a composite indicator representing seven avoidable outcomes. Total costs on the basis of Medicare amount paid were grouped as inpatient and outpatient. We examined the association between care quality and costs for cancer survivors, and compared this association among 2:1 frequency-matched noncancer controls, using comparisons of means and generalized linear regressions. RESULTS: Our sample included 8,661 cancer survivors and 17,332 matched noncancer controls. Receipt of recommended care was associated with higher outpatient costs for eight indicators, and higher inpatient and total costs for five indicators. For three measures (visit every 6 months for patients with chronic obstructive pulmonary disease or diabetes, and glycosylated hemoglobin or fructosamine every 6 months for patients with diabetes), costs for cancer survivors who received recommended care increased less than for noncancer controls. The absence of avoidable events was associated with lower costs of each type. An annual eye examination for patients with diabetes was associated with lower inpatient costs. CONCLUSION: Higher-quality processes of care may not reduce short-term costs, but the prevention of avoidable outcomes reduces costs. The association between quality and cost was similar for cancer survivors and noncancer controls.

Identifying cutoff scores for the EORTC QLQ-C30 and the head and neck cancer-specific module EORTC QLQ-H&N35 representing unmet supportive care needs in patients with head and neck cancer.

BACKGROUND: This study investigates cutoff scores for the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30-questions (EORTC QLQ-C30) and head and neck cancer-specific module (QLQ-H&N35) to identify patients with head and neck cancer who may require clinical attention. METHODS: Ninety-six patients with head and neck cancer completed the EORTC QLQ-C30/H&N35 and questions on supportive care needs. For all EORTC domains with the ability to discriminate between patients with and without unmet needs (area under the receiver operating characteristic curve [AUC] ≥0.70), the accuracy (eg, sensitivity and specificity) of potential cutoff scores were calculated. RESULTS: Cutoff scores (sensitivity ≥0.80 and specificity ≥0.60) of 90 (functioning domains) and 5 to 10 (symptom domains) were found on 7 of 28 continuous EORTC QLQ-C30/H&N35 domains. Borderline cutoff scores (sensitivity ≥0.70 and specificity ≥0.60 or sensitivity ≥0.80 and specificity ≥0.50) were found on 5 other domains. CONCLUSIONS: This study provided cutoff scores on the EORTC QLQ-C30 and H&N35 based on patients' perceptions of their needs for supportive care. Future research is needed on the replicability of these cutoff scores. © 2015 Wiley Periodicals, Inc. Head Neck 38: E1493-E1500, 2016.

Identifying changes in scores on the EORTC-QLQ-C30 representing a change in patients' supportive care needs.

PURPOSE: Using health-related quality-of-life measures for patient management requires knowing what changes in scores require clinical attention. We estimated changes on the European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Core-30 (EORTC-QLQ-C30), representing important changes by comparing to patient-reported changes in supportive care needs. METHODS: This secondary analysis used data from 193 newly diagnosed cancer patients (63 % breast, 37 % colorectal; mean age 60 years; 20 % male) from 28 Canadian surgical practices. Participants completed the Supportive Care Needs Survey-Short Form-34 (SCNS-SF34) and EORTC-QLQ-C30 at baseline, 3, and 8 weeks. We calculated mean changes in EORTC-QLQ-C30 scores associated with improvement, worsening, and no change in supportive care needs based on the SCNS-SF34. Mean changes in the EORTC-QLQ-C30 scores associated with the SCNS-SF34 improved and worsened categories were used to estimate clinically important changes, and the 'no change' category to estimate insignificant changes. RESULTS: EORTC-QLQ-C30 score changes ranged from 6 to 32 points for patients reporting improved supportive care needs; statistically significant changes were 10-32 points. EORTC-QLQ-C30 score changes ranged from 21-point worsening to 21-point improvement for patients reporting worsening supportive care needs; statistically significant changes were 9-21 points in the hypothesized direction and a 21-point statistically significant change in the opposite direction. EORTC-QLQ-C30 score changes ranged from a 1-point worsening to 16-point improvement for patients reporting stable supportive care needs. CONCLUSION: These data suggest 10-point EORTC-QLQ-C30 score changes represent changes in supportive care needs. When using the EORTC-QLQ-C30 in clinical practice, scores changing ≥10 points should be highlighted for clinical attention.

Cancer patients' function, symptoms and supportive care needs: a latent class analysis across cultures.

PURPOSE: Patient-reported outcomes (PROs) are an umbrella term covering a range of outcomes, including symptoms, functioning, health-related quality of life, and supportive care needs. Research regarding the appropriate PRO questionnaires to use is informative. A previously published latent class analysis (LCA) examined patterns of function, symptoms, and supportive care needs in a sample of US cancer patients. The current analysis investigated whether the findings from the original study were replicated in new samples from different countries and whether a larger sample combining all the data would affect the classes identified. METHODS: This secondary analysis of data from 408 Japanese and 189 Canadian cancer patients replicated the methods used in the original LCA using data from 117 US cancer patients. In all samples, subjects completed the EORTC-QLQ-C30 and Supportive Care Needs Survey Short Form-34 (SCNS-SF34). We first dichotomized individual function, symptom, and need domain scores. We then performed LCA to investigate the patterns of domains for each of the outcomes, both in the individual country samples and then combining the data from all three samples. RESULTS: Across all analyses, class assignment was made by level of function, symptoms, or needs. In individual samples, only two-class models ("high" vs. "low") were generally identifiable while in the combined sample, three-class models ("high" vs. "moderate" vs. "low") best fit the data for all outcomes. CONCLUSIONS: In this analysis, the level of burden experienced by patients was the key factor in defining classes.

American Society of Clinical Oncology clinical expert statement on cancer survivorship care planning.

The seminal report from the Institute of Medicine, "From Cancer Patient to Cancer Survivor: Lost in Transition," identified four essential components of survivorship care and recommended that a survivorship care plan (SCP), consisting of a treatment summary and follow-up care plan, be developed and used as a tool to deliver patient-centered care by enhancing communication between the oncology team and the patient as well as communication and coordination of care between the oncology team and the primary care provider (PCP). Nearly a decade ago, the American Society of Clinical Oncology (ASCO) initiated a series of activities to promote chemotherapy treatment plans and summaries and SCPs. Unfortunately, there has been limited success in implementing SCPs in oncology practice because of barriers including, but not limited to, the time-consuming process of completing an SCP, lack of role clarity, and lack of reimbursement for preparation time. ASCO developed this statement and revised template to provide a framework for completing and sharing SCPs and to set clear expectations for survivorship care planning in the oncology setting. This statement is intended to help clinicians recognize the importance of developing patient-centered SCPs and delivering the information to both the patient and PCP and to identify barriers that may exist in completing and delivering these documents effectively.

It's who you know: patient-sharing, quality, and costs of cancer survivorship care.

PURPOSE: Cancer survivors frequently receive care from a large number of physicians, creating challenges for coordination. We sought to explore whether cancer survivors whose providers have more patients in common (e.g., shared patients) tend to have higher quality and lower cost care. METHODS: We performed a retrospective cohort study of 8,661 patients diagnosed with loco-regional breast, prostate, or colorectal cancer. We examined survivorship care from days 366 to 1,095 following their cancer diagnosis. Our primary independent variable was "care density," a novel metric of the extent to which a patient's providers share patients with one another. Our outcome measures were health care utilization, quality metrics, and costs. RESULTS: In adjusted analyses, we found that patients with high care density--indicating high levels of patient-sharing among their providers--had significantly lower rates of hospitalization (OR 0.87, 95% CI 0.75-1.00) and higher odds of an eye examination for diabetes (OR 1.31, 95% CI 1.03-1.66) compared to patients with low care density. High care density was not associated with emergency department visits, avoidable outcomes, lipid profile following an angina diagnosis, or odds of glycosylated hemoglobin testing for diabetes. Patients with high care density had significantly lower total costs of care over 24 months (beta coefficient -$2,116, 95% CI -$3,107 to -$1,125) along with lower inpatient and outpatient costs. CONCLUSION: Cancer survivors treated by physicians who share more patients with one another tend to have some higher aspects of quality and lower cost care. IMPLICATIONS OF CANCER SURVIVORS: If validated, care density may be a useful indicator for monitoring care coordination among cancer survivors and potentially targeting interventions that seek to improve care delivery.

Measure once, cut twice--adding patient-reported outcome measures to the electronic health record for comparative effectiveness research.

OBJECTIVE: This article presents the current state of patient-reported outcome measures and explains new opportunities for leveraging the recent adoption of electronic health records to expand the application of patient-reported outcomes in both clinical care and comparative effectiveness research. STUDY DESIGN AND SETTING: Historic developments of patient-reported outcome, electronic health record, and comparative effectiveness research are analyzed in two dimensions: patient centeredness and digitization. We pose the question, "What needs to be standardized around the collection of patient-reported outcomes in electronic health records for comparative effectiveness research?" RESULTS: We identified three converging trends: the progression of patient-reported outcomes toward greater patient centeredness and electronic adaptation; the evolution of electronic health records into personalized and fully digitized solutions; and the shift toward patient-oriented comparative effectiveness research. Related to this convergence, we propose an architecture for patient-reported outcome standardization that could serve as a first step toward a more comprehensive integration of patient-reported outcomes with electronic health record for both practice and research. CONCLUSION: The science of patient-reported outcome measurement has matured sufficiently to be integrated routinely into electronic health records and other electronic health solutions to collect data on an ongoing basis for clinical care and comparative effectiveness research. Further efforts and ideally coordinated efforts from various stakeholders are needed to refine the details of the proposed framework for standardization.

Feasibility and value of PatientViewpoint: a web system for patient-reported outcomes assessment in clinical practice.

BACKGROUND: The PatientViewpoint website collects patient-reported outcomes and links them with the electronic health record to aid patient management. This pilot test evaluated PatientViewpoint's use, usefulness, and acceptability to patients and clinicians. METHODS: This was a single-arm prospective study that enrolled breast and prostate cancer patients undergoing treatment and the clinicians who managed them. Patients completed patient-reported outcomes every 2 weeks, and clinicians could access the results for patient visits. Scores that were poor relative to norms or substantially worse than the previous assessment were highlighted. After three on-study visits, we assessed patient and clinician perspectives on PatientViewpoint using close-ended and open-ended questions. RESULTS: Eleven out of 12 eligible clinicians (92%) and 52/76 eligible patients (68%) enrolled. Patients completed a median of 71% of assigned questionnaires; clinicians reported using the information for 79% of patients, most commonly as a source of additional information (51%). At the median, score reports identified three potential issues, of which 1 was discussed during the visit. Patients reported the system was easy to use (92%), useful (70%), aided recall of symptoms/side effects (72%), helped them feel more in control of their care (60%), improved discussions with their provider (49%), and improved care quality (39%). Patients and clinicians desired more information on score interpretation and minor adjustments to site navigation. CONCLUSIONS: These results support the feasibility and value of PatientViewpoint. An ongoing study is using a continuous quality improvement approach to further refine PatientViewpoint. Future studies will evaluate its impact on patient care and outcomes.

Implementing patient-reported outcomes assessment in clinical practice: a review of the options and considerations.

PURPOSE: While clinical care is frequently directed at making patients "feel better," patients' reports on their functioning and well-being (patient-reported outcomes [PROs]) are rarely collected in routine clinical practice. The International Society for Quality of Life Research (ISOQOL) has developed a User's Guide for Implementing Patient-Reported Outcomes Assessment in Clinical Practice. This paper summarizes the key issues from the User's Guide. METHODS: Using the literature, an ISOQOL team outlined considerations for using PROs in clinical practice; options for designing the intervention; and strengths, weaknesses, and resource requirements associated with each option. RESULTS: Implementing routine PRO assessment involves a number of methodological and practical decisions, including (1) identifying the goals for collecting PROs in clinical practice, (2) selecting the patients, setting, and timing of assessments, (3) determining which questionnaire(s) to use, (4) choosing a mode for administering and scoring the questionnaire, (5) designing processes for reporting results, (6) identifying aids to facilitate score interpretation, (7) developing strategies for responding to issues identified by the questionnaires, and (8) evaluating the impact of the PRO intervention on the practice. CONCLUSIONS: Integrating PROs in clinical practice has the potential to enhance patient-centered care. The online version of the User's Guide will be updated periodically.

How does initial treatment choice affect short-term and long-term costs for clinically localized prostate cancer?

BACKGROUND: Data regarding costs of prostate cancer treatment are scarce. This study investigates how initial treatment choice affects short-term and long-term costs. METHODS: This retrospective, longitudinal cohort study followed prostate-cancer cases diagnosed in 2000 for 5 years using the Surveillance, Epidemiology, and End Results (SEER)-Medicare database. Men age≥66 years, in Medicare fee for service, diagnosed with clinically localized prostate cancer in 2000 while residing in a SEER region, were matched to noncancer controls using age, sex, race, region, comorbidity, and survival. On the basis of treatment received during the first 9 months postdiagnosis, patients were assigned to watchful waiting, radiation, hormonal therapy, hormonal+radiation, and surgery (may have received other treatments). Incremental costs for prostate cancer were the difference in costs for prostate cancer cases versus matched controls. Costs were divided into initial treatment (months -1 to 12), long-term (each 12 months thereafter), and total (months -1 to 60). Sensitivity analyses excluded the last 12 months of life. RESULTS: A total of 13,769 prostate-cancer cases were matched to 13,769 noncancer controls. Watchful waiting had the lowest initial treatment ($4270) and 5-year total costs ($9130). Initial treatment costs were highest for hormonal+radiation ($17,474) and surgery ($15,197). At $26,896, 5-year total costs were highest for hormonal therapy only followed by hormonal+radiation ($25,097) and surgery ($19,214). After excluding the last 12 months of life, total costs were highest for hormonal+radiation ($23,488) and hormonal therapy ($23,199). CONCLUSIONS: Patterns of costs vary widely based on initial treatment. These data can inform patients and clinicians considering treatment options and policy makers interested in patterns of costs.

Needs assessments can identify scores on HRQOL questionnaires that represent problems for patients: an illustration with the Supportive Care Needs Survey and the QLQ-C30.

PURPOSE: A barrier to using HRQOL questionnaires for individual patient management is knowing what score represents a problem deserving attention. We explored using needs assessments to identify HRQOL scores associated with patient-reported unmet needs. METHODS: This cross-sectional study included 117 cancer patients (mean age 61 years; 51% men; 77% white) who completed the Supportive Care Needs Survey (SCNS) and EORTC QLQ-C30. SCNS scores were dichotomized as "no unmet need" versus "some unmet need" and served as an external criterion for identifying problem scores. We evaluated the discriminative ability of QLQ-C30 scores using receiver operating characteristic (ROC) analysis. Domains with an area under the ROC curve (AUC) >or= .70 were examined further to determine how well QLQ-C30 scores predicted presence/absence of unmet need. RESULTS: We found AUCs >or= .70 for 6 of 14 EORTC domains: physical, emotional, role, global QOL, pain, fatigue. All 6 domains had sensitivity >or= .85 and specificity >or= .50. EORTC domains that closely matched the content of SCNS item(s) were more likely to have AUCs >or= .70. The appropriate cut-off depends on the relative importance of false positives and false negatives. CONCLUSIONS: Needs assessments can identify HRQOL scores requiring clinicians' attention. Future research should confirm these findings using other HRQOL questionnaires and needs assessments.

Concordance of cancer patients' function, symptoms, and supportive care needs.

PURPOSE: Although patients' function, symptoms, and supportive care needs are obviously related, a better understanding of these relationships could improve patient management. METHODS: In this cross-sectional, observational study, 117 cancer patients completed the Supportive Care Needs Survey-34 and EORTC-QLQ-C30. Each symptom and function domain from the EORTC-QLQ-C30 was dichotomized (high vs. low) using a cut-off of reference sample mean scores. Each need domain was dichotomized using a cut-off of an average score representing an unmet need. We explored within-patient patterns of function, symptom, and need domains using latent class analysis. Based on these patterns, patients were categorized as high versus low function; high versus low symptom; and high versus low need. We examined the concordance between categorizations of patients' function, symptoms, and needs. RESULTS: The categorizations of function, symptoms, and needs were concordant for 66 patients (56%). Among patients with deficits in at least one area (n = 68), categorizations for 51 patients (75%) were discordant. CONCLUSIONS: About 50% of patients have similar classifications of their level of function, symptoms, and needs, but discordance was common among patients with deficits in at least one area, emphasizing the importance of assessing all of these outcomes as part of patient evaluations.

PatientViewpoint: a website for patient-reported outcomes assessment.

PURPOSE: To develop a prototype website to collect patient-reported outcomes in outpatient clinical oncology and link the data with the electronic medical record (EMR). METHODS: A multidisciplinary Research Network, including experts in outcomes research, clinical oncology, nursing, social work, information technology, EMRs, behavioral science, decision science, clinical trials, law, and a cancer survivor, was formed to design the prototype website. The Research Network developed the initial website specifications, elicited feedback from patients (n = 20) and clinicians (n = 7), constructed the website, and conducted usability testing (n = 10). RESULTS: Clinicians reported that the website could improve clinical practice if it was not burdensome and were most interested in tracking change over time. Patients were interested in using the website because of the potential to facilitate communication with their clinicians. Patients emphasized the importance of short and simple surveys and a user-friendly interface. The PatientView-oint website was designed to meet these specifications. Usability testing suggested that patients had few problems accessing and using the site. CONCLUSIONS: Preliminary reports from clinicians and patients suggest that a website to collect PROs and link them with the EMR could help improve the quality of cancer care. Further pilot-testing will evaluate the use, usefulness, and acceptability of PatientViewpoint.

Symptoms, supportive care needs, and function in cancer patients: how are they related?

AIMS: To explore the associations among symptoms, supportive care needs, and function. METHODS: One hundred and seventeen cancer patients completed the Supportive Care Needs Survey and EORTC-QLQ-C30 in a cross-sectional study. Associations among function (physical, role, emotional, cognitive, social), symptoms (fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea), and supportive care needs (physical and daily living, psychological, patient care and support, health system and information, sexual) were tested using multivariate item regression (MIR). We tested (1) function as the dependent variable with symptoms and supportive care needs as independent variables and (2) supportive care needs as the dependent variable with symptoms and function as independent variables. RESULTS: Worse fatigue, pain, and appetite loss were associated with worse function. Greater unmet physical and daily living needs were associated with worse physical, role, and cognitive function. Greater unmet psychological needs were associated with worse emotional and cognitive function. Worse sleep problems were associated with greater unmet needs. Better physical function was associated with fewer unmet physical and daily living needs, and better emotional function was associated with fewer unmet psychological, patient care and support, and health system and information needs. CONCLUSIONS: The results obtained with these models suggest several consistent relationships among symptoms, supportive care needs, and function.

Patient-reported outcomes in cancer: a review of recent research and policy initiatives.

There is growing recognition that patient-reported outcome (PRO) measures--encompassing, for example, health-related quality of life--can complement traditional biomedical outcome measures (eg, survival, disease-free survival) in conveying important information for cancer care decision making. This paper provides an integrated review and interpretation of how PROs have been defined, measured, and used in a range of recent cancer research and policy initiatives. We focus, in turn, on the role of PRO measurement in the evaluation and approval of cancer therapies, the assessment of cancer care in the community, patient-provider decision making in clinical oncology practice, and population surveillance of cancer patients and survivors. The paper concludes with a discussion of future challenges and opportunities in PRO measure development and application, given the advancing state of the science in cancer outcomes measurement and the evolving needs of cancer decision makers at all levels.

Asking the right questions: investigating needs assessments and health-related quality-of-life questionnaires for use in oncology clinical practice.

GOALS OF WORK: Questionnaires used in oncology practice for individual patient management need to address issues patients find important and want help with and issues cancer center health professionals can address. We investigated the item content from two health-related quality-of-life (HRQOL) questionnaires and two needs assessments for this purpose. PATIENTS AND METHODS: In this preliminary study, 61 cancer patients and 19 cancer center health professionals rated the item content from the EORTC-QLQ-C30, FACT-G, Supportive Care Needs Survey-34 (SCNS), and Kingston Needs Assessment--Cancer. Patients rated each item's importance and whether they wanted help with it; health professionals rated each item's importance and whether they felt able to help patients address it. Patients and health professionals also reported their overall questionnaire preference. MAIN RESULTS: Patients rated information about treatments (options, benefits, side effects) and care coordination as the most important issues and those for which they most wanted help from their health professionals. Health professionals rated pain and other symptom/side effect items as most important to patients and those for which they were most able to help. Findings were consistent across tumor type and treatment status. Patients had an overall preference for the SCNS. Health professionals had no clear questionnaire preference. CONCLUSIONS: This preliminary study suggests that the issues patients most want help with may not be the issues that health professionals feel most able to address. If these findings are confirmed in more representative samples, interventions may be needed to assist health professionals in managing cancer patients' HRQOL issues and needs.

Cancer outcomes measurement: Through the lens of the Medical Outcomes Trust framework.

BACKGROUND: In 2001, the U.S. National Cancer Institute established the Cancer Outcomes Measurement Working Group (COMWG) to evaluate and advance the state of the science in patient-reported outcome (PRO) measurement, with a focus on health-related quality of life (HRQOL). To guide its work, the COMWG adopted the revised Medical Outcomes Trust (MOT) attributes and review criteria for evaluating health status and quality-of-life instruments. OBJECTIVE: With the MOT attributes providing the organizing principle, this paper summarizes and draws inferences from key COMWG findings about the methodological soundness of HRQOL assessment in cancer and steps required to move the field forward. RESULTS AND CONCLUSIONS: Across a range of cancer research applications, especially clinical trials, a variety of generic, general cancer, and cancer site-specific measures of HRQOL have demonstrated adequate reliability, validity, responsiveness, feasibility, and cultural and language adaptation. Methodological challenges remain in the interpretability of HRQOL measures, though substantial progress has been made in defining a "minimum important difference" in scale scores. Much work remains in forging a stronger link between the conceptual model and measurement model in HRQOL instrumentation. Progress along all MOT attributes will likely accelerate with the growing application of modern psychometrics, particularly item response theory modeling, which provides the underpinnings for item banking and computer-adaptive assessment of HRQOL. Future research should emphasize prospectively designed studies to evaluate PRO measures within the MOT framework and in-depth investigations of the role of PRO measures in cancer decision making at all levels.