Development and acceptability of PETS-Now, an electronic point-of-care tool to monitor treatment burden in patients with multiple chronic conditions: a multi-method study.

BACKGROUND: The aim of this study was to develop a web-based tool for patients with multiple chronic conditions (MCC) to communicate concerns about treatment burden to their healthcare providers. METHODS: Patients and providers from primary-care clinics participated. We conducted focus groups to identify content for a prototype clinical tool to screen for treatment burden by reviewing domains and items from a previously validated measure, the Patient Experience with Treatment and Self-management (PETS). Following review of the prototype, a quasi-experimental pilot study determined acceptability of using the tool in clinical practice. The study protocol was modified to accommodate limitations due to the Covid-19 pandemic. RESULTS: Fifteen patients with MCC and 18 providers participated in focus groups to review existing PETS content. The pilot tool (named PETS-Now) consisted of eight domains (Living Healthy, Health Costs, Monitoring Health, Medicine, Personal Relationships, Getting Healthcare, Health Information, and Medical Equipment) with each domain represented by a checklist of potential concerns. Administrative burden was minimized by limiting patients to selection of one domain. To test acceptability, 17 primary-care providers first saw 92 patients under standard care (control) conditions followed by another 90 patients using the PETS-Now tool (intervention). Each treatment burden domain was selected at least once by patients in the intervention. No significant differences were observed in overall care quality between patients in the control and intervention conditions with mean care quality rated high in both groups (9.3 and 9.2, respectively, out of 10). There were no differences in provider impressions of patient encounters under the two conditions with providers reporting that patient concerns were addressed in 95% of the visits in both conditions. Most intervention group patients (94%) found that the PETS-Now was easy to use and helped focus the conversation with the provider on their biggest concern (98%). Most providers (81%) felt they had learned something new about the patient from the PETS-Now. CONCLUSION: The PETS-Now holds promise for quickly screening and monitoring treatment burden in people with MCC and may provide information for care planning. While acceptable to patients and clinicians, integration of information into the electronic medical record should be prioritized.

Effects of patient-reported outcome assessment order.

BACKGROUND: In clinical trials and clinical practice, patient-reported outcomes are almost always assessed using multiple patient-reported outcome measures at the same time. This raises concerns about whether patient responses are affected by the order in which the patient-reported outcome measures are administered. METHODS: This questionnaire-based study of order effects included adult cancer patients from five cancer centers. Patients were randomly assigned to complete questionnaires via paper booklets, interactive voice response system, or tablet web survey. Linear Analogue Self-Assessment, Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events, and Patient-Reported Outcomes Measurement Information System assessment tools were each used to measure general health, physical function, social function, emotional distress/anxiety, emotional distress/depression, fatigue, sleep, and pain. The order in which the three tools, and domains within tools, were presented to patients was randomized. Rates of missing data, scale scores, and Cronbach's alpha coefficients were compared by the order in which they were assessed. Analyses included Cochran-Armitage trend tests and mixed models adjusted for performance score, age, sex, cancer type, and curative intent. RESULTS: A total of 1830 patients provided baseline patient-reported outcome assessments. There were no significant trends in rates of missing values by whether a scale was assessed earlier or later. The largest order effect for scale scores was due to a large mean score at one assessment time point. The largest difference in Cronbach's alpha between the versions for the Patient-Reported Outcomes Measurement Information System scales was 0.106. CONCLUSION: The well-being of a cancer patient has many different aspects such as pain, fatigue, depression, and anxiety. These are assessed using a variety of surveys often collected at the same time. This study shows that the order in which the different aspects are collected from the patient is not important.

Improving the Delivery of Function-Directed Care During Acute Hospitalizations: Methods to Develop and Validate the Functional Assessment in Acute Care Multidimensional Computerized Adaptive Test (FAMCAT).

OBJECTIVE: To (1) develop a patient-reported, multidomain functional assessment tool focused on medically ill patients in acute care settings; (2) characterize the measure's psychometric performance; and (3) establish clinically actionable score strata that link to easily implemented mobility preservation plans. DESIGN: This article describes the approach that our team pursued to develop and characterize this tool, the Functional Assessment in Acute Care Multidimensional Computer Adaptive Test (FAMCAT). Development involved a multistep process that included (1) expanding and refining existing item banks to optimize their salience for hospitalized patients; (2) administering candidate items to a calibration cohort; (3) estimating multidimensional item response theory models; (4) calibrating the item banks; (5) evaluating potential multidimensional computerized adaptive testing (MCAT) enhancements; (6) parameterizing the MCAT; (7) administering it to patients in a validation cohort; and (8) estimating its predictive and psychometric characteristics. SETTING: A large (2000-bed) Midwestern Medical Center. PARTICIPANTS: The overall sample included 4495 adults (2341 in a calibration cohort, 2154 in a validation cohort) who were admitted either to medical services with at least 1 chronic condition or to surgical/medical services if they required readmission after a hospitalization for surgery (N=4495). INTERVENTION: Not applicable. MAIN OUTCOME MEASURES: Not applicable. RESULTS: The FAMCAT is an instrument designed to permit the efficient, precise, low-burden, multidomain functional assessment of hospitalized patients. We tried to optimize the FAMCAT's efficiency and precision, as well as its ability to perform multiple assessments during a hospital stay, by applying cutting edge methods such as the adaptive measure of change (AMC), differential item functioning computerized adaptive testing, and integration of collateral test-taking information, particularly item response times. Evaluation of these candidate methods suggested that all may enhance MCAT performance, but none were integrated into initial MCAT parameterization. CONCLUSIONS: The FAMCAT has the potential to address a longstanding need for structured, frequent, and accurate functional assessment among patients hospitalized with medical diagnoses and complications of surgery.

Validation of a Short Form for Health Literacy Assessment Using Talking Touchscreen Technology.

BACKGROUND: Health literacy is an area of growing research and clinical interest, necessitating short, accurate measures of this complex construct. Health Literacy Assessment Using Talking Touchscreen Technology (Health LiTT) measures prose, document, and quantitative literacy by self-administration on a touchscreen computer. OBJECTIVE: The objective of this study was to assess the validity of a short form of Health LiTT and to identify a meaningful cutoff score for adequate health literacy. METHODS: A subsample of 137 participants from the Literacy and Cognitive Function among Older Adults study completed a 10-item Health LiTT short form and three interviewer-administered health literacy measures: Test of Functional Health Literacy in Adults (TOFHLA), Rapid Estimate of Adult Literacy in Medicine (REALM), and Newest Vital Sign (NVS). Convergent validity was assessed by correlating scores for all measures, and known-groups validity was assessed by comparing mean Health LITT scores across TOFHLA levels (inadequate, marginal, adequate). Internal consistency reliability was estimated with Cronbach's alpha. A cutoff score for adequate health literacy was established using the TOFHLA cutoff for adequate versus inadequate/marginal health literacy. KEY RESULTS: Spearman correlations between Health LiTT scores and total TOFHLA, REALM, and NVS scores were 0.65, 0.69, and 0.56, respectively (all p < .001). Mean Health LiTT scores were significantly and meaningfully different across inadequate (40.4), marginal (50.1), and adequate (57.1) TOFHLA categories (F = 60.6; p < .001). Cronbach's alpha for the Health LiTT short form was .73. A cutoff score of 55 on Health LiTT showed acceptable sensitivity and specificity to identify adequate health literacy. CONCLUSIONS: This 10-item Health LiTT short form demonstrated excellent convergent and known-groups validity and acceptable internal consistency reliability in older adults. The established cutoff also showed excellent sensitivity and specificity. Validation of other custom Health LiTT short forms with varying items from the bank and computer adaptive test-generated Health LiTT scores is ongoing. [HLRP: Health Literacy Research and Practice. 2020;4(4):e200-e207.] PLAIN LANGUAGE SUMMARY: This article provides evidence of the need for and psychometric properties of a valid and reliable short form of the flexible, technologically advanced Health Literacy Assessment Using Talking Touchscreen Technology measure, as well as a cutoff score to note adequate versus marginal/inadequate health literacy.

Association between an individual housing-based socioeconomic index and inconsistent self-reporting of health conditions: a prospective cohort study in the Mayo Clinic Biobank.

OBJECTIVE: Using surveys to collect self-reported information on health and disease is commonly used in clinical practice and epidemiological research. However, the inconsistency of self-reported information collected longitudinally in repeated surveys is not well investigated. We aimed to investigate whether a socioeconomic status based on current housing characteristics, HOUsing-based SocioEconomic Status (HOUSES) index linking current address information to real estate property data, is associated with inconsistent self-reporting. STUDY SETTING AND PARTICIPANTS: We performed a prospective cohort study using the Mayo Clinic Biobank (MCB) participants who resided in Olmsted County, Minnesota, USA, at the time of enrolment between 2009 and 2013, and were invited for a 4-year follow-up survey (n=11 717). PRIMARY AND SECONDARY OUTCOME MEASURES: Using repeated survey data collected at the baseline and 4 years later, the primary outcome was the inconsistency in survey results when reporting prevalent diseases, defined by reporting to have 'ever' been diagnosed with a given disease in the baseline survey but reported 'never' in the follow-up survey. Secondary outcome was the response rate for the 4-year follow-up survey. RESULTS: Among the MCB participants invited for the 4-year follow-up survey, 8508/11 717 (73%) responded to the survey. Forty-three per cent had at least one inconsistent self-reported disease. Lower HOUSES was associated with higher inconsistency rates, and the association remained significant after pertinent characteristics such as age and perceived general health (OR=1.46; 95% CI 1.17 to 1.84 for the lowest compared with the highest HOUSES decile). HOUSES was also associated with lower response rate for the follow-up survey (56% vs 77% for the lowest vs the highest HOUSES decile). CONCLUSION: This study demonstrates the importance of using the HOUSES index that reflects current SES when using self-reporting through repeated surveys, as the HOUSES index at baseline survey was inversely associated with inconsistent self-report and the response rate for the follow-up survey.

Illness Understanding of Oncology Patients in a Community-Based Cancer Institute.

PURPOSE: Several studies have demonstrated that patients have a poor understanding of prognosis, survival, and effectiveness of chemotherapy, particularly in the setting of advanced cancer. This study examines oncology patients' understanding of their illness based on accurate reporting of stage at diagnosis and knowledge of cancer status (ie, free of cancer or in remission v active disease). MATERIALS AND METHODS: Two hundred eight patients with cancer previously treated at our large community-based cancer institute participated in the Consumer-Based Cancer Care Value Index field survey. Electronic medical record documentation of stage at diagnosis and cancer status was compared with patients' self-reported responses. Concordance of responses and variables influencing discordance were evaluated. RESULTS: In 51.0% of patients, self-reported cancer stage matched the abstracted stage, with the highest concordance in patients with advanced cancer (72%) versus patients with stage I to III disease (36.4% to 61.5%). Unexpectedly, discordance was lower among patients with advanced cancer compared with patients with stage I to III cancer ( P = .0528). Patients who were concordant for cancer stage at diagnosis were significantly more likely to be female ( P = .001), be younger than age 65 years ( P = .01), have an income > $60,000 ( P = .03), and have more education ( P = .02). In 64.4% of patients, self-reported cancer status (ie, free of cancer or in remission v active disease) matched the abstracted status. Nearly 30% of patients were not sure about their status, even when they were free of cancer or in remission. CONCLUSION: Our findings confirm that more than one quarter of patients with advanced cancer have poor illness understanding and highlight that an even greater number of patients with early stage I to III cancer have poor illness understanding. These observations highlight the need to improve illness understanding for patients across the entire cancer continuum.

Achieving a 5-star rating: Analysis of Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scores among patients undergoing elective colorectal operations.

BACKGROUND: Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) is a publicly reported survey of patients' hospital experience. METHODS: All inpatient, elective colorectal resections with completed HCAHPS surveys at a single institution between June 2012 and April 2015 were identified. HCAHPS measures were analyzed according to published methodologies. Univariate logistic regression evaluated associations of various HCAHPS measures with age, sex, ostomy, approach, diagnosis, and prolonged length of stay (PLOS; ≥7 days). Key driver analysis demonstrated associations between the individual HCAHPS measures and the global hospital rating measure. RESULTS: We identified 755 patients. Younger age, inflammatory bowel disease, open approach, ostomy construction, and PLOS were associated with low quality of pain management. Patients with inflammatory bowel disease, open approach, and PLOS had a low overall star score (all P < .05). Care transitions and communication about medications received low scores but were associated highly with the global hospital rating measure. CONCLUSION: Efforts aimed at improving pain management among patients with colorectal resection should focus on patients with inflammatory bowel disease, open operations, ostomies, and PLOS. Improving care transitions and communication about medications are important targets for improvement to increase the overall hospital score. Considering the importance of improving patient-centered outcomes, we suggest that all institutions utilize their existing HCAHPS data in this manner.

Effect of Hospital Case Mix on the Hospital Consumer Assessment of Healthcare Providers and Systems Star Scores: Are All Stars the Same?

OBJECTIVE: We aimed to evaluate variations in patient experience measures across different surgical specialties and to assess the impact of further case-mix adjustment. BACKGROUND: Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) is a publicly reported survey of patients' hospital experiences that directly influence Medicare reimbursement. METHODS: All adult surgical inpatients meeting criteria for HCAHPS sampling from 2013 to 2014 at a single academic center were identified. HCAHPS measures were analyzed according to published top-box and Star-rating methodologies, and were dichotomized ("high" vs "low"). Multivariable logistic regression was used to identify independent associations of high patient scores on various HCAHPS measures with specialty, diagnosis-related group complexity, cancer diagnosis, sex, and emergency admission after adjusting for HCAHPS case-mix adjusters (education, overall health status, language, and age). RESULTS: We identified 36,551 eligible patients, of which 30.8% (n = 11,273) completed HCAHPS. Women [odds ratio (OR) 0.78, 95% confidence interval (CI) 0.72-0.85, P < 0.001], complex cases (OR 0.90, 95% CI 0.82-0.99, P = 0.02), and emergency admissions (OR 0.67, 95% CI 0.55-0.82, P < 0.001) had lesser Star scores on adjusted analysis, whereas patients with a cancer diagnosis had greater Star scores (OR 1.15, 95% CI 1.03-1.29, P = 0.01). Using general surgery as the reference, the Star scores varied significantly across 12 specialties (range OR 0.65 for plastics to 1.29 for transplant surgery). Patient responses to individual composite scores (pain, care transition, physician, and nurse) varied by specialty. CONCLUSIONS: HCAHPS case-mix adjustment does not include adjustment for specialty or diagnosis, which may result in artificially lower scores for centers that provide a high level of complex care. Further research is needed to ensure that the HCAHPS is an unbiased comparison tool.

The Minimal Clinically Important Difference in Vestibular Schwannoma Quality-of-Life Assessment: An Important Step beyond P < .05.

OBJECTIVE: Several studies have demonstrated small but statistically significant differences in quality-of-life (QOL) scores among vestibular schwannoma (VS) treatment modalities. However, does a several-point difference on a 100-point scale really matter? The minimal clinically important difference (MCID)-defined as the smallest difference in scores that patients perceive as important and that could lead to a change in management-was developed to answer this important question. While the MCID has been determined for QOL measures used in other diseases, it remains undefined in the VS literature. STUDY DESIGN: Distribution- and anchor-based techniques were utilized to define the MCID for the Penn Acoustic Neuroma Quality of Life (PANQOL) and 36-Item Short Form Health Survey (SF-36). SETTING: Two academic referral centers. PATIENTS: Patients with VS (N = 538). INTERVENTION: Cross-sectional postal survey. MAIN OUTCOME MEASURES: MCID for PANQOL domains and total score and SF-36 Physical and Mental Health Component Summary scores. RESULTS: The MCID (median, interquartile range) for the PANQOL total score was 11 points (10-12); the MCIDs for individual domains were as follows: hearing, 6 (5-8); balance, 16 (14-19); facial, 10 (no interquartile range); pain, 11 (10-13); energy, 13 (10-17); anxiety, 11 (5-22); and general, 15 (11-19). The MCID was 7 points (6-11) for the SF-36 Mental Health Component Summary score and 8 points (6-10) for the Physical Health Component Summary score. CONCLUSIONS: The MCIDs determined in the current study generally exceed differences reported in previous prospective studies, in which conclusions about QOL benefit (or harm) among VS treatment modalities were based on statistical significance alone. Moving forward, these MCIDs should be considered when interpreting results of VS QOL studies.

The association between health literacy and indicators of cognitive impairment in a diverse sample of primary care patients.

OBJECTIVES: To confirm the association of health literacy scores as measured by Health Literacy Assessment Using Talking Touchscreen Technology (Health LiTT) with cognitive ability and education. To determine whether this association differs by cognitive task. METHODS: Cognitive impairment was measured using the Mini-Cog, which combines a delayed word recall task (WRT) and a clock drawing task (CDT) to yield an overall classification of normal versus cognitively impaired. Participants were recruited from primary care clinics that provide care to underserved patients. RESULTS: Participants (n=574) were predominantly non-Hispanic black (67%) with a mean age of 46 years, 50% did not have health insurance, 56% had a high school education or less and 21% screened positive for cognitive impairment. Overall cognitive ability and education were significantly associated with health literacy after adjusting for other variables, including race/ethnicity and physical health. We observed a stronger association between the CDT and health literacy than between the WRT and health literacy. CONCLUSION: By confirming hypothesized associations, this study provides additional support of the validity of Health LiTT. PRACTICE IMPLICATIONS: Health LiTT is a reliable and valid tool that researchers and clinicians can use to identify individuals who might have difficulty understanding health information.

The Functional Assessment of Cancer Therapy - General (FACT-G) is valid for monitoring quality of life in patients with non-Hodgkin lymphoma.

Quality of life (QoL) is an important outcome in patients with non-Hodgkin lymphoma (NHL). We assessed the validity of administering the Functional Assessment of Cancer Therapy - General (FACT-G) at 12-month intervals over 3 years in a longitudinal study of 611 prospectively enrolled, newly diagnosed patients with NHL. We evaluated corrected item-total correlation and percent missing to identify items that may be less useful in certain NHL patient subgroups. The FACT-G subscales and total score demonstrated good internal consistency reliability, convergent validity and known-groups validity. Most scores also demonstrated good responsiveness to change. Questions that could be problematic included GE3 (losing hope) and GP2 (nausea) for patients in remission, and GP5 (bothered by side effects) for patients being observed. Overall, the FACT-G was a valid measure for monitoring QoL over time in patients with NHL. However, sensitivity analyses based on subscale scoring that excludes potentially problematic items may be warranted.

Health literacy assessment using talking touchscreen technology (Health LiTT): a new item response theory-based measure of health literacy.

The importance of health literacy has grown considerably among researchers, clinicians, patients, and policymakers. Better instruments and measurement strategies are needed. Our objective was to develop a new health literacy instrument using novel health information technology and modern psychometrics. We designed Health LiTT as a self-administered multimedia touchscreen test based on item response theory (IRT) principles. We enrolled a diverse group of 619 English-speaking, primary care patients in clinics for underserved patients. We tested three item types (prose, document, quantitative) that worked well together to reliably measure a single dimension of health literacy. The Health LiTT score meets psychometric standards (reliability of 0.90 or higher) for measurement of individual respondents in the low to middle range. Mean Health LiTT scores were associated with age, race/ethnicity, education, income, and prior computer use (p < .05). We created an IRT-calibrated item bank of 82 items. Standard setting needs to be performed to classify and map items onto the construct and to identify measurement gaps. We are incorporating Health LiTT into an existing online research management tool. This will enable administration of Health LiTT on the same touchscreen used for other patient-reported outcomes, as well as real-time scoring and reporting of health literacy scores.

Acceptability of the talking touchscreen for health literacy assessment.

Self-administration of a multimedia health literacy measure in clinic settings is a novel concept. Demonstrated ease of use and acceptability will help predicate the future value of this strategy. We previously demonstrated the acceptability of a "Talking Touchscreen" for health status assessment. For this study, we adapted the touchscreen for self-administration of a new health literacy measure. Primary care patients (n = 610) in clinics for underserved populations completed health status and health literacy questions on the Talking Touchscreen and participated in an interview. Participants were 51% women, 10% age 60+, 67% African American, 18% without a high school education, and 14% without any prior computer experience. The majority (93%) had no difficulty using the touchscreen, including those who were computer-naive (87%). Most rated the screen design as very good or excellent (72%), including computer-naive patients (71%) and older patients (75%). Acceptability of the touchscreen did not differ by health literacy level. The Talking Touchscreen was easy to use and acceptable for self-administration of a new health literacy measure. Self-administration should reduce staff burden and costs, interview bias, and feelings of embarrassment by those with lower literacy. Tools like the Talking Touchscreen may increase exposure of underserved populations to new technologies.

Providing contraception for women taking potentially teratogenic medications: a survey of internal medicine physicians' knowledge, attitudes and barriers.

BACKGROUND: The majority of women prescribed category D or X medications may not receive adequate contraceptive counseling or a reliable contraceptive method. Physicians who prescribe potentially teratogenic medications have a responsibility to provide women with contraceptive counseling, a method of highly-effective contraception, or both. OBJECTIVE: Investigate the knowledge, beliefs and barriers of primary care physicians toward providing adequate contraception to women taking potential teratogens. DESIGN & PARTICIPANTS: Self-administered confidential survey of primary care internal medicine physicians at an urban, academic medical center. MEASUREMENTS: Knowledge of potential teratogenic medications and contraceptive failure rates was assessed. Participants' beliefs about adequacy of their medical education, practice limitations and attitudes toward improving provision of contraception to women on potential teratogens were assessed. RESULTS: One hundred and ten physicians responded (57.3%). Nearly two-thirds (62.3%) of participants had cared for reproductive aged women taking category D or X medications in the past year. The mean percent of correctly identified category D or X medications was 58.4% (SD 22.1%). The mean percent correct for knowledge of published contraceptive failure rates was 64.6% (SD 23.1%). Most respondents (87.6%) felt it is the responsibility of primary care physicians to provide contraception. Time constraints were reported to be somewhat or very limiting by 61.3% and over half felt medical school (63.2%) or residency (58.1%) inadequately prepared them to prescribe or counsel about contraceptives. CONCLUSIONS: Primary care physicians commonly encounter reproductive age women taking category D or X medications, but may lack sufficient knowledge and time to counsel about potential teratogens and contraception to prevent fetal exposure to these drugs.

Bilingual health literacy assessment using the Talking Touchscreen/la Pantalla Parlanchina: Development and pilot testing.

OBJECTIVE: Current health literacy measures are too long, imprecise, or have questionable equivalence of English and Spanish versions. The purpose of this paper is to describe the development and pilot testing of a new bilingual computer-based health literacy assessment tool. METHODS: We analyzed literacy data from three large studies. Using a working definition of health literacy, we developed new prose, document and quantitative items in English and Spanish. Items were pilot tested on 97 English- and 134 Spanish-speaking participants to assess item difficulty. RESULTS: Items covered topics relevant to primary care patients and providers. English- and Spanish-speaking participants understood the tasks involved in answering each type of question. The English Talking Touchscreen was easy to use and the English and Spanish items provided good coverage of the difficulty continuum. CONCLUSION: Qualitative and quantitative results provided useful information on computer acceptability and initial item difficulty. After the items have been administered on the Talking Touchscreen (la Pantalla Parlanchina) to 600 English-speaking (and 600 Spanish-speaking) primary care patients, we will develop a computer adaptive test. PRACTICE IMPLICATIONS: This health literacy tool will enable clinicians and researchers to more precisely determine the level at which low health literacy adversely affects health and healthcare utilization.

Future trends in patient-reported outcomes assessment for patients with advanced-stage lung cancer receiving targeted therapy.

Recent advances in cancer cell biology have led to the development of therapeutic agents that target pathways critical to the development and progression of disease. These so-called "targeted therapies" might offer patients a more tolerable alternative to traditional systemic chemotherapy that often achieves therapeutic benefit at the cost of debilitating side effects. Several targeted agents have been recently tested in clinical trials of advanced-stage lung cancer. As interest in these therapies grows, an understanding of their impact on the patient's well-being will be important. Patient-reported outcome measures such as formal assessments of health-related quality of life and disease symptoms provide a useful means for addressing the impact of therapy from the perspective of the patient. We summarize the most commonly used measures of health-related quality of life in clinical trials of advanced-stage lung cancer. Although existing measurement systems do provide adequate coverage of many important patient-related outcome issues, the advent of targeted therapies in advanced-stage lung cancer does expose several measurement gaps. We highlight some of these gaps by reviewing a representative sample of recently conducted clinical trials of targeted lung cancer therapy and offer insight as to how these gaps can be filled. We also briefly discuss a set of issues unique to patients receiving targeted therapy (eg, perceptions of treatment efficacy, treatment compliance, patient satisfaction, and treatment convenience) and consider a few methodologic concerns unique to patients with advanced cancer.

Application of robust statistical methods for sensitivity analysis of health-related quality of life outcomes.

BACKGROUND: Researchers often use conventional parametric procedures to test hypotheses of health-related quality of life (HRQL) mean equality across patient groups. However, these techniques are sensitive to the presence of skewed distributions and unequal group variances, which may characterize many HRQL measures. PURPOSE: To conduct a sensitivity analysis of conventional and robust approaches to test hypotheses of mean equality on HRQL measures for hematopoietic stem cell transplantation survivors and a healthy comparison group. METHODS: The methods applied were the conventional parametric procedure of least-squares analysis of variance applied to the raw scores, the conventional parametric procedure applied to transformed data, and a robust approximate degrees of freedom parametric procedure utilizing trimmed means and Winsorized variances. RESULTS: The choice of analysis method affected the conclusions about the null hypothesis of mean equality. More commonly observed, however, was a substantial difference in the value of the F-statistic and standard errors which was particularly evident in the measures with greater degrees of skewness and heterogeneity of variances. CONCLUSIONS: Robust statistical tests should be incorporated into sensitivity analyses when analyzing HRQL data.

Patients' perceptions of quality of care for colorectal cancer by race, ethnicity, and language.

PURPOSE: To identify opportunities for improving care, we evaluated patients' perceptions of the quality of their cancer care by race, ethnicity, and language. PATIENTS AND METHODS: We surveyed a population-based cohort of 1,067 patients with colorectal cancer in northern California approximately 9 months after diagnosis. Adjusting for clinical and demographic factors, mean problem scores were analyzed on a 100-point scale for six domains of care. RESULTS: Mean problem scores were highest for health information (47.8), followed by treatment information (32.3), psychosocial care (31.7), coordination of care (21.3), confidence in providers (13.1), and access to cancer care (12.7). In adjusted comparisons with white patients, African American patients reported more problems with coordination of care (difference, 9.8; P < .001), psychosocial care (difference, 7.2; P = .03), access to care (difference, 6.6; P = .03), and health information (difference, 12.5; P < .001). Asian/Pacific Islander patients reported more problems than did white patients with coordination of care (difference, 13.2; P < .001), access to care (difference, 15.5; P < .001), and health information (difference, 12.6; P = .004). Hispanic patients tended to report more problems with coordination of care (difference, 4.4; P = .06), access to care (difference, 5.8; P = .08), and treatment information (difference, 7.0; P = .06). Non-English-speaking white patients reported more problems than other white patients with coordination of care (difference, 21.9; P < .001), psychosocial care (difference, 16.1; P = .009), access to care (difference, 19.8; P = .003), and treatment information (difference, 17.8; P = .002). Non-English-speaking Hispanic patients reported more problems than other Hispanic patients with confidence in providers (difference, 16.9; P = .01). CONCLUSION: Efforts to improve patients' experiences with cancer care should address disparities by race, ethnicity, and language, particularly in coordination of care, access to care, and the provision of relevant information.

Using multiple anchor- and distribution-based estimates to evaluate clinically meaningful change on the Functional Assessment of Cancer Therapy-Biologic Response Modifiers (FACT-BRM) instrument.

OBJECTIVE: The interpretation of health-related quality of life (HRQL) data from clinical trials can be enhanced by understanding the degree of change in HRQL scores that is considered meaningful. Our objectives were to combine distribution-based and two anchor-based approaches to identify minimally important differences (MIDs) for the 27-item Trial Outcome Index (TOI), the seven-item Social Well-Being (SWB) subscale, and the six-item Emotional Well-being (EWB) subscale from the Functional Assessment of Cancer Therapy-Biological Response Modifiers (FACT-BRM) instrument. METHODS: Distribution-based MIDs were based on the standard error of measurement. Anchor-based approaches utilized patient-reported global rating of change (GRC) and change in physician-reported performance status rating (PSR). Correlations and weighted kappa statistics were used to assess association and agreement between the two anchors. FACT-BRM changes were evaluated for three time periods: baseline to month 1, month 2 to month 3, and month 5 to month 6. RESULTS: Association between GRC and change in PSR was poor. Correlation between the anchors and HRQL change scores was largest at month 1 and decreased through month 6. Combining results from all approaches, the MIDs identified were 5-8 points for the TOI, 2 points for the SWB subscale, and 2-3 points for the EWB subscale. CONCLUSIONS: We combined patient-reported estimates, physician-reported estimates, and distribution-based estimates to derive MIDs for HRQL outcomes from the FACT-BRM. These results will enable interpretation of treatment group effects in a clinical trial setting, and they can be used to estimate sample size or power when designing future studies.

Validation of the Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI).

We assessed the reliability, validity, and responsiveness to change of the 6-item Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI) in a sample of 615 metastatic breast cancer patients. The FBSI is a brief, clinically relevant, and psychometrically sound instrument that can be used to measure symptoms in patients with breast cancer.