Kathryn E. Flynn

Effects of exercise training on health status in patients with chronic heart failure: HF-ACTION randomized controlled trial.

CONTEXT Findings from previous studies of the effects of exercise training on patient-reported health status have been inconsistent. OBJECTIVE To test the effects of exercise training on health status among patients with heart failure. DESIGN, SETTING, AND PATIENTS Multicenter, randomized controlled trial among 2331 medically stable outpatients with heart failure with left ventricular ejection fraction of 35% or less. Patients were randomized from April 2003 through February 2007. INTERVENTIONS Usual care plus aerobic exercise training (n = 1172), consisting of 36 supervised sessions followed by home-based training, vs usual care alone (n = 1159). Randomization was stratified by heart failure etiology, which was a covariate in all models. MAIN OUTCOME MEASURES Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary scale and key subscales at baseline, every 3 months for 12 months, and annually thereafter for up to 4 years. The KCCQ is scored from 0 to 100 with higher scores corresponding to better health status. Treatment group effects were estimated using linear mixed models according to the intention-to-treat principle. RESULTS Median follow-up was 2.5 years. At 3 months, usual care plus exercise training led to greater improvement in the KCCQ overall summary score (mean, 5.21; 95% confidence interval, 4.42 to 6.00) compared with usual care alone (3.28; 95% confidence interval, 2.48 to 4.09). The additional 1.93-point increase (95% confidence interval, 0.84 to 3.01) in the exercise training group was statistically significant (P < .001). After 3 months, there were no further significant changes in KCCQ score for either group (P = .85 for the difference between slopes), resulting in a sustained, greater improvement overall for the exercise group (P < .001). Results were similar on the KCCQ subscales, and no subgroup interactions were detected. CONCLUSIONS Exercise training conferred modest but statistically significant improvements in self-reported health status compared with usual care without training. Improvements occurred early and persisted over time. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00047437.

Standardizing patient-reported outcomes assessment in cancer clinical trials: a patient-reported outcomes measurement information system initiative.

Patient-reported outcomes (PROs), such as symptom scales or more broad-based health-related quality-of-life measures, play an important role in oncology clinical trials. They frequently are used to help evaluate cancer treatments, as well as for supportive and palliative oncology care. To be most beneficial, these PROs must be relevant to patients and clinicians, valid, and easily understood and interpreted. The Patient-Reported Outcomes Measurement Information System (PROMIS) Network, part of the National Institutes of Health Roadmap Initiative, aims to improve appreciably how PROs are selected and assessed in clinical research, including clinical trials. PROMIS is establishing a publicly available resource of standardized, accurate, and efficient PRO measures of major self-reported health domains (eg, pain, fatigue, emotional distress, physical function, social function) that are relevant across chronic illnesses including cancer. PROMIS is also developing measures of self-reported health domains specifically targeted to cancer, such as sleep/wake function, sexual function, cognitive function, and the psychosocial impacts of the illness experience (ie, stress response and coping; shifts in self-concept, social interactions, and spirituality). We outline the qualitative and quantitative methods by which PROMIS measures are being developed and adapted for use in clinical oncology research. At the core of this activity is the formation and application of item banks using item response theory modeling. We also present our work in the fatigue domain, including a short-form measure, as a sample of PROMIS methodology and work to date. Plans for future validation and application of PROMIS measures are discussed.

When do older adults turn to the internet for health information? Findings from the Wisconsin Longitudinal Study.

AbstractBACKGROUND: Understanding how and when patients use nonphysician sources of health information is important to facilitate shared decision making within provider outpatient visits. However, little is known about which older adults seek health information on the internet or when. OBJECTIVE: To determine how patient characteristics are related to seeking health information online and to the timing of these searches in relation to doctor visits. PARTICIPANTS: Six thousand two hundred and seventy-nine respondents (aged 63 to 66 years) who completed the 2004 round of phone and mail surveys (70% response) as part of the Wisconsin Longitudinal Study Graduate Sample. MEASUREMENTS: Self-reported use of the internet to search for health information and timing of use. RESULTS: One-third of respondents had searched online for information about their own health or health care. Half of these searched for health information unrelated to their last doctor visit, while 1/3 searched after a visit, and 1/6 searched before. Among respondents with internet access at home or work, years of education (odds ratio [OR]=1.09, confidence interval [CI]=1.06 to 1.13) and openness-to-experience (OR=1.26, CI=1.16 to 1.36) were positively associated with searching online for health information irrespective of timing in relation to doctor visits. Compared with those who had never sought health information online, sicker individuals (especially those with cancer, OR=1.51, CI=1.14 to 1.99) were more likely to seek information online after a doctor visit. Attitudinal and personality factors were related to seeking health information online before or unrelated to a visit. CONCLUSIONS: There are important differences in the timing of online health information searches by psychological and health characteristics among older adults with internet access.

Sleep–wake functioning along the cancer continuum: focus group results from the Patient‐Reported Outcomes Measurement Information System (PROMIS®)

Objective: Cancer and its treatments disturb sleep–wake functioning; however, there is little information available on the characteristics and consequences of sleep problems associated with cancer. As part of an effort to improve measurement of sleep–wake functioning, we explored the scope of difficulties with sleep in a diverse group of patients diagnosed with cancer.

National survey of hospital strategies to reduce heart failure readmissions findings from the get with the guidelines-heart failure registry

Background— Reducing 30-day heart failure readmission rates is a national priority. Yet, little is known about how hospitals address the problem and whether hospital-based processes of care are associated with reductions in readmission rates. Methods and Results— We surveyed 100 randomly selected hospitals participating in the Get With the Guidelines-Heart Failure quality improvement program regarding common processes of care aimed at reducing readmissions. We grouped processes into 3 domains (ie, inpatient care, discharge and transitional care, and general quality improvement) and scored hospitals on the basis of survey responses using processes selected a priori. We used linear regression to examine associations between these domain scores and 30-day risk-standardized readmission rates. Of the 100 participating sites, 28% were academic centers and 64% were community hospitals. The median readmission rate among participating sites (24.0%; 95% CI, 22.6%–25.7%) was comparable with the national average (24.6%; 23.5–25.9). Sites varied substantially in care processes used for inpatient care, education, discharge process, care transitions, and quality improvement. Overall, neither inpatient care nor general quality improvement domains were associated with 30-day readmission rates. Hospitals in the lowest readmission rate quartile had modestly higher discharge and transitional care domain scores ( P =0.03). Conclusions— A variety of strategies are used by hospitals in an attempt to improve 30-day readmission rates for patients hospitalized with heart failure. Although more complete discharge and transitional care processes may be modestly associated with lower 30-day readmission rates, most current strategies are not associated with lower readmission rates.Background—Reducing 30-day heart failure readmission rates is a national priority. Yet, little is known about how hospitals address the problem and whether hospital-based processes of care are associated with reductions in readmission rates. Methods and Results—We surveyed 100 randomly selected hospitals participating in the Get With the Guidelines-Heart Failure quality improvement program regarding common processes of care aimed at reducing readmissions. We grouped processes into 3 domains (ie, inpatient care, discharge and transitional care, and general quality improvement) and scored hospitals on the basis of survey responses using processes selected a priori. We used linear regression to examine associations between these domain scores and 30-day risk-standardized readmission rates. Of the 100 participating sites, 28% were academic centers and 64% were community hospitals. The median readmission rate among participating sites (24.0%; 95% CI, 22.6%–25.7%) was comparable with the national average (24.6%; 23.5–25.9). Sites varied substantially in care processes used for inpatient care, education, discharge process, care transitions, and quality improvement. Overall, neither inpatient care nor general quality improvement domains were associated with 30-day readmission rates. Hospitals in the lowest readmission rate quartile had modestly higher discharge and transitional care domain scores (P=0.03). Conclusions—A variety of strategies are used by hospitals in an attempt to improve 30-day readmission rates for patients hospitalized with heart failure. Although more complete discharge and transitional care processes may be modestly associated with lower 30-day readmission rates, most current strategies are not associated with lower readmission rates.

Development of the NIH PROMIS ® Sexual Function and Satisfaction measures in patients with cancer.

INTRODUCTION We describe the development and validation of the Patient-Reported Outcomes Measurement Information System(®) Sexual Function and Satisfaction (PROMIS(®) SexFS; National Institutes of Health) measures, version 1.0, for cancer populations. AIM To develop a customizable self-report measure of sexual function and satisfaction as part of the U.S. National Institutes of Health PROMIS Network. METHODS Our multidisciplinary working group followed a comprehensive protocol for developing psychometrically robust patient-reported outcome measures including qualitative (scale development) and quantitative (psychometric evaluation) development. We performed an extensive literature review, conducted 16 focus groups with cancer patients and multiple discussions with clinicians, and evaluated candidate items in cognitive testing with patients. We administered items to 819 cancer patients. Items were calibrated using item-response theory and evaluated for reliability and validity. MAIN OUTCOME MEASURES The PROMIS SexFS measures, version 1.0, include 81 items in 11 domains: Interest in Sexual Activity, Lubrication, Vaginal Discomfort, Erectile Function, Global Satisfaction with Sex Life, Orgasm, Anal Discomfort, Therapeutic Aids, Sexual Activities, Interfering Factors, and Screener Questions. RESULTS In addition to content validity (patients indicate that items cover important aspects of their experiences) and face validity (patients indicate that items measure sexual function and satisfaction), the measure shows evidence for discriminant validity (domains discriminate between groups expected to be different) and convergent validity (strong correlations between scores on PROMIS and scores on conceptually similar older measures of sexual function), as well as favorable test-retest reliability among people not expected to change (interclass correlations from two administrations of the instrument, 1 month apart). CONCLUSIONS The PROMIS SexFS offers researchers a reliable and valid set of tools to measure self-reported sexual function and satisfaction among diverse men and women. The measures are customizable; researchers can select the relevant domains and items comprising those domains for their study.

Initial report of the cancer patient-reported outcomes measurement information system (PROMIS) sexual function committee: Review of sexual function measures and domains used in oncology

For this report, the authors described the initial activities of the Cancer Patient‐Reported Outcomes Measurement Information System (PROMIS)‐Sexual Function domain group, which is part of the National Institutes of Health Roadmap Initiative to develop brief questionnaires or individually tailored assessments of quality‐of‐life domains. Presented are a literature review of sexual function measures used in cancer populations and descriptions of the domains found in those measures. By using a consensus‐driven approach, an electronic bibliographic search was conducted for articles that were published from 1991 to 2007, and 486 articles were identified for in‐depth review. In total, 257 articles reported the administration of a psychometrically evaluated sexual function measure to individuals who were diagnosed with cancer. Apart from the University of California‐Los Angeles Prostate Cancer Index, the International Index of Erectile Function, and the Female Sexual Function Index, the 31 identified measures have not been tested widely in cancer populations. Most measures were multidimensional and included domains related to the sexual response cycle and to general sexual satisfaction. The current review supports the need for a flexible, psychometrically robust measure of sexual function for use in oncology settings and strongly justifies the development of the PROMIS‐Sexual Function instrument. When the PROMIS‐Sexual Function instrument is available publicly, cancer clinicians and researchers will have another measure with which to assess patient‐reported sexual function outcomes in addition to the few legacy measures that were identified through this review. Cancer 2009.

Outcomes, health policy, and managed care: relationships between patient-reported outcome measures and clinical measures in outpatients with heart failure.

BACKGROUND Patient-reported outcomes are increasingly used to assess the efficacy of new treatments. Understanding relationships between these and clinical measures can facilitate their interpretation. We examined associations between patient-reported measures of health-related quality of life and clinical indicators of disease severity in a large, heterogeneous sample of patients with heart failure. METHODS Patient-reported measures, including the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the EuroQol Visual Analog Scale (VAS), and clinical measures, including peak VO(2), 6-minute walk distance, and New York Heart Association (NYHA) class, were assessed at baseline in 2331 patients with heart failure. We used general linear models to regress patient-reported measures on each clinical measure. Final models included for significant sociodemographic variables and 2-way interactions. RESULTS The KCCQ was correlated with peak VO(2) (r = .21) and 6-minute walk distance (r = .27). The VAS was correlated with peak VO(2) (r = .09) and 6-minute walk distance (r = .11). Using the KCCQ as the response variable, a 1-SD difference in peak Vo(2) (4.7 mL/kg/min) was associated with a 2.86-point difference in the VAS (95% CI, 1.98-3.74) and a 4.75-point difference in the KCCQ (95% CI, 3.78-5.72). A 1-SD difference in 6-minute walk distance (105 m) was associated with a 2.78-point difference in the VAS (95% CI, 1.92-3.64) and a 5.92-point difference in the KCCQ (95% CI, 4.98-6.87); NYHA class III was associated with an 8.26-point lower VAS (95% CI, 6.59-9.93) and a 12.73-point lower KCCQ (95% CI, 10.92-14.53) than NYHA class II. CONCLUSIONS These data may inform deliberations about how to best measure benefits of heart failure interventions, and they generally support the practice of considering a 5-point difference on the KCCQ and a 3-point difference on the VAS to be clinically meaningful.

Using cognitive interviews to evaluate items for measuring sexual functioning across cancer populations: improvements and remaining challenges

PurposeOne goal of the Patient-Reported Outcomes Measurement Information System™ (PROMIS™) is to develop a measure of sexual functioning that broadens the definition of sexual activity and incorporates items that reflect constructs identified as important by patients with cancer. We describe how cognitive interviews improved the quality of the items and discuss remaining challenges to assessing sexual functioning in research with cancer populations.MethodsWe conducted 39 cognitive interviews of patients with cancer and survivors on the topic of sexual experience. Each of the 83 candidate items was seen by 5–24 participants. Participants included both men and women and varied by cancer type, treatment trajectory, race, and literacy level. Significantly revised items were retested in subsequent interviews.ResultsCognitive interviews provided useful feedback about the relevance, sensitivity, appropriateness, and clarity of the items. Participants identified broad terms (e.g., “sex life”) to assess sexual experience and exposed the challenges of measuring sexual functioning consistently, considering both adjusted and unadjusted sexual experiences.ConclusionsCognitive interviews were critical for item refinement in the development of the PROMIS measure of sexual function. Efforts are underway to validate the measure in larger cancer populations.

Development and Initial Validation of the PROMIS® Sexual Function and Satisfaction Measures Version 2.0

INTRODUCTION The Patient-Reported Outcomes Measurement Information System (PROMIS)(®) Sexual Function and Satisfaction measure (SexFS) version 1.0 was developed with cancer populations. There is a need to expand the SexFS and provide evidence of its validity in diverse populations. AIM The aim of this study was to describe the development of the SexFS v2.0 and present preliminary evidence for its validity. METHODS Development built on version 1.0, plus additional review of extant items, discussions with 15 clinical experts, 11 patient focus groups (including individuals with diabetes, heart disease, anxiety, depression, and/or are lesbian, gay, bisexual, or aged 65 or older), 48 cognitive interviews, and psychometric evaluation in a random sample of U.S. adults plus an oversample for specific sexual problems (2281 men, 1686 women). We examined differential item functioning (DIF) by gender and sexual activity. We examined convergent and known-groups validity. RESULTS The final set of domains includes 11 scored scales (interest in sexual activity, lubrication, vaginal discomfort, clitoral discomfort, labial discomfort, erectile function, orgasm ability, orgasm pleasure, oral dryness, oral discomfort, satisfaction), and six nonscored item pools (screeners, sexual activities, anal discomfort, therapeutic aids, factors interfering with sexual satisfaction, bother). Domains from version 1.0 were reevaluated and improved. Domains considered applicable across gender and sexual activity status, namely interest, orgasm, and satisfaction, were found to have significant DIF. We identified subsets of items in each domain that provided consistent measurement across these important respondent groups. Convergent and known-groups validity was supported. CONCLUSIONS The SexFS version 2.0 has several improvements and enhancements over version 1.0 and other extant measures, including expanded evidence for validity, scores centered around norms for sexually active U.S. adults, new domains, and a final set of items applicable for both men and women and those sexually active with a partner and without. The SexFS is customizable, allowing users to select relevant domains and items for their study.