Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Flynn KE

PROVIDER: S-EPMC2805910 | biostudies-literature | 2009 Oct

REPOSITORIES: biostudies-literature

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Publications

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

Flynn Kathryn E KE Lin Li L Ellis Stephen J SJ Russell Stuart D SD Spertus John A JA Whellan David J DJ Piña Ileana L IL Fine Lawrence J LJ Schulman Kevin A KA Weinfurt Kevin P KP

American heart journal 20091001 4 Suppl

<h4>Background</h4>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.<h4>Methods</h4>Patient-reported measures, including the Kansas City Cardiomyopathy Quest ...[more]

PMID: 19782791

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Project description:Patient-reported outcome measures (PROMs) are increasingly used to quantify patients' perceptions of functional ability. The American Medical Association and NIH suggest patient materials be written at or below 6th to 8th grade reading levels, respectively, yet one recent study asserts that few PROMs comply with these recommendations, and suggests that the majority of PROMs are written at too high of a reading level for self-administered patient use. Notably, this study was limited in its use of only one readability algorithm, although there is no commonly accepted, standard readability algorithm for healthcare-related materials. Our study, using multiple readability equations and heeding equal weight to each, hopes to yield a broader, all-encompassing estimate of readability, thereby offering a more accurate assessment of the readability of orthopaedic PROMS.(1) What proportion of orthopaedic-related PROMs and orthopaedic-related portions of the NIH Patient Reported Outcomes Measurement Information System (PROMIS®) are written at or below the 6th and 8th grade levels? (2) Is there a correlation between the number of questions in the PROM and reading level? (3) Using systematic edits based on guidelines from the Centers for Medicare and Medicaid Services, what proportion of PROMs achieved American Medical Association and NIH-recommended reading levels?Eighty-six (86) independent, orthopaedic and general wellness PROMs, drawn from commonly referenced orthopaedic websites and prior studies, were chosen for analysis. Additionally, owing to their increasing use in orthopaedics, four relevant short forms, and 11 adult, physical health question banks from the PROMIS®, were included for analysis. All documents were analyzed for reading grade levels using 19 unique readability algorithms. Descriptive statistics were performed using SPSS Version 22.0.The majority of the independent PROMs (64 of 86; 74%) were written at or below the 6th grade level, with 81 of 86 (94%) written at or below the 8th grade level. All item banks (11 of 11) and short forms (four of four) of the PROMIS® were written below the 6th grade reading level. The median reading grade level of the 86 independent PROMs was 5.0 (interquartile range [IQR], 4.6-6.1). The PROMIS® question banks had a median reading grade level of 4.1 (IQR, 3.5-4.8); the Adult Short Forms had a median reading grade level of 4.2 (IQR, 4.2-4.3) There was no correlation appreciated between the median reading grade level and the number of questions contained in a PROM (r = -0.081; p = 0.460). For PROMs above NIH-recommended levels, following edits, all (five of five) achieved NIH reading level goals and three (three of five) achieved American Medical Association goals. Editing of these PROMs improved readability by 4.3 median grade level (before, 8.9 [IQR, 8.4-9.1], after 4.6 [IQR, 4.6-6.4], difference of medians, 4.3; p = 0.008).Patient literacy has great influence on healthcare outcomes, and readability is an important consideration in all patient-directed written materials. Our study found that more than 70% of PROMs commonly used in orthopaedics, and all orthopaedic-related portions of the PROMIS® are written at or below the most stringent recommendations (? 6th grade reading level), and more than 90% of independent PROMs and all PROMIS® materials are written at or below an 8th grade level. Additionally, the use of the Centers for Medicare and Medicaid Services guidelines for editing high reading level PROMs yields satisfactory results.Fears of widely incomprehensible PROMs may be unfounded. Future research to identify the most appropriate readability algorithm for use in the healthcare sector, and revalidation of PROMs after readability-improving edits is warranted.

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Dataset Information

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

Background

Methods

Results

Conclusions

Publications

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

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