Single-item electronic administration of the SF-36v2 Health Survey.

PURPOSE: To evaluate the psychometric properties and factor structure of a computerized electronic version of the SF-36v2 Health Survey (SF-36v2) with items administered one-per-page versus the traditional grid format used in the paper-and-pencil version in a sample of physician-diagnosed headache patients. METHODS: Patients (N = 180) completed the SF-36v2 administered as part of a broader study of health outcomes. Scaling assumptions, reliability, factor structure, and the tool's ability to discriminate between headache pain severity groups were examined. RESULTS: Frequency distributions showed notable ceiling effects for the role emotional, social functioning, physical functioning, and role physical scales, but negligible (<1.2%) floor effects for any of the scales. Internal consistency reliability coefficients ranged from 0.81 to 0.95 for the eight health domains. Items passed tests of internal consistency and discriminant validity. Principal components' analyses confirmed the 2-factor structure; the pattern of correlations across scales was consistent with expectations for the physical and mental health components. As expected, patients with severe headache pain had lower mean SF-36v2 scores than those with mild or moderate pain. No significant score differences were observed between mild and moderate pain severity groups. CONCLUSIONS: Single-item electronic administration of the SF-36v2 is reliable and valid for use with headache patients.

Cognitive testing and readability of an item bank for measuring the impact of headache on health-related quality of life.

BACKGROUND: Patient-reported outcomes (PRO) measures should be valid and accessible to a wide audience. OBJECTIVE: Cognitive item testing and readability studies were conducted to evaluate how adult headache sufferers (N = 9) understood and responded to the Headache Impact Test (HIT™) item bank, a PRO measure for headache that serves as the source of item content for the HIT-6™ (a widely used six-item short-form measure of headache impact with more than 30 language translations), and the Dynamic Health Assessment Headache Impact Test (DYNHA® HIT™) [a computerized adaptive test (CAT) of headache impact]. METHODS: During cognitive interviews, participants were asked to 'think aloud' as they read survey instructions, completed items, and formulated responses. Data analyses evaluated item comprehension, memory recall of relevant information, and decision and response processes; compared various item attributes; and tested shortened item versions. RESULTS: Survey readability was at the seventh-grade level. Respondents understood most revised items as intended, and found shorter items comparable to longer items with some exceptions. When recall period was included in instructions but not within the items themselves, respondents often expanded the recall period to answer the item. Some response scales (e.g. "Never" to "Always") were more readily understood than others (e.g. "Definitely true" to "Definitely false"). CONCLUSION: Qualitative research can improve the validity and accessibility of PRO measures that are used to monitor health conditions and aid patient-provider communication.

A computerized adaptive version of the SF-36 is feasible for clinic and Internet administration in adults with HIV.

DYNHA SF-36 is a computerized adaptive test version of the SF-36 Health Survey. The feasibility of administering a modified DYNHA SF-36 to adults with HIV was evaluated with Johns Hopkins University Moore (HIV) Clinic patients (N=100) and Internet consumer health panel members (N=101). Participants completed the DYNHA SF-36, modified to capture seven health domains [(physical function (PF), role function (RF, without physical or emotional attribution), bodily pain (BP), general health, vitality (VT), social function (SF), mental health (MH)], and scored to produce two summary components [Physical Component Summary (PCS), Mental Component Summary (MCS)]. Item-response theory-based response consistency, precision, mean scores, and discriminant validity were examined. A higher percentage of Internet participants responded consistently to the DYNHA SF-36. For each domain, three standard deviations were covered with five items (90% reliability); however, RF and SF scores were less precise at the upper end of measurement (better functioning). Mean scores were slightly higher for the Internet sample, with the exception of VT and MCS. Clinic and Internet participants reporting an AIDS diagnosis had significantly lower mean PCS and PF scores than those without a diagnosis. Additionally, significantly lower RF and BP scores were found for Internet participants reporting an AIDS diagnosis. The measure was well accepted by the majority of participants, although Internet respondents provided lower ratings for the tool's usefulness. The DYNHA SF-36 has promise for measuring the impact of HIV and its treatment in both the clinic setting and through telemonitoring.

Development of a computerized adaptive test to assess health-related quality of life in adults with asthma.

OBJECTIVE: The purpose of this research was to calibrate an item bank for a computerized adaptive test (CAT) of asthma impact on health-related quality of life (HRQOL), test CAT versions of varying lengths, conduct preliminary validity testing, and evaluate item bank readability. METHODS: Asthma Impact Survey (AIS) bank items that passed focus group, cognitive testing, and clinical and psychometric reviews were administered to adults with varied levels of asthma control. Adults self-reporting asthma (N = 1106) completed an Internet survey including 88 AIS items, the Asthma Control Test, and other HRQOL outcome measures. Data were analyzed using classical and modern psychometric methods, real-data CAT simulations, and known groups validity testing. RESULTS: A bi-factor model with a general factor (asthma impact) and several group factors (cognitive function, fatigue, mental health, physical function, role function, sexual function, self-consciousness/stigma, sleep, and social function) was tested. Loadings on the general factor were above 0.5 and were substantially larger than group factor loadings, and fit statistics were acceptable. Item functioning for most items and fit to the model was acceptable. CAT simulations demonstrated several options for administration and stopping rules. AIS distinguished between respondents with differing levels of asthma control. CONCLUSIONS: The new 50-item AIS item bank demonstrated favorable psychometric characteristics, preliminary evidence of validity, and accessibility at moderate reading levels. Developing item banks for CAT can improve the precise, efficient, and comprehensive monitoring of asthma outcomes and may facilitate patient-centered care.

Heuristic evaluation and usability testing of a computerized patient-reported outcomes survey for headache sufferers.

OBJECTIVE: The aim of this study was to evaluate usability of a prototype tablet PC-administered computerized adaptive test (CAT) of headache impact and patient feedback report, referred to as HEADACHE-CAT. MATERIALS AND METHODS: Heuristic evaluation specialists (n = 2) formed a consensus opinion on the application's strengths and areas for improvement based on general usability principles and human factors research. Usability testing involved structured interviews with headache sufferers (n = 9) to assess how they interacted with and navigated through the application, and to gather input on the survey and report interface, content, visual design, navigation, instructions, and user preferences. RESULTS: Specialists identified the need for improved instructions and text formatting, increased font size, page setup that avoids scrolling, and simplified presentation of feedback reports. Participants found the tool useful, and indicated a willingness to complete it again and recommend it to their healthcare provider. However, some had difficulty using the onscreen keyboard and autoadvance option; understanding the difference between generic and headache-specific questions; and interpreting score reports. CONCLUSIONS: Heuristic evaluation and user testing can help identify usability problems in the early stages of application development, and improve the construct validity of electronic assessments such as the HEADACHE-CAT. An improved computerized HEADACHE-CAT measure can offer headache sufferers an efficient tool to increase patient self-awareness, monitor headaches over time, aid patient-provider communications, and improve quality of life.

Using qualitative research to inform the development of a comprehensive outcomes assessment for asthma.

BACKGROUND: : Qualitative research can inform the development of asthma patient-reported outcome (PRO) measures and user-friendly technologies through defining measurement constructs, identifying potential limitations in measurement and sources of response error, and evaluating usability. OBJECTIVE: : To inform the development of a comprehensive asthma PRO assessment with input from patients and clinical experts. METHODS: : Self-reported adult asthma patients recruited from a 3000-member New England area research panel participated in either one of three focus groups (n = 21) or individual cognitive item debriefing interviews (n = 20) to discuss how asthma impacts their health-related quality of life (HR-QOL), and provide feedback on a preliminary set of asthma impact survey items and prototype patient reports. Focus groups and cognitive interviews were conducted using traditional research principles (e.g. semi-structured interview guide, probing, and think aloud techniques). An expert advisory panel (n = 12) including asthma clinical specialists and measurement professionals was convened to review results from the focus group and cognitive interview studies, and make recommendations for final survey and report development. RESULTS: : Domains of health impacted by asthma included physical (recreation, play, competitive sports, and exercise), social (activities, family relationships), emotional (anger, upset, frustration, anxiety, worry), sleep, role (recreational/leisure activities, work), and sexual functioning. Most items in the impact survey were easily understood, covered important content, and included relevant response options. Items with contradictory examples and multiple concepts were difficult to comprehend. Suggestions were made to expand survey content by including additional items on physical and sexual functioning, sleep, self-consciousness, stigma, and finances. Reports were considered useful and participants saw value in sharing the results with their doctors. Graphic presentation of scores was not always understood; participants preferred tabular presentation of score levels with associated interpretative text. Display of inverse scores for different measures (higher scores equaling better health on one scale and worse health on another) shown on a single page was confusing. The score history section of the report was seen as helpful for monitoring progress over time, particularly for those recently diagnosed with asthma.Expert panelists agreed that displaying inverse scores in a single summary report could be confusing to patients and providers. They also stressed the importance of comprehensive interpretation guidelines for patients, with an emphasis on what they should do next based on scores. Panelists made recommendations for provider and aggregate-level reports (e.g. 'red flags' to indicate significant score changes or cut points of significance; identification of subgroups that have scored poorly or recently got worse). CONCLUSION: : Incorporating input from patients, clinicians, and measurement experts in the early stages of product development should improve the construct validity of this PRO measure and enhance its practical application in healthcare.

Using Qualitative Research to Inform the Development of a Comprehensive Outcomes Assessment for Asthma.

BACKGROUND: Qualitative research can inform the development of asthma patient-reported outcome (PRO) measures and user-friendly technologies through defining measurement constructs, identifying potential limitations in measurement and sources of response error, and evaluating usability. OBJECTIVE: The goal of the current study was to inform the development of a comprehensive asthma PRO assessment with input from patients and clinical experts. METHOD: Self-reported adult asthma sufferers recruited from a 3,000 member New England-area research panel participated in either one of three focus groups (N=21) or individual cognitive item debriefing interviews (N=20) to discuss how asthma impacts their health-related quality of life (HRQOL), and provide feedback on a preliminary set of asthma impact survey items and prototype patient report. Focus groups and cognitive interviews were conducted using traditional research principles (e.g., semi-structured interview guide, probing, and think aloud techniques). An Expert Advisory Panel (N=12) including asthma clinical specialists and measurement professionals was convened to review results from the focus group and cognitive interview studies and make recommendations for final survey and report development. RESULTS: Domains of health impacted by asthma included physical (recreation, play, competitive sports, and exercise), social (activities, family relationships), emotional (anger, upset, frustration, anxiety, worry), sleep, role (recreational/leisure activities; work), and sexual functioning. Most items in the impact survey were easily understood, covered important content, and included relevant response options. Items with contradictory examples and multiple concepts were difficult to comprehend. Suggestions were made to expand survey content by including additional items on physical and sexual functioning, sleep, self-consciousness, stigma, and finances. Reports were considered useful and participants saw value in sharing the results with their doctor. Graphic presentation of scores was not always understood; participants preferred tabular presentation of score levels with associated interpretative text. Display of inverse scores for different measures (higher scores equaling better health on one scale and worse health on another) shown on a single page was confusing. The score history section of the report was seen as helpful for monitoring progress over time, particularly for those recently diagnosed with asthma. Expert panelists agreed that displaying inverse scores in a single summary report may be confusing to patients and providers. They also stressed the importance of comprehensive interpretation guidelines for patients, with an emphasis on what they should do next based on scores. Panelists made recommendations for provider and aggregate-level reports (e.g., "red flags" to indicate significant score changes or cut-points of significance; identification of subgroups that have scored poorly or recently gotten worse). CONCLUSION: Incorporating input from patients, clinicians, and measurement experts in the early stages of product development should improve the construct validity of this PRO measure and enhance its practical application in healthcare.

PPARalpha activation elevates blood pressure and does not correct glucocorticoid-induced insulin resistance in humans.

Fibrates, activators of the nuclear receptor PPARalpha, improve dyslipidemia, but their effects on insulin resistance and vascular disease are unresolved. To test the hypothesis that PPARalpha activation improves insulin resistance and vascular function, we determined the effects of fenofibrate in healthy adults with insulin resistance induced by short-term glucocorticoid administration. Eighteen normal-weight subjects were studied in four stages: at baseline, after 21 days of fenofibrate (160 mg/day) alone, after 3 days of dexamethasone (8 mg/day) added to fenofibrate, and after 3 days of dexamethasone added to placebo (dexamethasone alone). Dexamethasone alone caused hyperinsulinemia, increased glucose, decreased glucose disposal, and reduced insulin-induced suppression of hepatic glucose production as determined by hyperinsulinemic euglycemic clamp and increased systolic blood pressure as determined by ambulatory monitoring, features associated with an insulin-resistant state. Fenofibrate improved fasting LDL and total cholesterol in the setting of dexamethasone treatment but had no significant effect on levels of insulin or glucose, insulin-stimulated glucose disposal, or insulin suppression of glucose production during clamps, or ambulatory monitored blood pressure. In the absence of dexamethasone, fenofibrate lowered fasting triglycerides and cholesterol but unexpectedly increased systolic blood pressure by ambulatory monitoring. These data suggest that PPARalpha activation in humans does not correct insulin resistance induced by glucocorticoids and may adversely affect blood pressure.

Hypoglycemia and the sympathoadrenal system: neurogenic symptoms are largely the result of sympathetic neural, rather than adrenomedullary, activation.

The relative contributions of the sympathetic nervous system and the adrenal medullae, the two components of the sympathoadrenal system, to the manifestations of hypoglycemia are largely unknown. We tested the hypothesis that the neurogenic symptoms of hypoglycemia are largely the result of sympathetic neural activation. To do so, we quantitated neurogenic symptoms, as well as norepinephrine (NE) kinetics and selected hemodynamic changes, during hyperinsulinemic euglycemic and stepped hypoglycemic clamps in 15 healthy control subjects (Controls) and four bilaterally adrenalectomized patients (ADX). Plasma epinephrine responses to hypoglycemia were virtually absent in ADX, as expected. Neurogenic symptom scores increased to higher values during the hypoglycemic compared with the euglycemic clamps in both Controls (P < 0.0001) (e.g., final scores of 7.8 +/- 1.2 vs. 3.0 +/- 0.7) and ADX (P < 0.0001) (e.g., final scores of 10.8 +/- 4.1 vs. 2.5 +/- 1.0). Plasma NE concentrations (P < 0.0001) and systemic NE spillover (P = 0.0007) increased during the hypoglycemic compared with the euglycemic clamps in Controls but not in ADX. Similarly, heart rate increased (P = 0.0104), diastolic blood pressure decreased (P = 0.0003), and forearm blood flow increased (P < 0.0001) during the hypoglycemic compared with the euglycemic clamps in Controls but not in ADX. These data indicate that the neurogenic symptoms of hypoglycemia are largely the result of sympathetic neural, rather than adrenomedullary, activation. They also suggest that the plasma NE and hemodynamic responses to hypoglycemia are largely the result of adrenomedullary, rather that sympathetic neural, activation.