A study of the feasibility of Internet administration of a computerized health survey: the headache impact test (HIT).

BACKGROUND: Headache impact test (HIT) is a precise, practical tool that quantifies the impact of headache on respondents' lives. It is the first widely-available dynamic health assessment (DynHA). Applications of this brief, precise survey include population based screening for disabling headaches, tracking of individual patient scores over time, disease management programs and others. We use data from Internet HIT assessments during the fall of 2000 to (1) evaluate characteristics of respondents and assessments, (2) assess the utility of joint administration of HIT and the SF-8 Health Survey (SF-8) to screen for migraine and depression, and (3) explore associations between HIT scores and subsequent healthcare-related attitudes and behaviors. METHODS: We analyzed Internet HIT surveys completed between 9/1 and 11/30/2000 (n = 19,195). Subsamples include respondents who also completed (1) a 12-item Internet survey assessing severity, frequency, cause and management of headaches; (2) an e-mail survey measuring healthcare-related behaviors; (3) the SF-8; or (4) the website registration process, providing age and gender data. We used analysis of variance (ANOVA) to evaluate HIT score differences associated with age, gender, headache severity or frequency, and healthcare-related behaviors and attitudes and chi2 tests to assess the prevalence and comorbidity of migraine and depression. RESULTS: Three-quarters of respondents achieved a precise HIT score in < or = 5 items. Most had moderate/severe headaches; 65% had headaches at least monthly. HIT scores were directly related to headache severity and frequency. Most respondents were females, with significantly higher HIT scores than males. Most HIT respondents were between ages 25 and 54 (HIT scores were higher for younger respondents). Sixty four percent screened positive for migraine; 20% for depression. Both conditions were more prevalent among females than males. Comorbid migraine and depression was 50% more prevalent among females and increased with age until age 50. Patients with worse headache impact were more likely to seek care, discuss headaches with their providers and find HIT useful. CONCLUSIONS: It is feasible to use Internet-based dynamic assessments to measure health status. These data complement previous results showing that HIT differentiates respondents according to headache characteristics (severity and frequency). HIT plus SF-8 yields a practical screen for migraine and depression in headache patients and may lead to more effective treatment for patients with these conditions. Preliminary findings suggest that the experience of taking HIT on the Internet may motivate headache patients to seek care and discuss headaches with their providers.

A six-item short-form survey for measuring headache impact: the HIT-6.

BACKGROUND: Migraine and other severe headaches can cause suffering and reduce functioning and productivity. Patients are the best source of information about such impact. OBJECTIVE: To develop a new short form (HIT-6) for assessing the impact of headaches that has broad content coverage but is brief as well as reliable and valid enough to use in screening and monitoring patients in clinical research and practice. METHODS: HIT-6 items were selected from an existing item pool of 54 items and from 35 items suggested by clinicians. Items were selected and modified based on content validity, item response theory (IRT) information functions, item internal consistency, distributions of scores, clinical validity, and linguistic analyses. The HIT-6 was evaluated in an Internet-based survey of headache sufferers (n = 1103) who were members of America Online (AOL). After 14 days, 540 participated in a follow-up survey. RESULTS: HIT-6 covers six content categories represented in widely used surveys of headache impact. Internal consistency, alternate forms, and test-retest reliability estimates of HIT-6 were 0.89, 0.90, and 0.80, respectively. Individual patient score confidence intervals (95%) of app. +/-5 were observed for 88% of all respondents. In tests of validity in discriminating across diagnostic and headache severity groups, relative validity (RV) coefficients of 0.82 and 1.00 were observed for HIT-6, in comparison with the Total Score. Patient-level classifications based in HIT-6 were accurate 88.7% of the time at the recommended cut-off score for a probability of migraine diagnosis. HIT-6 was responsive to self-reported changes in headache impact. CONCLUSIONS: The IRT model estimated for a 'pool' of items from widely used measures of headache impact was useful in constructing an efficient, reliable, and valid 'static' short form (HIT-6) for use in screening and monitoring patient outcomes.

The effects of interferon alpha-2b in combination with ribavirin on health related quality of life and work productivity.

BACKGROUND/AIMS: Interferon plus ribavirin is the most effective therapy for chronic hepatitis C. The aim of this study was to evaluate the effect of chronic hepatitis C and therapy on health-related quality of life and work functioning. METHODS: Nine hundred and twelve patients with hepatitis C infection were randomized in a controlled trial of Interferon alpha 2b 3 MU tiw for 24 or 48 weeks plus ribavirin 1000-1200 mg or placebo. Questionnaire-based assessments of health-related quality of life and work functioning were performed before, during, and after treatment. Outcome measures included the SF-36 Health Survey and additional generic and specific scales. Work functioning was assessed as missed days, shorter hours or less productivity at work. RESULTS: Pre-treatment, patients had significant impairment in five of eight SF-36 concepts compared to matched population norms. Sustained responders had a return to normal for four of these five concepts. Quality of life did not improve in non-responders. Improvements in histology, viral load or ALT values predicted improvements in quality of life. Sustained responders also had improvements in work functioning and productivity. CONCLUSIONS: Hepatitis C patients had impaired quality of life. After combination therapy, sustained virologic responders achieved benefits in their quality of life and work functioning.

A new tool for monitoring asthma outcomes: the ITG Asthma Short Form.

BACKGROUND: Asthma treatment has broadened from managing clinical markers to incorporate factors that are most meaningful to patients, collectively called health-related quality of life (HQL). OBJECTIVE: To develop an asthma-specific HQL tool, meeting demands for brevity, usefulness and measurement precision. METHODS: The 20-item Sydney Asthma Quality of Life Questionnaire (AQLQ) and six additional items were studied using factor analysis, reliability and validity tests among asthma patients 14 and older. RESULTS: The 15-item Integrated Therapeutics Group Asthma Short Form (ITG-ASF) retains the validity of the AQLQ with improved scaling properties and interpretability. The ITG-ASF yields 6 scores: Symptom-Free Index, Functioning with Asthma, Psychosocial Impact of Asthma, Asthma Energy and Asthma-Confidence in Health and a Total. All items correlated 0.40 or higher with their hypothesized scales and passed discriminant validity tests, with scaling success rates from 75 to 100%. Reliability exceeded the minimum of 0.70 for group comparisons. Ceiling and floor effects were acceptable. Scales were valid in relation to changes in asthma severity and lung function. The best predictor of asthma severity (National Asthma Education and Prevention Program (NAEPP) staging) was the Symptom-Free Index. A Spanish translation is available, Chinese-American is forthcoming. The reading grade level is 4.8. CONCLUSIONS: Development of the ITG-ASF was a data-driven process maximizing measurement precision and breadth while minimizing burden. The ITG-ASF is a brief, comprehensive and empirically valid tool that complements traditional markers of the outcomes of asthma care.

Impact of changes in asthma severity on health-related quality of life in pediatric and adult asthma patients: results from the asthma outcomes monitoring system.

The goals of asthma treatment have broadened beyond managing traditional clinical markers of disease severity, and now include a focus on benefits of treatment in terms that are most meaningful to patients. Measurement of both generic and disease-specific health-related quality of life (HQL) is advocated because each provides complementary information about how the condition affects everyday functioning and well-being and whether treatments have their intended effects. The purpose of this study was to determine the impact of changes in asthma severity (defined using NHLBI/NAEPP severity staging) on patient-assessed HQL. Two hundred and thirty-three pediatric asthma patients and 269 adult asthma patients were evaluated in a one-year observational study. Analyses were performed to compare the generic and asthma-specific scores for patients whose asthma severity improved, stayed the same, or worsened over one year. The asthma-specific scales are sensitive to changes in disease severity. Of the generic scales, those tapping areas of physical health are more affected than the mental/emotional scales. This confirms that HQL measures are responsive to changes in asthma severity. They complement traditional clinical markers used to evaluate changes in a patient's disease state and thus give the physician another useful tool in following the clinical progress of the child with asthma.

Methods in outcomes research in hepatology: definitions and domains of quality of life.

The health care system in the United States is at a turning point. We are experiencing a shift in focus from structure and process to outcomes, and from specific clinical outcomes to generic outcomes. It is no longer sufficient to document where and how care is delivered and what clinical indicators were changed through various interventions. Rather, payers, employers, and patients themselves demand evidence that the health care system produces patients who feel better, can do more, and are confident about their health. These concepts, collectively referred to as Health-Related Quality of Life (HQL), are an important aspect of the natural history of liver diseases and an important means of assessing the results of therapeutic interventions.

Health-related quality of life in chronic hepatitis C: impact of disease and treatment response. The Interventional Therapy Group.

Hepatitis C infects nearly 4 million Americans. Most have chronic hepatitis C (CHC), which progresses to cirrhosis in about 20% of patients. Interferon treatment leads to transient responses in about 40% of patients and apparent eradication of infection in 7% to 40% of patients. In this report, we document the impact of CHC on health-related quality of life (HQL), and changes in HQL among treatment responders. Three hundred twenty-four CHC patients from 10 countries who had relapsed after responding to interferon-alfa therapy were randomized to monotherapy (IFN alfa-2b + placebo) or combination therapy (IFN alfa-2b + ribavirin), treated for 24 weeks, and followed up for 24 weeks. HQL was assessed using the Hepatitis Quality of Life Questionnaire (HQLQ), containing the generic SF-36 Health Survey, three additional generic scales, and two hepatitis-specific scales. Before treatment, CHC patients were impaired in 5 of 8 SF-36 concepts (physical functioning, role-physical, general health, vitality, and social functioning) in comparison with matched population norms. Sustained virological response (SVR) to treatment yielded improvements on three generic scales (vitality, social functioning, and health distress) and the CHC-specific health distress scale. Overall response to treatment (SVR plus histological improvement) yielded the same pattern of improvements with additional gains in generic general health and CHC-specific limitations. Successful treatment of CHC improved HQL as measured by both CHC-specific and generic measures of functional health and well being.

Sustained virologic response is associated with improved health-related quality of life in relapsed chronic hepatitis C patients.

Although evidence of virologic elimination, normalization of serum alanine aminotransferase levels, and reduction in liver inflammation are the principal therapeutic outcome goals in chronic hepatitis C patients, improvement in health-related quality of life (HQL) is also an important aspect of therapeutic outcome. In a recent report of chronic hepatitis C patients treated for 24 weeks with interferon, sustained virologic response (24 weeks post-treatment) was associated with improvement in HQL compared with nonresponse. We report on the relationship between sustained virologic response and Hepatitis Quality-of-Life Questionnaire (HQLQ) survey results of patients who relapsed after a previous course of interferon alfa who were subsequently treated with recombinant interferon alfa-2b (rIFN-alpha 2b) either alone or in combination with ribavirin. The HQLQ was administered at baseline, at treatment Weeks 12 and 24, and at follow-up Weeks 12 and 24. All patients received rIFN-alpha 2b 3 million International Units by subcutaneous injection three times weekly plus either oral ribavirin (1,000 or 1,200 mg) or placebo daily for 24 weeks. At baseline, patients scored lower than adjusted population norms in HQL. Relative to patients treated with rIFN-alpha 2b monotherapy, patients receiving combination therapy showed better HQL in 6 of 13 domains. Furthermore, sustained virologic response in either treatment group was associated with improvement in the scores of both generic and hepatitis-specific HQL survey domains. These results indicate that successful therapeutic resolution of hepatitis C infection improves HQL as assessed by generic and hepatitis C-specific measures of functional health and well-being. Furthermore, improvements in HQL outcome measures may predict reduced demand for health care resources and greater productivity in the workplace.

A questionnaire to assess the generic and disease-specific health outcomes of patients with chronic hepatitis C.

A 69-item questionnaire measuring generic functioning and well-being and disease-specific health outcomes was developed and tested using the pre-treatment data from patients with chronic hepatitis C (CHC) participating in two randomized trials of interferon alpha-2b (n = 157). The questionnaire included all eight scales from the SF-36 and measures of nine other generic and disease-specific health concepts. Psychometric tests confirmed the assumptions underlying the construction and scoring of all generic and disease-specific scales. Cross-sectional tests of 'known groups' validity showed that CHC patients scored worse on the generic scales than patients with other chronic conditions and worse than a healthy general population. The generic and disease-specific scale scores were lower in the presence of physical findings of CHC, as hypothesized, but only the physical functioning and bodily pain scales were linked to cirrhosis or extreme alanine aminotransferase (ALT) ratios. This instrument will be useful in studies of health outcome among patients with CHC, a condition whose health burden appears to have been underestimated in studies to date.

Comparison of responses to SF-36 Health Survey questions with one-week and four-week recall periods.

OBJECTIVE: To compare the measurement properties of acute (one-week recall) and standard (four-week recall) versions of SF-36 Health Survey (SF-36) scale scores. DATA SOURCES: SF-36 data collected from 142 participants (60% female, average age 39) in a clinical trial of an asthma medication: 74 patients randomized to the acute form and 68 to the standard. DATA COLLECTION: The SF-36 was self-administered at the time of a clinic visit (before clinical examination) to synchronize with clinical measures of disease severity at three different time points during the clinical trial: -2 weeks (two weeks before randomization to treatment), baseline (week 0 or randomization), and +4 weeks (four weeks after baseline). PRINCIPAL FINDINGS: The acute form yielded high-quality data; scales conformed to the assumptions of the summated ratings method used to score the standard SF-36; and scales had good distributional properties, were reliable, and had a factor content similar to the standard. The data indicated that while the acute form was more sensitive than the standard to change in health status associated with changes in acute symptoms, acute scale scores may not be comparable to national norms based on the standard, particularly for those scales that assess frequency of health events during a specified time period. CONCLUSIONS: Results support the use of the acute form in its intended applications; however, further research is required to document the generalizability of greater sensitivity of the acute form to recent changes in health and to explore whether norms based on the standard can be used to interpret the acute scale scores.

Differences in 4-year health outcomes for elderly and poor, chronically ill patients treated in HMO and fee-for-service systems. Results from the Medical Outcomes Study.

OBJECTIVE: To compare physical and mental health outcomes of chronically ill adults, including elderly and poor subgroups, treated in health maintenance organization (HMO) and fee-for-service (FFS) systems. STUDY DESIGN: A 4-year observational study of 2235 patients (18 to 97 years of age) with hypertension, non-insulin-dependent diabetes mellitus (NIDDM), recent acute myocardial infarction, congestive heart failure, and depressive disorder sampled from HMO and FFS systems in 1986 and followed up through 1990. Those aged 65 years and older covered under Medicare and low-income patients (200% of poverty) were analyzed separately. SETTING AND PARTICIPANTS: Offices of physicians practicing family medicine, internal medicine, endocrinology, cardiology, and psychiatry, in HMO and FFS systems of care. Types of practices included both prepaid group (72% of patients) and independent practice association (28%) types of HMOs, large multispecialty groups, and solo or small, single-specialty practices in Boston, Mass, Chicago, Ill, and Los Angeles, Calif. OUTCOME MEASURES: Differences between initial and 4-year follow-up scores of summary physical and mental health scales from the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) for all patients and practice settings. RESULTS: On average, physical health declined and mental health remained stable during the 4-year follow-up period, with physical declines larger for the elderly than for the nonelderly (P<.001). In comparisons between HMO and FFS systems, physical and mental health outcomes did not differ for the average patient; however, they did differ for subgroups of the population differing in age and poverty status. For elderly patients (those aged 65 years and older) treated under Medicare, declines in physical health were more common in HMOs than in FFS plans (54% vs 28%; P<.001). In 1 site, mental health outcomes were better (P<.05) for elderly patients in HMOs relative to FFS but not in 2 other sites. For patients differing in poverty status, opposite patterns of physical health (P<.05) and for mental health (P<.001) outcomes were observed across systems; outcomes favored FFS over HMOs for the poverty group and favored HMOs over FFS for the nonpoverty group. CONCLUSIONS: During the study period, elderly and poor chronically ill patients had worse physical health outcomes in HMOs than in FFS systems; mental health outcomes varied by study site and patient characteristics. Current health care plans should carefully monitor the health outcomes of these vulnerable subgroups.

Comparison of methods for the scoring and statistical analysis of SF-36 health profile and summary measures: summary of results from the Medical Outcomes Study.

Physical component summary (PCS) and mental component summary (MCS) measures make it possible to reduce the number of statistical comparisons and thereby the role of chance in testing hypotheses about health outcomes. To test their usefulness relative to a profile of eight scores, results were compared across 16 tests involving patients (N = 1,440) participating in the Medical Outcomes Study. Comparisons were made between groups known to differ at a point in time or to change over time in terms of age, diagnosis, severity of disease, comorbid conditions, acute symptoms, self-reported changes in health, and recovery from clinical depression. The relative validity (RV) of each measure was estimated by a comparison of statistical results with those for the best scales in the same tests. Differences in RV among scales from the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) were consistent with those in previous studies. One or both of the summary measures were significant for 14 of 15 differences detected in multivariate analyses of profiles and detected differences missed by the profile in one test. Relative validity coefficients ranged from .20 to .94 (median, .79) for PCS in tests involving physical criteria and from .93 to 1.45 (median, 1.02) for MCS in tests involving mental criteria. The MCS was superior to the best SF-36 scale in three of four tests involving mental health. Results suggest that the two summary measures may be useful in most studies and that their empiric validity, relative to the best SF-36 scale, will depend on the application. Surveys offering the option of analyzing both a profile and psychometrically based summary measures have an advantage over those that do not.