Responsiveness of the SF-36 and the Health Assessment Questionnaire Disability Index in a systemic sclerosis clinical trial

OBJECTIVE: This study compares the responsiveness to change of the Medical Outcomes Study Short Form Health Survey (SF-36), a measure of health related quality of life (HRQOL), and the Health Assessment Questionnaire Disability Index (HAQ-DI), a function instrument, in a randomized clinical trial for treatment of systemic sclerosis (SSc). METHODS: A phase 2/3, multicenter, prospective, placebo controlled trial was conducted to evaluate human recombinant relaxin treatment in patients with diffuse SSc over 24 weeks. At baseline, subjects had stable, moderately severe, diffuse SSc of disease duration < or = 5 years, modified Rodnan skin score > or = 20, serum creatinine < 2.0 mg/dl, percentage forced vital capacity (% FVC) predicted > or = 50%, and % DLCO predicted > or = 40% and were not receiving concomitant disease modifying therapies. Internal consistency reliability of multi-item scales was estimated using Cronbach's alpha. Responsiveness to change of the SF-36 and HAQ-DI was computed between Weeks 0 and 24. Subjects were classified as unchanged or having a meaningful change in 4 different external measures: Change in (1) skin score > or = 30%; (2) % FVC predicted of > or = 15%; (3) self-reported patient global assessment by visual analog scale (VAS) > or = 20%; and (4) physician global assessment by VAS of > or = 20%. Responsiveness indices were computed and Cohen's effect size criteria were used to assess the magnitude of change. RESULTS: A total of 239 patients participated in this trial, with 196 completing the 24 week trial. Cronbach's alpha for the SF-36 scales ranged from 0.76 to 0.93 and for the HAQ-DI ranged from 0.69 to 0.91 (good to excellent). The SF-36 had a larger magnitude of responsiveness in overall disease (patient and physician global assessment) compared to the HAQ-DI, while the HAQ-DI had a larger magnitude of responsiveness in clinical measures (i.e., change in skin score and % FVC predicted) than the SF-36. CONCLUSION: These data support inclusion of both the SF-36 and HAQ-DI as outcome measures in future clinical trials of diffuse SSc.     

Validation of the Chinese Health Questionnaire (CHQ-12) in community elders

There has been no validated screening instrument for use in non-psychotic illness of the elderly in Taiwan. This study aims to test the validity of the 12-item Chinese Health Questionnaire (CHQ-12) among the elderly in a community study. The CHQ-12 was administrated via reading-out to 222 subjects aged 65 and over from three communities. Psychiatrists using the Geriatric Mental Status Schedule (GMS) assessed psychiatric condition while the diagnosis was made according to the computerized program, AGECAT. Validity indices of the CHQ-12 were calculated, using the Relative Operating Characteristic (ROC) analysis for its optimal cut-off point. Variables hypothesized to affect its performance were assessed. Validity of the CHQ-12 at optimal cut-off point 2/3 were estimated with a sensitivity of 79.7%, a specificity of 83.6%, a positive predictive value of 68.9%, a negative predictive value of 90.0% and an overall misclassification rate of 17.6%, and an estimate of the area under the ROC curve of 0.81. The performance of the CHQ-12 was better in males, in those who were literate, and in those without any physical illness. This study demonstrated that the use of CHQ-12 in the elderly community is as valid as in the general population survey. However, it should be read out by the investigator rather than self-administered due to the high proportion of illiteracy among the Taiwanese elderly.     

Validity and Reliability of the Modified Manchester Health Questionnaire in Assessing Patients With Fecal Incontinence

PURPOSE To date, no measures of fecal incontinence severity or its impact on quality of life have been validated for telephone interview. This study was designed to 1) compare responses of a self-administered and a telephone-administered Fecal Incontinence Severity Index; 2) compare a self-administered Fecal Incontinence Quality of Life Scale to the Manchester Health Questionnaire after modifying the latter for telephone administration and American English (Modified Manchester Health Questionnaire); 3) assess test-retest reliability of the telephone-administered Modified Manchester Health Questionnaire; and 4) assess the internal consistency of the Modified Manchester Health Questionnaire subscales.METHODS Consecutive, English-speaking, nonpregnant females known to have fecal incontinence were invited to participate. Two validated paper questionnaires accompanied the letter informing them of the study: Fecal Incontinence Severity Index and Fecal Incontinence Quality of Life Scale. Consenting patients were contacted for the initial telephone administration of the Modified Manchester Health Questionnaire, and patients who agreed to continue the study were contacted for a repeat telephone administration of the Modified Manchester Health Questionnaire two to four weeks after completing the first interview.RESULTS Fifty-one females were invited to participate in the study; however, 13 declined or were ineligible. Thirty females, aged 49.3 ± 10.3 years, returned self-administered questionnaires and completed the first telephone interview, and 21 completed a second telephone interview after an average interval of 23 days. The telephone-administered Fecal Incontinence Severity Index scores were significantly lower than those yielded by the self-administered Fecal Incontinence Severity Index, (6.19 vs. 9.85; P < 0.001), but the telephone and written administrations were significantly correlated (r = 0.5; P < 0.02). Correlations between the Modified Manchester Health Questionnaire quality of life subscales and the paper Fecal Incontinence Quality of Life subscales ranged from 0.6 to 0.9 (median, r = 0.81). The correlation between the total score for the Fecal Incontinence Quality of Life and the total score for the Modified Manchester Health Questionnaire quality of life scales was 0.93 (P < 0.001). Test-retest reliability for the eight Modified Manchester Health Questionnaire subscales ranged from 0.55 to 0.98 (median, r = 0.83), and test-retest reliability for the two telephone administrations of the Fecal Incontinence Severity Index was r = 0.75. Cronbachs alpha for the eight Modified Manchester Health Questionnaire subscales ranged from 0.79 to 0.92 (median, alpha = 0.85).CONCLUSIONS Telephone-administered versions of the Modified Manchester Health Questionnaire showed good-to-excellent validity, internal consistency, and test-retest reliability. The telephone-administered Fecal Incontinence Severity Index yielded lower severity scores than the written Fecal Incontinence Severity Index; however, the difference (3.66 units) was not clinically significant.Supported by Pelvic Floor Disorders Network.Supported by NICHD grants U10 HD41249, U10 HD41268, U10 HD41248, U10 HD41250, U10 HD41261, U10 HD41263, U10 HD41269, U10 HD41267.Presented at the American Urogynecologic Society, Hollywood, Florida, September 11 to 13, 2003.Reprints are not available.     

Translating clinical trial results into practice: the effect of an AIDS clinical trial on prescribed antiretroviral therapy for HIV-infected pregnant women.

BACKGROUND: The success of Pediatric AIDS Clinical Trials Group (PACTG) Protocol 076 in preventing vertical HIV transmission prompted intensive efforts to inform lay-persons and professionals about the trial's results. OBJECTIVE: To explore community responsiveness to these efforts by assessing temporal, maternal, and health care factors associated with prescribed antiretroviral therapy before and after PACTG Protocol 076. DESIGN: Retrospective cohort study. SETTING: New York State Medicaid program. PATIENTS: 2607 HIV-infected women who delivered a living child between January 1993 and September 1996. MEASUREMENTS: Adjusted odds of being prescribed antiretroviral treatment in the second or third trimester for women who delivered in period 1 (during the trial [January 1993 to February 1994]), period 2 (after the trial's end and announcement of the results to publication of the results [March 1994 to November 1994]), and period 3 (after publication of the trial results [December 1994 to September 1996]). RESULTS: The adjusted odds of being prescribed antiretroviral therapy increased 21% per month in period 2 and decreased to 3% per month in period 3. In all time periods, the adjusted odds of being prescribed antiretroviral therapy were at least 60% greater (P < 0.05) for women who were treated at an institution that performed HIV clinical trials, received HIV-focused ambulatory care, or had adequate prenatal care visits. After the trial, women receiving methadone treatment had at least twofold (95% CI, 1.5- to 4.3-fold) greater adjusted odds of being prescribed antiretroviral therapy than women who did not take any illicit drugs. Latin-American women, older women, and women born in the United States had greater adjusted odds (P < 0.05) of being prescribed treatment in period 3. CONCLUSION: Community practice responded rapidly to efforts to disseminate the results of PACTG Protocol 076; however, the absolute increase in prescribed therapy was greatest for women who had adequate prenatal visits or were receiving HIV-focused care, care at a site that performed clinical trials, or methadone therapy.     

Health utility measurement for people living with HIV/AIDS under combined antiretroviral therapy: A comparison of EQ-5D-5L and SF-6D

We compared the discriminative validity, agreement and sensitivity of EQ-5D-5L and SF-6D utility scores in people living with HIV/AIDS (PLWHIV). We conducted a cross-sectional survey among PLWHIV aged more than 18 years old in 9 municipalities in Yunnan Province, China. A convenience sample was enrolled. We administered the SF-12 and EQ-5D-5L to measure health-related quality of life. The utility index of the SF-6D was derived from the SF-12. We calculate correlation coefficients to evaluate the relationship and agreement of 2 instruments. To evaluate the homogeneity of the EQ-5D-5L and SF-6D, intraclass correlation coefficients, scatter plots, and Bland–Altman plots were computed and drawn. We also used receiver operating characteristic curves to compare the discriminative properties and sensitivity of the econometric index. A total of 1797 respondents, with a mean age of 45.6 ± 11.7 years, was interviewed. The distribution of EQ-5D-5L scores skewed towards full health with a skewness of −3.316. The overall correlation between EQ-5D-5L and SF-6D index scores was 0.46 (P < .001). The association of the 2 scales appeared stronger at the upper end. An intraclass correlation coefficient of 0.59 between the EQ-5D-5L and SF-6D meant a moderate correlation and indicated general agreement. The Bland–Altman plot displayed the same results as the scatter plot. The receiver operating characteristic curve showed that the AUC for the SF-6D was 0.776 (95% CI: 0.757, 0.796) and that for the EQ-5D-5L was 0.732 (95% CI: 0.712, 0.752) by the PCS-12, and it was 0.782 (95% CI: 0.763, 0.802) for the SF-6D and 0.690 (95% CI: 0.669, 0.711) for the EQ-5D-5L by the MCS-12. Our study demonstrated evidence of the performance of EQ-5D-5L and SF-6D index scores to measure health utility in people living with HIV/AIDS. There were significant differences in their performance. We preferred to apply the SF-6D to measure the health utility of PLWHIV during the combined antiretroviral therapy period. Our study has demonstrated evidence for instrument choice and preference measurements in PLWHIV under combined antiretroviral therapy.     

Controlled trial of clinical utility of serum salicylate monitoring in rheumatoid arthritis

A crossover double-blind controlled trial was performed on 36 patients with rheumatoid arthritis to assess the necessity for serum salicylate monitoring in determining optimal dosage. There was no clinically or statistically significant increase in the clinical improvement of patients associated with serum monitoring but potentially toxic serum levels occurred without tinnitus when serum monitoring was not used.     

Antihypertensive utility of perindopril in a large, general practice-based clinical trial

The authors evaluated, in a community-based open-label trial, the effectiveness and safety of perindopril in 13,220 US hypertensive patients and studied how physicians adhere to hypertension treatment guidelines. Patients received perindopril 4 mg q.d. for 6 weeks. Based on physicians' perception of blood pressure response, the patient was either maintained on 4 mg or the dose was increased to 8 mg for an additional 6 weeks. From baseline to week 12, the mean sitting blood pressure significantly declined from 156.9/94.5 mm Hg to 139.2/84.0 mm Hg. Further dose titration resulted in a clinically significant reduction in blood pressure in all patients with inadequate response on 4 mg at week 6. Blood pressure control (<140/<90 mm Hg) was achieved at 12 weeks in 48.8% patients. The subpopulation analyses demonstrated that perindopril monotherapy was effective in both men and women, in patients of all ethnicities, and in patients <65 and ≤65 years of age. Perindopril was safe and well tolerated in all hypertensive subgroups including high-risk patients. Physicians were more attuned to controlling diastolic than systolic blood pressure, and their adherence to the treatment guidelines was found to be not optimal.     

Sensitivity of a Dutch Health Assessment Questionnaire in a trial comparing hydroxychloroquine vs. sulphasalazine

To measure health status in Dutch rheumatoid arthritis patients, we have translated and revised the Health Assessment Questionnaire (HAQ) and added questions about psychosocial status from the Arthritis Impact Measurement Scales (AIMS). The resultant questionnaire turned out to be reproducible and valid. In a double-blind trial comparing Hydroxychloroquine and Sulphasalazine, after 48 weeks the Physical Disability score showed a significant difference in favour of the Sulphasalazine group, reflecting the smaller deterioration in radiographic damage in this group. Thus the Physical Disability part of the questionnaire is sensitive to difference between two slow-acting anti-rheumatic drugs.     

Assessing disability in patients with rheumatoid arthritis. Use of a Swedish version of the Stanford Health Assessment Questionnaire

The validity and reliability under Swedish conditions of a translated and slightly modified version of the Stanford Health Assessment Questionnaire (HAQ), referred to here as the ADL questionnaire, was studied. Sixty-four patients with definite/classical rheumatoid arthritis (RA) participated in the major part of the investigation. In addition, inter-observer reliability was studied in the testing of 15 other patients with RA. The questionnaire was filled in by the patients twice (ADL Tests 1 and 2) with a one-week interval between. A physiotherapist or occupational therapist also assessed each of the patients on a sample of ADL functions (ADL Test 3). Joint mobility, grip-strength, pain, Ritchie index and ESR were likewise checked. Results indicated inter-observer reliability to be high for the ADL (r(S) = 0.98), for joint mobility (r(S) = 0.86), and for the Ritchie index (r(S) = 0.83). The test-retest reliability for the ADL questionnaire which the patients filled in (Tests 1 and 2) was high r(S) = 0.91. Results of the ADL questionnaires the patients completed were found to correlate fairly closely with the observations of the therapists, r(S) = 0.71. The validity of the scoring system was found to be sufficient, using Ward's cluster analysis for comparing the original HAQ scores with scores on all the questions included in the questionnaire. Thus, the translated and somewhat modified version of the ADL questionnaire studied here appears to possess a high degree of reliability and validity in assessing patients with RA.     

Benchmarking: the five year outcome of rheumatoid arthritis assessed using a pain score, the Health Assessment Questionnaire, and the Short Form-36 (SF-36) in a community and a clinic based sample

BACKGROUND: Treatment, and therefore outcome, of rheumatoid arthritis (RA) will improve in the next few years. However, improvement in outcome can only be judged against the probability of certain outcomes with current conventional treatment. AIM: To document the five year outcome of RA in the late 1990s. SETTING: Norfolk Arthritis Register (NOAR). DESIGN: Longitudinal observational cohort study. METHODS: 318 patients with recent onset inflammatory polyarthritis recruited by NOAR in 1990-91 completed five years of follow up. Four groups were assessed: the whole cohort, all those referred to hospital, those who satisfied criteria for RA at baseline, and those referred to hospital who satisfied criteria for RA at baseline. Outcome was assessed with a visual analogue scale for pain, the Health Assessment Questionnaire (HAQ), and the Short Form-36 (SF-36). RESULTS: Of the RA hospital attenders, 50% had a visual analogue scale pain score of 5 cm or less and an HAQ score of 1.125 or less. SF-36 scores were reduced in all domains. Results are presented as cumulative percentages. CONCLUSIONS: These results can be used for comparison and to set targets for improvement.     

Diagnostic errors using the Short Portable Mental Status Questionnaire with a mixed clinical population

The validity of the Short Portable Mental Status Questionnaire (SPMSQ) was evaluated using two criteria: clinical diagnosis and neuropsychological diagnosis. The 40 study participants represented a mixed clinical sample of neurologic and psychiatric patients, all of whom were or had been inpatients. Laboratory data (CT, EEG, etc.) were available for 45% of the patients. Neuropsychological diagnosis of organic impairment was based on an extensive test battery. The SPMSQ did not significantly relate to either clinical or neuropsychological diagnosis. It is recommended that a "normal" score on the SPMSQ be regarded as nonspecific regarding organic cognitive impairment rather than suggestive of normal brain functioning.     

Changes in Health Assessment Questionnaire disability scores over five years in patients with rheumatoid arthritis compared with the general population

OBJECTIVE: To analyze longitudinal data over 5 years for changes in Health Assessment Questionnaire (HAQ) scores in patients with rheumatoid arthritis (RA) and age- and sex-matched controls from the general population. METHODS: In 2000 and 2005, identical self-report questionnaires were mailed to a cohort of patients with RA and control cohort from the community. The questionnaire included the HAQ, which was used to assess functional status. Changes in HAQ scores over 5 years were analyzed. RESULTS: In 2000, 73% of 1,495 patients with RA and 77% of 2,000 general population controls responded to the questionnaire. In 2005, 84% of 2,022 patients with RA and 77% of 1,817 controls responded. A total of 863 patients with RA and 1,176 community controls responded in both 2000 and 2005 and were included in the analyses. Mean baseline HAQ scores were significantly higher in patients with RA than in controls (0.71 versus 0.17; P < 0.001). Over 5 years, the HAQ scores increased by 0.01 units per year in both the RA cohort and the community population; in both cohorts, the net change was primarily attributable to individuals over age 70 years. Changes in HAQ scores were similar in patients and controls who had low HAQ scores at baseline. Female patients with baseline HAQ scores of >or=0.5 had less potential for improvement than did controls. Among subjects in both groups who had HAQ scores >2, death was a common outcome over the next 5 years. CONCLUSION: Currently, progression of functional disability among patients with RA and among persons in the general population is largely explained by the aging process. Our results showing stable function scores over 5 years in most patients with RA who are younger than age 70 years provide further evidence of improved status of RA patients today compared with the major declines observed in previous decades.     

The rheumatoid factor: an analysis of clinical utility

The rheumatoid factor (RF) is a frequently ordered diagnostic test, yet it possesses significant limitations in sensitivity, specificity, and predictive value. Recognition of these limitations could improve the test's utility by encouraging more selective test ordering and more circumspect interpretation of test results. An analysis of 563 requests for RF from a teaching hospital revealed a positive predictive value of only 24% to 34%. The RF performs best under conditions of moderate pretest likelihood of rheumatoid arthritis, and otherwise has rather limited clinical utility.     

上海市男男同性性传播AIDS病人的临床流行病学研究

目的通过对上海艾滋病(AIDS)抗反转录病毒治疗(ART)病人的流行病学研究,为国家艾滋病防治专家提供基本信息,针对不同地区因地制宜采取侧重点不同的防控措施。方法采集662例男性病人的相关信息,分为同性性传播组和非同性性传播组进行相关数据的统计学分析。结果通过同性性传播感染的男性病人为318例(48.04%),且占男性病人的比例由2005年的38.71%上升至2010年的57.14%。开始ART时的年龄分别为同性性传播组(36.14±11.05)岁,非同性性传播组(45.80±11.08)岁,差异有统计学意义(P<0.01)。婚姻状况方面前者未婚为198例(62.26%),后者为56例(16.28%),差异有统计学意义(P<0.01)。两组已婚的病人中均有配偶感染的情况。在学历方面,两组差异有统计学意义(P<0.01),具有大专及以上学历的病人前者137例(43.08%),后者36例(10.47%)。在病人发现感染至治疗时间间隔方面,两组分别为(10.43±15.83)个月和(10.76±17.80)个月,差异无统计学意义(P=0.802)。结论因同性性传播途径感染的病人的比例迅速上升,均为年轻且具有较高学历的国家有用人才,应引起各参与防治工作人员的重视,采取更有效的方式和模式来减少未采取保护措施的肛交(UAI)的发生。男男同性恋尚不能得到社会的承认,有些人不得不结婚生子,因此在关注男男同性恋的同时,也应该关注其婚姻状况,以及其配偶可能感染的问题。     

The relationship between health perception and utility in heart failure patients in a clinical trial: results from an OVERTURE substudy

BACKGROUND: Cost-effectiveness analyses should be based on incremental years of life gained adjusted with a health status measure known as a utility. Measuring utilities for all subjects in a large-scale randomized trial, however, would be prohibitively cumbersome. We therefore sought to estimate utilities for all subjects from results obtained in a subset of patients. METHODS AND RESULTS: We studied a subset of patients enrolled in a randomized trial of omapatrilat for the treatment of heart failure. Survey instruments (a time trade-off questionnaire, a visual analog scale [VAS] score of overall health perception, and the Duke Activity Status Index [DASI]) were administered to patients by mail and by telephone interviews. There was a significant (P <.0001) relationship between VAS score and utility described by the power function u=1-(1-v)q, where q=2.17 (95% CI 1.76 to 2.58). There was a significant positive correlation (r=.17, P <.04) between the DASI and utility, and a significant negative correlation (r=-.26, P <.001) between utility and New York Heart Association functional class. CONCLUSION: There is a significant relationship between the relatively easily obtainable health perception score by VAS with the more complex utility by time tradeoff for a subset of patients in a multicenter randomized clinical trial. This relationship may be helpful in examining the cost-effectiveness of new treatments for heart failure.