Responsiveness of self-reported and objective measures of disease severity in carpal tunnel syndrome

Responsiveness, the ability to detect meaningful clinical change, is a critical attribute of instruments used to evaluate outcomes of treatments. The authors hypothesized that self-administered symptom severity and functional status questionnaires are more responsive to clinical improvement after carpal tunnel release than traditional physical examination measures of strength and sensibility. Data were obtained from a randomized clinical trial of endoscopic versus open carpal tunnel release conducted in four university medical centers. Patients were evaluated before surgery and 3 months after surgery. Seventy-four patients indicating that they were more than 80% satisfied with the results of surgery were assumed to have clinically meaningful improvement and were the focus of the analysis. Evaluations included questionnaires assessing symptom severity, functional status, and activities of daily living as well as measurement of grip, pinch, and abductor pollicus brevis strength, and 2-point discrimination and Semmes-Weinstein pressure sensibility. Responsiveness was calculated with the standardized response mean (mean change/standard deviation of change) as well as the effect size (mean change/standard deviation of baseline values). The symptom severity scale was four times as responsive, and the functional status and activities of daily living scales were twice as responsive, as the measures of strength and sensibility. Self-administered symptom severity and functional status scales are much more responsive to clinical improvement than measures of neuromuscular impairment and should severe as primary outcomes in clinical studies of therapy for carpal tunnel syndrome.     

Prognostic value of a hand symptom diagram in surgery for carpal tunnel syndrome

OBJECTIVE: To evaluate symptom patterns on a hand diagram as predictors of surgical outcome in carpal tunnel syndrome (CTS). METHODS: 202 patients with CTS enrolled in a prospective, community based cohort study in Maine completed a hand symptom diagram before surgery and at 6 month followup. They were asked to mark on the hand diagram the location of 3 symptoms: pain, numbness/tingling (NT), and "other" symptoms. The diagram was first divided into 6 regions following a standardized procedure. For the 6 regions, symptom patterns were identified separately for each of the 3 symptoms. Outcomes 6 months after surgery were expressed as the percentage of change on the Symptom Severity Scale and Function Status Scale of the Carpal Tunnel Syndrome Assessment Questionnaire, and the satisfaction with the results of the surgery. RESULTS: Several distinct symptom patterns were associated with the 3 principal outcomes in univariate and multivariate analysis. In linear regression models controlling for the baseline severity of symptoms and function, as well as other predictors, the hand symptom pattern variables accounted for 30, 14, and 24%, respectively, of the total explained variance in satisfaction, symptom severity, and functional status. Patients receiving Workers' Compensation (37% of the cohort) had more wrist pain and NT of the arm, and less pain involving the arm and upper palm. This group also had worse outcomes and were less satisfied with surgery. Drawing expansion was associated with a low score on the SF-36 mental health subscale. However, psychological impairment was not associated with a worse outcome. CONCLUSION: Symptom patterns identified preoperatively with a hand symptom diagram help to predict the outcome of carpal tunnel release.     

Pain coping strategies in osteoarthritis patients.

The present study investigated the relation of pain coping strategies to pain, health status, and psychological distress in a group of osteoarthritis patients with chronic knee pain. Fifty-one patients completed the Coping Strategies Questionnaire (CSQ), the McGill Pain Questionnaire, the Arthritis Impact Measurement Scale (AIMS), and the Symptom Checklist-90 Revised (SCL-90R). Medical status variables included roentgenograph (x-ray) findings, obesity measures, disability status, and chronicity of pain. Factor analysis of the CSQ revealed two factors (Coping Attempts, Pain Control and Rational Thinking) that accounted for 60% of the variance in CSQ responses. Regression analyses controlling for demographic and medical variables identified the Pain Control and Rational Thinking factor as a significant predictor of the outcome measures. Patients scoring high on this factor had lower pain levels, better health status, and lower levels of psychological distress. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

One week triple therapy with omeprazole, clarithromycin and tinidazole for Helicobacter pylori: differing efficacy in previously treated and untreated patients

OBJECTIVE: To assess the validity of the revised and expanded version of the Arthritis Impact Measurement Scales (AIMS2) in patients with psoriatic arthritis (PsA). METHODS: The AIMS2 was administered to all patients attending our Psoriatic Arthritis Clinic between June and December 1993. Clinical and radiological assessments were performed during the clinic visits. RESULTS: The patient population included 124 patients, 75 men and 49 women with a mean age of 48.4 years and a mean arthritis duration of 14.6 years. Most of the physical function scales as well as the pain and work scales were moderately to highly correlated with clinical measures of function (r = 0.27-0.64) and disease activity (r = 0.28-0.50), but they were not correlated with measures of disease severity. The psychosocial scales were poorly correlated with all clinical measures. CONCLUSION: Our data suggest that, like the original AIMS, the AIMS2 is valid for use as an adjunct outcome measure for clinical trials in PsA.     

Changes in health status of elderly patients following hip replacement surgery

This study investigated changes in health status following a total hip replacement among a convenience sample of 22 male and 23 female patients, all of whom had been suffering from hip dysfunction and associated arthritic pain and impaired mobility. Subjects were pretested in an orthopedic pre-admission clinic with the Arthritis Impact Measurement Scales questionnaire and were posttested with the same instrument 3 1/2 months after the initial contact and subsequent to hip replacement surgery. Analysis of pretest and posttest mean differences showed significant improvement in scores for pain and physical activity. No significant changes were demonstrated in the psychological and social domains of health status.     

Health assessment in the rheumatic diseases of childhood

Assessment of children and adults with rheumatic diseases, both in clinical practice and controlled clinical trials in rheumatology, has traditionally focused on the measurement of disease activity. More recently emphasis has been placed on the need to incorporate estimates of physical, social, and mental functioning into health assessment. Thus there has been a tremendous growth in the development of measurement instruments that evaluate health status, functional status, disability, and quality of life. This type of measurement has become essential, particularly for clinical trials in adults with rheumatic diseases, for which the AIMS (Arthritis Impact Measurement Scales), the HAQ (Health Assessment Questionnaire), and the MACTAR (McMaster-Toronto arthritis) patient preference questionnaire have been the most widely used. In the past few years, similar measures have been developed for application in children with rheumatic diseases. These include the CHAIMS (Childhood Arthritis Impact Measurement Scales), the CHAQ (Childhood Health Assessment Questionnaire), the JAFAR (Juvenile Arthritis Functional Assessment Report), the JASI (Juvenile Arthritis Self-report Index), the JAQQ (Juvenile Arthritis Quality of Life Questionnaire), and the CAHP (Childhood Arthritis Health Profile). In this review, the development and measurement properties of these childhood instruments are discussed, with particular emphasis on their potential roles as supported by recent literature.     

Comparison of the Health Assessment Questionnaire and Arthritis Impact Measurement Scale in patients with psoriatic arthritis

OBJECTIVE: To determine which of two instruments, the Health Assessment Questionnaire (HAQ) and the Arthritis Impact Measurement Scales (AIMS), was more closely correlated with the main parameters reflecting activity and severity of psoriatic arthritis. METHODS: Both instruments were administered to 72 consecutive patients with psoriatic arthritis. RESULTS: Global HAQ and AIMS scores were closely correlated with each other (rs = 0.747; P < 0.00001). AIMS physical function scales--namely physical activity, dexterity, social activity and activities of daily living--were moderately or closely correlated with the main clinical disease activity parameters, most notably morning stiffness of axial joints (rs = 0.271-0.551). Scales measuring psychological status yielded weaker correlations with disease activity parameters (rs = 0.241-0.277) and were also correlated with the visual analog scale score for skin lesion severity. Morning stiffness of peripheral joints was correlated only with two AIMS scales, namely pain (rs = 0.532) and activities of daily living (rs = 0.303). Severity of radiological damage of peripheral and axial joints was most closely correlated with the scales of physical function, most notably physical activity. The global and scale HAQ scores showed moderate to close correlations with the main clinical disease activity parameters, most notably morning stiffness of axial joints. The global HAQ score was also correlated with radiological carpal involvement and with the radiological severity of peripheral joint involvement, whereas only the arising and hygiene scales were (moderately) correlated with the radiological severity of spinal involvement. CONCLUSION: Although both the HAQ and the AIMS were useful in assessing health status in psoriatic arthritis patients, only the AIMS captured some of the effects of the skin lesions. Our data also suggest that the AIMS may be more effective than the HAQ for evaluating the effect of radiological lesions produced by psoriatic arthritis.     

Mucosa-associated bacterial flora of the human colon

Little is known about factors that predict return to work following carpal tunnel release. Patients enrolled in a prospective, community-based study of carpal tunnel syndrome in Maine were evaluated with standardized questionnaires preoperatively and 6 months following carpal tunnel release. Univariate and multivariate analyses were performed to identify baseline factors associated with work disability 6 months following surgery. Thirty-one of 135 patients (23%) were out of work because of CTS 6 months following surgery. The predominant preoperative variables associated with work absence due to CTS 6 months postoperatively in logistic regression analyses were Workers' Compensation, work absence preoperatively, and worse mental health status (p < or = 0.01 for each). In analyses that considered postoperative as well as preoperative variables, persistence of symptoms following surgery was the most striking predictor of failure to return to work due to CTS (p < 0.0001). Preoperative correlates of less complete relief of symptoms in multivariate models included involvement of an attorney, milder preoperative symptom severity, preoperative work absence (p < 0.005 for each) and exposure to hand intensive work (p = 0.04). These data indicate that economic and psychosocial variables have a strong influence upon both return to work and the extent of symptom relief 6 months following surgery for carpal tunnel syndrome.     

Measurement properties of a self-administered outcome measure in lumbar spinal stenosis

STUDY DESIGN: The measurement properties and validity of a newly developed patient questionnaire for the assessment of patients with lumbar spinal stenosis was tested in an ongoing prospective multicenter observational study of patients undergoing decompressive surgery in three teaching hospitals. OBJECTIVE: The goal of the study was to develop a short, self-administered questionnaire on symptom severity, physical functional status, and patient satisfaction. SUMMARY OF BACKGROUND DATA: The measure is intended to complement existing generic measures of spinal-related disability and health status. The questionnaire includes three scales with seven questions on symptom severity, five on physical function, and six on satisfaction. METHODS: The internal consistency of the scales was assessed with Cronbach's coefficient alpha on cross-sectional data from 193 patients before surgery. The test-retest reliability was assessed on data from a random sample of 23 patients using Spearman's rank correlation coefficient. The responsiveness was assessed on 130 patients with 6-month follow-up data using the standardized response mean. RESULTS: The test-retest reliability of the scales ranged from 0.82 to 0.96, the internal consistency from 0.64 to 0.92, and the responsiveness from 0.96 to 1.07. The direction, statistical significance, and strength of hypothesized relationships with external criteria were as expected. CONCLUSIONS: This short self-administered spinal stenosis measure is reproducible, internally consistent, valid, and highly responsive. It can be used to complement generic instruments in outcome assessment of patients with lumbar spinal stenosis.     

The incidence and severity of rheumatoid arthritis, results from a county register in Oslo, Norway

OBJECTIVE: To examine the incidence of rheumatoid arthritis (RA) in the community of Oslo, Norway; and to link the incidence to measures of disease severity. METHODS: A register for RA in the county of Oslo was validated to be 85% complete for patients between 20 and 79 years of age. The incidence of RA was calculated from this register for patients with disease onset 1988-1993 (n=550). Data on health related quality of life [Modified Health Assessment Questionnaire (MHAQ), Arthritis Impact Measurement Scale 2 (AIMS2), pain, fatigue] were obtained from a postal survey (response rate 73%). RESULTS: The overall annual incidence of RA over a 6 year period was 25.7/100,000 (females 36.7, males 13.8). The incidence increased with age, from 7.8 in the age group 20-29 to 61.0 between 70 and 79 years. After 5 year followup a clinically important effect on physical function (MHAQ > 1.5) was seen in 38% of the patients, on social functioning (AIMS2 social > 4) in 50%, on mental distress (AIMS2 affect > 4) in 27%, on pain (VAS > 40 mm) in 35%, and on fatigue (VAS > 40 mm) in 41%. CONCLUSION: The incidence of RA was 25.7/100,000 in the population of Oslo. After 5 years, 40-50% had clinically important changes in health status. The annual disease incidence with clinically important effect on physical function after 5 years was 10/100,000 individuals at risk.     

Longitudinal relationships among pain, sleep problems, and depression in rheumatoid arthritis.

Evaluated the relationship between pain and sleep problems, and the role of pain and sleep problems in depression, in a sample of 242 patients who had been diagnosed with definite or classical rheumatoid arthritis (RA). Patients completed the Pain scale of the Arthritis Impact Measurement Scales, the Center for Epidemiological Studies Depression Scale, and self-reports of sleep disturbance at 2 data waves over a 2-yr interval. Cross-sectional multiple regression analysis revealed that the sleep problems variable was independently associated with depression at Time 1. Longitudinal multiple regression analyses demonstrated that prior pain predicted subsequent adverse changes in sleep problems, whereas sleep problems did not affect pain over time, and prior pain and the interaction of high pain and high sleep problems were independently associated with depression from Time 1 to Time 2. These data suggest that pain may exacerbate sleeping difficulty in RA patients and that both may contribute to depression over time. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

A bout of resistance exercise increases urinary calcium independently of osteoclastic activation in men

Outcome after carpal tunnel surgery was studied retrospectively in 32 patients with peripheral neuropathy and carpal tunnel syndrome. Nocturnal paresthesias were almost universally relieved, followed in order of responsiveness by pain, numbness, and weakness. Twenty-five of 28 patients said they would have the surgery again if the outcome were the same. Patients with carpal tunnel syndrome and peripheral neuropathy benefit from surgical treatment of carpal tunnel syndrome.     

Outcome measures for low back pain research. A proposal for standardized use

STUDY DESIGN: An international group of back pain researchers considered recommendations for standardized measures in clinical outcomes research in patients with back pain. OBJECTIVES: To promote more standardization of outcome measurement in clinical trials and other types of outcomes research, including meta-analyses, cost-effectiveness analyses, and multicenter studies. SUMMARY OF BACKGROUND DATA: Better standardization of outcome measurement would facilitate comparison of results among studies, and more complete reporting of relevant outcomes. Because back pain is rarely fatal or completely cured, outcome assessment is complex and involves multiple dimensions. These include symptoms, function, general well-being, work disability, and satisfaction with care. METHODS: The panel considered several factors in recommending a standard battery of outcome measures. These included reliability, validity, responsiveness, and practicality of the measures. In addition, compatibility with widely used and promoted batteries such, as the American Academy of Orthopaedic Surgeons Lumbar Cluster were considered to minimize the need for changes when these instruments are used. RESULTS: First, a six-item set was proposed, which is sufficiently brief that it could be used in routine care settings for quality improvement and for research purposes. An expanded outcome set, which would provide more precise measurement for research purposes, includes measures of severity and frequency of symptoms, either the Roland or the Oswestry Disability Scale, either the SF-12 or the EuroQol measure of general health status, a question about satisfaction with symptoms, three types of "disability days," and an optional single item on overall satisfaction with medical care. CONCLUSION: Standardized measurement of outcomes would facilitate scientific advances in clinical care. A short, 6-item questionnaire and a somewhat expanded, more precise battery of questionnaires can be recommended. Although many considerations support such recommendations, more data on responsiveness and the minimally important change in scores are needed for most of the instruments.     

Health outcome improvements in patients with systemic lupus erythematosus using two telephone counseling interventions

OBJECTIVE: To examine the effectiveness of two telephone intervention strategies for improving the health outcomes of patients with systemic lupus erythematosus (SLE). METHODS: Fifty-eight SLE patients were randomly assigned to receive a 6-month telephone counseling intervention using either a treatment counseling (TC) or symptom monitoring (SM) strategy. Health outcomes were assessed using the Fatigue Severity Scale (FSS) and the Arthritis Impact Measurement Scales 2 (AIMS2). RESULTS: At the 6-month followup, the mean AIMS2 Physical Function scale and AIMS2 Social Support scale scores were significantly improved (P < 0.05) for the TC group compared to the SM groups. The mean FSS score, AIMS2 Affect score, and AIMS2 Pain score were significantly improved (P < 0.05) for both groups. CONCLUSIONS: Telephone interventions, especially using the TC approach, can be effective for improving the functional status of persons with SLE.     

Optic disc morphology in pigmentary glaucoma

To establish the ability of a salvage procedure to restore an independent lifestyle, the SF-36 functional outcome instrument and the pain, mobility, and physical activity subscales of the Arthritis Impact Measurement Scale (AIMS) was used to assess patient function. Nine patients (10 knees) who had undergone arthrodesis for failed total knee arthroplasty were compared with a control group of successful primary total knee arthroplasty patients. Average clinical follow-up was 42 months (minimum: 24 months). For six of the eight SF-36 categories, the average scores for the arthrodesis and arthroplasty groups were similar. The average global scores for the two groups were nearly identical. The arthroplasty patients scored better on the AIMS physical activity and mobility subscales than the arthrodesis group, although the latter group fared better on the pain subscale. Overall, global scores favored the arthroplasty patients. The only subscales to show a statistically significant difference between the arthrodesis and arthroplasty groups were the SF-36 physical functioning and the AIMS physical activity subscales. This pilot study demonstrated the ability of a salvage procedure to allow for an independent lifestyle with minimal complications. Furthermore, despite its popularity, the SF-36 does not appear as sensitive as the AIMS to differences in functional status or health outcomes between total knee arthroplasty and arthrodesis patients.     

Saturated fat intake and the risk of severe hyperemesis gravidarum

We conducted a case-control study to investigate the effect of prepregnancy diet, particularly dietary fats, on the risk of severe hyperemesis gravidarum. Cases were 44 women previously hospitalized at Brigham and Women's Hospital, Boston, MA, for severe hyperemesis gravidarum who delivered a singleton liveborn between January 1, 1993, and December 31, 1995. Controls were 87 women who delivered a singleton liveborn at Brigham and Women's Hospital during the same period and who experienced less than 20 hours of nausea and fewer than three episodes of vomiting over the duration of their pregnancies. Odds ratios were derived from unconditional logistic regression models using data collected via self-administered food frequency questionnaires. Our results indicate that prepregnancy, high daily intake of total fat increases the risk of severe hyperemesis gravidarum (odds ratio = 2.9 for each 25 gm per day increase; 95% confidence interval = 1.4-6.0). This association is driven primarily by saturated fat intake [odds ratio = 5.4 for each 15 gm per day increase (equivalent to one quarter-pound cheeseburger); 95% confidence interval = 2.0-14.8]. We observed no independent effect of total energy intake.     

Spatial learning and hippocampal volume in male deer mice: relations to age, testosterone and adrenal gland weight

Endoscopic carpal tunnel release is a controversial procedure used in the treatment of carpal tunnel syndrome. Although endoscopic carpal tunnel release is associated with less incisional pain and faster recovery time than the open carpal tunnel release, opponents of endoscopic carpal tunnel release suggest that its benefits are outweighed by its higher complication rates from median nerve transection and transient numbness of the fingers. Because of the huge economic and social impact of carpal tunnel syndrome in this country, we performed a cost-effectiveness analysis comparing endoscopic carpal tunnel release and open carpal tunnel release using guidelines established by the Panel on Cost-Effectiveness in Health and Medicine of the U.S. Public Health Service. A decision analytic model was used to measure differences in cost and effectiveness--expressed as quality-adjusted life-years (QALYs)--between endoscopic carpal tunnel release and open carpal tunnel release. The societal perspective was chosen, and probabilities for various outcomes for the two procedures were obtained from published randomized-controlled trials. Cost data were derived from the Medicare Resource-Based Relative Value Units published in the Federal Register. QALYs were obtained from two groups of health care providers using a utility-assessment questionnaire. Using probabilities for various outcomes from the two published randomized-controlled trials comparing endoscopic carpal tunnel release and open carpal tunnel release, we constructed a decision tree to derive both the cost and the QALYs for the two procedures. The incremental cost difference between endoscopic carpal tunnel release and open carpal tunnel release was $46, using Medicare cost and probabilities of various outcomes derived from a study by Brown et al. in 1993. We calculated QALYs for five age groups--25, 35, 45, 55, 65--assuming a life expectancy of 75 years. The marginal effectiveness (QALY of endoscopic carpal tunnel release minus QALY of open carpal tunnel release) ranged from 0.235 QALY for the 25-year-old age group to 0.066 QALY for the 65-year-old age group, giving a cost-effectiveness ratio of $195/QALY and $693/QALY, respectively. When compared with other accepted medical interventions such as breast cancer screening ($4836/QALY) and exercise to prevent coronary heart disease ($13,508/QALY), endoscopic carpal tunnel release seems to be cost-effective. However, our sensitivity analysis indicated that the cost-effectiveness ratio was very sensitive to a major complication such as median nerve injury. For endoscopic carpal tunnel release to be a cost-effective procedure, the incidence of median nerve injury must be one percentage point less for endoscopic carpal tunnel release than for open carpal tunnel release. Based on the data from the randomized-controlled trials, endoscopic carpal tunnel release seems to be a cost-effective procedure; however, before it can be recommended, greater emphasis must be given to the training of surgeons in this new technique, so that major complications such as median nerve injuries can be avoided. In addition, future studies must better define the actual incidence of nerve injuries for both endoscopic carpal tunnel release and open carpal tunnel release in the community setting.     

Performance of the Norwegian SF-36 Health Survey in patients with rheumatoid arthritis. II. A comparison of the SF-36 with disease-specific measures

The performance of the SF-36 was compared with disease-specific health status instruments (Arthritis Impact Measurements Scales [AIMS2], Modified Health Assessment Questionnaire [MHAQ] and visual analogue scales) in 1030 patients with rheumatoid arthritis (mean age 62.3 years, 79% females, mean disease duration 12.9 years, 48% rheumatoid factor positive). The scales performed similarly in known group comparisons (age cohorts, disease severity, disease activity, comorbidity). The SF-36 physical functioning scale correlated -0.69 and -0.73 with the MHAQ and AIMS2 physical scales, respectively. A strong negative correlation was found with the walking and bending subscale of AIMS2 (r = -0.80), a substantial negative correlation with mobility (r = -0.65), and moderate correlations with the scales for hand/finger and arm function (r = -0.52 and r = -0.53). Frequency distributions of scores revealed more skewed distributions of the AIMS2 physical scale and the MHAQ scale than the physical functioning scale of the SF36, whereas the pain and mental health scales were distributed similarly. In conclusion, the SF-36 performs well in patients with rheumatoid arthritis. The physical functioning scale of the SF-36 does not seem to capture all aspects of physical health in rheumatoid arthritis patients, but may be more sensitive than disease-specific measures to low levels of physical disability.     

The perceived stress reactivity scale: Measurement invariance, stability, and validity in three countries.

There is accumulating evidence that individual differences in stress reactivity contribute to the risk for stress-related disease. However, the assessment of stress reactivity remains challenging, and there is a relative lack of questionnaires reliably assessing this construct. We here present the Perceived Stress Reactivity Scale (PSRS), a 23-item questionnaire with 5 subscales and 1 overall scale, based on an existing German-language instrument. Perceived stress reactivity and related constructs were assessed in N = 2,040 participants from the United Kingdom, the United States, and Germany. The 5-factor structure of the PSRS was found to be similar in the 3 countries. In the U.S. sample the questionnaire was applied using 2 modes of administration (paper–pencil and computerized), and measures were repeated after 4 weeks. Measurement invariance analyses demonstrated full invariance across mode of administration and partial invariance across gender and countries. Scale scores differed between countries and genders, with women scoring higher on most scales. Overall, reliability analysis suggested good stability of PSRS scores over a 4-week period, and validation analysis showed expected associations with related constructs such as self-efficacy, neuroticism, chronic stress, and perceived stress. Perceived stress reactivity was also associated with depressive symptoms and sleep. These associations were particularly strong when individuals scoring high on perceived stress reactivity were exposed to chronic stress. In sum, our findings suggest that the PSRS is a useful and easy-to-administer instrument to assess perceived stress reactivity. (PsycINFO Database Record (c) 2011 APA, all rights reserved)     

Functional characterization of a novel type of 1 alpha,25-dihydroxyvitamin D3 response element identified in the mouse c-fos promoter

The measurement characteristics of two asthma symptom diary scales developed for use as health outcome measures in clinical trials of asthma therapy were investigated. A daytime diary scale was designed to capture the frequency and inconvenience of daytime asthma symptoms and their effects on activities, and a nocturnal asthma symptom diary scale was designed to capture awakenings with asthma symptoms. The internal consistency, reliability, validity and responsiveness of both asthma diary scales were assessed in 346 adult asthma patients in two placebo-controlled clinical trials of an investigational asthma therapy, a leukotriene biosynthesis inhibitor. The daytime symptom scale showed sufficient internal consistency (0.90-0.92), and the daytime and nocturnal symptom scales showed sufficient test retest reliability (0.69-0.87). Construct validity was demonstrated by generally moderate-to-strong correlations for changes in the diary scales with changes in other measures of asthma status, such as forced expiratory volume in one second (FEV1), peak expiratory flow (PEF), and puffs of beta-agonist inhaler. Both scales demonstrated significant responsiveness to change in asthma due to therapy in one of the clinical trials. Based on these results, the daytime and nocturnal asthma symptom diary scales show measurement characteristics appropriate for use as asthma outcome measures in clinical trials of asthma therapy.