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Introduction: As yet, there is no patient-assessed, condition-specific instrument for the assessment of health-related quality of life in intermittent claudication. We evaluated the intermittent claudication questionnaire (ICQ) for properties required of a measure of health outcome., Methods and Results: Interviews with patients with intermittent claudication and vascular specialist opinion produced a pool of statements used to itemize a self-completed ICQ. This was piloted in 20 patients for practicality and then administered to 124 stable claudicants. Reliability was assessed through a retest in 63 (51%) patients at 14 days and analysis of Cronbach's alpha for internal consistency. Spearman's correlation coefficient was used to assess construct validity in comparisons between the ICQ and ankle brachial pressure index, treadmill-walking distances, the walking impairment questionnaire, the EuroQol, and the Short Form-36. Responsiveness of the ICQ to changes in health was assessed in 60 patients treated conservatively and 40 patients undergoing angioplasty. The standardized response mean was used to identify the most responsive instrument in the study. A 16-item ICQ with a test-retest intraclass correlation of 0.95 and Cronbach's alpha of.94 was produced. One hundred twenty-one (98%) patients completed the ICQ (mean time, 3.7 minutes). The ICQ correlated better with the EuroQol (r = 0.58) and 7 out of 8 subscales of the Short Form-36 (r = 0.33-0.68) compared with the walking impairment questionnaire. The ICQ demonstrated the largest standardized response mean in relation to health transition compared with the other instruments., Conclusions: The patient-assessed ICQ is a practical, reliable, valid, and responsive measure of patient health-related quality of life in intermittent claudication.

We invited individuals aged above 16 years with a congenital transverse reduction deficiency at and above the wrist born in Norway between 1970 and 2006 to complete the short version of the Disabilities of the Arm, Shoulder and Hand Outcome Measure, the 5-Level EuroQoL-5-Dimension instrument, the RAND 36-Item Short Form Health Survey and a single-item questionnaire on arm function, appearance, pain and prosthesis wear. Of 154 eligible participants, 58 (38%) responded. Their scores were not different from the general population. All had been offered prostheses, and 56 (97%) had been fitted at a median age of 1 year (interquartile range 0–2.8). Of the participants, 37 (64%) were still prosthesis wearers, while 21 (36%) were non-wearers or using gripping devices only. Prosthesis wearers had higher levels of 'vitality' as assessed by the RAND-36 and rated their arm appearance higher, but there were no other score differences, indicating that prosthesis rejection is not associated with worse functional outcomes. Level of evidence: III [ABSTRACT FROM AUTHOR]

Purpose: Standard gamble (SG) is the preferred method of assessing preferences in situations with uncertainty and risk, which makes it relevant to patients considered for aortic valve replacement (AVR). The present study assesses SG preferences in patients with severe aortic stenosis (AS).Methods: All patients >18 years old with severe AS referred for AVR to our institution were invited to enroll in the study. The SG was administered by a clinical research nurse. The SF-36, EQ-5D 3L, Hospital Anxiety and Depression Scale (HADS), and AS symptoms were administered by self-completed questionnaire. We hypothesized that SG utilities would have low-to-moderate correlations with physical and mental aspects of health based on our pathophysiological understanding of severe AS. No correlations were expected with echocardiographic measures of the aortic valve.Results: The response rate for SG was 98 %. SG moderately correlated with physical aspects of SF-36 (PCS, role-physical, vitality), health transition, AS symptoms, and EQ-VAS (ρ S = 0.31-0.39, p < 0.001) and had low correlation with mental aspects of SF-36 and EQ-5D (ρ S = 0.17-0.28, p < 0.001). No correlation was found between SG and HADS, echocardiographic measures, age, gender, or education level (ρ S = 0.01-0.06).Conclusions: SG is an acceptable and feasible method of assessing preferences in patients with severe AS that has evidence for validity. The inclusion of uncertainty lends the SG face validity in this population as a direct approach to assessing preferences and basis for QALY calculations. [ABSTRACT FROM AUTHOR]

Objective. To determine the responsiveness and minimal important change (MIC) of Evaluation of Ankylosing Spondylitis Quality of Life (EASi-QoL), a reliable and valid patient-reported measure of AS-specific quality of life with four domains: physical function (PF), disease activity (DA), emotional well-being (EWB) and social participation (SP).Methods. A total of 1000 UK AS patients received a postal questionnaire including EASi-QoL. Comparative responsiveness of EASi-QoL was assessed against measures reflecting similar health domains in patients self-reporting an improvement in their AS-specific health at 6 months on a health transition question. Effect size (ES) statistics were calculated for all measures and MIC was determined for EASi-QoL. Comparative responsiveness was determined in a randomized trial of AS patients receiving etanercept (ETN) 50 mg weekly or SSZ 3 g daily.Results. Of 470 patients, 80 responding at 6 months reported health improvement. Responsiveness (ES) for EASi-QoL domains was superior or similar to comparator measures: DA 0.72 vs BASDAI 0.58; SP 0.52 vs SF-36 social functioning 0.29; PF 0.32 vs BASFI 0.28 and SF-36 PF 0.24; EWB 0.40 vs HADS-anxiety 0.13, HADS-depression 0.21 and SF-36 mental health 0.35. ES for the ASQoL was 0.40. Superior ES was seen in those improving somewhat. In the randomized trial, all EASi-QoL domains had superior responsiveness to comparator measures following ETN treatment. Following SSZ treatment, all EASi-QoL domains were highly responsive, but BASDAI and BASFI was more responsive than EASi-QoL(DA) and (PF), respectively.Conclusion. In patients reporting improvement during routine clinical practice or following treatment with ETN or SSZ, EASi-QoL domains have superior or comparable responsiveness than comparable measures. [ABSTRACT FROM PUBLISHER]

Background. There is little evidence for the measurement properties of instruments commonly used for women with pelvic girdle pain. Objective. The aim of this study was to examine the internal consistency, test-retest reliability, and construct validity of instruments used for women with pelvic girdle pain. Design. This was a cross-sectional methodology study, including test-retest reliability assessment. Methods. Women with pelvic girdle pain in pregnancy and after delivery participated in a postal survey that included the Pelvic Girdle Questionnaire (PGQ), Oswestry Disability Index (ODI), Disability Rating Index (DRI), Fear-Avoidance Beliefs Questionnaire (FABQ), Pain Catastrophizing Scale (PCS), and 8-item version of the Medical Outcomes Study 36-Item Short-Form Health Survey questionnaire (SF-36). Test-retest reliability was assessed with a random subsample 1 week later. Internal consistency was assessed with the Cronbach alpha, and test-retest reliability was assessed with the intraclass correlation coefficient (ICC) and minimal detectable change (MDC). Construct validity based on hypotheses was assessed by correlation analysis. Discriminant validity was assessed with the area under the receiver operating characteristic curve. Results. All participants responded to the main (N=87) and test-retest (n=42) surveys. Cronbach alpha values ranged from .88 to .94, and ICCs ranged from .78 to .94. The MDC at the individual level constituted about 7% to 14% of total scores for the 8-item version of the SF-36, ODI, and PGQ activity subscale; about 18% to 22% for the DRI, PGQ symptom subscale, and PCS; and about 25% for the FABQ. Hypotheses were mostly confirmed by correlations between the instruments. The PGQ was the only instrument that significantly discriminated participants who were pregnant from participants who were not pregnant as well as pain locations. Limitations. A comparison of responsiveness to change of the various instruments used in this study was not undertaken, but will be carried out in a future study. Conclusions. Self-report instruments for assessing health showed good internal consistency, test-retest reliability, and construct validity for women with pelvic girdle pain. The PGQ was the only instrument with satisfactory discriminant validity, thus, it is recommended for evaluating symptoms and disability in patients with pelvic girdle pain. [ABSTRACT FROM AUTHOR]

Background: There is variation in the number of response alternatives used within health-related questionnaires. This study compared a four-and a five-point scale version of the Norwegian Function Assessment Scale (NFAS) by evaluating data quality, internal consistency and validity. Methods: All inhabitants in seven birth cohorts in the Ullensaker municipality of Norway were approached by means of a postal questionnaire. The NFAS was included as part of The Ullensaker Study 2004. The instrument comprises 39 items derived from the activities/participation component in the International Classification for Functioning, Disabilities and Health (ICF). The sample was computer-randomised to either the four-point or the five-point scale version. Results: Both versions of the NFAS had acceptable response rates and good data quality and internal consistency. The five-point scale version had better data quality in terms of missing data, end effects at the item and scale level, as well as higher levels of internal consistency. Construct validity was acceptable for both versions, demonstrated by correlations with instruments assessing similar aspects of health and comparisons with groups of individuals known to differ in their functioning according to existing evidence. Conclusion: Data quality, internal consistency and discriminative validity suggest that the five-point scale version should be used in future applications. [ABSTRACT FROM AUTHOR]

Aims: This article describes the development of a questionnaire designed for comparisons of patient experiences of hospital care within the Nordic countries. The results of testing for data quality, reliability, and validity are presented following a Norwegian survey. Methods: Following a literature review and consultation within an expert group six items were developed measuring patient experiences together with two items assessing global satisfaction and perception of incorrect treatment. The questions were included in a questionnaire that was mailed to 500 patients randomly selected from patients receiving inpatient treatment at a large university hospital in Norway. Principal component analysis was used to assess dimensionality. Reliability was assessed by the internal consistency and test-retest methods. Construct validity was assessed by the scale's correlation with variables known to be related to patient experiences. Results: A total of 244 (48.8%) patients responded. Levels of missing data ranged from 0.4% to 2.5%. The six items in the questionnaire that measured important aspects of patient experiences with the services contributed to a single scale with item-total correlations in the range 0.59-0.71 and a Cronbach's alpha of 0.85. The test-retest intraclass correlation was 0.88. Conclusions: The NORPEQ is a brief measure of patient experiences that covers important aspects of the healthcare encounter. It shows good evidence of reliability and validity and is relatively easy to apply alongside existing national surveys. [ABSTRACT FROM AUTHOR]

Background: The SF-36 Health Survey questionnaire has been proposed as a generic measure of health outcome. However, poor rates of return and high levels of missing data have been found in elderly subjects and, even with face-to-face interview, reliability and validity may still be disappointing, particularly in cognitively impaired patients. These patients may be the very patients whose quality of life is most affected by their illness and their exclusion will lead to biased evaluation of health status. A possible alternative to total exclusion is the use of a proxy to answer on the patient’s behalf, but few studies of older people have systematically studied patient-proxy agreement. Objective: To compare the agreement between patients, lay and professional proxies when assessing the health status of patients with the SF-36. Methods: The SF-36 was administered by interview to 164 cognitively normal, elderly patients (Mini-mental State Examination 24 or more) referred for physical rehabilitation. The SF-36 was also completed by a patient-designated lay proxy (by post) and a professional proxy. Agreement between proxies and patients was measured by intraclass correlation coefficients (ICCs), and a bias index. Results: Professional proxies were better able to predict the patients’ responses than were the lay proxies. Criterion levels of agreement (ICC 0.4 or over) were attained for four of the eight dimensions of the SF-36 by professional proxies, but for only one dimension by lay proxies. In professional proxies, the magnitude of the bias was absent or slight (<0.2) for six of the eight dimensions of the SF-36 with a small (0.2–0.49) negative bias for the other two. Lay proxies showed a negative bias (i.e. they reported poorer function than did the patients themselves) for seven of the eight dimensions of the SF-36 (small in two and moderate (0.5–0.79) in five). Conclusions: For group comparisons using the SF-36, professional proxies might be considered when patients cannot answer reliably for themselves. However, in the present study, lay proxy performance on a postal questionnaire showed a strong tendency to negative bias. Further research is required to define the limitations and potentials of proxy completion of health status questionnaires.Copyright © 2001 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

AbstractReliability and validity of the SF-36 Health Survey Questionnaire was assessed in older rehabilitation patients, comparing cognitively impaired with cognitively normal subjects. The SF-36 was administered by face-to-face interview to 314 patients (58–93 years) in the day hospital and rehabilitation wards of a department of medicine for the elderly. Reliability was measured using Cronbach’s alpha (for internal consistency) on the main sample and intraclass correlation coefficients on a test–retest sample; correlations with functional independence measure (FIM) were examined to assess validity. In 203 cognitively normal patients (Mini-Mental State Examination ≥24), Cronbach’s alpha scores on the eight dimensions of the SF-36 ranged from 0.545 (social function) to 0.933 (bodily pain). The range for the 111 cognitively impaired patients was 0.413–0.861. Cronbach’s alpha values were significantly higher (i.e. reliability was better) in the cognitively normal group for bodily pain (P = 0.003), mental health (P = 0.03) and role emotional (P = 0.04). In test–retest studies on a further 67 patients, an intraclass correlation coefficient of 0.7 was attained for five out of eight dimensions in cognitively normal patients, and four out of eight dimensions in the cognitively impaired. Only the physical function dimension in the cognitively normal group attained the criterion level (r > 0.4) for construct validity when correlated with the FIM. In this group of older physically disabled patients, levels of reliability and validity previously reported for the SF-36 in younger subjects were not attained, even on face-to-face testing. Patients with coexistent cognitive impairment performed worse than those who were cognitively normal. [ABSTRACT FROM AUTHOR]

The assessment of quality of life is becoming increasingly important in clinical research. Its importance in dentistry has been realised only relatively recently. Health-related quality of life is concerned with the aspects of quality of life that relate specifically to an individual's health. This may be measured using two groups of instruments: (i) generic measures, which provide a summary of health-related quality of life and sometimes generate a single index measure of health or (ii) condition-specific measures, which focus on a particular condition, disease, population or problem and are potentially more responsive to small, but clinically important, changes in health. Objectives: The aim of this study was to develop a condition-specific quality of life measure for those patients with severe dentofacial deformity who were requesting orthognathic treatment and to assess the reliability of this instrument. Method: Instrument content was derived through a literature review and interviews with clinicians and patients. The resulting instrument was tested for internal consistency and test-retest reliability. Results and conclusions: The instrument was found to divide into four clinically meaningful domains. Internal consistency and test-retest reliability were good. Patient acceptance of the questionnaire was also encouraging. [ABSTRACT FROM AUTHOR]