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Background: The Respiratory Infection Intensity and Impact Questionnaire (RiiQ™) is a patient-reported outcome measure designed to assess symptoms and impacts of respiratory syncytial virus (RSV) infection. This study evaluated the construct validity, reliability, and responsiveness of the RiiQ™ Respiratory and Systemic Symptoms Scale scores. Methods: Prospective data were analyzed from a total of 1795 participants, including from non-hospitalized patients with acute respiratory infection (ARI) and no coinfections enrolled in a Phase 2b RSV vaccine study (RSV-positive: n = 60; RSV-negative: n = 1615), and two observational studies of patients hospitalized with RSV (n = 20; n = 100). Descriptive statistics, confirmatory factor analysis (CFA), test–retest intraclass correlation coefficients (ICCs), construct validity correlations (between a clinician-assessed clinical questionnaire and the RiiQ™ symptoms scale), known-groups validity, and responsiveness (correlations of change scores) were evaluated. Results: Mean patient age ranged from 66.5 to 71.5 years and the majority of patients were female. Initial assessments in the vaccine trial (ARI Day 1) were suggestive of less severe illness than in the observational studies with hospitalized patients. CFA loadings (> 0.40) supported summary scores. ICCs exceeding the recommended threshold of 0.70 supported test–retest reliability for Respiratory and Systemic Symptoms, except in the small observational study. At the scale level, correlations were moderate to strong (|r| ≥ 0.3) and positive between the Respiratory Symptoms Scale and the related clinical questionnaire scores, reflecting measurement of similar symptoms in support of convergent validity. Correlations with change in Patient Global Impression of Severity > 0.30 supported responsiveness. Conclusions: Psychometric tests applied to the RiiQ™ Symptoms scales provide evidence of its reliability, construct validity, discriminating ability, and responsiveness for use in clinical studies to assess the onset and severity of RSV symptoms. [ABSTRACT FROM AUTHOR]

Aim: Health literacy is a potential factor contributing to health disparities in migrant groups. This exploratory work sought to investigate the validity of the health literacy questionnaire (HLQ) in exploring the health literacy needs of migrant people in a vulnerable borough of Montpellier, France. Subjects and methods: The multidimensional HLQ was administered, together with cognitive interviews, to 17 persons with varying French language skills benefiting from a community health education program. Results: The great majority of HLQ items were understood as intended in this sample, with markedly heterogenous health literacy profiles. Participants with the lowest education found some words or concepts difficult to understand, but the endorsed response options were consistent with their narrative during qualitative interviews. Conclusion: This study adds to the growing body of evidence ensuring the cross-cultural validity of the HLQ lying on culturally generic translated item concepts. This is of importance for the exploration of both health literacy strengths and weaknesses, which provides critical insights into potentially relevant responsiveness to the needs of vulnerable persons experiencing the complex challenges of migration. [ABSTRACT FROM AUTHOR]

Background: Contrary to common usage in the health sciences, the term "valid" refers not to the properties of a measurement instrument but to the extent to which data-derived inferences are appropriate, meaningful, and useful for intended decision making. The aim of this study was to determine how validity testing theory (the Standards for Educational and Psychological Testing) and methodology (Kane's argument-based approach to validation) from education and psychology can be applied to validation practices for patient-reported outcomes that are measured by instruments that assess theoretical constructs in health. Methods: The Health Literacy Questionnaire (HLQ) was used as an example of a theory-based self-report assessment for the purposes of this study. Kane's five inferences (scoring, generalisation, extrapolation, theory-based interpretation, and implications) for theoretical constructs were applied to the general interpretive argument for the HLQ. Existing validity evidence for the HLQ was identified and collated (as per the Standards recommendation) through a literature review and mapped to the five inferences. Evaluation of the evidence was not within the scope of this study. Results: The general HLQ interpretive argument was built to demonstrate Kane's five inferences (and associated warrants and assumptions) for theoretical constructs, and which connect raw data to the intended interpretation and use of the data. The literature review identified 11 HLQ articles from which 57 sources of validity evidence were extracted and mapped to the general interpretive argument. Conclusions: Kane's five inferences and associated warrants and assumptions were demonstrated in relation to the HLQ. However, the process developed in this study is likely to be suitable for validation planning for other measurement instruments. Systematic and transparent validation planning and the generation (or, as in this study, collation) of relevant validity evidence supports developers and users of PRO instruments to determine the extent to which inferences about data are appropriate, meaningful and useful (i.e., valid) for intended decisions about the health and care of individuals, groups and populations. [ABSTRACT FROM AUTHOR]

Purpose: To empirically define the concept of burden of neck pain. The lack of a clear understanding of this construct from the perspective of persons with neck pain and care providers hampers adequate measurement of this burden. An additional aim was to compare the conceptual model obtained with the frequently used Neck Disability Index (NDI).Methods: Concept mapping, combining qualitative (nominal group technique and group consensus) and quantitative research methods (cluster analysis and multidimensional scaling), was applied to groups of persons with neck pain (n = 3) and professionals treating persons with neck pain (n = 2). Group members generated statements, which were organized into concept maps. Group members achieved consensus about the number and description of domains and the researchers then generated an overall mind map covering the full breadth of the burden of neck pain.Results: Concept mapping revealed 12 domains of burden of neck pain: impaired mobility neck, neck pain, fatigue/concentration, physical complaints, psychological aspects/consequences, activities of daily living, social participation, financial consequences, difficult to treat/difficult to diagnose, difference of opinion with care providers, incomprehension by social environment, and how person with neck pain deal with complaints. All ten items of the NDI could be linked to the mind map, but the NDI measures only part of the burden of neck pain.Conclusion: This study revealed the relevant domains for the burden of neck pain from the viewpoints of persons with neck pain and their care providers. These results can guide the identification of existing measurements instruments for each domain or the development of new ones to measure the burden of neck pain. [ABSTRACT FROM AUTHOR]

Background: Data from subjective patient-reported outcome measures (PROMs) are now being used in the health sector to make or support decisions about individuals, groups and populations. Contemporary validity theorists define validity not as a statistical property of the test but as the extent to which empirical evidence supports the interpretation of test scores for an intended use. However, validity testing theory and methodology are rarely evident in the PROM validation literature. Application of this theory and methodology would provide structure for comprehensive validation planning to support improved PROM development and sound arguments for the validity of PROM score interpretation and use in each new context.Objective: This paper proposes the application of contemporary validity theory and methodology to PROM validity testing.Illustrative Example: The validity testing principles will be applied to a hypothetical case study with a focus on the interpretation and use of scores from a translated PROM that measures health literacy (the Health Literacy Questionnaire or HLQ).Discussion: Although robust psychometric properties of a PROM are a pre-condition to its use, a PROM's validity lies in the sound argument that a network of empirical evidence supports the intended interpretation and use of PROM scores for decision making in a particular context. The health sector is yet to apply contemporary theory and methodology to PROM development and validation. The theoretical and methodological processes in this paper are offered as an advancement of the theory and practice of PROM validity testing in the health sector. [ABSTRACT FROM AUTHOR]

Background: The SF36 Version 2 (SF36V2) is a revision of the SF36 Version 1, and is a widely used health status measure. It is important that guidelines for interpreting scores are available.Method: A population sample of Australians (n = 3015) weighted to achieve representativeness was administered the SF36V2. Comparisons between published US weights and sample derived weights were made, and Australian population norms computed and presented.Major Findings: Significant differences were observed on 7/8 scales and on the mental health summary scale. Possible causes of these findings may include different sampling and data collection procedures, demographic characteristics, differences in data collection time (1998 vs. 2004), differences in health status or differences in cultural perception of the meaning of health. Australian population norms by age cohort, gender and health status are reported by T-score as recommended by the instrument developers. Additionally, the proportions of cases within T-score deciles are presented and show there are important data distribution issues.Principal Conclusions: The procedures reported here may be used by other researchers where local effects are suspected. The population norms presented may be of interest. There are statistical artefacts associated with T-scores that have implications for how SF36V2 data are analysed and interpreted. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the reliability, agreement and smallest detectable change in a measurement instrument for pain and function in knee osteoarthritis; the Dynamic weight-bearing Assessment of Pain (DAP).Methods: The sample size was set to 20 persons, recruited from the outpatient osteoarthritis clinic at Frederiksberg Hospital, Copenhagen. Two physiotherapists tested all participants during two visits; at the first visit, one single DAP (including four scores) was conducted by rater one; at the second visit, DAP was conducted by both raters one and two in randomized order with concealed allocation. The time interval was approximately 1.5 h. Measurement error was estimated by standard error of measurement (SEM). The intra- and inter-rater reliability was estimated by Intra-class Correlation Coefficients for agreement based on a two-way ANOVA with random effects (single measures ICC 2.1). Smallest detectable change (SDC) and limits of agreement were calculated.Results: The pain score showed excellent reliability in terms of ICC (intra-rater 0.93, CI 0.83-0.97, inter-rater 0.91, CI 0.78-0.96), low SEM (intra-rater 0.70, inter-rater 0.86, on a scale from 0 to 10), and acceptable SDC for intra-rater test (1.95). The three knee bend scores all had ICC above 0.50, showing fair-to-good reliability. None of the knee bend scores showed acceptable SEM and SDC.Conclusions: The reproducibility of the DAP pain score meets the demands for use in clinical practice and research. The total knee bend could be useful for motivational purpose in clinical use. Testing of other psychometric properties of the DAP is pending. [ABSTRACT FROM AUTHOR]

Objective: To comprehensively identify components of the physical limitation concept in knee osteoarthritis (OA) and to rate the clinical importance of these using perspectives of both patients and health professionals. Design: Concept mapping, a structured group process, was used to identify and organize data in focus groups (patients) and via a global web-based survey (professionals). Ideas were elicited through a nominal group technique and then organized using multidimensional scaling, cluster analysis, participant validation, rating of clinical importance, and thematic analyses to generate a conceptual model of physical limitations in knee OA. Results: Fifteen Danish patients and 200 international professionals contributed to generating the conceptual model. Five clusters emerged: 'Limitations/physical deficits'; 'Everyday hurdles'; 'You're not the person you used to be'; 'Need to adjust way of living'; and 'External limitations,' each with sub-clusters. Patients generally found their limitations more important than the professionals did. Conclusion: Patients and professionals agreed largely on the physical limitation concept in knee OA. Some limitations of high importance to patients were lower rated by the professionals, highlighting the importance of including patients when conceptualizing patient outcomes. These data offer new knowledge to guide selection of clinically relevant outcomes and development of outcome measures in knee OA. [ABSTRACT FROM AUTHOR]

Purpose: If measurement invariance (MI) is demonstrated for a scale completed by respondents from two different language groups, it means that the scale measures the same construct in the same way in both groups. We assessed MI of the French- and English-language versions of the five Health Education Impact Questionnaire (heiQ) empowerment scales validated for the cancer setting. Methods: Data came from two cross-sectional studies of Canadian cancer survivors (704 English, 520 French). Single-group confirmatory factor analysis (CFA) was used to test whether the hypothesized factor structure of the French-language heiQ empowerment scales fit the data. Multi-group CFAs were conducted to assess different levels of MI conditions (configural, metric, scalar, strict, as well as MI of factor variances, covariances, and latent means) of the French- and English-language heiQ empowerment scales. Results: The correlated five-factor model showed good fit in both language groups (goodness-of-fit indices: CFI ≥ .97; RMSEA ≤ .07). Goodness-of-fit indices and tests of differences in fit between models supported MI of the five-factor model across the two language groups (∆CFI ≤ −.010 combined with ∆RMSEA ≤ .015). Conclusions: The French- and English-language heiQ empowerment scales measure the same five dimensions of empowerment in the same way across both language groups. Thus, any observed similarities or differences between French- and English-speaking respondents completing these scales are valid and reflect similarities or differences in empowerment across language groups, not measurement artifact. Consequently, heiQ empowerment data from English- and French-speaking respondents can be directly pooled or contrasted in data analyses. [ABSTRACT FROM AUTHOR]

Purpose: To carry out a systematic review of program outcomes used in the evaluation of group-based self-management interventions aimed at people with arthritis and other chronic conditions. Methods: The systematic search was performed across databases MEDLINE, EMBASE, CINAHL, and PsycINFO. Both between-group and within-group effect sizes (ES) were calculated. Results were interpreted as small (ES ~ 0.2), medium (ES ~ 0.5), or large (ES ~ 0.8) effects. Results: The majority of 18 included trials investigated the effectiveness of arthritis-specific interventions. Across most outcomes, small effects on course participants were shown. While effects on knowledge were large (between-group ES = 0.78), effects on clinical outcomes such as pain (ES = 0.10) were negligible to small. Conclusions: This paper is consistent with other reviews in this area, suggesting that people with arthritis receive only marginal benefits from participating in chronic disease self-management interventions. When looking at the types of outcomes that trials are based on, however, alternative explanations for these results seem probable. As evaluations heavily rely on patient self-report, current approaches to program evaluation may not be sufficient to assess the intended impact of self-management education. An in-depth investigation of the types of outcomes assessed is provided in a separate paper. [ABSTRACT FROM AUTHOR]

Objectives: To provide an in-depth analysis of outcome measures used in the evaluation of chronic disease self-management programs consistent with the Stanford curricula. Methods: Based on a systematic review on self-management programs, effect sizes derived from reported outcome measures are categorized according to the quality of life appraisal model developed by Schwartz and Rapkin which classifies outcomes from performance-based measures (e.g., clinical outcomes) to evaluation-based measures (e.g., emotional well-being). Results: The majority of outcomes assessed in self-management trials are based on evaluation-based methods. Overall, effects on knowledge-the only performance-based measure observed in selected trials-are generally medium to large. In contrast, substantially more inconsistent results are found for both perception- and evaluation-based measures that mostly range between nil and small positive effects. Conclusions: Effectiveness of self-management interventions and resulting recommendations for health policy makers are most frequently derived from highly variable evaluation-based measures, that is, types of outcomes that potentially carry a substantial amount of measurement error and/or bias such as response shift. Therefore, decisions regarding the value and efficacy of chronic disease self-management programs need to be interpreted with care. More research, especially qualitative studies, is needed to unravel cognitive processes and the role of response shift bias in the measurement of change. [ABSTRACT FROM AUTHOR]

Background: Health literacy is the capacity to seek, understand and utilise health information to make informed health decisions. Suboptimal health literacy has been linked to poor health outcomes. This study assessed health literacy in patients treated for head and neck or lung cancer and associations between health literacy and demographic factors and distress levels. Methods: Consecutive English-speaking patients were approached at Peter MacCallum Cancer Centre. Face-to-face interviews were conducted. Health literacy was assessed using the Shortened Test of Functional Health Literacy in Adults (S-TOFHLA) and Health Literacy Management Scale (HeLMS). Distress was assessed by the Distress Thermometer. Results: Response rate was 73 % ( n = 93). Using S-TOFHLA, prevalence of inadequate and marginal health literacy was 5.4 and 6.5 % respectively, and both groups were associated with older age ( p = 0.043) and low education level ( p = 0.009). Specific assessment of S-TOFHLA revealed that 70 % could not interpret prescription labels. HeLMS reported that 17 % had health literacy difficulties. Low scores on domains of HeLMS were associated with lower education level ( p < 0.05) but younger age ( p < 0.05). Distress was not associated with S-TOFHLA scores but related to low scores in two domains of HeLMS ( p < 0.05). Conclusion: Using two different measures, a substantial proportion of patients have poor health literacy abilities and may experience difficulties in accessing health services. [ABSTRACT FROM AUTHOR]

Purpose: This paper describes the translation, cultural adaption, and psychometric evaluation of a German version of the Health Education Impact Questionnaire (heiQ™), a widely used generic instrument assessing a wide range of proximal outcomes of self-management programs.Methods: The translation was carried out according to international standards and included forward and backward translations. Comprehensibility and content validity were tested using cognitive interviews with 10 rehabilitation inpatients. Psychometric properties were examined in rehabilitation inpatients (n = 1,202) with a range of chronic conditions. Factorial validity was assessed using confirmatory factor analysis; concurrent validity was explored by correlations with comparator scales.Results: The items of the German heiQ™ were well understood by rehabilitation inpatients. The structure of the eight heiQ™ scales was replicated after minor adjustment. heiQ™ scales had higher correlations with comparator scales with similar constructs, particularly mental health concepts than with physical health. Moreover, all heiQ™ scales differentiated between individuals across different levels of depression.Conclusion: The German heiQ™ is comprehensible for German-speaking patients suffering from different types of chronic conditions; it assesses relevant outcomes of self-management programs in a reliable and valid manner. Further studies involving its practical application are warranted. [ABSTRACT FROM AUTHOR]

Objectives: Program evaluations are frequently based on 'then-test' data, i.e., pre-test collected in retrospect. While the application of the then-test has practical advantages, little is known about the validity of then-test data. Because of the collection of then-test in close proximity to post-test questions, this study was aimed at exploring whether the presence of then-test questions in post-test questionnaires influenced subjects' responses to post-test. Patients and methods: To test the influence of then-test questions, we designed a randomized three-group study in the context of chronic disease self-management programs. Interventions had comparable goals and philosophies, and all 949 study participants filled out identical Health Education Impact Questionnaires (heiQ) at pre-test. At post-test, participants were then randomized to one of the following three groups: Group A responded to post-test questions only ( n = 331); Group B filled out transition questions in addition to post-test ( n = 304); and Group C filled out then-test questions in addition to post-test ( n = 314). Results: Significant post-test differences were found in six of eight heiQ scales, with respondents who filled out then-test questions reporting significantly higher post-test scores than respondents of the other groups. Conclusions: This study provides evidence that the inclusion of then-test questions alters post-test responses, suggesting that change scores based on then-test data be interpreted with care. [ABSTRACT FROM AUTHOR]

The C282Y and H63D mutations in the HFE gene are important causes of hemochromatosis. In the elderly, these mutations might be associated with increased morbidity because of the lifelong accumulation of iron. In a population-based sample of the elderly, we determined the value of genotyping for HFE mutations to screen for subclinical hemochromatosis. HFE genotype frequencies were determined in a random group of 2095 subjects (55 years and over). In this random group, we selected within the six genotype groups a total of 342 individuals and measured their serum transferrin saturation, iron and ferritin levels. We also estimated the heritability and parameters needed to evaluate screening, including the sensitivity, specificity, positive and negative predictive values (PPV, NPV) of HFE genotypes. Iron parameters were significantly increased in subjects homozygous, heterozygous or compound heterozygous. The effect of the mutations was more pronounced in men than in women. For the H63D mutation, an allele dose effect was observed. The HFE gene explained about 5% of the variability in serum iron indices. The PPV for hemochromatosis for the C282Y homozygous was 100% in men and 67% in women. The NPV of the wild-type allele was 97% for both men and women. The sensitivity of both mutations was 70% for men and 52% for women and the specificity was 62% for men and 64% for women. Our study shows that the HFE C282Y and H63D are determinants of iron parameters in the elderly and will be effective in detecting individuals at high risk of hemochromatosis. However, when screening based on these two mutations, some individuals with subclinical hemochromatosis will be missed. [ABSTRACT FROM AUTHOR]

The goal of this work was to investigate preference techniques to value potential health gains from treatments of Kaposi sarcoma (KS). The study was designed to take the form of face-to-face interviews with a sample of men with a history of HIV/AIDS ( n=15) or HIV/AIDS and KS ( n=17). The main outcome measure was quality of life (QoL) associated with various KS disease states expressed on a scale from 0 (death) to 1 (perfect health), obtained though time trade-off (TTO) and rating scale techniques. For cutaneous lesions only, the mean TTO preference score value was 0.27. In other words, the men were willing to trade a life expectancy of 5 years for a shorter period (1.4 years) in perfect health. More severe KS health states were rated lower (0.07–0.09). The mean rating scale value for cutaneous lesions only was 0.11 and ranged from –0.10 to –0.04 for the more severe conditions; these values were systematically lower than the TTO ( P=0.014). A large overall potential gain in QoL from treatment (partial response minus stable disease) was found for each condition to be reflected in both the TTO (from 0.31 to 0.55) and the rating scale (from 0.38 to 0.44). Respondents associate KS health states with extremely poor QoL and indicate that large gains are possible through modest treatment effects. While TTO returns higher values than the rating scale, potential gains from treatments were similar. The techniques appear to be suitable for application to QoL and economic evaluation of treatments of KS. [ABSTRACT FROM AUTHOR]

This paper describes constructing the Assessment of Quality of Life (AQoL) instrument; designed to measure health-related quality of life (HRQoL), and to be the descriptive system for a multi-attribute utility instrument. Unlike previous utility instruments' descriptive systems, the AQoL's has been developed using state-of-the-art psychometric procedures. The result is a descriptive system which emphasizes five different facets of HRQoL and which can claim to have construct validity. Based on the WHO's definition of health a model of HRQoL was developed. Items were written by focus groups of doctors and the researchers. These were administered to a construction sample, comprising hospital patients, and community members chosen at random. Final construction was through an iterative process of factor and reliability analyses. The AQoL measures 5 dimensions: illness, independent living, social relationships, physical senses and psychological wellbeing. Each has three items. Exploratory factor analysis showed the dimensions were orthogonal, and each was unidimensional. Internal consistency was alpha = 0.81. Structural equation modeling explored its internal structure; the comparative fit index was 0.90. These preliminary results indicate the AQoL has the prerequisite qualities for a psychometric HRQoL instrument for evaluation; replication with a larger sample is needed to verify these findings. Scaling it for economic evaluation using utilities is being undertaken. Respondents have indicated the AQoL is easy to understand and is quickly completed. Its initial properties suggest it may be widely applicable. [ABSTRACT FROM AUTHOR]

Twenty patients with previously untreated ovarian cancer received intensive chemotherapy after initial surgery. Treatment comprised two courses of cyclophosphamide at 7 g/m2 with mesna, re-evaluation with second-look laparotomy where appropriate, followed by five courses of cisplatin at 100 mg/m2. Three patients achieved pathologically documented complete remission (PDCR) with high-dose cyclophosphamide, and eight patients achieved partial remission. Fifteen patients went on to receive cisplatin. Nine of these patients had no assessable disease; of six patients who were assessed for response two achieved PDCR and three achieved partial remission. The overall response rate to the sequential regimen was 14/20 (70%). High-dose cyclophosphamide was associated with marked haematological toxicity, which was cumulative and fatal in two patients. The median duration of first remission was 14 months, and the median duration of survival was 20 months. It is concluded that sequential treatment with high-dose cyclophosphamide and cisplatin appears to be no more effective than conventional treatment in advanced ovarian cancer, judging by the PDCR rate and median survival achieved. [ABSTRACT FROM AUTHOR]

We have extended our work on structure/activity relationship studies of the neuropeptiden proctolin (H-Arg-Tyr-Leu-Pro-Thr-OH) by evaluating the effects of the following proctolin analogues: H-X-Tyr-Leu-Pro-Thr-OH, where X = D-Arg (I), N-Me-Arg (II), Can (III), Orn(di-Me) (IV), Orn(iPr) (V), Lys(N, N-di-Me) (VI), Lys(iPr) (VII), Lys(Nic) (VIII) and D-Lys(Nic) (IX). In analogues I-IX, the N-terminal Arg residue was replaced by basic amino acid derivatives with peptides containing amino acid residues with an isosteric system on the back side chain relative to Arg (compounds III, V and VI) or homo-Arg (compound VII). Analogues I-IX were evaluated for myotropic activity on the in vitro heart preparation of Tenebrio molitor, whereas peptides II, V, and VII-IX were tested for contractile activity on the isolated foregut of locust Schistocerca gregaria. Peptide II and III showed full cardiotropic activity in T. molitor while peptides V and VII showed 40% and 15%, respectively, locust-gut contracting activity of proctolin. [ABSTRACT FROM AUTHOR]

The effect of dose on the bioavailability of oral etoposide was investigated in ten patients with malignant mesothelioma who received single-agent etoposide as part of a phase II study. Etoposide pharmacokinetics were studied in each patient at oral dose levels of 100, 200, 300, 400 and 600 mg. At doses above 200 mg, the AUC and peak concentrations of etoposide were substantially lower than predictions based on the 100-mg dose. This study confirms previous observations that etoposide absorption is dose-dependent and that a mean bioavailability of approximately 50% cannot be assumed at total oral doses greater than 200 mg. [ABSTRACT FROM AUTHOR]

The article discusses the role of self-management support and programs for people with arthritis and other chronic diseases. It states that self-management support is the facility that health care and social-care services offer to make individuals take better care of themselves. It mentions that for arthritis, the prevailing approach to self-management support has been the implementation of community-based group programs.