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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]

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]

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: Research studies may have limited generalizability when survivors of stroke with physical, language, or cognitive impairments are excluded. Aims: To assess whether presence of cognitive, language, or global impairments affects participation in self-management programs. Methods: Stroke survivors were recruited in South Australia from seven hospitals or via advertisements into a randomized controlled trial (1:1:1 ratio) of a Stroke Self-Management Program, the Stanford chronic condition self-management program, or standard care. Impairment status was measured using: Cognistat (cognition), Frenchay Aphasia assessment (language), modified Rankin Score (mRS; where score 3-5 = global disability). Primary outcomes: participation (i.e. booked, accessed, and completed a program (defined as attending ≥ 50% of sessions)) and safety (i.e. adverse events). Outcomes were compared by impairment status. Results: Among 315 people screened 143/149 eligible were randomized (median age 71 years; 41% male; with impairments: 62% cognitive, 34% language, 64% global disability). Participation did not differ by cognitive or language impairment status (cognitive 75%, no cognitive 68%, p = 0.54; language 78%, no language 69%, p = 0.42). However, participation did vary by global impairment status (global disability 61%, no disability 96%, p < 0.001). Participants with cognitive impairment experienced more adverse events (severe n = 9 versus no cognitive impairment n = 1). Conclusion: Survivors of stroke with cognitive, language, or global impairments are able to participate in self-management programs and should be included in these types of research studies or programs. Reduced participation by those with global disability and the possibility of more adverse events in people with cognitive impairments needs to be considered. [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]

BACKGROUND Empowerment refers to an individual's feelings of being able to manage the challenges of the cancer experience and of having a sense of control over one's life. However, empowerment questionnaires that have been validated for the cancer setting are lacking. The objective of this study was to validate scales from the Health Education Impact Questionnaire (heiQ), which assesses the effects of health education programs among individuals with chronic conditions. The heiQ scales Social integration and support, Health service navigation, Constructive attitudes and approaches, Skill and technique acquisition, and Emotional distress were identified as key dimensions of empowerment for the cancer context. METHODS Adults who were diagnosed with cancer <3 years earlier were recruited from a population-based cancer registry and from the Canadian Cancer Society's information and peer-support programs. The 731 participants completed a mailed questionnaire, which included the heiQ scales, related constructs, and demographics. Reliability was assessed using Cronbach α values, and validity was determined using confirmatory factor analysis and scale correlations with related constructs (self-efficacy, intrusive thoughts about cancer, and mental and physical health). RESULTS The hypothesized 5-factor model fit the data adequately (chi-square statistic, 528.17; degrees of freedom, 265; root mean square error of approximation, .04; non-normed fit index, .99; comparative fit index, 1.00; standardized root mean residual, .05). Factor loadings were high (23 of 25 were ≥.70), and the factor correlations indicated separate but related constructs. Cronbach α values ranged from .75 to .90. A priori hypotheses about the correlations between heiQ scales and related constructs all were supported. CONCLUSIONS The current results support the validity of these 5 heiQ scales as generic measures of health-related empowerment in the cancer setting. These scales could fill an important gap in the measures currently available to evaluate proximal effects of support interventions. Cancer 2014;120:3228-3236. © 2014 American Cancer Society. [ABSTRACT FROM AUTHOR]

Background Patient-reported outcomes (PROs) are particularly relevant in influenza vaccine trials in the elderly where reduction in symptom severity could prevent illness-related functional impairment. Objectives To evaluate PROs in people aged ≥65 years receiving two different vaccines. Methods This was a phase III, randomised, observer-blind study (NCT00753272) of the AS03-adjuvanted inactivated trivalent split-virion influenza vaccine (AS03-TIV) versus non-adjuvanted vaccine (TIV). Using the FluiiQ questionnaire, symptom (systemic, respiratory, total) and life impact (activities, emotions, relationships) scores were computed as exploratory endpoints, with minimal important difference (MID) in influenza severity between vaccines considered post-hoc as >7%. Vaccine efficacy of AS03-TIV relative to TIV in severe influenza (hospitalisation, complication, most severe one-third of episodes based on the area under the curve for systemic symptom score) was calculated post-hoc. The main analyses (descriptive) were conducted in the according-to-protocol cohort ( n = 280 AS03-TIV, n = 315 TIV) for influenza confirmed by culture or reverse transcriptase polymerase chain reaction. Results Mean systemic symptom, total symptom and impact on activities scores were lower with AS03-TIV versus TIV. Mean respiratory symptom, impact on emotions and impact on relationships scores were similar. Influenza tended to be less severe with AS03-TIV, but the MID was reached only for impact on activities (mean 9·0%). Relative vaccine efficacy in severe influenza was 29·38% (95% CI: 7·60-46·02). Conclusions AS03-TIV had advantages over TIV in impact on systemic symptoms and activities as measured by the FluiiQ in elderly people. Higher efficacy of AS03-TIV relative to TIV was shown for prevention of severe illness. [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]

The Orthopaedic Unit of the Repatriation General Hospital (RGH) in Adelaide, South Australia has implemented a quality care management system for patients with arthritis of the hip and knee. The system not only optimises conservative management but ensures that joint replacement surgery is undertaken in an appropriate and timely manner. This new service model addresses identified barriers to service access and provides a comprehensive, coordinated strategy for patient management. Over 4 years the model has reduced waiting times for initial outpatient assessment from 8 to 3 months and surgery from 18 to 8 months, while decreasing length of stay from 6.3 to 5.3 days for hips and 5.8 to 5.3 days for knees. The service reforms have been accompanied by positive feedback from patients and referring general practitioners in relation to the improved coordination of care and enhanced efficiency in service delivery. [ABSTRACT FROM AUTHOR]

Abstract: Objective: Clinical trials of new agents to reduce the severity and impact of influenza require accurate assessment of the effect of influenza infection. Because there are limited high-quality adult influenza Patient Reported Outcomes (PRO) measures, the aim was to develop and validate a simple but comprehensive questionnaire for epidemiological research and clinical trials. Methods: Construct and item generation was guided by the literature, concept mapping, focus groups, and interviews with individuals with laboratory-confirmed influenza and expert physicians. Items were administered to 311 people with influenza-like illness (ILI) across 25 US sites. Analyses included classic psychometrics, structural equation modeling (SEM), and Rasch analyses. Results: Concept mapping generated 149 concepts covering the influenza experience and clustered into symptoms and impact on daily activities, emotions, and others. Items were drafted using simplicity and brevity criteria. Eleven symptoms from the literature underwent review by physicians and patients, and two were removed and one added. The symptoms domain factored into systemic and respiratory symptoms, whereas the impact domains were unidimensional. All domains displayed good internal consistency (Cronbach α≥0.8) except the three-item respiratory domain (α = 0.48). A five-factor SEM indicated excellent fit where systemic, respiratory, and daily activities domains differentiated patients with ILI or confirmed influenza. All scales were responsive over time. Conclusions: Patient and clinician consultations resulted in an influenza PRO measure with high validity and good overall evidence of reliability and responsiveness. The Influenza Intensity and Impact Questionnaire (FluiiQ™) will improve the evaluation of existing and future agents designed to prevent or control influenza infection by increasing the breadth and depth of measurement in this field. [Copyright &y& Elsevier]

Background: Vertebroplasty has become a common treatment for painful osteoporotic vertebral fractures, but there is limited evidence to support its use. Methods: We performed a multicenter, randomized, double-blind, placebo-controlled trial in which participants with one or two painful osteoporotic vertebral fractures that were of less than 12 months' duration and unhealed, as confirmed by magnetic resonance imaging, were randomly assigned to undergo vertebroplasty or a sham procedure. Participants were stratified according to treatment center, sex, and duration of symptoms (<6 weeks or ≥6 weeks). Outcomes were assessed at 1 week and at 1, 3, and 6 months. The primary outcome was overall pain (on a scale of 0 to 10, with 10 being the maximum imaginable pain) at 3 months. Results: A total of 78 participants were enrolled, and 71 (35 of 38 in the vertebroplasty group and 36 of 40 in the placebo group) completed the 6-month follow-up (91%). Vertebroplasty did not result in a significant advantage in any measured outcome at any time point. There were significant reductions in overall pain in both study groups at each follow-up assessment. At 3 months, the mean (±SD) reductions in the score for pain in the vertebroplasty and control groups were 2.6±2.9 and 1.9±3.3, respectively (adjusted between-group difference, 0.6; 95% confidence interval, −0.7 to 1.8). Similar improvements were seen in both groups with respect to pain at night and at rest, physical functioning, quality of life, and perceived improvement. Seven incident vertebral fractures (three in the vertebroplasty group and four in the placebo group) occurred during the 6-month follow-up period. Conclusions: We found no beneficial effect of vertebroplasty as compared with a sham procedure in patients with painful osteoporotic vertebral fractures, at 1 week or at 1, 3, or 6 months after treatment. (Australian New Zealand Clinical Trials Registry number, ACTRN012605000079640.) N Engl J Med 2009;361:557-68. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the clinical effectiveness and implementation of a falls prevention exercise programme for preventing falls in the subacute hospital setting. Design: Randomized controlled trial, subgroup analysis. Participants: Patients of a metropolitan subacute/aged rehabilitation hospital who were recommended for a falls prevention exercise programme when enrolled in a larger randomized controlled trial of a falls prevention programme. Methods: Participants in both the control and intervention groups who were recommended for the exercise programme intervention were followed for the duration of their hospital stay to determine if falls occurred. Participants had their balance, strength and mobility assessed upon referral for the exercise programme and then again prior to discharge. Participation rates in the exercise programme were also recorded. Results: Intervention group participants in this subgroup analysis had a significantly lower incidence of falls than their control group counterparts (control: 16.0 falls/1000 participant-days, intervention: 8.2 falls/1000 participant-days, log-rank test: P=0.007). However few differences in secondary balance, strength and mobility outcomes were evident. Conclusion: This exercise programme provided in addition to usual care may assist in the prevention of falls in the subacute hospital setting. [ABSTRACT FROM AUTHOR]

Abstract Objective To assess the effectiveness of a targeted, multiple intervention falls prevention programme in reducing falls and injuries related to falls in a subacute hospital. Design Randomised controlled trial of a targeted multiple intervention programme implemented in addition to usual care compared with usual care alone. Setting Three subacute wards in a metropolitan hospital specialising in rehabilitation and care of elderly patients. Participants 626 men and women aged 38 to 99 years (average 80 years) were recruited from consecutive admissions to subacute hospital wards. Intervention Falls risk alert card with information brochure, exercise programme, education programme, and hip protectors. Main outcome measures Incidence rate of falls, injuries related to falls, and proportion of participants who experienced one or more falls during their stay in hospital. Results Participants in the intervention group (n = 310) experienced 30% fewer falls than participants in the control group (n = 316). This difference was significant (Peto log rank test P = 0.045) and was most obvious after 45 days of observation. In the intervention group there was a trend for a reduction in the proportion of participants who experienced falls (relative risk 0.78, 95% confidence interval 0.56 to 1.06) and 28% fewer falls resulted in injury (log rank test P = 0.20). Conclusions A targeted multiple intervention falls prevention programme reduces the incidence of falls in the subacute hospital setting.. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To investigate the impact of generic and diabetes-specific self-management programs offered in a real world context. Methods: A quasi-experimental design with 12-week follow-up compared Living with a Chronic Condition and Living with Diabetes. Self-report data collected included: Self-management Knowledge and Skills; Health Related Quality of Life (HRQOL); Depression; Social Isolation; Loneliness; Self-efficacy; and Health Behaviours. Results: Participants (N =458) in the two programs differed on almost all baseline measures. Both demonstrated statistically significant improvements in Self-management Knowledge and Skills, as well as reductions in depression. In addition to younger age, low HRQOL, high self-efficacy and Positive and Active Engagement in Life, were the clinical factors most likely to lead to improvements in HRQOL and self-efficacy. Changes in different characteristics predicted different outcomes. Conclusion: Both generic and disease-specific programs led to improved outcomes, despite the two programs attracting significantly different participants. Referral patterns also differed but GP referral rates were low for both. Practice implications: Positive participant outcomes can be achieved in real life clinical settings. While younger people with a positive attitude may appear to gain more, it is important to encourage people from low socio-economic status to enter these programs so that social inequalities in health are not worsened. [Copyright &y& Elsevier]