[show abstract][hide abstract] ABSTRACT: BACKGROUND: Patient-reported outcome (PRO) data are integral to patient care, policy decision making and healthcare delivery. PRO assessment in pressure ulcers is in its infancy, with few studies including PROs as study outcomes. Further, there are no pressure ulcer PRO instruments available. METHODS: We used gold-standard methods to develop and evaluate a new PRO instrument for people with pressure ulcers (the PU-QOL instrument). Firstly a conceptual framework was developed forming the basis of PU-QOL scales. Next an exhaustive item pool was used to produce a draft instrument that was pretested using mixed methods (cognitive interviews and Rasch Measurement Theory). Finally, we undertook psychometric evaluation in two parts. This first part was item reduction, using PU-QOL data from 227 patients. The second part was reliability and validity evaluation of the item-reduced version using both Traditional and Rasch methods, on PU-QOL data from 229 patients. RESULTS: The final PU-QOL contains 10 scales for measuring symptoms, physical functioning, psychological well-being and social participation specific to pressure ulcers. It is intended for administration and patients rate the amount of "bother" attributed during the past week on a 3-point response scale. Scale scores are generated by summing items, with lower scores indicating better outcome. The PU-QOL instrument was found to be acceptable, reliable (Cronbach's alpha values ranging 0.89 - 0.97) and valid (hypothesised correlations between PU-QOL and SF-12 scores (r >0.30) and PU-QOL scales and sociodemographic variables (r <0.30) were consistent with predictions). CONCLUSIONS: The PU-QOL instrument provides a standardised method for assessing PROs, reflecting the domains in a pressure ulcer-specific conceptual framework. It is intended for evaluating patient orientated differences between interventions, and in particular the impact from the perspective of patients.
Health and Quality of Life Outcomes 06/2013; 11(1):95. · 2.27 Impact Factor
[show abstract][hide abstract] ABSTRACT: OBJECTIVES: Pressure ulcers are a major health problem, affect patient psychological, physical and social functioning, and cause significant treatment burden. For comprehensive assessment of the benefits of an intervention, patient-reported evidence of the impact of an intervention on important patient outcomes should be made. We systematically reviewed the quality of life literature on chronic wounds to determine the suitability of generic and chronic wound-specific outcome measures for use in evaluating patient outcomes in pressure ulcer research. DESIGN: A systematic review of the literature. DATA SOURCES: Searches of eight electronic databases from inception until May 2012 were undertaken. REVIEW METHODS: Quality of life domains, item content and content relevance were determined for identified outcome measures. The content validity of identified measures was assessed against an empirically derived pressure ulcer-specific conceptual framework. RESULTS: Three generic and 14 chronic wound measures were identified but no pressure ulcer-specific measures. None of the existing measures cover all quality of life domains important in pressure ulcers. One condition-specific measure, the Venous Leg Ulcer Measure, matched most closely conceptually, but failed to represent three important domains and contained items not specific to pressure ulcers. CONCLUSIONS: Currently, outcomes important in pressure ulcers are inadequately covered by generic and chronic wound-specific instruments despite similar conceptual models. Highlighted is the need for clear conceptualisation of content as well as determining appropriateness when selecting outcome measures in the future.
International journal of nursing studies 03/2013; · 1.91 Impact Factor
[show abstract][hide abstract] ABSTRACT: Dementia is one of the most common and serious disorders in later life and the economic and personal cost of caring for people with dementia is immense. There is a need to be able to evaluate interventions in dementia using cost-effectiveness analyses, but the generic preference-based measures typically used to measure effectiveness do not work well in dementia. Existing dementia-specific measures can effectively measure health-related quality of life but in their current form cannot be used directly to inform cost-effectiveness analysis using quality-adjusted life-years as the measure of effectiveness.
The aim was to develop two brief health-state classifications, one from DEMQOL and one from DEMQOL-Proxy, to generate health states amenable to valuation. These classification systems consisted of items taken from DEMQOL and DEMQOL-Proxy so they can be derived from any study that has used these instruments.
In the first stage of the study we used a large, clinically representative sample aggregated from two sources: a sample of patients and carers attending a memory service in south London and a sample of patients and carers from other community services in south London. This included 644 people with a diagnosis of mild/moderate dementia and 689 carers of those with mild/moderate dementia. For the valuation study, the general population sample of 600 respondents was drawn to be representative of the UK general population. Households were sampled in urban and rural areas in northern England and balanced to the UK population according to geodemographic profiles. In the patient/carer valuation study we interviewed a sample of 71 people with mild dementia and 71 family carers drawn from a memory service in south London. Finally, the instruments derived were applied to data from the HTA-SADD (Study of Antidepressants for Depression in Dementia) trial.
This was a complex multiphase study with four linked phases: phase 1 - derivation of the health-state classification system; phase 2 - general population valuation survey and modelling to produce values for every health state; phase 3 - patient/carer valuation survey; and phase 4 - application of measures to trial data.
All four phases were successful and this report details this development process leading to the first condition-specific preference-based measures in dementia, an important new development in this field.
The first limitation relates to the lack of an external data set to validate the DEMQOL-U and DEMQOL-Proxy-U classification systems. Throughout the development process we have made decisions about which methodology to use. There are other valid techniques that could be used and it is possible to criticise the choices that we have made. It is also possible that the use of a mild to moderate dementia sample has resulted in classification systems that do not fully reflect the challenges of severe dementia.
The results presented are sufficiently encouraging to recommend that the DEMQOL instruments be used alongside a generic measure such as the European Quality of Life-5 Dimensions (EQ-5D) in future studies of interventions in dementia as there was evidence that they can be more sensitive for patients at the milder end of disease and some limited evidence that the person with dementia measure may be able to reflect deterioration.
The National Institute for Health Research Health Technology Assessment programme.
Health technology assessment (Winchester, England). 02/2013; 17(5):1-140.
[show abstract][hide abstract] ABSTRACT: The Anti-Clot Treatment Scale (ACTS) is a 15-item patient-reported instrument of satisfaction with anticoagulant treatment. It includes a 12-item ACTS Burdens scale and a 3-item ACTS Benefits scale. Its role in clinical trials and other settings should be supported by evidence that it is both clinically meaningful and scientifically sound. The aim of the study was to evaluate the measurement performance of the ACTS (Dutch, Italian, French, German and English language versions) in patients with venous thromboembolism based on traditional psychometric methods.
ACTS Burdens and Benefits scale data from a large clinical trial (EINSTEIN DVT) involving 1336 people with venous thromboembolism were analysed at both the scale and item level. Five key psychometric properties were examined using traditional psychometric methods: acceptability, scaling assumptions, reliability (including internal consistency reliability, test-retest reproducibility); validity (including known groups and discriminant validity); and responsiveness. These methods of examination underpin the US Food and Drug Administration recommendations for patient-reported outcome instrument evaluation.
Overall, the 12-item ACTS Burdens scale and 3-item ACTS Benefits scale met the psychometric criteria evaluated at both item and scale levels, with the exception of some relatively minor issues in the Dutch language version, which were just below reliability criteria (i.e. alpha = 0.72, test-retest intraclass correlation = 0.79). A consistent finding from item-level evaluations of aggregate endorsement frequencies and skewness suggested that response scales may be improved by reducing the number of response options from five to four.
Both the ACTS Burdens and ACTS Benefits scales consistently satisfied traditional reliability and validity criteria across multiple language datasets, supporting it as a clinically useful patient-reported instrument of satisfaction with anticoagulant treatment in clinical trials.
Health and Quality of Life Outcomes 09/2012; 10:120. · 2.27 Impact Factor
[show abstract][hide abstract] ABSTRACT: To develop a conceptual model representing the impact of musculoskeletal impairments (MSIs) in the lives of children in Malawi.
A total of 169 children with MSIs (CMSIs), family and other community members participated in 57 interviews, focus groups and observations. An inductive approach to data analysis was used to conceptualise the impact of MSIs in children's day-to-day lives.
The main themes that emerged were Indignity, Exclusion, Pain and Hunger. Indignity represents various affronts to children's sense of inherent equal worth as human beings, for example when bullied by peers. Exclusion refers to CMSIs being excluded from three core daily activities: school, play and household chores. Some CMSIs experienced Pain, for example as an outcome of striving to participate. Children with severe mobility impairments were at increased risk of Hunger, having less access to food outside the home and placing a burden of care on the family that could restrict household productivity. Household Poverty was therefore included in the model, as this household impact was inseparable from the impact on CMSIs.
It is recommended that rehabilitation interventions are planned and evaluated with consideration to their impact on Exclusion, Indignity, Pain, Hunger and Household Poverty using multi-faceted partnerships.
Disability and Rehabilitation 03/2012; 34(20):1736-46. · 1.54 Impact Factor
[show abstract][hide abstract] ABSTRACT: Although condition-specific measures are commonly used in dementia, they cannot be used in analyses of cost per quality-adjusted life-year because they do not incorporate preferences. We addressed this gap by estimating two preference-based single index measures: the DEMQOL-U from the self-report DEMQOL (mild-to-moderate dementia severity) and the DEMQOL-Proxy-U from the carer-report DEMQOL-Proxy (all levels of dementia severity).
We conducted valuation studies on 593 members of the general population (306 for the DEMQOL-U, 287 for the DEMQOL-Proxy-U) using the time trade-off elicitation technique. We then fitted a range of mean and individual-level multivariate regression models to the valuation data to derive preference weights for each measure. We applied the estimated weights to a large, clinically representative sample.
Mean observed time trade-off values ranged from 0.18 to 0.95 for DEMQOL-U and from 0.33 to 0.96 for DEMQOL-Proxy-U. The best performing models for each measure were main effects models estimated using individual-level data. DEMQOL-Proxy-U had inconsistent but insignificant coefficient estimates for one dimension. Models were estimated to remove these inconsistencies.
Preference-based single index measures from DEMQOL and DEMQOL-Proxy for use in economic evaluation will enable economic evaluation using quality-adjusted life-years to be undertaken for people across the full range of dementia severity. Future research will examine how the utilities from each measure can be used and combined to populate cost-effectiveness models.
Value in Health 03/2012; 15(2):346-56. · 2.19 Impact Factor
[show abstract][hide abstract] ABSTRACT: Cost-utility analysis is increasingly used to inform resource allocation. This requires a means of valuing health states before and after intervention. Although generic measures are typically used to generate values, these do not perform well with people with dementia. We report the development of a health state classification system amenable to valuation for use in studies of dementia, derived from the DEMQOL system, measure of health-related quality of life in dementia by patient self-report (DEMQOL) and carer proxy-report (DEMQOL-Proxy).
Factor analysis was used to determine the dimensional structure of DEMQOL and DEMQOL-Proxy. Rasch analysis was subsequently used to investigate item performance across factors in terms of item-level ordering, functioning across subgroups, model fit, and severity-range coverage. This enabled the selection of one item from each factor for the classification system. A sample of people with a diagnosis of mild/moderate dementia (n = 644) and a sample of carers of those with mild/moderate dementia (n = 683) were used.
Factor analysis found different five-factor solutions for DEMQOL and DEMQOL-Proxy. Following item reduction and selection by using Rasch analysis, a five-dimension classification for DEMQOL and a four-dimension classification for DEMQOL-Proxy were developed. Each item contained four health state levels.
Combining Rasch and classical psychometric analysis is a valid method of selecting items for dementia health state classifications from both the patient and carer perspectives. The next stage is to obtain preference weights so that the measure can be used in the economic evaluation of treatment, care, and support arrangements for dementia.
Value in Health 03/2012; 15(2):323-33. · 2.19 Impact Factor
[show abstract][hide abstract] ABSTRACT: Pretesting is key in the development of patient-reported outcome (PRO) instruments. We describe a mixed-methods approach based on interviews and Rasch measurement methods in the pretesting of the Pressure Ulcer Quality of Life (PU-QOL) instrument.
We used cognitive interviews to pretest the PU-QOL in 35 patients with pressure ulcers with the view to identifying problematic items, followed by Rasch analysis to examine response options, appropriateness of the item series and biases due to question ordering (item fit). We then compared findings in an interactive and iterative process to identify potential strengths and weaknesses of PU-QOL items, and guide decision-making about further revisions to items and design/layout.
Although cognitive interviews largely supported items, they highlighted problems with layout, response options and comprehension. Findings from the Rasch analysis identified problems with response options through reversed thresholds.
The use of a mixed-methods approach in pretesting the PU-QOL instrument proved beneficial for identifying problems with scale layout, response options and framing/wording of items. Rasch measurement methods are a useful addition to standard qualitative pretesting for evaluating strengths and weaknesses of early stage PRO instruments.
Quality of Life Research 07/2011; 21(3):441-51. · 2.41 Impact Factor
[show abstract][hide abstract] ABSTRACT: Evaluating outcomes such as health-related quality of life is particularly important and relevant in skin conditions such as pressure ulcers where the condition and associated interventions pose substantial burden to patients. Measures to evaluate such outcomes need to be developed by utilising patient-perspective to ensure that content and conceptualisation is relevant to patients.
Our aim was to develop a conceptual framework of health-related quality of life in pressure ulcers, based on patients' views about the impact of pressure ulcers and interventions on health-related quality of life to inform the development of a new patient-reported outcome measure. SETTING, PARTICIPANTS AND METHODS: We developed a working conceptual framework based on a previous review of the literature, then used semi-structured qualitative interviews with 30 adults with pressure ulcers (22-94 years) purposively sampled from hospital, community and rehabilitation care settings in England and Northern Ireland to obtain patients' views, and thematic content analysis and review by a multidisciplinary expert group to develop the final conceptual framework.
Our conceptual model includes four health-related quality of life domains (symptoms, physical functioning, psychological well-being, social functioning), divided into 13 sub-domains and defined by specific descriptive components.
We have identified health-related quality of life outcomes that are important to people with pressure ulcers and developed a conceptual framework using robust and systematic methods, which provides the basis for the development of a new pressure ulcer-specific measure of health-related quality of life.
International journal of nursing studies 12/2010; 47(12):1525-34. · 1.91 Impact Factor
[show abstract][hide abstract] ABSTRACT: The Strengths and Difficulties Questionnaire (SDQ) is a widely used child mental health questionnaire with five hypothesised subscales. There is theoretical and preliminary empirical support for combining the SDQ's hypothesised emotional and peer subscales into an 'internalizing' subscale and the hypothesised behavioral and hyperactivity subscales into an 'externalizing' subscale (alongside the fifth prosocial subscale). We examine this using parent, teacher and youth SDQ data from a representative sample of 5-16 year olds in Britain (N = 18,222). Factor analyses generally supported second-order internalizing and externalizing factors, and the internalizing and externalizing subscales showed good convergent and discriminant validity across informants and with respect to clinical disorder. By contrast, discriminant validity was poorer between the emotional and peer subscales and between the behavioral, hyperactivity and prosocial subscales. This applied particularly to children with low scores on those subscales. We conclude that there are advantages to using the broader internalizing and externalizing SDQ subscales for analyses in low-risk samples, while retaining all five subscales when screening for disorder.
[show abstract][hide abstract] ABSTRACT: Dementia is associated with poor quality of life, but generic measures do not fully capture main aspects of these conditions. Our aim was to validate a Spanish version of the "dementia-specific health-related quality of life" DEMQOL system.
We validated the Spanish DEMQOL and DEMQOL-Proxy in 119 people with dementia from six centers and their caregivers. Patient-reported information, including generic (WHOQOL-BREF) and dementia-specific (DEMQOL) health-related quality of life, depressive symptoms (GDS-15), functional ability (Barthel Index), subjective perception of health and demographic information, was obtained by interview. Proxy-reported information from a family caregiver about the patient's quality of life (DEMQOL-Proxy) was also obtained by interview.
The Spanish DEMQOL showed good psychometric properties. Acceptability (14.3% missing data), internal consistency (Cronbach's alpha = 0.85) and test-retest reliability (ICC = 0.71) were good. A priori hypotheses about the relationship between DEMQOL and the WHOQOL-BREF (psychological and physical domains), GDS-15 and Barthel Index were confirmed, indicating good construct validity. Associations between DEMQOL-Proxy and other measures were weaker. A three-factor solution accounted for 44.4% of the total variance of DEMQOL, and a four-factor solution accounted for 53.3% of the total variance of DEMQOL- Proxy.
The Spanish versions of DEMQOL and DEMQOL-Proxy are reliable and valid in patients with mild/moderate dementia who are living at home.
International Psychogeriatrics 06/2010; 22(4):589-97. · 2.19 Impact Factor
[show abstract][hide abstract] ABSTRACT: To generate anchor-based values for the "minimally important difference" (MID) for a number of commonly used patient-reported outcome (PRO) measures and to examine whether these values could be applied across the continuum of preoperative patient severity.
Six prospective cohort studies of patients undergoing elective surgery at hospitals in England and Wales. Patients completed questionnaires about their health and health-related quality of life before and after surgery. MID values were calculated using the mean change score for a reference group of patients who reported they were "a little better" after surgery minus the mean change score for those who said they were "about the same." Pearson's correlation was used to examine the association between baseline severity and change scores in the reference group. Baseline severity was expressed in two ways: first in terms of preoperative scores and second in terms of the average of pre- and postoperative scores (Oldham's method).
Of the 10 PRO measures examined, eight demonstrated a moderate or high positive association between preoperative scores and MID values. Only two measures demonstrated such an association when Oldham's measure of baseline severity was used.
In general, there is little association between baseline severity and MID values. However, a moderate association persists for some measures, and it is recommended that researchers continue to test for this relationship when generating anchor-based MID values from change scores.
Journal of clinical epidemiology 02/2010; 63(8):865-74. · 2.96 Impact Factor
[show abstract][hide abstract] ABSTRACT: We previously developed the Stroke and Aphasia Quality of Life scale (SAQOL-39) and tested it with people with chronic aphasia. A scale allowing comparisons of quality of life between people with versus without aphasia post-stroke would be of value to clinicians.
To evaluate the psychometrics of the SAQOL-39 in a generic stroke sample. Should this process result in a generic-stroke version of the scale (SAQOL-39g), a further aim is to compare the latter and the SAQOL-39 as tested in chronic aphasia.
Repeated measures psychometric study, evaluating internal consistency, test-retest reliability, construct validity and responsiveness to change. People admitted to hospital with a first stroke were assessed two weeks, three months and six months post stroke.
SAQOL-39, National Institutes of Health Stroke Scale, Barthel, Frenchay Aphasia Screening Test, General Health Questionnaire-12 and Frenchay Activities Index.
Of 126 eligible participants, 96 (76%) participated and 87 (69%) were able to self-report and are presented here. Testing the SAQOL-39 in generic stroke resulted in the SAQOL-39g, which has the same items as the SAQOL-39 but three domains: physical, psychosocial, communication. The SAQOL-39g showed good internal consistency (alpha = 0.95 overall score, 0.92-0.95 domains), test-retest reliability (interclass correlation (ICC) = 0.96 overall, 0.92-0.98 domains), convergent (r = 0.36-0.70 overall, 0.47-0.78 domains) and discriminant validity (r = 0.26 overall, 0.03-0.40 domains). It differentiated people by stroke severity and visual analogue scale (VAS)-defined quality of life. Moderate changes (d = 0.35-0.49; standardized response mean (SRM) = 0.29-0.53) from two weeks to six months supported responsiveness.
The SAQOL-39g demonstrated good reliability, validity and responsiveness to change. It can be used to evaluate quality of life in people with and without aphasia post stroke.
[show abstract][hide abstract] ABSTRACT: The reason some patients with deep venous thrombosis (DVT) develop the postthrombotic syndrome is not well understood.
To determine the frequency, time course, and predictors of the postthrombotic syndrome after acute DVT.
Prospective, multicenter cohort study.
8 Canadian hospital centers.
387 outpatients and inpatients who received an objective diagnosis of acute symptomatic DVT were recruited from 2001 to 2004.
Standardized assessments for the postthrombotic syndrome using the Villalta scale at 1, 4, 8, 12, and 24 months after enrollment. Mean postthrombotic score and severity category at each interval was calculated. Predictors of postthrombotic score profiles over time since diagnosis of DVT were identified by using linear mixed modeling.
At all study intervals, about 30% of patients had mild (score, 5 to 9), 10% had moderate (score, 10 to 14), and 3% had severe (score >14 or ulcer) postthrombotic syndrome. Greater postthrombotic severity category at the 1-month visit strongly predicted higher mean postthrombotic scores throughout 24 months of follow-up (1.97, 5.03, and 7.00 increase in Villalta score for mild, moderate, and severe 1-month severity categories, respectively, vs. none; P < 0.001). Additional predictors of higher scores over time were venous thrombosis of the common femoral or iliac vein (2.23 increase in score vs. distal [calf] venous thrombosis; P < 0.001), higher body mass index (0.14 increase in score per kg/m(2); P < 0.001), previous ipsilateral venous thrombosis (1.78 increase in score; P = 0.001), older age (0.30 increase in score per 10-year age increase; P = 0.011), and female sex (0.79 increase in score; P = 0.020).
Decisions to prescribe compression stockings were left to treating physicians rather than by protocol. Because international normalized ratio data were unavailable, the relationship between anticoagulation quality and Villalta scores could not be assessed.
The postthrombotic syndrome occurs frequently after DVT. Patients with extensive DVT and those with more severe postthrombotic manifestations 1 month after DVT have poorer long-term outcomes.
Annals of internal medicine 11/2008; 149(10):698-707. · 13.98 Impact Factor
[show abstract][hide abstract] ABSTRACT: OBJECTIVES: To develop a practical and scientifically rigorous, patient-based outcome questionnaire to evaluate symptoms in community-acquired pneumonia (CAP). METHODS: The CAP-Symptom questionnaire (CAP-Sym) is an 18-item, interviewer-administered questionnaire that measures the bothersomeness of 18 symptoms during the past 24 hours using a 6-point Likert scale. We used gold-standard psychometric methods to comprehensively evaluate the acceptability, reliability, validity and responsiveness of the CAP-Sym in field testing involving 556 patients in 13 countries. The development and validation of the CAP-Sym were carried out as part of the CAP 2000 study, a multicentre, multinational, prospective, randomised, double-blind study to compare the effectiveness of moxifloxacin oral tablets to standard oral treatment regimes in patients with CAP. RESULTS: Field testing in all countries confirmed the acceptability (item non-response, item endorsement frequencies, item/scale floor and ceiling effects), reliability (internal consistency, item-total and inter-item correlations, test-retest reliability), validity (content, construct, convergent, discriminant, known groups) and responsiveness of the CAP-Sym. CONCLUSIONS: The CAP-Sym is a practical and scientifically sound patient-based outcome measure that can be used to evaluate CAP-related symptoms in clinical trials or clinical audit. The disease-specific CAP-Sym shows preliminary evidence of being more responsive than the generic SF-36 as a measure of outcome in CAP.
Value in Health 10/2008; 4(2):65 - 65. · 2.19 Impact Factor
[show abstract][hide abstract] ABSTRACT: To estimate the cost-effectiveness of a treatment strategy for symptomatic uterine fibroids, which starts with Magnetic Resonance-guided Focused Ultrasound Surgery (MRgFUS) as compared with current practice comprising uterine artery embolisation, myomectomy and hysterectomy.
Cost-utility analysis based on a Markov model.
National Health Service (NHS) Trusts in England and Wales.
Women for whom surgical treatment for uterine fibroids is being considered.
The parameters of the Markov model of the treatment of uterine fibroids are drawn from a series of clinical studies of MRgFUS, and from the clinical effectiveness literature. Health-related quality of life is measured using the 6D. Costs are estimated from the perspective of the NHS. The impact of uncertainty is examined using deterministic and probabilistic sensitivity analysis.
Incremental cost-effectiveness measured by cost per quality-adjusted life-year (QALY) gained.
The base-case results imply a cost saving and a small QALY gain per woman as a result of an MRgFUS treatment strategy. The cost per QALY gained is sensitive to cost of MRgFUS relative to other treatments, the age of the woman and the nonperfused volume relative to the total fibroids volume.
A treatment strategy for symptomatic uterine fibroids starting with MRgFUS is likely to be cost-effective.
BJOG An International Journal of Obstetrics & Gynaecology 05/2008; 115(5):653-62. · 3.76 Impact Factor
[show abstract][hide abstract] ABSTRACT: To evaluate the impact of polymyalgia rheumatica (PMR) on clinical outcomes and quality of life (QOL); the relationship between laboratory measures and clinical outcomes, and changes in QOL; and agreement between rheumatologists in confirming the initial diagnosis.
We conducted a prospective study of 129 participants in 8 hospitals in England who met a modified version of the Jones and Hazleman criteria and had not started steroid therapy. The main outcome measures were response to steroids after 3 weeks (minimum 50% improvement in proximal pain, morning stiffness <30 minutes, acute-phase response not elevated), relapses, QOL as measured by the Short Form 36 and Health Assessment Questionnaire, and diagnosis reassessment at 1 year.
At 3 weeks, 55% of participants failed to meet our definition of a complete response to steroid therapy. Both physical and mental QOL at presentation were substantially lower than general population norms and improved by 12.6 (95% confidence interval [95% CI] 10.8, 14.4) and 11.2 (95% CI 8.5, 13.8) points, respectively, at 1 year. Proximal pain and longer morning stiffness were significantly associated with lower physical QOL during followup, whereas erythrocyte sedimentation rate was most strongly associated with lower mental QOL during followup. There was moderate agreement between clinicians in confirming the PMR diagnosis (kappa coefficients 0.49-0.65).
PMR is a heterogeneous disease with a major impact on QOL. Ongoing monitoring should include disease activity based on symptoms, emergence of alternative diagnoses, and early referral of atypical and severe cases.
[show abstract][hide abstract] ABSTRACT: We identified the need to develop a scientifically rigorous measure of health-related quality of life (HRQL) in dementia that would be appropriate for use at all stages of dementia severity and would be available in both self- and proxy-report versions.
We used standard psychometric methods to eliminate items with poor psychometric properties (item-reduction field test) and to assess the acceptability, reliability and validity of the item-reduced instruments (psychometric evaluation field test). We developed and validated two versions of DEMQOL: a 28-item interviewer-administered questionnaire that is self-reported by the person with dementia (DEMQOL) and a 31-item interviewer-administered questionnaire that is proxy-reported by a caregiver (DEMQOL-Proxy).
DEMQOL shows high reliability (internal consistency and test-retest) and moderate validity in people with mild/moderate dementia. DEMQOL-Proxy shows good acceptability and internal consistency and moderate evidence of validity in people with mild/moderate and severe dementia. Test-retest reliability and performance in people with severe dementia need further testing.
DEMQOL and DEMQOL-Proxy show psychometric properties that are comparable with the best available dementia-specific measures of HRQL. We recommend that DEMQOL and DEMQOL-Proxy are used together. Reliability and validity need to be confirmed in independent samples and responsiveness needs to be evaluated.
Psychological Medicine 06/2007; 37(5):737-46. · 5.59 Impact Factor
[show abstract][hide abstract] ABSTRACT: To assess the validity of VEINES-QOL/Sym, a patient-reported questionnaire to evaluate quality of life and symptoms in patients with deep venous thrombosis (DVT).
Psychometric study within the Venous Thrombosis Outcomes (VETO) Study, a prospective cohort study of long-term outcomes after DVT. A total of 359 English- and French-speaking patients with acute, objectively diagnosed DVT were recruited at seven hospitals in Quebec, Canada. The VEINES-QOL/Sym questionnaire, a 26-item patient-reported measure that generates separate summary scores for symptoms (VEINES-Sym) and quality of life (VEINES-QOL) was evaluated for acceptability, reliability, validity, and responsiveness in VETO Study subjects.
Standard psychometric tests confirmed the acceptability (missing data, item endorsement frequencies, floor and ceiling effects), reliability (internal consistency, item-total and inter-item correlations, test-retest), validity (content, construct, convergent, discriminant, known groups), and responsiveness to clinical change of the VEINES-QOL/Sym in patients with DVT.
The VEINES-QOL/Sym is a practical and scientifically sound patient-reported measure of outcomes that was developed using gold-standard methods. VEINES-QOL/Sym is valid and reliable for use as a measure of quality of life and symptoms in patients with acute DVT and provides a rigorous tool to allow more comprehensive evaluation of outcomes in clinical trials and epidemiological studies of patients with DVT.
Journal of Clinical Epidemiology 11/2006; 59(10):1049-56. · 5.33 Impact Factor
[show abstract][hide abstract] ABSTRACT: We describe a comparison of the responsiveness of three validated instruments when used with patients undergoing coronary bypass surgery (CABG) and angioplasty (PTCA). Patients were randomly selected to receive the Coronary Revascularisation Outcome Questionnaire (CROQ), and either the Seattle Angina Questionnaire (SAQ), or the SF-36 before and 3 months after coronary revascularisation. At total of 199 patients (127 CABG, 72 PTCA) completed the CROQ; 55/72 CABG and 34/38 PTCA patients also completed the SAQ or SF-36, respectively. Effect sizes and standardised response means were calculated as change over the 3-month period for scales measuring similar constructs on each instrument. We used bootstrap estimation to derive 95% confidence intervals for differences in the responsiveness indices. For CABG, the CROQ demonstrated significantly greater change in psychosocial functioning than the SF-36, but less than the SAQ. For PTCA, the CROQ showed greater change for symptoms than the SAQ, but the SAQ was more responsive in terms of physical functioning; and the CROQ showed significantly greater change than the SF-36 for psychosocial functioning. There were no other significant differences between similar scales on the three instruments. In conclusion, the CROQ was as responsive as the disease-specific SAQ and more responsive than the generic SF-36.
Quality of Life Research 09/2006; 15(6):1069-78. · 2.41 Impact Factor