Using mixed methods to select optimal mode of administration for a patient-reported outcome instrument for people with pressure ulcers.

Background: When developing new measuring instruments or deciding upon one for research, consideration of the 'best' method of administration for the target population should be made. Current evidence is inconsistent in differentiating superiority of any one method in terms of quantity and quality of response. We trialed a novel mixed methods approach in early scale development to determine the best administration method for a new patient-reported outcome instrument for people with pressure ulcers (the PU-QOL).

Development and validation of a new patient-reported outcome measure for patients with pressure ulcers: the PU-QOL instrument.

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.

Patient-reported outcome measures for chronic wounds with particular reference to pressure ulcer research: a systematic review.

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.

The Anti-Clot Treatment Scale (ACTS) in clinical trials: cross-cultural validation in venous thromboembolism patients.

Background: 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.

Estimating preference-based single index measures for dementia using DEMQOL and DEMQOL-Proxy.

Objective: 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).

Methods: 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.

Improving the measurement of QALYs in dementia: developing patient- and carer-reported health state classification systems using Rasch analysis.

Objectives: 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.

When to use broader internalising and externalising subscales instead of the hypothesised five subscales on the Strengths and Difficulties Questionnaire (SDQ): data from British parents, teachers and children.

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).

Development of a conceptual framework of health-related quality of life in pressure ulcers: a patient-focused approach.

Background: 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.

Objectives: 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.

Validation of the Spanish version of the DEMQOL system.

Background: 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.

Methods: We validated the Spanish DEMQOL and DEMQOL-Proxy in 119 people with dementia from six centers and their caregivers.

Mathematical coupling may account for the association between baseline severity and minimally important difference values.

Objective: 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.

Study Design And Setting: 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.

Psychometric properties of the Stroke and Aphasia Quality of Life Scale (SAQOL-39) in a generic stroke population.

Background: 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.

Objectives: To evaluate the psychometrics of the SAQOL-39 in a generic stroke sample.

Determinants and time course of the postthrombotic syndrome after acute deep venous thrombosis.

Background: The reason some patients with deep venous thrombosis (DVT) develop the postthrombotic syndrome is not well understood.

Objective: To determine the frequency, time course, and predictors of the postthrombotic syndrome after acute DVT.

Design: Prospective, multicenter cohort study.

Clinical outcomes, quality of life, and diagnostic uncertainty in the first year of polymyalgia rheumatica.

Objective: 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.

Methods: 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.

VEINES-QOL/Sym questionnaire was a reliable and valid disease-specific quality of life measure for deep venous thrombosis.

Objective: 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).

Study Design And Setting: 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.

Responsiveness of the coronary revascularisation outcome questionnaire compared with the SF-36 and Seattle Angina Questionnaire.

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.

A brief measure of perceived understanding of informed consent in a clinical trial was validated.

Background And Objective: To develop and evaluate an Informed Consent Questionnaire (ICQ) for measuring self-reported perceived understanding of informed consent in a randomized clinical trial.

Methods: The study was embedded in a Department of Veterans Affairs randomized clinical trial of Gulf War veterans' illnesses (CSP#470). The trial was initiated in May 1999 at 20 hospitals and concluded in September 2001; 1,092 participants were enrolled and followed for 12 months.

What constitutes health-related quality of life in dementia? Development of a conceptual framework for people with dementia and their carers.

Background: The evaluation of multi-dimensional outcomes such as health-related quality of life (HRQL) is particularly relevant in dementia where the disease can compromise all areas of functioning. The nature of dementia can make self-report difficult, yet the subjective nature of HRQL makes the value of proxy reports limited. Previous work suggests that there are domains of HRQL that are unique to dementia.

Prospective evaluation of health-related quality of life in patients with deep venous thrombosis.

Background: To our knowledge, the burden of deep venous thrombosis from the patient's perspective has not been quantified. We evaluated health-related quality of life (QOL) after deep vein thrombosis and compared results with general population norms.

Methods: This was a multicenter prospective cohort study of 359 consecutive eligible patients with deep vein thrombosis recruited at 7 Canadian hospital centers.

The psychological impact of terrorism: an epidemiologic study of posttraumatic stress disorder and associated factors in victims of the 1995-1996 bombings in France.

Objective: A wave of bombings struck France in 1995 and 1996, killing 12 people and injuring more than 200. The authors conducted follow-up evaluations with the victims in 1998 to determine the prevalence of and factors associated with posttraumatic stress disorder (PTSD).

Method: Victims directly exposed to the bombings (N=228) were recruited into a retrospective, cross-sectional study.

Relationship between clinical classification of chronic venous disease and patient-reported quality of life: results from an international cohort study.

Objectives: The CEAP (clinical, etiologic, anatomic, pathophysiologic) clinical classification for chronic venous disease (CVD) is based on physician-evaluated clinical signs of CVD. The relationship between CEAP clinical classification and patient-perceived quality of life (QOL) has not been evaluated, but is important for the selection and interpretation of outcomes in clinical studies of patients with CVD. The purpose of this study was to evaluate whether CVD, as classified with CEAP, is related to patient-reported QOL, and to identify patient characteristics associated with CEAP class and QOL that need to be considered when interpreting outcomes in CVD.

Costs of dialysis for elderly people in the UK.

Background: Growing acceptance rates of elderly patients for dialysis requires a careful planning of renal services expansion. As little is known about the actual resource use in patients 70 years and over, we evaluated the entire range of costs related to treatment, hospitalization, medication and other health and social service use, and assessed the impact of socio-demographic and clinical factors on costs.

Methods: Service use and costs were assessed in a 12-month prospective cohort study of 171 dialysis patients, 70 years of age and over, from four hospital-based renal units in London, UK.

Evaluation of outcomes in community-acquired pneumonia: a guide for patients, physicians, and policy-makers.

Community-acquired pneumonia (CAP) is a key target for research and quality improvement in acute medicine. However, many of the outcome measures used in prognostic and antibiotic studies are not validated and do not capture features of outcome that are important to patients. Substitutes for traditional outcome measures include a recently validated patient-based symptom questionnaire (the CAP-Sym) and process-of-care measures.

Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39): evaluation of acceptability, reliability, and validity.

Background And Purpose: Health-related quality of life (HRQL) is a key outcome in stroke clinical trials. Stroke-specific HRQL scales (eg, SS-QOL, SIS) have generally been developed with samples of stroke survivors that exclude people with aphasia. We adapted the SS-QOL for use with people with aphasia to produce the Stroke and Aphasia Quality of Life Scale (SAQOL).

Evaluation of outcomes in chronic venous disorders of the leg: development of a scientifically rigorous, patient-reported measure of symptoms and quality of life.

Objective: The purpose of this study was to develop a practical and scientifically rigorous, patient-reported outcome measure to evaluate quality of life and symptoms across the range of conditions (eg, telangiectasias, varicose veins, edema, skin changes, leg ulcers) in chronic venous disorders of the leg (CVDL).

Methods: This study was a psychometric study within the VEnous INsufficiency Epidemiological and Economic Study (VEINES), an international, prospective cohort study to evaluate clinical outcomes, quality of life, costs, and use of health services in CVDL. The study was set in the 166 general practices and 116 specialist clinics in Belgium, France, Italy, and Canada (Quebec) that participated in the VEINES study plus in additional specialist clinics in Ottawa and Montreal.