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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.

OBJECTIVES: To survey of the structure, processes and organisation of renal satellite units (RSUs) in England and Wales (Phase 1), and to compare the effectiveness, acceptability, accessibility and economic impact of chronic haemodialysis performed in RSUs compared to main renal units (MRUs) (Phase 2). DATA SOURCES: Phase 1: all renal satellite units in England and Wales. Phase 2: haemodialysis patients in a representative sample (based on geography, site, private--public ownership, medical input) of 12 RSUs and their MRUs. REVIEW METHODS: Phase 1 consisted of a questionnaire survey. Semi-structured interviews were held in a representative sample of 24 RSUs with the senior clinician, senior nurse and manager. Phase 2 consisted of a cross-sectional comparison of patients in these RSUs and patients in the parent MRUs deemed suitable for satellite care by senior staff. Clinical information was obtained from medical notes and unit computer systems. Generic and disease specific health-related quality of life (HRQoL) measures were used. Co-morbidity was assessed by the Wright/Khan Index, the Lister/Chandna score, the Modified Charlson Index, and the Karnofsky Performance Score. Statistical analyses compared RSU versus MRU patients and took account of the paired and clustered nature of the data. RESULTS: In Phase 1, responses were received from 74/80 (93%) of RSUs; 2600 patients were being treated in these RSUs. The interviews were generally positive about the impact of RSUs in terms of improved accessibility and a better environment for chronic haemodialysis (HD) patients, and in expanding renal replacement therapy patients (RRT) capacity. In Phase 2, some 82% of eligible patients took part, 394 patients in the 12 RSUs and 342 in the parent MRUs. The response rate was similar in both groups. There were no significant differences in clinical processes of care. Most clinical outcomes were similar, especially after pooled analysis, although a few parameters were statistically significantly different -- notably the proportion achieving Renal Association Standards for adequacy of dialysis as measured by the urea reduction ratio (URR) was higher in the RSU patients. Patient-specific quality of life did not differ except on the patient satisfaction questions from the KDQOL, which were scored higher by the RSU sample. Strength of preference for health status on and off dialysis was very similar between the groups, as were EQ-5D utilities. Major adverse events were not common in the RSU patients, although there were many hypotensive episodes on HD, a proportion of which affected the duration of the HD session. Of the costs measured, the only difference that was statistically significant was for District Nurse visits. Of particular note was that despite the MRU group having a higher proportion of patients hospitalised, this did not translate into a statistically significant budgetary impact in terms of the total cost per patient of hospitalisations or mean cost per patient per hospitalisation. CONCLUSIONS: This study has shown that RSUs are an effective alternative to MRU HD for a wide spectrum of patients. They improve geographic access for more dispersed areas and reduce patients' travel time, and are generally more acceptable to patients on several criteria. There does not seem to be an adverse impact of care in the RSUs although comparative long-term prospective data are lacking. The evidence suggests that satellite development could be successfully expanded; not all MRUs have any satellites and many have only a few. No single RSU model can be recommended but key factors would include local geography, the likely catchment population and the type of patients to be treated. There is a need for more basic budgetary information linking activity and expenditure to be available and more transparent, to perform at least an insightful top-down costing of the two care settings. Other areas suggested for further research include: a comparison of adverse events occurring in MRUs and RSUs with longer duration and larger numbers to identify more severe events, along with the more research into the scope for preventing such events, and a study into the patients deemed ineligible for satellite care. International comparisons of satellite care would also be useful.

PurposeA psychometrically validated measure is needed to evaluate outcomes in carers of people with mental health problems, including dementia. This study aims to develop and validate the Carer well‐being and support questionnaire (CWS).Design/methodology/approachDevelopment and evaluation of the measure was conducted in three phases. The authors deconstructed an existing questionnaire (CUES‐C) to produce a long version measure. This was trialed with carers to reduce the number of items and a preliminary evaluation of the psychometric properties of the remaining items was undertaken. A second field test was conducted with the item‐reduced questionnaire measure to evaluate acceptability, reliability and validity.FindingsThe CWS well‐being scale shows moderate acceptability and good reliability and validity. The CWS support scale shows moderate acceptability and good reliability; validity testing for the support scale is limited by the lack of appropriate validating measures.Practical implicationsThe CWS is a reliable, valid measure of carer well‐being and support, reflecting important aspects of carers' lives.Originality/valueThis paper provides researchers and practitioners with a tool that can be used to measure and address areas of support for carers. This is important in assessing the effectiveness of new interventions and approaches.

PURPOSE: To develop a conceptual model representing the impact of musculoskeletal impairments (MSIs) in the lives of children in Malawi. METHOD: 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. RESULTS: 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. CONCLUSION: 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.

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. 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). Methods: 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. Results: 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. Conclusion: 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. Copyright © 2012, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc.

Summary. Background: Few studies have evaluated the long-term economic consequences of deep vein thrombosis (DVT).None of them have incorporated prospectively collectedclinical data to ensure accurate identification of incident casesof DVT and DVT-related health outcomes of interest, such aspost-thrombotic syndrome (PTS). Objectives: To prospectivelyquantify medical and non-medical resource use and costsrelated to DVT during 2 years following diagnosis, and toidentify clinical determinants of costs. Methods: Three hun-dred and fifty-five consecutive patients with acute DVT wererecruited at seven Canadian hospital centers. Resource use andcost information were retrieved from three sources: weeklypatient-completed cost diaries, nurse-completed case reportforms, and the Quebec provincial administrative healthcaredatabase (RAMQ). Results: The rate of DVT-related hospi-talization was 3.5 per 100 patient-years (95% confidenceinterval [CI] 2.2–4.9). Patients reported a mean (standarddeviation) of 15.0 (14.5) physician visits and 0.7 (1.2) otherhealthcare professional visits. The average cost of DVT was$5180 (95% CI $4344–6017) in Canadian dollars, with 51.6%of costs being attributable to non-medical resource use.Multivariate analysis identified four independent predictorsof costs: concomitant pulmonary embolism (relative increasein cost [RIC] 3.16; 95% CI 2.18–4.58), unprovoked DVT(RIC 1.65; 95% CI 1.28–2.13), development of PTS duringfollow-up (RIC 1.35; 95% CI 1.05–1.74), and management ofDVT in the inpatient setting (RIC 1.79; 95% CI 1.33–2.40).Conclusions: The economic burden of DVT is substantial. Theuse of measures to prevent the occurrence of PTS andfavoring outpatient care of DVT has the potential to diminishcosts.Keywords: cohort study, cost determinants, deep vein throm-bosis, economic burden, post-thrombotic syndrome.IntroductionDeepveinthrombosis(DVT)isacommonandseriousvascularcondition[1].TheclinicalburdenofDVToftenextendsbeyondthe initial event, with increased risks of recurrent venousthromboembolism (VTE), bleeding while on anticoagulanttherapy, and development of the chronic post-thromboticsyndrome (PTS).Few studies have evaluated the long-term economic conse-quences of DVT. Studies to date have relied on retrospectiveadministrative claims database analysis [2–5] or Markovmodeling [6], and assessed medical costs only. Non-medicalcosts, including productivity losses that impact on patients,their families, and society, have not been adequately consid-ered. None has incorporated prospectively collected clinicaldata to ensure accurate identification of incident cases of DVTand DVT-related health outcomes of interest, such as PTS.We conducted a study to prospectively quantify medicaland non-medical costs associated with DVT during the

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.

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. 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. Findings 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. Conclusions 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.

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. 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). Results 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. Conclusion 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.

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. 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.Results: The Spanish DEMQOL showed good psychometric properties. Acceptability (14.3% missing data), internal consistency (Cronbach's α = 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.Conclusion: The Spanish versions of DEMQOL and DEMQOL-Proxy are reliable and valid in patients with mild/moderate dementia who are living at home.

Summary. Background/objectives: We prospectively measured change in quality of life (QOL) during the 2 years after a diagnosis of deep vein thrombosis (DVT) and evaluated determinants of QOL, including development of the post-thrombotic syndrome (PTS). Patients/methods: Consecutive patients with acute DVT were recruited from 2001 to 2004 at eight hospitals in Canada. At study visits at baseline, and 1, 4, 8, 12 and 24 months, clinical data were collected, standardized PTS assessments were performed, and QOL questionnaires were self-completed. Generic QOL was measured using the Short-Form Health Survey-36 (SF-36) questionnaire. Venous disease-specific QOL was measured using the Venous Insufficiency Epidemiological and Economic Study (VEINES)-QOL/Sym questionnaire. The change in QOL scores over a 2-year follow-up was assessed. The influence of PTS and other characteristics on QOL at 2 years was evaluated using multivariable regression analyses. Results: Among the 387 patients recruited, the average age was 56 years, two-thirds were outpatients, and 60% had proximal DVT. The cumulative incidence of PTS was 47%. On average, QOL scores improved during follow-up. However, patients who developed PTS had lower scores at all visits and significantly less improvement in QOL over time (P-values for PTS*time interaction were 0.001, 0.012, 0.014 and 0.006 for PCS, MCS, VEINES-QOL and VEINES-Sym). Multivariable regression analyses showed that PTS (P

Nous décrivons ici un programme d'intervention psychosociale conçu pour mieux traiter le stress associé à l'infection du VIH. Le programme d'intervention NUCARE se fonde sur six composantes : restructuration cognitive, résolution de problèmes, relaxation, détermination d'objectifs, soutien social et utilisation de ressources et de services. Nous décrivons ici la logique et le développement de l'intervention, et présentons des exemples concrets pour illustrer les avantages de chacune de ses composantes., We describe a psychosocial intervention program designed to enhance coping with the stress associated with HIV infection. The NUCARE intervention program is based on six components of coping including: cognitive refraining, problem-solving, relaxation, goal setting, social support and use of resources and services. The rationale and development of the intervention is discussed and practical case examples illustrating the benefits of each component are presented.

Background The use of central venous catheters for vascular access in hemodialysis (HD) patients is associated with an increased risk of complications compared to arteriovenous fistulas (AVF). Despite this, catheter use remains high and patient satisfaction may be an important driver of catheter use. Methods We developed the Vascular Access Questionnaire (VAQ) to measure patient-reported views of their vascular access. Chronic HD patients at two centers were asked to rate how bothered they were by 17 access-related problems. VAQ symptom scores were compared between patients using catheters and those using fistulas for vascular access. Results Two hundred and twenty-two patients were eligible for the study. Symptom score was not different between patients using catheters and those using fistulas (p=0.36). However, patients using fistulas were more likely to be at least moderately bothered by pain, bleeding, bruising, swelling, and the appearance of their access than patients using catheters. Elderly patients reported lower symptom scores with catheters than fistulas. Conclusions Patients appear to be primarily concerned with the appearance of their access and cannulation-related complications, particularly the elderly. Better education about the risk of adverse events with catheters and the implementation of measures aimed at reducing cannulation-related complications may help to increase fistula rates and improve patient satisfaction with their vascular access.

Peritoneal dialysis (PD) may be declining because the elderly often have barriers to self-care PD. The objective of this study was to determine whether the availability of home care increases utilization of PD. In 134 incident chronic dialysis patients (median age 73), 108 (81%) had at least one medical or social condition, which was a potential barrier to self-care PD. Eighty percent of patients living in regions where home care was available were considered eligible for PD compared to 65% in regions without home care (P=0.01, adjusted). Each barrier reduced the probability of being eligible for PD by 26% (odds ratio 0.74, per condition, P=0.02) adjusted for age, sex, predialysis care, in-patient start, and availability of home care. In regions with and without home care, 59 and 58% of eligible patients choose PD when they were offered it (P=NS). The utilization of PD in the incident end-stage renal disease (ESRD) population living in regions with and without home care was 47 and 37%, respectively (P=0.27). The mean rate of home care visits over the first year was 4.3 per week (maximum available was 14 per week). Of the 22 assisted patients, 15 required chronic support, five graduated to self-care, and two started with self-care but later required assistance. Adverse events were similar between assisted PD and traditional modalities. Barriers to self-care PD are very common in the elderly ESRD population but home care assistance significantly increases the number of patients who can be safely offered PD.

Introduction When assessing health-related quality of life (HRQL), critical care outcomes research generally uses generic measures in the absence of a suitable critical care–specific measure. Our aims were to construct a conceptual framework of survivors' HRQL and assess the extent to which the 2 most commonly used generic measures (the Short Form 36 Health Survey and EuroQol-5D) covered the framework. Methods A preliminary framework for survivors' HRQL was constructed based on a systematic literature review and on a secondary analysis of 40 existing in-depth interviews with adult, critical care survivors. Its adequacy was then tested using new in-depth interviews with a maximum variation sample of critical care survivors. The extent of coverage of the final framework by the 2 generic HRQL instruments was then evaluated in 2 ways: by comparison with critical care survivors' accounts from the new in-depth interviews and by eliciting survivors' views on the adequacy of the 2 generic HRQL instruments using cognitive debriefing. Results The final framework recognized 3 aspects of health status that affected 9 areas of life. The 2 most commonly used generic measures had substantial gaps in their coverage of the framework of survivors' HRQL. Conclusions The findings argue strongly for a new critical care–specific HRQL measure.

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.

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. The reliability and validity sample included 1,086 participants evaluated at baseline, 906 at 3 months, 929 at 6 months, and 910 at 12 months. The psychometric evaluations included tests of acceptability (based on missing data, endorsement frequencies, and floor/ceiling effects), item reduction, internal consistency, and construct validity (based on Cronbach's alpha coefficients, item-total correlations, and principal components analysis). Results The ICQ had >5% missing information on some questions at baseline, indicating poor acceptability prior to the initiation of the trial; however, the scale had good acceptability at each of the follow-up visits. Psychometric evaluation following standard item reduction techniques confirmed the reliability and validity of a four-item subscale of the ICQ (ICQ-4). Conclusions The ICQ-4 is a simple and psychometrically sound self-report measure of perceived understanding of informed consent.

Objective: To develop and evaluate the acceptability, reliability, validity, and responsiveness of the Indian vision function questionnaire (IND-VFQ). Methods: Problem statements from previous qualitative studies were reduced to a 45 item interviewer administered questionnaire representing three a priori domains (general functioning, psychosocial impact, and visual symptoms) which was evaluated in patients with cataract (n = 420), glaucoma (n = 120), diabetic retinopathy, or age related macular degeneration (n = 120) and normal controls (n = 120). Standard methods were used for item reduction and to evaluate psychometric properties. Results: Psychometric item reduction produced a 33 item questionnaire. Psychometric evaluation showed that two of the three scales (psychosocial impact and visual symptoms) had good acceptability, and that all three scales showed high internal consistency (alpha >0.80; item-total correlations 0.54–0.86) and test-retest reliability (>0.89). All three scales showed moderate evidence of convergent and discriminant validity. Responsiveness, assessed in cataract patients (n = 120) before and after surgery, was good for all three scales (effect sizes >1). Conclusions: The IND-VFQ33 is a psychometrically sound measure of vision function addressing a gap in patient defined measures of vision function developed in populations living in low income countries.

Objective: To describe the development and scientific validation of a new patient based measure, the coronary revascularisation outcome questionnaire (CROQ), to evaluate health outcomes and quality of life before and after coronary artery bypass grafting and percutaneous transluminal coronary angioplasty. Design and setting: Psychometric validation study conducted with patients from three hospitals in the UK. Patients: Two independent field tests were conducted by postal survey of 714 patients before and 1329 patients after coronary revascularisation to evaluate the measurement properties of the CROQ. Methods: Qualitative methods including patient interviews were used to develop questionnaire content. A full psychometric evaluation was performed on the survey data. Results: Psychometric tests with the application of stringent criteria confirmed the acceptability (low missing data, good response rates), scaling assumptions (good item convergent and discriminant validity), reliability (good internal consistency and reproducibility), validity (good content and construct validity), and responsiveness of the CROQ. Conclusions: The CROQ is a practical and scientifically sound patient based measure of outcome developed using psychometric methods. It captures aspects of recovery not addressed in other cardiac questionnaires and has been shown to be a highly responsive instrument that will be useful in evaluating outcomes in clinical trials.

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).Victims directly exposed to the bombings (N=228) were recruited into a retrospective, cross-sectional study. Computer-assisted telephone interviews were conducted to evaluate PTSD, per DSM-IV criteria, and to assess health status before the attack, initial injury severity and perceived threat at the time of attack, and psychological symptoms, cosmetic impairment, hearing problems, and health service use at the time of the follow-up evaluation. Factors associated with PTSD were investigated with univariate logistic regression followed by multiple logistic regression analyses.A total of 196 respondents (86%) participated in the study. Of these, 19% had severe initial physical injuries (hospitalization exceeding 1 week). Problems reported at the follow-up evaluation included attack-related hearing problems (51%), cosmetic impairment (33%), and PTSD (31%) (95% confidence interval=24.5%-37.5%). Results of logistic regression analyses indicated that the risk of PTSD was significantly higher among women (odds ratio=2.54), participants age 35-54 (odds ratio=2.83), and those who had severe initial injuries (odds ratio=2.79) or cosmetic impairment (odds ratio=2.74) or who perceived substantial threat during the attack (odds ratio=3.99).The high prevalence of PTSD 2.6 years on average after a terrorist attack emphasizes the need for improved health services to address the intermediate and long-term consequences of terrorism.

Background: The prevalence rate of renal replacement therapy in the United Kingdom has increased significantly, particularly by long-term hemodialysis (HD) therapy in renal satellite units (RSUs). These are largely nurse-run units linked to main renal units (MRUs). We compared outcomes, processes of care, and costs in RSUs with those in MRUs. Methods: A cross-sectional comparison was performed of HD patients from a representative sample of 12 RSUs in England and Wales and HD patients in the linked MRUs deemed suitable by the senior nurse for RSU care. Data for patient characteristics, clinical process and outcome measures, health-related quality of life (HRQoL), and patient satisfaction were collected. A partial analysis of National Health Service and social care costs was undertaken. Geographic access was assessed by road time and distance traveled to dialysis sessions. Results: Seven hundred thirty-six of 895 eligible patients (82%) participated. RSU patients were older (mean age, 63 versus 57 years), but had comorbidity similar to that of MRU patients. There were no significant differences in most processes of care or clinical outcomes; achievement of standards for adequacy of dialysis (urea reduction ratio) was significantly greater in RSU patients and hospitalization in the last year was less frequent. Patient HRQoL was similar, but patient satisfaction was greater in RSU patients. RSU patients potentially saved 19 minutes traveling for each dialysis session. Costs for routine dialysis and health/social care were similar. Conclusion: RSUs appear to be as effective as main HD units for a wide spectrum of patients, improve geographic access, and are more acceptable to patients. There is evidence that they are as cost-effective as main units.

ObjectivesThe 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.MethodsThe Venous Insufficiency Epidemiologic and Economic Study (VEINES) population is an international cohort of 1531 patients with CVD recruited in Belgium, France, Italy, and Canada. At the baseline visit patients were categorized into one of seven CEAP clinical categories on the basis of a clinical examination, and completed standardized generic (Short-Form Health Survey, 36 items [SF-36]) and venous disease–specific (QOL [VEINES-QOL] and symptom severity [VEINES-Sym]) QOL questionnaires. Multivariate analyses were used to examine the relationship between CEAP class and QOL.ResultsThe proportion of patients in the seven CEAP classes (class 0-6) was 3.8%, 13.3%, 24.1%, 12.8%, 36.4%, 7.3%, and 2.3%, respectively. In univariate analyses, SF-36 Physical Component Summary scores and VEINES-QOL and VEINES-Sym scores decreased significantly (ie, poorer QOL) with increasing CEAP class. Multivariate analyses controlling for age, sex, country, education, body mass index, years since CVD onset and comorbid conditions confirmed findings for VEINES-QOL and VEINES-Sym (P < .0001 and P < .0001, respectively).ConclusionsPhysician-evaluated clinical category, based on the CEAP classification, predicts patient-reported QOL and symptom severity in CVD.

Objective: To develop a patient-based measure of walking ability in MS. Methods: Twelve items describing the impact of MS on walking (12-Item MS Walking Scale [MSWS-12]) were generated from 30 patient interviews, expert opinion, and literature review. Preliminary psychometric evaluation (data quality, scaling assumptions, acceptability, reliability, validity) was undertaken in the data generated by 602 people from the MS Society membership database. Further psychometric evaluation (including comprehensive validity assessment, responsiveness, and relative efficiency) was conducted in two hospital-based samples: people with primary progressive MS (PPMS; n = 78) and people with relapses admitted for IV steroid treatment (n = 54). Results: In all samples, missing data were low (≤3.8%), item test–retest reproducibility was high (≥0.78), scaling assumptions were satisfied, and reliability was high (≥0.94). Correlations between the MSWS-12 and other scales were consistent with a priori hypotheses. The MSWS-12 (relative efficiency = 1.0) was more responsive than the Functional Assessment of Multiple Sclerosis mobility scale (0.72), the 36-Item Short Form Health Survey physical functioning scale (0.33), the Expanded Disability Status Scale (0.03), the 25-ft Timed Walk Test (0.44), and Guy’s Neurologic Disability Scale lower limb disability item (0.10). Conclusions: The MSWS-12 satisfies standard criteria as a reliable and valid patient-based measure of the impact of MS on walking. In these samples, the MSWS-12 was more responsive than other walking-based scales.

Study objectives To develop and validate a patient-based outcome measure to evaluate symptoms in patients with community-acquired pneumonia (CAP). Design A psychometric study within an international, prospective, randomized, double-blind study. The CAP-symptom questionnaire (CAP-Sym) is a new, 18-item, patient-reported outcome measure that evaluates the bothersomeness of CAP-related symptoms during the past 24 h 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. Setting Sixty-four centers in 13 countries (France, Germany, Hungary, Israel, Italy, Norway, Poland, Portugal, South Africa, Spain, Sweden, Switzerland, United Kingdom). Patients Five hundred fifty-six patients with CAP, recruited from outpatient clinics, general practice, and hospital centers. Interventions Randomization 1:1 to moxifloxacin (400 mg once daily), oral or standard oral treatment (amoxicillin, 1 g tid, or clarithromycin, 500 mg bid), alone or in combination, for up to 14 days. Results Standard psychometric tests confirmed the acceptability (item nonresponse, 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 of CAP-related symptoms that has been developed using "gold standard" methods. As the only fully validated measure of symptoms in patients with CAP, which is quick and easy to administer and is more responsive than the generic Medical Outcomes Study 36-Item Short-Form Health Survey, the CAP-Sym provides a practical and rigorous method for improving the evaluation of outcomes in clinical trials and audit.

Purpose: This study assessed the impact of varicose veins (VV) on quality of life (QOL) and patient-reported symptoms. Methods: A cross-sectional population-based study was held in 166 general practices and 116 specialist clinics for venous disorders of the leg in Belgium, Canada (Quebec), France, and Italy. Study subjects included a sample of 259 reference patients without VV (CEAP class 0 or 1) and 1054 patients with VV who were classified as having VV alone (367; 34.8%), VV with edema (125; 11.9%), VV with skin changes (431; 40.9%), VV with healed ulcer (100; 9.5%), and VV with active ulcer (31; 2.9%). The main outcome measure was generic and disease-specific QOL, as measured by means of the Short-Form Health Survey-36 (SF-36) and the VEINES-QOL scale, and patient-reported symptoms as measured by the VEINES-SYM scale. Results: In patients with VV, age-standardized mean SF-36 physical (PCS) and mental (MCS) scores were 45.6 and 46.1 in men and 44.2 and 43.2 in women, respectively, compared with population norms of 50. PCS scores decreased according to increasing severity of concomitant venous disease, with the lowest mean scores of 37.3 and 35.5 found in patients with VV and active ulcer. However, adjusted analyses showed no statistically significant differences between patients with VV alone and patients without VV for PCS (0.0), MCS (1.0), VEINES-QOL (–0.1), or VEINES-SYM (0.0) scores. In comparison with patients without VV, the largest differences were seen in patients with VV and edema (PCS, VEINES-QOL, and VEINES-SYM score differences of –1.8, –2.5, and –2.9, respectively) and in patients with VV and ulceration (differences of –3.3, –3.4, and –2.7, respectively). The high prevalence of major symptoms of venous disorders in patients in CEAP class 0 or 1 being treated for venous disorders (76.1% of patients had heaviness, aching legs, or swelling) might have contributed to the impairment of QOL in the reference group. Conclusion: Results indicate that impairment in physical QOL in patients with VV is associated with concomitant venous disease, rather than the presence of VV per se. Findings concerning QOL in patients with VV can only be reliably interpreted when concomitant venous disease is taken into account. In patients with VV alone, the objectives of cosmetic improvement and the improvement of QOL should be considered separately. (J Vasc Surg 2001;34:641-8.)

Changes in health policy have underlined the importance of evidence-based clinical practice and rigorous evaluation of patient-based outcomes. As patient-based outcome measurement is particularly important in treatment trials of multiple sclerosis, a number of disease-specific instruments have been developed recently. One limitation of these instruments is that none was developed using the standard psychometric approach of reducing a large item pool generated from people with multiple sclerosis. Consequently, an outcome measure for clinical trials of multiple sclerosis that is disease specific and combines patient perspective with rigorous psychometric methods will complement existing instruments. The aim of this study was to develop such a measure. Standard psychometric methods were used. A pool of 129 questionnaire items was generated from interviews with 30 people with multiple sclerosis, expert opinion and literature review. The questionnaire was administered by postal survey to 1530 people selected randomly from the Multiple Sclerosis Society membership database. Redundant items and those with limited measurement properties were removed. The remaining items (n = 41) were grouped into scales using factor analysis, and then refined to form the Multiple Sclerosis Impact Scale (MSIS-29), an instrument measuring the physical (20 items) and psychological (nine items) impact of multiple sclerosis. Five psychometric properties of the MSIS-29 (data quality, scaling assumptions, acceptability, reliability and validity) were examined in a separate postal survey of 1250 Multiple Sclerosis Society members. A preliminary responsiveness study of the MSIS-29 was undertaken in 55 people admitted for rehabilitation and intravenous steroid treatment of relapses. The MSIS-29 satisfied all psychometric criteria. Data quality was excellent, missing data were low (maximum 3.9%), item test-re-test reliability was high (r = 0.65-0.90) and scale scores could be generated for >98% of respondents. Item descriptive statistics, item convergent and discriminant validity, and factor analysis indicated that it was legitimate to generate scores for MSIS-29 scales by summing items. MSIS-29 scales showed good variability, small floor and ceiling effects, high internal consistency (Cronbach's alpha

Qualitative and quantitative methods can be used to evaluate women's views of maternity care in order to provide patient-based evidence about what constitutes a quality service. Qualitative methods provide rich data about the views, experiences and preferences of individual patients. However, as numeric estimates are often required to detect change or improvement and to make other comparisons, quantitative methods provide an alternative and complementary strategy in quality assessment. This paper outlines the relative advantages and disadvantages of qualitative and quantitative methods of evaluating women's satisfaction with maternity care, comprehensively reviews quantitative measures which can be used, and provides guidelines to help decide the most appropriate method to use.

BACKGROUND Patients with uveal melanoma can be treated by a number of modalities. As none of the different treatments offer a survival advantage, a key factor in choosing among treatments is their differential impact on patients9 quality of life. A short, patient based questionnaire was developed and validated for evaluating outcomes following treatment for uveal melanoma. METHODS The 21 item measure of outcome in ocular disease (MOOD) assesses the patient9s view of outcome in terms of visual function and the impact of treatment. The reliability and validity of the three MOOD scores (total, vision, impact) were evaluated in 176 patients who had been treated for uveal melanoma (75 brachytherapy, 78 proton beam radiotherapy, 23 enucleation). Of these, 165 patients also completed the SF-36. RESULTS All three MOOD scales met standard criteria for acceptability, reliability, and validity. The proportion of missing data was low, and responses to all items were well distributed across response categories. Internal consistency, assessed by Cronbach9s alpha coefficients, exceeded the standard criterion of 0.70 for all three summary scores. Item total correlations ranged from 0.22 to 0.77 (mean item total correlation 0.58), indicating good homogeneity. Test-retest correlations for all three summary scores exceeded 0.85. Scaling assumptions, assessed by item convergent and discriminant validity correlations, were met for the vision and impact scores. The MOOD showed good content validity, as assessed by review by ophthalmologists and patients. Construct validity was demonstrated by high intercorrelations between the vision and impact scores and the total scale; higher scores for patients who reported being very satisfied compared with those who were not very satisfied and for those who reported persistent red eye compared with those who did not have this complication (known group differences/hypothesis testing); moderate correlations between the MOOD and the SF-36 and visual acuity (convergent validity); and low correlations between the MOOD and age and sex (discriminant validity). CONCLUSIONS The MOOD is a practical and scientifically sound patient based measure which can be used in research and audit to evaluate outcomes following treatment for uveal melanoma. It takes 5 minutes to complete and meets standard psychometric criteria for reliability and validity.

In his book ‘Effectiveness and Efficiency’ Cochrane drew attention to the need to evaluate the effectiveness of health service intervention. Despite his plea for more evaluative research in health services, it has been suggested that only 20% of health care interventions have been rigorously evaluated. Changes in the structure and philosophy of the NHS in the past decade have stimulated interest in the evaluation of health services interventions at both local and national levels.

Objectives: To explore the extent to which commonly used measures of specific outcomes in dementia are an appropriate proxy for quality of life in dementia. Methods: This was a cross sectional study set in communities in London and Nottingham, comprising 101 people with dementia and their 99 main family caregivers. The main outcome measures were health related quality of life in dementia (measured by the DEMQOL-Proxy), cognition (Mini Mental State Examination), functional impairment (Barthel Index), behavioural and psychological symptoms in dementia (Neuropsychiatric Inventory; NPI), and carer mental health (General Health Questionnaire). Results: On univariate analysis, decreased quality of life was statistically significantly correlated with higher levels of behavioural and psychological disturbance (NPI total score and its agitation, depression, anxiety, disinhibition, and irritability subscales); younger age of the person with dementia; and poorer mental health of the carer. Quality of life was not statistically significantly associated with cognition or carer age. In a multivariate model, psychological and behavioural disturbance and patient age remained statistically significantly associated with quality of life. Carer mental health was no longer statistically significantly associated, and cognition and functional limitation remained statistically insignificant. Conclusions: These data suggest that quality of life in dementia is complex, and that simple proxy substitutions of discrete measures such as cognition or function are likely to miss important factors.

An important and often neglected aspect in the evaluation of patient outcomes in venous disease is quality of life. This paper addresses the why, what, and how of measuring health-related quality of life (HRQL) in venous disease by providing an overview of practical and scientific considerations in developing and using measures of HRQL in general. It begins with a brief overview of developments in the field of measuring HRQL and the definition of HRQL. This is followed by a consideration of issues relevant to the assessment of HRQL including generic and disease-specific measures, multiple compo nents of HRQL, different methods of measurement, measuring change, and cultural appropriateness of HRQL measures. In the next section, criteria for evaluating the scien tific credibility and practical utility of HRQL measures are outlined, followed by a descrip tion of some widely used generic and disease-specific measures of HRQL, including measures of HRQL in chronic venous disorders of the leg (CVDL).

BackgroundDementia 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.ObjectivesThe 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.Data sourcesIn 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.Review methodsThis 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.ResultsAll 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.LimitationsThe 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.ConclusionThe 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.FundingThe National Institute for Health Research Health Technology Assessment programme.

The Quebec Back Pain Disability Scale is a new measure of functional disability for patients with back pain. Functional disability was operationalized in terms of perceived difficulty associated with simple physical activities. The content of the scale was developed in several stages, including a literature review, two studies seeking the opinions of patients and experts, pilot testing, and a large, longitudinal study of back pain patients. Forty-eight disability items were extensively studied using standard methods such as test-retest reliability, item-total correlations, and factor analysis, as well as modern techniques based on item response theory. Items that were highly effective in discriminating between different levels of disability were selected for the final, reduced scale. The scale has 20 items, representing six empirically derived categories of activities affected by back pain. Measurement properties of this instrument have been previously discussed.

This paper describes strategies for measuring outcomes to evaluate interventions to improve health-related quality of life (HRQL) in HIV infection and presents data comparing different methods of measuring HRQL from an ongoing randomized, controlled trial. Conceptual and methodological contributions from the literature on the assessment of health status and quality of life are reviewed, followed by a summary of empirical work on measurement of HRQL in HIV infection and description of the outcome measurement strategy adopted in this study. Preliminary data from the baseline phase of a randomized, controlled trial of an intervention to improve quality of life in 81 persons with HIV infection are analyzed to address issues related to the measurement of outcomes. Three types of measures were used including: i) outcome measures of quality of life (SF-36, QL-Index. HIVIS. patient utilities), psychological well-being (POMS, CES-D, Impact of Event Scale), clinical status (symptoms, T4 cell counts, percei...

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. 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. Results: 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. Conclusion: 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. Copyright © 2012, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc.

BACKGROUND: Surgical site infections (SSIs) are complications of surgery that cause significant postoperative morbidity. SSI has been proposed as a potential indicator of the quality of care in the context of clinical governance and monitoring of the performance of NHS organisations against targets. OBJECTIVES: We aimed to address a number of objectives. Firstly, identify risk factors for SSI, criteria for stratifying surgical procedures and evidence about the importance of postdischarge surveillance (PDS). Secondly, test the importance of risk factors for SSI in surveillance databases and investigate interactions between risk factors. Thirdly, investigate and validate different definitions of SSI. Lastly, develop models for making risk-adjusted comparisons between hospitals. DATA SOURCES: A single hospital surveillance database was used to address objectives 2 and 3 and the UK Surgical Site Infection Surveillance Service database to address objective 4. STUDY DESIGN: There were four elements to the research: (1) systematic reviews of risk factors for SSI (two reviewers assessed titles and abstracts of studies identified by the search strategy and the quality of studies was assessed using the Newcastle Ottawa Scale); (2) assessment of agreement between four SSI definitions; (3) validation of definitions of SSI, quantifying their ability to predict clinical outcomes; and (4) development of operation-specific risk models for SSI, with hospitals fitted as random effects. RESULTS: Reviews of SSI risk factors other than established SSI risk indices identified other risk; some were operation specific, but others applied to multiple operations. The factor most commonly identified was duration of preoperative hospital stay. The review of PDS for SSI confirmed the need for PDS if SSIs are to be compared meaningfully over time within an institution. There was wide variation in SSI rate (SSI%) using different definitions. Over twice as many wounds were classified as infected by one definition only as were classified as infected by both. Different SSI definitions also classified different wounds as being infected. The two most established SSI definitions had broadly similar ability to predict the chosen clinical outcomes. This finding is paradoxical given the poor agreement between definitions. Elements of each definition not common to both may be important in predicting clinical outcomes or outcomes may depend on only a subset of elements which are common to both. Risk factors fitted in multivariable models and their effects, including age and gender, varied by surgical procedure. Operative duration was an important risk factor for all operations, except for hip replacement. Wound class was included least often because some wound classes were not applicable to all operations or were combined because of small numbers. The American Association of Anesthesiologists class was a consistent risk factor for most operations. CONCLUSIONS: The research literature does not allow surgery-specific or generic risk factors to be defined. SSI definitions varied between surveillance programmes and potentially between hospitals. Different definitions do not have good agreement, but the definitions have similar ability to predict outcomes influenced by SSI. Associations between components of the National Nosocomial Infections Surveillance risk index and odds of SSI varied for different surgical procedures. There was no evidence for effect modification by hospital. Estimates of SSI% should be disseminated within institutions to inform infection control. Estimates of SSI% across institutions or countries should be interpreted cautiously and should not be assumed to reflect quality of medical care. Future research should focus on developing an SSI definition that has satisfactory psychometric properties, that can be applied in everyday clinical settings, includes PDS and is formulated to detect SSIs that are important to patients or health services. FUNDING: The National Institute for Health Research Technology Assessment programme.

We undertook a systematic review of disease-specific measures of health-related quality of life (HRQL) in diabetic peripheral neuropathy (DPN) to appraise the scientific (psychometric) evidence and make recommendations about the best instrument(s) to use. DPN is a common complication of diabetes mellitus. A need to consider the broad impact of DPN, rather than just pain and the increasingly recognised need to assess patient-reported outcomes such as HRQL in evaluating healthcare has led to a demand for rigorous outcome measures. To identify appropriate disease-specific measures, we searched four databases: PubMed, Embase, PsycINFO and CINAHL Plus. Data were extracted from each article using a standard data extraction form and the psychometric properties of each HRQL measure were reviewed. We identified three DPN-specific measures of HRQL: PN-QOL-97, Norfolk QOL-DN, NeuroQoL. All three measures satisfy at least one criterion for both reliability and validity, though all also have some disadvantages. Where there is no requirement for multi-language versions, the PN-QOL-97 is a useful instrument. Studies that involve multiple languages would need to use the shorter QOL-DN but would also need to incorporate complementary instruments to address the psychological and emotional impact of DPN.

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.

Dependent measures used to assess anxiety and cooperation in children during a routine visit to the dentist included heart rate, the State–Trait Anxiety Inventory for Children (STAIC; Spielberger 1973), the Melamed Behavior Profile Rating Scale (MBPRS; Melamed, Weinstein, Hawes, & Katin-Borland, 1975), the Fear Thermometer (Cuthbert & Melamed, 1982) and the Frankl Scale (Frankl, Shiere, & Fogels, 1962). Results of univariate analyses of variance on these measures showed that in the “mother present” condition child monitors were more disruptive than child blunters on the MBPRS. A main effect of mothers' presence was also found. Children in the “mother present” condition were found to be less disruptive than children in the “mother absent” condition on the MBPRS. Results from this study suggest that mothers' presence appears to have a small beneficial influence on some children's anxiety and cooperative behavior in the dental operatory.

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. 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. Design and subjects: 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. Measures: SAQOL-39, National Institutes of Health Stroke Scale, Barthel, Frenchay Aphasia Screening Test, General Health Questionnaire-12 and Frenchay Activities Index. Results: 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 (α = 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. Conclusions: 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.

Objective 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. Design Cost-utility analysis based on a Markov model. Setting National Health Service (NHS) Trusts in England and Wales. Population Women for whom surgical treatment for uterine fibroids is being considered. Methods 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. Main outcome measures Incremental cost-effectiveness measured by cost per quality-adjusted life-year (QALY) gained. Results 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. Conclusions A treatment strategy for symptomatic uterine fibroids starting with MRgFUS is likely to be cost-effective. Please cite this paper as: Zowall H, Cairns J, Brewer C, Lamping D, Gedroyc W, Regan L. Cost-effectiveness of magnetic resonance-guided focused ultrasound surgery for treatment of uterine fibroids. BJOG 2008;115:653–662.

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

Background. 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.Method. 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).Results. 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.Conclusions. 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.

To develop a new patient-based outcome measure in plastic surgery for head/neck skin lesions for use in audit, clinical trials and effectiveness studies.Questionnaire development and validation study. Qualitative methods, including interviews with 27 patients, were carried out to develop a preliminary version of the questionnaire. The questionnaire was then field tested by postal survey of 141 pre- and 250 post-surgery patients to produce a shortened (item-reduced) questionnaire and to evaluate acceptability, reliability, validity and responsiveness. A second field test was carried out by postal survey in an independent sample of 67 pre-surgery patients to further evaluate the reliability and validity of the questionnaire.Psychometric properties of acceptability, reliability, validity, and responsiveness were assessed.We developed a new measure, the Patient Outcomes of Surgery-Head/Neck (POS-Head/Neck), which includes a six- and nine-item pre- and post-surgery questionnaire, respectively. Results confirmed the acceptability (missing data10%, evenly distributed endorsement frequencies), reliability (Cronbach alphas0.76, item-total correlations0.22), validity (scale inter-correlations r=0.50, scaling assumptions, correlations with age and sex-0.25) and responsiveness (effect size=0.63) of the questionnaire.The POS-Head/Neck is a new surgical outcome measure that can be used to evaluate outcomes in malignant and benign head/neck skin lesions before and after surgery is acceptable to patients and satisfies rigorous scientific criteria.

Objectives: To compare the responsiveness of the Multiple Sclerosis Impact Scale (MSIS-29) with other self report scales in three multiple sclerosis (MS) samples using a range of methods. To estimate the impact on clinical trials of differing scale responsiveness. Methods: We studied three discrete MS samples: consecutive admissions for rehabilitation; consecutive admissions for steroid treatment of relapses; and a cohort with primary progressive MS (PPMS). All patients completed four scales at two time points: MSIS-29; Short Form 36 (SF-36); Functional Assessment of MS (FAMS); and General Health Questionnaire (GHQ-12). We determined: (1) the responsiveness of each scale in each sample (effect sizes): (2) the relative responsiveness of competing scales within each sample (relative efficiency): (3) the differential responsiveness of competing scales across the three samples (relative precision); and (4) the implications for clinical trials (samples size estimates scales to produce the same effect size). Results: We studied 245 people (64 rehabilitation; 77 steroids; 104 PPMS). The most responsive physical and psychological scales in both rehabilitation and steroids samples were the MSIS-29 physical scale and the GHQ-12. However, the relative ability of different scales to detect change in the two samples was variable. Differing responsiveness implied more than a twofold impact on sample size estimates. Conclusions: The MSIS-29 was the most responsive physical and second most responsive psychological scale. Scale responsiveness differs notably within and across samples, which affects sample size calculations. Results of clinical trials are scale dependent.