17 research outputs found

    An item response theory analysis of an item pool for the recovering quality of life (ReQoL) measure

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    Purpose ReQoL-10 and ReQoL-20 have been developed for use as outcome measures with individuals aged 16 and over, experiencing mental health difficulties. This paper reports modelling results from the item response theory (IRT) analyses that were used for item reduction. Methods From several stages of preparatory work including focus groups and a previous psychometric survey, a pool of items was developed. After confirming that the ReQoL item pool was sufficiently unidimensional for scoring, IRT model parameters were estimated using Samejima’s Graded Response Model (GRM). All 39 mental health items were evaluated with respect to item fit and differential item function regarding age, gender, ethnicity, and diagnosis. Scales were evaluated regarding overall measurement precision and known-groups validity (by care setting type and self-rating of overall mental health). Results The study recruited 4266 participants with a wide range of mental health diagnoses from multiple settings. The IRT parameters demonstrated excellent coverage of the latent construct with the centres of item information functions ranging from − 0.98 to 0.21 and with discrimination slope parameters from 1.4 to 3.6. We identified only two poorly fitting items and no evidence of differential item functioning of concern. Scales showed excellent measurement precision and known-groups validity. Conclusion The results from the IRT analyses confirm the robust structure properties and internal construct validity of the ReQoL instruments. The strong psychometric evidence generated guided item selection for the final versions of the ReQoL measures

    Lifestyle Matters for maintenance of health and wellbeing in people aged 65 years and over: study protocol for a randomised controlled trial

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    Background Healthy, active ageing is strongly associated with good mental wellbeing which in turn helps to prevent mental illness. However, more investment has been made into research into interventions to prevent mental illness than into those designed to improve mental wellbeing. This applied research programme will provide high quality evidence for an intervention designed to improve and sustain mental wellbeing in older adults. Methods/Design This study was a multi-centre, pragmatic, two-arm, parallel group, individually randomised controlled trial to determine the population benefit of an occupational therapy based intervention for community living people aged 65 years or older. Participants (n = 268) will be identified in one city in the North of England and in North Wales through GP mail-outs, signposting by local authority, primary care staff and voluntary sector organisations and through community engagement. Participants will be randomised to one of two treatment arms: an intervention (Lifestyle Matters programme); or control (routine access to health and social care). All participants will be assessed at baseline, 6 and 24 months post-randomisation. The primary outcome, which is a person reported outcome, is the SF-36 Mental Health dimension at six months post randomisation. Secondary outcome measures have been selected to measure psychosocial, physical and mental health outcomes. They include other dimensions of the SF36, EQ-5D-3L, Brief Resilience Scale, General Perceived Self Efficacy Scale, PHQ-9, de Jong Gierveld Loneliness Scale, Health and Social Care Resource Use and the wellbeing question of the Integrated Household Survey 2011. A cost effectiveness analysis will investigate the incremental cost per Quality Adjusted Life Years (QALYs) of the Lifestyle Matters intervention compared with treatment as usual. Discussion The questions being posed through this research are important given the increasing numbers of older people, pressure on the public purse and the associated need to support good health in the extended lifespan. The proposed trial will determine the clinical and cost effectiveness of the intervention delivered in a UK context. The results will support commissioners and providers with decisions about implementation.</p

    Recovering Quality of Life (ReQoL): a new generic self-reported outcome measure for use with people experiencing mental health difficulties†

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    Outcome measures for mental health services need to adopt a service-user recovery focus. To develop and validate a 10- and 20-item self-report recovery-focused quality of life outcome measure named Recovering Quality of Life (ReQoL). Qualitative methods for item development and initial testing, and quantitative methods for item reduction and scale construction were used. Data from >6500 service users were factor analysed and item response theory models employed to inform item selection. The measures were tested for reliability, validity and responsiveness. ReQoL-10 and ReQoL-20 contain positively and negatively worded items covering seven themes: activity, hope, belonging and relationships, self-perception, well-being, autonomy, and physical health. Both versions achieved acceptable internal consistency, test–retest reliability (>0.85), known-group differences, convergence with related measures, and were responsive over time (standardised response mean (SRM) > 0.4). They performed marginally better than the Short Warwick-Edinburgh Mental Well-being Scale and markedly better than the EQ-5D. Both versions are appropriate for measuring service-user recovery-focused quality of life outcomes. M.B. and J.Co. were members of the research group that developed the Clinical Outcomes in Routine Evaluation (CORE) outcome measures

    Exploring the item sets of the Recovering Quality of Life (ReQoL) measures using factor analysis

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    Purpose This paper presents two studies exploring the latent structure of item sets used in the development of the Recovering Quality of Life mental health outcome measures: ReQoL-10 and ReQoL-20. Method In study 1, 2262 participants completed an initial set of 61 items. In study 2, 4266 participants completed a reduced set of 40 items. Study 2 evaluated two formats of the questionnaires: one version where the items were intermingled and one where the positively worded and negatively worded items were presented as two separate blocks. Exploratory and confirmatory factor analyses were conducted on both datasets where models were specified using ordinal treatment of the item responses. Dimensionality based on the conceptual framework and methods effects reflecting the mixture of positively worded and negatively worded items were explored. Factor invariance was tested across the intermingled and block formats. Results In both studies, a bi-factor model (study 1: RMSEA = 0.061; CFI = 0.954; study 2: RMSEA = 0.066; CFI = 0.971) with one general factor and two local factors (positively worded questions and negatively worded questions) was preferred. The loadings on the general factor were higher than on the two local factors suggesting that the ReQoL scale scores can be understood in terms of a general factor. Insignificant differences were found between the intermingled and block formats. Conclusions The analyses confirmed that the ReQoL item sets are sufficiently unidimensional to proceed to item response theory analysis. The model was robust across different ordering of positive and negative items

    Which outcomes are most important to measure in patients with COVID-19 and how and when should these be measured? Development of an international standard set of outcomes measures for clinical use in patients with COVID-19: a report of the International Consortium for Health Outcomes Measurement (ICHOM) COVID-19 Working Group.

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    Objectives: The COVID-19 pandemic has resulted in widespread morbidity and mortality with the consequences expected to be felt for many years. Significant variation exists in the care even of similar patients with COVID-19, including treatment practices within and between institutions. Outcome measures vary among clinical trials on the same therapies. Understanding which therapies are of most value is not possible unless consensus can be reached on which outcomes are most important to measure. Furthermore, consensus on the most important outcomes may enable patients to monitor and track their care, and may help providers to improve the care they offer through quality improvement. To develop a standardised minimum set of outcomes for clinical care, the International Consortium for Health Outcomes Measurement (ICHOM) assembled a working group (WG) of 28 volunteers, including health professionals, patients and patient representatives. Design: A list of outcomes important to patients and professionals was generated from a systematic review of the published literature using the MEDLINE database, from review of outcomes being measured in ongoing clinical trials, from a survey distributed to patients and patient networks, and from previously published ICHOM standard sets in other disease areas. Using an online-modified Delphi process, the WG selected outcomes of greatest importance. Results: The outcomes considered by the WG to be most important were selected and categorised into five domains: (1) functional status and quality of life, (2) mental functioning, (3) social functioning, (4) clinical outcomes and (5) symptoms. The WG identified demographic and clinical variables for use as case-mix risk adjusters. These included baseline demographics, clinical factors and treatment-related factors. Conclusion: Implementation of these consensus recommendations could help institutions to monitor, compare and improve the quality and delivery of care to patients with COVID-19. Their consistent definition and collection could also broaden the implementation of more patient-centric clinical outcomes research.</p

    Behaviour change intervention for toothbrushing (lesson and text messages) to prevent dental caries in secondary school pupils: The BRIGHT randomized control trial

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    Objectives: This multicentre, assessor‐blinded, two‐arm cluster randomized trial evaluated the clinical and cost‐effectiveness of a behaviour change intervention promoting toothbrushing for preventing dental caries in UK secondary schools. Methods: Pupils aged 11–13 years with their own mobile telephone attending secondary schools with above average free school meals eligibility were randomized (at year‐group level) to receive a lesson and twice‐daily text messages or to usual care. Year‐groups (n = 84) from 42 schools including 4680 pupils (intervention, n = 2262; control, n = 2418) were randomized. Results: In 2383 participants with valid data at baseline and 2.5 years, the primary outcome of presence of at least one treated or untreated carious lesion (D4‐6 MFT [Decayed, Missing and Filled Teeth] in permanent teeth using International Caries Detection and Assessment System) was 44.6% in the intervention group and 43.0% in control (odds ratio [OR] 1.04, 95% CI 0.85–1.26, p = .72). There were no statistically significant differences in secondary outcomes of presence of at least one treated or untreated carious lesion (D1‐6 MFT), number of D4‐6 MFT and D1‐6 MFT, plaque and bleeding scores or health‐related‐ (Child Health Utility 9D) or oral health‐related‐ quality of life (CARIES‐QC). However, twice‐daily toothbrushing, reported by 77.6% of pupils at baseline, increased at 6 months (intervention, 86.9%; control, 83.0%; OR 1.30, 95% CI 1.03–1.63, p = .03), but returned to no difference at 2.5 years (intervention, 81.0%; control, 79.9%; OR 1.05, 95% CI 0.84–1.30, p = .69). Estimated incremental costs and quality‐adjusted life‐years (QALYs) of the intervention, relative to control, were £1.02 (95% CI −1.29 to 3.23) and −0.003 (95% CI −0.009 to 0.002), respectively, with a 7% chance of being cost‐effective (£20 000/QALY gained threshold). Conclusion: There was no evidence of statistically significant difference for caries prevalence at 2.5‐years. The intervention's positive 6‐month toothbrushing behaviour change did not translate into caries reduction. (ISRCTN 12139369). COVID‐19 pandemic adversly affected follow‐up

    Proceedings of Patient Reported Outcome Measure’s (PROMs) Conference Oxford 2017: Advances in Patient Reported Outcomes Research

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    A33-Effects of Out-of-Pocket (OOP) Payments and Financial Distress on Quality of Life (QoL) of People with Parkinson’s (PwP) and their Carer

    Validation of ‘Care Of the Dying Evaluation’ (CODETM) within an international study exploring bereaved relatives’ perceptions about quality of care in the last days of life

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    Context: Assessing quality of care provided during the dying phase using validated tools aids quality assurance and recognizes unmet need. Objective: To assess construct validity and internal consistency of ‘Care Of the Dying Evaluation’ (CODETM) within an international context. Methods: Post-bereavement survey (August 2017 to September 2018) using CODETM. Respondents were next-of-kin to adult patients (≥ 18 years old) with cancer who had an ‘expected’ death within 22 study site hospitals in 7 countries: Argentina, Brazil, Germany, Norway, Poland, United Kingdom, Uruguay. Exploratory and Confirmatory Factor Analysis (EFA and CFA) were conducted, and internal reliability was assessed using Cronbach alpha (α). Known group validity was assessed by ability to discriminate quality of care based in place (Palliative Care Units (PCUs)) and country (Poland, where most deaths were in PCUs) of care. Differences were quantified using effect sizes (ES). Results: A 914 CODETM questionnaires completed (54% response rate). 527 (58%) male deceased patients; 610 (67%) next-of-kin female who were most commonly the ‘spouse/partner’ (411, 45%). EFA identified 4 factors: ‘Overall care,’ ‘Communication and support,’ ‘Trust, respect and dignity,’ and ‘Symptom management’ with good reliability scores (α = 0.628 – 0.862). CFA confirmed the 4-factor model; these were highly correlated and a bifactor model showed acceptable fit. The ES for quality of care in PCU's was 0.727; ES for Poland was 0.657, supporting the sensitivity of CODETM to detect differences. Conclusion: Within an international context, good evidence supports the validity and reliability of CODETM for assessing the quality of care provided in the last days of life

    Additional file 1 of Assessing the psychometric performance of EQ-5D-5L in dementia: a systematic review

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    Additional file 1. Table S1: Known-group validity (7 studies). Table S2: Convergent validity (9 studies). Table S3: Reliability (7 studies). Table S4 Quality assessment of included papers adapted from the GRADE assessment tool
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