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Objective: To determine if quality of life (QoL) changes before, during and after menopause and whether these changes are linked to symptoms, demographics, and/or lifestyle factors., Methods: We undertook a cross-sectional online survey. We invited women aged between 35 and 60 years to complete the survey which included the Short-Form 36 (SF-36) generic quality of life measure, the menopause specific Utian-Quality of life (UQOL) measure, and questions about health and wellbeing, menopause symptoms and hormonal stage. The data were analysed with one-way ANOVA analysis and multivariate regression modelling., Results: 279 women completed the survey. Most were aged between 51 and 55 years. In the unadjusted analysis there was a tendency for QoL to deteriorate from pre to peri to menopause and then increase slightly post menopause. This was however not significant in multivariate analysis. Multivariate analysis identified that lifestyle factors significantly influenced QoL. Regular exercise resulted in better QoL scores across a number of the UQol and SF-36 sub-scales. Being very overweight and having more menopause symptoms resulted in worse QoL., Conclusions: Although there was a trend towards worse quality of life in the peri and menopause stages this was not significantly different in adjusted multivariate analyses. Those experiencing more symptoms had significantly worse QoL. Lifestyle factors may affect QoL, but the picture is not straightforward. It is promising that there was a trend toward improved QoL in the post-menopausal stage. These findings should inform education material and promote awareness of the menopause and its impact on QoL. (245)., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)

Facial skin cancer is common, and its treatment affects patient's health-related quality of life (HRQoL), as demonstrated by patient-reported outcome measures (PROMs). In this study, we anglicise and validate the novel FACE-Q Skin Cancer Module for the UK population. Anglicisation of the FACE-Q Skin Cancer Module followed international guidance for cross-cultural adaptation. Cognitive interviews were performed, producing a reconciled and harmonised version for validation. Patients undergoing facial skin cancer excision were prospectively recruited and asked to complete the anglicised FACE-Q Skin Cancer Module, along with the Skin Cancer Index (SCI) and European Quality of Life-Five Dimensions (ED-5D) questionnaire, pre-operatively and 6-8 weeks post-operatively. Data were analysed using classical test theory. Ethical approval was obtained (REC: 16/WM/0445). One hundred and ten patients were recruited between August 2017 and July 2018. Internal consistency was high (Cronbach's alpha 0.867-0.967). All subscales had a single-factor solution using principal component analysis. Construct validity, as measured between the FACE-Q subscales and SCI subscales, was good, with >75% of a priori predictions confirmed. Pearson's r for item-total correlation was >0.80 for several items, and significant ceiling effects are shown in 7 of the 10 subscales, suggesting some item redundancy. The UK version of this well-designed PROM demonstrates good face and construct validity. There is however a degree of redundancy within the scales, and further work using Rasch analysis on a larger sample will help address this., (Copyright © 2020 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)

Background: A nested qualitative interview study within the CONSTRUCT trial was conducted to explore experiences and perceptions of patients with acute severe ulcerative colitis following treatment with infliximab or ciclosporin, surgery, or other medication., Methods: Two hundred seventy patients with steroid-resistant ulcerative colitis were randomised to either infliximab or ciclosporin. Interviews were conducted with 20 trial participants. Thirty-five data capture events took place in total, 20 interviews conducted 3 months after treatment and a further 15 interviews with the same cohort as second interviews at 12 months., Results: Disease duration varied but similar stories emerged about how people adjusted to living with ulcerative colitis. Issues raised by patients included; the debilitating effect of the disease on quality of life, living with the unpredictability of symptoms and treatment, dealing with embarrassment and stigma and the desire to share knowledge of the disease with others to combat the private nature of this debilitating illness and bring greater visibility to patient experience of symptoms and outcomes., Conclusion: Patients were more positive about treatment with infliximab than ciclosporin, mainly due to the cumbersome intravenous regimen required for ciclosporin. Prompt diagnosis is required and early reporting of changes in symptoms is encouraged to ensure appropriate treatment., Trial Registration: This trial is registered with the ISRCTN registry; number ISRCTN22663589 . The date of registration was 16/05/2008.

Objectives: To develop and undertake initial validation of a patient-reported outcome measure to assess health-related quality of life in patients with breast cancer-related upper limb lymphedema (ULL)., Study Design and Setting: We developed and validated the Upper Limb Lymphedema Quality of Life (ULLQoL) scale in two stages: devising the items and pretesting with patients and clinicians; longitudinal validation to test its psychometric properties-underlying dimensions, internal consistency, test-retest reliability, construct validity, and responsiveness. Patients with ULL were recruited from two outpatient clinics., Results: We derived the ULLQoL scale from a pool of 98 items generated by patients. After further consultation, we produced the draft ULLQoL scale. For validation, 103 patients with ULL completed the draft scale and two generic health measures: SF-36 and ED-5D-3L. Psychometric analysis identified two components, physical and emotional well-being, with good internal consistency and test-retest reliability. Significant correlations with SF-36, EQ-5D-3L, and percentage excess limb volume confirmed construct validity. The ULLQoL scale showed good responsiveness to change reported by lymphedema patients and moderate to large effect sizes., Conclusion: The 14-item ULLQoL scale is a robust ULL-specific measure that is feasible and valid to use in both the clinical and research settings., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Introduction: In the UK, it is estimated that a disabling hearing loss (HL) affects 1 in 6 people. HL has functional, economic and social-emotional consequences for affected individuals. Intervention for HL focuses on improving access to the auditory signal using hearing aids or cochlear implants. However, even if sounds are audible and speech is understood, individuals with HL often report increased effort when listening.Listening effort (LE) may be measured using self-reported measures such as patient-reported outcome measures (PROMs). PROMs are validated questionnaires completed by patients to measure their perceptions of their own functional status and well-being. When selecting a PROM for use in research or clinical practice, it is necessary to appraise the evidence of a PROM's acceptability to patients, validity, responsiveness and reliability., Methods and Analysis: A systematic review of studies evaluating the measurement properties of PROMs available to measure LE in HL will be undertaken. MEDLINE, EMBASE, CINAHL, PsychINFO and Web of Science will be searched electronically. Reference lists of included studies, key journals and the grey literature will be hand-searched to identify further studies for inclusion. Two reviewers will independently complete title, abstract and full-text screening to determine study eligibility. Data on the characteristics of each study and each PROM will be extracted. Methodological quality of the included studies will be appraised using the COnsensus-based Standards for the selection of health Measurement INstruments, the quality of included PROMs appraised and the credibility of the evidence assessed. A narrative synthesis will summarise extracted data., Ethics and Dissemination: Ethical permission is not required, as this study uses data from published research. Dissemination will be through publication in peer-reviewed journals, conference presentations and the lead author's doctoral dissertation. Findings may inform the selection of PROMs used to measure LE in HL., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background: Although it is now widely endorsed that children should as far as possible rate their own health related quality of life (HRQL), there are situations where proxy information on child HRQL may be useful, especially where a child is too ill or young to provide their own HRQL assessment. There is limited availability of generic HRQL scales that have a parallel child and parent version and that are reliable, valid, brief, comprehensible and suitable for use in UK populations. The aims of this study were therefore to develop and validate a parent version of the anglicised Manchester-Minneapolis Quality of Life child form (MMQL-UK (CF)) and to determine the level of association between the child and parent versions of this form., Methods: This study was undertaken concurrently with the anglicisation and validation of the MMQL, a measure of HRQL developed for use with children in North America. At that time, no parent version existed, so the MMQL form for children (MMQL-UK (CF)) was used as the basis for the development of the MMQL-UK parent form (PF). The sample included a control group of healthy children and their parents and five exemplar groups; children diagnosed with asthma, diabetes or inflammatory bowel disease and their parents, children in remission from cancer and their parents and children in public care and their carers. Consistency of the MMQL-UK (PF) components were assessed by calculating Cronbach's alpha. Validation of the parent questionnaire was undertaken by comparing MMQL-UK (PF) component scores with comparable components on the proxy PedsQLtrade mark quality of life scales, comparing MMQL-UK (PF) component scores between parents of healthy and chronic disease children and by comparison of component scores from children and their parents or carers. Reproducibility and responsiveness were assessed by retesting parents by follow-up questionnaires., Results: A total of 874 children (completing MMQL-UK (CF)) and 572 parents or carers (completing MMQL-UK (PF)) took part in the study. The internal consistency of all the MMQL-UK (PF) components exceeding the accepted criterion of 0.70 and the construct validity was good with moderate correlations being evident between comparable components of the MMQL-UK (PF) and the proxy PedsQLtrade mark. Discriminant validity was demonstrated with significant differences being identified between parents of healthy children and those with chronic conditions. Intra-class correlations exceeded 0.65 for all MMQL-UK (PF) components demonstrating good reproducibility. Weak to moderate levels of responsiveness were demonstrated for all but social functioning. The MMQL-UK (PF) showed moderate parent-child correlation with the MMQL-UK (CF) for all components. The best correlations were seen for those components measuring the same construct (Pearson's r ranged from 0.31 to 0.61, p < 0.01 for equivalent components)., Conclusion: The MMQL-UK (PF) showed moderate to good correlations with the MMQL-UK (CF) component scores. The MMQL-UK (PF) will be of use when comparing child and parent/carer perception of the impact of a child's condition on their HRQL or where the child is too ill or young to provide their own report.

Background: Health related quality of life (HRQL) has been recognised as an important paediatric outcome measurement. One of the more promising measures to emerge in recent years is the Pediatric Quality Of Life Inventory (PedsQL), developed in the US. Advantages of the PedsQL include brevity, availability of age appropriate versions and parallel forms for child and parent. This study developed a UK-English version of PedsQL generic module and assessed its performance in a group of UK children and their parents., Methods: PedsQL was translated to UK-English. The psychometric properties of the UK version were then tested following administration to 1399 children and 970 of their parents. The sample included healthy children, children diagnosed with asthma, diabetes or inflammatory bowel disease and children in remission from cancer., Results: Psychometric properties were similar to those reported for the original PedsQL. Internal reliability exceeded 0.70 for all proxy and self-report sub-scales. Discriminant validity was established for proxy and self-report with higher HRQL being reported for healthy children than those with health problems. Sex differences were noted on the emotional functioning subscale, with females reporting lower HRQL than males. Proxy and self-report correlation was higher for children with health problems than for healthy children., Conclusion: The UK-English version of PedsQL performed as well as the original PedsQL and is recommended for assessment of paediatric HRQL in the UK.

Background: there is currently limited research examining the QoL of patients with Ulcerative colitis (UC) following treatment of acute severe colitis (ASUC). Objective: to examine the long-term QoL of ASUC patients enrolled in the CONSTRUCT trial following treatment of UC with infliximab or ciclosporin and to compare the differences in the QoL between the two drug treatments over time. Methods: The CONSTRUCT trial examined the cost and clinical effectiveness of infliximab and ciclosporin treatments for acute severe UC. We collected QoL questionnaire data from patients during the active trial period up to 36 months. Following trial completion, we contacted patients postannually for up to a maximum of 84 months. We collected QoL data using a disease-specific (CUCQ, or CUCQ+ for patients who had colectomy surgery) or generic (EQ5D-3L) questionnaire. We analysed QoL scores to determine if there was any difference over time and between treatments in generic or disease-specific QoL. Results: Following initial treatment with infliximab and ciclosporin, patients experienced a statistically significant improvement in both the generic and disease-specific QoL at three months. Generic scores remained fairly static for the whole follow-up period, reducing only slightly up to 84 months. Disease-specific scores showed a much sharper improvement up to 2 years with a gradual reduction in QoL up to 84 months. Generic and disease-specific QoL remained higher than baseline values. There was no significant difference between treatments in any of the QoL scores. Conclusions: Both infliximab and ciclosporin improve QoL following initial treatment for ASUC. QoL scores remain higher than at admission up to 84 months post-treatment. [ABSTRACT FROM AUTHOR]

Background: Crohn's and Ulcerative Colitis Questionnaire-32 (CUCQ-32) is a validated questionnaire to measure the quality of life (QoL) in Inflammatory Bowel Disease (IBD). However, it does not have stoma-specific questions and can be lengthy. This study aimed to validate a subset of the CUCQ-32 that would be suitable for patients with a stoma. Methods: Baseline data were collected from a cohort of patients with acute ulcerative colitis who were participating in the CONSTRUCT multicentre clinical trial. A subset of the CUCQ-32 questions was selected by stepwise regression. Further validation was examined using data from the UK IBD biological therapies audit. Construct validity was carried out using the EuroQol 5 dimensions (EQ5D) questionnaire, Simple Clinical Colitis Activity Index (SCCAI), and the Harvey–Bradshaw Index (HBI). Results: Using the data from 124 patients, a short-version questionnaire (CUCQ-12) was developed. Data from 484 patients with IBD (382 patients with Crohn's disease, 76 patients with ulcerative colitis, and 26 patients with IBD-Unclassified) and 61 patients with stoma provided further validation of the CUCQ-12. A literature review and an expert focus group identified supplementary stoma-specific questions for the CUCQ-12+. The CUCQ-12+ demonstrated excellent internal consistency (Cronbach's α = 0.86); established effective reproducibility (intra-class correlation coefficient = 0.74); correlated well with the EQ5D (r= −0.48), HBI (r = 0.45), and SCCAI (r = 0.43); and represented good responsiveness statistics (>0.5). Conclusions: CUCQ-12+ is a valid and reliable QoL measure used for all patients with IBD in clinical practice, including patients with a stoma. [ABSTRACT FROM AUTHOR]

Summary: Background: Current guidelines in primary biliary cholangitis (PBC) recommend routine screening for symptoms. However, at present there are no validated practical tools suitable for screening use in practice. Aim: To develop a short quality of life questionnaire for PBC Methods: The short PBC HRQL questionnaire was derived and validated by analysing the PBC‐40 questionnaires from the UK‐PBC Research Cohort. Construct validity was assessed using the European Quality of Life Five Dimensions (EQ5D) questionnaire. Test‐retest analysis was done by asking a subgroup of patients to complete the questionnaire twice within 2‐4 weeks. Results: A total of 2219 patients completed PBC‐40 questionnaire in 2013. Stepwise regression identified 10 questions that contributed to more than 95% of the PBC‐40 score variance and covered the main domains of PBC. The short HRQL questionnaire, PBC‐10, had good internal consistency (Cronbach's α 0.905) and item‐total correlations. PBC‐10 demonstrated no ceiling effects but a floor effect was noted. Further validation on 2502 patients who completed the PBC questionnaire in 2017 confirmed the psychometric properties of PBC‐10. Further analysis on 186 patients showed that PBC‐10 demonstrated good internal consistency (Cronbach's α = 0.936), had good reproducibility (intra‐class correlation coefficient = 0.945), good correlation with the EQ5D (r = .736), and was responsive to change. A change of 4 points in the PBC‐10 score would be considered clinically important. Conclusion: PBC‐10 is a short and valid questionnaire for assessing the HRQL in patients with PBC in clinical practice. [ABSTRACT FROM AUTHOR]

Aim We evaluated the introduction of a predictive risk stratification model (PRISM) into primary care. Contemporaneously National Health Service (NHS) Wales introduced Quality and Outcomes Framework payments to general practices to focus care on those at highest risk of emergency admission to hospital. The aim of this study was to evaluate the costs and effects of introducing PRISM into primary care. Methods Randomised stepped wedge trial with 32 general practices in one Welsh health board. The intervention comprised: PRISM software; practice-based training; clinical support through two 'general practitioner (GP) champions' and technical support. The primary outcome was emergency hospital admissions. Results Across 230 099 participants, PRISM implementation increased use of health services: emergency hospital admission rates by 1 % when untransformed (while change in log-transformed rate AL=0.011, 95% CI 0.010 to 0.013); emergency department (ED) attendance rates by untransformed 3 % (while Al=0.030, 95% CI 0.028 to 0.032); outpatient visit rates by untransformed 5 % (while AL=0.055, 95% CI 0.051 to 0.058); the proportion of days with recorded GP activity by untransformed 1 % (while AL=0.011, 95% CI 0.007 to 0.014) and time in hospital by untransformed 3 % (while Al=0.029, 95% CI 0.026 to 0.031). Thus NHS costs per participant increased by £76 (95% CI £46 to £106). Conclusions Introduction of PRISM resulted in a statistically significant increase in emergency hospital admissions and use of other NHS services without evidence of benefits to patients or the NHS. [ABSTRACT FROM AUTHOR]

Background and aim: Several measures have been developed to assess the health-related quality of life [HRQoL] of patients with inflammatory bowel disease [IBD]. Our aim is to systematically review the HRQoL measures specific for patients with IBD and to appraise their measurement properties and methodological quality. Methods: We searched the PubMed, Embase, and PsycINFO databases for original articles describing the development and/or evaluation of one or more of the measurement properties [e.g. internal consistency, reliability, validity, responsiveness] of HRQoL measures specific for IBD. We assessed the measurement properties and examined the methodological quality of the measurement properties of each instrument using a standardized checklist. Results: We examined the full text of 75 articles that we deemed potentially eligible and identified 10 disease-specific HRQoL measures in IBD that covered different aspects of patients' lives. Internal consistency, construct validity, and content validity were the commonly evaluated measurement properties. Seven HRQoL measures scored positive for at least four of eight measurement properties. The majority of studies were rated as 'fair' to 'poor' when assessing their methodology quality. The most established HRQoL measure in the literature was the Inflammatory Bowel Disease Questionnaire [IBDQ]. Conclusions: Most of the included HRQoL measures did not include all the required measurement properties or had a problem with their methodological quality. The most widely used and validated measure was the IBDQ. Further validation studies are required to support the use of other HRQoL measures. [ABSTRACT FROM AUTHOR]

In this article we examine whether an innovative mixed method approach could highlight the positive and challenging effects of a Pulmonary Rehabilitation Programme (PRP) on the Quality of Life (QOL) of patients with Chronic Obstructive Pulmonary Disease (COPD). In 2012, we conducted three consultation workshops in Mid-West Wales, UK, with COPD patients that participated in a PRP, their significant others (e.g. spouses and partners), and healthcare professionals who delivered the PRP. We found that there was a resounding enthusiasm for the content and impact of the programme, particularly in the areas of: increased patient activity, enhanced patient control and confidence, a greater willingness to self-manage treatment, and an increased sense of group belonging. Seven key themes mattered most to our study participants: the patient, physical health, mental health, the programme, professionals and significant others, knowledge and education, and the future. We used these themes to craft a best-practice outcomes document (template) of the benefits and challenges of the PRP to inform and support future service evaluation and delivery. [ABSTRACT FROM AUTHOR]

Background and aims: Most of the disease-specific quality of life (QoL) measures for inflammatory bowel disease (IBD) are lengthy and time consuming. None have been established for routine use in clinical practice. We designed this study to develop a short QoL measure in IBD. Methods: A 32-item questionnaire, the Crohn's and ulcerative colitis questionnaire (CUCQ)-32 was developed by reviewing the literature of the previously validated questionnaires and by consultation with patients and experts. Construct validity was carried out using the Short Form 12 and the EuroQol 5 dimensions questionnaires and two disease severity measures (the Simple Clinical Colitis Activity Index and the Harvey-Bradshaw Index). Test-retest analysis was done by asking patients to complete the CUCQ questionnaire twice within a period of two weeks. Results: Data were obtained from 205 patients with IBD who completed the CUCQ-32. Psychometric analysis showed that Cronbach's α was 0.88, item-total correlations were good, and there were no ceiling or flooring effects. Stepwise regression identified eight items that accounted for >95% of the variance in the CUCQ-32. The resulting CUCQ-8 demonstrated good internal consistency (Cronbach's α = 0.84), had good reproducibility (intraclass correlation coefficient = 0.94), was well correlated with the EuroQol 5 dimensions questionnaire (r = 0.58) and the Short Form-12 (r = 0.65 for physical component and r = 0.63 for mental component), and was responsive to change (responsiveness ratio was 0.64, p-value < 0.05). Conclusions: CUCQ-8 is a short questionnaire that has the potential to be an efficient tool for assessing the QoL of all patients with IBD in clinical practice. [ABSTRACT FROM AUTHOR]

LINKED CONTENT This article is linked to Alrubaiy et al and and Gulamhusein and Jackson papers. To view these articles, visit https://doi.org/10.1111/apt.15554 and https://doi.org/10.1111/apt.15588. [ABSTRACT FROM AUTHOR]

Background: The value of qualitative methods within trials is widely recognised, but their full potential is not being realised. There are also issues with the visibility, recognition and reporting of qualitative methods in trials. To identify potential improvements in qualitative research within trials, we need to study trials that have included qualitative methods. We aimed to explore the frequency of reporting qualitative methods in registered trials, the types of trials using qualitative methods and where in the world these trials were conducted.Methods: We included registries if they were searchable using keywords and held summaries of trials rather than listing reports or publications. We searched the included registries from the first available record in 1999 to the end of 2016 for the term 'qualitative'. We included trials only if we could confirm that they used qualitative methods through documented use of qualitative data collection and analysis in the registry summary. We analysed registered trials reporting the use of qualitative methods by: year registered, the country responsible for overseeing governance of the trial and the type of trial intervention (categorised as surgical, medical device, behavioural, drug or other).Results: We included three registries: ClinicalTrials.gov, the International Standard Randomised Controlled Trial Number Registry (ISRCTN) and the World Health Organisation International Clinical Trials Registry Platform (WHO ICTRP). A total of 615,311 trials appear in these three registries from 1999 until the end of 2016. Numbers differed across registries with the WHO ICTRP the largest (366,753 trials), ClinicalTrials.gov the second largest (233,277) and ISRCTN the smallest (15,301). Of these registered trials, we confirmed that 1492 (0.24%) reported using qualitative methods. The ISRCTN contributed the highest percentage of trials reported as using qualitative methods (3.4%); in contrast, ClinicalTrials.gov reported 0.3% and WHO ICTRP reported 0.03%. The number and percentage of trials reported to use qualitative methods increased over time from 0 (0.0%) in 1999 to 285 (0.38%) in 2016. Trials reported as using qualitative methods originated from 52 countries across the world. Most were in Western higher-income countries: 38% in the United Kingdom and 28% in the United States. Most registered trials reported as using qualitative methods evaluated behavioural (39%) or other interventions with many fewer trials evaluating drugs (5%), medical devices (5%) or surgical interventions (4%).Conclusion: The reported use of qualitative methods in registered trials has increased over time and worldwide. They are reportedly more frequent in high-income countries and in trials of behavioural and other interventions. Trialists and other stakeholders need to recognise the benefits of using qualitative methods in surgical, device and drug trials, and trials conducted in poorer countries. Moreover, they should seriously consider using qualitative methods in these trials. [ABSTRACT FROM AUTHOR]