Search

Aim: To develop and explore the validity of a Patient Reported Experience Measure (PREM) for adult inpatient diabetes care., Method: 27 in-depth interviews were conducted to inform the development of the 42-item PREM which was cognitively tested with 10 people. A refined 38-item PREM was piloted with 228 respondents completing a paper (n = 198) or online (n = 30) version. The performance of the PREM was evaluated by exploring (i) uptake/number of responses and (ii) survey validity by investigating whether the PREM data were of adequate quality and delivered useful information., Results: The PREM had low drop-out or missing data rates suggesting it was appropriately constructed. Analysis of item frequencies and variances, and problem score calculations concluded that questions provided sufficient score differentiation., Conclusions: This new PREM allows for experiences of inpatient diabetes care to be measured, understood and reported on to help identify priority areas for improving care quality., (© 2023 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.)

Background: The Endometriosis Health Profiles (EHPs), the EHP-30 and EHP-5, are patient-reported outcome measures that were developed to measure the health-related quality of life (HRQoL) of women living with endometriosis. Prior to their development, a systematic review was undertaken which identified that the HRQoL of women living with endometriosis was poorly understood, with only three medical and one surgical study identified., Objective and Rationale: The 20-year anniversary of the EHP-30 provided a timely opportunity to assess how the tools have been used and explore what the findings tell us about the impact of endometriosis and its associated treatments upon women's QoL. Applying robust systematic review methodology, following PRISMA guidelines, we sought to answer: How many studies have used the EHP and for what purpose?; What are the demographic characteristics and international context of the studies?; What is the methodological nature and quality of the studies?; Which interventions have been assessed and what are the reported EHP outcomes?; and Can the EHP outcomes of these interventions be analysed using a meta-analysis and, if so, what do the results show?, Search Methods: The electronic databases MEDLINE, CINAHL, PsycINFO, PubMed, and Google Scholar were searched from the year the EHP was first published, in 2001 to 26 February 2020 using the search terms 'EHP30', 'EHP5', 'EHP-30', 'EHP-5', 'endometriosis health profile 30', and 'endometriosis health profile 5'. We updated the searches on 9 April 2021. All included studies were quality assessed using the Mixed Methods Appraisal Tool (MMAT)., Outcomes: The review included 139 papers. In clinical intervention studies, the EHPs were deployed most frequently to measure the outcomes of medical (n = 35) and surgical (n = 21) treatment. The EHPs were also used in 13 other intervention studies, 29 non-interventional studies, 32 psychometric/cross cultural validation studies; six diagnostic studies, and in three other studies to measure outcomes in related conditions. They were mainly deployed in studies undertaken in Europe and North America. Overall, regardless of the nature of the intervention, most women reported improvements in HRQoL after treatment. Surgical interventions generally resulted in significant improvements for the longest amount of time. There was also evidence that when participants stopped taking medication their EHP scores worsened, perhaps reinforcing the temporary impact of medical treatment. Younger patients reported more negative impact upon their HRQoL. Further evidence using classical test theory to support the EHPs' robust psychometric properties, including acceptability, dimensionality, reliability, validity (including cross-cultural), and responsiveness, was demonstrated, particularly for the EHP-30. Strikingly, using anchor-based methods, EHP-30 responsiveness studies demonstrate the largest mean changes in the 'control and powerlessness' domain post-intervention, followed by 'pain'. MMAT outcomes indicated the quality of the papers was good, with the exception of five studies. A meta-analysis was not undertaken owing to the heterogeneity of the interventions and papers included in this review., Wider Implications: Women with endometriosis face a lifetime of surgical and/or medical interventions to keep the condition under control. Less invasive treatments that can lead to improved longer term physical and psycho-social outcomes are needed. The EHPs are reliable, valid, acceptable, and responsive tools, but more assessment of EHP outcomes using modern psychometric methods and in the context of women from ethnically diverse backgrounds and in routine clinical care would be beneficial. Given the brevity of the EHP-5, it may be the most appropriate version to use in routine clinical practice, whereas the longer EHP-30, which provides more granularity, is more appropriate for research., (© The Author(s) 2023. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology.)

Objective: A qualitative sub-study was carried out within a larger phase II feasibility trial, to identify and describe the burden experienced by advanced melanoma patients participating in a clinical trial and the factors affecting their capacity to cope with the burden., Methods: Semi-structured interviews were conducted with fourteen patients with advanced melanoma recruited from National Health Service hospitals in the United Kingdom. Qualitative analysis was undertaken using a framework analysis approach. Normalisation process theory was applied to the concept of research participation burden in order to interpret and categorise findings., Results: Burdens of participation were identified as arising from making sense of the trial and treatment; arranging transport, appointment and prescriptions; enacting management strategies and enduring side effects; reflecting on trial documents and treatment efficacy, and emotional and mental effects of randomisation and treatment side effects. Factors reported as influencing capacity include personal attributes and skills, physical and cognitive abilities and support network., Discussion: This is the first study to highlight the substantial burden faced by patients with advanced melanoma in a clinical trial and factors that may lessen or worsen the burden. Consideration of identified burdens during trial design and execution will reduce the burden experienced by research participants.

Background: Fatigue and breathlessness are the two most common and distressing symptoms for patients with chronic heart failure. They affect a patient's quality of life and ability to undertake activities of daily living. Currently there are no symptom specific measures for fatigue and breathlessness available or developed and validated for use with this patient group and no questionnaire that incorporates both symptoms into one measure., Objective: To develop a patient-reported outcome measure for patients with chronic heart failure for their fatigue and breathlessness symptoms., Methods: A three-staged, approach was used. In stage One in-depth qualitative patient-interviews on factors of fatigue and breathlessness in chronic heart failure were undertaken to provide question themes. Items from these interviews were generated and pilot questionnaires developed and tested. In Stage Two, exploratory factor analysis with item reduction and final testing of the questionnaire was performed. Stage Three involved validation testing., Results: In Stage One, issues raised in interviews (n = 25) were used to generate items. Pilot questionnaires were developed and tested. Items were refined in the context of cognitive debrief interviews (n = 7) for possible inclusion in the final measure. Final testing of questionnaire properties with item reduction was carried out in Stage Two (n = 112). Validity and reliability were assessed in Stage Three (n = 96). Psychometric testing showed positive results, in internal consistency (Cronbach's alpha ranging from 0.8 to 0.94) and test-retest (no difference in means), content validity and relevance to patients., Conclusions: This questionnaire could be useful in the assessment of fatigue and breathlessness in patients living with chronic heart failure., Competing Interests: Declaration of Competing Interests The authors have no conflicts of interest to declare., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Aims: The aim of this study was to develop and evaluate machine-learning-based computerized adaptive tests (CATs) for the Oxford Hip Score (OHS), Oxford Knee Score (OKS), Oxford Shoulder Score (OSS), and the Oxford Elbow Score (OES) and its subscales., Methods: We developed CAT algorithms for the OHS, OKS, OSS, overall OES, and each of the OES subscales, using responses to the full-length questionnaires and a machine-learning technique called regression tree learning. The algorithms were evaluated through a series of simulation studies, in which they aimed to predict respondents' full-length questionnaire scores from only a selection of their item responses. In each case, the total number of items used by the CAT algorithm was recorded and CAT scores were compared to full-length questionnaire scores by mean, SD, score distribution plots, Pearson's correlation coefficient, intraclass correlation (ICC), and the Bland-Altman method. Differences between CAT scores and full-length questionnaire scores were contextualized through comparison to the instruments' minimal clinically important difference (MCID)., Results: The CAT algorithms accurately estimated 12-item questionnaire scores from between four and nine items. Scores followed a very similar distribution between CAT and full-length assessments, with the mean score difference ranging from 0.03 to 0.26 out of 48 points. Pearson's correlation coefficient and ICC were 0.98 for each 12-item scale and 0.95 or higher for the OES subscales. In over 95% of cases, a patient's CAT score was within five points of the full-length questionnaire score for each 12-item questionnaire., Conclusion: Oxford Hip Score, Oxford Knee Score, Oxford Shoulder Score, and Oxford Elbow Score (including separate subscale scores) CATs all markedly reduce the burden of items to be completed without sacrificing score accuracy.Cite this article: Bone Jt Open  2022;3(10):786-794.

Introduction: The PDQ-Carer is a 29-item measure of health-related quality of life (QoL) for use with carers of people with Parkinson's (PwP). The measure produces a profile of scores across four domains. Previous validation data indicates that the measure possesses sound psychometric properties in terms of validity and internal consistency. An additional important attribute of any measure is test-retest reliability, i.e. the ability to provide stable results over time, presuming that there has been no change in the status of the construct being measured. To date, no assessment of the test-retest reliability of the PDQ-Carer has been undertaken., Methods: Carers of PwP were recruited via Parkinson's UK. Participants completed the PDQ-Carer online on two occasions, two weeks apart. On second administration participants answered an additional question asking how much, if at all, their QoL had changed over the two week period. Subsequent analyses focused on those carers who reported no change in their QoL., Results: At first administration 142 carers fully completed the PDQ-Carer and at second administration 104 participants with no missing data responded. Seventy four of these participants (71.2%) reported no change in QoL and thus went forward to the final analysis. Intraclass correlation coefficients for each domain were calculated as follows: Social and Personal Activities .97; Anxiety and Depression .95; Self-Care .96; Stress .95 CONCLUSION: Results indicate that the PDQ-Carer demonstrates sound test-retest reliability and can be confidently used by researchers who wish to incorporate it in studies of carers of PwP., Competing Interests: Declaration of competing interest All authors have conducted consultancy work for Oxford University Outcomes who manage the license for the PDQ-Carer., (Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Introduction: Informal carers support persons with dementia to live at home, even with deteriorating physical, social and cognitive issues. This study aims to examine the experiences and impact of Assistive Technology (AT) on carers, providing care for a person with dementia., Methods: This is an explanatory sequential mixed methods study. The quantitative phase was an online and postal survey using the Carers Assistive Technology Experience Questionnaire and Short Form-12 (SF-12) questionnaire, with carers of persons with dementia in the UK, who used AT. The qualitative phase involved in-depth telephone interviews with a purposive sample of survey respondents and was analysed using hermeneutic phenomenology to develop, compare and explain the findings of the survey., Results: The survey included data from 201 carers. Smartphones (45.5%) and tablet computers (45.0%) were the most frequently used AT. Multiple AT were used in the care of persons with dementia predominantly for safety (78.5%), communication (66.0%), and reminders (62.5%). The SF-12 indicated that carers in the 46-65 age group and carers who were not extremely satisfied with AT had lower mental component scores whilst carers who lived with the person with dementia and older carers had lower physical component scores. Twenty-three carers participated in the interviews, and 5 themes with 14 sub-themes were identified. The interviews helped confirm data from the survey on the impact of AT on the physical, mental and social wellbeing of the carers. It helped describe reasons for satisfaction with AT; how AT was used in daily life and strengthened caring relationships and how wider support systems enhanced the care of a person with dementia using AT., Conclusions: This study describes the use of AT in the real-world context. AT supplements the care provided to people with dementia in the community. Appropriate use, access to AT and abilities of the carer can enhance the support provided through AT to both carers and the person with dementia., (© 2022. The Author(s).)

Importance: Many people with Parkinson disease (PD) develop motor complications that are uncontrolled by levodopa dose adjustment. Among these patients, it is uncertain which drug class is more effective as adjuvant therapy., Objective: To compare the long-term effects on patient-rated quality of life of adding a dopamine agonist vs a dopamine reuptake inhibitor (DRI), either a monoamine oxidase type B (MAO-B) inhibitor or a catechol-O-methyltransferase (COMT) inhibitor, to levodopa therapy for the treatment of patients with motor complications of PD., Design, Setting, and Participants: This pragmatic semifactorial (2 × 1) randomized clinical trial recruited from 64 neurology and geriatric clinics (62 in the United Kingdom, 1 in the Czech Republic, and 1 in Russia) between February 23, 2001, and December 15, 2009. A total of 500 patients with idiopathic PD who developed uncontrolled motor complications and did not have dementia were randomly assigned on a 1:1:1 basis using a computerized minimization program. Data were analyzed between 2017 and 2020., Interventions: Open-label dopamine agonist, MAO-B inhibitor, or COMT inhibitor., Main Outcomes and Measures: Primary outcomes were scores on the 39-item Parkinson's Disease Questionnaire (PDQ-39) mobility domain and cost-effectiveness. Outcomes were assessed before study entry, at 6 and 12 months after randomization, and annually thereafter. Repeated-measures and log rank analyses were used in an intention-to-treat approach., Results: Among 500 participants, the mean (SD) age was 73.0 (8.2) years; 314 participants (62.8%) were men. Over a median of 4.5 years (range, 0-13.3 years) of follow-up, the participants in the dopamine agonist group had a mean PDQ-39 mobility score that was 2.4 points (95% CI, -1.3 to 6.0 points) better than that of the combined MAO-B and COMT groups; however, this difference was not significant (P=.20). With regard to DRIs, participants in the MAO-B group had mean PDQ-39 mobility scores that were 4.2 points (95% CI, 0.4-7.9 points; P=.03) better than those of the COMT group and EuroQol 5-dimension 3-level (EQ-5D-3L) utility scores that were 0.05 points (95% CI, 0.003-0.09 points; P=.04) better than the COMT group. Nonsignificant improvements were found in the PDQ-39 summary index (mean difference, 2.2 points; 95% CI, -0.2 to 4.5 points; P=.07) along with nonsignificant reductions in dementia (rate ratio [RR], 0.70; 95% CI, 0.47-1.03; P = .07) and mortality (RR, 0.76; 95% CI, 0.56-1.03; P=.07). When dopamine agonists were compared with MAO-B inhibitors only, the outcomes were similar., Conclusions and Relevance: In this study, patient-rated quality of life was inferior when COMT inhibitors were used as adjuvant treatment compared with MAO-B inhibitors or dopamine agonists among people with PD who experienced motor complications that were uncontrolled by levodopa therapy. The MAO-B inhibitors produced equivalent disease control, suggesting that these agents may be underused as adjuvant therapy., Trial Registration: isrctn.org Identifier: ISRCTN69812316; EU Clinical Trials Register Identifier: 2005-001813-16.

Background: informal carers provide the majority of the support for persons with dementia living at home. Restrictions imposed due to COVID-19 have had a profound impact on the daily life of the entire population. This study provides insight into the impact of these restrictions on carers of people with dementia living at home., Design: qualitative semi-structured interviews., Participants: purposive sample of carers who provide at least 10 hours of care a week for the person with dementia living at home., Setting: UK., Results: twenty-three carers were interviewed, and thematic analysis identified three main themes-Changes to daily life, impact on carer health and wellbeing and reduced support from health and social support networks. The results highlight the impact of restrictions imposed on daily life and routines due to the pandemic, wellbeing of carers, reduced social support, lack of access to health and care professionals and respite for carers. The restrictions have had negative consequences on carers' wellbeing, and they have experienced difficulties in accessing formal care services and respite care., Conclusion: carers attempt to continue to provide physical, emotional and practical support for persons with dementia in the community throughout the COVID-19 restrictions. To prevent a future carer crisis, carers need better support systems including formal carer services, telecare solutions that work for them and additional support for respite, as the restrictions from this pandemic continue., (© The Author(s) 2021. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: The early postoperative recovery period following unicompartmental (UKA) and total knee arthroplasty (TKA) is an important area for research with increasingly sensitive metrics and new technologies. This study uses 2 recently developed patient-reported scores to compare the recovery following UKA and TKA., Methods: Two consecutive cohorts of 37 UKAs and 33 TKAs completed the Oxford Arthroplasty Early Recovery Score (OARS) and the Oxford Arthroplasty Early Change Score (OACS) on days 1, 2, 3, 7, 14, and week 6. The Short Form-36 version 2 was also completed on weeks 1, 2, and 6. Improvements within cohorts and comparisons between cohorts were assessed., Results: For both UKA and TKA the speed of recovery was rapid early on and then progressively decreased. At all time points, the UKA cohort reported similar or significantly better scores than the TKA cohort. The overall OARS (P < .001) showed that UKA recovered, shown as improvement on the OARS, 2-3 times faster than TKA. OARS subscales demonstrated that UKA had better Function/Mobility (P = .003) particularly early in the recovery, and better Nausea/Feeling Unwell (P < .001) and Fatigue/Sleep (P = .009) later in the recovery. UKA also had less pain at 2 weeks (P = .03). There was no significant difference between UKA and TKA OACS. UKA had significantly better scores in 3 of the 8 Short Form-36 domains, with the largest difference being in Role-Emotional (P = .003)., Conclusion: The OARS is useful for the assessment of postoperative recovery. This study provides direct evidence that recovery following UKA is better and 2-3 times faster than following TKA. All differences may be explained by the less invasive nature of UKA., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: The PD MED study reported small but persistent benefits in patient-rated mobility scores and quality of life from initiating therapy with levodopa compared with levodopa-sparing therapies in early Parkinson's disease (PD)., Objectives: The objective was to estimate the cost-effectiveness of levodopa-sparing therapy (dopamine agonists or monoamine oxidase type B inhibitors compared with levodopa alone., Methods: PD MED is a pragmatic, open-label randomized, controlled trial in which patients newly diagnosed with PD were randomly assigned between levodopa-sparing therapy (dopamine agonists or monoamine oxidase type B inhibitors ) and levodopa alone. Mean quality-adjusted life-years and costs were calculated for each participant. Differences in mean quality-adjusted life-years and costs between levodopa and levodopa-sparing therapies and between dopamine agonists and monoamine oxidase type B inhibitors were estimated using linear regression., Results: Over a mean observation period of 4 years, levodopa was associated with significantly higher quality-adjusted life-years (difference, 0.18; 95% CI, 0.05-0.30; P < 0.01) and lower mean costs (£3390; £2671-£4109; P < 0.01) than levodopa-sparing therapies, the difference in costs driven by the higher costs of levodopa-sparing therapies. There were no significant differences in the costs of inpatient, social care, and institutional care between arms. There was no significant difference in quality-adjusted life-years between those allocated dopamine agonists and monoamine oxidase type B inhibitors (0.02; -0.17 to 0.13 in favor of dopamine agonists; P = 0.81); however costs were significantly lower for those allocated monoamine oxidase type B inhibitors (£2321; £1628-£3015; P < 0.01) because of the higher costs of dopamine agonists. There were no significant differences between arms for other costs., Conclusions: Initial treatment with levodopa is highly cost-effective compared with levodopa-sparing therapies. Monoamine oxidase type B inhibitors, as initial levodopa-sparing therapy was more cost-effective, with similar quality-adjusted life-years but lower costs than dopamine agonists. © 2021 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society., (© 2021 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.)

Background: Exercise is now a significant and key component in the management of Parkinson's disease. However, no self-report, Parkinson's-specific measure of exercise currently exists., Objective: To develop a patient-reported outcome measure (PROM) for use in studies and clinical trials that aim to assess the efficacy of exercise therapy for people with Parkinson's (PwP)., Methods: Participants were recruited via Parkinson's UK. To generate meaningful items, PwP participated in exploratory cognitive interviews. To pretest the items generated, PwP took part in two rounds of cognitive debrief interviews. Items were subsequently tested through an online survey that also included the eight-item Parkinson's Disease Questionnaire (PDQ-8) and Oxford Participation and Activities Questionnaire (Ox-PAQ)., Results: Twenty PwP were interviewed for item generation. Analyses identified issues related to adopting and maintaining exercise, resulting in the generation of 10 items. Fourteen PwP took part in subsequent cognitive debrief interviews. Following the first 10 interviews, one item was removed, and minor adjustments were made to the wording of two items. Four final interviews verified that no further adjustments were required. Consequently, nine items were included in the validation survey, which was fully completed by 398 PwP. Inspection of floor and ceiling effects resulted in the removal of two further items. A principal component analysis identified a single seven-item factor explaining 61.6% of variance. Further analyses indicated that the measure demonstrates sound reliability and validity., Conclusions: Results indicate that the PDQ-Exercise is an acceptable, reliable, and valid PROM. Further assessment of its psychometric properties is in progress. © 2021 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society., (© 2021 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.)

Background: Assistive Technology (AT) supports persons with dementia and their carers (family, friends and neighbours), yet little is known about experiences and the impact of AT on carers. We report on an exploratory survey that examined the types, uses, costs and impact of AT on carers as well as their quality of life., Methods: A cross-sectional survey using the Carers Assistive Technology Experience Questionnaire collected data from carers in the UK, who used at least one AT in the previous year and provided more than 10 h of care for a person with dementia, living at home. Carers completed the questionnaire online or on paper and information on AT, socio-demographic details, and Short-Form Health Survey (SF-12) data were collected. Descriptive and inferential statistics were used to report results and draw conclusions., Results: Data from 201 carers was analysed. Smartphones and tablet computers were the most frequently used AT. AT were used predominantly for safety, communication, and reminders. Carers usually make decisions on buying and continued use of AT. Multiple AT devices were used in the care of persons with dementia and number of AT used was associated with perceived satisfaction. Satisfaction with AT was not related to age, living arrangements and relationship of carers. From the SF-12, Mean Physical Component Score was 49.19 (95%CI- 47.75 to 50.63) and Mental Component Score was 45.37 (95%CI- 43.93 to 46.80). Women, carers in the 46-65 age group and carers who were not extremely satisfied with AT had lower MCS scores. Carers who lived with the person with dementia and older carers had lower PCS scores., Conclusions: Carers report that AT has a beneficial impact. Carers use multiple ATs, perceive AT to be satisfactory and recommend AT use to others. To support carers, we recommend establishment of centrally funded information sources and a loan store for AT. Further research on incremental addition of AT and changes to formal/paid care because of using AT should be undertaken. Practitioners, academics, manufactures and policy makers should consider the experiences of carers in research, development and use of AT to facilitate improved community living of people with dementia., (© 2021. The Author(s).)

Background: Many health care organizations want to improve their responses to patients who suffer medical injuries. Their ability to understand how well they meet patients' needs is limited by the lack of suitable instruments for assessing injured patients' experiences., Methods: This study aimed to generate items for a patient experience questionnaire that medical facilities can use to assess how well resolution met patients' needs. The Medical Injury Reconciliation Experiences Survey (MIRES) was based on findings from previous studies of New Zealand and American patients' experiences of non-litigation resolution of medical injuries. The researchers performed a content analysis of 24 transcripts from a stratified random sample of 92 interviews from the prior studies. Themes were extracted to develop a draft questionnaire, which was revised following feedback from experts. Cognitive debriefing interviews were conducted with 24 New Zealand and American injured patients., Results: There were 40 items in the following domains: perceptions of communications with health care providers after the injury (15 items), perceptions of remedial gestures (11 items), indicia of the patient's overall satisfaction with the reconciliation process (4 items), the nature and impacts of the injury (5 items), and patients' characteristics (5 items). Participants' feedback about the questionnaire was predominantly positive. Their suggestions led to 37 revisions., Conclusion: The MIRES was comprehensible and acceptable to this group of post-injury patients. While further testing is desirable, the MIRES offers promise as a practicable approach that health care organizations can use to assess how well their reconciliation processes met patients' needs., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

We describe the use of rapid cycle tests of change to pretest and develop a Carers Assistive Technology Experience Questionnaire for a survey of informal carers of persons with dementia. The Plan-Do-Study-Act (PDSA) cycle is a commonly used improvement process in healthcare settings. We used this method for conducting rapid cycle tests of change through cognitive interviews to pretest the questionnaire. The items for the questionnaire were developed based on an earlier systematic review and qualitative study. PDSA cycles were used incrementally with learning from each cycle used to inform subsequent changes to the questionnaire prior to testing on the next participant., Design: Qualitative with use of cognitive interviews through rapid cycle tests of change., Setting: UK., Results: Nine participants were recruited based on eligibility criteria and purposive sampling. Cognitive interviewing using think aloud and concurrent verbal probing was used to test the comprehension, recall, decision and response choice of participants to the questionnaire. Seven PDSA cycles involving the participants helped identify problems with the questionnaire items, instructions, layout and grouping of items. Participants used a laptop, smartphone and/or tablet computer for testing the electronic version of the questionnaire and one participant also tested the paper version. A cumulative process of presenting items in the questionnaire, anticipating problems with specific items and learning from the unanticipated responses from participants through rapid cycle tests of change allowed rich learning and reflection to progressively improve the questionnaire., Conclusion: Using rapid cycle tests of change in the pretesting questionnaire phase of research provided a structure for conducting cognitive interviews. Learning and reflections from the rapid testing and revisions made to the questionnaire helped improve the process of reaching the final version of the questionnaire, that the authors were confident would measure what was intended, rapidly and with less respondent burden., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Hip and knee replacement are effective procedures for end-stage arthritis that has not responded to medical management. However, until now, there have been no validated, patient-reported tools to measure early recovery in this growing patient population. The process of development and psychometric evaluation of the Oxford Arthroplasty Early Recovery Score (OARS), a 14-item patient-reported outcome measure (PROM) measuring health status, and the Oxford Arthroplasty Early Change Score (OACS) a 14-item measure to assess change during the first 6 weeks following surgery is reported., Patients and Methods: A five-phased, best practice, iterative approach was used. From a literature based starting point, qualitative interviews with orthopaedic healthcare professionals, were then performed ascertaining if and how clinicians would use such a PROM and change measure. Analysis of in-depth patient-interviews in phase one identified important patient-reported factors in early recovery which were used to provide questionnaire themes. In Phase two, candidate items from Phase One interviews were generated and pilot questionnaires developed and tested. Exploratory factor analysis with item reduction and final testing of the questionnaires was performed in phase three. Phase Four involved validation testing., Results: Qualitative interviews (n = 22) with orthopaedic healthcare professionals, helped determine views of potential users, and guide structure. In Phase One, factors from patient interviews (n = 30) were used to find questionnaire themes and generate items. Pilot questionnaires were developed and tested in Phase Two. Items were refined in the context of cognitive debrief interviews (n = 34) for potential inclusion in the final tools. Final testing of questionnaire properties with item reduction (n = 168) was carried out in phase three. Validation of the OARS and OACS was performed in phase four. Both measures were administered to consecutive patients (n = 155) in an independent cohort. Validity and reliability were assessed. Psychometric testing showed positive results, in terms of internal consistency and sensitivity to change, content validity and relevance to patients and clinicians. In addition, these measures have been found to be acceptable to patients throughout early recovery with validation across the 6 week period., Conclusions: These brief, easy-to-use tools could be of great use in assessing recovery pathways and interventions in arthroplasty surgery.

Background: A growing number of web-based and mobile health (mHealth) technologies have been developed to support type 2 diabetes self-management. Little is known about individuals' experiences with these technologies and how they support self-management. Appropriate tools are needed to understand how web-based and mHealth interventions may impact self-management., Objective: This study aimed to develop an instrument, the Diabetes Self-Management and Technology Questionnaire (DSMT-Q), to assess self-management among people living with type 2 diabetes who use web-based and mHealth technologies., Methods: A total of 36 candidate questionnaire items, drafted previously, were refined using cognitive debriefing interviews (n=8), expert consultation, and public patient involvement feedback. Item reduction steps were performed on survey data (n=250), and tests of validity and reliability were subsequently performed., Results: Following amendments, patients and experts found 21 items relevant and acceptable for inclusion in the instrument. Survey participants included 104 (41.6%) women and 146 (58.4%) men. Two subscales with high construct validity, internal consistency, and test-retest reliability were identified: "Understanding individual health and making informed decisions" and "Confidence to reach and sustain goals.", Conclusions: Analyses confirmed good psychometric properties in the DSMT-Q scales. This tool will facilitate the measurement of self-management in people living with type 2 diabetes who use web-based or mHealth technologies., (©Laura Kelly, Crispin Jenkinson, David Morley. Originally published in JMIR Diabetes (http://diabetes.jmir.org), 09.07.2020.)

Introduction: A significant paucity of literature exists relating to the impact on children of parental neurological disorder, with the exception of multiple sclerosis. The wider literature in this field (parental cancer, depression, alcoholism, HIV/AIDS) exhibits the many potential challenges young people might experience during serious parental illness. Given this, a literature review of parental neurological disorder is long overdue., Methods: This review is structured around the World Health Organisation (WHO) classification of neurological disorders. The WHO identifies 10 common neurological disorders; dementia, epilepsy, headache, multiple sclerosis, neuroinfections, neurological disorders associated with malnutrition, pain associated with neurological disorders, Parkinson's disease, stroke, and traumatic brain injury. A comprehensive search of the MEDLINE database was performed using key terms for each of the 10 conditions. Results for each condition were divided in to "negative", "positive and/or neutral" and "other" child responses., Results: The search yielded a total of 6247 titles, of which 184 underwent a full-text assessment. Sixty-five met all eligibility criteria and were thus included in the review. A number of negative issues emerged across parental conditions including the prevalence of child mood disorders, parent-child role reversal, children's need for information on the parental condition, the importance of family cohesion, the negative effect of parental psychopathology and differences between male and female children. A limited number of positive outcomes were evident in a minority of parental conditions. Outcomes measured and methodologies employed were highly heterogeneous., Conclusion: Children generally respond negatively to parental neurological disorder. Responses varied between neurological disorders, suggesting the need for parental disease-specific guidance and clinical management where required., Competing Interests: The authors report no conflicts of interest in this work., (© 2020 Hartman et al.)

Objective: Assistive technology (AT) can help carers (family, friends and neighbours) and people with dementia to stay well and safely at home. There are important gaps in what we know about experience of using AT from the perspective of carers of persons with dementia. This study investigates carers' experience of using AT in supporting and caring for persons with dementia who live at home., Design: Qualitative phenomenological study with semi-structured interviews to achieve data saturation and thematic analysis to identify key themes., Setting: Community-based within the UK., Participants: Twenty-three (14 women, 9 men) adult carers of persons with dementia who have used at least one AT device., Results: All participants reported benefiting to varying degrees from using AT. There were 5 themes and 18 subthemes that highlighted reasons for using AT and use of AT over time. Providing care for a person with dementia, motivation for using AT, changes to roles and routines, carer knowledge and skills for using AT and social, environmental and ethical considerations were the main themes. This study showed that AT can provide reassurance and support for carers of persons with dementia but there are difficulties with acquiring and continued use of AT as dementia progresses., Conclusions: Carers consider AT as an adjunct to care they provided in caring for a person with dementia. Use of AT should be considered in the personal, social and environmental context of persons with dementia and their carers. Further research and policy interventions are needed to address best use of resources and guidance on data sharing and data protection while using AT., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Musculoskeletal deformities and gait deviations are common features in ambulatory cerebral palsy (CP). Deformity correction through lower limb orthopaedic surgery is the standard form of care aimed at improving or preserving motor function. Current research on CP care does not always take into account individual patients' expectations and needs. There is a wide range of outcome domains and outcome measures used to assess outcome from treatment. This can lead to reporting bias and make it difficult to compare and contrast studies. A core outcome set (COS) would enhance the efficiency, relevance and overall quality of CP orthopaedic surgery research. The aim of this study is to establish a standardised COS for use in evaluating lower limb orthopaedic surgery for ambulatory children and young people with CP., Methods/analysis: A set of outcomes domains and outcome measures will be developed as follows: (1) a qualitative evidence synthesis to identify relevant outcomes from children and young people and family perspective; (2) a scoping review to identify relevant outcomes and outcome measures; (3) qualitative research to explore the experience of key stakeholders; (4) prioritisation of outcome domains will be achieved through a two-round Delphi process with key stakeholders; (5) a final COS will be developed at a consensus meeting with representation from key stakeholder groups., Ethics and Dissemination: Ethical approval for this study was granted in the UK by the Oxfordshire Research Ethics Committee B (REC reference 19/SC/0357). Informed consent will be obtained from participants taking part in the qualitative research and Delphi process. Study findings will be published in an open access journal and presented at relevant national and international conferences. Charities and associations will be engaged to promote awareness of the project COS results., Trial Registration Number: COMET registration: 1236., Prospero Registration Number: CRD42018089538., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

Background: The Oxford Participation and Activities Questionnaire (Ox-PAQ) is a 23-item patient-reported outcome measure (PROM) theoretically grounded in the World Health Organisation International Classification of Functioning, Disability and Health. Initial validation of the Ox-PAQ identified three domains; routine activities (14 items), emotional well-being (5 items) and social engagement (4 items). The purpose of the analyses reported here were to determine whether an overall index score can be calculated from the measure, and then to determine whether a shorter form measure can replicate results on the index score., Methods: Two surveys of people with long term conditions were undertaken. In the first study, higher order factor analysis is used to determine that a single index score can be calculated for the Ox-PAQ. Regression analyses are used to determine a sub-set of items selected for the Short Form Ox-PAQ (SF-Ox-PAQ). In the second study, results on the Ox-PAQ Single Index and SF-Ox-PAQ Single Index are compared with results from another generic measure, the EuroQol EQ-5D-5l., Results: Higher order factor analysis confirmed that a single index score can be created from the Ox-PAQ. Further, linear regression indicated 14 items could reliably and accurately produce this index. The two methods of creating the index were highly correlated (ICC =0.99). The two indices were found to provide almost identical levels of correlation with EQ-5D-5L scores., Conclusion: Results indicate that the Ox-PAQ can be summed to provide an index score, and, furthermore, a sub set of fourteen items can very closely replicate the results gained from the original parent form., Competing Interests: All authors are developers of the Ox-PAQ and will receive royalties from its use in commercial contexts. All authors have also undertaken consultancy work for Oxford University Innovation, the copyright holder of the Ox-PAQ. The authors report no other conflicts of interest in this work.

Background: Dementia is one of the greatest health and care priorities globally. Caring for persons with dementia is a challenge and often leads to negative psychological, physiological and financial consequences for informal carers (family members or friends). Many informal carers experience moderate to severe levels of burden. Advances in technology have the potential to assist persons with dementia and their carers, through assistive technology (AT) devices such as electronic medication dispensers, robotic devices and motion detectors. However, little is known about informal carers' experience and the impact of these technologies on them. This review aims to investigate the outcomes and experience of carers of persons with dementia, who live at home and use AT., Method: MEDLINE, Embase, CINAHL, AMED, ALOIS, PsycINFO, Trial registries and OpenGrey databases will be searched for studies of any design that have investigated carer experience and/or outcomes of AT use for persons with dementia living at home. Manual searches from reference lists of relevant papers will also be undertaken. Outcomes of interest are carers' self-reported outcomes (which include perceived burden, quality of life and wellbeing) and carer experiences (such as usefulness, benefits and disadvantages of AT and impact on caregiver/care receiver relationship). Two independent reviewers will screen identified papers with pre-defined eligibility criteria and extract data using a bespoke extraction form. Discrepancies will be resolved in discussion with a third reviewer. A synthesis of eligible studies and summary will be provided., Discussion: A systematic review of quantitative, qualitative and mixed methods evidence of informal carers' experience of AT use in dementia in the community will be carried out. It is anticipated that this will highlight (1) investigations on impact of AT use on carers, (2) outcome measures and experience questionnaires that have been used and (3) the types of studies carried out so far on this topic. The results from the review will be presented in a summary matrix of common types (e.g. mobile phones, alarms) and uses (e.g. communication, safety, personal care) of AT in dementia care and also identify AT that is not usually available through government or health system funding., Systematic Review Registration: PROSPERO CRD42017082268 .

Background: Dementia is a health and care priority globally. Caring for persons with dementia is a challenge and can lead to negative psychological, physiological and financial consequences for informal carers. Advances in technology have the potential to assist persons with dementia and their carers, through assistive technology devices such as electronic medication dispensers, robotic devices trackers and motion detectors. However, little is known about carers' experience and the impact of these technologies on them. This review aims to investigate the outcomes and experience of carers of persons with dementia, who live at home and use assistive technology., Methods: A systematic search in seven databases and manual searches were carried out using pre-defined inclusion and exclusion criteria to identify studies on carers of persons with dementia involving the use of assistive technology. The search identified 56 publications with quantitative, qualitative and mixed-method designs., Results: The studies reported positive and negative findings and focused on a wide variety of assistive technology devices. There were large differences in the uses of assistive technology, outcome measures used and the quality of studies. Knowledge and acceptance, competence to use and ethical issues when using assistive technology were themes that emerged from the studies. Carers generally appreciated using assistive technology and their experience of use varied., Conclusions: The intention of this systematic review is to list and classify the various types of assistive technology used by carers of persons with dementia and explores the positive and negative aspects, knowledge, acceptance and ethical issues in the use of assistive technology by carers of persons with dementia. We recommend the use of a standard and person-centred system of classifying and naming assistive technology devices and systems and for future research efforts in assistive technology to incorporate a family/carer centred model., Systematic Review Registration: PROSPERO - CRD42017082268 .

Background: The Oxford Participation and Activities Questionnaire (Ox-PAQ) is a recently validated 23-item generic patient reported outcome measure that is theoretically grounded in the World Health Organisation International Classification of Functioning, Disability and Health (ICF), as well as fully FDA compliant. The measure comprises three domains, Routine Activities (14 items), Emotional Well-Being (5 items) and Social Engagement (4 items), and has been shown to be both valid and reliable. The aim of this study was to make a preliminary assessment of the sensitivity to the change of the Ox-PAQ. Methods: Three hundred and seventy three people with either chronic pulmonary obstructive disease, motor neurone disease, multiple sclerosis or Parkinson's disease completed the Ox-PAQ electronically on two occasions, six months apart. Participants completed an additional four questions during the second administration of the Ox-PAQ in order to assess any relevant changes since baseline. For each of the three Ox-PAQ domains, the minimally important difference (MID) and effect size (ES) was calculated from those participants indicating small, but meaningful positive improvement. Results: Two hundred and ninety respondents were entered into the final analysis, 77.74% of the original sample. For those indicating "slight improvement" in Routine Activities (n=19), an MID of 7.51 and an ES of 0.32 was calculated. For Emotional Well-Being (n=26), the MID was 10.77 and the ES 0.44. For Social Engagement (n=16), the MID was 5.47 and the ES 0.28. Conclusion: Data presented provides MID improvement and effect sizes for Ox-PAQ domains that will act as preliminary guidance for those powering clinical trials assessing activity and participation. Future research with larger samples will provide further sensitivity to change data for the Ox-PAQ., Competing Interests: This research was presented at ISPOR Europe 2018 held in Barcelona, Spain, 10–14 November, 2018, as a poster with interim findings. The abstract was published in Value in Health, Volume 21, Supplement 3, S327. All authors are developers of the Ox-PAQ and will receive royalties from its use in commercial contexts. All authors have also undertaken consultancy work for Oxford University Innovation Ltd which holds the license for the Ox-PAQ. The authors report no other conflicts of interest in this work.

Purpose: The aim of this study was to explore health care professionals' perceptions and perspectives of surgery and early recovery for patients undergoing lower limb arthroplasty., Design: Thematic analysis with semi-structured qualitative interviews., Methods: Following ethical approval, interviews were performed with recovery room nurses (n=3), ward nurses (n=2), surgeons (n=5), anesthesiologists (n=5), physiotherapists (n=5), and occupational therapists (n=2). Data were analyzed using an in-depth narrative thematic analysis method. NVivo qualitative data analysis software was used., Findings: Three main themes evolved from the interviews: immediate patient recovery issues, discharge criteria, and priorities during hospitalization from health care providers' perspectives., Conclusions: The early postoperative recovery period can be a challenging time for health care providers and patients alike. However, identifying key areas of importance can provide insight and guide focus in clinical practice, thus improving patient recovery., (Copyright © 2018 American Society of PeriAnesthesia Nurses. Published by Elsevier Inc. All rights reserved.)

Aims: Explore the experience of living with fatigue in persons with advanced heart failure. Design: Single-setting, qualitative interview study. Methods: In-depth interviews were conducted from November 2012 - June 2013. Participant responses to open-ended questions were analysed using thematic analysis. Inclusion criteria: 18 years and older, diagnosis of New York Heart Association class III-IV heart failure with reduced ejection fraction and able to participate in interviews in their own language. Exclusion criteria was cognitive deficit Twenty-three participated in the study. Results: Participants (age 72.5 ± 9.5 years, 10/23 female), identified experiencing fatigue daily with 14/23 reporting it as their worst symptom or combined worst symptom with breathlessness. Three key themes were identified: fatigue as a physical barrier, psychological response to fatigue, and living with fatigue as a part of daily life. Conclusion: As heart failure progresses fatigue influences patients' daily life and may negatively affect self-care abilities however patients strive to adapt to these limitations.

Parkinson's disease (PD) is traditionally classified as a movement disorder because patients mainly complain about motor symptoms. Recently, non-motor symptoms of PD have been recognized by clinicians and scientists as early signs of PD, and they are detrimental factors in the quality of life in advanced PD patients. It is crucial to comprehensively understand the essence of behavioral assessments, from the simplest measurement of certain symptoms to complex neuropsychological tasks. We have recently reviewed behavioral assessments in PD research with animal models (Asakawa et al., 2016). As a companion volume, this article will systematically review the behavioral assessments of motor and non-motor PD symptoms of human patients in current research. The major aims of this article are: (1) promoting a comparative understanding of various behavioral assessments in terms of the principle and measuring indexes; (2) addressing the major strengths and weaknesses of these behavioral assessments for a better selection of tasks/tests in order to avoid biased conclusions due to inappropriate assessments; and (3) presenting new concepts regarding the development of wearable devices and mobile internet in future assessments. In conclusion we emphasize the importance of improving the assessments for non-motor symptoms because of their complex and unique mechanisms in human PD brains., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Following publication of the original article [1], the authors reported that the following notation wasn't used consistently.

Background: A better understanding of coeliac disease can be achieved by assessing health-related quality of life alongside clinical factors. Existing patient-reported outcome measures (PROMs) evaluating quality of life in coeliac disease have not been developed in accordance with the US Food and Drug Administration guidelines., Aim: To develop a PROM in accordance with best practice guidelines, capturing all aspects of quality of life important to adults with coeliac disease., Methods: Candidate items for the Coeliac Disease Assessment Questionnaire (CDAQ) were refined through item appraisal, expert review, cognitive interviews, and a translatability assessment. A cross-sectional survey determined further item reduction and the CDAQ's structure. The final CDAQ was administered alongside the Short Form Health Survey Version 2 (SF?36v2) in a second survey to assess construct validity and test-retest reliability., Results: Pre-testing the 64 candidate items revealed a range of issues which guided their refinement and reduction, resulting in the final CDAQ with 32 items representing 5 subscales: stigma (eight items), dietary burden (eight items), symptoms (five items), social isolation (five items), and worries and concerns (six items). Cronbach's alpha ranged between 0.82 and 0.88 for all domains. Further results showed CDAQ scores were more strongly correlated with the SF-36v2's mental health dimensions, as expected. Intraclass correlation coefficients ranged from 0.79 to 0.89., Conclusion: The CDAQ is a reliable and valid coeliac-specific measure that captures all aspects of quality of life important to adults with coeliac disease. Further work is underway to assess the CDAQ's responsiveness to change., (© 2018 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.)

Background: Missing data can introduce bias in the results of randomised controlled trials (RCTs), but are typically unavoidable in pragmatic clinical research, especially when patient reported outcome measures (PROMs) are used. Traditionally applied to the composite PROMs score of multi-item instruments, some recent research suggests that multiple imputation (MI) at the item level may be preferable under certain scenarios. This paper presents practical guidance on the choice of MI models for handling missing PROMs data based on the characteristics of the trial dataset. The comparative performance of complete cases analysis, which is commonly used in the analysis of RCTs, is also considered., Methods: Realistic missing at random data were simulated using follow-up data from an RCT considering three different PROMs (Oxford Knee Score (OKS), EuroQoL 5 Dimensions 3 Levels (EQ-5D-3L), 12-item Short Form Survey (SF-12)). Data were multiply imputed at the item (using ordinal logit and predicted mean matching models), sub-scale and score level; unadjusted mean outcomes, as well as treatment effects from linear regression models were obtained for 1000 simulations. Performance was assessed by root mean square errors (RMSE) and mean absolute errors (MAE)., Results: Convergence problems were observed for MI at the item level. Performance generally improved with increasing sample sizes and lower percentages of missing data. Imputation at the score and subscale level outperformed imputation at the item level in small sample sizes (n ≤ 200). Imputation at the item level is more accurate for high proportions of item-nonresponse. All methods provided similar results for large sample sizes (≥500) in this particular case study., Conclusions: Many factors, including the prevalence of missing data in the study, sample size, the number of items within the PROM and numbers of levels within the individual items, and planned analyses need consideration when choosing an imputation model for missing PROMs data.

Background: The recently validated Oxford Participation and Activities Questionnaire (Ox-PAQ) is a 23-item patient-reported outcome measure, theoretically grounded in the World Health Organization International Classification of Functioning, Disability and Health. The measure is specifically designed to assess participation and activity in people experiencing a range of health conditions. Initial validation of the Ox-PAQ identified three domains: Routine Activities (14 items), Emotional Well-Being (5 items), and Social Engagement (4 items). The purpose of the analysis reported here was to assess whether the Routine Activities domain of Ox-PAQ could be validated for use as a stand-alone measure without compromising its psychometric integrity., Methods: Three hundred and seventy-three patients with a diagnosis of either chronic obstructive pulmonary disease, multiple sclerosis, or Parkinson's disease were administered the Ox-PAQ in an online survey. The 14 items of the Routine Activities domain of the Ox-PAQ were subject to factor analytic techniques and assessed for reliability and validity., Results: Three hundred and forty-one patients fully completed the survey, a completion rate of 91.4%. The 14 items loaded onto one single factor with an eigenvalue of 9.29 explaining 66.35% of variance. Reliability was confirmed through corrected item-total correlations ranging from 0.880 to 0.594 and a Cronbach's alpha value of 0.96. Validity was demonstrated through significant differences in scores between the three disease groups assessed., Conclusion: Results indicate that the Ox-PAQ Routine Activities domain can be legitimately adopted as a stand-alone measure, the Oxford Routine Activities Measure, where researchers wish to focus primarily on the activity component of the Ox-PAQ. It should, however, be emphasized that where a full assessment of all areas of activity and participation highlighted as important during the development of the Ox-PAQ is required, all three domains of the full measure should be administered., Competing Interests: Disclosure All authors are developers of the Ox-PAQ and will receive royalties from its use in commercial contexts. All authors have also undertaken consultancy work for Oxford Univer sity Innovation Ltd which holds the license for the Ox-PAQ. The authors report no other conflicts of interest in this work.

Background: Coeliac-specific measures have been criticized for not complying with current guidance on the development of patient-reported outcome measures (PROMs). The aim of this study was to develop a measure to assess health-related quality of life in adults with coeliac disease (CD), in accordance with current guidance for PROM development., Methods: In-depth qualitative interviews were conducted with adults with CD. A thematic analysis was undertaken to develop a coding framework. All interviews were analyzed according to this framework. Interviewing continued until data saturation was achieved. Candidate items were developed on the basis of the interview findings., Results: The analysis revealed 6 themes: 1) symptoms, 2) gluten-free diet, 3) emotional health, 4) impact on activities, 5) relationships, and 6) financial issues. Data saturation was reached after 8 interviews, but a total of 23 interviews were conducted to include a wide enough range of diverse participants. From the themes, 64 candidate items (9 for symptoms, 15 for emotional health, 16 for gluten-free diet, 7 for relationships, 12 for impact on activities, and 5 for financial issues) were developed to form the first draft of the Coeliac Disease Assessment Questionnaire (CDAQ)., Conclusion: The 64 items reflect all the issues of importance to people with CD. Next, these items will be pretested and refined to lead to a shorter draft version of the CDAQ before it is administered in a survey to produce a final version with subscales., Competing Interests: Disclosure The authors report no conflicts of interest in this work.

Aims and Objectives: To explore the patients' perspective of surgery and early recovery when undergoing lower limb (hip or knee) arthroplasty., Background: Lower limb arthroplasty is a commonly performed procedure for symptomatic arthritis, which has not responded to conservative medical treatment. Each patient's perspective of the surgical process and early recovery period impacts on their quality of life., Design: Open, semistructured qualitative interviews were used to allow for a deeper understanding of the patient perspective when undergoing a hip or knee arthroplasty., Methods: Following ethical approval, 30 patients were interviewed between August and November 2016 during the perioperative period while undergoing an elective hip or knee arthroplasty (n = 30). The interviews were performed between the day of surgery and a nine-week postoperative clinic appointment. Data were analysed using an in-depth narrative thematic analysis method. NVivo qualitative data analysis software was used., Results: Seven main themes evolved from the interviews: "improving function and mobility", "pain", "experiences of health care", "support from others", "involvement and understanding of care decisions", "behaviour and coping" and "fatigue and sleeping"., Conclusions: The early postoperative recovery period is of vital importance to all surgical patients. This is no different for the orthopaedic patient. However, identifying key self-reported areas of importance from patients can guide clinical focus for healthcare professionals., Relevance to Clinical Practice: To have specific patient-reported information regarding key areas of importance during the perioperative phase is invaluable when caring for the orthopaedic surgical patient. It gives insight and understanding in to this increasing population group. This study has also served as a starting point in the development of a questionnaire which could be used to assess interventions in the lower limb arthroplasty population. These results will influence both items and content of the questionnaire., (© 2017 John Wiley & Sons Ltd.)

Purpose: Missing data are a potential source of bias in the results of RCTs, but are often unavoidable in clinical research, particularly in patient-reported outcome measures (PROMs). Maximum likelihood (ML), multiple imputation (MI), and inverse probability weighting (IPW) can be used to handle incomplete longitudinal data. This paper compares their performance when analyzing PROMs, using a simulation study based on an RCT data set., Methods: Realistic missing-at-random data were simulated based on patterns observed during the follow-up of the knee arthroscopy trial (ISRCTN45837371). Simulation scenarios covered different sample sizes, with missing PROM data in 10%-60% of participants. Monotone and nonmonotone missing data patterns were considered. Missing data were addressed by using ML, MI, and IPW and analyzed via multilevel mixed-effects linear regression models. Root mean square errors in the treatment effects were used as performance parameters across 1,000 simulations., Results: Nonconvergence issues were observed for IPW at small sample sizes. The performance of all three approaches worsened with decreasing sample size and increasing proportions of missing data. MI and ML performed similarly when the MI model was restricted to baseline variables, but MI performed better when using postrandomization data in the imputation model and also in nonmonotone versus monotone missing data scenarios. IPW performed worse than ML and MI in all simulation scenarios., Conclusion: When additional postrandomization information is available, MI can be beneficial over ML for handling incomplete longitudinal PROM data. IPW is not recommended for handling missing PROM data in the simulated scenarios., Competing Interests: Disclosure All authors are employed by the University of Oxford. The funding agreement ensured the authors’ independence in designing the study, interpreting the data, and writing and publishing the report. The authors report no other conflicts of interest in this work.

Purpose: The Relational Aspects of Care Questionnaire (RAC-Q) is an electronic instrument which has been developed to assess staff's interactions with patients when delivering relational care to inpatients and those accessing accident and emergency (A&E) services. The aim of this study was to reduce the number of questionnaire items and explore scoring methods for "not applicable" response options., Patients and Methods: Participants (n=3928) were inpatients or A&E attendees across six participating hospital trusts in England during 2015-2016. The instrument, consisting of 20 questionnaire items, was administered by trained hospital volunteers over a period of 10 months. Items were subjected to exploratory factor analysis to confirm unidimensionality, and the number of items was reduced using a range of a priori psychometric criteria. Two alternative approaches to scoring were undertaken, one treated "not applicable" responses as missing data, while the second adopted a problem score approach where "not applicable" was considered "no problem with care.", Results: Two short-form RAC-Qs with alternative scoring options were identified. The first (the RAC-Q-12) contained 12 items, while the second scoring option (the RAC-Q-14) contained 14 items. Scores from both short forms correlated highly with the full 20-item parent form score (RAC-Q-12, r =0.93 and RAC-Q-14, f =0.92), displayed high internal consistency (Cronbach's α: RAC-Q-12=0.92 and RAC-Q-14=0.89) and had high levels of agreement (intraclass correlation coefficient [ICC]=0.97 for both scales)., Conclusion: The RAC-Q is designed to offer near-real-time feedback on staff's interactions with patients when delivering relational care. The new short-form RAC-Qs and their respective method of scoring are reflective of scores derived using the full 20-item parent form. The new short-form RAC-Qs may be incorporated into inpatient surveys to enable the comparison of ward or hospital performance. Using either the RAC-Q-12 or the RAC-Q-14 offers a method to reduce missing data and response fatigue., Competing Interests: Disclosure The authors report no conflicts of interest in this work.

Background: The prevalence of type 2 diabetes is rising, placing increasing strain on health care services. Web-based and mobile technologies can be an important source of information and support for people with type 2 diabetes and may prove beneficial with respect to reducing complications due to mismanagement. To date, little research has been performed to gain an insight into people's perspectives of using such technologies in their daily management., Objective: The purpose of this study was to understand the impact of using Web-based and mobile technologies to support the management of type 2 diabetes., Methods: In-depth interviews were conducted with 15 people with type 2 diabetes to explore experiences of using Web-based and mobile technologies to manage their diabetes. Transcripts were analyzed using the framework method., Results: Technology supported the users to maintain individualized and tailored goals when managing their health. A total of 7 themes were identified as important to participants when using technology to support self-management: (1) information, (2) understanding individual health and personal data, (3) reaching and sustaining goals, (4) minimizing disruption to daily life, (5) reassurance, (6) communicating with health care professionals, and (7) coordinated care., Conclusions: Patients need to be supported to manage their condition to improve well-being and prevent diabetes-related complications from arising. Technologies enabled the users to get an in-depth sense of how their body reacted to both lifestyle and medication factors-something that was much more difficult with the use of traditional standardized information alone. It is intended that the results of this study will inform a new questionnaire designed to assess self-management in people using Web-based and mobile technology to manage their health., (©Laura Kelly, Crispin Jenkinson, David Morley. Originally published in JMIR Diabetes (http://diabetes.jmir.org), 11.05.2018.)

Purpose: Spousal violence against women is a global public health problem. In India, approximately 40% of women report spousal violence. Like physical and sexual violence, emotional violence may be a determinant of women's health. This study explores the association between exposure to spousal emotional abuse and poor reproductive outcomes in Indian women., Methods: Data on 60,350 women, collected in the Third Indian National Family Health Survey were analysed to assess the impact of spousal emotional abuse on seven reproductive outcomes: age at first birth, number of children, terminated pregnancies, unwanted pregnancies, access to prenatal and skilled delivery care, and breastfeeding. Spousal emotional abuse was assessed using two overlapping constructs: emotional violence and controlling behaviour. Multivariable logistic regression was used for analysis., Results: Spousal emotional violence and controlling behaviour was reported by 16 and 38% of the women, respectively. In unadjusted analyses, spousal emotional violence was associated with all adverse reproductive outcomes, except breastfeeding. Controlling for socio-demographic risk factors attenuated the association, and further adjustment for other forms of violence removed all significant associations. Spousal controlling behaviour was significantly associated with all outcomes, except breastfeeding. The effects remained statistically significant in multivariable regression., Conclusions: Women's experience of violence may be under-reported. When other forms of violence were adjusted for, emotional violence was not associated with adverse reproductive outcomes, whereas controlling behaviour remained associated with all but one adverse reproductive outcome. Therefore, spousal controlling behaviour requires further investigation as a determinant of reproductive health.

Background: Comparisons between neurological conditions have the potential to inform service providers by identifying particular areas of difficulty experienced by affected individuals. This study aimed to identify predictors of activity and participation in people with motor neurone disease (MND), people with multiple sclerosis (MS) and people with Parkinson's Disease (PD)., Methods: The Oxford Participation and Activities Questionnaire (Ox-PAQ) and Medical Outcomes Study 36-Item Short Form Survey (MOS SF-36) were administered by postal survey to 386 people with a confirmed diagnosis of MND, MS or PD. Data analyses focused on stepwise regression analyses in order to identify predictors of activity and participation in the three conditions assessed., Results: Three hundred and thirty four participants completed the survey, a response rate of 86.5%. Regression analyses identified multiple predictors of activity and participation dependent on Ox-PAQ domain and disease group, the most prominent being social and physical functioning as measured by the MOS SF-36., Conclusions: Results indicate that the physical and social consequences of neurological illness are of greatest relevance to people experiencing the conditions assessed. Whilst the largely inevitable physical implications of disease take hold, emphasis should be placed on the avoidance of social withdrawal and isolation, and the maintenance of social engagement should become a significant priority.

Purpose: The aim of this study was to assess the quality of life, number of diseases and burden of morbidity of multimorbid primary care users and whether a simple disease count or a multimorbidity burden score is more predictive of quality of life., Patients and Methods: Primary care patients with at least 1 of 11 specified chronic conditions were invited to participate in a postal survey. Participants completed the Disease Burden Impact Scale (DBIS) questionnaire, the five dimension-five level Euro-Qol (EQ-5D-5L) and standard demographics questions. The DBIS asks participants to self-report chronic conditions and to rate the impact of each condition. Descriptive statistics and analysis of variance were used to determine quality of life, count of diseases and burden of morbidity. Multiple linear regression analyses determined whether disease count or the DBIS, adjusted for demographics, was more predictive of the EQ-5D-5L scores., Results: Thirty-one percent (n=917) responded, from which 69 were excluded as they reported no or only one condition, leaving 848 (92%) in the analysis. Slightly more women (50.9%) participated; the mean age was 67.0 (SD 13.9) and the mean number of conditions was 6.5 (SD 3.49). The mean scores were: DBIS 15.5 (SD 12.00; score range 0-140, with higher scores indicating higher multimorbidity burden), EQ-5D-5L score 0.69 (SD 0.28; score range -0.28 [a state worse than death] to 1 [best possible health state]) and EQ-5D Visual Analog Scale (EQ-VAS) 65.44 (SD 23.66; score range 0-100 with higher scores meaning better health). The model using the DBIS score was more predictive of the EQ-5D-5L score and EQ-VAS than the model using the disease count ( R 2 adj =0.53 using DBIS and R 2 adj =0.42 using disease count for EQ-5D-5L score, and R 2 adj =0.44 using DBIS versus R 2 adj =0.34 using disease count for EQ-VAS). All models were statistically significant ( p <0.001)., Conclusion: The DBIS is a useful measure for assessing multimorbidity from the perspective of primary care users in particular, as it is more predictive of health outcomes than a simple count of conditions., Competing Interests: Disclosure The authors report no conflicts of interest in this work.

Background: The Mild Cognitive Impairment Questionnaire (MCQ) is a 13-item measure that assesses health-related quality of life (HRQoL) in people with mild cognitive impairment (PWMCI); it has two domains assessing the emotional and practical effects., Objective: The aim of this study was to assess the psychometric properties of the MCQ., Design: This is a longitudinal questionnaire-based study., Setting: The participants were recruited from the memory clinics and research databases in the South of England., Subjects: A total of 299 people aged 50 years and older with a diagnosis of mild cognitive impairment confirmed within the preceding 12 months., Methods: MCQs were distributed to patients in memory clinics and those listed on research databases. Participants who returned completed questionnaires were sent a second copy of the MCQ to return 2 weeks after receiving the first questionnaire., Results: Five hundred and seven questionnaires were distributed; response rates were 68.2% initially and 89.2% for the second questionnaire. From the returned questionnaires, response rates for each item were high (>98%) and a full range of responses for each item was received with no evidence of significant floor or ceiling effects. Internal consistency reliability for both scale scores at both time points was good, with Cronbach's a ≥0.84 in all cases. Test-retest reliability was excellent for both domains with the intraclass correlation coefficients of 0.90 and 0.92 for the practical and emotional domains, respectively. Paired sample t -tests also confirmed the stability of scale score distributions over time., Conclusion: The MCQ has robust psychometric properties, which make it suitable for assessing HRQoL in PWMCI, including comparison of group level data in intervention studies., Competing Interests: Disclosure The Mild Cognitive Impairment Questionnaire is under copyright by Oxford University Innovation Limited. KD, CJ, and ZW may stand to gain financially should it be used for commercial purposes. The authors report no other conflicts of interest in this work.

Background: Patient reported outcome measures (PROMs) are widely used in mental healthcare research for quality of life assessment but most fail to capture the breadth of health and non-health domains that can be impacted. We report the psychometric validation of a novel, multi-dimensional instrument based on Amartya Sen's capability approach intended for use as an outcome measure in mental health research., Methods: The Oxford Capabilities Questionnaire for Mental Health (OxCAP-MH) is a 16-item self-complete capability measure that covers multiple domains of functioning and welfare. Data for validation of the instrument were collected through a national randomised controlled trial of community treatment orders for patients with psychosis. Complete OxCAP-MH data were available for 172 participants. Internal consistency was established with Cronbach's alpha; an interclass correlation coefficient was used to assess test-retest reliability in a sub-sample (N = 50) tested one week apart. Construct validity was established by comparing OxCAP-MH total scores with established instruments of illness severity and functioning: EuroQol (EQ-5D), Brief Psychiatric Rating Scale (BPRS), Global Assessment of Functioning (GAF) and Objective Social Outcomes Index (SIX). Sensitivity was established by calculating standard error of measurement using distributional methods., Results: The OxCAP-MH showed good internal consistency (Cronbach's alpha 0.79) and test-retest reliability (ICC = 0.86). Convergent validity was evidenced by strong correlations with the EQ-5D (VAS 0.52, p < .001) (Utility 0.45, p < .001), and divergent validity through more modest associations with the BPRS (-0.41, p < .001), GAF (0.24, p < .001) and SIX (0.12, p = ns). A change of 9.2 points on a 0-100 scale was found to be meaningful on statistical grounds., Conclusions: The OxCAP-MH has demonstrable reliability and construct validity and represents a promising multi-dimensional alternative to existing patient-reported outcome measures for quality of life used in mental health research.

Objective: The aim of this study was to validate a new generic patient-reported outcome measure, the Long-Term Conditions Questionnaire (LTCQ), among a diverse sample of health and social care users in England., Design: Cross-sectional validation survey. Data were collected through postal surveys (February 2016-January 2017). The sample included a healthcare cohort of patients recruited through primary care practices, and a social care cohort recruited through local government bodies that provide social care services., Participants: 1211 participants (24% confirmed social care recipients) took part in the study. Healthcare participants were recruited on the basis of having one of 11 specified long-term conditions (LTCs), and social care participants were recruited on the basis of receiving social care support for at least one LTC. The sample exhibited high multimorbidity, with 93% reporting two or more LTCs and 43% reporting a mental health condition., Outcome Measures: The LTCQ's construct validity was tested with reference to the EQ-5D (5-level version), the Self-Efficacy for Managing Chronic Disease scale, an Activities of Daily Living scale and the Bayliss burden of morbidity scale., Results: Low levels of missing data for each item indicate acceptability of the LTCQ across the sample. The LTCQ exhibits high internal consistency (Cronbach's α=0.95) across the scale's 20 items and excellent test-retest reliability (intraclass correlation coefficient=0.94, 95% CI 0.93 to 0.95). Associations between the LTCQ and all reference measures were moderate to strong and in the expected directions, indicating convergent construct validity., Conclusions: This study provides evidence for the reliability and validity of the LTCQ, which has potential for use in both health and social care settings. The LTCQ could meet a need for holistic outcome measurement that goes beyond symptoms and physical function, complementing existing measures to capture fully what it means to live well with LTCs., Competing Interests: Competing interests: Some authors had financial (salary) support from the two funding bodies: CMP, LK and EG from the NIHR via programme funding for CLAHRC Oxford, and LB, LG, DF, KJ and MP from the Department of Health England via programme funding for QORU policy research unit; the authors declare no financial relationships with any other organisations that might have an interest in the submitted work in the previous 3 years; the authors declare no other relationships or activities that could appear to have influenced the submitted work., (© 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.)

Aims and Objectives: To explore how patients with Chronic Heart Failure describe their experiences of breathlessness, the pattern of their breathlessness, how daily life is affected and how they adjust to and manage these symptoms., Background: Chronic Heart Failure is a highly prevalent syndrome often with poor outcomes and in a patient group who are predominately elderly. Breathlessness is the main symptom experienced by patients and often relates to decompensation and hospitalisation, yet subtle changes described by patients are often not discussed with health care professionals., Design: A descriptive qualitative design., Methods: Twenty-five participants with heart failure with reduced ejection fraction (HF-rEF) from a tertiary referral centre in England were recruited. Each participant took part in a semi-structured interview exploring the effect of breathlessness had on their lives. Data was analysed through Braun and Clarke's framework for thematic analysis., Results: All participants reported experiencing breathlessness daily. Four sub-themes were identified in their accounts: nature of breathlessness, emotional impact of breathlessness, impact of breathlessness on daily life and managing breathlessness., Conclusion: Participants were able to give vivid descriptions of breathlessness and the way it affected their lives., Relevance to Clinical Practice: Health care professionals need to take account of each patient's personal assessment of their own breathlessness and how this is having an effect on their life and ability to undertake activities of daily living. Self-care management strategies need to be developed so that subtle changes can be assessed by the patient and reviewed by the healthcare professional to avoid hospitalisation and increased mortality risks., (© 2016 John Wiley & Sons Ltd.)

Background: Lower limb arthroplasty is an effective surgical treatment option for patients with moderate to severe arthritis who have not responded to medical management. However, surgical interventions can lead to postoperative consequences such as limited mobility, pain, and infection. Consequently, improving postoperative recovery holds significant benefits for patients, health care professionals, and health care payers. The purpose of this review is to determine if any recovery tools exist that can effectively measure early postoperative recovery after hip or knee arthroplasty., Methods: The following databases were searched; PubMed (Ovid), EMBASE (Ovid), Medline (Ovid), Web of Science (ISI Web of Knowledge), PsycINFO, Applied Social Sciences Index and Abstracts, Cochrane library, and SCOPUS. We restricted our search to English language articles and adult respondents. Data were extracted by 2 independent reviewers using a proforma spreadsheet, and existing quality criteria were applied., Results: Our literature search identified 23 articles relating to development, assessment, and validation of 15 tools. Not all instruments demonstrated the same levels of quality. None of the tools found were specific to both the orthopedic arthroplasty population and early recovery periods., Conclusion: At the present time, there are no fully validated tools to assess early postoperative recovery during the first week following lower limb arthroplasty. A brief, easy-to-complete, reliable patient-reported tool could be of great use. It could not only aid in assessment of recovery but could also evaluate the efficacy of perioperative interventions such as drugs or surgical technique and provide a foundation for evidence-based care., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Purpose: It is a key UK government priority to assess and improve outcomes in people with long-term conditions (LTCs). We are developing a new patient-reported outcome measure, the Long-Term Conditions Questionnaire (LTCQ), for use among people with single or multiple LTCs. This study aimed to refine candidate LTCQ items that had previously been informed through literature reviews, interviews with professional stakeholders, and interviews with people with LTCs., Materials and Methods: Cognitive interviews (n=32) with people living with LTCs and consultations with professional stakeholders (n=13) and public representatives (n=5) were conducted to assess the suitability of 23 candidate items. Items were tested for content and comprehensibility and underwent a translatability assessment., Results: Four rounds of revisions took place, due to amendments to item structure, improvements to item clarity, item duplication, and recommendations for future translations. Twenty items were confirmed as relevant to living with LTCs and understandable to patients and professionals., Conclusion: This study supports the content validity of the LTCQ items among people with LTCs and professional stakeholders. The final items are suitable to enter the next stage of psychometric refinement., Competing Interests: The authors report no conflicts of interest in this work.

Background: Parkinson's caregivers are frequently affected by a range of physical and psychological factors affecting to the quality of life (QoL) of patients and caregivers. However, while there are well-validated QoL instruments for patients, few specific measures has been developed for caregivers of patients with PD. This study examined the psychometric properties of the Spanish version of the Parkinson Disease Questionnaire-Carer (PDQ-Carer) for use in PD caregivers., Methods: The PDQ-Carer and the Short Form-36 Health Survey (SF-36) were completed by sample of 73 caregivers of patients with PD in Spain (71.8 % females; 63.6 ± 12.3 years old)., Results: Psychometric analysis confirmed the reliability and validity of the Spanish version of the PDQ-Carer. The internal consistency was found to be satisfactory for the four PDQ-Carer domains: Personal and Social Activities, Depression and Anxiety, Self-care and Stress with Cronbach's alpha values ranging 0.80 to 0.95. The PDQ-Carer was significantly correlated with the eight SF-36 domains (r = -0.31 to -0.59, p < 0.001) supporting the concurrent validity of the instrument., Conclusions: Overall, these results provide preliminary evidence of the utility of the Spanish version of the PDQ-Carer in non-professionals caregivers.