A systematic review to determine use of the Endometriosis Health Profiles to measure quality of life outcomes in women with endometriosis.

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.

Developing and exploring the validity of a patient reported experience measure for adult inpatient diabetes care.

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.

Burden of cancer trial participation: A qualitative sub-study of the INTERIM feasibility RCT.

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.

The development of a patient reported outcome measure for fatigue and breathlessness for patients with chronic heart failure (OxFAB).

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.

Computerized adaptive testing for the Oxford Hip, Knee, Shoulder, and Elbow scores : accurate measurement from fewer, and more patient-focused, questions.

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.

Test-retest reliability of the PDQ-Carer.

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.

Carers using assistive technology in dementia care at home: a mixed methods study.

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.

Long-term Effectiveness of Adjuvant Treatment With Catechol-O-Methyltransferase or Monoamine Oxidase B Inhibitors Compared With Dopamine Agonists Among Patients With Parkinson Disease Uncontrolled by Levodopa Therapy: The PD MED Randomized Clinical Trial.

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.

Carers' experiences of assistive technology use in dementia care: a cross sectional survey.

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.

Impact of COVID-19 restrictions on carers of persons with dementia in the UK: a qualitative study.

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.

Early Recovery Following Total and Unicompartmental Knee Arthroplasty Assessed Using Novel Patient-Reported Measures.

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.

Development of an Exercise-Specific Parkinson's Disease Questionnaire: The PDQ-Exercise.

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.

Cost-Effectiveness of Dopamine Agonists and Monoamine Oxidase B Inhibitors in Early Parkinson's Disease.

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.

Assessing Patients' Experiences with Medical Injury Reconciliation Processes: Item Generation for a Novel Survey Questionnaire.

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.

Using rapid cycle tests of change to develop the Carers Assistive Technology Experience Questionnaire: a cognitive interview study in the UK.

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.

Development of a patient-reported outcome measure (PROM) and change measure for use in early recovery following hip or knee replacement.

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.

Web-Based and mHealth Technologies to Support Self-Management in People Living With Type 2 Diabetes: Validation of the Diabetes Self-Management and Technology Questionnaire (DSMT-Q).

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.

Young People's Response to Parental Neurological Disorder: A Structured Review.

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.