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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 ten 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.

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.

Lilian Hartman,1 Crispin Jenkinson,2 David Morley2 1Lincoln College, University of Oxford, Oxford OX1 3DR, UK; 2Nuffield Department of Population Health, University of Oxford, Oxford OX3 7LF, UKCorrespondence: David Morley Tel +44 1865 289432Email david.morley@ndph.ox.ac.ukIntroduction: 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 cond

Aims: To explore the experience of fatigue and living with fatigue in persons with advanced heart failure. Design: Single-setting, qualitative interview study. Methods: In-depth in-person interviews were conducted with participants from November 2012 to June 2013. Participant responses to open-ended questions were analysed using thematic content analysis. Inclusion criteria were: 18 years and older, diagnosis of New York Heart Association class III-IV heart failure with reduced ejection fraction by a consultant cardiologist, and able to participate in conversational-style interviews in their own language. Major exclusion criteria was cognitive deficit identified by Abbreviated Mental Test Score. Twenty-three adults participated in the study. Results: Participants (age 72.5 ± 9.5 years, 10/23 female, 17/23 New York Heart Association class III, and 6/23 class IV) identified experiencing fatigue almost daily with over 14/23 reporting it as their worst symptom or combined worst symptom with breathlessness. 9/23 identified fatigue as their second-worst symptom. Three key themes were identified: fatigue as a physical barrier, psychological response to fatigue, and living with fatigue as a part of daily life. The three themes however combine to influence a patients well-being and we suggest need to be acknowledged when planning self-care management. 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. Understanding the patient experience of fatigue and living with fatigue is important to optimize health management strategies.

Crispin Jenkinson, Laura Kelly, Sarah Dummett, David MorleyHealth Services Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford OX3 7LF, UKBackground: 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.Keywords: activity, participation, routine activities, higher order factor analysis, summary index

David Morley, Sarah Dummett, Laura Kelly, Crispin JenkinsonNuffield Department of Population Health, University of Oxford, Oxford OX3 7LF, UKBackground: 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 cha

Katherine Dean,1 Zuzana Walker,2 Crispin Jenkinson1 1Health Services Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, 2Division of Psychiatry, University College London, London, UK 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 α≥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 HRQ

Michele Peters,1 Laura Kelly,1 Caroline M Potter,1 Crispin Jenkinson,1 Elizabeth Gibbons,1 Julien Forder,2 Ray Fitzpatrick1 1Health Services Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, 2Personal Social Services Research Unit, School of Social Policy Sociology and Social Research, University of Kent, Canterbury, UK 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

Ines Rombach,1,2 Crispin Jenkinson,3 Alastair M Gray,1 David W Murray,2 Oliver Rivero-Arias4 1Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK; 2Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; 3Health Services Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK; 4National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK 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

Helen Crocker, Crispin Jenkinson, Michele Peters Health Services Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK 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. Keywords: coeliac disease, quality of life, patient-reported outcome measure, item development, qualitative, content validity, conceptual framework

David Morley, Sarah Dummett, Laura Kelly, Crispin Jenkinson Nuffield Department of Population Health, University of Oxford, Oxford, UK 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

Laura Kelly,1 Steve Sizmur,2 Susanne Käsbauer,2 Jenny King,2 Robyn Cooper,2 Crispin Jenkinson,1 Chris Graham2 1Health Services Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK; 2Research Division, Picker Institute Europe, Oxford, UK 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, r=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

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 (PDQCarer) 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.

Michele Peters,1 Caroline M Potter,1 Laura Kelly,1 Cheryl Hunter,1 Elizabeth Gibbons,1 Crispin Jenkinson,1 Angela Coulter,1 Julien Forder,2 Ann-Marie Towers,2 Christine A’Court,3,4 Ray Fitzpatrick1 1Health Services Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, 2Personal Social Services Research Unit, University of Kent, Canterbury, 3Nuffield Department of Primary Health Care Sciences, University of Oxford, Oxford, 4Broadshires Health Centre, Carterton, UK Purpose: To identify the main issues of importance when living with long-term conditions to refine a conceptual framework for informing the item development of a patient-reported outcome measure for long-term conditions.Materials and methods: Semi-structured qualitative interviews (n=48) were conducted with people living with at least one long-term condition. Participants were recruited through primary care. The interviews were transcribed verbatim and analyzed by thematic analysis. The analysis served to refine the conceptual framework, based on reviews of the literature and stakeholder consultations, for developing candidate items for a new measure for long-term conditions.Results: Three main organizing concepts were identified: impact of long-term conditions, experience of services and support, and self-care. The findings helped to refine a conceptual framework, leading to the development of 23 items that represent issues of importance in long-term conditions. The 23 candidate items formed the first draft of the measure, currently named the Long-Term Conditions Questionnaire.Conclusion: The aim of this study was to refine the conceptual framework and develop items for a patient-reported outcome measure for long-term conditions, including single and multiple morbidities and physical and mental health conditions. Qualitative interviews identified the key themes for assessing outcomes in long-term conditions, and these underpinned the development of the initial dra

Laura Kelly,1 Caroline M Potter,1 Cheryl Hunter,2 Elizabeth Gibbons,1 Ray Fitzpatrick,1 Crispin Jenkinson,1 Michele Peters1 1Health Services Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, 2Academic Unit of Primary Care, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK 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. Keywords: long-term conditions, chronic conditions, cognitive debrief interviews, patient-reported

David Morley, Sarah Dummett, Laura Kelly, Jill Dawson, Ray Fitzpatrick, Crispin Jenkinson Health Services Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK Purpose: There is growing interest in the management of long-term conditions and in keeping people active and participating in the community. Testing the effectiveness of interventions that aim to affect activities and participation can be challenging without a well-developed, valid, and reliable instrument. This study therefore aims to develop a patient-reported outcome measure, the Oxford Participation and Activities Questionnaire (Ox-PAQ), which is theoretically grounded in the World Health Organization's International Classification of Functioning, Disability, and Health (ICF) and fully compliant with current best practice guidelines. Methods: Questionnaire items generated from patient interviews and based on the nine chapters of the ICF were administered by postal survey to 386 people with three neurological conditions: motor neuron disease, multiple sclerosis, and Parkinson's disease. Participants also completed the Medical Outcomes Study (MOS) 36-Item Short Form Health Survey (SF-36) and EQ-5D-5L. Results: Thus, 334 participants completed the survey, a response rate of 86.5%. Factor analysis techniques identified three Ox-PAQ domains, consisting of 23 items, accounting for 72.8% of variance. Internal reliability for the three domains was high (Cronbach's α: 0.81–0.96), as was test–retest reliability (intraclass correlation: 0.83–0.92). Concurrent validity was demonstrated through highly significant relationships with relevant domains of the MOS SF-36 and the EQ-5D-5L. Assessment of known-groups validity identified significant differences in Ox-PAQ scores among the three conditions included in the survey. Conclusion: Results suggest that the Ox-PAQ is a valid and reliable measure of participation and acti

Laura Kelly, Crispin Jenkinson, Sarah Dummett, Jill Dawson, Ray Fitzpatrick, David Morley Health Services Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK Purpose: The Oxford Participation and Activities Questionnaire is a patient-reported outcome measure in development that is grounded on the World Health Organization International Classification of Functioning, Disability, and Health (ICF). The study reported here aimed to inform and generate an item pool for the new measure, which is specifically designed for the assessment of participation and activity in patients experiencing a range of health conditions. Methods: Items were informed through in-depth interviews conducted with 37 participants spanning a range of conditions. Interviews aimed to identify how their condition impacted their ability to participate in meaningful activities. Conditions included arthritis, cancer, chronic back pain, diabetes, motor neuron disease, multiple sclerosis, Parkinson's disease, and spinal cord injury. Transcripts were analyzed using the framework method. Statements relating to ICF themes were recast as questionnaire items and shown for review to an expert panel. Cognitive debrief interviews (n=13) were used to assess items for face and content validity. Results: ICF themes relevant to activities and participation in everyday life were explored, and a total of 222 items formed the initial item pool. This item pool was refined by the research team and 28 generic items were mapped onto all nine chapters of the ICF construct, detailing activity and participation. Cognitive interviewing confirmed the questionnaire instructions, items, and response options were acceptable to participants. Conclusion: Using a clear conceptual basis to inform item generation, 28 items have been identified as suitable to undergo further psychometric testing. A large-scale postal survey will follow in order to refine the instrument further and to assess i

Elizabeth Gibbons, Paul Hewitson, David Morley, Crispin Jenkinson, Ray Fitzpatrick Health Service Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK Background: This report presents evidence regarding the development and validation of a new questionnaire, the Outcomes and Experiences Questionnaire (OEQ). The rationale for the questionnaire is to bring together into one short instrument questions about two distinct domains – patients' reports of the outcomes of their care and how they experience care.Methods: The OEQ was developed from literature reviews, iterative drafting and discussion within the research group and cognitive testing with a sample of patients who had a hospital experience. Two validation studies were carried out with an eleven item OEQ. The goals of the studies were to examine response rates and to test specific hypotheses of how OEQ should relate to other variables normally collected in the two studies. In the first study, the OEQ was added to the follow-up questionnaires for patients (n=490) receiving surgery for hip or knee replacement or varicose vein procedures participating in the national Patient Reported Outcome Measures (PROMs) program permitting the analysis of the OEQ against change scores for the measures obtained before and after surgery. In the second study the OEQ was included in a sample of patients (n=586) who had been selected to receive the National Health Service (NHS) inpatient survey from three contrasting hospital trusts.Results: Results from study one provided consistent and substantial evidence of construct validity of OEQ particularly for those receiving hip or knee replacement. The OEQ sub-scales behaved differently and as predicted against other PROMs variables. Again hypotheses of how the two sub-scales regarding outcomes and experiences would relate to the existing domains of patient experience in the inpatient survey were broadly confirmed in study two.Conclusio

David Morley, Crispin Jenkinson University of Oxford, Nuffield Department of Population Health, Old Road Campus, Oxford, UK Abstract: A significant body of research has developed in recent years that has aided our understanding of how a range of conditions might affect the offspring of affected individuals. Research relating to the impact of parental Parkinson’s disease, however, is still in its relative infancy. This short paper focuses mainly, but not exclusively, on adolescence and briefly outlines findings to date. This is followed by a discussion of research that needs to be undertaken in order to further our understanding of the needs of children of people with Parkinson’s. Keywords: Parkinson’s disease, parent, adolescent, children

David Morley, Sarah Dummett, Laura Kelly, Jill Dawson, Ray Fitzpatrick, Crispin JenkinsonNuffield Department of Population Health, University of Oxford, Oxford, UKBackground: With an ageing population and increasing demands on health and social care services, there is growing importance attached to the management of long-term conditions, including maximizing the cost-effectiveness of treatments. In line with this, there is increasing emphasis on the need to keep people both active and participating in daily life. Consequently, it is essential that well developed and validated instruments that can meaningfully assess levels of participation and activity are widely available. Current measures, however, are largely focused on disability and rehabilitation, and there is no measure of activity or participation for generic use that fully meets the standards set by regulatory bodies such as the US Food and Drug Administration. Here we detail a protocol for the development and validation of a new patient-reported outcome measure (PROM) for assessment of participation and activity in people experiencing a variety of health conditions, ie, the Oxford Participation and Activities Questionnaire (Ox-PAQ). The stages incorporated in its development are entirely in line with current regulations and represent best practice in the development of PROMs.Methods: Development of the Ox-PAQ is theoretically grounded in the World Health Organization International Classification of Functioning, Disability, and Health. The project incorporates a new strategy of engaging with stakeholders from the outset in an attempt to identify those characteristics of PROMs considered most important to a range of potential users. Items will be generated through interviews with patients from a range of conditions. Pretesting of the instrument will be via cognitive interviews and focus groups. A postal survey will be conducted, with data subject to factor and Rasch analysis in order to identify appropriate

Widely accepted quality indicators for headache care would provide a basis not only for assessment of care but also, and more importantly, for its improvement. The objective of the study was to identify and summarize existing information on such indicators: specifically, did indicators exist, how had they been developed, what aspects of headache care did they relate to and how and with what utility were they being used? A systematic review of the medical literature was performed. A total of 32 articles met criteria for inclusion. We identified 55 existing headache quality indicators of which 37 evaluated processes of headache care. Most were relevant only to specific populations of patients and to care delivered in high-resource settings. Indicators had been used to describe overall quality of headache care at a national level, but not systematically applied to the evaluation and improvement of headache services in other settings. Some studies had evaluated the use of existing disability and quality of life instruments, but their findings had not been incorporated into quality indicators. Existing headache care quality indicators are incomplete and inadequate for purpose. They emphasize processes of care rather than structure or outcomes, and are not widely applicable to different levels and locations of headache care. Furthermore, they do not fully incorporate accepted evidence regarding optimal methods of care. There is a clear need for consensus-based indicators that fully reflect patients' and public-health priorities. Ideally, these will be valid across cultures and health-care settings.

The objective of this study was to define "quality" of headache care, and develop indicators that are applicable in different settings and cultures and to all types of headache. No definition of quality of headache care has been formulated. Two sets of quality indicators, proposed in the US and UK, are limited to their localities and/or specific to migraine and their development received no input from people with headache. We first undertook a literature review. Then we conducted a series of focus-group consultations with key stakeholders (doctors, nurses and patients) in headache care. From the findings we proposed a large number of putative quality indicators, and refined these and reduced their number in consultations with larger international groups of stakeholder representatives. We formulated a definition of quality from the quality indicators. Five main themes were identified: (1) headache services; (2) health professionals; (3) patients; (4) financial resources; (5) political agenda and legislation. An initial list of 160 putative quality indicators in 14 domains was reduced to 30 indicators in 9 domains. These gave rise to the following multidimensional definition of quality of headache care: "Good-quality headache care achieves accurate diagnosis and individualized management, has appropriate referral pathways, educates patients about their headaches and their management, is convenient and comfortable, satisfies patients, is efficient and equitable, assesses outcomes and is safe." Quality in headache care is multidimensional and resides in nine essential domains that are of equal importance. The indicators are currently being tested for feasibility of use in clinical settings.

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

Objectives To explore the views of a range of stakeholders regarding whether patient-reported outcome measures (PROMs) can be developed to measure key attributes of long-term conditions (LTCs) care in England, and the potential value of a single generic measure. Design Qualitative semistructured interview study, analysed using a framework approach. Participants and setting Interviews with 31 stakeholders from primary care, secondary care, social care, policy and patient-focused voluntary organisations in England. Results There was broad support for a single PROM that could be used to measure outcomes for patients with any LTCs in any health or social care setting. Interviewees identified three desired uses for a PROM: to improve the quality of individual care; to increase people's engagement in their own care; and to monitor the performance of services. Interviewees felt that a PROM for LTCs should incorporate a mixture of traditional and non-traditional domains, such as functioning, empowerment and social participation, and be codesigned with patients and professional end-users. Stakeholders emphasised the need for a PROM to be feasible for practical implementation at the individual clinical level as a first priority. A number of concerns and potential problems were identified in relation to the application and interpretation of an LTC PROM. Conclusions This study has demonstrated support for a single self-report outcome measure that reflects the priorities of people with LTCs, if such a measure can be shown to be meaningful and useful at the individual level. People with LTCs and professional end-users in health and social care should be involved in the development and evaluation of such a measure.