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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