Measuring the effects of online health information: Scale validation for the e-Health Impact Questionnaire

AbstractObjectiveHealth-related websites have developed to be much more than information sites: they are used to exchange experiences and find support as well as information and advice. This paper documents the development of a tool to compare the potential consequences and experiences a person may encounter when using health-related websites.MethodsQuestionnaire items were developed following a review of relevant literature and qualitative secondary analysis of interviews relating to experiences of health. Item reduction steps were performed on pilot survey data (n=167). Tests of validity and reliability were subsequently performed (n=170) to determine the psychometric properties of the questionnaire.ResultsTwo independent item pools entered psychometric testing: (1) Items relating to general views of using the internet in relation to health and, (2) Items relating to the consequences of using a specific health-related website. Identified sub-scales were found to have high construct validity, internal consistency and test-retest reliability.ConclusionAnalyses confirmed good psychometric properties in the eHIQ-Part 1 (11 items) and the eHIQ-Part 2 (26 items).Practice implicationsThis tool will facilitate the measurement of the potential consequences of using websites containing different types of material (scientific facts and figures, blogs, experiences, images) across a range of health conditions

Patients experience of fatigue in advanced heart failure

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

Outcome selection and role of patient reported outcomes in contemporary cardiovascular trials: systematic review

Objectives To systematically assess the type of outcomes selected and the prevalence of patient reported outcomes in contemporary cardiovascular trials and to quantify any misuse or underuse of patient reported outcomes using a specially developed tool that would allow estimation of the relevance of such outcomes to clinical decision making

Development of a core outcome set for lower limb orthopaedic surgical interventions in ambulant children and young people with cerebral palsy: A study protocol

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

Psychometric validation of a multi-dimensional capability instrument for outcome measurement in mental health research (OxCAP-MH)

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

Developing approaches to the collection and use of evidence of patient experience below the level of national surveys

National approaches to collecting patient feedback provide trust level information which although can provide a benchmark for trusts often doesn’t provide information about specific services or patients experiences of pathways of care. This more granular level of data could be more informative for local service development and improvement. This research explored the feasibility and usefulness of such approaches. A conceptual model and standard questionnaire of patient experience was developed that might work across a range of services and pathways of care. Seven trusts were recruited as collaborating sites in which the model and survey instrument was tested. These were from different geographical locations and settings. The impact of the pilot and survey results on the improvement and development of services was evaluated. The service- line approach to capturing patient feedback was generally more feasible and considered of value for service improvement. The collection of patients’ experiences across pathways of care was more challenging in terms of the development of the survey and interpretation of results. However, many sites identified specific actionable areas for improvement. This study has shown that it is possible to develop and apply a standardised survey in a range of services and provides evidence that a consistent unified approach to monitoring patient experiences is feasible. However several methodological problems are acknowledged such as the availability of resources and capacity for improvements to services and care. Evidence is now particularly needed to establish how best to produce positive impact from patient feedback

Derivation and validation of a modified short form of the stroke impact scale

Background: The Stroke Impact Scale (SIS) is a stroke-specific, quality of life measure recommended for research and clinical practice. Completion rates are suboptimal and could relate to test burden. We derived and validated a short form-SIS. Methods and Results: We examined data from the Virtual International Stroke Trial Archive, generating derivation and validation populations. We derived a short form (SF-SIS) by selecting one item per domain of SIS, choosing items most highly correlated with total domain score. Our validation described agreement of SF-SIS with original SIS and the SIS-16, and correlation with Barthel Index, modified Rankin Scale, NIHSS, and EQ-5D visual analogue scales. We assessed discriminative validity, (associations between SF-SIS and factors known to influence outcome [age, physiological parameters and comorbidity]). We assessed face validity and acceptability by sharing the SF-SIS with a focus group of stroke survivors and multidisciplinary stroke healthcare staff. From 5549 acute study patients (mean age: 68.5 (SD:13) years; mean SIS :64 [SD:32]) and 332 rehabilitation patients (mean age 65.7 [SD:11]; mean SIS:61 [SD:11]), we derived an 8-item SF-SIS that demonstrated good agreement with original SIS and good correlation with our chosen functional and QOL measures (all rho&gt;0.70; p&lt;0.0001). Significant associations were seen with our chosen predictors of stroke outcome in the acute group (p&lt;0.0001). The focus group agreed with the choice of items for SF-SIS across 7/8 domains. Conclusions: Using multiple, complementary methods we have derived a short form SIS and demonstrated content, convergent and discriminant validity. This shortened SIS should allow collection of robust quality of life data with less associated test burden

The Long-Term Conditions Questionnaire (LTCQ): Conceptual framework and item development

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. 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 analysed 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 organising 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 (LTCQ). Conclusions: 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 draft of the measure. These initial items will undergo cognitive testing to refine the items prior to further validation in a survey

Multiple imputation for patient reported outcome measures in randomised controlled trials : advantages and disadvantages of imputing at the item, subscale or composite score level

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