Positive Outcomes

Validity, Reliability and Responsiveness of a Novel Person-Centred Outcome Measure for People With HIV

Richard Harding; Christopher Iain Jones; Stephen Bremner; Katherine Bristowe; Brian West; Richard J. Siegert; Kelly K. O'Brien; Jennifer Whetham

Disclosures

HIV Medicine. 2022;23(6):673-683. 

In This Article

Abstract and Introduction

Abstract

Objectives: Despite successful treatment, people living with HIV experience persisting and burdensome multidimensional problems. We aimed to assess the validity, reliability and responsiveness of Positive Outcomes, a patient-reported outcome measure for use in clinical practice.

Methods: In all, 1392 outpatients in five European countries self-completed Positive Outcomes, PAM-13 (patient empowerment), PROQOL-HIV (quality of life) and FRAIL (frailty) at baseline and 12 months. Analysis assessed: (a) validity (structural, convergent and divergent, discriminant); (b) reliability (internal consistency, test-retest); and (c) responsiveness.

Results: An interpretable four-factor structure was identified: 'emotional wellbeing', 'interpersonal and sexual wellbeing', 'socioeconomic wellbeing' and 'physical wellbeing'. Moderate to strong convergent validity was found for three subscales of Positive Outcomes and PROQOL (ρ = −0.481 to −0.618, all p < 0.001). Divergent validity was found for total scores with weak ρ (−0.295, p < 0.001). Discriminant validity was confirmed with worse Positive Outcomes score associated with increasing odds of worse FRAIL group (4.81-fold, p < 0.001) and PAM-13 level (2.28-fold, p < 0.001). Internal consistency for total Positive Outcomes and its factors exceeded the conservative α threshold of 0.6. Test-retest reliability was established: those with stable PAM-13 and FRAIL scores also reported median Positive Outcomes change of 0. Improved PROQOL-HIV score baseline to 12 months was associated with improved Positive Outcomes score (r = −0.44, p < 0.001).

Conclusions: Positive Outcomes face and content validity was previously established, and the remaining validity, reliability and responsiveness properties are now demonstrated. The items within the brief 22-item tool are designed to be actionable by health and social care professionals to facilitate the goal of person-centred care.

Introduction

Despite advances in antiretroviral therapy (ART), people living with HIV have worse health-related quality of life (HRQoL) than the general population.[1] This is due to their high burden of physical symptoms, poorer mental health and social and spiritual concerns.[2–6]

Good psychosocial care and communication with HIV professionals are associated with improvements in clinical outcomes, adherence and retention in care.[7,8] However, people living with HIV feel that routine clinical appointments do not always address the things that matter most to them, with implications for their engagement with, and outcomes from, treatment and care.[9,10]

Care that addresses the multidimensional concerns of people with HIV requires a person-centred approach, which is a core principle of quality healthcare.[11] The World Health Organization (WHO) global strategy for people-centred and integrated services recognizes that, particularly for long-term conditions, care must respond to the individual's preferences and concerns, and be coordinated around their needs.[12] The UNAIDS global HIV strategy would be strengthened by the proposed '4th 90', that is, optimizing HRQoL for people living with HIV.[13]

Health systems must focus beyond viral suppression to integrated, person-centred healthcare for people living with HIV.[14] Measurable improvement in patient-reported outcomes is the endpoint of quality healthcare.[15] However, there has been little consideration of what these person-centred outcomes should be, and how they could be measured and integrated into standard HIV care.

Person-centred care incorporating patient-reported outcome measures (PROMs) can improve quality of care, patient–clinician communication, clinical decision-making and patient outcomes.[16,17] Patient-reported outcomes also predict viral rebound,[4] all-cause hospitalization[18] and survival.[19] At a service level, PROMs ensure that care is directed towards those outcomes that matter most to the population, thereby promoting quality and equity.[20] They also serve to test the effectiveness of person-centred complex interventions[8] as end-points in drug trials to ensure patient-reported outcomes are not inferior for new treatments,[21] and as a screening tool.[22]

HIV community groups and professionals have advocated for person-centredness as standard of HIV care[23] and for a PROM to be used within routine practice.[24] A recent review found that there is currently no 'gold standard' HIV PROM.[25] HIV-specific PROMs have been developed for single dimensions (e.g. depression, stigma, disability)[26] and for the construct of HRQoL.[27] Some PROMs have been successfully implemented in routine HIV practice.[28] However, there is no single, brief, valid person-centred multidimensional tool that reflects the concerns of people with HIV and is adequately specific, responsive and actionable to drive and evaluate routine care.

This paper reports findings from a collaborative research programme to improve the person-centredness and quality of HIV care through the development and validation of a brief PROM called Positive Outcomes. The construct measured relates to symptoms and concerns of adults living with HIV, in line with the WHO definition of health, i.e. 'physical, mental and social well-being'.[29] Each item measures the extent to which the symptom or concern has affected the respondent in the previous 4 weeks. The intended purpose of the tool is two-fold: first, for use in routine clinical practice, enabling the person living with HIV and their clinicians to rapidly identify their most burdensome symptoms and concerns from a set of core outcomes that commonly affect this population; and second, for use as a valid outcome measure in research.

We previously used qualitative approaches to inform face and content validity of the tool and to determine end-user views on format and implementation.[30] Subsequent data described the community and multi-professional item generation process, and findings from cognitive interviews and refinement of the tool's 23 items, which include one open text item and one item of global well-being[31] (see Appendix S1 for full measure). The aim of the present phase of the study was to assess the validity, reliability and responsiveness of Positive Outcomes. Specific objectives were to assess: (a) validity (structural validity, convergent and divergent validity, discriminant validity); (b) reliability (internal consistency, test-retest reliability); and (c) responsiveness of the tool.

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