Development and Validation of a Clinic Screening Tool to Improve Clinical Management of Symptoms and Health-related Concerns in People Living with HIV in Spain
[eng] INTRODUCTION: Almost 38 million people were living with HIV at the end of 2020, 73% of whom were estimated to be receiving antiretroviral therapy (ART). The face of HIV has changed greatly since the first highly effective ART regimens were introduced in 1996, and PLHIV who initiate ART at a su...
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| Tipo de recurso: | tesis doctoral |
| Estado: | Versión publicada |
| Fecha de publicación: | 2022 |
| País: | España |
| Institución: | Universidad de Barcelona |
| Repositorio: | Dipòsit Digital de la UB |
| OAI Identifier: | oai:diposit.ub.edu:2445/184401 |
| Acceso en línea: | https://hdl.handle.net/2445/184401 http://hdl.handle.net/10803/673903 |
| Access Level: | acceso abierto |
| Palabra clave: | VIH (Virus) Símptomes Satisfacció dels pacients Serveis sanitaris Relacions metge-pacient HIV (Viruses) Symptoms Patient satisfaction Health services Physician-patient relationships |
| Sumario: | [eng] INTRODUCTION: Almost 38 million people were living with HIV at the end of 2020, 73% of whom were estimated to be receiving antiretroviral therapy (ART). The face of HIV has changed greatly since the first highly effective ART regimens were introduced in 1996, and PLHIV who initiate ART at a sufficiently early disease stage have a near-normal life expectancy. Yet their lives are markedly different in some ways from the lives of people without HIV. The prevalence of multimorbidity is higher in PLHIV than in the general population, with a wide range of infectious and noninfectious conditions contributing to the multimorbidity burden. PLHIV report being troubled by uncertainty about the future, and have high levels of depression and anxiety. Furthermore, even among PLHIV who have responded well to ART, some studies have documented poorer health-related quality of life (HRQoL) in comparison to that of the general population. PLHIV also report experiencing a high symptom burden, social isolation and multiple forms of HIV-related stigma. Improving the health and HRQoL of PLHIV in the context of high uptake of ART is the ultimate goal of the group of studies presented in the following thesis, which describes the development and piloting of a novel patient-reported outcome measure (PROM) for use in HIV clinical care in Spain. This work is timely because of the pressing need to rethink conventional approaches to HIV care in Spain and many other countries. From the mid-1990s onward, healthcare providers and public health experts have emphasised the importance of using ART to reduce viremia in PLHIV, while giving less attention to other health-related issues in this population. However, with growing awareness of the high burden and health effects of these other issues, it has become clear that conventional criteria for assessing the effectiveness of HIV care in terms of viral load outcomes and HIV-related mortality are insufficient. There are growing calls by researchers, PLHIV and other stakeholders for the HIV community to recognise the quality of life of PLHIV as a major healthcare concern. This changing paradigm is reflected in the UNAIDS Global AIDS Strategy for 2021–2026, which addresses “optimizing quality of life and well-being across the life-course”. Integrating people-centred healthcare principles and standards into clinical practice is an essential strategy for improving the HRQoL of PLHIV who are engaged in care. Taking a people-centred approach entails giving attention to the health-related issues that matter to individual PLHIV rather than merely focusing on how to halt HIV disease progression. There must be effective communication between patients and healthcare providers in order for patients’ needs and preferences to meaningfully inform their interactions with health systems. Various research findings call into question whether HIV care providers sufficiently understand their patients’ concerns. Studies have documented providers’ lack of awareness of clinically important symptoms in PLHIV patient populations, and PLHIV have reported communication barriers with their providers. There is also evidence that HIV care providers and PLHIV may not be in agreement about healthcare priorities. At the time of this writing, various stakeholders had published recommendations and guidance regarding the health-related needs of PLHIV beyond viral suppression, and the World Health Organization’s draft 2022–2030 strategy on HIV calls on countries to “address chronic care needs of adults and children living with HIV”. Clinical tools are needed to support healthcare providers in implementing this vision. PROMs can make an important contribution to the next chapter of HIV care by providing a structured mechanism for PLHIV to directly express health-related concerns to healthcare providers. PROMs may address a wide range of health-related issues and may be administered via interview, paper-based forms, or digital devices such as touch-screen tablets. Historically, they have had a more prominent role in research than in clinical practice. In recent years, there has been increasing interest in the potential for PROMs to contribute to clinical management across different healthcare fields, in part because of greater awareness of the principles of people-centred healthcare. When PROMS are used effectively in clinical practice, benefits may include greater provider awareness of health issues, improved patient-provider communication, more effective symptom management, and better health and HRQoL outcomes. There is currently an unmet need for short broadly focused PROMs that can give healthcare providers a convenient means of identifying disparate health-related challenges commonly experienced by PLHIV. The general objective of the body of research presented in this thesis is to design and pilot a PROM instrument that can be used in routine clinical practice to identify issues undermining the health-related quality of life of PLHIV in Spain, thus aiding health systems in responding more effectively to the long-term needs of this population beyond antiretroviral therapy. METHODS: The research presented in this thesis is based on three studies, which are presented in four articles. The first study was a policy survey that collected data from one expert in each of six European countries to investigate health system capacity to monitor aspects of healthcare such as mental health and psychosocial services. Findings are reported in Article 1. The second study used an observational cross-sectional ex-post-facto study design to validate the Spanish version of WHOQOL-HIV-BREF, a widely used HIV-specific HRQoL PROM, and to explore the HRQoL of Spanish PLHIV. Findings are reported in Article 2. The third study focused on the development of the CST-HIV in accordance with standard instrument development procedures. Findings from the first two phases of the study process, a literature review and a qualitative investigation of PLHIV and healthcare provider perceptions of issues that undermine the well-being of PLHIV in Spain, are reported in Article 3. Findings from the latter phases, including a Spanish pilot study assessing the psychometric properties of the new instrument, are reported in Article 4. RESULTS: The first article reports on a policy survey that investigated the national monitoring of HIV care issues in six European countries: Estonia, Italy, the Netherlands, Slovenia, Sweden and Turkey. The survey was administered in April–June 2018, with one purposively selected expert in each country providing information about health system monitoring capacity in relation to issues such as comorbidities, HRQoL, psychosocial services, and HIV-related discrimination in healthcare settings. According to respondents, only two countries (Slovenia and Sweden) had the capacity to monitor indicators addressing the screening, diagnosis and treatment of anxiety and depression. None of the respondents reported the use of national- level indicators to monitor the provision of psychosocial services. Respondents from three countries (the Netherlands, Slovenia and Sweden) indicated that their national monitoring systems had the capacity to report on the HRQoL of PLHIV. The second article reports on the validation of WHOQOL-HIV-BREF in a nationally representative sample of PLHIV in Spain (N=1,462) and on the HRQoL of this population. Data were collected between October 2016 and April 2017. Psychometric testing demonstrated that the Spanish version of the instrument has adequate construct, convergent and concurrent validity. Female study participants and heterosexual study participants had poorer HRQoL in comparison to their counterparts, as did people with low socioeconomic status, people who had been living with HIV for a longer period of time, and people older than 50. The third article reports on the literature review findings and focus group discussion findings that informed the early development of the CST-HIV. The literature review documented high prevalence of symptoms such as sleep-related problems, fatigue, and pain in PLHIV populations, and also identified studies that showed symptom burden and other issues such as social support, emotional health and material security to be associated with HRQoL in PLHIV. An analysis of data from the focus group discussions, two with HIV service providers (N=8 per group) and two with PLHIV (N=8 and N=7), identified a number of broad categories of issues impacting the HRQoL of PLHIV. The issues emphasised the most by both categories of focus group participants were social problems including HIV-related stigma and discrimination, sleep-related problems, fatigue, pain, and emotional distress. The fourth article reports on the entire CST-HIV instrument development process, including the definition of domains, development of potential items, expert assessment of items, cognitive debriefing interviews with eight PLHIV, and validation of the instrument in a cohort of 226 PLHIV in Spain. The eight domains chosen for the initial pilot instrument were anticipated stigma, emotional distress, sexuality, social support, material deprivation, sleep/fatigue, cognitive problems, and physical symptoms. Pilot findings confirmed the suitability of these domains, and led to the selection of three items per domain from among the 40 items used in the pilot instrument. The resulting 24-item instrument met standards for content, face, construct, convergent and concurrent validity. DISCUSSION AND CONCLUSIONS: The results of this thesis contribute to ongoing efforts to reorient HIV care to address the wide-ranging physical, emotional and social issues that challenge people who are living with HIV on a long-term basis. The PROM developed through this research, the CST-HIV, shows adequate preliminary validity and is currently undergoing additional validation to strengthen the evidence supporting its use in routine clinical care. To our knowledge, it is one of only three short validated instruments developed specifically to support HIV care providers in identifying a wide range of health-related issues that affect the well-being of PLHIV, and the only such instrument developed in Spain. The CST-HIV was developed through a methodologically rigorous process that closely followed best practices for instrument development. It displayed good psychometric properties in pilot testing, as well as evidence of convergent and concurrent validity. Its brevity and simplicity allow for rapid completion by clinic patients and easy assessment of data by healthcare workers. In light of these considerations, the research team anticipates that the CST-HIV has the potential to meaningfully inform HIV care in Spain, and perhaps also in other countries with similar social, cultural, epidemiological and health system contexts. Methodologically rigorous studies are needed to assess how the use of the CST-HIV affects specific dimensions of the clinical experience such as patient-provider communication, clinical decision-making, and health and HRQoL outcomes. Commonalities and differences can be observed when the CST-HIV is compared to two other short, broadly focused PROMS developed to support the clinical care of PLHIV: the Positive Outcomes PROM, developed in England and Ireland, and the Short-Form HIV Disability Questionnaire, developed in Canada. It is not known how differences among PLHIV and healthcare providers in Spain and these other settings might be reflected in differences across the CST-HIV and these other two instruments. Thus, an open question that should inform future research and practice in this area is whether one instrument or another might be a better “fit” with the self-defined needs of PLHIV and healthcare providers in other countries. In sum, the CST-HIV is a promising new tool for improving healthcare for PLHIV in Spain. Its relevance for HIV care in other countries should be explored. Researchers must engage with policy-makers and affected communities to maximise the potential for PROMs of this nature to contribute to advancing the multidimensional health and HRQoL of PLHIV, consistent with the World Health Organization’s vision of health as “a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity”. |
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