Development of the HIV360 International Core Set of Outcome Measures for Adults Living With HIV

A Consensus Process

João Marques-Gomes; Matthew J. Salt; Rita Pereira-Neto; Franca S. Barteldes; Vera Gouveia-Barros; Alexandre Carvalho; Antonella d'Arminio-Monforte; Alethse De-la- Torre-Rosas; Amy Harris; Catarina Esteves; Carcom Maor; Cristina Mora; Carla Oliveira; Cristina Sousa; Douglas D. Richman; Esteban Martinez; Fábio Cota-Medeiros; Filipa Gramacho; Georg M. N. Behrens; Graça Gonçalves; Helena Farinha; Isabel Nabais; Inês Vaz-Pinto; Juan Sierra-Madero; Joaquim Sousa-Gago; John Thornhill; José Vera; Maja Erceg-Tusek; Margarida Tavares; Miguel Vasconcelos; Nuno Fernandes; Nicola Gianotti; Nienke Langebeek; Paulo Anjos; Raquel Couto; Ricardo Fernandes; Reena Rajasuriar; Rosário Serrão; Shaun Watson; Teresa Branco; Tiago Teixeira; Vicente Soriano


HIV Medicine. 2022;23(6):639-649. 

In This Article

Abstract and Introduction


Objectives: HIV outcomes centre primarily around clinical markers with limited focus on patient-reported outcomes. With a global trend towards capturing the outcomes that matter most to patients, there is agreement that standardizing the definition of value in HIV care is key to their incorporation. This study aims to address the lack of routine, standardized data in HIV care.

Methods: An international working group (WG) of 37 experts and patients, and a steering group (SG) of 18 experts were convened from 14 countries. The project team (PT) identified outcomes by conducting a literature review, screening 1979 articles and reviewing the full texts of 547 of these articles. Semi-structured interviews and advisory groups were performed with the WG, SG and people living with HIV to add to the list of potentially relevant outcomes. The WG voted via a modified Delphi process – informed by six Zoom calls – to establish a core set of outcomes for use in clinical practice.

Results: From 156 identified outcomes, consensus was reached to include three patient-reported outcomes, four clinician-reported measures and one administratively reported outcome; standardized measures were included. The WG also reached agreement to measure 22 risk-adjustment variables. This outcome set can be applied to any person living with HIV aged > 18 years.

Conclusions: Adoption of the HIV360 outcome set will enable healthcare providers to record, compare and integrate standardized metrics across treatment sites to drive quality improvement in HIV care.


HIV Infection

Since the first reports on HIV/AIDS in the 1980s,[1–3] HIV has infected more than 79 million people worldwide.[4] An estimated 38 million people are currently infected with the virus[5] and HIV infection ranks sixth in terms of global years of life lost.[6]

Although people continue to get infected, the rate of new infections has decreased by 52% since the peak in 1997.[4] The effort to eliminate HIV/AIDS was driven by the 90–90–90 target; by 2020, 90% of people living with HIV (PLHIV) would know their HIV status, 90% of the people diagnosed with HIV infection would receive antiretroviral therapy (ART), and 90% of all people with HIV on ART would be virally suppressed.[7] More recently, proposals have been made regarding a 'fourth 90' – to 'ensure that 90% of people with viral load suppression have good health-related quality of life' (HRQoL).[8] Although these population-based targets are integral to understanding treatment progress for PLHIV, there is a growing call to incorporate patient-centred care into routine treatment. Patient-centred care refers to 'a partnership among practitioners, patients, and their families (which) ensures that decisions respect patients' wants, needs, and preferences, and that patients have the education and support they need to make decisions and participate in their own care, as well as participate in quality improvement efforts'.[9] This works in tandem with the 90–90–90 goals. Identifying best practices and improving the quality of care are achieved, in part, by systematically measuring outcomes at the patient level and encouraging benchmarking.[10–12]

The prognosis and life expectancy of HIV-infected individuals have improved significantly.[13,14] Between 1996 and 2013, the life expectancy of a 20-year-old patient initiating ART increased by 9.5 years on average in North America and Europe.[15] With good adherence to medication, immunological damage is minimized, and the life expectancy of HIV-positive individuals taking ART has approached that of the HIV-negative population.[7,13,16,17] Consequently, the demographics and clinical characteristics of PLHIV have changed dramatically, with a growing proportion of individuals aged over 60 years.[17–19]

With increased life expectancy, people with HIV tend to experience an earlier onset of age-associated comorbidities[20] and are at a higher risk of acquiring these conditions,[18,21,22] including cardiovascular disease,[17,23] renal and liver impairment, cancer, neurocognitive impairment[17,24] and psychiatric conditions.[18] By 2030, nearly 85% of all HIV-infected patients are expected to have to manage at least one comorbidity.[25] More significantly, 23% of patients are expected to be affected by three non-communicable diseases.[25] Furthermore, besides taking ART, these individuals will also need to adhere to additional life-long therapy.[17] Despite improved ART tolerability, potential interactions with these additional medications can occur, necessitating more frequent adjustments and monitoring amongst PLHIV.[17,25,26]

Attention should no longer focus solely on survival, but also on how overall quality of life is affected by the disease(s) in the long term.[17] The International Consortium for Health Outcomes Measurement (ICHOM) is leading the way towards the creation and adoption of core outcome sets to quantify these outcomes across a range of 40 medical conditions.[27,28] Separately, there are ongoing efforts to report the success of routine HIV care at a population level.[18,29–32] However, there is no internationally accepted, standardized approach to measuring the success of routine HIV care at the patient level. While survival and clinical outcomes are frequently collected, patient-reported quality of life is rarely measured, despite increasing recognition of its importance.[21,33,34]

The Need for a Core Outcome set

Best practices are, by definition, evidence-based and produce the best outcomes. Care providers and health professionals must rethink their best practices based on the health outcomes that address the main concerns of PLHIV from a holistic perspective, including patient-reported outcomes. Once validated across patients, the creation of a core outcome set is a solution to this; by standardizing outcomes, measures and time points, comparison of patients and providers is facilitated,[35] and additional data becomes available for treating the condition. Outcome sets should:

  1. Standardize the measurement of health outcomes (both clinical and patient-reported) of PLHIV from a holistic perspective and can improve daily clinical practice.[11]

  2. Be feasible.[36] Thus, the instrument should not be too long – it should be a core outcome set.

  3. Be globally accepted.[36] Consensus building is particularly important to ensure that care providers and HIV-related organizations are willing to measure the same indicators and learn from each other.

Once complete, the aim is to improve care through systematic care improvement cycles.[10] First, outcomes data are collected and analysed. Second, opportunities for improvement are identified. Third, an improvement plan based on these opportunities is implemented.

Measuring outcomes for every patient and improving care based on what matters to patients are major components of the value-based healthcare (VBHC) framework.[37,38] This framework aims to transform healthcare around the globe to improve value for patients, where value is defined as the ratio between the outcomes that matter to patients and the costs of achieving those outcomes.

The International Consortium for Health Outcomes Measurement has demonstrated the potential of developing core outcome sets and implementing them in lower-income contexts. Integrating the ICHOM Pregnancy and Childbirth Outcome Set in Kenya, using mobile phones to record the patient-reported outcome measures (PROMs),[39] has shown to have a positive impact on maternal and child outcomes.