Developing a patient-reported outcome measure for HIV

A team of clinicians, researchers and people living with HIV has developed a ‘patient-reported outcome measure’ (PROM) for use in HIV care – the Positive Outcomes HIV PROM. We spoke to Professor Richard Harding at King’s College London about the rigorous process used to develop the tool and how it can support clinical care by helping patients to express their needs.

Why is there a need for a patient-reported outcome measure for HIV?

People living with a health condition may have concerns, which may be medical or non-medical. People living with HIV can have all kinds of problems that can be really burdensome: physical symptoms, like pain and gastrointestinal problems or psychological problems like anxiety and depression. For example, we published a systematic review a few years ago which showed that, for people on antiretroviral therapy, the prevalence of anxiety is around 30%, which is much higher than it is for people with other long-term conditions. We know that people also have spiritual distress and we’ve done lots of work with African communities around spiritual wellbeing. We also know people experience a number of social problems, around poverty, employment, and housing. We want to take a more multi-dimensional, person-centred approach to health and wellbeing.

What’s really interesting in clinical encounters is that the person living with the condition thinks, ‘the doctor or nurse will ask me about what matters’, so they are waiting to be asked, and the clinician is thinking, ‘if there is something of major concern, the patient will tell me’. So many of those issues are never brought to the clinical encounter.

What we need is some kind of mechanism to make it clear that, within this clinical encounter, all kinds of problems are important and relevant, and we need to make sure patients are asked about them every time. By having a patient-reported outcome measure (similar to a questionnaire) that is brief, but addresses the key things that matter, you can do a full person-centred assessment every time, and the patient is enabled to identify what matters. It means you can quickly focus on what matters to this person right now, rather than going through a detailed assessment of all the things that don’t matter.

Person-centred outcome measurement is the core of what I do, and I’ve worked with people living with HIV in the UK and sub-Saharan Africa for many years. We have had great success implementing routine patient outcome measures for people living with HIV in Africa and also in other conditions such as cancer and lung disease. It’s become a matter of policy and guidance that you use these. It ensures patients are empowered to identify what matters to them, and that clinicians have rapid access to that information.

Who did you bring together to work on the PROM’s development?

This work was originally funded by the MAC AIDS Fund with a grant to the British HIV Association (BHIVA), and we received additional funding through the St Stephen’s AIDS Trust. It was a great partnership from the beginning. BHIVA partnered with UK-CAB (the UK’s network for community treatment advocates) and then approached us.

It’s been a real collaboration from the start, and we’ve had a number of people living with HIV at the core of steering group. Initially, Mark Platt and people from UK-CAB undertook consultations with community groups and then with Dr Katherine Bristowe, the steering group of people living with HIV and BHIVA, we conducted qualitative interviewing in England and Ireland.

For the work on defining the measures, we came together as a large stakeholder group including people living with HIV, researchers, clinicians, and specialists in the science of measurement. We held a half-day meeting, at which we reviewed and discussed the evidence. It was a really exciting, collaborative process.

Could you give me some examples of the range of issues the questionnaire covers?

When we analysed the interviews with people living with HIV, the main areas that were discussed were in one of six categories: physical problems, especially around pain and gastro-intestinal symptoms. Pain is an important area – it can affect your mental health, your ability to study and work, and all aspects of your wellbeing. Cognitive problems were mentioned, and issues around memory and sleep were really important.

Psychological problems, such as anxiety and depression were mentioned, as were social issues, including problems with social isolation and also intimacy. Welfare issues, for example finance and immigration were highlighted and information needs, particularly around ageing, long-term outcomes, co-morbidities and treatment decisions.

Issues around reproductive rights and reproductive health were also highlighted. What we need in the core measure are those items that are going to be most relevant to most people, but we also have to reflect key populations with specific needs. For example, people with issues around immigration, people who are thinking about parenting, people experiencing intimate partner violence. Some of these may not be common, but they are important enough that they need to be in the measure.

Could you tell me a bit about the process you went through to arrive at these measures?

To develop an outcome measure, it is absolutely crucial that you conduct that process in line with best scientific practices and psychometrics, which is the science of developing and testing health measures. The first step in psychometric work is always to look at the published scientific literature and then to conduct qualitative work to understand the range of issues that matter to the population you want to work with.

The stage where we brought everyone together to look at the evidence and agree on measures is what we call ‘item generation’. The next stage is collecting cognitive interview data- asking people living with HIV to read the questions aloud and formulate their responses, to make sure the questions make sense, everything is addressed, and to understand how people use the scoring system.

We are currently writing up our validation data, which show that the measure has reliability and validity. This is another example of how well the project has worked in terms of collaboration – the EmERGE project validated the PROM using an app with around 2500 people in five European countries.

How will the PROM work in clinical practice?

This is a very interesting area. The use of outcome measures in routine health care has been systematically reviewed in a number of papers and it does achieve benefits. By having this routine measure, you get a more detailed assessment, the patient is better able to express their needs, communication improves, you get better use of clinician time, and you improve patient-reported outcomes.

Our challenge is now about implementation science. Outcome measures only work if you use the data. If you complete the measure and put it on file, nothing happens. If you use it to guide your assessment decisions and referrals, then it works. The question is how do we get this PROM to become part of electronic patient records or routine assessment? When and where is it best completed?

We know HIV services have been severely cut back, so there are also questions about referral networks. Where do you refer someone with a long-term psychological problem or a welfare need? Ultimately, how do you make sure the data are driving better care for the person living with HIV.

If you just say, ‘the measure is ready, use it’, it may work in some places, but you can see it failing quite easily in others. What we want to do now is secure funding for proper implementation approaches, so that this can be a very clear system, with clear procedures and frameworks. We want people to be able to adopt this with confidence and make it work in practice.

The measure has been validated in five European countries – Belgium, Croatia, Portugal, Spain and the UK. The challenge now is a really successful implementation.

Find out more about the development of the PROM in a journal article by the team, published in Health and quality of life outcomes.

This eFeature appeared in the September 2020 edition of the Eurobulletin.