Dr Joseph Lanario is a Research Fellow at the University of Plymouth Faculty of Health and at the University of Birmingham’s Department of Applied Health Research. Dr Lanario specializes in developing patient-reported outcome (PRO) tools that capture the real-world impact of respiratory disease. He co-authored the Severe Asthma Questionnaire (SAQ) and the General Symptom Questionnaire-65 (GSQ-65), addressing the limitations of previous quality-of-life measures, created before severe asthma was recognized as a distinct condition and before targeted biologic therapies became available.^1,2

Dr Lanario is currently working on a study funded by the University of Birmingham’s Biomedical Research Centre (BRC), entitled “Inclusive Patient Reported Outcome (PRO)”, which investigates barriers to providing questionnaire data, from digital exclusion to disability. Although the project is not focused specifically on respiratory health, the lessons learned make his respiratory research more representative and clinically relevant.

The SAQ is now part of the Core Outcome Measures for Severe Asthma (COMSA) in both adults and children, positioning his work at the forefront of patient-centred respiratory care.³

To start, I’ve worked with some really passionate and exciting people. It’s very easy to persist with work like this when you work with such supportive colleagues, such as Dr Matthew Masoli at the Royal Devon Hospital in Exeter, formerly at Derriford Hospital in Plymouth, where I met him, and Professor Michael Hyland and Professor Rupert Jones, my old line manager, from Plymouth University. They all were very patient-centred and really cared about advocating for patients. That’s really where it became clear to me – there is a need to capture patient perspectives in a reliable and standardized way, which is why I co-authored the SAQ and the GSQ-65.

In particular with the SAQ; the quality-of-life questionnaires used in severe asthma were all developed over 30 years ago, the Asthma Quality of Life Questionnaire (AQLQ) came out in 1992 and the Saint George’s Respiratory Questionnaire, 1991. This was before we had a clear understanding of how distinct severe asthma is, distinct to mild-to-moderate asthma and before we had specific treatments for severe asthma, such as the monoclonal antibody drugs we use now. So there is a clear need for a specific, severe asthma, health-related, quality-of-life questionnaire to measure the true burden of disease and also the true benefits of treatment.

If we know how patients are feeling, we know how far they’ve got to improve, but it’s also about getting people to use these questionnaires. It’s about carrying out research which gives patients the confidence to fill out these questionnaires from their perspective, but also gives health care professionals confidence that they can trust what the questionnaires are telling them.

It’s key to involve patients at every step of the research process; it almost becomes a self fulfilling prophecy – if you involve patients early on, it becomes easier to keep them engaged and involved. I need to give thanks to the European Lung Foundation’s asthma patient advisory group (PAG), they have advised on a lot of the studies I’ve been involved in and created over the last few years.

By bringing research to patients early, whether it’s a research idea or methodology, they will very quickly tell you if you’re going down the wrong route. They will give advice on avoiding questionnaire fatigue and burden, for example, it’s very easy to give patients too many questionnaires or to not space them out enough. They will also help with the dissemination of results so it appeals to patients, in the main article and also in lay summaries. That’s all been incredibly helpful and has been guided by groups like the patient advisory group. We’ve also had patients who have sat in as patient members of steering committees, and they’ve advocated for the SAQ, which has been very helpful.

I’ve always been mindful that research like mine is limited if health care professionals do not use the questionnaires, either because they aren’t aware of the questionnaires, they don’t know how to use them, if they’re lacking the confidence to use them or if they are lacking confidence in the questionnaire itself. There are also examples where patients may be uncomfortable or unable to complete a questionnaire, for example, if they don’t trust the research process, they don’t trust the researchers, or if they don’t trust health care professionals.

Being unable to complete a questionnaire can also be a result of disabilities, whether that’s arthritis making it difficult to use a pen or even complete a questionnaire on a tablet, or visual impairment making it difficult to see the questionnaire. So the aim of this inclusive PRO study is to understand the barriers to questionnaire data collection, understand them in detail, and then address the barriers and improve the representation of all groups in questionnaire data. I am hoping to apply what we learned from the inclusive PRO study to my severe asthma research going forward.

Apps are heavily used now to collect questionnaire data from patients, and the results from those are being used typically in clinical practice to judge whether a patient has responded to the drugs or not. It’s really nice to see this being implemented into clinical practice, but my concern is that there will be sections of society who may not feel comfortable providing that data or who are unable to provide that data, resulting in their voices being missed. That’s a real problem, because the results will be generalized to certain groups unfairly.

That may also be the case for paper questionnaires, but you can imagine where some people in society may feel uncomfortable completing questionnaires in electronic format. If we can address that, we can ensure that those views are captured in the data and that the patient is responding to these drugs from their perspective.

More broadly, you can also see this impacting clinical trials, there is a huge push now to use the same technology to capture data in clinical trials. But these are large studies where they’ve got clear scope and resources to address barriers to the collection of such data.

We were very lucky to have the SAQ included in the Core Outcome Measures for Severe Asthma (COMSA).³ We’re included in both the COMSA’s for paediatric and adult severe asthma, and they’re currently creating a paediatric version of the SAQ (PSAQ), which it’s quite nice to see that another group has run with our original questionnaire. The concept of the COMSA was published by Dr Kate Khaleva and overseen by Professor Graham Roberts at the University of Southampton.⁴

More recently, the SAQ was included in a composite measure called the CoNFiRM score; this creates a score for assessing how well a patient is improving on treatments, predominantly biologics.⁵ It should be rolled out in clinical practice and provide a way of capturing patient-centred data, alongside the routinely captured objective clinical outcomes, such as lung function, exacerbations and reliance on corticosteroids. If you put the SAQ and the asthma control questionnaire alongside that, you get a more rounded picture of what’s going on with the patient, ensuring that their views are represented.

When I initially started this job, I was young and naïve and I thought that if there was a requirement for a severe asthma questionnaire, that we would create it and that it would get used. However, it’s clear that there are barriers to getting new questionnaires used because of a lack of confidence in them.

Further barriers include comparing new questionnaire scores to those from old questionnaires used in previously conducted trials. Integrating new questionnaires into national and international registries also poses challenges, as registries already use older questionnaires, and making updates incurs additional costs for stakeholders.

More recently, I’ve become aware that not all patients are comfortable completing questionnaires, and I think that really does need to be a focus going forward. It has been assumed that apps are going to solve everyone’s problems when it comes to the collection of questionnaire data, and it’s really not the case. We already know that there are health disparities with accessing care, but even when patients get their foot in the door, are there further barriers to them providing the questionnaire data? Looking forward, I think that’s the direction my research will go in.

References

1. Hyland ME, Jones RC, Lanario JW, Masoli M. The construction and validation of the Severe Asthma Questionnaire. Eur Respir J. 2018;52:1800618.
2.  de Felice G, Hyland ME, Lanario JW, et al. Preliminary development of a questionnaire to measure the extra-pulmonary symptoms of severe asthma. BMC Pulm Med. 2021;21:369.
3. Khaleva E, Rattu A, Brightling C, et al. Development of Core Outcome Measures sets for paediatric and adult Severe Asthma (COMSA). Eur Respir J. 2023;61:2200606.
4. Rattu A, Easton S, Coleman C, et al. Developing a quality of life outcome measure for paediatric severe asthma: a field-testing survey. Eur Respir J. 2024;64(Suppl. 68):PA1327.
5. Khaleva E, Brightling C, Eiwegger T, et al. CONFiRM score – CompOsite iNdexes For Response in asthMa Patient-centred composite scores as tools for assessment of response to biological therapy for paediatric and adult severe asthma. Eur Respir J. 2025;65:2400691.