Patient-reported outcomes need to be collected from all sections of the population to prevent inequalities in healthcare, researchers say

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Greater effort is needed to ensure that patient-reported outcomes (PROs) are collected from all sections of the population to prevent inequalities in healthcare, according to UK researchers.

Experts at the University of Birmingham have found that PROs provide valuable evidence on the efficacy and safety of drugs and biologics, but their significance is diluted if they are not representative of the sex, age, ethnic background, and abilities of the people who would benefit from them.

Despite regulatory guidance and public expectations, most clinical trials failed to reflect target populations, undermining the collection of meaningful information about drug response and the impact of treatment on patients’ symptoms and quality of life, the researchers argued in an article in Nature Medicine.

According to lead author Professor Melanie Calvert, from the university’s Institute of Applied Health Research, the result of unrepresentative research can be health data poverty. ‘Targeted initiatives are needed to ensure that no groups are excluded from participation in patient-reported outcome data collection, both in research settings and routine clinical care,’ she said.

Participation barriers

The team identified barriers to universal participation in PRO data collection. These included disabilities, such as sight impairment, arthritis, or cognitive function, as well as learning disabilities and illiteracy, which could make participation ‘burdensome or challenging’. Older people, those on low incomes, and marginalised groups were more likely to experience digital exclusion as PROs move to electronic data gathering.

Minority ethnic groups, traditionally under-represented in clinical studies, also tend to harbour mistrust of research and medical institutions, according to the authors. They pointed to National Institute for Health Research Portfolio figures on cancer clinical trials, which showed that only 17% of 84 trials collecting PROs reported ethnicity data.

Making participation more equitable

The researchers made a series of recommendations for improvements. These include:

  • Improve diversity by involving individuals who represent target populations when designing patient questionnaires
  • Consider the type and severity of disease when seeking patient views, including cognitive or functional impairment that would limit participation
  • Be aware of cultural needs or languages that might be a barrier, and address these sensitively and appropriately
  • Include individuals with all levels of literacy and cognitive abilities by ensuring material is accessible
  • Provide alternative methods of participation to promote digital inclusion
  • Discuss how to ensure data collection inclusivity at the outset of designing trials for drug development.

‘When we start to embrace new approaches to healthcare, such as use of patient-reported outcomes, we need to make sure that barriers to participation are addressed at an early stage,’ said Professor Calvert. ‘If we don’t do this, the gaps between advantaged and disadvantaged populations will only get worse.’

Roger Wilson, a patient partner who co-authored the article, said: ‘Listening to patients reveals the range of diversity which must be understood and allowed for by careful design if a study is to offer benefits to society equitably.’

This article originally appeared on Medscape, part of the Professional Medscape Network.

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