News & Activities
Methodology Monday March Roundup
Five interesting articles were included in the 2nd month of our Methodology Monday campaign. They include a focus on the use of technology (digital trials, decentralised trials), and a couple of literature reviews with recommendations to overcome identified barriers and highlight the lack of inclusion of persons with disabilities.
The first article is codeveloped by patients, members of the public, clinical staff and researchers: Encouraging Inclusivity in Technology Clinical Trials. It looks at making digital trials more inclusive. Digital trials are designed to assess digital technology (e.g. devices or mobile applications) to develop new technology-enabled healthcare pathways. It is hoped this will ultimately continue to enhance the accessibility of healthcare for patients, with reduced intensity of hospital attendance. Consulting with a limited number of people from a demographically homogenous proportion of the population means that many voices with valuable experiential expertise are not able to inform the research. It is incumbent on the team to ensure that patients as ‘co-researchers’ means all patients, inclusive of all protected characteristics. Read this guidance, co-developed by patients, members of the public, clinical staff and researchers.
A new article from our team. Persons with disabilities are amongst the vulnerable in our population and are often excluded from clinical trials. We assessed more than 400 trial reports to see if they included people with disabilities for diversity monitoring purposes. Sadly, none did. This is not good enough and needs to be improved. Our article will hopefully instigate change.
This is a rapid review of the literature to identify barriers to inclusion and strategies to improve it. The main barriers identified were language and communication, lack of trust, access to trials, eligibility criteria, attitudes and beliefs, lack of knowledge around clinical trials, and logistical and practical issues. Many of the barriers relating to inclusion are the same as those that impact trial design and healthcare delivery generally. The authors make 15 practical recommendations for change.
How do decentralized trials support hashtag#DEI? In this article, the authors compare and contrast the processes involved in traditional randomised clinical trials and newer decentralised clinical trials; considering the pros and cons with respect to accessibility, equity, and scientific effectiveness; and discuss areas for further improvement.
Digital trials potentially enhance inclusivity by facilitating trial participation, as remote interventions can provide access to underserved groups. The aim of this article is to highlight and reflect upon study design decisions that might unintentionally enhance inequities in digital interventions across key research stages - recruitment, enrolment, engagement, efficacy/effectiveness, and retention.
