Equality, diversity and inclusion

How have you used language and terminology to make the research inclusive? What principles have you taken in your approach to enable inclusivity and why?

• We aimed to avoid dehumanising language, following international guidance101
• We included an ‘other’ option when asking participants to self-identify their gender

What were the characteristics/demographics of the population which your research looked to serve?

• While we wanted to develop an intervention that would apply to all adults starting treatment for TB disease, our target populations were those where adherence to several months of drug therapy may be particularly difficult through social or personal factors.

Did the target of research (disease, disorder or intervention) impact or affect different groups in a different way? What data did you review to investigate this?

• We identified no evidence to suggest that particular groups of patients found the intervention to be more or less helpful than others. However, there was a suggestion that some components of the intervention (e.g. the booklet compared to the educational videos) were more popular with some participants than others.
• It was difficult to recruit people at potentially greatest risk of non-adherence, which may explain why we saw a degree of uniformity in our results (including high levels of adherence).

Do the existing preventative, screening or diagnostic strategies and treatments impact or affect different groups in a different way? What data did you review to investigate this?

• The current standard of care is to perform a risk assessment for several factors that are regarded as being strongly associated with non-adherence and non-completion of treatment (namely drug or alcohol misuse, homelessness, history of incarceration, mental health issues and migrant status). If these are identified, then increased care and support are offered.
• The process misses some other factors that our formative work suggested were also important, plus it relies on staff to have a standard approach to assessments (which local evaluation through the TB treatment Cohort Review suggests may not be the case) as well as knowledge of what support services are available for patients who are identified as being at risk of non-adherence.
• This means that there is considerable potential for patients needing specific support to be missed; in particular, those likely to default but without the ‘standard’ risk factors for this.

Describe the generalisability/transferability of evidence on safety and effectiveness across the population groups considered in the study design and study population, end points, expected geographic location of trials/studies, language or literacy considerations for resources and research team.

• It is difficult to talk about generalisability in strict terms as many aspects of our intervention were highly context-dependent. This is partly by design, with the intention of making the package adaptable to a variety of settings.
• Many of this study’s findings are relevant to urban (and other) settings around the UK and in other high-income, low TB incidence countries.
• There are lessons here also for countries that are currently high TB burden.

What evidence do you have that your intervention is feasible and accessible to a broad range of patients in the populations that your research seeks to serve?

• The process evaluation indicated that it was popular with both patients and staff (though would need ongoing training and support to ensure it is used as intended throughout treatment). The study assessed it over 24 weeks of treatment.
• New regimens appear to be effective for many patients with DS TB and last only 17 weeks. This shorter duration may reduce the amount of support required during treatment. We piloted our intervention in a small number of non-English speakers. This appeared to work reasonably well though it needs to be tested across more than four languages (i.e. Bengali, English, Hindi, and Romanian)

Reflect on the important population characteristics for your study. What active steps were taken to optimise participation, retention of relevant people/groups and sustained community engagement (e.g. community advisory boards and navigators, community health workers, patient advocacy groups, local healthcare providers, etc.)?

• We held pre-study roadshows with participating centres.
• We involved TB stakeholders in study design and throughout the study.
• Based on the (informal) feedback of our first study participants, we reduced the number of study questionnaires (i.e. not those that were part of the intervention but those designed to measure its effect), which were causing early study fatigue.

What were your inclusion/exclusion criteria to enable your trial population to match the population that you aim to serve?

• For the formative research, we selected TB services that were both geographically dispersed (in Southern England, London and Scotland) and had different patient populations with TB.
• In the pilot CRCT, we had minimal exclusion criteria beyond age under 18, severe illness meaning that the patient was felt to be unlikely to survive for the duration of the study, and (most importantly) unable to speak any of the languages we used within the pilot (Bengali, English, Hindi and Romanian). The latter is important as it meant we were unable to approach around 20% of potentially eligible patients.

Was the participant population inclusive? Explain further: what worked well? What (if any) were the specific barriers to inclusion? What were the underlying causes of these barriers? What action(s) were taken to overcome these barriers? How could this be addressed in future research?

• The pilot cluster RCT required a high degree of involvement from NHS staff working in the busy TB services where the piloting of the intervention took place. During the pilot, it became apparent that the staff required training and support throughout the study to retain interest in it and hence to identify participants to take part, as well as support those on treatment to the same extent as at the start of a patient’s treatment.
• The intervention itself took longer to deliver than standard care assessments, however it was popular with both participants and staff. The assessments we used to evaluate the intervention were seen as an issue that discouraged ongoing involvement and led to dropout from the study. As such in future work, we would keep the number of assessments (of the intervention) to a minimum, plus develop more streamlined approaches to measuring adherence using the evriMED box. An example would be web-enabled recording of box-opening rather than requiring patients to bring their box each time to clinic.

How did you reduce burden on participants related to trial/study design/conduct (e.g. number/frequency of study-related procedures, use of local laboratory/imaging, telehealth, consideration of language, literacy, accessibility, transport, community engagement)?

• We shortened number and size of questionnaires, although this meant that we lost some external validity, particularly for the psychological assessments.

How have you made sure text and pictures used as part of participant and public engagement were inclusive and accessible and not discouraging to under-represented groups?

• Yes – we used inclusive language and imaging. Direct quotes from participants were used as much as possible.

What metrics did you use to ensure that diverse participants enrolment goals are achieved? Specify actions implemented during the conduct of the trial(s) or studies if planned enrolment goals were not met?

• At one site in the pilot RCT, there was an issue with recruitment. We addressed this by providing extra support to the clinics, being flexible in our approach when we would see patients for the study and encouraging dialogue. This proved to be successful, and we reached our recruitment target for that site.

Who were the underserved groups within your delivery area? (E.g. geographical or disease area that the delivery team operates in)

• The proportion of pilot trial participants with ‘social risk factors’ was lower in our sample than at national level, but was still non-negligible, at 1.3% for alcohol problems, drug misuse, and homelessness, and 3.8% for migrant status.

Have you disaggregated your data (evidence collected) to investigate any differences in the target of research on any of these groups?

• This was a pilot and feasibility study, and we did not disaggregate our data.

Does your research team include those from groups who are generally under-represented in your field of study? If not, please state why this is the case.

• Yes, we developed the study with people who had lived experience of TB (including severe long-term complications from the disease as well as the medication used to treat it), and were non-UK born.
• Our on the ground research team was led by nurses. In a future study, we would look to expand in particular the input from people and communities affected by TB so as to make the intervention acceptable to the greatest number of people being treated for TB in the NHS.

Was there a range of experience and expertise across the research team?

• Yes, the research team included clinicians, public health, behavioural and social scientists, health economists, trialists and statisticians as well as patient and stakeholder advisors with a range of experience in TB and research.
• How were development opportunities provided, particularly for more junior members of the team?
• Regular study review meetings were led by the more junior members of the team. They were also encouraged to present to external groups such as the Project Oversight Group, and at stakeholder meetings as well as scientific conferences. This was done with senior support and mentoring.
• One of the research team was inspired by the work to enrol for a higher degree, which she successfully completed in 2023. She now plans to continue in academia.

Were participants and members of the public involved representative of the disease and geographic areas? What role/s did they provide and how did they benefit the project?

• Yes, in part. The wide diversity of groups affected by TB in the UK meant that we were constrained to some extent by resoure, and hacd to focus on running the pilot RCT in London. However, we chose different geographical locations for our formative work as described above, and the populations in the pilot RCT were drawn from large TB clinics with patients from a variety of backgrounds. Historically it has been extremely difficult to get people with TB to engage with research once treated. However, we were able to identify a number of patients and their carers who were keen to be involved, for example, on the Intervention Development and Project Oversight Groups. Their insights were crucial in ensuring that we retained a focus on the importance of the study, not least during the COVID pandemic when all non-COVID research was being shut down; and hence managed to continue recruitment throughout lockdowns.