Patient and public involvement

What form did the patient and public involvement take and at what stages did it occur during your study?

• Former TB patients and caregivers were members of our IDG and were actively involved in interpreting synthesised data and in shaping design of intervention components. This included regular face to face meetings, with preparatory calls to ensure that they had all of the information needed to take part to their satisfaction in the group meetings and when feeding-back their views. They were also kept informed of the study, and the results were formally presented to them both face to face and online.
• Tuberculosis alert, at the time the UK’s largest charity focused on TB, were involved from the outset in the conceptualisation and development of the study. With their focus on working with vulnerable communities they were able to provide key insights into the lived experience of people taking treatment for TB. They also helped to support people affected by TB who were part of our IDG; and advised on our dissemination programme to affected communities as well as TB services. Also, a charity representative and a former patient who is a member of the TB Action Group (patient advocate group facilitated by TB alert) contributed to the qualitative study design and provided input into the planned development of the manualised intervention, as well as the pilot study.
• The specialist outreach Find and Treat Service, currently based at University College London Hospital and who work with the NHS and third-sector front line services in particular in the management of TB as it affects vulnerable populations including the homeless, drug or alcohol misusers, disadvantaged migrants and ex-prisoners, were also involved from the start of the study through intervention development and assessment, to the analysis of results and their dissemination
• As part of the formative work, we interviewed 18 patients and four carers – although these were technically study participants (and as such gave their written informed consent to participate), their views and suggestions helped shape the design of intervention components and their delivery.

What impact did patient and public involvement have during the study? How was it useful?

• Patient input was critical to this study’s success – the intervention was developed with the intention of better supporting people taking treatment for TB.
• At each iteration of development, intervention materials were reviewed by patients, caregivers, and HCPs of various cadres, including senior nurses. This was done both in a structured way (i.e. via the IDG) and an opportunistic manner (e.g. in conversation with other investigators, many of whom are front-line clinicians).
• Their feedback has helped shape our conclusions and approach to future work for example a large, multicentre cluster-randomised study where consent might be at the level of the treatment site rather than the individual receiving care there; and that assessments of adherence and possible change in patient behaviour and knowledge should be less intrusive and simpler for the patient (e.g. less questionnaires, different adherence measuring device), making it easier to determine the efficacy of the intervention itself compared to standard care.
• The views and experiences of the ‘end users’ of this technology (i.e. patients and CMs) were sought again during the process evaluation, data from which have heavily influenced the recommendations made in this report around care, training, and research.

How did/will patient and public involvement support dissemination of results?

• We held a number of stakeholder meetings across North Central and North East London, as well one with the Project Oversight Group (which included two people affected by TB). These helped us formulate a dissemination strategy that recommended publicising the intervention and the results of this study but being careful to not distribute the intervention components at this stage. This was in part because of the potential definitive multicentre study that would compare these elements to standard care – and hence there had to be minimal chance they were already being used by TB services as part of their standard care package.
• Unfortunately, TB alert was very affected by the COVID pandemic and had to severely curtail its operations in the UK to maintain focus on its international work. As a result, our intended joint dissemination work was limited to presentations at TB service delivery boards where the audience mainly comprised TB and public health services and commissioners with few members of the public or patients attending. We plan to review the mechanisms for dissemination once we have submitted the final report, developed the manuscript describing the pilot study, and reviewed the feasibility of taking the intervention forward within a large, national study.