A stated aim of the programme was to develop an NHS pathway for the management of CC in adults based on data synthesis. Specifically, we stated that ‘findings will be assimilated and synthesised with previous research, and a national working group convened to develop a new treatment pathway for management of CC in adults’. To this end each participant had a unique ID so that they could be followed through each of the trials. Considerable under-recruitment, reflecting the difficulties of recruiting the patient population, severely limited the scope for an integrated analysis or pathway. However, with all the caveats noted, evidence from the CapaCiTY trials supports the value of standard-care habit training and high-volume TAI and questions the value of habit-training with biofeedback, INVEST procedures and low-volume TAI. The findings as they pertain to lapVMR are mixed and lend some support to this procedure in a highly defined population with informed consent.
With these conclusions in mind, provides a revision of the pathway schematic presented in SYNOPSIS. Here, patients receive a standardised intervention with habit training, and only if this fails do they progress to INVEST. Thence, selected patients with the specific diagnosis of dyssynergic defaecation can undergo direct visual biofeedback, and others can undergo TAI, this being initiated by default with a high-volume device. Patients progressing to a MDT meeting for consideration of surgery may be offered lapVMR if they meet the strict selection criteria, but the consent process must include realistic data on the immediate and longer-term benefits (or otherwise) of this procedure, noting that enhanced consent procedures with standardised proformas and patient information leaflets (provided by the Pelvic Floor Society) are already best practice in relation to detailing long-term harms. Surgeons could, for instance, cite a conservative interpretation of our data in relation to reduced bowel symptoms but falling overall satisfaction with surgery over time, as well as little or no improvement in general QoL.
Revised prototype pathways of care informed by results of the CapaCiTY research programme. a, Alarm features excluded and secondary causes treated appropriately; b, in IBS-C, consider antispasmodics or neuromodulators in case constipation improves but (more...)
Reflections on the whole research programme and overall conclusions
How will the international community receive such a pathway? We feel that the answer to this in the UK is with general positivity. Over the 6 years that the CapaCiTY research programme has run, from initial meetings at national society conferences to the present, we have witnessed hugely positive engagement from experts in the field through to more general audiences. Our ability to bring together the specialist community, both specialists whose centres recruited and specialists whose centres were unable, has proved a major triumph of the programme. Although this is not measurable in adequately powered clinical-effectiveness data, it can be inferred by how many units have standardised their approach to diagnostics and therapy by education through the programme. Furthermore, conclusions from our systematic reviews have already entered major textbooks and have received national and international platforms for presentation. Dissemination activity is ongoing, and there is no doubt that we will be invited for national and international presentation of the conclusions of the three CapaCiTY trials. These ‘softer’ end points will be the main enduring legacy of the CapaCiTY research programme and the lives of people living with CC will be the better for it.
Lessons learned for future research
The considerable challenges to recruitment for all three trials have been noted. outlines some insights about how these problems might be mitigated in the future.
Lessons learned for future research
Patient and public involvement
Patient representation in the CapaCiTY research programme supported all research activities. The focus of the CapaCiTY research programme from a PPI perspective was to convene a Constipation Research Advisory Group (CRAG) comprising eight patients and two carers from London, UK, and Durham, UK. This group had geographical diversity (covering both north and south England) and a disease-appropriate demographic (eight female and two male participants). PPI was managed by two co-applicants and the CRAG had an active ‘contributory’ rather than ‘representative’ role. The overarching functions of the CRAG included:
managing the research (e.g. steering/advisory group)
developing participant information resources
advising on protocol revisions (in particular on recruitment and participant burden)
disseminating of research findings.
Although CRAG members had patient knowledge of living with severe CC, they did not have the same knowledge of clinical trial and medical research terminology as the research team. Because CRAG members were invited (in rotation) to sit on the Programme Steering Committee (PSC), this put them at a disadvantage. Therefore, training was provided to CRAG members at the start of the project in 2015 that included taking part in an activity in identifying barriers to recruitment in clinical trials and potential solutions. This enabled the CRAG members to review all patient-facing documents including the patient information sheet, patient diaries and patient journals at the beginning of the programme for all three trials. It also enabled them to feel more comfortable when they attended a PSC meeting.
The CRAG was actively involved and effective in providing lay advice and guidance in areas of trial feasibility, design, management, marketing, analysis, recruitment and reporting. Furthermore, CRAG members reviewed all patient-facing material during the substantial amendment in 2016. The CRAG was also consulted about reducing the length of follow-up from 24 to 12 months.
The CRAG reported and made recommendations to the PSC. It was agreed that normally CRAG meetings would be held every 6 months prior to the PSC (ideally 1 month before). The CRAG would feed recommendations back to the PSC. Therefore, the CRAG had a significant role in strategic decision-making. For example, in 2017 the CRAG was provided with a detailed presentation as per the PSC’s recommendation. The PSC asked that the CRAG answer whether or not the CRAG deemed CapaCiTY trial 2 futile owing to under-recruitment. Although it was noted that the inclination of the PSC was to continue, they were keen to consult with the CRAG. The group discussed at length the key areas under consideration, which included the following: was it safe for the patients participating in the trial? Was it cost-effective to continue? Would the research questions be answered?
Though the group accepted that, ideally, more patients should be recruited to improve the accuracy and validity of the data results, it was generally agreed that 100 patients was an acceptable milestone.
The CRAG also discussed financial matters. However, the main focus of the in-depth discussion was whether or not the research questions would be answered. Owing to the smaller sample size it was recognised that the primary research question could be compromised. However, the CRAG recognised the importance of being able to answer many other questions in relation to high-volume and low-volume TAI treatments. The CRAG discussed the value and importance of the secondary data that had been captured to date and data that would continue to be collected if the trial was to continue. It was evident that from a patient perspective these data were of significance. It was noted that the CRAG wished to avoid any negative messaging and in particular did not wish to put off future patients from entering a trial because of the possibility of cancellation.
This consultative approach between the PSC and CRAG, seeking to direct and support the three trials, ensured that both researchers and patients had a mutual understanding of what was required. This ensured that the findings of the three trials would be of benefit to participants in those clinical trials. In addition, three members of the CRAG held a teleconference with Christine Norton and Shiva Taheri to contribute to the interpretation of the interview data and to agree and support the main messages for dissemination.
Overall, patient representation made a major contribution to design, conduct and recruitment of the CapaCiTY research programme. The CRAG was involved in all major decisions that were made during the programme, which meant that patient benefit was always put first in everything we did. The CRAG will continue to support the CapaCiTY research programme in dissemination activities, including at the Bowel Research UK annual Big Bowel Event.
