Conclusion

The disappointingly low response rate was a surprise; however, we can suggest reasons for the apparent lack of interest. This additional research was developed towards the end of the main study and neither patients nor sites were expecting further involvement beyond their final 4-T visit. We also experienced long delays in local approval processes. We have no robust statistics, but many local research and development (R&D) offices took a very long time to review the documents, some requiring us to re-submit more than once. We believe these delays directly impacted on the response rate since rather than being able to send the recruitment packs to 4-T patients soon after the trial results were published in October 2009, they were eventually circulated 6–8 months later. For all patients this would have been almost 12 months after they had completed the trial; for many it would have been up to 2.5 years after their final 4-T visit. It is possible patients felt disconnected from the trial, or that the results had little relevance to them at this late stage.

Interestingly, 23 (41%) of the original 4-T centres declined to take part in this follow-on study. By the time they were asked to distribute recruitment packs, many centres had archived their 4-T files and any loyalty they may have had towards 4-T is likely to have been supplanted by newer research studies. Additionally, we received no patient questionnaires from 19 (56%) of the 34 sites who did agree to take part, and it is possible the recruitment packs were not circulated. We have no detailed statistics on reasons for site refusal but anecdotally we can report that some were reluctant to distribute recruitment packs on behalf of the research team as there was no financial recompense. The study was also ineligible for the NIHR Research Network portfolio for the same reason. While we appreciate that R&D offices have a responsibility to ensure their staff are adequately resourced, we feel that this low budget ancillary study is something that the network could have supported. With hindsight it may have been beneficial to convert the 4-T research sites to Patient Identification Centres and request permission from the National Information Governance Board for Health and Social Care to recruit via the central co-ordinating office. Had we been able to contact patients directly we may have had better representation as we would have been able to include all 577 patients in the initial recruitment phase. We would also have been able to follow-up non-responders which we were unable to do through the sites, although this is a recommended practice.5

Although we initially intended to investigate patient understanding of trial results and the preferred method of receiving end-of-trial information, the low response rate makes it difficult to extrapolate findings to the wider population. It is clear that the most of the patients who completed the questionnaire felt well informed about the trial and for the most part had a positive trial experience. This is likely to have influenced their decision to return the documents therefore care should be taken when interpreting these results.

As we found previously,3 patients clearly demonstrate appreciation for local clinical staff. Our results in table 1 suggest that although there is a cohort of patients who are not interested in the trial beyond their own treatment, the majority of patients thought receiving the results improved their trial experience. This supports the need to share the full results and not just information which will affect an individual's future care as has often been the case previously.6 Another study disseminated results via teleconference7 and this was warmly received by the press.8 We were keen to see if this would be widely received as an acceptable method for 4-T patients. It is interesting to note the lack of interest expressed compared with the coffee morning option. This may be because some patients had a previous positive experience of a 4-T coffee morning. It also may relate to the age of 4-T patients, who were on average over 10 years older than the Huntington disease patients. The Huntington patients may also have had greater levels of disability, which might constrain their choice of medium for results dissemination.

Although most patients chose at least one correct option for the trial results, when asked to describe the findings in their own words we found patients tended to focus on their individual care with over a quarter describing personal improvements in diabetes control. This correlates with the reasons why patients entered the trial (table 3), is consistent with other research,9 ,10 and indicates that the purpose of clinical research is not well understood by the public. We suggest this should be better communicated at the outset, and then reinforced throughout the trial process.

Communication of scientific research to lay audiences is a priority for both academic and political communities. Scientific scepticism is common in developed nations, yet only 25% of European and American public are considered ‘scientifically literate’.11 Researchers have a responsibility to report their work and the Canadian Health Services Research Foundation recommends that when considering dissemination, information is ‘clear, simple … tailored for each audience based on knowledge user need’.12 It is a requirement that trials registered with ClinicalTrials.gov publish in the public domain, and 4-T results are available via this website. We postulate however that the ClinicalTrials.gov template does not encourage lay review.

The 4-T model of providing results to participants via a social event was well received by patients and sites and shows promise as a method of sharing information. We believe this study illustrates that results dissemination plans should occur alongside protocol development forming part of the overall study and included in reimbursement calculations. We have perhaps also shown that interest in studies quickly wanes for both patients and centre staff so any dissemination is likely to be needed rapidly if it is to have any impact at all. It remains to be seen if the interactive opportunities offered by local coffee mornings would lead to greater understanding of research in general.