A psychological intervention for suicide applied to patents with psychosis: the CARMS trial (Cognitive AppRoaches to coMbatting Suicidality)
The CARMS project is funded by the Efficacy and Mechanism Evaluation (EME) Programme, an MRC and NIHR partnership, 13/161/25.
*The EME Programme is funded by the MRC and NIHR, with contributions from the CSO in Scotland and NISCHR in Wales and the HSC R&D Division, Public Health Agency in Northern Ireland.
The Research Design Service (RDS) provides free research design and methodological advice to people intending to apply for national peer reviewed funding competitions in applied health and social care research. Many of these funding programmes have a two stage application process, whereby the applicant completes an outline of their application for stage one. This is then reviewed by the funding panel and if accepted the applicant is invited to apply to stage two, the full proposal stage. The RDS is able to provide advice on either stage one applications or stage two or both if required. One funding programme that has a two stage application process is the EME Programme.
The NIHR Research Design Service North West (RDS NW) was approached by Dr Patricia Gooding, University of Manchester, regarding the CARMS project. Dr Gooding had already submitted and been successful at stage one of EME and had been invited to submit a stage two application. She had not thought of involving RDS before, at stage one, and was initially a little sceptical about what the RDS could offer, but she was encouraged to contact RDS NW by a senior RDS NW adviser, who was a colleague at the same organisation.
The RDS NW arranged an initial face-to-face meeting with the client. The meeting was arranged by the Dr Gooding’s RDS NW case manager, an RDS NW adviser who ensures that the clients receive all the possible advice that is required to improve the chances of success. Advice may be provided directly by the case manager or they may arrange for a number of other RDS NW advisers to provide advice based on the specific areas of expertise required. In the case of this application, the case manager provided the advice that was required with an additional critical read from another RDS NW adviser.
At the initial face-to-face meeting, the case manager and the Dr Gooding looked closely at the stage one reviews, which are carried out by the funding programmes peer reviewers. They looked at the funding panel’s feed-back. This enabled discussion to address specific points raised in the reviews and panel’s feedback which needed to be considered for the stage two application. Some specific points that came about as a result of this discussion include:
• For an EME application the applicant needs to make it clear that the primary outcome, in this case suicide ideation, is an efficacy rather than an effectiveness outcome.
• EME is very interested in exploration of mechanism so it is better to model the influence of the mechanisms on the outcome, It was suggested to the client that they think about whether it is possible to power the study for mechanism evaluation, as well as for the effect on the primary outcome.
• A clear description of what the intervention is, and its rationale was needed.
• The client needed to state clearly what the population size is, and how that translates in to the study recruitment.
• EME likes to see a partnership of at least two of NHS, university and industry organisations, so it would be good to strengthen this for this application.
As part of the RDS NW advice process continuous review is offered of draft proposals.
In this instance the case manager reviewed and commented on the proposal but prior to submission of the application, the RDS NW case manager arranged for another RDS NW adviser to provide a critical read. This was carried out by an RDS NW adviser with qualitative methods expertise, to provide an alternative viewpoint of the application, particularly its qualitative aspects.
This critical read of the application, shortly before submission, showed that following RDS NW advice the proposal was very readable and much clearer than the stage one application. Overall the proposal conveyed the rationale for the study very strongly and it was thought that the model and treatment was really interesting but it was also thought that the proposal needed to be more explicit about the relevance to EME. There was a need to emphasise, in this case, where better understanding of the mechanisms responsible is necessary and valuable for treatment effectiveness. There was also a need to make clearer how the qualitative work contributes.
Comments were passed to Dr Gooding and the proposal was submitted for the stage two deadline enabling Dr Gooding to receive a conditional offer of funding. The conditional offer asked questions relating to the collection of health economics data on the project. These questions needed to be addressed before funding would formally be offered.
Dr Gooding again approached the RDS NW asking for advice on how to address this issue. The case manager reviewed the conditional offer letter from EME with the Dr Gooding, enabling them to interpret what was required and address the issues raised by the EME funding panel. As a result the client successfully received funding for the project.
Here are a few words from Dr Gooding on her experience of working with the RDS NW:
“So many thanks for all your help with it. It really improved hugely as a result of your input”
“As we had two experienced advisers, the service was absolutely brilliant.”