Table 3.
Open question responses coded by domain and grouped according to specific beliefs
| Domains | Specific belief | Illustrating quotes |
| Knowledge | Lack of clarity about what the task entails | “[What would help me involve PPP in numerical aspects of trials is…] Understanding what involving patients and public in numerical aspects of trials actually means, how it can be done and why it’s important.” (TM, NI) |
| ”I think the main issue here is that there are very simple parts of numerical aspects of trials which we would always, and easily, involve PPI in: outcome measure acceptability and monitoring trial progress. I don’t know what other aspects might be, so I am imagining a training or knowledge failure on my part.” (TM, involves) | ||
| Training | “[What would help me involve PPP in numerical aspects is…] training courses/workshops for members of the public on the numerical aspects of trials and also researchers on how to involve them.” (HE, NI) | |
| “This is something that has never really been discussed at work. Nor have I seen any courses about doing this. More guidance is available about writing simply for patients but not specifically about numerical aspects. Some training would be welcome.” (TM, involves) | ||
| Knowledge of patient and public partners | “[What makes involving PPP in numerical aspects hard is…] Being confident patients have sufficient understanding to be able to contribute. Not sure what could make it easier, just need to be aware this may be a potential issue during initial discussions with focus group members for example.” (TM, involves) | |
| “[What makes involving PPP in numerical aspects hard is…] a general lack of awareness of how trials (and research) work, which makes the initial engagement harder. It’s perfectly possible to overcome this though.” (Qualitative researcher, involves) | ||
| Skills | Skills of patient and public partners | “…I would suggest that if you want to involve PPI in this [numerical] aspect then you would have to purposively approach PPI with a certain skill set or advertise for such PPI involvement.” (Coinvestigator, NI) |
| “It generally quite boring for the general public and they do need a basic level of numeracy and appreciation of research methods.” (Statistician, involves) | ||
| Social/professional role | Professional role | “The grant applicants and senior team often take these decisions during trial design. I never had any impact on these decisions previously.” (Qualitative researcher, involves) |
| “Numerical roles already ‘assigned’ to statisticians and clinicians, so as Trial Manager, it can be difficult to enforce PPI involvement.” (TM, involves) | ||
| Beliefs about capability | Capabilities of patient and public partners | “Often numerical aspects are dictated by statistical programs and I think there is a general feeling that patient or public partners cannot grasp them.” (TM, NI) |
| “[A barrier to involve PPP in numerical aspects of trials is…] The PP themselves not being confident enough to comment.” (Coinvestigator, involves) | ||
| Beliefs about consequences | Impact on trial quality | “Patients can help you work out how to disseminate the results for example, which graphs are easiest, which format of presenting an estimate (risk, number of days etc).” (Statistician, involves) |
| “Discussing numerical information to patients helps to distill complex findings into something more simple and acceptable. This helps the researcher to clearer think through what are the results, helps explain information clearly that improves the quality of the trial and will ultimately all benefit the patient.” (TM, involves) | ||
| Positive impact on patient and public partners | “The PPP can … increase their knowledge and understanding of their condition, new potential treatments, and the process involved in trials which evaluate treatments. This could reduce the information asymmetry between the patient and clinician in the future.” (HE, involves) | |
| “Patients can understand the difficulties in running clinical research and trials. Showing recruitment figures and follow-up data is also beneficial as patients can see the results accumulating and the benefits of taking part in trials.” (TM, involves) | ||
| Negative impact on patient and public partners | ”Makes participation stressful, unless the PP has pre-existing skills in stats or maths.” (Coinvestigator, involves) | |
| Extra work/responsibilities for the researcher | “It is more work for the researcher to involve patients/partners.” (Statistician, NI) | |
| Uncertainty about impact on trial quality | “I think it could improve transparency of decision making through a trial process. I am less sure that will actually translate into ‘better’ decisions.” (CI, involves) | |
| “I have answered no impact because I think it is unclear whether quality or the patient partner will get a positive impact. That is a question that needs investigation.” (CI, involves) | ||
| Reinforcement | Lack of incentives | “Having some tangible reward for your investment! It never does anything for your career, while other priorities do.” (Statistician, involves) |
| “It’s not really rewarded or recognised because it is an expected part of study design. All funders we work with consider PPI involvement with trials in general essential.” (TM and statistician, involves) | ||
| Environmental context and resources | Funding | “[What would help me involve PPP in numerical aspects is…] More funding for a PPI expert at our CTU. I am only funded 10% to be the coordinator for all PPI and to do a good job, I’d like to be able to spend more time on my PPI role.” (TM, involves) |
| Time | “I will need training to effectively include the public and the public will need training to effectively contribute to the research. This will take more time and resources that aren’t currently provided but if they were this would make it much easier.” (HE, NI) | |
| Staff | “[What would help me involve PPP in numerical aspects is…] More money, more trained help. The usual problems.” (TM, involves) | |
| “[What would help me involve PPP in numerical aspects is…] Having a special person dedicated to running PPI work across trials.” (TM, involves) | ||
| Difficulty accessing willing volunteers | “It’s difficult to find public partners for any research, but when it’s something that’s specifically numerical I think that’s an even bigger challenge!” (Qualitative researcher and TM, involves) | |
| “[What would help me involve PPP in numerical aspects is…] To know how or where to find participants that would be interested in participate.” (TM, NI) | ||
| Social influences | Supportive team environment | “[What would help me involve PPP in numerical aspects is…] More of a group/team effort so that it is not just left to the trial manager to present to PPI members but the trial team as a whole takes on this responsibility.” (TM, involves) |
| “I think the enthusiasm of the chief investigator to include PPI members is important. If the investigator wants to involve PPI then it will happen but if the investigator is not bothered then it proves much more difficult to include someone.” (TM, involves) | ||
| Patient and public partners’ interest | “I would be happy to share details of the numerical analysis, but have never been asked to do so - they seem satisfied with the summary explanations provided.” (TM, NI) | |
| “PPPs generally shrink back even when asked to comment on numerical aspects of a trial.” (Coinvestigator, involves) | ||
| Behavioural regulation | Guidance | “… If there was clear guidance and tools on how to do it and those tools could be easily integrated into management structures for running large scale studies then I would use them.” (CI, involves) |
| “[What would help me involve PPP in numerical aspects is…] Guidelines about PPI expectations for review of numerical aspects.” (TM, unsure about involvement) | ||
| Standard operating procedures | “[What would help me involve PPP in numerical aspects is…] have this implemented into SOPs [Standard Operating Procedures].” (TM, NI) | |
| Trial communication culture | Lack of clarity in communication about numerical and statistical aspects of trials | “language and jargon used around sample size calculations etc in design discussions. Stats/methodologists need to be open and able to discuss complex issues openly and simply.” (TM, involves) |
| “As a patient partner I feel very privileged… But as a retired maths teacher, I am very aware of the anxiety that numbers cause even otherwise very clever people - these anxieties will only be mitigated by more involvement at all levels, including the public.” (PPP, involves) | ||
| “If everyone in the research environment explained what the numbers mean clearly to all members of the team - that would make it easier to describe and facilitate involvement from patient or the public.” (TM, NI) |
CI, chief investigator; CTU, clinical trial unit; HE, health economist; NI, does not involve PPP in numerical aspects; PPI, patient and public involvement; PPP, patient and public partner; TM, trial manager.