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Background: UK Medical Research Council guidelines recommend end-user involvement in intervention development. There is limited evidence on the contributions of different end-users to this process. The aim of this Study Within A Trial (SWAT) was to identify and compare contributions from two groups of end-users - people with diabetes’ (PWD) and healthcare professionals’ (HCPs), during consensus meetings to inform an intervention to improve retinopathy screening uptake. Methods: A mixed method, explanatory sequential design comprising a survey and three semi-structured consensus meetings was used. PWD were randomly assigned to a diabetes only or combined meeting. HCPs attended a HCP only or combined meeting, based on availability. In the survey, participants rated intervention proposals on acceptability and feasibility. Survey results informed the meeting topic guide. Transcripts were analysed deductively to compare feedback on intervention proposals, suggestions for new content, and contributions to the final intervention. Results: Overall, 13 PWD and 17 HCPs completed the survey, and 16 PWD and 15 HCPs attended meetings. For 31 of the 39 intervention proposals in the survey, there were differences (≥10%) between the proportion of HCPs and PWD who rated proposals as acceptable and/or feasible. End-user groups shared and unique concerns about proposals; both were concerned about informing but not scaring people when communicating risk, while concerns about resources were mostly unique to HCPs and concerns about privacy were mostly unique to PWD. Fewer suggestions for new intervention content from the combined meeting were integrated into the final intervention as they were not feasible for implementation in general practice. Participants contributed four new behaviour change techniques not present in the original proposals: goal setting (outcome), restructuring the physical environment, material incentive (behaviour) and punishment. Conclusions: Preferences for intervention content may differ across end-user groups, with feedback varying depending on whether end-users are involved simultaneously or separately.

Background and Aims: Patient and Public Involvement (PPI), defined as research carried out ‘with’ or ‘by’ members of the public rather than ‘to’, ‘about’ or ‘for’ them, is increasingly recognized as an essential component of health research. The rationale for PPI is based on a moral argument where the people whose lives are most affected by research should have a say in what is researched and how it is carried out, and a pragmatic argument that PPI can improve research quality. Although PPI is now required by many research funders, academic journals, and ethics committees, progress to achieve greater involvement has been patchy and slow. There is a lack of clarity on how to conduct ‘strong’ PPI and on why PPI should be used. Research is needed on suitable PPI methodologies and on the impact of PPI if we are to develop a shared understanding of what works, when, how and why. Therefore, the overarching aim of this thesis was to contribute to the evidence on the methods and impact of PPI by exploring PPI contributors’ experiences and contributions at the design, conduct and dissemination stages of trials. Methods: At the design stage, two Studies Within A Trial (SWAT) were conducted within the intervention development phase of the Improving Diabetes Eye-screening Attendance (IDEAs) pilot trial. The first used a mixed methods convergent design to compare people with diabetes and healthcare professionals’ experiences of taking part in three different types of consensus meetings to inform intervention development and assess whether their experiences differed according to group composition. The second used a qualitative design to compare people with diabetes and healthcare professionals’ contributions to the intervention content and assess whether their contributions differed according to group composition. At the conduct stage, a systematic review and narrative synthesis was conducted on trial researchers’ perceptions of the impact of PPI on trial retention. At the dissemination stage, a mixed methods SWAT, including an embedded randomised trial, was conducted within the Thyroid Hormone Replacement for Subclinical Hypo-Thyroidism (TRUST) trial to identify, develop, and evaluate a patient preferred method of receiving trial results. Results: Involving PPI contributors simultaneously with other stakeholders led to a perceived lack of common ground where both stakeholders felt reluctant to fully express their opinions. It also led to conflicting opinions which were difficult to incorporate into the intervention being developed. Researchers perceived PPI to have a positive impact on trial retention as it helped trial researchers to foster a trusting relationship and improve communication with trial participants. PPI was also perceived to improve trial retention by ensuring the trial location was suitable and accessible and enabling researchers to establish cultural appropriateness by ensuring that community customs, norms and social activities were considered in the research design. Although, PPI contributors were involved in the development of the trial result letter, the results of the embedded randomised trial suggested that PPI did not make a difference to participants’ understanding of trial results. Conclusions This research shows that although there are a wide variety of methods used to involve PPI contributors, the method used can have an important influence on the impact of involvement. The results suggest that it may be more suitable and useful to involve PPI contributors separately rather than simultaneously with other stakeholder groups. This finding may assist researchers and PPI contributors in designing and conducting more meaningful and effective involvement activities. This research found that PPI can influence the research process by creating and fostering trust between researchers and participants and PPI contributors can help researchers to communicate more effectively with research participants. Although, the results suggest that PPI did not make a difference to participants’ understanding of results, suggestions for how researchers should approach future evaluations of the methods and impact of PPI have been put forward. This research paves the way forward for building an evidence base for PPI to ensure that a shared understanding of what works, when, how and why is developed among researchers, patients, members of the public and research funders.

Additional file 3:. Information leaflet and intervention material

Additional file 4. PubMed search strategy.

Additional file 2 Table S1. Theoretical Domains Framework: definitions and coding structure developed by Graham-Rowe et al. [26].

Additional file 7: Table S4. Organisational factors identified from health professional and patient interviews, coded according to CFIR and TDF.

Additional file 5: Table S2. Patient characteristics.

Additional file 1:. The TIDieR (Template for Intervention Description and Replication) Checklist

Additional file 9.

Additional file 11. Reminder letter.

Additional file 3. Questionnaire.

Additional file 8: Table S5. a Patient-level barriers or enablers mapped to TDF, BCT and operationalisation. b Professional-level barriers or enablers mapped to TDF, BCT and operationalisation. c. Organisational level barriers or enablers mapped to TDF, BCT and operationalisation.

Additional file 6: Table S3. a. Modifiable patient-level barriers and enablers and corresponding TDF mapped to BCTs. b. Modifiable professional-level barriers and enablers and corresponding TDF mapped to BCTs based on published expert consensus about effectiveness for behaviour change [5, 6] and the mapping matrix constructed by Lawrenson et al. [7]. b Modifiable professional-level barriers and enablers and corresponding TDF mapped to BCTs based on published expert consensus about effectiveness for behaviour change (1, 2) and the mapping matrix constructed by Lawrenson et al HTA. (3) a Modifiable patient-level barriers and enablers and corresponding TDF mapped to BCTs based on published expert consensus about effectiveness for behaviour chang e[5, 6] and the mapping matrix constructed by Lawrenson et al. [7]. b Modifiable professional-level barriers and enablers and corresponding TDF mapped to BCTs based on published expert consensus about effectiveness for behaviour change (1, 2) and the mapping matrix constructed by Lawrenson et al. HTA (3).

Additional file 2:. Messages delivered as part of the short script. Intervention material

Background: Diabetic retinopathy (DR) affects 8.2% of the Irish population with type 2 diabetes over 50 years and is one of the leading causes of blindness among working-age adults. Regular diabetic retinopathy screening (DRS) can reduce the risk of sight loss. In 2013, the new national screening programme (RetinaScreen) was introduced in Ireland. Maximising DRS uptake (consent to participate in the programme and attendance once invited) is a priority, therefore it is important to identify characteristics which determine DRS uptake among those with diabetes in Ireland. We report uptake in an Irish primary care population during the initial phase of implementation of RetinaScreen and investigate factors which predict consenting to participate in the programme. Methods: In two primary care practices, data were extracted from records of people with diabetes (type 1 and type 2) aged ≥18 years who were eligible to participate in RetinaScreen between November 2013 and August 2015. Records were checked for a RetinaScreen letter. RetinaScreen were contacted to establish the status of those without a letter on file. Multivariable Poisson regression was used to examine associations between socio-demographic variables and consenting. Adjusted incident rate ratios (IRR) with 95% CI were generated as a measure of association. Results: Of 722 people with diabetes, one fifth (n=141) were not registered with RetinaScreen. Of 582 who were registered, 63% (n=365) had participated in screening. Most people who consented subsequently attended (n=365/382, 96%). People who had attended another retinopathy screening service were less likely to consent (IRR 0.65 [95%CI 0.5-0.8]; p

Background: While there is an increasing consensus that clinical trial results should be shared with trial participants, there is a lack of evidence on the most appropriate methods. The aim of this study is to use a patient and public involvement (PPI) approach to identify, develop and evaluate a patient-preferred method of receiving results of the Thyroid Hormone Replacement for Subclinical Hypo-Thyroidism Trial (TRUST). Methods: This is a mixed methods study with three consecutive phases. Phase 1 iteratively developed a patient-preferred result method using semi-structured focus groups and a consensus-orientated-decision model, a PPI group to refine the method and adult literacy review for plain English assessment. Phase 2 was a single-blind parallel group trial. Irish TRUST participants were randomised to the intervention (patient-preferred method) and control group (standard method developed by lead study site). Phase 3 used a patient understanding questionnaire to compare patient understanding of results between the two methods. Results: Patients want to receive results of clinical trials, with qualitative findings indicating three key themes including ‘acknowledgement of individual contribution’, ‘contributing for a collective benefit’ and ‘receiving accessible and easy to understand results’. Building on these findings, a patient-preferred method of receiving results was developed as described above. TRUST participants (n=101) were randomised to the intervention. The questionnaire response rate was 74% for the intervention group and 62% for the control group. There were no differences in patient understanding between the two methods. Conclusions: We have demonstrated that it is feasible to conduct PPI with regard to the dissemination of results. The study identified and developed a patient-preferred method of receiving clinical trial results for older adults over 65 years. Although, in this study PPI did not influence patients’ final understanding of results, it provides a record of the process of conducting PPI within the clinical trial setting.

Background: While there is an increasing consensus that clinical trial results should be shared with trial participants, there is a lack of evidence on the most appropriate methods. The aim of this study is to use a patient and public involvement (PPI) approach to identify, develop and evaluate a patient-preferred method of receiving results of the Thyroid Hormone Replacement for Subclinical Hypo-Thyroidism Trial (TRUST). Methods: This is a mixed methods study with three consecutive phases. Phase 1 iteratively developed a patient-preferred result method using semi-structured focus groups and a consensus-orientated-decision model, a PPI group to refine the method and adult literacy review for plain English assessment. Phase 2 was a single-blind parallel group trial. Irish TRUST participants were randomised to the intervention (patient-preferred method) and control group (standard method developed by lead study site). Phase 3 used a patient understanding questionnaire to compare patient understanding of results between the two methods. Results: Patients want to receive results of clinical trials, with qualitative findings indicating three key themes including ‘acknowledgement of individual contribution’, ‘contributing for a collective benefit’ and ‘receiving accessible and easy to understand results’. Building on these findings, a patient-preferred method of receiving results was developed as described above. TRUST participants (n=101) were randomised to the intervention. The questionnaire response rate was 74% for the intervention group and 62% for the control group. There were no differences in patient understanding between the two methods. Conclusions: We have demonstrated that it is feasible to conduct PPI with regard to the dissemination of results. The study identified and developed a patient-preferred method of receiving clinical trial results for older adults over 65 years. Although, in this study PPI did not influence patients’ final understanding of results, it provides a record of the process of conducting PPI within the clinical trial setting.

University College Cork introduced its first Community-based Participatory Research (CBPR) module in 2016. The module was funded and supported by Horizon2020 funding, specifically the EnRRICH project (Enhancing Responsible Research and Innovation through Curricula in Higher Education). The module is a 5-credit module for PhD students from all disciplines in the early stages of their PhD at University College Cork. Following two fruitful partnerships in the areas of social justice / equality, community family support services and older persons, there was a keen interested to explore partnerships in markedly different areas such as environmental sustainability. A dialogue ensued with CEF where the opportunity and feasibility to collaborate on the CBPR module was explored.

Interview Topic Guide. (PDF 342 kb)

Full monitoring survey. (DOCX 744 kb)

Background: While there is an increasing consensus that clinical trial results should be shared with trial participants, there is a lack of evidence on the most appropriate methods. The aim of this study is to use a patient and public involvement (PPI) approach to identify, develop and evaluate a patient-preferred method of receiving results of the Thyroid Hormone Replacement for Subclinical Hypo-Thyroidism Trial (TRUST). Methods: This is a mixed methods study with three consecutive phases. Phase 1 iteratively developed a patient-preferred result method using semi-structured focus groups and a consensus-orientated-decision model, a PPI group to refine the method and adult literacy review for plain English assessment. Phase 2 was a single-blind parallel group trial. Irish TRUST participants were randomised to the intervention (patient-preferred method) and control group (standard method developed by lead study site). Phase 3 used a patient understanding questionnaire to compare patient understanding of results between the two methods. Results: Patients want to receive results of clinical trials, with qualitative findings indicating three key themes including 'acknowledgement of individual contribution', 'contributing for a collective benefit' and 'receiving accessible and easy to understand results'. Building on these findings, a patient-preferred method of receiving results was developed as described above. TRUST participants (n=101) were randomised to the intervention. The questionnaire response rate was 74% for the intervention group and 62% for the control group. There were no differences in patient understanding between the two methods. Conclusions: We have demonstrated that it is feasible to conduct PPI with regard to the dissemination of results. The study identified and developed a patient-preferred method of receiving clinical trial results for older adults over 65 years. Although, in this study PPI did not influence patients' final understanding of results, it provides a record of the process of conducting PPI within the clinical trial setting.

Background: While there is an increasing consensus that clinical trial results should be shared with trial participants, there is a lack of evidence on the most appropriate methods. The aim of this study is to use a patient and public involvement (PPI) approach to identify, develop and evaluate a patient-preferred method of receiving results of the Thyroid Hormone Replacement for Subclinical Hypo-Thyroidism Trial (TRUST). Methods: This is a mixed methods study with three consecutive phases. Phase 1 iteratively developed a patient-preferred result method using semi-structured focus groups and a consensus-orientated-decision model, a PPI group to refine the method and adult literacy review for plain English assessment. Phase 2 was a single-blind parallel group trial. Irish TRUST participants were randomised to the intervention (patient-preferred method) and control group (standard method developed by lead study site). Phase 3 used a patient understanding questionnaire to compare patient understanding of results between the two methods. Results: Patients want to receive results of clinical trials, with qualitative findings indicating three key themes including ‘acknowledgement of individual contribution’, ‘contributing for a collective benefit’ and ‘receiving accessible and easy to understand results’. Building on these findings, a patient-preferred method of receiving results was developed as described above. TRUST participants (n=101) were randomised to the intervention. The questionnaire response rate was 74% for the intervention group and 62% for the control group. There were no differences in patient understanding between the two methods. Conclusions: We have demonstrated that it is feasible to conduct PPI with regard to the dissemination of results. The study identified and developed a patient-preferred method of receiving clinical trial results for older adults over 65 years. Although, in this study PPI did not influence patients’ final understanding of results, it provides a record of the process of conducting PPI within the clinical trial setting.