Search

Introduction: Diabetes is one of the leading causes of chronic kidney disease. Social deprivation is recognised as a risk factor for complications of diabetes, including diabetic kidney disease. The effect of deprivation on rate of decline in renal function has not been explored in the Irish Health System to date. The objective of this study is to explore the association between social deprivation and the development/progression of diabetic kidney disease in a cohort of adults living with diabetes in Ireland., Methods: This is a retrospective cohort study using an existing dataset of people living with diabetes who attended the diabetes centre at University Hospital Galway from 2012 to 2016. The variables included in this dataset include demographic variables, type and duration of diabetes, clinical variables such as medication use, blood pressure and BMI and laboratory data including creatinine, urine albumin to creatinine to ratio, haemoglobin A1c and lipids. This dataset will be updated with laboratory data until January 2023. Individual's addresses will be used to calculate deprivation indices using the Pobal Haase Pratschke (HP) deprivation index. Rate of renal function decline will be calculated using linear mixed-effect models. The relationship between deprivation and renal function will be assessed using linear regression (absolute and relative rate of renal function decline based on eGFR) and logistic regression models (rapid vs. non-rapid decline)., Competing Interests: Competing interests: CC received funding to attend national and international diabetes conferences from Novo Nordisk. TPG received honoraria for speaker fees and/or advisory boards from Novo Nordisk, Sanofi Aventis, Mundipharma Pharmaceuticals, Dexcom, Abbott Diabetes Care, AbbVie, Astra Zeneca and Eli Lilly., (Copyright: © 2024 Casey C et al.)

Background: Diabetes is a growing global health problem. International guidelines recommend identification, screening, and referral to behavioural programmes for those at high risk of developing type 2 diabetes. Diabetes prevention programmes (DPPs) can prevent type 2 diabetes in those at high risk, however many eligible participants are not referred to these programmes. Healthcare workers (HCWs) are pivotal to the referral and recruitment processes. This study aims to identify, appraise and synthesise the evidence on barriers and facilitators to referral and recruitment to DPPs from the perspective of HCWs., Methods: A "best fit" framework synthesis method will synthesise qualitative, quantitative, and mixed methods evidence on factors that affect HCWs referral and recruitment to DPPs, with the Theoretical Domains Framework (TDF) as the a priori framework. MEDLINE, EMBASE, CINAHL, PsychINFO, Web of Science and Scopus will be searched for primary studies published in English. Year of publication will be restricted to the last 26 years (1997-2023). Quality will be assessed using the Mixed Methods Appraisal Tool. A mix of deductive coding using the TDF and inductive coding of data that does not fit the TDF will be synthesised into themes representing the whole dataset. The relationships between the final set of themes will be explored to create a new model to understand HCWs' perspectives on referral and recruitment to DPPs. Sensitivity analysis will be carried out on this conceptual model. Confidence in the synthesised findings will be assessed using the GRADE-CERQual approach. One author will screen, extract, appraise the literature while a second author will independently verify a 20% sample at each stage., Discussion: Participation in DPPs is key for programme impact. HCWs typically identify those at risk and refer them to DPPs. Understanding HCWs' perspectives on the barriers and facilitators to referral and recruitment will inform future implementation of DPPs., Competing Interests: No competing interests were disclosed., (Copyright: © 2024 Haseldine C et al.)

Background: The Cork and Kerry Diabetes and Heart Disease Study was established to investigate the prevalence of diabetes and cardiovascular disease among middle-aged adults in Ireland. The Mitchelstown cohort was recruited from a single large primary care centre between 2010-2011. A rescreen of this cohort was conducted in 2015. Methods: Data were collected on cardiovascular health and associated risk factors. In addition, the rescreen incorporated new measures which included information on cognition and frailty, medication adherence, dietary factors and the collection of stool samples with RNA sequencing of the gut microbiome. Results: Of 2047 participants in the original cohort, 237 (11.6%) were deceased, too ill to participate or were lost to follow-up. Of the remaining 1810 baseline study participants, 1378 men and women aged 51-77 years agreed to take part in the rescreen (response rate of 76.1%). The prevalence of hypertension was high, ranging from 50% to 64% depending on the measurement method. An investigation of the association of gut microbiota with metabolic syndrome and obesity indicated greater microbiome diversity in metabolically healthy non-obese individuals relative to their unhealthy counterparts. Analysis of prescribing data over time demonstrated a high prevalence of potentially inappropriate prescribing among older-aged people in primary care which increased as they progressed to more advanced old age. Conclusions: The rescreen has provided new insights into cardiovascular health. In addition, this study is embedded in a single primary care centre, enabling passive follow-up of study participants through electronic health records. All data collected at baseline and rescreen are maintained and stored at the School of Public Health, University College Cork and specific proposals for future collaborations are welcome., Competing Interests: No competing interests were disclosed., (Copyright: © 2023 Stamenic D et al.)

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 PWD 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., Competing Interests: No competing interests were disclosed., (Copyright: © 2023 Racine E et al.)

Background : We assessed the mental health of individuals in the general population, during an initial period of easing of COVID-19 restrictions in the Republic of Ireland (RoI). Methods: Data were collected through a nationally representative cross-sectional telephone survey, during the first period of easing of restrictions during the COVID-19 pandemic between May and July 2020. Mental health was examined using the Patient Health Questionnaire Anxiety Depression Scale. Poisson regression analyses were conducted to estimate risk ratios with robust variance estimation of the association between selected demographic factors and the risk of having depression and anxiety symptoms. Results : Of the 1,983 participants, 27.7% (n = 549; 95% CI: 0.26 - 0.30) reported depression and anxiety symptoms, while 74 (3.8%; 95% CI: 0.03 - 0.05) disclosed self-harm and/or suicidal thoughts. Females (RR: 1.60, 95% CI: 1.37 - 1.87, p < 0.0005), employed individuals who experienced a change in work status (RR: 1.50, 95% CI: 1.24 - 1.82, p < 0.0005), participants cocooning due to a health condition (RR: 1.34, 95% CI: 1.08 - 1.66, p< 0.01), participants who were self-isolating (RR: 1.25, 95% CI: 1.03 - 1.51, p=0.025) and moderate-heavy drinkers (RR: 1.27, 95% CI: 1.09 - 1.47, p<0.01) were at increased risk of depression and anxiety. Young people aged 18-29 years and those in the two lowest income categories were most likely to report self-harm and/or suicidal thoughts. Conclusion : As the COVID-19 pandemic continues, with further waves and associated restrictions, the impact on mental health in the population as a whole and in specific subgroups must be considered. Study protocol registration : doi.org/10.12688/hrbopenres.13103.2., Competing Interests: No competing interests were disclosed., (Copyright: © 2022 Troya MI et al.)

Background : Diabetic foot ulcers are one of the most common lower extremity complications of diabetes, with the lifetime risk of a person developing a DFU estimated to be as high as 34%. It is recommended that those with diabetes receive an annual review of their feet, by a trained healthcare professional, to identify risk factors for ulceration and allow for subsequent risk stratification, patient education and provision of appropriate care to prevent ulceration and amputation. Internationally, while many countries have a diabetic foot care pathway, it is not a structured population health screening programme unlike other areas of preventive care for people with diabetes such as retinopathy screening. A structured diabetic foot screening pathway could allow for earlier identification of the at-risk foot. However, the introduction of any population screening programme should meet the Wilson and Jungner principles of screening. This paper presents a protocol for a scoping review of existing evidence on screening for the at-risk-foot against the Wilson and Junger principles. Methods:  The scoping review will be conducted in line with the six-stage methodological framework by Arksey & O'Mally and the Joanna Briggs Institute (JBI) scoping review methodology. Medline (EBSCO), Scopus, ScienceDirect and EMBASE databases will be searched. Studies relating to the burden of diabetic foot ulcers, their pathophysiology and screening tests for peripheral neuropathy and peripheral artery disease, and screening programmes will be included. A data extraction tool will be used to facilitate a chronological narrative synthesis of results. Results: These will be reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for Scoping Reviews (PRISMA-ScR). Conclusion: This scoping review will evaluate and map the evidence surrounding diabetic foot ulcers using the Wilson and Jungner principles of screening as a framework., Competing Interests: No competing interests were disclosed., (Copyright: © 2022 Pallin JA et al.)

Background:  The COVID-19 pandemic impacted on health service provision worldwide, including care for acute time sensitive conditions. Stroke and transient ischaemic attacks (TIA) are particularly vulnerable to pressures on healthcare delivery as they require immediate diagnosis and treatment. The global impact of the COVID-19 pandemic on prehospital emergency care for stroke/TIA is still largely unknown. Thus, the aim of this study is to conduct a systematic review and meta-analysis to investigate the impact of the COVID-19 pandemic on prehospital emergency care for stroke and TIA. Methods:  Following the Preferred Reporting Items for Systematic Reviews and Meta Analyses (PRISMA) guidelines, the review is registered on PROSPERO (registration number CRD42022315260). Peer-reviewed quantitative studies comparing prehospital emergency care for adults with stroke/TIA before and during the COVID-19 pandemic will be considered for inclusion. The outcomes of interest are ambulance times and emergency call volumes for stroke/TIA. A systematic search of databases including PubMed, Embase and Scopus will be conducted. Two authors will independently screen studies for inclusion based on predetermined inclusion and exclusion criteria. Data extraction and quality assessment will be conducted by two authors. Meta-analysis will be performed to calculate overall pooled estimates of ambulance times (primary outcome) and stroke/TIA call volumes (secondary outcome), where appropriate.  Where heterogeneity is low a fixed-effects model will be used and where heterogeneity is high a random-effects model will be used. Subgroup and sensitivity analyses will include location, stroke/TIA diagnosis and COVID-19 case numbers. Results:  Data on primary and secondary outcomes will be provided. Results of subgroup/sensitivity analyses and quality assessment will also be presented. Conclusions:  This review will identify existing evidence reporting the impact of the COVID-19 pandemic on prehospital emergency care for adult patients with stroke/TIA and provide summary estimates of effects on ambulance response times., Competing Interests: No competing interests were disclosed., (Copyright: © 2022 Burton E et al.)

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., Competing Interests: No competing interests were disclosed., (Copyright: © 2022 Racine E et al.)

Background The COVID-19 pandemic impacted on health service provision worldwide, including care for acute time sensitive conditions. Stroke and transient ischaemic attacks (TIA) are particularly vulnerable to pressures on healthcare delivery as they require immediate diagnosis and treatment. The global impact of the COVID-19 pandemic on prehospital emergency care for stroke/TIA is still largely unknown. Thus, the aim of this study is to conduct a systematic review and meta-analysis to investigate the impact of the COVID-19 pandemic on prehospital emergency care for stroke and TIA. Methods Following the Preferred Reporting Items for Systematic Reviews and Meta Analyses (PRISMA) guidelines, the review is registered on PROSPERO (registration number CRD42022315260). Peer-reviewed quantitative studies comparing prehospital emergency care for adults with stroke/TIA before and during the COVID-19 pandemic will be considered for inclusion. The outcomes of interest are ambulance response times and emergency call volumes for stroke/TIA. A systematic search of databases including PubMed, Embase and Scopus will be conducted. Two authors will independently screen studies for inclusion based on predetermined inclusion and exclusion criteria. Data extraction and quality assessment will be conducted by two authors. Meta-analysis will be performed to calculate overall pooled estimates of ambulance response times (primary outcome) and stroke/TIA call volumes (secondary outcome), where appropriate.  Where heterogeneity is low a fixed-effects model will be used and where heterogeneity is high a random-effects model will be used. Subgroup and sensitivity analyses will include location, stroke/TIA diagnosis and COVID-19 case numbers. Results Data on primary and secondary outcomes will be provided. Results of subgroup/sensitivity analyses and quality assessment will also be presented. Conclusions  This review will identify existing literature reporting the impact of the COVID-19 pandemic on prehospital emergency care for adult patients with stroke/TIA and provide summary estimates of effects on ambulance response times., Competing Interests: No competing interests were disclosed., (Copyright: © 2022 Burton E et al.)

Background : We assessed the mental health of individuals in the general population, during an initial period of easing of COVID-19 restrictions in the Republic of Ireland (RoI). Methods: Data were collected through a nationally representative cross-sectional telephone survey, during the first period of easing of restrictions during the COVID-19 pandemic between May and July 2020. Mental health was examined using the Patient Health Questionnaire Anxiety Depression Scale. Poisson regression analyses were conducted to estimate risk ratios with robust variance estimation of the association between selected demographic factors and the risk of having depression and anxiety symptoms. Results : Of the 1,983 participants, 27.7% (n = 549; 95% CI: 0.26 - 0.30) reported depression and anxiety symptoms, while 74 (3.8%; 95% CI: 0.03 - 0.05) disclosed self-harm and/or suicidal thoughts. Females (RR: 1.60, 95% CI: 1.37 - 1.87, p < 0.0005), employed individuals who experienced a change in work status (RR: 1.50, 95% CI: 1.24 - 1.82, p < 0.0005), participants cocooning due to a health condition (RR: 1.34, 95% CI: 1.08 - 1.66, p< 0.01), participants who were self-isolating (RR: 1.25, 95% CI: 1.03 - 1.51, p=0.025) and moderate-heavy drinkers (RR: 1.27, 95% CI: 1.09 - 1.47, p<0.01) were at increased risk of depression and anxiety. Young people aged 18-29 years and those in the two lowest income categories were most likely to report self-harm and/or suicidal thoughts. Conclusion : As the COVID-19 pandemic continues, with further waves and associated restrictions, the impact on mental health in the population as a whole and in specific subgroups must be considered. Study protocol registration : doi.org/10.12688/hrbopenres.13103.2., Competing Interests: No competing interests were disclosed., (Copyright: © 2021 Troya MI et al.)

Introduction Understanding primary care practices' 'readiness' to engage in trials and their experience is important to inform trial procedures and supports. Few studies report on the feasibility of study procedures though this is a central part of pilot trials. We explored the acceptability and feasibility of study procedures of a cluster randomised pilot trial of an intervention in primary care to improve uptake of Ireland's national diabetic retinopathy programme.  Methods As part of the embedded mixed-methods process evaluation, quantitative and qualitative data were gathered across four general practices participating in the intervention. Interviews were conducted with a purposive sample of staff. Research logs on time spent on intervention delivery, staff assignment, resources, problems/changes, and reasons for drop-outs, were maintained over the course of intervention rollout, and practice audit data were analysed. Quantitative outcomes included recruitment, retention, completion, and data quality and completeness. Qualitative data on perceptions and experience of the pilot trial procedures were analysed using the Framework Method. Findings Nine staff (3 GPs, 4 nurses, 2 administrators) were interviewed. An interest in the topic area or in research motivated practices to take part in the trial. Reimbursement meant they could ' afford ' to participate. Staff valued the researcher briefing at the start of the trial, to avoid ' going in slightly blind'. While staff varied in audit skills and confidence, and some found this aspect of data collection challenging, a ' step-by-step' audit manual and regular researcher contact, helped them stay on track and troubleshoot during data collection. Audit quality was acceptable overall, however there were some issues, incorrect assignment of patient status being most common. Conclusion The IDEAs trial procedures were acceptable and feasible for primary care staff, however, challenges with conducting the audit may reflect staff skills gaps and the need for greater guidance and support from researchers., Competing Interests: No competing interests were disclosed., (Copyright: © 2021 Riordan F et al.)

Background: Depression and diabetes distress are common in people with type 2 diabetes (T2DM). These conditions are independently associated with poorer T2DM outcomes and increased healthcare utilisation and costs. Questions remain regarding the most appropriate ways of initially detecting depression and diabetes distress in this group. Diabetes guidelines recommend depression screening in primary care for people with T2DM but their implementation in practice is suboptimal. As health care professionals influence detection practices, their perceptions and experiences of these guidelines can improve understanding of aspects of the guidelines that work, and those which are more difficult to implement in practice. This study describes the protocol for a qualitative evidence synthesis of primary care health professionals' perceived barriers and enablers to screen for and diagnose depression and diabetes distress in people with T2DM. Methods and analysis: Primary qualitative studies will be identified using a systematic search of electronic databases and supplementary searching. We selected 'best-fit framework synthesis' as the approach to synthesise primary data using the RETREAT (Review question-Epistemology-Time/Timescale-Resources-Expertise-Audience and purpose-Type of Data) framework. Quality appraisal of primary studies and confidence in the overall review findings will be determined using the CASP (Critical Appraisal Skills Programme) and the GRADE-CERQual (Grading of Recommendations Assessment, Development, and Evaluation Confidence in the Evidence from Reviews of Qualitative research), respectively. Discussion: The planned review will provide the first, single point of reference of the available synthesised qualitative evidence on this topic. It will apply recommended approaches to ensure rigor and robustness of study and contribute meaningfully to understanding of how depression and diabetes distress can be initially detected in people with T2DM. This protocol is registered with the International Prospective Register of Systematic Reviews (PROSPERO) [registration number: CRD42019145483]., Competing Interests: No competing interests were disclosed., (Copyright: © 2020 McGrath N et al.)

Background: Depression and diabetes distress are common in people with type 2 diabetes (T2DM). These conditions are independently associated with poorer T2DM outcomes and increased healthcare utilisation and costs. Questions remain regarding the most appropriate ways of initially detecting depression and diabetes distress in this group. Diabetes guidelines recommend depression screening in primary care for people with T2DM but their implementation in practice is suboptimal. As health care professionals influence detection practices, their perceptions and experiences of these guidelines can improve understanding of aspects of the guidelines that work, and those which are more difficult to implement in practice. This study describes the protocol for a qualitative evidence synthesis of primary care health professionals' perceived barriers and enablers to screen for and diagnose depression and diabetes distress in people with T2DM. Methods and analysis: Primary qualitative and mixed method studies will be identified using a systematic search of electronic databases and the CLUSTER (Citations, Lead authors, Unpublished materials, Scholar searches, Theories, Early examples, Related projects) approach. We selected 'best-fit framework synthesis' as the approach to synthesise primary data using the RETREAT (Review question-Epistemology-Time/Timescale-Resources-Expertise-Audience and purpose-Type of Data) framework. Quality appraisal of primary studies and confidence in the overall review findings will be determined using the CASP (Critical Appraisal Skills Programme) and the GRADE-CERQual (Grading of Recommendations Assessment, Development, and Evaluation Confidence in the Evidence from Reviews of Qualitative research), respectively. Discussion: The planned review will provide the first, single point of reference of the available synthesised qualitative evidence on this topic. It will apply recommended approaches to ensure rigor and robustness of study and contribute meaningfully to understanding of how depression and diabetes distress can be initially detected in people with T2DM. This protocol is awaiting processing by the International Prospective Register of Systematic Reviews (PROSPERO) [ID number 145483]., Competing Interests: No competing interests were disclosed., (Copyright: © 2019 McGrath N et al.)

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<0.001). Other predictors were not significantly associated with consent. Conclusions: Over one third of people eligible to participate in RetinaScreen had not consented. Research is needed to understand barriers and enablers of DRS uptake in the Irish context. Implementing strategies to improve DRS uptake (consent and attendance) should be a priority., Competing Interests: No competing interests were disclosed., (Copyright: © 2019 Tracey M et al.)

Background : Issues with questionnaire completion introduce bias and limit examinations in trials. Improving communication with participants about trial processes, such as outcome and questionnaire development, may improve questionnaire completion and response rates. Providing information about the involvement of stakeholders in the development of core outcome sets (COS) measured in trials may improve responding by tapping into subjective norms and behaviour change mechanisms. The aim of this Study Within a Trial (SWAT) is to examine if questionnaire response rates and participants' attitudes towards questionnaire completion are impacted by providing information about COS use in a trial of a complex intervention. Methods: This is a randomised, single-blinded, parallel group intervention SWAT, embedded within a feasibility trial of an infant feeding intervention to prevent childhood obesity. The SWAT intervention consisting of a brief written description and explanation about the development and use of a COS of infant feeding outcomes to prevent childhood obesity, used in the trial. Participants are parents or caregivers of infants aged two months at questionnaire completion. Participants will be randomly assigned to receive the SWAT intervention prior to questionnaire completion (I1 condition), or to receive the information following completion of all questionnaires (I2 condition). The SWAT will be assessed using closed-ended and an open-ended question to evaluate participants' attitudes about questionnaire completion. Response rates will be measured as proportion of full questionnaire completion and individual item response rates. Discussion:  We hypothesise that providing information about development and use of a COS will increase questionnaire response rates and attitudes toward questionnaire completion relative to the control condition. Findings will indicate the potential usefulness of this strategy for improving participant attitudes and response rates in trials.  Trial Registration: This SWAT is registered on the Northern Ireland Hub for Trials Methodology: Research SWAT Repository ( SWAT57)., Competing Interests: No competing interests were disclosed., (Copyright: © 2019 Griffin C et al.)

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., Competing Interests: No competing interests were disclosed., (Copyright: © 2018 Racine E et al.)