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Background Participants in clinical trials often do not reflect the populations that could benefit from the treatments being investigated. There are known barriers to trial participation for under-served groups, but limited evidence on strategies to alleviate these barriers to improve representation. This scoping review aimed to identify effective interventions and design features that improve the representation `of under-served groups in trials, focusing on the UK and Ireland. Methods We included methodological research studies that reported interventions to improve representation of ethnic minority groups, socioeconomically disadvantaged groups, older people, or those with impaired capacity to consent to randomised controlled trials, conducted in the UK and Ireland, published between 2000–2021. Systematic searches were conducted in November 2021 and data were independently extracted by two authors and narratively synthesised. Results Seven studies were included: one randomised controlled study embedded in five trials, one mixed-methods study, and five studies reporting ‘lessons learnt’ from one trial. We categorised the 47 reported interventions or strategies into nine broad themes: Recruitment sites, recruitment settings, community engagement, and communication with participants, incentives, inclusion criteria, flexibility, patient documentation, and the consent process. Only 28/47 interventions were evaluated, 23 of which were comparison of recruitment pathways. The randomised study found that a £100 incentive mentioned in the invitation letter increased positive responses overall across drug trials in cardiovascular disease and hypertension, but not for older people or those living in the most deprived areas. Invitation letters via GPs and working with communities were reported as successful recruitment pathways in recruiting different under-served populations. Conclusions Interventions aiming to improve the recruitment of under-served groups in the UK and Ireland were reported across seven papers, but their effectiveness was rarely rigorously evaluated. Included studies were context specific. Using a variety of recruitment methods is likely to help achieve a more diverse cohort.

Background: Testicular cancer (TC) is the most common malignancy in men under 50 years. Athletes are particularly at risk of testicular trauma and diseases. Experiencing negative testicular symptoms does not necessarily imply that men seek help. Men’s awareness of testicular diseases is often lacking and their intention to seek help for testicular symptoms is sub-optimal. The use of virtual reality (VR) may be effective in promoting men’s awareness of testicular diseases. The Enhancing Men's Awareness of Testicular diseases (E-MAT) feasibility trial aims to test the effect of E-MATVR (intervention; interactive experience using virtual reality [VR]) compared to information delivered Electronically E-MATE (control; same information as E-MATVR delivered as plain text and images) on testicular knowledge, and testicular self-examination among male athletes affiliated with a national sports organisation. The overall aim of this mixed method process evaluation will be to describe (i) the experiences of participants and key stakeholders (e.g., researchers); (ii) the perceived effectiveness of intervention components; (iii) acceptability of the feasibility trial and intervention procedures; (iv) the relationship between implementation, mechanisms, and context; and (v) the barriers and facilitators to support effective conduct of a future definitive trial. Methods: This mixed method process evaluation will use a descriptive realist evaluation. Quantitative data will be gathered using a usability and satisfaction survey, in addition to fidelity checks during intervention delivery. Quantitative data will be analysed using descriptive and inferential statistics. Qualitative data will be gathered from semi-structured interviews and focus groups with participants and key stakeholders to investigate their experiences of E-MATVR and E-MATE, and explore areas for improvement. Thematic analysis of transcripts will be conducted. Conclusions: This process evaluation will provide an in-depth understanding of how the interventions worked within this cohort and lessons for a future definitive trial.

Background: Testicular cancer (TC) is the most common malignancy in men under 50 years. Athletes are particularly at risk of testicular trauma and diseases. Experiencing negative testicular symptoms does not necessarily imply that men seek help. Men’s awareness of testicular diseases is often lacking and their intention to seek help for testicular symptoms is sub-optimal. The use of virtual reality (VR) may be effective in promoting men’s awareness of testicular diseases. The Enhancing Men's Awareness of Testicular diseases (E-MAT) feasibility trial aims to test the effect of E-MATVR (intervention; interactive experience using virtual reality [VR]) compared to information delivered Electronically E-MATE (control; same information as E-MATVR delivered as plain text and images) on testicular knowledge, and testicular self-examination among male athletes affiliated with a national sports organisation. The overall aim of this mixed method process evaluation will be to describe (i) the experiences of participants and key stakeholders (e.g., researchers); (ii) the perceived effectiveness of intervention components; (iii) acceptability of the feasibility trial and intervention procedures; (iv) the relationship between implementation, mechanisms, and context; and (v) the barriers and facilitators to support effective conduct of a future definitive trial. Methods: This mixed method process evaluation will use a descriptive realist evaluation. Quantitative data will be gathered using a usability and satisfaction survey, in addition to fidelity checks during intervention delivery. Quantitative data will be analysed using descriptive and inferential statistics. Qualitative data will be gathered from semi-structured interviews and focus groups with participants and key stakeholders to investigate their experiences of E-MATVR and E-MATE, and explore areas for improvement. Thematic analysis of transcripts will be conducted. Conclusions: This process evaluation will provide an in-depth understanding of how the interventions worked within this cohort and lessons for a future definitive trial.

Background: Potential dietary strategies for controlling hyperphosphataemia include the use of protein sources with lower phosphorus bioavailability such as pulses and nuts, focus on phosphorus to protein ratios and the avoidance of all phosphate additives. Methods: We conducted a controlled crossover feeding study in 8 haemodialysis (HD) patients to investigate the acute postprandial effect of a modified versus standard low phosphorus diet for one day on serum phosphate, potassium and intact parathyroid levels in prevalent HD patients. Each participant consumed the modified diet on one day and the standard diet on a second day one week apart. The modified diet included beef and less dairy, with a lower phosphorus to protein ratio, as well as plant-based protein, whole grains, pulses and nuts containing phytates which reduces phosphorus bioavailability. Both diets were tailored for each participant to provide 1.1g protein/kg ideal body weight. Participants provided fasting bloods before breakfast, a pre-prandial sample before the lunch time main meal and samples at one-hour intervals for the four hours after the lunch time main meal, for analysis of phosphate, potassium and intact parathyroid hormone (iPTH). Results: At four hours post the lunch time main meal on each study day, individuals on the modified diet had serum phosphate readings 0.30 mmol/l lower than when on the standard diet (p-value = 0.015, 95% confidence interval [CI] -0.57, -0.04). The corresponding change in serum potassium at four hours was a decrease of 0.675 mmol/l (p-value = 0.011, CI -1.25, -0.10). Conclusions: Decreases in both serum phosphate and serum potassium readings on a modified low phosphorus diet encourage further larger studies to explore the possibility of greater food choice and healthier plant-based diets in HD patients. ClinicalTrials.gov registration: NCT04845724 (15/04/2021)