Plain English summaryThere are well documented benefits to involving patients and the public in research. However, there is little research published about their involvement in large complex studies such as cohort multiple Randomised Controlled Trials (cmRCTs). The cmRCT method establishes a group of participants, with a common characteristic (e.g. older people) who will be followed over a number of years. Other (sub) studies can also recruit from this pool of people. This method offers researchers many advantages, including being able to recruit from more hard to reach groups. However, cmRCTs also have features which can make it more complicated to involve patients and the public. For example more than one study may take place at the same time; studies may be spread out over a large geographical area and they may include a wide range of topics. In spite of these difficulties we have developed a way of working with patients, the public and researchers that provides stability over time but allows flexibility along the way. Our model of working has saved us time and money; helped us to recruit more widely, and enabled us to focus our research in areas that are important to older people with frailty.Abstract Background There is increasing guidance on how to make the most of the rich seam of data provided by large cohort studies, and growing recognition of the benefits of cohort multiple Randomised Controlled Trials (cmRCT) in health research. In contrast, there is a lack of discussion about patient and public involvement and engagement (PPIE) in these large and complex research infrastructures. Our aim was to create a structure to enable meaningful, sustainable public involvement within the cmRCT framework. We have established a core reference group of four key individuals with extensive links to other relevant local community structures and individuals. Results Using the CARE 75+ model we have engaged with a wide variety of patients and the public in a relatively short space of time. Activities have included scrutiny of protocols and assessment tools, and process evaluations; resulting in system efficiencies, increased recruitment and a more focused research agenda. Conclusions There is a need for strong public oversight and flexible models of PPIE in cmRCTs. The model of PPIE developed in the Community Ageing Research 75+ study presents one potential way to foster expertise and enable diversity.

BackgroundThe electronic frailty index (eFI) has been developed and validated using routine primary care electronic health record data. The focus of the original big data study was on predictive validity as a form of criterion validation. Convergent validity is a subtype of construct validity and considered a core component of the validity of a test. ObjectiveTo investigate convergent validity between the eFI and research standard frailty measures. DesignCross-sectional validation study using data from the Community Ageing Research 75+ (CARE 75+) cohort. SettingMulti-site UK community-based cohort study. Subjects353 community-dwelling older people (median age 80 years, IQR 77 to 84), excluding care home residents and people in the terminal stage of life. Median eFI score of participants was 0.22 (IQR 0.14 to 0.31). MethodsConvergent validities between the eFI and: a research standard frailty index; the phenotype model of frailty; Clinical Frailty Scale; and Edmonton Frail Scale were assessed using scatter plots and Spearman's rank tests to estimate correlation coefficients (Spearman's rho, ) and 95% confidence intervals. ResultsResults indicate strong correlation between the eFI and both the research standard frailty index ( =0.68, 95% CI 0.62 to 0.74) and Edmonton Frail Scale ( =0.63, 95% CI 0.57 to 0.69). There was evidence for moderate correlation between the eFI and

Background and objectives: delirium is a distressing but potentially preventable condition common in older people in long-term care. It is associated with increased morbidity, mortality, functional decline, hospitalization and significant healthcare costs. Multicomponent interventions, addressing delirium risk factors, have been shown to reduce delirium by one-third in hospitals. It is not known whether this approach is also effective in long-term care. In previous work, we designed a bespoke delirium prevention intervention, called ‘Stop Delirium!’ In preparation for a definitive trial of Stop Delirium, we sought to address key aspects of trial design for the particular circumstances of care homes.Design: a cluster randomized feasibility study with an embedded process evaluation.Setting and participants: residents of 14 care homes for older people in one metropolitan district in the UK.Intervention: Stop Delirium!: a 16-month-enhanced educational package to support care home staff to address key delirium risk factors. Control homes received usual care.Measurements: we collected data to determine the following: recruitment and attrition; delirium rates and variability between homes; feasibility of measuring delirium, resource use, quality of life, hospital admissions and falls; and intervention implementation and adherence.Results: two-thirds (215) of eligible care home residents were recruited. One-month delirium prevalence was 4.0% in intervention and 7.1% in control homes. Proposed outcome measurements were feasible, although our approach appeared to underestimate delirium. Health economic evaluation was feasible using routinely collected data.Conclusion: a definitive trial of delirium prevention in long-term care is needed but will require some further design modifications and pilot work.

Study objective-The aim was to determine whether or not there was a measurable risk of ill health associated with contact with sea water for children between the ages of 6 and 11 years old.Design and Setting-This was a prospective survey carried out on Blackpool beach. Parents of children between the ages of 6 and 11 years were interviewed over a seven week period during July, August, and September, 1990. Respondents were followed up 10-14 d after the original interview by either telephone or post. Water samples were collected on each day of the survey.Participants-939 interviews with parents or guardians were completed on the beach; 857 (919%) of these persons agreed to a follow up interview. The results ofthis study are based on 703 cases of matched data, of good quality, collected for each child on the beach and during a follow up interview.Main results-Non-compliance with the European Community microbiological imperative standards for recreational waters at Blackpool Tower and South Pier sampling sites, respectively, ranged between: 6% and 7% for total coliforms; 13% and 25% for faecal coliforms; 69% and 80% for faecal streptococci (Guide standard); 50% and 67% for salmonellae and 73% and 88% for enteroviruses. There was a significant overall increase in the mean number of symptoms reported for each child (p < 0-001). However, the prevalence of certain symptoms increased significantly only in those children who had been in contact with the water on the day of the beach interview. These symptoms included vomiting (p < 0 0009), diarrhoea (p < 0 0001), itchy skin (p < 0-0009), fever (p < 0-0013), lack of energy (p < 0 0007), and loss of appetite (p < 0-0227). None

No abstract