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Abstract Background Older people in poor health are more likely to need extra money, aids and adaptations to allow them to remain independent and cope with ill health, yet in the UK many do not claim the welfare benefits to which they are entitled. Welfare rights advice interventions lead to greater welfare income, but have not been rigorously evaluated for health benefits. This study will evaluate the effects on health and well-being of a domiciliary welfare rights advice service provided by local government or voluntary organisations in North East England for independent living, socio-economically disadvantaged older people (aged ≥60 yrs), recruited from general (primary care) practices. Methods/Design The study is a pragmatic, individually randomised, single blinded, wait-list controlled trial of welfare rights advice versus usual care, with embedded economic and qualitative process evaluations. The qualitative study will examine whether the intervention is delivered as intended; explore responses to the intervention and examine reasons for the trial findings; and explore the potential for translation of the intervention into routine policy and practice. The primary outcome is the effect on health-related quality of life, measured using the CASP 19 questionnaire. Volunteer men and women aged ≥60 years (1/household) will be identified from general practice patient registers. Patients in nursing homes or hospitals at the time of recruitment will be excluded. General practice populations will be recruited from disadvantaged areas of North East England, including urban, rural and semi-rural areas, with no previous access to targeted welfare rights advice services delivered to primary care patients. A minimum of 750 participants will be randomised to intervention and control arms in a 1:1 ratio. Discussion Achieving a trial design that is both ethical and acceptable to potential participants, required methodological compromises. The choice of follow-up length required a trade-off between sufficient time to demonstrate health impact and the need to allow the control group access to the intervention as early as possible. The study will have implications for fundamental understanding of social inequalities and how to tackle them, and provides a model for similar evaluations of health-orientated social interventions. If the health benefits of this intervention are proven, targeted welfare rights advice services should be extended to ensure widespread provision for older people and other vulnerable groups. Current Controlled Trials ISRCTN Number ISRCTN37380518

Background: The INVESTIGATE-I study was designed to inform a future definitive randomised trial of invasive urodynamic testing, compared to basic clinical assessment with noninvasive tests prior to surgical treatment, in women with stress urinary incontinence or stress-predominant mixed urinary incontinence. In a pilot randomised controlled trial, women from seven participating sites were screened, consented and randomised. Overall, 771 patients were identified from clinic notes and correspondence as being potential recruits and were sent the Patient Information Leaflet. Of those screened, 284 were deemed eligible, giving an overall 'screen positive' rate of 37%. The numbers screened at individual centres varied between 14 and 399; the 'screen positive' rate varied between 22 and 79% and the percentage of eligible women recruited varied between 55 and 100%. The aim of this additional substudy was to explore why 'screen positive' rates may have varied so widely between apparently similar sites. Results: All 11 trial staff involved in screening in the seven recruiting sites were asked to evaluate a series of 20 identical vignettes, mainly based on actual general practitioner referral letters. Of the vignettes, 16 mentioned one or more definite inclusion criteria; the remainder had possible inclusions. Four had definite exclusions; 12 had possible exclusions. Free-text comments were sought to clarify the screeners' decisions. For six vignettes everyone agreed that the patient was eligible; for one all agreed she was not eligible; the breakdown for the remainder was mixed. Free-text comments illuminated uncertainties that may have led to variability in judging potential eligibility. Conclusions: Variability in judgements about potential trial eligibility highlights the importance of explicit and objective inclusion and exclusion criteria, and of agreed strategies for making judgements when information is missing. During the development and planning of trials, vignettes might be a valuable tool for training those involved in screening and recruiting patients, for identifying potential problems and ensuring greater consistency in the application of eligibility criteria. [ABSTRACT FROM AUTHOR]

Background: Development of longer term stroke rehabilitation services is limited by lack of evidence of effectiveness for specific interventions and service models. We describe the protocol for a multicentre randomised controlled trial which is evaluating an extended stroke rehabilitation service. The extended service commences when routine 'organised stroke care' (stroke unit and early supported discharge (ESD)) ends. Methods/design: This study is a multicentre randomised controlled trial with health economic and process evaluations. It is set within NHS stroke services which provide ESD. Participants are adults who have experienced a new stroke (and carer if appropriate), discharged from hospital under the care of an ESD team. The intervention group receives an extended stroke rehabilitation service provided for 18 months following completion of ESD. The extended rehabilitation service involves regular contact with a senior ESD team member who leads and coordinates further rehabilitation. Contact is usually by telephone. The control group receives usual stroke care post-ESD. Usual care may involve referral of patients to a range of rehabilitation services upon completion of ESD in accordance with local clinical practice. Randomisation is via a central independent web-based service. The primary outcome is extended activities of daily living (Nottingham Extended Activities of Daily Living Scale) at 24 months post-randomisation. Secondary outcomes (at 12 and 24 months post-randomisation) are health status, quality of life, mood and experience of services for patients, and quality of life, experience of services and carer stress for carers. Resource use and adverse events are also collected. Outcomes are undertaken by a blinded assessor. Implementation and delivery of the extended stroke rehabilitation service will also be described. Semi-structured interviews will be conducted with a subsample of participants and staff to gain insight into perceptions and experiences of rehabilitation services delivered or received. Allowing for 25% attrition, 510 participants are needed to provide 90% power to detect a difference in mean Nottingham Extended Activities of Daily Living Scale score of 6 with a 5% significance level. Discussion: The provision of longer term support for stroke survivors is currently limited. The results from this trial will inform future stroke service planning and configuration. Trial registration: This trial was registered with ISRCTN (identifier: ISRCTN45203373) on 9 August 2012. [ABSTRACT FROM AUTHOR]