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Background: In a research study, to give a comprehensive evaluation of the impact of interventions, the outcome measures should reflect the lived experience of the condition. In dementia studies, this necessitates the use of outcome measures which capture the range of disease effects, not limited to cognitive functioning. In particular, assessing the functional impact of cognitive impairment is recommended by regulatory authorities, but there is no consensus on the optimal approach for outcome assessment in dementia research. Our aim was to describe the outcome measures used in dementia and mild cognitive impairment (MCI) intervention studies, with particular interest in those evaluating patient-centred outcomes of functional performance and quality of life. Methods: We performed a focused review of the literature with multiple embedded checks of internal and external validity. We used the Cochrane Dementia and Cognitive Improvement Group’s register of dementia studies, ALOIS. ALOIS was searched to obtain records of all registered dementia and MCI intervention studies over a 10-year period (2004–2014). We included both published and unpublished materials. Outcomes were categorised as cognitive, functional, quality of life, mood, behaviour, global/disease severity and institutionalisation. Results: From an initial return of 3271 records, we included a total of 805 records, including 676 dementia trial records and 129 MCI trial records. Of these, 78 % (630) originated from peer-reviewed publications and 60 % (487) reported results of pharmacological interventions. Cognitive outcomes were reported in 70 % (563), in contrast with 29 % (237) reporting measures of functional performance and only 13 % (102) reporting quality of life measures. We identified significant heterogeneity in the tools used to capture these outcomes, with frequent use of non-standardised tests. Conclusions: This focus on cognitive performance questions the extent to which intervention studies for dementia are evaluating outcome measures which are relevant to individual patients and their carers. The heterogeneity in measures, use of bespoke tools and poor descriptions of test strategy all support the need for a more standardised approach to the conduct and reporting of outcomes assessments. [ABSTRACT FROM AUTHOR]

Background: Literature on the timing of rabbit antithymocyte globulin (rATG) induction and its effects on kidney transplant outcomes is limited. The manufacturer recommends that the first dose be given intra-operatively, however this may present clinical practice risks and challenges. Our objective was to assess the impact of the timing of the first dose of rATG on kidney transplant outcomes., Methods: Incident kidney transplant recipients (KTR) from January 2002 to December 2009 receiving the first dose of rATG post-operatively (Post, n = 353) or before reperfusion (Pre, n = 124) were evaluated. Outcomes assessed included eGFR at 1-year, delta eGFR (12 versus 1 month), and incidence of biopsy-proven acute rejection, graft loss, death, and a composite of the time-to-event outcomes. The impact of timing on outcomes was adjusted for potential confounders and assessed using linear and Cox regression models., Results: Among 435 KTR surviving with function to 12 months post-transplant, there was no significant difference in mean estimated glomerular filtration rate or eGFR (55.0 versus 56.7 mL/min, P = 0.46) and delta eGFR (1.8 versus 0.3 mL/min, P = 0.40) in Post versus Pre groups, respectively. At a median follow-up of 3 years, the composite endpoint (time to first biopsy-proven acute rejection, graft loss, or death) was similar by timing group (adjusted HR = 0.94; 95% CI: 0.58, 1.53, P = 0.81) in the total study population., Conclusions: Timing of rATG had no appreciable impact on clinically relevant endpoints in this study cohort. These results support consideration of more flexible timing of the first dose of rATG induction in KTR.