As part of efforts to improve study design, the use of outcome measures in randomized controlled trials (RCTs) in traumatic brain injury (TBI) is receiving increasing attention. This review aimed to assess how clinical outcome assessments (COAs) have been used and reported in RCTs in adult TBI. Systematic literature searches were conducted to identify medium to large (n ≥ 100) acute and post-acute TBI trials published since 2000. Data were extracted independently by two reviewers using a set of structured templates. Items from the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement and CONSORT patient-reported outcomes (PROs) extension were used to evaluate reporting quality of COAs. Glasgow Outcome Scale/Extended (GOS/GOSE) data were extracted using a checklist developed specifically for the review. A total of 126 separate COAs were identified in 58 studies. The findings demonstrate heterogeneity in the use of TBI outcomes, limiting comparisons and meta-analyses of RCT findings. The GOS/GOSE was included in 39 studies, but implemented in a variety of ways, which may not be equivalent. Multi-dimensional outcomes were used in 30 studies, and these were relatively more common in rehabilitation settings. The use of PROs was limited, especially in acute study settings. Quality of reporting was variable, and key information concerning COAs was often omitted, making it difficult to know how precisely outcomes were assessed. Consistency across studies would be increased and future meta-analyses facilitated by (a) using common data elements (CDEs) recommendations for TBI outcomes and (b) following CONSORT guidelines when publishing RCTs.

With an ageing population there is a move towards the use of assisted living technologies (ALTs) to provide social care and health care services, and to improve service processes. These technologies are at the forefront of the integration of health and social care. However, economic evaluations of ALTs, and indeed economic evaluations of any interventions providing both health benefits and benefits beyond health are complex. This paper considers the challenges faced by evaluators and presents a method of economic evaluation for use with interventions where traditional methods may not be suitable for informing funders and decision makers. We propose a method, combining economic evaluation techniques, that can accommodate health outcomes and outcomes beyond health through the use of a common numeraire. Such economic evaluations can benefit both the public and private sector, firstly by ensuring the efficient allocation of resources. And secondly, by providing information for individuals who, in the market for ALTs, face consumption decisions that are infrequent and for which there may be no other sources of information. We consider these issues in the welfarist, extra-welfarist and capabilities frameworks, which we link to attributes in an individual production model. This approach allows for the valuation of the health component of any such intervention and the valuation of key social care attributes and processes. Finally, we present a set of considerations for evaluators highlighting the key issues that need to be considered in this type of economic evaluation.