Evaluation of the implementation and content of a core outcome set for medicines management interventions for people living with dementia: a structured literature review study

Abstract Introduction A core outcome set (COS) represents the minimum set of outcomes that should be reported in all trials related to a specific healthcare area.[1] In 2019, a COS for medicines management interventions for people living with dementia (PLWD) was published.[2] This COS included 21 outcomes with priority given to the seven highest ranking outcomes.[2] However, utilisation of this COS and whether its content requires revision/updating should be evaluated. Aim To assess implementation of the existing COS and its current content using a structured literature review, with a view to updating and refining the included outcomes.[2] Methods Ovid MEDLINE, Embase, PsycINFO, CINAHL, Cochrane CENTRAL, and Web of Science, Research Registry, International Clinical Trials Registry Platform, and ClinicalTrials.gov were searched from 2016 (the cutoff date of the previous review informing the content of the current COS[2]) until April 2025 using search terms to identify outcomes being used in clinical trials since the original COS was developed.[2] Randomised controlled trials (RCTs) or RCT protocols targeting medicines management interventions for PLWD and/or carers, and published in English were included. Information was extracted from included studies encompassing author names, country of study, description of intervention and control groups, and outcomes measured. Extracted outcomes were compared with the content of the COS.[2] Findings were summarised using frequencies and presented in tables. Results In total, 553 articles were retrieved. Following removal of duplicate and non-English records, titles and abstracts of 356 records were screened, leaving 42 articles for full-text screening. Nineteen articles relating to 13 trials and six trial protocols were identified; most (n = 14) were published after publication of the COS. Although some of them used outcomes included in the COS, none of them explicitly cited the COS and several non-COS outcomes were used in the studies. Table 1 presents an overview of outcomes and their use in identified studies. Conclusion This study highlighted poor implementation of the existing COS in recent clinical trials. The main study limitation was the lack of standardised outcome definitions across studies and how this may have affected comparison with COS outcomes. This study highlights the need to update/revise the COS, explore reasons for poor implementation, and promote its uptake.