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Abstract 

Cluster randomised trials (CRTs) often face issues with missing data and treatment non-adherence. Guidelines such as CONSORT require that the numbers of clusters and individuals randomised, receiving treatment and analysed are reported, while newer guidelines go further (see for example the ICH 9 addendum on estimands), suggesting that an adherence-adjusted estimand is reported alongside an intention-to-treat estimate. For both analyses, missing data in covariates and outcome need to be handled appropriately as failure to do so can introduce bias in treatment effect estimates, leading to invalid inferences.

Multiple imputation has become a popular method to handle missing data, and instrumental variables methods can be used to obtain adherence-adjusted average treatment estimates (CACE). Both of these statistical techniques should reflect the hierarchical nature of CRT data.

In this talk, I will present multilevel multiple imputation for continuous and binary data, and then

present two approaches to obtain CACE for CRTs: (1)  cluster-level analysis two-stage least square method, with inferences at the cluster level, and (2) mixture models with random effects for individual level CACE.

I will illustrate these methods by re-analysing a CRT in UK primary health settings. The OPERA study trial, which studied the effect of a physiotherapist-led exercise intervention on depression and physical health in elderly residents of nursing home.

Forthcoming events

Infectious Disease Seminar Series: Hepatitis B diagnosis, prevention and treatment: laboratory approaches to the elimination agenda

Monday, 06 February 2023, 1pm to 2pm @ BDI Seminar Room LG 0-1, Old Road Campus, Headington, OX3 7LF

Ethox seminar- Feminist-Ethical Perspectives on Digital (Health) Technologies

Tuesday, 14 February 2023, 11am to 12.30pm @ Big Data Institute, Lower Ground Seminar Room 1, Oxford Population Heath, University of Oxford

Richard Doll Seminar - E-Freeze trial results

Tuesday, 14 February 2023, 1pm to 2pm @ Richard Doll Lecture Theatre, Richard Doll Building, Old Road Campus, OX3 7LF

Infectious Disease Seminar Series: Informing on Neisseria gonorrhoeae treatment and management through pathogen genomics

Monday, 20 February 2023, 1pm to 2pm @ BDI Seminar Room LG 0-1, Old Road Campus, Headington, OX3 7LF