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Statistics Seminar - A taxonomy of designs for randomised optimisation trials of therapist-led interventions: A systematic overview of methods

Dates:5 February 2025
Times:14:00 - 14:50
What is it:Seminar
Organiser:Department of Mathematics
Who is it for:University staff, External researchers, Current University students
Speaker:Dr. Rebecca Walwyn
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  • In category "Seminar"
  • In group "(Maths) Probability and statistics"
  • By Department of Mathematics

Dr. Rebecca Walwyn University of Leeds

Abstract

Background: Therapist-led interventions such as psychotherapy are complex, delivered by therapists to individuals, and commonly evaluated in randomised trials. How the randomisation incorporates the therapist is pivotal to the design, yet little is known about how this is done in practice. Aim: To introduce a taxonomy of designs used in randomised trials and to summarise the practical constraints reported. Methods: Systematic methods overview of the designs reported and discussed in randomised trials in general medical journals and specialist journals from 1980 to 2022. Searches in MEDLINE, EMBASE, PsycInfo were conducted in November 2022. Protocol or main results papers that evaluated an intervention delivered at least in part by a therapist to patients in a randomised trial were eligible, with no restriction on therapist profession or patient condition. Results: 821 papers were screened, with 474 meeting eligibility criteria, relating to 459 trials. Of these, 91 (20%) evaluated a group-based therapy. Of the 368 that did not, 58 (16%) included therapists as a stratification factor, a treatment factor, or a unit in the randomisation. We will set out 10 of the possible trial designs, broadly based on these 58 historical examples, using diagrams to clearly describe the randomisation. Common constraints on the trial design included therapist availability at the point of randomisation, therapist turnover, and variability in caseloads. Discussion: A wide range of trial designs are used in practice. The therapist is included as a factor in the randomisation in a sizeable minority. Guidance is needed, addressing common practical constraints.

Speaker

Dr. Rebecca Walwyn

Organisation: Univ. of Leeds

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Madhu Bhattacharjee

madhu.bhattacharjee@manchester.ac.uk

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