eprintid: 10108228
rev_number: 21
eprint_status: archive
userid: 608
dir: disk0/10/10/82/28
datestamp: 2020-08-21 15:14:42
lastmod: 2021-12-18 23:44:59
status_changed: 2020-08-21 15:14:42
type: article
metadata_visibility: show
creators_name: Jacobsen, P
creators_name: Wood, L
title: Risk of contamination when planning psychological therapy trials can be assessed using a simple framework
ispublished: pub
divisions: UCL
divisions: B02
divisions: C07
divisions: D79
keywords: Clinical trial, Clinical trial protocol, Psychotherapy, Registries, Research design, Research methodology
note: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
abstract: Objectives:
The objective of this study was to develop and pilot a standard framework that could be used to assess risk of contamination in psychological therapy trials, at the protocol development stage.

Study Design and Setting:
We developed and piloted a risk of contamination framework on a sample of 100 psychological therapy trial protocols registered on the International Standard Randomised Controlled Trial Number (ISRCTN) registry (www.isrctn.com). We assessed all protocols as being low or high risk via three possible sources of contamination: 1) participants in the control arm, 2) participants in the intervention arm, 3) therapists in the intervention arm.

Results:
Overall, we found that the risk of contamination across all three sources was low for most studies (86 of 100 trial protocols; 86%). We identified 14 studies that had a potentially high risk for contamination. Most of these (N = 10) were identified as risk of contamination arising from a therapist in the intervention arm.

Conclusion:
The risk of contamination framework we piloted in this study could be a helpful tool for researchers aiming to identify and manage risk of contamination in their trial protocol development. We found that the risk of contamination was relatively low in the psychological therapy trials we sampled for this study, as measured by our framework, and could usually be mitigated through reasonable adjustments to the study design.
date: 2020-08
date_type: published
official_url: https://doi.org/10.1016/j.jclinepi.2020.04.005
oa_status: green
full_text_type: other
language: eng
primo: open
primo_central: open_green
verified: verified_manual
elements_id: 1780923
doi: 10.1016/j.jclinepi.2020.04.005
pii: S0895-4356(19)31109-6
lyricists_name: Wood, Lisa
lyricists_id: LJWOO92
actors_name: Austen, Jennifer
actors_id: JAUST66
actors_role: owner
full_text_status: public
publication: Journal of Clinical Epidemiology
volume: 124
pagerange: 8-15
event_location: United States
citation:        Jacobsen, P;    Wood, L;      (2020)    Risk of contamination when planning psychological therapy trials can be assessed using a simple framework.                   Journal of Clinical Epidemiology , 124    pp. 8-15.    10.1016/j.jclinepi.2020.04.005 <https://doi.org/10.1016/j.jclinepi.2020.04.005>.       Green open access   
 
document_url: https://discovery.ucl.ac.uk/id/eprint/10108228/3/Wood_Jacobsen%20%26%20Wood%20%282020%29%20Framework%20to%20assess%20risk%20of%20contamination_AAM.pdf