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