scholarly journals Estimating psychological treatment effects from a randomised controlled trial with both non-compliance and loss to follow-up

2003 ◽  
Vol 183 (4) ◽  
pp. 323-331 ◽  
Author(s):  
G. Dunn ◽  
M. Maracy ◽  
C. Dowrick ◽  
J. L. Ayuso-Mateos ◽  
O. S. Dalgard ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Psychological Intervention ◽  
Psychological Treatment ◽  
Causal Effect ◽  
Controlled Trial ◽  
Loss To Follow Up ◽  
Average Causal Effect ◽  
Trial Subject ◽  
Randomised Controlled

BackgroundThe Outcomes of Depression International Network (ODIN) trial evaluated the effect of two psychological interventions for the treatment of depression in primary care. Only about half of the patients in the treatment arm complied with the offer of treatment, prompting the question: ‘what was the effect of treatment in those patients who actually received it?’AimsTo illustrate the estimation of the effect of receipt of treatment in a randomised controlled trial subject to non-compliance and loss to follow-up.MethodWe estimated the complier average causal effect (CACE) of treatment.ResultsIn the ODIN trial the effect of receipt of psychological intervention (an average of about 4 points on the Beck Depression Inventory) is about twice that of offering it.ConclusionsThe statistical analysis of the results of a clinical trial subject to noncompliance to allocated treatment is now reasonably straightforward through estimation of a CACE and investigators should be encouraged to present the results of analyses of this type as a routine component of a trial report.

scholarly journals Feasibility study on recruitment in general practice for a low back pain online information study (part of the ADVIN Back Trial)

2020 ◽  
Vol 13 (1) ◽  
Author(s):  
Allan Riis ◽  
Michael Skovdal Rathleff ◽  
Jan Hartvigsen ◽  
Janus Laust Thomsen ◽  
Tamana Afzali ◽  
...  
Keyword(s):  
General Practice ◽  
Low Back Pain ◽  
Back Pain ◽  
Randomised Controlled Trial ◽  
Web Application ◽  
Controlled Trial ◽  
Low Back ◽  
Loss To Follow Up ◽  
Randomised Controlled

Abstract Objective In a future full-scale randomised controlled trial, we plan to compare satisfaction with a standard website versus satisfaction with a participatory driven web-application. The participatory driven web-application may facilitate the delivery of targeted evidence-based advice and information to patients with low back pain in general practice (ClinicalTrials.gov Identifier: NCT03088774). This feasibility study is intended to inform a future randomised controlled trial. The aim is to report on the lessons learned from recruitment to report on reasons for loss to follow-up. Results We recruited 12 women and 8 men from two general practices with each practice recruiting for 3 months. Full follow-up data was available in only three patients (15%). Based on the high loss to follow-up, we do not consider it feasible to conduct the full-scale confirmatory trial as planned. Modifying inclusion criteria to include only patients expressing an interest in using online health information or randomising patients directly at the general practice, supporting them in accessing the web-application, and letting patients respond with their immediate satisfaction may improve the speed of recruitment and follow-up rates. Furthermore, the participatory driven web-application can be included in a larger multi-faceted intervention, making the combined intervention seem more relevant to study participants.

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