Template for multicellular RCT (Mosaic)

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Description: The cellular trial model offers the ability to carry out a mosaic of "mini-trials" during a single patient journey, either sequentially or concurrently.

Publet Introduction:

Standard randomised controlled trial methodology has a number of well-known shortcomings. Traditional trials typically evaluate a single intervention (or one combination regime) because possible interactions between therapies in complex regimens would have unpredictable clinical effects, and would make it difficult to statistically separate out the cause of any benefits or harms. The classical stepwise approach to cancer trials, for example, has developed in which multiple generations of regimens in which dosages or other experimental conditions are systematically varied over trials. As a result, however, a full series of evaluations can take many years to complete.  

A specific form of this problem has arisen in medical informatics which, if it can be solved, might contribute to addressing the more general problem. In the development and introduction of some computer-based clinical system, such as an electronic patient record or a decision support system the many different services offered by the system can interact in complex and unpredictable ways, either directly or indirectly by changing ways of working. As a result it may be difficult to determine whether any benefits or harms that arise as a result of a new service are caused by the new system, or are an artifact or a side-effect of other changes introduced at the same time.

The effect of this problem is that if rigorous evaluation of the new service is required its functionality must be very narrowly constrained to permit comparison between a limited number of interventions.

This is a very unsatisfactory position for all concerned, particularly as it is generally accepted that multi-functional IT systems are very promising tools for improving clinical effectiveness while containing costs, but the many different services and functions they provide impact many existing organisations, work patterns and individuals but the individual effects cannot be separated out.

The cellular trial model offers the ability to carry out a mosaic of "mini-trials" during a single patient journey, either sequentially or concurrently. Each patient may be recruited into any of the mini-trials which are available. These can be run independently of other trials or taking account of the results for the patient having participated in a previous mini-trial. This publet is an example of a mosaic template containing 3 interconnected mini trials. etween the with/without service conditions. This is to be contrasted with the common situation where a healthcare provider or an IT supplier introduces a large-scale application then evaluation tends to focus on gross measures of clinical or service impact or, more often than not, no systematic trial is carried out at all.


  Information
Guideline objectives

A modular trial framework for complex interventions 

Target setting Clinical research
Target users Clinical researchers
Overview

A modular framework for complex interventions, in which people recruited into trials of informatics systems can follow individualised pathways through separate trial "cells" to evaluate multiple interventions and their outcomes as they progress through their journey. 

Provenance 7.No provenance has been assigned (default value)
Management
  • Author: John Fox
  • Release date:
  • Status: Draft - Under Review
  • History: Edited on 10/9/2014
Safety case
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