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Table 1 List of inclusion and exclusion criteria for this systematic review. RCT - Randomised Controlled Trial

From: A systematic review of simulation studies which compare existing statistical methods to account for non-compliance in randomised controlled trials

 

Inclusion criteria

Exclusion criteria

Publication type

Peer-reviewed methodological papers whose focus is to compare two or more existing methods under a sufficient simulation study.

Non-peer reviewed articles, books or book chapters, theses or other grey literature such as conference proceedings.

Focus

The methodological topic of interest is non-compliance to the randomised intervention, which may be by participants in the intervention or control groups. This compliance could be described as all-or-nothing or time varying/partial. Some papers refer to non-adherence, but we are considering these terms to be interchangeable in this paper.

Papers that focus on issues such as missing data or the combination of these issues with non-compliance.

Papers whose focus is a novel method rather than comparison of existing methods (e.g., that describe/reference a current method and propose an extension to it or propose a new method).

Setting

The methods considered are explicitly applied to account for non-compliance in the setting of a superiority RCT.

Papers that focus on an observational setting.

Papers that consider a non-inferiority or equivalence setting.

Methods based on aggregated data such as meta-analysis.

Simulation study

A simulation study was defined as ‘sufficient’ based on the following criteria:

o The simulation study clearly states its objectives and gives a description of how the simulation was conducted/the nature of the simulated data.

o The simulation study compares at least two existing methods that aim to account for non-compliance and estimate a point estimate of the intervention effect.

o Existing methods refers to those that have not been proposed in the paper of interest and the authors have referenced previous work when describing the method.

o The authors consider several non-compliance scenarios, such as varying the proportion or type of non-compliance.

o Amongst performance measures, at least the bias of methods is reported or can be easily deduced.

 

Publication date

Papers published from databases inception to 30th November 2022.

 

Publication language

Papers published in the English language.

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