Improving adverse event reporting in rehabilitation trials for people with Multiple Sclerosis

Background

It is essential to assess harms as well as benefits of investigational treatments to provide a robust evidence base. This is underlined by recent updated CONSORT guidelines for the reporting of harms [1]. Yet, reporting of harms has been found to be inadequate generally and is an issue for both drug and non-pharmacological trials [2].

The use of appropriate statistical methodology for assessment of harms, and language for communicating them to both scientific and lay audiences, may also be lacking [3-4]. All of these issues result in concern over the integrity of trial findings and ultimately the safety of patients as well as trial participants. With particular regard to trials in Multiple Sclerosis (MS), it has been reported that conclusions of exercise trials are often limited by inconsistencies in reporting of safety/ adverse events [5] and preliminary work indicates this extends to rehabilitation trials [6], perhaps because of the added complexities of a neurological condition whereby the disease course is typically progressive, and day-to-day symptoms unpredictable.

What the studentship will encompass

This project aims to describe and address these issues by developing and promoting tailored guidance on adverse event reporting for researchers working in MS rehabilitation trials. The studentship will encompass 3 work packages (WP1-3). WP1 will involve a review of the reporting of adverse events (AE's) in MS rehabilitation trials, with the aim of identifying common practices and limitations in how adverse events are currently collected, classified, and reported (including the use of appropriate statistical methodology).

WP2 will continue by investigating the barriers and facilitators to implementation of existing guidance. It will further explore issues from a patient perspective, through one-to-one interviews of people with MS who have previously participated or who are currently participating in trials, exploring their experience of AE reporting. WP3 will utilise the data gathered in WP1 and WP2 to inform an international multi-perspective Delphi study.

This will aim to gain consensus on key issues, likely to include: methods for collecting and ranking AE data; inclusion (or not) of existing MS symptoms (which can fluctuate on a day-to-day basis); and core AE components which should be assessed in all MS rehabilitation trials so that findings can be combined and compared. Key stakeholders will include patient representatives, journal editors, and experts in MS rehabilitation trials.

This will culminate in the development of recommendations tailored to MS rehabilitation trials, aligned with the latest SPIRIT/CONSORT guidelines (including statistical analysis and visualisation of harms data).