A feasibility study for a trial investigating the treatment of sarcoidosis-associated fatigue with methylphenidate

Atkins, Christopher (2018) A feasibility study for a trial investigating the treatment of sarcoidosis-associated fatigue with methylphenidate. Doctoral thesis, University of East Anglia .

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Abstract

Objectives - The research objective was to determine the feasibility of performing an appropriately-powered study investigating the use of methylphenidate for sarcoidosis-associated fatigue.

Methods - The Fatigue and Sarcoidosis – Treatment with Methylphendiate (FaSTMP)
feasibility study was undertaken to compare methylphenidate with an identical
placebo in a double-blind, randomised, parallel-arm study. Participants had the
opportunity to discuss their perspectives on the study in post-trial focus groups.

Alongside FaST-MP, further work was undertaken to determine future study design.
Activity monitors were piloted to determine the preferred device in patients with
sarcoidosis. Quality of life measures were compared using data from a cohort of
patients with sarcoidosis to understand the relationship between clinical outcomes.

Findings – Participant recruitment to the FaST-MP study was lower than expected
(22 participants) but retention was high (100%) and the medication appeared welltolerated
and safe. No statistical difference in change in fatigue scores was seen
between the methylphenidate and placebo arms, although both groups showed
improvement from baseline fatigue scores. Participants reported a positive
experience of the trial from focus group discussion but raised concerns relating to
the fatigue outcomes used and the frequency with which fatigue was measured.

Comparison of quality of life questionnaires identified differences between two
commonly used measures which may influence questionnaire choice in future
studies investigating sarcoidosis-associated fatigue.

Conclusion - Designing a full phase III study to investigate the clinical efficacy of
methylphenidate for sarcoidosis-associated fatigue appears feasible, although
future study design must consider how to best reflect “usual care”, as well as the
optimal outcome measures within such a study.

Item Type: Thesis (Doctoral)
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
Depositing User: Zoe White
Date Deposited: 22 May 2019 11:29
Last Modified: 22 May 2019 11:29
URI: https://ueaeprints.uea.ac.uk/id/eprint/71094
DOI:

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