Incidence of corticosteroid related adverse events in inflammatory musculoskeletal conditions

Study type
Protocol
Date of Approval
Study reference ID
15_200
Lay Summary

Corticosteroids are often used by doctors in primary care to treat a wide range of conditions, including inflammatory disorders such as rheumatoid arthritis, polymyalgia rheumatica, inflammatory bowel disease, and asthma. Although effective, these steroids have been linked in previous research with a range of adverse outcomes such as diabetes, obesity, and hypertension. However these studies have generally used select patient groups (for example, including only patients in hospital), followed patients for only a short time period, or had limitations in their approach to analysis. We aim to use routinely collected medical record data to examine the relationship of steroid use with new onset of diabetes, hypertension, obesity, cataracts and glaucoma within patients with rheumatoid arthritis and polymyalgia rheumatic – two disorders commonly treated with steroids. We will assess whether increased dosage or duration of time on corticosteroids increases the risk of future development of these conditions. An important part of the study is to develop the best approaches to analysis to most accurately model the risk of adverse outcomes using routine primary care data.

Technical Summary

The objective is to assess the relationship of prescribed prednisolone with incidence of diabetes, hypertension, obesity, cataracts and glaucoma within patients with rheumatoid arthritis (RA) and polymyalgia rheumatica (PMR). We will identify patients with a diagnosis of RA or PMR between 2000-2010 and with a new prescription of prednisolone and follow them for up to 15 years to assess incidence of the outcome morbidities, comparing by duration and dosage of prednisolone, and to RA and PMR patients without a prescription of prednisolone. The study includes a substantial methodological aspect as care needs to be taken when using observational data to estimate treatments effects because of the non-randomized nature of the groups. Treatment decisions will be influenced by pre-treatment characteristics (covariates) which may relate to subsequent outcome. We will use propensity score methodology to address such confounding by indication. The approach involves calculating, and incorporating into analyses, the propensity (likelihood) of each patient to receive steroids or a particular dosage of steroids, given their observed covariates. We will explore use of propensity scores when treatment (e.g. prednisolone dosage) varies over time, or when there are missing information on observed covariates, and address the potential impact on our findings of unmeasured patient characteristics.

Collaborators

Milica Bucknall - Chief Investigator - Keele University
Kelvin Jordan - Corresponding Applicant - Keele University
Christian Mallen - Collaborator - Keele University
Samantha Hider - Collaborator - Keele University
Trishna Rathod-Mistry - Collaborator - Keele University

Linkages

Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation