Large healthcare database research informs clinical and payment decisions and improves the quality of healthcare. Capacity to use data contained in large healthcare databases has increased exponentially, however, much of the evidence from large healthcare databases lacks transparency in reporting, making it challenging to assess the reproducibility and scientific robustness of findings. This protocol is part of a series of study replications for the REPEAT Initiative, a project which involves systematically sampling published studies to review and replicate. The goal is to understand what information is missing in public reporting that prevents replication of findings. The outcome of the REPEAT project will be an evaluation of frequency of reporting specific study methods and the impact on reproducibility. Our results will inform policies/guidelines on reporting for database studies. This protocol focuses on replication of one sampled study: 'Rising burden of gout in the UK but continuing suboptimal management: a nationwide population study?' by Kuo and colleagues. The Kuo paper describes how common gout and treatment for gout is in the UK general population between 1997 and 2012. We will review and replicate the study based on methods reported in the publication and appendices.
This objective of this protocol is to replicate the study: 'Rising burden of gout in the UK but continuing suboptimal management: a nationwide population study?' by Kuo et al. based on methods reported in the publication and appendices. We have created a checklist of specific study implementation parameters based on a comprehensive catalogue outlined in a consensus paper endorsed by the International Society of Pharmacoepidemiology and the International Society of Pharmacoeconomics and Outcomes research. We will start by reviewing the paper to identify which parameters from the catalogue are reported. We will then replicate the study population and analyses based on the study design and implementation parameters extracted during review. The Kuo paper describes adherence to urate lowering treatment in the UK general population with prevalent of incident gout between 1997 and 2012. We will focus on replicating the outcome of adherence to urate lowering treatment for prevalent and incident gout patients over this time period. Adherence in prevalent gout patients will be measured using proportion of days covered (PDC). PDC will be calculated as the proportion of days on which a patient had available prescriptions for urate lowering treatment over intervals defined as the period from the latest of registration date or 1 January to the earliest of transfer-out, death date or 31 December in each calendar year. For incident gout patients, adherence will be measured as percentage of incident gout patients treated with urate lowering treatment at 6 months and 1 year after diagnosis.
Adherence to urate-lowering treatment (ULT) medications.
Shirley Wang - Chief Investigator - Harvard University
Elisabetta Patorno - Collaborator - Brigham & Women's Hospital
Jessica Franklin - Collaborator - Brigham & Women's Hospital
Krista Huybrechts - Collaborator - Brigham & Women's Hospital
Sebastian Schneeweiss - Collaborator - Aetion, Inc
Dorothee Bartels - Chief Investigator - Boehringer-Ingelheim Germany
Andrea Meyers - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc