Science should be replicable. The methods section in publications describe how research is conducted. This protocol is part of the REPEAT Initiative, a project that is attempting to replicate a sample of published research studies using information provided in the publications. REPEAT is focused on studies using observational healthcare data from electronic health records or administrative claims to generate scientific evidence. The goal is to better understand what information is missing in publications that prevents replication of the published results. This project will evaluate how commonly important decisions in research process design are not clearly reported as well as how lack of impacts ability to replicate study findings. Our results will inform future policies and guidelines for reporting on healthcare database research.
This protocol focuses on one sampled study: Cardiovascular risks in smokers treated with nicotine replacement therapy: a historical cohort study by Dollerup and colleagues. by Dollerup and colleagues. The Dollerup paper aimed to evaluate cardiovascular events and survival among individuals who attempted to stop smoking with the support of nicotine replacement therapy (such as nicotine patches or sprays) compared with those aided by only advice on how to stop smoking in the general population of the United Kingdom (UK) between 2000 and 2009. We will replicate this study based on methods reported in the publication.
This objective of this protocol is to replicate the study: Cardiovascular risks in smokers treated with nicotine replacement therapy: a historical cohort study by Dollerup 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 Dollerup paper evaluates cardiovascular events and survival among individuals who attempted smoking cessation with the support of NRT (nicotine replacement therapy) compared with those aided by smoking cessation advice only between 2000-2009. We will focus on replicating the outcome of ischemic heart disease (IHD) events in individuals who attempted smoking cessation over this time period. We will focus on replicating the baseline cohort characteristics and the adjusted hazard ratio for IHD using a Cox proportional hazards model.
CVD events and survival among individuals who attempted smoking cessation
Jeremy Rassen - Chief Investigator - Aetion, Inc
Shirley Wang - Corresponding Applicant - Harvard University
Elisabetta Patorno - Collaborator - Brigham & Women's Hospital
Elizabeth Garry - Collaborator - Aetion, Inc
Jessica Franklin - Collaborator - Brigham & Women's Hospital
Krista Huybrechts - Collaborator - Brigham & Women's Hospital
Sebastian Schneeweiss - Collaborator - Aetion, Inc