UNLOCK
What is UNLOCK?
UNLOCK (Uncovering and Noting Long-term Outcomes in COPD and asthma to enhance Knowledge) is an international collaboration between primary care researchers to coordinate and share datasets of relevant diagnostic and follow-up variables for COPD and asthma management in primary care. It was set up by members of the International Primary Care Respiratory Group. The protocol summary was published in the Primary Care Respiratory Journal in 2010 and the report of the findings to 2018.
The UNLOCK Group currently includes members from 15 countries: Sweden, Spain, Ukraine, Canada, Greece, UK, Netherlands, Norway, Australia, USA, Portugal, Germany, India, Uganda and Chile.
What is UNLOCK for?
The IPCRG Research Need Statements identified the need for evidence to underpin the primary care approach to diagnosis, assessment and broad management strategies.[1],[2]This evidence is required to address current concerns including variations in care and outcomes, the difference between the results of clinical trials and real outcomes in primary care and the need for clinical guidelines that are relevant and useful for primary care. Furthermore, there is growing consensus that additional evidence is needed on the process of translating basic scientific discoveries into clinical practice, known as the "bench to bedside continuum". [3]
The primary purpose of UNLOCK is, therefore, to contribute to meeting these research needs through the evaluation of the burden of disease (symptoms, limitations and exacerbations), the natural history of disease, treatment and follow-up, and co-morbidities in unselected primary care populations from diverse contexts. The unique value of UNLOCK is that data is drawn from primary care databases so there is the potential for longitudinal as well as cross-sectional studies. In addition, as they are primary care populations there is the potential to consider multiple morbidity. Moreover, because there are already 15 countries involved, data can be drawn from a variety of contexts.
How does UNLOCK work?
Participants from leading universities and research institutes across 15 countries collaborate in the UNLOCK Group to progress UNLOCK studies. The UNLOCK Group:
- Discusses and agrees research questions
- Develops and approves study protocols
- Publishes protocols in npjPrimary Care Respiratory Medicine
- Registers protocols on the ENCePP registry[4]
- Discusses and challenges emerging findings
- Publishes findings in peer-reviewed journals
- Presents findings nationally and internationally
UNLOCK members provide relevant data from their existing primary care datasets for analysis to answer relevant research questions in one of two ways, depending on the ethical approval and data protection requirements of their own datasets: either they analyse they own data using agreed variables and provide this analysis to the lead researcher; or they provide the data to the lead researcher undertaking the study for centralised analysis. Each member maintains their own database and data is not kept in a merged form in order to maintain the integrity of individual datasets.
Analysis undertaken depends on specific research questions and usually includes includes comparison of patient characteristics (age, gender, smoking status, socio-economic status) and disease severity (FEV1%, exacerbations, quality of life, comorbidities) and retrospective cross-sectional analysis in primary care datasets from different UNLOCK countries.
The UNLOCK Group has been meeting twice a year in person to define research questions and discuss emerging findings. In between meetings, virtual discussions take place. The work of the UNLOCK Group was supported by a researcher and a project manager until the end of the funded period. Now individual studies are continuing, in particular the Greek UNLOCK project, funded by IPCRG. As at September 2020, two publications were in press.