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Pharmacogenetic Passport (PGXP)
The Pharmacogenetic Passport (PGXP) study is an additional assessment, performed in adult Lifelines participants in collaboration with the UMCG Department of Genetics.
The main aim of the PGXP project was to improve the understanding of requirements for returning PGx passports (in a smartphone application) to individuals (in this case: Lifelines participants) in a responsible way, such that the use of information by PGx passport recipients and their healthcare professionals is optimized.
The following research questions were addressed:
What are biobank participants’ attitudes towards (a) (pharmaco)genetic information (b) PGx passports in general, © the disclosure of PGx passports within this research context (including the unexpected offer of disclosing PGx passports as a secondary research finding/reward for participation and the design in which PGx passports are disclosed only directly to them and not to their healthcare providers) and (d) towards disclosing the information by means of a smartphone application (only)?
What are biobank participants’ expectations regarding (a)the use of the PGx passport by themselves and their healthcare providers and (b) the allocation of responsibilities between themselves and their healthcare professionals within the pilot study?
To what extent do participants understand the information (a) accompanying the offer of their PGx passport (i.e., to what extent are participants capable of making an informed decision) and (b) disclosed within the actual PGx passport disclosed to them after acceptance?
What are participants’ reasons/motives for accepting/rejecting disclosure of their PGx passport (in the smartphone application)?
What are participants’ intentions on sharing the information in the PGx passport with their healthcare providers?
What is the psychological impact (including anxiety and worry ) of accepting/rejecting the offer to receive a personal PGx passport and of reading the information disclosed in the PGx passport?
How do participants regard the usability of the smartphone application used for disclosing the PGx passport?
What is the uptake, in terms of (a) installing the application, (b) giving consent to receiving the PGx passport, © reading the information provided, and (d) sharing the information provided with their own healthcare professionals (when appropriate)?
What are the determinants of (the different aspects of) uptake? Potential determinants evaluated are sociodemographic characteristics, health status and use of medication, the degree of understanding the information in the PGx passport, health literacy, attitudes towards the PGx passport and the disclosure of it within this research context, perceived barriers, facilitators, and benefits of sharing the PGx passport.
Protocol
, using psychological/behavioral theories and models/frameworks such as the Theory of Planned Behavior (Azjen,1985)
Participants underwent ultra-low-dose CT scanning of lungs and heart with third-generation dual-source CT (SOMATOM Force, Siemens). Scanning was performed during suspended inspiration, according to the standard vendor recommended protocol, with tube current adjusted automatically by the system for body size based on the scout images. The scout images were followed by a CT scan of the lungs in inspiration, and, in a subset of 100 participants per 5-year age/gender category, also in expiration. The latter was performed to determine normal values for expiratory lung density.
To obtain a CT scan of the heart at the moment that the movement of the coronary arteries is the lowest, participants were fitted with ECG electrodes by CT personnel. The software of the CT scanner decided what the best moment is during a regular heartbeat to acquire the CT data of the heart, and subsequently the CT scan of heart was obtained.
The primary end-point was the establishment of reference values of:
lung density
bronchial wall thickness
vascular calcification
lung nodules
Participants with a lung nodule between 100-300 mm3 (~5,4% of all scanned participants) were invited for a repeat CT scan after 3-4 months for scientific purposes, to evaluate natural evolution of lung nodules in the general population.
Subcohort
Imalife ran from 2017 to 2022. The assessments were performed in ~12.000 Lifelines participants of 45+ years who completed a pulmonary function test.
To ensure sufficient participants in the older age groups, selection criteria were later adjusted to 60+ and, in the final phase, 75+.
Publications using Imalife data
Variables
A precise list of variables derived from CT-scans will be described later.