pgxp
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| 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 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: | + | The following aspects were addressed: |
| - | - What are biobank participants’ attitudes towards (a) (pharmaco)genetic information (b) PGx passports in general, (c) 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)? | + | - **attitudes** towards (a) (pharmaco)genetic information (b) PGx passports in general, (c) the disclosure of PGx passports within this research context 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? | + | - **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? | + | - **understanding of 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)? | + | - **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? | + | - **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? | + | - **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? | + | - **usability of the smartphone app** 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, (c) reading the information provided, and (d) sharing the information provided with their own healthcare professionals (when appropriate)? | + | - **uptake** in terms of (a) installing the application, (b) giving consent to receiving the PGx passport, (c) 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. | + | |
| + | Sociodemographic characteristics, health status and use of medication, health literacy, perceived barriers, facilitators, and benefits of sharing the PGx passport were taken into account as potential determinants. | ||
| ===== Protocol ===== | ===== 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. | + | The pGxP study ran between April and July 2024.\\ |
| - | + | * First, n=~4300 selected participants received an invitation to fill in a baseline PGxP questionnaire abou their health, medication use, digital skills, attitude toward DNA research and PGx passports. Participants were informed that if they filled in the questionnaire, they would be offered access to their personal PGxP via a smartphone app (if they were interested).\\ | |
| - | ===== Subcohort ===== | + | * Of the n=~1150 respondents to the baseline PGxP questionnaire, n=~1000 participants also gave permission to upload their personal pharmacogenetic characteristics into the 'Gen en Geneesmiddel' app that they could then install and access on their smartohone.\\ |
| - | + | * A total of n=~620 participants completed all the steps and received their personal information in the app.\\ | |
| - | Imalife ran from 2017 to 2022. The assessments were performed in ~12.000 Lifelines [[cohort|participants]] of 45+ years who completed a [[pulmonary function test]].\\ | + | * As a final step, all ~1150 respondents to the baseline PGxP questionnaire received a follow-up questionnaire containing questions on their decision-making process, opinion on the shared information and on the app, and the actual use of the PGxP (if applicable). |
| - | 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 ===== | + | |
| - | + | ||
| - | * Xia, C et al. (2019) [[https://journals.lww.com/thoracicimaging/fulltext/2021/05000/cardiovascular_risk_factors_and_coronary.6.aspx|Cardiovascular Risk Factors and Coronary Calcification in a Middle-aged Dutch Population]]. Journal of Thoracic Imaging 36(3): 174-180 | + | |
| - | * Van den Oever L.B. et al. (2020) [[https://linkinghub.elsevier.com/retrieve/pii/S0720-048X(20)30303-X|Deep learning for automated exclusion of cardiac CT examinations negative for coronary artery calcium]]. European Journal of Radiology 129, 109114 | + | |
| - | * Xia, C et al. (2021) [[https://linkinghub.elsevier.com/retrieve/pii/S1934-5925(20)30145-3|High-pitch dual-source CT for coronary artery calcium scoring: A head-to-head comparison of non-triggered chest versus triggered cardiac acquisition]]. Journal of Cardiovascular Computed Tomography 15(1): 65-72 | + | |
| - | * Lancaster, H et al. (2021) [[https://www.nature.com/articles/s41598-021-88328-y|Seasonal prevalence and characteristics of low-dose CT detected lung nodules in a general Dutch population]]. Sci Rep 11(1): 9139 | + | |
| - | * Dudurych, I. et al. (2021) [[https://eurradiolexp.springeropen.com/articles/10.1186/s41747-021-00247-9|Creating a training set for artificial intelligence from initial segmentations of airways]] Eur Rad Exp 5, 54 | + | |
| - | * Cai, J. et al. (2022) [[https://www.sciencedirect.com/science/article/pii/S0720048X22002601?via%3Dihub|CT characteristics of solid pulmonary nodules of never smokers versus smokers: A population-based study]]. Eur J Radiol 154:110410 | + | |
| - | * Wisselink, H. et al. (2023) [[https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0287383|Predicted versus CT-derived total lung volume in a general population: The ImaLife study]]. Plos ONE 18(6):e0287383 | + | |
| - | * Dudurych, I. et al. (2023) [[https://link.springer.com/article/10.1007/s00330-023-09615-y|Reproducibility of a combined artificial intelligence and optimal-surface graph-cut method to automate bronchial parameter extraction]]. Eur Radiol 33, 6718–6725 | + | |
| - | * Wisselink, H et al (2023) [[https://www.sciencedirect.com/science/article/pii/S0720048X23000232?via%3Dihub|CT-based emphysema characterization per lobe: A proof of concept]] Eur J Rad 160, 110709 | + | |
| - | * Cai, J et al. (2024) [[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11154756/|Who is at risk of lung nodules on low-dose CT in a Western country? A population-based approach]] ERJ Open 63(6): 2301736 | + | |
| - | * Sourlos, N. et al. (2024) [[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11102890/|Effect of emphysema on AI software and human reader performance in lung nodule detection from low-dose chest CT]] Eur Radiol Exp 8(1):63 | + | |
| - | * Dudurych I et al. (2024) [[https://pubs.rsna.org/doi/epdf/10.1148/radiol.232677|Low-dose CT–derived bronchial parameters in individuals with healthy lungs]] Radiology 311(3):e23267 | + | |
| ===== Variables ===== | ===== Variables ===== | ||
| - | A precise list of variables derived from CT-scans will be described later. | + | A precise list of variables in the PGxP questionnaires will be provided later. |
pgxp.1730716470.txt.gz · Last modified: 2025/02/05 14:49 (external edit)
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