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Record W4415972259 · doi:10.1101/2025.11.04.25339466

Effects of polygenic risk score communication on health outcomes: systematic review and meta-analysis

2025· preprint· W4415972259 on OpenAlexaff
Luigi Russo, Nicolò Lentini, Sara Farina, Antonio Cristiano, Andrea Adduci, Alessio Perilli, Christian Cao, Roberta Pastorino, Stefania Boccia, John P. A. Ioannidis

Bibliographic record

VenuemedRxiv · 2025
Typepreprint
Language
FieldBiochemistry, Genetics and Molecular Biology
TopicBRCA gene mutations in cancer
Canadian institutionsUniversity of Toronto
FundersEuropean Commission
KeywordsMeta-analysisRandomized controlled trialPolygenic risk scoreDiseaseFramingham Risk ScoreSystematic reviewMEDLINERisk assessment

Abstract

fetched live from OpenAlex

Abstract Objective The purpose of this systematic review and meta-analysis is to summarize evidence from all RCTs to-date on the efficacy of polygenic risk score (PRS) communication in changing health outcomes. Design Systematic review and meta-analysis. Data sources Cochrane Central Register of Controlled Trials (CENTRAL) and Pubmed, from inception to March 2025. Study selection Randomized controlled trials comparing disclosure versus non-disclosure of PRS results. Intervention included comunication of risk information from ≥ 2 single nucleotide polymorphism (SNPs). Methods Pairs of reviewers conducted screening, extracted data and assessed risk of bias. Meta-analyses were conducted using inverse variance-weighting with fixed and random effects models. Otto-SR was used to verify screening and data extraction. Risk of bias was assessed with the Cochrane Risk of Bias 2 (RoB-2) tool. All measurable health-related outcomes were considered eligible. Results Of 7,830 articles retrieved, 27 RCTs were eligible. PRSs mainly predicted risks for cancer (n=9 RCTs), cardiovascular diseases (n=8), and diabetes (n=6). 21 RCTs targeted primarily healthy populations, 3 at-risk populations and 3 individuals who had already developed a disease and PRS predicted complications. 15/26 RCTs concluded in their abstracts with favorable claims about the PRS, with only 5/15 justifying it with any statistically significant results. 9/26 RCTs had high risk of bias. Meta-analysis revealed no statistically significant effects on any measured outcome, among 22 outcomes tested in 2 or more trials. Standardized mean differences (SMDs) (95% CI) for dietary outcomes were −0.11 (−0.23; 0.01) for daily energy intake, 0.08 (−0.15; 0.31) for daily fat intake and −0.11 (−0.28; 0.06) for alcohol consumption. For physical activity, SMD was −0.01 (−0.13; 0.11). Relative risks were 1.12 (0.77; 1.61) for screening attendance, 1.50 (0.98; 2.29) for statin use, and 0.95 (0.32; 2.79) for disease incidence. For psychological outcomes, SMDs were −0.02 (−0.13; 0.08) for anxiety, −0.06 (−0.23; 0.10) for worry, −0.10 (−0.40-0.19) for perceived risk, and −0.05 (−0.23; 0.13) for depression. For clinical outcomes, mean differences were −2.01 (−8.27; 4.26) for total cholesterol, −3.64 (−7.88; 0.60) for LDL cholesterol, −0.21 (−2.65; 2.23) for HDL cholesterol, −1.88 (−4.17;0.42) for diastolic blood pressure, −1.26 (−4.44; 1.92) for systolic blood pressure, −0.12 (−0.64; 0.39) for BMI and −0.33 (−0.87; 0.20) for weight. 69 outcomes had been reported in only a single trial (18/69 primary ones), and of those 2 had statistically significant results at p<0.05 as primary outcomes and 3 as secondary outcomes. Conclusions Overall, despite frequent promising claims, the disclosure of PRS typically did not lead to meaningful changes in behavioral, psychological or clinical outcomes. Systematic review registration OpenScience Framework: doi.org/10.17605/OSF.IO/28V6J Summary box Section 1: What is already known on this topic - Polygenic risk scores (PRSs) represents one of the most promising approaches of personalized medicine where communication of genetic information is expected to improve behavior and health outcomes. - Previous reviews have evaluated the communication of genetic risk but none have evaluated yet the effect of specifically PRS. - Since PRSs implementation in clinical practice is contemplated, rigorous evaluation of their impact is valuable for further implementation. Section 2: What this study adds - PRS communication effects were close to null for a large set of outcomes, demonstrating no improvement in preventive behaviours, including screening adherence or clinical measures. - High heterogeneity in RCTs in the field is present with small sample sizes, short follow-up periods, and many self-reported outcomes. - A gap is evident between the theoretical promise of PRS-guided prevention and its lack of documented real-world effectiveness.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.023
metaresearch head score (Gemma)0.058
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch
Consensus categoriesnone
DomainCandidate signal: Methods · Consensus signal: none
Study designCandidate signal: Meta-analysis · Consensus signal: Meta-analysis
GenreCandidate signal: Review · Consensus signal: Review
Teacher disagreement score0.977
Threshold uncertainty score0.123

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0230.058
Meta-epidemiology (narrow)0.0030.002
Meta-epidemiology (broad)0.0240.038
Bibliometrics0.0090.009
Science and technology studies0.0010.001
Scholarly communication0.0040.003
Open science0.0020.002
Research integrity0.0030.002
Insufficient payload (model declined to judge)0.0040.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.032
GPT teacher head0.340
Teacher spread0.307 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

Study designMeta-analysis
DomainMethods
GenreReview

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

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Citations0
Published2025
Admission routes1
Has abstractyes

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