RT Journal Article
T1 Subgroup Analysis in Pulmonary Hypertension-Specific Therapy Clinical Trials: A Systematic Review.
A1 Rodríguez-Ramallo, Héctor
A1 Báez-Gutiérrez, Nerea
A1 Otero-Candelera, Remedios
A1 Martín, Laila Abdel-Kader
K1 methodological limitations
K1 pulmonary hypertension
K1 randomized controlled trials
K1 subgroup analyses
AB Pulmonary hypertension (PH) treatment decisions are driven by the results of randomized controlled trials (RCTs). Subgroup analyses are often performed to assess whether the intervention effect will change due to the patient's characteristics, thus allowing for individualized decisions. This review aimed to evaluate the appropriateness and interpretation of subgroup analyses performed in PH-specific therapy RCTs published between 2000 and 2020. Claims of subgroup effects were evaluated with prespecified criteria. Overall, 30 RCTs were included. Subgroup analyses presented: a high number of subgroup analyses reported, lack of prespecification, and lack of interaction tests. The trial protocol was not available for most RCTs; significant differences were found in those articles that published the protocol. Authors reported 13 claims of subgroup effect, with 12 claims meeting four or fewer of Sun's criteria. Even when most RCTs were generally at low risk of bias and were published in high-impact journals, the credibility and general quality of subgroup analyses and subgroup claims were low due to methodological flaws. Clinicians should be skeptical of claims of subgroup effects and interpret subgroup analyses with caution, as due to their poor quality, these analyses may not serve as guidance for personalized care.
SN 2075-4426
YR 2022
FD 2022-05-25
LK http://hdl.handle.net/10668/21381
UL http://hdl.handle.net/10668/21381
LA en
DS RISalud
RD Apr 18, 2025