| Popis: |
Background. Pulmonary hypertension (PH) treatment decisions are driven by randomized controlled trials (RCTs) results. Subgroup analyses are often performed to assess whether the intervention effect will change due to the patient’s characteristics. As subgroup claims may mislead clinician treatment decisions, there is a need for standards of such analyses.Objective. To evaluate the appropriateness and interpretation of subgroup analysis performed in pulmonary hypertension-specific therapy RCTs.Methods. A systematic review of the literature for pulmonary hypertension-specific therapy RCTs published between January 2000 and December 2020 was conducted. Claims of subgroup effects were evaluated with Sun X et al., 2012 criteria.Results. 30 RCTs were included. Evaluated subgroup analyses presented: a high number of subgroup analyses reported, lack of prespecification, and interaction test. The trial protocol was not available for most RCTs; significant differences were found in those articles which published the protocol. Authors reported 13 claims of subgroup effect, with 12 claims meeting 4 or fewer Sun criteria. Conclusion. Subgroup analyses in pulmonary hypertension-specific therapies are of poor quality. The lack of published protocols limited our capability to assess whether the published results correspond to the initially predefined analyses. Most claims of subgroup effect did not meet critical criteria. |
