Subgroup Analysis in Pulmonary Hypertension-Specific Therapy Clinical Trials: A Systematic Review
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...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-05-01
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| Series: | Journal of Personalized Medicine |
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| Online Access: | https://www.mdpi.com/2075-4426/12/6/863 |
| _version_ | 1797485567048417280 |
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| author | Héctor Rodríguez-Ramallo Nerea Báez-Gutiérrez Remedios Otero-Candelera Laila Abdel-kader Martín |
| author_facet | Héctor Rodríguez-Ramallo Nerea Báez-Gutiérrez Remedios Otero-Candelera Laila Abdel-kader Martín |
| author_sort | Héctor Rodríguez-Ramallo |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-09T23:21:33Z |
| format | Article |
| id | doaj.art-8da3044452244dd4933db41ee2a2ede1 |
| institution | Directory Open Access Journal |
| issn | 2075-4426 |
| language | English |
| last_indexed | 2024-03-09T23:21:33Z |
| publishDate | 2022-05-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Journal of Personalized Medicine |
| spelling | doaj.art-8da3044452244dd4933db41ee2a2ede12023-11-23T17:26:42ZengMDPI AGJournal of Personalized Medicine2075-44262022-05-0112686310.3390/jpm12060863Subgroup Analysis in Pulmonary Hypertension-Specific Therapy Clinical Trials: A Systematic ReviewHéctor Rodríguez-Ramallo0Nerea Báez-Gutiérrez1Remedios Otero-Candelera2Laila Abdel-kader Martín3Hospital Pharmacy Department, Virgen del Rocio University Hospital, 41004 Seville, SpainHospital Pharmacy Department, Reina Sofía University Hospital, 14004 Cordoba, SpainPneumology Department, Virgen del Rocio University Hospital, 41004 Seville, SpainHospital Pharmacy Department, Virgen del Rocio University Hospital, 41004 Seville, SpainPulmonary 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.https://www.mdpi.com/2075-4426/12/6/863pulmonary hypertensionsubgroup analysesrandomized controlled trialsmethodological limitations |
| spellingShingle | Héctor Rodríguez-Ramallo Nerea Báez-Gutiérrez Remedios Otero-Candelera Laila Abdel-kader Martín Subgroup Analysis in Pulmonary Hypertension-Specific Therapy Clinical Trials: A Systematic Review Journal of Personalized Medicine pulmonary hypertension subgroup analyses randomized controlled trials methodological limitations |
| title | Subgroup Analysis in Pulmonary Hypertension-Specific Therapy Clinical Trials: A Systematic Review |
| title_full | Subgroup Analysis in Pulmonary Hypertension-Specific Therapy Clinical Trials: A Systematic Review |
| title_fullStr | Subgroup Analysis in Pulmonary Hypertension-Specific Therapy Clinical Trials: A Systematic Review |
| title_full_unstemmed | Subgroup Analysis in Pulmonary Hypertension-Specific Therapy Clinical Trials: A Systematic Review |
| title_short | Subgroup Analysis in Pulmonary Hypertension-Specific Therapy Clinical Trials: A Systematic Review |
| title_sort | subgroup analysis in pulmonary hypertension specific therapy clinical trials a systematic review |
| topic | pulmonary hypertension subgroup analyses randomized controlled trials methodological limitations |
| url | https://www.mdpi.com/2075-4426/12/6/863 |
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