A Novel Method to Combine Assessment of Benefit and Harm: Outcome Measures in Rheumatology 3×3 Methodology Applied to Two Active Comparator Trials

Maarten Boers, Jasvinder A. Singh, Stacey S. Cofield, S. Louis Bridges, Larry W. Moreland, James R. O'Dell, Hongsheng Wu, Sarah Leatherman, Jeffrey R. Curtis

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Objective: The Outcome Measures in Rheumatology (OMERACT) 3×3 method analyzes the occurrence of benefit and harm simultaneously at the individual patient level. We applied this method to 2 recent rheumatoid arthritis (RA) trial data sets. Methods: The Treatment of Early Aggressive Rheumatoid Arthritis (TEAR) and the Rheumatoid Arthritis Comparison of Active Therapies (RACAT) randomized trial outcomes for safety were defined according to OMERACT as having no adverse events (AEs), non-serious AEs, and serious AEs. Treatment efficacy was defined as good, moderate, or no response. A good treatment response without any AEs was labeled an unqualified success, and no treatment response but at least 1 AE was considered an unmitigated failure. The association between benefit and harm was assessed by chi-square or exact tests, as appropriate. Results: In TEAR, 612 of 755 patients had response data at 48 weeks: 14% of patients experienced unqualified success and 9% had unmitigated failure, with no difference between the treatment arms. Treatment response and AE rates were not correlated. In RACAT, 309 of 353 patients had response data at 48 weeks: 6% of patients experienced unqualified success and 11% had unmitigated failure, with no differences between the treatment arms. Response and AE rates were negatively correlated. The frequency of AEs and serious AEs increased as response decreased (P = 0.008). Conclusion: We found some evidence that clinical response may be reduced by the co-occurrence of AEs.
LanguageEnglish
JournalArthritis Care and Research
DOIs
StateE-pub ahead of print - 2019

Cite this

Boers, Maarten ; Singh, Jasvinder A. ; Cofield, Stacey S. ; Bridges, S. Louis ; Moreland, Larry W. ; O'Dell, James R. ; Wu, Hongsheng ; Leatherman, Sarah ; Curtis, Jeffrey R./ A Novel Method to Combine Assessment of Benefit and Harm: Outcome Measures in Rheumatology 3×3 Methodology Applied to Two Active Comparator Trials. In: Arthritis Care and Research. 2019
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title = "A Novel Method to Combine Assessment of Benefit and Harm: Outcome Measures in Rheumatology 3×3 Methodology Applied to Two Active Comparator Trials",
abstract = "Objective: The Outcome Measures in Rheumatology (OMERACT) 3×3 method analyzes the occurrence of benefit and harm simultaneously at the individual patient level. We applied this method to 2 recent rheumatoid arthritis (RA) trial data sets. Methods: The Treatment of Early Aggressive Rheumatoid Arthritis (TEAR) and the Rheumatoid Arthritis Comparison of Active Therapies (RACAT) randomized trial outcomes for safety were defined according to OMERACT as having no adverse events (AEs), non-serious AEs, and serious AEs. Treatment efficacy was defined as good, moderate, or no response. A good treatment response without any AEs was labeled an unqualified success, and no treatment response but at least 1 AE was considered an unmitigated failure. The association between benefit and harm was assessed by chi-square or exact tests, as appropriate. Results: In TEAR, 612 of 755 patients had response data at 48 weeks: 14{\%} of patients experienced unqualified success and 9{\%} had unmitigated failure, with no difference between the treatment arms. Treatment response and AE rates were not correlated. In RACAT, 309 of 353 patients had response data at 48 weeks: 6{\%} of patients experienced unqualified success and 11{\%} had unmitigated failure, with no differences between the treatment arms. Response and AE rates were negatively correlated. The frequency of AEs and serious AEs increased as response decreased (P = 0.008). Conclusion: We found some evidence that clinical response may be reduced by the co-occurrence of AEs.",
author = "Maarten Boers and Singh, {Jasvinder A.} and Cofield, {Stacey S.} and Bridges, {S. Louis} and Moreland, {Larry W.} and O'Dell, {James R.} and Hongsheng Wu and Sarah Leatherman and Curtis, {Jeffrey R.}",
year = "2019",
doi = "10.1002/acr.23590",
language = "English",
journal = "Arthritis Care & Research",
issn = "2151-464X",
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A Novel Method to Combine Assessment of Benefit and Harm: Outcome Measures in Rheumatology 3×3 Methodology Applied to Two Active Comparator Trials. / Boers, Maarten; Singh, Jasvinder A.; Cofield, Stacey S.; Bridges, S. Louis; Moreland, Larry W.; O'Dell, James R.; Wu, Hongsheng; Leatherman, Sarah; Curtis, Jeffrey R.

In: Arthritis Care and Research, 2019.

Research output: Contribution to journalArticleAcademicpeer-review

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T1 - A Novel Method to Combine Assessment of Benefit and Harm: Outcome Measures in Rheumatology 3×3 Methodology Applied to Two Active Comparator Trials

AU - Boers,Maarten

AU - Singh,Jasvinder A.

AU - Cofield,Stacey S.

AU - Bridges,S. Louis

AU - Moreland,Larry W.

AU - O'Dell,James R.

AU - Wu,Hongsheng

AU - Leatherman,Sarah

AU - Curtis,Jeffrey R.

PY - 2019

Y1 - 2019

N2 - Objective: The Outcome Measures in Rheumatology (OMERACT) 3×3 method analyzes the occurrence of benefit and harm simultaneously at the individual patient level. We applied this method to 2 recent rheumatoid arthritis (RA) trial data sets. Methods: The Treatment of Early Aggressive Rheumatoid Arthritis (TEAR) and the Rheumatoid Arthritis Comparison of Active Therapies (RACAT) randomized trial outcomes for safety were defined according to OMERACT as having no adverse events (AEs), non-serious AEs, and serious AEs. Treatment efficacy was defined as good, moderate, or no response. A good treatment response without any AEs was labeled an unqualified success, and no treatment response but at least 1 AE was considered an unmitigated failure. The association between benefit and harm was assessed by chi-square or exact tests, as appropriate. Results: In TEAR, 612 of 755 patients had response data at 48 weeks: 14% of patients experienced unqualified success and 9% had unmitigated failure, with no difference between the treatment arms. Treatment response and AE rates were not correlated. In RACAT, 309 of 353 patients had response data at 48 weeks: 6% of patients experienced unqualified success and 11% had unmitigated failure, with no differences between the treatment arms. Response and AE rates were negatively correlated. The frequency of AEs and serious AEs increased as response decreased (P = 0.008). Conclusion: We found some evidence that clinical response may be reduced by the co-occurrence of AEs.

AB - Objective: The Outcome Measures in Rheumatology (OMERACT) 3×3 method analyzes the occurrence of benefit and harm simultaneously at the individual patient level. We applied this method to 2 recent rheumatoid arthritis (RA) trial data sets. Methods: The Treatment of Early Aggressive Rheumatoid Arthritis (TEAR) and the Rheumatoid Arthritis Comparison of Active Therapies (RACAT) randomized trial outcomes for safety were defined according to OMERACT as having no adverse events (AEs), non-serious AEs, and serious AEs. Treatment efficacy was defined as good, moderate, or no response. A good treatment response without any AEs was labeled an unqualified success, and no treatment response but at least 1 AE was considered an unmitigated failure. The association between benefit and harm was assessed by chi-square or exact tests, as appropriate. Results: In TEAR, 612 of 755 patients had response data at 48 weeks: 14% of patients experienced unqualified success and 9% had unmitigated failure, with no difference between the treatment arms. Treatment response and AE rates were not correlated. In RACAT, 309 of 353 patients had response data at 48 weeks: 6% of patients experienced unqualified success and 11% had unmitigated failure, with no differences between the treatment arms. Response and AE rates were negatively correlated. The frequency of AEs and serious AEs increased as response decreased (P = 0.008). Conclusion: We found some evidence that clinical response may be reduced by the co-occurrence of AEs.

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