Work

Unexpected Harm From an Intensive COPD Intervention

Year: 2019
Type: article
Abstract: Science and sound clinical care both rely on honest reporting and, when necessary, self-correction.In this issue of JAMA, the Notice of Retraction 1 and republication of the article by Aboumatar et al titled, "Effect of a Hospital-Initiated Program Combining Transitional Care and Long-term Self-management Support on Outcomes of Patients Hospitalized With Chronic Obstructive Pulmonary Disease," 2 represent a commitment by the authors to ensure an accurate scientific record.Following discovery of an error in the analysis of data from the initial report, 3 the reanalysis by the authors now shows that the study's original conclusion changed remarkably from showing a strong benefit of the intervention to showing harm.The results of this study, as in all high-quality research, are important regardless of outcome.The authors have acknowledged and addressed the error in an open and transparent way.The integrity of science is built on the principle that scientists are forthright in their research, and these authors adopted an earnest approach to amend their error.The initial study by Aboumatar et al 3 was a randomized clinical trial of a 3-month intensive chronic obstructive pulmonary disease (COPD) intervention that combined transitional care support and chronic disease self-management.While results of the retracted publication suggested that patients in the intervention group had fewer COPD-related acute care events (hospitalizations and emergency department visits), the reanalysis demonstrated that the intervention substantially increased the risk of COPD-related acute care events. 2 The mean number of COPD-related acute care events (hospitalizations and emergency department visits) per participant at 6 months was 1.40 (95% CI, 1.01-1.79) in the intervention group vs 0.72 (95% CI, 0.46-0.97) in the usual care group (difference, 0.68 [95% CI, 0.22-1.15];P = .004). 2 Although there was no significant effect on health-related quality of life between the 2 groups, the direction of the results was consistent with the primary findings.The increased risk of harm associated with the study intervention was both unexpected and important.As the authors indicated, these results should be interpreted with caution, and additional research is needed to understand why this intervention was associated with increased acute events.At the same time, this work is consistent with other literature.Numerous clinical trials on strategies to prevent COPD hospitalizations have produced conflicting results, with all recent studies failing to demonstrate benefit and some reporting harm.4 The increased risk of acute care events found in the current study has parallels with the study by Fan et al 5 that found higher mortality among patients with
Source: JAMA
Language: English
Field: Medicine
Open Access status: bronze
Award: G971281072
OpenAlex ID: W2979640636
FWCI: 1.444
Cites: 13
Cited by: 10
Related to: 10