Journal Retracts, Republishes COPD Study After Authors Find Intervention Created Harm, Not Benefit

JAMA on Tuesday retracted and republished a 2018 study about chronic obstructive pulmonary disease (COPD) after the discovery of a programming error in the statistical analysis. The subsequent complete reanalysis by the authors showed that the intervention that was studied showed harm, rather than benefit, to patients.¹

In addition to publishing a new version of the article, JAMA published an editorial² and an editor’s note³ and praised the authors for coming forward with the new information, which showed that a 3-month program combining transitional care and long-term self-management support on the outcomes of patients hospitalized with COPD led to increased hospitalizations and emergency department visits, rather than fewer.

“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 the error,” said the editorial. In addition, the authors said the findings are still important, noting that the question remains regarding why care management strategies for people with COPD often fall short of the goal of improving outcomes.

The study, led by authors from Johns Hopkins, evaluated 240 patients in a randomized clinical trial, with half assigned to an intervention group. Those patients received a comprehensive 3-month program to assist them in their caregivers with long-term self-management of COPD; the program was delivered by specially trained nurses. The usual care group included transition support for 30 days after discharge.

The reanalysis demonstrated that the intervention substantially increased the risk of COPD-related acute care events. The mean number of COPD-related hospitalizations and emergency department visits per participant at 6 months was 1.40 (95% CI, 1.01-1.79) in the intervention group versus 0.72 (95% CI, 0.46-0.97) in the usual care group (difference, 0.68; 95% CI, 0.22-1.15; P = .004).

The revised findings are consistent with other studies showing that efforts to prevent COPD hospitalizations have demonstrated mixed results, with more recent trials also reporting negative effects.

In a post hoc analysis, the authors found that the increased risk of hospitalizations and ED visits were centered on patients who are actively involved in their care; it’s possible that these patients either delayed seeking care when they needed it, or conversely became more attuned to their respiratory symptoms and also sought care.

The editorial also suggested that frequent contact with nurses and increased attention on their disease may have spurred anxiety, which led to unnecessary care.

In a letter to the editor⁴, the lead author and a coauthor described the programming errors and other errors that created the original, incorrect results. As a result, they said the Johns Hopkins Biostatistics Center created a new standard operating procedure, including a verification process at the beginning and end of each trial analysis.

“The accuracy of the scientific record is one of the most important priorities for authors and editors,” wrote Howard Boucher, MD and Robert M Golomb, MD, the editor-in-chief and deputy editor, respectively, in an editor’s note.

References

1. Aboumatar H, Naqibuddin M, Chung S, et al. 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: A randomized clinical trial. JAMA. 2019;322(14):1371-1380. doi:10.1001/jama.2019.11982.

2. Rinne ST, Lindenauer PK, Au DH. Unexpected harm from an intensive copd intervention. JAMA. 2019;322(14):1357-1359. doi:10.1001/jama.2019.12976.

3. Bauchner H, Golub RM. Ensuring an accurate scientific record—retraction and republication. JAMA. 2019;322(14):1380. doi:10.1001/jama.2019.14503.

4. Notice of Retraction. Aboumatar et al. Effect of a program combining transitional care and long-term self-management support on outcomes of hospitalized patients with chronic obstructive pulmonary disease: A randomized clinical trial. JAMA. 2018;320(22):2335-2343.