By Will Boggs MD
NEW YORK (Reuters Health) - An intervention for patients with chronic obstructive pulmonary disease (COPD) that combines transitional care and long-term self-management support is associated with more hospitalizations and emergency department visits, compared with usual care, researchers report in JAMA.
That's not what the researchers originally reported. In November 2018, due to a programming error that coded intervention patients as usual care patients and vice versa, the researchers reported the opposite findings (i.e., beneficial outcomes associated with the intervention). They retracted that publication today and replaced it with the current corrected paper.
Outpatient studies of COPD self-management support have shown improvements in health-related quality of life (HRQOL) and reductions in COPD-related acute care events. Similar studies among hospitalized patients with COPD have been lacking.
Dr. Hanan Aboumatar from Johns Hopkins School of Medicine, Baltimore, Maryland and colleagues tested the 3-month BREATHE Program - including transition support, individualized COPD self-management support, and facilitated access to community programs and treatment services - in 240 patients hospitalized for COPD.
As reported online today in JAMA, the mean number of COPD-related acute care events (hospitalizations and ED visits) per patient during the 6 months after discharge, the primary study outcome, was significantly higher in the intervention group (1.40) than in the usual care group (0.72) (P=0.004).
At 6 months after discharge, there was no significant difference in HRQOL, as measured by the St. George's Respiratory Questionnaire, between the intervention and usual care groups.
There were 8 deaths (6.7%) in the intervention group and 7 deaths (5.8%) in the usual care group (P>0.99), and the 6-month event-free survival probability for no death or COPD-related acute care event was significantly lower in the intervention group (45%) than in the usual care group (58%) (P=0.02).
"Most surprising was that study participants with high activation levels at baseline, meaning those who are more active managers for their own health, had higher acute care use in the intervention group, compared to usual care group," Dr. Aboumatar told Reuters Health by email. "Prior research studies had demonstrated less acute care use amongst patients with various health conditions who have high activation levels."
"This unanticipated finding may reflect a unique challenge met by patients with COPD who are trying to self-manage breathing symptoms that by nature can be sufficiently alarming for them to seek acute care when medical attention is not otherwise readily accessible," she said. "The concerning nature of these symptoms may similarly affect medical providers who may be more likely to refer these patients to the emergency room or admit them to the hospital for further monitoring and treatment."
"More research is needed to determine the most effective ways to support patients who are living with COPD and minimize their need to use acute care services," Dr. Aboumatar concluded. "COPD is a highly prevalent condition worldwide with major burden on patients, families, and the society at large. Little funding has been devoted to research on COPD compared to other diseases."
Dr. Seppo T. Rinne from Boston University School of Medicine, Boston and Center for Healthcare Organization and Implementation Research, Veterans Affairs, Bedford, Massachusetts, who co-authored an editorial related to this report, told Reuters Health by email, "The entire narrative calls into question the singular focus on specific metrics that we use to define quality. It may not be appropriate to penalize hospitals for excess COPD readmissions when we do not know how to effectively reduce acute care events for patients with COPD, and the interventions that are designed to improve this outcome are having the opposite effect."
"We have limited evidence on how to effectively reduce COPD hospitalizations, but that may not be the best outcome," he said. "Perhaps we should focus interventions on the things that matter most to patients, or patient-centered outcomes. To the authors' credit, they included quality of life as a co-primary outcome, and there was no significant difference between intervention and control patients."
Dr. Rinne added, "I think we need to acknowledge the integrity of the researchers and the ability of the scientific process to address an error. Mistakes happen. The earnest approach that the authors and journal took to amend the erratum is exemplary."
"JAMA remains committed to ensuring an accurate scientific record," Dr. Howard Bauchner, Editor in Chief of JAMA, and Dr. Robert M. Golub, Deputy Editor, write in another related editorial. "In most cases, identification of major errors has come from the study authors, who have notified JAMA of these errors after they were discovered when reusing the same database."
"We urge authors to continue to report errors in their own work, so that along with editors, they can jointly decide whether a correction, retraction, retraction with replacement, or retraction with republication is required," they conclude.
SOURCE: http://bit.ly/2AQKOOy, http://bit.ly/2VnxnPJ, http://bit.ly/2Vv5ANd and http://bit.ly/2oZE4vh