Oops: Re-Analysis Flips Verdict on COPD Intervention

Allergies & Asthma

Re-analysis of a study initially published late last year unexpectedly showed evidence of harm associated with a program delivering intensive transitional care and self-management support to hospitalized patients with chronic obstructive pulmonary disease (COPD).

Initial findings from the single-center study, first published in JAMA last November, showed fewer hospitalizations and improvements in quality-of-life scores among COPD patients participating in the intensive, 3-month program conducted at Johns Hopkins Bayview Medical Center in Baltimore.

The researchers’ discovery of significant coding errors in their data analysis led to a rare retraction and republication of the findings, which appeared Tuesday in JAMA.

Instead of improving patient outcomes, the corrected analysis showed greater COPD-related hospitalizations and emergency department visits, with no improvement in patient quality-of-life, associated with the 3-month COPD self-management intervention.

Post-hoc analysis of the newly analysed data suggested that patients participating in the program were more aware of early signs of exacerbation and may have been more likely to seek medical care.

But the revised findings also raise questions about possible unintended consequences of highly intensive patient education and management programs like the one examined in the study, said pulmonologist Seppo T. Rinne, MD, PhD, of the Veterans Affairs Center for Healthcare Organization & Implementation Research in Boston.

Rinne was not involved with the research, but he co-authored editorials published with the initial study findings and the revised findings.

He told MedPage Today that the new findings have larger implications and highlight the limitations of policies targeting hospital readmission as a metric for treatment success.

“The study findings were published in JAMA because there have been few interventions that have been shown to reduce COPD hospitalizations and readmissions, and the [initial analysis] showed really dramatic reductions in both,” he said.

The revised analysis confirms that “there is still limited evidence on how to prevent COPD hospitalizations and readmissions,” Rinne added.

“We are left with a lack of guidance, from a healthcare system perspective, on how to define high-quality care for these patients,” he said. “The policies say we have to improve this metric, but we don’t know how to do that.”

As a result, Rinne said, health systems are implementing initiatives designed to reduce readmissions that are not evidence based. “These initiatives may not be helping patients, and some may even be harming them,” he said.

Study Details

The Johns Hopkins study, by Hanan Aboumatar, MD, MPH, and colleagues, included 240 patients hospitalized for COPD exacerbations, randomized in equal numbers to receive the intensive 3-month intervention or standard patient discharge care.

Key features of the intervention were hospital transition support, which included a post-discharge plan of care; individualized COPD-self-management support, which included instruction on recognizing exacerbation signs; and a follow-up action plan and facilitated access to community programs and treatment services.

The intervention was delivered by nurses with special training in the support of COPD patients.

A total of 203 patients completed the study, and the mean baseline score on health and well-being on the St. George’s Respiratory Questionnaire (SGRQ) was 62.3 among the intervention group and 63.6 among the usual-care group.

At the 6-month follow-up, the results were as follows:

  • The mean number of COPD-related acute care events among the intervention group was significantly higher than among the usual-care group (1.40; 95% CI 1.01-1.79 compared with 0.72; 95% CI 0.45-0.97: difference of 0.68, 95% CI 0.22-1.15; P=0.004)
  • There were 15 deaths (eight and seven in the intervention and usual-care groups, respectively) and 339 hospitalizations (202 in the intervention group and 137 in the usual-care group)
  • The mean change in SGRQ total score was 2.81 and -2.69 for the intervention and usual-care groups, respectively (difference 5.50, 95% CI -2.57 to 13.57; P=0.12)

The difference in scores was similar after adjustment for hospital unit and baseline SGRQ score (adjusted difference 5.18, 95% CI -2.15-12.51; P=0.11)

Differences in SGRQ scores had wide confidence intervals, “increasing uncertainty in estimating intervention effects on hospital-related quality of life,” the researchers wrote.

In the post-hoc analysis, the incidence rate ratio of COPD-related events at 6 months was 1.96 in the intervention group compared with the usual-care group (95% CI 1.57- 2.43; P<0.001) before adjustment and 1.59 (95% CI 1.32-1.92; P<0.001) after the researchers adjusted for age, home oxygen use, discharge unit, and hospitalization in the prior year.

“If the findings represent a true effect, the post-hoc subgroup analyses raise possible mechanisms, although these need to be considered speculative,” Aboumatar and colleagues wrote.

“The increase in acute care events was limited to patients with high activation status at baseline and was more common among men than women,” the team continued. “Patients with greater activation may have responded to the intervention by being more vigilant about detecting signs of early exacerbations and taking action to get medical attention within 24 hours, as recommended by their action plan. Inability to access their regular physician within that timeframe, due to various reasons, could have led them to seek acute care services.”

The researchers added that increased interaction with healthcare providers could have led to more emergency care referrals and hospitalizations.

“Further research is needed to determine reasons for this unanticipated finding,” the investigators concluded.

Funding for the research was provided by the Patient-Centered Outcomes Research Institute (PCORI), and the National Heart, Lung, and Blood Institute.

Aboumatar reported receiving grants from PCORI; a co-author reported financial relationships with AstraZeneca/Medimmune, Boehringer Ingelheim, GlaxoSmithKline, AbbVie, Contrafect, Kiniksa, Novartis, Pulmonx, Roche, Spiration, Sunovion, Syneos, Merck, Circassia, Pneuma, Verona, Bonti, Denali, Aradigm, Pearl Therapeutics, and Sanofi.


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