CHICAGO—Written action plans for patients with asthma are frequently used as part of self-management programs, but do they work? It’s impossible to say, concluded a systematic review of available literature.[1] Current studies of written action plans are either flawed or inconclusive.

Researchers sought to determine whether the addition of a written action plan to self-management programs improves asthma outcomes, and to compare the effect of a symptom-based written action plan with a plan based on peak flow monitoring. Using several databases, the investigators performed a literature search of studies published between 1980 and August 2000.

STUDY FLAWS ABOUND

Initially, the researchers identified 36 studies. After implementing quality indicators to weed out investigations with faulty designs, they were left with nine randomized controlled trials with a total of 1,501 patients. However, even these were disappointing—none met the researchers’ definition of high quality. Many studies lacked blinding, had no concealment of allocation, and/or excluded more than 10% of patients.

Five studies compared medical management plus a written action plan to medical management alone. There was no difference in outcomes between groups in four of these studies. The one study that demonstrated a 90% decrease in emergency department visits in the action plan group had several flaws that affected confidence in the validity of its results. For example, it did not include baseline comparisons or use baseline values as covariates. Additionally, baseline utilization data were derived from unverified patient recall.

Two studies assessed the independent effect of a written action plan used in conjunction with a peak flow meter. One reported no significant difference. The other, which showed large and favorable differences in the action plan group, was found to be biased on several counts: The participating physician was not blinded and was highly involved in patients’ assessment, monitoring, and treatment. In addition, 25% of patients were withdrawn from the study after randomization following an unexplained decline in lung function in the control group.

In the studies comparing a symptom-based action plan with a peak flow–based action plan, outcomes were generally the same between groups.

BETTER DESIGNS NEEDED

The Chicago researchers noted that few studies are designed for the type of systematic review they attempted. The population that was expected to benefit from the intervention was not identified in any of the studies, and the level of clinically meaningful outcomes was not defined.

The researchers also acknowledged that the studies did not disprove the effectiveness of written asthma plans per se. However, their results did imply that when such plans were applied to the general asthmatic population, the effect on outcomes would be small.

In the future, the researchers suggested, clinical trials should be selective and aimed at producing results that can improve self-management interventions. Specific populations, especially those with more severe illness, should be targeted because they are most likely to benefit from self-management programs such as a written action plan.

—Gale Jurasek