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The termination of a randomized clinical trial for poor Hispanic children
M A Lewis1, G Rachelefsky, C E Lewis
1School of Nursing, University of California-Los Angeles.
Insights
This study on pediatric asthma education for Hispanic children found that providing adequate medical care significantly reduced emergency room visits. Ethical considerations arose due to initial inadequate care for the control group.
Area of Science:
- Pediatric Pulmonology
- Clinical Trial Design
- Health Disparities
Background:
- Asthma management in children requires ongoing medical care and patient education.
- Disadvantaged families often face barriers to accessing and adhering to asthma treatment plans.
- Previous educational interventions for pediatric asthma have shown variable success.
Purpose of the Study:
- To evaluate the efficacy of a Spanish-language educational program as an adjunct to medical care for children with asthma.
- To assess the impact of improved care on emergency department utilization in pediatric asthma patients.
- To explore ethical considerations in clinical trials involving vulnerable populations.
Main Methods:
- A randomized clinical trial was designed.
- The study involved 138 Hispanic children (ages 7-12) from disadvantaged families with a history of emergency facility use.
- The trial was modified due to observed inadequate care, with all participants eventually receiving adequate care.
Main Results:
- The study revealed significant barriers to self-care and knowledge application among participants.
- Providing adequate medical and nursing care from research staff led to a significant reduction in emergency department and hospital use for all children.
- The randomized clinical trial design was altered due to ethical concerns regarding the control group's care.
Conclusions:
- Researchers must address potential ethical issues when conducting trials with low-income children.
- Ensuring adequate medical care is crucial for improving health outcomes in pediatric asthma patients.
- Interventions for pediatric asthma should consider socioeconomic factors and access to care.
Objective:
To conduct a randomized clinical trial of the Spanish version of an educational program designed to be an adjuvant to adequate medical care of children with asthma.
Design:
Randomized, clinical trial.
Setting:
Los Angeles County, Calif.
Participants:
One hundred thirty-eight Hispanic children, ages 7 to 12 years, from disadvantaged families. All had used emergency facilities of major local hospitals in the previous year. MEASUREMENT/MAIN RESULTS: As the study proceeded, it became apparent that subjects were receiving inadequate medical and nursing care and had numerous barriers to applying knowledge and self-care skills gained from the program. Realizing this, we considered it unethical to allow the control children to suffer for the duration of the trial (1 year). Therefore, all children received "adequate" care from the research staff, and the randomized clinical trial, as originally designed, was ended. The emergency department/hospital use by both groups was significantly reduced compared with previous experience.
Conclusion:
Those researchers conducting randomized trials involving poor children should be aware of the potential ethical problems inherent in such ventures.