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The Termination of a Randomized Clinical Trial for Poor Hispanic Children

Mary Ann Lewis, DrPH, RN; Gary Rachelefsky, MD; Charles E. Lewis, MD, ScD; Barbara Leake, PhD; Warren Richards, MD
Arch Pediatr Adolesc Med. 1994;148(4):364-367. doi:10.1001/archpedi.1994.02170040030005.
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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.(Arch Pediatr Adolesc Med. 1994;148:364-367)


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