Clinical diagnosis and management of respiratory distress in preterm neonates: effect of participation in a controlled trial.

The ability to generalize the results of a clinical trial depends on the ability to compare a population of patients with the population described in the trial, emphasizing the importance of objective diagnostic criteria in study design and clinical medicine. However, clinical decisions are often based on subjective interpretations of data. There is concern that bias that an experimental therapy is beneficial might lead to alterations in clinical diagnosis and management. To evaluate this concern, the authors reviewed a preexisting database comprising information obtained by trained personnel by chart review to investigate prospectively the frequency of the diagnosis of hyaline membrane disease and the use of mechanical ventilation before and during participation in a clinical trial of surfactant therapy during which such therapy was available exclusively through clinical trials. Major eligibility criteria for a randomized trial at the Medical University of South Carolina included mechanical ventilation and the diagnosis of hyaline membrane disease. Both the diagnosis of hyaline membrane disease and the use of mechanical ventilation increased between pre-surfactant and randomized trial periods (hyaline: 47.2% to 55.9%, P less than .05; ventilation: 55.6% to 66.3%, P less than .01). The possibility that enthusiasm for surfactant influenced clinical diagnosis and management of respiratory distress during this period cannot be dismissed.

RCT Entities:   Population Interventions Outcomes