Reply to Martelli et al. : eHealth in Cystic Fibrosis: Promising, but Proof of Concept Is Still Needed
Year: 2018
Type: letter
Abstract: We thank Dr. Martelli and colleagues for their interest in our study of home symptom and spirometric monitoring for individuals with cystic fibrosis (CF), termed the eICE (Early Intervention in Cystic Fibrosis Exacerbation) study (1).A study of this nature is complicated and poses many challenges that are not encountered in a typical drug trial.Blinding is certainly one aspect that we debated when designing our study, but as Dr. Martelli and colleagues noted, we did not believe it would be ethical to have patients perform home monitoring without study personnel acting on the results.Their letter raises concerns that certain study design factors may have biased the study toward a negative result.We agree with many of the issues raised in the letter, but they are primarily related to study conduct, which in many cases is beyond the control of investigators, rather than design.For example, the authors note that the population had relatively mild disease.The study entry criteria were much broader than those used in many CF trials and included patients with FEV 1 as low as 25% predicted.Also, as we note in our paper, the study population was very similar to the general CF population in the United States.Martelli and colleagues note that adherence with the study intervention was suboptimal.We concur, but supplemental analyses failed to demonstrate any differences in outcomes, whether or not individuals were adherent with the intervention.They also suggest that some alarms in the early-intervention arm may have been due to poor spirometry technique rather than pulmonary exacerbations.Although this is possible, patients with CF are generally very experienced in performing spirometry, and we have pilot data for individuals with CF that demonstrate good agreement between home spirometry and spirometry performed in a pulmonary function testing lab (2).We agree with Martelli and colleagues that differential loss to follow-up was problematic.More subjects in the early-intervention arm dropped out than in the usual-care arm.This may have been due to challenges with the technology we used for the study and the burden it placed on patients.Nevertheless, we performed several different sensitivity analyses and did not see differences in outcomes if we excluded subjects who withdrew early, or if we compared outcomes at the time subjects withdrew.Contrary to the author's viewpoint, we did not use the last observation carried forward approach for missing data.Rather, our primary analysis of the
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W2802522755