TY - JOUR T1 - E-patient reported outcomes: Can you have reliance on compliance? JF - European Respiratory Journal JO - Eur Respir J VL - 38 IS - Suppl 55 SP - p1208 AU - Aleck Harrison AU - Grant Sowman AU - Hardip KaurNagra AU - Richard Woodward Y1 - 2011/09/01 UR - http://erj.ersjournals.com/content/38/Suppl_55/p1208.abstract N2 - Introduction: Consistent evidence is required to confirm the value of electronic Patient Reported Outcomes (e-PROs) for compliance in Usage and Quality of PEF manoeuvres in large clinical trials where these data are used as critical end-points [1].Method: In an international asthma trial requiring twice daily symptom scores and three PEF manoeuvres over 105 days e-PROs were recorded using the Vitalograph PEF/FEV e-diary within a protocol specific program.Usage Compliance was assessed by the actual number of completed sessions made by patients as a percentage of the potential total. Quality Compliance assessed by Repeatability of the two highest manoeuvres of a session using the ATS/ERS standard of ≤40 L/min.Results: From 519 asthmatic patients at 78 sites a total of 103,198 diary sessions were made. Compliance during screening was 93±7%, treatment 88±13%.and overall 89±8%.Three manoeuvres were recorded in 99% of the sessions.Repeatability Compliance of PEF for both screen and treatment periods was 88%. The difference in PEF between the two highest manoeuvres was 13.85±10.3L/min.There was no statistical difference between the morning and evening data.Conclusion: These data concur with other previously published [2]. Thus e-PROs from asthmatic patients are consistent for both quantity and quality and have statistical reliance as the primary end-points for future trials.References:1. Johnston N. et al. The promise of electronic data capture in respiratory medicine. Eur Respir J 2011; 37: 2282. Harrison AJ et al. E-diary compliance in two pharmaceutical trials. Eur Respir J 2009; 34: E1854The sponsors of this trial are thanked for the anonymous use of their data. ER -