A randomised crossover comparative study of e-diary (electronic diary) versus paper and pencil collection of quality of life data in patients with locally advanced and metastatic non small cell lung cancer
18536 Background: Electronic diaries have been developed and facilitate collection of quality of life data. However there is concern that their use may alter the properties of the validated quality of life questionnaires which have traditionally been collated using a paper and pencil methodology. This study aimed to compare the results of e-diary and paper and pencil collection of FACT-L and EQ-5D quality of life data, and to ascertain patient preferences for the different modes of collection. Methods: Fifty patients with previously treated locally advanced or metastatic NSCLC were randomised in a 1:1 ratio to either complete a paper version of the questionnaires (FACT-L and EQ-5D) followed by the e-diary (Palm Tungsten W;CRF inc. Helsinki), or e-diary followed by paper questionnaire. Patient preference, ease of use and time for completion were recorded on a separate paper questionnaire. Results: The majority (88%) of the FACT-L and all (100%) of the EQ-5D individual question responses were within ± 1 point by the two methods, although for FACT-L 29% of patients had a total score greater than ± 6 points different by the two methods. There was no significant difference in FACT-L group mean total score for the two methods. The mean completion time was shorter for the paper and pencil than the e-diary (p < 0.0001). However, most patients stated that they preferred the e-diary to paper and pencil (60% vs. 12%). Conclusions: This study suggests that the mode of administration of the FACT-L and EQ-5D had a relatively small effect on the group mean responses given to the questionnaires. However data at the individual patient level looks quite variable between mode of administration. The group results obtained using the e-diary should therefore be comparable to the originally validated paper method, with the advantages of improved patient acceptability and ease of reliable interfacing with trial databases. However care need to be taken in interpreting data at the individual level. No significant financial relationships to disclose.