A comparison of electronic and paper diaries as collection method of patient reported outcome measures

Abstract

Summary

Introduction: The patient perspective in the form of patient reported outcome measures (PROMs) is increasingly been utilised as a legitimate outcome in clinical research. In certain medical conditions, notably chronic ones, the repeated measures of PROMS over time by way of health diaries can be appropriate. Traditionally PROM diary data has been collected using one or more validated paper questionnaires completed repeatedly. New technology, notably handheld computers being used as electronic diaries (EDs), has been heralded as a much improved collection method compared to the paper diaries. I wanted to assess the scientific evidence behind this claim by conducting a systematic literature review on studies comparing the ED and paper collection methods.

Aim: The aim of the dissertation was to systematically collect and evaluate the available scientific evidence on how EDs perform as collection tools of PROMs in clinical research compared to conventional pen and paper (P&P) diaries in terms of feasibility, protocol compliance, data accuracy and subject acceptability.

Method: A systematic review (SR) of randomised and quasi-randomised controlled health diary trials comparing the ED and P&P methods on patients with chronic health problems was conducted.

Results Nine studies were included in the review. Their methodological quality was variable, and the reporting standards poor. Due to heterogeneity issues with the data in the included studies, statistical analyses of the data were precluded. Instead a qualitative and descriptive analysis of the data material was conducted.

Five studies reported on feasibility and all five reported recurring technical difficulties with the EDs. Two studies reported that electronic collection leads to a substantial reduction in time used for data handling. Five studies reported that the ED method results in better protocol compliance, whereas one study demonstrated the opposite. All three articles reporting on data accuracy indicated that there are fewer errors in the ED data records compared to the paper records. Four articles scrutinised subject preference, and the ED method came out favourably in all four.

Conclusion: The ED collection method seems to perform better than P&P diaries in most of the selected outcomes. Technical malfunction is the chief disadvantage with the ED method resulting in loss of data. Further research comparing ED with paper data collection using more stringent methodology is needed.