Electronic data collection methods such as Interactive Voice Response Systems (IVRS) are becoming increasingly popular in clinical research [1]. IVRS allow clinical research participants to answer automated survey questions over the telephone, either by pressing the telephone keypad or by issuing a voice response, where the responses are validated and stored in a database for later retrieval and analysis.
Advantages of IVRS include: consistency of survey administration, real time or close to real time data collection and storage, automated reminder calls, and the ability to restrict the time window during which the IVRS survey is available to study participants [1]. However, IVRS requires training and surveys may initially take longer to complete than corresponding paper diaries. Furthermore, there may be an additional cost associated with creating and maintaining an IVRS.
Due to the increasing popularity of IVRS, it has become important to know how IVRS and conventional paper diaries compare with respect to concordance of the collected data and adherence to each data collection method. Lauristen and colleagues compared completion rates of paper, IVRS, and telephone, diaries in which subjects were asked to record symptoms of gastroesophageal reflux disease twice daily. They found that the completion rate for paper diaries was significantly higher than IVRS or the telephone diary [2]. However, there was a higher autocorrelation of consecutive entries in paper diaries, indicating possible backfilling, and as a result they concluded that although paper diaries seem to yield a higher adherence rate, electronic diaries may improve the quality of data gathered. On the other hand, Weiler et al. compared data collected using both paper and IVRS from 87 adults with allergic rhinitis and found that the data obtained by these two methods were indistinguishable from one another [3]. Lundy and Coons demonstrated the measurement equivalence of IVRS and paper forms of a widely used instrument -the EuroQol-5D- for measuring health outcomes [4]. Other studies have established equivalence for paper and electronic versions of instruments such as the Changes of Sexual Functioning Questionnaire (CSFQ) [5]; and self-report diaries in a population of drug-addicted and alcohol-dependent individuals [6]. A study of orthopedic clinic patients who completed the Short Musculoskelatal Function Assessment (SMFA) using both paper and IVRS found no significant differences in individual subject responses between the two methods [7]. However, the IVRS completion rate was significantly less than the paper completion rate.
After reviewing the available literature, Tennen et al proposed that paper diaries can be effective in situations where behaviors being studied are discrete, when same-day relationships are informative, if a lagged effect across days is expected, or if the end of day recall experience associated with paper diaries is desirable. On the other hand, electronic diaries are preferable when examining within-day temporal dynamics and when evaluating rapidly changing temporal phenomena. They also pointed out that the characteristics of the study population can influence the acceptability of electronic diaries, such as in older populations [8].
In this context, patients undergoing radiation therapy for head and neck cancer represent a unique population with significant morbidity associated not only with the underlying disease but also with the treatment (radiation therapy). There has been a large increase in clinical research in this population, addressed to treatment of the cancer and the side-effects of radiation therapy, notably mucositis [9–11]. In addition, routine clinical care of these patients also involves collection of data to monitor pain, side-effects, etc. It therefore becomes important to know how paper and electronic diaries, including IVRS, compare in this population so that future research studies and clinical data collection can be appropriately designed.