The long term survival rates and treatment side-effect profiles of most prostate cancer patients combine to emphasize the importance of serial monitoring of health-related quality of life (HRQOL) in advancing clinical care and treatment outcome research. With the advent of prostate specific antigen (PSA) testing, prostate cancer detection rates continue to increase resulting in more and younger men having to cope with the impact of treatment on HRQOL. Specific HRQOL areas of concern for this population of men include sexual, urinary, and bowel dysfunction [1, 2]. These side-effects are also known to change over time and can have considerable impact on the patient's emotional, functional, and social well-being [2–4].
Frequent and systematic collection of HRQOL information in the prostate cancer patient population is therefore necessary for informed treatment decision-making, thorough patient care, and comprehensive evaluation of treatment outcome. In collecting this ongoing data, traditional paper questionnaires can be problematic within the clinic setting. For example, if clinical decision-making necessitates input from patient questionnaire data, the paper format can require too much processing time to be helpful under the usual time constraints of the clinical consultation . Furthermore, whether the questionnaire data are electronically scanned or manually entered into a clinic database for analysis, the integrity of the data is vulnerable to data entry errors . These limitations to the traditional paper questionnaire data capture method may be overcome with the use of an electronic data collection system.
Electronic data capture with desktop computers (including touch-screen applications) [7, 8], tablets , or hand-held personal digital assistants (PDA) [6, 10, 11] has been shown to improve data quality and allow for immediate and effective data manipulation. Electronic data collection improves data quality by providing software safeguards against entry omission and inconsistent response sets, and by completely eliminating data entry errors at the researcher's level. Moreover, because the data are captured electronically, data manipulation and analysis can be achieved faster than is possible with a paper data capture format. Indeed, results can be immediately scored, displayed and printed, allowing the clinician to review and interpret a patient profile in the company of the patient and discuss possible treatment decisions [6, 10, 11].
Although there may be a relatively significant start-up cost associated with electronic data collection, costs associated with questionnaires (paper and reproduction), data entry, coding, and cleaning are either eliminated or substantially reduced . Additionally, advances in technology continue to result in reduced costs associated with electronic data collection computer devices and software [10, 12].
Handheld PDA devices may be particularly economical and effective for electronic data collection in high traffic clinical healthcare settings [13–16]. PDA technology meets or exceeds the hardware requirements necessary for data collection in most clinical healthcare research. Given the low individual unit cost, multiple PDA units can be deployed at a fraction of the cost of a single desktop, laptop or tablet. The portability of the PDA offers greater flexibility within a clinic setting, less demand for clinic space (e.g. workstation) and, due to PDA energy efficiency, reduced dependence on battery power compared to laptops or tablets.
Moreover, for security purposes, PDA software allows for only a single patient's data to be collected at any one time. The data collected are protected through the use of multiple levels of encryption and a password access system. Once the PDA has been synchronized with the personal computer (PC), the patient self-reported data are purged from the unit. These features ensure that only the current user's data are stored on the PDA and that the data are only accessible to appropriate clinic staff. All other medical data are stored in the Prostate Centre main database and are not directly accessible on either the PC or PDA. The Prostate Centre database is safeguarded through industry standard security and operational protections. Therefore, if a PDA device is lost or stolen, sensitive information will not be accessible.
These advantages notwithstanding, there are some drawbacks to PDA data collection. A potential problem with electronic data collection devices, including the PDA, is that lack of computer literacy may cause some patients to prefer paper forms to computerized versions . The majority of studies, however, document patient acceptance of and preference for using PDAs over paper forms [12, 14, 17, 18]. Patients have also reported difficulty in seeing the questions due to the relatively small display screens in PDA [7, 19]. Increasing text font size and restricting the amount of text per screen can overcome this limitation. As well, some patients may be unfamiliar with using PDA devices and may require guidance/training from clinic staff.
Before PDA data collection techniques can be justifiably used for clinical or research purposes in healthcare clinics, this mode of data collection needs to be adequately validated for use with specific measures and patient populations. The aim of this project is to compare self-administered HRQOL measures in a PDA version with a paper version. Evaluation includes an assessment of data quality (internal consistency, test-retest reliability, response correlation, completeness of data), and feasibility (participation rates, time to completion, preference, and difficultly/ease of using PDA). The unique relevance of this research is its focus on 1) the responses of prostate cancer patients to the PDA data collection system, and 2) the adaptability of the International Prostate Symptom Score (IPSS), the Patient Oriented Prostate Cancer Utility Survey (PORPUS), and the International Index of Erectile Function-5 (IIEF-5) to the PDA format.