Huang CJ. 2008 Nov 12. Serial personal digital assistant data capture of health-related quality of life: a randomized controlled trial in a prostate cancer clinic. Mobile medical computing reviews. [Online]
Are data collected from PDA versions of paper health-related quality of life (HRQOL) measurement instruments reliable, valid and feasible? This paper focused on the following instruments: the International Prostate Symptom Score, the Patient Oriented Prostate Cancer Utility Survey, and the International Index of Erectile Function-5. PDA formats of the HRQOL questionnaires were preferred by the majority of patients enrolled in the study and they were completed more quickly compared to the paper format. The data quality was better because of greater data completion, while maintaining internal consistency, test-retest reliability, and response correlation. Compared to paper, handheld devices and formats appear to be a useful and valid modality for HRQOL questionnaires. However, there were unexplained domain-specific deviations in this study as well as an explicitly defined patient population.
Serial personal digital assistant data capture of health-related quality of life: a randomized controlled trial in a prostate cancer clinic
Matthew AG, Currie KL, Irvine J, Ritvo P, Santa Mina D, Jamnicky L, Nam R, Trachtenberg J. Health Qual Life Outcomes. 2007 Jul 6:5:38.
Reviewed by Craig J. Huang, MD
Research design/methodology
TYPE: randomized controlled trial
VALIDITY:
- There was no paper survey followed by paper survey group (a true control group).
- Potential bias as only patients who could read, speak, and write English; who did not have significant hearing or visual impairment; and were treated by an urologist co-investigator were included
- Statistical comparison of non-participants to participants regarding age of patients and reasons for attending the prostate cancer clinic were not significant
ENVIRONMENT: Prostate cancer clinic patients at a large urban hospital were approached in the clinic while registering at the reception area. A total of 216 patients were approached to participate in study: 31 patients refused; 16 patients failed to complete the entire study protocol; 17 patients whose clinic wait times were less than 30 minutes, thus not permitting the administration of the second questionnaire; and 152 patients included in the analysis.
Research question
What is the feasibility and quality of data collection from PDA versions of HRQOL instruments given to prostate cancer clinic patients?
Measured outcomes:
- Data quality: internal consistency, test-retest reliability, response correlation, and completeness of data
- Data feasibility: participation rates, time to completion, preference, and ease/difficulty of PDA use
Patient/Problem/Population definition
PATIENT USE: Health-related quality of life PDA data collection and capture system for prostate cancer clinic patients
PROBLEM: Traditional paper questionnaires are problematic for recording data regarding health-related quality of life information in prostate cancer clinic patients (e.g., poor access to electronic medical records).
POPULATION: Prostate cancer clinic patients
TYPE: clinical research
Intervention
PDAs as a tool for recording and collecting PDA-adapted versions of the following health-related quality of life measurement tools:
- International Prostate Symptom Score (IPSS): an 8-item measurement of patient voiding function
- Patient Oriented Prostate Cancer Utility Survey (PORPUS): a 10-item psychometrically validated survey specific for prostate cancer quality of life domains
- International Index of Erectile Function-5 (IIEF-5): shortened form of the International Index of Erectile Function that assesses aspects of erectile dysfunction
Technologies
The following technologies were described in this study:
- Palm Vx
- C++ programming for Palm Vx
- Visual Basic
- Microsoft Access
- Statistical Package for the Social Sciences (SPSS)
- Research Randomizer
Comparison
Prostate cancer clinic patients randomized to one of three HRQOL survey conditions:
- Paper survey followed by PDA survey (53 participants)
- PDA survey followed by paper survey (53 participants)
- PDA survey followed by PDA survey (46 participants)
Outcome
DATA QUALITY
- There was excellent internal consistency of data quality for both PDA and paper-based applications as measured by Cronbach's alpha.
- Intraclass correlation coefficients (ICCs) demonstrated statistically-significant test-retest reliability for PDA administration of the HRQOL instruments and strong correlations between their total scores and patients completing paper questionnaires (narrow confidence intervals for majority of ICCs).
- Overall, lower numbers of patients failed to complete at least one question for PDA versions of the questionnaires
Percentage of Respondents who Failed to Complete at Least One Question
| | IPSS | IIEF-5 | PORPUS |
| Condition 1 | | | |
| Paper 1st | 10.0 | 27.7 | 7.5 |
| PDA 2nd | 0 | 13.6 | 7.5 |
| Condition 2 | | | |
| Paper 2nd | 11.3 | 17.0 | 5.1 |
| PDA 1st | 0 | 6.8 | 5.7 |
| Condition 3 | 0 | 0 | 8.7 |
DATA FEASIBILITY
- No significant differences in level of participation for patients approached for study
- Mean times for survey completion were faster for PDA format (Conditions 1 and 2: 11.2 minutes and 8.6 minutes) vs. paper format (Conditions 1 and 2: 12.5 minutes and 10.2 minutes)
- 54.6% of patients preferred using the PDA format, 24.2% had no preference, and 17.2% preferred the paper format, with age and PDA use difficulty having no impact on preference
- 76% of patients were able to complete the PDA format without further instruction other than an initial one minute tutorial
Application of results to patient care
Handheld devices appear to provide reliable, valid, and feasible data from PDA versions of previously-validated paper HRQOL questionnaires when administered to prostate cancer clinic patients. The study patients may have been clinically diverse, but this was an explicitly defined patient population: a large urban hospital prostate cancer clinic with patients treated by a urologist co-investigator - the authors recognized this may limit the generalizability of the study's findings.
Further areas for research
What is the clinical impact of real-time patient-physician feedback on health-related quality of life information collected on PDA devices?
How do these PDA data capture techniques translate to other oncology patients or to those with a chronic, debilitating disease?
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