| Literature DB >> 16737535 |
Shannon J Lane1, Nancy M Heddle, Emmy Arnold, Irwin Walker.
Abstract
BACKGROUND: Handheld computers are increasingly favoured over paper and pencil methods to capture data in clinical research.Entities:
Mesh:
Year: 2006 PMID: 16737535 PMCID: PMC1513201 DOI: 10.1186/1472-6947-6-23
Source DB: PubMed Journal: BMC Med Inform Decis Mak ISSN: 1472-6947 Impact factor: 2.796
Summary of randomized controlled trials comparing handheld computers to paper and pen.
| Quinn P et al. 2003 33 | To assess the effectiveness of a portable electronic diary as a data collection device for symptoms of an overactive bladder (OAB) | Randomized crossover study | 7 days/arm, 14 days total. | Patient's residence | Patients with a diagnosis of over-active bladder. | 35 patients were recruited, 2 were excluded post randomization. | Effectiveness of the electronic diary | |
| Jamison RN et al. 2002 34 | To compare the e-VAS (electronic) with p-VAS (paper) for cognitive and sensory stimuli. | Single centre randomized crossover study | Data collected in a 1 hour session | Institution | Healthy volunteers | 24 subjects | Validity and equivalence of methods | |
| Lal SO et al. 2000 35 | To determine whether electronic data collection and downloading to a personal computer spreadsheet is faster and more accurate than written data. | Randomized crossover design | Chart data collected within a 96 hour window period | Shriners Burns Hospital | Medical student volunteering for data collection | 3 medical students retrieving data from 110 medical charts | Speed/Time | |
| McBride JS et al. 1999 36 | To examine how data can be collected at point of care. Comparison of electronic and paper versions of a standard quality survey. | Randomized design | Data collected in one session | Wake Forest PhysiciansOrthopedics Department Clinics | Patients visiting an orthopedic clinic | 349 patients | Accuracy | |
| Stratton RJ et al. 1998 37 | To assess an electronic visual analogue scale with a paper method for appetite rating To examine test-retest reliability. | Randomized crossover study design | 4 day study Test-retest over 2 additional days | Subject's residence | Healthy free-living volunteers | 12 volunteers participated in comparison study, 13 participated in preference study | Comparability of methods (Equivalence) | |
| Tiplady B et al. 1997 (study 1) 38 | To assess the suitability of PDAs compared to paper diaries, for daily collection of data on lung function. | Randomized two period crossover design | 1 month/arm | Patient's residence | Out-patients with chronic obstructive airways disease | 22 patients | Comparability of methods, re: data quality (missing and problematic data) | |
| Tiplady B et al. 1997 (study 2) 38 | To assess the suitability of electronic diary for home use, transmitting respirology data. | Observational study | Completed electronic diary for 1 month | Patient's residence | Patients with chronic airways disease. | 37 patients | Patient preferences | |
| Drummond HE et al. 1995 39 | To compare the responses obtained from a quality of life (QOL) questionnaires using electronic (PDA) and conventional (paper). | Randomized, open, two period crossover | 3 office visits; 1 for training, 1 to complete each arm. | Institution | Patients attending a gastrointestinal clinic as outpatients | 46 patients | Comparability of methods, looking at missing and problematic data | |
| Rivellesse AA et al. 1991 40 | To evaluate an electronic (Food-Meter) method for recording 7-day food intake. | Randomized cross-over design repeated once. | 4 weeks | • patient's residence | Insulin-dependent diabetic patients (IDDM) | 21 | Agreement between methods | |
| Walker I et al. 2004 32 | To compare handheld computers and paper diaries for recording intravenous infusions of hemophilic clotting factor concentrates. | Randomized controlled trial, parallel design. | 6 months | • patients' residence | Patients with hemophilia | 41 | Compliance Timeliness Accuracy Preference |
Summary of the results of data accuracy assessed in six randomized controlled trials
| Tiplady B et al. 1997 38 | Missing data 8.91% | Missing data 0.16% | Accuracy was defined by comparing missing and problematic data between the two methods. |
| McBride JS et al. 1999 36 | No difference in missing item responses between PDA and paper in 4/5* subscales, (p < 0.05). | No differences in missing item responses between PDA and paper in 4/5* subscales, (p < 0.05). | Defined as a comparison of missing item responses between the two methods. |
| Lal SO et al. 2000 35 | 2.8% error frequency. | 6.7% error frequency | Data fields analyzed for frequency of error were gender, race, date of birth, date of burn, date of admittance to hospital, and burn type. Accuracy determined by comparing these fields with original medical record. |
| Jamison RN et al. 2002 34 | Of 503 paired verbal stimuli in 24 subjects the correlation between paper and PDA ratings was r = .97 (range 0.95–0.98), for sensory stimuli r = 0.86 (range 0.81–0.92). Correlation between group electronic VAS and paper VAS ratings to common verbal stimuli r 2 = 0.997, for the common sensory stimuli group correlation was r 2 = 0.99. | Defined as the degree of correlation between the two methods of rating. | |
| Quinn P et al. 2003 33 | Errors not possible in electronic diaries due to prompt and format of questions and responses. | Errors "detected" in 80% of paper diaries | Errors defined as incomplete times, inconsistent timing of events, incomplete events, incorrect completion of VAS. |
| Walker I et al. 2004 32 | 3 vials/patient not accounted for. | 5 vials/patient not accounted for (P = 0.45). | Both the number of vials/patient not accounted for in each group and the number of patients in each group with errors. |
*The subscale in which differences in missing item responses were found was the 1st response choice on PDA, authors suggest this could be attributed to learning effect.
Summary of the findings related to timelines in the four studies reporting this outcome.
| Rivellese AA et al.1991 40 | 1 minutes/week to transfer data into computer with 'Food-Meter' cable hook up. | > 30 minutes/week with conventional method. Specific data not provided. | No conclusions were made |
| Tiplady B et al.1997 38 | Authors claim electronic diary automation reduced total data handling time by over 80%; specific data not provided. | Specific data not provided | No conclusions were made |
| Lal SO et al. 2000 35 | Average PDA data collection and hook up time was 50 minutes for every group of 10 patients entered | Manual collection with computer entry method was 65 minutes for each group of 10 patients. Total time decreased by 23% | Handheld computers decreased total time by 23% |
| Walker I et al. 2004 32 | 0.25 days from intravenous infusion to receipt of data. | 25 days from intravenous infusion to receipt of data. | Major statistical and clinical significance. |
Summary of RCTs assessing patient preference
| Drummond HE et al., 1995 39 | 26/46 (57) | 6/46 (13) | 14/46 (30) |
| Tiplady B et al., 1997 38 | 13/22 (59) | 4/22 (18) | 5/22 (23) |
| Stratton RJ et al., 1998 37 | 5/13 (38) | 7/13 (54) | 1/13 (8) |
| Walker I et al.,2004 | 10/10 (100) | 0/10 (0) | 0/10 (0) |