Table 1 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.

Intervention:

• Customized version of MiniDoc

• Daily diary

• Visual Analogue Scale (VAS)

Control:

• Paper diary

• Visual Analogue Scale (VAS)

Effectiveness of the electronic diary

Acceptability to patients

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

Intervention:

• Palm Pilot IIIxe

• Visual Analogue Scale (VAS)

Control:

• Paper Visual Analogue Scale (VAS)

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

Intervention:

• 3Com Palm IIIx

• Data entry into an Excel spreadsheet

Control:

• Paper duplicate of Excel spreadsheet.

Speed/Time

Accuracy as measured by error incidence

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

Intervention:

• Mini Doc, a portable electronic data capturing device.

Control:

• Paper and pencil survey form

Accuracy

Acceptibility to patients

Internal consistency reliability

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

Intervention:

• Apple Newton Message Pad

• visual analogue scale questionnaire

Control:

• Paper and pencil

• visual analogue scale questionnaire

Comparability of methods (Equivalence)

Patient preferences

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

Intervention:

• Apple Message Pad

• Daily diary

Control:

• Paper and pencil

• Daily diary

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

Intervention:

• Apple Message Pad.

• Daily diary

Patient preferences

Ease of use

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

Intervention:

• Apple Newton Message Pad.

• Quality of Life questionnaire (QOL)

Control:

• Paper and pencil

Comparability of methods, looking at missing and problematic data

Patient preferences

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

Intervention:

• "Food-Meter" (Miles, Elkhart, IN)

• Daily diary

Control:

• Paper and pencil

• Daily diary

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

Intervention:

• Palm III with bar code reader

Control:

• Touch-sensitive paper diary.

Compliance Timeliness Accuracy Preference