Table 1

Summary of randomized controlled trials comparing handheld computers to paper and pen.

Study

Purpose

Design

Duration of Follow Up

Location

Patient Population

Number of Subjects

Instrument and Mode of Entry

Outcome Measures


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


Lane et al. BMC Medical Informatics and Decision Making 2006 6:23   doi:10.1186/1472-6947-6-23

Open Data