Dataset Information

Measurement Equivalence of "Touch-Screen" versus "Paper-Based" Assessments of OHRQoL: A Randomized Crossover Trial.

ABSTRACT: Purpose:To determine the measurement equivalence of computer touch screen assessment (CTSA) and paper based assessment (PBA) of the oral health impact profile (OHIP-14). Patients and Methods:A randomized crossover trial was conducted. Sixty participants were randomized to either i) Arm A: completed CTSA then PBA of OHIP-14, or ii) Arm B: PBA and then CTSA of OHIP-14 within the same day. User preference and time taken to complete the assessments were recorded. Agreement between CTSA and PBA was determined using directional difference (DD), absolute difference (AD), and intraclass correlation coefficient (ICC). Results:There was no significant difference in CTSA and PBA OHIP-14 scores (P>0.05). The magnitude of the DD in scores between assessment methods was small for overall scores and all domains (<0.3). The AD in OHIP-14 scores was small (~6% for overall score, between 8-16% for domains). Agreement between CTSA and PBA was high (ICC=0.9; 95% CI=0.8-0.9) for overall OHIP-14 scores, but ICC values varied across domains. Most (78%) preferred CTSA. There was no significant difference in time taken to complete assessments (P=0.09). Regression analyses did not identify any significant socio-demographic factor associated with absolute difference between CTSA and PBA scores. Conclusion:There is equivalence of measurements in OHRQoL assessments from CTSA and PBA, and the time taken to complete assessment by either means is similar. There is a greater preference for CTSA. This has implications to support the use of CTSA in OHRQoL assessments.

SUBMITTER: Anowar M

PROVIDER: S-EPMC7269662 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Measurement Equivalence of "Touch-Screen" versus "Paper-Based" Assessments of OHRQoL: A Randomized Crossover Trial.

Anowar Maznurfarhatunnisak M McGrath Colman C Saub Roslan R

Clinical, cosmetic and investigational dentistry 20200529

<h4>Purpose</h4>To determine the measurement equivalence of computer touch screen assessment (CTSA) and paper based assessment (PBA) of the oral health impact profile (OHIP-14).<h4>Patients and methods</h4>A randomized crossover trial was conducted. Sixty participants were randomized to either i) Arm A: completed CTSA then PBA of OHIP-14, or ii) Arm B: PBA and then CTSA of OHIP-14 within the same day. User preference and time taken to complete the assessments were recorded. Agreement between CTS ...[more]

PMID: 32581597

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Project description:Regulations, study design complexity and amounts of collected and shared data in clinical trials render efficient data handling procedures inevitable. Recent research suggests that electronic data capture can be key in this context but evidence is insufficient. This randomized controlled parallel group study tested the hypothesis that time efficiency is superior when electronic (eCRF) instead of paper case report forms (pCRF) are used for data collection. We additionally investigated predictors of time saving effects and data integrity.This study was conducted on top of a clinical weight loss trial performed at a clinical research facility over six months. All study nurses and patients participating in the clinical trial were eligible to participate and randomly allocated to enter cross-sectional data obtained during routine visits either through pCRF or eCRF. A balanced randomization list was generated before enrolment commenced. 90 and 30 records were gathered for the time that 27 patients and 2 study nurses required to report 2025 and 2037 field values, respectively. The primary hypothesis, that eCRF use is faster than pCRF use, was tested by a two-tailed t-test. Analysis of variance and covariance were used to evaluate predictors of entry performance. Data integrity was evaluated by descriptive statistics.All randomized patients were included in the study (eCRF group n =?13, pCRF group n =?14). eCRF, as compared to pCRF, data collection was associated with significant time savings across all conditions (8.29?±?5.15 min vs. 10.54?±?6.98 min, p =?.047). This effect was not defined by participant type, i.e. patients or study nurses (F(1,112) =?.15, p =?.699), CRF length (F(2,112) =?.49, p =?.609) or patient age (Beta?=?.09, p =?.534). Additional 5.16?±?2.83 min per CRF were saved with eCRFs due to data transcription redundancy when patients answered questionnaires directly in eCRFs. Data integrity was superior in the eCRF condition (0 versus 3 data entry errors).This is the first study to prove in direct comparison that using eCRFs instead of pCRFs increases time efficiency of data collection in clinical trials, irrespective of item quantity or patient age, and improves data quality.Clinical Trials NCT02649907 .

Dataset Information

Measurement Equivalence of "Touch-Screen" versus "Paper-Based" Assessments of OHRQoL: A Randomized Crossover Trial.

Publications

Measurement Equivalence of "Touch-Screen" versus "Paper-Based" Assessments of OHRQoL: A Randomized Crossover Trial.

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