| Literature DB >> 31404088 |
Vivienne X Guan1,2, Yasmine C Probst1,2, Elizabeth P Neale1,2, Linda C Tapsell1,2.
Abstract
BACKGROUND: High quality dietary intake data is required to support evidence of diet-disease relationships exposed in clinical research. Source data verification may be a useful quality assurance method in this setting. The present pilot study aimed to apply source data verification to evaluate the quality of the data coding process for dietary intake in a clinical trial and to explore potential barriers to data quality in this setting.Entities:
Mesh:
Year: 2019 PMID: 31404088 PMCID: PMC6690518 DOI: 10.1371/journal.pone.0221047
Source DB: PubMed Journal: PLoS One ISSN: 1932-6203 Impact factor: 3.240
Fig 1Participant flow of obtaining study consent from the trial dietitians in the food-based trial.
Fig 2The source data verification flow of procedures1, 2.
Definitions and examples of discrepancy types [38, 39].
| Discrepancy type | Definition | Example |
|---|---|---|
| Incorrect | Recorded on source document coded incorrectly or not related to items to the data destination | Recorded as two cups of bean stir fry and coded as one cup |
| Missed/missing | Recorded on source document but not coded to the data destination | Recorded two cups of bean stir fry but not coded to database |
| Sourceless | Not recorded on source data documents, but the data destination contains an entry | The quantity of bean stir fry not recorded on CRF, database record shows one cup |
| Questionable | Mismatch between source data documents and the data destination or detail of ingredients for a dish are listed on source data documents but pre-defined dish selected in the data destination | Recorded as bean stir fry in CRF, and transcribed as bean (mixed and canned) in the database |
1CRF: case report form
Discrepancies identified from the transcripts were then re-coded in FoodWorks and outputs were compared with the original FoodWorks entries, and intakes of energy and macronutrients (protein, total fat, carbohydrate and fibre) were explored. Those discrepancies unable to be re-coded were retained in the software in their original form.
Relevant number of data points, discrepancy type, number of discrepancies and discrepancy rate.
| Item | Quantity | Frequency | Total | |
|---|---|---|---|---|
| 88.15±31.77 | 67.05±24.37 | 75.15±29.21 | 230.35±80.46 | |
| 86.8±31.21 | 72.45±26.10 | 86.55±31.55 | 245.80±85.48 | |
| 87.2±30.78 | 87.2±30.78 | 87.20±30.78 | 261.60±92.33 | |
| p = 0.431 | p<0.0005 | p<0.0005 | p<0.0005 | |
| 1.35±0.72 | -5.40±1.65 | -11.40±2.79 | -15.45±3.00 | |
| 9 (10.59%) | 24 (16.55%) | 95 (27.70%) | 128 (22.34%) | |
| 47 (55.29%) | 5 (3.45%) | 5 (1.46%) | 57 (9.95%) | |
| 20 (23.53%) | 113 (77.93%) | 233 (67.93%) | 366 (63.87%) | |
| 9 (10.59%) | 3 (2.07%) | 10 (2.92%) | 22 (3.84%) | |
| 85 (4.82%) | 145 (8.22%) | 343 (19.46%) | 573 (32.50%) | |
| 0.95±1.43 | -20.15±4.26 | -12.05±2.71 | -31.25±6.14 | |
| 23 (15.75%) | 45 (9.51%) | 106 (27.97%) | 174 (17.43%) | |
| 62 (42.47%) | 12 (2.54%) | 11 (2.90%) | 85 (8.52%) | |
| 43 (29.45%) | 415 (87.74%) | 252 (66.49%) | 710 (71.14%) | |
| 18 (12.33%) | 1 (0.21%) | 10 (2.64%) | 29 (2.91%) | |
| 146 (8.41%) | 473 (27.25%) | 379 (21.83%) | 998 (57.49%) | |
| -0.40±1.12 | -14.75±4.10 | -0.65±0.83 | -15.80±4.92 | |
| 14 (22.58%) | 24 (7.16%) | 31 (55.36%) | 69 (15.23%) | |
| 15 (24.19%) | 8 (2.39%) | 6 (10.71%) | 29 (6.40%) | |
| 23 (37.10%) | 303 (90.45%) | 19 (33.93%) | 345 (79.16%) | |
| 10 (16.13%) | 0 (0%) | 0 (0%) | 10 (2.21%) | |
| 62 (3.56%) | 335 (19.21%) | 56 (3.21%) | 453 (25.97%) | |
1CRFs: case report forms
2p values are for differences in the number of data points among the transcripts, CRFs and food output of FoodWorks in food items, quantities and frequencies.
3Mean ± Standard deviation
Fig 3Percent of “incorrect” discrepancies identified in each food groups2,3.
Fig 4Identified themes affecting the quality of dietary intake data coding process under the main barrier Level of detail.