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Table 1 Pre vs Post-Intervention Change in DPU, DPMO, Yield and SIGMA

From: Reducing defects in the datasets of clinical research studies: conformance with data quality metrics

Measures

Pre-Intervention

n = 45

Post-Intervention

n = 21

Distribution of defects

 Zero defects

6 (13.3)

17 (81)

 One defect

8 (17.7)

2 (9.5)

 Two or more defects

31 (69)

2 (9.5)

DPU (defects per unit)

2.33

0.57

DPMO (defects per million opportunities)

194,444.44

47,619.04

Yield

80.55

95.23

SIGMA

2.4

3.2

 

Pre-intervention datasets

Post-intervention datasets

 

Not Defective

Defective

Not Defective

Defective

Data Capturing Points n (%)

 Single data capturing point (Cross-Sectional studies)

6 (28.6)

15 (71.4)

8 (66.7)

4 (33.3)

 Multiple data capturing points (Longitudinal studies)

0

24 (100)*

9 (100)

0

Research Coordinator on board n (%)

 No

5 (17.9)

23 (82.1)

7 (63.60)

4 (36.4)

 Yes

1 (5.9)

16 (94.1)

10 (100)

0

Principal Investigators (PIs) Requesting Data Analysis n(%)

 Returning PIs

3 (30)

7 (70)

14 (100)

0

 New PIs

3 (8.6)

32 (91.4)

3 (42.9)

4 (57.1)**

  1. Longitudinal studies = Cohort/Case-Control/Randomized controlled trials (RCT)
  2. The reported percentage is row percentage
  3. p -value is based on Fisher's exact test
  4. * p = 0.007
  5. **p = 0.006