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Table 2 Summary of results: quality and agreement

From: Using routinely recorded data in a UK RCT: a comparison to standard prospective data collection methods

Variable

Total eligible

SANAD II total

Routine total

Difference*

Agreement**

Acceptable agreement***

Data variables relevant to the identification of eligible individuals and baseline assessment in SANAD II

 First-ever seizure (all Types)

62

62 (100%)

23 (37.1%)

P=0.002

BA: − 84.09

(− 313.12–144.94)

30 days

 First-ever seizure (tonic-clonic)

62

43 (69.4%)

22 (35.5%)

P=0.043

BA: − 28.07

(− 123.72–67.58)

30 days

 Diagnosis of epilepsy (baseline)

78

78 (100%)

37 (47.4%)

P=0.004

BA: 30.54

(− 106.17–167.25)

30 days

 Diagnosis of epilepsy (all-time)

81

81 (100%)

47 (58.0%)

P=0.195

BA: − 26.23

(− 294.10–241.64)

30 days

 Classification of seizures (baseline)

37

37 (100%)

37 (100%)

N/A

CK: 0.151

(P=0.018)

N/A

 Classification of seizures (all-time)

47

47 (100%)

47 (100%)

N/A

CK: 0.123

(P=0.019)

N/A

 Clinical investigations

 Magnetic resonance imaging

98

72 (73.5%)

9 (9.2%)

N/A

CK: 0.016

(P=0.602)

N/A

 Clinical investigations

 Computed tomography

98

33 (33.7%)

27 (27.6%)

N/A

CK: 0.406

(P< 0.001)

N/A

 Clinical investigations

 Electroencephalography

23

18 (78.2%)

8 (34.8%)

N/A

CK: 0.188

(P=0.131)

N/A

Data variables relevant to the follow-up in SANAD II

 Date of first follow-up seizure

98

61 (62.2%)

22 (22.4%)

P=0.024

BA: − 86.26

(− 386.41–213.89)

30 Days

 Date of first follow-up tonic-clonic seizure

98

35 (35.7%)

20 (20.4%)

P=0.374

BA: − 9.20

(− 436.46–418.06)

30 Days

 Date 12-month remission achieved

98

46 (46.9%)

74 (75.5%)

P=0.004

BA: 34.24

(− 115.48–183.96)

30 Days

 Date of AED first prescription

26

26

25

P< 0.001

BA: − 19.76

(− 67.86–28.34)

90 Days

 Adverse events

97

97

2

-

-

-

 Planned healthcare attendances

 Baseline assessment

98

98 (100%)

87 (88.8%)

P< 0.001

BA: 1.67

(− 7.21–10.55)

N/A

 Planned healthcare attendances

 Follow-up assessments

350

350 (100%)

317 (90.6%)

P< 0.14

BA: 0.07

(− 4.33–4.47)

N/A

 Unplanned attendances: emergency

94

52 (55.3%)

37 (39.4%)

P=0.051

BA: 0.05

(− 0.734–0.834)

N/A

 Unplanned attendances: inpatient

94

12 (12.8%)

19 (20.2%)

P=0.098

BA: − 0.02

(− 0.72–0.68)

N/A

Outcomes relevant to the follow-up in SANAD II

Variable

Total eligible

SANAD II total

Routine total

SANAD II mean (95% CI)

Routine mean

(95% CI)

Difference****

 Days to first follow-up seizure

98

61 (62.2%)

22 (22.4%)

325 (258–393)

751 (680–822)

P< 0.001

 Days to 12-month remission

98

46 (46.9%)

74 (75.5%)

567 (515–618)

393 (375–410)

P< 0.001

  1. *Paired T test (normally distributed data), Wilcoxon signed-rank (non-normally distributed data)
  2. **Bland-Altman methods (BA) (continuous data) = mean (lower 95% confidence limit of agreement–upper 95% confidence limit of agreement)
  3. **Cohen kappa (CK) (categorical data) = 0.01–0.20 as none to slight agreement, 0.21–0.40 as fair, 0.41– 0.60 as moderate, 0.61–0.80 as substantial and 0.81–1.00 as almost perfect agreement
  4. ***Acceptable clinical limit of agreement specified a priori
  5. ****Log-rank test