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Table 1 Patient and staff characteristics

From: Challenges of maintaining research protocol fidelity in a clinical care setting: A qualitative study of the experiences and views of patients and staff participating in a randomized controlled trial

Patients

4T

(n = 708)

Qualitative sample (n = 45)

Age

  

   Mean age (± SD)

61.7 (±9.8)*

64.7 (± 8.5)**

Sex

  

   Male (%)

456 (64)

29 (64)

   Female (%)

252 (36)

16 (36)

Randomisation

  

   Biphasic (%)

235 (33)

15 (33)

   Prandial (%)

239 (34)

15 (33)

   Basal (%)

234 (33)

15 (33)

Glycaemic control at Yr 3

  

   Median HbA1c

6.9%

6.9%

   Number (%) of patients with HbA1c £ 6.5%

283 (40)

19 (42)

   Number (%) of patients with HbA1c £ 7.0%

425 (60)

26 (58)

Health Care Professionals

4T ➢

Qualitative sample (n = 21)

   Role

  

   Physician (Phy)

-

9

   Research Nurse (RNs)

-

12

Experience in diabetic medicine

  

   0-5 years

-

1

   10+ years

-

8

Clinical background in diabetic nursing prior to 4-T (e.g. Diabetes Specialist Nurse)

  

   Yes

-

8

   No

-

4

Nurse role during 4-T

  

   Research only

-

6

   Research and clinical care

-

6

  1. Notes
  2. Percentages rounded up to nearest whole number
  3. * Age at initiation of 4T
  4. ** Age at interview
  5. ➢ Trial data not available