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Table 2 Methodological data for comparative studies included in the final analysis

From: Designs used in published therapeutic studies of rare superficial vascular anomalies: a systematic literature search

COMPARATIVE STUDIES

 

TOTAL

N = 32

RANDOMIZED

N = 25

NON-RANDOMIZED

N = 7

DESIGN

Trial design, n (%)

   

Parallel groups

21 (65.6)

19 (76.0)

2 (28.6)

Cross-over

2 (6.3)

1 (4.0)

1 (14.3)

Randomized placebo phase

2 (6.3)

2 (8.0)

0

Within-person

1 (3.1)

1 (4.0)

0

Delayed-start design

2 (6.3)

2 (8.0)

0

Observational run-in period

1 (3.1)

0

1 (14.3)

Challenge–dechallenge–rechallenge

1 (3.1)

0

1 (14.3)

Use of a historical control group

2 (6.3)

0

2 (28.6)

Studies reported design justifications, n (%)*

   

Yes

6 (18.8)

4 (16.0)

2 (28.6)

No

26 (81.3)

21 (84.0)

5 (71.4)

Blinding, n (%)

   

Participants only

2 (6.3)

2 (8.0)

0

Participants and care provider

4 (12.5)

4 (16.0)

0

Participants, care provider and outcome assessor

3 (9.4)

3 (12.0)

0

Outcome assessor only

4 (12.5)

4 (16.0)

0

Participants and outcome assessor

1 (3.1)

1 (4.0)

0

No blinding

10 (31.3)

7 (28.0)

3 (42.9)

Not specified

8 (25.0)

4 (16.0)

4 (57.1)

TREATMENT GROUPS

Number of groups, n (%)

   

1

8 (25.0)

8 (32.0)

NA

2

15 (46.9)

15 (60.0)

NA

3**

2 (6.3)

2 (8.0)

NA

Intervention type in the experimental group, n (%)

   

Parenteral drugs

2 (6.3)

2 (8.0)

0

Enteral drugs

10 (31.3)

7 (28.0)

3 (42.9)

Topical drugs

3 (9.4)

3 (12.0)

0

Interventional radiology

15 (46.9)

11 (44.0)

4 (57.1)

Physiotherapy

2 (6.3)

2 (8.0)

0

Control group treatment (n = 31)a, n (%)

   

Placebo, sham interventions

4 (12.5)

4 (16.0)

0

Active drugs

5 (15.6)

5 (20.0)

0

Interventional radiology

13 (40.6)

11 (44.0)

2 (28.6)

Physiotherapy

0

0

0

Surgery

1 (3.1)

0

1 (14.3)

Interventional radiology and surgery

1 (3.1)

0

1 (14.3)

No treatment

7 (21.9)

5 (20.0)

2 (28.6)

  1. aOne study did not have control group but had 2 experimental groups
  2. * Whether the authors explained and/or justified the use of their study design/methodology in their protocol or publication
  3. ** For one, it was different concentrations of the same treatment and for the other, the groups were composed as follows: treatment 1 vs. treatment 2 vs. both treatments 1 and 2