|
Author, Year
|
Quality Criteria Fulfilled in StudiesI
|
Participants
|
ARII
|
|---|
| |
A)
|
B)
|
C)
|
D)
|
E)
|
F)
|
G)
|
H)
|
I)
|
J)
|
K)
| | |
|---|
|
Tröger 2009 [47]
|
+
|
-
|
-
|
(+)
|
+
|
+
|
+
|
+
|
(+)
|
(+)
|
+
|
95
|
6%
|
|
Büssing 2008 [48]
|
+III
|
-III
|
-III
|
-III
|
(-)III
|
-III
|
(-)III
|
(-)III
|
(-)III
|
(-)III
|
-III
|
65
|
No data
|
|
Grossarth 2008a [49]
|
+
|
+
|
-
|
(-)
|
+
|
(-)
|
+
|
(+)
|
+
|
+
|
-
|
76
|
21%
|
|
Grossarth 2008b [49]
|
+
|
+
|
-
|
(-)
|
+
|
+
|
+
|
(+)
|
+
|
+
|
-
|
52
|
0%
|
|
Grossarth 2007a [50]
|
+
|
+
|
-
|
(-)
|
+
|
(-)
|
+
|
(+)
|
+
|
+
|
-
|
50
|
16%
|
|
Grossarth 2007b [50]
|
+
|
+
|
-
|
(-)
|
+
|
(-)
|
+
|
(+)
|
+
|
+
|
-
|
48
|
17%
|
|
Grossarth 2007c [51]
|
+
|
+
|
-
|
(-)
|
+
|
+
|
+
|
(+)
|
+
|
+
|
-
|
38
|
0%
|
|
Grossarth 2006a [52, 53]
|
+
|
+
|
-
|
(-)
|
+
|
(-)
|
+
|
(+)
|
+
|
+
|
-
|
118
|
36%
|
|
Semiglasov 2006 [54]
|
+
|
-
|
(+)
|
(+)
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
352
|
4%
|
|
Auerbach 2005 [55]
|
+
|
-
|
(+)
|
(+)
|
+
|
-
|
+
|
(+)
|
+
|
(+)
|
+
|
23
|
30%
|
|
Piao 2004 [56]
|
+
|
+
|
-
|
(-)
|
+
|
+
|
+
|
(+)
|
+
|
+
|
+
|
233
|
4%
|
|
Semiglasov 2004 [57]
|
+
|
-
|
(+)
|
(+)
|
+
|
+
|
+
|
+
|
+
|
+
|
+
|
272
|
4%
|
|
Borrelli 2001 [58]
|
+
|
-
|
(+)
|
(+)
|
+
|
+
|
(+)
|
+
|
(-)
|
(+)
|
-
|
30
|
0%
|
|
Grossarth 2001a [59]
|
+
|
+
|
-
|
(-)
|
+
|
+
|
+
|
(-)
|
+
|
+
|
-
|
34
|
0%
|
|
Grossarth 2001b [59]
|
+
|
+
|
-
|
(-)
|
+
|
(-)
|
+
|
(-)
|
+
|
+
|
-
|
98
|
20%
|
|
Kim 1999 [60]
|
+
|
-
|
-
|
-
|
(-)
|
-
|
(+)
|
(+)
|
(-)
|
(-)
|
-
|
30IV
|
13%
|
|
Heiny 1991 [61]
|
+
|
-
|
(-)
|
(-)
|
+
|
(+)
|
+
|
(+)
|
+
|
+
|
-
|
46
|
13%
|
|
Gutsch 1988 [62]
|
+
|
-
|
-
|
(-)
|
+
|
(-)
|
+
|
+
|
(+)
|
+
|
-
|
692
|
20%
|
|
Lange 1985 [63]
|
+
|
+
|
-
|
(-)
|
+
|
(-)
|
+
|
(+)
|
+
|
+
|
-
|
68
|
35%
|
- I A) Protection against selection bias, especially by adequate randomization
- B) Minimization of heterogeneity by pre-stratification or matching
- C) Protection against observer bias by blinding of patient, care provider, and outcome assessor
- D) Protection against performance (treatment) bias by standardization of care protocol, documentation of all co-interventions, blinding of patients and care providers
- E) Protection against measurement (detection) bias by standardization of outcome assessment
- F) Protection against attrition (exclusion) bias, lost patients <10% or by intention-to-treat analysis (including non-adherers as randomized) plus per-protocol analysis (excluding non-adherers) in combination with sensitivity analysis, and by comparison of prognostic characteristics of lost patients and compliers
- G) Effect measurement relevant and well described
- H) Well-described intervention, patient characteristics, disease (diagnosis, stage, duration), previous therapy
- I) Well-described study design
- J) Well-described results
- K) Data quality assured by ICH-GCP guidelines, especially by monitoring
- + = adequately fulfilled, (+) = partly fulfilled, (-) = little fulfilled, - = not fulfilled
- II AR: attrition rate (dropouts, protocol deviations, withdrawals, patients did not receive treatment as allocated).
- III Assessment based only on an abstract
- IV Discrepancy in patient numbers in two presentations (30 and 33), with corresponding discrepancy of results
