Appendix B
Table 15. Answers to
Quality Assessment of Controlled Studies Comparing NPWT
to Comparative Treatments
Table 15a. Answers to Quality Assessment of Controlled
Studies Comparing NPWT to Comparative Treatments
Table 15b. Answers to Quality Assessment of a Controlled
Study Comparing NPWT to a Redon Bottle
Table 15c. Answers to Quality Assessment of a Controlled
Study Comparing NPWT to a Redon Bottle
Quality of Literature
ECRI Institute Study Quality Assessment Instrument
The following instrument was used to evaluate the quality
of the included studies. Because it was the most consistently
reported outcome, wound area reduction was the outcome for
which quality was assessed.
The final quality score was calculated: Yes = 1 point; No =
-1 point; NR = 0 point; the raw score was then converted to
a 0 to 10 scale by adding the number of questions, dividing
by double the number of questions, and then multiplying by
ten. Controlled trials with a score of less than 6 as Low quality,
greater than 6.0 up to 8.5 as Moderate quality, and greater
than 8.5 as High quality.
Quality Assessment Instrument for Controlled Trials
- Were patients randomly assigned to the study's groups?
- Did the study use appropriate randomization methods?
- Was there concealment of group allocation?
- For non-randomized trials, did the study employ any other
methods to enhance group comparability?
- Was the process of assigning patients to groups made independently
from physician and patient preference?
- Did patients in different study groups have similar levels
of performance on the outcome of interest at the time they
were assigned to groups?
- Were the study groups comparable for all other important
factors at the time they were assigned to groups?
- Did the study enroll all suitable patients or consecutive
suitable patients within a time period?
- Was the comparison of interest prospectively planned?
- If patients received ancillary treatment(s), was there
a ≤5% difference between groups in the proportion of patients
receiving each specific ancillary treatment?
- Were the two groups treated concurrently?
- Was compliance with treatment ≥85% in both of the study's
groups?
- Were patients blinded to the treatment they received?
- Was the healthcare provider blinded to the groups to which
the patients were assigned?
- Were those who assessed the patient's outcomes blinded
to the group to which the patients were assigned?
- Was the integrity of blinding of patients, physicians or
outcome raters tested and found to be preserved?
- Was the outcome measure of interest objective and was it
objectively measured?
- Was a standard instrument used to measure the outcome?
- Was there ≤15% difference in the length of follow-up
for the two groups?
- Did ≥85% of the patients complete the study?
- Was there a ≤15% difference in completion rates in the
study's groups?
- Was the funding for this study derived from a source that
would not benefit financially from results in a particular
direction?
Table 15. Answers to
Quality Assessment of Controlled Studies Comparing NPWT to
Comparative Treatments†
| Studies |
Year |
Q1 |
Q2 |
Q3 |
Q4 |
Q5 |
Q6 |
Q7 |
Q8 |
Q9 |
Q10 |
Q11 |
Q12 |
| Timmers et al.(106) |
2009 |
N |
N |
N |
N |
N |
NR |
Y |
Y |
N |
Y |
N |
NR |
| Blume et al.(108) |
2008 |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
NR |
Y |
Y |
Y |
Y |
| Gabriel et al.(263) |
2008 |
N |
N |
N |
N |
N |
N |
Y |
N |
N |
Y |
N |
NR |
| Korber et al.(264) |
2008 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Y |
N |
NR |
| Ozturk et al.(117) |
2008 |
N |
N |
N |
N |
NR |
NR |
NR |
Y |
Y |
Y |
Y |
Y |
| Rinker et al.(121) |
2008 |
N |
N |
N |
N |
N |
NR |
Y |
Y |
N |
Y |
NR |
NR |
| Simek et al.(123) |
2008 |
N |
N |
N |
N |
N |
Y |
Y |
NR |
N |
Y |
N |
NR |
| Armstrong et al.(109) |
2007 |
Y |
NR |
Y |
Y |
Y |
Y |
Y |
NR |
Y |
Y |
Y |
NR |
| Denzinger et al.(135) |
2007 |
N |
N |
N |
N |
N |
Y |
Y |
NR |
N |
Y |
N |
NR |
| Lavery et al.(265) |
2007 |
N |
N |
N |
Y |
N |
N |
N |
NR |
N |
Y |
N |
NR |
| Moues et al.(136) |
2007 |
Y |
Y |
NR |
Y |
Y |
N |
N |
NR |
Y |
N |
Y |
NR |
| Siegel et al.(119) |
2007 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Y |
N |
NR |
| Braakenburg et al.(114) |
2006 |
Y |
Y |
NR |
Y |
Y |
Y |
Y |
Y |
Y |
NR |
Y |
Y |
| Huang et al.(127) |
2006 |
N |
N |
N |
N |
NR |
Y |
Y |
N |
N |
Y |
NR |
NR |
| Stannard et al.(125) |
2006 |
Y |
Y |
NR |
Y |
Y |
N |
N |
N |
N |
Y |
Y |
NR |
| Vuerstaek et al.(115) |
2006 |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
NR |
Y |
Y |
Y |
NR |
| Yang et al.(72) |
2006 |
N |
N |
N |
N |
N |
NR |
NR |
Y |
N |
Y |
N |
NR |
| Bickels et al.(134) |
2005 |
N |
N |
N |
N |
N |
NR |
NR |
Y |
N |
Y |
N |
NR |
| Fuchs et al.(23) |
2005 |
N |
N |
N |
N |
N |
NR |
Y |
Y |
N |
Y |
N |
NR |
| Immer et al.(130) |
2005 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Y |
NR |
NR |
| Schwien et al.(126) |
2005 |
N |
N |
N |
N |
N |
NR |
NR |
NR |
NR |
NR |
NR |
NR |
| Segers et al.(122) |
2005 |
N |
N |
N |
N |
N |
N |
N |
N |
Y |
N |
NR |
N |
| Sjogren et al.(139) |
2005 |
N |
N |
N |
N |
N |
Y |
N |
Y |
N |
Y |
NR |
NR |
| Vidrine et al.(266) |
2005 |
N |
N |
N |
N |
N |
Y |
N |
Y |
Y |
Y |
Y |
NR |
| Kamolz et al.(267) |
2004 |
N |
N |
N |
N |
N |
N |
Y |
Y |
Y |
Y |
Y |
NR |
| Labler et al.(71) |
2004 |
N |
N |
N |
N |
N |
NR |
NR |
N |
N |
Y |
N |
NR |
| Moisidis et al.(112) |
2004 |
Y |
NR |
NR |
Y |
Y |
Y |
Y |
N |
Y |
Y |
Y |
Y |
| Page et al.(1) |
2004 |
N |
N |
N |
N |
N |
Y |
Y |
N |
N |
NR |
NR |
NR |
| Stone et al.(133) |
2004 |
N |
N |
N |
N |
N |
Y |
Y |
N |
N |
Y |
NR |
Y |
| Shilt et al.(138) |
2004 |
N |
N |
N |
N |
NR |
NR |
NR |
Y |
N |
Y |
N |
NR |
| Domkowski et al.(129) |
2003 |
N |
N |
N |
N |
N |
NR |
NR |
NR |
N |
NR |
NR |
NR |
| Song et al.(124) |
2003 |
N |
N |
N |
N |
N |
Y |
Y |
Y |
N |
Y |
NR |
NR |
| Wanner et al.(118) |
2003 |
N |
N |
N |
N |
N |
NR |
N |
Y |
NR |
Y |
Y |
NR |
| Doss et al.(128) |
2002 |
N |
N |
N |
N |
N |
NR |
Y |
N |
N |
Y |
NR |
NR |
| Ford et al.(110) |
2002 |
Y |
Y |
NR |
Y |
Y |
NR |
NR |
NR |
Y |
Y |
Y |
NR |
| Scherer et al.(132) |
2002 |
N |
N |
N |
N |
N |
N |
N |
Y |
N |
Y |
NR |
NR |
| Catarino et al.(137) |
2000 |
N |
N |
N |
N |
N |
NR |
N |
Y |
N |
Y |
NR |
N |
| Joseph et al.(113) |
2000 |
Y |
Y |
N |
Y |
Y |
N |
NR |
NR |
Y |
NR |
Y |
NR |
| McCallon et al.(120) |
2000 |
N |
N |
N |
Y |
Y |
NR |
NR |
NR |
Y |
Y |
Y |
NR |
| Genecov et al.(131) |
1998 |
N |
N |
N |
N |
N |
Y |
Y |
NR |
Y |
Y |
Y |
Y |
| Percent of "Y" Responses |
22 |
17 |
7 |
27 |
25 |
35 |
45 |
37 |
35 |
82 |
37 |
15 |
† Based on "change
in wound area/volume" as the reference outcome.
Return to Top
Table 15a. Answers
to Quality Assessment of Controlled Studies Comparing NPWT
to Comparative Treatments†
| Studies |
Year |
Q13 |
Q14 |
Q15 |
Q16 |
Q17 |
Q18 |
Q19 |
Q20 |
Q21 |
Q22 |
Overall Score |
| Timmers et al.(106) |
2009 |
N |
N |
NR |
N |
Y |
Y |
NR |
Y |
Y |
Y |
4.54 |
| Blume et al.(108) |
2008 |
N |
N |
N |
N |
N |
Y |
Y |
N |
Y |
N |
6.59* |
| Gabriel et al.(263) |
2008 |
N |
N |
N |
N |
Y |
Y |
Y |
Y |
Y |
N |
3.41* |
| Korber et al.(264) |
2008 |
N |
N |
N |
N |
NR |
NR |
Y |
Y |
Y |
NR |
2.72** |
| Ozturk et al.(117) |
2008 |
N |
N |
N |
N |
N |
N |
Y |
Y |
Y |
NR |
4.54** |
| Rinker et al.(121) |
2008 |
N |
N |
N |
N |
Y |
Y |
NR |
Y |
Y |
Y |
4.54 |
| Simek et al.(123) |
2008 |
N |
N |
N |
N |
Y |
Y |
Y |
Y |
Y |
NR |
4.09** |
| Armstrong et al.(109) |
2007 |
N |
N |
Y |
N |
Y |
Y |
Y |
Y |
Y |
N |
7.95* |
| Denzinger et al.(135) |
2007 |
N |
NR |
NR |
N |
NR |
NR |
Y |
Y |
Y |
Y |
4.50 |
| Lavery et al.(265) |
2007 |
N |
NR |
NR |
N |
NR |
NR |
Y |
NR |
NR |
N |
3.18* |
| Moues et al.(136) |
2007 |
N |
N |
N |
N |
Y |
Y |
Y |
Y |
Y |
N |
5.68* |
| Siegel et al.(119) |
2007 |
N |
NR |
NR |
N |
NR |
NR |
NR |
Y |
Y |
NR |
2.95** |
| Braakenburg et al.(114) |
2006 |
N |
N |
N |
N |
Y |
Y |
Y |
N |
N |
N |
6.4* |
| Huang et al.(127) |
2006 |
N |
NR |
NR |
N |
NR |
NR |
NR |
NR |
NR |
NR |
3.86** |
| Stannard et al.(125) |
2006 |
N |
N |
N |
N |
Y |
Y |
Y |
Y |
Y |
N |
5.45* |
| Vuerstaek et al.(115) |
2006 |
N |
N |
N |
N |
Y |
Y |
Y |
N |
Y |
NR |
7.04** |
| Yang et al.(72) |
2006 |
N |
N |
N |
N |
NR |
NR |
NR |
Y |
Y |
NR |
3.41** |
| Bickels et al.(134) |
2005 |
N |
N |
N |
N |
NR |
NR |
NR |
Y |
Y |
Y |
3.63 |
| Fuchs et al.(23) |
2005 |
N |
N |
N |
N |
Y |
Y |
Y |
Y |
Y |
NR |
4.32** |
| Immer et al.(130) |
2005 |
N |
N |
N |
N |
Y |
Y |
N |
Y |
Y |
NR |
2.95** |
| Schwien et al.(126) |
2005 |
N |
NR |
NR |
N |
NR |
NR |
NR |
NR |
NR |
N |
3.18* |
| Segers et al.(122) |
2005 |
N |
N |
N |
N |
Y |
Y |
Y |
N |
N |
NR |
2.27** |
| Sjogren et al.(139) |
2005 |
N |
N |
N |
N |
Y |
Y |
N |
Y |
Y |
Y |
4.09 |
| Vidrine et al.(266) |
2005 |
N |
N |
N |
N |
Y |
Y |
Y |
Y |
Y |
NR |
5.0** |
| Kamolz et al.(267) |
2004 |
N |
N |
NR |
NR |
Y |
Y |
Y |
Y |
Y |
NR |
5.45** |
| Labler et al.(71) |
2004 |
N |
N |
NR |
N |
Y |
Y |
N |
Y |
Y |
NR |
3.41** |
| Moisidis et al.(112) |
2004 |
N |
N |
Y |
N |
N |
N |
Y |
Y |
Y |
NR |
6.59** |
| Page et al.(1,112) |
2004 |
NR |
NR |
NR |
N |
NR |
NR |
N |
Y |
Y |
NR |
3.86** |
| Stone et al.(133) |
2004 |
N |
N |
N |
N |
Y |
NR |
NR |
Y |
Y |
NR |
4.09** |
| Shilt et al.(138) |
2004 |
N |
N |
NR |
N |
N |
Y |
Y |
Y |
Y |
Y |
4.32 |
| Domkowski et al.(139) |
2003 |
N |
N |
N |
N |
Y |
Y |
NR |
NR |
NR |
NR |
3.18** |
| Song et al.(124) |
2003 |
N |
N |
N |
N |
Y |
Y |
Y |
Y |
Y |
Y |
5.00 |
| Wanner et al.(118) |
2003 |
N |
NR |
N |
N |
Y |
Y |
Y |
Y |
Y |
NR |
4.77** |
| Doss et al.(128) |
2002 |
N |
N |
N |
N |
N |
NR |
NR |
NR |
NR |
NR |
2.72** |
| Ford et al.(110) |
2002 |
N |
NR |
Y |
NR |
Y |
Y |
Y |
Y |
NR |
N |
7.27* |
| Scherer et al.(132) |
2002 |
N |
N |
N |
N |
Y |
NR |
Y |
Y |
Y |
NR |
3.63** |
| Catarino et al.(137) |
2000 |
N |
N |
N |
N |
Y |
Y |
Y |
Y |
Y |
NR |
4.09** |
| Joseph et al.(113) |
2000 |
N |
N |
Y |
N |
Y |
Y |
Y |
Y |
Y |
NR |
6.6** |
| McCallon et al.(120) |
2000 |
N |
N |
NR |
N |
Y |
Y |
Y |
Y |
Y |
N |
5.68* |
| Genecov et al.(131) |
1998 |
N |
N |
Y |
N |
Y |
Y |
Y |
N |
Y |
Y |
5.45 |
| Percent
of "Y" Responses |
0 |
0 |
12 |
0 |
65 |
65 |
65 |
77 |
82 |
20 |
|
| Median
Score |
|
|
|
|
|
|
|
|
|
|
4.32 |
† Based on "change
in wound area/volume" as the reference outcome.
* Fully or partially funded
by KCI
** Conflict of interest not
reported
Top of Page
Table 15b. Answers
to Quality Assessment of a Controlled Study Comparing NPWT
to a Redon Bottle†
| Studies |
Year |
Q1 |
Q2 |
Q3 |
Q4 |
Q5 |
Q6 |
Q7 |
Q8 |
Q9 |
Q10 |
Q11 |
Q12 |
| Wild et al. (116) |
2008 |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
NR |
Top of Page
Table 15c. Answers to
Quality Assessment of a Controlled Study Comparing NPWT to a
Redon Bottle†
| Studies |
Year |
Q13 |
Q14 |
Q15 |
Q16 |
Q17 |
Q18 |
Q19 |
Q20 |
Q21 |
Q22 |
Overall Score |
| Wild et al. (116) |
2008 |
N |
NR |
Y |
N |
Y |
Y |
Y |
Y |
Y |
Y |
8.64 |
† Based
on "change in wound area/volume" as the reference
outcome
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