Appendix B

Technology assessment on negative pressure wound therapy devices.

 

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

  1. Were patients randomly assigned to the study's groups?
  2. Did the study use appropriate randomization methods?
  3. Was there concealment of group allocation?
  4. For non-randomized trials, did the study employ any other methods to enhance group comparability?
  5. Was the process of assigning patients to groups made independently from physician and patient preference?
  6. Did patients in different study groups have similar levels of performance on the outcome of interest at the time they were assigned to groups?
  7. Were the study groups comparable for all other important factors at the time they were assigned to groups?
  8. Did the study enroll all suitable patients or consecutive suitable patients within a time period?
  9. Was the comparison of interest prospectively planned?
  10. If patients received ancillary treatment(s), was there a ≤5% difference between groups in the proportion of patients receiving each specific ancillary treatment?
  11. Were the two groups treated concurrently?
  12. Was compliance with treatment ≥85% in both of the study's groups?
  13. Were patients blinded to the treatment they received?
  14. Was the healthcare provider blinded to the groups to which the patients were assigned?
  15. Were those who assessed the patient's outcomes blinded to the group to which the patients were assigned?
  16. Was the integrity of blinding of patients, physicians or outcome raters tested and found to be preserved?
  17. Was the outcome measure of interest objective and was it objectively measured?
  18. Was a standard instrument used to measure the outcome?
  19. Was there ≤15% difference in the length of follow-up for the two groups?
  20. Did ≥85% of the patients complete the study?
  21. Was there a ≤15% difference in completion rates in the study's groups?
  22. 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

StudiesYearQ1Q2Q3Q4Q5Q6Q7Q8Q9Q10Q11Q12
Timmers et al.(106)2009NNNNNNRYYNYNNR
Blume et al.(108)2008YYYYYYYNRYYYY
Gabriel et al.(339)2008NNNNNNYNNYNNR
Korber et al.(340)2008NNNNNNNNNYNNR
Ozturk et al.(117)2008NNNNNRNRNRYYYYY
Rinker et al.(121)2008NNNNNNRYYNYNRNR
Simek et al.(123)2008NNNNNYYNRNYNNR
Armstrong et al.(109)2007YNRYYYYYNRYYYNR
Denzinger et al.(135)2007NNNNNYYNRNYNNR
Lavery et al.(341)2007NNNYNNNNRNYNNR
Moues et al.(136)2007YYNRYYNNNRYNYNR
Siegel et al.(119)2007NNNNNNNNNYNNR
Braakenburg et al.(114)2006YYNRYYYYYYNRYY
Huang et al.(127)2006NNNNNRYYNNYNRNR
Stannard et al.(125)2006YYNRYYNNNNYYNR
Vuerstaek et al.(115)2006YYYYYYYNRYYYNR
Yang et al.(72)2006NNNNNNRNRYNYNNR
Bickels et al.(134)2005NNNNNNRNRYNYNNR
Fuchs et al.(23)2005NNNNNNRYYNYNNR
Immer et al.(130)2005NNNNNNNNNYNRNR
Schwien et al.(126)2005NNNNNNRNRNRNRNRNRNR
Segers et al.(122)2005NNNNNNNNYNNRN
Sjogren et al.(139)2005NNNNNYNYNYNRNR
Vidrine et al.(342)2005NNNNNYNYYYYNR
Kamolz et al.(343)2004NNNNNNYYYYYNR
Labler et al.(71)2004NNNNNNRNRNNYNNR
Moisidis et al.(112)2004YNRNRYYYYNYYYY
Page et al.(1)2004NNNNNYYNNNRNRNR
Stone et al.(133)2004NNNNNYYNNYNRY
Shilt et al.(138)2004NNNNNRNRNRYNYNNR
Domkowski et al.(129)2003NNNNNNRNRNRNNRNRNR
Song et al.(124)2003NNNNNYYYNYNRNR
Wanner et al.(118)2003NNNNNNRNYNRYYNR
Doss et al.(128)2002NNNNNNRYNNYNRNR
Ford et al.(110)2002YYNRYYNRNRNRYYYNR
Scherer et al.(132)2002NNNNNNNYNYNRNR
Catarino et al.(137)2000NNNNNNRNYNYNRN
Joseph et al.(113)2000YYNYYNNRNRYNRYNR
McCallon et al.(120)2000NNNYYNRNRNRYYYNR
Genecov et al.(131)1998NNNNNYYNRYYYY
Percent of "Y" Responses22177272535453735823715

† Based on "change in wound area/volume" as the reference outcome.

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Table 15a. Answers to Quality Assessment of Controlled Studies Comparing NPWT to Comparative Treatments

StudiesYearQ13Q14Q15Q16Q17Q18Q19Q20Q21Q22Overall Score
Timmers et al.(106)2009NNNRNYYNRYYY4.54
Blume et al.(108)2008NNNNNYYNYN6.59*
Gabriel et al.(339)2008NNNNYYYYYN3.41*
Korber et al.(340)2008NNNNNRNRYYYNR2.72**
Ozturk et al.(117)2008NNNNNNYYYNR4.54**
Rinker et al.(121)2008NNNNYYNRYYY4.54
Simek et al.(123)2008NNNNYYYYYNR4.09**
Armstrong et al.(109)2007NNYNYYYYYN7.95*
Denzinger et al.(135)2007NNRNRNNRNRYYYY4.50
Lavery et al.(341)2007NNRNRNNRNRYNRNRN3.18*
Moues et al.(136)2007NNNNYYYYYN5.68*
Siegel et al.(119)2007NNRNRNNRNRNRYYNR2.95**
Braakenburg et al.(114)2006NNNNYYYNNN6.4*
Huang et al.(127)2006NNRNRNNRNRNRNRNRNR3.86**
Stannard et al.(125)2006NNNNYYYYYN5.45*
Vuerstaek et al.(115)2006NNNNYYYNYNR7.04**
Yang et al.(72)2006NNNNNRNRNRYYNR3.41**
Bickels et al.(134)2005NNNNNRNRNRYYY3.63
Fuchs et al.(23)2005NNNNYYYYYNR4.32**
Immer et al.(130)2005NNNNYYNYYNR2.95**
Schwien et al.(126)2005NNRNRNNRNRNRNRNRN3.18*
Segers et al.(122)2005NNNNYYYNNNR2.27**
Sjogren et al.(139)2005NNNNYYNYYY4.09
Vidrine et al.(342)2005NNNNYYYYYNR5.0**
Kamolz et al.(343)2004NNNRNRYYYYYNR5.45**
Labler et al.(71)2004NNNRNYYNYYNR3.41**
Moisidis et al.(112)2004NNYNNNYYYNR6.59**
Page et al.(1, 112)2004NRNRNRNNRNRNYYNR3.86**
Stone et al.(133)2004NNNNYNRNRYYNR4.09**
Shilt et al.(138)2004NNNRNNYYYYY4.32
Domkowski et al.(139)2003NNNNYYNRNRNRNR3.18**
Song et al.(124)2003NNNNYYYYYY5.00
Wanner et al.(118)2003NNRNNYYYYYNR4.77**
Doss et al.(128)2002NNNNNNRNRNRNRNR2.72**
Ford et al.(110)2002NNRYNRYYYYNRN7.27*
Scherer et al.(132)2002NNNNYNRYYYNR3.63**
Catarino et al.(137)2000NNNNYYYYYNR4.09**
Joseph et al.(113)2000NNYNYYYYYNR6.6**
McCallon et al.(120)2000NNNRNYYYYYN5.68*
Genecov et al.(131)1998NNYNYYYNYY5.45
Percent of "Y" Responses00120656565778220 
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

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Table 15b. Answers to Quality Assessment of a Controlled Study Comparing NPWT to a Redon Bottle

StudiesYearQ1Q2Q3Q4Q5Q6Q7Q8Q9Q10Q11Q12
Wild et al. (116)2008YYYYYYYYYYYNR

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Table 15c. Answers to Quality Assessment of a Controlled Study Comparing NPWT to a Redon Bottle
StudiesYearQ13Q14Q15Q16Q17Q18Q19Q20Q21Q22Overall Score
Wild et al. (116)2008NNRYNYYYYYY8.64

Based on "change in wound area/volume" as the reference outcome

Current as of November 2009
Internet Citation: Appendix B. November 2009. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/research/findings/ta/negative-pressure-wound-therapy/appendix-b.html