5. Disposition of Documents Submitted by Interested Stakeholders
Figure 5 is an attrition diagram that depicts the status of
documents that Interested Stakeholders submitted for possible
inclusion in the report.
The diagram begins with a box outlining the total submission
of 1435 documents. Several boxes ensue which are connected by
arrows going from top to bottom which follow the submissions
as they are being screened for possible inclusion in the report.
In the first frame, we remove duplicate submissions made by
all interested stakeholders. 638 duplicate submissions were identified.
An arrow leads from the 797 Unique Submissions to the Initial
Screening Phase where documents may be excluded, used in our Background Section or passed to the next level. In this instance,
269 documents were identified for exclusion. 147 were case reports,
abstracts, or poster presentations; two were product information;
28 were personal communications; and 92 were other documents
not relevant to the report.
29 documents were identified for inclusion in our Background Section and included 510(k) clearance information from the FDA
and information from product labels and brochures.
The path then follows the 499 full articles remaining. During
this phase of screening we do a more extensive screening of the
full articles which is based on our pre-determined inclusion/exclusion
criteria. Go to our Methods Section for
additional information on the criteria.
354 articles were excluded during this evaluation phase. 39 were
animal studies; four were cost analyses; ten were duplicate studies;
30 included fewer than 5 patients; 13 were guidelines; five were
homemade devices; four were in vitro studies; 152 were narrative
reviews; ten did not include relevant outcomes; five were not
clinical studies; 11 did not include a NPWT device; 28 were not
a NPWT study and 43 were excluded for Other Reasons which may
include "inclusion of healthy subjects", "lack
of reporting wound healing outcomes" or "patients
treated with dual therapies."
Of the 144 full articles remaining for possible inclusion in
the report; 117 were already identified in our literature searches.
Of the 27 articles that ultimately met the inclusion criteria
but were not identified in the literature searches; three studies
addressed Key Question 1; 23 studies were relevant to Key Question
3; and one was included as a systematic review of NPWT. In addition,
we included one unpublished study in Key Question 3 due to relevancy
of the article bringing a total of 24 studies that addressed
Key Question 3. Note: Language has been corrected to reflect
screening of meeting abstracts, poster presentations and other
documents in addition to abstracts of full articles.
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