Clinical Evaluation Systematic Literature Review - Apec-ahc.org
Clinical Evaluation Systematic Literature Review - Apec-ahc.org
Clinical Evaluation Systematic Literature Review - Apec-ahc.org
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APPENDIX B:<br />
A POSSIBLE METHODOLOGY FOR DOCUMENTING THE SCREENING AND SELECTION OF<br />
LITERATURE WITHIN A LITERATURE SEARCH REPORT 6<br />
Potentially relevant literature identified<br />
through the search<br />
(copy of all citations)<br />
<strong>Literature</strong> retrieved for more detailed<br />
assessment<br />
<strong>Literature</strong> with relevant useable data<br />
included in the clinical evaluation, by<br />
outcome:<br />
• Device performance*<br />
• Device safety*<br />
• Device comparability<br />
(if applicable)<br />
*some literature will address issue of both performance and safety<br />
___________________________________<br />
<strong>Literature</strong> excluded, with reasons<br />
<strong>Literature</strong> excluded from clinical<br />
evaluation, with reasons<br />
6 Adapted from Moher D, Cook DJ, Eastwood S, Olkin I, Rennie, D & Stroup DF. Improving the quality of reports and meta-analyses of randomised controlled trials: the QUORUM<br />
statement. Quality of Reporting of Meta-analyses. Lancet 1999; 354:1896-1900<br />
page 27 of 46<br />
MEDDEV 2.7.1 Rev. 3, page 27<br />
Methodology for <strong>Systematic</strong> <strong>Review</strong><br />
• Inclusion criteria for studies<br />
• Population<br />
• Adults of either gender<br />
• Intervention<br />
• Total Knee Replacement only<br />
• Outcome measures<br />
• <strong>Clinical</strong><br />
• Radiographic<br />
• Patient-related effectiveness and safety outcomes<br />
• Others<br />
22
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