Diversity in clinical trial inclusion for peripheral artery disease lower extremity endovascular interventions: a systematic review protocol
Aim: This review provides a study protocol for a systematic review of peripheral artery disease (PAD) clinical trials to examine the eligibility criteria, demographic representation, and enrollment strategies among PAD patients undergoing lower extremity (LE) endovascular interventions. Methods: T...
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Becaris Publishing Limited
2023-11-01
|
| Series: | Journal of Comparative Effectiveness Research |
| Subjects: |
| _version_ | 1827576754963742720 |
|---|---|
| author | Chandler Long Abimbola O Williams Caroline M Jacobsen Alysha M McGovern Liesl M Hargens Sue Duval Michael R Jaff |
| author_facet | Chandler Long Abimbola O Williams Caroline M Jacobsen Alysha M McGovern Liesl M Hargens Sue Duval Michael R Jaff |
| author_sort | Chandler Long |
| collection | DOAJ |
| description | Aim: This review provides a study protocol for a systematic review of peripheral artery disease (PAD) clinical
trials to examine the eligibility criteria, demographic representation, and enrollment strategies among
PAD patients undergoing lower extremity (LE) endovascular interventions. Methods: This systematic
review will be conducted according to the Cochrane Collaboration methodology for systematic reviews
and following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols (PRISMAP).
Eligible studies will include randomized controlled trials (RCTs) between January 2012 and December
2022. The primary outcome will be a description and summary of the frequency of the reporting of
demographic characteristics. The feasibility of a meta-analysis or meta-regression will be explored, but
if determined to be infeasible, the Synthesis Without Meta-analysis (SWiM) reporting guideline will be
followed for the reporting of findings. Discussion: The findings may help to quantify existing inequities
in clinical trial participation that may be addressed through optimizing enrollment strategies for future
PAD trials. Systematic review registration: PROSPERO (CRD42022378304) |
| first_indexed | 2024-03-08T21:16:57Z |
| format | Article |
| id | doaj.art-13f5d7bc4ec24b5e8f19fefff744eeb4 |
| institution | Directory Open Access Journal |
| issn | 2042-6313 |
| language | English |
| last_indexed | 2024-03-08T21:16:57Z |
| publishDate | 2023-11-01 |
| publisher | Becaris Publishing Limited |
| record_format | Article |
| series | Journal of Comparative Effectiveness Research |
| spelling | doaj.art-13f5d7bc4ec24b5e8f19fefff744eeb42023-12-21T14:19:15ZengBecaris Publishing LimitedJournal of Comparative Effectiveness Research2042-63132023-11-01121210.57264/cer-2023-0048Diversity in clinical trial inclusion for peripheral artery disease lower extremity endovascular interventions: a systematic review protocolChandler Long0Abimbola O Williams1https://orcid.org/0000-0003-1982-8417Caroline M Jacobsen2Alysha M McGovern3https://orcid.org/0000-0002-6486-1788Liesl M Hargens4https://orcid.org/0009-0005-4714-2326Sue Duval5https://orcid.org/0000-0003-1025-8665Michael R Jaff6https://orcid.org/0000-0002-3772-5887Duke Vascular & Endovascular Surgery, Duke University Medical Center, Duke University, Durham, NC 27707, USAHealth Economics and Market Access, Boston Scientific, Marlborough, MA 01752, USAHealth Economics and Market Access, Boston Scientific, Marlborough, MA 01752, USAHealth Economics and Market Access, Boston Scientific, Marlborough, MA 01752, USAHealth Economics and Market Access, Boston Scientific, Marlborough, MA 01752, USAHealth Economics and Market Access, Boston Scientific, Marlborough, MA 01752, USA; Division of Cardiology, Department of Medicine, University of Minnesota, Minneapolis, MN 55455, USAPeripheral Interventions, Boston Scientific, Maple Grove, MN 55133, USAAim: This review provides a study protocol for a systematic review of peripheral artery disease (PAD) clinical trials to examine the eligibility criteria, demographic representation, and enrollment strategies among PAD patients undergoing lower extremity (LE) endovascular interventions. Methods: This systematic review will be conducted according to the Cochrane Collaboration methodology for systematic reviews and following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols (PRISMAP). Eligible studies will include randomized controlled trials (RCTs) between January 2012 and December 2022. The primary outcome will be a description and summary of the frequency of the reporting of demographic characteristics. The feasibility of a meta-analysis or meta-regression will be explored, but if determined to be infeasible, the Synthesis Without Meta-analysis (SWiM) reporting guideline will be followed for the reporting of findings. Discussion: The findings may help to quantify existing inequities in clinical trial participation that may be addressed through optimizing enrollment strategies for future PAD trials. Systematic review registration: PROSPERO (CRD42022378304)peripheral artery diseasedemographic representationdiversityequity in healthcarelower extremity endovascular interventionssystematic reviewsclinical trials |
| spellingShingle | Chandler Long Abimbola O Williams Caroline M Jacobsen Alysha M McGovern Liesl M Hargens Sue Duval Michael R Jaff Diversity in clinical trial inclusion for peripheral artery disease lower extremity endovascular interventions: a systematic review protocol Journal of Comparative Effectiveness Research peripheral artery disease demographic representation diversity equity in healthcare lower extremity endovascular interventions systematic reviews clinical trials |
| title | Diversity in clinical trial inclusion for peripheral artery disease lower extremity endovascular interventions: a systematic review protocol |
| title_full | Diversity in clinical trial inclusion for peripheral artery disease lower extremity endovascular interventions: a systematic review protocol |
| title_fullStr | Diversity in clinical trial inclusion for peripheral artery disease lower extremity endovascular interventions: a systematic review protocol |
| title_full_unstemmed | Diversity in clinical trial inclusion for peripheral artery disease lower extremity endovascular interventions: a systematic review protocol |
| title_short | Diversity in clinical trial inclusion for peripheral artery disease lower extremity endovascular interventions: a systematic review protocol |
| title_sort | diversity in clinical trial inclusion for peripheral artery disease lower extremity endovascular interventions a systematic review protocol |
| topic | peripheral artery disease demographic representation diversity equity in healthcare lower extremity endovascular interventions systematic reviews clinical trials |
| work_keys_str_mv | AT chandlerlong diversityinclinicaltrialinclusionforperipheralarterydiseaselowerextremityendovascularinterventionsasystematicreviewprotocol AT abimbolaowilliams diversityinclinicaltrialinclusionforperipheralarterydiseaselowerextremityendovascularinterventionsasystematicreviewprotocol AT carolinemjacobsen diversityinclinicaltrialinclusionforperipheralarterydiseaselowerextremityendovascularinterventionsasystematicreviewprotocol AT alyshammcgovern diversityinclinicaltrialinclusionforperipheralarterydiseaselowerextremityendovascularinterventionsasystematicreviewprotocol AT lieslmhargens diversityinclinicaltrialinclusionforperipheralarterydiseaselowerextremityendovascularinterventionsasystematicreviewprotocol AT sueduval diversityinclinicaltrialinclusionforperipheralarterydiseaselowerextremityendovascularinterventionsasystematicreviewprotocol AT michaelrjaff diversityinclinicaltrialinclusionforperipheralarterydiseaselowerextremityendovascularinterventionsasystematicreviewprotocol |