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Design Characteristics and Recruitment Rates for Randomized Trials of Peri-Prosthetic Joint Infection Management: A Systematic Review

Prosthetic joint infections (PJI) present a major management challenge for practicing orthopedic surgeons and infectious disease physicians. There are few high-quality data to inform treatment guidelines. The aim of this systematic review was to report the design characteristics and recruitment rate...

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Autores principales: Manning, Laurens, Allen, Bethwyn, Davis, Joshua S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10604750/
https://www.ncbi.nlm.nih.gov/pubmed/37887189
http://dx.doi.org/10.3390/antibiotics12101486
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author Manning, Laurens
Allen, Bethwyn
Davis, Joshua S.
author_facet Manning, Laurens
Allen, Bethwyn
Davis, Joshua S.
author_sort Manning, Laurens
collection PubMed
description Prosthetic joint infections (PJI) present a major management challenge for practicing orthopedic surgeons and infectious disease physicians. There are few high-quality data to inform treatment guidelines. The aim of this systematic review was to report the design characteristics and recruitment rates for randomized controlled trials (RCTs) of PJI management. Trials were considered eligible for inclusion if human participants were randomized to any management intervention for PJI. We searched Medline, PubMed, Embase, Web of Science, Cochrane Database, ANZ Clinical Trials Registry, ClinicalTrials.gov, and the EU Clinical Trials Register until the end of May 2023. The systematic review was registered with PROSPERO (CRD42018112646). We identified 15 published RCTs with a total of 1743 participants with PJI. The median (interquartile range [IQR]) number of successfully recruited participants was 63 (38–140), with 0.28 (0.13–0.96) enrolments per site per month. Only four trials (36.4%) achieved the target recruitment. All RCTs applied different primary endpoints and varying definitions of a ‘good’ outcome. Despite recent improvements, PJI RCTs are characterized by slow recruitment and heterogeneous endpoint assessments, which preclude synthesis in a standard meta-analytic framework. To inform international guidelines, future PJI trials should be run as multi-country trials at high-recruiting sites.
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spelling pubmed-106047502023-10-28 Design Characteristics and Recruitment Rates for Randomized Trials of Peri-Prosthetic Joint Infection Management: A Systematic Review Manning, Laurens Allen, Bethwyn Davis, Joshua S. Antibiotics (Basel) Systematic Review Prosthetic joint infections (PJI) present a major management challenge for practicing orthopedic surgeons and infectious disease physicians. There are few high-quality data to inform treatment guidelines. The aim of this systematic review was to report the design characteristics and recruitment rates for randomized controlled trials (RCTs) of PJI management. Trials were considered eligible for inclusion if human participants were randomized to any management intervention for PJI. We searched Medline, PubMed, Embase, Web of Science, Cochrane Database, ANZ Clinical Trials Registry, ClinicalTrials.gov, and the EU Clinical Trials Register until the end of May 2023. The systematic review was registered with PROSPERO (CRD42018112646). We identified 15 published RCTs with a total of 1743 participants with PJI. The median (interquartile range [IQR]) number of successfully recruited participants was 63 (38–140), with 0.28 (0.13–0.96) enrolments per site per month. Only four trials (36.4%) achieved the target recruitment. All RCTs applied different primary endpoints and varying definitions of a ‘good’ outcome. Despite recent improvements, PJI RCTs are characterized by slow recruitment and heterogeneous endpoint assessments, which preclude synthesis in a standard meta-analytic framework. To inform international guidelines, future PJI trials should be run as multi-country trials at high-recruiting sites. MDPI 2023-09-27 /pmc/articles/PMC10604750/ /pubmed/37887189 http://dx.doi.org/10.3390/antibiotics12101486 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Systematic Review
Manning, Laurens
Allen, Bethwyn
Davis, Joshua S.
Design Characteristics and Recruitment Rates for Randomized Trials of Peri-Prosthetic Joint Infection Management: A Systematic Review
title Design Characteristics and Recruitment Rates for Randomized Trials of Peri-Prosthetic Joint Infection Management: A Systematic Review
title_full Design Characteristics and Recruitment Rates for Randomized Trials of Peri-Prosthetic Joint Infection Management: A Systematic Review
title_fullStr Design Characteristics and Recruitment Rates for Randomized Trials of Peri-Prosthetic Joint Infection Management: A Systematic Review
title_full_unstemmed Design Characteristics and Recruitment Rates for Randomized Trials of Peri-Prosthetic Joint Infection Management: A Systematic Review
title_short Design Characteristics and Recruitment Rates for Randomized Trials of Peri-Prosthetic Joint Infection Management: A Systematic Review
title_sort design characteristics and recruitment rates for randomized trials of peri-prosthetic joint infection management: a systematic review
topic Systematic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10604750/
https://www.ncbi.nlm.nih.gov/pubmed/37887189
http://dx.doi.org/10.3390/antibiotics12101486
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