More Than a Decade Since the Latest CONSORT Non-inferiority Trials Extension: Do Infectious Diseases Trials Do Enough?

More than a decade after the Consolidated Standards of Reporting Trials group released a reporting items checklist for non-inferiority randomized controlled trials, the infectious diseases literature continues to underreport these items. Trialists, journals, and peer reviewers should redouble their efforts to ensure infectious diseases studies meet these minimum reporting standards.

Methodological and Reporting Quality of Noninferiority Randomized Controlled Trials Comparing Antiretroviral Therapies: A Systematic Review.

BACKGROUND: It is unclear whether the reporting quality of antiretroviral (ARV) noninferiority (NI) randomized controlled trials (RCTs) has improved since the CONSORT guideline release in 2006. The primary objective of this systematic review was assessing the methodological and reporting quality of ARV NI-RCTs. We also assessed reporting quality by funding source and publication year. METHODS: We searched Medline, Embase, and Cochrane Central from inception to 14 November 2022. We included NI-RCTs comparing ≥2 ARV regimens used for human immunodeficiency virus treatment or prophylaxis. We used the Cochrane Risk of Bias 2.0 tool to assess risk of bias. Screening and data extraction were performed blinded and in duplicate. Descriptive statistics were used to summarize data; statistical tests were 2 sided, with significance defined as P < .05. The systematic review was prospectively registered (PROSPERO CRD42022328586), and not funded. RESULTS: We included 160 articles reporting 171 trials. Of these articles, 101 (63.1%) did not justify the NI margin used, and 28 (17.5%) did not provide sufficient information for sample size calculation. Eighty-nine of 160 (55.6%) reported both intention-to-treat and per-protocol analyses, while 118 (73.8%) described missing data handling. Ten of 171 trials (5.9%) reported potentially misleading results. Pharmaceutical industry-funded trials were more likely to be double-blinded (28.1% vs 10.3%; P = .03) and to describe missing data handling (78.5% vs 59.0%; P = .02). The overall risk of bias was low in 96 of 160 studies (60.0%). CONCLUSIONS: ARV NI-RCTs should improve NI margin justification, reporting of intention-to-treat and per-protocol analyses, and missing data handling to increase CONSORT adherence.

A first case of prosthetic joint infection with Actinomyces radingae.

Prosthetic joint infection is a common clinical orthopedic problem but infections caused by Actinomyces species have been rarely reported. An increasing number of reports identifying Actinomyces in cases of prosthetic joint infection suggest it may be an emerging pathogen. We describe here the first known case of a prosthetic joint infection caused by Actinomyces radingae.

A pilot model of a public-private partnership for implementation of a coronavirus disease 2019 (COVID-19) diagnostic testing program to facilitate a safe school reopening.

Objective: We developed an implementation plan to integrate diagnostic testing for coronavirus disease 2019 (COVID-19) into a public school system. Implementation barriers were identified and strategies were mapped to overcome them. Design: A COVID-19 diagnostic testing program leveraging a public-private partnership was developed for a public school system. Setting: A suburban school district and a local hospital during the 2020-2021 academic year. Methods: Using Consolidated Framework for Implementation Research (CFIR) constructs and evidenced-based implementation strategies, the program was designed as a "closed system" and was adapted based on stakeholder feedback. Implementation barriers and facilitators were identified and mapped to CFIR constructs to provide insights into factors influencing program adoption. Results: Preimplementation stages of engagement, feasibility, and readiness planning were completed. The program did not progress to implementation due to multiple factors, including changes in school leadership (inner setting and process-level constructs), improved access to outside testing, and lack of an existing paradigm for in-school testing (external constructs). Limited support from key stakeholders and opinion leaders was also a barrier (process-level construct). Conclusions: Although this locally initiated program did not progress beyond the preimplementation stage, the processes developed and barriers identified may be useful to inform planning efforts in other testing programs within public school systems. Future programs may consider incorporating multiplex diagnostic testing for influenza in addition to COVID-19. With relaxation of infection control measures, the prevalence of other respiratory viruses will increase. Actionable results will be needed to inform decisions about closures and quarantines.