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Individuals with an anterior cruciate ligament reconstruction (ACLR) commonly exhibit altered gait patterns, potentially contributing to an increased risk of osteoarthritis (OA). Joint moment contributions (JMCs) and support moments during incline and decline running are unknown in healthy young adults and individuals with an ACLR. Understanding these conditional joint-level changes could explain the increased incidence of OA that develops in the long term. Therefore, this knowledge may provide insight into the rehabilitation and prevention of OA development. We aimed to identify the interlimb and between-group differences in peak support moments and subsequent peak ankle, knee, and hip JMCs between individuals with an ACLR and matched controls during different sloped running conditions. A total of 17 individuals with unilateral ACLR and 17 healthy individuals who were matched based on sex, height, and mass participated in this study. The participants ran on an instrumented treadmill at an incline of 4°, decline of 4°, incline of 10°, and decline of 10°. The last 10 strides of each condition were used to compare the whole-stance phase support moments and JMCs between limbs, ACLR, and control groups and across conditions. No differences in JMCs were identified between limbs or between the ACLR and healthy control groups across all conditions. Support moments did not change among the different sloped conditions, but JMCs significantly changed. Specifically, ankle and knee JMCs decreased and increased by 30% and 33% from an incline of 10° to a decline of 10° running. Here, the lower extremities can redistribute mechanics across the ankle, knee, and hip while maintaining consistent support moments during incline and decline running. Our data provide evidence that those with an ACLR do not exhibit significant alterations in joint contributions while running on sloped conditions compared to the matched controls. Our findings inform future research interested in understanding the relationship between sloped running mechanics and the incidence of deleterious acute or chronic problems in people with an ACLR., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Harrison, Holmes, Finley, Guzman, Kimbrough and Roper.)

Background: Observational data have been conflicted regarding the potential role of HIV antiretroviral therapy (ART) as a causative factor for, or protective factor against, COPD. We therefore aimed to investigate the effect of immediate versus deferred ART on decline in lung function in HIV-positive individuals., Methods: We did a nested substudy within the randomised, controlled Strategic Timing of Antiretroviral Treatment (START) trial at 80 sites in multiple settings in 20 high-income and low-to-middle-income countries. Participants were HIV-1 infected individuals aged at least 25 years, naive to ART, with CD4 T-cell counts of more than 500 per μL, not receiving treatment for asthma, and without recent respiratory infections (baseline COPD was not an exclusion criterion). Participants were randomly assigned to receive ART (an approved drug combination derived from US Department of Health and Human Services guidelines) either immediately, or deferred until CD4 T-cell counts decreased to 350 per μL or AIDS developed. The randomisation was determined by participation in the parent START study, and was not specific to the substudy. Because of the nature of our study, site investigators and participants were not masked to the treatment group assignment; however, the assessors who reviewed the outcomes were masked to the treatment group. The primary outcome was the annual rate of decline in lung function, expressed as the FEV 1 slope in mL/year; spirometry was done annually during follow-up for up to 5 years. We analysed data on an intention-to-treat basis, and planned separate analyses in smokers and non-smokers because of the known effects of smoking on FEV 1 decline. The substudy was registered at ClinicalTrials.gov number NCT01797367., Findings: Between March 11, 2010, and Aug 23, 2013, we enrolled 1026 participants to our substudy, who were then randomly assigned to either immediate (n=518) or deferred (n=508) ART. Median baseline characteristics included age 36 years (IQR 30-44), CD4 T-cell count 648 per μL (583-767), and HIV plasma viral load 4·2 log 10 copies per mL (3·5-4·7). 29% were female and 28% were current smokers. Median follow-up time was 2·0 years (IQR 1·9-3·0). We noted no differences in FEV 1 slopes between the immediate and deferred ART groups either in smokers (difference of -3·3 mL/year, 95% CI -38·8 to 32·2; p=0·86) or in non-smokers (difference of -5·6 mL/year, -29·4 to 18·3; p=0·65) or in pooled analyses adjusted for smoking status at each study visit (difference of -5·2 mL/year, -25·1 to 14·6; p=0·61)., Interpretation: The timing of ART initiation has no major short-term effect on rate of lung function decline in HIV-positive individuals who are naive to ART, with CD4 T-cell counts of more than 500 per μL. In light of updated WHO recommendations that all HIV-positive individuals should be treated with ART, regardless of their CD4 T-cell count, our results suggest an absence of significant pulmonary harm with such an approach., Funding: US National Heart Lung and Blood Institute, US National Institute of Allergy and Infectious Diseases, Division of AIDS, Agence Nationale de Recherches sur le SIDA et les Hipatites Virales (France), Australian National Health and Medical Research Council, Danish National Research Foundation, European AIDS Treatment Network, German Ministry of Education and Research, UK Medical Research Council and National Institute for Health Research, and US Veterans Health Administration Office of Research and Development., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Background: Trial monitoring protects participant safety and study integrity. While monitors commonly go on-site to verify source data, there is little evidence that this practice is efficient or effective. An ongoing international HIV treatment trial (START) provides an opportunity to explore the usefulness of different monitoring approaches., Methods: All START sites are centrally monitored and required to follow a local monitoring plan requiring specific quality assurance activities. Additionally, sites were randomized (1:1) to receive, or not receive, annual on-site monitoring. The study will determine if on-site monitoring increases the identification of major protocol deviations (eligibility or consent violations, improper study drug use, primary or serious event underreporting, data alteration or fraud)., Results: The START study completed enrollment in December 2013, with planned follow-up through December 2016. The monitoring study is ongoing at 196 sites in 34 countries. Results are expected when the START study concludes in December 2016.