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1.
PLoS One ; 18(5): e0283226, 2023.
Article in English | MEDLINE | ID: mdl-37126507

ABSTRACT

BACKGROUND: Older patients often arrive in acute care wards with inappropriate footwear. Hospitals may provide non-slip socks to improve the patients' safety. However, few studies have been conducted on the benefits of non-slip socks. A recent literature review found only two randomized controlled studies that evaluated non-slip socks, but the socks were not the primary focus of the studies. The aim of this study is therefore to specifically evaluate the benefits of non-slip socks on gait in hospitalized older people. METHODS: This open, randomized, controlled trial will include patients aged 75 years and over, hospitalized in an acute medical unit. Patients will be randomized to either remain barefoot or wear non-slip socks throughout their stay. The primary outcome is gait speed, assessed on Day 1 and Day 8. DISCUSSION: This randomized controlled trial should provide clinicians with a scientific rational for the recommendation, or not, of the use of non-slip socks for older patients in acute care hospitals. TRIAL REGISTRATION: https://clinicaltrials.gov/ on May 12, 2021 under the reference: NCT04882696 https://clinicaltrials.gov/ct2/show/NCT04882696.


Subject(s)
Gait , Hospitals , Aged , Humans , Walking Speed , Critical Care , Patient Safety , Randomized Controlled Trials as Topic
2.
NEJM Evid ; 2(8): EVIDoa2200332, 2023 Aug.
Article in English | MEDLINE | ID: mdl-38320142

ABSTRACT

BACKGROUND: Admission to the hospital is a major risk factor for the development of venous thromboembolism (VTE). Whether thromboprophylaxis with low-molecular-weight heparin prevents symptomatic VTE in medically ill, hospitalized older adults remains debated. METHODS: In a prospective, randomized, placebo-controlled, double-blind, multicenter trial, older adults (>70 years of age) hospitalized for acute medical conditions were randomly assigned to receive 40 mg a day of low-molecular-weight heparin (enoxaparin) or placebo for 6 to 14 days. The primary efficacy outcome was the cumulative incidence of symptomatic VTE (distal or proximal deep vein thrombosis, fatal or nonfatal pulmonary embolism) at 30 days. The primary safety outcome was major bleeding. Secondary outcomes included efficacy and safety outcomes at 90 days. RESULTS: The trial was prematurely discontinued in September 2020, 5 years after enrollment began, because of drug supply issues. By the time of trial discontinuation, 2559 patients had been randomly assigned at 47 centers. Median age was 82 years and 60% of patients were female. In the intention-to-treat population, the primary efficacy outcome occurred in 22 out of 1278 (cumulative incidence, 1.8%) patients in the enoxaparin group and in 27 out of 1263 (cumulative incidence, 2.2%) patients in the placebo group (cumulative incidence difference, −0.4 percentage points; 95% confidence interval, −1.5 to 0.7), with no significant difference in time to VTE (P=0.46). The incidence of major bleeding was 0.9% in the enoxaparin group and 1.0% in the placebo group. At 90 days there were 14 symptomatic pulmonary emboli in the enoxaparin group and 25 in the placebo group; all 39 pulmonary embolism events resulted in hospital readmission and/or death, with 5 deaths from pulmonary embolism in the enoxaparin group and 11 deaths in the placebo group. CONCLUSIONS: This trial of thromboprophylaxis in medically ill, hospitalized older adults did not demonstrate that enoxaparin reduced the risk of symptomatic VTE after 1 month. Because the trial was prematurely discontinued, larger trials are needed to definitively address this question. (Funded by the French Ministry of Health Programme Hospitalier de Recherche Clinique, grant number PHRC-N-13-0283; ClinicalTrials.gov number, NCT02379806.)


Subject(s)
Enoxaparin , Venous Thromboembolism , Aged , Humans , Anticoagulants , Patients , Venous Thromboembolism/drug therapy
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