Faculty Opinions recommendation of Effect of Algorithm-Based Therapy vs Usual Care on Clinical Success and Serious Adverse Events in Patients with Staphylococcal Bacteremia: A Randomized Clinical Trial.

Author(s):  
Joseph John Jr
2020 ◽  
Vol 75 (6) ◽  
pp. 1618-1622
Author(s):  
François Raffi ◽  
Aurélie Gaultier ◽  
Anton Pozniak ◽  
Jean-Michel Molina ◽  
Heiko Jessen ◽  
...  

Abstract Background Few long-term data are available in subjects having initiated ART with an NRTI-sparing regimen. Objectives Outcomes of subjects enrolled in the NEAT 001/ANRS 143 randomized clinical trial (comparing ritonavir-boosted darunavir + raltegravir versus ritonavir-boosted darunavir + tenofovir disoproxil fumarate/emtricitabine) were retrospectively collected, through anonymized electronic case report forms, up to 6 years post-enrolment. Methods The last NEAT 001 visit (Week 96) was conducted in 745/805 randomized subjects (363/401 ritonavir-boosted darunavir + raltegravir and 382/404 ritonavir-boosted darunavir + tenofovir disoproxil fumarate/emtricitabine). Of these, 430 were enrolled in NEAT 001/ANRS 143 LONG TERM (NLT) study (201 raltegravir, 229 tenofovir disoproxil fumarate/emtricitabine), with a median follow-up of 44.4 months. Results During NLT follow-up, the proportion of AIDS, non-AIDS events, virological rebound and serious adverse events, discontinuation for virological failure and for adverse events did not differ between groups; discontinuations for virological failure since NEAT 001 inclusion were more frequent in subjects with baseline CD4 <200 cells/mm3 (11.9% versus 5.3%; P = 0.077). At last follow-up, a quarter of subjects (22.2% for ritonavir-boosted darunavir + raltegravir and 29.7% for ritonavir-boosted darunavir + tenofovir disoproxil fumarate/emtricitabine) were still receiving their initial regimen. Integrase inhibitor exposure was not associated with weight gain (P = 0.48), while tenofovir disoproxil fumarate exposure was associated with a trend to higher creatinine increase (P = 0.067). Conclusions After a median of 5.6 years, subjects initiating ritonavir-boosted darunavir + raltegravir or ritonavir-boosted darunavir + tenofovir disoproxil fumarate/emtricitabine experienced few serious clinical adverse events. Most discontinuations were for reasons unrelated to adverse events or virological failure.


JAMA ◽  
2018 ◽  
Vol 320 (12) ◽  
pp. 1249 ◽  
Author(s):  
Thomas L. Holland ◽  
Issam Raad ◽  
Helen W. Boucher ◽  
Deverick J. Anderson ◽  
Sara E. Cosgrove ◽  
...  

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Federico Longhini ◽  
Laura Pasin ◽  
Claudia Montagnini ◽  
Petra Konrad ◽  
Andrea Bruni ◽  
...  

Abstract Background Post-operative pulmonary complications (PPC) can develop in up to 13% of patients undergoing neurosurgical procedures and may adversely affect clinical outcome. The use of intraoperative lung protective ventilation (LPV) strategies, usually including the use of a low Vt, low PEEP and low plateau pressure, seem to reduce the risk of PPC and are strongly recommended in almost all surgical procedures. Nonetheless, feasibility of LPV strategies in neurosurgical patients are still debated because the use of low Vt during LPV might result in hypercapnia with detrimental effects on cerebrovascular physiology. Aim of our study was to determine whether LPV strategies would be feasible compared with a control group in adult patients undergoing cranial or spinal surgery. Methods This single-centre, pilot randomized clinical trial was conducted at the University Hospital “Maggiore della Carità” (Novara, Italy). Adult patients undergoing major cerebral or spinal neurosurgical interventions with risk index for pulmonary post-operative complications > 2 and not expected to need post-operative intensive care unit (ICU) admission were considered eligible. Patients were randomly assigned to either LPV (Vt = 6 ml/kg of ideal body weight (IBW), respiratory rate initially set at 16 breaths/min, PEEP at 5 cmH2O and application of a recruitment manoeuvre (RM) immediately after intubation and at every disconnection from the ventilator) or control treatment (Vt = 10 ml/kg of IBW, respiratory rate initially set at 6–8 breaths/min, no PEEP and no RM). Primary outcomes of the study were intraoperative adverse events, the level of cerebral tension at dura opening and the intraoperative control of PaCO2. Secondary outcomes were the rate of pulmonary and extrapulmonary complications, the number of unplanned ICU admissions, ICU and hospital lengths of stay and mortality. Results A total of 60 patients, 30 for each group, were randomized. During brain surgery, the number of episodes of intraoperative hypercapnia and grade of cerebral tension were similar between patients randomized to receive control or LPV strategies. No difference in the rate of intraoperative adverse events was found between groups. The rate of postoperative pulmonary and extrapulmonary complications and major clinical outcomes were similar between groups. Conclusions LPV strategies in patients undergoing major neurosurgical intervention are feasible. Larger clinical trials are needed to assess their role in postoperative clinical outcome improvements. Trial registration registered on the Australian New Zealand Clinical Trial Registry (www.anzctr.org.au), registration number ACTRN12615000707561.


2018 ◽  
Vol 5 (6) ◽  
Author(s):  
H Keipp Talbot ◽  
Andrew J Dunning ◽  
Corwin A Robertson ◽  
Victoria A Landolfi ◽  
David P Greenberg ◽  
...  

Abstract Passive surveillance data had signaled the possibility of gastrointestinal adverse events occurring after the administration of high-dose inactivated influenza vaccine (IIV-HD). However, in a large, prospective randomized clinical trial, rates of serious gastrointestinal events were no greater among IIV-HD recipients than among those who received a standard-dose influenza vaccine.


2021 ◽  
Author(s):  
Maj Siercke ◽  
Sanne Pagh Moller ◽  
Lau Caspar Thygesen ◽  
Henrik Sillesen ◽  
Dorthe Overgaard

Aim: This study aimed to explore how qualitative data about rehabilitation for patients with intermittent claudication do provide an enhanced understanding of the quantitative experimental results. Background: The study was a randomized clinical trial comparing a rehabilitation intervention with usual care. A statistically significant difference between rehabilitation and usual care was found in walking distance, physical activity, quality of life and diet. The findings from the quantitative and qualitative analyses were analysed separately on their own tradition. In this study, mixed methods address whether the qualitative results could help explain the quantitative results and bring forward additional information. Design: Complex mixed-method intervention design with a convergent questionnaire variant. Methods: From April 2017- May 2019, patients diagnosed with intermittent claudication were included in a randomized clinical trial (N=118). In addition, qualitative interview informants from the intervention group were sampled from the quantitative study population for a survey (N=43) and focus group interviews (N=10). Interviews were conducted from April 2018-August 2019. Results: Integrated analyses identified how improvement in walking distance, physical activity, diet and quality of life was affected by team spirit, pedometer, education and fun exercise in a local setting. Quantitative and qualitative findings primarily confirmed and expanded each other; however, two discordant results were also evident. Conclusion: Our study adds empirical evidence regarding how a mixed-methods study can be used to obtain a more nuanced understanding of complex healthcare problems. The study provides new knowledge concerning how to set up a rehabilitation programme for patients with intermittent claudication.


2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S161-S161
Author(s):  
Benjamin Eckhardt ◽  
Yesenia Aponte-Meledez ◽  
Chunki Fung ◽  
Shashi Kapadia ◽  
La Davis ◽  
...  

Abstract Background To achieve hepatitis C elimination, treatment programs need to be developed to engage, treat, and cure people who are actively injecting drugs. Methods We present preliminary data from the first 65 participants in the Accessible Care intervention for engaging people who inject illicit drugs (PWID) in hepatitis C (HCV) care. The randomized clinical trial compares the effectiveness of Accessible Care (low-threshold care in a syringe service program located in New York City) with Usual Care (referral to existing services) in facilitating linkage, engagement, and retention in HCV care. Eligible participants were HCV RNA positive and had injected drugs in the past 90 days. We compared the percentage of participants in each arm linked to HCV care (defined as one visit with HCV treatment provider), and initiated direct-acting antiviral (DAA) treatment within 6 months of enrollment. Results Among the 65 participants, the mean age is 41.2 years; 28% are females; 73% homeless; 6% black, 51% Latina/o and 39% white. 82% of participants had injected drugs in the last 30 days, with an average of 13.2 injections/month (median 10). Nearly all participants had health insurance, 88% public insurance, 6% uninsured. Thirty-two participants were randomized to the Accessible Care arm. Within 6 months of enrollment 79% of the Accessible Care arm and 25% of the Usual Care arm had linked to HCV care, and 69% and 13% had been started on DAA therapy, respectively. Of the 26 participants in the Accessible Care arm started on DAA therapy, the median time from enrollment to treatment initiation was 87.5 days [range 22–180]. Conclusion Among HCV-infected PWID enrolled at a syringe service program, higher rates of linkage to care and treatment initiation were seen in the Accessible Care arm where stigma- and shame-free treatment was located within a community-based location. Disclosures All authors: No reported disclosures.


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