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Efficacy, safety, and applicability of outpatient treatment for diverticulitis.

ABSTRACT: Acute diverticulitis of the colon represents a significant burden for national health systems, in terms of direct and indirect costs. Although current guidelines recommend use of antibiotics for the outpatient treatment of acute uncomplicated diverticulitis, evidence for this is still lacking. Hence, significant effort is now being made to identify the appropriate therapeutic approach to treat and prevent relapses of diverticulitis. Outpatient treatment has been identified as a safe and effective therapeutic approach in up to 90% of patients with uncomplicated diverticulitis. It allows important costs saving to health systems without a negative influence on quality of life for patients with uncomplicated diverticulitis, and reduces health care costs by more than 60%.

SUBMITTER: Tursi A

PROVIDER: S-EPMC3976207 | biostudies-other | 2014

REPOSITORIES: biostudies-other

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Efficacy, safety, and applicability of outpatient treatment for diverticulitis.

Tursi Antonio A

Drug, healthcare and patient safety 20140331

Acute diverticulitis of the colon represents a significant burden for national health systems, in terms of direct and indirect costs. Although current guidelines recommend use of antibiotics for the outpatient treatment of acute uncomplicated diverticulitis, evidence for this is still lacking. Hence, significant effort is now being made to identify the appropriate therapeutic approach to treat and prevent relapses of diverticulitis. Outpatient treatment has been identified as a safe and effectiv ...[more]

PMID: 24729730

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Project description:BackgroundIdentification of therapies to prevent severe COVID-19 remains a priority. We sought to determine whether hydroxychloroquine treatment for outpatients with SARS-CoV-2 infection could prevent hospitalization, mechanical ventilation or death.MethodsThis randomized controlled trial was conducted in Alberta during the first wave of the COVID-19 pandemic without direct contact with participants. Community-dwelling individuals with confirmed SARS-CoV-2 infection (by reverse transcription polymerase chain reaction [RT-PCR] viral ribonucleic acid test) within the previous 4 days, and symptom onset within the previous 12 days, were randomly assigned to oral hydroxychloroquine or matching placebo for 5 days. Enrolment began Apr. 15, 2020. The primary outcome was the composite of hospitalization, invasive mechanical ventilation or death within 30 days. Secondary outcomes included symptom duration and disposition at 30 days. Safety outcomes, such as serious adverse events and mortality, were also ascertained. Outcomes were determined by telephone follow-up and administrative data.ResultsAmong 4919 individuals with a positive RT-PCR test, 148 (10.2% of a planned 1446 patients) were randomly assigned, 111 to hydroxychloroquine and 37 to placebo. Of the 148 participants, 24 (16.2%) did not start the study drug. Four participants in the hydroxychloroquine group met the primary outcome (4 hospitalizations, 0 mechanical ventilation, 4 survived to 30 days) and none in the placebo group. Hydroxychloroquine did not reduce symptom duration (hazard ratio 0.77, 95% confidence interval 0.49-1.21). Recruitment was paused on May 22, 2020, when a since-retracted publication raised concerns about the safety of hydroxychloroquine for hospitalized patients with COVID-19. Although we had not identified concerns in a safety review, enrolment was slower than expected among those eligible for the study, and cases within the community were decreasing. Recruitment goals were deemed to be unattainable and the trial was not resumed, resulting in a study underpowered to assess the effect of treatment with hydroxychloroquine and safety.InterpretationThere was no evidence that hydroxychloroquine reduced symptom duration or prevented severe outcomes among outpatients with proven COVID-19, but the early termination of our study meant that it was underpowered.Trial registrationClinicalTrials.gov, no. NCT04329611.

Project description:BACKGROUND:The results of the randomized, phase 3 ET743-SAR-3007 trial demonstrated that trabectedin had a significantly longer progression-free survival (PFS) compared with dacarbazine in patients with advanced leiomyosarcoma/liposarcoma after the failure of prior chemotherapy. Patients randomized to trabectedin received a 24-hour intravenous infusion either in an inpatient or outpatient setting. Herein, the authors reported the safety, efficacy, and patient-reported outcomes based on first infusion site of care. METHODS:Patients were randomized 2:1 to trabectedin (at a dose of 1.5 mg/m2 ) or dacarbazine (1 g/m2 over 20-120 minutes) with overall survival (OS) as the primary endpoint and PFS, time to disease progression, objective response rate, duration of response, safety, and patient-reported symptom scoring as secondary endpoints. The setting of the trabectedin infusion was based on institutional preference and categorized based on the setting of the first infusion. RESULTS:Of the 378 patients who were treated with trabectedin, 100 (27%) and 277 (73%), respectively, first received trabectedin in the inpatient and outpatient setting. No differences were observed with regard to PFS or OS based on site of care. The median PFS was 4.1 months versus 4.2 months (hazard ratio, 0.90; P = .49) for inpatients versus outpatients, respectively, and the median OS was 14.3 months versus 13.7 months (hazard ratio, 0.89; P = .40), respectively. Grade 3/4 adverse events (classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.0]) were reported in 87 inpatients (87%) compared with 219 outpatients (79%); grade 3/4 serious adverse events were reported in 43 inpatients (43%) and 92 outpatients (33%). Extravasation occurred in 0 inpatients and 5 outpatients (2%), whereas the incidence of catheter-related complications was similar between groups (16% vs 15%). CONCLUSIONS:Although the majority of patients who were randomized to trabectedin received outpatient therapy, the outcomes of the current study suggested equivalent safety and efficacy in either setting.

Dataset Information

Efficacy, safety, and applicability of outpatient treatment for diverticulitis.

Publications

Efficacy, safety, and applicability of outpatient treatment for diverticulitis.

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