Dataset Information

Electronic Medical Alerts Increase Screening for Chronic Hepatitis B: A Randomized, Double-Blind, Controlled Trial.

ABSTRACT: Background: Implementation of screening recommendations for chronic hepatitis B (CHB) among foreign-born persons at risk has been sub-optimal. The use of alerts and reminders in the electronic health record (EHR) has led to increased screening for other common conditions. The aim of our study was to measure the effectiveness of an EHR alert on the implementation of hepatitis B surface antigen (HBsAg) screening of foreign-born Asian and Pacific Islander (API) patients.Methods: We used a novel technique to identify API patients by self-identified ethnicity, surname, country of origin, and language preference, and who had no record of CHB screening with HBsAg within the EHR. Patients with Medicare and/or Medicaid insurance were excluded due to lack of coverage for routine HBsAg screening at the time of this study. At-risk API patients were randomized to alert activation in their EHR or not (control).Results: A total of 2,987 patients met inclusion criteria and were randomized to the alert (n = 1,484) or control group (n = 1,503). In the alert group, 119 patients were tested for HBsAg, compared with 48 in the control group (odds ratio, 2.64; 95% confidence interval, 1.88-3.73; P < 0.001). In the alert group, 4 of 119 (3.4%) tested HBsAg-positive compared with 5 of 48 (10.4%) in the control group (P = 0.12).Conclusions: An EHR alert significantly increased HBsAg testing among foreign-born APIs.Impact: Utilization of EHR alerts has the potential to improve implementation of hepatitis B-screening guidelines. Cancer Epidemiol Biomarkers Prev; 27(11); 1352-7. ©2018 AACR.

SUBMITTER: Chak E

PROVIDER: S-EPMC6214733 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Electronic Medical Alerts Increase Screening for Chronic Hepatitis B: A Randomized, Double-Blind, Controlled Trial.

Chak Eric E Taefi Amir A Li Chin-Shang CS Chen Moon S MS Harris Aaron M AM MacDonald Scott S Bowlus Christopher C

Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology 20180808 11

<b>Background:</b> Implementation of screening recommendations for chronic hepatitis B (CHB) among foreign-born persons at risk has been sub-optimal. The use of alerts and reminders in the electronic health record (EHR) has led to increased screening for other common conditions. The aim of our study was to measure the effectiveness of an EHR alert on the implementation of hepatitis B surface antigen (HBsAg) screening of foreign-born Asian and Pacific Islander (API) patients.<b>Methods:</b> We us ...[more]

PMID: 30089680

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Project description:BACKGROUND:Acute kidney injury often goes unrecognised in its early stages when effective treatment options might be available. We aimed to determine whether an automated electronic alert for acute kidney injury would reduce the severity of such injury and improve clinical outcomes in patients in hospital. METHODS:In this investigator-masked, parallel-group, randomised controlled trial, patients were recruited from the hospital of the University of Pennsylvania in Philadelphia, PA, USA. Eligible participants were adults aged 18 years or older who were in hospital with stage 1 or greater acute kidney injury as defined by Kidney Disease Improving Global Outcomes creatinine-based criteria. Exclusion criteria were initial hospital creatinine 4·0 mg/dL (to convert to ?mol/L, multiply by 88·4) or greater, fewer than two creatinine values measured, inability to determine the covering provider, admission to hospice or the observation unit, previous randomisation, or end-stage renal disease. Patients were randomly assigned (1:1) via a computer-generated sequence to receive an acute kidney injury alert (a text-based alert sent to the covering provider and unit pharmacist indicating new acute kidney injury) or usual care, stratified by medical versus surgical admission and intensive care unit versus non-intensive care unit location in blocks of 4-8 participants. The primary outcome was a composite of relative maximum change in creatinine, dialysis, and death at 7 days after randomisation. All analyses were by intention to treat. This study is registered with ClinicalTrials.gov, number NCT01862419. FINDINGS:Between Sept 17, 2013, and April 14, 2014, 23,664 patients were screened. 1201 eligible participants were assigned to the acute kidney injury alert group and 1192 were assigned to the usual care group. Composite relative maximum change in creatinine, dialysis, and death at 7 days did not differ between the alert group and the usual care group (p=0·88), or within any of the four randomisation strata (all p>0·05). At 7 days after randomisation, median maximum relative change in creatinine concentrations was 0·0% (IQR 0·0-18·4) in the alert group and 0·6% (0·0-17·5) in the usual care group (p=0·81); 87 (7·2%) patients in the alert group and 70 (5·9%) patients in usual care group had received dialysis (odds ratio 1·25 [95% CI 0·90-1·74]; p=0·18); and 71 (5·9%) patients in the alert group and 61 (5·1%) patients in the usual care group had died (1·16 [0·81-1·68]; p=0·40). INTERPRETATION:An electronic alert system for acute kidney injury did not improve clinical outcomes among patients in hospital. FUNDING:Penn Center for Healthcare Improvement and Patient Safety.

Project description:ObjectiveTo evaluate the efficacy and safety of galcanezumab, a humanized monoclonal antibody that selectively binds to calcitonin gene-related peptide, in the preventive treatment of chronic migraine.MethodsA phase 3, randomized, double-blind, placebo-controlled study of LY2951742 in patients with chronic migraine (Evaluation of Galcanezumab in the Prevention of Chronic Migraine [REGAIN]) was a phase 3 study with a 3-month double-blind, placebo-controlled treatment phase and a 9-month open-label extension. Eligible patients 18 to 65 years of age with chronic migraine were randomized 2:1:1 to monthly subcutaneous injections of placebo (n = 558), galcanezumab 120 mg (with a 240-mg loading dose, n = 278), or galcanezumab 240 mg (n = 277). The primary endpoint was the overall mean change from baseline in the number of monthly migraine headache days (MHDs) during the 3-month double-blind treatment phase.ResultsMean number of monthly MHDs at baseline was 19.4 for the total sample. Both galcanezumab dose groups demonstrated greater overall mean reduction in the number of monthly MHDs compared to placebo (placebo -2.7, galcanezumab 120 mg -4.8, galcanezumab 240 mg -4.6) (p < 0.001 for each dose compared to placebo). There were no clinically meaningful differences between galcanezumab doses and placebo on any safety or tolerability outcome except for a higher incidence of treatment-emergent injection-site reaction (p < 0.01), injection-site erythema (p < 0.001), injection-site pruritus (p < 0.01), and sinusitis (p < 0.05) in the galcanezumab 240-mg group relative to placebo.ConclusionsBoth doses of galcanezumab were superior to placebo in reducing the number of monthly MHDs. Galcanezumab appears efficacious, safe, and well tolerated for the preventive treatment of chronic migraine.Clinicaltrialsgov identifierNCT02614261.Classification of evidenceThis interventional study provides Class I evidence that galcanezumab is superior to placebo in the reduction of the number of monthly MHDs.

Project description:BACKGROUND:Therapies for chronic hepatitis delta virus (HDV) infection are unsatisfactory. Prenylation is essential for HDV and inhibition abrogates HDV production in experimental models. In a proof-of-concept study, we aimed to assess the effect on HDV RNA levels, safety, and tolerability of the prenylation inhibitor lonafarnib in patients with chronic delta hepatitis. METHODS:In this phase 2A double-blind, randomised, placebo-controlled study, patients aged 18 years or older with chronic HDV infection were randomly assigned (3:1 in group 1 and 2:1 in group 2) to receive lonafarnib 100 mg (group 1) or lonafarnib 200 mg (group 2) twice daily for 28 days with 6 months' follow-up. Participants were randomised by random-number tables blocked in groups of four without stratification. Both groups enrolled six treatment participants and two placebo participants. Group 1 placebo patients received open-label lonafarnib as group 2 participants. The primary therapeutic endpoint was a decrease in HDV RNA viral titre in serum and the primary safety endpoint was the ability to tolerate the drug at the prescribed dose for the full 4-week duration, defined as drug discontinuation due to intolerance or grade 3/4 adverse events. This trial is registered with ClinicalTrials.gov, number NCT01495585. FINDINGS:Between Jan 19, 2012, and April 28, 2014, 14 patients were enrolled, of whom eight were assigned to group 1 and six were assigned to group 2. At day 28, compared with placebo, mean log HDV RNA declines from baseline were -0·73 log IU/mL in group 1 (95% CI 0·17-1·31; p=0·03) and -1·54 log IU/mL in group 2 (1·21-1·93; p<0·0001). Lonafarnib serum concentrations correlated with HDV RNA change (r(2)=0·78, p<0·0001). Model fits show that hepatitis B surface antigen (HBsAg) remained stable after a short pharmacological delay (0·75 days [SE 0·24]), lonafarnib effectiveness in blocking HDV production was greater in group 2 than in group 1 (0·952 [SE 0·06] vs 0·739 [0·05], p<0·001), and the HDV half-life was 1·62 days (0·07). There was no evidence of virological resistance. Adverse events were mainly mild to moderate with group 1 patients experiencing diarrhoea in three patients (50%) and nausea in two patients (33%) and in group 2 with all patients (100%) experiencing nausea, diarrhoea, abdominal bloating, and weight loss greater than 2 kg (mean of 4 kg). No treatment discontinuations occurred in any treatment groups. INTERPRETATION:Treatment of chronic HDV with lonafarnib significantly reduces virus levels. The decline in virus levels significantly correlated with serum drug levels, providing further evidence for the efficacy of prenylation inhibition in chronic HDV. FUNDING:National Institute of Diabetes and Digestive and Kidney Diseases and National Cancer Institute, National Institutes of Health, and Eiger Biopharmaceuticals Inc.

Dataset Information

Electronic Medical Alerts Increase Screening for Chronic Hepatitis B: A Randomized, Double-Blind, Controlled Trial.

Publications

Electronic Medical Alerts Increase Screening for Chronic Hepatitis B: A Randomized, Double-Blind, Controlled Trial.

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