Evidence Based Practice Research Program

Rochester, MN, United States

Evidence Based Practice Research Program

Rochester, MN, United States
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Lok A.S.F.,University of Michigan | Mcmahon B.J.,Alaska Native Tribal Health Consortium | Brown R.S.,New York Medical College | Wong J.B.,Tufts Medical Center | And 22 more authors.
Hepatology | Year: 2016

Chronic hepatitis B viral (HBV) infection remains a significant global health problem. Evidence-based guidelines are needed to help providers determine when treatment should be initiated, which medication is most appropriate, and when treatment can safely be stopped. The American Association for the Study of Liver Diseases HBV guideline methodology and writing committees developed a protocol a priori for this systematic review. We searched multiple databases for randomized controlled trials and controlled observational studies that enrolled adults ≥18 years old diagnosed with chronic HBV infection who received antiviral therapy. Data extraction was done by pairs of independent reviewers. We included 73 studies, of which 59 (15 randomized controlled trials and 44 observational studies) reported clinical outcomes. Moderate-quality evidence supported the effectiveness of antiviral therapy in patients with immune active chronic HBV infection in reducing the risk of cirrhosis, decompensated liver disease, and hepatocellular carcinoma. In immune tolerant patients, moderate-quality evidence supports improved intermediate outcomes with antiviral therapy. Only very low-quality evidence informed the questions about discontinuing versus continuing antiviral therapy in hepatitis B e antigen-positive patients who seroconverted from hepatitis B e antigen to hepatitis B e antibody and about the safety of entecavir versus tenofovir. Noncomparative and indirect evidence was available for questions about stopping versus continuing antiviral therapy in hepatitis B e antigen-negative patients, monotherapy versus adding a second agent in patients with persistent viremia during treatment, and the effectiveness of antivirals in compensated cirrhosis with low-level viremia. Conclusion: Most of the current literature focuses on the immune active phases of chronic HBV infection; decision-making in other commonly encountered and challenging clinical settings depends on indirect evidence. © 2016 by the American Association for the Study of Liver Diseases.


Jonas M.M.,Boston Childrens Hospital | Lok A.S.F.,University of Michigan | Mcmahon B.J.,Alaska Native Tribal Health Consortium | Brown R.S.,New York Medical College | And 13 more authors.
Hepatology | Year: 2016

Most individuals with chronic hepatitis B viral (HBV) infection acquired the infection around the time of birth or during early childhood. We aimed to synthesize evidence regarding the effectiveness of antiviral therapy in the management of chronic HBV infection in children. We conducted a comprehensive search of multiple databases from 1988 to December 2, 2014, for studies that enrolled children (<18 years) with chronic HBV infection treated with antiviral therapy. We included observational studies and randomized controlled trials (RCTs). Two independent reviewers selected studies and extracted data. In the 14 included studies, two cohort studies showed no significant reduction in the already low risk of hepatocellular carcinoma or cirrhosis and 12 RCTs reported intermediate outcomes. In RCTs with posttreatment follow-up <12 months, antiviral therapy compared to placebo improved alanine aminotransferase normalization (risk ratio [RR] = 2.3, 95% confidence interval [CI] 1.7-3.2), hepatitis B e antigen (HBeAg) clearance/loss (RR = 2.1, 95% CI 1.5-3.1), HBV DNA suppression (RR = 2.9, 95% CI 1.8-4.6), HBeAg seroconversion (RR = 2.1, 95% CI 1.4-3.3), and hepatitis B surface antigen clearance (RR = 5.8, 95% CI 1.1-31.5). In RCTs with posttreatment follow-up ≥12 months, antiviral therapy improved cumulative HBeAg clearance/loss (RR = 1.9, 95% CI 1.7-3.1), HBeAg seroconversion (RR = 2.1, 95% CI 1.3-3.5), alanine aminotransferase normalization (RR = 1.4, 95% CI 1.1-1.7), and HBV DNA suppression (RR = 1.4, 95% CI 1.1-1.8) but not hepatitis B surface antigen clearance or seroconversion. Conclusion: In children with chronic HBV infection, antivirals compared to no antiviral therapy improve HBV DNA suppression and frequency of alanine aminotransferase normalization and HBeAg seroconversion. © 2016 by the American Association for the Study of Liver Diseases.


Brown R.S.,New York Medical College | Mcmahon B.J.,Alaska Native Tribal Health Consortium | Lok A.S.F.,University of Michigan | Wong J.B.,Tufts Medical Center | And 11 more authors.
Hepatology | Year: 2016

Perinatal or mother-to-child transmission (MTCT) of hepatitis B virus (HBV) remains the major risk factor for chronic HBV infection worldwide. In addition to hepatitis B immune globulin and vaccination, oral antiviral therapies in highly viremic mothers can further decrease MTCT of HBV. We conducted a systematic review and meta-analysis to synthesize the evidence on the efficacy and maternal and fetal safety of antiviral therapy during pregnancy. A protocol was developed by the American Association for the Study of Liver Diseases guideline writing committee. We searched multiple databases for controlled studies that enrolled pregnant women with chronic HBV infection treated with antiviral therapy. Outcomes of interest were reduction of MTCT and adverse outcomes to mothers and newborns. Study selection and data extraction were done by pairs of independent reviewers. We included 26 studies that enrolled 3622 pregnant women. Antiviral therapy reduced MTCT, as defined by infant hepatitis B surface antigen seropositivity (risk ratio = 0.3, 95% confidence interval 0.2-0.4) or infant HBV DNA seropositivity (risk ratio = 0.3, 95% confidence interval 0.2-0.5) at 6-12 months. No significant differences were found in the congenital malformation rate, prematurity rate, and Apgar scores. Compared to control, lamivudine or telbivudine improved maternal HBV DNA suppression at delivery and during 4-8 weeks' postpartum follow-up. Tenofovir showed improvement in HBV DNA suppression at delivery. No significant differences were found in postpartum hemorrhage, cesarean section, and elevated creatinine kinase rates. Conclusions: Antiviral therapy improves HBV suppression and reduces MTCT in women with chronic HBV infection with high viral load compared to the use of hepatitis B immunoglobulin and vaccination alone; the use of telbivudine, lamivudine, and tenofovir appears to be safe in pregnancy with no increased adverse maternal or fetal outcome. © 2016 by the American Association for the Study of Liver Diseases.


PubMed | University of Michigan, Center for the Science of Health Care Delivery, Mayo Medical School, Tufts Medical Center and 3 more.
Type: Journal Article | Journal: Hepatology (Baltimore, Md.) | Year: 2015

Chronic hepatitis B viral (HBV) infection remains a significant global health problem. Evidence-based guidelines are needed to help providers determine when treatment should be initiated, which medication is most appropriate, and when treatment can safely be stopped. The American Association for the Study of Liver Diseases HBV guideline methodology and writing committees developed a protocol a priori for this systematic review. We searched multiple databases for randomized controlled trials and controlled observational studies that enrolled adults 18 years old diagnosed with chronic HBV infection who received antiviral therapy. Data extraction was done by pairs of independent reviewers. We included 73 studies, of which 59 (15 randomized controlled trials and 44 observational studies) reported clinical outcomes. Moderate-quality evidence supported the effectiveness of antiviral therapy in patients with immune active chronic HBV infection in reducing the risk of cirrhosis, decompensated liver disease, and hepatocellular carcinoma. In immune tolerant patients, moderate-quality evidence supports improved intermediate outcomes with antiviral therapy. Only very low-quality evidence informed the questions about discontinuing versus continuing antiviral therapy in hepatitis B e antigen-positive patients who seroconverted from hepatitis B e antigen to hepatitis B e antibody and about the safety of entecavir versus tenofovir. Noncomparative and indirect evidence was available for questions about stopping versus continuing antiviral therapy in hepatitis B e antigen-negative patients, monotherapy versus adding a second agent in patients with persistent viremia during treatment, and the effectiveness of antivirals in compensated cirrhosis with low-level viremia.Most of the current literature focuses on the immune active phases of chronic HBV infection; decision-making in other commonly encountered and challenging clinical settings depends on indirect evidence.


PubMed | University of Michigan, Mayo Medical School, Tufts Medical Center, Boston Childrens Hospital and 3 more.
Type: Journal Article | Journal: Hepatology (Baltimore, Md.) | Year: 2015

Most individuals with chronic hepatitis B viral (HBV) infection acquired the infection around the time of birth or during early childhood. We aimed to synthesize evidence regarding the effectiveness of antiviral therapy in the management of chronic HBV infection in children. We conducted a comprehensive search of multiple databases from 1988 to December 2, 2014, for studies that enrolled children (<18 years) with chronic HBV infection treated with antiviral therapy. We included observational studies and randomized controlled trials (RCTs). Two independent reviewers selected studies and extracted data. In the 14 included studies, two cohort studies showed no significant reduction in the already low risk of hepatocellular carcinoma or cirrhosis and 12 RCTs reported intermediate outcomes. In RCTs with posttreatment follow-up <12 months, antiviral therapy compared to placebo improved alanine aminotransferase normalization (risk ratio [RR] = 2.3, 95% confidence interval [CI] 1.7-3.2), hepatitis B e antigen (HBeAg) clearance/loss (RR = 2.1, 95% CI 1.5-3.1), HBV DNA suppression (RR = 2.9, 95% CI 1.8-4.6), HBeAg seroconversion (RR = 2.1, 95% CI 1.4-3.3), and hepatitis B surface antigen clearance (RR = 5.8, 95% CI 1.1-31.5). In RCTs with posttreatment follow-up 12 months, antiviral therapy improved cumulative HBeAg clearance/loss (RR = 1.9, 95% CI 1.7-3.1), HBeAg seroconversion (RR = 2.1, 95% CI 1.3-3.5), alanine aminotransferase normalization (RR = 1.4, 95% CI 1.1-1.7), and HBV DNA suppression (RR = 1.4, 95% CI 1.1-1.8) but not hepatitis B surface antigen clearance or seroconversion.In children with chronic HBV infection, antivirals compared to no antiviral therapy improve HBV DNA suppression and frequency of alanine aminotransferase normalization and HBeAg seroconversion.


PubMed | University of Michigan, Library Public Services., Tufts Medical Center, Alaska Native Tribal Health Consortium and 2 more.
Type: Journal Article | Journal: Hepatology (Baltimore, Md.) | Year: 2015

Perinatal or mother-to-child transmission (MTCT) of hepatitis B virus (HBV) remains the major risk factor for chronic HBV infection worldwide. In addition to hepatitis B immune globulin and vaccination, oral antiviral therapies in highly viremic mothers can further decrease MTCT of HBV. We conducted a systematic review and meta-analysis to synthesize the evidence on the efficacy and maternal and fetal safety of antiviral therapy during pregnancy. A protocol was developed by the American Association for the Study of Liver Diseases guideline writing committee. We searched multiple databases for controlled studies that enrolled pregnant women with chronic HBV infection treated with antiviral therapy. Outcomes of interest were reduction of MTCT and adverse outcomes to mothers and newborns. Study selection and data extraction were done by pairs of independent reviewers. We included 26 studies that enrolled 3622 pregnant women. Antiviral therapy reduced MTCT, as defined by infant hepatitis B surface antigen seropositivity (risk ratio = 0.3, 95% confidence interval 0.2-0.4) or infant HBV DNA seropositivity (risk ratio = 0.3, 95% confidence interval 0.2-0.5) at 6-12 months. No significant differences were found in the congenital malformation rate, prematurity rate, and Apgar scores. Compared to control, lamivudine or telbivudine improved maternal HBV DNA suppression at delivery and during 4-8 weeks postpartum follow-up. Tenofovir showed improvement in HBV DNA suppression at delivery. No significant differences were found in postpartum hemorrhage, cesarean section, and elevated creatinine kinase rates.Antiviral therapy improves HBV suppression and reduces MTCT in women with chronic HBV infection with high viral load compared to the use of hepatitis B immunoglobulin and vaccination alone; the use of telbivudine, lamivudine, and tenofovir appears to be safe in pregnancy with no increased adverse maternal or fetal outcome.


Almasri J.,Evidence Based Practice Research Program | Alsawas M.,Evidence Based Practice Research Program | Mainou M.,Aristotle University of Thessaloniki | Mustafa R.A.,University of Missouri - Kansas City | And 5 more authors.
Journal of Vascular Surgery | Year: 2016

Background The decision about the type and location of a hemodialysis vascular access is challenging and can be affected by multiple factors. We explored the effect of several a priori chosen patient characteristics on access outcomes. Methods We searched MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Scopus through November 13, 2014. We included studies that evaluated patency, mortality, access infection, and maturation of vascular access in adults requiring long-term dialysis. Pairs of reviewers working independently selected the studies and extracted the data. Outcomes were pooled across studies using the random-effects model. Results Two hundred studies met the eligibility criteria reporting on 875,269 vascular accesses. Overall, studies appeared to have provided incidence rates at low to moderate risk of bias. The overall primary patency at 2 years was higher for fistulas than for grafts and catheters (55%, 40%, and 50%, respectively). Patency was lower in individuals with diabetes, coronary artery disease, older individuals, and in women. Mortality at 2 years was highest with catheters, followed by grafts then fistulas (26%, 17%, and 15%, respectively). Conclusions The current evidence remains in support of autogenous access as the best approach when feasible. We provide incidence rates in various subgroups to inform shared decision making and facilitate the conversation with patients about access planning. © Copyright 2016 by the Society for Vascular Surgery. Published by Elsevier Inc.


PubMed | Mayo Medical School, Evidence Based Practice Research Program and Oakland University
Type: Journal Article | Journal: Cardiovascular and interventional radiology | Year: 2016

Subclavian artery occlusive disease (SAOD) is often associated with cerebrovascular symptoms such as subclavian steal syndrome and stroke. We conducted a systematic review and meta-analysis to compare percutaneous transluminal angioplasty (PTA) and stent placement for the treatment of SAOD.We searched Medline, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Scopus through October 16, 2014. From each study, we abstracted baseline patient characteristics, study design variables, and outcome data including rates of technical success, primary patency (2 and >2 years follow-up), symptom resolution, and complications. Meta-analysis was performed using a random-effects model.A total of 35 non-comparative studies with 1726 patients were included. Technical success rate was significantly higher in the stent group than the PTA group (92.8 vs 86.8%, p = 0.007). Long-term primary patency rates (76.9 vs 79.6%, p = 0.729) and symptom resolution rates (82.2 vs 73.0%, p = 0.327) were not statistically different. There was no statistically significant difference in the rates of stroke or death.Stent placement for treatment of SAOD may be associated with higher rates of technical success but similar rates of symptom resolution and long-term outcomes. The confidence in the available estimates is low. Further comparative studies are needed to guide patients and clinicians in shared decision making.


Benkhadra K.,Evidence Based Practice Research Program | Benkhadra K.,Mayo Clinic Robert d Patricia rn Center For The Science Of Health Care Delivery | Adusumalli J.,Evidence Based Practice Research Program | Rajjo T.,Evidence Based Practice Research Program | And 5 more authors.
BMC Health Services Research | Year: 2016

Background: The healthcare needs of physician are not well studied. Methods: We surveyed physicians attending a large primary care conference about their access and perceived barriers to receiving healthcare services. Results: Response rate was 46 % (270/592). The majority were trained in family medicine. The age category of above 60 years was the most common (39 %) and 46 % were women. Important difficulty in accessing healthcare services was reported by 39 % of physicians and the majority (61 %) reported reverting to self-diagnosis and self-treatment. Female physicians reported more difficulties than male physicians (p < 0.001 for difficulty in securing access and p = 0.02 for self-diagnosis and treatment). The barriers cited were finding time for healthcare, concern about confidentiality, and lack of encouragement by employer. Respondents reported experiencing a career threatening illness themselves (20 %) or in a colleague (81 %). Forty-two percent experienced being concerned about a colleague being able to safely practice due to illness. Participants ranked substance abuse as the most common illnesses affecting a physician's ability to practice followed by psychiatric disorders, heart disease, neurological disorders and cancer. Conclusions: Physicians face important barriers to accessing healthcare services. Female physicians report worse access. The identified barriers are modifiable. This survey calls for efforts to improve physicians' health that require collaboration among physicians, employers and policymakers. © 2016 The Author(s).


Al Nofal A.,Mayo Medical School | Al Nofal A.,Evidence Based Practice Research Program | Lteif A.,Mayo Medical School
Journal of Pediatrics | Year: 2015

Objective To report our experience in treating infants and toddlers with central diabetes insipidus (DI) with thiazide diuretics. Study design A retrospective chart review of all infants and toddlers who were treated with thiazide diuretics for central DI at the Mayo Clinic between 1996 and 2014. Results Our cohort consisted of 13 patients. The median age at the start of therapy was 6 months (IQR, 1-14 months). Eight patients were given chlorothiazide at a starting dose of 5-10 mg/kg/day, and 5 patients were treated with hydrochlorothiazide at a starting dose of 1-2 mg/kg/day. The median age at the cessation of thiazide therapy was 18 months (IQR, 11.5-39 months). The main reason for stopping was the lack of continued response, in addition to hypernatremia. There was no hospitalization secondary to hyponatremia and only 1 hospitalization secondary to hypernatremia while receiving thiazide therapy. Calcium was checked periodically in 7 of the 13 patients, and 2 of these 7 patients had persistent hypercalcemia. Conclusion Thiazide diuretics appear to be safe and effective in treating infants with central DI. They can be continued after the introduction of solid food, and until a lack of response is observed. © 2015 Elsevier Inc.

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