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Completed Systematic Reviews




Screening for Hepatitis B Virus Infection in Nonpregnant Adolescents and Adults: A Systematic Review for the U.S. Preventive Services Task Force [Entered Retrospectively]


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Statistics: 52 Studies, 7 Key Questions, 1 Extraction Form,
Date Published: Dec 22, 2020 02:50PM
Description: Background: A 2014 review for the US Preventive Services Task Force (USPSTF) found antiviral therapy for hepatitis B virus (HBV) infection associated with improved intermediate outcomes, although evidence on clinical outcomes was limited. Purpose: To update the 2014 HBV screening review in nonpregnant adolescents and adults to inform the USPSTF. Data Sources: We utilized the 2014 review, searched the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, and Ovid MEDLINE (2014 to August 2019); with surveillance through July 24, 2020. Study Selection: Eligible studies included randomized controlled trials (RCTs) and cohort studies on the benefits and harms of screening versus no screening, and the yield of alternative screening strategies; RCTs on the effects of antiviral therapy versus placebo or no therapy and preferred versus nonpreferred therapies on intermediate outcomes, clinical outcomes, and harms; and cohort studies on clinical outcomes and on the association between intermediate outcomes following antiviral therapy and clinical outcomes. Data Extraction: One investigator abstracted data and a second investigator checked data abstraction for accuracy. Two investigators independently assessed study quality using methods developed by the USPSTF. Data Synthesis (Results): Fifty total studies (30 trials and 20 cohort studies) with a total of 94,168 participants were included; of these, 22 were added for this update. No study directly evaluated the effects of screening for HBV infection versus no screening on clinical outcomes, such as mortality, hepatocellular carcinoma, or cirrhosis. Screening strategies that focused on risk factors such as ever having immigrated from high prevalence countries plus demographic and behavioral risk factors would identify nearly all HBV infection cases. In one study (N=21,008), only screening immigrants from high HBV prevalence countries would miss approximately two-thirds of infected persons. Based on 18 trials (N=2,972), antiviral therapy was associated with greater likelihood than placebo or no treatment for achieving intermediate outcomes, such as virologic suppression and hepatitis B e antigen or hepatitis B surface antigen loss or seroconversion; the numbers needed to treat ranged from 2.6 for virological suppression to 17 for hepatitis B e antigen seroconversion. Based on 12 trials (N=4,127), preferred (first-line) antiviral therapies were at least as likely as nonpreferred therapies to achieve intermediate outcomes. Based on 16 trials (N=4,809), antiviral therapy might be associated with improved clinical outcomes, but data were sparse and imprecise. Nine cohort studies (N=3,893) indicated an association between achieving an intermediate outcome following antiviral therapy and improved clinical outcomes, but were heterogeneous (hazards ratios ranged from 0.07 to 0.87). Antiviral therapy was associated with higher risk of withdrawal due to adverse events versus placebo or no antiviral therapy. Limitations: Only English-language articles were included, clinical outcome data for antiviral therapies were limited, observational studies were included on effects of antiviral therapy on long-term clinical outcomes and the association between intermediate and clinical outcomes, and some studies were conducted in countries where the prevalence and natural history of HBV infection are different from the United States. Conclusions: There was no direct evidence for the clinical benefits and harms of HBV screening versus no screening. Antiviral therapy for HBV infection was associated with improved intermediate outcomes and may improve clinical outcomes. Research is needed to clarify effects of screening and subsequent interventions on clinical outcomes and to identify optimal screening strategies.
Contributor(s): Roger Chou, MD Ian Blazina, MPH Christina Bougatsos, MPH Rebecca Holmes, MD, MS Shelley Selph, MD, MPH Sara Grusing, BA Janice Jou, MD, MHS
DOI: DOI pending.
Funding Source: This report is based on research conducted by the Pacific Northwest Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. HHSA290201500009-I, Task Order No. 14)
Methodology Description: Data Sources: We utilized the 2014 review, searched the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, and Ovid MEDLINE (2014 to August 2019); with surveillance through July 24, 2020. Study Selection: Eligible studies included randomized controlled trials (RCTs) and cohort studies on the benefits and harms of screening versus no screening, and the yield of alternative screening strategies; RCTs on the effects of antiviral therapy versus placebo or no therapy and preferred versus nonpreferred therapies on intermediate outcomes, clinical outcomes, and harms; and cohort studies on clinical outcomes and on the association between intermediate outcomes following antiviral therapy and clinical outcomes. Data Extraction: One investigator abstracted data and a second investigator checked data abstraction for accuracy. Two investigators independently assessed study quality using methods developed by the USPSTF.

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Resource Allocation and Pandemic Response: An Evidence Synthesis to Inform Decision-Making


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Statistics: 201 Studies, 1 Key Question, 1 Extraction Form,
Date Published: Nov 19, 2020 09:20PM
Description: None Provided
Contributor(s): Susanne Hempel, Rita V. Burke, Michael Hochman, Gina Thompson, Annie Brothers, Jennifer Shin, Aneesa Motala, Jody Larkin, and Jeanne Ringel Creator: amotala (Aneesa Motala)
DOI: DOI pending.
Funding Source: Agency for Healthcare Research and Quality
Methodology Description: We searched the databases PubMed, Web of Science, and Cochrane Database of Systematic Reviews on May 4, 2020. The search strategy is documented in Appendix A (p. 33). We included empirical studies and simulations evvaluating strategies for policy makers as well as consensus guidelines to allocate scarce resources. Studies had to address the allocation of scarce resources and interventions had to be aimed at policy makers such as local public health officials rather than individual clinicians.

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Omega-3 Fatty Acids and Cardiovascular Disease: An Updated Systematic Review


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Statistics: 119 Studies, 2 Key Questions, 2 Extraction Forms,
Date Published: Nov 19, 2020 02:56PM
Description: The effect and association of omega−3 fatty acids (n-3 FA) intake and biomarker levels with cardiovascular (CV) clinical and intermediate outcomes remains controversial. We update prior Evidence Reports of n-3 FA and clinical and intermediate CV disease (CVD) outcomes.
Contributor(s): Ethan M. Balk, M.D., M.P.H. Gaelen P. Adam, M.L.I.S. Valerie Langberg, Sc.M. Christopher Halladay, B.A., Sc.M. Mei Chung, M.P.H., Ph.D. Lin Lin, M.A., Sc.M. Sarah Robertson, B.S. Agustin Yip, M.D. Dale Steele, M.D. Bryant T. Smith, M.P.H., C.P.H. Joseph Lau, M.D. Alice H. Lichtenstein, D.Sc. Thomas A. Trikalinos, M.D., Ph.D.
DOI: DOI pending.
Funding Source: AHRQ (Contract No. 290-2012-00012-I)
Methodology Description: We included randomized controlled trials (RCTs) of any n-3 FA intake compared to no, lower, or other n-3 FA intake with an outcome of interest conducted in healthy adults, those at risk for CVD, or those with CVD. We also included prospective observational studies of the association between baseline n-3 FA intake or biomarker level and followup outcomes. We required 1 year or more of followup for clinical outcomes and 4 weeks for intermediate outcomes (blood pressure [BP] and lipids).

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Management of Primary Headache During Pregnancy


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Statistics: 52 Studies, 4 Key Questions, 2 Extraction Forms,
Date Published: Nov 09, 2020 04:26PM
Description: This systematic review will assess the prevention and treatment of primary headache during pregnancy, postpartum, and breastfeeding.
Contributor(s): Brown University Evidence-based Practice Center
DOI: DOI pending.
Funding Source: Agency for Healthcare Research and Quality
Methodology Description: A full systematic review

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Three types of hypoglycemic agents (DPP- 4Is, GLP-1RAs, SGLT-2Is) for patients with type 2 diabetes: effectiveness and safety evaluation network meta-analysis


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Statistics: 9 Studies, 5 Key Questions, 1 Extraction Form,
Date Published: Oct 26, 2020 11:12AM
Description: Objective: In view of the development of hypoglycemic agents in recent years and the growth in the number of people with type 2 diabetes mellitus(T2DM), latest information is needed for clinicians and patients to make more reliable decisions. The objective of this systematic review database is to compare and summarize the effects of the current three new types of hypoglycemic agents: dipeptidyl peptidase-4 inhibitors (DPP-4Is), glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium-dependent glucose transporter 2 inhibition SGLT-2Is on outcomes of effectiveness, safety and economy. Methods: We searched the PubMed, Embase and Cochrane Library databases for original English-language articles, and collected unpublished studies’ data from clinicaltrial.org and other sources,we also manually search reference list of review literatures and grey literatures. We included all randomized controlled trials (RCTs) that any one of the three new types of hypoglycemic drugs (DPP-4Is, GLP-1RAs or SGLT-2Is) was applied in at least one comparative group in the RCT, alone or combined with other drugs. The searching process is now updated to March 2019, and will be updated every 1-2 years. Results: The numbers of RCTs we found completed and have reported outcomes were as follow: DPP-4Is 414, GLP-1RAs 338, SGLT-2Is 307. The total number of these literatures were 1059. After removing the duplicate literatures between the three types of hypoglycemic drugs, the total number of studies included in this systematic review database is now 930. The most common control group is placebo in this literature warehouse now. Other hypoglycemic drugs are also be compared as control, including: Biguanide, Sulfonylureas, Thiazolidinedione, Alpha-glucosidase inhibitor, insulin preparations, etc. Meanwhile, there are also comparisons between or within the three new types of hypoglycemic drugs. Significance: Till today, the existing results of original researches on the effectiveness and safety of three type of hypoglycemic drugs are diverse, and related systematic reviews are still incomplete. For example, study had shown that SGLT-2Is improve cardiovascular function in T2DM patients with coronary artery disease or chronic kidney dysfunction compared to DPP-4Is; DPP-4Is(sitagliptin)may exert a less potent effect on HbA1C, FPG, PPG, and weight reduction than GLP-1 receptor agonists in obese or overweight patients; There are also differences between different drugs in one single type. Observing the effects of hypoglycemic drugs requires studies with large samples and long term observation. Therefore, better evidences are needed to provide a compelling reason for their use in different situations and different population subgroups. A network evidence set of the three types of new hypoglycemic drugs can be constructed based on all the RCTs in this constantly updated database. With the help of real-world research partners, in-depth discussion on the differences of the three types of new hypoglycemic drugs in a single outcome (effectiveness, safety and economy) and multiple comprehensive outcomes can be conducted by network meta-analysis and IPD meta-analysis. After evaluating the quality of these above evidences, further summaries and recommendations can be made combining with the benefit-risk relationship based on different decision-making scenarios and expert opinions. We hope that more comprehensive and multi-dimensional evidences of the comparison of the three types of new hypoglycemic drugs will be obtained through this evidence-based evaluation research. These evidences will provide more reliable basis for clinicians when making decisions, provide reference for guideline makers and regulatory decision-making departments. It will enhance the accuracy and confidence when we make decisions, and actually bring the greatest health benefits to patients with T2DM, which also provide a reference for the evaluation of other drugs.
Contributor(s): Feng Sun, Fengqi Liu, Zuoxiang Liu, Pei Li, Shuqing Yu, Le Gao, Sanbao Chai, Shanshan Wu, Zhirong Yang, Sheng Han, Liang Zhang, Haining Wang, Linong Ji, Siyan Zhan.
DOI: DOI pending.
Funding Source: The National Natural Science Foundation of China(no.71673003); National Natural Science Foundation of China(no.81302508); National Natural Science Foundation of China(no.72074011)
Methodology Description: During literature search, all the names of the three types of new hypoglycemic drugs, as well as all the listed drugs and searchable products in these three categories were covered. These interventions are showed as follow. DPP-4Is:Sitagliptin, Vildagliptin, Linagliptin, Saxagliptin, Alogliptin, Gemigliptin, Anagliptin, Teneligliptin, Trelagliptin, Retagliptin, Melogliptin, Evogliptin, Carmegliptin, Omarigliptin, Dutogliptin, Diabeglipt, Elant, Glucal, Teneglucon Veriglip, Glipten, PF-734200, Suganon, LC-150444, DA-1229, Januvia, Janumet, Juvisync, Galvus, Eucreas, GalvusMet, Onglyza, KombiglyzeXR, Qtern, Nesina, Oseni, Kazano, Vipidia, Vipdoment, Trajenta, Gemiglo, Beskoa, Tenelia; GLP-1RAs:Liraglutide, Exenatide, Albiglutide, Taspoglutide, Lixisenatide, Dulaglutide, Semaglutide, Byetta, Bydureon, Victoza, Lyxumia, Adlyxin, Tanzeum, Eperzan, Trulicity, AVE-0010, Ozempic; SGLT-2Is:Dapagliflozin, Canagliflozin, Empagliflozin, Luseogliflozin, Ipragliflozin, Ertugliflozin, Sotagliflozin, Tofogliflozin, Rongliflozin, Janagliflozin, Bexagliflozin, Remogliflozin, Forxiga, Invokana, Jardiance, Glyxambi, JNJ-28431754, TA-7284, BI-10773, SAR-439954, LX-4211, EGT-0001442, ASP-1941。 We searched the following databases for primary studies for the periods in parentheses: MEDLINE(1966 to March 2019), Embase(1974 to March 2019), and Cochrane Library(1995 to March 2019). We developed a search strategy based on the purposes of this research and the analysis of MeSH terms. The articles which were selected out from above mentioned databases were exported and gathered into an EndNote library(EndNote version X9). We used the duplication check feature in EndNote to scan for duplicate articles, and deleted duplicates more precisely by two reviewers during screening. Then two reviewers screened these articles by their titles and abstracts independently, classified those which meet the criterion, and excluded those which do not. Then detailed data, including study design, treatments for the comparison groups, baseline characteristics, outcome indicators and adverse events, was extracted from each study by using standardized protocols and pooled into ADDIS(Aggregate Data Drug Information System). The overall outcomes covered in our database can be classified into three clusters: effectiveness outcomes, safety outcomes, and economy outcomes. The specific outcomes are showed as follow. 1. Effectiveness outcomes: Blood glucose related indicators (glycated hemoglobin, fasting serum glucose, 2 hours postprandial serum glucose, fasting C peptide, HOMA-β, HOMA-IR, etc.); Blood lipid related indicators (low density lipoprotein cholesterol, high-density lipoprotein cholesterol, total cholesterol, triglyceride, etc.); Other indicators (estimated glomerular filtration rate, body weight, body mass index, waist circumference, waist-to-hip ratio, systolic blood pressure, diastolic blood pressure, heart rate, etc.). 2. Safety outcomes: All cause motality; Adverse gastrointestinal events (nausea, vomiting, diarrhea, constipation, indigestion, gastroenteritis, decrease of appetite, appendicitis, cholelithiasis, etc.); Respiratory diseases (respiratory failure, acute respiratory distress syndrome, asthma, chronic obstructive pulmonary disease, bronchitis, pneumonia, etc.); Endocrine decompensation (hyperglycemia, hypoglycemia, hyperthyroidism, etc.); Cardiovascular diseases (major adverse cardiovascular events, stroke, angina, arrhythmia, myocardial Infarction, aortic aneurysm, coronary atherosclerosis, atrioventricular block, cardiac arrest, hypertension, etc.); Liver and renal dysfunction (cirrhosis, kidney stones, acute renal failure, hepatic encephalopathy, liver steatosis, liver failure, etc.); Infectious diseases (septicemia, abdominal abscess, urinary tract infection, cellulitis, flu, etc.); Nervous system dysfunction (dizziness, headache, neurasthenia, migraine, etc.); Tumors (digestive system tumors, bladder benign tumor, thyroid cancer, brain tumor, breast cancer, etc.); Mental disorders (anxiety, depression, cognitive impairment, paresthesia, etc.); Musculoskeletal diseases (arthritis, arthralgia, back pain, fractures, muscle weakness, etc.); Diabetic complications (diabetic foot, diabetic ketoacidosis, diabetic retinopathy, diabetic nephropathy, etc.) and other adverse events. 3. Economy outcomes: drug cost, quality-adjusted life years (QALYs), drug incremental cost effectiveness ratio (ICER), life expectancy, etc. Population baseline characteristics were also collected, include: gender, age, ethnicity, duration of type 2 diabetes, whether they have cardiovascular and cerebrovascular diseases, whether they have a family history of type 2 diabetes, and other related baseline indicators (glycated hemoglobin, fasting serum glucose, 2 hours postprandial serum glucose, body weight, body mass index, waist circumference, waist-to-hip ratio, etc.). Network meta-analysis can be performed base on this database. All of comprehensive information was included in this database, which is essential for further statistical analysis. Studies that focus on a single outcome have certain limitations. So in the future, we will use this database to explore the benefit-risk of these drugs with multiple outcomes. The models we are interested in are multi-criteria decision analysis (MCDA) model and its derivative model stochastic multicriteria acceptability analysis (SMAA). When we conduct benefit/risk analysis, we will make good use of indirect comparative studies through network meta-analysis.

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