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Completed Systematic Reviews




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We searched the PubMed, Embase and Cochrane Library databases for original English-language articles, and collected unpublished studies’ data from clinicaltrial.org and other sources,we also manually search reference list of review literatures and grey literatures.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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Integrating Palliative Care in Ambulatory Care of Non-Cancer Serious Chronic Illness


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Statistics: 40 Studies, 15 Key Questions, 1 Extraction Form,
Date Published: Oct 22, 2020 03:42PM
Description: Objectives. To evaluate availability, effectiveness, and implementation of interventions for integrating palliative care into ambulatory care for U.S.-based adults with serious life-threatening chronic illness or conditions other than cancer and their caregivers We evaluated interventions addressing identification of patients, patient and caregiver education, shared decision-making tools, clinician education, and models of care. Data sources. We searched key U.S. national websites (March 2020) and PubMed®, CINAHL, and the Cochrane Central Register of Controlled Trials (through May 2020). We also engaged Key Informants. Review methods. We completed a mixed-methods review; we sought, synthesized, and integrated Web resources; quantitative, qualitative and mixed-methods studies; and input from patient/caregiver and clinician/stakeholder Key Informants. Two reviewers screened websites and search results, abstracted data, assessed risk of bias or study quality, and graded strength of evidence (SOE) for key outcomes: health-related quality of life, patient overall symptom burden, patient depressive symptom scores, patient and caregiver satisfaction, and advance directive documentation. We performed meta-analyses when appropriate. Results. We included 46 Web resources, 20 quantitative effectiveness studies, and 16 qualitative implementation studies across primary care and specialty populations. Various prediction models, tools, and triggers to identify patients are available, but none were evaluated for effectiveness or implementation. Numerous patient and caregiver education tools are available, but none were evaluated for effectiveness or implementation. All of the shared decision-making tools addressed advance care planning; these tools may increase patient satisfaction and advance directive documentation compared with usual care (SOE: Low). Patients and caregivers prefer advance care planning discussions grounded in patient and caregiver experiences with individualized timing. Although numerous education and training resources for non-palliative care clinicians are available, we were unable to draw conclusions about implementation, and none have been evaluated for effectiveness. Models for integrating palliative care were not more effective than usual care for improving health-related quality of life or patient depressive symptom scores (SOE: Moderate) and may have little to no effect on increasing patient satisfaction or decreasing overall symptom burden (SOE: Low), but models for integrating palliative care were effective for increasing advance directive documentation (SOE: Moderate). Multimodal interventions may have little to no effect on increasing advance directive documentation (SOE: Low) and other graded outcomes were not assessed. For utilization, models for integrating palliative care were not more effective than usual care for decreasing hospitalizations; we were unable to draw conclusions about most other aspects of utilization or cost and resource use. We were unable to draw conclusions about caregiver satisfaction or specific characteristics of models for integrating palliative care. Patient preferences for appropriate timing of palliative care varied; costs, additional visits, and travel were seen as barriers to implementation. Conclusions. For integrating palliative care into ambulatory care for serious illness and conditions other than cancer, advance care planning shared decision-making tools and palliative care models were the most widely evaluated interventions and may be effective for improving only a few outcomes. More research is needed particularly on identification of patients for these interventions; education for patients, caregivers, and clinicians; shared decision-making tools beyond advance care planning and advance directive completion; and specific components, characteristics, and implementation factors in models for integrating palliative care.
Contributor(s): Sydney M. Dy, M.D., M.S., F.A.A.H.P.M. Julie M. Waldfogel, Pharm.D. Danetta H. Sloan, Ph.D., M.S.W. Valerie Cotter, Dr.NP., M.S.N. Susan Hannum, Ph.D. JaAlah-Ai Heughan, M.S. Linda Chyr, M.P.H. Lyndsay DeGroot, R.N., B.S.N. Renee Wilson, M.S. Allen Zhang, B.A. Darshan Mahabare, B.A. David S. Wu, M.D., F.A.A.H.P.M. Karen A. Robinson, Ph.D.
DOI: DOI pending.
Funding Source: Agency for Healthcare Research and Quality
Methodology Description: Review Approach This mixed methods review includes a grey literature search and systematic reviews of the published quantitative and qualitative, mixed-methods, and process evaluation literature, as well as an integration of results across these sources and review methods. We followed the methods outlined in the Agency for Healthcare Research and Quality’s (AHRQ’s) Methods Guide for Effectiveness and Comparative Effectiveness Reviews (refer to the Methods Appendix for additional details). We have reported the results of the systematic review in accordance with the Preferred Items for Reporting in Systematic Reviews and Meta-Analyses (PRISMA).8 Integrative review methods are based on the 2017 Cochrane guidance, Qualitative and Implementation Methods Group Guidance Paper 5: Methods for integrating qualitative and implementation evidence within intervention effectiveness reviews,9 and the Joanna Briggs Institute methods for mixed methods systematic reviews.10 AHRQ developed the topic of this systematic review. We recruited Key Informants (KIs) to refine the topic and key questions and provide input on the integration of results. We recruited a Technical Expert Panel (TEP) to provide input on all details of the protocol, including outcomes. The KIs and TEP represented palliative care, primary care, and other ambulatory specialties, and included physicians, nurses, and social workers; we also included patient advocate KIs. With the feedback from the TEP, KIs, AHRQ, and our partners, the National Institute for Nursing Research, and the Health Resources and Services Administration, we finalized the protocol and posted it on the AHRQ Effective Health Care Program’s website (www.effectivehealthcare.ahrq.gov). Study Selection We searched PubMed, CINAHL, and the Cochrane Central Register of Controlled Trials in May 2020. Two team members independently applied eligibility criteria (Table 1 and Table 2) to citations identified by these searches. In March 2020, we searched key U.S. national websites identified as relevant to the Key Questions and refined with input from AHRQ and Technical Experts, including websites from palliative care organizations, primary care and specialty healthcare professional organizations, government organizations, foundations with a major focus in palliative care, and patient organizations (see Methods Appendix A-2 for full list of websites searched). Two reviewers simultaneously screened available website content for eligibility based on the Population, Intervention, Comparisons, Outcomes, Type of study, Setting (PICOTS); specific relevance to integrating palliative care into ambulatory care in the United States; and our criterion that materials must have been developed or updated within the last 5 years. Full details on the search strategy and eligibility criteria are in the Methods Appendix (Appendix A-4). Paired investigators abstracted data sequentially. For quantitative studies, reviewers assessed risk of bias independently. We used the Cochrane Risk of Bias Tool, Version 2, for assessing the risk of bias of randomized controlled trials (RCTs).12 For non-randomized studies, we used the Cochrane Risk of Bias Assessment Tool for Non-Randomized Studies of Interventions (ROBINS-I) tool.13 For qualitative and mixed-methods studies, reviewers independently assessed study quality using the Joanna Briggs Institute Checklist14, 15 (see Methods Appendix A-12 for more details). In addition to seeking feedback from the Key Informants on the key questions, we engaged two separate groups of Key Informants to provide input on the integrative review process: one group of patients and caregivers; and one group of stakeholders, including practicing clinicians, relevant professional and consumer organizations, purchasers of healthcare, representatives of Learning Health Systems, and others with experience making healthcare decisions. We compiled key issues elicited from the Key Informants and used those to inform our analysis of the qualitative, mixed-methods, and process evaluation literature and the overall integration. At the end of the project, we also conducted sessions with the Key Informants to refine the analysis and integration results.

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Maternal, Fetal, and Child Outcomes of Mental Health Treatments in Women: A Systematic Review of Perinatal Pharmacological Interventions


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Statistics: 168 Studies, 4 Key Questions, 1 Extraction Form,
Date Published: Oct 05, 2020 03:35AM
Description: A systematic review to assess the efficacy and comparative effectiveness of pharmacological interventions for pregnant and postpartum women with psychiatric disorders.
Contributor(s): To be announced after the final report has been completed.
DOI: DOI pending.
Funding Source: AHRQ
Methodology Description: Systematic review

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Platelet-Rich Plasma for Wound Care in the Medicare Population


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Statistics: 49 Studies, 5 Key Questions, 3 Extraction Forms,
Date Published: Oct 02, 2020 01:12PM
Description: Objectives. To evaluate the effectiveness of autologous platelet-rich plasma (PRP) in individuals with lower extremity diabetic ulcers, lower extremity venous ulcers, and pressure ulcers. Data sources. MEDLINE, Embase, Cochrane Central Registrar of Controlled Trials, Cochrane Database of Systematic Reviews, PsycINFO, Scopus and various grey literature sources from database inception to June 11, 2020. Review methods. We included randomized controlled trials (RCTs) and comparative observational studies that compared PRP to any other wound care without PRP in adult patients. Pairs of independent reviewers selected and appraised studies. Meta-analysis was conducted when appropriate and the strength of evidence (SOE) was determined based on a priori plan. Results. We included 27 studies (22 randomized, 5 comparative observational studies, total of 1,796 patients). 15 studies enrolled patients with lower extremity diabetic ulcers, 11 enrolled patients with lower extremity venous ulcers, and 2 enrolled patients with pressure ulcers in any location. Followup after intervention ranged from no followup to 11 months. The available studies suffered from important limitations, such as inadequate description of offloading and wound care procedures, wound characteristics, platelet-rich plasma formulation techniques, concentration and volume; inadequate length of followup; and lack of stratification by comorbidities and other patient characteristics including older adults. Compared with management without PRP, PRP therapy increased complete wound closure or healing in lower extremity diabetic ulcers (RR: 1.20; 95% CI: 1.09 to 1.32, moderate SOE), shortened the time to complete wound closure, and reduced wound area and depth (low SOE), although Medicare-eligible older adults were underrepresented in the included studies. No significant changes were found in terms of wound infection, amputation, wound recurrence, or hospitalization. In patients with lower extremity venous ulcers, the SOE was insufficient to estimate an effect on critical outcomes, such as complete wound closure or time to complete wound closure. Similarly, evidence was insufficient to estimate an effect on any outcome in pressure ulcers. There was no statistically significant difference in death, total adverse events or serious adverse events between PRP and management without PRP. Conclusions. Autologous platelet-rich plasma based on moderate SOE increases complete wound closure or healing, and low SOE shortens healing time and reduces wound size in individuals with lower extremity diabetic ulcers. The evidence is insufficient to estimate an effect of autologous platelet-rich plasma on wound healing in individuals with lower extremity venous ulcers or pressure ulcers.
Contributor(s): Wenchun Qu, M.D. Zhen Wang, Ph.D. Christine Hunt, D.O. Allison S. Morrow, B.A. Meritxell Urtecho, M.D. Mustapha Amin, M.D. Sahrish Shah, M.B.B.S. Bashar Hasan, M.D. Rami Abd-Rabu, M.B.B.S. Zack Ashmore, M.D. Eva Kubrova, M.D. Larry J. Prokop, M.L.S. M. Hassan Murad, M.D., M.P.H.
DOI: DOI pending.
Funding Source: AHRQ
Methodology Description: We developed an analytic framework to guide the process of the systematic review. We followed the established methodologies of systematic reviews as outlined in Agency for Healthcare Research and Quality (AHRQ) Methods Guide for Comparative Effectiveness Reviews. The reporting complies with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statements. The study protocol is published on AHRQ website and registered in the international prospective register of systematic reviews (PROSPERO #: CRD42020172817). The full report details our literature search strategy, inclusion and exclusion criteria, data synthesis, assessments of risk of bias, and strength of evidence (SOE). We assigned SOE rating as high, moderate, low, or ‘insufficient evidence to estimate an effect’. High was rated when we were very confident that the estimate of effect lies close to the true effect (the body of evidence has few or no deficiencies and is judged to be stable). Moderate was rated if we were moderately confident that the estimate of effect lies close to the true effect (the body of evidence has some deficiencies and is judged to be likely stable). Low, we had limited confidence that the estimate of effect lies close to the true effect (the body of evidence has major or numerous deficiencies and is likely unstable), and insufficient if we had no evidence, are unable to estimate an effect, or have no confidence in the estimate of effect.

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