Publications by authors named "Tarek Nayfeh"

22 Publications

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Association of study design features and treatment effects in trials of chronic medical conditions: a meta-epidemiological study.

BMJ Evid Based Med 2021 Jul 1. Epub 2021 Jul 1.

The Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA.

Objectives: To evaluate the association of study design features and treatment effects in randomised controlled trials (RCTs) evaluating therapies for individuals with chronic medical conditions.

Design: Meta-epidemiological study.

Setting: RCTs from meta-analyses published in the 10 general medical journals with the highest impact factor published between 1 January 2007 and 10 June 2019 and evaluated a drug, procedure or device treatment of chronic medical conditions.

Main Outcome Measures: The association between trial design features and the effect size, reporting a ratio of ORs (ROR) and 95% confidence interval (CI).

Results: We included 1098 trials from 86 meta-analyses. The most common outcome in the trials was mortality (52%), followed by disease progression (16%) and adverse events (12%). Lack of blinding of patients and study personnel was associated with a larger treatment effect (ROR 1.12; 95% CI 1.00 to 1.25). There was no statistically significant association with random sequence generation, allocation concealment, blinding of outcome assessors, incomplete outcome data, whether trials were stopped early, study funding, type of interventions or with type of outcomes (objective vs subjective).

Conclusion: The meta-epidemiological study did not demonstrate a clear pattern of association between risk of bias indicators and treatment effects in RCTs in chronic medical conditions. The unpredictability of the direction of bias emphasises the need to make every attempt to adhere to blinding, allocation concealment and reduce attrition bias.

Trial Registration Number: Not applicable.
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http://dx.doi.org/10.1136/bmjebm-2021-111667DOI Listing
July 2021

Association of vitamin D deficiency with COVID-19 infection severity: Systematic review and meta-analysis.

Clin Endocrinol (Oxf) 2021 Jun 23. Epub 2021 Jun 23.

Division of Pediatric Endocrinology, Department of Pediatric and Adolescent Medicine, Mayo Clinic, Rochester, Minnesota, USA.

Background: We sought to evaluate the association between vitamin D deficiency and the severity of coronavirus disease 2019 (COVID-19) infection.

Methods: Multiple databases from 1 January 2019 to 3 December 2020 were searched for observational studies evaluating the association between vitamin D deficiency and severity of COVID-19 infection. Independent reviewers selected studies and extracted data for the review. The main outcomes of interest were mortality, hospital admission, length of hospital stay and intensive care unit admission.

Results: Seventeen observational studies with 2756 patients were included in the analyses. Vitamin D deficiency was associated with significantly higher mortality (odds ratio [OR]: 2.47, 95% confidence interval [CI]: 1.50-4.05; 12 studies; hazard ratio [HR]: 4.11, 95% CI: 2.40-7.04; 3 studies), higher rates of hospital admissions (OR: 2.18, 95% CI: 1.48-3.21; 3 studies) and longer hospital stays (0.52 days; 95% CI: 0.25-0.80; 2 studies) as compared to nonvitamin D deficient status. Subgroup analyses based on different cut-offs for defining vitamin D deficiency, study geographic locations and latitude also showed similar trends.

Conclusions: Vitamin D deficiency is associated with greater severity of COVID-19 infection. Further studies are warranted to determine if vitamin D supplementation can decrease the severity of COVID-19.
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http://dx.doi.org/10.1111/cen.14540DOI Listing
June 2021

A Systematic Review Supporting the Society for Vascular Surgery Guidelines on the Management of Carotid Artery Disease.

J Vasc Surg 2021 Jun 18. Epub 2021 Jun 18.

Evidence-Based Practice Research Program, Mayo Clinic, MN, USA; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, MN, USA. Electronic address:

Background: To support the development of guidelines on the management of carotid disease, a writing committee from the Society for Vascular Surgery has commissioned this systematic review.

Methods: We searched multiple data bases for studies addressing 5 questions: medical management vs. carotid revascularization (CEA) in asymptomatic patients, CEA vs. CAS in symptomatic low surgical risk patients, the optimal timing of revascularization after acute stroke, screening high risk patients for carotid disease, and the optimal sequence of interventions in patients with combined coronary and carotid disease. Studies were selected and appraised by pairs of independent reviewers. Meta-analyses were performed when feasible.

Results: Medical management compared to carotid interventions in asymptomatic patients was associated with better early outcome during the first 30 days. However, CEA was associated with significantly lower long-term rate of stroke/death at 5 years. In symptomatic low risk surgical patients, CEA was associated with lower risk of stroke, but a significant increase in MI compared to CAS during the first 30 days. When the long-term outcome of transfemoral CAS vs. CEA in symptomatic patients were examined using pre-planned pooled analysis of individual patient data from four randomized trials, the risk of death or stroke within 120 days of the index procedure was 5.5% for CEA and 8.7% for CAS, which lends support that over the long-term, CEA has superior outcome than transfemoral CAS. When managing acute stroke, the comparison of CEA during the first 48 hours to that between day 2 and day14 did not reveal a statistically significant difference on outcomes during the first 30 days. Registry data show good results with CEA performed in the first week, but not within the first 48 hours. A single risk factor, aside from PAD, was associated with low carotid screening yield. Multiple risk factors greatly increase the yield of screening. Evidence on the timing of interventions in patients with combined carotid and coronary disease was sparse and imprecise. Patients without carotid symptoms, who had the carotid intervention first, compared to a combined carotid intervention and CABG, had better outcomes.

Conclusions: This updated evidence summary will support the SVS clinical practice guidelines for commonly raised clinical scenarios. CEA was superior to medical therapy in long-term prevention of stroke/death over medical therapy. CEA was also superior to transfemoral CAS in minimizing long-term stroke/death for symptomatic low risk surgical patients. CEA should optimally be performed between 2-14 days from the onset of acute stroke. Having multiple risk factors increases the value of carotid screening.
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http://dx.doi.org/10.1016/j.jvs.2021.06.001DOI Listing
June 2021

Acute Treatments for Episodic Migraine in Adults: A Systematic Review and Meta-analysis.

JAMA 2021 06;325(23):2357-2369

Mayo Clinic Evidence-based Practice Center, Rochester, Minnesota.

Importance: Migraine is common and can be associated with significant morbidity, and several treatment options exist for acute therapy.

Objective: To evaluate the benefits and harms associated with acute treatments for episodic migraine in adults.

Data Sources: Multiple databases from database inception to February 24, 2021.

Study Selection: Randomized clinical trials and systematic reviews that assessed effectiveness or harms of acute therapy for migraine attacks.

Data Extraction And Synthesis: Independent reviewers selected studies and extracted data. Meta-analysis was performed with the DerSimonian-Laird random-effects model with Hartung-Knapp-Sidik-Jonkman variance correction or by using a fixed-effect model based on the Mantel-Haenszel method if the number of studies was small.

Main Outcomes And Measures: The main outcomes included pain freedom, pain relief, sustained pain freedom, sustained pain relief, and adverse events. The strength of evidence (SOE) was graded with the Agency for Healthcare Research and Quality Methods Guide for Effectiveness and Comparative Effectiveness Reviews.

Findings: Evidence on triptans and nonsteroidal anti-inflammatory drugs was summarized from 15 systematic reviews. For other interventions, 115 randomized clinical trials with 28 803 patients were included. Compared with placebo, triptans and nonsteroidal anti-inflammatory drugs used individually were significantly associated with reduced pain at 2 hours and 1 day (moderate to high SOE) and increased risk of mild and transient adverse events. Compared with placebo, calcitonin gene-related peptide receptor antagonists (low to high SOE), lasmiditan (5-HT1F receptor agonist; high SOE), dihydroergotamine (moderate to high SOE), ergotamine plus caffeine (moderate SOE), acetaminophen (moderate SOE), antiemetics (low SOE), butorphanol (low SOE), and tramadol in combination with acetaminophen (low SOE) were significantly associated with pain reduction and increase in mild adverse events. The findings for opioids were based on low or insufficient SOE. Several nonpharmacologic treatments were significantly associated with improved pain, including remote electrical neuromodulation (moderate SOE), transcranial magnetic stimulation (low SOE), external trigeminal nerve stimulation (low SOE), and noninvasive vagus nerve stimulation (moderate SOE). No significant difference in adverse events was found between nonpharmacologic treatments and sham.

Conclusions And Relevance: There are several acute treatments for migraine, with varying strength of supporting evidence. Use of triptans, nonsteroidal anti-inflammatory drugs, acetaminophen, dihydroergotamine, calcitonin gene-related peptide antagonists, lasmiditan, and some nonpharmacologic treatments was associated with improved pain and function. The evidence for many other interventions, including opioids, was limited.
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http://dx.doi.org/10.1001/jama.2021.7939DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8207243PMC
June 2021

A systematic review and meta-analysis of treatment and natural history of popliteal artery aneurysms.

J Vasc Surg 2021 May 29. Epub 2021 May 29.

Evidence-based Practice Center, Mayo Clinic Rochester, Rochester, Minn. Electronic address:

Objective: To summarize the best available evidence comparing open vs endovascular popliteal artery aneurysm (PAA) repair. We also summarized the natural history of PAAs to support of the Society for Vascular Surgery guidelines.

Methods: We searched MEDLINE, EMBASE, Cochrane databases, and Scopus for studies of patients with PAAs treated with an open vs an endovascular approach. We also included studies of natural history of untreated patients. Studies were selected and appraised by pairs of independent reviewers. A meta-analysis was performed when appropriate.

Results: We identified 32 original studies and 4 systematic reviews from 2191 candidate references. Meta-analysis showed that compared with the endovascular approach, open surgical repair was associated with higher primary patency at 1 year (odds ratio [OR], 2.10; 95% confidence interval [CI], 1.41-3.12), lower occlusion rate at 30 days (OR, 0.41; 95% CI, 0.24-0.68) and fewer reinterventions (OR, 0.28; 95% CI, 0.17-0.45), but a longer hospital stay (standardized mean difference, 2.16; 95% CI, 1.23-3.09) and more wound complications (OR, 5.18; 95% CI, 2.19-12.26). There was no statistically significant difference in primary patency at 3 years (OR, 1.38; 95% CI, 0.97-1.97), secondary patency (OR, 1.59; 95% CI, 0.84-3.03), mortality at the longest follow-up (OR, 0.49; 95% CI, 0.21-1.17), mortality at 30 days (OR, 0.28; 95% CI, 0.06-1.36), or amputation (incidence rate ratio, 0.85; 95% CI, 0.56-1.31). The certainty in these estimates was, in general, low. Studies of PAA natural history suggest that thromboembolic complications and amputation develop at a mean observation time of 18 months and they are frequent. One study showed that at 5 years, approximately one-half of the patients had complications.

Conclusions: This systematic review provides event rates for outcomes important to patients with PAAs. Despite the low certainty of the evidence, these rates along with surgical expertise and anatomic feasibility can help patients and surgeons to engage in shared decision-making.
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http://dx.doi.org/10.1016/j.jvs.2021.05.023DOI Listing
May 2021

Magnitude and Time-Trend Analysis of Post-Endoscopy Esophageal Adenocarcinoma: A Systematic Review and Meta-analysis.

Clin Gastroenterol Hepatol 2021 Apr 23. Epub 2021 Apr 23.

Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, Aurora, Colorado. Electronic address:

Background & Aims: Identification of postendoscopy esophageal adenocarcinoma (PEEC) among Barrett's esophagus (BE) patients presents an opportunity to improve survival of esophageal adenocarcinoma (EAC). We aimed to estimate the proportion of PEEC within the first year after BE diagnosis.

Methods: Multiple databases (Medline, Embase, Scopus, and Cochrane databases) were searched until September 2020 for original studies with at least 1-year follow-up evaluation that reported EAC and/or high-grade dysplasia (HGD) in the first year after index endoscopy in nondysplastic BE, low-grade dysplasia, or indefinite dysplasia. The proportions of PEEC defined using EAC alone and EAC+HGD were calculated by dividing EAC or EAC+HGD in the first year over the total number of EAC or EAC+HGD, respectively.

Results: We included 52 studies with 145,726 patients and a median follow-up period of 4.8 years. The proportion of PEEC (EAC) was 21% (95% CI, 13-31) and PEEC (EAC+HGD) was 26% (95% CI, 19-34). Among studies with nondysplastic BE only, the PEEC (EAC) proportion was 17% (95% CI, 11-23) and PEEC (EAC+HGD) was 14% (95% CI, 8-19). Among studies with 5 or more years of follow-up evaluation, the PEEC (EAC) proportion was 10% and PEEC (EAC+HGD) was 19%. Meta-regression analysis showed a strong inverse relationship between PEEC and incident EAC (P < .001). The PEEC (EAC) proportion increased from 5% in studies published before 2000 to 30% after 2015. Substantial heterogeneity was observed for most analyses.

Conclusions: PEEC accounts for a high proportion of HGD/EACs and is proportional to reduction in incident EAC. Using best endoscopic techniques now and performing future research on improving neoplasia detection through implementation of quality measures and educational tools is needed to reduce PEEC.
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http://dx.doi.org/10.1016/j.cgh.2021.04.032DOI Listing
April 2021

A Systematic Review Supporting the American Society for Dermatologic Surgery Guidelines on the Prevention and Treatment of Adverse Events of Injectable Fillers.

Dermatol Surg 2021 02;47(2):227-234

Evidence-Based Practice Research Program, Mayo Clinic, Rochester, Minnesota.

Background: As the use of injectable skin fillers increase in popularity, an increase in the reported adverse events is expected.

Objective: This systematic review supports the development of American Society for Dermatologic Surgery practice guideline on the management of adverse events of skin fillers.

Methods And Materials: Several databases for studies on risk factors or treatments of injection-related visual compromise (IRVC), skin necrosis, inflammatory events, and nodules were searched. Meta-analysis was conducted when feasible.

Results: The review included 182 studies. However, IRVC was very rare (1-2/1,000,000 patients) but had poor prognosis with improvement in 19% of cases. Skin necrosis was more common (approximately 5/1,000) with better prognosis (up to 77% of cases showing improvement). Treatments of IRVC and skin necrosis primarily depend on hyaluronidase injections. Risk of skin necrosis, inflammatory events, and nodules may be lower with certain fillers, brands, injection techniques, and volume. Treatment of inflammatory events and nodules with antibiotics, corticosteroids, 5-FU, and hyaluronidase was associated with high response rate (75%-80%). Most of the studies were small and noncomparative, making the evidence certainty very low.

Conclusion: Practitioners must have adequate knowledge of anatomy, elicit history of skin filler use, and establish preemptive protocols that prepare the clinical practice to manage complications.
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http://dx.doi.org/10.1097/DSS.0000000000002911DOI Listing
February 2021

Vasopressin in vasoplegic shock: A systematic review.

World J Crit Care Med 2020 Dec 18;9(5):88-98. Epub 2020 Dec 18.

Department of Anesthesia, Mayo Clinic, Rochester, MN 55905, United States.

Background: Vasoplegic shock is a challenging complication of cardiac surgery and is often resistant to conventional therapies for shock. Norepinephrine and epinephrine are standards of care for vasoplegic shock, but vasopressin has increasingly been used as a primary pressor in vasoplegic shock because of its unique pharmacology and lack of inotropic activity. It remains unclear whether vasopressin has distinct benefits over standard of care for patients with vasoplegic shock.

Aim: To summarize the available literature evaluating vasopressin non-vasopressin alternatives on the clinical and patient-centered outcomes of vasoplegic shock in adult intensive care unit (ICU) patients.

Methods: This was a systematic review of vasopressin in adults (≥ 18 years) with vasoplegic shock after cardiac surgery. Randomized controlled trials, prospective cohorts, and retrospective cohorts comparing vasopressin to norepinephrine, epinephrine, methylene blue, hydroxocobalamin, or other pressors were included. The primary outcomes of interest were 30-d mortality, atrial/ventricular arrhythmias, stroke, ICU length of stay, duration of vasopressor therapy, incidence of acute kidney injury stage II-III, and mechanical ventilation for greater than 48 h.

Results: A total of 1161 studies were screened for inclusion with 3 meeting inclusion criteria with a total of 708 patients. Two studies were randomized controlled trials and one was a retrospective cohort study. Primary outcomes of 30-d mortality, stroke, ventricular arrhythmias, and duration of mechanical ventilation were similar between groups. Conflicting results were observed for acute kidney injury stage II-III, atrial arrhythmias, duration of vasopressors, and ICU length of stay with higher certainty of evidence in favor of vasopressin serving a protective role for these outcomes.

Conclusion: Vasopressin was not found to be superior to alternative pressor therapy for any of the included outcomes. Results are limited by mixed methodologies, small overall sample size, and heterogenous populations.
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http://dx.doi.org/10.5492/wjccm.v9.i5.88DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7754532PMC
December 2020

Anticoagulation in COVID-19: A Systematic Review, Meta-analysis, and Rapid Guidance From Mayo Clinic.

Mayo Clin Proc 2020 11 31;95(11):2467-2486. Epub 2020 Aug 31.

Evidence-based Practice Center and Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN. Electronic address:

A higher risk of thrombosis has been described as a prominent feature of coronavirus disease 2019 (COVID-19). This systematic review synthesizes current data on thrombosis risk, prognostic implications, and anticoagulation effects in COVID-19. We included 37 studies from 4070 unique citations. Meta-analysis was performed when feasible. Coagulopathy and thrombotic events were frequent among patients with COVID-19 and further increased in those with more severe forms of the disease. We also present guidance on the prevention and management of thrombosis from a multidisciplinary panel of specialists from Mayo Clinic. The current certainty of evidence is generally very low and continues to evolve.
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http://dx.doi.org/10.1016/j.mayocp.2020.08.030DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7458092PMC
November 2020

Immune Checkpoint Inhibitors for Unresectable Hepatocellular Carcinoma.

Vaccines (Basel) 2020 Oct 19;8(4). Epub 2020 Oct 19.

Gastroenterology Unit, Department of Medical Sciences, Ospedali Riuniti di Foggia, 71122 Foggia, Italy.

Despite the advances in screening protocols and treatment options, hepatocellular carcinoma (HCC) is still considered to be the most lethal malignancy in patients with liver cirrhosis. Moreover, the survival outcomes after failure of first-line therapy for unresectable HCC is still poor with limited therapeutic options. One of these options is immune checkpoint inhibitors. The aim of this study is to comprehensively review the efficacy and safety of immune checkpoint inhibitors for patients with HCC.
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http://dx.doi.org/10.3390/vaccines8040616DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7712941PMC
October 2020

Weight Loss and Serum Lipids in Overweight and Obese Adults: A Systematic Review and Meta-Analysis.

J Clin Endocrinol Metab 2020 12;105(12)

Evidence-Based Practice Center, Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota.

Background: Excess adipose tissue is associated with an abnormal lipid profile that may improve with weight reduction. In this meta-analysis, we aimed to estimate the magnitude of change in lipid parameters associated with weight loss in adults who are overweight or obese.

Methods: We searched MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, and Scopus from 2013 to September, 2018. We included randomized controlled trials (RCTs) that evaluated interventions to treat adult obesity (lifestyle, pharmacologic and surgical) with follow-up of 6 months or more.

Results: We included 73 RCTs with moderate-to-low risk of bias, enrolling 32 496 patients (mean age, 48.1 years; weight, 101.6 kg; and body mass index [BMI], 36.3 kg/m2). Lifestyle interventions (diet, exercise, or both), pharmacotherapy, and bariatric surgery were associated with reduced triglyceride (TG) and low-density lipoprotein cholesterol (LDL-C) concentrations and increased high-density lipoprotein cholesterol (HDL-C) at 6 and 12 months. The following data are for changes in lipid parameters after 12 months of the intervention with 95% CI. Following lifestyle interventions, per 1 kg of weight lost, TGs were reduced by -4.0 mg/dL (95% CI, -5.24 to -2.77 mg/dL), LDL-C was reduced by -1.28 mg/dL (95% CI, -2.19 to -0.37 mg/dL), and HDL-C increased by 0.46 mg/dL (95% CI, 0.20 to 0.71 mg/dL). Following pharmacologic interventions, per 1 kg of weight lost, TGs were reduced by -1.25 mg/dL (95% CI, -2.94 to 0.43 mg/dL), LDL-C was reduced by -1.67 mg/dL (95% CI, -2.28 to -1.06 mg/dL), and HDL-C increased by 0.37 mg/dL (95% CI, 0.23 to 0.52 mg/dL). Following bariatric surgery, per 1 kg of weight lost, TGs were reduced by -2.47 mg/dL (95% CI, -3.14 to -1.80 mg/dL), LDL-C was reduced by -0.33 mg/dL (95% CI, -0.77 to 0.10 mg/dL), and HDL-C increased by 0.42 mg/dL (95% CI, 0.37 to 0.47 mg/dL). Low-carbohydrate diets resulted in reductions in TGs and increases in HDL-C, whereas low-fat diets resulted in reductions in TGs and LDL-C and increases in HDL-C. Results were consistent across malabsorptive and restrictive surgery.

Conclusions: Weight loss in adults is associated with statistically significant changes in serum lipids. The reported magnitude of improvement can help in setting expectations, inform shared decision making, and facilitate counseling.
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http://dx.doi.org/10.1210/clinem/dgaa673DOI Listing
December 2020

Targeted Therapy- and Chemotherapy-Associated Skin Toxicities: Systematic Review and Meta-Analysis.

Oncol Nurs Forum 2020 09;47(5):E149-E160

Mayo Clinic.

Problem Identification: Preventing and managing skin toxicities can minimize treatment disruptions and improve well-being. This systematic review aimed to evaluate the effectiveness of interventions for the prevention and management of cancer treatment-related skin toxicities.

Literature Search: The authors systematically searched for comparative studies published before April 1, 2019. Study selection and appraisal were conducted by pairs of independent reviewers.

Data Evaluation: The random-effects model was used to conduct meta-analysis when appropriate.

Synthesis: 39 studies (6,006 patients) were included; 16 of those provided data for meta-analysis. Prophylactic minocycline reduced the development of all-grade and grade 1 acneform rash in patients who received erlotinib. Prophylaxis with pyridoxine 400 mg in capecitabine-treated patients lowered the risk of grade 2 or 3 hand-foot syndrome. Several treatments for hand-foot skin reaction suggested benefit in heterogeneous studies. Scalp cooling significantly reduced the risk for severe hair loss or total alopecia associated with chemotherapy.

Implications For Research: Certainty in the available evidence was limited for several interventions, suggesting the need for future research.

Supplemental Material Can Be Found At https: //onf.ons.org/supplementary-material-targeted-therapy-and-chemotherapy-associated-skin-toxicity-systematic-review.
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http://dx.doi.org/10.1188/20.ONF.E149-E160DOI Listing
September 2020

Prospective Surveillance and Risk Reduction of Cancer Treatment-Related Lymphedema: Systematic Review and Meta-Analysis.

Oncol Nurs Forum 2020 09;47(5):E161-E170

Mayo Clinic.

Problem Identification: Secondary lymphedema is a chronic condition that may result from cancer-related treatments. Evidence is emerging on prospective surveillance and risk reduction.

Literature Search: Databases were systematically searched through April 1, 2019, for comparative studies evaluating interventions aiming to prevent lymphedema in patients with cancer.

Data Evaluation: A random-effects model was used to perform meta-analysis, when appropriate.

Synthesis: A total of 26 studies (4,095 patients) were included, with 23 providing data sufficient for meta-analysis. Surveillance programs increased the likelihood of detecting lymphedema. Physiotherapy, exercise programs, and delayed exercise reduced the incidence of lymphedema.

Implications For Research: Future research should standardize (a) evidence-based interventions to reduce the development of lymphedema and increase the likelihood of early detection and (b) outcome measures to build a body of evidence that leads to practice change.

Supplemental Material Can Be Found At https: //onf.ons.org/supplementary-material-systematic-review-cancer-treatment-related-lymphedema.
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http://dx.doi.org/10.1188/20.ONF.E161-E170DOI Listing
September 2020

A Framework for Evidence Synthesis Programs to Respond to a Pandemic.

Mayo Clin Proc 2020 07 16;95(7):1426-1429. Epub 2020 Jun 16.

Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN.

The coronavirus disease 2019 (COVID-19) pandemic requires making rapid decisions based on sparse and rapidly changing evidence. Evidence synthesis programs conduct systematic reviews for guideline developers, health systems clinicians, and decision-makers that usually take an average 6 to 8 months to complete. We present a framework for evidence synthesis programs to respond to pandemics that has proven feasible and practical during the COVID-19 response in a large multistate health system employing more than 78,000 people. The framework includes four components: an approach for conducting rapid reviews, a repository of rapid reviews, a registry for all original studies about COVID-19, and twice-weekly prioritized update of new evidence sent to key stakeholders. As COVID-19 will not be our last pandemic, we share the details of this framework to allow replication in other institutions and re-implementation in future pandemics.
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http://dx.doi.org/10.1016/j.mayocp.2020.05.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7833794PMC
July 2020

Cell-based therapy to reduce mortality from COVID-19: Systematic review and meta-analysis of human studies on acute respiratory distress syndrome.

Stem Cells Transl Med 2020 09 29;9(9):1007-1022. Epub 2020 May 29.

Department of Pathology and Laboratory Medicine, Department of Health Policy and Management, Rollins School of Public Health, Emory University, The Marcus Foundation, Atlanta, Georgia, USA.

Severe cases of COVID-19 infection, often leading to death, have been associated with variants of acute respiratory distress syndrome (ARDS). Cell therapy with mesenchymal stromal cells (MSCs) is a potential treatment for COVID-19 ARDS based on preclinical and clinical studies supporting the concept that MSCs modulate the inflammatory and remodeling processes and restore alveolo-capillary barriers. The authors performed a systematic literature review and random-effects meta-analysis to determine the potential value of MSC therapy for treating COVID-19-infected patients with ARDS. Publications in all languages from 1990 to March 31, 2020 were reviewed, yielding 2691 studies, of which nine were included. MSCs were intravenously or intratracheally administered in 117 participants, who were followed for 14 days to 5 years. All MSCs were allogeneic from bone marrow, umbilical cord, menstrual blood, adipose tissue, or unreported sources. Combined mortality showed a favorable trend but did not reach statistical significance. No related serious adverse events were reported and mild adverse events resolved spontaneously. A trend was found of improved radiographic findings, pulmonary function (lung compliance, tidal volumes, PaO /FiO ratio, alveolo-capillary injury), and inflammatory biomarker levels. No comparisons were made between MSCs of different sources.
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http://dx.doi.org/10.1002/sctm.20-0146DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7300743PMC
September 2020

Error rates of human reviewers during abstract screening in systematic reviews.

PLoS One 2020 14;15(1):e0227742. Epub 2020 Jan 14.

Evidence-based Practice Center, Mayo Clinic, Rochester, Minnesota, United States of America.

Background: Automated approaches to improve the efficiency of systematic reviews are greatly needed. When testing any of these approaches, the criterion standard of comparison (gold standard) is usually human reviewers. Yet, human reviewers make errors in inclusion and exclusion of references.

Objectives: To determine citation false inclusion and false exclusion rates during abstract screening by pairs of independent reviewers. These rates can help in designing, testing and implementing automated approaches.

Methods: We identified all systematic reviews conducted between 2010 and 2017 by an evidence-based practice center in the United States. Eligible reviews had to follow standard systematic review procedures with dual independent screening of abstracts and full texts, in which citation inclusion by one reviewer prompted automatic inclusion through the next level of screening. Disagreements between reviewers during full text screening were reconciled via consensus or arbitration by a third reviewer. A false inclusion or exclusion was defined as a decision made by a single reviewer that was inconsistent with the final included list of studies.

Results: We analyzed a total of 139,467 citations that underwent 329,332 inclusion and exclusion decisions from 86 unique reviewers. The final systematic reviews included 5.48% of the potential references identified through bibliographic database search (95% confidence interval (CI): 2.38% to 8.58%). After abstract screening, the total error rate (false inclusion and false exclusion) was 10.76% (95% CI: 7.43% to 14.09%).

Conclusions: This study suggests important false inclusion and exclusion rates by human reviewers. When deciding the validity of a future automated study selection algorithm, it is important to keep in mind that the gold standard is not perfect and that achieving error rates similar to humans may be adequate and can save resources and time.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0227742PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6959565PMC
April 2020

Influence of water based embedding media composition on the relaxation properties of fixed tissue.

Magn Reson Imaging 2020 04 7;67:7-17. Epub 2019 Dec 7.

Department of Biochemistry and Molecular Biology, Mayo Clinic, Rochester, MN 55905, USA. Electronic address:

Background: In MRI of formalin-fixed tissue one of the problems is the dependence of tissue relaxation properties on formalin composition and composition of embedding medium (EM) used for scanning. In this study, we investigated molecular mechanisms by which the EM composition affects T2 relaxation directly and T1 relaxation indirectly.

Objective: To identify principal components of formaldehyde based EM and the mechanism by which they affect relaxation properties of fixed tissue.

Methods: We recorded high resolution H NMR spectra of common formalin fixatives at temperatures in the range of 5 °C to 45 °C. We also measured T1 and T2 relaxation times of various organs of formalin fixed (FF) zebrafish at 7 T at 21 °C and 31 °C in several EM with and without fixative or gadolinium contrast agents.

Results: We showed that the major source of T2 variability is chemical exchange between protons from EM hydroxyls and water, mediated by the presence of phosphate ions. The exchange rate increases with temperature, formaldehyde concentration in EM and phosphate concentration in EM. Depending on which side of the coalescence the system resides, the temperature increase can lead to either shortening or prolongation of T2, or to no noticeable change at all when very close to the coalescence. Chemical exchange can be minimized by washing out from EM the fixative, the phosphate or both.

Conclusion: The dependence of T2 in fixed tissue on the fixative origin and composition described in prior literature could be attributed to the phosphate buffer accelerated chemical exchange among the fixative hydroxyls and the tissue water. More consistent results in the relaxation measurements could be obtained by stricter control of the fixative composition or by scanning fixed tissue in PBS without fixative.
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http://dx.doi.org/10.1016/j.mri.2019.11.019DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7035978PMC
April 2020

IgM Natural Autoantibodies in Physiology and the Treatment of Disease.

Methods Mol Biol 2019 ;1904:53-81

Department of Neurology, Mayo Clinic, Rochester, MN, USA.

Antibodies are vital components of the adaptive immune system for the recognition and response to foreign antigens. However, some antibodies recognize self-antigens in healthy individuals. These autoreactive antibodies may modulate innate immune functions. IgM natural autoantibodies (IgM-NAAs) are a class of primarily polyreactive immunoglobulins encoded by germline V-gene segments which exhibit low affinity but broad specificity to both foreign and self-antigens. Historically, these autoantibodies were closely associated with autoimmune disease. Nevertheless, not all human autoantibodies are pathogenic and compelling evidence indicates that IgM-NAAs may exert a spectrum of effects from injurious to protective depending upon cellular and molecular context. In this chapter, we review the current state of knowledge regarding the potential physiological and therapeutic roles of IgM-NAAs in different disease conditions such as atherosclerosis, cancer, and autoimmune disease. We also describe the discovery of two reparative IgM-NAAs by our laboratory and delineate their proposed mechanisms of action in central nervous system (CNS) disease.
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http://dx.doi.org/10.1007/978-1-4939-8958-4_3DOI Listing
June 2019

Noninvasive Ventilation in Patients With Do-Not-Intubate and Comfort-Measures-Only Orders: A Systematic Review and Meta-Analysis.

Crit Care Med 2018 08;46(8):1209-1216

Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN.

Objectives: To assess the effectiveness of noninvasive ventilation in patients with acute respiratory failure and do-not-intubate or comfort-measures-only orders.

Data Sources: MEDLINE, EMBASE, CINAHL, Scopus, and Web of Science from inception to January 1, 2017.

Study Selection: Studies of all design types that enrolled patients in the ICU or hospital ward who received noninvasive ventilation and had preset do-not-intubate or comfort-measures-only orders.

Data Extraction: Data abstraction followed Meta-analysis of Observational Studies in Epidemiology guidelines. Data quality was assessed using a modified Newcastle-Ottawa Scale.

Data Synthesis: Twenty-seven studies evaluating 2,020 patients with do-not-intubate orders and three studies evaluating 200 patients with comfort-measures-only orders were included. In patients with do-not-intubate orders, the pooled survival was 56% (95% CI, 49-64%) at hospital discharge and 32% (95% CI, 21-45%) at 1 year. Hospital survival was 68% for chronic obstructive pulmonary disease, 68% for pulmonary edema, 41% for pneumonia, and 37% for patients with malignancy. Survival was comparable for patients treated in a hospital ward versus an ICU. Quality of life of survivors was not reduced compared with baseline, although few studies evaluated this. No studies evaluated quality of dying in nonsurvivors. In patients with comfort-measures-only orders, a single study showed that noninvasive ventilation was associated with mild reductions in dyspnea and opioid requirements.

Conclusions: A large proportion of patients with do-not-intubate orders who received noninvasive ventilation survived to hospital discharge and at 1 year, with limited data showing no decrease in quality of life in survivors. Provision of noninvasive ventilation in a well-equipped hospital ward may be a viable alternative to the ICU for selected patients. Crucial questions regarding quality of life in survivors, quality of death in nonsurvivors, and the impact of noninvasive ventilation in patients with comfort-measures-only orders remain largely unanswered.
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http://dx.doi.org/10.1097/CCM.0000000000003082DOI Listing
August 2018
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