Measuring Documentation Burden in Healthcare.

BACKGROUND: The enactment of the Health Information Technology for Economic and Clinical Health Act and the wide adoption of electronic health record (EHR) systems have ushered in increasing documentation burden, frequently cited as a key factor affecting the work experience of healthcare professionals and a contributor to burnout. This systematic review aims to identify and characterize measures of documentation burden. METHODS: We integrated discussions with Key Informants and a comprehensive search of the literature, including MEDLINE, Embase, Scopus, and gray literature published between 2010 and 2023. Data were narratively and thematically synthesized. RESULTS: We identified 135 articles about measuring documentation burden. We classified measures into 11 categories: overall time spent in EHR, activities related to clinical documentation, inbox management, time spent in clinical review, time spent in orders, work outside work/after hours, administrative tasks (billing and insurance related), fragmentation of workflow, measures of efficiency, EHR activity rate, and usability. The most common source of data for most measures was EHR usage logs. Direct tracking such as through time-motion analysis was fairly uncommon. Measures were developed and applied across various settings and populations, with physicians and nurses in the USA being the most frequently represented healthcare professionals. Evidence of validity of these measures was limited and incomplete. Data on the appropriateness of measures in terms of scalability, feasibility, or equity across various contexts were limited. The physician perspective was the most robustly captured and prominently focused on increased stress and burnout. DISCUSSION: Numerous measures for documentation burden are available and have been tested in a variety of settings and contexts. However, most are one-dimensional, do not capture various domains of this construct, and lack robust validity evidence. This report serves as a call to action highlighting an urgent need for measure development that represents diverse clinical contexts and support future interventions.

Meditation for perioperative pain and anxiety: A systematic review.

INTRODUCTION: Effective pain and anxiety management during the perioperative phase remains a challenge for patients undergoing surgeries and other invasive procedures. The current standard of care involves prescribing analgesics to treat these conditions; however, there has been recent interest in applying multimodal strategies that limit the use of these medications. One such modality is meditation, which has been shown to be effective in alleviating various physical and psychological symptoms in other settings. This systematic review aims to assess how current meditative practices affect perioperative pain and anxiety. METHODS: We conducted a systematic review of randomized controlled trials following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A comprehensive literature search was conducted using PubMed MEDLINE, Embase, PsycINFO, APA PsycINFO, EBM Reviews, Scopus, and Web of Science for all available dates. Our primary outcomes of interest were patient-reported pain and anxiety scores using the Visual Analog Scale, the Brief Pain Inventory, the Depression Anxiety Stress Scale, the State-Trait Anxiety Inventory (STAI), and the Hospital Anxiety and Depression Scale (HADS). For the HADS and STAI scales, only the anxiety and anxiety-state subgroups were reported, respectively. RESULTS: The literature search yielded 1746 articles. A total of 286 full-text articles were screened, and 16 studies were included in this systematic review. A total of eight studies assessed pain scores after invasive procedures; five reported improvements in pain scores, and three reported no change after meditative practices. Ten studies assessed anxiety outcomes after invasive procedures: nine reported a decrease in overall anxiety levels as a result of meditation practices while one study reported no change in anxiety scores. CONCLUSION: Data from this limited literature suggests that different meditation practices could be effective in alleviating pain and anxiety within the perioperative phase for patients undergoing various types of invasive procedures. Future prospective studies are needed to determine whether routine meditation in the perioperative setting is effective in mitigating perioperative pain and anxiety.

A Systematic Review Supporting the Endocrine Society Clinical Practice Guidelines on Vitamin D.

CONTEXT: Low vitamin D status is common and is associated with various common medical conditions. OBJECTIVE: To support the development of the Endocrine Society's Clinical Practice Guideline on Vitamin D for the Prevention of Disease. METHODS: We searched multiple databases for studies that addressed 14 clinical questions prioritized by the guideline panel. Of the 14 questions, 10 clinical questions assessed the effect of vitamin D vs no vitamin D in the general population throughout the lifespan, during pregnancy, and in adults with prediabetes; 1 question assessed dosing; and 3 questions addressed screening with serum 25-hydroxyvitamin D (25[OH]D). The Grading of Recommendations Assessment, Development and Evaluation approach was used to assess certainty of evidence. RESULTS: Electronic searches yielded 37 007 citations, from which we included 151 studies. In children and adolescents, low-certainty evidence suggested reduction in respiratory tract infections with empiric vitamin D. There was no significant effect on select outcomes in healthy adults aged 19 to 74 years with variable certainty of evidence. There was a very small reduction in mortality among adults older than 75 years with high certainty of evidence. In pregnant women, low-certainty evidence suggested possible benefit on various maternal, fetal, and neonatal outcomes. In adults with prediabetes, moderate certainty of evidence suggested reduction in the rate of progression to diabetes. Administration of high-dose intermittent vitamin D may increase falls, compared to lower-dose daily dosing. We did not identify trials on the benefits and harms of screening with serum 25(OH)D. CONCLUSION: The evidence summarized in this systematic review addresses the benefits and harms of vitamin D for the prevention of disease. The guideline panel considered additional information about individuals' and providers' values and preferences and other important decisional and contextual factors to develop clinical recommendations.

Imaging-based non-invasive liver disease assessment for staging liver fibrosis in chronic liver disease: A systematic review supporting the AASLD Practice Guideline.

BACKGROUND AND AIMS: Transient elastography (TE), shear-wave elastography (SWE), and/or magnetic resonance elastography (MRE), each providing liver stiffness measurement (LSM), are the most studied imaging-based noninvasive liver disease assessment (NILDA) techniques. To support the American Association for the Study of Liver Diseases guidelines on NILDA, we summarized the evidence on the accuracy of these LSM methods to stage liver fibrosis (F). APPROACH AND RESULTS: A comprehensive search for studies assessing LSM by TE, SWE, or MRE for the identification of significant fibrosis (F2-4), advanced fibrosis (F3-4), or cirrhosis (F4), utilizing histopathology as standard of reference by liver disease etiology in adults or children from inception to April 2022 was performed. We excluded studies with <50 patients with a single disease entity and mixed liver disease etiologies (with the exception of HCV/HIV co-infection). Out of 9447 studies, 240 with 61,193 patients were included in this systematic review. In adults, sensitivities for the identification of F2-4 ranged from 51% to 95%, for F3-4 from 70% to 100%, and for F4 from 60% to 100% across all techniques/diseases, whereas specificities ranged from 36% to 100%, 74% to 100%, and 67% to 99%, respectively. The largest body of evidence available was for TE; MRE appeared to be the most accurate method. Imaging-based NILDA outperformed blood-based NILDA in most comparisons, particularly for the identification of F3-4/F4. In the pediatric population, imaging-based NILDA is likely as accurate as in adults. CONCLUSION: LSM from TE, SWE, and MRE show acceptable to outstanding accuracy for the detection of liver fibrosis across various liver disease etiologies. Accuracy increased from F2-4 to F3-4 and was the highest for F4. Further research is needed to better standardize the use of imaging-based NILDA, particularly in pediatric liver diseases.

Accuracy of blood-based biomarkers for staging liver fibrosis in chronic liver disease: A systematic review supporting the AASLD Practice Guideline.

BACKGROUND AND AIMS: Blood-based biomarkers have been proposed as an alternative to liver biopsy for non-invasive liver disease assessment (NILDA) in chronic liver disease (CLD). Our aims for this systematic review were to evaluate the diagnostic utility of selected blood-based tests either alone, or in combination, for identifying significant fibrosis (F2-4), advanced fibrosis (F3-4) and cirrhosis (F4), as compared to biopsy in CLD. APPROACH AND RESULTS: We included a comprehensive search of databases including Ovid MEDLINE(R), EMBASE, Cochrane Database, and Scopus through to April 2022. Two independent reviewers selected 286 studies with 103,162 patients. The most frequently identified studies included the simple aminotransferase-to-platelet ratio index (APRI) and fibrosis (FIB)-4 markers (with low-to-moderate risk of bias) in hepatitis B virus (HBV) and C virus (HCV), HIV-HCV/HBV co-infection, and nonalcoholic fatty liver disease (NAFLD). Positive (LR+) and negative (LR) likelihood ratios across direct and indirect biomarker tests for HCV and HBV for F2-4, F3-4, or F4 were 1.66-6.25 and 0.23-0.80, 1.89-5.24 and 0.12-0.64, and 1.32-7.15 and 0.15-0.86 respectively; LR+ and LR for NAFLD F2-4, F3-4 and F4 were 2-65-3.37 and 0.37-0.39, 2.25-6.76 and 0.07-0.87, and 3.90 and 0.15 respectively. Overall, proportional odds ratio indicated FIB-4 <1.45 was better than APRI <0.5 for F2-4. FIB-4 >3.25 was also better than APRI >1.5 for F3-4 and F4. There was limited data for combined tests. CONCLUSIONS: Blood-based biomarkers are associated with small-to-moderate change in pre-test probability for diagnosing F2-4, F3-4, and F4 in viral hepatitis, HIV-HCV co-infection, and NAFLD, with limited comparative or combination studies for other CLD.

Non-invasive liver disease assessment to identify portal hypertension: A systematic review supporting the AASLD Practice Guideline.

INTRODUCTION: Portal hypertension is a serious complication of cirrhosis, which leads to life-threatening complications. Hepatic venous pressure gradient (HVPG), a surrogate of portal pressure, is the reference standard test to assess the severity of portal hypertension. However, since HVPG is limited by its invasiveness and by its availability, non-invasive liver disease assessments (NILDAs) to assess portal pressure, especially clinically significant portal hypertension (CSPH), are needed. METHODS: We conducted a systematic review of Ovid MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, and Daily, Ovid EMBASE, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, and Scopus from each database's inception to April 22 nd , 2022. We included only studies in English that examined ≥50 patients in single liver disease etiologies which compared non-invasive tests (blood, and/or imaging) to HVPG for predicting clinically significant portal hypertension (CSPH; defined as HVPG ≥10 mm Hg) in patients with chronic liver disease (this therefore limited the number of studies that could be included). Outcomes reported included measures of diagnostic test accuracy. Additionally, a narrative review of studies not eligible for the systematic review is also provided. RESULTS: Nine studies with 2,492 patients met the inclusion criteria. There was substantial heterogeneity with regard to liver disease studied and cutoff values used to detect CSPH. Blood based tests, including aspartate to platelet ratio index (APRI) (56% sensitivity and 68% specificity) and fibrosis-4 (FIB-4) (54% sensitivity and 73% specificity) had low accuracy measures. Imaging based tests (transient elastography (TE) and shear wave elastography detection of liver stiffness (LSM)) had better accuracy, but also had substantial variation; at 15 kPa, TE sensitivity was 90%-96% and specificity was 48%-50% while at 25 kPa, its sensitivity and specificity were 57%-85% and 82%-93%, respectively. The narrative review suggested that imaging based tests are the best available NILDA to detect CSPH, CSPH is highly unlikely to be present at an LSM ≤15 kPa and likely to be present at an LSM ≥25 kPa. CONCLUSION: While imaging-based NILDA appeared to have higher accuracy than blood-based tests to detect CSPH, only 9 studies fit the a priori established inclusion criteria for the SR. In addition, there was substantial study heterogeneity and variation in cutoffs for LSM to detect CSPH, limiting the ability to establish definitive cutoffs to detect CSPH.

Integrating large language models in systematic reviews: a framework and case study using ROBINS-I for risk of bias assessment.

Large language models (LLMs) may facilitate and expedite systematic reviews, although the approach to integrate LLMs in the review process is unclear. This study evaluates GPT-4 agreement with human reviewers in assessing the risk of bias using the Risk Of Bias In Non-randomised Studies of Interventions (ROBINS-I) tool and proposes a framework for integrating LLMs into systematic reviews. The case study demonstrated that raw per cent agreement was the highest for the ROBINS-I domain of 'Classification of Intervention'. Kendall agreement coefficient was highest for the domains of 'Participant Selection', 'Missing Data' and 'Measurement of Outcomes', suggesting moderate agreement in these domains. Raw agreement about the overall risk of bias across domains was 61% (Kendall coefficient=0.35). The proposed framework for integrating LLMs into systematic reviews consists of four domains: rationale for LLM use, protocol (task definition, model selection, prompt engineering, data entry methods, human role and success metrics), execution (iterative revisions to the protocol) and reporting. We identify five basic task types relevant to systematic reviews: selection, extraction, judgement, analysis and narration. Considering the agreement level with a human reviewer in the case study, pairing artificial intelligence with an independent human reviewer remains required.

Health-Related Factors Among Pilots in Aviation Accidents.

INTRODUCTION: Health-related factors can impact aviation safety. This study investigated the published, historical aviation accidents that have been investigated by the U.S. National Transportation Safety Board (NTSB) to understand medical conditions and medication use that have been determined to be causal to mishaps.METHODS: A two-part approach was adopted for this study: 1) a scoping review was conducted to provide an overview of the current medical literature addressing medical factors and flight safety; and 2) a comprehensive review of aviation accident reports from the NTSB database from January 2013 to October 2022.RESULTS: The literature review demonstrated that psychiatric, cardiovascular, and neurological medications were the major categories of medications reported in fatal aircraft accidents. Age was not found to be a risk factor. Review of the NTSB database demonstrated that, among 15,654 mishaps, medical factors were associated in 703 (4.5%) accidents. NTSB data showed that cardiovascular (1.3%), psychiatric (0.23%), and endocrine diseases (0.17%) were the most commonly reported diseases among pilots. In accident reports, cardiovascular medications (1.49%), sedating antihistamines (0.91%), and alcohol (0.70%) were the most commonly used medications at the time of the accidents.DISCUSSION: Health-related factors were a small yet likely underestimated proportion of the factors associated with accidents. Cardiovascular diseases and treatment were the most important factors. It is important to continue to investigate the association between health-related factors and the commission of mishaps.Zhu Y, Wolf ME, Alsibai RA, Abbas AS, Alsawaf Y, Saadi S, Farah MH, Wang Z, Murad MH. Health-related factors among pilots in aviation accidents. Aerosp Med Hum Perform. 2024; 95(2):79-83.

Partial breast irradiation compared with whole breast irradiation: a systematic review and meta-analysis.

BACKGROUND: Early-stage breast cancer is among the most common cancer diagnoses. Adjuvant radiotherapy is an essential component of breast-conserving therapy, and several options exist for tailoring its extent and duration. This study assesses the comparative effectiveness of partial-breast irradiation (PBI) compared with whole-breast irradiation (WBI). METHODS: A systematic review was completed to identify relevant randomized clinical trials and comparative observational studies. Independent reviewers working in pairs selected studies and extracted data. Randomized trial results were pooled using a random effects model. Prespecified main outcomes were ipsilateral breast recurrence (IBR), cosmesis, and adverse events (AEs). RESULTS: Fourteen randomized clinical trials and 6 comparative observational studies with 17 234 patients evaluated the comparative effectiveness of PBI. PBI was not statistically significantly different from WBI for IBR at 5 years (RR = 1.34, 95% CI = 0.83 to 2.18; high strength of evidence [SOE]) and 10 years (RR = 1.29, 95% CI = 0.87 to 1.91; high SOE). Evidence for cosmetic outcomes was insufficient. Statistically significantly fewer acute AEs were reported with PBI compared with WBI, with no statistically significant difference in late AEs. Data from subgroups according to patient, tumor, and treatment characteristics were insufficient. Intraoperative radiotherapy was associated with higher IBR at 5, 10, and over than 10 years (high SOE) compared with WBI. CONCLUSIONS: Ipsilateral breast recurrence was not statistically significantly different between PBI and WBI. Acute AEs were less frequent with PBI. This evidence supports the effectiveness of PBI among selected patients with early-stage, favorable-risk breast cancer who are similar to those represented in the included studies.

A systematic review supporting the Society for Vascular Surgery guidelines on the management of heritable aortopathies.

BACKGROUND: To support the development of clinical practice guidelines on the management of patients with genetic aortopathies and arteriopathies, a writing committee from the Society for Vascular Surgery has commissioned this systematic review. METHODS: We conducted a systematic review and searched multiple databases for studies addressing six questions identified by the Society for Vascular Surgery guideline committee about evaluating and managing patients with genetic aortopathies and arteriopathies. Studies were selected and appraised by pairs of independent reviewers. RESULTS: We included 12 studies in this systematic review. We did not identify studies about the long-term outcomes of endovascular repair for aortic aneurysm in patients with heritable aortopathy or about new aortic events in pregnant women with a history of aortic dissection (AD) or aneurysm. A small case series demonstrated a 100% survival rate and 100% aortic intervention-free survival at 15 months (range, 7-28 months) after endograft repair for type B AD. A positive genetic diagnosis was discovered in 36% of patients with aortic aneurysms and dissections who had no risk factors for hereditary aortopathies, and these patients had a mortality rate of 11% at a median follow-up duration of 5 months. Black patients had lower 30-day mortality than White patients (5.6% vs 9.0%, respectively), but they had a higher overall aortic reintervention rate at 30 days after AD repair (47% vs 27%, respectively). Aortic reinterventions owing to aneurysmal expansion and endoleak at 30 days were higher in Black patients than White patients. The certainty of evidence was judged to be very low across all the outcomes evaluated in this systematic review. CONCLUSIONS: The available evidence suggests high survival after thoracic endovascular aortic repair for type B AD in young patients with heritable aortopathies, but with limited long-term follow-up. Genetic testing in patients with acute aortic aneurysms and dissections had a high yield. It was positive for most patients with risk factors for hereditary aortopathies and in more than one-third for all other patients, and was associated with new aortic events within 15 years.

Lack of patient-centered evaluation of outcomes in intermittent claudication literature.

BACKGROUND: Peripheral arterial disease, characterized as arterial atherosclerotic disease, can lead to insufficient flow in the lower extremities and ischemia, with the most common clinical manifestation being intermittent claudication (IC). In 2022, the Society for Vascular Surgery (SVS) developed appropriate use criteria for the management of IC that used this systematic review as a source of evidence. The objective of this study is to synthesize the findings of the systematic review and identify evidence gaps. METHODS: A comprehensive search of literature databases including MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Scopus was conducted from January 1, 2000, to November 30, 2022. Noncomparative and comparative observational studies and randomized controlled trials were included. Included studies evaluated exercise therapy, endovascular or open revascularization for the treatment of IC. Outcomes of interest (freedom from major adverse limb event, health-related quality of life, and walking distance) were compared in various subgroups (age, sex, diabetes, smoking status, anatomical location of disease, and optimal medical therapy). RESULTS: Twenty-six studies reported the outcomes of interest for the evidence map. The general conclusions of the studies that reported freedom from major adverse limb events were that reintervention rates for endovascular therapy at ≥2 years were >20%, major amputation rates were often not reported, and, after endovascular therapy, the 1-month mortality was low (<2%). Quality of life and walking distance data were sparse, limited to only endovascular intervention, and insufficient to make any strong conclusions. CONCLUSIONS: IC in patients with peripheral arterial disease poses a significant socioeconomic and health care burden. Major, consequential gaps exist in the IC literature with respect to the assessment of patient reported outcome measures, standardized measures of walking distance and the comparative effectiveness of initial exercise therapy vs invasive intervention. The evidence gaps identified by the Society for Vascular Surgery appropriate use criteria on IC systematic review serve as a guide for future research efforts to optimize care for this patient population.

Predictors of Mortality in Patients With Refractory Cardiac Arrest Supported With VA-ECMO: A Systematic Review and a Meta-Analysis.

Cardiac arrest (CA) is associated with high mortality rate, ranging between 75% and 93%. Given its significance, venoarterial extracorporeal membrane oxygenation (VA-ECMO) has been used for end-organs perfusion and to maintain adequate oxygenation as a life-saving option in refractory CA. The predictors for the success of VA-ECMO in this setting have not been established yet. In this meta-analysis, we aim to identify the variables associated with increased mortality in patients with CA supported with VA-ECMO. We conducted a systematic review and meta-analysis to evaluate mortality-predicting factors in patients with CA supported with VA-ECMO that were published between January 2000 and July 2022. To identify relevant articles, the MEDLINE (Pubmed, Ovid) and Cochrane Databases were queried with various combinations of our prespecified keywords, including VA-ECMO, CA, and mortality predictors. We performed a meta-analysis using a random-effects model to calculate the odds ratio (OR). We retrieved a total of 4476 records, out of which we included 10 observational studies in our study. A total of 931 patients were included in our study with the age range of 47-68 years, predominantly males (63.9%). The overall mortality was 69.4%. The predictors for mortality were age >65 (OR 4.61, 95% CI 1.63-13.03, P < 0.01), history of chronic kidney disease (OR 2.42, 95% CI 1.37-4.28, P < 0.01), cardiopulmonary resuscitation duration prior to ECMO > 40 minutes (OR 6.62 [95% CI 1.39, 9.02], P < 0.01), having an initial nonshockable rhythm (OR 2.62 [95% CI 1.85, 3.70], P < 0.01) and sequential organ failure assessment score >14 (OR 12.29, 95% CI 2.71-55.74, P <0.01). Regarding blood work, an increase in lactate by 5 mmol/L increased the odds of mortality by 121% (2 studies; OR 2.21 [95% CI 1.26, 3.86], P < 0.01; I2 = 0%) while the increase in lactate by 1 mmol/L increases odd of mortality by 15% (2 studies, OR 1.15 [95% CI 1.02, 1.31], P = 0.03, I = 0%), and an increase in creatinine by 1 mg/dL increased the odds of mortality by 225% (1 study; OR 3.25 [95% CI 1.22, 8.7], P = 0.02). Albumin was protective as for each 1 g/dL increase, the odds of mortality decreased by 68% (1 study; OR 0.32 [95% CI 0.14, 0.74], P < 0.01). Refractory CA requiring VA-ECMO has a high mortality. Predictors of mortality include age >65, history of chronic kidney disease, cardiopulmonary resuscitation duration prior to ECMO > 40 minutes, initial rhythm being non-shockable and Sequential Organ Failure Assessment score >14.

A Systematic Review Supporting the Endocrine Society Clinical Practice Guideline on the Treatment of Hypercalcemia of Malignancy in Adults.

CONTEXT: Hypercalcemia is a common complication of malignancy that is associated with high morbidity and mortality. OBJECTIVE: To support development of the Endocrine Society Clinical Practice Guideline for the treatment of hypercalcemia of malignancy in adults. METHODS: We searched multiple databases for studies that addressed 8 clinical questions prioritized by a guideline panel from the Endocrine Society. Quantitative and qualitative synthesis was performed. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess certainty of evidence. RESULTS: We reviewed 1949 citations, from which we included 21 studies. The risk of bias for most of the included studies was moderate. A higher proportion of patients who received bisphosphonate achieved resolution of hypercalcemia when compared to placebo. The incidence rate of adverse events was significantly higher in the bisphosphonate group. Comparing denosumab to bisphosphonate, there was no significant difference in the rate of patients who achieved resolution of hypercalcemia. Two-thirds of patients with refractory/recurrent hypercalcemia of malignancy who received denosumab following bisphosphonate therapy achieved resolution of hypercalcemia. Addition of calcitonin to bisphosphonate therapy did not affect the resolution of hypercalcemia, time to normocalcemia, or hypocalcemia. Only indirect evidence was available to address questions on the management of hypercalcemia in tumors associated with high calcitriol levels, refractory/recurrent hypercalcemia of malignancy following the use of bisphosphonates, and the use of calcimimetics in the treatment of hypercalcemia associated with parathyroid carcinoma. The certainty of the evidence to address all 8 clinical questions was low to very low. CONCLUSION: The evidence summarized in this systematic review addresses the benefits and harms of treatments of hypercalcemia of malignancy. Additional information about patients' values and preferences, and other important decisional and contextual factors is needed to facilitate the development of clinical recommendations.

Perioperative Management of Vitamin K Antagonists and Direct Oral Anticoagulants: A Systematic Review and Meta-analysis.

BACKGROUND: The management of patients who are receiving chronic oral anticoagulation therapy and require an elective surgery or an invasive procedure is a common clinical scenario. RESEARCH QUESTION: What is the best available evidence to support the development of American College of Chest Physicians guidelines on the perioperative management of patients who are receiving long-term vitamin K agonist (VKA) or direct oral anticoagulant (DOAC) and require elective surgery or procedures? STUDY DESIGN AND METHODS: A literature search including multiple databases from database inception through July 16, 2020, was performed. Meta-analyses were conducted when appropriate. RESULTS: In patients receiving VKA (warfarin) undergoing elective noncardiac surgery, shorter (< 3 days) VKA interruption is associated with an increased risk of major bleeding. In patients who required VKA interruption, heparin bridging (mostly with low-molecular-weight heparin [LMWH]) was associated with a statistically significant increased risk of major bleed, representing a very low certainty of evidence (COE). Compared with DOAC interruption 1 to 4 days before surgery, continuing DOACs may be associated with higher risk of bleeding demonstrated in some, but not all studies. In patients who needed DOAC interruption, bridging with LMWH may be associated with a statistically significant increased risk of bleeding, representing a low COE. INTERPRETATION: The certainty in the evidence supporting the perioperative management of anticoagulants remains limited. No high-quality evidence exists to support the practice of heparin bridging during the interruption of VKA or DOAC therapy for an elective surgery or procedure, or for the practice of interrupting VKA therapy for minor procedures, including cardiac device implantation, or continuation of a DOAC vs short-term interruption of a DOAC in the perioperative period.

Thresholds for interpreting the fragility index derived from sample of randomised controlled trials in cardiology: a meta-epidemiologic study.

The fragility index (FI) was proposed as a simplified way to communicate robustness of statistically significant results and their susceptibility to a change of a handful number of events. While this index is intuitive, it is not anchored by a cut-off or a guide for interpretation. We identified cardiovascular trials published in six high impact journals from 2007 to 2021 (500 or more participants and a dichotomous statistically significant primary outcome). We estimated area under curve (AUC) to determine FI value that best predicts whether the treatment effect was precise, defined as adequately powered for a plausible relative risk reduction (RRR) of 25% or 30% or having a CI that is sufficiently narrow to exclude a risk reduction that is too small (close to the null, <0.05). The median FI of 201 included cardiovascular trials was 13 (range 1-172). FI exceeded the number of patients lost to follow-up in 46/201 (22.89%) trials. FI values of 19 and 22 predicted that trials would be precise (powered for RRR of 30% and 25%; respectively, combined with CI that excluded risk reduction <0.05). AUC for meeting these precision criteria was 0.90 (0.86-0.94). In conclusion, FI values that range 19-22 may meet various definitions of precision and can be used as a rule of thumb to suggest that a treatment effect is likely precise and less susceptible to random error. The number of patients lost to follow-up should be presented alongside FI to better illustrate fragility.

Perioperative Management of Antiplatelet Therapy: A Systematic Review and Meta-analysis.

Objective: To summarize the available evidence about the perioperative management of patients who are receiving long-term antiplatelet therapy and require elective surgery/procedures. Methods: This systematic review supports the development of the American College of Chest Physicians guideline on the perioperative management of antiplatelet therapy. A literature search of MEDLINE, EMBASE, Scopus and Cochrane databases was conducted from each database's inception to July 16, 2020. Meta-analyses were conducted when possible. Results: In patients receiving long-term antiplatelet therapy and undergoing elective noncardiac surgery, the available evidence did not show a significant difference in major bleeding between a shorter vs longer antiplatelet interruption, with low certainty of evidence (COE). Compared with patients who received placebo perioperatively, aspirin continuation was associated with increased risk of major bleeding (relative risk [RR], 1.31; 95% CI, 1.15-1.50; high COE) and lower risk of major thromboembolism (RR, 0.74; 95% CI, 0.58-0.94; moderate COE). During antiplatelet interruption, bridging with low-molecular-weight heparin was associated with increased risk of major bleeding compared with no bridging (RR, 1.86; 95% CI, 1.24-2.79; very low COE). Continuation of antiplatelets during minor dental and ophthalmologic procedures was not associated with a statistically significant difference in the risk of major bleeding (very low COE). Conclusion: This systematic review summarizes the current evidence about the perioperative management of antiplatelet therapy and highlights the urgent need for further research, particularly with the increasing prevalence of patients taking 1 or more antiplatelet agents.

A Systematic Review Supporting the Endocrine Society Clinical Practice Guideline for the Management of Hyperglycemia in Adults Hospitalized for Noncritical Illness or Undergoing Elective Surgical Procedures.

CONTEXT: Individuals with diabetes or newly recognized hyperglycemia account for over 30% of noncritically ill hospitalized patients. Management of hyperglycemia in these patients is challenging. OBJECTIVE: To support development of the Endocrine Society Clinical Practice Guideline for management of hyperglycemia in adults hospitalized for noncritical illness or undergoing elective surgical procedures. METHODS: We searched several databases for studies addressing 10 questions provided by a guideline panel from the Endocrine Society. Meta-analysis was conducted when feasible. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess certainty of evidence. RESULTS: We included 94 studies reporting on 135 553 patients. Compared with capillary blood glucose, continuous glucose monitoring increased the number of patients identified with hypoglycemia and decreased mean daily blood glucose (BG) (very low certainty). Data on continuation of insulin pump therapy in hospitalized adults were sparse. In hospitalized patients receiving glucocorticoids, combination neutral protamine hagedorn (NPH) and basal-bolus insulin was associated with lower mean BG compared to basal-bolus insulin alone (very low certainty). Data on NPH insulin vs basal-bolus insulin in hospitalized adults receiving enteral nutrition were inconclusive. Inpatient diabetes education was associated with lower HbA1c at 3 and 6 months after discharge (moderate certainty) and reduced hospital readmissions (very low certainty). Preoperative HbA1c level < 7% was associated with shorter length of stay, lower postoperative BG and a lower number of neurological complications and infections, but a higher number of reoperations (very low certainty). Treatment with glucagon-like peptide-1 agonists or dipeptidyl peptidase-4 inhibitors in hospitalized patients with type 2 diabetes and mild hyperglycemia was associated with lower frequency of hypoglycemic events than insulin therapy (low certainty). Caloric oral fluids before surgery in adults with diabetes undergoing surgical procedures did not affect outcomes (very low certainty). Counting carbohydrates for prandial insulin dosing did not affect outcomes (very low certainty). Compared with scheduled insulin (basal-bolus or basal insulin + correctional insulin), correctional insulin was associated with higher mean daily BG and fewer hypoglycemic events (low certainty). CONCLUSION: The certainty of evidence supporting many hyperglycemia management decisions is low, emphasizing importance of shared decision-making and consideration of other decisional factors.