US Guideline Research Articles

Breast Cancer Risk Assessment Tool (BCRAT) and long-term breast cancer mortality in the Women's Health Initiative.

While the Breast Cancer Risk Assessment Tool (BCRAT) predicts breast cancer incidence, the model's performance, re-purposed to predict breast cancer mortality, is uncertain. Therefore, we examined whether the BCRAT model predicts breast cancer mortality in postmenopausal women in the Women's Health Initiative (WHI). BCRAT 5-year breast cancer incidence risk estimates were calculated for 145,408 women (aged 50-79years) enrolled in the WHI at 40 US clinical centers to examine associations of BCRAT risk groups (< 1%, 1-< 3%, ≥ 3%) with breast cancer mortality using Cox proportional regression modeling in all participants and in those with incident breast cancer. Women with BCRAT ≥ 3% risk, compared to women with BCRAT < 1% risk, were older (age 70-79years: 38.3% versus 5.3%), less commonly Black (1.1% versus 40.2%), and had stronger breast cancer family history. With 20-years follow-up, considering all participants, with 8,849 breast cancers and 1,076 breast cancer deaths, breast cancer mortality in BCRAT group ≥ 3% was not higher versus BCRAT group < 1% (Hazard Ratio [HR] 1.06 95% Confidence Interval [CI] 0.80-1.40): percent without 20-year breast cancer mortality; 99.4% [group < 1%] and 98.8% [group ≥ 3%]. Considering women with incident breast cancer, breast cancer mortality was also not higher in BCRAT group ≥ 3% versus BCRAT group < 1% (HR 1.07 95% CI 0.79-1.45). The BCRAT model, at ≥ 3% 5-year incidence risk (US guideline threshold for chemoprevention), does not identify women with higher breast cancer mortality risk, with implications for breast cancer prevention strategies.

Opioid use surrounding diagnosis and follow-up in patients with ankylosing spondylitis, psoriatic arthritis, and rheumatoid arthritis: Results from US claims databases

ObjectiveTo describe patients’ use of opioids in the year preceding and year following new diagnosis of ankylosing spondylitis (AS), psoriatic arthritis (PsA), or rheumatoid arthritis (RA), compared with patients without the/se diseases.MethodsThis study used US IBM® MarketScan® Commercial Claims and Encounters (CCAE) and Medicaid data and included three cohorts, comprised of incident cases of AS, PsA, or RA (2010–2017). Three matched comparator patients (without the incident disease) were selected for each patient within the disease cohort. Opioid use and appropriate treatment exposure (as defined by US guideline recommendations) in the 12-month baseline and follow-up periods were evaluated using descriptive analyses.ResultsPrevalence of claims for opioids was higher for disease cohorts vs. comparators in CCAE; 36.4% of patients with AS, 29.5% with PsA, and 44.4% with RA did not have any claim for guideline-appropriate therapy in follow-up. Prevalence of claims for opioids was also higher for disease cohorts vs. comparators in Medicaid; 30.6% of patients with AS, 36.6% with PsA, and 65.4% with RA did not have any claim for guideline-appropriate therapy in follow-up.ConclusionsIn patients with AS, PsA, or RA, there was high reliance on opioids at and around the time of diagnosis. Significant proportions of patients were not on appropriate treatment as defined by professional society post-diagnosis guidelines; this discordance between actual patient therapies and treatment recommendations may suggest a need for better awareness of appropriate pain management and treatment strategies in rheumatic diseases.Key Points• This study analysed opioid use among patients with ankylosing spondylitis (AS), psoriatic arthritis (PsA), or rheumatoid arthritis (RA), and adds to current knowledge by expanding beyond assessment of opioid use at diagnosis, to the year before and after diagnosis.• Opioid use was found to be highly prevalent in AS, PsA, and RA in the year prior to diagnosis and, interestingly, was still seen during the year after diagnosis.• Opioids are neither disease modifying, nor a targeted/recommended treatment for chronic autoimmune diseases. In addition to their association with significant economic costs, opioids are potentially hazardous and are not better than alternative treatments with superior safety profiles.• The reasons behind opioid prescribing patterns should be explored further to support movement to targeted therapies.

Ketamine for Adults With Treatment-Resistant Depression or Posttraumatic Stress Disorder: A 2023 Update

What Is the Issue?&#x0D; &#x0D; Many drug treatments are available for depression, but 22% of people in Canada with the condition have treatment-resistant depression (TRD). For people with TRD, standard drug treatments do not improve their symptoms or do not work for long, and their depression persists.&#x0D; Posttraumatic stress disorder (PTSD) is a disabling mental health condition that affects about 9% of people in Canada in their lifetime. Few drugs are available for treating PTSD, none of which are considered effective.&#x0D; Ketamine is a hallucinogenic drug used primarily for anesthesia. Ketamine has also been explored for other indications, such as TRD and PTSD, generating questions about whether it could be a treatment option for these conditions.&#x0D; &#x0D; What Did We Do?&#x0D; &#x0D; We conducted a review of the clinical effectiveness, cost-effectiveness, and evidence-based guidelines on the use of ketamine in adults with TRD or PTSD, to help guide decisions on the use of ketamine for managing these conditions.&#x0D; An information specialist conducted a search of peer-reviewed and grey literature sources published in March 2022 or later. One reviewer screened citations and selected and critically appraised the included studies.&#x0D; CADTH engaged a patient with lived experience of TRD who shared their experiences and perspectives on ketamine-assisted psychotherapy. These perspectives helped us to contextualize the literature and appreciate nuances of the experience.&#x0D; &#x0D; What Did We Find?&#x0D; &#x0D; Ketamine could lead to an immediate improvement in depressive symptoms and suicidal ideation compared to placebo or midazolam in adults with TRD. The longest follow-up was 90 days, and the longest lasting effect after a dose was 28 days. Serious side effects of ketamine — such as dissociation — were rare and short-lived, lasting hours, in adults with TRD.&#x0D; It is uncertain if ketamine is an effective and safe treatment for symptoms of PTSD, due to little to no evidence suggesting its effectiveness or safety against placebo, midazolam, or opioids.&#x0D; Most studies evaluated ketamine given intravenously, and we found limited evidence on intramuscular (IM), subcutaneous, and intranasal routes of administration. We found no studies on oral or sublingual administration of ketamine and no studies comparing the different ways that ketamine can be given for TRD or PTSD.&#x0D; An economic evaluation found that IV ketamine was likely to be cost-effective compared to intranasal esketamine in adults with TRD from a health care perspective in the US. However, from a patient perspective, IV ketamine was unlikely to be cost-effective compared to esketamine, due to comparable levels of clinical effectiveness and lower costs of esketamine attributable to commercial insurance coverage and manufacturer assistance programs.&#x0D; A US guideline on TRD suggests ketamine as augmentation to antidepressants. A US guideline on PTSD does not suggest the use of ketamine as therapy.&#x0D; The patient contributor CADTH engaged for this review highlighted the benefits, stigma, and barriers of ketamine therapy, including financial implications.&#x0D; &#x0D; What Does This Mean?&#x0D; &#x0D; There is some clinical effectiveness and cost-effectiveness evidence and a guideline recommendation to support the short-term use of ketamine in adults with TRD.&#x0D; Clinical effectiveness evidence and a guideline recommendation do not support the use of ketamine in adults with PTSD.&#x0D; Future research is necessary to understand the effectiveness and safety of ketamine as therapy for TRD in larger populations over longer periods and for PTSD for any follow-up duration.&#x0D; Decision-makers should consider offering ketamine in an equitable manner.&#x0D;

Abstract 278: Patterns of Mechanical Thrombectomy for Stroke Before and After the 2015 Pivotal Trials:5 Years Follow‐up

Introduction The 2015 American Heart Association Guidelines recommended mechanical thrombectomy with stent‐retriever devices. A prior published analysis of national trends after one year in mechanical thrombectomy use and outcomes for stroke before and after publication of the 2015 US guideline update showed improved functional outcomes and lower peri‐procedural mortality. We analyze the national trends in mechanical thrombectomy use and outcomes for stroke five years after publication of the US guideline update. Methods We analyzed the National Inpatient Sample from 2012‐2019. ICD‐9 and ICD‐10 codes identified Ischemic stroke and mechanical thrombectomy patients. Similar to the previous study, discharge to home was the primary efficacy outcome measure in this study since it strongly correlates with mild degree of disability at discharge and 3 months post‐stroke. Safety outcomes include in‐hospital medical complications and mortality. We utilized multivariate logistic regression to assess outcomes. Results From 2012‐2019, 4,003,405 individuals with a diagnosis of ischemic stroke were recorded, 103,605 (2.6%) of which were treated with mechanical thrombectomy, proportionally increased from 4,910/452,905 (1.1%) in 2012 to 26,365/552,780 (4.8%) in 2019. The proportion of endovascular thrombectomy performing hospitals nearly doubled during the study period from 2012 (295/4,378; 6.7%) to 2019 (582/4,568; 12.7%). Odds of a mild disability outcome increased from 16% to 20%, OR 0.65 (0.57, 0.74), while mortality decreased from 15% to 12%, OR 0.69 (0.61, 0.78). Compared with 2012‐2014, the 2015‐2019 cohort showed increased odds of ICH and shock while the odds of DVT, pulmonary embolism, pneumonia, and UTI were significantly lower. The presence of septicemia, shock, and cardiac arrest were unchanged. Conclusion The number of large vessel occlusion stroke patients receiving mechanical thrombectomy treatment in the United States is increasing rapidly each year after the 2015 US guideline update. As the use of mechanical thrombectomy expands, included patients have more medical complications at baseline, but experience fewer complications, peri‐procedural mortality and overall improved outcomes.

Outbreak Investigation: First Ten COVID – 19 Infection Related Deaths in Hodeidah, Yemen

Background: Many acute respiratory syndrome coronavirus 2 (SARS-CoV-2) related deaths were reported in Yemen. The question is about what risk factors contribute to this excess death. Hodeidah governorate in the Western part of Yemen is exposed to the COVID-19 pandemic like other governorates in Yemen, adding to the current chronic problems. No study till now documented the SARS-CoV-2 pandemic process in Hodeidah, Yemen, especially deaths.&#x0D; Objective: The aim of this short report is to explore more data about the first ten SARS-CoV-2-related deaths in Hodeidah. Yemen. &#x0D; Methods: An outbreak investigation was carried out directly with patients before death and their families based on world health organization (WHO) guideline and Center for Disease Control and Prevention -US (CDC-US) guideline. On the other hand, the medical reports of patients were investigated in the triage area of the Center of Tropical Medicine and Infectious Diseases (CTMID), AL-Thawrah Public Hospital Authority, Hodeidah, Yemen from 24th to 31st May 2020.&#x0D; Results: The first ten death patients at the same time were investigated, the age ranging from 25-65 years with a median age of 57 years, seven deaths (70%) were at age over 50 years while males are more exposed to deaths (eight cases; 80%). The deaths are more in residents of urban (eight cases; 80%) than in rural areas (20%). Co-infections with other communicable diseases were reported in 3 dead patients (30%); tuberculosis, dengue, and hepatitis B (HVB). While six died patients (60%) had non-communicable diseases namely diabetes mellitus, heart disease, hypertension, chronic asthma, and chronic renal failure uncontrolled. One death (10%) of medication error in the private sector (non–isolation center facilities ; sub-standard management)&#x0D; Conclusion: Old age and co-morbidity with non-communicable diseases may be contributing factors to excess deaths among SARS-CoV-2 patients. Co-infections with other infections like dengue is of high concern in Hodeidah, Yemen. The post-epidemiological investigation, the control and prevention measures were implemented by local authorities in collaboration with the private sector and non-governmental organizations namely re-habitation of SARS-CoV-2 isolation centers to reduce the mortality rate, also different practices and knowledge to reduce the morbidity rate.

Discriminative capacity of guideline recommendations in the assessment of patients with asymptomatic microhematuria.

Asymptomatic microhematuria (aMh) remains a diagnostic challenge in urological practice: while aMh is a risk factor of urothelial carcinoma (UC), prevalence of aMh is high. Guidelines were developed to permit risk stratification and reduce diagnostic workload. This study investigates the efficacy of several recommendations. Sixty hundred eight patients with newly diagnosed aMh without previous UC from an academic referral center (A; n = 320) and a private outpatient clinic (B; n = 288) were included. All patients underwent clinical workup including medical history, urine cytology, upper tract imaging and cystoscopy. Eleven former and current guidelines were applied to each patient individually; every patient was classified as either low risk (no further workup recommended) or high risk. Furthermore, a recently developed nomogram for hematuria assessment was included. The cohort comprised 142 females and 466 males (mean age 62 [range 18-92] years). Sixty-one patients (10.0%) were diagnosed with UC. Excluding the Swedish and recent NICE guideline generally advising against urologic workup, application of 9 other recommendations would have diagnosed all UCs and saved 1.6% to 16.1% of patients from workup. For the 2020 US guideline, solely applied to cohort B, 10.6% of patients were classified as low risk. The use of the nomogram would have saved 17.1% to 25% of patients from workup. Practical relevance of current guidelines is limited as they do not sufficiently identify patients not requiring clinical work up. Thus, guideline adherence may trigger overdiagnosis and even overtreatment. New ways of risk stratification are needed to improve aMh assessment.

Liposuction for Lipedema: 2022 Update

&#x0D; A 2022 UK guideline recommends that the liposuction procedure for treatment of lipedema should only be used in the context of research because of inadequate efficacy and safety data.&#x0D; A 2021 US guideline recognizes that liposuction is currently the only available technique for removing abnormal lipedema tissue. The guideline has a series of consensus statements on patient selection, indications for liposuction, prevention of procedure-related adverse events, and pre- and post-surgical management.&#x0D; There were no recent studies on the clinical effectiveness of liposuction compared with no treatment or to alternative treatments for the treatment of lipedema.&#x0D;

Effect of anticancer therapy on mortality and COVID-19 severity in cancer patients with COVID-19.

e22510 Background: Cancer patients are more susceptible to severe complications and high mortality from Coronavirus disease 2019 (COVID-19). There is no solid evidence of whether anti-cancer therapy plays a significant role in increasing COVID-19 severity or mortality in cancer patients. Also, there is no definitive US guideline on how to justify anti-cancer treatment in cancer patients with COVID-19. Therefore, we conducted a systematic review and meta-analysis of the effect of anti-cancer therapy in cancer patients infected with COVID-19. Methods: A systematic search of Pubmed and Cochrane databases was conducted and two reviewers screened the articles independently. Previously published review articles were also evaluated to include the studies not identified in the Pubmed and Cochrane. Any clinical study of adults was included if it contains data on mortality or COVID-19 severity in cancer patients, both treated and untreated within 3 months before COVID diagnosis. Pooled odds ratio (OR) and 95% confidence intervals (CI) were calculated by employing the random-effects model, Mantel-Hazel method. Review Manager (RevMan) Version 5.4, The Cochrane Collaboration 2020 was used. Results: Out of 1690 studies identified from the databases and 8 studies from previous review articles, 22 studies (4777 patients) were included for analysis of the effect on mortality, and 12 studies (1898 patients) were included for the effect on COVID-19 severity. There were no significant differences in mortality between patients receiving anticancer treatment and those not (OR 1.17, 95% CI: [0.92-1.49], I2 = 56%, p = 0.21). There were no significant differences in mortality between patients receiving chemotherapy and those not receiving anticancer treatment but there was a trend towards higher mortality in patients receiving chemotherapy. (OR 1.43, 95% CI: [0.96-2.15], I2 = 68%, p = 0.08). There were no significant differences in COVID-19 severity between patients receiving anticancer treatment (OR 1.43, 95% CI: [0.96-2.15],, I2 = 10%, p = 0.27) and those not and between patients receiving chemotherapy and those not receiving anticancer treatment (OR 1.17, 95% CI: [0.83-1.65], I2 = 10%,p = 0.36). Conclusions: The results of our study were similar to previous meta-analyses despite more clearly defining anti-cancer treatment recency (anti-cancer treatment within 3 months before COVID diagnosis). There was low heterogeneity among studies for COVID-19 severity but high heterogeneity among studies for mortality. Most of the studies we analyzed were conducted in the 2020 and pre-vaccine era. Novel COVID-19 treatments and vaccination will likely affect outcomes in cancer patients with or without anti-cancer treatment. We need updated research and more detailed guidelines on anti-cancer therapy in COVID-19 infections.

Concentrations and Toxic Implications of Dioxin-Like Polychlorinated Biphenyls in Soil Samples from Electrical Power Stations in Lagos, Nigeria.

Dioxin-like polychlorinated biphenyls (dl-PCBs) are ubiquitous chemicals which mediate toxicity in a way similar to polychlorinated dibenzo-p-dioxins and polychlorinated dibenzofurans. In silico modeling was used to predict the absorption, distribution, metabolism, excretion, and toxicity (ADMET) properties of eight dioxin-like PCBs in soil samples of 12 power stations in Lagos, Nigeria. Concentrations of Σdl-PCB8 in soil samples ranged from 490 to 61,000 pg g-1 , with mean concentrations of 17,000 pg g-1 . The corresponding toxic equivalent (TEQ) concentrations of Ʃdl-PCB8 ranged from 0.01 to 450 pg TEQ g-1 , with a mean value of 42 pg TEQ g-1 . Mean TEQ concentrations for Ʃdl-PCB8 in soil samples from all but one of the sites exceeded the Canadian guideline value of 4 pg TEQ g-1 and the US and German guideline values of 5-10 pg TEQ g-1 . However, the TEQ concentrations obtained were all below the US action level of 1000 pg TEQ g-1 . The ADMET predictions revealed that all studied dl-PCBs are inhibitors of three major isoforms (1A2, 2C9, and 2C19) of cytochrome P450 enzyme. Acute oral toxicity (median lethal dose) predictions revealed that all target dl-PCBs were class III compounds. Hepatotoxicity and carcinogenicity were positive, signifying that the studied compounds all have a tendency to elicit these effects. Occupational daily TEQ exposure via soil ingestion was estimated for an average adult worker weighing 70 kg. The maximum exposure obtained was 0.14 pg TEQ kg-1 body weight day-1 , which is half of the European Food Safety Authority (EFSA) tolerable daily intake (TDI) for dioxin-like compounds. This raises concern over the possible exceedance of the EFSA TDI for these workers if other dietary and nondietary exposure pathways and dioxin-like compounds are considered. Environ Toxicol Chem 2022;41:800-809. © 2021 SETAC.

Significance of Category Classification of Novel Medical Products Originated from Japanese Academic Researches with Regards to Its Industrialization

This communication to chief editor discussed category classification process of medical products originated from Japanese academic researches, showing that of authors’ product for example. US guideline in 2017, “Classification of Products as Drugs and Devices & Additional Products. Classification Issues: Guidance for Industry and FDA Staff. Final Guidance”, was refereed and key provisions for device definition were introduced. In US, medical products were defined as device when primary intended purpose of the product was not achieved through chemical action. Examples of FDA’s device definition of two kinds of heat generating nanoparticles were shown as gold nanoparticles illustrated in the guideline and magnetite cationic lipid composite particles (formerly named magnetite cationic liposomes) originated from Japanese academic research. Concerning category classification process in Japan, necessity of detailed discussion between academia and administrative agency was issued in order to facilitate its technology transfer to Japanese industry.

Cardiovascular Harm From Egg Yolk and Meat: More Than Just Cholesterol and Saturated Fat.

Cardiovascular Harm From Egg Yolk and Meat: More Than Just Cholesterol and Saturated Fat.

Patterns of Mechanical Thrombectomy for Stroke Before and After the 2015 Pivotal Trials and US National Guideline Update

BackgroundPositive pivotal trials followed by guideline endorsement can be a major driver of change in US national medical practice patterns. We therefore analyzed national trends in the use and outcomes of mechanical thrombectomy for acute ischemic stroke due to large vessel occlusion before and after the 2015 publication of pivotal trials and the US guideline update. MethodsWe analyzed the National Inpatient Sample from 2012-2016. Ischemic stroke and mechanical thrombectomy patients were identified using ICD-9 and ICD-10. The primary efficacy outcome measure was discharge to home, which strongly correlates with mild degree of disability at discharge. Safety outcomes include in-hospital mortality and in-hospital medical complications. ResultsFrom 2012-2016, 2,394,550 discharges were recorded with a diagnosis of ischemic stroke, including 39,150 (1.6%) treated with mechanical thrombectomy. The number and proportion of stroke patients undergoing mechanical thrombectomy annually rose from 4,910/452,905 (1.1%) in 2012 to 11,860/509,215 (2.3%) in 2016. The largest annual increase occurred between 2014, when 6,460 stroke patients were treated with thrombectomy, and 2015, when 10,280 underwent thrombectomy. Comparing the pre (Q1 2012 - Q4 2014) and post (Q4 2015 – Q4 2016) RCT/Guideline epochs, in addition to increased thrombectomy rates, the proportion of thrombectomy patients who received IV-tPA decreased (46% to 24%, p<0.001). Rates of mild disability outcome increased from 16% to 20% (p<0.001), while mortality decreased from 15% to 13% (p=0.01). The odds of pulmonary embolism, urinary tract infection, and pneumonia decreased, while intracerebral hemorrhage, septicemia, deep venous thrombosis, shock, and cardiac arrest were unchanged. ConclusionIn the United States, thrombectomy treatment for acute ischemic stroke increased rapidly and substantially in frequency following publication of positive clinical trials and US guideline update in 2015, accompanied by improved functional outcomes and reduced peri-procedural mortality.

Abstract WP29: National Patterns of Stroke Mechanical Thrombectomy Before and After the 2015 American Stroke Association Focused Update Endovascular Treatment Guidelines

Introduction: Positive pivotal trials followed by guideline endorsement can be a major driver of change in US national medical practice patterns. We therefore analyzed national trends in the use and outcomes of mechanical thrombectomy (MT) for acute ischemic stroke (IS) due to large vessel occlusion before and after the 2015 publication of pivotal trials and the US guideline update. Methods: We analyzed the National Inpatient Sample from 2012-2016. IS and MT patients were identified using ICD-9 and ICD-10. The primary efficacy outcome measure was discharge to home, which strongly correlates with mild disability at discharge. Safety outcomes include in-hospital mortality and in-hospital medical complications. Results: Between 2012-2016, 2,394,550 discharges had diagnosis of IS, 39,150 (1.6%) underwent MT. The number and proportion of IS patients undergoing MT rose from 4,910/452,905 (1.1%) in 2012 to 11,860/509,215 (2.3%) in 2016. The largest increase occurred between 2014, when 6,460 stroke patients were treated with MT, and 10,280 in 2015. Comparing the pre (Q1 2012-Q4 2014) and post (Q4 2015 - Q4 2016) RCT/Guideline epochs, in addition to increased MT rates, the proportion of MT patients who received IV-tPA decreased (46% to 24%, p&lt;0.001). Rates of mild disability outcome increased from 17% to 20% (p=0.04), while mortality decreased from 17.7% to 15% (p=0.03). The odds of pulmonary embolism, urinary tract infection, and pneumonia reduced, while intracranial hemorrhage, sepsis, deep venous thrombosis, shock, and cardiac arrest were unchanged. Conclusion: In US, thrombectomy treatment for acute ischemic stroke increased rapidly and substantially in frequency following publication of positive clinical trials and a US guideline update in 2015, accompanied by improved functional outcomes and reduced peri-procedural mortality.

How to Manage a Patient With Gastric Intestinal Metaplasia: An International Perspective

How to Manage a Patient With Gastric Intestinal Metaplasia: An International Perspective

Prevalence and Prediction of Aneurysmal Dilatation of the Abdominal Aorta in Koreans: Results of Screening During Transthoracic Echocardiographic Examination.

BACKGROUNDAortic aneurysm (AA) is an enlargement of the aorta to greater than 1.5 times normal size. Although the US guideline recommends ultrasound screening for abdominal AA (AAA) in men older than 65 years regardless of symptoms, limited data describe the prevalence of AAA in Korea. In this study, we screened patients for AAA during transthoracic echocardiographic examination (TTE).METHODSWe screened for AAA in all consecutive subjects older than 60 years who underwent TTE. We defined AAA as an abdominal aorta with the diameter greater than 30 mm.RESULTSWe analyzed 5,679 persons (2,272 females, 74 ± 8 years old). The mean size of the abdominal aorta was 19.0 ± 6.1 mm. The prevalence of AAA was 2.9% (165/5,679) and was significantly higher in males (4.7% vs. 1.1%, p < 0.001). AAA was significantly associated with male sex (odds ratio [OR] = 3.098, 95% confidence interval [CI] = 1.971-4.870, p < 0.001), older age (OR = 1.074, 95% CI = 1.050-1.097, p < 0.001), non-diabetes (OR = 1.886, 95% CI = 1.264-2.813, p < 0.001), dyslipidemia (OR = 1.475, 95% CI = 1.019-2.135, p = 0.040), ever-smoker (OR = 2.090, 95% CI = 1.448-3.015, p < 0.001), chronic kidney disease (CKD, OR = 1.757, 95% CI = 1.182-2.612, p = 0.005), and coronary artery disease (CAD, OR = 2.452, 95% CI = 1.742-3.451, p < 0.001). A prediction score with a multivariate model (range: 3.34-10.51) detected AAA with a sensitivity of 79.4% and a specificity of 66.8% with a reference value > 6.8 (area under the curve = 0.799).CONCLUSIONSIn Korea, the prevalence of AAA was 2.9% in subjects older than 60 years during TTE, and AAA was significantly associated with older age, male sex, non-diabetes, dyslipidemia, ever-smoker, CKD, and CAD. Prediction score (> 6.8%) detected AAA with a sensitivity of 79.4% and a specificity of 66.8%.

Determining Levers of Cost-effectiveness for Screening Infants at High Risk for Peanut Sensitization Before Early Peanut Introduction

Early peanut introduction reduces the risk of developing peanut allergy, especially in high-risk infants. Current US recommendations endorse screening but are not cost-effective relative to other international strategies. To identify scenarios in which current early peanut introduction guidelines would be cost-effective. This simulation/cohort economic evaluation used microsimulations and cohort analyses in a Markov model to evaluate the cost-effectiveness of early peanut introduction with and without peanut skin prick test (SPT) screening in high-risk infants during an 80-year horizon from a societal perspective. Data were analyzed from April to May 2019. High-risk infants with early-onset eczema and/or egg allergy underwent early peanut introduction with and without peanut SPT screening (100 000 infants per treatment strategy) using a dichotomous 8-mm SPT cutoff value (stipulated in the current US guideline). Cost, quality-adjusted life-years (QALYs), net monetary benefit, peanut allergic reactions, severe allergic reactions, and deaths due to peanut allergy. In the simulated cohort of 200 000 infants and using the base case during the model horizon, a no-screening approach had lower mean (SD) costs ($13 449 [$38 163] vs $15 279 [$38 995]) and higher mean (SD) gain in QALYs (29.25 [3.28] vs 29.23 [3.30]) vs screening but resulted in more allergic reactions (mean [SD], 1.07 [3.15] vs 1.01 [3.02]), severe allergic reactions (mean [SD], 0.53 [1.66] vs 0.52 [1.62]), and anaphylaxis involving cardiorespiratory compromise (mean [SD], 0.50 [1.59] vs 0.49 [1.47]) per individual. In deterministic SPT sensitivity analyses at base-case sensitivity and specificity rates, screening could be cost-effective at a high disutility rate (the negative effect of a food allergic reaction) (76-148 days of life traded) for an at-home vs in-clinic reaction in combination with high baseline peanut allergy prevalence among infants at high risk for peanut allergy and not yet exposed to peanuts. If an equivalent rate and disutility of accidental and index anaphylaxis was assumed and the 8-mm SPT cutoff had 0.85 sensitivity and 0.98 specificity, screening was cost-effective at a peanut allergy prevalence of 36%. The results of this study suggest that the current screening approach to early peanut introduction could be cost-effective at a particular health utility for an in-clinic reaction, SPT sensitivity and specificity, and high baseline peanut allergy prevalence among high-risk infants. However, such conditions are unlikely to be plausible to realistically achieve. Further research is needed to define the health state utility associated with reaction location.

Risk Categorization Using New American College of Cardiology/American Heart Association Guidelines for Cholesterol Management and Its Relation to Alirocumab Treatment Following Acute Coronary Syndromes.

The 2018 US cholesterol management guidelines recommend additional lipid-lowering therapies for secondary prevention in patients with low-density lipoprotein cholesterol ≥70 mg/dL or non-high-density lipoprotein cholesterol ≥100 mg/dL despite maximum tolerated statin therapy. Such patients are considered at very high risk (VHR) based on a history of >1 major atherosclerotic cardiovascular disease (ASCVD) event or a single ASCVD event and multiple high-risk conditions. We investigated the association of US guideline-defined risk categories with the occurrence of ischemic events after acute coronary syndrome and reduction of those events by alirocumab, a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor. In the ODYSSEY OUTCOMES trial (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab), patients with recent acute coronary syndrome and residual dyslipidemia despite optimal statin therapy were randomly assigned to alirocumab or placebo. The primary trial outcome (major adverse cardiovascular events, ie, coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, or hospitalization for unstable angina) was examined according to American College of Cardiology/American Heart Association risk category. Of 18 924 participants followed for a median of 2.8 years, 11 935 (63.1%) were classified as VHR: 4450 (37.3%) had multiple prior ASCVD events and 7485 (62.7%) had 1 major ASCVD event and multiple high-risk conditions. Major adverse cardiovascular events occurred in 14.4% of placebo-treated patients at VHR versus 5.6% of those not at VHR. In the VHR category, major adverse cardiovascular events occurred in 20.4% with multiple prior ASCVD events versus 10.7% with 1 ASCVD event and multiple high-risk conditions. Alirocumab was associated with consistent relative risk reductions in both risk categories (hazard ratio=0.84 for VHR; hazard ratio=0.86 for not VHR; Pinteraction=0.820) and by stratification within the VHR group (hazard ratio=0.86 for multiple prior ASCVD events; hazard ratio=0.82 for 1 major ASCVD event and multiple high-risk conditions; Pinteraction=0.672). The absolute risk reduction for major adverse cardiovascular events with alirocumab was numerically greater (but not statistically different) in the VHR group versus those not at VHR (2.1% versus 0.8%; Pinteraction=0.095) and among patients at VHR with multiple prior ASCVD events versus a single prior ASCVD event (2.4% versus 1.8%; Pinteraction=0.661). The US guideline criteria identify patients with recent acute coronary syndrome and dyslipidemia who are at VHR for recurrent ischemic events and who may derive a larger absolute benefit from treatment with alirocumab. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01663402.

Consensus on the diagnostic and therapeutic management of chronic spontaneous urticaria in adults - Brazilian Society of Dermatology.

BackgroundUrticarias are frequent diseases, with 15% to 20% of the population presenting at least one acute episode in their lifetime. Urticaria are classified in acute ( ≤ 6 weeks) or chronic (> 6 weeks). They may be induced or spontaneous.Objectives To verify the diagnostic and therapeutic recommendations in chronic spontaneous urticaria (CSU), according to the experience of Brazilian experts, regarding the available guidelines (international and US).MethodsA questionnaire was sent to Brazilian experts, with questions concerning diagnostic and therapeutic recommendations for CSU in adults.ResultsSixteen Brazilian experts answered the questionnaire related to diagnosis and therapy of CSU in adults and data were analyzed. Final text was written, considering the available guidelines (International and US), adapted to the medical practices in Brazil. Diagnostic work up in CSU is rarely necessary. Biopsy of skin lesion and histopathology may be indicated to rule out other diseases, such as, urticarial vasculitis. Other laboratory tests, such as complete blood count, CRP, ESR and thyroid screening. Treatment of CSU includes second-generation anti-histamines (sgAH) at licensed doses, sgAH two, three to fourfold doses (non-licensed) and omalizumab. Other drugs, such as, cyclosporine, immunomodulatory drugs and immunosuppressants may be indicated (non-licensed and with limited scientific evidence).ConclusionsMost of the Brazilian experts in this study partially agreed with the diagnostic and therapeutic recommendations of the International and US guidelines. They agreed with the use of sgAH at licensed doses. Increase in the dose to fourfold of sgAH may be suggested with restrictions, due to its non-licensed dose. Sedating anti-histamines, as suggested by the US guideline, are indicated by some of the Brazilian experts, due to its availability. Adaptations are mandatory in the treatment of CSU, due to scarce or lack of other therapeutic resources in the public health system in Brazil, such as omalizumab or cyclosporine.

Blood Pressure Down Under, but Down Under What? US and Australian Hypertension Guideline Conversation.

See related article, pp e13–e115 Australia shares similar blood pressure (BP) profiles within the community as the United States, Europe, and many other countries.1 Hypertension is common, many people are not aware they have it and treatment often falls short of targets. Improvement in smoking rates and other cardiovascular risk factors is being countered by increased obesity and diabetes mellitus. Hypertension is seen more often in disadvantaged people, in rural communities, and particularly indigenous Australians.2 This is a familiar story around the world and it will not surprise that Australian hypertension guidelines have generally been fairly similar to recommendations in the major European and US guidelines. The American College of Cardiology/American Heart Association (ACC/AHA) recently revised guidelines for the diagnosis, treatment, and management of hypertension.3 Among a host revisions, which have been referred to as radical,4 there are; lower cut offs for the diagnosis of hypertension (BP ≥130/80 mm Hg, previously set at ≥140/90 mm Hg), similarly lower BP criteria for initiating antihypertensive medications, and revised BP targets for individuals already undergoing treatment. US population implications of these changes include an additional 31 million US individuals considered hypertensive just because of the change in threshold, 4.2 million of these newly diagnosed are now eligible for antihypertensive medication.5 Additionally, over half (53%) of those currently medicated (55 million individuals) are in need of improved antihypertensive control to meet newly defined targets. The process for developing these ACC/AHA guidelines was gold standard with extensive review of the evidence, broad consultation, and rigorous attention to conflict of interest. In this context, it will not surprise if other countries follow the same line and draw similar conclusions. After all the evidence is the evidence! There will always be some divergence as local factors and local evidence comes into play …

Correlation Between Cytologic Results and Thyroid Autoantibodies, Calcitonin, and Thyroid Function Tests in Patients with Thyroid Nodules

Abstract&#x0D; Background: Fine needle aspiration biopsy (FNAB) is currently a widely accepted screening procedure in diagnosis of thyroid nodules, there has been confusion related to diagnostic terminology in the assessment of samples. This confusion has been caused by multiple category names, descriptive reports without assigning to a category, and different terminologies used for surgical pathology. We aimed to evaluate correlations between US characteristics, cytologic results of FNAB, and thyroid antibodies, calcitonin, and thyroid function tests in patients presented with thyroid nodules, and to contribute in diagnosis, treatment, and patient follow-up.&#x0D; Methods: A total of 1639 patients with thyroid nodules who applied to outpatient clinic of endocrinology between dates April and May 2017, had FNAB under US guideline, and their pathologic evaluation was performed according to Bethesda classification. Serological and hormonal tests were also performed for each patient.&#x0D; Results: The mean age of study group was 50 (range interval= 14-90) years. The median of node-diameter1 was 17.5 (range=1-51) mm, and median of node-diameter2 was 12 (range=8-33) mm. Of US characteristics, echogenicity, microcalcification, irregular borders, and solitary nodules were determined in 4.4%, 54%, 71.2%, and 86.6% of cohort respectively. Elevated anti-TPO was determined in 64.6%. Cytologic readings were reported as 15.8% nondiagnostic, 53.8% atypia of undetermined significance/follicular lesion of undetermined significance, 28.8% benign, 0.4% suspicious for follicular nodule, and 1.2% malign. &#x0D; Conclusion: Measurement of thyroid autoantiboides, calcitonin, and thyroid function tests have good correlations with Bethesda classification in patients with thyroid nodules.