Review Of Clinical Guidelines Research Articles

Abstract 4628: Validation of an automated, scalable comprehensive genomic profiling assay for hematologic malignancies

Abstract Optimal diagnosis, prognosis, and treatment selection for hematologic malignancies requires assessment of somatic mutations across a subset of clinically relevant genes. Here we present the analytical validation results of an expanded targeted next generation sequencing (NGS) panel of 141 clinically relevant genes for myeloid and lymphoid malignancies. Based on review of clinical guidelines, 141 genes including 79 myeloid and 84 lymphoid associated genes were selected. The expanded hematological panel interrogates all coding exons of the 141 genes to detect single nucleotide variants (SNVs) and insertions/deletions (indels). The panel also identifies copy number aberrations (CNAs) in 16 genes, FLT3 internal tandem duplicates (ITDs), select non-coding pathogenic variants, and patient sex. The custom hybrid capture-based assay utilizes genomic libraries created from 250 ng gDNA extracted from peripheral blood, bone marrow, or cell suspensions, followed by sequencing on Illumina® instruments. Concordance studies were performed on clinical samples previously assessed using an orthogonal NGS-based laboratory developed test for SNVs/indels/FLT3-ITDs or digital multiplexed ligation-dependent probe amplification for CNAs. In total, 308 patient samples were evaluated and included 72 (23.4%) acute myeloid leukemia and 58 (18.8%) myelodysplastic syndromes samples among other indications, of which 240 (77.9%) were bone marrow specimens. Analysis of concordance demonstrated a positive percent agreement (PPA) of 99.7% for SNVs (750/752), 99.5% for indels <25bp (206/207), and 95.7% for indels ≥ 25bp (22/23). Variants were from 45 genes including TP53, NPM1, and IDH1/2. PPA was 100% for FLT3-ITDs (38/38; size range 18-300 bp) and sex (294/294). For CNAs, PPA was 96.4% (132/137) and negative percent agreement (NPA) was 98.3% (931/947). Assay precision was determined using three replicates of 15 clinical samples for both intra and inter-assay precision using multiple operators, instruments, and reagent lots. 100% concordance was observed for SNVs (36/36), indels (11/11), a 24 bp FLT3-ITD (1/1), CNAs (24/24), and sex (15/15). Analytical specificity was assessed using 5 replicates of NA12878 showing specificity >99.99% for SNVs/indels with variant allele frequency ≥ 3%, and >99.99% for CNAs with copy number ≤0.85 or ≥1.15. Dilution series to determine analytical sensitivity are in progress. This study highlights the analytical validation of the expanded NGS panel for the detection of clinically informative genomic alterations in hematologic malignancies. Results from this validation study, when complete, will include at least 576 samples plus orthogonal testing. These data describe the performance of the assay to enable a comprehensive evaluation of genomic alterations using a single sample, further facilitating the use of broad NGS assays in patients with hematologic malignancies. Citation Format: Grant Hogg, Tong Liu, Helen Cao, Adib Shafi, Ashraf Shabaneh, Jon Williams, John Howitt, Amanda Williamson, Rachel Dango, Xiaojun Guan, Heidi Hoffmann, Michael Mooney, John Pruitt, Scott Parker, Henry Dong, Stan Letovsky, Li Cai, Eric A. Severson, Shakti H. Ramkissoon, Anjen Chenn, Marcia Eisenberg, Brian Caveney, Eyad Almasri, Taylor J. Jensen. Validation of an automated, scalable comprehensive genomic profiling assay for hematologic malignancies [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 4628.

The role of direct oral anticoagulants in cancer-associated thrombosis. Review of clinical guidelines and real practice

The role of direct oral anticoagulants in cancer-associated thrombosis. Review of clinical guidelines and real practice

Efficacy and safety of pharmacotherapy in chronic insomnia: A review of clinical guidelines and case reports.

Chronic insomnia affects 5% to 10% of the US population, increasing the demand for treatment options and the corresponding research to prove their validity.1 This review compares recommendations from 3 clinical guidelines and summarizes hypnotic medications, including their newly reported side effects not mentioned in the guidelines. In addition, we aim to provide an overview of what pharmacotherapies are available for prescribers and patients. A literature search was conducted for articles published prior to January 10, 2022, and case reports and clinical studies were retrieved from PubMed and Google Scholar. Definitive conclusions cannot be drawn regarding the safety and efficacy of medications reviewed; however, trends are apparent. All 3 guidelines included in this review remarked most treatment recommendations as weak except for cognitive behavioral therapy for insomnia, which is effective but not readily available. Furthermore, based on the 15 case reports and 13 clinical studies presented in this review, many of the medications used for treatment of insomnia present safety concerns. Benzodiazepines and benzodiazepine receptor agonists are commonly used hypnotic agents with the "Z-drugs" having robust data establishing their efficacy for the short-term treatment of chronic insomnia. However, significant adverse effects related to the central nervous system (CNS), including developing tolerance, addiction, CNS depression, and amnesia, remain barriers to their long-term use. In comparison, newer agents present more favorable side-effect profiles although with less established efficacy. Additionally, off-label agents, including antidepressants, antihistamines, and natural supplements, are discussed due to their prominent use.

Abstract 6220: Development of a mutation profiling NGS assay to facilitate clinical decisions in hematologic malignancies

Abstract Introduction: Accurate diagnosis, prognosis and treatment of hematologic disorders from both myeloid and lymphoid origin requires assessing somatic mutation status in an increasingly large number of genes. Here we present the results of the assay development and validation of a targeted next generation sequencing panel which provides full exon sequencing of 141 genes associated with myeloid and lymphoid malignancies, as well as the ability to detect clinically relevant copy number alterations (CNAs) and certain sub-gene level CNAs. Methods: Based on review of clinical guidelines, 141 genes including 72 myeloid and 84 lymphoid associated genes were selected. The assay interrogates all coding exons of the 141 genes to detect single nucleotide variants (SNVs) and insertions/deletions (indels). The assay also identifies CNAs in 16 genes, FLT3 internal tandem duplicates (ITDs), and select non-coding pathogenic variants. The custom hybrid capture-based assay utilizes genomic libraries created from 250 ng gDNA extracted from peripheral blood or bone marrow followed by sequencing on Illumina sequencers. Concordance studies were performed on clinical samples previously assessed using an orthogonal NGS-based laboratory developed test for SNVs/Indels or digital multiplexed ligation-dependent probe amplification for CNAs. In addition, analytical sensitivity was assessed using cell line dilution series and specificity by reference samples from Genome in a Bottle (GIAB). Small indels were defined as <25bp while long indels are ≥ 25bp. Results: Interim estimates of positive percentage agreement (PPA) and specificity have been determined for SNV/Indels, FLT3-ITDs, and CNVs, with further testing ongoing. PPA of SNVs was 100% (218/218 SNVs; n = 134 samples). PPA was also 100% for both small indels (21/21; n = 14 samples) and long indels (6/6; n = 6 samples). A dilution series of 8 positive clinical samples at 4 different dilutions showed SNV and small indel detection of 100% at allele frequency (AF) ≥ 3%. Long indel detection was 87.5% at AF ≥ 5%. FLT3-ITD was evaluated with 2 cell line samples at 5 different dilutions with 100% detection at AF ≥ 5%. PPA of CNAs were 95.7% (157/164) in 46 clinical samples. CNA detection was also evaluated with 8 cell line samples at 4 different dilutions showing 92.3% detection at a copy number ratio threshold ± 0.15. A preliminary estimate of specificity was determined using 4 replicates of the GIAB sample, NA12878, and was >99.99% for SNVs and small indels (n=6.9 × 105). Finally, a model for gender classification was created using a training cohort of 70 clinical samples. The performance was evaluated on a test set of 144 clinical samples with 100% PPA (144/144). Conclusions: Taken together, these data demonstrate that the developed NGS assay is a sensitive, specific, and accurate assay with high clinical utility to inform treatment decision making in hematologic malignancies. Citation Format: Grant Hogg, Tong Liu, Helen Cao, Adib Shafi, Ashraf Shabaneh, John Howitt, Amanda Williamson, Rachel Dango, Xiaojun Guan, Heidi Hoffmann, Michael Mooney, John Pruitt, Scott Parker, Stan Letovsky, Li Cai, Eric A. Severson, Shakti Ramkissoon, Anjen Chenn, Marcia Eisenberg, Eyad Almasri, Taylor Jensen. Development of a mutation profiling NGS assay to facilitate clinical decisions in hematologic malignancies [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 6220.

Wilson’s disease: a review of clinical guidelines, literature and a case report

Wilson’s disease (hepatocerebral dystrophy) is a rare hereditary disease that is caused by impaired copper metabolism affecting many organs, but mainly the liver and nervous system. Interest in the problem does not subside, because diagnosis and management of patients presents certain difficulties. The article highlights the literature data, clinical recommendations when discussing their own clinical observation of two patients (brother and sister) in whom the disease was diagnosed in childhood. Presented are clinical data, dynamics of laboratory parameters during 15 years of follow-up against the background of adequate chelation therapy with D-penicylamine and zinc sulfate, as well as during interruption of treatment. The necessity of adherence to a lifelong regimen of therapy is emphasized, since it is this tactic that demonstrates effectiveness in improving the prognosis of the disease.

A Scoping Review of Global Guidelines for the Disclosure of Secondary Genomic Findings to Inform the Establishment of Guidelines in China.

The detection and disclosure of secondary findings (SFs) is a preventive strategy for medically-actionable hereditary health conditions. Some countries have guidelines on management and disclosure of SFs, while others avoid detection and disclosure of SFs. This study is a review of clinical guidelines from six countries and the European Union to identify similarities and differences among SF guidelines. Evidence from this review supports harmonization of guidelines across countries to promote broad international collaborations on genomics and to benefit precision medicine. This study can serve as a reference for development of SF management guidelines in China by contributing evidence from other countries to the ethical and methodological challenges under debate.

A brief review of clinical guidelines for the diagnosis and treatment of exocrine pancreatic insufficiency

In recent years, several consensus and guidelines for the diagnosis and treatment of chronic pancreatitis have been published. In 2017, the Russian and Pan-European (HaPanEU) consensus was published, in 2018 — the international consensus on minimal change pancreatitis, in 2020 — the clinical guidelines of the American College of Gastroenterology, in 2021 — the British clinical guidelines. Many of their provisions overlap. This review article analyzed the main provisions of the latest recommendations, taking into account the possibility of their adaptation to Russian clinical practice.

Vaccination against COVID-19 for hematologic patients: A review of clinical guidelines

Introduction. The COVID-19 pandemic has led to the need to accelerate the development of vaccines targeting SARSCoV-2. A large number of researchers have already confi rmed that patients with cancer have a high risk of mortality from COVID-19. Hematologic diseases and the therapy of these diseases are very heterogeneous, therefore it is expected that the immune response to infection or vaccination will be more variable in this cohort of patients. Accordingly, questions arise regarding the safety and effi cacy of vaccines in the context of immune changes caused either by the hematological disease itself or by the therapy that is administered to the patient.Aim — to summarize the current understanding of the effi cacy and safety of vaccination against the SARS-CoV-2 in patients with hemoblastosis and other hematological diseases.Basic information. Legalized COVID-19 vaccines are safe and effective for the general population. Given the high mortality rate among patients with hematological diseases, which is ten times higher than the mortality rate in the general population, vaccination is a priority for this group of patients. The current lack of clinical trial data on the effectiveness and safety of vaccines against COVID-19 in hematological patients raises a large number of questions among specialists and patients. This is also due to the fact that for most of the approved vaccines immunocompromised patients were not included in the phase III clinical trials. Thus, most patients with hematological diseases could not participate in these studies, and therefore the effectiveness and safety of vaccines against the causative agent of COVID-19 have not been thoroughly studied in this group.Current recommendations for vaccination against COVID-19 in hematological patients are based on expert opinion, including past experience of immunizing these patients against other viral infections.Conclusions. Vaccination of patients with hematological diseases and their environment (medical staff, relatives, caregivers) is one of the necessary methods to prevent high mortality from a new coronavirus infection during the COVID-19 pandemic.

Cardiometabolic Risk Reduction: A Review of Clinical Guidelines and the Role of SGLT-2 Inhibitors

At the end of the activity, participants will be able to: • Identify how heart failure (HF), chronic kidney disease (CKD), and type 2 diabetes mellitus (T2DM) and associated cardiovascular (CV) risks are interconnected. • Initiate guideline-recommended therapy to reduce CV risk in patients with HF, CKD, and/or T2DM. • Apply evidence for sodium-glucose cotransporter-2 inhibitors (SGLT-2 inhibitors) to clinical practice, based on recent and emerging trials. • Review evidence suggesting increased incidence and severity of COVID-19 infection in patients with diabetes.

Review of Clinical Guidelines in the Diagnosis of Pediatric Nonalcoholic Fatty Liver Disease.

Review of Clinical Guidelines in the Diagnosis of Pediatric Nonalcoholic Fatty Liver Disease.

Review of clinical guidelines “Cystic fibrosis”, 2020

The aim of the experts who provide health care for patients with cystic fibrosis (CF) has been to develop clinical guidelines on cystic fibrosis for children and adults.Methods. The 2020 Clinical Guidelines were based on the European consensus documents on cystic fibrosis and the national consensus “Cystic fibrosis: definition, diagnostic criteria, therapy” (2016, 2019). When creating clinical guidelines, the experts were guided by Article 2 of the Federal Law No.323-FL “On the basics of health care in the Russian Federation” as of November 21st, 2011, and the regulatory legal documents governing the development and approval of clinical guidelines (https://rosmedex.ru/kr/).Results. The clinical guidelines were approved by the Federal State Budgetary Institution “Centre for Expertise and Quality Control of Medical Care” of the Russian Ministry of Health in August 2020. Standards of medical care for children and adults with cystic fibrosis were prepared based on these guidelines. The diagnostic algorithms have been expanded with a three-stage DNA diagnostic strategy, functional assays of CFTR channel, laboratory and instrumental diagnostic tools for assessing disorders of respiratory and other systems, diagnosis of the microbial inflammatory process, microbiological monitoring, and therapeutic approaches. The antibiotic therapy with dosages and courses is described in detail. The updated document should describe a unified tactic for the management of Russian CF patients.Conclusion. Unified clinical guidelines for children and adults should develop unified tactics for the diagnosis, therapy, and follow-up of CF patients in the Russian Federation and ensure continuity between health care services for children and adults.

A Review of Clinical Guidelines on the Management of Iron Deficiency and Iron-Deficiency Anemia in Women with Heavy Menstrual Bleeding.

IntroductionUp to one-third of women of reproductive age experience heavy menstrual bleeding (HMB). HMB can give rise to iron deficiency (ID) and, in severe cases, iron-deficiency anemia (IDA).AimTo review current guidelines for the management of HMB, with regards to screening for anemia, measuring iron levels, and treating ID/IDA with iron replacement therapy and non-iron-based treatments.MethodsThe literature was searched for English-language guidelines relating to HMB published between 2010 and 2020, using the PubMed database, web searching, and retrieval of clinical guidelines from professional societies.ResultsOverall, 55 guidelines mostly originating from North America and Europe were identified and screened. Twenty-two were included in this review, with the majority (16/22) focusing on guidance to screen women with HMB for anemia. The guidance varied with respect to identifying symptoms, the criteria for testing, and diagnostic hemoglobin levels for ID/IDA. There was inconsistency concerning screening for ID, with 11/22 guidelines providing no recommendations for measurement of iron levels and four contrasting guidelines explicitly advising against initial assessment of iron levels. In terms of treatment, 8/22 guidelines provided guidance on iron therapy, with oral iron administration generally recommended as first-line treatment for ID and/or IDA. Four guidelines recommended intravenous iron administration for severe anemia, in non-responders, or before surgery. Three guidelines provided hemoglobin thresholds for choosing between oral or intravenous iron treatment. Four guidelines discussed the use of transfusion for severe IDA.ConclusionMany of the guidelines for managing HMB recognize the importance of treating anemia, but there is a lack of consensus in relation to screening for ID and use of iron therapy. Consequently, ID/IDA associated with HMB is likely to be underdiagnosed and undertreated. A consensus guidance, covering all aspects of screening and management of ID/IDA in women with HMB, is needed to optimize health outcomes in these patients.

Novel Methodology to Measure Preprocedure Antimicrobial Prophylaxis: Integrating Text Mining With Structured Data

Background: Antimicrobial prophylaxis is an evidence-proven strategy for reducing procedure-related infections; however, measuring this key quality metric typically requires manual review, due to the way antimicrobial prophylaxis is documented in the electronic medical record (EMR). Our objective was to combine structured and unstructured data from the Veterans’ Health Administration (VA) EMR to create an electronic tool for measuring preincisional antimicrobial prophylaxis. We assessed this methodology in cardiac device implantation procedures. Methods: With clinician input and review of clinical guidelines, we developed a list of antimicrobial names recommended for the prevention of cardiac device infection. Next, we iteratively combined positive flags for an antimicrobial order or drug fill from structured data fields in the EMR and hits on text string searches of antimicrobial names documented in electronic clinical notes to optimize an algorithm to flag preincisional antimicrobial use with high sensitivity and specificity. We trained the algorithm using existing fiscal year (FY) 2008-15 data from the VA Clinical Assessment Reporting and Tracking-Electrophysiology (CART-EP), which contains manually determined information about antimicrobial prophylaxis. We then validated the performance of the final version of the algorithm using a national cohort of VA patients who underwent cardiac device procedures in FY 2016 or 2017. Discordant cases underwent expert manual review to identify reasons for algorithm misclassification and to identify potential future implementation barriers. Results: The CART-EP dataset included 2,102 procedures at 38 VA facilities with manually identified antimicrobial prophylaxis in 2,056 cases (97.8%). The final algorithm combining structured EMR fields and text-note search results flagged 2,048 of the CART-EP cases (97.4%). Algorithm validation identified antimicrobial prophylaxis in 16,334 of 19,212 cardiac device procedures (87.9%). Misclassifications occurred due to EMR documentation issues. Conclusions: We developed a methodology with high accuracy to measure guideline-concordant use of antimicrobial prophylaxis before cardiac device procedures using data fields present in modern EMRs that does not rely on manual review. In addition to broad applicability in the VA and other healthcare systems with EMRs, this method could be adapted for other procedural areas in which antimicrobial prophylaxis is recommended but comprehensive measurement has been limited to resource-intense manual review.Funding: NoneDisclosures: None

Обзор клинических рекомендаций по лечению детей с подтвержденной коронавирусной инфекцией COVID-19: взгляд клинического фармаколога

Обзор клинических рекомендаций по лечению детей с подтвержденной коронавирусной инфекцией COVID-19: взгляд клинического фармаколога

Is the Newborn Microbiome Disrupted by Routine Newborn Suctioning? An Exploratory Approach for Policy Development.

An invasive procedure commonly used in the perinatal setting is newborn suctioning at birth. Routine newborn suctioning, without indication, is not recommended by the American Academy of Pediatrics, the American Heart Association, and the European Resuscitation Council for the newborn with spontaneous respirations, adequate crying, and good muscle tone. Whether to suction a newborn is a difficult practice decision made daily by the perinatal nurse. A primary element of this practice decision is the consideration that newborn suctioning has the potential to affect health outcomes. Furthermore, routine newborn suctioning may be disrupting the newborn microbiome by removing commensal bacteria and potentially, negatively affecting newborn health. This article will explore the connection between the practice of routine newborn suctioning in the perinatal setting and the potential to disrupt the newborn microbiome. The methods employed and reported in this article consisted of review of literature and review of clinical guidelines and a descriptive study to determine the scope of practice of newborn suctioning. The premise of whether the practice of routine newborn suctioning at birth may be disrupting the newborn microbiome will also be considered. Finally, developing a microbiome-centric perspective will be explored.

Adverse effects information in clinical guidelines on pharmacological treatment of depression in children and adolescents: a systematic review

ObjectivesTo analyse to what extent clinical practice guidelines on drug treatment of depression in children and adolescents mention the risk of adverse effects, to characterise the citations in the guidelines...

Novel methodology to measure pre-procedure antimicrobial prophylaxis: integrating text searches with structured data from the Veterans Health Administration\u2019s electronic medical record

BackgroundAntimicrobial prophylaxis is an evidence-proven strategy for reducing procedure-related infections; however, measuring this key quality metric typically requires manual review, due to the way antimicrobial prophylaxis is documented in the electronic medical record (EMR). Our objective was to electronically measure compliance with antimicrobial prophylaxis using both structured and unstructured data from the Veterans Health Administration (VA) EMR. We developed this methodology for cardiac device implantation procedures.MethodsWith clinician input and review of clinical guidelines, we developed a list of antimicrobial names recommended for the prevention of cardiac device infection. We trained the algorithm using existing fiscal year (FY) 2008–15 data from the VA Clinical Assessment Reporting and Tracking-Electrophysiology (CART-EP), which contains manually determined information about antimicrobial prophylaxis. We merged CART-EP data with EMR data and programmed statistical software to flag an antimicrobial orders or drug fills from structured data fields in the EMR and hits on text string searches of antimicrobial names documented in clinician’s notes. We iteratively tested combinations of these data elements to optimize an algorithm to accurately classify antimicrobial use. The final algorithm was validated in a national cohort of VA cardiac device procedures from FY2016–2017. Discordant cases underwent expert manual review to identify reasons for algorithm misclassification.ResultsThe CART-EP dataset included 2102 procedures at 38 VA facilities with manually identified antimicrobial prophylaxis in 2056 cases (97.8%). The final algorithm combining structured EMR fields and text note search results correctly classified 2048 of the CART-EP cases (97.4%). In the validation sample, the algorithm measured compliance with antimicrobial prophylaxis in 16,606 of 18,903 cardiac device procedures (87.8%). Misclassification was due to EMR documentation issues, such as antimicrobial prophylaxis documented only in hand-written clinician notes in a format that cannot be electronically searched.ConclusionsWe developed a methodology with high accuracy to measure guideline concordant use of antimicrobial prophylaxis before cardiac device procedures using data fields present in modern EMRs. This method can replace manual review in quality measurement in the VA and other healthcare systems with EMRs; further, this method could be adapted to measure compliance in other procedural areas where antimicrobial prophylaxis is recommended.

Aspirin Use for Primary Prevention of Cardiovascular Disease in Older Patients: A Review of Clinical Guidelines and Updated Evidence.

OBJECTIVE: To provide an up-to-date review of current guidelines, previous trials, and new trials regarding aspirin use in primary prevention of cardiovascular (CV) disease in the elderly population. DATA SOURCES: A PubMed search of articles published through April 2019 was performed using a combination of the following words: aspirin, bleeding, cardiovascular, elderly, hemorrhage, myocardial infarction, primary prevention, stroke. STUDY SELECTION/DATA EXTRACTION: Relevant randomized controlled trials, meta-analyses, and guidelines were assessed for the use of aspirin in primary prevention of CV disease in older patients. References from the above literature were also evaluated. Articles were selected for inclusion based on relevance to the topic, detailed methods, and complete results. DATA SYNTHESIS: The role of aspirin for primary prevention of CV disease in older adults is not well defined. As a result, the guideline recommendations for the use of aspirin in this setting are inconsistent. In 2018, the ARRIVE, ASCEND, and ASPREE studies were published. These studies tried to address some of the inconsistencies regarding the use of aspirin in primary prevention of CV disease. This article reviews the current recommendations along with previous and recent studies for aspirin use for primary prevention in older adults. CONCLUSION: The role of aspirin for primary prevention of CV disease in older adults should be individualized based on patient's risk factors, including risk of CV disease and likelihood of bleeding. Updated evidence provides more guidance regarding which patient populations will benefit from therapy.

Aspirin Use for Primary Prevention of Cardiovascular Disease in Older Patients: A Review of Clinical Guidelines and Updated Evidence

OBJECTIVE: To provide an up-to-date review of current guidelines, previous trials, and new trials regarding aspirin use in primary prevention of cardiovascular (CV) disease in the elderly population. DATA SOURCES: A PubMed search of articles published through April 2019 was performed using a combination of the following words: aspirin, bleeding, cardiovascular, elderly, hemorrhage, myocardial infarction, primary prevention, stroke. STUDY SELECTION/DATA EXTRACTION: Relevant randomized controlled trials, meta-analyses, and guidelines were assessed for the use of aspirin in primary prevention of CV disease in older patients. References from the above literature were also evaluated. Articles were selected for inclusion based on relevance to the topic, detailed methods, and complete results. DATA SYNTHESIS: The role of aspirin for primary prevention of CV disease in older adults is not well defined. As a result, the guideline recommendations for the use of aspirin in this setting are inconsistent. In 2018, the ARRIVE, ASCEND, and ASPREE studies were published. These studies tried to address some of the inconsistencies regarding the use of aspirin in primary prevention of CV disease. This article reviews the current recommendations along with previous and recent studies for aspirin use for primary prevention in older adults. CONCLUSION: The role of aspirin for primary prevention of CV disease in older adults should be individualized based on patient's risk factors, including risk of CV disease and likelihood of bleeding. Updated evidence provides more guidance regarding which patient populations will benefit from therapy.

Changes to the consent process for mandibular third molar surgery

Changes to the delivery of oral surgical services, the production and review of clinical guidelines, increased availability of cross-sectional imaging and the introduction of alternative techniques for surgical management of third molar disease have subtly changed the care that a patient will receive. In reviewing those changes, this article aims to promote continued discussion by the profession as to how patients can be best treated while avoiding a protectionist approach to patient care.