Practice Guideline Update Research Articles

Potentially Curable Pancreatic Adenocarcinoma: ASCO Clinical Practice Guideline Update.

The purpose of this guideline update is to incorporate recently reported practice-changing evidence into ASCO's recommendations on potentially curable pancreatic adenocarcinoma. ASCO convened an Expert Panel to evaluate data from PRODIGE 24/CCTG PA.6, a phase III, multicenter, randomized clinical trial of postoperative leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin (FOLFIRINOX) versus gemcitabine alone, presented at the 2018 ASCO Annual Meeting. In addition, PubMed was searched for additional papers that may influence the existing recommendations. The Expert Panel only updated Recommendation 4.1 as a result of the practice-changing data. Recommendation 4.1 states that all patients with resected pancreatic adenocarcinoma who did not receive preoperative therapy should be offered 6 months of adjuvant chemotherapy in the absence of medical or surgical contraindications. The modified combination regimen of 5-fluorouracil, oxaliplatin, and irinotecan (mFOLFIRINOX; oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, irinotecan 150 mg/m2 D1, and 5-fluorouracil 2.4 g/m2 over 46 hours every 14 days for 12 cycles) is now preferred in the absence of concerns for toxicity or tolerance; alternatively, doublet therapy with gemcitabine and capecitabine or monotherapy with gemcitabine alone or fluorouracil plus folinic acid alone can be offered.Additional information can be found at www.asco.org/gastrointestinal-cancer-guidelines.

Author response: Practice guideline update recommendations summary: Disorders of consciousness: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology; the American Congress of Rehabilitation Medicine; and the National Institute on Disability, Independent Living, and Rehabilitation Research.

American Academy of Neurology (AAN) guidelines comply with the AAN Institute Board-approved guideline methodology referenced within the systematic review/guideline.1,2 Compliance is ensured by a methodologist working on each project and multiple rounds of AAN Guideline Development, Dissemination, and Implementation Subcommittee review. We believe that Phan et al. are referencing the 2004 recommendation methodology.3 The disorders of consciousness guideline used the 2011 AAN guideline manual, as amended,4 based on 2011 Institute of Medicine (IOM) standards for evidence-based guidelines.

Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: ASCO Clinical Practice Guideline Update—Integration of Results From TAILORx

This focused update addresses the use of Oncotype DX in guiding decisions on the use of adjuvant systemic therapy. ASCO uses a signals approach to facilitate guideline updating. For this focused update, the publication of the Trial Assigning Individualized Options for Treatment (TAILORx) evaluating noninferiority of endocrine therapy alone versus chemoendocrine therapy for invasive disease-free survival in women with Oncotype DX scores provided a signal. An expert panel reviewed the results of TAILORx along with other published literature on the Oncotype DX assay to assess for evidence of clinical utility. For patients with hormone receptor-positive, axillary node-negative breast cancer whose tumors have Oncotype DX recurrence scores of less than 26, there is little to no benefit from chemotherapy, especially for patients older than age 50 years. Clinicians may recommend endocrine therapy alone for women older than age 50 years. For patients 50 years of age or younger with recurrence scores of 16 to 25, clinicians may offer chemoendocrine therapy. Patients with recurrence scores greater than 30 should be considered candidates for chemoendocrine therapy. Based on informal consensus, the panel recommends that oncologists may offer chemoendocrine therapy to these patients with recurrence scores of 26 to 30. Additional information can be found at www.asco.org/breast-cancer-guidelines.

In older postmenopausal women with osteopenia, zoledronate reduced fragility fractures at 6 years.

ACP Journal Club16 April 2019In older postmenopausal women with osteopenia, zoledronate reduced fragility fractures at 6 yearsKristine E. Ensrud, MD, MPH, MACP, Carolyn J. Crandall, MD, MS, FACPKristine E. Ensrud, MD, MPH, MACPUniversity of Minnesota and, Minneapolis Veterans Affairs Health Care System, Minneapolis, Minnesota, USA (K.E.E.)Search for more papers by this author, Carolyn J. Crandall, MD, MS, FACPUniversity of California, Los Angeles, California, USA (C.J.C.)Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/ACPJ201904160-042 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Source CitationReid IR, Horne AM, Mihov B, et al. Fracture prevention with zoledronate in older women with osteopenia. N Engl J Med. 2018;379:2407-16. https://pubmed.ncbi.nlm.nih.gov/30575489Clinical Impact RatingsGIM/FP/GP: Endocrinology: Geriatrics: References1 Cummings SR, Black DM, Thompson DE, et al. Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: results from the Fracture Intervention Trial. JAMA. 1998;280:2077-82. [PMID: 9875874] Google Scholar2 Black DM, Delmas PD, Eastell R, et al; HORIZON Pivotal Fracture Trial. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med. 2007;356:1809-22. [PMID: 17476007] Google Scholar3 Gedmintas L, Solomon DH, Kim SC. Bisphosphonates and risk of subtrochanteric femoral shaft, and atypical femur fracture: a systematic review and meta-analysis. J Bone Miner Res. 2013;28:1729-37. [PMID: 23408697] Google Scholar4 Black DM, Geiger EJ, Li BH, et al. Bisphosphonate use and risk of AFF varies by pre-treatment BMD level: results from the Southern California Osteoporosis Cohort Study (SOCS). J Bone Miner Res. 2018;33(Suppl 1):2 (abstract no. 1007). www.asbmr.org/education/AbstractDetail?aid=94cf315c-de77-4e44-bbf3-acde8c9749fb (accessed 11 Feb 2019). Google Scholar5 Solomon DH, Johnston SS, Boytsov NN, et al. Osteoporosis medication use after hip fracture in U.S. patients between 2002 and 2011. J Bone Miner Res. 2014;29:1929-37. [PMID: 24535775] Google Scholar6 Qaseem A, Forciea MA, McLean RM, Denberg TD, Clinical Guidelines Committee of the American College of Physicians. Treatment of low bone density or osteoporosis to prevent fractures in men and women: a clinical practice guideline update from the American College of Physicians. Ann Intern Med. 2017;166:818-39. [PMID: 28492856] Google Scholar Author, Article, and Disclosure InformationAffiliations: University of Minnesota and, Minneapolis Veterans Affairs Health Care System, Minneapolis, Minnesota, USA (K.E.E.)University of California, Los Angeles, California, USA (C.J.C.)This article was published at Annals.org on 2 April 2019. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics 16 April 2019Volume 170, Issue 8Page: JC42KeywordsBone mineral densityDrugsHip fracturesNumber needed to treatOdds ratioOsteopeniaOsteoporosisResearch fundingSerious adverse eventsSystemic diseases ePublished: 16 April 2019 Issue Published: 16 April 2019 Copyright & PermissionsCopyright © 2019 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...

Practice guideline update summary: Efficacy and tolerability of the new antiepileptic drugs II: Treatment-resistant epilepsy: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology and the American Epilepsy Society.

In the article “Generalized polyspike train: An EEG biomarker of drug-resistant idiopathic generalized epilepsy” by Sun et al.,1 one author's name should read as Kee Meng Tan. The authors regret the errors.

ASCO Guideline report: Palliative Care in the Global Setting—ASCO Resource-Stratified Practice Guideline.

85 Background: The purpose of the new ASCO resource-stratified guideline on global palliative care (Osman H, Shrestha S, Temin S, et al, Palliative Care in the Global Setting: ASCO Resource-Stratified Practice Guideline, JGO, 2018) is to provide expert guidance to clinicians and policymakers on implementing palliative care in resource-constrained settings and was intended to complement the 2016 “Integration of Palliative Care Into Standard Oncology Care: American Society of Clinical Oncology Clinical Practice Guideline Update”. Methods: ASCO convened a multidisciplinary, multinational panel of experts. Guideline development involved a systematic review, a modified ADAPTE process of existing high-quality guidelines and a formal consensus-based process with the expert panel and additional experts (consensus ratings group), as well as open comment. Results: The systematic review included 48 full-text publications regarding palliative care in resource-constrained settings, along with cost-effectiveness analyses; the evidence for many clinical questions was limited. These provided indirect evidence to inform the formal consensus process, which resulted in agreement of ≥ 75% (by consensus ratings group including expert panel). Conclusions: The recommendations help define: the models of care, staffing requirements, and roles and training needs of team members in a variety of resource settings for palliative care. Recommendations also outline the standards for provision of psychosocial support, spiritual care, and opioid analgesics, which can be particularly challenging and often overlooked in resource-constrained settings.

1289. Knowledge, Attitudes and Barriers of Pre-exposure Prophylaxis for HIV Infection Among Resident Physicians in Rural, Eastern North Carolina

BackgroundNorth Carolina bears a high burden of HIV and was ranked number 8 for the number of new infections in 2015. In 2014, the Centers for Disease Control and Prevention (CDC) published updated practice guidelines recommending the use of pre-exposure prophylaxis (PrEP) with daily oral dosing of tenofovir/emtricitabine to help prevent HIV infection in high-risk individuals. However, the use of PrEP in the primary care setting remains low and 1 in three primary care physicians is not aware of PrEP. The objective of our study was to evaluate PrEP knowledge among primary care resident physicians.Methods149 resident physicians were surveyed at East Carolina University from the following specialties; Internal Medicine, Medicine-Pediatrics, Obstetrics Gynecology and Family Medicine. We collected participants’ age, biological sex, current residency program, and current year within the residency program.ResultsSixty out 149 residents completed the online survey. 20% of residents had never heard of PrEP. 17% of residents did not feel comfortable discussing sexual preferences with their patients. 15% of residents thought prescribing would increase risky sexual behaviors and 12% would not prescribe PrEP to patients with multiple sexual partners. Only 3% of residents identified potential side effects of PrEP (e.g., an increase in creatinine levels or decrease in mineral bone density) as a reason to not prescribe PrEP. One resident had ever prescribed PrEP. 83% of residents wanted more information on PrEP and 95% of residents would be willing to prescribe PrEP if educational workshops were offered.ConclusionPrEP is an underutilized tool among resident physicians in Eastern, NC. We identified lack of knowledge of PrEP and concern for increased risky sexual behaviors as barriers to prescribing. Resident physicians require more education on PrEP in order to prescribe it to their patients.Disclosures All authors: No reported disclosures.

Automated quality control process for tracking appropriateness of antiemesis.

317 Background: Quality tracking and improvement are areas of importance for delivery of high value patient care. Quality Oncology Practice Initiatives (QOPI) are tools designed by ASCO to help oncology practices deliver high quality care. Specifically, QOPI measure 29 tracks whether antiemetics are administered appropriately with moderate/high emetic risk chemotherapy. In this study, we attempted to automate this quality measure using an adapted Microsoft Structured Query Language (SQL) procedure. Our primary aim was to develop an efficient and cost effective system to track appropriate anti emesis that is adaptable to other cancer centers. A secondary aim was to quantify any degree of over treatment in anti emesis in our center. Methods: We created an SQL procedure which accessed the EPIC CLARITY database and used 9 steps to identify how many chemotherapy administrations in our center for the year 2017 were given sufficient, over, or under anti emesis. We adapted our center’s antiemesis guidelines from 2017 ASCO Clinical Practice Guideline Update for antiemetics. The program identified “pass”/”fail”/”pass(-)” for appropriate/insufficient/over treatment of anti emesis, respectively. Results: 1490 patient/chemotherapy encounters were found for 2017. 862/118/510 were high/intermediate/low emetic risk, respectively. 1314/14/162 chemotherapy administrations received “pass”/”fail”/”pass (-)”, respectively. The reason for 13 of 14 “fails” was lack of steroid in high emetic risk regimens. The primary reason for “pass (-)” was use of fosaprepitant in low/intermediate risk regimens. The time required to execute the program for all 1490 encounters was 40 seconds; the average time for manual review was 3 minutes per encounter. There was no discordance between “pass/fail” status in comparing automated and manual reviews. Conclusions: We have created an automated process which rapidly and accurately verifies adherence to QOPI measure 29. It eliminates time and costs associated with manual review. Further, this program saves costs by identifying areas of over treatment in anti emesis. We have demonstrated on a large scale an adaptable and shareable process for other centers using similar EMR databases.

The Role of Completion Lymph Node Dissection for Sentinel Lymph Node-Positive Melanoma.

Completion lymph node dissection (CLND) for sentinel lymph node (SLN)-positive melanoma patients has been guideline-concordant standard of care since adoption of lymphatic mapping and SLN biopsy for the management of clinically node-negative melanoma patients more than 20years ago. However, a trend for omission of CLND has been observed over the past decade, and we now have randomized, controlled clinical trial data to help guide treatment recommendations. Publication of these data prompted an American Society of Clinical Oncology-Society of Surgical Oncology 2018 clinical practice guideline update for these patients. Systematic review of current evidence supports a selective, individualized approach to CLND for SLN-positive melanoma. For low-risk, low-volume micrometastatic disease, SLN biopsy may be both diagnostic and therapeutic, and close clinical follow-up with imaging or CLND are reasonable options for appropriately selected patients. For higher-risk patients, omission of CLND requires careful consideration of risks versus benefits, relevant histopathology, and individualized patient discussion. This should address patient comorbidities and life expectancy, the predicted likelihood of additional positive nodes, availability of imaging surveillance, likelihood of adherence to imaging and clinical follow-up, consequences of regional recurrence, and the prognostic value of complete nodal staging and its impact on adjuvant therapy recommendations or clinical trial participation. Data on long-term outcomes, cost, and patient-reported quality of life measures are not yet available.

Congenital Adrenal Hyperplasia Due to Steroid 21-Hydroxylase Deficiency: An Endocrine Society Clinical Practice Guideline.

To update the congenital adrenal hyperplasia due to steroid 21-hydroxylase deficiency clinical practice guideline published by the Endocrine Society in 2010. The writing committee presents updated best practice guidelines for the clinical management of congenital adrenal hyperplasia based on published evidence and expert opinion with added considerations for patient safety, quality of life, cost, and utilization.

Renal association commentary on the KDIGO (2017) clinical practice guideline update for the diagnosis, evaluation, prevention, and treatment of CKD-MBD

This report comments on the relevance and utility of the recently published (2017) KDIGO Clinical Practice Guideline Update for the diagnosis, evaluation, prevention and treatment of mineral bone disease in patients with chronic kidney disease (CKD-MBD) with respect to UK clinical practice. This document replaces all previously published Renal Association guidelines on the topic.

Antimicrobial Prophylaxis for Adult Patients With Cancer-Related Immunosuppression: ASCO and IDSA Clinical Practice Guideline Update

To provide an updated joint ASCO/Infectious Diseases Society of America (IDSA) guideline on antimicrobial prophylaxis for adult patients with immunosuppression associated with cancer and its treatment. ASCO and IDSA convened an update Expert Panel and conducted a systematic review of relevant studies from May 2011 to November 2016. The guideline recommendations were based on the review of evidence by the Expert Panel. Six new or updated meta-analyses and six new primary studies were added to the updated systematic review. Antibacterial and antifungal prophylaxis is recommended for patients who are at high risk of infection, including patients who are expected to have profound, protracted neutropenia, which is defined as < 100 neutrophils/µL for > 7 days or other risk factors. Herpes simplex virus-seropositive patients undergoing allogeneic hematopoietic stem-cell transplantation or leukemia induction therapy should receive nucleoside analog-based antiviral prophylaxis, such as acyclovir. Pneumocystis jirovecii prophylaxis is recommended for patients receiving chemotherapy regimens that are associated with a > 3.5% risk for pneumonia as a result of this organism (eg, those with ≥ 20 mg prednisone equivalents daily for ≥ 1 month or on the basis of purine analog usage). Treatment with a nucleoside reverse transcription inhibitor (eg, entecavir or tenofovir) is recommended for patients at high risk of hepatitis B virus reactivation. Recommendations for vaccination and avoidance of prolonged contact with environments that have high concentrations of airborne fungal spores are also provided within the updated guideline. Additional information is available at www.asco.org/supportive-care-guidelines .

Antimicrobial Prophylaxis for Adult Patients With Cancer-Related Immunosuppression: ASCO and IDSA Clinical Practice Guideline Update Summary.

Antimicrobial Prophylaxis for Adult Patients With Cancer-Related Immunosuppression: ASCO and IDSA Clinical Practice Guideline Update Summary.

Reader response: Practice guideline update summary: Mild cognitive impairment: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology

We have some concerns about the recommendations on cholinesterase inhibitors in the recent guidelines on mild cognitive impairment (MCI).1 Evidence in the guidelines, and in systematic reviews,2–4 clearly shows that cholinesterase inhibitors have no reliable benefit on cognition and do not reduce progression to dementia. At the same time, patients are exposed to risk: “side effects… are common, including gastrointestinal symptoms and cardiac concerns.”1 It is, therefore, curious that the message to practitioners is equivocal. They “may choose” not to use these medicines (recommendation B3a), or choose to actively prescribe them after “first discuss[ing] with the patient the fact this is…not currently backed by empirical evidence” (recommendation B3b).1 This is the first instance we recall of a learned academy legitimizing prescription of a class of drugs recognized to be ineffective. Given the guidelines' potential for influence, we are deeply concerned that patients—who often are ill-equipped to make judgments of this kind—may be unnecessarily exposed to harm, and health care systems to needless cost. More generally, we are anxious to avoid a precedent for evidence being viewed as “optional” in clinical decision-making. We call upon the American Academy of Neurology and authors to retract recommendation B3b and rewrite B3a to plainly recommend against use of cholinesterase inhibitors in MCI.

Editors' note: Practice guideline update summary: Mild cognitive impairment: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology

In response to the updated American Academy of Neurology (AAN) guidelines on mild cognitive impairment (MCI), Drs. Wang and Cui ask whether different subtypes of MCI show differences in clinical presentation that could allow for earlier prognosis. They also inquire whether more detailed recommendations on nonpharmacologic treatments in MCI, such as Tai Chi Chuan, were available. Finally, they comment that the utility of biomarkers in MCI remains uncertain. Authors Petersen et al. agree that predicting the patients with MCI who will revert to normal or remain stable is of high interest and that there are no accepted biomarkers currently. Drs. Valenzuela et al. express concern that the guidelines propose cholinesterase inhibitor treatment to be optional despite no proven benefit and the possibility of side effects. The authors explain that the wording of the recommendations reflected that some studies reviewed could not exclude a beneficial effect of cholinesterase inhibitors on MCI outcomes. They maintain that specific patient encounters should be directed by shared, informed decision-making and not guidelines. Dr. Braillon praises the AAN's updated MCI guidelines and critiques several European publications for including, in his opinion, incorrect and outdated information in their MCI recommendations. The authors express hope that the new guidelines raise awareness on several key issues regarding MCI risk factors and treatments. In response to the updated American Academy of Neurology (AAN) guidelines on mild cognitive impairment (MCI), Drs. Wang and Cui ask whether different subtypes of MCI show differences in clinical presentation that could allow for earlier prognosis. They also inquire whether more detailed recommendations on nonpharmacologic treatments in MCI, such as Tai Chi Chuan, were available.

Reader response: Practice guideline update summary: Mild cognitive impairment: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology.

The Academy must be commended for its update summary on mild cognitive impairment (MCI).1 Petersen et al.1 utilized the robust methodology of evidence classification criteria and recommendations were graded and clear to the reader: “Clinicians may choose not to offer cholinesterase inhibitors (Level B); if offering, they must first discuss lack of evidence (Level A).”

Author response: Practice guideline update summary: Mild cognitive impairment: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology.

Author response: Practice guideline update summary: Mild cognitive impairment: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology.

Reader response: Practice guideline update summary: Mild cognitive impairment: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology.

The updated American Academy of Neurology guidelines on mild cognitive impairment (MCI) are essential both for clinical and research settings.1 Dramatic changes in the definition of MCI over recent decades require a more dynamic and on-limits attitude towards newly proposed diagnostic and treating methods, which leads to a few concerns that demand further explanation.

Generating evidence to inform an update of asthma clinical practice guidelines: Perspectives from the National Heart, Lung, and Blood Institute

Asthma is the most prevalent chronic respiratory disease worldwide. Its increasing prevalence and evidence of suboptimal control require renewed efforts in the development and widespread implementation of clinical practice guidelines for prevention, treatment, and control. Given the rapidly changing landscape and evolving best practices for guideline development, the National Heart, Lung, and Blood Institute made a commitment to support rigorous systematic evidence reviews that frontline health care providers and stakeholders could use to create new or update existing guidelines. This article describes the protocols, key questions, methodology, and analytic framework to support the update of the 2007 National Asthma Education and Prevention Program Expert Panel Report 3 (EPR-3) on the diagnosis and management of asthma in adults and children. It also describes the expert panel's practical experience in managing asthmatic patients across the age and severity spectrum. The article explains the process for ensuring that the expert panel's deliberations are conducted in accordance with the Institute of Medicine's standards and recommendations for guideline development. The outcome of this ambitious effort will be an update of the EPR-3 asthma guidelines and publication of the key recommendations in the Journal of Allergy and Clinical Immunology. Importantly, several novel approaches will be explored and incorporated as appropriate to accelerate adoption and sustained implementation of the guidelines.

Recommendations on Disease Management for Patients With Advanced Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer and Brain Metastases: ASCO Clinical Practice Guideline Update Summary.

Recommendations on Disease Management for Patients With Advanced Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer and Brain Metastases: ASCO Clinical Practice Guideline Update Summary.