Outpatient Treatment of Confirmed COVID-19: Living, Rapid Practice Points From the American College of Physicians (Version 1).

DESCRIPTION: Strategies to manage COVID-19 in the outpatient setting continue to evolve as new data emerge on SARS-CoV-2 variants and the availability of newer treatments. The Scientific Medical Policy Committee (SMPC) of the American College of Physicians (ACP) developed these living, rapid practice points to summarize the best available evidence on the treatment of adults with confirmed COVID-19 in an outpatient setting. These practice points do not evaluate COVID-19 treatments in the inpatient setting or adjunctive COVID-19 treatments in the outpatient setting. METHODS: The SMPC developed these living, rapid practice points on the basis of a living, rapid review done by the ACP Center for Evidence Reviews at Cochrane Austria at the University for Continuing Education Krems (Danube University Krems). The SMPC will maintain these practice points as living by monitoring and assessing the impact of new evidence. PRACTICE POINT 1: Consider molnupiravir to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting who are within 5 to 7 days of the onset of symptoms and at high risk for progressing to severe disease. PRACTICE POINT 2: Consider nirmatrelvir-ritonavir combination therapy to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting who are within 5 days of the onset of symptoms and at high risk for progressing to severe disease. PRACTICE POINT 3: Consider remdesivir to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting who are within 7 days of the onset of symptoms and at high risk for progressing to severe disease. PRACTICE POINT 4: Do not use azithromycin to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting. PRACTICE POINT 5: Do not use chloroquine or hydroxychloroquine to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting. PRACTICE POINT 6: Do not use ivermectin to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting. PRACTICE POINT 7: Do not use nitazoxanide to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting. PRACTICE POINT 8: Do not use lopinavir-ritonavir combination therapy to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting. PRACTICE POINT 9: Do not use casirivimab-imdevimab combination therapy to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting unless it is considered effective against a SARS-CoV-2 variant or subvariant locally in circulation. PRACTICE POINT 10: Do not use regdanvimab to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting unless it is considered effective against a SARS-CoV-2 variant or subvariant locally in circulation. PRACTICE POINT 11: Do not use sotrovimab to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting unless it is considered effective against a SARS-CoV-2 variant or subvariant locally in circulation. PRACTICE POINT 12: Do not use convalescent plasma to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting. PRACTICE POINT 13: Do not use ciclesonide to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting. PRACTICE POINT 14: Do not use fluvoxamine to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting.

What Is the Antibody Response and Role in Conferring Natural Immunity After SARS-CoV-2 Infection? Rapid, Living Practice Points From the American College of Physicians (Version 2).

DESCRIPTION: The Scientific Medical Policy Committee (SMPC) of the American College of Physicians (ACP) developed these living, rapid practice points to summarize the current best available evidence on the antibody response to SARS-CoV-2 infection and protection against reinfection with SARS-CoV-2. This is version 2 of the ACP practice points, which serves to update version 1, published on 16 March 2021. These practice points do not evaluate vaccine-acquired immunity or cellular immunity. METHODS: The SMPC developed this version of the living, rapid practice points based on an updated living, rapid, systematic review conducted by the Portland VA Research Foundation and funded by the Agency for Healthcare Research and Quality. PRACTICE POINT 1: Do not use SARS-CoV-2 antibody tests for the diagnosis of SARS-CoV-2 infection. PRACTICE POINT 2: Do not use SARS-CoV-2 antibody tests to predict the degree or duration of natural immunity conferred by antibodies against reinfection, including natural immunity against different variants. RETIREMENT FROM LIVING STATUS: Although natural immunity remains a topic of scientific interest, this topic is being retired from living status given the availability of effective vaccines for SARS-CoV-2 and widespread recommendations for and prevalence of their use. Currently, vaccination is the best clinical recommendation for preventing infection, reinfection, and serious illness from SARS-CoV-2 and its variants.

The Development of Living, Rapid Practice Points: Summary of Methods From the Scientific Medical Policy Committee of the American College of Physicians.

In response to the COVID-19 pandemic, the Scientific Medical Policy Committee (SMPC) of the American College of Physicians (ACP) began developing "practice points" to provide clinical advice based on the best available evidence for the public, patients, clinicians, and public health professionals. As one of the first organizations in the United States to develop evidence-based clinical guidelines, ACP continues to lead and advance the science of evidence-based medicine by implementing new methods to rapidly publish practice points and maintain them as living advice that regularly assesses and incorporates new evidence. The overarching aim of practice points is to answer targeted key questions for which there is a timely need to synthesize evidence for decision making. The SMPC believes these methods can potentially be adapted to address various clinical and public health topics beyond the COVID-19 pandemic. This article presents an overview of the SMPC's living, rapid practice points development process, which includes a rapid systematic review, use of the GRADE (Grading of Recommendations Assessment, Development and Evaluation) method, use of stringent policies on the disclosure of interests and management of conflicts of interest, incorporating a public (nonclinician) perspective, and maintenance of the documents as living through ongoing surveillance and synthesis of new evidence as it emerges.

Appropriate Use of Short-Course Antibiotics in Common Infections: Best Practice Advice From the American College of Physicians.

DESCRIPTION: Antimicrobial overuse is a major health care issue that contributes to antibiotic resistance. Such overuse includes unnecessarily long durations of antibiotic therapy in patients with common bacterial infections, such as acute bronchitis with chronic obstructive pulmonary disease (COPD) exacerbation, community-acquired pneumonia (CAP), urinary tract infections (UTIs), and cellulitis. This article describes best practices for prescribing appropriate and short-duration antibiotic therapy for patients presenting with these infections. METHODS: The authors conducted a narrative literature review of published clinical guidelines, systematic reviews, and individual studies that addressed bronchitis with COPD exacerbations, CAP, UTIs, and cellulitis. This article is based on the best available evidence but was not a formal systematic review. Guidance was prioritized to the highest available level of synthesized evidence. BEST PRACTICE ADVICE 1: Clinicians should limit antibiotic treatment duration to 5 days when managing patients with COPD exacerbations and acute uncomplicated bronchitis who have clinical signs of a bacterial infection (presence of increased sputum purulence in addition to increased dyspnea, and/or increased sputum volume). BEST PRACTICE ADVICE 2: Clinicians should prescribe antibiotics for community-acquired pneumonia for a minimum of 5 days. Extension of therapy after 5 days of antibiotics should be guided by validated measures of clinical stability, which include resolution of vital sign abnormalities, ability to eat, and normal mentation. BEST PRACTICE ADVICE 3: In women with uncomplicated bacterial cystitis, clinicians should prescribe short-course antibiotics with either nitrofurantoin for 5 days, trimethoprim-sulfamethoxazole (TMP-SMZ) for 3 days, or fosfomycin as a single dose. In men and women with uncomplicated pyelonephritis, clinicians should prescribe short-course therapy either with fluoroquinolones (5 to 7 days) or TMP-SMZ (14 days) based on antibiotic susceptibility. BEST PRACTICE ADVICE 4: In patients with nonpurulent cellulitis, clinicians should use a 5- to 6-day course of antibiotics active against streptococci, particularly for patients able to self-monitor and who have close follow-up with primary care.

What Is the Antibody Response and Role in Conferring Natural Immunity After SARS-CoV-2 Infection? Rapid, Living Practice Points From the American College of Physicians (Version 1).

DESCRIPTION: The widespread availability of SARS-CoV-2 antibody tests raises important questions for clinicians, patients, and public health professionals related to the appropriate use and interpretation of these tests. The Scientific Medical Policy Committee (SMPC) of the American College of Physicians developed these rapid, living practice points to summarize the current and best available evidence on the antibody response to SARS-CoV-2 infection, antibody durability after initial infection with SARS-CoV-2, and antibody protection against reinfection with SARS-CoV-2. METHODS: The SMPC developed these rapid, living practice points based on a rapid and living systematic evidence review done by the Portland VA Research Foundation and funded by the Agency for Healthcare Research and Quality. Ongoing literature surveillance is planned through December 2021. When new studies are identified and a full update of the evidence review is published, the SMPC will assess the new evidence and any effect on the practice points. PRACTICE POINT 1: Do not use SARS-CoV-2 antibody tests for the diagnosis of SARS-CoV-2 infection. PRACTICE POINT 2: Antibody tests can be useful for the purpose of estimating community prevalence of SARS-CoV-2 infection. PRACTICE POINT 3: Current evidence is uncertain to predict presence, level, or durability of natural immunity conferred by SARS-CoV-2 antibodies against reinfection (after SARS-CoV-2 infection).

Nonpharmacologic and Pharmacologic Management of Acute Pain From Non-Low Back, Musculoskeletal Injuries in Adults: A Clinical Guideline From the American College of Physicians and American Academy of Family Physicians.

DESCRIPTION: The American College of Physicians (ACP) and American Academy of Family Physicians (AAFP) developed this guideline to provide clinical recommendations on nonpharmacologic and pharmacologic management of acute pain from non-low back, musculoskeletal injuries in adults in the outpatient setting. The guidance is based on current best available evidence about benefits and harms, taken in the context of costs and patient values and preferences. This guideline does not address noninvasive treatment of low back pain, which is covered by a separate ACP guideline that has also been endorsed by AAFP. METHODS: This guideline is based on a systematic evidence review on the comparative efficacy and safety of nonpharmacologic and pharmacologic management of acute pain from non-low back, musculoskeletal injuries in adults in the outpatient setting and a systematic review on the predictors of prolonged opioid use. We evaluated the following clinical outcomes using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system: pain (at ≤2 hours and at 1 to 7 days), physical function, symptom relief, treatment satisfaction, and adverse events. TARGET AUDIENCE AND PATIENT POPULATION: The target audience is all clinicians, and the target patient population is adults with acute pain from non-low back, musculoskeletal injuries. RECOMMENDATION 1: ACP and AAFP recommend that clinicians treat patients with acute pain from non-low back, musculoskeletal injuries with topical nonsteroidal anti-inflammatory drugs (NSAIDs) with or without menthol gel as first-line therapy to reduce or relieve symptoms, including pain; improve physical function; and improve the patient's treatment satisfaction (Grade: strong recommendation; moderate-certainty evidence). RECOMMENDATION 2A: ACP and AAFP suggest that clinicians treat patients with acute pain from non-low back, musculoskeletal injuries with oral NSAIDs to reduce or relieve symptoms, including pain, and to improve physical function, or with oral acetaminophen to reduce pain (Grade: conditional recommendation; moderate-certainty evidence). RECOMMENDATION 2B: ACP and AAFP suggest that clinicians treat patients with acute pain from non-low back, musculoskeletal injuries with specific acupressure to reduce pain and improve physical function, or with transcutaneous electrical nerve stimulation to reduce pain (Grade: conditional recommendation; low-certainty evidence). RECOMMENDATION 3: ACP and AAFP suggest against clinicians treating patients with acute pain from non-low back, musculoskeletal injuries with opioids, including tramadol (Grade: conditional recommendation; low-certainty evidence).

Critical Workforce Gaps in Dementia Education and Training.

The US Department of Health and Human Services and the Foundation for the National Institutes of Health, through private sector support, sponsored the National Research Summit on Dementia Care: Building Evidence for Services and Supports (Summit) in 2017. Various workgroups were asked to address topics of interest in dementia care and develop recommendations addressing the goals of the Summit. Workforce education and training was identified to be a key issue. As a result, a Workforce Development Workgroup (the Workgroup) was created and addressed two of the Summit's goals. The first goal is to improve the quality of care and support provided to persons living with dementia and those who care for them. The second goal is to accelerate the development, evaluation, translation, implementation, and scaling-up of evidence-based and evidence-informed services for persons living with dementia, their families, and caregivers. In this article, the Workgroup identified gaps in educating and training a dementia-capable workforce. The Workgroup consisted of an interprofessional team with expertise in dementia workforce development from academia, professional organizations, and the federal government. Four recommendations are presented concerning research topics that will advance the education and training of a dementia-capable workforce, which includes health professions students, faculty, practitioners, direct care workers, persons living with dementia, and those who care for them. J Am Geriatr Soc 68:625-629, 2020.

Testosterone Treatment in Adult Men With Age-Related Low Testosterone: A Clinical Guideline From the American College of Physicians.

Description: The American College of Physicians (ACP) developed this guideline to provide clinical recommendations based on the current evidence of the benefits and harms of testosterone treatment in adult men with age-related low testosterone. This guideline is endorsed by the American Academy of Family Physicians. Methods: The ACP Clinical Guidelines Committee based these recommendations on a systematic review on the efficacy and safety of testosterone treatment in adult men with age-related low testosterone. Clinical outcomes were evaluated by using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system and included sexual function, physical function, quality of life, energy and vitality, depression, cognition, serious adverse events, major adverse cardiovascular events, and other adverse events. Target Audience and Patient Population: The target audience includes all clinicians, and the target patient population includes adult men with age-related low testosterone. Recommendation 1a: ACP suggests that clinicians discuss whether to initiate testosterone treatment in men with age-related low testosterone with sexual dysfunction who want to improve sexual function (conditional recommendation; low-certainty evidence). The discussion should include the potential benefits, harms, costs, and patient's preferences. Recommendation 1b: ACP suggests that clinicians should reevaluate symptoms within 12 months and periodically thereafter. Clinicians should discontinue testosterone treatment in men with age-related low testosterone with sexual dysfunction in whom there is no improvement in sexual function (conditional recommendation; low-certainty evidence). Recommendation 1c: ACP suggests that clinicians consider intramuscular rather than transdermal formulations when initiating testosterone treatment to improve sexual function in men with age-related low testosterone, as costs are considerably lower for the intramuscular formulation and clinical effectiveness and harms are similar. Recommendation 2: ACP suggests that clinicians not initiate testosterone treatment in men with age-related low testosterone to improve energy, vitality, physical function, or cognition (conditional recommendation; low-certainty evidence).

Screening for Colorectal Cancer in Asymptomatic Average-Risk Adults: A Guidance Statement From the American College of Physicians.

Description: The purpose of this guidance statement is to guide clinicians on colorectal cancer screening in average-risk adults. Methods: This guidance statement is derived from a critical appraisal of guidelines on screening for colorectal cancer in average-risk adults and the evidence presented in these guidelines. National guidelines published in English between 1 June 2014 and 28 May 2018 in the National Guideline Clearinghouse or Guidelines International Network library were included. The authors also included 3 guidelines commonly used in clinical practice. Web sites were searched for guideline updates in December 2018. The AGREE II (Appraisal of Guidelines for Research and Evaluation II) instrument was used to evaluate the quality of guidelines. Target Audience and Patient Population: The target audience is all clinicians, and the target patient population is adults at average risk for colorectal cancer. Guidance Statement 1: Clinicians should screen for colorectal cancer in average-risk adults between the ages of 50 and 75 years. Guidance Statement 2: Clinicians should select the colorectal cancer screening test with the patient on the basis of a discussion of benefits, harms, costs, availability, frequency, and patient preferences. Suggested screening tests and intervals are fecal immunochemical testing or high-sensitivity guaiac-based fecal occult blood testing every 2 years, colonoscopy every 10 years, or flexible sigmoidoscopy every 10 years plus fecal immunochemical testing every 2 years. Guidance Statement 3: Clinicians should discontinue screening for colorectal cancer in average-risk adults older than 75 years or in adults with a life expectancy of 10 years or less.

Disclosure of Interests and Management of Conflicts of Interest in Clinical Guidelines and Guidance Statements: Methods From the Clinical Guidelines Committee of the American College of Physicians.

One of the hallmarks of a trustworthy clinical guideline or guidance statement is a comprehensive process for disclosure of interests (DOI) and management of conflicts of interest (COIs). The American College of Physicians (ACP) Clinical Guidelines Committee (CGC) aims to disclose all health care-related interests and manage conflicts in a manner that is transparent, proportional, and consistent. Any person involved in the development of an ACP clinical guideline or guidance statement must disclose all financial and intellectual interests related to health care from the previous 3 years. Persons complete disclosures at the start of their participation and are required to update them over the course of their involvement with the CGC, including before each CGC meeting. A DOI-COI Review and Management Panel reviews the disclosures; flags potential conflicts; grades the COI as low-, moderate-, or high-level; and manages the person's participation accordingly. A high-level COI results in recusal from authorship, voting, and all committee discussions. Participants with a moderate-level COI are recused from authorship and voting for clinically relevant topics but may participate in all discussions. A low-level COI results in no role restrictions. All disclosures and COI management decisions are publicly reported.

The Development of Clinical Guidelines and Guidance Statements by the Clinical Guidelines Committee of the American College of Physicians: Update of Methods.

The American College of Physicians (ACP) was one of the first organizations in the United States to develop evidence-based clinical guidelines and has been developing guidelines since 1981. ACP's Clinical Guidelines Committee (CGC), in collaboration with staff from the Clinical Policy department, develops clinical guidelines and guidance statements and continues to refine and enhance its methodology. This article presents an update of the CGC's 2010 paper outlining policies, methods, and presentation format of ACP's clinical guidelines and guidance statements. Updated methods include more stringent policies about disclosure of interests and conflict management; inclusion of public perspective; full adoption of GRADE (Grading of Recommendations Assessment, Development and Evaluation) methods; more standardized reporting formats that consider value of care, patient comorbid conditions, patient values and preferences, and costs; and further clarification of guidance statement methods.

Screening for Breast Cancer in Average-Risk Women: A Guidance Statement From the American College of Physicians.

Description: The purpose of this guidance statement is to provide advice to clinicians on breast cancer screening in average-risk women based on a review of existing guidelines and the evidence they include. Methods: This guidance statement is derived from an appraisal of selected guidelines from around the world that address breast cancer screening, as well as their included evidence. All national guidelines published in English between 1 January 2013 and 15 November 2017 in the National Guideline Clearinghouse or Guidelines International Network library were included. In addition, the authors selected other guidelines commonly used in clinical practice. Web sites associated with all selected guidelines were checked for updates on 10 December 2018. The AGREE II (Appraisal of Guidelines for Research and Evaluation II) instrument was used to evaluate the quality of guidelines. Target Audience and Patient Population: The target audience is all clinicians, and the target patient population is all asymptomatic women with average risk for breast cancer. Guidance Statement 1: In average-risk women aged 40 to 49 years, clinicians should discuss whether to screen for breast cancer with mammography before age 50 years. Discussion should include the potential benefits and harms and a woman's preferences. The potential harms outweigh the benefits in most women aged 40 to 49 years. Guidance Statement 2: In average-risk women aged 50 to 74 years, clinicians should offer screening for breast cancer with biennial mammography. Guidance Statement 3: In average-risk women aged 75 years or older or in women with a life expectancy of 10 years or less, clinicians should discontinue screening for breast cancer. Guidance Statement 4: In average-risk women of all ages, clinicians should not use clinical breast examination to screen for breast cancer.