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How Would You Manage This Diabetic Patient With a Foot Infection? Grand Rounds Discussion From Beth Israel Deaconess Medical Center

Foot infections are the most common cause of hospitalization in patients with diabetes. They may be superficial, involving only the skin, or deep, involving the soft tissues or bone. Superficial infections are generally caused by aerobic gram-positive cocci, whereas deep infections, including osteomyelitis, tend to be polymicrobial in origin. Clinical manifestations of skin and soft tissue infections include local evidence of inflammation, but peripheral neuropathy and peripheral artery disease may mask these findings. Management is determined by the extent of infection and often includes oral or parenteral antibiotic therapy in combination with surgical debridement. In 2023, the International Working Group on the Diabetic Foot and the Infectious Diseases Society of America updated their guideline on the diagnosis and management of diabetic foot infection. The guideline includes specific recommendations regarding the use of inflammatory markers, tissue and bone culture, and imaging studies in the diagnosis of diabetic foot infection, as well as the indications for surgical debridement and hospitalization. Here, 2 experts in this field, an infectious diseases physician and a podiatrist, debate how to manage the case of a diabetic patient with foot infection. They discuss diagnostic and treatment challenges in the care of this population.

Protecting the Integrity and Quality of the Medicare Advantage Program: A Position Paper From the American College of Physicians

Medicare Advantage (MA), the private plan option within Medicare, now enrolls more than half of all beneficiaries and is projected to keep expanding. The American College of Physicians (ACP) assesses the ethical and policy dimensions of this growth and its implications for the delivery of fair, high-quality, and fiscally responsible care to older adults and persons with disabilities. Payment and risk adjustment policies have created vulnerabilities to overpayment and favorable risk selection, whereas quality measurement remains fragmented and overly complex. Beneficiaries often face challenges in navigating plan choice, marketing practices, prior authorization, and access to clinicians and postacute services, with these barriers disproportionately affecting persons with low income, persons with several chronic conditions, or persons who live in rural communities. Limited transparency about ownership structures and relationships between insurers, “provider” networks, and investors complicates accountability and public oversight. ACP calls for reforms to ensure accurate payment, streamline and strengthen quality metrics, and protect enrollees from inappropriate utilization controls while supporting innovations that promote coordinated, patient-centered care. Collaborative engagement among policymakers, clinicians, health systems, insurers, and beneficiaries is essential to align MA with its original purpose and ensure that it complements traditional Medicare while providing accessible, affordable, and high-quality coverage for all who depend on it.

New GRADE Evidence-to-Decision Framework for Pairwise and Multiple Comparisons (GRADE Guidance 45)

Evidence-based decision making in health often requires comparison of multiple options for a given condition. The GRADE (Grading of Recommendations Assessment, Development and Evaluation) evidence-to-decision (EtD) framework provides a structured approach for moving from evidence to decisions but was originally designed for pairwise comparisons. Hence, there is a need to accommodate decision making based on multiple comparisons, especially with the increasing use of systematic reviews and network meta-analyses in guideline development. Furthermore, since the original EtD framework was developed, further relevant GRADE guidance has been developed. The aim of this work was to develop a new EtD framework to accommodate multiple comparisons and reflect current GRADE guidance. The new EtD framework was revised and developed through iterative discussion, feedback, and refinement by the GRADE EtD Project Group and the GRADE Working Group. Experiences and examples from guideline developers, methodological experts, and other stakeholders informed improvements in its structure and usability for multiple comparisons and were subsequently approved by the GRADE Working Group. This article describes the new EtD framework, which now includes 2 corresponding parts for reviews of pairwise and multiple comparisons. The authors describe application to a review with multiple comparisons for the different parts of the EtD framework: the question definition, which now includes the presentation of values of health outcomes and decision thresholds; the assessment section, where the new “net effect” criterion has been included; and the conclusion section, which includes an adaptation for multiple comparisons. The article provides examples and suggestions for presentation of findings. The framework does have limitations, in that its usability has not been tested across a broad spectrum of guideline development contexts.

When Would You Screen This 39-Year-Old Woman for Breast Cancer? Grand Rounds Discussion From Beth Israel Deaconess Medical Center

Breast cancer is the second leading cause of cancer death among women in the United States. Screening mammography, which aims to detect asymptomatic breast cancers at earlier and more intervenable stages, has reduced breast cancer mortality, but not overall mortality, in randomized trials. As of 2024, the U.S. Preventive Services Task Force now recommends biennial screening mammography for women aged 40 to 74 years (grade B recommendation). In these rounds, 2 experts, the first a primary care physician and member of the Task Force and the second an epidemiologist and family practitioner, debate this recommendation in the context of Ms. R, a 39-year-old woman. They discuss the benefits and harms of breast cancer screening, the ideal age and frequency at which to conduct screening, and the key points to include when having a conversation with a patient about breast cancer screening.

Principles of Managed Care: A Position Paper From the American College of Physicians

Most U.S. health plans use managed care strategies, including health care use management and clinician networks. Most Medicare, Medicaid, and commercial insurance enrollees are covered by managed care plans. Managed care is ostensibly used to steer patients toward high-quality clinicians and facilities and contain costs; however, prior authorization, narrow clinician networks, and other managed care strategies often restrict access to necessary care, causing frustration among patients and physicians. In this position paper, the American College of Physicians offers policy recommendations to protect patients from onerous managed care processes, reduce administrative burdens associated with managed care, and ensure that patients can promptly access high-value, medically necessary care.

Palliative Care Educational App for Family Caregivers of Homebound Patients With Incurable Cancer: A Single-Center Randomized Trial: Annals of Internal Medicine: Vol 178, No 12

Background: Home-based palliative care relies on empowered family caregivers to overcome the limited availability of palliative care professional resources in managing incurable cancer. Objective: To explore whether adding a palliative care educational app to clinical palliative care could enhance health-related quality of life (HRQoL) in homebound patients with incurable cancer. Design: Single-center, open-label, individual randomized trial. (Chinese Clinical Trial Registry: ChiCTR2300077346) Setting: Single site in Shanghai, China. Participants: Patients with incurable cancer (aged ≥18 years; Karnofsky Performance Status ≤70) receiving palliative care along with consistent family caregivers (aged ≥18 years) enrolled between 28 July and 3 November 2023. Intervention: Patient–caregiver pairs were randomly assigned in a 1:1 ratio to either the intervention group (the app plus palliative care as usual [app]) or the control group (palliative care as usual). The app provided multimedia education on symptom and adverse effect management and nursing information for family caregivers. Measurements: The primary outcome was the mean between-group difference at month 2 in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) score, with the summary score ranging from 0 to 100 and higher scores indicating better outcomes. The primary analysis used the intention-to-treat approach. Results: Of 154 randomly assigned pairs, 147 completed baseline assessments (intervention: n = 74; control: n = 73). The mean age of patients was 59.9 years, and 42.9% were female. At month 2, EORTC QLQ-C30 summary scores were 51.9 (95% CI, 45.4 to 58.5) in the intervention group and 35.7 (CI, 28.6 to 42.9) in the control group, with a mean difference of 16.2 (CI, 9.3 to 23.1). Limitations: Single-center design in China, Chinese-only WeChat app platform, unknown education levels of caregivers and patients, open-label design, and short 2-month follow-up with self-reported outcomes. Conclusion: The palliative care educational app through WeChat improved HRQoL among patients with incurable cancer at 2 months. This finding has implications for future study and development. Primary Funding Source: Shanghai Xingchuan Health Technology Co., Ltd.

How Would You Treat Tricuspid Valve Infective Endocarditis in a Patient Who Uses Injection Drugs? Grand Rounds Discussion From Beth Israel Deaconess Medical Center

Infective endocarditis is a common and morbid condition involving prolonged hospital stays, significant disability, and a high mortality rate. The current crises of injection drug use and opioid use disorder have contributed to high rates of infective endocarditis in the United States. Endocarditis in patients who inject drugs involves additional management complexity for multiple reasons. Several infective endocarditis management guidelines exist, including from the American Heart Association and the European Society of Cardiology. In light of the unique challenges of caring for this particular population, in 2022 the American Heart Association published a scientific statement specifically focusing on infective endocarditis in people who inject drugs. In these rounds, 2 experts in their respective fields, an infectious diseases specialist and a cardiac surgeon, discuss medical management, interventional approaches, and the value of multidisciplinary care for tricuspid valve endocarditis in a person who uses injection drugs, both in general and in relation to Mr. Y, a 30-year-old man with a history of substance use disorder, methicillin-sensitive Staphylococcus aureus bacteremia, and right-sided endocarditis.

Primary Care Physician Time Spent in Patient Care: An Observational Study Using Electronic Health Record Logs

Background: Given a marked expansion in the work of primary care in recent decades, it is critical to have an accurate understanding of the time involved in managing a primary care panel and the determinants of this time. Objective: To estimate the yearly work effort involved for primary care physicians (PCPs) in caring for a patient panel, explore how work effort varies by clinical full-time equivalent (cFTE) status, and identify patient panel factors associated with differential time expenditure. Design: Cross-sectional, observational study using electronic health record and administrative data scaled by a literature-based estimate of activities inadequately captured by these data sources. Setting: 33 clinics in the Mass General Brigham health system. Participants: 406 attending PCPs who delivered care for at least 9 months in 2021. Measurements: Total yearly time expenditure per patient and full-time PCP. Results: The median work effort for a full-time PCP was 2844.3 yearly hours (IQR, 2324.9 to 3478.9 yearly hours), or 61.8 weekly hours (IQR, 50.5 to 75.6 weekly hours), for a 1.0-cFTE physician assuming a 46-week work year. This translates to a median of 1.7 hours (IQR, 1.4 to 2.2 hours) per patient per year. Part-time PCPs spent more time per patient on average than full-time PCPs. Patient medical advice request volume and certain panel characteristics, including greater average age, medical complexity, and percentage of patients with Medicaid, were associated with greater yearly PCP time expenditure per patient. Limitation: Derivation of data from a single integrated health system and lack of information about practice structures and staff supports for PCPs. Conclusion: Primary care physicians spend a median of 62 weekly hours caring for a patient panel. Panel characteristics and patient message volume are associated with time expenditure. These findings provide valuable insights for designing sustainable primary care roles and adjusting panel size expectations. Primary Funding Source: The Physicians Foundation.

Impact of Study Hypotheses on Results From Randomized Clinical Trials: Comparison Between Standard and Noninferiority Randomized Clinical Trials

Background: In embarking on randomized clinical trials (RCTs), researchers can hypothesize that a more intensive treatment is better than a less intensive treatment (positive hypothesis) or that a less intensive treatment is similar or noninferior to a more intensive treatment (negative hypothesis). Researchers may design noninferiority RCTs (NI-RCTs) to support negative hypotheses and standard RCTs (S-RCTs) to support negative or positive hypotheses. Regardless of hypotheses, S-RCTs and NI-RCTs should produce consistent results when assessing similar participants, interventions, control, and outcomes. Objective: To compare effect estimates in S-RCTs with positive hypotheses versus NI-RCTs and in S-RCTs with negative hypotheses versus NI-RCTs. Design: Meta-research. Setting: 98 meta-analyses. Participants: 468 RCTs, including 153 NI-RCTs and 315 S-RCTs (149 positive and 166 negative hypotheses). Intervention: S-RCTs as the exposure and NI-RCTs as the control. Measurements: The ratio of effect estimates between S-RCTs and NI-RCTs in each meta-analysis was combined across meta-analyses. Results: Standard RCTs with positive hypotheses produced effect estimates 1.47 (95% CI, 1.27 to 1.70) times larger than NI-RCTs; among RCTs rated as having low risk of bias for blinding, the ratio was 1.01 (CI, 0.70 to 1.45), whereas among those rated as having high or unclear risk of bias for blinding, the ratio was 1.81 (CI, 1.41 to 2.33). Standard RCTs with negative hypotheses did not produce statistically different effect estimates from NI-RCTs (ratio, 0.93 [CI, 0.84 to 1.03]). Limitation: Findings may be limited by residual differences between S-RCTs and NI-RCTs in the same meta-analysis. Conclusion: The researchers’ hypotheses may bias the results of published RCTs, especially those with high or unclear risk of bias for blinding. The effect of researchers’ hypotheses should be assessed in systematic reviews and clinical practice guidelines when RCTs addressing the same clinical question report conflicting hypotheses. Primary Funding Source: The Shenzhen Municipal Government, Guangdong Province, China, and the Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences.

Lyme Disease

Lyme disease, caused by Borrelia burgdorferi, is the most common vector-borne disease in the United States, and the range of its tick vector continues to expand. Most Lyme disease cases are diagnosed with the onset of the erythema migrans rashes, which can be single or multiple and vary from a homogeneous erythema to bull’s-eye patterns. Serologic antibody testing is of low sensitivity at onset but becomes highly sensitive after a few weeks. Early dissemination may lead to neurologic and cardiac complications. Mono- or oligoarticular arthritis may develop in untreated patients. Antibiotic treatment is highly effective, but approximately 10% of treated patients experience persistent symptoms.