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Introduction: Accurate, patient-centred evaluation of physical function in patients with cancer can provide important information on the functional impacts experienced by patients both from the disease and its treatment. Increasingly, digital health technology is facilitating and providing new ways to measure symptoms and function. There is a need to characterise the longitudinal measurement characteristics of physical function assessments, including clinician-reported outcome, patient-reported ported outcome (PRO), performance outcome tests and wearable data, to inform regulatory and clinical decision-making in cancer clinical trials and oncology practice., Methods and Analysis: In this prospective study, we are enrolling 200 English-speaking and/or Spanish-speaking patients with breast cancer or lymphoma seen at Mayo Clinic or Yale University who will receive intravenous cytotoxic chemotherapy. Physical function assessments will be obtained longitudinally using multiple assessment modalities. Participants will be followed for 9 months using a patient-centred health data aggregating platform that consolidates study questionnaires, electronic health record data, and activity and sleep data from a wearable sensor. Data analysis will focus on understanding variability, sensitivity and meaningful changes across the included physical function assessments and evaluating their relationship to key clinical outcomes. Additionally, the feasibility of multimodal physical function data collection in real-world patients with breast cancer or lymphoma will be assessed, as will patient impressions of the usability and acceptability of the wearable sensor, data aggregation platform and PROs., Ethics and Dissemination: This study has received approval from IRBs at Mayo Clinic, Yale University and the US Food and Drug Administration. Results will be made available to participants, funders, the research community and the public., Trial Registration Number: NCT05214144; Pre-results., Competing Interests: Competing interests: GT has received research funding from the from the Food and Drug Administration for the Yale-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI) (U01FD005938) that directly supports this work. She also receives grant funding from the US National Cancer Institute (NCI) U01 Tolerability Consortium (U01CA 2330463), and the Mayo Clinic Center for Clinical and Translational Research (CTSA) (KL2TR 023794). CG has received research funding from the NCCN Foundation (Astra-Zeneca) and Genentech, as well as funding from Johnson and Johnson to help devise and implement new approaches to sharing clinical trial data. Over the past three years, MMJ reports grant funding from the US Food and Drug Administration, National Institutes on Drug Abuse, Centers for Disease Control and Prevention, Agency for Healthcare Research and Quality, American Cancer Society, and the National Center for Advancing Translational Sciences. JSR currently receives research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing, from the Food and Drug Administration for the Yale-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI) (U01FD005938), from the Medical Devices Innovation Consortium as part of the National Evaluation System for Health Technology (NEST), from the Agency for Healthcare Research and Quality (R01HS022882), from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R01HS025164, R01HL144644), and from Arnold Ventures for the Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT); in addition, Ross is an expert witness at the request of Relator's attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen. JDR currently receives research support through Yale University from Johnson & Johnson to develop methods of clinical trial data sharing and from the US Food and Drug Administration for the Yale-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI) (U01FD005938). SH has received consulting fees outside of this work from Janssen, Genentech, AbbVie, Flatiron Health, BeiGene, AstraZeneca, ADC Therapeutics, Epizyme, Merck, Seattle Genetics, TG Therapeutics, Tyme, Pharmacyclics, SeaGen, and Arvinas. Over the past three years, KR reports grant funding from the US Food and Drug Administration, National Institutes of Health, United States Department of Defense, and American Cancer Society. SS has received consulting fees from Eisai, Celgene, SeaGen, and Cardinal Health. She has previously received research funding to her institution from Genetech and Pfizer. All other authors have no relevant conflicts of interest to disclose., (© Where applicable, author(s) (or their employer(s)) 2024. Re-use permitted under [CC BY]. Published by BMJ.)

Purpose: Intravenous immune globulin (IVIG) therapy is used in patients with hypogammaglobulinemia to lower the risk of infections. IVIG and subcutaneous IVIG (SCIG) therapy have been to shown to be safe and effective when administered as clinic-based infusions. Concern from both patients and providers for increased transmission of the coronavirus disease 2019 (COVID-19) virus to immunosuppressed patients with scheduled medical visits and procedures made it necessary for us to reassess our process of how we manage patient care in general and chronic clinic infusions in particular. Here we describe our experience of transitioning patients from clinic-based to home based IVIG and/or SCIG infusions to decrease the risk of COVID-19 exposure., Methods: Criteria were developed to identify high-risk immunosuppressed patients who would be appropriate candidates for potential conversion to home based IVIG infusions. Data were collected via chart review, and cost analysis was performed using Medicare Part B reimbursement data. A patient outcome questionnaire was developed for administration through follow-up phone calls., Results: From March to May 2020, 45 patients met criteria for home-based infusion, with 27 patients (60%) agreeing to home-based infusion. Posttransition patient outcomes assessment, conducted in 26 patients (96%), demonstrated good patient understanding of the home-based infusion process. No infusion-related complications were reported, and 24 patients (92%) had no concerns about receiving future IVIG and/or SCIG doses at home. No patient tested positive for COVID-19 during the study period. Clinic infusion visits decreased by 26.6 visits per month, resulting in a total of 106 hours of additional available infusion chair time per month and associated cost savings of $12,877., Conclusion: Transition of clinic based to home based IVIG/SCIG infusion can be successfully done to decrease potential exposure during a pandemic in a high-risk immunosuppressed population, with no impact on patient satisfaction, adherence, or efficacy. The home-based infusion initiative was associated with a reduction in costs to patients and an increase in available chair time in the infusion clinic., (© American Society of Health-System Pharmacists 2021. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

While health care costs can be considerable in individuals with diffuse large B-cell lymphoma (DLBCL), the degree to which health care expenditures vary following first-line treatment for non-relapsed versus relapsed DLBCL is unknown. Using 100% Medicare claims, we identified beneficiaries with DLBCL treated with first-line therapy between 1 January 2010 and 30 June 2014. We then compared health care expenditures of patients who received a second-line immunochemotherapy (relapse cohort) to those who did not begin a second-line therapy during follow-up (non-relapse cohort). After propensity score matching, the relapsed cohort incurred significantly higher health care costs ($6998 vs $3314 per month; p < .001), driven by inpatient ($2548 vs $1943 per month; p < .001) and outpatient office visit costs ($3581 vs $753 per month; p < .001). Our analysis confirms older adults with relapsed DLBCL incur higher medical costs and suggests improved first-line treatment would not only reduce the likelihood of relapse, but also contain health care costs.

Background: In recent years, serious adverse effects to children from exposure to single-use detergents sacs (SUDS) have been recognized. While most exposures result in minor symptoms, there have been serious outcomes. This study aims to classify which types of serious outcomes follow SUDS exposures, and to assess, if possible, differences in toxicity between various SUDS products., Methods: An observational case series with data collected retrospectively was performed for cases of SUDS exposures reported to a statewide poison system's records database from 1 January 2012 to 31 March 2013. Cases were identified and analyzed for clinical details and trends. A statewide database was queried for cases involving the American Association of Poison Control Centers (AAPCC) product-specific codes for SUDS products using following search terms: laundry pods, the AAPCC product-specific codes for Tide Pods, Purex Ultrapacks, ALL Mighty Pacs, and a unique agent code (AAPCC ID: 6903138; Generic: 077900) created by AAPCC to track SUDS exposures., Results: A total of 804 cases of exposures to SUDS were identified, the majority of which were exploratory ingestions in young children with a median age of 2 years. Serious adverse effects resulted from 65 (9%) exposures and 27 (3%) exposures resulted in admission to hospital. Binary logistic regression demonstrated that the presence of central nervous system (CNS) or respiratory system effects were associated with more severe outcomes, with a model accuracy of 96.4%. There were significant differences in morbidity among the three most common brand-name products: when compared with Tide Pods, odds ratios (OR) and 95% confidence intervals (CI) for severe outcome and admission rate were significantly greater following Purex Ultrapack exposures (severity OR 5.1 [CI: 2.13-12.23]; admission OR 10.36 [CI: 3.23-33.22]) and ALL Mighty Pac exposures (severity OR 11.22 [CI: 4.78-28.36]; admission OR 15.20 [CI: 5.01-46.12])., Conclusions: Serious complications from exposure to SUDS occur in a small number of exposures for unclear reasons. Respiratory and CNS effects are associated with more severe outcomes. Some brand-name products are associated with a relatively higher risk of severe adverse effects and rates of admission.

Purpose: Because leaders at medical schools and teaching hospitals need current data to estimate the clinical costs of graduate medical education, the authors developed a new methodology to estimate the hospital costs associated with the presence of teaching physicians for the year 2002., Method: A hospital accounting system was used to determine the case mix-adjusted direct variable costs for 41,522 inpatient admissions associated with or without a teaching physician., Results: Prior to adjustment, teaching cases had greater median costs than non-teaching cases. After severity adjustment, teaching cases in aggregate were associated with an additional 4.4% of the total direct variable cost of inpatient admissions, or US 3.6 million dollars. The size of the teaching effect varied by service, ranging from -5.7% for medical services to 13 percent for behavioral services. The effect of teaching on cost centers such as laboratory, pharmacy, and radiology varied by specialty service. Teaching was associated with a negligible 0.7% relative difference in length of stay., Conclusion: The incremental effects of teaching on hospital patient care costs are modest. These analyses can be repeated annually to detect changes in teaching costs and to target areas of excessive cost for interventions that improve efficiency. Our results and methods for identifying hospital costs associated with teaching services may prove useful in negotiations between academic health centers and affiliated teaching hospitals.

Managed care organizations should protect themselves from possible legal action by providers whom they have terminated, whether because of professional incompetence or for reasons related to the organization's business goals. Risk management begins by being aware of state and Federal laws regarding contracts, peer review, restraint of trade, discrimination, and retaliation against a provider. Managed care organizations should adopt a set of criteria for providers' professional competence as well as a list of business objectives that might necessitate the deselection of a provider. Because some courts have upheld a provider's right to a "fair procedure," managed care organizations also should consider offering providers an opportunity to respond to the termination decision.

The expansion of nurse advice lines by health plans has exposed them to a new area of liability. The author explores several recent cases in which health plans have been found accountable for actions of their nurse advice lines, and offers a series of suggestions for reducing health plan liability.

Managed care organizations can minimize their liability exposures by staying informed about industry changes and by implementing a comprehensive risk management program. Typically, managed care organizations face three general exposure areas: directors and officers liability (e.g., exposures associated with nonclinical aspects of an organization); errors and omissions (e.g., exposures involving the day-to-day operations of managing the health care received by an organization's members); and financial loss, or provider excess (e.g., exposures that occur when certain catastrophic events expose the organization to financial peril).

Home care and hospice providers participating in Medicare or Medicaid are subject to the new obligations created by the Patient Self-Determination Act, and therefore must be familiar with their states' laws on patients' rights to direct medical care.

The traditional, informal approach to making medical decisions for incapacitated patients is often inappropriate today. Guidelines are needed in two major areas: assessing incapacity and seeking surrogate decision makers. Judicially declared incompetency does not necessarily imply incapacity to make medical choices. Proposed standards for determining incapacity require a multistep evaluation of the patient's abilities to understand, reason, and communicate. When decisions must be made for an incapacitated patient, priority is given to the patient's previously stated preferences. An advance directive--living will or durable power of attorney--simplifies the process. If no advance directive was prepared, a surrogate decision maker may be designated according to applicable state statutes. Standards are still evolving for protecting the autonomy and best interests of vulnerable, incapacitated patients.

The growing elderly population and the acquired immunodeficiency syndrome (AIDS) epidemic have focused attention on ethical and legal issues surrounding health-care decision making. It is becoming increasingly critical to involve patients in the decisions that affect their care. Legal frameworks are evolving to protect the rights of both "competent" and "incompetent" patients. By writing instructions in advance, patients can increase their control and autonomy over health-care decisions. Physician assistants can facilitate the process by incorporating a patient value history into the chart and explaining legally recognized documents. Living wills generally apply in the context of terminal illness or irreversible coma; however, definitions of terminal conditions, imminent death, or life-sustaining procedures can be problematic. A number of states recognize the health-care durable power of attorney, which establishes a surrogate decision maker to act with specific instructions and limitations should the patient become incompetent or incapacitated.