Practice efficiency and total cost of care with bispecifics and CAR-T in relapsed/refractory diffuse large B-cell lymphoma: an institutional perspective.

Aim: Novel treatment options for relapsed/refractory diffuse large B-cell lymphoma include T-cell targeting therapies. Practice efficiency and cost are important for informed treatment decisions.Materials/methods: An institutional decision-maker cost model was developed for 6-month, 1-year and median cycles of treatment time horizons comparing practice efficiency and costs of epcoritamab vs glofitamab and axicabtagene ciloleucel (axi-cel).Results: Overall, epcoritamab required the shortest personnel and chair time, except over 1 year (second shortest chair time). Across all time horizons, epcoritamab was cost-saving vs axi-cel and had similar costs to glofitamab on a per-month basis.Conclusion: Epcoritamab reduced personnel and chair time. Additionally, epcoritamab was cost-saving vs axi-cel and had similar costs to glofitamab on a per-month basis.

There are new ways to treat diffuse large B-cell lymphoma, which is a type of cancer called lymphoma. When new treatments are available it is important to see if they take more or less time to give to patients and how much they cost versus other treatments. This study looked at three drugs used to treat diffuse large B-cell lymphoma, including epcoritamab, axi-cel and glofitamab. It estimated the time and cost with those treatments in patients who get them for 6 months, 1 year or for the most common length of time in the clinical trials. In most of the scenarios, epcoritamab had the least time needed for nurses or doctors and the least time needed for a patient to be in a chair in a clinic. When thinking about the cost per month, epcoritamab saved money versus axi-cel and was similar to glofitamab.

Beneficial Effects of Early Intervention Telemedicine-based Follow-Up in Sleep Apnea: A Randomized Controlled Multicenter Trial.

Rationale: Positive airway pressure (PAP) is standard treatment for obstructive sleep apnea. Telemedicine has been introduced for improved PAP follow-up. Objectives: Our study aim was to evaluate the clinical utility of and patient satisfaction with PAP follow-up with an early intervention telemedical protocol. Methods: A randomized controlled trial was conducted at four sleep clinics of the same county. Treatment-naive patients with obstructive sleep apnea were randomized to standard PAP follow-up (203 patients, fixed follow-up procedures) or early intervention telemedical follow-up (AirView, ResMed; 206 patients, continuous follow-up) for 3 months. Evaluated variables included PAP adherence at 3 months, patient-reported outcome measures (Epworth Sleepiness Scale, 36-item Short Form Health Survey, Insomnia Severity Index, Hospital Anxiety and Depression Scale), and staff time. Group differences were analyzed with linear mixed regression models adjusted for age, body mass index, apnea-hypopnea index, and study center. Results: The study groups were comparable at baseline (N = 409; mean age, 59 ± 12 yr; body mass index, 31.9 ± 6 kg/m2, apnea-hypopnea index, 41.5 ± 21 events/h). PAP adherence was higher in the proactive telemedicine group than in the control group (4.3 ± 2.4 and 4.1 ± 2.6 h/night; P = 0.01, respectively), and mean mask pressure at follow-up was significantly lower in the telemedicine group than in the control group (8.7 ± 2.1 cm H2O vs. 9.2 ± 2.5 cm H2O; P = 0.028). In post hoc analysis, the difference in PAP adherence between groups was most pronounced in patients with depression (4.8 ± 2.6 h/night vs. 2.7 ± 2.3 h/night; P = 0.03). Relevant mask leakage (>24 L/min) was lower in the telemedicine group (5.4% vs. 12.1%, P = 0.024). Improvement of patient-reported outcome measures and patient satisfaction was equivalent between groups. Conclusions: Proactive telemedical management of the initial follow-up of PAP treatment compared favorably with conventional follow-up in terms of adherence, pressure level, and mask leakage. Patients with depression may particularly benefit from telemedical follow-up. Specific clinical routines are required to establish this practice in sleep clinics. Clinical trial registered with www.clinicaltrials.gov (NCT03446560).

The Need for an Economically Feasible Nursing Home Staffing Regulation: Evaluating an Acuity-Based Nursing Staff Benchmark.

Background and Objectives: Despite concerns about the adequacy of nursing home (NH) staffing, the federal agency responsible for NH certification and regulation has never adopted an explicit quantitative nursing staff standard. A prior study has proposed a benchmark for this purpose based on the 1995/97 Staff Time Measurement (STM) studies. This article aims to assess the extent to which NHs staff to this proposed STM benchmark, the extent to which regulators already implicitly apply the STM benchmark, and compute the additional operating expenses NHs would incur to adhere to the STM benchmark. Research Design and Methods: Using NH Compare Archive data, the STM benchmark was compared to staffing levels reported by the facility and whether NHs received a nursing staff deficiency. Using financial information from Medicare Cost Reports, the additional annual operating expenses required to staff to the STM benchmark were calculated for each state and nationwide. Results: The vast majority of NHs did not staff to the STM benchmark; 80.2% for registered nurses and 60.0% for total nursing staff. Deficiency patterns showed that NH regulators were not using the STM benchmark to determine sufficiency of nursing staff. Implementing the STM benchmark as a regulatory standard would increase operating expenses for 59.1% of NHs, at an average annual cost of half-million dollars per facility. The nationwide increase in operating expense is estimated to be at least $4.9 billion per year. Discussion and Implications: Without clear guidance on the staffing level needed to be sufficiently staffed, most NHs are subject to a community standard of care, which some have argued could be associated with suboptimal staffing levels. Implementing an acuity-based benchmark could result in improved staffing levels but also comes with significant economic costs. The STM benchmark is not economically feasible at current Medicare and Medicaid reimbursement levels.

Pragmatic considerations and approaches for measuring staff time as an implementation cost in health systems and clinics: key issues and applied examples.

BACKGROUND: As the field of implementation science wrestles with the need for system decision-makers to anticipate the budget impact of implementing new programs, there has been a push to report implementation costs more transparently. For this purpose, the method of time-driven activity-based costing (TDABC) has been heralded as a pragmatic advance. However, a recent TDABC review found that conventional methods for estimating staff time remain resource-intensive and called for simpler alternatives. Our objective was to conceptually compare conventional and emerging TDABC approaches to measuring staff time. METHODS: Our environmental scan of TDABC methods identified several categories of approaches for staff time estimation; across these categories, staff time was converted to cost as a pro-rated fraction of salary/benefits. Conventional approaches used a process map to identify each step of program delivery and estimated the staff time used at each step in one of 3 ways: (a) uniform estimates of time needed for commonly occurring tasks (self-report), (b) retrospective "time diary" (self-report), or (c) periodic direct observation. In contrast, novel semi-automated electronic health record (EHR) approaches "nudge" staff to self-report time for specific process map step(s)-serving as a contemporaneous time diary. Also, novel EHR-based automated approaches include timestamps to track specific steps in a process map. We compared the utility of these TDABC approach categories according to the 5 R's model that measures domains of interest to system decision-makers: relevance, rapidity, rigor, resources, and replicability, and include two illustrative case examples. RESULTS: The 3 conventional TDABC staff time estimation methods are highly relevant to settings but have limited rapidity, variable rigor, are rather resource-intensive, and have varying replicability. In contrast to conventional TDABC methods, the semi-automated and automated EHR-based approaches have high rapidity, similar rigor, similar replicability, and are less resource-intensive, but have varying relevance to settings. CONCLUSIONS: This synthesis and evaluation of conventional and emerging methods for staff time estimation by TDABC provides the field of implementation science with options beyond the current approaches. The field remains pressed to innovatively and pragmatically measure costs of program delivery that rate favorably across all of the 5 R's domains.

Participant recruitment into a community-based diabetes prevention trial in India: Learnings from the Kerala Diabetes Prevention Program.

BACKGROUND: Data on participant recruitment into diabetes prevention trials are limited in low- and middle-income countries (LMICs). We aimed to provide a detailed analysis of participant recruitment into a community-based diabetes prevention trial in India. METHODS: The Kerala Diabetes Prevention Program was conducted in 60 polling areas (electoral divisions) of the Neyyatinkara taluk (subdistrict) in Trivandrum district, Kerala state. Individuals (age 30-60 years) were screened with the Indian Diabetes Risk Score (IDRS) at their homes followed by an oral glucose tolerance test (OGTT) at community-based clinics. Individuals at high-risk of developing diabetes (IDRS score ≥60 and without diabetes on the OGTT) were recruited. RESULTS: A total of 1007 participants (47.2% women) were recruited over nine months. Pilot testing, personal contact and telephone reminders from community volunteers, and gender matching of staff were effective recruitment strategies. The major recruitment challenges were: (1) during home visits, one-third of potential participants could not be contacted, as they were away for work; and (2) men participated less frequently in the OGTT screening than women (75.2% vs. 84.2%). For non-participation, lack of time (42.0%) was most commonly cited followed by 'I am already feeling healthy' (30.0%), personal reasons (24.0%) and 'no benefit to me or my family' (4.0%). An average of 17 h were spent to recruit one participant with a cost of US$23. The initial stage of screening and recruitment demanded higher time and costs. CONCLUSIONS: This study provides valuable information for future researchers planning to implement community-based diabetes prevention trials in India or other LMICs. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry: ACTRN12611000262909.