Objectives The purpose of this study was to provide normative data on fall prevalence in US hospitals by unit type and to determine the 27-month secular trend in falls prior to the implementation of the Centers for Medicare and Medicaid Service (CMS) rule which does not reimburse hospitals for care related to injury resulting from hospital falls. Methods We used data from the National Database of Nursing Quality Indicators (NDNQI) collected between July 1, 2006 and September 30, 2008 to estimate prevalence and secular trends of falls occurring in adult medical, medical-surgical and surgical nursing units. More than 88 million patient days (pd) of observation were contributed from 6,100 medical, surgical, and medical-surgical nursing units in 1,263 hospitals across the United States. Results A total of 315,817 falls occurred (rate=3.56 falls/1,000 pd) during the study period, of which 82,332 (26.1%) resulted in an injury (rate=0.93/1,000 pd). Both total fall and injurious fall rates were highest in medical units (fall rate=4.03/1,000 pd; injurious fall rate=1.08/1,000 pd) and lowest in surgery units (fall rate=2.76/1,000 pd; injurious fall rate=0.67/1,000 pd). Falls (0.4% decrease/quarter, p<0.0001) and injurious falls (1% decrease per quarter, p<0.0001) both decreased over the 27-month study. Conclusions In this large sample, fall and injurious fall prevalence varied by nursing unit type in US hospitals. Over the 27 month study, there was a small, but statistically significant, decrease in falls (p<0.0001) and injurious falls (p<0.0001).

Background Bed alarm systems intended to prevent hospital falls have not been formally evaluated. Objective To investigate whether an intervention aimed at increasing bed alarm use decreases hospital falls and related events. Design Pair-matched, cluster randomized trial over 18 months. Nursing units were allocated by computer-generated randomization on the basis of baseline fall rates. Patients and outcome assessors were blinded to unit assignment; outcome assessors may have become unblinded. (ClinicalTrials.gov registration number: NCT00183053) Setting 16 nursing units in an urban community hospital. Patients 27 672 inpatients in general medical, surgical, and specialty units. Intervention Education, training, and technical support to promote use of a standard bed alarm system (intervention units); bed alarms available but not formally promoted or supported (control units). Measurements Pre–post difference in change in falls per 1000 patient-days (primary end point); number of patients who fell, fall-related injuries, and number of patients restrained (secondary end points). Results Prevalence of alarm use was 64.41 days per 1000 patient-days on intervention units and 1.79 days per 1000 patient-days on control units (P = 0.004). There was no difference in change in fall rates per 1000 patient-days (risk ratio, 1.09 [95% CI, 0.85 to 1.53]; difference, 0.41 [CI, −1.05 to 2.47], which corresponds to a greater difference in falls in control vs. intervention units) or in the number of patients who fell, injurious fall rates, or the number of patients physically restrained on intervention units compared with control units. Limitation The study was conducted at a single site and was slightly underpowered compared with the initial design. Conclusion An intervention designed to increase bed alarm use in an urban hospital increased alarm use but had no statistically or clinically significant effect on fall-related events or physical restraint use. Primary Funding Source National Institute on Aging.

Pancreatic ductal adenocarcinoma (PDAC) is lethal in 88% of patients1, yet harbours mutation-derived T cell neoantigens that are suitable for vaccines 2,3. Here in a phase I trial of adjuvant autogene cevumeran, an individualized neoantigen vaccine based on uridine mRNA–lipoplex nanoparticles, we synthesized mRNA neoantigen vaccines in real time from surgically resected PDAC tumours. After surgery, we sequentially administered atezolizumab (an anti-PD-L1 immunotherapy), autogene cevumeran (a maximum of 20 neoantigens per patient) and a modified version of a four-drug chemotherapy regimen (mFOLFIRINOX, comprising folinic acid, fluorouracil, irinotecan and oxaliplatin). The end points included vaccine-induced neoantigen-specific T cells by high-threshold assays, 18-month recurrence-free survival and oncologic feasibility. We treated 16 patients with atezolizumab and autogene cevumeran, then 15 patients with mFOLFIRINOX. Autogene cevumeran was administered within 3 days of benchmarked times, was tolerable and induced de novo high-magnitude neoantigen-specific T cells in 8 out of 16 patients, with half targeting more than one vaccine neoantigen. Using a new mathematical strategy to track T cell clones (CloneTrack) and functional assays, we found that vaccine-expanded T cells comprised up to 10% of all blood T cells, re-expanded with a vaccine booster and included long-lived polyfunctional neoantigen-specific effector CD8+ T cells. At 18-month median follow-up, patients with vaccine-expanded T cells (responders) had a longer median recurrence-free survival (not reached) compared with patients without vaccine-expanded T cells (non-responders; 13.4 months, P = 0.003). Differences in the immune fitness of the patients did not confound this correlation, as responders and non-responders mounted equivalent immunity to a concurrent unrelated mRNA vaccine against SARS-CoV-2. Thus, adjuvant atezolizumab, autogene cevumeran and mFOLFIRINOX induces substantial T cell activity that may correlate with delayed PDAC recurrence.

IMPORTANCEIn 2008, Medicare implemented the Hospital-Acquired Conditions (HACs) Initiative, a policy denying incremental payment for 8 complications of hospital care, also known as never events. The regulation's effect on these events has not been well studied.OBJECTIVE To measure the association between Medicare's nonpayment policy and 4 outcomes addressed by the HACs Initiative: central line-associated bloodstream infections (CLABSIs), catheter-associated urinary tract infections (CAUTIs), hospital-acquired pressure ulcers (HAPUs), and injurious inpatient falls. DESIGN, SETTING, AND PARTICIPANTSQuasi-experimental study of adult nursing units from 1381 US hospitals participating in the National Database of Nursing Quality Indicators (NDNQI), a program of the American Nurses Association. The NDNQI data were combined with American Hospital Association, Medicare Cost Report, and local market data to examine adjusted outcomes. Multilevel models were used to evaluate the effect of Medicare's nonpayment policy on never events.EXPOSURES United States hospitals providing treatment for Medicare patients were subject to the new payment policy beginning in October 2008. MAIN OUTCOMES AND MEASURESChanges in unit-level rates of HAPUs, injurious falls, CLABSIs, and CAUTIs after initiation of the policy. RESULTS Medicare's nonpayment policy was associated with an 11% reduction in the rate of change in CLABSIs (incidence rate ratio [IRR], 0.89; 95% CI, 0.83-0.95) and a 10% reduction in the rate of change in CAUTIs (IRR, 0.90; 95% CI, 0.85-0.95), but was not associated with a significant change in injurious falls (IRR, 0.99; 95% CI, 0.99-1.00) or HAPUs (odds ratio, 0.98; 95% CI, 0.96-1.01). Consideration of unit-, hospital-, and market-level factors did not significantly alter our findings. CONCLUSIONS AND RELEVANCEThe HACs Initiative was associated with improvements in CLABSI and CAUTI trends, conditions for which there is strong evidence that better hospital processes yield better outcomes. However, the HACs Initiative was not associated with improvements in HAPU or injurious fall trends, conditions for which there is less evidence that changing hospital processes leads to significantly better outcomes.

Background Patient falls are among the most commonly reported adverse hospital events with more than one million occurring annually in the United States; approximately 10% result in serious injury. A retrospective study was conducted to determine predictors and outcomes of fall injuries among a cohort of adult hospitalized patients. Methods Data were obtained regarding patients who sustained an initial fall in hospital during a 26-month period from 16 adult general medical and surgical units in an urban university-affiliated community hospital. Data on intrinsic (individual) factors, extrinsic (environmental) factors, and situational activities were collected via nurse and patient interviews, patient examinations, and audits of incident reports and electronic health records. Fall injuries were classified as none/any for analyses. Unadjusted odds ratios [ORs] and 95% confidence intervals [CIs] for each of the variables of interest with fall injury were generated using logistic regressions. Results The 784 patients had a median age of 63.5 years (range, 20 to > 90 years), 390 (50%) were women, and 526 (67%) were black. Some 228 (29%) fallers sustained injury; patients who were white (OR: 2.23; 95% CI: 1.62, 3.08), or were administered a selective serotonin reuptake inhibitor (OR: 1.04; 95% CI: 1.04, 2.67), two antipsychotic agents (OR: 3.26; 95% CI: 1.20, 8.90), an opiate (OR: 1.59; 95%; CI: 1.14, 2.20), or a diuretic non-antihypertensive agent (OR: 1.53; 95% CI: 1.03, 2.26) were more likely to sustain an injury. Home-based wheelchair use was protective of fall injury (OR: 0.20; 95% CI: 0.05, 0.84). Seventy-nine percent of the patients had been designated as “high” fall risk within 24 hours before the fall. Conclusions Few variables were able to distinguish patients who sustained injury after a hospital fall, further challenging clinicians’ efforts to minimize hospital-related fall injury.