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Lean is one of the most widely used improvement approaches in healthcare. With origins in manufacturing, it focuses on improving efficiency, eliminating waste, and streamlining processes. This Element provides an overview of the evidence for the use of Lean in healthcare, summarises the supporting tools and techniques, and emphasises the importance of developing an organisational culture committed to continuous improvement. The authors offer two case studies of attempts to implement Lean at scale, noting that, despite its popularity, implementation is not straightforward. Challenges include terminology that isn't always easy to grasp, perceived dissonances between the manufacturing origins of Lean based on repetitive, standardised, automated production and the human-centred world of healthcare, and problems with fidelity. The authors make the case that there is a lack of a robust evidence base for Lean and call for well-designed studies to advance the implementation of Lean and associated process improvement techniques in healthcare. This title is also available as open access on Cambridge Core.
There is a growing focus on understanding the complexity of dietary patterns and how they relate to health and other factors. Approaches that have not traditionally been applied to characterise dietary patterns, such as latent class analysis and machine learning algorithms, may offer opportunities to characterise dietary patterns in greater depth than previously considered. However, there has not been a formal examination of how this wide range of approaches has been applied to characterise dietary patterns. This scoping review synthesised literature from 2005 to 2022 applying methods not traditionally used to characterise dietary patterns, referred to as novel methods. MEDLINE, CINAHL and Scopus were searched using keywords including latent class analysis, machine learning and least absolute shrinkage and selection operator. Of 5274 records identified, 24 met the inclusion criteria. Twelve of twenty-four articles were published since 2020. Studies were conducted across seventeen countries. Nine studies used approaches with applications in machine learning, such as classification models, neural networks and probabilistic graphical models, to identify dietary patterns. The remaining studies applied methods such as latent class analysis, mutual information and treelet transform. Fourteen studies assessed associations between dietary patterns characterised using novel methods and health outcomes, including cancer, cardiovascular disease and asthma. There was wide variation in the methods applied to characterise dietary patterns and in how these methods were described. The extension of reporting guidelines and quality appraisal tools relevant to nutrition research to consider specific features of novel methods may facilitate consistent reporting and enable synthesis to inform policies and programs.
Creating a well-integrated, resilient, and highly transparent supply chain is central to effective and safe patient care. But managing healthcare supply chains is complex; common challenges include the underuse, overuse, and misuse of health resources. This Element introduces the key principles and definitions of healthcare supply chains. Practical insights into the design and operation of healthcare supply chains are provided. Core characteristics of effective supply chain management such as performance management, systems thinking, and supply chain integration are examined along with the application of specific supply chain design and improvement approaches. Finally, the Element proposes areas that require further development both in research and practice. This title is also available as open access on Cambridge Core.
– is essential for determining neurocognitive status, and functional assessment is often provided via informant report. While informant characteristics have been shown to influence reports of participant functioning, the degree to which they moderate relationships between reported functioning and participant performance on neuropsychological testing is unclear. Moreover, associations among informant characteristics, reported functioning, and neuropsychological performance have not been directly examined with non-Hispanic Black (NHB) samples, despite this population’s disproportionately high risk for dementia.
Participants and Methods:
In this cross-sectional observational study, we examined the influence of informant characteristics on (1) informant reports of participant functioning (assessed via the Functional Activity Questionnaire [FAQ]), and (2) associations between reported functioning and participant performance on neuropsychological testing, among NHB adult participants in the National Alzheimer’s Coordinating Center cohort (n=1024).
Results:
Younger age, female sex/gender, higher education, longer relationships with participants, and cohabitation were informant characteristics associated with poorer reported functioning (ps<.01). Moreover, poorer reported functioning was associated with poorer performance on (1) memory and language tests, particularly for participants with male (versus female) informants, and (2) the Multilingual Naming Test, particularly for participants with cohabitating (versus non-cohabitating) informants (ps<.01).
Conclusions:
Within the context of neurocognitive evaluation of NHB adults, informant age, sex/gender, education, relationship length, and cohabitation status influence informant reports of participant functioning, and informant sex/gender and cohabitation status in turn moderate associations between reported functioning and participant performance on comprehensive neuropsychological testing.
After experiencing disappointment due to numerous patients not turning up to their memory assessment service (MAS) appointments as well as the effect of losing man-hours due to this we decided to investigate how best to improve the attendance rates of our MAS patients. The initial frustration occurred when several patients for multiple team members were not attending their appointments. When followed up they stated that they had not received the required letters or follow up telephone calls prompting them to attend their appointments. This led to the initial hypotheses that a formal structure was required in part to aid in the delivery of this service and improve attendance.
Methods
We initially investigated the percentage of patient's that did not attend their appointments from the period of August 2022 to December 2022. This was achieved utilising the trust's data collection team. From these initial raw data we processed and calculated the delay between appointment allocation and a letter being sent out as well as basic percentages of patients not attending each month. What we realised was that there was no strict average and our admin team were not aware of any pathway that they could utilise as a guideline for the management of patient appointments. We therefore outlined the overall process of the appointment pathway and formed this. Upon this foundation we subsequently ironed out the optimal points of contact between our admin team and patients and when this could be accomplished and documented. The aims of these points of contact overall was to improve the rates of patients not attending their appointments and improving our target of appointment attendance. We subsequently re-evaluated our patient attendance five months after the formation of the posters, which were affixed in the admin and memory nurse rooms at our base.
Results
The results overall were quite promising and did appear to show a change based upon the formalisation of the MAS appointment pathway.
Conclusion
The results showed a positive improvement to the attendance rate of the MAS patients and also demonstrated the empowerment that a team can have when a formal pathway is in place. This fully completed audit cycle demonstrated the importance of such a pathway and how to address what is often a multi-faceted problem for many community based services. Our conclusion appears to support our hypotheses that a formal pathway can often improve the provision of a service.
Despite promising steps towards the elimination of hepatitis C virus (HCV) in the UK, several indicators provide a cause for concern for future disease burden. We aimed to improve understanding of geographical variation in HCV-related severe liver disease and historic risk factor prevalence among clinic attendees in England and Scotland. We used metadata from 3829 HCV-positive patients consecutively enrolled into HCV Research UK from 48 hospital centres in England and Scotland during 2012–2014. Employing mixed-effects statistical modelling, several independent risk factors were identified: age 46–59 y (ORadj 3.06) and ≥60 y (ORadj 5.64) relative to <46 y, male relative to female sex (ORadj 1.58), high BMI (ORadj 1.73) and obesity (ORadj 2.81) relative to normal BMI, diabetes relative to no diabetes (ORadj 2.75), infection with HCV genotype (GT)-3 relative to GT-1 (ORadj 1.75), route of infection through blood products relative to injecting drug use (ORadj 1.40), and lower odds were associated with black ethnicity (ORadj 0.31) relative to white ethnicity. A small proportion of unexplained variation was attributed to differences between hospital centres and local health authorities. Our study provides a baseline measure of historic risk factor prevalence and potential geographical variation in healthcare provision, to support ongoing monitoring of HCV-related disease burden and the design of risk prevention measures.
This chapter explores concepts of service delivery including coverage, provision of health care, processes and inputs involved in delivery of services, and the requirements for good quality care in low and middle-income countries (L&MICs). Health service delivery models are organized in diverse ways that encompass the levels of care, location and platforms, as well as vertical and horizontal modes of integration, and personal and non-personal services. Several key characteristics and enablers are markers of high-quality health services and when adhered to lead to favourable health outcomes. The community’s preferences and demand with regard to what services to provide is key to building their trust. Essential packages for defining health services should be needs-based, incorporating the disease burden, ensuring quality, coverage and utilization needed to have good health outcomes. The pursuit of Universal Health Coverage requires Primary Health Care as the foundation of health systems in L&MICs, equity in services provision, as well as good information and monitoring systems.
We compared the effectiveness of 4 sampling methods to recover Staphylococcus aureus, Klebsiella pneumoniae and Clostridioides difficile from contaminated environmental surfaces: cotton swabs, RODAC culture plates, sponge sticks with manual agitation, and sponge sticks with a stomacher. Organism type was the most important factor in bacterial recovery.
In March 2018, the US Food and Drug Administration (FDA), US Centers for Disease Control and Prevention, California Department of Public Health, Los Angeles County Department of Public Health and Pennsylvania Department of Health initiated an investigation of an outbreak of Burkholderia cepacia complex (Bcc) infections. Sixty infections were identified in California, New Jersey, Pennsylvania, Maine, Nevada and Ohio. The infections were linked to a no-rinse cleansing foam product (NRCFP), produced by Manufacturer A, used for skin care of patients in healthcare settings. FDA inspected Manufacturer A's production facility (manufacturing site of over-the-counter drugs and cosmetics), reviewed production records and collected product and environmental samples for analysis. FDA's inspection found poor manufacturing practices. Analysis by pulsed-field gel electrophoresis confirmed a match between NRCFP samples and clinical isolates. Manufacturer A conducted extensive recalls, FDA issued a warning letter citing the manufacturer's inadequate manufacturing practices, and federal, state and local partners issued public communications to advise patients, pharmacies, other healthcare providers and healthcare facilities to stop using the recalled NRCFP. This investigation highlighted the importance of following appropriate manufacturing practices to minimize microbial contamination of cosmetic products, especially if intended for use in healthcare settings.
We quantified hospital-acquired coronavirus disease 2019 (COVID-19) during the early phases of the pandemic, and we evaluated solely temporal determinations of hospital acquisition.
Design:
Retrospective observational study during early phases of the COVID-19 pandemic, March 1–November 30, 2020. We identified laboratory-detected severe acute respiratory coronavirus virus 2 (SARS-CoV-2) from 30 days before admission through discharge. All cases detected after hospital day 5 were categorized by chart review as community or unlikely hospital-acquired cases, or possible or probable hospital-acquired cases.
Setting:
The study was conducted in 2 acute-care hospitals in Chicago, Illinois.
Patients:
The study included all hospitalized patients including an inpatient rehabilitation unit.
Interventions:
Each hospital implemented infection-control precautions soon after identifying COVID-19 cases, including patient and staff cohort protocols, universal masking, and restricted visitation policies.
Results:
Among 2,667 patients with SARS-CoV-2, detection before hospital day 6 was most common (n = 2,612; 98%); detection during hospital days 6–14 was uncommon (n = 43; 1.6%); and detection after hospital day 14 was rare (n = 16; 0.6%). By chart review, most cases after day 5 were categorized as community acquired, usually because SARS-CoV-2 had been detected at a prior healthcare facility (68% of cases on days 6–14 and 53% of cases after day 14). The incidence rates of possible and probable hospital-acquired cases per 10,000 patient days were similar for ICU- and non-ICU patients at hospital A (1.2 vs 1.3 difference, 0.1; 95% CI, −2.8 to 3.0) and hospital B (2.8 vs 1.2 difference, 1.6; 95% CI, −0.1 to 4.0).
Conclusions:
Most patients were protected by early and sustained application of infection-control precautions modified to reduce SARS-CoV-2 transmission. Using solely temporal criteria to discriminate hospital versus community acquisition would have misclassified many “late onset” SARS-CoV-2–positive cases.
ABSTRACT IMPACT: Our implementation model translates two evidence-based nutritional and behavioral interventions to lower blood pressure, into a community-based intervention program for seniors receiving congregate meals. OBJECTIVES/GOALS: The Rockefeller University, Clinical Directors Network, and Carter Burden Network received an Administration for Community Living Nutrition Innovation grant to test whether implementation of DASH-concordant meals and health education programs together lower blood pressure among seniors aging in place. METHODS/STUDY POPULATION: n=200, >60 yr, >4 meals/week at CBN; engagement of seniors/stakeholders in planning and conduct; Advisory Committee to facilitate dissemination; menus aligned with Dietary Approaches to Stop Hypertension (DASH) and NYC Department for the Aging nutritional guidelines; interactive sessions for education in nutrition, BP management, medication adherence. Training in use of automated daily home BP monitors (Omron 20). Validated surveys at M0, M1, M3, M6. Taste preference and cost assessed through Meal Satisfaction (Likert scale) and Plate Waste measures. Primary Outcome: Change in Systolic BP (SBP) at Month 1; change in %BP controlled. Secondary: validated cognitive, behavioral, nutritional measures (SF-12, PQH-2), economics; staff/client satisfaction, trends and significant associations. RESULTS/ANTICIPATED RESULTS: n=94, x2 age =73 +/- 8 years, 65% female, 50% White, 32% Black/African American, 4% Asian, 1% American Indian, Alaskan Native, 13% Other, 32% Latino/a, 43% with income <$20,000. Mean SBP at Baseline was 137.87 +18.8 mmHg (range 98-191). Menus were adapted to provide 20% daily DASH requirements at breakfast, 50% at lunch. Participants attended classes in nutrition and medication management and were provided with and trained to use an automated home BP monitor. Meal satisfaction scores dipped briefly then met or exceed pre-DASH levels. Home BP data was downloaded every 2-4 weeks with social/behavioral support. The COVID-19 closures interfered with BP outcome data collection and meal service ceased. Primary outcome: x2 change in SBP at Month 1 = -4.41 mmHg + 18 (n=61) (p=0.713). Significant associations will be reported. DISCUSSION/SIGNIFICANCE OF FINDINGS: Our community-academic research partnership implemented the DASH diet in congregate-meal settings to address uncontrolled hypertension in seniors. COVID-19 interrupted the study, but encouraging trends were observed that may inform refinement to this community-based health intervention for seniors.
Background: Carbapenem-resistant Enterobacteriaceae (CRE) are endemic in the Chicago region. We assessed the regional impact of a CRE control intervention targeting high-prevalence facilities; that is, long-term acute-care hospitals (LTACHs) and ventilator-capable skilled nursing facilities (vSNFs). Methods: In July 2017, an academic–public health partnership launched a regional CRE prevention bundle: (1) identifying patient CRE status by querying Illinois’ XDRO registry and periodic point-prevalence surveys reported to public health, (2) cohorting or private rooms with contact precautions for CRE patients, (3) combining hand hygiene adherence, monitoring with general infection control education, and guidance by project coordinators and public health, and (4) daily chlorhexidine gluconate (CHG) bathing. Informed by epidemiology and modeling, we targeted LTACHs and vSNFs in a 13-mile radius from the coordinating center. Illinois mandates CRE reporting to the XDRO registry, which can also be manually queried or generate automated alerts to facilitate interfacility communication. The regional intervention promoted increased automation of alerts to hospitals. The prespecified primary outcome was incident clinical CRE culture reported to the XDRO registry in Cook County by month, analyzed by segmented regression modeling. A secondary outcome was colonization prevalence measured by serial point-prevalence surveys for carbapenemase-producing organism colonization in LTACHs and vSNFs. Results: All eligible LTACHs (n = 6) and vSNFs (n = 9) participated in the intervention. One vSNF declined CHG bathing. vSNFs that implemented CHG bathing typically bathed residents 2–3 times per week instead of daily. Overall, there were significant gaps in infection control practices, especially in vSNFs. Also, 75 Illinois hospitals adopted automated alerts (56 during the intervention period). Mean CRE incidence in Cook County decreased from 59.0 cases per month during baseline to 40.6 cases per month during intervention (P < .001). In a segmented regression model, there was an average reduction of 10.56 cases per month during the 24-month intervention period (P = .02) (Fig. 1), and an estimated 253 incident CRE cases were averted. Mean CRE incidence also decreased among the stratum of vSNF/LTACH intervention facilities (P = .03). However, evidence of ongoing CRE transmission, particularly in vSNFs, persisted, and CRE colonization prevalence remained high at intervention facilities (Table 1). Conclusions: A resource-intensive public health regional CRE intervention was implemented that included enhanced interfacility communication and targeted infection prevention. There was a significant decline in incident CRE clinical cases in Cook County, despite high persistent CRE colonization prevalence in intervention facilities. vSNFs, where understaffing or underresourcing were common and lengths of stay range from months to years, had a major prevalence challenge, underscoring the need for aggressive infection control improvements in these facilities.
Funding: The Centers for Disease Control and Prevention (SHEPheRD Contract No. 200-2011-42037)
Disclosures: M.Y.L. has received research support in the form of contributed product from OpGen and Sage Products (now part of Stryker Corporation), and has received an investigator-initiated grant from CareFusion Foundation (now part of BD).
Lumateperone (lumateperone tosylate, ITI-007) is an investigational drug for the treatment of schizophrenia, bipolar depression, and other disorders. Lumateperone has a unique mechanism of action that simultaneously modulates serotonin, dopamine, and glutamate neurotransmission. This may provide advantages in the treatment of the broad symptoms associated with schizophrenia, including negative and depression symptoms. In 2 previous placebo-controlled trials in patients with acute schizophrenia, lumateperone 42mg (ITI-007 60mg) demonstrated statistically significant improvement in the Positive and Negative Syndrome Scale (PANSS) Total score compared with placebo. In these studies, lumateperone was well tolerated with a safety profile similar to placebo. This open-label long-term study evaluated the safety and effectiveness of lumateperone 42mg in patients with schizophrenia and stable symptoms.
Methods:
Patients with stable schizophrenia were treated for up to 1 year with lumateperone 42mg. Safety assessments included adverse events (AEs), body weight, laboratory parameters, and extrapyramidal symptoms (EPS)/motor symptom assessments. Efficacy analyses included evaluation of changes in PANSS Total score and in depression symptoms, as measured by the Calgary Depression Scale for Schizophrenia (CDSS).
Results:
In the 1-year open-label study, 602 patients received at least 1 dose of lumateperone 42mg; at the time of this interim analysis, 107 patients had completed 1 year of treatment. Only 4 TEAEs occurred in ≥5% of patients (weight decrease, dry mouth, headache and diarrhea); the majority of AEs were mild or moderate in intensity. Most metabolic parameters and mean prolactin levels decreased from SOC baseline, as did mean body weight and BMI. Based on AE reporting and EPS/motor symptom scales, lumateperone treatment was associated with minimal EPS risk. Lumateperone 42mg treatment was associated with significant reductions in PANSS Total score from baseline, with continuing PANSS improvement throughout the study. In patients with moderate-to-severe depression symptoms at baseline (CDSS>5), mean CDSS scores decreased from 7.4 (baseline) to 3.1 (Day 300); 60% of patients met CDSS response criteria (50% improvement from baseline) by Day 75 and this response rate was maintained through day 300. Similar magnitude of CDSS improvement was seen regardless of concurrent antidepressant therapy.
Conclusion:
In long-term treatment, lumateperone was associated with minimal metabolic, EPS, and cardiovascular safety issues relative to current SOC antipsychotic therapy. Lumateperone improved schizophrenia symptoms with continued long-term treatment. In patients with moderate-to-severe depression symptoms at baseline, lumateperone treatment was associated with marked improvement in CDSS scores. These data are consistent with and extend data previously reported in placebo-controlled studies in patients with acute schizophrenia treated with lumateperone.
Funding Acknowledgements:
Supported by funding from Intra-Cellular Therapies, Inc.
Lumateperone (ITI-007) is in late-phase clinical development for schizophrenia. Lumateperone has a unique mechanism of action that modulates serotonin, dopamine, and glutamate neurotransmission. This pooled analysis of lumateperone in 3 randomized, double-blind, placebo-controlled studies was conducted to evaluate the safety and tolerability of lumateperone 42mg (ITI-007 60mg).
Methods:
Data were pooled from the 3 controlled late-phase studies of lumateperone 42mg in patients with acute exacerbation of schizophrenia. Safety assessments of all patients who received at least one dose of any treatment included treatment-emergent adverse events (TEAEs), changes in laboratory parameters, extrapyramidal symptoms (EPS), and vital signs.
Results:
The safety population comprised 1,073 patients (placebo [n=412], lumateperone 42mg [n=406], risperidone [n=255]). TEAEs that occurred in the lumateperone 42mg group at a rate of ≥5% and twice placebo were somnolence/sedation (24.1% vs 10.0%) and dry mouth (5.9% vs 2.2%). Rates of discontinuation due to TEAEs with lumateperone 42mg (0.5%) were similar to placebo (0.5%) and lower than risperidone (4.7%). Mean change in weight and rates of EPS-related TEAEs were less for lumateperone 42mg and placebo patients than risperidone patients. Mean change from baseline in metabolic parameters were similar or smaller for lumateperone 42mg vs placebo. Mean changes were notably higher in risperidone patients vs lumateperone 42mg and placebo for glucose, cholesterol, triglycerides, and prolactin.
Conclusion:
In this pooled analysis, lumateperone 42mg showed good tolerability with potential benefits over risperidone for metabolic, prolactin, and EPS risks. The only TEAE that occurred in >10% of lumateperone patients was somnolence/sedation, which was impacted by morning administration; in subsequent studies that administered lumateperone in the evening, somnolence/sedation rates were markedly reduced. These results suggest that lumateperone 42mg may be a promising new treatment for schizophrenia.
Funding Acknowledgements:
Supported by funding from Intra-Cellular Therapies, Inc.
Sleep disturbances are prevalent in cancer patients, especially those with advanced disease. There are few published intervention studies that address sleep issues in advanced cancer patients during the course of treatment. This study assesses the impact of a multidisciplinary quality of life (QOL) intervention on subjective sleep difficulties in patients with advanced cancer.
Method
This randomized trial investigated the comparative effects of a multidisciplinary QOL intervention (n = 54) vs. standard care (n = 63) on sleep quality in patients with advanced cancer receiving radiation therapy as a secondary endpoint. The intervention group attended six intervention sessions, while the standard care group received informational material only. Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS), administered at baseline and weeks 4 (post-intervention), 27, and 52.
Results
The intervention group had a statistically significant improvement in the PSQI total score and two components of sleep quality and daytime dysfunction than the control group at week 4. At week 27, although both groups showed improvements in sleep measures from baseline, there were no statistically significant differences between groups in any of the PSQI total and component scores, or ESS. At week 52, the intervention group used less sleep medication than control patients compared to baseline (p = 0.04) and had a lower ESS score (7.6 vs. 9.3, p = 0.03).
Significance of results
A multidisciplinary intervention to improve QOL can also improve sleep quality of advanced cancer patients undergoing radiation therapy. Those patients who completed the intervention also reported the use of less sleep medication.
Background: Recruiting family physicians into primary care research studies requires researchers to continually manage information coming in, going out, and coming in again. In many research groups, Microsoft Excel and Access are the usual data management tools, but they are very basic and do not support any automation, linking, or reminder systems to manage and integrate recruitment information and processes. Objective: We explored whether a commercial customer relationship management (CRM) software program – designed for sales people in businesses to improve customer relations and communications – could be used to make the research recruitment system faster, more effective, and more efficient. Findings: We found that while there was potential for long-term studies, it simply did not adapt effectively enough for our shorter study and recruitment budget. The amount of training required to master the software and our need for ongoing flexible and timely support were greater than the benefit of using CRM software for our study.