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Background: The value of clinical pharmacists for ambulatory internal medicine clinics is well recognized, including their role in hemoglobin A1c (HbA1c) reduction in patients with type 2 diabetes mellitus (T2DM). However, there is a lack of data evaluating the clinical impact of remote, referral-based pharmacy programs. Methods: This multicenter, cohort, retrospective chart review study analyzed the impact of pharmacist interventions on blood glucose control in patients aged 18 years and older who were diagnosed with T2DM with an HbA1c of 8.5% or greater and referred to the clinical pharmacy team for medication evaluation. Primary care providers may have accepted or rejected pharmacist recommendations. The primary study outcome was the mean change in HbA1c from baseline to follow-up at 2 to 5 months. Secondary outcomes included appropriate use of American Diabetes Association-indicated secondary prevention and any occurrence of glycemia-related events (i.e., T2DM-related emergency room visits or hospitalizations). Results: At the conclusion of the study, the mean change in HbA1c from baseline to follow-up at 2 to 5 months was -2.7% and -0.6% for the accepted and rejected intervention groups, respectively (t = -2.94, P = 0.0068). Conclusions: The results of this study suggest that remote pharmacist intervention significantly improves blood glucose control in adults with T2DM.
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The deterioration of osteoblast-led bone formation and the upregulation of osteoclast-regulated bone resorption are the primary causes of bone diseases, including osteoporosis. Numerous circulating factors play a role in bone homeostasis by regulating osteoblast and osteoclast activity, including the sphingolipid-sphingosine-1-phosphate (S1P). However, to date no comprehensive studies have investigated the impact of S1P activity on human and murine osteoblasts and osteoclasts. We observed species-specific responses to S1P in both osteoblasts and osteoclasts, where S1P stimulated human osteoblast mineralisation and reduced human pre-osteoclast differentiation and mineral resorption, thereby favouring bone formation. The opposite was true for murine osteoblasts and osteoclasts, resulting in more mineral resorption and less mineral deposition. Species-specific differences in osteoblast responses to S1P were potentially explained by differential expression of S1P receptor 1. By contrast, human and murine osteoclasts expressed comparable levels of S1P receptors but showed differential expression patterns of the two sphingosine kinase enzymes responsible for S1P production. Ultimately, we reveal that murine models may not accurately represent how human bone cells will respond to S1P, and thus are not a suitable model for exploring S1P physiology or potential therapeutic agents.
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Diferenciación Celular , Lisofosfolípidos , Osteoblastos , Osteoclastos , Especificidad de la Especie , Esfingosina , Esfingosina/análogos & derivados , Esfingosina/metabolismo , Lisofosfolípidos/metabolismo , Humanos , Animales , Ratones , Osteoclastos/metabolismo , Osteoclastos/citología , Osteoblastos/metabolismo , Osteoblastos/efectos de los fármacos , Osteogénesis/efectos de los fármacos , Fosfotransferasas (Aceptor de Grupo Alcohol)/metabolismo , Fosfotransferasas (Aceptor de Grupo Alcohol)/genética , Receptores de Esfingosina-1-Fosfato/metabolismo , Huesos/metabolismo , Resorción Ósea/metabolismo , Células CultivadasRESUMEN
The existing suite of therapies for bone diseases largely act to prevent further bone loss but fail to stimulate healthy bone formation and repair. We describe an endogenous osteopeptide (PEPITEM) with anabolic osteogenic activity, regulating bone remodeling in health and disease. PEPITEM acts directly on osteoblasts through NCAM-1 signaling to promote their maturation and formation of new bone, leading to enhanced trabecular bone growth and strength. Simultaneously, PEPITEM stimulates an inhibitory paracrine loop: promoting osteoblast release of the decoy receptor osteoprotegerin, which sequesters RANKL, thereby limiting osteoclast activity and bone resorption. In disease models, PEPITEM therapy halts osteoporosis-induced bone loss and arthritis-induced bone damage in mice and stimulates new bone formation in osteoblasts derived from patient samples. Thus, PEPITEM offers an alternative therapeutic option in the management of diseases with excessive bone loss, promoting an endogenous anabolic pathway to induce bone remodeling and redress the imbalance in bone turnover.
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Resorción Ósea , Osteoblastos , Osteogénesis , Animales , Humanos , Osteoblastos/metabolismo , Osteoblastos/efectos de los fármacos , Osteogénesis/efectos de los fármacos , Ratones , Resorción Ósea/patología , Resorción Ósea/metabolismo , Anabolizantes/farmacología , Anabolizantes/uso terapéutico , Remodelación Ósea/efectos de los fármacos , Osteoporosis/patología , Osteoporosis/metabolismo , Osteoporosis/tratamiento farmacológico , Ligando RANK/metabolismo , Osteoclastos/metabolismo , Osteoclastos/efectos de los fármacos , Desarrollo Óseo/efectos de los fármacos , Osteoprotegerina/metabolismo , Femenino , Transducción de Señal/efectos de los fármacos , Péptidos/farmacología , Masculino , Ratones Endogámicos C57BL , Huesos/efectos de los fármacos , Huesos/metabolismo , Huesos/patologíaRESUMEN
BACKGROUND: Dementia is a common and progressive condition whose prevalence is growing worldwide. It is challenging for healthcare systems to provide continuity in clinical services for all patients from diagnosis to death. AIMS: To test whether individuals who are most likely to need enhanced care later in the disease course can be identified at the point of diagnosis, thus allowing the targeted intervention. METHOD: We used clinical information collected routinely in de-identified electronic patient records from two UK National Health Service (NHS) trusts to identify at diagnosis which individuals were at increased risk of needing enhanced care (psychiatric in-patient or intensive (crisis) community care). RESULTS: We examined the records of a total of 25 326 patients with dementia. A minority (16% in the Cambridgeshire trust and 2.4% in the London trust) needed enhanced care. Patients who needed enhanced care differed from those who did not in age, cognitive test scores and Health of the Nation Outcome Scale scores. Logistic regression discriminated risk, with an area under the receiver operating characteristic curve (AUROC) of up to 0.78 after 1 year and 0.74 after 4 years. We were able to confirm the validity of the approach in two trusts that differed widely in the populations they serve. CONCLUSIONS: It is possible to identify, at the time of diagnosis of dementia, individuals most likely to need enhanced care later in the disease course. This permits the development of targeted clinical interventions for this high-risk group.
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Demencia , Humanos , Demencia/terapia , Demencia/diagnóstico , Masculino , Femenino , Anciano , Estudios Retrospectivos , Anciano de 80 o más Años , Reino Unido , Datos de Salud Recolectados Rutinariamente , Servicios Comunitarios de Salud Mental , Persona de Mediana Edad , Registros Electrónicos de Salud/estadística & datos numéricos , Medición de RiesgoRESUMEN
BACKGROUND: Advance healthcare decision-making presumes that a prior treatment preference expressed with sufficient mental capacity ("T1 preference") should trump a contrary preference expressed after significant cognitive decline ("T2 preference"). This assumption is much debated in normative bioethics, but little is known about lay judgments in this domain. This study investigated participants' judgments about which preference should be followed, and whether these judgments differed depending on a first-person (deciding for one's future self) versus third-person (deciding for a friend or stranger) perspective. METHODS: A vignette-based survey was conducted (N = 1445 US Americans; gender-balanced sample), in a 3 (relationship: self, best friend, stranger) × 2 (T1 preference: treat, do not treat) × 2 (T2 contrary preference: ambiguous, unambiguous) design. RESULTS: Participants were more likely to defer to the incapacitated T2 preference of a third-party, while being more likely to insist on following their own T1 capacitated preference. Further, participants were more likely to conclude that others with substantial cognitive decline were still their "true selves," which correlated with increased deference to their T2 preferences. CONCLUSIONS: These findings add to the growing evidence that lay intuitions concerning the ethical entitlement to have decisions respected are not only a function of cognition, as would be expected under many traditional bioethical accounts, but also depend on the relationship of the decision to the decision-maker's true self.
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PURPOSE: To examine associations between sociodemographic variables, social determinants of health (SDOHs) and diabetes using health needs assessment data. DESIGN: Cross-sectional study. SETTING: Faith-based communities in the Mid-South U.S. SAMPLE: Of the 378 churches, 92 participated in the study (24% response rate); N = 828 church leaders and members completed the survey. MEASURE: The Mid-South Congregational Health Survey assessed perceived health-related needs of congregations and the communities they serve. ANALYSIS: Generalized linear mixed modeling examined the associations between sociodemographic variables (age, sex, race/ethnicity, educational level), SDOHs (affordable healthcare, healthy food, employment), and diabetes. RESULTS: Individuals with less education had lower odds of reporting all SDOHs as health needs compared to individuals with more education (ORrange = .59-.63). Men had lower odds of reporting diabetes as a health need or concern compared to women (OR = .70; 95% CI = .50, .97). African Americans had greater odds of reporting diabetes as a health need compared to individuals in the 'Other' race/ethnicity category (OR = 3.91; 95% CI = 2.20, 6.94). Individuals who reported affordable healthcare (OR = 2.54; 95% CI = 1.73, 3.72), healthy food (OR = 2.24; 95% CI = 1.55, 3.24), and employment (OR = 3.33; 95% CI = 2.29, 4.84) as health needs had greater odds of reporting diabetes as a health need compared to those who did not report these SDOHs as needs. CONCLUSIONS: Future studies should evaluate strategies to merge healthcare and faith-based organizations' efforts to address SDOHs impacting diabetes.
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Diabetes Mellitus , Evaluación de Necesidades , Determinantes Sociales de la Salud , Humanos , Masculino , Femenino , Estudios Transversales , Persona de Mediana Edad , Diabetes Mellitus/epidemiología , Adulto , Anciano , Factores Sociodemográficos , Factores Socioeconómicos , Factores Sexuales , ReligiónRESUMEN
BACKGROUND: Phase three trials of the monoclonal antibodies lecanemab and donanemab, which target brain amyloid, have reported statistically significant differences in clinical end-points in early Alzheimer's disease. These drugs are already in use in some countries and are going through the regulatory approval process for use in the UK. Concerns have been raised about the ability of healthcare systems, including those in the UK, to deliver these treatments, considering the resources required for their administration and monitoring. AIMS: To estimate the scale of real-world demand for monoclonal antibodies for Alzheimer's disease in the UK. METHOD: We used anonymised patient record databases from two National Health Service trusts for the year 2019 to collect clinical, demographic, cognitive and neuroimaging data for these cohorts. Eligibility for treatment was assessed using the inclusion criteria from the clinical trials of donanemab and lecanemab, with consideration given to diagnosis, cognitive performance, cerebrovascular disease and willingness to receive treatment. RESULTS: We examined the records of 82 386 people referred to services covering around 2.2 million people. After applying the trial criteria, we estimate that a maximum of 906 people per year would start treatment with monoclonal antibodies in the two services, equating to 30 200 people if extrapolated nationally. CONCLUSIONS: Monoclonal antibody treatments for Alzheimer's disease are likely to present a significant challenge for healthcare services to deliver in terms of the neuroimaging and treatment delivery. The data provided here allows health services to understand the potential demand and plan accordingly.
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Enfermedad de Alzheimer , Humanos , Enfermedad de Alzheimer/tratamiento farmacológico , Reino Unido , Masculino , Anciano , Femenino , Anciano de 80 o más Años , Anticuerpos Monoclonales/uso terapéutico , Anticuerpos Monoclonales Humanizados/uso terapéutico , Necesidades y Demandas de Servicios de Salud/estadística & datos numéricos , Persona de Mediana EdadRESUMEN
Needs assessments have been successful in helping communities and congregations focus their health ministry efforts; however, most have used leader perceptions of congregational health needs. The purpose of this study was to examine and compare the self-reported needs of both church leaders and members to be addressed by their congregation. Church leaders (n = 369) and members (n = 459) from 92 congregations completed the 2019 Mid-South Congregational Health Survey. Frequencies and generalized linear mixed models (GLMM) were performed to examine the top 10 self-reported needs and associations by church role, respectively. Of the top 10 congregational needs, anxiety or depression, high blood pressure, stress, and healthy foods were ranked identically regardless of church role. Church leaders perceived obesity and diabetes to be important congregational health needs, whereas members perceived affordable health care and heart disease to be important congregational health needs. GLMM, controlling for within-church clustering and covariates, revealed church leaders were more likely than members to report obesity (odds ratio [OR]: 1.93, 95% confidence interval [CI] = [1.39, 2.67], p < .0001) and diabetes (OR: 1.73, 95% CI = [1.24, 2.41], p = .001) as congregational needs. Findings display similarities and differences in needs reported by church role. Including many perspectives when conducting congregational health needs assessments will assist the development of effective faith-based health promotion programs.
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Diabetes Mellitus , Análisis de Datos Secundarios , Humanos , Promoción de la Salud , Encuestas Epidemiológicas , Obesidad/prevención & control , Estado de SaludRESUMEN
In England, children and adolescents with depression can seek treatment from specialist mental health services. We know little about how they journey through these services, or whether healthcare providers collect sufficient data to accurately appraise this. We aimed to summarise the child and adolescent depression pathway for two healthcare providers. This cohort study used de-identified electronic health records extracted from Cambridgeshire and Peterborough NHS Foundation Trust (CPFT) and South London and Maudsley NHS Foundation Trust (SLaM). We identified referrals between 2015 and 2019 during which the referred patient received their first depression diagnosis aged < 18 years. We described patient demographic and clinical characteristics, and features of the referral. In total, n = 296 (CPFT) and n = 2502 (SLaM) patients had a referral which met eligibility criteria. In both sites, patients were more frequently female (CPFT 79.3%; SLaM 69.3%) and White ethnicity (CPFT 88.9%; SLaM 57.9%) as compared to respective population estimates for the Trusts' catchment areas. Patients typically received their first depression diagnosis during adolescence (median ages 16 in CPFT and 15 in SLaM). The most common comorbidity was anxiety disorder. Referrals were usually routine, to community teams specialising in the child age group. Commonly mentioned interventions included antidepressant medication, cognitive behavioural therapy, and dialectical behaviour therapy. However, pathways varied within and between sites, and the quality and consistency of some data was poor. These findings provide an overview of service pathways experienced by children and adolescents with depression, but also highlight that pathways can vary according to individual need and healthcare provider. More systematic collection of some data, and standardisation in record systems used by different providers, would be beneficial.
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BACKGROUND: Drinking water is a common source of exposure to inorganic arsenic. In the US, the Safe Drinking Water Act (SDWA) was enacted to protect consumers from exposure to contaminants, including arsenic, in public water systems (PWS). The reproductive effects of preconception and prenatal arsenic exposure in regions with low to moderate arsenic concentrations are not well understood. OBJECTIVES: This study examined associations between preconception and prenatal exposure to arsenic violations in water, measured via residence in a county with an arsenic violation in a regulated PWS during pregnancy, and five birth outcomes: birth weight, gestational age at birth, preterm birth, small for gestational age (SGA), and large for gestational age (LGA). METHODS: Data for arsenic violations in PWS, defined as concentrations exceeding 10 parts per billion, were obtained from the Safe Drinking Water Information System. Participants of the Environmental influences on Child Health Outcomes Cohort Study were matched to arsenic violations by time and location based on residential history data. Multivariable, mixed effects regression models were used to assess the relationship between preconception and prenatal exposure to arsenic violations in drinking water and birth outcomes. RESULTS: Compared to unexposed infants, continuous exposure to arsenic from three months prior to conception through birth was associated with 88.8 g higher mean birth weight (95% CI: 8.2, 169.5), after adjusting for individual-level confounders. No statistically significant associations were observed between any preconception or prenatal violations exposure and gestational age at birth, preterm birth, SGA, or LGA. CONCLUSIONS: Our study did not identify associations between preconception and prenatal arsenic exposure, defined by drinking water exceedances, and adverse birth outcomes. Exposure to arsenic violations in drinking water was associated with higher birth weight. Future studies would benefit from more precise geodata of water system service areas, direct household drinking water measurements, and exposure biomarkers.
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Arsénico , Agua Potable , Nacimiento Prematuro , Efectos Tardíos de la Exposición Prenatal , Embarazo , Lactante , Niño , Femenino , Humanos , Recién Nacido , Peso al Nacer , Arsénico/toxicidad , Arsénico/análisis , Estudios de Cohortes , Nacimiento Prematuro/inducido químicamente , Nacimiento Prematuro/epidemiología , Agua Potable/análisis , Retardo del Crecimiento Fetal , Exposición Materna/efectos adversosRESUMEN
"Bodily autonomy" has received significant attention in bioethics, medical ethics, and medical law in terms of the general inviolability of a patient's bodily sovereignty and the rights of patients to make choices (e.g., reproductive choices) that concern their own body. However, the role of the body in terms of how it can or does contribute to a patient's capacity for, or exercises of their autonomy in clinical decision-making situations has not been explicitly addressed. The approach to autonomy in this paper is aligned with traditional theories that conceive autonomy in terms of an individual's capacities for, and exercises of rational reflection. However, at the same time, this paper extends these accounts by arguing that autonomy is, in part, embodied. Specifically, by drawing on phenomenological conceptions of the experience of autonomy, we argue that, in principle, the body is a necessary component of the capacity for autonomy. Secondly, through the presentation of two different cases, we highlight ways in which a patient's body can contribute to the autonomy of treatment choices. Ultimately, we hope to encourage others to explore additional conditions under which a concept of embodied autonomy should be employed in medical decision making, how its underlying principles might be operationalised in clinical situations, and its consequences for approaches to patient autonomy in healthcare practice, policy, and law.
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Bioética , Humanos , Toma de Decisiones Clínicas , Ética Médica , PolíticasRESUMEN
BACKGROUND: Epidemiological research may require linkage of information from multiple organizations. This can bring two problems: (1) the information governance desirability of linkage without sharing direct identifiers, and (2) a requirement to link databases without a common person-unique identifier. METHODS: We develop a Bayesian matching technique to solve both. We provide an open-source software implementation capable of de-identified probabilistic matching despite discrepancies, via fuzzy representations and complete mismatches, plus de-identified deterministic matching if required. We validate the technique by testing linkage between multiple medical records systems in a UK National Health Service Trust, examining the effects of decision thresholds on linkage accuracy. We report demographic factors associated with correct linkage. RESULTS: The system supports dates of birth (DOBs), forenames, surnames, three-state gender, and UK postcodes. Fuzzy representations are supported for all except gender, and there is support for additional transformations, such as accent misrepresentation, variation for multi-part surnames, and name re-ordering. Calculated log odds predicted a proband's presence in the sample database with an area under the receiver operating curve of 0.997-0.999 for non-self database comparisons. Log odds were converted to a decision via a consideration threshold θ and a leader advantage threshold δ. Defaults were chosen to penalize misidentification 20-fold versus linkage failure. By default, complete DOB mismatches were disallowed for computational efficiency. At these settings, for non-self database comparisons, the mean probability of a proband being correctly declared to be in the sample was 0.965 (range 0.931-0.994), and the misidentification rate was 0.00249 (range 0.00123-0.00429). Correct linkage was positively associated with male gender, Black or mixed ethnicity, and the presence of diagnostic codes for severe mental illnesses or other mental disorders, and negatively associated with birth year, unknown ethnicity, residential area deprivation, and presence of a pseudopostcode (e.g. indicating homelessness). Accuracy rates would be improved further if person-unique identifiers were also used, as supported by the software. Our two largest databases were linked in 44 min via an interpreted programming language. CONCLUSIONS: Fully de-identified matching with high accuracy is feasible without a person-unique identifier and appropriate software is freely available.
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Registro Médico Coordinado , Privacidad , Humanos , Masculino , Teorema de Bayes , Medicina Estatal , Programas InformáticosRESUMEN
BACKGROUND: Previous studies have shown reduced survival in Lewy body dementia (LBD) compared to Alzheimer's disease (AD), but the reasons for this are not known. We identified cause of death categories accounting for the reduced survival in LBD. METHODS: We linked cohorts of patients with dementia with Lewy bodies (DLB), Parkinson's disease dementia (PDD) and AD, with proximal cause of death data. We examined mortality by dementia group and hazard ratios for each death category by dementia group in males and females separately. In a specific focus on the dementia group with the highest mortality rate versus reference, we examined cumulative incidence to identify the main causes of death accounting for the excess deaths. RESULTS: Hazard ratios for death were higher in PDD and DLB compared to AD, for both males and females. PDD males had the highest hazard ratio for death across the dementia comparison groups (HR 2.7, 95% CI 2.2-3.3). Compared with AD, hazard ratios for "nervous system" causes of death were significantly elevated in all LBD groups. Additional significant cause-of-death categories included aspiration pneumonia, genitourinary causes, other respiratory causes, circulatory and a "symptoms and signs" category in PDD males; other respiratory causes in DLB males; mental disorders in PDD females; and aspiration pneumonia, genitourinary and other respiratory causes in DLB females. CONCLUSION: Further research and cohort development is required to investigate differences by age group, to extend cohort follow-up to the whole population and to investigate the risk-balance of interventions which may differ by dementia group.
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Enfermedad de Alzheimer , Demencia , Enfermedad por Cuerpos de Lewy , Enfermedad de Parkinson , Neumonía por Aspiración , Masculino , Femenino , Humanos , Enfermedad de Alzheimer/complicaciones , Enfermedad por Cuerpos de Lewy/complicaciones , Demencia/complicaciones , Causas de Muerte , Enfermedad de Parkinson/psicología , Estudios Longitudinales , Salud Mental , Atención Secundaria de Salud , Neumonía por Aspiración/complicacionesRESUMEN
Around a quarter of people who experience a first episode of psychosis (FEP) will develop treatment-resistant schizophrenia (TRS), but there are currently no established clinically useful methods to predict this from baseline. We aimed to explore the predictive potential for clozapine use as a proxy for TRS of routinely collected, objective biomedical predictors at FEP onset, and to externally validate the model in a separate clinical sample of people with FEP. We developed and externally validated a forced-entry logistic regression risk prediction Model fOr cloZApine tReaTment, or MOZART, to predict up to 8-year risk of clozapine use from FEP using routinely recorded information including age, sex, ethnicity, triglycerides, alkaline phosphatase levels, and lymphocyte counts. We also produced a least-absolute shrinkage and selection operator (LASSO) based model, additionally including neutrophil count, smoking status, body mass index, and random glucose levels. The models were developed using data from two UK psychosis early intervention services (EIS) and externally validated in another UK EIS. Model performance was assessed via discrimination and calibration. We developed the models in 785 patients, and validated externally in 1,110 patients. Both models predicted clozapine use well at internal validation (MOZART: C 0.70; 95%CI 0.63,0.76; LASSO: 0.69; 95%CI 0.63,0.77). At external validation, discrimination performance reduced (MOZART: 0.63; 0.58,0.69; LASSO: 0.64; 0.58,0.69) but recovered after re-estimation of the lymphocyte predictor (C: 0.67; 0.62,0.73). Calibration plots showed good agreement between observed and predicted risk in the forced-entry model. We also present a decision-curve analysis and an online data visualisation tool. The use of routinely collected clinical information including blood-based biomarkers taken at FEP onset can help to predict the individual risk of clozapine use, and should be considered equally alongside other potentially useful information such as symptom scores in large-scale efforts to predict psychiatric outcomes.
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Purpose: The aim of this study was to apply the Six Sigma methodology and failure mode and effect analysis (FMEA) to mitigate errors in intensity modulated radiation therapy (IMRT) and stereotactic body radiation therapy (SBRT) treatment planning with the first clinical installation of RefleXion X1. Methods and Materials: The Six Sigma approach consisted of 5 phases: define, measure, analyze, improve, and control. The define, measure, and analyze phases consisted of process mapping and an FMEA of IMRT and SBRT treatment planning on the X1. The multidisciplinary team outlined the workflow process and identified and ranked the failure modes associated with the plan check items using the American Association of Physicists in Medicine Task Group 100 recommendations. Items with the highest average risk priority numbers (RPNs) and severity ≥7 were prioritized for automation using the Eclipse Scripting Application Programming Interface (ESAPI). The "improve" phase consisted of developing ESAPI scripts before the clinical launch of X1 to improve efficiency and safety. In the "control" phase, the FMEA ranking was re-evaluated 1 year after clinical launch. Results: Overall, 100 plan check items were identified in which the RPN values ranged from 10.2 to 429.0. Fifty of these items (50%) were suitable for automation within ESAPI. Of the 10 highest-risk items, 8 were suitable for automation. Based on the results of the FMEA, 2 scripts were developed: Planning Assistant, used by the planner during preparation for planning, and Automated Plan Check, used by the planner and the plan checker during plan preparation for treatment. After 12 months of clinical use of the X1 and developed scripts, only 3 errors were reported. The average prescript RPN was 138.0, compared with the average postscript RPN of 47.8 (P < .05), signifying a safer process. Conclusions: Implementing new technology in the clinic can be an error-prone process in which the likelihood of errors increases with increasing pressure to implement the technology quickly. To limit errors in clinical implementation of the novel RefleXion X1 system, the Six Sigma method was used to identify failure modes, establish quality control checks, and re-evaluate these checks 1 year after clinical implementation.
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Investigación Biomédica , Consentimiento Informado , Humanos , Autonomía Personal , Ética MédicaRESUMEN
Research on organoids has undergone significant advances during the last decade. However, outcomes from the use of organoids in clinical trials have not yet been documented. Therefore, there is an urgent need to assess the reporting of clinically relevant outcomes from organoid research in the scientific literature. This article presents a systematic review and appraisal of the published literature in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, together with a synopsis of recent relevant reviews. Surprisingly, no randomized controlled trials have reported clinical outcomes with any types of organoids. We found very few ongoing and registered studies that may provide clinically relevant results within this decade. Our screening and interpretation of the literature, including review articles, indicate a focus on technical and preclinical aspects of organoid research. This is the first systematic review of clinical trials involving organoids. Few clinical studies are planned or already underway, and, so far, no high-quality evidence relating to the clinical outcomes of organoid research has been published. The many promises of organoid research still need to be translated from bench to bed.