Important Medical Decisions Research Articles

Abstract 4120249: What Happens to Automated External Defibrillator Rhythm Strips after a Cardiac Arrest?

Background: Following an out of hospital cardiac arrest (OHCA), rhythm strips stored on an automated external defibrillator (AED) help guide important medical decisions, including possible implantable cardioverter defibrillator (ICD) implantation. However, this information is often difficult to obtain. Objective: To evaluate how frequently AED rhythm strips are reviewed following an OHCA prior to placing an ICD. Methods: Using the Cardiac Arrest Registry to Enhance Survival (CARES), we identified patients from 1/2015-12/2023 who were transferred to our institution following an OHCA. Patients were excluded if resuscitation was not attempted, death occurred during the hospitalization or patient identifying information was not available. Results: Of 907 OHCAs identified, 119 patients ( Table 1 ) met the inclusion criteria. The AED rhythm strip was in the electronic medical record on hospital arrival in 22% of cases and only after provider initiation in 6% of cases. None of the rhythm strips from a bystander-only delivered AED shock (n=17) were available on arrival, with only 24% retrieved during the hospitalization, taking 4.5±2.1 days from the date of arrest. Patients with an AED rhythm strip available (n=34) were more likely than those without a rhythm strip (n=85) to have a cardiac MRI (38% v. 13%, p=0.02) and genetic testing (15% v. 1%, p=0.02) done and have an ICD placed (53% v. 27%, p=0.04) or be discharged on a new anti-arrhythmic drug (15% v. 4%, p=0.04). Figure 1 Of the 42 patients who had an ICD placed during the index hospitalization, 54% were implanted without knowing the type of shockable rhythm or confirmation that an appropriate AED shock had been delivered. Conclusion: Rhythm strips help guide clinical decisions when assessing the need for ICD implantation. There is a systems gap in the process of transferring rhythm strips from AEDs to hospital providers following an OHCA.

Перспективи застосування штучного інтелекту в стоматології

Introduction. In recent years, artificial intelligence (AI) has found widespread use in healthcare and dentistry, where it has increased the accuracy of diagnosis and clinical decision-making. However, artificial intelligence solutions have largely not entered everyday dental practice, mainly due to limited data availability, accessibility, structure and complexity, lack of methodological rigor and standards in their development, and practical questions regarding the value and utility of these solutions, but also ethics and liability. Any application of artificial intelligence in dentistry must demonstrate tangible value, such as improving access and quality of care, increasing efficiency and safety of services, empowering patients and supporting medical research, or increasing sustainability. Purpose: based on the analysis of literary sources, to determine the prospects and feasibility of implementing the use of artificial intelligence in dentistry. Materials and methods. Information search and analysis of scientific sources was carried out using scientometric databases Web of Science, PubMed, Google Scholar over the last 10 years. Conclusion. The next decade will show whether this time the expectations for real-world applications of artificial intelligence will be met, or whether we will once again face an «AI winter» that will bury hopes and enthusiasm. There are valid concerns about the protection and security of data and the transfer of important medical decisions to computers. At the same time, artificial intelligence has the potential to revolutionize the health care industry, including dentistry, by helping to address the shortcomings of traditional dental care, which have been heavily criticized. Keywords: dentistry, artificial intelligence, deep learning, diagnostics and clinical decision-making.

GERONTOLOGICAL ASPECTS AND PALLIATIVE CARE IN FAMILY MEDICINE

This article presents a literature analysis on the gerontological aspects of comorbidity and the provision of palliative care in the practice of a family doctor. According to the UN, in 2020, the age of almost every tenth inhabitant of the Earth exceeded 65 years. In 2050, their share will increase from 9.3% to 15.9%. The share of people aged 60 and over will make up to one third of the global population. Analysis of referrals to outpatient polyclinic institutions shows that, in general, for all classes of diseases and individual diseases, the highest percentage of referrals to a doctor is observed in groups of 70 years and older. In old age, both physiological and pathological aging are accompanied by structural and functional changes of all organs and systems, hemodynamic disturbances, deterioration of blood supply to tissues, increased risk of hypoxia with early activation of anaerobic mechanisms. Among those who seek medical help from a family doctor in Ukraine, the share of elderly patients with combined pathology is more than 80%. Elderly people with comorbid conditions experience pain more frequently than those in other age groups. One of the primary medical, social and humanitarian problems of many countries throughout the world is the creation and development of an accessible and effective system of providing palliative care to the population. These problems arose due to an increase in the number of incurable patients with a limited life expectancy. Based on the analysis of the experience of different countries, it is convincingly clear that palliative and hospice care best provides the needs and proper quality of life of palliative patients and their relatives, contributes to the preservation of human dignity at the end of biological life. The goal of palliative care is to alleviate the suffering of patients and their families by comprehensively assessing and treating the physical, psychosocial, and spiritual symptoms experienced by patients. Palliative care focuses on predicting, preventing, diagnosing, and treating the symptoms experienced by patients with serious or life-threatening illness, and on helping patients and their families make important medical decisions. A family doctor is recognized as a specialist in the medical field who can most fully influence the health of the population. Family doctors provide palliative care, they consult, educate relatives and friends of the patient about the patient's needs, provide psychological and moral support to both the patient and his family.

Dentistry and incapacity

Our Legal editor explores the issue of capacity when making important medical decisions about treatment.

Predicting Patient Demographics From Chest Radiographs With Deep Learning.

Deep learning models are increasingly informing medical decision making, for instance, in the detection of acute intracranial hemorrhage and pulmonary embolism. However, many models are trained on medical image databases that poorly represent the diversity of the patients they serve. In turn, many artificial intelligence models may not perform as well on assisting providers with important medical decisions for underrepresented populations. Assessment of the ability of deep learning models to classify the self-reported gender, age, self-reported ethnicity, and insurance status of an individual patient from a given chest radiograph. Models were trained and tested with 55,174 radiographs in the MIMIC Chest X-ray (MIMIC-CXR) database. External validation data came from two separate databases, one from CheXpert and another from a multihospital urban health care system after institutional review board approval. Macro-averaged area under the curve (AUC) values were used to evaluate performance of models. Code used for this study is open-source and available at https://github.com/ai-bias/cxr-bias, and pixelstopatients.com/models/demographics. Accuracy of models to predict gender was nearly perfect, with 0.999 (95% confidence interval: 0.99-0.99) AUC on held-out test data and 0.994 (0.99-0.99) and 0.997 (0.99-0.99) on external validation data. There was high accuracy to predict age and ethnicity, ranging from 0.854 (0.80-0.91) to 0.911 (0.88-0.94) AUC, and moderate accuracy to predict insurance status, with AUC ranging from 0.705 (0.60-0.81) on held-out test data to 0.675 (0.54-0.79) on external validation data. Deep learning models can predict the age, self-reported gender, self-reported ethnicity, and insurance status of a patient from a chest radiograph. Visualization techniques are useful to ensure deep learning models function as intended and to demonstrate anatomical regions of interest. These models can be used to ensure that training data are diverse, thereby ensuring artificial intelligence models that work on diverse populations.

Evidence-based Shared-Decision-Making Assistant (SDM-assistant) for choosing antipsychotics: protocol of a cluster-randomized trial in hospitalized patients with schizophrenia

BackgroundChoosing an antipsychotic medication is an important medical decision in the treatment of schizophrenia. This decision requires risk-benefit assessments of antipsychotics, and thus, shared-decision making between physician and patients is strongly encouraged. Although the efficacy and side-effect profiles of antipsychotics are well-established, there is no clear framework for the communication of the evidence between physicians and patients. For this reason, we developed an evidence-based shared-decision making assistant (SDM-assistant) that presents high-quality evidence from network meta-analysis on the efficacy and side-effect profile of antipsychotics and can be used as a basis for shared-decision making between physicians and patients when selecting antipsychotic medications.MethodsThe planned matched-pair cluster-randomised trial will be conducted in acute psychiatric wards (n = 14 wards planned) and will include adult inpatients with schizophrenia or schizophrenia-like disorders (N = 252 participants planned). On the intervention wards, patients and their treating physicians will use the SDM-assistant, whenever a decision on choosing an antipsychotic is warranted. On the control wards, antipsychotics will be chosen according to treatment-as-usual. The primary outcome will be patients’ perceived involvement in the decision-making during the inpatient stay as measured with the SDM-Q-9. We will also assess therapeutic alliance, symptom severity, side-effects, treatment satisfaction, adherence, quality of life, functioning and rehospitalizations as secondary outcomes. Outcomes could be analysed at discharge and at follow-up after three months from discharge. The analysis will be conducted per-protocol using mixed-effects linear regression models for continuous outcomes and logistic regression models using generalised estimating equations for dichotomous outcomes. Barriers and facilitators in the implementation of the intervention will also be examined using a qualitative content analysis.DiscussionThis is the first trial to examine a decision assistant specifically designed to facilitate shared-decision making for choosing antipsychotic medications, i.e., SDM-assistant, in acutely ill inpatients with schizophrenia. If the intervention can be successfully implemented, SDM-assistant could advance evidence-based medicine in schizophrenia by putting medical evidence on antipsychotics into the context of patient preferences and values. This could subsequently lead to a higher involvement of the patients in decision-making and better therapy decisions.Trial registrationGerman Clinical Trials Register (ID: DRKS00027316, registration date 26.01.2022).

Emerging Marketing Research on Healthcare and Medical Decision Making: Toward a Consumer-Centric and Pluralistic Methodological Perspective

Emerging Marketing Research on Healthcare and Medical Decision Making: Toward a Consumer-Centric and Pluralistic Methodological Perspective

Abstract WP225: Composition Of Egocentric Networks Among Stroke Survivors

Background: Social networks provide emotional and social support that may help prevent the onset of secondary stroke. Little is known about egocentric networks among stroke survivors and the type of support they provide. Objective: To develop an understanding of the supportive role alters or personal contacts provide to stroke survivors and gain insight of participants' egocentric network. Methods: Data obtained from the Discharge Educational Strategies for Reduction of Vascular Events (DESERVE) trial, a skills-based, culturally tailored discharge educational intervention. Participants (n=552) identified up to 5 alters. Descriptive analyses were conducted to assess the relationship between participants and alters. Results: Approximately, 34% of participants identified as Non-Hispanic (NH) Black followed by Hispanic (33%), NH White (28%), NH Asian Pacific Islanders (API) (3%). Majority of participants (n=462, 83%) reported having at least one alter. Most participants with ≥1 alter (92%) indicated talking to alter every day or several times a week. Yet all with an alter stated that they can talk to alter about an important health problem or medical decision. Among participants (n=543, p=.002), NH Blacks (n=38, 45%) and Hispanic (n=33, 39%) were more likely to report no alters compared to NH White (n=14, 16%; Figure). Conclusions: Majority of participants reported having at least one person within their social network that they can talk to about their health problems. We are unable to determine if the first person that participants indicated may be the most influential person in health-related matters. The implications of these results may be relevant for future stroke interventions. Additional studies are needed to understand the type of influence alters have on stroke survivors in health-related behaviors and decisions that may help improve post-stroke outcomes. Further studies are also needed to assess health outcomes among isolated stroke patients by race.

Utility-Based Multicriteria Model for Screening Patients under the COVID-19 Pandemic.

In this paper, a utility-based multicriteria model is proposed to support the physicians to deal with an important medical decision—the screening decision problem—given the squeeze put on resources due to the COVID-19 pandemic. Since the COVID-19 emerged, the number of patients with an acute respiratory failure has increased in the health units. This chaotic situation has led to a deficiency in health resources. Thus, this study, using the concepts of the multiattribute utility theory (MAUT), puts forward a mathematical model to aid physicians in the screening decision problem. The model is used to generate which of the three alternatives is the best one for where patients with suspected COVID-19 should be treated, namely, an intensive care unit (ICU), a hospital ward, or at home in isolation. Also, a decision information system, called SIDTriagem, is constructed and illustrated to operate the mathematical model proposed.

A Survey of Antenatal and Peripartum Provision of Information on Analgesia and Anesthesia

(Anaesthesia. 2019;74:1101–1111) Women in labor often need to make important medical decisions quickly, and experiencing a lack of control or undergoing unplanned procedures can contribute to a negative birth experience. While laboring women are capable of discussing treatment options and making these decisions, information regarding anesthetic care should ideally be given to patients well before these decisions must be made. Previous studies in the United Kingdom have found that ∼45% of expectant mothers participate in antenatal classes while 75% use the Internet to find information on obstetric analgesia and anesthesia. Only 31% were aware of the National Health Service’s information for parents Web site. This large multicenter study examined the provision of anesthesia information to pregnant women in London hospitals.

An Alternative Perspective on Rationing Ventilators

The COVID-19 pandemic has resulted in discussion on how to allocate scarce medical resources such as ventilators. Some bioethicists have suggested that difficult determinations about withholding or withdrawing treatment should be made by triage officers or committees to alleviate the psychological strain on frontline clinicians. However, this raises concerns about shifting important personal medical decisions away from physicians and their patients. According to the principle of subsidiarity, frontline clinicians, together with their patients, should be making these decisions, with ethics committees or triage committees serving only in an advisory capacity. Several ethical principles can help health care professionals allocate scarce resources. These include basing exclusion criteria on clinical status rather than nonmedical characteristics; randomizing treatment for clinically similar patients; obtaining free and informed consent when considering the withdrawal of treatment, even in situations where treatment is possibly futile; and emphasizing quality palliative care for all patients.

Who Are “Unrepresented” Patients and What Count as “Important” Medical Decisions for Them?

Unrepresented patients are hospital patients who lack decision-making capacity but have no advance directive and no one to serve as a legally authorized surrogate. An important first step in efforts to change the law and develop organizational policies that help respond to these patients' needs is determining which patients should be considered unrepresented and which aspects of hospital care should receive attention. This article proposes working definitions of unrepresented patient and important medical decisions based on the work of one statewide initiative, the Unrepresented Patients Project for Illinois.

STANDARDIZATION AS AN APPROACH TO IMPROVING THE QUALITY OF CLINICAL AND LABORATORY WORK

Standardization is defined as an activity that regulates the general and repetitive application of a system of prescriptions on different (including specific) issues in order to achieve optimal order in certain circumstances. It involves the creation, dissemination and implementation of standards aimed at improving the common properties (quality, suitability, etc.) of products, processes and services. Standards are documents that contain rules, norms, and requirements for a product or service, in order to achieve better efficiency and meet the expectations of consumers and customers. Standards are means of information, serving to improve quality, to support the economic development and contributing to the benefit of the whole Society. The term ‘Standard’ is at the core of the standardization process. Applied to the health system, the standard is a regulatory document developed on the basis of different consensus and validated by a relevant body. This regulatory document establishes a set of rules and requirements concerning different types of medical activities and the results of their implementation. An important objective of each healthcare system is to provide the population with accessible, quality and safe medical care. The introduction of a system of standards in healthcare and in medicine, in particular, is a powerful tool for its achievement. This ensures high quality of the medical assistance offered, a rational use of financial, material and personnel resources as well as an optimization of the diagnostic and healing process. Standards set a minimum/optimal level of Quality Assurance through mandatory requirements that are the basis of State guarantees for affordable medical care, range and types of health services, lists of specific technologies with proven effectiveness, as well as guidelines to further improve the level of quality by formulating further scientifically substantiated recommendations. Standards allow for aggregation of information, which leads to optimization of solutions at all levels in the healthcare system. Standardization is one of the main means of achieving and maintaining the necessary level and one of the main tools in Quality Management. In laboratory medicine, standardization is an approach for the optimization of clinical and laboratory activities. The provision of high quality services is the responsibility of every professional working in the respective diagnostic structure. The quality and standardization in the Specialization of “Clinical Laboratory” are focused not only on the accuracy of laboratory results, but also they step on a broader basis, including each stage of the clinical and laboratory analysis, in order to make important medical decisions subject to patient care.

Competence to Consent and Its Relationship With Cognitive Function in Patients With Schizophrenia.

Decisional capacity to consent is an emerging ethical and legal concept, and is closely related to self-determination of patients facing important medical decisions or research participations. Recently, the MacArthur Competence Assessment Tool (MacCAT), a semi-structured interview consisting of four dimensions (Understanding, Appreciation, Reasoning, and Expression of a Choice), was developed to assess the decisional capacity. Decision-making capacity in a group of patients with schizophrenia, as measured by the MacCAT, has been shown to be impaired in comparison with healthy control people. However, this does not necessarily mean the presence of impaired decisional capacity in all cases. Considering the real-world practice of obtaining informed consent from patients with schizophrenia, it is important to evaluate the relationship between psychopathological features and decisional capacity of the illness. Negative symptoms of schizophrenia have been demonstrated to be related to the ability to understand information relevant to the decision, reason rationally, and appreciate a situation and its consequences. On the other hand, positive symptoms, such as delusions and hallucinations have been an inconsistent correlate of poor capacity. Furthermore, some studies indicate that impairment of cognitive function, a core symptom of schizophrenia, could be more largely associated with decisional capacity than positive and negative symptoms. Therefore, it is reasonable to assume cognitive enhancement would enlarge the capacity to consent and promote autonomy in medical treatment and research participation in patients with schizophrenia. Further studies are warranted to elucidate this and related issues.

PC-FACS

PC-FACS

Primary Care and Emergency Department Management of the Patient With Duchenne Muscular Dystrophy

Primary care providers (PCPs) are usually the first point of contact with the health care system for patients with Duchenne muscular dystrophy (DMD), and patients often present to emergency departments in which providers have little experience in dealing with this condition. With this article, we give primary care and emergency medicine providers a background in the common issues that affect people with DMD. By acquiring some specialized knowledge about the multisystem medical complications of DMD and by applying general principles of primary care, such as timely immunization, anticipatory safety counseling, behavioral screening, and routine nutritional and developmental assessments, the PCP can be a valued and effective medical provider to patients with DMD. The PCP can provide access to and effective coordination among the patient's specialty caregivers. Moreover, the PCP can become a trusted advisor to the patient and his family about important medical decisions, as well as issues in the psychosocial, behavioral, and educational domains. This article also contains a "pocket guide" used to assess and manage common urgent medical problems that cause patients with DMD to seek care in the emergency department. With the background information discussed in this article, both PCPs and emergency medicine physicians can skillfully care for patients with DMD in their respective settings, optimizing patient outcomes.

1719P - Prevention and prophylaxis of thrombosis in cancer patients

Background: Cancer Associated Thrombosis (CAT) is a significant problem in oncology that is underestimated sometimes. Venus ThomboEmbolism (VTE) is the 2nd cause of death in cancer patients. Currently, the standard of care not only for the treatment but also for the prophylaxis of CAT is the Low Molecular Weight Heparines (LMWHs). Thromboprophylaxis is an important medical decision for cancer patients in daily clinical practice. Methods: This is an observational study conducted by HeSMO in Greek Oncology units, for 1 year, aiming to record CAT management. Patients with active cancer received antithrombotic agents for thromboprophylaxis were enrolled, after signing informed consent. Results: All participating centers reported that approximately 4.300 cancer patients are managed on monthly basis, where the majority (80%) as outpatients. 426 cancer patients enrolled from 18 oncology units with mean age 65.2 years old and mean Body Mass Index (BMI) 26.10. Primary cancers were: lung 25%, pancreas 14%, stomach 8.6%, breast 8.6%, ovarian 7.7%, colorectal 7.5%, bladder 5.6% and other 22.8%. 50% of patients received LMWH at prophylactic doses while the rest received therapeutic doses [mean duration 4.42 months (SD +/- 2.68)]. 126 (30%) patients had Khorana score ≥3. 300 (70%) had Khorana score ≤2 and of these patients 68% were metastatic and 58% were receiving High Thrombotic Chemotherapy Agents (HTCA, e.g. platinum). 16 (3.8%) patients experienced VTE while 9 (56%) of them were incidental. Lower VTE risk [OR: 0.32 (95% CI 0.10, 1.0) p = 0.04] was observed in patients on therapeutic doses LMWH while higher VTE risk [OR: 3.14 (1.01, 9.9)] was observed in patients on prophylactic doses LMWH. High BMI>35 was related to significant higher risk for VTE [OR 5.37 (1.6, 18). Only six (1.4%) grade 1 bleedings were recorded in all patients who receive thromboprophylaxis. Conclusions: CAT is an important problem in oncology. Therapeutic doses of LMWH for thromboprophylaxis are effective and safe. Apart from Khorana score, some other factors such as disease stage and administration of HTCA might be taken into consideration for better CAT risk assessment in oncology patients. Legal entity responsible for the study: Hellenic Society of Medical Oncology (HeSMO), Athens, Greece. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.

Older Adult and Surrogate Perspectives on Serious, Difficult, and Important Medical Decisions.

To elicit decisions that diverse older adults and surrogates perceive as serious, difficult, or important and explore what helped them make those decisions. Focus groups (N=13) in which participants were asked to recall serious, difficult, or important medical decisions and what helped them make those decisions. Clinics, support groups and senior centers. Diverse English- and Spanish-speaking older adults (age: mean 78, range 64-89) and surrogates (age: mean 57, range 33-76) (29% African American, 26% white, 26% Asian or Pacific Islander, 19% Hispanic) (N=69). We used thematic analysis to analyze transcripts. We identified 168 decisions. Older adults from all racial and ethnic groups frequently recalled cancer treatment decisions and decisions about chronic illness management. Surrogates described decisions about transitions in care and medical crises. Older adults valued self-sufficiency and maximizing survival and relied on personal experiences as often as medical advice. In all racial and ethnic groups, surrogates valued avoiding suffering for loved ones. Diverse older adults and surrogates perceive life-threatening illness and day-to-day decisions about chronic disease to be serious, difficult, and important. The surrogates' goal of avoiding suffering of older adults may differ from older adults' priorities of self-sufficiency and maximizing survival. Clinicians should support older adults and surrogates in identifying important and difficult decisions and learn about the values and information sources they bring to decision-making. With this knowledge, clinicians can customize decision support and achieve person-centered care.

Biomaterials for hip implants – important considerations relating to the choice of materials

Abstract This article is a review of important material requirements for hip biomaterials including their response to the body environment (biocompatibility), mechanical properties, wear resistance, fretting corrosion and availability as well as the price. The application of proper biomaterials for hip implants is one of the major focal points in this article. Background information is also provided on metals used in other prosthetic devices and implant components. Titanium and its alloys, cobalt base alloys and stainless steels (bio-steels) are used for load-bearing hip implants. These three groups of metallic materials will be introduced and discussed in detail. Metals and their alloys are crystalline materials since their properties depend on the crystal lattice, chemical and phase compositions, grain size, lattice defects, crystalline texture and residual micro- and macro-stresses. All these features of biomaterials are formed during technological manufacturing, such as metallurgical process, solidification, plastic deformation (rolling and forging), machining, heat treatment and coating. All these technological processes work in optimal conditions in order to achieve the optimal microstructure and mechanical, chemical and biological properties. Amongst the above-mentioned particular properties of biomaterials, fretting is a major concern as regards hip implants at the femoral head and neck taper interface. Additional important mechanisms of interaction between the implant and the human body must be taken into account, i.e. diffusion stream of foreign particles and atoms from the implant to body fluids, to the tissue and to the bone. These foreign particles and atoms are released from the implant to the body fluid, to the tissue and to the bone as wear product during use. All together they contribute to the wear, i.e. loss of weight, strength or volume of hip components. Wear rates of ultrahigh molecular weight polyethylene mated against Ti-6Al-4V are significantly greater than the ones for Co-Cr-Mo alloys. Therefore, thermochemical surface treatments like diffusion ion nitriding should be applied to increase the resistance of titanium alloys to wear. Austenitic stainless steels are also used for temporary applications, but they have lower resistance to pitting corrosion than titanium and cobalt alloys. The purpose of the paper is to introduce a group of metallic materials, which is often chosen for surgical hip implants. Conclusions of the paper refer to information which support important medical and patient decisions on hip implants. Also, the development of biomaterials, their treatments, properties, surface layers and coatings are considered. All these features develop over time and need synergy and experience in the progress of the biomedical, mechanical and materials science.

Assessing precision, bias and sigma-metrics of 53 measurands of the Alinity ci system

Assay performance is dependent on the accuracy and precision of a given method. These attributes can be combined into an analytical Sigma-metric, providing a simple value for laboratorians to use in evaluating a test method's capability to meet its analytical quality requirements. Sigma-metrics were determined for 37 clinical chemistry assays, 13 immunoassays, and 3 ICT methods on the Alinity ci system. MethodsAnalytical Performance Specifications were defined for the assays, following a rationale of using CLIA goals first, then Ricos Desirable goals when CLIA did not regulate the method, and then other sources if the Ricos Desirable goal was unrealistic. A precision study was conducted at Abbott on each assay using the Alinity ci system following the CLSI EP05-A2 protocol. Bias was estimated following the CLSI EP09-A3 protocol using samples with concentrations spanning the assay's measuring interval tested in duplicate on the Alinity ci system and ARCHITECT c8000 and i2000SR systems, where testing was also performed at Abbott. Using the regression model, the %bias was estimated at an important medical decisions point. Then the Sigma-metric was estimated for each assay and was plotted on a method decision chart. The Sigma-metric was calculated using the equation: Sigma-metric=(%TEa−|%bias|)/%CV. ResultsThe Sigma-metrics and Normalized Method Decision charts demonstrate that a majority of the Alinity assays perform at least at five Sigma or higher, at or near critical medical decision levels. ConclusionMore than 90% of the assays performed at Five and Six Sigma. None performed below Three Sigma. Sigma-metrics plotted on Normalized Method Decision charts provide useful evaluations of performance. The majority of Alinity ci system assays had sigma values >5 and thus laboratories can expect excellent or world class performance. Laboratorians can use these tools as aids in choosing high-quality products, further contributing to the delivery of excellent quality healthcare for patients.