scholarly journals Post-analytical laboratory work: national recommendations from the Working Group for Post-analytics on behalf of the Croatian Society of Medical Biochemistry and Laboratory Medicine

2019 ◽  
Vol 29 (2) ◽  
pp. 228-261 ◽  
Author(s):  
Jasna Lenicek Krleza ◽  
Lorena Honovic ◽  
Jelena Vlasic Tanaskovic ◽  
Sonja Podolar ◽  
Vladimira Rimac ◽  
...  
Keyword(s):  
Best Practices ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Test Results ◽  
Final Phase ◽  
Timely Manner ◽  
Guidelines Implementation ◽  
Laboratory Test Results ◽  
Analytical Phase ◽  
Total Testing Process

The post-analytical phase is the final phase of the total testing process and involves evaluation of laboratory test results; release of test results in a timely manner to appropriate individuals, particularly critical results; and modification, annotation or revocation of results as necessary to support clinical decision-making. Here we present a series of recommendations for post-analytical best practices, tailored to medical biochemistry laboratories in Croatia, which are intended to ensure alignment with national and international norms and guidelines. Implementation of the national recommendations is illustrated through several examples.

High-resolution pediatric reference intervals for 15 biochemical analytes described using fractional polynomials

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Jakob Zierk ◽  
Hannsjörg Baum ◽  
Alexander Bertram ◽  
Martin Boeker ◽  
Armin Buchwald ◽  
...  
Keyword(s):  
Information Systems ◽  
Laboratory Test ◽  
Clinical Decision Making ◽  
Age Groups ◽  
Clinical Decision ◽  
Reference Intervals ◽  
Test Results ◽  
Laboratory Test Results ◽  
Glutamyl Transferase ◽  
Laboratory Information Systems

Abstract Objectives Assessment of children’s laboratory test results requires consideration of the extensive changes that occur during physiological development and result in pronounced sex- and age-specific dynamics in many biochemical analytes. Pediatric reference intervals have to account for these dynamics, but ethical and practical challenges limit the availability of appropriate pediatric reference intervals that cover children from birth to adulthood. We have therefore initiated the multi-center data-driven PEDREF project (Next-Generation Pediatric Reference Intervals) to create pediatric reference intervals using data from laboratory information systems. Methods We analyzed laboratory test results from 638,683 patients (217,883–982,548 samples per analyte, a median of 603,745 test results per analyte, and 10,298,067 test results in total) performed during patient care in 13 German centers. Test results from children with repeat measurements were discarded, and we estimated the distribution of physiological test results using a validated statistical approach (kosmic). Results We report continuous pediatric reference intervals and percentile charts for alanine transaminase, aspartate transaminase, lactate dehydrogenase, alkaline phosphatase, γ-glutamyl-transferase, total protein, albumin, creatinine, urea, sodium, potassium, calcium, chloride, anorganic phosphate, and magnesium. Reference intervals are provided as tables and fractional polynomial functions (i.e., mathematical equations) that can be integrated into laboratory information systems. Additionally, Z-scores and percentiles enable the normalization of test results by age and sex to facilitate their interpretation across age groups. Conclusions The provided reference intervals and percentile charts enable precise assessment of laboratory test results in children from birth to adulthood. Our findings highlight the pronounced dynamics in many biochemical analytes in neonates, which require particular consideration in reference intervals to support clinical decision making most effectively.

Roles of Trust and Cross-Cultural Miscommunication in Clinical Decision-Making

2003 ◽  
Vol 1 (2) ◽  
pp. 198-207
Author(s):  
H. Mabel Preloran ◽  
Silvia Balzano
Keyword(s):  
Medical Education ◽  
Los Angeles ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Severe Disabilities ◽  
Cross Cultural ◽  
Emotional Engagement ◽  
Test Results ◽  
Clinical Protocol ◽  
Emotional Detachment

This paper explores the emotional world of a recent Mexican immigrant who lives in Los Angeles and is awaiting the results of the amniocentesis she has ambivalently agreed to. She is 45 years old and has given birth to two children with severe disabilities and two who are apparently normal. We focus our analysis on the woman's reactions and feelings during the nine days she spends waiting for the test results. We show that the standard prenatal genetic clinical protocol aimed at providing medical education and requiring professional neutrality and emotional detachment left the woman feeling rejected and subsequently unwilling to seek information or support from her clinicians. We find that while the intent of a protocol of neutrality is to enable patients to make informed decisions without feeling pressure from clinicians, some women want greater emotional engagement. We argue that professional neutrality can inhibit patient-clinician communication, hamper medical education, and ultimately detract from patients' ability to make informed medical choices. / El presente artículo explora el mundo emocional de Rocío, una inmigrante mexicana, quien se encuentra esperando los resultados de una amniocentesis que aceptó hacerse, a pesar de las dudas sobre la credibilidad y utilidad de la misma. Rocío, de 45 años, tenía ya otros hijos, dos con anormalidades severas y dos aparentemente sanos. Centramos nuestro análisis en los sentimientos y reacciones durante los nueve días que transcurren mientras espera el diagnóstico. En este trabajo mostramos cómo la forma de presentar la información médica puede llegar a entorpecer la toma de decisión de un paciente. El protocolo genético tiene por meta proveer información médica manteniendo una cierta distancia profesional y emocional. Estas condiciones hacen que, en nuestro estudio de caso, la paciente se sienta rechazada y sin deseos de acercarse al personal médico, ya sea en busca de apoyo emocional o información que aclararía sus dudas. Creemos que, mientras el objetivo de la neutralidad profesional es asegurar que el paciente decida con los conocimientos adecuados y, a la vez, sin sentirse presionado, algunas mujeres preferirían un mayor acercamiento emocional por parte del personal médico cuando deben decidir sobre pruebas o tratamientos. Creemos que la neutralidad profesional puede llegar a inhibir la comunicación médico-paciente, dificultar la comprensión de la información y, por último, obstaculizar la habilidad de tomar decisiones informadas por parte de los pacientes.

Pediatric reference interval verification for endocrine and fertility hormone assays on the Abbott Alinity system

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Mary Kathryn Bohn ◽  
Siobhan Wilson ◽  
Alexandra Hall ◽  
Khosrow Adeli
Keyword(s):  
Clinical Decision Making ◽  
De Novo ◽  
Reference Interval ◽  
Clinical Decision ◽  
Reference Intervals ◽  
Healthy Children ◽  
Confidence Limits ◽  
Test Results ◽  
Serum Samples ◽  
Abbott Architect

Abstract Objectives The Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) has developed an extensive database of reference intervals (RIs) for several biomarkers on various analytical systems. In this study, pediatric RIs were verified for key immunoassays on the Abbott Alinity system based on the analysis of healthy children samples and comparison to comprehensive RIs previously established for Abbott ARCHITECT assays. Methods Analytical performance of Alinity immunoassays was first assessed. Subsequently, 100 serum samples from healthy children recruited with informed consent were analyzed for 16 Alinity immunoassays. The percentage of test results falling within published CALIPER ARCHITECT reference and confidence limits was determined. If ≥ 90% of test results fell within the confidence limits, they were considered verified based on CLSI guidelines. If <90% of test results fell within the confidence limits, additional samples were analyzed and new Alinity RIs were established. Results Of the 16 immunoassays assessed, 13 met the criteria for verification with test results from ≥ 90% of healthy serum samples falling within the published ARCHITECT confidence limits. New CALIPER RIs were established for free thyroxine and prolactin on the Alinity system. Estradiol required special considerations in early life. Conclusions Our data demonstrate excellent concordance between ARCHITECT and Alinity immunoassays, as well as the robustness of previously established CALIPER RIs for most immunoassays, eliminating the need for de novo RI studies for most parameters. Availability of pediatric RIs for immunoassays on the Alinity system will assist clinical laboratories using this new platform and contribute to improved clinical decision-making.

scholarly journals Gaitography on lower-limb amputees: Repeatability and between-methods agreement

2018 ◽  
Vol 43 (1) ◽  
pp. 71-79 ◽  
Author(s):  
Celine Timmermans ◽  
Andrea G. Cutti ◽  
Hester van Donkersgoed ◽  
Melvyn Roerdink
Keyword(s):  
Clinical Decision Making ◽  
Center Of Pressure ◽  
Clinical Decision ◽  
Repeated Measurements ◽  
Test Results ◽  
Foot Placement ◽  
Gait Characteristics ◽  
Gait Parameters ◽  
Two Samples ◽  
Systematic Biases

Background: Gaitography is gait parametrization from center-of-pressure trajectories of walking on an instrumented treadmill. Gaitograms may be useful for prosthetic gait analyses, as they can be rapidly and unobtrusively collected over multiple gait cycles without constraining foot placement. However, its reliability must still be established for prosthetic gait. Objectives: To evaluate (a) within-method test–retest repeatability and (b) between-methods agreement for temporal gait events (foot contact, foot off) and gait characteristics (e.g. step times, single-support duration). Study design: Cohort study with repeated measurements. Methods: Ten male proficient prosthetic walkers with a unilateral trans-femoral or trans-tibial amputation were equipped with a pressure-insole system and were invited to walk on separate days on an instrumented treadmill. Results: We found better between-methods reproducibility than within-method repeatability in temporal gait characteristics. Step times, stride times, and foot-contact events matched well between the two methods. In contrast, insole-based foot-off events were detected one-to-two samples earlier. Likewise, a similar bias was observed for temporal gait characteristics that incorporated foot-off events. Conclusion: Notwithstanding small systematic biases, the good between-methods agreement indicates that temporal gait characteristics may be determined interchangeably with gaitograms and insoles in persons with a prosthesis. However, the relatively poorer test–retest repeatability hinders longitudinal assessments with either method. Clinical relevance: Clinical practice could potentially benefit from gaitography as an efficient, unobtrusive, easy to use, automatized, and patient-friendly means to objectively parametrize prosthetic gait, with immediate availability of test results allowing for prompt clinical decision-making. Temporal gait parameters demonstrate good between-methods agreement, but poorer within-method repeatability hinders detecting prosthetic gait changes.

scholarly journals Data mining of pediatric reference intervals

2021 ◽  
Vol 45 (6) ◽  
pp. 311-317
Author(s):  
Jakob Zierk ◽  
Markus Metzler ◽  
Manfred Rauh
Keyword(s):  
Data Mining ◽  
Information Systems ◽  
Statistical Methods ◽  
Clinical Decision Making ◽  
Reference Intervals ◽  
Healthy Children ◽  
Test Results ◽  
Young Infants ◽  
Age Related ◽  
Laboratory Test Results

Abstract Laboratory tests are essential to assess the health status and to guide patient care in individuals of all ages. The interpretation of quantitative test results requires availability of appropriate reference intervals, and reference intervals in children have to account for the extensive physiological dynamics with age in many biomarkers. Creation of reference intervals using conventional approaches requires the sampling of healthy individuals, which is opposed by ethical and practical considerations in children, due to the need for a large number of blood samples from healthy children of all ages, including neonates and young infants. This limits the availability and quality of pediatric reference intervals, and ultimately negatively impacts pediatric clinical decision-making. Data mining approaches use laboratory test results and clinical information from hospital information systems to create reference intervals. The extensive number of available test results from laboratory information systems and advanced statistical methods enable the creation of pediatric reference intervals with an unprecedented age-related accuracy for children of all ages. Ongoing developments regarding the availability and standardization of electronic medical records and of indirect statistical methods will further improve the benefit of data mining for pediatric reference intervals.

scholarly journals Roles of Trust and Cross-Cultural Miscommunication in Clinical Decision-Making

2003 ◽  
Vol 1 (2) ◽  
pp. 198-207
Author(s):  
H. Mabel Preloran ◽  
Silvia Balzano
Keyword(s):  
Medical Education ◽  
Los Angeles ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Severe Disabilities ◽  
Cross Cultural ◽  
Emotional Engagement ◽  
Test Results ◽  
Clinical Protocol ◽  
Emotional Detachment

This paper explores the emotional world of a recent Mexican immigrant who lives in Los Angeles and is awaiting the results of the amniocentesis she has ambivalently agreed to. She is 45 years old and has given birth to two children with severe disabilities and two who are apparently normal. We focus our analysis on the woman's reactions and feelings during the nine days she spends waiting for the test results. We show that the standard prenatal genetic clinical protocol aimed at providing medical education and requiring professional neutrality and emotional detachment left the woman feeling rejected and subsequently unwilling to seek information or support from her clinicians. We find that while the intent of a protocol of neutrality is to enable patients to make informed decisions without feeling pressure from clinicians, some women want greater emotional engagement. We argue that professional neutrality can inhibit patient-clinician communication, hamper medical education, and ultimately detract from patients' ability to make informed medical choices. / El presente artículo explora el mundo emocional de Rocío, una inmigrante mexicana, quien se encuentra esperando los resultados de una amniocentesis que aceptó hacerse, a pesar de las dudas sobre la credibilidad y utilidad de la misma. Rocío, de 45 años, tenía ya otros hijos, dos con anormalidades severas y dos aparentemente sanos. Centramos nuestro análisis en los sentimientos y reacciones durante los nueve días que transcurren mientras espera el diagnóstico. En este trabajo mostramos cómo la forma de presentar la información médica puede llegar a entorpecer la toma de decisión de un paciente. El protocolo genético tiene por meta proveer información médica manteniendo una cierta distancia profesional y emocional. Estas condiciones hacen que, en nuestro estudio de caso, la paciente se sienta rechazada y sin deseos de acercarse al personal médico, ya sea en busca de apoyo emocional o información que aclararía sus dudas. Creemos que, mientras el objetivo de la neutralidad profesional es asegurar que el paciente decida con los conocimientos adecuados y, a la vez, sin sentirse presionado, algunas mujeres preferirían un mayor acercamiento emocional por parte del personal médico cuando deben decidir sobre pruebas o tratamientos. Creemos que la neutralidad profesional puede llegar a inhibir la comunicación médico-paciente, dificultar la comprensión de la información y, por último, obstaculizar la habilidad de tomar decisiones informadas por parte de los pacientes.

scholarly journals Genomic screening and genomic diagnostic testing—two very different kettles of fish

2019 ◽  
Vol 11 (1) ◽  
Author(s):  
Leslie G. Biesecker
Keyword(s):  
Decision Making ◽  
Clinical Decision Making ◽  
Diagnostic Testing ◽  
Clinical Decision ◽  
Bayes Theorem ◽  
Genomic Testing ◽  
Test Results ◽  
Correct Interpretation ◽  
Genomic Test ◽  
Genomic Screening

AbstractGenomic testing can be misunderstood as being determinative, when in reality it is the same as all other tests and context is essential for its correct interpretation. Two hypothetical cases of testing for Marfan syndrome demonstrate how clinicians should contextualize genomic test results and the implementation of Bayes theorem in clinical decision-making.

Integration of germline multigene panel testing into breast and gynecologic oncology clinics.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 164-164
Author(s):  
Mariella Tejada ◽  
June YiJuan Hou ◽  
Katherine D. Crew ◽  
Melissa Kate Accordino ◽  
Kevin Kalinsky ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Decision Making ◽  
Genetic Testing ◽  
Clinical Decision Making ◽  
Genetic Test ◽  
Gynecologic Oncology ◽  
Clinical Decision ◽  
Test Results ◽  
Panel Testing ◽  
Genetic Test Results

164 Background: Germline genetic testing plays an important role in informing cancer screening and risk-reducing strategies, as well as treatment decisions with PARP inhibitors for BRCA-associated malignancies. Referrals to clinical genetics for pre-test counseling and results disclosure can be delayed due to financial and logistical barriers, which may ultimately delay clinical decision-making. Our study objective was to understand patient attitudes, knowledge, and anxiety/distress with point-of-care (POC) genetic testing in breast and gynecologic oncology clinics. Methods: We enrolled patients with early-stage breast cancer undergoing neoadjuvant treatment, metastatic breast cancer, ovarian cancer, or endometrial cancer undergoing POC multigene panel testing with their primary oncologist, rather than a genetic counselor. Pre-test counseling came from discussion with their primary oncologist. Participants completed a survey at time of genetic testing and one after return of genetic test results. Validated measures of genetic testing knowledge, cancer-related distress, and attitudes towards genetic testing were included. Descriptive statistics were generated for all data collected and paired t-tests were conducted for baseline and follow-up comparisons. Results: We enrolled 106 subjects, of which 97 completed the baseline survey. All participants were female with a mean age of 61.5 years (SD 13.5). The cohort consisted of participants with the following tumor types: 80 breast, 2 ovarian, and 16 endometrial. Almost 44% of women identified as Hispanic/Latina, 55% had highest level of education of community/technical college or less, and 51.2% reported annual incomes of less than $50,000. Forty-seven percent of participants had adequate baseline genetic testing knowledge scores (defined as at least 50% correct responses). A majority of participants (86.6%) had positive attitudes toward undergoing genetic testing. Results of genetic testing revealed 11 participants (11.3%) with pathogenic or likely pathogenic variants (of which 36.3% were in BRCA1/2), 25 (25.8%) with variants of unknown significance (VUS), and 61 (62.9%) with benign or likely benign results. The mean cancer-related distress score (scale from 15 to 60, higher score indicates higher levels of distress) was 32.78 (SD 9.74) at baseline and 26.5 (SD 8.9) after receiving genetic testing results (p = 0.002). Genetic test results informed cancer treatment decisions regarding medications and surgery in 15% and 13% of patients, respectively, the majority of which were breast cancer patients. Conclusions: As genetic testing is more frequently used for clinical decision-making it is important to develop ways to efficiently integrate POC testing in the oncology clinics. We demonstrated that POC genetic testing for breast and gynecologic cancers is feasible and can inform clinical decision-making.

Clinical Epidemiology

2016 ◽  
pp. 285-290
Author(s):  
Scott C. Litin ◽  
John B. Bundrick
Keyword(s):  
Diagnostic Test ◽  
Diagnostic Tests ◽  
Clinical Decision Making ◽  
Clinical Epidemiology ◽  
Clinical Decision ◽  
Test Results ◽  
Specific Patient ◽  
Predictive Values ◽  
Test Sensitivity ◽  
Sensitivity Specificity

Diagnostic tests are tools that either increase or decrease the likelihood of disease. The sensitivity, specificity, and predictive values of normal and abnormal test results can be calculated with even a limited amount of information. Some physicians prefer interpreting diagnostic test results by using the likelihood ratio. This ratio takes properties of a diagnostic test (sensitivity and specificity) and makes them more helpful in clinical decision making. It helps the clinician determine the probability of disease in a specific patient after a diagnostic test has been performed.

scholarly journals Dedicated Education Unit: Improving graduating nursing students’ preparedness for practice

2020 ◽  
Vol 11 (1) ◽  
pp. 59
Author(s):  
Persephone Vargas ◽  
Kimberly Dimino ◽  
Spencer Mullen
Keyword(s):  
Decision Making ◽  
Nursing Students ◽  
Test Scores ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Test Results ◽  
Dedicated Education Unit ◽  
Self Confidence ◽  
Post Test ◽  
Readiness For Practice

Background and Objective: Majority of new graduate nurses are not adequately prepared to assume the dynamic and complex role of today’s professional nurse. The Dedicated Education Unit (DEU) is a clinical teaching model developed in response to the limitations of traditional clinical model (TCM). The aim of the study is to examine the readiness for practice and level of confidence in clinical decision making among graduating nursing students in the DEU and compare it with the students in the TCM.Methods: A pre-test/post-test design was used.  The Casey-Fink Readiness for Practice was utilized in the pre and post-test surveys and the Nursing Anxiety and Self-Confidence in Clinical Decision-Making was used in the post test. Data were analyzed in aggregate and pre-test scores were compared to post-test scores at the cohort level using t-test.Results: The pre-test results showed no significant difference between the DEU and TCM groups. However, the post-test results showed higher levels of readiness for practice and higher self-confidence and lower anxiety in clinical decision making among the DEU students.Conclusions: The study provides evidence on the impact of the DEU in providing graduating nursing students with high quality clinical education to better prepare them for practice.

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