Cassandra Siffert, François Romanet, Marion Desmazières, Priscilla Drault, Géraud Gourjon
Objectives: Although cognitive biases are one of the most frequent causes of diagnostic errors, their influence remains underestimated in allied health professions, especially in osteopathy. Yet, a part of osteopathic clinical reasoning and diagnosis rely on the practitioner's intuition and subjective haptic perceptions. The aim of this study is to highlight links between the cognitive biases perceived by the practitioner to understand cognitive patterns during osteopathic diagnosis, and to suggest debiasing strategies.
Methods: A mixed method based on an explanatory sequential type is used. (QUAN→QUAL). A quantitative cross-sectional survey of 272 French osteopaths and three focus groups including 24 osteopaths were carried out. The quantitative analysis includes multinominal logistic regression models and multiple correspondence analysis. The qualitative analysis is based on the framework method (within thematic analysis) and followed a step-by-step guide (Gale et al.).
Results: Among 19 selected biases, osteopaths feel to be affected by 9.4 ± 0.28 biases (range [1-19], median=9). Some presumed biases would be associated, and socio-demographic (gender, age) and professional (experience and types of practice) factors would modify how practitioners perceive the presence of biases. Main debiasing solutions are supervision and transcultural clinical competences.
Conclusions: Osteopaths believe their diagnosis is impaired by the presence of cognitive biases as observed in clinical reality. Some biases are shared with medical doctors, but others are more specific to osteopaths, such as confirmation bias. To reduce their effect, the practitioner needs to be aware of these cognitive patterns of clinical reasoning, understand the patient and himself better, and use objective tests.
{"title":"Cognitive biases in osteopathic diagnosis: a mixed study among French osteopaths.","authors":"Cassandra Siffert, François Romanet, Marion Desmazières, Priscilla Drault, Géraud Gourjon","doi":"10.1515/dx-2024-0144","DOIUrl":"https://doi.org/10.1515/dx-2024-0144","url":null,"abstract":"<p><strong>Objectives: </strong>Although cognitive biases are one of the most frequent causes of diagnostic errors, their influence remains underestimated in allied health professions, especially in osteopathy. Yet, a part of osteopathic clinical reasoning and diagnosis rely on the practitioner's intuition and subjective haptic perceptions. The aim of this study is to highlight links between the cognitive biases perceived by the practitioner to understand cognitive patterns during osteopathic diagnosis, and to suggest debiasing strategies.</p><p><strong>Methods: </strong>A mixed method based on an explanatory sequential type is used. (QUAN→QUAL). A quantitative cross-sectional survey of 272 French osteopaths and three focus groups including 24 osteopaths were carried out. The quantitative analysis includes multinominal logistic regression models and multiple correspondence analysis. The qualitative analysis is based on the framework method (within thematic analysis) and followed a step-by-step guide (Gale et al.).</p><p><strong>Results: </strong>Among 19 selected biases, osteopaths feel to be affected by 9.4 ± 0.28 biases (range [1-19], median=9). Some presumed biases would be associated, and socio-demographic (gender, age) and professional (experience and types of practice) factors would modify how practitioners perceive the presence of biases. Main debiasing solutions are supervision and transcultural clinical competences.</p><p><strong>Conclusions: </strong>Osteopaths believe their diagnosis is impaired by the presence of cognitive biases as observed in clinical reality. Some biases are shared with medical doctors, but others are more specific to osteopaths, such as confirmation bias. To reduce their effect, the practitioner needs to be aware of these cognitive patterns of clinical reasoning, understand the patient and himself better, and use objective tests.</p>","PeriodicalId":11273,"journal":{"name":"Diagnosis","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142946432","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
James G Boyle, Matthew R Walters, Fiona M Burton, Catherine Paton, Martin Hughes, Susan Jamieson, Steven J Durning
Objectives: Diagnostic error is a global emergency. Context specificity is likely a source of the alarming rate of error and refers to the vexing phenomenon whereby a physician can see two patients with the same presenting complaint, identical history and examination findings, but due to the presence of contextual factors, decides on two different diagnoses. Studies have not empirically addressed the potential role of context specificity in management reasoning and errors with a diagnosis may not consistently translate to actual patient care.
Methods: We investigated the effect of context specificity on management reasoning in individuals working within a simulated internal medicine environment. Participants completed two ten minute back to back common encounters. The clinical content of each encounter was identical. One encounter featured the presence of carefully controlled contextual factors (CF+ vs. CF-) designed to distract from the correct diagnosis and management. Immediately after each encounter participants completed a post encounter form.
Results: Twenty senior medical students participated. The leading diagnosis score was higher (mean 0.88; SEM 0.07) for the CF- encounter compared with the CF+ encounter (0.58; 0.1; 95 % CI 0.04-0.56; p=0.02). Management reasoning scores were higher (mean 5.48; SEM 0.66) for the CF- encounter compared with the CF+ encounter (3.5; 0.56; 95 % CI 0.69-3.26; p=0.01). We demonstrated context specificity in both diagnostic and management reasoning.
Conclusions: This study is the first to empirically demonstrate that management reasoning, which directly impacts the patient, is also influenced by context specificity, providing additional evidence of context specificity's role in unwanted variance in health care.
目的:诊断错误是一个全球性的紧急事件。情境特异性可能是错误率令人担忧的一个来源,它指的是一种令人烦恼的现象,即医生可以看到两个具有相同主诉、相同病史和检查结果的患者,但由于情境因素的存在,却做出了两种不同的诊断。研究没有经经验地解决背景特异性在管理推理中的潜在作用,并且诊断错误可能不一致地转化为实际的患者护理。方法:我们研究了情境特异性对在模拟内科环境中工作的个体管理推理的影响。参与者完成了两个10分钟背靠背的共同接触。每次接触的临床内容都是相同的。一次遭遇的特点是存在精心控制的环境因素(CF+ vs. CF-),旨在分散正确的诊断和管理。每次会面后,参与者立即填写一份会面后表格。结果:20名高年级医学生参与。先期诊断评分较高(平均0.88;CF-相遇的SEM为0.07,而CF+相遇的SEM为0.58;0.1;95 % ci 0.04-0.56;p = 0.02)。管理推理得分较高(平均5.48分;CF-遭遇的SEM为0.66),而CF+遭遇的SEM为3.5;0.56;95 % ci 0.69-3.26;p = 0.01)。我们证明了诊断和管理推理的上下文特异性。结论:本研究首次实证证明了直接影响患者的管理推理也受到情境特异性的影响,为情境特异性在医疗保健中不受欢迎的差异中所起的作用提供了额外的证据。
{"title":"On context specificity and management reasoning: moving beyond diagnosis.","authors":"James G Boyle, Matthew R Walters, Fiona M Burton, Catherine Paton, Martin Hughes, Susan Jamieson, Steven J Durning","doi":"10.1515/dx-2024-0122","DOIUrl":"https://doi.org/10.1515/dx-2024-0122","url":null,"abstract":"<p><strong>Objectives: </strong>Diagnostic error is a global emergency. Context specificity is likely a source of the alarming rate of error and refers to the vexing phenomenon whereby a physician can see two patients with the same presenting complaint, identical history and examination findings, but due to the presence of contextual factors, decides on two different diagnoses. Studies have not empirically addressed the potential role of context specificity in management reasoning and errors with a diagnosis may not consistently translate to actual patient care.</p><p><strong>Methods: </strong>We investigated the effect of context specificity on management reasoning in individuals working within a simulated internal medicine environment. Participants completed two ten minute back to back common encounters. The clinical content of each encounter was identical. One encounter featured the presence of carefully controlled contextual factors (CF+ vs. CF-) designed to distract from the correct diagnosis and management. Immediately after each encounter participants completed a post encounter form.</p><p><strong>Results: </strong>Twenty senior medical students participated. The leading diagnosis score was higher (mean 0.88; SEM 0.07) for the CF- encounter compared with the CF+ encounter (0.58; 0.1; 95 % CI 0.04-0.56; p=0.02). Management reasoning scores were higher (mean 5.48; SEM 0.66) for the CF- encounter compared with the CF+ encounter (3.5; 0.56; 95 % CI 0.69-3.26; p=0.01). We demonstrated context specificity in both diagnostic and management reasoning.</p><p><strong>Conclusions: </strong>This study is the first to empirically demonstrate that management reasoning, which directly impacts the patient, is also influenced by context specificity, providing additional evidence of context specificity's role in unwanted variance in health care.</p>","PeriodicalId":11273,"journal":{"name":"Diagnosis","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142946442","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jozsef Kiraly, Andras Berzi, Robert El-Kareh, Eniko Sebestyen, Dora Ujvarosy, Miklos Emri, Harjit Pal Bhattoa, Janos Kappelmayer, Kristen E Miller, Gabor Toth
Objectives: To examine factors impacting diagnostic evaluation of suspected deep vein thrombosis (DVT) by analyzing the test ordering patterns and provider decision-making within a universal health coverage system in Hungary.
Methods: We analyzed test orders for suspected DVT between 2007 and 2020, and the financial framework influencing diagnostic practices. An anonymous survey was also conducted among Emergency Department physicians to explore factors influencing diagnostic decision-making.
Results: A total of 6,821 patients were identified. From 2008 to 2013, the most common diagnostic approach combined D-dimer and duplex ultrasound tests (64.5 %), followed by sole ultrasound (20.5 %) and sole D-dimer (15 %) testing. A marked shift occurred from 2014 onward, with sole ultrasound rising to 88 % of cases by 2018-2020, while combined testing and sole D-dimer orders decreased to 7.9 and 4 %, respectively. In survey results, time efficiency emerged as a key factor for bypassing D-dimer testing, cited by 75 % of physicians. 45 % believed D-dimer costs were comparable to or higher than duplex ultrasound. Financial analysis revealed that the outdated performance points system misrepresented actual costs, resulting in duplex ultrasound being significantly underfunded, which impacts the Radiology Department. This discrepancy contributes to higher national level expenses, driven by the increased reliance on ultrasound.
Conclusions: We found diagnostic practices deviating from international diagnostic guidelines, with an increase in duplex ultrasound over D-dimer. This shift, allowed by an outdated financing structure, increases overall costs for the healthcare system. Revising financial frameworks to reflect true costs is essential for sustainable operations in universal health coverage systems.
{"title":"Breaking the guidelines: how financial unawareness fuels guideline deviations and inefficient DVT diagnostics.","authors":"Jozsef Kiraly, Andras Berzi, Robert El-Kareh, Eniko Sebestyen, Dora Ujvarosy, Miklos Emri, Harjit Pal Bhattoa, Janos Kappelmayer, Kristen E Miller, Gabor Toth","doi":"10.1515/dx-2024-0165","DOIUrl":"https://doi.org/10.1515/dx-2024-0165","url":null,"abstract":"<p><strong>Objectives: </strong>To examine factors impacting diagnostic evaluation of suspected deep vein thrombosis (DVT) by analyzing the test ordering patterns and provider decision-making within a universal health coverage system in Hungary.</p><p><strong>Methods: </strong>We analyzed test orders for suspected DVT between 2007 and 2020, and the financial framework influencing diagnostic practices. An anonymous survey was also conducted among Emergency Department physicians to explore factors influencing diagnostic decision-making.</p><p><strong>Results: </strong>A total of 6,821 patients were identified. From 2008 to 2013, the most common diagnostic approach combined D-dimer and duplex ultrasound tests (64.5 %), followed by sole ultrasound (20.5 %) and sole D-dimer (15 %) testing. A marked shift occurred from 2014 onward, with sole ultrasound rising to 88 % of cases by 2018-2020, while combined testing and sole D-dimer orders decreased to 7.9 and 4 %, respectively. In survey results, time efficiency emerged as a key factor for bypassing D-dimer testing, cited by 75 % of physicians. 45 % believed D-dimer costs were comparable to or higher than duplex ultrasound. Financial analysis revealed that the outdated performance points system misrepresented actual costs, resulting in duplex ultrasound being significantly underfunded, which impacts the Radiology Department. This discrepancy contributes to higher national level expenses, driven by the increased reliance on ultrasound.</p><p><strong>Conclusions: </strong>We found diagnostic practices deviating from international diagnostic guidelines, with an increase in duplex ultrasound over D-dimer. This shift, allowed by an outdated financing structure, increases overall costs for the healthcare system. Revising financial frameworks to reflect true costs is essential for sustainable operations in universal health coverage systems.</p>","PeriodicalId":11273,"journal":{"name":"Diagnosis","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142926591","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Katherine Gavinski, Deborah DiNardo, Scott D Rothenberger, Eliana Bonifacino
Objectives: Published clinical reasoning curricula are limited, and measuring curricular impact has proven difficult. This study aims to evaluate the impact of a broad-reaching, multi-level reasoning curricula by measuring utilization of clinical reasoning terminology in published abstracts.
Methods: In 2014, the University of Pittsburgh Medical Center (UPMC) created a clinical reasoning curriculum with interventions at the student, resident, and faculty levels with the goal of bringing reasoning education to the forefront. This study was a retrospective analysis of published clinical vignettes of the Society of General Internal Medicine prior to local curricular intervention (2014), post-curricular intervention (2018), and on follow-up (2022). UPMC-affiliated abstracts were compared to abstracts containing reasoning terms from all other institutions, at each time point.
Results: There was a statistically significant increase in the use of clinical reasoning terms by UPMC-affiliated participants from 2014 to 2018. Non-UPMC submissions, saw a smaller, but still significant increase in the use of clinical reasoning terms. There was a decline in clinical reasoning term use from 2018 to 2022, both at UPMC and nationally.
Conclusions: This study demonstrates that widespread clinical reasoning curricula can increase interest in and use of clinical reasoning terminology. Further work is needed to develop creative assessment tools for reasoning curricula.
{"title":"Using language to evaluate curricular impact: a novel approach in assessing clinical reasoning curricula.","authors":"Katherine Gavinski, Deborah DiNardo, Scott D Rothenberger, Eliana Bonifacino","doi":"10.1515/dx-2024-0181","DOIUrl":"https://doi.org/10.1515/dx-2024-0181","url":null,"abstract":"<p><strong>Objectives: </strong>Published clinical reasoning curricula are limited, and measuring curricular impact has proven difficult. This study aims to evaluate the impact of a broad-reaching, multi-level reasoning curricula by measuring utilization of clinical reasoning terminology in published abstracts.</p><p><strong>Methods: </strong>In 2014, the University of Pittsburgh Medical Center (UPMC) created a clinical reasoning curriculum with interventions at the student, resident, and faculty levels with the goal of bringing reasoning education to the forefront. This study was a retrospective analysis of published clinical vignettes of the Society of General Internal Medicine prior to local curricular intervention (2014), post-curricular intervention (2018), and on follow-up (2022). UPMC-affiliated abstracts were compared to abstracts containing reasoning terms from all other institutions, at each time point.</p><p><strong>Results: </strong>There was a statistically significant increase in the use of clinical reasoning terms by UPMC-affiliated participants from 2014 to 2018. Non-UPMC submissions, saw a smaller, but still significant increase in the use of clinical reasoning terms. There was a decline in clinical reasoning term use from 2018 to 2022, both at UPMC and nationally.</p><p><strong>Conclusions: </strong>This study demonstrates that widespread clinical reasoning curricula can increase interest in and use of clinical reasoning terminology. Further work is needed to develop creative assessment tools for reasoning curricula.</p>","PeriodicalId":11273,"journal":{"name":"Diagnosis","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142926523","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Cody Clary, Adam Cohen, Shelley Kumar, Moushumi Sur, Brian Rissmiller, Geeta Singhal, Satid Thammasitboon
Objectives: Competency in diagnostic reasoning is integral to medical training and patient safety. Situativity theory highlights the importance of contextual factors on learning and performance, such as being informed of a provisional diagnosis prior to a patient encounter. This study aims to determine how being informed of a provisional diagnosis affects an intern's approach to diagnostic reasoning.
Methods: This mixed methods study was conducted in a real-time workplace learning environment at a large teaching hospital. Interns were randomized to the Chief Complaint (CC) only or chief complaint with Provisional Diagnosis (PD) group. One blinded researcher assessed intern diagnostic reasoning using a validated tool. Mean group scores were compared using the two-sample t-test. The researcher was unblinded for think aloud interviews analyzed via thematic analysis.
Results: There was no difference in performance between the CC and PD groups (mean ± SD): 47.8 ± 8.1 vs. 43.9 ± 10.9, p=0.24. Thematic analysis identified that interns aware of the provisional diagnosis 1) invested less effort in diagnostic reasoning, 2) formulated a differential through a narrowly focused frame, 3) accepted a provisional diagnosis as definitive, and 4) sought to confirm rather than refute the provisional diagnosis.
Conclusions: Our discordant results highlight the complex interplay between a provisional diagnosis and diagnostic reasoning performance in early learners. Though an accurate provisional diagnosis may enhance diagnostic reasoning outcomes, our qualitative results suggest that it may pose certain risks to the diagnostic reasoning process. Metacognitive strategies may be a ripe field for exploration to optimize this complex interplay.
目的:诊断推理能力是医疗培训和患者安全不可或缺的一部分。情境理论强调了情境因素对学习和表现的重要性,例如在遇到病人之前被告知临时诊断。本研究旨在确定被告知临时诊断如何影响实习生的诊断推理方法。方法:在某大型教学医院的实时工作场所学习环境中进行混合方法研究。实习生被随机分为主诉组(CC)和主诉伴临时诊断组(PD)。一名盲法研究人员使用经过验证的工具评估实习生的诊断推理。采用双样本t检验比较各组平均得分。研究人员通过主题分析对“大声思考”访谈进行了分析。结果:CC组与PD组的表现差异无统计学意义(mean±SD): 47.8±8.1 vs 43.9±10.9,p=0.24。专题分析发现,了解临时诊断的实习生1)在诊断推理上投入的精力较少,2)通过狭窄的焦点框架制定差异,3)接受临时诊断作为确定的,4)寻求确认而不是反驳临时诊断。结论:我们不一致的结果突出了早期学习者临时诊断和诊断推理表现之间复杂的相互作用。虽然准确的临时诊断可以增强诊断推理结果,但我们的定性结果表明,它可能对诊断推理过程构成一定的风险。元认知策略可能是探索优化这种复杂相互作用的成熟领域。
{"title":"The effect of a provisional diagnosis on intern diagnostic reasoning: a mixed methods study.","authors":"Cody Clary, Adam Cohen, Shelley Kumar, Moushumi Sur, Brian Rissmiller, Geeta Singhal, Satid Thammasitboon","doi":"10.1515/dx-2024-0097","DOIUrl":"https://doi.org/10.1515/dx-2024-0097","url":null,"abstract":"<p><strong>Objectives: </strong>Competency in diagnostic reasoning is integral to medical training and patient safety. Situativity theory highlights the importance of contextual factors on learning and performance, such as being informed of a provisional diagnosis prior to a patient encounter. This study aims to determine how being informed of a provisional diagnosis affects an intern's approach to diagnostic reasoning.</p><p><strong>Methods: </strong>This mixed methods study was conducted in a real-time workplace learning environment at a large teaching hospital. Interns were randomized to the Chief Complaint (CC) only or chief complaint with Provisional Diagnosis (PD) group. One blinded researcher assessed intern diagnostic reasoning using a validated tool. Mean group scores were compared using the two-sample t-test. The researcher was unblinded for think aloud interviews analyzed via thematic analysis.</p><p><strong>Results: </strong>There was no difference in performance between the CC and PD groups (mean ± SD): 47.8 ± 8.1 vs. 43.9 ± 10.9, p=0.24. Thematic analysis identified that interns aware of the provisional diagnosis 1) invested less effort in diagnostic reasoning, 2) formulated a differential through a narrowly focused frame, 3) accepted a provisional diagnosis as definitive, and 4) sought to confirm rather than refute the provisional diagnosis.</p><p><strong>Conclusions: </strong>Our discordant results highlight the complex interplay between a provisional diagnosis and diagnostic reasoning performance in early learners. Though an accurate provisional diagnosis may enhance diagnostic reasoning outcomes, our qualitative results suggest that it may pose certain risks to the diagnostic reasoning process. Metacognitive strategies may be a ripe field for exploration to optimize this complex interplay.</p>","PeriodicalId":11273,"journal":{"name":"Diagnosis","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142914009","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Denis Horgan, Paul Hofman, Patrizio Giacomini, France Dube, Jaya Singh, Daniel Schneider, Tanya Hills, Jennifer Faikish, Marc Van Den Bulcke, Umberto Malapelle, Maciej Gajewski, Vivek Subbiah
Personalized medicine, aiming to tailor treatments based on individual patient characteristics, holds immense potential in oncology. However, its widespread adoption in Europe faces numerous challenges, as illustrated by the case study of the Oncotype DX Breast Recurrence Score® assay, a genomic test for breast cancer. This manuscript delineates the multifaceted obstacles encountered during the introduction of the Oncotype DX®test (Oncotype DX Breast Recurrence Score test) in Europe from 2004 to 2018. In June 2018, the TAILORx results were published in the New England Journal of Medicine Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF, et al. Adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer. N Engl J Med 2018;379:111-21, Sparano JA, Gray RJ, Ravdin PM, Makower DF, Pritchard KI, Albain KS, et al. Clinical and genomic risk to guide the use of adjuvant therapy for breast cancer. N Engl J Med 2019;380:2395-405, and reported that among 6,711 women with hormone-receptor-positive, HER2-negative, node-negative breast cancer and a midrange recurrence score of 11-25 on the Oncotype DX assay, endocrine therapy was not inferior to chemoendocrine therapy, which provides evidence that adjuvant chemotherapy was not beneficial in these patients. Through a comprehensive analysis of clinical evidence, commercial presence, reimbursement mechanisms, guideline recommendations, regulatory pathways, and local experiences, this study sheds light on the intricate dynamics influencing the adoption of personalized medicine technologies. This article examines the various obstacles encountered during the introduction of the Oncotype DX Breast Cancer Assay in Europe from 2004 to 2018. By analyzing clinical evidence, commercial presence, reimbursement mechanisms, guideline recommendations, regulatory pathways, and local experiences, this study reveals the complex factors that influence the adoption of personalized medicine technologies. By highlighting these challenges, this article offers valuable insights into strategies to facilitate the integration of innovative diagnostic tools into clinical practice across Europe, ultimately leading to improved treatment decision-making for cancer patients.
个性化医疗,旨在根据个体患者的特点定制治疗,在肿瘤学中具有巨大的潜力。然而,它在欧洲的广泛采用面临着许多挑战,正如Oncotype DX乳腺癌复发评分®检测(乳腺癌基因组检测)的案例研究所说明的那样。本文描述了2004年至2018年在欧洲引入Oncotype DX®测试(Oncotype DX乳腺复发评分测试)期间遇到的多方面障碍。2018年6月,TAILORx的研究结果发表在新英格兰医学杂志上,Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF等人。乳腺癌21基因表达测定指导下的辅助化疗。李建军,张建军,李建军,等。中国生物医学工程杂志,2018;39(3):111-21。临床和基因组风险指导乳腺癌辅助治疗的使用。《中华医学杂志》2019;380:2395-405,并报道了6711例激素受体阳性、her2阴性、淋巴结阴性的乳腺癌患者,在Oncotype DX检测中,中期复发评分为11-25分,内分泌治疗并不逊于化疗内分泌治疗,这提供了辅助化疗对这些患者无效的证据。通过对临床证据、商业存在、报销机制、指南建议、监管途径和地方经验的综合分析,本研究揭示了影响个性化医疗技术采用的复杂动态。本文探讨了2004年至2018年在欧洲引入Oncotype DX乳腺癌检测期间遇到的各种障碍。通过分析临床证据、商业存在、报销机制、指南建议、监管途径和地方经验,本研究揭示了影响个性化医疗技术采用的复杂因素。通过强调这些挑战,本文提供了有价值的见解,有助于将创新诊断工具整合到整个欧洲的临床实践中,最终改善癌症患者的治疗决策。
{"title":"Challenges and barriers for the adoption of personalized medicine in Europe: the case of Oncotype DX Breast Recurrence Score<sup>®</sup> test.","authors":"Denis Horgan, Paul Hofman, Patrizio Giacomini, France Dube, Jaya Singh, Daniel Schneider, Tanya Hills, Jennifer Faikish, Marc Van Den Bulcke, Umberto Malapelle, Maciej Gajewski, Vivek Subbiah","doi":"10.1515/dx-2024-0127","DOIUrl":"https://doi.org/10.1515/dx-2024-0127","url":null,"abstract":"<p><p>Personalized medicine, aiming to tailor treatments based on individual patient characteristics, holds immense potential in oncology. However, its widespread adoption in Europe faces numerous challenges, as illustrated by the case study of the Oncotype DX Breast Recurrence Score<sup>®</sup> assay, a genomic test for breast cancer. This manuscript delineates the multifaceted obstacles encountered during the introduction of the Oncotype DX<sup>®</sup>test (Oncotype DX Breast Recurrence Score test) in Europe from 2004 to 2018. In June 2018, the TAILORx results were published in the New England Journal of Medicine Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF, et al. Adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer. N Engl J Med 2018;379:111-21, Sparano JA, Gray RJ, Ravdin PM, Makower DF, Pritchard KI, Albain KS, et al. Clinical and genomic risk to guide the use of adjuvant therapy for breast cancer. N Engl J Med 2019;380:2395-405, and reported that among 6,711 women with hormone-receptor-positive, HER2-negative, node-negative breast cancer and a midrange recurrence score of 11-25 on the Oncotype DX assay, endocrine therapy was not inferior to chemoendocrine therapy, which provides evidence that adjuvant chemotherapy was not beneficial in these patients. Through a comprehensive analysis of clinical evidence, commercial presence, reimbursement mechanisms, guideline recommendations, regulatory pathways, and local experiences, this study sheds light on the intricate dynamics influencing the adoption of personalized medicine technologies. This article examines the various obstacles encountered during the introduction of the Oncotype DX Breast Cancer Assay in Europe from 2004 to 2018. By analyzing clinical evidence, commercial presence, reimbursement mechanisms, guideline recommendations, regulatory pathways, and local experiences, this study reveals the complex factors that influence the adoption of personalized medicine technologies. By highlighting these challenges, this article offers valuable insights into strategies to facilitate the integration of innovative diagnostic tools into clinical practice across Europe, ultimately leading to improved treatment decision-making for cancer patients.</p>","PeriodicalId":11273,"journal":{"name":"Diagnosis","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142834578","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objectives: Validation and performance assessment of novel ESR analyzer is required before implementation. The objective of this study was to assess the correlation between three ESR measurement methods. Full validation and performance assessment of an alternate method (TEST1) were also evaluated.
Methods: Three-way correlation assessment for the Westergren (WG), modified Westregren (Mixrate), and alternate (TEST1) methods were performed. Analytical performance of TEST1 including precision, carryover, sample stability, potential interferences as well as effect of hematocrit (Hct) and mean corpuscular volume (MCV) were also determined.
Results: Strong correlation between three ESR measurement methods were observed. Correlation coefficient (r) was 0.902, 0.977, and 0.949 for WG vs. TEST1, WG vs. Mixrate, and TEST1 vs. Mixrate, respectively with absolute bias <5 mm. For TEST1, precision and carryover were within the manufacturer's claim. Samples were stable upto 24 h and 48 h when they were stored at room temperature or 2-8 °C, respectively. No effect of trigyceride and cholesterol was observed. In low Hct samples, no significant different between the results obtained from Fabry's formula corrected WG values and from TEST1.
Conclusions: Three-way comparison study yielded a strong correlation between methods. As part of the method validation before implementing a new analyzer, full validation of TEST1 showed that all validated parameters met the manufacturer's specifications. A negative bias was observed but remains within the acceptable criteria. Difference in values for samples with low hematocrit were noted, but these can be corrected by Fabry's formula applied to the values from WG method.
{"title":"Three-way comparison of different ESR measurement methods and analytical performance assessment of TEST1 automated ESR analyzer.","authors":"Kwanlada Chaiwong, Rujira Naksith, Waroonkarn Laiklang, Manissara Yeekaday, Suppakorn Wongkamchai, Orakan Limpornpukdee, Chutitorn Ketloy, Eakachai Prompetchara","doi":"10.1515/dx-2024-0158","DOIUrl":"https://doi.org/10.1515/dx-2024-0158","url":null,"abstract":"<p><strong>Objectives: </strong>Validation and performance assessment of novel ESR analyzer is required before implementation. The objective of this study was to assess the correlation between three ESR measurement methods. Full validation and performance assessment of an alternate method (TEST1) were also evaluated.</p><p><strong>Methods: </strong>Three-way correlation assessment for the Westergren (WG), modified Westregren (Mixrate), and alternate (TEST1) methods were performed. Analytical performance of TEST1 including precision, carryover, sample stability, potential interferences as well as effect of hematocrit (Hct) and mean corpuscular volume (MCV) were also determined.</p><p><strong>Results: </strong>Strong correlation between three ESR measurement methods were observed. Correlation coefficient (r) was 0.902, 0.977, and 0.949 for WG vs. TEST1, WG vs. Mixrate, and TEST1 vs. Mixrate, respectively with absolute bias <5 mm. For TEST1, precision and carryover were within the manufacturer's claim. Samples were stable upto 24 h and 48 h when they were stored at room temperature or 2-8 °C, respectively. No effect of trigyceride and cholesterol was observed. In low Hct samples, no significant different between the results obtained from Fabry's formula corrected WG values and from TEST1.</p><p><strong>Conclusions: </strong>Three-way comparison study yielded a strong correlation between methods. As part of the method validation before implementing a new analyzer, full validation of TEST1 showed that all validated parameters met the manufacturer's specifications. A negative bias was observed but remains within the acceptable criteria. Difference in values for samples with low hematocrit were noted, but these can be corrected by Fabry's formula applied to the values from WG method.</p>","PeriodicalId":11273,"journal":{"name":"Diagnosis","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142812334","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jonathan G Sawicki, Jessica Graham, Gitte Larsen, Jennifer K Workman
Objectives: To identify clinical presentations that acted as harbingers for future sepsis hospitalizations in pediatric patients evaluated in the emergency department (ED) using the Symptom Disease Pair Analysis of Diagnostic Error (SPADE) methodology.
Methods: We identified patients in the Pediatric Health Information Systems (PHIS) database admitted for sepsis between January 1, 2004 and December 31, 2023 and limited the study cohort to those patients who had an ED treat-and-release visit in the 30 days prior to admission. Using the look-back approach of the SPADE methodology, we identified the most common clinical presentations at the initial ED visit and used an observed to expected (O:E) analysis to determine which presentations were overrepresented. We then employed a graphical, temporal analysis with a comparison group to identify which overrepresented presentations most likely represented harbingers for future sepsis hospitalization.
Results: We identified 184,157 inpatient admissions for sepsis, of which 15,331 hospitalizations (8.3 %) were preceded by a treat-and-release ED visit in the prior 30 days. Based on the O:E and temporal analyses, the presentations of fever and dehydration were both overrepresented in the study cohort and temporally clustered close to sepsis hospitalization. ED treat-and-release visits for fever or dehydration preceded 1.2 % of all sepsis admissions.
Conclusions: In pediatric patients presenting to the ED, fever and dehydration may represent harbingers for future sepsis hospitalization. The SPADE methodology could be applied to the PHIS database to develop diagnostic performance measures across a wide range of pediatric hospitals.
{"title":"Harbingers of sepsis misdiagnosis among pediatric emergency department patients.","authors":"Jonathan G Sawicki, Jessica Graham, Gitte Larsen, Jennifer K Workman","doi":"10.1515/dx-2024-0119","DOIUrl":"https://doi.org/10.1515/dx-2024-0119","url":null,"abstract":"<p><strong>Objectives: </strong>To identify clinical presentations that acted as harbingers for future sepsis hospitalizations in pediatric patients evaluated in the emergency department (ED) using the Symptom Disease Pair Analysis of Diagnostic Error (SPADE) methodology.</p><p><strong>Methods: </strong>We identified patients in the Pediatric Health Information Systems (PHIS) database admitted for sepsis between January 1, 2004 and December 31, 2023 and limited the study cohort to those patients who had an ED treat-and-release visit in the 30 days prior to admission. Using the look-back approach of the SPADE methodology, we identified the most common clinical presentations at the initial ED visit and used an observed to expected (O:E) analysis to determine which presentations were overrepresented. We then employed a graphical, temporal analysis with a comparison group to identify which overrepresented presentations most likely represented harbingers for future sepsis hospitalization.</p><p><strong>Results: </strong>We identified 184,157 inpatient admissions for sepsis, of which 15,331 hospitalizations (8.3 %) were preceded by a treat-and-release ED visit in the prior 30 days. Based on the O:E and temporal analyses, the presentations of fever and dehydration were both overrepresented in the study cohort and temporally clustered close to sepsis hospitalization. ED treat-and-release visits for fever or dehydration preceded 1.2 % of all sepsis admissions.</p><p><strong>Conclusions: </strong>In pediatric patients presenting to the ED, fever and dehydration may represent harbingers for future sepsis hospitalization. The SPADE methodology could be applied to the PHIS database to develop diagnostic performance measures across a wide range of pediatric hospitals.</p>","PeriodicalId":11273,"journal":{"name":"Diagnosis","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142812320","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}