Computerized Screening Devices and Performance Assessment: Development of a Policy Towards Automation
The extension of automation to the diagnostic assessment of clinical materials raises issues of professional responsibility, on the part of both the medical professional and designer of the device. The International Academy of Cytology (IAC) and other professional cytology societies should develop a policy towards automation in the diagnostic assessment of clinical cytologic materials. The following summarizes the discussion of the initial position statement at the International Expert Conference on Diagnostic Cytology Towards the 21st Century, Hawaii, June 1997. 1. The professional in charge of a clinical cytopathology laboratory continues to bear the ultimate medical responsibility for diagnostic decisions made at the facility, whether automated devices are involved or not. 2. The introduction of automated procedures into clinical cytology should under no circumstances lead to a lowering of standards of performance. A prime objective of any guidelines should be to ensure that an automated procedure, in principle, does not expose any patient to new risks, nor should it increase already-existing, inherent risks. 3. Automated devices should provide capabilities for the medical professional to conduct periodic tests of the appropriate performance of the device. 4. Supervisory personnel should continue visual quality control screening of a certain percentage of slides dismissed at primary screening as within normal limits (WNL), even when automated procedures are employed in the laboratory. 5. Specifications for the design of primary screening devices for the detection of cervical cancer issued by the IAC in 1984 were reaffirmed. 6. The setting of numeric performance criteria is the proper charge of regulatory agencies, which also have the power of enforcement. 7. Human expert verification of results represents the "gold standard" at this time. Performance characteristics of computerized cytology devices should be determined by adherence to defined and well-considered protocols. Manufacturers should not claim a new standard of care; this is the responsibility of the medical community and professional groups. 8. Cytology professionals should support the development of procedures that bring about an improvement in diagnostic decision making. Advances in technology should be adopted if they can help solve problems in clinical cytology. The introduction of automated procedures into diagnostic decision making should take place strictly under the supervision and with the active participation and critical evaluation by the professional cytology community. Guidelines should be developed for the communication of technical information about the performance of automated screening devices by the IAC to governmental agencies and national societies. Also, guidelines are necessary for the official communication of IAC concerns to industry, medicolegal entities and the media. Procedures and guidelines for the evaluation of studies pertaining to the performance of automated devices, performance metrics and definitions for evaluation criteria should be established.
- Research Article
- 10.1002/cncy.21732
- Jun 1, 2016
- Cancer Cytopathology
It is with mixed emotions that I say goodbye to our Associate Editor, Gladwyn Leiman, MBBCh, FIAC, FRCPath, professor and director of cytopathology and the Cytopathology Fellowship Program at the University of Vermont College of Medicine in Burlington, who is retiring from practice this year. We will miss her very much at Cancer Cytopathology. Gladwyn joined Cancer Cytopathology as an editorial board member in 2001 and was appointed Associate Editor in 2011. She has been a wellspring of ideas and vision and an amazing colleague. Those of us fortunate enough to have worked with her during her tenure as a cytopathologist have experienced firsthand her enthusiasm and dedication to our specialty. Gladwyn's distinguished career began in Johannesburg, South Africa. After her medical and postgraduate training at the University of Witwatersrand Medical School, she was appointed medical officer and subsequently an associate professor in the Cytology Unit in the Department of Anatomical Pathology in the School of Pathology of the South African Institute for Medical Research. A large part of her academic life was spent as an educator both at home and internationally, bringing cytology workshops, tutorials, and seminars to 5 continents. She was quickly recognized as a leader in this evolving field, and over the next 30 years she brought her knowledge, insight, and collegiality to numerous international committees such as the International Academy of Cytology, the American Society of Cytopathology, the Papanicolaou Society of Cytopathology, the International Academy of Pathology, the British Society for Clinical Cytology, and the International Congress of Cytology. Within cytopathology, Gladwyn was actively involved as an Associate Editor for Acta Cytologica and served on several editorial boards, including those for Diagnostic Cytopathology and Advances in Anatomic Pathology. Notably, in 1996, she was named as a Light Source Personality of Cytopathology in South Africa by the International Academy of Cytology “CYTOPATHS” newsletter. And in 1999, the refurbished laboratory at the South African Institute for Medical Research was renamed the Gladwyn Leiman Cytopathology Centre. At the beginning of the new millennium, Gladwyn traveled to the United States as a professor of pathology to assume the directorships of the Laboratory and Fellowship Program at the University of Vermont College of Medicine in Burlington. She continued to expand her affiliations to include the United States and Canadian Academy of Pathology, the International Society of Breast Pathology, and the Australian Society of Cytology, all the while retaining her dedication to cytopathology in South Africa. During the International Congress of Cytology in Paris in 2013, Gladwyn received the 2012 Maurice Goldblatt Award. An excerpt from this recognition epitomizes Gladwyn: “For her lifelong love and dedication to clinical cytology; for her very special relationship to underserved areas of the world and her willingness to bring knowledge and expertise to people deserving improved medical care; for her academic rigor and achievements in publishing and teaching; to her loyal support of Acta Cytologica and the International Academy of Cytology for many years.” Gladwyn's accomplishments cannot be summarized in this short editorial. It suffices to say that she has had a measurable impact on the evolution of our discipline. In this issue, Gladwyn authors one of Cancer Cytopathology's 20th anniversary editorials reflecting on the seminal articles and changes in the field of pulmonary cytopathology. One reason for the success of Cancer Cytopathology is the effort exhibited by our Associate Editors in the selection and critical review of articles received for publication. Undoubtedly, we have benefited immensely from Gladwyn's wisdom and expertise in this regard. On behalf of myself, the Associate Editors, and the American Cancer Society, I would like to thank Dr. Gladwyn Leiman for her remarkable contribution to the journal. It is with deep personal gratitude that I say she has been a reliable source of inspiration and wisdom that I have tapped regularly. I am highly appreciative of her service and partnership. Thank you, Gladwyn. As a postscript, Gladwyn will be relocating to North Carolina's Raleigh-Durham area. When asked what comes next, Gladwyn replied, “My future plans are to resurrect my right brain, and reenter the worlds of literature, music, and history, which were my major interests before I deviated to medical school. In particular, I want to reengage in Holocaust studies and genealogy, which have been constant unofficial pursuits throughout my life.” For those who would like to extend their congratulations to Gladwyn on her amazing career and send best wishes for her retirement, you can contact her through Cancer Cytopathology at [email protected]. All correspondence will be forwarded to her.
- Research Article
17
- 10.1016/j.whi.2021.12.001
- May 1, 2022
- Women's Health Issues
After Childbirth: Better Data Can Help Align Postpartum Needs with a New Standard of Care.
- Supplementary Content
- 10.1136/bmj.331.7529.1410
- Dec 8, 2005
- BMJ
Pioneer of cervical screeningBetty Macgregor was the cytologist who made northeast Scotland the United Kingdom's first centre for systematic cervical screening.It was because of her published results that screening was...
- Research Article
6
- 10.1002/cncy.22397
- Dec 23, 2020
- Cancer cytopathology
A group of international experts in breast fine needle aspiration biopsy (FNAB) cytopathology, supported by the International Academy of Cytology (IAC), drafted a comprehensive system for reporting breast FNAB cytopathology in 2017-2018. The editorial team produced a survey to assess the international response to the proposed category structure, definitions, and management recommendations in this draft. A web-based survey of 186 questions was generated using the Qualtrics software package (Provo, Utah) supported by the Division of Information Technology at the University of Wisconsin-Madison. The survey was advertised widely-including through the IAC, American Society of Cytopathology, Japanese Society of Clinical Cytology, Papanicolaou Society of Cytopathology, and Australian Society of Cytology and to audiences at national and international meetings-and was available from April to June 2018. The data obtained from the 265 respondents was assessed by the editorial team. The survey provided a snapshot of the current role and use of breast FNAB and the international variations. Demographic questions were followed by specific questions based on the draft category definitions and statements and focused on issues that had generated discussion among the authors, including the FNAB diagnosis of ductal carcinoma in situ. The survey results strongly supported the development of the IAC Yokohama System and informed subsequent discussions among the authors regarding the final text.
- Research Article
2
- 10.1093/ecco-jcc/jjab232.665
- Jan 21, 2022
- Journal of Crohn's and Colitis
P538 Implementation of Kono-S anastomosis as a new standard of surgical care
- Supplementary Content
99
- 10.1159/000499509
- May 21, 2019
- Acta Cytologica
The International Academy of Cytology (IAC) gathered together a group of cytopathologists expert in breast cytology who, working with clinicians expert in breast diagnostics and management, have developed the IAC Yokohama System for Reporting Breast Fine-Needle Aspiration Biopsy (FNAB) Cytology. The project was initiated with the first cytopathology group meeting in Yokohama at the 2016 International Congress of Cytology. This IAC Yokohama System defines five categories for reporting breast cytology, each with a clear descriptive term for the category, a definition, a risk of malignancy (ROM) and a suggested management algorithm. The key diagnostic cytopathology features of each of the lesions within each category will be presented more fully in a subsequent atlas. The System emphasizes that the crucial requirements for diagnostic breast FNAB cytology are a high standard for the performance of the FNAB and for the making of direct smears, and well-trained experienced cytopathologists to interpret the material. The performance indicators of breast FNAB, including specificity and sensitivity, negative predictive value, positive predictive value and ROM stated in this article have been derived from the recent literature. The current practice of breast FNAB has evolved with the increasing use of ultrasound guidance and rapid on-site evaluation. Two recent publications have shown a range of ROM for the insufficient/inadequate category of 2.6–4.8%, benign 1.4–2.3%, atypical 13–15.7%, suspicious of malignancy 84.6–97.1%, and malignant 99.0–100%. The management algorithm in the System provides options because there are variations in the management of breast lesions using FNAB and core-needle biopsy in those countries utilizing the “triple test” of clinical, imaging, and FNAB assessment, and also variations in the availability of CNB and imaging in low- and middle-income countries. The System will stimulate further discussion and research, particularly in the cytological diagnostic features of specific lesions within each category and in management recommendations. This will lead to continuing improvements in the care of patients with breast lesions and possible modifications to the IAC Yokohama System.
- Supplementary Content
28
- 10.1159/000501055
- May 28, 2019
- Acta Cytologica
The International Academy of Cytology (IAC) gathered together a group of cytopathologists expert in breast cytology who, working with clinicians expert in breast diagnostics and management, have developed the IAC Yokohama System for Reporting Breast Fine-Needle Aspiration Biopsy (FNAB) Cytology. The project was initiated with the first cytopathology group meeting in Yokohama at the 2016 International Congress of Cytology. This IAC Yokohama System defines five categories for reporting breast cytology, each with a clear descriptive term for the category, a definition, a risk of malignancy (ROM) and a suggested management algorithm. The key diagnostic cytopathology features of each of the lesions within each category will be presented more fully in a subsequent atlas. The System emphasizes that the crucial requirements for diagnostic breast FNAB cytology are a high standard for the performance of the FNAB and for the making of direct smears, and well-trained experienced cytopathologists to interpret the material. The performance indicators of breast FNAB, including specificity and sensitivity, negative predictive value, positive predictive value and ROM stated in this article have been derived from the recent literature. The current practice of breast FNAB has evolved with the increasing use of ultrasound guidance and rapid on-site evaluation. Two recent publications have shown a range of ROM for the insufficient/inadequate category of 2.6–4.8%, benign 1.4–2.3%, atypical 13–15.7%, suspicious of malignancy 84.6–97.1%, and malignant 99.0–100%. The management algorithm in the System provides options because there are variations in the management of breast lesions using FNAB and core-needle biopsy in those countries utilizing the “triple test” of clinical, imaging, and FNAB assessment, and also variations in the availability of CNB and imaging in low- and middle-income countries. The System will stimulate further discussion and research, particularly in the cytological diagnostic features of specific lesions within each category and in management recommendations. This will lead to continuing improvements in the care of patients with breast lesions and possible modifications to the IAC Yokohama System.
- Research Article
43
- 10.1016/j.jasc.2018.02.005
- Feb 21, 2018
- Journal of the American Society of Cytopathology
Paris Interobserver Reproducibility Study (PIRST)
- Research Article
- 10.1016/j.jasc.2025.05.001
- May 1, 2025
- Journal of the American Society of Cytopathology
Pathologist performed ultrasound guided fine needle aspiration (US-FNA): current status, trends, and insights from the American Society of Cytopathology Sponsored Survey.
- Research Article
1
- 10.1002/(sici)1097-0339(199805)18:5<371::aid-dc15>3.0.co;2-f
- May 1, 1998
- Diagnostic cytopathology
These guidelines were approved by the governing boards of the following six societies represented in the Intersociety Working Group for Cytology Technologies: American Society for Cytotechnology (ASCT), American Society of Clinical Pathologists (ASCP), American Society of Cytopathology (ASC), College of American Pathologists (CAP), International Academy of Cytology (IAC), and Papanicolaou Society of Cytopathology (PSC). The proposed guidelines as written reflect the current status of technologies in early 1997. These guidelines may evolve over time as newer technologies are developed.
- Front Matter
7
- 10.1093/ajcp/109.1.10
- Jan 1, 1998
- American journal of clinical pathology
These guidelines were approved by the governing boards of the following six societies represented in the Intersociety Working Group for Cytology Technologies: American Society for Cytotechnology (ASCT), American Society of Clinical Pathologists (ASCP), American Society of Cytopathology (ASC), College of American Pathologists (CAP), International Academy of Cytology (IAC), and Papanicolaou Society of Cytopathology (PSC). The proposed guidelines as written reflect the current status of technologies in early 1997. These guidelines may evolve over time as newer technologies are developed. Diagn. Cytopathol. 1998;18:371–376. © 1998 Wiley-Liss, Inc.
- Research Article
9
- 10.3138/jvme.0614-063r
- Dec 1, 2014
- Journal of Veterinary Medical Education
Microscopy (skill of using a microscope) and the concepts of cytology (study of cells) and histology (study of tissues) are most often taught in professional veterinary medicine programs through the traditional method of glass slides and light microscopes. Several limiting factors in veterinary training programs are encouraging educators to explore innovative options for teaching microscopy skills and the concepts of cytology and histology. An anonymous online survey was administered through the Colorado Veterinary Medical Association to Colorado veterinarians working in private practice. It was designed to assess their current usage of microscopes for cytological and histological evaluation of specimens and their perceptions of microscope use in their veterinary education. The first part of the survey was answered by 183 veterinarians, with 104 indicating they had an onsite diagnostic lab. Analysis pertaining to the use of the microscope in practice and in veterinary programs was conducted on this subset. Most respondents felt the amount of time spent in the curriculum using a microscope was just right for basic microscope use and using the microscope for viewing and learning about normal and abnormal histological sections and clinical cytology. Participants felt more emphasis could be placed on clinical and diagnostic cytology. Study results suggest that practicing veterinarians frequently use microscopes for a wide variety of cytological diagnostics. However, only two respondents indicated they prepared samples for histological evaluation. Veterinary schools should consider these results against the backdrop of pressure to implement innovative teaching techniques to meet the changing needs of the profession.
- Research Article
- 10.1158/1538-7445.sabcs21-deb2-1
- Feb 15, 2022
- Cancer Research
“Hypofractionation should not be used unless there is a specific rationale concerning the tumor characteristics of doing so”1. These were the words of Gilbert Fletcher, M.D. Anderson Cancer Center, Texas in 1990. So what prompted this bold statement? In 1969, Frank Ellis published his manuscript proposing an isoeffect formula for hypofractionation with a total dose reduction modelled on acute skin reactions2. The Ellis isoeffect formula was intended to be carefully tested, but there was wholesale international adoption as hypofractionation seemed a perfect solution for constrained radiotherapy resources3. This was coupled with lack of quality assurance for patient positioning, field matching and dose prescription. The perfect solution was in fact the perfect storm with many patients with breast cancer suffering serious late normal tissue toxicity including brachial plexopathy. The linear-quadratic model was described subsequently and separated the distinct fractionation sensitivities of early and late-responding normal tissue4. It became clear that total dose needed to be reduced further as the dose per fraction is increased3. In the early 1980’s, John Yarnold, Royal Marsden Hospital, UK read a research manuscript by Bruce Douglas5, which had a profound effect on him and subsequent UK breast radiation research. It challenged the accepted belief that all tumours respond to radiation fractionation in the same way as early-reacting normal tissues. Yarnold hypothesised that breast cancer is as sensitive to fraction size as late-responding normal tissues and if this is so, 2Gy fractions spare tumour and normal tissues equally. Given this apparent lack of advantage, larger fractions were worth testing. At the same time, other researchers globally started to develop breast cancer hypofractionation clinical trials. This important historical background sets scene for this debate: One week of whole breast radiation is the new standard of care. It demonstrates that there is nothing “new” about breast hypofractionation and that there is certainly a “specific rationale concerning the tumor characteristics” that Fletcher called for. It also highlights our united goal as radiation/clinical oncologists to carefully evaluate and report late normal toxicity so earlier mistakes are not repeated. Breast hypofractionation represents more than 3 decades of high quality international clinical trials underpinned by robust quality assurance6-9. The research has been driven by a strong radiobiological rationale and reduced visits for patients and savings for healthcare systems is a happy consequence. During this debate, I will describe the results of the FAST-Forward trial10, address the postulated concerns and conclude why one week of radiotherapy should be the new standard of care.
- Research Article
41
- 10.1007/s10439-017-1906-5
- Aug 28, 2017
- Annals of Biomedical Engineering
A thrombus or blood clot is a solid mass, made up of a network of fibrin, platelets and other blood components. Blood clots can form through various pathways, for example as a result of exposed tissue factor from vascular injury, as a result of low flow/stasis, or in very high shear flow conditions. Embolization of cardiac or vascular originating blood clots, causing an occlusion of the neurovasculature, is the major cause of stroke and accounts for 85% of all stroke. With mechanical thrombectomy emerging as the new standard of care in the treatment of acute ischemic stroke (AIS), the need to generate a better understanding of the biomechanical properties and material behaviour of thrombus material has never been greater, as it could have many potential benefits for the analysis and performance of these treatment devices. Defining the material properties of a thrombus has obvious implications for the development of these treatment devices. However, to-date this definition has not been adequately established. While some experimentation has been performed, model development has been extremely limited. This paper reviews the previous literature on mechanical testing of thrombus material. It also explores the use of various constitutive and computational models to model thrombus formation and material behaviour.
- Research Article
3
- 10.1007/s40620-024-02135-y
- Nov 7, 2024
- Journal of nephrology
Chronic kidney disease (CKD) is widely recognized as a leading and growing contributor to global morbidity and mortality worldwide. Nutritional therapy is the basic treatment for metabolic control, and may contribute to nephroprotection; however, the absence of solid evidence on slowing CKD progression together with poor adherence to dietary prescription limit de facto itsefficacy and prevent itsmore widespread use. Sodium-glucose transport protein 2 inhibitors (SGLT2is) are now considered the new standard of care in CKD; in addition, novel potassium binders, glucagon-like peptide-1 receptor antagonists (GLP1-RAs) and nonsteroidal mineralocorticoid receptor antagonists (nsMRAs) show either direct (SGLT2i, GLP1-RA, nsMRA) or indirect (potassium binders that enable the optimal use of renin-angiotensin-aldosterone system inhibitors) nephroprotective effects. These drugs could potentially lead to a more permissive diet, thereby allowing the patient to reap the benefits of this approach. In particular, SGLT2is, and to a lesser extent also GLP1-RAs and nsMRAsin patients with diabetic kidney disease, can counterbalance hyperfiltration as well as the higher protein intake often recorded in obese patients; on the other hand, potassium binders can facilitate following plant-based diets, which are considered healthy because of the high content of essential micronutrients such as antioxidant vitamins, minerals, alkalies, and fibers. In this review paper, we discuss the current pharmacological paradigm shift that places a new, broader standard of care in light of its interaction with nutritional therapy in order to optimize the global approach to patients with CKDnotondialysis.
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