International Agency for Research on Cancer (IARC)

Sagert, Kelly Boyer

doi:10.4135/9781412963855.n637

Cited by 5 publications

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“…Одним из наиболее важных значимых факторов риска ХК является длительная персистенция в организме печеночных трематод O. viverrini и C. sinensis, включенных в реестр биологических канцерогенов 1-й группы с доказанной онкогенностью для людей на основании результатов исследований, проведенных в Юго-Восточной Азии [11]. Согласно отчету Международного агентства по изучению рака ВОÇ (2019) [43].…”

Section: источники данныхunclassified

“…Международное агентство по изучению рака Всемирной организации здравоохранения (ВОÇ) включило печеночных трематод O. viverrini и C. sinensis в реестр биологических канцерогенов, основываясь на результатах исследований, проведенных в Юго-Восточной Азии, продемонстрировавших взаимосвязь между инвазией O. viverrini, C. sinensis и холангиокарциномой (ХК) [9][10][11].…”

Section: Introductionunclassified

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Association between cholangiocarcinoma and liver flukes: review of epidemiological studies

et al. 2020

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РЕЗЮМЕСогласно официальной медицинской статистике, случаи инвазии, вызываемые печеночными трематодами Opisthorchis felineus, Opisthorchis viverrini и Clonorchis sinensis, ежегодно регистрируются как в регионах Юго-Восточной Азии, так и в европейских странах, в Российской Федерации, являясь причиной заболеваний органов пищеварительной системы у населения ýндемичных регионов. Цель обзора -анализ результатов ýпидемиологических исследований, посвященных оценке взаимосвязи злокачественных новообразований гепатобилиарной системы и печеночных трематодозов, вызванных гельминтами семейства Opisthorchiidae. Изучены оригинальные исследования, опубликованные за период 1974-2019 гг. и размещенные в базах данных MEDLINE и научной ýлектронной библиотеки eLIBRARY. Проведенные исследования свидетельствуют, что холангиокарцинома является значимой медико-социальной проблемой в ýндемичных по трематодозам регионах Юго-Восточной Азии ввиду отсутствия специфических симптомов, длительного бессимптомного течения, резистентности к терапии и высокой смертности пациентов. Длительная персистенция в организме печеночных трематод Opisthorchis viverrini и Clonorchis sinensis ассоциирована со значительным риском развития холангиоцеллюлярного рака. Требуется проведение ýпидемиологического многоцентрового исследования для установления взаимосвязи инвазии Opisthorchis felineus и холангиокарциномы у населения ýндемичных регионов Российской Федерации. Ключевые слова: холангиокарцинома, Opisthorchis viverrini, Clonorchis sinensis, Opisthorchis felineus, рак печени, обзор, ýпидемиологическое исследование. Конфликт интересов. Авторы декларируют отсутствие явных и потенциальных конфликтов интересов, связанных с публикацией настоящей статьи. Источник финансирования. Исследование выполнено при поддержке Российского фонда фундаментальных исследований, грант «Разработка алгоритма ранней диагностики злокачественных новообразований гепатобилиарного тракта, ассоциированных с инвазией Opisthorchis felineus, у населения ýндемичных регионов», договор от 22.

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Section: источники данныхunclassified

Section: Introductionunclassified

Association between cholangiocarcinoma and liver flukes: review of epidemiological studies

et al. 2020

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Usability Testing of a Digitized Interventional Prehabilitation Tool for Health Care Professionals and Patients Before Major Surgeries: Formative and Summative Evaluation

Schnitzbauer,

Detemble,

Faqar-Uz-Zaman

et al. 2024

JMIR Form Res

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Background The development of a medical device requires strict adherence to regulatory processes. Prehabilitation in this context is a new area in surgery that trains, coaches, and advises patients in mental well-being, nutrition, and physical activity. As staff is permanently drained from clinical care, remote and digital solutions with real-time assessments of data, including patient-related outcome reporting, may simplify preparation before major surgeries. Objective This study aimed to evaluate the usability engineering process for the Prehab App, a newly developed medical device, in order to identify and adapt any design and usability flaws found. Methods We hypothesized that formative and summative usability testing would achieve 80% interrater and intrarater reliability and consistency and that the safety-relevant scenarios would uncover undetected risks of the medical device (stand-alone software class IIa). In total, 8 experts and 8 laypersons (patients and potential patients) were asked to evaluate paper-based mockups, followed by an evaluation of the minimal viable product (MVP) of the Prehab App at least more than 8 weeks later after instruction and training. The experts had to face 5 and the laypersons 6 usability scenarios. Their evaluations were measured with the Mobile App Rating Scale (MARS) and trustworthiness checklists (range 0-64, with higher scores indicating trustworthiness), and the usability scenarios were evaluated with the After Scenario Questionnaire (ASQ) and a judgment by an observer. The time taken for the scenarios was also recorded. Results MARS achieved constant scores of more than 4 out of 5 points for both experts and laypersons. The mean trustworthiness score was 51.3 (SD 2.7) for the experts and 50.8 (SD 2.1) for the laypersons (P=.68) in task I. The interrater correlation, shown by the Fleiss-Kappa value, was 0.87 (range 0.85-0.89) for all raters (N=16), 0.86 (range 0.82-0.91) for the experts (n=8, 50%), and 0.88 (range 0.84-0.93) for the laypersons (n=8, 50%), reflecting almost perfect agreement between the raters. This indicated the high quality of the usability. The usability scenarios were performed with ease, except for the onboarding part, when the wearable was required to be connected; this took a considerable amount of time and was recognized as a challenge to good usability. Conclusions The formative and summative evaluation of the Prehab App design resulted in good-to-acceptable results of the design and usability of the critical and safety-relevant areas of the medical device and stand-alone software. Usability testing improves medical devices early in the design and development process, reduces errors, and mitigates risks, and in this study, it delivered a profound ethical and medical justification for a randomized controlled trial (RCT) of the Prehab App in a remote setting as a next step in the development process. Trial Registration German Registry for Clinical Trials (DRKS00026985); https://drks.de/search/en/trial/DRKS00026985

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Usability Testing of a Digitized Interventional Prehabilitation Tool for Health Care Professionals and Patients Before Major Surgeries: Formative and Summative Evaluation (Preprint)

Schnitzbauer,

Detemble,

Faqar-Uz-Zaman

et al. 2024

Preprint

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BACKGROUND The development of a medical device requires strict adherence to regulatory processes. Here the usability engineering process for The Prehab App is displayed. Prehabilitation in this context is a new area in surgery that trains, coaches, and advises patients in mental well-being, nutrition, and physical activity. As staff is permanently drained from clinical care, remote and digital solutions with real-time assessments of data including patient-related outcome reporting may simplify preparation before major surgeries. OBJECTIVE The hypothesis was, that formative and summative usability testing would achieve 80% interrater, and intra-rater reliability and consistency and that the safety-relevant scenarios would uncover undetected risks of the medical device (standalone software class IIa). METHODS Eight experts and eight patients were asked to evaluate paper-based mockups, followed by an evaluation of the minimal viable product of The Prehab App at least more than 8 weeks later after instruction and training. The experts had to perform 5 and the patients 6 usability scenarios. The evaluations were measured with the MARS (mobile app rating scale) and Trustworthiness checklists (range 0-64 with higher scores indicating trustworthiness), usability scenarios received evaluation with the ‘After scenario questionnaire’ and a judgment by an observer. The time of performing the scenarios was recorded. RESULTS MARS achieved constant scores of more than 4 out of 5 points for experts and patients. The Trustworthiness score was 51,3 ± 2,7 in the experts and 50,8 ± 2,1 in the lays group (p=0,68) in Task I. The interrater correlation, shown by the Fleiss-Kappa value was 0,87 [0,85;0,89] for all raters (n=18) reflecting almost perfect agreement, and 0,86 [0,82; 0,91] for the expert group (n=8) and 0,88 [0,84; 0,93] for the lays group (n=8) reflecting the almost perfect agreement between the raters. This indicated the high quality of the usability. The usability scenarios were performed with ease except for the onboarding part when connecting the wearable was required. This took a considerable amount of time and was recognized as a challenge for good usability. CONCLUSIONS The formative and summative evaluation of ‘The Prehab App’ design resulted in very good to acceptable results of the design and usability of the critical and safety-relevant areas of the medical device and standalone software. Usability testing improves medical devices early in the design and development process, reduces errors, mitigates risks, and delivers a profound ethical and medical justification for a randomized controlled trial of ‘The Prehab App’ in a remote setting as a next step in the development process. CLINICALTRIAL The trial received a positive vote by the Frankfurt University institutional review board (IRB) on November 11th, 2021 (2021-483-MDR) and was approved by the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) on February 7th, 2022 (German Medical Devices Information and Database System: DMIDS: 00013655; European Database on Medical Devices: EUDMAD: CIV-21-07-037311; German Study Registry: DRKS00026985).

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International Agency for Research on Cancer (IARC)

Cited by 5 publications

References 0 publications

Association between cholangiocarcinoma and liver flukes: review of epidemiological studies

Association between cholangiocarcinoma and liver flukes: review of epidemiological studies

Usability Testing of a Digitized Interventional Prehabilitation Tool for Health Care Professionals and Patients Before Major Surgeries: Formative and Summative Evaluation

Usability Testing of a Digitized Interventional Prehabilitation Tool for Health Care Professionals and Patients Before Major Surgeries: Formative and Summative Evaluation (Preprint)

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