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      Global Trends of Medical Misadventures Using International Classification of Diseases, Tenth Revision Cluster Y62-Y69 Comparing Pre–, Intra–, and Post–COVID-19 Pandemic Phases: Protocol for a Retrospective Analysis Using the TriNetX Platform

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          Abstract

          Background

          The COVID-19 pandemic has sharpened the focus on health care safety and quality, underscoring the importance of using standardized metrics such as the International Classification of Diseases, Tenth Revision ( ICD-10). In this regard, the ICD-10 cluster Y62-Y69 serves as a proxy assessment of safety and quality in health care systems, allowing researchers to evaluate medical misadventures. Thus far, extensive research and reports support the need for more attention to safety and quality in health care. The study aims to leverage the pandemic’s unique challenges to explore health care safety and quality trends during prepandemic, intrapandemic, and postpandemic phases, using the ICD-10 cluster Y62-Y69 as a key tool for their evaluation.

          Objective

          This research aims to perform a comprehensive retrospective analysis of incidence rates associated with ICD-10 cluster Y62-Y69, capturing both linear and nonlinear trends across prepandemic, intrapandemic, and postpandemic phases over an 8-year span. Therefore, it seeks to understand how these trends inform health care safety and quality improvements, policy, and future research.

          Methods

          This study uses the extensive data available through the TriNetX platform, using an observational, retrospective design and applying curve-fitting analyses and quadratic models to comprehend the relationships between incidence rates over an 8-year span (from 2015 to 2023). These techniques will enable the identification of nuanced trends in the data, facilitating a deeper understanding of the impacts of the COVID-19 pandemic on medical misadventures. The anticipated results aim to outline complex patterns in health care safety and quality during the COVID-19 pandemic, using global real-world data for robust and generalizable conclusions. This study will explore significant shifts in health care practices and outcomes, with a special focus on geographical variations and key clinical conditions in cardiovascular and oncological care, ensuring a comprehensive analysis of the pandemic’s impact across different regions and medical fields.

          Results

          This study is currently in the data collection phase, with funding secured in November 2023 through the Ricerca Corrente scheme of the Italian Ministry of Health. Data collection via the TriNetX platform is anticipated to be completed in May 2024, covering an 8-year period from January 2015 to December 2023. This dataset spans pre-pandemic, intra-pandemic, and early post-pandemic phases, enabling a comprehensive analysis of trends in medical misadventures using the ICD-10 cluster Y62-Y69. The final analytics are anticipated to be completed by June 2024. The study's findings aim to provide actionable insights for enhancing healthcare safety and quality, reflecting on the pandemic's transformative impact on global healthcare systems.

          Conclusions

          This study is anticipated to contribute significantly to health care safety and quality literature. It will provide actionable insights for health care professionals, policy makers, and researchers. It will highlight critical areas for intervention and funding to enhance health care safety and quality globally by examining the incidence rates of medical misadventures before, during, and after the pandemic. In addition, the use of global real-world data enhances the study’s strength by providing a practical view of health care safety and quality, paving the way for initiatives that are informed by data and tailored to specific contexts worldwide. This approach ensures the findings are applicable and actionable across different health care settings, contributing significantly to the global understanding and improvement of health care safety and quality.

          International Registered Report Identifier (IRRID)

          PRR1-10.2196/54838

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          Most cited references19

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          Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I.

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            To contextualise the degree of harm that comes from unsafe medical care compared with individual health conditions using the global burden of disease (GBD), a metric to determine how much suffering is caused by individual diseases.
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              Unsafe medical care may cause substantial morbidity and mortality globally, despite imprecise estimates of the magnitude of the problem. To better understand the extent and nature of the problem of unsafe care, the WHO World Alliance for Patient Safety commissioned an overview of the world's literature on patient safety research. Major patient safety topics were identified through a consultative and investigative process and were categorised into the framework of structure, process and outcomes of unsafe care. Lead experts examined current evidence and identified major knowledge gaps relating to topics in developing, transitional and developed nations. The report was reviewed by internal and external experts and underwent improvements based on the feedback. Twenty-three major patient safety topics were examined. Much of the evidence of the outcomes of unsafe care is from developed nations, where prevalence studies demonstrate that between 3% and 16% of hospitalised patients suffer harm from medical care. Data from transitional and developing countries also suggest substantial harm from medical care. However, considerable gaps in knowledge about the structural and process factors that underlie unsafe care globally make solutions difficult to identify, especially in resource-poor settings. Harm from medical care appears to pose a substantial burden to the world's population. However, much of the evidence base comes from developed nations. Understanding the scope of and solutions for unsafe care for the rest of the world is a critical component of delivering safe, effective care to all of the world's citizens.
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                Author and article information

                Contributors
                Journal
                JMIR Res Protoc
                JMIR Res Protoc
                ResProt
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                1929-0748
                2024
                17 April 2024
                : 13
                : e54838
                Affiliations
                [1 ] Health Professions Research and Development Unit IRCCS Policlinico San Donato San Donato Milanese Italy
                [2 ] Department of Biomedical Sciences for Health University of Milan Milano Italy
                [3 ] Department of Clinical and Molecular Medicine Sapienza University of Rome Rome Italy
                [4 ] Nursing, Technical and Rehabilitation Department DaTeR Azienda Unità Sanitaria Locale di Bologna Bologna Italy
                [5 ] Department of Clinical and Experimental Medicine University of Messina Messina Italy
                [6 ] Centre of Excellence for Nursing Scholarship Rome Italy
                [7 ] Laboratory of Biostatistics and Data Management Scientific Directorate IRCCS Policlinico San Donato San Donato Milanese Italy
                [8 ] Scientific Directorate IRCCS Policlinico San Donato San Donato Milanese Italy
                [9 ] Frances Payne Bolton School of Nursing and School of Medicine Case Western Reserve University Cleveland, OH United States
                Author notes
                Corresponding Author: Rosario Caruso rosario.caruso@ 123456grupposandonato.it
                Author information
                https://orcid.org/0000-0002-7736-6209
                https://orcid.org/0000-0003-2641-4044
                https://orcid.org/0000-0002-6373-8163
                https://orcid.org/0000-0001-7933-8490
                https://orcid.org/0000-0003-0440-6940
                https://orcid.org/0000-0002-8171-8203
                https://orcid.org/0000-0003-3508-2352
                https://orcid.org/0009-0002-7329-8015
                https://orcid.org/0000-0003-3144-9364
                https://orcid.org/0000-0001-8530-6284
                https://orcid.org/0000-0002-6472-1275
                Article
                v13i1e54838
                10.2196/54838
                11025602
                38630516
                a636f1ee-1906-47b9-a7c3-3b9f0952b7f6
                ©Rosario Caruso, Marco Di Muzio, Emanuele Di Simone, Sara Dionisi, Arianna Magon, Gianluca Conte, Alessandro Stievano, Emanuele Girani, Sara Boveri, Lorenzo Menicanti, Mary A Dolansky. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 17.04.2024.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                : 23 November 2023
                : 26 January 2024
                : 2 February 2024
                : 5 February 2024
                Categories
                Protocol
                Protocol
                Custom metadata
                The proposal for this study was peer reviewed by the Ricerca Corrente fund of IRCCS Policlinico San Donato (Italy).

                covid-19,curve-fitting analyses,health care quality,health care safety,international classification of diseases, tenth revision,icd-10,incidence rates,safety,trinetx

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