Validation of the rates of adverse event incidence in administrative healthcare data through patient chart review: A scoping review protocol

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Administrative healthcare data provide a coded summary of a patient and their encounter with the healthcare system. These aggregated datasets are often used to inform research and decisions relating to health service planning and therefore it is vital that they are accurate and reliable. Given the reported inaccuracy of these datasets for detecting and recording adverse events, there have been calls for validation studies to explore their reliability and investigate further their potential to inform research and health policy. Researchers have since carried out validation studies on the rates of adverse events in administrative data through chart reviews therefore, it seems appropriate to identify and chart the evidence and results of these studies within a scoping review. Methods The scoping review will be conducted in accordance with the Joanna Briggs Institute (JBI) methodology for scoping reviews. A search of databases such as PubMed, CINAHL, ScienceDirect and Scopus will be conducted in addition to a search of the reference lists of sourced publications and a search for grey literature. Following this, Covidence will be used to screen the sourced publications and subsequently extract data from the included sources. A numerical summary of the literature will be presented in addition to a charting based on the qualitative content analysis of the studies included. Conclusions This protocol provides the structure for the conduct of a review to identify and chart the evidence on validation studies on rates of adverse events in administrative healthcare data. This review will aim to identify research gaps, chart the evidence of and highlight any flaws within administrative datasets to improve extraction and coding practices and enable researchers and policy makers to use these data to their full potential. 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HRB Open Res 2024, 6 :21 ( https://doi.org/10.12688/hrbopenres.13706.2 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Study Protocol Revised Validation of the rates of adverse event incidence in administrative healthcare data through patient chart review: A scoping review protocol [version 2; peer review: 2 approved, 1 approved with reservations] Anna Connolly https://orcid.org/0000-0003-4249-8137 1 , Marcia Kirwan https://orcid.org/0000-0001-7201-0281 1 , Anne Matthews https://orcid.org/0000-0002-4845-869X 1 Anna Connolly https://orcid.org/0000-0003-4249-8137 1 , Marcia Kirwan https://orcid.org/0000-0001-7201-0281 1 , Anne Matthews https://orcid.org/0000-0002-4845-869X 1 PUBLISHED 12 Dec 2024 Author details Author details 1 School of Nursing, Psychotherapy and Community Health, Dublin City University, Dublin, Leinster, Ireland Anna Connolly Roles: Conceptualization, Data Curation, Formal Analysis, Methodology, Visualization, Writing – Original Draft Preparation Marcia Kirwan Roles: Funding Acquisition, Project Administration, Supervision, Writing – Review & Editing Anne Matthews Roles: Project Administration, Supervision, Writing – Review & Editing OPEN PEER REVIEW DETAILS REVIEWER STATUS Abstract Background Patient safety is a key issue for health systems and a growing global public health challenge. Administrative healthcare data provide a coded summary of a patient and their encounter with the healthcare system. These aggregated datasets are often used to inform research and decisions relating to health service planning and therefore it is vital that they are accurate and reliable. Given the reported inaccuracy of these datasets for detecting and recording adverse events, there have been calls for validation studies to explore their reliability and investigate further their potential to inform research and health policy. Researchers have since carried out validation studies on the rates of adverse events in administrative data through chart reviews therefore, it seems appropriate to identify and chart the evidence and results of these studies within a scoping review. Methods The scoping review will be conducted in accordance with the Joanna Briggs Institute (JBI) methodology for scoping reviews. A search of databases such as PubMed, CINAHL, ScienceDirect and Scopus will be conducted in addition to a search of the reference lists of sourced publications and a search for grey literature. Following this, Covidence will be used to screen the sourced publications and subsequently extract data from the included sources. A numerical summary of the literature will be presented in addition to a charting based on the qualitative content analysis of the studies included. Conclusions This protocol provides the structure for the conduct of a review to identify and chart the evidence on validation studies on rates of adverse events in administrative healthcare data. This review will aim to identify research gaps, chart the evidence of and highlight any flaws within administrative datasets to improve extraction and coding practices and enable researchers and policy makers to use these data to their full potential. READ ALL READ LESS Keywords Administrative healthcare data, Patient safety, Adverse events, Validation, Chart review Corresponding Author(s) Anna Connolly ( [email protected] ) Close Corresponding author: Anna Connolly Competing interests: No competing interests were disclosed. Grant information: Health Research Board [ILP-HSR-2022-009]. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Copyright: © 2024 Connolly A et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Connolly A, Kirwan M and Matthews A. Validation of the rates of adverse event incidence in administrative healthcare data through patient chart review: A scoping review protocol [version 2; peer review: 2 approved, 1 approved with reservations] . HRB Open Res 2024, 6 :21 ( https://doi.org/10.12688/hrbopenres.13706.2 ) First published: 23 Mar 2023, 6 :21 ( https://doi.org/10.12688/hrbopenres.13706.1 ) Latest published: 12 Dec 2024, 6 :21 ( https://doi.org/10.12688/hrbopenres.13706.2 ) Revised Amendments from Version 1 The manuscript has been amended to provide further clarity based on the reviewers’ feedback and comments. The manuscript has also been reduced to remove redundant text as per the feedback received. The manuscript has also amended to place further emphasis on the prevention of adverse events and the improvement of quality care as the ultimate goal of validating administrative datasets and ensuring their accuracy. Furthermore, the potential benefit of this work to highlight the capacity of linking accurate administrative data with staffing information to demonstrate the impact of safe/unsafe staffing has also been addressed in the revised manuscript. The manuscript has been amended to provide further clarity based on the reviewers’ feedback and comments. The manuscript has also been reduced to remove redundant text as per the feedback received. The manuscript has also amended to place further emphasis on the prevention of adverse events and the improvement of quality care as the ultimate goal of validating administrative datasets and ensuring their accuracy. Furthermore, the potential benefit of this work to highlight the capacity of linking accurate administrative data with staffing information to demonstrate the impact of safe/unsafe staffing has also been addressed in the revised manuscript. See the authors' detailed response to the review by Keith Marsolo See the authors' detailed response to the review by Angela Flynn READ REVIEWER RESPONSES Introduction Patient safety is a key issue for health systems and a growing global public health challenge. The human cost of patient safety incidents is high with adverse events causing injury, disability or death and resulting in suffering for patients and family members. The financial and economic burdens of patient safety incidents are also of concern with further healthcare expenditure required for increased length of stays in hospital and additional tests, treatments and healthcare to be provided to patients ( WHO, 2021b ). The Harvard Medical Practice Study ( Brennan et al. , 1991 ) and the Institute of Medicine (2000) identified high rates of adverse events in hospital admissions and marked the beginning of the patient safety movement. This led to rates of adverse events becoming an important quality indicator across health systems. Adverse events have since been reported and measured however, challenges associated with the accuracy of their recording in administrative data has been widely acknowledged ( Kim et al. , 2022 ; Rodrigo-Rincon et al. , 2015 ). Evidently, patient safety is a key healthcare quality concern and with adverse events as main contributors to patient harm, their monitoring and measurement is a major priority. Routinely collected healthcare data are regularly collected for purposes other than research ( Welk & Kwong, 2017 ). These data, frequently called administrative data, capture the patient’s characteristics, their diagnoses, treatments and procedures and, essentially provide a coded summary of the patient and their encounter with the healthcare system ( Healthcare Pricing Office, 2020 ). The key events of a patient’s stay in hospital are documented in a discharge summary within their clinical chart or in their electronic health record (EHR). Once a patient has been discharged from hospital, their chart is translated into alphanumerical data by professional coding specialists ( Tang et al. , 2017 ). In addition to a patient’s discharge summary, clinical coders may also code information in documents such as nursing notes, consultation reports, progress notes, operative reports, pre- and post-operative reports and pathology reports ( Healthcare Pricing Office, 2020 ). Nursing notes have previously been identified as important sources of data for clinical coders ( Alonso et al. , 2020 ; Doktorchik et al. , 2020 ; Lucyk et al. , 2017 ) and are particularly insightful in relation to identifying adverse events such as pressure injuries, which are a well-recognised quality indicator ( Weller et al. , 2022 ). The data captured by the alphanumerical codes include patient diagnoses, procedures, hospital services used and any complications that arose during a patient’s stay. Various classification systems such as the International Classification of Diseases (ICD) are used to code this data. The ICD translates diagnoses and other health-related issues from words into alphanumerical data, allowing for an efficient method of storing, retrieving, and analysing data ( WHO, 2016 ). Coding systems such as ICD allow for a consistent and standard way of recording, reporting and monitoring diseases. ICD is the is used by all members states of WHO, therefore data can be shared, understood and compared across hospitals, regions and countries ( WHO, 2023a ). Various derived classifications or extensions of the fundamental ICD classifications have been developed and are used to monitor diagnoses in specific areas or settings ( WHO, 2023b ). Clinical coders follow clearly defined ICD coding guidelines to assign alphanumeric codes to each diagnosis or event recorded in a patient’s chart ( O’Malley et al. , 2005 ). As the most widely used classification of diseases, ICD has had 10 iterations since 1900 ( O’Malley et al. , 2005 ). The 10 th revision of the ICD (ICD-10), which contains more than 155,000 codes ( DiSantostefano, 2009 ), has been widely used since its development about 30 years ago ( WHO, 2021a ). An 11 th revision of the ICD (ICD-11 was adopted by World Health Assembly in 2019 and came into effect in 2022 ( WHO, 2023c ). Various other coding systems such as the Current Procedural Terminology (CPT), which was developed by the American Medical Association, are used to capture and assign codes to aspects of healthcare data ( Dotson, 2013 ) however, ICD is recognised globally with all WHO member states committed to using this classification system. Administrative data are often used at national and international levels in health service planning and to inform policy and epidemiological, clinical and biomedical research ( Hemkens et al. , 2016 ). They have also been utilised for carrying out audits, developing financial strategies and determining the distribution of health resources ( Burns et al. , 2012 ). Their use in the evaluation of the quality of health care delivery has also been well-recognised ( Clarke et al. , 2019 ). Given that these datasets are often used for purposes other than those for which they were initially collected, their use in research and evaluation has been labelled as a secondary use ( Jorm, 2015 ). Administrative data can contain rich and valuable information and their use in research has been increasingly recognised. These databases are advantageous for research as they allow research questions that require large sample sizes to be answered ( Harron et al. , 2017 ). Their potential to inform research to enhance the efficiency of health systems and improve population health is well-documented and has led to their increased use in research ( Jorm, 2015 ; Mitchell & Braithwaite, 2021 ; Moorthie et al. , 2022 ). Patient safety researchers in particular have been increasingly recognising the potential of using administrative data for research purposes and for the monitoring and reporting of patient safety events ( Raleigh et al. , 2008 ). Given the association between lower registered nurse staffing levels, increased mortality rates and other adverse outcomes ( Griffiths et al. , 2016 ), validating administrative datasets and ensuring their accuracy may also be beneficial in encouraging the potential for these datasets to be linked to nurse staffing data to demonstrate the impact of nurse staffing on patient outcomes and highlight areas for improvement. Given that these data are used to inform research that may help to improve patients’ health and well-being and inform decisions that will impact on the quality of care that patients receive, it is vital that these administrative datasets are of high-quality and that precise and accurate diagnostic codes are used to generate them ( Gologorsky et al. , 2014 ; Ibrahim et al. , 2021 ). Accurate measurement of adverse events is central to improving patient safety and healthcare quality by allowing priority areas to be identified, improvement strategies to be designed and implemented interventions to be evaluated ( Classen et al. , 2011 ). Accurate data on adverse events may contribute to the development, implementation and evaluation of more targeted and evidence-based patient safety interventions that can prevent adverse events and improve quality of care ( Dillner et al. , 2023 ). Although these datasets can provide rich and detailed information, they are subject to limitations. Previous studies indicate that administrative datasets are not always accurate and therefore, may contribute to inaccuracies in research and lead to poorly informed decisions ( McGuckin et al. , 2022 ; Nicholls et al. , 2017 ). In particular, the inaccuracy of rates of adverse events in administrative data has been previously identified ( Kim et al. , 2022 ). Coding of primary diagnoses and procedures in administrative data is generally accurate however, coding of secondary diagnoses is less complete and therefore, adverse events rates are often underestimated ( Raleigh et al. , 2008 ). Various challenges associated with using administrative data in research have been reported. Such challenges include not all data being abstracted from the patient chart, coded and represented in the database, incomplete data, difficulty determining the number of out-patient visits due to imprecise coding and difficulty capturing all relevant tests due to various diagnostic codes being used for the same test ( McGuckin et al. , 2022 ). The inconsistency in the definitions and terminology used in practice have previously been identified by Naessens et al. (2009) as another challenge to the accurate reporting of patient safety issues. Given that these administrative datasets are generated for purposes other than research, their accuracy and appropriateness for detecting adverse events is varied and their poor representation in some coding schemes has also previously been reported ( Bates et al. , 2003 ). The limited accuracy and variability of rates of hospital acquired infections in administrative data has also been identified as a challenge associated with using these datasets for research or benchmarking purposes. This has also resulted in calls for validation of these datasets and improvement of the algorithms used to generate them ( van Mourik et al. , 2015 ). Although the inaccuracy of administrative data for recording rates of adverse events has been previously reported by researchers such as Walther et al. (2021) , who identified poor recording of postpartum haemorrhage within administrative data, the potential of these datasets to provide accurate information is also being recognised. Ackroyd-Stolarz et al. (2014) found a relatively high degree of accuracy in such datasets for identifying adverse events in older patients, therefore demonstrating the potential value of these datasets to inform research and improve patient safety. Given the lack of consistency in the accuracy of these datasets for recording adverse events, there have been calls for validation studies to explore their reliability and investigate further their potential to inform research and health policy ( Ehrenstein et al. , 2016 ; Jorm, 2015 ; Nicholls et al. , 2017 ). Again, the potential of these datasets to inform research and policy in relation to patient safety and the human and economic cost of adverse events is evident, however specific calls for validating rates of adverse events within these datasets have been made ( Raleigh et al. , 2008 ; van Mourik et al. , 2015 ). Many researchers have since carried out validation studies on various administrative datasets therefore, it seems necessary to chart the evidence and results of these studies within this scoping review. Validating administrative datasets is vital in determining the reliability and credibility of research based on this data and a common way of validating such data by manually comparing the coded data to the data recorded in a patient’s healthcare record ( Nissen et al. , 2019 ). Patient charts have been referred to as the ‘gold standard’ reference point in many validation studies ( Ehrenstein et al. , 2016 ), therefore this scoping review aims to present an overview of how this method of validating administrative data has been used by previous researchers. Various methodological approaches such as the Harvard Medical Practice Study (HMPS) and the Global Trigger Tool (GTT) can be used to conduct chart reviews. The HMPS method is a two-stage approach involving a nurse review for the triggering of charts, followed by a physician review of triggered charts to confirm rates of patient safety incidents using set definitions ( Brennan et al. , 1991 ) The GTT was developed by the Institute for Healthcare Improvement in response to demands for a less labour-intensive approach to chart reviewing. This two-stage approach involves a 20-minute screening phase for a comprehensive list of triggers, followed a physician review of the triggers using broader definitions to confirm the occurrence of an adverse event ( Rafter et al. , 2015 ). The HMPS method is a two-stage approach involving a nurse review for the triggering of charts, followed by a physician review of triggered charts to confirm rates of patient safety incidents using set definitions ( Brennan et al. , 1991 ) The GTT was developed by the Institute for Healthcare Improvement in response to demands for a less labour-intensive approach to chart reviewing. This two-stage approach involves a 20-minute screening phase for a comprehensive list of triggers, followed a physician review of the triggers using broader definitions to confirm the occurrence of an adverse event ( Rafter et al. , 2015 ). Inclusion criteria In line with the JBI methodological framework for carrying out scoping reviews ( Peters et al. , 2020 ), the inclusion and exclusion criteria for studies that may potentially be included in the review will be defined by the population, concept and context screening criteria ( Table 1 ). Table 1. Inclusion and exclusion criteria. Inclusion Criteria Exclusion Criteria Population Sources that report on data derived from hospital-based patients. Sources that report on data relating to any other population than hospital-based patients. Concept Sources that report on the validation of rates of adverse events in administrative data through reviews of patient charts. Sources that do not primarily focus on the validation of rates of adverse events in administrative data through chart reviewing. Context Validation studies that have been conducted in hospital- based settings. There will be no limits placed on geographical location of where sources of evidence have been published. Studies that report on validating data in any other setting than hospital-based settings. Types of Evidence Sources Full text peer-reviewed and non-peer reviewed sources ( e.g., grey literature). Duplications and sources of evidence that cannot be made available in full text. Language Sources available in English. Sources published in languages other than English. Time period Sources of evidence published between 1991 and 2023. Sources of evidence published before 1991. Population As this is a protocol for a scoping review exploring the use of chart reviews to validate rates of adverse events in administrative data, the population of interest is hospital-based patients. These are Patients who have been discharged from hospital and have had the information within their medical chart extracted, assigned ICD codes, and recorded in administrative data Hospital-based patients’ data will have been used to inform the publications that will be included in this scoping review, therefore making them the population of interest in this review. This research will seek to focus on identifying and charting the evidence of reviewing hospital-based patient’s charts as a method of carrying out validation studies on rates of adverse events in administrative datasets. Concept Validating the accuracy of the coding of administrative data is key for ensuring that the policy, practice and research informed by such datasets is credible and robust ( Nicholls et al. , 2017 ). A review of patient charts is a common and effective way of validating the accuracy of administrative data as it allows the coded data recorded in the administrative dataset to be compared to the data maintained within hospital notes or discharge summaries within patient charts ( Burns et al. , 2012 ). The chart review methodology is an efficient way of determining whether the administrative data is an accurate reflection of the patient’s physical medical chart ( Nissen et al. , 2019 ). The concept explored in this scoping review will be the validation of rates of adverse events in administrative data through chart review. Context Validation studies that have been conducted in hospital-based settings will be considered for inclusion in this review. Chart reviews that have been conducted as part of a validation of rates of adverse events in administrative datasets that have been carried out in any country will be included in this review. There will be no limitation on the context of the administrative data in order to allow a comprehensive review to be carried out. Types of evidence sources The types of sources of evidence to be included in this review will be left open to allow a comprehensive review of all available literature to be carried out. This will allow for the inclusion of various types of publications and therefore, should provide an in-depth presentation of the previous literature published in relation to using chart reviews to validate administrative data. Methods This scoping review will be conducted in accordance with the Joanna Briggs Institute (JBI) methodology for scoping review ( Peters et al. , 2020 ). The JBI methodological framework will be used to guide this scoping review and ensure that the review is carried out appropriately. Search strategy The sources of evidence that will be included in this scoping review will be identified and collated using a three-step process as outlined by the JBI ( Peters et al. , 2020 ). The first step of this process will involve an initial search of two databases. The databases included in this initial search will be PubMed (MEDLINE) and CINAHL. Following this preliminary search, an analysis of the text words in the titles and abstracts of identified papers will be carried out. The indexing terms used to describe the retrieved papers will also be analysed. The second step of this process will involve using the identified keywords and index terms to perform a second search of all included databases. The databases included in this step will include PubMed (MEDLINE), CINAHL, Web of Science and Scopus. The third and final step of this process will involve a search of the reference lists of identified publications for additional sources of materials to be included in this scoping review. The reference lists of all publications selected from full text or those included in the review will be searched in order to ensure a comprehensive and in-depth search for existing literature. A search for grey literature will also be conducted to ensure that the review is as thorough as possible ( Arksey & O’ Malley, 2005 ). Grey literature refers to literature that is not commercially published and not usually available within standard databases. Examples of such literature include government reports, conference proceedings, theses and dissertations. A search for this type of literature is beneficial as many researchers publish through other means, such as those mentioned above, and therefore, this allows for the inclusion of a wider scope of material. Also, although such materials may not be included in the final scoping review, they can aid in identifying data sources, research currently being undertaken in the area or complete study reports ( Pawliuk et al. , 2021 ). Sources included in this scoping review will be limited to publications written in English as it will not be feasible for the research team to translate publications published in other languages into English. Literature published over the past 30 years, between 1991 and 2023, will be eligible for inclusion in this study. This time period has been chosen as the patient safety movement was instigated by Brennan et al. (1991) about 30 years ago following their study that investigated the incidence of adverse events and negligence in hospitalised patients through the use of chart reviews. A librarian from Dublin City University has been consulted and their advice was sought in relation to developing a sample search strategy ( Table 2 ). Advice from the librarian will continue to be sought in relation to the search strategy to ensure that a comprehensive search of the available literature is completed. The research team will continue to work closely with the librarian throughout the data collection phase of the scoping review to make certain that repetitions of the search strategy result in all key and relevant literature being gathered. Table 2. Sample search strategy. Search Search Terms S1 “discharge data” OR "hospital discharge data" OR “routinely collected data” OR "routinely collected discharge data" OR “administrative data” OR "administrative health data" OR "healthcare administrative data" S2 verif* OR valid* OR compar* OR evaluat* S3 S1 AND S2 S4 "chart review" OR "record review" OR "medical record review" OR "clinical notes" OR "retrospective chart review" S5 S3 AND S4 S6 "adverse event*" OR "adverse outcome*" OR "healthcare acquired complication*" OR "patient safety incident*" S7 S5 AND S6 Study selection After the search for literature to be potentially included in this scoping review, all identified publications will be gathered and their citations will be stored in the bibliographic software Zotero. The review management tool Covidence will be used to screen the collected publications and subsequently extract data from included sources. The references of the sourced publications will be imported to Covidence from Zotero and any duplicates will be automatically identified and removed. Using Covidence, two members of the research team will independently screen each of the imported studies for inclusion based on title and abstract examination. The researchers will individually assess the eligibility of each publication for inclusion in the review by making reference to the inclusion criteria. The researchers will each have the option of selecting yes, no or maybe at this stage of the selection process. Any conflicts that arise between the two researchers at this initial screening stage will be resolved by discussion and by consulting a third member of the research team to reach a final decision if necessary. Sources of data that received a yes vote from both researchers and are deemed potentially relevant based on the initial assessments made by researchers after examining the titles and abstracts will be retrieved in their full-text version. The full-text versions of potential studies for inclusion will be read and again, be assessed against the inclusion criteria by two researchers independently. The researchers will have the option in Covidence to include or exclude publications at this stage. If the researchers vote to exclude any publication, they will be prompted to select a reason for exclusion. This decision-making process will be documented and reported in the scoping review and also displayed in a PRISMA flowchart. The researchers will then be guided to the consensus process. The consensus screen in Covidence highlights the number of conflicts between the two researchers and allows a final decision to be reached in relation to the inclusion of publications. In the event that any disagreement between the two members of the research team assessing the studies for inclusion in the scoping review arises, a third member of the research team will be consulted, and their input will be used to resolve such conflicts of opinions. In line with the JBI guidelines ( Peters et al. , 2020 ), a PRISMA flowchart of the review process will be developed and included in the review. This flowchart will detail the full flow of the review process from the initial search to the presentation of included sources. Data extraction The data extraction method for this scoping review will firstly involve the development of a data extraction template. As previously mentioned, the data will be extracted from the publications selected for inclusion in the scoping review within Covidence. The key information that will be extracted will include the following: name of author(s), year of publication, geographical location of study, aim of the study, methodology and key findings that relate to the research question. The data extraction method will be piloted and trialled on two or three sources to ensure that all relevant data is extracted. After this step, the extraction template will be updated to ensure that it is an appropriate method of collecting all necessary data. The piloting of the template will be carried out by two members of the research team as recommended by Peters et al. (2020) . Once these data have been extracted, they will be exported to Microsoft Excel. Data analysis and presentation In line with the JBI methodological framework for scoping reviews, the extracted data will be arranged into a charting table in order to provide the reviewers and readers with a clear and descriptive summary of the publications included in the scoping review ( Peters et al. , 2020 ). According to Peters et al. (2020) , the data charting can be an iterative process and therefore, the charting tool will be piloted, and the table will be continuously updated. The results of this scoping review will be mapped descriptively in order to answer the research question. A narrative account of the included literature will be presented. A numerical summary of the literature will be presented in addition to a qualitative content analysis of the studies included in the scoping review. Both the numerical summary and qualitative content analysis will be of a descriptive nature as the aim of a scoping review is to present an overview of the literature reviewed rather than an assessment of the quality of the included materials ( Arksey & O’Malley, 2005 ; Peters et al. , 2020 ). The descriptive numerical summary will include information such as the overall number of publications that have been included, the years of publication, the geographical location where the studies were conducted, and the types of study designs used. The qualitative content analysis will answer the research question by providing a description of the results of each of the included studies. The data extracted from the included studies will be presented in a tabular and descriptive format. Considering the implications of the findings produced by a scoping review has been highlighted as an important part of the scoping review methodological framework ( Levac et al. , 2010 ). Given that this is viewed as an essential element of conducting a scoping review, the implications of the results of this scoping review will be considered in relation to the identification of research gaps or calls for further research in the area. Study status The scoping review is currently in the preliminary stages of searching the databases. Step 1 of the three-step search strategy, as outlined by Peters et al. (2020) for identifying and collating sources of evidence to inform the scoping review, is currently underway. An initial search of databases for potentially relevant sources of evidence is being performed. Conclusions This protocol provides the structure for the conduction of a review to identify and chart the evidence of validation studies of rates of adverse events in administrative data. In line with the JBI guidelines ( Peters et al. , 2020 ), any deviations of the scoping review from the protocol will be acknowledged and discussed in the scoping review. It is widely acknowledged that administrative data have the potential to enhance patient safety and be used as a quality indicator however, given that the rates of adverse events in these datasets have been frequently reported as inaccurate, there is a strong rationale to conduct this scoping review. This review will aim to present an overview of the chart review approaches and tools that have been used to validate rates of AEs in administrative datasets and ultimately highlighting the need to develop a systematic approach to measuring rates of AEs in administrative data. This will allow the accuracy of these datasets to be improved, which will enable researchers and policy makers to use them to their full potential to improve patient safety and healthcare quality. Data availability No data are associated with this article. 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Grant information Health Research Board [ILP-HSR-2022-009]. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Article Versions (2) version 2 Revised Published: 12 Dec 2024, 6:21 https://doi.org/10.12688/hrbopenres.13706.2 version 1 Published: 23 Mar 2023, 6:21 https://doi.org/10.12688/hrbopenres.13706.1 Copyright © 2024 Connolly A et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics VIEWS $counts.viewCount downloads Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Connolly A, Kirwan M and Matthews A. Validation of the rates of adverse event incidence in administrative healthcare data through patient chart review: A scoping review protocol [version 2; peer review: 2 approved, 1 approved with reservations] . HRB Open Res 2024, 6 :21 ( https://doi.org/10.12688/hrbopenres.13706.2 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Version 2 VERSION 2 PUBLISHED 12 Dec 2024 Revised Views 0 Cite How to cite this report: Sittig DF. Reviewer Report For: Validation of the rates of adverse event incidence in administrative healthcare data through patient chart review: A scoping review protocol [version 2; peer review: 2 approved, 1 approved with reservations] . HRB Open Res 2024, 6 :21 ( https://doi.org/10.21956/hrbopenres.15420.r44294 ) The direct URL for this report is: https://hrbopenresearch.org/articles/6-21/v2#referee-response-44294 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 16 Jan 2025 Dean F Sittig , University of Texas Health Science Center at Houston, Houston, TX, USA Approved with Reservations VIEWS 0 https://doi.org/10.21956/hrbopenres.15420.r44294 Your Report Overall Important scoping review about validating adverse event incidence through chart reviews. The introduction and conclusion need to be revised. The JBI methodology is followed correctly. The paper should be revised and resubmitted for ... Continue reading READ ALL Your Report Overall Important scoping review about validating adverse event incidence through chart reviews. The introduction and conclusion need to be revised. The JBI methodology is followed correctly. The paper should be revised and resubmitted for further consideration. In general, someone, either the authors or the editors of the journal need to take responsibility for making sure that there a no errors in the manuscript. Currently, there are typos, duplications, and words that don’t make sense. Abstract Background – clearly state objective of scoping review and scoping review question. Methods – What is Covidence? Maybe mention a software was used and then elaborate the use of Covidence in the methods section in body of the manuscript. Manuscript Introduction/Background – Multiple typos (for example: in the 3 rd paragraph: patient’s stay needs a space in between, include “the” in front of hospital). A proofread is needed once more to check for grammar and spelling errors. Evidently?, patient safety is a key healthcare…remove evidently Para 2: administrative data contain some patient characteristics like age, gender, but are most often de-identified as much as possible. This should be mentioned. Mention ICD is available in multiple languages Weave in 2 nd paragraph into the 5 th paragraph to make it more concise. Overall introduction still contains repetition and can be condensed further. Clearly state objective of scoping review and scoping review question prior to introducing inclusion sub-heading. Pg 4 last para – The HMPS method is a two-stage is written 2x. this paper requires significant proof-reading before it can be published. Pg 5: population section missing period at end of sentence ..administrative data Hospital-based… Population para is overly redundant and duplicative. Consider 1 good sentence to say you are focused on hospital patients. Context para: first sentence should be removed. It is duplicative of concept section. Types of evidence open? I think you should at least limit to published studies in English (unless you can read other languages) of adults (or will you include children, if so, say that). I think peer-reviewed literature seems like a reasonable limit at well. Table 1 is not very useful. The exclusion criteria seem to be simply the opposite of the inclusion criteria. That is a given. I think the exclusion should be like: No children will be included in the study; no rehab hospitals’ data will be included, etc. Also, exclusion sources of evidence published after 2023, apparently. Which I would at least move to the end of 2024, now. Conclusion – Citation is needed for “rates of AE have been frequently reported as inaccurate”. Need to mention similar or previous studies in this area to differentiate what this paper is adding to the field. Ethics approval or waiver statement is needed. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Sittig DF. Reviewer Report For: Validation of the rates of adverse event incidence in administrative healthcare data through patient chart review: A scoping review protocol [version 2; peer review: 2 approved, 1 approved with reservations] . HRB Open Res 2024, 6 :21 ( https://doi.org/10.21956/hrbopenres.15420.r44294 ) The direct URL for this report is: https://hrbopenresearch.org/articles/6-21/v2#referee-response-44294 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Marsolo K. Reviewer Report For: Validation of the rates of adverse event incidence in administrative healthcare data through patient chart review: A scoping review protocol [version 2; peer review: 2 approved, 1 approved with reservations] . HRB Open Res 2024, 6 :21 ( https://doi.org/10.21956/hrbopenres.15420.r44039 ) The direct URL for this report is: https://hrbopenresearch.org/articles/6-21/v2#referee-response-44039 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 28 Dec 2024 Keith Marsolo , Duke University School of Medicine, Durham, NC, USA Approved VIEWS 0 https://doi.org/10.21956/hrbopenres.15420.r44039 The authors have made sufficient revisions to ... Continue reading READ ALL The authors have made sufficient revisions to address the concerns raised in my review. Competing Interests: No competing interests were disclosed. Reviewer Expertise: informatics, real-world data research. I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Marsolo K. Reviewer Report For: Validation of the rates of adverse event incidence in administrative healthcare data through patient chart review: A scoping review protocol [version 2; peer review: 2 approved, 1 approved with reservations] . HRB Open Res 2024, 6 :21 ( https://doi.org/10.21956/hrbopenres.15420.r44039 ) The direct URL for this report is: https://hrbopenresearch.org/articles/6-21/v2#referee-response-44039 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Version 1 VERSION 1 PUBLISHED 23 Mar 2023 Views 0 Cite How to cite this report: Flynn A. Reviewer Report For: Validation of the rates of adverse event incidence in administrative healthcare data through patient chart review: A scoping review protocol [version 2; peer review: 2 approved, 1 approved with reservations] . HRB Open Res 2024, 6 :21 ( https://doi.org/10.21956/hrbopenres.14991.r36413 ) The direct URL for this report is: https://hrbopenresearch.org/articles/6-21/v1#referee-response-36413 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 14 Nov 2023 Angela Flynn , University College Cork, Cork, County Cork, Ireland Approved VIEWS 0 https://doi.org/10.21956/hrbopenres.14991.r36413 This is a very interesting protocol for a necessary scoping review. The authors have clearly identified the importance of the accuracy and validity of important healthcare incident data in the inpatient clinical setting. I was uncertain as ... Continue reading READ ALL This is a very interesting protocol for a necessary scoping review. The authors have clearly identified the importance of the accuracy and validity of important healthcare incident data in the inpatient clinical setting. I was uncertain as to what precisely was meant by "administrative healthcare data" and, as has been mentioned by another reviewer, I wondered whether there may be other sources to include - such as electronic health record. The universality of this data is very well explained however, while specific diagnoses are globally understood via the ICD classification the adverse incidents may not yet have such a universal understanding. This scoping review aims to work towards that goal. It may be worth emphasising further how the ultimate goal might be to in fact prevent and anticipate adverse incidents and improve quality of care. You mention a number of potential benefits of this work but I wondered whether it might be worthwhile pointing out the capacity to link this data with staffing information to demonstrate the impact of safe/unsafe staffing. In the context of a global nursing and health professional shortage, it is a point worth making. In terms of other detail, the introduction seems a little too long. The sentence beginning "Whilst the inaccuracy of..." needs to be reworded. The detail around various methods of chart reviewing seems excessive. Population - the sentence "This population is of..." needs attention. Concept - the last two sentences in this seem repetitive. Study Selection - this piece is good but you might just clarify in one line how many researchers will review each paper for the inclusion/exclusion decision - is it one or two? Otherwise an interesting protocol and I look forward to reading the review results. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: Nursing, Health inequities, Inclusion Health I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Flynn A. Reviewer Report For: Validation of the rates of adverse event incidence in administrative healthcare data through patient chart review: A scoping review protocol [version 2; peer review: 2 approved, 1 approved with reservations] . HRB Open Res 2024, 6 :21 ( https://doi.org/10.21956/hrbopenres.14991.r36413 ) The direct URL for this report is: https://hrbopenresearch.org/articles/6-21/v1#referee-response-36413 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Author Response 12 Dec 2024 Anna Connolly , School of Nursing, Psychotherapy and Community Health, Dublin City University, Dublin, Ireland 12 Dec 2024 Author Response We would like to thank the reviewer for their support of our work and constructive feedback on our manuscript. We have amended the manuscript to provide further clarity on ... Continue reading We would like to thank the reviewer for their support of our work and constructive feedback on our manuscript. We have amended the manuscript to provide further clarity on what is meant by administrative healthcare data and included a mention of electronic heath records as another source from which administrative data can be generated. We have also amended the manuscript to place further emphasis on the prevention of adverse events and the improvement of quality care as the ultimate goal of validating administrative datasets and ensuring their accuracy. Furthermore, the potential benefit of this work to highlight the capacity of linking accurate administrative data with staffing information to demonstrate the impact of safe/unsafe staffing has also been addressed in the revised manuscript. On review of the manuscript, we have reduced the introduction section and provided a more concise overview of the chart review methodologies. Also, in light of the comments, we have amended the population and concept sections in the manuscript. Finally, the manuscript has also been amended to provide a clearer description of the number of researchers involved in the reviewing of the papers for inclusion or exclusion. Two researchers each individually reviewed papers for inclusion/exclusion. The scoping review has since been completed and published in the International Journal for Quality in Health Care and is available at: https://academic.oup.com/intqhc/article/36/2/mzae037/7658312?searchresult=1. Thank you again for your comments, feedback and support of this research. We would like to thank the reviewer for their support of our work and constructive feedback on our manuscript. We have amended the manuscript to provide further clarity on what is meant by administrative healthcare data and included a mention of electronic heath records as another source from which administrative data can be generated. We have also amended the manuscript to place further emphasis on the prevention of adverse events and the improvement of quality care as the ultimate goal of validating administrative datasets and ensuring their accuracy. Furthermore, the potential benefit of this work to highlight the capacity of linking accurate administrative data with staffing information to demonstrate the impact of safe/unsafe staffing has also been addressed in the revised manuscript. On review of the manuscript, we have reduced the introduction section and provided a more concise overview of the chart review methodologies. Also, in light of the comments, we have amended the population and concept sections in the manuscript. Finally, the manuscript has also been amended to provide a clearer description of the number of researchers involved in the reviewing of the papers for inclusion or exclusion. Two researchers each individually reviewed papers for inclusion/exclusion. The scoping review has since been completed and published in the International Journal for Quality in Health Care and is available at: https://academic.oup.com/intqhc/article/36/2/mzae037/7658312?searchresult=1. Thank you again for your comments, feedback and support of this research. Competing Interests: No competing interests were disclosed. Close Report a concern Respond or Comment COMMENTS ON THIS REPORT Author Response 12 Dec 2024 Anna Connolly , School of Nursing, Psychotherapy and Community Health, Dublin City University, Dublin, Ireland 12 Dec 2024 Author Response We would like to thank the reviewer for their support of our work and constructive feedback on our manuscript. We have amended the manuscript to provide further clarity on ... Continue reading We would like to thank the reviewer for their support of our work and constructive feedback on our manuscript. We have amended the manuscript to provide further clarity on what is meant by administrative healthcare data and included a mention of electronic heath records as another source from which administrative data can be generated. We have also amended the manuscript to place further emphasis on the prevention of adverse events and the improvement of quality care as the ultimate goal of validating administrative datasets and ensuring their accuracy. Furthermore, the potential benefit of this work to highlight the capacity of linking accurate administrative data with staffing information to demonstrate the impact of safe/unsafe staffing has also been addressed in the revised manuscript. On review of the manuscript, we have reduced the introduction section and provided a more concise overview of the chart review methodologies. Also, in light of the comments, we have amended the population and concept sections in the manuscript. Finally, the manuscript has also been amended to provide a clearer description of the number of researchers involved in the reviewing of the papers for inclusion or exclusion. Two researchers each individually reviewed papers for inclusion/exclusion. The scoping review has since been completed and published in the International Journal for Quality in Health Care and is available at: https://academic.oup.com/intqhc/article/36/2/mzae037/7658312?searchresult=1. Thank you again for your comments, feedback and support of this research. We would like to thank the reviewer for their support of our work and constructive feedback on our manuscript. We have amended the manuscript to provide further clarity on what is meant by administrative healthcare data and included a mention of electronic heath records as another source from which administrative data can be generated. We have also amended the manuscript to place further emphasis on the prevention of adverse events and the improvement of quality care as the ultimate goal of validating administrative datasets and ensuring their accuracy. Furthermore, the potential benefit of this work to highlight the capacity of linking accurate administrative data with staffing information to demonstrate the impact of safe/unsafe staffing has also been addressed in the revised manuscript. On review of the manuscript, we have reduced the introduction section and provided a more concise overview of the chart review methodologies. Also, in light of the comments, we have amended the population and concept sections in the manuscript. Finally, the manuscript has also been amended to provide a clearer description of the number of researchers involved in the reviewing of the papers for inclusion or exclusion. Two researchers each individually reviewed papers for inclusion/exclusion. The scoping review has since been completed and published in the International Journal for Quality in Health Care and is available at: https://academic.oup.com/intqhc/article/36/2/mzae037/7658312?searchresult=1. Thank you again for your comments, feedback and support of this research. Competing Interests: No competing interests were disclosed. Close Report a concern COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Marsolo K. Reviewer Report For: Validation of the rates of adverse event incidence in administrative healthcare data through patient chart review: A scoping review protocol [version 2; peer review: 2 approved, 1 approved with reservations] . HRB Open Res 2024, 6 :21 ( https://doi.org/10.21956/hrbopenres.14991.r36049 ) The direct URL for this report is: https://hrbopenresearch.org/articles/6-21/v1#referee-response-36049 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 27 Sep 2023 Keith Marsolo , Duke University School of Medicine, Durham, NC, USA Approved with Reservations VIEWS 0 https://doi.org/10.21956/hrbopenres.14991.r36049 This protocol describes a scoping review related to adverse events obtained from administrative data, particularly related to methods of validation for adverse event detection. The methods are generally good, though the proposed search terms are likely to miss many potential ... Continue reading READ ALL This protocol describes a scoping review related to adverse events obtained from administrative data, particularly related to methods of validation for adverse event detection. The methods are generally good, though the proposed search terms are likely to miss many potential publications, at least from the United States (US). The protocol makes frequent use of the term "administrative data," though that is not routinely used in many fields. In the US, for instance, "administrative claims data" is used to refer to information available from insurance companies or health plans. In contrast, data available from health systems is often simply called "electronic health record" or EHR data. This protocol is mostly about identifying articles that describe validation of adverse event detection method, which implies that the authors are interested in EHR data. However, the search terms may be more likely to bring back articles related to administrative claims. Claims data are often used in health services research, and US initiatives like FDA's Sentinel will often look for adverse events within these datasets, but those adverse events are not necessarily the same ones that occur within a hospital setting. I would recommend revisiting the search terms and include reference to EHR datasets. In adddition, there is a fair amount of redundant text in the Introduction (for instance, 2 nd paragraph and initial sentences of paragraphs 3 and 5). If this text is intended to be used in a subsequent publication, it should be condensed. Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: informatics, real-world data research. I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Marsolo K. Reviewer Report For: Validation of the rates of adverse event incidence in administrative healthcare data through patient chart review: A scoping review protocol [version 2; peer review: 2 approved, 1 approved with reservations] . HRB Open Res 2024, 6 :21 ( https://doi.org/10.21956/hrbopenres.14991.r36049 ) The direct URL for this report is: https://hrbopenresearch.org/articles/6-21/v1#referee-response-36049 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Author Response 12 Dec 2024 Anna Connolly , School of Nursing, Psychotherapy and Community Health, Dublin City University, Dublin, Ireland 12 Dec 2024 Author Response We would like to thank the reviewer for their support of our work and constructive feedback on our manuscript. We appreciate and have considered the feedback in relation to ... Continue reading We would like to thank the reviewer for their support of our work and constructive feedback on our manuscript. We appreciate and have considered the feedback in relation to the inclusion of reference to electronic health records in the search strategy terms for the identification of publications for inclusion in this review. The manuscript has been amended to reflect the electronic health record as a source from which administrative data can be derived. This review intended to provide an overview of the chart review methods used to validate coded data such as those in administrative datasets rather than validating electronic health record data itself, hence why reference to EHR datasets alone was not included in the search terms. Furthermore, on preliminary searches using the search terms published in this protocol, many of the results pertained to studies that took place in the US therefore, we believe that the developed search strategy is sufficient for identifying relevant research articles. Also, the text in the opening section has been reduced to provide a more concise introduction to the protocol. The scoping review has since been completed and published in the International Journal for Quality in Health Care and is available at: https://academic.oup.com/intqhc/article/36/2/mzae037/7658312?searchresult=1. Thank you again for your comments, feedback and support of this research. We would like to thank the reviewer for their support of our work and constructive feedback on our manuscript. We appreciate and have considered the feedback in relation to the inclusion of reference to electronic health records in the search strategy terms for the identification of publications for inclusion in this review. The manuscript has been amended to reflect the electronic health record as a source from which administrative data can be derived. This review intended to provide an overview of the chart review methods used to validate coded data such as those in administrative datasets rather than validating electronic health record data itself, hence why reference to EHR datasets alone was not included in the search terms. Furthermore, on preliminary searches using the search terms published in this protocol, many of the results pertained to studies that took place in the US therefore, we believe that the developed search strategy is sufficient for identifying relevant research articles. Also, the text in the opening section has been reduced to provide a more concise introduction to the protocol. The scoping review has since been completed and published in the International Journal for Quality in Health Care and is available at: https://academic.oup.com/intqhc/article/36/2/mzae037/7658312?searchresult=1. Thank you again for your comments, feedback and support of this research. Competing Interests: No competing interests were disclosed. Close Report a concern Respond or Comment COMMENTS ON THIS REPORT Author Response 12 Dec 2024 Anna Connolly , School of Nursing, Psychotherapy and Community Health, Dublin City University, Dublin, Ireland 12 Dec 2024 Author Response We would like to thank the reviewer for their support of our work and constructive feedback on our manuscript. We appreciate and have considered the feedback in relation to ... Continue reading We would like to thank the reviewer for their support of our work and constructive feedback on our manuscript. We appreciate and have considered the feedback in relation to the inclusion of reference to electronic health records in the search strategy terms for the identification of publications for inclusion in this review. The manuscript has been amended to reflect the electronic health record as a source from which administrative data can be derived. This review intended to provide an overview of the chart review methods used to validate coded data such as those in administrative datasets rather than validating electronic health record data itself, hence why reference to EHR datasets alone was not included in the search terms. Furthermore, on preliminary searches using the search terms published in this protocol, many of the results pertained to studies that took place in the US therefore, we believe that the developed search strategy is sufficient for identifying relevant research articles. Also, the text in the opening section has been reduced to provide a more concise introduction to the protocol. The scoping review has since been completed and published in the International Journal for Quality in Health Care and is available at: https://academic.oup.com/intqhc/article/36/2/mzae037/7658312?searchresult=1. Thank you again for your comments, feedback and support of this research. We would like to thank the reviewer for their support of our work and constructive feedback on our manuscript. We appreciate and have considered the feedback in relation to the inclusion of reference to electronic health records in the search strategy terms for the identification of publications for inclusion in this review. The manuscript has been amended to reflect the electronic health record as a source from which administrative data can be derived. This review intended to provide an overview of the chart review methods used to validate coded data such as those in administrative datasets rather than validating electronic health record data itself, hence why reference to EHR datasets alone was not included in the search terms. Furthermore, on preliminary searches using the search terms published in this protocol, many of the results pertained to studies that took place in the US therefore, we believe that the developed search strategy is sufficient for identifying relevant research articles. Also, the text in the opening section has been reduced to provide a more concise introduction to the protocol. The scoping review has since been completed and published in the International Journal for Quality in Health Care and is available at: https://academic.oup.com/intqhc/article/36/2/mzae037/7658312?searchresult=1. Thank you again for your comments, feedback and support of this research. Competing Interests: No competing interests were disclosed. Close Report a concern COMMENT ON THIS REPORT Comments on this article Comments (0) Version 2 VERSION 2 PUBLISHED 23 Mar 2023 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 2 3 Version 2 (revision) 12 Dec 24 read read Version 1 23 Mar 23 read read Keith Marsolo , Duke University School of Medicine, Durham, NC, USA Angela Flynn , University College Cork, Cork, Ireland Dean F Sittig , University of Texas Health Science Center at Houston, Houston, USA Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Sittig D. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 16 Jan 2025 | for Version 2 Dean F Sittig , University of Texas Health Science Center at Houston, Houston, TX, USA 0 Views copyright © 2025 Sittig D. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Your Report Overall Important scoping review about validating adverse event incidence through chart reviews. The introduction and conclusion need to be revised. The JBI methodology is followed correctly. The paper should be revised and resubmitted for further consideration. In general, someone, either the authors or the editors of the journal need to take responsibility for making sure that there a no errors in the manuscript. Currently, there are typos, duplications, and words that don’t make sense. Abstract Background – clearly state objective of scoping review and scoping review question. Methods – What is Covidence? Maybe mention a software was used and then elaborate the use of Covidence in the methods section in body of the manuscript. Manuscript Introduction/Background – Multiple typos (for example: in the 3 rd paragraph: patient’s stay needs a space in between, include “the” in front of hospital). A proofread is needed once more to check for grammar and spelling errors. Evidently?, patient safety is a key healthcare…remove evidently Para 2: administrative data contain some patient characteristics like age, gender, but are most often de-identified as much as possible. This should be mentioned. Mention ICD is available in multiple languages Weave in 2 nd paragraph into the 5 th paragraph to make it more concise. Overall introduction still contains repetition and can be condensed further. Clearly state objective of scoping review and scoping review question prior to introducing inclusion sub-heading. Pg 4 last para – The HMPS method is a two-stage is written 2x. this paper requires significant proof-reading before it can be published. Pg 5: population section missing period at end of sentence ..administrative data Hospital-based… Population para is overly redundant and duplicative. Consider 1 good sentence to say you are focused on hospital patients. Context para: first sentence should be removed. It is duplicative of concept section. Types of evidence open? I think you should at least limit to published studies in English (unless you can read other languages) of adults (or will you include children, if so, say that). I think peer-reviewed literature seems like a reasonable limit at well. Table 1 is not very useful. The exclusion criteria seem to be simply the opposite of the inclusion criteria. That is a given. I think the exclusion should be like: No children will be included in the study; no rehab hospitals’ data will be included, etc. Also, exclusion sources of evidence published after 2023, apparently. Which I would at least move to the end of 2024, now. Conclusion – Citation is needed for “rates of AE have been frequently reported as inaccurate”. Need to mention similar or previous studies in this area to differentiate what this paper is adding to the field. Ethics approval or waiver statement is needed. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests No competing interests were disclosed. I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (0) Sittig DF. Peer Review Report For: Validation of the rates of adverse event incidence in administrative healthcare data through patient chart review: A scoping review protocol [version 2; peer review: 2 approved, 1 approved with reservations] . HRB Open Res 2024, 6 :21 ( https://doi.org/10.21956/hrbopenres.15420.r44294) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://hrbopenresearch.org/articles/6-21/v2#referee-response-44294 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Marsolo K. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 28 Dec 2024 | for Version 2 Keith Marsolo , Duke University School of Medicine, Durham, NC, USA 0 Views copyright © 2024 Marsolo K. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions The authors have made sufficient revisions to address the concerns raised in my review. Competing Interests No competing interests were disclosed. Reviewer Expertise informatics, real-world data research. I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. reply Respond to this report Responses (0) Marsolo K. Peer Review Report For: Validation of the rates of adverse event incidence in administrative healthcare data through patient chart review: A scoping review protocol [version 2; peer review: 2 approved, 1 approved with reservations] . HRB Open Res 2024, 6 :21 ( https://doi.org/10.21956/hrbopenres.15420.r44039) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://hrbopenresearch.org/articles/6-21/v2#referee-response-44039 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2023 Flynn A. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 14 Nov 2023 | for Version 1 Angela Flynn , University College Cork, Cork, County Cork, Ireland 0 Views copyright © 2023 Flynn A. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (1) Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions This is a very interesting protocol for a necessary scoping review. The authors have clearly identified the importance of the accuracy and validity of important healthcare incident data in the inpatient clinical setting. I was uncertain as to what precisely was meant by "administrative healthcare data" and, as has been mentioned by another reviewer, I wondered whether there may be other sources to include - such as electronic health record. The universality of this data is very well explained however, while specific diagnoses are globally understood via the ICD classification the adverse incidents may not yet have such a universal understanding. This scoping review aims to work towards that goal. It may be worth emphasising further how the ultimate goal might be to in fact prevent and anticipate adverse incidents and improve quality of care. You mention a number of potential benefits of this work but I wondered whether it might be worthwhile pointing out the capacity to link this data with staffing information to demonstrate the impact of safe/unsafe staffing. In the context of a global nursing and health professional shortage, it is a point worth making. In terms of other detail, the introduction seems a little too long. The sentence beginning "Whilst the inaccuracy of..." needs to be reworded. The detail around various methods of chart reviewing seems excessive. Population - the sentence "This population is of..." needs attention. Concept - the last two sentences in this seem repetitive. Study Selection - this piece is good but you might just clarify in one line how many researchers will review each paper for the inclusion/exclusion decision - is it one or two? Otherwise an interesting protocol and I look forward to reading the review results. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests No competing interests were disclosed. Reviewer Expertise Nursing, Health inequities, Inclusion Health I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. reply Respond to this report Responses (1) Author Response 12 Dec 2024 Anna Connolly, School of Nursing, Psychotherapy and Community Health, Dublin City University, Dublin, Ireland We would like to thank the reviewer for their support of our work and constructive feedback on our manuscript. We have amended the manuscript to provide further clarity on what is meant by administrative healthcare data and included a mention of electronic heath records as another source from which administrative data can be generated. We have also amended the manuscript to place further emphasis on the prevention of adverse events and the improvement of quality care as the ultimate goal of validating administrative datasets and ensuring their accuracy. Furthermore, the potential benefit of this work to highlight the capacity of linking accurate administrative data with staffing information to demonstrate the impact of safe/unsafe staffing has also been addressed in the revised manuscript. On review of the manuscript, we have reduced the introduction section and provided a more concise overview of the chart review methodologies. Also, in light of the comments, we have amended the population and concept sections in the manuscript. Finally, the manuscript has also been amended to provide a clearer description of the number of researchers involved in the reviewing of the papers for inclusion or exclusion. Two researchers each individually reviewed papers for inclusion/exclusion. The scoping review has since been completed and published in the International Journal for Quality in Health Care and is available at: https://academic.oup.com/intqhc/article/36/2/mzae037/7658312?searchresult=1. Thank you again for your comments, feedback and support of this research. View more View less Competing Interests No competing interests were disclosed. reply Respond Report a concern Flynn A. Peer Review Report For: Validation of the rates of adverse event incidence in administrative healthcare data through patient chart review: A scoping review protocol [version 2; peer review: 2 approved, 1 approved with reservations] . HRB Open Res 2024, 6 :21 ( https://doi.org/10.21956/hrbopenres.14991.r36413) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://hrbopenresearch.org/articles/6-21/v1#referee-response-36413 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2023 Marsolo K. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 27 Sep 2023 | for Version 1 Keith Marsolo , Duke University School of Medicine, Durham, NC, USA 0 Views copyright © 2023 Marsolo K. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (1) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions This protocol describes a scoping review related to adverse events obtained from administrative data, particularly related to methods of validation for adverse event detection. The methods are generally good, though the proposed search terms are likely to miss many potential publications, at least from the United States (US). The protocol makes frequent use of the term "administrative data," though that is not routinely used in many fields. In the US, for instance, "administrative claims data" is used to refer to information available from insurance companies or health plans. In contrast, data available from health systems is often simply called "electronic health record" or EHR data. This protocol is mostly about identifying articles that describe validation of adverse event detection method, which implies that the authors are interested in EHR data. However, the search terms may be more likely to bring back articles related to administrative claims. Claims data are often used in health services research, and US initiatives like FDA's Sentinel will often look for adverse events within these datasets, but those adverse events are not necessarily the same ones that occur within a hospital setting. I would recommend revisiting the search terms and include reference to EHR datasets. In adddition, there is a fair amount of redundant text in the Introduction (for instance, 2 nd paragraph and initial sentences of paragraphs 3 and 5). If this text is intended to be used in a subsequent publication, it should be condensed. Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests No competing interests were disclosed. Reviewer Expertise informatics, real-world data research. I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (1) Author Response 12 Dec 2024 Anna Connolly, School of Nursing, Psychotherapy and Community Health, Dublin City University, Dublin, Ireland We would like to thank the reviewer for their support of our work and constructive feedback on our manuscript. We appreciate and have considered the feedback in relation to the inclusion of reference to electronic health records in the search strategy terms for the identification of publications for inclusion in this review. The manuscript has been amended to reflect the electronic health record as a source from which administrative data can be derived. This review intended to provide an overview of the chart review methods used to validate coded data such as those in administrative datasets rather than validating electronic health record data itself, hence why reference to EHR datasets alone was not included in the search terms. Furthermore, on preliminary searches using the search terms published in this protocol, many of the results pertained to studies that took place in the US therefore, we believe that the developed search strategy is sufficient for identifying relevant research articles. Also, the text in the opening section has been reduced to provide a more concise introduction to the protocol. The scoping review has since been completed and published in the International Journal for Quality in Health Care and is available at: https://academic.oup.com/intqhc/article/36/2/mzae037/7658312?searchresult=1. Thank you again for your comments, feedback and support of this research. View more View less Competing Interests No competing interests were disclosed. reply Respond Report a concern Marsolo K. Peer Review Report For: Validation of the rates of adverse event incidence in administrative healthcare data through patient chart review: A scoping review protocol [version 2; peer review: 2 approved, 1 approved with reservations] . HRB Open Res 2024, 6 :21 ( https://doi.org/10.21956/hrbopenres.14991.r36049) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. 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