David Budgen

Context: Several tertiary studies have criticized the reporting of software engineering secondary studies. Objective: Our objective is to identify guidelines for reporting software engineering (SE) secondary studies which would address problems observed in the reporting of software engineering systematic reviews (SRs). Method: We review the criticisms of SE secondary studies and identify the major areas of concern. We assess the PRISMA 2020 (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement as a possible solution to the need for SR reporting guidelines, based on its status as the reporting guideline recommended by the Cochrane Collaboration whose SR guidelines were a major input to the guidelines developed for SE. We report its advantages and limitations in the context of SE secondary studies. We also assess reporting guidelines for mapping studies and qualitative reviews, and compare their structure and content with that of PRISMA 2020. Results: Previous tertiary studies confirm that reports of secondary studies are of variable quality. However, ad hoc recommendations that amend reporting standards may result in unnecessary duplication of text. We confirm that the PRISMA 2020 statement addresses SE reporting problems, but is mainly oriented to quantitative reviews, mixed-methods reviews and meta-analyses. However, we show that the PRISMA 2020 item definitions can be extended to cover the information needed to report mapping studies and qualitative reviews. Conclusions: In this paper and its Supplementary Material, we present and illustrate an integrated set of guidelines called SEGRESS (Software Engineering Guidelines for REporting Secondary Studies), suitable for quantitative systematic reviews (building upon PRISMA 2020), mapping studies (PRISMA-ScR), and qualitative reviews (ENTREQ and RAMESES), that addresses reporting problems found in current SE SRs.

Context:Recent papers have proposed the use of grey literature(GL) and multivocal reviews. These papers have raised issues about the practices used for systematic reviews(SRs) in software engineering(SE) and suggested that there should be changes to the current SR guidelines. Objective: To investigate whether current SR guidelines need to be changed to support GL and multivocal reviews. Method:We discuss the definitions of GL and the importance of GL and of industry-based field studies in SE SRs. We identify properties of SRs that constrain the material used in SRs: a) the nature of primary studies b) the requirements of SRs to be auditable, traceable, and reproducible, and explain why these requirements restrict the use of blogs in SRs. Results:SR guidelines have always considered GL as a possible source of primary studies and never supported excluding field studies that incorporate the practitioners' viewpoint. However, GL which was meant to refer to documents that were not formally published, is now being extended to information from blogs/tweets/Q\&A posts. Thus, it might seem that SRs do not make full use of GL because they do not include such information. However, the unit of analysis in SR is the primary study. Thus, it is not the source but the type of information that is important. Any report describing a rigorous empirical evaluation is a candidate primary study. Whether it is actually included in a SR depends on the SR eligibility criteria. However, any study that cannot be guaranteed to be publicly available in the long term should not be used as a primary study in an SR. This does not prevent such information being aggregated in surveys of social media and used in the context of evidence-based software engineering(EBSE). Conclusions:Current guidelines for SRs do not require extensions, but their scope needs to be better defined. SE researchers require guidelines for analysing social media posts (e.g.,blogs, tweets, vlogs), but these should be based on qualitative primary (not secondary) study guidelines. SE researchers can use mixed-methods SRs and/or the fourth step of EBSE to incorporate findings from social media surveys with those from SRs and to develop industry-relevant recommendations.

Background: Data science offers an unparalleled opportunity to identify new insights into many aspects of human life with recent advances in health care. Using data science in digital health raises significant challenges regarding data privacy, transparency, and trustworthiness. Recent regulations enforce the need for a clear legal basis for collecting, processing, and sharing data, for example, the European Union’s General Data Protection Regulation (2016) and the United Kingdom’s Data Protection Act (2018). For health care providers, legal use of the electronic health record (EHR) is permitted only in clinical care cases. Any other use of the data requires thoughtful considerations of the legal context and direct patient consent. Identifiable personal and sensitive information must be sufficiently anonymized. Raw data are commonly anonymized to be used for research purposes, with risk assessment for reidentification and utility. Although health care organizations have internal policies defined for information governance, there is a significant lack of practical tools and intuitive guidance about the use of data for research and modeling. Off-the-shelf data anonymization tools are developed frequently, but privacy-related functionalities are often incomparable with regard to use in different problem domains. In addition, tools to support measuring the risk of the anonymized data with regard to reidentification against the usefulness of the data exist, but there are question marks over their efficacy.Objective: In this systematic literature mapping study, we aim to alleviate the aforementioned issues by reviewing the landscape of data anonymization for digital health care.Methods: We used Google Scholar, Web of Science, Elsevier Scopus, and PubMed to retrieve academic studies published in English up to June 2020. Noteworthy gray literature was also used to initialize the search. We focused on review questions covering 5 bottom-up aspects: basic anonymization operations, privacy models, reidentification risk and usability metrics, off-the-shelf anonymization tools, and the lawful basis for EHR data anonymization.Results: We identified 239 eligible studies, of which 60 were chosen for general background information; 16 were selected for 7 basic anonymization operations; 104 covered 72 conventional and machine learning–based privacy models; four and 19 papers included seven and 15 metrics, respectively, for measuring the reidentification risk and degree of usability; and 36 explored 20 data anonymization software tools. In addition, we also evaluated the practical feasibility of performing anonymization on EHR data with reference to their usability in medical decision-making. Furthermore, we summarized the lawful basis for delivering guidance on practical EHR data anonymization.Conclusions: This systematic literature mapping study indicates that anonymization of EHR data is theoretically achievable; yet, it requires more research efforts in practical implementations to balance privacy preservation and usability to ensure more reliable health care applications.

Background: Predicting the risk of glycated hemoglobin (HbA1c) elevation can help identify patients with the potential for developing serious chronic health problems, such as diabetes. Early preventive interventions based upon advanced predictive models using electronic health records data for identifying such patients can ultimately help provide better health outcomes. Objective: Our study investigated the performance of predictive models to forecast HbA1c elevation levels by employing several machine learning models. We also examined the use of patient electronic health record longitudinal data in the performance of the predictive models. Explainable methods were employed to interpret the decisions made by the black box models. Methods: This study employed multiple logistic regression, random forest, support vector machine, and logistic regression models, as well as a deep learning model (multilayer perceptron) to classify patients with normal (<5.7%) and elevated (≥5.7%) levels of HbA1c. We also integrated current visit data with historical (longitudinal) data from previous visits. Explainable machine learning methods were used to interrogate the models and provide an understanding of the reasons behind the decisions made by the models. All models were trained and tested using a large data set from Saudi Arabia with 18,844 unique patient records. Results: The machine learning models achieved promising results for predicting current HbA1c elevation risk. When coupled with longitudinal data, the machine learning models outperformed the multiple logistic regression model used in the comparative study. The multilayer perceptron model achieved an accuracy of 83.22% for the area under receiver operating characteristic curve when used with historical data. All models showed a close level of agreement on the contribution of random blood sugar and age variables with and without longitudinal data. Conclusions: This study shows that machine learning models can provide promising results for the task of predicting current HbA1c levels (≥5.7% or less). Using patients’ longitudinal data improved the performance and affected the relative importance for the predictors used. The models showed results that are consistent with comparable studies.

BACKGROUND Data science offers an unparalleled opportunity to identify new insights into many aspects of human life with recent advances in health care. Using data science in digital health raises significant challenges regarding data privacy, transparency, and trustworthiness. Recent regulations enforce the need for a clear legal basis for collecting, processing, and sharing data, for example, the European Union’s General Data Protection Regulation (2016) and the United Kingdom’s Data Protection Act (2018). For health care providers, legal use of the electronic health record (EHR) is permitted only in clinical care cases. Any other use of the data requires thoughtful considerations of the legal context and direct patient consent. Identifiable personal and sensitive information must be sufficiently anonymized. Raw data are commonly anonymized to be used for research purposes, with risk assessment for reidentification and utility. Although health care organizations have internal policies defined for information governance, there is a significant lack of practical tools and intuitive guidance about the use of data for research and modeling. Off-the-shelf data anonymization tools are developed frequently, but privacy-related functionalities are often incomparable with regard to use in different problem domains. In addition, tools to support measuring the risk of the anonymized data with regard to reidentification against the usefulness of the data exist, but there are question marks over their efficacy. OBJECTIVE In this systematic literature mapping study, we aim to alleviate the aforementioned issues by reviewing the landscape of data anonymization for digital health care. METHODS We used Google Scholar, Web of Science, Elsevier Scopus, and PubMed to retrieve academic studies published in English up to June 2020. Noteworthy gray literature was also used to initialize the search. We focused on review questions covering 5 bottom-up aspects: basic anonymization operations, privacy models, reidentification risk and usability metrics, off-the-shelf anonymization tools, and the lawful basis for EHR data anonymization. RESULTS We identified 239 eligible studies, of which 60 were chosen for general background information; 16 were selected for 7 basic anonymization operations; 104 covered 72 conventional and machine learning–based privacy models; four and 19 papers included seven and 15 metrics, respectively, for measuring the reidentification risk and degree of usability; and 36 explored 20 data anonymization software tools. In addition, we also evaluated the practical feasibility of performing anonymization on EHR data with reference to their usability in medical decision-making. Furthermore, we summarized the lawful basis for delivering guidance on practical EHR data anonymization. CONCLUSIONS This systematic literature mapping study indicates that anonymization of EHR data is theoretically achievable; yet, it requires more research efforts in practical implementations to balance privacy preservation and usability to ensure more reliable health care applications.

Software Design: Creating Solutions for Ill-Structured Problems, Third Edition provides a balanced view of the many and varied software design practices used by practitioners. The book provides a general overview of software design within the context of software development and as a means of addressing ill-structured problems. The third edition has been expanded and reorganised to focus on the structure and process aspects of software design, including architectural issues, as well as design notations and models. It also describes a variety of different ways of creating design solutions such as plan-driven development, agile approaches, patterns, product lines, and other forms. Features •Includes an overview and review of representation forms used for modelling design solutions •Provides a concise review of design practices and how these relate to ideas about software architecture •Uses an evidence-informed basis for discussing design concepts and when their use is appropriate This book is suitable for undergraduate and graduate students taking courses on software engineering and software design, as well as for software engineers. Author David Budgen is a professor emeritus of software engineering at Durham University. His research interests include evidence-based software engineering (EBSE), software design, and healthcare informatics.

BACKGROUND Predicting the risk of glycated hemoglobin (HbA1c) elevation can help identify patients with the potential for developing serious chronic health problems, such as diabetes. Early preventive interventions based upon advanced predictive models using electronic health records data for identifying such patients can ultimately help provide better health outcomes. OBJECTIVE Our study investigated the performance of predictive models to forecast HbA1c elevation levels by employing several machine learning models. We also examined the use of patient electronic health record longitudinal data in the performance of the predictive models. Explainable methods were employed to interpret the decisions made by the black box models. METHODS This study employed multiple logistic regression, random forest, support vector machine, and logistic regression models, as well as a deep learning model (multilayer perceptron) to classify patients with normal (<5.7%) and elevated (≥5.7%) levels of HbA1c. We also integrated current visit data with historical (longitudinal) data from previous visits. Explainable machine learning methods were used to interrogate the models and provide an understanding of the reasons behind the decisions made by the models. All models were trained and tested using a large data set from Saudi Arabia with 18,844 unique patient records. RESULTS The machine learning models achieved promising results for predicting current HbA1c elevation risk. When coupled with longitudinal data, the machine learning models outperformed the multiple logistic regression model used in the comparative study. The multilayer perceptron model achieved an accuracy of 83.22% for the area under receiver operating characteristic curve when used with historical data. All models showed a close level of agreement on the contribution of random blood sugar and age variables with and without longitudinal data. CONCLUSIONS This study shows that machine learning models can provide promising results for the task of predicting current HbA1c levels (≥5.7% or less). Using patients’ longitudinal data improved the performance and affected the relative importance for the predictors used. The models showed results that are consistent with comparable studies.

Background: Electronic health record (EHR) systems generate large datasets that can significantly enrich the development of medical predictive models. Several attempts have been made to investigate the effect of glycated hemoglobin (HbA1c) elevation on the prediction of diabetes onset. However, there is still a need for validation of these models using EHR data collected from different populations. Objective: The aim of this study is to perform a replication study to validate, evaluate, and identify the strengths and weaknesses of replicating a predictive model that employed multiple logistic regression with EHR data to forecast the levels of HbA1c. The original study used data from a population in the United States and this differentiated replication used a population in Saudi Arabia. Methods: A total of 3 models were developed and compared with the model created in the original study. The models were trained and tested using a larger dataset from Saudi Arabia with 36,378 records. The 10-fold cross-validation approach was used for measuring the performance of the models. Results: Applying the method employed in the original study achieved an accuracy of 74% to 75% when using the dataset collected from Saudi Arabia, compared with 77% obtained from using the population from the United States. The results also show a different ranking of importance for the predictors between the original study and the replication. The order of importance for the predictors with our population, from the most to the least importance, is age, random blood sugar, estimated glomerular filtration rate, total cholesterol, non–high-density lipoprotein, and body mass index. Conclusions: This replication study shows that direct use of the models (calculators) created using multiple logistic regression to predict the level of HbA1c may not be appropriate for all populations. This study reveals that the weighting of the predictors needs to be calibrated to the population used. However, the study does confirm that replicating the original study using a different population can help with predicting the levels of HbA1c by using the predictors that are routinely collected and stored in hospital EHR systems.

BACKGROUND Electronic health record (EHR) systems generate large datasets that can significantly enrich the development of medical predictive models. Several attempts have been made to investigate the effect of glycated hemoglobin (HbA1c) elevation on the prediction of diabetes onset. However, there is still a need for validation of these models using EHR data collected from different populations. OBJECTIVE The aim of this study is to perform a replication study to validate, evaluate, and identify the strengths and weaknesses of replicating a predictive model that employed multiple logistic regression with EHR data to forecast the levels of HbA1c. The original study used data from a population in the United States and this differentiated replication used a population in Saudi Arabia. METHODS A total of 3 models were developed and compared with the model created in the original study. The models were trained and tested using a larger dataset from Saudi Arabia with 36,378 records. The 10-fold cross-validation approach was used for measuring the performance of the models. RESULTS Applying the method employed in the original study achieved an accuracy of 74% to 75% when using the dataset collected from Saudi Arabia, compared with 77% obtained from using the population from the United States. The results also show a different ranking of importance for the predictors between the original study and the replication. The order of importance for the predictors with our population, from the most to the least importance, is age, random blood sugar, estimated glomerular filtration rate, total cholesterol, non–high-density lipoprotein, and body mass index. CONCLUSIONS This replication study shows that direct use of the models (calculators) created using multiple logistic regression to predict the level of HbA1c may not be appropriate for all populations. This study reveals that the weighting of the predictors needs to be calibrated to the population used. However, the study does confirm that replicating the original study using a different population can help with predicting the levels of HbA1c by using the predictors that are routinely collected and stored in hospital EHR systems.