Development and Validation of a Health Information System for Assistance and Research in Gestational Trophoblast Disease

doi:10.21203/rs.3.rs-1617863/v1

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Development and Validation of a Health Information System for Assistance and Research in Gestational Trophoblast Disease

https://doi.org/10.21203/rs.3.rs-1617863/v1

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Background: The aim of this work was to develop and validate a Health Information System (HIS) composed of a Web interface for the medical team of the Gestational Trophoblastic Disease (GTD) Outpatient Clinic, as well as a MolaApp Application for patients, as it portrays a interaction between two technological devices with simultaneous application to assist in treatment, reducing time, cost and improving the quality of communication between doctors and patients. Regarding gestational trophoblastic disease, it encompasses all pathological forms of placental trophoblastic tissue proliferation. It is recommended that the patient be followed up by specialists who know the dosage of the hCG curve, in order to diagnose early evolution to a Gestational Trophoblastic Neoplasm (GTN).

Methods: For the development of SIS-Mola, a team was formed with a project manager, a requirements analyst, two programmers and four systems analysts. This is a cross-sectional technological assessment research and the project phases were defined by techniques used by software engineering that covered requirements analysis, programming and development of tools, as well as test and questionnaire applicability. The study was systematized through the intrinsic parameters of care at the GTD Outpatient Clinic.

Results: The tests were carried out from November 2021 to February 2022, with an invitation to 28 eligible participants to proceed with usability and functionality assessments, using a questionnaire based on the System Usability Scale - SUS and an occurrence questionnaire. The responses obtained on the Likert scale indicated excellent reliability and credibility to the HIS. In addition, participants reported high intention to use and recommend digital tools to other Reference Centers in Brazil, suggesting additional improvements.

Conclusion: The HIS, after the final results, proved to meet the essential activities of the Outpatient Clinic specialized in GTD, in the treatment of the disease, because it is technically adequate, practical and easy to handle the tools between its interfaces, as well as for the efficiency for the organization in the flow of the service, in the quality of the assistance provided and in the creation of a database that will allow accurate studies for continued education, professional and scientific improvement.

Gestational trophoblastic disease

Health Technology and Innovation

Software Engineering

Website

Mobile Device

Data Validation

Gestational Trophoblastic Disease (GTD) defines all pathological forms of placental trophoblastic tissue proliferation. Complete hydatidiform mole (MHC) and partial hydatidiform mole (PHM) are classified as benign and invasive mole, choriocarcinoma, placental site trophoblastic tumor and epithelioid trophoblastic tumor are classified as malignant, called Gestational Trophoblastic Neoplasia (GTN) ^{(1, 2)}. It is recommended that both in the initial diagnosis and in the post-molar monitoring, it is of paramount importance that the patient is followed up by specialists who are familiar with the measurement of the human chorionic gonadotropin hormone (hCG) regression curve, the in order to early diagnose the evolution to a GTN with initiation of treatment performed by chemotherapy, in most cases. Thus, when an adequate treatment is carried out, there is a possibility of a high cure rate and the possibility of a healthy pregnancy for the patient⁽³⁾. In this perspective, diagnostic and therapeutic actions for the prevention of diseases and the recovery of health through correct decisions are based on in research, exchange of information and scientific evidence. The application of Information and Communication Technologies (ICTs), considering the quality, safety and efficiency of care, has a significant impact on the provision of health services and changes in the learning process of professionals, establishing a new “doctor-internet-patient” relationship⁽⁴⁾.

As a result of the growth in the practice of digital health and the need for clinical follow-up combined with updated therapeutic approaches, the Ambulatory of Gestational Tropoblastic Diseases, pioneer of this project, by the University Hospital/Hospital São Paulo, Escola Paulista de Medicina, Federal University of São Paulo (HU/HSP/EPM-Unifesp), one of the Reference Centers in Brazil, specialized in treatment, assistance and research, undertook the construction of a HIS composed of two interfaces: a Website (reactive site) for the procedures doctors who, associated with an Application (MolaApp) aimed at patients with the diagnosis, contribute to the teaching-learning binomial⁽⁵⁾. Based on this computerization, even if the access occurs in real time and/or remote, it can help treatments in different geographic regions, promoting a specialized coverage of health care that can be carried out by other Reference Centers in the GTD, existing in Brazil. In this way, the work described the development and evaluation of the usability of a HIS, for academic and assistance purposes. Our motivation in the construction of the HIS was intensified due to the frequent access to computers, tablets and smartphones, as well as the lack of published works that portray the interaction between two technological devices developed with simultaneous application, as tools to help in the treatment process in GTD. In addition, also by reducing time, cost and improving the quality of communication between doctors and patients.

Another important factor regarding the therapeutic resources adopted for the educational assistance of patients, their families and other interested people is the use of social media and digital platforms that enable pedagogical and innovative initiatives in health. Diniz et al.⁽⁶⁾ reports the experience of online interaction, through a Facebook page, between physicians who are directors of the Brazilian Association of Gestational Trophoblastic Disease - ABDTG and patients with hydatidiform mole, in which positive results regarding satisfaction, security and understanding of information and guidance provided remotely.

With the awareness and knowledge of the existence of services with a perspective of improving care, distance services represent a significant opportunity in poor and remote regions, where one cannot expect specialized face-to-face care. The application of low-cost technologies is necessary and must be stimulated in order to implement integrated collaborative networks of remote assistance⁽⁷⁾.

Technological Innovation – Digital Health

When it comes to Information and Communication Technologies in Brazil, there is the SUS Application (“DigiSUS”) - Portal of the Ministry of Health - which brings citizens closer to public health services and has a platform with 1.2 million downloads., between smartphones with IOS and Android systems⁽⁸⁾. In addition, data from Brazilian National Telecommunications Agency -Anatel- indicate that in Brazil in 2020, there were more than 234 million mobile internet accesses. Brazilians have the highest average use of smartphones in the world: 4 hours and 48 minutes⁽⁸⁾. In this sense, with the advancement of ICTs, mobile applications aimed at the health area act as self-management tools in diseases aiming at the process of self-care, which facilitates the achievement of clinical results in the conduct of treatments, a promising proposal for self-care at home⁽⁹⁾.

According to the Brazilian Institute of Geography and Statistics - IBGE, the Brazilian population is increasingly connected. The data investigated by the Continuous National Household Sample Survey - Continuous PNAD, in the fourth quarter of 2019, refers to Information and Communication Technology, in the aspects of internet access and possession of a cell phone for personal use by people aged 10 years and over. In the period from 2018 to 2019, the percentage of those in which the cellular mobile network service worked, for the Internet or for telephony, increased from 92.4–93.2%, in urban areas, and a decrease of 68.5%. % to 68.2%, in rural areas. In these surveys, they showed that in 2019, in the population of 183.3 million people aged 10 years and over, that is, 143.5 million (78.3%) used the Internet. This percentage has been growing since 2016, as the data were 69.8% in 2017 and 74.7% in 2018. Internet use related to sex in 2018 - Men (73.6%) and in 2019 - (77, 1%) – Women in 2018 - (75.7%) and in 2019 - (79.3.%) ^{(10, 11, 12)}.

Currently, cell phones are no longer used just for phone calls or to receive and send messages, as they are increasingly developed with advanced technologies and data storage capacity for the benefit of users⁽¹³⁾.

At Paulista Medical Association - APM, a survey was carried out with 1,614 professionals to map the use of digital solutions in the routine of care in the state of Sao Paulo (Brazil), with 82.65% of physicians using technology in their day-to-day care – whether to observe patients or to optimize consultations. The purpose of this study was to map the use of technological resources in Medicine and Health where 67.66% of respondents agree with the phrase “Technology will not replace the physician, but it can replace the physician who does not use technology”. In fact, 93.68% understand that sharing information benefits everyone involved⁽¹⁴⁾.

Furthermore, research related to the “Meu Pré-Natal” Application⁽, for women during pregnancy, childbirth and the postpartum period, has certified a satisfactory gain for the relationship between health professionals and their patients ⁽¹⁵⁾. In this line of research, the "Evaluation of Mobile Applications to Promote the Health of Pregnant Women with Preeclampsia", available on iOS and Android platforms, proved the possibility of verifying whether the tools are reliable, as well as whether they had consistent information for promote the health and quality of life of pregnant women⁽¹⁶⁾.

Ethical and legal aspects

Recently, it can be highlighted that we have experienced two distinct periods for practical activities in the health area, since until March 2020 the legislation, standards and resolutions existing in Brazil did not clearly provide guidelines for health professionals, for the Health Surveillance of states, municipalities and the population about the risks and benefits of using Applications for telemedicine. This is because the topic was current and brought many controversies among professionals in the area.

With analysis of the timeline, there is the starting point with the Civil Landmark of the Internet by Law No. 12965/2014, which began to regulate the use of the Internet in Brazil with provision for principles, guarantees, rights and duties for those who use the network⁽¹⁷⁾. In the same context, also, to enable the use of digital instruments in the health area occurred the enactment of Law 13709, published on August 14, 2018, with determinations on the General Law for the protection of Personal Data - LGPD⁽¹⁸⁾, which provides on the objective of protecting the fundamental rights of the natural person. (28) And further on, with the advent of the Covid-19 pandemic, there have been relaxations in the procedures of the care provided. Both the Ministry of Health and the Federal Council of Medicine defined therapeutic guidelines that supported the insertion of ICTs in medical and other health care procedures. Moreover, the determinations of the Secretaries of Health of the States with social distancing, after the expedition of the Telemedicine Law nº 13989, of April 15, 2020, regulated attributions about general information and limitations inherent to the use of telemedicine, allowing video calls by WhatsApp or messages and other videoconference apps⁽¹⁹⁾. Still, in this sense, it is necessary to point out the expedition of Law 14129, of March 29, 2021, since it establishes principles, rules and instruments for Digital Government and for the increase of public efficiency.

In view of these considerations, the question that guided the development of this project was: “What are the advantages and benefits of developing a System capable of promoting adequate post-molar follow-up and early diagnosis of its malignancy named Gestational Trophoblastic Neoplasia, through ICTs?”

This is a cross-sectional and blind technological evaluation research for the development of a HIS, composed of two interfaces: Website for the activities of the medical team and the Application (MolaApp) for patients undergoing treatment for trophoblastic disease. gestational.

Development

For the development of the Website and Application interfaces entitled MolaApp. A team was formed with a project manager, a requirements analyst, two programmers and four systems analysts for the construction of digital tools under the coordination of the Project Office of the Department of Informatics at Unifesp.

Breadth

The HIS contains resources for registering patients with their personal, clinical and demographic data, entered through a Web interface.

After registering in the system, the patient received the apk to install the Application, available for the Android platform, which allows the beginning of online communication and the doctor-patient relationship. Furthermore, there is the possibility of issuing reports, allowing transversal and longitudinal monitoring, inserting newsletters and requests via chat.

As for the MolaApp Application, it will be used exclusively by patients in attendance to assist in communication, interaction and follow-up.

• Submission of exams: hCG dosage results, ultrasound exams, X-ray, tomography, reports and photographs performed in external laboratories (Fig. 1);

Alert messages (Fig. 2): In cases of important percentage changes, which are in some business rule, or due to the patient's need (chat).

Development and Design

The Website and the MolaApp App developed were composed of concepts, risk factors, signs, symptoms, treatments, the importance of medication and side effects, frequently asked questions, necessary health care and patient follow-up through monitoring, with the purpose of providing clarifications, stimulating therapeutic care and the importance of continuity in treatment.

The Praxis Framework and Praxis Pathway project management certification method was used, to assist and improve the effectiveness and efficiency of project delivery, increasing individual performance, team capacity and organizational maturity, since it comprises a model of processes and documentation descriptions that makes it possible to verify the way they are developed⁽²⁰⁾.

As for the development framework:

Database Server: Entity-Relationship Diagram made with ERDplus: https://erdplus.com/. Mounted on MariaDB: https://mariadb.org/;
Webservice Server development: Nodeis, Javascript: https://nodejs.org/en/;
Site Development: Quasar framework, VUEJS:https://quasar.dev/ (And Published in SPA (single page application) format;
Patient Application Development: Quasar framework, VUEJS:https://quasar.dev/ (Published with cordova for android platform);

Quality of Use and Functionality Assessment

Specialist physicians in GTD who are members of the study group of the Brazilian Association of Gestational Trophoblastic Disease, which organize themselves to coordinate the care provided in Brazil⁽²¹⁾, as well as the doctors of the DTG Ambulatory team were invited. from HUHSP/EPM/UNIFESP and the patients. Participants received an Invitation Letter with the Free and Informed Consent Term regarding the research. The medical team received a link to access the Website and the patients received the MolaApp APK, by email or WhatsApp, for download and installation on mobile devices (smartphone or tablet with Android® operating system). A brief personal training was carried out, in which the actions to be performed with the devices were specified.

For the evaluations, the following were available: Questionnaire Patients with Gestational Trophoblastic Disease and the Questionnaire of Occurrences, both developed in a REDCap environment.

The Patients with Gestational Trophoblastic Disease Questionnaire (https://redcap.epm.br/surveys/?s=RTCKCLRKP4MLXETF) was composed of two parts. The first one was composed by the demographic questions of the participants and the second by the System Usability Scale questions and one more non-mandatory essay question⁽²²⁾.

The Occurrence Questionnaire (Fig. 3) (https://redcap.epm.br/surveys/?s=RLKMXP8ANEKEPDEE) consisted of identifying the user, whether doctor or patient, and recording problems in using the app or website.

For access and functionality of the HIS interface, the website link: https://dtg.bioinfo.unifesp.br/#/ and the MolaApp APK for download: mola_paciente_rc1-04-.apk, via online (and -mail and whatsapp), to each participant, followed by an Instruction Manual for the use of the Mola System (suplementary material 1), with illustrative images that would help in the understanding of the step by step, to carry out in practice the activities of the GTD Ambulatory.

Sample characteristics

The sample was characterized in relation to the variables: age, sex, education, computer knowledge and profession (Table 1).

Age was normally distributed (Shapiro-Wilks normality test, p = 0.01648), with a mean of 41.1 years, with an one outlier, between doctors and other professions.

With regard to computer knowledge, more than half called themselves intermediaries.

Table 1

Sample characteristics
Characteristics	N = 14
Sex
Female	10 (71,4)
Male	4 (28,6)
Age
Mean (standard deviation)	41,1 (13,8)
Median	38
minimum – maximum	27–78
Education
Graduationo	4 (28,6)
Specialization	6 (42,8)
Master degree	0
Doctorate degree	4 (28,6)
Computer knowledge
Basic	5 (35,7)
Intermediary	8 (57,2)
Advanced	1 (7,1)
Profession
Doctors	9 (64,3)
Others	5 (35,7)

The tests were carried out from November 2021 to February 2022, and 28 eligible participants were invited to carry out the usability and functionality assessments for the study, distributed among physicians from ABDTG, physicians from the DTG outpatient clinic and patients undergoing treatment. 14 responses were obtained, which represents a 50% return rate.

User´s Satisfaction Evaluation

At the conclusion of the evaluation phases, using the System Usability Scale - SUS, to determine the degree of user satisfaction with the final product, the questionnaire contained ten objective questions graded on a Likert scale, with values from one to five, classified respectively such as: “strongly disagree”, “disagree”, “do not agree nor disagree”, “agree” and “strongly agree” (Fig. 4), and an optional essay question. Data were collected in a form developed in REDCap and analyzed in Microsoft Excel 2010 for Windows® and R software, version 4.1.2, as well as presented in absolute and relative frequencies⁽²²⁾.

For the total usability score measured by the 10 questions of the SUS instrument, it presented a mean of 80.7 and a median of 77.5 points.

Accurate quality of use is related to the ability and ease of users to achieve their goals with efficiency and satisfaction, communicability (quality of doctor-patient communication through the interface) and applicability (usefulness in different situations)⁽²³⁾.

About the questionnaire of occurrences during the use of the system, 13 responses were obtained, where 11 indicated the absence of problems and two doctors from the HU-HSP reported having difficulty accessing the system.

Association analysis

The association between age and SUS Score was studied using Pearson's correlation coefficient (Table 2), since the SUS Score variable showed adherence to the normal distribution by the Shapiro-Wilks test (p < 0.05). The Pearson correlation result was − 0.419, which means a low correlation.

Table 2

– Association between the age of the participants, in years, and the score obtained in the usability questionnaire (n = 14).
Correlation
Age x SUS Score	-0,419
Normality test	p
Age	0,016
SUS-Score	0,042

Although in the test feedback and final evaluation of the Health Information System, a lower response rate than the number of invited participants was obtained, since the total number of eligible recruits recruited in person, by email and by WhatsApp were 28 selected, only 14 participants (50%) came forward to evaluate the usability and functionality of the SIS. In this sense, according to studies already carried out to measure the minimum number of participants in evaluations such as this one, five users are needed among the categories per performance. In the case of different groups, such as the developed SIS (doctors and patients), five users are also recommended for each. Therefore, with this group it was possible to cover up to 80% of usability problems that could have been found^{(24, 25)}.

On the other hand, Cazañas et al.⁽²⁶⁾ suggest that there is no consensus on the ideal size. However, five users can underestimate the number of errors, and they concluded that they should use eight to nine users to eliminate problems with a small sample size. Anyway, in the present study, it had 14 users, which represents a sample above the minimum numbers indicated for usability tests and their validation.

Conceptually, usability is the ability of software to be understood, learned and operated by an individual when used for specific purposes⁽²⁷⁾.

According to the literature, a SUS score above 68 indicates an acceptable degree of usability⁽²⁷⁾. And, in an extensive analysis of the application of the SUS questionnaire, Bangor et al.⁽²⁸⁾ identified that a score of 85 would be associated with an excellent acceptance of a software or an application. In this sense, the average System Usability Scale-SUS score for evaluating the usability of the System reached the parameters described in the literature. .

In this case, the mobile devices developed for teaching, research and assistance in the treatment of Gestational Trophoblastic Disease, in one of the Reference Centers in Brazil, by the DTG Ambulatory of HUHSP/EPM/UNIFESP, evaluated for usability and functionality, achieved quality in efficiency and satisfaction that related to the capacity and the ease of handling, users could confirm that they reached their goals. Therefore, in this definition, the concepts of usability are inserted⁽²⁹⁾.

Thus, the SIS adjusted in Website and Application "MolaApp" were composed of requirements that included several factors and necessary care with the health of patients, through monitoring and in order to provide clarification, stimulate therapeutic care, the importance of continuity of treatment, the promotion of self-care and adherence to digital tools.

In this regard, the SIS incorporates a routine in the care and in the specific activities of the patients that, through monthly, biweekly or weekly self-monitoring, speeds up the insertion of data and notifications. The System with its interfaces was developed based on the best available scientific evidence, on clinical experience and on the expertise of nationally and internationally renowned specialists regarding GTD.

About the HIS interfaces, in general, they were considered clear, adequate, easy and satisfactory, as well as the Instruction Manual made available to clarify doubts in the use of the tools. The outcomes of the HIS presentations, whether in person or via web conferencing, compared to the assessments and tests that the participants performed and experienced individually, intensified the effects of the expected results. At this point, the need to expand the role of health professionals and patients in self-care education must be recognized⁽³⁰⁾.

However, it is essential to clarify that, although digital tools can help and support a medical team in terms of agility to obtain results, clarify doubts, request new exams or control appointments, this doctor-patient relationship will not exclude the face-to-face act., when necessary.

Therefore, Health and Information and Communication Technology are themes present in today's society. It comprises a cybernetic space of intersection of these areas and implies recognizing Health as a vital topic of importance to human nature to support the performance of operational and managerial actions to support the decision of Health Professionals⁽³¹⁾.

The Health Information System, after the final results, showed that it meets the essential activities of the HU/HSP/EPM/UNIFESP Specialized Outpatient Clinic in GTD, in the treatment of the disease, because it is technically adequate, practical and easy to handle the tools between its interfaces., as well as for the efficiency for the organization in the flow of the service, in the quality of the assistance provided and in the formation of a database that will allow accurate studies for continued education and professional and scientific improvement in teaching-learning in health.

Finally, one of the limitations of the present study was the lack of time and resources for the “MolaApp” Application, at this time, to also operate on the iOS system. Which will be suitable in the future, as it is programmed and enabled to join and work on the iOS platform.

GTD: Gestational trophoblastic Disease; hCG: human chorionic gonadotropin hormone; HU: University Hospital; CMH: Complete hydatidiform mole; PHM: Partial hydatidiform mole; GTN: Gestational Trophoblastic Neoplasm; UNIFESP: Federal University of Sao Paulo; HIS: Health Information System; SUS:Sytem Usability Scale; ICT: Information and Communication Technologies; ABDTG: Brazilian Association of Gestational Trophoblastic Disease.

Ethics approval and consent to participate

All methods were carried out in accordance with relevant guidelines and regulations. This study was reviewed and approved by the review board and the ethics committee of Federal University of Sao Paulo (CAAE: 29954920.1.0000.5505). At each stage, before completing the questionnaire, the participants informed consent with orally and in writing.

Consent for publication

It does not apply

Availability of data and materials

The data used and analysed during the current study are not publicly available due Federal University of Sao Paulo policy but are available from the corresponding author on reasonable request.

Competing interests

The authors declare that they have no competing interests.

Funding

The author(s) received no financial support for the research, authorship, or/ and publication of this article.

Authors' contributions

LPA, JM and PBP analyzed and interpreted the data obtained in the usability and functionality evaluations of digital devices. VTM, ACSJ, LPA, JM, PBP, SYS contributed to the development of HIS. The requirements analyzes of each stage were listed by SYS, LPA, JM and LRBC. JM, LPA, SYS, PBP, ARBN, LRBC, VTM and ACSJ contributed to the writing, critical review of the intellectual content and final approval of the manuscript.

Acknowledgements

To the medical team and the patients at the Gestational Trophoblastic Disease Reference Center at the HU/Hospital São Paulo, at the Department of Obstetrics at Escola Paulista de Medicina - Universidade Federal de São Paulo, for the opportunity to learn, study and live together a simple participation, contribution and development of this research.

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No competing interests reported.

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Development and Validation of a Health Information System for Assistance and Research in Gestational Trophoblast Disease

Status:

Version 1

Abstract

Figures

Introduction

Technological Innovation – Digital Health

Ethical and legal aspects

Methodology

Development

Breadth

Development and Design

Quality of Use and Functionality Assessment

Results

Sample characteristics

User´s Satisfaction Evaluation

Association analysis

Discussion

Conclusion

Abbreviations

Declarations

References

Additional Declarations

Supplementary Files

Status:

Version 1