MEDICATION CALCULATION IN NEONATES AND PEDIATRICS: DEVELOPMENT AND VALIDATION OF A MOBILE APPLICATIONABSTRACT
Objective: to describe the process of developing and validating a mobile application for medication dosing in neonatal and pediatric services.
Method: a methodological study based on the instructional design model with 5 stages: analysis, design, development, implementation, and evaluation. The first 3 phases of development were conducted by a computer engineer. The content and appearance validity index were measured by clinical nurses (n=20) and computer systems engineers (n=18), respectively, and the usability was evaluated with nursing students (n=61).
Results: after the development phase, the MATYMAR V 1.0 mobile app was made available on a free platform to use on the Android system. The content validity index was 1.0, while the appearance index showed variations. The usability evaluation of the app, conducted by 61 nursing students, was positive for medication dose calculations in neonatal and pediatric services.
Conclusions: the model used proved effective for developing the app, which received positive evaluations from clinical nurses and systems engineers in terms of content and appearance through the concordance index validation, as well as from nursing students in the usability evaluation. It is a useful and functional app for dose calculation, transitioning from a conventional method to a technological system, making the dosing process safer, more reliable, and time-efficient.
DESCRIPTORS:
Mobile applications; Health information technology; Drug dosage calculation; Nursing
RESUMO
Objetivo: descrever o processo de desenvolvimento e validação de um aplicativo móvel para dosagem de medicamentos em serviços neonatais e pediátricos.
Método: estudo metodológico baseado no modelo de design instrucional com 5 etapas: análise, concepção, desenvolvimento, implementação e avaliação. As primeiras 3 fases de desenvolvimento foram realizadas por um engenheiro de computação. Os índices de validade de conteúdo e de aparência foram medidos por enfermeiros clínicos (n=20) e engenheiros de sistemas de informática (n=18), respectivamente, e a avaliação de usabilidade foi medida com estudantes de enfermagem (n=61).
Resultados: após a fase de desenvolvimento, o aplicativo móvel MATYMAR V 1.0 foi disponibilizado em plataforma gratuita para utilização no Sistema Android. O índice de validade de concordância de conteúdo foi de 1,0 enquanto a aparência apresentou variações. A avaliação da usabilidade do aplicativo, realizada por 61 estudantes de enfermagem, foi positiva para o cálculo de doses de medicamentos nos serviços neonatais e pediátricos.
Conclusões: o modelo utilizado foi eficaz para o desenvolvimento do aplicativo, que foi bem avaliado por enfermeiros clínicos e engenheiros de sistemas quanto ao conteúdo e aparência por meio da validação do índice de concordância, bem como da avaliação de usabilidade pelos alunos. É um aplicativo útil e funcional para cálculo de doses, passando de uma forma convencional a um sistema tecnológico, tornando o processo de dosagem mais seguro e confiável, além de reduzir tempo.
DESCRITORES:
Aplicativos móveis; Tecnologia da informação em saúde; Cálculo de dosagem de medicamentos; Enfermagem
RESUMEN
Objetivo: Describir el proceso de desarrollo y validación de una aplicación móvil para la dosificación de medicamentos en los servicios de neonatos y pediatría.
Método: Estudio metodológico basado en el modelo de diseño instruccional con 5 etapas: análisis, diseño, desarrollo, implementación y evaluación. Las 3 primeras fases del desarrollo fueron a cargo de un ingeniero de informática. Se midió el índice de validez de contenido y apariencia por enfermeras clínicas (n=20) e ingenieros de sistemas computacionales (n=18), respectivamente, y la evaluación de la usabilidad con alumnos de enfermería (n=61).
Resultados: Después de la fase de desarrollo, se contó con la app móvil MATYMAR V 1.0 disponible en una plataforma gratuita para su uso en el Sistema Android. El índice de validez de concordancia del contenido fue de 1,0 mientras que la apariencia presentó variaciones. La evaluación de la usabilidad de la app, realizada por 61 alumnos de enfermería, fue positiva para el cálculo de dosis de medicamentos en los servicios de neonatos y pediatría.
Conclusiones: El modelo utilizado resultó eficaz para el desarrollo de la app, que fue bien evaluada por los enfermeros clínicos e ingenieros de sistemas en cuanto al contenido y apariencia a través de la validación del índice de concordancia, así como la evaluación de la usabilidad por los alumnos. Es una app útil y funcional para el cálculo de dosis pasando de una forma convencional a un sistema tecnológico haciendo el proceso de dosificación más seguro y confiable, y con disminución del tiempo.
DESCRIPTORES:
Aplicaciones móviles; Tecnología de la información en salud; Cálculo de dosificación de drogas; Enfermería
INTRODUCTION
Information and Communication Technologies (ICTs) related to health care are being widely used by health professionals, contributing to the evolution and improvement of health care practices1. These technologies have experienced rapid growth in recent years and have been used by different fields of knowledge. An important milestone in the dissemination of the use of information technologies by nursing professionals was the creation of the Technology Informatics Guiding Education Reform (TIGER), an initiative formed by a group of leaders in Nursing Informatics who seek to enable theoretical and practical knowledge of nurses in information technologies, to develop evidence-based care, using tools that support clinical decision-making2.
Thus, the use of ICTs in health care also contributes to patient safety (PS), even though PS has received special attention worldwide today, aiming to improve the quality of health care delivery to individuals, particularly to one of the most vulnerable groups-children. In hospital care, children are considered at higher risk due to their anatomical and physiological condition, which exposes them to greater potential harm compared to adults, as they are undergoing growth and, in some cases related to age, are unable to communicate symptoms3-5.
The World Health Organization (WHO) defines patient safety (PS) as the reduction of unnecessary risks to an acceptable minimum during the health care process. In this context, incorrect medication dosing constitutes a serious issue in health care, being considered one of the main adverse events experienced by pediatric patients receiving hospital care, especially those in high-complexity areas such as intensive care units and oncology departments3-4.
Medication errors, whether in prescribing, preparation and dispensing, administration, or monitoring, are significant concerns regarding PS and a quality issue. These errors lead to a wide range of problems for patients, from mild symptoms to imminent risk of death, and increased hospital stay. It is estimated that between 18.7% and 56% of adverse events are related to medication errors. To address this, the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP, 2020) described medication errors as "any preventable event that may cause or lead to inappropriate medication use or patient harm." In response, the WHO launched a global initiative aiming to reduce medication errors by 50% within 5 years, as these errors are largely preventable according to the literature5.
Due to the nature of these errors that are derived from processes with areas of opportunity in terms of control, many studies analyzing this phenomenon have focused on reducing errors in the practice of health care professionals, particularly nurses. In most countries, dosing and administering medication are interdependent interventions performed by these professionals as part of patient care. The most commonly used strategies to reduce medication errors include educational projects, medication information services, clinical pharmacist involvement, double-checking, barriers to reduce interruptions during medication calculation and preparation, implementation of smart pumps, process and prescription improvement strategies, and spontaneous reporting systems6-9 .
Little research has been conducted on the use of mobile applications (apps) to help reduce medication errors. Similarly, the WHO has embraced mobile health (mHealth) as a term that encompasses medical practices supported by mobile devices, such as cell phones and portable monitoring devices. Currently, there are over 350,000 health-related apps available worldwide, but most of these applications lack scientific evidence regarding their effectiveness and quality. Therefore, it is necessary to regulate these apps with appropriate methodologies to verify their functionality and ensure that they do not have negative repercussions on public health10. Consequently, this study aimed at describing the process of developing and validating a mobile application for medication dosing in neonatal and pediatric services.
METHODS
This project comprises methodological research based on the Systematic Design Process11 composed of 5 stages, represented by the acronym ADDIE (Analysis, Design, Development, Implementation, and Evaluation), for medication dosing in neonatal and pediatric areas for the Android operating system, developed from January 2021 to January 2023.
Instructional design is a process that serves as the foundation for creating software applications. The first 3 stages (analysis, design, and development) were part of the development phase managed by a computer systems engineer, while the last 2 stages (implementation and evaluation) were managed by the project researchers12.
During the development phase, managed by the systems engineer, the analysis stage involved defining the mathematical and medication content, including the rule of three for unit conversion and dosage calculations, as specified by the researchers, while the systems engineer outlined the technological requirements. In the design stage, the workflows, prototype proposal, and interface design were developed. During the development stage, the source code13 and directory structure were created using programming language, resulting in Version 1.0 of the app named MATYMAR.
In the validation phase, corresponding to the implementation stage, tests were conducted by the research team and computer systems engineer to detect potential errors. Following this, a pilot test was conducted with 9th-semester undergraduate students at the Unidad Académica Multidisciplinaria Mante, Universidad Autónoma de Tamaulipas, Mexico.
In the evaluation stage, content and appearance validation of the app was performed with content validity index assessments by clinical nurses and computer systems engineers, respectively, followed by usability evaluation with nursing students. Selection criteria for clinical nurses included a nursing degree and a minimum of 3 years of clinical experience in neonatology (NICU) or pediatrics (PICU). For computer systems engineers, 3 years of work experience was required. Nursing students needed to be active during the data collection period, enrolled in the 6th to 8th semesters at Unidad Académica Multidisciplinaria Mante, Tamaulipas, Mexico. Thus, 20 clinical nurses participated in content validation, 18 computer systems engineers in appearance validation, and 61 undergraduate students from the 6th to 8th semesters participated in usability evaluation. The sampling was convenience-based. The instruments for validating the app’s content, appearance, and usability were adapted from Portuguese to Spanish with permission from the original author14.They are described as follows: first, the content validation instrument, which includes 6 items and a 5-point Likert scale. 1) Strongly disagree, 2) Disagree, 3) Neutral, 4) Agree, 5) Strongly agree. The same scale was used in all 3 instruments. In the appearance validation, the instrument contains 7 items, and the usability instrument used by the students has 9 items. Additionally, for participant characterization, forms were designed with sociodemographic and occupational variables for nurses and computer engineers, and academic variables for students.
All participants were required to have a smartphone with the Android operating system and internet access. They were instructed to respond to the MARYMAT instrument, which contains items related to dose calculation, enabling them to execute and interact with the app. Additionally, they were asked to watch a YouTube video with instructions for downloading the app. After completing these steps, participants were to fill out a characterization form and the content, appearance, and usability validation instruments, all of which were preceded by signing an informed consent form.
The content and appearance validation index were calculated using Excel, resulting in an adequate content validity evidence of 0.9015. Usability evaluation was performed using SPSS software, where descriptive statistics such as frequencies, percentages, and mean were used for the age variable.
The project was approved by the Ethics and Research Committee, and written informed consent was obtained from all participants.
RESULTS
Analysis stage
During this stage, records were reviewed, and information was extracted from documents containing data on the mathematical investigation of medication dosing. Virtual meetings were held on the Microsoft Teams platform with the research team and the programmer (computer systems engineer). An Excel file was created containing a table with columns for data on medications, including name, presentation, clinical indications, side effects, and other related information such as dilution and suggested administration time. In this Version 1.0, there are a total of 25 commonly used medications in neonatal and pediatric areas.
Design stage
Workflows were defined. A prototype proposal was presented, with meetings held via Microsoft Teams to evaluate the final design of the MATYMAR mobile application.
Below are essential screenshots corresponding to the mobile application. This draft is the result of the design and analysis conducted during the mobile application development process. In Figure 1, one of the app's screens is shown, featuring 2 buttons. The first button corresponds to the medication dosage calculator using the simple rule of three, along with the selected medications for this version. The second button provides access to the medication manual, which includes information on the drug category, incompatibility, adverse effects, recommended dilution, recommended dilution volume, and recommended infusion time (Figure 1).
This screenshot illustrates an example of a medication dosage calculation. It begins with the generic name of the medication (amikacin), followed by its presentation. For medications with multiple presentations, a small tab allows users to click and select the most appropriate option. Next, the requested amount is specified, where users can also select between grams (g), milligrams (mg), or micrograms (mcg) according to the medical prescription via a dropdown menu. The screen then offers options to calculate or clear the input. Finally, after selecting "calculate," the result is displayed in milliliters, indicating the precise amount of medication to administer (Figure 2).
Development stage
Description of mobile application interfaces
In this phase, the source code is described; this is text written in a programming language that implements the functionalities outlined in the design. For Android mobile applications, JAVA is used with the Android Studio IDE. Coding standards and application structure are also established.
Implementation stage
Initial testing was conducted with the researchers and systems engineers, making the necessary modifications. Subsequently, a real-time pilot test was carried out with 9th-semester students from the same academic unit until no further errors were identified.
Evaluation stage
In the content evaluation of the app, a total of 20 clinical nurses participated. The average age was 37.9 years old, with a minimum of 25 and a maximum of 61 (SD 10.4). 95.0% of the participants (19) were women. Regarding academic and professional variables, the average time since graduation was 13.9 years. The average work experience in neonatal and pediatric areas was 9.2 years and 9.8 years, respectively, and the average teaching experience was 5.8 years. All participants (100.0%, 20) had specialization in the area, with 10.0% (2) holding a master's degree and 5.0% (1) having a scientific publication.
The content validity index was 1.0 for all items in the instrument (Table 1).
Evaluation of Appearance by Computer Systems Engineers. Regarding the sociodemographic and professional characteristics of the 18 participants in the computer systems field, it was found that 61.0% (11) were men, with an average age of 37 years old (SD 8.3). Among them, 38.9% (7) had a specialty and 33.0% (6) had a master's degree. Of the participants, 83.3% (15) reported having experience in software development, 5.6% (1) had published scientific articles, and 11.1% (2) participated in research groups.
Regarding the content validity index for the app's appearance as assessed by computer systems engineers, there were variations: Items 1 and 4 had an index of 0.8, followed by Items 2, 5, and 6 with an index of 0.9, and finally Items 3 and 7 with an index of 1.0 (Table 2).
Usability Evaluation of the App by Nursing Students. Below are the sociodemographic and academic characteristics, along with the usability evaluation of the app by the participating students (61 in total). The average age was 21 years old, with a minimum of 20 and a maximum of 33 (SD 2.0). 80.3% (49) were women, 70.5% were in their sixth semester, and 29.5% (18) were in their eighth semester. Regarding periods, 57.4% (35) were in the morning schedule. Only 12.9% of the students had completed a course on medication dosing. Regarding the item “How do you rate your proficiency in dose calculation?” 49.2% (30) rated it as good, and 41.0% (25) rated it as fair. The total number of participants (61) considers it necessary to have a course on medication dosing.
Regarding the study variable "Usability Evaluation of the App" by nursing students, for the item "The app is easy to download on the Android system," 68.9% (42) strongly agreed, 14.7% (9) agreed, 3.3% (2) disagreed, and 1.6% (1) strongly disagreed. For the item "Overall, the app is easy to use," 78.7% (48) strongly agreed, 13.1% (8) agreed, 6.6% (4) remained neutral, and 1.6% (1) disagreed. For the item "The app provides effective help," 85.2% (52) strongly agreed, 6.6% (4) agreed, and 6.6% (4) remained neutral.
For the item "The language used in the app is easy to understand," 82% (50) strongly agreed, 11.5% (7) agreed, and 1.6% (1) disagreed, with the same percentage strongly disagreeing. Continuing with the usability evaluation, for the aspect “the interface of the app is attractive,” 68.9% (42) strongly agreed, 21.3% (13) agreed, and 4.9% (3) remained neutral. For the item “overall, the app optimizes the medication dose calculation,” 88.5% (54) strongly agreed, 6.6% (4) agreed, and 3.3% (2) disagreed.
For the item “the app assists in the medication dose calculation,” 86.9% (53) strongly agreed and 11.5% (7) agreed. For the item "The app enhances knowledge about dose calculation," 82.0% (50) strongly agreed, and 16.4% (10) agreed. Finally, for the item "The app improves understanding of dose calculation," 77.0% (47) strongly agreed, 19.8% (12) agreed, and 1.6% (1) each neutral and partially disagreed (Table 3).
DISCUSSION
This research contributes to the development of a mobile app (MATYMAR, Version 1.0) for medication dose calculation in neonatology and pediatrics using the ADDIE Model. This instructional design model is employed in both pedagogy and software development 16. In this way, the software was designed for the Android system and is available for download on a free platform (APK Pure). The choice of the Android system was due to its greater compatibility with users' smartphones. The user needs an internet connection for downloading and using the app.
The first three stages of the ADDIE model-analysis, design, and development-allowed for the construction of App Version 1.0. The subsequent stages-implementation and evaluation-enabled its validation and practical application in a real-world scenario. Initially, the app was implemented to identify potential errors in unit conversions, which are significant challenges for students and nurses in clinical practice, as well as to ensure that the app provides users with accurate, error-free calculations. Changes were made in this version accordingly. The use of innovative apps for smartphones is particularly recommended in pediatric units17.
The MATYMAR Version 1.0 software is an app designed to facilitate medication dose calculation in neonatology and pediatrics. It uses a simple rule of three and reduces errors related to unit conversions, such as grams to milligrams and milligrams to micrograms, which are challenging for both clinical nurses and nursing students18. This app aims to prevent medication errors that can arise from complex calculations.
This app contains, in this version, 25 of the most used medications in pediatric and neonatal patients, including antibiotics, proton pump inhibitors, opioids, diuretics, and antiepileptics. These are also among the most associated with medication errors in critical care services. 19 Thus, the development of new products or adaptations of existing ones is encouraged to contribute to appropriate care that meets the nurses’ needs20.
Additionally, the app features a medication manual to assist users, including students and nurses, in medication administration. This manual provides information on medication categories, clinical uses, incompatibilities, adverse effects, and recommendations for dilution solutions, volume of dilution, and infusion time.
In this study, content, appearance, and usability were analyzed. This contrasts with a study on the validation of mobile applications for promoting the health of pregnant women, where various applications were analyzed based on the following variables: design, usability, language, instructions, security, and transferability. It is noteworthy that, in that study, the content was not analyzed by subject matter experts, which was a crucial step in evaluating the MATYMAR app21.
It is evident that applications are being developed to use in nursing, both in education and clinical practice. For instance, apps have been created for teaching surgical techniques, prenatal care, the International Classification for Nursing Practice (ICNP), and nursing processes in neonatal units, among many others14,16,20-21.
In this way, this proposal is similar to other apps14,23 that have developed phases of construction and validation, such as those for teaching surgical techniques and for creating clinic record and nursing diagnoses. Unlike other authors, one study 22 presents only the construction phase, while another21 mentions having the evaluation phase for pregnant users concerning functionality and usability for a different study. The development time of the app can be lengthy, so authors might choose to focus only on the construction phases and conduct content evaluation or validation at another time14,16,21-22.
An app called CuidarTech has many similarities with this study regarding the content variable, as the author analyzes the content through a panel of 9 subject matter experts, obtaining a CVI above 0.79 in the evaluated sections, results very similar to those of the MATYMAR app16.
Another study reports the development and validation of a mobile application for guiding the care of venous thromboembolism. For the validation phase, a panel of 11 specialists from different health fields, a systems engineer, and a graphic designer were selected based on clear criteria, along with 30 users. The content was validated with appropriate ratings to validate the application. The same study also evaluates usability, which are crucial elements for the evaluation phase of mobile technologies, and were similarly conducted for the MATYMAR app24.
The validation of appearance and content of an app for the prevention and control of syphilis was also studied using a panel of 22 subject matter experts. In such case, the experts obtained a Content Validity Index of 0.80. This result is similar to the data found in the present study, which also showed satisfactory outcomes, allowing the application to be considered validated in terms of both content and appearance in both studies25.
It is notable that different models were used for the development of apps, such as the instructional design model, which differs from the model used for the MATYMAR app. What is striking about the model used26 for structuring the application for basic life support training in cases of cardiac arrest is that, during the evaluation phase, a pre-test is conducted, followed by access to the application’s content and a post-test. This approach allows for ongoing evaluation of the MATYMAR application. Similar data reported in the study includes content validation through a panel of experts. Another significant aspect25 is that the appearance was not evaluated with the target population. In contrast, the MATYMAR app was evaluated with content assessed by subject matter experts, appearance assessed by engineers experienced in mobile app development, and usability assessed by the target population (nursing students).
In this context, the content evaluation by 20 expert nurses in neonatology and pediatrics generally indicates that the selection of topics for dosage calculations using the rule of three and the app's objective were met. All items received high ratings, with the majority selecting "agree" and "strongly agree" on the Likert scale used. In clinical practice, which is the real-world setting, dose calculation is a process that nurses perform multiple times for each patient during a single shift at the time of medication administration. Since nurses are responsible for this task, their participation in this evaluation was crucial.
Regarding the evaluation of the app's appearance by 18 computer systems engineers, most items were rated positively. However, two aspects require attention: "the app is easy to download" and "the interface is attractive." These points are significant, as the engineers' expertise allows them to identify issues that might not be noticeable to clinical nurses, the end-users. This feedback is crucial for improving the app and ensuring a high-quality product.
Finally, in the usability evaluation conducted with 61 nursing students, the app was mostly well-rated across all items with "Agree" and "Strongly Agree" options, although a small percentage of students selected "Strongly Disagree" and "Disagree" for all items. Certainly, evaluating the app is crucial, and if the ADDIE Model is used, this phase is the final step. It must be conducted with validated and reliable instruments. Some apps have been assessed based on functional adequacy, reliability, usability, performance efficiency, compatibility, and security, as seen in the app for the nursing process in a neonatal intensive care unit16.
CONCLUSIONS
The ADDIE model proved to be an effective tool for developing the app, enabling reliable and safe calculations and reducing the time required for mathematical processes. The app can be utilized as an educational tool for students and nurses in continuing education courses on medication dosage calculations. It is also suitable for clinical practice among nurses and for undergraduate students in neonatal, pediatric, and pediatric emergency services, where dosage calculations are frequently performed.
The app advances from conventional dosage calculation methods, which can lead to adverse events, to a technological system that minimizes calculation errors and enhances safety in the process. The evaluation of content, appearance, and usability using validated and reliable instruments with various users-including clinical nurses, systems engineers, and students-demonstrates the app's usefulness and functionality for its intended purpose. A limitation of this study is that the app was designed exclusively for the Android operating system and currently includes only intravenous medications. Future versions will expand to include additional medications and will be developed for the iOS system.
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NOTES
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ORIGIN OF THE ARTICLE
Article extracted from the Dissertation - Desarrollo de una app móvil para la dosificación de medicamentos en los servicios de neonatos y pediatría, presented to the Master of Nursing Postgraduate Program, of the Facultad de Enfermería Tampico, Universidad Autónoma de Tamaulipas, in 2023.
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APPROVAL OF ETHICS COMMITTEE IN RESEARCH
Approved by the Ethics and Research Committee of the Facultad de Enfermería of Tampico. Universidad Autónoma de Tamaulipas, Opinion No. FET/CEI-2022/001
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TRANSLATED BY
Leonardo Parachú.
