Author: admin

Legal settlement ensures Lachlan Murdoch will take control of sprawling media portfolio after 94-year-old mogul’s death.

Rupert Murdoch’s family has reached a deal to end the years-long succession battle over the mogul’s media empire.

The deal, announced by News Corp on Monday, will see eldest son Lachlan Murdoch take control of a sprawling media portfolio that includes Fox News, The Wall Street Journal, The New York Post, and The Times.

The agreement helps ensure that Murdoch’s media properties will retain their conservative bent long after the 94-year-old patriarch’s death.

Under the settlement, Lachlan, who is widely viewed as more aligned with his father’s conservative views than his siblings, and his two younger sisters, Grace and Chloe, will be beneficiaries of a new family trust that has a controlling stake in Fox Corporation and News Corp.

The deal stipulates that the trust will be in place until 2050.

Voting rights will rest “solely” with Lachlan, 54, who has served as chairman of News Corp and CEO of Fox since his father stepped down from the day-to-day running of the businesses in 2023.

Lachlan’s three oldest siblings, James, Elizabeth and Prudence, will relinquish their stakes in an existing family trust, receiving an equal split of the equity sales.

Under the deal, the three elder siblings will be subject to a “long-term standstill agreement” barring them from acquiring shares of News Corp and Fox Corporation and “taking certain other actions with respect to the companies”.

US media estimated the payout for the three siblings at about $3.3bn.

“News Corp’s board of directors welcomes these developments and believes that the leadership, vision and management by the Company’s Chair, Lachlan Murdoch, will continue to be important to guiding the Company’s strategy and success,” News Corp said in a statement.

The settlement caps a saga that has captivated political and media circles, and drawn comparisons with the plot of HBO’s award-winning drama Succession.

“Rupert Murdoch has built his reputation on being aggressive in securing what he wants, and he wanted Lachlan Murdoch to control both Fox Corp and News Corp,” Lynne Vincent, an associate professor of management at Syracuse University’s Whitman School of Management, told Al Jazeera.

“Not surprisingly, that is what is going to happen. Rupert Murdoch is very effective at getting what he wants.”

Vincent said Lachlan Murdoch’s control of the media portfolio would ensure “business as usual” at the outlets.

“From what we know, Lachlan Murdoch’s views and values are very similar to Rupert Murdoch’s,” she said.

“From an organisational perspective, this provides Fox Corp and News Corp with a sense of stability, which might be appealing to some stakeholders.”

Andrew Dodd, director of the Centre for Advancing Journalism at the University of Melbourne, called the settlement “bad news” for media diversity and pluralism.

“This ensures the respective news outlets remain right wing and reactionary and will probably continue to be driven by the same sorts of agendas that have consumed Rupert over the last five decades,” Dodd told Al Jazeera.

The legal fight over Rupert Murdoch’s succession plans erupted in 2023, when the Australian-born mogul sought to change the structure of the family trust to give full control of his companies to Lachlan after his death.

James, Elizabeth and Prudence, who stood to inherit equal control of the companies along with Lachlan, took their father to court to block the bid.

In December, a probate court in the US state of Nevada ruled against the attempt to change the trust, describing it as a “carefully crafted charade” designed to “permanently cement” Lachlan Murdoch’s control.

Mitsui & Co., Ltd. (“Mitsui”, Head Office: Tokyo, President and CEO: Kenichi Hori) has agreed and signed related agreements today with the multinational mining and metals corporation BHP to acquire an indirect 7% interest in the Ministers North iron ore deposit (“Ministers North”), currently owned 100% by BHP.

Itochu Corporation (“Itochu”, Head Office: Tokyo, President and COO: Keita Ishii) has also agreed and signed the related agreements to acquire an indirect 8% interest in the Ministers North. Following the fulfillment of the conditions precedent, the shareholding interest of Ministers North between Mitsui, BHP and Itochu will become 7%, 85% and 8% respectively, aligned with the interest of the existing Western Australia iron ore business owned by the three companies.

Ministers North is located in the Pilbara region of Western Australia, where Mitsui has been engaged in iron ore projects since the 1960s. It is close to iron ore mines and infrastructure owned jointly by Mitsui, BHP and Itochu. In addition to low operating costs as an open-cut mine, Ministers North is expected to offer synergistic benefits through integrated operations with existing mines and utilization of existing infrastructure owned by Mitsui, BHP and Itochu. It is anticipated that this will lower development costs for Ministers North and allow highly cost competitive operations. Development of Ministers North is subject to a potential final investment decision by June 2026. Once developed, Ministers North would bolster Mitsui’s equity-based production volume^* and long-term earnings base. (*62 million tons in FY March 2025)

Mitsui has defined “Industrial Business Solutions” as one of its Key Strategic Initiatives in its Medium-term Management Plan 2026, and has been making efforts to provide solutions for the stable supply of essential resource, materials, infrastructure etc. Steel is a vital material for all industries, and its demand is expected to remain strong especially in Asia. Mitsui will contribute to long-term economic growth in Asia through acquisition, development, and production of Ministers North.

Yandi iron ore mine, approximately 13km from the Ministers North deposit.

Locations of iron ore projects with BHP

Introduction

A medicine package leaflet contains information about a drug’s safe and effective use, such as its active ingredients, indications, dosage, administration, precautions, and storage conditions. A patient-centered package leaflet can enhance the readability and usability of the information provided. Readability refers to how easily and clearly the text can be read and understood based on linguistic complexity, while usability focuses on the user’s experience in finding, comprehending, and applying the information.¹ It plays a crucial role in promoting appropriate medication use by facilitating informed decision-making and helping healthcare professionals counsel patients, which can enhance medication adherence.² Given its importance, the leaflet is a key document reviewed during the drug approval process to ensure it meets legal requirements and is well prepared. In many countries, including South Korea, medicine package leaflets are printed and distributed on paper, enclosed in the product container or packaging, and provided to patients or healthcare professionals, such as doctors and pharmacists.

Recent technological advancements have led to several efforts to provide information about medicines online. The COVID-19 pandemic significantly accelerated the digital transformation in the healthcare sector,³ making e-labeling increasingly popular. Although there is no universally accepted definition of e-labeling, it typically refers to delivering medicine package leaflets electronically.⁴ E-labeling is also known as electronic Product Information (ePI), e-label or e-leaflet, depending on the country or region. Despite the variations in terminology, recent initiatives from regulatory authorities and the pharmaceutical industry have converged on a common understanding of e-labeling as a tool to complement or replace traditional paper leaflets. Research on e-labeling has highlighted several benefits,^4–6 including providing patients and healthcare professionals with instant access to up-to-date drug information, personalizing content for user-friendliness, enhancing information sharing through improved compatibility, and offering environmental benefits by reducing the need for paper leaflets.

Adoption of e-labeling at the national level is occurring worldwide. In Japan, the Act on “Securing Quality, Efficacy, and Safety of Products Including Pharmaceuticals and Medical Devices” was amended in December 2019 and enforced in August 2021, allowing prescription drug leaflets to be provided exclusively in electronic format.⁷ Singapore has been running an e-label pilot since 2019, allowing pharmaceutical companies to adopt e-labeling voluntarily.⁸ Initially, it was only applied to prescription drugs, but as of April 2024, e-labeling has been extended to non-prescription drugs. The European Union (EU) established key principles for the development of ePIs for medicinal products for human use in January 2020.⁹ Some EU member states, including Denmark, Netherlands, Spain, and Sweden, have run a pilot project from July 2023 to August 2024 to examine the utility of ePIs.¹⁰ In South Korea, legal amendments took effect in January 2024, allowing certain prescription drugs to be distributed without paper leaflets, relying solely on electronic versions.¹¹

However, the benefits of e-labeling may not be uniformly applicable to different countries and populations because of discrepancies in the management of drug leaflets and e-labeling. Various studies on patient perceptions of e-labeling^12–14 have shown that some patients appreciate e-labeling, while others—particularly older adults—express concerns about accessibility, privacy, and difficulty in finding specific information.^12,13 Surveys indicate that many patients would accept e-labeling if pharmacies continued providing paper copies upon request.¹⁴ If e-labeling proves to be less effective than paper-based package leaflets in terms of readability and usability, it may increase the risk of inappropriate medicine use and reduce medication adherence. These limitations are particularly concerning for individuals with limited digital and/or medication literacy, such as older adults, and may ultimately undermine public health outcomes while impeding efforts to promote patient empowerment. While some studies only address patient perceptions and expectations of e-labeling, very few empirical studies have demonstrated whether e-labeling can actually increase the readability and usability of drug leaflets and meet patient expectations. Notably, no such studies have been conducted in the Korean context.

This study investigates whether e-labeling improves readability and usability compared to traditional paper leaflets in the South Korean context. Using a user testing method, we explored factors that enhance or hinder the effectiveness of e-labeling. User testing is a mixed-methods approach that incorporates both quantitative and qualitative findings to evaluate the readability and usability of package leaflets based on participants’ ability to use them.¹⁵ The guideline published by the European Commission recommends user testing for consulting with patient populations to ensure readability and usability of package leaflets under Article 59(3) of Directive 2001/83/EC.¹⁶ Unlike traditional content-based readability assessments—such as the Flesch–Kincaid formula, SMOG formula, or FOG readability test—user testing provides insight into actual health literacy skills, rather than relying solely on word or sentence length.¹⁷ User testing is not currently mandatory for developing drug leaflets in South Korea, and no study has evaluated the utilization of e-labeling and compared it to the readability of paper leaflets. The results of this study can provide empirical evidence for countries considering introducing e-labeling and developing relevant policies.

Materials and Methods

Study Design

We used user testing, a mixed-methods approach to evaluate the readability and usability of package leaflets in both paper and electronic formats. Quantitative data were collected through a user testing questionnaire to evaluate participants’ ability to locate and understand information in the package leaflets, specifically assessing traceability, tracking speed, and comprehension. Additionally, qualitative data were gathered through semi-structured interviews to explore participants’ perceptions of the leaflet they used, the challenges they faced in finding and understanding information, and their views on the potential adoption of e-labeling.

User testing procedures followed the recommendations outlined in the European Commission guideline,¹⁶ which includes standards for participant selection, testing protocols, and evaluation criteria. According to the guideline,¹⁶ if deficiencies are identified during testing, the leaflet should be revised and retested with new participants until the criteria are met. However, this study did not aim to optimize or validate a specific leaflet version for regulatory approval. Instead, it focused on evaluating the current readability and usability of package leaflets in both printed and electronic formats. Therefore, the testing procedure was conducted once for each format without repetition.

Tested Materials

We conducted a comparative assessment of the paper and electronic versions of package leaflets (e-labeling) for two therapeutic drug classes: antihypertensive (prescription drug) and non-steroidal anti-inflammatory drug (NSAID) (non-prescription drug). Based on publicly available national supply data from the Korean Statistical Information Service (KOSIS), these classes were identified as top-supply scale products. Antihypertensives require high medication adherence for chronic disease management,¹⁸ making clear and accessible information particularly critical. NSAIDs were selected as the most frequently supplied non-prescription drugs and the class associated with the highest number of adverse event reports in South Korea as of 2020.¹⁹ Final products within each class were selected based on the following criteria: (1) dispensing and administration practices, particularly whether package inserts are provided to patients in South Korean healthcare settings; (2) formulation type, with a focus on tablets due to their widespread use; and (3) the complexity of package leaflets, including document length, structure, and the amount of safety-related information.

Paper leaflets were evaluated using the actual inserts provided in each product’s packaging. The electronic versions of package leaflets were retrieved as PDF versions from the official website of the Ministry of Food and Drug Safety (MFDS), the national regulatory authority in South Korea. These PDF files maintained the original layout and structure of the paper format and were not adapted for web-based presentation.

Participants

Participants were recruited through convenience sampling via public notices posted in Goyang-si, where the interviews were conducted. Following the European Commission guideline,¹⁶ which recommends 10 to 20 participants per user testing condition, a total of 77 individuals were enrolled and allocated across four study groups (antihypertensive vs NSAID × paper leaflet vs e-labeling). Group assignment considered participants’ sex, age, and education level to promote demographic balance. Healthcare professionals (e.g., physicians, nurses, pharmacists) and individuals unable to read the materials, even with visual aids, were excluded. Additionally, participants who had used either drug within the past six months were excluded to minimize potential bias from prior familiarity.

Questionnaires

The questions were developed specifically for this study based on the principles outlined in the guideline,¹⁶ which recommends that user testing questions address important and complex issues, assess participants’ ability to find and understand the information, and evaluate their capacity to act appropriately based on it. The questions covered all necessary aspects of medicine use, including safety-related issues such as side effects, interactions, dosage, and indications. The questions were distributed in accordance with the amount of information provided in the leaflets. The guideline suggested using 12–15 questions; therefore, we developed 15 questions for each drug. The proportion of questions for both medicines was designed to be similar to minimize differences in difficulty. When developing the questions, we tried to avoid emphasizing either the positive or negative aspects of the medicines. The questions were organized randomly so that the flow did not follow the order presented in the leaflets. A pilot test was conducted with three participants for each study condition to ensure that patients understood the questions well. Minor revisions were made to improve clarity and flow based on their feedback. The questions for each drug are listed in Boxes 1 and 2.

Box 2 User Testing Questions for the NSAID Leaflet

Data Collection

User-testing interviews were conducted for one month, from September 14, 2020, to October 14, 2020. These interviews took place individually in a quiet, private room on the Dongguk University campus, with the author (JW) conducting each face-to-face interview one-on-one with the participants. Participants were asked to read the package leaflets thoroughly before answering the interviewer’s questions. They could take as much time as they needed to view the content of the paper leaflets and e-labeling. Each user testing interview was designed to last no more than 45 min to avoid tiring the participants.¹⁶ Participants were allowed to use a pen to underline or mark information while reading the paper leaflets. When using the e-labeling, participants scanned the QR code created for this study which was placed on the outer packaging of the drug, using their own mobile phones. This approach enabled them to interact with the e-labeling content in a natural and familiar manner, utilizing features such as zoom or search functions with comfort. After reading the leaflets, the interviewer asked the participants to answer questions, which they could answer while looking at the leaflets.

Quantitative data were collected by three criteria. The first criterion was traceability.¹⁶ The participants were asked to indicate where they could find the information in the leaflet. Participants were rated as “unsuccessful” if they failed to find the correct information, gave up trying to find it, or took more than 3 min per question. The second criterion was tracking speed, which is not specified in the European Commission guideline¹⁶ but was adopted from a previous study²⁰ conducted in South Korea. This measure allowed for a detailed comparison between paper leaflets and e-labeling. It refers to how quickly participants found the desired information in the leaflets. The interviewer evaluated it on a 5-point scale (5: found the information immediately or within 30 seconds, 4: found the information within 1 min, 3: found the information within 1–2 min, 2: found the information after more than 2 min, 1: failed to find the information, including cases of incorrect answers or delays exceeding 3 min).²⁰ The third criterion was comprehension.¹⁶ Since we did not measure the participants’ pre-existing medical and pharmaceutical knowledge or memory skills, they were asked to rephrase the content of the documents in their own words. All three criteria were applied consistently to evaluate both leaflet formats (paper and e-labeling).

Once participants had answered all the questions, qualitative data were collected through short, semi-structured interviews. Participants rated their satisfaction with the paper leaflets and e-labeling. They were also encouraged to elaborate on factors that assisted or hindered their ability to find and understand the information. We also asked about their perceptions of implementing e-labeling and how they would feel if paper leaflets were no longer available and could only be viewed electronically, such as on a mobile phone or computer.

Analysis

All interviews were audio-recorded and transcribed verbatim. The first author (JW) checked the accuracy of the transcripts by reviewing the audio recordings. The qualitative data were managed and analyzed using MAXQDA 24 (VERBI Software GmbH, Berlin, Germany). A content analysis approach was used to identify and categorize themes and patterns.²¹ Both authors (JW and KH) read each transcript independently, identified codes and grouped them into themes. Any discrepancies were resolved through group discussions until a consensus was reached. Quantitative data were analyzed using IBM SPSS Statistics 29.0 (IBM Corp., Armonk, NY, USA). To assess potential baseline imbalances between participants assigned to the paper leaflet and e-labeling groups within each therapeutic drug class, chi-squared tests (or Fisher’s exact tests, where appropriate) were used for categorical variables and independent t-tests for continuous variables. User testing outcomes (traceability, tracking speed, and comprehension) were presented descriptively.

Ethics

The study was approved by the Dongguk University Institutional Review Board on May 15, 2020 (Approval Number: DUIRB-202005-00) and conducted in accordance with the Declaration of Helsinki for research on human subjects. All participants provided written informed consent prior to participation, including consent for audio recording and the use of anonymized, direct quotes in publication. Before the interviews, participants were fully informed of the study’s purpose, procedures, and interview duration. They were also informed that participation was voluntary, and that they could withdraw at any time. To ensure participants’ anonymity and data confidentiality, all data were de-identified and stored securely in accordance with relevant guidelines and regulations.

Results

Participants’ Characteristics

The demographic characteristics of the participants are presented in Table 1. To assess baseline imbalance, we compared sex, age, education level, average monthly household income, occupational status (clerical vs non-clerical), and marital status across study groups. The analysis revealed no statistically significant differences, indicating that participants were broadly similar in their ability to find and understand information in the package leaflet.

Table 1 Participants’ Characteristics

Quantitative Findings

Table 2 summarizes the results of the readability assessment for paper leaflets and e-labeling. For the antihypertensive, information traceability in the paper leaflet was 68.8%, reduced by 4.7% when provided electronically. The average tracking speed was also 0.08 points lower for electronic delivery than for paper, and comprehension decreased by 3.3%.

Table 2 Summary of User Test Results

The NSAID showed a more pronounced drop in all metrics than the antihypertensive when the information was provided electronically rather than on paper. Its traceability dropped by 7.0%, tracking speed decreased by 0.19 points, and comprehension declined by 5.7%. Although the decline was more substantial for the NSAID, the antihypertensive had lower values for all metrics, making it more challenging to track and understand the desired information.

Tables 3 and 4 show the differences in traceability, tracking speed, and comprehension by question. According to the guidelines,¹⁶ a leaflet is considered readable if 90% of participants can locate the correct information and 90% of them understand it. However, none of the drugs and delivery methods evaluated in this study met these criteria. For the antihypertensive, no question in the paper leaflet was successfully tracked by all participants. Four questions (2, 3, 14, and 15) had 100% traceability for the e-labeling group. However, question 6 had 0% traceability, as no one could track the information. The paper leaflet’s lowest tracking rates were for questions 4 and 6. When comparing the number of questions answered correctly by more than half of the participants, 11 out of 15 (73.3%) were answered correctly using the paper leaflet, compared to 9 out of 15 (60.0%) with e-labeling, showing a slight decrease in accuracy with electronic delivery. For some questions, participants struggled to understand the content even after finding the correct information, which indicated decreased comprehension.

Table 3 Traceability, Tracking Speed, and Comprehension for the Antihypertensive by Question

Table 4 Traceability, Tracking Speed, and Comprehension for the NSAID by Question

For the NSAID, no question except for question 9 achieved 100% traceability in either format. For questions with a tracking rate of 50% or higher, 13 out of 15 (86.7%) were identified in the paper leaflet, with 12 out of 15 (80.0%) in the e-labeling, which is a relatively high rate compared with the antihypertensive. The lowest-tracked questions by the delivery method were question 10 in the paper leaflet and questions 6 and 10 in the e-labeling. These included questions regarding interactions with other medicines (question 6) and availability by prescription (question 10). Some questions were misunderstood, even when the correct information was tracked, as was also observed with the antihypertensive. Figures 1 and 2 visualize these outcomes by question.

Figure 1 Comparison of traceability, tracking speed, and comprehension for the antihypertensive by question. Abbreviations: EL, Electronic Leaflet; PL, Paper Leaflet.

Figure 2 Comparison of traceability, tracking speed, and comprehension for the NSAID by question. Abbreviations: EL, Electronic Leaflet; PL, Paper Leaflet.

Qualitative Findings

Barriers to Readability and Usability in Paper Leaflets

Participants complained about the paper leaflets, with negative evaluations being predominant in terms of readability and usability. Three main issues were identified: small font size, complicated terminology, and document structure obscuring important information. The font size was the most straightforward complaint among users using paper leaflets. Many suggested that increasing the text size would encourage more people to read more leaflets, even if it required a larger paper size or more sheets.

I have always felt manufacturers should make the font size of the leaflets bigger. I ignore the leaflets because it (font size) is too small. I just put them (leaflets) away whenever I read. (P19, 40s, NSAID paper leaflet group)

Complicated terminology substantially contributed to poor readability. Terms only understood by experts made it challenging for users to grasp the content of the leaflets. It requires additional effort from the user, who must repeatedly read the leaflet to understand it, reducing its overall utilization.

Professionals might know all the terms, but most people still don’t. I don’t understand what the leaflets are saying; it’s the same information, but I can’t make sense of it. (P18, 40s, NSAID paper leaflet group)

Most participants agreed that leaflet formatting was a major problem, noting that it complicated the process of distinguishing important information and understanding the document’s flow and structure. Several alternatives were suggested to improve the problem, such as highlighting essential information using bold text and prominent colors or placing it at the front of the leaflets.

Everything is written in the same font size, which is too small. The manufacturer should use different colors or make the important information larger. Alternatively, just put the important stuff in the front. (P17, 50s, antihypertensive paper leaflet group)

Mixed Perceptions of E-Labeling: Advantages and Usability Issues

Participants’ perceptions of e-labeling, particularly in terms of readability and usability, were mixed, encompassing both positive and negative aspects. Since the paper leaflets were merely converted into PDF format for use as e-labeling, issues such as the use of complicated terminology and poorly structured content that obscured key information remained evident in the e-labeling format. However, participants positively evaluated e-labeling for two reasons: it freed them from the constraints of text size and allowed them to find the information through the search function. Viewing e-labeling on a mobile phone allowed a larger display, which many participants utilized during interviews. Even though some participants did not use the search function during the interviews, they were aware of it and expressed plans to use it in the future when accessing e-labeling.

It is more convenient to see the text because I cannot adjust the size of the text on paper, but I can adjust the size of the text on the smartphone. (P19, 40s, NSAID e-labeling group)

If I use e-labeling on the Internet, I can search and type in the word for the information I want and get to that part quickly, rather than reading it in lines. It is more convenient. (P10, 20s, antihypertensive e-labeling group)

However, there were limitations in navigating information on mobile phones when using e-labeling. Typically, users refer to the table of contents or skim headings and subheadings to grasp the content and find the specific information they need. However, viewing e-labeling on a mobile phone does not allow one to grasp the contents of the entire document at a glance but only allows zooming in on a specific location, which may further limit the utilization of drug leaflets. Many participants expressed frustration with navigating back and forth within the document to find the information they needed. They also found it challenging to determine which of the search results or browsed content contained the exact information they were looking for. Overall, paper leaflets were considered more convenient for understanding the structure and finding specific details.

I can increase the font size on my phone, but it takes me a long time to zoom in to find what I am looking for because I do not know where the information is. With paper leaflets, I can see the document’s structure at a glance and find the information faster. (P5, 20s, antihypertensive e-labeling group)

I wish only the exact information I was looking for would show up, but there’s so much similar content scattered throughout the leaflet. To make sure what I’m looking for, I have to go through everything, so I end up reading it all from the beginning again. (P16, 40s, antihypertensive e-labeling group)

Participants also shared their views on the accessibility of e-labeling, which was often compared to that of paper leaflets. These responses revealed a mix of both positive and negative aspects. For example, strong resistance to and negative perceptions of e-labeling were primarily driven by concerns over reduced accessibility and usability of drug information among older adults. Older people are less likely to use electronic devices such as mobile phones, which raised concerns that this could prevent them from accessing information. The additional step of scanning a QR code to view medicine information could be cumbersome and reduce people’s willingness to use the e-labeling. Paper leaflets were valued for their immediate accessibility, as they were available immediately after opening the drug container.

Paper leaflets are convenient and available right out of the box. Why would I go through the trouble of searching on my phone? I wouldn’t use my phone to look up information more than I already do with paper leaflets. (P12, 50s, antihypertensive e-labeling group)

On the other hand, some participants expected e-labeling would reduce the need for storing printed copies of drug leaflets. For example, when using non-prescription medicines, patients often discard the paper package inserts; however, if a QR code is on the container or packaging, they could retrieve the drug information without relying on paper leaflets. Another reported advantage was the ability to download and save e-labeling on mobile phones, which enabled access to drug information anytime and anywhere. The summary of qualitative findings on e-labeling are presented in Table 5.

When I open the medicine packaging, I sometimes throw away the paper leaflets right away. Sometimes, the leaflets are wrinkled, dirty, or torn, making them difficult to read. I might even lose them. In that case, I think it would be nice to be able to look up the information I want on my phone. (P7, 20s, NSAID e-labeling group)

Table 5 Summary of Qualitative Findings on E-Labeling

Patient Preferences and Conditions for Successful E-Labeling Adoption

When considering the advantages and disadvantages of paper leaflets and e-labeling, most participants expressed a clear preference for a hybrid approach that incorporates both formats. They emphasized that offering both options would maximize usability and ensure that patients can choose the format that best meets their needs. However, if the national policy mandates a single delivery method, participants strongly advocated the retention of paper package leaflets to ensure availability of drug information through an existing and familiar format.

If there is a paper leaflet that is also available online, I’d prefer that. However, if the government gets rid of all the paper leaflets, the elderly won’t understand it, no matter how much you explain it. Many people still have difficulty using QR codes. Also, the elderly take more medication. I think e-labeling is too hard for them. (P20, 20s, NSAID e-labeling group)

Even participants who were optimistic about using e-labeling, either in combination with paper leaflets or alone, emphasized the need for improvements to enhance the usefulness of e-labeling. Several improvements were suggested to maximize the benefits of e-labeling. The improvements can be summarized into four: (1) formatting important information in a way that makes it easier to find and understand; (2) creating a table of contents and executive summary; (3) enhancing readability through visual elements such as color and images, which are less feasible in print due to cost, and (4) providing additional information, such as via hyperlinks and videos, to help people understand the content. Participants agreed that simply transferring the current paper leaflet content and format to the e-labeling would not be beneficial and could reduce their usage. They said e-labeling needs to be improved to make it easier to identify important information quickly. Solutions include highlighting important information with color, underlining or bolding, increasing the font size of certain information, or putting important information at the front of the leaflet. While the definition of “important information” may vary, typical examples include warnings, dosage instructions, and contraindications.

Why don’t they just make the information that they are legally required to provide and that people are asking for bigger and readily available? It would be less bulky, and they could create a separate online link for people who want to go into more detail. (P15, 40s, NSAID e-labeling group)

Participants suggested the creation of a table of contents and executive summary for ease of understanding the structure of the entire leaflet. Since e-labeling makes it harder to view the document’s overall layout at a glance, improving the format is essential. Suggestions included placing the table of contents at the beginning of the leaflet and incorporating digital features that would allow users to jump directly to the information they need, making the search process faster and more efficient.

I would like to utilize links to get the information I am looking for quickly. For example, suppose I want to find the precautions for specific situations while taking medicines. In that case, I can search and click the words I am looking for and gather the relevant information faster. (P17, 40s, NSAID paper leaflet group)

Finally, some commented that it would be helpful to have the ability to view additional information that cannot be provided in the leaflets via hyperlinks or videos. For example, they expressed a desire to click on a complicated term in the leaflet to see a further explanation or a direct link to a video to watch an expert explain a drug or disease in detail. In addition, e-labeling can be made more patient-friendly by using various techniques to improve readability—such as the use of color and images—without concerns about the cost limitations associated with printed materials. By actively utilizing these technological advantages enabled by digital platforms, it becomes possible to overcome the inherent limitations of paper leaflets and offer more user-centered and accessible drug information.

Discussion

In this study, we used user testing, as recommended by the European Commission,¹⁶ to assess the readability and usability of package leaflets in both paper and electronic formats. According to the European guideline,¹⁶ a package leaflet is considered readable when 90% of the participants can locate the information, and 90% of them understand it. However, the paper leaflets for both drugs failed to meet this standard, and e-labeling demonstrated even lower performance in terms of traceability, tracking speed, and comprehension. Qualitative feedback from participants revealed several shortcomings. Many found it difficult to locate key information in paper leaflets due to technical jargon, poor visual layout, and an unclear information hierarchy. In the case of e-labeling, the need to zoom in to read small text often disrupted their ability to grasp the overall structure of the leaflet. These findings indicate that current package leaflets in South Korea are not adequately tailored to patients’ needs and comprehension levels, and thus require improvements in both content and format before fully transitioning to e-labeling.

The poor performance of e-labeling observed in the user testing is likely due to the inherent limitations of its current structure and use, as revealed in our qualitative findings. Participants reported difficulties in grasping the overall structure of the document at a glance and expressed uncertainty about whether the information they found was relevant to their needs. When users relied on zoom-in and zoom-out functions to navigate the document, they often lost the contextual understanding necessary for accurate interpretation of the information. Even when using the search function, participants found it challenging to determine which search result was most relevant, especially when similar information appeared in multiple sections of the leaflet, such as when adverse effects or precautions were repeated. Interview data further revealed that participants frequently revisited the surrounding context of the information they found to confirm its relevance, resulting in slower tracking speeds and, in many cases, either failing to find the answer or failing to fully comprehend it once found. Although users could enlarge the text, the small font size on mobile phones, combined with complex terminology throughout the leaflet, significantly hindered readability and further limited the practical usability of e-labeling. Being “dropped into” a specific point in the e-labeling via keyword search without sufficient orientation or guidance often left them confused and unable to use the information effectively. Previous studies have found that even younger adults report concerns about e-labeling, often related to difficulties in navigating digital formats.^12,13 Our findings support these previous studies, emphasizing that concerns about e-labeling are not primarily due to resistance to digital formats themselves, but rather arise from practical barriers, such as insufficient guidance on how to access and use the information, a lack of intuitive navigation, and poorly organized layouts.^12,22

While previous studies have quantitatively demonstrated mixed public attitudes toward e-labeling,^12,13 our study also highlights valuable qualitative insights, particularly regarding accessibility. Participants valued the potential convenience of e-labeling, particularly the ability to access information anytime and anywhere without relying on paper leaflets. However, others expressed concern that removing paper leaflets, which are considered the most intuitive and familiar format, could make it more challenging to obtain the necessary drug information. Notably, participants considered not only themselves but also expressed concern for others, particularly older adults and individuals with limited digital skills, who might struggle to access information in digital formats. This broader perspective contributed to their reluctance to support a nationwide transition to e-labeling. These findings highlight that for e-labeling to be successfully implemented, it must ensure universal accessibility and demonstrate clear advantages over existing paper leaflets in terms of readability and usability.

It is essential to avoid simply converting paper package leaflets into digital formats such as PDFs to maximize the benefits of e-labeling, as seen in the case of South Korea. Instead, the focus should shift toward optimizing digital delivery formats by utilizing features such as intuitive navigation, structured content, interactive functions, and customization options.²³ In particular, introducing a “key information” section, which can help patients quickly locate key information, has been discussed as a strategy to enhance user comprehension, though implementation challenges such as standardization and regulatory burden remain.²⁴ Furthermore, our study identified several desired features suggested by participants, such as headline sections, color, pictograms, hyperlinks, videos, and customized leaflets for patients. These features are supported by previous literature for their effectiveness in improving information accessibility and understanding,^25–28 underscoring the importance of integrating them into future e-labeling formats. Overall, patient-centered approaches are crucial to ensure that e-labeling effectively serves its intended purpose of enhancing access and understanding across diverse user populations.

Implications for Policy and Practice

As of 2023, South Korea has one of the most advanced digital infrastructures globally, with household internet access reaching 99.9%,²⁹ a smartphone penetration rate of 94.8%,³⁰ and high rates of device ownership even among older adults (e.g., 96.2% in the 60s).³⁰ The household internet penetration rate stands at 82.5%, and computer ownership at 78.1%, indicating widespread digital access across the population.³¹ These conditions help explain the government’s recent decision to implement a national e-labeling system using QR codes. However, while there is substantial policy interest in expanding digital accessibility, comparatively less attention has been given to improving e-health literacy and users’ ability to engage with health-related information.³² National surveys reveal substantial disparities in digital health literacy across different subpopulations,³³ particularly among older adults and other information-vulnerable groups.^34–36 Without targeted interventions to address these gaps, the shift to e-labeling may inadvertently limit access to essential medicine information and exacerbate health inequities.

Unlike the European Union, where user testing is an established component of the regulatory process, South Korea currently lacks such a requirement.³⁷ Moreover, while countries that have adopted e-labeling—such as Japan and Singapore—do not mandate user testing, they have made efforts to develop patient-targeted package leaflets. In contrast, South Korea has yet to establish practices for designing package leaflets tailored to patient needs, indicating a clear area for improvement. As e-labeling advances, there is a growing need not only to evaluate the readability and usability of digital materials through user testing, but also to assess user acceptance—whether patients from diverse backgrounds can and are willing to engage with digital formats. In this context, developing patient-centered content and verifying its acceptability and usability through real-world testing will be critical. Reflecting these considerations, several countries have initially limited e-labeling to hospital-only medicines,³⁸ which are dispensed and administered in controlled settings under the supervision of healthcare professionals. Expansion to non-prescription products is still considered premature by many experts,³⁹ highlighting the need for careful regulatory planning and staged implementation. Therefore, the transition from paper leaflets to e-labeling should proceed gradually, guided by empirical evidence and continuous feedback from various stakeholders. Several policy considerations must be addressed to support the effective implementation of e-labeling. First, e-labeling should be introduced gradually, starting with medicines that are administered and monitored by healthcare professionals, such as injectable drugs, while maintaining printed leaflets for self-administered medicines. Second, to ensure equitable access, healthcare systems must establish mechanisms that allow patients with limited digital literacy to obtain printed leaflets at no cost upon request. Third, e-labeling must be grounded in patient-centered principles, providing intuitive interfaces and leveraging digital tools to maximize its benefits. Its effectiveness should be validated through real-world pilot studies. Lastly, comprehensive education and awareness campaigns targeting both patients and healthcare professionals are crucial for promoting an understanding of the purpose and benefits of e-labeling. These efforts should also include practical guidance on how to use e-labeling and aim to promote its acceptance in every healthcare practice. Such an approach is essential to ensure that e-labeling enhances—not hinders—access, comprehension, and the safe use of medicines across all patient groups.

Strengths and Limitations

To the best of our knowledge, this is the first to assess the actual use of e-labeling by patients through user testing, a method widely recognized as valuable in the European regulatory review process. While several studies have evaluated the acceptance and expectations of e-labeling, our study provides in-depth insights into the barriers that may hinder its use and accessibility. By identifying key factors necessary for the effective implementation of e-labeling, we aim to support future initiatives. Additionally, there are few studies that apply user testing in countries where English is not the native language, making our findings even more significant. The results of this study will be beneficial for countries with diverse regulatory frameworks that plan to introduce e-labeling policies in the future.

This study has some limitations. First, the user testing method employed in this study to evaluate the leaflets was initially designed to assess the readability of paper leaflets and was not specifically designed for e-labeling. However, the strength of this approach lies in its ability to gather both quantitative and qualitative data, providing a comprehensive evaluation of how patients actually use the leaflets, which is the primary objective of the study.^40–42 Second, participants’ education levels differed slightly from those of the general population. In South Korea, approximately 50.7% of individuals graduated from university in 2020.⁴³ In contrast, the percentage of participants who graduated from university ranged from 33.3% to 80.0%, which may have influenced the study’s outcomes. Third, e-labeling was evaluated by scanning a QR code on the container and packaging with participants’ mobile phones to view PDF files of the leaflets. However, the readability of e-labeling might vary depending on the electronic devices or platforms used for information delivery. Despite this variability, the approach used in this study is consistent with the current practices in South Korea’s e-labeling pilot studies and may represent the most practical way to implement e-labeling. Lastly, the generalizability of the findings may be limited, as the study was conducted in a single, conveniently selected region (Goyang-si), focused solely on the antihypertensive and NSAID, and involved a relatively small sample size.

Implications for Future Research

Future studies should recruit larger and more diverse populations, include a broader range of therapeutic categories, and be conducted across multiple geographic regions to enhance the generalizability of findings. Specifically, quantitative research that identifies factors influencing the use and acceptance of e-labeling, along with subgroup analysis based on participant characteristics, would provide deeper insights into information-seeking behaviors related to e-labeling. Future studies should also explore the perspectives of other stakeholders, including healthcare professionals, the pharmaceutical industry, and regulators. For instance, physicians, pharmacists, and nurses may have different views on the value, feasibility, and clinical utility of e-labeling. The economic implications of e-labeling also deserve further investigation. While pharmaceutical companies may save costs by eliminating paper leaflets, these savings may be negated by increased expenses in other areas of the healthcare system, such as pharmacies, where printed leaflets might still be necessary to ensure equitable access upon patient requests.²⁴ Therefore, future research should examine the broader systemic impacts of e-labeling adoption.

Conclusion

This study presents patient-centered evidence indicating that current medicine package leaflets in South Korea, whether in paper or electronic format, do not adequately ensure readability and usability for patients. While e-labeling may offer some potential advantages, it does not inherently enhance readability and usability. To facilitate the successful adoption of e-labeling, improvements in content formatting, navigation structure, equitable access mechanisms, and the use of digital features are essential prerequisites. Stakeholders must understand that e-labeling is not just a technological transition; it is also a patient communication strategy that requires careful design and validation. Pilot implementation, supported by real-world testing and feedback from multiple stakeholders, will be crucial for the effective adoption of e-labeling and for promoting safe medicine use in the digital era. Patients also need practical guidance on how to use e-labeling, along with educational and awareness campaigns led by healthcare professionals and pharmaceutical companies. Regulators should ensure that no patients are left behind in the era of e-labeling and maintain their commitment to safeguarding public health.

Data Sharing Statement

The study data are not available as the participants have not provided consent for the data to be made available beyond the research team. Furthermore, the research team only has the participants’ consent to publish de-identified group data.

Acknowledgments

The authors would like to thank all study participants for their time and contributions.

Author Contributions

All authors made substantial contributions to conceptualization, study design, data acquisition, analysis, and interpretation of data; drafted or revised the article; agreed on the journal to which the article was submitted; gave final approval of the version to be published; and committed to being accountable for all aspects of the work.

Funding

The study reported in this publication was supported by grants 22183MFDS368 and RS-2024-00332213 from the Ministry of Food and Drug Safety in 2025. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Ministry of Food and Drug Safety.

Disclosure

The authors report no conflicts of interest in this work.

References

1. Pires C, Vigário M, Cavaco A. Readability of medicinal package leaflets: a systematic review. Rev Saude Publica. 2015;49:4. doi:10.1590/S0034-8910.2015049005559

2. Raynor DK, Blenkinsopp A, Knapp P, et al. A systematic review of quantitative and qualitative research on the role and effectiveness of written information available to patients about individual medicines. Health Technol Assess. 2007;11(5):1–160. doi:10.3310/hta11050

3. Bolislis WR, de Lucia ML, Dolz F, et al. Regulatory agilities in the time of COVID-19: overview, trends, and opportunities. Clin Ther. 2021;43(1):124–139. doi:10.1016/j.clinthera.2020.11.015

4. Matsui R, Yamaguchi K, Lee JJV, et al. Survey result for E-labeling initiatives in Asia. Ther Innov Regul Sci. 2023;57(2):251–260. doi:10.1007/s43441-022-00462-5

5. Bolislis WRR, Mortazavi C, Riccioni R, et al. From print to screen: regulatory considerations to adopting innovative approaches for patient information and safety. Ther Innov Regul Sci. 2020;54(4):831–838. doi:10.1007/s43441-019-00018-0

6. Roberts K, Thakkar R, Autor D, et al. Creating E-Labeling platforms: an industry vision. Clin Pharmacol Ther. 2020;108(4):716–718. doi:10.1002/cpt.1865

7. Pharmaceuticals and Medical Devices Agency (PMDA). Information regarding newly introduced electronic package inserts. Available from: https://www.pmda.go.jp/english/safety/info-services/e-pack-ins/0001.html. Accessed March 16, 2025.

8. Health Sciences Authority (HSA). Guidance on electronic labelling for therapeutic products. Available from: https://www.hsa.gov.sg/docs/default-source/hprg-tpb/guidances/tpb-gn-021-000_appendix-7a-guidance-on-electronic-labelling-for-therapeutic-products.pdf?sfvrsn=1f3ad3d0_6. Accessed March 13, 2025.

9. European Medicines Agency (EMA). Electronic product information for human medicines in the EU: key principles. Available from: https://www.ema.europa.eu/en/news/key-principles-use-electronic-product-information-eu-medicines. Accessed March 14, 2025.

10. European Medicines Agency (EMA). Electronic product information (ePI). Available from: https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/product-information-requirements/electronic-product-information-epi. Accessed March 16, 2025.

11. Pharmaceutical Affairs Act (Act No. 19897). Law.go.kr. Available from: https://www.law.go.kr/lsInfoP.do?lsiSeq=257861&ancYd=20240102&ancNo=19897&efYd=20240102&nwJoYnInfo=N&efGubun%20=Y&chrClsCd=010202&ancYnChk=0. Accessed March 16, 2025.

12. Hammar T, Nilsson AL, Hovstadius B. Patients’ views on electronic patient information leaflets. Pharm Pract. 2016;14(2):702–710. doi:10.18549/PharmPract.2016.02.702

13. Bamberger M, De Loof H, Marstboom C, et al. Replacing vaccine paper package inserts: a multi-country questionnaire study on the acceptability of an electronic replacement in different target groups. BMC Public Health. 2022;22(1):156. doi:10.1186/s12889-022-12510-8

14. Bechini A, Chiesi F, Giammarco B, et al. Electronic package leaflets for vaccines: what are people’s perceptions in Italy? Vaccines. 2022;10(7):1075. doi:10.3390/vaccines10071075

15. Sless D, Shrensky R. Writing About Medicines for People. Sydney: Australian Self-Medication Industry; 2006.

16. European Commission. Guideline on the readability of the labelling and package leaflet of medicinal products for human use. Available from: https://health.ec.europa.eu/system/files/2016-11/2009_01_12_readability_guideline_final_en_0.pdf. Accessed March 16, 2025.

17. Raynor DK. User testing in developing patient medication information in Europe. Res Social Adm Pharm. 2013;9(5):640–645. doi:10.1016/j.sapharm.2013.02.007

18. Kim SJ, Kwon OD, Cho B, et al. Effects of combination drugs on antihypertensive medication adherence in a real-world setting: a Korean Nationwide Study. BMJ Open. 2019;9(6):e029862. doi:10.1136/bmjopen-2019-029862

19. Ministry of Food and Drug Safety (MFDS). Trends in reporting of safety information on medicines in 2020. Available from: https://nedrug.mfds.go.kr/bbs/2/57/. Accessed March 16, 2025.

20. Kim DJ. The user readability test of package inserts on oral contraceptives in Korea [master’s thesis]. Seoul: Chung-Ang University; 2009.

21. Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005;15(9):1277–1288. doi:10.1177/1049732305276687

22. Loh XY, Woo AL, Haris A, et al. Acceptance of electronic labeling for medicinal product information among Malaysian hospital patients: cross-sectional study. J Med Internet Res. 2024;26:e56591. doi:10.2196/56591

23. Sirkas K, Juppo A, Miettinen M, et al. Could paper package leaflets be left out from hospital products? Explor Res Clin Soc Pharm. 2022;26(7):100176. doi:10.1016/j.rcsop.2022.100176

24. European Federation of Pharmaceutical Industries and Associations (EFPIA). Position papers on electronic product information (ePI). Available from: https://www.efpia.eu/media/2sgl2zyh/iatf-position-papers-on-epi.pdf. Accessed March 16, 2025.

25. Dickinson R, Raynor DK, Knapp P, et al. Do patients use a headline section in a leaflet to find key information about their medicines? Findings from a user-test study. Ther Innov Regul Sci. 2016;50(5):581–591. doi:10.1177/2168479016639080

26. Shrestha A, Rajesh V, Dessai SS, et al. Preparation, validation and user-testing of pictogram-based patient information leaflets for tuberculosis. Pulm Pharmacol Ther. 2018;51:26–31. doi:10.1016/j.pupt.2018.05.002

27. van den Berg LN, Chavannes NH, Aardoom JJ. Using animated videos to promote the accessibility and understandability of package leaflets: retrospective observational study evaluating the first year of implementation. J Med Internet Res. 2023;25:e40914. doi:10.2196/40914

28. Munsour EE, Awaisu A, Ahmad Hassali MA, et al. Impact of customized-consumer medication information on health-related quality of life among patients with type 2 diabetes mellitus. Res Social Adm Pharm. 2020;16(6):793–799. doi:10.1016/j.sapharm.2019.08.038

29. OECD. ICT access and usage by households. Available from: https://data-explorer.oecd.org/vis?tm=DF_HH&pg=0&snb=1&vw=tb&df[ds]=dsDisseminateFinalDMZ&df[id]=DSD_ICT_HH_IND%40DF_HH&df[ag]=OECD.STI.DEP&df[vs]=&pd=2012%2C&dq=.A.B1_HH._T._T.&to[TIME_PERIOD]=false. Accessed March 16, 2025.

30. Korea Communications Commission (KCC). 2023 Survey on media usage behavior. Available from: https://kcc.go.kr/user.do?mode=view&page=A02060100&dc=K02060100&boardId=1027&cp=1&boardSeq=59157. Accessed February 23, 2025.

31. Ministry of Science and ICT (MSIT). MSIT announces 2022 survey result on digital divide. Available from: https://www.msit.go.kr/eng/bbs/view.do?sCode=eng&mId=4&mPid=2&pageIndex=&bbsSeqNo=42&nttSeqNo=782&searchOpt=ALL&searchTxt=. Accessed March 16, 2025.

32. Choi SK, Chun H, Choi EJ. Review of recent digital health literacy programs in Europe and the United States. Korean J Health Educ Promot. 2022;39(4):15–28. doi:10.14367/kjhep.2022.39.4.15

33. Ministry of Science and ICT (MSIT). The report on the digital divide in 2023. Available from: https://www.msit.go.kr/bbs/view.do?sCode=user&mId=99&mPid=74&bbsSeqNo=79&nttSeqNo=3173616. Accessed November 30, 2024.

34. Kim M, Lee J, Doo EY. Factors influencing healthcare provider-patient communication of patients with chronic diseases. J Korean Acad Nurs Adm. 2020;26(2):73–83. doi:10.11111/jkana.2020.26.2.73

35. Kim HJ, Kim M. Comparison study of e-health literacy and health promoting behaviors of cancer patients and nurses. Asian Oncol Nurs. 2020;20(2):100–109. doi:10.5388/aon.2020.20.2.100

36. Song JH, Shin SJ. The effects of e-health literacy and subjective health status on health-seeking behaviors of elderly using the Internet in the community. J Digit Converg. 2020;18(1):321–332. doi:10.14400/JDC.2020.18.1.321

37. Yang JW, Kwon KH. A comparative analysis on common technical document module 1 submission form of drug labeling in South Korea, United States and Europe. Yakhak Hoeji. 2023;67(6):404–414. doi:10.17480/psk.2023.67.6.404

38. Skogman-Lindqvist C, Lapatto-Reiniluoto O, Sirviö M, et al. Benefits and challenges of electronic package leaflet (ePL) – review of ePL pilots in hospital settings in Europe. Eur J Pharm Sci. 2023;191:106605. doi:10.1016/j.ejps.2023.106605

39. Lambot N, Vande Ginste M. Electronic leaflet pilot in Belgium and Luxembourg hospitals. Regulatory Rapporteur. 2022;19(4):3–5.

40. Jay E, Aslani P, Raynor DK. User testing of consumer medicine information in Australia. Health Educ J. 2011;70(4):420–427. doi:10.1177/0017896910376131

41. Tong V, Raynor DK, Aslani P. User testing as a method for identifying how consumers say they would act on information related to over-the-counter medicines. Res Social Adm Pharm. 2017;13(3):476–484. doi:10.1016/j.sapharm.2016.06.001

42. Tong V, Aslani P, Raynor DK, et al. Developing and user testing new pharmacy label formats – a study to inform labelling standards. Health Expect. 2021;24(4):1125–1136. doi:10.1111/hex.13203

43. OECD. Education at a glance 2024. Available from: https://www.oecd.org/en/publications/education-at-a-glance-2024_c00cad36-en.html. Accessed March 16, 2025.

Introduction

Chronic heart failure (CHF) is a prevalent chronic progressive disease among the elderly, characterized by high morbidity, hospitalization rates, and mortality, posing a significant threat to patients’ health and quality of life.¹ While substantial efforts have focused on pharmacological and device-based interventions, increasing attention has been directed to the role of patient self-management in delaying disease progression and reducing adverse outcomes.² Self-management, defined as a patient’s ability to monitor symptoms, adhere to medications, and adjust lifestyle behaviors, is considered a cornerstone of heart failure care. Effective self-management can reduce the risk of acute exacerbations and hospital readmissions.³ Despite growing evidence of its clinical value, self-management in elderly CHF patients is often suboptimal due to age-related functional and cognitive decline, which impairs their ability to execute key daily tasks. Task performance, in this context, refers to a patient’s actual ability to carry out disease-specific management behaviors, which include weight monitoring, identifying high-salt diets, detecting edema, and adjusting medications. Inadequate Task Performance may lead to delayed disease progression, resulting in poorer health outcomes, including higher rehospitalization rates and increased mortality risk.⁴ Importantly, Task Performance may also be reflected in key heart failure biomarkers, such as NT-proBNP (N-terminal pro-B-type natriuretic peptide) and uric acid, which are widely used in clinical practice to assess disease severity, predict acute episode risks, and monitor treatment efficacy⁵ (Nair & Gongora, 2018). For instance, elevated NT-proBNP levels are often correlated with worsening heart failure symptoms and may indicate greater challenges in self-management tasks.⁶ Similarly, abnormal uric acid levels may be linked to heart failure-related cardiac dysfunction,⁷ offering valuable biological insights into patients’ task execution abilities and disease management.

Despite the increasing body of research emphasizing the importance of self-management abilities and heart failure biomarkers individually, the association between them remains unclear. Therefore, this study aims to investigate the correlation between self-management Task Performance and heart failure biomarkers in elderly CHF patients, with the goal of providing evidence to enhance patient self-management and clinical intervention strategies. The significance of this study lies in quantifying self-management Task Performance and integrating it with heart failure biomarkers, potentially offering new perspectives and theoretical support for personalized interventions in elderly CHF patients. This approach could further optimize chronic disease management, improve patient quality of life, reduce medical costs, and provide theoretical support for the development of more precise clinical management measures.

Materials and Methods

Study Design and Participants

This study employed a convenience sampling method to recruit elderly patients with CHF hospitalized in the cardiology departments of two tertiary hospitals in Zhejiang Province between August and December 2024. All eligible patients were diagnosed with CHF based on the European Society of Cardiology (ESC) criteria and had been diagnosed for at least three months. The inclusion criteria were as follows: (1) aged ≥60 years; (2) previously hospitalized for CHF; (3) clear consciousness and ability to complete questionnaire assessments and task execution evaluations; (4) willingness and ability to manage their disease independently. Exclusion criteria included: (1) requiring assistance in performing three or more basic activities of daily living (bathing, dressing, transferring from a chair, using the toilet, feeding, and grooming) before admission; (2) Moderate to severe cognitive impairment, defined as a Chinese Mini Mental Status Examination (CMMSE) score below education-adjusted cutoffs (<17 for illiterate, <20 for primary school, <24 for junior high or above; (3) patients transferred from nursing homes, as they are typically not responsible for their own self-care or treatment management.

The required sample size was estimated using Kendall’s formula, which suggests a sample size of 5 to 10 times the number of independent variables in the questionnaire. This study included seven demographic variables and six variables derived from the Task Performance scale, leading to a total of 13 independent variables. Considering a 10% rate of invalid questionnaires, the minimum required sample size was 71 participants. Ultimately, 103 participants were enrolled in the study. All participants provided informed consent before enrollment. The study was approved by the Ethics Committee of Sir Run Run Shaw hospital, Zhejiang University School of Medicine; and was conducted in accordance with the principles outlined in the Declaration of Helsinki.

Study Variable

Baseline data were collected using a structured questionnaire developed by the research team. Data collection was performed by trained research nurses or physicians. The following variables were recorded: (1) Demographic and Sociodemographic Characteristics: Sex, age, marital status, living situation, education level, economic burden, and smoking history. (2) Body composition and Clinical Characteristics: Body weight, body mass index (BMI), baseline blood pressure, and New York Heart Association (NYHA) functional classification. The presence of chronic comorbidities, including hypertension and diabetes mellitus, was documented. (3) Laboratory Biomarkers: Serum levels of NT-proBNP, C-reactive protein (CRP), white blood cell count (WBC), hemoglobin, uric acid, and glycated hemoglobin (HbA1c) were collected from laboratory reports. (4) Echocardiographic Parameters: Left ventricular ejection fraction (LVEF) was assessed through echocardiography. All variables were extracted from patients’ medical records at admission. These parameters were selected based on their relevance in assessing heart failure severity, self-management capacity, and clinical outcomes.

Task Performance Assessment

Self-management Task Performance was evaluated using a validated six-task assessment scale developed by Vidan et al⁴ specifically designed for CHF patients. This tool was developed by a multidisciplinary team of cardiologists, geriatricians, and nursing experts in heart failure management. The scale comprises simple, reproducible tasks with good feasibility, and its internal consistency reliability (Cronbach’s α coefficient) was reported as 0.58. In the preliminary assessment phase of this study, evaluations were conducted independently by both the head nurse and a specialized heart failure nurse, yielding an intra-class correlation coefficient of 0.88 (95% CI: 0.76–0.97), ensuring inter-rater reliability.

The six tasks assessed were: (I) Standing on a scale independently until a stable weight measurement was obtained and Reading and writing the measured weight correctly. (II) Recording of inputs and outputs correctly. (III) Identifying the prescribed diuretic from a medication box containing the patient’s regular CHF medications. (IV) Recognizing high-salt foods to be avoided from a standardized list, which included cheese, cured ham, salty snacks, olives, boiled rice, apples, and canned food. (V) Performing a self-examination of both ankles and correctly identifying the presence or absence of edema. (VI) Adjusting the prescribed diuretic dose based on a predefined rule according to weight changes, as stated in the patient’s medical records. For standardization, all patients were provided with the same type of weighing scale to ensure consistency in weight measurement. Medication boxes were shown to patients to facilitate diuretic identification. The high-salt food recognition task was assessed using standardized food images. The edema assessment required patients to physically examine their ankles and report whether swelling was present. Diuretic dose adjustment was evaluated based on the standard written guidelines recorded in the patient’s medical documentation. Each correctly completed task was scored as 1 point, whereas failure to complete or requiring assistance was scored as 0 points. The total score ranged from 0 to 6, with higher scores indicating greater Task Performance in self-management. To facilitate interpretation and comparability, the raw score was converted to a percentage scale using the formula: (total score / 6) × 100. This standardization allowed the Task Performance to be expressed on a 0–100 scale, with higher values representing better performance. This assessment provided an objective measure of CHF patients’ self-management execution ability, allowing for further analysis of its correlation with clinical outcomes.

Data Collection and Quality Control

To ensure data accuracy and reliability, all research personnel underwent standardized training before data collection. Screening of eligible CHF patients was conducted in collaboration with ward nurses. Data were collected following informed consent procedures. Baseline clinical assessments, including blood pressure and body weight, were completed within 24 hours of admission. Laboratory biomarkers, including NT-proBNP, C-reactive protein, white blood cell count, hemoglobin, uric acid, glycated hemoglobin, and left ventricular ejection fraction, were obtained from the first laboratory tests performed upon admission. Self-management Task Performance assessments were conducted by a specialized heart failure nurse using the validated six-task scale. NYHA functional classification was recorded at the time of Task Performance assessment. To ensure inter-rater reliability, a preliminary assessment was conducted in the first 10 patients. Both the head nurse and a specialized heart failure nurse performed independent evaluations to compare scoring consistency. Inter-observer agreement was analyzed, and adjustments were made as needed to optimize feasibility and validity in the study population.

Statistical Analysis

Statistical analyses were performed using SPSS 26.0 and RStudio 2024. Categorical variables were presented as frequencies and percentages. Continuous variables with a normal distribution were expressed as mean ± standard deviation (SD), while non-normally distributed continuous variables were reported as median and interquartile range (M [P25, P75]). The normality of continuous variables was assessed using the Shapiro–Wilk test. Comparisons between groups were conducted using independent samples t-tests for normally distributed continuous variables, and Mann–Whitney U-tests for non-normally distributed continuous variables. Chi-square tests or Fisher’s exact tests were applied to analyze categorical variables. Differences among multiple stratified groups were assessed using the Kruskal–Wallis H-test. Partial correlation analysis was conducted to assess the association among age, Task Performance, and NT-proBNP levels, adjusting for potential confounders such as sex and education level. In addition, bivariate Spearman correlation analysis was performed to examine the associations between individual task performance items, uric acid, and NT-proBNP levels, as illustrated in Figure 1. A restricted cubic spline (RCS) analysis was applied to assess the trend of Task Performance changes with age and to identify potential inflection points. The number of knots and boundary percentiles was determined according to Akaike Information Criterion (AIC) and visual inspection. Data visualization was conducted using the ggplot2 package in R, generating scatter plots and trend curves to illustrate the relationship between Task Performance and heart failure biomarkers such as NT-proBNP and uric acid. Fitted curves were used to further validate the observed correlations. All statistical tests were two-tailed, with a significance level set at P < 0.05.

Results

Baseline Characteristics

A total of 103 elderly patients with chronic heart failure (CHF) were included in the study. Based on the median Task Performance score (16.7), participants were classified into two groups: low Task Performance (<16.7, n=57) and high Task Performance (≥16.7, n=46). Patients in the high Task Performance group were significantly younger than those in the low execution ability group (p < 0.001). NYHA classification was also significantly associated with Task Performance (p = 0.005), with patients in the higher execution ability group demonstrating better functional status. NT-proBNP and uric acid levels were significantly lower in the high execution ability group (p = 0.01 and p = 0.006, respectively). There were no significant differences between the two groups in terms of sex, BMI, blood pressure, diabetes, hypertension, or other laboratory biomarkers (p > 0.05). See Table 1.

Table 1 Baseline Characteristics of Study Participants Stratified by Task Execution Ability

Task-Specific Performance in CHF Self-Management

Among the six evaluated self-management tasks, treatment adjustment had the lowest performance rate (8%), followed by diuretic identification (14%) and recording of inputs and outputs (18.7%). In contrast, oedema identification and salted food identification had the highest performance rates (41%), suggesting better patient awareness of dietary restrictions and fluid retention monitoring. These findings indicate that CHF patients struggle the most with medication management tasks, emphasizing the need for targeted interventions in this domain (Figure 2).

Figure 2 This bar chart illustrates the performance ability for six essential self-management tasks in patients with chronic heart failure (CHF). Each task is evaluated based on the percentage of patients who successfully completed it and the median [IQR] score for task execution.

Correlation Between Task Performance and Heart Failure Biomarkers

Partial correlation analysis revealed a significant negative correlation between Task Performance and NT-proBNP levels (r = −0.337, p < 0.001), suggesting that lower Task Performance is associated with higher NT-proBNP levels. Similarly, Task Performance was negatively correlated with uric acid levels (r = −0.279, p = 0.005), indicating that patients with poorer self-management ability exhibited higher uric acid levels. However, no significant correlation was observed between uric acid and NT-proBNP levels (r = 0.024, p = 0.404). The correlation matrix (Figure 1) further illustrated the relationships between specific self-management tasks and heart failure biomarkers. NT-proBNP was negatively correlated with several self-management tasks, including recording of inputs and outputs, oedema identification, and salted food identification, suggesting that higher NT-proBNP levels are associated with poorer task execution. Uric acid also showed a negative correlation with weight registration, indicating that higher uric acid levels may be related to difficulty in self-monitoring weight. These results emphasize the importance of Task Performance as a potential indicator of disease severity in CHF patients (Table 2 and Figure 1).

Table 2 Partial Correlation Analysis Between Uric Acid, Task Execution Ability, and NT-proBNP

Restricted cubic spline analysis demonstrated a downward trend in NT-proBNP and uric acid levels as Task Performance increased. Patients with lower execution ability exhibited substantially higher biomarker levels, particularly those with NT-proBNP exceeding 10,000 pg/mL. The trend stabilized at moderate-to-high execution ability levels, suggesting a non-linear relationship between self-management ability and biomarker levels. See Figure 3.

Figure 3 Trends of NT-proBNP (A) Levels Across Task Execution Ability. The plots display the relationship between task execution ability and biomarker levels using a smoothed trend line with a 95% confidence interval (shaded area). NT-proBNP and uric acid levels show a decreasing trend as task execution ability increases, indicating that patients with lower self-management performance tend to have higher biomarker levels. NT-proBNP, N-terminal pro-B-type natriuretic peptide (B) and Uric Acid.

Discussion

This study investigated the relationship between self-management task performance and heart failure biomarkers (NT-proBNP and uric acid) in elderly patients with CHF. Our findings suggest that patients with lower Task Performance exhibit significantly higher NT-proBNP and uric acid levels, indicating a potential link between self-management capacity and clinical outcomes in CHF patients. From a gerontological and pathophysiological perspective, functional and cognitive impairments may act as mediating factors in the relationship between aging and poor task performance, further limiting patients’ ability to engage in effective self-management. Studies have shown that cognitive impairment and physical frailty often coexist, leading to a compounded effect on functional decline. This dual burden significantly increases the risk of disability in activities of daily living (ADLs) and instrumental activities of daily living (IADLs), which are crucial for self-care.^8,9 Moreover, the presence of cognitive deficits in elderly CHF patients is independently associated with reduced ability to perform essential self-care tasks, such as medication management and recognizing symptoms of fluid overload.^4,10 This is compounded by the fact that many elderly patients with CHF lack the necessary skills for effective self-care, which correlates with higher mortality and readmission rates.⁴ The relationship between cognitive impairment and self-care difficulties underscores the need for comprehensive geriatric assessments that include evaluations of both cognitive and physical capacities to identify those at greatest risk for functional decline.^8,11

Moreover, Task Performance was negatively correlated with both NT-proBNP (r = −0.337, p < 0.001) and uric acid levels (r = −0.279, p = 0.005), suggesting that lower Task Performance is associated with higher biomarker levels. These findings are associative and do not imply causality, given the cross-sectional nature of our study design. Longitudinal or interventional research is warranted to evaluate whether improvements in self-management can lead to favorable changes in biomarker levels and patient outcomes.

Effective self-management is critical for improving prognosis and reducing hospital readmission in CHF patients.^12,13 However, our study revealed significant variability in patients’ ability to perform self-management tasks, with medication-related tasks (treatment adjustment and diuretic identification) having the lowest success rates (8% and 14%, respectively). These findings align with previous studies indicating that CHF patients often struggle with medication adherence and dosage adjustments due to cognitive decline, lack of health literacy, and insufficient patient education.¹⁴ Conversely, tasks related to oedema and dietary management (salted food identification, oedema identification) had relatively higher success rates, suggesting that patients are more aware of dietary restrictions and fluid retention monitoring than medication adjustments. This disparity underscores the need for targeted interventions to enhance medication self-management skills, particularly in elderly CHF patients.¹⁵

Our study revealed a significant inverse correlation between Task Performance and NT-proBNP levels (r = −0.337, p < 0.001), indicating that patients with diminished self-management proficiency exhibit more severe cardiac dysfunction. This finding aligns with previous research, which suggests that patients with elevated NT-proBNP levels are more prone to frequent exacerbations and hospitalizations, consequently impairing their capacity to perform self-care tasks.¹⁶ Furthermore, restricted cubic spline analysis revealed a non-linear relationship, with NT-proBNP levels decreasing as Task Performance improved, but stabilizing at moderate to high execution ability levels. This suggests that while better self-management can contribute to improved clinical outcomes, the complexity of managing CHF increases as the disease progresses, requiring a multifaceted approach that includes both medical interventions and substantial caregiver involvement. Caregivers play a crucial role in managing the daily needs of patients, which range from assisting with medication adherence to providing emotional support and coordinating healthcare appointments. The burden on caregivers can be substantial, impacting their physical, emotional, and financial well-being.¹⁷ Patients with advanced CHF may require additional medical and caregiver support to compensate for their functional limitations.

Similarly, uric acid has emerged as a relevant biomarker in CHF, with studies linking hyperuricemia to oxidative stress, endothelial dysfunction, and poor cardiovascular outcomes.⁷ In our study, uric acid levels were negatively correlated with Task Performance (r = −0.279, p = 0.005), particularly with weight registration, implying that patients with elevated uric acid levels struggle with weight monitoring. Hyperuricemia has been implicated in oxidative stress, endothelial dysfunction, and worse cardiovascular outcomes, and may serve as a marker of frailty. Patients with elevated uric acid may struggle with daily weight monitoring—a crucial behavior in early fluid retention detection. Prior research has also suggested that high uric acid levels are associated with reduced functional capacity and frailty in CHF patients,¹⁸ which may further impair their ability to manage their disease effectively.

The observed associations between Task Performance and heart failure biomarkers highlight the need for integrating self-management assessment into routine CHF care. Given that patients with lower execution ability have worse biomarker profiles, clinical interventions should prioritize enhancing self-care proficiency through structured educational programs, cognitive training, and caregiver involvement. To address these challenges, routine clinical assessments of task execution ability could be integrated into discharge evaluations or outpatient visits, particularly for elderly or high-risk patients. Standardized screening tools that capture both cognitive and functional dimensions of task performance may help clinicians identify individuals requiring additional support. Feasible implementation strategies include brief structured checklists, scenario-based evaluations, and interdisciplinary follow-up interventions combining education, caregiver involvement, and digital reminders. Such approaches may enable timely interventions, improve biomarker control, and ultimately enhance long-term outcomes in CHF populations. Additionally, since medication-related tasks posed the greatest challenge for patients, efforts should be made to simplify medication regimens, improve patient-provider communication, and incorporate digital health tools to support adherence.¹⁹ Future research should explore longitudinal associations between Task Performance and clinical outcomes²⁰ and examine whether improving execution ability through targeted interventions leads to better biomarker profiles and disease control. Moreover, further studies should investigate the role of cognitive function, social support, and psychological factors in influencing self-management performance in CHF patients.

Several limitations should be considered in interpreting our findings. First, this study used a cross-sectional design, limiting the ability to infer causality between Task Performance and biomarker levels. Second, self-management behaviors were assessed through direct task performance rather than real-world adherence, which may not fully capture patients’ long-term self-care behaviors. Third, the sample size was relatively small, and future studies with larger cohorts are needed to validate these findings and explore potential subgroup differences. Finally, the use of convenience sampling from two tertiary hospitals may introduce selection bias, limiting the generalizability of our results to broader CHF populations.

Conclusion

This cross-sectional study identified significant associations between lower task execution performance and elevated NT-proBNP and uric acid levels in elderly patients with chronic heart failure, suggesting that impaired self-management ability may reflect more severe disease status. The findings also revealed age-related decline in task performance, underscoring the vulnerability of older adults in managing complex heart failure regimens. Given the observational nature of this study, these results should be interpreted as associative rather than causal. Future research should employ longitudinal or randomized controlled designs to determine whether targeted interventions aimed at improving self-management performance can translate into improved biomarker profiles and clinical outcomes. Meanwhile, integrating routine assessments of task execution ability into heart failure care, especially for high-risk or cognitively impaired patients—may help identify those needing additional support and inform the development of individualized care strategies.

Data Sharing Statement

All data supporting the findings of this study are included in the article. No additional data are available.

Ethics Approval and Consent to Participate

The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. This study was conducted in accordance with the Declaration of Helsinki (as revised in 2013), and the study protocol was approved by the ethics committee of Sir Run Run Shaw hospital, Zhejiang university school of medicine (Approval No. 2024-Y0468). Additionally, this study was registered under the clinical record number MR-33-24-058353. Informed consent was obtained from all participants before survey initiation.

Acknowledgments

We sincerely acknowledge the study participants, without whose contributions this research would not have been possible. We are grateful to the Department of Cardiology in SRRSH, who participated in the survey design and data collection. We also gratefully acknowledge help from the anonymous referees and journal editors in the preparation of this manuscript.

Author Contributions

HX Z and XX H conceived and designed the study. HX Z organized project administration and drafted the manuscript, with critical revisions provided by RT W. JX C and JN D performed data analysis. YW contributed to the visualization by creating the figures. XX H, and YW were responsible for investigation and data curation. All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article, gave final approval of the version to be published, have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Funding

This work was supported by the Health Commission of Zhejiang Province Project in China (No.2024KY1100), and Nursing Research Project of Sir Run Run Shaw Hospital, Zhejiang University School of Medicine (2024HLKY01).

Disclosure

The authors have no conflicts of interest to declare.

References

1. Buda V, Prelipcean A, Cozma D, et al. An up-to-date article regarding particularities of drug treatment in patients with chronic heart failure. J Clin Med. 2022;11(7):2020. doi:10.3390/jcm11072020

2. Islam SMS, Nourse R, Uddin R, et al. Consensus on recommended functions of a smart home system to improve self-management behaviors in people with heart failure: a modified Delphi approach. Front Cardiovasc Med. 2022;9:896249. doi:10.3389/fcvm.2022.896249

3. Cavalcante AMRZ, Lopes CT, Brunori EFR, et al. Self-care behaviors in heart failure. Int J Nurs Knowl. 2018;29(3):146–155. doi:10.1111/2047-3095.12170

4. Vidán MT, Martín Sánchez FJ, Sánchez E, et al. Most elderly patients hospitalized for heart failure lack the abilities needed to perform the tasks required for self-care: impact on outcomes. Eur J Heart Fail. 2019;21(11):1434–1442. doi:10.1002/ejhf.1559

5. Nair N, Gongora E. Correlations of GDF-15 with sST2, MMPs, and worsening functional capacity in idiopathic dilated cardiomyopathy. J Circ Biomark. 2018;7:1849454417751735. doi:10.1177/1849454417751735

6. Lee CS, Moser DK, Lennie TA, et al. Biomarkers of myocardial stress and systemic inflammation in patients who engage in heart failure self-care management. J Cardiovasc Nurs. 2011;26(4):321–328. doi:10.1097/JCN.0b013e31820344be

7. Kumrić M, Borovac JA, Kurir TT, Božić J. Clinical implications of uric acid in heart failure: a comprehensive review. Life. 2021;11(1):53. doi:10.3390/life11010053

8. McGrath R, Vincent BM, Hackney KJ, et al. Weakness and cognitive impairment are independently and jointly associated with functional decline in aging Americans. Aging Clin Exp Res. 2019;31(3):327–334. doi:10.1007/s40520-018-0996-4

9. Thein FS, Li Y, Nyunt MSZ, et al. Physical frailty and cognitive impairment is associated with diabetes and adversely impact functional status and mortality. Postgrad Med. 2018;130(4):392–400. doi:10.1080/00325481.2018.1466968

10. Alosco ML, Spitznagel MB, Cohen R, et al. Cognitive impairment is independently associated with reduced instrumental activities of daily living in persons with heart failure. J Cardiovasc Nurs. 2011;26(2):114–122. doi:10.1097/JCN.0b013e3181ec8ae0

11. Andersson HI, Westgård T, Dahlin-Ivanoff S, et al. Frail older people with decreased cognition can perceive reduced self-determination in self-care and social relationships. BMC Geriatr. 2024;24(1):7. doi:10.1186/s12877-023-04492-y

12. Zhu H, Han X, Yang F, et al. Design and application of a self-management tool in patients with chronic heart failure. Chin J Nurs. 2023;58(12):1469–1475. doi:10.3761/j.issn.0254-1769.2023.12.009

13. Lancey A, Slater CE. Heart failure self-management: a scoping review of interventions implemented by allied health professionals. Disabil Rehabil. 2024;46(21):4848–4859. doi:10.1080/09638288.2023.2283105

14. Granata N, Torlaschi V, Zanatta F, et al. Positive affect as a predictor of non-pharmacological adherence in older chronic heart failure (CHF) patients undergoing cardiac rehabilitation. Psychol Health Med. 2023;28(3):606–620. doi:10.1080/13548506.2022.2077394

15. Kristinawati B, Wijayanti N, Mardana N. Improving medication adherence of patients with heart failure using tele-motivational interviewing. Eur Rev Med Pharmacol Sci. 2023;27(21):10171–10180. doi:10.26355/eurrev_202311_34293

16. Boesing M, Bierreth F, Abig K, et al. Effects of serial NT-proBNP measurements in patients with acute decompensated heart failure: results of the POC-HF pilot trial. Glob Cardiol Sci Pract. 2024;2024(4):e202431. doi:10.21542/gcsp.2024.31

17. Liljeroos MA, Miller JL, Lennie TA, Chung ML. Quality of life and family function are poorest when both patients with heart failure and their caregivers are depressed. Eur J Cardiovasc Nurs. 2022;21(3):220–226. doi:10.1093/eurjcn/zvab071

18. Doehner W, Rauchhaus M, Florea VG, et al. Uric acid in cachectic and noncachectic patients with chronic heart failure: relationship to leg vascular resistance. Am Heart J. 2001;141(5):792–799. doi:10.1067/mhj.2001.114367

19. Miao Y, Luo Y, Zhao Y, et al. Effectiveness of eHealth interventions in improving medication adherence among patients with cardiovascular disease: systematic review and meta-analysis. J Med Internet Res. 2024;26:e58013. doi:10.2196/58013

20. Tuena C, Borghesi F, Bruni F, et al. Technology-assisted cognitive motor dual-task rehabilitation in chronic age-related conditions: systematic review. J Med Internet Res. 2023;25:e44484. doi:10.2196/44484