As the final decade of acceleration towards zero new cases of Female Genital Mutilation  by 2030 has begun, increasing the rigour, relevance, and utility of research for programming, policy development and resource allocation is critical. This study aimed to synthesize and assess the quality and strength of existing evidence on interventions designed to prevent or respond to FGM between 2008 and 2020.The study drew on a Rapid Evidence Assessment of the available literature on FGM interventions. The quality of studies was assessed using the ‘How to Note: Assessing the Strength of Evidence’ guidelines published by the Foreign, Commonwealth and Development Office (FCDO) and strength of evidence using a modified Gray scale developed by the What Works Association. Of the 7698 records retrieved, 115 studies met the inclusion criteria. Of the 115 studies, 106 were of high and moderate quality and were included in the final analysis. This review shows that at the system level, legislation-related interventions must be multifaceted to be effective. Whilst all levels would benefit from more research, for the service level especially more research is needed into how the health system can effectively prevent and respond to FGM. Community-level interventions are effective for changing attitudes towards FGM, but more must be done to innovate with these interventions so that they move beyond affecting attitudes alone to creating behaviour change. At the individual level, formal education is effective in reducing FGM prevalence among girls. However, the returns of formal education in ending FGM may take many years to be realized. Interventions targeting intermediate outcomes, such as improvement in knowledge and change in attitudes and beliefs towards FGM, are equally needed at the individual level. Female genital mutilation (FGM) is a practice that “involves partial or total removal of the female external genitalia or other injury to the female genital organs for non-medical reasons” . The praOver the last decade (2010–2020), despite intensified efforts to conduct research globally on addressing FGM, the evidence-base of rigorous high-quality studies on interventions that are effective in ending the practice remains sparce and not well known. Knowledge of what works has remained elusive, partly due to the limited synergy between evidence on ending FGM and programme and policy implementation. The disconnect between research and programming is reflected in the inadequate uptake of evidence-based FGM findings to inform policy and programmes and to support mobilization of resources to end the practice. Moreover, much of the research conducted to date has not adequately engaged affected communities, key stakeholders , from the outset. Other reasons for the limited uptake of evidence include inadequate communication of evidence-based findings and insufficient support or budgets to utilize and operationalize research findings. In addition, inadequate monitoring and evaluation indicators and a lack of coordination between programme personnel and research practitioners in the sector has posed challenges for determining the effectiveness of FGM programmes, while also resulting in research agendas that are not well-aligned with programme needs . Yet, asA small number of publications have collated evidence on the effectiveness of interventions to end FGM, either through systematic or non-systematic reviews –15. SomeThe current review was designed to contribute to SDG target 5.3 of zero new cases of FGM by 2030 through strengthening the synergy between evidence generation and FGM programmes, as well as to inform a global research agenda for FGM , 18. In This review included available literature on FGM interventions from 2008–2020 . The eviA Rapid Evidence Assessment (REA) approach was used to conduct a comprehensive review of the available literature on FGM interventions . The REAThe inclusion criteria for the literature search were established a priori: the search included studies focussing on assessing the effectiveness of interventions in ending FGM published in Arabic, English or French, as either evaluation reports, peer-reviewed articles or student theses, regardless of location in the world. Moreover, in order to enable assessment of quality, studies needed to have clear methodologies.The key words used in the literature search were:  AND “interventions”. The systematic search of literature was conducted in the following scientific databases: EBSCO , JSTOR, Knowledge Commons, PubMed, SAGE journals, Web of Science and WILEY. Websites of institutions or organizations that have been involved in FGM work (n = 45) were purposively identified, according to prior knowledge of their work by the co-authors. We also used references in reports and other literature to identify institutions or organizations involved in FGM work. Additional literature was identified by searching references of retrieved studies and via suggestions from experts in the FGM field.Literature that met the inclusion criteria was categorized as either a primary or secondary study. Primary studies refer to research that observes a phenomenon first-hand, collects, analyses and/or presents raw data, while secondary studies refer to research that summarizes and interrogates primary study data and findings.The quality of primary studies was assessed based on the United Kingdom Department for International Development (DfID) ‘How To Note’ guidelines . Scores The quality of secondary studies was assessed based on scores (0–2) given to indicators aligning with 3 principles of quality: transparency, validity and reliability cfr. . A scoreData from studies that were graded as being of moderate or high quality were extracted using a pre-designed data extraction form, with columns for author/s name, the study title, year of publication, the study design, intervention description, study outcomes, reasons for success or failure of the intervention and study conclusions . Due to The strength of the evidence in these studies was evaluated using a modified Gray scale –24. Origsuccessful if supporting evidence includes four or more studies that are Gray IIIb or higher and have evidence of more than one country; as 2) promising when evidence includes three or fewer studies of any Gray level or two or more studies at Gray IIIb or higher but only from one country; and 3) as not working if four or more studies that are Gray IIIb or higher and have evidence from more than one country that the intervention does not work.To assess the strength of a body of evidence, criteria are set for the number of studies, the number of countries and the Gray scale ratings for each study. Interventions are described as 1) Quality assurance measures were applied at every step of the review, by guaranteeing researcher triangulation and consequently reducing bias in each step of the REA process: from screening studies to determine whether they met the inclusion criteria, over quality and strength assessment. A digital referencing tool, Zotero, was used to manage all bibliographic references. To screen studies, the Covidence online platform was used as it facilitates indication of duplicate studies and facilitates a team of reviewers to concurrently screen studies. In case conflicts arose on whether the study should be included or not, a third reviewer was involved in solving the conflict. When discrepancies in scores concerning quality and strength of the studies were detected through systematically organized comparison, a discussion was held to resolve these discrepancies and reach agreement on the quality and/or strength score.Of 7,698 records retrieved, 115 studies met the inclusion criteria see . In lineThe UNFPA–UNICEF Joint Programme on the Elimination of Female Genital Mutilation: Accelerating Change global theory of change and the compendium of indicators for measuring the effectiveness of FGM interventions were drawn on to classify the various intervention approaches , 26. BotThe strength of the evidence was assessed for all interventions included in moderate and high-quality studies. Combining the Gray rating of the moderate and high-quality studies with the geographical spread of the interventions allowed for analysis of successful programming towards abandoning FGM. Using the criteria described above for interventions that are successful, promising, and not working, System level interventions include those implemented at a macro level to provide an enabling environment for ending FGM. The system-level studies included in this review focused on assessing the effectiveness of national anti-FGM legislation in ending the practice.Legislation can provide platforms and avenues upon which other interventions can be safely implemented. Legislation may also serve to accelerate change in FGM practice in environments where community members are already questioning or have abandoned the practice and are seeking social acceptance. Nevertheless, evidence suggests that legislation alone is not effective in changing attitudes towards FGM and its prevalence –32. PrevLegislation enacted without consideration of the local context may be counterproductive and even harmful for intended beneficiaries , 46, as Service-level interventions aim to protect girls and women at risk of FGM, prevent FGM, and provide care to women and girls who have undergone FGM. Interventions assessed for effectiveness in this review include training health-care providers and capacity-building of the health system, and the use of rescue centres.Most of the interventions focused on imparting knowledge and skills to health-care providers, either to act as agents of change in the prevention of FGM or to offer better services to clients seeking health services post-FGM. Evidence shows that training can be effective in imparting knowledge to health-care workers , 57; enhRescue centres or safe houses aim to provide protection and refuge for girls who are at risk of FGM during the cutting period. Notably, most of the studies included rescue centres among other interventions, with limited information on the assessment of rescue centres as an independent intervention. Apart from providing shelter to girls running away from FGM, rescue centres also educate girls on the health risks and illegality of FGM, and its violation of human rights , 62. ResThis category included interventions implemented in communities with the aim of challenging existing gender inequalities and social norms associated with FGM. Specific interventions assessed for effectiveness at the community level were health education, comprehensive community engagement, media/social marketing campaigns/communication initiatives, public declarations/statements, working with religious/cultural leaders, and conversion of traditional practitioners.Health education interventions were mostly educational campaigns for awareness creation targeted at community members. Health education using the health risk approach can be useful in imparting knowledge related to the physical, psychological, and emotional consequences of FGM , 64. HeaA systematic review of educational sessions showed that the effects of health education across communities and target groups may not be uniform . PreviouCommunity engagement approaches create a platform for internal community discussions on harmful traditional practices such as FGM. Most of the studies focused on community dialogues or conversations where participants were expected to begin to question the role of some practices that are proven to have negative consequences, and therefore facilitate change. A systematic review of interventions to end FGM found that an underlying change mechanism was that providing information about FGM to communities, including men, would increase knowledge and change attitudes , 74–78. Community engagement approaches that use a holistic approach and seek to empower community members have been effective in changing attitudes towards FGM and in some cases changing behaviour , 79. It Research has shown that social marketing and media efforts are effective in changing social norms and attitudes towards abandoning FGM and in some cases, reducing the practice , 85–94. However, evidence shows that interventions which only supply information, education and campaigns to increase FGM awareness are not sufficient to change behaviour 15], and even might lead to medicalization of the practice . FGM is As FGM is often associated with religious and cultural obligations, changing religion and culture to support abandonment of FGM is therefore a viable approach to contributing towards elimination of FGM . ReligioPublic declarations of FGM abandonment by community, religious and political leaders or other influential people in a community are critical, as they may signal a commitment and readiness to abandon the practice , 99, 101Intervention activities involved either working with former traditional practitioners who had abandoned performing FGM or providing an alternative income to active traditional practitioners to encourage them to stop carrying out FGM. Evidence shows that there have been efforts to convert and provide traditional practitioners with alternative sources of income, but such efforts have been largely ineffective , 50, 102Interventions at the individual level include those that aim to empower girls and women to make their own informed decisions regarding their sexual and reproductive rights. Interventions assessed for effectiveness under this category were formal education for women in terms of educational attainment, and approaches that used alternative rites of passage to encourage abandonment.Evidence shows that formal education is effective in reducing FGM prevalence , 104. FoAlternative rites of passage allow girls to undergo training and to graduate to womanhood without being subjected to FGM . During Alternative rites of passage facilitate community ownership and support, as they maintain key cultural practices, increase knowledge and empowerment of girls, and increase publicity about change through community celebrations . HoweverThe review on which this paper is based has analysed the quality and strength of evidence for interventions to contribute to reaching SDG target 5.3 of zero new cases of FGM by 2030 . Most ofWhile the holistic and multisectoral approach is based on existing evidence on the pathways towards change, it is acknowledged that behaviour change processes are not linear; pathways of change are sometimes interdependent or cross-cutting –119. SynWhilst the strength of this review is evident, several limitations must be noted. First, this review is limited in its ability to reach a strong conclusion on the extent to which the assessed interventions led to a reduction in FGM prevalence, as most of the outcomes are related to knowledge and attitudinal changes. Moreover, causality was not ascertained as part of this review, as most of the interventions assessed did not use rigorous study designs for determining effects of interventions on intended outcomes. Second, most of the interventions reviewed had a short implementation span which may have been insufficient to observe changes in the practice. Equally importantly, this review only assessed evidence from existing evaluations, yet there may be many promising programmes being implemented that have not been evaluated and require further research. Third, measuring social change range from the description of how change occurs during and after implementation of the various interventions, to the measurement of changes in FGM practice or attitudes. This is challenging as it requires standardized indicators that can be compared over time and across settings. Fourth, the narrative synthesis approach combined with the Gray rating of the moderate and high-quality studies with the geographical spread of the interventions made it possible to analyse successful, promising and interventions with limited evidence on the effectiveness in ending FGM. Nonetheless, given the heterogeneity in study designs and the limited evidence across countries and regions overall, it is difficult to make strong claims about interventions that may be said to ‘work,’ particularly in varying cultural contexts.Overall, this review identified a general gap in monitoring, evaluation, and learning across the various interventions. Most of the monitoring and evaluation frameworks tended to focus more on process and intermediate outcomes, and less on demonstrating if interventions were effective in reducing FGM prevalence. This highlights the need for the application of robust study designs and analytical techniques that can clearly demonstrate the effectiveness (cause and effect) of FGM interventions on FGM abandonment, as well as the complementarity of each intervention in complex interventions.By assessing the quality and strength of evidence, this study has identified successful and promising interventions, as well as interventions with inadequate evidence on their effectiveness, and thus offers suggestions for guiding potential programming and policymaking. Firstly, health education, community dialogues with parents and religious leaders, the use of media and social marketing efforts, and formal education for women and girls are examples of interventions that have a strong enough body of evidence to justify wider implementation as part of comprehensive efforts to eliminate FGM. Secondly, legislation accompanied by political will in combination with additional interventions, creating FGM-free communities through public declarations, and training health provider are promising interventions with further evidence needed. Thirdly, providing traditional practitioners with alternative sources of income and alternative rites of passage with a focus on public ceremonial passage of girls is not effective in ending FGM. Lastly, adequately addressing FGM requires a holistic approach bringing together interventions that are sensitive to the complexity of FGM.S1 Checklist(DOCX)Click here for additional data file.S1 Text(PDF)Click here for additional data file.S1 Table(DOCX)Click here for additional data file.S2 Table(DOCX)Click here for additional data file.


Wandering spleen results from abnormal ligamentous laxity and is often symptomatic, presented with abdominal pain and other non‐specific symptoms. These symptoms, make the diagnosis very difficult and most of the times even impossible. As such, keeping in mind this pathology, can make further complications less frequent.  If the patient has not had a prior surgical splenectomy, some possible explanations include an ectopic or “wandering” spleen, heterotaxy syndromes, splenosis, or sickle cell infarction/autosplenectomy.Wandering spleen is a rare clinical entity with a less than 0.2% reporting incidence rate, which the spleen can be found in a number of positions in the abdomen or pelvis, and this condition is a result of congenital malformation or agenesis of the splenic ligaments or ligamentous laxity due to trauma, pregnancy, and connective tissue diseases.Given the high incidence of life‐threatening complications, in the case of splenic torsion and infarction in these patients it is very important to promptly recognize this condition and initiate appropriate treatment. In this article, we report a young woman presented with abdominal pain to a remote hospital in Iran.2A 25‐year‐old woman complaining of acute abdominal pain, presented to the hospital with an onset date of 4 days ago in the left quadrant that could not be tolerated. Her pain started in the epigastric area and then radiated to the LLQ (Left Lower Quadrant) and LUQ (Left Upper Quadrant). It was positional, exacerbated in the supine position, and got better in the sitting position, but it did not radiate to any other area. She stated that she had this pain since a couple of years ago, when she had the history of an IUFD  in the 29 weeks of pregnancy, but it had worsened a lot since 4 days ago. She also said that she could feel something moving in the exact region. She also complained of oligomenorrhea and headaches, which were followed by severe hypotension episodes and hospital visits. In her drug history, she only used h‐2 blockers. In her older documents, she had normal sonography. In the physical examination, she had tenderness in the LUQ and LLQ, and a vague giant lump was palpated in the LLQ, where the maximum tenderness was in that area, with no rebound tenderness or guarding.Laboratory data did not show any notable pathology, other than an abnormal complete blood cell, which indicated iron deficiency anemia, leukocytosis and thrombocytopenia.The abdominal X‐ray revealed an ileus without free air or air‐fluid levels in imaging modalities. An ultrasound revealed a low‐lying, 145 × 43 mm spleen that was absent from the left upper quadrant and the umbilical region of the abdomen. Torsion was not found. A CT scan was done to validate the findings. The diagnosis of a wandering spleen was confirmed by a CT scan, which also revealed splenomegaly and partial thrombosis in the splenic vein, as shown in Figure All of the aforementioned information led to the need for a splenectomy. Recovery after surgery went without incident. On the seventh day following the operation, she was released after receiving a polyvalent vaccination.3It seems that only <0.5% of splenectomies are due to ectopic positioning of the spleen, but because this condition is often asymptomatic and undetected, the exact incidence is unknown. However, a strong female predominance is described, with the average age of presentation of symptomatic patients ranging from 20 to 40 years of age.Wandering spleen cases may be asymptomatic unless splenic torsion takes place. However, there may be an increase in inflammatory markers or signs and symptoms of hypersplenism or functional asplenia. Laboratory testing are typically unspecific. Abdominal pain, leukocytosis, nausea, vomiting, and peritoneal irritation are common symptoms of splenic torsion in patients. In worst‐case circumstances, compression of surrounding organs may result in gastric outlet obstruction, obstructive uropathy, duodenal obstruction, and portal hypertension.Due to the unspecific clinical features of abdominal pain, imaging modalities and radiologist's awareness of this condition play a crucial role in diagnosing ectopic spleen. These include ultrasonography, nuclear scintigraphy, contrast‐enhanced computed tomography (CT) scanning, magnetic resonance imaging and angiogram.Surgical strategy changed over the time; splenectomy was the most reported treatment, but nowadays splenopexy is considered to be the optimal treatment for the non‐infarcted wandering spleen to avoid post‐splenectomy sepsis, however; many considerations have to be noted. A key consideration is the vascular status of spleen. Although imaging did not show us a problem, but during laparotomy evidence of ischemia and thrombosis was seen. Therefore, splenectomy was performed, but for a viable spleen, splenopexy is the treatment of choice.4Wandering spleen with torsion poses a great diagnostic challenge of acute abdomen in the emergency department due to the rarity of its occurrence. High index of suspicion, even in less probable patients is the key to early diagnosis and therefore splenectomy prevention. Due to this fact, splenopexy is considered to be the treatment of choice for these patients, if no other pathology is noted in the spleen.Shahab Ghasemi: Data curation; supervision; writing – review and editing. Dorsa Najari: Writing – original draft. mohammadmoein mirhosseini: Project administration. Meisam Refaei: Supervision; writing – review and editing.No funding sources.All authors have no conflict of interest to declare.Ethical approval was waived by the institution.Written informed consent was obtained from the patient to publish this report in accordance with the journal's patient consent policy.


Artificial intelligence and machine learning (AI/ML) are playing increasingly important roles, permeating the field of medical devices (MDs). This rapid progress has not yet been matched by the Health Technology Assessment (HTA) process, which still needs to define a common methodology for assessing AI/ML-based MDs. To collect existing evidence from the literature about the methods used to assess AI-based MDs, with a specific focus on those used for the management of heart failure (HF), the International Federation of Medical and Biological Engineering (IFMBE) conducted a scoping meta-review. This manuscript presents the results of this search, which covered the period from January 1974 to October 2022. After careful independent screening, 21 reviews, mainly conducted in North America and Europe, were retained and included. Among the findings were that deep learning is the most commonly utilised method and that electronic health records and registries are among the most prevalent sources of data for AI/ML algorithms. Out of the 21 included reviews, 19 focused on risk prediction and/or the early diagnosis of HF. Furthermore, 10 reviews provided evidence of the impact on the incidence/progression of HF, and 13 on the length of stay. From an HTA perspective, the main areas requiring improvement are the quality assessment of studies on AI/ML (included in 11 out of 21 reviews) and their data sources, as well as the definition of the criteria used to assess the selection of the most appropriate AI/ML algorithm. Heart failure (HF) is a multi-faceted and life-threatening syndrome and is one of the leading causes of mortality and hospitalisation. According to statistics, 64.3 million people suffered from HF globally in 2017 ,6,7.The widespread use of AI/ML solutions is expected to drastically change the domain of medicine and healthcare systems, especially after the World Health Organisation (WHO) included AI/ML-based medical devices (MDs) in the definition of “Health technology” ,9. As thSome barriers to the implementation of accurate AI/ML MDs for HF are already known. For instance, it is often difficult to identify a population with high enough event rates to demonstrate the effects of the solution . Such a For health technologies, this process is normally overseen by Health Technology Assessment (HTA)  principlThe other aim of this manuscript is to explore and systematise all the methods available in the literature that have been exploited by healthcare professionals to assess the quality of AI-based MDs, specifically those related to heart failure (HF).Box 1AI/ML-based medical devices (MDs) Medical device software that includes AI/ML algorithms. Artificial Intelligence (AI)AI is broadly defined as the science and engineering of making intelligent machines, especially intelligent computer programs . Health technologyHealth technology is an intervention developed to prevent, diagnose, or treat medical conditions; promote health; provide rehabilitation; and organise healthcare delivery. The intervention can be a test, device, medicine, vaccine, procedure, program, or system . Health Technology Assessment (HTA)HTA is a multidisciplinary process that uses explicit methods to determine the value of a specific health technology at different points in its lifecycle. The purpose is to inform decision making to promote an equitable, efficient, and high-quality health system . Heart failure (HF)A clinical syndrome with symptoms and/or signs caused by a structural and/or functional cardiac abnormality, corroborated by elevated natriuretic peptide levels and/or objective evidence of pulmonary or systemic congestion . The def HTA frameworkA methodological framework for the production and sharing of HTA information based on a standardised set of HTA questions (the ontology) that allows users to define their specific research questions within a hierarchical structure. (Definition adapted from EUnetHTA Core Model® ). Machine learning (ML)ML, a branch of artificial intelligence (AI) and computer science, focuses on developing systems that can learn and adapt without following explicit instructions, imitating the way humans learn. It gradually improves its accuracy by using algorithms and statistical models to analyse and draw inferences from patterns in data . Medical device software (MDSW)Medical device software is software that is intended to be used alone or in combination for a purpose specified in the definition of a “medical device” in the medical devices regulation (Article 2(1) of Regulation (EU) 2017/745—MDR) or in vitro diagnostic medical devices regulation (Article 2(2) of Regulation (EU) 2017/746) .The International Federation of Medical and Biological Engineering (IFMBE) created a multidisciplinary working group to discuss potential methods for assessing AI/ML-based medical devices. The group was composed of 15 expert professionals in biomedical engineering, human factors, health economics, and the HTA (with more than two years of expertise). A series of focus groups were organised to establish the research question and the inclusion and exclusion criteria, as well as come to an agreement on various definitions, as reported in The defined research question is as follows: “What are the methods used and evidence collected to assess AI/ML-based medical devices for heart failure and what are their strengths and limitations?”A meta-review  of systeEmbase and Scopus were searched for relevant literature. In addition, grey literature published on major HTA agencies’ websites was included. The literature search covered the period from January 1974 to October 2022. The detailed search string is reported in Appendixes The PICO  elements used in our review were as follows: Population—patients affected by HF; Intervention—AI/ML-based MDs; Comparator—traditional methods used in clinical practice and conventional statistical methods; Outcomes—accuracy, effectiveness, and organisational outcomes such as admissions/readmissions and/or impact on the length of stay (LOS).The inclusion and exclusion criteria were based on the publication type and topic. Only studies reporting on AI/ML methods applied to the prediction of HF risk, monitoring, and management of the disease were included. No limitation was considered for the setting of their use . In addition, only systematic or scoping reviews or meta-analyses were considered for inclusion. All the other publication types, as well as all those out of our scope, were excluded.The titles and abstracts of the retrieved articles and their full texts were screened by two researchers independently. Any conflict between the reviewers was resolved by the involvement of a third independent reviewer.For the data extraction, an ad hoc table was created to collect data on both the review and the AI/ML methodology, including data sources (literature database), quality assessment, comparison of results, and clinical and organisational endpoints.The included studies were categorised as (i) ‘meta analysis’, (ii) ‘systematic review’, or (iii) ‘narrative review’.To manage the data/evidence traceability, from each of the selected studies, we extracted information regarding the specific literature search engines and the countries of the items included in the review.The AI/ML algorithms were categorised using the framework adopted by Graili et al.  and propMany guidelines have been proposed for reporting trials that evaluate AI-driven technologies , Pubmed (n = 8), Cochrane Library (n = 6), Embase (n = 5), and Web of Science (n = 5). In terms of geographical representation , the selThe majority of reviews (16 out of 21) aimed to provide an overview of methods and AI/ML models developed for HF ,49,50,51We adopted quite a vast definition of HF . The classification of HF was considered in only seven cases, and the prognosis was included in only five cases. In terms of the clinical setting making use of AI/ML algorithms, in half of the cases, both the inpatients and outpatients were considered. Ten studies did not report this information.The datasets used as the base of AI/ML algorithms were different . Among tTo investigate the AI algorithm used category, the same framework reported in  was adopFinally, in terms of the quality assessment of the studies included in the selected reviews, in 11 cases  paying great attention to the impact on mortality. The impact on the incidence of progression of HF was assessed in 10 reviews, whereas the impact on admission/readmissions or LOS was reported in 13 cases. In four publications, it was unclear how efficacy or effectiveness had been investigated.Finally, the HTA requires a comparative assessment. EUnetHTA specifies that the comparator should be the alternative intervention(s) against which the intervention under assessment should be compared. As shown in The main finding of our scoping review is that when it comes to AI/ML models for HF for different purposes , there is a heterogeneous set of approaches adopted by developers in terms of not only algorithm design but also evidence generated and reported on the characteristics and performance of these algorithms. Such heterogeneity became clear when considering the aims of the selected studies, as well as the methods and data sources of the AI/ML algorithms, and identifying the comparators.Our analysis mainly focused on the current types of evidence available in the assessment of AI/ML-based MDs.We did not discuss the details of the accuracy of AI/ML algorithms or the likelihood of transition of AI/ML algorithms into clinical practice. In the same way, we did not investigate the factors affecting the choice of quality assessment scales. Various quality assessment scales are available for appraising the quality of clinical research related to AI/ML technologies, but there seems to be no unified standard for choosing those scales.Generalisability and representativeness. The majority of the retrieved systematic reviews mainly considered cases in developed countries , with anQuality of available evidence. Guidelines for reporting trials that evaluate interventions are increasingly used when it comes to modelling the impact of AI-driven technologies. For instance, TRIPOD-AI  was deveAI/ML methods. Different models are currently being developed to manage HF, but no guidelines are available for assessors to investigate in detail the reliability of each algorithm and capture the added value of one AI/ML model in comparison to others. Given the long list of methods currently used, as shown in Comparative evidence. Only a small proportion of studies evaluated AI/ML algorithms without conducting any kind of comparison. This is a promising result . HoweverData sources. Last but not least, the data at the core of AI/ML algorithms are crucial. They are usually real-world data/evidence (RWD/RWE), which are becoming more and more relevant for the HTA and decision makers. While investigating the complexity of AI for the HTA, Alami et al.  mentioneThe HTA is based on the available evidence for assessing a health technology in comparison with current clinical practice . ConsideThis study systematically analysed and synthesised data from multiple studies, providing a more robust and reliable analysis compared to a single study. We investigated whether AI/ML research and development is relevant to the HTA. In a way, our analysis integrates the analysis carried out by Sharma et al. , which dHowever, due to the relatively new nature of AI-based MDs for HF, the data available for review are limited. This limitation affects the completeness of the analysis and the conclusions drawn from the study. The quality of the data extracted from the articles included may vary. The inclusion of low-quality studies may affect the overall conclusions drawn from the review, as comprehensive control criteria were not established. In addition, the methods used to evaluate artificial intelligence-based medical devices for heart failure may vary depending on the device, data, and intended use. Therefore, our study does not cover all areas of the HTA. Ethical and legal aspects are completely outside our scope. Finally, to ensure that the selection process is as objective as possible, the lack of standardisation of the methods and reporting needs to be better investigated.This scoping review allowed us to identify the challenges posed by AI/ML-based MDs for a specific clinical condition (HF) and from the perspective of the HTA. The situation is rapidly evolving, as demonstrated by the significant increase in the number of studies on AI/ML algorithms and their implementation in clinical practice . TherefoIn our scoping meta-review of the methods used to assess artificial intelligence (AI)-based medical devices (MDs) for heart failure (HF), we uncovered critical insights into the dynamic landscape of AI applications in healthcare. Our analysis emphasised the heterogeneity in the approaches taken by developers, highlighting the diversity in AI/ML models designed for various HF management purposes. This diversity extends beyond algorithms to encompass evidence generation and reporting, signifying the evolving nature of this field.We identified key challenges that warrant attention in the evaluation of AI-based MDs for HF. Notably, the limited generalisability of the evidence due to a predominant focus on developed countries poses a barrier to making recommendations applicable to diverse healthcare settings. Additionally, the absence of standardised quality assessment practices for AI/ML in clinical research raises concerns about result interpretation. It is crucial to develop and agree on reporting standards and assessment tools tailored to the unique features of AI/ML technologies.The proliferation of AI/ML methods presents both promise and complexity. The absence of guidelines for assessing reliability and value in these methods complicates comparative assessments, hindering the ability to select the appropriate comparators and conduct thorough evaluations. Moreover, our findings reveal a shift in comparison practices, with AI/ML algorithms often benchmarked against each other or other statistical methods rather than current clinical practice. This departure from standard health technology assessment (HTA) practices underscores the need for comprehensive comparative evidence.Real-world data/evidence (RWD/RWE) emerged as a vital consideration, with its use becoming increasingly relevant to the HTA and decision makers. However, the challenges associated with RWD/RWE, such as data quality, representativeness, and fragmentation, amplify the complexity of AI/ML evaluation. Addressing these challenges will be pivotal for harnessing the potential of AI in HF management.In conclusion, our meta-review bridges the gap between AI/ML research and clinical practice, offering a comprehensive overview of AI-based MDs for HF evaluation methods. Although our study has strengths, including systematic analysis and an emphasis on the HTA’s intermediate role, it also has limitations due to the evolving nature of AI applications and the variability in the data and methods used.Looking forward, we recommend revisiting this analysis in three to five years to check the progress and the emerging challenges. Future research should delve deeper into aspects like data quality, representativeness, and the criteria used to select the appropriate comparators.In summary, AI-based MDs hold promise for enhancing HF management, but assessing them poses multi-faceted challenges. Our meta-review underscores the need for standardised evaluation practices, greater attention to data quality, and the pursuit of comprehensive comparative evidence. As AI/ML technologies continue to evolve, so too must our evaluation methods to ensure their safe and effective integration into clinical practice.


Within the predator–prey relationship, predator behavior is less studied. Even in natural populations, it shows great diversity, and the factors influencing this are even less known. Among these factors, the personality type of the individual,  and the practice significantly influence the success of adapting to a changing environment and switching to new prey types. In the present study, we investigated the first five consecutive foraging trials on live fish prey in naïve pikeperch individuals, which previously consumed or refused pelleted food. We hypothesized that individuals which were willing to consume alternative (pelleted) food would also show higher foraging success on living prey and that the practice would influence the learning process. Our results show that the timing of prey detection is influenced by exploratory behavior, the latency of the first attack by the aptitude for consuming pellets, and both traits by the individual's practice. However, neither of the factor affects the latency and success rate of capturing the prey, suggesting that predation is an independent behavioral trait.The online version contains supplementary material available at 10.1007/s10071-023-01747-4. The environment shows changes by anthropogenic influences which have a strong effect on the behavior of individuals, causing an adaptation in which cognition has a significant role  affect it   often results in the advantage and fast growth rates of aggressive and explorative individuals, under hatchery conditions  hypothesis originally explained population or species differences in suites of life history and physiological traits, extending the concept of a fast–slow life history continuum  and the method of prey capture. Our primary question was whether individuals that are faster at learning to eat pellets also perform faster on live prey and, if so, which elements of prey acquisition are affected. Our secondary objective was to see whether, as in the previous study, pellet-consuming individuals would be less exploratory and whether exploration would affect live prey capture independently of pellet consumption. Our third objective was to determine the number of trials required to reach a threshold during learning, after which prey capture latency is no longer significantly reduced.All procedures performed in this study followed the European Directive 2010/63 UE. The protocol was in accordance with the ethical standards of the Hungarian University of Agriculture and Life Sciences Kaposvár Campus and approved by the Committee on the Ethics of Animal Experiments of the Hungarian University of Agriculture and Life Sciences Kaposvár Campus (permit number: 3/2016-MÁB). The authors confirm that all experiments were performed in accordance with relevant guidelines and regulations.−1, and the temperature was kept at 21 ± 0.5 °C. The lighting provided 50 lx with a cycle of 12/12 h. The water quality parameters were determined twice a week using a Compact Photometer PF-12 Plus (Macherey–Nagel). The measured parameters were as followings: dissolved oxygen = 7.8 ± 0.4 mg L−1, pH = 8.0 ± 0.1, ammonia (NH4+) = 0.3 ± 0.2 mg L−1, and nitrite (NO2−) = 0.15 ± 0.03 mg L−1.The rearing unit, previously used by Molnár et al. Sander lucioperca L.)  were purchased from the BO-FA Fish Farm . The habituation process was very similar to the protocol published by several authors . The aquaria worked in a recirculation system with a total volume of 3000 L and were equipped with a UV filter. The size of the pellets was 1.1 mm  during habituation and changed during the following rearing period (10 weeks) between 1.5 and 4 mm: Nutra Pro MP-L, 1.5 mm , Alterna 1P, 2.5 mm  and Alterna 2P, 4 mm . The fish consumed the pelleted food, Skretting Alterna 2P, before the start of the live prey foraging tests, while fish refusing to consume the pellet continued to consume Continuous detection and removal of cannibalistic individuals were performed during the experiment. Cannibals were easily detectable in the morning before feeding on their full stomach , and these individuals were removed and reared in a separate tank. Cannibals were excluded from the behavior test.From the total of 36 fingerlings with an average standard body length of 90.0 ± 3.2 mm, two sub-groups were formed: 18 that consumed pellets  and 18 that did not (pellet non-feeder (PNF); 90.0 ± 3.6 mm).The survivors of the experiment were used in further experiments after the study, as the natural behavior of the animals was studied. We did not use euthanasia.A novel object test was performed according to Molnár et al. . The fis12 h preceding the tests, the fish were transferred individually into the test aquarium. For every single individual, five consecutive hunting tests were conducted, and 12 h breaks were applied between the tests to maintain motivation (hunger). Animals from the two groups were tested in parallel in a random order, the test aquariums were randomly used for the groups.Pethia conchonius) fish as prey with a standard length of 20 mm. The Rosy Barbs were bred for this purpose, and in each session, new (naive) individuals were used. The test started with the removal of the separating plate and ended with a successful hunting attempt or terminated after 60 min. The behavior of the tested pikeperch was recorded with a Sony HDR-XR camera. During the experiment, a total of 180 records from 36 fish were analyzed. The video recordings were analyzed manually with the video trimming function of the PMB version 5.2 software. The same person detected the behavioral events for all fish, and the video ID did not contain any information about the treatment groups. While evaluating the video, the following variables were recorded: the time points (TP) of 1. The detection of the prey (sec), 2. The first attack (sec), 3. Successful predation (sec), and, in the case of successful hunting, the type of catch . Detection of the prey was recorded when the pikeperch turned in the direction of the prey, the first attack was recorded when the fish first began to swim toward the prey, and successful predation was recorded when the prey was captured .Three sides of the test aquarium (90 × 35x35 cm) were painted black. The aquarium contained small-sized, dark, granulated gravel and an artificial plant. It was divided by a non-translucent plate. The tested pikeperch was placed into the larger part (70 cm), while the smaller part contained three premature (not colored) Rosy Barb , the latency of the first attack (Lfa = TP first attack- TP starting the experiment), and the latency of predation (Lpred = TP hunting- TP starting the experiment).U test performed on the data of the 36 individuals. The correlation between the predation success and the latency of the first attack and the latency of the predation was calculated by Spearman correlation. The effects of exploratory parameters , feeding aptitude (willingness to eat pellets), and the practice  were analyzed using a Cox Proportional Hazard regression model performed on the latency of the detection, first attack and predation measured in the total of 180 life foraging tests. Statistical analyses were performed using SPSS 17.0 software  even though neither the latency  nor the distance  of the closest approach was significantly different between the two groups (pellet non-feeder (NPF) and pellet feeder (PF)), yet the pellet non-feeder fish was slightly faster to explore the new object .The raw data of the experiment are presented in Table S1. 21 successful predators were detected, 11 of which belonged to the pellet non-feeder (PNF) group and 10 to the pellet feeder (PF) group. The 21 individuals consumed a sum of 47 prey items. No significant difference was found between the numbers of successful predations in PNF and PF  and the latency of the predation .The predation success showed a correlation with the latency of the first attack  preyed only once, 3 (2 in PF and 1 in PNF) twice, 4 (4 in PNF) three times, 1 (1 in PNF) four times, and 3 (2 in PF and 1 in PNF) individuals preyed five times.P = 0.055), resulting in a lower latency in the PNF group compared to the PF group (Exp(B) = 0.727, Table For the latency of prey detection, we found a significant effect of the two parameters of the novel object test measuring exploratory behavior, the minimum distance (Dmin) and the latency to achieving it (Tmin), but their hazard ratio moves around one, indicating only a small effect Table . BesidesP = 0.053) significance level, but not the minimum distance and its latency. In addition, the parameter was significantly affected by the aptitude to consume pellets (P = 0.005) and, similarly to the latency of detection, the foraging practice (P < 0.001) .In the case of the PNF group, the latency was found to be lower compared to the PF group . However, the latency value in the fifth trial was lower (1016.9 ± 1308.4 s) it did not differ significantly from the latency measured in the fourth trial (Table P = 0.385)  Table .Table 4C2 = 5.804, P = 0.669; Table 2 = 5.922, P = 0.052) caused by a complete absence of grabbing the body in the PNF group . The distribution of the methods used in the five attacks did not differ , 17.6% (35/199), and in pike Esox lucius (TL 182–221 mm), 15.1% (25/166); and in pikeperch (TL 192–228 mm), 8.5% (18/211) of the attacks ended with predation. Under natural conditions, the stomach content provides information on the previous 35–83 h of prey acquisition, depending on the temperature (Molnár and Tölg Our primary hypothesis was not confirmed as willingness for pellet consumption did not affect the predation success of the pikeperch in the tests which was 22% (20/90) in the PF and 30% (27/90) in the PNF group. In rainbow trout and brown trout, no differences were found in the predation success of hatchery stocks (18% and 16%); however, the prey consumption of wild fish was significantly higher in both species (82 and 81%)  faster than the tank-reared conspecifics.According to the novel object test, the frequency and speed of exploration were higher in the PNF group than in the PF group. Although both pellet consumption willingness and exploration influenced foraging behavior, their effects were different. Exploration (distance and latency) played a role in prey detection, with lower detection latencies in more exploratory individuals. However, pellet consumption willingness had only marginal effect on this parameter resulting in a lower latency in the PNF group. Fast exploring individuals should encounter new stimuli more quickly, may appear to be faster on learning challenges because of lower detection latency  were influenced by exploratory behavior and aptitude to pellet feeding, none affected the latency of successful predation. Szopa-Comley et al.  suggesteVimba vimba) on the adaptation of the pikeperch to the intensive culture. However, Horváth et al. (Perca fluviatilis), while weaker habituation was observed in the case of the conspecific teaching individuals. In perch, the presence of conspecifics also significantly influenced the prey selection and, within this, the rate of cannibalism (thus predation hazard) as a function of the social behavior and activity of the predators Below is the link to the electronic supplementary material.


The fundamentals of digital transformation include the conversion of the traditional method into a digital format to develop a standardized system that collects, analyzes, and processes quantitative data. This study aims to provide a comprehensive understanding of the development process and key elements of evidence-based digital integrative arts therapy.The “Digital Mandala” service in the “Mental Health App” produced as part of a national public mental health project for personalized depression management is adopted to explain how to convert the existing mandala art therapy into digital format. A living lab approach has been applied, which can be used to address the nation's mental health challenges by promoting collaboration, innovation, and evidence-based solutions.Evidence-based digital content requires evidence that covers the structural process, the effects of existing methods, and the components and meanings of each detailed scene. In this section, we provide five stages of the development process, including preliminary research, design, development, commercialization, and advancement. Consequently, clinical elements, integrative arts therapy features, and data factors are defined as the key principles of evidence-based digital integrative arts therapy.Based on the data factors found in this study, it will be possible to create an evaluation dataset of digital integrative arts therapy content for managing depression. Additionally, the large-scale public data can be analyzed through artificial intelligence technology, which is expected to be used as a basis for deriving significant results in a new form, going further than the existing evaluation method. This research is significant because it establishes the foundation for digital transformation in the field of art therapy for public mental health services and investigates its potential. Innovation in the medical field is accelerating since the frontier technology that forms the foundation for the Fourth Industrial Revolution  has begun to be applied to the healthcare arena . The newThe Digital Wellness Service (DWS), which introduced after the development of ICT, encompasses digital technologies or content for our body and mind to promote a healthy and balanced life . It provThe development of DWS requires a systematic approach and not just the use of digital media. A new strategy is required to innovate based on digital technology that utilizes ICT, such as big data, artificial intelligence (AI), and cloud computing. The core of digital transformation is the conversion of the traditional operation method into a digital format to digitalize and establish a standardized system that collects, analyzes, and processes quantitative data. Digital transformation refers to quantifying unquantified areas. It can facilitate quantitative evaluation in arts therapy, which was previously qualitative in nature. Digital conversion through data factor derivation can provide quantitative analyses in qualitative fields. It meets the needs of digital individuals and can be very useful for mental health.This study aims to identify evidence-based digital transformation methods by presenting a practical development protocol for the “Digital Mandala” service in the “Mental Health App” produced as part of a national public mental health project for personalized depression management. Living lab approaches have been applied to the development of digital integrative arts therapy. This article provides an in-depth description that details how traditional mandala art therapy was transformed into a digital form (RQ1). Additionally, it clarifies the core components of evidence-based digital integrative arts therapy by presenting the evidence supporting the elements of each scene and why the content was organized this way during the digital transformation process (RQ2). Ultimately, this study emphasizes the importance of seizing the opportunities that the digital world offers in the future and focuses on mental health.The Seoul Metropolitan Government has introduced a pilot program for the “Mental Health App” service, which is being tested by 500 young individuals participating in the “Youth Mental Health Management” support project , 17. TheThe Mental Health App provides user-customized digital content to diagnose mental health and prompt recovery from depression , 19. As This study focuses specifically on providing a detailed description of a practical development protocol for evidence-based digital content. In this regard, as a research tool, we selected the Digital Mandala service to examine the digital transformation method and explore the evidence-based elements of digital integrative arts therapy. This study provides comprehensive and thorough information and explanations about the digital transformation method and content development process of mandala art therapy (RQ1) and the core elements of evidence-based digital integrative arts therapy (RQ2). In this project, we have implemented the Digital Mandala service, which converted the traditional experiential mandala art therapy technique, known as structured mandala coloring, into a digital format. The digital transformation process and content development protocol involved the following procedures: First, an analysis of the session operating structure of traditional mandala art therapy was conducted. Second, the core elements necessary for the digital transformation of mandala art therapy were analyzed and presented. Third, evidence-based digital integrative arts therapy content was designed and implemented in digital form. Mandala is a magic circle with a center that provides a journey to find one's inner balance as a principle of mental structure. A compound word of “manda”, which means center and essence, and “la”, which means possession and achievement, “mandala” refers to possessing the essence in the shape of a circle. Analytic psychologist Carl Jung  began to use mandala as a therapeutic technique, which has since been expanded into mandala art therapy. Jung asserted that the act of drawing within the circle facilitates relaxation and the content of the mandala allows “expression of the self-healing process” .A structured mandala is an artistic activity in which a pre-designed mandala pattern is colored. Coloring a mandala is an appropriate art therapy activity to investigate its effectiveness because it involves the manipulation of art materials and individual decisions about color, shape, size, and patterning, and can produce a sense of accomplishment . AdditioDigital transformation requires structuring. It is necessary to examine the format for organizing and conducting clinical sessions to digitize the current methods of arts therapy. Choi  conceptuThe evidence-based digital content development process was conducted in an agile format. The Digital Mandala service was developed through preliminary research, design, development, commercialization, and advancement .In the preliminary research phase, market analysis and fundamental information were investigated, followed by a literature review to collect evidence for content development. Evidence-based digital content requires scientific, empirical, and theoretical basis from various perspectives. Therefore, three key factors of evidence-based digital content development were identified.First, medical advice from psychiatric clinicians and mental health specialists were used throughout this process to collect clinical evidence. Furthermore, the “Evidence-based Guideline for Depression in Primary Care” issued by the Korean Academy of Medical Sciences and the Korean Disease Control and Prevention was consulted. Second, the features of the arts therapy were examined. Theoretical data on stimulating factors such as the senses of vision, hearing, and touch and arts therapy techniques  were gathered. Finally, the device, gamification, and UI/UX, as well as the data assessment criteria, were determined. In contrast to digital therapeutics, the digital wellness service does not require strict clinical evidence to validate its therapeutic effect. However, it is essential to determine the empirical and theoretical evidence and secure its reliability and validity as a mental health service. In this study, a “digital transformation factor” was identified as the data factor for evaluation. In the design phase, it is necessary to define the type of data to be collected later by considering its therapeutic significance. Therefore, a data factor, a storyboard, and a screen design were proposed. It provided a visual presentation of the organization and development of the content. Moreover, it discussed the evaluation of use intention, possibility of continuous use, perceived usefulness, and satisfaction. Concerning the content, the Digital Mandala service was designed under four main themes . First, During the development phase, it is necessary to choose a content developer while also establishing an operating system to be used after content development. Furthermore, content usage management and software patent registration should be considered. At this stage, a content developer was selected and the core technologies related to digital content production were investigated. Actual content creation proceeded with the UI/UX design, choice of data collection strategies, and establishment of an operating system. Since digital content is created through flexible interactions, agile responses from practitioners are required during the development phase. Consequently, we continued to collect evidence for production and achieved content creation.In the commercialization phase, it is necessary to release the developed content, create a manual that introduces functions, and create content accounts. Furthermore, the assessment data defined in the preceding stage must be gathered in real-time and saved in the Cloud to build the framework for standard verification and improvement. As part of the Seoul Metropolitan Government's public mental health services, this pilot project was commercialized implementing the Digital Mandala service for depression management. The components and core evidence of the commercial content are presented in the results.In the advancement phase, it is important to supplement the contents by analyzing the acquired public data and user feedback. Standard verification and advancement work can be conducted by assessing the acquired log data and reviewing survey data on the use of the contents, which includes items such as the intention to use, continued use, and satisfaction as a public mental health service. Additionally, it requires supplementary work to function as high-quality content that may be utilized continuously, such as obtaining feedback on the UI/UX and progressing with upgrades. Throughout this process, digital content can establish a standardization system using quantitative data and secure scientific results, such as clinical efficacy and validation. The scope of this study is confined to the creation process and evidence-based element analysis; hence, it does not include the assessment of digital content usability or the evaluation of efficacy through pre- and post-inspection. Content advancement will become possible in the future using the digital transformation factors presented in this study.Since an increasing number of contemporary people have been reporting depressive feelings and lethargy following the COVID-19 pandemic, the new phrase “COVID Blues” has been coined. This phenomenon can be regarded as a collective depression that arose with the advent of a contactless era of social distancing. The Korean Ministry of Health and Welfare, in an attempt to provide necessary psychological support services for Korean citizens, has been conducting the “COVID-19 National Mental Health Survey” on a quarterly basis since 2020 to comprehend the state of their citizens' mental health. According to the statistics in the second quarter of 2022, even though the index of the depression risk group improved (22.8% in March 2021 to 16.9% in June 2022) after social distancing ended, the figure still represented a high and dangerous level that was over five times higher than that of 2019 (3.2%) before the COVID-19 outbreak . ConcurrMajor depressive disorder, commonly known as depression, is a mental health problem defined as a lethargic state accompanied by a chronically depressed mood or sad state and loss of interest or pleasure in life. It is classified as a very serious mental disease because it is associated with anxiety and sleep difficulties, deteriorates interpersonal competency and occupational ability, and can lead to suicide in extreme situations. The causes and risk factors for depression differ from individual to individual; they are most typically explained by the stress vulnerability model . In otheAlthough large-scale studies specifically examining mandala art therapy are lacking, some studies included in The Digital Mandala is an integrative arts therapy content that stimulates the senses of sight, hearing, and touch through a digital experience. This content, which combines art, music, and literary interventions, aims to increase therapeutic efficacy by balancing the states of closeness and separation. Owing to the characteristics of the mobile device, tactile stimulation felt by the hand and visual stimulation of images are continuously activated during the screen-touch interaction process. Furthermore, the Digital Mandala content is accompanied by auditory stimulation via emotional music. The human desire to select colors occurs in the brain. The brain stimulation through colors is expressed as emotion, which is a physical instinct. Each color has its own vibration and frequency that stimulates a response in the process of being transmitted to the brain and creates emotional expression. When a specific color is transmitted to the hypothalamus through visual perception, it passes through the A10 nerve and produces the judgment of good or bad. Therefore, choosing a color can be perceived as a measurement of not only one's desire for pleasure but also as a tool to detect internal changes . A studyIn art therapy using the structured mandala, such tendencies of clients can be analyzed according to the direction of their coloring. In the mandala artwork, introverts unconsciously tend to color from the center to the circumference of the circle, whereas extroverts or those who currently feel nervous, powerless, exhausted, have low concentration, and high distractibility tend to color the mandala from the circumference into the center . AdditioIn the Digital Mandala service, the mandala artwork process includes a structured mandala pattern selection, line drawing, and coloring, followed by a rotation in the appropriate direction . The strChromatic colors: red, yellow-red, yellow, red-purple, green-yellow, green-purple, pink, brown, blue-green, blue, and purple-blueAchromatic colors: white, gray, and black.Music has been used as a sensory tool to express people's mood and emotions. Dynamic experiences, such as rhythm and melody, provided in the process of integrative arts therapy stimulate individual emotions and expand conscious awareness . Thus faRobert Thayer , a music psychologist, defined a two-dimensional mood/atmosphere model by setting “Stress” and “Energy” categories. Here, “Stress” is the degree from “Happy” to “Anxious/Sad,” while “Energy” is the degree from “Calm” to “Energetic.” The mood model classifies the emotions of “Exuberant, Anxious/Frantic, Contentment, Depression” within the two axes of “Stress” and “Energy” . When acThe second stage is to choose a feeling and emotional music that represents the user's current condition . The purFeeling: happy, exuberance, energetic, contentment calm, loneliness, and sadEmotional music: music 1 (happy), music 2 (exuberance), music 3 (energetic), music 4 (contentment), music 5 , music 6 (loneliness), music 7 (sad), and music 8 (depression).The use of literary media allows the linguistic imagery of one's inner world to be expressed through symbols and metaphors. This has a therapeutic effect that encourages the reorganization of memories and psychological dissipation as a way to express thoughts and feelings . ReflectMaintaining a balance between the two states of separation and closeness is referred to as “distancing” . AccordiThe Digital Mandala service was digitalized from the existing practice of immersive mandala art therapy into a mobile app. It was developed as an evidence-based digital content, including three types of evidence . The session operation structure to digitize mandalas was elucidated using the theory of the arts therapy clinical system . The strThe traditional method and digitized content share the same objectives and activities because they both attempt to induce mindfulness through the mandala coloring technique, which aims to reduce depression and anxiety. However, the Digital Mandala is distinct in that its users can access it anywhere at any time and self-manage their depression due to the nature of mobile devices. Additionally, the digital content has its own unique evaluation methods. Traditional arts therapy mainly uses qualitative evaluation , which has been criticized on its lack of clinical effectiveness and limitations in effectiveness verification. Despite continuous attempts to examine the degree of change through pre-post assessments, they have not gained sufficient support for clinical effectiveness due to small sample sizes and biased results. The limitations of traditional evaluation methods can be overcome through digital transformation. Because digital content is easy to access, large-scale pre-post assessments can be performed to validate its effectiveness. Furthermore, the data factor of mandala art therapy can serve as a criterion for quantitative evaluation.The extraction of data factors is fundamental for digital transformation. Data factors serve important functions throughout the content development procedure. Digital mental healthcare content is based on clinical evidence and permits quantitative data analysis with therapeutic value. Therefore, the present study established a strategy to extract data factors of the evidence-based digital content and apply them as evaluation elements to remedy the limitations inherent in traditional evaluation methods. Regarding data extraction, the type of mandala, touch position, diversity and frequency of colors, touch data for filled spaces at the end of coloring, rotation direction, and amount of time can be collected in the mandala artwork phase. Additionally, it is possible to evaluate emotions based on depressive symptoms and the mood component of music, as well as to analyse language data obtained from the mandala-note stage. Future studies should evaluate data systematically to provide individualized services. The log data collected at each stage and survey data on usability should be analyzed to assess the service. This provides a standard for customizing and upgrading the content.This manuscript details the development of digital integrative arts therapy content for public mental health services and focuses on expanding opportunities for leveraging digital in the future of mental health care. The scope of this study is limited to providing a practical protocol that includes an evidence-based element for developing the “Digital Mandala” service. It is meaningful to describe in detail the process that shows how the conversion of structured mandala from traditional use to app was achieved, but it does not include the application results of the Digital Mandala services.Based on the data factors found in this study, it will be possible to create an evaluation data set of digital integrative arts therapy content for managing depression. The living lab and open innovation system can also be used more by analyzing large-scale public data. The public mental health data can be analyzed through artificial intelligence technology, which is expected to be used as a basis for deriving significant results in a new form, going further than the existing evaluation method. Future studies need to be conducted to verify its efficacy, effectiveness, and efficiency through large-scale data collection and analysis of correlations between depressive symptoms and arts therapy factors. Especially the arts factors, according to the degree of depression, should be analyzed and evaluated quantitatively.This study was conducted to lay the groundwork for digital transformation in the field of art therapy for the public mental health services and to explore its possibilities. A practicable protocol for the development of evidence-based digital integrative arts therapy was presented, which converted the traditional structured mandala coloring technique into a mobile app called “Digital Mandala”. The study findings have been summarized below.First, digital transformation requires structuring. Digital content for integrative arts therapy can be structured based on the “session operating structure” theory . The cliThe significance of this study is that it provides a development protocol for data-based customized services through the Digital Mandala, which digitally converts the existing experiential approach of art therapy into digital content. Additionally, it presents the possibility of verifying the effectiveness of art therapy in the future by deriving data factors and digitally implementing the mandala technique. The data collected through the Digital Mandala can be used to expand the range of traditional arts therapies that have lacked quantitative or scientific effectiveness verification in randomized controlled trials (RCTs). If it is evaluated quantitatively using data elements, it will not only function as digital wellness content but also as digital therapeutics. Through this study, it is expected that the specific utilization and spread of digital and arts convergence content as public mental health services will be achieved.The original contributions presented in the study are included in the article/supplementary material, further inquiries can be directed to the corresponding author.Ethical approval was not required for the studies involving humans because this study aims to present a practical protocol for the development of digital mental health services. The studies were conducted in accordance with the local legislation and institutional requirements. Written informed consent for participation was not required from the participants or the participants' legal guardians/next of kin in accordance with the national legislation and institutional requirements because this study does not present the applied results of digital services.HK participated in the digital healthcare expert. YC contributed to the integrative arts therapy expert, and they conducted convergence research. HK and YC conceptualized, designed, and implemented the study. YC contributed to the original draft's writing, literature review, and analysis of the results. HK contributed to the project administration, supervision, methodology, and validation. All authors have discussed and agreed to the published version of the manuscript.


Aquatic literacy (AL), emerging from the broader concept of physical literacy and translated to the aquatic environment, comes close to the concept of water competence. Water competence is described as a broad spectrum of competencies required to effectively help to prevent drowning by integrating the physical competencies with the cognitive and affective. Dudley (2019) explains the learning’ in aquatic environments from a physical literacy perspective, describing four dimensions: psychomotor, cognitive, affective, and social aspects. In aquatic literacy special attention is given to positive motivation to engage in aquatic recreation, considering the degree to which individuals have been privileged or restrained for different aquatic activities in a variety of contexts.The European project “Aquatic literacy for all Children” or ALFAC aims to improve the quality of aquatic education, in order to prepare them to take part in wide range of water sports while at the same time protect children from the dangers looking for balanced ‘challenges’.Developing children's aquatic skills, motivation, enjoyment, engagement, and confidence will be studied in seven European countries. The target group consists of elementary school children.An international database, enabling situating the level of children on the basis of reference values is a valuable tool for pedagogues, researchers and institutional actors whose aim is to improve swimming education systems.The objective of building a standardized set of tests and a common evaluation will allow to build the foundations of a transnational work that will have repercussions on the national plans of aquatic recreation in general and school swimming in particular. The three elements of the Personal Assets Framework are inspiring for the educational approach in aquatics: (a) personal engagement in activities, (b) quality social dynamics, and (c) appropriate settings.With ALFAC a pragmatic but evidence based international AL measurement tool will be created enabling to identify the most relevant areas of progress in aquatic education. It will offer educational resources proposing tasks, technical content, and educational support to help individual children and groups in their progress of AL.