Translational Insights for the Development of Electromagnetic Devices for Rehabilitation and Palliative Medicine: An Analytical Hierarchy Process Contribution

doi:10.21203/rs.3.rs-4682271/v1

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Translational Insights for the Development of Electromagnetic Devices for Rehabilitation and Palliative Medicine: An Analytical Hierarchy Process Contribution

https://doi.org/10.21203/rs.3.rs-4682271/v1

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In the face of ongoing scientific debates over biomedical electromagnetic devices like TENS, TMS, tDCS, and PEMF, this study leverages the Analytical Hierarchy Process (AHP) to establish a ranking system that aids in the selection process for clinical research purposes. By adopting a structured Work Package Methodology, our interdisciplinary team dissected the research into six distinct phases, ranging from management and supervision to the development of guiding principles and the application of AHP for device evaluation. This approach led to the identification of nine critical selection criteria, including the minimization of external electromagnetic influences, device multifunctionality, cost-effectiveness, and the ability to induce relaxation and well-being in users. Notably, our analysis revealed that a hypothetical 'NEW' device outperformed existing technologies, suggesting a significant opportunity for innovation in this space. The findings advocate for enhanced translational research to bridge the theoretical and practical applications of electromagnetic technology in medicine. We propose that future endeavors should focus on creating new electromagnetic devices that align with the identified criteria, thereby improving the accuracy and reliability of clinical research in the field of biomedical electromagnetics.

The human civilization has preferably used chemical products to treat diseases, based on the understanding that life itself is considered a purely biochemical process [1, 2]. However, this perspective, in addition to being associated with the frustration of refractoriness in various clinical conditions, does not exhaust all the therapeutic options historically available. Such practices, belonging to Complementary and Alternative Medicine (CAM), involve several different therapeutic modalities, with an increasing trend in the practice of health care in several places in the world [3].

Although CAM is clinically relevant, there are many questions and a lack of evidence about how and if its therapeutic actions actually occur. One of the possibilities to find such evidence is through Biophysics [4], which, when directed to the health area, is associated with the study of the biomedical application of magnetic fields (EMF), both for diagnoses and for adjunct therapeutic techniques [5]. To bridge the gap between traditional chemical therapies and the holistic approach of CAM, this study delves into the potential of EMF as a non-invasive, innovative therapeutic option, exploring its mechanistic foundations and clinical benefits.

In this sense, the modi operandi on the use EMF are promising in relation to clinical applicability and can reduce the cost of treatment, fulfilling the partial goals of health innovation. It has been shown that the application of EMF can benefit patients in a wide variety of diseases [6, 7], thus becoming an area of extreme interest for those who seek options for rehabilitation and palliative medicine in view of the refractoriness of clinical treatments based on biochemistry [8]. Despite the historical use of EMF in various therapeutic contexts, the scientific community continues to seek robust, empirical evidence to elucidate the precise mechanisms by which EMF influences biological processes and contributes to health outcomes. By situating EMF within the broader context of CAM, we aim to expand the therapeutic arsenal available to practitioners, offering alternatives that align with the principles of holistic health and patient-centered care.

Otherwise, there is a current difficulty in accumulating comparable data on the biomedical application of this technology as adjunct therapy that would support its inclusion in clinical protocols and allow the innovation added to this technology to be really applicable. In the view of Saliev et al. [9], this difficulty generates controversial scientific reports. This often stimulates active debates about the biological effects of EMF in the literature and in the media [5, 8]. The controversy surrounding the use of EMF in clinical practice often stems from a complex interplay of scientific skepticism, regulatory challenges, and varying results across empirical studies, underscoring the need for a comprehensive evaluation of its efficacy and safety.

Given this, the aim of this study is to organize a ranking to assist in the decision-making process on the clinical and research reliability of the existing medical devices, trying to rescue scientific parameters and seek to expand the biomedical applicability of technology in order to contribute to the reduction of this controversy around this theme. Other researchers have already tried to make improvements to design through comparisons on similar topics, as Hartwig et al. [10] contributions for the devices designers to be used in Functional Magnetic Resonance Imaging studies and for neuroscientists.

The initial alternatives considered those previously existing and the most used for the biomedical application of this technology. The most frequently used Bioelectromagnetic Medicine devices in the USA are: (i) TENS (Transcutaneous Electrical Nerve Stimulation) devices for pain control; (ii) PEMF for bone fractures [7], 2018) and other diseases [5, 8]; and (iii) tDCS (Transcranial Direct Current Stimulation) or (iv) TMS (Transcranial Magnetic Stimulation), used to treat mood disorders and insomnia [11–13]. The authors – trying to bring something measurable to companies or people – added, in an exploratory way, a fictitious NEW device, representing innovation, to assess, through a quantitative data, whether or not the search for innovations in this field should be stimulated. Introducing a hypothetical 'NEW' device serves as a methodological tool to simulate innovation within the field, enabling us to quantitatively assess the potential impact of novel EMF applications on enhancing clinical research and patient care. This study represents an interdisciplinary endeavor that bridges physics, biomedicine, and engineering, illustrating the vital role of cross-disciplinary collaboration in unraveling the complexities of EMF and its therapeutic potential. By systematically evaluating and ranking EMF-based medical devices, we not only aim to mitigate existing controversies but also to pave the way for standardized, evidence-based integration of EMF therapies into clinical protocols.

The objective of this study was not only aim to mitigate existing controversies but also to pave the way for standardized, evidence-based integration of EMF therapies into clinical protocols, trying to rank the “best equipment for electromagnetics in biomedical applications.” The criteria definition, in the case of this study, took into account a generic structure of guiding principles and criteria to improve the robustness and efficiency of research on electromagnetics in biomedical. Such a structure was obtained through the actions of WP2, WP3 and WP4. Our interdisciplinary approach, integrating insights from physics, medicine, and psychology, has enabled a comprehensive evaluation of EMF devices, underlining the importance of a multifaceted perspective in biomedical research.

3WP2 actions

Achieving the objective “to know theories involved in understanding therapeutic action” was a complex process due to the interdisciplinary association. It was not just a matter of understanding concepts from Physics and Electromagnetism that generated hypotheses of how therapeutic action occurred. The complexity of the interdisciplinary relationship between professionals in the areas of exact and health increased when knowledge from the theoretical basis of CAM [14] was added, such as the influence of the touch or the biofield of therapist to be associated with a therapeutic potential [15, 16].

This knowledge influence about an individual's biofield, from a more holistic perspective derived from the theory of CAM, increased the identification and understanding of possible research biases associated with the biomedical application of electromagnetism. Such knowledge allowed the valuation of the psychological aspects that can influence the result of a treatment that, in addition to including psychological health, value the placebo effect (which should be stimulated) and the nocebo effect (which should be discouraged) [17].

The difficulty of dialogue between these professionals, from the hard sciences and from health area, on a topic – for example, accepting or not the possibility of one person's biofield influencing another – highlights the aforementioned complexity of establishing an interdisciplinary interaction. This perspective was not valued by researchers in the field of Physics and Engineering who participated as voluntary consultants. Physicians, in turn, with specific training in the area of mental health, on the contrary, defended the importance of including such concepts in understanding the therapeutic action of electromagnetic fields.

Another conflicting topic in the recognition of new theories under an interdisciplinary analysis was the acceptance of theories considered innovative by health professionals and without scientific theoretical support by professionals in the field of exact science. An example is the Water Memory Theory [18], initially proposed by Benveniste, which is commonly accepted by homeopathic doctors [19]. For professionals in the exact area, this theory is not commonly accepted, as there is just an incipient and controversial theoretical support [20].

The analysis of the product in relation to its use has as main objective to detect negative and criticizable points during its use [21, 22]. This extensive analysis was carried out as provided in the methodology and it included three distinct moments of data collection, but interconnected with each other, during the period of carrying out this design experience, which are presented below:

a) Through the professional experience of researchers in Palliative Care using PEMF technology for alternative control of refractory symptoms of patients [23]. Such experience, both in the handling of equipment and in the biomedical application itself, enabled a direct collection of data from direct observation;

b) Through the identification of the modi operanti of this technology, including focusing on clinical studies produced by research centers of Brazilian hospitals [24-27].

Direct observation of an equipment that uses emitting EMF for diagnostic purposes, such as nuclear magnetic resonance, is already part of the routine of medical activities. The use of these equipments for therapeutic purposes requires more specific training and the direct clinical use of these devices involves the practice of each professional specifically.

As a result of the researchers' clinical practice, in order to contribute to direct observation and analysis in relation to the use, the operation of only one of the evaluated equipment is followed, the EMF multioscillator by radio frequency, the PERM-L produced by Resonant Light [28]. This is due to the fact that this equipment is more relevant to the focus of this study, since it allows for different clinical protocols and is based on the patent for the device emitting PEMF [29]. In direct observation it is noticeable that, when the patient is conditioned, by the influence on his positioning, as in an environment previously prepared for application, and with the information that the setting of chosen frequencies involves the specific control of a certain symptom, the applicator directly influences the user's feeling. The operation of the equipment was thoroughly analyzed in WP2.

It is worth mentioning PEMF use has been documented with relative success in coping with cancer [5,8]. This, in itself, justifies the reason for the interest in going deeper into the adjunct use of this technology. However, this possible impulse towards new research to better document this evidence is still far from being an effective conclusion, since this analysis of the product in relation to use does not serve as scientific validation for the use of such technology [30].

The final results of the analysis of the product in relation to the use are:

a) That the users' emotional state influenced the sensation produced by exposure to predefined frequencies;

b) That the users' emotional state improved due to a sense of increased daily well-being, autonomy, pain relief and the expectation of survival;

c) That in those moments where the users were prepared by the researcher to receive the electromagnetic fields, they seem to feel the effects more clearly than when they used the equipment freely and unassisted, showing the real influence of the researcher;

d) That in those moments where users were in an organized environment for the operationalization of the process, they also seemed to feel the effects more clearly than when they used the equipment freely and unassisted, showing the influence of the environment;

e) That the convenience in the environment associated with the use of technology, in places that offered greater comfort and well-being provided by the customization of the environment, facilitated the use of pre-defined frequencies.

To ensure the reliability of our findings, we meticulously combined direct observations with in-depth interviews, enriching our dataset with both quantitative and qualitative insights that reflect the multifunctionality and applicability of EMF devices.

WP2 – an overview

The current scenario of clinical research of electromagnetics in biomedical applications can be presented through a quick bibliographic survey carried out on one of the data sources on clinical research, specifically the website www.clinicaltrials.gov of US National Institutes of Health [31]. The descriptors used were "electromagnetic" and "fields" that generated 80 clinical researches as result. This selection determines as appropriate clinical research the ones associated with studies on EMF and produced in the aforementioned repository. Out of the total studies, 72 were considered clinical trials in humans to assess the biomedical application of EMFs (Table 1).

[Table 1]

In addition to the profile of these studies, it is possible to identify the heterogeneity of its sponsors (Table 2). It is possible to identify that the researchers' interest, whether they are the owner or not of the device's patent, can generate scientific bias in the interpretation of the results, since the scientific field is a place of competitive disputes, in which the main objective is the conquest of scientific authority [32]. Therefore, it is possible to affirm that the scientific field is able to originate several forms of interests. Considering that scientific practices, in addition to being concerned with the advancement of science, also focus on gaining scientific authority (prestige, recognition, success), commonly known as interest, it is possible to say that what drives scientific activities always has more than one type of intention, as well as the strategies used to guarantee the satisfaction of this interest. From this perspective, it is possible to detect that 48% of clinical research are sponsored by the interested party, and there may be scientific questions about the neutrality of its results.

[Table 2]

Other important topic to be highlighted is that not all of these studies have generated scientific publications as results. Some were recently started and several were considered inconclusive because they did not generate scientific publications, because they were interrupted or because they had unknown status (Table 3).

[Table 3]

It is possible to observe the heterogeneity of the studies and the complexity that exists at the moment when the results are compared. In this sense, in these studies, the number of different indications (focus of the study – condition or disease) for the use of electromagnetic technology, the great difference between clinical protocols (including in some studies being omitted) and the diversity of equipment emitting different EMF are not properly identified (Table 4).

[Table 4]

In view of the existing diversity of study focuses (condition or disease) of clinical research of electromagnetics in biomedical applications, it is also possible to highlight the great difference that exists between the patients to be studied. Thus, to select the patients who will be participating in the research, there will be a great divergence between the selection criteria for those who will undergo cancer treatments in relation to those who will undergo aesthetic treatment, for example. The baseline health of an individual can differ greatly in these different clinical conditions. In view of this, there is more difficulty in comparing these studies due to different divergences in clinical conditions and selection criteria, in addition to the variation between devices, protocols, methods, among other aspects.

Other striking topic is the great diversity among the devices found in clinical studies registered [31]. It is important to emphasize that these models do not exhaust the variety of existing devices, but illustrate it. Such conceptual variation in the design of these products aims to clarify the importance of analysis, through a tool, to assist in the decision process over which equipment to choose touse in research and/or clinical for a given application. In this perspective, the scientific controversy which involves the biomedical application of EMFdescribed is due to the complexity of clinical research in the area [9], often protected by patent rights, industrial secrets or by the variation of device models [33, 34]. In clinical studies, the choice of frequency and intensity of the magnetic field to be used tends to be personalized and not standardized [5]. In addition, the internal and external validity of studies can often be open to criticism [5, 34] because there are numerous confounding variables such as the variety of possible EMF sources – pulsating, generated by AC, generated by DC, static, magnetic fluids, etc. [5, 33, 34]. Environmental variables are other possible complicating biases, since everyday human exposure to electric and magnetic fields is significant [33, 35]. This context increases the difficulty of systematic reviews and replication of studies in this area. It is important to emphasize the need for efforts to adopt standardized research models with better quality in order to have a greater exchange of information on this area in the scientific community [36].

Further, one more aspect often ignored, but potentially relevant and capable of influencing clinical research of electromagnetics in biomedical applications is the reflection on the impact of emotional reactions on humans, generating the placebo and nocebo effects [37, 38]. It has been described that it is possible to have a number of individual variables in relation to the equilibrium point of a human body. Physical and mental vitality, age, physical conditioning and the presence of clinical disease seem to be able to alter an individual's sensitivity to being influenced by EMF [11 ,17].

WP3 actions – Final criteria

For the development of the guiding principles and criteria of this study, the parameters of physical and biological factors determining the bioelectromagnetic response were used. In order to clarify their definitions, Table 5 presents the association between the criteria found in the literature on the topic and the criteria adopted to expand the greater scientific methodological robustness.

[Table 5]

Currently, there are efforts in several areas of scientific research in the organization of pre-existing data and in the search for standards in data collection in order to generate a database of comparable information that would optimize future research, including reducing costs. One such example is the European Commission's project 777364 [39] and the European Quality in Preclinical Data (EQIPD), which aims to increase the quality of data collected in preclinical studies. The EQIPD's main objective is to establish a quality management system suitable for pre-clinical research and develop standardized processes to guarantee the quality of the data, leading to a reduction in the research bias. For this new trend, the ideal would be to have a device capable of having a multi-use profile, but keeping the basic settings the same in order to generate comparable data in both collection and analysis. This justifies the purpose of this study.

The criteria considered important to be compared in the available equipment were:

a) Criterion 1 (related to the researcher): avoid the influence of the researcher or his team's biocampus;

b) Criteria 2 and 3 (related to the environment): (2) avoid exposure to other sources of EMF from electrical equipment or motors; and (3) avoid the influence of natural geomagnetism;

c) Criterion 4 (related to the research participant): that the equipment stimulates the individual's relaxation and well-being. These findings underscore the significance of the patient's emotional state and treatment environment in the efficacy of EMF therapies, suggesting a paradigm shift towards more holistic and patient-centered clinical practices.

d) Criteria 5 to 8 (related to the device itself): (5) that the equipment can be multifunctional, allowing the researcher to choose the source of EMF of their preference and, if there is interest, compare it them together; (6) have broad clinical applicability; (7) allow the active mode and “sham” without the research participant being able to identify; (8) the presence of simultaneous use of water or aqueous colloidal solution; and (9) have the lowest possible cost.

By aligning our criteria with real-world clinical needs, our study paves the way for the development of more effective and user-friendly EMF devices, potentially revolutionizing the approach to non-invasive treatments. These results not only corroborate previous studies highlighting the therapeutic potential of EMF but also advance the conversation by identifying key factors that contribute to the variability in treatment outcomes."

WP4 Actions – Weight assigned to each selected criterion

The choice of criteria, as well as their assessments attributed to the fictitious NEW model, came from the consensus arising from the actions of WP2, WP3 and WP4, which included, among other actions, an integrative bibliographic review, empirical observations about products, brainstorming among experts, and research on opinion of users. So, credibility in exploring the weight attributed to each criterion and on the ranking of the decision-making process was increased, resulting in a more consistent and effective decision model. Despite the satisfactory result, it was observed that, among the existing models, the ranking result generated some coincident or close values, as some projects received the same evaluations coincidentally, demonstrating possible similar solutions in the resolution of those projects at the time of their elaboration.

In the development of WP4, the direct attribution technique was used to assign values to factors using the Saaty scale as if it were a 9-point Likert Scale for attribution. Thus, 9 values (from 1 up to 9) were defined in order to contemplate the justification of choice. Table 6 presents the weight attributed in an exploratory way for each criterion by the authors and their justifications according to the relevance based on the results obtained in this selection phase. Table 7 presents the evaluation for each criterion [40] in each device attributed by the authors. The NEW option is the score considered minimum for the ideal device in each of these criteria. It is important to note that the result of the devices already existing in several criteria is very low, showing how much they devalue the importance of such parameters. Besides, the application of the AHP in our study has not only facilitated a systematic comparison of EMF devices but also established a replicable framework for future evaluations, enhancing the objectivity of device selection for clinical trials.

[Table 6]

[Table 7]

WP5 actions – Comparison of matrices by each criterion

Figure 1 summarizes the proposal for the application of AHP for this study and Table 8 shows the comparison for each criterion according to the AHP.

[Figure 1]

[Table 8]

WP5 actions – Final decision matrix

The comparison matrix of the AHP indicates the representative percentage of each device according to the evaluation criteria. In order to define the classification of the devices, it requires a matrix that gathers the results of the comparisons and establishes a rank. Table 9 shows the results of the final decision matrix. The Final Decision value is presented in Table 10, whose decision vectors are organized in order of the most representative to the least representative for biomedical application of electromagnetism.

[Table9]

[Table 10]

It is possible to conclude that PEMF was the most used equipment today and the one that presented the best performance (2nd place), with 17.16%, followed by TMS (3rd place), with 15.78%, TENS (4th place), with 15.08% and TDCs (5th place), with 15.00%. It is evident that the current models basically obtained equivalent results. However, they are very far from the proposed fictitious model, with 36.99%. Thereforen the proposed fictitious model is considered ideal to increase the robustness of clinical research of electromagnetic in biomedical applications.

From the above, the main findings, results and contributions of this study are also highlighted:

Team up is essential for clinical research in bioelectromagnetism;

There are a number of methodological biases in the area of clinical research

on electromagnetism;

c) Identification of the theoretical gap between the biomedical application of electromagnetism and laboratory evidence;

d) Identification that the biomedical application of PEMF can be a therapy for coping with oncological disease, through the analysis of the product in relation to its use;

e) The professionals in the exact area apparently ignore the influence of the biofield of the patient and the researcher and their psychological aspects during clinical studies on the biomedical application of magnetic fields;

f) The use of PEMF emitting devices ignores the contamination of the environment, the influence of the biofield of the patient and the researcher;

g) The importance of enhancing the environment with electromagnetic restriction and integration as a singular element of scientific credibility and therapeutic enhancement;

h) The realization of a new project experience is justified with the concrete possibility of creating a device capable of being a reliable and multifunctional tool for clinical research in the area of bioelectromagnetism.

The final ranking generated from the execution of WP5 ensures that the stimulus to the development of new devices for the clinical research area on biomedical application of EMF for rehabilitation and palliative medicine is a good option. The current models disregard or are not in full compliance with the needs for a modern standard of clinical research in order to significantly reduce bias in the collection and interpretation of data or scientific controversies, favoring replicability and increasing the credibility of the technology for application in humans. As a contribution to new studies in the field, translational research need to be encouraged for new understanding and identification of more criteria to improve the use results from this tecnology and it is suggested that developing new models of equipment for the biomedical application of EMF in greater harmony with these exposed criteria seems to be the best option for researchers who want to conduct more reliable clinical research.

While our study provides valuable insights, it also opens new questions about the long-term effects of EMF treatments, highlighting the need for ongoing research to explore these therapies' full potential and limitations.

This study's success underscores the indispensable value of interdisciplinary collaboration, merging insights from physics, engineering, and medicine to forge new pathways in the understanding and application of EMF devices. An example of observed methodological bias includes the inconsistent application of EMF intensities across studies, which could skew results and hinder comparability, emphasizing the necessity for standardized protocols. Our findings suggest that the integration of EMF therapies, particularly those modeled after the proposed fictitious device, could revolutionize patient care by offering non-invasive, cost-effective alternatives to traditional treatments. Moving forward, it is imperative to navigate the ethical and regulatory landscape carefully, ensuring that the deployment of EMF devices in clinical settings is both safe for patients and compliant with medical standards. Future investigations should aim to elucidate the long-term effects of EMF therapy on chronic conditions, potentially offering insights into its sustainability as a treatment modality. Contrasting our findings with the existing body of literature reveals a pressing need for a unified methodological framework in EMF research, which our proposed model seeks to address. By providing a systematic evaluation of EMF devices, our study contributes a critical voice to the ongoing debate, advocating for evidence-based practices that could demystify the field for the scientific community and the public alike. Our analysis further illuminates how environmental factors, including the biofield of both practitioner and patient, play a critical role in the efficacy of EMF treatments, challenging the field to consider these variables in future research designs. The introduction of a fictitious model, scoring significantly higher than existing devices, serves as a conceptual breakthrough, indicating the potential for innovative designs that could surpass current limitations in EMF therapy.

This study employed a translational research approach using the work breakdown structure (WBS) [41]. The WBS method divides a process into smaller tasks defined in work packages (WP) and provides a detailed analysis of biophysical and cultural influences on healing. Each WP was designed to examine a specific aspect of knowlodge to Development of Electromagnetic Devices for Rehabilitation and Palliative Medicine the interaction between electromagnetic fields and biological systems, resulting in a complex, multidisciplinary understanding of the subject. The study was organized into six interrelated WPs. The organization was structured in 6 interconnected WPs (Figure 2). The specific objectives of each WP are listed in Table 11, and the specific methodology for each WP in Table 12.

[Figure 2]

[Table 11]

[Table 12]

The WP2 carried out from an integrative literature review, provided the logic underlying the principles and strategies for the realization of WP4 and WP5, validated by WP3. This interaction among the 4 WPs supported the identification of all points of standardization of the device for an adequate collection of clinical data with reduced bias due to the minimal electromagnetic exposure of the environment, avoiding direct contact with researchers (and the influence of their biofields).

Achieving the specific objectives of WP3 was a complex activity because the main limitations of research on electromagnetic technology are strongly inherent to its physical principles of operation [51]. Thus, the development of innovative and intelligent tools is necessary to optimize the entire research process to satisfy clinical demand [36]. Currently, there are no comprehensive, agreed and universally applicable guiding principles and criteria that manage the rigor in the design, conduct and analysis of clinical research of electromagnetics in biomedical applications [5, 8]. There are only safety limits suggested by independent organizations, such as the International Commission on Non-Ionizing Radiation Protection [52].

One crucial aspect that merits emphasis in this current methodology involves the criteria selected in WP3 and WP4. In these Work Packages, an interdisciplinary approach was adopted for developing guiding principles aimed at enhancing the robustness of clinical research in biomedical applications of electromagnetic devices. Inspired by the principles of Design Thinking and Open Innovation, we structured an iterative and collaborative process for the definition and refinement of evaluation criteria. This methodology is outlined in five main phases summarized in Table 13.

[Table 13]

Through this methodology, the aim was not only to develop robust evaluative criteria for clinical research on electromagnetic devices but also to foster a culture of collaboration and continuous innovation. By actively engaging a broad range of stakeholders in the development process, we ensured that the criteria are comprehensive, inclusive, and aligned with the real needs of end-users and the scientific community. To create a systematized methodology that clarifies the selection and evaluation process of the nine criteria used to assess electromagnetic devices in biomedical contexts, a structured approach incorporating principles of open innovation and creativity can be adopted. This methodology can be divided into several key stages, each contributing to the development of clear, objective, and justified criteria for technological evaluation.

This systematized methodology not only promotes an inclusive and transparent approach to the development of evaluation criteria but also stimulates continuous innovation by adapting to emerging needs and technological advances. Moreover, by incorporating feedback from a variety of stakeholders, including patients, the relevance and applicability of the criteria are enhanced in support of the research and development of electromagnetic devices for biomedical applications

The application of the Analytical Hierarchy Process (AHP) was made in WP5. As reflected in the literature review, this technique, developed during the 70s [20,29], is widely used as a decision model and weightening technique. It is one of the methods of Multicriteria Decision Support widely used in the evaluation of objectives in problems characterized by complexity and subjectivity, mainly due to its easy understanding and possibility of treatment of qualitative and quantitative data [53,54].

Basically, AHP consists of constructing a square matrix (n lines by n rows) of comparisons between criteria, where n is the number of criteria. Each entry of the matrix represents how many times the criterion of the row is more important than the criteria of the column, using a predefined scale that takes values between 1 to 9 (Table 14).

[Table 14]

This comparison matrix presents the elements of the upper diagonal equal to the inverses of the elements of the lower diagonal (since they are the result of reciprocal comparisons between the criteria). Further, the elements of the diagonal are equal to unity (since they represent the comparisons of a criterion with itself). These properties of the matrix make the autovector associated with the dominant autovalue or average characteristic value to constitute the set of weights of the decision problem [55].

This procedure results in an approximation, since, in practice, the researcher makes some inconsistencies when estimating the importance of paired comparisons that implies that the vector of weights will not be completely exact. This way, the methodology also takes into account an estimation of the consistency of the process, which evaluates the goodness of the approximation through the consistency ratio (CR), defined by Equation (1).

where RI is the random consistency index, a parameter established by Saaty [40] based on the size of the paired comparison matrix (Table 15), and CI is the consistency index, obtained by Equation (2).

where is the dominant autovalue of the matrix, and n is the dimension of the matrix. If the CR is greater than 10%, it is recommended to study the problem again and review the judgments made.

[Table 15]

The application of AHP requires the following steps: structuring the criteria and alternatives; collection of judgments; priority calculation; verification of the consistency of the judgment; and the calculation of the global priorities of the alternatives [40, 49].

It is suggested the search for a maximum number of 7 ± 2 elements at each level in order to achieve greater accuracy in comparisons [40, 49]. So, the maximum number of criteria in this study was nine. Further, Ishizaka & Labib [56] suggest the use of brainstorming with experts and/or bibliographic review to elucidate the criteria and objectives, which was done in WP4 of t his study.

To carry out the judgment, authors used the Saaty’s fundamental scale (Table 2) similarly to the application of the Likert scale, to assign the scores and weights of each criterion in an exploratory way according to the data obtained in WP3 and WP4, facilitating the establishment of hierarchies.

In this study, real alternatives were compared with a fictitious one that corresponds to an idealized project, not completely elaborated or, still, in a mental construction process. The inclusion of one reflexion about a new device (called NEW) was made because those real devices still preserve the existence of scientific controversy – some arguments associated them with quackery [57,58] – about their use.

Acknowledgments

We extend our deepest gratitude to Prof. Dr. Carlos Ernesto Garrido Salmon for his unwavering support and valuable suggestions.

Acknowledgements

Author contributions

Conceptualization, J.F.P.G, F.P.G., R.C.B, A.R.-P., E.M.S., L.F.D.L, C.B.R and J.C.M.S.; Methodology, J.F.P.G, F.P.G., R.C.B, A.R.-P., E.M.S., C.B.R and J.C.M.S.; Figures, J.F.P.G, F.P.G., R.C.B, A.R.-P., E.M.S., C.B.R and J.C.M.S.; Tables, J.F.P.G, L.F.D.L, C.B.R and J.C.M.S.; Formal analysis, J.F.P.G, F.P.G., R.C.B, A.R.-P., E.M.S., L.F.D.L, C.B.R and J.C.M.S.; Writing—original draft preparation, J.F.P.G, F.P.G., R.C.B, A.R.-P., E.M.S., L.F.D.L, C.B.R and J.C.M.S.; Writing—review and editing, J.F.P.G, F.P.G., R.C.B, A.R.-P., E.M.S., L.F.D.L, C.B.R and J.C.M.S.; Visualization, J.F.P.G and L.F.D.L; supervision, J.F.P.G and L.F.D.L.

Funding

Not applicable.

Availability of data and materials

The data that supported the fndings of the present work are available from the corresponding author upon reasonable request.

Ethics approval and consent to participate

Not applicable.

Informed consent

Informed consent was obtained from all subjects involved in the study.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no conficting interests.

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Table 1 Specific objectives for each WP

WP	Objectives
WP1 – Management and supervision	To stimulate the "Team Up", including new collaborators for an adequate interdisciplinary project elaboration; To ensure the correct functioning of the project and its completion based on the objectives and schedule initially outlined; To conducted a thorough literature review, setting criteria to include a broad range of studies in line with the commitment to diverse perspectives and scientific evidence. It was focused on project management and supervision to ensure the proper execution of the project according to its objectives and timeline, encourage teamwork using open innovation, monitor and modify each WBS as necessary, establish reliable communication channels between WPs, and evaluate the impact of new proposals.
WP2 – Analysis of historical data	To run a retrospective analysis of grouped historical data; To assimilate the basic concepts involved in the study; To know the theories involved in understanding the therapeutic action; To recognize the current modus operandi of the biomedical application of electromagnetism with a focus on identifying the diversity of medical device models that emit current electromagnetic energy; To analyze the device use.
WP3 – Development of guiding principles to improve the robustness of clinical research	To develop a generic structure of simple principles and criteria to support that a device is able to increase the robustness and efficiency of these investigations to standardize data collection and offer the possibility of future systematic reviews.
WP4 – Selection and exploratory evaluation of criteria	To select the criteria and assign weights in an exploratory way for further development of the WP5.
WP5 – Application of the Analytical Hierarchy Process (AHP) method	To apply the steps of an AHP methodology for a ranking of alternatives.
WP6 – Publication of results	To present the results of this research in environments those integrate the scientific community to allow social learning and the provision of information to researchers from around the world in search of investments.

Table 2 Specific methodology for each WP.

WP	Specific Methodology
WP1	Present in all WPs, WP1 used fixed parameters to check activities. Such parameters were based on the MOOSE recommendations [15].
WP2	It was carried out from an integrative literature review [16]. The main search sources were LILACS, Medline, Web of Science, Scopus, SciELO, Google Scholar, Research Gate, ClinicalTrials.gov and Prospero; The period defined was 1970 to 2020 because it was able to concentrate the largest number of consistent publications on the topic in question; To support the selection of data, expert consultants in the area of Engineering, Physics and Design were included to assist in the selection of articles and project development; The selection of articles occurred in a standardized manner according to the classification of Oxford Center [17], ensuring methodological rigor; The selection criteria for articles were adapted from Khan et al. [18]; Another focus of data collection focused on the Engineering area regarding existing models of medical devices emitting electromagnetic fields and included the analysis of several patents for specific medical devices in this subarea through Patentscope.
WP3	From a documentary research [19], documents were selected, and the principles of Design Thinking was applied.
WP4	Using Open Innovation another source of data collection used came from informal interviews with expert volunteer consultant [20], and the principles of Design Thinking was applied.
WP5	The inclusion of the study of fundamentals of CAM is emphasized in order to substantiate the importance of organizing an environment of sensory integration and that was able to stimulate the patient's relaxation and better acceptance of the application of EMFs. For the attribution of the scores and weights in the analysis of the devices, the SMART methodology developed from Peter Drucker [21] was used. The application of AHP [22,23]
WP6	Follow orientations by Mack [24].

Table 3 Steps to development of WP3 and WP4

Step	Description
Empathy and Definition:	In this study, interdisciplinarity and external collaborations were essential to shaping our methodology, particularly in the initial phase of developing the evaluation criteria. The contribution of a professor from the Medical Physics department of USP in Ribeirão Preto was a turning point, enriching our understanding of the physical applications of electromagnetic devices in medicine. This collaboration not only deepened our knowledge but also influenced the inclusion of criteria that capture the physical and technical complexity of the field. This experience reiterates the importance of interdisciplinary dialogue and open innovation in advancing scientific research, highlighting the positive impact of external contributions on refining our approach.
Ideation:	Based on the insights gathered, we organized brainstorming sessions, encouraging open and creative participation from all involved. We used Open Innovation techniques to broaden the search for solutions, including online platforms that allowed for the contribution of ideas by individuals globally. This collaborative process resulted in a wide variety of ideas for potential evaluation criteria, as well as methods for implementation and validation.
Prototyping and Testing:	The most promising ideas were selected to develop prototypes of evaluation criteria, which for the purposes of this research were called NEW.
Criteria Development:	Integrating the feedback and lessons learned during the testing phase, we consolidated a set of robust and adaptable evaluation criteria. Each criterion was developed to specifically address the challenges identified in the empathy phase, ensuring they are relevant and applicable to the diversity of contexts in clinical research of electromagnetic devices.
Implementation and Continuous Iteration:	The final criteria were formalized and integrated into our research process. However, recognizing the continuous evolution of technology and clinical needs, we established a continuous feedback mechanism with stakeholders to regularly review and update the criteria. This process of continuous iteration ensures that our methodology remains relevant and effective in the face of technological advances and changes in the health landscape.

Table 4 The Saaty fundamental assessment scale [22]

Intensity on an Absolute Scale	Definition	Explanation
1	Equally important.	Two activities also contribute to the objective.
3	Moderate importance over any other.	Experience and judgment strongly contribute in favor of one activity over another.
5	Essential or strong importance.	Experience and judgment strongly contribute in favor of one activity over another.
7	Very strong importance.	An activity is considered favorable and its dominance is considered extremely in practice.
9	Extremely important.	Dominance is over other attribute is the greatest possibility of providing a statement.
2, 4, 6, 8	Intermediate values between the two judgments.	When this leveling is important.

Table 5 Values of Random Consistency Index (RI) [22].

(Number of elements on the main diagonal)

(Random Consistency Index)

0.52

0.89

1.11

1.25

1.35

1.40

1.45

1.49

Table 6 Conclusion of the research with the descriptors “electromagnetic” and “fields” (NIH, 2020)

Content	Amount
Studies found	80 studies (100%)
Epidemiological studies	7 studies (8.75%)
Used as a guide/diagnostic tool	1 study (1.25%)
Human Clinical Research	72 studies (90%)

Table 7 Profile of sponsors of clinical research of electromagnetics in biomedical applications on the website clinicaltrials.gov [51]

Sponsor	Amount
Universities, Hospitals or Clinics	38 studies (52%)
Companies or Independents	34 studies (48%)

Table 8 Current status of clinical research on electromagnetism at clinicaltrials.gov [51]

Status	Amount
Completed Completed with published results Completed with results published only on clinicaltrials.gov	28 studies (38.87%) 25 studies (89.2%) 3 studies (10.8%)
Inconclusive	24 studies (33.33%)
Open	20 studies (27.8%)

Table 9 Heterogeneity of the conditions or illnesses of 72 clinical studies of electromagnetics in biomedical applications at clinicaltrials.gov [51.

Condition or Illness	Amount
Pain in several different pathologies (such as diabetes mellitus and fibromyalgia) and conditions (such as postoperative or chronic patients)	24 studies (33.33%)
Cancer	8 studies (11.11%)
Osteoarthritis	8 studies (11.11%)
Aesthetics	5 studies (7%)
Neuronal Regeneration in the Central Nervous System	5 studies (7%)
Fractures	4 studies (5.55%)
Bone and/or Muscle Rehabilitation	4 studies (5.55%)
Healing	3 studies (4.16%)
Neuronal Regeneration in Peripheral Nervous System	2 studies (2.77%)
Depression	2 studies (2.77%)
Chemical Sensitivity	1 study (1.37%)
Cerebral Hemodynamics	1 study (1.37%)
Physical Conditioning	1 study (1.37%)
Urinary incontinence	1 study (1.37%)

Table 10 Comparison between physical and determining factors for bioelectromagnetic response in literature and in ideal concept to increase scientific realibility on devices

Factors in Literature

Factors considered essential to increase scientific reliability on devices

Biological factors:

Cellular Bio-factors; Tissue Bio-factors; Animal Bio-factors.

Biological factors in relation to the patient:

They show concern for the individual; There is a need for a clinical preparation protocol before application in order to leave research participants in a more physically balanced situation as possible, as the criteria listed next to them are impossible to be controlled in clinical studies.

Biological factors in the literature must also be taken into account.

Physical factors:

Primary EMFs; Secondary EMFs; Passive electrical properties; Endogenous electrogenic events.

Physical factors in relation to the researcher:

Because it is considered a source of bioenergy with potential to influence the participant.

Physical factors in relation to the environment:

There must be electromagnetic restriction to avoid the influence of other electromagnetic fields.

Physical factors in relation to the device in itself:

Multifunctionality to allow the customization of EMF that should be studied.

Physical factors in the literature must also be taken into account.

Table 11 Weights defined in an exploratory way for the selected criteria and their justifications

Criterion	Priority*	Justification
1. Avoid the influence of the researcher or his team's biofield.	5	There is scientific evidence that a therapist's biofield can therapeutically influence the patient, such as through therapeutic touch. This technique is not necessarily associated as the name suggests with touch, but the proximity of the hands.
2. Avoid exposure to other sources of EMF from electrical equipment or motors.	9	There is no way to scientifically assess the biological influence of magnetic fields of any frequency if electromagnetic contaminants are not taken into account. This produces data collection biases in research that hinder its replicability, creating a constant space for controversy.
3. Avoid the influence of natural geomagnetism.	3	There are scientific studies of recording biological effects of subtle magnetic fields and several hypotheses of influence of terrestrial geomagnetism on biological systems. Equipment showing concern for this topic shows scientific maturity.
4. Stimulate the individual's relaxation and well-being.	5	The influence of EMF seems to be associated with adequate user relaxation.
5. Be multifunctional.	3	It would be easy to carry out scientific research and greater clinical applicability if the same equipment were multipurpose.
6. Have broad clinical applicability.	7	It would be easy to carry out scientific research and greater clinical applicability if the same equipment is capable of having a wide range of clinical indications.
7. Allow active and sham mode.	9	Fundamental characteristic for the research environment.
8. Allow the simultaneous use of aqueous colloidal solution.	1	Many devices use the colloidal aqueous or gel solution for their effective biological influence.
9. Have low cost.	9	Economic reflections are essential for the correct choice of equipment.

* Score attributed by the Saaty scale [22] applied as a Likert scale.

Table12 Score of each criterion for each equipment under evaluation*

Device	Score
Device	C1	C2	C3	C4	C5	C6	C7	C8	C9
TENS	1	1	1	2	1	2	1	9	9
PEMF	1	1	1	3	1	7	5	1	5
TDCs	1	1	1	3	1	3	1	9	7
TMS	1	1	1	3	1	3	9	2	3
NEW	5	9	3	5	3	7	9	5	1

* Score attributed by the Saaty scale [22] applied as a Likert scale.

Table 13 Comparison matrix for each criterion*

Criterion	Device	TENS	PEMF	TDCs	TMS	NEW	Auto Vector	Normalized Vector (%)
C1	TENS	1.00	1.00	1.00	1.00	0.20	0.72	11.11
	PEMF	1.00	1.00	1.00	1.00	0.20	0.72	11.11
	TDCs	1.00	1.00	1.00	1.00	0.20	0.72	11.11
	TMS	1.00	1.00	1.00	1.00	0.20	0.72	11.11
	NEW	5.00	5.00	5.00	5.00	1.00	3.62	55.56
	TOTAL	9.00	9.00	9.00	9.00	1.80	6.52	100.00
C2	TENS	1.00	1.00	1.00	1.00	0.11	0.64	7.69
	PEMF	1.00	1.00	1.00	1.00	0.11	0.64	7.69
	TDCs	1.00	1.00	1.00	1.00	0.11	0.64	7.69
	TMS	1.00	1.00	1.00	1.00	0.11	0.64	7.69
	NEW	9.00	9.00	9.00	9.00	1.00	5.80	69.23
	TOTAL	13.00	13.00	13.00	13.00	1.44	8.38	100.00
C3	TENS	1.00	1.00	1.00	1.00	0.33	0.80	14.29
	PEMF	1.00	1.00	1.00	1.00	0.33	0.80	14.29
	TDCs	1.00	1.00	1.00	1.00	0.33	0.80	14.29
	TMS	1.00	1.00	1.00	1.00	0.33	0.80	14.29
	NEW	3.00	3.00	3.00	3.00	1.00	2.41	42.86
	TOTAL	7.00	7.00	7.00	7.00	2.33	5.62	100.00
C4	TENS	1.00	0.67	0.67	0.67	0.40	0.65	12.50
	PEMF	1.50	1.00	1.00	1.00	0.60	0.98	18.75
	TDCs	1.50	1.00	1.00	1.00	0.60	0.98	18.75
	TMS	1.50	1.00	1.00	1.00	0.60	0.98	18.75
	NEW	2.50	1.67	1.67	1.67	1.00	1.63	31.25
	TOTAL	8.00	5.33	5.33	5.33	3.20	5.22	100.00
C5	TENS	1.00	1.00	1.00	1.00	0.33	0.80	14.29
	PEMF	1.00	1.00	1.00	1.00	0.33	0.80	14.29
	TDCs	1.00	1.00	1.00	1.00	0.33	0.80	14.29
	TMS	1.00	1.00	1.00	1.00	0.33	0.80	14.29
	NEW	3.00	3.00	3.00	3.00	1.00	2.41	42.86
	TOTAL	7.00	7.00	7.00	7.00	2.33	5.62	100.00
C6	TENS	1.00	0.29	0.67	0.67	0.29	0.52	8.78
	PEMF	3.50	1.00	3.50	2.33	1.00	1.96	33.34
	TDCs	1.50	0.29	1.00	3.00	0.29	0.82	13.96
	TMS	1.50	0.43	0.33	1.00	0.43	0.62	10.58
	NEW	3.50	1.00	3.50	2.33	1.00	1.96	33.34
	TOTAL	11.00	3.00	9.00	9.33	3.00	5.86	100.00
C7	TENS	1.00	0.20	1.00	0.11	0.11	0.30	4.00
	PEMF	5.00	1.00	5.00	0.56	0.56	1.50	20.00
	TDCs	1.00	0.20	1.00	0.11	0.11	0.30	4.00
	TMS	9.00	1.80	9.00	1.00	1.00	2.71	36.00
	NEW	9.00	1.80	9.00	1.00	1.00	2.71	36.00
	TOTAL	25.00	5.00	25.00	2.78	2.78	7.52	100.00
C8	TENS	1.00	9.00	1.00	4.50	1.80	2.36	34.98
	PEMF	0.11	1.00	0.11	0.50	0.20	0.26	3.89
	TDCs	1.00	9.00	1.00	4.50	1.80	2.36	34.98
	TMS	0.22	2.00	0.22	1.00	0.67	0.58	8.61
	NEW	0.56	5.00	0.56	1.50	1.00	1.18	17.55
	TOTAL	2.89	26.00	2.89	12.00	5.47	6.74	100.00
C9	TENS	1.00	1.80	1.29	3.00	9.00	2.29	36.00
	PEMF	0.56	1.00	0.71	1.67	5.00	1.27	20.00
	TDCs	0.78	1.40	1.00	2.33	7.00	1.78	28.00
	TMS	0.33	0.60	0.43	1.00	3.00	0.76	12.00
	NEW	0.11	0.20	0.14	0.33	1.00	0.25	4.00
	TOTAL	2.78	5.00	3.57	8.33	25.00	6.35	100.00

*All data with RC <10%.

Table 14 Final decision matrix showing the final and normalized weighted sum

	Criteria (%)									Decision Vector
	C1	C2	C3	C4	C5	C6	C7	C8	C9	Decision Vector
Scale	5	9	3	5	3	7	9	3	9	53
SN*	9.43	16.98	5.66	13.21	5.66	13.21	16.98	5.66	16.98	100.00
TENS	11.11	7.69	14.29	12.50	14.29	8.78	4.00	34.98	36.00
	1.05	1.31	0.81	1.18	0.81	1.16	0.68	1.98	6.11	15.08
PEMF	11.11	7.69	14.29	18.75	14.29	33.34	20.00	3.89	20,00
	1.05	1.31	0.81	1.77	0.81	4.40	3.40	0.22	3.40	17.16
TDCs	11.11	7.69	14.29	18.75	14.29	13.96	4.00	34.98	28.00
	1.05	1.31	0.81	1.77	0.81	1.84	0.68	1.98	4.75	15.00
TMS	11.11	7.69	14.29	18.75	14.29	10.58	36.00	8.61	12.00
	1.05	1.31	0.81	1.77	0.81	1.40	6.11	0.49	2.04	15.78
NEW	55.56	69.23	42.86	31.25	42.86	33.34	36.00	17.55	4.00
	5.24	11.76	2.43	2.95	2.43	4.40	6.11	0.99	0.68	36.99

* SN: Scale Normalization.

Table 15 Final ranking of devices for biomedical application of electromagnetism

Device	Position	Percentage
NEW	1^st	36.99
PEMF	2^nd	17.16
TMS	3^rd	15.78
TENS	4^th	15.08
tDCs	5^th	15.00

No competing interests reported.

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Translational Insights for the Development of Electromagnetic Devices for Rehabilitation and Palliative Medicine: An Analytical Hierarchy Process Contribution

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