End-User Assessment of an Innovative Clothing-Based Sensor Developed for Pressure Injury Prevention: A Mixed-Method Study

This study aimed to evaluate a clothing prototype that incorporates sensors for the evaluation of pressure, temperature, and humidity for the prevention of pressure injuries, namely regarding physical and comfort requirements. A mixed-method approach was used with concurrent quantitative and qualitative data triangulation. A structured questionnaire was applied before a focus group of experts to evaluate the sensor prototypes. Data were analyzed using descriptive and inferential statistics and the discourse of the collective subject, followed by method integration and meta-inferences. Nine nurses, experts in this topic, aged 32.66 ± 6.28 years and with a time of profession of 10.88 ± 6.19 years, participated in the study. Prototype A presented low evaluation in stiffness (1.56 ± 1.01) and roughness (2.11 ± 1.17). Prototype B showed smaller values in dimension (2.77 ± 0.83) and stiffness (3.00 ± 1.22). Embroidery was assessed as inadequate in terms of stiffness (1.88 ± 1.05) and roughness (2.44 ± 1.01). The results from the questionnaires and focus groups’ show low adequacy as to stiffness, roughness, and comfort. The participants highlighted the need for improvements regarding stiffness and comfort, suggesting new proposals for the development of sensors for clothing. The main conclusions are that Prototype A presented the lowest average scores relative to rigidity (1.56 ± 1.01), considered inadequate. This dimension of Prototype B was evaluated as slightly adequate (2.77 ± 0.83). The rigidity (1.88 ± 1.05) of Prototype A + B + embroidery was evaluated as inadequate. The prototype revealed clothing sensors with low adequacy regarding the physical requirements, such as stiffness or roughness. Improvements are needed regarding the stiffness and roughness for the safety and comfort characteristics of the device evaluated.


Introduction
Quality of life is significantly impacted by pressure injuries (PIs), which are an important risk factor for morbidity and mortality rates, namely among bedridden people and/or people with reduced mobility (RM) [1][2][3]. Alongside the impact on patient outcomes and care experience, PIs account for a significant socioeconomic burden with increased admission periods and an increase in the complexity of care and related costs [3,4].
PIs usually affect tissue composition in extension and depth. They progress rapidly and are caused by pressure, friction, and shearing forces from the continuous use of Thus, this research aimed to evaluate the physical and comfort requirements of a prototype of pressure, temperature, and humidity sensors to be integrated into clothing to prevent the occurrence of PIs.

Study Design
A mixed-method study was conducted using concurrent data triangulation [38] and following the guidelines of the Mixed Method Appraisal Tool (MMAT) [39] (Figure 1).
The mentioned methods directed to smart clothing sensors and their development have a scarce presence within the scientific literature. Thus, this study aims to ensure that the device under development meets the needs and preferences of its final users, making it more likely to be used consistently and effectively and thus contributing to user safety [33][34][35][36][37].
Thus, this research aimed to evaluate the physical and comfort requirements of a prototype of pressure, temperature, and humidity sensors to be integrated into clothing to prevent the occurrence of PIs.

Study Design
A mixed-method study was conducted using concurrent data triangulation [38] and following the guidelines of the Mixed Method Appraisal Tool (MMAT) [39] (Figure 1). The mixed method was used to complement the topic under study and determine the main convergences, divergences, and integration between the quantitative and qualitative assessments conducted [38,39]. The mixed method was used to complement the topic under study and determine the main convergences, divergences, and integration between the quantitative and qualitative assessments conducted [38,39].

Study Setting
The study was developed at the Health Sciences Research Unit: Nursing (UICISA: E), and data were collected at the facilities of the Nursing School of Coimbra (ESEnfC), Portugal. The stakeholder meeting and sequential methodological implementation (QUAN + QUAL) were carried out to pursue the planned strategy [38].

Participants and Recruitment
For the evaluation process, nursing professionals with knowledge, skills, and experience in caring for people with RM and/or bedridden people were recruited. Eligible participants were those nursing professionals who presented at least two of the following criteria: research on the development of preventive and/or health promotion actions aimed at people with RM and/or bedridden people [40].
Nursing professionals were recruited to participate through an active search for contacts and invitation letters to establish a convenience sample. Nine nursing professionals active in teaching, research, and/or assistance, in the areas of rehabilitation, intensive care, long-term care, general nursing, oncology, and medical or surgical settings, participated in the evaluation process.

Description of the Sensor Prototype
The sensors were developed by the International Iberian Nanotechnology Laboratory (INL), located in Braga (Portugal), a member of the 4NoPressure project consortium, considering the textile interface under development by Impetus Portugal-Têxteis S.A. (IMPETUS). INL promoted the progress of material requirements and sensor models.
The hardware with individual sensors was developed, considering the design and modeling of devices, composed of micro-and nanomaterials, with properties of design and compliance. This prototype was subjected to a test phase for ergonomic evaluation related to comfort and convenience, considering user-centered design [26][27][28][29][30][31][32].
The target application of the prototype presented specificities regarding the shape and mechanical and physical characteristics of the sensors, namely flexibility with a high and low thickness (to minimize the topography when integrating the textile substrate). One explored approach used a polyimide (PII) substrate to build the pressure and temperature sensors. PII is a polymeric substrate compatible with microfabrication techniques for the production of thin-film sensors [51], such as tactile, pressure [52], and humidity sensors, being capacitive [53] or resistive [54]. Furthermore, the degree of biocompatibility and skin compliance [55] was also considered.
Regarding the transduction mechanisms explored and implemented in the prototype, resistance temperature detectors (RTDs) were selected for temperature assessment, while both capacitive and resistive sensors based on flexible membranes were selected for the pressure sensors. Resistive pressure sensors are based on contact area variation between two conductive plates (due to deformation) [56].
Different formulations of silicone elastomers were tested for direct attachment of the PII sensors to the fabric. Ecoflex was selected for its easy preparation and application and for the resulting mechanical characteristics, such as elasticity. PII is a humidity-absorbing material. Wrapping it in elastomers also confers protection by stabilizing the sensor properties [51].
As for the connection with the conductive fibers, besides the direct sewing on the contacts with the sensor and the use of conductive adhesives (epoxy with silver particles), a connection method using a flexible printed circuit board (Flex PCB) was also incorporated into the prototype. In this alternative, the electrical contacts of the thin-film sensor are not perforated by the stitching. Still, they are connected to standardized contacts on the Flex PCB using a tape with transverse electrical conductivity (also known as z-tape) while stitching is performed on the contacts of the Flex PCB [57]. These two approaches were implemented to comparatively evaluate their robustness and reliability.
The conductive wire used was a polyethylene terephthalate (PET) yarn, silver-coated using plasma technology, with 78 Dtex and a conductivity of 1.3 Ω/cm. To attach the Flex PCBs to the fabric, a thermoplastic mesh composed of aliphatic polyurethane ester was used [58]. Figure 2 illustrates the sequence of stitching the Flex PCBs, the assembly of the sensors on the Flex PCB, and the stages and areas of the Ecoflex application. The textile substrate and the conductive yarn, as well as the thermal fixation of the Flex PCBs to the fabric and the stitching, were selected by the Institute for Innovation in Fiber and Composite Materials (FIBRENAMICS).
while stitching is performed on the contacts of the Flex PCB [57]. These two approaches were implemented to comparatively evaluate their robustness and reliability.
The conductive wire used was a polyethylene terephthalate (PET) yarn, silver-coated using plasma technology, with 78 Dtex and a conductivity of 1.3 Ω/cm. To attach the Flex PCBs to the fabric, a thermoplastic mesh composed of aliphatic polyurethane ester was used [58]. Figure 2 illustrates the sequence of stitching the Flex PCBs, the assembly of the sensors on the Flex PCB, and the stages and areas of the Ecoflex application. The textile substrate and the conductive yarn, as well as the thermal fixation of the Flex PCBs to the fabric and the stitching, were selected by the Institute for Innovation in Fiber and Composite Materials (FIBRENAMICS). The textile substrate used was a jersey-knitted fabric with 0.74 mm of thickness and 281 g/m 2 of mass per unit area. Contact with the skin was made through a mixture of cotton yarns with Outlast viscose and, on the external side, a mixture of polyamide (PA) and modal (MO). The choice of using Outlast viscose is justified because the Outlast The textile substrate used was a jersey-knitted fabric with 0.74 mm of thickness and 281 g/m 2 of mass per unit area. Contact with the skin was made through a mixture of cotton yarns with Outlast viscose and, on the external side, a mixture of polyamide (PA) and modal (MO). The choice of using Outlast viscose is justified because the Outlast technology is distinguished by having incorporated microcapsules with phase-changing materials (PCMs) into its fibers, which contribute to the thermophysiological comfort [59].

Data Collection Instruments and Procedures
Data collection took place in April 2022. The prototype's quality indicators in terms of the suitability of the Flex PCB and Ecoflex coated sensors were assessed using a questionnaire developed by the research team. Consideration was given to the physical and comfort properties and the suitability of the embroidery in relation to its limitation, flexibility, and comfort, which are potential risks when in contact with the skin. The theoretical rationale was based on published scientific studies on the biomechanics of medical devices and their cause/effect on the incidence of PIs, with questions regarding stiffness, roughness, imprinting, comfort, and size [60][61][62][63].
As this is a primary prototype to be evaluated and validated, new iterations will be subsequently evaluated by participants until a consensus is reached in order to develop a final version. The prototypes were divided into three main parts for evaluation: Prototype A: PII sensor coated in a protective layer of Ecoflex + embroidery; Prototype B: polyimide sensor coupled with Flex PCB + embroidery; Prototype A and B: specifically, regarding only the embroidery, which is not evaluated regarding its dimension because there was no final prototype to be tested that determines the evaluation of its size on the clothing ( Figure 3).

Data Analysis and Treatment Procedure
Data were analyzed using the Statistical Package for the Social Sciences (SPSS) software, version 24 (SPSS Inc., Chicago, IL, USA). To obtain results on the quality of the in dicators, descriptive analysis was conducted to determine the mean scores of the items assessed. The analysis also integrated the evaluation of the confidence interval at 95% and the standard deviation (SD), which allowed calculating the coefficient of variation, obtained by dividing the SD by the mean of responses and multiplying it by 100, which is a standardized measure of dispersion that determines the precision of the distribution and the variability of responses, for which values below 20% are considered ideal [40]. Ken dall's coefficient of concordance was used for the ordinal Likert scale classifications. Results above 0.7 were considered a high correlation of concordance between the evaluators [67], and the value of p < 0.05 was established as statistical significance for all analyses.
The data from the "QUAL" evaluation were transcribed using MAXQDA software Questionnaires were rated on a five-point Likert scale ("1-inadequate"; "2-slightly adequate"; "3-moderately adequate"; "4-adequate"; "5-very adequate"). The participants completed this first stage independently, with the prototype available for viewing and evaluation.
The FG technique was used for data collection, in which nine participants discussed and inquired about the usability and sensory perception of the prototype component presented as to its physical characteristics and the care settings considering the target population, as well as its advantages and disadvantages [64]. Nevertheless, considering health professionals' wide range of performance areas, the contextual factors evoked from each report revealed significant variations in the opinions of the interviewees, which would not be possible to obtain with only the "QUAN" study [65,66].
In the "QUAL" methodology, due to the evaluative objective of the research, the interview guide included open-ended questions in random order, according to the discussion and the opinions being structured and adjusted to the prototype evaluation objective [65,66]. The questions scored were as follows: "Regarding the characteristics of each sensor, which aspects assessed in the quantitative stage do you think should be improved and why?" "What is the contribution of the biomechanics of medical devices to the increase in the incidence of PIs?" The interviews were guided by the main moderator and assistant moderator, who wrote field notes and posed some complementary questions, using the focused interview approach. The moderators allowed exploring the findings that emerged with the group discussion and observations, generating new insights and questions about the evaluated product [65]. The FG speeches were recorded with an Olympus professional audio recorder, model WS-550M.

Data Analysis and Treatment Procedure
Data were analyzed using the Statistical Package for the Social Sciences (SPSS) software, version 24 (SPSS Inc., Chicago, IL, USA). To obtain results on the quality of the indicators, descriptive analysis was conducted to determine the mean scores of the items assessed. The analysis also integrated the evaluation of the confidence interval at 95% and the standard deviation (SD), which allowed calculating the coefficient of variation, obtained by dividing the SD by the mean of responses and multiplying it by 100, which is a standardized measure of dispersion that determines the precision of the distribution and the variability of responses, for which values below 20% are considered ideal [40]. Kendall's coefficient of concordance was used for the ordinal Likert scale classifications. Results above 0.7 were considered a high correlation of concordance between the evaluators [67], and the value of p < 0.05 was established as statistical significance for all analyses.
The data from the "QUAL" evaluation were transcribed using MAXQDA software version 20, read in full, and analyzed with the Discourse of the Collective Subject (DCS) technique by mixing them with data from the first analyses extracted from the "QUAN" phase. On reading the transcribed speeches, excerpts relating to key expressions (KEs) were categorized into central ideas (CIs), and prior connections were made according to the elements assessed in the questionnaire. It should be emphasized that in the DCS technique, the CIs are interconnected to the KEs and not to the interpretations of the discourse, which makes up the first three steps of the DCS procedure [68,69].
Similar or complementary CIs were identified, and the KEs relating to the CIs were linked to the categories and coding in the text. The individual speeches were summarized and combined according to the researchers' interpretations to form the speech of the collective subject [69,70]. For the integration of the "QUAN + QUAL" methods, the Joint Display approach [40] was used to present the results.

Ethical Aspects
This study received a favorable review by the Ethics Committee of the UICISA: E of the ESEnfC issued under number 701_07/2020. The participants signed the informed consent form (ICF), which explained the objectives and sequential steps of the study, in two copies of equal content. To preserve anonymity, the participants' reports were identified by the letter E (nurse), followed by the order in which the reports and opinions occurred (e.g., E-01). After the transcriptions, the FG audio recordings were destroyed.

Results
Nine nurses participated in the study, with a mean age of 32.66 ± 6.28 years and a mean of 10.88 ± 6.19 years of nursing practice. The majority were women (55.6%), had a master's degree (33.3%), and were specialists in rehabilitation nursing (33.3%) ( Table 1). All participants were scientific researchers. According to the DCS, friction and prolonged bed rest can generate PI risk associated with the sensor-based device. In the "QUAL" phase, the DCS complemented the specifications of the evaluations, making stiffness and roughness the items with the lowest adequacy (Table 3). Depending on the clinical context of the bedridden people and/or people with RM, these implications make the sensor prototype presented unsuitable or poorly suitable for the clinical context under discussion. The discourse on imprinting or marks that the device may cause on people's skin revealed a KE related to the possibility that alternating decubitus position could cause imprinting due to friction caused by sheets sliding (Table 3).

Friction (KE 48)
The stiffness and roughness of PCB Flex and other elements can damage the skin, which is usually fragile and prone to injury, especially by the time people with RM and/or bedridden people remain in bed and/or chair.
"It is too stiff, considering the clinical context in which the wearers may be admitted... If it is an intensive care unit, we will have problems. For example, in the case of older patients with unstable fractures who need to maintain bed rest. Friction and shear between the skin and sheets will influence the development of

Practicality (KE 17)
The sensor materials showed resistance and roughness, and the wire conductor was considered an uncomfortable material and likely to cause skin injuries.

Width (KE 38)
The size of sensors can increase the risk of injury due to their rigidity and roughness. The anatomical location of the sensors may imply greater matrix width for monitoring a certain area. The participants also discussed new configuration proposals, such as the use of liners over the sensors so that they do not come into direct contact with the skin. These aspects are associated with clothing design and user safety and resulted in low adequacy regarding the physical characteristics of the evaluated device. However, the comfort of the prototype sensors was also considered regarding the practicality of the garment and its usefulness in the provision of clinical care in hospital settings, long-term care, or home care (Table 3).
Embroidery also obtained low values regarding its adequacy as it became uncomfortable because of its lumpy texture. The dimension of the prototype sensors obtained low average values, and in the DSC, questions emerged about the width of the garment and its practicality in changing decubitus position, the anatomical region where the sensors would be placed, and the patient's clinical needs related to mobility and the anthropometric interface (Table 3). Table 4 shows the values of the agreement tests of the participants' assessment, with a Kendall's W of 0.359 (p = 0.039) for roughness and 0.318 (p = 0.022) for imprinting without sliding, interpreted as a moderate concordance among the participants. The other items presented a low coefficient of concordance.

Discussion
This study assessed the usability of one sensor-based prototype (Prototype A and B) designed for PI prevention in people with reduced mobility and/or bedridden patients. The results indicate that Prototype A, which has a PI prevention component covered by a protective layer made of Ecoflex, presented lower mean values of stiffness and roughness, indicating minor suitability. Prototype B, which has a PI prevention sensor component coupled with Flex PCB, showed a lower degree of suitability in terms of stiffness and dimension.
The DCS analysis indicated that friction and prolonged bedrest can generate the risk of PIs associated with the sensor-based device. The DCS complemented the specifications of the evaluations, and it was referred to in the discussions that the prototype was stiff and rough. These implications make the prototype unsuitable for clinical use in the context under evaluation.
The use of commercially available nanomaterials and components indicates that the developed prototype has potential for practical applications. However, further studies on the ergonomic properties of pressure, temperature, and humidity sensors in a single monitoring system are needed. After adjustments, the evaluated prototype will allow for the simultaneous monitoring of these parameters, providing a more complete picture of the observed conditions. Integrating sensors into a single monitoring platform will save space, reduce the number of necessary components and their complexity, and make the system more reliable and cost-effective.
Combining these materials and components resulted in a better understanding and design changes. The use of biocompatible, biodegradable, and self-repairing materials highlights the focus on the safety and sustainability of this evaluated prototype. Table 5 presents the minimum requirements in the literature and the materials used in the pressure, temperature, and humidity sensor prototype developed by the 4NoPressure project.  [41][42][43][44] Non-toxicity [41][42][43] Ecoflex (easy preparation and favorable mechanical properties)

Biodegradable polymer compounds
Mechanical resistance [41][42][43][44] Resistance to washes [43,44] Low coefficient of friction [43] Thermoregulation [34] Humidity management [34] Structural Lightness (low mass per surface unit and low thickness) [42,44] The prototype evaluated in this study consisted largely of polymer substrates. Prospects presented in the literature point to developing polymeric materials with sufficient mechanical properties to withstand friction and shear caused by body movements and/or alternating decubitus [61,71,72].
The versatility of synthetic polymers benefits from mechanical and hydrophobic adjustments for obtaining tough, malleable, waterproof, and/or breathable products at low cost. This diversity also enhances the creation of sensors with properties shaped to the broad physical and chemical functionalization, contemplating the skin microclimate [73][74][75].
Prototype A, with PII covered by a protective layer of Ecoflex, presented the lowest average values of stiffness and roughness, indicating the lowest suitability. The manufacturing method may be responsible for this result. There is limited evidence on using PII in sensors for PI prevention adhered to specific textiles [11,70].
The Ecoflex technology was chosen because it is widely used in other sensors and has excellent mechanical and piezoresistive properties [70]. These properties increase the durability of the device covered by Ecoflex, especially when considering exposure to body fluids and washing clothes [11].
This aspect underscores the importance of considering the end-use environment of a product when selecting materials and designing it. Sometimes, a material that performs well in a controlled laboratory environment may not be suitable for practical use in realworld conditions [11,70].
A study in China developed graphite-based strain sensors coated with Ecoflex. The authors used the substrate for better sensitivity and signal protection, which showed better detection capability and stability after several laboratory experiments. In the clinical context, these have only been used to monitor movement and breathing, and ergonomic comfort requirements have not been explored [76]. Regarding mechanical properties, flexibility and size are specific features that integrate the adequacy of ergonomic comfort. The device's size may become inadequate due to postural changes and increased risk of PIs caused by skin contact pressure with the developed device [41][42][43][44]77].
McNeill's study [77] used similar models to measure temperature, humidity, and pressure in a small and flexible size. The study highlighted the advantages of the device in terms of size and durability. The authors did not provide information on how the device should be applied to the skin, nor did they address any issues related to the manufacturing process and cost [77].
In an industrial context, studies recommend considering the manufacturing techniques of the substrates, which must follow a specific method for wearable sensors [71,72]. This is because the way substrates are manufactured can affect their performance and durability, as well as their adaptation to different environments and conditions of use [77,78].
In the context of user-centered design, the results can identify issues related to current manufacturing methods, which may not be optimized for the specific needs of the user. The evaluation uncovered that the prototype may be uncomfortable or poorly adjusted, requiring a revision of the project specifications and a reevaluation of the user's requirements.
Based on the requirements in Table 5, elastomers were selected for use in the prototype development due to their mechanical, electrical, and structural properties. RTDs and elastomers can provide a robust solution for measuring temperature in challenging environments [56]. Covering an RTD with an elastomeric material can protect the sensor from environmental factors such as humidity, dust, and other contaminants. This can help to ensure that the RTD operates correctly and provides accurate temperature measurements over time [56,[79][80][81].
The use of elastomers to cover RTDs in temperature sensors can improve the durability and accuracy of the sensor while also providing user-centric ergonomic comfort. By designing sensors with user comfort in mind, manufacturers can create products that are more appealing to end-users and more likely to be adopted in various applications [80][81][82][83].
Shintake [83] described the advantages of using elastomers, which promote greater elasticity, low friction coefficient, and better deformation. Recent studies [80][81][82] reported similar results, highlighting the detection capability and low manufacturing cost.
The classification of the dimension as "slightly adequate" suggests that the evaluators have some concerns about the size of the device and its potential to cause discomfort. The device's design should consider the needs, preferences, and comfort of the user. By involving users in the design process and obtaining feedback on the device's size, form factor, and overall usability, manufacturers can ensure that their devices are accurate, effective, and convenient to use [83,84].
The device size can also be optimized to balance the need for accuracy and sensitivity with user comfort. A study conducted in China reported the development of topological materials that can be embedded in cotton fibers [85]. A similar process is under development by partners of the 4NoPressure project, addressing the need for high sensitivity to signal performance.
The materials used, mostly composed of polymer substrates, are based on the possibility of modification, considering the versatility of synthetic polymers. These characteristics benefit mechanical and hydrophobic adjustments for obtaining resistant, flexible, impermeable, and/or breathable products at a low cost [74,75,85].
Prototypes A and B received criticism from nursing professionals regarding comfort and the need to reduce stiffness and roughness. These prototypes have a Flex PCB, which is highly conductive and composed of metallic and derivative materials, making them less flexible and more uncomfortable [84].
The study addressed the low performance of flexible circuits using Flex PCBs for operational reliability due to the movement of the human body. The study pointed out important technological advances for the development of components, considering flexibility and performance, manufacturing process, and automation [86].
Liman emphasizes the discomfort that the properties of some conductive materials cause on the skin, highlighting the need for intelligent textile manufacturing to meet the requirements for activating electronic components with the application of precise different materials [84]. The results of this study increase the importance of these data and the technological advancement to produce smart textiles for the prevention of PIs.
Researchers from Pakistan used a commercial sensor model. The PCB system was encapsulated with plastic and adhered to a wearable device to determine pressure points in the gluteal region through electrical stimulation. The authors concluded that the model is biocompatible and offers important advances for smart clothing for PI prevention [87]. Thus, the user-centered design emphasizes the need for prototype improvement, considering that the literature presents devices with similar objectives but different comfort characteristics.
Studies have shown that the decision to use specific materials to develop sensors directly impacts their medical properties, interfering with their biocompatibility [81,82,88,89]. Proposals to mitigate the use of uncomfortable materials derive from the careful choice of materials used in substrates to ensure the flexibility of wearable sensors [90] and elevate patient safety [91].
By analyzing the study results and applying user-centered design principles, it is possible to develop new strategies to improve technology in creating sensors for PI prevention. The insights obtained with this methodological approach provide valuable information for researchers, engineers, and healthcare professionals interested in developing PI prevention technologies [92].
A Chinese study reported the use of the traditional user-centered design approach for the development of a wearable device for elderly care. The authors concluded that the methodology is beneficial in terms of problem-solving for nursing professionals. This approach can ensure that devices meet their specific needs and enable them to perform their tasks efficiently and safely [93].
Prototype A and B with specifically evaluated embroidery showed lower average values of stiffness, roughness, and comfort. These results are important for the usercentered design issue. There is evidence of the possibility of developing clothing where modifications of the fabric substrate and woven electronics can be alternatives for recording signals from a type of conductive fabric [11].
The results of the study developed by Ye [94] showed relevant advantages of manufacturing textiles with conductive properties. Textiles can reduce the occurrence of PIs by having a smooth surface and high permeability. The study adds the high sensing capability of sensors integrated into the conductive fabric to pressure signals [94]. The use of conductive fabric with sensors can be an important way to reformulate the prototype evaluated in this research, allowing for the creation of more comfortable and discreet devices for PI prevention.
In addition, the use of new textile technologies can create more efficient and precise sensors, contributing to improving the quality of devices for preventing PIs. Conductive fabrics with sensors and other textile technologies can open new opportunities for research and development of PI prevention devices adaptable to user needs.
PIs are a common and serious problem that can occur in bedridden patients and lead to complications such as infections, pain, and longer hospital stays. The prototype of sensors to monitor pressure, humidity, and temperature, evaluated in the study, can be a promising solution to detect early signs of PIs and prevent their development [4,7,9]. By providing a mixed-methods study, the article offers a comprehensive overview of basic usability requirements related to ergonomic comfort [38,39].
The study is relevant to public health as it contributes to developing wearable and non-invasive technology that can detect pressure injuries in bedridden patients, providing opportunities for better health outcomes. It also provides information about the experiences and opinions of end-users who would use the technology and how they perceive the usability and effectiveness of the technology, as well as greater addition in daily use [95][96][97].
The results of a user-centered design study can be used to develop artificial intelligence (AI) algorithms to improve the design and functionality of products, including those that incorporate pressure, temperature, and humidity sensors. By understanding the needs and preferences of end-users, AI algorithms can be programmed to make decisions that prioritize the user experience and satisfaction [98][99][100].
This study is innovative because it utilizes new sensors that are specifically designed to meet the physical and comfort needs of users for preventing PIs. The study can contribute to promoting new research on the interactions between humans and the environment. The development and evaluation of new technologies, such as the clothing-based sensor, are gradually increasing in current research, and the mixed-methods study provides a comprehensive analysis of the potential impact of the technology on public health.
The development of clothing for PI prevention will be evaluated in terms of design and undergo pre-clinical and clinical tests with end-users. These tests will evaluate the overall characteristics of the clothing in terms of comfort, and specific tests will assess the functionality and conductivity of the sensors. Therefore, the study addressed specific goals, such as material and user requirements, as well as usability, which was evaluated based on the needs of end-users to increase the adoption and acceptance of the platform. Collecting user feedback during the design and development process can help identify problems and areas for improvement. Moreover, ensuring that the sensor platform for PI prevention meets user requirements can contribute to cost-effectiveness.
This research is limited to the evaluative critique of one process as it is still in development, which reduces its generalizability and prevents the generation of case studies of the evaluated items. This limitation is based on clinical tests that have not yet been conducted and robust observations of the components of the target population. Thus, future studies to evaluate the performance of the sensor platform through testing in various environments and use cases can help ensure that it functions as expected and meets the intended specifications for accuracy and reliability.
End-user acceptance scores were considered poor, given the materials used and the mechanical characteristics of the produced prototypes. These scores were especially significant considering the physical design of the prototype and the prospective user comfort. The stiffness and roughness of the plates and the conductive wire (embroidery) were considered inadequate, given the risk of PI development in bedridden people and/or people with RM, which is in line with the intrinsic clinical characteristics of the target population.
Our results confirm the need for substantial prototype development to ensure the development of comfortable, safe, and clinically reliable sensor-based clothing for people with RM and/or bedridden people.
In this way, given the problems associated with the incidence of the pathology of pressure injuries in the population, the care provided is increasingly personalized and these developments will become progressively faster. Thus, the establishment of multidisciplinary teams is essential, as is the involvement of end-users in developing and improving prototypes that can minimize the occurrence of pressure injuries.