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Back to Journal »Chronic Wound Care Management and Research» Volume 8
Efficacy of local auxiliary sliding film in the treatment of crush
Author Kohta M, Nakamura Y, Yunoki S
Published on March 1, 2021, Volume 2021: 8 Pages 1-11
Single anonymous peer review
Editor approved for publication: Professor Marco Romanelli
Masushi Kohta,1 Yoshinori Nakamura,2,3 Shunji Yunoki4 1Medical Engineering Laboratory, ALCARE Co., Ltd, Tokyo, Japan; 2Department of Medical Family Healthcare Center, Shirakawa Branch of Nara Tenri Hospital, Japan; 3Family Healthcare Stress Injury Research Center, Nara, Japan ; 4Biotechnology Group, Tokyo Metropolitan Industrial Technology Research Institute, Tokyo, Japan Mailing address: Masushi Kohta Medical Engineering Laboratory, ALCARE Co., Ltd, 1-21-10 Kyojima, Sumida-ku, Tokyo, 131-0046, Japan Tel 81- 3 -3611-1101 Fax 81-3-3613-6894 E-mail [Email protected] Purpose: This study evaluates the mechanical stress on the human body caused by a new type of secondary dressing used as a local auxiliary sliding sheet to reduce friction and shear forces The effects of the skin, including interface friction and internal shear force and pressure, use a skin model based on polyurethane gel. A case study was conducted to propose the clinical use of local assisted slides for pressure injury treatment in a home care environment. Method: Prepare a polyurethane gel skin model that simulates the mechanical properties of human skin. An experimental model consisting of skin model, main wound dressing, local auxiliary sliding sheet and triaxial tactile sensor was used to perform parallel measurement of interface friction and internal shear force and pressure. The skin model was covered with the following single or combined dressings: group A, silica gel surface absorbent dressing (control); group B, silica gel surface absorbent dressing and film dressing; and group C, silica gel surface absorbent dressing and local auxiliary sliding sheet. Clinically, a female patient (age, 101 years old) suffered from compression injury of the sacrum. The standard primary wound dressing was used and the dressing was wrapped with a local auxiliary sliding sheet. Results: The static and dynamic friction coefficients of group C were significantly lower than those of group A and group B (p<0.05). The shear force detected in the skin model was reduced to approximately 66% and 62% in groups C and A and B, respectively (p <0.05). Clinically, the patient's ulcers are completely epithelialized, and there are no wound-related complications. Conclusion: The local auxiliary sliding sheet significantly reduces the interface friction and internal shear force in the skin model. The results of the case study indicate that the local assisted sliding film may be used for the treatment of pressure injuries in home care. Keywords: pressure ulcer, tissue vitality, dressing, mechanical force, wound care, shear force, friction
Pressure injury is a local skin injury caused by the long-term combined action of mechanical forces (such as friction, shear, and pressure), and is a common chronic wound. 1 These forces acting on the skin can cause soft tissue deformation, followed by ischemic injury, as a common way to eventually lead to ulcers. 2,3 The increase in the incidence or prevalence of stress injuries in medical institutions is closely related to a wide range of socio-economic issues, including hospital clinical quality indicators, quality of life, and medical care financial crises. 4-6 A recent systematic review report stated that the global prevalence rate of pressure injury was 14.8%, during which the prevalence rate was 11.6%, and the average incidence of pressure injury was 6.3%. 7
Friction generally occurs on the skin site interface of individuals at risk of developing pressure injury and/or on the wound site interface of individuals with pressure injury. When the individual drags the body across the surface, the skin and wound area will continue to rub or pull. When an individual is receiving care assistance at the bedside (for example, heading up and repositioning), simple sliding and movement can create additional friction between the bed sheet and the skin/wound area through the clothing/wound dressing. 8-11 This increases the risk of damaging the more superficial tissues, and the pressure shear force is more likely to damage the underlying tissues, leading to further tissue damage, accompanied by delayed wound healing. 12 Repeated friction and pressure on the wound area may cause the surface of the wound to rupture, allowing pathogens to invade and eventually causing secondary infection.
Although friction and shear forces and pressure continue to be generated, the current clinical techniques to reduce these forces are limited. Doctors or nurses can usually check for excessive pressure by sliding their hands between the patient's wound and the bed sheet. Traditionally, nurses lift the patient's body under the constant pressure of the patient's own weight on the bed to protect the wound. 10 Supporting surfaces, such as mattresses and cushions, usually help to disperse excessive pressure on the body. 13 Reduce the friction between each other. Sheets and wound surfaces, soft plastic materials, such as sliding grooves or sheets, can usually be used when changing the patient's position. 1,14 These assistive devices used by doctors or nurses are temporary, but not continuous, effective and may not be sufficient for the prevention and treatment of stress injuries.
Recently, a clinical guideline recommends the use of prophylactic dressings on areas of the skin that are prone to pressure injuries. 1 Several types of dressings, including hydrocolloids with low-friction outer layers and multilayer silicone foam dressings, are commercially available and are used clinically for preventive purposes as standard preventive care. 15-17 The previous evidence from basic research strongly supports the effectiveness of dressings in clinical practice. Matsuzaki and Kishi used an in vitro experimental model to study the decompression properties of silicone foam and thin hydrocolloid dressings under static conditions. 18 In addition, Ohura et al. prepared another experimental model consisting of pig skin and a sensor capable of measuring pressure. And shear force. They report that film and hydrocolloid dressings are more effective than hydropolymer and water cell dressings in reducing shear forces. 12 Call et al. developed a measurement model, which they called the shear displacement method, and evaluated the shear reduction characteristics of multilayer silicone foam dressings. 19
Based on these findings, we hypothesized that in addition to the main wound dressing, the application of materials that reduce mechanical forces may continue to help minimize friction and shear forces on the skin and wound site. In this research, we developed a new material as an auxiliary dressing to reduce friction and shear forces. We constructed an original experimental model to measure interface friction and internal shear and pressure. A case study was conducted to suggest how to use new materials clinically to treat stress injuries in a home care setting.
We prepared a new rectangular (14 × 24 cm), nylon-based non-adhesive single-layer sheet with a silicone coating as a secondary dressing. In this study, a commercially available local auxiliary sliding sheet (TASS®; Family Health Stress Injury Research Center, Nara, Japan) was used and named "TASS". Transparent polyurethane film dressing (Multifix® Roll; ALCARE Co., Ltd., Tokyo, Japan) was also used as a comparative material because it is commonly used as a secondary dressing in wound management. 20 TASS and the film dressings used in this study were 0.08 mm and 0.03 mm, respectively.
We designed a disk-shaped skin model based on polyurethane gel to simulate the thickness, friction and elasticity of the elderly skin. 21-24 To prepare the skin model, we used a commercial two-part composite (Hitohada gel; Exseal Corporation, Gifu, Japan) for curing polyurethane resin. The composition of the skin model is shown in Table 1. Mix the main agent and curing agent thoroughly and pour it into a petri dish (φ50 mm), and place a rectangular Teflon plate (3×12×48 mm3) in the petri dish at a height of 3 mm from the bottom of the petri dish along the equatorial axis Place. Next, heat the petri dish in a chamber at 60°C for 4 hours to complete curing. Remove the molded polyurethane resin from the tray, and pull out the Teflon plate to form a cavity. Coat the surface of the resin with talcum powder to improve the smoothness and complete the skin model (radius 25 mm; height 10 mm) (Figure 1A). Table 1 Composition of polyurethane gel-based skin model Figure 1 Schematic diagram of simulated skin shear test. (A) Photograph of skin model based on polyurethane gel. (B) Principle of operation. (C) Schematic diagram of friction, shear force and compressive stress generated during the simulated skin shear test.
Table 1 Composition of polyurethane gel-based skin model
Figure 1 Schematic diagram of simulated skin shear test. (A) Photograph of skin model based on polyurethane gel. (B) Principle of operation. (C) Schematic diagram of friction, shear force and compressive stress generated during the simulated skin shear test.
Except for the skin model, following the same preparation method as the skin model, we prepared a rectangular polyurethane resin sheet (5×150×180 mm3) with no cavity for the friction test. The only difference is the use of rectangular petri dishes (5 × 150 × 180 mm3) instead of petri dishes. A disk-shaped polyurethane resin (φ, 50 × 10 mm) without a cavity was also prepared for hardness testing.
A hardness meter (Asker C-type; Kobunshi Kenki Co., Ltd., Kyoto, Japan) was used to test the hardness of the skin model. We use disk-shaped polyurethane resin without cavities as the hardness test specimens (n = 3). These data are compared with data from previous research reports on human skin. twenty three
In order to test the smoothness of the skin model, a friction tester (TL20/Tt; Trinity-Lab Inc., Tokyo, Japan) was used. A rectangular polyurethane resin sheet without cavities was used as a sample for smoothness test (n = 5). According to a previous report, 24 friction is the friction against polytetrafluoroethylene (PTFE; 112 g/m2) measured by covering the probe of the tester with a PTFE sheet. The test was carried out under the conditions of a contact pressure of 4 kPa, a sliding speed of 100 mm/s and a sliding stroke of 80 mm.
Friction, shear and pressure are measured using our original test method, called "simulated skin shear test", as shown in Figure 1B. Use 5 × 5 cm silica gel surface absorbent dressing (SI Aid; ALCARE Co., Ltd.) as the standard main wound dressing. The skin models were covered with single or combined dressings as follows: group A, silica gel absorbent dressing (control group); group B, silica gel absorbent dressing plus film dressing; and group C, silica gel absorbent dressing plus TASS. A three-axis tactile sensor (ShokacChip™; Touchence Inc., Tokyo, Japan) was inserted and placed in the center of the cavity already formed in the skin model. According to previous reports, the surface of the sensor is placed 3 mm above the interface of the skin model to simulate the detection of mechanical forces inside the skin tissue of the elderly. 21,22
The interface friction and internal shear force and pressure were measured under the shear deformation caused by pulling the test probe with an adhesion tester (Dage 4000Plus; Nordson Dage, Erkrath, Germany). A wooden platform covered with 100% cotton sheets is fixed on the movable table of the adhesion tester. Place the test probe on the wooden platform so that the skin model is in contact with the bed sheet through the dressing. The test probe is weighed with a lead plate to make the interface pressure reach 100 mm Hg. Use a wire to connect with the sensor of the tester (load cell <50 kgF), and then pull it horizontally on the cotton (x-axis) through the horizontal movement of the stage Move the bed sheet at a speed of 0.5 mm/sec. The tensile force of the test probe and the force of the three-axis tactile sensor (x-axis and z-axis) are recorded in parallel at the same time (Figure 1C).
For data analysis, the static and dynamic friction coefficients are calculated based on the tensile force data of the test probe. In addition, the platform forces detected in the x-axis and z-axis directions under dynamic conditions are defined as internal shear force and pressure, respectively. We excluded the y-axis direction from the data analysis of this study because no force was detected in the axis without sliding motion.
A 101-year-old woman with a major medical history of disuse syndrome was recruited from a home care facility in Japan. The patient usually lies on the bed in a spine position. The patient has a history of d2 pressure injury to the sacrum (ie, the Design-R scoring system defines "d2" as pressure injury deep into the dermis). 25 The traditional pressure redistribution mattress has appeared on her bed. The doctor (YN) speculates that the underlying cause of the development of pressure injury is surface friction and potential shear forces when repeatedly raising the head of the bed. Various types of standard wound care products, including sucrose/povidone iodine ointment, dimethyl isopropyl chamomile ointment, and appropriate wound dressings, have been used to treat this patient; however, before TASS was applied, ulcers Improved repeatedly and relapsed four times. Due to the limited resources of the medical reimbursement system for home care in Japan, it is difficult to obtain more expensive treatment products for the patient. Therefore, doctors decided to try TASS in addition to standard wound care. In this case, the main wound dressing is applied directly to the wound site. Subsequently, the TASS is cut into a wider size than the dressing, and then placed on the dressing. Fix the TASS directly on the skin by sealing the opposite side with two pieces of medical tape (Figure 2). Other techniques, such as wound irrigation for biofilm control, are performed in accordance with the latest clinical guidelines developed by the Japan Pressure Ulcer Association for the treatment of pressure injuries. 26 Figure 2 A photo of the local auxiliary sliding sheet attached to the wound site.
Figure 2 A photo of the partial auxiliary sliding sheet at the wound site.
The data of interface friction and internal shear force and pressure in the simulated skin sharing test are expressed as mean ± standard deviation (SD) (n = 5), and all variables are evaluated as normal distribution by the Kolmogorov-Smirnov test. The statistical significance between groups was assessed by one-way analysis of variance (ANOVA) and Tukey's test. Use Tukey's test for statistical analysis. A p value of <0.05 indicates a statistically significant difference. All statistical analyses were performed using the social science statistical software package version 20.0 (IBM Corporation, Tokyo, Japan).
The thickness, hardness and friction test results of the skin model based on polyurethane gel are shown in Table 1. It was determined from the test results that the most preferred compounding weight ratio of the main agent and the curing agent was 3:1.20 (Sample 2), because the physical properties of the skin model seemed to be comparable to those of the elderly skin. Therefore, Sample 2 was used for the simulated skin shear test in this study.
Figure 3 shows the static and dynamic friction coefficients, which can be expressed as the force generated by the friction between the surfaces divided by the normal force. The static friction coefficients of group A, group B and group C were 0.42±0.03, 0.38±0.02 and 0.18±0.01, respectively. The differences observed between group C, group A and group B were statistically significant (Figure 3A). Figure 3 Static (A) and dynamic (B) coefficients of friction for each test group on 100% cotton sheets. Group A, silica gel absorbent dressing; Group B, silica gel absorbent dressing plus film dressing; and Group C, silica gel absorbent dressing plus local auxiliary sliding sheet. Vertical bars indicate statistically significant differences between samples (*p <0.05).
Figure 3 Static (A) and dynamic (B) coefficients of friction for each test group on 100% cotton sheets. Group A, silica gel absorbent dressing; Group B, silica gel absorbent dressing plus film dressing; and Group C, silica gel absorbent dressing plus local auxiliary sliding sheet. Vertical bars indicate statistically significant differences between samples (*p <0.05).
The dynamic friction coefficients of groups A, B and C were 0.40 ± 0.04, 0.37 ± 0.01 and 0.16 ± 0.01, respectively. The differences observed between group C, group A and group B were statistically significant (Figure 3B).
Figure 4 shows a practical example that involves changes in internal shear force and pressure over time obtained through a simulated skin shear test. In group A, the shear force increased at 0-10 seconds and then reached a near plateau (range, 0.44-0.63 N). A similar trend was observed in group B (range, 0.38-0.61 N). In contrast, the increase in shear force in group C only stopped at 3 seconds and then reached a near plateau (range, 0.26-0.40 N). We visually observed that when the shear force reached the platform, the skin model on the bed sheet began to slide. Figure 4 Representative time-related changes in internal shear force and pressure generated in the skin model during horizontal pulling. A three-axis tactile sensor set in the skin model is used to measure shear force and pressure. (AC) are the data of groups A, B and C respectively.
Figure 4 Representative time-related changes in internal shear force and pressure generated in the skin model during horizontal pulling. A three-axis tactile sensor set in the skin model is used to measure shear force and pressure. (AC) are the data of groups A, B and C respectively.
The curve of pressure versus time is in line with expectations (Figure 4). In group A and group B, the pressure dropped at 0-10 seconds and then stabilized (range 0.75-0.96 N and 0.89-1.17 N, respectively). In contrast, in group C, the intimal pressure (range, 1.14-1.41 N) remained almost constant throughout the measurement.
Figure 5 provides the results of shear force under dynamic conditions. In group C, the platform shear force was approximately 66% and 62% of those in groups A and B, respectively. The differences observed between group C, group A and group B were statistically significant. Figure 5 The internal shear force obtained by the simulated skin shear test. The measurement time range is the average internal shear force within 10 to 40 seconds. Vertical bars indicate statistically significant differences between samples (*p <0.05).
Figure 5 The internal shear force obtained by the simulated skin shear test. The measurement time range is the average internal shear force within 10 to 40 seconds. Vertical bars indicate statistically significant differences between samples (*p <0.05).
Figure 6 shows the time course of wound healing after TASS intervention. At the beginning of the study, sacral pressure injury was observed on d2 (Figure 6A). 5 days of application resulted in complete epithelial formation and reduced wound area (Figure 6B). After the healing process is completed, standard preventive care without TASS is provided to prevent the recurrence of the stress injury. However, 6 months after healing, there was a d2 pressure injury in a similar location in the sacral region (Figure 6C). Reapplication of TASS for 7 days resulted in complete epithelial formation (Figure 6D). The patient did not report any complications related to the wound. In this case, the dressing never came off the tape. Figure 6: The use of primary wound dressing and local auxiliary sliding sheet to treat pressure injuries. (A) A pressure injury of the sacrum that was classified by the Design-R scoring system as d2 (the area extending to the dermis) was produced. (B) The partial auxiliary sliding sheet was used for 5 days. (C) A new d2 pressure injury was created at a similar location in the sacrum. (D) The external auxiliary sliding sheet was re-attached to the wound site through the dressing for 7 days; then the epithelialization was completed.
Figure 6: The use of primary wound dressing and local auxiliary sliding sheet to treat pressure injuries. (A) A pressure injury of the sacrum that was classified by the Design-R scoring system as d2 (the area extending to the dermis) was produced. (B) The partial auxiliary sliding sheet was used for 5 days. (C) A new d2 pressure injury was created at a similar location in the sacrum. (D) The external auxiliary sliding sheet was re-attached to the wound site through the dressing for 7 days; then the epithelialization was completed.
The management of friction, shear, pressure and their combined effects is very important for the successful prevention and treatment of pressure injuries. 1 The clinical effectiveness of preventive dressings in preventing pressure injuries has been recognized; however, there is little information about the use of mechanical force-reducing materials during the treatment of pressure injuries. The study revealed the effectiveness of TASS in reducing friction, shear forces and their combined effects, indicating that TASS can be a new and valuable solution for local treatment of pressure injuries.
The most important finding of this study is that compared with groups A and B, the internal shear force of group C was significantly reduced (p <0.05; Figure 5), which may be due to the reduction of the static and dynamic friction coefficients of the interface ( image 3). In contrast, due to the higher coefficient of friction, the A and B groups exhibited higher shear stress during the pulling of the skin model. These findings indicate that the use of TASS can help reduce internal shear stress in the ulcer site caused by patient exercise.
Figure 7 illustrates the effect of TASS on reducing friction and shear. The actual force loaded on the skin model comes from the combination of the x-axis and z-axis forces, and is finally imaged as a vector. The results obtained from this study indicate that under dynamic conditions, there are differences in the force direction between group A and group B, and group C, and the magnitude of the force between groups may be similar. Due to the powerful shear reduction effect of TASS, it is speculated that the z-axis force in group C is greater under dynamic conditions. A smaller shearing force has less influence on the shape change of the skin model during movement, so the force detected by the sensor in the z-axis direction may remain high. This finding may mean that the use of TASS to treat pressure injuries mainly caused by shear forces is preferable to pressure injuries caused by minimal shear forces. Figure 7 illustrates the effect of each test group on friction and shear based on the results of the simulated skin shear test. (A) Under static conditions (without pulling the skin model), only static pressure is applied to all test groups. (B and C) Load a combination of shear and pressure under dynamic conditions (pull the skin model). It shows the difference of the composite vector direction between group A and group B and group C.
Figure 7 illustrates the effect of each test group on friction and shear based on the results of the simulated skin shear test. (A) Under static conditions (without pulling the skin model), only static pressure is applied to all test groups. (B and C) Load a combination of shear and pressure under dynamic conditions (pull the skin model). It shows the difference of the composite vector direction between group A and group B and group C.
It should be noted that TASS itself cannot reduce the pressure during the pulling process of the skin model (Figure 4). Therefore, in a real-world clinical environment, the combination of TASS and decompression support surfaces (ie, high-tech mattresses and cushions) will better reduce internal shear and pressure. It is expected that the combined use of TASS and any supporting surface will not only help change the direction of the force, but also help reduce the magnitude of the force in the simulated skin shear test. Further experiments are needed to clarify which types of decompression support surfaces and TASS are more suitable for pressure injury treatment.
The generation of shear force affects the expansion of blood vessels, thereby reducing blood flow and leading to the production of avascular necrotic tissue that can delay wound healing. 27,28 Previous research has shown that when it occurs at the same time, the level of pressure sufficient to block blood flow decreases. Shear force was applied, 29-31 showed that shear force can reduce the pressure required to produce soft tissue rupture. As an example of the actual situation, it is well known that when the head of the bed is used, repeated shearing forces and pressures will be generated between the patient's body and the contact object. 11 In order to protect the pressure injury and allow sliding of TASS and other materials that reduce shear force on its surface, it is expected that it will bring more benefits to protect patients from secondary infection, pain and discomfort of the wound site and the surrounding skin.
It is important to understand that repeated friction and synthetic shear forces can cause skin tissue damage associated with the development of pressure damage. It has been reported that the shear force of the heel of the elderly is reduced by using a low-friction outer dressing. 32 Although there is a certain relationship between interfacial friction and internal shear, it is not clear how different levels of friction can cause skin damage to accumulate. The author believes that if the effect of skin tissue damage on different repeated friction levels is tested in another study, this clinical problem can be solved.
Since TASS is multifunctional, it is expected that its application will extend to various clinical settings, from acute care to home care. As a first step, the author focuses on the treatment of stress injuries in the home care environment, because the problem of stress injuries is very serious in the elderly at home or in the community, and more serious than patients in emergency hospitals. 33 In addition, in the clinical situation of home care, the value of TASS features can be maximized. In this study, a protocol on how to clinically use TASS to treat stress injuries in home care was proposed. In the future, clinical studies involving more participants are needed to clarify the clinical safety and effectiveness of TASS. The authors speculate that due to the powerful internal shear reduction effect of TASS, severe (eg, stages 3 and 4) pressure injuries and intracavitary wounds are considered the most suitable for this treatment.
Another clinical point of view, namely the timing of TASS intervention, is important for pressure injury management. When the presence of necrotic tissue or biofilm is identified as an important risk factor for delayed wound healing, doctors occasionally choose surgical procedures, such as debridement. 34,35 The doctor (YN) in this study suggested that TASS should be started immediately after completing the surgery. Continuous use of TASS at the wound site may effectively increase cell proliferation, tissue granulation and re-epithelialization, leading to complete wound healing without further delay.
Our testing philosophy includes the use of bionic testing methods instead of standard testing methods to simulate the actual clinical environment. Previous reports on the preparation and evaluation of skin models for biomechanical applications based on synthetic polymer materials have been published. 36-39 Among the available materials, a soft polyurethane substrate was used in this study to simulate the physical properties of human skin. The friction coefficient and elastic modulus of the skin model are set to be similar to the friction coefficient and elastic modulus of the elderly skin, and the elderly are often at risk of pressure injury. When investigating ulcer management, it is also important to consider the impact of bone protrusion. However, in order to simplify the skin model used to evaluate interface friction and internal shear force and pressure, we did not consider bone protrusion in this study. In future studies, we will be able to use the skin model prepared in this study to study the reduction of mechanical stress at the bone protrusion.
It is well known that external pressure exceeding 32 mmHg can cause vascular occlusion, and the occlusion for a long time can cause tissue necrosis, which then develops into a pressure injury. 40 In fact, the compressive stress at the pressure injury site has been in the range of 18 to 186 mmHg, depending on the patient's physical characteristics and mattress selection. 41 Therefore, applying a compressive stress of 100 mmHg in the simulated skin shear test is considered a bionic test method. In addition, the author speculates that the strain field in the skin model used in this study is equivalent compared with the strain field in the patient’s tissue, because a skin model that mimics the mechanical properties of human skin is used in the simulated skin shear test.
We believe that this research is the first step in a new method to reduce the friction and shear forces of the skin and wound sites to treat pressure injuries. It is necessary to further study the use of skin models to study the mechanical force reduction effect of TASS on the bone protrusion, verify the combined effect of TASS and pressure redistribution support surface to reduce mechanical force, and conduct a larger sample size clinical trial to verify the effectiveness of TASS.
TASS uses a skin model to significantly reduce interface friction and internal shear forces. From the case study, TASS may be used as an adjunctive dressing for the treatment of stress injury in home care.
PTFE, PTFE; TASS, auxiliary sliding sheet for external use.
The data set used in this study can be obtained from the corresponding author upon reasonable request.
This study was approved by the Institutional Review Board of Nara Tenri Hospital in Japan (No. 1069). Written informed consent was obtained from the participants. The patient or the legal representative of the patient provided informed consent for the detailed case information and accompanying images to be released. All aspects of this research are in line with the principles set out in the Declaration of Helsinki.
The author thanks Yinglunge for providing English editing services. This experimental research was funded by ALCARE.
All authors are heavily involved in conception, research design, data collection and data analysis. All authors also participated in the drafting of the manuscript and key revisions of important intellectual content, and finally approved the version to be published. Finally, all authors agree to be responsible for all aspects of this work to ensure that issues related to the accuracy or completeness of any part of this work are properly investigated and resolved.
MK is an employee of ALCARE Co., Ltd (Tokyo, Japan). YN is the head of the Family Health Care Stress Injury Research Center (Nara, Japan). The author has no other conflicts of interest related to this work to disclose.
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