Introduction

An orthosis is defined as “an externally applied device used to modify the structural and functional characteristics of the neuromuscular and skeletal systems” [1]. The terms orthosis and splint are often used synonymously in the healthcare field. However, orthosis is a more inclusive term compared to splint, in that it provides a force system for dynamic control in addition to stabilization of the body [2]. In addition, orthosis is a permanent device to substitute for the loss of muscle function, whereas a splint is commonly prescribed for temporary use as part of a treatment program [3]. There are several types of orthoses, and they can be classified according to anatomic site, material, purpose of application, or power source.

Orthoses can be used for patients with neuromuscular and musculoskeletal impairments that result in functional limitation and disability. Overall 35 million Americans have disabling conditions that interfere with their life activities, and 16% of those have an orthopedic impairment. Approximately 20% of individuals with complete or partial paralysis of the extremities use orthoses. Of those with paralysis, 27% are 45–64 years of age. The proportion of the population with some paralysis will increase significantly as the Baby Boomer generation ages [reaching ages 46–64 after 2010] [4]. The total number of people with paralysis, deformities, or orthopedic impairments who use orthoses is expected to reach 7.3 million by 2020 [5]. In Taiwan, the number of people with physical and mental disabilities reached 1.11 million in 2012. Many of these individuals need orthoses to help them cope with limitations that interfere with their ability to complete the activities of daily living. In 2005, the Ministry of the Interior enacted the Act entitled “Regulations on Subsidization for Medical Treatment and Auxiliary Appliances for the Disabled” pursuant to the law entitled “Physically and Mentally Disabled Citizens Protection Act.” These regulations provide subsidization for medical rehabilitation that is not covered by the national health insurance and for auxiliary appliances used to help the disabled to get over the physiological malfunction and promote their self-servicing abilities. These regulations covered orthoses as rehabilitation devices. They included lower limb orthoses, upper limb orthoses, spinal braces, pressure garments, and others. The effectiveness of devices and user satisfaction are important indicators that help the government or policy makers make decisions.

Furthermore, user satisfaction is considered an important outcome measurement in evidence-based healthcare and the client-centered approach [6]–[8]. DeRuyter [9] asserted that the five main outcomes in the field of assistive technology are user satisfaction, clinical results, functional status, quality of life, and costs. User satisfaction can be defined as an attitude about a service, a product, a service provider, or a person's health status [6]. The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) was designed as an outcome measurement instrument to measure user satisfaction with a wide range of assistive technology. This 12-item measure assesses user satisfaction with two components, i.e., Device and Services [10], with items measured on a 5-point satisfaction scale, which has proved to be a reliable and valid instrument for measuring outcomes in the field of assistive technology [11]. The original Canadian English and French versions of QUEST 2.0 were translated into Dutch, Swedish, Norwegian, Danish, Japanese, and Cantonese [12]–[15]. Mao et al. [16] developed and validated the Taiwanese version of QUEST 2.0 (T-QUEST). They identified culture-specific items and added them to QUEST 2.0. The item ‘Cost’, identified as the expense associated with purchasing, maintaining, and repairing the device, was the only culture-specific item incorporated into the service component of T-QUEST. Therefore, T-QUEST includes 13 items, i.e., eight items in the device domain and five items in the service domain. The results of Mao et al.'s research indicated that T-QUEST is a valid and reliable instrument for measuring user satisfaction with various types of assistive technology among Mandarin-speaking individuals in Taiwan.

Several studies have examined user satisfaction with orthoses. One study conducted by Greetzen et al. [17] assessed consumer/patient satisfaction with the services of the prosthetics and orthotics facilities in the northern part of The Netherlands. Other studies examined the users' satisfaction with or opinions about specific orthoses. Those studies included parental satisfaction with the CranioCap [18], consumer opinions of a stance-control knee orthosis, and a hinged ankle-foot orthosis [19,20]. They also included patient satisfaction with lower limb orthoses and custom-molded foot orthoses [21,22]. Some of the studies addressed user satisfaction with hand orthoses for radial nerve injury and rheumatoid arthritis [23,24] and a spinal brace for scoliosis [25]. Few studies have been conducted to investigate user satisfaction with orthoses in Taiwan. The research data were scarce since most of the research related to user satisfaction focused on daily living assistive devices but not the orthotic devices and the research evidence were based on anecdotal evidence from personal interview or online surveys. Therefore, the purpose of this study was to investigate the user satisfaction with orthotic devices and service using the T-QUEST. The orthotic devices included lower limb orthoses, spinal braces, and pressure garments. These devices are auxiliary appliances that are funded through the government welfare allowance, and they are prescribed commonly for non-temporary problems of persons with disabilities. In contrast to the lower-limb orthoses that address walking and running issues, the upper limb orthoses are involved in a greater variety of activities. The types of upper limb orthoses vary because of the complexity of the functions provided by the hands and upper limbs. In addition, very few disabled people use upper limb orthoses that are covered in the benefits regulations. Therefore, user satisfaction with upper limb orthoses was not investigated in this study.

In summary, user satisfaction is an important outcome in evidence-based and client-centered practice. In addition, different subsidy policies or regulations in different countries may influence user satisfaction. Therefore, the purpose of this survey was to describe user satisfaction with orthosis and service offered to subjects with disability who are receiving orthosis and service subsidized by the government in Taiwan. Further objectives were to determine whether demographic (age, gender, area, education level) and clinical (severity, type of orthosis, duration of usage) characteristics influence satisfaction. By investigating users' satisfaction and collecting users' opinions, we hope to influence the policy makers to establish policy and funding regulations.

Methods

Results

Participants' characteristics

Two hundred and eighty valid questionnaires completed by participants (160 males and 120 females) were included in the analysis. The mean age of participants was 44.7 (SD = 13.0, range 8–90) and 57.1% were males. Most of the participants were polio survivors (47.1%). Various diagnoses, such as lumbar spondylosis, scoliosis, and sciatica were included in the miscellaneous group. Eighty-two percent of the participants wore their orthoses every day. Regardless of whether the participants obtained their orthoses from the assistive technology or orthotics centers, almost all participants received orthotic services, such as prescription, assessment, measurement, or fitting of orthosis during application. The demographic and clinical characteristics of the participants were presented in Table 1.

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Table 1. Demographic and clinical characteristics of the participants.

https://doi.org/10.1371/journal.pone.0110661.t001

User satisfaction

Table 2 shows the ratings of the participants on all 13 items divided into the two domains. Overall, the most participants indicated that they were satisfied with their devices and service. The percentages of participants who indicated ‘quite satisfied’ (4 on the scale of 1 to 5) or ‘very satisfied’ (5 on the scale of 1 to 5) were combined to determine a percentage of individuals who are satisfied. There were 69.1%, 59.6%, and 65.3% of participants satisfied with their device, service, and total respectively. Only a few participants were not satisfied at all with device (1.6%), service (2.8%), and total (2.0%).

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Table 2. Number and percentage of participants who rating the T-QUEST.

https://doi.org/10.1371/journal.pone.0110661.t002

Table 3 shows the means and standard deviations of satisfaction scores for each of the items of T-QUEST for each orthosis separately and for all orthoses combined. User satisfaction with the orthotic device and with the service was medium to high. Mean scores for users' satisfaction were 3.74 (SD = 0.64) for their devices, 3.56 (SD = 0.76) for service, and 3.67 (SD = 0.64) for total. The mean scores for each item ranged from 3.10 (‘Cost’) to 3.94 (‘Safety’). The participants were satisfied most with ‘Safety’, followed by ‘Professional service’ and ‘Effectiveness.’ They expressed the least satisfaction with ‘Cost’, followed by ‘Comfort’ and ‘Follow-up.’ For different types of orthoses, the highest mean total score was 4.30 (SD = 0.57) for pressure garments, and the lowest mean total score was 3.40 (SD = 0.66) for knee-ankle-orthoses. The scores of the items rated by the participants with pressure garments were all above 4, except the ‘Comfort’ item.

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Table 3. Means (SD) of satisfaction scores of T-QUEST for each orthosis and for all orthoses.

https://doi.org/10.1371/journal.pone.0110661.t003

The results indicated a significant difference between the mean subscores of T-QUEST for all six types of orthotic devices and for service (p = 0.001). The mean service subscore was lower compared to the device subscore. The three items of T-QUEST that were ranked as the most important were ‘Comfort’ (53.2%), ‘Safety’ (42.9%), and ‘Cost’ (32.1%). The three least important items identified by the users were ‘Service delivery’ (5.4%), ‘Adjustment’ (7.9%), and ‘Follow-up’ (8.6%).

Reasons for being dissatisfied

In contrast to previous studies that examined users' satisfaction with one specific orthosis, this study investigated users' satisfaction with six types of orthoses. Since all these orthoses were funded through the government welfare allowance, this study was commissioned by a government program for investigating the user satisfaction under the subsidy scheme. Furthermore, by including six types of orthoses it was possible to compare the user satisfaction with different types of orthoses. It was speculated that the reasons for dissatisfaction stated in each item might concern one specific type of orthosis. However, the reasons for dissatisfaction were applicable to all types of orthoses after the data was reviewed with scrutiny. For each item, participants who assigned score of less than 4 to different types of orthoses gave the same reasons for dissatisfaction. The percentages of participants who indicated dissatisfied (score of less than 4) and provided comments for each item in each orthosis were shown in Table 4.

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Table 4. The percentages of participants who indicated dissatisfied and provided comments for each item in each orthosis.

https://doi.org/10.1371/journal.pone.0110661.t004

The most common reasons that the users were not quite satisfied or very satisfied included the following: 1) Dimension: Most participants (n = 32) commented that the orthoses did not fit properly and were either too large or too small; 2) Weight: Most participants (n = 65) commented that the orthoses were too heavy; 3) Adjustment: Fewer number of participants (n = 24) commented about the problems related to adjustment of the orthoses; 4) Safety: Numerous participants (n = 28) commented on safety issue. Some of the comments stated that the orthoses were lacking security and stability because the screws were too loose or the soles of the shoes were very slippery, 5) Durability: Most participants (n = 50) commented about the poor durability of the accessories of the orthoses, such as padded foam, velcro, insoles, or leather, 6) Ease of use: Some participants (n = 45) expressed problems with the use of the orthoses. They commented that it was difficult for them to put the orthoses on or take off, 7) Comfort: Most participants (n = 65) stated that they were uncomfortable when wearing the orthoses for a long period because they felt hot and the orthoses had poor air permeability, 8) Effectiveness: Some respondents (n = 22) stated that their problems had not been resolved or the effects of orthoses were different from what had been expected; 9) Service delivery: Most participants (n = 48) complained about the service processes or procedures, stating that they were long and complicated, 10) Repairs and services: Some participants (n = 28) commented on this issue, including that the warranty period was too short, there were no maintenance services, the repairs were time-consuming, there were no in-house services, and service attitudes were poor, 11) Professional services: Participants (n = 21) also commented about professional services. The participants expressed that the quality of professional services was not high enough, as no professional assessment was provided, the professionals were not full participation and lack of proper information (e.g., wearing methods, maintenance) provided, 12) Follow-up: Most of the participants (n = 64) stated that there were no follow-up services, 13) Cost: All participants (n = 110) commented that the cost of the orthoses was too high.

Discussion

In this study, we examined users' satisfaction with orthotic devices and service using T-QUEST. Although various versions of QUEST were not explicitly designed to measure user satisfaction with orthoses, and they may not embrace all important aspects of satisfaction specific to orthotic users [26], T-QUEST was the only culture-specific measurement of user satisfaction that possessed good psychometric properties when used with Taiwanese people [16]. Moreover, the participants were asked to provide additional comments and suggestions revealing the important aspects of their orthoses (e.g., cosmetic appearance of device) in addition to those revealed in the measurement.

The results showed that about two-thirds of the participants were quite satisfied or very satisfied with their devices and service. The mean satisfaction score was 3.74 for the devices and 3.56 for service, and these values were lower compared to those obtained from satisfaction surveys conducted in western countries, where the average satisfaction scores were 4 or more [27,28]. However, the satisfaction scores were similar to those obtained from the other studies using T-QUEST or the Chinese version of QUEST (C-QUEST). Since most Chinese people express their opinions conservatively, they would choose the middle (near score 3) rather than the extreme answers [12,16]. Certainly, there is still room for improvement in orthotic devices and service in Taiwan. Specifically, more effort should be put on improving orthotic service since the satisfaction with services was lower than satisfaction with the orthotic devices.

The item ‘Safety’ was rated high on both importance and satisfaction; thus, this strength should be highlighted. In contrast, the item ‘Follow-up’ was rated low on importance and low on satisfaction. Although ‘Follow-up’ was not rated as a very important item, it still worthy to invest efforts to improve follow-up service. The two items ‘Comfort’ and ‘Cost’ were both rated high on importance and low on satisfaction. This means that there was a large gap between the perceived level of importance and the perceived level of satisfaction and that these areas deserve immediate attention. The items that were identified as low on satisfaction and high on importance should be given the highest priority.

The costs of the appliances were not fully covered by the welfare allowance; the government reimbursed only a portion of the expense. The orthotic users must pay the remaining, non-reimbursed portion. Aside from the non-reimbursed expenses, the users must also pay the maintenance and repair fees for their orthoses. Furthermore, a considerable number of the participants (45%) were unemployed or low-income employees. Therefore, ‘Cost’ was a major concern for the users of the orthoses. Most participants also suggested increasing the maximum subsidy for the devices and service. Another low satisfaction item, ‘Comfort,’ was also the only item that received a score of less than 4 for the pressure-garment users. A previous study showed that discomfort appeared to promote low compliance with pressure garment use [29], and satisfaction with comfort appeared to be an important factor for device usage [30]. Therefore, the orthotist or therapist must assess whether the orthosis causes the user any discomfort or pain when prescribing an orthosis.

‘Cost’, ‘Comfort’, ‘Control’, and ‘Cosmesis’ are called the four C's, and they are four most important concepts that should be considered when defining an “ideal” orthosis for a patient [31]. The term ‘Control’ means controlling function and achieving the desired goal, which is equivalent to ‘Effectiveness’ in our measurement. ‘Cosmesis’ was not included in T-QUEST, but some participants suggested that cosmetic appearance of orthoses should be considered. Previous studies have also demonstrated that persons often want their orthoses to be cosmetically appealing, convenient to use with their usual clothing, and not too noticeable [32,33].

Our results revealed no significant gender, age, and educational level differences in satisfaction scores. The results were consistent with the findings of Geertzen's study in which it was demonstrated that consumer satisfaction with prosthetic and orthotic facilities did not differ by age and gender [17]. However, the results of Hall and Dornan's study showed that older and less educated patients were more satisfied with their medical care, while gender did not correlate with satisfaction [34]. Inconsistent results in the literature indicated that sociodemographic characteristics were only minor predictors of satisfaction [6]. Exceptionally, the participants from eastern area and offshore islands were the least satisfied with the orthotic service. In Taiwan, the eastern area and offshore islands are considered remote areas. The resources for providing orthotic service in remote areas are less than in urban area. Therefore, the government has a responsibility for improving access to orthotic service in eastern area and offshore ilands in Taiwan.

In our study, the participants with mild disability were most satisfied with the device and service. The possible reason is that the participants with mild disability were likely to have less impairment, and it appears that it is easier to reduce mild disability caused by impairment rather than moderate or severe disability. Hall and colleagues reviewed the literature and found that patients with better health status tend to be more satisfied with their medical care, but their study did not confirm the causal factors in this relationship [35]. The pressure-garment users also obtained the highest satisfaction score. They rated all items except for ‘Comfort’, a score of 4 or more. Perhaps some items of T-QUEST were less relevant to pressure garments, such as weight, adjustments, and safety, leading to fewer problems in those items. Previous study also demonstrated that the factors that affect burn patients' satisfaction with pressure therapy included fees, knowledge, effectiveness, mobility, and comfort [36]. Some factors (e.g., knowledge, mobility) presented in that study were different from the satisfaction items in T-QUEST. The participants who used their orthoses for less than one year had the greatest satisfaction scores. This finding could be possibly attributed to the new users were more easily to perceive the effectiveness of the device when compaired to no orthosis and the problems in some items (e.g., durability and repair) were less likely to occure in a short period of time. On the contrary, the longer the duration of usage, the problemns were likely to occure.

Some participants expected the service provider to provide orthotic evaluation and training by an appropriately trained professional and allow them to access complete and current information concerning the orthoses. The Ministry of Health and Welfare in Taiwan established the Center for Assistive Technology Resources and Popularization to integrate resources and promote service of assistive technology. In addition, a website (Resource Portal of Assistive Technology) was created to provide information about subsidies and welfare, legislation and regulations, product specifications and vendors, and assistive technology service. The website enables service users to obtain updated and versatile information, and receive suitable services effectively [37].

The reasons for being dissatisfied as well as the opinions and suggestions proposed by the participants may direct orthotic manufacturers and professionals to fabricate state-of-the-art orthoses and deliver high-quality service and guide the government in their policy decisions. The satisfaction of users measured by T-QUEST provided additional culture-specific information concerning the cost. Most users felt that the orthosis was too expensive and hoped that the maximal subsidy funding could be increased. Moreover, the participants living in the eastern area and offshore islands were the least satisfied with orthotic service. These results may give a reference to related studies conducted in different countries with similar economic situation and subsidy policies.

One limitation of the current study was that the small, non-probability convenience sample may limit the generalizability of this study. Another limitation was that we did not ask participants how many hours per day they wore their orthoses, since most participants wore their orthoses every day. The wearing time per day may affect the satisfaction.

Conclusion

In conclusion, this study demonstrated that the overall user satisfaction with orthotic devices and service were median high. About two-thirds of users were quite satisfied or very satisfied with their orthotic devices and service. The participants with mild disability, wearing the pressure garment and using the orthosis for less than one year, were the most satisfied. There is a need for improved orthotic devices and service, especially for improved comfort and subsidy funding. The satisfaction of orthoses users can be improved by using advanced materials that would increase permeability and comfort, ensuring availability and accessibility of service, increasing the maximum subsidy for orthoses, and the like. The results of this study and the suggestions made by the participants provide useful information for clinicians to better understand the needs of the users of orthoses and for policymakers to consider in future policy making.

Acknowledgments

The authors acknowledge the valuable contributions of all of the study participants.