FormalPara Key Summary Points

Why carry out this study?

Many patients with chronic conditions such as rheumatoid arthritis and psoriatic arthritis have limited mobility and dexterity in their hands and need acceptable devices for self-administration of biologics.

This study collected feedback from health care professionals (HCPs) on the usability, functionality, and acceptance of the SmartClic®/ClicWise® device and its associated mobile application.

What was learned from this study?

Favorable responses were received from HCPs on the ease of use, feature design, effectiveness, and injection speed of the SmartClic/ClicWise device and functionality of the mobile application.

The SmartClic/ClicWise device is an acceptable alternative for self-administration of biologics for the treatment of rheumatoid arthritis and other conditions. Further study is needed in patients who will be using the device to confirm the findings.

Digital Features

This article is published with digital features, including a plain language summary, to facilitate understanding of the article. To view digital features for this article go to https://doi.org/10.6084/m9.figshare.21816207.

Introduction

Inadequate adherence to treatment in patients with chronic diseases such as rheumatoid arthritis (RA) can have a critical impact on treatment effectiveness and utilization of healthcare resources [1, 2]. Adherence may be enhanced by patients’ ability to self-administer medication, which allows them greater freedom, control, and independence in many aspects of their lives [3,4,5]. Self-administration of biologic therapy in patients with RA has also been associated with improved clinical, functional, and quality-of-life outcomes [6]. However, self-injection may be particularly challenging for patients with rheumatic diseases such as RA because they frequently experience mobility and dexterity problems [7,8,9,10,11,12]. Psychological barriers to self-injection may also lessen gains in adherence associated with self-administration of treatment. Fear of injection and injection pain are very common in individuals with type 1 diabetes and can result in skipped insulin injections and adverse treatment outcomes [13,14,15,16,17,18,19]. Very high pain catastrophizing scores have been reported in one-quarter of patients with RA or spondyloarthritis treated with biologics, which could jeopardize adherence with self-administration and treatment response [20].

To improve patients’ adherence to and experience with treatment, several devices have been developed for the self-administration of biologics by subcutaneous injection, including the single-dose vial with syringe, prefilled syringes, prefilled pen injectors/autoinjectors, and electromechanical injection devices (e.g., ava Connect®, AutoTouch®) [21,22,23]. In patients with RA, autoinjectors have been preferred over prefilled syringes due to ease of use, portability, and convenience, particularly in patients with impaired manual dexterity [4, 24, 25]. Other important features of these devices in rheumatic diseases include manageable size and weight, and convenient shape [26].

Although single-use, disposable, spring-loaded autoinjectors improved the ease of self-administration of medications, research has shown that challenges remained for patients using these devices [27,28,29], leading to exploration of potential alternatives that would improve the injection experience and adherence. Recently, electromechanical injection devices have been developed that are reusable and offer enhanced technical features compared with the previous generation of prefilled pen injectors/autoinjectors [21].

A new electromechanical presentation for subcutaneously administered biologics, the SmartClic®/ClicWise® autoinjector (manufactured by PHC Corporation, Toon City, Japan), has recently been developed for use primarily by patients, but also by caregivers and health care professionals (HCPs) (Fig. S1). This reusable, multi-use, single-patient injection device includes a prominent graphical user interface display with text, animated action illustrations, arrows, and visual confirmation feedback designed to simplify and inform the autoinjection experience. The device is used with disposable dose dispenser cartridges (DDCs) that are loaded into the device with each new dose. In addition, an optional mobile application (app) is proposed for use with the device that will allow patients to track their injection schedule, record symptoms, and export data to smartphones and computers. The aim of the present study was to examine the impressions and opinions of HCPs who evaluated the ease of use, feature design, effectiveness, and injection speed of the SmartClic/ClicWise device, as well as the functionality of the device’s proposed mobile app.

Methods

Study Participants

Licensed HCPs (registered nurses, licensed practical nurses, licensed vocational nurses, certified nursing assistants, medical doctors, doctors of osteopathic medicine, and physician assistants) were eligible to participate in the study if they were ≥ 18 years of age, cared for patients with rheumatologic/rheumatic conditions, and were experienced at administering injections. All HCPs who participated in this study also participated in a ‘Sharps Injury Prevention Study’ for the SmartClic/ClicWise autoinjection device that was conducted immediately beforehand (and required for regulatory submission of the device). The HCPs were blinded to the sponsor of the study as well as the medicines intended to be used with the device.

Study Design

This study and the aforementioned Sharps Injury Prevention (SIP) Study were conducted by Design Science at the Schlesinger Group market research facility in Munich, Germany, from September 28 to October 8, 2020. Prior to their enrollment in the Sharps Injury Prevention Study, HCPs were screened via telephone interview to determine whether they satisfied eligibility criteria. During that 30-min study, eligible participants watched a 5-min visual demonstration of how to properly use the SmartClic/ClicWise device and DDCs and subsequently performed 20 simulated injections into injection pads using DDCs filled with water during a 25-min hands-on test period.

Following the SIP study injection simulations, as part of the current study, participants answered general background questions from the moderator and completed a two-part, paper-based questionnaire. The first section of the questionnaire included questions on the HCPs’ experience in treating rheumatology patients and using injection devices; the second section included questions on various aspects of the SmartClic/ClicWise device. The moderator subsequently presented the proposed app (in development) to the HCPs using a storyboard and asked questions regarding how the participant perceived its planned functionality.

Participant responses were recorded as multiple-choice selections, Likert scale ratings, or open-ended comments as appropriate. The Likert scale is a psychometric scale that uses scaling responses [30]. This study used a seven-point scale for participants to express how much they agreed or disagreed with a particular statement. Participants were asked to provide scores on the following topics: (1) ease of use of the device (28 questions): scale from 1 (strongly disagree) to 7 (strongly agree); (2) features of the device (six questions): scale from 1 (not beneficial) to 7 (extremely beneficial); (3) effectiveness of the device (two questions): scale from 1 (not effective at all) to 7 (extremely effective); (4) injection speed of the device (four questions): scale from 1 (strongly disagree) to 7 (strongly agree); (5) training time: multiple-choice question; and (6) functionality of the app (12 questions): scale from 1 (strongly disagree) to 7 (strongly agree).

Research instrument design, participant recruitment, compensation, consent, data handling, data privacy and volunteers’ statements were handled following Design Science’s human factors standard operating procedures. Participants consented to participate in testing the device and having their data analyzed. All participants have received compensation for their participation within 'fair market value' rules.

Data Analysis

All data were anonymized, and each participating HCP was assigned a unique identification number that was stored in a secure, password-protected file accessible only by Design Science Group. Participant responses that involved a Likert scale were reported as mean, median, and mode scores.

Results

Study Participants

A total of 25 HCPs participated in the study, 22 (88%) of whom were female and 19 (76%) of whom were registered nurses (Tables 1, 2). The most common specialties reported were intensive care, emergency room, orthopedics, and surgery; the most common rheumatologic condition of patients cared for by the participants was RA. Five HCPs (20%) treated rheumatology patients at least weekly (daily: n = 1 [4%]; every few days: n = 2 [8%]; weekly: n = 2 [8%]), and 20 (80%) did not treat rheumatology patients frequently (rarely: n = 12 [48%]; every couple of weeks: n = 7 [28%]; monthly: n = 1 [4%]). All 25 (100%) of the HCPs reported having experience with administering injections, although only five (20%) reported experience with injecting biologics (< 10% of injections: n = 4; ~ 25% of injections: n = 1) (Table 2).

Table 1 Characteristics of the participating HCPs
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Table 2 Characteristics of health care professionals related to clinical practice
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HCP Feedback on the SmartClic/ClicWise Device

HCP feedback on the ease of use, feature design, effectiveness, and injection speed of the SmartClic/ClicWise device was positive, with mean scores > 4.50 for all questions (Figs. 1, 2). Of note, the device received very favorable scores for being easy to learn how to use, being safe to handle, and having effective audio and visual feedback during and after the injection. Mean scores < 5.00 were only reported on two of the 40 questions. Table S1 includes all mean, median, and mode scores for the HCP feedback on the SmartClic/ClicWise device.

Fig. 1
figure 1

HCPs’ evaluation of the ease of use of the SmartClic/ClicWise device. Mean Likert scale ratings for each feature of the SmartClic/ClicWise device ranged from 1 (strongly disagree) to 7 (strongly agree). aResponses to this question have been inverted because the question was negatively worded

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Fig. 2
figure 2

HCPs’ evaluation of the features and effectiveness of the SmartClic/ClicWise device. Mean Likert scale ratings for each feature of the SmartClic/ClicWise device ranged from 1 (strongly disagree) to 7 (strongly agree)

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Twenty-four (96%) of the HCPs considered a training time of ≤ 20 min to be sufficient to train patients on how to effectively use the injection device (Fig. 3). All 25 (100%) of the HCPs thought that training would be required, and none thought it would require > 30 min. Open-ended comments regarding the device and its features were provided by 21 (84%) of the HCPs, with 11 (44%) commenting that they felt the device was intuitive, safe, and easy to use, and 10 (40%) commenting that the device was large or heavy.

Fig. 3
figure 3

HCPs’ estimates of the training time required to use the SmartClic/ClicWise device

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HCP Feedback on the Optional App

HCP feedback on the companion app, presented via storyboard, was positive, with mean scores > 5.70 for all questions (Fig. 4). The highest mean scores for the evaluation of the functionality of the app were for its injection reminder function and the record for the injection site used. The mean, median, and mode scores for the HCP feedback on the app are included in Table S1.

Fig. 4
figure 4

HCPs’ evaluation of the potential functionality of the mobile app associated with the SmartClic/ClicWise device. Mean Likert scale ratings for each feature of the SmartClic/ClicWise device ranged from 1 (strongly disagree) to 7 (strongly agree). HCPs evaluated the companion app after its presentation via storyboard (rather than live demonstration). aOverall pain and number of tender joints

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Open-ended comments regarding the app were provided by 11 of the HCPs. Comments included that older patients may not use smartphones or apps (n = 5), the app would be useful (n = 4), and the app should be made as simple as possible to aid patient compliance (n = 2).

Discussion

The results from this study involving 25 HCPs showed positive feedback on the ease of use, feature design, effectiveness, and injection speed of the SmartClic/ClicWise device and planned functionality of its associated optional app. Mean scores on the seven-point Likert scale employed in this study were > 4.5 for all 52 questions on the device and companion app. The combined mean scores for the three categories of questions were 6.0 for ease of use of the device, 6.3 for features and effectiveness of the device, and 6.1 for functionality of the app. Overall, the scores obtained indicate that the HCPs gave strongly positive feedback on the SmartClic/ClicWise device and companion app. HCP feedback also indicated a high likelihood that they would recommend the device and app to their patients and colleagues.

Some inconsistencies were observed between the mean Likert scale scores and the comments provided by the participants. For example, ten HCPs commented that the device was large or heavy for patients, but the mean scores for size (5.28), weight (5.68), comfortable to hold/does not slip (5.60), and easy to grip (5.56) do not reflect these comments. One possible explanation is that most participants performed injections in acute settings using disposable devices. HCPs were responding using the Likert scale based on their evaluation compared with such devices, while the comments were indicating their thoughts on how the device can be improved and their preferences.

HCP mean Likert scale scores on the companion app were also high (> 5.70), but several HCPs questioned the suitability of the app for use by older patients who may not own a smartphone. Well-designed mobile health apps can be an effective tool for empowering patients with chronic conditions to self-manage their health [31,32,33]. On the other hand, in a 2019 cross-sectional survey of primary care patients seen in a publicly funded clinic in the United States, Kumar et al. reported that only 45% of participants ≥ 50 years of age owned a smartphone [34]. Furthermore, older participants were less likely than younger participants to use their phones for online browsing, social media, or apps. However, it should be noted that the companion mobile app for the SmartClic/ClicWise device is an optional feature, i.e., app use is not required with the device.

A strength of this study is the use of a Likert scale, which allows for the collection of quantitative data representing degrees of opinion rather than binary ‘yes or no’ answers. The study also has some limitations. The sample size of HCPs (n = 25) participating in the study was relatively small, and although all participants were very experienced and knowledgeable about administering injections, they may not have been very familiar with the specific challenges faced by patients with rheumatic disease or with the administration of biologics. In addition, the study was a non-comparator study that did not explore HCP opinions relative to different autoinjector devices. However, participants were selected based on their experience with injection administration and were expected to consider this experience while evaluating the SmartClic/ClicWise device. The omission of ‘15 min’ as a response option for the multiple-choice question about the estimated training time required was another limitation, and HCPs’ estimates of patient training time may have been biased by their own experience and intuition. Finally, the mobile app was presented to participants via storyboard (rather than live demonstration), as the app was not fully developed at the time the study was conducted.

All of the HCPs’ scores for the device and app were included in the data analysis. Although most scores were favorable for the device, some individual scores appeared near the lower end of the Likert scale. For example, most HCPs strongly agreed that keeping the needle concealed throughout the injection process was an effective device feature (score: ‘7’). However, one participant (a cardiosurgical intensive care nurse) strongly disliked this feature (score: ‘1’), indicating that she preferred to see the needle when administering an injection.

Conclusions

In conclusion, HCPs reported a high level of usability, functionality, and acceptance of the SmartClic/ClicWise device and the companion app. Further studies are warranted to assess patients’ opinions, and one large patient study is currently underway. However, initial HCP perceptions suggest that the novel SmartClic/ClicWise autoinjector will provide patients with an acceptable alternative for self-administration of therapeutics for the management of RA and other conditions.