Development and field testing of a decision aid to facilitate shared decision making for adults newly diagnosed with attention‐deficit hyperactivity disorder

Abstract Background The number of individuals who are diagnosed with attention‐deficit hyperactivity disorder (ADHD) during adulthood has increased in recent years. However, there is still no decision aid (DA) to help adults newly diagnosed with ADHD make decisions regarding further treatments. Objective This study aimed to describe the development process of a DA for adults newly diagnosed with ADHD and its field testing during the shared decision‐making (SDM) process in a clinical setting. Methods The development process involved the creation of a DA prototype using the International Patient Decision Aid Standards criteria and revision of the prototype through the stakeholders' reviews. The field testing of the DA compared scores before and after the SDM process on the service users' knowledge scale, decisional conflict scale and the Conners Adult ADHD Rating Scales. Results The developed DA contained options of watchful waiting with own coping skills and pharmacological treatment, which consisted of several kinds of drug options. Fifteen adults newly diagnosed with ADHD participated in the field testing. The participant decision‐making quality outcomes such as their knowledge and decisional conflict improved after the SDM process. ADHD severity did not change. Conclusion A DA for adults with ADHD was systematically developed following the international criteria. Field testing indicated that the DA could serve as a tool to facilitate the SDM process. Further research on this DA is necessary before its routine implementation. Patient or Public Contribution During the development process of the DA, the service users who had already been diagnosed with ADHD reviewed the DA prototype and provided feedback, which improved the final version of the DA.


| INTRODUCTION
Attention-deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterized by the following behaviour-related symptoms: inattention, hyperactivity and impulsivity. 1 Although ADHD had been considered to be limited to childhood, research over the last few decades has provided knowledge that most children with ADHD maintain at least some symptoms into their adulthood. 2 The prevalence of adult ADHD is estimated at 1.2%-3.2%. 2,3 Hence, there are a considerable number of adults who are suffering from ADHD symptoms. Moreover, in recent years, the increasing number of workers with depression has become a major social problem. As a background, there appear to be many workers who are secondarily developing depression while trying to cope with struggles related to ADHD symptoms. The societal cost due to the increase in ADHD prevalence in the United States is between $143 billion and $266 billion annually, which is mainly attributed to the low productivity and low income of adults with ADHD who are unemployed or absent from work. 4 Accordingly, it is urgently necessary to take measures against this issue. Some guidelines in several countries such as in the United Kingdom and Australia recommend lisdexamfetamine or methylphenidate extended-release oral suspension as the first-line drug for adults with ADHD. 5,6 Yet, there is no such guidance for adult ADHD treatment in Japan. Furthermore, due to its behaviour-related symptoms, it is important to take not only medication treatment but also psychoeducation that promotes behavioural changes. However, even in countries where they follow those existing medication treatment guidelines, when medication should be started and how to make decisions about whether to start taking medication or not has yet to be established.
Medical decision making has left traditional conventional ways, where physicians drive the decision-making process. 7 Rather, 'shared decision-making' (SDM) is increasingly promoted as a service usercentred care in various medical fields, including the mental health field. 8 Particularly for people with mental health conditions, SDM is a central part of the current recovery movement, which is based on the service users' right to autonomy and self-determination. 8,9 Decision aids (DAs) are clinical tools that aim to facilitate SDM between service users and clinicians for a specific condition with a further treatment decision. 10 DAs reduce decisional conflict, promote service users' knowledge, improve their satisfaction regarding their choice and ensure the congruency of their choice to their personal values. 11 A DA for parents of children with ADHD who are faced with the decision about ADHD treatment has been developed and reported. 12 However, to the best of our knowledge, there are as yet no published tools for adults with ADHD who are faced with the decision of their treatments.
The aim of this study was to describe the development process of a DA for adults newly diagnosed with ADHD and its field testing during the SDM process in a clinical setting.
Our hypotheses in the field testing were that the use of the DA during the SDM process would reduce decisional conflict and increase knowledge regarding ADHD. We also assessed if the DA, which included examples of behavioural changes to cope with ADHD symptoms, would reduce ADHD severity.
The DA developed in this study is anticipated to improve the quality of initial care for adults newly diagnosed with ADHD. This service user involvement approach might have a potential positive impact on the abilities of these adults to cope with ADHD symptoms.
2 | METHODS 2.1 | Development, review and revision of a DA prototype The content of a DA prototype was incorporated by findings from the qualitative need's assessment interviews, which were already reported elsewhere, 13 and researchers developed the prototype in accordance with the quality criteria established by International Patient Decision Aid Standard. 14 The prototype was then reviewed by stakeholders, such as service users and health professionals. Individuals diagnosed with ADHD during adulthood were approached at follow-up appointments of the outpatient service. Health professionals who regularly see adults with ADHD at the same outpatient service were also approached. They were welcome to write any comments directly on the prototype while reviewing it. The readability and understandability of the DA prototype, including the length of explanation, amount of information and balance of related information were assessed. Trends in responses and narrative feedback were collected, and similar comments were assembled. The researchers then discussed the input from the stakeholders, which was used to improve the DA prototype.

| Field testing the DA
The developed DA was then field-tested during the SDM process in a clinical setting described below.

| SDM programme for psychiatric outpatients
We conducted field testing of the DA using a clinical SDM process that we developed and reported previously. 15 The SDM programme comprises the three steps as described below.
Step 1. Initial consultation: Option presentation consultation: After the psychiatrist informs the adult of the diagnosis as ADHD, further treatment options such as watchful waiting with coping skills or additional medication with coping skills are shared between the adult and the psychiatrist using the DA booklet.
Step 2. Deliberation outside the service: The participant goes home with the DA, and freely reviews and considers it.
Step 3. Decision-making consultation: At the next appointment, the participant sees the psychiatrist. Both parties discuss the treatment options using the DA and finally decide which treatment can be further taken by the participant. (ii) current substance dependence and abuse; and (iii) unable to speak Japanese. Participants requiring hospitalization in the psychiatric ward due to symptom severity or suicidality were also excluded and referred to applicable psychiatric services. Seventeen individuals who fulfilled the inclusion criteria were approached after the initial consultation. The sample size was selected in accordance with the methods used in the DA literature for field testing. [16][17][18] Two of the 17 individuals withdrew their agreements immediately after providing the written consent: one moved to another service and the other could not revisit the service owing to a weather disaster. Participants filled out the questionnaires immediately after the initial consultation (baseline), immediately after the decision-making consultation, and in the 1-to 2-month follow-up at the outpatient services.

| Measurements
Baseline-filled the questionnaires immediately after the initial consultation (a) Preferences for roles in decision making: We used the Control Preference Scale (CPS) 19 to assess the participants' preferences for roles in decision making. We used the Japanese translation version of the CPS. The CPS comprises the following items: (i) clinician should 'make the decision using all that is known about the medicines'; (ii) clinician should 'make the decision but strongly consider [patient's] opinion'; (iii) patient and clinician should 'make the decision together, on an equal basis'; (iv) patient should 'make the decision but strongly consider the clinician's opinion'; and (v) patient should 'make the decision using all the patient knows or learns about the medicines'.
The previous study using the Japanese version of the CPS demonstrated inter-rater reliability with a substantial level of agreement (κ coefficients = 0.61). 20 (b) Decisional conflict: We assessed decisional conflict, defined as uncertainty about the course of action to take when choosing among several medical procedures, 21 using the Japanese version of the decisional conflict scale (DCS). 22 The DCS comprises 16 items and the following five subscales: feeling informed, having clear values about benefits and risks, support to take the decision, uncertainty, and perceived effectiveness of the decision. The items are scored from 0 (strongly agree) to 4 (strongly disagree), with higher scores indicating a higher decisional conflict. The total scores range from 0 (no conflict) to 100 (maximal conflict). Scores lower than 25 are associated with implementing decisions, and those above 37.5 are associated with decision delay or feeling unsure about implementation. 21 The scores on the subscales of the Japanese version of DCS demonstrated high internal consistency (Cronbach's α = .84-.96). 22 (c) Knowledge: Participants' knowledge regarding ADHD and its treatment was measured using a questionnaire containing 18 items with the response options 'true', 'false', and 'don't know'. Of the 18 items, 13 items were presented in the DA and 5 items were not. The number of items, which were answered correctly within each subgroup, that is, the items presented in the DA and those not presented in the DA, was calculated. We developed this questionnaire for this study based on knowledge measures used in the previous ADHD study 12 with the developer's permission. We used 13 items from measures in Brinkman et al. 12 and 5 of our own items. Medication treatment options available for ADHD vary widely from country to country. Our own items were based on information regarding medication treatment options currently approved and marketed in Japan. The questionnaire was reviewed by the authors, including ADHD experts for content validity.
(d) ADHD severity: We assessed ADHD severity using Conners' Adult ADHD Rating Scales-Self-Report: Long version (CAARS-S: L). [23][24][25] The CAARS-S: L includes 66 questions and consists of eight subscales: inattention/memory problems, hyperactivity/restlessness, impulsivity/ emotional lability, problems with self-concept, DSM-IV inattentiveness symptoms, DSM-IV hyperactivity-impulsivity symptoms, DSM-IV ADHD symptoms total and ADHD Index. The answers were evaluated using a 4-point Likert scale with four options: 0: almost never, never; 1: occasionally, sometimes; 2: most of the times, usually; 3: very often, always. We used the Japanese version of CAARS-S: L. [23][24][25] The scores on the subscales of the Japanese version of CAARS-S: L demonstrated good internal consistency (Cronbach's α = .73-.88). 25 Post-filled the questionnaires immediately after decisionmaking consultation (a) How decisions were made: We used the scales developed by Strull et al. 19 to assess how the decision was made. The scales comprise the following items: (i) clinician 'made the decision using all that is known about the medicines'; (ii) clinician 'made the decision but strongly consider [patient's] opinion'; (iii) clinician and patient 'made the decision together, on an equal basis'; (iv) Patient 'made the decision but strongly consider the clinician's opinion'; and (v) patient 'made the decision using all [the patient] knows or learns about the medicines'.
(b) Decisional conflict: We assessed decisional conflict using the Japanese version of the DCS. 22 (c) Knowledge: Participants' knowledge regarding ADHD and its treatment was measured using exactly the same questionnaire that was administered after the initial consultation.
One-to 2-month follow-up ADHD severity: Within the 1-2-month follow-up after the decisionmaking consultation, we assessed ADHD severity using the Japanese version of CAARS-S: L 24,25 as a long-term follow-up.

| Data analysis
We assessed the concordance between preferences for a role in decision-making and how decisions were made. We combined the three categories reflecting participant involvement into one category and contrasted it with the categories of the clinician-alone and patient-alone decision-making. Gwet's Agreement Coefficient (AC 1 ) was used to determine the concordance.
For the knowledge, decisional conflict and ADHD severity, we used a paired t-test to evaluate for significant differences between the before-and after-SDM process if the data were normally distributed. Otherwise, we used a Wilcoxon signed-rank test. The mean score and associated standard deviation (SD) were also calculated.
This study protocol was approved by the Ethics Board at St.

| Development, review and revision of a DA prototype
The developed DA prototype consisted of a 20-page A5 paper prepared as a booklet. The needs assessment interviews suggested that individuals diagnosed with ADHD during adulthood experienced difficulties in accepting their diagnosis and had identity concerns just after the diagnosis. 13 Therefore, in the DA prototype we attempted to provide appropriate evidence-based information about ADHD to promote self-understanding and reduce stigmatized attitudes towards ADHD. The DA prototype then contained options of watchful waiting with own coping skills and pharmacological treatment, which consisted of several kinds of drug options. Table 1 shows the contents and rationales of the DA prototype.
Five service users then reviewed the DA prototype (Supporting Information Appendix S1). There were some comments unique to ADHD (e.g., too colourful/decorative to concentrate on reading). We then avoided unnecessary embellishment and used only two colours.
For the description of condition and coping skills, the service users gave additional examples from their own experiences. We referred to these additional examples. Five psychiatrists also reviewed the DA prototype (Supporting Information Appendix S2). Similarly, to the service users, there were suggestions to hesitate using decorations and many colour fonts. Although psychiatrists were familiar with percentage and pie chart, we did not address them because we adopted a more userfriendly description. A single cycle of review and revision occurred for both the service users and the psychiatrists. Thereafter, through the process of the stakeholders' reviews, the final version of the DA was developed. Supporting Information Appendix S3 shows the final DA containing both the Japanese version and the English version.

| Summary of participants
Participants were 15 adults newly diagnosed with ADHD. The mean age was 42.4 years. Table 2 shows the demographic characteristics and treatment decision-making of the participants. There were no participants who dropped out during the SDM process. Accordingly, all the participants experienced the three steps in SDM: the option presentation consultation, deliberation outside the service and the decision-making consultation.

| Concordance between role preferences and experienced decision
Regarding preferences, 14 (93%) of participants preferred patient involvement in decision making, while only 1 (7%) preferred clinicianalone decision-making and none preferred patient-alone decisionmaking. Regarding practical experiences, 14 (93%) reported that they were involved in the decision-making, while only 1 (7%) answered that the clinician made the decision, and none chose patient-alone decision-making. The concordance between role preferences and experienced decisions (15 pairs) was AC 1 = 0.88 (0.60-1.09). This indicated that it was more than a coincidence.

| Participant decision-making quality outcomes
(a) Decisional conflict: The participants' mean total decisional conflict score at baseline was 56.4 (±20.0). After the SDM process, the mean score was 32.8 (±14.4) (p = 0.001), which indicates that their conflicts significantly improved, and they were feeling more confident about their decisions. All subscales were >37.5 at baseline, indicating that the participants were feeling unsure about the implementation of each category (informed, value clarity, support, uncertainty and effectiveness); however, they all significantly improved after the SDM process. The mean subscales, other than 'uncertainty', after the SDM process were <37.5 (Table 3).
(b) Knowledge: The participants' mean knowledge score of the specific items mentioned in the DA improved from 5.8 (±3.3) at baseline to 9.7 (±2.2) after the SDM process (p = 0.001). The participants' mean knowledge score of the items not mentioned in the DA also improved after the SDM process (p = 0.003) ( Table 3).

| ADHD severity
There was no significant change between the baseline and the 1-2month follow-up regarding any subscale (Table 4).

| DISCUSSION
To our knowledge, this is the first study to develop a DA for adults newly diagnosed with ADHD and to conduct field testing of the DA during the SDM process in a clinical setting.
The findings indicate that adults with ADHD are able to participate in the SDM process while acquiring the relevant AOKI ET AL. Objective information such as diagnostic criteria, prevalence rate, comorbidity  There were some limitations in this study. First, the sample size was relatively small because we recruited the participants in the services where the SDM programme had been introduced.
Second, because of the exploratory nature of this study as a field testing, the evaluations were not compared with adults newly diagnosed with ADHD who had decided on further treatment without the DA, and who were not involved in treatment decision-making. As the international criteria 14 indicate, further studies that will incorporate a control group are necessary. Third, we used the knowledge scale that had not been tested in a Japanese sample before this study. Moreover, the current study was conducted in psychiatric services familiar with SDM; the implementation and widespread usage of this DA in other facilities may require an appropriate SDM training programme. Nonetheless, the findings show that the participants utilized the DA during the SDM process in a clinical setting. There are two ways adults are usually diagnosed with ADHD: (1) they are already receiving treatment for another psychiatric diagnosis (e.g., depression) and then are diagnosed with ADHD, or (2) they are uncertain about their condition and seek ADHD diagnosis on their own. 28 The latter has been increasing with the spread of informational media on developmental disorders. 29 Whichever the case, as the results showed, the developed DA during the SDM process in the present study is a practical tool for adults newly diagnosed with ADHD. Furthermore, the pharmacological treatment options of ADHD are rapidly advancing. Our DA will need to be updated in accordance with the latest situation regarding available treatment options.

| CONCLUSION
We systematically developed a DA for adults newly diagnosed with ADHD following the international criteria. The field testing suggests that the successfully developed DA could serve as a tool to facilitate SDM in clinical settings. Further research on this DA is necessary before its routine implementation. The results shown are based on 13 participants who had complete data at baseline and post-SDM.