Our methods were informed by Coulter et al.’s systematic process for the development of patient decision aids [12]. The process of development and alpha testing the comprehensibility and usability of the CPtDA is outlined in Fig. 1.

Fig. 1

Development process of the consultant patient decision aid (CPtDA)

2.1 Defining the Purpose, Scope and Target Audience

When developing the evidence-based guideline for deprescribing ChEIs and memantine [6] in 2019, it was recognised by the guideline development team that there is an unmet need for a complementary decision aid. The purpose, scope and target audience of the CPtDA was informed by the scope of the guideline. However, for clarity, the research steering group (SG) decided that the CPtDA should focus solely on ChEIs, with the potential to develop a separate CPtDA for memantine in the future.

Purpose: to enable shared decision-making and support people living with dementia and/or their carers to make informed decisions based on their values and preferences.

Scope: the ‘decision’ to trial discontinuation (through tapering, i.e. deprescribing) versus continuation of ChEIs. Applicable to any adult taking a ChEI for cognitive impairment.

Target audience: people living with dementia and their carers in conjunction with a clinician such as a general practitioner, geriatrician, pharmacist or nurse.

2.2 Assembling the Research SG

To develop the CPtDA, we assembled a research SG consisting of three pharmacists, a carer of a person living with dementia, a trainee geriatrician and two geriatricians, one of whom is also a clinical pharmacologist. The role of the SG was to overlook and review the feedback and input gained from participants to ensure that all views and voices were considered.

2.3 Reviewing and Synthesising the Evidence and Determining the Format

To develop the evidence-based clinical practice guideline for deprescribing ChEIs and memantine, a systematic review was undertaken to determine the potential harms and benefits of deprescribing ChEIs. GRADE methods were then followed to convert evidence to recommendations, which consider various factors including consumer values and preferences. Additionally, the components of the CPtDA were informed by the International Patient Decision Aids Standards [11] and Item 11 of the Standards for UNiversal reporting of patient Decision Aid Evaluations (SUNDAE) guidelines [13].

2.4 Drafting the CPtDA Ready for Alpha Testing

To satisfy the required components of the CPtDA according to the International Patient Decision Aids Standards we:

Included an explicit description of the decision to reduce, stop or continue their ChEIs.

Described the health problem the CPtDA is trying to address, which is optimising the use of ChEIs in people living with dementia.

Provided information on the benefits and harms of using ChEIs.

Created a template to allow consumers to clarify their values to make the decision to reduce, stop or continue ChEIs.

In addition to the CPtDA, we also created a 2-page deprescribing plan template with sections on tapering and monitoring that could be used if a decision was made to trial discontinuation. Knowledge of ‘how’ to deprescribe is highly valued by consumers and planning for tapering and monitoring is an essential part of the deprescribing process [14, 15]. In this article, we include the deprescribing plan template when referring to the CPtDA.

Throughout the drafting process, the readability of the content was checked according to the Flesch–Kincaid Grade Level Score and the Gunning Fog Index, aiming for a grade level of 8 so that it is readable for the general public [16]. We used these tools to ensure our phrasing and content were more readable. The first draft of the CPtDA (pre-alpha tesing) is available as Electronic Supplementary Material (ESM).

2.5 Conducting Interviews to Alpha Test the CPtDA

We included those who are aged 18 years and over who have a lived experience with dementia. This included people who are living with dementia of any type, memory problems or mild cognitive impairment. We also included carers of people living with dementia and healthcare professionals who have experience caring for people living with dementia including general practitioners, geriatricians, medical trainees, neurologists, clinical pharmacologists, pharmacists, registered nurses or nurse practitioners. We excluded individuals who were unable to communicate in or read English.

We obtained written informed consent from people living with dementia and their carers. We obtained implied consent from healthcare professionals (i.e. their consent was determined via them agreeing to participate in the interview). We identified and recruited potential participants via personal contacts, networks and advertising through StepUp for Dementia, a registry of consumers who are interested in participating in dementia-related research. We also identified participants via professional organisations, via geriatricians at the Royal Adelaide Hospital’s geriatric outpatient department, personal contacts and snowballing, where participants are asked to suggest other possible participants. We applied a purposive sampling approach to include the perspectives of a diverse group of people who may be the potential end users of our CPtDA in clinical practice. We aimed to recruit people from various disciplinary healthcare backgrounds and consumers living in different regions (e.g. states) and with varying experience with these medications.

The target sample size was five to ten participants per group to gain diverse perspectives of end users, guided by sample sizes of similar previous studies [17, 18]. Recruitment continued until the SG felt that no further changes to the CPtDA were required. We were also guided by the sample size of previously conducted similar research and aimed to gain diverse perspectives from end users [17, 18].

We invited participants to an interview that took approximately 30–60 minutes. Participants were only interviewed once. A copy of the CPtDA was provided to participants for them to read 1 week prior to the interview. The CPtDA was sent electronically or via post depending on the preference of the participant. Healthcare professional participants had the option of providing feedback via e-mail (rather than interview); however, no participants took this option.

Interviews were conducted online with videoconferencing software (Zoom®), or via the telephone and were conducted one-on-one with the participant or with person-carer dyads. We developed the interview guide from previous studies related to user testing of decision aids (Table 1) [19, 20]. This guide consisted of questions grouped in three main sections:

1.

Their general impression of the CPtDA and its purpose.

2.

The content, wording, accuracy and visual appearance of the CPtDA.

3.

Their perspectives on the usability and implementation of the CPtDA in clinical practice.

A researcher, who is a pharmacist with experience working with older people and people living with dementia (NJA), conducted the interviews using the interview guide. During the interview, the researcher directly annotated the CPtDA to note the participants’ suggestions to improve the decision aid’s wording, content and formatting. Issues highlighted by participants could be clarified and suggestions of wording from participants obtained. For example, if there was a sentence that was unclear, the researcher explained the intended message of the sentence and asked the participants how it could be phrased better. The interviews lasted for 15–30 minutes and were not audio-recorded. Participants were provided with a $30 AUD gift card as an honorarium. Basic participant characteristic data were collected to describe the population (Table 2).

Table 2 Description of participant demographics and characteristics

Information gained during the interviews was used to make changes to the CPtDA iteratively. After every five to six interviews with roughly the same number of consumers and healthcare professionals, two members of the research SG (ER and NA) reviewed the comments and made changes to the CPtDA. In totality, three rounds of interviews were conducted with revision of the CPtDA draft occurring after the 5th, 11th and 17th (final) interview. All changes were shared with the whole SG for comment. After completion of all interviews, the research SG reviewed and revised the decision aid again, considering all the feedback and approved the final version (ESM).