Development of a patient decision aid for superficial basal cell carcinoma

Dear Editor, Patients with superficial basal cell carcinoma (sBCC) may be offered several treatment options including surgery, imiquimod, 5‐fluorouracil (5‐FU) or photodynamic therapy (PDT). ¹ , ² Patient decision aids (PDAs) are tools to assist patients and physicians in shared decision making; a recent study showed that patients with BCC would like to participate in decision making. ³ Stacey et al. provided evidence showing that PDAs helped patients improve knowledge of their disease and possible treatments, and perform risk assessment. ⁴ Junn et al. recently described the development of a paper‐based PDA for patients with sBCC with limited life expectancy that weighs the benefits and risks of treatments vs. watchful waiting. ⁵ We describe the development of a digital PDA for all patients with sBCC. The PDA was developed in line with the International Patient Decision Aid Standards. ⁶

Phase 1: content development. The Dutch Association for Dermatology and Venereology approved the PDA development. A literature review was performed to obtain evidence for the PDA’s content: (i) effectiveness (recurrence rates) of surgery, 5‐FU, imiquimod and PDT; (ii) side‐effects and complications; (iii) cosmetic outcomes; (iv) treatment regimen (at home vs. in hospital, frequency, duration); and (v) patient preferences and values (qualitative research). Information on cryotherapy and electrodesiccation and curettage was not included, because these treatments are reserved for patients who desire quick treatment. It was assumed that these patients will not benefit from a PDA. To evaluate which values Dutch patients deemed important, our research group conducted a survey. ⁷ The part on ‘value and preference elicitation’ was based on the literature search (international) and the survey (national).

Phase 2: alpha testing with focus groups. Alpha testing is an umbrella term for gathering feedback on the content, graphics and usability of the PDA from patients and professionals. A first draft of the PDA was designed as a mock‐up version with a set of images that look and work like actual but simplistic websites. We organized a semistructured patient focus group to evaluate this draft and explore whether all topics were covered.

From the dermatology department of a university hospital (MUMC+), 21 patients (minimum 18 years old) with a history of sBCC were invited for the focus group; eight patients were included (three men and five women). The mean age was 63·5 years (range 50–77) and six patients had a high education level. The discussion was audio recorded, transcribed verbatim, analysed and coded using the qualitative data software package NVivo 11a (QSR International, Doncaster, Australia). Patients provided feedback on three topics: (i) photographs of sBCCs should be optional, (ii) information concerning the metastatic potential of BCC could cause worry, and (iii) information on Mohs surgery was lacking.

The PDA was adapted according to the feedback and an interactive web app was developed and tested in a second focus group. A noninteractive version of the PDA is available via Figshare (10.6084/m9.figshare.13117598). The second focus group consisted of five dermatologists with 1–14 years of experience. Their discussion points were similar to the patients’ with regard to the photographs and information on metastatic potential, although they advised not to include information on Mohs surgery because it is not a standard treatment for sBCC in the Netherlands. The results of both focus groups and the changes made to the PDA are summarized in Table 1. After testing the PDA the text was rewritten by a Dutch publishing agency to improve comprehensibility for people of all levels of education.

Table 1.

Outcomes of alpha testing a patient decision aid (PDA) for superficial basal cell carcinoma (sBCC)

Topic	Patients	Adaptions	Professionals	Adaptations
General	Attractive layout	NC	Attractive layout	NC
	The PDA should be open access, available to all patients	NC	Strive for national use. In order to do so give all treatment options attention (also less effective, less frequently used treatments)	Cryosurgery and curettage and electrodesiccation were excluded; both patients and professionals agreed
Images and visual display	Opinions on showing pictures of sBCCs were divided	Link to optional photo page with examples of sBCCs	The image on incidence of sBCC is unclear	Changed the image to 100 ‘persons’, 20 highlighted
			Improve quality of photographs	Uploaded new sBCC photographs
Pros and cons of treatments	Positive and negative explanation of results adds to the comprehensibility	NC	Change pros and cons to treatment characteristics	Changed
Value clarification	Every patient will state that all statements are very important	Patients have to prioritize statements	No comment	NC
Content of information	Information on different subtypes of BCC is necessary	Added information on subtypes in general information section	Wondered if all BCC subtypes should be discussed	Removed this section and checked with patients during interviews
	Statement on metastases is worrying	Nuanced statement	Change sentence to clarify that BCC very rarely metastasizes	Changed sentence to ‘BCC very rarely metastasizes’
	Mohs surgery is not an included treatment option; it should be	Did not include extra section, but added statement on Mohs surgery	Concerned about patients without indication asking for Mohs	Removed statement saying patients with indication for Mohs will not get PDA
	Add statement on what happens if treatment does not work	Added statement	Add information for use of creams	Added information
	Inform about timely cessation of noninvasive treatment	Under treatment duration changed ‘6 weeks’ to ‘maximum 6 weeks’	Add preventing ultraviolet exposure after PDT	Added information
			Specify control after ‘several months’	Specified information
Sequence of PDA sections	Logical order	NC	Logical order	NC
	Personal information at the end	Moved personal information	No comment	NC
Comprehensibility	Minor textual changes in different sections	Changed text where appropriate	Minor textual changes	Changed text where appropriate
	Work with bullets for numerations	Added bullets	No comment	NC
References	No scientific articles. Show guidelines and pamphlets	Altered reference list	Refer to patient information provided by NVDV	The patient information of the NVDV will be used

The results were analysed and coded using a qualitative data software package, QSR NVivo 11a. NC, no changes; NVDV, Dutch Association for Dermatology and Venereology; PDT, photodynamic therapy.

Phase 3: project team and patient interviews. The PDA was evaluated by a project team consisting of dermatologists from academic and general hospitals (with or without dermato‐oncology interest), a dermatology resident, patient representatives, a physician assistant, an epidemiologist, a software developer, a technical physician and a health technology assessment researcher. The project team gave written feedback on the final content of the PDA, which was analysed, prioritized and discussed in the research team (L.C.J.v.D., N.W.J.K.‐S., B.A.B.E.). Next, interviews were performed with patients by telephone or in person. Usability, workflow, interaction of patients with the PDA, and comprehensibility were evaluated using a think‐aloud method (to find out how a device is used in a simulated real‐life situation). Interviews were performed until sampling saturation, and then audio recorded, transcribed and analysed. During the interviews with five patients, we evaluated all changes made in phase 2. Only minor details and final ‘bugs’ were adapted. All considerations including references were documented in a background document (available on request from the authors).

In conclusion, there is sufficient evidence that dermatology patients would like to be involved in decision making. Consequently, shared decision making in dermatology has been gaining interest fast. This article shows that the input of patients and physicians improved the comprehensibility and usability of the PDA. Testing this PDA in patients with newly diagnosed sBCC is essential to evaluate whether the PDA results in better knowledge, decreased decisional conflict, and more contentment with their decision.

Author Contribution

Lieke Clasina Johanna van Delft: Conceptualization (lead); Data curation (lead); Formal analysis (lead); Funding acquisition (lead); Investigation (lead); Methodology (equal); Project administration (lead); Resources (equal); Visualization (equal); Writing‐original draft (lead); Writing‐review & editing (equal). Brigitte Agnes Essers: Conceptualization (equal); Investigation (equal); Methodology (equal); Supervision (equal); Validation (equal); Writing‐original draft (equal); Writing‐review & editing (lead). Patty Nelemans: Conceptualization (supporting); Formal analysis (supporting); Methodology (supporting); Supervision (supporting); Validation (equal); Writing‐review & editing (lead). Klara Mosterd: Conceptualization (supporting); Supervision (supporting); Visualization (equal); Writing‐review & editing (lead). Nicole WJ Kelleners‐Smeets: Conceptualization (lead); Data curation (equal); Formal analysis (supporting); Funding acquisition (supporting); Investigation (supporting); Methodology (supporting); Supervision (lead); Validation (equal); Writing‐original draft (equal); Writing‐review & editing (lead).