Adaptation and qualitative evaluation of Ask 3 Questions — a simple and generic intervention to foster patient empowerment

Abstract Background Patients are often not actively engaged in medical encounters. Short interventions like Ask 3 Questions (Ask3Q) can increase patient participation in decision‐making. Up to now, Ask3Q was not available in German. Objective To translate Ask3Q and evaluate its acceptability and feasibility. Methods We translated and adapted several English versions of Ask3Q using a team translation protocol and cognitive interviews. Acceptability and feasibility of the final German Ask3Q version were assessed via focus groups and interviews with patients and healthcare professionals (HCPs). Data were analysed via qualitative content analysis. Results Translation and adaptation were successful. Participants of focus groups and interviews perceived Ask3Q as a tool to empower patients to ask more questions. Moreover, it was seen as a guideline for physicians not to forget conveying important information. Several characteristics of patients, HCPs, the clinical setting and the intervention were identified as facilitators and barriers for an effective implementation of Ask3Q. Conclusion We provide the German version of Ask3Q. According to participants, implementation of Ask3Q in the German healthcare system is feasible. Future studies should evaluate if positive effects of Ask3Q can be replicated for patient participation and communication behaviour of HCPs in Germany.


| Study design
We conducted a two-phased qualitative study. In the first phase, we developed a German Ask3Q by translation and adaptation of English Ask3Q versions. In the second phase, we assessed acceptability and feasibility of the German Ask3Q by focus groups and individual interviews. To report this study, we used the Consolidated criteria for reporting qualitative studies (COREQ, see Data S1).

| Translation
We translated the seven different currently available versions of

| Adaptation
To assess comprehensibility of all translated Ask3Q versions, we conducted cognitive interviews with a convenience sample of patients with a cancer disease. 39,40 Cognitive interviewing is a method for pretesting translations in cross-cultural adaptation studies. [41][42][43] It helps to evaluate if the content to be tested is understood like its author intends. 42 Because of the convenience sampling approach, reaching theoretical saturation was not intended and difficult to obtain. Nevertheless, we could observe saturation in feedback and suggestions of our participants. Participants were recruited via outpatient clinics of a Comprehensive Cancer Center in Hamburg, Germany. A member of the study team (AL) personally invited participants to take part in the study. For details about researcher characteristics, the recruitment process and the setting of data collection, see Data S2. We developed an interview

SHORT INFORMATIVE
• Short question prompt lists like Ask 3 Questions (Ask3Q) can increase patient participation and shared decision-making.
• We provide the first Ask3Q intervention in German language.
• Ask3Q has the potential to motivate patients to ask more questions in a clinical encounter and can be used as a guideline for physicians to not forget to convey important information.
• According to participants of this study, implementation of Ask3Q in the German healthcare system is feasible if facilitators are considered.
• Future studies should evaluate if effects of Ask3Q can be replicated on patient participation in decision-making, question-asking behaviour of patients and communication behaviour of healthcare professionals in Germany.
guide based on recommendations by Willis et al. 39,41 Participants were asked for their comprehension of the different versions of the translated title, introduction, framing sentences and the three questions. We used verbal probing techniques like comprehension probes (eg 'What does the term 'healthcare' mean to you?') and paraphrasing (eg 'Can you repeat this sentence in your own words?'). We also asked which version of ASK3Q participants would find most useful during clinical encounters and for suggestions for further improvement of the different sentences and questions. We assessed demographic, clinical data, and health literacy (HLS-EU-Q16 44

| Data collection
To assess acceptability and feasibility of the German Ask3Q, we conducted focus groups with patients with a cancer disease, physicians and nurses, using a convenience sampling approach. Nurses and physicians, who were interested in participation but could not take part at the announced dates, were offered an individual interview. Participants were recruited via inpatient and outpatient clinics of a Comprehensive Cancer Center and outpatient oncology practices in Hamburg, Germany. A member of the study team (AL) invited participants to take part in the study either personally, via mail, e-mail or phone. For details about researcher characteristics, the recruitment process and the setting of data collection see Data S2. Each focus group was moderated by two researchers (AL, IS, PH, WF). Interviews were conducted by AL. Participants were offered a compensation of 25 Euros. All focus groups and interviews were audio-recorded and transcribed verbatim. We assessed demographic data of all participants, as well as clinical data, the Control Preference Scale (CPS 45 ) and health literacy (HLS-EU-Q16 44 ) of patients.

| Focus groups and interview guideline
Focus groups and interviews followed a semi-structured guideline [46][47][48] , which was not pilot tested. After a short introduction of the concept of Ask3Q, participants were asked about (1) acceptability (eg for patients: 'Would you like to use these materials in a clinical consultation?', for physicians/ nurses: 'Would you like to use these materials in your daily work?') and (2) feasibility (eg for all participants: 'Which conditions must be met in hospitals and practices, to use the material for patient empowerment in a reasonable way?').
Slightly different questions were used for focus groups with patients and HCPs (see Data S2).

| Data analysis
We calculated descriptive statistics using SPSS (IBM SPSS Statistics, Version 23). Transcripts were analysed using qualitative content analysis. 46,[49][50][51][52] Two team members (AL/MR) shared the task of primary coding of all transcripts and created a coding scheme with subcodes. Codings and coding scheme were discussed with a second team member (CT/AL) until reaching consensus. The coding scheme was slightly adapted after rereading all transcripts (AL) and discussion within the study team (AL, IS, PH). Analysis was facilitated using MAXQDA 12 (Verbi GmbH).

| Translation
Translators (PH, AL, IS) did not differ much in their translations. Only slight differences in the sentence structure or single words without differences in meaning could be observed. We reached consensus for translation of all Ask3Q versions within the first round of discussion (see Data S4). For cognitive interviews, we combined the different translated versions of the introduction and tested one introduction for the inpatient setting and one introduction for the outpatient setting. We combined the translations of the framing sentences and tested one version. We also combined two versions of question 2 because they only differed in one word ('harms' vs. 'risks'), which was translated to the same German word.

| Adaptation
We conducted cognitive interviews with n = 10 patients with a cancer disease. Interviews lasted 39.02 minutes on average. For demographic and clinical data of the participants, see Table 1.
In cognitive interviews, we tested one version of the title, two versions of the introduction, one version of the framing sentence and question 1, three versions for question 2 and five versions for question 3 (see Data S4). According to suggestions of participants, we added the word 'important' (German: 'wichtige') to the title of the German Ask3Q. Some participants were not sure about the correct meaning of the phrase 'about your healthcare' (German: 'über Ihre Gesundheitsversorgung'); therefore, we changed that phrase in the final version of the introduction to 'about your further treatment' (German: 'über Ihre weitere Behandlung'). Additionally, we decided to use one version for both inpatient and outpatient settings. We also rephrased the framing sentence according to suggestions of the participants. Questions 1 was well understood by all participants, so we did not have to change it. The different versions of question 2 were well understood by all participants. We choose the version, which was preferred by most participants and slightly changed wording according to participants' suggestions. The versions of question 3 differed in their content but were also well understood by most participants. However, there were different opinions about the most relevant and useful version of question 3. We decided for the version of question 3, which was preferred by most of the participants. For the final version of the German Ask3Q, see Data S4.

| Sample characteristics
Three focus groups with n = 24 patients with a cancer disease, one focus group with n = 5 physicians, and two focus groups with n = 13 nurses, as well as interviews with n = 1 physician and n = 2 nurses were conducted. Focus groups lasted 94 minutes on average.
Interviews lasted 48 minutes on average. For sample characteristics, see Tables 1 and 2.

| Advantages for patients
All participants positively appraised the German Ask3Q. According to most participants, Ask3Q has the potential to motivate patients to ask more questions and to actively engage in decision-making processes.
'But certainly, there are patients, who are still scared and to encourage them with these materials to think about that they have the possibility to ask questions, I like that'.

Focus group physicians, P04
Furthermore, Ask3Q could be used as a tool for patients to structure their questions and invites them to make notes before or after consultations.

| Advantages for HCPs
Participants noted that Ask3Q can also be used as a tool for HCPs to help them structure medical encounters without forgetting important information.

| Versatile usability
Most participants positively appraised that Ask3Q is a generic tool.
They supported the idea that patients with different diseases in different stages as well as patients' caregivers can use Ask3Q.
'And I also like that it is kept more general, that you don't need it just for one thing, or -that you theoretically could take this card with you to any physicians consultation'.

| Wording and phrases
Participants differ in their opinion about single words and phrases. Most participants highly valued the phrase 'watch and wait' because this option is often not discussed in clinical encounters.
However, single participants argued that 'watch and wait' is a TA B L E 2 Demographic data of participating healthcare professionals (HCPs) of focus groups and individual interviews with n = 15 nurses and n = 6 physicians  For the final coding scheme and additional quotes for the subcodes above, see Table 3.

| Facilitators for effective use of Ask3Q
Characteristics of Ask3Q, the setting, patients' characteristics, 'When it comes directly from the doctor or in the conversation, it is something different. Then I will sit down, then I will probably also think about it. This definitely addresses me more than just a flyer displayed somewhere'.

Focus group patients 2, P02
One nurse made a suggestion how to introduce the postcard to patients:

| Ways of dissemination of Ask3Q
While participants came up with a range of ideas to disseminate

| Time points for dissemination of Ask3Q
Some participants suggested that Ask3Q could be helpful at any time prior to diagnosis, during the first consultation, during the admission process to inpatient care, during ward rounds and at discharge from the hospital. Many participants supported the idea that Ask3Q should be provided as soon as possible and whenever a decision has to be made.

P05
For the final coding scheme and additional quotes for the subcodes above, see Table 3.  anticipate. This has to be evaluated in future implementation studies.

| Strengths and limitations
A strength of this study is its qualitative approach. In planning, conducting and reporting this study, we considered credibility, transferability, neutrality and dependability of our findings. Thereby, we could generate insights into acceptability and feasibility of Ask3Q from the target populations' view. To increase robustness of results, data analysis was conducted by two study team members and the refined coding scheme was re-applied to all the data.
This study comes along with several limitations. First, we did not perform a third round of cognitive interviews to test the final adaptations of Ask3Q. Second, we used a convenience sampling approach which might come along with a self-selection bias of participants interested in the topic. Additionally, most participants were patients and HCPs at one Comprehensive Cancer Center in Hamburg, Germany. Therefore, our findings might not be generalizable to other healthcare systems and/or other countries. Third, most patients were highly educated and native German speakers. Further research F I G U R E 1 Summarized results of qualitative evaluation of acceptability and feasibility of Ask 3 Questions should evaluate the intervention in a more diverse population, including vulnerable populations. 61 Additionally, we found a mismatch between the educational level and health literacy of patients taking part in focus groups. 62.5% of patients were highly educated but only 29.2% showed adequate health literacy. Despite the HLS-EU-Q16 is a well-established measure, [62][63][64][65] it was recently criticized for being not valid according to the concept of evidence-based medicine. 66,67 Since it was beyond the scope of this study, this should be analysed and discussed in further validation studies of the HLS-EU-Q16.
Fourth, it was difficult to recruit physicians for focus groups, leading to an overrepresentation of nurses in the sample of HCPs. Lack of time, less acceptability of the Ask3Q intervention, less interest in the topic or a too small financial incentive might be reasons for the low participation rate of physicians. 68 Nevertheless, since a broad range of sensitive topics were addressed in the group discussions, problems in the recruitment process might not have influenced the depth and quality of our data. 69

| CON CLUS ION
We provide the German version of Ask3Q. The German Ask3Q has the potential to empower patients and guide HCPs throughout medical encounters. Our study participants agreed that implementation of Ask3Q in the German healthcare system is feasible. Several facili-

ACK N OWLED G EM ENTS
We thank all our student assistants for their help preparing the study and the analysis as well as Heather Shepherd for giving the opportunity to translate the Ask 3 Questions intervention into German. We also would like to thank the University Medical

E TH I C S A PPROVA L A N D CO N S E NT TO PA RTI CI PATE
The study was approved by the Ethics Committee of the Medical Association Hamburg (Germany, study ID PV5368). The study was carried out in accordance to the latest version of the Helsinki Declaration of the World Medical Association. Principles of good clinical practice were respected. Data protection requirements were met. Study participation was voluntary. Participants received oral and written information and had the possibility to ask further questions.
They were informed about the data protection police of the study and gave informed consent to the recordings of the focus groups and interviews and to the recordings to be transcribed verbatim.

DATA AVA I L A B I L I T Y S TAT E M E N T
The data set collected and analysed during this study is available from the corresponding author on reasonable request due to ethical and privacy restrictions.