Stage 1: Outcome measures and intervention feedback: content
Three haemodialysis patients and two carers (three females, two males aged between 51 and 60 years) who spoke English as a second or third language participated in the pilot testing process through two individual and one group interviews (with three participants).
The outcome measures were generally well received, but several changes were recommended. The ten-item K-10 measure offers response categories of five frequency levels related to the past two weeks while the nine-item PHQ-9 uses four frequency levels and is scored with reference to the last two weeks. The transition between the four week and two week time frames in the different scales was not easily followed by the participants, and required further explanation. Two K-10 questions (relating to the experience of ‘hopelessness’ and ‘worthlessness’) elicited a lack of verbal response. The researcher intentionally paused to provide time for participants to reflect on the questions and avoided rushing the response or interpreting silence as lack of understanding. Often the silence represented contemplation from which an answer later emerged. This approach was valuable but contributed to the length of the process. Where problems with understanding were encountered, alternative wording was discussed. After alternative words in English were presented, the group of three discussed the concepts in a common Aboriginal language (Pitjantjatjara) for several minutes before reaching consensus about alternatives. Alternatives proposed to the term ‘hopeless’ included ‘without hope’ ‘not feeling good, ‘waking up like there is no hope’, and ‘what’s the point of getting up’. An alternative to the term ‘worthless’ was ‘no one want to know you’.
One PHQ-9 question (‘Have you been talking slowly or moving around really slow?’) required further explanation. In addition, the transition from five frequency response options in the K-10 to four in the PHQ-9 led participants to request the missing category (‘some of the time’) as a useful available option. The EQ-5D was the easiest questionnaire to administer and was understood with ease in part because of its immediate time frame (today) but possibly also related to user-friendly and holistic attributes gained through its extensive development process within the multi lingual and multidisciplinary EuroQol Group [25]. There was nevertheless some difficulty in distinction between the ‘slight’ ‘moderate’ and ‘severe’ response categories for some items with participants struggling to identify the difference between the three options.
Participants responded positively to the Stay Strong App intervention, for example: ‘ewa (yes) other people would like it’; ‘when they see it (the people who keep me strong) on the app they’ll start talking’; ‘I think it’s really good’.
Stage 1: Outcome measures and intervention feedback: process
The assessment process included three components: completion of the three paper-based outcome measures; completion of the Stay Strong App intervention and completion of a semi-structured interview exploring ease of use, appropriateness and relevance of each tool. Feedback about the process of completing outcome measures and the Stay Strong App intervention was limited. There were positive comments: ‘good to answer’; ‘made me feel better’; ‘I really like that one, was good to talk about that’. On the other hand, there were also indications that the process was somewhat arduous with comments such as: ‘a lot to answer’; ‘too long’; ‘feel too tired’ with related body language noted during the session (standing up, walking away, or answering the phone). One participant suggested dividing the process into two separate sessions ‘Maybe next time catch up again’.
One other comment suggested the questions ‘need more explaining… it’s different English and Aboriginal and Torres Strait Islander languages… the words around feelings’. While another said, ‘That was a lot to answer in one go…(but) good to ask how I feel… let it out… made me feel better’. Distractions within the environment (noise, people and activity) also appeared to contribute to difficulty in attending throughout the assessments and intervention process. The researcher observed that fatigue or boredom appeared to relate to two issues: the length of the assessment process (influenced by the above-mentioned challenges of language and distractions within the environment), and repetition within the outcome measures. The repetition within the outcome measures occurs because there is considerable overlap between the PHQ-9 depression scale and the Kessler 10 scale. For example, both explore symptoms of depression using similar wording.
Stage 2. Outcome measures revision: forward translation
The research team undertook a four-step process of forward translation of the outcome measures. The first step involved determination of the eleven most widely spoken Aboriginal languages (including Kriol) in each of the two regions in which the research was undertaken through consultation between research team, and the Aboriginal Interpreter Service and service providers.
Stage 3: Paper to electronic outcome assessments with guiding protocols
Stage 4: Stay Strong App revision
The Stay Strong App has five sections: review of family, strengths, worries, and tips for wellbeing prior to setting life style goals for change. The expert panel reviewed the app and proposed changes. For example, given the specific dietary needs of renal patients some of the dietary suggestions within the app required adaptation. The recommended changes were then presented to the research team (Table 1). Further consultation within the team, the panel and with Aboriginal research team members led to revision of wording and images until consensus was reached.
Finalised tools
The completed Outcome Measures App is in electronic tablet format. Each of the three outcome measures (K-10, PHQ-9 and EQ-5D) is supported by 11 language options with visual cues and optional audio files. The revised Stay Strong App has incorporated the recommended wording and image changes. Both tools were finalised in preparation for use as assessment and treatment tools within a clinical trial of effectiveness of the MCP intervention for chronic kidney disease patients.