People with Mild Cognitive Impairments (PwMCI’s) are generally older people within the 65+ bracket, who struggle more with their memory and completing complex tasks. While we have a growing ageing population globally, older PwMCI’s still continue to be over-looked in study design and usability studies. Our business development manager and HF expert, Natalie Shortt, explores how Human Factors specialists can take account of this important audience when inputting into the device development process.
When including older people in usability studies, there are occasions where it can be observed during testing that the individual appears to have poorer memory retention, poorer self-reflection or articulation and seemingly unclear decision-making. These attributes can have significant impacts on study outcomes, and unfortunately don’t always provide clear root cause information.
These attributes are signifiers of Mild Cognitive Impairment (MCI). Although this condition often doesn’t have a significant impact on daily life or usual activities, participating in an unfamiliar activity such as a human factors study can often exacerbate those symptoms.
The ageing population is an increasing consideration for those of us in the medical device space. By 2050, it is forecast that 2.1 billion people will be over the age of 60, counting for 26% of the global population. This is double the number of people over the age of 60 today.Noting the move towards more autonomy in managing our own health, together with the need to alleviate pressure on traditional point of care settings, designing with older users in mind has become more important. Given that a subset of older people are considered People with Mild Cognitive Impairments’ (PwMCI), how do we make sure their voices are heard, and their risk of using products is better understood and accounted for?
5 considerations to improve design for PwMCI in medical device development
1. Recognising and adjusting for PwMCI
Mild cognitive impairment can be tricky to spot or know how to adjust for in study environments. Some of the key symptoms that are valuable to understand as device designers and study facilitators are:
- Trouble following a conversation – try speaking in shorter sentences and asking clear questions. Give them as much time as needed to think and respond
- Anxiety – More than ever, try to foster a calm and friendly environment.
- Finding it hard to finish a task or follow instructions – understand these people in early stage work, so that studies can be designed where scenarios are broken into smaller chunks than might typically be used for late stage work
- Trouble finding the right word or with language – we don’t want to put words in people’s mouths, but if we can see them struggling, try to approach the same topic from a different angle, or encourage them to describe their feeling instead of defining them.
The list is not comprehensive, but these points are particularly important to note as we look at other considerations.
2. Recruiting study participants
Mild Cognitive Impairment is not diagnosed, and the individual may be unaware that they have it. It could also be considered a sensitive topic, so a big challenge is developing a recruitment strategy that can specifically target these individuals. When developing your screener, extra time should be taken to consider how to ask questions during recruitment that might allude to MCI, without being overt. It is a topic best to be sensitive around.
3. Building rapport
Being able to develop a rapport with participants quickly is always important. For PwMCI, this is even more crucial. It’s likely that there will be more unique and a higher volume of observations than usual. Although we know we aren’t testing the individual, the more questions around incorrect actions the more individuals can feel tested. Allow time to have a chat at the start of the session, and make sure to maintain a consistent level of support and rapport throughout.
4. Study design
When developing the study protocol, consider how you organise the time you have. Where we might usually provide a scenario with an ambiguous end point – ‘let me know when you believe you have completed the injection’ – we need to consider shorter scenarios and end points, such as ‘let me know when you have chosen your injection site’. Consider providing goals written down, so they can refer to this as needed. Thinking about risk management and reasonably foreseeable mis/use, take more time to understand the support system around these people. Where we are observing individuals acting alone in a simulated situation, the reality may be that they would have people around them who would help, or they would be able to ring a helpline etc. These considerations all contribute to the context of their use, and therefore the risk-profile of your device.
5. Session design
PwMCI need certain allowances in study sessions to enable them to feel comfortable to go at their own pace. Taking everything into account so far, the most important thing to do is extend the session length compared to what you might expect is needed under typical circumstances. Watching PwMCI engage with a product is incredibly insightful into the realities of how someone might try their best to engage with the product, but this can be cut short or not properly explored qualitatively if the session length is too short.
Currently, in usability engineering, we account for the ageing population generally by making sure to include older intended users in usability studies, considering the potential comorbidities facing our patient populations, and understanding the spread of ages in relation to diagnosing conditions and prescribing therapies. Taking into account the realities they face that make them distinct from other user populations – such as Mild Cognitive Impairment – can enable us to improve the way we conduct such studies, and glean richer insights as a result.
To find out more about how we can support your Human Factors and medical product development needs, please do get in touch.