Evaluating the readability of patient-facing documents

Patient-facing documents or information, depending on the device in question, may include pamphlets, instructions for use, a summary of safety and clinical performance (SSCP), labeling on the device, or an implant card. These documents are responsible for telling users how to operate their medical device, letting them know what mistakes to watch out for and how to recognize unsafe situations, or providing information about the medical device, its use and alternatives. Even when users have received training (which is not always the case), these documents are intended to help guide them through use.

Too often, they do not succeed in this: Users do not understand exactly what to do. They make mistakes. They're left uncertain. They don't clean parts properly. Not because they are incompetent, but because the information they received was insufficient.

How do medical device manufacturers (or other interested parties) know if their patient-facing documents are good or bad or somewhere in between? The answer, as it often is, is to ask the users.

Quality criteria for good documents include some obvious criteria: readability – the intended user group should be able to understand the words and sentence structures used; understandability – the combined words and sentences should make sense to the reader; and applicability – users should be able to take what they've read and then operate their device. However, there are less obvious criteria, too: Findability – can users find the information they are looking for? Perceivability – do users recognize important information? Comprehensiveness – is all necessary information included? And motivation – are the documents engaging enough to get users reading them?

By taking these criteria into consideration, an evaluation plan with tasks designed specifically for the documents at hand can be crafted. A variety of methods not only allows differing criteria to be examined but helps maintain participant engagement. Each document and each evaluation plan are unique, but there are strategies that often allow maximum information to be collected. A small selection includes:

• Representative and varied users: The best people to evaluate patient-facing documents are the users they are intended for.
• Scenario-based tasks: a short description of a situation in which one or more users are performing a task or multiple tasks, followed by questions for participants. Questions may address mistakes characters made or did not make, or ask the respondent to explain what comes next.
• Root-cause analyses: interviews with respondents to understand why an unexpected/unintended response was given and to gain insight into optimization potential.

With representative users' help, documents can be constructed in an engaging and helpful manner.

Torsten Gruchmann