The developments taking place in the diagnosis of Alzheimer’s are controversial. It is therefore high time that we examined how to achieve responsible innovation in this area.

How can we responsibly translate new, fundamental scientific knowledge on Alzheimer’s into clinical practice, for example for diagnosis of the disease? In other words, how can we ensure good translational research into Alzheimer’s diagnosis?This research project showed that a wide range of practises are used in the diagnosis of Alzheimer’s in the Netherlands, and that these are based on different values and different interpretations of the disease. These practises need to be examined more closely if we are to achieve responsible innovation. We must also take into account a wider range of values, including quality of life values. The promise of early diagnosis using biomarker technology was made prematurely, and this should be taken into account when developing guidelines.

The researchers developed the “responsible innovation with care” approach for this project. This focuses on identifying existing medical practises; in other words, the processes by which healthcare institutions, doctors, researchers and other parties together handle diagnoses and patients. In these practises, the parties involved are constantly making improvements and assessing new technologies in terms of practical use and implications. The practises are also shaped by various societal and ethical values.

Project conclusions:

• There is a high degree of variation in current diagnostic practises in the Netherlands. This variation is the result of different values, but also different ways of dealing with scientific uncertainty. In the discussions surrounding translational research, insufficient emphasis is placed on the intended user practises of diagnostic innovations.
• Different ideas about what Alzheimer’s and dementia actually are and the types of problems we are faced with mean that different parties attach different meaning to the early diagnosis of Alzheimer’s disease. These underlying differences in opinion will not be easy to resolve.
• Responsible innovation in this field requires a thorough examination of the values that are at stake in existing diagnostic practises. Because these values are not always immediately clear to all stakeholders, it is generally not a good idea to start with deliberative/participatory methods such as scenario workshops.
• Effectiveness, safety, quality and cost are traditionally recognised as the relevant values in the healthcare domain. In addition, new quality of life values must be included in the design of diagnostic innovations, such as home care, self-management, emotional quality, pleasure and satisfaction.
• The stakeholder workshop identified various desirable and undesirable diagnostic scenarios. Responsible diagnostic innovation means that all parties work together to coordinate primary and secondary care, as a supplement to good self-management in the home setting.
• Biomarker technology conceptualises a medical disorder as a medical pathology (disease) and less as a subjective phenomenon (illness). Furthermore, it conceptualises medical disorders in quantitative terms. These two tendencies can lead to greater medicalisation and result in a greater gap between (a) an official diagnosis as being ill and (b) whether or not people see themselves as ill.
• Promises regarding early diagnosis are often made prematurely as it turns out to be not as simple as expected to assign meaning to biomarkers (certainly in the case of Alzheimer’s). We therefore need to be critical of new guidelines that anticipate that the use of biomarkers can be used to define disease.

Innovation with care

The many different Alzheimer’s practises are a result of the controversies that surround this disease. The analysis carried out in this project can provide direction for policymakers, research funding bodies, technology developers and guideline developers in:

• dealing responsibly with all these differences;
• thinking about what may be considered to be an improvement in practises.

The “responsible innovation with care” approach could also be applied to other diseases in the future.

Controversy

The developments taking place in Alzheimer’s diagnosis and their possible societal and ethical implications are regularly cause for discussion and controversy, both in the medical and in the public sectors. This is a highly complex, uncertain and dynamic field. As the researchers recently described in an article in the Dutch newspaper the Volkskrant, experts with widely varying research practises, problem definitions and approaches regularly disagree.

Some experts, for example, take a highly biomedical approach and regard Alzheimer’s as a terrible disease for which medical science must find a cure as soon as possible. Others take a more social approach, and believe that the severity of the symptoms depends on our definition of what constitutes a good life, what society finds “normal”, and the care arrangements in place.  

Interdisciplinary

In this project, researchers in philosophy/ethics and innovation studies worked closely together with researchers from the LeARN project (at the Center for Translational Molecular Medicine), which develops new tests that should enable a reliable diagnosis at an early stage using Alzheimer’s biomarkers.

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