Patient reported outcomes (PROs) resources for digital mental health technologies

Patient reported outcomes (PROs) resources for digital mental health technologies (DMHTs)

Resources to help developers use patient-reported outcomes in digital mental health technologies for evidence generation, monitoring and user safety.

This summary provides developers with resources on integrating patient-reported outcomes (PROs) into the evidence generation and routine monitoring for digital mental health technologies (DMHTs).

PROs can provide valuable information from the individual’s perspective on outcomes such as:

- Symptom severity (e.g. PHQ-9 for depression and PANSS for psychosis)

- Health-related quality of life or health status (e.g. EQ-5D)

- Functional status (e.g. Work and Social Adjustment Scale)

- Personal recovery and goal attainment (e.g. Goal Based Outcome Tool)

It is important for developers to demonstrate that chosen PRO measures address clearly defined PRO objectives, are valid and appropriate for use in the target population in the specific clinical setting. Ideally, PROs should be standardised and should capture measures used in clinical practice.

The following considerations are intended to help support incorporating PROs in a manner that supports high-quality evidence and user safety.

1. Guidance and frameworks

- MHRA guidance on DMHT: device characterisation, regulatory qualification and classification clarifies when DMHTs, including those that incorporate or digitise PROs, qualify as software as a medical device (SaMD) and therefore need to be compliant with the medical device regulations. In summary if a DMHT has a medical purpose of helping diagnose, monitor or treat and is considered high functionality, it is likely considered SaMD.

- MHRA guidance on clinical investigations clarify when clinical studies involving medical devices need to be reported to the MHRA as a clinical investigation.

- The NICE Evidence Standards Framework for Digital Health Technologies (ESF) is a set of evidence standards for digital health technologies (DHTs). The ESF aims to help inform decision-makers, evaluators, purchasers and developers about the evidence required to assess DHTs within the health and care system. This includes guidance on demonstrating the effectiveness of digital health technologies, which may be relevant when considering patient-reported outcomes (PROs).

2. Applicable international standards

3. Ethical Guidance for PRO Clinical Research

The PRO Ethics Guidelines provide recommendations for ethical considerations relevant to digital mental health research. Key ethical considerations are:

- Participant Burden: It is important to balance the frequency of PRO assessments and notifications / reminders against the potential for participant fatigue or distress. One example of recommended approaches to reduce respondent burden is available here.