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.
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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
- ISO 14155:2026 Clinical investigation of medical devices for human subjects – Good clinical practice
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.
- Data Monitoring and Clinical Response: It is important for protocols to specify if and how PRO data will be monitored in real-time. If a digital PRO indicates a high risk (e.g., suicidal ideation), there must be a clear, response plan. As part of a research study, such a response plan should form part of the ethics submission for approval.
- Equity and Inclusion: It is important for digital tools and PRO assessment to be accessible and that they address the diverse needs of the target population. Ethical design includes involving service users with lived experience in the selection and implementation of PROs. More information on this is available here and this can be considered as part of an Inclusion and Diversity Plan.
- Data access and Security
Users should be informed of who will be accessing their PRO data and for what purpose, such as:
- to directly inform their care or be viewed by a clinician
- or primarily for use in research and evidence generation.
4. Usability Testing of PRO systems
Methodological considerations for usability testing are available here and some recommendations for the validation of electronic PRO systems are available here.
5. Clinical study Protocol Design and Reporting
High-quality PRO data require rigorous study design and transparent reporting. Therefore, it is important to define clearly the target estimands in order to ensure that the trial design, data collection and analysis method are aligned with the PRO objectives. The PROTEUS Consortium recommends the following international standards:
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SPIRIT-PRO Extension: This 16-item checklist provides a standard for clinical study protocols where PROs are primary or key secondary outcomes. Developers should clearly define:
- Rationale & Objectives: State the PRO-specific research question and specific domains / hypotheses being measured (e.g. mood, social function, health status).
- Eligibility & Instruments: Specify PRO-specific inclusion criteria (e.g. language requirements) and justify the selection and measurement properties of the chosen PRO instruments.
- Assessment Schedule: Provide a clear timeline for data collection, including a rationale for collection time points to minimize participant burden yet demonstrate interventional performance.
- Data Management: Outline the data collection plan, including translations, proxy completion rules, and specific strategies to minimize missing data.
- Clinical Monitoring: State whether PRO data will be monitored during the study to inform the clinical care of individual participants.
- CONSORT-PRO Extension: This guidance can help support the transparent reporting of DMHT clinical studies including PROs as a primary or key secondary outcome. It requires reporting the PRO results in the context of their clinical significance and limitations, such as missing data and generalizability of the results to the target population.
6. Implementation of DMHTs including PRO interventions in Routine Clinical Practice
The PROTEUS-Practice guidance supports the use of PROs in routine care: Design, Implementation, and System & Data Management.
This guidance shares that DMHTs, including PROs, should consider:
- Actionable and Integrated Design: Design interfaces so PRO data is reliable, relevant, and interpretable for both users and clinicians.
- Protocol-Driven Clinical Response: Establish clear pathways for responding to PRO data. If a technology indicates high risk (e.g., severe symptoms), a standardised response plan must be in place.
- Transparency and Data Governance: Clearly communicate how PRO data will be used, stored, and accessed.
- Equity and Inclusion: Ensure PRO tools are accessible and address the diverse needs of the target population.
7. Adverse Event Reporting:
If a DMHT, including PROs, is used in a clinical study as part of a clinical investigation, there are adverse event reporting obligations to the MHRA. For more information, please see here.
If a DMHT, including PROs, qualify as SaMD and are being used on the market, safety concerns or events that caused harm or distress can be reported to the MHRA Yellow Card scheme.
Adverse events can be challenging to identify in DMHT studies and real-world use. A worsening of PRO scores may be indicative and it is important for investigators / manufacturers to be vigilant for this.
8. Additional resources
Disclaimer
The resources and papers listed on this page are compiled for information and operational support. While recommended for practical use, these documents do not constitute formal regulatory policy, guidance, or statutory instructions approved by the MHRA or the National Institute for Health and Care Excellence. Users should exercise professional judgement when applying these resources to their specific context.