Table 2 Checklist of consensus-based considerations for use of proxies and proxy-reported measures and reporting recommendations

Study design

Plan and justify the use of a proxy respondent, including specifying when a proxy is needed and allowed

SPIRIT-PRO [26, 27]; NQF [19, 18]

Provide evidence of the psychometric properties of the proxy assessment tool

SPIRIT-PRO [26, 27]; MORECare [29]

Specify the criteria for choosing who can act as a proxy (e.g., based on contact/closeness with the patient)

Montreal Accord [25];

ISOQOL user guide [11]

For longitudinal studies, plan for the same proxy to respond across all time points

Neuro-QoL [48]

Specify what domains a proxy can report on, and whether judgements can be made

PCORI minimum standards [16]; Montreal Accord [25]; MORECare [29]; FDA [3]

Data Collection Methods

Describe how the proxy should respond (proxy- or patient-perspective)

ISOQOL user guide [11]

Clear instructions for the proxy should be listed prior to the question

Neuro-QoL [48]; DEMQOL [39]

Analytic methods

Describe and justify whether and when patient-reported data might be replaced by proxy-reported data

EMA [2]

Consider risk adjustment for proxy completion

NQF [19, 18]

Consider sensitivity analyses to assess the potential impact of proxy-reported data on interpretation of estimates

SPIRIT-PRO [27]

Outcomes Interpretation

Consider whether the same proxy responded across all domains and time points

Neuro-QoL [48]

Consider how proxy responses affect score interpretation and study results

CMS [15]; CONSORT PRO [28]; DEMQOL [40]

Reporting recommendations

Report on considerations above, including:

Summarize who completed the proxy reports, and what proxies reported on

Describe specific instructions and perspective(s) used

Detail any analytic methods for interpreting results from proxies

MORECare [29]; AHRQ [52]; ISOQOL user guide [11]

Differentiate patients and proxies in the results

MORECare [29]; CONSORT PRO [28]

Describe how proxy responses may have affected results

CMS [15]; CONSORT PRO [28]; DEMQOL [40]