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Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life endpoints

Setting International Standards in Analyzing

Patient-Reported Outcomes and Quality of Life

endpoints

Publication library

Publication library

What does this webtool do?

What does this webtool do?

This interactive webtool helps you choose an appropriate PRO analysis method based on a well-defined PRO objective. The tool will display recommended appropriate statistical method based on your answers to three short questions.

The webtool is based on the SISAQOL consensus recommendations (2020). You can find the link to the SISAQOL consensus recommendations pre-print here.

This interactive webtool helps you choose an appropriate PRO analysis method based on a well-defined PRO objective. The tool will display recommended appropriate statistical method based on your answers to three short questions.

The webtool is based on the SISAQOL consensus recommendations (2020). You can find the link to the SISAQOL consensus recommendations pre-print here.

This tool does not give guidance on selection of:

  • PRO instrument
  • PRO domain(s) of interest
  • Thresholds for clinical relevance
  • Time point and time frame of interest

We make the assumption that you have already selected/identified the elements above.

This tool does not give guidance on selection of:

  • PRO instrument
  • PRO domain(s) of interest
  • Thresholds for clinical relevance
  • Time point and time frame of interest

We make the assumption that you have already selected/identified the elements above.

How were these methods recommended?

How were these methods recommended?

For each PRO objective, statistical methods were recommended on the basis of an agreed set of selection criteria. If a statistical method did not satisfy an essential criterion, then the method was not recommended as appropriate for PRO analysis.

Essential statistical features (2):

  • Ability to do a statistical test between two treatment groups
  • Ability to produce clinically relevant results

Highly desirable statistical features (3):

  • Ability to adjust for covariates, including baseline PRO score
  • Ability to handle missing data with the least restrictions
  • Ability to handle clustered data (repeated assessments)

For each PRO objective, statistical methods were recommended on the basis of an agreed set of selection criteria. If a statistical method did not satisfy an essential criterion, then the method was not recommended as appropriate for PRO analysis.

Essential statistical features (2):

  • Ability to do a statistical test between two treatment groups
  • Ability to produce clinically relevant results

Highly desirable statistical features (3):

  • Ability to adjust for covariates, including baseline PRO score
  • Ability to handle missing data with the least restrictions
  • Ability to handle clustered data (repeated assessments)

Interactive webtool

Interactive webtool

Q1: Please specify the within-treatment group PRO assumption for the treatment/control arm





Q2:Please specify the within-patient/within-treatment PRO objective of interest

A: Time to improvement

B: Proportion of patients with improvement at time t

C: Magnitude of improvement at time t

Q2:Please specify the within-patient/within-treatment PRO objective of interest

A: Time to (end of) stable state

B: Proportion of patients with stable state at time t

C: Magnitude of stable state at time t

Q2:Please specify the within-patient/within-treatment PRO objective of interest

A: Time to worsening

B: Proportion of patients with worsening at time t

C: Magnitude of worsening at time t

Q2:Please specify the within-patient/within-treatment PRO objective of interest

A: Overall PRO score over time

B: Response patterns/profiles

Q3:Please specify whether the broad PRO research objective is confirmatory (+ the between-treatment arms objective) or exploratory/descriptive


B: Confirmatory objective: Equivalence/non-inferiority

C: Describe patient perspective (Exploratory/descriptive)

Do you have comments on our recommendations or suggestions to improve this webtool? Please do not hesitate to contact us via the contact button below.

Do you have comments on our recommendations or suggestions to improve this webtool? Please do not hesitate to contact us via the contact button below.