2015 User’s Guide to Implementing Patient-Reported Outcomes Assessment in Clinical Practice (Version 2)
2015 User’s Guide (Version 2)- Japanese Translation
2018 Companion Guide to the ISOQOL 2015 User’s Guide (Version 2)

Review of 2011 User’s Guide (Version 1)

Response to FDA Patient-Focused Drug Development Guidance 4—Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making

Response to FDA Patient-Focused Drug Development Guidance 3—Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments

Response to FDA Patient-Focused Drug Development Guidance 2—Methods to Identify What Is Important to Patients

Response to FDA Standard Core Clinical Outcome Assessments and Endpoints Notice

Response to EMA Draft reflection paper on the use of patient reported outcome (PRO) measures in oncology studies

To learn more about ISOQOL endorsements, visit Who We Are to read the Publication Authorship & Endorsement policy in the ISOQOL Policy Manual.

2021

Using an implementation science approach to implement and evaluate patient-reported outcome measures (PROM) initiatives in routine care settings

Prospective application of implementation science theories and frameworks to inform use of PROMs in routine clinical care within an integrated pain network

The utility of the implementation science framework “Integrated Promoting Action on Research Implementation in Health Services” (i-PARIHS) and the facilitator role for introducing patient-reported outcome measures (PROMs) in a medical oncology outpatient department

A retrospective assessment of the KLIK PROM portal implementation using the Consolidated Framework for Implementation Research (CFIR)

Using implementation science to inform the integration of electronic patient-reported experience measures (ePREMs) into healthcare quality improvement: description of a theory-based application in primary care (Subscription)

2020 

Good practices for the translation, cultural adaptation, and linguistic validation of clinician-reported outcome, observer-reported outcome, and performance outcome measures

2019

Comparison of Psychometric Approaches to Evaluating the PROMIS Depression Instrument (A collection of papers)

Trials with proxy-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR) (Subscription)

2018

Reflection paper on copyright, patient-reported outcome instruments and their translations

Trials with patient-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR) (Subscription)

Emerging good practices for Translatability Assessment (TA) of Patient-Reported Outcome (PRO) measures

Towards the use of mixed methods inquiry as best practice in health outcomes research

2015

Pooling of cross-cultural PRO data in multinational clinical trials: How much can poor measurement affect statistical power? (Subscription)

2013

Methods for interpreting change over time in patient-reported outcome measures (Subscription)

ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research (Subscription)

2012

The Use of Patient-reported Outcomes (PRO) Within Comparative Effectiveness Research

General

• ICH Efficacy Guidelines
• Demystifying the estimand framework: a case study using patient-reported outcomes in oncology (Subscription)
• Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension
• COMET Initiative

EMA-related to COA

• Reflection Paper on the Regulatory Guidance for the Use of Health-Related Quality of Life (HRQL) Measures in the Evaluation of Medicinal Products
• Integrating patients’ views in clinical studies of anticancer medicines

FDA

• Clinical Outcome Assessments (COAs) in Medical Device Decision Making
• Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (Guidance for Industry)
• Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making

Collaborations with ISOQOL

• Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: the SPIRIT-PRO extension
• International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: recommendations of the SISAQOL Consortium (Subscription)
• The PROTEUS Consortium to advance the use of PROs in research studies and clinical care
• A Standard Set of Value-Based Patient-Centered Outcomes and Measures of Overall Health in Adults

2014

Webinar Series: Best Practices for Integrating Patient-Reported Outcomes in Oncology Clinical Trials
A Collaboration project between NCI and ISOQOL

• How to report PRO study findings from clinical trials
• How to develop the statistical plan and sample size calculation for the PRO component of a clinical study
• How to design a high quality study with PRO endpoints
• How to select the appropriate PRO measure
• How to identify the PRO context for clinical trials and identify the relevant PRO domains
• How to assure data quality for PROs in oncology clinical trials

2013

Symptom Management & Quality of Life Concept Design
A Collaboration project between NCI and ISOQOL