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Table 1 Characteristics of individual studies

From: Systematic review of guidance for the collection and use of patient-reported outcomes in real-world evidence generation to support regulation, reimbursement and health policy

Author

Year

Issuer

Publication type

Patient population

Context for PRO usage

Aim of the publication

Scope of the publication

Hanson et al. [34]

2020

Division of Geriatric Medicine, University of North Carolina

Journal article

People with Dementia

Pragmatic Clinical Trials

To promote optimal use of outcomes relevant to people leaving with dementia and their caregivers in pragmatic trials

PCRO Core was proposed to promote optimal use of outcomes relevant to PLWD and their caregivers in pragmatic trials

Calvert et al. [6]

2019

CPROR, University of Birmingham

Comment

General

Drug development

To describe key challenges for use of PROs as part of RWE by payers and regulators

Overview of challenges in collecting, analysing, and integrating PRO data with other forms of RWE. Putting forward strategic priorities to help address these challenges

Rylands et al. [37]

2018

pH Associates (an OPEN Health company)

Conference poster

General

Research (various designs using RWD)

To summarise the key considerations for researchers collecting PRO data in RW studies

Summary of the key considerations for PRO data collection. Authors postulate the creation of a specific set of guidelines

Kyte et al. [35]

2016

CPROR, University of Birmingham

Journal article

Patients undergoing varicose vein, groin hernia and hip replacement surgery

Post-authorisation safety studies

To evaluate NHS PROMs programme for routine PRO data collection

Pointing areas for improvement in routinely collected PROs within NHS

Akiyama et al. [38]

2015

Bayer Yakuhin, Ltd

Conference poster

Elderly patients

Post-authorisation safety studies

To describe challenges and propose best practices for conducting post-marketing surveillance PRO surveys among elderly patients

A brief overview of challenges in collecting and using PRO data from elderly patients as part of post-marketing surveillance. Proposing best practices to help address these challenges

Banerjee et al. [36]

2013

PROSPER Consortium

Journal article

General

Safety reporting

To develop guidance on PRO-AE data, including the benefits of wider use and approaches for data capture and analysis. To support the wider use of PROs in safety reporting (pharmacovigilance)

Providing PRO-AEs taxonomy, suggesting a range of datasets that could be used for safety reporting, data collection mechanisms and analytical methodologies. Minimum core dataset for use by industry or regulators to structure PRO-AEs was proposed

ABPI [39]

2011

ABPI

Report

General

Research (various designs using RWD)

To provide further clarity around the definitions, use and practical issues which arise when undertaking RWD projects

Presentation of terminology related to RW studies. Methodological recommendations for RWD generation to be used for research, audit, and service evaluation purposes

  1. ABPI The Association of the British Pharmaceutical Industry; CPROR Centre for Patient Reported Outcome Research; NHS National Health Service; PCRO patient- and caregiver-reported outcomes; PLWD people living with dementia; PRO patient-reported outcome; PROM patient-reported outcome measure; RW real-world; RWD real-world data; RWE real-world evidence