Table 1.

Characteristics of individual studies

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

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