Self-reported and routinely collected electronic healthcare resource-use data for trial-based economic evaluations: the current state of play in England and considerations for the future

Matthew Franklin,Joanna Thorn

doi:10.1186/s12874-018-0649-9

Matthew Franklin, Joanna Thorn

Open Access

https://doi.org/10.1186/s12874-018-0649-9

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Abstract

BackgroundRandomised controlled trials (RCTs) are generally regarded as the “gold standard” for providing quantifiable evidence around the effectiveness and cost-effectiveness of new healthcare technologies. In order to perform the economic evaluations associated with RCTs, there is a need for accessible and good quality resource-use data; for the purpose of discussion here, data that best reflect the care received.Traditionally, researchers have developed questionnaires for resource-use data collection. However, the evolution of routinely collected electronic data within care services provides new opportunities for collecting data without burdening patients or caregivers (e.g. clinicians). This paper describes the potential strengths and limitations of each data collection method and then discusses aspects for consideration before choosing which method to use.Main textWe describe electronic data sources (large observational datasets, commissioning data, and raw data extraction) that may be suitable data sources for informing clinical trials and the current status of self-reported instruments for measuring resource-use. We assess the methodological risks and benefits, and compare the two methodologies. We focus on healthcare resource-use; however, many of the considerations have relevance to clinical questions.Patient self-report forms a pragmatic and cheap method that is largely under the control of the researcher. However, there are known issues with the validity of the data collected, loss to follow-up may be high, and questionnaires suffer from missing data. Routinely collected electronic data may be more accurate and more practical if large numbers of patients are involved. However, datasets often incur a cost and researchers are bound by the time for data approval and extraction by the data holders.ConclusionsOwing to the issues associated with electronic datasets, self-reported methods may currently be the preferred option. However, electronic hospital data are relatively more accessible, informative, standardised, and reliable. Therefore in trials where secondary care constitutes a major driver of patient care, detailed electronic data may be considered superior to self-reported methods; with the caveat of requiring data sharing agreements with third party providers and potentially time-consuming extraction periods. Self-reported methods will still be required when a ‘societal’ perspective (e.g. quantifying informal care) is desirable for the intended analysis.

Highlights

We describe electronic data sources that may be suitable data sources for informing clinical trials and the current status of self-reported instruments for measuring resource-use
CH Ridyard and DA Hughes [4] conducted a systematic review of studies funded by the United Kingdom (UK) Health Technology Assessment (HTA) program to identify the different methods used for the collection of resource-use data within clinical trials; the majority of studies identified (61 of 85) used at least two methods, typically involving patient- or carer-completed forms and medical records, the latter of which is referred to as ‘routinely collected care data’ within this manuscript
This paper focuses on person-level data for consenting people, so it is worth noting that self-reported and electronic data are governed by stringent information governance (IG) and data protection policies and regulations such as the General Data Protection Regulation (GDPR), which often requires de-identification of person-level data before it can be used for research purposes

Summary

Introduction

We describe electronic data sources (large observational datasets, commissioning data, and raw data extraction) that may be suitable data sources for informing clinical trials and the current status of self-reported instruments for measuring resource-use. The aim of this paper is to compare the two aforementioned methods for collecting resource-use information for trial-based economic evaluations: (1) self-reported methods, whereby ‘self-report’ is by the patient about their own resource-use; (2) methods for using routinely collected resource-use data from electronic sources such as electronic versions of medical notes on administrative systems and large healthcare databases, which can contain information about individuals and cohorts of patients. We focus mainly on the acquisition of healthcare resource-use data (e.g. use of inpatient hospital care and seeing a nurse in a GP practice or home setting) rather than clinical outcome data (e.g. hospital anxiety and depression scale scores) as the focus here is on data normally used for the purpose of economic evaluation; many of the considerations described have relevance to other forms of clinical and health-related data which may be routinely collected and/or patient-reported. It should be noted that there are objectively measured outcomes and investigator-reported data, which may be routinely collected and used for clinical trials, are outside of the scope of this paper as these methods are rarely used to collect resource-use data

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