Misconceiving patient reported outcome measures (PROMs) as primarily a reporting requirement rather than a quality improvement tool: perceptions of independent healthcare sector stakeholders in the UK.

BACKGROUND: The independent healthcare sector in the UK collects PROMs for several surgical procedures, but implementation has been challenging. We aimed to understand the enablers and barriers to PROMs implementation in the independent healthcare sector in the UK. METHOD: Between January and May 2021, we remotely conducted semi-structured interviews with hospital consultants, hospital managers and other clinical staff using a topic guide developed from an implementation science framework called the Theoretical Domains Framework (TDF). RESULTS: We interviewed 6 hospital consultants, 5 hospital managers, and 3 other clinical staff (1 nurse and 2 physiotherapists) across 8 hospitals. Common barriers included: the perception that PROMs are predominantly a reporting requirement rather than a quality improvement tool, absence of feedback mechanisms for PROMs data for clinicians, poor awareness of PROMs among healthcare professionals and the public, absence of direction or commitment from leadership, and limited support from hospital consultants. Common enablers included: regular feedback of PROMs data to clinicians, designating roles and responsibilities, formally embedding PROMs collection into patient pathways, and involvement of hospital consultants in developing strategies to improve PROMs uptake. CONCLUSION: To support PROMs implementation, independent hospitals need to develop long-term organisational strategies that involve sustained leadership commitment, goals or targets, training opportunities to staff, and regular feedback of PROMs data at clinical or governance meetings. The primary purpose of PROMs needs to be reframed to independent healthcare sector stakeholders as a quality improvement tool rather than a reporting requirement.

Emergency contracting and the delivery of elective care services across the English National Health Service and independent sector during COVID-19: a descriptive analysis.

BACKGROUND: Following a virtual standstill in the delivery of elective procedures in England, a national block contract between the NHS and the independent sector aimed to help restart surgical care. This study aims to describe subsequent changes in trends in elective care service delivery following implementation of the initial iteration of this contract. METHODS: Population-based retrospective cohort study, assessing the delivery of all publicly funded and privately funded elective care delivered in England between 1 April 2020 and 31 July 2020 compared with the same period in 2019. Discharge data from the Hospital Episode Statistics and private healthcare data from the Private Health Information Network was stratified by specialty, procedure, length of stay and patient complexity in terms of age and Charlson Comorbidity Index. RESULTS: COVID-19 significantly reduced publicly funded elective care activity, though changes were more pronounced in the independent sector (-65.1%) compared with the NHS (-52.7%), whereas reductions in privately funded elective care activity were similar in both independent sector hospitals (-74.2%) and NHS hospitals (-72.9%). Patient complexity increased in the independent sector compared with the previous year, with mixed findings in NHS hospitals. Most specialties, irrespective of sector or funding mechanisms, experienced a reduction in hospital admissions. However, some specialities, including medical oncology, clinical oncology, clinical haematology and cardiology, experienced an increase in publicly-funded elective care activity in the independent sector. CONCLUSION: Elective care delivered by the independent sector remained significantly below historic levels, although this overlooks significant variation between regions and specialities. There may be opportunities to learn from regions which achieved more significant increases in publicly funded elective care in independent sector providers as a strategy to address the growing backlog of elective care.

A data flow process for confidential data and its application in a health research project.

BACKGROUND: The use of linked healthcare data in research has the potential to make major contributions to knowledge generation and service improvement. However, using healthcare data for secondary purposes raises legal and ethical concerns relating to confidentiality, privacy and data protection rights. Using a linkage and anonymisation approach that processes data lawfully and in line with ethical best practice to create an anonymous (non-personal) dataset can address these concerns, yet there is no set approach for defining all of the steps involved in such data flow end-to-end. We aimed to define such an approach with clear steps for dataset creation, and to describe its utilisation in a case study linking healthcare data. METHODS: We developed a data flow protocol that generates pseudonymous datasets that can be reversibly linked, or irreversibly linked to form an anonymous research dataset. It was designed and implemented by the Comprehensive Patient Records (CPR) study in Leeds, UK. RESULTS: We defined a clear approach that received ethico-legal approval for use in creating an anonymous research dataset. Our approach used individual-level linkage through a mechanism that is not computer-intensive and was rendered irreversible to both data providers and processors. We successfully applied it in the CPR study to hospital and general practice and community electronic health record data from two providers, along with patient reported outcomes, for 365,193 patients. The resultant anonymous research dataset is available via DATA-CAN, the Health Data Research Hub for Cancer in the UK. CONCLUSIONS: Through ethical, legal and academic review, we believe that we contribute a defined approach that represents a framework that exceeds current minimum standards for effective pseudonymisation and anonymisation. This paper describes our methods and provides supporting information to facilitate the use of this approach in research.

Networked information technologies and patient safety: a protocol for a realist synthesis.

BACKGROUND: There is a widespread belief that information technologies will improve diagnosis, treatment and care. Evidence about their effectiveness in health care is, however, mixed. It is not clear why this is the case, given the remarkable advances in hardware and software over the last 20 years. This review focuses on interoperable information technologies, which governments are currently advocating and funding. These link organisations across a health economy, with a view to enabling health and care professionals to coordinate their work with one another and to access patient data wherever it is stored. Given the mixed evidence about information technologies in general, and current policies and funding, there is a need to establish the value of investments in this class of system. The aim of this review is to establish how, why and in what circumstances interoperable systems affect patient safety. METHODS: A realist synthesis will be undertaken, to understand how and why inter-organisational systems reduce patients' clinical risks, or fail to do so. The review will follow the steps in most published realist syntheses, including (1) clarifying the scope of the review and identifying candidate programme and mid-range theories to evaluate, (2) searching for evidence, (3) appraising primary studies in terms of their rigour and relevance and extracting evidence, (4) synthesising evidence, (5) identifying recommendations, based on assessment of the extent to which findings can be generalised to other settings. DISCUSSION: The findings of this realist synthesis will shed light on how and why an important class of systems, that span organisations in a health economy, will contribute to changes in patients' clinical risks. We anticipate that the findings will be generalizable, in two ways. First, a refined mid-range theory will contribute to our understanding of the underlying mechanisms that, for a range of information technologies, lead to changes in clinical practices and hence patients' risks (or not). Second, many governments are funding and implementing cross-organisational IT networks. The findings can inform policies on their design and implementation. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42017073004.

Authority and the Future of Consent in Population-Level Biomedical Research.

Population-level biomedical research has become crucial to the health system's ability to improve the health of the population. This form of research raises a number of well-documented ethical concerns, perhaps the most significant of which is the inability of the researcher to obtain fully informed specific consent from participants. Two proposed technical solutions to this problem of consent in large-scale biomedical research that have become increasingly popular are meta-consent and dynamic consent. We critically examine the ethical and practical credentials of these proposals and find them lacking. We suggest that the consent problem is not solved by adopting a technology driven approach grounded in a notion of 'specific' consent but by taking seriously the role of research governance in combination with broader conceptions of consent. In our view, these approaches misconstrue the rightful location of authority in the way in which population-level biomedical research activities are structured and organized. We conclude by showing how and why the authority for determining the nature and shape of choice making about participation ought not to lie with individual participants, but rather with the researchers and the research governance process, and that this necessarily leads to the endorsement of a fully articulated broad consent approach.

Data Safe Havens in health research and healthcare.

MOTIVATION: The data that put the 'evidence' into 'evidence-based medicine' are central to developments in public health, primary and hospital care. A fundamental challenge is to site such data in repositories that can easily be accessed under appropriate technical and governance controls which are effectively audited and are viewed as trustworthy by diverse stakeholders. This demands socio-technical solutions that may easily become enmeshed in protracted debate and controversy as they encounter the norms, values, expectations and concerns of diverse stakeholders. In this context, the development of what are called 'Data Safe Havens' has been crucial. Unfortunately, the origins and evolution of the term have led to a range of different definitions being assumed by different groups. There is, however, an intuitively meaningful interpretation that is often assumed by those who have not previously encountered the term: a repository in which useful but potentially sensitive data may be kept securely under governance and informatics systems that are fit-for-purpose and appropriately tailored to the nature of the data being maintained, and may be accessed and utilized by legitimate users undertaking work and research contributing to biomedicine, health and/or to ongoing development of healthcare systems. RESULTS: This review explores a fundamental question: 'what are the specific criteria that ought reasonably to be met by a data repository if it is to be seen as consistent with this interpretation and viewed as worthy of being accorded the status of 'Data Safe Haven' by key stakeholders'? We propose 12 such criteria. CONTACT: paul.burton@bristol.ac.uk.