King's College London

Academic Institute

Healthcare Quality Improvement PartnershipNHS England

No

DARS-NIC-199726-F4V3C-v1.4

Aim and purpose of the application: The National Clinical Audit and Patient Outcomes Programme (NCAPOP) is a large programme of circa 35 projects consisting of National Clinical Audits and Confidential Enquiries. HQIP is commissioned by NHS England to commission and manage the NCAPOP. NHS England is a controller of the NCAPOP jointly with HQIP as together both organisations determine the purposes and means of processing. NHS England is responsible for determining which projects/topics are included as part of the NCAPOP. HQIP, as commissioner of the NCAPOP, is responsible for project specification development, procurement and extension activities, contract management and authorising data sharing requests. NHS England, as a funder of the NCAPOP, participates within specification development, procurement and project extension activities and authorises the publication of project outputs. NHS England is involved with developing the scope and purpose of the NCAPOP projects through participation within specification development activities and may authorise (as chair of the specification development meetings) the final project specifications. These specifications set out the purpose of the project, the patient groups and clinical services to evaluate and the types of data to collect. NHS England are a representative upon the HQIP Data access request group which authorises data sharing applications from third parties. HQIP commissioned the British Society for Rheumatology (BSR) to undertake the NEIAA as part of the National Clinical Audit and Patient Outcomes Programme (NCAPOP). The British Society for Rheumatology is the UK's leading specialist medical society for rheumatology and musculoskeletal professionals. The BSR subcontracted an academic unit at King's College Hospital NHS Foundation Trust (KCH) to carry out the data processing, including all analyses and linkage. The Healthcare Quality Improvement Partnership (HQIP) requires hospital episodes statistics (HES) and mortality data for use in the National Early Inflammatory Arthritis Audit (NEIAA). This audit will help to improve the quality of care for people living with inflammatory arthritis across England and Wales. The current contract period is 1 October 2017 – 30 September 2020, with a further planned two year extension. The aim is to improve the quality of care for people living with inflammatory arthritis by assessing the performance of rheumatology units against NICE Quality Standards. There is compelling evidence that early intensive treatment greatly improves the outcome of these disabling diseases, which predominantly affect people of working age. Early diagnosis and treatment is a cornerstone of Early Inflammatory Arthritis (EIA) management and is underpinned by NICE guidelines (CG79). The audit will assess EIA services and will collect prospective data including: • Waiting times; • Time to treatment; • Provision of education; • Collection of patient reported outcomes; • Clinical response. • What’s included: – NHS secondary care settings in England and Wales. • What’s excluded: – Children and children’s services – Primary care Legal Basis Justification: HQIP and NHS England both rely on the Article 6 (1) (e) legal basis under GDPR - 'processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller'. This is justified through commissioning arrangements which link back to NHS England and other national bodies with statutory responsibilities to improve quality of health care services. The linkage requested is necessary for the performance of a task carried out in the public interest; improving the quality of care for people living with inflammatory arthritis. HQIP rely on Article 9 (2) (i) as the legal basis for processing under GDPR - 'processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy'. This is justified as all projects aim to drive improvements in the quality and safety of care and to improve outcomes for patients. NHS England rely on Article 9(2)(h) of the GDPR as the legal basis for processing. 'Processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3'. NHS England are responsible for provision of health and social care, and management of systems and compliance. The data requested will help to achieve the aim identified in the following ways: (1) Deliver quality metrics to inform Care Quality Commission (CQC) regulation of providers. (2) Create a dataset to inform quality improvement activity. (3) Create a dataset for epidemiological and health service research. (4) Quantification of the burden of disease for patients and society. (5) Provide evidence for cost effective service delivery. (6) Provide aggregate department level performance data for the Getting It Right First Time (GIRFT) programme Data subjects: Data are collected from all patients in England and Wales over the age of 16 who are seen in rheumatology services with a suspected diagnosis of early inflammatory arthritis. Purpose of Request: The collected audit data will be linked with the HES Outpatient and HES Admitted Patient Care dataset. It will also be linked the patient episode database for Wales (PEDW), pending approval from the NHS Wales Informatics Service. This will enable ascertainment of joint replacements, unplanned hospitalisations, and death. These linkages will be repeated annually. Only pseudonymised data will be requested - identifiers will be removed and a study ID will replace the identifiers. There will also be linkage to the Civil Registration/Mortality data set to determine mortality outcomes. In addition data on the total number of patients diagnosed with rheumatoid arthritis in outpatients for each trust will be requested. Data linkage will enable estimation of variation in the following: (1) Treatment delay (outpatient referral dates, diagnostic imaging dates), (2) Clinical outcomes (adverse events/unplanned hospitalisation, joint replacement surgery, mortality), (3) Healthcare resource utilisation (outpatient activity in 12 months following diagnosis), (4) Case-mix adjustment, and (5) Allow an assessment of case ascertainment. All data requested from NHS Digital will be pseudonymised data, this will allow patient level linkage while maintaining patient confidentiality. Linkage is requested for the duration of the contract of the project, and for all Trusts in England as NEIAA is a national project. There are no alternative less intrusive methods to achieve the above purpose of linkage. Data linkage will be reviewed on an annual basis to assess if the degree of data requested can be minimised. The data processing under this agreement is not in support of a specific PhD/post graduate research study, but may be utilised for future work, in the future. An amendment to this agreement or separate data sharing agreement will be formulated and submitted to NHS Digital for approval for this in the future if necessary. *** April 2020 - Ongoing COVID-19 Emergency: Request Within NEIAA the team have captured information on a large cohort of patients with rheumatoid, some of whom are on hydroxychloroquine. As per current news there is a lot of interest in whether hydroxychloroquine has anti-COVID effects. As part of the ongoing audit work, and in line with the national COVID-19 emergency, The NEIAA team seek to undertake analysis of the dataset to answer two questions of immediate public health importance: 1. What is the incidence of hospitalised COVID19 infection amongst patients with rheumatoid arthritis? 2. Does use of Hydroxychloroquine associate with a reduced risk of hospitalised COVID19? Hydroxychloroquine is used to prevent and treat acute attacks of malaria. It is also used to treat rheumatoid arthritis in patients whose symptoms have not improved with other treatments. Hydroxychloroquine is in a class of drugs called antimalarials. It works by killing the organisms that cause malaria. Hydroxychloroquine may work to treat rheumatoid arthritis by decreasing the activity of the immune system Background SARS-CoV2 appeared as a novel virus in China in late 2019. The virus causes the clinical syndrome COVID19. Most people affected by COVID19 have a mild illness, however a significant minority experience a severe respiratory disease with high mortality. Preventing severe disease 1. Avoid exposure for high-risk individuals Risk factors for severe disease are under investigation. Pending further understanding, recommendations have been published recommending all patients with chronic health conditions (specifically including people with rheumatoid arthritis on immune suppression) to actively shield themselves from the virus. Shielding has significant implications both personally and societally. Given the potential extended duration of the pandemic, better understanding of the need for shielding is urgently needed. 2. Prophylactic medication To date no therapy has been proven to be effective either in the prevention or treatment of COVID19. Many studies are under way exploring therapeutic options, although studies on prophylaxis are lacking. Since the outset of the pandemic, Hydroxychloroquine has been an agent of interest due to potential antiviral and immune modulatory effects. However, there are parallel concerns about toxicity of the drug (especially cardiac complications). Equipoise about its use is still present. NEIAA has collected data on over 12,000 individuals with a newly diagnosed inflammatory arthritis since May 2018. Over 2,500 of these people started on hydroxychloroquine as part of their standard treatment. The dataset has potential to offer insight into the two questions outlined above. Datasets 1. NEIAA dataset (all patients enrolled in audit from May 2018 until present) 2. NHS Digital linked HES outcomes (data on unplanned hospital admissions) 3. NWIS linked HES outcomes (data on unplanned hospital admissions) Statistical analysis plan Incidence of admitted COVID19 in Rheumatoid Arthritis patients Event rates (with 95% confidence intervals) will be calculated per 1000. Population comparisons will be made using standardised incidence ratios comparing to publicly available data. Protective effect of hydroxychloroquine The odds of being admitted for COVID19 will be compared between hydroxychloroquine users and non-users using logistic regression. Estimates will be compared with adjustment for age, gender, ethnicity, and comorbidity (all known predictors of COVID19 admission). Sensitivity analyses will use propensity score matching to further evaluate the effects of confounding.

There are already clear signs since the launch of NEIAA that that it is helping to improve the quality of care for patients with EIA across England and Wales. Specific evidence of public benefit that has helped been achieved with the use of the NHS Digital data includes the following: • Publication of the first annual report, including a patient and public report. • Use of NEIAA data in Getting It Right First Time (GIRFT) reviews of rheumatology services in England • Collaboration with the Care Quality Commission (CQC) to develop 4 core provider-level metrics from the audit for inclusion in CQC reviews • Development of the Best Practice Tariff (BPT) in England, linked to audit data, to incentivise good quality care • Improvement in key metrics of EIA care- review time and treatment time • Evidence from trusts and health boards of improvements driven by NEIAA, including action plans, creation of new posts, introduction of additional/dedicated EIA clinics, changes in referral triage processes, and GP education initiatives. • Commendation in the HQIP Richard Driscoll Memorial Award for outstanding progress in demonstrating robust and sustained patient involvement in developing clinical audit and in reporting outcomes for patients through the programme.

05/05/2020

Personally Identifiable

Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii)

Section 251 NHS Act 2006

Recurring

TRE