Approved Projects

This page lists the projects that form part of our first wave of pilot users for OpenSAFELY.

All projects are reviewed by NHS England to ensure they support relevant research and planning activities in response to the COVID-19 emergency; have a favourable ethical opinion (for research) or appropriate sensor sponsorship (for service evaluation or audit); and all users have signed up to the OpenSAFELY principles.

In this wave, pilot users need to have substantial computational data science skills, and strong experience of working with primary care electronic health record data.

An onboarding process flowchart is described here.


Project #1

We attempted to calculate the counts of eligible patients for the Covid vaccine based on the priorities set out in the Green Book and GOV advice for clinically extremely vulnerable.

The approach used primary care data mostly based on age and a list of high/moderate risk health conditions (without health care workers considered).

This work was conducted between October 2020 and January 2021. In January 2021 this analysis was superseded by the “SARS-CoV2 (COVID-19) Vaccine Uptake Reporting Specification” — opensafely/primis-covid-vacc-uptake-spec.

The work approved in this application is published here as a public record of analysis carried out on OpenSAFELY, but must not to be used for onward development, decision making or further analysis.

A vaccine uptake report has since been pre-printed doi.org/10.1101/2021.01.25.21250356


Project #2

An online consultation enables a patient to contact their GP, other health professional or GP practice staff over the internet, typically by using a smartphone, tablet or computer. This is a fairly new technology in terms of adoption, though its use had been accelerated by the pandemic. NHSE/I, through its Digital First Primary Care (DFPC) programme, has been working on enabling and stimulating the use of online consultation systems as a means to improve access to primary care and make best use of clinicians’ time.

OpenSAFELY was identified as a way of providing intelligence on online consultations activity prior and alongside the pandemic, particularly in the way events are recorded or not in primary care records via dedicated codes. In this initial discovery piece, we looked at:

  • understanding how certain online consultation-relevant codes of were used in terms of adoption and volume
  • understanding broad demographics and past clinical history of those associated with online consultation-relevant codes

These insights are being triangulated further with supplier data and qualitative findings as part of a wider research piece. Wider efforts on improving intelligence for operational, research and evaluation purposes are also underway.


Project #3

  • Type: Research (ongoing)

The aim of the study is to estimate the effectiveness of the vaccines for COVID-19 using the age thresholds in the JCVI COVID-19 vaccination first phase priority groups under a modelling approach known as a regression discontinuity design.

  • Study lead: Tom Palmer
  • Organisation: University of Bristol

Project #4

  • Type: Research (ongoing)

The effectiveness of COVID-19 vaccines against clinical outcomes: a test negative case control study using OpenSAFELY

Background

As soon as SARS-CoV2 was identified as the virus causing the ongoing COVID-19 pandemic, scientists and vaccine manufacturers worked rapidly to develop vaccines against it. Since late 2020, the UK has been rolling out a phased mass vaccination programme in the adult population, starting with people at greatest risk of severe infection. In clinical trials with volunteers, all three of the UK’s currently authorised vaccines were good at protecting recipients against infection but now that the vaccination programme is underway, it is important to look at how protective the vaccines are in the real world.

Aims of the study

  • To determine the type-specific vaccine effectiveness of individual deployed COVID-19 vaccines in preventing laboratory-confirmed SARS-CoV2 infection in specified subgroups of the population.
  • To determine the type-specific vaccine effectiveness of individual COVID-19 vaccines used to vaccinate the UK population in preventing hospitalisation due to COVID-19 related disease in specified subgroups of the population.

Methods

In this study we will evaluate how good each vaccine is at protecting people against infection with SARS-CoV2, and also at preventing serious outcomes of COVID-19 such as hospitalisation. We will use a test-negative case control design study to compare COVID-19 vaccination status in people with symptoms of COVID19 who have a positive SARS-CoV2 test (cases) with people who also have symptoms but who have a negative test (controls). Using this study design, we will also look at the vaccines' effectiveness in particular subgroups, such as the elderly and people with poorly functioning immune systems, to see if the vaccines work less well in some groups.

We will estimate the vaccines' effectiveness in preventing infection and serious outcomes at different time points after the first and second doses of the vaccine, and after a booster dose if this is recommended. Logistic regression will be used to determine adjusted type-specific vaccine effectiveness estimates and we will repeat analyses at intervals for up to 3 years after the start of the vaccine rollout to detect waning VE.

We will use a secure analytic platform, OpenSAFELY, to run analysis codes against approximately 24 million routinely collected electronic health records (EHRs) for adult patients who are registered at GP practices. This study will complement other studies using different data sources or study design, and will add to the body of knowledge to inform the government’s expert independent advisory body, the JCVI, when it make recommendations on future vaccination policy.


Project #5

  • Type: Service evaluation (ongoing)

The aim of this work is to assess NHS England guidance issued at the peak of the COVID pandemic recommending FIT (stool) testing for all patients suspected of colo-rectal cancer which could be undertaken in primary or secondary care. The extent to which this advice has been implemented across the system, particularly in primary care, is unknown, since routine operational reporting from pathology systems is not a mandatory requirement.

In addition FIT testing in patients aged <50 (who are at very low risk of colo-rectal cancer) may be adding to the demand for the cancer two week waits, Lower GI referrals and subsequent colonoscopy.

Analysis of the data will allow us to determine if particular variables (e.g. age, gender, ethnicity, locality, FIT level, etc.) are related to an increased risk of colo-rectal cancer diagnosis, and importantly, if patients can be categorised into a very low risk of colo-rectal cancer. NHS England would then ensure that these outputs were included in further guidance to support more appropriate and targeted referral for colonoscopy when investigating suspected colo-rectal cancer.

  • Study lead: Nick Kennedy
  • Organisation: Royal Devon & Exeter NHS Foundation Trust and University of Exeter

Project #6 and #7 (merged)

Type: Service Evaluation (under review)


Project #8

  • Type: Research

Recent research into coronavirus has shown that members of the public can play a crucial role in controlling infection outbreaks, by adopting simple behaviours to curb the spread of infection in the home such as handwashing, cleaning surfaces, wearing of face coverings and social distancing. Despite public health advice, evidence shows most people need to change their behaviour to help prevent infection.

Germ Defence is an interactive website employing behaviour change techniques to supplement public health advice. Germ Defence was originally developed during the H1N1 swine flu pandemic using theory, evidence and extensive feedback from members of the public. It was then trialled in over 20,000 patients and shown to reduce the number and severity of infections of users and members of their household. Germ Defence has recently been updated for the COVID-19 pandemic. The website aims to help users with pre-planning about effective isolation of an infected household member; personalised goal setting for increasing a range of infection control behaviours; changing the home environment to support new habits and problem solving to overcome barriers.

What is the aim of the project?

This project aims to examine the effects of randomising dissemination of the Germ Defence website via GP practices on rates of respiratory infection, including COVID-19 and seasonal flu.

What are we doing?

We will contact every GP practice in England and ask them to share the link to Germ Defence with their patients. Half of the practices will be randomly chosen and asked to immediately send out the Germ Defence link to their patients in the Autumn of 2020. These practices will be known as the intervention arm or immediate implementation group. The other half of the practices will be contacted to send out Germ Defence in March 2021 and will be known as the usual care arm or delayed implementation group. We will assess usage of the Germ Defence link from anonymous data produced by the website. We will then use anonymised national data that is collected as part of routine care to compare whether infection rates are lower in practices that sent Germ Defence information to their patients immediately, compared to those that didn’t send the information until later.


Project #9

  • Type: Research (ongoing)

This project will link ISARIC-4C and OpenSAFELY data in order to follow up hospitalised patients with COVID-19 following discharge. ISARIC-4C is a UK-wide consortium responsible for prospectively collecting data and biological samples from hospitalised patients with COVID-19.

The aims of the project are to investigate children and young people under the age of 19 years with covid-19 to:

  • Assess the feasibility of combining a detailed clinical dataset of patients hospitalised with SARS-CoV-2 (ISARIC-4C dataset) with wide-ranging primary care data (OpenSAFELY dataset)
  • Investigate risk factors for hospital admission and disease severity
  • Investigate outcomes for children hospitalised with covid-19 stratified by severity, compared to those cared for in the community
  • Study lead: Olivia Swann
  • Email: Pending
  • Organisation: ISARIC

Project #10

  • Type: Service Evaluation (withdrawn)

Concern raised by the national clinical director of cardiovascular disease (CVD) about inequalities in the prevalence of CVD. The purpose for requesting GP record data in OpenSAFELY is to monitor service use for CVD pathways, blood pressure tests taken, corresponding reading, and medical prescription across geographical deprivation and ethnic groups. These metrics will serve as potential indicators for access and outcomes (for people of different ethnicities/people living in areas with different levels of deprivation) in CVD related primary care activity. We will particularly be monitoring the variations in these indicators that occurred over the course of the COVID-19 pandemic and assessing the relative success or failure in recovering primary care services.

Aims

  • To better understand and be able to interpret disparities in access and outcomes related to CVD to narrow health inequalities in this area.
  • To use CVD and this analysis as a test case in the processes necessary for developing primary care recovery of services indicators with OpenSAFELY
  • Study lead: N/A
  • Organisation: NHS England and NHS Improvement

Project #11

  • Type: Service evaluation (ongoing)

We will assess the impact of COVID-19 on antidepressant prescribing; one of five medicine classes identified in the PHE Review which NHSE/I are prioritising and leading on. As described by the OpenSafely paper in the Lancet, addressing the effect that the pandemic has had on mental health is important and we will use primary care data to measure and mitigate the indirect health impacts of COVID-19 on the NHS.

We will investigate whether potential barriers to accessing mental health services over the course of the pandemic have led to specific (or a change in) indications driving the already increasing trend in antidepressant prescribing by observing:

  • the rate of new initiations of antidepressants
  • the discontinuation of antidepressants

We will investigate the the impact of COVID-19 on dependency forming medication use by age, gender, Index of Multiple Deprivation (IMD), ethnicity, region (and other system level geographical cuts)

  • Study lead: Nisha Rajendran
  • Organisation: NHS England and NHS Improvement

Project #12

  • Type: Research (ongoing)

COVID-19 infection may increase the chances of certain conditions, including strokes and heart attacks. We will study people alive on 1 January 2020 with a record in OpenSAFELY to investigate whether this is the case. Specifically, we will compare the number of people with COVID-19 infection who also have a record of one of these conditions against the number of people without COVID-19 infection who also have a record of one of these conditions. This will allow us to estimate how much COVID-19 infection increases the risk of these conditions. Our work may inform whether people with COVID-19 infection should be offered preventative treatments to protect against these conditions.


Project #13

  • Type: Research and service evaluation (ongoing)

We want to understand how many people are diagnosed with Long COVID in general practice, who is diagnosed with Long COVID, and how long after getting COVID-19 people are diagnosed with Long COVID. We will also find out how this changes over time; and how different comorbidities and other factors impact the above.

  • Study lead: Emma Mi
  • Organisation: NHS England and NHS Improvement

Project #14

  • Type: Service evaluation (ongoing)

The NHS Cancer Programme is working to identify more people with prostate cancer as part of the pandemic recovery. To aid that work, we would like to know:

  • What was the impact of the pandemic on the number of patients who received prostate-specific antigen (PSA) tests?
  • If there was an impact on PSA test undertaken, which patients did this affect (by patient characteristic, geography, symptoms at presentation)?
  • Was the change in the quantity of PSA tests undertaken followed by a corresponding drop in the number of patients receiving onwards tests and treatment for prostate cancer?

Project #15

  • Type: Service evaluation (ongoing)

We will investigate how the prescribing of groups of medicines used to treat the mental health of residents of care homes has changed over the COVID-19 period. Residents have been more socially isolated given restrictions on visits from family and friends and trips outside the care home setting. There have also been high rates of death in care homes due to COVID-19, which may have affected the mental health of surviving residents and staff.

Given rates of depression, anxiety and stress are considered to have increased in the general UK population over the COVID-19 pandemic, we are interested in looking at how the prescribing of anti-psychotic and anti-depressant medicines to residents in care homes has changed over the COVID-19 pandemic and relative to the general population.

  • Study lead: Greg Eydmann
  • Organisation: NHS England & NHS Improvement

Project #16

  • Type: Research and service evaluation (ongoing)

The Covid-19 pandemic has resulted in major changes in how and whether patients can consult their General Practitioner. This has an impact on how their common infections (such as sore throat or bladder) are being diagnosed and treated. The number of telephone or web appointments has increased and there are concerns, in addition to patients not consulting their GP, that more antibiotics may be given inappropriately as it is difficult to diagnose remotely.

Prior to Covid-19, improvements in antibiotic prescribing in primary care (also known as antibiotic stewardship) were a major priority for the NHS. This was related to increased rates of infections in which antibiotics no longer work (known as antibiotic resistance), often related to overuse of antibiotics.

This project will provide up-to-date information to antibiotic stewardship activities in primary care.

Specific aims are to evaluate

  • the impact of Covid-19 on the primary care treatment pathways for common infections
  • the effects on antibiotic prescribing
  • the effects of prior antibiotic exposure (types and extent) on severity of outcomes in Covid-19 infections (including during and after hospital admission)

Project #17

  • Type: Research (ongoing)

Since the outbreak of COVID-19 in the UK, primary care has changed quite dramatically, with many general practices restricting physical consultations and instead providing phone and video consultations. This has affected the monitoring and management of a range of long-term conditions and is of particular importance in people with diabetes who would ordinarily have their diabetes and associated comorbidities frequently monitored through diabetic reviews at their GP practice and at diabetes clinics within the NHS. It is not yet understood what impact the change in access to services has had on these patients in terms of their diabetes control, cardiovascular risk factors, diabetes-related complications, and mortality.

In previous work, we sought to compare the frequency of primary care interactions, services, monitoring, prescribing, and diagnoses before and after the start of the pandemic, with a view to quantifying the level of unmet need in this patient group and highlighting the anticipated backlog that primary care services would face as restrictions were gradually eased. In this proposed phase of the project, we aim to examine rates of hospitalisation, ICU admissions, diabetes-related complications and associated adverse events by combining data from primary and secondary care, and to investigate specific causes of mortality in people with diabetes.

  • Study lead: Matthew Carr
  • Organisation: University of Manchester

Project #18

  • Type: Audit (ongoing)

We need to know to what extent the actual treatment of people with ongoing symptoms of COVID-19 matches published NICE guidance. This corresponds to carrying out an audit. If differences are found, NICE could use the information either to improve the presentation of guidelines or improve its implementation work.

This study uses OpenSAFELY data to compare summarised information from GP records against NICE’s guidelines for long-term effects of COVID-19.