Cohorts and datasets Delivering innovative research through effective partnerships

Collaboration for Leadership in Applied Health Research and Care Yorkshire and Humber

Welcome to the NIHR CLAHRC YH Cohorts and Datasets Briefing paper We believe innovative methods allow NIHR CLAHRC YH to be at the forefront of creating new understanding and affording new opportunities to the people of Yorkshire and Humber. One such innovative method is the use of Cohorts and Big Data to drive new ways of researching and new evidence to improve the health and wealth of the people of Yorkshire and Humber. Through recruiting patients, to share data about their experience and medical conditions, into cohorts, we can allow other researchers to quickly identify and test out new treatments/interventions without having to start the recruitment process from scratch. The use of big data allows us to identify patterns at scale, ones which would not be visible through traditional methods. We can look at how people travel through a whole health care journey rather than a single piece of the jigsaw giving new insights to those who plan as well as deliver health care. We hope you find the following examples from our teams useful. Please get in touch with the named contacts if you would like to know more about them or would like to know how to access these innovative research platforms.

Glossary Cohort: Cohort studies are a type of medical research used to investigate the causes of disease, establishing links between risk factors and health outcomes. Cohort studies are usually forward-looking - that is, they are ‘prospective’ studies, or planned and carried out over a future period. Dataset: A collection of related sets of information that is composed of separate elements but can be manipulated as a unit by a computer. Trials within cohorts (TwiCs): ‘TwiCs’ stands for ‘Trials within Cohorts’. The ‘cohort multiple randomised controlled trial’ is one approach to the design and conduct of pragmatic trials within cohorts. Key features of the design are: • During consent to the cohort, participants optionally consent to be contacted about additional studies and for data linkage. • Recruitment of a large observational cohort of patients with the condition of interest • Regular measurement of outcomes for the whole cohort • Capacity for multiple randomised controlled trials over time There is a theoretical paper which outlines the new ‘cohort multiple randomised controlled trial’ design, which could help address the problems associated with existing approaches www.bmj.com/content/340/bmj.c1066

1

Collaboration for Leadership in Applied Health Research and Care Yorkshire and Humber

ADHD Cohort within our Telehealth and Care Technologies Theme The Health Tracker® (HT) project aims to implement the use of a computer database with children/adolescents diagnosed with ADHD. This includes their families, their teachers and the health professionals involved in their care in Child and Adolescent Mental Health (CAMHS) and Paediatric Neurodisability services in Sheffield. HT is an on-line multi-media (animated) suite of questionnaires and neuropsychological test games developed over four years at Great Ormond St and Guy’s St.Thomas NHS Trusts. The system has been designed to enable children (as young as five) and adolescents with a range of neurodevelopmental and neuropsychiatric disorders, parents, and teachers to input data through innovative computer-based electronic questionnaires. Following consent, we estimate to have 1300+ patients (increasing by approx 250 each year) plus their carers and teachers on the database. The database will provide a rich dataset of all children and young people in Sheffield with ADHD, which will include demographics, symptoms, pharmacological and non-pharmacological interventions, outcomes collected over the duration of service contact, which in most cases will be many years. The Health Tracker dataset will therefore provide a complete picture of a citywide cohort and a platform for further research as many of the participants will have consented to be approached for future related research. We envisage that Health Tracker will also provide clinicians with clinically useful information for practice. As part of our evidence appraisal we are writing a systematic review; ‘The long-term outcomes of attention-deficit hyperactivity disorder interventions: A systematic review of randomised controlled trials.’ Contact: [email protected]

Born in Bradford within our Healthy Children, Healthy Families Theme The Born in Bradford birth cohort Born in Bradford is a cohort of 13,500 children, born at Bradford Royal Infirmary between 2007 and 2010, their mothers and fathers (30,000 participants in total) whose health is being tracked from pregnancy through childhood and into adult life. The aim of Born in Bradford is to find out more about the causes of health and illness by studying people from all cultures and backgrounds as their lives unfold. Now that the BiB children are 6 -10 years old, families are being invited to take part in a large-scale face-to-face follow up where data on social and emotional wellbeing, cognition, physical and mental health will all be collected. The BiB cohort also uses data linkage with track the cohort; data sources include GP records, hospital admissions and education data. Contact: [email protected] Website: www.borninbradford.nhs.uk

Born in Bradford’s Better Start birth cohort The Better Start Bradford (BSB) programme is a Big Lottery funded initiative which aims to provide interventions to pregnant women and children aged 0-3 to improve socio-emotional development, language and communication and nutrition and obesity in three wards of Bradford. To evaluate the programme an experimental birth cohort called Born in Bradford’s Better Start (BiBBS) has been set up. The aim is to recruit 5,000 babies, their mothers and their mother’s partners over 5 years. In January 2016 recruitment to the cohort began and over 1000 women have joined the study to date. Questionnaires and measurements are conducted during pregnancy, and linked with information on attendance from the BSB interventions and routinely collected data (e.g. collected by health visitors, schools). BiBBS data will be used to understand the effects of project participation on children’s health and development. Contact: [email protected] Website: https://borninbradford.nhs.uk/research/ grants/better-start-bradford-innovation-hub

Delivering innovative research through effective partnerships

2

CARE 75+ within our Primary care based management of frailty in older people theme The Community Ageing Research 75+ (CARE 75+) is a study within our Primary care based management of frailty in older people theme. CARE 75+ is a national prospective cohort of community dwelling older people (≥75 years). It uses electronic data capture to collect data at five time points: baseline, 6, 12, 24 and 48 months. Data covers a wide range of variables including: physical and mental health, quality of life (QoL), living circumstances, lifestyle, education and occupation, social networks and statutory support, co-morbidities, medications, sleep, falls and pain. These data will enable researchers to investigate frailty transitions and potential modifiable risks. Participants are recruited via general practices and assessments take place in the participants’ homes. In addition, we are collecting blood samples for the future establishment of a bio-bank. This will allow researchers to investigate biological mechanisms which potentially contribute to frailty. Since 2015 the CARE 75+ cohort has recruited 450 participants across the North East, Yorkshire and Humber and the Midlands. Approximately 14% of the cohort is from a Black and Minority Ethnic (BME) background - predominantly from the South Asian community. Specific strategies for including people from BME groups have been built into the study design, including funding two researchers who speak additional languages (Punjabi, Mirpuri and Kashmiri) in the Leeds and Bradford sites. Our aim is to recruit up to a 1000 older people to CARE 75+. The CARE 75+ uses a Trials within Cohort (TwiCs) design. The vast majority of participants have agreed to be contacted about future studies and this has facilitated the recruitment of older people with a well-defined frailty status to two other studies. At present the cohort has sufficient numbers to support qualitative studies and small scale feasibility studies. In due course we expect to be able to embed pilot randomised controlled trials (RCTs) within the cohort. The CARE 75+ cohort has the potential to provide an efficient, cost effective means of undertaking research with older people as we continue to expand nationally to new sites in 2017. Contacts: [email protected] [email protected]

3

Collaboration for Leadership in Applied Health Research and Care Yorkshire and Humber

Citizen Science Cohort within our

Emergency and Urgent care dataset

Telehealth and Care Technologies theme

within our Avoiding Admissions and Attendance theme

It is important to involve members of the public when developing research and when looking to recruit research participants. This is because members of the public have valuable perspectives on varying conditions, and on the way people access and understand information. We can learn from these perspectives when designing and conducting research. However, the difficulty remains in the timely identification of people for a range of research areas and conditions. To help address this difficulty, the Citizen Science Database has been established, which aims to increase the ease by which members of the public can be recruited for research participation and for Patient and Public Involvement (PPI) activities. The Tact (telehealth and care technologies) Theme of the NIHR CLAHRC YH has worked with a number of individuals and organisations to develop and raise awareness of the database with the aim to continue its growth. The database will be a shared resource within the TaCT theme and other related groups. The organisations and individuals who have helped to develop the database include Sheffield 50+, The University of the Third Age (U3A), SITraN (Sheffield Institute for Translational Neuroscience) at the University of Sheffield, Parkinson’s UK and The Sheffield Teaching Hospitals NHS Foundation Trust (STH NHS FT). The database was established in June 2016 and has over 84 people signed up. The people currently on the database cover a wide number of conditions and interests. The database has already been successfully used to recruit to two research studies and one PPIworkshop. Contact: [email protected]

The development of this emergency and urgent care linked dataset is to address the lack of reliable data on the use of emergency care services in Yorkshire and Humber. Good quality data is required to accurately estimate the numbers and types of patients who might be managed in more appropriate settings and reduce pressure on emergency care services. This work has resulted in the first regional emergency and urgent care dataset linking routine data to evaluate the whole emergency and urgent care system from time of call to discharge to hospital. A year of complete ambulance service 999 and NHS 111 data from the Yorkshire Ambulance Service has been linked with every NHS acute hospital trust in the region. This dataset contains patient data on over 1.5 million emergency episodes of care. This has allowed a detailed picture to be generated on how patients access and use the emergency care system and which patient groups may be amenable to alternative, more appropriate care in the community. The analysis so far has identified the following key patient groups and established the different services they use: · Younger patients who are non-urgent attenders using the emergency department (ED) for healthcare that could be provided in primary care setting · Frail older people who place the greatest demand on ambulances and hospital resources but who could be managed without an emergency admission to hospital · Patients with acute mental health crisis who are conveyed unnecessarily to the ED. Further analysis of the dataset is underway to test the feasibility of interventions focused on providing more appropriate places of care for these key patient groups outside of hospital. Contact: [email protected]

Delivering innovative research through effective partnerships

4

Lifestyle Health and Wellbeing Cohort within our Mental Health and Comorbidity Theme

The aim of the survey is to provide information about the health and wellbeing of people with severe mental ill health. Data is being collected on socio-demographic characteristics, health status, diet, exercise, alcohol and smoking. Resulting information from the survey will be used in two ways. Firstly to compare lifestyle factors of people with severe mental ill health with those in the general population and secondly to inform future studies aiming to improve the physical health of people with severe mental ill health. The survey was piloted from March to September 2016 during which time 500 participants were recruited from both primary and secondary care. After piloting the study was opened to additional sites in both primary and secondary care and has currently recruited about 1900 participants from 13 secondary care trusts and five CCGs across England. The current recruitment phase is ongoing and we plan to extend the study to further sites in both primary and secondary care. The cohort has the potential to be used to recruit to other studies for people with severe mental ill health and has recently been used to recruit to the SCIMITAR+ study, a study of a smoking cessation intervention for people with severe mental ill health and the DAWN-SMI study a study for people with severe mental ill health and diabetes.

Health and Wellbeing Survey Welcome to the Lifestyle Health and Wellbeing Survey Please help us by filling in this questionnaire. Your answers will help us understand how we can improve the health of people with severe mental ill health. The questionnaire will take about 10 minutes to complete. When you have completed the questionnaire, please return to the researchers at the University of York in the pre-paid envelope provided. You do not need a stamp.

Contact: [email protected] Website: www.york.ac.uk/healthsciences/research/ mental-health/projects/lifestylehealthandwellbeingsurvey

5

Collaboration for Leadership in Applied Health Research and Care Yorkshire and Humber

Yorkshire Health Study within our Public Health and Inequalities theme The Yorkshire Health Study (YHS) in the PHI theme builds on the South Yorkshire cohort a cmRCT study funded and supported by NIHR CLAHRC for South Yorkshire (an example of the infographics from that study is pictured below). Data collection includes socio-demographic characteristics (age, gender, ethnicity, education, employment, deprivation by postcode and NS-SEC), health status (recent health care use, medications, long term conditions, health related quality of life, life satisfaction), and lifestyle (Body Mass Index (BMI), diet and exercise activities, alcohol and smoking. The first recruitment phase (2010-2012) saw 27,806 patients recruited (15.9% response rate) from 43 GP surgeries in the South Yorkshire and surrounding Derbyshire region. The second recruitment phase which widened the study area to the Yorkshire and Humber region is ongoing. The study currently has over 47,000 participants respondents (age 16-85 years). We are now in the process of creating the linked database with HES and ONS data. As well as survey and longitudinal data, the cohort provides a unique platform for fast recruitment to health studies in the region – including pragmatic randomised controlled trials using the ‘Trials within Cohorts’ (TwiCs) methodology (Relton et al, 2010). 22 studies have successfully recruited using the platform. Contact: [email protected] Website: www.yorkshirehealthstudy.org

South Yorkshire Cohort participants May 2013

Delivering innovative research through effective partnerships

6

Delivering innovative research through effective partnerships National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care, Yorkshire and Humber (NIHR CLAHRC YH) Director Professor Susan Mawson [email protected] 0114 226 5518 NIHR CLAHRC YH, Sheffield Teaching Hospitals, NHS FT D Floor, Royal Hallamshire Hospital Glossop Road, Sheffield, S10 2JF www.clahrc-yh.nihr.ac.uk Twitter @clahrcyh The research was funded by the NIHR CLAHRC Yorkshire and Humber. www.clahrc-yh.nihr.ac.uk. The views expressed are those of the author(s), and not necessarily those of the NHS, the NIHR or the Department of Health. Produced June 2017 © Sheffield Teaching Hospitals NHS FT