Health and Care Research Unit
Established in 1966, the Health and Care Research Unit (HCRU) is one of the UK's leading health services research groups.
Research
The Health Care Research Unit (formerly the Medical Care Research Unit) has been conducting high-quality health services research for over 50 years.
Our aim is to carry out research that influences health care, social care and third sector practice and policy for the benefit of service users and the public. We develop and evaluate services and technologies to measure the impact on user outcomes, service effectiveness and the wider social and economic effects.
Our aim is to help improve people’s health through high-quality research.
HCRU staff support ScHARR Postgraduate Taught Programmes and Postgraduate Research Students undertaking PhD studies.
HCRU Director
Research themes
Using qualitative research with RCTs/process evaluations (theme lead Professor Alicia O'Cathain)
- HighCALs research programme
-
A programme to develop and evaluate a complex intervention to improve nutritional management for people with Amyotrophic Lateral Sclerosis (ALS). Find out more about the project here.
- STOP-OHSS (Shaping and Trialling Outpatient Protocols for Ovarian HyperStimulation Syndrome)
-
A feasibility study and randomised controlled trial, with internal pilot, to assess the clinical and cost-effectiveness of earlier active management of OHSS. We lead the qualitative research. Find out more about the project here.
- ACTiF
-
Development and evaluation of an intervention to support Adherence to treatment in adults with Cystic Fibrosis (ACtiF). Find out more about the project here.
Objectives
- To embed adherence measurement in routine Cystic Fibrosis care by (i) building the IT infrastructure to capture adherence data from nebulisers and dry powders (ii) developing a web-portal ‘CF Healthhub’ to display adherence data to people with Cystic Fibrosis (PWCF) and clinicians, and (iii) co-producing the web-portal interface with patients and clinicians to facilitate maximum utility.
- To develop a Behaviour Change Intervention (BCI) that uses feedback of measured adherence data, linked to a range of evidence based interventions including Problem Solving and Implementation Plans to increase adherence.
- To test the cost effectiveness of the BCI by (i) exploring its feasibility and acceptability in a mixed methods study, (ii) testing its efficacy in an RCT of 550 patients in 12 CF Units, (iii) understanding its implementation in practice using a process evaluation, and (iv) modelling its cost effectiveness.
Team
- Dr Martin Wildman
- Professor Alicia O'Cathain
- Mr John Ainsworth
- Professor Madelynne Arden
- Mr Daniel Beever
- Professor Judy Bradley
- Professor Iain Buchan
- Professor Stuart Elborn
- Professor Rachel Elliot
- Dr Daniel Hind
- Ms Marlene Hutchings
- Professor Susan Michie
- Professor Mohammed A Mohammed
- Professor Jon Nicholl
- Dr Paul Tappenden
- Professor Stephen Walters
- Mr Robert Rathbone
- Susan Kirkpatrick
Funding
NIHR Applied Research Programme Grant £2M.
Timing
Start date March 2015, for 5 years.
Contact
For more information, please contact Dr Martin Wildman on martin.wildman@sth.nhs.uk.
- QUART
-
Maximising the value of combining qualitative research and randomised controlled trials in health research (The QUART study). Find out more about the project here.
Team
- A O’Cathain School of Health and Related Research (ScHARR), University of Sheffield
- KJ Thomas ScHARR, University of Sheffield
- SJ Drabble ScHARR, University of Sheffield
- A Rudolph ScHARR, University of Sheffield
- J Hewison Leeds Institute of Health Sciences, University of Leeds
Funding
MRC Methodology Research Panel
Summary
Background: Researchers often undertake qualitative research with randomised controlled trials of health interventions, particularly when evaluating the effectiveness of complex interventions.
Aims: To systematically explore how qualitative research is being used with trials and identify ways of maximising its value to the trial endeavour of providing evidence of effectiveness of health interventions.
Design: A sequential mixed methods study with four components.
Methods: 1. Database search of peer-reviewed journals between January 2008 and September 2010 for articles reporting the qualitative research undertaken with specific trials. 2. Systematic search of database of registered trials to identify studies combining qualitative research and trials. 3. Survey of 200 lead investigators of trials with no apparent qualitative research. 4. Semi-structured telephone interviews with 18 researchers purposively sampled from the first three methods.
Results: Qualitative research was undertaken with at least 12% of trials. A large number of articles reporting qualitative research undertaken with trials (n=296) were published between 2008 and 2010. 28% (82/296) of articles reported qualitative research undertaken at the pre-trial stage. The articles focused on 22 aspects of the trial within 5 broad categories. Some articles focused on more than one aspect of the trial, totalling 356 examples. The qualitative research focused on the intervention being trialled (71%, 254/356); the design, process and conduct of the trial (15%, 54/356); the outcomes of the trial (1%, 5/356); the measures used in the trial (3%, 10/356); and the target condition for the trial (9%, 33/356). The potential value of the qualitative research to the trial endeavour included improving the external validity of trials and facilitating interpretation of trial findings. This value could be maximised by using qualitative research more at the pre-trial stage and reporting findings with explicit attention to the implications for the trial endeavour. During interviews, three models of study were identified: qualitative research as peripheral to the trial, qualitative research as ‘add-on’ to the trial, and a study with qualitative research and trial as essential components, with the latter model offering more opportunity to maximise the value of the qualitative research. Interviewees valued the use of qualitative research with trials and identified team structures and wider structural issues within health research as barriers to maximising the value of qualitative research.
Conclusion: A large number of articles were published between 2008 and 2010, addressing a wide range of aspects of trials. There were examples of this research affecting the trial by modifying interpretation of trial findings, developing and refining interventions for testing in the trial, and changing the measures used in the trial. However, researchers are not necessarily maximising the value of qualitative research undertaken with trials to the evidence of effectiveness of health interventions. They can maximise value by: promoting its use at the pre-trial stage to ensure that the intervention and trial conduct is optimised at the main trial stage; being explicit about the conclusions for the trial endeavour in peer-reviewed journal articles reporting the qualitative research; and valuing the contribution of the qualitative research as much as the trial. O’Cathain A, Thomas KJ, Drabble SJ, Rudolph A, Goode J, Hewison J. Maximising the value of combining qualitative research and randomised controlled trials in health research: the QUAlitative Research in Trials (QUART) study – a mixed methods study. Health Technol Assess 2014;18(38).
Publications
- O’Cathain A, Thomas KJ, Drabble SJ, Rudolph A, Goode J, Hewison J. Maximising the value of combining qualitative research and randomised controlled trials in health research: the QUAlitative Research in Trials (QUART) study – a mixed methods study. Health Technol Assess 2014;18(38).
- O’Cathain A, Goode J, Drabble SJ, Thomas KJ, Rudolph A, Hewison J. Getting added value from using qualitative research with randomised controlled trials: A qualitative interview study. Trials 2014;15:215.
- Drabble SJ, O’Cathain A, Thomas KJ, Rudolph A, Hewison J. Describing qualitative research undertaken with randomised controlled trials in grant proposals: a documentary analysis. BMC Medical Research Methodology 2014, 14:24.
- O’Cathain A, Thomas KJ, Drabble SJ, Rudolph A, Hewison J. What can qualitative research do for randomised controlled trials? A systematic mapping review. BMJ Open 2013;3:e002889.
Conference
The MRC Hubs for Trials Methodology Research funded a day conference in November 2012 to disseminate the work. They also funded a workshop to develop guidance on using qualitative research at the pilot/feasibility stage of a trial. During this workshop, links were made with a group developing guidance for process evaluations in public health trials and researchers interested in how clinical trials units undertake qualitative research. These associations have produced publications:
- Moore G, Audrey S, Barker M, Bond L, Bonell C, Cooper C, Hardeman W, Moore L, O’Cathain A, Tannaze T, Wight D, Baird J. Process evaluation in complex public health intervention studies: the need for guidance. J Epidemiol Community Health 2013;0:1–2. doi:10.1136/jech-2013-202869
- Cooper C, O’Cathain A, Hind D, Adamson J, Lawton J, Baird W. Conducting qualitative research within Clinical Trials Units: Avoiding potential pitfalls. Contemporary Clinical Trials 2014;38:338–343
Learning Disability (theme lead Dr Liz Croot)
- WILD
-
Modified a mainstream commercial weight loss programme for use with people with learning disabilities. Find out more about the project here.
- EQUALD
-
A co-production of two toolkits of resources to promote EQUal Access to flexible support planning for Adults with Learning Disabilities (EQUALD).
Twitter: @EquALDStudy
This study will improve our understanding of how Individual Support Funds (ISFs) are used and what people and organisations are doing to make ISFs successful.The study will use co-production to develop two toolkits: to support systems within social care to develop, deliver and maintain successful ISFs; and to support adults with learning disabilities to decide whether to take up an offer of ISFs. The project takes a realist perspective incorporating a complex systems approach.
This perspective is theory-driven and aims to answer the question of what works, for whom, in what circumstances and how?
Background
In 2020/21, 39% of the money spent on adult social care was for adults with learning disabilities costing £6.3 billion. Social care for adults with learning disabilities is mostly funded through personal budgets.
Personal budgets are allocated according to an assessment of an individual’s eligible support needs, to allow people choice and control over the support they receive. However, these aims are not realised for many adults with learning disabilities because they have neither the knowledge or skills to manage their budget for themselves as a direct payment.
Instead, most personal budgets for adults with learning disabilities are held and managed by local councils. This often means the individual does not know, or is not told, their own budget allocation or how their money is spent.
Individual service funds (ISFs) can help. They offer a way for people to choose their support without having to buy it themselves or manage a budget. With an ISF, the council pays a support provider to work with the person to choose how they receive support.
Successful ISFs allow adults with learning disabilities and their allies to work creatively with a provider to develop a tailored support plan, linked to their assessed outcomes, that uses their strengths and community assets, and which is agile enough to adapt quickly to changing needs.
Many people feel more independent and in control when their funding is individualised. The problem is that very few adults with learning disabilities are offered an ISF. Some local authorities do not have processes in place to pay support providers. Social workers worry about how to check the quality of support. Support providers may not have ways to record how much each person has spent on their support. Some adults with learning disabilities are not sure whether an ISF is right for them, or what to do if it does not go well.
ISFs offer the benefits of individualised funding without the recipient or their allies taking on the burden of managing a budget. However, significant gaps in knowledge persist regarding how best to implement ISFs and how to overcome the barriers to their use within adult social care.
Aims
- To understand how important mechanisms operate in the context of social care systems to support or hinder the offer, uptake, and sustained provision of successful ISFs for adults with learning disabilities.
- To co-produce and carry out a formative evaluation of actionable toolkits of resources to support the delivery of ISFs at scale for this population.
Design
The project involves five work packages which will be undertaken sequentially
We will recruit ten key representatives from commissioners, support planning, service providers, adults with learning disabilities and carers to an expert stakeholder group. This group will meet throughout the project and knowledge from the group will be integrated into the project methods, findings and outputs.
We will conduct a realist review of the published research, policy and grey literature to develop and test theories of change associated with ISFs. This will provide depth to our understanding of current ISFs models, their principles and characteristics and the mechanisms critical to successful delivery of ISFs.
We will undertake realist interviews with key informants and two local authorities which offer ISFs. We will interview adults with learning disabilities who have an ISF, family members, social care providers, commissioning mangers and other local authority staff to provide insight into the mechanisms of ISFs and the contexts which mediate these mechanisms. This work package will develop a set of refined explanations about how adult social care systems can be configured to deliver ISFs which appeal to adults with learning disabilities and contribute to improved outcomes in social care.
We will conduct co-production workshops to produce two parallel actionable toolkits: to support systems within social care to develop, deliver and maintain successful ISFs; and to support adults with learning disabilities to decide whether to take up an offer of ISFs. These workshops will be iterative, and the outputs will be cumulative, so we aim to retain the same group of stakeholders throughout the process as far as possible.
We will identify two local authorities who do not currently offer ISFs to take part in a developmental evaluation to explore the relevance, acceptability and utility of the prototype tools and inform further refinement.
The culmination of these work packages will be two derived actionable toolkits. The first to support the development, delivery and monitoring of ISFs by those working in adult social care. The second to support the uptake and management of an ISF by adults with learning disabilities and their allies.
Workforce (theme lead Dr Emily Wood)
- RoHMS (Retention of Mental Health Staff)
-
Research project to investigate variation in, and determinants of, mental health care staff retention. Find out more about the project here.
Third Sector Organisations and Social Prescribing (theme lead Dr Alexis Foster)
- Implementing patient reported outcome measures
- Green Social Prescribing
Palliative Care (theme lead Dr Paul Taylor)
- ENCOMPASS
- ECHO
- The Yorkshire Palliative Care Research Network
Developing complex interventions (theme lead Professor Alicia O'Cathain)
- CARDIAC PREHAB-UK Prehabilitation before cardiac surgery in the UK
-
Dr Maria Pufulete From University Hospitals Bristol is leading this NIHR Programme Development Grant to design a prehabilitation programme to support patients undergoing heart surgery and test whether it can be implemented in the pre-operative clinical pathway and whether it works. In order to achieve these aims, we need to spend some time exploring and reviewing the best way to get this done.
- Creative co-design, knowledge mobilisation and musculoskeletal physiotherapy
- INDEX (IdentifyiNg and assessing different approaches to DEveloping compleX interventions - MRC funded guidance)
-
Summary
The aim of this study was to produce guidance for researchers on how to develop complex interventions to improve health or health care outcomes. The objectives were to: 1. Identify and describe the different approaches taken to intervention development, the rationales for their use, and any implications for the future utility of the interventions. 2. Compare and contrast different intervention development approaches, the methods of data collection and analysis they used, considering strengths and limitations overall and for different contexts. 3. Understand the history and challenges of intervention development from the perspectives of experienced researchers and wider stakeholders e.g. research funders, public and patient representatives. 4. Measure stakeholder consensus on the key aspects of intervention development and explore the reasons for any lack of consensus. 5. Offer guidance to researchers on good practice, with examples from different approaches.
The design was a sequential mixed methods study in 3 phases. In phase 1 we undertook three systematic reviews of literature on intervention development. The first identified different approaches and methods in primary intervention research and expert description and critiques. The second was an in-depth analysis of the application of primary intervention development research to improve health or health care outcomes. The third was a review of a sample of successful interventions and the intervention development approaches they used. In phase 2 we identified the challenges of intervention development in a qualitative interview study, and considered with stakeholders how to bring together the learning from our data collection. In phase 3 we undertook a consensus exercise to identify core aspects of intervention development.
Sponsor
Team
- PI: Prof. Alicia O’Cathain – University of Sheffield
- Dr Elizabeth Croot – University of Sheffield
- Dr Edward Duncan – University of Stirling
- Prof. Pat Hoddinott – University of Stirling
- Prof. Lucy Yardley – University of Southampton
- Dr Katrina Turner - University of Bristol
- University of Stirling Researcher: Dr Nikki Rousseau
- University of Sheffield Researcher: Dr Katie Sworn
- Administrative Assistant: Veronica Fibisan – Sheffield
For further details about this study, please contact Veronica Fibisan, administrator assistant at v.fibisan@sheffield.ac.uk.
Downloads
- The guidance paper (PDF, 557KB)
- Extended guidance (PDF, 758KB)
- Overview of published approaches to intervention development (PDF, 1.3MB)
- Systematic review of primary studies (PDF, 915KB)
- Qualitative findings: the meaning of 'success' (PDF, 543KB)
- Qualitative findings about design (PDF, 430KB)
- ADAPT (guidance for adapting effective interventions to new contexts)
-
Modified a main stream commercial weight loss programme for use with people with learning disabilities. Find out more about the project here.
- WILD
- ACTiF
-
Development and evaluation of an intervention to support Adherence to treatment in adults with Cystic Fibrosis (ACtiF).
Objectives
- To embed adherence measurement in routine Cystic Fibrosis care by (i) building the IT infrastructure to capture adherence data from nebulisers and dry powders (ii) developing a web-portal ‘CF Healthhub’ to display adherence data to people with Cystic Fibrosis (PWCF) and clinicians, and (iii) co-producing the web-portal interface with patients and clinicians to facilitate maximum utility.
- To develop a Behaviour Change Intervention (BCI) that uses feedback of measured adherence data, linked to a range of evidence based interventions including Problem Solving and Implementation Plans to increase adherence.
- To test the cost effectiveness of the BCI by (i) exploring its feasibility and acceptability in a mixed methods study, (ii) testing its efficacy in an RCT of 550 patients in 12 CF Units, (iii) understanding its implementation in practice using a process evaluation, and (iv) modelling its cost effectiveness.
Team
- Dr Martin Wildman
- Professor Alicia O'Cathain
- Mr John Ainsworth
- Professor Madelynne Arden
- Mr Daniel Beever
- Professor Judy Bradley
- Professor Iain Buchan
- Professor Stuart Elborn
- Professor Rachel Elliot
- Dr Daniel Hind
- Ms Marlene Hutchings
- Professor Susan Michie
- Professor Mohammed A Mohammed
- Professor Jon Nicholl
- Dr Paul Tappenden
- Professor Stephen Walters
- Mr Robert Rathbone
- Susan Kirkpatrick
Funding
NIHR Applied Research Programme Grant £2M.
Timing
Start date March 2015, for 5 years.
Contact
For more information, please contact Dr Martin Wildman on martin.wildman@sth.nhs.uk.
- Patient-Centred Abdominal Aortic Aneurysm Study (PCAAAS)
-
A study to improve the quality of care for men who have regular screening to check on the growth of an abdominal aortic aneurysm (AAA).
Dentistry safety (theme lead Professor Jon Nicholl)
- IDEA
-
The Invasive Dentistry – Endocarditis Association Study
- PJI
-
Do Invasive Dental Procedures Cause Prosthetic Joint Infections?
- ISPIE
-
Infective endocarditis (IE) is a serious and often fatal infection of the heart’s inner lining, particularly the heart valves. Its incidence has increased over the past decade. Once detected IE is treated by antibiotics, but controversy remains over whether to use antibiotics to help prevent IE – called antibiotic prophylaxis (AP). In the past, all international guideline committees recommended AP for patients undergoing certain invasive medical and dental procedures and who were considered moderate or high risk of developing IE. However, there was limited evidence linking these procedures to IE or for the effectiveness of AP in IE prevention. This, coupled with concerns about the risk of adverse reactions to the antibiotics used, led the American Heart Association (AHA) and European Society for Cardiology (ESC) to recommend restricting AP use to high IE-risk individuals undergoing invasive dental procedures. In the UK, the National Institute for Health and Care Excellence (NICE) recommended the complete cessation of AP use to prevent IE.
We undertook the I-SPIE study, funded by a British Heart Foundation Project Grant, to establish whether IE is linked to invasive procedures, in order to provide evidence to inform international guidelines. We used National Health Service data to identify all reported cases of IE in England between 2010 and 2016. During this period AP was not recommended in England, meaning any link between procedure and IE was unlikely to be hidden by AP use. We identified 14,713 admissions to hospital for IE and looked for the incidence of different invasive procedures in the 3 months immediately prior to IE-hospital admission and compared this the incidence of these procedures in the preceding 12 months. This type of study is called a “case crossover” study, and procedures that are more common in the 3 months before IE could indicate a causal relationship with IE.
The findings of the study were published in Heart in 2023. We estimate that the chance of developing IE roughly doubles (or in other words, a relative increase of 100%) in the three months following dental extraction, and increased by between 50 to 100% for other procedures including a permanent pacemaker or defibrillator, upper and lower gastrointestinal endoscopy and bone marrow biopsy. Bronchoscopy and blood transfusions or plasma exchange were associated with 33% and 20% relative increases in IE respectively.
Nevertheless, IE is uncommon and even a 100% increase leads to very few additional cases of IE. For individuals with a high pre-existing risk of IE, antibiotics prior of these procedures might have a role in reducing the subsequent risk of IE. For all others (which amount to more than 99% of the population), the benefits of routine AP prescription are outweighed by other risks, including antibiotic resistance. This is illustrated by the below figure which shows the estimated number of excess IE cases attributable to each procedure for each risk group. The actual number of preventable cases is lower still, since AP is not 100% effective.
In response to these findings, both The European Society for Cardiology (ESC) and the American Heart Association (AHA) have referenced I-SPIE and the need to consider the use of AP prevention in high risk individuals undergoing these invasive procedures. The AHA Scientific Advisory “Nondental Invasive Procedures and Risk of Infective Endocarditis: Time for a Revisit: A Science Advisory From the American Heart Association” advises clinicians to consider AP cover of invasive medical procedures for patients considered at high IE-risk. It also recommends new research in this area and directs the AHA guideline committee to specifically consider if AP should be recommended for certain invasive medical procedures when the AHA guidelines are next reviewed. The ESC undertook a major review of their IE prevention guidelines and revised their recommendation against the use of AP to prevent IE following non-dental invasive procedures. Instead, they now recommend: “Systemic antibiotic prophylaxis may be considered for high-risk patients undergoing an invasive diagnostic or therapeutic procedure of the respiratory, gastrointestinal, genitourinary tract, skin, or musculoskeletal systems.”
Methodological research (theme lead Professor Alicia O'Cathain)
- RHABIT (Recording Harms in Behavioural change Intervention Trials)
-
- Learning from COVID-19 efficient trial adaptations
- Find out more about the project here.
- INDEX (IdentifyiNg and assessing different approaches to DEveloping compleX interventions - MRC funded guidance)
-
Summary
The aim of this study was to produce guidance for researchers on how to develop complex interventions to improve health or health care outcomes. The objectives were to: 1. Identify and describe the different approaches taken to intervention development, the rationales for their use, and any implications for the future utility of the interventions. 2. Compare and contrast different intervention development approaches, the methods of data collection and analysis they used, considering strengths and limitations overall and for different contexts. 3. Understand the history and challenges of intervention development from the perspectives of experienced researchers and wider stakeholders e.g. research funders, public and patient representatives. 4. Measure stakeholder consensus on the key aspects of intervention development and explore the reasons for any lack of consensus. 5. Offer guidance to researchers on good practice, with examples from different approaches.
The design was a sequential mixed methods study in 3 phases. In phase 1 we undertook three systematic reviews of literature on intervention development. The first identified different approaches and methods in primary intervention research and expert description and critiques. The second was an in-depth analysis of the application of primary intervention development research to improve health or health care outcomes. The third was a review of a sample of successful interventions and the intervention development approaches they used. In phase 2 we identified the challenges of intervention development in a qualitative interview study, and considered with stakeholders how to bring together the learning from our data collection. In phase 3 we undertook a consensus exercise to identify core aspects of intervention development.
Sponsor
Team
- PI: Prof. Alicia O’Cathain – University of Sheffield
- Dr Elizabeth Croot – University of Sheffield
- Dr Edward Duncan – University of Stirling
- Prof. Pat Hoddinott – University of Stirling
- Prof. Lucy Yardley – University of Southampton
- Dr Katrina Turner - University of Bristol
- University of Stirling Researcher: Dr Nikki Rousseau
- University of Sheffield Researcher: Dr Katie Sworn
- Administrative Assistant: Veronica Fibisan – Sheffield
For further details about this study, please contact Veronica Fibisan, administrator assistant at v.fibisan@sheffield.ac.uk.
Downloads
- The guidance paper (PDF, 557KB)
- Extended guidance (PDF, 758KB)
- Overview of published approaches to intervention development (PDF, 1.3MB)
- Systematic review of primary studies (PDF, 915KB)
- Qualitative findings: the meaning of 'success' (PDF, 543KB)
- Qualitative findings about design (PDF, 430KB)
- QUART
-
Maximising the value of combining qualitative research and randomised controlled trials in health research (The QUART study). Find out more about the project here.
Team
- A O’Cathain School of Health and Related Research (ScHARR), University of Sheffield
- KJ Thomas ScHARR, University of Sheffield
- SJ Drabble ScHARR, University of Sheffield
- A Rudolph ScHARR, University of Sheffield
- J Hewison Leeds Institute of Health Sciences, University of Leeds
Funding
MRC Methodology Research Panel
Summary
Background: Researchers often undertake qualitative research with randomised controlled trials of health interventions, particularly when evaluating the effectiveness of complex interventions.
Aims: To systematically explore how qualitative research is being used with trials and identify ways of maximising its value to the trial endeavour of providing evidence of effectiveness of health interventions.
Design: A sequential mixed methods study with four components.
Methods: 1. Database search of peer-reviewed journals between January 2008 and September 2010 for articles reporting the qualitative research undertaken with specific trials. 2. Systematic search of database of registered trials to identify studies combining qualitative research and trials. 3. Survey of 200 lead investigators of trials with no apparent qualitative research. 4. Semi-structured telephone interviews with 18 researchers purposively sampled from the first three methods.
Results: Qualitative research was undertaken with at least 12% of trials. A large number of articles reporting qualitative research undertaken with trials (n=296) were published between 2008 and 2010. 28% (82/296) of articles reported qualitative research undertaken at the pre-trial stage. The articles focused on 22 aspects of the trial within 5 broad categories. Some articles focused on more than one aspect of the trial, totalling 356 examples. The qualitative research focused on the intervention being trialled (71%, 254/356); the design, process and conduct of the trial (15%, 54/356); the outcomes of the trial (1%, 5/356); the measures used in the trial (3%, 10/356); and the target condition for the trial (9%, 33/356). The potential value of the qualitative research to the trial endeavour included improving the external validity of trials and facilitating interpretation of trial findings. This value could be maximised by using qualitative research more at the pre-trial stage and reporting findings with explicit attention to the implications for the trial endeavour. During interviews, three models of study were identified: qualitative research as peripheral to the trial, qualitative research as ‘add-on’ to the trial, and a study with qualitative research and trial as essential components, with the latter model offering more opportunity to maximise the value of the qualitative research. Interviewees valued the use of qualitative research with trials and identified team structures and wider structural issues within health research as barriers to maximising the value of qualitative research.
Conclusion: A large number of articles were published between 2008 and 2010, addressing a wide range of aspects of trials. There were examples of this research affecting the trial by modifying interpretation of trial findings, developing and refining interventions for testing in the trial, and changing the measures used in the trial. However, researchers are not necessarily maximising the value of qualitative research undertaken with trials to the evidence of effectiveness of health interventions. They can maximise value by: promoting its use at the pre-trial stage to ensure that the intervention and trial conduct is optimised at the main trial stage; being explicit about the conclusions for the trial endeavour in peer-reviewed journal articles reporting the qualitative research; and valuing the contribution of the qualitative research as much as the trial. O’Cathain A, Thomas KJ, Drabble SJ, Rudolph A, Goode J, Hewison J. Maximising the value of combining qualitative research and randomised controlled trials in health research: the QUAlitative Research in Trials (QUART) study – a mixed methods study. Health Technol Assess 2014;18(38).
Publications
- O’Cathain A, Thomas KJ, Drabble SJ, Rudolph A, Goode J, Hewison J. Maximising the value of combining qualitative research and randomised controlled trials in health research: the QUAlitative Research in Trials (QUART) study – a mixed methods study. Health Technol Assess 2014;18(38).
- O’Cathain A, Goode J, Drabble SJ, Thomas KJ, Rudolph A, Hewison J. Getting added value from using qualitative research with randomised controlled trials: A qualitative interview study. Trials 2014;15:215.
- Drabble SJ, O’Cathain A, Thomas KJ, Rudolph A, Hewison J. Describing qualitative research undertaken with randomised controlled trials in grant proposals: a documentary analysis. BMC Medical Research Methodology 2014, 14:24.
- O’Cathain A, Thomas KJ, Drabble SJ, Rudolph A, Hewison J. What can qualitative research do for randomised controlled trials? A systematic mapping review. BMJ Open 2013;3:e002889.
Conference
The MRC Hubs for Trials Methodology Research funded a day conference in November 2012 to disseminate the work. They also funded a workshop to develop guidance on using qualitative research at the pilot/feasibility stage of a trial. During this workshop, links were made with a group developing guidance for process evaluations in public health trials and researchers interested in how clinical trials units undertake qualitative research. These associations have produced publications:
- Moore G, Audrey S, Barker M, Bond L, Bonell C, Cooper C, Hardeman W, Moore L, O’Cathain A, Tannaze T, Wight D, Baird J. Process evaluation in complex public health intervention studies: the need for guidance. J Epidemiol Community Health 2013;0:1–2. doi:10.1136/jech-2013-202869
- Cooper C, O’Cathain A, Hind D, Adamson J, Lawton J, Baird W. Conducting qualitative research within Clinical Trials Units: Avoiding potential pitfalls. Contemporary Clinical Trials 2014;38:338–343
- Mixed Methods research
-
Alicia O’Cathain is a Professor of Health Services Research at the School of Health and Related Research. She has undertaken numerous mixed methods studies on topics including nurse telephone triage (survey and interviews), evidenced based leaflets in maternity care (randomised controlled trial and ethnographic study), the introduction of a primary angioplasty service (interviews, survey, and case studies), computerised cognitive behaviour therapy for people with multiple sclerosis and depression (pilot trial and interviews), the use of qualitative research with trials (surveys and interviews), and avoidable emergency admissions (analysis of routine data and case studies). She was Associate Editor of the Journal of Mixed Methods Research 2007-2012. She has written a number of papers and book chapters on how to do mixed methods research:
- Cooper C, O’Cathain A, Hind D, Adamson J, Lawton J, Baird W. Conducting qualitative research within Clinical Trials Units: Avoiding potential pitfalls. Contemporary Clinical Trials 2014;38:338–343.
- O’Cathain A, Thomas KJ, Drabble SJ, Rudolph A, Goode J, Hewison J. Maximising the value of combining qualitative research and randomised controlled trials in health research: the QUAlitative Research in Trials (QUART) study – a mixed methods study. Health Technol Assess 2014;18(38).
- O’Cathain A, Goode J, Drabble SJ, Thomas KJ, Rudolph A, Hewison J. Getting added value from using qualitative research with randomised controlled trials: A qualitative interview study. Trials 2014;15:215.
- Drabble SJ, O’Cathain A, Thomas KJ, Rudolph A, Hewison J. Describing qualitative research undertaken with randomised controlled trials in grant proposals: a documentary analysis. BMC Medical Research Methodology 2014, 14:24.
- Moore G, Audrey S, Barker M, Bond L, Bonell C, Cooper C, Hardeman W, Moore L, O’Cathain A, Tannaze T, Wight D, Baird J. Process evaluation in complex public health intervention studies: the need for guidance. J Epidemiol Community Health 2013;0:1–2. doi:10.1136/jech-2013-202869
- O’Cathain A, Thomas KJ, Drabble SJ, Rudolph A, Hewison J. What can qualitative research do for randomised controlled trials? A systematic mapping review. BMJ Open 2013;3:e002889.
- Curry LA, Krumholz HM, O’Cathain A, Plano Clark VL, Cherlin E, Bradley EH. Mixed methods in biomedical and health services research. Circulation: Cardiovascular Quality and Outcomes 2013;6:119-123.
- Curry LA, O'Cathain A, Plano Clark VL, Aroni R, Fetters M, Berg D. The role of group dynamics in mixed methods health sciences research teams. Journal of Mixed Methods Research 2012; 6(1):5-20.
- O’Cathain A, Murphy E, Nicholl JP. Three techniques for integrating qualitative and quantitative methods in health services research. BMJ 2010; 341:1147-1150.
- O’Cathain A. Mixed methods involving qualitative research. In Bourgeault I, Dingwall R, DeVries R (eds). The Sage Handbook of Qualitative Methods in Health Research. Sage Publications, 2010, pp 575-588.
- O’Cathain A. Assessing the quality of mixed methods research: toward a comprehensive framework. In Tashakkori & Teddlie (eds). Handbook of Mixed Methods Research, Second Edition, 2010, pp531-555.
- O’Cathain A. Reporting mixed methods projects. In Andrew S, Halcomb E (eds). Mixed Methods Research for Nursing and the Health Sciences. Blackwell Publishing, 2009, pp135-158.
- O’Cathain. Mixed methods research in the health sciences. A quiet revolution. Editorial. Journal of Mixed Methods Research 2009; 3(1): 3-6.
- O’Cathain A, Murphy E, Nicholl JP. Dysfunctional, multidisciplinary or interdisciplinary? Team working in mixed methods research. Qualitative Health Research 2008;18(11): 1574-1585
- O’Cathain A, Murphy E, Nicholl JP. The quality of mixed methods studies in health services research. Journal of Health Services Research and Policy, 2008;13:92-98. DOI:10.1258/jsrp.2007.007074
- O’Cathain A, Murphy E, Nicholl JP. Why, and how, mixed methods research is undertaken in health services research: a mixed methods study. BMC Health Services Research 2007; 7:85.
- O’Cathain A, Murphy E, Nicholl JP. Integration and publications as indicators of ‘yield’ from mixed methods studies. Journal of Mixed Methods Research 2007; 1(2): 147-163.
- O’Cathain A, Thomas KT. Combining qualitative and quantitative methods. In Pope C, Mays N (eds). Qualitative Research in Health Care. Blackwell Publishing Ltd: Oxford, 2006, Third Edition, pp102-111.
- O’Cathain A, Thomas KJ. “Any other comments?” Open questions on questionnaires – a bane or a bonus to research? BMC Medical Research Methodology 2004,4:25.
Health literacy (theme lead Professor Alicia O'Cathain)
- Health Literacy Interventions (HLI)
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Identifying health literacy interventions that reduce the use of primary care and emergency services for minor health issues. Find out more about the project here.
- Clear Conversations: Improving Verbal Health Literacy
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A project undertaken in partnership with Derbyshire Community Health Service NHS Foundation Trust and Derbyshire County Council.
We specialise in
- mixed methods research
- qualitative research (non-participant observation, interviews, focus groups)
- qualitative evidence synthesis
- participatory-based research
HCRU Staff
- Elizabeth Croot
- Alice Dunning
- Veronica Fibisan
- Becky Field
- Nick Firth
- Alexis Foster
- Cheryl Grindell
- Jaqui Long
- Elizabeth Lumley
- Jon Nicholl
- Alicia O'Cathain
- Jennifer Read
- Paul Taylor
- Claire Williams
- Emily Wood
Teaching, PhDs and Knowledge Exchange
- Jennifer Read is Director of the Masters in Clinical Research. This course is for people working, or aspiring to work, in the field of clinical or health-related research within healthcare, clinical research, academic or commercial settings. It is also excellent preparation for doctoral/PhD study. PGDip, PGCert, Masters or standalone CPD module level study is supported and as are intercalating medical students.
- We run short courses in intervention development
- As part of knowledge transfer, HCRU are involved in supporting charities and third sector organisations to evaluate the impact of their work. This has included undertaking mixed methods studies to evaluate the impact of a national social prescribing scheme for people experiencing loneliness delivered by the British Red Cross and programmes delivered by Cruse bereavement services such as emotional support for emergency service personnel. Methods have included statistical analysis of routinely collected data and outcome measures to capture changes in wellbeing, qualitative methods to explore peoples’ experiences and Social Return on Investment analysis to understand whether services provide value for money. All evaluations have been delivered in conjunction with the third sector organisations to ensure the research produces useful learning for them. If you would like further information on how we can support research and evaluations please contact alexis.foster@sheffield.ac.uk
HCRU staff supervise PhDs in the fields of 'healthcare evaluation' and 'developing and evaluating interventions for long term conditions'. We work with colleagues in ScHARR to offer the best supervisory team for candidates. Current PhD candidates:
Candidate | Duration | Funder/Topic | Supervisor |
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Nick Firth | PT, starting June 2019 | Funded by NIHR Doctoral Fellowship scheme. “The Bigger Picture” How can we make psychological therapy more helpful for people in more deprived areas? | Lead supervisor: Professor Alicia O'Cathain. Co-supervisors: Professor Michael Barkham, Dr Jaime Delgadillo |
Cheryl Grindell | FT, starting October 2019 | Funded by University Scholarship. Exploring the role of co-design as a knowledge mobilisation strategy for musculoskeletal physiotherapy. | Lead supervisor: Professor Alicia O'Cathain. Co-supervisor: Dr Liz Croot |
Sean White | FT, starting September 2021 | Funded by NIHR Clinical Doctoral Fellowship. Exploring multidisciplinary decision making for feeding strategies in MND. | Second supervisor: Professor Alicia O'Cathain |
Nat Jones | FT, starting September 2020 | Funded by NIHR Clinical Doctoral Fellowship. Developing breakfast groups for people with stroke to improve psychosocial outcomes. | Lead Supervisor: Professor Alicia O'Cathain Co-supervisors: Professor Emeritus Sue Mawson and Professor Avril Drummond |
Jane Manson | FT, starting September 2023 | Funded by: NIHR Clinical Doctoral Fellowship. Models of palliative rehabilitation | Lead supervisor: Professor Alicia O'Cathain. Co-supervisors: Dr Paul Taylor and Professor Emeritus Sue Mawson |
Matt Gittus | FT, starting August 2023 | Funded by: THIS Doctoral Fellowship. Exploring variation in adherence to clinical practice guidelines in rare diseases using Autosomal Dominant Polycystic Kidney Disease as a model to improve the quality and safety of healthcare. | Lead supervisor: Dr James Fotehringham. Co-supervisor: Professor Alicia O'Cathain |
Gillian Martin | PT, starting October 2022 | Funded by Jersey Health and Community Services. Healthy lifestyle behaviours for adults with learning disabilities | Lead supervisor Dr Liz Croot, Co-supervisor Dr Chris Carroll. |
James Bird | PT, starting October 2022 | Funded by an NIHR In-practice Fellowship. People with learning disabilities: Developing a way to measure their oral health-related quality of life. | Lead supervisor Professor Zoe Marshman, Co-supervisors Professor Sarah Baker and Dr Liz Croot |
Collaborations
- We collaborate with third sector organisations, clinicians, and industry.
Contact us
Email: v.fibisan@sheffield.ac.uk