Doing Clinical Research
| Module title | Doing Clinical Research |
|---|---|
| Module code | HPDM150Z |
| Academic year | 2022/3 |
| Credits | 15 |
| Module staff |
| Duration: Term | 1 | 2 | 3 |
|---|---|---|---|
| Duration: Weeks | 0 | 12 | 0 |
| Number students taking module (anticipated) | 46 |
|---|
Module description
This is a fully online module.
During this module you will discover how strong communication with participants ensures good understanding, consent and confidence and how this contributes to study feasibility in your healthcare setting. Drawing on learning in the Integrity and Leadership module, you will consider the practicalities of doing clinical research, through scoping current evidence, maximising the potential of routinely collected data and project planning. Through facilitated group discussions and using case studies, you will explore different types of research studies and their potential challenges, such as how to improve participant recruitment and retention and implement continuous improvement strategies.
Module aims - intentions of the module
The aims of this module are to enable you to understand the importance of:
- How well written research questions ensure clinical research is appropriately directed
- How you as a researcher can engender a culture of continuous improvement in research development and management.
You will be encouraged to develop your understanding of different approaches to clinical research, developing your critical and reflexive reasoning to compare and contrast the adoption of a specific methodology, taking into consideration the need for a culture of continuous improvement to inform research and shape the way it is managed.
Intended Learning Outcomes (ILOs)
ILO: Module-specific skills
On successfully completing the module you will be able to...
- 1. Understand how to critically evaluate and recognise the differences between relevant key methodologies used in the design and development of a research project. Identifying the strengths and weaknesses of different approaches.
- 2. Be able to identify and justify the use of appropriate methodologies used in specific clinical research projects with respect to the delivery of the proposed outcomes of the project.
ILO: Discipline-specific skills
On successfully completing the module you will be able to...
- 3. Critically discuss the challenges of translating a particular clinical research methodology into practice and evaluate possible solutions to those challenges.
- 4. Understand the use of data with respect to continuous improvement and its importance within the context of clinical research both generally and in your area of practice.
ILO: Personal and key skills
On successfully completing the module you will be able to...
- 5. Critically evaluate a case study, considering how a project was translated and optimised for a given healthcare context or setting.
- 6. Demonstrate a reflective / reflexive approach to the case study evaluation and present a clear understanding of clinical research delivery in practice.
Syllabus plan
Whilst the module’s precise content may vary from year to year, an example of an overall structure is as follows:
This module is focussed on understanding how to translate a research proposal into deliverable clinical research. You will focus on key skills which will develop your understanding of Clinical Research Delivery in terms of translating theory into practice by building on your learning in module 1 (Integrity and Leadership in Research for Health and Healthcare). Your learning in this follow-on module will include facilitated, synchronous online study sessions, alongside engagement in online forum discussions with your peers as a learning community, and independent learning.
To achieve the learning outcomes of this module, you will:
- Reflect on why clinical research is important and understand what it can achieve.
- Consider how the current knowledge base impacts research development in relation to ongoing studies.
- Understand the clinical research process, aligning research programmes and research delivery processes with the needs of the UK health and care system:
- Understand that research is question-led and that the quality and focus of research questions strongly influences what research achieves.
- Consider how general research aims are translated into valuable and answerable questions (Local Feasibility); and
- Understand the need for alignment between research questions and study design and delivery.
- Use case studies of a purposive selection of contrasting clinical research paradigms, methodologies and designs to develop insight into, for example: suitability for different research questions and contexts, strengths and weaknesses, implications for delivery, implications for knowledge generation and application of findings.
- Understand how innovation and improvement can be applied to study delivery: (including use of digital technologies).
- Understand methods / processes for improving the speed and efficiency of study set-up.
- Explore the use of digital platforms to deliver clinical research.
- Understand the increasing use of innovative research designs. Adapt research delivery methods to take advantage of virtual processes and technologies in the current environment
- Understand how to make research more diverse and more relevant to your local area and the whole UK.
- Consider diverse contributions to clinical research from non-clinicians
- Understand how to work across complex boundaries with respect to research delivery.
- Learn how to communicate, promote and implement research findings effectively and with integrity.
- Understand how to improve visibility and impact of research delivery in the NHS.
Learning activities and teaching methods (given in hours of study time)
| Scheduled Learning and Teaching Activities | Guided independent study | Placement / study abroad |
|---|---|---|
| 12 | 138 | N/A |
Details of learning activities and teaching methods
| Category | Hours of study time | Description |
|---|---|---|
| Scheduled Learning & Teaching activities | 12 | Synchronous online group learning days with other students, module lead and practitioner facilitators. Working together to develop understanding in line with ILOs, group discussions, case studies, tutorials and presentations (facilitator and student). |
| Guided Independent Study | 24 | Online learning e.g. NIHR learn etc |
| Guided Independent Study | 27 | ELE learning activities (lectures, quizzes, podcasts etc.) |
| Guided Independent Study | 27 | Reading/web-based research |
| Guided Independent Study | 60 | Assessment preparation |
Formative assessment
| Form of assessment | Size of the assessment (eg length / duration) | ILOs assessed | Feedback method |
|---|---|---|---|
| Participation in online learning fora: tutor group / learning communities. | Regular short contributions including introductions, practice discussion, sharing good practice, developing understanding. | 1,2,6 | Peer and facilitator interaction on the online forum. |
| A formative task during a study session with a focus on translating a project into practice in your setting. | Group presentation and / or discussion. | All | Oral / written peer and tutor feedback. |
Summative assessment (% of credit)
| Coursework | Written exams | Practical exams |
|---|---|---|
| 100 | 0 | 0 |
Details of summative assessment
| Form of assessment | % of credit | Size of the assessment (eg length / duration) | ILOs assessed | Feedback method |
|---|---|---|---|---|
| Evaluation of a feasibility study. | 100 | 2000-words | All | Written report |
Details of re-assessment (where required by referral or deferral)
| Original form of assessment | Form of re-assessment | ILOs re-assessed | Timescale for re-assessment |
|---|---|---|---|
| Evaluation of a feasibility study (100%) | Evaluation of a feasibility study (2000 words) | All | Typically, within 6 weeks of the result. |
Re-assessment notes
Please refer to the student handbook
Please refer to the TQA section on Referral/Deferral: http://as.exeter.ac.uk/academic-policy-standards/tqa-manual/aph/consequenceoffailure/
Indicative learning resources - Basic reading
- Aarons, G. A., M. G. Ehrhart, L. R. Farahnak and M. Sklar (2014). "Aligning leadership across systems and organizations to develop a strategic climate for evidence-based practice implementation." Annu Rev Public Health 35: 255-274.
- Barr, J. & Dowding, L. (2016) Leadership in health care. 3rd edition. London: Sage
- Chaudoir, S. R., L. G. Dugan and C. H. I. Barr (2013). "Systematic review factors affecting implementation of health innovations: a systematic review of structural, organizational, provider, patient, and innovation level measures." Implement Sci 8(22).
- Christensen, C.M, Bohmer, R. & Kenagy, J. (2000) Will disruptive innovations cure health care? Harvard Business Review Sept 103-111
- Dale, B., Van der Wiele,T., & Van Iwaarden, J. (2007) Managing Quality 5th ed FT/Prentice Hall
- Francis, R (2013) Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry Executive summary London: The Stationery Office https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/279124/0947.pdf
- Gopee, N. & Galloway, J. (2014) Leadership & management in healthcare. 2nd edition. London: Sage
- Jacobs, S. R., B. J. Weiner and A. C. Bunger (2014). "Context matters: measuring implementation climate among individuals and groups." Implement Sci 9: 46.
- Kotter, J.P (1995) Leading change: Why transformation efforts fail. Harvard Business Review March 59-67
- Kotter, J.P (1999) What Leaders Really Do. Boston, MA: Harvard Business Review Books
- Monitor (2013) Closing the NHS funding gap: how to get better value health care for patients https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/284044/ClosingTheGap091013.pdf
- Hawe, P. 2015. Lessons from complex interventions to improve health. Annu Rev Public Health, 36, 307-23.
- Hooper, A. & Potter, J. (2000) Intelligent Leadership. London: Random House Business Books
- Slack, N., Brandon-Jones, A., and Johnston R. (2011) Essentials of Operations Management, FT Prentice Hall.
Indicative learning resources - Web based and electronic resources
- ELE:
- Module ELE Page (https://vle.exeter.ac.uk/course/view.php?id=13713)
- CMH Postgraduate Programmes FAQs page (https://vle.exeter.ac.uk/course/view.php?id=7584)
- Master’s Level Learning Induction Course (https://vle.exeter.ac.uk/course/view.php?id=7584§ion=1)
- NIHR
- Library:
- Medicine LibGuides (https://libguides.exeter.ac.uk/MedicineHomePage)
- NIHR Learn– sign up with your Exeter email (https://www.nihr.ac.uk/health-and-care-professionals/learning-and-support/)
- Introduction to Research: https://learn.nihr.ac.uk/course/view.php?id=459
- Next Steps in Research: https://learn.nihr.ac.uk/enrol/index.php?id=682
- Getting into Research – Primary Care: https://learn.nihr.ac.uk/enrol/index.php?id=938
- Research Delivery e-learning Modules: https://learn.nihr.ac.uk/mod/page/view.php?id=9555
- Health Education England e-learning - Sign up with your Exeter email: https://populationwellbeingportal.e-lfh.org.uk/login
Indicative learning resources - Other resources
- Recorded lectures
| Credit value | 15 |
|---|---|
| Module ECTS | 7.5 |
| Module pre-requisites | None |
| Module co-requisites | HPDM149Z and HPDM151Z |
| NQF level (module) | 7 |
| Available as distance learning? | Yes |
| Origin date | 04/11/2021 |
| Last revision date | 27/04/2022 |
