PPI2015 Assignment Specifications

1. Introduction

Learning, teaching & assessment

The MSc in Clinical Trials has been designed to offer opportunities for personalised and applied learning wherever possible.  You will engage with key issues and concepts in clinical trials illustrated by case study examples and explore these further within your own professional context.  From the outset you will engage with the subject matter and one another through a series of individual and collaborative tasks that feed into the assessed work described in more detail in the following sections.

2. Assignment weighting

On this course, you are required to complete 4 assignments which contribute to your final grade. You are required to complete Individual Projects I and IV. IPs II and III give you two options from which you must choose one for each.

For Individual projects I, II and III, you need to relate the assignment to a real-life trial. This can be from your own practice setting or from the published literature.

IMPORTANT: Please note that IP IV, while it is the last assignment to be submitted, is based on your reflections throughout the course and it is very much to your advantage to begin reflecting in week 1. You will receive prompts to reflect on your learning in the form of ‘Your Turn’ activities in each unit and these reflections contribute to IP IV. You don’t only need to reflect in response to the prompts: you can write any reflections at any time if it would help you. Guidance on reflective writing and specific guidance on IPIV can be found here.

Please note:

• Late submissions cannot be accepted unless a formal request for an extension has been made to your personal tutor at least one week before the submission date. Acceptable reasons for a late submission request are health-related problems or a grievance in the family. 'Too much to do' or 'No time' are not acceptable reasons. You are expected to plan ahead to meet the course deadlines.
• Should you experience technical problems that prevent you from submitting your assignment to Turnitin on the due date, please notify the course leader immediately in an email including a screenshot of the error message and copy of your assignment as an attachment before the submission time/date.
• Remember to KEEP A COPY of your work at all times.
• The word count must be adhered to. Submitted assignments will be marked only up to the respective word count limit (+10% allowance). The word count does not include the title page or reference list. There is no lower limit as long as the assignment criteria have been met in full. Brevity and clarity of written material is a key principle of clinical trials and grant applications. The assignment word limits are enforced to help you improve your writing.
• NEW: Beginning Semester 2/2016 all assignments must be submitted to Turnitin as WORD docs (no PDFs). In addition, any tables or figures may not be embedded as images into the final document. Please be reminded that the word count only excludes the title page and the reference list.

3. Learning outcomes

1. Critically appraise the theory and key principles of patient and public involvement in clinical research
2. Critically assess their own practice/place of work in relation to the level of patient and public involvement in research
3. Evaluate the barriers to effective patient involvement and strategies and techniques to overcome such barriers 
4. Design a patient and public involvement strategy for a clinical trial
5. Demonstrate the skills to explain the role of patient involvement in a clinical trial to a lay person
6. Demonstrate understanding of the role of public engagement in clinical trials

4. Individual project I

Overview

This assignment asks you to apply your learning on patient and public involvement to a real-life clinical trial.  You may choose a trial you know from your own practice setting, or choose one from the published literature. You should demonstrate that you understand the purpose and process of patient and public involvement in a clinical trial and that you can identify the most appropriate methods of involvement for the specific study you choose.

Details

Design a patient and public involvement strategy for a clinical trial from initial idea to conclusion/dissemination. This should include:

• the rationale for involving patients/the public (i.e. the anticipated benefits of involving patients/the public in this particular trial)
• a description of appropriate methods of involvement throughout the research process
• who you wish to involve and how you will identify them
• how you will evaluate the involvement
• a brief statement of costs

4.1. Learning outcomes

4. Design a patient and public involvement strategy for a clinical trial.

4.2. General format

Your Individual project I submission should include a title page containing:

• The words ‘Individual project I submission for PPI course’
• Your UUN number (NOT your name)
• The words ‘ University of Edinburgh 2015/16 Semester 2’
• The word count

Your submission should be no longer than 800 words in length (Font 10-12. typed, single spacing fine) plus the bibliography (citations in Vancouver or Harvard style).

4.3. Grading criteria

Your work will be assessed to give you a final mark out of 100 as tabled below:

4.4. Indicative reading & resources

• INVOLVE. Briefing notes for researchers. 2012. INVOLVE, Eastleigh.
  • Available at:www.invo.org.uk/resource-centre/resource-for-researchers/
• INVOLVE. Public involvement in clinical trials: Supplement to the briefing notes for researchers. 2012. INVOLVE, Eastleigh.
  • Available at: http://www.invo.org.uk/wp-content/uploads/documents/INVOLVEpublicinvolvementinclinicaltrialsBriefingnotes2012.pdf
• Wright D, Foster C, Amir Z et al. Critical appraisal guidelines for assessing the quality and impact of user involvement in research. Health Expectations 201; 13: 359–368.
  • Available at http://onlinelibrary.wiley.com/doi/10.1111/j.1369-7625.2010.00607.x/epdf

4.5. Submission date and procedures

Your Individual project I is due by midnight (GMT) Friday, February 12 2016 to the IP I Turnitin dropbox.

Note:

• Should you experience technical problems that prevent you from submitting your assignment to Turnitin on the due date, please notify the course leader immediately in an email including a screenshot of the error message and copy of your assignment as an attachment before the submission time/date.
• Remember to KEEP A COPY of your work at all times.

5. Individual project II

Overview 

In this assignment, you have the opportunity to put your learning into practice in a different way. It assesses your skills in explaining patient and public involvement to lay people so that they will want to get involved in your research. You can choose either a verbal format in the form of a video, or a written/pictorial format in the form of a poster. For both options, choose a real life trial, either from your own practice or the published literature. This means you will be tailoring your video or poster to the requirements of a specific trial, rather than talking about general principles.

Details

You must complete one of these options

1. Video record yourself talking to a patient/member of the public (or a group of lay people) to explain patient and public involvement in a clinical trial, answering their questions and asking them to get involved.

OR

2. Create a poster to appeal to patients to come forward to advise on a clinical trial. This should include information about why you want them to help; what you want their advice on; how they can contribute (e.g. attending meetings, phone calls, email); how they can contact you. It should also be visually appealing/interesting.

5.1. Learning outcomes

4. Design a patient and public involvement strategy for a clinical trial.

5.2. General format

Option 1: Video

You can record your video using the PoodLL feature in Moodle.

Launch PoodLL here

PoodLL guidance is available here PoodLL guidance

It is suggested that you approach this as a role play, where you talk to either one person or group of people – these may be colleagues, friends – if you want to talk to real patients, this may be possible but you will need to be mindful of ethical issues, so it is best to discuss this with your course leader.

You will need to include an explanation of the trial; why you want to involve them and how; details of how you will organise their involvement; the time commitment. You can also give them the opportunity to ask questions and record any discussion.

Aim for a recording lasting approximately 10 minutes. We also require an accurate transcript of the video discussion; aim for around 1000 words - this is only a guideline and can be more if need be.

Your Individual project II submission should include a title page containing:

• The words "Individual project II submission for PPI course - video transcript"
• Your UUN number (NOT your name)
• The words "University of Edinburgh 2015/16 Semester 2"
• The word count

Your submission should be around 1000 words in length - this is only a guideline and can be more if need be (Font 10-12. typed, single spacing fine).

Option 2: Poster

Prepare your poster using Powerpoint. The poster should provide both a clear, concise explanation about what the patient and public opportunity is for getting involved with the trial and also be visually appealing. Take care not to include too much text and make sure the language is easily understood by lay people.

You will need to include some information about:

• the trial
• who is conducting it
• what the patients/members of the public will be required to do and why
• what the time commitment is for them and where they find out more information.

Your Individual project II submission should include a title page containing:

• The words "Individual project II submission for PPI course - poster"
• Your UUN number (NOT your name)
• The words "University of Edinburgh 2015/16 Semester 2"
• The word count

Your submission should be no longer than 1000 words in length.

5.3. Grading criteria

Your Individual project II will be assessed to give you a final mark out of 100 against the following criteria:

Option 1: Video

Option 2: Poster

5.4. Indicative readings & resources

Option 1: Video

Follow the PoodLL instructions listed here

Option 2: Poster

Refer to the IP I assignment in PCTM where you were asked to evaluate a poster presented to the ECTU conference in Edinburgh. Review the guidance given there and the feedback to your submitted assignment to remind yourself of the features of a good poster. See the PCTM2014 IP I assignment specifications here: https://www.moodle.is.ed.ac.uk/mod/book/view.php?id=14016&chapterid=1599

You can find guidance on preparing a poster here, but remember, your audience for this task is patients, not academics (you will need to log into EASE to access the guidance): https://www.wiki.ed.ac.uk/pages/viewpage.action?title=Designing+an+academic+poster&spaceKey=HowTowiki

Also the University of Leicester has created an online tutorial on designing a poster (Remember your audience for this task is patients, not academics).

Available at https://connect.le.ac.uk/posters

5.5. Submission date & procedures

Your Individual project II is due by midnight (GMT) Friday, March 11 2016. The poster should be submitted as a Powerpoint file to the IPII Turnitin dropbox - Poster.  The video transcript should be submitted to the IPII Turnitin dropbox - Video; and the video should be uploaded to PoodLL. 

Note:

• Should you experience technical problems that prevent you from submitting your assignment to Turnitin or PoodLL on the due date, please notify the course leader immediately in an email including a screenshot of the error message and copy of your assignment as an attachment before the submission time/date.
• Remember to KEEP A COPY of your work at all times.

6. Individual project III

Overview

You have a choice whether to undertake a critical evaluation of the theoretical underpinnings of patient and public involvement in research and their practical applications OR to design a public engagement strategy for a clinical trials unit.

Details

You must complete one of these options

1. Critically evaluate the theory and practice of patient and public involvement in healthcare research and make recommendations for addressing the ‘evidence of benefit’ gap.

OR

2.  Design a public engagement strategy for your workplace. This should include:

• the rationale for public engagement
• who you want to engage and why
• methods of engagement
• who will contribute
• how you will evaluate the engagement.

6.1. Key features

Option 1: Critical evaluation

For this assignment, you are required to critically evaluate the field of patient and public involvement in research. You should demonstrate reading and thought that goes beyond the lectures in this course. You should address both the theoretical underpinnings and the practical application of patient and public involvement in healthcare research. You should identify where/how there are gaps in demonstrating the impact of patient and public involvement in research and suggest how these gaps might be filled. You may, if you wish, make your evaluation specific to your own country: critically evaluate how the patient and public involvement agenda applies in your own healthcare setting.

Option 2: Public engagement strategy

For this assignment, you will design a public engagement strategy for your own place of work. You should describe your workplace briefly. Indicate why you want to engage the public:

• who exactly do you want to communicate with
• what do you want them to understand about your work and why?
• What benefits do you anticipate from engaging the public?
• Are there any difficulties?
• What methods will you use, who will contribute to the engagement process, what resources will you need?
• How will you evaluate the engagement, what criteria will you use?

NB This assignment is about public engagement, not involvement.

6.2. Learning outcomes

Option 1: Critical evaluation

1. Critically appraise the theory and key principles of patient and public involvement in clinical research.

Option 2: Public engagement strategy

6. Demonstrate understanding of the role of public engagement in clinical trials

6.3. General format

Option 1: Critical evaluation

Your Individual project III submission should include a title page containing:

• The words ‘Individual project III submission for PPI course: option 1’
• Your UUN number (NOT your name)
• The words ‘ University of Edinburgh 2015/16 Semester 2’
  
• Word count

Your submission should be no longer than 1000 words in length (Font 10-12. typed, single spacing fine) plus the bibliography (citations in Vancouver or Harvard style).

Option 2: Public engagement strategy

Your Individual project III submission should include a title page containing:

• The words ‘Individual project III submission for PPI course: option 2’
• Your UUN number (NOT your name)
• The words ‘ University of Edinburgh 2015/16 Semester 2’
  
• Word count

Your submission should be no longer than 1000 words in length (Font 10-12. typed, single spacing fine) plus the bibliography (citations in Vancouver or Harvard style).

6.4. Grading criteria

Your Individual project III will be assessed to give you a final mark out of 100 against the following criteria:

Option 1: Critical evaluation

Option 2: Public engagement strategy

6.5. Indicative reading & resources

Option 1: Critical evaluation

• Brett J, Staniszewska S, Mockford C, Herron-Marx S, Hughes J, Tysall C, Suleman R. Mapping the impact of patient and public involvement on health and social care research: a systematic review. Health Expectations 2012; doi: 10.1111/j.1369-7625.2012.00795.x
  • Available online http://onlinelibrary.wiley.com/doi/10.1111/j.1369-7625.2012.00795.x/pdf
• Edelman N, Barron D. Evaluation of public involvement in research: time for a major re-think? J Health Serv Res Policy 2015; OnlineFirst, doi:10.1177/1355819615612510
  • Available online http://hsr.sagepub.com/content/early/2015/10/27/1355819615612510.full.pdf+html

Option 2: Public engagement strategy

• Devonshire IM, Hathway G. Overcoming the barriers to greater public engagement. PLoS Biol 2014; 12(1): e1001761. doi:10.1371/journal.pbio.1001761
  • Available at https://docs.com/plosbiology/9428/overcoming-the-barriers-to-greater-public
• Duncan S, Spicer S. The Engaging Researcher. Vitae 2010.
  • Available at www.vitae.ac.uk/researcherbooklets
    

6.6. Submission date & procedures

Your Individual project III is due by midnight (GMT) Friday, March 18 2016 to the IP III Turnitin dropbox.

Note:

• Should you experience technical problems that prevent you from submitting your assignment to Turnitin on the due date, please notify the course leader immediately in an email including a screenshot of the error message and copy of your assignment as an attachment before the submission time/date.
• Remember to KEEP A COPY of your work at all times.

7. Individual project IV

Overview

For this assignment you are expected to reflect on your learning experience and question your learning and development. Your reflections throughout the course will help you to chart how your thinking progresses.  You will receive specific prompts throughout the course to reflect on your learning from each Unit and its application to your own practice. You will also have the opportunity to discuss your reflections in an online tutorial with your peers and the course leader. In addition, you may submit your reflections in Pebble+ to the course leader at the end of week 4 in order to receive formative feedback. This is not compulsory and marks will not be deducted if you don’t, but it is designed to be helpful in completing your assignment and you are advised to take advantage of the opportunity.

Details

For this assignment you need to write a narrative with supporting appendix reflecting on your personal academic and professional development as the course has progressed in relation to the following themes:

• Your knowledge of and attitude to patient and public involvement in research
• Your perceptions of how the course content relates to your own practice, including barriers to implementing patient and public involvement and how these might be overcome
• How you understand the theory and practice of patient and public involvement in research
• If/how, your thinking about patient and public involvement has changed during the course and what influenced this

Essentially, you are trying to demonstrate how you have monitored and enhanced your learning as a course participant through critical reflections on patient and public involvement in research and your response to it.

The 1500-word narrative should provide a reflective evaluation of your personal academic and professional development.

You should present extracts from your reflective diary to illustrate specific points, but the assignment should take a broader perspective where you look back and evaluate how your perceptions of patient and public involvement in research developed as you learned more and engaged in discussion with the expert lecturers, tutors and your peers during the course. You may also want to reflect on any discussions you had on the topic with clinical colleagues or patients.

You will find more detailed advice and guidance on IP IV in the reflective writing guide here.

7.1. Additional guidance

Reflective writing guidance

The purpose of this guide is to provide further information on the Reflective writing Assignment, IP IV, which contributes towards the final marks for the course, Patient and Public Involvement. 

Reflective writing assignment

The Patient and Public Involvement course has presented you with new ideas and new ways of thinking about conducting research. You have been challenged throughout to think about your own values and apply your learning to practice. During the course, you were prompted to reflect on your learning through reflective ‘Your Turn’ activities (see Appendix 1), which should give you the basic material to illustrate your narrative in IP IV.

For this assignment you need to write a narrative reflecting on your personal academic and professional development as the course has progressed in relation to the following themes:

• Your knowledge of and attitude to patient and public involvement in research
• Your perceptions of how the course content relates to your own practice, including barriers to implementing patient and public involvement and how these might be overcome
• How you understand the theory and practice of patient and public involvement in research
• If/how, your thinking about patient and public involvement has changed during the course and what influenced this

Essentially, you are trying to demonstrate how you have monitored and enhanced your learning as a course participant through critical reflections on patient and public involvement in research and your response to it.

The 1500-word narrative should provide a reflective evaluation of your personal academic and professional development. As a general guide, you should aim to write approximately 300 words per theme, but if some themes are more relevant than others to you personally, you may want to use more words for these – but please justify your approach in the introduction to your paper.

You should engage with each of the four themes above, and you should include illustrative extracts from your reflections (as entered in in Pebble+ throughout the course) to support what you say in the narrative. These extracts will sit in the appendix of your assignment, do not contribute to the word count and will not be marked on spelling, grammar etc. You should cross-reference the extracts in the main body of your narrative to make it clear which extracts support which statements you make. You don’t necessarily need to draw on all the ‘Your Turn’ reflections for IP IV, but as a general guide, you should draw on at least 4 of your weekly reflections in your narrative.

You should conclude with an evaluation of your learning against the learning outcomes for the course and the graduate attributes you feel you have reached (or not), and the consequence/s of this.

7.2. Additional guidance continued

Reflective writing guidance

Reflection on your learning requires you to be self-aware in the critical examination of yourself and your feelings. You should be open about any difficulties you found in understanding the concepts and applying them in practice as well as candid about any disagreements you have with the idea of patient and public involvement in research. If you are enthused and inspired to change something in your practice, do discuss that.

A critical approach involves more than being self-critical: it includes positive reflections on your own strengths. In reflective writing, there is no right and wrong viewpoint. Whether your perceptions are positive or negative (or a mixture), it is important to be honest and you will not gain or lose marks by being for or against patient and public involvement or by struggling with the concepts and applicability to your own work, as long as you justify your stance. Your reflection should involve examining your feelings about the topic and its application in practice and critically evaluating your learning process. Gibbs’ (1988) model of reflection offers a structured approach to reflection which we recommend you use to guide your reflective assignment:

Gibbs’ (1988) Model of Reflection

[Page 10 and 11 in QMU’s Guide to reflection (at the bottom of the webpage here: http://www.qmu.ac.uk/eportfolio/reflect.htm) describes each stage in more detail.] When writing your narratives, try to think along the lines of Gibbs’ cycle of reflection and ask yourself the following questions at each of Gibbs’ 5 stages:

1. Description: What theme are you discussing and what activities (e.g. lectures, tutorials, reading, discussions with other people, thinking about your workplace) are you referring to? Give a concise account.
2. Feelings: What were you thinking and feeling about patient and public involvement at key points during the course? What was affecting your feelings? How do you feel now?
3. Evaluation: This is the essence of IP IV. What was easy/difficult, challenging/inspiring? Why? What factors impacted on your understanding of patient and public involvement and how? How do you feel about the experience now?
4. Analysis: What sense can you make of the experience?
5. Conclusion: What have you learned? What is your experience of reflection throughout the course? How did reflection contribute to meeting the learning outcomes (or not)?
6. Action Plan: This may not be relevant to all of you, but if you plan to undertake patient involvement activities, summarise briefly what more you need to know/do to make it work.

Make your writing explanatory, not descriptive, i.e. why, not just what. Remember, simply reviewing what happened does not constitute reflective writing. Reflection is the process of interrogating the experience with searching questions.

In the supporting appendix include extracts from your reflections throughout the course or posts to the Thought discussion boards.

Tips:

1. This reflective writing assignment will take you longer than anticipated so please, please don’t leave it until the last minute. That said, it should be a rewarding experience to catalogue your development as a professional…. 
2. It will help you greatly if you reflect as close to an event as possible rather than trying to remember how you felt 6 weeks later. You are therefore strongly encouraged to reflect regularly. Pebble+ records the dates of your entries and a few marks will be awarded in IP IV for timely and regular reflective entries
3. Remember, you are given the opportunity to submit your reflections in Pebble+ to the course leader in week 4 so you can receive formative feedback on how you are approaching reflective writing.

References

• Gibbs, G (1988). Learning by doing. FEU publishers
  • Available from http://www2.glos.ac.uk/gdn/gibbs/index.htm
• Excerpt from PDP paper 4, Reflection in higher education learning by J. Moon (2001)
  • Available from Reflection in HE learning (PDF)
• Somerville, D., Keeling, J., A practical approach to promote reflective practice within nursing. Nursing Times. 2004 March 20;100(12).
  • Available from A practical approach to reflection (PDF)

7.3. Learning outcomes

1. Critically appraise the theory and key principles of patient and public involvement in clinical research
2. Critically assess your own practice/place of work in relation to the level of patient and public involvement in research
3. Evaluate the barriers to effective patient involvement and strategies and techniques to overcome such barriers

7.4. General format

Your Individual project IV submission should include a title page containing:

• The words ‘Individual project IV submission for PPI course’
• Your UUN number (NOT your name)
• The words ‘ University of Edinburgh 2015/16 Semester 2’
• Word count

Your submission should be no longer than 1500 words in length (Font 10-12. typed, single spacing fine) plus the appendix and bibliography (citations in Vancouver or Harvard style).

7.5. Grading criteria

Your work will be assessed to give you a final mark out of 100 as tabled below:

7.6. Indicative reading & resources

• Gibbs, G (1988). Learning by doing. FEU Publications
  • Available from http://www2.glos.ac.uk/gdn/gibbs/index.htm
• Excerpt from PDP paper 4, Reflection in higher education learning by J. Moon (2001)
  • Available from Reflection in HE learning (PDF)
• Somerville, D., Keeling, J., A practical approach to promote reflective practice within nursing. Nursing Times. 2004 March 20;100(12).
  • Available from A practical approach to reflection (PDF)

7.7. Submission date & procedures

Your Individual project IV is due by midnight (GMT) Friday, March 25 2016 to the IP IV Turnitin dropbox.

Note:

• Should you experience technical problems that prevent you from submitting your assignment to Turnitin on the due date, please notify the course leader immediately in an email including a screenshot of the error message and copy of your assignment as an attachment before the submission time/date.
• Remember to KEEP A COPY of your work at all times.

8. Overview

I. Overview of the assessed course assignments

9. Marking scale

For each of the assessed course assignments please be aware that the mark awarded is provisional. Be sure you understand the following:

The marks awarded for assessed assignments in Patient and Public Involvement are provisional and are provided to give you an indication of your progress ahead of the course concluding. 

At the end of the course, the quality of all your coursework will be assessed to provide a final grade on the scale provided below. Your final grade is provisional until discussed and passed by the exam board in August of any academic year.