Developing Your Research Plan (SoHP503 Project, 2025) PDF

Developing your Research Plan: an overview of key methodological and ethical considerations SoHP503 Project studies Professor Jenny Freeman This lecture is being recorded as part of the University of Plymouth's Content Capture project and will be available via the Panopto block located on your modu...

Developing your Research Plan: an overview of key methodological and ethical considerations SoHP503 Project studies Professor Jenny Freeman This lecture is being recorded as part of the University of Plymouth's Content Capture project and will be available via the Panopto block located on your module DLE pages shortly. Please note - If you ask a question or make a comment it may appear on the recording, you can ask me to pause the recording if you do not wish your question to be recorded. To register your attendance use one time –code : 15/01/2025 SoHP503 Prof Freeman 2 What does this session aim to cover? Aim: To provide an overview of how to plan your research project, considering ethical issues Objectives: Revisit what you have done so far in thinking about your research project Outline key ethical principles Discuss key methodological issues to consider when planning your project Promote discussion on ethical issues; with application to your own project Provide examples from a range of previous projects Provide a structured overview for planning your research project Detail definitions of success of your research project 15/01/2025 SoHP503 Prof Freeman 3 What have you done so far? Chosen your study topic, and are clear about the aim Had a session on how to undertake a comprehensive literature search What has already been done Gaps in the research – demonstrating a need for the study Where your project fits Refined your thoughts into a specific research question(s) using available frameworks (eg PICO, SPIDER) Defined the specific issues/ specific questions you want to address Revisited and refined your aim and objectives 15/01/2025 SoHP503 Prof Freeman 4 Activity (5 minutes) Write down: Your study topic What have you learnt based on your comprehensive literature search? What has already been done What are the gaps in the research? Where does your project fit into this? What is your specific research question What are your aim(s) and objectives 15/01/2025 SoHP503 Prof Freeman 5  Confident about these? Now you need a clear Plan To show that your research is relevant, feasible, rigorous 15/01/2025 6 and ethical SoHP503 Prof Freeman Steps in any research study Clear research question: aims and objectives Decide upon study approach and design Identify target population Recruit participants into study Collect data on them Store the data Analyse the data Write up the results and share your findings 15/01/2025 SoHP503 Prof Freeman 7 Project question is not focused or well defined, project not workable within your time frame, inadequate plan for dealing with each one of the required research steps, poor team communication. 15/01/2025 SoHP503 Prof Freeman 8 Specifics of the project Remember the purpose of the research project is to answer your research question - keep focused Specifics include: WHAT is your research question, aims and objectives WHO (target population: inclusion and exclusion criteria) WHERE (setting) WHEN (assessments / data collection) HOW (study design, recruitment process, data collection methods, data storage, data analysis, interpretation and reporting results) Clearly rationalising the choices you make, i.e. WHY 15/01/2025 SoHP503 Prof Freeman 9 Integral to this is consideration of ethical issues What do we mean by ethics? Human character and conduct, morals and rules of behaviour. Critical evaluation about norms, values, right and wrong, what ought and ought not to be done ….. in research: Governs the standards of conduct of research being undertaken Is the responsibility of all involved: researchers, research institutions, ethics review committees and regulatory bodies. 15/01/2025 SoHP503 Prof Freeman 10  Key Ethical Principles in Research Respect for Persons: Recognition of the personal dignity and autonomy of individuals Non-Maleficence: Intend to do no harm Beneficence: Intend to benefit Justice: Distribution of ability to participate in the research, the burdens of research and who receives the benefits 15/01/2025 SoHP503 Prof Freeman 11 Ethical principle Examples in research Respect for Voluntarily participate – not coerced dignity and Know what is involved - informed consent autonomy Non- Intervention doesn’t intend to harm (physical, maleficence emotional), risks minimised Study not too burdensome (eg not too many assessments) Signposted to support resources if potentially distressing Beneficence Interventions may provide benefit Knowledge gained on the topic (dependent on a good study design) Justice Robust ethical review Fair chance to participate in the study (how identified, approached, inclusion criteria) Random 15/01/2025 allocation to SoHP503 interventions Prof Freeman 12 No impact if choose not to participate (eg student  Key Ethical Principles in Research Respect for Persons: Recognition of the personal dignity and autonomy of individuals Non-Maleficence: Intend to do no harm Activity Task: Beneficence: Spend 3 minutes bullet pointing in the table on the next slide research Intend to benefit issues that may be relevant within these key categories (specific to Justice: your own project where possible) Distribution of ability to participate in the research, the burdens of research and who receives the benefits 15/01/2025 SoHP503 Prof Freeman 13 Ethical principle Issues that might be relevant in your own research Respect for dignity and autonomy Non- maleficence Beneficence Justice 15/01/2025 SoHP503 Prof Freeman 14 Always be mindful of these ethical issues during your design process Any study collecting data from people requires ethics approval This involves review by an Ethics Committee Research question, aims and objectives Study design Outlining ethical issues Clearly describing how you have addressed ethical issues Without ethical approval you cannot undertake the study 15/01/2025 SoHP503 Prof Freeman 15 WHO Ethical issues: justice, beneficence Who is you target population? Specific inclusion and exclusion criteria How many people do you intend to recruit? Inclusion criteria Exclusion criteria People registered with No access to a videoconferencing device University of the Third Age Medical conditions that preclude participation such who are 50 years and older as, serious cardiac or neurological disease and who complain of A shoulder fracture/arthroplasty within the previous shoulder pain, weakness or six-months stiffness. Unable to actively move their shoulder independently Visual impairments that preclude participation in a video conferencing assessment Example from Physiotherapy project “Reliability of the Shoulder Telehealth Assessment Tool via Video Conferencing for Shoulder Assessment in Adults over 50 years of Age. 15/01/2025 SoHP503 Prof Freeman 16 Inclusivity in research What is meant by inclusivity? Research that intentionally involves people who have first-hand experience with the topic being studied, taking into account race, ethnicity, gender, age, etc. Why does it matter? A lack of diversity impedes our ability to generalize study results, limits medical advancements of effective therapies, and prevents some populations from experiencing the benefits of research innovations and receiving high quality care. Do you think this always happens - examples please? How can you promote inclusivity in your research? 15/01/2025 SoHP503 Prof Freeman 17  15/01/2025 SoHP503 Prof Freeman 18 Slide from CSP “Health Inequity Report, Sept  Ethical Issues: Justice, Respect 15/01/2025 SoHP503 Prof Freeman for dignity and autonomy 19 HOW: Study design Ethical Issues: beneficence, justice Wide range of study designs - choose which one best answers your question Examples: Surveys Interviews: focus group or one-to-one Laboratory based RCTs Observational studies Systematic Reviews 15/01/2025 SoHP503 Prof Freeman 20  Activity: What research approach and study design might be appropriate for the following questions? Study question Relevant research approaches and study designs What is the patient experience of attending the University Optometry Clinic? What are the physical demands of walking football on people with a diagnosis of Parkinsons disease? Are there kinematic and kinetic differences between barefoot walking and barefoot with an orthotic walking in healthy adults? What are student paramedic views on ambulance delays and their impact on clinical exposure and confidence? What are the most accurate clinical assessments, available to paramedics, for identifying mild-moderate traumatic brain injuries? What is the meaning of cold water swimming in the UK as an occupation What is the accuracy and precision of self-tonometry with the SoHP503 Prof Freeman 15/01/2025 21 iCare Home instrument (vision instrument). HOW: Participant Recruitment How do you make people aware of the study and invite them to participate: Ethical issues: - Respect for persons: openness and honesty, sufficient detail, not coercive - Justice: fairness in participation, inclusivity 15/01/2025 SoHP503 Prof Freeman 22  Example of FELLOW Recruitment STUDENTS Poster We need you to participate in this research project otherwise we will fail! What elements are wrong with this recruitment poster? Free drinks to volunteers Personal phone numbers and email addresses → 15/01/2025 SoHP503 Prof Freeman 23 Participant recruitment Informed Consent/Voluntary participation (Ethical issues: respect for dignity and autonomy) Informed Consent must be obtained before recruiting subjects into a research project. Consent should be given voluntarily. Participants should not be coerced or bribed to enter, or remain in the study. A consent form should be signed and witnessed. Assessed by Ethics Committee through scrutiny of: o Consent forms o Advertisements for recruitment o Participant information sheets o Letters of invitation to participants (often via gatekeeper) 15/01/2025 SoHP503 Prof Freeman 24 Example of Consent form 15/01/2025 SoHP503 Prof Freeman 25  Participant Information Sheet Ethical issues: Respect for dignity and autonomy, Openness and honesty Subjects be fully informed of the research aims and potential benefits and harm. They should be informed about what they will have to do if they participate through a Participant Information Sheet Extract from PIS from Dietary study SoHP503 Prof Freeman 26 15/01/2025  WHAT: “information do you need to collect” All studies: Demographics and diagnostics Quantitative studies Standardised Measures: objective or self-report (with knowledge of their validity and reliability) Qualitative Pre-determined interview questions / interview schedule (structured, semi- structured, unstructured) Surveys Robust surveys which have been piloted on intended audience ……….And when/how often do you need to collect this data? 15/01/2025 SoHP503 Prof Freeman 27 Activity: What type of information could be collected? Ethics issues: non-maleficence, beneficence, dignity Demographic information? Diagnostic information? Other data? In A study measuring falls in people with stroke? A study measuring student confidence with knowledge on a And topic? when might you collect this data? Justify your decisions. 15/01/2025 SoHP503 Prof Freeman 28 15/01/2025 SoHP503 Prof Freeman 29  Collecting the information Ethics issues: beneficence, justice To ensure reliable and trustworthy information: A written “recipe”(protocol): What – standardized measures? interview schedules ? survey? Where – face-to-face or remotely?, training needed? Online survey? At lectures? When – if students consider when are clinical placements? Exams? Holidays? By whom – everyone in research team? or specific people to optimize reliability? USE MENTAL IMAGERY ABOUT WHAT YOU WILL DO: STEP BY STEP BY STEP 15/01/2025 SoHP503 Prof Freeman 30 HOW: ensuring safe procedures during data collection Ethics issues: non maleficence, justice No project is free from risk. All studies must include a risk assessment form where risks are considered, and strategies are put in place to mitigate as much risk as possible. 15/01/2025 SoHP503 Prof Freeman 31 Confidentiality and data protection is essential at every step General Data Protection Regulations 2018 https://www.youtube.com/watch?v=j6wwBqfSk-o Key issues to consider: Confidentiality of research participants must be preserved. Identities should not be identifiable in research reports. Data should be coded and unique ID assigned. All data to be stored on Onedrive folders, set up by your supervisors, and with access restricted to research team 15/01/2025 SoHP503 Prof Freeman 32  Confidentiality & Data Protection General Data Protection Regulations 2018 https://www.youtube.com/watch?v=j6wwBqfSk-o Key issues to consider: Confidentiality of research participants must be preserved. Identities should not be identifiable in research reports. Data should be coded and unique ID assigned. All data to be stored in locked cabinets, with authorised access. Assessed by Ethics Committee through scrutiny of: o PEOS application - detail provided as to how you comply with GDPR, including how data will be stored, who will have access to your data, and how anonymity and confidentiality will be safeguarded o Consent forms o Participant information sheets SoHP503 Research Plan and Ethical considerations 15/01/2025 | J SoHP503 Freeman Prof Freeman 33 Example of Risk Assessment form Extract from a section of the Risk Assessment form, Undergraduate Telerehab Shoulder Project 34 HOW: do you analyse your results Ethical issues: Justice, Beneficence Needs to be driven by your aim, objectives and methods Quantitative studies: hypothesis (where appropriate) and analysis plan set a priori (ie now!)  Descriptive statistics  Inferential statistics (the statistical test(s) you are planning to use and why)  Level of statistical significance Qualitative studies: Approach  eg thematic analysis. Systematic Review studies:  How you will synthesise the information 15/01/2025 SoHP503 Prof Freeman 35 Why at every step of the process 15/01/2025 SoHP503 Prof Freeman 36 Plan the timeline of your study from start to finish Gannt chart example 2024 2025 15/01/2025 SoHP503 Prof Freeman 37 Definition of success 1. Appropriate deign of study, which allows you to answer the questions you have posed 2. Submission and approval of ethics application (clear protocol that has described ethical issues and how these will be managed/ mitigated) 3. Successful recruitment of participants into your study (target number recruited) 4. Data collected – minimal missing data, available to you in a format that allows you to analyse the data effectively 5. Robust analysis (eg using statistics, or qualitative analysis) 6. Clear summary available to your participants in lay language 7. Submission of your assignment, and pass 8. Publication/ presentation at a conference as relevant to enable dissemination of your findings 15/01/2025 SoHP503 Prof Research SoHP503 38 Freeman Plan and Ethical considerations | J Freeman Disseminating the results: student Assignment examples Conference posters Published articles Conference talks 15/01/2025 SoHP503 Prof Freeman 39 Any questions 15/01/2025 SoHP503 Prof Freeman 40 Please use the discussion board in case of questions. Thank you! Thanks 