Mental Health Research Protocols PDF

**[1. Core Principles of Mental Health Research]** Formative: - October 14^th^ - December 9^th^ Summative: - November 11^th^ (coursework) - January 20^th^ (coursework) - January 13^th^ (MCQ) FINER Criteria - Feasibility - Adequate number of subjects - Adequate tech...

**[1. Core Principles of Mental Health Research]** Formative: - October 14^th^ - December 9^th^ Summative: - November 11^th^ (coursework) - January 20^th^ (coursework) - January 13^th^ (MCQ) FINER Criteria - Feasibility - Adequate number of subjects - Adequate technical expertise - Affordable in time and money - Manageable in scope - Interesting - Getting the answer intrigues investigator, peers and community - Novel - Confirms, refutes or extends previous findings - Ethical - Amenable to a study that institutional review board will approve - Relevant - To scientific knowledge - To clinical and health policy - To future research PICOT Criteria: - Population (patients) - What specific patient population are you interested in? - Intervention (for intervention studies only) - What is your investigational intervention? - Comparison Group - What is the main alternative to compare with the intervention? - Outcome of interest - What do you intend to accomplish, measure, improve or affect? - Time - What is the appropriate follow-up time to assess outcome [Origins Of Research Questions: ///] - Personal interest/experience, clinical observation and inspiration - EVIDENCE - Immersion in literature is key to refining a question - Systematic literature review required for major studies - Incremental progress -- most studies are logical next stop in gradual process of developing evidence - "Replications": often useful, especially with better methods/different group - THEORIES - Should be able to formulate potential pathways underpinning associations you think you may find or interventions that might work - Stakeholder Views - What do service users and carers think is important? [Main Types of Mental Health Research Question Covered in Module?] 1. Aetiology & Mechanisms: To understand how and why mental health problems arise and develop (neuroscience, psychological & epidemiological approaches) 2. Treatment: to develop and test means of preventing or alleviating mental health problems (trials & other evaluations) 3. Experiences: To understand what it is like to have a mental health problem in a variety of context and what impact societal responses have (qualitative research, PPI) [Structure of Protocol: ] - **Introduction**: Context, Current Evidence and Rationale - why and what: why the research needs to be done and what will be its relevance? The magnitude, frequency, affected geographical areas, ethnic and gender considerations, etc of the problem should be followed by a brief description of the most relevant studies published on the subject. - **Aims & Objectives:** including main research question and, where relevant, hypothesis - **Methods:** - Setting - Sample - Measures - Interventions - Procedures - Analysis Plan - Dissemination Plan [Aims, Objectives & Hypotheses:] - Aim: overall purposes, including the main research question to be examined - Objectives: tasks to be accomplished - Hypotheses: testable hypotheses need to be specified unless study is qualitative or purely descriptive - Hypothesis is a possible solution to a research question, to be tested in the research study. Based on previous evidence & theoretical assumptions about phenomena being investigated - Should be formulated so that you can clearly say at the end of the study whether supported -- so needs to be very specific - Qualitative and Descriptive studies need clear questions if not hypotheses [Analysis Plan:] - Must be written in advance - In quantitative studies specifically: - Which main descriptions or comparisons are to be presented, stating which are primary and which secondary? - Which statistical tests to be used for the analyses - In qualitative studies: - Approach to be taken to data collection, e.g., thematic analysis aimed at identifying main themes, analysis based on grounded theory - Tools to be used e.g., software packages [Dissemination Plans:] - To other researchers e.g., via academic papers, conference presentations, relevant blogs, twitter - To relevant clinicians, service planners, policy makers: seeking meetings, sending information to relevant individuals, professional publications, blogs, twitter - To service users, carers, the public: open meetings, short summaries for participants, relevant charities, media and social media [Public and Patient Involvement (PPI): ] - Increasingly key in clinical research -- herd to be funded without it - Stakeholders in research may be service users, carers, clinicians, service planners and policy makers, public - Involvement may include defining research questions, reviewing protocols and instruments, assessing ethics applications, interpreting, and disseminating results. - Service users may now be involved in all stages of research including collecting and analysing data [Other Information in Protocol:] - Time and staff required - Investigator roles - Costs - Implications for the NHS, including impacts on outcomes and costs - Timelines and Milestones (Gant Chart or similar usually included)