Leadership and management of clinical trials in creative arts therapy / / Felicity Anne Baker

• Autore: Baker Felicity Anne
• Pubblicazione: Cham, Switzerland : , : Palgrave Macmillan, , [2022]; ©2022
• Descrizione fisica: 1 online resource (301 pages)
• Disciplina: 616.891656
• Soggetto topico: Art therapy; Teràpia artística; Assaigs clínics
• Soggetto genere / forma: Llibres electrònics
• Note generali: Includes index.
• Nota di contenuto: Intro -- Foreword -- Preface -- Acknowledgements -- Contents -- About the Author -- List of Figures -- List of Tables -- 1 Introduction -- Implementing Robust Creative Arts Therapies Trials -- Sharing Wisdom and Capacity Building -- So You Won The Grant, Now What? -- Past and Current Projects -- Study 1. Music Therapy to Aid Non-invasive Ventilation Transition for People with Motor Neuron Disease (2014-2015) -- Study 2. Singing My Story: Negotiating Identities Through Therapeutic Songwriting for People with Neurological Injuries (2015-2017) -- Study 3. MIDDEL: Music Interventions for Dementia and Depression in Elderly Care-The Australian Cohort (2017-2022) -- Study 4. HOMESIDE: Home-Based Caregiver Delivered Music Interventions for People Living with Dementia (2019-2022) -- Study 5. MATCH: Music Attuned Technology for Care via eHealth (2020-2025) -- Study 6. MAPS: Music and Psychology and Social Connections Program (2021-2022) -- Scope of the Text -- References -- 2 The Scope of Project Management -- How Out of Control Can a Controlled Trial Be? -- The Project Management Plan -- Five Phases of Clinical Trial Project Management -- Successful Management Approaches -- Good Communication Is Like the Oil in Your Engine -- Avoid Meeting Madness -- Documentation Avoids Miscommunication -- What's Happening Today: Calendar Management -- Accountability -- Problem Identification and Resolution -- Essential Clinical Trial Documents -- Study Protocol -- Manual of Operational Procedures -- Case Report Forms -- Clinical Site Management Plan -- Risk Management Plan -- Developing a Risk Assessment Plan -- Types of Risks in Trials -- Common Challenges in Clinical Trial Execution -- Balancing Complex Workloads -- Budget Constraints -- Poorly Planned Timelines -- Poor Task Prioritisation -- Conclusion -- References -- 3 The Art of Good Governance. ; What Is Governance? -- Governance at Project Design Stage -- Governance at Project Authorisation Stage -- Governance at Project Implementation Stage and Project Closure -- Project Governance Committees -- Trial Management Group -- Trial Steering Committee -- Data Safety Monitoring Board -- Project Operational Committees -- Whole Team Meetings -- Smaller Working Groups and Workstreams -- Capacity Building Committee -- Statistical Analysis Plan Team -- Public and Patient Involvement Committee -- Frameworks of PPI -- Components of PPI Participation -- Reasons the Public Get Involved -- Establishing and Implementing a PPI -- Conclusion -- References -- 4 Assembling and Uniting a Team -- Staffing to Your Needs -- Principal Investigator -- Project Manager -- Clinical Trial Manager -- Biostatistician -- Health Economist -- Information Scientist -- Data Manager -- Other Team Members -- Optimising Performance: A We-ness Culture -- Empowering the Team -- Safety Within the Group -- Leading the Team -- Conclusion -- References -- 5 Budgeting for Success: Management and Resource Planning -- Barriers and Enablers to Effective Resource Management -- Preparing a Study Budget -- Project Design and Set-Up -- Project Implementation -- Models to Budget for Recruitment -- Licensing Fees -- Using Routinely Collected Data -- Trial Site Visits and Monitoring -- Governance Costs -- Data Management and Analysis -- Project Management -- Public and Patient Involvement and Public Engagement -- Knowledge Translation and Exchange, Public Engagement, and Advocacy -- Conclusion -- References -- 6 Recruitment, Retention, and Follow-Up: Frustration or Bliss -- Introduction -- Why Do People Choose to Participate in Research? -- Why Do People Decline Participation in Research? -- Health Status and Stigma -- Scepticism, Fear and Mistrust -- Family Factors -- Language Barriers. ; Participant Burden -- Developing and Monitoring the Recruitment Strategy -- Participants -- Developing the Research Promotional Product -- Promoting the Study -- Price -- Working with Industry Partners -- Involvement of Public and Patients in Recruitment -- Strategies to Improve Conversion Rates -- Harness Trust -- Supporting Decision Making -- Minimise Burden of Participation -- Offering Appropriate Incentives -- Working with Your Recruitment Team -- Barriers to Participant Retention and Follow-Up -- Factors to Increase Retention -- Motivating the Recruitment Team -- Conclusion -- References -- 7 Quality Data Is Power: Data Management and Monitoring -- The Need for Good Data Management and Monitoring -- Defining Quality Data -- Levels of Data Monitoring -- The Data Management Plan (DMP) -- Systems for Data Collection and Management -- Type of Data and Measures -- Data Collection Methods -- Data Entry -- Data Security -- Data Cleaning and Quality Control -- Case Report Forms -- Data Access: Roles and Responsibilities -- Data Storage -- Study Participant Monitoring -- Data Sharing and Long-Term Preservation -- Monitoring and Reporting -- Developing an Electronic Data Capture System for Your Trial -- Overview of the EDC System Development Process -- Database User Interface -- Conclusion -- References -- 8 Development, Measurement, and Validation of Intervention Fidelity -- What Is Fidelity and Why Is It Important? -- Reporting of Intervention Fidelity in Creative Arts Therapies Literature -- Conceptual Frameworks of Fidelity -- Intervention Adherence -- Assessment of Intervention Components -- Strategies to Safeguard the Quality of Intervention Delivery -- Creative Arts Therapist Competence and Training -- Intervention Supervision and Monitoring -- Methods of Monitoring Adherence and Exposure -- Treatment Receipt -- Treatment Differentiation. ; Treatment Enactment -- Conclusion -- References -- 9 Statistical Analysis Plan -- What Is a Statistical Analysis Plan? -- Why Does a Trial Need a Statistical Analysis Plan? -- Developing a Statistical Analysis Plan -- Statistical Analysis Plan for Observational Studies -- Missing Data -- Approaches to Treat Missing Data -- References -- 10 Development of a Knowledge Translation and Exchange Plan -- Our Ethical Responsibility to Disseminate -- What Is and Why Implement Knowledge Translation and Exchange? -- Dissemination Development Plan -- Research Findings and Products -- Identify End-Users -- Collaborating with Partners for Dissemination -- Communicating Your Message -- Evaluation of Your Dissemination Plan -- Strategies and Considerations for Implementing KTE -- Authorship and Publishing -- Publication Bias -- Conclusion -- References -- 11 Innovation, Intellectual Property, and Commercialisation -- Innovation -- Intellectual Property-Copyright, Patents, Trademarks, and Secrets -- Establishing IP Asset Segments -- Is Commercialisation a Dirty Word? -- Commercialising the Creative Arts Therapies -- Engaging with the Business Development Departments at Universities -- Assessing Commercial Potential of Your IP -- Product Development -- Step 1. Translation of IP into a Proof of Concept -- Step 2. Conceptual Design and Development of Low-Fidelity Prototype -- Step 3. Iterative Design and Evaluation of High-Fidelity Prototype -- Step 4. Production and Testing of Minimal Viable Product -- Business Development -- Competitors -- Paths to Commercialisation -- Collaborating with Industry -- Confidentiality Agreements -- Establishing a New Arm of Your Team -- A Word of Caution About Commercialisation -- Conclusion -- References -- Index.
• Titolo autorizzato: Leadership and management of clinical trials in creative arts therapy
• ISBN: 3-031-18085-2
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Lingua di pubblicazione: Inglese
• Record Nr.: 9910620197803321
• Lo trovi qui: Univ. Federico II