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El. knyga: Leadership and Management of Clinical Trials in Creative Arts Therapy

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  • Formatas: EPUB+DRM
  • Išleidimo metai: 22-Oct-2022
  • Leidėjas: Palgrave Macmillan
  • Kalba: eng
  • ISBN-13: 9783031180859
Kitos knygos pagal šią temą:
Leadership and Management of Clinical Trials in Creative Arts TherapyDidesnis paveikslėlis
  • Formatas: EPUB+DRM
  • Išleidimo metai: 22-Oct-2022
  • Leidėjas: Palgrave Macmillan
  • Kalba: eng
  • ISBN-13: 9783031180859
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This book focuses on leadership and management strategies including project management, budget planning and management, governance, building a team, and developing a strategy for successful recruitment. Many creative arts therapy researchers lack training and experience in designing and implementing large scale high impact clinical trials. This book is the first in the creative arts therapies that provides guidance on clinical trial implementation. Data management, monitoring, and intervention fidelity and development of a statistical analysis plan are outlined. Finally, the text explores development of a dissemination plan as well as how to commercialise research.

1 Introduction
1(16)
Implementing Robust Creative Arts Therapies Trials
1(4)
Sharing Wisdom and Capacity Building
5(1)
So You Won The Grant, Now What?
6(1)
Past and Current Projects
7(5)
Study 1 Music Therapy to Aid Non-invasive Ventilation Transition for People with Motor Neuron Disease (2014-2015)
8(1)
Study 2 Singing My Story: Negotiating Identities Through Therapeutic Songwriting for People with Neurological Injuries (2015-2017)
8(1)
Study 3 MIDDEL: Music Interventions for Dementia and Depression in Elderly Care--The Australian Cohort (2017-2022)
9(1)
Study 4 HOMESIDE: Home-Based Caregiver Delivered Music Interventions for People Living with Dementia (2019-2022)
10(1)
Study 5 MATCH: Music Attuned Technology for Care via eHealth (2020-2025)
11(1)
Study 6 MAPS: Music and Psychology and Social Connections Program (2021-2022)
12(1)
Scope of the Text
12(3)
References
15(2)
2 The Scope of Project Management
17(30)
How Out of Control Can a Controlled Trial Be?
17(1)
The Project Management Plan
18(2)
Five Phases of Clinical Trial Project Management
20(2)
Successful Management Approaches
22(7)
Good Communication Is Like the Oil in Tour Engine
22(1)
Avoid Meeting Madness
23(2)
Documentation Avoids Miscommunication
25(2)
What's Happening Today: Calendar Management
27(1)
Accountability
28(1)
Problem Identification and Resolution
28(1)
Essential Clinical Trial Documents
29(5)
Study Protocol
30(2)
Manual of Operational Procedures
32(1)
Case Report Forms
33(1)
Clinical Site Management Plan
33(1)
Risk Management Plan
34(7)
Developing a Risk Assessment Plan
36(1)
Types of Risks in Trials
37(4)
Common Challenges in Clinical Trial Execution
41(3)
Balancing Complex Workloads
41(1)
Budget Constraints
42(1)
Poorly Planned Timelines
43(1)
Poor Task Prioritisation
43(1)
Conclusion
44(1)
References
44(3)
3 The Art of Good Governance
47(36)
What Is Governance?
47(2)
Governance at Project Design Stage
49(1)
Governance at Project Authorisation Stage
50(3)
Governance at Project Implementation Stage and Project Closure
53(1)
Project Governance Committees
54(10)
Trial Management Group
54(2)
Trial Steering Committee
56(4)
Data Safety Monitoring Board
60(4)
Project Operational Committees
64(6)
Whole Team Meetings
64(1)
Smaller Working Groups and Workstreams
65(3)
Capacity Building Committee
68(1)
Statistical Analysis Plan Team
69(1)
Public and Patient Involvement Committee
70(8)
Frameworks of PPI
71(2)
Components of PPI Participation
73(2)
Reasons the Public Get Involved
75(1)
Establishing and Implementing a PPI
75(3)
Conclusion
78(1)
References
79(4)
4 Assembling and Uniting a Team
83(24)
Staffing to Tour Needs
83(5)
Principal Investigator
88(2)
Project Manager
90(1)
Clinical Trial Manager
91(1)
Biostatistician
92(1)
Health Economist
93(1)
Information Scientist
94(1)
Data Manager
95(1)
Other Team Members
95(1)
Optimising Performance: A We-ness Culture
96(7)
Empowering the Team
97(1)
Safety Within the Group
98(4)
Leading the Team
102(1)
Conclusion
103(1)
References
103(4)
5 Budgeting for Success: Management and Resource Planning
107(14)
Barriers and Enablers to Effective Resource Management
107(5)
Preparing a Study Budget
112(1)
Project Design and Set-Up
112(2)
Project Implementation
114(5)
Models to Budget for Recruitment
114(1)
Licensing Fees
115(1)
Using Routinely Collected Data
115(1)
Trial Site Visits and Monitoring
116(1)
Governance Costs
116(1)
Data Management and Analysis
116(2)
Project Management
118(1)
Public and Patient Involvement and Public Engagement
118(1)
Knowledge Translation and Exchange, Public Engagement, and Advocacy
118(1)
Conclusion
119(1)
References
119(2)
6 Recruitment, Retention, and Follow-Up: Frustration or Bliss
121(30)
Introduction
121(3)
Why Do People Choose to Participate in Research?
124(1)
Why Do People Decline Participation in Research?
125(6)
Health Status and Stigma
125(1)
Scepticism, Fear and Mistrust
126(2)
Family Factors
128(1)
Language Barriers
128(1)
Participant Burden
129(2)
Developing and Monitoring the Recruitment Strategy
131(9)
Participants
132(1)
Developing the Research Promotional Product
132(2)
Promoting the Study
134(3)
Price
137(1)
Working with Industry Partners
138(1)
Involvement of Public and Patients in Recruitment
139(1)
Strategies to Improve Conversion Rates
140(4)
Harness Trust
140(1)
Supporting Decision Making
140(1)
Minimise Burden of Participation
141(1)
Offering Appropriate Incentives
142(1)
Working with Tour Recruitment Team
142(2)
Barriers to Participant Retention and Follow-Up
144(1)
Factors to Increase Retention
145(1)
Motivating the Recruitment Team
146(1)
Conclusion
146(1)
References
146(5)
7 Quality Data Is Power: Data Management and Monitoring
151(32)
The Need for Good Data Management and Monitoring
151(1)
Defining Quality Data
152(1)
Levels of Data Monitoring
153(3)
The Data Management Plan (DMP)
156(2)
Systems for Data Collection and Management
158(1)
Type of Data and Measures
159(1)
Data Collection Methods
160(2)
Data Entry
162(1)
Data Security
163(1)
Data Cleaning and Quality Control
164(5)
Case Report Forms
169(1)
Data Access: Roles and Responsibilities
169(1)
Data Storage
170(2)
Study Participant Monitoring
172(1)
Data Sharing and Long-Term Preservation
173(1)
Monitoring and Reporting
174(1)
Developing an Electronic Data Capture System for Tour Trial
175(3)
Overview of the EDC System Development Process
175(1)
Database User Interface
176(2)
Conclusion
178(1)
References
179(4)
8 Development, Measurement, and Validation of Intervention Fidelity
183(26)
What Is Fidelity and Why Is It Important?
183(3)
Reporting of Intervention Fidelity in Creative Arts Therapies Literature
186(1)
Conceptual Frameworks of Fidelity
187(1)
Intervention Adherence
187(6)
Assessment of Intervention Components
188(5)
Strategies to Safeguard the Quality of Intervention Delivery
193(4)
Creative Arts Therapist Competence and Training
194(2)
Intervention Supervision and Monitoring
196(1)
Methods of Monitoring Adherence and Exposure
197(4)
Treatment Receipt
201(2)
Treatment Differentiation
203(1)
Treatment Enactment
203(1)
Conclusion
204(1)
References
204(5)
9 Statistical Analysis Plan
209(14)
What Is a Statistical Analysis Plan?
209(1)
Why Does a Trial Need a Statistical Analysis Plan?
209(2)
Developing a Statistical Analysis Plan
211(4)
Statistical Analysis Plan for Observational Studies
215(1)
Missing Data
215(4)
Approaches to Treat Missing Data
216(3)
References
219(4)
10 Development of a Knowledge Translation and Exchange Plan
223(24)
Our Ethical Responsibility to Disseminate
223(1)
What Is and Why Implement Knowledge Translation and Exchange?
224(1)
Dissemination Development Plan
225(4)
Research Findings and Products
225(3)
Identify End-Users
228(1)
Collaborating with Partners for Dissemination
229(1)
Communicating Tour Message
230(1)
Evaluation of Tour Dissemination Plan
231(1)
Strategies and Considerations for Implementing KTE
232(3)
Authorship and Publishing
235(7)
Publication Bias
242(1)
Conclusion
243(1)
References
243(4)
11 Innovation, Intellectual Property, and Commercialisation
247(32)
Innovation
247(3)
Intellectual Property--Copyright, Patents, Trademarks, and Secrets
250(1)
Establishing IP Asset Segments
251(3)
Is Commercialisation a Dirty Word?
254(1)
Commercialising the Creative Arts Therapies
255(2)
Engaging with the Business Development Departments at Universities
257(1)
Assessing Commercial Potential of Tour IP
258(1)
Product Development
258(10)
Step 1 Translation of IP into a Proof of Concept
262(3)
Step 2 Conceptual Design and Development of Low-Fidelity Prototype
265(1)
Step 3 Iterative Design and Evaluation of High-Fidelity Prototype
265(2)
Step 4 Production and Testing of Minimal Viable Product
267(1)
Business Development
268(2)
Competitors
268(1)
Paths to Commercialisation
269(1)
Collaborating with Industry
270(3)
Confidentiality Agreements
272(1)
Establishing a New Arm of Tour Team
273(1)
A Word of Caution About Commercialisation
274(1)
Conclusion
274(1)
References
275(4)
Index 279
Professor Felicity Anne Baker is Associate Dean (Research) at the Faculty of Fine Arts and Music, as well as Director of International Research Partnerships for the Creative Arts and Music Therapy Research Unit, University of Melbourne. She also holds a position as Professor II at the Norwegian Academy of Music and is currently Associate Editor, Journal of Music Therapy. Felicity has thirty years of experience as a music therapy clinician and twenty years as a researcher. Over her career, she has accumulated more than AUS$15Million in funding to support implementation of several interdisciplinary clinical trials including three National Health and Medical Research Council Grants and a Medical Research Future Fund grant. She is a former Australia Research Council Future Fellow and has won numerous international awards for her research. She is widely published, and her work is highly cited. Felicity is well known for her research in neurorehabilitation, dementia care, and in developing the music therapy method of songwriting. Aside from this latest book, she has published 5 books and more than 170 book chapters and journal articles including publications in The Lancet Healthy Longevity, Contemporary Clinical Trials Communication, and Clinical Rehabilitation.
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