Additional file 9 of Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE study
Creators: name: Solovyeva, Olga
name: Dimairo, Munyaradzi
name: Weir, Christopher J.
name: Hee, Siew Wan
name: Espinasse, Aude
name: Ursino, Moreno
name: Patel, Dhrusti
name: Kightley, Andrew
name: Hughes, Sarah
name: Jaki, Thomas
name: Mander, Adrian
name: Evans, Thomas R. Jeffry
name: Lee, Shing
name: Hopewell, Sally
name: Rantell, Khadija Rerhou
name: Chan, An-Wen
name: Bedding, Alun
name: Stephens, Richard
name: Richards, Dawn
name: Roberts, Lesley
name: Kirkpatrick, John
name: de Bono, Johann
name: Yap, Christina
Publisher: name: figshare
Year: 2023
Subjects: subject: Medicine
subject: Sociology
subject: FOS: Sociology
classificationCode: 69999
subject: Biological Sciences not elsewhere classified
classificationCode: 80699
subject: Information Systems not elsewhere classified
subject: Developmental Biology
subject: Science Policy
classificationCode: 110309
subject: Infectious Diseases
subject: FOS: Health sciences
subject: Computational Biology

description: Additional file 9. Perception of proposed items and sensitivity analysis: Tables A9-1 – A9-3, Figures A9-1 – A9-13. Table A9-1. Summary of categorical and numerical ratings at Round One and 2. Figure A9-1. Percentage of participants changing their numerical scores at Round Two. Figure A9-2. Percentage of participants changing their categorical scores at Round Two. Table A9-2. Number of participants changing their ratings between Round One and Round Two. Table A9-3. Frequency and percentage of perfect agreement. Figure A9-3. Stacked bar plots of candidate item [17 SPIRIT-DEFINE] “Planned dosing regimens presented as a diagram or table, where applicable” by stakeholders. Figure A9-4. Stacked bar plots of candidate item [18 CONSORT-DEFINE] “Planned and delivered dosing regimens presented as a diagram or table, where applicable” by stakeholders. Figure A9-5. Stacked bar plots of candidate item [48 SPIRIT-DEFINE] “Statistical methods for additional analyses” by stakeholders. Figure A9-6. Stacked bar plots of candidate item [69 CONSORT-DEFINE] “Specify if and when results were reported whilst the trial was still ongoing” by stakeholders. Figure A9-7. Stacked bar plots of candidate item [70 SPIRIT-DEFINE] “Where the full trial protocol or the redacted version, with amendments, can be accessed” by stakeholders. Figure A9-8. Stacked bar plots of candidate item [17 SPIRIT-DEFINE] “Planned dosing regimens presented as a diagram or table, where applicable” by Continent. Figure A9-9. Stacked bar plots of candidate item [18 CONSORT-DEFINE] “Planned and delivered dosing regimens presented as a diagram or table, where applicable” by Continent. Figure A9-10. Stacked bar plots of candidate item [48 SPIRIT-DEFINE] “Statistical methods for additional analyses” by Continent. Figure A9-11. Stacked bar plots of candidate item [69 CONSORT-DEFINE] “Specify if and when results were reported whilst the trial was still ongoing” by Continent. Figure A9-12. Stacked bar plots of candidate item [70 SPIRIT-DEFINE] “Where the full trial protocol or the redacted version, with amendments, can be accessed” by Continent. Figure A9-13. Stacked bar plots of candidate item [5 SPIRIT-DEFINE] “Summary of findings from existing correlative biomarker, correlative and associated studies to support planned biomarker sub-study” by Continent.