Study Title: ThyVoice a national observational cohort study of voice outcome after thyroid surgery



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Date and version No: Feb2016_ V2

Study Title:

ThyVoice - a national observational cohort study of voice outcome after thyroid surgery

Short title: ThyVoice

Ethics Ref: 16/EM/0070 IRAS project ID 197725 Date and Version No: Feb 2016 – V2

Chief Investigator:

Radu Mihai, Consultant Surgeon,

Oxford University Hospitals NHS Trust, Headington, Oxford OX3 7LU




Investigators:

MK Javaid. The Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences,

Nuffield Orthopaedic Centre, Windmill Road, Oxford OX3 7LD


Professor Martin Birchall

Royal National Throat, Nose and Ear Hospital , London

Tel: 0203 456 5197 Fax: 020 7833 9480 Email: m.birchall@ucl.ac.uk
Owain Rhys Hughes, ENT Specialist Registrar, Director of OperaVOX Ltd.


Sponsor:

Oxford University Hospitals NHS Foundation Trust

Funder:

British Association of Endocrine and Thyroid Surgeons (BAETS)

Chief Investigator Signature:




Declarations

R Mihai I have nothing to declare.

MK Javaid. In last five years received honoraria, travel and/or subsistence expenses from Amgen, Eli Lilly, Medtronic, Novartis, Procter and Gamble, Servier, Shire. I sit on scientific committees for the National Osteoporosis Society and International Osteoporosis Foundation. I am chair of the Metabolic Bone Disease Clinical Studies Group, Arthritis Research UK.

Owain Rhys Hughes. OperaVOX Ltd. together with Dr Ladan Baghai-Ravary was awarded a TORCH Knowledge Exchange Award from Oxford University in 2014.

Confidentiality Statement This document contains confidential information that must not be disclosed to anyone other than the Sponsor, the Investigator Team, host organisation, and members of the Research Ethics Committee, unless authorised to do so.

TABLE OF CONTENTS

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1.SYNOPSIS 5

2.ABBREVIATIONS 5

3.BACKGROUND AND RATIONALE 5

4.OBJECTIVES AND OUTCOME MEASURES 11

5.STUDY DESIGN 11

6.PARTICIPANT IDENTIFICATION 12

1Study Participants 12

2Inclusion Criteria 12

3Exclusion Criteria 12

7.STUDY PROCEDURES 12

4Recruitment 12

1Screening and Eligibility Assessment 13

5Informed Consent 14

6Baseline Assessments 15

7Subsequent Visits 16

8Discontinuation/Withdrawal of Participants from Study 16

9Definition of End of Study 16

8.SAFETY REPORTING 16

9.STATISTICS AND ANALYSIS 17

10Description of Statistical Methods 17

11The Number of Participants 17

12Analysis of Outcome Measures 17

10.DATA MANAGEMENT 19

13Access to Data 19

14Data Recording and Record Keeping 19

11.QUALITY ASSURANCE PROCEDURES 20

12.ETHICAL AND REGULATORY CONSIDERATIONS 20

15Declaration of Helsinki 20

16Guidelines for Good Clinical Practice 20

17Approvals 20

18Reporting 20

19Participant Confidentiality 20

20Expenses and Benefits 20

13.FINANCE AND INSURANCE 21

21Funding 21

22Insurance 21

14.PUBLICATION POLICY 21

15.REFERENCES 22

16.APPENDIX A: STUDY FLOW CHART 24

17.APPENDIX B: SCHEDULE OF STUDY PROCEDURES 25

18.APPENDIX C: AMENDMENT HISTORY 25



  1. SYNOPSIS


    Study Title

    THY-Voice – a national observational cohort study of voice outcome after thyroid surgery

    Short title

    THY-Voice

    Study Design

    Prospective cohort study

    Study Participants

    Patients undergoing thyroid surgery in UK centres

    Planned Sample Size

    1000

    Planned Study Period

    2 years (1 year recruitment + 1 year follow-up)




    Objectives

    Outcome Measures

    Primary


    To determine the real incidence of voice changes in the first year after thyroid surgery.

    Changes in the symptoms scores assessed using standardised questionnaires (VHI and VrQoL).

    Changes in acoustic voice parameters assessed using an iphone app.



    Secondary


    To explore whether swallowing difficulties are more common in patients who experience voice changes after thyroid surgery.

    Symptoms scores using a standardised questionnaire.
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