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  • Published on:
    Amendment to the OPTIMUM Protocol
    • Parthipan Sivakumar, Clinical Research Fellow St Thomas' Hospital
    • Other Contributors:
      • Liju Ahmed, Consultant Respiratory Physician

    To the editor

    We would like to notify readers of two amendments that have been made to the OPTIMUM trial protocol since its publication in the BMJ Open in October 2016. These have been approved by the Regional Ethics Committee (Brighton and Sussex - 15/LO/1018)

    1) Indwelling Pleural Catheter Pathway: On the day follow-up 4 for the indwelling pleural catheter group, the criteria of <150ml/day fluid output to administer talc has been removed as complete drainage on day 1 may be limited due to symptoms.

    2) Set up of international sites: For international sites (defined as outside of the UK), the trial pathway will remain the same. To ensure satisfactory trial conduct and accurate data capture, the OPTIMUM database will be contained on a web-based browser-accessible database. This password protected, secure database service will only be accessible to the trial team at GSTT as well as the satellite international sites.

    User policies (with unique logins) will be implemented to prevent unauthorised data manipulation and access to data outside of the institutions recruited and a full GCP compliant audit trail will be used to monitor activity.

    Yours Sincerely

    Dr Parthipan Sivakumar & Dr Liju Ahmed

    Conflict of Interest:
    None declared.