Responses

Download PDFPDF

Protocol for Compass: a randomised controlled trial of primary HPV testing versus cytology screening for cervical cancer in HPV-unvaccinated and vaccinated women aged 25–69 years living in Australia
Compose Response

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.
Author Information
First or given name, e.g. 'Peter'.
Your last, or family, name, e.g. 'MacMoody'.
Your email address, e.g. higgs-boson@gmail.com
Your role and/or occupation, e.g. 'Orthopedic Surgeon'.
Your organization or institution (if applicable), e.g. 'Royal Free Hospital'.
Statement of Competing Interests

PLEASE NOTE:

  • A rapid response is a moderated but not peer reviewed online response to a published article in a BMJ journal; it will not receive a DOI and will not be indexed unless it is also republished as a Letter, Correspondence or as other content. Find out more about rapid responses.
  • We intend to post all responses which are approved by the Editor, within 14 days (BMJ Journals) or 24 hours (The BMJ), however timeframes cannot be guaranteed. Responses must comply with our requirements and should contribute substantially to the topic, but it is at our absolute discretion whether we publish a response, and we reserve the right to edit or remove responses before and after publication and also republish some or all in other BMJ publications, including third party local editions in other countries and languages
  • Our requirements are stated in our rapid response terms and conditions and must be read. These include ensuring that: i) you do not include any illustrative content including tables and graphs, ii) you do not include any information that includes specifics about any patients,iii) you do not include any original data, unless it has already been published in a peer reviewed journal and you have included a reference, iv) your response is lawful, not defamatory, original and accurate, v) you declare any competing interests, vi) you understand that your name and other personal details set out in our rapid response terms and conditions will be published with any responses we publish and vii) you understand that once a response is published, we may continue to publish your response and/or edit or remove it in the future.
  • By submitting this rapid response you are agreeing to our terms and conditions for rapid responses and understand that your personal data will be processed in accordance with those terms and our privacy notice.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.

Vertical Tabs

Other responses

Jump to comment:

  • Published on:
    Sample Size Revision - Protocol for Compass: a randomised controlled trial of primary HPV testing versus cytology screening for cervical cancer in HPV-unvaccinated and vaccinated women aged 25–69 years living in Australia
    • Karen Canfell, Director, Cancer Research Division, Cancer Council NSW. Co-principal Investigator of the Compass Trial. As per original publication.
    • Other Contributors:
      • Marion Saville, Executive Director VCS Foundation Ltd. Co-principal Investigator of the Compass Trial.
      • Michael Caruana, Senior Research Fellow
      • Val Gebski, Head of Biostatistics and Research Methodology, NHMRC Clinical Trials Centre
      • Jessica Darlington-Brown, Research Operations Manager
      • Julia Brotherton, Medical Director, VCS Population Health
      • Stella Heley, Senior Liaison Physician
      • Philip. E Castle, Professor

    The primary purpose of this response letter is to update the protocol to revise the sample size of the Compass Trial.

    Summary

    Compass is a randomised controlled trial, operating alongside the Australian National Cervical Screening Program (NCSP). Under the auspices of the Independent Data Safety Monitoring Committee (IDSMC) and Scientific Advisory Committee (SAC) we have performed a re-analysis of our original estimate of the total trial sample size. This was prompted by two factors: (1) impact of the NCSP transition to primary HPV screening and (2) emergence of new evidence relevant to the sample size calculation. With consideration to the resource implications of the renewed program on trial recruitment and acknowledging that the original sample size of 121,000 women for the main trial was calculated in 2014 (prior to the emergence of new relevant evidence) the trial sample size was re-estimated.

    The sample size recalculation has resulted in a reduced recruitment target for the cohort of women in Compass Trial who were age-eligible for publicly funded HPV vaccination in Australia (the younger cohort) from 84,700 to 40,000 women; consequently the total recruitment target has been revised from 121,000 to 76,300. The updated sample size estimate has been approved by the Human Research Ethics Committee and is reflected in the trial registration (ClinicalTrials.gov Identifier: NCT02328872).

    (1) Impact of the NCSP transition to primary HPV scree...

    Show More
    Conflict of Interest:
    KC and MS are co-principal investigators of Compass. KC( co-principal investigator)and JDB and MC (project coordinator, project statistician) are on the Compass study team. Compass is conducted and funded by VCS Foundation, a government-funded health promotion charity. Neither KC, JDB, MC nor their institution on their behalf (Cancer Council NSW) receives any direct funding from industry for this trial or any other project. MS (coprincipal investigator), JB and SH report that their institution, VCS Foundation, received equipment and funding from Roche Molecular Systems and Roche Tissue Diagnostics, AZ, USA, during the conduct of the study. PEC reports non-financial support from Roche Molecular Systems, outside the submitted work. VG has no conflicts of interest to disclose.