COrSIcA: Delphi survey and Consensus meeting

  • Research type

    Research Study

  • Full title

    Core Outcome measures in Squamous Intra-epithelial precursor lesions of the Anus (COrSIcA): Delphi survey and Consensus meeting

  • IRAS ID

    339389

  • Contact name

    David Finch

  • Contact email

    david.finch-2@manchester.ac.uk

  • Sponsor organisation

    University of Manchester

  • Duration of Study in the UK

    1 years, 0 months, 0 days

  • Research summary

    Anal cancer can be prevented through detection and treatment of a recognised precancerous lesion, known as anal intra-epithelial neoplasia (AIN), specifically the anal high-grade squamous intra-epithelial lesion (aHSIL) subtype.

    There are multiple treatments for aHSIL. These treatments have a variety of consequences for patients.

    The evidence for aHSIL treatments is of poor quality, such that the optimal approach cannot be defined. Existing trials in aHSIL have used different ways of measuring the effects of treatment. This makes comparing the results of trials very difficult. Trials have also been poor at reporting how treatment affects patients, e.g., life impact.

    We are developing a ‘core outcome set’ (COS) for trials in aHSIL. This is a list of outcomes (treatment effects) that future trials in aHSIL should measure and report on. COS include outcomes that are important to all involved with a particular condition (patients, clinicians, trialists). Utilisation of the COS in future trials will ensure that the outcomes reported are meaningful to those affected, and comparable to determine the optimal approach.

    A systematic review of existing literature and series of patient interviews has been undertaken to determine a 'long list' of potentially important outcomes. To elicit views about which outcomes are most important and finalise the COS, we will conduct a Delphi Survey followed by a consensus meeting involving key stakeholders (patients, clinicians, trialists with experience of being treated for/treating aHSIL).

    We aim to survey at least 100 participants in total. The survey can be taken online or in hard copy format and will take approximately 60-90 minutes to complete. We anticipate participation in 2-3 rounds of the survey.

    The results of the Delphi will be discussed at an online consensus meeting via Zoom involving an invited sample of Delphi participants. This meeting will last approximately 2-3 hours.

    The study will last approximately 1 year to completion of analysis.

  • REC name

    London - South East Research Ethics Committee

  • REC reference

    24/PR/0715

  • Date of REC Opinion

    16 Jul 2024

  • REC opinion

    Further Information Favourable Opinion