Testing the psychometric properties of the APPRAISE PROM

  • Research type

    Research Study

  • Full title

    Testing the psychometric properties of a new patient-reported outcome measure to assess the outcomes of prolapse, incontinence, and mesh complication surgery: The APPRAISE Study.

  • IRAS ID

    329856

  • Contact name

    Georgina Jones

  • Contact email

    g.l.jones@leedsbeckett.ac.uk

  • Sponsor organisation

    Leeds Beckett University

  • Duration of Study in the UK

    3 years, 0 months, 1 days

  • Research summary

    Aim: The APPRAISE study aims to develop a new patient-reported outcome measure (PROM) to better allow women to report adverse outcomes and quality-of-life impacts following surgery for pelvic organ prolapse (POP), stress urinary incontinence (SUI) and mesh complications. This work package will follow two systematic reviews; an interview study exploring experiences of surgery for POP, SUI or mesh complications; and a study assessing the user acceptability of the prototype versions (paper and electric) of the new PROM. Following the first version of the PROM being developed, the purpose of this study is to evaluate its psychometric properties.

    Background: Different surgical treatments are available to treat POP and SUI, one of which uses polypropylene mesh (a synthetic material used to reinforce natural tissues in the pelvic floor). Some women who had mesh surgery experienced complications which required further corrective surgery. This had negative effects on their quality of life, and their experiences of using urogynaecology services. However, there is currently no surgery-specific patient-reported outcome measure (PROM) available for these women to tell us about the effects of pelvic floor surgery on their quality of life. Our research is addressing this, by developing a PROM to compare outcomes for the different surgical treatments for POP, SUI and mesh complications that captures the full range of effects on quality of life.

    Methods: The PROM will be administered to different samples of patients across four surveys, to evaluate its psychometric properties and to test the PROM in the context of short-term outcomes, long-term outcomes, and a clinical trial.

    Outputs: Our study findings will be shared across social media and mainstream media outlets using lay summaries, infographics and a YouTube video, at healthcare and academic conferences, in leading academic journals and with relevant third sector parties (e.g. British Society of Urogynaecology, Bladder and Bowel UK).

  • REC name

    East Midlands - Leicester South Research Ethics Committee

  • REC reference

    24/EM/0007

  • Date of REC Opinion

    4 Apr 2024

  • REC opinion

    Further Information Favourable Opinion