Improving outcome measures for clinical trials of heavy menstrual bleeding: a mixed methods study

Background

Core outcome sets (COS) guide the selection of outcomes to be assessed in clinical trials. But for some trials, there will be multiple approaches or tools developed that can be used to assess each outcome. For example, the COS developed by Cooper and colleagues (2023) identified menstrual blood loss as a core outcome for trials evaluating treatments for heavy menstrual bleeding. Numerous approaches, including validated measures such as the alkaline-haematin method, and pictorial blood loss assessment charts have been used to measure change in menstrual blood loss in response to treatment in clinical trials, but all have associated limitations. Furthermore, trials have used different measurement tools, impacting the ability to appropriately synthesise trial results, or compare  efficacy of treatments across trials. This limits the usefulness of trials, and meta-analyses of their results, and delays implementation of effective treatments for women affected.

What the studentship will encompass

This studentship will seek to improve the design of outcome measures for menstrual blood loss in clinical trials and further guide those applying the COS in these trials by:

1. Reviewing the application and uptake of the COS in completed and ongoing randomised trials of treatments for heavy menstrual bleeding, eligible for a series of NIHR-funded systematic reviews. Specifically, it will identify and critically appraise approaches to measuring menstrual blood loss.
2. Conducting qualitative studies with women affected by heavy periods to explore the acceptability of measures used in clinical trials and seek women’s preferences.
3. Informing the development of an improved outcome measure for menstrual blood loss that is feasible, measurable and acceptable for use in future clinical trials

It will also identify and evaluate statistical methods used to synthesise (meta-analyse) existing clinical trial data on menstrual blood loss to better guide the choice of method for future meta-analysis and better inform clinical practice. The studentship will also consider whether choice of methods might improve the synthesis of other outcomes with multiple tools or metrics.

Detail of supervision, including the roles of any named co-supervisors

The supervisory team will meet regularly (initially weekly) to ensure progress of both project and student. CV has expertise and experience in evidence synthesis and PPI. She has supervised PhD students to completion and oversees the departmental PhD programme. DF, ER and AS have supervised PhD and numerous MSc students, and will provide expertise in statistical methods for trials and meta-analysis (DF), evidence synthesis in womens health (ER) and mixed methods research, in particular qualitative methods in clinical research (AS). One additional supervisor (TBC) will bring knowledge of relevant core outcomes, outcome development and clinical perspectives menstrual health.  

Detail of any planned field work/ Secondments/industry placement

None planned but relevant opportunities will be sought and supported.

Detail of any PPI

There has been considerable PPI throughout the NIHR-funded series of reviews of treatments for heavy periods, with the influence of women’s voices in that research providing the impetus for this proposal. PPI will continue to be integral to appropriate design of qualitative studies and women’s voices will also be vital in informing considerations for developing an improved outcome measure for assessing menstrual blood loss.  

HOW TO APPLY

You are applying for a PhD studentship from the MRC TMRP DTP. A list of potential projects and the application form is available online at:

https://mrctmrpdtp.com/current-opportunities/

Please complete the form fully. Incomplete forms will not be considered. CVs will not be accepted for this scheme.

Please apply giving details for your first choice project. You can provide details of up to two other TMRP DTP projects you may be interested in at section B of the application form.

Before making an application, applicants should contact the project supervisor to find out more about the project and to discuss their interests in the research before 06 January 2025.

The deadline for applications is 12 noon (GMT) 13 January 2025. Late applications will not be considered.

Completed application forms must be returned to: [email protected]

Informal enquiries may be made to Dr Claire Vale – [email protected]