The TAPER Study

How and why do women decide about, and experience stopping HRT, why do women decide to restart and is a clinical trial comparing stopping methods feasible?

There is currently limited evidence to help women and their doctors, decide when and how to stop taking HRT. Stopping HRT often leads to menopausal symptoms returning. This can be problematic, and some women then choose to restart HRT. This can negatively affect women and also increase healthcare visits and healthcare costs.

The TAPER Study will look at what matters most to women and their doctors/nurses when women are considering stopping or restarting HRT. We will interview women and healthcare professionals to hear their views. The information we gather from women and healthcare professionals will be used to design a special type of survey to find out why women decide to restart HRT and how they weigh up the pros and cons of doing this. These results from this survey will describe what women consider important when stopping/restarting HRT. Finally, we will use all the information we have gathered to think about whether it is a feasible to conduct a clinical trial to investigate the best way to discontinue HRT.

How can you get involved?

Have you stopped or tried to stop Hormone replacement therapy HRT in the last 3 years?
Are you a woman aged over 45?

If so, researchers from the University of Birmingham would like to hear from you.

We are exploring why and how women stop HRT and would love to learn from your experience.

We welcome participants from all backgrounds, as we know menopause journeys vary for everyone.

If you would like to find out more, please email taper@contacts.bham.ac.uk.

Project Lead

Dr Sarah Hillman
Clinical Associate Professor in Women’s Health and Primary Care
Staff profile for Sarah Hillman, Clinical Associate Professor in Women's Health & Primary Care, 125 Anniversary Fellow, School of Health Sciences, University of Birmingham

More about the project

Research question

Discontinuing HRT; How and why do women decide and experience stopping HRT, why do women decide to restart and is a clinical trial comparing stopping methods feasible?

Background

Hormone replacement therapy (HRT) is an effective treatment for symptoms of the menopause. Most menopause care (including prescribing of HRT) happens in primary care. At some point most women stop HRT, often concerned about longer term health risks associated with duration of use. However, around 40% of women have resurgent symptoms when stopping HRT and 1-in-4 who stop will restart HRT, potentially leading to a cycle of stopping/starting. It is not known how best to stop HRT and whether tapering or stopping abruptly affects health outcomes and care costs.

Objectives

Explore the experiences of women who have stopped/are stopping HRT and Health Care Professionals (HCPs) that care for them using semi-structured interviews.
Conduct a systematic review and meta-analysis of qualitative studies on stopping/restarting HRT.
Establish what women value when considering restarting HRT using a discrete choice experiment.
Design a non-randomised feasibility study looking at tapering of HRT
Undertake a feasibility study to determine if a future definitive trial of abrupt stopping vs tapering HRT is possible.

Methods

Work package 1 (month 1-14) Findings from a synthesis of existing data and experiences of a PPI panel and Project Research Group (PRG) will inform an interview schedule for semi-structured interviews with women who have stopped / are stopping HRT and HCPs caring for them.
Work Package 2 (month 6-17) we will perform a systematic review and meta-analysis of qualitative studies looking at stopping HRT +/- restarting including the results from Work Package 1. This will inform attributes (variables) of most importance for Work Package 3 (Discrete choice experiment DCE) and priority outcomes for Work Package 4.
Work Package 3(month 15-33) After establishing the attributes (variables) of most importance, supported by a health economist, we will undertake a DCE within a survey to compare the trade-offs in health states when women consider restarting HRT.
Work Package 4 (month 23-47) we will use the results of Work Packages 1/2/3 and work with key stakeholder groups (women, GPs, pharmacists, third sector organisations, trial methodologists) to design a feasibility study and collect data, including those relevant to supporting the need for a future definitive trial comparing methods of stopping HRT.
Work Package 5 (month 48-72) undertake a non-randomised feasibility study in general practices serving a diverse population comparing three different tapering regimes for stopping HRT (long, medium, short taper) in 60 women to inform the design of a definitive trial.

Research team

Dr El Molloy

Mentors:

External collaborators:

Professor Jeremy Dale - University of Warwick
Professor Martha Hickey - University of Melbourne
Professor Jane Daniels - University of Nottingham
Professor Richard McManus - Brighton and Sussex Medical School

The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.