Improving Miscarriage Prevention Research: a survey exploring the expectations of service users and stakeholders (IMPRESS) - a study protocol for a UK-based survey.

ABSTRACT:

Introduction

Interventional clinical trials in recurrent miscarriage use varying expected effect sizes to inform their sample size calculations. Often these are not informed by what stakeholders consider a meaningful treatment effect. Adaptive trial designs may integrate stakeholder views on trial success and futility but the criteria to inform this is lacking. This study aims to understand relevant stakeholder views of what is considered a worthwhile treatment effect for miscarriage prevention interventions and what is acceptable stopping criteria in miscarriage clinical trials.

Methods and analysis

The study is designed as a cross-sectional online anonymous survey. The survey presents different scenarios to respondents relating to varying target differences and probability

SUBMITTER: Black N 

PROVIDER: S-EPMC11284882 | biostudies-literature | 2024 Jul

REPOSITORIES: biostudies-literature