Core Outcome Measures in Effectiveness Trials

Developing a core outcome set for clinical studies investigating pain relieve methods for intrauterine device insertion

General Information

Summary:
Intrauterine devices (IUDs) such as levonorgestrel intrauterine system (LNG-IUS) or copper-bearing devices are amongst some of the safest, and most effective long-acting reversible contraceptives (LARCs) available. Insertional pain is one of the major side effects described by patients and a reason why some practitioners recommend less effective contraceptive methods, particularly for young women who would benefit most.

Various pharmacological and non-pharmacological methods have been trialled to reduce IUD insertion pain/improve ease of insertion. Despite the large number of studies
available in the current published literature, there is no consensus over the most effective strategy to reduce pain associated with IUD Insertion. This lack of consensus may stem from variation in trial outcomes/outcome measures.

There are a variety of outcomes reported in studies investigating IUD insertion but the majority focus on patient reported pain levels during the stages of insertion. Whilst
outcomes chosen for analysis varied significantly between studies, their analysis have consistently been measured with the use of visual analogue score (VAS) in most studies on IUD insertion.

Without a set of standardized outcomes/outcome measures, meaningful comparisons would prove to be difficult even amongst studies with comparable interventions. The
heterogeneity of the data between clinical trials designed with different outcomes results in poor quality of systematic reviews, meta-analyses ultimately making the interpretation of treatment effect difficult.

Developing a core outcome set (COS); a minimum list of outcomes in consultation with major stakeholders including patients and healthcare professionals will ensure the
outcomes are 1) consistently measured and reported in clinical trials 2) clinically relevant 3) patient centred (3) . Developing a COS for clinical trials investigating pain relief methods for IUD insertion pain methods will ultimately lead to better clinical guidelines and improve the experience of IUD insertion for patients.

In recent years, initiatives such as Core Outcome Measures in Effectiveness Trials (COMET), and Core Outcomes in Women's Health (CROWN) have been at the forefront of promoting, creating and disseminating COS in various clinical areas pertaining to Women’s Health. Using the methodology described for COS development by COMET, we aim to replicate the success of previous COS development projects to identify COS for clinical trials on IUD insertion.

Contributors:
Dr Patricia Moore
Affiliations: Royal Women's Hospital (Abortion Contraception Service)
Position: Principal Investigator (Head of Unit)
Responsibilities: project design and protocol development, manuscript production

Dr Louie Ye
Affiliations: Royal Women's Hospital (Abortion Contraception Service)
Position: Coordinating principal investigator (Hospital Medical Officer)
Responsibilities: project design and protocol development, participant recruitment at RWH,
data analysis, and manuscript production

Dr Catherine Streeton
Affiliations: Royal Women's Hospital (Abortion Contraception Service)
Position: Investigator (Senior Clinician)
Responsibilities: project design and protocol development, manuscript production

Associate Professor Kirsten Black
Affiliations: Royal Prince Alfred Hospital/University of Sydney
Position: Investigator (Joint head of obstetrics, gynaecology and neonatology)
Responsibilities: project design and protocol development, participant recruitment at RPA
hospital, manuscript production

Further Study Information

Current Stage:
Planning
Date:
January 2020 - January 2021
Funding source(s):
To be confirmed

Health Area

Disease Category
Gynaecology

Disease Name
N/A

Target Population

Age Range
18 - 50

Sex
Female


Nature / type of Intervention
Device

Method(s)

Delphi process
Literature review
Survey

Using a step-wise process as described in previous COS development protocols, we aim to first identify potential core outcomes/measures through literature review and qualitative surveys. We will then evaluate the core outcomes/measures using the Delphi process and ultimately disseminate COS via publication of the findings.


Stakeholders Involved

Clinical experts
Consumers (patients)
Researchers
Service providers

Study Type

COS for clinical trials or clinical research
COS for practice

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