Core Outcome Measures in Effectiveness Trials

Setting an Agenda for Assessment of Health-related Quality of Life Among Men with Prostate Cancer on Active Surveillance: A Consensus Paper from a European School of Oncology Task Force.

General Information

Abstract:
BACKGROUND:

Literature on the health-related quality of life (HRQoL) for men with localized prostate cancer (PCa) on active surveillance (AS) shows a need for methodological guidance regarding HRQoL issues and how to address them.
OBJECTIVE:

The European School of Oncology Task Force (ESO TF) aimed to identify a core set of research questions and related measures to include in AS HRQoL studies.
DESIGN, SETTING, AND PARTICIPANTS:

A modified Delphi study was used to reach consensus on AS HRQoL research topics and tools between 2014 and 2015. Data were collected by engaging a multidisciplinary team of 15 experts.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS:

An open-ended questionnaire was used to collect information from ESO TF members regarding issues in AS HRQoL research. Then a structured questionnaire was used to collect ratings on the usefulness/importance of different AS HRQoL aspects. Items that =80% of ESO TF members rated as useful/important were retained. Items with a 50-80% rating were discussed to reach final agreement.
RESULTS AND LIMITATIONS:

Six main research questions concerning the selection of outcome measures, measurement tools, and comparison groups were identified as relevant. The core set of measures identified were related to individual characteristics, psychological dimensions; decision-making-related issues, and physical functioning. The multidisciplinary expertise of ESO TF members was a significant asset, even if bringing different backgrounds to the discussion table represented a challenge.
CONCLUSIONS:

HRQoL measures have to be sensitive to the specific needs of men on AS. The definition of HRQoL outcomes will enhance a broader understanding of the HRQoL of men on AS and sustain patient-centered medicine.
PATIENT SUMMARY:

An international panel agreed on a set of health-related quality-of-life aspects to be assessed among men on active surveillance for prostate cancer. Valid relevant questionnaires were identified. The experts' indications lay a foundation for future research and clinical practice.

Aim:
The European School of Oncology Task Force (ESO TF) aimed to identify a core set of research questions and related measures to include in AS HRQoL studies.

Authors:
Silvia Villaa, Friederike Kendelb, Lionne Venderbosc, Tiziana Rancatia, Chris Bangmac, Peter Carrolld, Louis Denise, Laurence Klotzf, Ida J. Korfagec, Athene J. Laneg, Tiziana Magnania, Ken Mastrise, Antti Rannikkoh, Monique Roobolc, Bruce Trocki, Roderick Van den Berghj, Hendrik Van Poppelk, Riccardo Valdagnia and Lara Bellarditaa

Publication

Journal:
European Urology
Volume:
17
Issue:
2
Pages:
274 - 280
Year:
2017
DOI:
Further Study Information

Date:
Funding source(s):

Health Area

Disease Category

Disease Name

Target Population

Age Range
-

Sex
Unknown


Nature / type of Intervention
Unknown

Method(s)

Unknown

Stakeholders Involved

Unknown

Study Type

Unknown

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