Core Outcome Measures in Effectiveness Trials

Development of a core outcome set for clinical trials in Achilles tendinopathy

General Information

Summary:
Achilles tendinopathy is the clinical diagnosis for load-related pain and disability localized to the Achilles tendon. This condition frequently leads to chronic symptoms with poorer quality of life and substantial healthcare consumption. There has been a large increase in research on Achilles tendinopathy over the past decades. In the published literature, there is substantial heterogeneity in the outcome measures used and the outcomes included are not always those that patients regard as most important. This influences patient care, because health care professionals and researchers are not able to adequately interpret, compare and synthesize (in meta-analyses) the results from intervention studies. There is also the possibility of outcome-reporting bias if selected outcomes rather than pre-established core outcomes are reported. Synthesizing data is the cornerstone of evidence-based practice, emphasizing the crucial need to define a core outcome set (COS) of validated outcome measures that evaluate established core health-related domains. This COS should be specific for Achilles tendinopathy and agreed upon by patients, researchers and health care providers. We recently conducted a Delphi study of expert tendinopathy clinicians and researchers as well as patients with tendinopathy (at various locations) to establish generic core outcome domains for tendinopathy. This resulted in a specific core domain set of 9 items, which serves as the basis for identifying a COS specifically for Achilles tendinopathy. The COS for clinical trials of interventions for Achilles tendinopathy will be developed by a multicontinental, multidisciplinary working group. The aim of the present project is to develop and disseminate a COS for clinical trials in Achilles tendinopathy.

Contributors:
Principal Investigators: Karin Grävare Silbernagel, Robert-Jan de Vos, Peter Malliaras and Bill Vicenzino.
Contributors: Håkan Alfredson, Inge van den Akker-Scheek, Jarrod Antflick, Mathijs van Ark, Kenneth Farnqvist, Zubair Haleem, Shawn Hanlon, Jean-Francois Kaux, Paul Kirwan, Bavesh Kumar, Trevor Lewissky, Adrian Mallows, Lorenzo Masci, Dylan Morrissey, Myles Murphy, Richard Newsham-West, Richard Norris, Seth O’Neil, Koen Peers, Igor Sancho, G. Shivapatham, Pat Vallance, and Arco van der Vlist

Further Study Information

Current Stage:
Ongoing
Date:
November 2018 - 2020
Funding source(s):
To be confirmed

Health Area

Disease Category
Rehabilitation

Disease Name
Achilles tendinopathy

Target Population

Age Range
16 - 100

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus meeting
Delphi process
Survey
Systematic review

Five stage process including: (I) a systematic review on available outcome measurement instruments, (II) an online survey on truth and feasibility of the available measurement instruments, (III) an assessment of the methodological quality of the selected outcome measurement instruments, (IV) an online survey on the measurement instruments as core outcome set, and (V) a consensus in person meeting.


Stakeholders Involved

Clinical experts
Consumers (patients)
Epidemiologists
Methodologists
Patient/ support group representatives
Researchers

Study Type

COS for clinical trials or clinical research
COS for practice
Recommended outcome measures (measurement)

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