36 Chapter 2 Feature box The ICON group Achilles recommends that: Clinical trials should include the agreed core outcome set for Achilles tendinopathy (COS-AT) as a minimum, so that future meta-analyses will be able to better estimate treatment effects. This COS-AT should be used alongside clinical trial reporting guidelines (e.g. CONSORT and ICON PART-T) in reporting clinical trials. Further evaluation of the COS-AT measurement instrument clinimetric properties is warranted – e.g. for validity, reliability, responsiveness and feasibility – as recommended in the OMERACT and COSMIN guidelines. New outcome measurement instruments should be further developed covering the core domains of patient overall rating, participation, function, quality of life, psychology, and pain over a specified time frame. The COS-AT represents the minimal reporting requirement, but should not prevent the use of other outcome measurement instruments in trials or clinical practice. Strengths and Limitations A strength of the consensus process for selecting the COS-AT is that we engaged a diverse group of participants, with various professions and nationalities, each possessing expertise in providing healthcare or performing research within the field of tendinopathy. It's important to acknowledge that there was limited diversity of professional participants and patients from regions other than the UK, US, Australia, and Europe and only 1 patient and 11 professional participants were present at the final consensus meeting. However, our participant pool for both surveys comprised a representative sample, with more than 10 patients having Achilles tendinopathy. While there are no specific OMERACT criteria for the attendance rate of an in-person meeting, we feel this as a limitation of this process, due to the international nature of the design and the planned meeting during a specific conference. However, the majority of the endorsed COS-AT was already established in Step 4 of the process by 29 experts (12 patients). One additional outcome measurement instrument was added after discussion during the in-person meeting. This collective effort ensures that the resulting COS-AT contains outcome measurement instruments holding genuine significance for patients with Achilles tendinopathy. Additionally, the consensus process was carried out without external funding influence. This independence strengthens the integrity of our COS-AT development. The prospective registration of the protocol is also a strength of this consensus process. There were several limitations in the development of the COS-AT. One notable challenge was the limited or low-quality evidence for many of the identified outcome measurement instruments. This may introduce uncertainty into the reliability and validity of the selected COS components. For example, the VISA-A has been criticised in terms of its psychometric properties.20,21 This might not be clearly noticeable in the quality assessment table (online supplementary File 4) we used in the process. This table was based on OMERACT guidelines, and as a result, structural validity and cross-cultural adaptation were not assessed, while COSMIN guidelines include these as part of construct validity. Especially regarding
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