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. 2019 May 1;9(4):e024002. doi: 10.1136/bmjopen-2018-024002

Table 1.

Core Outcome Set Standards for Development recommendations

Domain Standard
number
Methodology Notes
Scope
specification
1 The research or practice setting in which the COS is to be applied. Research studies that will inform clinical decision making.
2 The health condition(s) covered by the COS. All severities of cauda equina syndrome (CES).
3 The population(s) covered by the COS. Human adults aged 18 or above.
4 The intervention(s) covered by the COS. Clinical management of CES including surgery.
Stakeholders involved 5 Those who will use the COS in research. Clinical trialists in CES are healthcare professionals who manage patients with CES. They are included in standard 6.
6 Healthcare professionals with experience of patients with the condition. This will include clinicians, experts and healthcare professionals involved in CES management.
7 Patients with the condition or their representatives. Patients with a diagnosis of CES will be included.45
Consensus
Process
8 The initial list of outcomes considered both healthcare professionals and patients views. Systematic literature review22 considered healthcare professional views. Qualitative interviews considered patient views.
9 A scoring process and consensus definition were described a priori. Described in the ‘Scoring’ and ‘Analysis’ section of this protocol.
10 Criteria for including/dropping/adding outcomes were described a priori. Described in the ‘Analysis’ section of this protocol.
11 Care was taken to avoid ambiguity of language used in the list of outcomes. Plain language and clinical explanations available. These will be pilot tested with patients and healthcare professionals.

CES, cauda equina syndrome; COS, core outcome set.