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.