Table 3 COS-STAD review for the included COS development studies
Study | Auvinen 1996 [21] | Chen 2014 [22] | Dawson 1998 [23] | Denis 1997 [24] | MacLennan 2017 [25] | Martin 2015 [26] | |
Study type | COS for clinical trials or clinical research | COS patient reported outcomes | COS for clinical trials or clinical research | COS for clinical trials or clinical research | COS for clinical trials or clinical research | COS for practice | |
Methods for consensus | Semi structured discussion; meeting | Systematic literature review; consensus meeting | Survey | Semi structured discussion: meeting | Consensus meeting; Delphi; focus groups; systematic review | Modified Delphi; teleconference; surveys | |
Domain | Minimum standard | ||||||
Scope specification | The research or practice setting(s) in which the COS is to be applied | Yes | Yes | Yes | Yes | Yes | Yes |
The health condition(s) covered by the COS | Yes | Yes | Yes | Yes | Yes | Yes | |
The population(s) covered by the COS | Yes | Yes | Yes | Yes | Yes | Yes | |
The intervention(s) covered by the COS | Yes | Yes | NR | NR | Yes | Yes | |
Stakeholders involved | Those who will use the COS in research | Yes | NR | Yes | NR | NR | No |
Healthcare professionals with experience of patients with the condition | NR | Yes | Yes | NR | Yes | Yes | |
Patients with the condition or their representatives | No | Yes | No | NR | Yes | Yes | |
Consensus process | Initial list of outcomes considered both healthcare professionals’ and patients’ views | NR | No | Yes | NR | Yes | Yes |
A scoring process and consensus definition were described a priori | NR | NR | NR | NR | Yes | NR | |
Criteria for including/dropping/adding outcomes were described a priori | NR | NR | NR | NR | Yes | NR | |
Care was taken to avoid ambiguity of language used in the list of outcomes | NR | No | NR | NR | Yes | NR | |
Study | Middleton 1995 [27] | Morgans 2015 [28] | Schellhammer 1997 [29] | Van den Bos 2014 [30] | Van den Bos 2015 [31] | ||
Study type | COS for clinical trials or clinical research | COS for practice | COS for clinical trials or clinical research | COS for clinical trials or clinical research | COS for clinical trials or clinical research | ||
Methods for consensus | Literature review | Modified Delphi; literature review; teleconferences | Literature review; conference | Modified Delphi; consensus meeting; literature review | Delphi process; consensus meeting; literature review | ||
Domain | Minimum standard | ||||||
Scope specification | The research or practice setting(s) in which the COS is to be applied | Yes | Yes | Yes | Yes | Yes | |
The health condition(s) covered by the COS | Yes | Yes | Yes | Yes | Yes | ||
The population(s) covered by the COS | Yes | Yes | Yes | Yes | Yes | ||
The intervention(s) covered by the COS | Yes | Yes | NR | Yes | Yes | ||
Stakeholders involved | Those who will use the COS in research | NR | No | NR | Yes | NR | |
Healthcare professionals with experience of patients with the condition | NR | Yes | NR | Yes | Yes | ||
Patients with the condition or their representatives | No | Yes | NR | No | No | ||
Consensus process | Initial list of outcomes considered both healthcare professionals’ and patients’ views | No | Yes | Yes | No | No | |
A scoring process and consensus definition were described a priori | NR | NR | NR | NR | NR | ||
Criteria for including/dropping/adding outcomes were described a priori | NR | NR | NR | NR | NR | ||
Care was taken to avoid ambiguity of language used in the list of outcomes | No | NR | NR | No | NR |