Table 4.
Final core outcome set (COS) domains/subdomains and their respective definitions.
| Domain | Definition | Included in final COS for |
|||
|---|---|---|---|---|---|
| Acute pain | Transition from acute to chronic pain | Recurrent pain | Chronic pain | ||
| Pain | An unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage. | Yes | Yes | Yes | Yes |
| Pain Intensity | Magnitude of the pain sensations experienced (in the past week). | Yes | Yes | N/A | Yes |
| Pain Interference | The degree to which there are consequences of pain on aspects of a participant's life (in the past 24 h or past week for acute or chronic pain, respectively). | Yes | Yes | Yes | Yes |
| Quality of Life | Broad multidimensional concept that usually includes subjective evaluations of both positive and negative aspects of life. | Yes | Yes | Yes | Yes |
| Physical Function | Ability to carry out activities requiring physical actions. | Yes | Yes | No | Consider |
| Sleep | Perceptions of difficulty falling asleep, sleep quality, sleep depth, duration and restoration associated with sleep. | No | Consider | No | No |
| Analgesic Use | Use of a drug that reduces pain. | Consider | N/A | N/A | Dropped |
| Psychological Functioning | The ability to achieve one's own goals within themselves and the external environment. It includes an individual's behavior, emotion, social skills, and overall mental health. | Dropped | Consider | Consider | Consider |
| Activities of daily living | Fundamental skills required to independently care for oneself, such as eating, bathing, and mobility. | Dropped | Dropped | Dropped | Yes |
| Quality of life (physical) | Subjective evaluations of both positive and negative aspects of physical life (i.e., pain and discomfort, energy and fatigue, sexual activity, sleep and rest, sensory functions). | N/A | N/A | N/A | Consider |
| Health Related Quality of Life | At an individual level, HRQOL includes physical and mental health perceptions (e.g., energy level, mood) and their correlates—including health risks and conditions, functional status, social support, and socioeconomic status. | N/A | N/A | Yes | No |
| Disability | Any condition of the body or mind (impairment) that makes it more difficult for the person with the condition to do certain activities (activity limitation) and interact with the world around them (participation restrictions). | N/A | N/A | Dropped | No |
| Pain Affect | The distress caused by the pain, reflecting the emotional response to pain. | N/A | N/A | N/A | No |
| Medication Use | Use of correct (and/or incorrect) medication. | Dropped | N/A | No | N/A |
| Pain Temporality | Variability in intensity, time to onset of meaningful pain relief, durability of pain relief, and frequency, duration and intensity of episodes of breakthrough pain. | N/A | Dropped | Yes | Dropped |
| Activity Limitations | A dimension of disability, such as difficulty seeing, hearing, walking, or problem solving. | Dropped | N/A | Yes | Dropped |
Yes = Included in final COS; Consider = Not included in final COS but could be considered based final voting results; No = Voted out in final round of Delphi Survey; Dropped = domain was voted out in an earlier round of Delphi survey for that pain condition. N/A = Domain was not voted on for that pain condition.
The number of respondents for each group represents those who participated in at least one round of the Delphi. Some individuals were invited to vote in multiple groups due to having experience with multiple pain categories, therefore the totals have duplicate votes since some individuals voted in multiple categories.