TABLE 1.
Existing Practice Control Groups
Condition | Description | Stringency | Uniformity | Vulnerability to Unintentional Intensification |
---|---|---|---|---|
Naturalistic | ||||
Inadequate Care (IC) | Inaccessible or poor quality nonstudy care | Low | Trial- Dependent |
Low |
Treatment As Usual (TAU), Usual Care (UC), Routine Care (RC), or Standard Care (SC) |
Typical, normative, nonstudy care | Moderate | Trial- Dependent |
High |
Standard of Care (SOC) | ||||
Individualized (iSOC) | Individualized, state-of-the-art, guideline-adherent nonstudy care |
High | Low | Low |
Uniform (uSOC) | Uniform, state-of-the-art, guideline-adherent nonstudy care |
High | High | Low |
Modified | ||||
Standardized treatment regimen (STR) |
Nonstudy care is standardized for the trial to ensure uniformity of care, and possibly higher quality care |
Moderate to High |
High | Low |
Constrained Usual Care (CUC) | Specific aspects of usual nonstudy care are withheld or discouraged during the trial |
Moderate | Trial- Dependent |
Trial- Dependent |
Enhanced Usual Care (EUC) | ||||
Minimally Enhanced (mEUC) | Nonstudy care is enhanced in minor ways during the trial to address methodological or ethical issues |
Moderate | Trial- Dependent |
Trial- Dependent |
Extensively Enhanced (eEUC) | Nonstudy care is substantially enhanced during the trial to bring it closer to the standard of care |
High | Trial- Dependent |
Trial- Dependent |