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Table 1 Details of included articles

From: Defining usual care comparators when designing pragmatic trials of complex health interventions: a methodology review

Author and date

Subject area

Terms used for usual care

Text defining term(s) used

Angriman et al., 2019 [9]

Critical care

Usual care

Protocolized usual care

Unrestricted usual care

Depending on the clinical situation, usual care may be relatively narrow (e.g., a red blood cell transfusion threshold of 70 g of hemoglobin per liter in general critical care populations) or it may be relatively broad (e.g., the timing of strategies to treat patients with severe hypoxemia, or the amount of fluid given for resuscitation of patients in septic shock). ‘Protocolized’ usual care would select from one of the practice patterns that comprise usual care; unrestricted usual care would not impose any such limits. (page 499)

Applefield et al., 2020 [15]

Critical care

Usual care

Properly designed head-to-head comparisons of contemporary care can improve clinical decision making by better quantifying relative risks and benefits. However, for such research to be informative, at least one arm must be truly representative of current medical practice. Some trials purporting to compare usual care practices may not accurately reflect those practices. (page 110)

Arch and Stanton, 2019 [17]

Psycho-oncology

Usual care

Within psycho-oncology trials, usual care (UC) represents a common and important control condition. When we need to know whether a new psycho-oncology intervention improves care or cost beyond the offerings already in place, UC represents the most logical control condition. (page 1592)

Arean and Alvidrez, 2002 [26]

Psychotherapy

Usual care

Treatment as usual

Because effectiveness research is generally concerned with the effectiveness of new interventions compared to existing treatment, the typical comparison condition in this research is usual care, sometimes called treatment as usual (TAU). (page 63)

Barkauska et al., 2005 [12]

Experimental studies

Usual care

Devised usual care

Usual carebecause of ethical concerns, health care providers are reluctant to discontinue a usual treatment unless a new intervention is proven to be more beneficial. In such cases, investigators may need to add the experimental intervention to treatments already being provided to all participants. (page 354)

Devised usual carea usual treatment, typical of the approaches used in the field and administered in a manner parallel to the experimental intervention. (page 355)

Biesecker et al., 2020 [27]

Genetic counselling

Usual care

usual care’ to refer to the standard care offered in such a control group. (page 43)

Brigham et al., 2009 [28]

Behavioural interventions for substance abuse

Treatment as usual

in this paper we discuss treatment as usual as the standard practice of the community treatment providers. (page 4)

Dawson et al., 2009 [16]

Clinical trial design

Usual care

We use the term “usual care” to describe the care commonly given by practitioners in a community to avoid any legal or normative implications of the term ‘‘standard of care.’’ (page 1)

Degenholtz et al., 2002 [4]

Suicide Prevention

Treatment as usual

PROSPECT randomly assigns practices to either an intervention arm (which includes assessment and care plan recommendation by a mental health specialist) or to a TAU arm, in this case consisting of usual medical care with the addition of screening and assessment services. (page 44)

Freedland et al., 2011 [10]

Trials of Behavioural interventions

Existing practice control conditions

Treatment as usual

Usual care

Enhanced usual care

Constrained usual care

Standardized treatment regimen

Standard of care

Uniform or protocol-driven standard of care

individualized standard of care

Inadequate care

Existing practice (EP) control conditions are used to compare experimental interventions to existing treatments or clinical practices. (page 3)

Treatment as usual (TAU) control groups are used to compare experimental interventions to treatments that are already used in clinical practice…Usual care (UC) is a roughly equivalent term that is used much more often than TAU in medical trials and in behavioral medicine. (page 3)

Enhanced usual care (EUC) condition, usual care is systematically improved by the research protocol to overcome ethical or methodological problems that would accompany ordinary UC. (page 3)

Constrained usual care (CUC), in which nonstudy care is restricted in some way. (page 3)

Standardized treatment regimen (STR), in which the same clinical care or treatment(s) are administered in the same way to all participants. Standardization does not necessarily mean that every patient receives identical treatment. Instead, each patient may be treated according to a standardized protocol or care path. (page 3)

In standard of care (SOC) control groups, participants receive state-of-the-art, evidence based, guideline-adherent clinical care. SOC is a naturalistic condition when patients are recruited from settings that provide it routinely… SOC may have to be imposed by enhancement of usual care when patients are recruited from less stellar settings. (page 3)

A uniform or protocol-driven standard of care (uSOC) produces the best clinical outcomes for some conditions, but an individualized standard of care (iSOC) is best for others. (page 3)

The most problematic EP control condition might be called inadequate care (IC), reflecting the inferior healthcare services to which underserved, uninsured, or captive patient populations may be relegated. (page 3)

Macklin and Natanson, 2020 [29]

Critical care

Usual care

usual care”— current treatments clinicians use in caring for patients. (page 31)

Mohr et al., 2009 [30]

Trials of psychological interventions

Treatment as usual

Enhanced treatment as usual

A TAU control uses the routine intervention(s) ordinarily provided by clinicians in the settings from which participants are recruited. (page 279)

The outcomes of TAU may also include variability from sources other than the treatment itself… These unwanted sources of variance can be limited by standardizing them across treatment arms. For example, standardizing the identification of study participants across treatment arms… Such ‘enhanced’ TAU conditions can focus control on treatment effect. (page 279)

Silverman and Miller, 2004 [31]

Critical care

Standard care

Unrestricted standard of care control group

Protocolized control groups

We use the phrase “standard care” practices to refer to routine intensive care unit practices … such practices represent critical care treatments that physicians currently provide to their patients, making them the normative baseline to which other proposed strategies should be compared. We use the phrase “standard of care control group” to refer to a control group that represents the range of standard practices. (page 853)

Some critical care RCTs compare an experimental strategy with a control group representing the broad range of standard practices in which the selection of treatment for individual patients is at the discretion of the attending physicians. We call this type of control group an unrestricted standard of care control group. (page 853)

Due to the variations in standard practices and multiplicity of interventions used in critical care practice, many critical care trials impose constraints on study and nonstudy interventions in both the experimental and control groups. Accordingly, subjects in the control groups are managed according to protocols that specify and restrict the parameters of standard practices… Depending on the extent of variation in standard practices and the nature of the constraints imposed by a protocol on these practices, protocolized control groups may differ in the extent to which they represent standard of care practices. (page 854)

Spirito et al., 2002 [32]

Suicide prevention

Treatment as usual

The comparison groups used in these studies varied, and in fact, two studies used a no-contact control group. Almost half (n = 8) of the studies randomized comparison group patients to treatment-as-usual (TAU) in the community, that is, treatments that adhere to some community standard of acceptable practice. (page 41)

Thompson and Schoenfeld, 2007 [2]

Trials of nonpharmacologic interventions

Usual care

the terms “best current” therapy or “standard of care” are problematic as they imply a uniform or proven practice standard. We prefer the descriptive term “usual care” to describe de facto clinical care without any value judgment. (page 577)

Young et al., 2020 [33]

Type 2 diabetes

Usual care

the term usual care (also referred to as routine care, control case, or standard treatment) describes a wide spectrum of care practices. (page 126)