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. 2023 Jul 6;25:e46439. doi: 10.2196/46439

Table 1.

Outcome hierarchy.

Outcome Hierarchy
Primary outcomes

Objectively measured physical activity

  1. Accelerometer measures (eg, daily time spent in moderate to vigorous physical activity)

  2. Pedometer (eg, outcomes such as step counts)

  3. Any other outcome measure related to objectively measured physical activity

Objectively measured physical function

  1. The 6-minute walk test

  2. Incremental shuttle walk test

  3. Any other outcome measure related to daily function (eg, Chair stand test)
Secondary outcomes

Subjectively measured physical activity

  1. The Global Physical Activity Questionnaire

  2. The Physical Activity Scale for the Elderly questionnaire

  3. The International Physical Activity Questionnaires, long form or short form

  4. Any other outcome measure related to subjectively measured physical activity

Subjectively measured physical function

  1. The 36-item Short-Form Health Survey, as the Physical Function subscale or the Role Function subscale

  2. Any other self-reported measure of physical function

Depression

  1. The Beck Depression Inventory

  2. Any other depression questionnaire (eg, HADSa depression subscale)

  3. Any other assessment of depression (eg, clinical assessment)

Anxiety

  1. State-Trait Anxiety Inventory questionnaire

  2. Any other anxiety questionnaire (eg, HADS anxiety)

  3. Any other assessment of anxiety (eg, clinical assessment)

Health-related quality of life

  1. The EQ-5D questionnaire

  2. Any other generic health-related quality-of-life questionnaires

  3. Disease-specific health-related quality-of-life questionnaires (eg, the Minnesota Living with Heart Failure questionnaire)

Adverse events (nonserious and serious)

  1. Extracted if reported in the included trials accordingly to the FDAb recommendations of nonserious and serious adverse events [29]. Adverse events were defined accordingly to FDA as “any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal [investigational] product whether or not considered related to the medicinal [investigational] product and grouped in serious adverse events such as death, hospitalization, disability or permanent damage, and nonserious adverse events such as pain, falls and fatigue” [29].

aHADS: Hospital Anxiety and Depression Scale.

bFDA: Food and Drug Administration.