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Table 3 Measures, assessment, expected scaling, and measurement occasions

From: Non-inferiority of a hybrid outpatient rehabilitation: a randomized controlled trial (HIRE, DRKS00028770)

Outcome

Source and reference

Scaling

Scoring

Measurement time points

    

Start of rehabilitation

End of rehabilitation

3 months follow-up

12 months follow-up

Primary outcome

 Pain self-efficacy

FESS [25]

Continuous

10 to 60

x

x

x

x

Secondary outcomes

 Health and health-related outcomes

  Current health status

COPSOQ-Item [30]

Continuous

0 to 10

x

x

x

x

  Mental health

IRES-24 [31]

Continuous

0 to 10

x

x

x

x

  Functional capacity

IRES-24 [31]

Continuous

0 to 10

x

x

x

x

  Pain

IRES-24 [31]

Continuous

0 to 10

x

x

x

x

  Action-oriented coping

FESV [32]

Continuous

4 to 20

x

x

x

x

  Cognitive restructuring

FESV [32]

Continuous

4 to 20

x

x

x

x

  Subjective coping competence

FESV [32]

Continuous

4 to 20

x

x

x

x

  Mental distraction

FESV [32]

Continuous

4 to 20

x

x

x

x

  Counter activities

FESV [32]

Continuous

4 to 20

x

x

x

x

  Relaxation

FESV [32]

Continuous

4 to 20

x

x

x

x

  Motivational self-efficacy

3 Items, based on [33]

Continuous

3 to 12

x

x

  

  Disorder and treatment knowledge

Own development

Continuous

0 to 50

x

x

x

x

  Self-efficacy in practicing gained knowledge

Own development

Continuous

0 to 20

x

x

x

x

  Electronic health literacy

eHEALS [34]

Continuous

8 to 40

x

x

x

x

  Self-informing behaviour

Own development

Ordinal

1 to 6

x

 

x

x

  Adherence to exercises

Own development

Ordinal

1 to 5

  

x

x

  Adherence to knowledge

Own development

Ordinal

1 to 5

  

x

x

  Work functioning outcomes

  Work ability in relation to work demands

Work Ability Index [35, 36]

Continuous

2 to 10

x

x

x

x

  Self-rated work ability

Work Ability Index [37, 38]

Continuous

0 to 10

x

x

x

x

  Current sickness absence

Own development

Binary

 

x

x

x

x

  Sickness absence in weeks

Own development

Continuous

1 to 13 or 26

x

 

x

x

  Employment

Own development

Binary

 

x

 

x

x

  Employment contract

Own development

Nominal

 

x

   

  Shift working

Own development

Nominal

 

x

   

  Patient satisfaction

  Patient satisfaction

ZUF-8 [39]

Continuous

8 to 32

 

x

  

  System usability (intervention group only)

SUS [40]

Continuous

0 to 100

 

x

  

  Overall assessment of the Caspar application (intervention group only)

Based on Thielsch [41]

Ordinal

1 to 5

 

x

  

  Frequency of Caspar use (intervention group only)

Own development

Ordinal

1 to 6

 

x

  

  Type of electronic device (intervention group only)

Own development

Nominal

  

x

  

Rehabilitation aftercare

  Physical activity

Own development

Nominal

   

x

x

  Aftercare programs

Own development

Nominal

   

x

x

  Reasons for non-use of aftercare

Own development

Nominal

   

x

x

Other outcomes

 Sociodemographic information

Own development

Various (year of birth, gender etc.)

 

x

   

 Treatments during the rehabilitation program

Standardized discharge report [42], according to the classification of therapeutic services [43]

Continuous (minutes or hours)

  

x