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Table 2 Time points at which outcomes are assessed

From: Progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of rotator cuff disorders: statistical analysis plan for the Getting it Right: Addressing Shoulder Pain (GRASP) 2 × 2 factorial multicentre randomised controlled trial

Outcome

Measurement

Time point

Primary

 Pain and function

Shoulder Pain and Disability Index (SPADI) 13-item total scale [16, 17]

0, 8 weeks, 6 months, 12 months

Secondary

 Pain

Shoulder Pain and Disability Index (SPADI) 5-item subscale [16, 17]

0, 8 weeks, 6 months, 12 months

 Function

Shoulder Pain and Disability Index (SPADI) 8-item subscale [16, 17]

0, 8 weeks, 6 months, 12 months

 Health-related quality life

EQ-5D-5L score [18]

0, 8 weeks, 6 months, 12 months

 Psychological factors

Fear Avoidance Belief Questionnaire physical activity 5-item subscale [19]

Pain Self-Efficacy Questionnaire (short form) insomnia [20]

0, 8 weeks, 6 months, 12 months

 Sleep disturbance

Insomnia Severity Index [21]

0, 8 weeks., 6 months, 12 months

 Global Impression of Treatment

Patient-rated Likert scale [22]

8 weeks, 6 months, 12 months

 Return to desired activities

Patient-reported return to desired activities, including work, social life and sport activities

8 weeks, 6 months, 12 months

 Exercise adherence

Patient-reported adherence to exercise

8 weeks, 6 months, 12 months

 Work disability

Sick leave (days)

8 weeks, 6 months, 12 months

 Healthcare use

NHS outpatient and community services (e.g., GP, additional physical therapy)

NHS inpatient and day case (e.g., radiography, magnetic resonance imaging)

Private health care services

8 weeks, 6 months, 12 months

 Out-of-pocket expenses

Patient-related out-of-pocket expenses recording form

8 weeks, 6 months, 12 months