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Table 2 Traffic light progression criteria

From: Co-designed neck exercise (EPIC-Neck) vs usual exercise care for people with chronic non-specific neck pain: protocol for a randomised feasibility study with process evaluation

 

Green

Amber

Red

Measurement

Delivery fidelity — the EPIC-Neck programme being delivered as intended

No areas of concern identified (scores of ≥ 3 for most checklist items)

Minor problems identified (scores between 1.5 & 3 for ≥ 50% of checklist items)

Major problems identified (scores of < 1.5 for most checklist items)

EPIC-Neck appointment audio recordings and observations

Acceptability — the degree to which people delivering and receiving the EPIC-Neck programme consider it to be appropriate. Measured qualitatively and quantitatively using Sekhon’s acceptability of healthcare intervention domains [41, 42]

Mean acceptability score of ≥ 4 and no areas of concern identified in qualitative interviews

Mean acceptability score 3 and/or minor problems identified in qualitative interviews

Mean acceptability score ≤ 2 and/or major problems identified in qualitative interviews

Acceptability questionnaire at 3 and 6 months [42]. Scores of 4 and above are acceptable, 2 and below are unacceptable, and 3 is neutral

EPIC-Neck patient participant interviews at 4 months

Interviews with physiotherapists delivering EPIC-Neck programme after the majority of treatment has been completed

Contamination — the EPIC-Neck programme and usual care exercise are sufficiently different. Measured by the presence of the EPIC-Neck Programme Behavioural Logic Model or Biopsychosocial Exercise Prescription Framework components within usual exercise care

No EPIC-Neck Programme Behavioural Logic Model or Biopsychosocial Exercise Prescription Framework components present within usual exercise care

Minor problems identified

Major problems identified

Usual exercise care appointment audio-recording and observations

EPIC-Neck appointment audio-recordings and observations

Interviews and questionnaire with physiotherapist delivering usual exercise care after the majority of treatment has been completed

Mean recruitment rate — the mean rate of recruitment per month. Threshold criteria determined by calculating the time to recruit to an estimated sample size of 248 in a definitive trial using 5 musculoskeletal services [17]. Green would be < 18 months, amber would be 18–30 months, and red would be > 30 months

 ≥ 3 per month

1–2 per month

 ≤ 1 per month

Recruitment rates

Retention rate — the percentage of patient participants completing and returning the Neck Disability Index at 6-month follow-up

 ≥ 80%

70–79%

 < 70%

Completed and returned 6-month follow-up questionnaires

  1. Green, no areas of concern
  2. Amber, minor problems that require attention before continuing to a definitive trial
  3. Red, major problems that require urgent attention before continuing to a definitive trial