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Table 1 Research progression criteria for continuing to the definitive randomised controlled trial

From: Heavy shoulder strengthening exercise in people with hypermobility spectrum disorder (HSD) and long-lasting shoulder symptoms: a feasibility study

Outcome

Green

Amber

Red

Participant recruitment

Inclusion rate of one participant per general practitioner or physiotherapist every month (approximately n = 6–8/month)

(n < 6 after first month). If recruitment rate falls behind, screening logs and reasons for exclusion will be explored after the first month to adjust eligibility criteria.

No recruitment after 2 months

Completion of the outcome measures

Mean < 120 min to complete all objective outcome measures, and that at least 67% of participants found the duration acceptable.

Between 121 and 150 min, or only 50–66% of participants found the duration acceptable.

> 150 min or < 50% of participants found the duration acceptable

Participant retention

10 or more participants show up at 16-week follow up

Only 6–9 participants show up at 16-week follow up.

Below 6 participants show up at 16-week follow up.

Adherence to exercise intervention

Minimum 75% of participants adhering to at least 75% of exercise sessions.

Only 50–75% of participants adhering to 50–75% of exercise sessions.

< 50% of participants adhering to < 50% of exercise sessions

Adverse events

No or minor adverse events with no participants discontinuing the study

Minor or serious adverse events leading to 2 or less participants discontinuing the study

Serious adverse events leading to > 2 participants discontinuing the study

  1. Research progression criteria were based on a traffic light system of green (go), amber (amend) and red (stop) [24]. Results of these research progression criteria were evaluated by the research group, who recommended whether to proceed with the definitive randomised controlled trial, and which amendments that needed to be made before proceeding