Nonsurgical management of hallux valgus: findings of a randomised pilot and feasibility trial

Table 2 Summary of feasibility outcome measures and thresholds

Feasibility construct	Outcome measure	Predetermined threshold	Result	Achieved?
Demand	Recruitment rate	6 participants per month	2.8	No
Demand	Conversion rate	≥ 75%	68%	No
Acceptability	MOS questionnaire	≥ 75% of the intervention group score more than 5/10 for each of questions 1–6	28–93%	Partly^a
Adherence
Footwear/orthoses	Orthotimer^® sensor	≥ 75% of participants wear the footwear/orthoses for an average of ≥ 5 h per day	14%	No
Footwear/orthoses	4-weekly diaries		57%	No
Exercise	PhysiTrack^® app	≥ 75% of participants complete at least 24/36 (66%) of the exercise sessions	7%	No
Exercise	4-weekly diaries		43%	No
Adverse events	4-weekly diaries	< 15% and no serious events	64%	Partly^b
Retention rate	Proportion of participants followed up at 12 weeks	≥ 80% retention	82%	Yes

^aOnly 28% thought the footwear was attractive to others, and only 50% judged it be attractive to themselves. Questions 4, 5 and 6 (relating to fit, ease of use and weight) met the criteria
^bAlthough 64% of the sample reported developing pain elsewhere, none were considered serious events and all resolved during the trial

ISSN: 1757-1146