Secondary outcomes
orthosis, injuries
ADVERSE EVENTS, RECRUITMENT
Of the two patient recruitment methods, physiotherapy referral screening provided 49 participants, whereas only 1 participant was recruited from GP record screening (having identified 15 potentially eligible people).The outcome measure return rate at six weeks was 59% (66% online vs 36% paper); at 12 weeks was 65% (68% online vs 55% paper); at six months was 81% (28/38 online versus 5/10 paper, plus four minimum data telephone collections and two paper returns after requests from participants who had originally opted for online). 27/39 (69%) of 6-month data returns included grip-strength measurements using the Squegg device.The descriptive analysis of the patient-reported outcome measures is presented in Descriptive analysis of patient-reported outcome measures.The external responsiveness of individual outcome measures, correlated against the GPE-11 anchor, is displayed in External responsiveness of outcome measures to GPE-11 anchor.Exercise adherence score (median (IQR values)), measured using the EARS questionnaire, at 12 weeks was 15.5 (9.5–21.5) in the OPTimisE group compared to 16 (12–20.75) in the usual care group; at six months 13 (8-21) and 16 (12-23) respectively. Only 6/18 (33%) participants who received the OPTimisE intervention returned their exercise diaries, reporting median adherence of 81% (IQR 74-93).The review of clinical report forms from the usual care group showed that all patients received basic advice about LET and were taught exercises. Few were provided with advice related to lifestyle factors or modifiable risk factors. Exercises often lacked a clear dosing strategy or progression. Three patients received manual therapy treatment from the physiotherapist and one was taught to perform self-administered manual therapy. No patients were provided with an orthosis, although two patients requested advice on how to fit orthoses that they had previously purchased themselves.No related adverse events were reported. One participant was involved in a road traffic collision during their period of treatment. They did not sustain serious injuries and were able to continue their trial participation.From the qualitative interviews, patient and physiotherapist participants both found the OPTimisE intervention to be acceptable and physiotherapists perceived key differences to usual care, related to exercise selection, dose, educational content and provision of the orthosis. The slowing of recruitment after month seven was perceived to be due to a change in referral patterns, with more patients with LET managed by First Contact Practitioners (FCPs)[