Table II.
Stage | Setting up* | Delivery | Review | Reporting (CONSORT) | |||
---|---|---|---|---|---|---|---|
Initial care | Sling care information leaflet designed | Included in trial materials | Survey | Initial care provided; standardisation | |||
Physiotherapy | Physiotherapy protocol – development to reflect basic standard practice, included survey; PTs attend site set-up visit; assigned contact PT to co-ordinate trial processes | Protocol included in trial participant materials; emphasis on provision for all participants | Feedback to trial PT contact; physiotherapy treatment logs; end of treatment form | Participant flow diagram; attendance and extent of physiotherapy; data for cost analysis; description of rehabilitation; standardisation of basic physiotherapy; use of additional interventions, including referral to occupational therapy; notice of adverse events | |||
Home exercises | Instruction for locally produced exercise sheets | Part of protocol; part of site set-up | Feedback to physiotherapy contact; physiotherapy treatment logs | Standardisation of treatment; additional measure of patient activity | |||
Data collection | Design of forms; assigned contact PT to co-ordinate data collection | Physiotherapy treatment logs and end of treatment forms are part of trial materials for recruited patients; forms circulated for completion during care pathway and collated by physiotherapy contact for dispatch to trial office | Housekeeping of returned forms; consistency checks | Data within used as above | |||
* Common to all these was the central role, including as a source of advice, of the physiotherapy contact for the trial. PT, physiotherapist