Objectives . A rigorous approach to developing, delivering and documenting
rehabilitation within randomised controlled trials of surgical interventions
is required to underpin the generation of reliable and usable evidence.
This article describes the key processes used to ensure provision
of good quality and comparable rehabilitation to all participants
of a multi-centre randomised controlled trial comparing surgery
with conservative treatment of proximal humeral fractures in adults. Methods . These processes included the development of a patient information
leaflet on self-care during sling immobilisation, the development
of a basic treatment physiotherapy protocol that received input
and endorsement by specialist physiotherapists providing patient
care, and establishing an expectation for the provision of home
exercises. Specially designed forms were also developed to facilitate
reliable reporting of the physiotherapy care that patients received. Results. All three initiatives were successfully implemented, alongside
the measures to optimise the documentation of physiotherapy. Thus,
all participating sites that recruited patients provided the sling
immobilisation leaflet, all adhered to the physiotherapy protocol
and all provided home exercises. There was exemplary completion
of the physiotherapy forms that often reflected a complex patient
care pathway. These data demonstrated equal and high access to and
implementation of physiotherapy between groups, including the performance
of home exercises. Conclusion . In order to increase the validity and relevance of the evidence
from trials of surgical interventions and meet international reporting
standards, careful attention to study design, conduct and reporting
of the intrinsic rehabilitation components is required. The involvement
of rehabilitation specialists is crucial to achieving this. Cite this article: Bone Joint Res 2014;3:335–40