Developing, delivering and documenting rehabilitation in a multi-centre randomised controlled surgical trial: experiences from the ProFHER trial

Hdl Handle:
http://hdl.handle.net/10149/337871
Title:
Developing, delivering and documenting rehabilitation in a multi-centre randomised controlled surgical trial: experiences from the ProFHER trial
Authors:
Handoll, H. H. G. (Helen); Goodchild, L. (Lorna); Brealey, S. D.; Hanchard, N. C. A. (Nigel); Jefferson, L. (Laura); Keding, A.; Rangan, A. (Amar)
Affiliation:
Teesside University. Health and Social Care Institute.
Citation:
Handoll, H. H. G., Goodchild, L., Brealey, S. D., Hanchard, N. C. A., Jefferson, L., Keding, A., Rangan, A. (2014) 'Developing, delivering and documenting rehabilitation in a multi-centre randomised controlled surgical trial: experiences from the ProFHER trial' Bone and Joint Research; 3 (12): 335-340
Publisher:
British Editorial Society of Bone and Joint Surgery
Journal:
Bone and Joint Research
Issue Date:
Dec-2014
URI:
http://hdl.handle.net/10149/337871
DOI:
10.1302/2046-3758.312.2000364
Additional Links:
http://www.bjr.boneandjoint.org.uk/cgi/doi/10.1302/2046-3758.312.2000364
Abstract:
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.
Type:
Article
Language:
en
Keywords:
rehabilitation; pragmatic randomised control trial; shoulder fracture; research design
ISSN:
2046-3758
Rights:
Author can archive publisher's version/PDF. For full details see http://www.sherpa.ac.uk/romeo [Accessed: 06/01/2015]

Full metadata record

DC FieldValue Language
dc.contributor.authorHandoll, H. H. G. (Helen)en
dc.contributor.authorGoodchild, L. (Lorna)en
dc.contributor.authorBrealey, S. D.en
dc.contributor.authorHanchard, N. C. A. (Nigel)en
dc.contributor.authorJefferson, L. (Laura)en
dc.contributor.authorKeding, A.en
dc.contributor.authorRangan, A. (Amar)en
dc.date.accessioned2015-01-06T14:47:20Z-
dc.date.available2015-01-06T14:47:20Z-
dc.date.issued2014-12-
dc.identifier.citationBone and Joint Research; 3 (12): 335-340en
dc.identifier.issn2046-3758-
dc.identifier.doi10.1302/2046-3758.312.2000364-
dc.identifier.urihttp://hdl.handle.net/10149/337871-
dc.description.abstractObjectives: 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.en
dc.language.isoenen
dc.publisherBritish Editorial Society of Bone and Joint Surgeryen
dc.relation.urlhttp://www.bjr.boneandjoint.org.uk/cgi/doi/10.1302/2046-3758.312.2000364en
dc.rightsAuthor can archive publisher's version/PDF. For full details see http://www.sherpa.ac.uk/romeo [Accessed: 06/01/2015]en
dc.subjectrehabilitationen
dc.subjectpragmatic randomised control trialen
dc.subjectshoulder fractureen
dc.subjectresearch designen
dc.titleDeveloping, delivering and documenting rehabilitation in a multi-centre randomised controlled surgical trial: experiences from the ProFHER trialen
dc.typeArticleen
dc.contributor.departmentTeesside University. Health and Social Care Institute.en
dc.identifier.journalBone and Joint Researchen
or.citation.harvardHandoll, H. H. G., Goodchild, L., Brealey, S. D., Hanchard, N. C. A., Jefferson, L., Keding, A., Rangan, A. (2014) 'Developing, delivering and documenting rehabilitation in a multi-centre randomised controlled surgical trial: experiences from the ProFHER trial' Bone and Joint Research; 3 (12): 335-340-
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