SF-36 to assess impact of chest-contouring surgery
Research type
Research Study
Full title
Assessment of impact of Trans Male chest contouring surgery on quality of life as measured by the Short Form-36
IRAS ID
164481
Contact name
Chloe Wright
Contact email
Sponsor organisation
Pennine Acute Trust
Duration of Study in the UK
0 years, 4 months, 1 days
Research summary
Background
For complete assessment of the benefits of an intervention it is essential to provide evidence of the impact on the patient in terms of health status and health related quality of life (HRQoL). The best determiners of this are the patient themselves. When these measures are assessed by the patient, they are a patient-reported outcome measure (PROM). Systematic review of the published literature demonstrates that there are no validated patient-reported-outcome-measures (PROM) for Trans Male individuals undergoing chest contouring surgery.
865 generic measures of HRQoL have been described. The Short Form-36 (SF-36) is the most widely evaluated of these measures.
In the absence of PROMs specific to this patient-group, the primary objective of this study is to utilise the SF-36 to assess the impact of chest contouring surgery on HRQoL. A secondary objective is to assess the relevance and applicability of this tool for this patient-group.Methods: The SF-36 version 2, acute form, will be administered pre-operation, at 2-4 weeks post-operation and at 3-6 months post-operation. At each administration of the survey, participants will also be asked their views on the relevance of the questions.
REC name
East of England - Essex Research Ethics Committee
REC reference
15/EE/0470
Date of REC Opinion
11 Dec 2015
REC opinion
Favourable Opinion