Evaluation of guidelines for the referral and management of breast disorders: a pragmatic practice-based randomised trial

ISRCTN	ISRCTN56750811
DOI	https://doi.org/10.1186/ISRCTN56750811
Secondary identifying numbers	PSI02-69

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Clare Wilkinson
Scientific

University of Wales College of Medicine
Academic Unit
Gwenfro Building
Wrexham Technology Park
Wrexham
LL13 7YP
United Kingdom

Phone	+44 (0)1978 316236
Email	c.wilkinson@bangor.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Other
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Evaluation of guidelines for the referral and management of breast disorders: a pragmatic practice-based randomised trial
Study objectives	The aim of this project is to implement and evaluate existing national guidelines for referral and management of breast disorders. Evaluation will be via a pragmatic practice based randomised trial. The guidelines include algorithms for the management of breast pain/diffuse lumpiness and breast lumps. A preliminary study will measure women's and GP's perceptions of risk for these presentations and the practical basis for a risk communication package will be developed. This will be followed by a practice based randomised trial in Wales.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Breast cancer
Intervention	Not provided at time of registration
Intervention type	Other
Primary outcome measure	1. Medical Interview Satisfaction Scale 2. SF36 Health Profile 3. Euroqol Health Status Index 4. Cost Utility Analysis 5. Rates of Referral
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/04/1995
Completion date	01/10/1999

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	30 group practices
Key inclusion criteria	30 Group practices
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/04/1995
Date of final enrolment	01/10/1999

University of Wales College of Medicine

Wrexham
LL13 7YP
United Kingdom

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Government

NHS Primary and Secondary Care Interface National Research and Development Programme (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2002	28/11/2019	Yes	No

28/11/2019: Publication reference added.
15/04/2016: No publications found, verifying study status with principal investigator.