Research project

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Title: CaTLET (Cancer Trials Leaflet Evaluation Tool) - An evaluation of information leaflets for patients entering cancer trials. This was a pilot study producing provisional findings: further development is planned.

Project timescale: From 01 September, 2000 to 01 January, 1970
(Added to website on: 07 February, 2005 - Date last updated: 20 April, 2007)

Source of funding:

Aims: To develop, in a partnership between the Faculty of Medicine, University of Leicester, and the NHS Centre for Health Information Quality (CHIQ), a tool (CaTLET) for evaluating information leaflets given to patients who are being asked to participate in cancer trials. To use CaTLET and a previously validated instrument (DISCERN) to appraise a sample of leaflets currently used in cancer trials.

Research designs used:
Study of views/experiences
Systematic review

Methods used to collect data:
Documentary analysis
Focus groups
Questionnaire survey

Research project description: CaTLET is a pilot project and it is anticipated that this will lead on to a generic version TriLET (Trial leaflet Evaluation Tool) which will be developed and validated in a more rigorous project. The setting for this research was the Faculty of Medicine at the University of Leicester, and hospitals in the Leicester area. An evaluation tool, modeled on the DISCERN instrument format, was drafted, initially based on quality criteria for patient information developed by CHIQ and a literature review of patients` preferences for information when entering clinical trials. This draft version was then sent out for consultation with a range of patients` voluntary organisations, patients` advocates, ethics committee representatives, oncologists, information specialists, and the Consumers` Advisory Group for Clinical Trials. The comments received during the consultation period were synthesised and used to modify the draft version. The final version in this pilot project was named CaTLET . The test-retest reliability and inter-rater reliability of the instrument was established by a multi-disciplinary team. CaTLET, together with the DISCERN instrument, was then used to appraise more than 50 patient information leaflets currently being used in cancer trials in a variety of centres in the UK. Results suggested large variability in the quality of information leaflets given to patients and indicated areas where significant improvements could be made. Many patient information leaflets fail to meet basic quality criteria and many do not address patients` needs as fully as they should.

Stages at which the public were involved:
Designing the research instruments
(eg questionnaires, patient information sheets)
Disseminating research
Prioritising topic areas
Planning the research
Managing the research

Description of public involvement in research stages: Integral throughout by a managed, iterative process.

Training and support provided for either members of the public or researchers involved in the project:

Examples of ways the public have made a difference to the research project: Involvement of members of the public throughout, as representative users of patient information leaflets, has been crucial in the iterative process with health professionals, in order to determine what is required in those leaflets in order to improve the informed consent process, and the manner in which it should be presented.

Evaluating the impact of public involvement in the research:

Details of publications or reports resulting from the research: Lees N, Dixon-Woods M, Young B, Heney D, Thornton H. CaTLET: Evaluation of information leaflets for patients entering cancer trials. PSYCHO-ONCHOL. 10(3): 266 - May June 2001. Oral Presentation at British Psychosocial Oncology Group Annual Meeting 2000 Further development of this tool is planned: this will be reported when findings are available.

Was/is your project user controlled: Not Known

For further information on the project, please contact:
Hazel Thornton
1. Involved consumer/researcher 2. Chair of involved consumer group
The Consumers' Advisory Group for Clinical Trials
31 Regent Street
01206 728 178


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