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Background  The aim of the LIFELAX randomised controlled trial (diet and  life style vs.  lax atives in the management of chronic constipation) is to develop and evaluate a cost effective intervention to promote diet and lifestyle in the treatment and management of chronic constipation for older people in Primary Care. Constipation affects the quality of life in around 20% of older people in the community. In the 65 years plus population, a significant proportion of men and women both living in institutions (81% and 75% respectively) and free living (30% and 37% respectively) use laxatives.  Approximately £42 million is spent each year on prescribed laxatives in England in addition to laxatives purchased over the counter. Although bowel problems are often multifactorial, diet and lifestyle have an extremely important role in their management. This paper describes one aspect of the main study, the development and piloting of the Patient information leaflets (PILs).    Methods  Following review of the literature and interviews with practitioners and patients, 8 PILs were designed on: constipation, activity, bowel health, fruit and vegetables, fibre, fluid, alternative therapies and laxatives. To check the patient's understanding of terms used in the PILS and the clarity and accessibility of the information understanding, cognitive interviews (CI) were used with nine patients (selected from 3 GP surgeries), aged ≥ 55 years, who had received ≥ 3 prescriptions of laxatives over 12 months. Interviews were recorded and transcribed.    Results  Changes made following the CI process included the lay-out, words used (e.g. 'exercise' was changed to 'activity', 'gut motility' changed to 'bowel movement') and descriptions and examples were adapted to be more appropriate for the target population.    Conclusion  Pilot testing with CIs resulted in improvements in the PILs, which emphasises the need to pilot PILs with the target population before use. The techniques employed are relatively inexpensive and could be routinely used when preparing literature for research or clinical use including those intended for use with healthcare professionals and patients.

Development of a series of patient information leaflets for constipation using a range of cognitive interview techniques: LIFELAX