Hypothesis / aims of study
For people with intractable incontinence, products to contain leakage are fundamental to health-related quality-of-life, but many users and healthcare professionals are unaware of the options. Despite the potential harm associated with poorly managed leakage (e.g. social isolation, carer workload and skin-damage), little evidence-based guidance on choosing products exists (1,2). Therefore, the aim of this study was to develop and evaluate a continence product decision aid (CPDA) to support product users and clinicians to make continence product decisions.
Study design, materials and methods
Informed by international patient decision aid development guidance (3), work was undertaken in 4 phases.
I. Evidence and expert opinion: Literature review and consultation with specialist continence clinicians to establish the evidence base.
II. Prototype: Draft CPDA developed with iterative feedback from continence specialists (n=7).
III. Alpha testing: CPDA materials and a feedback questionnaire were provided to product users (n=10) with incontinence experience and specialist and non-specialist clinicians (n=11) to assess usability and acceptability.
IV. Beta testing: Field testing with men (n=50) post-radical prostatectomy to evaluate usability and acceptability. Men received usual care, with (n=34) or without (n=16) the CPDA. Participants completed the Decision Conflict Scale (range of 0-100; scores lower than 25 are associated with confident decision-making and scores of 37.5 or higher are associated with decision delay or implementation delay) and a bespoke feedback questionnaire.
An algorithm differentiating patients by sex, mobility, carer dependency, cognition and type/level of leakage, leading to 24 user groups was developed. For each group, a booklet containing a ‘traffic-light’ option grid and product information sheets guides appropriate product choice (Figure 1). All but one of the users and all clinicians interviewed stated that the CPDA provides a useful guide for product choice. The men who bought products and received the CPDA reported more confidence in their knowledge, clearer values, and felt more supported and less uncertain than men who did not receive the CPDA (Figure 2). In particular, men stated that they had greater confidence in their knowledge of product options available to them, the risks and benefits of those options and what is the best choice for their own circumstances. There was a difference in the percentage of participants reporting that they knew the risks or side effects of products if they received the CPDA (71%) compared to if they did not receive the CPDA (13 %).
Interpretation of results
The study highlighted the complexity of choosing the optimal continence management products caused by the combination of variation in incontinence, co-morbidities, daily activities and personal preferences. The CPDA was found to be usable, acceptable and to reduce product choice decision conflict with men post-radical prostatectomy.