Purpose:Clinicians in charge of Stress Urinary Incontinence (SUI) patients miss specific tools supporting pragmatic treatment decision taking into account the complexity of perceived handicap and patients expectations. Our aim was to develop a standardized global medical judgement scale to assess therapeutic response and support medical decision.

Method: The concepts useful to assess SUI treatment outcomes were identified from two independent sources: literature review and clinicians' experience (30 open interviews). A test version of the Pragmatic Assessment Form (PAF) was developed. Eight clinicians comprehensively covering various perspectives of professional medical carers in SUI were interviewed, following a semi-structured interview guide assessing the relevance, comprehensiveness and validity of the concepts covered, accessibility to source information, clarity of item wording and response choice, easiness to use in clinical practice, applicability to the various situations in real life, appropriate level of guidance to form global medical judgement. The PAF was updated according to the comments received. Content validity was further assessed by 10 SUI patients, to quote the concepts covered by the PAF for relevance, reliability, importance, and applicability in routine clinical practice.

Results: Eight broad concepts covering symptom and functional status, impact on activities of daily life, well-being, coping, satisfaction and expectations were identified as relevant independent outcomes and included in the test PAF. Out of 8 clinicians interviewed, 7 found the PAF complete, relevant and specific to SUI, clear and valid to support clinical judgement. The clinicians were happy to have an assessment guide to support judgement, but did not wish to have a formal scoring procedure to support decision. The balance between treatment benefit, undesirable effects and constraints was made more explicit. An additional item describing patients' intentions was developed. After final validation by 10 SUI patients, the pilot version of the PAF was issued in a doubleA4 format, including instructions for use.

Conclusions: This new instrument is a short, simple, pragmatic composite tool which aims at helping the clinicians to easily manage complexity of patients perspective. It provides a comprehensive coverage of relevant outcomes in SUI to assess therapeutics and support medical decision making. This instrument allows two levels of concept elicitation, one, pragmatic, suitable for clinical practice, and one, standardized, suitable for clinical research. Its properties will be assessed in a specific validation study.