Chapter 5 130 each item and linearly transformed into a range from 0 to 100 where a higher score denotes a better level of functioning. The Proctoprom, a patient related outcome measurement was developed by Van der Mijnsbrugge et al.,41 to assess the impact of proctologic complaints on different domains of a patient’s life and evaluates the effect of treatment. This questionnaire consists of 5 items using a scale of 0-10 (0 = no complaints and 10 = maximum complaints), with a maximum score of 50. All items but one (item 4) are mandatory. An overview of the assessment and questionnaires is shown in Table 1. Table 1. Assessment schedule and questionnaires Baseline 8 wk. 20 wk. 1 year Digital rectal examination (surgeon/PFPT) • • • • Proctoscopy/Endoanal ultrasound (surgeon)1 • • • Surface-electromyography (s-EMG) (PFPT) • • • • Balloon expulsion test (BET) (nurse) • • • Proctoprom • • • • Quality of Life (RAND-36) • • • • VAS-pain • • • • 1. if neccessary Trial interventions The description of the intervention follows the Template for Intervention Description and Replication (TIDieR) checklist (Appendix 2). Referral Patients are referred to an extra mural private practice, preferably nearby patients’ home address. The pelvic floor physical therapists providing the treatment are all certified and trained. They all receive the treatment protocol prior treatment and have access to peer consultation when needed. The modalities composing the treatment protocol were selected to reflect clinical practice in the Netherlands. Interventions At baseline all patients receive information about the pelvic floor and related symptoms, defecation physiology, behavioural modifications and lifestyle advice and continue ointment, fibers and/or laxatives.
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