Translation and validation of the international consultation on incontinence questionnaire-Bowel in Danish men and women with pelvic floor disorders.

BACKGROUND: We lack a comprehensive validated Danish questionnaire to evaluate symptoms and bother regarding anal incontinence (AI). The International Consultation on Incontinence Questionnaire-Bowel (ICIQ-B) is an internationally recommended questionnaire containing 21 items, of which 17 are scored in three subscales: bowel pattern, bowel control, and quality of life. AIMS: To translate the ICIQ-B into Danish and to validate the Danish version in pelvic floor disorder (PFD) patients with and without AI. METHODS: The ICIQ-B was translated by a panel of healthcare professionals followed by cognitive interviews with PFD patients attending an outpatient clinic. Revisions were undertaken using an iterative process, and a backward translation was performed for the final version. Pretesting and test-retest of the ICIQ-B were done online and administrated together with the St. Mark's score. Content, structural, convergent and discriminant validity were assessed, followed by an evaluation of relative and absolute reliability, including the smallest real difference (SRD). RESULTS: Thirty cognitive patient interviews were performed, resulting in three revisions. The Danish ICIQ-B was found to be comprehensible and relevant but lacked items addressing the psychological impact of bowel problems. The ICIQ-B was completed online by 227 PFD patients with and without AI. The structural validity of the bowel pattern subscale could not be retrieved. Patients indicating AI had significantly higher ICIQ-B and St. Mark's scores than patients without AI, and ICIQ-B subscale scores correlated moderately with St. Mark's scores. Internal consistency was good except for the bowel pattern subscale. Seventy-six patients completed test-retest. Relative reliability was excellent for subscale scores and moderate or good for single items except for the item concerning stool consistency, which was weak. The SRD was found to be 2.8 for the bowel pattern subscale, 4.3 for bowel control subscale, and 3.6 for the quality-of-life subscale. CONCLUSION: The Danish version of the ICIQ-B can be used for Danish patients with PFD, and discriminant validity is good. The structural validity and the internal consistency of the bowel pattern subscale are questionable, indicating that some items do not represent the underlying construct. Test-retest reliability of the ICIQ-B is acceptable, but the change needed to reflect a real change above the measurement error in each subscale is three to four points.

A Preference-Sensitive Online Instrument to Support Shared Decision Making for Patients With Pelvic Organ Prolapse: A Pilot Multicenter Randomized Controlled Trial.

A preference-sensitive instrument for women with pelvic organ prolapse was developed to increase shared decision-making. This study aimed to assess the feasibility of a randomized controlled trial to measure the effectiveness of the instrument. A pilot randomized controlled trial was conducted at three Danish gynecological clinics to assess feasibility through recruitment rates, per-protocol use and women's perception of (1) support for decision-making, (2) shared decision-making (Shared Decision-Making Questionnaire), and (3) satisfaction with their decisions. In addition, a focus group interview with participating gynecologists (five gynecologists) was conducted. We invited 226 women and recruited 46 (20%). The most common reason (45%) for nonparticipation was overlooking the invitation in their online public mailbox. Shared Decision-Making Questionnaire showed high data completeness (96%) but indicated a ceiling effect. Women felt the developed instrument supported their decision-making and more so if it was used interactively during consultations. Despite finding the instrument generally useful, gynecologists tended to apply the instrument inconsistently and not per protocol (41%), and some used it as a template for all consultations. This pilot study indicates that recruitment methods, for a future randomized controlled trial, for example, nurse-led preconsultations, need reconsideration due to low recruitment rates and inefficient per-protocol use. In a future randomized controlled trial, cluster randomization should avoid the carryover effect bias.

Pelvic organ prolapse and treatment decisions- developing an online preference-sensitive tool to support shared decisions.

BACKGROUND: Female patients with pelvic organ prolapse and clinicians need to take decisions regarding treatment that are often unpredictable in relation to how they impact the future everyday lives of the patients. This study formed the developmental phase of a larger study to develop and test an online tool to support shared decision-making. METHODS: Patients, health care professionals and other stakeholders participated in the development and evaluation process of this tool. The collected data was generated from observational studies, exploratory interviews with prompt cards and workshops with end users from four Danish gynecology outpatient clinics. RESULTS: Content analysis led to important themes. For the patients three themes emerged: 1) how the impact of symptoms on everyday life affected the need for relief, 2) their bodily perception and sex life and 3) their worries about the future. For clinicians the different symptoms and their severity was a main theme. CONCLUSIONS: This article provides an overall description and discussion of the development methodology. It demonstrates how user involvement informed the prototyping process and how patients' preferences were included in the final prototype. Whether the tool actually increases SDM, remains to be tested in a pilot feasibility study.

Vaginal pressure during daily activities before and after vaginal repair.

The objective of the study was to measure vaginal pressure during various daily activities in patients before and after vaginal surgery for pelvic organ prolapse, searching data for evidence-based activity guidelines. Vaginal pressure (VP) was studied in 23 patients during activities such as rest, pelvic floor contraction (PFC), coughing, Valsalva, rising from sitting to standing and lifting 2 and 5 kg with four different lifting techniques. VP was measured before, 1-5 days and 4-6 weeks after vaginal repair. Mean VP was four to five times higher during coughing and Valsalva compared to PFC and lifting 2 and 5 kg. Lifting in the walking position created a slightly higher VP compared to other lifting techniques, which did not differ. The VP did not increase when lifting 5 kg compared to 2 kg. Mean VP during coughing and Valsalva were significantly lower 1-5 days after the operation. VP was not related to the type of vaginal repair. The results imply that post-operative counselling should concentrate more on treating chronic cough and constipation than restrictions of moderate physical activities.