PAF-study: results on quality of life 175 7 social functioning, role limitation due to emotional problems, mental health, and health change perception. The RAND-36 consist of the same sets of items as the SF36,20 although the scoring procedure differs between the RAND-36 and SF-36 on the domains of general health and bodily pain. The score for each scale is obtained by the sum of the scores for each item linearly transformed into a range from 0 to 100. Higher score indicates more favorable QoL. To quantify the average intensity of pain during defecation, a visual analog scale (VAS) from 0 (no pain) to 10 (most intense pain) was used.21 Patients were requested to fill in the RAND-36 and VAS-score at baseline, and at 8- and 20-week follow-up. Interventions At baseline, patients in both groups received information about the pelvic floor and related symptoms, explanation about relevant anatomy and defecation (patho) physiology, behavioural modifications, and lifestyle advice. All patients continued their conservative measures including the use of ointment (diltiazem or isosorbide di-nitrate). PFPT consisted of 5 face-to-face appointments of 45-minutes in a period of 8 consecutive weeks, using a treatment protocol. Details of this treatment protocol were prescribed earlier.14 Patients who were assigned to postponed PFPT did not receive additional treatment besides their conservative measures and the use of ointment until first follow-up at 8 weeks after inclusion. Patients from the postponed PFPT group followed the same treatment protocol after first follow-up. Data collection of the RAND-36 was facilitated by a secure on-line system called Castor EDC.22 Patients received the questionnaire by e-mail through the Castor system at 3 timepoints; at baseline, at 8- and 20-week follow-up. Outcome measures The primary outcome of this study was QoL in patients with CAF and pelvic floor dysfunction before and after PFPT and compared to reference values of the general Dutch population. The other outcome measure was the average pain intensity during defecation on a VAS-scale. The sample size of the PAF-study was based on the primary endpoint, the tone at rest during electromyographic registration of the pelvic floor and consisted of 140 patients.14 The data from the questionnaires that were at least 75% completed at baseline and follow-up were used for the analysis of this study.
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