What effect does outcome questionnaire have on biofeedback therapy
Research type
Research Study
Full title
What effect does the choice of outcome questionnaire have on patients’ perceived outcome after biofeedback therapy for faecal incontinence or chronic constipation?
IRAS ID
196414
Contact name
Rhiannon Tompkins
Contact email
Sponsor organisation
Newcastle University
Duration of Study in the UK
0 years, 3 months, 31 days
Research summary
This study will involve the recruitment of a series of subsequent patients attending the GI physiology department for biofeedback therapy. These patients must be over the age of eighteen and will have either chronic constipation or faecal incontinence to be included in this project. A single researcher will carry out this research and will initially assess referrals coming in to the department to check the patient meets these criteria. Referrals to this department for biofeedback therapy are accepted from gastroenterologists, colorectal surgeons, continence nurse specialists and physiotherapists. After identifying potential participants the appropriate patients will be sent a participant information sheet, consent form and two appropriate questionnaires to complete should they wish to take part in the study. They will then be asked to bring all of these completed to their initial biofeedback appointment. Participants will then complete the course of biofeedback therapy as normal within the GI physiology department. Upon discharge the participant will be asked to complete the same two questionnaires again. Patients with faecal incontinence will receive the SF-36 and the FIQL, whereas patients with chronic constipation will receive the PAC-QOL and the SF-36. It is therefore important to identify these two different patient groups in the initial vetting and sorting of referrals.
The two questionnaires used for each patient group will be combined into one booklet for patient ease, however the two questionnaires will be clearly separated and will both ask an extra question regarding patient perceived burden of answering the questionnaire. This question will simply ask the patient to circle on a scale of 1 to 10 the burden or ease of filling out the particular questionnaire. These quality of life questionnaire booklets will all be anonymous and will at no point ask the patient to fill out any personal identifiable information, therefore avoiding any ethical issues.
The data from these questionnaires will be brought together and inputted into a database for statistical analysis using Minitab statistics software, provided by Newcastle University. The pre- and post-questionnaire data will originally be collected in the form of ordinal data but will be converted to numerical data which can therefore be compared using a paired t-test technique. A boxplot of these results can then be produced to allow for easy comparison of the questionnaires.The data collected for evaluating the burden of each questionnaire will be used to find the mean burden for each questionnaire, and this data can also be analysed using a paired t-test.
REC name
East of England - Essex Research Ethics Committee
REC reference
15/EE/0472
Date of REC Opinion
11 Dec 2015
REC opinion
Favourable Opinion