Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
IBS-symptom severity scale |
The score of this system is based on five items (severity and duration of pain, abdominal distension, bowel satisfaction, and interference with life in general) and uses visual analogue scales. Patients can be categorized as having mild (75-175), moderate (175-300), or severe (>300) IBS. |
Change to baseline at 3rd Month |
|
Secondary |
IBS Rome III |
IBS symptoms will be recorded using Rome III Modular Questionnaire |
Baseline |
|
Secondary |
IBS quality of Life III |
The IBS-Qol is a 34-item measure of the degree to which IBS symptoms affect lives (5-point scale) The individual responses to the 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life. There are also eight subscale scores for the IBS-QOL (Dysphoria, Interference with Activity, Body Image, Health Worry, Food Avoidance, Social Reaction, Sexual, Relationships). |
Baseline & 3rd Month |
|
Secondary |
IBS pain scale-Pain Vigilance and Awareness Questionnaire |
This 16-item measure will be used to assess pain awareness on a 0-5 point scale, tapping into constructs of awareness, vigilance, preoccupation, and observation of pain. Participants will rate a number of statements from 0 (Never) to 5 (Always) such as; I keep track of my pain level. |
Baseline & 3rd Month |
|
Secondary |
Brief Disability Questionnaire (BDQ) |
Disability will be assessed using the cross-culturally validated BDQ, which includes 6 items from the SF-36, asking subjects whether they had been limited in various everyday activities during the last month and four ques-tions concerning daily functioning. Total scores across items 1-6 are considered to indicate 'moderate' and 'severe' disability for score ranges 8-13 and 14-22 respectively. Additionally, participants were asked to estimate how many days over the prior few weeks they were unable to carry out their usual daily activities thus providing an estimate of 'functional disability'. |
Baseline & 3rd Month |
|
Secondary |
Client Satisfaction Questionnaire |
CSQ is an 8-item scale that shall be used to measure satisfaction with the treatment received. CSQ is an 8-item scale that shall be used to measure satisfaction with the treatment received.This scale is scored by summing the individual item scores to produce a range of 8 to 32, with high scores indicating greater satisfaction |
3rd month |
|
Secondary |
Global Improvement Scale (GIS) |
Global Improvement will be assessed with the Global Improvement Scale (GIS).This scale asks participants "Compared to the way you felt before you entered the study, have your IBS symptoms over the past 7 days been from (1) = substantially worse, to (7) = substantially improved. Global improvement is noted for patients endorsing moderately or substantially improved status. |
3rd month |
|
Secondary |
EQ-5D (EuroQol-5 Dimensions) |
It is a generic measure in which health status is defined in terms of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.Each dimension has three qualifying levels of response roughly corresponding to 'no problems', 'some difficulties/problems', and 'extreme difficulties. The scale has been already used in Pakistan. |
Baseline and 3rd month |
|
Secondary |
Mini International neuropsychiatric Interview (MINI) |
Mini International neuropsychiatric Interview (MINI) will be used as a psychiatric diagnostic instrument. It is a short structured diagnostic interview, for DSM-IV and ICD- 10 psychiatric disorders. With an administration time of approximately 15 minutes, it was designed to meet the need for a short but accurate structured psychiatric interview for multicenter clinical trials and epidemiology studies and to be used as a first step in outcome tracking in non research clinical settings. |
Baseline |
|
Secondary |
Hospital Anxiety and Depression Scale (HADS) |
The Hospital Anxiety and Depression Scale (HADS) shall be used to assess anxiety and depression. Score 0-7 is considered as (NORMAL) 8 to 10 (Borderline Normal) 11-14 (Moderate), 15 to 21 (Severe) for sub scale separately |
Baseline and 3rd month |
|
Secondary |
The Illness Perception Questionnaire (IPQ) |
The IPQ will be used to assess the cognitive representations of illness. The Identity scale is comprised of 12 core symptom items that the patient is asked to rate for frequency on a four point scale ranging from "all of the time" to "never". There are total 26 items in rest of the 4 scales and are rated by the patient on a five point scale ranging from "Strongly Disagree" to "Strongly Agree" (scored 1 to 5) |
Baseline |
|
Secondary |
Short Explanatory Model Interview |
SEMI is a short interview that will be administered to elicit the explanatory models.The interview explores the participants' cultural background, nature of presenting problem, help seeking behaviours, interaction with physician and beliefs related to illness. |
Baseline |
|