Condition category
Digestive System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Faiz Ali


Contact details

Department of Gastroenterology
Neath Port Talbot Hospital
Baglan Way
Port Talbot
SA12 7BX
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title



Study hypothesis

The need to involve patients more actively in decisions about their care is recognised in the NHS Plans for England and Wales. Central to this is the ability to measure a patient's progress from their own perspective. This research will give insight into the feasibility and practicality of measuring and using patient-focused outcomes routinely in outpatients.

In the context of a major, multi-centre trial, MINuET (registered with ISRCTN82765705 -, a simple quality of life measure for use by patients with gastrointestinal disorders, the Gastrointestinal Symptom Rating Questionnaire (GSRQ) has been developed. This is a system-specific questionnaire. It is quick and simple to complete and is applicable to the majority of patients with GI disorders. We hope it will enable the integration of patient-focused measurement into routine clinical practice.

There are three main research questions:
1. In a busy gastroenterology clinic is it feasible for patients routinely to complete electronic questionnaires about their Health-Related Quality of Life (HRQL) - both generic and GastroIntestinal (GI)-specific - and for doctors to use this information? This will be assessed by qualitative interviews of staff and a sub-sample of patients, the proportions of clinic attendees who were eligible and willing to complete electronic questionnaires, and the proportion who successfully completed them among the two groups allocated to do so.
2. Does this intervention improve process of care, notably doctor-patient communication and management decisions? This will be assessed by qualitative interviews, and clinic waiting and consultation times. Limited information on diagnosis and symptoms will be obtained from routine medical records.
3. Does this intervention improve patient outcomes? This will be assessed by a) patient-completed postal questionnaires at baseline, 1 month and 3 months and b) anonymous patient satisfaction questionnaires.

Ethics approval

South West Wales Local Research Ethics Committee, 24/03/2006, ref: 06/WMV02/4

Study design

Single-centre pragmatic randomised controlled trial with repeated measurements

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Gastrointestinal disorders


Electronic Health Related Quality of Life Questionnaire (GSRQ/EQ-VAS) - a combination of Gastrointestinal Symptom Rating Questionnaire and EQ-visual analogue scale. The intervention was carried out whenever patients attended clinic visits during the 3-month study follow-up period rather than at planned timepoints.

Intervention type



Not Applicable

Drug names

Primary outcome measures

The Physical and Mental Component Scores from the 36-item Short Form health survey (SF-36), measured at 3 months.

Secondary outcome measures

1. SF-36 scores at 1 month
2. EuroQol (EQ-5D) quality of life questionnaire, filled at recruitment (baseline), 1 month and 3 months
3. Clinic waiting times
4. Length of consultation, taken from routine patient records
5. Patient satisfaction, measured by the Outpatient Medical Interview Satisfaction Scale (OMISS) after each visit to the clinic

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

All patients attending gastroenterology clinic who are fluent in English and likely to be followed up in the clinic within 3 months.

Participant type


Age group

Not Specified



Target number of participants


Participant exclusion criteria

1. Problem is primarily non-gastrointestinal
2. Currently taking part in an HRQL study
3. Frail or seriously compromised (American Society of Anaesthesiologists [ASA] status 4+)

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Department of Gastroenterology
Port Talbot
SA12 7BX
United Kingdom

Sponsor information


Wales Office of Research and Development for Health and Social Care (UK)

Sponsor details

Welsh Assembly Government
Cathays Park
CF10 3NQ
United Kingdom

Sponsor type




Funder type


Funder name

Wales Office of Research and Development for Health and Social Care - Funding Scheme 2005 (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes