The Chinese University of Hong Kong
Faculty of Medicine
Department of Medicine & Therapeutics

Patient Information Sheet

You are being invited to take part in a research study. Before you decide it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with others if you wish. Ask us if there is anything that is not clear or if you would like more information. Take time to decide whether or not you wish to take part. Thank you for reading this.

Title
The Nixon-TAM Hong Kong IBD Registry

Background
Crohn’s disease and ulcerative colitis are inflammatory disorders of the gut which cause major life-long disability. They affect males and females, with the commonest age of onset in childhood, teens and early adult life. Previously restricted almost exclusively to the West, these conditions are becoming much more common in Asian countries, including Hong Kong – the cause of this dramatic change is unknown.

The cause of IBD is widely accepted as relating to the mucosal immune response to stimulation from the gut bacteria, on a background of genetic susceptibility. The bacteria and other organisms in the gut play a central role in the development of IBD in the West. However it is unknown if the gut bacteria differ between Chinese patients with IBD and non-IBD (healthy subjects) in Hong Kong, and whether it is affected by diet or changes in diet. A family history is the largest risk factor for the disease. More than 50 different genes associated with IBD have recently been identified in the West and preliminary data showed that Chinese patients have a different genetic profile to Western populations.

This project aims to investigate the prevalence, demographic factors, and disease outcome of IBD patients in Hong Kong. The previously low incidence of IBD in Hong Kong may have been underestimated due to limited data availability and centralisation, limited investigations and lack of epidemiological studies. To create a database registry to capture information.

Purpose
The aim of this study is to investigate the prevalence, demographic factors and disease outcome of IBD patients in Hong Kong.

Do I have to take part?
It is up to you to decide whether or not to take part. If you do decide to take part you will be given this information sheet to keep and be asked to sign a consent form. If you decide to take part, you are still free to withdraw at any time and without giving a reason. A decision to withdraw at any time, or a decision not to take part, will not affect the standard of care you receive.

Why have I been chosen?
You have been invited to take part because you have been diagnosed with IBD.

Why should I, and how do I participate in this study?
Your participation is valuable and important to us, because IBD is a chronic inflammatory condition with yet a cure, and it is rapidly increasing in Hong Kong. By collecting and analyzing information from patients who suffer from IBD, we hope to understand the true impact of disease on the patients’ health and the burden on society, as well as identify factors that can improve the outcomes in this disease.

You will be collected your personal data focused on age, gender, date of birth, family history of IBD, the resection history since last visit, , Cancer diagnosed since last visit, Mortality, disease characteristics, laboratory result of blood and medical therapy since last visit through Hospital Authority Patient Record System retrospectively. Data evaluated including patient’s change of disease status since last visit, disease activity since last visit, maximal therapy since last visit,Harvey-Bradshaw Index (HBI) or Simple Clinical Colitis Activity Index (SCCAI), Quality of life in Inflammatory Bowel Disease Questionnaire (IBDQ) and Asian Environmental Questionnaire will be collected prospectively at ward or clinic visit..At the same time, one stool sample will be collected for microbiology tests, and 2 bottles of 3 ml of blood will be stored for genetic analysis in the future. Patients who do not wish for serum DNA to be stored will still be eligible to participate in the main epidemiology study. Genetic results will not be made available to individual subjects in a future date as there is no evidence to support genetic testing for risk prediction in routine practice, but these large scale genetic results will be useful to identify relevant future therapeutic targets for the treatment of IBD. They will also help with the possible discovery in the future of genes that cause IBD. You will be followed up about the change of disease characteristics; adverse effects from drugs; surgery; cancer or mortality for five years. Samples will be processed and tested in Hong Kong. The study is expected to be completed by 2018.

What are the potential risks and discomforts?
There may be some discomfort or minor bruising from blood taking. Fainting is an occasional adverse event related to blood taking. There is a slight possibility of infection of the skin or vein.

Alternatives
You may choose not to participate in this study.

Subject Cost and Payment
There is no additional cost or payment for your participation in this study.

Confidentiality
Your data will be kept strictly confidential and will only be assessed by a designated adjudication committee. All data will be stored in a database with limited access for 15 years.

Patient Rights
Your data will be kept strictly confidential and will only be assessed by a designated adjudication committee. You can contact our investigators Prof Siew Chien Ng/ Miss Tiffany Chung Mei-Lan / Ms Jessica Ching Yuet-Ling (Tel 2632 1519 / 2632 3855) for questions related to the present study. You can also dial the hotline of Joint The Chinese University of Hong Kong –New Territories East Cluster Clinical Research Ethics Committee at 2632 3935 for patient right-related questions. You are assured that refusal or early discontinuation of participation in the study will not result in any loss of benefits or penalty to a patient’s care.