Patient Information Leaflet

Study title: Outcomes and patient satisfaction following IGTN surgery at a single practice.

Principal investigator’s name:                                   Chukwudi Ugezu

Principal investigator’s title:                                      Dr

Telephone number of principal investigator:            0876981323

Co-investigator’s name:                                                   Niall Maguire

Co-investigator’s title:                                                Dr

Data Controller’s/Joint Controller’s Identity:`          Dr Seamus McMenanin

Data Controller’s/Joint Controller’s Contact Details: ______________________________

Data Protection Officer’s Identity:                             Dr Joan Gilsenan

Data Protection Officer’s Contact Details:                ______________________________

You are being invited to take part in a research study to be carried out at  Bedford Medical Centre Convent Road Navan by  Chukwudi Ugezu, Niall Maguire

Before you decide whether or not you wish to take part, you should read the information provided below carefully and, if you wish, discuss it with your family, friends or GP (doctor).  Take time to ask questions – don’t feel rushed and don’t feel under pressure to make a quick decision.

You should clearly understand the risks and benefits of taking part in this study so that you can make a decision that is right for you. This process is known as ‘Informed Consent’.

You don’t have to take part in this study. If you decide not to take part it won’t affect your future medical care.

You can change your mind about taking part in the study any time you like.  Even if the study has started, you can still opt out.  You don’t have to give us a reason.  If you do opt out, rest assured it won’t affect the quality of treatment you get in the future.

Why is this study being done?

Surgery for Ingrown Toenail (IGTN)is commonly undertaken in general practice. There are few reports of the success of the operation in this country. At our practice, we are keen to monitor the effectiveness of the surgery that we provide. To this end we propose to ask all patients or parents whose children had the surgery with us in the last 3 years about the result of the operation, any complications of surgery and their satisfaction with service provided. We will use the information gathered to improve our surgical process.

Who is organising and funding this study?

This study is being organised by Dr Ugezu and Dr Maguire and funded by Bedford Medical Centre

Why am I being asked to take part?

You  are being asked to take part in this study because you or your child  underwent ingrown toenail surgery in Bedford Medical Centre in the last 3 years. We want to better understand the sorts of conditions that require surgery for ingrown nails and the success of that surgery as well as any problems that arise. We are also trying to study how satisfied patients/parets of patients are with surgery for ingrown toenail at this clinic.

How will the study be carried out?

The proposed study is a look-back at patients who had t ingrown toenail surgery in Bedford Medical Centre over the last 3 years.

We want to have your permission to look at your medical record and to determine the nature and outcome of the surgery we performed for you or your  child.

We would also like to ask you to complete a short survey about your/your child’s experience of the operation.

What will happen to me if I agree to take part?

We would require you to spend a little time completing the survey you will receive.

What are the benefits?

There are no direct benefits to you in taking part. Your participation may help us improve our service in the future.

What are the risks?

There is a small risk that an unintended leak of your personal information could happen. We plan to take every precaution to safeguard your information.

What if something goes wrong when I’m taking part in this study?

If there was a leak of personal information, we will inform you and report the problem to the Data Protection Commissioner.

Will it cost me anything to take part?

We will ask you to spend a little time on the  survey that you will receive.

Is the study confidential?

The study is confidential and so are all information provided by you will only be known to Dr Ugezu and Dr Maguire.  The results from the study will only be published or shared with other doctors as summary results without details that could identify individual patients.

Data Protection

1. We will use the information you provide to study the results of our surgery for ingrown toenail.

• The research study is undertaken under the law known as the General Data Protection Regulation (2016) Article 9. This law prohibits the use of your personal information except where you consent and it to be used to improve the quality of medical care and when we also apply the strict secrecy that protects your medical record in any case.

• Only Dr Ugezu and Dr Maguire will have access s to your information.

• We will store the information you share with us through our survey in your medical record. It will be kept indefinitely until and unless you are no longer a patient and then it will be kept for at least 7 years in case you need to have it.

• We consider that the only risk of taking part in this study is that the information you share with us and that we access from the record of the toenail operation could be leaked accidentally.

• We want you to know that even if you agree to participate, you can change your mind without this affecting your care by us. If you change your mind, we will remove your information from the study results.

• All patients and study participants can make a complaint about how we are conducting this study to the Data Protection Commissioner. We will facilitate you in making a complaint if you need to.(Please see contact no. at the end of this document)

• All patients can have a copy of all the information in their medical record, including any results relating to this study. (Please see contact no. at the end of this document)

• If you agree to participate but are uncertain about any part of what we do with your information you can tell us what you do and don’t want to allow. (Please see contact no. at the end of this document)

1. If you consider any information we have on record to be incorrect, you have the right to insist that we make corrections. (Please see contact no. at the end of this document)

1. If you wish to have us delete the information you give us or have allowed us to gather from your medical file you just have to tell us. (Please see contact no. at the end of this document)

1. You have the right to ask us to send the information we hold on your care to another clinic or doctor.

1. We will not use the results of our study to create a profile by which we would categorise   our patients.

1. Patients and participants have the right to insist that we do not use the information you provide to make profiles or to allow us to influence your  care.

1. We will not use the information  you share with us for any purpose except the study we have described here.

1. We will not send the information you share with us to any other country and it will only ever  be kept securely in your medical record at this clinic.

Where can I get further information?

If you need any further information now or at any time in the future, please contact:

Name:       Dr Chukwudi Ugezu & Dr Niall Maguire

Address:     Bedford Medical Centre, Athlumney, Navan    

Phone No:  087 9728793 (24/7) 046 9021369 (office hours Mon-Fri)

If you are happy to participate in this research, please complete the short  questionnaire  survey, the link to which we have already sent to you.