Management for Adults with Chronic RhinOsinusitis – the MACRO Programme:

A patient interview study.

Chief Investigators: Mr Carl Philpott & Ms Claire Hopkins

Information Sheet

What is the purpose of this research?

Many people in the United Kingdom (UK) experience symptoms of Chronic Rhinosinusitis (CRS). The symptoms include a blocked and runny nose, loss of smell, facial pain, tiredness and breathing problems. These symptoms can impact greatly on quality of life. When people with these symptoms of CRS go to their general practitioner (GP) for medical advice they may receive a variety of different treatments such as saline or steroid nasal drops or sprays and drugs including antibiotics. However,national guidelineswhich were developed for GPs and hospital doctors to guide them on how to treat patients with CRS do not encourage them to prescribe antibiotics, because there is uncertainty about their benefits and there is a risk of side effects and antibiotic resistance. Many of these patients will at some stage be referred to an Ear, Nose and Throat (ENT) specialist and attend a hospital appointment, where they may then undergo furthermedical treatment or sinus surgery, even though the role of surgery in treating CRS is still unclear.

This interview study is part of a larger programme of research which seeks to establish the best treatment for doctors to recommend for sinusitis patients. Our team includes GPs, experts in sinus disease and breathing disorders, research experts and patient representatives, from across the UK. The research will be conducted by the University of Southampton and sponsored by University College London. This research is funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research and has been approved by the Health Research Authority (reference number: 208301).

The aim of this study is to conduct telephone interviews with adult patients with CRS to help us better understandpatients’ views and experiences of living with and managing their CRS. We would also like to know your views on two flow diagrams (A &B) representing two possible ways of comparing treatments for CRS (clinical trial designs¹). This is so we know if patients (like yourselves) have a preference for a particularclinical trial design(flow diagram A or B). The information gained from this patient interview study will shape the next stage of the programme of research where we choose the final clinical trial design (A or B).

Why have I been chosen?

You have been invited to take part in an interview because you have seeneither your GP or a hospital doctorduring the past 12 weeksto discuss your symptoms of CRS.

What does the telephone interview involve?

  • The telephone interview will take approximately 30 to 45 minutes (including a break if necessary).
  • In preparation for the interview, please read this patient information sheet and flow diagrams A and B, which show two differentclinical trial designs.

¹ To find out more about clinical trials, visit:

  • At the beginning of the telephone interview the researcher will ask you whether you have read this information sheet and the flow diagrams A and B and if you have any questions. They will then ask you whether you are happy to consent to the interview taking place by asking you a series of questions, such as whetheryou are happy for the interview to be recordedusing an audio voice recorder. Once the researcher has received your verbal consent to the interview taking place, the main part of the interview will begin.
  • During the interview the researcher will ask some questions and you will have the opportunity to share your experiences of living with and managing your CRS. The researcher will also ask you for your views on flow diagrams A and B, and any reasons for your choice.
  • The recorded interview will then be transcribed so that it can then be analysed by the researcher.

Explanation of flow diagrams A and B (attached)

In flow diagram A one stage randomisation*,all patients first receive a 6-week trial of nasal steroid spray. All patients with CRS symptoms that have not improved enter the trial where they are randomised* to one of three possible treatment groups; those receiving a daily low dose antibiotic tablet for 12 weeks,or a placebo tabletfor 12 weeks ,or those undergoing endoscopic sinus surgery and post-operative medical treatment. All groups are followed up for a period of 9 months after entering the trial.

In flow diagram Btwo stage randomisation*,all patients first receive a 6-week trial of nasal steroid spray.All patients with CRS symptoms that have not improved enter the trial where they are randomised* to one of two possible treatment groups; those receiving a daily low dose antibiotic tablet for 12 weeks, or a placebo tablet for 12 weeks. All patients with CRS symptoms that have not improved are then randomised again to either receive ongoing medical treatment (nasal steroid sprayand saline rinse, with an initial course oforal steroids and nasal steroid drops) or undergo endoscopic sinus surgery and post-operative medical treatment. All groups are followed up for a period of 9 months after entering the trial.

During the interview, we will ask you some questions about your views on the trial designs and the reason for your preferred choice.

What are the advantages of taking part?

The information we gain from conducting this study will shape the research on CRS and how patients with CRS are treated in the future. The results of this study will feed in to a larger programme of research which seeks to establish the best treatment for adults with CRS that doctors should recommend.

What are the disadvantages of taking part?

We do not anticipate any disadvantages or risk as a result of participating in this study, only the possible inconvenience of taking part in a telephone interview. Some people may feel uncomfortable discussing their past experiences of living with and being treated for CRS. If you do become upset during the interview, you can stop at any time. If you have any concerns or questions, we encourage you to speak with the study team.

Expenses and payments

If you agree to take part in the telephone interview you will receive a £50.00 voucherto thank you for the time you have given for the interview (approximately 30 to 45 minutes in total). The research team will arrange to send you the voucher in the post after the interview has taken place.

Will my taking part in this study be kept confidential?

All information that you provide during the interview will be kept strictly confidential. Your name and any identifiable patient information will not be used in any publications or reports. Only the study team will have access to your contact details. Any personal data, such as contact details, will be stored for a maximum of 3-6 months after the study has ended, and then all personal data will be destroyed. Information from all interviews will be analysed and used for this study, as well as for teaching and educational purposesprovided you have given us consent for this. Anystudy information will be kept in secure locked filing cabinets in locked rooms, and stored on password protected computers on a secure server within the University of Southampton. .

What happens if I change my mind?

Taking part in this interview study is voluntary. It is up to you to decide whether to take part. You can decide not to continue at any time without giving a reason. If you decide not to take part in the study, this will not affect the standard of care you receive from your doctor for your CRS.

What happens if something goes wrong?

This study is based on taking part in one telephone interview thereforewe do not anticipate any harm caused to you as a result of taking part.

Who has reviewed this study?

All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee, to protect your interests. This study has been reviewed and given a favourable opinion by <insert name of> Research Ethics Committee.

What will happen to the results of this interview study?

The results will be published in scientific journals,communicated at professional and patient meetingsand conferences and used for the NIHR website. A summary will also be posted on patient and charity websites. A summary of the findings will be sent to all participants who would like to see the results and the full report can be made available on request and will be made available through the patient charity website of Fifth Sense ( ).

Patient and Public Involvement in this study

Patients and members of the public have been key to the development of all the MACRO programme of research, ensuring it reflects patients' needs and priorities. They have also been actively involved in setting up this interview study and have reviewed lay summaries, patient information sheets, clinical trial design flow charts and interview questions. Patients and members of the public will also be invited to comment and feedback on the analysis of the interview data and will be involved in the dissemination of findings through presentations to patient groups and will act as authors on journal articles.

What next?

If you have any further questions, please do not hesitate to get in touch with <insert name of research fellow> or, Caroline Eylesusing the contact details below.

Name / Name of Research Fellow / Caroline Eyles
Role / Qualitative Researcher
Research Fellow to be appointed / Lead Qualitative Researcher
(Senior Research Fellow)
Address / University of Southampton
Primary Care & Population Sciences
Aldermoor Health Centre
Aldermoor Close
Southampton, SO16 5ST / University of Southampton
Primary Care & Population Sciences
Aldermoor Health Centre
Aldermoor Close
Southampton, SO16 5ST
Telephone / Insert telephone number / 02380 241089
Email / Insert email address /

If you are interested in taking part, please complete the reply slip attached to the invitation letter and symptom severity score form and return them to the study team in the FREEPOST envelope provided, or discuss with the nurse at your location. The symptom severity score form will assist the study team in ensuring that patients with a varietyof symptom severities are recruited onto the study. Alternatively, you can email the team on this address, <insert email address> or call the following number <insert phone number>. A member of our study team, <insert name of research fellow>, at the University of Southampton, will then contact you to discuss further details of the study with you and will ask you some questions, to ensure that you meet all of the study conditions.

If you cannot, or do not wish to, take part in the study it would also be helpful for usif you could fill in the reply slip and return it in the FREEPOST envelope. This will help us to understand your reasons and will ensure that our study findings are accurate.

What if there is a problem?

If during the course of the interview you disclose any information that indicates that there have been instances of poor practice in relation to a medical practitioner or to treatment that you have received, then the disclosure will be discussed within the research team and appropriate action will be taken from there.

If you had any concerns about any aspect of the study, you can speak to a member of the research team, Caroline Eyles or <insert name of research fellow to be appointed>. Their contact information is provided in the table above.They will liaise with the Chief Investigators, Carl Philpott and Claire Hopkins and will aim to resolve the problem in the first instance. In the unlikely event that you are harmed by taking part in this study, or if you remain unhappy and wish to complain formally, you can do this through the NHS Complaints Procedure. Details can be obtained from the hospital Patient Advice and Liaison Service, PALS (

THANK YOU FOR TAKING THE TIME TO READ THIS INFORMATION

Glossary of terms:

Antibiotic resistance:is when an antibiotic drug has lost its ability to control or kill bacteria.

Chronic: is when an illness persists for a long time or is constantly recurring.

Chronic rhinosinusitis:inflammation or infection of the nose and sinuses, lasting 3 months or more, which can cause a blocked and runny nose, loss of smell, facial pain, tiredness and breathing problems.

Clinical trial:a clinical trial compares the effects of one treatment with another.It may involve patients, healthy people, or both.Read more:

Randomised/Randomisation: When a person joins a clinical trials they are often divided into different groups. To make sure that each group contains a similar mix of people, many trials are ‘randomised’. This means that people are allocated at random (by chance) to one of the groups in the trial, often by using a computer programme. When people are randomised they have an equal chance of being in either trial group.
Read more:

PIS Patient MACRO qual; v32.0; 2194/1009/16; Page 1 of 5; IRAS ref: 208301