Taking part in research studies

Researchers at the University of Birmingham are looking for people with post polio syndrome to volunteer to take part in a research study which aims to improve healthcare services for people with rare neurological conditions (see below for details).

RESULT Study (Review of Epidemiology and Service Use in Rare Long Term Neurological Conditions)

Sonal Shah, University of Birmingham

This study aims to evaluate the services provided for people with rare long term neurological conditions, including post polio syndrome. It is funded by the Department of Health. A few years ago the Department of Health published the National Service Framework for long-term neurological conditions and this highlighted the need for quality standards in providing care and access to services. However, there is little accurate and reliable information about the views of service users and carers on the services currently provided. Without this information it is difficult for the service providers to make improvements. Therefore, the aim of this study is to ask people with post polio syndrome for their views and experiences of health and social care services, and identify good practice as well as any shortcomings or gaps in service provision. We will present this information to policy makers and service providers and feedback to service users and health professionals.

As part of the study we will be asking people with post polio syndrome to complete a questionnaire about your experiences and views of health and social care. The questionnaire will be available from June 2010 and should take approximately 45 minutes to complete. The questionnaire will be available by post, online (http://www.haps.bham.ac.uk/primarycare/ccd/neuro/result.shtml), email, or telephone and is available in a number of languages.

If you are interested in taking part in this study, or to find out more information, please contact Sonal Shah (Address: Primary Care Clinical Sciences, School of Health and Population Sciences, University of Birmingham, Edgbaston B15 2TT Telephone: 0121 414 8585 Email: s.shah.1@bham.ac.uk)

If you would like some support to complete the questionnaire, a carer can help you with it, or you can contact Sonal Shah who will be happy to assist.

Alternatively, if you live within reasonable travelling distance of the University of Birmingham you can opt to have a one-to-one interview at a time and location that is convenient for you.

Research into Post Polio Syndrome (PPS) currently being conducted by Professor C.A. Young at the Walton Centre for Neurology and Neurosurgery in Liverpool (as seen in the January BPF Bulletin)

There has been a marvellous response to the study which the researchers are very pleased about and they would like to thank you all for your interest.

However, a lot of you are asking the same questions so the Fellowship is providing answers to Frequently Asked Questions here, to give you some further guidance.

Please only ring the research assistants if you have questions which are not covered here, and they will ring you back if possible (funding from the BPF is limited and was intended for conducting the study itself).

An open letter from Professor Carolyn Young

Dear All,

We have had a brilliant response to the call for expressions of interest for the post polio fatigue and quality of life research. Many of you seem to think this is an important area to understand better.

The interviews are now all completed and analysis is well underway. It has been fascinating to increase our understanding of the impact of polio. Many thanks to all our many interview participants. We can confirm all the tapes were successfully transcribed to be turned into anonymous typed accounts, and the interview tapes wiped.

Many thanks to the 270 people who expressed interest and returned their proformas and consent forms. 2 of these people sent back consent forms and not proformas, and 3 sent back only a proforma, however we do need both so we will be contacting these people for their missing pages.

We sent out a total of 360 packs, therefore we are still waiting for 90 people to respond. We are unfortunately unable to follow these 90 people up, as we are not funded to do so, and thus have to wait to be contacted. If you still wish to be considered for this research, please do fill in the proforma and both consent forms, and return one consent and the proforma in the reply paid envelope, keeping the information sheet and one consent form for your own records.

Of the 260 people who did respond with the complete information, 206 are eligible to participate in the study. That means that almost 80% of those of you who were interested in the study do appear to be eligible. This is a very high rate of eligibility compared to most studies and means that there was a good match between people who were interested and the criteria for entry.

We are still accepting new participants, please contact us if you would like more information.

We are still very keen to collect names and addresses of people who have no history of polio. They would be asked to fill in a briefer, anonymous questionnaire pack. They would be acting as what is called “normal controls”. In the interviews people said that they thought they had more fatigue and other problems than people the same age who had never had polio. The only way to scientifically check if that is true is to have some data to compare in people without a history of polio. Hence our request for 10-15 minutes or so of work from people without a history of polio.

We hope to be sending questionnaire packs out very shortly. Once again we would like to thank you all for volunteering and enabling us to conduct this research successfully so far. We are hoping that the same level of commitment will be shown for completing the questionnaire research pack.

With best wishes and thanks

Carolyn Young

Frequently Asked Questions

About the study

1) What is the study?

The study title is "Developing fatigue & quality of life scales in neurological conditions". Fatigue is a common symptom in both well and ill people, but appears to be more severe and different in nature in certain chronic disabling neurological conditions, such as Post Polio Syndrome. As the symptom of fatigue is subjective and has been described in a variety of different ways, researchers have struggled to analyse the severity of the problem. Quality of life has been widely studied but recent research work recommends that measures be created which focus on the issues which are important to the person with the condition. The aim of this study is to develop and validate self report questionnaires to measure fatigue and needs-based quality of life in people with Post Polio Syndrome.

2) What do I have to do in order to participate? Will I need to travel anywhere?

The first stage of this study will involve some of you being asked if you would like to be interviewed. These interviews will be done in a private, quiet room or by telephone if you are unable or would prefer not to travel. The interview will be tape recorded and later typed up. These anonymous transcripts will be used to understand your condition better and choose some statements which are good examples of how it feels to live with your condition. A small group of those interviewed may be asked if they would like to meet an investigator of this study, and will trial the draft questionnaire and then have a short face to face interview about it. This will allow any problems with the questionnaire to be identified. It should be noted that due to the marvellous response they have had, the researchers are already in the process of selecting interview participants, therefore it is likely that most of you will now be participating in the questionnaire stage of the study if you decide to proceed.

The questionnaire will be given to a large sample of you to complete, along with some other tried and tested questionnaires looking at fatigue, disability, anxiety/depression and quality of life. This pack of questionnaires requires ticking multiple-choice questions. The questionnaires will take around 20-30 minutes to complete, but you need not complete them in a single sitting. To help the researchers judge the accuracy of the questionnaire in measuring fatigue and quality of life in chronic neurological conditions over time, you may be invited to do a further questionnaire (test-retest) after a suitable time interval, of about 2 weeks. These questionnaire stages involve no travel as they can be posted to you.

It is entirely up to you whether you chose to apply and to help you decide you will have a detailed patient information leaflet to read before signing any consent form.

3) How can the study help people like me who have PPS?

Participation will help direct future research in fatigue and needs-based quality of life from which participants and future patients may potentially benefit.

4) What is the next step if I think I may be interested in participating in the study?

If you may be interested in participating and would like more information about it without any obligation, please send the BPF magazine article slip about this study, which is entitled “Helping people with PPS”, to the researchers, and they will then send an information pack to you. The information pack has more written details about the study in a patient information leaflet, consent forms etc.

5) What criteria do I need to meet in order to be eligible for participating in the study? What if the history of my Polio/PPS is unusual?

When you have considered the study and signed a consent form to take part, you can fill out the short proforma, which is a short tick box screen to check you are eligible to participate in the study. This can be sent by the researcher to you.

6) What if I do not have an official diagnosis of PPS?

Again this will not be a problem provided that you meet the criteria for participation in the study. The proforma will indicate whether you meet these criteria or not.

7) Do I put in my current GP and Consultant details or the ones I had when had acute Polio?

Your current GP and Consultant.

8) Does my GP have to know I am participating in the study?

The ethics committee approving the study design thought it was part of good practice that your GP had a brief letter stating you were taking part in this research.

9) Does it matter if I am unsure of Consultant contact details? Or if I don’t have a Consultant for PPS?

If you do not have a consultant for PPS you can still take part. Please try your best to make any hospital contact details accurate, because the researchers have limited time and funding to make contact with people.

10) If I have numerous Consultants for differing medical conditions, as well as PPS, do I need to put the details of all the Consultants down?

No, you do not need to write down details of all your Consultants for every medical condition. Please put down the most relevant ones that may be related to your post- polio condition e.g. Consultants for respiratory system or muscle weakness.

11) Are there any ways my family and friends can help with research?

Yes, the researchers want to compare fatigue results in people with PPS to people without a history of polio, to check that the fatigue in PPS is not just the same as ordinary fatigue. Therefore they want volunteers of any age to agree to anonymously complete the tick box questionnaire just once, and post it back. If you have family or friends who would do this, email/write to the researchers or write it on your form from the BPF magazine article.

Secondly, your family could help with travel if you want to do a face to face interview, which can be a more satisfactory experience than a telephone interview.

Progress with the research study: Developing and validating self report measures for fatigue and needs-based quality of life in neurological conditions (as seen in the BPF January and March Bulletins) by Professor C. A. Young of the Walton Centre for Neurology and Neurosurgery, Liverpool

Please see the graphs below showing the progress we have made with the above study so far. In summary, to explore issues associated with living with Post Polio Syndrome (PPS), 45 in-depth interviews have been conducted. The goal of these interviews was to find items to be used in the questionnaires we are developing, based on direct quotes from people with PPS. We are now in the process of putting these items together to create two questionnaires, one for fatigue, and one for quality of life.

From the graph below, you can see that our target was to interview 40 participants and we have met and exceeded this target by 5 participants. We have thus finished this phase of the study, and are due to start the next phase shortly.

The below graph shows the number of interview which have been conducted and in which month

In the next phase of the study, we are going to trial the draft questionnaires in a small group of PPS patients to identify any problems with wording or item dysfunction. The final questionnaire will then be posted out to a large sample of people with PPS. We need at least 250 people with PPS to complete and return the questionnaire pack.

As you can see from the below graph, we have not started sending out the questionnaires yet, but we will record the response rate of questionnaires on here. So if you wish to check the study’s progress, please look on this website for our updates.

The below graph will picture the number of completed questionnaires which have been posted back to us, and how far we are to reaching our target number as the month’s pass

We will also need to recruit age and sex matched "normal control" volunteers (people who do not have PPS) to complete the questionnaires so that we can check that fatigue in PPS is not just the same as fatigue from normal ageing. In particular, we are currently seeking these normal controls at present.

If after seeing our current progress, you are interested in participating in this study, it may useful to read the above FAQ’s to help you decide if you want to take part.

If you would like to participate in this study as a PPS patient or normal volunteer, please email the research assistants, EITHER Samantha Wong (samantha.wong@nhs.net) OR Anne-Marie Quincey (anne-marie.quincey@nhs.net) and leave us your email and postal address. Please place in the subject line of your email either "Person who has had Polio" or "Normal Volunteer".

Honorary Research Assistant Contact details

Miss Samantha Wong,
Walton Centre for Neurology and Neurosurgery NHS Trust,
Clinical Trials Unit,
Lower Lane,
Fazakerley,
Liverpool,
L9 7LJ

samantha.wong@nhs.net

Miss Anne-Marie Quincey,
Walton Centre for Neurology and Neurosurgery NHS Trust,
Clinical Trials Unit,
Lower Lane,
Fazakerley,
Liverpool,
L9 7LJ

anne-marie.quincey@nhs.net