OKIS progress update

The aim of this blogsite was to provide us (the research team) with a way of engaging with people who might be interested in our research project from the start. It will also play a major role in helping us disseminate the final results: but we have a bit to go yet.

The main ‘output’ of our work will be an NIHR HTA report. This report contains details of everything we have done, including the methods, the results and our conclusions from the systematic review, the patient interviews and the survey of health professionals.  We then take an overall view of the results and interpret what we have found in a concluding discussion section and consider what the implications might be for clinical practice and for further research.

The report than has a considerable journey of its own: the draft we have just finished has gone out to our Advisory group members for their comments and suggestions. We then address any issues they raise, before submitting the report to our funders, NIHR HTA programme. They have a team of editors who check the report and send it out to some external, independent experts for peer review. This means every aspect of the report will be examined to ensure that we have done everything we agreed to do when granted the funding, that we presented our methods and results clearly and precisely, and that our discussion and implications sections are appropriate and supported by the work we have done.  The comments of the peer reviewers will be sent to us and addressed before the report is finally returned to NIHR HTA programme to be published in the NIHR Journals Library.

While the report is out for peer review, we will be working on other dissemination outputs. This includes drafting a summary report, a number of blog posts and some academic journal papers. Once the peer comments have been addressed and any necessary changes also made to these other outputs, we will be able to make the findings available. All these other formats will aim to present the essence of the full report in brief and in lay language so everyone understands the findings and implications.

Thanks for your patience, be assured that we will make sure you get to know the findings as soon as possible – just watch this space!

How can we know what works?

The news is full of stories the amount of health information available on the internet. The availability of this wealth of information has led to an increase in informed patients being able to have detailed discussions with their doctors. The emphasis has to be on discussions because: not all information on the internet is accurate or based on sound scientific proof; not all patients can distinguish the good from the harmful; and neither can all involved in providing health care. We are all human and therefore fallible.

If you want to know how we mislead ourselves, and how we can be misled by the internet, researchers, and doctors try reading Testing Treatments. The book and interactive site, “urges everyone to get involved in improving current research and future treatment, and outlines practical steps that patients and health professionals can take together to do this.” 

A little bit about the NIHR and our funding

The National Institute for Health Research (NIHR) was set up in 2006 to rationalise and improve the efficiency of funding and commissioning of health research. The NIHR’s mission is,

 “To provide a health research system in which the NHS supports outstanding individuals working in world-class facilities, conducting leading-edge research focused on the needs of patients and the public.”

The NIHR manages its health research activities by providing: the infrastructure, made up of clinical research facilities, centres and units and communication networks; support for the individuals carrying out and participating in research through the faculty; programmes to commission and fund research; and by providing unified systems for managing research and its outputs.

NIHR research programmes evaluate the effectiveness and impact of new healthcare treatments, find new ways of preventing, identifying and treating ill health. This includes facilitating timely progress of research in the laboratory through to clinical trials; commissioning research into the way services are delivered, and interventions intended to improve the health of the public and reduce inequalities in health. This evidence is than made widely available to ensure that decisions about health and social care are being informed by the best possible evidence. The NIHR journals library includes reports on all NIHR funded research.

The OKIS project is being funded through the Health Technology Assessment (HTA) Programme: the largest of the programmes, it funds independent research about the effectiveness, costs and broader impact of healthcare treatments and tests for use in the NHS. The HTA programme identified the need for research into the effectiveness of orthotic devices for knee instability in people with MND or CNS disorders and put out a call for those interested to say how they would go about answering the research question. All the applications were peer reviewed before the funding was awarded. Our intention to create this blog was favourably commented on by the peer reviewers!

The NIHR is a large and complex organisation. The recently launched new website provides information about the NIHR, what it has already achieved and what the future holds. So find out more about the work of the NIHR and how research is funded and commission, you can go to http://www.nihr.ac.uk/

Bloggger: Alison Booth

Ethical principles: Protecting researchers

Ethics approval for a study to proceed is also concerned with safeguarding researchers. At its most basic, this relates to personal safety, especially if the researcher is conducting research in an unfamiliar setting. Researchers may feel exposed to the possibility of physical threats, or they may experience psychological upset or trauma at what they are told, or feel anxious that they could find themselves in a potentially compromising situation.

Common ways of minimizing potential risks to researchers include training in interpersonal skills; use of established procedures to let staff know their whereabouts and to maintain contact; and the use of ‘debriefing’ if researchers are talking to people about particularly sensitive or emotional subjects.

During the OKIS study, the researchers will use a ‘check in, check out’ system to promote personal safety.

This is the last in the short series of blogs on research ethics principles but I'm sure we'll be touching on aspects in future blogs about progress with different aspects of our project.

Blogger: Dorothy McCaughan

Ethical principles: Ethics of interviews

The place where an interview takes place is important. Many people feel more comfortable being interviewed in their own home environment, though others may prefer a clinic or university room. In the OKIS study, we will ask individual patients where they would like the interview to take place, and the researcher will turn up promptly for the appointment. Interviews will last only as long as the participant wishes, and they may stop the interview at any time.

When interviewing is carried out with regard to the interviewee’s agenda, with empathy and understanding, it can be a very positive experience for study participants. Many people are pleased that someone is taking an interest in their lives and concerns. Good research interviewers try to ‘connect’ with participants, and encourage them to tell personal and detailed stories about themselves. For this to be done ethically, it must be done with respect for the interviewee as an individual.

Providing a summary of study findings to study participants is an important ethical aspect of the research process. In the OKIS study, everyone who gives of their time to take part in an interview will receive a summary of the overall research findings once the study is complete.

Blogger: Dorothy McCaughan

Ethical principles: Confidentiality

The Declaration of Helsinki states that ‘Every precaution should be taken to respect the privacy of the subject and the confidentiality of the patient’s information’ (WMA 2000). Confidentiality is a key issue in research practice. For example, information gained from research must not be disclosed in other settings, such as through informal conversation.

In the OKIS interview study, we will audio-record interviews with patients and then the recording will be typed up or ‘transcribed’. The written accounts of interviews (transcriptions) do not contain any patient identifiers – names of people and places are removed when the audiotape is being transcribed. Each transcription is given a patient identifier, a code number, which means it cannot be linked to a person. Only the main study researchers have the ‘key’ to link the name of individual patients with the identification (ID) code. This helps protect confidentiality of patient data. Information from interviews is stored on the University of York’s password protected computer server and/or in locked filing cabinets in a locked room, in an area accessible only to university members of staff.

Confidentiality also relates to published accounts of the research, in which the identity of the research sites (where the research takes place) and individuals involved should be protected where possible. Names and other identifiers can be changed to protect the privacy of participants. For example, in a published paper, the researchers may refer to ‘‘hospital A’ and ‘hospital B’, situated in a large urban area in the North of England’.

Blogger: Dorothy McCaughan

Is everyone able to give informed consent to take part in a research study?

This is an interesting question which raises a number of issues. For consent to be considered both legal and ethical, it must be: given by a person with capacity; voluntarily given, with no undue influence; given by someone who has been adequately informed; and a fair choice.

What is capacity?

Capacity refers to the everyday ability that individuals possess to make decisions or to take actions that affect them, from simple decisions such as what to have for breakfast to far-reaching decisions about serious medical treatment or financial affairs. A person lacks capacity if he or she is unable to make or communicate a decision about a particular matter because of an impairment of, or a disturbance in, the mind or the brain. This may be the result of a variety of conditions, including dementia, mental illness, learning disability, brain damage, intoxication or any other condition causing confusion, drowsiness or loss of consciousness (e.g. concussion, stroke, heart attack, epileptic fit, serious accident, delirium).

Vulnerable groups

Some groups of people are regarded as ‘vulnerable’ in terms of giving informed consent to take part in research studies. Children (under 16 years of age), people with learning and difficulties and others who may lack capacity to give informed consent (such as people with dementia or enduring and severe mental health problems, or those who are unconscious) fall into this category. The interests of these groups of people are protected in a variety of ways, including by acts of legislation, an important one being The Mental Capacity Act (2005).

Lack of capacity to give consent

The Mental Capacity Act (2005) provides a comprehensive framework for decision making on behalf of adults aged 16 and over who are unable to make decisions for themselves, i.e. they lack capacity. The Act applies to all decisions taken on behalf of people who permanently or temporarily lack capacity to make such decisions themselves, including decisions to include such people in research. All researchers working with research participants who lack, or may lack, capacity need to be aware of its underlying principles and the provisions relating to research. The Act is accompanied by a statutory Code of Practice providing guidance on how it should be used. Researchers and others making decisions involving people lacking capacity have a legal duty to have regard to the guidance in the Code of Practice. The Act applies in England and Wales only.

Children and young people

There are many ethical and legal issues to consider when involving children and young people in research, depending on the type of study being carried out (for example, whether or not it is a clinical trial of a medicinal product (CTIMP), and whereabouts in the UK the study is taking place. In particular, it is important to understand the key concepts of consent and assent.

Consent is a legally defined decision given by someone who is competent, who has been adequately informed (and has adequate understanding), and who is free from undue influence enabling them to make a voluntary decision. The person can provide consent, provided they are competent. Otherwise someone who is empowered by law can provide it (e.g. a parent in the case of children). A child who is not capable of giving consent alone can still be involved in the decision making process with others who are able in law to provide consent. There is no legislative statute in England, Wales or Northern Ireland governing a child’s right to consent to take part in studies other than CTIMPs. Common law presumes that young people aged between 16 and 18 years old are usually competent to give consent to treatment.

Assent is difficult to define and is used in diverse ways e.g. compliance by a child as young as three years old, to active agreement of a young teenager. Assent is agreement given by a child/young person or others who are not legally empowered to give consent. It is important to provide children/young people with information that matches their capacity when seeking assent.

Gillick competence

Case law suggests that if a young person has sufficient understanding and intelligence to fully understand what is proposed, and can use and weigh this information in reaching a decision, they are considered ‘Gillick competent’ and can give consent to treatment. ‘Gillick competence’ is a term originating in medical law to decide whether a child (16 years or younger) is able to consent to his or her own medical treatment, without the need for parental permission or knowledge. The standard is based on a decision of the House of Lords in the case Gillick versus West Norfolk and Wisbech Area Health Authority (1985). The case is binding in England and Wales, and has been approved in Australia, Canada and New Zealand. When a young person is believed to be competent, consent from those with parental responsibility is not legally necessary, although the involvement of parents in decision making is encouraged in most circumstances.

In the absence of law relating specifically to research, it is commonly assumed that the principle of ‘Gillick competence’ can be applied not only to consent for treatment but also to consent for research.

As you can see from the above, researchers hoping to gain consent from individuals to take part in a study must give careful consideration to a range of sometimes complex ethical and legal issues.

Blogger: Dorothy McCaughan

Ethical principles: Informed consent

This is the first in a short series of blog posts that briefly looks at each of the key ethical principles it has been important to consider for the OKIS interview study.

Informed consent is the principle that individuals should not be coerced or persuaded, or induced, into research ‘against their will’, but that their participation should be voluntary, and based on a full understanding of the implications of participation. This is especially important if the research involves certain groups of people regarded as ‘vulnerable’ in this respect, such as children, or people with learning difficulties.

Informed consent means that patients should be given sufficient information about a study, and time to consider and decide whether or not they wish to take part.  Information about the study may be given to patients verbally as well as in writing.  In many cases, patients are initially informed about research studies by the health care professionals looking after them.

In the OKIS study, patients aged 16 years and over, who have been fitted with an orthotic device (such as a brace or calliper), will be told about the research by their healthcare professional, who will also give them the written participant information sheet.  If someone is interested in hearing more about the study, the healthcare professional will ask for their permission to pass on their telephone number to me as the researcher and I will contact them in a few days’ time to answer any questions. If the patient decides that they would like to take part in the study, a mutually convenient time and place will be arranged for an interview to take place.  If the participant wishes, a family member or carer may be present during the interview.     

Before the start of the interview, I will ask the participant to sign a written consent form which has been prepared specifically for this study. By signing the consent form, the participant is agreeing to take part in an interview and for it to be recorded.  They are also agreeing that quotations from their interview may be used in reporting the study findings. However, everything said during an interview will be made anonymous, so that individual participants cannot be identified. The consent form makes it clear that the participant can leave the study at any time, and that this will not affect their medical management in any way.

Blogger: Dorothy McCaughan

Keeping things in perspective

As researchers we spend a great deal of time initially reading around a topic and examining the published research evidence. In order to be answerable, research questions are usually very specific, as in this project where we are focussed on orthotic devices for knee instability in people who have a neuromuscular disease or central nervous system disorder. So when we get the opportunity to meet and talk with people our research is aimed at helping whenever possible we take it!

Such an opportunity was taken when we attended a really interesting meeting of the Yorkshire and Humber Muscle Group in York last Friday. When we got in touch with the group to circulate our advert for patient members to join our Steering Group they invited us along to the meeting. As well as having an opportunity to tell the group about our research we heard about the work that the group is doing in the Yorkshire and Humber region. This included reports from those providing support to people with neuromuscular conditions in the region, fund raising successes and possibilities, and advice on new self-managed funding arrangements. The meeting was hosted by the Muscular Dystrophy Campaign, who provide details about this group and similar ones all over the country on their website.

Some of the discussions at the meeting were a very strong reminder for us that in the context of complex neuromuscular conditions walking problems can be just one of many challenges people are dealing with. We are aware that our research is asking very focused and specific questions but the meeting has made us very mindful of the wider context in which our research question fits. This will be reflected in the discussion section of our final report.

Bloggers: Catriona McDaid and Alison Booth

And we've started!

It was great to get the project started - on the auspicious day of 1st April(!). Although it is the beginning it has felt like quite a journey getting here. The project was commissioned by the NIHR HTA programme back in Spring 2013 when they advertised an outline of the question they wanted addressed and invited proposals from researchers. But the HTA will have started exploring it as a possible topic for commissioning research on well before then. If you are interested in how HTA prioritises topics for research you can find out more information by following the links on the HTA Programme website.  Members of the public, health care professionals and policy makers can make suggestions to NIHR about any ideas they would like them to consider for funding. You can find details of how they identify research questions and access the on line suggestion form at http://www.nets.nihr.ac.uk/identifying-research.

The overall questions to be addressed by this research project are: what orthotic devices are currently in use in the NHS for knee instability for people with neuromuscular conditions, what are the costs involved and what further research is needed. An important aspect of our work is to find out what the most important issues are for patients. Our research project is intended as preparatory work to inform a different piece of research sometime in the future which will look at the clinical and cost-effectiveness of different types of orthotic management of the knee in people with neuromuscular disease.

We are starting with the systematic review of previous evidence. However we have also started planning the qualitative study of the views of orthotic users as we will need to apply for research ethics approval before we can start recruiting people to take part. We have also started planning exactly what we need to ask healthcare professionals delivering orthotic services and how we can make sure we get a good response rate to the survey. So please feel free to tell anyone relevant about this blog and our research project and help us build up a network.

Blogger: Catriona McDaid

Getting the perspective of patients

A priority for the OKIS project is to recruit two people to bring the perspective of patients to our Project Advisory Group. We have prepared an advert and a description of the role to send out to relevant patient organisations.

In summary:

• The role of the Project Advisory Group is to make sure that the research takes into consideration the views of patients and healthcare professionals and to ensure the research is of a high standard.
• The project will last 12 months, starting on 1st April 2014
• The group will meet three times over the year and we might also contact you occasionally in between meetings.
• We were seeking two people who:
• Have been offered an orthotic device to help with knee problems related to a neuromuscular condition
• Are comfortable working as part of a small team
• Communicate effectively and are willing to share their opinions at a meeting and listen to the views of others
• Are able to attend meetings at the University of York– so live within easy travelling distance of York

The people who express an interest in joining the project will take part in a brief telephone interview and the successful applicants appointed. We will be offering an induction session and mentor from the team should they wish some support in their role.