Pulling everything together

We are now at the stage of reviewing the evidence and information collected in the various elements of this project and starting to interpret the findings. To assist in this process we are tapping into health professional and research methods expertise from the project Advisory Group.

At our third Advisory Group meeting the research team gave an update on each of the elements of this project. The systematic review has been completed and the discussion and recommendations sections are being compiled. The survey of health professionals has closed and the responses collated for analysis. The third element, the qualitative study of patients’ perspectives is almost complete with just a few more interviews to be held. In the meantime we have started coding and the data emerging are looking very informative in relation to the questions we set out to answer.

Meeting with the Advisory Group was a chance for the research team to ask the health professionals for their thoughts and advice. For example there was a discussion about how often patients are reviewed to assess how they are managing with an orthotic, a question in the healthcare professional survey. The Advisory Group suggested comparing this information with BAPO guidance on frequency of patient review. Some of the survey respondents dealt with in-patient groups and after discussion with the Advisory Group we will try to separate out the in-patient and out-patient results.

The next stage now is to complete the analysis of the qualitative study and write the full report for submission to our funders, the NIHR HTA programme. Once they received the report they will check it and send it out to external peer review. We will be asked to address any comments from the peer reviewers and then the report will be published in the NIHR journal library. We will also be disseminating the findings in a variety of other ways – which we will tell you about in another blog.

Blogger: Catriona McDaid

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: 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

Gaining research ethics approval

Early on in the life of a research study, researchers are required to submit details of their study to a research ethics committee for formal review.  A research study may raise a number of ethical considerations with regard to safeguarding the people taking part in the research.   Any research study that involves NHS patients in England must be submitted to the Health Research Authority (HRA) (formerly the National Research Ethics Service) for review. The HRA is committed to enabling and supporting ethical research in the NHS, while also protecting the rights, safety, dignity and wellbeing of research participants.  The HRA follows statutory regulations based on ethical codes and principles, such as those laid down in the World Medical Association Declaration of Helsinki, which places the interest of the research participant above those of science and society. The HRA is also concerned with protecting researchers who engage in research activities, sometimes referred to as ‘fieldwork’.

Gaining ethics approval may seem time-consuming at the start of a project, when everyone is keen for the study to get underway. However, it is a necessary part of research governance, a means of ensuring and maintaining good standards in research practice in the NHS. Research governance approvals also ensure that undertaking research in the NHS is complementary to the standard delivery of care. The Integrated Research Application System (IRAS) aims to streamline the research application process, incorporating research ethics, research governance and other regulatory requirements in a single application process.

For the qualitative interview study part of this project we have submitted a series of study documents to an ethics committee, whose members will read each one carefully.  The submitted documents include the plan for the study (also known as the study protocol), the letter of invitation to patients, the participant information sheet, which contains study details, and the consent form, amongst others. We have also provided to the ethics committee details about how we will gather and store research information, and how we will ensure confidentiality and anonymity for study participants.  The research ethics committee will not give their approval for the study to proceed until they are satisfied that the proposed research meets ethics requirements.

An ethics committee may require the researchers to change the proposed plan for the research to meet with their requirements. For example, committee members may feel that patients need to be given more time to consider whether or not they wish to take part in a study. The research ethics service undertakes to process applications within 60 days, though in many cases it will happen more quickly, particularly through a fast track process for low risk studies known as proportionate review.

Blogger: Dorothy McCaughan

Needles in Haystacks: Part 2: which haystacks should we look in?

Having decided what we are going to search for, the next important aspect of the searching is deciding where to look. In consultation with the review team we have decided which bibliographic databases and other resources should be searched and the words and phrases that will be used. We need to search different databases because they each include different literature.  Sometimes the content overlaps so we have to make sure we remove duplicate records from the search results, but it’s better to find something twice than miss it from a search.

A good systematic review must search at least Medline and Embase because these databases are the most comprehensive and important ones in health sciences.  Our search includes a number of other databases, for example CINAHL which covers a wide range of topics including nursing and allied health disciplines. We have also considered specialist databases, and are including the database PEDro which indexes the physiotherapy literature in our list of databases to search. We are also searching clinical trials registers to identify ongoing or unpublished studies. This should help make sure we find the most up to date research available.

Since starting this blog post I have now complete the searches.  I have identified 4233 bibliographic references for the reviewers to look through. Hidden amongst these will be the studies which might just help us find out which orthotics are most helpful for people with knee instability in neuromuscular disease and central nervous system disorders.

Blogger: Rocio Rodriguez-Lopez

Needles in Haystacks: Part 1: what sort of needles are we looking for?

For a good many of us, searching for information on a topic involves typing a word or phrase into Google and scrolling through the millions of hits! Searching for studies to include in a systematic review is a rather more rigorous process!  This two part blog will give you a flavour of what is involved.

Searches in a systematic review must aim to retrieve all the relevant evidence about the research question and follow a specific methodology, so that, if necessary, the search could be reproduced.  However, they also need to be conducted within the budget, time and resources available for the project. As Information Specialist for the project this is my responsibility.

My first job was to devise a search strategy that would be capable of identifying all the relevant studies. The medical literature is vast and indexed across a considerable number of bibliographic databases so it is important to be clear what you are searching for. Searches in a systematic review are based on the research question which is composed of four elements. For this review:

• Population is people with knee instability related to a neuromuscular disease or central nervous system disorder
• Intervention is orthotic devices
• Comparator is any used
• Outcomes  are any investigated

The main challenges of this project are the number of diseases and conditions of interest and the number of possible orthotic devices. Studies can be indexed very differently on different databases so it is important to think of all the terms that could be used to describe the devices. The clinical experts on our Advisory Group provided valuable input on the names of all the possible relevant orthotic devices, so we are confident that we will locate the relevant studies.

Because there are many, diverse neuromuscular diseases and central nervous system conditions, we could possibly miss some if we were to list them in our searches, even with clinical advice. It would make searches very long, unwieldy and time-consuming. Instead we plan to concentrate on finding studies that describe using an orthotic device to deal with knee instability. For the same reasons, the comparators and outcomes have not been included in the search.

Blogger: Rocio Rodriguez-Lopez

Checking we’re on the right course

Wednesday saw our first full Advisory Group meeting, where everyone involved could sit down, check on progress and discuss the next stages of the project. Logistically getting everyone together is never easy though we have found that at least initially it’s good to meet face to face so we can get to know each other. After that it’s easier to make the most of technology and have people join meetings with video conferencing.  As the project runs over 12 months there are only three such meetings planned and budgeted for, so it’s really important that we make the most of the time.

Plans for raising awareness of the project via this blog were agreed, with everyone getting involved in cascading links via their networks. These include key professional bodies, charities and organisations that provide support to people with neuromuscular diseases and central nervous system disorders.

Refinements were made to the details of the studies that will be included in the systematic review.  For example we had originally intended to only include studies with 20 participants or more. But as our clinical experts advised that few if any will include this many participants, we have removed the limit. This means we will capture as much of the evidence as possible in this under researched area.

We discussed the focus groups that will inform the survey of health professionals. Joanne our health economist presented the draft topic guide to the group. Through discussion she was able to add in some additional questions, for example, it will be important to find out whether patients are issued with a spare device or different devices at the same time.

We also discussed the best way of identifying patients to take part in interviews and the issues in recruiting from clinics and non-NHS settings. The routes we use will have implications for gaining both research ethics and research governance approvals, which can be lengthy processes. In order to make sure we include as many patients with a range of conditions we will be looking at using a variety of recruitment approaches so are exploring all the options further.

The structured discussion and resulting advice from group members was invaluable. The ‘Advisory Group’ lived up to its name and function: from offers of practical assistance in recruiting, to highlighting issues that might have been missed, to monitoring project progress.

Everyone agreed that it had been an interesting and positive meeting and certainly the advice from the health professionals was really helpful in informing the next stages. Now all we need to do is follow up on the agreed action points!

Blogger: Alison Booth 

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