What has been happening in Sheffield CRP!

May 2013 : Attendance at conference in Glasgow (courtesy of ICPV) and a particularly interesting talk on creating a patient-friendly lay summary. Also Jim Elliot on the value of PPI in research. (Printable version)

April 2013 : Access to Information, report on a focus group organised by Mark Taylor, Chair at Confidentiality Advisory Group; Senior Lecturer in Law at University of Sheffield. Members of CRP took part with others, in discussion about access to identifiable patient data without consent, for use in research. (Printable version.)

May 2013

How to write a lay summary. By Helen Bulbeck of Brainstrust. Printer friendly document here.

Jim Elliott and Helen Bulbeck of Brainstrust looked at how to write a lay summary, and Patient and Public Involvement (PPI) in research.

1 Lay summaries – Helen Bulbeck.

This presentation was given at the request of NIHR at conference, 2012.

Lay summaries are important because they express the thoughts of the researcher in terms that patients looking at entering clinical trials can easily understand. A readily comprehensible summary in the patient information sheet is a’ must’, so patients will join a clinical trial understanding the concept behind the research and how it might benefit them. A well written summary is also useful for lay reviewers who are members of funding and ethics committees.

Many lay summaries are merely shortened cut-and-paste copies of whatever has been written in the trial protocol. Jim and Helen showed that this can be much improved upon, and with researchers, developed guidelines for the creation of a good lay summary.

Helen first defined a lay summary and its purpose, then covered general principles. A poor example was compared and contrasted with one which was well written.

Remember that the audience for this lay summary is very heterogeneous, and ranges from lay people of differing educational attainment to experienced intellectuals.

Patients in consultations or clinic are under stress, so use plain English. This means no long words such as concomitant, use of short sentences with a maximum of 15 to 20 words, and use acronyms only after the full term has been used and explained. For example, Health Research Authority (HRA).

Do not use compound sentences with many clauses and sub-clauses.

Analogies and metaphors are good, to aid understanding. For example, ‘nerves are like cables and are covered in an insulating material called the myelin sheath’.

Use second person words, such as ‘you’, not ‘the patient’. Use scientific terms after it has been put into plain English. Eg ‘your prostate will be removed (prostatectomy)’.

Speak in the active sense, eg ‘you will have radiotherapy’, not ‘radiotherapy will be given to you’.

Use connective words to develop links between ideas, such as ‘although’, or ‘however’.
The lay summary should be right at the front of any document, and always remember it is being written for the patient, not the researcher.

Consider that the patient may have a poor prognosis, but this should not be anywhere in the summary. Neither should the word ‘death’ be given as an outcome – it will render the study very unattractive to patients. Always reference quality of life, as this is of prime importance to the patient.

Include a glossary of key words and acronyms.

The result of all this? Engaged patients who enter trials.

See the Brainstrust principles for a good lay summary. (Link to Brainstrust document here.)

Brainstrust can be found here: http://www.brainstrust.org.uk/index.php.
Thank you to Helen Bulbeck of Brainstrust for permission to circulate the summary template.

2 PPI in research – Jim Elliot.

Jim Elliot listed basic principles of good practice.

Research projects and studies should have a lay person as co-applicant, who is of equal status.

Find tasks the lay person can do. Examples may be design of questionnaires and forms, and writing the lay summary. Do they have the skills or is training required, in which case it should be provided. How can the lay person add value for the researcher.

PPI should always be properly financed and budgeted for. Reimburse for travel and expenses. Pay for time used in meetings and conference, and working, at the approved INVOLVE rate. (Currently £10 per hour at May 2013)

The study is about the patient, not the researcher. There is no point in doing the study if it does not make a difference to the patient in terms of quality of life, or improved survival.

Lay/patient advocates can increase recruitment using social media such as Twitter, Facebook, and podcasts.

Lay/patient involvement in funding panels can influence decisions in favour of what matters to patients and prioritise topics. Vacancies for such panels are advertised.

The delegates were then divided into three groups to study practical effects of PPI on trial design. A few examples are as follows:

Contribution to QoL aspect of studies, asking questions of patients and carers separately, to account for different views. PPI can improve QoL studies.

Change questionnaires to ensure questions are meaningful and relevant to the patient.

Lay advocates can say things academics cannot or will not.

Ethical issues can be discussed and addressed prior to going to Ethics Committee.

Jacqui Gath May 2013

April 2013

Access to Patient Information Without Patient Consent

What is important to the public?

Focus Group 9 April 2013 at ICOSS Sheffield
held by Mark Taylor and David Ardron.

Why the day?
This is a research project gathering views and opinions from three groups of people who have used, or potentially may use, healthcare services.

The background is new legislation enabling the gathering and use of non-anonymised patient data for medical research subject to the satisfaction of certain conditions, including the proviso that access is in the public interest.

Along with 7 others, I was invited to attend on 9 April, because I am an NHS patient and my data could be accessed for use in research. The objective of this project is to find what patients think about different concepts of ‘public interest’ and what trade-offs may be acceptable in return for this non-consented access to our data. These views will guide development of a concept that will help guide those making decisions on allowing access.

Delegates in this group were white middle-class middle-aged people, with a higher education, so not representative of the population as a whole. Also, the majority were women. However, there was a full spectrum of views, from preferring to be totally in control of the use of one’s own data, to the view that in matters of health, the rights of the individual are totally subsumed to the well being of the State.

There were two other groups, the second being members of the North Derbyshire General Practice Patient Participation Group and the third being staff and students of Sheffield University.

The study is being organised by Dr Mark Taylor (University of Sheffield School of Law) as part of a larger piece of research funded by the British Academy and for which he has been granted funds. The study has been approved by a Research Ethics Committee. Mark confirmed that his intention is to publish the results of the study in a peer reviewed journal, and that pre-publication copies will be available to delegates; outcomes will be presented before publication. The results will also be presented to the governing body, the Confidential Advisory Group, or CAG.

Background to the study
The morning started at 10:30 after coffee, when the delegates introduced themselves to each other, demonstrating the wide and different range of expertise and experience in the group. Mark outlined the purpose of the research with two very clear presentations on the legal background to the use of data, and introduction to the concept of public interest in this context. After lunch, debate (sometimes vigorous) was well moderated by David Ardron, Lay Facilitator. The sessions were recorded, and delegates were assured that their comments and views will not be attributed to named individuals in resultant papers, articles, and presentations.

The potential benefits of the use of personal data in health research was acknowledged by all delegates. The need to use anonymised data is driven by the need to link data from different databases. (note that data will be linked to and accessed from the police, Department of Work and Pensions, Department of Justice, HMRC – in fact, any government database currently or potentially in existence). After the data is linked and extracted by an Information Centre (IC), it will be sent to the researcher in anonymised form for the research work to be done. The IC acts as an honest broker, subject to strict controls and an enforceable Code of Practice, with penalties for non-compliance.

It was noted that the Health and Social Care Act 2012 has the power to mandate disclosure by health professionals to the Information Centre, but all research projects will need to gain permission from an Ethics Committee before going ahead. The view has been taken by CAG that individual patient objection will not be over-ridden.

There is a need for privacy, and also the need for research to manage the nation’s evolving health needs, improve the health of citizens, and enable timely and adequate response to serious health threats which may threaten the State. To ask for consent for data to be used is not practicable as data from many thousands of people will be needed and used. However, there are potentially important trade-offs: the public will benefit from better care, preventive care may be targeted to individuals at risk of particular conditions, anomalous health care findings may be passed to individuals so that they may take action to mitigate development of a condition.

Points for discussion
Mark asked us to consider how much individual control (of one’s own data) is in the public interest, and that public interest is very difficult to describe. We were asked to consider common interest eg the benefit of clean water and street lighting from which everyone gains but nobody votes on or can decline to use, and something for the pubic good which may be called upon when necessary, such as the police and fire service. We were also asked to consider that confidentiality is good for public health, because if patients are confident that information about them will not be disclosed, then they will use effective health services and not self-treat.

Finally, it was put to us that a first argument would be that 1) the reasons for disclosure are understood by the patient, and that 2) those reasons are acceptable. So the questions for the group were:

• How acceptable are the reasons for disclosure
• What tradeoffs are acceptable
• Which tradeoffs are not acceptable
• If opt out is permitted, what is a reasonable objection to enable that opt-out

Delegates were asked to prioritise 4 scenarios, and indicate whether they were acceptable or not, before discussion commenced in the afternoon. The scenarios ranged from access to all data without consent for any purpose, to access to data being requested from each individual research participant upon each use.

The following points were raised and discussed:
The reasons for disclosure must be publicised, and use made of websites, notices in pharmacies, GP surgeries, libraries. It was noted there are groups who are difficult to reach yet must be reached, for example immigrant communities, and those who cannot read. Mention was made that use of TV advertisements and public radio service could perhaps be utilised here.

Trade-offs – there must be policing and audit to make sure that data is used as described in the research application. Data needs to be tidied up and quality improved. Linking data by means of just name and date of birth can give rise to many anomalies. Use may be made of the National Insurance number allocated to every individual at age 16, but this will need to be allocated at birth. Better care, better health, better use of national resources are all envisaged.

What is unacceptable – mission creep, where once the initial concept is embedded in daily life the linkage and use of any data is extended and permitted by changing the law; selling data eg to private insurance companies – the spectre was raised of insurance company researchers analysing data for product design which may lead to discrimination. Also thought unacceptable is research done for purposes beyond the moral spectrum of the data owner – assuming the data owner is the health care user. (In fact, it has been decided that the State owns NHS data.) Examples may be for military purposes (The American Military have shown interest in the use of tissue banks and health data), and use with animal experimentation. It was noted that modern database technology enables the easy use of flags to note conditions placed upon the data, and subsequent reporting/extract.

Finally, when should individual objection be over-ridden? The main concern was in the case of global or national pandemic seriously affecting the nation’s health, and when there is serious risk to the security of the State.

Other points which came up during discussion were that all health institutions should come within this legislation, both public and private, and concern was raised about the highly personal and confidential nature of some data held in GP records.

At the close of the discussion, we were asked to re-complete our scenarios and whether or not they were acceptable or unacceptable, to find whether our views had changed.

There is plenty for Mark Taylor to reflect on when he is analysing and reporting on his findings and delegates look forward to reading them, and attending the follow-up session in September. For myself, the use of focus groups may mean that only particular sections of the community currently take part in this democratic process, but it can only be beneficial that views about the implementation of the Act are being sought, and the views of citizens taken into account. I hope the process is broadened and strengthened – for the public good.

Jacqui Gath