What is the purpose of the study?

The purpose of the study is to understand what influences the well-being, motivation and confidence of FY2 doctors in the ED and how this is linked to the quality of care they provide. There have been a number of policy initiatives aimed at improving the experiences of the NHS workforce (including postgraduate doctors) and evaluation of these initiatives is aimed to measure their successes and failures.

Who is conducting the study?

The work has been funded by the NIHR Service Delivery and Organisation (SDO) Research Programme. It is being undertaken independently by a research team, led by a senior medical doctor based at the University of Sheffield. The research is being conducted independently by the research team.

Why have I been selected?

You have been selected because your FY2 programme is organised by a deanery which has agreed for you to be approached regarding participation in the study AND because you have an FY2 placement in the ED.

Do I have to take part?

We understand there are various expectancies placed upon you in your roles but please be assured there is no pressure on you to participate. A decision to take part in this study is voluntary and it is your decision entirely whether to take part or not. Any decision regarding your participation will be confidential between you and the research team. You are also free to withdraw from the study at any time without any repercussions to yourself.

What does agreeing to take part involve?

If you agree to take part you would participate in the longitudinal observational study for the full 12 months of your FY2 year. The research study is funded for 33 months in total.

• Initially some limited contact details (name and email address) will be entered onto a database in order that we may contact you about the study when necessary to do so. A study ID will be assigned to each participating doctor which will substitute for these contact details as a means of ensuring anonymity of participants.
• Your main involvement would be to complete a questionnaire up to a maximum of four times during your FY2 year. You will be contacted by email in order that a link to an electronic questionnaire can be provided at the appropriate time points. Alternatively you may receive a postal questionnaire if this is considered a more appropriate method in your department. The questionnaire will use validated measures to assess your well-being, confidence and motivation at key time points in your FY2 year. It will take in the region of around 15–20 minutes to complete.
• In addition, a random selection of ED notes, in which you were the primary care giver during your ED placement, will be reviewed by experienced ED clinicians in order to assess the quality and safety of care provided. This process will take place retrospectively, after you have left the ED. This process will be carried out exclusively by the reviewers and the research team. A member of the clinical team in each ED will identify the relevant notes for all participating FY2 doctors in each participating ED. The research team will randomly select a small sample of these notes for each doctor. Each set of notes will be fully anonymised and the relevant doctor study ID assigned. In this way the reviewers will be blinded to who has carried out the care.
• Data collected from you, from the survey and the notes review, will be analysed independently by the research team. All data collected will be entered onto a database which will be fully anonymised. Your personal details will not be stored on this database. Data collected from you will be aggregated with the data of the other participating trainee doctors in your department in order that relationships between well-being and quality can be measured at the department level and variation across participating EDs can be measured. In this way no individual doctor’s well-being or quality-of-care scores will be reported. There may be instances where a participating doctor’s research scores may need to be examined on an individual basis. The quality-of-care scores for an individual doctor may be such that there is evidence that patients are being put at serious risk. The processes to be followed in such instances are described below under confidentiality and data protection.

What about confidentiality and data protection?

All information you may give will be treated in the strictest confidence. It is possible that we will hold limited electronic information about you such as your name and email address. This information will be held purely for the means of contacting you about the study where necessary to do so. After the study is complete all names and email addresses will be deleted.

No individual FY2 doctor will be identifiable at any stage in the publication or presentation of the findings. Data collected will be stored securely in a manner consistent with the Data Protection Act.

Exceptional circumstances where breaching of confidentiality may be necessary

Unless exceptional circumstances demand otherwise, individual identifiable study data will be kept confidential at all times between yourself and the study team. There are instances where data confidentiality would have to be compromised and information disclosed to an individual outside the research team. They are as follows:

1. If included clinical notes were reviewed and detailed care which may have put a patient at serious risk, then the identity of the doctor who provided this care would be disclosed. The relevant ID number of the participating doctor would be disclosed to the lead consultant of the department by the doctor carrying out the case notes review. Any action taken would be at the discretion of this lead clinician, but may include contacting the relevant participating doctor to discuss the matter further and recommend any necessary support. The types of errors which may result in this course of action are as follows: serious medication errors and unidentified missed conditions such as a missed fracture.
2. If you were interested in receiving feedback regarding your scores on the well-being survey or the quality of care study then this could only be provided by accessing your personal identifiers in order to select the relevant data and send a summary to you.

What are the risks of participating?

We understand that there are many demands on your time and there is some inconvenience in completing surveys. As described above there may be instances when confidentiality has to be broken and your results from the study discussed with a third party.

How will I benefit from this study?

We believe there are benefits to taking part in this study. If you specifically request the information from the research team, you will be able to receive feedback on your individual scores from the well-being survey and the quality of care study. As stated above, in order to provide this information your confidentiality would have to be breached.

What will happen as a result of the study?

The data collected from you will be aggregated with the data from other FY2 participants and this will be analysed and used to produce a report which will be made available for all participants. This report will be published by the funders of the study and will be available to inform policy decisions around postgraduate training.

Who has reviewed the study?

All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee, to protect your safety, rights, well-being and dignity. This study has been reviewed and given favourable opinion by Leeds East Research Ethics Committee on 30 September 2009. The study has also been scientifically reviewed by independent peer reviewers prior to funding being given.

What should I do now?

You should take enough time as you feel you need to consider whether to take part. If you do wish to take part, there is a contact email/number for the study project manager to reply to below. The research team will then forward a consent form for you to sign along with the details of when the study will begin.

What will happen if I don’t want to carry on with the study?

If you agree to participate but then decide to withdraw from the study, then there will be no repercussions for you. Any data we have collected will be analysed as planned but you will not receive any additional questionnaires nor will your notes be included in the review of quality of care.

Further contact

If you have any further questions then please feel free to contact Colin O’Keeffe.

Thank you for your time