AAGBI/Anaesthesia Research Grant

Aim
To identify which outcomes matter most to patients having major surgery.

Background
Every year, almost 10 million operations are performed in the UK. Most go well, but 10-15% of patients suffer medical complications, and 1-3% are fatal. Even the operations that 'go well' may not be completely successful from the patient's viewpoint - but we do not know, because we have never asked a broad range of surgical patients which outcomes really matter to them.

This study is about defining important outcomes after major surgery. It addresses one of the top priorities for UK perioperative research: the recent JLA Anaesthesia and Perioperative Care Priority Setting Partnership highlighted 'What outcomes should we use to measure the 'success' of anaesthesia and perioperative care?' as a 'Top Ten' research priority. Our research group aims to answer this by developing 'Core Outcome Measures' for anaesthesia and perioperative care - outcomes which are so fundamental, they should be reported in all research trials.

We have already completed a comprehensive review of recent research studies to identify the outcomes which researchers currently use in clinical trials. This study will explore the views of patients and carers with experience of major surgery, and the healthcare professionals looking after them, about which outcomes they consider most important. We will thus evaluate whether there are any substantial differences between the outcomes they deem important, and those which researchers currently use.

Methodology
Design: This study will involve surveys and in-depth interviews of adult patients with experience of major surgery (i.e. any big operation requiring hospital admission), and those with experience of looking after them (carers and healthcare professionals).

Intervention: 1) We will ask patients, carers and healthcare professionals to complete a short survey (approximately ten minutes) to rate the importance of seven commonly used post-operative outcome measures on a scale of 0-10. The survey will also ask them to suggest any other outcomes they think are important, and some basic demographic information. We will recruit 150-200 survey respondents, which will allow us to analyse differences between clinicians' views and those of patients and carers.

2) The final survey question will ask respondents if they are willing to have a telephone interview to explore their views on post-operative outcomes in greater depth. We will aim for 40-60 interviews, or until no 'new' viewpoints or perspectives are being obtained (termed 'theoretical saturation'). Interviews will be recorded and thematically analysed to extract the major themes. They will be 'semi-structured', i.e. the precise questions and content are not fixed, but will involve conversations about the following aspects of surgery:

• Expectations and preconceptions
  
• Worries or concerns
  
• Decision-making
  
• How they feel it went
  
• Evaluating care quality

Expected results and implications
The views of patients, carers and clinicians will provide valuable insights into what matters to patients having major surgery. This will help us develop standardised, patient-centred Core Outcome Measures which will improve the consistency and patient relevance of future perioperative research.

Aims
We will test if a structured preoperative questionnaire to assess physical fitness adds information to preoperative risk assessment. We will further test if the preoperative assessment of frailty with validated tools improves the prediction of post-operative complications.

Background
Cardiac complications are a leading cause of deaths and other adverse outcome following noncardiac surgery. Detailed guidelines on preoperative cardiac risk assessment have been issued in the Europe and the United States. These identify assessing physical fitness as key to risk assessment. The association between exercise tolerance measured by formal exercise testing and surgical outcome is well established. The estimation of functional capacity generally rests on informal questioning of the patient. Studies suggest that patients tend to be poor at estimating their functional capacity. Data are available on the energy expenditure associated with daily activities, quantified in metabolic equivalents or METS. Using this information it is possible to construct a structured questionnaire to make the estimation of physical fitness more robust and reproducible. MET-REPAIR study is a Europe wide study that aims to test a structured questionnaire on functional capacity for the prediction of the outcome of non-cardiac surgery in a population of 15,000 patients. We will conduct MET-REPAIR in the UK and aim to recruit 1,000 patients.

MET-REPAIR-FRAILTY is a study that will be added on to MET-REPAIR in UK centres. Frail elderly patients are more likely to suffer complications following surgery. However, it is not clear if frail patients are at increased risk of surgical complications because of their general lack of physiological reserve or because of the co-existing diseases to which they are that they are prone. The Clinical Frailty Scale, the Edmonton Frail Scale, and the timed walk test are rapid frailty assessments that would be suitable for use in a clinic seeing a large number of patients. Primary care data may also be of value. Primary care in the UK is supported by robust electronic patient record systems. An electronic frailty index embedded in these systems has been developed. As well as collecting the data required for MET-REPAIR we will conduct these additional assessments in patients entered into the study in UK centres and conduct analyses to determine if the additional information from frailty assessment improves the prediction of postoperative complications.

Experimental Design
MET-REPAIR-FRAILTY is a prospective multi-centre study. Any hospital carrying out non-cardiac surgery may participate. Centres will enroll a minimum of 50 patients over a recruitment period of 12 consecutive weeks.

Methods
Following consent data will be collected in the pre-assessment clinic on functional capacity, frailty and other risk factors for complications. Information on postoperative complications will be collected at discharge and patients will be also contacted by phone at Day 30 to identify post-discharge complications. The patient's general practitioner will be contacted and a limited data extract of data to calculate the electronic Frailty Index (eFI) will be requested. Statistical analyses will be conducted to determine if questionnaire determined functional capacity and data on frailty improves the prediction of postoperative complications.

Background
Work-related upper limb disorders (musculoskeletal disorders involving the hand, wrist, shoulder and neck) are common in the NHS. Anecdotally, anaesthetists are prone to these, especially neck problems, and this is often put down to anaesthetists' posture/positioning during airway management (typically, bending forward over the patient's head whist extending the (anaesthetist's) neck), although anaesthesia is a very practical specialty and there are several other anaesthetic procedures that may also involve poor posturing. There is very little, if any, published information about upper limb disorders in anaesthetists, but this is potentially a very important issue since these disorders may pose a risk to patient safety (through impaired performance of practical procedures and/or inability to work), as well as to anaesthetists' health.

Aim
Our aim is to ascertain the prevalence of upper limb disorders in anaesthetists in the UK and Ireland, and explore any relationships with a few potential risk factors.

Methods
The methodology proposed is to conduct a survey of all ~11,000 members of the Association of Anaesthetists of Great Britain & Ireland, following a 1-2 month period of raising awareness of the survey via the AAGBI, asking a limited set of questions to identify upper limb disorders and a few potential risk factors such as age, height, weight, gender, etc. The questions will be limited and focused, to encourage a good response rate, with the potential for a follow-up study to explore some conditions/risk factors in more detail. The survey will be set up and administered by a company that has been used by the AAGBI before, and the associated cost of the current project arises from its involvement. The results from this survey will be presented/disseminated in order to raise awareness and inform any subsequent steps around education/training and attention to the ergonomics of the workplace.

Major elective surgery has an average mortality of 4%. Breathing problems are the commonest complications after major surgery and anaesthesia. It is therefore very important to look for ways to reduce this morbidity and mortality. The proposed study is the third in a series examining ventilation techniques in major surgery, in obese patients and now patients requiring ventilation on one lung only. During major surgery most patients require mechanical ventilation to allow adequate transfer of oxygen from the lungs into the blood stream and removal of CO2 in the other direction. Unfortunately, although vital for surgery and a life-saving technique in the critically ill, mechanical ventilation does have disadvantages. It works by blowing air into the lung under positive pressure, rather than drawing it, as is the case with natural breathing.

This means air is distributed to the upper parts of the lung, often causing over stretching of the tissues. Conversely, far less air than normal goes to the bottom of the lungs because the air passages here are compressed by the weight of tissues above them. This causes these air passages to collapse. One-lung ventilation (OLV) is frequently required to allow thoracic surgery. Unfortunately, postoperative lung complications (PPCs) after thoracic surgery employing OLV are even more common. How to best reduce the incidence of PPCs in terms of ventilation technique isn't known.

Therefore, the aim of this study is to determine what level of pressure should be maintained in the lung at the end of each breath, in order to prevent the lung collapsing, without causing problems with impeding blood flow through the lung. The grant application is to fund the UK arm of a multinational study of patients who are having lung resection surgery and therefore require one lung anaesthesia and ventilation, because the other lung is involved in the surgery. It compares two levels of PEEP, selected on the basis of what other studies have found helpful/unhelpful, which is the pressure in the lung at the end of each breath, to determine which best reduces lung complications after and during surgery. As a secondary aim, complications in other body systems will be recorded, as well as the need for unexpected intensive care admission; number of hospital-free days at day 28; survival rate at day 90; oxygen and CO2 levels in the blood. In the UK we will aim to recruit a minimum of 72 patients in six sites (6x12).

This is the third in a series of studies undertaken by this group looking at how best to reduce respiratory complications after surgery by modifying the method of ventilation during the surgery itself, where many of the seeds of damage are sown. The aim is to fund the UK contribution to a study of over 2,000 patients, which the applicant helped design. It is hoped that this will contribute to the knowledge of how best to reduce respiratory complications after surgery, which is a very serious contributor to postoperative morbidity and mortality after lung operations.

Background
Emergency bowel surgery ("emergency laparotomy", EL) is a common and high-risk operation. Patients are often elderly and frail. They are at high risk of serious problems due to their illness and surgery. Patients often need a long stay in hospital after surgery, and many do not survive. The National Emergency Laparotomy Audit accurately measures death rates after EL in England and Wales. Up to date analysis shows that about 11% of all patients, and about 20% of those over 70 die by 30 days after surgery. This is a much higher rate than almost all non-emergency surgery.

Less well understood is the impact of EL on those who survive. For example how well they can care for themselves, how often they need to return to hospital, and the risk of dying later on during their recovery.

Aims
Our ultimate aim is to improve the services we offer patients around the time of surgery, but to do this effectively we need first to understand how much patients are affected by their surgery. Our study has been designed to record how commonly medical problems arise following EL whilst the patient is still in hospital. In addition, we will follow patients for one year following surgery, and measure how much their day-to-day lives have been affected by their surgery. We aim to test our proposed methods at our own hospital before designing a bigger study which would give information from a wider group of patients.

Methods
Patients that have undergone EL will be offered the opportunity to take part in research. We will ask their permission to collect data about medical problems following surgery, as well as for us to contact them after discharge from hospital to complete questionnaires. We plan to use questionnaires at 1, 3, 6 and 12 months following surgery to gather information about their day-to-day ability to care for themselves, how their memory and mood has been affected by surgery, and any ongoing pain problems. We will use GP records to help give an idea of how much support patients have needed in the community during the year.

Participants and Duration of study
During a 3 to 4 month period, we predict that about 70 patients will undergo EL at the RVI. We aim to approach all of these patients to ask them to consider taking part in the research. Experts at Newcastle University have suggested that collecting data from 50 to 70 patients will give us useful information in designing future and larger studies.

The final questionnaires should be completed 16-18 months after the study begins.