SNAP-1 Archive: FAQs

SNAP-1 patient recruitment will take place from 00:01 on Tuesday 13th May until 23:59 on Wednesday 14th May with follow-up of patients also occurring on Thursday 15th May.

All adult (18 or above) patients, undergoing any type of non-obstetric surgery in an operating theatre, in an NHS hospital in the UK during the study period are eligible to be included. This includes both day case and in-patient surgery as well as planned elective cases in addition to urgent or emergency operations. Endoscopic or interventional radiological procedures carried out under GA or sedation given by an anaesthetist should also be included.

Exclusion criteria include patients <18 years old, those who are unable to understand either spoken or written English, obstetric patients, patients who are too unwell or confused to be able to complete the questionnaire or those who decline to participate. Non-surgical interventions, such as 'pain procedures', ECT or anaesthetic room procedures (e.g. CVC insertion, LP) are also excluded.

There should be a maximum of one Local Lead Investigator (LLI) for each hospital site; this may mean that there are multiple LLIs within a trust/health board depending on how many sites they cover.

There is no limit to the number of Local Investigators that can register at each site. The number of LIs required will vary widely depending on how many operations are performed over the study period and the layout of services within individual hospitals.

This must be a consultant, and may be the Quality Audit and Research Coordinator (QuARC), Clinical Director, Audit Lead or another nominated consultant within the department.

Anaesthetists at any stage of training (including Foundation Years) or consultants, those in non-training posts and research nurses are all eligible to register as an LI.

SNAP-1 is only including patients 18 years and over. As occasionally non-paediatric patients undergo procedures in paediatric hospitals, you may still register to take part in SNAP-1 and collect data if any adult patients are operated on in your hospital over the 2 day study period

No. We would encourage any hospital with an anaesthetic department that performs non-obstetric surgery in patients over the age of 18 to take part. Even if there are only a small number of eligible cases over the two study days this information will still be of value and contribute to the project as a whole.

Yes. The NIHR CRN ID for the study is: 16249. The Integrated Research Application Service (IRAS) number for the study is 138384.

Yes. The national target for SNAP-1 patient recruitment is 7500. We are not setting target recruitment rates for each individual site for the study.

Regarding CRN support costs, the Central and East London LCRN, as Lead Network for this study, has agreed that following:

As per the AcorD guidance, the activities such as taking consent and local data collection would be considered NHS support costs. NHS support costs being evident over such a congested time period is rare, however, that does not preclude any Network being able to support the study.

This means that the study is eligible to receive NIHR NHS support costs, to compensate for the time taken to conduct the study. In addition, if your site has research nurses, participation in this study is a valid activity for them, and the study will count towards your site's targeted accruals into national studies.

The favourable opinion given by the West Midlands NRES Committee applies to all NHS sites taking part in the study, subject to R&D approval being obtained from each participating NHS organisation.

We are updating the NIHR with a list of sites which have registered LLIs on a weekly basis. Following this, the R&D department at each Trust will be notified and will begin their checks.

For Trusts in England, the single SSI (Site Specific Information) approval process means that no local SSI form needs to be created or signed by LLIs - a single national SSI has been signed on their behalf by the Chief Investigator (Dr Ramani Moonesinghe). Thus, all that you need to do is to ensure that your local R&D department is proceeding with their local checks and cooperate with their local requirements - including providing a CV and/ or evidence of recent GCP training if that is required of LLIs (see below for more information about this).

For Health Boards and Trusts in Scotland, Wales and Northern Ireland, the process is different. We have been in touch with LLIs in each Trust/Health Board to obtain the information required for SSI forms.

Requirements for GCP training are determined locally and all Local Lead Investigators (LLIs) will need to ensure that each registered Local Investigator (LI) is appropriately trained to meet their own local R&D requirements.

As SNAP-1 has been adopted on to the NIHR portfolio GCP training can be undertaken for free online via the National Institute for Health Research (NIHR) website by entering the name of the project: 'A national survey of patient reported outcome after anaesthesia' or the NIHR CRN ID: 16249

http://www.crn.nihr.ac.uk/workforce_development/learning_and_development/gcp/gcp_elearning

The online training only takes 2-3 hours to complete and can be done in several sittings if required. We would encourage all of those who register as LLIs/LIs to complete it prior to SNAP-1 even if local requirements do not mandate it.

We have put together some guidance to help you complete your GCP training online:

 GCP E-Learning Instructions.pdf (565 KB)

Please refer to the SNAP-1 Protocol for a full explanation of the study.

There are three separate paper based questionnaires to be completed for each participant which are available to view on the SNAP-1 website.

The questionnaires will be printed on a single folded A3 paper document so that the responses to all 3 questionnaires are kept together.

We will also ask LLIs to provide a figure for the number of operations performed in their hospital over the two study days in order to be able to calculate a recruitment rate.

No. Patients should be provided with a patient information sheet on their admission to hospital prior to surgery and completion of the questionnaires subsequently will demonstrate their consent to participating.

This approach has been approved by the West Midlands NRES Committee, who provided favourable ethical opinion for this research project.

Yes. We will post papers versions of the questionnaires to all registered sites and have asked LLIs to provide an estimate of the number of patients that they are likely to recruit over the two day study period depending on their hospital workload. the 3 questionnaires (patient demographics/perioperative information, patient satisfaction and patient reported awareness) will be posted to registered hospital sites in a single folded A3 document in the week beginning Monday 28th April 2014. Each of these documents are available as PDFs via this website so that you can print extra forms locally should these be required: http://www.niaa-hsrc.org.uk/SNAP_Documents

We will be asking you to amend and print the Patient Information Sheet (PIS) locally. The reason for this, is that the Ethics committee requires you to have the name of the LLI and the telephone number for your PALS office on the forms. We will provide an electronic version of the final version of the PIS to you by email by the beginning of April.

The basic demographic and perioperative information should be completed at the time of surgery by the anaesthetist responsible for the patient's care in theatre. If any of this information is missing then local investigators (LIs) are encouraged to obtain this data retrospectively from the patient's hospital record/anaesthetic chart.

Following surgery each eligible patient should be approached by one of the LIs and asked to complete the two patient questionnaires (Bauer patient satisfaction and Modified Brice).
The above information will all be completed on paper copies of the questionnaires.

This will depend on whether they are undergoing surgery as a day-case procedure or an in-patient.

If they are having day-case surgery they should be approached prior to their discharge from the Day Surgery Unit (or local equivalent) on the day of their operation. If they are to remain as an in-patient then depending on the timing of their surgery they may be approached later the same day or on the following day (i.e. within approximately 24 hours of their operation). We would suggest that in-patients are approached for follow-up as early as possible on the following morning. During a pilot study a number of patients were lost to follow-up as they had already been discharged from hospital by the afternoon following their surgery.
Patients will be asked to provide the date that they complete the questionnaires.

The information collected on the paper questionnaires will be transferred via an online data collection web tool.

Each of the pre-registered LLIs and LIs at participating sites will be provided with login details for the web tool that will allow them to create and view individual patient records for their hospital.

Yes. The web tool allows incomplete patient records to be saved and returned to at a later stage. In order to ensure the integrity of the data we would recommend that as far as possible individual records are completed at one time. However, if missing demographic or perioperative data is obtained in retrospect from the patient's hospital records/anaesthetic chart this could be added at a later stage.

Yes, but this will not be transferred outside the local hospital environment either electronically or on paper. Each hospital will have to undertake to store the information collected confidentially, in order to fulfil local R&D checks for the study.

Each patient entry on the database will generate a unique identifier; Each site will be asked to keep a log of the unique identifiers linked to local hospital identification numbers. We will provide a template for this log. This local log is necessary in order to ensure that all potential cases of awareness as detected by a patient's responses to the Modified Brice questionnaire, are followed up appropriately.

The web tool has been designed to 'flag up' potential cases of awareness depending on a patient's responses to the Brice questionnaire.

The SNAP-1 researchers based at the UCL/UCLH Surgical Outcomes Research Centre in London will have access to completed patient records prior to closure of the web tool. Any such cases that are 'flagged up' at this stage will be referred to an expert panel of assessors (consultant anaesthetists and lay representatives who have been members of the project board of NAP5). If after this stage there is still concern that the patient may have experienced awareness, then the local investigators will be contacted and asked to refer to the locally held log in order to identify the patient.

LLIs will be responsible for contacting the patient and following up this potential case of awareness according to their own departmental guidelines.

Yes. LLIs will be able to access their own local data as it is entered. This will be in the form of an Excel spreadsheet that can be generated via the 'export' feature on the web tool.

The data collection web tool will be closed in June 2014. The RCoA have agreed that they will continue to fund the web tool for a further 12 months (at which point the provision of on-going funding will be reviewed) following the completion of SNAP-1. This will allow individual departments to continue to measure patient satisfaction in at least a sample of their patients and to compare their local outcomes over time.

We intend to present the results online via the study website, in a peer reviewed scientific journal and in the form of conference presentations. The exact timing of these will depend in part by the number of responses and the time taken to analyse the data. Updates of likely timings will be provided via the study website and LLIs/LIs will be contacted via email to inform them when the full results are available.

All registered LLIs and LIs will be named as collaborators in any future publications resulting from SNAP-1. We would like to thank you for your participation in SNAP-1.