Update January 31, 2013
Correspondence to the orginal Lancet manauscript has now been published in the Lancet.
Mortality after surgery in Europe
Update September 22, 2012
Update March 19, 2012
Over 46,000 patients were enrolled into the study last year. Data cleaning has been progressing very well with the excellent help of the ESA office staff and the University of Lisbon. Data analysis has now commenced and we are hoping that some important results will soon be available to all.
Update April 25
Congratulations! We have now collected data on our 10,000th EuSOS patient onto the eCRF. This alone is a fantastic achievement but we know that a large number of you are waiting until after Easter to upload your data. The final total looks set to be much higher!
Of course we still need to make sure we capture all the data we can and then carefully check this for errors before we can get stuck into the analysis. If you are still waiting to upload your data, it is as important as ever to make sure you return this carefully.
Many of you have been kind enough to e-mail us to say how EuSOS has gone in your hospital. There have been a few great stories. If you have any interesting EuSOS tales to share please do let me know!
Once again, our thanks and congratulations for a really outstanding job.
Update April 15
The data is flowing in fast with several thousand patient episodes already loaded onto the EuSOS eCRF.
I realise we have provided a lot of feedback on eCRF problems in the past week. To make the process simpler I have prepared the attached document which I hope will help you solve the most frequent problems which have been reported to us. Can I ask you to make sure that all investigators in your hospital recieve this e-mail. Some investigators may not find it easy to access this guidance for different reasons. Please support any colleagues who enter the data on the eCRF and make sure they are aware of the advice.
Many thanks for your hard work and patience with the eCRF.
Rupert on behalf of the EuSOS steering comittee
Update 11 April
The data collection week is now finished and the focus is slowly switching to returning the data through the eCRF. I think most of you have now managed to access the site - certainly we have seen a large number of patient episodes uploaded in the last two days. It is very exciting to watch as we still dont know how many patients we will recruit but it looks like a lot!
However, it does seem that our main problem is still the eCRF. Some of you have spotted errors which we thought had been corrected at the design stage. The company tells us we cannot change these now the eCRF is live on the servers. I am not too happy with the situation but I am afraid I must ask you to help with pragmatic solutions:
Critical Care CRF: In the 24 and 48 hour pages, the system will only allow you to enter integers (whole numbers) for creatinine and bilirubin when using units of mg/dL. This problem does not affect any other part of the CRF. There are two solutions - option one is easiest - You can convert the data to micromol/L.
To convert creatinine from mg/dL to micromol/L multiply by 88.4. To convert bilirubin from mg/dL to micromol/L multiply by 17.1.
You will still need to reduce the value to the nearest whole number. The second option is to enter a discrpeancy note by clicking the blue / red flag next to the data box. You may then enter the value in mg/dL there.
Operating room CRF: Units for urea / BUN: There is a typographical error. The units that are decsribed as micromol/L but are in fact mmol/L. Please read mmol/L where it says micromol/L and enter your data as normal - most of you are doing so already.
All CRFs: We do not provide the option to enter Haemoglobin data in mmol/L. This is my fault. I did not realise that many hospitals used these units but it seems many hospitals in Denmark, Germany and the Netherlands do so. Again all we can do now is to ask you to convert these data yourselves before entry.
To convert from haemoglobin in mmol/L to g/dL DIVIDE by 0.62. A discrepenacy note is again possible but we think you will find converting the data your self an quicker option.
Once again, I am very sorry for the inconvenience caused by the eCRF which is not working as well as we had hoped. However, these are minor problems given the overall size of the study and the budget we had available!
Thanks for supporting EuSOS. I think we will have some very good news on the patient sample size in the near future.
Update 09 April. Study day 6
Many thanks for all your hard work during the EuSOS week. We are now on the final leg with a few emergency cases to capture over the weekend before the cohort week ends. I am pleased to say that your feedback is that data collection is going very smoothly with few problems. Many of you have contacted us with data queries and this has allowed us to clarify points with the whole group.
As you might imagine, we have been closely monitoring activity on the ID generator and eCRF. We are still in the earliest stages of data return but already it seems that we have recruited a very large patient sample into the EuSOS study. In most hospitals, patients will be followed to discharge before data is uploaded and so it is too early to estimate the final sample size. However, we are confident that the final total will allow us to robustly answer our primary research questions. Of course this does still depend on good quality data return from every hospital - we are not quite home yet!
On the topic of returning data I find myself apologising once again for any inconveniences with the eCRF. I understand most, if not quite all, lead investigators have now received their eCRF access e-mail. Many hospitals have requested additional user profiles and we are grateful to Brigitte and Sandrine at ESA who have been working very long days to set up the eCRF and create the user profiles. We can include up to three eCRF profiles per hospital. If you would like to add investigators then your hospital lead investigator can request these by e-mail to firstname.lastname@example.org listing the family name, given name and e-mail address of the additional user(s).
Some of you who collect creatinine and bilirubin data in units of mg/dL may have noticed a problem with the 24 and 48 hour pages of the critical care CRF. In some cases there have been problems saving the data page because the system does not accept the creatinine and / or bilirubin data even when these are in the normal range. The problem only seems to happen when data are entered in units of mg/dL (not micromol/L)and does not seem to affect every nation. I have asked the company that built the eCRF to correct this error immediately. If the problem has affected you could you let me know? In the mean time, could I ask you to double check that your critical care eCRF data has saved correctly. You may avoid the problem by entering creatinine and bilirubin data in micromol/L. However, my advice would be to wait until we have corrected the error before uploading your critical care data - I hope this will happen on monday.
Update 07 April Study Day 4
Dear EuSOS investigators,
Many thanks for your feedback following my e-mail yesterday. I must apologise as it seems many lead investigators have not received eCRF access e-mails. I have checked with the team at ESA who have been working hard for us to set this up. The news is that all the e-mails have been sent so the problem seems to be either incorrect e-mail addresses or hospital junk mail settings.
If you are a lead investigator at your hospital and you have not received your eCRF username & password e-mail could you take the following steps:
1) Check your junk mail / spam folder
2) Check none of the other investigators at your hospital have received this
3) If still no result then ESA will need to reset your password. Please request this in an e-mail to email@example.com using the subject title PLEASE RESEND PASSWORD. Give your family name, given name and email address. ESA will then resend your username and password by e-mail.
We can include up to three eCRF profiles per hospital. If you would like to add a maximum of two additional investigators then the hospital lead investigator must send an e-mail to firstname.lastname@example.org listing the family name, given name and email addresses of the additional users. My team will then collate these requests and send them on to ESA (this helps to share the workload).
Additional Q &A:
Q: What do I answer for coma score if my patient is intubated?
A: Please enter the ACTUAL coma score. If the patient cannot speak because they are intubated then this will be one for the coma score voice domain.
Q: My patient arrived in critical care on a metaraminol infusion. This vasopressor is not listed in the eCRF, what shall I do?
A: We cannot capture this data. We decided to collect data on a selected group of commonly used inotropic agents. We realise that some patients may receive other agents. This can be captured in the yes/no question on the operating room CRF but not in the critical care CRF. This was a pragmatic decision to limit the workload involved in data collection.
I hope everything else is going well. Thanks for your patience with the issue of eCRF access.
The high level of study activity has been well maintained throughout the week and we are very pleased with the general feedback you have given us.
Once again thanks for your hard work and support for EuSOS. Only three more days to go!
Update 06 April Study Day 3
Dear EuSOS Investigators,
Many thanks for your continued contribution to the EuSOS study. If anything it seems your activity has increased during the week and we have already seen a few completed eCRFs on the website. It seems that for most of you, things are going quite smoothly. A few frequent questions:
Q: On the critical care CRF, what do I enter for airway at end of 24 hours if my patient was intubated at admission but extubated before 24 hours?
A: To represent this, please enter airway as 'endotracheal tube' in the first hour but 'Own airway' at 24 hours
Q: If a patient in critical care requires surgery should I include them?
A: If your patient has an eligible procedure then yes, please include them. The time the patient arrives back in critical care then becomes hour 0 for the purposes of the critical care CRF.
Q: I still havent received an eCRF username and password
A: So far, we have only sent these to the lead investigators in each hospital. This is because we have so many more hospitals and investigators taking part than we expected (a very good thing really!). Unfortunately this means our colleagues at ESA have been working very long hours to register you all. If you need to add an investigator at your hospital, your lead investigator will need to contact us at email@example.com. I am not sure at the moment how many additional user we will be able to register but we will have an naswer to this quite soon.
Q: I was disconnected from the EuSOS ID generator website and now there is now an ID number for our hospital which we have not assigned to a patient. Is this a problem?
A: No. We expected that small number of IDs would be generated but not used. As long as there are not a large number of these, this should not cause a problem.
Update 05 April Study Day 2
Many thanks for all your efforts so far this week. We can tell from the various websites that there has been a huge amount of activity on the EuSOS study in the first two days. We have had a lot of positive feedback from across Europe and also a few queries and questions. It seems that in most hospitals, EuSOS has been progressing smoothly.
Perhaps the most common query has been the CRF. We realise that it is frustrating to receive the username and password details quite late in the day. We encountered a number of unexpected challenges in building a site capable of handling data from over 500 hospitals in a very short time period. As a result, we only completed the eCRF on Friday and have circulated access details on monday and tuesday this week. By now every lead investigator should have received two e-mails: the first explaining how to register on the OpenClinica CRF and the second providing a username and password.
Practice eCRF: The practice eCRF has six login names. You will probably find that they do not always work as a very large number of you will be using them this week. Please try a different login name or perhaps access the site outside peak hours. Remember - be careful not to enter real patient data on the practice CRF!
Live eCRF: We do expect very high traffic on the eCRF and have invested a large proportion of our funding in servers to ensure that the eCRF functions smoothly. However, it is still possible that the site will slow down at peak times over the next two weeks. You may also find the eCRF functions better outside office hours. We strongly recommend you upload each patient's data to the eCRF only when it is complete. This is because some fields on the eCRF are mandatory and you may not be able to save the data you have entered.
Many of you have contacted us for advice and support on various aspects of the study. I hope we have been helpful and supportive. If you have any concerns or questions please feel free to get in touch with us. Could I also ask lead investigators to circulate this e-mail to everyone in your local investigating team.
Thanks for all your hard work. Cearly the EuSOS study has caught the imagination throughout Europe and we are confident that the study will be a great success. Once again - this depends purely on the quality of the data you collect and return!
Update 03 April
Dear EuSOS Investigators,
We have now less than 24 hours to go now before the EuSOS cohort week begins. Thanks for all your hard work in preparing for data collection. We can see that a large number of you have been visiting the website, testing the ID generator and viewing the guidance films. We have now added three more short films to YouTube (see below). There are also many resources on the EuSOS website that will help the day to running of EuSOS in your hospital: http://eusos.esicm.org/study-documents/ <http://eusos.esicm.org/study-documents/> . A brief update on some key points:
Please aim to recruit every eligible patient: Only by collecting data on the overall non-cardiac surgical population can we fully understand how standards of peri-operative care and mortality are related. This means completing an Operating Room CRF for every eligible patient. For the minority of patients admitted to Critical Care, complete a Critical Care CRF for the first admission only, regardless of whether this is on the day of surgery or at a later date.
Unique EuSOS patient ID: The unique EuSOS patient ID generator can be accessed from the main EuSOS website. This has now been updated with the final list of EuSOS sites. The ID generator will go live tonight at 21:00 BST. Use the same EuSOS unique patient ID for the Operating Room and Critical Care CRFs for each individual patient. Remember to check you have the correct country and hospital before generating the ID.
eCRF: I know many of you are keen to see the internet based eCRF. Staff at ESA and ESICM headquarters have been working extremely hard to help the OpenClinica company get the system ready for tomorrow. The eCRF has now been transferred to the main servers and we will start circulating username-password combinations tomorrow. We strongly suggest you do not upload any individual patient's data onto the eCRF until it is complete as there are a number of mandatory fields which must be complete before the data can be saved. Although we have invested heavily in server capacity, the eCRF may be slow at peak times. We advise you to upload your data gradually during the weeks after data collection and if possible, use the eCRF outside normal office hours. We will send eCRF log-in details to the lead investigators initially but we can also create user profiles for local investigators.
eCRF practice site: The eCRF practice site is now live and you can access this using the following link https://www.esactn.org/OpenClinica_test <https://www.esactn.org/OpenClinica_test> and any of the usernames below. Please take care not to enter real patient data onto the practice site!
User account TESTUSER1 password = TESTUSER1
User account TESTUSER2 password = TESTUSER2
User account TESTUSER3 password = TESTUSER3
User account TESTUSER4 password = TESTUSER4
User account TESTUSER5 password = TESTUSER5
EuSOS guidance films: We have now uploaded four videos to YouTube: EuSOS study guide, EuSOS ID generator, EuSOS Operating room CRF and EuSOS Critical Care CRF: http://youtu.be/ak3lSR8virs or visit www.youtube.com <http://www.youtube.com/> and search the topic 'EuSOS'.
Your local investigators: we have had a lot of queires from local investigators who were not on our contacts list. Lead investigators, please circulate this e-mail to everyone in your group. If any new investigators have joined your group pease let Marta know at: firstname.lastname@example.org
Remember that EuSOS is only as good as the data you can collect and return to us. Over 500 hospitals have confirmed participation in the EuSOS study. If we can make sure each of your centres returns a good quality dataset then there is no doubt that our findings will have a huge impact. The next seven days will be critical. We are extremely grateful to all of you for investing your time and energy to make the study a success.
Good luck with data collection!
Update March 28th
EuSOS receives the endorsement of the Spanish Society of Intensive Care (SEMICYUC).
Update March 14th. Open letter to all investigators
Dear EuSOS Investigators,
Many thanks for volunteering for the EuSOS study. With 600 hospitals taking part, the study has the potential to produce an international dataset unprecedented in peri-operative care. Given the current shortage of data in this field, the findings could have a massive impact on clinical practice and research in peri-operative medicine in every nation which takes part.
The EuSOS study is only as good as the data we collect and return through the internet based CRF. The quality of data will define both the study and the true impact of the findings. It makes me very proud to see how the project has captured imaginations across Europe. Clearly, there are many of us who believe there is more we can do to improve outcomes for our patients. Ultimately the EuSOS study belongs to all of you which is why we will ensure the contribution of every investigator is publicly recognised.
Soon we can make the EuSOS dream a reality. With only 21 days to go, I am writing now to ask you to give the project your full attention. High profile leadership in each hospital is the single most important factor which will deliver the project. It is vital that we collect and return good quality data in each of your hospitals. To help you we have provided several resources on the EuSOS website including a short film describing some of the study procedures:
At this stage can I ask you to:
1) Visit the website and look at the study resources and documents: http://eusos.esicm.org/study-documents/
2) Make sure that you have a good team of investigators in your hospital
3) Ensure that the relevant clinical staff are aware of the EuSOS study and understand how to support it
4) Return the Local hospital data and ethics confirmation form (mandatory for participation). Your Lead local investigator has or will soon receive this with some of your hospital details inserted including a unique EuSOS hospital ID. A blank version can also be found on the website.
Thanks again for your valuable contribution. We will be in touch again before the study starts.
Rupert Pearse on behalf of the EuSOS Steering Committee
Update March 8th. Open letter to National Coordinators
Update February 22nd
EuSOS receives the endorsement of the Sociedad Española de Anestesiología y Reanimación
Update February 11th
EuSOS receives the endorsement of the Societas Anaesthesiologica Norvegica.
Update February 06th
Things are moving fast now. We have been contacted by over 400 hospitals from 30 countries – more than twice the number we had hoped for. The great news is that the EuSOS data will be extremely powerful but there is a challenge too. Because we have so many hospitals taking part we have to work much harder in the time available to make sure everything is in place for April 4th. We need your help with this:
Site information forms: every hospital needs to complete a site information form (one hospital : one form). Please nominate a local co-ordinator as the first person to contact. All investigators will be listed as members of the EuSOS study group.
Ethics / IRB and other regulatory approval: Most countries have either completed this process or are nearly there. However, many of you will need to complete a local regulatory process too. Do you know what paperwork you need in your hospital? If not, please check – your national co-ordinator will be able to advice you.
Frequently asked questions: There are many! We have put a sheet together and placed this on the website. This has been updated today and we will make more updates in the next few weeks. You may want to check this every week or so. Please let us know if you have any questions we didn’t cover.
Internet based data portal: This is how we will gather the data you collect. We are running a little behind schedule but we are still confident we can have this ready in time. We will soon be sending usernames and passwords out.
Communication: there will be quite a few e-mails coming through in the next few weeks. It helps enormously if you can reply quickly. We have taken on extra staff to deal with everything but we still need your help to get the job done.
Remember, the operating room data sheet should be completed for every eligible patient who undergoes surgery in the seven day study period. We then follow these patients until hospital discharge (for a maximum of sixty days).
Thanks again for your contribution to the EuSOS study. If we do our job well we will have a far larger data set than we hoped for. To be successful, we still need to collect good quality data and return this through the internet based data portal.
Update January 21st
EuSOS has received the endorsement of La società italiana di anestesia analgesia rianimazione e terapia intensiva
Update December 28th
EuSOS has received the endorsement of Deutsche Gesellschaft für Anästhesiologie und Intensivmedizin (DGAI)
Update December 22nd
EuSOS has been endorsed by the Sociedade Portuguesa de Cuidados Intensivos (SPCI) and the Sociedade Portuguesa de Anestesiologia (SPA).
Update December 17th
Seasons greetings and thanks for all your work in securing ethics and regulatory approvals in your nations. We are now receiving a steady stream of site information forms which will help us to communicate effectively with each hospital and also to publicly acknowledge the work of every member of the EuSOS study group. We need to continue this so we can ensure that everything is in place in time for the data collection week in April.
We have now finalised the EuSOS data case record forms (CRFs) and these will be available on the website shortly. This will give you a clear idea of the data we need to collect during the study. We are making progress with the internet based data portal. Although this will not be ready as early as we had hoped, we are confident the site will be tested and working in good time for the study week.
One important issue has come to light in your correspondence. We have received a number of queries about which patients to recruit into EuSOS. Many of you have explained that you did not realise that we aim to recruit every patient who fulfils the EuSOS inclusion criteria. In order to fully understand the non-cardiac surgery population, we need data on every patient because many will not be admitted to critical care even if indicated due to the limited number of critical care beds in some nations. This will vary from nation to nation and we want to compare this important factor between hospitals and nations. We need to make sure that all members of the study group understand that the operating room data sheet should be completed for every eligible patient who undergoes surgery in the seven day study period. We have kept the operating room CRF very short to ensure this is feasible. Apologies if this was not clear and thanks to all of you who have pointed out this important mis-understanding. Please get in touch via Mail if you need to discuss this further.
Once again, a big thank-you to all of you for your hard work on the EuSOS study. We are now very confident that we will capture data on a very large number of patients. If successful EuSOS will be one of the most important epidemiological studies conducted so far in peri-operative care.
Update 05 December 2010
Eusos receives the endorsement of the Romanian Society of Anesthesiology and Intensive Care.
Update 01 December 2010
Eusos receives the endorsement of the Belgian Society of Intensive Care Medicine.
Update 30 November 2010
The EuSOS study group continues to grow. With the recent addition of Bulgaria, Croatia and Serbia we now have thirty nations participating in the study with still a few more we hope will join.
At present our focus is on confirming the necessary paperwork and approvals are in place for each hospital so data can be collected during the April study week. We now have Research ethics approval for EuSOS in a number of countries including the United Kingdom. Some nations need a copy of the UK ethics approval as this is where the chief investigator is based. We have therefore included this in the study documents folder on the website.
One important task we need your help with is the site information forms. We need each site to complete the information form so we have a list of investigators and a primary contact in every centre. This is important for research governance but also so we can list your names as members of the study group. The site information form is now available in the study documents folder.
Update 29 November 2010
EuSOS recieves the endorsement of the College of Anaesthetists of Ireland and the Intensive Care Society of UK.
UK ethics approval gained for EuSOS.
Update 26 November 2010
EuSOS adopted as ESICM ECCRN Trial Group study.
Update 25 November 2010
EuSOS recieves the endorsement of the Czech society of Anaesthesiology and Intensive Care
Update 22 November 2010
EuSOS recieves the endorsement of the Intensive Care Society of Ireland.
Update 19 November 2010
In this latest update of our progress, we are delighted to tell you that we now have 28 nations participating in the EuSOS study with a few more we hope may join. We now expect to have over 200 hospitals taking part across Europe and the investigator team has been confirmed in over half of these. Meanwhile our national co-ordinators have been working hard on securing the necessary ethics / regulatory approvals. These approvals have now been confirmed in ten countries and are under review by the relevant committees in most of the remainder.
EuSOS predictions: We are now extremely well placed to meet or even exceed our recruitment target of 20,000 patients. Equally as important, we have enough hospitals in most nations to ensure that the national datasets accurately represent the respective countries. Provided we translate this potential into data returned, we will have a large enough patient sample to answer all our research questions and be able to make valuable comparisons between healthcare systems.
Study week: The EuSOS cohort week has now been confirmed as April 4th to April 11th 2011. Bar a few exclusions (see protocol) we will collect data on all adult patients who undergo in-patient non-cardiac surgery during this week. We will then follow them up until hospital discharge for critical care admission, hospital stay and survival. Although we have a few holidays to look forward to between now and then, April is only a short time away so we need to make sure everything is in place in each of our hospitals. In particular we must ensure we have local permission and the support of our colleagues in anaesthesia and critical care to perform the data collection. These matters can take longer than expected. Mmost of you have this well in hand but if not, now is the time to start!
Data collection We have had a few delays in building our internet based data collection system. However, we are still on course to have this built and tested in time for late April when most of the data will be uploaded. I hope to have a training site available for you early in 2011 so you can learn how to use this system. EuSOS will only be as good as the quality of the data collected and returned to us and it is worth a reminding ourselves of the importance of preparing a strong team in each hospital who will ensure good data collection and data entry onto the website.
Thank-you! More than anything else, the EuSOS study will be about the contributions of local investigators. We are slowly compiling a list of hospitals and investigators and when this is complete we will place this on the EuSOS website so your contribution is publicly acknowledged. This is one of the reasons we need you to complete the site information form and return it to us. We are very grateful for all the work you have done so far and look forward to realising the massive potential of the EuSOS study group in April next year!
The EuSOS Steering Committee