Who can participate?
- We would welcome as many hospitals as possible from whole Europe.
- Every included and completely documented patient will be included in the data analysis
Is there a minimum patient number, which should be included into the trial?
No! Every included patient is valuable for the POSE study. Of course, we would appreciate if the centers do not recruit only one patient
Will my work be recognized?
- Each participating centre including at least one patient may designate a collaborator that will be mentioned in the POSE-Study group in the publications. All collaborators will be trackable via PubMed. The number of mentioned collaborators will depend on the number of enrolled patients, who had their surgery within the self-selected timeframe of 30 days. According to the new publication policy of 22th February 2019 (please see here ) that means:
- 1 included and documented patient => 1 collaborator
- 25 included and documented patients => 2 collaborators
- 48 included and documented patients => 3 collaborators
- 72 included and documented patients => 4 collaborators
- 96 included and documented patients => 5 collaborators
- 120 included and documented patients => 6 collaborators
- 143 included and documented patients => 7 collaborators
- Top enrolling sites with ≥71 included and completely documented patients can designate one or more Co-authors in addition to the previous paragraph, according to the publication policy here.
- 71 included and documented patients => 1 Co-Author (+ the collaborators above)
- 143 included and documented patients => 2 Co-Authors (+ the collaborators above)
- In addition, we will provide to each person, who has worked in the POSE-Study according to the study delegation log, a certificate to verify their contribution to the POSE-Study.
How will POSE work?
Each hospital will collect data on every eligible patient who has surgery or intervention with anaesthesia care (performed by an anaesthetist) within the selected inclusion period of 30 days. Follow up data will be collected on day 30 after surgery/intervention via hospital data base and patient contact (either via visit on ward, if the patient is still in hospital, or via telephone call).
Which patients should be included?
- All consecutive patients ≥ 80 years of age, undergoing surgical and non-surgical interventions (e.g. radiological, neuroradiological, cardiological, gastroenterological) with anaesthesia care (performed by an anaesthetist) within the self-selected inclusion period of 30 days
- Elective and emergency procedures should be included
- In-patient and out-patient procedures should be included
Which procedures should be excluded?
- All diagnostic procedures with anaesthesia care, but without any kind of intervention or surgery like e.g. diagnostical MRI or CT scan in sedation.
- All solely anaesthesiological interventions like e.g. insertion of a central venous catheter or application of regional anaesthesia against pain, without any other intervention.
- Or procedures, which are only done in local anaesthesia or “stand by” anaesthesia.
Should we include every patient, who fits the inclusion criteria and doesn`t have exclusion criteria?
- Yes, you should include all consecutive patients during the recruitment period for your centre.
- Depending on your ethical approval/regulatory approval you should also include legally incompetent patients, to avoid selection bias. It is really important that we collect also data for this vulnerable population, which is often excluded from studies.
Which data should be collected?
You can find all data, to be collected in the Case Report Form Appendix 2 POSE Case report form version 1.4 of the Study protocol, which you should print out for each patient. Data will be collected on this paper and then entered onto a secure website “Open Clinica”. (The link to this website will be made available soon).
When does the recruitment period of 30 days start for a centre?
Each Principle Investigator will choose 30 consecutive days until 2nd December 2018. The Principle Investigator has to inform the POSE Study team at least 1 week before the planned study start in his/her centre.
Does the recruitment period of 30 days have to start at the first day of a month?
No! You can choose any day in a month. E.g. if you start on the 8thNov 2017, than your recruitment period will last from the 8.11.2017 00:00h local time until 7.12.2017 24:00h local time.
What is, if a patient has surgery twice during the recruitment period?
Patients should only be included in the study once. Repeated surgery should only be included if the first procedure took place before your POSE study month began.
Can we also participate, if the recruitment period has already started?
Yes, of course! The total study period will last until 31.December 2018. All centers, which have received their ethical approval to start the study until 2nd December 2018, can participate.
How is the Hospital length of stay after intervention until the follow-up day defined?
It is including the day of intervention, but excluding the discharge day. If the patient is still in hospital on the Follow-up day 30 after intervention, then you have to enter 31 days duration into the database. You do not have to follow-up the patient longer than 30 days after intervention.
If the patient was discharged after surgery e.g. on postoperative day 5 and re-admitted to hospital on postoperative day 8, you do not have to sum up the hospital stays. Only the first hospital stay has to be counted.
How is the total ICU length of stay after intervention defined?
It is including the day of ICU admission, but excluding the discharge day from ICU. If the patient is continously on the ICU since the intervention, and still on ICU on the Follow-up day 30, please enter 31 days into the database.
If the patient is several times admitted to the ICU within the 30 days Follow-up period, please add all stays. Please also apply the rule to count the day of admission but to exclude the day of discharge.
How are the start and the end of anaesthesia defined for spinal anaesthesia?
Start=start of application of spinal anaesthesia End = removal of the monitoring ( e.g. ecg, blood pressure monitoring, oxygen saturation measurement etc.) of the patient in the operating room.
How is the end of anaesthesia defined, if the patient is transferred intubated to the intensive care unit?
End = handover of the patient to the intensive care unit team.
How to verify the outcome reporting (Serious cardiac or pulmonary complication, Stroke, Acute kidney injury) by the patient on postoperative day 30?
As stated in the study protocol: “After hospital discharge, events will only be defined as present if they lead to hospital re-admission or death.” That means, if the patient reports any of these complications, we would like to encourage you to contact the respective hospital or family physician to verify the statement.
If we have used another version (according to local regulatory standards) of the safe-surgery-checklist than the WHO safe surgery checklist, should we tick yes to this question in visit 2?
Yes, please tick “yes” to the question: WHO-surgical checklist used?
Does Extubation in Visit 2 mean the same as removal of laryngeal mask airway?
Yes, Extubation at the end of intervention in visit 2 also refers to the removal of laryngeal mask airway.
Re-admission to hospital and hospital length of stay
If the patient was re-admitted to the hospital => Please count for the “hospital length of stay after intervention until follow-up” only the first hospital stay.