FAQs

Enrolment / Recruitment Questions

When do we end recruitment?

The recruitment process works in week cycles. Recruitment stops on:
  1. The Monday morning after the week in which 100 patients in total were enrolled i.e. if you enrolled your 100th patient on the Friday, you continue recruiting/enrolling until the Monday morning. If you have not recruited a 100 patients after the first week, you will continue to recruit. A hospital will stop recruiting on the Monday, of the week in which they have exceeded 100 enrolled patients. Please note, this will mean you will potentially recruit more than 100 patients as the recruitment only stops on the Monday following recruitment of a 100 patients.
  2. If your site has not enrolled 100 patients after 4 weeks of recruiting, you will stop recruiting on the Monday at the end of four weeks.

Please review the ASOS-2 Screening Tool for reference.

Do we need 100 high-risk patients or 100 patients overall?

Recruitment includes all surgical patients 18 years or older, who are having surgery and spending the night in hospital. Therefore, you need to include 100 patients overall.

If an enrolled patient comes for repeat surgery, do we need to:

  1. Fill out a new CRF?
  2. No, you do not need to fill out a new CRF as the patient is already enrolled. You will need to log any new postoperative complications defined as ‘severe complications’ as appropriate. The definition of a ‘severe’ complication is on the back of the case report form (CRF), and in the ‘Definitions document’ in the ASOS-2 Protocol.
  3. Reclassify them as high-risk?
  4. No, they will remain classified as they were on enrolment, however, new ‘severe’ postoperative complications should be logged and appropriate medical management should be instituted. The definition of a ‘severe’ complication is on the back of the case report form (CRF), and in the ‘Definitions document’ in the ASOS-2 Protocol.

If a patient who has been admitted and had surgery prior to the recruitment period, and now gets booked for a new surgical intervention during the recruitment period, what do we do?

You enrol the patient at the time of the new surgical intervention and only log new complications. If the patient had existing complications, these will only be logged if they worsen, and they fulfil the definition of a ‘severe’ complication. The definition of a ‘severe’ complication is on the back of the case report form (CRF), and in the ‘Definitions document’ in the ASOS-2 Protocol.

If a patient was discharged, and then comes back for readmission with/without a surgical complication, what do we do?

The end-point is in-hospital outcomes, so we do not collect complications following discharge or at hospital readmission, nor do we collect outcomes or complications from a hospital the patient has been discharged to. The only exclusion for enrolment/recruitment/participation is prior enrolment/recruitment in ASOS-2.

If a patient comes from another recruitment hospital to our site for further care, do we recruit them?

No, we do not recruit them, as they have already been recruited. Prior recruitment is the only exclusion criterion for ASOS-2 enrolment.

Are sedations included in the study?

Sedations for whatever intervention (endoscopies, uterine evacuations etc) are included only if they are admitted overnight.

Are day cases included? If a patient was admitted pre-operatively and then discharged the same day, are they included?

No, day cases and same day admission-discharge cases are excluded. If a day case, subsequently requires admission for whatever reason, they will only then be recruited/enrolled/included in ASOS-2.

Discharge/Death Questions

What happens in the event of a death?

A death will be recorded as per the CRF. A de-identified copy of the notes confirming the death will need to be uploaded on the REDCap database. To maintain anonymity, please cover any identifying data e.g. name, address etc. Please remember to keep a copy of these notes at your site, in the patient’s ASOS-2 Trial file.

What happens to a case that is transferred to another institution?

The patient will be recorded as ‘alive and discharged’. Then it is important to mark whether or not the patient was ‘alive and discharged and transferred to another facility for higher care.’ Further follow-up is not required by your site.

If a patient was discharged, and then comes back for readmission with/without a surgical complication, what do we do?

The trial end-point is hospital discharge, so we do not collect complications post-discharge, or at hospital readmission, nor do we collect details/complications from a hospital the patient has been discharged to. The only exclusion for enrolment/recruitment/participation is prior enrolment/recruitment in ASOS-2.

Grading/Classification Questions

What grade of surgery is a Caesarean Section?

Caesarean Section is classified as intermediate risk. For a full list of surgery classifications, please refer to the protocol on the ASOS-2 website, https://www.asos.org.za/index.php/study-documents

How do we classify/ grade thoracoscopy for biopsy?

Thoracoscopy is classified as intermediate risk. For a full list of surgery classifications, please refer to the protocol on the ASOS-2 website, https://www.asos.org.za/index.php/study-documents

What kind of surgical procedure category are burns cases?

Burns cases are classified as plastic surgery.

What grade of surgery is an amputation?

An amputation is major surgery. For a full list of surgery classifications, please refer to the protocol on the ASOS-2 website, https://www.asos.org.za/index.php/study-documents

What type of surgical procedure category does “amputation” fall under?

It depends on the indication for the amputation, e.g. peripheral vascular disease – vascular, cancer – orthopaedics, traumatic leg injury -orthopaedics

If a patient has an anaesthetic (general/neuraxial/sedation), but the surgical procedure is cancelled on the table, how do we classify this patient? Do we enrol this patient?

The patient will be enrolled, if there was an incision and the patient stays overnight in the hospital. The aborted procedure will be classified as minor surgery.

Postoperative Complications Questions

If the patient has AKI (acute kidney injury) on admission, does this count as a postoperative complication?

No, as this was present before the postoperative period. The complications recorded on the CRF need to occur postoperatively. If the AKI worsens to the point that it is considered ‘severe’, it can then be logged as a complication on the day it was diagnosed as ‘severe’. The definition of a ‘severe’ complication is on the back of the case report form (CRF), and in the ‘Definitions document’ in the ASOS-2 Protocol.

If the patient has pneumonia/lower respiratory tract infection (LRTI) on arrival in theatre, is this classified as a postoperative complication?

No, as this was present before the postoperative period. The complications recorded on the CRF need to occur postoperatively. If the pneumonia worsens to the point that it is considered ‘severe’, it can then be logged as a complication on the day it was diagnosed as ‘severe’. The definition of a ‘severe’ complication is on the back of the case report form (CRF), and in the ‘Definitions document’ in the ASOS-2 Protocol.

If the patient has sepsis on arrival in OT, is this recorded as a complication?

No, as this did not occur postoperatively. The complications recorded need to occur postoperatively. e.g. surgical site infection postoperatively, pneumonia in the postoperative period. Additionally, if the pre-operative complication worsens, the complication can be logged on the day it worsened, provided it is defined as a severe complication as per the ASOS-2 Trial definitions document. The definition of a ‘severe’ complication is on the back of the case report form (CRF), and in the ‘Definitions document’ in the ASOS-2 Protocol.

Any question relating to complications identified pre-operatively…

If a complication is present pre-operatively, it is not logged as a postoperative complication. If the complication worsens postoperatively, it can then be logged as a complication, provided it is defined as a severe complication as per the ASOS-2 definitions document, noting the day on which the complication became ‘severe’. The definition of a ‘severe’ complication is on the back of the case report form (CRF), and in the ‘Definitions document’ in the ASOS-2 Protocol.

If the patient develops a complication on the day of the surgery, what day is this?

The day of the surgery is Day 0. The day after surgery is Day 1, the subsequent day is Day 2 etc.

Administrative Questions

How can we get new people registered as investigators for ASOS-2?

Anyone who wants to be or is involved in ASOS-2 can register as an investigator at: https://www.asos.org.za/index.php/registration Remember anyone who is registered as an investigator, will also be listed as a collaborator on PubMed with the Trial publication, which means it can be cited as a paper by the investigator. We, therefore, encourage all investigators at every site to register online.

Where do I find all the up-to-date ASOS-2 documents – study documents/CRF/protocol/outcomes definition/broadcast guide etc?

The updated documents will have been forwarded to you by the ASOS-2 team. They are also available on the ASOS-2 website: https://www.asos.org.za/index.php/study-documents Please ensure that you are using version 4 of the case record form (CRF). If you are not sure, please check that it is the same as the CRF on the website.

Ethical concerns/questions

What happens if a patient does not want to be included in the study?

Any patient can opt-out of the study at any time should they wish to do so.

How do we ensure ethical practice with the waiver of consent?

Please ensure all broadcast documentation is clearly displayed. These documents can be modified to local applicability. Additionally, any patient can opt-out of the study at any time should they wish to do so.

'Intervention Arm’ Specific Questions

What does ‘increased nursing observations’ mean?

This means any increase in frequency of nursing observations when compared to the normal practice/ frequency of nursing observations on the ward e.g. if nursing observations are usually 4 hourly on the ward, then 2 hourly observations would be considered ‘increased nursing observations’.

My increased observation area is now full, where do I put the new patients requiring the intervention?

The philosophy of the trial is to do as many ‘increased postoperative surveillance’ interventions, for as long as possible. If it requires moving stable high-risk patients who have been receiving ‘increased postoperative surveillance’ from a ‘higher care ward/area’ to make space for a new high-risk patients needing the intervention, this is acceptable. We would encourage you to continue to provide other ‘increased postoperative surveillance’ interventions to the patient who has been moved from the ‘higher care ward/area’ e.g. increased nursing observations, putting the patient in a bed in view of the nurses station in the ward.