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: http://www.asos.org.za/documents/Screening%20Record%20Guide.pdf

When recruiting patients, do we recruit only high-risk patients?

Recruitment includes ALL surgical patients 18 years or older who are having surgery and spending the night in hospital. This means BOTH low- and high-risk patients are recruited. As a reminder, all eligible patients need to be added to the screening log. However, although all surgical patients are recruited in the intervention arm (i.e. both low and high-risk patients), it is only the high risk patients which will receive the ASOS-2 intervention of increased postoperative surveillance.

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

  • Fill out a new CRF?

    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.


  • Reclassify them as high-risk?
    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.

If a patient was admitted to an Intensive Care Unit (ICU) rather than a High Care Unit (HCU), how do I indicate this?

You indicate that the patient was admitted to a higher care ward and the relevant post-operative care given.

If a surgical division/department does not agree to participation in the Trial, how do I indicate these eligible patients who are not included in the Trial? Must I include these patients in the screening log? For example, the urology department of a major hospital does not want to partake in ASOS-2, and twenty eligible urology patients had operations in the recruitment period. Are these 20 patients included in the screening log even though they are not in the trial and not for follow-up?

Yes, these patients must be included in the screening log. The screening log is meant to include ALL eligible patients. Therefore a screening log must report all eligible patients, including; i) patients who refuse participation and ii) patients who are not part of the trial because of a division or department’s decision to not participate in ASOS-2. Thus, there will be more eligible patients than included patients – this is very important information needed for the study analysis.

Do we include/recruit patients coming for Caesarean Section into the Trial?

Yes, these patients are definitely eligible for recruitment provided they are 18 years or older and spend the night after their Caesarean delivery admitted in hospital.

How do we deal with a patient and potential complications if a patient has ≥ 1 procedure during the 30 days of the Trial follow-up?

For example of this scenario may be the following. A patient is admitted for a minor procedure and is appropriately enrolled. The patient will not be discharged before a second (major) procedure that will be done within 30 days of initial procedure. I am aware that they will not be re-enrolled into the trial, but what if in the 30 days they develop complications following the second (major) procedure but unrelated to the minor procedure? Do we classify these as complications even though they are not related to the primary procedure at enrolment? Any complication during the hospital admission is recorded. Therefore, even if a complication is secondary to a later second operation, provided it is all during the same admission of the index operation that got the patient into the trial, this must be reported on the case report form (CRF).

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 do I fill out on the CRF if a patient dies on the table? Do they qualify?

Firstly, the patient is included in the study i.e. they qualify. Secondly, for the CRF, mark no for all other complications on day 0 and mark no for all post-operative interventions on day 0.

On the CRF, there is a request for a “photo of the clinical notes” of a deceased patient. Is this ethical?

In any clinical trial there has to be auditing of the primary outcome. As mortality is the primary outcome, we are asking for a photo of a 'de-identified' clinical note which verifies the death of the patient. This is an accepted ethical request in any clinical trial. A copy of this clinical note should be kept at the trial site in the patient's trial folder. Should the need arise to conduct an audit of a site, then these data will be available for verification.

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.

What do I fill in on the CRF if a patient is operated on at my site, and transferred immediately after surgery for further care? How do I document post-operative complications?

If this occurs, you document no to all post-operative complication questions and tick alive and discharged to another facility. You will not follow-up these patients. Additionally, they will not be eligible for enrolment at the transfer facility.

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.

How do we define urgency?

  • Elective: not immediately life-saving; planned within months or weeks.
  • Urgent: planned surgery within hours or days of the decision to operate.
  • Emergency: as soon as possible; no delay to plan care; ideally within 24 hours.

How would I define spinal surgery? Is it neurosurgery or orthopaedics?

Surgery done on the cervical spinal cord is classified as neurosurgery. Surgery on the thoracic and lumbar spine is defined as orthopaedic surgery.

What surgeries are classified as neurosurgery?

Neurosurgical procedures are defined as involving the brain and cervical spinal cord.

What ASA status to we give pregnant patients?

Pregnant patients are classified at a minimum of ASA status 2.

How do we classify endovascular stents (for example for aortic aneurysm) under general anaesthesia/sedation?

This is classified as intermediate as per the European Society of Cardiology and the European Society of Anaesthesiology.

Do I need to change the classification of a minor surgery to intermediate if the procedure lasts for more than 30 minutes? The ASOS-2 protocol states minor surgery lasts less than 30 minutes.

If the procedure is significantly longer, you can use your discretion and mark it as intermediate.

How do we classify surgery for an ectopic pregnancy?

Please classify these patients as emergency, and the indication for surgery as ‘non-communicable disease’.

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.

What do I fill in on the CRF if a patient is operated on at my site, and transferred immediately after surgery for further care? How do I document post-operative complications?

If this occurs, you document no to all post-operative complication questions and tick alive and discharged to another facility. You will not follow-up these patients. Additionally, they will not be eligible for enrolment at the transfer facility.

If a patient is admitted to the general ward, but is later admitted to a higher care ward/ICU, what do I do?

Please mark this intervention as higher card ward admission.

Administrative Questions

My hospital has been randomised into the control/intervention arm of the ASOS-2 Trial, however, we can no longer participate. How do we proceed?

There are many benefits to participating in the ASOS-2 Trial. These include helping improves surgical outcomes in Africa. It also includes being part of a larger research network across Africa, which through its size can make meaningful contributions to improving public health in Africa. Furthermore, participation in ASOS-2 will result in a peer-review publication in a high-impact journal, which will be citable in your CV (curriculum vitae), as a collaborator. Please note that randomisation cannot be undone; and so, once a hospital is randomised it is very important that the hospital remains in the trial, and recruits and participates in the trial. Non participation will unfortunately compromise the whole trial, and the work done by the other 650 sites across Africa. Please note, that once a hospital is randomised it is in the ASOS-2 Trial, as per the intention to treat principle. In order to assist you in ensuring you participation in ASOS-2, we will have to work on a new recruitment date for your hospital that should be more convenient for your site. Please let us know if there are specific obstacles which are currently preventing your site from recruiting patients.    Remember that the trial is specifically designed for resource limited environments, so sites like yours are particularly appropriate for participation in the ASOS-2 Trial. Please remember that this trial is essentially unfunded, but the design specifically for a resource limited environment, should result in a low impact on resources at your site.

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.

Why is the screening tool important? Do I have to complete it?

The screening tool is important and as it gives an up to date log of how many patients have been recruited and whether the CRFs are completed. You have to complete the log as your site will only be closed after it is accurately finished. Please review the ASOS-2 Screening Tool for reference: http://www.asos.org.za/documents/Screening%20Record%20Guide.pdf

Who do I enter into the screening tool?

You only enter eligible patients into the screening tool. Please review the ASOS-2 Screening Tool for reference: http://www.asos.org.za/documents/Screening%20Record%20Guide.pdf

How is the ASOS-2 patient ID number generated? Do I need to put in the patient’s local hospital number?

REDCap will generate the ASOS-2 patient ID number; use this ASOS-2 patient ID number to identify the patient for further queries/follow-up. The ASOS-2 patient ID number should be transcribed onto the paper CRF. To clarify, you do not enter the patient’s local hospital number in REDCap. The patient’s local hospital number is only on the paper CRF kept at the local hospital site, which will allow for tracking patients for any data queries.

What do I do with the CRF? Does our team need to print it, scan it, upload it etc?

A physical record of the CRFs is a requirement for the Trial. The physical CRFs are to be kept at your site as this allows us to query data if necessary before closing your hospitals database. The data from the CRF is uploaded onto REDCap for analysis.

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.

On the CRF, there is a request for a “photo of the clinical notes” of a deceased patient. Is this ethical?

In any clinical trial there has to be auditing of the primary outcome. As mortality is the primary outcome, we are asking for a photo of a 'de-identified' clinical note which verifies the death of the patient. This is an accepted ethical request in any clinical trial. A copy of this clinical note should be kept at the trial site in the patient's trial folder. Should the need arise to conduct an audit of a site, then these data will be available for verification.

'Intervention Arm’ Specific Questions

When recruiting patients in the intervention arm, do we recruit only high-risk patients?

Recruitment includes ALL surgical patients 18 years or older who are having surgery and spending the night in hospital. This means BOTH low- and high-risk patients are recruited. As a reminder, all eligible patients need to be added to the screening log. However, although all surgical patients are recruited in the intervention arm (i.e. both low and high-risk patients), it is only the high risk patients which will receive the ASOS-2 intervention of increased postoperative surveillance. 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.

There is some confusion about who we need to include in the Trial… do we include only high-risk patients (score of ≥10 on the ASOS Surgical Risk Calculator) or do we included all surgical patients?

ALL patients 18 years and older spending the night following surgery in hospital need to be included in the trial. The intervention however is only given to the high-risk patients.

How long do we continue increased surveillance? The CRF only has 4+ days, so do we stop at 4 days or do we continue with increased surveillance?

We suggest continuing increased postoperative surveillance for high risk patients for as long as possible. It is dependent on how feasible it is with potentially additional new high-risk patients each day after surgery also requiring the intervention of increased postoperative surveillance. Ideally, continue increased postoperative surveillance for as long as possible, as the principle is to identify and manage complications early, and thereby decrease mortality. Please note that the median stay for patients who developed complications in ASOS-1 was 6 days.

'Control Arm' Specific Questions

For the control arm of the study, the CRF does not include parameters for high-risk patients and postoperative surveillance . Are we excluding data on postoperative care in the control group?

In the control CRF we collect data, which will allow us to compare high-risk patients between the control and intervention arms. However, as this is the standard of care arm, we have left the determination of high-risk to the usual practice of the clinical providers. We do also collect data on postoperative care, in the following questions on the CRF:
Indicate postoperative care given:
Higher care ward  No  Yes
Increased nursing observations  No  Yes
Assigned a bed in view of nurses’ station  No  Yes
Family with patient in ward  No  Yes

However, the postoperative care information that is collected is not as detailed as in the intervention arm. The reason for this, is that in the intervention arm we also want to know how much (i.e. the dose) of increased postoperative care that was given.

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.

There is some confusion about who we need to include in the Trial… do we include only high-risk patients (score of ≥10 on the ASOS Surgical Risk Calculator) or do we included all surgical patients?

ALL patients 18 years and older spending the night following surgery in hospital need to be included in the trial. The intervention however is only given to the high-risk patients.

How long do we continue increased surveillance? The CRF only has 4+ days, so do we stop at 4 days or do we continue with increased surveillance?

We suggest continuing increased postoperative surveillance for high risk patients for as long as possible. It is dependent on how feasible it is with potentially additional new high-risk patients each day after surgery also requiring the intervention of increased postoperative surveillance. Ideally, continue increased postoperative surveillance for as long as possible, as the principle is to identify and manage complications early, and thereby decrease mortality. Please note that the median stay for patients who developed complications in ASOS-1 was 6 days.