Q. Adding new web tool users - permission levels
A. When a new log-in is set up for someone to use the web tool, there are three different permission levels available:
Site administrators - have full access to the web tool with the ability to view site data and reports, input and export patient data, and unlock any previously locked patient records in cases where the data needs to be amended. Site administrators are also able to set up log-ins for colleagues in their hospital to add capacity to their local team as and when needed.
Site users - are able to view site data and reports, as well as input and export patient data. They are not able to unlock records or add new users.
Site readers - are able to view site data and reports only.
Local teams are able to have as many site administrators, site users or site readers in their teams as they wish.
Q. Adding new webtool users
Q. Can patients be recruited into the study more than once (if they have a second elective procedure)?
No - a patient can only be registered on the database once.
Q. Data entry - SOP
A. We have provided a Standard Operating Procedures (SOP) document which should answer most data entry questions. You can access the SOP on the "Study Documents" page of the website.
Q. Data entry/follow up - Can I still input 6/12 month questionnaire data even if a record is locked?
A. Patient records should be locked as soon as all sections (1-7) of the clinical data are complete and show up as green in the status bar. Even though the record is locked, this will not prevent you from entering the record at the 6/12 month stage to input the follow up questionnaire data as these questionnaires operate under a separate locking system. Once the 6/12 month questionnaire data is inputted, each questionnaire will need to be locked individually to submit the data to the central PQIP team.
Q. Data entry/follow up - How do I record that a patient has passed away?
A. If a patient passes away while they are admitted for surgery, this can be recorded in section 7 of the CRF on the web tool. However, if a patient passes away after they have been discharged from hospital, you should leave the CRF as it is and record it in the 6 and/or 12 month questionnaires for the patient on the web tool, using the drop down box on the first page of each questionnaire. This will prevent the web tool from sending any questionnaire follow up reminders for the patient.
Q. Data entry/follow-up - How is data being collected?
Clinical information will be directly entered onto electronic Case
Report Forms within the PQIP webtool. Pre- and post-operative patient
questionnaires will be completed on paper CRFs and then entered onto the
webtool by the local research team.
Q. Data entry/follow-up - How will data be reported back?
Real-time feedback of key metrics will be available on the PQIP dashboard
In addition we will send quarterly summaries of your data to the surgery, anaesthesia, management and improvement leads.
Q. Data entry/follow-up - In what time frame should I collect the 6/12 month follow up questionnaire data?
A. For the 6 and 12 month questionnaire follow up telephone calls, we advise that the data should be collected from the patient within 30 days (+/-) of the due date. We provide telephone follow up guide scripts on the Study Documents page to assist you to make the calls.
Q. Data entry/follow-up - What if the patient does not undergo the procedure they were recruited for?
A. If the patient was recruited for an eligible procedure but this changed to an ineligible procedure before the patient reached theatre, the patient should be withdrawn from the study. This can be recorded in section 7 of the CRF in the web tool.
If the patient was recruited for an eligible procedure that changed to an ineligible procedure after the patient reached theatre, the patient should remain in the study and all follow-up data collected as normal.
Q. Data entry/follow-up - What is the approximate time requirement for data entry for one patient?
The most time efficient (and accurate) way of entering data will be to do this prospectively as the patient transits through the hospital.
The person taking consent should immediately open a case report form on the webtool.
Data can then be entered for each patient by any member of your hospital team who has a login. Most pre- and intra-op data can be entered by the person taking consent or the anaesthesia and surgery team during/immediately after surgery.
Patients will be required to complete questionnaires before surgery and one days 1 and 3 after.
Clinicians/research teams will need to enter data on the day of surgery, in the recovery ward, and then on day 7 postop (if the patient is still in hospital) and on the day of hospital discharge.
Q. Data entry/follow-up - Who can input data?
Any member of the local clinical or research team who has a personal login to the web-tool.
Q. Data entry/follow-up - Who will have access to the data?
Local teams will be able to access their own data, as entered into the web-tool, with Excel spreadsheets. Automated run-charts will also be produced by the web-tool in real time, for selected key metrics, and compared against national data. Only the central PQIP research team will have access to the full dataset (anonymised).
Q. Data entry/follow-up - Will the webtool will be mobile friendly?
The webtool will be accessible with any internet browser.
Q. Data entry/follow-up - Will you provide an app for data entry?
An App will not be possible as we cannot risk confidential patient data being stored on an app on a mobile device which can then be lost. However, the website is mobile enabled, so as long as you have a wifi connection, you can enter data on your tablet (really easy) or a smartphone (the latter slightly more challenging because of the size of the pages).
Q. How long is the lifespan of the study?
The PQIP patient study will last for 4 years or until 70,000 patients have been recruited, whichever is the later
However, we hope that PQIP data collection will continue beyond this, as we bring on board other studies using our methodology and dataset.
Q. Is there funding available to support local data collections
There is no funding available to support local data collection, in line with other national audits/QI projects such as ICNARC or NELA. However, portfolio adoption should ensure that you can apply to your local clinical research network to access support for recruiting patients and data management locally. Please contact your local Clinical Research Network office for details.
Q. Is this study adopted onto the NIHR portfolio?
Yes – the portfolio (CPMS) ID number is 32256 and the lead Clinical Research Network is North Thames
Q. Recruitment - For how long after discharge will patients be followed up and by whom?
6 and 12 month follow up questionnaire as above. In addition, we will track patient survival using Hospital Episode Statistics and linkage to the Office of National Statistics’ mortality tracking system.
Q. Recruitment - How many patients will we need to recruit per week?
There are two options for recruiting patients
1. The protocol states that ideally 5 patients per week should be recruited, using a random sampling strategy which is detailed in the protocol. When we do our site set-up phone call with the local team, we will talk this through with you.
2. We are currently awaiting the outcome of a substantial amendment to the protocol which would enables hospitals with sufficient local resources to approach every eligible patient for recruitment. When we have confirmation of this we will let you know and put the revised protocol on the website.
Q. Recruitment - How will patients be selected?
For hospitals using the random sampling strategy, we will guide you in the recruitment strategy for your hospital and develop a bespoke system with you based on the types of surgery that you undertake. The general principle for our sampling strategy is that in week 1, the first 5 patients undergoing included procedures from Monday morning in week one will be identified from theatre schedules and approached for consent. If any of these patients refuses consent, consecutive patients will be approached until 5 have been recruited. We will use an 8-day rolling sampling cycle, so that in week 2, patients will start to be recruited from the Tuesday morning, the Wednesday morning of week three etc etc.
Q. Recruitment - Must patients be across specialities or could they alter weekly?
We will work with you to understand your surgical caseload and develop a sampling strategy which is feasible locally.
Q. Recruitment - What if I recruit a patient for an ineligible procedure?
A. If you have mistakenly recruited a patient to the study for an ineligible procedure you will need to contact the PQIP Helpdesk to request that the record is removed from the web tool.
Q. Recruitment - What types of surgery are included?
A full list of surgical procedures is included here (LINK)
Q. Recruitment - Where do you see patients being recruited?
We would encourage you to consider your local circumstances.
We envisage that patients would be informed of the study when they visit surgical or pre-operative assessment clinic, and then recruited to the study when they are admitted to the hospital for surgery.
Q. Recruitment - Will follow up be done from a central point or will sites be responsible for this?
Patients may elect to receive follow-up questionnaires (at 6 and 12 months after the date of surgery) by email or telephone calls. Emails will be sent by the central research team; telephone calls will be made by local teams using an agreed script.
Q. Recruitment - Will patient consent be required?
Yes, informed consent will be required and refusal or lack of capacity to consent is an exclusion criteria
Q. Recruitment - Would emergency patients or unscheduled patients be recruited?
Only patients for elective surgery should be approached.
Q. Where can I find the dataset and how will we enter PQIP data?
The CRF can be found in the "Study Documents" section of the website.
Once your hospital has agreed participation (including Caldicott guardian and R&D dept sign-off) we will provide you with logins to access the webtool.
The Standard Operating Procedures for the research team / clinician entered data is in the “Study Documents” section on the website
The patient questionnaires are also in this section of the website.
Q. Where can I find the protocol and other study documents for PQIP?
In the “Study Documents” section of the “Resources” Tab on the website.
Q. Who is able to take on the role of Management Lead? Can a nurse?
Yes, a nurse can be the management lead. The job descriptions for all local leads can be found here