FAQs

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Yes – the portfolio (CPMS) ID number is 32256 and the lead Clinical Research Network is North Thames

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In the “Study Documents” section of the “Resources” Tab on the website.

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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.

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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.

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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.

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Yes, a nurse can be the management lead. The job descriptions for all local leads can be found here

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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.

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Yes, informed consent will be required and refusal or lack of capacity to consent is an exclusion criteria

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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.

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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.

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A full list of surgical procedures is included here (LINK)

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Only patients for elective surgery should be approached.

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We will work with you to understand your surgical caseload and develop a sampling strategy which is feasible locally.

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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.

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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.

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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.

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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).

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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.

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Any member of the local clinical or research team who has a personal login to the web-tool.

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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.

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The webtool will be accessible with any internet browser.

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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).