Applied concept of clinical audits

The concept of clinical audits has been developed based on experience gained from different types of control and checks carried out by authorised organisations and official agencies.

Clinical audit was designed in a way that auditing team consists of peers that are currently and directly involved in clinical practise. Thus, they are practitioners and can judge whether the audited activity is done properly from all points of view: adequately, accurately, diligently or scientifically justified. All of these activities can be adequately documented it the end. It then differs from other forms of control, which are often carried out by professionals, who have not practiced it for long time and who have been concentrating mostly on documentation and formal correctness.

How clinical audits are applied to our project?

In any study a reasonable simplification can be applied if:

  • it is appropriate with the assumed aim,
  • does not compromise the methodology, and,
  • does not lower the strength of obtained evidence below accepted level,

Therefore, our Team decided that the process of data collection will be done in the following way:

  • tutoring on how to collect the data and fill in the questionnaire with the first portion of data, which will be conducted by the external specialists (from ICO and GPCC),
  • data collection and completion of the questionnaire with remaining portions of data, which will be done by the internal team.

Our Team accepted the following methodology:

Step 1. Choice of pathologies and indicators – a whole group of experts from Partner Institutions

Step 2. Preparation of Questionnaire with detailed questions and set of answers where the answers are not left open (descriptive using open text) –  ICO team and then presented, discussed and accepted during Partner Meeting.

Step 3. Decision on statistics – number of cases to be included – proposal by ICO (Jose Borras) discussed and accepted during Partner Meeting.

Step 4. Audit at an Institution # 1.

A three-day visit. The visiting team will always consist of a project leader from ICO (Gloria Torres) and supporting specialist (WCO Specialist – to be decide who).

1st day – Visiting team (Gloria Torres and GPCC Specialist) meets with an internal group responsible (in the audited institution) for a discussion of rationale, objectives and details – 1 working day.

2nd day – Assisting local group, by one member of visiting team, in filling the questionnaire till late afternoon (3/4 of working day).

Expenditures for a meeting: team of 2 people:  1 – night (130 Euro); 1 – 2 nights (260 Euro); 2 air travels (2 x500 Euro = 1000 Euro) = 1390 Euro per visit.

Step 5. Completion of data by internal group at participating institution. In fact such an approach might put questions on objectivity, but it is justified by the overall concept of the study. In the first circle of the study, our team plans to see the significant discrepancies only and then get general knowledge of the practice at a participating institution – two weeks of 1/3 working days needed at each institution (10 days x ¾ day = 7,5 working days to be counted according to EU data)

Step 6. Interim meeting after first audit (at 1st institution) – whole group

The aim of the meeting is to account the encountered problems and incorporate necessary improvements.

If we want to do step 6a we need to prepare interim data for showing it to the public.

Step 6a. Promotion and fund seeking (GPCC team):

  • action using website,
  • approach to ESTRO,
  • looking for EU funds,
  • recruiting new Partners.

Step 7 to 8. Audit in the remaining institutions using methodology described in steps 4 to 6

Step 9. Meeting. Evaluation of the results (whole group):

  • statistical analysis,
  • discussion on the data,
  • preparation of data for publication,
  • decision on further steps  – new circle or other pathologies.

Step 10. Preparation of manuscript for publication – 3 months.