Methodology

Methodology

The methodology described in the contract document was modified to a small degree in practice in that literature review played little role in the construction of the survey instrument which was designed via the use of an expert panel and on the basis of expert consensus, with feedback from participants as to clarity, usability, completeness and fitness for purpose. In other respects, the role of partners, the value of incorporation of the work from the Council of Europe exercise etc. were as envisaged.

Remarks

It is a given that this exercise represents a ‘first cut’. That is, the best approximation of the data available working within the resource constraints of the present project. As a result there will inevitably be some inconsistencies, resulting particularly from: lack of adequate validation; disagreements between respondents; difficulties with voca-
bulary; and the fact that this is a ‘snapshot’ of what is a continuously evolving picture. Where possible, in the text that follows, inconsistencies and possible explanations for them will be identified. Inevitably not every inconsistency will be dealt with. Nevertheless, we are satisfied that the main objective, to obtain a crude but useable overview of patient safety activity in Europe as of December 31st. 2006, has been achieved.

To acknowledge the above factors, the text will normally present results in the form “the country reports that…” as a short hand for “the available data from one or more respondents (including data from Best Practice Compendium) allows us to summarise the position in this country as…”. In other words, some assumptions are being made, for the sake of practicality, although those interested in exploring responses in more depth can pull out the individual items from the database and draw their own conclusions.

Work package develpment

The Simpatie European mapping exercise was initiated in February 2005 as the first phase of the set of work packages that comprise the programme. The main phases of activity have been:

February – April 2005
Background research and developing an understanding of allied programmes, recruiting the experts’ and reference groups and running an initial reference group workshop to develop the first draft of the research framework.

April – September 2005
Collaboration with WHO Europe leading to a joint symposium in Copenhagen in September 2005, input into development of the Simpatie website and pilot testing the instrument (the questionnaire).

September – November 2005
Refinement of the survey instrument and collection of data against the first five areas of enquiry.

November 2005 – July 2006
Collection of data for the remaining sixteen areas of enquiry.

July 2006 – November 2006
Further collection of data in the interests of ensuring a comprehensive coverage together with verification/validation of the data and start of data analysis. Preliminary consideration of mapping data alongside results of work packages
3, 4, 5 & 6 (Council of Europe recommendations and toolbox results i.e. vocabulary, indicators and tools).

November 2006- December 2006
Collection of good practice examples and entry of data from mapping & good practice exercise onto Simpatie database.

Data to be collected

The data to be collected was summarised in question form into a survey instrument with twenty-one different questions, and within these in excess of one hundred different data items to be collected. Most were questions of fact, but some were of opinion. Some sought further information on resources, or to steer towards the direction of further work covering a particular issue. In all, the survey instrument aimed to establish a comprehensive and wide-ranging insight into progress with patient safety initiatives in the respondent countries.

The survey instrument divides into various parts, and the twenty-one questions have the following
themes and rationale for being worthy of investigation:






A (blank) copy of the full questionnaire is attached as Appendix G (pdf-file).

Q Theme Reason for interest 1. Standard use of an in country definition for patient safety As a first step it was felt important that countries had addressed the issue of what was meant by patient safety, and whether they were using a definition that was drawn from existing international work (in particular, the Council of Europe work) 2. National bodies or insti-tutions active in patient safety work The existence of national bodies specialising in patient safety, or programmes of work in national bodies (i.e. regulators) that had been specifically designed to promote patient safety initiatives. This would provide a guide to coordinated investment of effort in patient safety nationally 3. Taxonomy to classify patient safety reports Whether there was an agreed national taxonomy for patient safety and incident reporting. Agreement of a national taxonomy would make initiatives such as benchmarking feasible 4. The use of standards/ guidelines to control and minimise harm to patients This would help identify whether commonly used methods for quality assurance and improvement (standards and guidelines) were specifically being used as a tool for contributing to patient safety efforts 5. In country experts in the field of patient safety This would establish both that there were local patient safety experts, and also provide the Simpatie programme with contacts for further enquiry. 6. Any national incident reporting system Developing a national reporting system has been seen as a useful first step in raising patient safety as an issue within countries. 7. Requirements for or exis-tence of local incident reporting systems As an alternative or supplementary stage to the existence of a national reporting system, the requirement for or existence of systems to collect local patient safety data has been a useful step to engineering improvement efforts 8. No fault/ no blame compensation schemes (definition & comments, see below, p.20) No fault compensation schemes have helped to reduce professional and organisational concern around collecting patient safety data. They can be seen as a way of helping to manage public interest concerns in relation to patient safety 9. Requirements to legally disclose information prin-cipally collected to support patient safety activities (adverse incident data) The protection of patient safety information from potential use in compensation cases is seen as a constructive step in creating an appropriate blame free culture, and in having access to information about incidents and near misses in a manner that protects institutions and clinicians from litigation 10. The public availability of information relating to patient safety incidents The broad availability of data relating to patient safety incidents is seen as a way of helping to build a local and in country awareness of patient safety problems. It provides benchmarks to establish progress in reducing errors and near misses over time. It helps build compare-sons, and provides information about the likely effectiveness of reporting systems in terms of the completeness of reported incidents 11. Professional liability arrangements This helps build an understanding of the way in which different countries have sought to ensure that professionals have access to professional liability cover, and that patients can be compensated when clinical errors which cause harm occur 12. Whistle-blowing policies (definition, p.25, below) A blame free culture depends on professionals being able to openly discuss service problems and report incidents and near misses. A whistle blowing policy and methods of protecting members of the team when discussing the performance issues of others is seen as a constructive step in bringing this about. 13. Professional patient safety membership organisations The organisation of a working group of colleagues from healthcare interested in patient safety is seen as a useful tool in developing patient safety skills, and developing a national movement to tackle the issue over time. 14. Healthcare risk management qualifications Training specifically relating to risk management in healthcare is seen as an essential step to building national capacity to address patient safety problems. 15. Professional support for patient safety or healthcare risk managers The development of a patient safety discipline and networking opportunities for those with this task as their principal work is seen as a useful building block for local resolution of patient safety issues. 16. Patient safety training opportunities and require-ments for healthcare staff Specifically training clinicians and healthcare managers in patient safety awareness and techniques is seen as an essential step to tackling the problem and reducing the likelihood and consequences of patient safety incidents.
17. Specialist patient safety patient organisations Specialist patient organisations with an interest in patient safety provide a means whereby patients can understand their rights, gain support, be provided with information and participate in becoming guardians of their own safety within a healthcare system. 18. National patient safety campaigns and public relations exercises The existence of national campaigns and public relations interventions to address patient safety matters is an important step in helping to build a culture where patient safety is understood, taken seriously and makes progress in implementing improvements more possible. E.g these would include issues such as hand washing, communication with patients or the importance of completing antibiotic regimes. 19. Professional peer review schemes with patient safety content This question looks at whether routine professional quality improvement activities are inclusive of patient safety issues and patient interests. 20. The role of European bodies in patient safety This question aimed to gain an insight from participants into ways in which pan-European bodies could be useful to promoting patient safety campaigns or initiatives. 21. The usefulness of patient safety resources Patient safety initiatives seem to spread much more rapidly through Anglophone countries than other countries. Also it was noted that some of the principal drivers were the early studies which helped provide evidence of the extent and nature of the patient safety problem. This question asks whether the availability of these resources, translated into other languages, would be seen as a useful and helpful step to supporting patient safety developments.