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Methodology

Initiating the work package


Two international groups were set up, the experts’ network and the reference group. The experts’ group consti-
tuted individuals who acted as contact points in each country and who agreed to help with collection of data via their in-country contacts. Through this arrangement, and taking into account the identification of country experts within Question 5 of the survey instrument, it has been possible to create a network of more than 100 experts (nominated by their peers) across 23 countries. This group provided the basis for rapid collection of good practice examples during November and December of 2006 and it is obvious that this network has the potential for further development if a second phase of the project were subsequently to be initiated (see Discussion and Conclusions, below). CPME and HOPE, two of the consortium partners, were particularly helpful in supplementing country data with information from colleagues within their own networks. Peter Walsh of AvMA, was delegated by LMCA and advised on all patient issues.

The experts’ group was therefore to an extent drawn together by serendipity, and because one agreed aim was to mobilise both networks and opinions outside those already involved and researched, a reference group was set up in parallel. This group consisted of colleagues from different countries, but more importantly who were representative of the different professional and special interest stakeholders that the data was to be of service to. Therefore this group was recruited from patient safety experts, academics, healthcare policy makers and managers, clinicians, those representing the interest of patients, professional organisations, specialist healthcare risk managers, commentators, lawyers, quality improvement specialists, regulators and educationalists. The group maintained contact and had occasional face-to-face meetings throughout the duration of the project.

The initial meeting of this group was hosted by one of the reference group members in Luxembourg. This meeting came up with an initial framework for the data collection (and see Appendix A). It catalogued the potential interest areas for the different parties who might utilise the end product of the Simpatie mapping exercise once the project was completed. As the survey instrument developed it was shared between the Simpatie partners and the reference group and pilot tested to check clarity, usability, completeness and fitness for purpose. This included the input of experienced social scientists practiced in the use of survey instruments, and healthcare experts from different countries to check on the use of terms and definitions. The instrument was in English and invited responses in English only, although attached documents in the language of the particular country were welcomed.

Although based on principles derived from previous quality mapping, e.g. CASPE/BIOMED2 survey of External peer review in Europe (ExPeRT project), it is evident that the questionnaire format stems primarily from consensus between selected experts, rather than from scientific research. Nevertheless feedback from respondents suggests no major omissions in the span of the questions (potential sources of variance are identified in preliminary 'health warning' above). Future mapping exercises might incorporate into survey design both lessons learnt from projects such as this one and those from review of research literature.

As for the Good Practice Compendium, a ‘health warning’ is posted on p.2 of its final report, which will be repeated here, namely that examples for inclusion in the Compendium were nomination by other experts. Therefore there is no formal evidence base for these examples being good practice, nor validation of content other than the expert opinion of the nominating person.

The data to be collected


The data to be collected was thus 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.