Appendix I. Research agenda
The Committee of Ministers, under the terms of Article 15.b of the Statute of the Council of Europe,
Considering that the aim of the Council of Europe is to achieve a greater unity between its members and that this aim may be pursued in particular by the adoption of common rules in the health field;
Considering that access to safe health care is the basic right of every citizen in all member states;
Recognising that although error is inherent in all fields of human activity, it is however possible to learn from mistakes and to prevent their reoccurrence and that health-care providers and organisations that have achieved a high level of safety have the capacity to acknowledge errors and learn from them;
Considering that patients should participate in decisions about their health care, and recognising that those working in health-care systems should provide them with adequate and clear information about potential risks and their consequences, in order to obtain their informed consent to treatment;
Recalling that Article 2 of the Council of Europe’s Convention on Human Rights and Biomedicine (ETS No. 164) establishes the primacy of the human being over the sole interest of society or science, and recalling its Article 3 on the equitable access to health care of appropriate quality;
Considering that the methodology for the development and implementation of patient-safety policies crosses national boundaries and that their evaluation requires substantial resources and expertise and should be shared;
Recalling its Recommendations Nos. R (97) 5 on the protection of medical data, R (97) 17 on the development and implementation of quality improvement systems (QIS) in health care, and R (2000) 5 on the development of structures for citizen and patient participation in the decision-making process affecting health care, and its Resolution ResAP(2001)2 concerning the pharmacist’s role in the framework of health security, which explicitly suggests working in partnership with other health professionals;
Noting the relevance of the World Health Organisation (WHO) “Health for All” targets for the European Region (target 2) and of its policy documents on improving health and quality of life and having regard to its Health Assembly Resolution 55.18 (2002) on “Quality of care: patient safety”, which recognises the need to promote patient safety as a fundamental principle of all health systems;
Considering that patient safety is the underpinning philosophy of quality improvement and that all possible measures should therefore be taken to organise and promote patient-safety education and quality of health-care education;
Considering that the same principles of patient safety apply equally to primary, secondary and tertiary care and to all health professions as well as to health promotion, prevention, diagnosis, treatment, rehabilitation, and other aspects of health care;
Recognising the need to promote open co-ordination of national and international regulations concerning research on patient safety,
Research agenda
See Appendix I (pdf-file) of Recommendation Rec(2006)7 of the Council of Europe
NOTE: text markers added to increase readability (not applied in the original).
The development and implementation of an effective patient-safety policy requires sound evidence (as opposed to mere opinion). Therefore, applied research on patient safety is a vital component of a comprehensive strategy to address this problem. Areas that should be considered for inclusion in research programmes include:
a. descriptive, qualitative studies of patient-safety incidents in all health-care settings, including out-patient care, home care, acute hospital care and rehabilitation;
b. analytical, quantitative epidemiological, preferably prospective, studies to identify risk factors for patient-safety incidents and iatrogenic complications;
c. experimental research on human factors and human error, and on modifiable factors that decrease the likelihood of error. The studies on human-technology interaction should be included;
d evaluation of the most effective ways of involving patients in the prevention and management of incidents;
e. development and validation of patient-safety indicators;
f. simulation studies and small-scale pre-tests to identify potentially effective interventions to improve patient safety;
g. evaluations of the real-life effectiveness of interventions to improve patient safety, and of unintended side-effects of such interventions;
h. studying the processes of care and safer practices;
i development and introduction of instruments promoting the prevention of adverse events. The Failure Mode and Effects Analysis (FMEA) is one example of tools to prevent a failure before any harm is done. Less known in health-care organisations, they should be adapted, tested and, where appropriate, implemented;
j. appropriate procedures to ensure safety of experimental diagnostic and therapeutic procedures;
k. methods (including e-learning and other innovative approaches) to educate health professionals in a safety culture and in safe practice.
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