Summary

Summary

The objective of this work package of the SImPatIE-project was the development of a vocabulary and an internal indicator set for patient safety. This report describes the work done to establish the patient safety indicators (PSIs).

The ESQH-office for Quality Indicators in Aarhus, Denmark, was the lead partner of WP4. An expert group consisting of European representatives of project partners, stakeholders and external experts was established for achieving the aims of WP4.

The PSIs were derived through a formalised consensus process based on literature review, targeted information gathering, and expert consultation taking into account previous work done by the project partners and international quality and patient safety organisations. A literature search was performed. We searched for nationwide and international indicators programs known in a cross-European context. Literature for developing new indicators was also identified.

We developed a Stepwise Assessment Framework Approach (SAIFA) to select, characterise and evaluate the new PSIs and the existing indicators we wanted to review. The framework was based on the definition of the term "patient safety indicator" and the vocabulary framework developed by SImPatIE, WP4 and was followed by a charaterisation and an evaluation of the PSI. Indicators were characterised using the developed "Schemes for Characterisation of Indicators". Eight experts from six nations evaluated the PSIs on a scale ranging from 1 to 9 for "Relevance", "Validity and Reliability", and "Feasibility". Statistics for each dimension of the indicator formed the basis of recommendations in four categories from "recommended to be used throughout EU" to "not recommendable for implementation in EU".

A number of 28 known indicators, which have been clinically applied are described and evaluated. Also 14 new PSIs are characterised and evaluated by the expert group. Description of the PSIs can be found on www.simpatie.org. The PSIs are related to risk reduction and harm reduction and cover the dimensions; process and outcome. The PSIs are devided into subsets: "Institution Wide Measures", "Specific Measures" and "Theme Related Measures" covering the themes: "infection control", "surgical complications", "medication errors", "Obstetrics", and "Fall".

The existence of differences including aspects of organisational and clinical culture and sub cultures related to e.g. specialities and professions and also differences related to national, regional and local aspects led us to discommend a common "package" of PSIs for implementation in the EU at present. The consensus process was successfully completed leading to a recommendation of nine of 12 new SImPatIE PSIs whereas 16 of 30 PSIs from existing programmes were recommended for implementation in parts or throughout EU. Implementing the PSIs must be based upon thorough assessment of suitable data, considerations of interpretation, and publication of results.

Monitoring and surveillance of patient safety using PSIs depend on data that are varied along a number of dimensions. However, as the quality of administrative data vary across Europe embarking on the actual patient safety assessment activities using the PSIs across Europe entails additional work.

Introduction to WP4

Measures of aspects of quality of care have been developed and they are increasingly used in Europe being the promising answer to the demands for increased transparency and accountability while creating the basis for improvement and prioritisation in health care systems.

Patient safety has long been recognised as a dimension of quality of care and organisational performance. Care has become more and more complex over time, as the uses of technology as well as the number of effective treatments available have increased. Healthcare professionals are thus involved in increasingly complex care and the possibilities for adverse events have increased.

Patient safety is an outcome of many factors. While patient safety is the ultimate goal, belonging to “good outcomes” what ultimately determines safety is a safer care environment during the patients’ process of care.

Adverse events are systematically and frequently reported in European countries and analyses are made in order to learn from incidents and improve safety. This is resource consuming work, which creates a major need to measure dimensions of safety on an ongoing systematic basis, implement learning organisations, demonstrate ongoing safety improvement, determine when lapses in patient safety occur, and document positive effect of the efforts made. The quality improvement work is the role model of such an ongoing systematic monitoring, as it has proven to make the quality of process, structure and outcome visible.

Quality and patient safety studies providing evidence of the frequency of use of different tools are very few. In Western health care the most commonly used continuous quality improvement tools reported across a range of studies are: brainstorming, cause-effect diagrams, flow diagrams, and data collection tools such as forms for recording observations, and data display or analysis tools. Guidelines, protocols, and organisational procedures has been found to be the most commonly reported generic tools either for implementing the latest research or as part of continuous quality improvement projects to institutionalise changes tested by project teams (1) . The World Health Organization (WHO) synthesis found incident report data collection and analysis, root cause analysis, and crew resource management to be the most often reported in health care (1) .

Thus there is a major need to assess patient safety on an ongoing basis, systematic collection and analyses of PSIs can help prevent future “unsafe” actions of care and, in the long term, their adverse effect.

The SImPatIE project was made possible by a grant from the European Commission on ‘Public Health/Directorate General for Health and Consumer Affairs in 2004’ (OJ 2004/C52, 27 February 2004). This report represents the views of its authors and the expert group of WP4. These views have not been approved by the European Commission and should not be relied upon as a statement of the European Commission.

Objectives

The objective of the SimPatIE project is to use Europe-wide networks of organizations, experts, professionals and other stakeholders to establish, within two years, a common European set of vocabulary, indicators, internal and external instruments for improvement of safety in health care. The project is divided into eight so-called work packages that all aim for more specific objectives that together contribute to the overall project objective.

The objective of this work package was the development of a vocabulary and an internal indicator set for patient safety that is to be a part of a final project toolbox for improving patient safety. This report describes the work done to establish a set of recommendable PSIs.

Organisation

The ESQH-office for Quality Indicators in Aarhus, Denmark was the led partner of this work package (WP4). It was led by Prof. Jan Mainz, medical director of the Danish Institute for Quality and Accreditation in Healthcare, supported by Dr. Paul Bartels, medical director of the Danish Indicator Project. Overall project management and scientific work was executed by Master of Health Science Solvejg Kristensen.

The expert group consisted of representatives of project partners and external experts, with as members:

- MD, PhD. A. Bourek, University Center for Healthcare Quality, Masaryk University, Czech Republic
- Dr. I. Callanan, Vice President of the Irish Society for Quality and Safety in Healthcare
- Dr. K. Essinger, President, HOPE Subcommittee on Co-ordination (Appointed by HOPE)
- Dr. J. van Everdingen, chief medical officer of CBO (Appointed by CBO)
- Dr. J. Hansen, The Danish National Board of Health
- Dr. M. Kallewaard of the Association of Medical Specialists (Appointed by CBO)
- Dr. B. Lilja, Director of the Danish Society for Patient Safety, Denmark
- Dr. G. Maguerez (Appointed by HAS)
- Prof. Dr. med. G. Ollenschläger, Guidelines International Network (G-I-N)
- MD, PhD R. Suñol, Director of Avedis Donabedian Foundation (FAD).

Results to be achieved

The results to be achieved by the work package were:

• Defining a vocabulary related to patient safety, considering language, health care system organisation and economy and cultural issues across Europe


• Establishing a set of indicators / outcome measures that can be used in efforts to improve patient safety both at the system and organisation level (described in another report)


• Developing a brief rating assessment instrument for external application to provisional outputs (described in another report)

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Deliverables fulfilled

The work package delivers:

• A set of definitions of terms related to patient safety and a framework to illustrate the core terms of the vocabulary


• A set of indicators for use in efforts to improve patient safety (described in another report)


• A brief rating assessment instrument for external application to provisional outputs (see here)

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Overall approach taken

The work of WP4 was initiated and coordinated by the ESQH-office for Quality Indicators in Aarhus.

The expert group came together February 2006 with the purpose of introducing SImPatIE and WP4. SimPatIE project manager Benno van Beek, CBO took part in the meeting. The following presentations were given:

• Overall SImPatIE Project Plan and Organisation, by project manager Benno van Beek, CBO


• Related Work of Work Package 5, by Dr. Georges Marguerez


• Introduction to Indicators Including Qualifications and Characterisation by Prof. Jan Mainz


• Proposed Schemes for Classification and Evaluation of Indicators by Prof. Jan Mainz


• Patient Safety Indicators, by Dr. Paul Bartels


• Specific Issues of Definition and Methodology and an Overview of Available Materials and Ongoing Work on Taxonomy/Vocabulary, by Dr. Paul Bartels

A detailed work plan for WP4 was established and tasks were assigned.

The overall working method in the expert group has been telephone conferences. Development has been initiated and decisions made in a formalised consensus process. The method of developing the indicators is described in details later.

Prior to the meeting of the expert group an extensive literature search was initiated using the search terms: “Patient safety”, “Vocabulary”, “Glossary”, “Taxonomy” and “Indicator”. PubMed http://scholar.google.dk/ were searched. The literature search was repeated and extended in the process of the work and finalised towards the end of 2006. It was based on a review of similar studies and carried out by the Danish ESQH-office.

A literature review was carried out by the by the Danish ESQH-office in order to identify all relevant sources for the description of concepts and terminology related to patient safety and indicators. The review included work by the Council of Europe (CoE), European Comminities (EC), Organisation for Economic Co-operation and Development (OECD), Agency for Healthcare Research and Quality (AHRQ), European Community Health Indicator Monitoring (ECHIM), The Nordic Indicator Group etc. It was decided to take all identified available material – European and international - into account in the development of the indicators. Details of the literature/background sources related to the development of the PSIs are given later. A full reference list can be found at the end of the report (see here).