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Vocabulary & IndicatorsWorking package 4: Safety Improvements for Patients in EuropeFinal Report, March 2007, The ESQH-office for Quality Indicators, Denmark
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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; and - A brief rating assessment instrument for external application to provisional outputs. The ESQH-office for Quality Indicators in Aarhus, Denmark was the lead partner of this work package (WP4) in terms of organisation. An expert group consisting of European representatives of project partners, stakeholders and external experts was established for the achievement of the aims of WP4. Regarding methodology: the expert group came together February 2006 in order to introduce SImPatIE and WP4. The SImPatIE project manager Benno van Beek, CBO, took part in the meeting. A detailed work plan for WP4 was established and tasks were assigned. 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 to descriptions of indicators. The review included work by the Council of Europe, European Comminities, Organisation for Economic Co-operation and Development (OECD), Agency for Healthcare Research and Quality (AHRQ), European Community Health Indicator Monitoring, The Nordic Indicator Group, etc. It was decided to take all identified available material – European and international - into account in the indicator-development. 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(s). Selecting and defining terms, and clarifying the concepts were done in a formalised consensus process in a sub-group to the expert group, interacting with the expert group. The work was executed using telephone conferences and mail correspondence, the sub-group meat once in the developmental process to deepen the work. The final draft of the vocabulary was sent to the expert group and two patients’ representative for comments. Comments were discussed in a telephone conference of the subgroup, alterations were made accordingly and the vocabulary finalised. The patient safety indicators 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. We developed the Stepwise Assessment Framework Approach to select, characterise and evaluate both new PSIs and indicators from existing programmes. The framework was based on the definition of the term “patient safety indicator” and the vocabulary framework 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 used throughout EU” to “not recommendable for implementation in EU”. Five Institution-Wide PSIs were commented by a patient representative taking into account for experiences gathered by the organisation “Action against Medical Accidents”. In terms of work-description: a set of 24 definitions of patient safety terms and a framework illustrating the connection of the five core terms of the vocabulary are available for use in a cross European context. The vocabulary is aimed at professionals, e.g. risk managers, administrators, project managers and others working with patient safety. The vocabulary covers the domains: “Detection of Risks”, “Analysis of Risks”, “Resulting Actions” and “Failure Mode”. The vocabulary is available in English language via simpatie.org. The vocabulary is aimed at professionals e.g. risk managers, administrators and others working with patient safety. A “Brief Assessment Instrument” was developed and presented as part of the Stepwise Assessment Indicator Framework Approach. The instrument is suitable for use with other measures than PSIs. All together 42 PSI were described and evaluated: 28 existing known indicators, mainly originating from AHRQ and OECD and 14 new SimPatIE PSIs. Description of the PSIs can be found on www.simpatie.org. The PSIs are relating to risk reduction and harm reduction and covering the dimentions; 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 PSIs cover a wide spectrum ranging from surveillance of cultural assessment to measurement of standardised mortality rates. 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. To coordinate between the work of WP4 and the other work packages at least one representative of the ESQH-office in Aarhus continuously took part in telephone conferences, overall project meetings, steering group meetings, and congresses. Patients were represented in various ways; the organisation “Action against Medical Accidents” (AvMA), an independent English charity promoting better patient safety and justice for people who have been adversely affected by a medical accident were represented in the over all project meetings. A range of international and national patient interest groups and organisation representatives participated the SImPatIE Consensus Conference in Luxembourg. Two patients’ representatives reviewed and commented the vocabulary, and one patient representative reviewed and commented on five PSIs. The organisation HOPE and a patient representative commented on a draft of the two reports on the vocabulary and the PSIs and the characterisation of the PSIs. Conclusions and recommendations of WP4. The vocabulary provides a basis of achieving greater unity of patient safety work in Europe - especially it serves as a basis for applying patient safety evaluation tools of the toolbox of SimPatIE WP4 and WP5. The vocabulary is explicitly neither a taxonomy nor a classification of adverse events. For such works we refer to the International Patient Safety Event Classification by the World Health Organisation.
The 42 established PSIs present a set of possible measures of patient safety. The themes and areas covered by this set are not intended to be exhaustive in the development of patient safety. E.g. within the area of measures of medication errors no indicators for “sound-alike” and “look-alike” medications are established. Though we find it highly relevant to work with these themes to improve safety, more suitable methods than PSIs can be found, and we support work in progress by project partners. The PSI concerning patients understanding of their medication at discharge from hospital can be seen as a supplement to medication reconciliation, which is part of the High 5s Initiative. In this context we recommend the continuous use of PSIs supplemented by other measures and initiatives to improve safety. Each institution must carefully plan, develop, and evaluate patient safety. Due to patient safety cultural differences, which includes aspects of organisational and clinical culture and sub cultures e.g. related to specialities and professions as well as cultural differences related to national, regional and local aspects we do not recommend a common “package” of PSIs for implementation in EU. Prior to embarking on actual patient-safety assessment activities using the PSIs, a systematic strategy should be established at an institutional or regional level to measure, report, and use information. Implementing the PSIs must be based upon thorough assessment of suitable data, considerations of interpretation and use, and publication of result, especially considering that patients should participate in decisions about their health care, while recognising that health-care workers should provide patients and potential patients with adequate and clear information about potential risks and consequences. In connection with the rating of the dimension “Feasibility” of each PSI, the expert group discussed aspects such as data availability, the quality and features of administrative data present available, resources available, organisation of data collection in individual EU countries, legal systems concerning data collection individual data etc., These aspects are not systematically deepened and uncovered by WP4 for EU, but we found common traits leading to questions, which need to be followed up upon, if one wants to use the PSIs for comparison over time or even benchmarking building up European Patient-Safety-Indicator-Database. Some of these questions need to be taken carefully into account when planning to use the PSIs for comparison over time – some are more relevant if one wants to consider benchmarking. The questions uncovered in need of further investigation are:
In the work process of WP4 we uncovered that several member states work with different PSIs. We discussed the use of the PSIs and we believe that several of the used PSIs are suitable for spreading and using in Europe to a larger extend than what we found is the case to day, thus we recommend a common European Patient-Safety-Indicator-Library containing information on indicators relevant for developing and monitoring patient safety. Such a European Patient-Safety-Indicator-Library must as a minimum be:
to be useful and fulfil its purpose of cross nation knowledge sharing and cooperation.
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