Conclusions and recommendations

The work of WP4 was initiated to recommend an internal indicator set to be used in efforts to improve patient safety both at the system and organisation level and a brief rating assessment instrument for external application to provisional output.

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 European expert panel worked in a structured consensus process to fulfil the purposes of the work package.

Patient safety is a complex, important and a high priority area across health care systems in Europe. Patient safety improvement requires cooperation and mutual organisational learning at the system level, which entails changes that cut across units, professions, levels of hierarchy, and nations.

PSIs measure the extent to which set targets are achieved. They are expressed as numbers, rates or averages that can provide a basis for clinicians, risk managers, organisations and planners aiming at achieving improvement in all-round patient safety. Provided PSIs' data sources are accessible in a feasible, reliable, and valid way, PSIs are inexpensive and easy to use and provide reliable estimates of rates of preventable adverse events. Thus, PSIs are valuable as a higher-level safety performance measure.

The Stepwise Assessment Indicator Framework Approach (SAIFA) to select, characterise, and evaluate indicators and a set of 42 clinically multi-facetted PSIs were established covering aspect of the system and the organisational level. A Brief Assessment Instrument was developed and presented as part of the SAIFA. “The Brief Assessment Instrument” is suitable for use with other measures than PSIs.

A number of 28 existing known indicators, which have been clinically applied was described and evaluated. Also 14 new PSIs were characterised and evaluated by the expert group. Description of the PSIs can be found on www.simpatie.org. The 28 existing known indicators mainly originate from AHRQ and OECD. For the indicators of AHRQ, OECD and others we refer to the original extensive literature. The SImPatIE PSIs are meant for clinical use by single providers, whereas the OECD indicators are aimed at use by the health care system, in this way the PSIs of SImPatIE and OECD supplement another.
The SImPatIE PSIs are specifically selected to capture instances representing preventable adverse events in the inpatient setting. The PSIs cover patient risk and harm related to aspects of structure, process and outcome in the categories: Institution-wide Measures, Theme Related Measures (“Infections Control”, “Surgical Complication”, “Medication Errors”, “In- Hospital Fall”, “Obstetrics”) and Diagnose Specific as well as other Measures. The PSIs cover a wide spectrum ranging from surveillance of cultural assessment to measurement of standardised mortality rates.

The consensus process of the WP4 expert group was successfully completed leading to a recommendation of nine out of 12 new SimPatIE PSIs whereas 16 of 30 PSIs from existing programmes were recommended for implementation in parts or throughout EU. The PSIs from existing programmes have all been clinically applied.

As the same principles of patient safety apply equally to both primary care and hospitals and to all health professions as well as to health promotion, prevention, diagnosis, treatment, rehabilitation, and other aspects of health care, some of the PSIs might be highly relevant and usable in other settings than aimed at in the present context. However this must be investigated in detail.

The 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 subcultures 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 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 on wants to consider benchmarking. The questions uncovered in need of further investigation are:

• How is the quality of administrative data – does it match the definitions of the PSIs? Are further definitions needed to make the PSIs suitable for use?



• How do cultural differences (e.g. opinions, perceptions, attitudes, beliefs, values, norms, assumptions and expectations) concerning adverse events and errors among clinicians, hospital management, policy makers and planners etc. influence the decision of embarking on systematic collection of personal data for the sake of using PSIs to develop patient safety?



• What resources are needed in individual hospitals/nations of Europe to embark on using the PSIs for comparison or even for benchmarking?



• How is the data collection organised (centralised/decentralised)?



• Do individual hospitals/nations have informatics and reliable systems?



• How the availability of administrative data is – is it sufficient in its currents form?



• How do individual national legal systems allow data collection – especially with regard to data related to individuals?



• Not all European countries work with ICD-10 or DRG coding, how can this be handle for the PSIs where this coding applies in case of benchmarking?

In the workprocess 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:

• well organised and coordinated across member states
,

• elaborated
, and

• - continuously updated

,
to be useful and fulfill its purpose of cross-nation knowledge sharing and cooperation.

A literature review shows that monitoring and developing patient safety is impossible without the use of patient safety indicators to assess effectiveness, efficacy and effect of interventions. Thus compa-rison using PSIs is highly recommendable and necessary, although use of the recommended 28 PSIs implies methodological problems as the feasibility and quality of indicator data are varied along a number of dimensions across institutions and nations in Europe, we estimate that a subset of the indicators are usable in each EU country. Developing PSIs is an ongoing process in it self.

Additional work concerning homogeneous and comparable data and investigation of indicator sensitivity and specificity remains necessary prior to embarking on actual patient safety assessment activities using most of the PSIs for Europe wide common development here by supplying clinicians, risk managers, policymakers, and researchers with ongoing, comprehensive, and reliable data on patient safety. The methodology requires sophisticated resources in terms of informatics and reliable system wide patient identification and data processing. We strongly recommend that future projects on patient safety monitor follow up and investigate these aspects to develop assessment of effectiveness, efficacy and effect of interventions.