Record Review Studies in Switzerland Potential and Limitations

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1 Record Review Studies in Switzerland Potential and Limitations Charles Vincent Smith and Nephew Foundation Professor of Clinical Safety Research Clinical Safety Research Unit Drivers of patient safety Quality of care initiatives Litigation High profile cases & system breakdowns Bristol Royal Infirmary Winnipeg Cardiac Surgery Psychology & human factors Professional and government reports 1

2 Epidemiology of harm: record review Study Date of admission Number of hospital admissions Adverse event rate (% admissions) California Insurance Study * Harvard Medical Practice Study Utah-Colorado Australian United Kingdom Denmark New Zealand France ** Canada Why conduct record reviews in Switzerland? Getting attention Motivation ethical and financial Planning & Prioritisation Comparison of data sources Action! 2

3 Early pioneers `It may seem a strange principle to enunciate as the very first requirement in a Hospital that it should do the sick no harm. It is quite necessary, nevertheless, to lay down such a principle, because the actual mortality in hospitals is very much higher than any calculation founded on the mortality of the same class of diseases among patients treated out of hospital would lead us to expect 3

4 Extrapolation to Switzerland: Approximate figures for illustration (2000) 1 million admissions per year Possible ,000 adverse events- half preventable ,000 additional bed days at 1000 SF per day Cost in extra days in hospital million Swiss Francs per annum - half preventable These figures take no account of litigation, complaints, staff time, impact on patients and staff, disability benefits Methods of Studying Adverse Events Morbidity and mortality conferences and autopsy Case analysis/ Root cause analysis Claims analysis Error reporting systems Administrative data analysis Record review/chart review Review of electronic medical record Observation of patient care Active clinical surveillance 4

5 Methods of Studying Adverse Events Study Method Morbidity and mortality conferences and autopsy Case analysis/ Root cause analysis Claims analysis Error reporting systems Advantages Can suggest contributory factors Familiar to health care providers Can suggest contributory Structured systems approach Includes recent data from interviews Provides multiple perspectives (patients, providers, lawyers) Provide multiple perspectives over time Can be a part of routine operations Disadvantages Reporting bias Focused on diagnostic errors Infrequently used Tends to focus on severe events Insufficiently standardized in practice Reporting bias Nonstandardized source of data Reporting bias Administrative data analysis Uses readily available data Inexpensive May rely upon incomplete and inaccurate data The data are divorced from clinical context Record review/chart review Review of electronic medical record Observation of patient care Uses readily available data Commonly used Inexpensive after initial investment Monitors in real time Integrates multiple data sources Potentially accurate and precise Provides data otherwise unavailable Detects more active errors than other methods Judgements about adverse events not reliable Medical records are incomplete Susceptible to programming and/or data entry errors Expensive to implement Time consuming and expensive Difficult to train reliable observers Potential concerns about confidentiality Possible to be overwhelmed with information Active clinical surveillance Potentially accurate and precise for adverse Time consuming and expensive events (Adapted from Thomas and Petersen, 2003) Which method? Depends on: Purpose of study Resources available Need for systematic data Methodological issues 5

6 Claims Complaints Adverse Events = Harm to Patients Studies of Errors Informal communication Observation Reporting systems Can we rely on incident reporting? Contemporaneous case record review Incident reports Olsen & Neale, 2005; Sari et al

7 Record Review Strengths Established methodology Uses readily available data Now developed for routine use Relatively inexpensive Systematic assessment of adverse events Limitations Medical records may be incomplete Judgements not always reliable Some dispute about findings (mostly deaths) An agenda for Switzerland (2000) Building on existing initiatives Identify all existing research and implementation safety programmes Anaesthetic critical incident reporting Closed claims project Team training etc Build on what you already have Respect local initiatives 7

8 An agenda for Switzerland Nature and causes of adverse events Consider a record review study focused on costs, causes and prevention Review and co-ordinate existing sources of data Local and national reporting systems Guidelines for adverse event analysis An agenda for Switzerland Implementation Identify important targets for risk reduction Identify targets for immediate gains Identify measures where evidence is strong Electronic prescribing Guidelines and protocols etc Develop long term risk reduction strategy for major targets 8

9 An agenda for Switzerland Organisation and Infrastructure Establish a National Patient Safety Centre Invest in research, training and implementation of safety initiatives Remember that adverse events are very frequent and very costly - both in human suffering and financially Establish a European Centre for Patient Safety? 9

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