Qual Saf Health Care 2004;13: doi: /qshc

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1 226 WORLD VIEW How safe is the paradigm? O A Arah, N S Kazinga... This paper reviews initiatives in the heath systems of the UK, Canada, Austraia, and the US. Initiatives to tacke shortcomings invove pubic-private coaborations. Patient agencies (to institute earning, action and cuture), adverse event reporting and, to a esser extent, reated performance indicators are currenty used to design safer heath systems. Their benefits are mixed, but there is itte debate as to their possibe side effects. Foreseeabe adverse effects of mutipe organisations stem from them being too many, too vague, too narrowy focused, threatened by the medica practice environment, and too optimistic. Safety reated performance indicators are most deveoped in the US but suffer from inadequacies of administrative data, underreporting, variabe indicator definitions, extended use, and ow sensitivity of the diagnosis coding system, and arguabe preventabiity of the prescribed conditions. A critica appraisa of the impications of these deficiencies is important to assure the of current heath system initiatives and to estabish evidence based. It is necessary to embed heath system (as we as patient ) in the societa cuture, structures, and poicies which promote effective, user centred, high performance care whie aowing for heathy innovation.... See end of artice for authors affiiations... Correspondence to: Dr O A Arah, Department of Socia Medicine, Division of Cinica Methods and Pubic Heath, Academic Medica Center, University of Amsterdam, P O Box 22700, Amsterdam 1100 DE, The Netherands; o.a.arah@amc.uva.n Accepted for pubication 12 March H eath system matters because apses in harm patients, their famiies and, utimatey, society. Media coverage of many cases of serious injury or death as the resut of unsafe heath care has heightened pubic concern about heath care. In response, poicymakers have, in many countries, issued reports or set up agencies to try to tacke a probem that is ceary ongstanding and endemic. However, ike the wider agenda of heathcare quaity, 1 patient has ony recenty become a priority on the poicy agenda. This recent attention focuses on the risks of harm from heath care (for instance, dangerous drug overdose), the risks in the care environment (for a patients and providers), the fawed system designs which enabe injury occurrence, 2 6 and better patient invovement in harm management. 7 Foowing these considerabe pubic, professiona, and poitica interests in patient, severa industriaized countries for exampe, UK, 8 9 Canada, Austraia, Denmark, and USA 5 have now estabished initiatives. Notaby, these interests have resuted in Qua Saf Heath Care 2004;13: doi: /qshc arge pubic-private coaborations, organizations, adverse event reporting systems, 16 research into errors and adverse events, and cas for system redesign Aso, patient has become a core dimension of performance measurement and management frameworks. However, these initiatives raise severa questions. What are the key components of the efforts and what are they actuay aimed at? Can other countries reay adopt simiar initiatives? If so, are they sufficienty safe and sound for crossnationa earning? Wi such initiatives sove the probems of heath system? Athough is the topic of a growing number of scientific papers, few artices have tried to critique the actua reactions to in heath care. In this paper we briefy examine the nationa agenda on and measurement of patient in four advanced heath systems namey, the UK, Canada, Austraia, and the USA and refect on the potentia shortcomings of these efforts. Athough it is not our intention to give an exhaustive overview of nationa efforts in these four countries, we want to start a refective discussion on their nature, direction, and potentia shortcomings. Our approach consisted of (1) exporing the reevant iterature, documents, and websites on in the UK, Canada, Austraia, and the USA; (2) seeking information from the reveaed agencies to summarize their goas and current activities; (3) reviewing their nationa heath system performance frameworks and indicators; and (4) where possibe, searching the scientific iterature for supporting evidence for reated performance indicators seen in nationa indicator frameworks. We then refected on a findings (summarized in the accompanying tabes) from a systems perspective. This exporatory poicy anaysis entaied reviewing the key issues on the agenda and examining the whats and whys of these issues. The key findings are presented in two sections on (1) nationa patient agencies and reporting systems and (2) reated performance indicators. NATIONAL PATIENT SAFETY AGENCIES AND REPORTING SYSTEMS Tabe 1 gives an overview of the nationa patient agencies found in the four countries. UK The British take quaity and in the NHS quite seriousy The Bristo case and other high profie affairs probaby served to pace the debate in the pubic domain. Foowing these events and two major pubications, 8 9 the government set up the Qua Saf Heath Care: first pubished as /qshc on 2 June Downoaded from on 23 August 2018 by guest. Protected by copyright.

2 How safe is the paradigm? 227 Tabe 1 Leading patient organization(s) Nature Overview of nationa patient agencies UK* CanadaÀ Austraia USA` Nationa Patient Safety Agency* Specia heath authority set up by the UK government (Statutory Instrument 2001 No. 1743) Heath Canada (HC); Canadian Institute for Heath Information (CIHI) and the Canadian Institutes of Heath Research (CIHR); Nationa Steering Committee on Patient Safety (NSCPS) HC: Federa Ministry of Heath, Canada; CIHI: independent, not-for-profit body for quaity heath information; CIHR: premier federa agency for heath research; NSCPS: an organ of the Roya Coege of Physicians and Surgeons Nationa Patient Safety Agency (NPSA) The NPSA coates, anayzes, and feeds back information on apses in patient within the NHS, and works with NHS staff and organizations to promote a fair and open cuture (tabe 2). 25 It aso recenty introduced a nationa reporting and earning system across the NHS to compement oca eve vita reporting, earning and action. Some exampes of other stakehoders who are nationay or ocay invoved in patient across the UK are shown in the footnotes to tabe 1. Canada Heath Canada, the Canadian Institutes of Heath Research (CIHR), and the Canadian Institute for Heath Information Austraian Counci for Safety and Quaity in Heath Care (ACSQHC); Austraian Patient Safety Foundation (APSF) ACSQHC: nationa counci set up by the Austraian Federa Heath Ministers; APSF: non-profit independent organization dedicated to the advancement of patient Agency for Heathcare Research and Quaity (AHRQ); Nationa Patient Safety Foundation (NPSF); Joint Commission on Accreditation of Heathcare Organizations (JCAHO) AHRQ: nationay authorized agency for quaity and research; NPSF: not-for-profit, mutidiscipinary body; JCAHO: independent, not-forprofit, standards setting and accrediting body in heath care Web address medica.org Year nationa Juy 2001 May 2002 (CIHI/CIHR hospita 2000 (ACSQHC); 2000 (AHRQ); program started study funding) 1989 (APSF) 1998 (NPSF); 19961; 2002** (JCAHO) Mission Operationa mechanism Remarkabe pubic event(s) on patient To coordinate efforts to earn from adverse events and near misses in the NHS; to promote openness and fairness, ead reporting and feedback; to monitor progress; to promote an open and fair cuture in the NHS Estabishing and operating a new, mandatory nationa reporting system for adverse events and near misses ; provision of nationa eadership and guidance Shipman and Ledward affairs; high profie intratheca vincristine deaths, 31 etc; Bristo case 1996 (2001 inquiry report); An Organization with a Memory, Buiding a Safer NHS for Patients HC: To coordinate nationa agenda; CIHI/CIHR: To examine the extent of adverse events in Canadian acute care hospitas and avaiabiity of data for continuous monitoring and reduction of events; RCPS NSCPS: To deveop framework and pan for Canadian patient efforts CIHI/CIHR: Reviewing randomy seected patient hospita records by speciay-trained physicians and nurses who beong to the research team Lack of prior nationay coordinated initiative; error incidence unknown ACSQHC: To ead a nationa and coaborative approach to improve and quaity of patient care; to deveop a nationa framework, put the consumer first and promote research; APSF: To eiminate preventabe harm in heath care ACSQHC: Using annua action pans to achieve its priority areas; committing to a Nationa Patient Safety Research Centre, a Nationa Centre for Patient Safety Improvement, system capacity buiding, accreditation and standard setting mechanisms; APSF: Using its Austraian Incident Monitoring System Incident monitoring in anesthesia (1987/88); 43 the Quaity in Austraian Heath Care Study (1995) 38 AHRQ: To support research designed to improve the outcomes and quaity of heath care, reduce its costs, address patient and medica errors; NPSF: To improve patient knowedge and awareness JCAHO: To ensure a greater focus on priority safe practices AHRQ: Deveoping errorreduction technoogies; conducting demonstration projects and error reporting strategies; supporting research NPSF: Identifying and appying pathways; raising pubic awareness; JCAHO: Roing goas for accreditation; reporting and anaysis of sentine events Harvard Medica Practice studies (1991/1995); NPSF s Annenberg conferences (1996, 1998, 2001, 2002); 51 IOM s report: To Err is Human (1999/2000) 5 *Other UK stakehoders incude Nationa Cinica Assessment Authority, NHS Litigation Authority, Commission for Heath Improvement, Coroner, Heath Authority, Medica Devices Agency, Heath and Safety Agency, Medicines Contro Agency, and Serious Hazards of Transfusion (SHOT). ÀOther initiatives are from the Canadian Counci on Heath Services Accreditation (CCHSA), Canadian Society of Hospita Pharmacists (CSHP), the Institute for Safe Medication Practices (ISMP Canada), Canadian Coaition on Medica Incident Reporting and Prevention (CCMIRP), Canadian Heathcare Association (CHA), Canadian Nurses Association (CNA), and provincia/territoria patient initiatives. `Other nationa agencies in the US incude the US Pharmacopoeia (USP), Food and Drug Administration (FDA), the Institute for Safe Medication Practices (ISMP), Centers for Disease Contro and Prevention (CDC), Centers for Medicare and Medicaid Services (CMS), the Nationa Forum for Heath Care Quaity Measurement and Reporting (NQF), the Quaity Interagency Coordination Task Force (QuIC), the Leapfrog Group for Patient Safety. 1JCAHO s sentine event poicy. **For JCAHO s nationa patient goas. (CIHI) are sponsoring the investigation of the nationa hospita adverse events and errors to be pubished in ate Aso, Heath Canada is currenty funding an exporation of the possibiity of a nationa incident reporting system. The pubic-private roundtabe on patient organized by the Roya Coege of Physicians and Surgeons in September 2001 ed to the formation of the Nationa Steering Committee on Patient Safety (NSCPS) which has made 19 recommendations for a nationa integrated strategy aong five themes (see tabe 2). 33 These recommendations are simiar to those made by Baker and Norton in their systematic review and report to Heath Canada. 34 In February 2003 the Canadian Federa Budget earmarked $50 Qua Saf Heath Care: first pubished as /qshc on 2 June Downoaded from on 23 August 2018 by guest. Protected by copyright.

3 228 Arah, Kazinga Tabe 2 Current objectives and activities of nationa agencies in four deveoped countries UK 25 Canada Austraia USA Nationa Patient Safety Agency Nationa reporting and earning system (NRLS, aunched 2004) Deveoping patient reporting Root cause anaysis of incidents Promote open and fair NHS cuture for discosure and earning Active system support for staff Estabishing nationa patient priorities Researching and deveoping nationa soutions Partnering with NHS organizations to ensure reporting, earning and action In summary, ensuring that the NHS has memory and is safer Recommendations of the Nationa Steering Committee on Patient Safety Estabishing a Canadian Patient Safety Institute (CPSI) Lega and reguatory processes Measurement and evauation Continuing education and professiona deveopment processes Improving information and communication processes Recommendations of the Baker and Norton report Better nationa and provincia reporting systems; systems impementation Buiding awareness and setting priorities Skis and knowedge deveopment Supporting efforts at organizationa and poicy eves Heath Canada Providing nationa eadership, and coordination of territoria/ provincia patient initiatives Impementing the nationa quaity and agenda Commissioning research Deveoping the Canadian Medication Incident Reporting and Prevention System (CMIRPS) miion over 5 years for the creation of a Canadian Patient Safety Agency. The Institute for Safe Medication Practices (ISMP Canada) is an independent not-for-profit body that promotes safe medication practices, coects and anayzes medication errors, and recommends improvements. 35 Austraia The Commonweath Department of Heath funded, in 1994, the Quaity in Austraian Heath Care Study (QAHCS) to detai the degree of adverse events in Austraian hospitas Modeed on the Harvard Medica Practice Study in the US, the QAHCS 38 in June 1995 showed that 16.6% of admissions had adverse events of which 51% coud be preventabe. 38 This pubication attracted much attention, immediatey resuting in the Nationa Taskforce on Quaity in Austraian Heath Care which recommended increased funding and estabishment of a nationa organization for and quaity of care. The subsequent formation in October 1996 of a Nationa Expert Advisory Group on Safety and Quaity in Austraian Heathcare ed to the estabishment of the Austraian Counci for Safety and Quaity in Heath Care (ACSQHC) in It coordinates the nationa action and has so far made four reports to the Heath Ministers Other nationa efforts incude the Austraian Patient Safety Foundation (APSF) which deveoped the Austraian Incident Monitoring System and a cassification system for coding and reporting. 45 The Austraian initiatives served as Austraian Counci on Safety and Quaity in Heath Care Agency for Heathcare Research and Quaity Priority action areas Active research support and Supporting heathcare system workers for safer patient care knowedge generation on practices and contro Improving data and information Error reporting and anaysis Invoving heathcare consumers Effective technoogy for Redesigning systems of heathcare to faciitate a cuture of Training and education of students and professionas on systemic nature Buiding awareness and of errors understanding of Deveopment of quaity indicators e.g. patient indicators Buiding partnerships ocay, nationay and internationay Austraian Patient Safety Foundation Consumer support and education Incident reporting and incident monitoring aggregated from system-wide heath units Coordinating the Austraian Incident Monitoring System Maintaining the Generic Occurrence Cassification TM for coding and reporting incidents and adverse events With usefu input from communication with persons representing these organizations as isted in the acknowedgements. Nationa Patient Safety Foundation Identifying and creating a core body of knowedge Identifying pathways to appy the knowedge Deveoping and enhancing the cuture of receptivity to patient Raising pubic awareness and foster communications about patient Joint Commission on Accreditation of Heathcare Organizations Reducing sentine events Achieving shift in heath care cuture for proactive risk reduction Improving pubic confidence in the US heath care system Supporting activities to achieve core goas, (e.g. standards and safe practices deveopment, consumer campaigns, patient pubications, education) the tempate upon which the US and UK buit simiar agencies. USA The Institute of Medicine s (IOM) report To Err is Human 5 is probaby the most strategic pubication on patient in the US. This report put deaths from medica error in the US at about per annum, with 7000 of these resuting from medication errors aone. Estabished within 3 months of the IOM report, the Quaity Interagency Coordination Task Force (QuIC) recommended some 100 actions to improve. 46 The Agency for Heath Care Research and Quaity (AHRQ) oversees the federa government s interests in 47 (tabes 1 and 2). AHRQ sponsored the Stanford University Evidenced Practice Center and the University of Caifornia to produce a critica appraisa of evidence on practices 48 and the AHRQ patient indicators (as part of the three-part AHRQ Quaity Indicators project). 49 The Joint Commission on Accreditation of Heathcare Organizations (JCAHO), as an independent accrediting organization, has patient requirements for hospitas which it accredits. 50 The Nationa Patient Safety Foundation (NPSF) aims to ead the transition from a cuture of bame to that of. 51 MedMARX is a medication error reporting program of the US Pharmacopoeia to share experiences and best quaity practices. 52 Other notabe nationa or widespread initiatives are from the Institute for Safe Medication Practice 53 (ISMP, a Qua Saf Heath Care: first pubished as /qshc on 2 June Downoaded from on 23 August 2018 by guest. Protected by copyright.

4 How safe is the paradigm? 229 Tabe 3 Current Canadian and Austraian nationa patient indicators and their properties Indicator topic Numerator Canada 60 Austraia 61 Hip fracture hospitaization Age standardized acute care hospitaization rate for fracture of the hip per (ICD-9 or ICD- 9-CM diagnosis code of , 820.8, 820.9) Denominator Popuation aged 65 and oder Source of Canadian Institute for data Heath Information; Hospita Morbidity Database Target and system eve Drawback Latest empirica average Safety issues in ong term care faciities; hospitas and heath system May represent readmissions or case transfers; may overestimate incidence of hip fractures; hip fractures can occur independent of system 575 per À (95% CI: per for year ) Hospita separations with an adverse event Hospita separations* with an adverse event by an externa cause group (e.g. misadventures, compications and adverse drug events Tota annua hospita separations Nationa Hospita Morbidity Database (NHMD) Safety in medication; surgica and medica care; hospitas Data may contain misabeed cases (e.g. poisonings) not reated to adverse events ` * Separation refers to an episode of care such as a tota hospita stay (from admission to transfer, discharge, or death) or part of a hospita stay invoving care change (e.g. from acute to rehabiitation). À `Tota number of hospita separations with adverse events in representing 4.8% of tota separations. not-for-profit agency that educates professionas or institutions on adverse events and runs a nationa Medication Errors Reporting Program with the US Pharmacopoeia), the Food and Drug Administration (with its vountary MedWatch reporting system), 54 the vountary Nationa Nosocomia Infection Survey of the Centers for the Disease Contro and Prevention, 55 and the Nationa Quaity Forum. SAFETY RELATED PERFORMANCE INDICATORS The deveopment and the use of indicators within conceptua frameworks are major ways through which nationa governments drive performance improvement in their heath systems The Canadian 60 and Austraian 61 heath system performance frameworks have one indicator each for patient admission to hospita for hip fracture and hospita separations with an adverse event, respectivey. Tabe 3 summarizes these two indicators. However, the ACSQHC aso has sentine events indicators which were approved by the Austraian Heath Ministers and which represent binomia catastrophic events of system faiure deemed suitabe for nationa aggregation. The US (AHRQ) probaby has the most comprehensive set of indicators on patient. 49 The AHRQ patient indicators (PSIs) represent a major undertaking to screen, at provider or system eve, patient issues using hospita administrative data. These indicators with empirica averages ranging from four transfusion reactions per miion discharges at risk to obstetric traumas in 1000 vagina deiveries with instrumentation cover surgica, obstetric and medica conditions, risk adjusted for age, sex, diagnosis reated group, and comorbidity categories 49 (see tabe 4 for an overview). The Canadian Institute for Heath Information has aso adopted the AHRQ indicators. Other indicator systems in the USA incude the JCAHO Indicator Measurement System for infection contro and the JCAHO sentine events. Tabe 4 Patient indicators of the US Agency for Heathcare Research and Quaity 49 Indicator topic Compications of anesthesia Death in ow mortaity DRGs Empirica average* Drawback 0.55 Definition varies; underreporting; unspecific denominator; unknown vaidity 0.66 Mixed severity; no pubished evidence of expicit process and staffing construct vaidity Decubitus ucer 21.5 Mixed severity; case mix bias; underreporting; conficting vaidity evidence Faiure to rescue May be unpreventabe; mixed severity; perverse infuence Foreign body eft during procedure 0.09 Non-specific denominator; rare; needs stratification Iatrogenic pneumothorax 0.67 Non-specific denominator; unknown vaidity Seected infections due to medica care 1.99 Perverse infuence; underreporting hemorrhage or hematoma hip fracture physioogica and metaboic derangement pumonary emboism or deep venous thrombosis respiratory faiure 2.06 Case mix bias; non-specific denominator; needs stratification 0.80 Case mix bias; non-specific denominator 0.89 Definition may vary; no pubished construct vaidity evidence 9.19 Needs stratification; may be underreported 3.59 Case mix bias; event may be unavoidabe sepsis Definition may vary; perverse effects; uncear construct vaidity wound dehiscence 1.93 Case mix bias; uncear construct vaidity evidence Accidenta puncture or aceration 3.29 Underreporting; may be unpreventabe Transfusion reaction Rare; needs stratification; unknown vaidity Birth trauma (injury to neonate) 6.67 Definition may vary; mixed severity; uncear construct vaidity Obstetric trauma (Cesarean deivery) 5.93 Case mix bias; may be unpreventabe; uncear construct vaidity Obstetric trauma (vagina deivery with instrument) Obstetric trauma (vagina deivery without instrument ) Case mix bias; may be unpreventabe; uncear construct vaidity Case mix bias; may be unpreventabe; uncear construct vaidity *Per 1000 popuation at risk; represents the average performance for a nationwide sampe of hospitas. Obtained from AHRQ anaysis using the 2000 Heathcare Cost and Utiization Project (HCUP) State Inpatient Database (SID) for 29 states. Risk adjusted for age, sex, diagnosis reated group (DRG), and comorbidity categories. DISCUSSION This paper has expored briefy the nationa initiatives in four advanced heath systems. The use of patient agencies, incident reporting and earning systems, and indicators to address patient concerns is emerging. There are far more initiatives in use than can be highighted in this paper, but this review gives a snapshot of the nationa eve agenda. The benefits of such programmatic efforts are assumed, so we wi not discuss them here. The focus here is on their disadvantages. In rushing to do something about errors in medicine, countries must concurrenty critique what they are doing given the wide range of ideas and toos being depoyed and the potentia for these to become part of accountabiity mechanisms. Surey societies cannot afford to wait for evidence of faiure of these efforts before addressing them. We first discuss the Qua Saf Heath Care: first pubished as /qshc on 2 June Downoaded from on 23 August 2018 by guest. Protected by copyright.

5 230 Arah, Kazinga agencies and reporting systems together, and then the indicators. It is important to note that the different institutiona approaches to are reated to the differences in the structure and contro of the various heath systems. For instance, the puraistic US heath system is, as woud be expected, characterized by more bodies than is the case in a more uniform system such as the UK NHS (see tabe 1). Safety agencies and adverse event reporting systems Foreseeabe disadvantages of existing agencies and adverse event reporting systems seem to stem from them being too many, too vague, too narrowy focused, threatened by the medica practice environment, and too optimistic. Too many The organizations and reporting systems appear too many and may impose confusion and excessive reguatory burden on heath actors. This overcrowding of the performance environment 58 has been discussed in the case of NHS reguation. 62 Ineffective extraneous reguation and bureaucracy sow innovation. Professionas may become risk averse, innovate ess, and potentiay decrease overa cinica effectiveness (because when patients are not treated, they avoid harm but they aso ose out in gaining any benefits). The practice of medicine, as we know it, is an art and can be a risky venture for a invoved. No two patients are identica nor are any two errors. Even in this era of cinica guideines, medica intricacies impy that professiona providers wi be innovative. Innovation is the backbone of earning and growth, offering reative advantage over the status quo. 63 Too vague There are many definitions 51 and concepts of patient which risk making the core notions vague. The specifications, nature, and usefuness of toos used for reporting and earning from incidents are argey dependent on these sti poory aigned terminoogy and subjective conceptuaizations. This makes room for unfortunate mix ups and wrong anaysis. There are debates on whether shoud focus on medica injuries 64 or errors. 65 Furthermore, and effectiveness as dimensions of performance appear to overap when we incude errors of omission within. For emphasis and action, errors of omission deserve to be separated out as issues, especiay since not doing the right thing is not ony ineffective, but aso harmfu when the wrong thing is done instead. Too narrowy focused Athough this paper examines patient initiatives, it is evident that current efforts focus too narrowy on the patient with itte expicit inkage to wider aspects of heath system. Risk management entais reducing harm not just to patients but aso to staff, visitors, 3 and the environment (incuding the society). Many nationa initiatives try to address a these, abeit disjointedy. Furthermore, as shown in tabes 3 and 4, staff and environmenta measures are not currenty captured in performance frameworks. Obviousy, heath systems cannot treat these other aspects as independent concerns. Threatened by the medica practice environment The medica practice environment remains prohibitivey itigious. The current paradigm does not seem to be winning against the tort system and apportioning of bame. Espousing a no-faut rationae in the pubic domain, whie the bame cuture rages, has done itte to stem the itigation tide. Nor has the current approach to cuture (restricted to the heath and ega systems) heped. As in the wider quaity movement, vountary discosure and partia openness further undermine these efforts Too optimistic Current thinking on patient refects a zero toerance of harm. With abundant referencing to the aviation and other industries, and from quaity management cyces to cognitive meta-systems, 69 research has enabed heath systems to adopt systems engineering and causa anaytica rationaes and toos from the non-medica word. Where these aied and industria sectors have estabished nets, expected minimums, and unavoidabe maximums, medicine has no acceptabe eves of adverse events and errors, nor shoud it. A practica approach so far has been to fight the frequency and severity of adverse events to the barest eves possibe. An obvious disadvantage is that we become too hopefu in the short to medium term but disenchanted in the ong term when we get mixed resuts. In the absence of exhaustive data on the apses and of evidence of what works and what does not, our zero toerance may remain naivey optimistic. Safety indicators Even at a nationa headine eve, just reporting on hip fracture as seen in the Canadian heath indicators framework wi not give a baanced view of heath care (tabe 3). The US AHRQ indicators are more extensive but suffer from the shortcomings reated to administrative data, underreporting, indicator definitions, and preventabiity of the prescribed conditions (see tabe 4). 70 Their use of hospita administrative data imports the probems of incompete data and inaccurate and variabe coding of ICD-9-CM (Internationa Cassification of Diseases, 9 th edition, Cinica Modification) diagnosis fieds. 71 Aso, the ICD-9-CM coding system was not created with issues in mind and is therefore inadequate for identifying errors and injuries. 72 Basing toos on administrative data increases the ikeihood of ow sensitivity of these indicators in fagging incidents. 73 Athough much has been done to increase the vaidity and reiabiity of the AHRQ performance indicators, there is sti a ong way to go. Combining anesthetic compications together into one measure is ceary counterproductive as the tota count may stabiize whie the constituent conditions vary tremendousy. In addition, the AHRQ performance indicators specify medica conditions ess than they do surgica probems. Consequenty, these indicators wi be more probematic than other quaity measures among end users. Given the itigious medica practice environment, such ambiguities are unhepfu, if not unsafe. What can be done? Countries can and shoud strive towards evidence based. The issues raised above wi need to be addressed to create re-prioritized, coherent, deeper, more focused, and reaistic initiatives with an encouraging medicoega environment. This re-prioritization shoud earn from estabished approaches used in evidence based medicine and rationa decision making. Safety poicies shoud invest more in issues with the argest impact and conduct a better search for more rigorous evidence of effectiveness. By investing more, both financiay and otherwise, countries must criticay: N avoid useess and potentiay harmfu dupication of initiatives or systems; N carify and unify concepts and definitions; N expand and integrate the scope of within and beyond the heath system; Qua Saf Heath Care: first pubished as /qshc on 2 June Downoaded from on 23 August 2018 by guest. Protected by copyright.

6 How safe is the paradigm? 231 Key messages N Heath system has recenty become an urgent issue in many industriaized nations, notaby, UK, Canada, Austraia and USA. N These countries have a engaged in initiatives such as patient agencies, adverse event reporting and earning systems, and the use of performance indicators. N The benefits of such programmatic efforts are assumed, but it is sti uncear how effective these mutipe initiatives are. Furthermore, itte attention has been paid to their potentia side effects. N These shortcomings which can exacerbate the initia and heath probems shoud be anticipated and guarded against from the outset, especiay as these initiatives can become accountabiity toos. N Both effects and side effects of current initiatives need carefu rigorous evauation to achieve evidence based in heath systems. N address the poicies and societa environment which hinder the inception of a cuture of, fairness. and openness with the wider society; redesign the training and working conditions of providers; N engage patients and their famiies as partners in heath; and N search for better data sets and coding system for indicators as we as re-evauate the preventabiity of measured conditions. CONCLUSIONS Ensuring of heath systems has ed to the creation of agencies, networks, and poicies that may we become new bureaucracies and reguatory mechanisms, and may discourage earning and growth when they overburden professionas with new jargons, new protocos, and new responsibiities. Providers, who must work with patients as partners, are the key to any system redesign to confront patient [I]gnoring the occasiona need for innovation can ead to robot-ike execution of procedures in an unthinking, unrefecting manner which is surey not in the best interest of the patient. 75 Furthermore, as other countries adopt these patient modes which become part of nationa accountabiity and performance frameworks, it is imperative to expore their transferabiity and to find out how such efforts actuay affect the cuture, structures, practices, and outcomes. Contextua anaysis is indispensabe for successfu appication, acceptance, and appraisa of toos. 76 It is not enough to investigate whether these systems work; it is imperative to find out how and why they reduce errors and adverse events. We argue that, when it comes to routine surveiance or performance measurement using indicators or both, performers become what they measure or are expected to deiver. How effective these initiatives become depends on how we they are embedded in the medica cuture, structures, and poicies which promote effective patient centred care. As avoiding harm has been a fundamenta tenet of medicine since Hippocrates, we shoud remember to baance the doing no harm () with doing good (effectiveness or quaity heath care) at the eve of both the individua patient and the heath system. ACKNOWLEDGEMENTS The views in this artice are entirey those of the authors. No officia endorsements by the various institutions or affiiated persons are intended or shoud be inferred. The authors are gratefu to the foowing for information on their respective organizations or countries: Lucy Boton (Nationa Patient Safety Agency, UK), Pierrete Leonard (Roya Coege of Physicians and Surgeons of Canada), Heen McEroy and Michekke Budak (Heath Canada), Mark Bisby (Canadian Institutes for Heath Research), Barbara Levings (Austraian Counci for Safety and Quaity in Heath Care), Deborah Queenan (Agency for Heathcare Research and Quaity, USA), and Richard J. Croteau (Joint Commisison on Accreditation of Heathcare Organizations, USA).... Authors affiiations O A Arah, Netherands Institute for Heath Sciences, Erasmus MC, University Medica Center Rotterdam, Rotterdam, The Netherands O A Arah, N S Kazinga, Department of Socia Medicine, Division of Cinica Methods and Pubic Heath, Academic Medica Center, University of Amsterdam, Amsterdam, The Netherands Funding: Ministry of Heath, Wefare and Sport, The Hague, the Netherands. REFERENCES 1 McGynn EA, Brook RH. 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