Volume 172 Issue 2

Research Hepatitis C virus antibody prevalence among injecting drug users at selected needle and syringe programs in Australia, 1995-1997 Margaret A MacDonald, Alex D Wodak, Kate A Dolan, Ingrid van Beek, Philip H Cunningham, and John M Kaldor, for the Collaboration of Australian NSPs* MJA 2000; 172: 57-61 For editorial comment see Watson Abstract - Introduction - Method - Results - Discussion - Acknowledgements - References - Authors' details - - More articles on Infectious diseases and parasitology Abstract Objectives: To describe point prevalence of HCV antibody and relevant risk behaviour among people who inject drugs and who attended selected needle and syringe programs throughout Australia in 1995, 1996 and 1997. Design and setting: Repeated cross-sectional surveys of one week's duration were carried out in 21, 20 and 23 needle and syringe program sites throughout Australia in 1995, 1996 and 1997, respectively. Participants: All clients attending participating sites during the designated survey week were asked to complete a self-administered questionnaire and provide a finger-prick blood sample for HCV antibody testing. Main outcome measures: Prevalence of HCV antibody. Results:Survey response was 41% (n = 979) in 1995, 51% (n = 1463) in 1996 and 48% (n = 1699) in 1997. HCV prevalence declined significantly from 63% in 1995 to 51% in 1996 and 50% in 1997 (P < 0.001). Among respondents who reported injecting for less than three years, prevalence declined from 22% in 1995 to 13% in 1996 and 1997 (P < 0.001). Reported use of needles and syringes after someone else in the previous month declined from 31% in 1995 and 28% in 1996 to 15% in 1997 (P < 0.001). Conclusions: Despite an apparent decline in HCV prevalence, carriage rates of HCV antibody remain high. Introduction Hepatitis C virus (HCV) infection is predominantly spread through blood contact.1 In most First World countries, most prevalent and incident cases of HCV infection involve people who have, at some time, illicitly injected drugs. In such people, transmission is believed to occur predominantly through sharing of injecting equipment.2 HCV infection is a public health concern because of its serious complications, such as cirrhosis of the liver and hepatocellular carcinoma,3 as well as its high prevalence, long latent period and high probability of long-term carriage and infectiousness. Australia adopted a harm reduction approach as part of its national drug strategy in 1985.4 An extensive network of needle and syringe programs (NSPs) has been established in Australia; in the financial year 1994-95, around 700 NSPs distributed six million syringes nationally and an additional four million were distributed through pharmacies.5 Early and vigorous implementation of harm reduction measures, such as methadone maintenance, peer-based education and NSPs, has successfully maintained low seroprevalence of HIV infection among people who inject drugs in Australia.6 In contrast, prevalence and incidence of HCV infection among this population remain high.2,7 To assess the impact of prevention activities on HIV and HCV infection, a monitoring system was established at selected NSPs throughout Australia.6 Cross-sectional surveys at NSPs among people who inject drugs offer a practical and repeatable mechanism for recruiting large samples of injecting drug users. This provides a basis for systematic monitoring of HCV and HIV infection, and of injecting behaviours associated with transmission of these viruses. We report the results of the first three years of national HCV monitoring among NSP attenders in Australia. Methods The survey methods have been described in detail previously.6 Briefly, trained staff at participating NSPs asked all clients attending during one-week periods in March 1995, June 1996 and October 1997 to complete a brief, self-administered questionnaire and provide a finger-prick blood sample. Participating NSP sites were selected for number of attendances and coverage of all Australian States and Territories (see Box 1). Those selected in 1995 distributed approximately 40% of the syringes distributed nationally through NSPs. There was some change in sites over the three years because the number of NSPs increased, but a core group of 16 sites was maintained. Sex and age group were recorded for all clients who attended participating sites during the survey week. As some clients attended more than once, a record was kept as to whether the attendance was the first for that week to measure survey response rate. Participants completed a brief questionnaire on basic demographic characteristics and injecting and sexual behaviour. Capillary blood was collected on blotting paper by finger prick with single-use lancets. Venous blood was not obtained, as few NSPs had appropriate facilities for collecting and storing large amounts of blood. Specimens were tested for HCV antibody by a modified third-generation enzyme immunoassay (Abbott HCV 3.0, Chicago, USA). A modified cutoff value for optical density was calculated to capture more than 95% of the seronegative population. Specimens were considered positive for HCV antibody if the optical density to cutoff ratio was greater than or equal to one on initial and subsequent testing. In 1998, as a quality control measure, 60 samples were randomly selected from each year's survey and retested for HCV antibody as described. Retest results were 100% concordant for the 1995 and 1997 surveys but only 88% for 1996. Subsequently, all available stored 1996 samples (83%) were retested. Ethical approval for this study was obtained from relevant ethics committees associated with the investigators and with participating sites. Statstical analysis Data were analysed with the Stata computer package.8 We assessed change in demographic, behavioural or serological variables using the χ2 test for categorical variables and the Kruskal-Wallis or Mann-Whitney tests for discrete variables. To control for changes in sample characteristics between surveys, we assessed change in HCV prevalence from 1995 to 1997 for all participants, and, for participants who reported only one or two years of drug injection, by multivariate logistic regression analysis. We also used multivariate logistic regression analysis, restricted to sites that participated in all surveys, to assess change in HCV prevalence. Associations between HCV prevalence and participants' characteristics were evaluated by the χ2 test and χ2 test for linear trend. To control for intralaboratory variation with HCV antibody tests, we calculated HCV prevalence for 1996 participants using retested results where available. In addition, for participants with insufficient stored sera for retesting, the original estimates of HCV prevalence were adjusted for each category of variables used in the analysis, by the overall difference between original and retest test results. Associations between HCV prevalence and participants' characteristics in 1997 were also assessed using multivariate logistic regression. Factors significantly associated with HCV infection on univariate analysis (with an inclusion criterion of P ≤ 0.05) or factors that were considered a priori to be predictors of HCV risk were included in the logistic regression model. Results Characteristics of respondents As shown in Box 1, 979 clients in 1995, 1463 in 1996 and 1699 in 1997 completed a questionnaire and provided a blood sample suitable for HCV antibody testing, giving overall response rates of 41%, 51% and 48%, respectively. There was a higher response rate among clients aged less than 25 years compared with those aged 25 years or more in 1996 (56% v. 49%), but no difference in 1995 and 1997. There was a higher response rate among females than males in 1995 (46% v. 39%) and 1997 (63% v. 39%). The age ranges for respondents in the three years were 14-54 years in 1995, 13-53 years in 1996 and 15-58 years in 1997. The median age of respondents was significantly higher in 1995 than in 1996 (29 years v. 28 years; P = 0.009) and 1997 (29 years v. 27 years; P < 0.001). Median age at commencement of injecting drug use was 18 years in the three surveys. Consequently, the median number of years that respondents had injected drugs was significantly higher in 1995 than in 1996 (10 years v. 8 years; P = 0.001) and 1997 (10 years v. 7 years; P < 0.001). Similar proportions of males (65%, 67% and 66%), respondents reporting being heterosexual (79%, 78% and 79%), and those reporting having been imprisoned in the past year (15%, 13% and 14%) participated in the 1995, 1996 and 1997 surveys. Almost a third of respondents in each year reported no contact with health services such as counselling, detoxification or methadone maintenance treatment. The proportion of respondents on methadone treatment, however, was significantly lower in 1997 (33%) than in 1995 (40%; P = 0.001) or 1996 (36%; P = 0.02). More respondents reported that heroin was the last drug they injected in 1996 and 1997 than in 1995 (53% and 56% v. 44%) and fewer reported last injecting amphetamines (19% and 18% v. 21%) and methadone (12% and 11% v. 19%; P < 0.001). Daily or more frequent injection increased from 41% of respondents in 1995 and 1996 to 51% in 1997 (P = <0.001). Syringe use after someone else Reported use of a needle and syringe after someone else in the preceding month declined significantly from 1995 and 1996 to 1997 (31%, 28%, and 15%, respectively; P < 0.001). This practice was significantly more common among females than males in 1995 and 1997 (35% v. 28% and 17% v. 14%; P = 0.04). In 1997, respondents aged less than 25 years were more likely than older respondents to report syringe use after someone else in the past month (19% v. 12%; P = 0.001). HCV antibody prevalence Box 2 shows that HCV antibody prevalence was significantly lower in 1996 and 1997 than in 1995 (51% and 50% v. 63%; P < 0.001). This difference remained significant after adjustment for differences in sample characteristics between surveys (adjusted odds ratio, 0.5; 95% CI, 0.4-0.7). Sex, age, duration of drug injecting, last drug injected, frequency of drug injection and health service contact were included in the model. A similar pattern was found when analysis was restricted to the 16 sites that participated in all three surveys (63% in 1995 v. 50% in 1996 and 51% in 1997; P < 0.001) and when respondents who reported participation in more than one survey were excluded from the analysis (63% v. 49% and 47%; P < 0.001). HCV antibody prevalence was also significantly lower in 1996 and 1997 (13%) than in 1995 (22%) among respondents who reported less than three years of drug injection (P = 0.03). This difference also remained significant after adjustment for sex, age, last drug injected, frequency of drug injection and health service contact (adjusted odds ratio, 0.4; 95% CI, 0.2-0.7). HCV antibody prevalence was lower in 1996 and 1997 than in 1995 among respondents aged less than 25 years, regardless of whether the last drug injected was heroin (trend test, P = 0.03) or amphetamine (trend test, P = 0.002; Box 3a). Box 3b shows that, when respondents were grouped according to the year they started injecting, HCV antibody prevalence was higher among those reporting most recent injection of methadone or heroin than among those reporting most recent injection of amphetamine. HCV antibody prevalence was also significantly higher among respondents from New South Wales and Victoria than those from Queensland, and remained higher when the analysis was restricted to respondents reporting heroin as the last drug injected and stratified according to the year drug injection started (Box 3c). Multivariate logistic regression analysis showed that other factors significantly associated with presence of HCV antibody in 1997 included being female, having been imprisoned in the past year, having a history of methadone treatment, being aged 25 years or more, having injected drugs for more than five years, and daily or more frequent injection (see Box 2). Discussion Our findings indicate that HCV antibody prevalence, although high, is declining, particularly among participants new to injecting. While all cases of HCV infection among respondents who reported having injected for only one or two years cannot be classified as new infections, it is highly likely that the vast majority reflect recent transmission. Variation in the populations surveyed in the three years of the study cannot be excluded as an explanation for our observations. Respondents in 1997 were younger and newer to injecting than in 1995. Nonetheless, the decline in HCV antibody prevalence remained statistically significant when multivariate logistic regression analysis was used to control for differences in demographic characteristics, when analysis was restricted to respondents who reported less than three years of drug injection, and when analysis was restricted to sites that participated in all three surveys. It is also conceivable that HCV infection status influenced participation in the survey. For example, people infected with HCV might be more likely to participate than those not infected because of the services provided by NSPs or because they have an interest in blood-borne infections by virtue of having one. Alternatively, people with HCV infection might be reluctant to provide a blood sample in a non-clinical setting because of concerns about inadvertent spread of infection. It is not possible to determine whether people with HCV infection were more or less likely than those without infection to participate in the surveys. If such bias occurred it is unlikely that the direction changed from 1995 to 1996 and 1997. However, the extent to which the magnitude of such bias may have changed over the three surveys is not known. Comparison of our data with those of other Australian studies reporting HCV antibody prevalence according to type of drug injected and duration of injecting supports our observation that HCV antibody prevalence is declining among people who inject drugs. Among opiate injectors who had been injecting for less than three years, HCV antibody prevalence was 70% in the late 1980s9 and almost 50% in the early 1990s,10 compared with 20% in our study. Declining HCV antibody prevalence has also been reported from other cities that implemented HIV prevention measures in the mid-1980s, namely Geneva11 and Glasgow.12 We also found that the proportion of respondents who reported using a syringe after someone else was significantly lower in 1997 than in 1995 and 1996. There has been a marked decline in reported sharing of syringes in Australia since 1984, when more than 90% of respondents reported having done so in the month before interview.13 Of concern was the higher rate of sharing reported among respondents aged less than 25 years than among older respondents in 1997. Younger injecting drug users are probably more recent initiates to injecting; this is a subpopulation previously identified as being at extremely high risk of acquiring HCV infection.14 An extremely high incidence of HCV infection has also been reported recently among young people with a history of drug injecting in Sydney.7 It is difficult to explain the marked geographic variation in HCV antibody prevalence detected in our study. The sample recruited from Queensland was significantly different from other States and Territories with regard to known correlates of HCV infection such as duration of injecting and type of drug injected. Nonetheless, significantly lower prevalence persisted among respondents from Queensland compared with those from New South Wales and Victoria when the sample was stratified according to these factors. Despite our finding of declining HCV antibody prevalence among people who inject drugs in Australia, and even though an epidemic of HIV infection has so far been prevented, the prevalence and incidence of HCV infection in this group remain high.2,7 Percutaneous transmission is more efficient for HCV than for HIV infection.1 More importantly, the carriage rate of HCV among injecting drug users was already considerably higher than that for HIV when harm reduction policies were first introduced.9 It is likely that occasional instances of shared injection equipment and other blood contact during injection have been sufficient to maintain high levels of HCV transmission without an increase in HIV transmission. It can not be assumed that the results of our surveys are generalisable to all people who inject drugs in Australia. However, NSP clients represent a heterogeneous population of injecting drug users who are readily accessible for targeted prevention initiatives. Prevention efforts encompassing education, drug treatment and needle exchange need to be enhanced to improve consistency and coverage so that transmission of HCV infection is reduced further and the current low prevalence of HIV infection is sustained. * The Collaboration of Australian NSPs: ACT Drug Referral and Information Centre (Maureen Cane); AIDS Council of Central Australia (Sue Fielding); Australian IV League (Judith Byrne); Biala Alcohol & Drug Services (Margaret Holtham); Centre for Immunology, St Vincent's Hospital Sydney (Phillip Cunningham & Claire Temby); Clovelly Park, Norlunga, SAVIVE and Salisbury NSP, Adelaide; Drug Intervention Services Cabramatta (Sue Heard & Lisa Maher); GAIN (Richard Beckman & Diane Flint); Gold Coast Hospital (Dr Lynn Hawken); HIV and Sexual Health Services Cairns (Chris Barron & Mark Mills); Kirketon Road Centre & K2 (Dr Ingrid van Beek & Damian Hull); Macfarlane Burnet Centre for Medical Research (Dr Nick Crofts); Melbourne Inner Needle Exchange (Craig Mercer); Northern Rivers Health Service (Wendy Evans); Northern Territory AIDS Council (Charles Roberts); Resource & Education Program (IDU): Redfern & Canterbury (Julie Dixon & Anna Miraglia); St George NSP (Richard Sulovsky); St Kilda NSP (Simon Kroes); Sexual Health Services, Toowoomba (Bill Rutkin); SHARPS Melbourne (Sean Swift & Melissa Virtue); South Australian Drug and Alcohol Services Council (Dr Robert Ali & Bob Braithwaite); Tasmanian Council on AIDS and Related Diseases (Melinda Tonks); Tasmanian Users Health Support League (Stuart Williams); Wentworth NSP (Elizabeth O'Neil & Andy Hart); West Australian AIDS Council Inc. (Katrina Roberts & Samantha Nicholson); Western Australia Substance Users' Assoc. Inc. (Tamara Speed); Western Region AIDS and Hepatitis Prevention (Sandra Fox); Western Sydney AIDS Prevention Services: Harris Park & Blacktown (Anton Evers). Acknowledgements We acknowledge the contribution of survey participants, needle and syringe program staff and site coordinators who facilitated the surveys. We also thank Dr Greg Dore for his comments on earlier drafts. Surveys were funded by the Commonwealth Department of Health and Aged Care. The National Centre in HIV Epidemiology and Clinical Research is supported by the Commonwealth Department of Health and Aged Care through the Australian National Council on AIDS and Related Diseases and its Research Advisory Committee. References MacDonald M, Crofts N, Kaldor J. Transmission of hepatitis C virus: rates, routes and cofactors. Epidemiol Rev 1996; 18: 137-148. Crofts N, Jolley D, Kaldor J, et al. Epidemiology of hepatitis C virus infection among injecting drug users in Australia. J Epidemiol Community Health 1997; 51: 692-697. Seeff LB. Natural history of hepatitis C. Hepatol 1997; 3 Suppl: 21S-28S. Blewett N. National Campaign against drug abuse: Assumptions, arguments, and aspiration. Canberra: AGPS, 1987. (NCADA Monograph No. 1.) Wodak A, Lurie P. A tale of two countries: Attempts to control HIV among injecting drug users in Australia and the United States. J Drug Issues 1996; 27: 117-134. MacDonald M, Wodak A, Ali R, et al, on behalf of the Collaboration of Australian Needle Exchanges. HIV prevalence and risk behaviour in needle exchange attenders: a national study. Med J Aust 1997; 166: 237-240. van Beek I, Dwyer R, Dore GJ, et al. Infection with HIV and hepatitis C among injecting drug users in a prevention setting: retrospective cohort study. BMJ 1998; 317: 433-437. Stata Statistics/Data Analysis [computer program]. Version 5.0. Texas: Stata Corporation, 1997. Bell J, Batey RG, Farrell GC, et al. Hepatitis C virus in intravenous drug users. Med J Aust 1990; 153: 217-273. Crofts N, Hopper JL, Milner R, et al. Blood-borne virus infections among Australian injecting drug users: Implications for spread of HIV. European J Epidemiol 1994; 10: 687-694. Broers B, Junet C, Bourquin M, et al. Prevalence and incidence rate of HIV, hepatitis B and C among drug users on methadone maintenance treatment in Geneva between 1988 and 1995. AIDS 1998; 12: 2509-2066. Goldberg D, Cameron S, McMenamin J. Hepatitis C antibody prevalence among injecting drug users in Glasgow has fallen but remains high. Commun Dis Public Health 1998; 1: 95-97. Crofts N, Webb-Pullman J, Dolan K. An analysis of trends over time in social and behavioural factors related to the transmission of HIV among injecting drug users and prison inmates. Evaluation of the National HIV/AIDS Strategy 1993-94 to 1995-96. Technical Appendix 4. Canberra: AGPS, 1996. Garfein RS, Vlahov D, Galai N, et al. Viral infections in short-term injection drug users: the prevalence of hepatitis C, hepatitis B, human immunodeficiency, and human t-lymphotropic viruses. Am J Public Health 1996; 86: 655-661. (Received 1 Jun, accepted 16 Sep, 1999) Authors' details National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, NSW. Margaret A MacDonald, BSocSci, DipEpidemiol, Senior Research Assistant. John M Kaldor, PhD, Deputy Director. Alcohol and Drug Services, St Vincent's Hospital, Sydney, NSW. Alex D Wodak, FRACP, FAFPHM, Director. National Drug and Alcohol Research Centre, University of New South Wales, Sydney, NSW. Kate A Dolan, PhD, Senior Lecturer. Kirketon Road Centre, Sydney, NSW. Ingrid van Beek, MBA, FAFPHM, Director. Centre for Immunology, St Vincent's Hospital, Sydney, NSW. Philip H Cunningham, BAppSc, Senior Hospital Scientist. Reprints: Ms M A MacDonald, National Centre in HIV Epidemiology and Clinical Research, Level 2, 376 Victoria Street, Darlinghurst, NSW 2010. mmacdATnchecr.unsw.edu.au Make a comment Back to text 2: Hepatitis C virus antibody prevalence according to demographic and injecting characteristics (1995-1997), and multivariate logistic regression analysis (1997) 1995 1996 1997 CharacteristicNo. tested% with HCVNo. tested% with HCVNo. tested% with HCVAdjusted odds ratio (95% CI)Total979631463 51169950-Sex Male63963981 49‡111947*1 Female32764467 56574552 (1.5-2.7*)Imprisonment in previous year No82160*122448*145947*1 Yes14678190 71234702.3 (1.6-3.5*)Health service contact NSP only30032*483 17*53220*1 Detoxification, counselling12552 18338276351.4 (0.9-2.2) Past methadone maintenance15779 2657132570 3 (1.9-4.6*) Current methadone maintenance39584524 77563743.8 (2.5-5.8*) 1995 1996 1997 CharacteristicNo. tested% with HCVNo. tested% with HCVNo. tested% with HCVAdjusted odds ratio (95% CI)Age at survey (years) <206528*138 18*18419*1 20-2422639363 22440231.1 (0.6-1.9) 25-2919863308 50368471.9 (1.0-3.4‡) 30-3423775282 68290642 (1.0-3.8‡) 35+246 8436381414 845.7 (2.9-11.0*)Years of drug use <3131 22*24013*308 13*1 3-5165 3528521345 261.3 (0.8-2.1) 6-1020962309 51362442 (1.2-3.3†) >104568658081642 837.5 (4.4-13.0*)Last drug injected Amphetamine20635*274 22*31218*1 Heroin43167780 54951542.3 (1.4-3.7*) Combined drugs8572126 63104591.7 (0.8-3.5) Methadone18987169 82180783 (1.5-5.9†) Other6546109 45142462.1 (1.1-4.1‡) 1995 1996 1997 CharacteristicNo. tested% with HCVNo. tested% with HCVNo. tested% with HCVAdjusted odds ratio (95% CI)Frequency of drug injecting Less than daily50761†745 49†70741*1 Daily or more39968609 56867582 (1.5-2.7*) Not in last month704798 4111845-Syringe use after someone else in the last month No624 62†96850*1284491 Yes27971382 58220531.3 (0.9-2.0)State or Territory Queensland30940*490 33*47929*1 Victoria11853191 48436512.4 (1.6-3.5*) New South Wales41284497 71523702.2 (1.4-3.3*) Other14059285 50261461.6 (1.0-2.6‡)NSP=needle and syringe program. *P<0.001; †P<0.01 and >0.001; ‡P<0.05 and >0.01. Back to text 3: HCV antibody prevalence in relation to age, injecting habits and State or Territory. Back to text Back to text Back to text

Margaret A MacDonald · Alex D Wodak · Kate A Dolan · Philip H Cunningham

Clinical Update Out-of-hospital cardiac arrest Out-of-hospital cardiac arrest (OHCA), with its high fatality rate, is a significant public health issue. The aetiology of OHCA is reviewed, and management strategies are discussed, including the "chain of survival", the Utstein method of data collection, and recent developments in advanced cardiac life support emphasising defibrillation. Alastair D McR Meyer, Peter A Cameron, Karen L Smith and John J McNeil MJA 2000; 172: 73-76 Background - Recent advances in management of OHCA - Improving survival rates after OHCA in Australia - References - Authors' details - - More articles on Emergency medicine Out-of-hospital cardiac arrest (OHCA) is a leading cause of death in First World countries. The estimated incidence in the United States is about 1/1000 population per year (15%-20% of all deaths).1 Current Australian data based on ambulance attendances in metropolitan Melbourne suggest that about 2000 lives are lost from OHCA per year.2OHCA is often the first presentation of ischaemic heart disease. If victims of OHCA can receive immediate and appropriate treatment, they have a 30%-70% chance of survival.3 There is a paucity of data on survival from OHCA in Australia (Box 1). The Melbourne report of cardiac arrest victims mentioned above, which included all patients with arrhythmia of presumed cardiac cause, suggests that the survival rate may be as low as 3%.2 The management of OHCA is presently the only area of pre-hospital emergency care where there is clear evidence that appropriate intervention leads to improved survival.10 We present a clinical update on the management of OHCA. Background The usual cause of sudden cardiac death is coronary artery disease, which accounts for up to 90% of all victims;11 most have major pathological changes in two or more coronary arteries.11An arrhythmia is the most common cause of cardiac arrest, with ventricular fibrillation (VF) being more common12,13 than asystole, pulseless ventricular tachycardia (VT) and other arrhythmias. VF generally has a better prognosis than the other arrhythmias.12,13 Ischaemia, electrolyte imbalance, stress, and neurochemical transmitters (eg, adrenaline, noradrenaline), as well as clotting disorders (eg, massive pulmonary emboli), may trigger arrhythmia.12 VF rarely reverts spontaneously, and the definitive treatment is defibrillation.10 Hypoxic brain injury occurs at four minutes, and death will occur within 12 minutes if no therapy is offered.3,10 It has been predicted that with ideal pre-hospital care, survival rates would be of the order of 70%.3 Recent advances in management of OHCA The "chain of survival" Successful resuscitation of victims of OHCA depends on each individual's unique features (eg, prior medical condition, cardiac rhythm associated with the collapse, collapse witnessed or not witnessed), and the system in the community to deal with such problems. The system must provide a "chain of survival". This concept, initially described by Cummins et al in 1991, and adopted by the American Heart Association, focuses attention on four critical links in the resuscitation process of a victim of OHCA:14 Early recognition and access to emergency medical services Early cardiopulmonary resuscitation Early defibrillation Early advanced cardiac life support. Communities with integrated links along this chain have higher survival rates after OHCA than those with deficiencies in these links.15 Analysing emergency medical services (EMS) in different countries has been difficult, but, in 1990, an international Consensus Conference established uniform terms and definitions for out-of-hospital resuscitation.15 The Consensus Conference recommended that a template approach, the Utstein template, be used for reporting data from out-of-hospital resuscitations.16 This allows comparison and benchmarking between EMS in different countries (Box 2). Early access Recognition of cardiac arrest is often difficult, as it may be confused with fitting or fainting. Cardiac arrest is assumed in an unconscious patient who has no palpable pulse. Spontaneous breathing and pupil size are irrelevant to the diagnosis. Early access to EMS in Australia needs improvement. Two studies of OHCA found that bystanders do not know who to call and have trouble describing the victim.2,5 Education and training programs have been used to raise community awareness and response to OHCA. The "Phone first" campaign in rural Iowa (USA) decreased access times by over a minute. This simple campaign emphasised the need for citizens witnessing a collapse to call the EMS without delay.17 Early cardiopulmonary resuscitation (CPR) The available evidence shows that the earlier patients receive CPR, the greater their chance of survival.18-20For resuscitative efforts to be effective, the patient must be supine, and on a flat, firm surface. Chest compressions are performed in the lower part of the sternum, 4-6 cm in depth and at a rate of 80-100 compressions per minute. During cardiac arrest, properly performed chest compressions can produce systolic blood pressure peaks of 60-80 mmHg. Cardiac output is only 25%-30% of normal.21 Bystander CPR is seldom practised in Australia. Despite there being witnesses to 54% of OHCAs presenting as VF in the Melbourne report, only 22% received bystander CPR and it was often of questionable quality.2 Family members who witness their own relative's OHCA are less likely to perform CPR than a stranger who happens by a victim of OHCA in the street.22,23 Early defibrillation Defibrillation is the definitive treatment for VF.24 The chance of success deteriorates with each minute.3 Such is the importance of defibrillation that Wei and Tang have suggested the appropriate sequence to follow in resuscitation from cardiac arrest is D (defibrillation), C (circulation), B (breathing) and A (airway), rather than the more familiar ABC.25New technology has allowed defibrillators to become more user friendly. Automated external defibrillators (AEDs) can analyse patients' electrical rhythm and can proceed to deliver pre-programmed shocks without further decisions by the rescuer. These machines are simple to operate and are ideal for use by unskilled first responders. This technology is suitable for health clinics and general practitioners' surgeries.26 Members of the public may soon have access to such devices. In the United States, they have been deployed in public buildings, sporting venues and are carried by police. They have also been successfully used by family members of patients known to be at high risk of OHCA.26 New developments in the defibrillating shock may increase the efficacy and safety of defibrillation.26,27 Kerber et al have described a dual-pulse defibrillating shock.27 Different energy waveforms during defibrillation have been described by Bardy et al.28 A damped sinusoidal pattern is most often used for traditional transthoracic defibrillation. These authors have shown that during transthoracic defibrillation, a biphasic shock at 130 J is as effective as a (traditional) monophasic shock at 200 J. The shock also produces less myocardial injury and is potentially safer for bystander use.28 Current-based defibrillation is another promising alternative to traditional energy-based defibrillation. Current-based defibrillation requires the operator to select the electrical dose (amperes) rather than the energy (joules). In this way, delivery of low energy in the face of high transthoracic impedance is avoided. The defibrillator measures the transthoracic impedance, then delivers the exact current requested.26 Early advanced cardiac life support (ACLS) ACLS has traditionally been described as having three interventions: defibrillation, endotracheal intubation and intravenous medications. Defibrillation now stands alone as the single most vital intervention of resuscitation from OHCA, and must be delivered as early as possible. Consequently, it is now rightly the responsibility of primary responders. Endotracheal intubation Endotracheal intubation isolates the airway, keeps it patent, permits tracheal toileting, ensures delivery of a high concentration of oxygen and provides a route for administration of certain drugs. However, no randomised controlled studies have yet been published that demonstrate a significant survival difference with this intervention when compared with basic airway management.18 Intravenous medications Intravenous medications can be administered by a variety of routes (eg, central vein, peripheral vein). The ideal route for administering drugs to a patient in cardiac arrest is one which delivers the drug to the target organ, is simple and rapid to perform with minimal expertise, and has minimal complications. At present, no single route has all of these features.29 A large antecubital fossa vein is recommended for the initial intravenous access. Intravenous medications are discussed in Box 3. Improving survival rates after OHCA in Australia To improve the chance of surviving an OHCA in Australia, data must be collected according to the Utstein template. From this, all aspects of the "chain of survival" can be clearly studied and benchmarked, and developments such as public education programs and public access defibrillators can then be implemented and accurately evaluated (Box 4). Future modification of ACLS management protocols should only be made on the basis of controlled studies. References Becker LB, Smith DW, Rhodes KV. Incidence of cardiac arrest: a neglected factor in evaluating survival rates. Ann Emerg Med 1993; 22: 86-91. Bernard S. Outcome from prehospital cardiac arrest in Melbourne, Australia. Emerg Med 1998; 10: 25-29. Larson MP, Eisenberg MS, Cummins RO, et al. Predicting survival from out-of-hospital cardiac arrest. Ann Emerg Med 1993; 22: 1652-1658. Bett JHN. Experience with a mobile coronary care unit in Brisbane. Ann Emerg Med 1989; 18: 969-974. Jacobs IG, Oxer HF. A review of pre-hospital defibrillation by ambulance officers in Perth, Western Australia. Med J Aust 1990; 153: 662-664. Scott IA, Fitzgerald GJ. Early defibrillation in out-of-hospital sudden cardiac death: an Australian experience. Arch Emerg Med 1992; 10: 1-7. Brennan RJ, Luke C. Failed hospital resuscitation following out-of-hospital cardiac arrest: are further efforts in the emergency department warranted? Emerg Med 1995; 7: 131-138. Jackson T, Cameron PA. Prehospital defibrillation in Geelong. Emerg Med 1993; 5: 184-187. Sammel NL, Taylor K, Selig M, O'Rourke M. New South Wales intensive care ambulance system: outcome of patients with ventricular fibrillation. Med J Aust 1981; 2: 546-550. American Heart Association. Emergency Cardiac Care Committee and Subcommittees. Guidelines for cardiopulmonary resuscitation and emergency care. JAMA 1992; 268: 2171. Reichenbach DD, Moss NS, Meyer E. Pathology of the heart in sudden cardiac death. Am J Cardiol 1977; 39: 865. Eisenberg MS, Horwood BT, Cummins RO, et al. Cardiac arrest and resuscitation: a tale of 29 cities. Ann Emerg Med 1990; 19: 179-186. Eisenberg MS. Prehospital care. In: Skinner D, Swain A, Peyton R, Robertson C, editors. Cambridge textbook of accident and emergency medicine. Cambridge: Cambridge University Press, 1997: 288-298. Cummins RO, Ornato JP, Theis W, et al. Improving survival from cardiac arrest: the chain of survival concept. Circulation 1991; 83: 1832-1847. Cummins RO and Graves. Prehospital care II: European and American perspectives. In: Skinner D, Swain A, Peyton R, Robertson C, editors. Cambridge textbook of accident and emergency medicine. Cambridge University Press, 1977: 298-303. AHA Medical/Scientific Statement. Recommended Guidelines for Uniform Reporting of Data from Out-of-Hospital Cardiac Arrest: The Utstein Style. Circulation 1991; 84: 960-975. Montgomery WH, Brown DD, Hazinski MF, et al. Citizen response to cardiopulmonary emergencies. Ann Emerg Med 1993; 22: 428-434. Maguire JE. Advances in cardiac life support: sorting the science from the dogma. Emerg Med 1997; 9 Suppl: 1-8. Callahan M, Madsen CD. Relationship of timeliness of paramedic Advanced Life Support interventions to outcome in out-of hospital cardiac arrest treated by first responders with defibrillators. Ann Emerg Med 1996; 27: 638-648. Weaver WD, Cobb LA, Hallstrom AP, et al. Considerations for improving survival from out-of-hospital cardiac arrest. Ann Emerg Med 1986; 10: 1181-1186. Varon J, Marik PE, Fromm RE Jr. Cardiopulmonary resuscitation: a review for clinicians. Resuscitation 1998; 36: 133-145. De Vreede-Swagamakers JJ, Gorgels AP, Dubois-Arbouw WI, et al. Out of hospital cardiac arrest in the 1990s: a population-based study in the Maastricht area on incidence, characteristics and survival. J Am Coll Cardiol 1997; 30: 1500-1505. Jackson RE, Swor RA. Who gets bystander cardiopulmonary resuscitation in a witnessed arrest? Acad Emerg Med 1997; 4: 540-544. Pantridge JF, Geddes JS. A mobile intensive care unit in the management of myocardial infarction. Lancet 1967; 2: 271-273. Wei MH, Tang W. Science challenges the dogma of ACLS [editorial]. Chest 1996; 109: 597-598. Robertson CE, Nichol NM. Recent advances in defibrillation therapy. Curr Opin Crit Care 1997; 3: 214-217. Kerber RE, Spencer KT, Kallok MJ, et al. Overlapping sequential pulses: a new wave form for transthoracic defibrillation. Circulation 1994; 89: 2369-2379. Bardy GH, Marchlinski FE, Sharma AD, et al. Multicentre comparison of truncated biphasic shocks and standard damped sinewave monophasic shocks for transthoracic ventricular defibrillation. Circulation 1996; 94: 2508-2514. ALS Working Party of the ERC. Guidelines for advanced life support. Resuscitation 1992; 22: 191-195. Hapnes SA, Robertson CE. CPR-drug delivery routes and systems. Resuscitation 1992; 24: 137-142. Linder KH, Koster R. Vasopressor drugs during cardiopulmonary resuscitation. Resuscitation 1992; 24: 147-154. Stiell IG, Herbert PC, Weitzman BN, et al. High grade epinephrine in adult cardiac arrest. N Engl J Med 1992; 327: 1045-1049. Brown CG, Martin DR, Pepe PE, et al. A comparison of standard dose and high dose epinephrine in cardiac arrest outside hospital. N Engl J Med 1992; 327: 1051-1055. Callahan M, Madsen CD, Barton CW, et al. A randomised clinical trial of high dose epinephrine and norepinephrine and standard dose epinephrine in prehospital cardiac arrest. JAMA 1992; 268: 2667-2672. Woodhouse SP, Case C, Cox S, et al. Trial of large dose adrenaline vs placebo in cardiac arrest [abstract]. Resuscitation 1993; 25: 89. Woodhouse SP, Cox S, Boyd P, et al. High dose and standard dose adrenaline do not alter survival compared with placebo in cardiac arrest. Resuscitation 1995; 30: 243-249. Linder KH, Dirks B, Strohmenger HU, et al. Randomised comparison of epinephrine and vasopressin in patients with out-of-hospital ventricular fibrillation. Lancet 1997; 349: 535-537. Stahmer SA, Varon J, Fromm RE. Controversies in cardiopulmonary resuscitation pharmacotherapy. Hosp Physician 1994; 30: 23-30. Steedman DJ, Robertson CE. Acid-base changes in arterial and central venous blood during cardiopulmonary resuscitation. Arch Emerg Med 1990; 9: 169-176. Steuven HA, Thomson BM, Aprahamian C, et al. Calcium chloride: reassessment of use in asystole. Ann Emerg Med 1984; 13: 820-822. Authors' details Emergency Department, Royal Melbourne Hospital, Melbourne, VIC. Alastair D McR Meyer, BSc(Hons), MB BS, FACEM, Research Fellow in Emergency Medicine; and PhD Scholar, Department of Epidemiology and Preventive Medicine, Monash University. Peter A Cameron, MD, FACEM, Director of Emergency Medicine. Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC. Karen L Smith, BSc(Hons), GradDipEpiBiostats, PhD Scholar. John J McNeil, PhD, FRACP, Professor; and Head of Department. Reprints will not be available from the authors. Correspondence: Dr A D McR Meyer, Research Fellow in Emergency Medicine, Emergency Department, Royal Melbourne Hospital, Grattan Street, Parkville, VIC 3050. Make a comment 1: Survival from out-of-hospital cardiac arrest - Australian studies StudyPatients/presenting rhythmSurvival (%) to dischargeBett (1989)4 Ventricular fibrillation110 (9%)Jacobs and Oxer (1990)5Ventricular fibrillation231 (22%)*Scott and Fitzgerald (1992)6All patients with OHCA103 (17%)Brennan and Luke (1995)7All patients with presumed cardiac arrest, arriving at hospital274 (5%)Bernard (1998)2All OHCA victims, presumed cardiac cause, all rhythms 361 (3%)Jackson and Cameron (1993)8Ventricular fibrillation/pulseless ventricular tachycardia79 (18%)Sammel et al (1981)9Ventricular fibrillation/pulseless ventricular tachycardia434 (21%)*28 days after discharge. OHCA=Out-of-hospital cardiac arrest. Back to text 2: The Utstein Consensus Conference Two meetings in 1990 with representatives from the American Heart Association, the European Resuscitation Council, the Heart and Stroke Foundation of Canada, and the Australian Resuscitation Council: Established uniform terms and definitions for out-of-hospital resuscitation; Established a reporting template for resuscitation studies to ensure comparability; Defined time points and time intervals relating to cardiac resuscitation; Defined clinical items and outcomes that the emergency medical service should gather; and Developed guidelines for describing resuscitation systems. Back to text 3: Intravenous medications in early advanced cardiac life support Adrenaline Catecholamines, such as adrenaline and noradrenaline, are vasopressors and have long been used as adjuncts to improve the success rate in CPR. These catecholamines increase aortic diastolic pressure by producing arteriolar vasoconstriction and improve blood delivery to the central circulation. If exogenous catecholamines are administered, improved myocardial and cerebral perfusion occurs. The optimal dose range for humans in both the prehospital and hospital stage remains unclear.30 Three large North American multicentre trials have failed to show any benefit from the administration of high-dose adrenaline or noradrenaline in the prehospital or inhospital setting.31-33 The recommended dose is 1mg intravenously repeated at 2-3-minute intervals.34 There is evidence, however, that the use of adrenaline may make absolutely no difference to the outcome of VF cardiac arrest.35,36 Vasopressin There are encouraging results with the use of vasopressin in OHCA.37 In cardiac arrest of long duration, vasopressin seems to have greater efficacy in restoring spontaneous cardiovascular function compared with adrenaline alone.37 More evidence is required before this drug can be recommended. Antiarrhythmics There are many agents which have antiarrhythmic properties in patients with a cardiac output. However, the overwhelming evidence is that antiarrhythmic drug therapy has very little, if any, role to play in the treatment of OHCA.38 Acidaemia When cardiac arrest occurs, anaerobic metabolism occurs in tissues and this results in the production of large amounts of lactic and other organic acids. Good quality CPR and adequate alveolar ventilation limits the development of acidaemia.39 Significant falls in arterial pH do not occur for the first 20 minutes after cardiac arrest. Correction of the acidosis through measures other than ventilation and restoration of circulation has not been shown to improve outcome.38 Calcium Calcium ions play a role in myocardial contractility. A deficiency of calcium is associated with cardiac arrest. However, there is no benefit for the use of calcium in patients with asystole or VF.40 There may be some use for this agent in specific situations of pulseless electrical activity secondary to hyperkalaemia, calcium channel blocker overdose, or hypocalcaemia.40 Back to text 4: Strategies to improve survival from out-of-hospital cardiac arrest in Australia Improved education of the public and healthcare providers in recognising cardiac arrest and accessing emergency medical services (EMS) Improved training of laypersons in cardiopulmonary resuscitation Increased deployment of automatic external defibrillators Public access defibrillation Improved ambulance response times Improved data collection by the EMS throughout Australia Improved communication between units researching pre-hospital resuscitation An evidence-based approach to allocating resources for pre-hospital early advanced cardiac life support protocols Back to text

Peter A Cameron · Karen L Smith · John J McNeil

For Debate Risk management: how doctors, hospitals and MDOs can limit the costs of malpractice litigation Lionel L Wilson and Max Fulton MJA 2000; 172: 77-80 Introduction - What is risk management? - Current litigation environment - Medical defence organisations - Hospitals - What is effective risk management? - Conclusion - References - Authors' details - - More articles on Administration and health services Synopsis The concerns of doctors regarding their risk of malpractice litigation and the costs of indemnity premiums are resulting in calls for legal reforms to limit their liability. We do not believe these returns will be successful either practically or politically. Medical defence organisations often attempt to vindicate the doctor rather than settle the dispute -- a strategy that might be morally satisfying to doctors but which is also more expensive than the approach taken by commercial insurers. Risk management -- the activities required to minimise financial loss for hospitals and the doctors who work in them -- is disorganised or absent in most hospitals. Hospital managers lack incentives for risk management because the costs of litigation do not come out of their budgets. The five mainstays of effective risk management are credentialling of medical staff, incident monitoring and tracking, complaints monitoring and tracking, infection control, and documentation in the medical record. The implementation of risk management activities in hospitals is the immediate responsibility of hospital management, not doctors. IntroductionTypically, the response of the medical profession and the medical defence industry to what appears to be an ever-increasing problem with malpractice litigation and the consequent rise of indemnity premiums is to call for "tort reform" -- that is, changes in the legal system to limit the legal or financial exposure of doctors to tortious actions (in law, a "tort" is a breach of duty leading to a liability for damages). We believe that efforts to achieve limited liability are unlikely to succeed politically or in practice. Unless liability is capped at a level that would be unacceptable to the general public, capping will have little impact on indemnity funding, or insurance costs. For example, given that the value of over 99% of awards and settlements in medical cases is less than one million dollars, a cap of $5 million (which we believe would be the likely minimum rate anyone would consider as "fair") would be unlikely to have any substantive effect. We briefly describe the current professional indemnity environment and suggest actions that doctors, hospitals and mutual funds should consider if they wish to contain the escalating cost of professional negligence indemnity cover. What is risk management? We define risk management as the activities required to minimise financial loss for hospitals and the doctors who work in them.1In the literature there is much confusion between risk management and quality management.2 For our purposes, risk management is only concerned with avoiding patient harm as a means of minimising financial loss and not as an end in itself (unlike quality management). Other authors who recognise the commonality between risk management and quality management spend some time trying to clarify the relationship.3-5 Even if all adverse events (however defined) could be avoided, not all the costs of malpractice litigation would be eliminated. The Harvard Medical Practice Study6-8 found that while less than 2% of negligent injuries led to claims, over 80% of negligence claims were brought in cases in which there was no injury and no negligence.9 This means that, if the right risk management processes and systems are in place, hospitals and doctors should be able to rebut allegations of negligence in 80% of cases and successfully argue that no compensation payment should be made. Current litigation environment Anecdotal evidence suggests a rising tide of anxiety among doctors concerning their exposure to litigation and its costs, both financial and emotional. Many doctors perceive this increased risk as beyond their control and in the hands of others, in particular the judicial system and lawyers. As an example of the rise in compensation payouts, the current high water mark for awards in neurological damage cases is the Black v Lipovac case,10 in which the plaintiff was awarded over $7 million. When costs are added, the medical defence organisation concerned is estimated to have paid out over $10 million.11 In 1994 the highest amount awarded to a child with brain damage was only $2 million (Loo v Harbord Administration Pty Ltd). As for the rate of claims, statistics are very difficult to obtain, resulting in a debate as to whether it is actually increasing. In financial terms, hospitals are in an even more serious situation than doctors, although here again obtaining factual analysis of claims and judgements is extremely difficult, both for the public and private sectors. Australia is not alone in having these problems. Poor clinical risk management is estimated to cost the NHS in the UK some £100 million per annum and, with an increasingly litigious population, this figure is expected to rise sharply in coming years.12 Medical defence organisations (MDOs) Most doctors indemnify themselves against malpractice claims through membership of one of the MDOs. The remaining doctors either go without any indemnity cover or take professional indemnity insurance with a commercial insurer. The MDOs are "doctor organisations": non-profit societies governed by boards consisting mainly of medical practitioners. MDOs are underfunded Only in recent years have MDOs started to adopt the disciplines normally associated with commercial insurance companies, moving to establish wholly owned, authorised insurance companies and to introduce non-doctor, independent directors onto their boards. One sign of this has been the trend away from "discretionary cover" towards legally enforceable insurance contracts. There is still a way to go, and the way is further for some than for others. The MDOs' wholly owned, authorised insurance companies are fully funded and meet the prudential and solvency requirements laid down by Government for insurance companies. However, the MDOs themselves, which have historically provided discretionary cover, are underfunded. Ms Fiona Tito, in her Review of Professional Indemnity Arrangements for Health Care Professionals (commissioned by the Commonwealth Department of Health and published in 1994), assessed the (then) total underfunding at between $300 million and $400 million.13 Claims management Apart from the way MDOs report financially, nowhere is the difference between MDOs and insurance companies more apparent than in the way MDOs manage their members' claims. It seems that the underlying philosophy driving the dispute-settling process of MDOs is an implicit belief that:only doctors can truly understand medical issues, and if plaintiffs and their lawyers could only be made to understand what the doctors reviewing the claim understood about it they would drop the claim; the reason for most adverse events is not negligence by the doctor but the inherent complexities of medicine; as no doctor embarks upon a procedure with the purpose of harming a patient, in fact the very opposite, patients should be grateful for their efforts and not sue if something should go wrong. From this position on the moral high ground, MDOs have a tendency to be far more fixated on maintaining the "innocence" of the doctor (and the profession generally) than on opportunities for early settlement. In contrast, insurance companies are much more likely to be disinterested and pragmatic. More MDO cases are litigated, with settlements being left until later in the dispute resolution process. Often this means that MDOs pay out higher settlements than commercial insurance companies. Many doctors would see the approach taken by MDOs as laudable and correct. MDOs are, after all, non-profit mutual societies. We disagree. Irrespective of the stance taken at the beginning, the vast majority of cases ultimately settle, so why not settle as early as practicable? There is empirical evidence that insurers' legal costs and the average compensation payment are significantly higher in those organisations that are most ready to seek a litigated solution to disputes.14 Yet we are not aware of any MDO which has established an ongoing dispute-mediation program. If mediation is used at all, it is reactive, court-directed mediation, which is a case of "too little, too late". If an MDO pursues a high litigation strategy based on the premise that it is necessary to show plaintiff lawyers that the MDO is "not an easy touch", that strategy will generally be ineffective and will cost its members money. Medical input remains important in claims management, but it is not supreme. The processing and resolution of medical malpractice claims is a highly professional endeavour that should belong as much to the insurance and business world as it does to doctors. Failure to recognise this will only lead to a further escalation of costs and premiums. Hospitals The Tito Report highlighted the absence of effective risk management programs in hospitals (reference 13, page 295). In the past few years, efforts to improve risk management have been made by some public hospital authorities and by private sector groups, but this has not resulted in significant change at the individual hospital level. In the light of the level of claims against hospitals, it is difficult to explain why this is so, but we think the following reasons apply to most hospitals: hospital managers simply do not know what has to be done; or they know what to do but are not prepared to spend time and effort on implementation; or they know what to do but fear the political consequences of doing it; or they fear that the political price they will pay exceeds the costs of paying claims. Unfortunately, the lack of data on claims and judgements is still a serious barrier to analysing hospital and medical claims (reference 13, pages 13, 21). Using data provided by NSW Health, Wilson and Goldschmidt estimated that from 1981 to 1994 there was an average of more than one claim per year for every NSW public hospital (reference 1, pages 25-27). Data from the private sector are even more difficult to acquire. Most evidence is anecdotal, but points to a situation similar to that in public hospitals. For example, one large Australian insurer is refusing to renew any professional indemnity policies for private hospitals. Lack of drivers for change A "driver" is the term applied to incentives and sanctions built into any system. In most States, public hospitals have most of the costs of litigation met by State Treasury funds. As they do not have to meet these costs directly out of their own budgets, at least in the first instance, there is no incentive for public hospital managers to implement effective risk management and no sanctions if they do not. As far as risk management goes, the system in most States is devoid of effective drivers. Many hospitals in the private sector seem to be so fearful of offending their medical staff that they would sooner meet the cost of malpractice litigation or the rising cost of premiums than take steps to reduce risk. While this may be acceptable for some private hospitals, this attitude contributes to the overall increase of doctors' premiums for indemnity insurance. Most claims are settled out of court and generally a higher compensation burden falls on medical practitioners than on hospitals. In our view, when no formal risk management program is in place, the hospital should carry a greater proportion of the financial risk. Hospitals, not doctors, carry prime responsibility for risk management initiatives. Once public hospitals are faced with the full consequences of malpractice litigation, we believe a start will be made to implement effective risk management (reference 13, page 294). Both public and private hospitals should be compelled (by legislation if necessary) to make their statistics on malpractice claims available to the community (in a non-identifiable way) and to their medical staff. What is effective risk management? Five activities are the mainstay of effective risk management: Credentialling of medical staff Incident monitoring and tracking Complaints monitoring and tracking Infection control Documentation in the medical record. Credentialling of medical staff Credentialling, or delineation of clinical privileges of medical staff, is a formal process whereby the medical staff demonstrate competency in procedures, for which they are then given credentials by the hospital's governing body permitting them to perform those procedures in the hospital.15Credentialling should be separate from the appointment process and, if it is to be effective, it must be conducted annually and must be procedure-specific. Although many Australian hospitals claim to be conducting credentialling, we are unaware of any that do so to the level where it becomes an effective risk management tool. If conducted properly, credentialling is a complex undertaking, because it not only must be credible but also must be fair and free from bias or apparent bias. Achieving these ends demands a significant program, which must be planned and managed. To be effective and to prevent, or at least minimise, the possibility of a successful legal action against medical staff or the hospital as a result of the credentialling program, certain basic rules and proper process must be adhered to (see Box) (reference 1, pages 545-563). In spite of the concerns by many doctors about their legal privilege while conducting quality management activity, credentialling is the only aspect of quality management or risk management activity that, if not conducted in strict accordance with the principles listed in the Box, carries the risk of exposing doctors to legal consequences. The need for absolute observance of the terms of reference and the need for a formally structured process are paramount. Even in North America, where credentialling of medical staff has been an intrinsic element in hospital practice for most of this century, there is a recognised need to render credentialling more robust and effective.16,17 The Tito Report, and published material in the US, UK and Australia, strongly support detailed, robust credentialling.13,18-21 Incident monitoring Most Australian hospitals claim to engage in incident monitoring, and NSW Health, for example, collates incident reports from its hospitals. However, incident monitoring and analysis must be conducted as close to the workface as possible if activities to correct identified problems are to have any chance of being implemented. Several factors tend to diminish the practical benefit of incident monitoring as it is currently practised in Australian hospitals. There is no aggregation of incidents (which might be reported to the nursing, medical or hospital administration) within hospitals, and no pattern analysis (tracking). Finally, it is of no use monitoring incidents and conducting a pattern analysis if there is no internal hospital mechanism to correct problems that are identified. The reporting of incidents requires a non-judgemental and non-punitive attitude on the part of hospitals. Nursing staff, for example, will simply not report medication errors if they know that some punishment will follow.19,20 Complaints monitoring For the purposes of quality and risk management in hospitals, complaints must be handled promptly and effectively at the hospital level. In recent years, efforts have been made in several States to change the hospital culture and processes in handling complaints. Nevertheless, it is still all too common for complaints to hospitals to be met by a wall of silence and obstruction. It is still unusual for the hospital manager to become directly involved at an early stage. The patient and family readily see that they are being put off, and this increases the risk that they will become angry, aggrieved and litigious. Hospitals should have a complaints mechanism and a complaints-resolution procedure in place and the hospital manager should play a prominent and early role in this process. Hospitals should have a policy and a mechanism to advise all patients how to make a complaint and such information should be prominently displayed. The recent innovation of patient advocates is a positive step. The monitoring and analysis of complaints becomes a valuable risk management tool. Infection control Infection control is an example of surveillance, the monitoring of one aspect of care. In today's hospital environment, it becomes a vital piece of the risk management strategy. Infection control in most Australian hospitals is generally considered to be well developed. However, like credentialling, it is often not sufficiently rigorous to be an effective risk management tool. Documentation of the medical record Nothing causes doctors and hospitals more medicolegal angst than inadequacies in the medical record. Every case that has to be settled out of court because inadequate documentation precluded an effective defence means a rise in doctors' indemnity premiums. Anecdotal accounts all confirm that the adequacy of medical records in Australia varies widely within the same hospital and from hospital to hospital. In a case that may have far-reaching implications for doctors and hospitals alike, Australian Capital Territory Health Authority v Moorby (unreported, NSW Court of Appeal, 25 June 1997 -- CLS 1997 NSWCA 94), the court applied the doctrine of res ipsa loquitur ("the fact speaks for itself") for the first time in an Australian medical negligence case, finding negligence in the absence of any persuasive explanation for the adverse result which left a healthy 17-year-old severely brain damaged. One of the reasons why the court was able to find as it did was the absence of adequate medical notes. Hospitals should train interns, residents and, if necessary, even visiting medical officers in the requirements for good documentation to reduce the risk of litigation, even if not for the sake of quality of care. The expenditure involved would be returned many times. If hospitals are serious about limiting their risk, they must insist to all medical staff that their continuing appointment depends on maintaining an adequate standard of medical record. Doctors, in their own interest, should support such a move. A medical record review should be conducted every six months in all hospitals. A preliminary analysis of the results of a survey by the Australian Council on Healthcare Standards confirms that a significant proportion of hospital medical records are inadequate (Dr Denis Smith, Australian Council on Healthcare Standards, personal communication). Integration, organisation and problem resolution While doctors and other hospital staff must play an important part in risk management activities, it is hospital management that must make policy decisions and allocate sufficient resources to ensure implementation. Implementing and conducting these activities requires planning, organisation and management. Effective credentialling of medical staff alone is a complex undertaking requiring management resources. Furthermore, it is little use conducting incident monitoring, complaints monitoring or infection control if there is no organisational arrangement in the hospital with the authority and the capacity to correct problems that these initiatives reveal. The absence of problem-resolution mechanisms in hospitals is a major cause of poor quality and unnecessary risk. Conclusion Both hospital managements and MDOs have a role to play in containing the rising cost of professional indemnity. More effective efforts by hospitals to manage the risk of claims against them and their medical staff is the first essential. Effective credentialling of medical staff and a serious effort to improve medical records alone would result in a significant reduction in claims and hence in premiums. Doctors alone do not have the authority to implement effective risk management in hospitals, but they can certainly bring their considerable influence to bear on hospitals to implement the range of activities we have described. Doctors should also be reassuring their hospitals that risk management initiatives have their full collective support. Better claims management is the other essential requirement and this lies in the hands of the MDOs. These organisations have to continue the process of internal reform that they have already started or they will have reform forced upon them by commercial competition. Without these changes, the current escalation of indemnity premiums for doctors is unlikely to be effectively addressed. References Wilson LL, Goldschmidt PG. Quality management in healthcare. Sydney: McGraw-Hill; 1995. Quality and Outcomes Branch, Commonwealth Department of Health and Aged Care. Clinical Risk Management in Rural Victoria. Better Health Outcomes (A newsletter for the Health Service). 1998; December: 16. Bennett B. Quality care through risk management. Orthopaedic Nursing 1993; 12(3): 54-55. Atkins P. Reducing risks through quality improvement, infection control and risk management. Crit Care Nurs Clin North Am 1995; 7: 733-741. Murphy D. The development of a risk management program in response to the spread of bloodborne pathogen illnesses. J Intravenous Nurs 1995; 18 Suppl 6: S43-S47. Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized patients: results of the Harvard Medical Practice Study I. N Engl J Med 1991; 324: 370-376. Leape LL, Brennan TA, Laird N, et al. The nature of adverse events in hospitalised patients: results of the Harvard Medical Practice Study II. N Engl J Med 1991; 324: 377-384. Localio AR, Lawthers AG, Brennan TA, et al. Relation between malpractice claims and adverse events due to negligence. Special article. N Engl J Med 1991; 325: 245-251. Brennan TA. Medical injuries: international perspectives. Med J Aust 1995; 163: 475-476. Black v Lipovac [1998] 699 FCA (4 June 1998). Hirsch D. Lessons from Lipovac Aust Health Law Bull 1998; 6: 85-87. Knowles D. Clinical risk management. Br J Hosp Med 1995; 53: 291-292. Tito F, Chairman. Compensation and Professional Indemnity in Health Care. Review of Professional Indemnity Arrangements for Health Care Professionals. Canberra: Commonwealth Department of Human Services and Health, 1994. Wright T, Eyland A, Cox J. Claiming under the Motor Accidents Scheme. Sydney: Justice Research Centre. August 1998. Wilson LL. Credentialling of hospital medical staff. J Qual Clin Prac Dec 1997; 17: 187-194. Weagly S. Making the case for robust provider credentialling. Health Care Innovations May/June 1996: 29-39. Suarez CA. Training, credentialing, economics and risk management in operative surgery. Int Surg 1994; 79: 268-272. United States General Accounting Office. Health care: initiatives in hospital risk management. Washington: USGAO, 1989: 17. Elnitsky C, Nichols B, Palmer K. Are hospital incidents being reported? J Nurs Admin 1997; 27(11): 40-46. Mant J, Gatherer A. Managing clinical risk. BMJ 1994; 308: 1522-1523. NHS Management Executive. Risk management in the NHS. London: Department of Health, 1993. Authors' Details Health Systems Sciences, School of Public Health, La Trobe University, Melbourne, VIC. Lionel L Wilson, AM, FRACGP, Member of Faculty; Director of Qual-Med Pty Ltd, Sydney. Claims & Liability Management Services Pty Limited, Sydney and London. Max Fulton, LLM, MBA, Director; previously General Manager of United Medical Defence. Reprints will not be available from the authors. Correspondence: Dr L L Wilson, 134 Queens Road, Connells Point, NSW 2221. lwilson10ATCompuserve.com Requirements of the credentialling process Properly constituted credentials committee with terms of reference Carefully prepared minutes Absolute confidentiality Observe the rules of natural justice (ie, a reasonable decision made after giving the affected parties a right to be heard) Highly structured formalised process All medical staff subjected to the same process All decisions in the form of recommendations to the board Procedure-specific decisions to be given in writing to each medical staff member Back to text

Lionel L Wilson · Max Fulton