Volume 170 Issue 1

MJA 1999; 170: 11-14 For editorial comment, see Conyers Abstract - Introduction - Methods - Results - Discussion - Acknowledgements - References - Author's details Abstract Objective: To assess the effect of a total quality management (TQM) approach on the appropriateness of clinical laboratory testing of patients with acute myocardial infarction. Design: Retrospective, control-group, quasi-experimental study. Setting: Two metropolitan teaching hospitals: one involved in the intervention (TQM experimental group); the other had no intervention (control group). Intervention: A multidisciplinary team involved in the development of improvement strategies, including laboratory testing guidelines, education programs, data collection, monitoring and feedback. Outcome measures: Total number of requested clinically indicated and non-clinically indicated tests. Results: The proportion of clinically indicated tests that were requested increased from 77.5% to 88.2% (P < 0.01) and the number of non-clinically indicated tests was reduced by 81.7% with the introduction of the TQM strategies (P < 0.01). Conclusions: The introduction of a TQM approach has improved the appropriateness of test ordering in acute myocardial infarction. The reduction in non-clinically indicated tests could produce substantial savings in hospital pathology costs, and the increase in clinically indicated tests provides better patient care. Introduction The determination of plasma creatine kinase (CK) and creatine kinase-MB fraction (CK-MB) is pivotal in the diagnosis of acute myocardial infarction (AMI).1 However, the inappropriate use of these and other laboratory tests has increased markedly during the past 10-15 years, contributing to escalating healthcare costs2 and undesirable clinical consequences because of false positive results in AMI, often leading to unnecessary further investigations.3A number of reports have indicated an excessive use of laboratory tests in patients admitted to hospital with AMI or other clinical disorders. One Australian study found that at one hospital up to 20% of all laboratory tests were unnecessary.4 Another found that there were three times as many clinical chemistry tests ordered as were appropriate for patients admitted with chest pain.5 Similarly, a recent study found inappropriate testing of calcium, phosphate and magnesium in the emergency department of a United States teaching hospital.6 The conventional approach to address inappropriate laboratory testing has been to target doctors through education,7 feedback8 and providing information on laboratory testing costs.9 Such measures have had limited success, and in most cases have had limited input from clinicians.10 I have examined the effect of a total quality management (TQM) approach (that was developed and introduced by clinicians and other healthcare professionals) on the appropriateness of clinical laboratory test use in the management of patients with AMI. Total quality management refers to the overall approach of managing the total aspects of an organisation's quality. In my study, this involves changing the way quality in test use is viewed, focusing on the customer and including everyone involved in its provision and use in the process of continuous improvement. The specific TQM model I used was the FOCUS-PDCA approach to quality improvement (Box 1).11 Methods Setting and patient groups The study was conducted from March 1993 to August 1995 at two teaching hospitals in Sydney. Patients at Bankstown-Lidcombe Hospital were designated the "experimental" group, and those at Nepean Hospital were the "control" group. Only the experimental group was subjected to the TQM intervention. At the time of the study, Bankstown-Lidcombe Hospital was a 454-bed hospital with 21 724 annual admissions from the Emergency Department and 2355 admissions to the Coronary Care Unit (CCU). Nepean Hospital was a 415-bed hospital with 20 485 annual admissions from the emergency department and 1891 admissions to the CCU. Within the study groups, two subgroups of AMI patients were identified: "suspected AMI" and "confirmed AMI". The suspected AMI group included all patients who were admitted to the CCU via the emergency department with chest pain and electrocardiographic (ECG) signs suggesting AMI: these were greater than 0.1 mV of ST-segment elevation in two or more limb leads or greater than 0.2 mV in two or more contiguous precordial leads, and the Minnesota code was used to classify Q-wave changes.12 Not all the cases of suspected AMI did in fact progress to AMI. Patients were included in the confirmed AMI group if they had a primary discharge diagnosis in accordance with the World Health Organization criteria.13 The diagnosis was confirmed if the patient had at least two of the following three findings: the presence of a typical history of characteristic chest pain, new ECG changes of pathological Q waves, and an elevation of serum CK to 390 U/L or above during the first 72 hours of admission. Improvement process A quasi-experimental design involving a pre-intervention and post-intervention phase with a concurrent control was used to test the effect of the TQM approach. The study was conducted in two 15-month stages. The first stage involved the collection of pre-intervention data. In the second stage the TQM intervention took place. Using the FOCUS-PDCA TQM model, a multidisciplinary team was empowered to make the necessary improvements, which were introduced during the intervention period as they were developed. The team included representatives from all clinical areas involved in the process of laboratory testing. These included the Emergency Department (Director of Emergency, Assistant Director of Nursing, Clinical Nurse Specialist and Senior Medical Officer), CCU (Director of Cardiology, Nurse Unit Manager, Clinical Nurse Specialist), Pathology Department (Director of Pathology, Senior Technologist), and Administration (Deputy Director of Medical Services). The hospital's Quality Assurance Officer was appointed the Quality Advisor for the TQM team. TQM team meetings were held weekly over the first two months of the 15-month intervention period, and then monthly. The TQM team established an overall review and improvement of the total systems and processes involved in test ordering. The team's mission statement was To ensure that the pathology services used are appropriate, effective and efficient for supporting clinical care in AMI. Practice guidelines were introduced for laboratory testing in the management of AMI. Clinicians in the team were actively encouraged to participate in the improvement process. Draft copies of the guidelines were circulated widely to other clinicians for comment. Suggestions for change were considered and incorporated into the guidelines as determined by the team. The guidelines provided details of all recommended laboratory tests during the 72-hour period following the admission of a patient with suspected AMI into hospital. Strategies were developed for education and training programs, feedback mechanisms and ongoing monitoring of performance through data collection and analysis. To implement the changes, the TQM team assigned responsibility to motivated individuals to accomplish specified tasks. Progress reports were provided at subsequent meetings. Medical staff requesting laboratory tests for suspected AMI patients were issued with pre-stamped pathology request forms that listed the recommended tests from the guidelines. Clinically indicated tests Requested laboratory tests were designated as "clinically indicated" if the ordered tests matched those listed in the AMI practice guidelines devised by the team, or if the tests were found to be justified when the patient's records were checked by one of the study's hospital medical officers. Conversely, "non-clinically indicated" tests were all requested tests found to be outside the recommendations of the AMI practice guidelines that could not be justified for inclusion when checked by one of the study's hospital medical officers. Data collection and statistical analysis Once the suspected AMI patients were transferred to the CCU of the experimental group hospital, an audit was undertaken of the laboratory tests requested and the time and date of each blood collection. The data were collected by me in collaboration with the Senior Technologist of the Pathology Department. The findings on the appropriateness of test use were reported to the Emergency Department and CCU staff, and at the team meetings. For each of the confirmed AMI groups, the number of clinically and non-clinically indicated tests were retrospectively determined. Group equivalency between the pre-TQM and post-TQM groups was determined using the t test. Only the results for the confirmed AMI groups are presented here. All data were coded, entered and analysed using SPSS for Windows.14 Ethical approval The study was approved by the Ethics Committees of both the South Western Sydney Area Health Service and the Nepean Health Service. Results The experimental and control groups did not differ in age, sex ratio or length of stay in hospital (Box 2). The proportion of clinically indicated tests that were requested for the experimental group increased from 77.5% before the TQM intervention to 88.2% in the intervention period (Box 3). For the control group, the proportion of clinically indicated tests that were requested did not change significantly (Box 4A). For the experimental group, the number of non-clinically indicated tests per admission was reduced by 81.7% in the intervention period (Box 4B), whereas for the control group this number did not change significantly. Overall, the total number of tests requested at the experimental hospital was approximately halved in the intervention period, whereas there was no change at the control hospital (Box 5). Discussion The introduction of TQM strategies achieved statistically highly significant improvements to the appropriateness of laboratory test ordering in AMI. The findings were sustained over the 15-month intervention period and were not replicated within the concurrently monitored control group hospital. The findings have a number of potentially important economic and patient care implications. Firstly, the 81.7% reduction of unnecessary tests may provide a substantial reduction in the overall cost of hospital inpatient pathology services if the TQM strategies were to be successfully introduced to more clinical situations. Such potential savings remain the challenge for future investigations. Secondly, there was an overall benefit to patient care through the increased use of clinically indicated laboratory tests. In addition, although not reported here, there was a statistically significant improvement to the clinically recommended timing of the blood collections for cardiac enzyme testing. I have not been able to find any study published in medical and health sciences journals during the past 15 years that has used TQM specifically to improve the appropriateness of clinical laboratory use in AMI. However, the FOCUS-PDCA model has had widespread and successful application within the healthcare system.15-16 As the model is process driven, it is likely to be adaptable to other test-ordering processes. My study supports the recent findings by Nardella et al of significant cost reductions and increased appropriateness of testing through the use of continuous quality improvement strategies.17 Although Nardella et al did not specifically use the FOCUS-PDCA model, they adopted a similar improvement approach. Methodologically, however, my study provided several strengths, with the inclusion of a pre-test and a concurrent control group to enable substantial control over threats to internal and external validity. The introduction of the TQM intervention was accompanied by additional staff time spent undertaking activities such as training, meetings, data collection and analysis. There was also medical, nursing and clerical staff time saved as a result of the accompanying improvements to the clerical systems used in test ordering. Although such costs and benefits were not quantified, I suspect that any savings made in staffing time were expended in establishing and maintaining the intervention. Following the 15-month intervention and the disbandment of the formal TQM team, the AMI laboratory testing guidelines remain in operation. However, recent discussions with key personnel from the original team reveal that the pre-stamped pathology request forms are no longer in use and that compliance with the testing guidelines has generally declined. These observations are consistent with those of other studies where improvements have failed to be sustained once improvement strategies had been completed.18-19 In view of the important economic and patient care implications, further investigations should be undertaken on the effects of the TQM approach in a variety of other clinical laboratory testing situations. Acknowledgements This research formed part of a major doctoral study undertaken by the author under the supervision of Professor Graeme Rawson, former Dean of the Faculty of Health, University of Western Sydney, Macarthur, NSW. Thanks also to Ms Margaret Gehrig, Quality Advisor to the study. I also acknowledge the contribution of the staff of the Bankstown-Lidcombe Hospital, particularly the Emergency Departments, Coronary Care Units, Pathology and Clinical Information Departments. Similarly, thanks also to the Clinical Information Department of the Nepean Hospital. References Hamm CW. New serum markers for acute myocardial infarction. N Engl J Med 1994; 331: 607-608. Deeble J, Lewis-Hughes P. Directions for pathology. Background Paper No. 6. Melbourne: National Health Strategy, 1991; 7. Gama R, Swain DG, Nightingale PG, et al. The effective use of cardiac enzymes and electrocardiograms in the diagnosis of acute myocardial infarction in the elderly. Postgrad Med J 1990; 66: 375-377. Grantham P, Weinstein S. Reducing pathology test misuse. Aust Health Rev 1993; 16: 16-23. Ratnaike D, Hunt D, Eilermann R, et al. The investigation of chest pain: audit and intervention. Med J Aust 1993; 159: 666-671. Rose WD, Martin JE, Abraham FM, et al. Calcium, magnesium and phosphorus: emergency department testing yield. Acad Emerg Med 1997; 4: 559-563. Hindmarsh JT, Lyon AW. Strategies to promote rational clinical chemistry test utilization. Clin Biochem 1996; 29: 291-299. Mugford M, Banfield P, O'Hanlon M. Effects of feedback of information on clinical practice: a review. BMJ 1991; 303: 398-402. Winkens RA, Ament AJ, Pop P, et al. Routine individual feedback on requests for diagnostic tests: an economic evaluation. Med Decis Making 1996; 16: 309-314. Goldman L. Changing physicians' behavior -- the pot and the kettle. N Engl J Med 1990; 322: 1524-1525. Hospital Corporation of America. Hospitalwide quality improvement process, strategy for improvement: FOCUS-PDCA. Nashville: Hospital Corporation of America, 1989. Rose GA, Blackburn H. In: Cardiovascular survey methods. WHO Monograph Series No. 56. Geneva: World Health Organization, 1968; 137-153. World Health Organization criteria for the diagnosis of acute myocardial infarction. Geneva: World Health Organization Cardiovascular Disease Unit, 1981. SPSS Inc. SPSS for Windows [computer program]. Version 6.0. Chicago Ill: SPSS Inc, 1992. Rhew E. Quality improvement project reviews: a tool to accelerate the transformation. Jt Comm J Qual Improv 1994; 20: 79-89. Schneider PD. FOCUS-PDCA ensures continuous quality improvement in the outpatient setting. Oncol Nurs Forum 1997; 24: 966-969. Nardella A, Farrell M, Pechet L, et al. Continuous improvement, quality control, and cost containment in clinical laboratory testing. Arch Pathol Lab Med 1994; 118: 965-968. Reeves CA, Bednar DA. What prevents TQM implementation in health care organisation? Qual Prog 1993; 26: 41-44. Chan YCL, Ho SJK. Continuous quality improvement -- a survey of American and Canadian healthcare executives. Hosp Health Serv Adm 1997; 42: 525-544. (Received 24 Oct 1997, accepted 3 Aug 1998) Author's details Division of Public Health, University of Western Sydney, Macarthur, NSW. Godfrey Isouard, BSc, PhD, Lecturer. Reprints will not be available from the author. Correspondence: Dr G Isouard, Division of Public Health, University of Western Sydney, Macarthur, PO Box 555, Campbelltown, NSW 2560. E-mail: g.isouardATuws.edu.au 1: The FOCUS-PDCA model Find a process to improve Organise a total quality management team select team members team building Clarify laboratory test-requesting process flow charts of test-requesting process identify problems customer requirements Uncover causes of poor quality test use causes of variation collect data Select process improvement determine proposed improvements prioritise Plan process improvement develop improvement strategies education and training development Do the improvement pilot test implement strategies collect and analyse data Check results check lessons learnt determine how effort could be improved Act to hold the gain standardise procedures establish monitoring and feedback processes plan continuous improvement 2: Comparison of characteristics of patients with confirmed acute myocardial infarction, before and during the total quality management intervention Experimental group Control group Pre-TQM intervention periodn=252n=203 Mean age in years (95% CI)60.3 (48.6-74.4)59.2 (47.5-71.8) Men:women (%)71.8:28.277.1:22.9 Median LOS in days (95% CI)8.8 (7.2-12.6)8.0 (6.8-11.4) TQM intervention periodn=253n=211 Mean age in years (95% CI)61.0 (49.1-77.3)59.6 (47.8-72.6) Men:women (%)74.7:25.370.8:29.2 Median LOS in days (95% CI)8.0 (6.3-11.4)7.3 (5.4-10.5) TQM=total quality management. CI=confidence interval. LOS=length of stay in hospital. 3: Changes in the use of clinically indicated tests for the experimental confirmed acute myocardial infarction group Pre-TQM intervention period TQM intervention periodPercentage point increase Number of testsNumber of testsin indicated tests Requested*Indicated†Ratio A‡Requested*Indicated†Ratio B§requested (B-A)P Sodium, potassium, chloride2193339464.6%2631318082.7%18.1<0.01 Urea00--00------ Creatinine17532953.2%28129495.6%42.4<0.01 Glucose31052958.6%37552271.8%13.2<0.01 Calcium, magnesium, phosphate758192.6%242885.7%-6.9<0.01 Cardiac enzyme profile§§1860201692.3%1962202496.9%4.70.18 Liver function tests#14715495.5%778491.7%-3.8<0.01 Cholesterol/triglyceride47950495.0%43850686.6%-8.5<0.01 Free thryoxine, thyrotropin304271.4%202676.9%5.5<0.01 Miscellaneous clinical chemical tests116116100.0%8686100.0%0-- All clinical chemical tests5385716575.2%5894675087.3%12.2<0.01 Automated blood count**1136130487.1%1028114889.6%2.40.20 Prothrombin index252252100.0%253253100.0%0-- Miscellaneous haematology tests2424100.0%4545100.0%0-- All haematology tests1412158089.4%1326144691.7%2.30.15 Urine microexamination1111100.0%1414100.0%0-- Miscellaneous microbiology tests1616100.0%2828100.0%0-- All microbiology tests2727100.0%4242100.0%0-- All tests6800877277.5%7262823888.2%10.6<0.01 TQM=total quality management. *Clinically indicated tests that were requested. †Total number of tests that were clinically indicated but not necessarily requested. ‡Pre-TQM tests requested/pre-TQM tests indicated. §TQM tests requested/TQM tests indicated. §§Creatine kinase and creatine kinase-MB. #Total bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyltransferase, alkaline phosphatase, protein, albumin. **Haemoglobin, white cell count, red cell count, platelets. 4: Comparison of the changes in the use of clinically indicated tests (A) and non-clinically indicated tests (B) for the experimental and control confirmed AMI groups APre-TQM intervention period TQM intervention periodPercentage point increase Number of testsNumber of testsin indicated tests Requested*Indicated†Ratio A‡Requested*Indicated†Ratio B§requested (B-A)P Experimental group6800877277.5%7262823888.2%10.6<0.01 Control group7340893382.2%7399920080.4%-1.80.19 BPre-TQM intervention period TQM intervention periodReduction in Total number of tests requestedNumber of tests per admissionTotal number of tests requestedNumber of tests per admissionnon-clinically indicated tests per admissionP Experimental group966738.417767.081.7%<0.01 Control group489024.1484823.04.6%0.48 AMI=acute myocardial infarction. TQM=total quality management. *Clinically indicated tests that were requested. †Total number of tests that were clinically indicated but not necessarily requested. ‡Pre-TQM tests requested/pre-TQM tests indicated. §TQM tests requested/TQM tests indicated. 5: Total number of tests requested in the experimental and control confirmed acute myocardial infarction groups Pre-TQM intervention period TQM intervention period TotalIndicated*Not indicated†TotalIndicated*Not indicated† Experimental group1646768009667903872621776 Control group12230734048901224773994848 TQM=total quality management. *Number of clinically indicated tests requested. †Number of non-clinically indicated tests requested.

Godfrey Isouard

Multicentre studies are now required to go through multiple systems of ethical approval, which adds to costs and delays MJA 1999; 170: 26-28 For editorial comment, see Loblay and Chalmers Introduction - Case study - Discussion - Conclusion - Acknowledgements - References - Authors' details - - More articles on Ethics Introduction This article uses a case study to show that the system of institutional ethics committees (IECs) that has been created in Australia now stands to impede the identification of suboptimal practice and waste in the healthcare system, and that there is a grave danger that IECs will delay or even prevent identification of avoidable threats to health originating either inside or outside the medical system. It presents the case for simplifying the requirements for ethical review of multicentre investigations that require only access to medical records. Case study -- review of prostate cancer management The incidence of cancer of the prostate rose steeply in Australia in the first half of the 1990s, due partly to widespread use of the prostate-specific antigen test for case-finding.1 The rapid increase in incidence, with little concomitant change in mortality,1 had major consequences for the many more men who had to live with the diagnosis and for the health services that had to be provided to them. Recognising this, a multidisciplinary group of investigators is documenting the presentation, investigation and primary management of all cases of prostate cancer diagnosed in Western Australia (WA) in 1992, the year before active case-finding began. Records from the State Cancer Registry, to which notification of cases is mandatory, indicate that 634 new diagnoses of prostate cancer were made in 1992. Linkage to official mortality statistics for WA, for which permission was granted by the Confidentiality of Health Information Committee of the Health Department of Western Australia, revealed that 265 of these men had died by the time that a retrospective review of medical records began in early 1997. The protocol for the study was approved by both the Confidentiality of Health Information Committee and the Committee for Human Rights of the University of Western Australia, the latter being an IEC operating within the terms of the NHMRC statement on human experimentation2 and supplementary note 1 to that statement.3 All but one of the 16 urologists in WA also gave permission for a research nurse to review relevant medical records, to abstract details of each case and to copy pertinent laboratory reports. Information has now been collected for nearly all relevant cases, but only after the investigators had sought and gained ethical clearance from a further 29 IECs or their representatives. Each IEC was sent an initial letter of application, including a copy of the approved research proposal outlining the background, aims and objectives of and methods to be employed in the project, together with copies of the approval from the Committee for Human Rights and the Confidentiality of Health Information Committee. For two IECs, misplaced correspondence necessitated resubmission of the application. In most instances (62%), the hospital IEC approved the project once it had been provided with evidence that another Committee had reviewed and passed the protocol, but this process still took several weeks. Six IECs required multiple copies of an application in a form unique to their institution before the application would even be considered. Four IECs initially took the view, despite the investigators having permission from the creators of the records to inspect them, that the written consent of each patient would be required before his record could be inspected. One committee has remained firm in this view, even when, in supplementary correspondence and in face-to-face discussion, it has been pointed out that this provision might introduce substantial selection bias into the project, that it was not clear who might legitimately give permission on behalf of a deceased patient, and that to ask the investigators to identify and trace next-of-kin was not only an unduly onerous request that would make the study logistically impracticable, but could also result in undue anxiety to the bereaved. The Table shows that it took between two and 11 weeks to obtain rulings on applications to IECs in public hospitals, with the median time from application to receipt of a written response being 6.5 weeks and 75% responding within 8.6 weeks. In the private sector, the median time was five weeks, with 75% responding within 11 weeks. Although one private hospital responded within a week, correspondence with another continued for more than a year after the initial application was submitted before it finally approved access to records with all identifying information removed. This defeats the purpose of the study, as such an arrangement makes it impossible to relate treatment given to outcome of treatment for a particular patient. In the event, at least a tenth of the resources committed to the investigation have been used in preparing applications to and dealing with correspondence from IECs. Discussion This case study highlights many of the issues mentioned in a recent review of the system of IECs in Australia, chaired by Professor Don Chalmers:4 the number of IECs has grown very rapidly in recent years; there is a lack of uniformity in application processes and decisions of different committees; and Australia's present system of ethical overview does not cater well for multicentre investigations. Similar problems have been reported overseas,5 as have long delays and high costs in gaining ethical approval for multicentre studies.6The report from the Review Committee identifies two guiding principles for our system of IECs, namely that the prime responsibility of an IEC is to protect the interests of the subject of the research, and that the responsibility for ethical conduct of the research is vested in the investigator and ultimately in the institution to which he or she is affiliated.4 It does not consider whether an IEC also has a duty in relation to the collective interests of the community that stands to benefit from the results of research. Distinguishing between retrospective and prospective studies The primacy of the interests of an individual participant in a research project seems simple enough, especially when human experimentation is proposed, but, when what is under consideration is only a systematic review of records, how should an IEC balance the likely desire of individuals for confidentiality and privacy against their likely desire for confidence that the system of healthcare they are using, and for which they are paying, is running effectively, efficiently and safely? In our experience, patients see follow-up surveys of their long-term outcome after an admission to hospital as important and they support them strongly. Response rates of 80% or more are readily achieved in such studies, and many participants add complimentary remarks to postal questionnaires to the effect that they perceive such activities as evidence of a commitment to maintaining excellence in the healthcare system. Positive comments are many times more frequent than negative ones. Retrospective reviews of medical records are even less intrusive than postal surveys and are a cheap, relatively rapid and efficient way of gaining a comprehensive view of the health system's response to a particular medical problem. Clearly, they involve use of medical notes for other than the primary purpose for which they were created, but, equally clearly, systematic reviews of this kind are qualitatively different from other research in which participants are asked to undergo additional or novel tests or treatments. For example, in an appropriately designed Phase III trial of a new treatment, there is at least an 80% chance that patients receiving one of the two treatments will have a significantly worse outcome than those randomised to receive the other. It is therefore entirely proper that such studies are subjected to rigorous ethical scrutiny, although, as a recent commentator points out,7 the requirement that the IEC of every hospital participating in a multicentre trial review the same protocol seems needlessly wasteful of time and energy. Contrast such a prospective trial with an investigation of the same drug after it has been on the market for some time when the possibility of a rare teratogenic effect is raised. Under the present Australian system of ethical oversight, investigators collecting data to confirm or refute this association would have to submit a detailed application to the IEC of every health institution with which the mothers of affected and unaffected control children had had contact within the year before the child's birth. The example of Debendox shows that, faced with the threat of litigation and unable to wait for independent investigators to complete a cumbersome and time-consuming series of applications to IECs before even beginning their research, the manufacturer of what may be a safe and useful drug may feel that there is no option but to withdraw the product from the market. In Australia one peer-reviewed case-control study of a possible life-threatening side effect of a drug used in the treatment of asthma was rejected by one IEC, and the investigators estimate that it cost them $20 000 and a year's work to gain approval from 14 other IECs.8 Thus, significant amounts of public money from government agencies or charitable organisations are wasted by IECs requiring that generally innocuous retrospective studies go through multiple ethical reviews. Investigators conducting retrospective studies of all types -- be they of alleged side effects of pharmaceutical agents, the long-term consequences of occupational exposures or military service, or simply descriptions of how particular presenting complaints were investigated and treated by the medical system at a given time -- are acutely aware of the privilege of using existing medical records for their work as well as of the need to observe the highest ethical and scientific standards in their enquiry. Such studies are motivated as much by the public interest as by scientific curiosity, but it is obviously also in the investigators' own interests to ensure that the privileges extended to them are respected and not abused. As supplementary note 6 of the NHMRC statement on human experimentation9 makes clear, in considering applications for approval of research of this kind IECs need to find a balance between protecting the interests of individual patients and not jeopardising the validity and hence broader utility of the results of the research. Need for clear ethical guidelines on retrospective research The focus of IECs is on safeguarding the interests of subjects associated with single institutions and of the single institutions themselves. Supplementary note 1 of the NHMRC statement on human experimentation3 includes no requirement that the membership of an IEC include someone with training or experience in a population-based discipline, and many IECs appear to struggle with the need for a whole-of-population study to include every single case of interest from a defined community, regardless of where that case was diagnosed or treated. Sometimes this is motivated by a reluctance to make "our data" available to outsiders, but more often it seems related to a failure to grasp issues surrounding selection bias and statistical power in studying infrequent but important events. In retrospective research, any harm that might have been done has already occurred, and the challenge is to strike a balance between the risks to privacy and confidentiality associated with a review of existing records and the potential benefits to existing patients, future patients and the public in general.10 If we are not to have regional or whole-of-State ethics committees, IECs should distinguish between retrospective studies based entirely on records, retrospective studies involving contact with patients or their families (and thus collection of new information) and prospective studies, and develop mechanisms for expeditious consideration of at least the first of these. For multicentre studies requiring only access to records, the combination of an established research investigator, clearance from one IEC constituted according to guidelines set down by the NHMRC and permission from the relevant professional specialist body might be the minimum required for approval-in-principle by Chairs of other IECs. Conclusion Currently, the healthcare system has embarked upon a quest for effectiveness and efficiency embodied by the "Golden Fleece" of evidence-based medicine. Measuring our progress towards that goal requires systematic review of past and present practice, which entails applying medical records to a purpose other than that for which they were primarily, but not exclusively, created. This immediately raises complex ethical questions, answers to which are rarely absolute. Yet, IECs should not tie down such studies with red tape, nor needlessly impede the interests of past and future patients and of the broader community. Acknowledgements The study of prostate cancer mentioned in this report is supported by the Health Department of Western Australia and the Cancer Foundation of Western Australia. Professor D'Arcy Holman kindly provided comments on an early draft of the manuscript. References Threlfall T, Whitford M, Thompson J. Cancer incidence and mortality in Western Australia 1992-94. Perth: Health Department of Western Australia, 1996. National Health and Medical Research Council. Statement on human experimentation. Canberra: NHMRC, 1992. National Health and Medical Research Council. Statement on human experimentation: supplementary note 1 -- institutional ethics committees. Canberra: NHMRC, 1992. Review Committee (Chair: Professor D Chalmers). Report of the review of the role and functioning of institutional ethics committees. Canberra: Australian Government Publishing Service, 1996. White AE. Research ethics committees at work: the experience of one multi-location study. J Med Ethics 1996; 22: 352-355. Ahmed AH, Nicholson KG. Delays and diversity in the practice of local research ethics committees. J Med Ethics 1996; 22: 263-266. Beran RG. Should there be an accredited ethics committee system for centralised review of multicentre clinical research? Med J Aust 1998; 168: 174-176. Smith MA, Jalaludin B, Leeder SR, Smith WT. Isn't one institutional ethics committee's approval enough? Med J Aust 1994; 160: 662. National Health and Medical Research Council. Statement on human experimentation: supplementary note 6 -- epidemiological research. Canberra: NHMRC, 1992. Emson HE. Minimal breaches of confidentiality in health care research: a Canadian perspective. J Med Ethics 1994; 20: 165-168. Authors' details Konrad Jamrozik, MB BS, DPhil, FAFPHM, Associate Professor in Public Health. Marlene Kolybaba, BSc, MPH, Research Officer. Reprints will not be available from the authors. Correspondence: Associate Professor Konrad Jamrozik, Department of Public Health, University of Western Australia, Nedlands, WA 6907. Email: konradATdph.uwa.edu.au Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/> © 1998 Medical Journal of Australia.

Konrad Jamrozik · Marlene Kolybaba

Viewpoint Rethinking the early childcare agenda Who should be caring for very young children? Peter S Cook MJA 1999; 170: 29-31 Introduction - High-quality childcare - Evidence of undesirable outcomes - Being with mother - Many mothers want to care for their own children - A rethink is needed - Acknowledgement - References - Authors' details - - More articles on Paediatrics Introduction In Western societies, mothers often seek paid employment because of societal or economic pressures or a desire to continue a career, and place their infants in childcare centres. There is a perception that trained carers can rear children as well as, or perhaps better than, the mothers themselves.1 The Australian Child Care Task Force2 has recommended subsidised expansion of the "childcare industry", saying that all families should have access to affordable, high quality childcare by trained, professional carers. "Childcare" in this article refers to institutional day centre care, but in research studies it may variously mean any regular non-maternal care or non-parental care. Theoretically, children can spend as many hours in childcare by the age of five as they will spend in school over the next 12 years.3 I argue here that for children up to 2½ to 3 years of age, and particularly during infancy, this agenda of subsidised, universally available, high quality professional childcare is misconceived, and a rethink is needed. Evidence suggests that this agenda: Is unrealistic (eg, high quality childcare for all is not affordable); Overlooks accumulating evidence of risks of undesirable outcomes sometimes associated with early childcare; Is contrary to much expert opinion about what is likely to be best for infants; Is contrary to the desire of many working mothers to care for their own children, if they could afford it; and Relies partly on the now-discredited ideology of cultural determinism. High-quality childcare for all is unrealisable Morgan concluded that "Affordable care is low-quality care" and the "difficulties and cost of providing good quality care, with its highly involved and trained staff, small group size, caregiver stability and low infant to caregiver ratios, should surely demonstrate how 'affordable, universally available, good-quality, easily accessible childcare' . . . is a chimaera, unrealisable in the real world."1Australian standards require one carer for five infants under two, which professionals consider inadequate.1,4,5 Moreover, although Australian governments subsidise 60% of childcare costs,2 Loane found "mediocrity more prevalent than excellence",4 reporting that an assessment of half of Australia's 2400 childcare centres showed 13% failed the national accreditation3 and 40% achieved only the minimal standard, with frequent inadequacies in areas such as child management, safety, health, and nutrition.4 Evidence of undesirable outcomes, sometimes independent of quality Evidence about the effects of childcare, beneficial or harmful, is incomplete and sometimes contradictory. Research into outcomes (whether by standardised tests, or behavioural or socioemotional ratings) is inherently complex, with imperfect instruments, and many confounding variables. Longitudinal studies, showing longer term outcomes, require dedication, expertise, time and money. The interpretation of outcome studies has been hotly debated.6-9 While many infants in childcare apparently thrive, Morgan has reviewed the "mounting evidence of adverse side-effects",1 and some of the evidence pointing to risks is outlined here. Not surprisingly, children in childcare have an increased risk of infectious diseases,10 but the psychological effects are of most concern, as the foundations of the human mind and emotional development are laid in these early years.11 An enduring aspect of the child's world is the parent-child relationship, and one central feature of this relationship is the infant-mother attachment. As mammals, secure attachments between infants and their mothers (and/or effective surrogate mothers) have been vital for our species' survival.7,8,12 Research shows that the security or insecurity of this attachment provides the foundation upon which subsequent relations with adults and peers are built.12 According to Rutter, moderate but significant associations have been found between insecure attachment and various forms of psychopathology both in childhood and adult life.13 To settle some controversies, a multicentre, longitudinal US childcare study is currently investigating the influence and interactions of selected variables on childcare outcomes. These variables include child's sex and temperament, mother's psychological adjustment and sensitivity in the home and at play, and type of childcare, age of child at entry, amount and stability of childcare, and childcare quality assessed for the individual child. This study has established that the security of infant-to-mother attachment can be reliably and validly assessed at 15 months of age.14 Some findings associated with increased risk are shown in the Box. While some of these differences were modest or small, they were consistent in direction. Further analysis through the course of this major study may illuminate the longer-term significance of these findings. Meanwhile, although earlier research had limitations (eg, sample bias and lack of standardised measures of childcare quality), a meta-analysis17 of the 101 childcare outcome studies from many countries published in peer-reviewed journals between 1957 and 1995 found robust evidence of adverse outcomes associated with non-maternal care in the areas of children's infant-mother attachment security, their socioemotional development (including increased anger, anxiety, and hostility in boys, and overdependency, anxiety, and depression in girls), and in their behaviour (including hyperactivity, aggression and non-compliance). They found no support for the belief that high quality day care is an acceptable substitute for parental care. Statistical analysis of group findings can obscure individual reactions. Harsman18 studied 26 infants before they commenced Swedish quality long daycare centre at ages ranging from 6 to 12 months. She followed them through five months in childcare, comparing them with 26 controls (matched pairwise for age, sex and socioeconomic background) cared for by their mothers. Although many infants adjusted easily to childcare, at one stage 11 of the children were assessed as "sad and depressed" in the childcare situation. By the end of the study, the childcare group showed significantly lower scores than the mother-care group in the hearing, speech, and personal-social subscales of the Griffiths' Mental Development Scale.18 Space precludes discussion of the adverse effects on parents, but many mothers in two-income families are overloaded and "stressed-out".1,2 Being with mother is likely to be best This childcare agenda, in disregarding the child's age, is contrary to much expert professional opinion that, ideally, it is likely to be best for very young children to be mostly with their mothers. Of 904 professional members of the World Association for Infant Psychiatry and Allied Disciplines from 56 countries, 402 responded anonymously to a survey asking what kinds of care, at various ages up to 36 months, they considered likely, ideally, to be best from the infants' viewpoint.19 A majority of the respondents believed that it is "very important" for infants "to have their mothers available to them through most of each 24 hours" for more than one year, and to be cared for "principally by mother" until over two years. Only 11% selected full-day group care as the best option for children aged up to 30 months. The author concluded: "The findings show that the polled professionals consider that the development and well-being of children under 3 would be served best by patterns of care that are diametrically opposed to those politicians promise, policy-makers aspire to provide and parents strive to find".19 Many mothers want to care for their own children According to extensive surveys of mothers seeking or using childcare in order to work, many mothers would prefer to care for their young children at home if they could afford to do so.1,20,21 Moreover, in 1993, 65% of Australians reportedly thought it preferable that mothers of preschool children should not take paid employment outside the home.22 Yet when, as in Australia, taxation systems largely disregard childrearing costs23 and favour two-income families, the latter can outbid single-income families in acquiring homes. Prices rise to the level the market will bear and, to compete, more mothers seek paid employment and childcare.1,24 Childcare subsidies aggravate this vicious circle, unless balanced by equal help to home-caring parents through "family-friendly" taxation policies.23,25 A rethink is needed This childcare agenda relies partly on the now-discredited ideology of cultural determinism,26-28 which taught that human nature is culturally determined by social conditioning, denying evolutionary and biological influences. Yet the needs of infants and their mothers, as mothers, are based in our genes and cannot be refashioned to suit ideologies. We need social patterns of support for parenting which respect the human givens, recognising that we each have a pedigree of mothers who, overall (through millions of years), were selected for success in all the essential processes of primate mothering -- including childbirth, breastfeeding, and bonding/attachment, as well as the carrying and rearing of a baby girl who would grow up to do likewise -- not in isolation but within a related social group.8,29,30 Research increasingly illuminates the long-term significance of optimal early maternal nurture for healthy cognitive, emotional and physical development.11,31-35 The precautionary principle -- primum non nocere -- is fundamental in healthcare. Large-scale institutional, long-daycare rearing of babies and very young children by professionals offering no continuing relationship with them is without successful precedent in the history of our species. When the evidence and professional opinion agree that mothers are the best people to care for their young children, it seems neither wise nor cost-effective15 for governments to spend large sums of money subsidising childcare for mothers who would prefer to be helped to care for their infants themselves. Perhaps "How can we provide quality childcare for everybody?2" asks the wrong question. Taking into account the biologically determined needs of young human beings and their mothers, we should be asking "How -- in our detribalised societies -- can we best help and support those parents who wish to do a mutually satisfying job of mothering and fathering their infants and young children without jeopardising their own futures?". Some proposals have been offered,1,8,20,23,30,36 and I suggest that if some of the resources directed towards providing childcare were creatively redirected to supporting high quality parenting we would be more likely to achieve our real goal of enhancing the well-being of mothers, young children, and society. Acknowledgement I am indebted to Professor Jay Belsky, Distinguished Professor of Human Development and Family Studies at Pennsylvania State University, for his generous willingness to communicate with me, but responsibility for the text is mine. References Morgan P. Who needs parents? The effects of childcare and early education on children in Britain and the USA. London: Institute of Economic Affairs, 1996: 1-15, 48-58, 90-98, 114-118. Economic Planning Advisory Commission Child Care Task Force. Future child care provision in Australia. Canberra: AGPS, 1996: xv, xvi, 16, 37. National Childcare Accreditation Council. Putting children first: quality improvement and accreditation system handbook. Sydney: National Childcare Accreditation Council, 1993. Loane S. Who cares? guilt, hope and the child care debate. Melbourne: Reed, 1997: 120-152. Hope D. Spare the non-maternal care and nurture the child. The Australian 1998 4 June. Belsky J. Consequences of child care for children's development: a deconstructionist view. In: Booth A, editor. Child care in the 1990s: trends and consequences. New Jersey: Lawrence Erlbaum, 1992: 83-94. Karen R. Becoming attached: unfolding the mystery of the infant-mother bond and its impact on later life. New York: Warner, 1994. Cook PS. Early child care -- infants and nations at risk. Melbourne: News Weekly Books, 1997: 26-31, 76-89, 154-158, 182-190. Ochiltree G. Effects of child care on young children: forty years of research. Melbourne: Australian Institute of Family Studies, 1994. (Early childhood study paper No. 5.) Ferson MJ. Control of infections in child care. Med J Aust 1994; 161: 615-618. Cockburn F. The minds of our children: sensory input and the development of the human infant brain and mind. The British Association of Perinatal Medicine Founder's Lecture. Proceedings of the XVth Congress of Perinatal Medicine; Sep 1996; Glasgow. London: Parthenon, 1997: 53-60. Belsky J, Cassidy J. Attachment: theory and evidence. In: Rutter M, Hay D, editors. Development through life: a handbook for clinicians. Oxford: Blackwell Scientific Publications, 1994: 373-402. Rutter M. Clinical implications of attachment concepts: retrospect and prospect. J Child Psychol Psychiatry 1995; 36: 549-571. National Institute of Child Health and Human Development. Early Child Care Research Network. The effects of infant child care in infant-mother attachment security: results of the NICHD study of early child care. Child Dev 1997; 68: 860-879. Belsky J. Early childcare, parenting, and the parent-child relationship. Invited testimony delivered to the US Senate Subcommittee on Children and Families, 23 Jan 1998. National Institute of Child Health and Human Development. Early Child Care Research Network. Mother-child interaction and cognitive outcomes associated with early child care: results of the NICHD study up to 36 months. Bethesda, Maryland: NICHD, April 1997. Violato C, Russell C. A meta-analysis of the published research on the effects of non-maternal care on child development. In: Violato C, Genuis M, Paolucci E, editors. The changing family and child development. London: Ashgate. In press. Harsman I. Dagliga separationer och tidig daghemsstart. (Daily separations and early entry into day care). Stockholm: HLS Forlag, 1994 (ISBN 91-7656-334-0). Leach P. Infant care from infants' viewpoint: the views of some professionals. Early Dev Parent 1997; 6: 47-58. Leach P. Children first: what society must do -- and is not doing -- for children today. Harmondsworth, Middlesex: Penguin, 1994: 68-102: 240-265. Vandenheuvel A. Mothers with young children: should they work? Do they want to work? Family Matters 1991; 30: 47-49. (Melbourne: The Australian Institute of Family Studies.) Evans MDR. Norms on women's employment over the life course: Australia 1989-1993. Worldwide Attitudes, International Social Science Survey, Australia, ISSN 1323-9589, Canberra: Research School of Social Sciences, Australian National University, 1995. Sullivan L. Tax injustice: keeping the family cap-in-hand. Sydney: Centre for Independent Studies, 1998. (Issue analysis No. 3.) Ochiltree G, Edgar D. Today's child care, tomorrow's children. Melbourne: Australian Institute of Family Studies, 1995. (Early childhood study paper No. 7.) Casey DJ. Economic justice for the family. The Australian Family 1996; 17(3): 11-17. (Melbourne: The Australian Family Association.) Freeman D. The debate at heart is about evolution. In: Fairburn M, Oliver WH, editors. The certainty of doubt: Tributes to Peter Munz. Wellington: Victoria University Press, 1996. Freeman D. Margaret Mead and the heretic: the making and unmaking of an anthropological myth (Foreword). Melbourne: Penguin, 1996: vi-xiv. Freeman D. The fateful hoaxing of Margaret Mead: an historical analysis of her Samoan researches. Boulder, Colo: Westview, 1998. Werner EE. Infants around the world: cross-cultural studies of psychomotor development from birth to two years. J Cross-Cult Psychol 1972; 3: 111-134. Cook PS. Childrearing, culture and mental health: exploring an ethological-evolutionary perspective in child psychiatry and preventive mental health, with particular reference to two contrasting approaches to early childrearing. Med J Aust 1978; Spec Suppl 2: 3-14. Lucas A, Morley R, Cole TJ, et al. Breast milk and subsequent intelligence quotient in children born pre-term. Lancet 1992; 339: 261-264. Prescott JW. Affectional bonding for the prevention of violent behaviors: neurobiological, psychological, and religious/spiritual determinants. In: Hertzberg AJ, et al, editors. Violent behavior, Vol 1: Assessment and intervention. New York: PMA Publishing, 1990: 110-142. Prescott JW. The origins of human love and violence. J Prenat Perinat Psychol 1996; 10(3): 143-188. Higley JD, Thompson WW, Champouz M, et al. Paternal and maternal genetic and environmental contributions to cerebrospinal fluid monoamine metabolites in Rhesus monkeys (Macaca mulatta). Arch Gen Psychiatry 1993; 50: 615-623. Meaney MJ, Bhatnagan S, Dioria J, et al. Molecular basis for the development of individual differences in the hypothalamic-pituitary-adrenal stress response. Cell Mol Neurobiol 1993; 13: 321-347. Cook PS. Antenatal education for parenthood, as an aspect of preventive psychiatry: some suggestions for programme content and objectives. Med J Aust 1970; 1: 676-681. For comment see Slack-Smith et al's Letter to the Editor 2 August 1999 Authors' details 62 Greycliffe Street, Queenscliff, NSW 2096. Peter S Cook, FRANZCP, MRCPsych, Child Psychiatrist (retired). Reprints: Dr P S Cook, c/o PO Box 84, Repton, NSW 2454. Email: pcookATmidcoast.com.au ©MJA 1999 © 1999 Medical Journal of Australia. Some findings of a major longitudinal childcare study in the United States Analysis of children aged 15 months found:14,15 Quality of care was important, assessed, not globally, but by how sensitive, responsive, affectionate and (cognitively) stimulating the carers were in the individual carer-child relationship. Children in lower quality childcare risked adverse outcomes.15 Evidence for whether quality childcare compensated for lower quality maternal care was mixed, but the less time children of insensitive mothers spent apart from them in childcare the more likely they were to be securely attached. Regardless of childcare quality and other variables, boys in more than 30 hours of non-maternal care per week had an increased risk of insecure attachment. Infants whose mothers rated in the lowest 25% for "sensitivity" (summarising extensive observational assessments) had an increased risk of insecure attachment if they had over 10 hours' non-maternal care per week. Childcare of low quality, or instability (more than one change of arrangement), each independently increased an infant's risk of insecurity. Separate risk factors appeared to be cumulative in their effects. Analysis of children aged 36 months found:16 Family and child characteristics were major influences in predicting outcomes, both in mother-child relationships and in cognitive and language areas. Childcare variables had smaller, but consistent, additional effects on mother-child relationships. Poorer-quality childcare had adverse influences, and more hours in non-maternal care (mean weekly hours recorded across 0-6, 0-15, 0-24, and 0-36 months) were associated with less sensitive and engaged mother-child interactions across the first three years, and with the child showing less affection towards the mother at 24 and 36 months. Back to text

Peter S Cook