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The role of medical associations in quality assurance
Health Policy, 4 (1985) 291-305 Elsevier
291
HPE 00026
The role of medical associations in quality assurance Jan Director, Department
E. Blanpain
of Hospital Administration and Medical Care Organization, Leuven. Belgium (Accepted
for publication
19 December
University of Leuven.
1984)
Summary The European governments have decided to install quality assurance programmes in their health care systems by 1990. Quality is being defined as: “safe, effective, efficient, acceptable and appropriate care rendered by competent providers on the basis of efficacious technology”. A wide range of methodologies is available for the assessment of each or several of the different dimensions of quality. Implementing these methods can be the role of either voluntary organizations or of mandatory ones. Medical associations could assume a leadership role in the field of quality assurance and contribute to the development of data-poor assessment systems and to the strengthening of existing information and management systems. The prevailing concept of clinical autonomy and its use in the practice of medicine should be revised. quality
assurance;
technology
assessment;
medical
associations;
clinical
autonomy
Introduction At its 34th session in Copenhagen in September 1984, the Regional Committee for Europe of the World Health Organization elaborated on its regional strategy for attaining health for all by the year 2000 and refined its proposal, initiated in 1980, for a set of 38 specific regional targets. The Regional Committee feels: “that such targets
should
motivate
Member
goal, by suggesting levels of improvements
States to get actively involved in reaching the health for all required in the health of their populations
achieving them.”
016%8510/85/$03.30
5 1985 Elsevier Science Publishers
B.V. (Biomedical
Division)
as well as ways of
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In line with the proposed pursuit of the targets, indicators and software are being developed to monitor progress towards health for all. This paper specifically discusses targets 31 and 38 of the regional targets strategy which was endorsed by the Regional Committee during the period 24-29 September 1984. Both targets deal with the issue of assessment: Target 31: “By 1990, all Member States should have built effective mechanisms for ensuring quality of patient care within their health care systems. This could be achieved by: establishing methods and procedures for systematically monitoring the quality of care given to patients and making assessment and regulation a permanent component for health professionals’ regular activities; providing all health personnel with training in quality assurance.” a formal Target 38: “Before 1990, all Member States should have established mechanism for the systematic assessment of the appropriate use of health technologies and of their effectiveness, efficiency, safety and acceptability, as well as reflecting national health policy and economic restraints. This could be done if governments adopted a clear policy for systematic and comprehensive assessment of all new technical devices designed for use in the health field, to be carried out in a manner suited to the characteristics of their countries and if an international system for the exchange of information of this subject were set up.” [I] This paper starts from the assumption that assessment of quality of care and of technology are legitimate concerns and that they require dedicated efforts. It is beyond the scope of this paper to review in detail the evidence which supports this assumption. The main reasons which not only warrant but which virtually demand sustained efforts of quality assurance and technology assessment are: * the rapid obsolescence of customary practice in terms of efficacy and safety [2] * the geographic variations in medical practice in “small area” comparison [3] * the elasticity of medical practice under changing financial compensation [4] * the questionable cost-effectiveness of certain technologies or forms of care [5] * the need to allocate scarce resources among competing needs while safeguarding equity and quality [6] * the need to base fundamental health policy choices on better evidence than mortality rates or conventional wisdom [7] * the need for substantiated proof of the exact impact of health care on survival, health status and quality of life [8] * the increase in litigation and its opportunity costs in terms of risk management
PI. Following an introductory discussion of concepts and definitions regarding quality, technology and assessment, this paper in the first place reviews, from an international perspective, the available and emerging assessment methodologies. It then reflects on the different management and information systems which societies currently use or consider in relation to quality assurance and technology assessment. Finally the
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medical profession in general and medical associations in particular are discussed in relation to their role in assessment of care and technology.
What’s in a name?
Quality, technology and assessment are terms which each convey different meanings according to the time period in which they were considered or depending on the party or health care constituency addressing the issue within a given time period. Using definitions across borders of either time periods or health care segments can lead to misunderstanding and confusion. Quality
Medical doctors tend to interpret quality of care in terms of documented compliance with the state of the art, at the time of the assessment, as practiced by outstanding colleagues in the peer group. This state of the art is reflected both in the use of technology and in publications in leading scientific journals. Patients on the contrary, view quality more in terms of immediate outcome and of the interpersonal experiences during the process of care. In particular they focus on elements such as: technical skills; accuracy in the administration of care; empathy on the part of the providers of care; concern for human dignity; the extent and manner in which information about prognosis is conveyed; and finally physical comfort in general. Nurses for their part stress quality aspects within an holistic approach to patient care. They emphasize the interaction of physical and non-physical needs of the patient as a unique individual. The degree to which care interventions strike a balance in meeting those needs determines, in their opinion, the quality of care. Moreover they place particular emphasis on continuity of care and its effectiveness in restoring or maintaining self-reliance. Governments on the other hand, in particular at present, value the degree to which health care meets criteria of equity, safety and cost-effectiveness. However the removal of fraud, abuse and dishonesty are often implicitly included in the quality concept. In a number of cases quality review programmes in fact only seek to identify blatant abuse. Quality is definitely a multi-dimensional concept. Some of the dimensions of quality appeal more than others to given constituencies. Some definitions of quality are all inclusive while others exclude such dimensions as efficiency, accessibility, or outcome of care. A gradual consensus seems to emerge though on the following dimensions of quality: is the composite of (a) knowledge (factual knowledge and * competence: understanding relating to the function which the provider of care performs), (b) abilities (communication skills, technical skills, self-discipline and professional attitudes) and (c) clinical judgment to apply the appropriate knowledge and skills.
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*
*
*
* *
*
efficacy:
is the probability of benefit to individuals in a defined population from a given care intervention or technology applied to a given health problem under “ideal” conditions. is the probability of benefit to individuals in a defined populaeffectiveness: tion from a given care intervention or technology applied to a given health problem under “average” conditions. is the cost in terms of money, human and physical resources, efficiency: and time related to the benefit achieved as compared with the total cost involved in the care intervention. is how recipients of care value the care received in terms of acceptability: satisfaction or dissatisfaction. is a judgement of the acceptability of relative risk in a specified safety: situation. Risk is a measure of the probability of an adverse or untoward outcome occurring and the severity of the resultant harm to health of individuals in a defined population associated with given care or with use of given health technology applied to a given health problem under “specified” conditions of use. appropriateness: is the degree to which care or technology is indicated for a given health problem taking into consideration the related ethical, economic and societal issues. To a certain degree this dimension overlaps such dimensions as effectiveness, safety, efficiency and acceptability. Using the dimensions of care as outlined above, quality care could be defined as: “safe, effective, efficient, acceptable of efficacious technology”.
and appropriate
care rendered
by competent
providers
on the basis
It should be stressed that quality of health care does not always present an homogeneous mix of the different dimensions. While scoring high on one dimension quality does not necessarily rank as high in other dimensions. Similarly, care of a particular quality at one moment will not automatically remain at that level as time passes on. Both aspects have importance for the methodologies of assessment of care and for the interpretation of their findings. Indeed most methods of assessment rarely address all dimensions and do not allow conclusions to be drawn beyond the dimension actually being evaluated.
Technology In a number of milieus the term technology is used in a restricted sense of machine technologies. Health technology is thus understood to be equipment which has been specifically designed for health care interventions such as CT-scanners, artificial kidneys, intensive care monitoring, etc. Distinctions are also being made between “little ticket” technologies and “large ticket” technologies mainly to distinguish technologies which differ in relation to capital investment and (or) operating costs. Lewis Thomas distinguishes three types of technology: (a) “nontechnology” which although sometimes having a supportive role does not affect the natural course of disease or its eventual outcome; (b) “halfway technology” designed to make up for
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disease, or to postpone death; and (c) “decisive technology” which is genuinely effective and which alters the natural course of disease in a beneficial way. Lewis Thomas argues that the gradient of effectiveness presented by the three types of technology is inversely related to a gradient of expenditures: we spend less on decisive technology than on halfway technology or nontechnology [IO]. John Kenneth Galbraith defines technology with reference to the original meaning of the Greek root “technei” as: “the systematic application of scientific or other organized knowledge to practical tasks” [ 111. The Office of Technology Assessment of the United States Congress (OTA) has advocated a similar global definition of health technology which is thus defined as: “The drugs, devices, and medical and surgical procedures used in medical care, and the organizational and supportive
systems within which such care is provided”
[12].
Assessment Assessment of quality and technology assessment have a great deal in common, Technology assessment being of a more recent origin, at first glance gives the impression of belonging to a class on its own. However when operational programmes of technology assessment and quality assurance are being compared, the similarities and duplications are striking. Broadly speaking, technology assessment tends to focus more on efficacy and safety aspects as compared to quality assurance which stresses efficiency and effectiveness. However, both are being discussed together as a cluster of available programmes. Originally, assessment was principally considered to be the comparison of given aspects of care or technology against implicit or explicit criteria resulting in a statement about the care or the technology. In a second phase the cycle of assessment was expanded to include the necessary readjustments and changes in the development of care and the deployment of technology. The term quality “assurance” for instance seeks to emphasize this expansion of the scope of assessment. In the process it became gradually clear that in the past most, if not all, methodological efforts had been concentrated on assessment in the strict sense. There had been a benign neglect of methodologies that would effectively introduce the changes indicated by the evaluation findings. This probably partly explains the rather limited social impact so far of assessment of health care [13].
Assessment methodologies Several taxonomies have been developed for the classification of assessment methodologies for quality assurance or technology. The most frequently cited methodology uses the type of the object of assessment as the criterion for the taxonomy. Three major types: structure, process, and outcome were suggested by Cecil Sheps and developed by Avedis Donabedian [14]. Structure refers to the human and physical resources and their capacity to deliver care. Accreditation is a method of assessment which primarily addresses structure as its object of evaluation.
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Process refers to the activities undertaken in the delivery of care. Medical audit and nursing audit are examples of process oriented assessment. Outcome refers to the results of the care episode. Medical risk management takes negative outcomes as its object of assessment. The structure-process-outcome taxonomy has certain advantages. It enables a number of gradients which are present in ‘the available set of methodologies to be stressed. * The gradient of feasibility decreases from structural assessment to outcome assessment. Inspecting facilities is easier than monitoring activities, which in itself is more feasible than evaluating results of care. * The gradient of validity of criteria and as a consequence the validity of assessment findings increases from structure towards outcome. Criteria used in assessment of structure have proven to be of questionable validity. This is less so for process oriented criteria although they again are less valid, on average, than outcome criteria. This important gradient has led some to advocate the abandonment of methods which rely on non-validated criteria and to favor outcome oriented assessment. * The gradient of potential for timely adjustment of care however diminishes sharply between assessment of structure and process on the one hand and evaluation of outcome on the other. Outcomes of care tend to trail off over lengthy time periods, in particular when chronic illness is involved. Eventually recipients of the care under investigation may prove difficult to trace. Moreover, the fact that outcomes themselves are usually a composite of many influences (lifestyle, natural course of the illness, actions of third parties) compounds the difficulty in determining exactly what the influence of the care intervention has been. * The gradient of threat and the concomitant gradient of resistance increase steeply from structural assessment towards assessment of outcome. The potential for “witch hunt” is always more present, at least in the minds of those being assessed, in methods which rely on assessment of outcome. Understandably, only when special arrangements are made to prevent turning outcome assessment into a “kangaroo court”, and only when these arrangements are scrupulously respected, is evaluation of outcome viable and effective. The “Confidential Inquiries into Maternal Deaths in England and Wales” are a good example of how outcome oriented assessment can have a successful impact when special arrangements are made to defuse the potential threat to practitioners as a group [15]. The taxonomy which uses structure, process and outcome as criteria for classification, although useful in identifyingcharacteristics which are relevant forhealth policy, lacks practicality when it comes to classify a growing number of operational methods. Indeed most of them are oblivious of the taxonomy and cover several of the criteria. For example the Performance Evaluation Programme, at one time introduced by the Joint Commission on Accreditation of Hospitals in thousands of hospitals in the USA, addressed process as well as outcome aspects of hospital based care [ 161. The “Medical Care Programmes” in Scandinavia encompass the full spectrum of structure, process and outcome [ 171. A taxonomy which classifies methodologies according to the dimension(s) of
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quality which they respectively address has the advantage of focussing attention on the particular scope of the assessment. This in turn provides better opportunities for identifying the policy implications of the findings and the necessary adjustments. Assessment of competence Licensing: is usually achieved by offering an examination to individuals who meet minimum educational requirements. There is a growing trend towards requiring periodic relicensing as a method of assuring competence. Self assessment: is a structured and systematic process permitting to identify areas which require correction in certain areas of the competence of the individual professional. Monitoring of progress through repeated self assessment is part ofthe process. The American College of Hospital Administrators for instance has developed computer based self assessment instruments for health services administrators. Patient management problem: PMP is a simulation method developed in 1955 to test the clinical judgement. Computer assisted PMP simulation nowadays provides highly reliable and validated testing of clinical judgement [18]. Assessment of efficacy and safety Preclinical testing: many medical technologies are evaluated in biochemical and animal tests prior to human experimentation. These preclinical tests are increasingly mandatory to give evidence prior to human experimentation and later to prove compliance with standards of marketability. Controlled clinical trial: the CCT is an experimental design by which human or animal subjects are assigned, in accordance with predetermined rules, either to an experimental group or to a control group. The subjects in the experimental group receive a clinical intervention or dosage level of uncertain efficacy or safety. The subjects in the control group receive some other intervention or dosage level, usually the customary or conventional one or a placebo. If the predetermined rules specify that the subjects are assigned to groups randomly, the result is a randomized controlled clinical trial (RCTT). the purpose of the CDC is to evaluate scientConsensus development conference: ific information on an established or emerging technology, to synthesize that information and to provide a consensus statement that advances the understanding of the technology in question and that will be useful to health professionals and the public at large. The National Institutes of Health in Bethesda have pioneered the CDC development which is currently being imported in a number of European countries [19]. of adverse reactions after pharmaceutiPost-marketing surveillance: monitoring cals or other medical products have been released for marketing is increasingly being introduced. studies the determinants and the distribuEpidemiological studies: epidemiology tion of diseases and injuries in human populations. Such studies can be purely descriptive, or analytic or even experimental. Examples abound of how epidemiology can contribute to determine the efficacy and safety of medical interventions and technology [20].
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Assessment of effectiveness and safety Criterion-based peer review: several variants have been developed in which implicit or explicit criteria are used retrospectively to assess the effectiveness and undesirable outcomes of health interventions. Medical audit [21], nursing audit [22], Performance Evaluation Programme (PEP) [16] are examples of peer review. Risk management: focuses on untoward outcomes and other events that are preventable, Medical risk management is restricted to medical care. Risk management can encompass all the risks and related costs that an organization can face not only in relation to its patients but also with respect to its human and physical resources, its environment, its image, the goodwill it can generate, etc. [23]. Monitoring “sentinel events” such as untimely death, unnecessary disability, hospital infections, adverse reactions to drugs and antibiotics, complications of surgery or invasive techniques, and readmissions is a typical method of medical risk management [24]. and follow the course of Tracer studies: select a,limited number of conditions patients with these conditions as they proceed through the health care system under assessment. The findings, to the extent that the tracer conditions have characteristics shared by the majority of problems confronting the system, can be used as surrogate indicators for the overall effectiveness and safety of the system [25]. algorithms. Concurrent monitoring: takes the form of using specific intervention In a number of cases such algorithms have already reached the stage of computer aided diagnosis and therapy. The algorithms either result from an extensive and interactive updating process of structured group judgment among leading practitioners or from CCT based studies on efficacy and safety [26]. Assessment of efficiency Utilization review: seeks to control the costs and to promote the efficient use of the resources required for the provision of health care. At the institutional level hospitals in certain countries conduct utilization reviews on such resource aspects as: bed turnover; use of blood for transfusion purposes; use of redundant laboratory tests; use of disposables; use of generic drugs etc. [27]. Profile analysis: seeks, through determining the variation in practice patterns among providers or recipients of care, to correct outlying behavior in the distribution curve. Assessment of appropriateness Accreditation: can be compared with competence testing to the extent that it seeks to establish the capacity to act and the degree of preparedness of institutions instead of individuals. Accreditation originally relied heavily on structural criteria whereas now process criteria and stated outcome criteria are also being used in certain countries. Cost-effectiveness studies: seek to determine the costs of reaching given effects through given health care interventions for well determined problems. Costs in CES are usually expressed in monetary units while the effectiveness is ordinarily expressed
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in terms such as “lives saved”, “disability avoided” or “quality-adjusted life years saved”. CES are used to compare different types of health care interventions or to compare health interventions with non-health interventions, Cost-benefit studies: seek to compare the costs and the benefits of given interventions by expressing costs and benefits in the same, nearly always monetary, measures. The arbitrariness in determining the money value of life and disabilityplus the effects of arbitrary discount rates used to determine the present value of those costs and benefits that occur in future years, have discredited the importance of this type of analysis. Medical care programmes: have been pioneered in Scandinavia with the aim of developing consensus around national protocols which define the role and prescribe the expected behavior. of every element in a tiered health care structure to address certain health problems. Preference is given to health problems with significant prevalence or incidence rates and for which efficacious diagnoses and (or) treatments already exist. The national protocol attempts to reach an agreement on a division of tasks among the providers involved, in relation to a set of cost-effective and safe procedures and technologies [ 171. Quality circles: have recently, in an analogy to what has happened in industry, been introduced mainly in hospitals in the US. Health providers, on a unit or division basis voluntarily participate in problem definition and problem solving concerning the quality of the service being delivered. Experience. to date shows virtually no involvement of physicians in the quality circle approach [28]. Assessment of acceptability Opinion polls: in a number of countries opinion polls on health care are regularly conducted with a representative sample of the population. The questions asked and the opinions sought always include elements of acceptability. A consistent finding in the published polls is the high degree of the average patient’s satisfaction and trust in his physician [29]. care organizaPatient surveys: are customary in many hospitals and ambulatory tions. They rely either on questionnaires or on interviews at the time of discharge. Although the latter are more expensive they have not proved to be superior in termsof reliability and validity to surveys by questionnaire [30]. Sociometric studies: such studies score health care providers on the basis of ranking either by recipients of care or by peers. The ranking by the latter is on the basis of their preference in referral for hypothetical care which might be needed by their spouse or near relatives.
Information
and management systems
are Different strategies can be considered - and in fact exist - when comparisons made of national information and management systems which exist or are being developed to implement the tasks of quality assurance and technology assessment.
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Voluntary versus mandatory
systems
Voluntary efforts to assure quality in health care have a long tradition. Even in the 14th century the faculty ofthe University of Parishadestablishedacertification system. With Church support it conducted trials of unlicensed practitioners in an attempt to eradicate charlatanism. This included removing women from the healing arts because of their alleged ignorance [31]. Impressive contemporary examples exist of voluntary assessment efforts which were initiated and maintained by such voluntary agencies as provider associations, learned societies, voluntary health insurance funds, pharmaceutical and medical-technical industries, philanthropic foundations, and associations of patients. The CBO Foundation created in The Netherlands in 1979 by the National Specialists’ Association and the Medical Association for the Improvement of Hospital Care, “to stimulate and guide quality monitoring and assurance activities in the Dutch hospitals” epitomizes one of the outstanding recent initiatives amongst European countries. The Joint Commission on Accreditation of Hospitals in the US had its origins in a program for hospital evaluation established by the American College of Surgeons in 1918. In 1951 the JCAH was formed under the joint sponsorship of the American College of Surgeons, the American College of Physicians, the American Medical Association, the American Hospital Association and the Canadian Medical Association. The latter subsequently set up their own hospital accreditation programme in 1959. The JCAH has been used as a model for voluntary efforts in a number of countries. It currently inspires developments in Australia, The Netherlands, and Spain (Catalunya) because it pioneered continent-wide structural evaluation. It also revived interest in updated and validated medical audit programmes as a means of discovering and addressing deficiencies in patient care. The first recorded mandatory quality assurance programme probably goes further back in history than the voluntary ones. In the Louvre Museum in Paris stands a huge block of diorite with the Babylonian King Hammurabi’s code chiselled in cuneiform script. It dates back to 2000 B.C. and in one of the passages of the code physicians are warned against incompetent practice: “. . . if the doctor shall open an abscess with a blunt knife and shall kill the patient or shall destroy the sight of the eye, his hand shall be cut off. . . “. Mandatory programmes have been neither comprehensive nor systematic. In retrospect a certain arbitrariness can be recognized with a preference for given dimensions of quality or for certain technologies [32]. Licensing of health professionals was established in many countries around the turn of the century and has expanded since into proposals for periodic recertification. Safety of drugs has also been an early concern. It led to such programmes as the Food and Drug Administration in the USA which was the model for similar government agencies in various countries. Efficacy as a concern came later in the regulatory approach of pharmaceuticals. Medical products and devices subsequently also became subject to regulatory assessment and quality control. On 28-29 November 1984 the European Economic Community organized its second conference on medical
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products and devices in preparation
for an EEC directive on Good Manufacturing Practices (GMP). Utilization review was first introduced on a nation-wide basis in Germany as a result of the July 31, 1931 agreement between organized medicine and the sickness funds. The agreement provided for regular profiles of physicians’ diagnostic and therapeutic prescriptions. Withholding of payment was used as possible sanctions for extreme outliers in the profiles [33]. This development received so little attention that many American scholars still believe that nation-wide profiling for utilization review purposes originated in the US in the post-World War II era. Many countries have now embarked upon costly utilization review programmes. Such utilization reviews which have themselves been subject to evaluation have consistently been shown to be of dubious cost-effectiveness. Is it necessary to spend hundreds of millions of dollars on full scale utilization reviews with only a 1.269 benefit-cost ratio as demonstrated in the 1979 evaluation of the PSRO programme in the USA? [34]. The controversy surrounding the development of a supersonic civilian aircraft led the US Congress to create an agency to advise it on the environmental, social, economic and ethical implications of technology under development. The Office of Technology Assessment allegedly not only contributed to the demise of the plan to build an American version of the Concorde. Under the impetus of Senator Edward Kennedy it also rapidly attracted attention in health policy circles around the world for its pioneering work in the synthesis of health technology assessment expertise and findings. It is a model for similar agencies under development or consideration in The Netherlands and Scandinavia [35]. Consortium The debate on whether quality assurance and technology assessment should be either predominantly voluntary or mandatory, and the related question regarding the form central agencies should take, has evoked emotion for a number of years. This controversy has consumed a lot of ink without much progress in the direction of either consensus or action. Recently, the discussion has been fuelled by the move towards deregulation which is noticeable in a number of countries. Government agencies traditionally arouse suspicion amongst the professions and industry. These agencies are believed to be responsible for interference in professional prerogatives and are accused of stifling and delaying technological innovation. Moreover the medical profession argues that patient data used for assessment purposes endanger the confidentiality of the doctor-patient relationship anderode the patient’s fundamental right to privacy. The combined opposition of organized medicine and industry in the US led to the demise in 1981 of the National Center of Health Technology which had only been established in 1978 with the major legislative mandate of coordinating all governmental agencies involved in technology assessment. The consortium idea has been advanced recently in a number of countries as a model for a central agency responsible for quality assurance and technology assessment. The Institute of Medicine of the National Academy of Sciences in the USA is
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currently elaborating proposals which were first advanced in 1980 by Relman, the editor-in-chief of the New England Journal of Medicine. The consortium would take the form of a private corporation partly funded by government and health insurers and would, in coalition with provider associations and academia, undertake cost-effectiveness studies with a strong emphasis on the measurement of patient outcome. Similar proposals have been voiced in Britain. An International Association for Health Care Technology Assessment was created in 1984 and has started an International Journal of Technology Assessment in Health Care. Such developments will undoubtedly provide leverage towards solutions in the domain of institutional arrangements for technology assessment.
The role of medical associations Programmes which attempt to improve the quality of care require at least the endorsement, and preferably the active cooperation of professional associations. Physicians as individuals and as a group tend to protect their autonomy and prerogatives. This situation has not always been beneficial for the cause of quality assurance. Although remarkable and somewhat innovative programmes have been initiated or backed by the medical profession, there are still examples of slow response and even delaying tactics which are used to resist the challenge presented by the formidable task of quality assurance. To a great extent this ambivalent situation results from decades of confrontation between organized medicine and government. When Bismarck introduced the first programme of compulsory health insurance in Imperial Germany in 1883 he set the scene for the serious confrontation which erupted many years later around issues of physician’s compensation, patient’s choice and clinical autonomy. The scenario repeated itself in succession in most European countries and was even exported to Japan [32]. In most cases the confrontation led to a stalemate which has sometimes euphemistically been called a “Pax Medica”. Self-regulation, medical autonomy, and free patient choice became the cornerstones of negotiated agreements which were often anchored in specific legislation. These legitimate concerns and principles have, however, occasionally been used to rationalize stonewalling in relation to developments such as quality assurance. Medical associations can and should play a dominant role in the development, diffusion, operation and evaluation of effective, efficient and acceptable assessment methodologies and activities. Data-poor
methods
Computers which at one time were heralded as instruments have paradoxically contributed to a steep increase of complexity society. The availability of “number crunchers” and “gigabyte” aged governments and various bureaucracies to “ask everything to know but were afraid to ask”, particularly from the health
to reduce complexity in many areas of our memories has encourthey always wanted care field.
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Assessment methods should be restricted to minimal data-sets and to statistically valid sampling instead of encompassing the total care universe. Medical associations, by taking affirmative action and a lead in the development and promotion of such data-poor methods, would not only serve their legitimate concern for confidentiality and for efficiency in the assessment process. They would, by the same token, defuse the frequently mentioned inference of their benign neglect towards the systematic efforts for quality assurance. Strengthening
the information
system
Even data-poor assessment methods require reliable data. For a long time it has been recognized that patient care data, be they routine or part of a clinical trial, are of crucial importance as basic prerequisites for any attempt at quality assurance or technology assessment. Medical associations should be the vanguard in the development and implementation of patient care information systems. Strengthening
the management
system
Quality assurance and technology assessment efforts require more than professionalism and ethical standards by each individual member of the medical profession. The algebraic sum of the commitment of individuals who are concerned with quality aspects will not automatically generate the full potential of quality assurance. The high degree of interdependence among the professionals of various disciplines and the competing forces and paradigms of care prevalent in the health system require more than individual commitment. Diffuse medical staff organization coupled with a high level of individual autonomy is still the archetypical mode of institutional involvement of physicians in a number of European countries. The structured group judgment and peer review required by most of the modern approaches to patient information systems in general, and by the corrective management strategies required by assessment findings in particular, are virtually impossible unless there is a high level of medical staff organization with sufficient integration in the overall management of the health care institutions. More effective medical staff organization and involvement into sustained efforts of quality assurance require more than goodwill. It needs managerial know-how and a continuous updating of the knowledge and skills in the increasingly sophisticated state of the art of quality assessment. Medical societies should not only contribute towards the establishment of national entities capable of providing methodological support to budding initiatives at the rank and file level, they should also encourage the infusion of managerial expertise in their ranks. At a time when a surplus of physicians is acknowledged in a number of European countries, causing deep concern among the leadership and the rank and file of the medical profession, physicians should consider a management career and be encouraged to do so. In Europe more than 60 graduate programmes offering training and (or) continuing education in health services management are already in existence. In 1965
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these programmes created a European Association Studies. A number of them have research capacity care assessment.
of Programmes in Health Services and activities devoted to quality of
Clinical autonomy revisited The concept of clinical autonomy and in particular the way it is being interpreted in daily practice is the linchpin of the whole quality assessment exercise. It will determine whether quality assurance is an operational reality or merely an object of lip service. The absolutist viewpoint on medical autonomy is based upon the “prerogatives”of a profession which commands a unique body of knowledge and skills to be applied without any interference from third parties and without any constraints. This viewpoint has become outmoded if it was ever ethically justified. Ethical, medical, and economic considerations have always constituted the dynamic constraints which affect the changing mandate and the concomitant degree of clinical freedom which society is willing to grant its physicians. Medical associations should actively be involved in the “listening post” function to ascertain how society values health, its risks and benefits and the costs of health care interventions. Consideration should be given to the impact that these societal values have on clinical autonomy. A pro-active posture of medical societies in this respect would not mean that they would have to forego their role in critically reviewing changing values in society. It would help to avoid the occasion when professional ethics lags behind society’s values, while providing a better vantage point to contribute constructively to the ongoing social debate. References I 2 3 4 5 6 7 8 9 10 11 12
Regional targets in support of the regional strategy for health for all. WHO-Euro document RC34/7. World Health Organization, Copenhagen 1984. Stone, A.A., The new paradox of psychiatric malpractice, The New England Journal ofMedicine, 31 I (1984) 1384-1387. Schwartz, J.S., The role of professional medical societies in reducing variations, Health Affairs, 3 (1984) 90-101. Anderson, G.F. and Steinberg, E.P., Hospital readmissions in the Medicare population, The New England Journal of Medicine, 311 (1984) 1349-1353. Evered, D. (Ed.), The value of prevention, The Ciba Foundation, Pitman, London, 1985. Willems, J.S. and Banta, H.D., Improving the use of medical technology, Health Affairs, 1 (1982) 86-102. Blanpain, J.E., Het ziekenhuiswezen van morgen: mythen en realiteit, Acta Hospitalia, 25 (1985) 5-18. Fries, J., Aging, natural death, and the compression of morbidity, The New England Journal of Medicine, 303 (1980) 130-135. Gutheil. T.G. et al., Malpractice prevention through the sharing of uncertainty: informed consent and the therapeutic alliance, The New England Journal of Medicine, 311 (1984) 49-51. Thomas, L., The lives of a cell: notes of a biology watcher, The Viking Press, New York, 1974. Galbraith, J.K., The new industrial state, Hamish Hamilton, London, 1967. The implications of cost-effectiveness analysis of medical technology. Office of Technology Assessment, Washington D.C., 1980.
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Hudson, J.I., The changing character Health Care, 1 (1983) 75-84.
14
Sanazaro, P.J., Quality assessment and quality assurance in medical care, Annual Review of Public Health, 1 (1980) 37-68. Report on confidential enquiries into maternal deaths in England and Wales 1958-1960. HMSO, London, 1963.
15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35
of quality
assurance:
activities
in acute care hospitals,
Effective
Jacobs, CM. et al., Measuring the quality of patient care: the rationale for outcome audit, Ballinger Publishing Company, Cambridge, 1976. Poulsen, H. and Thor, T., Medical care programmes, Danish Hospital Institute, Copenhagen, 1980. Taylor, W.R., et al., The use of computerized patient management problems in a certifying examination, The Journal of Medical Education, IO (1976) 179-182. Guidelines for the selection and management of consensus development conferences, National Institutes of Health, Bethesda, MD, 1983. Holland, W.W. and Karhausen, L. (Eds.), Health careandepidemiology. Henry KimptonPublishers, London, 1978. Selbmann, H.K. and Ueberla, K.K., Quality assessment of medical care, Bleicher Verlag, Gerlingen, 1982. Hegyvary, S.T. and Haussmann, R.K.D., Monitoring nursing care quality, The Journal of Nursing Administration, 6/9 (1976) 3-9. Schmitt, J.P., Risk management justification - cost-benefit considerations, The Journal of the Professional Risk Manager (1977) 26-28. Rutstein, D. et al., Measuring the quality of medical care, The New England Journal ofMedicine, 294 (1976) 582-588. Kessner, D.M. and Kalk. C.E., A strategy for evaluating health services, Institute of Medicine, National Academy of Sciences, Washington, DC, 1973. Petit, J.J., The acute abdomen: a computer-aided approach to diagnosis, State University of Groningen, Groningen. 1984. Jennett, B.. High technology medicine: benefits and burdens, The Nuffield Provincial Hospitals Trust, London. 1984. Hospital quality circle programs: a research report, Avatar International Inc., Atlanta, GA, 1983. Blendon, R.J. and Altman, D.E., Public attitudes about health-care costs: a lesson in national schizophrenia, The New England Journal of Medicine, 311 (1984) 613-615. Pascoe, D.W. et al., Patient’s attitudes to health care: a literature review, World Hospitals, 16 (1900) 165-170. Fine, D.J. and Meyer, E.R., Quality assurance in historical perspective, Hospital and Health Services Administration, 28/6 (1983) 94-122. Blanpain, J.E., Technology assessment in Belgium, France, Germany and Japan, Acta Hospitalia, 23 (1983) 37-44. Blanpain, J.E. et al., National health insurance and health resources: the European experience, Harvard University Press, Cambridge. MA, 1978. PSRO 1979 Program Evaluation. Health Care Financing Administration, Washington, DC, 1980. Banta, H.D. and Kemp, K.B.. The management of health care technology in nine countries, Springer Publishing Company, New York, 1982.
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HPE 00026
The role of medical associations in quality assurance Jan Director, Department
E. Blanpain
of Hospital Administration and Medical Care Organization, Leuven. Belgium (Accepted
for publication
19 December
University of Leuven.
1984)
Summary The European governments have decided to install quality assurance programmes in their health care systems by 1990. Quality is being defined as: “safe, effective, efficient, acceptable and appropriate care rendered by competent providers on the basis of efficacious technology”. A wide range of methodologies is available for the assessment of each or several of the different dimensions of quality. Implementing these methods can be the role of either voluntary organizations or of mandatory ones. Medical associations could assume a leadership role in the field of quality assurance and contribute to the development of data-poor assessment systems and to the strengthening of existing information and management systems. The prevailing concept of clinical autonomy and its use in the practice of medicine should be revised. quality
assurance;
technology
assessment;
medical
associations;
clinical
autonomy
Introduction At its 34th session in Copenhagen in September 1984, the Regional Committee for Europe of the World Health Organization elaborated on its regional strategy for attaining health for all by the year 2000 and refined its proposal, initiated in 1980, for a set of 38 specific regional targets. The Regional Committee feels: “that such targets
should
motivate
Member
goal, by suggesting levels of improvements
States to get actively involved in reaching the health for all required in the health of their populations
achieving them.”
016%8510/85/$03.30
5 1985 Elsevier Science Publishers
B.V. (Biomedical
Division)
as well as ways of
292
In line with the proposed pursuit of the targets, indicators and software are being developed to monitor progress towards health for all. This paper specifically discusses targets 31 and 38 of the regional targets strategy which was endorsed by the Regional Committee during the period 24-29 September 1984. Both targets deal with the issue of assessment: Target 31: “By 1990, all Member States should have built effective mechanisms for ensuring quality of patient care within their health care systems. This could be achieved by: establishing methods and procedures for systematically monitoring the quality of care given to patients and making assessment and regulation a permanent component for health professionals’ regular activities; providing all health personnel with training in quality assurance.” a formal Target 38: “Before 1990, all Member States should have established mechanism for the systematic assessment of the appropriate use of health technologies and of their effectiveness, efficiency, safety and acceptability, as well as reflecting national health policy and economic restraints. This could be done if governments adopted a clear policy for systematic and comprehensive assessment of all new technical devices designed for use in the health field, to be carried out in a manner suited to the characteristics of their countries and if an international system for the exchange of information of this subject were set up.” [I] This paper starts from the assumption that assessment of quality of care and of technology are legitimate concerns and that they require dedicated efforts. It is beyond the scope of this paper to review in detail the evidence which supports this assumption. The main reasons which not only warrant but which virtually demand sustained efforts of quality assurance and technology assessment are: * the rapid obsolescence of customary practice in terms of efficacy and safety [2] * the geographic variations in medical practice in “small area” comparison [3] * the elasticity of medical practice under changing financial compensation [4] * the questionable cost-effectiveness of certain technologies or forms of care [5] * the need to allocate scarce resources among competing needs while safeguarding equity and quality [6] * the need to base fundamental health policy choices on better evidence than mortality rates or conventional wisdom [7] * the need for substantiated proof of the exact impact of health care on survival, health status and quality of life [8] * the increase in litigation and its opportunity costs in terms of risk management
PI. Following an introductory discussion of concepts and definitions regarding quality, technology and assessment, this paper in the first place reviews, from an international perspective, the available and emerging assessment methodologies. It then reflects on the different management and information systems which societies currently use or consider in relation to quality assurance and technology assessment. Finally the
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medical profession in general and medical associations in particular are discussed in relation to their role in assessment of care and technology.
What’s in a name?
Quality, technology and assessment are terms which each convey different meanings according to the time period in which they were considered or depending on the party or health care constituency addressing the issue within a given time period. Using definitions across borders of either time periods or health care segments can lead to misunderstanding and confusion. Quality
Medical doctors tend to interpret quality of care in terms of documented compliance with the state of the art, at the time of the assessment, as practiced by outstanding colleagues in the peer group. This state of the art is reflected both in the use of technology and in publications in leading scientific journals. Patients on the contrary, view quality more in terms of immediate outcome and of the interpersonal experiences during the process of care. In particular they focus on elements such as: technical skills; accuracy in the administration of care; empathy on the part of the providers of care; concern for human dignity; the extent and manner in which information about prognosis is conveyed; and finally physical comfort in general. Nurses for their part stress quality aspects within an holistic approach to patient care. They emphasize the interaction of physical and non-physical needs of the patient as a unique individual. The degree to which care interventions strike a balance in meeting those needs determines, in their opinion, the quality of care. Moreover they place particular emphasis on continuity of care and its effectiveness in restoring or maintaining self-reliance. Governments on the other hand, in particular at present, value the degree to which health care meets criteria of equity, safety and cost-effectiveness. However the removal of fraud, abuse and dishonesty are often implicitly included in the quality concept. In a number of cases quality review programmes in fact only seek to identify blatant abuse. Quality is definitely a multi-dimensional concept. Some of the dimensions of quality appeal more than others to given constituencies. Some definitions of quality are all inclusive while others exclude such dimensions as efficiency, accessibility, or outcome of care. A gradual consensus seems to emerge though on the following dimensions of quality: is the composite of (a) knowledge (factual knowledge and * competence: understanding relating to the function which the provider of care performs), (b) abilities (communication skills, technical skills, self-discipline and professional attitudes) and (c) clinical judgment to apply the appropriate knowledge and skills.
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*
*
*
* *
*
efficacy:
is the probability of benefit to individuals in a defined population from a given care intervention or technology applied to a given health problem under “ideal” conditions. is the probability of benefit to individuals in a defined populaeffectiveness: tion from a given care intervention or technology applied to a given health problem under “average” conditions. is the cost in terms of money, human and physical resources, efficiency: and time related to the benefit achieved as compared with the total cost involved in the care intervention. is how recipients of care value the care received in terms of acceptability: satisfaction or dissatisfaction. is a judgement of the acceptability of relative risk in a specified safety: situation. Risk is a measure of the probability of an adverse or untoward outcome occurring and the severity of the resultant harm to health of individuals in a defined population associated with given care or with use of given health technology applied to a given health problem under “specified” conditions of use. appropriateness: is the degree to which care or technology is indicated for a given health problem taking into consideration the related ethical, economic and societal issues. To a certain degree this dimension overlaps such dimensions as effectiveness, safety, efficiency and acceptability. Using the dimensions of care as outlined above, quality care could be defined as: “safe, effective, efficient, acceptable of efficacious technology”.
and appropriate
care rendered
by competent
providers
on the basis
It should be stressed that quality of health care does not always present an homogeneous mix of the different dimensions. While scoring high on one dimension quality does not necessarily rank as high in other dimensions. Similarly, care of a particular quality at one moment will not automatically remain at that level as time passes on. Both aspects have importance for the methodologies of assessment of care and for the interpretation of their findings. Indeed most methods of assessment rarely address all dimensions and do not allow conclusions to be drawn beyond the dimension actually being evaluated.
Technology In a number of milieus the term technology is used in a restricted sense of machine technologies. Health technology is thus understood to be equipment which has been specifically designed for health care interventions such as CT-scanners, artificial kidneys, intensive care monitoring, etc. Distinctions are also being made between “little ticket” technologies and “large ticket” technologies mainly to distinguish technologies which differ in relation to capital investment and (or) operating costs. Lewis Thomas distinguishes three types of technology: (a) “nontechnology” which although sometimes having a supportive role does not affect the natural course of disease or its eventual outcome; (b) “halfway technology” designed to make up for
295
disease, or to postpone death; and (c) “decisive technology” which is genuinely effective and which alters the natural course of disease in a beneficial way. Lewis Thomas argues that the gradient of effectiveness presented by the three types of technology is inversely related to a gradient of expenditures: we spend less on decisive technology than on halfway technology or nontechnology [IO]. John Kenneth Galbraith defines technology with reference to the original meaning of the Greek root “technei” as: “the systematic application of scientific or other organized knowledge to practical tasks” [ 111. The Office of Technology Assessment of the United States Congress (OTA) has advocated a similar global definition of health technology which is thus defined as: “The drugs, devices, and medical and surgical procedures used in medical care, and the organizational and supportive
systems within which such care is provided”
[12].
Assessment Assessment of quality and technology assessment have a great deal in common, Technology assessment being of a more recent origin, at first glance gives the impression of belonging to a class on its own. However when operational programmes of technology assessment and quality assurance are being compared, the similarities and duplications are striking. Broadly speaking, technology assessment tends to focus more on efficacy and safety aspects as compared to quality assurance which stresses efficiency and effectiveness. However, both are being discussed together as a cluster of available programmes. Originally, assessment was principally considered to be the comparison of given aspects of care or technology against implicit or explicit criteria resulting in a statement about the care or the technology. In a second phase the cycle of assessment was expanded to include the necessary readjustments and changes in the development of care and the deployment of technology. The term quality “assurance” for instance seeks to emphasize this expansion of the scope of assessment. In the process it became gradually clear that in the past most, if not all, methodological efforts had been concentrated on assessment in the strict sense. There had been a benign neglect of methodologies that would effectively introduce the changes indicated by the evaluation findings. This probably partly explains the rather limited social impact so far of assessment of health care [13].
Assessment methodologies Several taxonomies have been developed for the classification of assessment methodologies for quality assurance or technology. The most frequently cited methodology uses the type of the object of assessment as the criterion for the taxonomy. Three major types: structure, process, and outcome were suggested by Cecil Sheps and developed by Avedis Donabedian [14]. Structure refers to the human and physical resources and their capacity to deliver care. Accreditation is a method of assessment which primarily addresses structure as its object of evaluation.
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Process refers to the activities undertaken in the delivery of care. Medical audit and nursing audit are examples of process oriented assessment. Outcome refers to the results of the care episode. Medical risk management takes negative outcomes as its object of assessment. The structure-process-outcome taxonomy has certain advantages. It enables a number of gradients which are present in ‘the available set of methodologies to be stressed. * The gradient of feasibility decreases from structural assessment to outcome assessment. Inspecting facilities is easier than monitoring activities, which in itself is more feasible than evaluating results of care. * The gradient of validity of criteria and as a consequence the validity of assessment findings increases from structure towards outcome. Criteria used in assessment of structure have proven to be of questionable validity. This is less so for process oriented criteria although they again are less valid, on average, than outcome criteria. This important gradient has led some to advocate the abandonment of methods which rely on non-validated criteria and to favor outcome oriented assessment. * The gradient of potential for timely adjustment of care however diminishes sharply between assessment of structure and process on the one hand and evaluation of outcome on the other. Outcomes of care tend to trail off over lengthy time periods, in particular when chronic illness is involved. Eventually recipients of the care under investigation may prove difficult to trace. Moreover, the fact that outcomes themselves are usually a composite of many influences (lifestyle, natural course of the illness, actions of third parties) compounds the difficulty in determining exactly what the influence of the care intervention has been. * The gradient of threat and the concomitant gradient of resistance increase steeply from structural assessment towards assessment of outcome. The potential for “witch hunt” is always more present, at least in the minds of those being assessed, in methods which rely on assessment of outcome. Understandably, only when special arrangements are made to prevent turning outcome assessment into a “kangaroo court”, and only when these arrangements are scrupulously respected, is evaluation of outcome viable and effective. The “Confidential Inquiries into Maternal Deaths in England and Wales” are a good example of how outcome oriented assessment can have a successful impact when special arrangements are made to defuse the potential threat to practitioners as a group [15]. The taxonomy which uses structure, process and outcome as criteria for classification, although useful in identifyingcharacteristics which are relevant forhealth policy, lacks practicality when it comes to classify a growing number of operational methods. Indeed most of them are oblivious of the taxonomy and cover several of the criteria. For example the Performance Evaluation Programme, at one time introduced by the Joint Commission on Accreditation of Hospitals in thousands of hospitals in the USA, addressed process as well as outcome aspects of hospital based care [ 161. The “Medical Care Programmes” in Scandinavia encompass the full spectrum of structure, process and outcome [ 171. A taxonomy which classifies methodologies according to the dimension(s) of
297
quality which they respectively address has the advantage of focussing attention on the particular scope of the assessment. This in turn provides better opportunities for identifying the policy implications of the findings and the necessary adjustments. Assessment of competence Licensing: is usually achieved by offering an examination to individuals who meet minimum educational requirements. There is a growing trend towards requiring periodic relicensing as a method of assuring competence. Self assessment: is a structured and systematic process permitting to identify areas which require correction in certain areas of the competence of the individual professional. Monitoring of progress through repeated self assessment is part ofthe process. The American College of Hospital Administrators for instance has developed computer based self assessment instruments for health services administrators. Patient management problem: PMP is a simulation method developed in 1955 to test the clinical judgement. Computer assisted PMP simulation nowadays provides highly reliable and validated testing of clinical judgement [18]. Assessment of efficacy and safety Preclinical testing: many medical technologies are evaluated in biochemical and animal tests prior to human experimentation. These preclinical tests are increasingly mandatory to give evidence prior to human experimentation and later to prove compliance with standards of marketability. Controlled clinical trial: the CCT is an experimental design by which human or animal subjects are assigned, in accordance with predetermined rules, either to an experimental group or to a control group. The subjects in the experimental group receive a clinical intervention or dosage level of uncertain efficacy or safety. The subjects in the control group receive some other intervention or dosage level, usually the customary or conventional one or a placebo. If the predetermined rules specify that the subjects are assigned to groups randomly, the result is a randomized controlled clinical trial (RCTT). the purpose of the CDC is to evaluate scientConsensus development conference: ific information on an established or emerging technology, to synthesize that information and to provide a consensus statement that advances the understanding of the technology in question and that will be useful to health professionals and the public at large. The National Institutes of Health in Bethesda have pioneered the CDC development which is currently being imported in a number of European countries [19]. of adverse reactions after pharmaceutiPost-marketing surveillance: monitoring cals or other medical products have been released for marketing is increasingly being introduced. studies the determinants and the distribuEpidemiological studies: epidemiology tion of diseases and injuries in human populations. Such studies can be purely descriptive, or analytic or even experimental. Examples abound of how epidemiology can contribute to determine the efficacy and safety of medical interventions and technology [20].
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Assessment of effectiveness and safety Criterion-based peer review: several variants have been developed in which implicit or explicit criteria are used retrospectively to assess the effectiveness and undesirable outcomes of health interventions. Medical audit [21], nursing audit [22], Performance Evaluation Programme (PEP) [16] are examples of peer review. Risk management: focuses on untoward outcomes and other events that are preventable, Medical risk management is restricted to medical care. Risk management can encompass all the risks and related costs that an organization can face not only in relation to its patients but also with respect to its human and physical resources, its environment, its image, the goodwill it can generate, etc. [23]. Monitoring “sentinel events” such as untimely death, unnecessary disability, hospital infections, adverse reactions to drugs and antibiotics, complications of surgery or invasive techniques, and readmissions is a typical method of medical risk management [24]. and follow the course of Tracer studies: select a,limited number of conditions patients with these conditions as they proceed through the health care system under assessment. The findings, to the extent that the tracer conditions have characteristics shared by the majority of problems confronting the system, can be used as surrogate indicators for the overall effectiveness and safety of the system [25]. algorithms. Concurrent monitoring: takes the form of using specific intervention In a number of cases such algorithms have already reached the stage of computer aided diagnosis and therapy. The algorithms either result from an extensive and interactive updating process of structured group judgment among leading practitioners or from CCT based studies on efficacy and safety [26]. Assessment of efficiency Utilization review: seeks to control the costs and to promote the efficient use of the resources required for the provision of health care. At the institutional level hospitals in certain countries conduct utilization reviews on such resource aspects as: bed turnover; use of blood for transfusion purposes; use of redundant laboratory tests; use of disposables; use of generic drugs etc. [27]. Profile analysis: seeks, through determining the variation in practice patterns among providers or recipients of care, to correct outlying behavior in the distribution curve. Assessment of appropriateness Accreditation: can be compared with competence testing to the extent that it seeks to establish the capacity to act and the degree of preparedness of institutions instead of individuals. Accreditation originally relied heavily on structural criteria whereas now process criteria and stated outcome criteria are also being used in certain countries. Cost-effectiveness studies: seek to determine the costs of reaching given effects through given health care interventions for well determined problems. Costs in CES are usually expressed in monetary units while the effectiveness is ordinarily expressed
299
in terms such as “lives saved”, “disability avoided” or “quality-adjusted life years saved”. CES are used to compare different types of health care interventions or to compare health interventions with non-health interventions, Cost-benefit studies: seek to compare the costs and the benefits of given interventions by expressing costs and benefits in the same, nearly always monetary, measures. The arbitrariness in determining the money value of life and disabilityplus the effects of arbitrary discount rates used to determine the present value of those costs and benefits that occur in future years, have discredited the importance of this type of analysis. Medical care programmes: have been pioneered in Scandinavia with the aim of developing consensus around national protocols which define the role and prescribe the expected behavior. of every element in a tiered health care structure to address certain health problems. Preference is given to health problems with significant prevalence or incidence rates and for which efficacious diagnoses and (or) treatments already exist. The national protocol attempts to reach an agreement on a division of tasks among the providers involved, in relation to a set of cost-effective and safe procedures and technologies [ 171. Quality circles: have recently, in an analogy to what has happened in industry, been introduced mainly in hospitals in the US. Health providers, on a unit or division basis voluntarily participate in problem definition and problem solving concerning the quality of the service being delivered. Experience. to date shows virtually no involvement of physicians in the quality circle approach [28]. Assessment of acceptability Opinion polls: in a number of countries opinion polls on health care are regularly conducted with a representative sample of the population. The questions asked and the opinions sought always include elements of acceptability. A consistent finding in the published polls is the high degree of the average patient’s satisfaction and trust in his physician [29]. care organizaPatient surveys: are customary in many hospitals and ambulatory tions. They rely either on questionnaires or on interviews at the time of discharge. Although the latter are more expensive they have not proved to be superior in termsof reliability and validity to surveys by questionnaire [30]. Sociometric studies: such studies score health care providers on the basis of ranking either by recipients of care or by peers. The ranking by the latter is on the basis of their preference in referral for hypothetical care which might be needed by their spouse or near relatives.
Information
and management systems
are Different strategies can be considered - and in fact exist - when comparisons made of national information and management systems which exist or are being developed to implement the tasks of quality assurance and technology assessment.
300
Voluntary versus mandatory
systems
Voluntary efforts to assure quality in health care have a long tradition. Even in the 14th century the faculty ofthe University of Parishadestablishedacertification system. With Church support it conducted trials of unlicensed practitioners in an attempt to eradicate charlatanism. This included removing women from the healing arts because of their alleged ignorance [31]. Impressive contemporary examples exist of voluntary assessment efforts which were initiated and maintained by such voluntary agencies as provider associations, learned societies, voluntary health insurance funds, pharmaceutical and medical-technical industries, philanthropic foundations, and associations of patients. The CBO Foundation created in The Netherlands in 1979 by the National Specialists’ Association and the Medical Association for the Improvement of Hospital Care, “to stimulate and guide quality monitoring and assurance activities in the Dutch hospitals” epitomizes one of the outstanding recent initiatives amongst European countries. The Joint Commission on Accreditation of Hospitals in the US had its origins in a program for hospital evaluation established by the American College of Surgeons in 1918. In 1951 the JCAH was formed under the joint sponsorship of the American College of Surgeons, the American College of Physicians, the American Medical Association, the American Hospital Association and the Canadian Medical Association. The latter subsequently set up their own hospital accreditation programme in 1959. The JCAH has been used as a model for voluntary efforts in a number of countries. It currently inspires developments in Australia, The Netherlands, and Spain (Catalunya) because it pioneered continent-wide structural evaluation. It also revived interest in updated and validated medical audit programmes as a means of discovering and addressing deficiencies in patient care. The first recorded mandatory quality assurance programme probably goes further back in history than the voluntary ones. In the Louvre Museum in Paris stands a huge block of diorite with the Babylonian King Hammurabi’s code chiselled in cuneiform script. It dates back to 2000 B.C. and in one of the passages of the code physicians are warned against incompetent practice: “. . . if the doctor shall open an abscess with a blunt knife and shall kill the patient or shall destroy the sight of the eye, his hand shall be cut off. . . “. Mandatory programmes have been neither comprehensive nor systematic. In retrospect a certain arbitrariness can be recognized with a preference for given dimensions of quality or for certain technologies [32]. Licensing of health professionals was established in many countries around the turn of the century and has expanded since into proposals for periodic recertification. Safety of drugs has also been an early concern. It led to such programmes as the Food and Drug Administration in the USA which was the model for similar government agencies in various countries. Efficacy as a concern came later in the regulatory approach of pharmaceuticals. Medical products and devices subsequently also became subject to regulatory assessment and quality control. On 28-29 November 1984 the European Economic Community organized its second conference on medical
301
products and devices in preparation
for an EEC directive on Good Manufacturing Practices (GMP). Utilization review was first introduced on a nation-wide basis in Germany as a result of the July 31, 1931 agreement between organized medicine and the sickness funds. The agreement provided for regular profiles of physicians’ diagnostic and therapeutic prescriptions. Withholding of payment was used as possible sanctions for extreme outliers in the profiles [33]. This development received so little attention that many American scholars still believe that nation-wide profiling for utilization review purposes originated in the US in the post-World War II era. Many countries have now embarked upon costly utilization review programmes. Such utilization reviews which have themselves been subject to evaluation have consistently been shown to be of dubious cost-effectiveness. Is it necessary to spend hundreds of millions of dollars on full scale utilization reviews with only a 1.269 benefit-cost ratio as demonstrated in the 1979 evaluation of the PSRO programme in the USA? [34]. The controversy surrounding the development of a supersonic civilian aircraft led the US Congress to create an agency to advise it on the environmental, social, economic and ethical implications of technology under development. The Office of Technology Assessment allegedly not only contributed to the demise of the plan to build an American version of the Concorde. Under the impetus of Senator Edward Kennedy it also rapidly attracted attention in health policy circles around the world for its pioneering work in the synthesis of health technology assessment expertise and findings. It is a model for similar agencies under development or consideration in The Netherlands and Scandinavia [35]. Consortium The debate on whether quality assurance and technology assessment should be either predominantly voluntary or mandatory, and the related question regarding the form central agencies should take, has evoked emotion for a number of years. This controversy has consumed a lot of ink without much progress in the direction of either consensus or action. Recently, the discussion has been fuelled by the move towards deregulation which is noticeable in a number of countries. Government agencies traditionally arouse suspicion amongst the professions and industry. These agencies are believed to be responsible for interference in professional prerogatives and are accused of stifling and delaying technological innovation. Moreover the medical profession argues that patient data used for assessment purposes endanger the confidentiality of the doctor-patient relationship anderode the patient’s fundamental right to privacy. The combined opposition of organized medicine and industry in the US led to the demise in 1981 of the National Center of Health Technology which had only been established in 1978 with the major legislative mandate of coordinating all governmental agencies involved in technology assessment. The consortium idea has been advanced recently in a number of countries as a model for a central agency responsible for quality assurance and technology assessment. The Institute of Medicine of the National Academy of Sciences in the USA is
302
currently elaborating proposals which were first advanced in 1980 by Relman, the editor-in-chief of the New England Journal of Medicine. The consortium would take the form of a private corporation partly funded by government and health insurers and would, in coalition with provider associations and academia, undertake cost-effectiveness studies with a strong emphasis on the measurement of patient outcome. Similar proposals have been voiced in Britain. An International Association for Health Care Technology Assessment was created in 1984 and has started an International Journal of Technology Assessment in Health Care. Such developments will undoubtedly provide leverage towards solutions in the domain of institutional arrangements for technology assessment.
The role of medical associations Programmes which attempt to improve the quality of care require at least the endorsement, and preferably the active cooperation of professional associations. Physicians as individuals and as a group tend to protect their autonomy and prerogatives. This situation has not always been beneficial for the cause of quality assurance. Although remarkable and somewhat innovative programmes have been initiated or backed by the medical profession, there are still examples of slow response and even delaying tactics which are used to resist the challenge presented by the formidable task of quality assurance. To a great extent this ambivalent situation results from decades of confrontation between organized medicine and government. When Bismarck introduced the first programme of compulsory health insurance in Imperial Germany in 1883 he set the scene for the serious confrontation which erupted many years later around issues of physician’s compensation, patient’s choice and clinical autonomy. The scenario repeated itself in succession in most European countries and was even exported to Japan [32]. In most cases the confrontation led to a stalemate which has sometimes euphemistically been called a “Pax Medica”. Self-regulation, medical autonomy, and free patient choice became the cornerstones of negotiated agreements which were often anchored in specific legislation. These legitimate concerns and principles have, however, occasionally been used to rationalize stonewalling in relation to developments such as quality assurance. Medical associations can and should play a dominant role in the development, diffusion, operation and evaluation of effective, efficient and acceptable assessment methodologies and activities. Data-poor
methods
Computers which at one time were heralded as instruments have paradoxically contributed to a steep increase of complexity society. The availability of “number crunchers” and “gigabyte” aged governments and various bureaucracies to “ask everything to know but were afraid to ask”, particularly from the health
to reduce complexity in many areas of our memories has encourthey always wanted care field.
303
Assessment methods should be restricted to minimal data-sets and to statistically valid sampling instead of encompassing the total care universe. Medical associations, by taking affirmative action and a lead in the development and promotion of such data-poor methods, would not only serve their legitimate concern for confidentiality and for efficiency in the assessment process. They would, by the same token, defuse the frequently mentioned inference of their benign neglect towards the systematic efforts for quality assurance. Strengthening
the information
system
Even data-poor assessment methods require reliable data. For a long time it has been recognized that patient care data, be they routine or part of a clinical trial, are of crucial importance as basic prerequisites for any attempt at quality assurance or technology assessment. Medical associations should be the vanguard in the development and implementation of patient care information systems. Strengthening
the management
system
Quality assurance and technology assessment efforts require more than professionalism and ethical standards by each individual member of the medical profession. The algebraic sum of the commitment of individuals who are concerned with quality aspects will not automatically generate the full potential of quality assurance. The high degree of interdependence among the professionals of various disciplines and the competing forces and paradigms of care prevalent in the health system require more than individual commitment. Diffuse medical staff organization coupled with a high level of individual autonomy is still the archetypical mode of institutional involvement of physicians in a number of European countries. The structured group judgment and peer review required by most of the modern approaches to patient information systems in general, and by the corrective management strategies required by assessment findings in particular, are virtually impossible unless there is a high level of medical staff organization with sufficient integration in the overall management of the health care institutions. More effective medical staff organization and involvement into sustained efforts of quality assurance require more than goodwill. It needs managerial know-how and a continuous updating of the knowledge and skills in the increasingly sophisticated state of the art of quality assessment. Medical societies should not only contribute towards the establishment of national entities capable of providing methodological support to budding initiatives at the rank and file level, they should also encourage the infusion of managerial expertise in their ranks. At a time when a surplus of physicians is acknowledged in a number of European countries, causing deep concern among the leadership and the rank and file of the medical profession, physicians should consider a management career and be encouraged to do so. In Europe more than 60 graduate programmes offering training and (or) continuing education in health services management are already in existence. In 1965
304
these programmes created a European Association Studies. A number of them have research capacity care assessment.
of Programmes in Health Services and activities devoted to quality of
Clinical autonomy revisited The concept of clinical autonomy and in particular the way it is being interpreted in daily practice is the linchpin of the whole quality assessment exercise. It will determine whether quality assurance is an operational reality or merely an object of lip service. The absolutist viewpoint on medical autonomy is based upon the “prerogatives”of a profession which commands a unique body of knowledge and skills to be applied without any interference from third parties and without any constraints. This viewpoint has become outmoded if it was ever ethically justified. Ethical, medical, and economic considerations have always constituted the dynamic constraints which affect the changing mandate and the concomitant degree of clinical freedom which society is willing to grant its physicians. Medical associations should actively be involved in the “listening post” function to ascertain how society values health, its risks and benefits and the costs of health care interventions. Consideration should be given to the impact that these societal values have on clinical autonomy. A pro-active posture of medical societies in this respect would not mean that they would have to forego their role in critically reviewing changing values in society. It would help to avoid the occasion when professional ethics lags behind society’s values, while providing a better vantage point to contribute constructively to the ongoing social debate. References I 2 3 4 5 6 7 8 9 10 11 12
Regional targets in support of the regional strategy for health for all. WHO-Euro document RC34/7. World Health Organization, Copenhagen 1984. Stone, A.A., The new paradox of psychiatric malpractice, The New England Journal ofMedicine, 31 I (1984) 1384-1387. Schwartz, J.S., The role of professional medical societies in reducing variations, Health Affairs, 3 (1984) 90-101. Anderson, G.F. and Steinberg, E.P., Hospital readmissions in the Medicare population, The New England Journal of Medicine, 311 (1984) 1349-1353. Evered, D. (Ed.), The value of prevention, The Ciba Foundation, Pitman, London, 1985. Willems, J.S. and Banta, H.D., Improving the use of medical technology, Health Affairs, 1 (1982) 86-102. Blanpain, J.E., Het ziekenhuiswezen van morgen: mythen en realiteit, Acta Hospitalia, 25 (1985) 5-18. Fries, J., Aging, natural death, and the compression of morbidity, The New England Journal of Medicine, 303 (1980) 130-135. Gutheil. T.G. et al., Malpractice prevention through the sharing of uncertainty: informed consent and the therapeutic alliance, The New England Journal of Medicine, 311 (1984) 49-51. Thomas, L., The lives of a cell: notes of a biology watcher, The Viking Press, New York, 1974. Galbraith, J.K., The new industrial state, Hamish Hamilton, London, 1967. The implications of cost-effectiveness analysis of medical technology. Office of Technology Assessment, Washington D.C., 1980.
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Hudson, J.I., The changing character Health Care, 1 (1983) 75-84.
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Sanazaro, P.J., Quality assessment and quality assurance in medical care, Annual Review of Public Health, 1 (1980) 37-68. Report on confidential enquiries into maternal deaths in England and Wales 1958-1960. HMSO, London, 1963.
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of quality
assurance:
activities
in acute care hospitals,
Effective
Jacobs, CM. et al., Measuring the quality of patient care: the rationale for outcome audit, Ballinger Publishing Company, Cambridge, 1976. Poulsen, H. and Thor, T., Medical care programmes, Danish Hospital Institute, Copenhagen, 1980. Taylor, W.R., et al., The use of computerized patient management problems in a certifying examination, The Journal of Medical Education, IO (1976) 179-182. Guidelines for the selection and management of consensus development conferences, National Institutes of Health, Bethesda, MD, 1983. Holland, W.W. and Karhausen, L. (Eds.), Health careandepidemiology. Henry KimptonPublishers, London, 1978. Selbmann, H.K. and Ueberla, K.K., Quality assessment of medical care, Bleicher Verlag, Gerlingen, 1982. Hegyvary, S.T. and Haussmann, R.K.D., Monitoring nursing care quality, The Journal of Nursing Administration, 6/9 (1976) 3-9. Schmitt, J.P., Risk management justification - cost-benefit considerations, The Journal of the Professional Risk Manager (1977) 26-28. Rutstein, D. et al., Measuring the quality of medical care, The New England Journal ofMedicine, 294 (1976) 582-588. Kessner, D.M. and Kalk. C.E., A strategy for evaluating health services, Institute of Medicine, National Academy of Sciences, Washington, DC, 1973. Petit, J.J., The acute abdomen: a computer-aided approach to diagnosis, State University of Groningen, Groningen. 1984. Jennett, B.. High technology medicine: benefits and burdens, The Nuffield Provincial Hospitals Trust, London. 1984. Hospital quality circle programs: a research report, Avatar International Inc., Atlanta, GA, 1983. Blendon, R.J. and Altman, D.E., Public attitudes about health-care costs: a lesson in national schizophrenia, The New England Journal of Medicine, 311 (1984) 613-615. Pascoe, D.W. et al., Patient’s attitudes to health care: a literature review, World Hospitals, 16 (1900) 165-170. Fine, D.J. and Meyer, E.R., Quality assurance in historical perspective, Hospital and Health Services Administration, 28/6 (1983) 94-122. Blanpain, J.E., Technology assessment in Belgium, France, Germany and Japan, Acta Hospitalia, 23 (1983) 37-44. Blanpain, J.E. et al., National health insurance and health resources: the European experience, Harvard University Press, Cambridge. MA, 1978. PSRO 1979 Program Evaluation. Health Care Financing Administration, Washington, DC, 1980. Banta, H.D. and Kemp, K.B.. The management of health care technology in nine countries, Springer Publishing Company, New York, 1982.