In its methods paper, the Institute for Quality and Transparency in Healthcare (IQTIG)[i] has made an attempt to define "quality in healthcare".

Anyone can define a concept as they see fit and practical, as long as they follow a few rules. They can also choose a name for it that they like. However, three things should be borne in mind:

1. The definitive description of a concept should be logical and comprehensible in itself and only use terms that are themselves already defined or can be unambiguously derived from the common language.
2. Specialised and standard languages must be taken into account when choosing a term. Certain shifts in nuances are sometimes unavoidable. If the term "quality" is used, the definition in the technical language should be taken into account.
3. The practical test must be passed.

I believe that it is very possible to apply the technical concept of quality to quality assurance in healthcare and I see no reason to abandon the internationally and professionally recognised definition. We should finally utilise the advantages of the newer concept of quality for quality assurance in healthcare. This could be particularly fruitful for the work of the IQTiG.

This should be investigated. Read the entire article

[i] Institute for Quality and Transparency in Healthcare Methodological principles V1.1 Status: 15 April 2019 https://iqtig.org/dateien/dasiqtig/grundlagen/IQTIG_Methodische-Grundlagen-V1.1_barrierefrei_2019-04-15.pdf, last accessed 2021-02-05

1 The IQTiG definition

Section 1 "Quality of healthcare" states:

"The IQTiG defines quality in the healthcare as follows:

quality the Healthcare is the degree to which the care of individuals and populations fulfils requirements that are patient-centred and consistent with professional knowledge." (emphasis mine)

The definition is connected to the preceding sentences with "therefore". There it says:

... "healthcare must be assessed according to the extent to which it fulfils these overarching objectives and the requirements derived from them".

Four questions arise:

1. What is meant by the care of individuals and populations?
2. According to the context, the requirements can be derived from the overarching objectives of some normative documents. They should be patient-centred and in line with professional knowledge. Does this exclude requirements that are not patient-centred and do not correspond to professional knowledge? Are objectives requirements? Or is the general aim to fulfil requirements? Or can they not all be derived from the overarching objectives? Who determines this and how? What are the principles of patient-centredness? What is professional knowledge?
3. How can you recognise whether the requirements are met?
4. How is scaling taken into account if not all requirements are met, but only some, or if the requirements are only partially met or - in combination - some requirements are only partially met? This would be of crucial importance for the methodological question of how quality should be assessed, perhaps even measured.

Contrary to what is claimed, the definition cannot be based on the definition in DIN EN ISO 9000:2015. It also does not match the definition of the Institute of Medicine.

2 The ISO definition

The definition from DIN EN ISO 9000:2015 is only quoted in fragments. It reads in full[i]:

"Quality: Degree to which a set of inherent characteristics (3.10.1) of an object (3.6.1) fulfils requirements (3.6.4)"

The numbers in brackets refer to the terms used in the definition, which are defined elsewhere. "Inherent" is explained in Note 2 as "inherent in an object" as opposed to "associated".

"A set" is taken from normal language as for a set of spanners or a set of cutlery consisting of a knife, fork and spoon. This refers to things that belong together but are not equivalent and therefore cannot be offset against each other.

The IQTiG definition does not include the components "a set of inherent characteristics of an object". The (general) "object" is replaced by "the care of individuals and populations". At first glance, this seems like a harmless specification to adapt the definition to healthcare. But it is not as simple as that.

The change raises three problems:

1. The "care of individuals and populations" becomes an entity that is supposed to fulfil requirements. But it is not. On closer inspection, "care of individuals and populations" combines two classes of objects that must be carefully distinguished, namely the class of individual treatment measures for (1) the care of individuals and the class of organisational structures and rules for (2) the care of populations.

If the definition is to apply to both types of care, then "care of individuals" must be separated from "care of populations" with "or", i.e. not connected by an "and".

1. The elements of the classes - the measures for (1) or rules for (2) - may or may not actually fulfil requirements. However, the class designations do not fulfil any requirements. You can only determine whether something belongs to it or not. So what should fulfil the requirements? The individual treatments or the supply of entire populations with such treatments? That remains undetermined.
2. The question arises as to how the fulfilment of requirements is recognised. The technical definition solves this as follows: an object has characteristics that can be used to distinguish whether a requirement is fulfilled or not. Characteristics are how you recognise something. They can be qualitative (or better: non-quantitative) or quantitative. In the past, quality was understood as the totality of characteristics that fulfil requirements. That was insufficient. Today (or since the revision of ISO 9000:2015), it says "a set of inherent characteristics" to make it clear that the characteristics belong together but are not equivalent.

A supply service has characteristic properties - in other words, features. The characteristics of the supply either fulfil the requirements or not (qualitatively) or to a certain degree (quantitatively). This can then be tested or measured.

The IQTiG's definition removes from the definition of quality the object of consideration and its characteristics that are ultimately to be measured or tested. How is that supposed to work?

3 THE IOM definition

The IQTiG's definition should also not be based on the definition of the Institute of Medicine [ii] are referred to. Although the term "quality" is used there, the definitional description is better suited to effectiveness. Effectiveness is the characteristic of an action that increases the probability of a desired event. The IOM reduces quality to the characteristic of effectiveness. This is entirely consistent with the view at the time (1990!). In the meantime, the IOM has discovered that other characteristics belong to the set of inherent characteristics of medical services, such as safety (e.g. with the document To Err is Human in 2000). The IOM's definition is - in the language of the IQTiG - only one-dimensional and should finally be discarded.

The methods paper states quite correctly:

"What all framework concepts have in common is that they make it clear that quality is multidimensional and cannot be comprehensively assessed on the basis of a few isolated aspects."

Apart from the fact that dimensions, aspects and characteristics are mixed up here, this realisation is reason enough to include "a set of characteristics of an object" in the definition of quality.

4 Proposal for a definition

The definition should therefore be:

Quality (of a medical service) is the degree to which a set of inherent characteristics of the treatment of individuals fulfils requirements".

Quality (of health care for a population) is the degree to which a set of inherent characteristics of a population's health care organisation meets requirements".

Everything else (what are and who sets the requirements, what are the characteristics of a treatment?) is then best explained in notes.

1. In healthcare, the quality of treatment for individuals or the organisation of care for entire populations can be considered. The object of consideration must always be identified.
2. The requirements can be defined, usually assumed or generally mandatory.

Requirements as obligations usually result from generally recognised standards such as KRINKO guidelines, guidelines of specialist societies, laboratory guidelines including the legal framework such as the Patient Rights Act, Medicinal Products Act, Transfusion Act, radiation protection, occupational health and safety, etc. for the provision of medical services. Further requirements are usually assumed in the respective social, cultural and political-economic context without the need for further justification or further explicit formulation.

Further requirements are defined by the recipient of the service himself or from his point of view, usually after a careful assessment of his needs. The recipient of the service does not have to determine the requirements based on their own knowledge. They can seek professional advice and liaise with the service provider.

Further requirements can be set by interested parties who are not themselves recipients of the service. They can be guided by general principles, principles or their own objectives.

1. Effectiveness and safety are examples of classes of design characteristics; duration, stability, robustness, coordination and continuity are examples of performance characteristics; acceptability is a class of design and performance characteristics.
2. Appropriateness is a characteristic of the selection of a procedure.

Medical quality assurance prioritises the quality of the service itself (design) and its provision (performance). The selected treatment procedure should meet the needs of the service recipient. The general social conditions of healthcare must be taken into account.

5 The object of consideration

In principle, the care of individuals and the care of populations can both be the subject of a quality assessment. One can look at the care of a patient with a pacemaker in a clinic (care of an individual person). Or the care of all insured persons in a region who suffer from an AV block can be analysed (care of a population).

But there are worlds in between.

The confusion arises from the unclear use of the word "healthcare". Does it refer to the treatment of individual patients (medical practice) or the entirety of the organisational requirements for the provision of services (health care system, public health)?

Which of the two is the subject of consideration? Is the organisation of the healthcare market being considered - which is what the OECD does with its indicators - or the individual medical services, which should contribute to health as a whole? Both can be read out. The basic task of the IQTiG is to assess the quality of services provided by service providers in the inpatient sector. But what if priorities are set, depending on "whether the focus is on the healthcare system as a whole or on the quality of care provided by individual service providers"? These are not "priorities" that can be set differently, but categorical differences whose confusion will lead to serious contradictions.

6 Comments on healthcare

One thinks of § 1 of the professional code of conduct for doctors working in Germany, which states "Doctors serve the health of the individual and the population". In the Reichsärzteordnung (1935), this was still called "Service to the health of the individual and the people as a whole".

The service to health leads to the unfortunate formation of the word "healthcare". Of course, it is not possible to provide health care because health is not a product or service that can be used to supply people like food, electricity or water. In the past, people used to talk about "health care", which still made sense insofar as they were thinking of services with which the sick were cared for or looked after so that they did not suffer any shortages.

If one wishes to summarise the provision of services for the diagnosis, treatment, prevention of illness, recovery from illness and care as healthcare, it must be borne in mind that the services themselves are then always the subject of the quality assessment and not an abstract term such as "the" healthcare of "the" population.

To make a clear distinction, the political, economic and social system in which the services are provided should be referred to as a "healthcare system". Even then, it must be clear that we use the term "healthcare system" to refer to a closed, concrete organisation, such as the English National Health System or similar systems in Ireland, Denmark and Sweden. On the other hand, we use it to describe the interaction between a number of organisations such as health insurance funds, service providers, professional associations and health administrations, which is not at all systematic, but rather chaotic, as in Germany or the USA, for example. For some time now, the term "healthcare industry" or "healthcare market" has been used to better reflect this. Because of the connotations, I prefer "healthcare system".

There is also a public health service (ÖGD), whose tasks are regulated by law. It is organised in lower health authorities (health authorities) and is therefore largely removed from market forces. The ÖGD is less concerned with the health of the individual and is more focussed on promoting and protecting the health of the population as a whole. The quality of the ÖGD can also be analysed - but this is not the task of the IQTiG.

One can therefore formulate: In every state, one can identify a more or less systematically organised and definable economic sector that provides services for the diagnosis, treatment and prevention of diseases, for recovery after an illness and for care. The production, distribution and consumption of services depend on the respective political organisation of economic relations, which can range from a state monopoly to mixed forms of regulated relationships between service providers, recipients and cost bearers to the unleashing of the market. There is no doubt that these structures have an impact on production costs, prices, local availability and - of course - on the quality of services.

However, the quality of the services is assessed regardless of whether the political framework conditions are favourable or not - otherwise it would be impossible to assess the impact of changed framework conditions on the quality of service provision! Of course, this also applies to prices and local availability.

7 Comments on the "Requirements"

The IQTiG's definition limits the requirements for the object of consideration to those that are "patient-centred and consistent with professional knowledge".

DIN EN ISO 9001:2015 defines "3.6.4 Requirement [as] "a requirement or expectation that is specified, customarily assumed or mandatory".

Since healthcare is always about patients, all requirements are somehow patient-centred. The characteristic then no longer serves to differentiate. It is nothing more than a superfluous adjective and as meaningless as "the patient is always at the centre"! If the quality of medical treatment is to be considered, the treatment process is "at the centre", if you like. Requirements must be set from the patient's perspective - anything else makes no sense. Is that what is meant by patient-centredness? But what about requirements that are not patient-centred at all?

If requirements from normative documents are described as mandatory or generally assumed, they could be listed. By no means all of them are patient-centred. It is possible that organisations, interested parties and customers (patients) may have similar, contradictory or even mutually exclusive requirements. This problem is ignored here.

Even more problematic is the restriction to conformity with professional knowledge. It remains unclear which requirements are meant. The scope and content of "professional knowledge" are far too vague. What is professionalism and where does it begin and end? Which profession? Or does it refer to a specialised discipline? Or specialised circles? Does it require a state licence to practise or other recognition? In which professional group is there a general consensus on the recognition of knowledge? And who has expressed the knowledge of requirements so explicitly that conformity can be established?

Does this exclude all requirements that are not based on professional knowledge? Do requirements have to correspond to knowledge at all?

Let's take the case of a person suffering from a rare and previously fatal cancer. Clinical treatment is expected to be effective and safe. To the best of our professional knowledge, there is no therapy that fulfils this requirement. Or there is (still) no evidence for its effectiveness - which is not the same thing. So far correct. But the requirement remains and nobody will contradict it. The requirement is made from the patient's point of view, regardless of whether it can be fulfilled. Because this is the case, the specialist disciplines search for effective means, test them, expand their knowledge and thus improve the treatment - in order to be able to fulfil the requirement.

Professional knowledge always relates to the characteristics of a service - requirements do not have to be based on professional knowledge. If "patient-centred" is to make any sense, then we must abandon the idea that a benevolent corporation limits the requirements for the quality of medical services to what corresponds to its knowledge - a knowledge that it has acquired by virtue of its professional existence.

The quality of healthcare would then be the degree to which care is what some people think it should be, without specifying who the people are and what their requirements are.

Consequently, the methods paper below also speaks more of guidelines than requirements. Institutions set guidelines, patients make demands. This makes all the difference when it comes to "patient-centredness".

8 Comment on "Characteristics and dimensions"

The confusion is further increased by the unclear use of the term "dimension".

The term "dimension" can be traced back to DONABEDIAN[iii] (and beyond). It has been repeated many times since then. In addition, "components of quality", "fundamental aspects of quality", "core objectives of the healthcare system" or "domains" have been proposed. Certainly DONABEDIAN[iv] did not understand his triad of structure, process and outcome as "measurement dimensions". Rather, he was looking for characteristics by which "good" healthcare systems could be recognised.

"Dimension" is an unfortunate term here. It usually stands for measurement, extension or dimension, e.g. of a body in terms of length, width, height or extent with regard to spatial, temporal and conceptual comprehensibility[v]. Each dimension has its own base vector that is independent of the others. In physics, the dimension indicates the power in which the three basic units (g, cm, sec) are incorporated into a certain quantity[vi] None of that is meant here.

When measuring socio-cultural healthcare systems, one can perhaps speak of "dimensions" in a metaphorical sense, as DONABEDIAN has done. However, if you want to compare the systems, you have to name characteristics that can be used to identify the differences.

Here, the IQTiG concept suffers from its unclear language: It states:

"Such fundamental requirements for healthcare are often summarised in the form of basic quality dimensions in a conceptual framework for quality".

Can "fundamental requirements" ... be summarised "in the form of fundamental quality dimensions"? What does it mean that patient-centredness should be understood as an overarching guiding principle for all dimensions? A guiding principle for dimensions? What is the difference between requirement and dimension? It is at least conceded that requirements or dimensions differ in "whether the focus is on the healthcare system as a whole or on the quality of care provided by individual service providers". However, the examples listed there do not fit either perspective:

A care system can promote or hinder the effectiveness, safety and "patient-centredness" of treatment services, but they are not themselves characteristics of the system that can be used to measure the difference.

On closer inspection, the "dimensions" mentioned are all characteristics of services that are provided in medical treatment: Effectiveness, patient safety, patient-centred care design, timeliness and availability, appropriateness, coordination and continuity. "Patient safety" is a somewhat misleading term. The word actually refers to protection against the dangers of medicine. What is meant is the safety, or rather the uncertainty, of medical services. But that is how we have always understood it.

9 Measurement of characteristics

These characteristics (and many others) can be measured or tested. This is exactly what the IQTiG should and would like to do. Section 5.1 of the IQTiG's methods paper correctly refers to characteristics, and section 5.2.3 even contains the technically correct definition of a quality characteristic! This makes it all the more incomprehensible to me why the characteristics have disappeared from the definition of quality.

The term "quality feature" is used increasingly frequently in the remainder of the methods paper. However, its use differs significantly from the usual professional usage. However, no explanation is given as to why this is the case.

After such an elaborate clarification of the terms, characteristics, quality features, quality aspects, quality models, quality indicators, quality dimensions, quality objectives and requirements get mixed up again. How are we to understand a sentence like this: "It is only with the quality characteristics that concrete requirements are placed on medical care for a specific aspect, the fulfilment of which can be used to assess the quality of care. These requirements are referred to as quality objectives."

You can measure quantitative characteristics. Qualitative characteristics can be tested. Quality as the degree of fulfilment can be estimated - it cannot be measured, nor can aspects and dimensions. Neither can objectives - they are set. Requirements are collected. Even characteristics can sometimes only be measured indirectly via indicators. Without this admission, it makes no sense to talk about testing and measurement methods.

Measurement and testing methods for design or performance characteristics differ considerably, especially when they concern qualitative or quantitative characteristics. In the case of performance characteristics, a test characteristic (indicator) is usually considered over time. Characteristics of acceptability are not always inherent and are subject to social and cultural influence. The appropriateness of a treatment can only be assessed on a case-by-case basis.

Anyone who considers all this to be superfluous hair-splitting will have to look around when, in future, an exceptionally good or inadequate degree of fulfilment of requirements is to be determined so precisely that it can be used to justify increases or reductions. It's about more or less money. Such a difference must somehow be made "noticeable", otherwise the result will be contested.

10 Literature

[i] DIN Deutsches Institut für Normung e. V. Standard DIN EN ISO 9000:2015, 0.11.2015: Quality management systems - Fundamentals and terminology. Beuth Berlin 2015

[ii] Lohr, Kathleen (ed.) (1990): A Strategy for Quality Assurance. A report of a study by a committee to desigan a strategy for quality review and Assurance in Medicare. Institute of Medicine, Division of Health Care Services. 2 vols. Washington D.C., USA: National Academy Press

[iii] Donabedian, Avedis (1980): Explorations in quality assessment and monitoring. Ill. Ann Arbor, Mich.: Health Administration Pr.

[iv] Donabedian, Avedis (1966): Evaluating the Quality of Medical Care. In: Milbank Q Milbank Memorial Fund Quarterly Health and Society 44, pp. 166-203.

[v] Duden Das große Fremdwörterbuch 4th edition Mannheim and Leipzig 2007

[vi] Regenbogen A; Meyer U. Dictionary of philosophical terms. Meiner Hamburg 2013).

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