Key words
Rhinoplasty - quality - cosmetic surgery
1. Introduction
When discussing the different areas of otorhinolaryngology, it is now crucially important to
define quality parameters for efficacy. This applies particularly to aesthetic plastic
rhinoplasty. This issue is not restricted to the benefit assessment criteria of the Federal
Joint Committee of the Health Insurances (G-BA, Gemeinsamer Bundesausschuss) or to the
regulatory instruments of the cost payers, but extends from guidelines up to evidence-based
medicine. The concept of quality becomes even more important when defining the term of
“evidence”, as for the physician this incorporates the structure of service
provision, the quality of training, overall previous treatment and follow-up, and the
interdisciplinarity - which plays a crucial role in many treatment areas.
In 1990, the Institute of Medicine of the National Academy of Sciences, USA, developed the
following definition of quality: “Quality of care is the degree to which health services
for individuals and populations increase the likelihood of desired health outcomes and are
consistent with current professional knowledge”. For the patients, the particular aspect
of this definition is that it is formulated in a patient-centred manner. The focus is not
primarily placed on the outcome of medical services alone, but on the outcome perceived by the
patient – as well as the patientʼs ideal outcome (Patient Reported Outcome, PRO)
– but always based on sound state-of-the-art medical knowledge (guidelines, evidence).
This aspect of PRO is particularly important in cosmetic rhinoplasty, as its whole purpose is to
modify the external appearance.
The term “quality” is used frequently, but tends to be exaggerated and ill
defined, particularly on advertising medical websites and social media portals, but even by cost
payers and industry. This is also evident in the increasing number of certificates and quality
labels. However, it is often unclear to the patient what this all means. What are the underlying
principles and for how long are they valid? The measurement and assessment of the quality of
medical treatment has been extensively studied, even though the methodology is rather difficult
and prone to error and may be biased by subjective influences, especially in the field of
cosmetics.
Perhaps no other field of otorhinolaryngology has been subject to more rapid changes in
specific surgical techniques than has cosmetic rhinosurgery. There have been intensive
discussion and assessment of the results of surgical techniques in interdisciplinary fora
(meetings, publications, recommendations of well-known rhinoplasty surgeons). In addition,
attempts are being made to define specific quality indicators for patients and referring
physicians by objectifying the individual expertise (minimum quantities,
lecturing/publishing activities etc.). In order to avoid possible deception, advertising
with non-verified before/after pictures is generally forbidden. Registries or quality
control mechanisms are currently either totally unavailable or inadequate information is
provided. When rhinoplasty is advertised, the quality of the service is generally unclear. Since
the patient may have to cover all the costs, they are mostly attracted by individual
recommendations. Unfortunately, comparative studies like those in oncology are extremely rare in
cosmetic surgery, particularly in rhinoplasty.
In the first part of this manuscript, the term of quality will be discussed in the context of
rhinosurgery, including with requirements, its indicators and their control, and how these are
maintained from the three main perspectives, i. e. those of the physicians, patients,
and cost payers. The second part will focus on quality development in cosmetic plastic
rhinosurgery with different surgery methods.
2. Quality of Medicine in Rhinoplasty
2. Quality of Medicine in Rhinoplasty
2.1 Requirements for quality
2.1.1 From the physiciansʼ point of view
Every physician is aware of the concept of quality and this is by no means a recent
invention. The current understanding of quality was summarised in the original definitions of
the ethical terms of medical activity (Hippocratic Oath: “I will use treatment to
help the sick according to my ability and judgment, but never with a view to injury and
wrong-doing”). This basic principle has never changed. However, even the
Hippocratic Oath could not ignore a “reformation” in the sense of how patients
now see themselves. The new and revised version of the Oath was published in 2017 in the
context of the 68th Plenary Meeting of the Medical World Association (WMA) in
Chicago: The Physicianʼs Pledge is now as follows: “The health and well-being of my
patient will be my first consideration and I will respect the autonomy and dignity of my
patient”
[1].
The physician then strikes a balance between his claims, the new self-conception of the
patients, and the interpretation of quality from the cost payerʼs point of view – that
is nowadays increasingly confused with economic efficiency. Based on this development, several
centres and institutes have been founded in recent decades under the aegis of different
medical bodies and that illuminate, define, and further develop the term of quality from a
medical point of view.
2.1.1.1 Medical Centre for Quality in Medicine (Ärztliches Zentrum für
Qualität in der Medizin, ÄZQ)
The Medical Center for Quality in Medicine (Ärztliches Zentrum für
Qualität in der Medizin, ÄZQ) is the centre of excellence of the German
Medical Association (Bundesärztekammer, BÄK) and the National Association of
Statutory Health Insurance Physicians (Kassenärztliche Bundesvereinigung, KBV) for
quality and knowledge transfer in the healthcare system. In 1995, it was founded as
“the Central Office of German Physicians for Quality Management in
Medicine”, with the aim of quality assurance of professional medical activity.
In 2003, the name was changed to “Medical Centre for Quality in Medicine
(ÄZQ)”. The objective of the ÄZQ consists in supporting the
BÄK and the KBV in fulfilling their tasks in the field of quality management in
medical activity.
The fundamental objective of the BÄL and the KBV is quality improvement in
healthcare services. The precondition is quality assurance and quality management
(QA/QM), as designed and established in all service areas in an interdisciplinary
manner. Furthermore, priorities have to be defined and the field of quality assurance and
management has to be developed in a goal-oriented manner. Guidelines and principles of
evidence-based medicine shall and must be developed in healthcare and patients have to be
involved. Healthcare providers must create suitable structures for quality management in
terms of staff and organisation, so that they can develop and enhance professionalisation in
quality management, in cooperation with all contributing parties [2]. The work of the ÄZQ is founded on evidence-based medicine, patient
safety, patient orientation, and transparency. These are all terms that will be discussed in
the course of this paper in the context of quality.
Main focuses
The focuses may be classified into four key blocks.
-
Healthcare guides
-
Guidelines
-
Guideline clearing
-
Online patient safety
-
CIRS
These four blocks show that we do not only include the physician’s perspective,
but also that of the patients and their information and safety.
This reflects the definition of the concept of quality that was published by the Institute
of Medicine of National Academy of Sciences, USA, in 1990: “Quality of care is
the degree to which health services for individuals and populations increase the likelihood
of desired health outcomes and are consistent with current professional
knowledge”
[3].
The defining feature of this statement is that it is “patient-centred”. It
is not only the outcome of medical activity that is in focus, but also the result perceived
and ideally desired by the patients.
In the literature, this aspect is defined as “patient reported outcome”
(PRO) and must be measured on the basis of the sound knowledge of medicine expressed in
guidelines and evidence. This topic will be described in more detail in Part 2 Chapter 12,
as PROs are particularly important in aesthetic surgery and especially rhinoplasty.
2.1.1.2 Association of the Scientific Medical Societies in Germany (Arbeitsgemeinschaft
der Wissenschaftlichen Medizinischen Fachgesellschaften, AWMF)
One of the first associations that aimed to define and assure the quality of medical
activity was founded in 1962 as the Association of Scientific Medical Societies
(Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, AWMF). The
German Society of Surgery then initiated a meeting of 16 scientific medical societies, mainly
to implement specialisation in medicine and the introduction of specialist examinations. In
the following 30 years, the AWMF has dealt with numerous issues in all scientific societies -
such as the education guidelines for physicians (Weiterbildungsordnung für
Ärzte) (1962, continuously since 1987), the regulation on licensing doctors (since
1970), quality management of the medical profession (since 1979 and continuously since 1993)
etc.. Since then, it has been responsible for quality improvement in education by defining
obligatory standards.
Today more than 150 scientific medical societies are represented in the AWMF that deal with
the whole spectrum of scientific and research-related politics in the field of medicine.
Together with other organisations such as BÄK, Medical Faculty Day (Medizinischer
Fakultätentag), Association of University Hospitals (Verband der
Universitätsklinika), and institutions of science promotion (e. g. German
Research Association, Deutsche Forschungsgemeinschaft), they are an important pillar in the
entire German healthcare system. As a result, as early as 1995 the Council of Experts
(Sachverständigenrat) for concerted action in healthcare assigned the AWMF the duty
to promote and coordinate the development of standards, instructions, guidelines, and
recommendations intended to enhance and define quality ([Fig.
1]).
Guidelines
Three programmes have to be differentiated in the field of guidelines. The National
Disease Management Guidelines (Nationale Versorgungsleitlinien) all correspond to the
highest level of S3. The guideline program on “Oncology” is conducted in
collaboration with the German Cancer Society (Deutsche Krebsgesellschaft) and German Cancer
Aid (Deutsche Krebshilfe) and these guidelines also have the highest evidence-based level of
S3; and thirdly, there are the guidelines of other specialist societies for verification of
diagnostic and therapeutic approaches - that are classified from S1 to S3. Independently of
the level of the guideline, they are a solid pillar in quality management, as will be
discussed later in this contribution.
The AWMF defines the term of guideline as follows: “Guidelines of Scientific
Medical Societies are systematically developed to support physicians in making decisions in
specific situations. They are based on current scientific knowledge and procedures that
have proven to be successful in practice; and they lead to more safety in medicine, but
also take into account economic aspects. The guidelines are not legally binding for
physicians and therefore neither lead to nor relieve liability.”
Under the leadership of the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery
(Deutsche Gesellschaft für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie,
DGHNOKHC), 20 guidelines at different levels of evidence have been developed. In addition,
the DGHNOKHC has contributed to the development and definition of a further 45
guidelines.
Among those 20 guidelines created under the egis of the DGHNOKHC, all levels of evidence
are found - from S1 (e. g. oesophagoscopy, sudden hearing loss), via S2k
(e. g. rhinosurgery and rhinosinusitis), S2e (e. g. sleep apnoea), up to S3
(e. g. laryngeal cancer, tinnitus). The guideline on rhinosurgery has the level S2k,
which means that it is consensus-based. It will be discussed below in Chapter 3a. This is a
significant step towards increasing quality in cosmetic plastic rhinosurgery.
2.1.2 From the patientsʼ point of view
For patients, the quality of healthcare services is often of existential significance.
National and international have been performed on patientsʼ expectations for the quality of
medical care; seven large areas may be summarised, whereby the last on the list is less
important for rhinoplasty [4]
[5].
-
Restoration of health and physical well-being
-
Respect of the patientsʼ person, respect of their subjective values and ideas
-
Sufficient and comprehensible information
-
Emotional support and empathy
-
State-of-the-art expertise of medical treatment, but also in other fields, e. g.
nursing care
-
Inclusion of partner, family, and friends
-
Continuity of the treatment, understood as staff-related continuity within the medical
institution, but also as continuity between the single healthcare services, e. g.
support at the time of discharge from the hospital into the home environment
Patients have an intense need for information about quality in healthcare services in these
dimensions, as is evident in publications from the beginning of the 2000s [6].
Patients increasingly want to receive precise information about the institutions and
physicians who will provide the highest quality. This desire is reflected in in the patientsʼ
new self-conception and self-confidence. They do not see themselves only as users of medical
services, but they want to be understood as equal partners of the physicians. In the context
of rhinoplasty, this is very important, as these patients are perceived as being extremely
challenging.
There seems to be an increasing uncertainty about the situation in the quality of medical
care. Even 18 years ago, two thirds (!) of the population stated that the situation for
patients in healthcare services had deteriorated in recent years [7].
In comparison to other industrial nations, results for Germany for 2015 were a mixed bag. In
some areas, Germany has a leading position (e. g. GP care), but one of five persons
asked thinks that the German healthcare system needs to be completely revised [8].
Patients increasingly think that they should be able to retrieve transparent information
about structural processes and a physicianʼs and/or hospitalʼs quality of results,
particularly as this information is becoming more and more readily accessible in the internet
or social media. Patients can gather additional information about medical treatment and
quality from friends or practitioners. Patient satisfaction and experiences may also be
published in social networks and the internet and these reports have excited increasing
attention - even if their accuracy and authenticity generally cannot be verified.
According to a survey, one third of patients stated that they had chosen the medical
institution in accordance with their physicianʼs recommendation [9]. 20% relied on the recommendations of relatives and friends; about
18% had already experienced previous stays in the respective hospital; 17%
mentioned the general reputation of the institution as basis of their choice; for 12%,
the proximity to their home was decisive; 6% selected the hospital based on internet
information. Moreover, self-help groups are important information portals for their members
and other interest groups.
Physicians who refer their patients to a colleague, directly or indirectly, give a direct or
indirect recommendation to their patients. The physician’s recommendation often
results from their own experiences in collaboration with certain colleagues, departments,
wards, or information retrieved from a professional network or the feedback of their own
patients.
Studies on quality management and evidence-based healthcare have been performed in different
medical fields. These confirm that it is not enough if the evaluation exclusively concentrates
on a concentration of treatment methods, procedures for physical symptoms and treatment
outcomes [10]. That is why the measurement of treatment
efficacy focusses increasingly on the psycho-emotional characteristics of the
physician-patient relationship, communication, and decision-making on a partnership basis (see
above) [11]
[12]. The physician should be aware of each patientʼs
situation and value systems, how he experiences the disease and how he copes with it. Only
then can the optimal treatment be identified [13]. From the
patientsʼ point of view, it is absolutely essential for therapy to establish a stable and
confident relationship with the physician and that the physician understands his individual
needs and requirements [14]. A self-confident patient
expects that a competent physician will understand and be interested in his concerns, and will
readily provide explanations, effective therapies, and specific information [15]. This trend is also observed in surgical disciplines.
Therefore, the parameters of success are no longer restricted to the definition of
evidence-based standards, but also in the patientsʼ subjective assessment of therapeutic
processes – and this is another important quality criterion [16]. This complex of communication, interaction, understanding,
assessment etc. is most relevant for cosmetic rhinosurgery, as this modifies the shape of the
nose – right in the middle of the patientʼs face. The patientsʼ expectations have to
be adequately assessed.
In the cosmetic context, the above mentioned subjective ratings (PROs) play a crucial role,
as beauty is in the eye of the beholder and partially depends on fashion and the overall
social situation. Furthermore, the assessment of the mentioned criteria provides knowledge
about the actual quality standard of the service – both as perceived by the patients
and in the subjectively experienced improvement in health status. At the same time, the
assessment of the patientsʼ needs is a consistently patient-oriented and effective instrument
for quality assurance that provides a valid measure of the whole process and the outcome
quality from the usersʼ perspective. The resulting development into generic (general) and
disease-specific subjective measurement instruments - so-called PROMs (patient related outcome
measurements) – is underway and will be discussed later in Chapter 12 with a special
focus on rhinoplasty.
2.1.3 From the cost payersʼ point of view
As regards cost payers, a distinction must be made between statutory and private health
insurances as well as statutory accident insurances and employersʼ liability insurance
associations (Berufsgenossenschaft, BG). These are described and defined in different social
insurance codes (Sozialgesetzbuch, SGB). Their contents are defined differently - which is
also expressed in different guiding principles.
2.1.2.1 Statutory health insurance (Gesetzliche Krankenversicherung, GKV)
One important pillar of the statutory health insurances is economic efficiency, as can be
found in the first chapter of SGB V. According to chapter 2, §3, sentence 1,
health insurances provide the insured individuals with services, after taking into
account the economic efficiency. Quality is only mentioned in the following paragraphs, in
the statement that treatment methods, medication and therapeutic products of a specific
treatment institution are not excluded. The quality and efficacy of the service have to
observe generally accepted medical knowledge and medical progress.
Service performance and the claim of efficacy are defined as follows in §12 (1):
The services have to be sufficient, appropriate and cost-effective; they must not exceed
what is necessary. Services that are not necessary or effective may not be claimed by the
insured individuals, the cost payers are not allowed to perform these services, and health
insurances will not approve them.
This shows the dilemma of the statutory health insurances, since all their services have to
observe the claim of cost-effectiveness. The misinterpretation that cost-effectiveness is a
quality parameter will have to be discussed later.
2.1.2.2 Private health insurances (Private Krankenversicherung, PKV)
In contrast, private health insurances are not defined in the social insurance code as a
law, but the insurance relationship is constituted by a private contract. The principles are
regulated in the insurance contract act and the insurance supervision act
(Versicherungsvertragsgesetz, VVG; Versicherungsaufsichtsgesetz, VAG), both of which are
generally applicable.
For private health insurances, the insured event is the medically necessary treatment. The
explicit imperative of cost-effectiveness does not exist in private health insurances. It is
rather the case that the single contract between the individual patient and the insurance
company specifies the intensity and extent of the treatment costs to be borne.
2.1.2.3 Statutory accident insurance (Gesetzliche Unfallversicherung, GUV)
The definition of responsibility of the statutory accident insurances and the employersʼ
liability associations is diametrically opposite to that of health insurances. In contrast to
statutory health insurances, the maximum appropriate measures have to be taken. Their
responsibilities and activities are regulated by law in the social security law (SGB VII).
Their focus is not on the general provision of health service provisions, but on the
prevention, rehabilitation, and compensation of the insured people.
Accordingly, the services must be of high quality so that the insured person can resume
work as rapidly as possible. According to the social security code (SGB VII), the
responsibility of statutory accident insurances is to restore the health and performance of
the insured individuals after accidents at work or occupational diseases - with all
appropriate measures and to compensate the patients or their surviving relatives by payments.
No chapter explicitly mentions cost-effectiveness. In addition, quality is not mentioned
clearly but automatically results from the special institutions of GUV and employersʼ
liability associations - such as BG hospitals. These are highly specialised in the acute
treatment and in rehabilitation of specific injury patterns.
3. Quality Indicators
3.1 Quality criteria and quality indicators
All investigations on the quality of provided services are based on the documentation and
analysis of quality indicators. These aim to assess the quality level achieved by the service
provided (aim achieved/aim partly achieved/aim not achieved). Quality
indicators try to make the non-measurable conception of “quality in medical
treatment” more tangible by checking single quality criteria for significant treatment
aspects (e. g. laboratory, radiology etc.).
3.1.1 Aspects of treatment provision
The aspects of treatment provision include structures, processes, and outcomes of medical
services that are highly relevant for the quality of medical treatment and which therefore
should be assessed in the context of quality management. A series of suggestions have been
made for the selection of aspects of treatment provision that should be included in medical
quality management.
So treatments should be assessed that are known to be
-
Performed with high frequency, represent a high risk for the patients, or are often
associated with complications;
-
Possibly associated with over-, under- or mistreatment;
-
Subject to high treatment variability, if the treatment has recently changed
significantly, that are of high financial relevance or where practical considerations are
positive - such as the general measurability and variability as well as the acceptance by
the group of affected individuals;
-
Provide the possibility actually to improve treatment and health-related outcomes, are
highly interesting for users or possibly improve the decision finding process (in favour or
against a certain service provider);
-
May serve as indicators for comprehensive treatment problems.
Except for the last aspect, all these are relevant to the field of internal and external
nasal interventions. They are performed in high numbers and it is often unclear whether the
therapy is adequate (e. g. the topic of septoplasty). Furthermore, there is great
patient interest, since respiration and smelling are essential for the quality of life and
because the effect is subject to a dynamism that can be measured. The cosmetic aspect is added
because it does not primarily belong to the treatment aspect.
3.1.2 Quality criteria
Quality criteria for the assessment of service performance are those attributes that are
expected to be typically fulfilled in the context of high quality medical treatment.
A list of such criteria has already been published in 1998 by the Joint Commission on
Accreditation of Healthcare Organizations (JCAHO) [17].
These criteria are still appropriate, as well as being internationally acknowledged and
applied.
-
Accessibility of care
-
Appropriateness of care
-
Continuity/coordination of care
-
Efficacy of care (ideal conditions)
-
Efficacy of care (treatment in healthcare practice)
-
Efficiency of care (cost-effectiveness)
-
Patient-orientation of care
-
Safety of the care environment
-
Timeliness of care
The WHO “World Health Report 2000” refers to these criteria and warns
against applying these rather instrumental quality criteria to an overall assessment of
healthcare systems. For such an overall assessment, the WHO mentions three key objectives of
good healthcare: health, fair financing, and patient-orientation [18].
Quality criteria for single treatment aspects (e. g. rhinoplasty) might be used for
example in internal quality management of an institution in order to define specific quality
objectives.
Examples for quality criteria:
-
Timeliness of diagnostic testing
-
Information of the patients about their findings, planned treatment, their rights and
obligations
-
Training and education of the medical team
-
Implementation of statistics about diagnoses and treatments
-
Adequate use of diagnostic and therapeutic measures
-
Waiting times (hospitalisation/before physician
contact/treatment/in hospitals or practices)
3.1.3 Quality indicators/reference range
Quality indicators are measures intended to make a difference between good and poor quality
of structures, processes and/or outcomes of treatment. They are auxiliary parameters
that indirectly depict the quality of a unit by numbers and ratios. They could also be called
quality-related parameters.
The quality of a treatment is a very complex phenomenon that can be generally described by
several indicators. Therefore, the overall quality of patient care, of a service provider, or
of an institution cannot be assessed on the basis of a single quality indicator. Instead,
single indicators only show partial aspects of quality. So to assess a certain treatment, it
is reasonable to summarise several indicators or quality criteria in the form of indicator
profiles
Indicators are suitable to influence the quality of patient care, or surgical treatment, and
also the treatment outcome from the patientsʼ perspective. Furthermore, quality indicators are
useful to evaluate the objective achievement of medical treatment itself based on the outcome
quality visible in the patient (evaluation function).
The evaluation is performed by means of previously defined values of “good
quality”, the so-called “reference ranges”. The reference range is the
interval in which the manifestation of a quality indicator is defined as
“good” or “normal”. In rhinoplasty, the assessment of good
quality is rather difficult because the objective criteria of breathing and smelling have to
be weighed against the subjectively perceived cosmetics. As is well-known, beauty is in the
eye of the beholder and often varies between surgeon and patient.
Depending on various factors, different reference ranges may be assumed for a specific
quality indicator. These factors are mainly patient-related (e. g. the extent of
change, breathing, smelling) or surgeon-related (e. g. experience, number of
operations, specialisation). In particular, the indicators for assessment of the outcome
quality react sensitively to the above-mentioned factors. The discrimination of quality
indicators and their respective reference ranges depend mainly on their sensitivity and
specificity. If a reference range is optimally defined, nearly all quality problems are
identified (high sensitivity) without producing too much unnecessary alarm (high specificity).
The predictable positive and negative values then depend on the incidence of quality
problems.
The realisation of programs for development and implementation of quality indicators is
mainly influenced – as are the guidelines – by their quality, practicability,
and financing. That is why “quality criteria” have been defined for quality
indicators that partially correspond to quality criteria for guidelines (see Chapter 4.1.1.)
[19]
[20].
3.2 From the physicianʼs point of view
Quality criteria that play a significant role in patient care from the medical point of view
are mainly based on what physicians have seen and learned during their education as well as in
exchanges with colleagues, during congresses, meetings, or information from scientific
societies. It may be important to consider the type, intensity, and duration of the
specialisation of their colleagues who are closely associated with the respective teaching
hospital or special department. Furthermore, publications, lectures, or teaching activities may
also influence quality indicators from the physiciansʼ perspective. However, in the specific
field of rhinoplasty, an increasing number of hands-on courses are available worldwide. It is
possible to attend different meetings on this topic nearly twice per week. The quality of such
courses is not controlled and minimum standards do not exist; the courses may be offered by any
physician. Nonetheless, this is not a unique problem of rhinosurgery, but unfortunately is
found in all disciplines of medicine. From all the single parameters and experiences, a
physician generates his own personal quality indicators or criteria in order to rate other
colleagues, which could be summarised in the sentence: “Where would I go? Who would I
trust?”
In addition, the so-called specialist standard - based on two pillars - is crucial for
quality analysis.
One pillar represents the number of treated diseases from a specific discipline
(e. g. ENT) and thus the physicianʼs experience in this discipline. The other pillar
represents either the variation in the individual spectrum (e. g. general ENT) or the
diagnostic and therapeutic specialisation of the physician and his expertise in this discipline
(e. g. rhinosurgery, ear surgery, allergology, cancer etc.). These areas often lead to
a low rate of side effects and complications and to a high outcome quality that is communicated
to the referring physician by the patients and that is meanwhile even required by them and the
cost payers.
In particular, the outcome concentrates on an optically good postoperative result –
which does not say anything about the inside of the nose. Only an ENT specialist may confirm
the quality by endoscopic examination. However, it must be mentioned that the objectively
assessed outcome does not need to correlate with the patientʼs subjective perception, in
particular in the field of breathing, smelling, and cosmetics. The experience of a surgeon in
rhinosurgery is also reflected in the number of cases of revision and reconstruction, as
experience and expertise with high case numbers and expertise are particularly important.
3.3 From the patientsʼ point of view
Indicators for the choice of a physician are manifold and depend on the disease as well as on
the discipline. The decision for an individual gynaecologist incorporates other priorities than
that for a cancer surgeon. Nonetheless, patients too have indicators to help them to assess
quality. Quality-conscious patients do not only assess the medical, therapeutic, nursing care
provided and the outcome of the treatment, but also the information flow, communication with
service providers, the impression of the staff (friendliness, reliability, competence,
punctuality, waiting times), the interaction with all staff members of a practice or hospital,
the access and the organisation of the practice as well as offers of support (see above) [21].
In this context, two relevant areas are seen that may be described as “hard”
and “soft” factors. Hard factors are those that are objectifiable by facts or
for which the patient can present objective arguments.
Hard factors are:
-
Professional experience
-
Degree of education
-
Specialisation
-
Equipment of a practice
-
Staff
-
Hygiene
On the other hand, there are so-called soft factors that correspond to the rather subjective
perception of the patients.
-
Personality of the physician
-
Physician listens
-
Physician allows questions
-
Physician explains
-
Physician respects the individual patient and his problems as patient
-
Physician is interested in the patientʼs health-related problem
-
Physician takes his time
-
Confidence between physician and patient
Based on this perspective, BÄK, KBV, and ÄZQ published a general checklist
for patients in 2015 that intends to illuminate and summarise this area [22].
In the preface, the following aspects are summarised: “You have to see a doctor but
you do not exactly know where to go. Your physician should be competent and trustworthy. You
want to be taken seriously, and you want to feel well cared for by the practice team. However,
it is difficult to assess if a practice may meet all these expectations. That is why the
checklist entitled “What are the criteria of a good doctorʼs office?” has been
developed. This booklet will help you to find the right office for your needs. You may read
what you can expect from a good practice. Whether a physician is actually the right one for
you, finally depends on the confident relationship, which cannot be created by checklists but
by a respectful and open interaction”.
As assistance, the following questions might be asked:
-
Am I addressed in the medical office in a friendly and respectful way?
-
Does my physician take me and my concerns seriously?
-
Are my personality and my privacy observed?
-
Do I receive understandable and neutral information and consultation?
-
Do I receive hints about further reliable information sources and consultation offers?
-
Does my physician involve me and my wishes in all decisions?
-
Does my physician accept that I want to have a second opinion in cases of doubt?
-
How can I see if my physician and the team attend training courses and quality
programs?
-
Is a highest level of security for my treatment observed in the practice?
-
Do I have access to my files without any problem?
-
Does the medical office cooperate with other physicians?
The problem is that patients are not informed about which aspects have to be understood as
objective or subjective criteria and how they have to be classified. The list is more like a
subjective general assessment. Unfortunately, the checklists give no information about
experience, skills, specialisation, education etc.
For cosmetic rhinosurgery, other “quality indicators” are relevant for the
patients that may result from objective criteria, but also very frequently come from subjective
criteria.
The list below does not claim to be complete, but the following criteria play a major role
– as often in the field of cosmetics:
-
What is the surgeonʼs special field?
-
Where did he learn rhinoplasty?
-
Is he a member of a scientific society?
-
How often does he perform this kind of surgery?
-
Is he specialised in rhinosurgery?
-
Is he specialised in revision surgery?
-
What about the price of the operation?
-
What do others report about this surgeon?
-
What about the rating in the respective portals or fora?
-
How informative is the homepage?
-
How is his presence in social networks?
-
Is the physician likeable?
-
etc.
In this way, an accumulation of “facts” is created that consciously or
unconsciously influence the patients in his choice of a surgeon and that are considered
subjectively as quality indicators. In particular, emotional aspects that are confirmed by
other peopleʼs statements – regardless of whether they can be verified or not - make
any objective criterion obsolete, independently of the type of intervention.
3.4 From the cost payersʼ point of view
Since German reunification, cost payers have focused on cost-effectiveness. If a service
provider works efficiently and effectively, the quality should be appropriate. This was the
approach that cost payers have propagated since the beginning of the 1990s. They only focused
on cost-effectiveness and the responsibility for the decreasing quality of medical care was
attributed to the service providers [23].
However, this was too short-sighted, because medical care does not correspond to the
industrial production of goods. Moreover, the cost payers had to acknowledge this fact after
several years of cost savings, and other factors came more and more to the foreground that were
more likely to be an indicator of quality than cost-effectiveness alone.
Structural specialisation to only a single disease or injury pattern and the associated
“high” number of cases are now considered as possible indicators of high
quality. For example, recent publications on the outcome quality of head and neck cancer
therapy confirm that there is significant association between overall survival and the
structural quality of the treatment centre with supposedly always the same therapy. These
factors have only recently played a role in clinical trials [24].
Further examples for improved quality in organised and predefined structures are found in
breast centres, burn centres, stroke units, or CI centres. This list could be continued
endlessly for all disciplines. It is of course also the case that physicians have to employ the
key terms of “minimum numbers” or “minimum quantities” in their
annual negotiation with cost payers if they are to ensure adequate funding. This is eminently
the case with plastic aesthetic rhinosurgery, as only a few physicians perform more than 30
complete inner and outer rhinoplasties per year.
The cost payers and the service providers thus have conflicting priorities in terms of
comprehensive, adequate care of the population on the one hand and the requisite and currently
high quality due to specialisation for specific diseases and injuries on the other.
Specialisation reflects a higher level of experience and expertise and should be associated
with fewer side effects or complications or better overall survival (see above).
In this way, the economic costs may be lower in the long term, due to shorter hospitalisation
and partial displacement to outpatient care - which is less cost-intensive. This would then
lead to greater cost-effectiveness - the declared primary goal of cost payers.
4. Control and Quality Assurance
4. Control and Quality Assurance
4.1. Methods and instruments of quality management
When a quality problem has been identified and specific objectives have been defined to
alleviate it, there are numerous methods of quality management (QM) to achieve these quality
objectives [25]. The content, design and organisation of QM
procedures should adequately consider the specific quality problem, the defined objectives, and
the context of care. Quality management systems/procedures are often quite disparate
with respect to structure and conceptual spectrum, so that a direct comparison of the criteria
is difficult.
To be successful, QM procedures must be carefully and planned and their cost-effectiveness
assured. Quality assurance instruments may encompass all or only some phases of the quality
improvement cycle [26].
For quality management in medical care the following issues are of high priority:
-
Quality circles with creation and/or revision of guidelines
-
Ring trials
-
Quality check in single cases (on a random basis)
-
Second opinion procedures
-
Data collection and evaluation of parameters (e. g. complications)
-
Structured external comparison (e. g. benchmarking)
-
Etc.
These procedures are not generally established in aesthetics.
4.1.1 From the physiciansʼ point of view
4.1.1.1 Quality objectives for patient orientation from the physiciansʼ
perspective
Most regulations in medical quality assurance concern measures of structural quality. In
individual areas of quality assurance, they generally lay down the physiciansʼ qualification,
education and training, as well as the required equipment. The guidelines define the details
of the qualifications that a physician or his colleagues should have, or which technical
equipment is approved in order to invoice certain services, but do not allow any statement
about the quality of a medical service. Appropriate guidelines are completely missing in the
field of rhinosurgery so that these interventions might also be performed by general surgeons
etc. In cosmetic surgery, this is a general problem because there is no sufficient legal
regulation defining and protecting these therapies and applications. Reports in the media
about alternative practitioners who perform cosmetic interventions, internists performing
surgeries etc. are well-known.
In a high number of quality assurance areas, quality management should check and control
the quality of the procedure and outcome. The outcome quality is characterised by the
verification of the success or outcome of the examination or treatment.
4.1.1.2 Practical implementation of patient orientation in QM
Thorough and understandable information
It is absolutely essential in quality management that the patients should be provided with
detailed and comprehensible information, as this provides the basis for making informed
decisions. The patient who comes to see a doctor and does everything the god in the white
coat says without questioning him has become very rare (see above). More and more patients
want to be informed about diagnostic and therapeutic measures and options, and who want to
understand the implications, and finally make the decision together with their physician.
This corresponds to the central statement of the concept of participative or shared decision
making. On the basis of shared information, physician and patient make a joint decision;
they enter into a “therapeutic alliance” [15]. In the field of self-payers and cosmetics, this is found comparatively
frequently, as patients pay for the services out of their own pockets and thus expect high
quality treatment.
Patients often understand only 50% of the information they receive from their
doctor [27]. Whether a patient understands the information
given about the benefits and side effects of a suggested treatment option depends on how
this information is provided [28]
[29].
Even a very thoroughly conducted informative discussion is no guarantee that patients have
understood the contents and will remember them. Many patients are not able to correctly
recall the contents of a conversation when they leave the doctorʼs office. That is why
patients should be able to take home everything they have learned about findings and
possible therapy options - as well as further care - in the form of a piece of paper that
summarises the information [22]. In rhinoplasty, processed
pictures might help to visualise a desired outcome. However, the patient always has to be
informed about the fact that this is a draft and not a guaranteed result.
What is important is that the patient takes something home that has been conceived
individually for him. In this respect, quality is more important than quantity. An
individual piece of information appears to be more professional and personalised than a
photocopied plan or the usual information brochure.
Information about treatment options
For physicians and patients, making evidence-based decisions requires an understanding of
probabilities. No examination is 100% safe; no treatment is always and completely
effective. So when making a decision, physician and patient always have to rely on
probabilities. Experts assess benefit and risks in a different way from laypeople. Experts
justify their evaluation for a clearly defined patient group (based on the according trial);
patients are more likely to expect a yes/no decision. Another obstacle for the
communication of benefit and risks is the so-called “framing effect”. This
means that the decision depends on the manner in which information/options are
presented in a positive or negative way.
Quality of physician-patient communication
In order to have a successful physician-patient communication, various aspects have to be
taken into account [30]
[31]:
-
Creating an undisturbed environment
-
Establishing a confidential working relationship
-
Empathy
-
Conflict management
-
Authenticity of the relationship
-
Observance of the basics of communication science
-
Identifying and communicating oneʼs own limits
Patient care
-
Orientation of the care to current scientific standards and guidelines
-
Patient orientation, safety, collaboration, information, and consultation
-
Structured treatment processes
Practice management/staff/organisation
-
Regulation of the responsibilities
-
Team orientation (e. g. safety at work, training and education)
-
Practice management (e. g. appointments, data protection, hygiene, escape
plan)
-
Communication processes (internal/external) and information management
-
Cooperation and management of the interfaces of care
-
Integration of existing quality measures into the internal quality management
All these are areas that a rhinology patient regard as important, particularly in the
communication of findings and therapy options. In most cases, the patient who deals with
aesthetic correction of his nose is at least informed by the internet, and is influenced by
other peopleʼs opinions and by the media with regard to the desired optical outcome
– even more than he is aware.
4.1.1.3 Guidelines and quality management
For several years, the relevant literature has mentioned the close relationship between
guidelines and quality management [32]. Guidelines are one
of the most important tools of quality management. The integration of guidelines in QM
programmes is one of the most effective strategies to implement guidelines.
In the context of quality management, guidelines further serve as basis for the work in
quality circles [33], as reference for quality objectives,
quality parameters and indicators [19], as the basis for
process descriptions as well as working instructions, e. g. in the form of clinical
treatment pathways [34]. The introduction of a working
quality management system may assure the implementation of guidelines in practical routine
and thus lead to the desired improvement in quality [35].
At the same time, guidelines are a relevant part of modern information management in medical
work and may help patients to reach balanced and joint decisions (see above).
4.1.1.4 Intention and objectives of guidelines
In addition, guidelines are intended to present extensive current knowledge (scientific
evidence and experience) of specific treatment problems, to assess their methodical and
clinical aspects, to clarify contradictory perspectives, and to define the current process of
choice by balancing potential benefits and harms.
The primary objective of guidelines is to improve the quality of medical care by
communicating knowledge. After taking into account available resources, guidelines should aim
at promoting good clinical practice and at informing the public, at finding a more rational
basis for decisions in medical care, at strengthening the patient’s position as
partners in the decision making process, and at improving the quality of care.
Fig. 1 Organisation chart of the AWMF. © AWMF online – Das Portal
der wissenschaftlichen Medizin
Guidelines are the basis for defining parameters and indicators that make the quality of
medical care measurable and allow differentiation between “good” and
“improvement needed”. Such quality indicators are an important tool for the
evaluation of treatment services and outcomes in routine medical work, for internal quality
management, and for external quality comparison.
4.1.1.5 Effectiveness and quality of guidelines
It has been demonstrated that guidelines have a favourable effect on the quality of both
processes and outcomes in healthcare [35]. The efficacy and
thus ultimately the benefit of an individual guideline, however, depends on its quality and
implementation. Up-to-date criteria must be fulfilled by high quality guidelines and are
internationally defined in a standardised way [32]. For
Germany, these criteria of methodical quality are published in form of commented checklists -
the so-called German Guidelines Assessment Instrument (Deutsches
Leitlinien-Bewertungs-Instrument, DELBI) [36].
On the one hand, DELBI should help users of guidelines and other interested people to
submit guidelines to a methodical check-up and thus to evaluate their validity. On the other
hand, authors of guidelines ensure that the guidelines correspond to international standards,
by checking their orientation to DELBI.
Three fundamental aspects are emphasised in this context:
-
Composition of the guideline board: representation of the user community
-
Evidence basis: systematic search, selection, and evaluation of the literature
-
Methods of development: systematic evidence and consensus base
The evidence base is especially important for the scientific legitimation of a guideline,
while the contribution of the users and structured consensus finding are crucial for
acceptance and implementation. To help the user to achieve a broad view, four classes of
guidelines are distinguished (see [Fig. 2]) [37]. The practicing physician must be able to recognise good
(i. e. valid, current, practicable) guidelines. This is indeed a precondition for
their use in evidence-based medicine.
Fig. 2 The S-classification scheme of the AWMF. © AWMF online – Das
Portal der wissenschaftlichen Medizin
Legal aspects of guidelines
In contrast to directives, guidelines are not binding [38]. Before a specific recommendation is implemented, it must be confirmed that it
is appropriate to the circumstances (e. g. comorbidities of the patient, available
resources). The Federal Supreme Court (Bundesgerichtshof, BGH; sentence dated April 15, 2014
– VI ZR 382/12) has confirmed that guidelines are not legally binding, in
particular because they cannot replace expert opinions. In principle, an active physician
has to be informed about the guidelines that are relevant for his discipline. Furthermore,
he should document justified deviations from guideline recommendations in individual cases -
in the context of the patientʼs documentation. Deviating from a guideline alone will not be
understood as negligence unless the respective procedure is so well established that no
responsible physician would disregard it. However, this does not mean that a guideline could
not have further consequences in a legal process - even if it is not normative for the
confirmation of negligence. For example, it may lead to a reversal of the burden of proof,
e. g. if a physician has not observed a guideline, he might be required to prove
that the damage of the patient has not been caused by non-observance of the guideline.
Guidelinesʼ significance in legal processes usually depends on several factors, especially
on the extent to which they are scientifically proven, and whether they represent an expert
consensus, and have been published by an authorised group or institution. Guidelines will
not generally give final answers, even if they allow only a low level of flexibility in
terms of their application. Medicine is progressing, the speed of development is extremely
high so that every single guiding principle has to be assessed in the light of both the
specific health problem as well as the particular circumstances of the respective patient.
Sometimes competing guidelines are found, e. g. created in different hospitals or
regions; in other cases, expert statements may be used in legal processes to question the
authority of a guideline. For all these reasons, the courts will not automatically equate
the observance of guidelines with good medical practice [36].
4.1.1.6. Use of guidelines in quality management – implementation of
guidelines
The creation and publishing of guidelines alone is not sufficient to assure that they are
applied in daily medical routine. Implementation of guidelines means the transfer of
recommendations into individual action or behaviour of physicians, patients, relatives
etc.
In order to assure that this transfer is successful, several complementary measures
generally have to be taken that are specifically coordinated for the identified problem
areas. These measures concern educational, financial, organisational and/or
regulatory strategies [39].
For implementation, it is not only decisive that the guideline is available, but also that
the users work according to the content and adapt it to their individual needs and
circumstances. In the outpatient area, successful examples of such adaptations are performed
in the context of quality circles [40]
[41].
4.1.1.7. Implementation of guidelines in outpatient care
The observance of evidence-based guidelines is legally binding in several statutory
healthcare programs, particularly for the structured treatment of chronic diseases (according
to § 137f SGB V and since the amendment in April 2007 of the
“Hausarztzentrierten Versorgung” (HZV) according to § 73b SGB V).
Structured treatment programs have to be based on consistent therapy recommendations,
although the necessary evidence-based consensus guidelines are not available in Germany for
all relevant diseases. With this background, the German Medical Association
(Bundesärztekammer) initiated the so-called National Programme for Disease Management
(Nationales Programm für Versorgungsleitlinien, NVL) in 2002 and published the first
disease management guidelines (asthma, COPD, diabetes type 2, and coronary heart disease).
The aim of this joint program of BÄK, KBV, and AWMF is the implementation of
evidence-based guidelines in the context of structured healthcare. The recommendations
reflect the interdisciplinary consensus of all medical societies and disciplines contributing
to the care of a specific patient group, as based on the best available evidence. The program
of NVL contains targeted instruments and measures to distribute and implement NVL, in order
to allow effective implementation in practice. One focus is on the fields of quality
management, quality indicators, and education. If establishing NVL also has a demonstrable
financial effect, it may be expected that legislation and cost payers will strive to
implement them for all disciplines. This implies that medical therapeutic freedom is
jeopardised.
Specific medical information for laypeople should be consistent with existing medical
guidelines and provide people seeking advice with support when making decisions during all
phases of medical care (diagnostic testing, therapy, follow-up). The information should
provide valid data based on evidence-based medicine. In this context, patient information
brochures are successful instruments for the implementation of guidelines.
4.1.1.8. Guidelines in rhinoplasty
The guideline that is relevant for rhinoplasty (AWMF registry n° 017/070)
was written in June 2000 and revised in January 2016. It corresponds to the standard of S2k
and will be revised again in January 2021. It was developed as a consensus paper under the
authority of the DGHNOKHC by 11 physicians from the disciplines of otorhinolaryngology,
plastic surgery, and maxillofacial surgery. Thus it meets the DELBI criteria in terms of the
representation of the user circle (ENT, plastic surgery, maxillofacial surgery); moreover, it
is structured and consensus based (S2k), and is being continuously developed (revision in
2021).
In the description of the objectives of the guideline, it is stated that the aim of the
guideline was to promote high quality specialist treatment of patients with malformation of
the inner and outer nose associated with functional or relevant cosmetic impairment. It is
intended to help to reduce associated, disease-related morbidity, to support the rational
application of diagnostic and therapeutic procedures and to curb disease-related
socio-economic factors. The objectives are to achieve reasonable and appropriate diagnostic
testing and therapy based on the current state of scientific knowledge.
This description of the objectives is essential because this also defines the minimum
quality requirement from a medical perspective that is relevant for correction of the inner
and outer nose or the functional and cosmetic elements. In the proper sense of the word, they
are intended to “guide” the treating physician to develop the best concept
for treating the patients. The S2k guideline on rhinosurgery has high legitimation with
respect to implementation, due to the representative expert group and the structured
consensus finding. On the other hand, its scientific legitimation is weaker, as no evidence
is confirmed. In cases of S2e, the situation is inverted ([Fig. 2]). In the long run, what we need is a higher level of classification, so that
aesthetic plastic rhinosurgery can be established as S3, similarly to laryngeal cancer.
However, this may also mean that “fond habits” can no longer withstand
scientific analysis and have to be given up. This challenge has to be accepted by all ENT
surgeons, in particular with regard to the changes in surgical techniques over the last 50
years (see part 2), which have significantly improved patient care. This should awake the
interest of all physicians, as it reflects the benefits of medical progress – without
which patients would still be treated as they were 50 years ago.
The well-informed patient also refers to guidelines and sometimes confronts the physician
with the question as to whether the procedure corresponds to the guidelines. They are an
integral part of the daily routine of rhinosurgeons and should be well-known. From an
cosmetic point of view, they play a significant role that is explicitly requested by the
patients. However, it should also be remembered that the quality of life is only mentioned in
the section of the olfactory function in the rhinosurgical guideline and not in other areas
(breathing, cosmetics etc.) of nasal function. Perhaps this aspect should be included in the
revised version of 2021.
4.1.1.9. Quality and patient safety
All patient safety is aimed at preventing undesired events. The safety culture in each
institution is then decisive. This safety culture can be established by specific measures and
the commitment of individuals. There is an interaction between the safety culture and
measures for improvement in patient safety. Safety culture in medicine means that an
organisation (e. g. the doctorʼs office) permanently works on all levels so that
patients do not experience any (avoidable) undesired event related to healthcare.
4.1.1.10. CIRS medical
CIRS medical is the reporting and learning system of German physicians for critical events
in medicine. “CIRS” stands for Critical Incident Reporting System. It is
anonymous, safe, and allows helps the user to learn from mistakes, errors and critical
events. It is available to staff members in healthcare services. All safety-relevant events
occurring in medicine may be reported by staff members of the healthcare services. These may
be mistakes, near-accidents, critical events, or even undesired events. As examples, the
“Manchester Patient Safety Framework” and the “Safety Attitudes
Questionnaire” may be mentioned.
The reports must not contain data that allow the user to draw conclusions regarding the
people or institutions involved (name, location etc.) [42]
[43]. The author does not know of any such focused
questionnaires in otolaryngology or plastic surgery.
For cosmetic rhinosurgery, one approach would be to anonymously collect undesired or
critical events related to surgery and follow-up, and then to evaluate and discuss these.
Specific conclusions could then be incorporated in order to draw specific conclusions that
may enter in the guideline. This information should definitely be available to every
specialist in this area of work.
4.1.2. From the patientsʼ point of view
For patients, the last paragraphs of the last chapter are equally important. Quality
management/quality assurance, questionnaires, and also reporting
“critical” events are rated favourably, as patients know that medicine is a
highly sensitive area where errors and mistakes happen. Therefore it is important to know how
they are coped with – in the patientsʼ interest.
4.1.2.1. Patient surveys in quality management
Surveys are an important instrument to collect feedback about the patientsʼ satisfaction
and to receive ideas for improvements. If possible, they should be conducted regularly with
validated questionnaires.
The German questionnaire relating to satisfaction in outpatient care/quality from
the patientsʼ perspective (“Zufriedenheit in der ambulanten Versorgung –
Qualität aus der Patientenperspektive”; ZAP) has been developed for anonymous
written surveys of adult patients. By means of this questionnaire, patients who undergo
specialist or general treatment and know the doctorʼs office, e. g. who had at least
two treatment contacts, can rate the practice in the following areas: organisation,
information, interaction, competence, participation in decision processes, confidence,
treatment quality, and general satisfaction with the physician. It becomes obvious here how
the so-called “hard” and “soft” factors described in Chapter
3.1.2. appear again and how they have been included by the G-BA.
4.1.2.2.Patient complaints as instrument of quality management
Complaints are not automatically a breach of confidence between the physician and the
patient. Moreover, complaints can provide a significant source of information to improve the
quality of treatment. Complaints expressed by patients are relevant feedbacks to all parties
involved in medical treatment. Therefore, complaints have to be heard, evaluated, and
answered. In addition, in cases of complaints or proposals, the treating physician has to be
the contact person for the patient.
Individual patient complaints mainly require that the needs, anxieties, worries, annoyances
etc. identified by the patients are registered and that someone tries to support them
individually.
If the main issue is to find out the patientsʼ opinion in support of treatment quality
management possible options include: assessment of experiences and satisfaction collected by
means of feedback (e. g. suggestion box) or standardised feedback based on systematic
patient surveys. The patient rating depends on different dimensions, such as expectations and
needs, ideas and assumptions about the treatment result, individual attitudes, social
background, education, real experiences in a situation, and the health-related results; it is
therefore reasonable to assess these parameters.
In rhinosurgery, these issues must not only be addressed in conversations and discussions
prior to surgery, but explicitly in the follow-up. The patientsʼ expectations and needs and
ideas and assumptions are particularly important – as these are often diametrically
opposed to the physicianʼs perception. Even if the surgeon has clearly explained the
limitations of a treatment and of a result or if the initial findings only allow limited
options, these can collide with the expectations, wishes, assumptions, and imagination of the
patients in the postoperative setting. Key factors include social background, circumstances,
and education (see Chapter 12) [44].
For these reasons, it is essential to clearly formulate the questions and to take into
consideration numerous other aspects (summarised in the literature) about the development of
survey instruments. It is recommended to use already existing validated questionnaires that
may be adapted to the needs and objectives of the respective treatment under qualified
supervision [45].
4.1.3. From the point of view of the cost payer
Because of the increasing pressure on costs, and the patientsʼ increasing demands for more
information, there have been increased demands for more transparent health information
(e. g. internet). To meet this need, different institutes have been established since
2000 that aim to determine and assure quality. In this context, we will discuss two
institutions that directly or indirectly influence medical care and treatment.
4.1.3.1. Institute for Quality and Economy in Healthcare Services (Institut für
Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG))
Quality and economy – from the perspective of the cost payer, these are two
decisive factors for a good and effective healthcare system (see above). In order to achieve
this goal, it is important to objectively check the advantages and disadvantages of medical
services for the patients. The IQWiG has the official mandate to evaluate the advantages and
disadvantages of medical procedures, for example to compare different medications or surgical
procedures. The IQWiG does not conduct its own clinical studies with patients. Moreover, the
Institute systematically looks for those trials where the respective comparisons are
described and that provide sufficient evidence-based and reliable results. On the basis of
this systematic research, a summarising report is developed for the authorities. The
institute publishes all results on its websites and addresses experts of the healthcare
sector as well as the public. The mandates may only be assigned to the IQWiG by the G-BA or
the Federal Ministry of Health. The results are published as reports, dossier evaluations or
potential evaluations. The institute may also work independently on questions of general
importance. Thus, the IQWiG creates reports about the benefit or additional benefit of
medical measures from a medical and a cost-related perspective and may issue
recommendations. The IQWiG, however, does not make decide whether the costs of a service have
to be paid by health insurances. Only the G-BA is allowed to make these decisions.
4.1.3.2. Institute for Quality Assurance and Transparency in Healthcare Services
(Institut für Qualitätssicherung und Transparenz im Gesundheitswesen;
IQTiG)
In 2014, the IQTiG was founded by the G-BA - in the context of the act about the
development of financial structures and quality in statutory health insurance (Gesetz zur
Weiterentwicklung der Finanzstruktur und der Qualität in der gesetzlichen
Krankenversicherung; GKV-FQWG) - as an independent scientific institute for quality assurance
and transparency in healthcare services based on § 137a SGB V. In accordance with the
law on hospital structure (Krankenhausstrukturgesetz) and on behalf of the G-BA, it develops
concepts for planning-relevant quality indicators, such as surcharges and deductions in
quality-oriented remuneration, and evaluates quality contracts according to § 110a
SGB V. Beside the development of quality assurance instruments, it is also guaranteed that
current quality assurance procedures will be continued and developed. The development and
implementation of procedures, the external quality assurance of the treatment, the setting of
criteria for the assessment of certificates and quality labels as well as the publication of
results are intended to ensure that quality is comparable in different hospitals. In 2019,
the IQTiG conducted a total of 24 quality assurance procedures in the fields of visceral and
vascular surgery, cardiology and cardiosurgery, transplantation medicine, hygiene and
infection management, gynaecology, perinatal medicine, orthopaedics, trauma surgery and
nursing care.
The quality assurance procedures compare and evaluate quality-related aspects in the fields
of complications or undesired events, revision interventions due to complications, and the
survival of the patients. The principle aim of these procedures is to improve the procedures
for these interventions, in order to enhance patient safety, reduce complication rates during
and after the interventions, together with diseases caused by the intervention. In this way,
costs can be reduced.
4.1.3.3. Quality and costs – the example of septorhinoplasty
The cost payers analyse single surgical methods based on quality-adjusted life years
(QALY). By assessing the patientʼs subjective estimation before and after surgery by means of
so-called PROMs (see Part 2 Chapter 12), an improvement or deterioration in the quality of
life is estimated. A cost-benefit analysis is then derived. This consists of the quotient of
the costs divided by the gain in the calculated quality of life. Analysis in the field of
septorhinoplasty show a mean QALY gain of 0.04 points [46].
The significantly higher published values of 0.08 always referred to combined surgery of the
nose including the paranasal sinuses [47]. In this way, the
QALY in the area of rhinosurgery is very good in comparison to other interventions such as
otology with 0.01 [48] or cochlear implantation with 0.035
[49]. Apart from the discipline of otorhinolaryngology,
higher scores are only found in the fields of cardiac catheters and total hip replacement
(0.1) [50].
For a state-wide base rate of € 3539,12 in 2019 for
Baden-Württemberg and a valuation ratio of 1.139 for complex septorhinoplasties,
revenue of up to 4031,6 EURO is earned. Taken in relation to the QALY gain of 0.04, the ICUR
(incremental cost utility ratio) is calculated as about € 100,000 per gained QALY.
This high ICUR is not due to the expensive therapy, but rather to the low QALY gain. Cost
payers will increasingly include these calculations to help them to decide whether an
intervention is economically justified or not. Similar developments are already seen in Great
Britain, where specific interventions are no longer paid by the health insurances from a
specific age (e. g. hip replacement) or the decisions are made individually in
particular cases (e. g. septorhinoplasty) [51]. By
implication, this means that from the cost payerʼs point of view the costs of the
intervention have to be lower (lower DRG) or that the gained QALY would have to clearly
increase with unchanged costs. One must always bear in mind that the QALY is the subjective
perception of the patient and does not reflect the objective result. Thus, the medical
quality only plays an indirect role because significant demographic features have an impact
on the patientsʼ perspective and these are distinct from the treatment and may influence the
pre- and postoperative analysis (see Chapter 12) [44].
5 Evidence-based Medicine
5 Evidence-based Medicine
5.1 Definition and background
The idea of evidence-based medicine originated in the second half of the 18th
century when British physicians developed the concept of “medical arithmetic”
[52]. For the first time, term was first used in an article
entitled “An attempt to improve the Evidence of Medicine” published in 1793 by
the Scottish physician George Fordyce [53]. In Great Britain,
one of the first controlled clinical trials was conducted by James Lind who published the
results of his attempt to treat scurvy in seamen with oranges and lemons as early as 1747.
In German-speaking countries, the Hungarian physician Ignaz Semmelweis (1818–1865),
who was working in Vienna, was first author of the introduction of “systematic clinical
observation” in medical research (1848).
In 1972, Professor Archie Cochrane, a British epidemiologist, published the book entitled
“Effectiveness and Efficiency: Random Reflections on Health Services”, which
marks the beginning of current international efforts around “evidence-based
medicine”. His further publications led to increasing acceptance of clinical
epidemiology and controlled trials. An international network on efficiency assessment in
medicine was named in his honour – the Cochrane Collaboration [54]. Despite its historical roots, evidence-based medicine is a
rapidly developing young discipline and its positive effects are currently proven. This
evolution is in full swing and will achieve completely new dimensions, especially under the
aspect of digitalisation and the worldwide collection and access of data, under the terms of
“evidence-based” and “precision medicine” [55].
David Sackett is a pioneer of clinical epidemiology and scientifically substantiated
healthcare. He defined “evidence-based medicine” (EbM), as practiced since the
1990s, in these words:
“Evidence based medicine is the conscientious, explicit, and judicious use of
current best evidence in making decisions about the care of individual patients. The practice
of evidence based medicine means integrating individual clinical expertise with the best
available external clinical evidence from systematic research”
[56].
Individual clinical expertise means the skills and the discernment that physicians acquire by
experience and clinical practice. A gain in expertise is reflected in many different ways, in
particular, however, in making accurate diagnoses and in thoughtfully and empathically
identifying and considering the particular situation, the rights, and preferences of patients
in the context of clinical decision making during their treatment (see Chapter 3.1.2).
“Best available external evidence” describes the clinically relevant research
- often basic medical research, but in particular patient-oriented research - on the accuracy
of diagnostic procedures (including physical examination), on the relevance of prognostic
factors, and on the effectiveness and safety of therapeutic, rehabilitative, and preventive
measures. External clinical evidence leads to the re-assessment of formerly accepted diagnostic
tests and therapeutic procedures and replaces them with those that are more effective, more
accurate, and safer.
External clinical evidence may complement individual clinical experience but it will never
replace it and vice-versa. It is especially this individual expertise that decides if external
evidence can be applied in an individual patient and – if yes – how it can be
integrated in the decision. In the same way, each guideline and each procedure has to be
verified in terms of how and if it improves the clinical condition of the patients.
EbM is definitely no cookbook medicine. EbM requires a so-called “bottom-up
approach” that combines best available external evidence with individual clinical
expertise and the preferences of the patients. This means that the basic idea always consists
in first solving circumscribed, detailed partial problems and, on this basis, then solving
larger, higher ranking problems etc. The single partial solutions are combined
“bottom-up” until the entire problem is solved. In conclusion, the concept of
EbM is not compatible with strict adherence to a cookbook recipe for patient treatment.
But there are also critical voices expressing the fear that cost payers and politician make
use of EbM to reduce expenses in healthcare (see above). This would not only be an abuse of the
concept, but also a fundamental misunderstanding of the financial consequences. Physician who
practice EbM will identify and apply the most effective procedures in order to maximise the
quality and duration of life of their patients. This may tend to lead to an increase in costs
instead of reducing them.
EbM is supported by the three pillars of individual clinical experience, values and desires
of the patients, and the current state of clinical research.
The procedure in EbM is subdivided into five steps:
-
Translation of the clinical problem into a question that may be answered by
scientific investigation.
-
Systematic research of the literature for adequate trials
-
Critical evaluation of the evidence over all identified trials
-
Application of the acquired knowledge in respect to the specific clinical
situation
-
Self-critical evaluation and adaptation, if needed, of the current procedures
This five-step procedure requires training and it is not always feasible within the daily
routine of patient care. The important element of EbM is the systematic, prompt, and unbiased
consideration of study results (see above).
5.2 Levels of evidence
Evidence-based medicine should be understood as support for different therapeutic questions
that allows sufficient room for the implementation of the physicians own clinical experiences.
EbM is not only limited to randomised, controlled trials and meta-analyses. It also consists of
the research for the best scientific evidence to answer the clinical question.
In order to learn more about the accuracy of a diagnostic procedure, well-conducted
cross-sectional trials of patients are required who are clinically suspected to suffer from a
certain disease – and no controlled trials.
For prognostic questions, methodically accurate follow-up studies of patients are needed who
have been enrolled in the study in a uniform, early stage of their disease. The necessary
evidence is sometimes found in basic disciplines such as genetics or immunology.
The study of therapeutic methods should avoid non-experimental approaches because they often
lead to false-positive conclusions as regards the efficacy of treatments. Since randomised,
controlled clinical trials and especially systematic reviews of these studies most probably
provide correct data and false conclusions are less frequent, these are now the “gold
standard” for answering the question of whether therapeutic measures do more good than
harm. However, for some questions, no controlled trials are necessary (e. g. successful
interventions compared to otherwise fatal situations) or when there is no time for clinical
trials. If no controlled trial was conducted for the particular situation of the patients, the
next best external evidence has to be found and taken into account.
According to the recommendations of the AHRQ (Agency for Healthcare Research and Quality),
the levels of evidence of I to V are differentiated as well as grades that reflect the clinical
perspective. Trials categorised as Ia have the highest level of evidence, trials classified V
the lowest. The higher the level of evidence is, the better is the scientific justification for
the resulting therapy recommendation (grading).
-
Level Ia: at least one meta-analysis based on methodically high-quality RCTs
-
Level Ib: at least one large, methodically high-quality RCT
-
Level IIa: at least one high quality trial without randomisation
-
Level IIb: at least one high quality trial of any other type (e. g.
experimental trial)
-
Level III: more than one methodologically high quality non-experimental trial such as
comparative studies, correlation studies, or case control studies
-
Level IV: opinions and convictions of reputed authorities (from clinical experience),
expert commissions, descriptive studies
-
Level V: case series or one or more expert opinions
Weighting and recommendation of levels of evidence with grading (modified according to AHCPR
1992, SIGN 1996).
Grade Level of evidence
A Ia or Ib, of first rate clinical importance
B IIa, IIb, III, of second rate clinical importance
C IV, of third rate clinical importance
D V, of fourth rate clinical importance
5.3 Evidence-based medicine and rhinoplasty
As already described in the previous chapters, there have been few high quality controlled,
randomised studies, even in the context of septal surgery. Only isolated publications are
available on single procedures in rhinosurgery [57]. Multiple
meta-analyses about different areas of rhinoplasty have been published (see part 2) that are
based on single trials or results of single surgeons without randomisation or control. As in
all surgical disciplines, it should be our motivation in rhinoplasty to face this challenge.
Firstly, this would have to be organised at a national level and the results compared. This
could then be followed by an international exchange. We may face this task with optimism, as
there have been extremely positive developments in cosmetic and functional rhinosurgery in
recent years, to the benefit of our patients and including the new S2k guideline. Furthermore,
it should be mentioned that EbM has already been applied since the mid1990s in internal
medicine, surgery, psychiatrics, and general medicine [58]
[59]
[60]. In this context, it must be recalled how - for example
- the therapy of laryngeal cancer has completely changed during the last 20 years on the basis
of evidence-based data [61].
6 Conclusion – Part 1
From the perspective of all three protagonists (physicians, patients, cost payers), the
quality in healthcare must be transparent, permanent, scientifically proven, and cost-effective.
To some extent, the focus is on very different areas. Physicians want to have the best care for
their patients that is possible with their skills and knowledge. Patients want to have the best
quality with least side effects, most pleasant outcome, and manageable costs – at least
as self-payers. Cost payers want to have a quality that does not exceed the cost frame and that
is compatible with efficiency and savings. This is a balancing act that can hardly be performed
without underrepresenting the one or other party. In order to find an agreement and to justify
this with solid data, evidence-based data should also be developed for cosmetic rhinosurgery.
However, this should be performed independently from financial influence, old habits, or
unrealistic expectations and only pure data and facts should be presented and interpreted.
7. Part 2 – Quality of Surgical Methods in Rhinoplasty
7. Part 2 – Quality of Surgical Methods in Rhinoplasty
The second part of this manuscript deals with transferring these results to the field of
rhinosurgical interventions. Beside normal medical ethics, emotional and soft criteria play a
major role in the patientsʼ perception of changes in external appearance and shape.
Cosmetic rhinosurgery seems to develop in discrete eras, which are mostly initiated by
pioneering publications describing new surgical techniques. A turning point in the last 40 years
was the work entitled “Aesthetic Rhinoplasty” published by Sheen in 1978 [62]. Sheen heralded the first important paradigm shift since the
publication of Jacques Josephʼs book in 1931 [63], and helped
to establish rhinoplasty as genuine cosmetic surgery with preoperative analysis, surgical
planning, and performance. Josephʼs reduction concept was replaced by balanced surgery combining
resection and transplants; and the occasionally unattractive results that led to revisions could
be significantly improved. Rhinosurgeons were no longer rated by the speed of surgery but by the
cosmetic outcomes.
Until now, the classical disciplines such as physiology and anatomy have surprised us with new
insights, despite the common idea that “everything has already been verified and
examined” so that these new insights continuously improve our understanding of the shape
and function of the nose and thus modify and refine surgical approaches. In general, the
procedure for rhinosurgery has developed enormously and become more precise in recent decades.
Important progress could be made by acknowledging the relationship between anatomy, nasal
cosmetics, and surgical techniques. As an example, the nasal tip with its ligaments and the
osteocartilaginous nasal dome have received new attention.
While open suture techniques for the nasal tip excited lively interest, Cakir succeeded in
demonstrating that similar results could be achieved via a closed approach with better control
and lower morbidity [64]. The aim was to preserve the nasal
ligaments and to only minimally resect the cartilages. This was possible by a subperichondral
access with less important postoperative swelling and reduced numbness, as well as less scarring
- which would facilitate possible revision also for the future.
Other turning points in the philosophy of nasal tip surgery were the publications by Ozmen
[65] and Gruber [66] who
advocated sliding or the preservation of the alar cartilages, as until that time it had been
common practice to generally resect the cephalic part. Based on these innovations, the so-called
“alar notching” was less visible after surgery and “alar rim
grafts” were more rarely applied. Another example is the problem of “alar
malposition”, that was considered as one of the most difficult deformities and had to be
treated with “alar transpositioning” and “lateral crural strut
grafts”. Davis showed convincingly that “medial tensioning” was
sufficient to meet the requirements without performing transposition or alar resection or using
additional grafts [67].
Anatomical studies on the osteo-cartilaginous dome showed that the bony hump was only a small
bony cap that could be removed, with preservation of the underlying cartilaginous dome [68]. The keystone area that was always in the focus turned out to
be a type of semimobile cartilaginous joint that may be changed from being convex to straight by
resecting the cartilaginous septal support [69].
In the focus of surgical quality, four areas will be illustrated that have been openly
discussed at meetings and symposia for many years and that may be considered as relevant to
quality.
-
Open vs. closed access
-
Costal vs. auricular cartilage
-
Piezo vs. traditional osteotomy
-
Preservation rhinoplasty vs. non-preservation
8. Open vs. Closed Access
8. Open vs. Closed Access
Looking back in history, it is seen that even before World War II, open and closed accesses
were practiced. By the end of the 19th century, open operations were performed, as a
closed approach was impossible with the available lighting and instruments. Only after the
technical development of surgical lights and headlamps after World War II, were closed
techniques increasingly established because no scars were then visible, so that surgeons
considered this approach to be more elegant. Nearly all rhinosurgeons who learned functional and
cosmetic rhinoplasty in Europe from the 1960s employed a closed access. The introduction of
endoscopic surgery further fostered the closed technique.
After World War II, the open technique was increasingly disregarded in Europe, but further
developed step by step in the USA. After the closed access had reached its climax in popularity,
another change in direction was triggered by articles published by Goodman at the beginning of
the 1970s [70]. His results also convinced other rhinosurgeons
in the USA, so that this technique was rapidly distributed in the literature [71]
[72]
[73].
In the 1990s, the open techniques - that had already been developed and established in Germany
by Diefenbach and Joseph - returned to Europe and started their triumphant progress in the field
of cosmetic rhinoplasty.
This surgical revolution was supported by three pillars:
-
Open access allowed better visualisation for analysis, surgical techniques, and
teaching.
-
New surgical techniques such as nasal tip sutures, reconstruction of the inner vault or the
septum were developed that were impossible or at least very difficult with a closed
approach.
-
The open access reduced the learning curve for beginners, so that rhinoplasty became one of
the most frequently performed cosmetic surgeries.
However, even in 1992, Aiach wrote that open surgery is only an option for revisions,
difficult cases, or nasal tip surgery and should never become a standard procedure [74]. This view is now completely outdated since more than
70% of all rhinoplasties are performed with an open access. Of course, some people
considered that the open technique was a surgical setback to the 19th century and
that it had to be considered as surgical cardinal sin [75].
But these voices have rapidly fallen silent for the above reasons.
A scientific quality analysis was not performed at that time for the two accesses - as would
be required today - because the techniques were presented at congresses, advocated by
experienced surgeons of their time, and established in the hospitals in the context of medical
teaching and education.
Quality was discussed - especially with respect to the scar at the columella, and whether the
outer appearance was better or poorer with the one or other technique [76]. A discussion with regard to the quality of patient comfort,
breathing, function, smelling, quality of life etc. took place only much later. Finally there
was a consensus only in the perception that revisions, trauma noses or cleft nose deformities
could be better analysed and operated through the open technique (see above).
8.1 Quality of the external or cosmetic outcome
During the “renaissance” of the open access, Friedman and Gruber postulated
in 1988 that the long term results were better and longer lasting. Due to the open exposure of
the anatomy, precision, accuracy, and the predictability of the outcome were superior to the
closed approach. In their analysis, the focus was primarily placed on the nasal skeleton and
the nasal tip. Even Gruber in his time considered that the aspect of the scar at the columella
was no longer a problem, because optimised suture techniques led to significant improvement in
the postoperative situation [77].
In 2017, Yagmur, Demir et al showed in 91 patients that the columella scar does not have a
significant influence on the patientsʼ satisfaction with regard to rhinoplasty in particular
and physical perception in general [78].
Nonetheless, the learning curve and thus the existing risks and side effects of both
techniques must not be neglected. In the context of a closed as well as an open access, there
is the risk of an over-resected nasal bridge or nasal tip, as well as the occurrence of a
narrow inner nasal valve. In addition, further risks of a narrow or unstable outer nasal valve,
open access may lead to an unstable nasal tip or a short nose. Furthermore, it must be
mentioned that the number of patients with multiple rhinosurgeries with open access is
significantly higher than with the closed technique [79].
When open rhinosurgery was being re-established, and beginners in rhinosurgery learned the
open access without reluctance, they often had little experience in preparing the tissue in the
area of the nasal tip. This led to previously unknown traumata and circulatory disorders, which
initially reduced the quality of the open access. The advantage of the open exposition of the
nasal tip and the nasal bridge was at the same time associated with severe disadvantages.
Anatomical structures came to the fore that had been forgotten by the surgeons because the
closed approach did not primarily touch these structures. Despite their influence on the
function and cosmetics, the nasal ligaments have been overlooked for a long time [80].
As an example, the “Pitanguy ligament” had been described by Pitanguy in
1965, who emphasised its role in the context of the thick postoperative nasal tip [81]. Furthermore, the vertical Scroll ligament is known to
stabilise the internal nasal valve by means of the transversal nasal muscle and supports the
function of the nasal dome [68].
In addition, in 1996 Toriumi described the course of veins, arteries, and lymphatic vessels
of the nose in a very interesting publication combining clinical evaluation, anatomical
dissection, and histological examination [82]. Arteries,
veins, and lymphatic vessels run in or over the muscular aponeurotic tissue layer of the nose.
Thus, the risk of severe swelling of the nasal tip or even skin necrosis in this area was
significantly reduced by strict preparation below the muscular aponeurotic layer, which led to
improved quality.
8.2 Quality of the functional and endonasal outcome
As regards the function and the cartilaginous and bony architecture, the outcome depends on
the severity of the deformity. Simple deviations, spurs etc. can be corrected without any
problem via a closed modern septorhinoplasty; open access would mean clear overtreatment. More
severe deformities of the inner nose may require extracorporeal reconstruction or restoration
of the cartilaginous or bony nasal skeleton, and then the closed technique reaches its limits -
so that open access is generally accepted as standard procedure. However, in 2016, Berghaus
reported that there is still enough space for a closed access even in modern rhinoplasty and
that this provides additional advantages [83]. In particular,
in the context of the reconstruction of the septum, the inner and outer nasal valve, the
anterior support, and the nasal tip, open access is superior to the closed approach, also due
to the extensive use of cartilage transplants (grafts).
We know of no studies that compare the quality of the mere functional results. However, the
superiority of the open access in reconstruction and revision surgery has been demonstrated and
is generally acknowledged (see above).
8.3 Quality of the subjective perception of the patients
Interestingly, despite scientific discussions over many years that even extend to today,
there have been no significant changes in the subjective perception of the patients. Various
scores and questionnaires (NOSE, ROE, DAS-24) do not show significant differences. A recent
article from 2019 published by Gökce Kütük and Ok with more than 90
patients showed that the psychosocial stress level of patients after successful rhinoplasty was
significantly reduced [84]. This value, however, was
completely independent of the type of access (open vs. closed), the indication (cosmetic vs.
functional), or the type of intervention (primary vs. revision). Together with other
prospective follow-up trials in this context, this makes it clear that the approach is not
decisive but the outcome is - especially in the perception of the patients [85]. The repeated significance of the quality of the outcome vs.
the quality of the procedure becomes very obvious.
9. Costal vs. Auricular Cartilage Transplant
9. Costal vs. Auricular Cartilage Transplant
One important pillar of traditional rhinoplasty was dorsal resection with destruction of the
keystone area, followed by immediate reconstruction by means of osteotomies and dome
reconstruction. Despite all surgical improvements in the context of cosmetics and nasal
function, smaller revisions or even larger second or third interventions cannot be totally
avoided, even now. Apart from trauma history, there are revisions where costal or auricular
cartilage is used in the reconstruction of the nasal bridge or the nasal tip. The technique of
preserving the area of the nasal bridge could probably reduce the number of nasal bridge
revisions and minimise the necessity of dome reconstruction (see Chapter 11) [86].
Although numerous improvements have been achieved, we may still repeat Rollin Danielʼs
question: “Why are we doing an operation that can produce such a destructive result that
a rib graft reconstruction becomes necessary following a primary case performed by an
experienced surgeon?” [87]
Cartilage grafts may be taken (for example) from the rib, followed by primary reconstruction
of the base and subsequent reconstruction of the secondary structures is an accepted procedure.
Structures that resist contraction forces in the long term play a major role [88].
In order to allow a more detailed assessment, rib grafts and auricular grafts have to be
analysed separately. Rib grafts may then be subdivided into autologous and irradiated homologous
cartilage. Furthermore, the surgical development has to be taken into account, as well as the
dicing type, either with (diced cartilage in fascia, DCF) or without fascia (free diced
cartilage, FDC). Since a complete description of the cartilage grafts for the entire nasal
architecture would go far beyond the scope of this manuscript, the focus has been placed on the
nasal bridge.
9.1 Quality of the external and/or cosmetic outcomes
9.1.1 Autologous cartilage chips (ACC)
The harvest of the autologous rib cartilage is one of the oldest procedures to reconstruct
the nasal bridge. The first publications on this subject appeared at the end of the 1960s
[89] and in the mid1970s [90]. Meanwhile, this technique has been established and refined. With rib cartilage
for augmentation of the nasal dorsum, results from very long observational periods are now
available that give a good overview of the external results. A meta-analysis encompassing 10
studies with nearly 500 patients and a mean follow-up period of nearly three years showed that
the complaints related to deviation, hypertrophic scars, and revision [91]. This aspect is worth being mentioned because these three
aspects are perceived both by patients and their environment. The deviation (3.1%) of
the chips is often disappointing for the patients. The hypertrophic scar (5.5%) at the
corpus is a stigma and a cosmetically limiting sequela of the lifting intervention, especially
for females. Other complications - such as resorption, infection, shifting of the rib chip
etc. - only play a minor role and amounted to less than 0.6%. A revision rate of
14%, one in seven 7 (!), must raise the question as to whether there was no other
option. This aspect will be discussed later in the manuscript.
9.1.2 Irradiated homologous cartilage chip (IHCC)
The first article published on IHCC appeared in 1961. Dingham et al. illustrated the
possibility of conserving homologous costal cartilage chips by means of irradiation [92].
In 1993, Kridel reported excellent results with irradiated homologous cartilage chips in
more than 120 augmentations of the nasal dorsum [93]. Kridel
published additional results in 2009 [94] and 2017 [95] that confirmed that the sum of side effects in 943 patients
was only 3.25%. The percentage of resorption was 1.01% and of deviations
1.06%. Kridelʼs overall conclusion was positive, as the rates of side effects were
very low, there were no lifting comorbidities and IHCC is less expensive than ACC.
A large retrospective comparative study including histological examinations of ACC and IHCC,
was also published in 2017 [96] and investigated 83 patients
in follow-up. Costal chips were applied measuring 30–40 mm in length, 4–6 mm
in thickness, and 8 to 10 mm in width. A 10-fold higher resorption rate (30%) was
observed in cases of IHCC. This was of course also reflected in the optical outcome, which was
significantly inferior to ACC. In contrast to Kridelʼs publications, these numbers are
consistent with the general literature that reported resorption rates between 1.4% and
75% for IHCC, depending on the follow-up period. The differences in deviation or
infection were not statistically significant. No objective differences were observed in the
functional outcome.
9.1.3 Quality of the subjective perception of the patients regarding ACC and
IHCC
The above mentioned results are reflected in the quality of the treatment as subjectively
perceived by the patients. In Kridelʼs publication of 2009 [94], the high subjective rating improved for the internal and external outcome from
91.3% to 94.2% in the mean follow-up period of 7.8 years.
In a study published by Wee et al. more than 75% of patients in both groups reported
that they were “satisfied” or “very satisfied” by the
postoperative outcome [96]. However, due to the high
resorption rate of IHCC, the intergroup score was significantly lower in cosmetics. There was
no significant difference between the groups with respect to function. In this respect,
satisfaction amounted to 95%, as in Kridelʼs cohort. Once again, this confirms that
patient satisfaction depends primarily on the outcome and not on the method itself.
9.1.4 Diced cartilage in fascia (DCF)
After 10 years of experience, Erol published the method of diced cartilage for the nose as
so-called “Turkish delight” [97]. He wrapped
the cartilage in Surgicel® and not in fascia. In their publication of 2004,
Daniel and Calvert also reported clinical difficulties and explained this by a foreign body
reaction on Surgicel® - that had been used until then [98]. After 2006, fascia was used, as Calvert could prove
histologically that diced cartilage in fascia was superior to Surgicel®
[99]. More recent publications experiment with cellulose
instead of fascia, however, the application in humans still needs to be approved [100].
In the long-term observation after 25 years, Erol came to the conclusion that the method was
optimal with Surgicel®, as there were no side effects – even though
the method with fascia had by then been widely used [101].
In a further development, Tasman replaced the fascia with fibrin glue and blood components, in
order to stabilise the dices. He achieved satisfying outcomes in more than 100 patients [102]. For all further developments of the classic costal
cartilage chip, it must be said that patients perceive the application of diced cartilage
– independent of the type of wrapping – as being more comfortable than rigid
chips. This is due to the lesser rigidity and deviation [103].
9.1.5 Free diced cartilage (FDC)
Gubisch et al. have further developed the procedure by using “free diced
cartilage” (FDC, 2017) [104]. To enhance both
augmentation and camouflage, they compared the application of FDC either without any wrapping
including fibrin or with fascia or as classic DCF. The revision rate in the DCF group was five
times as high as in the FDC group. This may certainly also be due to the fact that FDC has to
be diced in smaller and thinner parts than DCF - nearly like powdered sugar. FDC is a good
option - in particular for covering irregularities and for the final touch up. Because of its
recent introduction, patient ratings are not yet available.
9.1.6 Auricular or concha cartilage
As early as 1984, Münker suggested that the use of auricular cartilage as double or
triple sandwich may be an alternative to costal chips for the augmentation of the nasal bridge
[105].
However, problems occurred from cartilage luxation, with unfavourable external outcomes.
Furthermore, due to the reduced donor quantity, the augmentation of the nasal dorsum was
limited. Therefore, for auricular cartilage too the way was paved for diced cartilage, as it
had been proved in animal experiments that preservation of the perichondrium led to better
vascularisation and stabilisation of the transplant [106].
In addition, with auricular cartilage, a harvesting morbidity is observed that is mainly
characterised by keloids or hematoma. According to recent studies, this amounts to about
2.4% [107]. In animal experiments, there was no
difference in quality with the type of cartilage (rib vs. ear) or origin of the fascia
(autogenic vs. allogeneic). Minor differences were only observed in ossification and
calcification, but had no impact on the outcome [108].
9.1.7 Quality of subjective perception of the patients with costal and auricular
cartilage
Since the implementation of the “diced cartilage” technique, regardless of
the type, patient satisfaction and quality perception have significantly improved, because
deviation is now improbable. Moreover, the rigidity is no longer rated as disturbing by the
patients because the other forms are clearly softer in terms of their haptics [103]. As regards the harvesting morbidity, this certainly depends
on the surgeonʼs experience. Most recent investigations show that patients do not perceive any
difference between auricular or costal cartilage [109] and
this is reflected in the outcome quality.
10. Ultrasound-based vs. Conventional Osteotomy
10. Ultrasound-based vs. Conventional Osteotomy
In the course of recent decades, conventional osteotomy has been modified, especially by
switching from the closed to the open access. This technique was originally performed
endonasally with the Walter osteotome; external, lateral, transversal, and paramedian osteotomy
were then introduced, as first described by Goria in 1955 and published by Straatsma in 1961
[110]
[111].
Its clinical superiority with respect to swelling, bleeding, and mucosal damage were
demonstrated in several trials with continuous or perforating fracture line – in the
sense of a greenstick fracture – also in cadaver interventions [112]
[113]. Generally, these studies were focused on describing the
handling and short-term results but not the middle- and long-term improvement of the patientsʼ
postoperative quality of life.
Technical progress led to the implementation of other methods. In other disciplines, such as
dentistry, osteotomy with ultrasound was established long before being used in rhinosurgery.
Robiony et al. first described the application of piezo surgery in rhinosurgery in 2007 [114]. They now enjoy the longest experience worldwide, but only in
percutaneous use. Their 10-year follow-up, which was published in 2019, describes piezo
osteotomy with no or mild swelling in more than 90% of 183 patients. The further
development goes in the direction of piezo-navigated access, but has not been established yet
[115]. In contrast, Gerbault, Daniel et al. perform
ultrasound osteotomy via an enlarged open access with widely prepared soft tissue mantle [116]. In his retrospective study published in 2019, Berghaus came
to the conclusion that the piezo technique in rhinoplasty is a safe and precise procedure for
bone modelling and osteotomy [117].
In an animal model, Kurt Yazar et al. showed that - in contrast to percutaneous or endonasal
osteotomy - piezo techniques leads to fewer mucosal lesions and undesired fracture lines [118]. This corresponds to the reported experiences of regular
users of this osteotomy technique. Long-term results are currently not available for all
conducted trials. At least currently published data do not show any apparent disadvantage of
this technique, even if significant advantages could not be shown either. With regard to the
patientsʼ quality of life, there have been no investigations that would allow a comparison.
10.1 Quality of external and/or cosmetic results
In 2017, Kocak et al. reported a prospective trial of 49 patients. They found that swelling
on the first two postoperative days was significantly lower than with conventional osteotomy
[119]. However, this significance rapidly disappeared until
the seventh postoperative day at the latest. Since the reduced swelling is only described for
the first 48 hours in both piezo methods (open vs. percutaneous), this effect cannot be due to
the extent of soft tissue preparation. In cases of ecchymosis, piezo surgery is significantly
superior to conventional osteotomy in the complete follow-up interval. This could also be
confirmed in a systematic literature analysis performed by Währmann et al. in 2019
[120]. However, it remains unclear if the relatively minor
pains that were described were really alleviated or if this was only a consequence of the
patientsʼ impression of decreased ecchymosis. The authors correctly describe these results as a
trend, as they have not been verified statistically and long-term results are completely
missing in all areas.
10.2 Quality of the functional and/or endonasal results
Even after 10 years of follow-up, scientific papers on the functional and/or
endonasal results are not available. However, this would be desirable, in particular with
regard to the described minor mucosal lesions. No studies have been performed to compare
endonasal and percutaneous osteotomy, although external osteotomy is said to be superior with
respect to mucosal lesions.
10.3 Quality of the subjective perception of patients
No valid investigation has yet been conducted. Only the significantly reduced swelling in the
short postoperative interval (up to 2 days postoperatively) and the lower degree of ecchymosis
have been verified and described by the investigators (see above). With regard to the quality
of life or functional impairment, no valid data or trials are available, although this will
certainly be made good. However, Baumann et al. showed that there is no difference in the
subjective perception of the patients or the quality of life with respect to internal or
external osteotomy [85]. There is only one established
difference between different osteotomy techniques – the lesser pain reported by the
patients after piezo osteotomy.
11. Preservation vs. Traditional Rhinoplasty
11. Preservation vs. Traditional Rhinoplasty
There is a lively discussion on preservation rhinoplasty. This is not a new approach in the
field of rhinoplasty. In 1899, J.L. Goodale was the first to publish this technique in the
Boston Medical Surgical Journal under the title of “A new method for the operative
correction of exaggerated roman nose” for the area of the nasal dorsum [121]. Although even then the preservation of the keystone area was
postulated, this knowledge was lost over time, as often occurs in medicine, especially after
Joseph described reduction techniques with removal of the hump in the keystone area in 1931
[63].
The re-discovery of preservation shows that interest in the preservation of anatomical
structures has been revived. Since the publication of Sheenʼs book in 1978 (see above),
rhinoplasty has developed from resection to reshaping. Now the development seems to be from
reshaping to preservation of anatomical structures. This is possible mainly due to newly
acquired knowledge of the anatomy and physiology of the nose (see above), improved suture
techniques and refined surgical techniques.
The first results of so-called “push down preservation” rhinoplasty were
described by Barelli in 1975 [122]. Yves Saban re-discovered
this technique and evolved it for closed access [123]. This
technique now involves either complete preservation of all structures or partial preservation of
specific structures (skin/nasal dorsum, skin/nasal tip, nasal tip/nasal
dorsum). In 2018, Yves Saban et al. published a trial of 320 patients, in which they compared
the let-down technique (LDT) and the push-down technique (PDT) [86].
The basic difference is that PDT is indicated in cases of smaller humps of up to 4 mm, when
the fully mobilised nasal pyramid is “pushed down”. It has become clear that the
keystone area is the semimobile cartilaginous joint [69].
During LDT, the nasal pyramid is “let down” after an additional incision in the
area of the maxillary processes; this is indicated for humps over 4 mm. The same preservation
technique can be used for closed and open access. In 2019, Rollin Daniel published 100 cases
that underwent exclusively open surgery with a follow-up of one year [124]. He considered that this technique represented a new paradigm
shift that preserves the dorsal soft tissue mantle and the ligament structures of the nose
– especially in the area of the nasal tip (see above). However Saban and Daniel
emphasise that the patients have to be selected very carefully and that this technique cannot be
applied in all kinds of hump noses.
11.1 Quality of external and/or cosmetic results
All surgeons consistently describe an accelerated postoperative healing phase with lower
swelling tendency and that the external results are very satisfactory. A combination of
preservation and piezo technique is meanwhile in the testing and was published as a case report
by Göksel and Saban in 2019 [125].
11.2 Quality of functional and/or endonasal results
Corresponding results with short- or long-term observation are completely missing. This is
certainly on the agenda of future projects, in order to emphasise the relevance of preservation
on breathing quality too.
11.3 Quality of subjective perception of the patients
The patient statements reported by the surgeons have been positive. Unfortunately, the
corresponding PROMs have not been performed and only these can lead to verified results in the
assessment of a long-term analysis.
12. Patient Reported Outcomes (PROs)
12. Patient Reported Outcomes (PROs)
The parameters for clinical effectiveness are typically reflected in the outcomes that are
important for the patients, such as symptoms, function, optics, or morbidity.
It is fortunate that in recent decades the concept has been established that treatments need
not only be clinically effective and profitable, but also acceptable and indeed desirable for
the patients. Measurements of clinical efficacy cannot tell us anything about the patientsʼ
feelings, thoughts, or what they want to achieve with the treatment. Measuring this element of
acceptance requires patient-based evidence that includes the well-being regarding the treatment
and the outcome.
For this purpose, the focus is increasingly placed on the development of patient-reported
outcomes (PROs) that centre on the perception of a disease and its treatment by the patients.
Patient reported outcome measures (PROMs) are tools that are used to measure and assess data of
PROs and since 2011 they have given rise to many publications [126].
In general, for all PROMs two categories are differentiated. Firstly, there are the general
PROM instruments (e. g. SF-36, EQ-5D) that measure the general health-related quality of
life and may be applied independently of the disease. The results are comparable over different
patient and population groups. Secondly, there are disease-specific PROM tools (e. g.
ROE, FROI-17, Oxford Knee Score) that measure the severity of a specific disease or a certain
aspect of a disease or organ [127].
The specific survey possibly shows relevant details that would not have been assessed by
generic tools. Whether a generic or specific instrument is selected depends on the objective and
the question.
Patient reported outcomes are important because they provide the patientsʼ perspective of the
treatment and the outcomes that is not recorded by the clinic alone. However, it is just as
important for the patients as the scientific result.
Typically, the following dimensions are systematically assessed [128]:
In contrast to clinical standard results, PROs give a unique insight into which impact a
certain therapy or surgery may have on the patients, especially regarding the outcome after
rhinoplasty.
People with exactly the same health conditions, diagnoses, or sensitivities have different
perceptions, since every individual perceives different factors contributing to the satisfaction
with a specific result. PRO data are important because they reflect more exactly the real
benefit that is relevant for the patients.
The ability to measure well-being as result is greatly important in clinical situations where
the primary goal is the treatment of the patientsʼ well-being (e. g. rhinoplasty) and
not the prolongation of life expectancy. The use of PROMs before, during, and after treatment
shows changes in the individual patient level, e. g. improved physical functions, higher
quality of life [129].
PROs have to be defined thoroughly so that they assess the information that is relevant for
the patients. This information must be precisely measured and if possible in a way that makes
them comparable to other results. By implication, this means that it is relevant how a
question is formulated, when the questions are asked, how the answers are
assessed, and how the data are interpreted. This means, the more precisely and
specifically the question is formulated, the better is the detailed information from the
patientsʼ perspective. The definition of the PROs determines the measurement objective such as a
symptom, an effect, or an external characteristic etc. [130]
[131].
The most important concepts measured by means of PROs are:
The HRQoL is multidimensional and represents the patientʼs opinion of a disease and its
treatment in daily life, including the physical, mental, social function and emotion,
well-being, vitality, health status etc.
The rating of the outpatient or inpatient institution as well as single treatments, service
providers including all staff members of health-related professions etc.
Physical impairment and limitations at rest and during activities, including self-care and
other daily activities such as walking, mobility, sleep, sex etc.
Positive or negative emotions, cognitive thinking including anger, attention, self-esteem,
well-being, sorrow etc.
Reports about physical and mental symptoms or feelings that are not directly visible including
physical power and fatigue, nausea, irritability etc.
Impairment at work, in school, with friends and family interaction etc. as well as active
participation in social life.
Reports and observations about active postoperative compliance.
The usefulness or serviceability is the beneficial condition for the satisfaction of needs. In
health economy; the patientsʼ preference is measured on the basis of usefulness, e. g.
how important different factors are for the patients, such as symptoms, pain, and mental health.
In this way, the impact of new treatment methods on these factors and thus on the quality of
life can be investigated. It is a common approach to evaluate new therapy approaches as well as
to assess if treatments should be paid by the cost bearers.
A high quality PROM tool is valid, provides consistent and reproducible data on the effect of
the treatment and reacts to changes. In the selection of the PROM tool, it is important that the
characteristics of the group of people on which the evidence is based (age, gender, disease
etc.) is comparable with the group to be examined. For development, evaluation, implementation,
and reporting of PROMs, multiple manuals and publications are available. But this also means
that the changes in the quality of life are not always optimally reflected in PROMs because
often the trials do not have a cohort, are not prospective, and cover only a short follow-up
period [126]
[132]
[133]
[134].
12.1 Quality of the external and/or cosmetic results and the quality of
life
In the field of rhinoplasty, quality analyses mostly encompass a combination of inner and
outer outcome with focus on the postoperative function. The one exception in the
disease-specific area is the “Rhinoplasty Outcome Evaluation (ROE)”, which
focusses on the external appearance. The ROE was published in 2001 by Alsarraf et al. [135].
Currently, the ROE is the only disease-specific PROM focusing on the external result of
rhinoplasty. However, it must be mentioned that the questionnaire also has disadvantages, as it
only contains six questions and five of these are related to external appearance. This means
that the ROE has definite weaknesses in terms of sensitivity and specificity and does not
optimally meet the above-mentioned requirements of a disease-specific PROM.
Two retrospective publications found a mean improvement of 36.7 points in the ROE after five
[136] and after 36 months [137].
In one of the largest follow-up papers (60 months), Bulut and Baumann et al. confirmed that
the ROE after one and after five years showed significant postoperative improvement in the
outer appearance and quality of life [138]. This is the only
study that evaluated this long follow-up period for the field of septorhinoplasty. The data
reflect the finding that retrospective trials show similar results to prospective analyses, but
the validity of prospective trials is clearly greater than that of retrospective studies
(“response shift bias”, see below).
Among the PROMs, the FACE-Q has an intermediate position, as it is not focused on the nose
but on changes in the face and thus is also applied to eyelid surgery, face lifting etc. [139].
This makes sense because the nose is in the middle of the face and dominates everything else
in the patientsʼ perception. In the further development of the FACE-Q, a nose module is
presented that encompasses 19 questions. Ten of these are related to the nose, 4 questions
focus on adverse effects of surgery, and 5 on the nostrils. On this basis, the conclusion could
be drawn that the outward changes in the face had a significantly positive effect on all areas
(appearance, quality of life, mental well-being etc.) [140].
The general PROM entitled “Short-Form 36 Health Survey (SF-36)” that analyses
the general physical condition [141] reveals improvements one
year after surgery in the fields of role-specific effect and cognitive health. Five years after
surgery, significant improvements from the preoperative findings were found in the areas of
physical functioning, role-specific effect, cognitive health, bodily pain, vitality, and social
functioning. However, the SF-36 did not show significant changes between the 12th
and 60th postoperative months. This is striking, as an improvement was identified
compared to the preoperative status, which might lead to the conclusion that the SF-36 reaches
its limits for postoperative assessment. A correlation between SF-36 and ROE could not be found
for all evaluated periods ([Fig. 3]). This might be due
to the very unspecific questions and the low number of questions of ROE; this also reveals its
weakness as a disease-specific PROM (see above).
Fig. 3 Preoperative assessment by means of ROE, FROI-17, and SF-36 compared to one and
five years after surgery, also comparison between one and five years after surgery.
©: Bulut OC, Wallner F, Oladokun D et al. Long-term quality of life changes after
primary septorhinoplasty. Quality of life research : an international journal of quality of
life aspects of treatment, care and rehabilitation 2018; 27: 987-991.
12.2 Quality of the functional and/or endonasal outcome and quality of
life
Two PROMs play a major role in the function after rhinoplasty: NOSE and FROI-17. NOSE (Nasal
Obstruction Symptom Evaluation) was established in 2004 by Stewart et al.. It primarily
illustrates the functional and obstructive aspect and confirmed improvement in the quality of
life after surgical treatment of obstructed nasal breathing [142].
Another PROM was presented in 2018 that has a strong correlation to NOSE but does not have
the same impact in the cosmetic area. SCHNOS is mentioned here for the sake of completeness. As
it has only recently become available, further data are needed for evaluation. The
questionnaire includes four questions on breathing, five on the shape of the nose, and one
question on the patientsʼ self-esteem [143].
FROI-17 was initiated and established by Baumann et al. in 2014 [144]. It is intended to be a general assessment, as it also takes into account optical
and functional data. The analysis of functional results revealed a significant change in the
patientsʼ perception of nasal function 12 and 60 months postoperatively [138]. Furthermore, the authors confirmed that patients with a
preoperative crooked nose were significantly more satisfied after surgery than patients with a
straight preoperative nose. In addition, a correlation between the general PROM SF-36 and the
disease-specific PROM FROI-17, in contrast to ROE, was found (see [Fig. 3]) [85].
These data of the FROI-17 trials of the inner and outer nose are clearly important, as this
is a prospective trial and therefore has less risk of bias than a conventional retrospective
study, which incorporates a retrospective assessment of the preoperative situation (response
shift bias).
The overall conclusion is that - from the patientsʼ perspective – these is a
significant long term improvement in quality of life, with respect to both the internal and
external nose.
12.3 Quality of the subjective patient perception of PROM in rhinoplasty
First, as for all cosmetic treatments, the patientsʼ perception of their own bodies has to be
taken into consideration. An improvement in mental health after cosmetic interventions was
already demonstrated in the mid1990s [145]. The most
frequently observed mental disease that is seen in plastic surgery is body dysmorphic disorder.
Recent meta-analyses showed that a mean of 15% of all patients wishing external changes
suffer from body dysmorphic disorder. This would be more than one patient of six. In
rhinoplasty, this amount is even higher - 21–48%.
Of course, this aspect is also reflected in the results and the interpretation of PROMs [146]. Picavet et al. confirmed a clear correlation between
disturbed body perception and the wish for rhinoplasty [147].
In addition, Felix et al. showed that patients with body dysmorphic disorder benefit from
rhinoplasty, but that they have significantly poorer scores pre- and postoperatively compared
to the control group without this mental disorder [148].
Furthermore, the evaluation of all questionnaire tools has to take into account that most
rhinological patients are female, young, and healthy usually without having other health
problems. Therefore the improvement in physical findings has a more direct impact on all areas
of life. In a demographic analysis, Schwitzer et al. reported that the satisfaction about an
improvement in external appearance and quality of life depends on age, gender, race, and
income. White, female patients younger than 35 years were clearly more satisfied with their
postoperative quality of life and their external appearance than all other groups [44].
In addition, the timeline of the follow-up is a relevant aspect in the analysis of the PROMs.
The positive change in bodily and mental perception and the quality of life is especially
obvious in the first 12 months after surgery [149]. A
meta-analysis performed by Yang et al. in 2018 verified this in a review of all rhino-specific
PROMs and confirmed the improved quality of life, in particular in the first 12 months and in
young patients [150].
In a more restricted prospective study, Sarver et al. confirmed that the positive change
after cosmetic surgeries in general (nose, eyelid, breast etc.) primarily takes place in the
first 3 months, independently of the patient population [151]. As yet, no improvement in the quality of life has been demonstrated after 60
months [152].
On one hand, the functional and optical improvements are positively reflected in the
questionnaires (SF-36, FROI-17, and ROE), especially in shorter follow-up periods of one year.
However, the functional improvements on re-socialisation, self-confidence, and self-esteem
clearly appear later, as reflected in the long-term data of the FROI-17. This is in contrast to
the ROE - that failed to confirm any positive long-term improvement. This is consistent with
the findings of Bulut et al. that the type of procedure does not affect the quality of life or
bodily perception in any way. This is particularly interesting, as two thirds of their patients
underwent closed and one third open surgery, which is contrary to the current general trend
[153].
13. Conclusion
-
The quality of cosmetic plastic rhinoplasty depends on many different factors.
-
As in all types of surgery, rhinoplasty is influenced by institutions, cost bearers,
patients, and media (primarily internet and social media).
-
Measurable and tangible quality is defined and expected in different ways by the single
groups.
-
Cost-effectiveness and quality do not exclude each other but they are definitely not
mutually dependent.
-
As regards changes in external appearance, the quality of rhinoplasty often depends on soft
factors and the cosmetic taste of the patients.
-
According to current knowledge, the quality of rhinoplasty does not depend on the type of
access, technique of osteotomy, or other single steps but on the outer and functional outcome,
as reflected in general and disease-specific PROMs.
-
The quality of the outcome is more important than the quality of the procedure.
-
Quality assurance and quality confirmation for all areas and institutions can only be
established by means of scientific evaluation of the studies. This will encourage the use of
guidelines and evidence-based data.
-
The objective should be the serious implementation of prospective comparative studies as is
usual in drug or cancer therapy. This would enhance the surgeonʼs position in relation to cost
bearers and decrease dependency on the influences of industry.
