Examples of Health Services Research and Health Economics in the German Healthcare
System From the Perspective of Gynaecology and Obstetrics
Care with consideration of staffing resources and ongoing training
Adequate education, advanced training and ongoing training are essential for safeguarding
future clinical competence [6] and are based on the following definitions: education means the dissemination of
skills and knowledge required to carry out the profession, i.e. study. Advanced training
is taken to mean the expansion and renewal of knowledge, skills and abilities following
the initial training phase, i.e. further specialist training. Ongoing training means
the furthering of qualifications in occupations that require continuing training,
for instance after reaching the consultant level [7]. The concern is that dwindling economic resources in hospitals, along with the dissatisfaction
amongst clinicians with these working conditions, are leading to cutbacks in clinical
education, advanced and ongoing training – with the resulting lack of qualified specialists.
The flood of doctors at the end of the last millennium
changed directly at the start of the new millennium into a shortage. The reasons cited
for this include increasing numbers of graduates going abroad and entering other professions.
At the moment, the number of places available for advanced clinical training is frustrated
by a shortage of interns seeking advanced training [8]. There is no shortage of advanced training places, but only a small number of doctors
and specialists are interested in these.
Education, advanced training and ongoing training therefore need to be made more appealing.
These are based essentially on the parameters which also depend on adequate financing:
a good working environment, good, supervised dissemination of advanced training content,
and adequate remuneration.
By contrast, Germany has numerous problems, forcing specialists to increasingly focus
on this issue in the context of health service research. One example is the new working
time directive, which has led to a shortage of doctors on day shifts and therefore
to a shortening by 250 days of the actual time spent on day shifts across the entire
advanced training phase [7]. As a result, the opportunities to acquire skills in a practical setting have considerably
diminished. The operational catalogue of advanced training has also shrunk, lowering
the demand for practical qualifications. The increasing administrative duties – one
third of the time spent at work is spent at a desk – considerably hampers advanced
training. Ongoing training courses, which cannot replace clinical experience and therefore,
according to the definition set out above, cannot replace advanced training, are also
being called into question [7].
Advanced training must also needs be affordable in the future. A study in Switzerland
from 2002 calculated the costs of training specialists at around 60 000 Swiss Francs
per intern and year [9]. This correlates with other data, according to which a five-year advanced training
course costs 300 000 Swiss Francs (around € 240 000) per individual [10]. As clinical advanced training in Switzerland is comparable with that in Germany,
this can be taken as a guideline for further training costs in Germany. An examination
of the distribution of advanced training in hospitals reveals a rather uneven picture.
All hospitals receive the same diagnostic-related case (DRG) per-case flat rates.
Consequently, hospitals without advanced training and therefore without the associated
costs must be labelled as over-financed, while hospitals which offer increased advance
training are under-financed and therefore at a competitive
disadvantage [6].
There are many possible solutions. The German Association of Gynaecology and Obstetrics
(DGGG e. V.) has already begun restructuring its advanced and ongoing training. Advanced
training courses will now include practical modules in which participants will learn
not only techniques, but also the entire spectrum of knowledge from indication to
aftercare and follow-up.
In the context of limited staffing resources in hospitals, improved teaching may also
be assisted by new concepts, such as the integration of structured practical teaching
(skills training) based on suitable obstetric and gynaecological models delivered
by specially-trained student trainers (peer teachers) [11]. Verification of the skills learned can be as a formative theory/practical examination
(“mini-OSCE”). This type of concept, however, needs to be supported and evaluated
in the context of health services research. Frobenius et al. [12] compared skills training with classical training from lecturers in an experiment
involving 139 students. After examination of the learned content, it was found that
teaching by specially-trained student peers is just as effective for communicating
the principles of fundamental practical skills as teaching by lecturers – with the
bonus of reduced clinical staffing costs. This
is certainly applicable to clinical advanced training also. In a prospective study,
for example, a three-month laparoscopy training course was evaluated on the basis
of four training models [13]. An evaluation of the exercises carried out was performed before the study commenced
and after the training phase. The uni-variant and multi-variant analysis showed that
a structured laparoscopy training course can achieve a learning success using models
independently of the level of training and surgical experience and would be a useful
tool in clinical training.
In relation to ongoing training also, after completion of training to become a specialist,
there are concepts whose content has been evaluated in comparison with international
concepts. One example of note at this juncture is the established curriculum for the
training of certified breast surgeons of the German Working Group for Aesthetic, Plastic
and Restorative Operational Procedures in Gynaecology (AWO-gyn) [14]. This encompasses not only the mastery of operating techniques, but also a comprehensive
knowledge of the interdisciplinary treatment of patients with breast cancer. It also
needs to be borne in mind that increasing operative specialisation is associated with
the outcome [15], [16], [17]. Skinner et al. [16] compared the results of oncological and general surgeons based on a group of 29 666
patients with breast cancer, for
example. In this case, specialisation and treatment by an oncological surgeon showed
a 23 % higher overall survival rate (RR 0.77 [95 % 0.67–0.88]; p < 0.0001). This leads
indirectly to the conclusion that an evaluated curriculum for specialisation represents
a cost-effective measure from the perspective of the healthcare economy as well in
terms of the improvement of the quality of the outcome and the reduction of follow-on
costs due to avoided recurrences/metastases [15].
A further urgent problem in advanced clinical training is the distribution by gender.
While the number of female students is constantly rising – over 60 % in the 2009/2010
winter semester – the number is falling in the higher echelons of universities and
hospitals [18]. Only eight per cent of consultantsʼ positions are held by women, and in surgical
disciplines this figure is even lower. This problem is particularly acute in relation
to gynaecology. In this discipline, women take 77 % of all university advanced training
places, but hold only 34 % of managerial positions or 4 % of the consultantsʼ positions
[18]. In a survey carried out by the DGGG involving 1037 responses, the cause was revealed
to be the lack of scope for harmonising family and work life (e.g. due to lack of
child care). Consequently, the majority of female clinicians prefer to work in general
practice [18]. The problem
for the future can be predicted accordingly; if more and more women are working in
gynaecology, but are not holding the senior cliniciansʼ roles in hospitals, there
will be a lack of experienced surgeons and sufficiently comprehensive care will be
at risk.
The fact is that education, advanced training and ongoing training in our discipline
needs to be improved and stepped up, as we shall otherwise be faced with a huge lack
of specialists – both in terms of numbers and in terms of quality. Besides the campaigning
of the professional association for better funding new, resource-saving concepts for
communicating knowledge and skills need to be developed and evaluated in the context
of health services research.
Oncological care and quality assurance
In the field of oncological care and quality assurance much has changed in recent
years. These changes, such as care in certified structures, an expansion of quality
assurance measures, the development of guidelines, etc. will continue to make great
strides in the immediate future.
Below, these changes will be explained using the example of patients with breast cancer
to show which changes are transferrable to the structures of other organ entities.
Although the incidence of breast cancer has risen significantly in the last few decades
and continues to do so, mortality rates have fallen. This can only be convincinly
presented, however, if data from clinical and epidemiological cancer registers are
made available and sufficient levels of follow-up are possible, as patients can be
lost to follow-up, especially those in remission, and therefore this may indicate
a poorer quality of treatment and not in fact reflect reality [19]. Consequently, causes for these developments can be analysed and positive influencing
factors stepped up – this is a significant, if not in fact the most important, aspect
of health services research.
Data from the German cancer register, the Robert Koch Institute and the German Statistics
Office indicate that the incidence of breast cancer has risen by 50 % between 1980
and 2004 [20]. According to the latest estimate, the annual number of women developing the disease
in the last 10 years has risen from 50 000 in 1995 to 57 000 in 2004 ([Fig. 4]). The use of hormone replacement therapy in recent years and improved early detection
are regarded as possible reasons for the upward trend. By contrast, mortality has
fallen over the last decade by 15 %. The five-year survival rate rose from 73 % in
1998–1992 to 80 % with the initial diagnosis in 1998–2002, presumably due to the earlier
detection of tumours while still small and primarily due to improved adjuvant therapy
[21]. Further progress is expected by the establishment of certified organ cancer centres
[22], [23], [24], the implementation and consistent use of guidelines [25], the use of targeted therapies [26], early detection via mammography with suitable quality assurance [27] and the identification of new and prognostic markers [28]. This will only be measurable, however, if the implementation of these new structures
and innovations is accompanied by health services research-related projects. In a
retrospective cohort study involving a total of 3976 patients with a primary breast
carcinoma diagnosed between 2001 and 2005, Wöckel et al. showed that only 2063 patients
had been treated completely in accordance with guidelines [25]. The variable “guideline-compliant treatment” had a significant influence on recurrence-free
survival and overall survival (p = 0.001)
([Fig. 5]). As the number of deviations from the guidelines rose, the overall survival rate
fell (p = 0.0001). Guideline-compliant treatment, however, also requires compliance
on the part of the patient. The patient needs to play her part in every recommended
treatment option. Consequently, the adequate communication of information and shared
decision-making are essential. A health services study by the University of Cologne
involving 3733 patients from 51 breast cancer centres also showed that, for the most
part, this functions well from the patientsʼ perspective, but that there is potential
for improvement in terms of information going beyond medical treatment, as well as
the active inclusion of patients in the treatment process by the physicians treating
them [29]. Patients are also the most important factor when it comes to establishing certified
centres. An awareness of the role – as well as the presence
– of a certified centre is a key requirement for their implementation. This can be
evaluated through health services research. In a study involving 1073 patients, no
fewer than 78.2 % of the patients at a breast centre were familiar with the definition
of a certified centre [22]. Compared to obstetric patients, receiving treatment in a specialist centre was
seven times more important for oncology patients – a highly significant figure.
Fig. 4 Incidence of and mortality from breast cancer, trend from 1980 to 2004, number of
diagnoses and deaths in 2004 [20].
Fig. 5 a and b Kaplan-Meier curves on a recurrence-free and b overall survival for guideline-compliant vs. non-compliant treatment, adjusted for
tumour size, node status, grading and age [25].
A further reduction in mortality, as well as optimisation of the care of oncology
patients, can be expected from the introduction of the National Cancer Plan ([Fig. 6]) [6], [30], [31], [32]. The underlying reason for the National Cancer Plan, initiated by the German Ministry
of Health, German Cancer Society (Deutsche Krebsgesellschaft e. V. [DKG]), German
Cancer Aid (Deutsche Krebshilfe e. V. [DKH]) and the Working Group of German Tumour
Centres (Arbeitsgemeinschaft Deutscher Tumorzentren e. V. [ADT]), is the ongoing high
number of new diagnoses of and deaths from cancer in Germany. In view of the high
incidence of breast cancer, this subject plays a key role in shaping the care of women
with cancer and therefore the National Cancer Plan. Areas of focus in this context
include the further development of oncology care in certified
structures, along with a clear definition of these ([Fig. 7]) and guideline-compliant therapy. The objective here is to define organ-specific
(such as the breast or ovary) but also multi-organ (such as psycho-oncology, supportive
measures, palliative medicine and pain management) approaches in order to implement
transparent standards of care and also to further develop existing guidelines. An
informative oncology quality reporting system is also being promoted for service providers,
decision makers and patients, with particular support for clinical cancer registers.
Adequate documentation systems will ensure a high quality of documentation and data,
which on the one hand will relieve the pressure on certified organ cancer centres
which expend considerable staffing resources to achieve the figures required in the
survey sheets and which, on the other hand, will comprehensively stratify the progress
of the disease not only in terms of
mortality, but also in terms of such parameters as recurrence and metastatic disease.
Proving the benefit of certified structures based on outcome quality will enable a
determination of the cost effectiveness of these structures and funding then requested
on the basis of adequate data. Until now there has been no definitive evidence that
a certified breast centre is able to achieve a better outcome quality independently
of other influencing factors or propose an independent parameter for the prognosis
of breast cancer. It is here that health services research can help. Recently, the
highly significant proof of mortality figures in relation to an improvement in mortality
figures was published in Middle Franconia [33]. The data from 3940 patients with breast cancer from three certified centres and
18 further non-certified treatment units was examined with the help of the Erlangen-Nuremberg
Tumour Centre to determine whether care in a
certified breast centre offers a better survival prognosis. The data showed that patients
treated in a certified breast centre had a 30 % better overall survival rate after
four years – regardless of the tumour characteristics or other patient characteristics,
such as age.
Fig. 6 National Cancer Plan [32].
Fig. 7 Definition of cancer centres [32].
Aftercare is an important topic, not least in relation to oncology care. The optimisation
of aftercare, in particular compliance with participation in recommended investigatory
procedures, remains a challenge [34]. Health services research can also help here [28]. A Canadian study randomised patients with breast cancer to routine aftercare or
an intensive programme comprising a half-hour educational session, a patientʼs version
of the aftercare recommendations, brochures and information on how to obtain further
support [35]. In the control group, higher QALYs were achieved (1.42 vs. 1.41); this was also
achieved with reduced costs compared to the intervention arm. The probability of cost
effectiveness of the intervention arm was 27 % in the case of $ 50 000 per QALY. This
means that the more intensive system was definitely not cost effective and therefore
cannot be recommended. These
data emphasise the need for health economics evaluations for the case of more intensive
support programmes, as not every approach is necessarily effective.
Drug therapy
Drug therapies in particular are associated with enormous costs and are therefore
ideal for health economics evaluations. The costs of drugs rose, for example, from
€ 19.2 billion in 1999 to € 32.4 billion in 2009. The financial pressure is also underscored
by the new law on the restructuring of the medicines market (AMNOG) [36]. Oncology preparations, such as anti-hormone treatments, chemotherapies, targeted
therapies and supportive medications, account for a significant part of these costs.
For these, there are usually numerous study outcomes serving as the basis for guidelines
and recommendations [37], [38], [39]. Rarely, however, are these integrated into health services research and health
economics, although this could be of considerable benefit [40]. As an example, we mention drug therapy for patients with breast cancer.
One key element of health economics considerations concerns the endocrine therapies
employed in adjuvant therapy for patients with hormone receptor-positive breast cancer
[40]. The age-standardised incidence of breast cancer has risen since the 1980s by around
50 % [41]. Current calculations indicate a five-year prevalence of 249 600 women. The five-year
prevalence of all women with breast cancer over the age of 50, i.e. generally post-menopausal
women, is 193 000 women [41]. Assuming that 71.5 % of these are hormone receptor-positive [42], treatment with aromatase inhibitors will potentially affect 137 995 women in Germany.
This corresponds to nearly half a per cent of the female population over the age of
20. In view of the high proportion of women and taking account of the long duration
of endocrine therapy (at least five years and including extended
adjuvants up to 10 years), it is perfectly understandable that the benefits of endocrine
therapy need to be weighed against the risks and costs from the perspective of the
healthcare system [43]. The benefits of aromatase inhibitor therapy are well documented and are also supported
by current publications, such as the effectiveness of letrozole in accordance with
the results of the BIG 1-98 study [44]. Health economics is useful for weighing advantages and costs, including quality
of life, in the equation. In 2007 the Health Technology Assessment (HTA) programme
published a meta-analysis of the available economic analyses of the aromatase inhibitors
letrozole, anastrozole and exemestane compared with tamoxifen. The HTA, which is part
of the National Institute for Health Research (NIHR), provides the data in support
of decisions made by NICE. The cost effectiveness of aromatase inhibitors was between
£ 21 000 and
£ 32 000 per QALY for up-front therapy, £ 10 000 for extended adjuvant therapy with
letrozole, and £ 20 000 for switch or sequential therapy. Aromatase inhibitors were
consequently evaluated as cost-effective therapy. This is also reflected in the prescribing
behaviour in Germany. In a survey from 2009 involving 74 clinicians whose organisations
treated a total of 31 000 breast cancer patients a year, the proportion of post-menopausal
women receiving adjuvant therapy with an aromatase inhibitor at the time of the survey
was 74 % [46]. In this case, up-front therapy was the first choice, followed by sequential therapy
(40 %). Regional differences were only slight. A further German health services research
analysis investigated the incidence of adverse gynaecological and surgical interventions
in treatment with anastrozole, compared with tamoxifen [47], [48]. A significantly higher
incidence of gynaecological events was found with tamoxifen (34.2 vs. 20.5 %, p < 0.0001).
This resulted in an increase in diagnostic and surgical procedures and a four-fold
increase in hysterectomies with tamoxifen (p < 0.0001) and thus underscores the cost-effectiveness
of aromatase inhibitors.
Endocrine therapies are only as good as the manner in which they are used. As a result,
investigating compliance with drug therapies is an important element of health services
research. Non-adherence, i.e. the consumption of less than 80 % of the planned dose,
and non-persistence, i.e. the premature discontinuation of endocrine therapy as a
result of poor compliance, lead to a significant reduction in the overall survival
rate (HR = 1.26 vs. HR = 1.49) [49]. Only 40–60 % of patients complete endocrine therapy as planned. Predictors for
the discontinuation of endocrine therapy include a younger (< 50 years) and older
(≥ 75 years) stage of life, breast-conserving treatment (vs. mastectomy), the prescription
of smaller package sizes, a higher contribution (especially among older patients)
and the existence of co-morbidities (≥ 2). During follow-up therapy, a detailed investigation
of the issue of compliance with endocrine therapies is
required, bearing in mind the predictors described above, while possible reasons for
early discontinuation, e.g. side effects, need to be discussed [34]. Compliance also needs to be improved by prescribing larger package sizes as well
as a reduction in contributions from patients with chronic diseases through cost bearers
which, given the possible economic damage caused by follow-on costs, are marginal
for the company involved.
One major deficit for health economics analyses is the lack of data in respect of
costs in metastasis situations, which can generally only be estimated. Chastek et
al. [50] investigated the costs of post-menopausal women with a hormone receptor-positive
breast cancer who had metastases. Using a retrospective health economics analysis,
1202 women were identified with a median age of 58.9 years. Before commencing chemotherapy,
the mean costs were $ 79 139 ± $ 121 489 per year (year 1: $ 54 725, year 2: $ 73 107
and year 3: $ 84 200). After chemotherapy was initiated, the mean costs were $ 132 786
± $ 117 635 (year 1: $ 92 639, year 2: $ 148 228 and year 3: $ 176 163). The highest
costs occurred in the outpatient sector. It is clear that endocrine therapies must
be given priority as long as possible and wherever available – not just in light of
the quality of life they bring, but also in view of their relevance to the health
economy.
A significant rise in costs is also seen with the increasing use of targeted therapies.
The focus is on the treatment of Her2/neu-positive tumours. The development of targeted
therapies for patients with a triple-negative breast cancer is also of scientific
interest [26]. An interesting meta-analysis of 75 pharmaco-economic studies of targeted therapies
(e.g. monoclonal antibodies and tyrosine kinase inhibitors) has been published on
this subject [51]. The studies, which were financed by pharmaceutical companies, showed a significantly
more frequent cost-effective result (87 vs. 48 %, p = 0.001). Even the alleged conflicts
of interests of the authors were associated with a positive outcome (78 vs. 43 %,
p = 0.007). As with all types of studies, it is necessary to examine the funding of
the project, even in the case of health economics studies.
Whereas modern supportive therapies may in some cases be associated with high costs,
the prevention of side effects, along with their associated cost-intensive management,
can save resources. The personalisation of supportive therapy, for example anti-emetics,
may also increase its cost effectiveness,. In a German study, 66 patients undergoing
a total of 190 cycles of chemotherapy were given anti-emetic therapy adapted to the
cytostatic drugsʼ emetogenic potential or therapy based on an algorithm taking account
of individual risk factors (such as age, gender, history of hyperemesis gravidarum,
etc.) [52]. The personalised algorithm demonstrated a significant advantage in relation to
complete freedom from nausea (76 % vs. 55 %, p = 0.035). A cost saving of 78.8 % was
also achieved, emphasising the significant potential of health service research.
Surgical treatment
Health services research and health economics evaluations focus on structural issues
or drug therapies which are mostly, by their very nature, very cost-intensive. This
is also apparent from the new law on prescribing drugs (AMNOG), which particularly
deals with the approval of drug therapies [36]. Research into surgical treatment tends to be neglected. This is regrettable, as
major surgical procedures require the provision of high levels of personnel and material
resources and enormous potential exists for optimising cost effectiveness. Internationally,
interesting work is being carried out in this field. In a multi-centre, randomised
study involving 21 Dutch hospitals, laparoscopic hysterectomy (TLH) was compared with
open abdominal hysterectomy (TAH) in relation to complication rates and the associated
costs in 283 patients with endometrial adenocarcinoma of the uterus (stage I) or complex
atypical hyperplasia [53]. The TLH had a lower complication rate (2.7 %) than the TAH (4.3 %), which other
studies also confirm [54]. The costs of a TLH were € 3453 and the costs of a TAH € 3577. The authors calculated
a cost saving of € 3700 per additional complication-free patient when a TLH is carried
out instead of a TAH. On this basis, they concluded that the TLH was a safe and, in
particular, cost-effective option for patients with early-stage endometrial carcinoma
from the perspective of the healthcare industry.
Health economics studies are also available from Germany. Schem et al., for example,
investigated whether the G-DRG revenues for vaginal, abdominal and laparoscopic hysterectomy
(HE) are sufficient to cover costs [55]. In this case, not only were personnel and material costs taken into account, but
the services of other institutions were also documented and included into the calculation.
79 hysterectomies, performed from 2005 to 2007, were taken into consideration. The
staffing costs alone accounted for one third of the total costs. In the evaluation,
the vaginal approach offered the highest level of cost effectiveness from the DRG
systemʼs perspective. Although the inpatient stay was shorter for laparoscopic operations
(5.33 days vs. 7.47 days for vaginal hysterectomy and 8.59 days for abdominal hysterectomy),
this was compensated by the higher costs associated with the longer operation. Added
to this are the costs of procedure-specific,
specialist endoscopic instruments (e.g. manipulators and morcellators) and case-related
accessories. In this case “high-tech” and “high-cost” are both to the benefit of the
patient [56]. From an ethical perspective, laparoscopy is associated with the least physical
trauma, the lowest level of analgesia consumption and the shorter inpatient stay and
can therefore not be rejected [54], [57], [58]. The results of the health services research underscore the need for more adequate
and more appropriate remuneration and a fair representation of minimally-invasive
procedures. If one raises the question of fairness in the DRG system from the point
of view of the extent to which the higher outlay for more patient-friendly (since
they are minimally invasive) procedures is covered, the problem only really becomes
apparent when one compares the reimbursement price for a
hysterectomy (N21Z) of € 3380.57 with that of an organ-preserving myoma nucleation
procedure, which is frequently more surgically intensive, of € 2992.44. At least it
must be established that the DRG system does not a priori encourage organ-preserving
procedures [56].
As the length of the inpatient stay following surgical treatment for patients with
breast cancer is continuously decreasing, more patients are treated as outpatients
and major, radical surgical procedures are increasingly tending towards breast-conserving
therapies with sentinel node biopsies. The question of costs therefore also becomes
relevant in the treatment of patients with breast cancer. Possibilities have to be
developed for achieving cost coverage or an actual earning situation while delivering
the best possible care. Process management and interface optimisation are key concepts
in this field which are being applied in the context of interdisciplinary clinical
treatment pathways. Even given the often pessimistic attitude of practising clinicians
towards quality management, proof of their effectiveness needs to be provided. The
interdisciplinary breast care centre at the Charité Hospital in Berlin has examined
this issue and, by implementing a treatment
pathway, achieved a reduction in overall case costs of 23.4 % [59].
In order to allow further cost effectiveness analyses of surgical techniques which
are essential both in terms of financial viability and in terms of allowing a comparison
of different methods to be carried out, as elaborated above consideration will also
need to be given in future to investigating the associated quality of life. These
go without saying in clinical studies on drug treatments and are required to calculate
quality-adjusted years of life, for example. Unfortunately there are only a few isolated
studies available on this issue [60].
Therapy in reproductive medicine
Therapy in reproductive medicine is particularly affected by the financial aspects
of healthcare. With the law on the modernisation of legal health insurance (GKV-Modernisierungsgesetz
– GMG), the regulations that applied until then to artificial insemination were changed
to the clear disadvantage of couples wanting children [61]. As well as a limit to a maximum of three cycles of treatment and the definition
of a lower as well as an upper age limit of eligibility for in vitro fertilisation
paid for by the health insurance scheme, lawmakers have also decreed that couples
must bear 50 % of the cost of the treatment themselves. Compared with 2002, during
which 87 044 cycles of treatment were carried out, this number rose in 2003 with the
announcement of the forthcoming revision of the legal framework to 105 854 (“anticipatory
effect”), falling to 59 448 in the year in which the GMG came into force, as confirmed
by the data from the German IVF
register [62]. These changes to the care of couples wanting children, with their dwindling case
numbers, will have far-reaching consequences for our profession. In the 1960s and
70s, Germany played a leading role internationally in gynaecological endocrinology
[63]. Currently, however, the specialised study of endocrinology, reproductive medicine
and andrology at universities is dropping, as these disciplines are unable to offer
job security and prospects for the future. Thanks to increasing survival rates for
oncological diseases and continual advances in reproductive medicine over recent years,
however, the field of fertility protection in cancer offers a wide variety of opportunities
for dedicated scientists with the establishment of new techniques enabling patients
who have undergone cancer therapy and, in some cases, aggressive surgical interventions
and even ovary-toxic malignancy therapy, to realise their
wish to have children. Examples of this include the establishment of trachelectomy
in patients with early cervical cancer, as well as the introduction of ovarian cryo-conservation.
Both methods were inconceivable years ago and in under appropriate circumstances represented
an oncologically arguable breakthrough in reproductive medicine offering the opportunity
to initiate a pregnancy after the conclusion of primary therapy. Such examples of
success are closely linked to university-based structures, as these are the only institutions
having an infrastructure suitable for the development and practical implementation
of theoretical hypotheses. Close cooperation between various disciplines, in particular
the close collaboration between oncology and reproductive medicine concerning the
nature and time window until commencing cancer treatment, on the one hand, and the
feasibility of various fertility-protecting measures, on the other hand, are essential.
And not least,
the needs of the patients affected are ultimately the deciding factor for determining
the type of treatment they receive. As fertility protection measures such as the cryo-conservation
of oocytes or ovarian tissue are generally not covered by health insurance schemes,
a decision also needs to be made on the financial burdens associated with these procedures
[64]. However, the first pregnancy in Germany following successful ovarian re-transplantation,
which was performed in the Gynaecology Department of the University Hospital of Erlangen,
has shown that focused, consistent work can be rewarded. The spectrum of fertility-protecting
measures continues to grow, and the indications encompass an ever-broadening area
of oncology. Disciplines such as internal medicine, paediatrics and surgery have long
since had to consider these issues also, as they are increasingly faced with the same
questions.
The provision of fertility-protecting measures for young patients is currently not
part of the certification criteria for organ cancer centres. As the bundling of expertise
from various focal areas increases in oncology centres and the achievement of corresponding
case numbers furnishes proof of the efficacy of individual procedures, figures will
emerge which may also reflect the discipline of fertility protection in a certified
centre. However, not every centre will be able to maintain this type of infrastructure.
On the one hand, health services research can open up new pathways by developing cooperation
models. On the other hand, this type of service requires commensurate counter-funding,
which may not be passed on to the patient. The wishes of young couples also need to
be borne in mind on our way towards comprehensive care in a certified centre.
Given the continuous decrease in the number of university-based reproductive medicine
centres, Germany is at risk of being downgraded to the status of a “scientifically
developing country” in this field. Legal obligations restricting the activities of
scientists in this field in Germany also mean that research is virtually impossible
and appears unappealing, since the legal framework in Germany is highly unlikely to
create competitive conditions on the international market for high-ranking, scientific
publications.
Added to this is the fact that 75 % of reproductive medicine patients are now treated
in general practices, while networking concepts between universities and practices
are generally lacking. As well as research, advanced and ongoing training are in great
jeopardy. Consequently, a clear definition of goals in health services research needs
to be developed along with suitable concepts for networking and cooperation. These
must then be implemented and evaluated on the basis of the extent to which the duty
of care is met, but also on the basis of research opportunities. Reproductive medicine
is also currently facing numerous ethical questions (pre-implantation screening, single
embryo transfer, heterologous insemination, oocyte donation) [65]. Only health services research can pursue these questions and answer them expediently.
Pursuing this point further, health economics can also be of great benefit. If one
examines the cost-effectiveness of reproductive medicine, it is reasonable to call
for financial support for couples wanting children. Solely from the perspective of
health economics, artificial insemination is arguably the most cost-effective medical
treatment available. Based on the transparent costs for artificial insemination, each
child represents an increase of at least 60 quality-adjusted life years and, in view
of the childʼs subsequent working potential, represents a considerable contribution
to the gross social product.
