Type of article: Editorial
Chairperson
of health science section at Medical Technologies Journal.
Advances in medical care are to a large
extent brought forward by new medical technologies. Their implementation into
daily medical routine requires a careful handling to be of rational use for individual
patients and to avoid harm as well. For this responsible task critical key
questions are listed for the deciding medical doctor treating an individual
patient, for a conclusive scientific evaluation and
as a decision support for insurers and policy makers to assess the economic
potentials and regulatory challenges of new medical technologies and
innovations.
Keywords: New Medical Technologies, Key Questions,
Evidence Based Medicine, Health Care, Contracts.
1. Introduction
Progress in medical treatment is basically driven by the human genius to
search for, invent, and recommend new medical technologies after examining pros
and cons exhaustively. However, the decision to apply non-contractual medical
technologies is often based on high hopes, core beliefs or principles and / or
commercial interests. Therefore caution and a critical reluctance are advisable
before the medical doctor is confident that his patients will actually benefit
from the new approaches to the treatment. Scientific institutions should have
found positively evaluated results based on the respective state of the art of
medical findings and insurances should provide a comprehensive and nationwide
financing for their insured persons contractually guaranteed.
2. The following Key Questions
are recommended for
·
The medical
doctor treating an
individual patient (1,2):
In case of an insured person: Is the designated
treatment required by the contract or is it non-contractual?
Is there a therapeutic consequence for the
individual when applying the new diagnostic method?
Is the relevant diagnosis certain and are
the diagnostic prospects exhausted? If not, further diagnostic investigations
are necessary.
Are there no other methods contractually
guaranteed to reach the aims of treatment with similar prospects of success?
Is there an adequate probability to induce
a positive effect on the course of disease at the least?
Is the evaluation of risks of the new
method compared to its advantages positively rated for the individual patient?
Which are the expected, desired or non desired outcomes applying the new method to this
particular patient?
·
The scientific evaluation (1,2):
Are the effectiveness and risks of the
method referring to the indication proven by a sufficient number of cases and
by applying scientifically correct statistics to allow a reliable evaluation?
Which is the level of studies according to
evidence based medicine (EBM), when integrating clinical experience and patient
values with the best available research information?
Which are the results categorizing
different types of clinical evidence and ranking them according to the strength
of their freedom from the various biases that beset medical research?
Randomized and controlled studies and their systematic reviews are usually
attributed to the highest value of perception. But one has to be careful when
transferring the results to multimorbid elder people,
because they are usually excluded from studies which usually concentrate only
on one disease or one method.
Are there studies performed in several centres, independent from each other, confirming the
results at the same or differing level of evidence?
Is the verification of methodical
effectiveness severely impeded? This may be the case if diseases are seldom
occurring and the etiology and course of the disease is not clear.
Is there a broad feedback following the
discussion of experts? This may be documented by the number and quality of
publications, publication in peer-reviewed medical journals, meta-analyses,
evaluation of reviews, textbooks, guidelines, expert opinions and consensus
conferences and editorials. Multiple publications authored by the same study
group with changing first authors do not account for a broad resonance
specialist discussion.
Is the method applied by a substantial
number of medical doctors? Epidemiologic health-care data are useful.
·
Insurers and Policy Makers to
evaluate economic potentials and regulatory challenges (1,2):
Which are the
costs for an individual?
Which is the
cost-benefit ratio for an individual?
Which is the
cost-benefit ratio for the community of all insured persons?
Which is the
cost-benefit ratio with regard to the long range impact assessment?
Which is the
cost-benefit ratio compared to other methods with equal outcome effects?
Which are the
necessary regulations to initiate in case the new method should be transferred
into routine health care?
Which are the
necessary regulations to withdraw elder and no longer necessary methods from
the market or in social health systems from a financing through the social
health community?
Which are the
necessary regulations to initiate and secure a sound financing and controlling
of the insurances` financing?
Which are the
necessary regulations to sanction medical doctors applying not recognized,
useless or even harmful new technological methods in the treatment of their
patients?
An evaluation
applying the same method in all cases may not be appropriate for any disease,
any method of new medical technologies or any issue. It must be adjusted to the
medical technology itself, the claimed indication and the relevant clinical
parameters. Furthermore, the evaluation of obtained information that is
relevant to solve the upcoming questions must be executed sophisticated.
The evaluation is
respectively carried out considering the pursued aim of treatment on an
individual basis or considering the community of all insured persons. A critical
appraisal of relevant information is needed to find an answer to the above
mentioned key questions referring to original research articles. Abstracts are
not sufficient to appreciate the quality of a publication since they do not
allow the evaluation of the evidence based integrity of the study and its
results.
Poor evidence
leads to poor clinical decisions. Following the above mentioned key questions
may be helpful to make decisions about the individual and / or massive scale
application of new medical technologies to the best medical knowledge and
consciousness. Its goals are to secure the best care quality corresponding to
the state of the art and to protect patients against commercially led,
ideologically superimposed or personally guided interests. Orienting towards a
sound scientific basis and respecting the framework conditions of the varying
medical care systems may help to optimize the information, cooperation and
informed consent of patients, medical doctors, insurers, health policy makers and
lawyers.
3. Declaration of conflicts
No conflicts
4. Authors’ biography
Prof. Dr. med. Wolfgang Seger, Professor for
Rehabilitation Medicine, University of Bremen, Germany. Specialist in Internal
Medicine, Gastroenterology, Social Medicine and Rehabilitation Medicine.
Chairman of the Medical Health Advisory Board of the Statutory German Federal
Association for Rehabilitation. Longstanding Medical Director and Deputy CEO,
Advisory Board of all Statutory Health and Long Term Care Insurances in Lower
Saxony, Germany, now freelance expert in Social Medicine.
5. References
1.
Instructions manual to evaluate non-contractual new medical technologies
(in German language): Begutachtungsanleitung
Außervertragliche „Neue Untersuchungs- und Behandlungsmethoden (NUB)“,
Medizinischer Dienst des Spitzenverbandes Bund der Krankenkassen e.V.(MDS) Essen,
Germany, 2008, http://www.mds-ev.org
2.
Cochrane Library with methods studies following
evidence based medicine (EBM): http://www.cochranelibrary.com