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M. López-Cano and J. M. García-Alamino
occasions, the clinical problem may be associated with a high morbimortality, and a CPG may
be necessary to reduce it, whereas, in other cases,
development of a CPG may be justied if diagnostic studies or treatment modalities are costly
or can cause adverse events.
7.2.5 Steps intheDevelopment
ofaCPG
Basic steps in the development of a CPG have
been described and dened almost three decades
ago [10].
7.2.5.1 Selection oftheProblem
toBeEvaluated
Selection of the health-care problem to be evaluated is closely related to the aforementioned reason for developing a CPG. The selected topic
may be a disease (condition) or a procedure
(diagnostic or therapeutic). In any case, “rening” the selected topic is a crucial aspect [13].
The usual way of rening the topic is by a dialogue among clinicians, patients, and potential
users and/or evaluator of the guideline. If the
question is not rened, the problem may be too
broad in scope and difcult to approach [13].
Formal methods have been developed to establish
priorities in the selection of topics [14, 15].
However, as previously stated, it is essential to
establish a dialogue among all persons involved
(patients, clinicians, users, evaluators), including
group members responsible for developing the
CGP.
7.2.5.2 Group Members
Although the exact number of members forming
the group for developing a CPG has not been
dened, ideally the group should have at least six
but not more than 12–15 members [13] (including members and leaders). This seems reasonable
as too few members limit adequate discussion,
and too many members make effective functioning of the group difcult. The group usually consists of surgeons and other professionals involved
in health care, such as nurses, experts in methodology (epidemiologists, statisticians), and health
economists; patients and representatives of the
pharmaceutical industry are sometimes included.
A multidisciplinary group identies different
“perspective” of the evidence [10]. When presented with the same evidence, single specialty
group will reach different conclusions than a
multidisciplinary group because the specialty
group may be systematically biased in favor of
using or recommending procedures in which it
has special interest [16, 17]. It is important to
include surgeons in the group to contextualize the
recommendations in the framework of clinical
practice. Once the group members have been
established, the role of the leader or leaders
includes developing a work timetable adapted to
available resources, distribution of tasks among
the group members, denition of the guideline
structure, planning strategies for diffusion of the
guideline, and implementation of the guideline
specifying criteria, deadlines, and evaluation
methods. An important aspect among participants in developing CPGs is to disclose academic
and economic conicts of interest.
7.2.5.3 Development oftheCPG
The process of developing a CPG also includes
different phases. Health-care problems addressed
in guidelines are commonly quite broad, so that it
is important to set the boundaries for diagnostic
and/or therapeutic questions to which responses
are wanted to be obtained. The identication of
possible preventive, diagnostic, or therapeutic
interventions involved in the CPG should be
decomposed and organized using the PICO strategy [18, 19]. PICO represents an acronym for
patient (P), intervention (I), comparison (C), and
outcome (O). These four components are the
essential elements of the research question and of
the construction of the question for the bibliographic search of evidence [20]. The adequate
(well-constructed) PICO strategy allows for the
correct denition of which information (evidence) is needed to solve the clinical research
question and maximizes retrieval of relevant
studies in the search of databases, avoiding
ineffective literature search. Denition of the outcome, in other words, the measure of the effect of
the intervention [18–20], is probably the most
important component. Also, the PICO strategy
allows selection of the search terms (i.e., biblio-
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83
graphic search for evidence), known as “descriptors” or “keywords,” which are used to perform a
systematic review of the literature in the most
relevant electronic databases, including
MEDLINE (PubMed), EMBASE, SCOPUS,
Cochrane library, Web of Science, and Google
Scholar. For practical purposes, even each question can become a systematic review with its corresponding meta-analysis if appropriate, the
search will have no language restrictions [21,
22], and the process for each question will be
documented with a ow chart [23]. Selected documents should cover as much as possible the
available literature, including all types of studies
(randomized controlled clinical trials [RCTs],
observational studies, epidemiological studies,
cost-effectiveness analyses, book chapters, etc.).
All studies identied should be screened by reading the title and the abstract to assess whether
information is pertinent to the PICO question.
Full-text articles should be obtained for eligible
studies. Also, using explicit rather than implicit
criteria should improve the reliability of the process [13].
Once relevant studies have been identied,
data extracted should be summarized, categorized, and interpreted. Since “denitive” evidence exists for relatively few health-care
procedures, deriving recommendations solely in
areas of strong evidence would lead to a CPG of
limited scope or applicability [13, 24, 25].
However, more commonly the evidence needs to
be interpreted into an “opinion” context (clinical,
public health, policy, and/or economic context).
Therefore, within the guideline development process, a decision should be taken about how opinion will be both used and gathered.
Different methods for categorizing, grading,
and interpreting the quality of evidence extracted
from the literature and to establish the strength of
recommendations are used, sometimes only by
the group or organization that developed the
guideline [26]. It is not the purpose of this chapter to present a detailed description of these
methodologies, but the method used is a crucial
factor for the user’s condence in the information
provided by the CPG.Since 2000, the Grading of
Recommendations Assessment, Development
and Evaluation Working Group (GRADE) com-
posed of international epidemiologists, methodologists, and clinician experts developed a system
that separates grades for the quality of evidence
and for the strength of recommendations, a consensus that can overcome limitations of previous
systems [27]. The GRADE system has been
adopted by more than 70 organizations worldwide, including the World Health Organization
(WHO), Cochrane collaboration, the National
Institute for Care and Health Excellence (NICE),
or the Scottish Intercollegiate Guidelines
Network (SING) [28]. The GRADE system will
become the dominant method for classifying the
quality of evidence and strength of recommendations of CPGs in the near future [29].
7.2.6 The GRADE Approach
GRADE differentiates from other systems in
which it assesses importance of the results of
interest for clinicians and patients with a clear
separation between quality of evidence and
strength of recommendations, applies explicit
criteria to raise or upgrade or to reduce or downgrade the quality of evidence independently of
the study design, considers patients’ values and
preferences, and nally follows a structured and
explicit process for development of recommendations [28].
Probably, there are two key aspects in the
GRADE methodology. Firstly, the system is based
on the outcome (extracted from all evaluated studies) because in GRADE not all outcomes are similar or have the same relevance (i.e., critical,
important, but not critical) and only the most
important outcomes should inuence upon assessment of quality of the evidence and strength of
recommendations [30]. Secondly, condence in
the available evidence is based on the quality of
evidence, dened as condence that the estimates
of an effect are adequate to support a recommendation [31]. The level of the quality of evidence
can be “high” (high condence that the estimate
of the effect from the available literature is very
close to the true effect), “moderate” (the estimate
of the effect is close to the true effect, but there are
many substantial differences), “low” (the estimate
of the effect may be substantially different from
84
Select outcomes
M. López-Cano and J. M. García-Alamino
the true effect), and “very low” (it is very likely
that the estimate of the effect is substantially different from the true effect).
On the other hand, different objective factors
may affect the quality of evidence, upgrading or
downgrading the condence that can be placed
in the estimation of the effect. It is also recognized that the expert opinion inuences the evaluation of the available evidence, but it is not
considered a type of evidence in itself [28].
Objective factors include (1) limitations in
design or conduct (risk of bias) for RCTs (e.g.,
lack of concealment of the randomization
sequence, inadequate blinding, or substantial
loss to follow-up, etc.) and observational studies
(inappropriate population selection criteria,
insufcient control of confounding factors, etc.)
[32], (2) inconsistent or heterogeneous results
(i.e., results from the various studies extracted
from the literature are very different for the
same outcome) [33], (3) lack of direct evidence
for an outcome being only indirect evidence
available [34], (4) imprecise results related to
the number of patients analyzed in the different
studies, the effect estimator and its condence
interval [35], and (5) suspected publication bias,
that is, suspicion that not all studies, primarily
those with negative results, have been published,
so there is a possibility that the effect may be
overestimated [36].
The GRADE system allows the evidence to be
combined in a summary of ndings (SoF) table,
which gives a structured outline of the number of
studies for each outcome of interest, quality of
evidence, and the results observed in relative and
absolute terms. These SoF tables can be generated using a free download software program
called GRADEPro [37].
Finally, recommendations and strength of recommendations are established by the GRADE
system. According to GRADE, four basic factors
inuence the strength of recommendations: the
risk-benet balance, quality of evidence, patient
values and preferences, and costs and resource
utilization [38]. Strength of recommendations
has different implications for patients, clinicians,
and policy makers. A strong recommendation for
patients would be that most people in your situation would want the recommended action and
only a small proportion would not; for clinicians,
that most patients should receive the recommended action; and for policy makers, that the
recommendation can be adopted as health-care
policy in most situations. By contrast, a weak
recommendation for patients would be that most
people in your situation would want the recommended action, but many would not; for clinicians, that different choices would be appropriate
for different patients and that doctors must help
each patient to arrive at a management decision
consistent with his/her values and preferences;
and for policy makers, that there is a need for
substantial debate and involvement of
stakeholders.
Synthesis of the GRADE process is shown in
Fig.7.2.
PANEL
DISCUSSION
GUIDELINES
Fig. 7.2 Main steps in the development of CPGs (GRADE system)
Formulate question
[PICO]
Rate importance
(citical, important)
Recommendation
Outcomes
across studies
(strong,weak)
Summary of findings table
GRADEpro
PANEL
DISCUSSION
Rate quality of evidence
for each outcome
High
Moderate
Low
Very low
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7.3 Drafting, Reviewing,
andUpdating CPGs
The appropriate style, language, and content of a
CPG follow a series of general recommendations
established for decades by different institutions.
The Institute of Medicine [39] recommends CPG
structure based on validity, reliability, reproducibility, applicability, and clinical exibility, clarity, and explicit mention of the multidisciplinary
process, as well as references to the documents
used. Other institutions, such as the American
Medical Association [40], recommended a number of attributes that should characterize a wellwritten and structured CPG as having as to be
written and developed by or in conjunction with
medical organizations, should be specied that
the guideline was developed with appropriate
methods that integrate the ndings of the literature with adequate clinical experience, should be
as comprehensive and specic as possible, should
be based on current information, and should be
widely disseminated. Areas in which further
research is needed should be explicitly
mentioned.
The nal draft should undergo a process of
external review to ensure validity, clarity, and
clinical applicability of the CPG. External
reviewers should cover three areas: people with
expertise in clinical content, who can review the
guideline to verify the completeness of the literature review and to ensure clinical sensibility;
experts in systematic reviews or guideline development, or both, who can review the method by
which the guideline was developed; and potential
users of the guideline, who can judge its usefulness. The Appraisal of Guidelines for Research
and Evaluation (AGREE) [41] is probably the
most popular tool for the assessment of CPGs.
The original AGREE instrument has been
updated and methodologically rened. The
AGREE II is now the new international tool for
the assessment of practice guidelines. The
AGREE II is both valid and reliable and comprises 23 items organized into the original six
quality domains: (1) objective and purpose, (2)
stakeholder involvement, (3) rigor of development, (4) clarity of presentation, (5) applicability,
and 6) editorial independence.
The guideline can be updated as soon as each
piece of relevant new evidence is published, but it
is better to specify a date for updating the systematic reviews that have been the supporting articles
of the guideline [13].
7.4 Implementation ofCPGs
Unfortunately, there is no single effective way to
ensure the use of guidelines in practice [42].
Despite creation of CPGs at national and international levels, guidelines are underused by clinicians at the bedside to improve patient care.
Effective implementation of CPGs requires assessment of barriers and facilitators in utilizing guidelines and to develop strategies tailored to local
circumstances [43, 44]. Implementation of CPGs
and evidence in general requires changes in the
system involving both individuals and health-care
settings [45–47]. Poor adoption of CPGs has been
attributed to physician’s attitudes and values, conicting patient goals and expectations, and organizational characteristics. Specically, clinicians
hesitate to adopt CPGs because of personal opinions, competences, attitudes, personal characteristics, or motivation for change [46]. Also, some
doctors may be highly inuenced by the opinion
of other experts, and sometimes local consensus
may facilitate the use of a CPG to a more extent
than quality of evidence or dissemination of the
CPG [48]. Patients’ age, sex, or race can play a
role in clinical decision-making. Organization and
structure of clinical care settings are important for
facilitating material resources (facilities, equipment) and time for implementation of guidelines.
Economic measures of the organizational context
may favor or prevent implementation of new activities [49]. Finally, as mentioned above, writing of
guidelines should be kept simple and recommendations clearly described and with methodological
rigor [50, 51].
7.5 Benets ofCPGs
The principal benet of guidelines is to improve
the quality of care received by patients. Potential
benets are extensive not only to patients but also
86
M. López-Cano and J. M. García-Alamino
to health-care professionals and health-care systems [12]. In relation to potential benets for
patients, guidelines that promote interventions of
proved benet and discourage ineffective ones
have the potential to reduce morbidity and mortality and improve quality of life [12]. Guidelines
available in accessible media (i.e., Internet sites,
webs of scientic societies) empower patients to
be informed, to consider their personal needs and
preferences, and to establish an open dialogue
regarding best options and potential outcomes
[12]. Guidelines can help patients by inuencing
public policy, calling attention to services or
interventions that may be made available as a
response to newly released CPGs.
With regard to health-care professionals,
CPGs can improve the quality of clinical decisions, clarifying which interventions are of
proven benet based on a critical and systematic
assessment of scientic evidence. They alert clinicians to interventions unsupported by good science, reinforce the importance and methods of
critical appraisal, and call attention to ineffective,
dangerous, and wasteful practices. Clinicians
may turn to guidelines for medicolegal protection
or to reinforce their position in dealing with
administrators who disagree with their practice
policies.
For health-care systems, CPGs are effective in
improving efciency and optimizing expenditures and investments. Implementation of certain
guidelines reduces expenses related to hospitalization, prescription drugs, surgery, and other
procedures. Adherence to guidelines may also
improve public image, sending messages of commitment to quality and excellence [52].
7.6 Potential Limitations ofCPGs
The most important limitation of guidelines is
that the recommendations may be wrong. Three
important reasons have argued. Firstly, scientic evidence in general medicine and surgery,
in particular, is often lacking, misleading, or
misinterpreted, and only a small subset of what
is done in medicine and surgery has been tested
in appropriate well-design studies [12, 53].
Secondly, recommendations are inuenced by
the opinions and clinical experience and composition of the expert development group. The
beliefs to which experts subscribe, often in the
face of conicting data, can be based on misconceptions and personal experience that may
misrepresent the general situation [54]. Conicts
of interest of guideline developers may also be
considered. Thirdly, patient’s needs may not be
the only priority in making recommendations.
Practices that are suboptimal from the patient’s
perspective may be recommended to help control costs, serve societal needs, or protect special interests (e.g., those of doctors, risk
managers, or politicians).
Conclusion
CPGs are not “cookbook medicine” where
solutions to all specic health-care problems
can be found. The same parties that stand to
benet from guidelines—patients, health-care
professionals, and the health-care system—
may all be harmed by awed CPGs [12].
Clinical guidelines are only an option for
improving the quality of care and make sense
when clinicians are unclear about appropriate
practice and when reliable scientic evidence
can provide an answer.
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Creation, Advantages, andLimits
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ofRegistries: TheHerniamed
Experience
F.Köckerling
8
8.1 Introduction
Several developments in healthcare, such as
progress in information technology and increasing demands for accountability, have led to an
increase in the number of medical registries over
the recent years [1]. A medical registry is dened
as a systematic collection of a clearly dened set
of health and demographic data for patients with
specic health characteristics, held in a central
database for a predened purpose [1]. Medical
registries can serve different purposes—for
instance, as a tool to monitor and improve quality
of care and as a resource for outcome research
[1]. The ultimate aim of the noncommercial project Herniamed, founded in 2009, is to improve
quality standards across the entire spectrum of
hernia surgery and to implement outcome
research projects in hernia surgery [2]. With
widespread recognition that surgical outcomes
vary by provider, surgeons and hospitals are
increasingly being asked to provide evidence of
the quality of care that they deliver [3]. Another
high priority area for registries is medium to
long-term monitoring of specic devices and
procedures [4]. Devices may malfunction, break,
and cause injury because of misuse or design
F. Köckerling
Department of Surgery and Center for Minimally
Invasive Surgery, Academic Teaching Hospital of
Charité Medical School, Vivantes Hospital,
Berlin, Germany
e-mail: ferdinand.koeckerling@vivantes.de
aws [4]. Unlike new drugs, devices are commonly incorporated into medical practice without
systematic pre-marketing evaluation of their clinical safety [4]. Systematic surveillance by registries can provide a greater level of consumer
protection [4].
8.2 Creation ofHerniamed
In Germany, around 275,000 inguinal hernia procedures and nearly 100,000 abdominal wall hernia operations are carried out each year. Despite
the high frequency of such surgical hernia procedures, the overall results are not at all satisfactory. In Germany, the recurrence rate and the rate
of chronic pain following inguinal hernia surgery
are more than 10% [2].
The noncommercial, nonprot project
Herniamed was founded in 2009 to implement a
quality assurance and outcome research project
in hernia surgery. This is a network of surgeons
mainly from Germany, Austria, and Switzerland,
who have a special interest in hernia surgery.
Thanks to the creation of an English language
version, it has already been expanded to an international network [2].
From the beginning, the project was strongly
supported by the German Hernia Society
(DHG) and the Surgical Working Group Hernia
(CAH) of the German Society of General and
Visceral Surgery (DGAV). The board members
of both societies are also board members of
Herniamed.
© Springer International Publishing AG, part of Springer Nature 2018
G. Campanelli (ed.), The Art of Hernia Surgery, https://doi.org/10.1007/978-3-319-72626-7_8
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F. Köckerling
The cornerstone of the Herniamed project is
the Internet-based registry into which all interested hospitals and surgeons can enter data on all
hernia operations performed by them, using a scientically corroborated standard approach [2].
All patient data recorded in the Herniamed registry are entered prospectively into the database
with the hernia types being classied as per the
valid classication system of the European
Hernia Society (EHS). The patient’s data are
saved only after obtaining his informed consent
and can be deleted at any time upon the patient’s
request. The online-based outcome research and
quality assurance project meets the most stringent data protection criteria [2].
As the German Hernia Society (DHG) and the
Surgical Working Group Hernia (CAH) have created a certication program of hernia centers,
participation in the quality assurance tool
Herniamed is obligatory for certied hernia centers involving follow-up of their patients [5].
Hernia centers and their outcome quality
gained by participation in the Herniamed quality
assurance program are veried and evaluated in
regular audits by independent experts appointed
by the German hernia societies [5].
As a nonprot organization, Herniamed is
dependent from donations of the medical device
industry. To date, participation in Herniamed is at
no charge. A benchmark tool allows surgeons or
hospitals to compare their results at any time with
the total patient population in the registry. A discrepancy in the outcomes is the motivation for
measures improving the own surgical quality.
Participation in the quality assurance program
like Herniamed is therefore an indispensable part
of certication demands of hernia centers set by
hernia societies.
8.3 Advantages ofRegistries
8.3.1 Quality Improvement by
Registries
In a leading article of the Wall Street Journal,
Clifford Ko, a Colorectal Surgeon at UCLA,
Director of the National Surgical Quality
Improvement Project, gave the following statement: “You can’t improve a hospital’s quality if
you can’t measure it” [6].
Registries can provide sound data needed by
clinicians and organizations to improve patient
safety and quality of care [7]. The national Danish
Hernia Collaboration with two annual meetings
discussing own results and those of others has led
to >50% reduction in reoperation rates [8].
Establishment of a nationwide groin hernia database leads to general improvement in outcomes
[8].
Systematic prospective recording of treatment
and outcome variables in a national clinical database improved the overall quality of surgical care
[9]. One cannot deny that the sharing and comparing of data with similar colleagues and a measurement of one’s performance relative to the
collective benchmark are likely to improve the
safety and quality of healthcare rendered [10].
Clinical-quality registries aim to improve quality
of care through benchmarking clinical outcomes
and stimulating competition in achieving best
practice [7]. In addition to providing information
on safety and efcacy of treatment, data from
registries can also be used to determine whether
care is delivered in line with best practice and
evidence-based guidelines [7].
8.4 Registry-Based Research
Randomized clinical trials (RCTs) and metaanalyses are considered to be the gold standard of
evidence-based medicine nowadays [11]. The
strength of the RCTs rest on its excellent internal
validity, which is based largely on the power of
randomization to ensure that the only difference
between two treatment arms is their exposure to
the treatment of interest [12]. But the applicability of RCTs to the care of patients in routine practice is limited [12]. In particular, patients,
providers, and concurrent care in the general
population are different from those in RCTs, and
the generalizability or external validity of RCTs
may be limited [12]. Although observational
research does not enjoy the same level of internal
validity as RCTs, well-designed observational
8 Creation, Advantages, andLimits ofRegistries: TheHerniamed Experience
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studies can offer superior external validity and
provide a unique opportunity to evaluate treatment and their outcomes in routine practice [12].
Many important clinical questions have not, cannot, and will not be ever addressed in the context
of an RCT [12]. In a comparison of observational
studies and RCTs, the estimates of the treatment
effects from observational studies, and RCTs
were similar in most cases [13]. Registries are
ongoing prospective observational data-collection exercises from as many eligible patients as
possible [7]. Hernia registries are existing in
Sweden since 1992 [14]; in Denmark since 1998
[15–17]; in Germany, Austria, and Switzerland
since 2009 [2]; in France since 2011 [18]; in
Spain since 2012 [19], in Europe since 2012 the
international hernia registry EuraHS [20]; and in
the United States since 2013 [21]. Registry-based
observational studies in hernia repair deliver realworld data from very large patient populations
and give answers to important clinical questions
never evaluated in RCTs [22]. In a review about
data and outcome of inguinal hernia repair in hernia registries, 85 articles from registries were relevant [22]. It can therefore be stated with certainty
that, for scientic evaluation of hernia surgery,
RCTs and registry-based observational studies
are partners in the evaluation of medical evidence
[12, 22]. A standardized reporting of outcome in
hernia surgery will increase the quality of
research by RCTs and registries [23].
8.5 Registries intheEarly
Scientic Evaluation
ofSurgical Innovations
By contrast with the formalized approach for
drug development, the innovation process in surgery has been unregulated, unstructured, and
variable [24]. The Balliol Collaboration encourages the widespread use of prospective databases
and registries to document the outcome in the
early scientic evaluation of surgical innovations
[24]. All scientists engaged in surgical innovations are called upon to support and promote the
development of such registries [25]. Surgeons
who themselves create innovations should enter
data into a registry on patients treated as per the
innovative technique [25].
8.6 Cost ofRCTs vs. Registries
Over the last several decades, the cost associated with conducting RCTs has increased dramatically [26]. Several factors contribute to
higher cost associated with clinical trials [26].
Important barriers to conducting surgical RCTs
identify funding sources available to nance
RCTs [26]. Surgical grant proposals are less
likely to be funded and carry signicantly
smaller awards compared to nonsurgical proposals [27]. One third of hospital admissions
involve surgery, but less than 2% of government
funding for medical research goes into surgical
areas [28]. The cost per enrolled subject in surgical RCTs range from 400 to 1600$ [26]. The
cost per enrolled subject in Herniamed is around
2$. So registries can play an important role as a
research tool for underfunded research in the
surgical eld. By virtue of the ever-expanding
number of medical devices used in hernia surgery (meshes, tacks, glues), the surgical techniques are of such a brood variety that they can
scarcely be evaluated in RCTs [25]. But by consistently recording details of the different surgical techniques in a prospective registry, any
problems or complications related to particular
variants of the technique can be identied at an
early stage.
8.6.1 Registries inthe
Postmarketing Surveillance
ofSurgical Products
To date, surgical meshes are classied as group II
medical devices. Class II devices do not require
pre-market clearance by clinical studies [29].
Ethicon initiated a voluntary market withdrawal
of Physiomesh for laparoscopic use after an analysis of unpublished data from the two large independent hernia registries—Herniamed Registry
and Danish Hernia Database [29]. The data from
Herniamed Registry are published meanwhile
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