Key words
guideline - DGGG - AWMF - development - organisation
Schlüsselwörter
Leitlinie - DGGG - AWMF - Entwicklung - Organisation
Introduction
Matthias W. Beckmann (Erlangen) has confirmed his succession of Rolf Kreienberg (formerly
Ulm) in
December 2012 as DGGG Guidelines Commissioner and was confirmed by the DGGG Board
of Directors.
Previously, Rolf Kreienberg became a member of the Executive Committee of the AWMF
and Director of the
permanent “Guidelines” commission of the AWMF in May of 2013. The DGGG Guidelines
programme is supported
by the DGGG Guidelines Commission, which consists of members of the individual focus
groups (FG) of the
DGGG ([Fig. 1]). The structure and the resulting responsibilities and tasks
of the newly established guidelines programme are subject to the changing times. The
professional
handling of guidelines within other societies has led DGGG to pursuing this central
restructuring. In
particular, this concerns comprehensive and transparent organisation (registration,
communication
processes, etc.), commissioning the creation of guidelines, as well as clearly regulated
procedures via
the DGGG Guidelines Commission and the DGGG Board of Directors in cooperation with
the Association of
the Scientific Medical Societies in Germany (AWMF). The process of guideline creation
is the foremost
issue [1], [2], [3].
Fig. 1 Overview of the DGGG Guidelines Commission.
In the run-up to working on structured guidelines, detailed knowledge of AMWF regulation
[4] in the current version 1.0 and familiarity with the specific nomenclature is
beneficial. For example, the AWMF differentiates between
-
“current guidelines” [5],
-
“pending guidelines” [6] and
-
“expired guidelines”.
The first point of the classification defines valid guidelines with a definitive period
of validity
(designation from beginning to end). For current guidelines, this is between 3–5 years.
The second point
of the classification is defined by a concrete registration procedure for new guidelines
or guideline
revisions.
Policy (Levels of Classification)
Policy (Levels of Classification)
It is mandatory to define the classification stage of guidelines at the beginning
of planning. This is
the yardstick for later monetary, organisational and time expenditures. There are
three levels: the
lowest stage (S1), the middle stage (S2) and the highest stage (S3) [2], [4].
The lowest class is defined by a compilation of recommendations for actions by a non-representative
group
of experts. The methodical generation of a consensus here is of little importance
compared to the other
guideline stages.
In 2004, Stage S2 was split into two sub-stages, one based on evidence research (S2e)
and the other based
on structural consensus (S2k). From practical experience, doing only evidence research
of current
literature is preferred by many past guideline authors as opposed to the documented
and structural
finding of a consensus by a representative panel. The highest Stage S3 combines the
two procedures into
a complete work of highest methodological relevance.
Nomenclature
AWMF register number/Guideline title
The next step is registering with the AWMF with a registration number. This unique
AWMF register
number will be part of a guideline throughout its life. The syntax (XYZ/XYZ) has two
parts. The
first three digits define the responsible AWMF society (only one entry is possible
with multiple
jurisdictions). The last three digits are for creating a continuous identification
number for the
guidelines. The combination of the two parts provides a unique register number and
formally
differentiates between a guideline and an advisory opinion on stage S1. Binding guidelines
and, for
example, horizontal guidelines of the German Medical Association are not included.
In some cases,
the guidelines title can be changed when revisions include new topics. Approval of
the DGGG
Guideline Secretariat is required. This shall not unduly complicate later matching
of past
guidelines.
Leading/participating society(s)
Also, the representatives or delegates of the participating AWMF society or non-AWMF
society/organisation/lobby are expressly mentioned in the registration process and
later in the
published version. Not every society can register guidelines with the AWMF. To date,
the AWMF has
registered 168 select societies (as of January 2014) via a transparent registration
procedure.
During the admission procedure, the society must meet 10 admission criteria in order
for their
application to be approved by a three-quarter majority of the Delegates Conference
that takes place
twice a year. Nevertheless, non-AWMF societies can participate in the creation of
guidelines but
cannot register them themselves. Their participation is actually expressly desired.
The defined
interest group or target group of specified guidelines principally requires their
representation for
the creation of those guidelines.
Author of guidelines/elected representative
In order to make the development process effective on the part of the authors, it
makes sense to
appoint a lead author or coordinator in/for the control group. This appointee is responsible
for
communication with the DGGG Guidelines Secretariat and coordinates the registration
and creation
process. The team of authors consists of elected representatives of the focus groups
(FG) of the
DGGG and the expert and/or non-expert societies/organisations. Specifically, the elected
representative of the DGGG FGs are not appointed by the lead author of the guidelines
in this new
guidelines programme procedure, but instead are recommended by the respective FG following
an
enquiry about such by the lead guidelines author. The elected representative to-be
is either
confirmed or rejected by the DGGG Guidelines Commission or the representing DGGG Guidelines
appointee. The same scenario applies to the lead author him/herself. This newly established
procedure provides for maximum transparency when it comes to the selection of elected
representatives.
Versions of guidelines documents
The AMWF policy allows guideline authors to publish their guidelines in differently
edited versions.
There must be no subject unconformities in the synopsis of all versions. Besides the
long version,
common versions are short versions/practice versions published in journals, a patient
version, an
international long or short version in English, and now also a DIA version. So far,
7 DIA versions
are published on the AWMF homepage ([Table 1]) and additional DIA
versions are being worked on. This version serves to preserve the thematic link to
the long version
by summarising all statements. This means, all DIA versions or single slides can be
distributed or
used in training events (seminars, conferences, etc.) without any problems. The template
for the DIA
version is provided by the DGGG Guidelines Secretariat ([Fig. 2]). The
first illustrative example was and is the guidelines coordinated by Prof. Dr. Uwe
Ulrich from Berlin
for the “015-045 Diagnosis and treatment of endometriosis” [7].
Fig. 2 DGGG template of DIA version.
Table 1 Already published DIA versions (as of 19 February
2 014).
AWMF number
|
Guideline title
|
015-005
|
Stress incontinence in women[14]
|
015-023
|
Vaginal operative deliveries [15]
|
015-028
|
Bacterial vaginosis in Obstetrics and Gynaecology [16]
|
015-045
|
Diagnosis and treatment of endometriosis"[7]
|
015-052
|
Female genital malformations [17]
|
015-071
|
Treatment of inflammatory breast diseases during lactation [18]
|
032-035
|
Diagnosis and treatment of malignant ovarian tumours [19]
|
Guideline Status
The processing of all guidelines that have been published to date has been enormously
taxing on the DGGG
Guidelines Secretariat. This concerned cataloguing and chronological cataloguing of
all digital
guidelines found. Only since 2004 have they been available in digital format. Of these
400 versions,
almost 260 guidelines (long versions) are currently invalid and therefore have no
direct clinical
relevance. The legal relevance, especially in the context of expert processes, forced
the long-term
availability of all of these documents in the guidelines secretariat and they are
therefore also
available to DGGG members and interested parties. A system was created for cataloguing
these guidelines.
Besides the unique date and numerical assignment of the guidelines version, a new
“Present status” was
implemented. It is divided into the following values:
-
Valid: As a valid guidelines it corresponds to the “current guidelines” of the AWMF [5].
-
New: Corresponds to a planned new publication of a set of guidelines. This status can
be
temporarily found as “registered guidelines” of the AWMF [6] only if
the registration procedure has been completed.
-
Revision: Corresponds to guidelines that are currently being revised. This status can be
temporarily found as “registered guidelines” of the AWMF [6] only if
the registration procedure has been completed. After a set of guidelines has been
created, this
status changes to valid if it was successful or expired if it has failed.
-
Expired: Corresponds to guidelines that are no longer valid. This status is temporary for
one year. If the content is being revised, that status of the guidelines changes to
Revision, or if there is no revision it changes to Archived. Since the
beginning of January 2014, these guidelines are available for download from the DGGG
homepage
and accessible to all interested parties [8].
-
Archived: Corresponds to a set of guidelines after the expiration of one-year with an
Expired status. Since the beginning of January 2014, archived guidelines are
available for download on the DGGG homepage and are accessible to all interested parties
[8]. These archived guidelines often have duplicate entries (AWMF
number with guidelines title), depending on the number of revisions. For this status,
a
sub-status was established at a later point in time. It is called transferred and
corresponds to a set of guidelines, which, after consultation with the author of the
guidelines,
is transferred to guidelines of a different name or has been transferred already ([Table 2]). It will not be published in the future.
Table 2 Archived guidelines which were transferred to other guidelines or planned
guidelines (as of January 2014).
AWMF number
|
Guideline title
|
AWMF number
|
Guideline title (transferred to)
|
015-021
|
Antenatal care and labour induction with status post C-section
|
–
|
Possibly new C-section guideline
|
015-022
|
Presence of fathers in C-sections
|
–
|
New C-section guidelines
|
015-046
|
Placenta disorders in status after C-section
|
–
|
New C-section guidelines
|
015-054
|
Absolute and relative indications for C-section
|
–
|
New C-section guidelines
|
015-056
|
Postoperative monitoring of C-section patients
|
–
|
New C-section guidelines
|
015-064
|
Laparoscopic supracervical hysterectomy (LASH)
|
–
|
New hysterectomy guidelines
|
015-012
|
Postpartum disorders of bladder and pelvic floor function
|
015-005 015-006
|
Stress incontinence [10], [14]
Descent in women [20]
|
015-013
|
Bladder emptying disorders
|
015-005 015-006
|
Stress incontinence [10], [14]
Descent in women [20]
|
015-037
|
Contraception in women with type 1 and type 2 diabetes mellitus
|
015-015
|
Contraception
|
015-014
|
Urogenital atrophy
|
015-062
|
Hormone therapy in peri- and postmenopause [21]
|
015-033
|
Recommendation for sonographic diagnosis in asymptomatic postmenopausal patients
|
015-062
|
Hormone therapy in peri- and postmenopause [21]
|
015-038
|
Consensus recommendations for hormone therapy (HT) in menopause and postmenopause
|
015-062
|
Hormone therapy in peri- and postmenopause [21]
|
015-042
|
Antifungal therapy of vaginal yeast colonisation
|
015-072
|
Vulvovaginal candidiasis
|
015-003
|
Laparoscopic surgery of ovarian tumours
|
032-035
|
Diagnosis and treatment of malignant ovarian tumours [11], [19]
|
015-009
|
Urinary tract infection of women
|
043-044
|
Urinary tract infections [22]
|
015-010
|
Urinary tract infection in pregnancy
|
043-044
|
Urinary tract infections [22]
|
015-041
|
Recommendations for Chlamydia trachomatis infection in pregnancy
|
059-005
|
Infections with Chlamydia trachomatis
|
DGGG Guidelines Programme Homepage
DGGG Guidelines Programme Homepage
In light of the new direction of the DGGG Guidelines programme, there was no way around
completely
redesigning the DGGG homepage (http://www.dggg.de/leitlinienstellungnahmen/). This process was split into three
phases:
Phase I was concluded in October 2013 and includes the following changes:
-
Link to the AWMF homepage for all currently registered guidelines authored by DGGG
or guidelines
that DGGG participated in. The different layouts of DGGG and AWMF were matched. The
primary
reason for this decision was the lack of transparency as to which version is or was
valid at
what point in time. A direct download to the guidelines without a link was available
for an
extended period of time, even though the guidelines may not have been valid any more.
The
document was not marked as expired or archived. This increased confusion and the
risk of erroneously assuming a document was valid. These direct links to the AWMF
will be
maintained by the DGGG office in Berlin from now on.
-
All new statements of the DGGG were issued a consecutive number. Similar to the guidelines,
this
will make it easier to match the statements in the future. Past statements were not
issued a
number.
Phase II will be concluded in the spring of 2014 and includes the following changes:
-
Making available all archived guidelines (2004–2012). This step was already concluded at
the beginning of January 2014.
-
Making available all archived statements. The goal is to have this step completed
by the end of
February 2014.
-
Expansion of offering of the following documents/links (only accessible to DGGG members)
[9] in context of the structural reform of the guidelines.
-
Structure paper as the basis of guidelines creation and guidelines structure,
-
Standard Operating Procedure (SOP Version 10. 10. 2013) marks the detailed flow and
communication channels of guidelines development/revision of guidelines ([Fig. 3]),
-
AWMF registration form as specially adjusted and partially pre-filled DGGG version
([Fig. 4]),
-
AWMF registration form (fill-in help) as specially adjusted DGGG version ([Fig. 5]),
-
Travel expense form for guidelines authors
-
Funding application for guidelines authors
-
Link to AWMF policy
-
Link to Conflict of Interest declarations (CoI) for guidelines authors
Fig. 3 Standard Operating Procedure (SOP) for guidelines organisation [9].
Fig. 4 Registration form (DGGG version) [9].
Fig. 5 Help for filling in the registration form (DGGG version), page 1 only [9].
Phase III should be concluded at the end of 2014 and includes the following changes:
-
Making available all archived guidelines (before 2004). These versions of the guidelines
are available in non-digital formats only. This chronological categorisation will
pose the
biggest challenge.
-
Further content and interface adjustments.
Publication
Full publication is one of the critical processes of guidelines work. The work, which
often takes several
years, must be publicised in an appropriate manner. A distinction is made between
the publication of all
guidelines documents (also full version) on the AWMF homepage and the versions for
international
distribution (short or long versions) in English. Previous guidelines were often published
in the
“Frauenarzt” (Gynaecologist) magazine. With the increased development of S2/S3 guidelines
of high
methodological quality from Germany, it was necessary to find a new publication outlet.
The DGGG
Guidelines programme has decided in favour of the “Geburtshilfe und Frauenheilkunde
(GebFra)”
(Obstetrics and Gynaecology), published by the Thieme Publishing [10], [11], [12], [13]. Listing
in the database of the National Library of Medicine (NLM), known as MEDLINE, is expected
in 2014. This
means that all guidelines versions published there can be found via pubmed.org or
other search
interfaces, at the very least as an abstract. This process will increase exposure
in English-speaking
territories enormously.
Workshops
To get to know better all processes of guidelines planning/organisation as well as
guidelines creation
(not covered here), the first workshop of the DGGG Guidelines programme was held on
18. 1. 2014 in
Erlangen. Based on this success, an additional workshop will be offered this year
for select guidelines
authors.
Overview of Tasks of the DGGG Guidelines Secretariat
Overview of Tasks of the DGGG Guidelines Secretariat
The tasks currently assigned to the DGGG Guidelines Secretariat in the context of
DGGG Guidelines
organisation are manifold and in part only briefly described here.
-
Planning, coordination and financing of the DGGG Guidelines programme
-
Registration of new or revised guidelines: new registration or update (guidelines
class
stays the same)/upgrade (guidelines class is raised, rarely downgraded) of existing
guidelines.
-
Communication with the participants
-
Communication with AWMF
-
Selection and concentration of topics
-
Ensuring the archiving of all guidelines/correspondence: in digital format for the
first
time thanks to a special document management program.
-
Participation in the DGGG Guidelines Commission meeting (2 ×/year)
-
Participation in the AMWF Delegates Conference (2 ×/year)
-
Maintaining the DGGG homepage with the numerous improvements thus far
-
Conducting workshops
-
Processing external requests (IQWIG, AQUA, DIMDI, medical associations, colleagues,
etc.)
-
Regular news updates via newsletter to all DGGG members
Objectives of the DGGG Guidelines Programme
Objectives of the DGGG Guidelines Programme
If the basis of the daily work is structured and economised, then the conditions for
the planning of new
goals are met. The prioritisation and rationalisation of issues across the entire
catalogue of
guidelines should be a new focal point. The focus should be on overriding issues and
with the assignment
of such to the responsible working groups of the DGGG. In doing so, the tight financial
and time
resources should be used in a more structured way, especially in terms of creating
guidelines. With
regard to the creation of guidelines with ever inter-disciplinary and inter-professional
cooperation,
this step seems to be inevitable. Another focus point is the improvement of international
distribution
of German guidelines. Thanks to the excellent cooperation of our Austrian and Swiss
colleagues in
committee work as well for the creation of new guidelines, the overall effort, which
is often
volunteered, can be reduced in this regard without risking a loss in quality. Of course
not all topics
and opinions can be combined due to country-specific differences.