Need for a Support System for the Constant Development of Korean Medicine Clinical Practice Guideline
Need for a Support System for the Constant Development of Korean Medicine Clinical Practice Guideline
Introduction
The project on the development of Korean Medicine Clinical Practice Guidelines
was set as the first strategic goal in the process of establishing the third
comprehensive plan for the development of Korean Medicine. The Guideline Center
for Korean Medicine (GKoM)—which is the main body of the project—is one year
away from the end of its six-year journey from 2016 to 2021, and therefore, we
would like to find out about the sustainable clinical practice guidelines
development system needed for the Korean medicine community through overseas
cases.
Overview of the Project on the Development of Korean Medicine Clinical
Practice Guideline
The project on the development of Korean Medicine Clinical Practice Guideline
(“Guideline”) was implemented from August 2015 to February 2016 with a wide
range of demand surveys participated in by the Society of Korean Medicine and its
affiliated associations as well as general Korean medicine doctors, and the final
priority of the 37 areas was derived in accordance with the principles of
publicity, evidence, and standardization for the intersection area of diseases that
are “necessary” and “feasible” to develop[1].
GKoM, which was at the center of the 30 CPG development networks, is a
support system to achieve the goal of the project on the development of the
Guideline, i.e., “improving the quality and strengthening coverage of
Korean medicine medical service through the development and dissemination of
evidence-based Guideline and establishment of an integrated clinical
information center.”
The scope of work of GKoM has a variety of spectra, focusing on
supporting the development of CPGs. It will be focused on 4 areas—a) Support for the development of Guideline; b) Support
for conducting clinical trials linked to guidelines; c) Establishment of
evidence for individual Korean medicine treatment technology; and d) Operation
of the “National Clearinghouse for Korean Medicine (NCKM)” website (see Table 1)—and the final goal is to use the results of the
activities to expand coverage in the Korean medicine area and to make decisions
on related healthcare policies.
Development system of CPGs: Example
of SIGN
Many countries have organizations and systems that govern the development of CPGs. Countries in Europe including the UK, countries in North America, Australia, and New Zealand have established policies for CPGs and developed and distributed high-quality CPGs at national or regional levels. The leading institutions in developing worldwide treatment guidelines are as follows, and guidelines development of the corresponding organization system slightly differs: the Scottish Intercollegiate Guidelines Network (SIGN), the National Institute for Health and Care Excellence (NICE), the National Agency for Accreditation and Evaluation in Health (ANAES), the US Preventive Services Task Force (USPSTF), the National Health and Medical Research Council (NHMRC), and the New Zealand Guidelines Group (NZGG). Among the examples, we introduce the guidelines development system of SIGN, which provides guidelines for the National Healthcare System (NHS) in Scotland, UK and supports decision making.
SIGN was founded in 1993 by the Scottish Academy of Medical Royal Colleges and their Facilities and is an independent organization that plays a role in developing the CPGs needed for the local National Health Service (NHS)[2],[3].
1. System of organization
As the top voting body of SIGN and a committee of 24 healthcare organizations, the SIGN Council has the authority and the responsibility with regard to the policy and guidelines development methodology carried out by SIGN. Based on the content of the Guideline Program Advisory Group, a methodology review group, it gives final reviews and decides the priorities of guidelines development and the composition of the development group (see Figure 1.)
2.
Process of selecting topics for
developing guidelines
The process of prioritizing the development of CPGs
within
the limits of limited resources is very important. SIGN releases the topic proposal
form on its website and provides an opportunity for anyone to propose the topic
of CPG development, regardless of his/her institution or organization.
In addition, organizations to help patients, volunteers, and general public—who
are non-specialists in guidelines—propose topics are operated separately, e.g., SIGN Patient Involvement Advisor, and SIGN Public Partners.
SIGN conducts an internal
review of the appropriateness of the proposals received and a scoping review on
topics deemed appropriate to
review whether there is sufficient evidence to enable the development of
evidence-based treatment guidelines. The proposers are invited to the meeting
at the final decision stage, and the final selection is strictly based on the
official priority selection criteria form. The proposed topics are released on
the SIGN website, leading to development after receiving official approval from
the SIGN Council.
3. Official consultation and peer review system
SIGN has a system wherein stakeholders and communities review the first
draft of CPGs extensively through three stages: 1) online disclosure, 2)
national open conference, and 3) peer review. Online disclosure is a process of gathering
and reflecting opinions from the general public through website disclosure. During
a national open conference, 75 to 300 experts gather to hear and discuss the rough
draft of the content of development. Lastly, peer review is carried out by
sending the draft of CPGs to two lay reviewers for review of the
accuracy of the evidence descriptions and receives advice on whether perspectives
of patients have been taken into account. The opinions and reflections of all
these processes are organized in a consultation report and submitted to the
SIGN Council for review on suitability before being certified as SIGN CPGs.
4. Management
of published guidelines
There is a systematic management system for CPGs
validated
and published by SIGN. For every guideline that is over three years old is not
revalidated, a systematic review is conducted in order to determine whether an
update is needed for each guideline. The outcome of the report will be one of
four options:
Suggestions for the a Sustainable Guideline Development
System
As an organization for the development, certification, and expansion of
the Guideline, GKoM operates a systematic certification system for guidelines
such as the Evidence-based Korean Medicine Promotion Committee as the top
voting body for the certification and dissemination of the guidelines, the Review
and Evaluation Committee, which is the methodology review group, and the
External Review Advisory Group. The Secretariat of GKoM functions as the administrative
body. In 2017, preliminary certifications were given to 30 CPGs; 9 of
them have now passed final certification process, and GKoM is taking steps
toward the goal of developing a total of 30 Guidelines.
In this article, we have compared the working body to carry out Korean
Medicine CPG development project(which is a part of state-led massive R&D
in the field of Korean Medicine) with that of SIGN, a state-led CPG development
system of Scotland. We also drew opinions on the future development
system for the Guideline to become a sustainable model.
1. Survey on
priority demand for the development of CPGs and reinforcement of selection
process
The CPG development project has the goal of developing 30 types of CPGs through pre-planning; it only supports the development of pre-planned
guidelines, and therefore, has no role in selecting priorities for the
development of CPGs by surveying on social, policy, and clinical
needs. Nonetheless, in order for steady development of CPGs
in the
future, a system is required wherein guidelines are proposed by reflecting the
needs for CPG development. Above said is a system wherein suggestions on topics
for guideline development can me made based on the needs of individuals, groups
of Korean medicine doctors or researchers, and opinions of policymakers. Furthermore,
reinforcement of GKoM's own analysis function to determine whether certain
topics can be developed into CPGs by conducting scoping review or rapid SR is
also needed.
2. Evaluation function of published guidelines
To date, GKoM has established a database (DB) for the Guideline on the
National Clearinghouse for Korean Medicine website (www.nckm.or.kr)
and has registered a total of 106 CPGs related to Korean Medicine, including 30 Guidelines,
20 other domestic CPGs, and 56 CPGs related to overseas Korean Medicine. Although
CPGs scattered sporadically are collected and shared in one
place, there is no system for determining whether the treatment guidelines
listed in the DB are still valid.
Since the time when the CPGs
need to be revised is
usually considered to be 3 years, we need our own system to determine whether
the guidelines over 3 years old are still valid, or partial update or full revision
are required through additional search and analysis. As in the example of
SIGN, withdrawal of certification should be enabled if evidence that threatens
safety is found for the intervention recommended in the current CPGs . This is because CPGs should be based on up-to-date evidence to
support decision making needed during treatment. Although the Guideline—which is
currently under development—is kept up to date with repeated revisions for 6
years, the management and evaluation functions of the certified CPGs must be listed in the regular practice guidelines development system
after GKoM.
3. Leading
the process of rapid guideline development in a situation of national crisis
such as new viral disease
Finally, the system for developing the Guideline should be able to respond flexibly to
changes in the social and policy environment. Due to new viral diseases such as COVID-19,
the Korean Medicine sector should consider system transition to a rapid
response system when guidelines are urgently needed. In super-urgent situations,
which usually require responses within one or two hours, recommendations or
systematic literature reviews of similar CPGs
are
searched; if not, recommendations are made mostly based on informal expert consensus. At the same time, however, for the
future development of evidence-based CPGs, several international organizations quickly
establish collection systems that separately provide literatures that correspond
to the evidence (e.g., https://covid-19.cochrane.org/).
GKoM operates the Korean Medicine Clinical Study DB and registers and manages Korean
Medicine-related clinical studies that are in progress or have been terminated.
In urgent situations such as COVID-19, which have social demand, however, an
emergency Korean medicine evidence collection system for epidemics should be
added separately, and the latest evidence from Korea, China, and Japan should
be uploaded so that quick guidelines can be drawn based on this. It is
necessary for the social value of clinical research DB related to Korean Medicine
or guidelines development system to prove the validity with a flexible, rapid
response.
Conclusion
The project on the development of the Guideline and its support system, GKoM,
is a time-limited system that has been implemented in the form of a national
research and development project by MOHW and which has a clear end point. The treatment
guidelines developed through this can be used as the basis for the “Clinical
Standard” of Korean medicine medical service, supporting not only decision
making at clinical sites but also the evidence-based decisions of health
policies related to Korean Medicine. If there is absence in the system that
systematically manages CPGs reflecting the latest evidence as the most
important one, however, they will be discarded one by one after 3 years, and the
CPGs for Korean Medicine will be sporadically scattered, with no choice but to
return to the blank area. If we want to utilize socially the medical service of Korean
Medicine through CPGs, it is necessary to discuss with the government and
officials to stabilize the development of the Guideline as a sustainable
support system.
<References>
1. The Society of Korean Medicine. Study on Project Planning for the
Development of Korean Medicine Clinical Practice Guideline. Ministry of Health
and Welfare (MOHW); 2016
2. Scottish Office. Clinical Resources and Audit Group. Clinical Guidelines:
Report by a Working Group. Edinburgh: Scottish Office; 1993.
3. Petrie J, Grimshaw J, and Bryson A. The Scottish Intercollegiate
Guidelines Network initiative: putting validated guidelines into local
practice. Health Bull (Edin) 1995;53:354-8.
4. Scottish Intercollegiate Guidelines Network (SIGN). A Guideline
Developer’s Handbook. Edinburgh: SIGN; 2019. (SIGN publication no. 50).
[November 2019]. Available from http://www.sign.ac.uk
[1] The Society of Korean
Medicine. Study on Project Planning for the Development of Korean Medicine Clinical
Practice Guideline. Ministry of Health and Welfare (MOHW); 2016.
[2] Scottish Office.
Clinical Resources and Audit Group. Clinical guidelines: report by a working
group.Edinburgh: Scottish Office; 1993.
[3] Petrie J., Grimshaw J.,
and Bryson A. The Scottish Intercollegiate Guidelines Network Initiative: putting
the validated guidelines into local practice. Health Bull (Edin) 1995;53:354-8.
[4] Scottish
Intercollegiate Guidelines Network (SIGN). A Guideline Developer’s Handbook.
Edinburgh: SIGN; 2019. (SIGN publication no. 50). [November 2019]. Available
from http://www.sign.ac.uk
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