Introduction
The Grading of Recommendations Assessment, Development, and Evaluation (GRADE), which is a systematic approach to rate the quality of scientific evidence and to grade the strength of recommendations, was developed by 19 countries and international organizations and is based on a series of research papers [
1]. GRADE offers a method of rating the quality of evidence and grading the strength of recommendations in systematic reviews, health technology assessments, and clinical practice guidelines addressing alternative management options [
2].
In the past 10 years, with the development of evidence-based medicine (EBM) and guideline-development methodology, guidelines for traditional Chinese medicine (TCM) have been gradually established. Under the organization of the standardization committee of the China Association of Acupuncture Therapy and with reference to the GRADE approach, over 10 domestic organizations have contributed to the development of evidence-based guidelines for the clinical practice of acupuncture therapy. To date, the clinical practice of acupuncture therapy has 18 guidelines, which include treatments of herpes zoster [
3], depression [
4], migraine [
5], Bell’s palsy, post-stroke pseudobulbar palsy [
6], primary dysmenorrhea, low back pain [
7], chronic constipation, adult bronchial asthma [
8], insomnia, allergic rhinitis, simple obesity, and chronic atrophic gastritis [
9]. We have applied GRADE to the development of these guidelines and have recorded the results of these applications. We have demonstrated both the advantages and limitations of the GRADE approach in guideline development [
10,
11]. To direct more Chinese guideline developers of acupuncture and moxibustion to use GRADE correctly, we reviewed the advantages and limitations of the GRADE approach in the guideline development for acupuncture and moxibustion and propose some solutions to these limitations.
Advantages of GRADE in the guideline development for acupuncture and moxibustion
Scientific advantages of rating quality of evidence
In comparison with other tools that rate the quality of scientific evidence, GRADE specifies clearly and comprehensively the criteria for rating the quality of evidence from high to low based on different types of research. The quality of most clinical studies on acupuncture therapy is low, and the quality of randomized controlled trials is particularly poor [
12,
13]. However, controlled studies and case series studies often provide important clinical treatment information. The GRADE approach identifies three factors that can increase the quality of evidence of observational studies and may enable them to be cited as high-quality supporting evidence. The GRADEpro software permits an automatic summary of the quality of evidence upon input of specific study information. Therefore, this flexible and transparent system of quality assessment for different types of evidence is especially applicable to rate the quality of evidence in the field of acupuncture therapy.
Outcome-centric direction
The GRADE approach requires guideline developers to state in detail the significance of all the outcomes and to distinguish the critical outcomes from the important but non-critical ones. Acupuncture therapy usually has positive effects on clinical symptoms. The GRADE approach examines disease outcomes; identifies the evidence quality of each outcome; clarifies the impact of acupuncture therapy on each critical outcome and non-critical outcome; determines the effects of acupuncture therapy on clinical symptoms, TCM patterns/syndromes, quality of life, and laboratory tests and endpoints; and provides guideline information about the characteristics and advantages of acupuncture therapy. For example, the outcomes for chronic atrophic gastritis include stomach pathological manifestation, endpoint gastric cancer incidence, gastrointestinal and systemic symptoms, quality of life scale, laboratory tests, and TCM syndrome score. These outcomes can reflect the difference in acupuncture effects in different aspects. The panels of guideline assessed the evidence and developed the recommendations according to different outcomes. They recommended that compared to pathology changes and laboratory tests, acupuncture therapy is more effective in improving symptoms, quality of life, and TCM syndrome symptoms. This recommendation will help the guideline user to better understand the advantages of acupuncture therapy.
Overall progression to develop recommendations
The GRADE approach uses evidence to develop recommendations. The guideline-development group considers the overall balance of four domains that determine the strength of a recommendation: patient values and preferences, the relationship of desirable and undesirable consequences, resource use, and quality of evidence [
14]. This helps to provide clear and practical interpretations for clinicians, patients, and policymakers [
15]. This procedure embodies the EBM approach and reflects the TCM conception of individualized diagnosis and treatment. When making decisions in clinical practice, clinicians should fully consider patient values and preferences, the balance between desirable and undesirable consequences, and the medical cost-effectiveness of treatment. Acupuncture has a long history of use in China and has been extensively applied to the treatment of many diseases because of its unique characteristics as a simple and low-cost treatment. Although evidence of its efficacy for some disorders has not yet been determined, many patients and medical staff have accepted acupuncture because of its minimal side effects and lower medical costs than Western medicine and other therapies. Hence, in developing guideline recommendations, the GRADE approach highlights the advantages of acupuncture therapy in terms of the balance between desirable and undesirable consequences, resource use, and patient preferences. For example, acupuncture therapy for depression has the advantage of fewer side effects and lower costs, and it eases the symptoms of depression while also alleviating the complications as compared to antidepressant drugs. However, patients with depression need to be treated for many sessions. The panels developed recommendations based on a comprehensive consideration.
Strength of recommendations providing specific clinical guidance
The GRADE approach classifies the strength of a recommendation as strong or weak. The classification of recommendation strength has specific implications for patients, clinicians, and policymakers [
16]. A strong recommendation implies that most patients would want the recommended treatment and only a small proportion would not and that clinicians should provide most patients with the recommended treatment. For policymakers, a strong recommendation can be adopted as a policy in most situations. A weak recommendation implies that most patients would want the recommended treatment, but many would not. Clinicians should recognize that different choices are appropriate for different patients and that each patient must be helped to arrive at a management decision consistent with her or his values and preferences. For policymakers, a weak recommendation will require substantial debate and the involvement of many stakeholders [
17]. Recommendation strength is based on general applicability and consensus. Interventions with high general applicability and consensus will be given strong recommendations, and interventions with low general applicability and consensus will be given weak recommendations [
15]. This simple grading method of recommendation strength provides a clear and specific guide to the use of recommendations in clinical practice.
GRADE limitations and solutions in the guideline development for acupuncture and moxibustion
Rating the quality of evidence for ancient literature and literature on famous TCM experts’ experiences
Most effective acupuncture therapies are formed by continuous treatment optimization through long-term practice. Ancient literature and literature on famous TCM experts’ experiences provide very important information on clinical differentiation and treatment and contribute to the evidence that informs guideline development. A combination of ancient literature, expert experiences, and modern literature forms the body of evidence that supports the recommendations.
The GRADE approach rates the quality of evidence and weighs the strength of recommendations based on modern medicine. It uses a quality assessment only of modern literature to develop criteria for rating the quality of evidence and weighing the strength of recommendations. Hence, this approach is limited for rating the quality of ancient literature and literature on famous TCM experts’ experiences. For example, strong stimulation in the treatment of acute low back pain on distal acupoints was recorded in much ancient literature and literature on famous TCM experts’ experiences. Given that the therapy has been widely used in clinical practice, little research on the evaluation of the efficacy of this therapy exists. High-quality modern literature evidence is lacking in this area. Thus, to make a recommendation about the therapy is difficult for the guideline panels.
We suggest that the guideline development of clinical practice with acupuncture and moxibustion should initially develop the scope and strategy of retrieval to incorporate ancient literature and literature on expert experience. Retrieval should include bibliographies of both ancient and modern medical texts as well as criteria based on definitions by both ancient and modern medical scholars. Differences in ancient and modern disease terms should be considered, and an attempt should be made to identify corresponding terms of targeted diseases as much as possible.
Additionally, specific criteria should be developed on the quality of ancient literature and literature on expert experience to enable their assessment. The criteria should be developed by experts on acupuncture philology based on the characteristics of acupuncture therapy and the clinical aspects of diseases. This will help to construct an integrated body of evidence that includes indexes of efficacy assessment for modern literature, ancient literature, and literature on expert experience [
19]. This will establish a comprehensive academic resource that encompasses ancient literature, literature on famous TCM experts’ experiences, and clinical verification studies, which can provide more integrated evidence to support the recommendations in the guidelines [
20,
21].
Specific guidelines of formulating recommendations from evidence
Although GRADE was developed as a method of formulating recommendations from evidence, further clarification of this progression in the guideline development of clinical practice with acupuncture and moxibustion is still needed. Precise calculation and comparison of the resource consumption in acupuncture therapies among different regions of the country is difficult because of cost variation, frequency, and treatment duration. Regarding the relationship between desirable and undesirable consequences, the routine intervention of acupuncture and moxibustion is much safer than medication (except for some special acupuncture and moxibustion therapies). Hence, the balance of desirable and undesirable consequences is not a prominent issue for this therapy. However, patients’ values and preferences may be affected by factors, such as the history of acupuncture treatment, educational background, intervention stimulation, duration of treatment, and characteristics of disease. Particularly, when patients have a strong preference, therapies that show unclear efficacy must be recommended very carefully. The published guidelines of clinical practice with acupuncture therapy indicate that the quality of evidence is not very satisfactory. Most evidence is rated as low or very low, and only a few studies are rated as showing moderate evidence. The development of recommendations with different strengths based on different levels of evidence requires more details about specific aspects of the process, such as the composition and organization model of expert meetings, the role of information provided by a guideline-development group, the voting method and procedure for recommendations, the method for calculating resource consumption, and the assessment of patients’ values and preferences. This will help to ensure a high-quality guideline development.
Summary
To ensure that feasible high-quality scientific guidelines are developed for clinical practice with acupuncture and moxibustion based on the GRADE approach, the characteristics of acupuncture and moxibustion treatment and evidence from current studies need to be considered. In addition, a focus on clinical questions and the clinical advantages of acupuncture therapy is needed [
22]. GRADE is the general tool for the development of guidelines internationally. However, GRADE has both advantages and disadvantages in the guideline development of clinical practice with acupuncture and moxibustion. Hence, we suggest that methodology experts must work toward a method that facilitates the development of high-quality clinical practice guidelines in the field of Chinese medicine and acupuncture based on the GRADE approach.
Beyond that, to use GRADE correctly and scientifically, we suggest that all members of a guideline-development group should participate in the training course for the GRADE approach and methodology of EBM so that they can master the principles and methods of literature quality assessment and how to use GRADE software. Methodologists should participate in the establishment of evidence-based clinical practice guidelines, especially experts with professional knowledge about GRADE who are responsible for quality control during the development of clinical practice guidelines. In addition, to develop recommendations from evidence during the process of developing guidelines is difficult. Methodologists and clinical experts should be involved together to disuse and formulate the recommendations of guidelines.
The use of the GRADE approach to develop guidelines for acupuncture and moxibustion has just started in China. We need to improve the methods and control the quality of guidelines of acupuncture and moxibustion in the future.
Higher Education Press and Springer-Verlag Berlin Heidelberg
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