key: cord-0760650-f2wb3er0
authors: Xie, Runsheng; Xia, Yun; Chen, Yaolong; Li, Hui; Shang, Hongcai; Kuang, Xinying; Xia, Linjun; Guo, Yi
title: The RIGHT Extension Statement for Traditional Chinese Medicine: Development, Recommendations, and Explanation
date: 2020-09-02
journal: Pharmacol Res
DOI: 10.1016/j.phrs.2020.105178
sha: 35d4d36fa80eea898604ec108e3a9f84336a4848
doc_id: 760650
cord_uid: f2wb3er0

Nowadays, the number of traditional Chinese medicine (TCM) guidelines is constantly increasing, but its reporting quality is still disappointing. One of the main reasons is that there is a lack of suitable reporting standard to guide it. Low-quality reports impede the presentation of the guidelines’ content even if the guidelines are well projected and developed, thereby hindering the user’s integration and evaluation of guidelines and even misleading clinical decisions [1,2]. In response to this long-standing problem, the Reporting Items for practice Guidelines in HealThcare (RIGHT) Working Group has organized a group of TCM clinical experts, methodologists, and epidemiology, through a multi-staged development process, including systematic review, reporting quality evaluation and online Delphi expert consensus, developed the RIGHT Extension Statement for TCM (RIGHT-TCM). The RIGHT-TCM extends two sections of the RIGHT Statement, includes basic information and recommendations section. Seven strong recommendation sub-items were added on the basis of RIGHT Statement and formed the RIGHT-TCM finally. The group hopes that the RIGHT-TCM can assist TCM guideline developers in reporting guidelines, support journal editors and peer reviewers when considering TCM guideline reports, and help health care practitioners understand and implement a TCM guideline. This article will introduce its background, development, recommendations and explanation as follows.

Nowadays, the number of traditional Chinese medicine (TCM) guidelines is constantly increasing, but its reporting quality is still disappointing. One of the main reasons is that there is a lack of suitable reporting standard to guide it. Low-quality reports impede the presentation of the guidelines' content even if the guidelines are well projected and developed, thereby hindering the user's integration and evaluation of guidelines and even misleading clinical decisions [1, 2] . In response to this long-standing problem, the Reporting Items for practice Guidelines in HealThcare Reporting quality is a significant part of the study of clinical guidelines. High-quality reports can fully explain the guideline development process and provide useful and clear recommendations for readers. To solve the reporting problem of guidelines, researchers from different countries studied extensively and presented relevant reporting standards. In 1993, a nine-item reporting standard was developed for the summary of clinical practice guidelines (CPGs), which is the first time to provide a template and basis for how to systematically and normatively report the information about the development and content of guidelines [3] . In 2003, the Conference on Guideline Standardization (COGS) Working Group was established to develop a reporting standard for CPGs [4] . The COGS standard consists of 18 items that cover the entire process of guideline development, but it is limited to the clinical field and has not been updated since 2003. Since the launch of Appraisal of Guidelines J o u r n a l P r e -p r o o f for Research and Evaluation II (AGREE II) in 2009, AGREE II has been widely used in the quality evaluation of guidelines [5] [6] [7] . Although it is stated in the statement that it can also be used as a reporting standard, researchers still generally use it as a quality evaluation tool. In 2016, the international RIGHT Working Group developed the RIGHT Statement as a reporting tool for practice guidelines [8] . Based on the World Health Organization guidelines and the items of the COGS and AGREE II, this international reporting tool was developed in strict accordance with existing framework and the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) network approach. Consisting of 22 items across 7 domains, the RIGHT Statement has been widely applied to clinical practice, public health and health policy guidelines [9] [10] [11] .

However, we found the RIGHT Statement checklist does not fully applicable to the traditional Chinese medicine guidelines and hard to reflect its major characteristics [12] . TCM is one of the oldest medical systems in the world and its theoretical system has unique characteristics of Chinese culture and philosophy and has accumulated rich clinical experience [13] . For example, TCM is characterized by the concept of organic wholeness and treatment based on syndrome differentiation.

Its guidelines also reflect its distinctive characteristics and Chinese traditional cultural characteristics.

These factors may be ignored in the process of developing and reporting guidelines [14] . The reporting standard of the TCM guidelines should reflect the characteristics of Chinese medicine itself.

This idea was also endorsed by the RIGHT Working Group, and a multidisciplinary expert was organized to develop the extended version.

The EQUATOR network approach was used as the methodological guidance for this research [15] , which included in the following three steps: (1) establishment of research working group, (2) systematic review of the literature and items establishment, (3) expert consensus and items selection. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) grid rules were used to reach decisions when the consensus is elusive (Additional file 4) [16, 17] . More details of material and methods is presented in Additional file 5.

Literature search and reporting quality evaluation. The diagram of the screening process is shown in Fig. 1 . After screened for potentially eligible CPGs, a total of 539 TCM CPGs were eventually included (Additional file 6). Our previous research results showed that the reporting quality of these 539 TCM CPGs was improving, but the overall quality remained suboptimal [12] .

There were some difficulties we encountered during the evaluation of the TCM guidelines when using the RIGHT Statement. For example, in the background section, TCM have their own unique historical evolution. In terms of epidemiology, there is a lack of statistics on the basic epidemiology of the health problem of TCM. In terms of recommendations, there is a lack of reporting content concerning principle-method-recipe-medicines of TCM. In terms of evidence, there is no uniform reporting standard for the quality of evidence of ancient classic theoretical Chinese medical case and famous experts experience. For these aspects, the existing RIGHT Statement items are not well applicable for TCM.

After extracting the information of these 539 TCM guidelines, the contents of 10 items were found not included in the RIGHT statement checklist. These items are reported to varying degrees in the TCM guidelines (Fig. 2) . Among of them, items 8, 9 and 10 J o u r n a l P r e -p r o o f (traditional Chinese medicine decoction, traditional Chinese patent medicine and acupuncture) are the contents often mentioned in interventions section of TCM guidelines. As shown in Fig. 3 , the specific reporting content of these three items were further analyzed. After discussion in the face-to-face meeting, the core working group determined 24 initial sub-items based on the results of Describe the acupuncture points, major points, matching points, and their addition and subtraction information. Besides, other 16 weak recommendation sub-items were not included, but these items could be served as a reference for future research (Table 1) .

The present paper describes a multi-staged development process of the RIGHT-TCM, including One of the purposes of a systematic evaluation is to reduce random errors and systematic errors as much as possible through comprehensive searches and rigorous review and to provide near-real scientific evidence for decision makers [18, 19] . We have comprehensively collected the published CPGs for TCM and tried to use existing tools for evaluation. To begin with, we evaluated the reporting quality of TCM guidelines. The results show that the reporting quality of the TCM guidelines is poor, and the existing RIGHT Statement cannot be fully suitable for the TCM guidelines. There is a requirement to develop an extension of the RIGHT Statement to reflect the unique characteristics of TCM. In addition, we conducted a comprehensive analysis of the data from the TCM guidelines and condensed the data into initial items. We also used a brainstorming method to supplement the initial items, and we supplemented new items with such discussions to prevent omissions. Moreover, we used the Delphi method and GRADE grid rules in the consensus process.

All the participating experts did not know each other, and they answered the questions raised without meeting each other and without discussion. This back-to-back anonymity has advantages and can avoid other influencing factors [20, 21] . Finally, a total of 7 strongly recommended sub-items are determined as extension items into the RIGHT-TCM.

For item 1 (S1 in the checklist of the RIGHT-TCM), it is recommended that a clinical guideline for TCM could be identified by the title. This item is useful for rapid judgment, screening and classification for the TCM guidelines. For item 6 (S2 in the checklist of the RIGHT-TCM), it is recommended to describe the principle and method of TCM treatment in the recommendations section. These general principles and basic methods for treating diseases are based on the unique concept of holism and syndrome differentiation and have guiding significance for the specific J o u r n a l P r e -p r o o f treatment measures in traditional Chinese medicine [22] . For item 7 (S3 in the checklist of the RIGHT-TCM), it is recommended to describe whether to treat disease based on the syndrome differentiation of TCM. Syndrome differentiation is an important basic concept of TCM [23] [24] [25] . It is the process of applying "principle-method-recipe-medicines" to clinical practice. For item 8 (S4 in the checklist of the RIGHT-TCM), it is recommended to provide clear and accurate description of TCM decoction in the intervention. TCM decoction refers to a method consisting of herbs with relatively specific processing methods and usage. The decoction is the main prescription of TCM, so it is necessary to make a detailed report on the TCM decoction [26, 27] . For item 8-5 (S4-1 in the checklist of the RIGHT-TCM), it is recommended to describe the administration route and frequency of TCM decoction. The administration route and frequency are also one of the ways to influence the efficacy of the medicine. The traditional administration route of TCM is mainly based on internal and external use (oral and dermatological drugs) [28, 29] . In addition, there are many administration routes such as inhalation, sublingual administration, mucosal surface administration, rectal administration [30] . Currently, only 4% and 0.3% of the guidelines describe the route and frequency of administration, respectively. For item 10 (S5 in the checklist of the RIGHT-TCM), it is recommended to provide clear and accurate description of the acupuncture in the intervention.

Acupuncture is an important component of TCM interventions. Acupuncture has been increasingly used as an integrative or complementary therapy and it is well-tolerated with little risk of serious adverse effects [31] [32] [33] [34] . For item 10-1 (S5-1in the checklist of the RIGHT-TCM), it is recommended to describe the acupuncture points, major points, matching points, and their addition and subtraction information. The acupoint is the area that the Qi in meridian flows into the body surface and is the area where the needle is stabbed [35] . With the rapid development in recent years, TCM has been widely used in different area, and its guidelines and handbooks have also played an important role in Public Health Emergency of International Concern (PHEIC) [36] . Such as part of "TCM Classification Therapy to Improve Curative Efficacy" in the "Handbook of COVID-19 Prevention and Treatment" [37] . For PHEIC, the procedures and methodological requirements of the Rapid Advice Guideline should be adopted [38] [39] [40] . However, the current RIGHT-TCM reporting items for the Rapid Advice Guideline has yet to be developed, which may be a possible research direction in the future.

Although this study reflects the scalability of the RIGHT Statement, there are some limitations need to attention. In the current study, we only study the standardized reports of the most commonly TCM interventions, such as TCM decoction, traditional Chinese patent medicine and acupuncture.

Interventions of TCM also included moxibustion, massage and cupping, etc. Therefore, we will revise the checklist in the future based on user feedback and evaluation results.

In summary, seven strong recommendation sub-items were added on the basis of RIGHT Statement and formed the RIGHT-TCM finally. We hope that the RIGHT-TCM can assist TCM guideline developers in reporting guidelines and improving the reporting quality, help the target audience understand and implement a guideline. Fig. 1 The diagram of the screening process Excluded 

Practice guidelines developed by specialty societies: the need for a critical appraisal

The scandal of poor epidemiological research

More informative abstracts of articles describing clinical practice guidelines

Standardized reporting of clinical practice guidelines: a proposal from the Conference on Guideline Standardization

AGREE II: advancing guideline development, reporting and evaluation in health care

Quality and reporting of guidelines on the diagnosis and management of dystonia

Development and Validation of a Tool to Assess the Quality of Clinical Practice Guideline Recommendations

A Reporting Tool for Practice Guidelines in Health Care: The RIGHT Statement

Reporting quality evaluation of clinical practice guidelines published in journals of mainland China in 2016

Practice guidelines on migrants' health: assessment of their quality and reporting

A quality evaluation of guidelines on five different viruses causing public health emergencies of international concern

Using the RIGHT Statement to evaluate the reporting quality of clinical practice guidelines in traditional Chinese medicine

CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration (Traditional Chinese Version)

Clinical practice guidelines in China

Guidance for developers of health research reporting guidelines

GRADE guidelines: a new series of the Journal of Clinical Epidemiology

Use of GRADE grid to reach decisions on clinical practice guidelines when consensus is elusive

Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0. The Cochrane Collaboration

David Sackett and the birth of Evidence Based Medicine: How to Practice and Teach EBM

A Delphi study to identify performance indicators for emergency medicine

Essential key messages about diagnosis, imaging, and self-care for people with low back pain: a modified Delphi study of consumer and expert opinions

A research on syndrome element differentiation based on phenomenology and mathematical method

The basic theory, diagnostic, and therapeutic system of traditional Chinese medicine and the challenges they bring to statistics

Study on TCM Syndrome Differentiation of Primary Liver Cancer Based on the Analysis of Latent Structural Model

A Large-Scale, Multi-Center Urine Biomarkers Identification of Coronary Heart Disease in TCM Syndrome Differentiation

Application evaluation of clinical practice guidelines for traditional Chinese medicine: a clinical analysis based on the analytic hierarchy process

Wendan decoction (Traditional Chinese medicine) for schizophrenia

Gut microbiota, a new frontier to understand traditional Chinese medicines

The rise of traditional Chinese medicine and its materia medica: a comparison of the frequency and safety of materials and species used in Europe and China

Inhaled insulin-intrapulmonary, intranasal, and other routes of administration: mechanisms of action

Non-pharmacological treatments for pain relief: TENS and acupuncture

Acupuncture in hospice settings: A qualitative exploration of patients' experiences

Clinical Efficacy of Acupuncture on Rheumatoid Arthritis and Associated Mechanisms: A Systemic Review

Acupuncture for Pain

Observation on clinical therapeutic effect of acupuncture treatment on functional dyspepsia based on syndrome differentiation

The clinical benefits of Chinese patent medicines

The authors wish to express their gratitude to the following people who participated in the research and consensus process of the report specification: Hao Chen (Nanjing University of Chinese 

 medicine theory.  background  section  3 Describe the basis for diagnosing the disease based on biomedical theory and/or traditional Chinese medicine theory.Weak recommendation 4 Describe the knowledge of disease pathogenesis in traditional Chinese medicine theory.Weak recommendation 5Describe the specific reasons for using traditional Chinese medicine to treat the disease.Weak recommendation 6Describe the principle and method of treatment for traditional Chinese medicine in the recommendations.

Extension of RIGHT 13a item (recommendation section) 7Describe whether to treat disease based on the syndrome differentiation of traditional Chinese medicine.

8Provide clear and accurate description of traditional Chinese medicine decoction in the intervention.

Describe the name and provenance of traditional Chinese medicine decoction.

Describe the herbal names, herbal addition and subtraction, dosage of traditional Chinese medicine decoction.Weak recommendation

Describe the composition principle, basis and interpretation of traditional Chinese medicine decoction.No recommendation

Describe the decocting method of traditional Chinese medicine decoction.Weak recommendation Describe the administration route (e.g., oral, topical), frequency of traditional Chinese medicine decoction.

Describe the duration of treatment of traditional Chinese medicine decoction.Weak recommendation 9Provide clear and accurate description of traditional Chinese patent medicine in interventions.Weak recommendation 9-1Describe the product name (e.g., the trade name), provenance and manufacturer of traditional Chinese patent medicine.No recommendation 9-2 Describe the dosage of traditional Chinese patent medicine.Weak recommendation 9-3Describe the administration route (e.g., oral, topical), frequency of traditional Chinese patent medicine.Weak recommendation 9-4Describe the duration of treatment of traditional Chinese patent medicines.Weak recommendation Provide clear and accurate description of the acupuncture in the intervention. Describe the acupuncture points, major points, matching points, and their addition and subtraction information.

10-2 Describe the specific information of the needling instrument used in the acupuncture process.Weak recommendation 10-3Describe the needling manipulation, needling depth and needling retention time of treatment required for acupuncture.Weak recommendation Describe the frequency of treatment required for acupuncture.Weak recommendation Describe the duration of treatment required for acupuncture.Weak recommendation