For Clinicians: Chinese Herbal Medicine Case Report Guidelines (CHM-CARE)
By Brigitte Linder AdvDip TCM, MRes, Guoyan (Emily) Yang PhD, MMed, and Associate Professor Mike Armour, PhD
Brigitte Linder has been practicing acupuncture and Chinese herbal medicine for the past 20 years. She immigrated to Australia from Switzerland in 2008 and has been running a national herbal dispensary service in Victoria since then. Brigitte has looked after many patients with various health challenges in her local community. In addition to being a mentor and author, she is also interested in exploring how Traditional East Asian Medicine (TEAM) practitioners can use structured case reports to enhance their practice and increase their publications in Chinese herbal medicine and indexed journals. |
Dr. Guoyan (Emily) Yang is a Research Support Program Fellow in Healthy Ageing at NICM Health Research Institute, Western Sydney University. Her research focuses on evaluating complementary and integrative medicine interventions, particularly Tai Chi, Chinese herbal medicine, and acupuncture, in the prevention and management of chronic diseases, such as cardiovascular diseases and mild cognitive impairment. Her expertise includes clinical trials, systematic reviews, mixed methods, qualitative studies, and reporting guidelines. She has published over 70 research papers in peer-reviewed journals (Google Scholar total citations: 2535, h-index: 28), and has been invited to present her research findings in many domestic and international conferences. Dr. Yang is also a Tai Chi instructor with over 17-year experience, co-founder of the Boyuan Tai Chi for Health Association, and leads a weekly class at the Next Practice Western Sydney Integrative Health clinic, Western Sydney University. |
Associate Professor Mike Armour is an experienced traditional Chinese medicine (TCM) practitioner with a specific focus on endometriosis and pelvic pain. He uses a range of modalities including acupuncture, herbal medicine, and TCM based dietary and lifestyle advice to help reduce pain and other symptoms including bloating, fatigue, headaches, dysmenorrhea (period pain) and pelvic pain. Mike is an Associate Professor in reproductive health at NICM Health Research Institute, Western Sydney University where he is currently running several clinical trials on endometriosis, menstrual health, and complementary medicine. Mike has published over 85 peer reviewed articles on various aspects of women’s health including medicinal cannabis and both western and Chinese herbal medicine. |
Summary
Case reports and case report series (several case reports) capture detailed and comprehensive information about an individual patient receiving a specific healthcare service. If the data in case reports are captured systematically, they provide valuable information, particularly for Traditional East Asian Medicine (TEAM) clinicians. In TEAM, case reports have a long history and continue to play an integral part in expanding clinical skills.
Despite case reports ranking lower on the evidence-based research pyramid, case reports have become more prevalent across many fields of medicine. In 1995, the prestigious Lancet Journal introduced a case report section, and case report publications have experienced a significant resurgence since then. One reason could be that general medicine and psychology may have begun focusing on patients in the late 1990s (Bradbury et al., 2020).
The Chinese Herbal Medicine Case Report (CHM-CARE) guidelines include a checklist with 61 sub-items across 16 sections to assist TEAM practitioners in generating a structured case report. Each item describes the information that needs to be placed in each section. We created new guidelines because the existing Case Report Guidelines (CARE) (Care Guidelines 2012 - 2014) did not accommodate all the requirements of a complex TEAM modality. One such complexity is that TEAM interventions can hold evolving diagnostic processes; thus, the prescribed herbs might change multiple times during treatment. Also, a detailed section to capture self-care advice routinely given to patients by TEAM practitioners was missing in the CARE guidelines. The higher number of checklist items in the CHM-CARE was to assist inexperienced TEAM practitioners in creating a structured and comprehensive case report.
Putting the patient at centre stage comes naturally to all TEAM clinicians; hence, writing case reports should be simple, too, as long as there is guidance as to what information needs to be provided for a case report to have salient information.
The co-designed CHM-CARE guidelines and checklist came out of a graduate research degree at Western Sydney University in Australia, the goal of which was to inspire more TEAM clinicians to participate in research activities and produce structured case reports.
The CHM-CARE guidelines project
Background: Chinese Herbal Medicine (CHM) is a popular complementary medicine (CM) modality. Previous research has established that randomized controlled trials (RCTs) are suboptimal to investigate complex interventions as the customization of treatment poses a significant challenge in the typical RCT design (Padarini et al., 2020). In addition, TEAM clinicians are reporting considerable barriers in translating RCT results into clinical practice (Armour et al., 2021). Current guidelines such as CARE and Case Report in Chinese Medicine (CARC) (Fu et al., 2016) do not accommodate the practice settings of most western TEAM practitioners. The CHM-CARE aimed to co-design guidelines for CHM practitioners who operate in private clinics or outpatient settings.
Method: This project used a two-phased, mixed-method approach based on an exploratory sequential design. Focus groups with 18 participants (at least 18 years of age and qualified in CHM at Diploma Level or higher) and registered with a professional association with primary practices in Australia, New Zealand, the UK, or the US were held to investigate essential components and attitudes towards case reports. A Delphi survey was then conducted after the content analysis of Phase One, and current sources of case report guidelines were considered. Fifteen international TEAM experts participated to refine the checklist further. Those experts had 5+ years of clinical TEAM experience with either holding a higher degree, a current academic appointment, previous experience in case report writing and/or publishing or being an editor or contributor to an editorial board of a journal for case TEAM case reports. The consensus for each item was defined as reached at > 70%.
Results: From the 18 focus group participants with a median age of 50.7 years, the content analysis produced 349 codes, which informed a checklist with 98 subitems that were subsequently used in the first round of the Delphi survey. The 15 international panelists rated 37 items below the median of 3. For the second round, 14 experts achieved consensus on 61 items.
Conclusion: Consensus was reached on critical elements of the CHM-CARE checklist and guidelines. To facilitate and enhance the reporting of CHM case reports and encourage the growth of clinician-researchers, we expect that the co-designed case report guidelines will inspire TEAM practitioners to adopt the practice of case report compilation and publication.
Similarities and differences to the Case Report (CARE) guidelines used in biomedicine
The CHM-CARE guidelines were developed with the CARE guidelines in mind. The principal sections are comparable, but the CHM-CARE guidelines have three more sections and a higher number of items. The additional sections were Advice and precautions, a separate References section, and a Nomenclature and terminology section. We anticipated that TEAM clinicians might have less experience with compiling structured case reports for publishing. Consequently, we provided more prompts for the information required in each section of the case report. The main difference to the CARE guidelines is the provision to accommodate TEAM language and the use of various TEAM frameworks.
Case report layout (CHM-CARE checklist)
Topic | Item | Checklist item description | Details and example |
Title | 1 | Include the phrase “case study" or “case report," the TEAM modality, and, if relevant, the biomedical diagnosis. | Case report: The treatment of stroke with Chinese herbal medicine |
Abstract | 2a | Main lessons learnt | The Abstract should not exceed 250 words and briefly describe items a – e. This information should cover the background and context of this case. For example, the main takeaway message could be what you learnt from this case and how the unique features help understand a diagnosis, a treatment modality, a rationale, or the outcomes in more detail. |
2b | Main diagnoses and therapeutic interventions | ||
2c | Main symptoms and important clinical findings | ||
2d | Rationale | ||
2e | Outcomes | ||
Keywords | 3 | Three to five keywords should include the phrase “case report," modality and the biomedical name | Examples of keywords: “case report," “Chinese herbal medicine," “Traditional East Asian herbal medicine," “stroke" |
Introduction | 4a | An explanation of the case's importance | This section should be concise, be two paragraphs or less long and include items a – c with as many pertinent details as possible. If other researchers are quoted, it must include relevant references. |
4b | A brief description of the pathology, including common presentations and disease progression | ||
4c | Information about general incidence/prevalence and aetiology | ||
Patient information & case presentation | 5a | Chief complaint(s) | This section should include items a – h with as many relevant details as possible. |
5b | A brief description of the pathology, including common presentations and disease progression | ||
5c | Patient age | ||
5d | Sex and/or gender identity | ||
5e | Relevant social, economic, and environmental context | ||
5f | Allergies and sensitivities if relevant | ||
5g | History of the present illness | ||
5h | Past medical history (including other interventions and their outcomes) | ||
Clinical findings & physical examination | 6a | Describe the main complaint | This section should include items a – g. All your clinical findings and any insights from your physical examination (channels, abdominal, pulse, etc.) should be reported. |
6b | List all TEAM symptoms and signs | ||
6c | Describe the characteristics of the tongue. | ||
6d | Describe the characteristics of the pulse. | ||
6e | Include the results of radiographic, laboratory, or orthopaedic testing. | ||
6f | Describe any other palpatory findings such as channels, abdomen, etc. | ||
6g | Include physical observations, including skin, etc. | ||
Diagnostic assessment | 7a | TEAM diagnosis, e.g., Spleen qi deficiency, etc. | This section should give pertinent information on the diagnosis and include the therapeutic intent and the specific framework used. For TEAM diagnoses, details should consist of aetiology and diagnostic rationale, i.e., clinical judgment. |
7b | Biomedical diagnosis, e.g., irritable bowel syndrome, etc. | ||
7c | Therapeutic intent, e.g., return of period, ability to walk to work without pain, having daily bowel motions, etc. | ||
7d | Theoretical framework, e.g., eight principles theory, five elements, six conformations, three levels, Kampo, etc. | ||
Therapeutic interventions | 8a | Product or formula name | In this section, items a – e should be included for CHM interventions. For additional acupuncture interventions, the point names must be listed. In case of any other interventions used in conjunction with CHM, they must also be noted. |
8b | Single herb ingredients | ||
8c | Dosing of the herbs | ||
8d | Treatment course | ||
8e | Administration of the herbs If acupuncture is used in conjunction with herbal treatment: Point names using WHO terminology, e.g., SP6, etc., should be used If any other therapeutic interventions are used, they should always be reported | ||
Follow-up & assessment | 9a | Self-assessed clinician outcomes, e.g., periods have become regular, etc. | In this section, items a – f covering follow-up assessments should be listed. |
9b | Follow-up diagnostic or other test results | ||
9c | Intervention adherence, e.g., is the patient taking the herbs as prescribed, following the diet and lifestyle advice, etc. | ||
9d | Any adverse effects occurring during the treatment course (reporting in this section as opposed to another section) | ||
9e | Intervention tolerability, e.g., has the patient complained of bad taste, nausea or similar, etc. | ||
9f | Objective clinician outcomes, e.g., Hamilton depression scale (HDS or HAMD), blood tests, etc. | ||
Advice and precautions | 10a | Based on the TEAM framework | In this section, we would like you to report any diet, lifestyle, or other advice given to the patient. Again, they can be within the TEAM or any other framework. |
10b | Based on any other framework | ||
Discussion | 11a | A 'take away' conclusion/lesson in one paragraph | In this section, items a – e should be included. |
11b | Strengths and limitations of your approach in this case | ||
11c | The TEAM-relevant rationale for your outcomes and conclusions | ||
11d | Significances and difficulties for the diagnosis or treatment in this case | ||
11e | How this case might inform practice guidelines | ||
Patient perspective | 12 | A patient perspective of 1 - 2 paragraphs (in their own words) should be included. | One to two paragraphs in narrative format should be included from the patient in this section. |
References | 13 | Detailed reference list | This section should include a detailed reference list (for example, if you refer to conclusions discussed elsewhere). If referring to medical literature, details of sources used need to be provided as they acknowledge the work of other authors. |
Nomenclature & Terminology | 14a | To report the Chinese names (e.g., Bai Zhu) of the herbal ingredients | Please use Chinese pinyin or Kampo names to report the herbal intervention. If available, use biomedical terminology (especially if the patient has a biomedical diagnosis such as stroke). The WHO list containing standard terminology should be used to standardize the language. |
14b | To include biomedical terminology | ||
14c | to use AEMA/TEAM language designed in the “WHO international standard terminologies on TCM" list (Choi et al, 2010) | ||
Patient consent | 15 | Obtained consent from the patient. | The patient must provide informed consent for the publishing of their case report. |
Supplementary material | 16 | Provide photos, tables, and figures. | Please provide good-quality materials that are relevant to the case report presentation. |
Conclusion
The international CHM-CARE guidelines team and the editorial board at Convergent Points urge clinicians to adopt the checklist and guidelines for Chinese herbal medicine (CHM) case reports and publications. In addition to communicating findings of note to fellow practitioners and the broader medical community, and learning a great deal in the process, writing case reports to the CARE-CHM standards contributes to a repository of data that can be beneficially used in synthesis and trend analysis. Secondary data analysis, the process of discovering patterns in large datasets, could be valuable to uncover patterns that may assist our patients and advance practice-based research. At the same time, whilst discussions with TEAM practitioners revealed there is suspicion towards “evidence-based knowledge" (Robinson et al., 2012), and there exists a dichotomy between TEAM clinicians and researchers, compiling and reading structured case reports could be a means to help close that gap and use the strengths of each for the benefit of the whole profession.
References
Armour, M., et al. (2021). The Role of Research in Guiding Treatment for Women’s Health: A Qualitative Study of Traditional Chinese Medicine Acupuncturists. International Journal of Environmental Research and Public Health, 18(2), 834.
Bradbury, J., Avila, C., & Grace, S. (2020). Practice-Based Research in Complementary Medicine: Could N-of-1 Trials Become the New Gold Standard? Healthcare, 8(1), 15. https://doi.org/10.3390/healthcare8010015
Care Development Group. (2014). CARE Guidelines.
https://www.care-statement.org/
Choi, S. H., & Chang, I. M. (2010). A Milestone in Codifying the Wisdom of Traditional Oriental Medicine: TCM, Kampo, TKM, TVM-WHO International Standard Terminologies on Traditional Medicine in the Western Pacific Region. Evidence-Based Complementary and Alternative Medicine, 7(3), 303–305. https://doi.org/10.1093/ecam/nen083
Fu, S.-f., Cheng, C.-w., Zhang, L., et al. (2016). Consensus-based recommendations for case report in Chinese medicine (CARC). Chinese Journal of Integrative Medicine, 22(1), 73-79. https://doi.org/10.1007/s11655-015-2121-6
Paparini, S., et al. (2020). Case study research for better evaluations of complex interventions: Rationale and challenges. BMC Medicine, 18(1), 301.
Robinson, N., et al. (2012). Exploring practice characteristics and research priorities of practitioners of traditional acupuncture in China and the EU—A survey. Journal of Ethnopharmacology, 140(3), 604-613.
Citation: Linder, Brigitte. (2023). For Clinicians: Chinese Herbal Medicine Case Report Guidelines (CHM-CARE). Convergent Points, 2(2). www.convergentpoints.com Editor: Kathleen Lumiere, Bastyr University, UNITED STATES Received: September 28, 2023 Accepted: October 11, 2023 Published: October 15, 2023 Copyright: © 2023 Taylor. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Data Availability Statement: All relevant data are within the paper and its supporting information files. Funding: This article received no funding of any type. Competing interests: The author has declared that no competing interests exist. |