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Current status of case reports and case series reported by Korean Medicine doctors in primary clinics: a systematic review

Background This study aims to review the current quantity and quality of case reports and case series published by clinical doctors who worked in local Korean medicine clinics. Methods Seven electronic databases, one in English and six in Korean, were searched for case studies authored by clinically-based Korean Medicine doctors (KMDs) and published in academic journals between January 2000 and December 2018. The following data were extracted: the number of cases per article, authorship order, types of academic journals, the number of articles published in the domestic or international academic journals by publication year, citation counts, and classification of diseases. We assessed the quality of the reports based on 28 items from the CAse REport (CARE) checklist. Results A total of 266 case reports or case series met the inclusion criteria. There were 125 articles (47.0%) in which all authors consist of who worked in Korean medicine clinics. The overall increase in the number of published articles by year showed a sharp increase after 2010. Articles were focused primarily on Korean medicine therapeutic and diagnostic approaches. The most commonly reported cases were diseases of the skin (346 or 40.9%). Overall, the quality of the reports was acceptable (75.3%) but several items such as diagnostic challenges, patient perspective, informed consent, intervention adherence and tolerability, and adverse events were substantially underreported. Conclusions To improve disease diagnosis and treatment, KMDs in clinical practice should be encouraged to report and publish case studies, using the CARE checklist to ensure quality.


Introduction
The mainstream Korean healthcare system is two-pronged: one section corresponds to conventional medicine by medical doctors; the other is Korean medicine (KM) by Korean Medicine Doctors (KMDs). KMDs are mainstream health service providers who rely on traditional East Asian therapeutic techniques such as acupuncture, moxibustion, and herbal medicines. 1 The number of licensed KMDs in 2016 was 23,460, reflecting an average annual increase of 748 KMDs since 2007. 2 Among KMDs, 65.6% (15,383) worked in local Korean medicine clinics in 2016. Korean medicine clinics are primary care facilities. Consistent with the recent increase in the number of KMDs, the number of Korean medicine clinics has increased from 10,895 in 2007 to 13,860 in 2016. 2 In 2016, 12,433,148 people were treated in Korean medicine clinics for various diseases, ranging from common colds to chronic diseases. This represents 93.6% of the total outpatients treated with KM. 3 Recently, the literature on KM has been growing in recognition of evidence-based medicine mandates, and the need to make patient-related decisions based on the best clinical research available. 4,5 Furthermore, in a nationwide online survey with KM students, respondents requested a greater emphasis on evidencebased medicine in the KM educational curriculum. 6 Although case report (CR) is considered the weakest level of evidence, it plays an essential role in establishing an evidentiary framework. CR is most often employed to inform colleagues of rare or new cases, treatments and adverse events. 7 CR can potentially capture and describe the highly individualized processes of integrative health and medicine in a way that is not possible in randomized clinical trials, where interventions must be standardized. to future research design. 8 The CAse REport (CARE) guidelines were developed to facilitate systematic reports of essential information in CR to improve the completeness and transparency. 9 The purpose of this study was to investigate the current status of case studies published in domestic and international academic journals that have been authored by KMDs who work in KM primary clinics in order to report new and interesting cases.

Types of studies
Included in this review were original case studies, (CR and CS) contributed by KMDs who practiced in Korean medical clinics. Articles were included if the clinically-based KMD was a first or contributing author. Excluded from the review were articles published by KMDs who worked exclusively in other KM settings, such as hospitals, public health centers, research institutes, or universities.

Types of participants
The subjects of the reviewed studies included pediatric and adult patients. Study selection was not limited to reports of patients with specific diseases.

Types of interventions
Important criteria in the CR and CS studies are narrative report or evidence table of demographic characteristics, symptoms, signs, diagnosis, treatment, and follow-up of an individual patient.

Data sources and searches
Seven electronic databases were searched, one in English and six in Korean: PubMed, Korea Citation Index (KCI), Korean Medical Database (KMbase), the National Assembly Library of Korea Dissertation Database, National Discovery for Science Leaders (NDSL), the Oriental Medicine Advanced Searching Integrated System (OASIS), and Research Information Sharing Service (RISS). Each database was searched for articles published from January 2000 through December 2018. The search terms consisted of three parts: "case study" (e.g., case report, case series), "Korean medicine doctor" (e.g., traditional Korean medicine doctor, oriental medicine doctor), and "Korean medicine clinic" (e.g., Korean medical clinic, oriental medicine clinic, oriental medical clinic, oriental clinic, herb clinic, haniwon, han medical clinic).

Data collection and analysis
Two independent reviewers (JHP and SYK) selected the studies according to study criteria and identified the articles to be included in the review by title and abstract. One reviewer (JHP) read the full text of the selected articles and extracted data using a standard data extraction form. Another reviewer (SYK) rechecked the data to ensure that they were obtained appropriately.

Data extraction and reporting quality
Extracted data were the number of cases per article, authorship order of KMD (first author or contributing author), types of academic journals, the number of articles published nationally or internationally by journal, and publication year. We classified the types of diseases in case reports according to the international statistical classification of disease and related health problems, 11th revision (ICD11). 10 We evaluated the quality of CR and CS reporting based on CARE guidelines, specifically the CARE explanation and elaboration document, and the Korean version of the CARE checklist. 11,12 Two independent reviewers (JHP and SYK) evaluated the quality of the case studies on the 28 items of the CARE checklist. Any disagreement between the two reviewers was resolved by discussion until consensus. A "Y" indicated there were data corresponding to the item; an "N" indicated unclear or missing data regarding the item.

Results
The electronic database search yielded 2535 potentially relevant articles and 266 studies of CR and CS were included in the review ( Fig. 1) (see supplementary online appendix 1).
KMDs published 195 articles (73.3%) as first authors. In particular, there were 125 articles (47.0%) in which the full authorship team consisted only of KMDs who worked in KM clinics. Additional authors were mainly KMD professors or researchers belonging to KM universities and hospitals. The included studies had a total of 847 cases, with an average of about 3 cases per article ranging from 1 to 38 cases. 13 Each case reported mainly Eastern and KM approaches to various chronic diseases.
The publication rate has increased sharply in recent years; there were 222 articles (83.5%) published since 2010, quadruple the number of articles published in the previous decade. Notably, there were 45 articles published in 2015 alone. Only 15 case studies with a clinic-based KMD author were published in international academic journals, and the first was in 2013 (Fig. 2).
The reviewed articles were published in 30 different academic journals: 24 domestic and six international journals. These academic journals were mainly related to KM. The most frequent publishers were the Journal of Korean Medicine Ophthalmology and Otorhinolaryngology and Dermatology with 48 articles (18.0%), and Journal of Korean Medical Association of Clinical Sanghan-Geumgwe with 39 articles (14.7%). In international journals, seven articles were published in Explore, and three were published in Complementary Therapies in Medicine (Table 1).
Of the 266 articles, 174 articles could be retrieved from KCI and Web of Science Core Collection and they were cited 485 times (mean 2.8 per article, ranging from 0 to 26 counts).
Based on ICD 11, the most commonly reported cases were diseases of the skin (346 cases; 40.9%). The primary skin diseases reported were psoriasis, acne vulgaris and scarring, seborrheic dermatitis, alopecia, and atopic dermatitis. Diseases of the genitourinary system were reported in 90 cases (10.6%) and included infertility, polycystic ovarian syndrome, and chronic prostatitis. The third most reported category was endocrine, nutritional or metabolic diseases (74 cases; 98.7%), with cases of obesity and non-insulin-dependent diabetes mellitus. No bias was found in the topics of published articles comparing all authors and authors who published more than two case study articles (Table 2). There were 19 cases (2.2%) in 9 articles reporting traditional medicine conditions, including six-meridian pattern identification/syndrome differentiation. There was one reports of adverse reactions related to medications or treatments. 14 Overall, case studies were documented consistently and in detail assessing by28 item CARE checklist (mean = 75.3%) ( Table 3). Unfortunately, there were 10 studies without the words "CR" or "CS" in the title and one study with no abstract. There are several checklist items which were not reported less than 50%. These included changes in intervention (33.8%), confirmation of informed consent (29.3%), adverse and unanticipated events (24.1%), sharing of the patient's perspective or experience (21.1%), and other items as listed in Table 3. After the CARE Guideline was published in 2013, the percentage of studies reporting informed consent increased

Discussion
We analyzed the CR and CS reported by KMD in primary clinics in quantitative and qualitative publication trends. A total of 266 CR and CS studies were published for 15 years and they included a total of 847 cases (about three cases per article). The most commonly reported cases were diseases of the skin (40.9%). Overall, the reporting quality of the reports was 75.3%.
We observed an upward trend in publication rates, with a steep increase since 2010. This quantitative increase fits with broader publication trends in medicine. The volume of CR publications increased by 45% on PubMed (from 42,439 to 61,689) and EMBASE with MEDLINE (from 49,918 to 72,388) between 2000 and 2010. 15 The most frequently published journals were the Journal of Korean Medicine Ophthalmology and Otorhinolaryngology and Dermatology with 48 articles (18.0%), and the most common cases were diseases of the skin (77 articles; 28.9%, 346 cases; 40.9%). In a recent survey on KMDs' awareness and utilization of the CR, the most frequently requested topics by KMDs in clinical practice were diseases of the musculoskeletal system, followed by diseases of the digestive system; there were no requests for cases of skin disease. 16 This response seemed related to patient visits, as the highest insurance claims at KM clinics are for musculoskeletal system disease (53.7%), according to a 2016 herbal medicine health care utilization and consumption survey. 3 However, the most common reports were about chronic and intractable skin diseases such as psoriasis, acne, atopic dermatitis, warts, and seborrheic dermatitis. It seems that KMDs reported dermatology cases more often because the outcomes are more physically apparent with the goal of informing the public and other practitioners specializing in the treatment of skin diseases. 17  Overall the quality of reporting in the CR and CS based on the CARE Checklist was generally acceptable (75.3%) and consistent with previous studies. 18,19 However, notable findings were that intervention adherence and tolerability, and expression of patient perspectives or experiences in treatment were not often reported. The case studies are most effective if they contain various clinical experiences of patients in a vivid manner. 18 Thus, case studies are more authentic and valuable if the CR and CS are written considering CARE guidelines. Doing so should improve the overall quality of CRs and ultimately may be a way to help health care providers use case study evidence more effectively in clinical and research settings. 15 KMDs in clinical practice face significant challenges to publishing case studies in international academic journals. First, clinical KMDs need a CR activation system. Such a KM educational network could help to increase both the quantity and quality of CRs through education with regard to obtaining informed consent from the patients before publication and selecting several important  clinical outcomes of major diseases of a clinic in advance using a questionnaire or medical device. Second, due to their ease of use in clinical practice and in order to enhance the clinical management of individual patients, the development of Patient Reported Outcome Measures that have been validated within the Korean population and language is required. 20 This study is limited in that it does not fully represent the quantity or quality of CR and CS reported by all KMDs, as it focused on reports from clinical KMDs, rather than those in university or hospital settings.
To produce practical clinical research and new hypotheses for disease diagnosis and treatment, case study reports by KMDs working in clinical settings should continue to be promoted and published. When promoting case reports in KM clinics, there is a need for organic cooperation in case study training between the association of KM society, various KM-related societies, and KMDs.