Visual abstract

Introduction

Case reports have been regarded as important publications which inform us of safety concerns about new and rare complications or adverse events (AEs) associated with therapeutic interventions [1]. Acupuncture is generally accepted as a safe intervention when practiced by experienced and well-trained professionals. However, the growing number of case reports on acupuncture-related AEs has raised public concern about the safety of acupuncture. A recent systematic review analyzed the publication status and reporting quality of acupuncture-related AEs from 2010 to 2023 and found an average of 12 case reports on acupuncture-related AEs per year. However, many of these reports lacked important details necessary for assessing the causal relationship between acupuncture and the reported AEs, evaluation the appropriateness of acupuncture treatments, or consideration of other contributing risk factors for AEs [2]. This incomplete reporting not only contributes to inaccurate assessments of acupuncture safety but also risks exaggeration of its potential harm, thus contributing to misinformation. In this sense, guidance for authors, intending to write case reports on acupuncture, is necessary and helpful for complete and transparent reporting.

The CAse REport (CARE) guidelines are available for use on new case reports, but it is limited to general descriptions of patients’ clinical presentations and treatment experiences. This is insufficient for case reports on acupuncture-related AEs, which have specific clinical features and factors that should be considered. Acupuncture-related AEs can be caused by defects in the acupuncture needles, negligence or malpractice on the part of the acupuncture practitioner, patient-related factors, or a combination of these factors [3]. Since the CARE guidelines do not include these items, authors may easily forget or omit this information in their case reports. This could compromise their educational value in the prevention of similar AEs occurring in acupuncture practice in the future. Developing a reporting guideline for acupuncture-related AEs is necessary not only to improve the quality and reliability of case reports but may also contribute to enhanced patient care.

A consensus-based reporting guideline refers to a systematic reporting guidance or checklist developed based on the consensus of relevant stakeholders. The EQUATOR (Enhancing the QUAlity and Transparency of Health Research) Network provides methodologies for creating reporting guidelines to promote transparent and accurate health care research publications. Following these methodologies, we aim to develop a reporting guideline specifically for case reports on acupuncture-related AEs. This article presents an overview of the protocol for the entire process of developing the reporting guideline, outlining the steps, and approaches which will be taken to ensure the guidelines’ robustness and relevance [4].

Approach

This study aimed to develop reporting guidelines through a consensus Delphi survey of experts with a checklist for essential items to be included in case reports on AEs related to acupuncture treatment. Before conducting the Delphi survey, the study protocol and survey questionnaire for all steps of the development of this reporting guideline were reviewed and approved from the institutional review board [KHSIRB-24-395 (RA)].

1. The development group of the development group

International experts on acupuncture and research methodologists participated in the reporting guideline development group. Eleven panelists from 5 different countries (Korea, China, Canada, the Netherlands, and Norway), comprising 8 experts on acupuncture and 3 methodologists, joined the development group. Details of the group members are provided in Supplementary Material 1.

2. Literature review

The results of a previously published systematic review of case reports on acupuncture-related AEs studies between 2010 and 2023 [2] were employed to assess the reporting quality of current case reports on AEs associated with acupuncture. This information was used to extract key items for inclusion in the proposed reporting guidelines.

3. Survey development

Based on the literature review [2], a preliminary Delphi questionnaire was developed. This reporting guideline was developed following the CARE guidelines and specifically focused on expanding Patient Information (Item 5), Clinical Findings (Item 6), Timeline (Item 7), and Diagnostic Assessment (Item 8) items from the CARE guidelines [1]. The questionnaire includes 3 items addressing current issues in AE reporting related to acupuncture and other items: 8 items related to information on AEs, 12 items related to acupuncture treatment which is the potential cause of the case report and 3 items concerning patient information. Apart from these, 3 additional items regarding the authors of the case report are included. Each item will be rated on a 9-point Likert scale, ranging from “Extremely unimportant” (1 point) to “Extremely essential” (9 points): “Extremely essential” is assigned a score of 9, “Very essential” a score of 8, “Essential” a score of 7, “Maybe essential” a score of 6, “Unsure unimportant or essential” a score of 5, “Maybe unimportant” a score of 4, “Unimportant” a score of 3, “Very unimportant” a score of 2 and “Extremely unimportant” a score of 1. The questionnaire was created using Google Forms, and the survey link will be distributed to experts recommended by acupuncture associations in various countries (Supplementary Material 2).

4. Delphi and consensus procedure

For the Delphi survey, an email link will be delivered to potential participants including general acupuncture practitioners, researchers of acupuncture studies, and research methodologists who are experts on case reports or reporting guidelines. To ensure representation of the opinions of acupuncture practitioners and researchers worldwide, we aim to recruit up to 200 experts which is more than the 7 to 15 survey respondents or experts which are generally necessary [5]. To ensure fair recruitment, recommendations for potential participants will be obtained from acupuncture societies in Korea, China, Japan, the US, and European countries, and the email link will be sent to every potential participant without selection.

The survey link will be sent to experts, to collect feedback for the 1^st round of the Delphi process. Participants will rate items on a 1–9 Likert scale (1 = extremely unimportant, 9 = extremely essential). The ratings will be categorized into 3 main ranges: scores of 7–9 indicate the item is essential, scores of 4–6 suggest it is preferable, and scores of 1–3 indicate it is non-essential. If 80% of respondents select either in the 1–3 range or the 7–9 range, the item will be considered to have reached consensus and will not be included in a subsequent round of the Delphi survey. A table summarizing the score distribution will be created to present the results. Based on the outcomes of the 1^st survey, items that do not reach consensus will be included in the 2^nd round of the Delphi survey. After collecting the responses, the data will be analyzed and used to inform the development of the 3^rd Delphi round, which will be conducted via an online platform such as Zoom. Items that fail to reach consensus in the 3^rd round will be excluded from the proposed case report guideline.

5. After consensus

To promote the use of this proposed reporting guideline, an explanation with elaborate documentation will be sent to high-impact acupuncture journals as well as international journals focused on research methodology and case reports. In addition, following publication, journal editors will be contacted to encourage the inclusion of this reporting guideline in their Guide to Authors. This will assist authors in adhering to standardized reporting practices. Furthermore, we will register this reporting guideline on the EQUATOR website, where authors frequently assess relevant reporting guidelines when preparing scientific papers. Beyond these strategies, this reporting guideline will be submitted for presentation at international academic conferences related to acupuncture, alternative and complementary medicine, and it will be promoted within the research community ensure a broad adoption. Following these measures, the need for updating this reporting guideline will be assessed following feedback from authors of case reports and experts involved in the editing of acupuncture case reports (Figure 1).

Discussion

The expectation of this reporting guideline is that it will benefit researchers, readers, and editors (or peer-reviewers) of case reports on acupuncture-related AEs. Anyone who wants to write case reports will be able to prepare their manuscript with the necessary items for describing the details of acupuncture which will contribute to the patient care. It will also help readers to evaluate causal relationships between the previously reported acupuncture-related AEs. Readers of articles where the guidelines are used, will also benefit from being able to check all the critical components (outlined by the guideline) to allow them to learn from these cases to prevent similar AEs in the future. In addition, complete reporting using this guideline may facilitate replication, review updates, and inclusion in overviews by researchers in this area.

When this reporting guideline has been fully developed, effort will be made to encourage its incorporation it into the author guidelines of journals that frequently publish case reports on acupuncture treatments and acupuncture-related AEs. The guideline will be introduced at conferences related to complementary and alternative medicine to serve as a reference for authors writing case reports on acupuncture-related AEs in the future.

Reporting guidelines help researchers and journal editors ensure transparency and completeness in the research publication [4]. Research waste is an emerging problem in biomedicine [6] and also in the field of acupuncture [7]. The continued publication of case reports on acupuncture may not provide novel information and improve the safety of acupuncture, but rather exaggerate biased concepts about acupuncture [2]. In this sense, a reporting guideline is necessary to promote a balanced and well-informed write up of a case report on acupuncture-related AEs in the future, and achieving this goal is the purpose of our research through this project.

Supplementary Materials

Article information

Author Contributions

Conceptualization: T-HK, Y-SL, J-WK, MSL, LA, JYN, SB, TA, LY, YD, and ZX. Methodology: JYN. Formal investigation: T-HK and Y-SL. Writing original draft: T-HK and Y-SL. Writing - review and editing: T-HK, Y-SL, J-WK, MSL, LA, JYN, SB, TA, LY, YD, and ZX.

Conflicts of Interest

There is no conflicts of interest in the authors.

Author Use of AI Tools Statement

The authors used ChatGPT (OpenAI) solely for grammar and language improvement during the revision of this manuscript. The AI tool did not contribute to the scientific content, data analysis, or interpretation. The authors take full responsibility for all content.

Funding

None.

Ethical Statement

The study protocol was reviewed and approved from the institutional review board of Kyung Hee university [KHSIRB-24-395 (RA)].

Data Availability

Figure 1

Study flow diagram.

References

• [1] Riley DS, Barber MS, Kienle GS, Aronson JK, von Schoen-Angerer T, Tugwell P, et al. CARE guidelines for case reports: explanation and elaboration document. J Clin Epidemiol 2017;89:218−35.ArticlePubMed
• [2] Kim T-H, Lee MS, Birch S, Alræk T, Norheim AJ, Kang JW. Publication status and reporting quality of case reports on acupuncture-related adverse events: a systematic reviews of case studies. Heliyon 2023;9(10):e20577. ArticlePubMedPMC
• [3] Kim T-H, Birch S, Alraek T, Lee MS. Three aspects of acupuncture-related adverse events: Issues around the reporting of acupuncture-related adverse events. Integr Med Res 2023;12(3):100980. ArticlePubMedPMC
• [4] Moher D, Schulz KF, Simera I, Altman DG. Guidance for developers of health research reporting guidelines. PLoS Med 2010;7(2):e1000217. ArticlePubMedPMC
• [5] Hasson F, Keeney S, McKenna H. Research guidelines for the Delphi survey technique. J Adv Nurs 2000;32(4):1008−15.ArticlePubMed
• [6] Glasziou P, Altman DG, Bossuyt P, Boutron I, Clarke M, Julious S, et al. Reducing waste from incomplete or unusable reports of biomedical research. Lancet 2014;383(9913):267−76.ArticlePubMed
• [7] Zhang Y-Q, Jiao R-M, Witt CM, Lao L, Liu J-P, Thabane L, et al. How to design high quality acupuncture trials—a consensus informed by evidence. BMJ 2022;376:e067476. ArticlePubMedPMC

Figure & Data

References

Citations

Citations to this article as recorded by