STandards for Reporting Interventions in Clinical Trials Of Tuina/Massage (STRICTOTM): Extending the CONSORT statement

Massage is a common therapy of nonpharmacological treatments, particularly in Tuina (Chinese massage) as its most common style, detailed guidance in reporting the intervention is warranted for its evaluation and replication. Based on the CONSORT (Consolidated Standards of Reporting Trials), we aimed to develop an Extension for Tuina/Massage, namely “The STandards for Reporting Interventions in Clinical Trials Of Tuina/Massage (STRICTOTM).”


INTRODUCTION
Massage is a complementary therapy used worldwide, which has been developed for the health and well-being of humanity throughout the ages. Originally, massage was considered a sacred system of natural healing in India, dating back to 3000 BCE. 1 The earliest record of massage was identified in the oracle bone script (the earliest known form of Chinese writing), representing a form of self-healing for ancient people. 2 The ancient Chinese further developed a medical bible called "The Yellow Emperor's Classic Book of Internal Medicine," in which massage therapy was described as an important treatment, sometimes combined with acupuncture, acupressure, and herbal remedies. 3 As culture and history evolved, the massage methods travelled to Egypt, Ancient Greece, the Roman Empire, Japan, and Sweden, etc. It was noted that Hippocrates, the "father of medicine," described medicine as "being the art of rubbing," and prescribed a combination of massage, proper diet, exercise, fresh air, and music to restore balance health. 4 Nowadays, massage therapy is defined as a systematic manipulation of soft tissues of the body for pain reduction or other therapeutic purposes. 5 There are different styles of massage around the world, including Chinese massage (called "Tuina" starting from Ming dynasty (c. 1400)), Swedish massage, Thai massage, oil massage, and aromatherapy massage, etc. 6 Among them, Tuina has been identified as the most common type of massage, which includes a wide range of technical manipulations of pulling, pressing, tapping, shaking, vibrating, kneading, rolling, gliding and acupressure, and prescribed according to the theory of traditional Chinese medicine (TCM). 7,8 In clinical practice, massage therapy has been, and continues to be, a vital part of complementary and alternative medicine (CAM) treatments. 9,10 Indeed, there is an increasing number of clinical trials on massage for different conditions, particular in the diseases of the musculoskeletal system or connective tissue, nervous system, digestive system, gynecological and pediatric diseases, even for some subhealth status with symptoms, signs or clinical findings but not be definitely diagnosed. 7,[11][12][13] More researchers and clinical practitioners are investigating the underlying mechanism(s) of the above clinical efficacy, such as why the intervention can reduce different types of pain. 14,15 The results reported that the functions of massage could be summarized as boosting blood circulation, removing blockages, realigning the musculoskeletal structure, and enhancing the body's natural healing abilities. [16][17][18] However, some scholars also have indicated that the quality of massage studies is not optimal, either in methodology or reporting. 7,19 Specifically, an overview of 8 systematic reviews (SRs) of Tuina (published during 2013-2017) was undertaken to assess the methodology and reporting quality based on AMSTAR (A MeaSurement Tool to Assess systematic Reviews) 2 and PRISMA checklists. 20 The results of this study showed that all SRs were rated as very low quality according to AMSTAR 2, while identified several reporting deficiencies in the PRISMA items (e.g., item 5, 6, and 23). Moreover, in our latest survey of 2447 randomized controlled trials (RCTs) of massage (from 1975 to 2020), we found that the average reporting compliance rates of the CONSORT (Consolidated Standards of Reporting Trials), CONSORT Extension for NPT (Nonpharmacologic Treatments), and a self-designed massage-specific checklist were only 50%, 10%, and 45%, respectively. 7 It is concluded that the overall quality of reporting was unsatisfactory, presenting lots of deficiencies for massage details, such as the rationale for choosing massage as a therapy, the details of massage techniques, and the background of treatment provider(s), which have not been covered by generic reporting guidelines (e.g., CONSORT and existed extensions). 21

METHODS
The STRICTOTM was developed according to the standard methodological procedure recommended by the EQUATOR Network. 23 The CONSORT Checklist was used as a starting point, and the framework of the CONSORT Extensions for acupuncture, moxibustion, and cupping was referred. 24 As the consensus process is the core method, each participant in this project was required to consent by accepting our email-based invitation and report the potential conflict of interest (if any) before giving their comments. The methodology process included the following six steps ( Figure 1). During the questionnaires, participants were asked to rate each item on a scale of 1 (not important) to 5 (very important), suggest new items, and provide comments (if any) for each item (e.g., reasons for why they believed the item that should or should not be extended); any items that did not reach consensus or any new items and comments summary of each item were circulated in subsequent rounds. Following each round, the score for each item was calculated with the formula of

Study registration
where N i represents the number of respondents who chose specific "i" in the scale of "1 to 5.″" Items with a score greater than or equal to 75% were included. In this calculation formula, both the consensus level and the weight of responses were considered. 28   During the meeting, the study background and progress were presented, followed by a discussion and a refinement of each item in the checklist. Through the Tencent online voting function, all 11 participants then voted anonymously about the inclusion of each item and decided on the precise wording. We present the data results to experts to further confirm that their comments were appropriately understood and considered. At the end of meeting, a checklist including 7 items and 16 subitems was formulated, which was also forwarded to all experts for finalization and signature.

Pilot test
To identify practical challenges with any of the items, we applied

Finalization of the guideline
Subsequent to the pilot study, our working group edited the STRIC-TOTM checklist, identifying for each item one or more exemplars of good reporting, and developed text explaining the rationale and discussing relevant evidence. After multiple circulation and revisions, we finalized the manuscript of this guideline and further discussed the publication and dissemination strategy.

RESULTS
The STRICTOTM checklist comprises seven items broken out into 16 subitems ( (i) "The aim of this study was to compare the efficacy and social con-

Explanation
The author(s) should provide adequate reasoning for the chosen intervention(s), including a brief description of the diagnosis, literature review, therapeutic advantage(s) of the style selected, and treatment rationale. The "rules" that were used in providing treatments should be reported, such as the mechanism of how the selected intervention(s) address the targeted disease(s) based on the theoretical basis. 36 Specifically, if the treatment (e.g., Tuina) that was selected has roots in TCM, it is recommended to specify whether the concept of TCM pattern/syndrome (also called "zheng") be included or not, the rationale for method(s) determination, and relevant TCM theories (e.g., "Pattern differentiation," "Promoting the circulation of qi and blood," and "Restoring qi to relieve an excess syndrome"). 37 In addition, if any disadvantages or limitations of the selected massage, and any prohibited application scope(s) were identified in previous reports, author(s) should provide a clear and complete summary. Literature and other sources should be cited where relevant, of which the published works (e.g., books or journal articles) are preferable. If the reference(s) not available, author(s) are encouraged to provide the information in an appendix or make it otherwise generally available (e.g., on a website).
If the studied intervention comes from a consensus, the full methodology procedure of how the consensus was reached should be reported (e.g., expert clinical panels and/or practitioner surveys).

Explanation
To reduce skin irritation or to add auxiliary effects of certain herbs, various mediums, like oil, powder, ointment, or herbal wine, are commonly adopted in massage. For example, mediums like garlic, ginger, and wine can heat up the meridians and remove cold from the body.
Cold water is also a good medium for massage since it decreases temperature like sesame oil and egg white. 50

Explanation
The duration time of massage used per area in one session should be reported. For individualized treatments, it is necessary to report the "mean ± standard deviation" or "median and range" of times across all participants. Although the duration is varied among different massage techniques, it is recommended to adopt minutes as units for the record.
Considering the safety issue in practice, it is also suggested to provide a normal range of duration for the studied intervention. If the actual duration is out of the range, author(s) should provide the rationale.
Some techniques, such as bone-setting, are not easy to use "time" for recording the duration; it is suggested to report the stopping criteria or efficacy indicator of manipulation, which helps readers to identify the duration. In clinical practice, the duration of massage is correlated to grasping Jianjing (GB21) 3 to 5 times (Fig. 2)." 63

Explanation
Other components of the intervention group commonly include additional treatments of auxiliary techniques, prescribed selftreatment and lifestyle advice provided by the practitioner, which is different from "cointerventions" or "baseline treatment" (added to both intervention and control groups). For massage-related interventions, such as herbal ointment and acupuncture, information should be provided equivalent to that recommended for the above details.
For adequate reporting of these therapies, relevant guidelines are highly recommended, such as STRICTA for acupuncture, 24 STRICTOM for moxibustion, 25 CONSORT for CHM formula, 69,70 STRICTOC for cupping. 26 If the study protocol includes the options of prescribed self-help treatments such as exercise and/or dietary changes based on massage-related diagnostic criteria, then these too must be reported. The participant's compliance with this advice should also be mentioned.

Explanation
As an external treatment, adequate communication between the treatment provider and subjects could facilitate the smooth conduction of manipulations, further improving participants' compliance. 72 Specifically, if high-strength manipulations will be adopted, it is better to inform participants before the initiation, including a detailed explanation of the manipulation purpose, expected efficacy, and possible response, either uncomfortable (e.g., sore and pain) feelings or relief-

Examples
(i) "All the adverse events (AEs) will be monitored and recorded by researchers throughout the treatment. AEs will be coded using the World Health Organization Adverse Reaction Terminology Dictionary. Skin lesions and rashes are common side effects of massage.
Once the AEs occur during the treatment, the time and severity of the treatment will be recorded in detail, the cause will be analysed, and the correlation between the AE and trial will be evaluated." 63 (ii) "Expression of worsening symptoms during the study period, such as increasing pain intensity, swelling, and bruises, in which case a referral to conventional medicine would be given." 83

Summary
Massage

Dissemination
To better disseminate the STRICTOTM guideline, we will take the following steps: First, we have registered the STRICTOTM guideline in the EQUATOR and will keep the information updated. This guideline will be available on the websites of EQUATOR Network and the Chinese EQUATOR Centre (https://www.equator-network.org/about-us/ chinese-equator-centre/). Second, through academic conferences and workshops, we will introduce this guideline to relevant clinical practitioners, researchers, peer reviewers, and journal editors. For example, we held a zoom webinar conference of the STRICTOTM introduction in the end of November 2022. All comments are encouraged to improve the checklist and keep it relevant. Simultaneously, we will prepare the translations (e.g., Chinese version) of the guideline according to the CONSORT translation policy. Third, we seek relevant journals to endorse the STRICTOTM and, if applicable, suggest Chinese journals of TCM to take measures to improve author adherence to these recommendations. 84

Strengths and limitations
The development process of the STRICTOTM was comprehensive,

CONCLUSIONS
The STRICTOTM proposes the critical set of items to be reported