Individualized acupuncture treatment has been practiced for pain therapy. This study used acupuncture treatment for lateral elbow pain (LEP) as an example to study the diagnostic practice of individualized acupuncture treatment. A provisional version of LEP pattern questionnaire was developed based on a recent systematic review on TCM pattern diagnosis for LEP. A Delphi panel of 33 clinical experts from seven different countries was formed, and the Delphi survey was conducted in Chinese and English language for two rounds. Consensus was achieved from all 26 panelists who responded to the second round on 243 items of the instrument, which included a 72-question-long questionnaire. The mean level of expert consensus on the items of the final questionnaire was 85%. Consensus was found on four TCM patterns that could underlie LEP, namely, the
Personalized medicine has become the new trend in modern medical care [
Tennis elbow or lateral elbow pain (LEP) is a common musculoskeletal pain condition with a prevalence of at least 1–3%. Incidence rates increase up to 10% for people between 40 and 50 years of age and symptoms are often prevailing for 1.5–2 years, therefore causing considerable loss of life quality for sufferers as well as accounting for substantial economic loss [
In a previous systematic review, we have identified major TCM patterns associated with LEP. In this Delphi study, we wanted to investigate whether there is agreement between the literature and actual clinical practice. The overall aim of this study was to develop a practical instrument that will facilitate acupuncture practitioners with an easily applicable questionnaire to readily assess the underlying TCM pattern of LEP. We planned to achieve this aim through the following processes: first, we wanted to generate an initial questionnaire based on a systematic review and discussions within the research team. This preliminary questionnaire would then be presented to a Delphi panel and would undergo a Delphi survey with the following primary objectives: (1) to find consensus on which TCM patterns are the most common patterns underlying LEP; (2) to design and validate a questionnaire that would help diagnose a TCM pattern for LEP; and (3) to generate and find consensus on a list of signs and symptoms that would be indicative of one of the TCM patterns. We also used this survey to gather information for a basic list of recommended acupuncture and moxibustion treatment modalities for each pattern, as the ultimate purpose of pattern diagnosis is to guide clinical practice. This list of acupuncture/moxibustion treatment recommendations for LEP may serve as the basis for future studies.
A research team, consisting of all the authors, was formed to conduct the Delphi study. The team met regularly to initially determine the aim of the pattern questionnaire and then to generate its items, to define appropriate criteria for the selection of the Delphi expert panel, to analyze and discuss quantitative and qualitative answers after both rounds, to provide appropriate feedback to the expert panel after each round, and to monitor the progress of the study.
Before the commencement of this study, ethical approval was obtained from the Committee on the Use of Human and Animal Subjects in Teaching and Research at the Hong Kong Baptist University, Hong Kong (reference number HASC/Student/12-13/007). Purposive sampling was used for the selection of experts. Experts were chosen with the purpose that they have knowledge and experience about acupuncture treatment for LEP, with an assumption that their knowledge about LEP signs can be used to readily determine the items in our questionnaire. We aimed to identify panelists who have a broad range of knowledge in the treatment of LEP with acupuncture and ideally previous experience of having undertaken or currently undertaking clinical research on acupuncture, including RCTs. To qualify as panelists, possible candidates were screened before entering the study for a minimum acupuncture experience of five years, had to be frequently treating LEP with acupuncture, and had to be regularly using pattern diagnosis in their clinical practice. Candidates were also asked if they had previous experience with acupuncture clinical research. Recommendations from candidates meeting these criteria for inviting additional potential panelists were taken into consideration.
National and international experts were recruited from disciplines involved in the diagnosis and treatment of LEP with acupuncture including acupuncture practitioners, acupuncture researcher, and acupuncture educators.
Prospective panelists were sent an information package via email or mail to inform them of the study goals as well as the format of a Delphi study prior to sending out the questionnaires. Immediately after the prospective panelist had agreed to participate in the study, the initial questionnaire was sent to the panelist.
Names of participating panelists are mentioned in the Acknowledgments unless they indicated otherwise. The identity of the expert panelists was disclosed to the participants before the publication of this study.
In order to generate an initial questionnaire which was presented to the expert panelists in round 1 of the Delphi survey, information was compiled from the following sources by the research team: (a) a systematic review on TCM pattern diagnosis for LEP [
Findings from these sources were collected and reviewed. The research team removed nonrelevant items and composed a preliminary questionnaire, which was divided into four sections: the 1st section stated initial possible TCM patterns that could underlie LEP. In the 2nd section, signs and symptoms, which could be clinically relevant to determine the pattern underlying LEP, were reformulated into colloquial Yes/No questions that a practitioner could address to a patient. This list of questions was divided into (i) symptoms at the local elbow area, (ii) other symptoms, and (iii) physical signs. Other symptoms were subdivided into body/limbs, digestive/stools, mind, upper body, physical signs, tongue features, and pulse features. In the 3rd section, the expert needed to decide which sign or symptom would be indicative of which pattern. And, finally, in the 4th and final section of the questionnaire the expert was asked which acupuncture/moxibustion treatment modality he or she would recommend for each pattern.
In Sections
The Delphi method is a structured process in which consensus of opinions from a group of experts is obtained using a series of questionnaires in quasi-anonymity and with controlled opinion feedback [
In this first round, the panelists were to decide whether or not to retain an item for the final questionnaire as well as to suggest new items (i.e., a pattern, a sign or symptom, or a treatment modality that was not a default option), as previously described.
Based on the results of round 1, all items with a CVI ≥ 0.51, as well as all potential new items, were presented to the experts. If an expert suggested including an additional item, it was evaluated for relevance by the research team and if it was deemed relevant, it was included in round 2. The expert panel was informed of the following: “For any item of the questionnaire to appear in round 2 at least 51% (‘the majority’) of all experts had to decide to include it.” In the light of this information, the expert panel rerated all items of the four sections and was asked to either agree or disagree to retain an item for the final instrument. Experts were also informed that the second round was the final round of the Delphi survey. The final instrument would then only contain items, which consensus was reached upon after two rounds of the Delphi process.
Data was collected and analyzed by Marcus Gadau and independently reviewed by Shi-Ping Zhang and Wing-Fai Yeung. Statistical analysis was performed using the Statistical Package for the Social Sciences (SPSS) version 21.
Figure
Profile of Delphi experts.
Characteristics ( |
|
---|---|
Gender | |
|
15 |
|
9 |
Acupuncture experience | |
|
14 |
|
6 |
|
5 |
Region | |
|
11 |
|
12 |
|
2 |
Profession (multiple responses allowed) | |
|
23 |
|
13 |
|
17 |
Flowchart of Delphi process.
Of the original 679 items provided in the provisional questionnaire, 244 items (35.9%) remained after round 1 (Figure
One additional item was added after round 1 in Section
Patterns associated with LEP.
Item | Chinese name | Experts that agree % ( |
---|---|---|
( |
|
100 |
( |
湿热内 |
77 |
( |
气血两 |
87 |
( |
气滞血瘀证 | 100 |
Final LEP pattern differentiation questionnaire.
Item | Experts agree % ( |
---|---|
Local symptoms: | |
( |
88 |
( |
92 |
( |
100 |
( |
80 |
( |
80 |
( |
96 |
( |
92 |
( |
78 |
( |
71 |
( |
100 |
( |
88 |
( |
100 |
( |
88 |
( |
84 |
( |
100 |
( |
100 |
|
92 |
|
100 |
|
96 |
|
88 |
|
88 |
( |
100 |
|
96 |
|
100 |
|
100 |
( |
96 |
|
95 |
|
95 |
|
96 |
|
95 |
( |
100 |
|
100 |
|
100 |
( |
100 |
|
100 |
|
100 |
|
100 |
( |
100 |
|
100 |
|
100 |
( |
100 |
|
95 |
|
96 |
|
100 |
|
100 |
|
|
Systemic symptoms: | |
( |
92 |
( |
88 |
( |
67 |
( |
74 |
( |
78 |
( |
80 |
( |
67 |
( |
75 |
( |
76 |
( |
80 |
( |
58 |
( |
54 |
( |
68 |
( |
61 |
( |
57 |
( |
63 |
( |
67 |
( |
67 |
( |
67 |
( |
63 |
( |
71 |
( |
63 |
( |
52 |
( |
79 |
( |
74 |
( |
78 |
( |
70 |
( |
83 |
( |
70 |
( |
67 |
( |
61 |
( |
55 |
( |
61 |
( |
65 |
( |
70 |
|
|
Physical signs: | |
( |
96 |
( |
92 |
( |
92 |
( |
87 |
( |
73 |
( |
74 |
( |
74 |
( |
70 |
( |
83 |
( |
65 |
( |
74 |
( |
65 |
( |
74 |
|
|
Tongue and pulse features: | |
( |
91 |
|
86 |
|
76 |
|
78 |
|
77 |
|
78 |
|
76 |
|
86 |
|
87 |
|
77 |
( |
92 |
|
91 |
|
82 |
|
77 |
|
91 |
|
86 |
|
82 |
|
87 |
One expert suggested adding fire needling and another expert suggested adding distal needling acupuncture (DNA) as a recommended treatment modality to Section
Other experts suggested adding tuina-massage, herbal therapy (internal and external), electromagnetic stimulus, or osteopathic therapy as recommended treatment modalities. We did not include these as the spectrum of relevant therapies for the questionnaire was preset to acupuncture practice, which must involve the use of acupoint stimulation, such as acupuncture, moxibustion, acupressure, acupotomy (scalpel therapy), auricular acupuncture, or acupressure.
Expert consensus was found on 243 of 244 items from round 1 (all four sections combined). A consensus was achieved from all 26 panelists who responded to the second round on all four TCM patterns in Section
The following question from Section
The final instrument that derived from a systematic review, textbook-research, and finally a two-round Delphi process was generated. It has a list of four common patterns underlying LEP (Table
Patterns and their indicating signs and symptoms.
Item | Experts agree % ( |
---|---|
|
|
( |
100 |
( |
100 |
( |
96 |
( |
96 |
( |
83 |
( |
63 |
( |
79 |
( |
75 |
( |
68 |
( |
87 |
( |
88 |
( |
96 |
( |
88 |
( |
92 |
( |
79 |
( |
72 |
( |
80 |
( |
88 |
( |
76 |
( |
92 |
( |
79 |
( |
68 |
( |
71 |
( |
68 |
( |
79 |
( |
82 |
( |
96 |
( |
91 |
( |
96 |
( |
86 |
( |
83 |
|
|
|
|
( |
100 |
( |
86 |
( |
91 |
( |
52 |
( |
82 |
( |
91 |
( |
86 |
( |
100 |
( |
82 |
( |
95 |
( |
86 |
( |
90 |
( |
95 |
( |
91 |
( |
82 |
( |
65 |
( |
57 |
( |
71 |
( |
76 |
( |
95 |
( |
91 |
( |
77 |
( |
86 |
( |
91 |
( |
91 |
( |
67 |
|
|
|
|
( |
90 |
( |
95 |
( |
90 |
( |
86 |
( |
90 |
( |
95 |
( |
90 |
( |
95 |
( |
81 |
( |
95 |
( |
95 |
( |
86 |
( |
81 |
( |
70 |
( |
81 |
( |
81 |
( |
70 |
( |
75 |
( |
86 |
( |
60 |
( |
81 |
( |
90 |
( |
80 |
( |
95 |
( |
86 |
( |
90 |
( |
95 |
( |
75 |
( |
95 |
|
|
|
|
( |
96 |
( |
83 |
( |
100 |
( |
77 |
( |
87 |
( |
100 |
( |
73 |
( |
96 |
( |
79 |
( |
79 |
( |
79 |
( |
83 |
( |
82 |
( |
92 |
Treatment recommendations.
Treatment intervention | Patterns and agreement of experts % ( | |||
---|---|---|---|---|
Wind-cold-dampness pattern | Retained dampness-heat pattern | Dual deficiency of qi and blood pattern | Qi stagnation and blood stasis pattern | |
Acupuncture | 92 | 91 | 96 | 96 |
|
92 | 91 | 91 | 83 |
|
88 | — | — | 96 |
Moxibustion | 92 | — | 91 | 87 |
|
88 | — | 81 | — |
|
96 | — | 91 | 88 |
Acupuncture and moxibustion | 96 | — | 95 | 92 |
—, treatment modality CVI < 0.51: experts do not recommend this treatment modality.
In our final TCM pattern diagnosis for LEP instrument, we identified 25 local signs and symptoms and 45 systemic signs and symptoms, as well as 16 tongue and pulse features that may be associated with the four most commonly seen LEP patterns. Even though we laid emphasis on the four most commonly seen LEP patterns during the development of this questionnaire, it can also be used in the diagnostic process of identifying a mixed pattern presentation (e.g., dual deficiency of qi and blood coexisting with wind-cold-dampness).
The experts agreed on 99.6% of all items that were presented to them in the final Delphi round, and the mean CVI of all items in the final questionnaire was 0.88 (95% CI, 0.87 to 0.90), representing an 88% consensus level. We are therefore confident that our findings adequately represent a robust consensus of TCM expert opinions. Such high agreement might be because our initial questionnaire derived from a systematic review.
We chose clinical experts rather than academic experts for our Delphi panel and the experts came from many different countries across four continents. We, therefore, may assume that our Delphi findings represent the current international notion of TCM clinical practice in regard to LEP pattern diagnosis. The high level of agreement between the literature review (academic consensus) and Delphi experts (clinical consensus) then suggests that our findings have a high degree of generalizability of LEP pattern diagnosis in TCM theory and practice. The provisional instrument created via this Delphi study has achieved considerable content validity, yet requires further face-, criterion-, and construct-validity as well as test-retest and reliability testing before it may be clinically used. We are therefore currently conducting such studies for both the English as well as the Chinese language versions of the instrument.
Even though the primary aim of the study was to provide an instrument to assist with the pattern diagnosis of LEP, we also wanted to gather information for pattern-based treatments for future studies. Therefore, we asked the experts in the last section of the questionnaire which acupuncture/moxibustion treatment modalities they would recommend for which pattern (Table
In the literature [
There is a potential risk for bias in the expert selection, as the method is based on nonrandomized sampling. Therefore, representativeness cannot be assured [
After having performed a systematic review as the basis for the initial questionnaire, we felt comfortable to choose an agreement of 51% among experts as having achieved consensus. However, we would also like to point out that the mean consensus level for all items that remained at the end of round 2 was 88% and that 85.5% of all items (208 out of 243 items) reached a consensus level of over 70%, thus making our expert consensus much more robust than a consensus just defined by a de facto majority of 51%. We attempted to address the issue of subjectivity with retained items, as another potential criticism of our study, by having chosen an expert panel with a broad range of backgrounds and geographical regions. We also believe that the very robust level of consensus that was achieved with the majority of final items has minimized the risk of such subjectivity. However, one should bear in mind that expert consensus does not automatically mean that the right answers were found. Another limitation might be that due to the selection of experts, there might be acupuncture styles practiced that were not adequately represented in our expert panel. Lastly, while interpreting the results of our Delphi study one should acknowledge the potential influence of biases and that the current preliminary instrument will have to undergo rigorous validity and reliability testing before its clinical use can be recommended.
While the TCM pattern diagnosis system has the potential to refine treatment by identifying subtle differences in etiology, pathogenesis, and body constitution, a lack of standardization in terminology and consensus on diagnostic criteria are significant barriers. The provisional instrument derived from our study has obtained robust consensus and could be seen as a way of controlling information variance. It has been realized that similar sets of information must be collected and standardized terminology and diagnostic criteria must be used before consensus among practitioners in regard to the TCM pattern diagnosis can be reached [
The authors declare that they have no competing interests, including financial or nonfinancial interests from the funders.
Marcus Gadau, Shi-Ping Zhang, Wing-Fai Yeung, Zhao-Xiang Bian, and Ai-Ping Lu were responsible for the conception and the design of this study and the revision of the paper. Marcus Gadau, Shi-Ping Zhang, and Wing-Fai Yeung formed the research team and generated the initial questionnaire. Marcus Gadau conducted the Delphi survey and collected the questionnaires. Marcus Gadau, Shi-Ping Zhang, and Wing-Fai Yeung discussed survey results and provided feedback to the expert panel. Marcus Gadau performed the final analysis of the results. Marcus Gadau and Shi-Ping Zhang drafted the paper. All authors reviewed and approved the final paper.
The authors wish to thank the following members of the Delphi expert panel who agreed to be identified and participated in one round or both rounds of our survey: Sergio Bangrazi, Amerigo Boriglione, Edward Cheng, Shirley Cheng, Robert Doane, Dong Fang Hao, Lily Lai, Kyleen Lee, Ranic Leung, Hong Li, Wei Hong Li, Aldo Liguori, Stefano Liguori, Xin Lun, Carolyn Michaeil, Elmar Pestel, Filomena Petti, Rinaldo Rinaldi, Bernd Schleifer, Laura Silli, Yuan Sheng Tan, Robert Tronska, Florian Wagner, Sean Walsh, Jun Jun Yang, Xiao Fei Yang, Ann Yao, Chris Zaslawski, and Quan Ming Zhang. Marcus Gadau was supported by the UGC’s Hong Kong Ph.D. fellowship scheme 2013/14 (PF12-16701). This study was partially supported by HKBU Faculty Research Grants to Shi-Ping Zhang (FRG1/14-15/056).