Abstract
Introduction:
Acupuncturists must treat their patients empathetically, as this influences the outcome of acupuncture treatment. While the Consultation and Relational Empathy (CARE) measure is used globally to assess physician’s empathy from the patient’s perspective, to our knowledge, it has not been validated as a tool to assess acupuncturists’ empathy with general patients.
Objective:
To evaluate the validity and reliability of the Japanese version of the CARE measure to assess acupuncturist’s empathy from the patient’s perspective.
Methods:
A total of 22 acupuncturists participated in this study. Face validity was examined by the number of “not applicable” and missing items in the Japanese CARE measure. Construct (convergent) validity was evaluated based on the correlation between the Japanese CARE measure total score and overall treatment satisfaction. Internal consistency was measured using Cronbach’s alpha coefficient. Inter-rater reliability was examined based on generalizability theory. Principal component loadings were obtained using principal component analysis.
Results:
A total of 669 questionnaires were analyzed (response rate of 80.0%). The number of “not applicable” (0%–1.2%) and missing (0%–0.4%) responses were minimal, confirming face validity. The Japanese CARE measure total score and overall treatment satisfaction showed a strong positive correlation (Spearman’s ρ = 0.719, p < 0.001), confirming construct (convergent) validity. The questionnaire demonstrated high internal consistency with a Cronbach’s alpha of 0.979, confirming the reliability of internal consistency. To reliably estimate an acupuncturist’s empathy, 24 patient ratings per acupuncturist were needed. One principal component was identified.
Conclusion:
This study confirms the validity and reliability of the Japanese CARE measure for acupuncturists. It is expected to be utilized in both clinical practice and research.
Introduction
Effective communication is paramount for acupuncturists in diagnosing and planning treatment for the complex symptoms that patients may present with. 1 Furthermore, research suggests that establishing an empathetic relationships with patients can significantly enhance the effectiveness of acupuncture beyond the effects of needle insertion alone. 2 The patient and acupuncturist appear to influence each other during acupuncture stimulation, and there is evidence of inter-brain neural synchronization in the prefrontal cortex. 3 Empathy is a complex and multidimensional concept; according to Mercer and Reynolds, it includes the ability to: (a) understand the patient’s situation, perspective and feelings (and their attached meanings); (b) to communicate that understanding and check its accuracy; and (c) act on that understanding with the patient in a helpful (therapeutic) way. 4
Patients recognize their acupuncturists’ empathy as an important factor in seeing the acupuncturist as a caring professional, meaning that they are not just technicians, but also healers who respect their patients as individuals. 5 Acupuncturists’ empathy is also associated with increasing patient enablement.6,7 Enablement is a partially integrated index of patient satisfaction and health perspectives, and it means creating a state in which patients feel empowered and helped by the care of medical professionals. 8 In 2004, the English version of the Consultation and Relational Empathy (CARE) measure was developed as a questionnaire to assess physician’s empathy from the patient’s perspective.9,10 This 10-item questionnaire, utilizing a 5-point Likert-type scale, targets primary and secondary care physicians.9–12 The CARE measure (originally developed in the English language) is a globally acknowledged questionnaire that has demonstrated high validity and reliability in second-person evaluations from the patient’s perspective. 13 The Japanese version of the CARE measure was developed for general practitioners in 2014. 14 A subsequent analysis in 2018 utilized data from this study to validate its inter-rater reliability. 15
The CARE measure has also been widely used to quantify empathy in healthcare professionals other than physicians, such as nurses, psychotherapists, genetic counselors and complementary/alternative medicine practitioners. 16 For acupuncturists, studies have been conducted using the English CARE measure to examine the relationship between empathy and patient enablement,5,6 as well as acupuncturists’ empathy toward patients with anorexia nervosa. 17 The Chinese version of the CARE measure has been used to compare the empathy of Chinese herbalists, acupuncturists and massage therapists. 18
The questionnaire’s validity and reliability require re-examination when patient backgrounds vary.19–21 The English CARE measure has been re-examined for nurses engaged in primary care and sexual health.22,23 For acupuncturists, to our knowledge, the structural validity of the English CARE measure has only been examined in patients seeking rehabilitation for hip or knee pain. 20 It has been reported that patients treated for hip or knee osteoarthritis experience more psychological distress than general patients, 24 and the backgrounds of patients with hip or knee osteoarthritis differ from those of general patients attending acupuncture clinics. 25
This aim of this study was to examine the validity and reliability of the Japanese CARE measure as a tool to assess the empathy of acupuncturists, using general patients attending acupuncture clinics as raters.
Methods
Study design and participants
A cross-sectional study was conducted in urban acupuncture clinics. The study was approved by the Institutional Review Board of Nagoya University Graduate School of Medicine and Hospital (approval no. 2022-0201-4). The study is reported in line with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) cross-sectional reporting guidelines. 26
To meet the inclusion criteria, patients needed to be adults (18 years) and to have visited acupuncturists in Aichi Prefecture, Japan. There were no restrictions on gender and both initial and repeat visitors were eligible. Exclusion criteria included dementia, psychiatric disorders and severe acute illnesses that might hinder patients’ ability to answer the questionnaire or adversely affect their disease. The decision to exclude patients was made at the discretion of the acupuncturist in charge of the patient. A patient could only respond once to the acupuncturist. However, if a patient had multiple acupuncturists, responses for each acupuncturist were allowed.
In prior Japanese CARE measure studies, inter-rater reliability was established with 38 patients who responded appropriately to all 10 questions, 15 and 272 patients responded to all 10 questions for 9 physicians (with approximately 80% of patients responding appropriately to all questions). 14 Accordingly, in this study we aimed to collect questionnaires from 50 patients per acupuncturist, and a target of at least 10 acupuncturists was set.
Questionnaires, which consisted of the Japanese CARE measure and the patient background questionnaire, were distributed and collected from January to July 2023. The research collaborating institutions conducting the study were recruited from The Aichi Acupuncture and Moxibustion Association, a general incorporated association. A total of 22 acupuncturists (15 men and 7 women) working across 20 acupuncture clinics in Aichi Prefecture participated. The acupuncturists were 59 ± 10 years old (mean ± standard deviation (SD), range = 41–80 years) and had 32 ± 12 years of clinical experience (range = 10–51 years). There were no regulations regarding the acupuncturists’ attire. The researchers explained the study to the acupuncturists at the collaborating institutions and obtained their verbal consent. They also provided guidance on how to explain the study to patients and address anticipated queries.
For data collection, the acupuncturist explained the research plan to the patient according to the research instructions at the end of the visit. If the patient agreed to answer the questions, they received the questionnaires, research instructions and return envelope. The research instructions clearly stated that the acupuncturist could not identify individual patients from the questionnaire results. Written consent was obtained from participants. Patients answered the questionnaires without identifying themselves and submitted the completed questionnaires in a sealed return envelope to the collaborating institution or mailed them to the research office.
Questionnaire content
Each of the 10 items of the Japanese CARE measure was quantified using a 5-point Likert-type scale and a “not applicable” item, in line with previous studies. 14 The patient background questionnaire included both patient and treatment characteristics. 14 Patient characteristics comprised gender, age, marital status, educational level and employment status. 14 Treatment characteristics comprised number of treatments by the acupuncturist, intention to continue seeing the acupuncturist, treatment time (min), satisfaction with treatment time, patients’ knowledge of the acupuncturist, whether the patient would recommend the acupuncturist to family and friends, and overall treatment satisfaction. 14 In addition, a treatment characteristics survey was conducted on duration of treatment by the acupuncturist, reasons for visiting the acupuncture clinic, and number of complaints addressed.
Data analysis for validity and reliability
The Japanese CARE measure and the patient background questionnaire that were “not applicable” and missing were excluded from the analyses of construct (convergent) validity, inter-rater reliability, internal consistency and principal components analysis (PCA), except for examining face validity.
The face validity of the Japanese CARE measure was examined based on the number of items that were “not applicable” and missing in each question. To examine the construct (convergent) validity of the Japanese CARE measure, the correlation coefficients between the total score of the Japanese CARE measure and each of the questions in the patient background questionnaire (number of treatments by the acupuncturist, duration of treatment by the acupuncturist, treatment time, satisfaction with treatment time, patients’ knowledge of the acupuncturist, whether the patient would recommend the acupuncturist to family and friends, overall treatment satisfaction and patient age) were calculated using a two-sided Spearman’s ρ test at a significance level of 5%.
To examine the reliability of the Japanese CARE measure, the Cronbach’s alpha coefficient for the entire questionnaire was calculated for the strength of association of each question item. In addition, the “corrected item-total correlation” and “Cronbach’s alpha coefficient if the item is deleted” were obtained. Inter-rater reliability of the Japanese CARE measure was examined based on generalizability theory, consistent with prior research.10,15,27 A decision study was used to determine the intraclass correlation coefficient (ICC, generalizability coefficient) in each situation, with the condition that it exceed 0.8.10,15,27 Principal component loadings were obtained using PCA to examine common constructs among the questions in the Japanese CARE measure. Principal components were based on eigenvalues exceeding 1 or cumulative contribution of 80%. 28
Data are expressed as mean ± SD, median [interquartile range (IQR)] or n (%). Statistical analyses were conducted using the Statistical Package for the Social Sciences (SPSS) version 29 (IBM Corp., Armonk, NY, USA) for face validity, construct (convergent) validity, internal consistency and PCA, while G-string IV was used for inter-rater reliability.29,30
Results
Questionnaire administration
In total, 859 questionnaires were distributed and yielded 687 responses (80.0% response rate). Of these, 183 were submitted to collaborating institutions and 504 were mailed to the research office. After excluding 18 questionnaires without consent, 669 were analyzed. In total, 648 responded to all items of the Japanese CARE measure, corresponding to a deficiency rate of 3.1%.
Patient and treatment characteristics
Table 1 illustrates the characteristics of the 669 participants. They were 61 ± 15 years old (range = 18–92 years) and the majority were women. Table 2 shows the participants’ treatment characteristics. More than 85% reported being “very satisfied” or “completely satisfied” with their overall treatment. The participants were asked to freely describe the symptoms for which they sought treatment at the acupuncture clinic. Musculoskeletal symptoms (such as low back pain, shoulder stiffness, neck pain, frozen shoulder and knee pain) were most common. Symptoms such as dysmenorrhea, headaches, dizziness, tinnitus, insomnia, cold intolerance, autonomic nervous system imbalance and gastrointestinal discomfort were also observed. Nineteen acupuncturists wore white coats and three wore casual attire.
Patient characteristics (n = 669 patients).
Data are n (%).
Treatment characteristics (n = 669 patients).
Data are n (%) or median [IQR].
Japanese CARE measure analysis
The overall score of the 648 participants on the Japanese CARE measure was 40.5 [36.3–50.0]. Scores for individual acupuncturists ranged from 32.4 ± 8.2 to 47.4 ± 4.4. The Japanese CARE measure total score varied from a minimum of 10 to a maximum of 50. The average number of patients per acupuncturist was 29. No ceiling effect was observed for the overall mean score of the Japanese CARE measure, though questions 4–8 exhibited a ceiling effect, with scores ranging from 5.01 to 5.03.
Table 3 details the scores of items in the Japanese CARE measure for the 669 patients. The range of “not applicable” responses to each question item was 0% to 1.2%, and the range for missing responses was 0% to 0.4%. Regarding construct (convergent) validity, the correlation coefficients between the Japanese CARE measure total score and each of the questions in the patient background questionnaire were as follows. The number of treatments by the acupuncturist (ρ = 0.175, p < 0.001) and the duration of treatment by the acupuncturist (ρ = 0.107, p = 0.007) showed a very weak positive correlation. Treatment time (ρ = 0.243, p < 0.001) and knowledge about the acupuncturist (ρ = 0.376, p < 0.001) showed weak positive correlations. Satisfaction with treatment time (ρ = 0.614, p < 0.001) and the likelihood of recommending the acupuncturist to family and friends (ρ = 0.605, p < 0.001) demonstrated considerable positive correlation. Overall treatment satisfaction (ρ = 0.719, p < 0.001) showed a strong positive correlation. Patient age (ρ = –0.262, p < 0.001) showed a weak negative correlation.
Scores of items in the Japanese CARE measure questions (669 patients).
Data are n (%) or mean ± SD. Scores were given on a 5-point Likert-type scale, from poor (1) to excellent (5).
Regarding the questionnaire’s internal consistency, the overall Cronbach’s alpha coefficient for the items was 0.979, with corrected item-total correlation ranging from 0.828 to 0.918. The Cronbach’s alpha coefficient if the item was deleted ranged from 0.976 to 0.979. For inter-rater reliability, the harmonic mean of the number of patients responding to the questionnaire for each acupuncturist was 23.7 and the ICC at the time of the harmonic mean using the generalizability study was 0.8. The number of patients with an ICC of 0.802 (exceeding 0.8 using the decision study) was 24 (Table 4).
Generalizability coefficients using the decision study of the Japanese CARE measure (n = 648 patients).
ICC, intraclass correlation coefficient; CARE, consultation and relational empathy.
The 95% confidence interval (CI) for the overall mean score of the Japanese CARE measure for the 24 patients with an ICC of 0.802 was 38.3 to 44.5 points. The interval estimates of the mean score of the Japanese CARE measure for each acupuncturist were 44.10 points or higher for the top 25% and 38.17 points or lower for the bottom 25%, which are consistent with previous studies.10,15 Since the 95% CI of the fifth mean score from the bottom exceeded the mean overall score, the bottom cutoff was set at 38.09 points, the fourth from the bottom. This expressed a standard range of between 39 and 44 points, which are the extremes of the range (Figure 1). Regarding the PCA of the Japanese CARE measure, common constructs among the questionnaire items indicated one principal component. The eigenvalue was 8.4 and the contribution ratio was 84.5%. Items were not deleted given the significant correlations between them.

Interval estimation of the mean score (95% confidence interval (CI)) of the Japanese Consultation and Relational Empathy (CARE) measure for each acupuncturist (n = 22 acupuncturists and n = 24 patients).
Discussion
To our knowledge, this study is the first to examine the validity and reliability of the Japanese version of the CARE measure in assessing the empathy of acupuncturists with general patients. The Japanese CARE measure items had a low number of “non-applicable” and missing items, confirming its face validity, and the total score and overall treatment satisfaction showed a significant positive correlation, confirming its construct (convergent) validity. The overall Cronbach’s alpha coefficient for the examined items was high, confirming the reliability of internal consistency. Twenty-four patient ratings per acupuncturist were deemed adequate for a reliable estimation of the Japanese CARE measure mean score. The Japanese CARE measure demonstrated high principal component loadings, confirming one principal component as the common construct among the question items. The overall score for the Japanese CARE measure (n = 648) was 40.5 [36.3–50.0] with a standard range of 39–44.
The number of “not applicable” and missing items for each Japanese CARE measure question was minimal and comparable to findings from prior studies.10,11,14,22,23,27 The Japanese CARE measure total score and overall treatment satisfaction demonstrated a strong positive correlation, confirming construct (convergent) validity and comparability to general practitioners.14,27 Satisfaction with treatment time and likelihood of recommending the acupuncturist to family and friends each showed considerable positive correlations, while knowledge about the acupuncturist and treatment time each showed weak positive correlations, with acupuncturists and general practitioners yielding similar results. 14
Cronbach’s alpha coefficients for the overall Japanese CARE measure questionnaire items were high, confirming comparable reliability to findings from previous studies.9,11,14,22,23,27 Corrected item-total correlation was robust, with no items showing increased alpha coefficients when deleted. Twenty-four patient ratings per acupuncturist were deemed sufficient for a reliable Japanese CARE measure mean score estimate. Compared to the 50 primary care physicians for the English CARE measure, 10 38 general practitioners for the Japanese CARE measure, 15 and 60 nurses for the English CARE measure (ICC = 0.598 for 60 patients), 22 this study yielded satisfactory results with fewer patients. The small sample size of 24 could stem from a considerably low variance in the Japanese CARE measure scores between patients for each acupuncturist. This may explain the mitigating variance in the patient’s measurement error. In addition, the acupuncturists varied in gender, age and years of clinical experience. Therefore, the variance in the mean Japanese CARE measure scores between acupuncturists was likely high due to differences in acupuncturists’ empathy, and the effect of the variance in the patient’s measurement error was reduced. The Japanese CARE measure exhibited high principal component loadings, with common constructs among the questionnaire items showing one principal component, suggesting that it assesses empathy across a variety of different healthcare professionals.11,14,22,23
The Japanese CARE measure items 4–8 showed a slight ceiling effect, ranging from 5.01 to 5.03, consistent with findings from prior studies.22,23,31–33 The English CARE measure exhibited a higher ceiling effect than the Jefferson Scale of Patient’s Perception of Physician Empathy, 34 and the visual English CARE measure also exhibited a ceiling effect. 35 Patient satisfaction correlates with perceived empathy from health care practitioners. 36 Thus, the elevated scores in this study may reflect patients’ high level of satisfaction with their acupuncturist’s treatment. 37
This study has some limitations. First, acupuncturists participated voluntarily, without any incentives. Accordingly, potential volunteer bias may have influenced participation, with only those sensitive to empathy choosing to cooperate. Second, an experimental study in traditional Korean medicine setting reported that, when a traditional Korean medicine doctor conducted consultations wearing either a white coat or traditional dress, patients perceived significantly higher levels of empathy compared to when the doctor wore a suit or casual clothing. 38 By contrast, a quasi-randomized controlled trial conducted among Japanese family physicians found no significant difference in patient-perceived empathy between those wearing white coats and those in casual attire. 39 These findings suggest that the influence of clinician attire on patients’ perception of empathy may vary depending on the type of healthcare professional and cultural context. In the present study, acupuncturists’ attire was not standardized and, although its impact remains unclear, attire may be a potential confounding factor in the assessment of perceived empathy. Third, a potential selection bias exists as acupuncturists may have asked only patients they trusted to answer the questionnaires. Although patient selection bias cannot be completely mitigated, we sought to mitigate this issue by clarifying to each acupuncturist that: (1) the study’s purpose was not to let acupuncturists obtain a high questionnaire score; and (2) they should distribute questionnaires to patients who came to the clinic during the period, regardless of the relationship and degree of trust between the acupuncturist and patient. Despite these limitations, the results hold a degree of generalizability regarding patients’ characteristics. Patients treated by acupuncturists in this study shared characteristics with typical Japanese acupuncture patients, often aged 40 or older and predominantly presenting with musculoskeletal symptoms. 25
This study suggests that the Japanese version of the CARE measure is applicable for assessing the empathic abilities of acupuncturists with general patients. Given its validated and reliable nature (demonstrated through international evaluation), further studies are anticipated, including cross-national comparisons of acupuncturists’ empathy levels. As a self-assessment tool, 9 the CARE measure holds potential for enhancing rapport-building by quantifying and comparing patient-rated empathy. This may benefit both patients and acupuncturists, potentially ameliorating chronic pain, 40 and enhancing treatment efficacy.
Conclusion
The findings of this study support the validity and reliability of the Japanese CARE measure in acupuncturists. Further studies are expected to compare acupuncturists’ empathy globally.
Footnotes
Acknowledgements
We would like to express our sincere gratitude to the 22 acupuncturists who participated in this study. We would also like to express our sincere thanks to Makiko Ando, Tomomi Yamanaka and Etsuko Kimura (clerks at the Department of General Medicine, Nagoya University Graduate School of Medicine) for double-checking the digital database into which the questionnaire responses were entered. Finally, we would like to thank Editage (
) for English language editing.
Contributors
TK, NT, TM, MA, NB, SWM, JS: conceptualization; methodology. TK, NT, TM: data curation; formal analysis. TK, NT, TM, MA, JS: data interpretation. NT, TM: funding acquisition. JS: supervision. TK: writing (original draft). TK, NT, TM, MA, NB, SWM, JS: Writing (review and editing). All authors read and approved the final version of the manuscript accepted for publication.
Declaration of conflicting interests
The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: As Dr Noriyuki Takahashi is a faculty member of the endowed chair, there is a conflict of interest with Aichi Prefecture and Nagoya City, which provided the funding for establishing the chair. However, Aichi Prefecture and Nagoya City did not intervene in any way in the planning, implementation or evaluation of this study.
Funding
The authors disclosed receipt of the following financial support for the research, authorship and/or publication of this article: This work was supported by the Japan Society for the Promotion of Science (grant no. JP19K19352 and JP20K10375).
Ethical considerations
The study was approved by the Institutional Review Board of Nagoya University Graduate School of Medicine and Hospital (approval no. 2022-0201-4).
Consent to participate
For data collection, the acupuncturist explained the research plan to the patient according to the research instructions at the end of the visit. If the patient agreed to answer the questions, they received the questionnaires, research instructions and return envelope. Research instructions clearly stated that the acupuncturist could not identify individual patients from the questionnaire results. Written consent was obtained from participants.
Consent for publication
Not applicable.
