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Promoting empathy among medical students: A two-site randomized controlled study
Accepted Manuscript Promoting empathy among medical students: A two-site randomized controlled study
Céline Buffel du Vaure, Cédric Lemogne, Lucie Bunge, Annie Catu-Pinault, Nicolas Hoertel, Christian Ghasarossian, Marie-Eve Vincens, Eric Galam, Philippe Jaury PII: DOI: Reference:
S0022-3999(17)30759-6 doi:10.1016/j.jpsychores.2017.10.008 PSR 9423
To appear in:
Journal of Psychosomatic Research
Received date: Revised date: Accepted date:
12 June 2017 15 October 2017 15 October 2017
Please cite this article as: Céline Buffel du Vaure, Cédric Lemogne, Lucie Bunge, Annie Catu-Pinault, Nicolas Hoertel, Christian Ghasarossian, Marie-Eve Vincens, Eric Galam, Philippe Jaury , Promoting empathy among medical students: A two-site randomized controlled study. The address for the corresponding author was captured as affiliation for all authors. Please check if appropriate. Psr(2017), doi:10.1016/j.jpsychores.2017.10.008
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ACCEPTED MANUSCRIPT Promoting Empathy among medical students: a two-site randomized controlled study
Céline Buffel du Vaurea,b,* MD, PhD; Cédric Lemognec,d,e, MD, PhD; Lucie Bungef MD; Annie Catu-Pinaulta,g MD; Nicolas Hoertelc,d,e MD; Christian Ghasarossiana MD, Professor;
a
Université Paris Descartes, Sorbonne Paris Cité, Faculté de Médecine, Département de Médecine
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Générale, 24 rue du Faubourg Saint Jacques, 75014, Paris, France
METHODS Team, Epidemiology and Statistics Sorbonne Paris Cité, Research Center UMR 1153,
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b
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Marie-Eve Vincensg,h MD; Eric Galamf MD, Professor; Philippe Jaurya,g MD, Professor
Inserm, 1 place du parvis de Notre Dame, 75004, Paris, France
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d
Université Paris Descartes, Sorbonne Paris Cité, Faculté de Médecine, Paris, France AP-HP, Hôpitaux Universitaires Paris Ouest, Service de Psychiatrie de l’adulte et du sujet âgé, 20
Rue Leblanc, 75015, Paris, France e
Inserm,
U894,
Centre
f
Psychiatrie
et
Neurosciences,
2
ter,
rue
d'Alésia
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75014, Paris, France
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c
Université Paris Diderot, Sorbonne Paris Cité, Faculté de Médecine, Département de Médecine
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Générale, 16 rue Henri Huchard 75018, Paris, France Société Médicale Balint, 10 Route de Thionville, 57140 Woippy, France
h
Université Paris 13, Sorbonne Paris Cité, Département de Médecine Générale, 74 rue Marcel Cachin
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g
93017, Bobigny Cedex, France
Word count : 2919
* Corresponding author: Dr Céline Buffel du Vaure Département de Médecine Générale, Faculté de Médecine Paris Descartes 24 rue du Faubourg Saint Jacques, 75014 PARIS, France tel 0033 144412363 [email protected]
ACCEPTED MANUSCRIPT Abstract Objective: To assess the effects of Balint groups on empathy measured by the Consultation And Relational Empathy Measure (CARE) scale rated by standardized patients during objective structured clinical examination and self-rated Jefferson’s School Empathy Scale Medical Student (JSPE-MS©) among fourth-year medical students.
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Methods: A two-site randomized controlled trial were planned, from October 2015 to
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December 2015 at Paris Diderot and Paris Descartes University, France. Eligible students
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were fourth-year students who gave their consent to participate. Participants were allocated in equal proportion to the intervention group or to the control group. Participants in the
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intervention group received a training of 7 sessions of 1.5-hour Balint groups, over 3 months. The main outcomes were CARE and the JSPE-MS© scores at follow-up.
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Results: Data from 299 out of 352 randomized participants were analyzed: 155 in the intervention group and 144 in the control group, with no differences in baseline measures.
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There was no significant difference in CARE score at follow-up between the two groups
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(P=0.49). The intervention group displayed significantly higher JSPE-MS© score at followup than the control group [Mean (SD): 111.9 (10.6) versus 107.7 (12.7), P=0.002]. The JSPEMS© score increased from baseline to follow-up in the intervention group, whereas it
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decreased in the control group [1.5 (9.1) versus -1.8 (10.8), P=0.006]. Conclusions: Balint groups may contribute to promote clinical empathy among medical students.
Trial Registration: NCT02681380 Word count for abstract: 222
ACCEPTED MANUSCRIPT Introduction
Empathy can be defined as the ability to share and/or understand others’ emotional state without confusion between self and others. Clinical empathy, i.e. empathy within the context of a doctor-patient relationship, is considered as a core feature of the doctor-patient 1,2
, as acknowledged by most of medical schools. For instance, the Association of
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relationship
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American Medical Colleges states that “physicians must be compassionate and empathetic in
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caring for patients”.3 Results of several observational studies have shown that doctors’ empathic abilities are associated with better patient satisfaction, more accurate clinical
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assessment, better therapeutic alliance, which in turn may lead to better compliance and better related medical outcomes with diminished costs.1 Unfortunately, several cross-sectional and
during medical training
4–6
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longitudinal studies have documented a weak, yet significant decline of the empathic abilities .
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Several controlled interventions have attempted to promote empathic abilities among
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already certified physicians 1. Since clinical empathy also encompasses the physician’s ability to communicate his or her understanding of the emotional state of the patient, most of these interventions targeted communication skills
7
. When evaluated by the patient (either real or
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simulated), these interventions have shown significant, but small effect size 7. In the context of medical school, several interventions have been proposed to promote medical students’ empathic abilities such as narrative medicine groups
11
, videotaped case analyses
12
8,9
, theatre groups
or Balint groups
10
13
, experience sharing in small
. However, none of these
interventions have been evaluated using a randomized controlled design. A preliminary non-randomized comparative study by our group suggested that Balint groups may be efficient in enhancing empathic reactions measured on specifically designed case-reports
13
. Balint groups are specifically designed to help health-professionals and
ACCEPTED MANUSCRIPT medical students in developing their empathy skills to reduce interpersonal difficulties while taking into account emotional issues
14–16
. These interventions differ from problem-based
learning because they aim to develop empathic abilities rather than medical knowledge
17
.
Based on our preliminary report, the present study aims to assess the efficacy of Balint groups in improving empathy measured by the Consultation And Relational Empathy Measure
Examination (OSCE) Student (JSPE-MS©)
by
standardized
patients
during
Objective
Structured
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rated
Clinical
18
and the self-rated Jefferson’s School Empathy Scale - Medical
5
among fourth-year medical students, in a two-site randomized
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scale
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(CARE)
controlled trial. We also aimed to examine the potential moderating role of site, gender or
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baseline empathy on this intervention.
ACCEPTED MANUSCRIPT Methods
Design We planned a two-site parallel-group randomized controlled trial assessing the efficacy of Balint groups versus control on clinical empathy among fourth-year medical
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students.
Paris,
France
(number
00001072),
and
the
protocol is
registered
at
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University,
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The study obtained ethics approval from the Institutional Review Board of Paris Descartes
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ClinicalTrials.gov (NCT02681380).
Setting and Participants
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The study was conducted from October 2015 to December 2015 at Paris Diderot and Paris Descartes University (Paris, France). Eligible students were fourth-year medical
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students who gave their consent to participate through a secured website. At Paris Diderot, the study was proposed to a random sample of 140 students. At Paris Descartes, in which the
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fourth-year curriculum includes three mandatory consecutive 3-month learning programs in random order, the study was proposed to two thirds of the students (N=262), according to the
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program they had to follow first (see below). There were no exclusion criteria.
Randomization
Eligible students were allocated in equal proportion to the intervention group or to the control group. Students from Paris Diderot were randomized with a simple randomization using computer-generated random numbers. Among students from Paris Descartes, we took advantage of the randomization routinely performed each year by the University staff to allocate each student to one of three groups, each corresponding to a particular order of the
ACCEPTED MANUSCRIPT three mandatory 3-month programs of the fourth-year curriculum. During the study interval, one of these programs included Balint groups as the only teaching related to clinical empathy. The participants who followed this program first were considered as the intervention group. Another 3-month program did not include such specific teaching. The participants who followed this program first were considered as the control group. The third 3-month program
8,9
.
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have effects on empathy
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was not included in this study because it included narrative medicine teachings that could
Intervention
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Regardless of the site, the students in the intervention group were randomly split into groups of 12 or 13 students. Each group received a training over 2 months that included 7
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weekly 1.5-hour Balint group sessions. Participants in Balint groups were asked to react to a particularly touching, upsetting or interesting live clinical situation that involves interpersonal 13
. This training was not specifically
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problems, under the supervision of a trained facilitator
tailored to improve empathy and did not differ from usual Balint group sessions. Before the
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beginning of the study, all the facilitators were accredited as Balint groups’ leaders either by the French Balint Medical Society (Société Médicale Balint France) or the Balint Training
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Association (Association de Formation Balint). To homogenize the intervention, regular meetings among facilitators were organized before and during the study. Students included in the control group received no specific training.
Procedure Baseline characteristics were self-reported and included gender, site (Paris Diderot University or Paris Descartes University), education level of the most educated parent (primary / secondary, undergraduate or graduate / postgraduate), living status (alone, with
ACCEPTED MANUSCRIPT parents, as couple, or other), anticipated specialty choice (anesthesia/emergency/intensive care, surgery, medicine, psychiatry or non-clinical specialty)
19
. In addition, all participants
had to complete the validated French version of the JSPE-MS©
20
at baseline through a
secured website. This scale encompasses 20 items Likert-type items, rated from 1 (strongly disagree) to 7 (strongly agree) (e.g. “Patients feel better when their physicians understand
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their feelings”), leading to a summed score ranging from 20 to 140 with higher score
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indicating higher levels of empathy.
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One week after the last Balint group session, all intervention and control group participants had to complete the JSPE-MS© again and then participate in two sessions of
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patient simulation during OSCE of 15 minutes. Standardized patients were simulated by actors. An observer was present during all sessions. Scenarios were designed by a panel of
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experts that inclued 4 general practitioners and 1 psychiatrist. Two fictive cases were constructed: one case regarding announcement of HIV status and one case regarding
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inappropriate demand of antibiotic delivery. No physical examination was requested.
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Standardized patients fulfilled the CARE scale immediately after each OSCE (i.e. two measures). The CARE scale is a 10-item patient-rated questionnaire of physician empathy [e.g. “How good was the practitioner at showing care and compassion (seeming genuinely
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concerned, connecting with you on a human level; not being indifferent or detached)?”]
21
.
Each item can be scored on a Likert scale from 1 (poor) to 5 (excellent), with a ‘does not apply’ option, leading to a summed score ranging from 10 to 50 with higher score indicating higher levels of empathy.
Blinding Whereas students and facilitators were aware of the allocated group, standardized patients, OSCE’s observers and data analysts were kept blinded to the allocation.
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Statistical analysis Primary outcomes were the mean CARE score (across both scenarios) and the JSPEMS© score at follow-up. Secondary outcome was the change in JSPE-MS© score from baseline to follow-up.
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Based on a literature-driven hypothesis of a 4-point between-group difference with a
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SD of 12 points regarding the JSPE-MS© score 4 , we calculated that 144 participants per
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group were needed to ensure a significance level of 5% and a power of 80%. With an estimation of 10% of missing data, we decided to approach 160 participants per group
22
.
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Because of a technical problem, data were systemically missing for one item (i.e. “Physicians should try to stand in their patients’ shoes when providing care to them”) of the
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JSPE-MS©. However, the internal consistency in our sample was good (Cronbach’s alpha: 0.77 and 0.80 for the baseline and follow-up measures, respectively) and thus allowed
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computing a one-dimension global score based on the mean item value multiplied by 20. Likewise, the internal consistency of the CARE scale was excellent (Cronbach’s alpha: 0.95
apply’ answers).
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for both scenarios), allowing similar computation for missing data (including few ‘does not
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Descriptive results were reported with means and SDs for quantitative variables or absolute frequencies and percentages by modality for qualitative variables. Between-group differences regarding the covariates and the outcome measures were tested with Student’s ttest for continuous variables and Chi-square tests for categorical variables. Statistical significance was evaluated using a two-sided design with alpha set a priori at 0.05. Exploratory analyses aimed at looking for a moderating effect of site, gender and baseline JSPE-MS© score. Whenever an interaction between group and one of these factors (including
ACCEPTED MANUSCRIPT the group, the factor and the interaction term in a general linear model) was found, stratified analyses were performed. Sensitivity analyses relied on a general linear model to adjust the results for participants’ characteristics that tend to differ between the intervention and the control group with a p-value < 0.10. Finally, for participants who were allocated to one group but who did
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not complete the empathy assessment, we used their JSPE-MS© score at baseline as the
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JSPE-MS© score at follow-up.
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All statistical analyses were computed using SPSS 16.0.1 software (SPSS Inc.,
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Chicago, IL, USA).
ACCEPTED MANUSCRIPT Results
Participants Among the 352 students who were allocated to either the intervention or the control group, 53 did not participate to the OSCE or did not complete the JSPE-MS© at follow-up.
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This resulted in a final sample of 299 participants, including 155 in the intervention group and
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144 in the control group (Figure 1 – Flow diagram). There was no significant difference
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regarding participants’ characteristics and group allocation between these 299 participants and the 53 students who did not complete the empathy assessment (Supplemental Table 1).
Empathy measures at follow-up
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JSPE-MS© score at baseline (Table 1).
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The two groups did not differ regarding sociodemographic factors, specialty choice or
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Table 2 displays CARE and JSPE-MS© scores at follow-up and changes in JSPEMS© scores from baseline to follow-up, according to the group. There was no significant
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difference in mean CARE score at follow-up between the two groups (P=0.49). The intervention group participants displayed a significantly higher mean JSPE-MS© score at
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follow-up than the participants from the control group [mean (SD): 111.9 (10.6) versus 107.7 (12.7), t=3.08, P=0.002]. The mean JSPE-MS© score increased from baseline to follow-up among the intervention group, whereas it decreased among the control group [1.5 (9.1) versus -1.8 (10.8), t=2.79, P=0.006].
Exploratory analyses Regarding the CARE score, the group by site interaction was not significant (P=0.348) but the group by gender interaction and the group by baseline JSPE-MS© median split
ACCEPTED MANUSCRIPT interaction were both significant (P=0.007 and P=0.035, respectively). Stratified analyses by gender showed higher CARE scores among the intervention (versus control) group for men [66.3 (15.9) versus 59.4 (12.6), t=2.67, P=0.009] but not among women [60.9 (16.7) versus 63.7 (13.9), t=1.18, P=0.241]. Stratified analyses according to the baseline JSPE-MS© median score showed higher CARE scores in the intervention (versus control) group among
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the participants with a score above the median [67.1 (17.1) versus 62.1 (13.9), t=1.99,
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P=0.048], but not among those with a score below the median [59.7 (15.2) versus 62.0 (13.4),
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t=1.00, P=0.321].
Regarding the JSPE-MS© score at follow-up or the change in JSPE-MS© score from
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baseline to follow-up, the group by site and group by gender interactions were not significant (all P≥0.356), which prevented further stratified analyses.
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Among the intervention group, there was no significant difference in JSPE-MS© scores at follow-up between participants who attended 7 sessions [112.6 (9.9), N=82], 6
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Sensitivity analyses
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sessions [111.2 (10.0), N=52] or only 3 to 5 sessions [110.7 (14.4), N=21] (F=0.43, P=652).
Adjusting our results for participants’ characteristics that tend to differ between the
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intervention and the control group in a general linear model (i.e. gender, parents’ education level and specialty choice) yielded similar results regarding both the mean JSPE-MS© score at follow-up [estimated mean (standard error): 112.6 (2.1) versus 108.4 (2.1), F=9.37, P=0.002] and the changes in mean JSPE-MS© score from baseline to follow-up [estimated mean (standard error): 2.8 (1.8) versus -0.6 (1.8), F=7.96, P=0.005]. Finally, we included the 53 students who did not complete the empathy assessment, using their JSPE-MS© score at baseline as the JSPE-MS© score at follow-up. This sensitivity analysis yielded similar results, the intervention group displaying higher JSPE-MS© score at
ACCEPTED MANUSCRIPT follow-up than the control group [mean (SD): 111.2 (11.0) versus 107.7 (12.6), t=2.68, P=0.008] and the JSPE-MS© score increased from baseline to follow-up among the intervention group and decreased from baseline to follow-up among the control group [1.2
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(9.0) versus -1.2 (11.2), t=2.16, P=0.031].
ACCEPTED MANUSCRIPT Discussion
The present study aimed to use a randomized controlled design to test the efficacy of an intervention based on the use of Balint groups to promote empathy among medical students. Compared to a control group, the intervention showed increased levels of self-
empathy was consistent across site,
gender and baseline empathy levels.
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reported
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reported empathy and similar levels of externally evaluated empathy. This effect on self-
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Furthermore, exploratory analyses found some support for a positive effect of the intervention on externally evaluated empathy among men as well as among participants having the highest
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levels of self-reported empathy at baseline. Finally, sensitivity analyses showed that these results were robust.
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To our knowledge, this is the first experimental study to examine the efficacy of an intervention aimed at promoting empathy during medical school. This study has several
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strengths, including its two-site randomized controlled design and the use of both self-report and externally assessed measures of empathy. Since empathy is critically modulated by 23
, it is noteworthy that these two measures focused on empathy in the
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contextual factors
context of the doctor-patient relationship. Indeed, our preliminary study found no group
13
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differences with a less specific measure of empathy such as the Interpersonal Reactivity Index . The similar effect observed at the two sites provides some support to the possible
reliability and generalization of the intervention to other settings. Because 85% of the students in the intervention group missed no more than one of the seven sessions we could not show a significant association between Balint group attendance and changes in self-reported empathy, but this suggests that this intervention is well-accepted. Additionally, the weak, yet significant decline in self-reported empathy observed among the control group is consistent with the literature
4–6
, and this also provides some support to the external validity of the present study.
ACCEPTED MANUSCRIPT Some limitations should be acknowledged. First, one could argue that the effect size of the intervention was rather small and could be of limited duration after the end of the training. However, this effect was observed over 2 months only whereas Balint groups are meant to be implemented over a longer period of time. Further studies might examine whether longer exposure to Balint groups, as recommended, may result in greater effect size, and whether
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sustained effects could be observed in the long run. Second, the two groups in Paris Descartes
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University also differed regarding the exposure to other learning programs (i.e. cardiology,
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respiratory medicine and intensive care medicine for the control group versus orthopedic surgery, rheumatology and dermatology for the intervention group). However, none of these specifically
relates
to
empathy or doctor-patient relationship.
Furthermore,
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programs
exploratory analyses found no support for a moderating effect of site, suggesting that the
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effect of the intervention was not driven by one university only. The intervention tested in the present study might be more efficient for self-reported
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empathy than externally assessed empathy. Externally assessed empathy might focus more on the students’ ability to communicate his or her understanding of the emotional state of the
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patient than on this understanding per se. In other words, the intervention could have fostered students’ empathy while failing to improve the communication skills needed to improve
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perceived empathy.
Several explanations could account for the effects observed on self-reported empathy. First, it could result from increased social desirability of empathy rather than from increased empathic abilities per se. Such interpretation would indeed be consistent with the fact that promoting the value of empathy in the context of doctor-patient relationship is at the core of the intervention. Empathic abilities are useless if they are not actually implemented in clinical practice and the so-called decline of empathy during medical school is more likely to be a decline of the perceived value of empathy, as captured by the majority of the JSPE-MS©
ACCEPTED MANUSCRIPT items13,24,25 . Most of the accounts of this decline build on the value given to empathy (e.g. by significant models such as senior physicians
26
), rather than on empathic abilities per se. Other
factors may contribute to this phenomenon such as teaching methods
27
(e.g. prioritizing a
purely biomedical approach), selection procedures which may not favor the most empathic students
28
or coping strategies based on emotional distancing
29
. Second, beside the
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promotion of empathy as a value shared by the medical community, the use of Balint groups
14,30
. For instance, perspective-taking may protect
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emotions elicited by clinical practice
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may also decrease self-distancing by providing medical students with other tools to regulate
physicians from such detrimental effects while allowing them to show sustained empathic 31
.
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concern
The present results also suggest that men and participants with higher levels of
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baseline self-reported empathy may be more prone to take advantage of the intervention to increase their communication skills, as assessed by a simulated patient during an OSCE.
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These results might sound contradictory as men usually displayed lower levels of self-
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reported empathy. Women might have been less sensitive to the intervention as a result of a ceiling effect whereas participants with higher levels of JSPE-S scores might have been more prone to take an active part during Balint groups.
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In conclusion, the results of the present study provide the initial evidence of the efficacy of Balint groups to promote the humanistic value of empathy among medical students. Further studies should attempt to determine whether some subgroups, such as men in the current study, are more likely to benefit from such intervention. This intervention should also be tested against other types of intervention aimed at promoting empathy, such as narrative medicine
8,9
.
ACCEPTED MANUSCRIPT References Kelm Z, Womer J, Walter JK, Feudtner C. Interventions to cultivate physician empathy: a systematic review. BMC Med Educ. 2014;14:219. doi:10.1186/1472-6920-14-219.
2.
Hemmerdinger JM, Stoddart SDR, Lilford RJ. A systematic review of tests of empathy in medicine. BMC Med Educ. 2007;7:24. doi:10.1186/1472-6920-7-24.
3.
Learning objectives for medical student education--guidelines for medical schools: report I of the Medical School Objectives Project. Acad Med J Assoc Am Med Coll. 1999;74(1):13-18.
4.
Neumann M, Edelhäuser F, Tauschel D, et al. Empathy decline and its reasons: a systematic review of studies with medical students and residents. Acad Med J Assoc Am Med Coll. 2011;86(8):996-1009. doi:10.1097/ACM.0b013e318221e615.
5.
Hojat M, Vergare MJ, Maxwell K, et al. The devil is in the third year: a longitudinal study of erosion of empathy in medical school. Acad Med J Assoc Am Med Coll. 2009;84(9):1182-1191. doi:10.1097/ACM.0b013e3181b17e55.
6.
Colliver JA, Conlee MJ, Verhulst SJ, Dorsey JK. Reports of the decline of empathy during medical education are greatly exaggerated: a reexamination of the research. Acad Med J Assoc Am Med Coll. 2010;85(4):588-593. doi:10.1097/ACM.0b013e3181d281dc.
7.
Moore PM, Rivera Mercado S, Grez Artigues M, Lawrie TA. Communication skills training for healthcare professionals working with people who have cancer. Cochrane Database Syst Rev. 2013;3:CD003751. doi:10.1002/14651858.CD003751.pub3.
8.
Charon R, Wyer P, NEBM Working Group. Narrative evidence based medicine. Lancet Lond Engl. 2008;371(9609):296-297.
9.
Goupy F, Abgrall-Barbry G, Aslangul E, et al. [Can narrative medicine be an answer to patient physician relationship teaching according to students’ demand in medical education curricula?]. Presse Médicale Paris Fr 1983. 2013;42(1):e1-8. doi:10.1016/j.lpm.2012.09.012.
10.
Dow AW, Leong D, Anderson A, Wenzel RP, VCU Theater-Medicine Team. Using theater to teach clinical empathy: a pilot study. J Gen Intern Med. 2007;22(8):1114-1118. doi:10.1007/s11606-007-0224-2.
11.
Branch WT, Pels RJ, Hafler JP. Medical students’ empathic understanding of their patients. Acad Med J Assoc Am Med Coll. 1998;73(4):360-362.
12.
Suchman AL, Markakis K, Beckman HB, Frankel R. A model of empathic communication in the medical interview. JAMA. 1997;277(8):678-682.
13.
Airagnes G, Consoli SM, De Morlhon O, Galliot A-M, Lemogne C, Jaury P. Appropriate training based on Balint groups can improve the empathic abilities of medical students: a preliminary study. J Psychosom Res. 2014;76(5):426-429. doi:10.1016/j.jpsychores.2014.03.005.
14.
Freyberger H, Besser L. Teaching psychosomatic medicine with special reference to the Balint group and the case supervision group. Psychother Psychosom. 1982;38(1):239-243.
15.
Torppa MA, Makkonen E, Mårtenson C, Pitkälä KH. A qualitative analysis of student Balint groups in medical education: contexts and triggers of case presentations and discussion themes. Patient Educ Couns. 2008;72(1):5-11. doi:10.1016/j.pec.2008.01.012.
AC C
EP T
ED
MA
NU
SC
RI
PT
1.
ACCEPTED MANUSCRIPT Van Roy K, Vanheule S, Inslegers R. Research on Balint groups: A literature review. Patient Educ Couns. 2015;98(6):685-694. doi:10.1016/j.pec.2015.01.014.
17.
Neville AJ. Problem-based learning and medical education forty years on. A review of its effects on knowledge and clinical performance. Med Princ Pract Int J Kuwait Univ Health Sci Cent. 2009;18(1):1-9. doi:10.1159/000163038.
18.
Brannick MT, Erol-Korkmaz HT, Prewett M. A systematic review of the reliability of objective structured clinical examination scores. Med Educ. 2011;45(12):1181-1189. doi:10.1111/j.13652923.2011.04075.x.
19.
Rotge J-Y, Lemogne C, Jouvent R, Fossati P. Relationship between personality dimensions and medical specialty in 1661 residents. J Psychosom Res. 2015;79(4):331-332. doi:10.1016/j.jpsychores.2015.06.009.
20.
Alexandre Bitoun. Validation du score JSPE-Medical Student© en langue française dans l’évaluation de l’empathie des étudiants en médecine (MD dissertation). February 2017.
21.
Mercer SW, Maxwell M, Heaney D, Watt GC. The consultation and relational empathy (CARE) measure: development and preliminary validation and reliability of an empathy-based consultation process measure. Fam Pract. 2004;21(6):699-705. doi:10.1093/fampra/cmh621.
22.
Norman G, Streiner D. PDQ Statistics. London. London: BC Decker Inc.; 1999.
23.
Decety J, Jackson PL. The functional architecture of human empathy. Behav Cogn Neurosci Rev. 2004;3(2):71-100. doi:10.1177/1534582304267187.
24.
Pedersen R. Empirical research on empathy in medicine-A critical review. Patient Educ Couns. 2009;76(3):307-322. doi:10.1016/j.pec.2009.06.012.
25.
Lemogne C. [EMPATHY IN MEDICINE, NECESSARY BUT NOT FREE FROM RISKS]. Rev Prat. 2015;65(8):1027-1030.
26.
Newton BW, Barber L, Clardy J, Cleveland E, O’Sullivan P. Is there hardening of the heart during medical school? Acad Med J Assoc Am Med Coll. 2008;83(3):244-249. doi:10.1097/ACM.0b013e3181637837.
27.
Garden R. Expanding clinical empathy: an activist perspective. J Gen Intern Med. 2009;24(1):122-125. doi:10.1007/s11606-008-0849-9.
28.
Chen DCR, Kirshenbaum DS, Yan J, Kirshenbaum E, Aseltine RH. Characterizing changes in student empathy throughout medical school. Med Teach. 2012;34(4):305-311. doi:10.3109/0142159X.2012.644600.
29.
Halpern J. What is clinical empathy? J Gen Intern Med. 2003;18(8):670-674.
30.
Turner AL, Malm RL. A preliminary investigation of balint and non-balint behavioral medicine training. Fam Med. 2004;36(2):114-122.
31.
Gleichgerrcht E, Decety J. Empathy in clinical practice: how individual dispositions, gender, and experience moderate empathic concern, burnout, and emotional distress in physicians. PloS One. 2013;8(4):e61526. doi:10.1371/journal.pone.0061526.
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ACCEPTED MANUSCRIPT Acknowledgments We thank the Jefferson Medical College for their permission to use the French version of the JSPE-MS© scale. We thank Gérard Friedlander, Benoit Schlemmer and Jean-Luc Dumas for having authorized the implementation of the study, Antoine Tesnière for having reviewed the project at
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University Paris Descartes, François Goupy for his help in managing the web-based data
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collection and Jacques Blacher for the implementation of the OSCEs at Hôtel-Dieu Hospital
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(Paris, France). We also thank the facilitators of the Balint groups (Françoise Auger, Martine Fabre, Joëlle Lehmann, Marie-Anne Puel, Pascale Hauvespre, Louis Velluet). We are
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particularly indebted to Louis Velluet for having developed Balint groups for medical students in France. Finally, we thank the actors involved in the OSCEs as well as the residents
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involved in the implementation of the OSCEs. Funding
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This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
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Competing interest declaration
None of the authors has any financial conflict of interests to report.
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Authors’ contributions
All authors participated in the conception and design of the study and to the collected of the data. CL performed the statistical analysis. All authors interpreted the results. CL and CBV drafted the manuscript and all authors revised the manuscript critically for important intellectual content. All authors read and approved the final version of the manuscr ipt. Transparency declaration
ACCEPTED MANUSCRIPT PJ affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; no important aspects of the study have been omitted; and that any discrepancies from the study as planned have been explained. Data sharing statement
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Data sharing: no additional data available.
ACCEPTED MANUSCRIPT Table 1. Participants’ characteristics at baseline according to group allocation Intervention group (N=155) N %
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4 11 140
2.6 7.1 90.3
46 73 16 18 2
94 50
29.7 47.1 10.3 11.6 1.3
109 35
75.7 24.3
11 6 127
7.6 4.2 88.2
34 73 12 21 4
χ2 3.81
P 0.051
0.05
0.826
4.97
0.083
2.03b
0.566b
8.36
0.079
65.3 34.7
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76.8 23.2
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Parental education level a Primary / secondary Undergraduate Graduate / postgraduate Living status Alone With parents As couple Other Missing Specialty choice Anesthesia/emergency/intensive care Surgery Medicine Psychiatry Non-clinical specialty Balint groups attendance 7 sessions 6 sessions 3-5 sessions
119 36
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Site Paris Descartes University Paris Diderot University
54.2 45.8
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84 71
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Gender Female Male
Control group (N=144) N %
23.6 50.7 8.3 14.6 2.8
12 21 115 7 0
7.7 13.5 74.2 4.5 0.0
8 28 105 1 2
5.6 19.4 72.9 0.7 1.4
82 52 21 Mean
52.9 33.5 13.5 SD
Mean
SD
t
P
11.8 11.7 12.1
0.60 0.49 0.74
0.547 0.624 0.464
JSPE-MS© score Full sample 110.3 10.2 109.5 Female 111.4 10.6 110.6 Male 109.0 9.7 107.6 a education level of the most educated parent b after exclusion of the missing data JSPE-MS©: Jefferson Scale of Physician Empathy for Medical Students
ACCEPTED MANUSCRIPT Table 2. Post-intervention empathy measures.
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Intervention group Control group (N=155) (N=144) Mean SD Mean SD CARE scores at follow-up 63.4 16.5 62.2 13.6 JSPE-MS© score at follow-up 111.9 10.6 107.7 12.7 a Change in JSPE-MS© score 1.5 9.1 -1.8 10.8 CARE: Consultation And Relational Empathy Measure JSPE-MS©: Jefferson Scale of Physician Empathy for Medical Students a from baseline to follow-up
t 0.69 3.08 2.79
P 0.488 0.002 0.006
ACCEPTED MANUSCRIPT Figure 1. Flow diagram
Assessed for eligibility (n=402) Paris Diderot (n=140) Paris Descartes (n=262)
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Enrollment
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Excluded (n=50) Declined to participate (n=50)
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Randomized (n=352) Paris Diderot (n=90) Paris Descartes (n=262)
Allocation
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Allocated to intervention (n=176) Paris Diderot (n=45) Paris Descartes (n=131)
Follow-Up
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Lost to follow-up (n=21) Did not attended at least 1 session (n=5) Lack of assessment at follow-up (n=16)
Analysed (n=155) Paris Diderot (n=36) Paris Descartes (n=119) Excluded from analysis (n=21) Included in sensitivity analysis (n=176)
Allocated to control (n=176) Paris Diderot (n=45) Paris Descartes (n=131)
Lost to follow-up (n=32) Lack of assessment at follow-up (n=32)
Analysis Analysed (n=144) Paris Diderot (n=35) Paris Descartes (n=109) Excluded from analysis (n=32) Included in sensitivity analysis (n=176)
ACCEPTED MANUSCRIPT Highlights
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In this two-site randomized controlled trial that included 352 medical students, selfreported empathy at follow-up was significantly higher among the intervention group (i.e. students who participated to seven Balint group sessions) than the control group. The effect of the intervention on empathy as rated by standardized patients was significant in male participants only. The use of Balint groups may promote empathy among medical students.
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Céline Buffel du Vaure, Cédric Lemogne, Lucie Bunge, Annie Catu-Pinault, Nicolas Hoertel, Christian Ghasarossian, Marie-Eve Vincens, Eric Galam, Philippe Jaury PII: DOI: Reference:
S0022-3999(17)30759-6 doi:10.1016/j.jpsychores.2017.10.008 PSR 9423
To appear in:
Journal of Psychosomatic Research
Received date: Revised date: Accepted date:
12 June 2017 15 October 2017 15 October 2017
Please cite this article as: Céline Buffel du Vaure, Cédric Lemogne, Lucie Bunge, Annie Catu-Pinault, Nicolas Hoertel, Christian Ghasarossian, Marie-Eve Vincens, Eric Galam, Philippe Jaury , Promoting empathy among medical students: A two-site randomized controlled study. The address for the corresponding author was captured as affiliation for all authors. Please check if appropriate. Psr(2017), doi:10.1016/j.jpsychores.2017.10.008
This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT Promoting Empathy among medical students: a two-site randomized controlled study
Céline Buffel du Vaurea,b,* MD, PhD; Cédric Lemognec,d,e, MD, PhD; Lucie Bungef MD; Annie Catu-Pinaulta,g MD; Nicolas Hoertelc,d,e MD; Christian Ghasarossiana MD, Professor;
a
Université Paris Descartes, Sorbonne Paris Cité, Faculté de Médecine, Département de Médecine
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Générale, 24 rue du Faubourg Saint Jacques, 75014, Paris, France
METHODS Team, Epidemiology and Statistics Sorbonne Paris Cité, Research Center UMR 1153,
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b
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Marie-Eve Vincensg,h MD; Eric Galamf MD, Professor; Philippe Jaurya,g MD, Professor
Inserm, 1 place du parvis de Notre Dame, 75004, Paris, France
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d
Université Paris Descartes, Sorbonne Paris Cité, Faculté de Médecine, Paris, France AP-HP, Hôpitaux Universitaires Paris Ouest, Service de Psychiatrie de l’adulte et du sujet âgé, 20
Rue Leblanc, 75015, Paris, France e
Inserm,
U894,
Centre
f
Psychiatrie
et
Neurosciences,
2
ter,
rue
d'Alésia
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75014, Paris, France
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c
Université Paris Diderot, Sorbonne Paris Cité, Faculté de Médecine, Département de Médecine
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Générale, 16 rue Henri Huchard 75018, Paris, France Société Médicale Balint, 10 Route de Thionville, 57140 Woippy, France
h
Université Paris 13, Sorbonne Paris Cité, Département de Médecine Générale, 74 rue Marcel Cachin
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g
93017, Bobigny Cedex, France
Word count : 2919
* Corresponding author: Dr Céline Buffel du Vaure Département de Médecine Générale, Faculté de Médecine Paris Descartes 24 rue du Faubourg Saint Jacques, 75014 PARIS, France tel 0033 144412363 [email protected]
ACCEPTED MANUSCRIPT Abstract Objective: To assess the effects of Balint groups on empathy measured by the Consultation And Relational Empathy Measure (CARE) scale rated by standardized patients during objective structured clinical examination and self-rated Jefferson’s School Empathy Scale Medical Student (JSPE-MS©) among fourth-year medical students.
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Methods: A two-site randomized controlled trial were planned, from October 2015 to
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December 2015 at Paris Diderot and Paris Descartes University, France. Eligible students
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were fourth-year students who gave their consent to participate. Participants were allocated in equal proportion to the intervention group or to the control group. Participants in the
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intervention group received a training of 7 sessions of 1.5-hour Balint groups, over 3 months. The main outcomes were CARE and the JSPE-MS© scores at follow-up.
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Results: Data from 299 out of 352 randomized participants were analyzed: 155 in the intervention group and 144 in the control group, with no differences in baseline measures.
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There was no significant difference in CARE score at follow-up between the two groups
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(P=0.49). The intervention group displayed significantly higher JSPE-MS© score at followup than the control group [Mean (SD): 111.9 (10.6) versus 107.7 (12.7), P=0.002]. The JSPEMS© score increased from baseline to follow-up in the intervention group, whereas it
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decreased in the control group [1.5 (9.1) versus -1.8 (10.8), P=0.006]. Conclusions: Balint groups may contribute to promote clinical empathy among medical students.
Trial Registration: NCT02681380 Word count for abstract: 222
ACCEPTED MANUSCRIPT Introduction
Empathy can be defined as the ability to share and/or understand others’ emotional state without confusion between self and others. Clinical empathy, i.e. empathy within the context of a doctor-patient relationship, is considered as a core feature of the doctor-patient 1,2
, as acknowledged by most of medical schools. For instance, the Association of
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relationship
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American Medical Colleges states that “physicians must be compassionate and empathetic in
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caring for patients”.3 Results of several observational studies have shown that doctors’ empathic abilities are associated with better patient satisfaction, more accurate clinical
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assessment, better therapeutic alliance, which in turn may lead to better compliance and better related medical outcomes with diminished costs.1 Unfortunately, several cross-sectional and
during medical training
4–6
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longitudinal studies have documented a weak, yet significant decline of the empathic abilities .
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Several controlled interventions have attempted to promote empathic abilities among
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already certified physicians 1. Since clinical empathy also encompasses the physician’s ability to communicate his or her understanding of the emotional state of the patient, most of these interventions targeted communication skills
7
. When evaluated by the patient (either real or
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simulated), these interventions have shown significant, but small effect size 7. In the context of medical school, several interventions have been proposed to promote medical students’ empathic abilities such as narrative medicine groups
11
, videotaped case analyses
12
8,9
, theatre groups
or Balint groups
10
13
, experience sharing in small
. However, none of these
interventions have been evaluated using a randomized controlled design. A preliminary non-randomized comparative study by our group suggested that Balint groups may be efficient in enhancing empathic reactions measured on specifically designed case-reports
13
. Balint groups are specifically designed to help health-professionals and
ACCEPTED MANUSCRIPT medical students in developing their empathy skills to reduce interpersonal difficulties while taking into account emotional issues
14–16
. These interventions differ from problem-based
learning because they aim to develop empathic abilities rather than medical knowledge
17
.
Based on our preliminary report, the present study aims to assess the efficacy of Balint groups in improving empathy measured by the Consultation And Relational Empathy Measure
Examination (OSCE) Student (JSPE-MS©)
by
standardized
patients
during
Objective
Structured
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rated
Clinical
18
and the self-rated Jefferson’s School Empathy Scale - Medical
5
among fourth-year medical students, in a two-site randomized
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scale
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(CARE)
controlled trial. We also aimed to examine the potential moderating role of site, gender or
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baseline empathy on this intervention.
ACCEPTED MANUSCRIPT Methods
Design We planned a two-site parallel-group randomized controlled trial assessing the efficacy of Balint groups versus control on clinical empathy among fourth-year medical
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students.
Paris,
France
(number
00001072),
and
the
protocol is
registered
at
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University,
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The study obtained ethics approval from the Institutional Review Board of Paris Descartes
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ClinicalTrials.gov (NCT02681380).
Setting and Participants
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The study was conducted from October 2015 to December 2015 at Paris Diderot and Paris Descartes University (Paris, France). Eligible students were fourth-year medical
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students who gave their consent to participate through a secured website. At Paris Diderot, the study was proposed to a random sample of 140 students. At Paris Descartes, in which the
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fourth-year curriculum includes three mandatory consecutive 3-month learning programs in random order, the study was proposed to two thirds of the students (N=262), according to the
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program they had to follow first (see below). There were no exclusion criteria.
Randomization
Eligible students were allocated in equal proportion to the intervention group or to the control group. Students from Paris Diderot were randomized with a simple randomization using computer-generated random numbers. Among students from Paris Descartes, we took advantage of the randomization routinely performed each year by the University staff to allocate each student to one of three groups, each corresponding to a particular order of the
ACCEPTED MANUSCRIPT three mandatory 3-month programs of the fourth-year curriculum. During the study interval, one of these programs included Balint groups as the only teaching related to clinical empathy. The participants who followed this program first were considered as the intervention group. Another 3-month program did not include such specific teaching. The participants who followed this program first were considered as the control group. The third 3-month program
8,9
.
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have effects on empathy
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was not included in this study because it included narrative medicine teachings that could
Intervention
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Regardless of the site, the students in the intervention group were randomly split into groups of 12 or 13 students. Each group received a training over 2 months that included 7
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weekly 1.5-hour Balint group sessions. Participants in Balint groups were asked to react to a particularly touching, upsetting or interesting live clinical situation that involves interpersonal 13
. This training was not specifically
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problems, under the supervision of a trained facilitator
tailored to improve empathy and did not differ from usual Balint group sessions. Before the
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beginning of the study, all the facilitators were accredited as Balint groups’ leaders either by the French Balint Medical Society (Société Médicale Balint France) or the Balint Training
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Association (Association de Formation Balint). To homogenize the intervention, regular meetings among facilitators were organized before and during the study. Students included in the control group received no specific training.
Procedure Baseline characteristics were self-reported and included gender, site (Paris Diderot University or Paris Descartes University), education level of the most educated parent (primary / secondary, undergraduate or graduate / postgraduate), living status (alone, with
ACCEPTED MANUSCRIPT parents, as couple, or other), anticipated specialty choice (anesthesia/emergency/intensive care, surgery, medicine, psychiatry or non-clinical specialty)
19
. In addition, all participants
had to complete the validated French version of the JSPE-MS©
20
at baseline through a
secured website. This scale encompasses 20 items Likert-type items, rated from 1 (strongly disagree) to 7 (strongly agree) (e.g. “Patients feel better when their physicians understand
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their feelings”), leading to a summed score ranging from 20 to 140 with higher score
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indicating higher levels of empathy.
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One week after the last Balint group session, all intervention and control group participants had to complete the JSPE-MS© again and then participate in two sessions of
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patient simulation during OSCE of 15 minutes. Standardized patients were simulated by actors. An observer was present during all sessions. Scenarios were designed by a panel of
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experts that inclued 4 general practitioners and 1 psychiatrist. Two fictive cases were constructed: one case regarding announcement of HIV status and one case regarding
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inappropriate demand of antibiotic delivery. No physical examination was requested.
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Standardized patients fulfilled the CARE scale immediately after each OSCE (i.e. two measures). The CARE scale is a 10-item patient-rated questionnaire of physician empathy [e.g. “How good was the practitioner at showing care and compassion (seeming genuinely
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concerned, connecting with you on a human level; not being indifferent or detached)?”]
21
.
Each item can be scored on a Likert scale from 1 (poor) to 5 (excellent), with a ‘does not apply’ option, leading to a summed score ranging from 10 to 50 with higher score indicating higher levels of empathy.
Blinding Whereas students and facilitators were aware of the allocated group, standardized patients, OSCE’s observers and data analysts were kept blinded to the allocation.
ACCEPTED MANUSCRIPT
Statistical analysis Primary outcomes were the mean CARE score (across both scenarios) and the JSPEMS© score at follow-up. Secondary outcome was the change in JSPE-MS© score from baseline to follow-up.
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Based on a literature-driven hypothesis of a 4-point between-group difference with a
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SD of 12 points regarding the JSPE-MS© score 4 , we calculated that 144 participants per
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group were needed to ensure a significance level of 5% and a power of 80%. With an estimation of 10% of missing data, we decided to approach 160 participants per group
22
.
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Because of a technical problem, data were systemically missing for one item (i.e. “Physicians should try to stand in their patients’ shoes when providing care to them”) of the
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JSPE-MS©. However, the internal consistency in our sample was good (Cronbach’s alpha: 0.77 and 0.80 for the baseline and follow-up measures, respectively) and thus allowed
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computing a one-dimension global score based on the mean item value multiplied by 20. Likewise, the internal consistency of the CARE scale was excellent (Cronbach’s alpha: 0.95
apply’ answers).
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for both scenarios), allowing similar computation for missing data (including few ‘does not
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Descriptive results were reported with means and SDs for quantitative variables or absolute frequencies and percentages by modality for qualitative variables. Between-group differences regarding the covariates and the outcome measures were tested with Student’s ttest for continuous variables and Chi-square tests for categorical variables. Statistical significance was evaluated using a two-sided design with alpha set a priori at 0.05. Exploratory analyses aimed at looking for a moderating effect of site, gender and baseline JSPE-MS© score. Whenever an interaction between group and one of these factors (including
ACCEPTED MANUSCRIPT the group, the factor and the interaction term in a general linear model) was found, stratified analyses were performed. Sensitivity analyses relied on a general linear model to adjust the results for participants’ characteristics that tend to differ between the intervention and the control group with a p-value < 0.10. Finally, for participants who were allocated to one group but who did
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not complete the empathy assessment, we used their JSPE-MS© score at baseline as the
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JSPE-MS© score at follow-up.
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All statistical analyses were computed using SPSS 16.0.1 software (SPSS Inc.,
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Chicago, IL, USA).
ACCEPTED MANUSCRIPT Results
Participants Among the 352 students who were allocated to either the intervention or the control group, 53 did not participate to the OSCE or did not complete the JSPE-MS© at follow-up.
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This resulted in a final sample of 299 participants, including 155 in the intervention group and
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144 in the control group (Figure 1 – Flow diagram). There was no significant difference
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regarding participants’ characteristics and group allocation between these 299 participants and the 53 students who did not complete the empathy assessment (Supplemental Table 1).
Empathy measures at follow-up
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JSPE-MS© score at baseline (Table 1).
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The two groups did not differ regarding sociodemographic factors, specialty choice or
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Table 2 displays CARE and JSPE-MS© scores at follow-up and changes in JSPEMS© scores from baseline to follow-up, according to the group. There was no significant
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difference in mean CARE score at follow-up between the two groups (P=0.49). The intervention group participants displayed a significantly higher mean JSPE-MS© score at
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follow-up than the participants from the control group [mean (SD): 111.9 (10.6) versus 107.7 (12.7), t=3.08, P=0.002]. The mean JSPE-MS© score increased from baseline to follow-up among the intervention group, whereas it decreased among the control group [1.5 (9.1) versus -1.8 (10.8), t=2.79, P=0.006].
Exploratory analyses Regarding the CARE score, the group by site interaction was not significant (P=0.348) but the group by gender interaction and the group by baseline JSPE-MS© median split
ACCEPTED MANUSCRIPT interaction were both significant (P=0.007 and P=0.035, respectively). Stratified analyses by gender showed higher CARE scores among the intervention (versus control) group for men [66.3 (15.9) versus 59.4 (12.6), t=2.67, P=0.009] but not among women [60.9 (16.7) versus 63.7 (13.9), t=1.18, P=0.241]. Stratified analyses according to the baseline JSPE-MS© median score showed higher CARE scores in the intervention (versus control) group among
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the participants with a score above the median [67.1 (17.1) versus 62.1 (13.9), t=1.99,
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P=0.048], but not among those with a score below the median [59.7 (15.2) versus 62.0 (13.4),
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t=1.00, P=0.321].
Regarding the JSPE-MS© score at follow-up or the change in JSPE-MS© score from
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baseline to follow-up, the group by site and group by gender interactions were not significant (all P≥0.356), which prevented further stratified analyses.
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Among the intervention group, there was no significant difference in JSPE-MS© scores at follow-up between participants who attended 7 sessions [112.6 (9.9), N=82], 6
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Sensitivity analyses
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sessions [111.2 (10.0), N=52] or only 3 to 5 sessions [110.7 (14.4), N=21] (F=0.43, P=652).
Adjusting our results for participants’ characteristics that tend to differ between the
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intervention and the control group in a general linear model (i.e. gender, parents’ education level and specialty choice) yielded similar results regarding both the mean JSPE-MS© score at follow-up [estimated mean (standard error): 112.6 (2.1) versus 108.4 (2.1), F=9.37, P=0.002] and the changes in mean JSPE-MS© score from baseline to follow-up [estimated mean (standard error): 2.8 (1.8) versus -0.6 (1.8), F=7.96, P=0.005]. Finally, we included the 53 students who did not complete the empathy assessment, using their JSPE-MS© score at baseline as the JSPE-MS© score at follow-up. This sensitivity analysis yielded similar results, the intervention group displaying higher JSPE-MS© score at
ACCEPTED MANUSCRIPT follow-up than the control group [mean (SD): 111.2 (11.0) versus 107.7 (12.6), t=2.68, P=0.008] and the JSPE-MS© score increased from baseline to follow-up among the intervention group and decreased from baseline to follow-up among the control group [1.2
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(9.0) versus -1.2 (11.2), t=2.16, P=0.031].
ACCEPTED MANUSCRIPT Discussion
The present study aimed to use a randomized controlled design to test the efficacy of an intervention based on the use of Balint groups to promote empathy among medical students. Compared to a control group, the intervention showed increased levels of self-
empathy was consistent across site,
gender and baseline empathy levels.
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reported
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reported empathy and similar levels of externally evaluated empathy. This effect on self-
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Furthermore, exploratory analyses found some support for a positive effect of the intervention on externally evaluated empathy among men as well as among participants having the highest
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levels of self-reported empathy at baseline. Finally, sensitivity analyses showed that these results were robust.
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To our knowledge, this is the first experimental study to examine the efficacy of an intervention aimed at promoting empathy during medical school. This study has several
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strengths, including its two-site randomized controlled design and the use of both self-report and externally assessed measures of empathy. Since empathy is critically modulated by 23
, it is noteworthy that these two measures focused on empathy in the
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contextual factors
context of the doctor-patient relationship. Indeed, our preliminary study found no group
13
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differences with a less specific measure of empathy such as the Interpersonal Reactivity Index . The similar effect observed at the two sites provides some support to the possible
reliability and generalization of the intervention to other settings. Because 85% of the students in the intervention group missed no more than one of the seven sessions we could not show a significant association between Balint group attendance and changes in self-reported empathy, but this suggests that this intervention is well-accepted. Additionally, the weak, yet significant decline in self-reported empathy observed among the control group is consistent with the literature
4–6
, and this also provides some support to the external validity of the present study.
ACCEPTED MANUSCRIPT Some limitations should be acknowledged. First, one could argue that the effect size of the intervention was rather small and could be of limited duration after the end of the training. However, this effect was observed over 2 months only whereas Balint groups are meant to be implemented over a longer period of time. Further studies might examine whether longer exposure to Balint groups, as recommended, may result in greater effect size, and whether
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sustained effects could be observed in the long run. Second, the two groups in Paris Descartes
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University also differed regarding the exposure to other learning programs (i.e. cardiology,
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respiratory medicine and intensive care medicine for the control group versus orthopedic surgery, rheumatology and dermatology for the intervention group). However, none of these specifically
relates
to
empathy or doctor-patient relationship.
Furthermore,
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programs
exploratory analyses found no support for a moderating effect of site, suggesting that the
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effect of the intervention was not driven by one university only. The intervention tested in the present study might be more efficient for self-reported
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empathy than externally assessed empathy. Externally assessed empathy might focus more on the students’ ability to communicate his or her understanding of the emotional state of the
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patient than on this understanding per se. In other words, the intervention could have fostered students’ empathy while failing to improve the communication skills needed to improve
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perceived empathy.
Several explanations could account for the effects observed on self-reported empathy. First, it could result from increased social desirability of empathy rather than from increased empathic abilities per se. Such interpretation would indeed be consistent with the fact that promoting the value of empathy in the context of doctor-patient relationship is at the core of the intervention. Empathic abilities are useless if they are not actually implemented in clinical practice and the so-called decline of empathy during medical school is more likely to be a decline of the perceived value of empathy, as captured by the majority of the JSPE-MS©
ACCEPTED MANUSCRIPT items13,24,25 . Most of the accounts of this decline build on the value given to empathy (e.g. by significant models such as senior physicians
26
), rather than on empathic abilities per se. Other
factors may contribute to this phenomenon such as teaching methods
27
(e.g. prioritizing a
purely biomedical approach), selection procedures which may not favor the most empathic students
28
or coping strategies based on emotional distancing
29
. Second, beside the
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promotion of empathy as a value shared by the medical community, the use of Balint groups
14,30
. For instance, perspective-taking may protect
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emotions elicited by clinical practice
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may also decrease self-distancing by providing medical students with other tools to regulate
physicians from such detrimental effects while allowing them to show sustained empathic 31
.
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concern
The present results also suggest that men and participants with higher levels of
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baseline self-reported empathy may be more prone to take advantage of the intervention to increase their communication skills, as assessed by a simulated patient during an OSCE.
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These results might sound contradictory as men usually displayed lower levels of self-
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reported empathy. Women might have been less sensitive to the intervention as a result of a ceiling effect whereas participants with higher levels of JSPE-S scores might have been more prone to take an active part during Balint groups.
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In conclusion, the results of the present study provide the initial evidence of the efficacy of Balint groups to promote the humanistic value of empathy among medical students. Further studies should attempt to determine whether some subgroups, such as men in the current study, are more likely to benefit from such intervention. This intervention should also be tested against other types of intervention aimed at promoting empathy, such as narrative medicine
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ACCEPTED MANUSCRIPT References Kelm Z, Womer J, Walter JK, Feudtner C. Interventions to cultivate physician empathy: a systematic review. BMC Med Educ. 2014;14:219. doi:10.1186/1472-6920-14-219.
2.
Hemmerdinger JM, Stoddart SDR, Lilford RJ. A systematic review of tests of empathy in medicine. BMC Med Educ. 2007;7:24. doi:10.1186/1472-6920-7-24.
3.
Learning objectives for medical student education--guidelines for medical schools: report I of the Medical School Objectives Project. Acad Med J Assoc Am Med Coll. 1999;74(1):13-18.
4.
Neumann M, Edelhäuser F, Tauschel D, et al. Empathy decline and its reasons: a systematic review of studies with medical students and residents. Acad Med J Assoc Am Med Coll. 2011;86(8):996-1009. doi:10.1097/ACM.0b013e318221e615.
5.
Hojat M, Vergare MJ, Maxwell K, et al. The devil is in the third year: a longitudinal study of erosion of empathy in medical school. Acad Med J Assoc Am Med Coll. 2009;84(9):1182-1191. doi:10.1097/ACM.0b013e3181b17e55.
6.
Colliver JA, Conlee MJ, Verhulst SJ, Dorsey JK. Reports of the decline of empathy during medical education are greatly exaggerated: a reexamination of the research. Acad Med J Assoc Am Med Coll. 2010;85(4):588-593. doi:10.1097/ACM.0b013e3181d281dc.
7.
Moore PM, Rivera Mercado S, Grez Artigues M, Lawrie TA. Communication skills training for healthcare professionals working with people who have cancer. Cochrane Database Syst Rev. 2013;3:CD003751. doi:10.1002/14651858.CD003751.pub3.
8.
Charon R, Wyer P, NEBM Working Group. Narrative evidence based medicine. Lancet Lond Engl. 2008;371(9609):296-297.
9.
Goupy F, Abgrall-Barbry G, Aslangul E, et al. [Can narrative medicine be an answer to patient physician relationship teaching according to students’ demand in medical education curricula?]. Presse Médicale Paris Fr 1983. 2013;42(1):e1-8. doi:10.1016/j.lpm.2012.09.012.
10.
Dow AW, Leong D, Anderson A, Wenzel RP, VCU Theater-Medicine Team. Using theater to teach clinical empathy: a pilot study. J Gen Intern Med. 2007;22(8):1114-1118. doi:10.1007/s11606-007-0224-2.
11.
Branch WT, Pels RJ, Hafler JP. Medical students’ empathic understanding of their patients. Acad Med J Assoc Am Med Coll. 1998;73(4):360-362.
12.
Suchman AL, Markakis K, Beckman HB, Frankel R. A model of empathic communication in the medical interview. JAMA. 1997;277(8):678-682.
13.
Airagnes G, Consoli SM, De Morlhon O, Galliot A-M, Lemogne C, Jaury P. Appropriate training based on Balint groups can improve the empathic abilities of medical students: a preliminary study. J Psychosom Res. 2014;76(5):426-429. doi:10.1016/j.jpsychores.2014.03.005.
14.
Freyberger H, Besser L. Teaching psychosomatic medicine with special reference to the Balint group and the case supervision group. Psychother Psychosom. 1982;38(1):239-243.
15.
Torppa MA, Makkonen E, Mårtenson C, Pitkälä KH. A qualitative analysis of student Balint groups in medical education: contexts and triggers of case presentations and discussion themes. Patient Educ Couns. 2008;72(1):5-11. doi:10.1016/j.pec.2008.01.012.
AC C
EP T
ED
MA
NU
SC
RI
PT
1.
ACCEPTED MANUSCRIPT Van Roy K, Vanheule S, Inslegers R. Research on Balint groups: A literature review. Patient Educ Couns. 2015;98(6):685-694. doi:10.1016/j.pec.2015.01.014.
17.
Neville AJ. Problem-based learning and medical education forty years on. A review of its effects on knowledge and clinical performance. Med Princ Pract Int J Kuwait Univ Health Sci Cent. 2009;18(1):1-9. doi:10.1159/000163038.
18.
Brannick MT, Erol-Korkmaz HT, Prewett M. A systematic review of the reliability of objective structured clinical examination scores. Med Educ. 2011;45(12):1181-1189. doi:10.1111/j.13652923.2011.04075.x.
19.
Rotge J-Y, Lemogne C, Jouvent R, Fossati P. Relationship between personality dimensions and medical specialty in 1661 residents. J Psychosom Res. 2015;79(4):331-332. doi:10.1016/j.jpsychores.2015.06.009.
20.
Alexandre Bitoun. Validation du score JSPE-Medical Student© en langue française dans l’évaluation de l’empathie des étudiants en médecine (MD dissertation). February 2017.
21.
Mercer SW, Maxwell M, Heaney D, Watt GC. The consultation and relational empathy (CARE) measure: development and preliminary validation and reliability of an empathy-based consultation process measure. Fam Pract. 2004;21(6):699-705. doi:10.1093/fampra/cmh621.
22.
Norman G, Streiner D. PDQ Statistics. London. London: BC Decker Inc.; 1999.
23.
Decety J, Jackson PL. The functional architecture of human empathy. Behav Cogn Neurosci Rev. 2004;3(2):71-100. doi:10.1177/1534582304267187.
24.
Pedersen R. Empirical research on empathy in medicine-A critical review. Patient Educ Couns. 2009;76(3):307-322. doi:10.1016/j.pec.2009.06.012.
25.
Lemogne C. [EMPATHY IN MEDICINE, NECESSARY BUT NOT FREE FROM RISKS]. Rev Prat. 2015;65(8):1027-1030.
26.
Newton BW, Barber L, Clardy J, Cleveland E, O’Sullivan P. Is there hardening of the heart during medical school? Acad Med J Assoc Am Med Coll. 2008;83(3):244-249. doi:10.1097/ACM.0b013e3181637837.
27.
Garden R. Expanding clinical empathy: an activist perspective. J Gen Intern Med. 2009;24(1):122-125. doi:10.1007/s11606-008-0849-9.
28.
Chen DCR, Kirshenbaum DS, Yan J, Kirshenbaum E, Aseltine RH. Characterizing changes in student empathy throughout medical school. Med Teach. 2012;34(4):305-311. doi:10.3109/0142159X.2012.644600.
29.
Halpern J. What is clinical empathy? J Gen Intern Med. 2003;18(8):670-674.
30.
Turner AL, Malm RL. A preliminary investigation of balint and non-balint behavioral medicine training. Fam Med. 2004;36(2):114-122.
31.
Gleichgerrcht E, Decety J. Empathy in clinical practice: how individual dispositions, gender, and experience moderate empathic concern, burnout, and emotional distress in physicians. PloS One. 2013;8(4):e61526. doi:10.1371/journal.pone.0061526.
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ACCEPTED MANUSCRIPT Acknowledgments We thank the Jefferson Medical College for their permission to use the French version of the JSPE-MS© scale. We thank Gérard Friedlander, Benoit Schlemmer and Jean-Luc Dumas for having authorized the implementation of the study, Antoine Tesnière for having reviewed the project at
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University Paris Descartes, François Goupy for his help in managing the web-based data
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collection and Jacques Blacher for the implementation of the OSCEs at Hôtel-Dieu Hospital
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(Paris, France). We also thank the facilitators of the Balint groups (Françoise Auger, Martine Fabre, Joëlle Lehmann, Marie-Anne Puel, Pascale Hauvespre, Louis Velluet). We are
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particularly indebted to Louis Velluet for having developed Balint groups for medical students in France. Finally, we thank the actors involved in the OSCEs as well as the residents
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involved in the implementation of the OSCEs. Funding
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This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
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Competing interest declaration
None of the authors has any financial conflict of interests to report.
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Authors’ contributions
All authors participated in the conception and design of the study and to the collected of the data. CL performed the statistical analysis. All authors interpreted the results. CL and CBV drafted the manuscript and all authors revised the manuscript critically for important intellectual content. All authors read and approved the final version of the manuscr ipt. Transparency declaration
ACCEPTED MANUSCRIPT PJ affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; no important aspects of the study have been omitted; and that any discrepancies from the study as planned have been explained. Data sharing statement
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Data sharing: no additional data available.
ACCEPTED MANUSCRIPT Table 1. Participants’ characteristics at baseline according to group allocation Intervention group (N=155) N %
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4 11 140
2.6 7.1 90.3
46 73 16 18 2
94 50
29.7 47.1 10.3 11.6 1.3
109 35
75.7 24.3
11 6 127
7.6 4.2 88.2
34 73 12 21 4
χ2 3.81
P 0.051
0.05
0.826
4.97
0.083
2.03b
0.566b
8.36
0.079
65.3 34.7
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76.8 23.2
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Parental education level a Primary / secondary Undergraduate Graduate / postgraduate Living status Alone With parents As couple Other Missing Specialty choice Anesthesia/emergency/intensive care Surgery Medicine Psychiatry Non-clinical specialty Balint groups attendance 7 sessions 6 sessions 3-5 sessions
119 36
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Site Paris Descartes University Paris Diderot University
54.2 45.8
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84 71
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Gender Female Male
Control group (N=144) N %
23.6 50.7 8.3 14.6 2.8
12 21 115 7 0
7.7 13.5 74.2 4.5 0.0
8 28 105 1 2
5.6 19.4 72.9 0.7 1.4
82 52 21 Mean
52.9 33.5 13.5 SD
Mean
SD
t
P
11.8 11.7 12.1
0.60 0.49 0.74
0.547 0.624 0.464
JSPE-MS© score Full sample 110.3 10.2 109.5 Female 111.4 10.6 110.6 Male 109.0 9.7 107.6 a education level of the most educated parent b after exclusion of the missing data JSPE-MS©: Jefferson Scale of Physician Empathy for Medical Students
ACCEPTED MANUSCRIPT Table 2. Post-intervention empathy measures.
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Intervention group Control group (N=155) (N=144) Mean SD Mean SD CARE scores at follow-up 63.4 16.5 62.2 13.6 JSPE-MS© score at follow-up 111.9 10.6 107.7 12.7 a Change in JSPE-MS© score 1.5 9.1 -1.8 10.8 CARE: Consultation And Relational Empathy Measure JSPE-MS©: Jefferson Scale of Physician Empathy for Medical Students a from baseline to follow-up
t 0.69 3.08 2.79
P 0.488 0.002 0.006
ACCEPTED MANUSCRIPT Figure 1. Flow diagram
Assessed for eligibility (n=402) Paris Diderot (n=140) Paris Descartes (n=262)
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Enrollment
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Excluded (n=50) Declined to participate (n=50)
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Randomized (n=352) Paris Diderot (n=90) Paris Descartes (n=262)
Allocation
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Allocated to intervention (n=176) Paris Diderot (n=45) Paris Descartes (n=131)
Follow-Up
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Lost to follow-up (n=21) Did not attended at least 1 session (n=5) Lack of assessment at follow-up (n=16)
Analysed (n=155) Paris Diderot (n=36) Paris Descartes (n=119) Excluded from analysis (n=21) Included in sensitivity analysis (n=176)
Allocated to control (n=176) Paris Diderot (n=45) Paris Descartes (n=131)
Lost to follow-up (n=32) Lack of assessment at follow-up (n=32)
Analysis Analysed (n=144) Paris Diderot (n=35) Paris Descartes (n=109) Excluded from analysis (n=32) Included in sensitivity analysis (n=176)
ACCEPTED MANUSCRIPT Highlights
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In this two-site randomized controlled trial that included 352 medical students, selfreported empathy at follow-up was significantly higher among the intervention group (i.e. students who participated to seven Balint group sessions) than the control group. The effect of the intervention on empathy as rated by standardized patients was significant in male participants only. The use of Balint groups may promote empathy among medical students.
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