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Positive impact of simulation training of residents on the patients’ psychological experience following pregnancy loss
G Model JOGOH 101650 No. of Pages 6
Journal of Gynecology Obstetrics and Human Reproduction xxx (2019) xxx–xxx
ScienceDirect
Original Article
Positive impact of simulation training of residents on the patients’ psychological experience following pregnancy loss C. Verhaeghea , M. Gicquela , P.E. Boueta , R. Corroennea , P. Descampsa , G. Legendrea,b,* a b
Service de Gynécologie-Obstétrique, CHU Angers, 49933 Angers Cedex, France CESP-INSERM, U1018, Equipe 7, Genre, Santé Sexuelle et Reproductive, Université Paris Sud, 94276 Villejuif, France
A R T I C L E I N F O
A B S T R A C T
Article history: Received 20 July 2019 Received in revised form 2 November 2019 Accepted 4 November 2019 Available online xxx
Objective: Our study aimed to assess the impact of a simulation training program for residents for the disclosure of diagnosis on the psychological experience of couples following a first trimester pregnancy loss (PL). Methods: We performed an uncontrolled prospective single center, before-after study, at the gynecological emergency department of Angers University Hospital in France, between May 2014 and April 2015. We included all patients who had a confirmed diagnosis of first trimester PL. A selfadministering questionnaire (SAQ) that included the short version of the perinatal grief scale (PGS) and questions about the couples’ personal experience was sent by mail 8 weeks after the diagnosis. Patients were included before and after simulation training of the residents on the communication of the diagnosis of PL, and scores were compared between the two groups (before and after training). Results: Overall 72 patients fulfilled the inclusion criteria and responded to the SAQ, 45 before and 27 after simulation training. Overall, simulation training significantly lowered the overall PGS (39.4 4.9 vs 57.3 5.6, p = 0.03), significantly improved the attitude of the resident when announcing the diagnosis (more considerate (74.1 % vs 48.9 %, p = 0.04) and available (59.3 % vs 28.9 %, p = 0.01)), and significantly improved the quality of the information given (less incomprehensible (22.2 % vs 46.7 %, p = 0.04). Finally, significantly fewer patients reported needing an additional consultation for further information following training (33.3 % vs 73.3 %, p = 0.01). Conclusion: Simulation training of residents for the disclosure of early pregnancy loss significantly improves the couples’ personal experience and decreases the psychological morbidity associated with the communication. © 2019 Published by Elsevier Masson SAS.
Keywords: Simulation Training Pregnancy loss Miscarriage Perinatal grief scale
Introduction First trimester pregnancy loss (PL), also known as early pregnancy loss (EPL), spontaneous abortion, or miscarriage, refers to the loss of a clinical pregnancy before 14 weeks gestational age (GA) [1,2]. Its incidence is estimated between 10 and 15 %, and it increases with maternal age [3,4]. EPL can have important psychological consequences for the woman, her partner, and the couple [5]. Indeed, following EPL, women have reported feelings of grief, guilt, hopelessness, and anxiety (20–40 %) [6–8], while depression has been reported to affect up to 50 % of patients [9–11]. Moreover, studies have reported a temporary increase in anxiety, depression and post-traumatic stress levels in women during the
* Corresponding author at: Service de Gynécologie-Obstétrique, Centre Hospitalier Universitaire d’Angers, 4 rue Larrey, 49033 Angers Cedex 01, France. E-mail address: [email protected] (G. Legendre).
first trimester of the ensuing pregnancy following an EPL [12]. Fortunately, most of these feelings are transient, and the majority of patients resume their normal lives within one year [12]. However, some of these emotions, if not dealt with correctly, could impact the course of future pregnancies, with some studies reporting a consequently increased risk of recurrence [11–13]. The disclosure of a diagnosis of pregnancy loss is an essential aspect of the initial management, and several studies have confirmed the impact of the physician’s attitude when announcing the diagnosis on the couple’s well-being [12,14,15]. Unfortunately, not all physicians are aware of the importance of their comportment – which can be affected by several factors, some dependent and others completely independent of the physician and the consequences it can have on the couple’s personal experience. In France, most diagnoses of EPL are made in the gynecologic emergency departments, and are handled by residents in training, which can lead to less than adequate disclosures and thus leave the couples with a bad experience [16]. Physicians and
http://dx.doi.org/10.1016/j.jogoh.2019.101650 2468-7847/© 2019 Published by Elsevier Masson SAS.
Please cite this article in press as: C. Verhaeghe, et al., Positive impact of simulation training of residents on the patients’ psychological experience following pregnancy loss, J Gynecol Obstet Hum Reprod (2019), https://doi.org/10.1016/j.jogoh.2019.101650
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residents should take into consideration the sensitivity of the situation, and take their time to adequately address and give the proper information to the patients and their partners. Since Obstetrics and Gynecology residents are frequently exposed to these situations, it is important they get the appropriate training in order to adequately handle and counsel the couples. Nowadays, simulation training plays an important role in residents’ cursus and training, and is currently being used to help residents communicate difficult news to patients and family members [17]. However, to this date, it has not been used in the setting of disclosure of the diagnosis of early pregnancy loss. Therefore, we undertook a prospective study to assess the impact of a simulation based training program for residents on the couples’ personal experience following confirmation of an EPL in the emergency department. Materials and methods Patients We undertook an uncontrolled prospective single center, before-after study, at the gynecological emergency department of Angers University Hospital in France, between May 2014 and April 2015. All patients presenting to the emergency department with the suspicion of an EPL – defined as PL before 14 weeks gestational age (GA) – were candidates for inclusion. They were identified using the emergency departments admission logs. The study was approved by the Angers University Hospital ethics committee. The exclusion criteria were: Pregnancies achieved with Assisted Reproductive Technologies (ART), since this is a different patient population with different risk factors. Unintended and unwanted pregnancies (achieved despite contraception, or requesting abortion). Patients with a third consecutive first trimester pregnancy loss. Patients with a positive obstetrical history (intra uterine fetal demise, recurrent late miscarriages . . . ). Patients undergoing psychological or psychiatric evaluation or treatment, or using psychotropic medications. Non-French speaking patients. Minor patients (<18 years). Cases where the disclosure of the pregnancy loss was made by the attending physician or the patient’s gynecologist. Cases where the communication was made by a resident who did not attend the training courses.
Intervention All patients were handed an information letter and signed an informed consent before being included in the study. A selfadministering questionnaire (SAQ) was sent by mail 8 weeks after the diagnosis of EPL in the emergency department. The SAQ included two sections: 1) Section one is the short version of the perinatal grief scale (PGS), originally developed by Potvin, Lasker and Toedter (1989), and translated to French (the French version was validated in 2000) [16]. It includes 33 questions, each scored from 1 to 5, distributed into three subscales. The first subscale, active grief, emphasizes the sadness and loss relative to the child. The second, difficulty coping, reflects the difficulty coping with routine activities and other activities, while the third, despair, reflects the lack of hope for a better future, associated with a feeling of worthlessness and guilt. A score is considered high
when greater than the mean added to its standard deviation. In our study, a score was considered high when greater than 42 for PGS-active grief, 30 for PGS-difficulty coping, and 27 for PGSdespair. 2) Section two included binary questions that covered several aspects. First of all, the couple’s medical history, in order to identify a possible exclusion criterion that was not listed in the patient’s medical records; Other questions, developed with the psychiatrists at our hospital, covered the attitude of the resident who examined the patient and confirmed the diagnosis to the couple, as well as the patients’ personal experience. There were also general questions about the cause of PL, the treatment administered, the short- and long-term follow-up, and whether a consultation with a psychologist was proposed following the confirmation of diagnosis. Finally, patients were asked whether all the relevant information was discussed and the important questions asked and answered, and whether another consultation was required later on to obtain additional information or to answer unresolved questions. The SAQ were sent before and after simulation training of the residents in charge of the emergency units. Training centered only around the communication of miscarriage, and was led by senior obstetricians/gynecologists from the Obstetrics and Gynecology department of Angers University Hospital, all instructors at the Angers simulation center. Each session was 3 h long, and included 3 pregnancy loss or threatened miscarriage disclosure scenarios. All simulation scenarios included the three conventional components: initial briefing, followed by clinical simulation and debriefing. The roles of the patients and their spouses were played by trained actors who regularly work in our simulation center, and who already had experience in the subject of communication in critical medical situations (newly diagnosed cancer, decision not to resuscitate . . . ). The simulation sessions took place “in situ” in the emergency department, where the real-life consultation occurs, and the participants watched via a live video transmission. The clinical scenarios resolved around patients consulting in the emergency department for metrorrhagia or pelvic pain during the first trimester, with the resident having to diagnose and disclose a threatened miscarriage or a pregnancy loss. There were several clinical contexts: recurrent pregnancy loss or first pregnancy, patients crying or completely mute, spontaneous pregnancy or via ART, medical or surgical treatment needed or no treatment required at all. The simulation sessions took place during two consecutive semesters. Two sessions of training were performed: one for the residents who were presents from May 2014 to October 2014 and the other one for the residents who were presents from November 2014 to April 2015. The training session was performed at the middle of each semester. During the first three months the residents performed the consultations without a specific training, during the last three months the same residents performed pregnancy loss announcement after training. At all six residents (3 for each semester) were involved. Statistical analysis The data collected from the SAQ and the medical records were anonymized. Patients who did not answer the survey were not sent any reminders or follow-ups, considering the sensitivity of the subject and the choice of some couples not to discuss the issue. Statistical analysis was performed using Stata 11.0 (Stata Corp., College Station. TX). Mean values and standard deviations (SD) were calculated for continuous variables and percentages for the categorical variables. Continuous variables were compared with Student’s t test, and categorical variables were compared with chisquare and Fisher’s exact test. A p value <0.05 was considered statistically significant.
Please cite this article in press as: C. Verhaeghe, et al., Positive impact of simulation training of residents on the patients’ psychological experience following pregnancy loss, J Gynecol Obstet Hum Reprod (2019), https://doi.org/10.1016/j.jogoh.2019.101650
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Results Overall, there were 6328 consultations recorded in the gynecological emergency department during the study period, out of which 1637 (25.5 %) were patients presenting in the first trimester with pelvic pain or metrorrhagia. There were 366 (22.4 %) confirmed diagnoses of pregnancy loss. 159 did not meet the inclusion criteria and were excluded before mailing the survey. 207 questionnaires were therefore sent and 115 patients responded (55.5 %). 43 patients were later excluded, and we ended up including 72 patients. 45 consultations occurred before the simulation training and 27 after. The inclusion and exclusion details are shown in the flowchart (Fig. 1). The characteristics of the patients are shown in Table 1. There were no significant differences in the general characteristics between patients included before or after the residents’ training. The results of the active grief scale survey before and after simulation training are shown in Table 2. Overall, the mean total score was 51.5 5.0, and was 21.7 8.2 for active grief, 15.8 6.6 for difficulty coping, and 16.3 6.4 for despair. Following simulation training, the overall score was significantly improved (39.4 4.9 vs 57.3 5.6, p = 0.03). Looking into the subscales, only the active grief scale was significantly reduced (18.8 6.7 versus 23.5 7.1, p = 0.03), whereas difficulty coping and despair were lower but statistically comparable (Table 2 The impact of simulation training on the patients’ impression and personal experience following the diagnosis is summarized in Table 3. Training significantly improved the attitude of the physician, with more patients reporting the physician was considerate (74.1 % vs 48.9 %, p = 0.04) and available (59.3 % vs 28.9 %, p = 0.01). However, there was no difference in the rate of patients who reported the communication as blunt or empathetic. Concerning the global information received, significantly fewer patients reported the information as incomprehensible following
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training (22.2 % vs 46.7 %, p = 0.04), but there was no difference in the rate of patients who found the information insufficient, awkward, or too technical. On the other hand, regarding the quality of the information given on the PL, significantly more patients reported that the information about short term care was understandable and complete following training (85.2 % vs 55.6 %, p = 0.01), but there was no significant difference for the cause of PL and the long-term care. Overall, a consultation with a psychologist was offered for a relatively few number of patients (15.3 %), and despite an increase following training, the difference did not reach statistical significance (8.8 % vs 26 %, p = 0.09). Finally, significantly fewer patients reported needing an additional consultation for further information following training (33.3 % vs 73.3 %, p = 0.01). Discussion To the best of our knowledge, our study is the first to assess the impact of simulation training of residents on the communication of the diagnosis of a first trimester pregnancy loss. Overall, we have found a significant improvement in the couples’ personal experience and a significant decrease in the psychological morbidity associated with the disclosure following training. Indeed, the attitude of the physician announcing the pregnancy loss was significantly improved, and the global perinatal grief score was significantly lower after training. Moreover, the information provided was more complete and easier to understand, with fewer patients requiring an additional consultation to address uncovered issues. Overall, we showed an objective improvement in the patients’ psychological morbidity following simulation training of the residents announcing the diagnosis, thus demonstrating a direct benefit of simulation training for patients. This direct impact of training is graded as level 4 in the Kirkpatrick model for training
Fig. 1. Flow chart.
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Table 1 Characteristics of the patients.
HISTORY Median age Work Smokers Alcohol use Gravidity Parity Number of children Nulliparous patients History of abortion CHARACTERISTICS AT THE TIME OF CONFIRMATION OF PREGNANCY LOSS Median gestational age (weeks) Reasons for consultation: Metrorrhagia Pelvic pain Referred following an ultrasound Expulsion mode Spontaneous Medical treatment Dilation and curettage (D&C) Emergency D&C
TOTAL PATIENTS N = 72
BEFORE TRAINING N = 45
AFTER TRAINING N = 27
pvalue
31 [28–36] 66 (91.7 %) 10 (13.9 %) 6 (8.3 %) 2 [1–4] 1 [0–1] 1 [0–1] 26 (36.1 %) 9 (12.5 %)
31 [28–35] 42 (93.3 %) 4 (8.9 %) 4 (8.9 %) 2 [1–4] 1 [0–1] 1 [0–1] 15 (33.3 %) 8 (17.8 %)
33 [27–38] 24 (88.9 %) 6 (22.2 %) 2 (7.4 %) 2 [1–3.5] 1 [0–1] 1 [0–1] 11 (40.7 %) 1 (3.7 %)
0.46 0.67 0.16 1 0.82 0.73 0.83 0.61 0.14
8 [7–10] 54 (75 %) 7 (9.7 %) 11 (15.3 %)
8 [7–10] 73.3 % 4 (8.9 %) 8 (17.8 %)
8 [6.5–10] 77.8 % 3 (11.1 %) 3 (11.1 %)
0.51 0.78
32 (44.4 %) 21 (29.2 %) 16 (22.2 %) 3 (4.2 %)
21 (46.7 %) 11 (24.5 %) 11 (24.5 %) 2 (4.3 %)
11 (40.7 %) 10 (37 %) 5 (18.6 %) 1 (3.7 %)
0.76
Table 2 Perinatal grief scale before and after simulation training. PERINATAL GRIEF SCALE
Patient total n = 72
Before training n = 45
After training n = 27
P-value
Active grief Difficulty coping Despair Total
21.7 8.2 15.8 6.6 16.3 6.4 51.5 5.0
23.5 7.1 16.4 7.1 17.2 6.9 57.3 5.6
18.8 6.7 15.3 5.4 14.8 5.5 39.4 4.9
0.02 0.11 0.06 0.03
Table 3 Patients’ impressions before and after simulation training. TOTAL PATIENTS N = 72 Attitude of the physician Consideration Empathy Availability Communication Blunt Empathetic Global information Incomprehensible Insufficient Awkward Too technical The information concerning the following was understandable and complete: Cause of the pregnancy loss Short-term care Middle-term care Psychological consultation offered Need for additional information
BEFORE TRAINING N = 45
AFTER TRAINING N = 27
p-value
43 (59.7 %) 49 (68.1 %) 29 (40.3 %)
22 (48.9 %) 28 (62.2 %) 13 (28.9 %)
20 (74.1 %) 21 (77.8 %) 16 (59.3 %)
0.04 0.17 0.01
29 (40.3 %) 32 (44.4 %)
19 (42.2 %) 17 (37.8 %)
10 (37.0 %) 15 (55.6 %)
0.60 0.14
27 (37.5 %) 25 (34.7 %) 24 (33.3 %) 15 (20.8 %)
21 (46.7 %) 18 (40.0 %) 17 (37.8 %) 9 (20.0 %)
6 7 7 6
0.04 0.22 0.30 0.82
36 (52.3 %) 48 (66.7 %) 42 (58.3 %) 11 (15.3 %) 42 (58.3 %)
21 (46.6 %) 25 (55.6 %) 25 (55.5 %) 4 (8.8 %) 33 (73.3 %)
15 (56.6 %) 23 (85.2 %) 17 (63.0 %) 7 (26.0 %) 9 (33.3 %)
evaluation [19], and our study is among the first to show that level of impact of simulation training, thus presenting a new solid argument in its favor. Indeed, most studies assessing simulation training have assessed the reaction (level 1), the learning (level 2), or the behavior (level 3) of the participants Our study has several limitations. Indeed, the single center, uncontrolled ‘before-after’ design could lead to a several biases, and
(22.2 (25.9 (25.9 (22.2
%) %) %) %)
0.46 0.01 0.54 0.09 0.01
the relatively small sample size is associated with a lower statistical power. However, we included a homogenous population, comparable in all characteristics between the two groups. Moreover, the beforeafter design is the standard design for studies performed to demonstrate an improvement in morbidity and mortality following simulation training in obstetrics and gynecology [20]. The main strength of our study is the use of the validated perinatal grief scale,
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which was based on a meta-analysis published in 2011 which aimed to identify the best scale of psychological reactions to a miscarriage [18]. The study found that a non-appropriate scale would lead to over diagnoses of depression, and recommended the use of the Potvin perinatal grief scale, especially for first trimester losses [18]. Several studies in the literature have reported that most patients look for an active and considerate support from their treating physicians [12,14,15], and many demand a consultation with a psychologist following the early pregnancy loss [21,22]. However, a recent Cochrane review of randomized controlled trials found there was not sufficient evidence to demonstrate that a systematic psychological counselling is effective following a miscarriage, as no improvement in the psychological well-being, including anxiety, grief, depression, avoidance and self-blame, was noted [23]. We believe it is appropriate to inform the couples about the availability and the benefits of a psychological consultation following the diagnosis, especially in cases with a high risk of anxiety or depression [12]. Whether they decide to go for it or not will be entirely their own decision. However, and despite our policy, few patients were offered a psychology consultation, and even though the simulation training improved the rate, it remained low and in need of further improvement. On the other hand, It is essential for patients to be informed about the cause of the miscarriage and the consequences it might have on their future fertility [12,22]. Indeed, studies have shown that the fear of a future recurrence and/or future infertility cause a considerable amount of anxiety, most notably in the short term, in couples recently diagnosed with an EPL [24]. Moreover, these couples tend to consider themselves isolated cases, dealing with a rare condition. Indeed, a recent national survey on public perceptions of miscarriage by Bardos et al. showed that half of participants thought that early pregnancy loss occurs in less than 5 % of couples [25]. This is why it is important to increase awareness among physicians and residents about the sensitive condition of the couples, and the fear they face following an EPL. The physician announcing the diagnosis should be aware of all that and act accordingly, by providing complete and adequate information, in an empathic and considerate way. Our study shows that simulation training improves these aspects of the disclosure. Simulation training is often used in the field of oncology for the communication of cancer diagnosis, a considerably stressful situation for physicians and residents, where the choice of words is primordial, since cancer is a life-threatening diagnosis. Studies have shown that it significantly improves the students’ performance [26]. Baer et al. went even further, by asking cancer survivors to play the role of patients in simulation training scenarios about the communication of cancer diagnosis [27]. The study showed the students were very satisfied with the module, and gained significant confidence following training (Kirpatrick level 1). Role-playing with cancer survivor volunteers added a certain emotional depth to the simulation exercise, and was deemed an effective method of teaching medical students how to disclose bad news [27]. Unfortunately, the psychological morbidity of the survivors was not assessed. Overall, in the field of obstetrics and gynecology, the communication of bad news is relatively frequent, whether it concerns a failed in vitro fertilization cycle, an early or late pregnancy loss, a fetal malformation on ultrasound scan . . . The attitude of the physician when communicating the diagnosis, and the quantity and quality of the information presented are essential for the patient’s personal experience, and can have a significant impact on recovery and future health. Our study has shown that simulation training improves these aspects in patients with early pregnancy loss, and we believe simulation training should be used for disclosure of bad news in to other fields of obstetrics and gynecology, such as reproductive endocrinology and infertility, high risk pregnancies, and gynecologic oncology.
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Conclusion In conclusion, our study has shown that simulation training of residents for the disclosure of the diagnosis of early pregnancy loss significantly improves the couples’ personal experience and decreases the psychological morbidity associated with the diagnosis. Simulation training offers several advantages to physicians and residents, and should be made available in all residency programs. Further studies are needed to improve its efficiency and confirm its value in other scenarios and fields. Ethics committee approval The local ethics committee of University Hospital of Angers approved the study Author’s roles GL: study design, study execution, data analysis and critical discussion. MG: study execution, data analysis, manuscript drafting and critical discussion. CV: manuscript drafting and critical discussion. PEB: critical discussion and revision of the paper. RC: critical discussion and revision of the paper. PD: critical discussion and revision of the paper. All authors approved the final version being submitted. Funding None. Declaration of Competing Interest None declared. References [1] Ectopic pregnancy and miscarriage: diagnosis and initial management | Guidance and guidelines | NICE. https://www.nice.org.uk/guidance/cg154/ chapter/Terms-used-in-this-guideline. [2] Huchon C, Deffieux X, Beucher G, Capmas P, Carcopino X, CostedoatChalumeau N, et al. Pregnancy loss: french clinical practice guidelines. Eur J Obstet Gynecol Reprod Biol 2016;201(June):18–26. [3] Hemminki E, Forssas E. Epidemiology of miscarriage and its relation to other reproductive events in Finland. Am J Obstet Gynecol 1999;181(2):396–401. [4] Lemery D, Legendre G, Huchon C, Perrier I, Deffieux X. [Guidelines for clinical practice: « Pregnancy losses ». Introduction and legislation]. J Gynecol Obstet Biol Reprod (Paris) 2014;43(10):748–52. [5] Lok IH, Neugebauer R. Psychological morbidity following miscarriage. Best Pract Res Clin Obstet Gynaecol 2007;21(2):229–47. [6] Janssen HJ, Cuisinier MC, Hoogduin KA, de Graauw KP. Controlled prospective study on the mental health of women following pregnancy loss. Am J Psychiatry 1996;153(February (2)):226–30. [7] Prettyman RJ, Cordle CJ, Cook GD. A three-month follow-up of psychological morbidity after early miscarriage. Br J Med Psychol 1993;66(Pt 4):363–72. [8] Brier N. Anxiety after miscarriage: a review of the empirical literature and implications for clinical practice. Birth Berkeley Calif 2004;31(June (2)):138–42. [9] Neugebauer R, Kline J, O’Connor P, Shrout P, Johnson J, Skodol A, et al. Depressive symptoms in women in the six months after miscarriage. Am J Obstet Gynecol 1992;166(January (1 Pt 1)):104–9. [10] Friedman T, Gath D. The psychiatric consequences of spontaneous abortion. Br J Psychiatry J Ment Sci 1989;155(December):810–3. [11] Garel M, Blondel B, Lelong N, Kaminski M. Depressive disorders after a spontaneous abortion. Am J Obstet Gynecol 1993;168(March(3 Pt 1)):1005–6. [12] Legendre G, Gicquel M, Lejeune V, Iraola E, Deffieux X, Séjourné N, et al. [Psychology and pregnancy loss.]. J Gynecol Obstet Biol Reprod (Paris) 2014;43 (November 10):908–17. [13] Arck PC, Rücke M, Rose M, Szekeres-Bartho J, Douglas AJ, Pritsch M, et al. Early risk factors for miscarriage: a prospective cohort study in pregnant women. Reprod Biomed Online 2008;17(July (1)):101–13. [14] Cuisinier MC, Kuijpers JC, Hoogduin CA, de Graauw CP, Janssen HJ. Miscarriage and stillbirth: time since the loss, grief intensity and satisfaction with care. Eur J Obstet Gynecol Reprod Biol 1993;52(December (3)):163–8. [15] Evans L, Lloyd D, Considine R, Hancock L. Contrasting views of staff and patients regarding psychosocial care for Australian women who miscarry: a hospital based study. Aust N Z J Obstet Gynaecol 2002;42(May (2)):155–60.
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Journal of Gynecology Obstetrics and Human Reproduction xxx (2019) xxx–xxx
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Original Article
Positive impact of simulation training of residents on the patients’ psychological experience following pregnancy loss C. Verhaeghea , M. Gicquela , P.E. Boueta , R. Corroennea , P. Descampsa , G. Legendrea,b,* a b
Service de Gynécologie-Obstétrique, CHU Angers, 49933 Angers Cedex, France CESP-INSERM, U1018, Equipe 7, Genre, Santé Sexuelle et Reproductive, Université Paris Sud, 94276 Villejuif, France
A R T I C L E I N F O
A B S T R A C T
Article history: Received 20 July 2019 Received in revised form 2 November 2019 Accepted 4 November 2019 Available online xxx
Objective: Our study aimed to assess the impact of a simulation training program for residents for the disclosure of diagnosis on the psychological experience of couples following a first trimester pregnancy loss (PL). Methods: We performed an uncontrolled prospective single center, before-after study, at the gynecological emergency department of Angers University Hospital in France, between May 2014 and April 2015. We included all patients who had a confirmed diagnosis of first trimester PL. A selfadministering questionnaire (SAQ) that included the short version of the perinatal grief scale (PGS) and questions about the couples’ personal experience was sent by mail 8 weeks after the diagnosis. Patients were included before and after simulation training of the residents on the communication of the diagnosis of PL, and scores were compared between the two groups (before and after training). Results: Overall 72 patients fulfilled the inclusion criteria and responded to the SAQ, 45 before and 27 after simulation training. Overall, simulation training significantly lowered the overall PGS (39.4 4.9 vs 57.3 5.6, p = 0.03), significantly improved the attitude of the resident when announcing the diagnosis (more considerate (74.1 % vs 48.9 %, p = 0.04) and available (59.3 % vs 28.9 %, p = 0.01)), and significantly improved the quality of the information given (less incomprehensible (22.2 % vs 46.7 %, p = 0.04). Finally, significantly fewer patients reported needing an additional consultation for further information following training (33.3 % vs 73.3 %, p = 0.01). Conclusion: Simulation training of residents for the disclosure of early pregnancy loss significantly improves the couples’ personal experience and decreases the psychological morbidity associated with the communication. © 2019 Published by Elsevier Masson SAS.
Keywords: Simulation Training Pregnancy loss Miscarriage Perinatal grief scale
Introduction First trimester pregnancy loss (PL), also known as early pregnancy loss (EPL), spontaneous abortion, or miscarriage, refers to the loss of a clinical pregnancy before 14 weeks gestational age (GA) [1,2]. Its incidence is estimated between 10 and 15 %, and it increases with maternal age [3,4]. EPL can have important psychological consequences for the woman, her partner, and the couple [5]. Indeed, following EPL, women have reported feelings of grief, guilt, hopelessness, and anxiety (20–40 %) [6–8], while depression has been reported to affect up to 50 % of patients [9–11]. Moreover, studies have reported a temporary increase in anxiety, depression and post-traumatic stress levels in women during the
* Corresponding author at: Service de Gynécologie-Obstétrique, Centre Hospitalier Universitaire d’Angers, 4 rue Larrey, 49033 Angers Cedex 01, France. E-mail address: [email protected] (G. Legendre).
first trimester of the ensuing pregnancy following an EPL [12]. Fortunately, most of these feelings are transient, and the majority of patients resume their normal lives within one year [12]. However, some of these emotions, if not dealt with correctly, could impact the course of future pregnancies, with some studies reporting a consequently increased risk of recurrence [11–13]. The disclosure of a diagnosis of pregnancy loss is an essential aspect of the initial management, and several studies have confirmed the impact of the physician’s attitude when announcing the diagnosis on the couple’s well-being [12,14,15]. Unfortunately, not all physicians are aware of the importance of their comportment – which can be affected by several factors, some dependent and others completely independent of the physician and the consequences it can have on the couple’s personal experience. In France, most diagnoses of EPL are made in the gynecologic emergency departments, and are handled by residents in training, which can lead to less than adequate disclosures and thus leave the couples with a bad experience [16]. Physicians and
http://dx.doi.org/10.1016/j.jogoh.2019.101650 2468-7847/© 2019 Published by Elsevier Masson SAS.
Please cite this article in press as: C. Verhaeghe, et al., Positive impact of simulation training of residents on the patients’ psychological experience following pregnancy loss, J Gynecol Obstet Hum Reprod (2019), https://doi.org/10.1016/j.jogoh.2019.101650
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residents should take into consideration the sensitivity of the situation, and take their time to adequately address and give the proper information to the patients and their partners. Since Obstetrics and Gynecology residents are frequently exposed to these situations, it is important they get the appropriate training in order to adequately handle and counsel the couples. Nowadays, simulation training plays an important role in residents’ cursus and training, and is currently being used to help residents communicate difficult news to patients and family members [17]. However, to this date, it has not been used in the setting of disclosure of the diagnosis of early pregnancy loss. Therefore, we undertook a prospective study to assess the impact of a simulation based training program for residents on the couples’ personal experience following confirmation of an EPL in the emergency department. Materials and methods Patients We undertook an uncontrolled prospective single center, before-after study, at the gynecological emergency department of Angers University Hospital in France, between May 2014 and April 2015. All patients presenting to the emergency department with the suspicion of an EPL – defined as PL before 14 weeks gestational age (GA) – were candidates for inclusion. They were identified using the emergency departments admission logs. The study was approved by the Angers University Hospital ethics committee. The exclusion criteria were: Pregnancies achieved with Assisted Reproductive Technologies (ART), since this is a different patient population with different risk factors. Unintended and unwanted pregnancies (achieved despite contraception, or requesting abortion). Patients with a third consecutive first trimester pregnancy loss. Patients with a positive obstetrical history (intra uterine fetal demise, recurrent late miscarriages . . . ). Patients undergoing psychological or psychiatric evaluation or treatment, or using psychotropic medications. Non-French speaking patients. Minor patients (<18 years). Cases where the disclosure of the pregnancy loss was made by the attending physician or the patient’s gynecologist. Cases where the communication was made by a resident who did not attend the training courses.
Intervention All patients were handed an information letter and signed an informed consent before being included in the study. A selfadministering questionnaire (SAQ) was sent by mail 8 weeks after the diagnosis of EPL in the emergency department. The SAQ included two sections: 1) Section one is the short version of the perinatal grief scale (PGS), originally developed by Potvin, Lasker and Toedter (1989), and translated to French (the French version was validated in 2000) [16]. It includes 33 questions, each scored from 1 to 5, distributed into three subscales. The first subscale, active grief, emphasizes the sadness and loss relative to the child. The second, difficulty coping, reflects the difficulty coping with routine activities and other activities, while the third, despair, reflects the lack of hope for a better future, associated with a feeling of worthlessness and guilt. A score is considered high
when greater than the mean added to its standard deviation. In our study, a score was considered high when greater than 42 for PGS-active grief, 30 for PGS-difficulty coping, and 27 for PGSdespair. 2) Section two included binary questions that covered several aspects. First of all, the couple’s medical history, in order to identify a possible exclusion criterion that was not listed in the patient’s medical records; Other questions, developed with the psychiatrists at our hospital, covered the attitude of the resident who examined the patient and confirmed the diagnosis to the couple, as well as the patients’ personal experience. There were also general questions about the cause of PL, the treatment administered, the short- and long-term follow-up, and whether a consultation with a psychologist was proposed following the confirmation of diagnosis. Finally, patients were asked whether all the relevant information was discussed and the important questions asked and answered, and whether another consultation was required later on to obtain additional information or to answer unresolved questions. The SAQ were sent before and after simulation training of the residents in charge of the emergency units. Training centered only around the communication of miscarriage, and was led by senior obstetricians/gynecologists from the Obstetrics and Gynecology department of Angers University Hospital, all instructors at the Angers simulation center. Each session was 3 h long, and included 3 pregnancy loss or threatened miscarriage disclosure scenarios. All simulation scenarios included the three conventional components: initial briefing, followed by clinical simulation and debriefing. The roles of the patients and their spouses were played by trained actors who regularly work in our simulation center, and who already had experience in the subject of communication in critical medical situations (newly diagnosed cancer, decision not to resuscitate . . . ). The simulation sessions took place “in situ” in the emergency department, where the real-life consultation occurs, and the participants watched via a live video transmission. The clinical scenarios resolved around patients consulting in the emergency department for metrorrhagia or pelvic pain during the first trimester, with the resident having to diagnose and disclose a threatened miscarriage or a pregnancy loss. There were several clinical contexts: recurrent pregnancy loss or first pregnancy, patients crying or completely mute, spontaneous pregnancy or via ART, medical or surgical treatment needed or no treatment required at all. The simulation sessions took place during two consecutive semesters. Two sessions of training were performed: one for the residents who were presents from May 2014 to October 2014 and the other one for the residents who were presents from November 2014 to April 2015. The training session was performed at the middle of each semester. During the first three months the residents performed the consultations without a specific training, during the last three months the same residents performed pregnancy loss announcement after training. At all six residents (3 for each semester) were involved. Statistical analysis The data collected from the SAQ and the medical records were anonymized. Patients who did not answer the survey were not sent any reminders or follow-ups, considering the sensitivity of the subject and the choice of some couples not to discuss the issue. Statistical analysis was performed using Stata 11.0 (Stata Corp., College Station. TX). Mean values and standard deviations (SD) were calculated for continuous variables and percentages for the categorical variables. Continuous variables were compared with Student’s t test, and categorical variables were compared with chisquare and Fisher’s exact test. A p value <0.05 was considered statistically significant.
Please cite this article in press as: C. Verhaeghe, et al., Positive impact of simulation training of residents on the patients’ psychological experience following pregnancy loss, J Gynecol Obstet Hum Reprod (2019), https://doi.org/10.1016/j.jogoh.2019.101650
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Results Overall, there were 6328 consultations recorded in the gynecological emergency department during the study period, out of which 1637 (25.5 %) were patients presenting in the first trimester with pelvic pain or metrorrhagia. There were 366 (22.4 %) confirmed diagnoses of pregnancy loss. 159 did not meet the inclusion criteria and were excluded before mailing the survey. 207 questionnaires were therefore sent and 115 patients responded (55.5 %). 43 patients were later excluded, and we ended up including 72 patients. 45 consultations occurred before the simulation training and 27 after. The inclusion and exclusion details are shown in the flowchart (Fig. 1). The characteristics of the patients are shown in Table 1. There were no significant differences in the general characteristics between patients included before or after the residents’ training. The results of the active grief scale survey before and after simulation training are shown in Table 2. Overall, the mean total score was 51.5 5.0, and was 21.7 8.2 for active grief, 15.8 6.6 for difficulty coping, and 16.3 6.4 for despair. Following simulation training, the overall score was significantly improved (39.4 4.9 vs 57.3 5.6, p = 0.03). Looking into the subscales, only the active grief scale was significantly reduced (18.8 6.7 versus 23.5 7.1, p = 0.03), whereas difficulty coping and despair were lower but statistically comparable (Table 2 The impact of simulation training on the patients’ impression and personal experience following the diagnosis is summarized in Table 3. Training significantly improved the attitude of the physician, with more patients reporting the physician was considerate (74.1 % vs 48.9 %, p = 0.04) and available (59.3 % vs 28.9 %, p = 0.01). However, there was no difference in the rate of patients who reported the communication as blunt or empathetic. Concerning the global information received, significantly fewer patients reported the information as incomprehensible following
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training (22.2 % vs 46.7 %, p = 0.04), but there was no difference in the rate of patients who found the information insufficient, awkward, or too technical. On the other hand, regarding the quality of the information given on the PL, significantly more patients reported that the information about short term care was understandable and complete following training (85.2 % vs 55.6 %, p = 0.01), but there was no significant difference for the cause of PL and the long-term care. Overall, a consultation with a psychologist was offered for a relatively few number of patients (15.3 %), and despite an increase following training, the difference did not reach statistical significance (8.8 % vs 26 %, p = 0.09). Finally, significantly fewer patients reported needing an additional consultation for further information following training (33.3 % vs 73.3 %, p = 0.01). Discussion To the best of our knowledge, our study is the first to assess the impact of simulation training of residents on the communication of the diagnosis of a first trimester pregnancy loss. Overall, we have found a significant improvement in the couples’ personal experience and a significant decrease in the psychological morbidity associated with the disclosure following training. Indeed, the attitude of the physician announcing the pregnancy loss was significantly improved, and the global perinatal grief score was significantly lower after training. Moreover, the information provided was more complete and easier to understand, with fewer patients requiring an additional consultation to address uncovered issues. Overall, we showed an objective improvement in the patients’ psychological morbidity following simulation training of the residents announcing the diagnosis, thus demonstrating a direct benefit of simulation training for patients. This direct impact of training is graded as level 4 in the Kirkpatrick model for training
Fig. 1. Flow chart.
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Table 1 Characteristics of the patients.
HISTORY Median age Work Smokers Alcohol use Gravidity Parity Number of children Nulliparous patients History of abortion CHARACTERISTICS AT THE TIME OF CONFIRMATION OF PREGNANCY LOSS Median gestational age (weeks) Reasons for consultation: Metrorrhagia Pelvic pain Referred following an ultrasound Expulsion mode Spontaneous Medical treatment Dilation and curettage (D&C) Emergency D&C
TOTAL PATIENTS N = 72
BEFORE TRAINING N = 45
AFTER TRAINING N = 27
pvalue
31 [28–36] 66 (91.7 %) 10 (13.9 %) 6 (8.3 %) 2 [1–4] 1 [0–1] 1 [0–1] 26 (36.1 %) 9 (12.5 %)
31 [28–35] 42 (93.3 %) 4 (8.9 %) 4 (8.9 %) 2 [1–4] 1 [0–1] 1 [0–1] 15 (33.3 %) 8 (17.8 %)
33 [27–38] 24 (88.9 %) 6 (22.2 %) 2 (7.4 %) 2 [1–3.5] 1 [0–1] 1 [0–1] 11 (40.7 %) 1 (3.7 %)
0.46 0.67 0.16 1 0.82 0.73 0.83 0.61 0.14
8 [7–10] 54 (75 %) 7 (9.7 %) 11 (15.3 %)
8 [7–10] 73.3 % 4 (8.9 %) 8 (17.8 %)
8 [6.5–10] 77.8 % 3 (11.1 %) 3 (11.1 %)
0.51 0.78
32 (44.4 %) 21 (29.2 %) 16 (22.2 %) 3 (4.2 %)
21 (46.7 %) 11 (24.5 %) 11 (24.5 %) 2 (4.3 %)
11 (40.7 %) 10 (37 %) 5 (18.6 %) 1 (3.7 %)
0.76
Table 2 Perinatal grief scale before and after simulation training. PERINATAL GRIEF SCALE
Patient total n = 72
Before training n = 45
After training n = 27
P-value
Active grief Difficulty coping Despair Total
21.7 8.2 15.8 6.6 16.3 6.4 51.5 5.0
23.5 7.1 16.4 7.1 17.2 6.9 57.3 5.6
18.8 6.7 15.3 5.4 14.8 5.5 39.4 4.9
0.02 0.11 0.06 0.03
Table 3 Patients’ impressions before and after simulation training. TOTAL PATIENTS N = 72 Attitude of the physician Consideration Empathy Availability Communication Blunt Empathetic Global information Incomprehensible Insufficient Awkward Too technical The information concerning the following was understandable and complete: Cause of the pregnancy loss Short-term care Middle-term care Psychological consultation offered Need for additional information
BEFORE TRAINING N = 45
AFTER TRAINING N = 27
p-value
43 (59.7 %) 49 (68.1 %) 29 (40.3 %)
22 (48.9 %) 28 (62.2 %) 13 (28.9 %)
20 (74.1 %) 21 (77.8 %) 16 (59.3 %)
0.04 0.17 0.01
29 (40.3 %) 32 (44.4 %)
19 (42.2 %) 17 (37.8 %)
10 (37.0 %) 15 (55.6 %)
0.60 0.14
27 (37.5 %) 25 (34.7 %) 24 (33.3 %) 15 (20.8 %)
21 (46.7 %) 18 (40.0 %) 17 (37.8 %) 9 (20.0 %)
6 7 7 6
0.04 0.22 0.30 0.82
36 (52.3 %) 48 (66.7 %) 42 (58.3 %) 11 (15.3 %) 42 (58.3 %)
21 (46.6 %) 25 (55.6 %) 25 (55.5 %) 4 (8.8 %) 33 (73.3 %)
15 (56.6 %) 23 (85.2 %) 17 (63.0 %) 7 (26.0 %) 9 (33.3 %)
evaluation [19], and our study is among the first to show that level of impact of simulation training, thus presenting a new solid argument in its favor. Indeed, most studies assessing simulation training have assessed the reaction (level 1), the learning (level 2), or the behavior (level 3) of the participants Our study has several limitations. Indeed, the single center, uncontrolled ‘before-after’ design could lead to a several biases, and
(22.2 (25.9 (25.9 (22.2
%) %) %) %)
0.46 0.01 0.54 0.09 0.01
the relatively small sample size is associated with a lower statistical power. However, we included a homogenous population, comparable in all characteristics between the two groups. Moreover, the beforeafter design is the standard design for studies performed to demonstrate an improvement in morbidity and mortality following simulation training in obstetrics and gynecology [20]. The main strength of our study is the use of the validated perinatal grief scale,
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which was based on a meta-analysis published in 2011 which aimed to identify the best scale of psychological reactions to a miscarriage [18]. The study found that a non-appropriate scale would lead to over diagnoses of depression, and recommended the use of the Potvin perinatal grief scale, especially for first trimester losses [18]. Several studies in the literature have reported that most patients look for an active and considerate support from their treating physicians [12,14,15], and many demand a consultation with a psychologist following the early pregnancy loss [21,22]. However, a recent Cochrane review of randomized controlled trials found there was not sufficient evidence to demonstrate that a systematic psychological counselling is effective following a miscarriage, as no improvement in the psychological well-being, including anxiety, grief, depression, avoidance and self-blame, was noted [23]. We believe it is appropriate to inform the couples about the availability and the benefits of a psychological consultation following the diagnosis, especially in cases with a high risk of anxiety or depression [12]. Whether they decide to go for it or not will be entirely their own decision. However, and despite our policy, few patients were offered a psychology consultation, and even though the simulation training improved the rate, it remained low and in need of further improvement. On the other hand, It is essential for patients to be informed about the cause of the miscarriage and the consequences it might have on their future fertility [12,22]. Indeed, studies have shown that the fear of a future recurrence and/or future infertility cause a considerable amount of anxiety, most notably in the short term, in couples recently diagnosed with an EPL [24]. Moreover, these couples tend to consider themselves isolated cases, dealing with a rare condition. Indeed, a recent national survey on public perceptions of miscarriage by Bardos et al. showed that half of participants thought that early pregnancy loss occurs in less than 5 % of couples [25]. This is why it is important to increase awareness among physicians and residents about the sensitive condition of the couples, and the fear they face following an EPL. The physician announcing the diagnosis should be aware of all that and act accordingly, by providing complete and adequate information, in an empathic and considerate way. Our study shows that simulation training improves these aspects of the disclosure. Simulation training is often used in the field of oncology for the communication of cancer diagnosis, a considerably stressful situation for physicians and residents, where the choice of words is primordial, since cancer is a life-threatening diagnosis. Studies have shown that it significantly improves the students’ performance [26]. Baer et al. went even further, by asking cancer survivors to play the role of patients in simulation training scenarios about the communication of cancer diagnosis [27]. The study showed the students were very satisfied with the module, and gained significant confidence following training (Kirpatrick level 1). Role-playing with cancer survivor volunteers added a certain emotional depth to the simulation exercise, and was deemed an effective method of teaching medical students how to disclose bad news [27]. Unfortunately, the psychological morbidity of the survivors was not assessed. Overall, in the field of obstetrics and gynecology, the communication of bad news is relatively frequent, whether it concerns a failed in vitro fertilization cycle, an early or late pregnancy loss, a fetal malformation on ultrasound scan . . . The attitude of the physician when communicating the diagnosis, and the quantity and quality of the information presented are essential for the patient’s personal experience, and can have a significant impact on recovery and future health. Our study has shown that simulation training improves these aspects in patients with early pregnancy loss, and we believe simulation training should be used for disclosure of bad news in to other fields of obstetrics and gynecology, such as reproductive endocrinology and infertility, high risk pregnancies, and gynecologic oncology.
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Conclusion In conclusion, our study has shown that simulation training of residents for the disclosure of the diagnosis of early pregnancy loss significantly improves the couples’ personal experience and decreases the psychological morbidity associated with the diagnosis. Simulation training offers several advantages to physicians and residents, and should be made available in all residency programs. Further studies are needed to improve its efficiency and confirm its value in other scenarios and fields. Ethics committee approval The local ethics committee of University Hospital of Angers approved the study Author’s roles GL: study design, study execution, data analysis and critical discussion. MG: study execution, data analysis, manuscript drafting and critical discussion. CV: manuscript drafting and critical discussion. PEB: critical discussion and revision of the paper. RC: critical discussion and revision of the paper. PD: critical discussion and revision of the paper. All authors approved the final version being submitted. Funding None. Declaration of Competing Interest None declared. References [1] Ectopic pregnancy and miscarriage: diagnosis and initial management | Guidance and guidelines | NICE. https://www.nice.org.uk/guidance/cg154/ chapter/Terms-used-in-this-guideline. [2] Huchon C, Deffieux X, Beucher G, Capmas P, Carcopino X, CostedoatChalumeau N, et al. Pregnancy loss: french clinical practice guidelines. Eur J Obstet Gynecol Reprod Biol 2016;201(June):18–26. [3] Hemminki E, Forssas E. Epidemiology of miscarriage and its relation to other reproductive events in Finland. Am J Obstet Gynecol 1999;181(2):396–401. [4] Lemery D, Legendre G, Huchon C, Perrier I, Deffieux X. [Guidelines for clinical practice: « Pregnancy losses ». Introduction and legislation]. J Gynecol Obstet Biol Reprod (Paris) 2014;43(10):748–52. [5] Lok IH, Neugebauer R. Psychological morbidity following miscarriage. Best Pract Res Clin Obstet Gynaecol 2007;21(2):229–47. [6] Janssen HJ, Cuisinier MC, Hoogduin KA, de Graauw KP. Controlled prospective study on the mental health of women following pregnancy loss. Am J Psychiatry 1996;153(February (2)):226–30. [7] Prettyman RJ, Cordle CJ, Cook GD. A three-month follow-up of psychological morbidity after early miscarriage. Br J Med Psychol 1993;66(Pt 4):363–72. [8] Brier N. Anxiety after miscarriage: a review of the empirical literature and implications for clinical practice. Birth Berkeley Calif 2004;31(June (2)):138–42. [9] Neugebauer R, Kline J, O’Connor P, Shrout P, Johnson J, Skodol A, et al. Depressive symptoms in women in the six months after miscarriage. Am J Obstet Gynecol 1992;166(January (1 Pt 1)):104–9. [10] Friedman T, Gath D. The psychiatric consequences of spontaneous abortion. Br J Psychiatry J Ment Sci 1989;155(December):810–3. [11] Garel M, Blondel B, Lelong N, Kaminski M. Depressive disorders after a spontaneous abortion. Am J Obstet Gynecol 1993;168(March(3 Pt 1)):1005–6. [12] Legendre G, Gicquel M, Lejeune V, Iraola E, Deffieux X, Séjourné N, et al. [Psychology and pregnancy loss.]. J Gynecol Obstet Biol Reprod (Paris) 2014;43 (November 10):908–17. [13] Arck PC, Rücke M, Rose M, Szekeres-Bartho J, Douglas AJ, Pritsch M, et al. Early risk factors for miscarriage: a prospective cohort study in pregnant women. Reprod Biomed Online 2008;17(July (1)):101–13. [14] Cuisinier MC, Kuijpers JC, Hoogduin CA, de Graauw CP, Janssen HJ. Miscarriage and stillbirth: time since the loss, grief intensity and satisfaction with care. Eur J Obstet Gynecol Reprod Biol 1993;52(December (3)):163–8. [15] Evans L, Lloyd D, Considine R, Hancock L. Contrasting views of staff and patients regarding psychosocial care for Australian women who miscarry: a hospital based study. Aust N Z J Obstet Gynaecol 2002;42(May (2)):155–60.
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