Abstract
Background:
Endometriosis is a debilitating chronic inflammatory disease. The current SARS-COV2 pandemic has had an impact on the management of these patients. Tele-health care has been a relevant tool. The aim of this study was to analyze the impact of the SARS-COV2 pandemic on the perceived clinical health status and the type of care received in patients with endometriosis.
Materials and Methods:
We evaluated 945 premenopausal women treated at the Hospital Clinic of Barcelona between October 1 and December 31, 2020. Five hundred forty-nine women had endometriosis, and 396 had other benign gynecological diseases. An online health survey was sent to these patients. Clinicopathological features data were recorded.
Results:
Compared to patients with other benign gynecological diseases, a higher proportion of patients with endometriosis reported worsening of their symptoms (148/549, 27% vs. 85/396, 21.5%) and concern about their disease (515/549, 93.8% vs. 342/396, 86.4%), and more frequently received tele-health care (73.8% vs. 54.0%) during the pandemic. Patients with endometriosis and “significant” pelvic pain reported more concern and worsening than patients without “significant” pelvic pain, and evaluated the assistance received poorly. Multivariate analysis showed pelvic pain, limitation in usual activity, and sadness as risk factors of perception of disease worsening. Awaiting surgery and the feeling of sadness were risk factors of concern.
Conclusions:
Patients with endometriosis, and especially patients with “significant” pelvic pain, reported greater concern and the perception of worsening during the SARS-COV2 pandemic. Tele-health is a useful tool in patients with endometriosis, and face-to-face visit should be considered in those reporting “significant” pelvic pain. Clinical Trial Registration Number: HCB 1202011497.
Introduction
The current SARS-COV2 pandemic has had an impact on the management and follow-up of patients with chronic diseases. Endometriosis affects 10%–15% of women of reproductive age. 1 Dysmenorrhea, dyspareunia, chronic pelvic pain, ovulation pain, cyclical or perimenstrual symptoms, abnormal bleeding, infertility, and chronic fatigue are frequently presented in women with endometriosis, 2 being a debilitating chronic inflammatory disease with impact on social, occupational, and psychological functioning, 3 requiring follow-up and health care as in other chronic diseases. 4
While medical therapy is the first-line treatment for women with endometriosis, 1 many patients still require surgery. Hormonal treatments (oral contraceptives, gonadotropin-releasing hormone, and hormonal intrauterine devices, among others), anti-inflammatories and analgesics, or others symptomatic treatments (tranexamic acid, iron therapy in cases of coexistent abnormal uterine bleeding) are the therapeutic strategies for patients with endometriosis. 1,2,5 These patients require follow-up, monitoring, and optimization of their treatments. In addition, they may sometimes need emergency care for important anemia, uncontrollable abnormal uterine bleeding, or intestinal occlusion requiring surgery and/or hospitalization. 2
The SARS-COV2 pandemic has affected the management and clinical impact of patients with endometriosis. To reduce the risk of SARS-COV2 infection in patients, some strategies have been applied in different health institutions, including the limitation of surgical procedures and patient contact with health care workers and health care centers. 6 Optimization of health care and adjustment to these limitations has been challenging, and tele-health visits by phone contact, email, or videoconferences replaced face-to-face visits during the SARS-COV2 pandemic. 7,8
In cases where physical assistance was necessary, security measures were strictly applied. Many hospitals have implemented universal testing for SARS-COV2 in the case of surgical interventions, deliveries, and hospitalizations. 9 Several studies have analyzed the optimization of care in patients with gynecological cancers during the SARS-COV2 pandemic 6,10 and have reported the significant impact SARS-COV2 has had on gynecology services. 11 However, the impact of the SARS-COV2 pandemic on patients with endometriosis has not been described.
The aim of this study was to analyze and describe the impact of the SARS-COV2 pandemic on the clinical perception and concern of patients with endometriosis treated in a tertiary hospital, and determine the perception of current modifications of care based on tele-health in our patients and correlate the findings with the clinical features.
Materials and Methods
Study design
This prospective online survey study included premenopausal women diagnosed with endometriosis, undergoing medical treatment at the Gynecological Service of the Hospital Clinic (Barcelona, Spain) during the current SARS-COV2 pandemic. Patients provided consent to be contacted by mail. The control group included premenopausal women with other benign gynecological diseases (with evolution for more than 6 months), excluding endometriosis. Exclusion criteria were as follows: patients younger than 18 years (are legally considered minors), menopausal women, evolution of the pathology less than 6 months, and the inaccessibility to computing or mail. Patients with and without endometriosis were included with a 1: 1 ratio, between October 1 and December 31, 2020.
The clinicopathological features (age, diagnosis, surgery, gynecological symptomatology, and SARS-COV2 infection) and the follow-up data (pandemic evolution, type of assistance, and tele-health assistance) were recorded by a health survey sent to all patients who accepted contact by mail. A brief adaptation of the symptom and quality-of-life questionnaires 12,13 was completed by the patients. The survey items were the following: abnormal uterine bleeding, abdominal tightness, pelvic pain, urination discomfort, fatigue, sadness, and limitation in usual activity and work. Patients scored each item on a 5-point Likert scale (range 1–5), with 1 corresponding to an asymptomatic state and 5 to the worst clinical situation. 13 Likert-type questions were categorized into five answers: nothing (1), a little/soft (2), something/moderate (3), quite a lot/intense (4), and a lot/unbearable (5).
In addition, we asked patients about their perception of their global clinical situation (worsening, stability, or improvement) and gynecological concern (more, equal, or less concerned) at the time of the survey. To evaluate the modifications of care in our patients during the pandemic, we registered the total ambulatory medical visits necessary in the previous 6 months (face-to-face visits and tele-health), the need for emergency care or hospitalization, and the perception of the quality of care received (enough/correct vs. insufficient/incorrect). Among patients receiving tele-health care, the type of care received during the SARS-COV2 pandemic was qualitatively and quantitatively evaluated (useful/useless and quantitative scale from 0 to 10, respectively).
No additional intervention was performed in the patients. The survey was completely anonymous and without personal identification data. The study was approved by the Ethics Committee of Clinical Research of the Hospital Clinic (registry HCB/2020/1497).
Clinical management during the SARS-COV2 pandemic
To reduce the risk of SARS-COV2 infection, our service established a protocol of assistance and follow-up with reduction of face-to-face visits during the SARS-COV2 pandemic. Gynecologists individually reviewed the records of their scheduled patients, and depending on their clinical condition, each patient was classified to undergo face-to-face assessment or tele-health by phone.
Patients underwent face-to-face visit in cases of abnormal uterine bleeding and abdominal or pelvic pain with non-response or partial response to medical treatment. All patients who underwent surgery received face-to-face visit 1 month after hospital discharge. Patients who required histological studies (endometrial biopsy), microbiological study (sample for culture), gynecological ultrasound, or hysteroscopy required a face-to-face visit. Patients with chronic treatments, patients who required to report the results of performed examinations or analytical controls, received a phone call to monitor their evolution, adjust doses if necessary, and request future examinations.
For face-to-face visits, the security measures included the following: individual access to the health institution, mandatory mask, no delay in visit time, 30-minute interval, and cleaning of the exploration room between patients, and security measures for health care professionals (mandatory mask, personal protection clothing, and gloves, hand hygiene before and after each patient with soap and hydroalcoholic solution). In patients with suspicious symptoms of SARS-COV2, the face-to-face visit was postponed for at least 15 days. For tele-health care, patients received prior notification regarding the day and time at which the gynecologist would call them by phone.
After the evaluation by phone, the gynecologist programmed the next follow-up (face-to-face or tele-health), complementary exploration (ultrasonography, resonance magnetic imaging, mammography, etc.), and the priority according to the clinical condition of each patient. To facilitate contact with the advanced nurse practitioner if needed, an email address and phone number were provided.
Patients with symptomatic pathologies, who were not eligible for ambulatory medical treatment (pelvic pain with no response to oral treatment, severe anemia, heavy bleeding, and intestinal occlusion, among others), were programmed to hospitalization treatment following security measures to avoid SARS-COV2 infection.
Statistical analysis
Data analyses were performed with the SPSS 23.0 statistical package (SPSS, Chicago, IL, USA). Qualitative variables were expressed as absolute numbers and percentages, and quantitative variables as mean and standard deviation (SD). The Chi-square exact test and the Student's t-test were used for comparisons, respectively. For data analysis, patients without but with benign gynecological diseases other than endometriosis (uterine fibroids, adnexal cysts, hormonal disorders, among others) were considered group without endometriosis, whereas cases with any type of endometriosis (deep infiltrating endometriosis, and endometriomas, among others) were considered the endometriosis study group.
Univariate and multivariate analysis (logistic regression) were used to determine risk factors for clinical worsening and greater clinical concern during the SARS-COV2 pandemic in patients with endometriosis. For analysis purposes, Likert-type questions were categorized into two types according to the study aims: nothing (1) and a little/soft (2) were coded as “<3 or nonsignificant” and something/moderate (3), quite a lot/intense (4), and a lot/unbearable (5) were coded as “≥3 or significant.” 13 Thus, patients with “≥3 or significant” pelvic pain were women who answered having moderate, intense, or unbearable pain. The variables clinical worsening and clinical concern were coded as categorical variables (0/1) based on the perception of patients in the survey. Odds ratios and lower and upper levels of 95% confidence intervals were calculated.
The multivariate model included variables showing statistical significance in the univariate models. The level of significance adopted was 0.05.
Results
From October 2020 to December 2020, 1200 patients from the Benign Gynecology Unit (600 with endometriosis and 600 without endometriosis) were invited to participate in the study and were sent the health survey. Finally, 945 patients (78.7%) answered the health survey and were included in the analysis.
The mean age of the patients was 39.6 years (SD 7.1) and 549 (58.1%) women had endometriosis and 396 (41.9%) had other benign gynecological pathologies. Among the latter, 133 (33.6%) had hormonal disorders (36 polycystic ovary syndrome, 15 other hyperandrogenisms, 20 hypothalamic-pituitary syndromes, and 62 dysfunctional bleeding), 130 (32.8%) had uterine fibroids, 38 (9.6%) had adnexal cysts, excluding endometriomas, and the remaining 95 (24.0%) had other pathologies (31 persistent sexually transmitted diseases, 20 recurrent vulvovaginitis, 33 endometrial polyps, 11 chronic pelvic pain due to previous sterilization by ESSURE© devices (7 patients) or migration of intrauterine devices (4 patients), who required contraception planning through salpingectomy and removal of previous contraceptives devices).
Eighty (8.5%) women were infected by SARS-COV2. Four of these (5.0%) women required hospitalization and 59 (73.7%) showed complete recovery at the time of the survey.
There were no clinical differences regarding the mean age between patients with and without endometriosis (39.4 years, SD 6.5 vs. 39.8 years, SD 7.9, respectively, p = 0.40). Patients with endometriosis less frequently waited for surgery than patients without endometriosis (43/549, 7.8% vs. 55/396, 13.9%, respectively, p < 0.01). In patients with endometriosis, 6.9% (38/549) had SARS-COV2 infection during the first semester of the pandemic compared to 9.8% (39/396) of women with other benign gynecological diseases, without statistically significant differences (p = 0.10).
Table 1 shows the perception of clinical status and concern of patients during the SARS-COV2 pandemic, with 19.7% of patients (186/945) reporting being more concerned about their pathologies, and 24.6% of patients (233/945) considered that their disease had worsened. A higher proportion of patients with endometriosis reported worsening of their symptoms (148/549, 27% vs. 85/396, 21.5%, p = 0.04) with worse clinical symptom scores (p < 0.01), except for the abnormal uterine bleeding score (p = 0.36). With regard to the clinical concern of the patients, women with endometriosis more frequently reported the same or greater concern about their gynecological disease than those without endometriosis during the SARS-COV2 pandemic (p < 0.01).
Clinical Status and Concern of Patients With and Without Endometriosis During the SARS-COV2 Pandemic
Values are given as absolute numbers and percentages.
Likert scale adaptation: Range 1–5/Likert-type questions were categorized into two: nothing (1) and a little/soft (2) were coded as “ <3 or nonsignificant” and something/moderate (3), quite a lot/intense (4), and a lot/unbearable (5) were coded as “≥3 or significant.”
AUB, abnormal uterine bleeding; SARS-COV2, severe acute respiratory syndrome coronavirus 2; SD, standard deviation.
In relation to the type of care received, 461 (48.8%) patients required face-to-face care during the pandemic, 619 (65.5%) received tele-health contact by phone, 83 (8.8%) required emergency assistance, and 35 (3.7%) required hospitalization.
Patients with endometriosis more frequently followed tele-health assistance (405/549, 73.8% vs. 214/396, 54.0%, p < 0.01) and required emergency assistance (58/549, 10.6% vs. 25/396, 6.3%, p = 0.02), and patients without endometriosis face-to-face appointments (242/549, 44.1% vs. 219/396, 55.3%, p < 0.01). However, no difference was found between groups in terms of hospitalization (Table 2). In 787 (83.3%) women, the global assessment regarding the care received during the SARS-COV2 pandemic was “enough/correct,” without statistical differences between groups. No difference was found between groups in terms of the evaluation of the received tele-health assistance (Table 2).
Health care in Patients With and Without Endometriosis During the SARS-COV2 Pandemic
Values are given as absolute numbers and percentages or mean and SD.
Patients were able to receive more than one type of care.
Evaluation of the 619 patients who received tele-health care.
Quantitative scale 1–10.
On analyzing patients with endometriosis separately, patients with “significant” pelvic pain (pain score ≥3) more frequently reported worsening of their symptoms, greater concern about their disease, “insufficient/incorrect” quality of care during the SARS-COV 2 pandemic, and ineffectiveness of tele-health, and gave a worse quantitative tele-health evaluation than patients without or with “nonsignificant” pelvic pain (pain score <3) (Table 3). Regarding the type of care received, patients with “significant” pelvic pain more frequently required emergency care and hospitalization, but there was no significant difference in the type of ambulatory care received (face-to-face or tele-health) (Table 3).
Clinical Status and Health Care of Endometriosis Patients With or Without Significant Pain During the SARS-COV2 Pandemic
Values are given as absolute numbers and percentages or mean and SD.
Pain Likert-type questions were categorized into two: nothing (1) and a little/soft (2) were coded as “ < 3 or nonsignificant pain” and something/moderate (3), quite a lot/intense (4), and a lot/unbearable (5) were coded as “≥3 or significant pain.”
Patients were able to receive more than one type of care.
Evaluation of the 405 patients with endometriosis who received tele-health care.
Quantitative scale 1–10.
In the univariate analysis, surgery indication, “significant” clinical symptoms (pelvic pain, abnormal uterine bleeding, abdominal tightness, urination discomfort, fatigue, limitation in usual activity and work, and sadness), emergency care, and hospitalization were associated with the perception of clinical worsening and greater concern about the disease during the SARS-COV2 pandemic (data not shown). However, in the multivariate analysis, only “significant” pelvic pain, limitation in usual activity, sadness, and the need for emergency care remained associated with the perception of clinical worsening of the endometriosis disease (Table 4).
Risk Factors for Perception of Clinical Worsening and Concern About Endometriosis During the SARS-COV2 Pandemic: Multivariate Analysis (Logistic Regression)
Multivariate model includes variables with statistical significance in the univariate analysis.
Waiting for surgery at the time of the survey.
Clinical symptoms: Likert-type questions were categorized into two: nothing (1) and a little/soft (2) were coded as “<3 or nonsignificant” and something/moderate (3), quite a lot/intense (4), and a lot/unbearable (5) were coded as “≥3 or significant.”
CI, confidence interval; OR, odds ratio.
Regarding clinical concern during the SARS-COV2 pandemic, multivariate analysis showed awaiting surgery and “significant” sadness to be associated with greater clinical concern about the endometriosis disease during the SARS-COV2 pandemic (Table 4).
Discussion
The most relevant finding of our study is that women with endometriosis more frequently had the clinical perception of worsening and concern during the SARS-COV2 pandemic than women without endometriosis. We also found statistically significant differences in patients with endometriosis according to pain status, with patients with “significant” pelvic pain more frequently reporting the perception of clinical worsening, more concern, a greater need for emergency care and hospitalization, and giving a worse evaluation of the care received during the SARS-COV2 pandemic. In fact, “significant” pelvic pain was one of the risk factors that remained significant in the multivariate analysis.
Endometriosis is a chronic inflammatory disease, which can frequently cause pain 14 and has a social, occupational, and psychological impact. 3 Indeed, patients with endometriosis had worse symptom scores than those without endometriosis. However, in the multivariate analysis, only “significant” pelvic pain, limitation in usual activity, and sadness remained as risk factors of clinical perception of worsening.
In our study, the proportion of women with endometriosis infected with SARS-COV2 was 6.9%. This result is in keeping with previous series in the province of Barcelona. 15 Another study on the susceptibility to COVID-19 infection in patients with endometriosis did not show an increase in this susceptibility. 16
Other studies in oncogynecological patients showed a higher proportion of women reporting fear of SARS-COV2 infection. Chemotherapy or concern about the cancer progression was a SARS-COV2-related fear of these patients, and older women showed a higher risk of being more afraid. 10 On the other hand, despite having a chronic disease, younger patients with endometriosis did not show SARS-COV2 infection as a risk factor of being more concerned or perceiving clinical worsening. Therefore, awaiting surgery or the perception of sadness remained a significant risk factor of being more concerned about the endometriosis during the current pandemic.
Tele-health assistance is a fundamental tool in emergency or pandemic situations. Nonetheless, despite previous experiences with tele-health, acceptance of this type of care is limited. 7
Patients with endometriosis more frequently received tele-health care than patients with other benign gynecological diseases. However, patients with endometriosis and ‘significant’ pelvic pain more frequently reported the ineffectiveness of tele-health and gave a worse evaluation of this type of care. Studies in patients with other benign gynecological diseases and the need for chronic hormonal treatment showed an adequate follow-up and treatment based on tele-health care during the lockdown. 17 Therefore, despite being a very useful tool, with clear benefits for the follow-up of patients with chronic diseases, and with good acceptation among patients with endometriosis, face-to-face visits should be considered in patients with “significant” pelvic pain, if necessary.
One of the limitations of this study was that the design of the study did not allow determination of the proportion of women with gynecological disease who died because of the SARS-COV2 infection or other causes during the pandemic. Neither could we determine the time since they were infected among women who had SARS-COV2 infection. Another study limitation is the qualitative clinical perception reported by the patients, without the possibility to check this status by the gynecologist. It is also not possible to determine the stage of endometriosis or its involvement due to the study design based on an online survey.
The design of the survey also did not include questions about the infertility, but the reproductive unit team maintained close telephone contact with the patients diagnosed with infertility and the assisted reproduction processes were carried out following strict anti-COVID security measures. Nonetheless, the information obtained regarding the experiences and concerns of our patients regarding this chronic disease during the SARS-COV2 pandemic is important.
Conclusions
In summary, patients with endometriosis, especially those with “significant” pelvic pain, had greater concern and a higher perception of worsening regarding their disease during the SARS-COV2 pandemic. Tele-health is a useful tool in patients with endometriosis, but in women with “significant” pelvic pain, the need for face-to-face visits should be assessed.
Footnotes
Authors' Contributions
I.N., M.A.M.-Z., and F.C. designed the study, selected the patients, interpreted the data, and wrote the article. I.N. sent the health survey, collected the data, and performed the statistical analysis. G.F., M.G., and M.R. were involved in the data collection and answered questions from the participants.
All the authors approved the final article.
Acknowledgment
We thank Donna Pringle for English revision of the article.
Author Disclosure Statement
No competing financial interests exist.
Funding Information
No funding was received for this article.
