Abstract
Background:
Inflammatory bowel disease is a chronic recurrent disease, and the treatment goals of inflammatory bowel disease are mainly based on doctors’ perspective, but there are some differences between the doctor’s perspective and the patient’s perspective. The aim of this study is to understand the treatment goals and the related factors from the patients’ perspective during the coronavirus disease 2019 pandemic.
Methods:
A total of 212 participants were recruited to fill out the questionnaires including clinical characteristics and treatment goals. Eleven treatment goals were measured by a Short-Form 34 questionnaire. Univariate and multivariate regression analyses were used to explore the related factors about these treatment goals.
Results:
A total of 212 inflammatory bowel disease patients were enrolled in this study. The most concerned treatment goal was the improvement of quality of life (mean score was 8.54), while mean score of ulcerative colitis patients and Crohn’s disease patients was 9.10 and 8.45, respectively. We had also found some related factors such as the type of disease, the course of disease, the frequency of hematochezia, and defecation.
Conclusion:
Our survey showed that inflammatory bowel disease patients pay more attention to the improvement of quality of life and few drugs during the coronavirus disease 2019 pandemic. There are some related factors such as the type of disease, the course of disease, the frequency of hematochezia, and defecation. Our results help clinicians understand the patients’ treatment goals, which can contribute to better management of inflammatory bowel disease patients.
Keywords: COVID-19, Crohn’s disease, inflammatory bowel disease, treatment goals, ulcerative colitis
Introduction
Inflammatory bowel disease (IBD) including ulcerative colitis (UC) and Crohn’s disease (CD) is a chronic nonspecific gastrointestinal disease.1 The etiology of IBD is multifactorial, which is closely associated with genetic susceptibility, immunity, environment, and microorganism.2 Inflammatory bowel disease patients are often disturbed by embarrassing gastrointestinal symptoms and systemic symptoms, which give rise to increased rates of frequent hospitalization, surgery, and even death.3 Frequent clinical symptoms such as abdominal pain, diarrhea, and fever can lead to a decline in the quality of life (QoL) of patients with IBD.4
Inflammatory bowel disease treatments were revolutionized with the introduction of anti-tumor necrosis factor (TNF)-α agents (infliximab and adalimumab) in the 1990s. Some new biological agents (vedolizumab and ustekinumab), as well as a small molecule pharmaceutical (tofacitinib), have also been used clinically for IBD patients. This remarkable change has led to significant and long-standing remission in steroid-refractory and steroid-dependent IBD patients, a reduction in surgery rates, and a chance to alter the deleterious disease course of IBD patients.
With the significant increase in IBD treatments, choosing the appropriate therapy for IBD patients becomes more and more challenging. Although many IBD guidelines and consensus give many specific treatment options for the treatment of IBD patients, there are still some aspects that pose great challenges for clinicians to choose treatment options. At present, existing therapeutics differ in mode of application (enteral or parenteral), speed of onset of action, side effects (risk of infectious complications and cancer), and intensity of treatment (combination therapy or monotherapy, frequency of treatment application, and number of tablets).
Coronavirus disease 2019 (COVID-19), which was first reported in Wuhan in December 2019, has already spread all over the world causing a great deal of panic. The major clinical manifestations of patients with COVID-19 are fever, chills, cough, shortness of breath, generalized myalgia, malaise, diarrhea, confusion, dyspnea, and bilateral interstitial pneumonia. The virus that causes this disease was severe acute respiratory syndrome coronavirus 2. The virus enters the cells via the angiotensin-converting enzyme 2 receptor. This receptor is expressed in different tissues, mainly in the intestinal tract. Excessive binding of the virus to the receptor can lead to overactivation of immune cells, which can lead to severe systemic diseases. Some studies showed that gastrointestinal symptoms such as diarrhea and vomiting occurred more frequently in patients with COVID-19. Because patients with IBD are unable to determine whether diarrhea is due to the aggravation of the disease or the infection of COVID-19, it may cause panic to patients with IBD.
During the COVID-19 pandemic (from February 02, 2020 to April 30, 2020), some patients changed their treatment schedules according to our questionnaire.5 These patients do not have access to obtain enough drugs such as infliximab because many hospitals were unable to open and treat non-COVID-19 patients during the COVID-19 pandemic. Some patients use immunosuppressants, steroids, and other drugs which may lead to an increased risk of the COVID-19 infection.6 In fact, the use of immunosuppressants was not associated with an increased risk of COVID-19 in IBD patients.7,8 In order to avoid the COVID-19 infection, some patients have changed their treatment schedules and treatment goals.
Furthermore, enhancing medical therapy and surgical treatment are both valid options in IBD therapy. In addition to IBD treatment selection, patients and physicians sometimes have different priorities regarding treatment goals. For example, physicians often stick to objective parameters, such as mucosal healing and normalization of biomarkers (C-reactive protein (CRP) and fecal calprotectin (FC)). However, IBD patients are more inclined to choose the relief of symptoms as the treatment goals.
While treatment options become more complex and individualized, little is known about IBD patients’ treatment goals. Non-compliance with therapy is common in IBD patients, with rates up to 50%. Non-compliance with therapy leads to an increase in disease activity and frequent relapses, poor QoL, higher disability, morbidity, and mortality. Some studies found that the most important influencing factor about IBD patients’ adherence to medication was patients’ beliefs about medications. However, due to the COVID-19 pandemic, the assessment of the condition of IBD patients has become particularly difficult. Most patients would rather take oral or subcutaneous medication (adalimumab) than go to the hospital for systematic evaluation. These patients are more likely to choose the improvement of symptoms as the treatment goal.
Physicians can improve their physician-patient relationship by understanding the patients’ treatment goals, thereby effectively influencing IBD patients’ adherence to treatment and improving disease prognosis. Therefore, understanding the patients’ treatment goals can contribute to better management of IBD patients during the COVID-19 pandemic. The aims of study were to assess IBD patients-reported treatment goals and the related factors in China during the COVID-19 pandemic by conducting a questionnaire-based survey.
Materials and Methods
Participants and Procedures
This was a cross-sectional observational study. All participants were recruited from patients with IBD who were diagnosed in our hospital from January 2017 to April 2020. The data collection period is from February 01, 2020 to April 30, 2020. The inclusion criteria were: (1) age 18-75 years; (2) a confirmed diagnosis of CD or UC or unclassified IBD, according to the current diagnostic criteria; (3) all participants volunteered to take part in this study; and (4) all participants have ability to understand and complete the questionnaire. Exclusion criteria were: (1) intellectual disability or dementia; (2) severe concomitant diseases; (3) gastrointestinal tumors, severe cardiovascular and cerebrovascular diseases, severe cardiopulmonary function, and liver and kidney dysfunction.
Demographic and Clinical Characteristics
Demographic characteristics were gathered from a self-designed questionnaire, including age, gender, smoking history, place of residence, and type of labor. Clinical characteristics were also extracted, including disease type, year of diagnosis, disease location, history of perianal involvement, abdominal pain, defecation, frequency of hematochezia, disease behavior, disease activity, current medical therapy, and IBD-related surgical history.
All patients received written information. Informed consent was obtained, and ethical approval was granted by Research Ethics Committees.
Questionnaire
All participants were invited to fill out a structured Short-Form 34 questionnaire (Supplementary Table 1). The questions focused on opinions and current practice regarding IBD patients’ self-reported treatment goals. We identified 11 items that represent patients’ self-reported treatment goals (improvement of QoL, few drugs, avoidance of surgery, radiologic healing, less psychological impact, all-oral therapy, few side effects, mucosal healing, normalization of biomarkers, the relief of abdominal pain, and normalization of defecation). Patients were asked to express the level of importance to them by allocating a total of 10 points to each item. Thus, each item can be scored from 0 to a maximum of 10 points, with more points indicating more importance.
Supplementary Table 1.
Questionnaire
| Question | Answer |
|---|---|
| Age | - |
| Gender | Male |
| Female | |
| Living place | Rural |
| City | |
| Occupation | Mental labor |
| Physical labor | |
| Mixed labor | |
| Smoking status | Not smoking |
| Smoking | |
| Smoking cessation | |
| Disease type | CD |
| UC | |
| Unclassified IBD | |
| Time of diagnosis of inflammatory bowel disease | - |
| Times of visiting the hospital for treatment of IBD | - |
| Lesion site of CD | Upper digestive tract |
| Terminal ileum | |
| Colon | |
| Ileocolon | |
| Rectum | |
| Disease behavior of CD | Non-narrow and non-penetrating |
| Stenosis | |
| Penetrating | |
| Lesion site of UC | Rectum |
| Left colon | |
| Extensive colon | |
| Abdominal pain | None |
| Light | |
| Medium | |
| Serious | |
| Abdominal mass | None |
| Suspicious | |
| Confirm | |
| Tenderness | |
| Hematochezia | None |
| Seldom hematochezia | |
| Often hematochezia | |
| Always hematochezia | |
| Defecation times | 1-3 times |
| 4-6 times | |
| >6 times | |
| Extra-intestinal manifestations or comorbidity or complication | Arthritis |
| Iritis | |
| Nodular erythema | |
| Pyoderma gangrenosum | |
| Aphthous ulcer | |
| Fistula | |
| Abscess | |
| Intestinal perforation | |
| Gastrointestinal bleeding | |
| Intestinal obstruction | |
| Cancer | |
| None | |
| Drugs | 5-ASA |
| Steroid | |
| Immunosuppressant | |
| Biological agents (infliximab, adalimumab, ustekinumab, and vedolizumab) | |
| Enteral nutrition | |
| Disease phase | Active stage |
| Remission stage | |
| Whether have perianal lesions | Yes |
| No | |
| Types of perianal lesions | Anal fistula |
| Anal fissure | |
| Perianal abscess | |
| None | |
| Whether have intestinal surgery | Yes |
| No | |
| Whether have an enterostomy | Yes |
| No | |
| Self-assessment of disease status | Perfect |
| Good | |
| Bad | |
| Serious | |
| Self-reported treatment goals | Please quantify the score (0-10 points): 0 (unconcerned)-1-2-3-4-5-6-7-8-9-10 (very concerned) |
| Improvement of QoL | 0-10 |
| Few drugs | 0-10 |
| Avoidance of surgery | 0-10 |
| Radiologic healing | 0-10 |
| Less psychological impact | 0-10 |
| All-oral therapy | 0-10 |
| Few side effects | 0-10 |
| Mucosal healing | 0-10 |
| Normalization of biomarkers | 0-10 |
| The relief of abdominal pain | 0-10 |
| Normalization of defecation | 0-10 |
CD, Crohn’s disease; UC, ulcerative colitis; QoL, quality of life.
Statistical Analysis
Statistical analyses were performed by the Statistical Package for Social Sciences (SPSS) version 23.0 software (IBM Corp.; Armonk, NY, USA). All analyses were two-tailed. The value of P < .05 was considered statistically significant. Qualitative variables were described using frequency and percentage. The chi-squared test and Wilcoxon rank-sum test were performed to assess the significance of qualitative comparisons. Quantitative variables were expressed as mean and standard deviation, which were compared with Student’s t-test and analysis of variance. The factors related to the score of the questionnaire were analyzed by bivariate and multivariate logistic regression analysis. These factors with P < .05 in bivariate analysis were introduced into the stepwise selected logistic multiple regression model. The magnitude of the effect is expressed as the odds ratio (OR) (95% CI).
Results
Demographic and Clinical Characteristics
A total of 212 IBD patients (52.36% males, mean ages 43 ± 0.94) were enrolled in this study. Of them, 49 (23.11%) patients had CD, 145 (68.4%) patients had UC, and 18 (8.49%) patients had unclassified IBD; 88 (41.5%) patients were mental workers, 38 (17.9%) patients were manual workers, and 86 (40.6%) patients were mixed workers; 18 (8.5%) patients were smokers, 147 (69.3%) patients did not smoke, and 47 (22.2%) patients had quit smoking; 63.27% of CD patients are non-stenotic and non-penetrating, and most of them are in remission; 90 (42.5%) patients had mild abdominal pain and 4 (1.59%) patients had severe abdominal pain; 23 (10.85%) patients had suspicious abdominal masses and 13 (6.13%) patients had abdominal tenderness. In this survey, the most common extraintestinal manifestation in these patients with IBD was arthralgia (33.02%) (Table 1). In patients with perianal lesions, perianal abscess (48.15%) was the main symptom, followed by anal fistula (18.52%). Forty-five patients said they had undergone surgery for the disease, and 2 patients had an enterostomy. At the present stage, 72.6% of the patients thought they were in clinical remission, while 27.4% said they had fever, abdominal pain, diarrhea, hematochezia, and vomiting. From the point of view of drug selection, 78.3% of the patients chose 5-aminosalicylicacid (5-ASA) drugs.
Table 1.
The Demographic and Clinical Characteristics of IBD Patients
| Characteristics | Total (n = 212) | CD (n = 49) | UC (n = 145) | Unclassified (n = 18) |
|---|---|---|---|---|
| Age, mean (IQR) | 43 (32-54) | 37 (25-49) | 45 (34-55) | 44 (31-51) |
| Gender, n (%) | ||||
| Male | 111 (52.4) | 33 (67.3) | 67 (46.2) | 11 (61.1) |
| Female | 101 (47.6) | 16 (32.7) | 78 (53.8) | 7 (38.9) |
| Lesion site CD, n (%) | ||||
| Upper digestive tract | 5 (10.2) | |||
| Terminal ileum | 22 (44.9) | |||
| Colon | 24 (48.9) | |||
| Ileocolon | 7 (14.3) | |||
| Rectum | 6 (12.2) | |||
| Unknown | 7 (14.3) | |||
| Disease behavior CD, n (%) | ||||
| Non-narrow and non-penetrating | 31 (63.3) | |||
| Stenosis | 18 (36.7) | |||
| Penetrating | 0 (0) | |||
| Lesion site UC, n (%) | ||||
| Rectum | 77 (53.1) | |||
| Left colon | 36 (24.8) | |||
| Extensive colon | 53 (36.6) | |||
| Unknown | 22 (15.2) | |||
| Living place, n (%) | ||||
| Rural | 57 (26.9) | 11 (22.4) | 41 (28.3) | 5 (27.8) |
| City | 155 (73.1) | 38 (77.6) | 104 (71.7) | 13 (72.2) |
| Occupation, n (%) | ||||
| Mental labor | 88 (41.5) | 23 (46.9) | 60 (41.4) | 5 (27.8) |
| Physical labor | 38 (17.9) | 6 (12.2) | 27 (18.6) | 5 (27.8) |
| Mixed labor | 86 (40.6) | 20 (40.8) | 58 (40.0) | 8 (44.4) |
| Smoking status, n (%) | ||||
| Never smoked | 147 (69.3) | 34 (69.4) | 99 (68.3) | 14 (77.8) |
| Smoking | 18 (8.5) | 4 (8.2) | 11 (7.6) | 3 (16.7) |
| Given up smoking | 47 (22.2) | 11 (22.4) | 35 (24.1) | 1 (5.6) |
| Course of disease, n (%) | ||||
| ≤2 years | 118 (55.7) | 29 (59.2) | 78 (53.8) | 11 (61.1) |
| 2-5 years (>2 years, ≤5 years) | 37 (17.5) | 7 (14.3) | 27 (18.6) | 3 (16.7) |
| 5-10 years (>5 years, ≤10 years) | 24 (11.3) | 10 (20.4) | 13 (9.0) | 1 (5.6) |
| >10 years | 33 (15.6) | 3 (6.1) | 27 (18.6) | 3 (16.7) |
| Times of treatment, n (%) | ||||
| 1-3 times | 100 (47.2) | 15 (30.6) | 75 (15.9) | 10 (55.6) |
| 4-6 times | 45 (21.2) | 7 (14.3) | 33 (22.8) | 5 (27.8) |
| 7-9 times | 20 (9.4) | 8 (16.3) | 11 (7.6) | 1 (5.6) |
| >10 times | 47 (22.2) | 19 (38.8) | 26 (17.9) | 2 (11.1) |
| Abdominal pain, n (%) | ||||
| No | 102 (48.1) | 23 (46.9) | 74 (51.0) | 5 (27.8) |
| Light | 90 (42.5) | 23 (46.9) | 58 (40.0) | 9 (50.0) |
| Medium | 16 (7.5) | 3 (6.1) | 10 (6.9) | 3 (16.7) |
| Serious | 4 (1.9) | 0 (0) | 3 (2.1) | 1 (5.6) |
| Abdominal mass, n (%) | ||||
| None | 177 (79.7) | 38 (76.0) | 125 (81.7) | 14 (73.7) |
| Suspicious | 23 (10.4) | 6 (12.0) | 14 (9.2) | 3 (15.8) |
| Confirm | 9 (4.1) | 4 (8.0) | 5 (3.3) | 0 (0) |
| Tenderness | 13 (5.8) | 2 (4.0) | 9 (5.8) | 2 (10.5) |
| Hematochezia, n (%) | ||||
| No hematochezia | 124 (58.5) | 36 (73.5) | 72 (49.7) | 16 (88.9) |
| Seldom hematochezia | 61 (28.8) | 11 (22.4) | 49 (33.8) | 1 (5.6) |
| Often hematochezia | 19 (8.9) | 0 (0) | 18 (12.4) | 1 (5.6) |
| Always hematochezia | 8 (3.8) | 2 (4.1) | 6 (4.1) | 0 (0) |
| Concomitant symptoms, n (%) | ||||
| Joint pain | 70 (33.0) | 22 (40) | 43 (27.0) | 5 (25.0) |
| Iritis | 6 (2.8) | 0 (0) | 6 (3.8) | 0 (0) |
| Nodular erythema | 4 (1.9) | 1 (1.8) | 3 (1.9) | 0 (0) |
| Pyoderma gangrenosum | 4 (1.9) | 2 (3.6) | 2 (1.3) | 0 (0) |
| Aphthous ulcer | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Fistula | 2 (0.9) | 1 (1.8) | 0 (0) | 1 (5.0) |
| Abscess | 8 (3.8) | 2 (3.6) | 4 (2.5) | 2 (10.0) |
| Intestinal perforation | 1 (0.5) | 0 (0) | 0 (0) | 1 (5.0) |
| Gastrointestinal bleeding | 9 (4.3) | 2 (3.6) | 7 (4.4) | 0 (0) |
| Intestinal obstruction | 7 (3.3) | 7 (12.7) | 0 (0) | 0 (0) |
| Canceration | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| None | 123 (58.0) | 18 (32.7) | 94 (59.1) | 11 (55) |
| Drugs, n (%) | ||||
| 5-ASA | 166 (78.3) | 15 (18.7) | 136 (76.0) | 15 (71.4) |
| Steroid | 8 (3.8) | 1 (1.3) | 7 (3.9) | 0 (0) |
| Immunosuppressant | 25 (11.8) | 20 (25.0) | 5 (2.8) | 0 (0) |
| Biological preparation | 36 (16.9) | 26 (32.5) | 9 (5.0) | 1 (4.8) |
| Enteral nutrition | 45 (21.2) | 18 (22.5) | 22 (12.3) | 5 (23.8) |
| Defecation times, n (%) | ||||
| 1-2 times | 162 (76.4) | 41 (83.7) | 106 (73.1) | 15 (83.3) |
| 3-4 times | 36 (17.0) | 6 (12.2) | 28 (19.3) | 2 (11.1) |
| >5 times | 14 (6.6) | 2 (4.1) | 11 (7.6) | 1 (5.6) |
| Disease activity, n (%) | ||||
| Active disease | 25 (11.8) | 6 (12.2) | 19 (13.1) | 0 (0) |
| Clinical remission | 122 (57.5) | 26 (53.1) | 86 (59.3) | 10 (55.6) |
| Unknown | 65 (30.7) | 17 (34.7) | 40 (27.6) | 8 (44.4) |
| Perianal lesions, n (%) | ||||
| Yes | 27 (12.7) | 13 (26.5) | 8 (5.5) | 6 (33.3) |
| No | 185 (87.3) | 36 (73.5) | 137 (94.5) | 12 (66.7) |
| Types of perianal lesions, n (%) | ||||
| Anal fistula | 5 (18.5) | 3 (23.1) | 0 (0) | 2 (33.3) |
| Anal fissure | 4 (14.8) | 0 (0) | 3 (37.5) | 1 (16.7) |
| Perianal abscess | 13 (48.1) | 7 (53.8) | 3 (37.5) | 3 (50) |
| Other | 5 (18.5) | 3 (23.1) | 2 (25) | 0 (0) |
| Intestinal surgery, n (%) | ||||
| Yes | 45 (21.2) | 25 (51.0) | 17 (11.7) | 3 (16.7) |
| No | 167 (78.8) | 24 (49.0) | 128 (88.3) | 15 (83.3) |
| Enterostomy, n (%) | ||||
| Yes | 2 (0.9) | 1 (2.0) | 1 (0.7) | 0 (0) |
| No | 209 (98.6) | 47 (95.9) | 144 (99.3) | 18 (100) |
| Unknown | 1 (0.5) | 1 (2.0) | 0 (0) | 0 (0) |
CD, Crohn’s disease; IQR, interquartile range; UC, ulcerative colitis; 5-ASA, 5-aminosalicylicacid.
The Scores of Treatment Goals in Inflammatory Bowel Disease Patients
The most concerned treatment goal among these patients was the improvement of QoL (mean score is 8.54), while mean score of UC patients and CD patients was 9.10 and 8.45, respectively. The treatment goals in all IBD patients are ranked as follows (Figure 1): few drugs (8.46 score), avoidance of surgery (8.38 score), radiologic healing (8.24 score), less psychological impact (8.23 score), all-oral therapy (8.20 score), few side effects (8.19 score), mucosal healing (7.93 score), normalization of biomarkers (7.89 score), the relief of abdominal pain (7.62 score), and normalization of defecation (7.47 score).
Figure 1.
Mean points in the 11 items of inflammatory bowel disease patients’ self-reported treatment goals.
Among the patients who had undergone surgery, the most concerned treatment goal was also the improvement of QoL (8.64 score). The treatment goals in IBD patients who had undergone surgery are ranked as follows (Figure 1): radiologic healing (8.56 score), all-oral therapy (8.47 score), few drugs (8.45 score), avoidance of surgery (8.45 score), few side effects (8.36 score), less psychological impact (8.29 score), the relief of abdominal pain (8.16 score), normalization of defecation (8.13 score), mucosal healing (8.12 score), and normalization of biomarkers (7.98 score).
Univariate and Multivariate Analysis
We further analyzed the related factors of these treatment goals in IBD patients. In a univariate analysis, the related factors of the treatment goal about few drugs were the course of the disease (P = .038), the frequency of defecation (P = .004), and hematochezia (P = .047). In a multivariate analysis, the related factor of this treatment goal was the frequency of defecation (P = .01) (Table 2).
Table 2.
The Treatment Goal of Few Drugs and the Related Factors
| Univariate Logistic Regression Analysis | Multivariate Logistic Regression Analysis | |||||
|---|---|---|---|---|---|---|
| OR | 95% CI | P | OR | 95% CI | P | |
| Gender | ||||||
| Male | Ref | |||||
| Female | 0.676 | 0.3-1.522 | .344 | |||
| Disease type | ||||||
| CD | Ref | |||||
| UC | 1.406 | 0.235-8.428 | .709 | |||
| Unclassified | 0.699 | 0.150-3.255 | .648 | |||
| Age | ||||||
| ≤16 | Ref | |||||
| 16-40 (>16, ≤40) | 269.1 | 0 | .999 | |||
| 40-65 (>40, ≤65) | 1.69 | 0.177-16.118 | .648 | |||
| >65 | 0.833 | 0.095-7.304 | .869 | |||
| Living place | ||||||
| Rural | Ref | |||||
| City | 0.618 | 0.266-1.432 | .261 | |||
| Occupation | ||||||
| Mental labor | Ref | |||||
| Physical labor | 1.287 | 0.505-3.282 | .597 | |||
| Mixed labor | 0.55 | 0.201-1.502 | .243 | |||
| Smoking status | ||||||
| Never smoked | Ref | |||||
| Smoking | 2.213 | 0.927-5.283 | .074 | |||
| Given up smoking | 2.162 | 0.425-11.008 | .353 | |||
| Course of disease | ||||||
| ≤2 years | Ref | |||||
| 2-5 years (>2 years, ≤5 years) | 0.974 | 0.255-3.712 | .968 | |||
| 5-10 years (>5 years, ≤10 years) | 0.429 | 0.101-1.816 | .25 | |||
| >10 years | 0.248 | 0.055-1.064 | .06 | |||
| Times of treatment | ||||||
| 1-3 times | Ref | |||||
| 4-6 times | 0.899 | 0.322-2.508 | .839 | |||
| 7-9 times | 1.171 | 0.331-4.145 | .807 | |||
| >10 times | 0.829 | 0.186-3.705 | .806 | |||
| Abdominal pain | ||||||
| No | Ref | |||||
| Light | 6.286 | 0.818-48.316 | .077 | |||
| Medium | 6.5 | 0.835-50.594 | .074 | |||
| Serious | 161547 | 0 | .998 | |||
| Hematochezia | ||||||
| No hematochezia | Ref | 1.397 | 0.623-3.133 | .418 | ||
| Seldom hematochezia | 4.717 | 1.015-21.894 | .048 | |||
| Often hematochezia | 5.5 | 1.045-28.955 | .044 | |||
| Always hematochezia | 1.68 | 0.29-9.748 | .563 | |||
| Defecation times | 3.905 | 1.394-10.938 | .01 | |||
| 1-2 times | Ref | |||||
| 3-4 times | 5.444 | 1.615-18.358 | .006 | |||
| >5 times | 1.944 | 0.506-7.473 | .333 | |||
| Disease activity | ||||||
| Active disease | Ref | |||||
| Clinical remission | 0.724 | 0.156-3.352 | .68 | |||
| Unknown | 1.812 | 0.233-14.119 | .57 | |||
| Perianal lesions | ||||||
| Yes | Ref | |||||
| No | 2.044 | 0.457-9.149 | .35 | |||
| Intestinal surgery | ||||||
| Yes | Ref | |||||
| No | 0.986 | 0.374-2.6 | .978 | |||
CD, Crohn’s disease; OR, odds ratio; UC, ulcerative colitis.
In a univariate analysis, the related factor of the treatment goal about avoidance of surgery was the course of the disease (P = .015) (Table 3). The related factor of the treatment goal about radiologic healing was the frequency of defecation (P = .008) (Table 3). The related factor of the treatment goal about less psychological impact was the course of the disease (P = .041). The related factor of the treatment goal about few side effects was the frequency of defecation. The related factor of the treatment goal about all-oral therapy was the course of the disease (P = .001).
Table 3.
Pearson Coefficients of Correlation for IBD Patients’ Self-reported Treatment Goals
| Gender | Type | Age | Living Place | Occupation | Smoking | Course of Disease | Times of Treatment | Abdominal Pain | Hematochezia | Defecation Times | Disease Activity | Perianal Lesions | Intestinal Surgery | Enterostomy | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Normalization of defecation | 0.504 | 0.016 | 0.299 | 0.102 | 0.644 | 0.66 | 0.079 | 0.725 | 0.798 | 0.048 | 0.199 | 0.569 | 0.558 | 0.053 | 0.634 |
| Relief of abdominal pain | 0.949 | 0.135 | 0.316 | 0.256 | 0.662 | 0.755 | 0.137 | 0.62 | 0.588 | 0.055 | 0.957 | 0.306 | 0.998 | 0.305 | 0.621 |
| Normalization of biomarkers | 0.146 | 0.185 | 0.895 | 0.104 | 0.251 | 0.816 | 0.034 | 0.759 | 0.974 | 0.024 | 0.375 | 0.841 | 0.615 | 0.693 | 0.553 |
| Mucosal healing | 0.645 | 0.487 | 0.824 | 0.104 | 0.317 | 0.437 | 0.053 | 0.387 | 0.547 | 0.703 | 0.153 | 0.404 | 0.994 | 0.693 | 0.553 |
| Avoidance of surgery | 0.632 | 0.935 | 0.491 | 0.546 | 0.437 | 0.372 | 0.015 | 0.503 | 0.685 | 0.339 | 0.295 | 0.312 | 0.595 | 0.3 | 0.352 |
| Improvement of QoL | 0.851 | 0.171 | 0.4 | 0.789 | 0.3 | 0.677 | 0.109 | 0.425 | 0.317 | 0.089 | 0.079 | 0.843 | 0.492 | 0.96 | 0.209 |
| Few drugs | 0.342 | 0.439 | 0.315 | 0.258 | 0.255 | 0.18 | 0.038 | 0.962 | 0.066 | 0.047 | 0.004 | 0.972 | 0.341 | 0.979 | 0.292 |
| All-oral therapy | 0.341 | 0.758 | 0.99 | 0.402 | 0.883 | 0.109 | 0.001 | 0.828 | 0.227 | 0.366 | 0.182 | 0.125 | 0.699 | 0.412 | 0.43 |
| Few side effects | 0.219 | 0.638 | 0.594 | 0.051 | 0.562 | 0.653 | 0.068 | 0.838 | 0.184 | 0.445 | 0.033 | 0.198 | 0.524 | 0.765 | 0.484 |
| Less psychological impact | 0.904 | 0.569 | 0.503 | 0.055 | 0.537 | 0.632 | 0.041 | 0.821 | 0.214 | 0.176 | 0.1 | 0.466 | 0.8 | 0.796 | 0.4 |
| Radiologic healing | 0.158 | 0.957 | 0.711 | 0.363 | 0.568 | 0.224 | 0.068 | 0.752 | 0.056 | 0.29 | 0.008 | 0.698 | 0.908 | 0.164 | 0.368 |
IBD, inflammatory bowel disease; QoL, quality of life.
In a univariate analysis, the related factors of the treatment goal about normalization of biomarkers were the course of the disease (P = .033) and the frequency of hematochezia (P = .003). In a multivariate analysis, the related factors of this treatment goal were also the course of the disease (P = .033) and the frequency of hematochezia (P = .003) (Table 4).
Table 4.
The Treatment Goal of Normalization of Biomarkers and the Related Factors
| Univariate Logistic Regression Analysis | Multivariate Logistic Regression Analysis | |||||
|---|---|---|---|---|---|---|
| OR | 95% CI | P | OR | 95% CI | P | |
| Gender | ||||||
| Male | Ref | |||||
| Female | 0.613 | 0.316-1.189 | .148 | |||
| Disease type | ||||||
| CD | Ref | |||||
| UC | 2.828 | 0.869-9.315 | .087 | |||
| Unclassified | 2.34 | 0.838-6.538 | .105 | |||
| Age | ||||||
| ≤16 | Ref | |||||
| 16-40 (>16, ≤40) | 1 | 0.050-19.963 | 1 | |||
| 40-65 (>40, ≤65) | 0.598 | 0.067-5.313 | .645 | |||
| >65 | 0.548 | 0.063-4.473 | .585 | |||
| Living place | ||||||
| Rural | Ref | |||||
| City | 0.565 | 0.282-1.130 | .106 | |||
| Occupation | ||||||
| Mental labor | Ref | |||||
| Physical labor | 1.276 | 0.607-2.684 | .52 | |||
| Mixed labor | 0.614 | 0.262-1.442 | .263 | |||
| Smoking status | ||||||
| Never smoked | Ref | |||||
| Smoking | 1.283 | 0.596-2.760 | .524 | |||
| Given up smoking | 1.2 | 0.330-4.360 | .782 | |||
| Course of disease | ||||||
| ≤2 years | Ref | 1.47 | 1.031-2.096 | .033 | ||
| 2-5 years (>2 years, ≤5 years) | 1.778 | 0.694-4.556 | .231 | |||
| 5-10 years (>5 years, ≤10 years) | 0.591 | 0.208-1.678 | .323 | |||
| >10 years | 0.64 | 0.200-2.049 | .452 | |||
| Times of treatment | ||||||
| 1-3 times | Ref | |||||
| 4-6 times | 0.75 | .512 | ||||
| 7-9 times | 0.732 | .539 | ||||
| >10 times | 1.342 | .686 | ||||
| Abdominal pain | ||||||
| No | Ref | |||||
| Light | 1.212 | 0.12-12.23 | .87 | |||
| Medium | 1.095 | 0.108-11.09 | .939 | |||
| Seriouws | 1.444 | 0.109-19.21 | .781 | |||
| Hematochezia | ||||||
| No hematochezia | Ref | 2.262 | 1.402-4.895 | .003 | ||
| Seldom hematochezia | 4.636 | 1.076-19.974 | .04 | |||
| Often hematochezia | 3.692 | 0.811-16.804 | .091 | |||
| Always hematochezia | 1.375 | 0.282-7.220 | .707 | |||
| Defecation times | ||||||
| 1-2 times | Ref | |||||
| 3-4 times | 2.172 | 0.682-6.915 | .189 | |||
| >5 times | 1.667 | 0.442-6.291 | .451 | |||
| Disease activity | ||||||
| Active disease | Ref | |||||
| Clinical remission | 1.306 | 0.422-4.047 | .643 | |||
| Unknown | 1.206 | 0.592-2.456 | .606 | |||
| Perianal lesions | ||||||
| Yes | Ref | |||||
| No | 0.788 | 0.311-1.996 | .616 | |||
| Intestinal surgery | ||||||
| Yes | Ref | |||||
| No | 1.178 | 0.522-2.662 | .693 | |||
CD, Crohn’s disease; OR, odds ratio; UC, ulcerative colitis.
In a univariate analysis, the related factors of the treatment goal about normalization of defecation were the course of the disease (P = .016) and the frequency of hematochezia (P = .048). In a multivariate analysis, the related factors of this treatment goal were the type of disease (P = .001) and the frequency of hematochezia (P = .015) (Table 5).
Table 5.
The Treatment Goal of Normalization of Defecation and the Related Factors
| Univariate Logistic Regression Analysis | Multivariate Logistic Regression Analysis | |||||
|---|---|---|---|---|---|---|
| OR | 95% CI | P | OR | 95% CI | P | |
| Gender | ||||||
| Male | Ref | |||||
| Female | 0.812 | 0.441-1.496 | .504 | |||
| Disease | 59.241 | 9.45-371.362 | <.001 | |||
| CD | Ref | |||||
| UC | 4.318 | 1.372-13.591 | .012 | |||
| Unclassified | 3.785 | 1.388-10.320 | .009 | |||
| Age | ||||||
| ≤16 | Ref | |||||
| 16-40 (>16, ≤40) | 2619 | 0 | .999 | |||
| 40-65 (>40, ≤65) | 2.175 | 0.448-10.569 | .335 | |||
| >65 | 1.897 | 0.403-8.928 | .418 | |||
| Living place | ||||||
| Rural | Ref | |||||
| City | 1.724 | 0.893-8.327 | .104 | |||
| Occupation | ||||||
| Mental labor | Ref | |||||
| Physical labor | 1.235 | 0.626-2.438 | .543 | |||
| Mixed labor | 0.839 | 0.366-1.925 | .678 | |||
| Smoking status | ||||||
| Never smoked | Ref | |||||
| Smoking | 1.394 | 0.680-2.856 | .365 | |||
| Given up smoking | 1.219 | 0.367-4.046 | .747 | |||
| Course of disease | ||||||
| ≤2 years | Ref | |||||
| 2-5 years (>2 years, ≤5 years) | 1.703 | 0.715-4.053 | .229 | |||
| 5-10 years(>5 years, ≤10 years) | 0.638 | 0.237-1.718 | .374 | |||
| >10 years | 0.87 | 0.282-2.685 | .808 | |||
| Times of treatment | ||||||
| 1-3 times | Ref | |||||
| 4-6 times | 0.87 | 0.387-1.954 | .735 | |||
| 7-9 times | 0.611 | 0.244-1.528 | .292 | |||
| >10 times | 0.917 | 0.272-3.095 | .889 | |||
| Abdominal pain | ||||||
| No | Ref | |||||
| Light | 0.926 | 0.092-9.287 | .948 | |||
| Medium | 0.971 | 0.096-9.804 | .98 | |||
| Serious | 0.556 | 0.047-6.629 | .642 | |||
| Hematochezia | ||||||
| No hematochezia | Ref | |||||
| Seldom hematochezia | 4.238 | 0.961-18.689 | .056 | 2.239 | 1.17-4.285 | .015 |
| Often hematochezia | 7.576 | 1.571-36.529 | .012 | |||
| Always hematochezia | 3.611 | 0.642-20.320 | .145 | |||
| Defecation times | ||||||
| 1-2 times | Ref | |||||
| 3-4 times | 2.365 | 0.773-7.236 | .131 | |||
| >5 times | 1.5 | 0.423-5.315 | .53 | |||
| Disease activity | ||||||
| Active disease | Ref | |||||
| Clinical remission | 1.778 | 0.584-5.408 | .311 | |||
| Unknown | 1.25 | 0.644-2.427 | .51 | |||
| Perianal lesions | ||||||
| Yes | Ref | |||||
| No | 1.332 | 0.509-3.489 | .559 | |||
| Intestinal surgery | ||||||
| Yes | Ref | |||||
| No | 2.32 | 0.970-5.546 | .058 | |||
CD, Crohn’s disease; UC, ulcerative colitis; OR, odds ratio.
Discussion
Inflammatory bowel disease is a chronic disease that cannot be completely cured, so patients with IBD need to have better medication compliance. Otherwise, it will be recurrence or aggravation of the disease, and surgery may even be required. The medication compliance rate in adolescents was between 65% and 90% while the rate in adults was between 55% and 70%.9,10 Main related factors were low medication knowledge, no good medication habits, busy lifestyle, and concurrent mental health concerns.11 From our knowledge, this is the first study to explore these treatment goals and related factors among Chinese IBD patients during the COVID-19 pandemic. This study can provide a reference for clinicians in the management of patients with IBD during the COVID-19 pandemic.
From the perspective of patients, they would like to use the relief of symptoms as treatment goals. At the same time, some patients are more inclined to choose all-oral drugs such as mesalazine and subcutaneous drugs such as adalimumab at home because it can reduce the risk of the COVID-19 infection outdoors and in hospitals. But from the perspective of clinicians, we would like to use objective indicators as treatment goals. For example, some guidelines recommend endoscopic remission, mucosal healing, radiologic healing, and histologic healing as evaluation indicators for effective treatments. At present, radiologic healing and histologic healing are considered to be the ultimate treatment goals for patients with IBD.12 As CD involves intestinal transmural inflammation, cross-sectional radiological techniques such as computer tomography enterography and magnetic resonance imaging enterography are used to effectively evaluate this situation.13,14 Our survey also showed that 179 (84.4%) patients would like to use radiological restoration and endoscopic remission as treatment goals. Mucosal healing has been recommended as an important treatment goal for IBD patients in clinical practice.15,16 Our survey also showed that 165 (77.8%) patients would like to use mucosal healing as a treatment goal.
Clinical symptoms are also important concerns for patients with IBD. But the treatment goal of the relief of abdominal pain ranks second to last among these treatment goals by our questionnaire. Our survey showed that only 157 (74%) patients would like to use the relief of abdominal pain as a treatment goal. It is different from our understanding. The reason may be that many patients have already mastered a lot of IBD-related knowledge through patient education activities and media introduction. The disease activity of IBD patients was not only judged by clinical symptoms but also requires laboratory indicators, radiological and endoscopic evaluations. However, the symptom of hematochezia causes great attention from patients with IBD. The results of our survey also confirmed this view. Some studies found that between 7% and 10% of patients with chronic overt rectal bleeding have colorectal cancer.17 Therefore, patients are particularly worried that the symptom of hematochezia is a sign of colon cancer. At the same time, the symptom of hematochezia is an important related factor in treatment goals of normalization of biomarkers and defecation.
Some patients pay more attention to the biomarkers such as CRP and FC.18 Some studies showed that normalization of CRP was associated with therapeutic response in CD patients, and it also correlates modestly with disease activity.19 Fecal calprotectin may also be a useful adjunctive biomarker for response to therapy and to predict relapse. However, FC has relatively high testing fees and testing difficulties. Therefore, it has not been widely used by some hospitals. Our survey showed that 156 (73.6%) patients would like to use the normalization of biomarkers as a treatment goal. The related factors of this treatment goal were the course of the disease and the frequency of hematochezia. This means that patients with a long course of the disease or with the symptom of hematochezia are more inclined to choose the normalization of biomarkers as the evaluation of disease activity and treatment effect.
Therapeutic drugs for IBD patients include 5-ASA, steroids, immunomodulators, and biological agents such as infliximab and adalimumab. The choice of treatment drugs is mainly based on the severity of the patient and the location of the disease. It is also necessary to consider the adverse effects of the drug and the economic situation of patients with IBD. Oral 5-aminosalicylicacid has been shown to be effective in patients with mild or moderately active UC.20,21 Corticosteroids were effective treatments for inducing remission in moderate-to-severe CD patients. Biological agents can be effectively used to induce and maintain remission therapy in patients with IBD. Our survey found that 59.3% of patients were treated with 5-ASA, and 184 (86.8%) patients would like to use few drugs as treatment goal. The related factors of this treatment goal were the course of the disease, times of defecation, and the frequency of hematochezia. Our survey showed that 88.7% of patients were most concerned about the improvement of QoL. However, analysis of the collected data showed that there were no related factors about the treatment goal of the improvement of QoL. Our survey showed that 80.7% of patients would like few side effects as treatment goal. The related factor of this treatment goal was the times of defecation.
However, our study has several limitations. First, this study was a cross-sectional observational study, while the disease is a dynamic process of relapse and remission. There may be some dynamic changes in patients’ treatment goals, so it is difficult to evaluate the treatment goals of IBD patients accurately. Second, participants in our study were gathered from tertiary hospitals where patients were more likely to have higher disease activity, more complicated and invasive course of disease, so these patients’ self-reported treatment goals may be higher than the general population.
In conclusion, our study showed that IBD patients pay more attention to the improvement of QoL and few drugs during the COVID-19 pandemic. There are some related factors about some treatment goals such as the type of disease, the course of the disease, the frequency of hematochezia, and defecation. The results of our study can better help clinicians understand the patients’ treatment goals, which can contribute to better management of IBD patients. But we need to further explore whether these treatment goals have changed throughout the course of the disease. More studies are needed to investigate the detailed mechanisms in the future.
Footnotes
Ethics Committee Approval: Ethical approval granted by First Affiliated hospital of China medical university Research Ethics Committees (2020-032-01).
Informed Consent: Written informed consent was obtained from the patients who agreed to take part in the study.
Peer-review: Externally peer-reviewed.
Author Contributions: Concept – W.N.T., C.D.; Design – W.N.T., C.D.; Data Collection and/or Processing – W.N.T., C.D.; Analysis and/or Interpretation – W.N.T., C.D.; Writing Manuscript – W.N.T., C.D., Y.H.H., M.J.; Critical Review – W.N.T., C.D., Y.H.H., M.J.
Declaration of Interest: The authors have no conflict of interest to declare.
Funding: This research was supported by Liaoning Science and Technology Foundation (No 20170541052).
Data Availability Statement: The data underlying this article are available in the article and in its online supplementary material.
References
- 1. . Ng WK, Wong SH, Ng SC. Changing epidemiological trends of inflammatory bowel disease in Asia. Intest Res. 2016;14(2):111 119. 10.5217/ir.2016.14.2.111) [DOI] [PMC free article] [PubMed] [Google Scholar]
- 2. . Sgambato D, Miranda A, Ranaldo R, Federico A, Romano M. The role of stress in inflammatory bowel diseases. Curr Pharm Des. 2017;23(27):3997 4002. 10.2174/1381612823666170228123357) [DOI] [PubMed] [Google Scholar]
- 3. . Sairenji T, Collins KL, Evans DV. An update on inflammatory bowel disease. Prim Care. 2017;44(4):673 692. 10.1016/j.pop.2017.07.010) [DOI] [PubMed] [Google Scholar]
- 4. . Card TR, Langan SM, Chu TP. Extra-gastrointestinal manifestations of inflammatory bowel disease may be less common than previously reported. Dig Dis Sci. 2016;61(9):2619 2626. 10.1007/s10620-016-4195-1) [DOI] [PubMed] [Google Scholar]
- 5. . Tian WN, Huang YH, Dai C. The effect of the COVID-19 pandemic on the medical mode of patients with inflammatory bowel disease in China. Inflamm Bowel Dis. 2020;26(10):e116 e117. 10.1093/ibd/izaa197) [DOI] [PMC free article] [PubMed] [Google Scholar]
- 6. . Kirchgesner J, Lemaitre M, Carrat F, Zureik M, Carbonnel F, Dray-Spira R. Risk of serious and opportunistic infections associated with treatment of inflammatory bowel diseases. Gastroenterology. 2018;155(2):337 346.e10. 10.1053/j.gastro.2018.04.012) [DOI] [PubMed] [Google Scholar]
- 7. . Papa A, Gasbarrini A, Tursi A. Epidemiology and the impact of therapies on the outcome of COVID-19 in patients with inflammatory bowel disease. Am J Gastroenterol. 2020;115(10):1722 1724. 10.14309/ajg.0000000000000830) [DOI] [PMC free article] [PubMed] [Google Scholar]
- 8. . Burke KE, Kochar B, Allegretti JR, et al. Immunosuppressive therapy and risk of COVID-19 infection in patients with inflammatory bowel diseases. Inflamm Bowel Dis. 2021;27(2):155 161. 10.1093/ibd/izaa278) [DOI] [PMC free article] [PubMed] [Google Scholar]
- 9. . Greenley RN, Stephens M, Doughty A, Raboin T, Kugathasan S. Barriers to adherence among adolescents with inflammatory bowel disease. Inflamm Bowel Dis. 2010;16(1):36 41. 10.1002/ibd.20988) [DOI] [PubMed] [Google Scholar]
- 10. . Červený P, Bortlík M, Kubena A, Vlcek J, Lakatos PL, Lukás M. Nonadherence in inflammatory bowel disease: results of factor analysis. Inflamm Bowel Dis. 2007;13(10):1244 1249. 10.1002/ibd.20189) [DOI] [PubMed] [Google Scholar]
- 11. . Knowles SR, Alex G. Medication adherence across the life span in inflammatory bowel disease: implications and recommendations for nurses and other health providers. Gastroenterol Nurs. 2020;43(1):76 88. 10.1097/SGA.0000000000000467) [DOI] [PubMed] [Google Scholar]
- 12. . Peyrin–Biroulet L, Bressenot A, Kampman W. Histologic remission: the ultimate therapeutic goal in ulcerative colitis? Clin Gastroenterol Hepatol. 2014;12(6):929 34.e2. 10.1016/j.cgh.2013.07.022) [DOI] [PubMed] [Google Scholar]
- 13. . Zacharopoulou E, Craviotto V, Fiorino G, et al. Targeting the gut layers in Crohn’s disease: mucosal or transmural healing? Expert Rev Gastroenterol Hepatol. 2020;14(9):775 787. 10.1080/17474124.2020.1780914) [DOI] [PubMed] [Google Scholar]
- 14. . Saade C, Nasr L, Sharara A, et al. Crohn’s disease: a retrospective analysis between computed tomography enterography, colonoscopy, and histopathology. Radiography. 2019;25(4):349 358. 10.1016/j.radi.2019.04.007) [DOI] [PubMed] [Google Scholar]
- 15. . Peyrin-Biroulet L, Reinisch W, Colombel JF, et al. Clinical disease activity, C-reactive protein normalisation and mucosal healing in Crohn’s disease in the SONIC trial. Gut. 2014;63(1):88 95. 10.1136/gutjnl-2013-304984) [DOI] [PubMed] [Google Scholar]
- 16. . de Chambrun GP, Peyrin-Biroulet L, Lémann M, Colombel JF. Clinical implications of mucosal healing for the management of IBD. Nat Rev Gastroenterol Hepatol. 2010;7(1):15 29. 10.1038/nrgastro.2009.203) [DOI] [PubMed] [Google Scholar]
- 17. . Metcalf JV, Smith J, Jones R, Record CO. Incidence and causes of rectal bleeding in general practice as detected by colonoscopy. Br J Gen Pract. 1996;46(404):161 164. [PMC free article] [PubMed] [Google Scholar]
- 18. . Zittan E, Gralnek IM, Berns MS. The new proactive approach and precision medicine in Crohn’s disease. Biomedicines. 2020;8(7). 10.3390/biomedicines8070193) [DOI] [PMC free article] [PubMed] [Google Scholar]
- 19. . Kiss LS, Papp M, Lovasz BD, et al. High-sensitivity C-reactive protein for identification of disease phenotype, active disease, and clinical relapses in Crohn’s disease: a marker for patient classification? Inflamm Bowel Dis. 2012;18(9):1647 1654. 10.1002/ibd.21933) [DOI] [PubMed] [Google Scholar]
- 20. . Dal Buono A, Roda G, Argollo M, Paridaens K, Peyrin-Biroulet L, Danese S. Treat to target in mild to moderate ulcerative colitis: evidence to support this strategy. Curr Drug Targets. 2021;22(1):1 17 1 2 5. 10.2174/1389450121666200727120305) [DOI] [PubMed] [Google Scholar]
- 21. . Naeck-Boolauky P, Adio J, Burch J. Review of normal gastrointestinal tract, ulcerative colitis, proctitis and rectal medication adherence. Br J Nurs. 2020;29(14):805 811. 10.12968/bjon.2020.29.14.805) [DOI] [PubMed] [Google Scholar]