Study design
This prospective cohort study was conducted on adults between July 2022 and February 2023. At the time of the study, China was tough on COVID-19 dominated by Omicron [14, 15], a variant of SARS-CoV-2 and all people were in a population-wide COVID screening in hospital or community with regular universal reverse transcription polymerase chain reaction (RT-PCR) test. All suspicious COVID persons even for asymptomatic infection were referred to local hospitals or large square cabin hospitals for mandatory quarantine. All suspicious infected persons undergoing a diagnostic procedure, such as a nasopharyngeal polymerase chain reaction (PCR) test or chest radiograph to show their lung involvement, had a definite diagnosis of coronavirus infection by their physician. Patients with COVID−19 are included in the study according to inclusion or exclusion criteria as soon as the diagnosis of COVID−19 is confirmed. Gastroenteroscopy including endoscopic biopsy, blood sampling(Blood count, white blood cell count, CPR, PCT, IL−6, IgG and IgM antibody tests for viruses) and other tests (X-rays and ultrasound, Urine routine, stool routine) were needed to exclude other bacterial and viral infections in the whole body or any part of the body or acute gastroenteritis (AG) that could cause GI symptoms. The lag time from diagnosis of COVID−19 to study inclusion is no more than 1 day. All patients received the national protocol of standard treatment without changes.
It consisted of 2 cohorts, a case group that included COVID-19 patients consecutively recruited from Fangcai Hospital, a dedicated COVID care center, in Haikou of Hainan Province, China. Healthy control group included COVID serology negative screeners at our hospital in the same time period. Participants were followed up either outpatient physical or over the telephone at 1, 3, and 6 months using validated Rome III and Rome IV questionnaire and limited objective assessment [1]. The follow-up period from July-August 2022 to February 2023 was more than 6 months. The data from case groups were compared with the 6-month follow-up data on the development of FGID in an age- and sex-matched cohort of healthy subjects. In addition, subjects who met the various diagnostic criteria for FGID in Rome at 6 months of follow-up were advised to come to the clinic for further examination by laboratory and endoscopic methods as well as clinical indications to exclude some diseases such as gastroparesis, SIBO, microscopic colitis, etc. Clinical indicators include duration and frequency of diarrhea, consistency of stool and presence of blood, history of vomiting, fever, cramping abdominal pain and weight loss. The included COVID-19 patients and healthy controls were tested for COVID-19 at 3 and 6 months to exclude COVID-19 reinfection. The questionnaires also included co-morbidities (Hypertension or diabetes), anxiety, irregular diet, sleep quality, and regular exercise sections.
Inclusion criteria of case group were as follows: (1) age between 18 and 85 years old, having a definitive diagnosis of coronavirus with different severity [16, 17] (mild and moderate) using biochemical test data (such as COVID19-SARS-CoV-2 positive, and anti-SARS-CoV-19 IgG and IgM negative) or computed tomography scan of chest and observation of lung involvement;(2) no previous history of clinical confirmation of the diagnosis of any FGID, no GI tumors, reflux esophagitis, ulcerative colitis or other GI diseases, no co-morbidities (Hypertension or diabetes), no history of abdominal surgery, and no any recurrent baseline symptoms of FGID or GI symptoms such as diarrhea, constipation, or abdominal pain; (3) blood sampling, and other tests were needed to exclude AG, bacterial and viral infections;(4) normal findings of gastroscopy and other laboratory tests from the last 6 months of medical examination were required. Healthy control group had no history of COVID-19 or FGID. Biochemical test data (such as COVID19-SARS-CoV-2 negative, and anti-SARS-CoV-19 IgG and IgM negative) are required and the rest of the criteria were the same as for the case group.
The objectives of this study were explained in detail to all participants, and also, partici-pating in this study was fully conscious and based on their desire. Further, written informed consent was obtained from each participant. Meanwhile, Each participant provided a written or electronic informed consent form and the study was approved by the institutional ethics committee of the Second Hospital of Hainan Medical University (reference number: LW2022270).
Definitions
RT-PCR was used to detect SARS-CoV-2 in nasopharyngeal and oropharyngeal samples of subjects [18]. The diagnosis of IBS by the Rome IV diagnostic criteria has changed significantly, the new diagnostic criteria have increased the frequency required to diagnose IBS, and the incidence of IBS has decreased [1]. We used Rome III rather than the most recently described Rome IV criteria as the latter is 50% less sensitive to diagnose IBS [1]. Other types of FGID were diagnosed based on the Rome IV criteria [1].
Dyspepsia refer to postprandial discomfort syndrome, which often manifests itself as postprandial fullness and early satiety (inability to complete a normal meal). Dyspepsia means the same as Functional dyspepsia, and refers only to postprandial discomfort syndrome.
AG was defined as the presence of at least two of the followings: (i) diarrhea, (ii) vomiting, (iii) fever, and (iv) stool culture isolating entero-pathogens [6]. Stool sample of each COVID-19 patient was examined under a microscope for detection of pus cell, RBC or parasites. All suspected stool samples were cultured for Vibrio cholerae, Salmonella, Shigella, Campylobacter and Aeromonas using standard techniques to identify the pathogenic strains.
Patients who showed signs of organ failure (such as persistent oliguria, severe respiratory distress) or required ventilator support or admission to an intensive care unit during treatment for COVID-19 infection were defined as having severe COVID-19. The severity of the COVID-19 [16, 17, 19] was assessed as described: (i) critical (required ventilator), (ii) severe (needed oxygen), (iii) moderate (though pneumonia present, did not require oxygen), and (iv) mild (only upper respiratory symptoms). Those without symptoms at the time of diagnosis of COVID-19 were classified as asymptomatic as categorical variables (yes or no).
Living with frequent (> 5 times/month) infrequent meals and irregular meal times was defined as an irregular diet. The Pittsburgh Sleep Quality Index (PSQI) [20] was used to investigate the sleep quality of patients. The total score of PSQI ranges from 0 to 21, where 7 is the threshold value of sleep quality problem, and the higher score above 7 indicates the poorer sleep quality of the patients, while the opposite indicates the better sleep quality of the patients. Regular exercise is defined by the latest World Health Organization (WHO) Guidelines for Exercise and Sedentary Behavior 2020 [21]. Adults should engage in at least 150–300 min of moderate-intensity aerobic exercise per week, or at least 75–150 min of high-intensity aerobic activity, or an equivalent combination of moderate-intensity and high-intensity exercise; Older adults should have at least 150–300 min of moderate intensity aerobic exercise per week, or at least 75–150 min of high intensity aerobic exercise, or an equivalent combination of moderate and high intensity exercise. The Hamilton Anxiety Scale [22] was used to evaluate the psychological status of the case group, and possible anxiety was considered when the scale score was > 7.
Statistical analysis
Sample size calculation
In this study, the sample size was calculated as 90% power, 99% confidence interval (bilateral) based on previous studies [12, 23, 24] that showed that the mean incidence of FGIDs after acute gastroenteritis is about 21% and a Chinese study that showed the incidence of PI-FGIDs in controls of 8.2% [25]. A total of 155 COVID-19 patients and 155 healthy controls were required in this study, while 194 COVID-19 patients and 194 controls were enrolled since about 10–20% loss could occur at follow-up. Four of 194 COVID-19 patients and 34 of 194 healthy controls were excluded because they had inadequate documentation or were lost during follow-up. Finally, 190 COVID-19 patients and 160 healthy controls were analyzed (Fig. 1).
Data collection and analysis
SPSS (version 26; SPSS Inc, Chicago, IL) was used for all statistical analyses. Categorical data were presented as proportions, while continuous data were expressed as mean ± standard deviation (SD) or median and range or interquartile range (IQR). Categorical variables were analyzed using χ2 test with Yates correction, where applicable. Parametric and nonparametric continuous data were analyzed using unpaired t-test and Mann-Whitney U test, respectively. Multivariate analysis was performed using stepwise logistic regression. A two-tailed P value < 0.05 was considered significant.
Post-infection functional gastrointestinal disorders following coronavirus disease-19: a prospective follow-up cohort study - BMC Infectious Diseases - BMC Infectious Diseases
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