Patient knowledge of fecal calprotectin in inflammatory bowel disease (IBD): An observational study in Mexico

Abbreviations

IBD, Inflammatory bowel diseases; FC, Fecal Calprotectin; UC, Ulcerative Colitis; CD, Crohn’s Disease.

Introduction

Inflammatory bowel disease (IBD) is defined as a group of chronic inflammatory disorders of unknown cause that affect the gastrointestinal tract and includes two diseases: Crohn's disease (CD) and Ulcerative Colitis (UC). These diseases are defined according to clinical, radiological, endoscopic, and histological criteria, and are characterized by chronic relapses, which present in outbreaks (active phases) and periods of remission (inactive phases)¹.

Currently, gastrointestinal endoscopy, histological examination of biopsies, and contrast imaging are mandatory techniques for the diagnosis and evaluation of IBD activity. Due to the complexity of the disease and the need for a multidisciplinary approach, diagnosing and treating the condition is a challenge for medical specialists. Patients generally take five to ten years to be diagnosed, which implies that treatments are applied late and therefore, the quality of life of patients with IBD is directly affected². Patients with IBD also worry about a timely diagnosis, as well as complications of the disease and secondary conditions^3,4.

Unfortunately, endoscopy is not easily accessible in many rural areas of the Mexican Republic and when performed are sometimes unnecessary, a problem compounded by the cost of the procedure. Recently, in different international institutions the use of biomarkers or biological markers has been routinely applied. The most prominent biomarker used for IBD is fecal calprotectin (FC), which is a protein derived from neutrophils, released in the feces in response to inflammation of the intestinal mucosa. FC levels have been found to be associated with endoscopic severity, prediction of mucosal healing, and prediction of relapse; therefore, it is a useful biomarker for monitoring patient response to treatment^5,6. Additionally, a primary objective of the treatment of IBD is to improve the patient's health-related quality of life regardless of the type of therapy used. Patient knowledge of alternative methods for diagnosis and follow-up of IBD leads to increased well-being of the patients and to a reduction in overall healthcare costs⁷.

Despite the clinical utility of FC in IBD, the lack of dissemination and knowledge among patients could limit its acceptance and use as a clinical test. Currently in Mexico, there are no official statistics on the use of FC as a diagnostic marker and follow-up test for IBD. Consequently, the present study aims to assess knowledge regarding the use of FC as a diagnostic test among patients with IBD.

Methods

Results

Population characteristics

In total, 460 patients with a diagnosis of IBD were obtained in 29 states of the Mexican Republic¹⁰. The following states and cities of the Mexican Republic were the ones that provided the information: Mexico City, Mexico City (131); State of Mexico, Toluca de Lerdo (68); Monterrey, Nuevo Leon (36); Guadalajara, Jalisco (32); Coahuila, Saltillo (20); Leon, Guanajuato (16); Sinaloa, Culiacán (16); Puebla, Puebla (15); Morelos, Cuernavaca (12); Veracruz, Xalapa (12); Baja California, Mexicali (11); Chihuahua, Chihuahua (11); Pachuca, Hidalgo (9); Querétaro, Querétaro (8); Ciudad Victoria, Tamaulipas (8); Hermosillo, Sonora (7); Durango, Durango (6); Chilpancingo, Guerrero (5); Nayarit, Tepic (5); Oaxaca, Oaxaca (5); Quintana Roo, Chetumal (5); San Luis Potosí, San Luis Potosí (5); Tlaxcala, Tlaxcala (5); Yucatán, Mérida (3); Aguascalientes, Aguascalientes (2); Campeche, Campeche (2); Michoacán, Morelia (2); Zacatecas, Zacatecas (2); Tabasco, Villahermosa (1) (Figure 1).

Figure 1. States of the Mexican Republic from which participants took part.

The colours represent the number of participants recruited in each state. Mexico City and the State of Mexico (dark red) presented the greatest number of participants (over 40) with IBD. Monterrey and Guadalajara (red) presented 21 to 40 participants with IBD. The states of Coahuila, León and Sinaloa (orange) presented 21 to 40 participants with IBD. Puebla, Morelos, Veracruz, Baja Calicfornia and Chihuahua (yellow) presented 11 to 15 participants with IBD. Pachuca, Querétaro, Ciudad Victoria, Hermosillo and Durango (dark green) presented 6 to 10 participants with IBD. Chilpancingo, Nayarit, Oaxaca, Quintana Roo, San Luis Potosí, Tlaxacala, Yucatán, Aguascalientes, Campeche, Michoacán, Zacatecas and Tabasco (light green) presented 1 to 5 participants with IBD.

Table 1 shows the general characteristics of the study participants. Of the 460 patients who participated in the questionnaire, there was a greater number of patients with a diagnosis of ulcerative colitis (386; 83.9%) than Crohn’s disease (74, 16.0%), and a predominance of women (327, 71%) over men (133, 28.9%), as well as greater medical attention in the public health sector.

Table 1. General characteristics of the study population.

	Ulcerative Colitis (UC)	Crohn's disease (CD)
Number of participants (%)	83.9 % (386)	16.0 % (74)
Sex W/M	273/113	54/20
Age	42.5±11.4	48.6±5.6
Healthcare system Private/Public	165/221	25/49

Data are presented as number (%), and median/±

Discussion

To ensure high quality care for patients with a chronic disease, it is important for the patient to have adequate information on their diagnosis, treatment and follow-up, and for the doctor to inform and discuss different options with the patient. Determining patient knowledge of their disease can help reduce costs in the health sector and at the same time improve the quality of life of patients. Assessing knowledge of fecal calprotectin (CF) in patients with IBD is, therefore, important to improve patient care for this chronic disease. This study is the first to our knowledge to evaluate this in Mexico.

Participants were recruited through the “Fundación Vivir con CU y Crohn SA”, and 460 patients with a diagnosis of IBD were surveyed, of which, 83.9% were diagnosed with UC and 16.0% with CD. The predominance of UC over CD is similar to that reported in other countries in Asia and Latin American countries, such as Colombia^7,11.

In the first category of questioning about the participants’ knowledge of IBD tests, participants mostly reported to not know of any test for the state of the disease. This shows that the majority of participants were uninformed, which can lead to a deterioration in the quality of life¹². When living with a chronic disease, it is essential to know about advances in medicine, to know the signs and symptoms, and how to better diagnose and monitor the disease to improve quality of life. The benefits of staying properly informed include awareness of useful tools and tests to diagnose and prevent the advancement of the disease^11,13,14.

More than 90% of the participants stated that colonoscopy is necessary for the follow-up of IBD. Colonoscopy can be used in the initial differential diagnosis, in the surveillance of carcinoma, and to evaluate abnormalities on imaging tests. However, undergoing a colonoscopy is invasive, expensive, and intolerable for some patients. In other studies, patients have claimed to have anxiety before and during the colonoscopy, given potential risks such as intestinal perforation. Colonoscopy has also been associated with several unfavorable outcomes, including missed diagnoses and avoidable repeat procedures^15,16. In addition, it is difficult to perform an endoscopic evaluation when there is injury to the intestinal mucosa, a frequent problem in IBD^17–19.

In the second part of the questionnaire to identify the degree of knowledge of the CF test, more than 50% of the population in both groups answered that they had no knowledge of the FC test. They also said that the FC test had never been performed on them, and that their specialist doctor had never suggested performing the FC test. This highlights the scarcity of knowledge regarding this test in treating patients with IBD, and that the doctor-patient relationship seems deficient. The doctor must inform the patient of their pathology, the procedures to follow, the treatment possibilities, eventual healing and, in general, must adhere to correct clinical practice to improve the information perceived by patients^20,21.

In addition, it must be clear that the only effective information is that provided by the health professional before the intervention or treatment in question. Adequate information should be provided sufficiently in advance and be honest and easy to understand, so that the patient can make an informed decision²². That is why the dissemination of information to the patient, including the benefits and disadvantages of any potential procedure should be made known²³.

The study participants were questioned about the accessibility of the FC test in their medical unit. More than 70% stated that it was difficult to access this test, and in contrast, more than 50% of the population reported not knowing whether this test is available in their medical unit. The Mexican Consensus for the diagnosis and treatment of IBD suggests that the FC test is useful to evaluate the activity of IBD. The test’s response to medical treatment correlates with mucosal scarring or endoscopic remission, and is a good predictor of relapse, so access should be easily available in any medical unit²⁴. Furthermore, expert guidelines suggest that disease activity should be reassessed every 3 to 6 months²⁵, therefore, it would be important for public and private medical units to have the FC test for regular cost-effective testing^17,26.

In questions about the cost of FC, more than 60% of participants stated that they did not know the cost of the test, and more than 60% believed that the price of FC is less than a colonoscopy. On the contrary, a study carried out by Motaganahalli et al., in 2019, suggests that the introduction of the FC test in the routine health care of IBD not only helps the patient, but is potentially cheaper than a colonoscopy²⁷. The use of colonoscopies could be reduced by more than 80% if the FC test is used as the first approach²⁸. In addition, the use of the FC test over a colonoscopy would be more profitable, indirectly, for the patient, since colonoscopies cause loss of productivity and absence from work, require sedation and attendance at a medical care center^29,30.

Finally, the participants were questioned about which test they would prefer to carry out for an IBD follow-up appointment. More than 80% stated that they would prefer the FC test. FC could not only be useful in the differentiation of patients with active IBD and those in remission, but it also correlates well with the degree of inflammatory activity evaluated by clinical indices such as endoscopy and histology, and predicts clinical relapse, as well as the mucosal healing and postoperative recurrence^31,32. Other authors have shown that FC levels are associated with the presence of histological alterations in endoscopic biopsies, being lower in the absence of anatomopathological inflammation^33–35. In different cohorts it has also been reported that the FC test is able to distinguish IBD from Irritable Bowel Syndrome^36,37. Therefore, the use of an alternative non-invasive biomarker such as FC that can accurately differentiate functional or organic diseases, detect inflammation of the intestinal mucosa, and monitor disease activity to avoid invasive and costly testing could be highly useful^38,39.

Assessing patient knowledge of non-invasive tests such as FC in patients with IBD may help to improve patient care as well as a reduction in medical costs during follow-up of the disease. This study suggests that knowledge of such tests can be improved with better communication with the medical personnel. The limitations of the study were that there was a much greater number of participants with ulcerative colitis than Crohn’s disease, and the patients were only evaluated cross-sectionally.

In general, patients with chronic diseases should know about the tests that help to diagnose and monitor their disease. For IBD, assessing a biological biomarker, such as FC, is more specific than clinical indices, less expensive, more comfortable than endoscopic monitoring, and reduces the need for endoscopic examinations. Therefore, patients with IBD should be given the correct information on the use of FC which could be a valid alternative to evaluate the response to treatment and reduce the number of colonoscopies performed. To improve knowledge transfer to patients, we suggest improving accessibility to services, creating comprehensive care units, having medical specialists inform their patients about management of the disease, promoting medical research on the disease, and likewise, raising more awareness in society about IBD.

Conclusion

Using the application of a questionnaire, we evaluated the knowledge of patients with IBD about the diagnostic tests that are required for the diagnosis and follow-up of the disease. There was a lack of awareness of the effective and low-cost Fecal Calprotectin test in the participants. In order for patients to make informed decisions regarding the management of their disease, doctors should provide adequate and timely information about the different options available.

Data availability

Consent

Written informed consent for publication of the participants’ details was obtained from participants.