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IBDoc® in Clinical Practice

Fecal calprotectin is an ideal non-invasive marker to monitor inflammation in the gut for patients suffering from IBD. Since IBD is a chronic condition, remote disease monitoring offers patients to facilitate their disease management and working lives since less hospital visits are needed. Further, hospital visits always bear the risk of potential infections, not only COVID-19, so reducing numbers of hospital visits is a benefit for chronic disease patients. But not only patients can benefit from remote disease monitoring, but also clinics can free up consultant time for patients who are really in need of clinical visits.

IBDoc®, a smartphone based application for fecal calprotectin testing, offers the perfect solution for IBD patients to monitor their disease at home. At ECCO 2020 in Barcelona we had the chance to talk with Kathleen Sugrue from Mercy University Hospital in Cork, Ireland and Pearly Avery from Dorset County Hospital in the UK about the use of IBDoc® in clinical practice.

IBDoc® calprotectin in clinical practice- teaser

ECCO 2020 interview with Kathleen Sugrue about the daily use of IBDoc® at the Mercy University Hospital

ECCO 2020 interview with Pearl Avery about the daily use of IBDoc® at the Dorset County Hospital

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IBDoc® News from ECCO 2020

At ECCO 2020, IBDoc® was again under the spotlight as 2 very interesting posters were presented. After 5 years of market presence, long term data about the impact of IBDoc® usage in clinical routine are beginning to emerge. Improving quality of life of IBD patients is extremely important, developing tools to allow patients to have a higher sense of control over their disease is now a must, especially for chronic diseases. Kathleen Sugrue assessed this in her poster at ECCO 2020.

Figure 1 Actions of patients having moderate or high IBDoc® results

At Mercy University Hospital, the goal of the study was to assess the impact of IBDoc® in clinical practice. Since 2014, 733 patients were enrolled in the IBDoc® program. The clinic now has sufficient experience with this tool to allow an evaluation. The patients were allowed to stay at home and came to the hospital for further evaluation only if the IBDoc® result was elevated (>100µg/g). Over the last 6 months, a total of 240 tests were performed by patients. Of those, 40% were normal, 40% were moderate and 20% were high. Only the patients with a moderate or a high result were scheduled for an appointment at the hospital within a week. Of the moderate, 20% had a change of therapy and of the high results, all patients were booked for an urgent colonoscopy and all were found to have an active disease.

This study has several outcomes. First of all, the IBDoc® set-up allows to free-up time both on the patient side, who is no longer coming to the hospital, and on the hospital side, where the care givers could now focus more on patients with active diseases. The patients are only coming to the clinic when it is needed, enhancing the patients quality of life. Next, we can see that IBDoc® has a 100% correlation with endoscopy, which makes it an excellent tool for patient monitoring and allows the fast track system in clinical practice.

On the same topic, an internal audit was conducted at Dorset County Hospital to evaluate the efficiency of IBDoc®, which is used there since 2016. Pearl Avery presented the audit findings in her ECCO 2020 poster to better assess the benefit for patients and hospitals. The study is a retrospective evaluation of the most recent results generated with IBDoc®. Correlation between fecal calprotectin and endoscopy or patient disease state was then evaluated.

Over the last 6 months, 134 patients were registered to use IBDoc®. Of those, 111 patients generated a result. Based on this result, 31 patients were scheduled for a colonoscopy and an 84% correlation between fecal calprotectin and colonoscopy was found. It is important to note that, for high results generated with IBDoc®, correlation goes up to 100%. In patients having normal colonoscopy result but a high calprotectin value, other reasons for the high calprotectin was found, such as C.difficile infections and others. Of the 80 patients with no colonoscopy, disease status was assessed and 39 patients were deemed well, 19 needed a tighter monitoring and 23 needed a change of therapy. These outcomes correlate very well with IBDoc® thresholds: Normal (<150), Moderate (150-400) and High (>400).

Table.1 Correlation of IBDoc® results and colonoscopy outcome

As for the first poster, the aim was here to demonstrate the good correlation between IBDoc® and endoscopy. This allows to better identify the patients in need for further evaluation and those who don’t, increasing time management for both the clinic and the patient.

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Fecal calprotectin- a small protein of high importance

Worldwide more than 6.8 million people live with Inflammatory Bowel Disease (IBD) which is characterized by chronic inflammation of the gastrointestinal tract. The highest numbers of IBD patients are observed in North America and Europe with an estimated 2.2 million affected persons in North America and an estimated 0.3% of the European population suffering from IBD (1, 5, 9, 11). In Europe, epidemiological studies suggest both a north-west gradient with more IBD patients in the north and a west-east gradient with more patients in the west. Thereby both, the incidence and prevalence are still increasing (1, 9. 13).

Crohn`s disease (CD) and ulcerative colitis (UC) are the two major forms of IBD, both characterized by inflammation of intestinal mucosa and a chronic, relapsing disease course. Thereby periods with high disease activity and acute symptoms alternate with phases of remission, with slight or no symptoms (14, 15). Ulcerative colitis normally starts with mucosal inflammation at the rectum which extends continuously upwards through the colon. Thereby only the inner lining of the colon is inflamed. In contrast, in Crohn`s disease the inflammation can affect entire intestinal layers and inflammations can occur anywhere in the gastrointestinal tract, from mouth to anus. Thereby inflammation is typically segmental, meaning that several patches of inflammation are interspersed between healthy portions of the gut. The exact cause of IBD remains unknown, although it is suggested that several aspects such as genetic and environmental factors may play a role (13, 14, 15).

What is calprotectin?

Calprotectin is a cytosolic protein particularly present in neutrophil granulocytes. These are specialized cells of leucocytes belonging to the non-specific immune response in the human body and play a major role in inflammatory reactions. Depending on the localization of the inflammation, calprotectin can be found in different body fluids and in serum. When there is an inflammation in the gastrointestinal tract, neutrophil granulocytes migrate from the circulation to the intestinal mucosa. They accumulate at the site of inflammation and calprotectin is released into the intestinal lumen. While feces migrate towards the anus, it gets into contact with calprotectin. This can be measured in secreted stool using different tests (6, 10, 16).

Inflammatory alterations in the intestine, as they occur in Crohn`s disease and ulcerative colitis, lead to elevated calprotectin concentrations in stool. Thereby the severity of intestinal inflammation correlates well with the concentration of calprotectin in feces. Thus, fecal calprotectin is an ideal non-invasive biomarker to identify intestinal inflammation throughout the gastrointestinal tract. It has the ability to distinguish organic disease like IBD from non-organic disorders such as Irritable Bowel Syndrome (IBS) in patients suffering from gastrointestinal symptoms like diarrhea or chronic abdominal pain. For the initial diagnosis of IBD a combination of clinical, biochemical, stool, endoscopic and histological investigations is needed (2, 6, 8, 10, 16).

For what else can we use calprotectin?

After initial diagnosis of Crohn`s disease or ulcerative colitis the intestinal inflammation is treated using different medications. Since fecal calprotectin reflects the inflammatory status of the disease, it decreases as soon as the intestinal inflammation gets better. It was shown that fecal calprotectin not only correlates well with endoscopic disease activity, but also with mucosal healing (2, 4, 6, 8, 12). Thus, measuring calprotectin levels in stool is a good tool to monitor disease activity and assess the treatment success in IBD patients. Therefore, the number of invasive colonoscopies, which are time consuming and uncomfortable for patients, can be reduced for disease monitoring 16.

Most IBD patients experience periods of remission alternating with flares of variable severity. The aim is to maintain clinical remission, since a failure to control inflammation is associated with impaired quality of life as well as worse long-term outcomes. Several studies showed that an increase of fecal calprotectin in patients in clinical remission was associated with an increased risk of relapse. Thereby, it can increase months before a relapse, when patients still experience physical well-being and feel healthy (2, 6, 7, 8, 16).

How is calprotectin measured?

Today, most of the patients collect a sample of stool into a stool collection tube and bring it personally or send it to their gastroenterologists, to the hospital or directly to the labs. Patients receive the results from their healthcare professionals within a few days. The stool sample is stable for up to several days at room temperature. Nowadays, there are specialised stool sampling devices which already dissolve the stool into a buffer, making it more stable and ready to measure the sample in the lab right away without the need to extract the stool manually. Another possibility is to use smartphone based calprotectin home tests which allow patients to measure their fecal calprotectin at their homes. Patients can see their test results directly on their smartphone using an app and healthcare professionals are informed automatically about the performed test. This solution offers a fast, flexible and independent measurement of the inflammatory marker for patients at home without the need for hospital visits. In these days, where patients should rather stay at home because of the current COVID-19 pandemic, such solutions can be very helpful (3, 7, 16).

References

  1. Burisch, J. et al., 2013, The burden of inflammatory bowel disease in Europe, Journal of Crohn`s and Colitis
  2. Burri, E. et al., 2012, Fecal calprotectin-a useful tool in the management of inflammatory bowel disease, Swiss Medical Weekly
  3. COVID-19 ECCO Taskforce, published March 20, 2020
  4. Hart, L. et al., 2020, Faecal Calprotectin Predicts Endoscopic and Histological Activity in Clinically Quiescent Ulcerative Colitis, Journal of Crohn‘s and Colitis
  5. Jairath, V. et al., 2020, Global burden of inflammatory bowel disease, Lancet Gastroenterology & Hepatology
  6. Kostas, A. et al., 2017, Fecal calprotectin measurement is a marker of short-term clinical outcome and presence of mucosal healing in patients with inflammatory bowel disease, World Journal of Gastroenetrology
  7. Louis Edouard, 2015, Fecal calprotectin: towards a standardized use for inflammatory bowel disease management in routine practice, Journal of Crohn’s and Colitis
  8. Maaser, C. et al., 2019, ECCO-ESGAR Guideline for Diagnostic Assessment in IBD Part 1: Initial diagnosis, monitoring of known IBD, detection of complications, Journal of Crohn‘s and Colitis
  9. Mak, W. Y. et al., 2019, The epidemiology of inflammatory bowel disease : East meets west, Journal of Gastroenterology and Hepatology
  10. Manz, M. et al., 2012, Value of fecal calprotectin in the evaluation of patients with abdominal discomfort: an observational study, BMC Gastroenterology
  11. Ng, S. C., et al., 2017, Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century : a systematic review of population-based studies, Lancet
  12. Penna, F.G.C. et al., 2020,Faecal calprotectin is the biomarker that best distinguishes remission from different degrees of endoscopic activity in Crohn’s disease, BMC Gastroenterology
  13. Rogler, G.et al., 2018, New insights into the pathophysiology of inflammatory bowel disease: microbiota, epigenetics and common signalling pathways, Swiss Medical Weekly
  14. Torres, J. et al., 2017, Crohn`s disease, Lancet
  15. Ungaro, R. et al., 2017, Ulcerative colitis, Lancet
  16. Walsham and Sherwood, 2016, Fecal calprotectin in inflammatory bowel disease, Clinical and Experimental Gastroenterology

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IBD and COVID-19

Because of the current situation with the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing the COVID-19 disease it is important to keep IBD patients out of clinics whenever possible. Nevertheless, tight monitoring of inflammation level in the gut is needed to deal with these chronic conditions. Calprotectin has proven to be an ideal non-invasive biomarker to monitor inflammatory bowel diseases. IBDoc®, a smartphone based application for fecal calprotectin testing at home, offers the perfect solution to to keep patients out of clinics while still being able to monitor their disease. Click on the link below to read an overview on the benefits of calprotectin home testing.

Start using IBDoc® today

To help you get started quickly, we have a wide selection of information material, including online resources for remote training, to support Healthcare Professionals and patients when they start using IBDoc®. Several quick and easy IBDoc® portal tutorial videos exist to help Healthcare Professionals with the first steps of creating an account and setting up new users.

We renewed our information brochure for patients where they can find all necessary informations for the smartphone based fecal calprotectin home testing application. This should help the Healthcare Professionals to present IBDoc® to their patients.

Patient home test IBDoc® to prevent hospital visits

After 5 years of market presence long term data become available showing the ease of use of this smartphone-based application and the benefits for patients and clinics. Two excellent posters were presented by K.Sugrue and P. Avery at ECCO 2020 about how IBDoc® can impact patient`s disease management and how the home test can optimize the time management in clinics.

Stay safe and healthy!!!

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Fecal Calprotectin Home Testing in 2020

The use of fecal calprotectin (fCAL) in clinical routine is demonstrated beyond doubt. We now have extensive knowledge of its efficacy for IBD/IBS differentiation and IBD monitoring, as it has been shown to be an excellent surrogate biomarker for inflammatory status of the gut that correlates well with endoscopic activities (1). The key benefit of measuring fCAL is in avoiding unnecessary endoscopies to patients, which are uncomfortable, painful, time consuming and costly (2).

In 2015, IBDoc® the first home test kit for fCAL obtained the CE marking and took monitoring of IBD patients to a new level. IBDoc® was proven to be as efficient as a lab test (3, 4, 5) and very well accepted by patients in several countries 6, 7, 8. In addition to avoid unnecessary procedures, home testing can avoid hospital visits altogether for the patients. This not only saves time for both, the patients and the healthcare professionals, but also reduces costs. Over the years data on routine usage of IBDoc® has become more and more available. Two posters were recently published at ECCO 2020 and both came to the same conclusion: home testing is perfect to discriminate patients who need immediate care from those who do not (9, 10). As technology continues to improve, patients are now monitored from afar in virtual clinics until they need a physical appointment.

2020 just barely started when a novel event also brought focus on home testing. As the new coronavirus (SARS-CoV-2) continues to spread at an increasing speed, hospitals and whole countries are shutting down to avoid contaminations in an attempt to decrease the numbers of infected people suffering from COVID-19 (11). Early data showed that many of the initially infected people were hospital staff or hospitalized patients (12). Because of this and general social distancing measures, IBD patients are asked to stay at home but it is still recommended that the fCAL monitoring is continued. The European Crohn’s and Colitis Organisation (ECCO) gathered a group of gastroenterologists to address the questions about this global pandemic and to give guidance on how to proceed in this particular situation (13). Additionally, data on IBD patients that have contracted COVID-19 is continually added to the SECURE-IBD registry. The main goal is to prevent patients from going to the hospital, and as a result the priority for the physicians is to set-up virtual clinics to follow their patients from distance. This means frequent phone calls to assess the clinical symptoms, to reduce endoscopic procedures for patients with moderate-to-severe symptoms and to perform fCAL home testing to determine the inflammatory status of the gut. This approach has been assessed and proven to be as efficient as a standard clinical care with hospital appointments (14). The benefits of remote monitoring in the care of patients with chronic diseases for the health care system are obvious and gradually on the way to becoming the new standard of care. The current situation highlights one of the benefits and might help to accelerate the shift to more remote monitoring. Even outside of a pandemic shut-down situation it is a good idea to reduce hospital visits due to potential infection risks. Chronic disease patients are also not always fully mobile and it is not always easy to take time of work to organize hospital travel.

  1. Rosenfeld, G. et al. FOCUS: Future of fecal calprotectin utility study in inflammatory bowel disease. World J. Gastroenterol. 22, 8211–8218 (2016). http://dx.doi.org/10.3748/wjg.v22.i36.8211
  2. Yang, Z., Clark, N. & Park, K. T. Effectiveness and cost-effectiveness of measuring fecal calprotectin in diagnosis of inflammatory bowel disease in adults and children. Gastroenterol. Hepatol. 12, 253–62.e2 (2014). http://dx.doi.org/10.1016/j.cgh.2013.06.028
  3. Ungar B. et. al., 2017, Home smart-phone based measurement of fecal calprotectin by IBD patients: correlation with laboratory assay and applicability as patient-friendly monitoring too, ECCO 2017 Poster.
  4. Hejl J. et al., 2017, Point of care testing of fecal calprotectin as a substitute for routine laboratory analysis, Practical Laboratory Medicine.
  5. Heida A. et al., 2017, Agreement Between Home-based Measurement of Stool Calprotectin and ELISA Results for Monitoring Inflammatory Bowel Disease Activity, Clin Gastroenterology and Hepatology.
  6. Bello C. et al., 2017, Usability of a home-based test for the measurement of fecal calprotectin in asymptomatic IBD patients, Digestive and Liver Disease, 2017.
  7. Wei S. et al., 2018, Experience of patients with inflammatory bowel disease in using a home fecal calprotectin test as an objective reported outcome for self-monitoring, Intestinal Research.
  8. Moore AC. et al., 2018, IBDoc® Canadian User Performance Evaluation, Inflammatory Bowel Diseases.
  9. Avery P. et al., 2020, IBDoc® Faecal calprotectin self-test retrospective audit in a District General Hospital (DGH), ECCO 2020 Poster.
  10. Sugrue K. et al., 2020, An evaluation of the impact of IBDoc® in clinical practice 5 years after introduction, ECCO 2020 Poster.
  11. Huang C. et al., 2020, Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China, The Lancet.
  12. Wang D. et al., 2020, Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus–Infected Pneumonia in Wuhan, China, JAMA
  13. COVID-19 ECCO Taskforce, published March 20, 2020
  14. McCombie et al., 2019, A Noninferiority Randomized Clinical Trial of the Use of the Smartphone-Based Health Applications IBDsmart and IBDoc in the Care of Inflammatory Bowel Disease Patients, Inflammatory Bowel Disease, 2019

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IBDoc® in French TV

Allô docteurs is a French medical TV show, covering new topics every day to help patients dealing with their disease. On the 3rd of February 2020, the show was  about “living with IBD”.

A 3 minute story was presented on how healthcare professionals and patients are using IBDoc®, the fecal calprotectin home test, to improve their control over the disease.

On the healthcare professional side, IBDoc® is used to monitor fecal calprotectin closely. If the result is high, the patient is followed-up and measures are taken as soon as possible to prevent a relapse.

On the patient side, IBDoc® is deemed helpful to improve the quality of life. Indeed, patients are no longer needed to go to the hospital as long as their fecal calprotectin levels are normal. IBDoc® allows them to be more autonomous and saves them time.

 

 

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IBDoc Update

New IBDoc® Tutorial Videos

We created six new IBDoc® Portal Tutorial Videos. They help Healthcare Professionals that start using IBDoc® with the first steps of creating an account and setting up new users.

Updated IBDoc® Flyer

This flyer can be used to easily demonstrate the efficiency and practicality of IBDoc®.  It was updated to better reflect the current status of IBDoc®: we now support a total of 60 validated smartphones.

Updated IBDoc® Smartphone List

During Summer 2019, we received approval from our notified body TÜV Süd to add 8 new smartphone models to be used with IBDoc®, bringing us to a total of 60 validated smartphones. We now support the latest iPhones with the Xs series and we continue to expand the Huawei coverage, responding to an increasing demand for this brand.

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One Year using IBDoc®, a Patients View

A very proactive patient in the UK suffering from Crohn`s disease wanted to share the story of his use of IBDoc® after one year. For the past 27 years, he tried every kind of medication available. Only a very strict diet based on rice, chicken and carrots associated with a therapeutic monoclonal antibody allowed him to manage his Crohn’s disease.

Even with this plan, a question is still hanging in his head: If I have an occurrence of symptoms, are they due to a flare or another reason? This is when IBDoc® is useful to him: by obtaining immediate results of actual calprotectin levels there is no need to panic that things are moving out of control. Monitoring his calprotectin value every month with IBDoc® showed him that he was on a steady state and avoided him unnecessary stress.

“IBDoc® has reduced the “waiting time” for results down to hours instead of days or weeks.”

“I believe what IBDoc® has allowed me to do over the course of the last year is fundamentally educate myself in understanding my disease state.”

“Having Crohn’s disease for twenty-seven years has taught me many things; fundamentally that patients need to self manage and IBDoc® is one powerful tool in my self-managing tool kit.”

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Four Years of experience using IBDoc®

The Mercy University Hospital in Cork was the first hospital to introduce the BÜHLMANN IBDoc® self-testing in routine. After 4 years of use they can show the real benefit of IBDoc® for patients and the clinic. One of their most important finding was the number of unnecessary procedures avoided for patients. On a study of 131 patients using IBDoc®, a total of 53 clinic visits and 62 colonoscopies were not required, reducing the burden of patients with IBD.

“Since introducing IBDoc® we get less calls on the helpline because patients can check themselves if they are concerned they are flaring.”

“Patients love the IBDoc® and have become reliant on it for self-managing their disease.”

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Latest IBDoc® Publications from ECCO 2019

At this years ECCO the ECCO IBD guidelines were updated to include a statement to use fecal calprotectin (fCAL) in IBD monitoring. This means that IBD patients will do many calprotectin measurements over their disease course. At the same time as in all chronic disease the therapy follow-up is more and more done remotely decreasing the time patients with a stable disease course spend at hospitals and allowing the IBD care team to focus their time on patients that actually need it. Therefore fecal home tests have become more and more frequent as part of the clinic routine. With several solutions from different manufacturers there is a need to compare them in regard of accuracy and usability to make sure that the offered home tests are easy to use for patients and deliver accurate results on which the IBD care team can base clinical decisions on. Haisma et al. did exactly that and presented a poster at ECCO that was published in PLOS One shortly after the congress.  Dr. Sjoukje Haisma also presented her poster on video (see below).

They compared three home tests (IBDoc®, QuantonCal and CalproSmart) and companion ELISA tests fCAL, IDK-Calprotectin and Calprotectin-ALP) to see if measurement pairs agreed sufficiently. In a method comparison study with stool samples from patients with active or quiescent inflammatory bowel disease medical students without any specific laboratory training carried out the home tests with two iOS and two Android devices. Two experienced laboratory technicians measured the calprotectin concentration with the ELISA methods.

They performed a total of 1440 smartphone readings and 120 ELISA tests. In the low calprotectin range (<500 μg/g) IBDoc®, QuantOnCal and CalproSmart showed 87%, 82% and 76% agreement with their companion ELISAs. In the high range (>500 μg/g) the agreement was 37%, 19% and 37%, respectively. Overall IBDoc showed the best clinical concordance with 82% of all measurements resulting in the same clinical interpretation as the companion ELISA. To assess user-friendliness the students filled in standardized system usability scale (SUS) scores after the first, seventh and tenth and last day of performing the home test. The first day of testing showed the lowest scores. On the last day of testing IBDoc® was awarded the highest grade (B) of all home tests, mainly because the smartphone application was error-friendly and therefore less cumbersome to use. CalproSmart and QuantOnCal had significantly higher reading error rates (RER) than IBDoc®, respectively 5.8% and 4.8%, versus 1.9%.  They argued that any shift of calprotectin values out of the target range (false positive), and into the action range (> 500 μg/g) is a trigger to change the treatment plan. In order to appreciate the true value of the home tests in the high range, they also evaluated the concordance with the respective companion ELISAs and observed that 119 of 125 IBDoc® readings <500 μg/g were concordant with fCAL results (95%), compared to 35% and 49% for the QuantOnCal—IDKCalprotectin and CalproSmart—Calprotectin-ALP pairs.

They concluded that all three calprotectin home tests and companion ELISAs agreed sufficiently when concentrations are <500 μg/g. To minimize wrongful interpretation of calprotectin changes over time it is essential to always use the home test and companion ELISA of one and the same manufacturer. Manufacturers should explicitly evaluate and report the suitability of commonly used smartphones for quantitative calprotectin readings.

In a second poster Dr. Russell Walmsley (video below) showed that the care for patient in a remote care setting was not inferior to conventional care. They randomly assigned 50 IBD (UC and CD) patients to be followed for 52 weeks either to be followed via standard clinic care with face to face meetings between patients and their physicians and 50 patients to be remotely monitored by a combination of two apps. The first app, IBDSmart allowed the patients to fill in Quality of Life (IBDQ) and clinical symptom assessments questionnaires (SCCAI for Ulcerative Colitis patients and HBI for Crohns patients). The second app was IBDoc® that allowed the patients to perform fecal calprotectin measurements at home. The patients used the two apps every 3 months. 82% completed more than 50 % of the required questionnaires and 72 % completed more than 50% of the IBDoc® tests. 58 % of the patients felt comfortable using the apps to replace conventional face to face meetings with their physicians. 78 % of the gastroenterologist were very or somewhat comfortable using the apps and 58 % felt that the apps could adequately replace the face to face appointments with their patients. However, 54 % of the physicians reported that there was something that they could not communicating to the patient using the app alone. For face to face meetings only 10 % of the physicians felt that there was something they could not communicate to the patients.

Overall the authors conclude that the use of IBDSmart and IBDoc® in routine clinical care of IBD patients over 12 months is demonstrated to be acceptable, usable and non-inferior to standard clinic-based care.

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