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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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Three new studies using IBDoc®

Fecal calprotectin (fCAL) is a biomarker used for disease monitoring in patients suffering from intestinal bowel disease (IBD) since it correlates closely with mucosal healing. Calprotectin measuring requires patients to collect and return stool samples resulting in relatively low return rate of samples. Home-based fCAL testing may improve adherence. In this post three recent publications from studies using the BÜHLMANN fCAL home-test IBDoc® are summarized. The publications range from usability studies, correlation to established laboratory methods to correlation to clinical performance:

 

Walsh et al.:

Background: The aim of this study was to correlate fCAL measured using IBDoc® with validated endoscopic and histological disease activity indices in UC.

Methods: Sixty-six patients diagnosed with UC were recruited, and data about various indices such as symptoms (Simple Colitis Clinical Activity Index, SCCAI), quality of life, endoscopic (Ulcerative Colitis Endoscopic Index of Severity, UCEIS) and histological activity (Nancy index) were collected over 6 months. Symptoms were reported daily, quality of life fortnightly, outcomes every 3 months, and endoscopy as well as biopsy at time point 0 and after 6 months. Indices were evaluated and compared to each other.

Results: There was a strong correlation between fCAL and endoscopy and an even stronger correlation between fCAL and histology. It was shown that fCAL levels <187 µg/g were not associated with active endoscopic disease with an area under the curve of 0.915. Further, FC levels < 72 µg/g were not associated with histological inflammation in UC patients with an area under the curve of 0.824.

Conclusion: For measuring disease activity of UC, as well as for endoscopic or histological remission, fCAL is a useful surrogate marker with a strong correlation of R=0.88 between IBDoc® fCAL values and histological score.

  • “This is the first prospective study to use validated endoscopic and histologic indices to determine the thresholds of fCAL that have the greatest sensitivity for detecting active disease.”
  • “An fCAL level <187 µg/g is not associated with active endoscopic disease (UCEIS ≥4) and an FC value <72 ≤g/g is not associated with histological inflammation (Nancy ≥2).”
  • “Using these thresholds in clinical practice may help to avoid endoscopic procedures for those patients not having active endoscopic disease (FC levels <187 µg/g).”

 

Moore et al.:

Background: The aim of the study was to evaluate the usability of the home-based fCAL test IBDoc® and to compare the results generated by IBD patients to a lab-based ELISA fCAL test.

Methods: Patients suffering from CD or UC were prospectively recruited from three tertiary sites across Canada. Thereby, patients performed fCAL measuring using IBDoc® and completed a questionnaire to report the ease-of-use of the home-based fCAL testing. In addition, the BÜHLMANN fCAL® ELISA was performed using the same stool sample in order to compare home-based to laboratory-based fCAL testing.

Results: Sixty-one patients (29 CD, 32 UC), with 19 of them (25%) having active disease, were enrolled in this study. Seventy-nine percent (48 of 61) of participants agreed that the IBDoc® was easy to use and eighty-five percent (52 of 61) of the patients were willing to to use the home-based fCAL test in the future. Comparing IBDoc® results with a laboratory-based ELISA showed an 89% agreement across all values without any false positives or negatives.

Conclusion: Patients suffering from IBD found the IBDoc® fCAL home-test user friendly and results correlated well with the standard laboratory-based ELISA. Therefore, IBDoc® could enable clinicians to adopt a treat-to-target approach more easily and improve patient’s quality of life.

  • This study showed a good correlation between the fCAL measurements from the IBDoc® and the ELISA method, with no false positives or negatives”
  • “The home-based fCAL monitoring kit IBDoc® is acceptable to patients to use”
  • “IBDoc® enable clinicians to more easily adopt a treat-to-target approach, improve long-term outcomes and patients quality of life with IBD”

 

Wei et al.:

Background: The aim of this study was to evaluate the performance of IBD patients using the fCAL home test IBDoc® by comparing the results with the traditional laboratory-based Quantum Blue® fCAL. Experiences and feedback from patients using IBDoc® were observed trough questionnaires.

Methods: IBD patients in clinical remission willing to perform the IBDoc® were enrolled prospectively. Fecal calprotectin was determined by the patients itself using IBDoc® and by a laboratory based test, both using the same fecal sample. In addition, patients filled in a questionnaire about the ease of use of IBDoc®.

Results: Fifty-one patients were enrolled in this study with 27 of them diagnosed with UC, 23 with CD and one with indeterminate IBD. After use, a majority of the patients (65%) found IBDoc® easy to perform and 80% indicated a strong probability to use it for future monitoring when having an acceptable price. Only two patients (4%) felt that IBDoc® was difficult to manage. Seventy percent of the IBD patients preferred to monitor their disease activity with the home-test rather than sending them to the laboratory or perform endoscopy. The correlation between IBDoc® and laboratory-based test results was very good.

Conclusion: The correlation between calprotectin results observed with the IBDoc® and the Quantum Blue® fCAL was very good. Most patients preferred the home test over the laboratory test and endoscopy, since it was easy to perform. This enables IBDoc® to get used as an objective patient-reported outcome tool for IBD patients.

  • “96% of the patients were satisfied with the home test”
  • “Most patients found the home test to be feasible and easy to use and preferred it over laboratory test and endoscopy for monitoring”
  • “The correlation between home fCAL test, which is handled by the patients themselves, and the laboratory test, which is performed by trained staff was very good”

 

References:

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Introducing Patient Home Tests for Calprotectin in a Routine District General Hospital

Read a recent interview with Lead Inflammatory Bowel Disease Nurse, Pearl Avery, conducted by BÜHLMANN’s UK distributor Alpha Laboratories

Highlight the Article:

“In the six months that we have been working with the IBDoc®, one patient was saved from hospital admission. It looked like they were having an IBD flare but the symptoms were actually being driven by something else.

With another patient whose calprotectin results were >1000µg/g we were able to put them on the right treatment (steroids) quickly enough to stop the progress of the disease…”

 

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IBDoc – SwissMedtech Award Nominee

At this year’s SwissMedtech Day, BÜHLMANN was nominated to receive the Swiss Medtech Award. Switzerland is listed by key rankings as the “globally most innovative country”. Medtech one of the industries heavily contributing to this ranking. Out of 25 applications BÜHLMANN Laboratories AG was chosen to present IBDoc® to a Jury of medtech and academic reperesentatives. The jury nominated 3 projects for the Swiss Medtech Award 2018, BÜHLMANN Laboratories AG among them. June 12th IBDoc® was presented to 600 attendees from the entire Swiss Medtech sector. Follow this link to read more about the final nominees and click here to read the IBDoc® publication.

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First IBD Nurse led IBDoc Study

Pearl Avery, UK IBD Nurse of the year, shares her first experience using IBDoc® in clinical practice. She explains the study she published at ECCO 2018 in Vienna in this video:

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IBDoc is now part of the TactioRPM

Tactio Health Group and Telia Company team up to accelerate the development of patient-centred digital health programs in Sweden and other Nordic and Baltic countries.

The Swedish telecommunication company Telia, together with AbbVie Sweden, developed the IBD Home platform using the  TactioRPM platform. IBD Home is a complete IBD remote monitoring ecosystem. The IBD Home app allows patients to fill in symptom scores and other important information on their smartphone. Using a seamless integration the Swedish patients an simply press the “Calprotectin” button and are automatically logged into the IBDoc® App, perform their calprotectin home test, and the result is shared from IBDoc® to the IBD Home app in the background. All data is then available to the gastroenterologists and also fed into the Swedish IBD registry, SWIBREG.

Read the full Press Release form Tactio Health Group here.

Watch these Videos (in Swedish) to get an overview of the system:

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CALPROTECTIN TESTING GOES MOBILE

Read a recent post from Amanda Appleton, the Product Manager for Calprotectin at our UK distributor Alpha Laboratories. She ends the article with following sentence:

“App technology has the ability not only to improve the health of patients but to save money through rapid optimisation of treatment, enable early interventions through monitoring before conditions get too serious and reduce routine check-up appointments/procedures, freeing up limited resource in both pathology and the clinic.”

Read the full article here.

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