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Comparative acceptability and perceived clinical utility of monitoring tools: A nationwide survey of patients with inflammatory bowel disease

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Comparative Acceptability and Perceived Clinical Utility of

Monitoring Tools: A Nationwide Survey of Patients with

In

flammatory Bowel Disease

Anthony Buisson, MD, PhD,

1,2

Florent Gonzalez, MD,

3

Florian Poullenot, MD,

4

Stéphane Nancey, MD, PhD,

5

Elisa Sollellis, MD,

1

Mathurin Fumery, MD,

6

Benjamin Pariente, MD, PhD,

7

Mathurin Flamant, MD,

8

Caroline Trang-Poisson, MD,

9

Guillaume Bonnaud, MD,

10

Stéphane Mathieu, MD,

11

Alain Thevenin, MD,

12

Marc Duruy, MD,

13

Jérôme Filippi, MD,

14

Franc¸ois L

’hopital, MD,

15

Fabrice Luneau, MD,

16

Véronique Michalet, MD,

15

Julien Genès, MD,

15

Anca Achim, MD,

17

Emmanuelle Cruzille, MD,

15

Gilles Bommelaer, MD, PhD,

1,2

David Laharie, MD, PhD,

4

Laurent Peyrin-Biroulet, MD, PhD,

18

Bruno Pereira, PhD,

19

Maria Nachury, MD,

7

and Guillaume Bouguen, MD, PhD,

20

for the ACCEPT study group

Background:Objective control of intestinal inflammation during inflammatory bowel disease (IBD) is becoming the main driver for medical treatment. However, the monitoring tools-related burden remains poorly investigated. We aimed to evaluate their comparative acceptability and utility according to patients with IBD.

Methods: After a preliminary phase, thefinal questionnaire encompassing self-administered and physician questionnaires was prospectively and consecutively submitted to 916 patients with IBD from 20 public and private centers. Acceptability and utility visual analog scales (VAS) were expressed as median with interquartile range.

Results: Regarding the group of patients with Crohn’s disease (n ¼ 618), venipuncture (VAS ¼ 9.3 [8.8–9.7]) and ultrasonography (VAS ¼ 9.3

[8.7–9.7]) were the most acceptable tools (P , 0.0001, for each comparison), whereas rectosigmoidoscopy was the least acceptable tool (VAS ¼ 4.4

[1.2–7.3]) (P , 0.0001, for each comparison). Wireless capsule endoscopy (VAS ¼ 8.5 [5.2–9.3]), magnetic resonance enterocolonography (VAS ¼ 8.0

[5.0–9.2]), and stools collection (VAS ¼ 7.7 [4.6–9.3]) were more acceptable than colonoscopy (VAS ¼ 6.7 [4.3–8.9]) (P , 0.0001, for each

comparison). The acceptability was assessed in 298 patients with ulcerative colitis for venipuncture (VAS ¼ 9.4 [8.8–9.7]), stools collection

(VAS¼ 8.1 [5.7–9.4]), colonoscopy (VAS ¼ 7.5 [4.7–9.2]), and rectosigmoidoscopy (VAS ¼ 6.7 [2.8–9.1]); (P , 0.001 for each comparison). All

monitoring tools were considered as highly useful by patients with IBD. Decreased acceptability was related to embarrassment for the collection/transport of stools (60.7%), bowel cleansing (76.3%) for colonoscopy, abdominal discomfort (51.3%) and rectal enema (36.6%) for rectosigmoidoscopy, bowel distension (48.3%) for magnetic resonance enterocolonography, and potential capsule retention (21.4%) for wireless capsule endoscopy.

Conclusions:Among the IBD monitoring tools, endoscopy demonstrated the lowest acceptability supporting the development of alternative modalities.

Patients’ information and examination conditions should be improved to ensure proper monitoring adherence.

(Inflamm Bowel Dis 2017;23:1425–1433)

Key Words: inflammatory bowel disease, acceptability, utility, monitoring tools, colonoscopy

Received for publication March 3, 2017; Accepted March 29, 2017.

From the 1Université Clermont Auvergne, Inserm, 3iHP, CHU Clermont-Ferrand, Service d’Hépato-Gastro Entérologie, Clermont-Ferrand, France; 2Université Clermont Auvergne, Inserm U1071, M2iSH, USC-INRA 2018, F-63000 Clermont-Ferrand, France;3Gastroenterology Department, Private Practice, Nimes, France;4Gastroenterology

Department, University Hospital, Bordeaux, France;5Hospices Civils de Lyon, Lyon-Sud Hospital, Gastroenterology, Pierre Benite, France;6Gastroenterology Department, University Hospital, Amiens, France;7Gastroenterology Department, University Hospital, Lille, France;8Gastroenterology Department, Private Practice, Nantes, France;9Gastroenterology

Department, University Hospital, Nantes, France;10Gastroenterology Department, Private Practice, Cornebarrieu, France;11Gastroenterology Department, Private Practice, Clermont-Ferrand, France;12Gastroenterology Department, Private Practice, St Quentin, France;13Gastroenterology Department, Private Practice, Arles, France;14Department of

Gastroenter-ology, Archet 2 University Hospital, Nice, France;15Gastroenterology Department, Private Practice, Riom, France;16Gastroenterology Department, Private Practice, Chateauroux, France;17Gastroenterology Department, Private Practice, Beaumont, France;18Department of Gastroenterology, CHU Nancy Brabois, Vandoeuvre les Nancy, France;19Biostatistics

Unit, GM—Clermont-Ferrand University and Medical Center, Clermont-Ferrand, France; and20Gastroenterology Department, University Hospital, Rennes, France.

The authors have no conflict of interest to disclose.

All authors approved thefinal version of the article, including the authorship list.

Address correspondence to: Anthony Buisson, MD, PhD, University Hospital Estaing, Gastroenterology Department, 1 Place Aubrac, 63100 Clermont-Ferrand, France (e-mail: a_buisson@hotmail.fr).

Copyright © 2017 Crohn’s & Colitis Foundation DOI 10.1097/MIB.0000000000001140 Published online 24 May 2017.

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I

nflammatory bowel diseases (IBDs), encompassing Crohn’sdisease (CD) and ulcerative colitis (UC), are chronic disabling disorders that can alter quality of life.1,2Mucosal healing is

rec-ognized hitherto as the best therapeutic endpoint in IBD, as it was associated with sustained clinical remission, reduced rates of hos-pitalization, and decreased risk of surgery.3–8Repeated colonos-copies are consequently warranted to tightly monitor mucosal inflammation and to adapt the therapeutic strategy.9–11Because

of the burden induced by the repeat of such an examination for the patients, including the risk of potential complications (especially perforations),11alternative tools have been developed in the last

decade for the monitoring of IBD.

Flexible rectosigmoidoscopy is highly correlated with colonoscopy for UC activity assessment and is often preferred to avoid general anesthesia.12 C-reactive protein dosage is the

most used serological biomarker. Although the absolute value of C-reactive protein could be normal even in the presence of ulceration,13 C-reactive protein normalization is associated with

favorable clinical outcomes in patients treated with biologics.14,15

The measurement of inflammatory proteins in the stools is an attractive option. Fecal calprotectin is considered as the most effective fecal biomarker to detect endoscopic activity in IBD.16–31 In the last decade, some authors reported that fecal calprotectin was correlated with endoscopic scores and was able to detect endoscopic ulceration in IBD.30–33Cross-sectional imag-ing is another alternative option to monitor patients with CD. In this context, magnetic resonance enterocolonography (MRE), per-formed with no enteroclysis, no bowel cleansing the day before the examination and no rectal enema, demonstrated high accuracy in CD and is preferred to CT because of its lack of ionizing radiations.34–38Bowel ultrasonography is another tool for evalu-ation of CD activity in terms of complicevalu-ations, postoperative recurrence, and monitoring response to medical therapy.39

Finally, wireless capsule endoscopy (WCE) is an accurate tool to diagnose CD involving the small bowel and to assess inflam-matory activity.40–42 All these monitoring tools are considered as minimally invasive by IBD physicians but their real discomfort according to the patients’ feeling remains poorly investigated.

This study aimed to compare the acceptability and the perceived clinical utility of these monitoring tools according to IBD patients’ opinion.

MATERIALS AND METHODS

Ethical Considerations

The study was performed in accordance with the Declara-tion of Helsinki, Good Clinical Practice and applicable regulatory requirements. The study was approved by the local Ethics Committee (IRB#00008526ref2015/CE66).

Questionnaires and Patients

Afirst version of the questionnaire was developed by the scientific committee of the ACCEPT study (A.B., F.G., and G.B.).

This first version was then submitted to an external reviewer (L.P.-B.) leading to minor corrections. The preliminary phase, including 20 patients, was performed in the University Hospital Estaing of Clermont-Ferrand, France, to confirm the feasibility of the questionnaire. After this preliminary phase, the final ques-tionnaire was composed of 2 parts: a self-administered question-naire and a physician questionquestion-naire filled out independently. In thefirst part, the patient indicated demographics and evaluated the acceptability and the perceived utility of each monitoring tool using visual analog scales (VAS). We decided to use VAS as no other tool has been validated in this indication. VAS ranged from 0 (absolutely unacceptable or useless) to 10 (totally acceptable or useful). VAS was requested for venipuncture, stools collection, colonoscopy, rectosigmoidoscopy, MRE, ultrasonography, and WCE for patients with CD, whereas VAS was collected only for venipuncture, stools collection, colonoscopy, and rectosigmoido-scopy for patients with UC. The patients were asked to evaluate acceptability and utility using VAS, only for the examinations that they have previously undergone. In addition, the patients were questioned about the factors that decreased the acceptability of each monitoring tool. The second part (filled out by the physician) collected patients’ demographics, Montreal classification,43

con-comitant therapies for IBD, and clinical score (Harvey Bradshaw Index for CD and Simple Clinical Colitis Activity Index for UC).44Active disease was defined by a Harvey Bradshaw Index

above 4 for CD and a Simple Clinical Colitis Activity Index above 2 for UC.

Patients with an established diagnosis of IBD for at least 3 months have been prospectively and consecutively included during 6 weeks (between June 1, 2015, and July 14, 2015). This study took place in 20 French centers encompassing 9 university hospitals and 11 private centers.

Statistical Analysis

Statistical analyses were performed using Stata software, version 13 (StataCorp, College Station, TX). The tests were 2-sided, witha ¼ 0.05. Patient’s characteristics were described as mean6 SD or median and interquartile range (IQR) for contin-uous variables, according to statistical distribution (normality as-sessed using the Shapiro–Wilk test), and as the number of patients (%) for categorical variables. VAS were expressed as median with IQR. Comparisons between independent groups were performed using Chi-squared or Fisher’s exact tests for categorical variables and analysis of variance or Kruskal–Wallis tests if assumptions of analysis of variance are not met ([1] normality and [2] homo-scedasticity studied using the Bartlett’s test) for quantitative pa-rameters. When appropriate, a suitable post hoc test was applied for multiple comparisons: Tukey–Kramer after analysis of vari-ance or Dunn test after Kruskal–Wallis. Then, a regression linear model for continuous dependent variable was performed in mul-tivariate situation using backward and forward stepwise regres-sion on the factors considered significant in univariate analysis. The normality of residuals was studied as described previously. When appropriate, a logarithmic transformation of dependent

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outcome has been proposed. Finally, in paired context (compar-isons as utility versus acceptability), paired t test or Wilcoxon test was used for quantitative variables and Stuart–Maxwell for cat-egorical parameters.

RESULTS

Characteristics of the Patients

Of the 923 collected questionnaires, 916 were suitable for the analysis. Patients’ characteristics are given in Table 1. Overall, our cohort included 618 patients with CD. Among them, 36.6% were male and 34.0% had undergone a previous CD-related sur-gery. The mean disease duration was 12.06 13.0 years. Among the 298 patients with UC included in our cohort, 48.5% were male, and the mean disease duration was 14.7 6 21.9 years. According to the clinical scores, 34.2% and 39.5% of the patients experienced active disease at the time of the study in CD and UC, respectively.

Acceptability of Monitoring Tools in the

Overall IBD Population

Patients with CD

Considering patients with CD, the distribution and the median of acceptability VAS for each monitoring tool are presented in Figure 1. For the patients with CD, venipuncture (VAS ¼ 9.3 IQR [8.8–9.7]) and ultrasonography (VAS ¼ 9.3 IQR [8.7–9.7]) were the most acceptable tools (P , 0.0001, for each comparison), whereas rectosigmoidoscopy was the least acceptable tool (VAS¼ 4.4 IQR [1.2–7.3]) (P , 0.0001, for each comparison) (Fig. 2A). WCE (VAS¼ 8.5 IQR [5.2–9.3]), MRE (VAS¼ 8.0 IQR [5.0–9.2]), and stools collection (VAS ¼ 7.7 IQR [4.6–9.3]) were significantly more acceptable than colono-scopy (VAS¼ 6.7 IQR [4.3–8.9]) (P , 0.0001, for each com-parison) (Fig. 2A). Although WCE (VAS¼ 8.5 IQR [5.2–9.3]) was more acceptable than stools collection (VAS ¼ 7.7 IQR [4.6–9.3]) (P ¼ 0.047), we did not observe statistically significant difference between the acceptability of MRE (VAS ¼ 8.0 IQR

TABLE 1. Characteristics of the 916 Patients with IBD

Included in the Study

Patients with

CD (n¼ 618)

Patients with

UC (n¼ 298)

Age, mean6 SD 38.26 20.1 yr 42.16 14.5 yr

Disease duration, mean6 SD 12.06 13.0 yr 14.76 21.9 yr

Male sex, n (%) 222/607 (36.6) 142/293 (48.5)

Previous intestinal resection, n (%)

210 (34.0) —

Montreal classification,

n (%) Age at diagnosis, n (%) A1 98/605 (16.2) — A2 441/605 (72.9) — A3 66/605 (10.9) — Location, n (%) L1 168/588 (28.6) — L2 95/588 (16.2) — L3 325/588 (55.3) — L4 26/618 (4.2) — Behavior, n (%) B1 244/521 (46.8) — B2 193/521 (37.0) — B3 84/521 (16.1) — Perineal lesions, n (%) 207/584 (35.4) — Extension, n (%) E1 — 47/288 (16.3) E2 — 121/288 (42.0) E3 — 120/288 (41.7)

Clinical active disease, n (%)

HBI$4 208/608 (34.2) —

SCCAI.2 — 115/291 (39.5)

Clinical active disease

according to the patients’

judgments, n (%)

132/598 (22.1) 67/290 (23.1)

Public practice, n (%) 521/618 (84.3) 216/296 (72.5)

Private practice, n (%) 97/618 (15.7) 82/298 (27.5)

No. of patients experiencing monitoring tools

Venipuncture 618 298

Stools collection 520 255

Colonoscopy 618 283

Rectosigmoidoscopy 227 248

Magnetic resonance imaging 461 —

Ultrasonography 494 —

WCE 93 —

Distance to medical center, mean

6 SD, km 53.36 67.6 51.76 55.1 Education level, n (%)

TABLE 1. (Continued)

Patients with CD (n¼ 618) Patients with UC (n¼ 298)

Discontinuation before the baccalaureate 183/588 (31.1) 84/282 (29.8) Baccalaureate 164/588 (27.8) 83/282 (29.4) License 147/588 (25.0) 66/282 (23.4) Master 82/588 (14.0) 45/282 (16.0) Doctorate 12/588 (2.1) 4/282 (1.4)

HBI, Harvey–Bradshaw Index; SCCAI, Simple Clinical Colitis Activity Index.

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FIGURE 1. Distribution of analog visual scales reflecting the acceptability and the utility from the patient’s point of view for each CD monitoring

tool i.e. venipuncture (n¼ 618) (A), stools collection (n ¼ 520) (B), colonoscopy (n ¼ 618) (C), rectosigmoidoscopy (n ¼ 227) (D), magnetic

resonance enterography (n¼ 461) (E), ultrasonography (n ¼ 494) (F), and WCE (n ¼ 93) (G). VAS are expressed in median and the concordance

coefficients were calculated between acceptability and utility. *indicates significant concordance.

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[5.0–9.2]) and WCE (VAS ¼ 8.5 IQR [5.2–9.3]) (P ¼ 0.36) or between MRE (VAS¼ 8.0 IQR [5.0–9.2]) and stools collection (VAS¼ 7.7 IQR [4.6–9.3]) (P ¼ 0.65) (Fig. 2A).

Patients with UC

The distribution and the median VAS of acceptability for each monitoring tool are presented in Figure 3. The most acceptable monitoring tools for patients with UC are in the descending order: venipuncture (VAS¼ 9.4 IQR [8.8–9.7]), stools collection (VAS ¼ 8.1 IQR [5.7–9.4]), colonoscopy (VAS ¼ 7.5 IQR [4.7–9.2]), and rectosigmoidoscopy (VAS ¼ 6.7 IQR [2.8–9.1]). Although rectosigmoidoscopy was one of the most used examination tool in the monitoring of UC in our cohort (248 patients out of 298), its acceptability was the worst (P , 0.001 for each comparison between rectosigmoidoscopy and other tools) (Fig. 4A).

Factors Associated with Acceptability

From the first part of the questionnaire filled out by the patients, the main factors leading to decrease the acceptability for each monitoring tool were retrieved (Table 2). The pain (22.2%) and the risk of complications such as ecchymosis and infection (16.5%) are the main factors decreasing the acceptability of veni-puncture. Stools collection acceptability was impacted by the embarrassment to collect the stools (43.0%), the dirtiness feeling (23.0%), and the problem of transporting the sample (17.7%). The major drawbacks for colonoscopy were bowel cleansing (76.3%) and risk of complications, especially perforation (20.6%). Dis-comfort (bloating and pain) (51.3%), embarrassment to undergo the examination (31.3%), and the need for rectal enema (36.6%) were described as negative factors for rectosigmoidoscopy. Acceptability for performing MRE was decreased by the use of polyethylene glycol ingestion to achieve bowel distension (48.3%) leading to potential diarrhea (35.0%) or vomiting (33.7%) and the need for peripheral vein installation and gadoli-nium injection (14.0%). No factor was notified by the patients as limiting the acceptability of ultrasonography. The main factors decreasing WCE acceptability were the risk of capsule retention

(21.4%), the need for bowel cleansing (20.0%), and the difficulty to swallow the capsule (15.5%).

We investigated the factors associated with decrease acceptability of each monitoring tool in univariate and multivar-iate analyses. The factors assocmultivar-iated with lower VAS values are detailed in Table 2. The 3 independent factors associated with a decreased acceptability of colonoscopy were female sex, young age at diagnosis, and education level higher than baccalaureate. Female sex, long period elapsed since undergoing the examina-tion, patients with CD, and active disease were associated with decreased acceptability of rectosigmoidoscopy. Female sex had also a negative impact on acceptability of WCE, ultrasonography, and stools collection. Finally, ultrasonography was more accept-able for patients with private practice monitoring.

Perceived Clinical Utility of Monitoring Tools

in the Overall IBD Population

Patients with CD

The distribution and the median of utility VAS for each monitoring tool are presented in Figure 1. Venipuncture (VAS¼ 9.4 IQR [8.9–9.8]) and colonoscopy (VAS ¼ 9.0 IQR [7.8–9.5]) (P, 0.0001 for each comparison) were considered as the most useful tools by patients with CD, whereas rectosigmoidoscopy was considered as the least useful one (VAS ¼ 6.5 IQR [4.1–9.1]). We observed similar utility for MRE (VAS ¼ 8.8 IQR [7.4–9.4]), stools collection (VAS ¼ 8.6 IQR [6.3–9.4]), ultrasonography (VAS¼ 8.8 IQR [6.9–9.5]), and WCE (VAS ¼ 8.7 IQR [5.5–9.4]) (Fig. 2B).

UC

The distribution and the median of utility VAS for each monitoring tool are presented in Figure 1. All the monitoring tools, i.e., venipuncture, stools collections, colonoscopy, and rec-tosigmoidoscopy, demonstrated similar utility for the patients with VAS of 9.3 IQR (8.8–9.7), 9.0 IQR (7.1–9.6), 9.2 IQR (8.0–9.6), and 8.9 IQR (7.0–9.5), respectively (Fig. 4B).

FIGURE 2. Comparison between acceptability (A) and utility (B) visual analog scores (median) for the different CD monitoring tools.

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Concordance Between Acceptability and

Perceived Clinical Utility in Patients with IBD

Considering the overall patients with IBD, we observed moderate or substantial concordance between acceptability and perceived clinical utility in IBD patients with coefficient ranging from 0.55 to 0.76 (Figs. 1 and 3), whereas colonoscopy demon-strated the lowest concordance (from 0.46 to 0.51) (Figs. 1 and 3).

DISCUSSION

To our knowledge, this study is the first to investigate acceptability and perceived utility of the monitoring tools in a large nationwide cohort of 923 patients with IBD. Many researches are currently focusing on the development of minimally invasive technics to follow patients with IBD aiming to reduce the burden experienced by the patients. However, the opinions differ between patients and physicians to define the noninvasive nature of each tool.

For patients with IBD, endoscopy was the least appreciated procedure. Among them,flexible rectosigmoidoscopy is by far the least accepted. In clinical practice, IBD physicians performed rectosigmoidoscopy rather than colonoscopy to monitor patients with UC because of its accessibility, rapidity, and the absence of anesthesia. In addition, a high agreement between rectosigmoido-scopy and colonorectosigmoido-scopy has been recently shown for disease activity assessment and mucosal healing in patients with UC.12By contrast,

patients with IBD would choose colonoscopy rather than rectosig-moidoscopy. For most patients (82.8%), the need for general anes-thesia was not a drawback, whereas abdominal discomfort (51.3%) and embarrassment (31.3%) represented majors concerns for flex-ible rectosigmoidoscopy. More than one-third of the patients dis-agreed with the use of rectal enema before rectosigmoidoscopy with the feeling of unclear utility especially for patients experienc-ingflares. As expected, bowel cleansing had a negative impact on colonoscopy acceptability (76.3% of the patients), and efforts have to be done to replace historical bowel cleansing.

FIGURE 3. Distribution of VAS reflecting the acceptability and the utility from the patient’s point of view for each UC monitoring tool i.e.,

venipuncture (n¼ 298) (A), stools collection (n ¼ 255) (B), colonoscopy (n ¼ 283) (C), and rectosigmoidoscopy (n ¼ 248) (D). VAS are expressed in

median, and the concordance coefficients were calculated between acceptability and utility. *indicates significant concordance.

FIGURE 4. Comparison between acceptability (A) and utility (B) visual analog scores (median) for the different UC monitoring tools.

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In our cohort, patients with CD considered MRE as significantly more acceptable than colonoscopy. It was in line with a previous study including 31 patients with CD comparing these 2 modalities.45The authors reported that most of the patients

(29/31) prefer MRE for the next examination. They observed that bowel distension used for MRE was significantly less burdensome than bowel cleansing for colonoscopy.45In another small sample

size study, a majority of the 18 patients, including 10 patients with IBD, preferred MRE performed with rectal enema (1.5 L of water) to colonoscopy.46 Although some teams proposed to maintain

bowel cleansing the day before MRE and rectal enema during the examination,35,36it has been clearly shown that it is not

war-ranted. Performing MRE with no bowel cleansing and no rectal enema does not alter the MRE performances in evaluating

TABLE 2. Factors Leading to Decreased Acceptability According to the 916 IBD Patients

’ Judgments and Factors

Associated with Decreased Acceptability Retrieved from Multivariate Analysis

Monitoring Tools

Main Factors Leading to Decreased Acceptability

According to the 916 IBD Patients’ Judgments

(Only Factors Reaching 10% of Vote Were Given) %

Factors Associated to Decreased Acceptability VAS in Multivariate Analysis

Venipuncture None 45.6 Young age at diagnosis (A1)

Pain 22.2

Risk of complications (infection, ecchymosis.) 16.5

The need to go to the laboratory 14.6

Concern about the results 13.8

Fear of needles 10.3

Stools collection None 34.5 Female sex

Embarrassment to collect the stools 43.0 Long period elapsed since undergoing the examination

Dirtiness feeling 23.0

The problem to transport the sample 17.7

The need to go to the laboratory 15.2

Concern about the results 11.2

Colonoscopy None 10.5 Female sex

Bowel cleansing 76.3 Education level higher than baccalaureate

Type of bowel cleansing 45.3 Young age at diagnosis (A1)

Risk of complications (perforations.) 20.6

Concern about the results 18.3

General anaesthesia 17.2

Rectosigmoidoscopy None 18.5 Female sex

Discomfort (bloating, pain.) 51.3 Long period elapsed since undergoing the examination

Rectal enema 36.6 Active disease

Embarrassment to undergo the examination 31.3 CD

Concern about the results 14.6

Risk of complications (perforations.) 11.7

MRI None 23.6 None

PEG ingestion to achieve bowel distension 48.3

PEG-induced diarrhea 35.0

Vomiting 33.7

Gadolinium intravenous injection 14.0

Concern about the results 12.3

Ultrasonography None 70.0 Female sex

Public practice

WCE None 35.8 Female sex

Risk of capsule retention 21.4

Bowel cleansing 20.0

The difficulty to swallow the capsule 15.5

MRI, magnetic resonance imaging; PEG, polyethylene glycol.

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inflammatory activity or detecting endoscopic ulcerations37,38,47

and highly improves its acceptability.48Further research is needed

to find alternative modalities of polyethylene glycol for bowel distension as suggested by this cohort. Ultrasonography is the most acceptable examination to assess small bowel inflammation in CD. Unfortunately, the operator-dependent characteristics and the difficulties to explore the overall bowel length are known limiting factors of ultrasound. Novel modalities of ultrasonogra-phy could counterbalance these weaknesses in the near future. The strong acceptability of ultrasound encourages the develop-ment of future research to assess the value of ultrasound for IBD monitoring.

WCE and MRE were well-accepted tools for patients with CD. In addition, WCE did not demonstrate a significant higher acceptability than MRE. In a previous study including 38 patients with known or suspected CD, WCE was significantly favored over MRE with enteroclysis with respect to bowel preparation and swallowing of the capsule (compared with insertion of the tube/scope).49 The use of enteroclysis could

partly explain thesefindings. However, Lahat et al50compared

patients’ tolerance and preference to MRE with no enteroclysis versus WCE in 56 patients with CD. Before examination dis-comfort, during-examination disdis-comfort, nausea, vomiting, bloating, and abdominal pain were all significantly more prom-inent in MRE as compared to WCE.50Seventy-eight percentage

of patients (44 patients) preferred to repeat CE as compared to 22% (P ¼ 0.0001) who preferred MRE.50 Once again, this

underlines the detrimental impact of the use of polyethylene glycol or mannitol for bowel distension before MRE. WCE should be more widely used in daily practice regarding its well acceptability and its reliability.

Although stools collection was more acceptable than endoscopic procedures, it was surprisingly less acceptable than MRE or WCE for patients with CD. Stools collection acceptabil-ity was impacted by the embarrassment to collect the stools (43.0%), the dirtiness feeling (23.0%), and the problem to transport the sample (17.7%). Investigations should be led to facilitate samples collection and transportation, as it was done for fecal immunochemical test during colorectal cancer screening. Venipuncture was overall the most acceptable examination. Unfortunately, serum biomarkers are mainly not gut specific and are considered as adjunctive tools.51

Patients with IBD considered that all IBD monitoring tools are very useful except rectosigmoidoscopy for patients with CD. It probably reflects the very strong confidence relationship between patients with IBD and their physicians.

Several strengths have to be underlined in this study. It was the largest cohort reported hitherto (916 patients and 20 centers sharing referral centers and private practice) which compare all the IBD monitoring modalities in the same cohort. In addition, the questionnaire was developed using a reliable methodology.

In conclusion, serum or fecal biomarkers, WCE, MRE and ultrasonography have been identified by patients with IBD as

more acceptable modalities than endoscopic procedures. The identification using a rigorous scientific approach of the strengths and the perceived weaknesses of such examinations should lead to an improvement in the acceptability of these monitoring tools. This study was an essential step to improve the information delivered to the patients, to optimize follow-up adherence of the patients, and to maximize the use of the current IBD monitoring tools.

ACKNOWLEDGMENTS

We thank the theatrical troupe the so-called“Les femmes de Villosanges,” for contributing to this work.

Collaborators of the ACCEPT study group:

M. Dapoigny, F. Goutorbe, C. Duron, M. Goutte (CHU Estaing Clermont-Ferrand); G. Boschetti, B. Flourié, P. Danion (HCL Lyon-Sud), A. Bourreille (Nantes), J. L. Dupas (Amiens), and X. Hébuterne (Nice).

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Figure

FIGURE 1. Distribution of analog visual scales reflecting the acceptability and the utility from the patient’s point of view for each CD monitoring tool i.e
FIGURE 2. Comparison between acceptability (A) and utility (B) visual analog scores (median) for the different CD monitoring tools.
FIGURE 4. Comparison between acceptability (A) and utility (B) visual analog scores (median) for the different UC monitoring tools.

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