Introduction

The Celiac Disease Symptom Diary Version 2.1 (CDSD v2.1) is a patient-reported outcome (PRO) measure designed to capture the severity of five celiac disease (CeD) symptoms (diarrhea, abdominal pain, bloating, nausea and tiredness) that have been identified as most relevant from the patient perspective.¹ The diary has a 24-hour recall period and symptoms are scored on a 5-point scale ranging from 0 = “none” to 4 = “very severe”. The present analysis aimed to confirm the reliability, validity and responsiveness of CDSD v2.1 average symptom severity scores and percentage of symptom-free days per week (%SFD) scores.

Aims & Methods

This psychometric analysis of the CDSD v2.1 was conducted using data from a double-blind, randomized, placebo-controlled, multicenter, phase 2 clinical study (NCT5353985)² assessing the efficacy and safety of zamaglutenase (TAK-062) in patients with moderate to severe CeD (N = 153). The CDSD v2.1 was electronically administered each evening throughout the study (6–8-week screening period and 24-week treatment period). Average gastrointestinal (GI) symptom severity and %SFD GI domain scores (for diarrhea, abdominal pain, bloating and nausea) were evaluated at 7-day intervals. Test-retest reliability was determined using intraclass correlation coefficients (ICCs). Construct validity was assessed via correlations between the CDSD v2.1 scores and the Gastrointestinal Symptom Rating Scale (GSRS) clusters, and by calculating mean CDSD v2.1 scores across known groups (defined using the Patient Global Impression of Severity [PGIS]). Responsiveness was evaluated by estimating mean CDSD v2.1 change scores by change in the PGIS and Patient Global Impression of Change (PGIC) between baseline and Week 24. Anchor-based methods using the PGIS and PGIC were also used to define meaningful within-patient change thresholds (MWPC). Cumulative distribution function (CDF) curves were generated to support estimation of MWPC.

Results

Test-retest reliability was adequate when measured from Weeks –4 to –2, with ICC values ranging from 0.66 to 0.72 for average GI symptom severity scores and 0.49 to 0.52 for %SFD GI domain scores based on estimates for the overall group and the stable subgroup (i.e., those with no change on the PGIS), respectively. Convergent validity was supported via moderate-to-strong correlations of respective GSRS clusters with average GI symptom severity (0.51–0.75) and %SFD GI domain (0.4–0.44) scores at Week 24. On average, patients who reported more severe symptoms on the PGIS had higher CDSD v2.1 composite scores than those who reported less severe symptoms (p < 0.001). Responsiveness correlations with the PGIS were adequate (> 0.37) and slightly lower with PGIC (0.32–0.37). CDSD v2.1 average GI symptom severity and %SFD GI domain change scores were correctly ordered, in terms of worsening/improvement, by the PGIS change groups and by the PGIC. Anchor levels selected to reflect meaningful improvement were 1-point improved PGIS and “little improved” PGIC. CDF curves at Week 24 were adequately separated among the anchor categories and their respective no-change groups.

Conclusion

The results from this study support the CDSD v2.1 as a reliable, valid and responsive measure and provide psychometric evidence for constructing clinical study endpoints based on change in average GI symptom severity or %SFD GI domain scores in patients with moderate to severe CeD.

References

1. Howard K, et al. Development of the Celiac Disease Symptom Diary version 2.1© (CDSD 2.1©) patient-reported outcome measure. Qual Life Res 2024;33:3275–82. doi: 10.1007/s11136-024-03799-6.
2. ClinicalTrials.gov. A study of TAK-062 in treatment of active celiac disease in participants attempting a gluten-free diet. Available from:https://clinicaltrials.gov/study/NCT05353985 (Accessed April 3, 2025).

Disclosure

SG, MJT, DL and MA are employees and shareholders of Takeda. NR and LM are employees of RTI Health Solutions, which received research funding from Takeda for conducting this study.

Introduction

Aims & Methods

To establish a methodology for accurately estimating the required length of PICC lines.
Between November 2023 and April 2025, various body measurements were collected during PICC line placements. The depth of the selected vein was measured sonographically. Patients’ height, weight, and sex were documented. The PICC line length was determined based on clinical expertise. A post-insertion chest X-ray was performed to confirm the central position of the catheter tip. The distance from the catheter tip to the carina was measured to objectively define central placement. Multiple formulas in clinical use were compared for their accuracy. A regression analysis was conducted to develop a formula that is both accurate and simple to apply.

Results

​A total of 60 PICC lines were successfully inserted without complications. The median patient height was 168 cm (range: 164.3–175.8 cm), weight 59 kg (range: 50.0–83.8 kg), and age 56.5 years (range: 46–65.8). Thirty-five insertions were performed in female patients. The ideal PICC line length was 42 cm (range: 38–44.5 cm). Of the five tested formulas, the best correlations were found with Formula 5 (puncture site to jugulum + jugulum to 3rd intercostal space) with r = 0.68 (p = 0.0005), and Formula 3 (puncture site to acromion + clavicle length + jugulum to 4th intercostal space) with r = 0.67 (p = 0.0005). In simple linear regression, the distances from puncture site to acromion and to jugulum were significantly correlated (p = 0.0007 and p = 0.0019, respectively). The best-fit model in multiple regression included age, height, weight, arm side, puncture site to jugulum, and puncture site to 4th intercostal space (p = 0.0005).

Conclusion

An optimal formula for calculating the correct PICC line length has been identified.

References

Table 1: comparison between the various existing formulas and the newly developed one.

Introduction

Inflammatory bowel disease (IBD) significantly impacts patients’ nutritional status and quality of life. Nutritional deficiencies are common in IBD and can worsen disease progression.

Aims & Methods

The aim of this study is to assess the nutritional status of patients with IBD and explore its relationship with quality of life in this cohort. A cross-sectional study conducted at a specialized center assessed nutritional status using the MUST and MIRT tools. For pediatric patients, the "Strong Kids" screening tool was used. A multidisciplinary nutritional intervention was provided, followed by quality of life evaluation using the EQ-5D and IBDQ-32 instruments. Statistical analyses were performed to examine the association between nutritional status and quality of life.

Results

Among 90 IBD patients, 26.6% required hospitalization due to disease flare-ups, primarily adults and females. The median age was 36.7 years (range: 4–81, SD: 32.6), with 58.3% diagnosed with Crohn’s disease and 83.3% requiring biologic therapy (Table 1). The odds ratios (OR) for malnutrition in hospitalized patients were 8.33 (95% CI: 1.16–27) for ulcerative colitis and 25 (95% CI: 11.6–45.2) for Crohn’s disease. All hospitalized adults exhibited poor biochemical control and moderate-to-severe hypoalbuminemia; 25% had sarcopenia. Nutritional support was provided to 49% of patients within the past year. All severely ill hospitalized patients were malnourished.
Pediatric patients, all of whom received nutritional support, demonstrated a higher degree of nutritional compromise. Among these, 25% required parenteral nutrition, while 87.5% received enteral nutrition, primarily with high-calorie, high-protein formulas. During hospitalization, 87.5% gained weight and improved nutritionally, with 75% achieving normal nutritional status at three-month follow-up, although one patient died.
Following the nutritional intervention, over 80% of adults did not experience further nutritional deterioration. In the outpatient cohort, 20 patients were evaluated, of whom 30% were identified as high risk for malnutrition according to MUST, and 25% had nutritional risk (MIRT score ≥3). Patients with poorer initial nutritional status had significantly worse quality of life, with notable impairments in mobility (P = 0.2778; 95% CI: 2.03–64.1), self-care (P = 0.003; 95% CI: 9.45–90.5), daily activities (P = 0.1457; 95% CI: 1.14–58.2), pain/discomfort (P = 0.197; 95% CI: 0.53–53.3), and visual analog scale scores (P = 0.012; 95% CI: 22.9–88.4). Poor nutritional status was also associated with lower quality of life scores on the IBDQ-32 (P = 0.04; 95% CI: 10.3–60.7).

Conclusion

Nutritional status is a key component of IBD management, as malnutrition is linked to poorer quality of life. Screening tools such as MUST and MIRT in adults, and “Strong Kids” in children, are essential for early identification of at-risk patients. Pediatric patients tend to have more severe nutritional compromise than adults, and nutritional support during hospitalization contributes significantly to recovery.

References

1. Jabłońska B, Mrowiec S. Nutritional Status and Its Detection in Patients with Inflammatory Bowel Diseases. Nutrients. 2023 Apr 20;15(8):1991.
doi: 10.3390/nu15081991.
2. Pulley J, Todd A, Flatley C, Begun J. Malnutrition and quality of life among adult inflammatory bowel disease patients. JGH Open. 2019;4(3):454–60.
doi: 10.1002/jgh3.12278.
3. Valvano M, Capannolo A, Cesaro N, et al. Nutrition, Nutritional Status, Micronutrients Deficiency, and Disease Course of Inflammatory Bowel Disease. Nutrients. 2023 Aug 31;15(17):3824. doi: 10.3390/nu15173824.
4. Izquierdo LVP, Orduz-Diaz G, Frías-Ordoñez J, et al. P563 Nutritional screening in patients with inflammatory bowel disease: A challenge in the timely diagnosis of malnutrition and sarcopenia. J Crohns Colitis. 2024;18(Suppl_1). doi: 10.1093/ecco-jcc/jjad212.0693.

Disclosure

None declared