Christien Janneke van der Woude

Introduction: Workplace‐based assessments (WBAs) are central to evaluating clinical performance in clerkships, yet their design and implementation remain challenging. One major challenge is that WBAs inevitably rely on subjective human judgement. However, little is known about how undergraduate students perceive subjectivity in assessment and what they consider trustworthy assessment practices. We therefore explored undergraduate medical students' perceptions of WBAs during clerkships, using a strengths‐based approach to envision an ideal WBA system. Methods: We organised six focus groups ( N = 24) guided by Appreciative Inquiry. Focus group discussions focused on memorable assessment experiences, underlying values, desired changes and visions of an ideal system. We used Reflexive Thematic Analysis within a constructionist paradigm through iterative coding, thematic mapping, analytic memos and team discussions to ensure rigour and reflexivity. Results: Three themes represent foundational conditions for an ideal WBA system: (1) Being seen , acknowledging students as individuals through personalised feedback; (2) Growth , conceptualising WBAs as a longitudinal process supporting learning and career exploration; and (3) Feeling safe , emphasising a meaningful dialogue and a culture of trust. A fourth theme, Balancing ideals , captured the inherent tensions between competing ideals. Importantly, students perceived assessment as trustworthy not when subjectivity was eliminated but when it was considered accountable and conducive to fair outcomes. Discussion: Our findings suggest that trustworthy WBA systems are best understood as sets of deliberate compromises, negotiated in ongoing dialogue with students and assessors, rather than one‐size‐fits‐all frameworks. By adopting a strengths‐based approach, this study reframes familiar assessment concepts as conditions for enabling trust, rather than as solutions to deficits. These findings advance our understanding of how to embed subjectivity into WBAs in a trustworthy manner and offer a student‐informed approach for strengthening WBAs design in undergraduate medical education.

: This analysis evaluates the feasibility and psychometric properties of daily digital cognitive assessments (DCAs) delivered on smartphones using data from the large, international Identifying Digital Endpoints to Assess FAtigue, Sleep and acTivities of daily living in Neurodegenerative disorders and Immune-mediated inflammatory diseases (IDEA-FAST) study. The data we analyse were collected from patients with neurodegenerative diseases (NDDs) and immune-mediated inflammatory diseases (IMIDs), and healthy controls (a subset who participated in all phases of the study, total N=1005) in their own homes. These data were obtained alongside data from other devices that monitored physiology, kinematics, and sleep quality. Following a baseline visit, participants were remotely monitored via three scheduled daily sessions for 6-7 days in each of 4 active assessment phases (APs). APs were separated by 6-week intervals. Daily schedules comprised a morning psychomotor vigilance task (PVT) with eDiary, afternoon session (eDiary only), and an evening digit symbol substitution task (DSST) with eDiary. We evaluated session coverage using logistic mixed effects, test-retest reliability using ICCs, disease impacts on performance using linear mixed effect ANCOVA, and familiarisation using linear mixed effects. Overall coverage was 66.7% for the PVT and 76.2% for the DSST, with no significant differences between the healthy volunteers and disease cohorts. Coverage varied significantly by time-of-day (Evening > Morning > Afternoon), and improved with age, with an interaction revealing session time-of-day affected older participants less, all p < .001. Coverage was highest in AP 1 and reduced in subsequent APs. AP-day effects on coverage interacted significantly with AP, with a modest decline over AP 1, and the pattern reversed in APs 2-4. Baseline reliability was good (> .70) for both PVT mean reaction time and DSST total correct across all cohorts, and the movement-based measure from the DSST ranged [.54, .82], with lower values in the Parkinson’s Disease and Primary Sjögren’s Syndrome cohorts. Both tasks showed significant cohort effects, with performance in IMID cohorts intermediate between healthy controls and NDD. Longitudinal analysis revealed significant familiarisation effects in DSST. This was greatest in healthy controls, with significant attenuation of these effects in disease cohorts. No effect of familiarisation was seen in the PVT. Collectively, these results support the usefulness of at-home cognitive assessment on smartphones. Brief measures of cognition can be captured remotely in disease as well as controls with good adherence and sensitivity to distinguish known patient groups from healthy controls.

Background and Aims: Inflammatory bowel disease (IBD) often coincides with pregnancy, and disease activity during pregnancy increases the risk of adverse outcomes. We aimed to determine how disease course before conception influences relapse risk during pregnancy, adjusting for established risk factors. Methods: In this multicenter, retrospective cohort study, we included adult women with IBD who were pregnant during treatment at one of three university hospitals between 2017 and 2022. Using generalized estimating equations, we evaluated associations between relapse during pregnancy and pre-conceptional flares, categorized into three time intervals. Analyses were adjusted for phenotype, disease duration, surgical history, biologic use, smoking, and assisted reproduction. Interaction analyses were conducted with matched non-pregnant women. Results: We included 386 women (63.4% Crohn’s disease, 36.6% ulcerative colitis) with 476 pregnancies. Pre-conceptional flares were significantly associated with relapse if they occurred <3 months [adjusted odds ratio (aOR) 5.289, 95% CI 2.6-10.8, P < .001] or 3-6 months prior to conception (aOR 2.910, 95% CI 1.0-8.2, P = .043), but not 6-12 months prior (aOR 1.636, 95% CI 0.8-3.2, P = .146). Other predictors were not significantly associated with relapse. There was no significant interaction between pregnancy and pre-conceptional disease activity. Conclusions: This large multicenter study demonstrates that disease activity within 6 months before conception significantly increases the risk of relapse during pregnancy in women with IBD. Our study is the first to assess both the pre-conceptional disease course and a broad set of known risk factors in a real-world cohort.

Background: Fatigue is a prevalent and debilitating symptom in many chronic conditions, including immune-mediated inflammatory diseases (IMIDs) and neurodegenerative diseases (NDDs). Fatigue often fluctuates significantly within and between days, yet traditional patient-reported outcomes (PROs) typically rely on recall periods of a week or more, potentially missing these short-term variations. The development of digital tools, such as electronic diaries (eDiaries), offers a unique opportunity to collect granular, real-time data. However, the feasibility, adherence, and comparability of eDiary-based assessments to established PROs require further investigation. Objective: This study aimed to evaluate the feasibility and acceptability of using a high-frequency eDiary to capture intraday variability in fatigue and to compare eDiary data with scores obtained from the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), a validated weekly recall PRO. Methods: Data were collected from 159 participants enrolled in the IDEA-FAST (Identifying Digital Endpoints to Assess Fatigue, Sleep and Activities in Daily Living in Neurodegenerative Disorders and Immune-Mediated Inflammatory Diseases) feasibility study; a 4-week prospective observational study conducted at 4 European centers. Participants included individuals with NDDs (n=39), IMIDs (n=78), and healthy volunteers (n=42). Participants used an eDiary to report their physical and mental fatigue levels up to 4 times daily on a 7-point Likert scale (0=low and 6=high). Adherence was calculated as the proportion of completed eDiary entries relative to the total expected entries. Correlations between averaged eDiary scores and weekly FACIT-F scores were analyzed. Results: Adherence to the eDiary protocol was 5505/8880 (61.99%) overall, varying by cohort, with the highest adherence (1117/1200, 93.07%) observed in the primary Sjögren syndrome cohort and the lowest adherence in the Parkinson disease (410/960, 42.7%) and Huntington disease (320/720, 44.4%) cohorts. The average adherence was 430/1680 (43.45%) in the NDD cohorts and 3367/4560 (73.84%) in the IMID cohorts. Fatigue levels showed clear diurnal variation, with significantly higher fatigue reported in the evening compared to the morning (P<.001). A moderate correlation (Spearman=0.46, P<.001) was observed between eDiary fatigue scores and FACIT-F scores, with stronger cohort-specific associations for certain FACIT-F items. These results indicate that eDiaries provide complementary insights to weekly PROs by capturing intraday fluctuations in fatigue. Conclusions: This study demonstrates the feasibility, acceptability, and validity of using high-frequency eDiaries to assess fatigue in chronic conditions. By effectively detecting intra- and interday fatigue variations, eDiaries complement traditional PROs such as FACIT-F, offering a more nuanced understanding of fatigue patterns. Future research should explore optimized eDiary protocols to balance participant burden with data granularity.

Background: Inflammatory bowel disease (IBD) is often diagnosed in young adults, and therefore frequently coincides with pregnancy. Patients may require surgery that includes (temporary) stoma placement. Literature on the occurrence of stoma-complications during pregnancy and the effect on pregnancy outcomes is limited. To evaluate stoma- complications peri- and postpartum, a retrospective study was performed in women who were pregnant while having a stoma. Methods: This multicentre cohort and survey study included all pregnant patients with IBD and a stoma who delivered between 2016 and 2023 from 5 Dutch university hospitals. Stoma-complications and pregnancy outcomes were retrospectively collected from electronic patient files. A questionnaire assessed patient-reported complications and long-term stoma-related complaints. Results: In total, 50 patients were included (median age at conception 31.0 years; 55.2% Crohn’s disease and 44.8% ulcerative colitis), comprising 67 pregnancies, 5 of which ended in pregnancy loss. Stoma complications occurred in 44 full-term pregnancies (71.0%), most commonly obstruction (35.5%) and decreased output (29.0%). Surgery was required in four pregnancies due to obstruction (n = 3) and prolapse (n = 2). In the first-year postpartum, 7 patients required surgery for stoma-complications. Amongst 29 women who completed the questionnaire, 10 (34.5%) reported unresolved complications 6 months postpartum. Cesarean sections were performed in 31 (50.0%) pregnancies. Adverse pregnancy outcomes included prematurity (n = 9, 14.5%), low birth weight (n = 9, 14.5%), and dysmaturity (n = 5, 8.1%). Conclusions: Pregnancy with a stoma is feasible, though manageable complications often occur. Counseling before pregnancy and close monitoring of symptoms during pregnancy and postpartum are essential for women with IBD and a stoma.

BackgroundRisk stratification for endoscopic post-operative recurrence (ePOR) in Crohn's disease (CD) is required to identify patients who would benefit most from initiation of prophylactic medication and intensive monitoring of recurrence.AimsTo assess the current evidence on patient-related, microbial, surgical and histopathological risk factors for ePOR in patients with CD after ileocolic (re-)resection.MethodsMultiple online databases (Embase, MEDLINE, Web of Science and Cochrane Library) were searched up to March 2024. Studies with reported associations of patient-related, microbial, surgical and/or histopathological factors for ePOR (i.e., Rutgeerts' score >= i2 or modified Rutgeerts' score >= i2a) were included. The risk of bias was assessed with the Newcastle-Ottawa Scale for observational cohort studies and case-control studies.ResultsIn total, 47 studies were included (four RCTs, 29 cohort studies, 12 case-control studies, one cross-sectional study and one individual participant data meta-analysis) including 6006 patients (median sample size 87 patients [interquartile range 46-170]). Risk of bias assessment revealed a poor quality in 41% of the studies. An association was reported in multiple studies of ePOR with active smoking at and post-surgery, male sex and prior bowel resection. A heterogeneous association with ePOR was reported for other risk factors included in the current guidelines (penetrating disease, perianal disease, younger age, extensive small bowel disease and presence of granulomas in the resection specimen or myenteric plexitis in the resection margin), and other patient-related, microbial, surgical and histopathological factors.ConclusionRisk factors for ePOR in international guidelines are not consistently reported as risk factors in current literature except for active smoking and prior bowel resection. To develop evidence-based, personalised strategies, large prospective studies are warranted to identify risk factors for ePOR. Validation studies of promising (bio)markers are also required. Risk factors for ePOR in international guidelines are not consistently reported as risk factors in the current literature except for active smoking and a prior bowel resection. To develop evidence-based and personalised strategies, future large prospective studies are warranted for the identification of risk factors for ePOR in patients with CD. In addition, validation studies of promising (bio)markers are required.image

BACKGROUND: Endorectal advancement flap repair is often performed for the treatment of cryptoglandular transsphincteric fistulas. However, this procedure fails in approximately 1 of 4 patients. Based on its supposed healing properties, platelet-rich plasma might enhance the outcome of this procedure. OBJECTIVE: To evaluate and compare the short-term and long-term outcomes after endorectal advancement flap repair with and without platelet-rich plasma injection in patients with a cryptoglandular transsphincteric fistula. DESIGN: Retrospective cohort study. SETTING: Tertiary referral hospital for proctology in the Netherlands. PATIENTS: Consecutive patients with a cryptoglandular transsphincteric fistula. Inverse propensity score–weighted comparison was used to adjust for confounding and selection bias. INTERVENTIONS: Endorectal advancement flap repair with and without platelet-rich plasma injection. MAIN OUTCOME MEASURES: Clinical fistula closure within 1 year without need for a reintervention (primary healing), clinical fistula closure within 1 year corrected for reinterventions (secondary healing), overall fistula healing within 1 year, and long-term outcomes assessed by a questionnaire. RESULTS: In total, 219 patients underwent an endorectal advancement flap repair. In 88 patients (40.2%), platelet-rich plasma was injected. No significant difference was observed in primary healing (67.0% vs 69.5%, p = 0.71), secondary healing (37.5% vs 43.5%, p = 0.60), or overall healing (73.9% vs 77.1%, p = 0.58) between patients treated with and without platelet-rich plasma injection. Long-term follow-up was available in 67.1% of the patients with a mean follow-up of 6.8 years (SD: 3.7 years). Among all patients who reached fistula healing, whether primary or secondary, within 1 year and had available long-term follow-up data, recurrence rates were also not significantly different (6.3% vs 2.9%, p = 0.37). Propensity score–weighted analysis showed that patients treated with a platelet-rich plasma injection were not more likely to achieve primary healing (OR 1.0; 95% CI, 0.5–1.9), secondary healing (OR 1.1; 95% CI, 0.2–3.2), overall healing (OR 0.9; 95% CI, 0.5–1.7), or recurrence at long-term follow-up (OR 1.1; 95% CI, 0.4–18.8) compared with patients without platelet-rich plasma injection. LIMITATIONS: Retrospective design, lack of postoperative imaging, and assessment of long-term follow-up using a questionnaire. CONCLUSION: Addition of platelet-rich plasma injection does not improve the short-term and long-term outcomes of endorectal advancement flap repair in patients with a cryptoglandular transsphincteric fistula treated in a tertiary referral center. See Video Abstract. ADICIÓN DE PLASMA RICO EN PLAQUETAS A LA REPARACIÓN DEL COLGAJO DE AVANCE ENDORRECTAL NO MEJORA LA CURACIÓN DE LAS FÍSTULAS TRANSESFINTERIANAS CRIPTOGLANDULARES: ANTECEDENTES: La reparación con colgajo de avance endorrectal a menudo se realiza para el tratamiento de fístulas transesfinterianas criptoglandulares. Sin embargo, este procedimiento falla en aproximadamente uno de cada cuatro pacientes. Basándose en sus supuestas propiedades curativas, el plasma rico en plaquetas (PRP) podría mejorar el resultado de este procedimiento. OBJETIVO: Evaluar y comparar los resultados a corto y largo plazo después de la reparación con colgajo de avance endorrectal con y sin inyección de PRP en pacientes con una fístula transesfintérica criptoglandular. DISEÑO: Estudio de cohorte retrospectivo. ÁMBITO: Hospital terciario de referencia para proctología en los Países Bajos. PACIENTES: Pacientes consecutivos con fístula transesfintérica criptoglandular. Se utilizó una comparación ponderada por puntuación de propensión inversa para ajustar los factores de confusión y el sesgo de selección. INTERVENCIONES: Reparación del colgajo de avance endorrectal con y sin inyección de PRP. PRINCIPALES MEDIDAS DE VALORACIÓN: Cierre clínico de la fístula dentro de un año sin necesidad de reintervención (cicatrización primaria), cierre clínico de la fístula dentro de un año corregido por reintervenciones (cicatrización secundaria), curación general de la fístula dentro de un año y resultados a largo plazo evaluados mediante un cuestionario. RESULTADOS: En total, 219 pacientes se sometieron a una reparación con colgajo de avance endorrectal. En 88 pacientes (40,2%) se inyectó PRP. No se observaron diferencias significativas en la curación primaria (67,0% frente a 69,5%, p = 0,71), curación secundaria (37,5% frente a 43,5%, p = 0,60) y curación general (73,9% frente a 77,1%, p = 0,58).) entre pacientes con y sin inyección de PRP, respectivamente. El seguimiento a largo plazo estuvo disponible en el 67,1% de los pacientes con un seguimiento medio de 6,8 años (desviación estándar: 3,7 años). Dentro de todos los pacientes que alcanzaron la curación de la fístula, tanto primaria como secundaria, dentro de un año y tenían datos de seguimiento a largo plazo disponibles, las tasas de recurrencia tampoco fueron significativamente diferentes (6,3% vs. 2,9%, p = 0,37). El análisis ponderado por puntuación de propensión mostró que los pacientes tratados con una inyección de PRP no tenían más probabilidades de lograr la curación primaria (odds ratio [OR] 1,0; intervalo de confianza [IC] del 95 %: 0,5 – 1,9), curación secundaria (OR 1,1; IC del 95 % 0,2 – 3,2), curación general (OR 0,9; IC 95 % 0,5 – 1,7) o recurrencia en el seguimiento a largo plazo (OR 1,1; IC 95 % 0,4 – 18,8) en comparación con pacientes sin inyección de PRP. LIMITACIONES: Diseño retrospectivo, falta de imágenes postoperatorias y evaluación del seguimiento a largo plazo mediante un cuestionario. CONCLUSIÓN: La adición de la inyección de PRP no mejora el resultado a corto y largo plazo de la reparación con colgajo de avance endorrectal en pacientes con una fístula transesfintérica criptoglandular tratados en un centro de referencia terciario. (Traducción— Dr. Ingrid Melo)

INTRODUCTION: The prognostic value of the modified Rutgeerts score (mRS) in patients with Crohn's disease (CD) needs to be further elucidated. This study assessed the prognostic value of the mRS for long-term outcomes after primary ileocecal resection in patients with CD. METHODS: Patients with CD after primary ileocecal resection with an available mRS at first postoperative ileocolonoscopy (index mRS) were retrospectively included. The primary outcome was surgical recurrence. Secondary outcomes were clinical recurrence and progression to severe endoscopic recurrence (≥i3). Cox proportional hazard models were used to assess the association between index mRS and outcomes. RESULTS: Six hundred fifty-two patients were included (mean follow-up: 6.4 years, SD: 4.6). Surgical recurrence rates were 7.7%, 5.3%, 12.9%, 19.1%, 28.8%, 47.8% for index mRS i0, i1, i2a, i2b, i3, and i4, respectively. Clinical recurrence occurred in 42.2% (i0), 53.7% (i1), 58.5% (i2a), 80.2% (i2b), 79.4% (i3), and 95.3% (i4) of patients. Progression to severe endoscopic recurrence occurred in 21.1% (i0), 33.9% (i1), 26.8% (i2a), and 33.3% (i2b) of patients. An index mRS of i2b (adjusted hazard ratio [aHR] 3.0; 1.5–5.6), i3 (aHR 4.0; 2.0–7.9) and i4 (aHR 8.0; 4.0–16.0) were associated with surgical recurrence. An index mRS of i1 (aHR 1.7; 1.2–2.4), i2a (aHR 1.7; 1.2–2.4), i2b (aHR 4.4; 3.2–6.0), i3 (aHR 3.6; 2.5–5.2), and i4 (aHR 7.3; 4.8–10.9) were associated with clinical recurrence. An index mRS of i1 (aHR 2.0; 1.1–3.7) or i2b (aHR 2.5; 1.4–4.6) was associated with progression to severe endoscopic recurrence. DISCUSSION: The increasing mRS corresponds closely with the risk of surgical and clinical recurrence. An index mRS ≥ i2b is associated with surgical recurrence, an index mRS ≥ i1 is associated with clinical recurrence, and i1 or i2b with progression to severe endoscopic recurrence. These results support tight monitoring of disease activity and treatment optimization in patients with ileal lesions and a more conservative management in patients with anastomotic lesions.

Introduction After successful induction, a subset of patients (pts) with Crohn’s disease (CD) experience a secondary loss of response (LoR) to ustekinumab (UST) maintenance therapy. Dose intensification may assist in regaining response. Objectives The phase 3b randomized, double-blind, multicenter POWER study evaluated the efficacy and safety of a single intravenous (IV) re-induction UST dose vs continued UST subcutaneous (SC) treatment in CD pts with LoR to standard UST every 8 weeks (q8w) maintenance therapy. Methodology Adults with moderately–severely active CD who initially responded to UST IV induction therapy per label and subsequently experienced LoR were included. LoR for inclusion was defined as CDAI score of≥220 and≤450, in addition to elevated CRP (>3mg/L), fCal (>250mg/kg)/endoscopy performed≤3 months before W0 with evidence of active CD (≥1 ulcerations in ileum and/or colon). At baseline (W0), pts received either ~6mg/kg IV UST/SC placebo (IV arm) or IV placebo/SC UST 90mg (SC arm), followed by SC UST 90mg dosing in both groups at W8/16. Clinical and biomarker assessments were made at W0/8/16 and optional ileocolonoscopy at W0/16. Primary endpoint: clinical response (Cres;≥100 point decrease from W0/CDAI<150) at W16. Additional outcome measures included clinical, biomarker, endoscopic and quality of life endpoints assessed at W8/16. Outcome The analysis set comprised 215 pts at W0 (IV,108;SC,107). At W16, 92.6% and 86.0% completed treatment from IV and SC arms, respectively. In both arms (IV, 58.3%;SC, 57.9%) most pts experienced≥2 biologic failures before initiating UST ([Table 1]). At W16, 49.1% in IV arm and 37.4% in SC arm achieved Cres (p=0.089). Percentages of pts with normalized fCal, normalized CRP and/or fCal, endoscopic remission and improvement, and improvement in IBDQ score were greater in IV vs SC arm ([Table 2]). At W16, similar proportions of pts had≥1 adverse event (AE) (IV, 60.2%;SC, 61.7%) and serious AEs (IV, 5.6%;SC, 5.6%). The proportions of pts with infections were similar between arms (IV, 23.1%;SC, 21.5%), with only 1 serious infection in each arm. Conclusion The CDAI-based primary endpoint at W16 was formally not met. However, pts in this heavily pre-treated population who received IV re-induction showed consistent, clinically meaningful improvements at W16 compared with those receiving SC, particularly for objective endpoints, including inflammatory biomarkers and endoscopic outcomes as well as pain/diarrhea scores. präsentiert in der Sitzung: CED – Teamwork worksSamstag, 16. September 2023, 10:15–11:45, Saal X01 Article published online: 28 August 2023 © 2023. Thieme. All rights reserved. Georg Thieme Verlag Rüdigerstraße 14, 70469 Stuttgart, Germany