Verbund Katholischer Kliniken Düsseldorf

Abstract Background The performance of bowel preparation (BP) in patients with Crohn’s disease (CD) is unknown and may be suboptimal due to the presence of mucosal inflammation, strictures, pseudopolyps and bowel resection. We evaluated the reliability and validity of available BP scales in patients with CD. Methods Bowel preparation, in colonoscopy videos (N=50) from patients with CD (N=40) that represented a range of bowel preparation quality and endoscopic disease activity, was independently rated twice, separated by at least 2 weeks, by 3 central readers using the Boston Bowel Preparation Score (BBPS), modified BBPS, Harefield Cleansing Scale (HCS), Food and Drug Administration bowel cleansing assessment scale (FDA BCAS), and a 100-mm visual analogue scale (VAS) of bowel cleanliness. Endoscopic activity was assessed with the Simple Endoscopic Score for CD (SES-CD). All assessments were on endoscope insertion and withdrawal and in the ileum, right colon, transverse colon, left colon, and rectum to facilitate evaluation of the relationship between BP and SES-CD scores. Reliability of BP assessment was quantified using the intraclass correlation coefficient (ICC) and interpreted with benchmarks defined by Landis and Koch.1 Validity was assessed by within-patient correlation between each BP scale and the VAS across segments using mixed effect models. Correlation between BP quality and SES-SD scores by location was assessed using Spearman’s rho. Results Substantial (ICC ≥0.61) inter-rater reliability was observed for all BP scales and the VAS during insertion and withdrawal, except for the FDA BCAS, which had moderate (ICC ≥0.41) inter-rater reliability on insertion (Table 1). Intra-rater reliability was similarly substantial for all BP scales and almost perfect (ICC ≥0.81) for the VAS during insertion and withdrawal. Coefficients for the validity of all BP scales based on correlation with the VAS of bowel cleanliness exceeded 0.58 on both insertion and withdrawal. BP and endoscopic disease activity were negatively correlated in the colon, particularly in the left colon, suggesting that lower BP scores in this segment may result in higher SES-CD scores (Table 2). Conclusion Existing scales are reliable for the assessment of BP in patients with CD. These results provide a framework for scoring of BP quality in clinical trials for CD and support the inclusion of patients with CD for the evaluation of novel BP agents. Reference: 1. Landis J.R. and Koch G. G. Biometrics. 1977:33;159-74

BackgroundDespite effective treatment options, chronic kidney disease (CKD) has become a major cause of mortality worldwide due to the ever-increasing number of patients with type 2 diabetes mellitus (T2DM). Guideline-compliant, at least, annual screening of patients with T2DM is crucial to prevent renal disease progression. However, data on the prevalence of CKD in patients with T2DM and on screening frequency are limited. SMART-Finder is the first study to exclusively use data provided directly by patients via an adherence app to collect information on the prevalence of CKD, risk factors, disease management, and quality of life of patients with T2DM in Germany.ObjectiveThe primary objective of this study is to determine the proportion of patients with T2DM and an elevated urine albumin-to-creatinine ratio (UACR; albumin-to-creatinine ratio stage A2 and A3) at baseline and after 12 (±3) months. Secondary objectives include the proportion of patients who remain in or switch to another albumin-to-creatinine ratio classification category after 12 months, information on quality of life, disease awareness, and adherence rates, as well as the proportion of patients without any UACR-screening data. Recruitment occurs via push notification among MyTherapy app users with T2DM.MethodsThis is a single-arm, retrospective/prospective, observational, digital, patient-centered cohort study, with recruitment and data documentation via a health app. Required routine laboratory data are provided by treating physicians to their patients for data entry. The study population includes adult patients with T2DM documenting their data in the MyTherapy app using their own smartphone or tablet. Study participants are provided with a specifically developed electronic case report form containing questions on demographic and general data, quality of life, disease awareness, and laboratory values including estimated glomerular filtration rate, UACR, hemoglobin 1Ac, and blood pressure. Apart from demographic and general data, all data are collected at baseline and 12 months after the last UACR assessment. An automatically generated push notification reminds participants of the second data entry. The extracted and pseudonymized data are analyzed descriptively.ResultsThe enrollment period for this study started in February 2023 and shall end after 12 months or after the enrollment of 5000 patients. An interim analysis is planned 3 months after the inclusion of the first patient and the final analysis after 12 months of follow-up.ConclusionsOverall, the study will contribute to minimizing the existing data gap on the prevalence of CKD in patients with T2DM in Germany, provide important insights into the current disease management of patients with T2DM in everyday clinical practice in Germany, and support guideline-based care for the participating patients.International Registered Report Identifier (IRRID)PRR1-10.2196/44996

Background: Thalidomide has caused thalidomide embryopathy (TE) in more than 10,000 live-born children and is typically associated with phocomelia as well as several other abnormalities such as eye or ear malformations and internal organ defects. Nowadays, thalidomide survivors entered middle age, an age that is susceptible to breast cancer in women. Case Description: Sixty years after the well-known “Contergan Scandal”, we present a patient with thalidomide induced phocomelia receiving autologous free flap breast reconstruction. At the age of 49 the patient was diagnosed with multicentric breast cancer requiring neoadjuvant chemotherapy followed by mastectomy and right axillary sentinel lymph node biopsy. One year after mastectomy, an immediate-delayed autologous breast reconstruction using a deep inferior epigastric artery perforator flap was performed. The patient has been followed for 11 years now and still reports to be very satisfied with her reconstructed breast. Conclusions: We demonstrate that the deep inferior epigastric artery perforator flap is a feasible and safe technique to reconstruct the breast in a patient with TE. Given the well-known increased risk for mental disorders in that specific patient population, this case highlights the importance to restore body integrity by breast reconstruction. To the best of our knowledge there exists no literature on breast reconstruction in patients with TE or other physical impairments so far.

Correction to: Regelmäßiger Verzehr eines Brotes mit geringer postprandialer Insulinfreisetzung führt bei Erwachsenen mit Übergewicht oder Adipositas zur Gewichtsabnahme – eine randomisierte, kontrollierte DoppelblindstudieDiabetologie und Stoffwechsel 2022; 17(S 01): FV 19aDOI: 10.1055/s-0042-1746326

The aim of this study was to describe neuropsychiatric disorders of geriatric inpatients, to investigate associations of psychopathological symptomatology with clinical variables and to determine its impact on treatment outcome. From January to April 2018, treatment data of geriatric inpatient records were collected retrospectively. Clinical diagnoses of neuropsychiatric disorders, that is, depression, dementia, and delirium, were identified. Clinical correlations were calculated by χ2-tests and t-tests. Confounding variables for determined correlations were ascertained by analyses of variance. Functional measurements (Barthel Index, Timed Up and Go, Tinetti Test, and De Morton Immobility Index) were assessed at start and end of geriatric inpatient treatment. The mean age of the included 280 inpatients was 84 years, 71% were female, and the mean duration of treatment was 19.5 days. Twenty-nine percent of cases suffered from dementia, 27% from depression, and 15% from delirium at the time of geriatric treatment onset. Mentally ill inpatients, in addition, presented with a significantly higher number of comorbidities, compared to the group of mentally healthy inpatients. In contrast to the dementia and the delirium group of inpatients, prescription of analgetics was highest among the mentally healthy inpatients and inpatients with depression. Improvement was observed in each of the defined groups, and significant functional differences between all groups were found. Neuropsychiatric disorders occur quite often in a geriatric hospital department, especially depression and dementia. Clinical correlations determined in this study suggest a close relationship of mental and somatic disorders in geriatric inpatients. This study further demonstrates that neuropsychiatric disorders in multimorbid, elderly patients do not prevent functional improvement.

Die langfristige Wirksamkeit von Lebensstilinterventionen zur Behandlung des Typ 2 Diabetes mellitus (T2DM) wird hinterfragt. Daher haben wir die Langzeiteffekte des telemedizinischen Lebensstilinterventionsprogramms TeLiPro für Patienten mit T2DM in einer 36-Monats-Follow up-Studie untersucht.

Background Formula diets can improve glycemic control or can even induce remission in type 2 diabetes. We hypothesized that especially an individualized intense meal replacement by a low-carbohydrate formula diet with accompanied self-monitoring of blood glucose (SMBG) contributes to long-term improvements in HbA1c, weight, and cardiometabolic risk factors in poorly controlled type 2 diabetes. Methods Type 2 diabetes patients were randomized into either a moderate group (M-group) with two meal replacements/day (n = 160) or a stringent group (S-group) with three meal replacements/day (n = 149) during the first week of intervention (1300–1500 kcal/day). Subsequently, both groups reintroduced a low-carbohydrate lunch based on individual adaption due to SMBG in weeks 2–4. After week 4, breakfast was reintroduced until week 12. During the follow-up period, all of the participants were asked to continue replacing one meal per day until the 52-weeks follow-up. Additionally, an observational control group (n = 100) remained in routine care. Parameters were compared at baseline, after 12 and 52 weeks within and between all of the groups. Results 321 participants (83%) completed the acute meal replacement phase after 12 weeks and 279 participants (72%) the whole intervention after 52 weeks. Both intervention groups achieved improvements in HbA1c, fasting blood glucose, blood pressure, and weight (all p < 0.001) within 12 weeks. However, these results were not significantly different between both of the intervention groups. The estimated treatment difference in HbA1c reduction was (mean (95% confidence interval [CI]) -0.10% with 95% CI [−0.40; 0.21] also (p > 0.05) (S-group vs. M-group) not statistically different after 12 weeks. However, only the S-group showed a clinically relevant improvement in HbA1c of −0.81% [−1.06; −0.55] (p < 0.001) after 52 weeks of follow-up, whereas HbA1c was not statistically different between the M- and control group. Conclusion Individualized meal replacement with SMBG demonstrated beneficial effects on HbA1c and cardiometabolic parameters in type 2 diabetes. Furthermore, the initiation of a weight loss program with one week of full meal replacement (three meals per day) resulted in a clinically relevant long-term HbA1c reduction, as compared to an observational control group that had standard care.

ZUSAMMENFASSUNGSämtliche wissenschaftliche Leitlinien zur Behandlung des Typ-2-Diabetes sehen als Basistherapie eine Änderung des Lebensstils vor. Jedoch wird diese Therapieoption in der klinischen Praxis aus verschiedenen Gründen nur habherzig verfolgt. Zwei aktuelle Studien, die englische DiRECT und die deutsche TeLiPro, haben nun diese Basistherapie in radikaler Form umgesetzt und ganz erstaunliche Ergebnisse erzielt. In DiRECT gelang es, fast 50 % der Studienteilnehmer mit einer mittleren Diabetesdauer von 3 Jahren in eine klinische Remission zu bringen. In TeLiPro wiederum wurde bei einer 11-jährigen Diabetesdauer der HbA1c-Wert um 0,8 % gesenkt, obwohl gleichzeitig die antidiabetische Therapie reduziert wurde. Diese neuen Befunde sind gesundheitspolitisch eine neue Option, die kontinuierlich steigenden Ausgaben für Diabetesmedikamente zu begrenzen. TeLiPro wird in Deutschland bereits von privaten, aber auch gesetzlichen Krankenkassen ihren Versicherten angeboten und erstattet.