scholarly journals DOP061. Prospective,Observational Study of the Therapeutic Management of Mild to Moderate Ulcerative Colitis (Observatoire Prospectif, longiTudinal dans la prise en charge de la rectocolite heMorragiqUe legere a Moderee, OPTIMUM): follow-up at 2 years

2015 ◽  
Vol 9 (suppl 1) ◽  
pp. S59-S59
Keyword(s):  
Ulcerative Colitis ◽  
Observational Study ◽  
Prospective Observational Study ◽  
Prise En Charge ◽  
Therapeutic Management ◽  
Rectocolite Hémorragique

scholarly journals A Global, Prospective, Observational Study Measuring Disease Burden and Suffering in Patients With Ulcerative Colitis, Using the Pictorial Representation of Illness and Self-measure Tool

2020 ◽  
Author(s):  
Subrata Ghosh ◽  
Tom Sensky ◽  
Francesc Casellas ◽  
Louis-Charles Rioux ◽  
Tariq Ahmad ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Observational Study ◽  
Disease Severity ◽  
Disease Burden ◽  
Prospective Observational Study ◽  
Illness Perception ◽  
Rank Correlation ◽  
Pictorial Representation ◽  
The Impact

Abstract Background The understanding the Impact of ulcerative COlitis aNd Its assoCiated disease burden on patients study [ICONIC] was a 2-year, global, prospective, observational study evaluating the cumulative burden of ulcerative colitis [UC] using the Pictorial Representation of Illness and Self-Measure [PRISM] tool that is validated to measure suffering, but has not previously been used in UC. Methods ICONIC enrolled unselected outpatient clinic attenders with recent-onset UC. Patient- and physician-reported outcomes including PRISM, the Short Inflammatory Bowel Disease Questionnaire [SIBDQ], the Patient Health Questionnaire [PHQ-9], and the Simple Clinical Colitis Activity Indexes [patient: P-SCCAI; physician: SCCAI] were collected at baseline and follow-up visits every 6 months. Correlations between these measures were assessed using Spearman’s rank correlation coefficient. Results Overall, 1804 evaluable patients had ≥1 follow-up visit. Over 24 months, mean [SD] disease severity measured by P-SCCAI/SCCAI reduced significantly from 4.2 [3.6]/3.0 [3.0] to 2.4 [2.7]/1.3 [2.1] [p <0.0001]. Patient-/physician-assessed suffering, quantified by PRISM, reduced significantly over 24 months [p <0.0001]. P-SCCAI/SCCAI and patient-/physician-assessed PRISM showed strong pairwise correlations [rho ≥0.60, p <0.0001], although physicians consistently underestimated these disease severity and suffering measures compared with patients. Patient-assessed PRISM moderately correlated with other outcome measures, including SIBDQ, PHQ-9, P-SCCAI, and SCCAI (rho = ≤-0.38 [negative correlations] or ≥0.50 [positive correlations], p <0.0001). Conclusions Over 2 years, disease burden and suffering, quantified by PRISM, improved in patients with relatively early UC. Physicians underestimated burden and suffering compared with patients. PRISM correlated with other measures of illness perception in patients with UC, supporting its use as an endpoint reflecting patient suffering.

scholarly journals Safety of High-Dose Dabigatran in Elderly and Younger Patients with a Low Bleeding Risk: A Prospective Observational Study

Cardiology ◽  
2021 ◽  
pp. 1-5
Author(s):  
Aharon Erez ◽  
Gregory Golovchiner ◽  
Robert Klempfner ◽  
Ehud Kadmon ◽  
Gustavo Ruben Goldenberg ◽  
...  
Keyword(s):  
Observational Study ◽  
Elderly Patients ◽  
Prospective Observational Study ◽  
Bleeding Risk ◽  
The Elderly ◽  
High Dose ◽  
World Population ◽  
Younger Patients ◽  
End Point

<b><i>Introduction:</i></b> In patients with atrial fibrillation (AF) at risk for stroke, dabigatran 150 mg twice a day (DE150) is superior to warfarin for stroke prevention. However, there is paucity of data with respect to bleeding risk at this dose in elderly patients (≥75 years). We aimed to evaluate the safety of DE150 in comparison to warfarin in a real-world population with AF and low bleeding risk (HAS-BLED score ≤2). <b><i>Methods:</i></b> In this prospective observational study, 754 consecutive patients with AF and HAS-BLED score ≤2 were included. We compared outcome of elderly patients (age ≥75 tears) to younger patients (age &#x3c;75 years). The primary end point was the combined incidence of all-cause mortality, stroke, systemic emboli, and major bleeding event during a mean follow-up of 1 year. <b><i>Results:</i></b> There were 230 (30%) elderly patients, 151 patients were treated with warfarin, and 79 were treated with DE150. Fifty-two patients experienced the primary endpoint during the 1-year follow-up. Among the elderly, at 1-year of follow-up, the cumulative event rate of the combined endpoint in the DE150 and warfarin was 8.9 and 15.9% respectively (<i>p</i> = 0.14). After adjustment for age and gender, patients who were treated with DE150 had a nonsignificant difference in the risk for the combined end point as patients treated with warfarin both among the elderly and among the younger population (HR 0.58, 95% C.I = 0.25–1.39 and HR = 1.12, 95% C.I 0.62–2.00, respectively [<i>p</i> for age-group-by-treatment interaction = 0.83). <b><i>Conclusions:</i></b> Our results suggest that Dabigatran 150 mg twice a day can be safely used among elderly AF patients with low bleeding risk.

scholarly journals The role of rehabilitation measures in reintegration of children with brain tumours or leukaemia and their families after completion of cancer treatment: a study protocol

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e014505 ◽  
Author(s):  
Mona Leandra Peikert ◽  
Laura Inhestern ◽  
Corinna Bergelt
Keyword(s):  
Observational Study ◽  
Cancer Treatment ◽  
Childhood Cancer ◽  
Quantitative Study ◽  
Prospective Observational Study ◽  
Daily Life ◽  
Oncological Rehabilitation ◽  
Rehabilitation Measures

IntroductionFor ill children as well as for their parents and siblings, childhood cancer poses a major challenge. Little is known about the reintegration into daily life of childhood cancer survivors and their families. The aim of this prospective observational study is to further the understanding of the role of rehabilitation measures in the reintegration process of childhood leukaemia or brain tumour survivors and their family members after the end of cancer treatment.Methods and analysisThis prospective observational study consists of three study arms: a quantitative study in cooperation with three German paediatric oncological study registries (study arm 1), a quantitative study in cooperation with a rehabilitation clinic that offers a family-oriented paediatric oncological rehabilitation programme (study arm 2) and a qualitative study at 12-month follow-up including families from the study arms 1 and 2 (study arm 3). In study arm 1, children, parents and siblings are surveyed after treatment (baseline), 4–6 months after baseline measurement and at 12-month follow-up. In study arm 2, data are collected at the beginning and at the end of the rehabilitation measure and at 12-month follow-up. Families are assessed with standardised questionnaires on quality of life, emotional and behavioural symptoms, depression, anxiety, fear of progression, coping and family functioning. Furthermore, self-developed items on rehabilitation aims and reintegration into daily life are used. Where applicable, users and non-users of rehabilitation measures will be compared regarding the outcome parameters. Longitudinal data will be analysed by means of multivariate analysis strategies. Reference values will be used for comparisons if applicable. Qualitative data will be analysed using thematic analysis.Ethics and disseminationThis study has been approved by the medical ethics committee of the Medical Chamber of Hamburg. Data will be published in peer-reviewed journals and presented at conferences.

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