Patterns of disease and severity in bipolar disorder: Retrospective data from a large multinational longitudinal study (WAVE-bd)

IntroductionThe Wide AmbispectiVE study of the clinical management and burden of bipolar disorder (BD) (WAVE-bd; NCT01062607) is ongoing to address limitations of longitudinal BD studies to-date focused on single disease phases or treatment.Aim/ObjectiveTo describe baseline bipolar mood state and severity in a cohort of patients with BD.MethodsMultinational, multicentre, non-interventional, longitudinal study of patients diagnosed with BD-I or BD-II with ≥1 mood event in the preceding 12 months (retrospective data collection from index mood event to enrolment, followed by 9-14 months’ prospective follow-up). Site and patient selection provided a sample representative of bipolar populations. The study includes descriptive analyses of demographics, diagnosis and medical history.Results2880 patients (mean age 46.5 years [SD: 13.3]; 62.0% female) were recruited March to September 2010: 1989 (69.1%) BD-I and 891 (30.9%) BD-II. Time (years) from first symptoms to diagnosis was 2.9 [SD: 6.6] (BD-I) and 4.4 [SD: 8.0] (BD-II). Of the total population, 20.8% lived alone (13.9% BD-I, 6.9% BD-II), 36.7% were employed (24.0% BD-I, 12.7% BD-II) and 13.3% unemployed (9.5% BD-I, 3.8% BD-II). Disease status at inclusion (BD-I, BD-II, respectively [mild, moderate, severe]) included hypomania (7.9% [67.7%, 31.0%, 1.3%], 6.5% [70.7%, 29.3%, 0%]), mania (7.1% [26.1%, 47.2%, 26.8%], 0%), euthymia (58.6%, 60.3%), depression (19.7% [38.8%, 47.7%, 13.5%], 31.1% [41.2%, 46.9%, 11.9%]) and mixed (5.7% [30.1%, 46.9%, 23.0%], 0%).ConclusionsThis ongoing study provides detailed insight into a large BD population, showing the majority with euthymia and an important proportion with depression both in BD-I and BD-II patients.

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Therapy of Acquired Aplastic Anemia (AA) with Rabbit Antithymocyte Globulin (rATG): A Retrospective Analysis by the Working Group on Non-Malignant Disorders of Hematopoiesis of the German Society of Hematology and Oncology (DGHO),

Blood ◽

10.1182/blood.v118.21.3434.3434 ◽

2011 ◽

Vol 118 (21) ◽

pp. 3434-3434

Author(s):

Britta Höchsmann ◽

Christiane Neher ◽

Ulrich Germing ◽

Janne Vehreschild ◽

Juliane Eggermann ◽

...

Keyword(s):

Data Collection ◽

Aplastic Anemia ◽

Research Funding ◽

Response Rate ◽

Retrospective Data ◽

First Line ◽

Off Label ◽

Best Response ◽

Retrospective Data Collection

Abstract Abstract 3434 Introduction: Several clinical trials established treatment with horse ATG (hATG) and cyclosporine A (CsA) as standard treatment of AA in patients (pts) who are not candidates for stem cell transplantation (SCT). In 2007 the hATG brand Lymphoglobulin® was withdrawn from the market. As the hATG brand ATGAM®, is not approved in Europe, hATG was replaced by rabbit ATG (rATG). Recently a large prospective randomized one-center study from NIH, USA comparing hATG ATGAM®/CsA and rATG Thymoglobulin®/CsA in untreated AA showed significantly lower response rates and survival with rATG. To obtain further information on rATG treatment in an unselected AA population, especially with a higher median of age and use of different rATG dosages we performed a retrospective data collection of first line rATG therapy on several centers. This shall reflect outcome after rATG in a real-world situation. Methods: Retrospective data collection and analysis of first line rATG treatment of AA after approval by Ethical Committee. Results: Up to now retrospective data of 64 pts from 18 centres in Germany were analysed. Characteristics of the pts: 30 male, 34 female; median age at time of therapy 54 years (6–80 years); 87.5% of pts had idiopathic AA. 51.6% of pts had severe AA, 32.8% very severe AA and 15.6% non-severe AA. Median granulocyte count was 0.3 G/l. 86% of the pts required red blood cell and 92% platelet transfusions. 56 of the evaluable pts received Thymoglobulin® and 5 pts Fresenius ATG S®. 52 of the 56 Thymoglobulin®-treated pts got this therapy in the years 2007–2011, i.e. not as deliberate primary choice of rATG but because hATG was no longer available. Median daily dose of Thymoglobulin® was 3.5 mg/kg (range from 2.5 – 3.75 mg/kg) for 5 days. 62 of 64 pts received additional immunosuppressive therapy with CsA and 19 of 64 pts received G-CSF. The median follow-up for surviving pts was 558.5 days (range, 78–3800 days). Response rates at time of best response of pts were CR in 10/58 pts (17%), PR in 18/58 pts (31%) and NR in 30/58 pts (52%) (only surviving patients with a minimum follow-up of 120 days were analyzed). Median interval to best response was 217 days. Response rate (PR+CR) was 16/33 (48.5%) in pts who received a Thymoglobulin® dose of > 3.5 –3.75 mg/kg/day versus only 4/14 (28.6%) group of 14 pts with a dose of > 2.5 to < 3.5 mg/kg/day (p=0.17; Fisher`s exact test). Relapses occurred in 3/28 responders and clonal evolution was observed in 3 pts (2 PNH, 1 MDS). Eighteen of 63 evaluable pts received allogenic SCT after ATG-therapy and were censored at the date of SCT. 23% of 44 pts without SCT died. In 6 of these 10 pts death was caused by infections. Other causes of death were bleeding, cardiac event, acute respiratory distress syndrome, adynamia. Overall probability of survival at 3 years was 75.8% (95% confidence interval (CI): 61.8 – 89.9%) and survival censored for SCT was 79.9% (CI: 66.0–92.8%). Survival was significantly better in responders (PR and CR) (94.1% at 3 years; CI: 82.9–100%) than in non-responders (58.0% at 3 years; CI 34.0 – 81.3%) (p=0.04; log-rank test). Adverse events were reported in 79.4% of 63 evaluable pts consisting of anaphylaxis/allergy in 27.3%, serum sickness in 12.7%, fever/chills in 34.5%, and bacterial/viral/fungal infections in 54.5% of pts. Conclusion: Response rate and survival after rATG+CsA in this retrospective analysis is lower than in historical controls (e.g. hATG+CsA treatment in previous controlled studies of the German AA Study Group and the EBMT AA Working Party; Frickhofen et al., Blood 2003; Tichelli et al., Blood 2011) and rate of (early) infections seem to be high. Our results are in accordance with recent reports from other groups. Additionally the results of this retrospective data analysis suggest a benefit for the patient group treated with a Thymoglobulin® dosage of > 3.5 –3.75 mg/kg/day compared to lower doses (< 3.5 mg/kg/day). There is growing evidence that best results in terms of response and survival are obtained by hATG-based immunosuppression. hATG can not be replaced by rATG without negative impact on patient outcome. There is need for action to achieve availability of hATG worldwide. If hATG is not available, treatment with rATG should be considered instead of no treatment or treatment with CsA alone since still about half of the patients respond to rATG. Disclosures: Höchsmann: Alexion: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Amgen: Consultancy; Genzyme: Consultancy, Honoraria, Research Funding. Off Label Use: The use of the horse ATG ATGAM in Aplastic Anemia is off-label in Europe. At the moment no horse ATG with approval is available in Europe. Schrezenmeier:Genzyme: Consultancy, Honoraria, Research Funding; Alexion: Consultancy, Honoraria; Novartis: Consultancy, Research Funding.

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Adverse outcomes for missed cases of CDI; results from retrospective data collection on patients with samples received during the European, multi-centre, prospective bi-annual point prevalence study of Clostridium difficile infection in hospitalized patients with diarrhoea (EUCLID2)

10.26226/morressier.56d5ba27d462b80296c95f6e ◽

2016 ◽

Author(s):

Kerrie Davies

Keyword(s):

Clostridium Difficile ◽

Data Collection ◽

Clostridium Difficile Infection ◽

Hospitalized Patients ◽

Adverse Outcomes ◽

Point Prevalence ◽

Prevalence Study ◽

Retrospective Data ◽

Point Prevalence Study ◽

Retrospective Data Collection

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Association between polypharmacy and falls in older adults: a longitudinal study from England

BMJ Open ◽

10.1136/bmjopen-2017-016358 ◽

2017 ◽

Vol 7 (10) ◽

pp. e016358 ◽

Cited By ~ 51

Author(s):

Nafeesa N Dhalwani ◽

Radia Fahami ◽

Harini Sathanapally ◽

Sam Seidu ◽

Melanie J Davies ◽

...

Keyword(s):

Longitudinal Study ◽

Total Population ◽

Incidence Rate Ratio ◽

The Past ◽

Longitudinal Association ◽

Falls In Older Adults ◽

Nationally Representative ◽

English Longitudinal Study ◽

Complex Drug

ObjectivesAssess the longitudinal association between polypharmacy and falls and examine the differences in this association by different thresholds for polypharmacy definitions in a nationally representative sample of adults aged over 60 years from England.DesignLongitudinal cohort study.SettingThe English Longitudinal Study of Ageing waves 6 and 7.Participants5213 adults aged 60 or older.Main outcome measuresRates, incidence rate ratio (IRR) and 95% CI for falls in people with and without polypharmacy.ResultsA total of 5213 participants contributed 10 502 person-years of follow-up, with a median follow-up of 2.02 years (IQR 1.9–2.1 years). Of the 1611 participants with polypharmacy, 569 reported at least one fall within the past 2 years (rate: 175 per 1000 person-years, 95% CI 161 to 190), and of the 3602 participants without polypharmacy 875 reported at least one fall (rate: 121 per 1000 person-years, 95% CI 113 to 129). The rate of falls was 21% higher in people with polypharmacy compared with people without polypharmacy (adjusted IRR 1.21, 95% CI 1.11 to 1.31). Using ≥4 drugs threshold the rate of falls was 18% higher in people with polypharmacy compared with people without (adjusted IRR 1.18, 95% CI 1.08 to 1.28), whereas using ≥10 drugs threshold polypharmacy was associated with a 50% higher rate of falls (adjusted IRR 1.50, 95% CI 1.34 to 1.67).ConclusionsWe found almost one-third of the total population using five or more drugs, which was significantly associated with 21% increased rate of falls over a 2-year period. Further exploration of the effects of these complex drug combinations in the real world with a detailed standardised assessment of polypharmacy is greatly required along with pragmatic studies in primary care, which will help inform whether the threshold for a detailed medication review should be lowered.

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Increased Risk of Severe COVID-19 in Hospitalized Patients With SARS-CoV-2 Variant of Concern Alpha Infection in France: A Multicentre Matched Cohort Study With Retrospective Data Collection

SSRN Electronic Journal ◽

10.2139/ssrn.3866550 ◽

2021 ◽

Author(s):

Guillaume Martin-Blondel ◽

Fraçois-Xavier Lescure ◽

Lambert Assoumou ◽

Charlotte Charpentier ◽

Jean-Marc Chapplain ◽

...

Keyword(s):

Cohort Study ◽

Data Collection ◽

Hospitalized Patients ◽

Retrospective Data ◽

Matched Cohort ◽

Matched Cohort Study ◽

Increased Risk ◽

Retrospective Data Collection

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Tonsillectomy Bleed Rates across the CHEER Practice Research Network

Otolaryngology ◽

10.1177/0194599816630523 ◽

2016 ◽

Vol 155 (1) ◽

pp. 28-32 ◽

Cited By ~ 12

Author(s):

Walter T. Lee ◽

David L. Witsell ◽

Kourosh Parham ◽

Jennifer J. Shin ◽

Nikita Chapurin ◽

...

Keyword(s):

Data Collection ◽

Postoperative Bleeding ◽

Age Groups ◽

Postoperative Hemorrhage ◽

Research Network ◽

Practice Research ◽

Retrospective Data ◽

Significant Difference ◽

Retrospective Data Collection ◽

A Site

Objectives (1) Compare postoperative bleeding in the CHEER network (Creating Healthcare Excellence through Education and Research) among age groups, diagnoses, and practice types. (2) Report the incidence of bleeding by individual CHEER practice site based on practice guidelines. Study Design Retrospective data collection database review of the CHEER network based on ICD-9 and CPT codes related to tonsillectomy patients. Setting Multisite practice–based network. Subjects and Methods A total of 8347 subjects underwent tonsillectomy as determined by procedure code within the retrospective data collection database, and 107 had postoperative hemorrhage. These subjects had demographic information and related diagnoses based on the CPT and ICD-9 codes collected. Postoperative ICD-9 and CPT codes were used to identify patients who also had postoperative bleed. Variables included age (<12 vs ≥12 years), diagnoses (infectious vs noninfectious), and practice type (community vs academic). Statistical analysis included multivariate logistic regression variables predictive of postoperative bleeding, with P < .05 considered significant. Results Thirteen sites contributed data to the study (7 academic, 6 community). There was postoperative bleeding for an overall bleed rate of 1.3%. Patients ≥12 years old had a significantly increased bleed rate when compared with the younger group (odds ratio, 5.98; 95% confidence interval: 3.79-9.44; P < .0001). There was no significant difference in bleed rates when practices or diagnoses were compared. Conclusion A site descriptor database built to expedite clinical research can be used for practice assessment and quality improvement. These data were also useful to identify patient risk factors for posttonsillectomy bleed.

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