Decrease In Proportion Of Patients Research Articles

Characteristics and prognostic factors of bacterial meningitis in the intensive care unit: a prospective nationwide cohort study

BackgroundPatients with bacterial meningitis can be severely ill necessitating intensive care unit (ICU) treatment. Here, we describe clinical features and prognostic factors of adults with bacterial meningitis admitted to the ICU in a nationwide prospective cohort study.MethodsWe prospectively assessed clinical features and outcome of adults (age > 16 years) with community-acquired bacterial meningitis included in the MeninGene study between March 1, 2006 and July 1, 2022, that were initially admitted to the ICU. We identified independent predictors for initial ICU admission and for unfavourable outcome (Glasgow Outcome Scale score between 1–4) by multivariable logistic regression.ResultsA total of 2709 episodes of bacterial meningitis were included, of which 1369 (51%) were initially admitted to the ICU. We observed a decrease in proportion of patients being admitted to the ICU during the Covid-19 pandemic in 2020 (decreased to 39%, p = 0.004). Median age of the 1369 patients initially admitted to the ICU was 61 years (IQR 49–69), and the rates of unfavourable outcome (47%) and mortality (22%) were high. During the Covid-19 pandemic, we observed a trend towards an increase in unfavourable outcome. Prognostic factors predictive for initial ICU admission were younger age, immunocompromised state, male sex, factors associated with pneumococcal meningitis, and those indicative of systemic compromise. Independent predictors for unfavourable outcome in the initial ICU cohort were advanced age, admittance to an academic hospital, cranial nerve palsies or seizures on admission, low leukocyte count in blood, high C-reactive protein in blood, low CSF: blood glucose ratio, listerial meningitis, need for mechanical ventilation, circulatory shock and persistent fever. 204 of 1340 episodes (15%) that were initially not admitted to the ICU were secondarily transferred to the ICU. The rates of unfavourable outcome (66%) and mortality (30%) in this group were high.ConclusionsThe majority of patients with community-acquired bacterial meningitis are admitted to the ICU, and the unfavourable outcome and mortality rates of these patients remain high. Patients that are initially admitted to non-ICU wards but secondarily transferred to the ICU also had very high rates of unfavourable outcome.

Psychophysiological parameters in rosacea patients after complex therapy with Cortexin

Introduction: Taking into account the influence of the psycho-emotional sphere and its disorders on the pathogenetic mechanisms of rosacea, a comparative assessment of the clinical efficacy of a standard therapy and the complex therapy using Cortexin in papulopustular rosacea patients with moderate severity and concomitant neurological pathology was performed. The therapy influence on changes in the patients’ psycho-emotional state was also studied.
 Materials and methods: The study involved 216 papulopustular rosacea outpatients with moderate severity with a concomitant neurological pathology, aged 20 to 60 years. The patients were divided into 2 groups: 109 people (37 men and 72 women) in the study group, and 107 people (37 men and 70 women) in the control. All the patients received a treatment according to the ”Standard of Medical Care for Patients with Rosacea” of the Ministry of Health of the Russian Federation. The study group patients additionally received Cortexin. The study was carried out using the Zung Self-Rating Anxiety Scale (SAS), the Taylor Manifest Anxiety Scale, the Spielberger State-Trait Anxiety Inventory, and the Eysenck Personality Questionnaire.
 Results and discussion: The patients showed an increase in somatic manifestations of anxiety, levels of trait and state anxiety, and neuroticism initially before the start of treatment. The inclusion of Cortexin in the rosacea treatment re­duced the somatic manifestations of anxiety more effectively than standard therapy against the background of a more considerable decrease in proportion of patients with its moderate and high levels. The severity of trait and stateanxiety, neuroticism was also significantly lower against the background of the Cortexin use than with the standard treatment.
 Conclusion: The Cortexin inclusion in the rosacea pharmacotherapy against the background of a concomitant neu­rological pathology contributes to a more pronounced correction of psychophysiological parameters, reflecting the neuroticism levels, trait and state anxiety, and somatic manifestations of anxiety, compared to standard treatment.

Time from admission to surgery in Polish patients with hip fractures: temporal trends in the last decade and association with duration of hospitalization and in-hospital mortality.

Hip fracture is an important cause of morbidity and mortality among elderly patients worldwide. It poses a particular challenge for healthcare systems with limited financial and human resources. The aim of the study was to assess factors associated with the length of hospital stay and in‑hospital mortality, focusing on the time from admission to surgery. The secondary goal was to assess temporal trends in the intervals of admission to surgery between 2010 and 2011 and in 2019. This was a cross‑sectional study enrolling patients aged 65 years or older who underwent surgery for hip fracture between January 2010 and October 2011 in 12 Polish hospitals. Demographic and clinical data, dates of hospital admission and surgery as well as information about in‑hospital death were gathered. We additionally searched the databases of the same 12 hospitals for patients hospitalized due to hip fracture between January and June 2019 and recorded the dates of admission and surgery. We included 381 patients who underwent surgery in 2010 and 2011 and 761 patients hospitalized in 2019. In a multivariable analysis, including age, sex, and diagnosis of dementia, we observed association between time from admission to surgery and higher in‑hospital mortality and longer hospital stay. There was a decrease in proportion of patients undergoing surgery within 2 days from admission (52.8% vs 44.3%; P = 0.007) between 2010 to 2011 and in 2019. In‑hospital mortality and length of hospitalization were associated with time from admission to surgery in patients undergoing surgery for hip fracture. We observed an alarming trend towards an increase in the admission-surgery interval.

Trends in Inpatient and Intensive Care Resource Utilization after Chimeric Antigen Receptor T Cell Therapy for Pediatric Acute Lymphoblastic Leukemia from 2012-2019

Background: CD19-targeted chimeric antigen receptor T cell therapy (CART19) has demonstrated remarkable clinical efficacy in treating relapsed/refractory B cell ALL, but associated toxicities may require treatment in inpatient or intensive care units (ICU). We sought to: (1) describe inpatient and ICU resource utilization within 30 days of CART19 infusion; and (2) evaluate trends in resource utilization from 2012-2019. Methods: We identified patients treated with CART19 on a clinical trial (NCT01626495, NCT02906371, and NCT02374333) or with the commercial product, tisagenlecleucel, at Children's Hospital of Philadelphia. Patients who received a prior cell therapy product were excluded. Demographic, pharmacy, and inpatient data were extracted from the electronic medical record from day of infusion (day 0) to day +30, censored at disease progression or death, using a semi-automated EPIC data query tool (ExtractEHR). The Virtual Pediatric Systems (VPS) database was queried for clinical data, resource utilization data, and Pediatric Risk of Mortality (PRISM) 3 and Pediatric Index of Mortality (PIM) 2 severity of illness scores. Log-binomial regression and linear regression were used to estimate the association of patient characteristics with the need for inpatient/ICU admission and inpatient/ICU length of stay (LOS), respectively. Similar models were used to estimate trends in outcomes from 2012-2019. Results: A total of 213 patients were included in the analyses. Median patient age was 12.4 years (range 1.4-29.1) at infusion; 60% were male, 66% were Caucasian, and 80% were non-Hispanic. Prior to CART19, 42% had an allogeneic hematopoietic cell transplant (alloHCT). At time of infusion, 19% had high disease burden, defined as bone marrow blasts ≥40% by flow cytometry. From 2012-2019, the proportion of patients with prior alloHCT or high disease burden decreased (Table 1). CART19 was infused in the outpatient setting in 93% of patients. In the 30 days after infusion, 70% had at least one inpatient admission, starting at a median of day +2 (IQR +1 to +6). Among the 149 patients admitted, median cumulative inpatient LOS was 7 days (IQR 4-13). Cumulative LOS increased with increasing grade of cytokine release syndrome (CRS). Median LOS was 0, 5, and 15 days for patients with no, mild, and severe CRS, respectively. From 2012-2019, there were linear trends toward decreases in proportion of patients admitted (p<.0001) and in cumulative inpatient LOS (p=0.001, Figure 1), which remained significant after adjustment for disease burden (p=0.032 and p<.0001). ICU admission was required for 23% (95% CI, 17-29) of the cohort, starting at a median of day +5 (IQR +4 to +6.5). ICU admission was more frequent for patients with high disease burden than those with low disease burden [68% (95% CI, 52-81) vs. 11% (95% CI, 7-17), p<.0001]. Among the 48 patients admitted to the ICU, resources utilized included vasoactive agents (n=36, 75%), non-invasive or invasive mechanical ventilation (n=24, 50%), and renal replacement therapy (RRT; n=4, 8%). In the 30-day follow-up period, median ICU LOS was 7 days (IQR 3-11.5), but 6 (12.5%) patients remained in the ICU after day +30. Among patients who required vasoactives, invasive mechanical ventilation, or RRT, the median duration of resource utilization was 5, 7.2, and 2 days, respectively. Seventy five percent (n=36) of patients admitted to the ICU received tocilizumab. Predicted median risk of mortality was 6.02% (IQR 5.04-7.32%) by PIM 2 and 10.74% (IQR 6.78-27.08%) by PRISM 3 scores. However, observed 30-day mortality was 1% (n=2) across the cohort, or 4% among ICU patients. From 2012-2019, there was a decrease in proportion of patients requiring ICU admission (p=0.001), but no significant changes in cumulative ICU LOS (Figure 1). Other than high disease burden, baseline patient characteristics were not significantly associated with inpatient/ICU admission or inpatient/ICU LOS. Conclusion: In a cohort of 213 pediatric patients with ALL who received CART19, over 90% were safely infused in the outpatient setting. Though the majority of patients required at least one inpatient admission, the proportion of patients admitted to the hospital or ICU and cumulative inpatient LOS in the 30 days post-infusion decreased over the past 7 years. Mortality was 1%. Additional analyses will investigate the impact of changes in supportive care practices on resource utilization outcomes. Disclosures Grupp: GSK: Consultancy; Cure Genetics: Consultancy; Humanigen: Consultancy; CBMG: Consultancy; Novartis: Research Funding; Kite: Research Funding; Novartis: Consultancy, Research Funding; Roche: Consultancy; Servier: Research Funding; Jazz: Other: study steering committees or scientific advisory boards; Adaptimmune: Other: study steering committees or scientific advisory boards. Maude:Novartis: Consultancy; Kite: Consultancy.

Impact of a homeopathic medication on upper respiratory tract infections in COPD patients: Results of an observational, prospective study (EPOXILO).

Chronic obstructive pulmonary disease (COPD) is a progressive lung disorder in which airflow is obstructed. Viral or bacterial upper respiratory tract infections (URTIs) may lead to exacerbations. Homeopathic medication administration to COPD patients during the influenza-exposure period may help to reduce the frequency of common URTIs. This prospective, observational, multicenter study was carried out in Cantabria, Spain. Patients with COPD were divided into two groups: group 1 received conventional treatment+homeopathic medication (diluted and dynamized extract of duck liver and heart; Boiron) (OG); group 2 received conventional treatment only (CG). The primary endpoint was the number of URTIs between the 4-5 months follow up (mean 4.72±0.96) from basal to last visit. Secondary endpoints included the duration of URTIs, number and duration of COPD exacerbations, use of COPD drugs, changes in quality of life (QoL), compliance, and adverse events (AEs). 219 patients were analyzed (OG = 109, CG = 110). There was a significant reduction in mean number of URTIs during the follow-up period in OG compared to CG (0.514 ± 0.722 vs. 1.037 ± 1.519, respectively; p = 0.014). Logistic regression analysis showed a 3.3-times higher probability of suffering ≥2 URTI episodes in CG (p = 0.003, n = 72). OG patients having ≥1 URTI also had a significant reduction in mean URTI duration per episode (3.57 ± 2.44 days OG vs. 5.22 ± 4.17 days CG; p = 0.012). There was no significant difference in mean number of exacerbations, mean duration of exacerbations, or QoL between OG and CG. There was a greater decrease in proportion of patients using corticosteroids for exacerbations between baseline and visit 2 in OG compared to CG (22.1% vs. 7.5% fewer respectively, p = 0.005). Exacerbator phenotype patients had a significant decrease in number of URTIs (0.54 ± 0.72 vs. 1.31 ± 1.81; p = 0.011), and fewer COPD exacerbations (0.9 ± 1.3 vs. 1.5 ± 1.7; p = 0.037) in OG vs. CG, respectively. Homeopathic medication use during the influenza-exposure period may have a beneficial impact at reducing URTIs' number and duration in COPD patients and at reducing the number of COPD exacerbations in patients with the exacerbator phenotype. Further studies are needed to confirm the effects observed in this study.

RA06.07: PSYLLIUM SUPPLEMENTATION EFFECT ON ESOPHAGEAL FUNCTION TESTING AND SYMPTOMS IN PATIENTS WITH NON-EROSIVE GERD

Abstract Background Epidemiological data showed negative correlation between heartburn frequency and amount of dietary fiber consumed. However no interventional study was performed to prove clinically beneficial effect of dietary fibers in gastroesophageal reflux disease (GERD) patients. The aim of the study was to investigate the effect of dietary fiber on symptoms and esophageal function testing parameters in non-erosive GERD patients (NCT01882088) Methods Thirty six NERD patients were examined using food frequency questionnaire and in case of less than 20 g/day dietary fibre intake underwent high-resolution esophageal manometry and 24-hours esophageal pH-impedance. Language-specific GERD-Q questionnaire was used to assess symptoms. Repeated examinations were performed after 10 days of usual diet supplemented by psyllium 15.0 gram a day. Complete data of 30 NERD patients were available for the final analysis. Study design is shown in a figure 1. Wilcoxon matched pairs test was used to assess changes in the studied parameters Results The decrease in proportion of patients experiencing heartburn as well as GERD-Q score decrease were found. Minimal resting lower esophageal sphincter pressure increased from 5.41 ± 10.1 to 11.3 ± 9.4, P = 0.023. No change in residual LES pressure and mean resting pressure was found. Total number of gastroesophageal refluxes decreased from 67.9 ± 17.7 to 42.4 ± 13.5, P < 0.001 (Table 1). Conclusion Supplementation of diet with psyllium 5.0 gram TID in NERD patients led to significant increase of minimal esophageal resting pressure, decrease of number of gastroesophageal refluxes and frequency of heartburn per week. The work was supported by Federal Agency of Scientific Organizations of Russia (0529–2017-0057) Disclosure All authors have declared no conflicts of interest.

Preliminary effects of a regional approached multidisciplinary educational program on healthcare utilization in patients with hip or knee osteoarthritis: an observational study

BackgroundProviding relevant information on disease and self-management helps patients to seek timely contact with care providers and become actively involved in their own care process. Therefore, health professionals from primary care, multiple hospitals and health organisations jointly decided to develop an educational program on osteoarthritis (OA). The objective of the present study was to determine preliminary effects of this OA educational program on healthcare utilization and clinical outcomes.MethodsWe developed an educational group-based program consisting of 2 meetings of 1.5 h, provided by a physiotherapist, a general practitioner (GP) and orthopaedic surgeon or specialized nurse. The program included education on OA, (expectations regarding) treatment options and self-management. Patients were recruited through searching the GPs’ electronic patients records and advertisements in local newspapers. At baseline and at 3 months follow-up participating OA patients completed questionnaires. Paired-sample t-tests, McNemar’s test and Wilcoxon Signed-Rank test were used to estimate the preliminary effects of the program.ResultsA total of 146 participants in 3 districts attended the sessions, of whom 143 agreed to participate in this study; mean age 69.1 years (SD10.2).107 (75%) participants completed both baseline and follow up assessments. The proportion of participants who had visited their GP in the 3 months after the program was lower than 3 months previous to the program (40% versus 25%, p-value 0.01). Also, we observed a decrease in proportion of patients who visited the physio- and exercise therapist, (36.1% versus 25.0%, p-value 0.02). Both illness perceptions and knowledge on OA and treatment options changed positively (Δ-1.8, 95%CI:0.4–3.4, and Δ2.4, 95%CI:-3.0 - -1.6 respectively). No changes in BMI, pain, functioning and self-efficacy were found. However, a trend towards an increase in physical activity was observed.ConclusionsOur results show that a multidisciplinary educational program may result in a decrease in healthcare utilization and has a positive effect on illness perceptions and knowledge on OA due to clear and consistent information on OA and it treatment options.Trial registrationNetherlands Trial Register (NTR5472). Registered 22 September 2015.

Associations of Emergency Department Length of Stay With Publicly Reported Quality-of-care Measures.

The Institute of Medicine identified emergency department (ED) crowding as a critical threat to patient safety. We assess the association between changes in publicly reported ED length of stay (LOS) and changes in quality-of-care measures in a national cohort of hospitals. Longitudinal analysis of 2012 and 2013 data from the American Hospital Association (AHA) Survey, Center for Medicare and Medicaid Services (CMS) Cost Reports, and CMS Hospital Compare. We included hospitals reporting Hospital Compare timeliness measure of LOS for admitted patients. We used AHA and CMS data to incorporate hospital predictors of interest. We used the method of first differences to test for relationships in the change over time between timeliness measures and six hospital-level measures. The cohort consisted of 2,619 hospitals. Each additional hour of ED LOS was associated with a 0.7% decrease in proportion of patients giving a top satisfaction rating, a 0.7% decrease in proportion of patients who would "definitely recommend" the hospital, and a 6-minute increase in time to pain management for long bone fracture (p<0.01 for all). A 1-hour increase in ED LOS is associated with a 44% increase in the odds of having an increase in left without being seen (95% confidence interval=25% to 68%). ED LOS was not associated with hospital readmissions (p=0.14) or time to percutaneous coronary intervention (p=0.14). In this longitudinal study of hospitals across the United States, improvements in ED timeliness measures are associated with improvements in the patient experience.

Methotrexate Efficacy in the Tight Control in Psoriatic Arthritis Study.

Methotrexate (MTX) is a commonly used disease-modifying antirheumatic drug in psoriatic arthritis, but there is conflicting evidence to support its efficacy. Within the Tight Control of Psoriatic Arthritis (TICOPA) study, patients were treated with MTX as part of the tight control protocol or standard care. Outcomes were recorded at the 12-week visit, including joint counts, skin, nail, enthesitis, dactylitis, and patient-reported measures. Of the 206 patients enrolled, 188 received MTX in the first 12 weeks of the trial with 104 receiving a mean dose > 15 mg/week. The proportions of patients achieving the American College of Rheumatology (ACR) outcomes at 12 weeks were ACR20 40.8%, ACR50 18.8%, and ACR70 8.6%, with 22.4% achieving minimal disease activity. Improvements were seen in psoriasis with 27.2% reaching a Psoriasis Area and Severity Index (PASI) 75. The proportion of patients with dactylitis and Leeds dactylitis instrument (LDI) scores decreased significantly (62.7% decrease in patients with dactylitis, median change LDI -59.7, -157.4 to -26.4, p = 0.033). The decrease in proportion of patients with enthesitis (25.7%) was significant, but the median change in enthesitis score was 0. There was a trend to higher proportions of patients receiving over 15 mg/week achieving ACR20, ACR50, and PASI75. Despite the open-label design of the data, improvements in multiple clinical outcomes were seen. The proportion of patients reaching ACR20 in the TICOPA study was higher than in the Methotrexate in Psoriatic Arthritis study (41% vs 34%), but no comparative data are available for other outcomes. There is a suggestion of a dose response, but this is hard to assess when patients doing well may be maintained on lower doses.

Slow Deadoptation of a Strategy: Was Tight Glycemic Control Truly Impractical?

Hyperglycemia is a prevalent scenario in critically ill patients. Hyperglycemia is associated with many adverse outcomes, including immune disorder, oxidative stress, susceptibility to infection, and endothelial dysfunction. Its impact is believed to be independently associated with increased mortality because it enhances the inflammatory responses. Some randomized controlled clinical trials have attempted to determine whether intensive insulin therapy targeted on establishing normoglycemia could benefit septic patients. Initial studies of adjustable insulin infusions to decrease blood glucose levels raised interest in inpatient glycemic control strategies (1,2), and several organizations called for implementing intensive insulin therapy (IIT) strategies using adjustable insulin infusions titrated to strict glycemic targets in the intensive care unit. Despite the early evidence of benefit from IIT (3-6), many subsequent trials, including the largest IIT trial to date, have not found a consistent benefit (7). Niven et al., in their article (8), evaluated glycemic control in critically ill patients before and after the publication of clinical trials, highlighting the fact that it was initially suggested that tight glycemic control reduced mortality (i.e. LEUVEN I study(6)), but subsequently it was suggested that tight glycemic control increased mortality (i.e. NICE SUGAR trial (7)). Before the publication of Leuven I, 17.2% (95% CI, 16.2%-18.2%) of ICU admissions had tight glycemic control, 3.0% (95% CI, 2.6%-3.5%) had hypoglycemia, and 40.2% (95% CI, 38.8%-41.5%) had hyperglycemia. After the publication of Leuven I, there were significant increases in the relative proportion of admissions with tight glycemic control (1.7% per quarter; 95% CI, 1.2%-2.3%; P < .001) and hypoglycemia (2.5% per quarter; 95% CI, 1.9%-3.2%; P <0.001) and decreases in those with hyperglycemia (0.6% per quarter; 95% CI, 0.4%-0.9%; P <0.001). Following the publication of NICE-SUGAR, there was no change in the proportion of patients with tight glycemic control or hyperglycemia. There was an immediate decrease in the relative proportion of patients with hypoglycemia (22.4%; 95% CI, 13.2%-30.1%; P <0.001) but no subsequent change over time. The authors reported that little or no deadoption from tight glycemic control was achieved following NICE SUGAR trial (1). It should be considered that there are fundamental differences between LEUVEN and NICE SUGAR trials. First, the level of therapy compliance in LEUVEN study was 70% compared to less than 50% in NICE SUGAR trial. Unsurprisingly, studies having managed to adequately achieve the blood glucose target have been associated with a reduced mortality compared to those not succeeding in therapy compliance. Second, in NICE SUGAR study, a variety of sampling sites and glucose meters were allowed most of which have recently been shown to be unsuitable for this purpose. Third, feeding strategies differed in two studies; in NICE SUGAR study feeding relied almost exclusively on the enteral route whereas in LEUVEN study, most of patients received supplemental parenteral nutrition which could be directed to a better response to insulin therapy. Fourth, most of the studied subjects in NICE SUGAR study were medical patients whereas in LEUVEN study, most of the studied subjects were surgical patients; these two different target groups would have had different responses to insulin therapy. Finally, normoglycemia was compared with distinctly different control targets (10-12 mmol/l in LEUVEN vs. 8-10 mmol/l in NICE SUGAR studies) which would have led to completely different results. As can be observed, there are numerous fundamental differences between these two studies which could have contributed to different outcomes. These obvious differences would definitely contribute to the unwillingness of the physicians for deadoption from tight glycemic control protocol. Further trials are required to evaluate this complex intervention which is occasionally incompletely implemented in recent trials.

Saquinavir/r containing initial antiretroviral therapy (ART)-long term evaluation in Polish Observational Cohort of HIV/AIDS Patients (POLCA) Study Group

BackgroundSince the introduction of highly active antiretroviral treatment significant decrease of HIV related morbidity and mortality has been noted. Ritonavir boosted saquinavir is an alternatively recommended protease inhibitor. Therefore we evaluated log term efficacy and safety of saquinavir/r (SQV/r) containing initial antiretroviral regimen on the basis of Polish Observational Cohort of HIV/AIDS Patients (POLCA).Materials and Methods The analysed data were prospectively collected in routine clinical practice and included ART naive patients starting SQV/r regiment as their first ART. ResultsFrom among 259 naive patients, who started SQV/r containing regimen 56.1% continued it for 24 months. Majority of the patients were male (74.9%). Similar proportion of patients was infected by IVDU (40.1%) and by sexual contact (47.1%). Median time from initial diagnosis was 2.16 years. Median baseline lymphocytes count was 210cells/mm3.Viral failure defined as HIV RNA>200copies/ml in at least two consecutive tests or>500copies/ml in one test was observed in 30 patients (11.5%). Analysing treatment related toxicities we found gradual decrease in proportion of patients with proteinuria (44.4–26%). Proportion of patients with normal total cholesterol, LDL and triglycerides decreased after 6 months of treatment and remained stable, whereas proportion of patients with normal HDL increased gradually to the end of observation. 23% of patients discontinued SQV/r containing regimen due to side effects, mainly gastrointestinal. ConclusionsSaquinavir/r containing regimen remains a valuable and safe option for patients with indications to protease inhibitor based antiretroviral treatment.

China rubra for side-effects of quinine: a prospective, randomised study in pregnant women with malaria in Cotonou, Benin

In endemic areas, gestational malaria is responsible for low birth weight and maternal anaemia. Quinine is the reference treatment for acute malaria in pregnant women, irrespective of term. However, quinine administration is associated with various side-effects. We evaluated the impact of the homeopathic medicine China rubra 7CH on the side-effects of quinine used as treatment for acute malaria in pregnant women in Cotonou, Benin. This prospective, comparative, randomised study was carried out between June and December 2007 in the Saint Jean-Baptiste Medical Centre, Cotonou. Women were included if they were >3 months pregnant and had a clinical diagnosis of malaria confirmed by a positive thick blood smear. The study population was divided into two groups: (i) patients who presented between the 1st and 15th of each month and who received China rubra 7CH plus quinine (China group); and (ii) patients who presented from the 16th to the end of each month and who received treatment with quinine only (Standard group). The aim was to compare the frequency of side-effects of quinine in the two groups until day 6 after the start of treatment. Neither the patients nor the care givers were blinded to study treatment. Statistical comparison of the two groups was carried out with an alpha risk fixed at 5%. 211 women were recruited: 105 received quinine plus China rubra 7CH (China group) and 106 received quinine only (Standard group). A decrease in proportion of patients presenting with side-effects was observed in the China group from day 0 to day 6 of follow-up (53.9%-23.3%) whereas the proportion of patients with side-effects in the Standard group did not change significantly (85.9% on day 0 vs. 82.5% on day 6). Ninety-six (72.4%) patients in the China group and 103 (97.2%) in the Standard group reported at least one side-effect during follow-up (p < 0.0001). The most frequently reported side-effects were tinnitus, dizziness and asthenia. This preliminary study shows the interest of China rubra 7CH in limiting the side-effects of quinine used for the treatment of acute malaria in pregnant women.

Implementation of Computerized Physician Order Entry for Critical Patients in an Academic Emergency Department is Not Associated with a Change in Mortality Rate.

Introduction:There is limited literature on the effect of computerized physician order entry (CPOE) on mortality. The objective of our study was to determine if there was a change in mortality among critically ill patients presenting to the emergency department (ED) after the implementation of a CPOE system.Methods:This was a retrospective study of all critically ill patients in the ED during the year before and the year after CPOE implementation. The primary outcome measures were mortality in the ED, after admission, and overall. Secondary outcome measures included length of stay in the resuscitation area of the ED, length of hospital stay, and disposition following hospitalization. Patient disposition was used as a marker for neurologic function, and patients were grouped as either being discharged to home vs. nursing home, rehabilitation center, or a long-term healthcare facility. We analyzed data using descriptive statistics, chi- square, and Wilcoxon rank sum tests.Results:There were 2,974 critically ill patients in the year preceding CPOE and 2,969 patients in the year following CPOE implementation. There were no differences in mortality between the two groups in the ED, after admission, or overall. The pre- and post-CPOE mortality rate for the ED, hospital, or overall was 2.52% vs. 2.02% (P = 0.19, 95% confidence interval [CI] −0.3 to 1.3), 7.8% versus 8.29% (P = 0.61, 95% CI −1.9 to 0.9), and 10.32% vs. 10.31% (P = .60, 95% CI −1.5 to 1.6), respectively. There was no difference in hospital length of stay between pre- and post-CPOE patients (3 days versus 3 days), a difference of 0.05 days (95% CI −0.47 to 0.57). Length of stay in the ED resuscitation area was longer in the post-CPOE group (31 versus 32 minutes), a difference of −1.96 minutes (95% CI −3.4 to −0.53). More patients were discharged to home in the pre-CPOE group (66.8% versus 64.3%), a difference of 2.54% (95% CI 0.13% to 4.96%).Conclusion:The implementation of CPOE was not associated with a change in mortality of critically ill ED patients, but was associated with a decrease in proportion of patients discharged to home after hospitalization.

Correlation of CA-125 and RECIST evaluation in recurrent ovarian cancer (ROC): Results from a randomized phase III study of trabectedin (T) with pegylated liposomal doxorubicin (PLD) versus PLD alone

5550 Background: OVA-301, an open-label, multicenter, randomized phase III study comparing the combination of T and PLD to PLD alone in 672 ovarian cancer patients, showed significant prolongation in Progression-Free Survival (PFS) and higher Objective Response (OR) in the combination arm (T-PLD) by three separate assessments, investigator assessment (IA), independent radiology (IR) and oncology review (IO). The purpose of this analysis is to examine: 1) the impact of early changes in CA-125 over the subsequent best OR by RECIST; 2) the concordance between best OR determined by CA-125 and RECIST; 3) the value of CA-125 to predict radiological response. Methods: Tumor assessments by imaging and CA-125 were performed at baseline, and every 8 weeks during study in both arms. Radiological tumor assessment, regardless of CA-125 changes, determined the study conduct. Early CA-125 changes were those assessed at the first and second evaluation. Analyses were based on “all randomized patients.” Results: Response rate by RECIST (IR)/CA-125 was 28%/48% for T-PLD vs. 19%/33% for PLD. The association between CA-125 and RECIST response was stronger for IA relative to IR/IO, with 79% concordance for both arms, 65% overall positive predictive value (PPV) and 89% negative predictive value (NPV) for IA and 74%/75% concordance, 46%/49% PPV and 93%/92% NPV for IR/IO. Early CA-125 changes were assessed in 514 patients. Early ≥25% CA-125 decreases in the first/second evaluation occurred in 85%/95% of RECIST responders in the T-PLD arm and in 81/82% responders treated with PLD. Conclusions: The predictive value of CA-125 response was high and similar in both arms. The addition of T to PLD resulted in superior efficacy in this patient population as assessed by IA, IR and IO, with a favorable trend for CA-125 response assessment. RECIST response was preceded by a significant CA-125 decrease in a high proportion of patients. [Table: see text]

Experimental Evaluation of the Effects of Drug Information on Antibiotic Prescribing: A Study in Outpatient Care in an Area of Sri Lanka

The intervention level of epidemiology is useful for studying effects in health systems research. Due to practical and ethical reasons, it is often difficult to apply experimental methods such as classical randomized clinical trials in the field. However with alternative approaches such as 'randomization by group' some of these problems can be overcome. Drug information has since long been considered as an instrument to influence physicians, however evaluation of its effects is a new field of research. In the present study the impact of drug information on prescribing behaviour was evaluated in an outpatient setting in Sri Lanka. The study included 15 state health institutions (45 prescribers) with a common drug formulary. Groups of prescribers were randomized into two interventions; newsletters and newsletters reinforced by a group seminar, and one control group. The target topic was 'rational prescribing of antibiotics'. Some 18,766 randomly selected outpatient drug prescriptions were studied. Antibiotics (and sulphonamides) were prescribed to 33.2% of the patients. An overall trend towards a decrease in proportion of patients prescribed antibiotics in the two intervention groups was seen, although the difference was not significant (p greater than 0.05) compared to the control group. This is similar to the effect of written information on prescribing in other studies. A mean difference of -7.4% in written, -7.3% in written + seminar and -0.4% in the control group was shown. The general antibiotic prescribing pattern did not change in any of the three groups. Penicillin was the most commonly prescribed antibiotic and tetracycline was only rarely prescribed to children. This experiment indicates the feasibility of drug information intervention studies in developing countries.(ABSTRACT TRUNCATED AT 250 WORDS)