Difference In Distribution Of Patients Research Articles

THE IMPACT OF INTERMEDIATE TITER ANTIBODIES TO ADALIMUMAB (ATA) AND INFLIXIMAB (ATI) ON CLINICAL OUTCOMES IN PATIENTS WITH CROHN’S DISEASE (CD) OR ULCERATIVE COLITIS (UC)

Abstract Background Anti-TNF drugs, adalimumab (ADA) and infliximab (IFX), are effective treatments for ulcerative colitis (UC) and Crohn’s disease (CD). However, 30% of patients do not respond to treatment (primary non-response) and 40% lose response over time (loss of response). Loss of response is often due to development of antibodies to ADA (ATA) and IFX (ATI). While it is known that undetectable or low ATA/ATI titers (<200 ng/mL) are associated with better outcomes and high ATA/ATI titers (>1000 ng/mL) are associated with poor outcomes, the significance of intermediate ATA/ATI titers (200–999 ng/mL) is not well understood. This study aims to investigate the impact of intermediate ATA/ATI titers on outcomes in CD and UC patients. Methods A retrospective chart review was conducted on CD and UC patients to determine associations between intermediate ATA/ATI titers and adverse clinical outcomes. The primary clinical outcome of interest is persistence on anti-TNF therapy 1 year after measurement of ATA/ATI titers. Secondary clinical outcomes of interest include clinical response to therapy 1 year after measurement of ATA/ATI titers. Participants consist of UC or CD patients treated with IFX or ADA at the University of Maryland IBD Program between October 2016 and October 2019 that had at least one measurement of ADA/ IFX and ATA/ATI during the study period. Results 376 patients were identified (ADA=157 and IFX=219). 271 of 322 low titer patients persisted on their original anti-TNF compared to 9 of 15 intermediate titer patients (p=0.026) and 1 of 10 high titer patients (p<0.0001) (Table 1). The odds ratio (OR) of persistence comparing intermediate titer to low was 0.26 (0.09 to 0.80) and comparing high titer to low was 0.02 (0.00 to 0.14). In the low titer group, 47, 33, and 251 of 331 patients had no, partial, or complete response to therapy, respectively. In the intermediate titer group: 6, 1, and 8 of 15 patients, had no, partial or complete response; in the high titer group: 3, 1, and 3 of 10 patients, had no, partial, or complete response (Table 2). The difference in distribution of patients who showed no, partial, and complete response was significantly different between low titer patients and intermediate titer patients (p=0.019), but not different between intermediate titer and high titer patients (p=0.440). Conclusion Patients with intermediate titers were more likely than patients with low titers to lose response to anti-TNF and require a change anti-TNF therapy. Although our sample size of patients with intermediate titers was small, providers should consider dose optimization of anti-TNF with or without addition of an immune suppressant when intermediate titers are present. An alternative approach would be to repeat drug and antidrug antibody levels to assess for worsening pharmacokinetics. Persistence on original anti-TNF 1 year after first measurement in low, intermediate, and high titer patients (Fisher’s test). Response to therapy 1 year after first measurement in low, intermediate, and high titer patients (Fisher’s test).

Ginger Relief Chemotherapy Induced Nausea and Vomiting (CINV) in Children: A Randomized Clinical Trial

Background One of the major adverse effects of chemotherapy is chemotherapy induced nausea and vomiting (CINV) which can obviously reduce patients’ quality of life. Ginger (Zingiber officinale), an herbal supplement, has been used for centuries for gastrointestinal complaints. Although many surveys have been conducted to find the efficiency of ginger on CINV, its benefit has not been proven yet. We aimed to find ginger’s efficiency on pediatric patients throughout their chemotherapy cycles. Materials and Methods: This was a double-blinded, randomized, single institutional, placebo-controlled trial conducted at oncology ward in Aliasghar children’s hospital, Tehran, Iran. The study took place between October 2017 and October 2018. We included 49 chemotherapy cycles, 25 cycles for treatment group and 24 cycles for placebo groups. Intervention group took encapsulated ginger which contained 240mg of powdered ginger (Nausophar), and control group took placebo. All patients took the study medication four times per day (every 6h), starting on the first day of chemotherapy until 24h after completion of chemotherapy. Frequency and severity of nausea and vomiting were measured by Edmonton’s Symptom Assessment Scale (ESAS) from the first day of chemotherapy until 24h after completion of chemotherapy. Results: The median age of all participants was 13 (IQR=8-14 year-old). Fourteen patients were male (28.6%), and 35 patients were female (71.4%). There were no significant differences in distribution of patients’ characteristics in two groups. The frequency and severity of nausea and vomiting were significantly lower in ginger group (p <0.05). Conclusion According to our findings, ginger acts as an efficient antiemetic for pediatric patients. We recommend that ginger be prescribed as well as other antiemetics like Granisetron, with no loss of function.

Comparison of Preoperative Ultrasound Report with Intraoperative Findings of Laparoscopic Cholecystectomy in Gallstone Disease in Al-Diwaniyah Teaching Hospital

Background: Gallstones constitute a significant health problem in developed societies, affecting 10% to 15% of the adult population, meaning 20 to 25 million Americans have (or will have) gallstones. The resultant direct and indirect cost of gallbladder disease represents a consumption of ~$6.2 billion annually in the U.S., constituting a major health burden that has increased more than 20% over the last 3 decades. The best diagnostic tool is ultrasound; however, several authosr have raised the issue of inconsistency between preoperative ultrasound evaluation and laparoscopic operative findings.Aim of the study: To compare preoperative ultrasound findings with operative findings in patients undergoing laparoscopic cholecystectomy in order to evaluate the accuracy of ultrasound in detecting gallbladder pathology.Patients and Method: In this hospital based study, in order to evaluate the concordance and discrepancy between preoperative ultrasound findings and operative findings in patients subjected to laparoscopic cholecystectomy. At the end of study we were able to include 100 cases. The study started on January the 2nd 2019 and ended at June the 15th 2019. The study was carried out at laparoscopic unit in Al-Diwaniyah teaching hospital. Ultrasound findings were retrieved from available reports that are already kept with the case file sheet of each patient. Operative findings were obtained the surgery team and by the use of a special device which provide information about size of stone and gallbladder wall thickness.Results: Regarding number of stones and for purpose of unification both ultrasound sound findings and operative findings were contrasted as single stone versus multiple stones, as shown in table 2. Indeed, there was almost complete agreement between ultrasound and operative findings since 22 patients were diagnosed as having single stone by both methods and 76 were diagnosed as having multiple stones by both methods. According to MeNemar test, there was no significant difference in distribution of patients into having single versus multiple stones (P = 1.000), a finding that was further supported by Kappa agreement statistic of 0.944 (P < 0.001), table 4.3.

Comparative study of conventional and topical heparin treatment in second degree burn patients for burn analgesia and wound healing

ObjectiveTo compare clinical outcome of topical conventional with topical heparin treatment in 2nd degree or partial thickness (PTB) burn patients. MethodsPatients, between the ages of 14 and 60 years with 2nd degree burns involving <20%. Total body surface area (TBSA) on front of chest, abdomen and upper limbs excluding hands and lower limbs were enrolled from September 2015 to August 2016. Patients were randomized to conventional or heparin treatment groups. Clinical outcome measured were healed wound size, pain scores and total consumption of analgesic medication required to relieve pain. Safety of the treatment and adverse events were also measured ResultsOut of 66 patient included in study mean (SD) age of participants was 27 (10) years, of which 59% were males. Mean (SD) TBSA burn was 14% (3) [23 (35%) had SPTB, and 43 (65%) had DPTB]. The burn injury was caused by flames in 68% and by hot liquids in 32% patients. There was no statistically significant difference in distribution of patients according to age, gender, TBSA burn, etiology or depth of burns in the two treatment groups. As compared to conventional treatment group, heparin treatment group had significantly better outcomes. Number of days needed for wound healing was significantly lower in the heparin group than the conventional group (SPTB 14±1 vs. 20±4 days; P-value <0.000 and for DPTB, 15±3 vs. 19±2 days; P-value <0.003). Mean pain score was also lower in the heparin group (for both SPTB and DPTB 3±1 vs. 7±1; P-value <0.000). Similarly, total consumption of analgesic medication was significantly less in the heparin group (53±27 vs. 119±15mg; P-value <0.000 for SPTB and 46±6 vs. 126±12mg; P-value <0.000 for DPTB). In both groups, no patient had wound infection, skin necrosis, leucopenia, thrombocytopenia, worsening renal function, or abnormal liver enzymes ConclusionTreatment of second degree or partial thickness burns (PTB) with topical heparin is superior to conventional treatment in terms of wound healing as well as for pain control. The treatment with topical heparin is well-tolerated and is without higher adverse effects.

A Comparison of Incremental Costs of Breast Cancer Clinical Trials to Standard of Care

Objective: Clinical trials are an essential element in the improvement of cancer prevention and treatment strategies. A widely held perception is that costs of care for clinical trial (CT) patients are higher than standard of care (SOC). There is a paucity of data supporting this assertion. The objective of this study was to determine the costs of breast cancer patients enrolled on a clinical trial compared to eligible patients who did not participate in a trial. Methods: A retrospective cohort study was conducted to compare costs incurred by 97 breast cancer patients participating in a mix of industry and non-industry sponsored clinical trials with those costs incurred by 97 eligible nonparticipants who received SOC. Resource utilization was tracked for one year and quantified to standardized price templates. Seven cost variables were examined: physician time, nursing time, tests and procedures, diagnostic imaging, pathology, radiation therapy, and pharmaceuticals. Results: Mean costs were marginally higher for the CT patients than the SOC patients for all seven cost variables, as were the mean total costs ($16,418 versus 10,002, p-value=0.046). Pharmacy costs constituted the largest difference between the trial and SOC patients (mean difference=$5,157, p=0.08). After excluding all drugs that were provided by the study sponsors at no charge, the remaining average pharmacy costs were more equal between groups (mean difference=$990, p=0.45). As a result, the mean difference between the total costs of the two groups was reduced by two-thirds, from $6,396 to $,227 and statistical significance was lost (p=0.14). Conclusions: This study revealed only minor differences in the cost distribution of patients enrolled in CT versus those receiving SOC. This is similar to results previously seen for prostate cancer patients.

Disability and mood state in patients with episodic and chronic migraine associated to medication overuse

This study aims to compare disability and mood state in patients with episodic (EM) and chronic migraine associated to medication overuse (CM-MO), and to assess the relationships between the two outcomes. Patients, matched for age and gender, were administered the MIDAS, the WHO-DAS-2 and BDI-2. Difference between EM and CM-MO was assessed with the Kolmogorov-Smirnov Test; difference in distribution of patients with severe disability and low mood was tested with contingency coefficient; the correlation between MIDAS, WHO-DAS-2 and BDI-2 was tested with Spearman's index. Seventy patients were enrolled: CM-MO patients reported higher BDI-2 scores and higher MIDAS and WHO-DAS-2 scores, and were more likely to have severe disability and low mood state than those with EM; BDI-2 scores were correlated with disability scores, particularly with WHO-DAS-2. The study shows that disability and mood state are negatively impacted by the presence of more frequent headaches and by the overuse of acute medications.

P-762 - Depression and anxiety in inflammatory bowel disease in remission

The presence of anxiety and depression has important implications for Inflammatory Bowel Diseases (IBD) management. The aims of our study were to examine the levels of anxiety and depression in IBD patients in remission and compared to those without IBD. A total of 180 patients with IBD, 88 with Crohn's disease (CD) and 92 with ulcerative colitis (UC), in remission (defined by clinical criteria), aged 19–65, of both genders (96 males and 84 females), without known or evident psychiatric disorders, without other chronic disease or the history of surgical treatment, were enrolled in the study. The control group consisted of 180 subjects without IBD. The levels of anxiety and depression were obtained by the Hamilton Anxiety Rating Scale (HAMA-14) and Hamilton Depression Rating Scale (HAMD-21). Among IBD patients 56.7% of them had no anxiety, 32.1% had mild anxiety and 11.2% had moderate anxiety. Without depression was 11.1% of patients, mild depression had a 55.6%, 32.2% had moderate depression and 1.1% had severe depression. There was a statistically significant difference in distribution of patients by categories of anxiety (P < 0.01) and by categories of depression (P < 0.01). In the control group, 94% were free of anxiety and 61.1% had no depression. There was no statistically significant difference between CD and UC. There was significant difference between control and IBD group by levels of anxiety and depression.

Growth in children with established renal failure a Registry analysis (Chapter 14)

Short stature is a major problem in paediatric ERF patients with 29% of transplant patients and 41% of dialysis patients below the second percentile for height. Only 6.5% of transplant patients and 15.5% of dialysis patients are receiving rhGH. There is no significant difference in the height distribution of patients commencing RRT and those who have had a functioning allograft for at least 1 year. In patients with at least 2 years between presentation and RRT, there is a significant fall in height Z score. This overall statistic is strongly influenced by the very poor growth of patients with glomerular disease.

Effects of a Medical Intensivist on Patient Care in a Community Teaching Hospital

To determine the effect of adding a trained intensivist on patient care and educational outcomes in a community teaching hospital. We retrospectively reviewed outcomes for patients admitted to the medical intensive-care unit (MICU) of a 270-bed community teaching hospital between July 1992 and June 1994. Mortality rates and durations of stay were determined for the year before (BD, 1992 through 1993) and the first year after (AD, 1993 through 1994) introduction of a full-time director of critical care. Performance of resident trainees on a standardized critical-care examination was measured for the same periods. Overall, 459 patients in the BD period were compared with 471 patients in the AD period. The mix of cases and severity of illness (acute physiology and chronic health evaluation or APACHE II scores) on admission were similar for the BD and AD periods. MICU mortality decreased from 20.9% during the BD to 14.9% during the AD period (P = 0.02), and in-hospital mortality decreased from 34.0% to 24.6% (P = 0.002). Disease-specific mortalities were lower during the AD period for most categories of illness. Detailed analysis of a subgroup of patients (those with pneumonia) demonstrated no differences in distribution of patients by gender, race, or acuity of illness (APACHE II scores). The mortality rate due to pneumonia decreased from 46% during the BD period to 31% during the AD period. This decrease was consistent across categories of APACHE II scores. From BD to AD periods, mean durations of total hospital stay decreased from 22.6 +/- 1.4 days to 17.7 +/- 1.0 days, and mean MICU stay decreased from 5.0 +/- 0.3 days to 3.9 +/- 0.3 days (P < 0.05). Critical-care in-service examination scores for 22 residents increased from 53.8 +/- 1.7% to 67.5 +/- 2.2% (P < 0.01), and AD scores were significantly higher than BD scores for residents at similar levels of training. Addition of a medical intensivist was temporally associated with improved clinical and educational outcomes in our community teaching hospital.