Mean Hospital Days Research Articles

A comparison of medical resource use for 4 chemotherapy regimens as first-line treatment for metastatic colorectal cancer (MCRC): XELOX vs. FOLFOX4 ± bevacizumab (A)

4098 Background: A recent randomized phase III trial with a 2x2 factorial design compared 4 chemotherapy regimens as first-line treatment for MCRC: oral capecitabine + i.v. oxaliplatin q3w (XELOX); 5-FU/LV + i.v. oxaliplatin (FOLFOX4); XELOX+A; and FOLFOX4+A. The XELOX regimens were found to be non-inferior to FOLFOX4 in terms of progression-free survival (the primary endpoint), and the A regimens were superior to the placebo arms. The attractiveness of these regimens to providers, patients, and payers will also depend on the medical resources involved. The purpose of this analysis was to compare the expected resource use across the 4 groups. Methods: A resource use model was constructed based on trial data and projections from trial protocols. Both medical resources and patient time were considered. The medical resources included visits for chemotherapy administration, central venous access (CVA), treatment of adverse events (AEs), and hospital use for common treatment-related AEs. Patient time for chemotherapy administration, ambulatory visits, and hospital stays was estimated. Results: FOLFOX and FOLFOX4+A required more administration visits due to the q2w cycle (22–27 visits in total for the FOLFOX arms vs. 7–9 visits for the XELOX arms). With FOLFOX regimens, patients spend 60–200 additional hours receiving i.v. drug administration, and 22–27 additional hours traveling and waiting to receive chemotherapy. The rate of hospital admissions for common AEs did not differ among the arms, but mean hospital days for common AEs were slightly higher in the XELOX arms. Ambulatory encounters to treat AEs added only about 1 hour of encounter time per patient on average in all 4 arms. The 2 FOLFOX4 arms had twice as many placements for CVA. Conclusion: In the first-line setting, the 2 FOLFOX4 chemotherapy regimens involve substantially more i.v. drug administration visits and time - the equivalent of more than two 40-hour workweeks. The 4 regimens were similar in terms of the amount of resource use needed to treat AEs. No significant financial relationships to disclose.

Invited commentary

The timely and appropriate management of complicated fibropurulent pleural effusions and acute and chronic empyemas remains a challenging issue. Chan and colleagues [1Chan D.T.L. Sihoe A.D.L. Chan S. et al.Surgical treatment for empyema thoracis: is video-assisted thoracic surgery “better” than thoracotomy?.Ann Thorac Surg. 2007; 84: 225-231Abstract Full Text Full Text PDF PubMed Scopus (91) Google Scholar] have reported on a significant experience in managing these patients with both open and minimally invasive techniques, and although their series is not randomized, the patients have been arbitrarily directed to two medical centers where either the open or minimally invasive approaches were used exclusively. The outcomes associated with the two techniques are remarkably similar. Treatment success was routinely accomplished in both groups with no requirements for reinterventions, as well as mortality and complication rates that compare very favorably to historic series. It is likely that differences in medical systems and practice patterns explain the differences from previously published reports in patient time on antibiotics (76 and 54 days), mean hospital days (21 and 16 days), and time to return to work (6.4 and 4.6 months), especially because this population was quite young with a mean age in both treatment groups of less than 50 years of age. The report includes a significant percentage of patients with challenging technical situations in that approximately one third of patients had tuberculosis empyemas, and three quarters were assessed to be in the “organizing phase” of their intrapleural infection. This study does not differentiate, however, between acute and chronic empyemas, especially those with fibrothorax in which true decortication has historically required sharp dissection of restricted lung, not simply blunt stripping of pleural peel. Although treatment success was routinely achieved, the authors present comparative data obtained at only two points: “immediately” after the surgery and then at a mean of 36 months (range, 6 to 65 months) postoperatively. This does not provide an adequate opportunity to assess outcomes over time, and it is particularly puzzling in that all patients were routinely seen four weeks after discharge for follow-up chest x-ray films, but no intermediate data on dyspnea or postoperative pain was obtained at that point. The authors use the Medical Research Council dyspnea index and an approach to pain assessment similar to the standard visual analog system. Except for pain scores immediately after surgery, no significant differences were noted. This is not surprising considering that the minimally invasive group used a true thoracoscopic approach, whereas the open group applied a full posterior lateral thoracotomy, not a muscle-sparing or limited rib-spreading approach. In addition, we have no information regarding the various approaches to postoperative pain management in either group. Assessment of clinical outcomes would have been enhanced not only with more regular symptomatic assessment, but also documentation of quality of life measurements. Instead the authors have provided the more difficult to interpret assessment of “overall satisfaction” and “satisfaction with wounds” as the only long-term differences between treatment groups. This report appropriately outlined the underlying treatment goals in all patients with acute and chronic empyemas, which is to maximize drainage and to free the trapped lung to completely fill the pleural space. This goal was accomplished with remarkable consistency in both treatment groups. The fact that no patients required reinterventions may be unprecedented. The title asks “Is Video-Assisted Thoracic Surgery Better Than Thoracotomy?” The issue currently is not which approach is better, but the realization that, in experienced hands dedicated to adhering to standard technical outcome principals, minimally invasive approaches can provide excellent outcomes in these complicated patients. Surgical Treatment for Empyema Thoracis: Is Video-Assisted Thoracic Surgery “Better” Than Thoracotomy?The Annals of Thoracic SurgeryVol. 84Issue 1PreviewOperations for empyema thoracis are conventionally performed by open thoracotomy, whereas the video-assisted thoracic surgery (VATS) approach remains controversial. This study compares the radiologic and functional outcomes of decortication using the two approaches. Full-Text PDF

A controlled, mirror-image study of second-generation antipsychotics in the treatment of schizophrenia

Second-generation antipsychotics are now treatments of choice in many countries. In this study, we aimed to compare hospital stay and admissions to hospital in patients switching from first-generation (conventional) to second-generation (atypical) antipsychotics with patients switching from one first-generation drug to another. This was a retrospective, 6-year, controlled mirror-image study conducted in an acute general psychiatry services in an inner-city area. Subjects were consisted of patients diagnosed with schizophrenia or schizoaffective disorder receiving continuous prescription of antipsychotics over at least a 6-year period between 1994 and 2002. The main outcome measures were number of days spent in hospital and number of admissions to hospital. In 36 patients switched from first to second-generation antipsychotics, total number of days spent in hospital increased, from a mean of 90 days in the 3 years before switching, to a mean of 200 days in the 3 years after (P<0.001). Mean number of admissions did not change significantly (1.61 before vs. 1.44 after, P=0.360). In 36 matched control patients, switching between first-generation antipsychotic drugs, mean number of days in hospital fell from 64 to 50 (P=0.189) and number of admissions was virtually unchanged (1.42 before vs. 1.03 after, P=0.202). Mean days in hospital were significantly increased in the second-generation antipsychotic group compared with the first-generation antipsychotic (control) group (P<0.001). Switching from first to second-generation antipsychotics resulted in an important increase in number of days spent in hospital. Switching from one first-generation antipsychotic drug to another did not significantly affect number of days in hospital.

Intrathecal Narcotic Infusion Pumps (ITNP) for Intractable Chronic Pancreatitis Pain: A Pilot Series

Pain management remains the largest clinical problem for many chronic pancreatitis (CP) patients. Escalating narcotic requirements often make the clinician seek alternatives such as pancreas rest via jejunal feedings, surgical pancreatic denervation or pancreatectomy. Intrathecal narcotics are an alternative which offers the advantages of 1) reversibility; 2) lower total narcotic dose; 3) pancreas remains intact. Aim We herein report our experience with 9 such patients followed up to 6 years. Methods: 9 CP patients (etiology idiopathic 6, cystic fibrosis 2, lupus/HIV 1) with intractable upper abdominal pain, daily narcotic use, frequent hospitalizations, and failed pain relief with jejunal feedings and ERCP sphincter therapy were offered ITNP after a successful temporary intrathecal block. An intrathecal catheter was placed at L2-L3 interspace and subcutaneous pump placed in lower abdomen. Infusion rates were titrated to patient need with morphine equivalent doses of 2-10 mg per day. Results: Mean duration of ITNP in situ was 38 months (range 3-72 months). Mean oral narcotic dose before ITNP: 360 morphine equivalent mg per day; after: 45 mg per day. Mean hospital days before ITNP: >30 per year; after <2 per year. Four of 9 patients resumed at least partial work schedules. All patients stated that ITNP was at least moderately helpful for pain control. Major complications were: Catheter displacement (1); repositioned via surgery. Pedal lymphedema (1). No patient developed diabetes or worse steatorrhea. Summary In this pilot series, ITNP use in CP patients with high narcotic requirement and intractable pain resulted in improved pain control, much less daily narcotic use, and much fewer hospital days in all patients. The minority of patients resumed work. Complications were infrequent. Conclusions: ITNPs are an acceptable alternative for CP patients with high narcotic requirements and intractable pain.

Service utilization and associated direct costs for bipolar disorder in 2004: An analysis in managed care

Background Bipolar disorder is a chronic and costly condition. This analysis examines health care costs associated with bipolar disorder in 2004 and contrasts them with those for depression, a better understood mental illness. Methods Health care costs associated with bipolar disorder and non-bipolar depression were determined using private payer administrative claims. Individuals having 2 claims with a primary ICD-9-CM code for bipolar disorder or depression were categorized as bipolar disorder or non-bipolar depression patients, respectively. Comparisons between patient groups were adjusted for demographic differences and comorbid diagnoses. Results On average, bipolar patients ( n = 6072) used significantly more psychiatric resources per person than depression patients ( n = 60,643), and had more mean psychiatric hospital days, psychiatric and medical emergency room visits, and psychiatric office visits ( p < .001 for all). Bipolar patients were slightly less likely to be treated with antidepressants, but substantially more likely to be treated with antipsychotics, anticonvulsants, lithium, and benzodiazepines ( p < .001 for all). Mean direct per-patient costs were $10,402 for bipolar patients and $7494 for depression patients ( p < .001), with the primary differences observed for psychiatric medication ($1641 vs. $507) and psychiatric hospitalization ($1187 vs. $241). Limitations Patients were categorized based on diagnostic codes in administrative claims data, which may not always be accurate. Results may not generalize beyond private payer populations in the US. Conclusions Bipolar disorder is associated with significantly greater per-patient total annual health care costs than non-bipolar depression, as well as significantly greater psychiatric costs. Bipolar disorder, a chronic condition often suboptimally treated, may represent a good target for disease-management programs.

Psychological treatment may reduce the need for healthcare in patients with Crohnʼs disease

Few published studies examine the influence of psychological treatment on health care utilization in Crohn's disease. The present substudy of a prospective, randomized, multicenter trial conducted in 69 of 488 consecutive Crohn's disease (CD) patients was designed to investigate the way in which healthcare utilization is influenced by psychotherapy and relaxation in addition to standardized glucocorticoid therapy. Before and after a 1-year period of standardized somatic treatment the psychotherapy and control groups were compared with regard to hospital and sick-leave days. Predictors of healthcare utilization were analyzed. The comparison between groups before and after psychological treatment showed a significantly higher decrease of mean hospital days (P < 0.03) and sick-leave days in the treatment group compared with the controls. When a covariate analysis was applied to compare the data at randomization, the difference in hospital days remained statistically a trend (P < 0.1). Multivariate regression analysis detected a significant gender and depression effect for hospital days (cor r(2) = 0.114) and a significant gender and age effect for sick-leave days (cor r(2) = 0.112). A significant drop in healthcare utilization after psychological treatment demonstrates a clear benefit of this additional therapy. This is important, since the study failed to demonstrate significant changes in the psychosocial status or somatic course of study patients. Clinical and psychological factors influencing these outcomes are discussed.

Risk Factors for Anastomotic Leakage after a Low Anterior Resection for Rectal Cancer

Purpose: Clinical anastomotic leakage remains a major problem after a low anterior resection for rectal cancer, so indentifing risk factors influencing anastomotic leakage is important. The aim of this study was to assess the association between risk factors and anastomotic leakage. Methods: One thousand two hundred eight patients underwent a primary resection for rectal cancer from June 1993 to March 2007. We used hospital records and the colorectal cancer registry to analyze retrospectively the case histories of those patients. The operations were performed using a low anterior resection with the double stapling method. All patients underwent a tumor-specific mesorectal excision. Of the total, thirty-eight patients showed anastomotic leakage. Univariate and multivariate analyses were performed to assess the risk factors affecting to the anastomotic leakage. Results: The rate of anastomotic leakage was 3.2% (38 of 1,208 patients) with a mortality rate of 7.9% (3 of 38 patients). The overall mortality rate was 0.3% (3 of 1,208 patients). Males accounted for 28 of the 38 patients with leakage, and female accounted for the the account for the remnant 10. The mean age was 53.7 years (33∼74 years). The mean leakage day was 11.8th day (3∼37th day) after the operation, and the mean hospital day was 39.2 days (7∼131 days). The mean body mass index (BMI) was 22.7 kg/m2 (15.7∼30.8 kg/m2). The mean operation time was 230.5 minutes (90∼425 minutes), and the mean bleeding loss was 519.5 cc (0∼3,500 cc). Conclusions: Significant risk factors for anastomotic leakage after primary resection for rectal cancer were the transfusion amount during surgery, a preliminary colostomy, and nodal stage.

Preoperative portal vein embolization with a mixture of gelatin sponge and iodized oil: efficacy and safety

To evaluate whether portal vein embolization (PVE) using a mixture of gelatin sponge (GS) pieces and iodized oil is safe and effective in inducing hypertrophy of the future liver remnants (FLR). PVE was performed in 14 patients (eight male and six female, mean age 65 years, range 35-81 years) diagnosed with malignant liver tumor before surgery, whose FLR volumes were judged too small to allow for safe resection. Liver volume change, biochemical data change, complications related to PVE, and postoperative complications were retrospectively evaluated. PVE was successful in all patients, and there were no procedural complications. Absolute FLR volume and FLR/total liver volume (TLV) ratio increased by 102 cm3 and 8% (mean values), respectively. Planned hepatectomies were cancelled in three patients due to extrahepatic metastasis or bile duct infection. Five of the 11 patients (45%) who underwent hepatectomies had major postoperative complications. However, complications due to hepatic failure were not seen. In 10 patients, except one whose outcome was fatal outcome, the mean hospitalization days with and without major complications were 73 and 33 days, respectively. PVE using a mixture of GS and iodized oil seems to be effective and safe in inducing hypertrophy of the FLR.

Long-term effects of video-assisted thoracoscopic thymectomy for myasthenia gravis: 5-year follow-up of 18 cases

To evaluate the long-term effects of video-assisted thoracoscopic thymectomy for myasthenia gravis (MG). Eighteen MG patients, 7 males and 11 females, aged 33.4 +/- 9.4 (19 - 48), underwent video-assisted thoracoscopic thymectomy by the same surgical group from November 2001 to May 2005. Right side access was used in 14 of them, left side approach was used in 2, and bilateral approach in 1 of them. The thymus and fatty tissue in the front mediastinum were resected. The medical records were reviewed and telephone survey was conducted to understand the effects. The mean follow-up time was 26.4 +/- 10.9 months. VATS was successfully conducted except in 1 case. The bleeding volume was less than 50 ml. The average chest tube drainage time was 2.1 +/- 1.2 days, and the mean hospitalization day was 6.3 +/- 3.1 days. Three of the 18 patients needed temporary mechanical ventilation less than 72 hours, and 2 needed reintubation due to either myasthenic or cholinergic crises. Nine of the 18 patients achieved complete relief (50%) and 6 of them (33.3%) had their symptoms greatly improved, and the symptoms of one case remained stable (5.6%), and the overall effective rate was 83.3%. Video-assisted thoracoscopic thymectomy is a safe and effective method for treatment of myasthenia gravis with satisfactory long-term outcomes.

Adverse Clinical Consequences of Hyperglycemia from Total Parenteral Nutrition Exposure during Hematopoietic Stem Cell Transplantation

Immunocompromised hematopoietic stem cell transplant (HSCT) recipients frequently receive total parenteral nutrition (TPN), a dextrose-based solution that may exacerbate the infectious risks associated with hyperglycemia. This study assessed the incidence of hyperglycemia (glucose level ≥110 mg/dL) and its effect on clinical outcomes in TPN versus non-TPN recipients who received HSCTs. A retrospective cohort of 357 adults who were admitted for initial autologous or allogeneic transplantation at 2 university-affiliated centers was examined. To discern the temporality of outcomes, “before” and “after” comparisons were made by using actual infusion times for TPN patients and using timeframes based on mean hospital days before (“before”) or during (“after”) parenteral infusion for non-TPN patients. Patients demonstrated similar demographic and clinical characteristics when analyzed by institution, feeding, and donor-type strata, and 57% received TPN. After attempts to equilibrate disease acuity were employed, the proportion of hyperglycemic days was equivalent before but significantly greater after in patients exposed versus unexposed to TPN (87.5% versus 8.3%, respectively; P < .001). Using logistic regression, the likelihood of infection doubled (odds ratio [OR], 2.2; 95% confidence interval [CI], 1.4-3.5) after adjustment for donor type, diagnosis, age, gender, ethnicity, institution, mucositis, and obesity. This association was only slightly attenuated when patients with infections before were removed (OR, 1.9; 95%, CI, 1.1-3.3), steroid recipients were eliminated (OR, 2.1; 95% CI, 1.2-3.4), and when patients with nonablative regimens were excluded (OR, 2.1; 95% CI, 1.3-3.5), but was considerably higher for patients who were classified as normal or underweight (body mass index ≤25 kg/m 2; n = 118; OR, 4.3; 95% CI, 1.7-10.6). In addition, the effect of TPN became insignificant when glucose was added as an independent variable, thus symbolizing their collinear relation. Parenteral nutrition recipients versus nonrecipients also developed significantly greater requirements for red cell ( P = .001) and platelet transfusions ( P = .001) after and significant delays in granulocyte and platelet engraftment times for autologous ( P = .01) and allogeneic ( P = .02) subjects. The broad use of TPN in patients undergoing initial HSCT was associated with profound hyperglycemia, resultant greater morbidity, and questionable efficacy in this adult, well-nourished cohort.

Experience of laparoscopic salvage surgery for locally recurrent rectal cancer

To investigate the feasibility of the laparoscopic salvage surgery for locally recurrent rectal cancer. Seven cases with recurrent rectal carcinoma treated by laparoscopic salvage surgery from February 2004 to July 2005 were retrospectively analyzed. Among them, four were males and 3 females, and the median age was 60 years (range 37-74). Three cases of recurrence were after conventional anterior resection, 2 after laparoscopic-assist anterior resection, 1 after laparoscopic-assist Parks' procedure, and 1 with pars sacral fistula after per-sacral-local resection for three times. Image examination (CT scanning) was taken preoperatively to evaluate the locally recurrence and exclude the distant metastases. The laparoscopic-assist procedure with or without a hand-assist technique was used in this study. Six cases with the recurrent lesion of central type were treated by salvage surgical procedure as follows: 3 laparoscopic-assist anterior resection, 1 laparoscopic-assist abdominoperineal resection, 1 laparoscopic-assist posterior exenteration, and 1 laparoscopic-assist proctocolectomy with a terminal ileum stoma. All of them were R0 resection confirmed by postoperative pathological examination. The other one with the lesion of combination type was treated with the procedure of laparoscopic-assist sigmoid colostomy. A hand-assist technique was used in 2 cases. The mean operation time, bleeding and hospital day was (211 +/- 13) min, (200 +/- 91) ml, and (15 +/- 10) d, respectively. No conversion and complication occurred. Laparoscopic salvage surgery for locally recurrent rectal cancer is safe and feasible when taken by experienced laparoscopic colorectal surgeon to the cases with the recurrent lesion of central type.

Comparison of piperacillin/tazobactam and imipenem/cilastatin, both in combination with tobramycin, administered every 6 h for treatment of nosocomial pneumonia

This randomized, double-blind, multicenter study compared the efficacy and safety of piperacillin/tazobactam (P/T) and imipenem/cilastatin (IMP), both in combination with an aminoglycoside, in hospitalized patients with acute nosocomial pneumonia (NP). Patients with acute NP, defined as pneumonia with symptoms > or = 48 h after admission or < or =7 days after hospital discharge, received infusions of 4 g/500 mg P/T or 500 mg/500 mg IMP every 6 h. Endpoints were clinical cure and microbiological response rates; pathogen eradication rates; length of hospital stay; hospital readmissions; and adverse events (AEs). Of 437 patients in the intent-to-treat population, 197 were efficacy evaluable. At test-of-cure, response rates were similar between groups. Within the efficacy evaluable population, 68% of P/T patients and 61% of IMP patients were clinically cured (P = 0.256). Microbiological responses for P/T and IMP patients were: eradication, 64% versus 59%; persistence, 29% versus 21%; relapse, 0% versus 5%; and superinfection, 7% versus 15%, respectively. Gram-positive isolates were eradicated in 83% of P/T patients and 75% of IMP patients; Gram-negative pathogens were eradicated in 72% of P/T patients and 77% of IMP patients. Treatment groups had similar number of mean hospital days, readmission rates, and frequency of AEs. This study showed that P/T administered four times per day was as safe and efficacious as IMP in treating hospitalized patients with NP.

Randomized clinical trial of a postdischarge pharmaceutical care program vs. regular follow-up in patients with heart failure

To assess the efficacy of a multifactorial educational intervention carried out by a pharmacist in patients with heart failure (HF). A randomized, prospective, open clinical trial in patients admitted for HF. The patients assigned to the intervention group received information about the disease, drug therapy, diet education, and active telephone follow-up. Visits were completed at 2, 6, and 12 months. Hospital re-admissions, days of hospital stay, treatment compliance, satisfaction with the care received, and quality of life (EuroQol) were evaluated; a financial study was conducted in order to assess the possible impact of the program. The intervention was performed by the pharmacy department in coordination with the cardiology unit. 134 patients were included, with a mean age of 75 years and a low educational level. The patients of the intervention group had a higher level of treatment compliance than the patients in the control group. At 12 months of follow-up, 32.9% fewer patients in the intervention group were admitted again vs. the control group. The mean days of hospital stay per patient in the control group were 9.6 (SD=18.5) vs. 5.9 (SD=14.1) in the intervention group. No differences were recorded in quality of life, but the intervention group had a higher score in the satisfaction scale at two months [9.0 (SD=1.3) versus 8.2 (SD=1.8) p=0.026]. Upon adjusting a Cox survival model with the ejection fraction, the patients in the intervention group had a lower risk of re-admission (Hazard ratio 0.56; 95% CI: 0.32-0.97). The financial analysis evidenced savings in hospital costs of euro 578 per patient that were favorable to the intervention group. Postdischarge pharmaceutical care allows for reducing the number of new admissions in patients with heart failure, the total days of hospital stay, and improves treatment compliance without increasing the costs of care.

Value of CT and clinical criteria in assessment of patients with acute pancreatitis

Objective To re-assess the value of CT and clinical criteria as prognostic and severity indicators in acute pancreatitis and the correlation between them. Methods Sixty-five cases with acute pancreatitis (AP) were included in the study. The hospitalization days, fevering days and overall complications were regarded as clinical endpoints for the patient group. CT criteria used for AP evaluation included Balthazar's plain CT scan score, CT severity index (CTSI) and London's pancreatic size index (PSI) score. Clinical criteria was Ranson score. The correlations between each criterion and the clinical endpoints, and the relation between CT and clinical criteria were analyzed. The power of each criterion and combination of CT and clinical criteria in predicting overall complications of AP were assessed and compared by using a receiver operative characteristic curve (ROC) analysis. Results The mean scores of PSI, Ranson among the three groups classified according to overall complications were significantly different. Except Balthazar's plain CT scan criterion, each criterion's mean score in-groups with local complications was significantly higher than that in-group without. The overall complications were significantly more in severe group than that in mild group classified according to each criterion except plain CT scan criterion. Mean days of hospital stay and fevering were significantly longer in severe group with Ranson score than that in mild group. PSI and Ranson score had a linear correlation with fevering days, and Ranson score had a linear correlation with hospitalization days. In CT criteria, only PSI had a linear correlation with Ranson score. The findings of plain CT scan was found to be some laggard compared with that of clinic. ROC analysis showed the largest A Z of Ranson score, and there was no A Z increase when CT criteria were added to clinical criteria. Conclusion The predictive values of Ranson and PSI score in AP patients are superior to that of other criteria. CT criteria are superior to clinical criterion in predicting local complications, and short-term CT follow-up examination is important in the evaluation of AP.

Thoracic Epidural Versus Intercostal Nerve Catheter Plus Patient-Controlled Analgesia: A Randomized Study

Pain control is an important issue after thoracotomy. Ideal methods should have a high success rate, with easy implementation and minimal complications. Debate exists over the optimal pain control method. This randomized trial was designed to compare epidural (EPI) and intercostal nerve catheter with patient-controlled analgesia (ICN-PCA) for pain control after thoracotomy. The study included 124 randomized patients; 91 had sufficient data for analysis (44 EPI, 47 ICN-PCA). The primary endpoint was pain measurement using a composite of a visual analogue scale, numerical rating, and categorical rating. A second endpoint was the success rate of each method. Pulmonary function tests, antibiotics, intensive care unit (ICU), and hospital days, and use of nonprotocol pain medications were also compared. There were 12 pain observations per patient (90% completed on days 1 to 5). The pain composite revealed an average postoperative pain score of 2.4 on a scale from 0 (no pain) to 10 (worst pain). There was no difference between the groups. Failures of the planned method of analgesia included 9 in the EPI group and 4 in the ICN group (p = 0.23). Another 20 patients were excluded (no difference between groups) due to unsuspected mediastinal metastases precluding thoracotomy (n = 13), and other miscellaneous factors precluding follow-up (n = 7). The EPI group had an increased number of urinary catheter days (2.5 days vs 1.7, p = 0.002) and increased narcotic supplements (p = 0.03) compared with ICN. Mean ICU days (0.9) and hospital days (6.2) were similar for both groups, and there were no differences in arrhythmias, pneumonias, transfusions, and antibiotic use. Significant differences were seen (p = 0.001) between preoperative and postoperative pulmonary function tests in both groups. However, there were no differences in pulmonary function when the groups were compared with each other. Satisfactory pain control was achieved after thoracotomy using either EPI or ICN-PCA. The ICN-PCA achieved equivalent pain control compared with EPI, and was placed by the surgeon with no delays in surgery, and demonstrated a decreased requirement for Foley catheter duration.

Infliximab maintenance treatment reduces hospitalizations, surgeries, and procedures in fistulizing Crohn’s disease

Infliximab is effective in closing fistulas in patients with Crohn's disease. We examined the effect of infliximab maintenance treatment on hospitalizations, surgeries, and procedures in patients with fistulizing Crohn's disease enrolled in the ACCENT II study. After 5 mg/kg infliximab at weeks 0, 2, and 6, a total of 282 patients were separately randomized at week 14 as responders (at least a 50% reduction from baseline in the number of draining fistulas at both weeks 10 and 14) or nonresponders to receive placebo or 5 mg/kg infliximab maintenance every 8 weeks. At week 22 and later, patients who lost response could be treated with a maintenance dose 5 mg/kg higher. Data on Crohn's disease-related hospitalizations, surgeries, and procedures were compared between the treatment groups for responders and all randomized patients. A total of 282 patients were randomized at week 14, of whom 195 were randomized as responders. Among patients randomized as responders, those who received infliximab maintenance had significantly fewer mean hospitalization days (0.5 vs. 2.5 days; P < .05), mean numbers (per 100 patients) of hospitalizations (11 vs. 31; P < .05), all surgeries and procedures (65 vs. 126; P < .05), inpatient surgeries and procedures (7 vs. 41; P < .01), and major surgeries (2 vs. 11; P < .05), compared with those who received placebo maintenance. In patients with fistulizing Crohn's disease, infliximab 5 mg/kg every 8 weeks significantly reduced hospitalizations, surgeries, and procedures compared with placebo.

Palifermin Reduces Estimated Downstream Costs of Autologous Stem Cell Transplant (SCT): Analysis of Phase 3 Trial Results.

Introduction: Oral mucositis is a frequent and debilitating complication in patients (pts) who undergo high-dose chemotherapy (HDC) with SCT support and is associated with significantly worse clinical and economic outcomes in such settings (Sonis et al, J Clin Oncol, 2001). In a phase 3 randomized, placebo-controlled, double-blind clinical trial of palifermin in pts with hematologic malignancies undergoing HDC and total body irradiation (TBI) with auto-SCT support, palifermin (a rHuKGF molecule) has been shown to reduce the incidence, severity, and duration of oral mucositis as well as its downstream outcomes (bacteremia, febrile neutropenia [FN], total parenteral nutrition [TPN], and intubation) and hospitalization in this population (Spielberger, et al, ASCO, 2003). We estimated the expected impact of palifermin on the hospital costs of transplantation.Methods: We classified the 212 pts from the phase 3 trial by presence of downstream outcomes of oral mucositis (bacteremia, FN, TPN, intubation) and by the number of hospital days. The cost of hospital days was not collected in the clinical trial, hence, we estimated cost from the hospital claims of a nationally representative sample of pts with hematologic malignancies who underwent auto-SCT after TBI. We obtained charges from the National Inpatient Sample (NIS, 2000–2001), transformed them into costs using state-specific Medicare cost-to-charge ratios for operating and capital costs for urban centers, and adjusted them to 2003 U.S. dollars using the Consumer Price Index for medical care. We computed the mean cost per hospital day for NIS pts with 0, one, or more of the 4 downstream outcomes (FN, bacteremia, TPN, intubation), and applied these costs to the number of hospital days of clinical trial pts with corresponding downstream outcomes. We compared the estimated total hospital costs of palifermin pts to placebo pts. Out-pt costs of SCT were not estimated and the cost of palifermin has not yet been determined, therefore neither was included in this analysis.Results: The age and sex distributions of NIS and clinical trial pts were virtually identical as were the mean hospital days (22.52 vs. 22.87 days), but non-Hispanic whites were more common in the clinical trial population (79% vs. 63%). In pts with hematologic malignancies, the national mean cost per hospital day for auto SCT after TBI was $2,702, ranging from $2,572 per day when no downstream outcomes occurred to > $5,000 per day when all 4 downstream outcomes occurred. Applying these differing costs to the differing outcomes of clinical trial pts, the mean cost per pt was $61,160 with palifermin and $76,104 with placebo, yielding a mean savings of $14,943 per pt (95% CI: $12,043–$17,845) in this population. Savings will be partially offset by the cost of palifermin and may vary among centers, particularly those that perform outpatient transplants. Extrapolations of these data to the allogeneic and autologous non-TBI settings also will be presented.Conclusion: The clinical efficacy of palifermin should lead to significant hospital cost savings for pts with hematologic malignancies undergoing auto-SCT following HDC and TBI. The magnitude of savings will depend on the cost of the drug.

NON-OPERATIVE TREATMENT FOR PERFORATED DUODENAL ULCER

The aim of this study is to review our recent experience with selective non-operative management of perforated duodenal ulcers (PDU). The patients included in this study had PDU treated non-operatively between 1995–2002. The protocol for the management of PDU has been developed based on experience at our department. Our policy of the selective treatment for PDU was that patients over 65 years old had immediate laparoscopic omental patch repair (LOPR) and the other was selected non-operative management. Non-operative management consisted of intravenous fluids, broad-spectrum antibiotics, nasogastric tube suction (occasionally) ultrasound guided percutaneous drainage of intraperitoneal fluids (occasionally) and H2 blockers. All patients had emergency endoscopies before treatments and were made diagnoses of PDU. If evidence of peritonitis progressed, or if there was not evidence of regression by 24–48 hours, laparoscopic surgery was indicated. Endosopic examination was performed on about 4–5th day, and if the perforation sealing was confirmed, oral diet resumption was then started. Helicobacter pylori (HP) status was checked after discharge. One hundred twenty-six PDU patients were evaluated. The patients ranged in age from 17 to 99 years old, with a mean age of 49 years. Males predominated in a ratio of 4:1. Ninety-nine (79%) of the 126 cases with PDU had non-operative treatment. There were 85 men and 14 women. Non-operative treatment was abandoned in 9 cases (9%) due to deteriorating peritonitis and converted to laparoscopic interventions. Mean hospital stay for the 27 patients treated operatively was 30+-22 days; the mean hospital day of the 99 patients primarily treated non-operatively was 20+-11 days. Re-perforation did not occur. The overall mortality rate was 7%. The mortality rate for the patients treated operatively was 26%; the mortality of the patients primarily treated non-operatively was 2%. The1death in this latter group occurred in a man with cardiopulmonary arrest on arrival and the other death occurred in a man with chronic pulmonary failure. Overall positive rate of IgG and HP status was 73 and 56%, respectively. Non-operative management for the relatively younger patients with PDU can be safely performed. We emphasize in our study the labour intensive process that is required to achieve acceptable results.

Failed Biliary ERCP: A Prospective Multicenter Study of Risk Factors, Complications, and Resource Utilization

BACKGROUND: The predictors and outcomes associated with failed ERCP (fERCP) have not been elucidated. Hypotheses: 1) ERCP success varies by prior ERCP history, indication, and endoscopist case volume, 2) complications are as common in fERCP as in successful ERCP (sERCP) and 3) resource utilization in fERCP exceeds that of sERCP with complications. METHODS: A prospective multicenter (6 private, 5 university) study of consecutive biliary ERCPs with 30-day follow up. 1040/2071 ERCPs met inclusion criteria after excluding stent changes, follow-up procedures to remove residual stones or redilate strictures, and those for pancreatic endotherapy. Failure was defined as unsuccessful CBD cannulation, or the inability to establish sufficient drainage as reported by the endoscopist. RESULTS: Failures occurred in 203/1040 (19.5%) ERCPs, including failure of sedation in 40 (19.7%), cannulation in 100 (43.9%), stone removal in 17 (8.4%), and stricture drainage in 23 (11.3%). Failure occurred in 45/161 (28%) of malignant stricture cases and 87/617 (14.1%) of those for CBD stones. Of 72 cases employing precut sphincterotomy, 28 (38.9%) failed. By multivariate analysis, factors associated with failure (odds ratio, 95% CI) included endoscopist case volume of <3/mo (2.84, 1.62-5.00), surgically altered GI anatomy (2.48, 1.13-5.45), previous fERCP (4.37, 2.00-9.57), and indication of malignant strictures (2.89, 1.9-4.3) or SOD (2.24, 1.29-3.90). Previous ERCP decreased failure odds (0.42, 0.22-0.79). Fellow involvement and other indications had no effect. Excluding sedation failures, complications as defined by consensus criteria occurred in 35/163 (21.5%) of fERCP vs 61/837 (7.3%) of sERCP (p<0.001). ERCP-related deaths followed 3 fERCP vs 2 sERCP (p=0.03). Subsequent endoscopic, surgical, or radiologic procedures were required in 100 (61.4%) fERCP vs 7 (11.5%) of sERCPs with complications (p<0.002) and 18 (2.2%) of sERCP without complications. Mean hospital days included 7.8 (4.2 ERCP-related) for fERCP and 4.6 (1.7 ERCP-related) for sERCP (the latter including 8.1 days (6.1 ERCP-related) for sERCP with complications). CONCLUSIONS: Failed ERCPs incur three times as many complications as sERCP, frequent reinterventions, and major ERCP-related resource utilization. Low-endoscopist case volume, history of fERCP, surgically altered GI anatomy, malignant strictures, and SOD are associated with higher odds of failure.

Most Common Intoxication in Nephrology Ward Organophosphate Poisoning

Objectives. In Taiwan, the widespread use of organophosphates (OPs) in agricultural and household environments results in numerous OP poisoning. To better understand the clinical significance of associated parameters on respiratory failure and patient outcome, we evaluate patients admitted to the Nephrology ward in our hospital with OP intoxication. Patients and Methods. Over a period of 2 years, a total of 42 consecutive patients with OP poisoning admitted to the nephrology ward or the Intensive Care Unit of Chang‐Gung Memorial Hospital were the subjects in the study. The diagnosis of poisoning was based on history of ingestion and characteristic clinical features of anticholinesterase agent poisoning. Prior to treatment, all symptoms recorded at emergency room and blood samples for blood chemistry including plasma amylase and plasma acetyl‐cholinesterase were collected from each patient immediately after the admission. Results. As clinical manifestations of OP show, nausea and vomiting and salivation were the leading manifestations, 45.2% and 33.3%, respectively. Patients who developed respiratory failure were older than those who did not (54.3 ± 6.9 vs. 43.1 ± 5.6, p < 0.05). The dosage of atropine administered for treatment was significantly higher in the patient group with respiratory failure compared to those without respiratory failure (29.7 ± 14.5 vs. 9.1 ± 10.2, p < 0.05). Plasma amylase level of the patient group with respiratory failure was significantly higher than those without respiratory failure (436.1 ± 87.1 vs. 181.3 ± 29.6, p < 0.01). Of course, mean days of hospitalization in the respiratory failure group are significantly longer than the other group (12.1 ± 2.1 vs. 5.4 ± 1.9, p < 0.05). Based on univariant analysis, bradycardia, hypotension, fasciculation and coma were significant factors associated with respiratory failure. The dose of atropine administered for treatment was significantly higher in the oral exposure group compared to nonoral exposure group (23.6 ± 12.6 vs. 10.6 ± 6.4, p < 0.05). The same is true for the pralidoxime treatment (9.6 ± 1.9 vs. 5.3 ± 1.4, p < 0.05). As for mean days of hospitalization (11.6 ± 3.9 vs. 6.4 ± 2.1, p < 0.05) and fatality (2 vs. 0, p < 0.05), those of oral exposure patients were significantly longer and higher than those with nonoral exposure. Conclusions. We demonstrate that elevated plasma amylase concentration was related to the development of respiratory failure in OP intoxication. It also provided us various important risk factors to identify those patients with OP poisoning who would ultimately require ventilatory support.