Patient retention of training in self-administration of intravenous antibiotic therapy in an outpatient parenteral antibiotic therapy service.

AIMS AND OBJECTIVES: To assess patient retention of initial training on completion of self-administration of a prolonged course of intravenous therapy. BACKGROUND: Outpatient parenteral antibiotic therapy is being used increasingly in the UK, and patients requiring prolonged antibiotic courses may be trained to self-administer therapy. DESIGN: Prospective clinical evaluation. METHODS: Patients self-administering parenteral antibiotic therapy through the Sheffield outpatient parenteral antibiotic therapy service were assessed when nearing completion of therapy for correct technique in five key areas of proficiency using a scoring system. RESULTS: Twenty-nine patients and nine carers were reassessed, at a median interval of 35 days after completion of the initial training package. Of these, 35 of 38 were fully competent in all areas. Three patients showed incomplete retention of their initial training. All made errors relating to use of sterile technique. CONCLUSIONS: Overall retention of training was excellent, and this supports earlier reports that patient-administered outpatient parenteral antibiotic therapy is as safe as nurse-administered therapy. However, this study highlighted a small number of patients or carers who were not fully competent at maintaining sterile technique, and as a result, the protocol for training patients has been altered. RELEVANCE TO CLINICAL PRACTICE: In this study, we assess patients' ability to maintain safe self-administration of therapy over a period of time. Patients are increasingly involved and engaged in their own health care, and this study provides a novel approach to assessing their competence in practical procedures.

Arteriotomy closure device safety after percutaneous coronary intervention in the direct thrombin inhibitor era: a comparative study.

OBJECTIVES: To investigate the safety and risk of vascular complications of arteriotomy closure devices (ACD) with the direct thrombin inhibitor bivalirudin in patients undergoing percutaneous coronary intervention (PCI). BACKGROUND: ACDs and manual compression have been shown to have a similar risk of complications in the setting of PCI with heparin ± glycoprotein (GP) IIb/IIIa inhibitor usage. In many centers bivalirudin is becoming the most frequent type of anticoagulation used during PCI. We sought to determine the risk of vascular complications using Angio-Seal, Perclose, and manual compression for groin hemostasis using predominantly bivalirudin. METHODS: Our institution's interventional database retrospectively identified 14,354 consecutive patients undergoing PCI from 2000 to 2008. Patients were grouped by the adjunctive anticoagulation used (bivalirudin vs. heparin + GP IIb/IIIa inhibitors) as well as ACD employed. The incidence of complications was evaluated using multivariable analysis to account for baseline differences between groups. RESULTS: Patients undergoing PCI with adjunctive bivalirudin had significantly fewer complications overall, regardless of closure method (2.9% vs. 8.7%, P < 0.001). The Perclose group had significantly fewer complications than the Angio-Seal and manual compression groups (3.9% vs. 5.6% vs. 9.0%, P < 0.001) respectively; the Angio-Seal group had significantly fewer complications than manual compression. Multivariable analysis also identified age ≥ 65, female gender, BMI ≤ 26, and operator as independent predictors of complications. CONCLUSIONS: The use of adjunctive bivalirudin during PCI was associated with fewer vascular complications. In addition, the Perclose and Angio-Seal devices had significantly fewer complications than manual compression and women ≥ 65 are at highest risk.

Late outcomes after carotid artery stenting versus carotid endarterectomy: insights from a propensity-matched analysis of the Reduction of Atherothrombosis for Continued Health (REACH) Registry.

BACKGROUND: In patients with carotid artery disease, carotid endarterectomy (CEA) and carotid stenting (CAS) are treatment options. Controversy exists as to the relative efficacy of the 2 techniques in preventing late events. METHODS AND RESULTS: The Reduction of Atherothrombosis for Continued Health (REACH) Registry recruited > 68,000 outpatients ≥ 45 years of age with established atherothrombotic disease or ≥ 3 risk factors for atherothrombosis. Patients with CAS or CEA were chosen and followed up prospectively for the occurrence of cardiovascular events. Propensity score matching was performed to assemble a cohort of patients in whom all baseline covariates would be well balanced. Primary outcome was defined as death or stroke at the 2-year follow-up. Secondary outcome was stroke or transient ischemic attack. Tertiary outcome was a composite of death, myocardial infarction, or stroke and the individual outcomes. Of the 68 236 patients with atherothrombosis, 3412 patients (5%) had a history of carotid artery revascularization (70% asymptomatic carotid stenosis), 1025 (30%) with CAS and 2387 (70%) with CEA. Propensity score analyses matched 836 CAS patients with 836 CEA patients. At the end of 2 years of follow-up, in the propensity score-matched cohort, CAS was associated with a risk similar to CEA for the primary (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.57 to 1.26), secondary (HR, 1.20; 95% CI, 0.73 to 1.96), and tertiary (HR, 0.72; 95% CI, 0.51 to 1.01) composite outcome, death (HR, 0.63; 95% CI, 0.40 to 1.00), and stroke (HR, 1.48; 95% CI, 0.79 to 2.80). CONCLUSIONS: In a real-world cohort of patients with a history of carotid artery revascularization, CAS was comparable to CEA for late outcomes.

High dose-rate endobronchial radiotherapy for proximal airway obstruction due to lung cancer: 8-year experience of a referral center.

The efficacy of high dose-rate endobronchial radiotherapy (HDERT) against proximal airway obstruction that results from lung cancer has not been thoroughly evaluated. This study retrospectively reviewed tumor/obstruction characteristics prior to therapy, interventions applied, symptoms before and after intervention, complications, and survival of all patients with proximal airway obstruction resulting from lung cancer who received HDERT between 1995 and 2003 in a tertiary teaching center. Thirty-four (34) patients received HDERT, while 28 had additional treatment (external radiotherapy = 23, neodymium yttrium aluminum garnet laser ablation = 9, stenting = 7, electrosurgery = 5, cryosurgery = 3, and photodynamic therapy = 1). Sixteen (16) patients developed complications, the most frequent being respiratory failure and bronchial-wall necrosis, while 19 experienced symptomatic relief. The median (95% confidence interval) survival of these 34 patients was 7.8 (5.9-9.8) months, significantly longer (p = 0.004) than a historic control of 3.9 (3.7-7.1) months from the Cleveland Clinic Foundation, in Cleveland, OH, and comparable to other previous reports. No single factor predicted complications or symptomatic relief. However, female gender, presence of only one symptom, absence of fatigue/weight loss, >1 HDERT sessions, and postprocedure symptom relief were associated with improved survival. Contemporary HDERT with or without additional treatment modalities is effective against central airway compromise resulting from lung cancer.

Association between time from endometriosis surgery and outcome of in vitro fertilization cycles.

OBJECTIVE: To evaluate the effect of time from surgery on the outcome of subsequent in vitro fertilization (IVF) cycles in endometriosis patients. STUDY DESIGN: One hundred five women treated surgically for endometriosis and who underwent 252 IVF cycles were included. Approximately 1/2, 1/4 and 1/5 of the study group underwent 1, 2 and 3 cycles, respectively. We used the cycle as the basic unit of analysis with the time since surgery as the independent variable and the clinical pregnancy as the dependant variable. We used nonparametric approach for estimating the probabilities. To convey the uncertainty of the probability estimates, we produced bootstrap 95% CI. RESULTS: The overall pregnancy rate was 31%. There does not appear to be any relationship between the length of time from surgery and clinical outcome. The point estimates suggest that there may be a slight negative relationship, since the estimated probability decreases steadily from 0.34 to 0.21 as the time since surgery goes from 0.5 to 5 years. CONCLUSION: The data do not provide evidence for a strong relationship between the time since surgery and the probability of a clinical pregnancy with IVF.

Effect of estrogens on skin aging and the potential role of SERMs.

In humans, structural and functional changes attributable to aging are more visibly evident in the skin than in any other organ. Estrogens have significant effects on skin physiology and modulate epidermal keratinocytes, dermal fibroblasts and melanocytes, in addition to skin appendages including the hair follicle and the sebaceous gland. Importantly, skin aging can be significantly delayed by the administration of estrogen. This paper reviews the effects of estrogens on skin and the mechanisms by which estrogens can alleviate the changes due to aging that occur in human skin. The relevance of estrogen replacement therapy (HRT) in postmenopausal women and the potential value of selective estrogen receptor modulators (SERMs) as a therapy for diminishing skin aging are also highlighted.

Effect of dexamethasone on atrial fibrillation after cardiac surgery: prospective, randomized, double-blind, placebo-controlled trial.

OBJECTIVE: The purpose of this study was to assess the effect of preoperative dexamethasone (DEX) on the occurrence of postoperative atrial fibrillation (AF). DESIGN: Prospective, randomized, double-blind, placebo-controlled clinical trial. SETTING: Tertiary referral center. PARTICIPANTS: Seventy-eight adult patients undergoing combined valve and coronary artery bypass graft (CABG) surgery were randomized to receive either DEX or placebo. INTERVENTIONS: The DEX group received dexamethasone, 0.6 mg/kg, after induction of anesthesia, and the placebo group received an equal volume of normal saline. Interleukin (IL)-6, -8, and -10; tumor necrosis factor alpha; and endothelin (ET)-1 were measured preoperatively and on postoperative days (POD) 1, 2, and 3. Complement (C-4) and C-reactive protein (CRP) were measured preoperatively and on POD 2. Exhaled nitric oxide (NO) was measured preoperatively, 15 minutes after aortic unclamping, and 1 hour after intensive care unit admission. MEASUREMENTS AND MAIN RESULTS: No significant difference in the incidence of AF was found between the placebo (41%) and DEX groups (30%) (95% confidence interval [-11%, 34%); p = 0.31). DEX significantly reduced at least 1 postoperative level of IL-6, IL-8, IL-10, CRP, and exhaled NO. DEX did not affect ET-1 or C-4 levels. IL-10 on POD 3 was positively correlated with postoperative hospital length of stay (r = 0.30, p = 0.01). Increased levels of IL-8 and IL-10 on POD 1 were positively correlated with the intubation time (r = 0.31, p = 0.01; r = 0.30, p = 0.01, respectively). Conversely, C-4 on POD 2 was negatively correlated with the intubation time and intensive care unit length of stay (r = -0.32, p = 0.006; r = -0.30, p = 0.01, respectively). CONCLUSIONS: DEX did not affect the incidence of AF in patients undergoing combined CABG and valve surgery. However, it did modulate the release of several inflammatory and acute-phase response mediators that are associated with adverse outcomes.

A multivariate analysis of risk factors associated with subcapsular hematoma formation following electromagnetic shock wave lithotripsy.

PURPOSE: Subcapsular or perinephric hematoma is one of the most frequent and potentially serious complications of extracorporeal shock wave lithotripsy (SWL). We determined the incidence of and risk factors for renal hematomas following electromagnetic shock wave lithotripsy. MATERIALS AND METHODS: Between February 1999 and August 2003, 570 SWL treatments were performed using a Modulith SLX electromagnetic lithotriptor (Storz, St. Louis, Missouri). A total of 415 of these treatments in 317 patients were performed for stones in the renal pelvis or calices and these treatment episodes represent the study group reported. Treatment episodes were reviewed from a prospective institutional review board approved registry and analyzed for patient age, gender, body mass index, mean arterial pressure at induction, stone location, total number of shock waves and peak shock wave intensity. RESULTS: Following these 415 episodes subcapsular or perinephric hematomas developed in 17 patients for an overall incidence of 4.1%. The probability of hematoma after shock wave lithotripsy increased significantly as patient age at treatment increased, such that the probability of hematoma was estimated to be 1.67 times greater for each 10-year incremental increase in patient age. None of the other variables analyzed were significantly related to the incidence of hematoma formation at the 0.05 level. CONCLUSIONS: The incidence of renal hematoma formation following electromagnetic SWL for renal calculus was 4.1%. The probability of hematoma increased significantly with increasing patient age but it was not associated with increasing mean arterial pressure at treatment. These findings are in contrast to previous reports of hematoma associated with electrohydraulic SWL. These differences may be a consequence of the smaller focal zone and higher peak pressure associated with Storz Modulith electromagnetic SWL and, just as importantly, a consequence of the difference in the manner in which blood pressure was defined.

Fertility is reduced after restorative proctocolectomy with ileal pouch anal anastomosis: a study of 300 patients.

BACKGROUND: Restorative proctocolectomy and ileal pouch anal anastomosis (RP/IPAA) has become the gold standard surgical therapy for the majority of patients with mucosal ulcerative colitis and familial adenomatous polyposis. The aims of this study were to evaluate the fertility rates before and after RP/IPAA, to compare them with the reproductive data of the general United States population, and to determine surgical parameters that might influence subsequent fertility. METHODS: Three hundred women of reproductive age who underwent RP/IPAA between 1983 and 2001 completed a mailed questionnaire regarding their reproductive function before and after the procedure. Additional information was obtained from the pelvic pouch database. The reproductive information was compared to age-matched historical control subjects from the United States general population. The associations between changes in fertility and surgical parameters were also investigated. RESULTS: The median (25th, 75th percentile) age at surgery was 28 (24, 33) years. Out of 300 women, 206 attempted to conceive. Before operation, 48 (38%) of 127 patients were unsuccessful after 1 year of unprotected intercourse, whereas after operation, 76 (56%) of 135 patients were unsuccessful. This infertility rate was higher after operation than before (P <.001). For the subgroup of 56 women who tried to get pregnant both before and after operation, the infertility rate was higher after operation than before (69% vs 46%; P=.005). Also, a higher percentage of these patients who had an intraoperative transfusion were infertile after operation compared to patients who did not have an intraoperative transfusion (54% vs 21%; P=.023). CONCLUSIONS: There was an increase in the infertility rate after RP/IPAA. Intraoperative blood transfusion had a negative impact on the fertility rate after operation in patients who tried to conceive both before and after RP/IPAA.

Differential growth of human embryos in vitro: role of reactive oxygen species.

OBJECTIVE: To examine the relationship of early human embryonic development with the level of reactive oxygen species (ROS) in the culture media on the first day (day 1 ROS) after insemination. DESIGN: A prospective study. SETTING: Patients undergoing assisted reproduction in a teaching hospital. PATIENT(S): Patients undergoing conventional IVF (n = 104; 115 cycles) and intracytoplasmic sperm injection (ICSI) (n = 91; 96 cycles) were included. Both fertilization and early cultures were performed in human tubal fluid with 5% serum substitute supplement. INTERVENTION(S): Day 1 ROS levels in the central well (sample) and the outer well (control) of each embryo culture dish were measured after overnight incubation by chemiluminescence assay using luminol as the probe. MAIN OUTCOME MEASURE(S): Fertilization rate and embryo quality at day 3 and 5 were recorded for each cycle. Age, parity, and demographic features were also compared. RESULT(S): High day 1 ROS levels in culture media were associated with low blastocyst rate, low fertilization rate, low cleavage rate, and high embryonic fragmentation with ICSI but not with conventional IVF. High day 1 ROS levels in culture media were associated with lower pregnancy rates in both IVF and ICSI cycles. CONCLUSION(S): Reactive oxygen species generated in culture media by day 1 may be an important biochemical marker for early embryonic growth. Increased embryonic fragmentation and slow cleavage rate may be partially attributed to early exposure of embryos to high ROS levels in ICSI cycles. Differential growth of ICSI embryos incubated under identical conditions may be in part due to differences in ROS levels of the culture medium surrounding these embryos.

Factors related to delayed graft function after laparoscopic live donor nephrectomy.

PURPOSE: Delayed graft function after live donor transplantation affects 5% to 10% of recipients regardless of procurement technique. This delay in function is associated with an increased risk of rejection and decreased graft survival. In the present study we critically assess allograft recovery to identify the risk factors related to delayed graft function. MATERIALS AND METHODS: We retrospectively reviewed donor and recipient medical records from 100 consecutive laparoscopic live donor nephrectomies from August 1997 to October 2001. Four criteria were used to classify delayed graft function: I) requirement of dialysis in postoperative week 1, II) creatinine 2.5 mg/dl or greater at postoperative day 5, III) time to half peak activity (mercaptoacetyltriglycine renal scan) at postoperative day 5 greater than 12.2 minutes (normal range 1 to 12.2) and IV) time to peak activity (mercaptoacetyltriglycine renal scan) at day 5 greater than 6.5 minutes (normal range 2.1 to 6.5). Patients could qualify for multiple outcome categories. Patients who did not match any of these criteria were classified as having normal renal function (outcome 0). RESULTS: The number of patients in the delayed graft function categories were 5 with outcome I, 14 with outcome II, 39 with outcome III and 24 with outcome IV. There were 23 patients represented in more than 1 category and 59 patients were classified as having normal function. Recipient age, donor/recipient gender relationship, unrelated highly mismatched donors and cold/total preservation time were identified as risk factors related to impaired early renal function recovery. None of the variables related to the laparoscopic technique itself represented risk factors for delayed graft function. CONCLUSIONS: Female donor kidneys into male recipients and highly HLA mismatched donors represent factors that may be controlled by donor selection when feasible. All attempts should be made to decrease cold ischemia time and, therefore, total preservation time. Prolonged carbon dioxide pneumoperitoneum, warm ischemia time, renal artery length or use of right kidney did not adversely affect the functional outcome of the allografts procured laparoscopically.

Relationship between ROS production, apoptosis and DNA denaturation in spermatozoa from patients examined for infertility.

BACKGROUND: The aim of this study was to examine the role of apoptosis and reactive oxygen species (ROS) in inducing DNA damage in ejaculated spermatozoa. METHODS: We examined ejaculated spermatozoa from 31 patients examined for infertility and 19 healthy donors for apoptosis, production of ROS and DNA damage using annexin V binding, chemiluminescence assay and sperm chromatin structure assay. RESULTS: The percentage of spermatozoa that underwent apoptosis in the whole ejaculate and mature fraction was higher in the patients than in the donors (P<0.001 and P=0.009, respectively). Levels of ROS in the whole ejaculate and immature fraction were higher in the patients than in the donors (P=0.002 and P=0.009). Apoptosis was significantly correlated with ROS within patients in the whole ejaculate [r (95% confidence interval)=0.53 (0.19-0.86)] and in the mature [0.71 (0.39-1.00)] and immature spermatozoa [0.75 (0.45-1.00)]. Only apoptosis and the DNA fragmentation index (DFI) were significantly correlated within patients in the whole ejaculate [0.57 (0.18-0.97)]. CONCLUSIONS: DNA damage may be induced by oxidative assault. Apoptosis may not contribute significantly to the DNA damage.

Prospective assessment of Cleveland Global Quality of Life (CGQL) as a novel marker of quality of life and disease activity in Crohn's disease.

OBJECTIVES: The Short Form 36 (SF-36) questionnaire is the most widely accepted measure of quality of life (QOL); however, it is cumbersome to use and requires complicated analysis. The Cleveland Global Quality of Life (CGQL) is a simpler tool, which has been validated in patients with ulcerative colitis undergoing restorative proctocolectomy. This study validates CGQL in patients with Crohn's disease and determines the correlation of QOL measurement systems with disease activity as measured by the Crohn's Disease Activity Index (CDAI). METHODS: All patients with Crohn's disease presenting to this department between September 2001 and February 2002 were prospectively entered into a database, including demographic data, disease manifestations, Vienna classification, age at diagnosis, and duration of Crohn's disease. SF-36, CGQL, and CDAI scores were entered concurrently. Cronbach's alpha was used to assess the internal consistency among the components of the CGQL score. Correlation among various QOL measures was assessed with Spearman's test. Relationships between QOL measures and various baseline factors were assessed by Wilcoxon rank sum test, Student's t test, Kruskal-Wallis test, and Pearson's test, depending on the type and distribution of data. Change from baseline in the CGQL was assessed with the Wilcoxon signed rank test. RESULTS: One hundred seventy-eight (178) patients were entered into the database, and 169 completed QOL and CDAI data. There was a significant correlation between SF-36 and CGQL. CGQL and SF-36 correlated similarly with CDAI. Neither patient age, gender, or smoking history were associated with CGQL. CONCLUSIONS: CGQL correlates with disease activity and is a simple measure of QOL in Crohn's disease.

Comparative analysis of laparoscopic versus open partial nephrectomy for renal tumors in 200 patients.

PURPOSE: Laparoscopic partial nephrectomy is an emerging minimally invasive, nephron sparing approach for renal cell carcinoma. We compared perioperative outcomes after laparoscopic and open nephron sparing surgery (NSS) for patients with a solitary renal tumor of 7 cm or less at a single institution. MATERIALS AND METHODS: Since September 1999, 100 consecutive patients have undergone laparoscopic partial nephrectomy for a sporadic single renal tumor of 7 cm or less at our institution. A contemporary cohort of 100 consecutive patients with similar inclusion criteria have undergone open NSS since April 1998. Since our laparoscopic technique was based on our established open surgical principles, the 2 approaches were similar, including transient renal vascular control, sharp tumor excision in a bloodless field, pelvicaliceal repair when necessary, suture ligation of transected intrarenal blood vessels and suture repair of the renal parenchymal defect over a bolster. Demographic, intraoperative, postoperative and short-term followup data were retrospectively compared between the 2 groups. RESULTS: Median tumor size was 2.8 cm in the laparoscopic group and 3.3 cm in the open group (p = 0.005). There were significantly more tumors greater than 4 cm in the open group (p <0.001). There were more patients with a solitary kidney in the open surgical group (p = 0.002). More patients in the open group underwent NSS for a malignant tumor (p = 002). Comparing the laparoscopic versus open groups, median surgical time was 3 vs 3.9 hours (p <0.001), blood loss was 125 vs 250 ml (p <0.001) and mean warm ischemia time was 27.8 vs 17.5 minutes (p <0.001), respectively. In the laparoscopic and open groups median analgesic requirement was 20.2 vs 252.5 mg morphine sulfate equivalents (p <0.001), hospital stay was 2 vs 5 days (p <0.001) and average convalescence was 4 vs 6 weeks (p <0.001). Median preoperative serum creatinine (1.0 vs 1.0 mg/dl, p = 0.52) and postoperative serum creatinine (1.1 vs 1.2 mg/dl, p = 0.65) were similar in the 2 groups. No kidney was lost due to warm ischemic injury. Three patients in the laparoscopic group had a positive surgical margin compared to none in the open groups (3% vs 0%, p = 0.1). Laparoscopic NSS was associated with a higher rate of major intraoperative complications (5% vs 0%, p = 0.02). There were no significant differences in overall postoperative complications, although renal/urological complications were more common in the laparoscopic group (11% vs 2%, p = 0.01). CONCLUSIONS: Open surgical partial nephrectomy remains the established standard for nephron sparing treatment of renal tumors. When applied to small renal tumors, the laparoscopic approach is associated with longer warm renal ischemia time, more major intraoperative complications and more postoperative urological complications. Our data also suggest that more deliberate efforts to achieve a wider surgical margin are necessary with the laparoscopic approach. Nevertheless, our data suggest that laparoscopic NSS is emerging as an effective, minimally invasive therapeutic approach with respect to renal functional outcome with the additional advantages of decreased postoperative narcotic use, earlier hospital discharge and a more rapid convalescence. Continued efforts are required to develop laparoscopic renal hypothermia techniques and facilitate intrarenal suturing, while minimizing warm ischemia time.