Ambulatory Therapy Research Articles

Gynecologic chemotherapy at the ambulatory therapy center in Kobe City Medical Center General Hospital

Gynecologic chemotherapy at the ambulatory therapy center in Kobe City Medical Center General Hospital

Prognostic Impact of Cytogenetic Abnormalities in Elderly Patients with Acute Myeloid Leukemia (AML) Enrolled in the ALFA-9803 Trial.

We have recently reported the superiority of prolonged ambulatory versus short intensive post-remission therapy in 416 patients with AML aged 65 years or more (median age, 72 years) selected to be treated intensively in the ALFA-9803 trial (C. Gardin et al. Blood 2007). We report here on the prognostic value of cytogenetic abnormalities in 339 of these patients with available karyotype (27 not done, 50 failures). When classical endpoints (CR rate, DFS, OS) were used, we were only able to identify one very unfavorable subgroup of 14% patients (N=49 with −7, abnormalities of both chromosomes 5 and 7, 3q abnormality, or complex karyotype with 5 abnormalities or more; CR rate, 30%). No significant differences in outcome were found between patients with any other abnormality and the 171 patients with a normal karyotype/−Y (overall CR rate, 62%). When cumulative incidences of AML-related events (primary refractory AML, relapses) were used as endpoints with induction deaths and deaths in first CR as competing events, three distinct subsets were more easily identified:1.14% very unfavorable-risk patients, as detailed above;2.59% standard-risk patients (N=200 with t(8;21), inv(16), normal karyotype/−Y, or isolated +8; CR rate, 65%); and3.27% unfavorable-risk patients (N=90 with other abnormalities, including notably 5q− and 7q−; CR rate, 58%).Median failure-free interval (Fig 1; P<.001, by the Gray test) and relapse-free interval (Fig 2; P<.001, by the Gray test) were 2.3, 12.4, and 8.1 months and 4.2, 15.0, and 10.5 months in these three subsets, respectively. Interestingly, prolonged ambulatory post-remission therapy was associated with longer DFS and OS in the standard-risk subset only. The results demonstrate that despite their poor general outcome, older patients with AML may be subdivided in three meaningful cytogenetic subgroups. This 3-subgroup classification should help to optimize disease management decisions such as intensive versus non-intensive or investigational therapies for induction or consolidation. [Display omitted] [Display omitted]

Regional models of care for systemic therapy: Standards for organization and delivery

17057 Background: Rapidly expanding indications for cancer systemic therapy combined with human resource and facility constraints require innovative approaches to deliver safe, patient-centred, and evidence-based care across Ontario, a province covering 1 million sq km, organized into 14 regions, each with about 1 million inhabitants. A systemic therapy project team recommended the best way to organize the delivery of ambulatory systemic therapy in Ontario. Methods: A core multidisciplinary panel reviewed the evidence and developed standards. The panel used evidence-based analysis of relevant publications, an environmental scan of other existing recommendations and expert opinion based on experience and consensus to formulate a standards document to guide treatment delivery. This was reviewed and amended by the full project team. The document was circulated to oncologists, family practitioners, internists, pharmacists, nurses and administrators who work in or have responsibility for systemic therapy in the regions for practitioner feedback. Results: A Regional Systemic Therapy Program (STP) Model was developed in which Integrated Cancer programs (ICPs) provide comprehensive cancer services, leadership of quality and overall organisation/coordination for the region. STPs include ICPs directly linked to satellite centres and also affiliated to centres with their own systemic therapy programs to provide appropriate systemic therapy services for all regions under a common set of standards. Five levels of care are recommended, with complexity and availability of services differentiating the levels. For each level, standards were established for; 1-Providers and their roles, 2-Education for providers, 3-Service type and complexity, 4-Service volumes, 5- Quality assurance and safety, 6-Facility requirements, 7-Administrative and organizational responsibilities. The intent is to provide the same standard of care in the most appropriate setting within the appropriate time frame. STPs will implement, monitor and evaluate quality indicators. Conclusions: A detailed review of the document including results of practitioner feedback as well as survey results from the 14 STPs to determine whether standards are being currently met will be presented. No significant financial relationships to disclose.

Successful treatment with voriconazole of Aspergillus brain abscess in a boy with medulloblastoma

Invasive aspergillosis is an increasing problem in immuno-incompetent patients after prolonged steroid therapy, cancer radio-chemotherapy, and bone marrow or solid organ transplantation. Cerebral aspergillosis is a well-described complication of the invasive aspergillosis but only in rare cases, the brain is the sole site of infection. Despite increasing availability of antifungal drugs, the prognosis of cerebral aspergillosis is poor. We report on an 11-year-old boy with medulloblastoma in the area of the fourth ventricle. Following tumor surgery and radio-chemotherapy, several abscess-like structures occurred in the operating field. After incomplete abscess, resection histology and culture confirmed a localized Aspergillus fumigatus infection. The initial treatment of the Aspergillus fumigatus infection with conventional amphotericin B failed, and treatment with the triazole voriconazole was started. Intravenous treatment with voriconazole resulted in a reduction of the Aspergillus fumigatus abscess. After switching to oral ambulatory therapy, the Aspergillus fumigatus abscess increased in size. To improve treatment, voriconazole dosage was adapted to reach drug concentrations in cerebrospinal fluid (CSF) above the minimal fungicidal concentration and plasma specimens. During the concentration-controlled voriconazole therapy for a period of 18 months, a complete response was achieved.

Portosystemic Encephalopathy in a Patient Treated With Peritoneal Dialysis

We present a case of a 75-year-old man with end-stage renal disease caused by immunoglobulin A nephropathy who developed hepatic encephalopathy 15 months after starting continuous ambulatory peritoneal dialysis therapy. Liver test results were normal except for hyperammonemia (ammonia, 317 microg/dL [186 micromol/L]) and mildly increased alkaline phosphatase and gamma-glutamyl transpeptidase levels. Abdominal ultrasonography showed normal liver architecture, and color Doppler ultrasonography showed a normal splenic-portal axis with hepatopetal blood flow. Histological examination of a laparoscopic liver biopsy specimen showed moderate fibrosis limited to portal tracts without necrosis or inflammation. Magnetic resonance angiography and percutaneous transhepatic portal angiography showed a large shunt between the left gastric and azygous veins, with blood flowing from the portal vein to the superior vena cava. The patient was transferred to hemodialysis treatment, and although his condition improved slightly, episodes of encephalopathy did not disappear. Surgical ligation of the left gastric vein was performed. In the 8 months after surgery, he has experienced no further episodes of hepatic encephalopathy or hyperammonemia. We speculate that increased intra-abdominal pressure and vasodilation caused by peritoneal dialysis solutions in a patient with a spontaneous portosystemic shunt resulted in ammonia-rich blood flow from the portal vein to the superior vena cava and encephalopathy. In addition, it is possible that chronic hepatic hypoxia caused by hypoperfusion from portosystemic shunting contributed to the development of liver fibrosis. To our knowledge, this is the first report of spontaneous portosystemic shunt encephalopathy in a patient with a noncirrhotic liver undergoing peritoneal dialysis.

Ambulatory Electroconvulsive Therapy

Ambulatory Electroconvulsive Therapy

Ambulatory Electroconvulsive Therapy. Review of Russian Translation of a 1996 Report of an Association for Convulsive Therapy Task Force

Ambulatory Electroconvulsive Therapy. Review of Russian Translation of a 1996 Report of an Association for Convulsive Therapy Task Force

Home Inotropic Therapy in Children

Inotropic therapy is a well-established practice for children with advanced congestive heart failure (CHF). Traditionally, children have been maintained on inotropic therapy in the hospital under close, monitored supervision. Changes to UNOS listing criteria now allow patients awaiting heart transplantation to be discharged to home yet maintain 1B status. In adults, home inotropic therapy has been shown to be a safe and cost-effective bridge to transplantation. To date, there are limited data on the use of home inotropic therapy in children. We reviewed the safety and efficacy of continuous ambulatory home inotropic therapy in children. Data were obtained from a single institution from January 2000 to January 2007. There were 14 pediatric patients with end-stage CHF, who received home intravenous inotropic therapy. The indications for home inotropic therapy included palliative care (n = 8) and awaiting heart transplantation (n = 6). Patients ranged in age from 6 to 18 years (median 14.5 years). The majority of subjects (n = 11) received milrinone at a dose of 0.5 to 1.0 mug/kg/min, 2 received dobutamine at 5 mug/kg/min, and 1 received both agents. Duration of therapy ranged from 14 to 476 days (median 68 days). There were 26 hospital re-admissions and 4 suspected catheter infections. No unexpected deaths or pump failures occurred. Based on this initial review, continuous home inotropic therapy in children with CHF is safe with few complications. Home inotropic therapy may result in substantial cost-savings and improve family dynamics by avoiding prolonged hospitalization.

Factors Affecting Exercise Capacity in Renal Transplantation Candidates on Continuous Ambulatory Peritoneal Dialysis Therapy

Factors Affecting Exercise Capacity in Renal Transplantation Candidates on Continuous Ambulatory Peritoneal Dialysis Therapy

Outpatient high‐dose melphalan in multiple myeloma patients

The brief period of neutropenia and limited nonmarrow toxicity after high-dose melphalan (HDM) provide a rationale for outpatient treatment. Our experience with HDM (140-200 mg/m(2)) in 90 consecutive transplant episodes was retrospectively reviewed. Most patients were treated in an outpatient setting. Patients without a primary care provider (PCP) were electively admitted before the anticipated onset of neutropenia. Ceftriaxone was added to ciprofloxacin at the onset of neutropenia. All febrile patients were admitted. The median time from peripheral blood progenitor cell infusion to onset of neutropenia was 5 days (range, 4-6 days), and the mean duration of neutropenia was 5 days (range, 4-7 days). Thirty-eight transplants (42%) were performed entirely in the outpatient setting. The mean duration of hospitalization was 2.2 days in patients not electively admitted. The use of ceftriaxone was associated with a decreased risk for fever (39% vs. 79%) and reduced duration of hospitalization (1.6 days vs. 4.5 days) for nonelectively admitted patients. There was no treatment-related mortality. Ambulatory therapy with HDM is safe and can be achieved in a general outpatient setting. The predictable time to neutropenia allows even poor candidates for outpatient therapy to be admitted electively on Day +4. The apparent beneficial effect of ceftriaxone needs to be confirmed in randomized trials.

Chronomodulated Irinotecan, Oxaliplatin, and Leucovorin-Modulated 5-Fluorouracil as Ambulatory Salvage Therapy in Patients with Irinotecan- and Oxaliplatin-Resistant Metastatic Colorectal Cancer

To evaluate the activity and tolerability of salvage chronomodulated chemotherapy combining irinotecan (I), 5-fluorouracil/leucovorin (5-FU/LV), and oxaliplatin (O) (chronoIFLO) in patients with metastatic colorectal cancer (MCRC) and prior progression on four drugs. Seventy-seven nonhospitalized MCRC patients received chronoIFLO every 3 weeks, with day 1: I (180 mg/m2 over 6 hours, with peak infusion rate at 05:00) and days 2-5: 5-FU/LV (700/300 mg/m2 per day over 12 hours, with peak flow rate at 04:00), and O (20 mg/m2 per day over 12 hours, with peak flow rate at 16:00). Toxicity and response were assessed every 3 weeks and every 2 months, respectively. RESULTS. Three or more prior chemotherapy lines were given to 75% of the patients. Two or more organs had metastatic disease in 65% of the patients. A median number of six courses of chronoIFLO was given. The main grade 3-4 toxicities were diarrhea (39% of the patients, 9% of the courses) and neutropenia (30% of the patients and 7% of the courses). Grade 3 peripheral sensory neuropathy occurred in 14% of the patients. Two patients achieved a partial response and 61 had stable disease, resulting in disease control for 82% of the patients. The median time to progression (TTP) was 5.5 months (95% confidence interval, 3.7-6.0). The median overall survival time was 14.2 months (9.8-17.3). Baseline performance status, serum carcinoembryonic antigen (CEA) level, and CEA doubling time were independent prognostic factors of TTP. ChronoIFLO safely and durably halted tumor progression in most extensively pretreated MCRC patients.

Cost-effectiveness of Rosiglitazone Oral Combination for the Treatment of Type 2 Diabetes in Germany

To assess the cost-effectiveness of rosiglitazone in combination with other oral agents for the treatment of overweight and obese patients with type 2 diabetes in Germany. The Diabetes Decision Analysis of Cost--type 2 model was adapted for clinical practice and healthcare financing rules in Germany. The model was calibrated using Cost of Diabetes in Europe Type 2 study data and national statistics. The perspective is that of the sickness funds, and includes all hospital inpatient, ambulatory, rehabilitation, and diabetes therapy, other medications, and sickness leave. The model simulates lifetime treatment histories and associated health outcomes and costs for age and sex-matched cohorts of 1000 overweight and obese patients. The measures of effectiveness used in the analysis were life-years and quality adjusted life-years (QALYs). The combination therapy of rosiglitazone with metformin or sulfonylurea produces better glycaemic control than conventional care of metformin with sulfonylurea and insulin in most patients, extends the viability of oral therapy before requiring insulin, and typically leads to lifetime cost increases across all treatment types. The improvements in glycaemic control lead to survival gains and reductions in morbidity, because of the reduced risk of developing or progressing to later stages of complications. Improvements in morbidity and mortality generate additional QALYs. Costs and health outcomes combine to yield favourable incremental cost-effectiveness ratios, which fall below international 'willingness-to-pay' thresholds in the medium term. The model predicts that rosiglitazone in combination with other oral agents is a cost-effective intervention for the treatment of normal weight, overweight and obese patients with type 2 diabetes when compared with conventional care in Germany.

Effect of parathyroid hormone on cellular immunity in uremic patients undergoing peritoneal dialysis

Objective The clinical relevance of altered lymphocyte function and its possible relation with uremic toxins such as parathyroid hormone (PTH) is not well understood. We studied the changes in cellular immunity in patients on continuous ambulatory peritoneal dialysis therapy and examined the relationship between T-lymphocyte function and plasma levels of PTH. Patients and Methods Thirty-seven patients (16 male, 21 female) were enrolled in the study. The patients were divided into 2 groups: 22 patients with increased levels of PTH and 15 patients with normal levels of PTH. Lymphocyte subsets (CD2+, CD3+, CD3+/4+, CD3+/8+, CD19+, CD3−/16+56+, CD4/CD8 ratio) were quantitated in both groups using monoclonal antibodies and flow cytometric analysis. Analysis of variance testing was performed to analyze differences between the groups. Results A significant increase in CD3 was observed in patients with increased levels of PTH (71.6±7.9 vs. 57.5±28.1, p<.05). CD3/8 population was also increased in patients with elevated PTH (26.96±8.01 vs. 20.8±13.78, p=NS). CD4/CD8 ratios were lower in patients with elevated PTH than in those who had normal PTH (1.67±0.78 vs. 3.03±2.54, p<.05). No specific differences were observed between these 2 patient groups in CD19 and natural killer cells. Conclusions Elevated PTH seems to affect lymphocyte function and is associated with changes in cellular immunity in a peritoneal dialysis population. Our study is continuing in order to enlarge the study population and collect more data, which will lead to more solid conclusions.

Conservative versus surgical treatment of venous leg ulcers: A prospective, randomized, multicenter trial

The prevalence of venous leg ulcers is as high as 1% to 1.5%, and the total costs of this disease are 1% of the total annual health care budget in Western European countries. Treatment modalities are conservative or surgical. Subfascial endoscopic perforating vein surgery (SEPS) combined with superficial vein ligation is performed in many centers to address vein incompetence in patients with chronic venous leg ulcers. Several reports describe good healing and low recurrence rates, although a randomized trial to compare surgical treatment including SEPS and treatment of the superficial venous system to conservative modalities has never been performed. Therefore, a prospective, randomized, multicenter trial was conducted to study whether ambulatory compression therapy with venous surgery is a better treatment than just ambulatory compression therapy in venous leg ulcer patients. Patients with an active (open) venous leg ulcer (CEAP C6) qualified for the study. The study consisted of two treatment groups. All patients were treated by standardized ambulatory compression therapy, and half of the patients received SEPS. Concomitant superficial venous incompetence was also treated in the second group. For allocation to both treatment groups, each patient was assigned by a computer program at the randomization center. The primary goal of the study was to compare the ulcer-free period during follow-up in both study groups. Secondary end points were ulcer healing and recurrence rates. From April 1997 until January 2001, 200 ulcerated legs (170 patients) were included in the study in 12 centers in The Netherlands. A total of 97 ulcers were allocated to the surgical group and 103 to the conservative group. Patient characteristics were similar in the two treatment groups at baseline, with the exception of a higher proportion in the conservative group of diabetes mellitus. Healing rates were 83% in the surgical group and 73% in the conservative group (not significant; median time to healing, 27 months). Recurrence rates were the same in both treatment groups (22% surgical vs 23% conservative). During follow-up of a mean of 29 months (median, 27 months) in the surgical group and 26 months (median, 24 months) in the conservative group, we found that in the surgical group, the ulcer-free rate was 72%, whereas in the conservative group this rate was 53% (P = .11; Mann-Whitney test). Patients with recurrent ulceration or medially located ulcers in the surgical group had a longer ulcer-free period than those treated in the conservative group (P = .02 for both). A first-time ulcer and one of the centers also had a positive effect on the ulcer-free period during follow-up (P < .001 and P = .02), independent of the treatment group. Deep vein incompetence did not affect the ulcer-free period. In conclusion, we suggest that patients with medial and/or recurrent ulceration should receive surgery combined with ambulatory compression therapy. A dedicated center should provide care for those patients.

The influence of rest primary brain tumours on disease free and overall survival

11529 Background: We analysed the influence of rest primary brain tumours on disease free survival (DFS) and overall survival (OS). Methods: From 1998 till 2004, 80 patients (pts) with primary brain tumours were treated with postoperative radiotherapy (RT). The male–female ratio was 44 versus (vs) 36 pts (55% vs 45%). The median age was 50 years (yrs) (min 17, max 79 yrs). Performance status was 90–100% in 30 pts, 80–90% in 39 pts and 70–80% in 11 pts. Low grade astrocytoma was reported in 13 pts, anaplastic astrocytoma and glioblastoma in 49 pts, low grade oligodendroglioma in 2 pts, meningeoma in 9 pts and others in 7 pts. The postoperative RT dose was 50 Gy in 20 pts while 60 pts was treated with dose above 50 Gy, 2 Gy per day, 5 fractions per week, linear accelerator X rays, 6 MeV energy. We analysed two groups of pts (50 pts had rest tumours after surgery and RT within 6 months (mo) of operation and 30 pts without rest tumours). We analysed the influence of age, pts ambulatory, corticosteroids therapy during RT, pathohystological diagnoses (PH), RT doses and chemotherapy (CT) application (carmustine, 80 mg/m2, i.v. 1–3 days after 6 weeks of RT completion) on DFS and OS. Results: The median follow up time was 16 mo (min 6, max 96 mo). Thirty pts (37.5%) is still alive while 50 pts (62.5%) died. Cox regression model gave us data of influence on DFS in this way: cortocosteroids therapy during RT, CT application, RT dose and furthermore on OS: age, pts ambulatory, PH report and RT dose. Logistic regression model gave us data for rest tumours group of pts (50 pts) to be the greatest influence on survival patients ambulatory and corticosteroids therapy during RT. Between two groups of pts there is statistically significant difference on DFS and OS (p &lt; 0.001). 1 yrs DFS was 30% and 2 yrs DFS was found in 26% of pts while 1 yrs OS was 44% and 2 yrs OS was 42% of pts. Conclusions: Pts with rest tumours especially anaplastic astrocytoma and glioblastoma have a shorter life span. However, RT dose does influence DFS and OS in pts with good performance status. No significant financial relationships to disclose.

Factors Affecting Exercise Capacity in Renal Transplantation Candidates on Continuous Ambulatory Peritoneal Dialysis Therapy

It is well known that reduced peak oxygen uptake (peak VO2) is a predictor for mortality in several chronic diseases and during the preoperative period. The aim of this study was to investigate the factors that influence peak VO2 in renal transplant candidates receiving continuous ambulatory peritoneal dialysis (CAPD) therapy. We included 22 chronic renal failure patients (12 men, 10 women; ages 29.64 ± 8.29 years; CAPD duration, 37.35 ± 7.15 months) in this study. Pulmonary function tests and symptom-limited cardiopulmonary exercise tests were administered to all patients. Cardiopulmonary exercise tests were performed on a cycle ergometry at the same time of day for all patients. We analyzed the exercise duration, maximum work rate, and peak VO2 level during cycle ergometry. Serum hemoglobin, hematocrit, total cholesterol, triglyceride, blood urea nitrogen, creatinine, albumin, prealbumin, C-reactive protein, sedimentation rate, ferritin, sodium, potassium, parathyroid hormone, calcium, and phosphorus levels were analyzed from samples. Mean values of exercise duration (6.86 ± 1.56 minutes), peak VO2 (17.20 ± 4.91 mL/min/kg), and maximum work rate (77.09 ± 26.09 watts) were lower when we compared them with predicted values for a healthy population. Peak VO2 was well correlated with serum phosphorus levels (4.51 ± 1.28 mg/dL, r = .592, P = .004). Test duration was correlated with peak VO2 ( r = .489, P = .025) and serum phosphorus levels ( r = .530, P = .024). There were no significant correlations with other factors. As a component of ATP, phosphorus is at the hub of the energy-related mechanisms operative in muscles of the respiratory and musculoskeletal systems. Therefore, we suggest that low exercise capacity might be related to low serum phosphorus levels, and that optimal control of serum phosphorus therapy would increase exercise capacity, exercise duration, and oxygen consumption resulting in a decrease of postoperative mortality in renal transplantation candidates.

Ambulatory photodynamic therapy: a new concept in delivering photodynamic therapy

Photodynamic therapy (PDT) has been shown to be effective in treating Bowen's disease, superficial basal cell carcinoma and actinic keratosis. To investigate the feasibility of delivering PDT using a portable light-emitting diode device. A prototype diode array, comprising 37 AlGaInP diodes cast in epoxy with a diffuser, and driven by a battery pack, was designed and constructed. A pilot study was carried out in five patients with histologically proven Bowen's disease who were referred for PDT with 5-aminolaevulinic acid. They were all treated in the hospital-based dermatology PDT suite such that each received the same level of supervision as patients receiving PDT with nonambulatory light sources. Patients recorded pain levels. In accordance with our usual practice, patients received two treatments at a 4-week interval. Four of five patients were clear at follow-up (range 6-13 months, median 9). Pain was classified as none or mild in 80% of treatments and moderate in the remainder. There are many potential benefits of ambulatory PDT, including the possibility of a much higher patient throughput, and allowing effective treatment at home. This pilot study provides early promising data of the safety and efficacy of this approach.

Catheter- and Antibiotic-Related Complications of Ambulatory Intravenous Antibiotic Therapy for Chronic Refractory Rhinosinusitis

Chronic rhinosinusitis has several features of a prolonged bacterial infection including positive bacterial cultures and abnormal computed tomography findings such as mucosal thickening and hyperostotic bone. Recent studies have suggested that chronic rhinosinusitis may be treated successfully by outpatient parenteral antibiotic treatment (OPAT). In this setting, antibiotics are administered through a peripherally inserted central catheter (PICC). This study evaluates complications arising from OPAT for chronic rhinosinusitis. A chart review was performed of 177 patients who underwent OPAT for chronic rhinosinusitis. PICC line-related infections (4/177, 2%)) included line thrombosis in three patients and septicemia in one patient. In the three patients with line thrombosis, the PICC lines were removed and replaced, allowing for completion of the antibiotic course. Antibiotic complications (29/177, 16%) included four patients with transient neutropenia and one patient with elevated liver function tests. Of the four patients with neutropenia, only one required a change in antibiotics. The patient with elevated liver function tests did not require a change in antibiotics. Minor complications from antimicrobial treatment such as rash, itchiness, flushing, and diarrhea were reported by 25 patients, 9 of these patients required a change in antibiotics. There were no permanent complications or deaths in this study. Intravenous antimicrobial treatment administered through a PICC line in an outpatient setting is well-tolerated for chronic rhinosinusitis. Although PICC line and antibiotic-related complications are relatively infrequent, the physician should be aware of these complications and consider them in selecting patients for OPAT.

Using compensations to assess physical performance for ambulatory outpatients

White LJ, Straube D, Keehn MT. Using compensations to assess physical performance for ambulatory outpatients. Arch Phys Med Rehabil 2004;85:1519–24. Objective To construct a physical performance scale for community-dwelling ambulatory outpatients that is linear, includes high functioning tasks, and uses common compensations to assess difficulty levels. Design Calibrated subject performances on 19 tasks were rated by an examiner, timed, and had compensations recorded. Setting Ambulatory outpatient physical therapy (PT) department of a tertiary care center. Participants Convenience sample of 50 community-dwelling patients with difficulties in mobility referred for PT. Interventions Not applicable. Main outcome measures The Community Ambulatory Physical Performance Scale (CAPPS) constructed by using Rasch analysis, the Lower Extremity Functional Scale (LEFS), and the six-minute walk test (6MWT). Results The CAPPS showed construct validity after removal of 3 items. Two additional items were removed for improved clinical utility. The person reliability was .89 and item reliability was .98. Subjects’ performance on the CAPPS correlated with the 6MWT ( r=.79; 95% confidence interval [CI], .65–.87) and with the LEFS ( r=.62; 95% CI, .40–.78). Conclusions The CAPPS showed good psychometric properties and has utility for assessments of higher-level physical functioning. This standardized approach to performance testing for ambulatory outpatients appears to be a promising method for articulating the compensations persons use to accomplish common tasks. Use of compensatory strategies to assess difficulties in physical performance may assist in delineating interventions directed toward improving task performance.

Serious adverse incidents with the usage of low molecular weight heparins in patients with chronic kidney disease

Background: The aim of the study is to describe serious adverse events in patients with renal insufficiency administered low molecular weight heparins (LMWHs). Methods: Systematic case note review from July 2002 to March 2003, Hope Hospital, Salford, UK, was used. Results: Ten patients experienced an adverse incident on LMWH therapy. Five patients were on maintenance hemodialysis therapy, and 1 patient was on continuous ambulatory peritoneal dialysis therapy. Three patients had calculated creatinine clearances of 5, 11, and 33 mL/min (0.08, 0.18, and 0.55 mL/s), and 1 patient had an estimated glomerular filtration rate of 12 mL/min. Age range was 45 to 89 years. Indications for anticoagulation were suspected pulmonary embolism (1 patient), acute coronary syndrome (7 patients), severe nephrotic syndrome (1 patient), and postoperative venous thromboembolic prophylaxis (1 patient). Three patients also were administered aspirin; 1 patient, clopidogrel; and 3 patients, aspirin and clopidogrel. LMWHs used were enoxaparin (6 patients), tinzaparin (3 patients), and dalteparin sodium (1 patient). Bleeding sources were retroperitoneal (1 patient), spontaneous soft tissue (3 patients), gastrointestinal (2 patients), dialysis catheter and cannula sites (2 patients), hemorrhagic pericardial effusion (1 patient), and intracranial (1 patient). Activated partial thromboplastin time was prolonged in 7 of 10 patients, with no other identifiable cause found. Three patients died despite aggressive resuscitation, including packed red blood cell infusions and protamine sulfate administration. Eight of the 10 prescriptions for LMWHs were either started or continued within our directorate, giving an approximate incidence of major hemorrhagic events in patients with chronic kidney disease of 7.8%. Conclusion: LMWHs administered at fixed-weight doses and without monitoring show unpredictable anticoagulant effects in patients with chronic kidney disease stages 4 and 5, leading to serious and even fatal adverse incidents.