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Transjugular versus percutaneous renal biopsy for the diagnosis of parenchymal disease: comparison of sampling effectiveness and complications.

PURPOSE: To compare the effectiveness and safety of transjugular renal biopsy with those of percutaneous renal biopsy for diagnosis of renal parenchymal disease. MATERIALS AND METHODS: Results and complications of 400 consecutive transjugular renal biopsies performed between 1993 and 1998 with a modified Colapinto transjugular hepatic biopsy system were compared retrospectively with those of 400 percutaneous renal biopsies performed during the same period. Transjugular renal biopsy was associated with 14 cardiac and 35 hepatic biopsies. Number of glomeruli per tissue core, adequacy of tissue core for histopathologic diagnosis, and rate and severity of complications were analyzed. RESULTS: Renal tissue was obtained with percutaneous renal biopsy in 382 (95.5%) of 400 patients and with transjugular renal biopsy in 383 (95.8%) of 400 patients. The mean numbers of intact glomeruli per tissue core with optical microscopy were 11.2 +/- 7.7 (SD) and 9.8 +/- 7.6 for percutaneous renal biopsy and transjugular renal biopsy, respectively. With immunofluorescent microscopy, the mean numbers were 6.4 +/- 5.3 and 4.6 +/- 4.6 for percutaneous renal biopsy and transjugular renal biopsy, respectively. Tissue cores were adequate for histopathologic diagnosis in 98.2% with both techniques. Major complications occurred with transjugular renal biopsy in four patients and with percutaneous renal biopsy in three patients. CONCLUSION: Use of transjugular renal biopsy provides diagnostic yield and safety similar to those of percutaneous renal biopsy and allows multiorgan biopsy during the same procedure. It can be recommended in patients with percutaneous renal biopsy contraindication or failure.

Adult↗

A double-blind, placebo-controlled evaluation of the effect of oral doses of rizatriptan 10 mg on oral contraceptive pharmacokinetics in healthy female volunteers.

Rizatriptan (MAXALT), a potent, oral 5-HT1B/1D agonist with a rapid onset of action, is available now for the acute treatment of migraine. This study examined the pharmacokinetic and clinical interaction between rizatriptan 10 mg and the components (ethinyl estradiol [EE] 35 micrograms and norethindrone [NET] 1.0 mg) of a well-established oral contraceptive combination product, ORTHO-NOVUM 1/35. Levels of sex hormone binding globulin (SHBG), a protein increased by EE to which NET binds, were also examined. In this two-period crossover study, 20 healthy young female subjects received a coadministration of 8 days of rizatriptan treatment (6 days of single-dose 10 mg rizatriptan and 2 days of multiple-dose rizatriptan, 10 mg q 4 hours for three doses, giving a total daily dose of 30 mg on Days 7 and 8) or matching placebo along with their daily dose (one tablet) of ORTHO-NOVUM 1/35 within their oral contraceptive cycle. Plasma was sampled for EE, NET, and SHBG concentrations. Safety evaluations included routine laboratory safety studies, physical examinations, and monitoring for ECG, vital signs, and adverse events. There were no statistically significant differences in any of the pharmacokinetic parameters of EE or NET between the rizatriptan and placebo treatment periods, thus indicating that rizatriptan had no meaningful effect on the disposition of either the EE or the NET component of ORTHO-NOVUM 1/35. The SHBG concentration did not change throughout the entire study. Clinically, coadministration of rizatriptan with ORTHO-NOVUM 1/35 was well tolerated. Blood pressure, heart rate, and temperature showed no consistent trend or clinically important changes. Adverse events following coadministration of rizatriptan with ORTHO-NOVUM 1/35 were similar to those reported when placebo was given with ORTHO-NOVUM 1/35. The findings of this study indicate that there is little potential for dosages as high as 30 mg/day, the maximum recommended dosing schedule, of rizatriptan to alter the plasma concentrations of oral contraceptives.

Administration, Oral↗

A randomized trial of calcium supplementation for childhood lead poisoning.

OBJECTIVE: Lead (Pb) poisoning remains a common disease among children despite successful public health efforts that have reduced its prevalence. Treatment options for children with blood Pb levels (BPbs) <45 micro g/dL are limited because chelation therapy is generally not indicated. Calcium (Ca) and Pb interactions are well documented. Competition for binding to Ca-binding proteins may underlie a mechanism for Pb absorption. The purpose of this study was to determine the role, if any, of supplemental Ca at reducing BPbs in moderately poisoned children. METHODS: Children aged 1 to 6 years with BPbs 10 to 45 micro g/dL were enrolled in a double-blinded, placebo-controlled trial of the effects of Ca supplementation on BPbs. Children received either a Ca-containing liquid or an indistinguishable placebo. Dosage was adjusted biweekly on the basis of responses to a dietary Ca intake questionnaire to reach 1800 mg in the Ca-supplemented group. Samples for BPbs and measures to assess safety were collected before and after 3 months of supplementation and after an additional 3 months of follow-up. Bivariate and multiple regression analyses were performed. RESULTS: A total of 67 of 88 enrolled children with a mean age of 3.6 years completed 3 months of supplementation. There were no statistically significant differences between groups on hematologic and biochemical measures, including serum and urinary Ca, at any time points. The average compliance rate was estimated to be 80% for each group during the 3-month supplementation period. CONCLUSIONS: At enrollment, the average daily Ca intake in this group of inner-city children was greater than the recommended daily intake for age. Although BPbs declined during a 3-month period in both groups, Ca supplementation aimed at providing 1800 mg of Ca/day had no effect on the change in BPbs. Ca supplementation should not be routinely prescribed for mild to moderately Pb-poisoned children who are dietarily Ca sufficient.

Calcium↗

Kitchen scalds and thermal burns in children five years and younger.

OBJECTIVE: The current study was undertaken to describe patterns of kitchen burns and scalds to young children to understand better why such injuries continue to occur despite intervention efforts. METHODS: Emergency department-treated thermal burns and scalds associated with nonelectric cookware were examined from a national sample, collected by the US Consumer Product Safety Commission's injury surveillance system over a 6-year period, 1997-2002. Data extracted from the cases included age, gender, body part, disposition, case weight, causal substance, and injury pattern. Data were analyzed using Epi Info 2002, with significance assessed by chi(2) test. RESULTS: Scalds were approximately twice as common as were thermal burns. Hot water was the chief causal agent for scalds. The 2 most common scald injury patterns were (1) the child reached up and pulled a pot of hot water off the stove or other elevated surface and (2) the child grabbed, overturned, or spilled a container of hot water onto him- or herself. One-year-olds were at highest risk for scalds and thermal burns. Scalds resulted in significantly more hospitalizations than did thermal burns. In nearly all injury patterns, more boys than girls were injured, but the ratio varied depending on the injury pattern. CONCLUSIONS: Although the kitchen is recognized as a room that is hazardous for young children, parents seem not to recognize or anticipate the risk for burns and scalds. The ability of children, especially toddlers, to reach containers of hot liquids on elevated surfaces is reflected in the injury data and is explained by anthropometry data, yet there is an apparent failure on the part of parents to recognize children's ability to gain access to the hazard and a failure to recognize the potential severity of resulting injury. These failures might explain why behavioral interventions (eg, place pots on back burners of stove) have been nonmotivating and ineffective. A multifaceted spectrum of prevention that has individual, community, and organizational components may prove to be more useful.

Accidents, Home↗

A method for measuring low-weight carboxylic acids from biosolid compost.

Concentration of low-weight carboxylic acids (LWCA) is one of the important parameters that should be taken into consideration when compost is applied as soil improver for plant cultivation, because high amounts of LWCA can be toxic to plants. The present work describes a method for analysis of LWCA in compost as a useful tool for monitoring compost quality and safety. The method was tested on compost samples of two different ages: 3 (immature) and 6 (mature) months old. Acids from compost samples were extracted at high pH, filtered, and freeze-dried. The dried sodium salts were derivatized with a sulfuric acid-methanol mixture and concentrations of 11 low-weight fatty acids (C1-C10) were analyzed using headspace gas chromatography. The material was analyzed with two analytical techniques: the external calibration method (tested on 11 LWCA) and the standard addition method (tested only on formic, acetic, propionic, butyric, and iso-butyric acids). The two techniques were compared for efficiency of acids quantification. The method allowed good separation and quantification of a wide range of individual acids with high sensitivity at low concentrations. Detection limit for propionic, butyric, caproic, caprylic, and capric acids was 1 mg kg(-1) compost; for formic, acetic, valeric, enanthoic and pelargonic acids it was 5 mg kg(-1) compost; and for iso-butyric acid it was 10 mg kg(-1) compost. Recovery rates of LWCA were higher in 3-mo-old compost (57-99%) than in 6-mo-old compost (29-45%). In comparison with the external calibration technique the standard addition technique proved to be three to four times more precise for older compost and two times for younger compost. Disadvantages of the standard addition technique are that it is more time demanding and laborious.

Calibration↗

Motivation, stress, and cortisol responses in skydiving.

This study examined metamotivational dominance, metamotivational states, and cortisol responses in skydiving participants. Data were obtained from 23 experienced skydivers 15 min. prior to and following a skydive. Respondents were mainly paratelic-conformist dominant and most occupied the conformist and arousal-seeking states prior to skydiving, assessed respectively, with Apter, et al.'s Motivational Style Profile and Cook, et al.'s measure of metamotivational states. Paratelic-conformist dominance indicates a predisposition towards conformity and a desire to be spontaneous, and the conformist and arousal seeking states reported prior to completing the skydive represent a desire to conform to expected norms but also to seek arousal. There was no significant change in scores for metamotivational state or stress following skydiving. Contrary to expectations, cortisol level prior to skydiving was negatively associated with external stress. These results support the paratelic, but not the negativistic, dominance found in previous samples of risk sport participants (no skydivers). The conformist dominance and pre-dive conformist metamotivational state scores of this sample may be fundamental for adhering to safety regulations imposed on skydivers. To obtain better understanding of this phenomenon, researchers should attempt to measure these variables during, rather than prior to and after, participation in risk sports.

Adult↗

A new diagnostic method for the detection of endogenous Rous-associated virus-type provirus in chickens.

A quick and simple method has been developed to detect the presence or absence of the endogenous Rous-associated virus (RAV) element ev1 in chickens. The procedure consists of a one-tube multiplex polymerase chain reaction (PCR) involving three oligonucleotide primers that are specific for the upstream flanking region, the long terminal repeat (LTR), and the downstream flanking region of the proviral insert, respectively. The multiplex reaction allows for the unambiguous discrimination between ev1+/ev1+ homozygote, ev1-/ev1- homozygote, and ev1+/ev1- heterozygote birds. The method works best with purified genomic DNA as substrate, but can also be used with rapidly prepared, "crude" DNA samples. The combination of speed with the safety of a nonradioactive procedure, and the ability to perform large numbers of assays by a semi-automated procedure, make this method attractive for large-scale screening projects. The ev1 locus has been used as a model system to demonstrate the feasibility of the PCR diagnostic approach. However the same principle should be applicable to the analysis of other RAV-type ev loci, as well as endogenous elements belonging to other families of viruses as sequence information for the flanking regions of these inserts becomes available.

Animals↗

Medication monitoring in the elderly.

OBJECTIVE: To review changes associated with aging that affect medication use and to outline medication-monitoring guidelines. DATA SOURCES: Recent medical literature including journals and texts. STUDY SELECTION: Determined by the author. DATA EXTRACTION: By the author. DATA SYNTHESIS: There are many changes that occur in the aging individual that may affect medication use. Alterations in organ function, especially that of the liver and kidneys, may potentiate drug effects. Appropriate use of serum-drug concentrations, used in conjunction with standard clinical observations, is an effective means of monitoring the patient. Medications with a high risk of toxicity in the elderly, such as phenytoin, theophylline, and digoxin, may be used with a much higher degree of safety if serum concentrations are obtained. Blood samples must be obtained at appropriate times to ensure accurate interpretation of the drug concentration. CONCLUSION: When performed appropriately, serum-concentration monitoring of medications is a valuable method of reducing toxicity in the elderly.

Age Factors↗

Impediments to achieving health for all in Kenya by the year 2000: indicators from Nyanza Province.

The paper presents a situation analysis of the adoption of primary health care (PHC) in Nyanza province, a rural Kenyan community, and how close the level of health is gaining on the WHO target of Health for all by the year 2000. Empirical data from 219 households were collected through interviews, observation, taking samples of drinking water, and compiling meal composition. Descriptive statistics and Student's t-test were used to analyse the relationship between the level of adoption of certain PHC elements and morbidity prevalence. Sampled drinking water was chemically tested for safety, while meal composition was analysed for the nutritional adequacy of their mix. Findings reveal that unsafe water and poor sanitation, low immunization coverage, close birth interval, together with inadequate food supply and the subsequent poor nutritional performance, have significantly contributed to the high prevalence of illness. These factors have acted in synergy to produce and sustain the observed low level of health, a level that may make ' health for all' continue to recede further into the horizon even by, and after the year 2000. This is particularly so because the present health education fora are not sufficiently penetrating the family health care providers.

Journal Article↗

Management of treatment refractory attention-deficit/hyperactivity disorder in children and adolescents.

Psychostimulants are the first-line treatment for attention-deficit/hyperactivity disorder (ADHD) in children and adolescents. A minimum of two psychostimulant trials should be instituted before a child's symptoms of ADHD are considered treatment refractory. Clinical issues of diagnostic accuracy, comorbid disorders, psychosocial factors, medication compliance, symptoms across settings, and behavioral treatment should be addressed before initiating alternative medication trials. With the exception of tricyclic antidepressants, there is a paucity of controlled studies with adequate sample size to support the efficacy and safety of nonstimulant medications for the treatment of childhood ADHD. In this article, data on medications for treatment refractory ADHD in children and adolescents are presented and treatment strategies are discussed.

Adolescent↗

Biodistribution and imaging with (123)I-ADAM: a serotonin transporter imaging agent.

UNLABELLED: 2-((2-((Dimethylamino)methyl)phenyl)thio)-5-(123)I-iodophenylamine ((123)I-ADAM) is a new radiopharmaceutical that selectively binds the central nervous system serotonin transporters. The purpose of this study was to measure its whole-body biokinetics and estimate its radiation dosimetry in healthy human volunteers. The study was conducted within a regulatory framework that required its pharmacologic safety to be assessed simultaneously. METHODS: The sample included 7 subjects ranging in age from 22 to 54 y old. An average of 12.7 whole-body scans were acquired sequentially on a dual-head camera for up to 50 h after the intravenous administration of 185 MBq (5 mCi) (123)I-ADAM. The fraction of the administered dose in 13 regions of interest (ROIs) was quantified from the attenuation-corrected geometric mean counts in conjugate views. Multiexponential functions were iteratively fit to each time-activity curve using a nonlinear, least-squares regression algorithm. These curves were numerically integrated to yield source organ residence times. Gender-specific radiation doses were then estimated with the MIRD technique. SPECT brain scans obtained 3 h after injection were evaluated using an ROI analysis to determine the range of values for the region to cerebellum. RESULTS: There were no pharmacologic effects of the radiotracer on any of the subjects, including no change in heart rate, blood pressure, or laboratory results. Early planar images showed differentially increased activity in the lungs. SPECT images demonstrated that the radiopharmaceutical localized in the midbrain in a distribution that is consistent with selective transporter binding. The dose-limiting organ in both men and women was the distal colon, which received an average of 0.12 mGy/MBq (0.43 rad/mCi) (range, 0.098-0.15 mGy/MBq). The effective dose equivalent and effective dose for (123)I-ADAM were 0.037 +/- 0.003 mSv/MBq and 0.036 +/- 0.003 mSv/MBq, respectively. The mean adult male value of effective dose for (123)I-ADAM is similar in magnitude to that of (111)In-diethylenetriaminepentaacetic acid (0.035 mGy/MBq), half that of (111)In-pentetreotide (0.81 mGy/MBq), and approximately twice that of (123)I-inosine 5'-monophosphate (0.018 mGy/MBq). The differences in results between this study and a previous publication are most likely due to several factors, the most prominent being this dataset used attenuation correction of the scintigraphic data. Region-to-cerebellum ratios for the brain SPECT scans were 1.95 +/- 0.13 for the midbrain, 1.27 +/- 0.10 for the medial temporal regions, and 1.11 +/- 0.07 for the striatum. CONCLUSION: (123)I-ADAM may be a safe and effective radiotracer for imaging serotonin transporters in the brain and the body.

Adult↗

Sample size in occupational mortality studies.

In 1980, the Occupational Safety and Health Administration asserted that "non-positive human studies" would be considered in reviews of evidence only if in a study the "group of exposed subjects was large enough for an increase in cancer incidence of 50% above that in unexposed controls to have been detected at any of the predicted sites." The concepts of statistical testing and power in occupational mortality studies are reviewed, and studies published in two prominent occupational health journals in 1979 and 1980 are analyzed in terms of their power. A large proportion of standardized mortality ratio studies have a low probability of detection of relative risks of the order of 1.5.

Epidemiologic Methods↗

The natural connection: the clinical nurse specialist and bedside nursing research.

The educational preparation and consistent clinical focus of CNSs position them ideally for conducting research at the bedside and helping staff nurses see the relevance of such research. Our research studies have identified a new category of clinical nursing research termed bedside nursing research. Like its parent category of clinical nursing research, the function of bedside nursing research is to generate new knowledge or validate and expand previously generated knowledge. Characteristics that distinguish bedside nursing research from other forms of clinical nursing research are: focus, idea stimulus and setting, originator of the research question, relationship with theory, sensitivity to changing technology in health care, and impact on nursing practice. To illustrate the nature and outcome of this type of research, we describe three bedside nursing research studies conducted by CNSs in a pediatric oncology setting. These studies assessed: (1) the effects of chest tube stripping on the incidence of pain, fever, and pulmonary complications; (2) the relative safety and efficacy of techniques for blood sampling from Hickman catheters; and (3) the effects of infusion method on quality and survival of transfused platelets. The impact of these studies of hospital practices is reviewed.

Clinical Nursing Research↗

One year efficacy and tolerability of clonidine administered by the transdermal route in patients with mild to moderate essential hypertension--a multicentre open label study. The Antihypertensive Patch Italian Study (APIS) Investigators.

The clonidine patch offers for the first time the unique possibility of a once-a-week transdermal therapy of hypertension due to direct absorption of clonidine through the skin. The present study investigates the efficacy and safety of the transdermal administration on a sample of the Italian population. 101 patients entered the study, 51 male, 50 female (mean age: 53 years, SD +/- 10; range: 30-71 years), they were given clonidine by a therapeutical transdermal system as starting dosage. If blood pressure was not adequately controlled (DBP < 90 or 10 mmHg decreased from baseline value) the dosage was increased on a 2 week basis assessment. The patients were then followed for 12 months after the start of treatment. The decrease in both systolic and diastolic blood pressure continued up to one month after start of treatment and remained constant for at least 9 months. A total of 70% of the patients were controlled by the antihypertensive treatment as monotherapy, while in 6% additional combination with a diuretic lead to blood pressure control. 5% of the patients showed no reduction in blood pressure at the end of the titration phase. 24 (23%) patients complained of skin reaction; 21 patients of these (ten male, eleven female) were withdrawn from the trial due to predefined skin reaction criteria. No serious side effects have been observed during the run of the study. No rebound phenomena occurred in the week after treatment discontinuation. It is concluded that the transdermal treatment of hypertension with a clonidine containing transdermal system is therapeutically effective and probably associated with a high acceptability and increased compliance.

Administration, Cutaneous↗

Endometrial biopsy.

Endometrial biopsy is an important diagnostic tool for the evaluation of infertility and abnormal uterine bleeding. The documented safety and accuracy of the plastic endometrial sampling devices have made them popular for use in the office. The procedure requires limited equipment and supplies, and it is generally well tolerated without anesthesia. The pathology report can guide the treatment of benign lesions, including simple hyperplasia. The finding of cytologic atypia indicates a significant risk of progression to carcinoma, and hysterectomy should be considered. If symptoms persist despite a normal endometrial biopsy, further evaluation is recommended.

Biopsy↗

Biodistribution and dosimetry of TRODAT-1: a technetium-99m tropane for imaging dopamine transporters.

UNLABELLED: Technetium-99m TRODAT-1 is an analog of cocaine that selectively binds the presynaptic dopamine transporters. The primary purpose of this study was to measure its whole-body biokinetics and radiation dosimetry in healthy human volunteers. The study was conducted within a regulatory framework that required its pharmacological safety to be assessed simultaneously. METHODS: The sample included 4 men and 6 women ranging in age from 22-54 yr. An average of 20 whole-body scans were acquired sequentially on a dual-head camera for up to 46 hr after the intravenous administration of 370+/-16 MBq (10.0+/-0.42 mCi) 99mTc TRODAT. The renal excretion fractions were measured from 12-24 discrete urine specimens. The fraction of the administered dose in 17 regions of interest and each urine specimen was quantified from the attenuation and background corrected geometric mean counts in conjugate views. Multiexponential functions were iteratively fit to each time-activity curve using a nonlinear, least squares regression algorithm. These curves were numerically integrated to yield source organ residence times. Gender-specific radiation doses were then estimated with the Medical Internal Radiation Dose technique for each subject individually before any results were averaged. RESULTS: There were no pharmacological effects of the radiotracer on any of the subjects. The early planar images showed differentially increased activity in the nose, pudendum and stomach. SPECT images demonstrated that the radiopharmaceutical localized in the basal ganglia in a distribution that was consistent with selective transporter binding. Image analysis showed that the kidneys excreted between 20% and 32% of the injected dose during the first 22-28 hr postadministration, after which no more activity could be recovered in the urine. The dose limiting organ in both men and women was the liver, which received an average of 0.046 mGy/MBq (0.17 rads/mCi, range 0.14-0.22 rad/mCi). In the worst case, which was clearly an over-estimation, it would have taken 22.7 mCi to deliver 5 rad to the liver. CONCLUSION: TRODAT may be a safe and effective radiotracer for imaging dopamine transporters in the brain and the body.

Adult↗

Automobile passenger safety education for pregnant women and infants. Attitudes and practices of obstetrician-gynecologists.

Attitudes and practices regarding automobile passenger safety education for pregnant women and infants were surveyed in a random sample of 236 certified obstetrician-gynecologists in California. A majority of respondents stated that maternal passenger safety (71.6%) and infant/child passenger safety (63.6%) should be "routinely discussed by the obstetrician-gynecologist during the prenatal period." Nevertheless, one of four respondents could not give an opinion or had doubts about the safety of seat belt use in pregnant women. Fewer than one of three discussed maternal passenger safety, and fewer than one of four discussed infant/child passenger safety when giving prenatal care. There was a scarcity of patient education materials in the practitioners' offices. Given the obstetrician-gynecologists' support for promoting passenger safety, there is need for increased health education activities in offices, clinics, hospitals and prenatal classes.

Accident Prevention↗

Factors associated with in-hospital mortality after administration of thrombolysis in acute ischemic stroke patients: an analysis of the nationwide inpatient sample 1999 to 2002.

BACKGROUND AND PURPOSE: The prospective trials evaluating the safety and efficacy of intravenous tissue plasminogen activator have generally been conducted at academic medical centers and community hospitals with an institutional commitment to stroke care. Relatively little is known about the safety of this therapy as it is used in the community. We therefore examined outcomes in acute stroke patients treated with thrombolysis using the largest discharge database available in the United States for the years 1999 to 2002. METHODS: Data were derived from the Nationwide Inpatient Sample for the years 1999 to 2002. Using the appropriate International Classification of Disease-Clinical Modification, 9th revision, codes, patients admitted through the emergency room with a primary diagnosis of acute ischemic stroke were selected for analysis. From these patients, those coded as receiving thrombolysis were identified. Multivariate logistic regression was performed on the thrombolysis and nonthrombolysis cohorts to identify independent predictors of in-hospital mortality from among those clinical elements available in the database. RESULTS: We identified 2594 patients treated with thrombolysis from a group of 248,964 patients admitted through the emergency room with a primary diagnosis of acute ischemic stroke. The thrombolysis cohort had a higher in-hospital mortality rate compared with the nonthrombolysis patients (11.4% versus 6.8%). The rate of intracerebral hemorrhage was 4.4% for the thrombolysis cohort and 0.4% for nonthrombolysis patients. Multivariate logistic regression showed advanced age, Asian/Pacific Islander race, congestive heart failure, and atrial fibrillation/flutter to be independent predictors of in-hospital mortality after thrombolysis. Thrombolysis volume, overall ischemic stroke volume, and teaching status were not significant predictors of in-hospital mortality after thrombolysis. CONCLUSIONS: Thrombolysis, as it is used in the community, has a safety profile that is similar to that observed in the large, prospective clinical trials.

Adult↗