bluuebunny/crossref_metadata_2025 huggingface dataset:
Empirical Validation of Risk Screening for Down's Syndrome
Authors: Wald N J , Hackshaw A K , Huttly W , Kennard A
Published: January 2017

Objective—

To validate individual risk estimates in antenatal serum screening for Down's syndrome.

Methods—

Women screened for Down's syndrome using maternal serum a fetoprotein (AFP), unconjugated oestriol (uE3), and human chorionic gonadotrophs (hCG) with maternal age (the triple test) or AFP, uE3, free β subunit and free a subunit of hCG with maternal age (the quadruple test) were grouped according to their predicted risk of having an affected pregnancy. The mean predicted risk in each category was then compared with the observed prevalence based on the number of affected and unaffected pregnancies in each category.

Subjects—

About 100 000 pregnant women screened for Down's syndrome from 1989 to 1995.

Results—

There was close agreement between the predicted term risk and the prevalence at birth for both the triple test and the quadruple test. For example, with the quadruple test the predicted risk in the highest risk group was 1 in 3.3 and the prevalence was 1 in 2.6; in the lowest risk group these were 1 in 3000 and 1 in 2300 respectively.

Conclusion—

Risk estimates based on multiple marker screening for Down's syndrome are accurate. The technique used to demonstrate this is simple and offers a useful empirical check on screening performance.
Reasons for Cervical Cancer despite Extensive Screening
Authors: Stenkvist B , Söderström J
Published: January 2017

Objective—

To explain an age adjusted incidence rate of cervical cancer of 10.1 and 10.5 per 100 000 women, despite extensive screening.

Setting—

The Swedish county of Gävleborg in 1986 and 1987.

Methods—

Thirty eight patients with “cervical cancer” reported to the central cancer registry in Sweden were investigated. The patients and their diagnoses were scrutinised in a double blind manner.

Results—

Eighteen per cent (7/38) of cases were shown to be mistakes in data transfer; 11% (4/38) of cases were endocervical adenocarcinomas; 13% (5/38) were histopathological misinterpretations and should have been reported as carcinoma in situ. Of the remaining 22 patients with invasive squamous cancer, 12 (55%) had not participated in the gynaecological health control programme. Of the 10 participants with invasive squamous cancer despite this participation, eight (80%) had repeatedly had abnormal Papanicolaou smears without further gynaecological/histopathological examination and treatment. There was no evidence of cases of carcinoma in situ or endometrial cancer diagnosed in 1986–87 being squamous cervix cancer. The true incidence of squamous cervical cancer among participants was 3.0 per 100 000 for the two years scrutinised. If all the patients with Papanicolaou smear abnormalities had been properly managed at the right time, and the treatment had been successful, the incidence of invasive squamous cancer would have been 0.8 per 100 000 women among participants as opposed to 38.2 per 100 000 among non-participants.

Conclusion—

The evidence strongly suggests overascertainment of cervical cancer, which conceals the success of screening, and also suggests that much attention must be given to clinical management of detected lesions in cervical screening. Care is needed in applying accurate histopathological criteria when making a diagnosis of invasive squamous cancer, to separate squamous cancer from other malignant tumours of the cervix, and in data transfer to cancer registries.
Co-Morbidity in Patients with Abdominal Aortic Aneurysm
Authors: Kanagasabay Robin , Gajraj Haroun , Pointon Linda , Scott R Alan P
Published: January 2017

Objectives—

Selection for surgery of patients with abdominal aortic aneurysm (AAA) depends on an assessment of risk from operation compared with risk from aneurysm rupture. A study was performed to assess the levels of co-morbidity and to see whether co-morbidity was different in people with a normal aorta after ultrasonographic examination than in those with an aneurysmal aorta.

Setting and methods—

Over a two year period 5392 people (2341 men, 3051 women) aged 65–80 were screened using B-mode linear ultrasound, with maximum measurements taken of transverse, anteroposterior diameters, or both. All subjects were given a questionnaire seeking a history of angina, stroke, claudication, myocardial infarct, respiratory problems, and diabetes.

Results—

218 men and women were found to have an AAA of 3 cm or greater. The results of the questionnaire were analysed using logistic regression whereby all the co-morbid conditions were adjusted for each other and for smoking, sex, and age. The only conditions which were significantly associated with AAA in both sexes were myocardial infarction with an odds ratio(OR) of 1.66 (95% confidence interval (CI) 1.06 to 2.60) and claudication with an OR of 1.68 (95% CI 1.17 to 2.42). The association between angina and AAA was of borderline significance (OR = 1.52, 95% CI 1.00 to 2.30). Stroke was significantly associated only in women, with an OR of 3.71 (95% CI 1.42 to 9.69). Rates of diabetes and respiratory disease were not significantly different between people with AAA and normal aortas.
Screening for Cutaneous Malignant Melanoma: A Feasibility Study
Authors: Törnberg Sven , Månsson-Brahme Eva , Linden Diana , Ringborg Ulrik , Krakau Ingvar , Karnell Ruth , Landegren Johan , Brandberg Yvonne , Hakulinen Timo
Published: January 2017

Objectives—

To study two different procedures for inviting subjects to screening for malignant melanoma, and to study the role of specially trained nurses as primary examiners.

Methods—

The study was carried out in Stockholm county and comprised 5000 randomly selected men and women aged 40 to 60, of whom 2500 were invited with a personal invitation letter and with a set time of appointment and 2500 were sent a questionnaire and instructions for self examination of the skin. To test the nurses' competence, a survey was made, comparing the judgments of skin examination between nurses and doctors.

Results—

1654 (66%) of those invited for a skin examination took part. 1507 (60%) replied in the questionnaire group, of whom 1024 (41%) requested and attended a subsequent skin examination. Of the subjects attending from both groups, the nurses judged 9% v 11% as having skin lesions suggesting malignant melanoma, whereas the two doctors referred 4% v 3% of the subjects for surgical biopsy. Two malignant melanomas were detected, both of them in the questionnaire group. In the study of nurses' screening competence, both nurses and doctors equally judged one case out of 19 as having a lesion suspicious for malignant melanoma.

Conclusions—

When the questionnaire method was used the results were achieved with one third fewer skin examinations, but it is difficult to conclude whether one of the procedures is better than the other. The results also indicate that nurses can be trained to be the primary examiners in a melanoma screening programme.
The Coming Energy Revolution and the Transformation of the International Political Economy: Fuel Cell Technology, Public Policy and Global Power Shifts
Authors: Talalay Michael
Published: January 2017

This paper addresses the issue of technological change in the global political economy. Specifically, it looks at the implications of a transition from hydro-carbons to hydrogen-powered fuel cells as the major source of energy for transportation, for electricity generation, and for combined heat and power. After briefly explaining how fuel cells work and what their direct benefits are, including dramatically reducing air pollution and global warming and shifting from fossil fuels to renewable energy, the paper asks three main questions. First, what are the political, economic and technical obstacles that fuel cells must overcome. Second, what combination of market pull and public policy push will lead to their commercial success. Third, what are the implications of such success for the global political economy in three areas: changes in competitiveness in major industries; economic growth and development; and the global redistribution of political power.
The Ghost of Wesley Vale: Environmentalists' Influence on Innovation in Australia's Pulp and Paper Industry
Authors: Sonnenfeld David A.
Published: January 2017

This paper analyzes how a key conflict in Australia's pulp and paper industry became generalized to other sites through environmental action, government regulation, and industry initiative. From 1987–91, Australians debated construction of a new, world-class, export-oriented pulp mill in Tasmania. Rural residents, fishermen, and environmentalists, allied with the Australian Labor Party, succeeded in scuttling the project. Subsequently, the national government launched a major research program, state governments tightened regulations, and industry reduced elemental chlorine use. Any new mills constructed in Australia today would be among the cleanest in the world. This paper is part of a larger, comparative study of technological innovation in the pulp and paper industries of Australia, Indonesia, Malaysia, and Thailand. The author interviewed industry officials, government regulators, research scientists, and environmentalists; visited pulp and paper mills; attended technical conferences; and conducted archival work in these countries during a 12-month period.
Global Commodity Chains: New Forms of Coordination and Control among Nations and Firms in International Industries
Authors: Gereffi Gary
Published: January 2017

This article builds on Whitley's comparison of the business systems and global commodity chains approaches to the study of economic organization within and across nations and regions. My objective is to provide a fuller exposition of the logic and evidence underlying the emergence, evolution, and variation in buyer-driven and producer-driven commodity chains. While there are clearly national differences within commodity chains, the idea that nations matter more than industrial sectors in generating contrasting forms of economic organization in global capitalism remains debatable. One of the central propositions of the commodity chains perspective is that globalization tends to diminish the influence of national origins on business systems. The way firms do business in the international economy thus is determined to an increasing extent by their position in global commodity chains, not their national origins. Nonetheless, because they highlight different units and levels of analysis, the business systems and commodity chains approaches are best viewed as complementary (rather than competing) theoretical frameworks.
Political Economy and the Social Organisation of Economic Activity: A Synthesis of Neo-Institutional and Labour Process Analyses
Authors: Warhurst Chris
Published: January 2017

This article accepts that neo-institutionalist analysis is an important development in providing a framework for understanding the social organisation of economic activity within firms. However, it is argued that neo-institutionalism ignores political economy and an important institution – the market – within capitalist political economy such that the framework of analysis so far offered is inadequate. It is suggested that an understanding of that organisation would benefit from an incorporation of labour process analysis as the latter is explicit in arguing that the social organisation of economic activity cannot be decoupled from political economy and, hence with regard to capitalism, the effects of the market. For the sake of simplicity, the introduction maps out the general argument and subsequent sections of the article offer outlines and then evaluations of both forms of analysis separately before prosecuting a synthesis of the two.
The diagnostic accuracy of the Kimberley Indigenous Cognitive Assessment (KICA) tool: a systematic review
Authors: Dyer Suzanne M , Laver Kate , Friel Margeret , Whitehead Craig , Crotty Maria
Published: January 2017

Objectives:

The objective of this study was to conduct a systematic review of evidence for the accuracy of the Kimberley Indigenous Cognitive Assessment (KICA) tool in supporting the diagnosis of dementia in Indigenous Australian populations.

Methods:

Cross-sectional diagnostic accuracy studies of the KICA with an appropriate reference standard published to November 2015 were included. Comparison to an alternative cognitive assessment tool was required in non-remote populations. Case control analyses were excluded.

Results:

Four studies were included: one of the KICA-Cog and KICA-Carer, one of the KICA Screen, and two of the modified-KICA. All tools developed for remote populations had a sensitivity of ≥76% and a specificity of ≥71% for the diagnosis of dementia. The KICA-Cog and KICA-Carer conducted in series had the highest sensitivity and specificity (91% and 94% respectively). In an urban and regional population, the mKICA had similar accuracy to the Mini-Mental State Examination (MMSE) (AUC 0.93, 95% CI 0.88–0.99 vs 0.94, 95% CI 0.89–0.99). Key risk of bias limitations related to lack of pre-determined cut-points and population selection methods.

Conclusion:

The use of the KICA in remote Indigenous Australians may assist in timely diagnosis of dementia in this population. Using the KICA-Cog and KICA-Carer in series may maximise specificity, decreasing false positive results without compromising sensitivity.
Work–life balance and welfare
Authors: Evans Lois , Young Greg
Published: January 2017

Objectives:

An online survey and focus groups were conducted, providing qualitative information on the work–life balance of psychiatrists and trainees in Australasia.

Methods:

An invitation to participate in an anonymous online welfare survey was emailed to all the Royal Australian and New Zealand College of Psychiatrists trainees, Fellows, and Affiliates. Following this, nine focus groups were held across Australia and New Zealand.

Results:

Responses received were thematically analysed. The emergent patterns are presented in this report.

Conclusions:

Our research suggests that work–life balance can be subjectively and objectively measured. There are phases of good and bad work–life balance, depending on stage of career and other commitments. Work–life balance may be an indicator of the health of individuals and organisations. Due to its complexity, with intrinsic and extrinsic factors involved, solutions are unlikely to be simple. Further studies are needed to substantiate our findings.
Self-powered active control of elastic and aeroelastic oscillations using piezoelectric material
Authors: Silva Tarcísio Marinelli Pereira , De Marqui Carlos
Published: January 2017

Piezoelectric materials have been used as sensors and actuators in vibration control problems. Recently, the use of piezoelectric transduction in vibration-based energy harvesting has received great attention. In this article, the self-powered active vibration control of multilayered structures that contain both power generation and actuation capabilities with one piezoceramic layer for scavenging energy and sensing, another one for actuation, and a central substructure is investigated. The piezoaeroelastic finite element modeling is presented as a combination of an electromechanically coupled finite element model and an unsteady aerodynamic model. An electrical circuit that calculates the control signal based on the electrical output of the sensing piezoelectric layer and simultaneously energy harvesting capabilities is presented. The actuation energy is fully supplied by the harvested energy, which also powers active elements of the circuit. First, the numerical predictions for the self-powered active vibration attenuation of an electromechanically coupled beam under harmonic base excitation are experimentally verified. Then, the performance of the self-powered active controller is compared to the performance of a conventional active controller in another base excitation problem. Later, the self-powered active system is employed to damp flutter oscillations of a plate-like wing.
Clinical Pharmacist Management of Bacteremia in a Community Hospital Emergency Department
Authors: Waters C. Dustin , Bitton Bryce J. , Torosyan Annie , Myers Kevin P.
Published: January 2017

Background: Bacteremia is a serious condition that leads to high morbidity and mortality. Data describing pharmacist involvement in the management of bacteremia in the emergency department are lacking. Objective: To determine if pharmacist involvement in the management of bacteremia in the emergency department (ED) led to an increase in appropriate treatment of bacteremia as well as improvements in patient outcomes. Methods: The primary outcome of this retrospective cohort study was the rate of appropriate treatment of bacteremia. Secondary outcomes included the rate of unplanned, infectious disease–related 90-day admission or readmission to the ED or hospital as well as infectious disease–related 90-day mortality. All patients seen in the ED and subsequently discharged who had a positive blood culture determined not to be a contaminant were included in the study. Patients were analyzed in 2 cohorts: those that were physician managed (107 patients) and those that were pharmacist managed (138 patients). Results: In the physician-managed cohort, 50 of 107 (47%) patients were treated appropriately compared with 131 of 138 (95%) patients in the pharmacist-managed cohort ( P < 0.0001). There was also a decrease in attributable 90-day admission or readmission in pharmacist-managed patients, which occurred in 4 of 138 patients (2.9%) versus the physician-managed patient cohort in which 13 of 107 patients (12.1%) were readmitted ( P = 0.01). There was no difference in mortality between the groups ( P = 0.8337). Conclusion: Pharmacist involvement in the management of bacteremia in the ED was associated with higher rates of appropriate treatment and a corresponding decrease in the rates of attributable 90-day admission or readmission to the hospital or ED.
Dose-Ranging Pharmacokinetic Study of Ciprofloxacin after 200-, 300-, and 400-mg Intravenous Doses
Authors: Nix David E. , Spivey J. Michael , Norman Allyn , Schentag Jerome J.
Published: January 2017

OBJECTIVE:

To assess the pharmacokinetics and tolerance of ciprofloxacin after the administration of single intravenous doses of 200, 300, and 400 mg.

DESIGN:

Double-blind, three-period, randomized, crossover trial.

SETTING:

Private, university-affiliated, hospital-based, clinical research center.

PATIENTS:

Normal healthy male volunteers, 18–40 years of age.

INTERVENTIONS:

Subjects received 200-, 300-, and 400-mg single intravenous doses of ciprofloxacin via 30-minute infusions in random sequence.

MAIN OUTCOME MEASURES:

Serum ciprofloxacin concentrations were determined by HPLC after each dose and the results were used to derive pharmacokinetic parameters. Tolerance was assessed by reported and observed adverse events, urine microscopic examinations for crystals, and examination of intravenous infusion sites.

RESULTS:

The mean area under the time curve (AUC) values displayed linearity with respect to the administered dose. No statistical differences were observed in total body clearance, steady-state volume of distribution, or elimination half-life with respect to dose administered. The mean total body clearance, steady-state volume of distribution, or elimination half-life ranged from 36 to 41 L/h, 146 to 169 L, and 3.5 to 3.7 h for the 200-, 300-, and 400-mg doses, respectively. Adverse effects, including venous irritation (four subjects) and crystalluria (two subjects), were mild and did not require withdrawal of any subject from the study.

CONCLUSIONS:

Intravenous ciprofloxacin in doses ranging from 200 to 400 mg demonstrated linear pharmacokinetics. These single doses were well tolerated, although cases of transient venous irritation and crystalluria were observed.
Effect of the Mode of Lipid Administration on Parenteral Nutrition-Related Infections
Authors: D'Angio Richard G. , Riechers Karen C. , Gilsdorf Robert B. , Constantino John M.
Published: January 2017

OBJECTIVE:

To determine if total nutrient admixtures (TNAs) influence the rate of infection in clinical practice.

DESIGN:

Prospective, randomized trial.

SETTING:

Department of Veterans Affairs Medical Center.

PATIENTS:

All patients were administered parenteral nutrition (PN) via a central venous catheter and received daily lipids.

INTERVENTION:

Patients were randomized as to the mode of administration of lipids. Lipids were either administered with other PN components in a TNA or were piggybacked (PB) into the PN solution.

MAIN OUTCOME MEASURES:

Treatment groups were compared for the rate of occurrence of PN-related infections. Infections were classified as catheter infections or catheter sepsis.

RESULTS:

Ninety-eight patients were entered into the trial. Data from % patients (44 TNA, 52 PB) were available for analysis. Treatment groups were well matched for age, baseline albumin, days of PN, predicted basal metabolic rate, and calorie and protein requirements. TNA patients received a significantly greater percentage of nonprotein calories as lipid. The incidence of infection was 12.6 and 10.3 per 1000 days of PN in the TNA and PB groups, respectively (p=0.89). The microorganisms responsible for infection and the type of infections that developed were similar in both groups.

CONCLUSIONS:

Use of TNAs does not influence the rate of infection in patients receiving PN.
Generalized Seizures Secondary to High-Dose Busulfan Therapy
Authors: Murphy Christopher P. , Harden Elizabeth A. , Thompson James M.
Published: January 2017

Two patients without prior histories of neurologic disorders experienced generalized seizures while receiving high-dose busulfan (total dose 16 mg/kg) as part of a preparative regimen for allogeneic bone marrow transplantation. A review of the literature revealed 14 similar occurrences. Maintenance of therapeutic blood concentrations of Phenytoin in subsequent patients at our institution has resulted in no further patients experiencing generalized seizures. Prophylactic anticonvulsant therapy should be considered in patients receiving high doses of busulfan.
High-Dose Intravenous Immune Globulin in the Management of Severe Guillain-Barre Syndrome
Authors: Urtasun Miguel , de Murrain Adolfo López , Carrera Nieves , Martí-Massó José F. , de Dicastillo Gonzalo López , Mozo Carmela
Published: January 2017

OBJECTIVE:

To evaluate the efficacy of high-dose intravenous gammaglobulin (IGIV) versus plasmapheresis in patients with severe Guillain-Barré syndrome (GBS) and compare the costs of both treatments.

DESIGN:

Retrospective review of all severely disabled GBS patients admitted between January 1 and December 31, 1990.

SETTING:

Neurologic unit of a tertiary-care center.

PATIENTS:

Six patients fulfilling the criteria for the diagnosis of GBS agreed upon by the ad hoc National Institute of Neurological and Communicative Disorders and Stroke committee.

INTERVENTION:

Four patients treated with plasmapheresis underwent three to six sessions of plasma exchange. Two patients received IGIV 0.4 g/kg/d administered over a five-day period.

MAIN OUTCOME MEASURES:

Recovery time, functional assessment (performed according to the grading scale used in the North American trial) at 30, 60, and 90 days after treatment. Cost of plasmapheresis, IGIV, and bed/day were compared.

RESULTS:

Clinical recovery appeared to be faster and more complete in the IGIV group than in the plasmapheresis group. No adverse reactions related to IGIV treatment appeared. The total cost was greater in the plasmapheresis group.

CONCLUSIONS:

These preliminary results suggest that IGIV may be more beneficial and less expensive than plasmapheresis in treatment of GBS. Definitive conclusions regarding the efficacy of IGIV in GBS will need to await the final analysis of the Ducht randomized multicenter trial comparing IGIV with plasmapheresis.
Nephrotoxicity of Contrast Media following Cardiac Angiography: Pathogenesis, Clinical Course, and Preventive Measures, Including the Role of Low-Osmolality Contrast Media
Authors: Spinier Sarah A. , Goldfarb Stanley
Published: January 2017

OBJECTIVE:

To review the incidence, definition, clinical course, risk factors, pathogenesis and prevention of contrast-associated nephropathy (CAN) following cardiac angiography with emphasis on differences between high-osmolality contrast media (HOCM) and low-osmolality contrast media (LOCM).

DATA SOURCES:

Investigations in animal models and in patients following cardiac angiography.

DATA EXTRACTION:

Animal models of the pathogenesis of CAN are presented. Human studies describing the incidence, clinical course, risk factors, and prevention of CAN are reviewed. Comparative clinical trials of HOCM (diatrizoate, metrizoate) and LOCM (iohexol, iopamidol, ioxaglate) nephrotoxicity following cardiac angiography are critically evaluated.

DATA SYNTHESIS:

All clinical studies comparing CAN of HOCM versus LOCM following cardiac angiography have some methodologic limitations (e.g., small sample size, lack of control for other factors) that may affect renal function, lack of stratification for other reported risk factors, and variable or short follow-up periods.

CONCLUSIONS:

Whether the incidence of CAN following cardiac angiography is reduced with LOCM remains controversial. The incidence of CAN in patients with normal renal function does not appear to differ in patients treated with LOCM versus HOCM because few patients in each group develop renal failure. Additional controlled clinical trials comparing CAN of LOCM and HOCM in patients with renal dysfunction are needed. Because of greater product cost and scarcity of documented benefit compared with HOCM, selection of LOCM based on the presence of renal dysfunction cannot be recommended at this time.
Beta-Adrenergic Agonists for Acute, Severe Asthma
Authors: Kelly H. William , Murphy Shirley
Published: January 2017

OBJECTIVE:

To critically review the use of beta-adrenergic agonists in acute, severe asthma with particular focus on aerosol administration.

DATA SOURCES:

English language articles published since 1971 on the use of beta-agonists for acute asthma. Studies were identified from bibliographies of book chapters, review articles, and other research articles.

STUDY SELECTION:

All studies (21 total) comparing systemic with inhaled beta-agonists were reviewed, regardless of their design or outcome. Selected studies highlighting specific aspects of beta-agonist use in acute asthma such as beta-agonists versus other bronchodilators, aerosol delivery, and intravenous beta-agonists were also reviewed.

DATA EXTRACTION:

Performed subjectively by the authors with specific aspects of quality discussed within the body of the article.

DATA SYNTHESIS:

The beta-agonists provide superior bronchodilation in acute severe asthma compared with either the methylxanthines and/or anticholinergics. The majority of studies found aerosolized beta-agonists to be either as effective as or more effective than parenteral beta-agonists and to produce fewer adverse cardiovascular effects. Studies showing preference for parenteral therapy have either been of poor design or used low doses of an aerosolized beta-agonist. Based on studies of aerosol delivery, there is no advantage of jet nebulization over metered-dose inhalers; however, other aspects, including ease of administration, favor nebulization as the delivery method of choice. The articles recommending intravenous beta-agonists consist of a series of uncontrolled cases.

CONCLUSIONS:

Aerosolized selective beta2-agonists are the bronchodilator treatments of choice for acute, severe asthma. Attention to the details of dosing and delivery are required for optimal results. The final dose and dosing interval are determined by the patient's response. Intravenous beta-agonists are hazardous and cannot be recommended.
Metered-Dose Inhalers and Nebulizers in the Acute Setting
Authors: Kisch Glenn L. , Paloucek Frank P.
Published: January 2017

OBJECTIVE:

This article evaluates the current literature comparing beta-adrenergic agonists administered via metered-dose inhalers (MDIs) with nebulizer devices in adult and pediatric patients. These studies focus on the acute treatment of asthma or chronic obstructive pulmonary disease in the emergency department and other acute care settings.

DATA SOURCES:

English-language journal articles published between 1980 and 1991.

STUDY SELECTION:

Eight studies that compared beta-adrenergic agonists administered via an MDI or an MDI with a spacing device versus a nebulizer were identified. All of the studies were either poorly designed or had few subjects. By consensus of the authors, all were included in the review.

DATA EXTRACTION:

Studies were assessed according to methodologic strength (e.g., prospective, comparative).

DATA SYNTHESIS:

Five studies found no differences between administration methods, one study found metered-dose inhalation to be superior, and another found nebulization to be superior based on observed improvements in pulmonary function tests. There were no significant differences in adverse-reaction rates. When surveyed, subjects preferred MDIs to nebulizers. There were marked variations in doses administered within and between studies. There was no consideration given to doses potentially delivered to the lungs.

CONCLUSIONS:

There is no significant difference between nebulizers and MDIs plus a spacer with regard to the administration of beta-agonists in the treatment of acute asthma. There are insufficient data to conclusively support the role of spacers in this setting. The choice of a specific delivery method at this time must be determined on an individual basis, taking into account the issues of cost, timeliness of administration, and personnel availability.
Guide to Interpreting and Evaluating the Pharmacoepidemiologic Literature
Authors: Porta Miquel S. , Tilson Hugh H. , Hartzema Abraham G.
Published: January 2017

The purpose of this guide is to provide review criteria for the pharmacoepidemiologic literature. Case-control and cohort studies are the major methodologies used in pharmacoepidemiologic analysis. Evaluation criteria for case-control and cohort studies address proper sample-frame definition, compatibility of cases and controls, drug-exposure validations, unintended-effect ascertainment procedures, and considerations for confounding. Moreover, interpretation of the statistics used in reporting cohort and case-control studies is provided. Further review criteria are given for meta-analysis, an approach to integrating the pharmacoepidemiologic literature.
Massive Theophylline Dosing in a Heavy Smoker Receiving Both Phenytoin and Phenobarbital
Authors: Nicholson James P. , Basile Sharon A. , Cury James D.
Published: January 2017

OBJECTIVE:

To report unusually high theophylline dosing requirements in a smoker receiving concomitant therapy with phenytoin and phenobarbital.

DESIGN:

Single case report.

SETTING:

517-bed, university teaching hospital.

PATIENT:

29-year-old woman with newly diagnosed asthma, heavy smoking history, and a seizure disorder.

RESULTS:

The additive influence of smoking, phenytoin, and phenobarbital greatly increased the theophylline dosing requirements. Doses of up to 4 g/d (59 mg/kg/d) were required to achieve adequate symptomatic relief of her asthma as well as to provide therapeutic serum theophylline concentrations.

CONCLUSIONS:

Multiple polymorphisms may additively influence theophylline metabolism and exceptionally large theophylline doses may be required in some patients who smoke and are comedicated with phenytoin and phenobarbital.
Cefotaxime and Metabolite Disposition in Two Pediatric Continuous Ambulatory Peritoneal Dialysis Patients
Authors: Paap Christopher M. , Nahata Milap C. , Mentser Mark A. , Mahan John D. , Puri Surendra K. , Hubbard John A.
Published: January 2017

OBJECTIVE:

To characterize the pharmacokinetics of cefotaxime and desacetylcefotaxime in pediatric patients undergoing continuous ambulatory peritoneal dialysis (CAPD) after intraperitoneal administration of cefotaxime.

DESIGN:

Case series.

SETTING:

Ambulatory children from Children's Hospital nephrology clinic, Columbus, Ohio.

PATIENT POPULATION:

Two adolescents without peritonitis.

METHODS:

A single intraperitoneal dose of cefotaxime 500 mg per 1 L dianeal was given during CAPD. Cefotaxime and desacetylcefotaxime were measured in plasma, urine, and dialysate by HPLC.

RESULTS:

Maximum plasma concentration (Cmax,) of cefotaxime was 11.94 and 13.08 mg/L and that of desacetylcefotaxime 5.73 and 5.33 mg/L. Time to reach maximum concentration (Tmax) of cefotaxime was 2.22 and 4.08 h, and that of desacetylcefotaxime was 5.33 and 5.73 h after instillation of the intraperitoneal cefotaxime dose. Systemic absorption of cefotaxime was 56.6 and 64.8 percent. Total clearance of cefotaxime was 62 and 79 mL/min/1.73 m2. Nonrenal clearance accounted for nearly 95 percent; renal and CAPD clearance contributed approximately 5 percent of the total clearance. Renal and CAPD clearance measurements of desacetylcefotaxime were similar to those for cefotaxime. Cefotaxime half-life was 1.83 and 2.49 h and desacetylcefotaxime half-life was 8.14 and 11.0 h.

CONCLUSIONS:

Cefotaxime was well absorbed and therapeutic serum concentrations were achieved after intraperitoneal administration. Renal and CAPD clearances for cefotaxime and desacetylcefotaxime were low. Cefotaxime nonrenal clearance was unaffected. Further studies are needed to establish appropriate intraperitoneal dosing guidelines of cefotaxime in pediatric CAPD patients.
Gallium Nitrate
Authors: Hughes Thomas E. , Hansen Lea Ann
Published: January 2017

OBJECTIVE:

To evaluate the therapeutic role of gallium nitrate in the treatment of hypercalcemia associated with malignancy and related disease states.

DATA SOURCES:

A literature search of English-language studies involving gallium nitrate for the period 1966–1991 using MEDLINE and the bibliographies of relevant articles.

STUDY SELECTION:

Because of the limited number of studies, all clinical trials were reviewed, with particular emphasis on Phase III comparative trials. Related investigative studies on the pharmacology, pharmacokinetics, and toxicity of gallium nitrate were also reviewed.

DATA EXTRACTION:

Two appraisers independently abstracted data from available clinical trials and evaluated trial quality.

RESULTS OF DATA SYNTHESIS:

Two Phase III comparative trials evaluating gallium nitrate in the treatment of hypercalcemia of malignancy have been completed. Gallium nitrate was shown to be superior to both calcitonin and etidronate disodium, based on the comparative percentage of patients achieving normocalcemia and the subsequent duration of normocalcemia. Both trials employed similar methodology. Positive therapeutic effects of gallium nitrate have also been demonstrated in small, noncomparative trials for hypercalcemia associated with parathyroid carcinoma, Paget's disease of bone, and osteolytic bone metastases.

CONCLUSIONS:

Gallium nitrate is effective in the treatment of hypercalcemia associated with malignancy and is appropriate for formulary addition. In certain clinical situations, it may be clearly advantageous over such agents as calcitonin, plicamycin, and etidronate. Further investigation is needed to define the limitations of nephrotoxicity and the therapeutic potential for other indications. Further comparative clinical trials of gallium nitrate versus bisphosphonates and plicamycin could also help define its relative clinical benefit.
Long-Term Use of Neuroleptics among Elderly in a Swedish Community
Authors: Stewart Ronald B. , Isacson Dag G.L. , Bingefors Kerstin A.L. , Antonov Karolina I.M.
Published: January 2017

OBJECTIVE:

Analysis of long-term use of neuroleptics among the elderly in a Swedish community.

DESIGN:

Cohort study, three-year follow-up period.

SETTING:

Primary care.

PATIENTS:

All people aged 65 years or older who used neuroleptics in 1984.

RESULTS:

Neuroleptic use was fairly common among elderly and continued long-term use was relatively frequent. One third of long-term users obtained doses exceeding a recommended dosage range. Prescribed doses were seldom changed during the study period.

CONCLUSIONS:

The high proportion of long-term users and the stability of the prescribed doses indicate that there is a need for more information to be made available to prescribers regarding the risks of long-term use of neuroleptics in primary care.
Feasibility Study of Surveying the Adverse Drug Reaction Surveillance Systems in a Large Community of Hospitals
Authors: Hartzema Abraham G. , Porta Miquel S. , Tilson Hugh H. , Herrera Carlos R. , Moss Jeffrey T. , Reves Randall R. , Buffler Patricia A.
Published: January 2017

OBJECTIVE:

To determine the feasibility of accurately assessing the types of hospital adverse drug reaction (ADR) surveillance systems.

DESIGN:

Cross-sectional survey by mailed, self-administered questionnaire followed by selected verification interviews.

SETTING:

Harris County, Texas.

PARTICIPANTS:

All hospitals in the county with different pharmacy directors.

MAIN OUTCOME MEASURE:

Self description of surveillance system and number of ADRs reported.

RESULTS:

Forty-nine of 61 hospitals (80 percent) responded to a questionnaire. Forty-seven (96 percent) of the responding hospitals collected information on ADRs with 11 (22 percent) describing their surveillance system as active. Those individuals most often cited as responsible for ADR surveillance included pharmacists, quality assurance personnel, and nurses. Data were verified by personal interviews for 10 hospitals. The number of ADRs reported during the interviews was significantly lower than that reported in the questionnaires. Overall, the reporting of fatal and severe ADRs were more reliable than the reporting of moderate ADRs. These differences were the result of inadequate documentation and the lack of a uniform definition of ADRs.

CONCLUSIONS:

These data suggest that a large-scale ongoing survey of surveillance systems and reported adverse event rates has limitations and the reliability of data derived from a questionnaire should be verified. To improve the accuracy of surveys used to monitor hospital ADR surveillance systems, it is essential to develop reliable definitions for classifying ADRs and surveillance methods, as well as accurate measures of ADR documentation procedures.
Information Systems for Evaluating the Quality of Prescribing
Authors: Fish Catherine A. , Kirking Duane M. , Martin James B. , De Almentero Daisy Rivera
Published: January 2017

OBJECTIVE:

An important purpose of drug usage evaluation (DUE) is to provide feedback to physicians on population-based prescribing patterns and problems. This article has four objectives: (1) to outline prescribing information requirements for a computerized information system in terms of the variables needed for DUE, (2) to describe existing computerized information systems that collect and organize prescribing data, (3) to assess existing systems in terms of their capacity to provide the requirements outlined in our first objective, and (4) to suggest design changes to existing systems that would improve the DUE process.

ANALYSIS:

There are several existing DUE information systems that have some capacity to evaluate the quality of prescribing in specific populations (e.g., veterans, public and private insured groups, hospital service areas). Shortcomings of most DUE information systems include patient identification problems, defects in database design, and lack of software to identify prescribing problems and perform statistical analysis.

CONCLUSIONS:

DUE information systems could be used and upgraded to enable physicians to develop more rational prescribing rules from population data that would improve the quality of prescribing.
Enalapril to Lisinopril: Economic Impact of a Voluntary Angiotensin-Converting Enzyme-Inhibitor Substitution Program in a Staff-Model Health Maintenance Organization
Authors: McGhan William F. , Bootman J. Lyle , Townsend Raymond J. , McDonough Kimberly P. , Weaver Ross H. , Viall Gary D.
Published: January 2017

OBJECTIVE:

The cost-effectiveness of a voluntary program that switched enalapril to lisinopril therapy in patients with benign essential hypertension in a staff-model health maintenance organization (HMO) was evaluated.

DESIGN:

The one-year nonrandomized, controlled trial was performed from November 1989 through October 1990.

PARTICIPANTS:

One hundred twenty-seven patients were entered into the study: 75 who converted from enalapril to lisinopril and 52 who remained on enalapril throughout the study period. Patients were excluded from analysis because of diagnosis (not benign essential hypertension) or insufficient data collection.

INTERVENTIONS:

Patients taking enalapril were asked by staff pharmacists if they were willing to consider switching from enalapril to lisinopril. To encourage patients, the HMO agreed to waive the drug rider copayment for three months. If patients were willing, their physicians were contacted and they established the lisinopril dosage.

MAIN OUTCOME MEASURES:

Total direct cost and savings resulting from converting patients from enalapril to lisinopril were measured and compared with costs of therapy for patients who remained on enalapril.

RESULTS:

The control and study groups were evenly matched according to demographics and concomitant drug therapy. Drug acquisition costs, costs associated with waiving drug rider copayment, pharmacy administrative costs, costs of managing adverse events, costs of visits to physicians, and laboratory test costs were assessed. Depending on the cost of capital assumed, net savings ranged from $85 to $110 per patient converted from enalapril to lisinopril. Monthly net savings that ranged from $2.04 to $2.61 per patient were required to result in overall net savings within the first two years.

CONCLUSIONS:

In a regular practice setting, a net savings is realized in less than 12 months when patients are converted from enalapril to lisinopril for treatment of benign essential hypertension. The voluntary therapeutic interchange program provided a good means for achieving cost controls for pharmacy expenses.
European Survey of Independent Drug Information Centers
Authors: Taggiasco Nadine , Sarrut Bernard , Doreau Christian G.
Published: January 2017

OBJECTIVE:

The purpose of our survey was to ascertain the activities of the independent drug information centers (DICs) in Europe and to contact the person in charge of these services to establish a European network of DICs in the future.

DATA SOURCES:

The survey was conducted in 32 European countries. We contacted 2026 people in DICs and official healthcare organizations by mail. On request, we returned our questionnaire including 167 closed questions on the means and activities of a DIC. Data were collected and analyzed on a personal computer using dBASE III PLUS (Ashton-Tate).

RESULTS:

Of the 110 questionnaires received, 88 answered the question pertaining to the number of queries asked of the DIC per year and were analyzed (1 from West Germany, Denmark, Finland, Sweden, Portugal, Poland; 2 from Italy; 3 from Switzerland; 6 from Spain; 8 from The Netherlands; 16 from France; and 47 from the United Kingdom). We recorded data on their location, their means (e.g., staff, information), their users (e.g., health professionals), and activities.

CONCLUSIONS:

The DICs were located in healthcare structures, managed by pharmacists or physicians, and open to other health professionals. Only the United Kingdom maintains a national organized network. Most of the participants showed interest in cooperating with each other to establish a list of the centers, guidelines on good information practices, a database, and a European network.
Result of Arthrodesis of the Hallux Metatarsophalangeal Joint Using Bone Graft for Restoration of Length
Authors: Myerson Mark S. , Schon Lew C. , McGuigan Francis X. , Oznur Ali
Published: January 2017

We treated 24 patients (18 women, six men; average age, 46.4 years; (range, 28 to 66 years) with fusion of the hallux metatarsophalangeal (MTP) joint using bone graft for the restoration of the length of the first ray. This procedure was performed after bone loss subsequent to previous surgeries for the correction of hallux valgus and hallux rigidus with: silastic arthroplasty (11), bunionectomy and distal metatarsal osteotomy (six), Keller resection arthroplasty (five), and total joint replacement (two). The indication for performing the arthrodesis with bone graft was a short first metatarsal, and associated metatarsalgia of the lesser metatarsals in addition to a painful MTP joint with or without deformity. This bone loss was associated with avascular necrosis of the first metatarsal (nine patients) and with osteomyelitis (seven patients). Of the 24 patients, 14 underwent additional concurrent surgery for correction of hammer toes (10), excision of a Morton's neuroma (two), and lesser metatarsal osteotomy (two). All patients were examined clinically and radiographically at a mean interval of 62.7 months after surgery (range, 26 to 108 months). The patients were evaluated using the American Orthopaedic Foot and Ankle Society (AOFAS) hallux and MTP 100-point outcome scale. Arthrodesis occurred in 19/24 patients (79.1%) at a mean of 13.3 weeks (range, 11 to 16 weeks), and the first ray was lengthened by a mean of 13 mm (range, 0 to 29 mm). Of the five nonunions, two were asymptomatic, and three were subsequently revised successfully, with arthrodesis occurring at a mean of 10.7 weeks. Complications included one deep infection requiring intravenous antibiotics for treatment of osteomyelitis and two minor superficial wound infections. The mean AOFAS score improved from 39 points (range, 22 to 60 points) to 79 points (range, 64 to 90 points). All patients were satisfied with the final outcome of treatment and stated that they would undergo the surgical procedure again. We concluded that arthrodesis of the hallux MTP joint with bone graft to restore bone loss and length of the first ray may be a worthwhile procedure despite the technical difficulty and the high rate of nonunion.
A Technique for Isolated Arthrodesis for Inflammatory Arthritis of the Talonavicular Joint
Authors: Chiodo Christopher P. , Martin Tammy , Wilson Michael G.
Published: January 2017

There are few reports in the literature documenting the efficacy of isolated arthrodesis for inflammatory arthritis of the talonavicular joint. Accordingly, we reviewed a single surgeon's experience with this procedure in twenty consecutive cases from this patient population. A technique using indirect joint distraction and the combined use of screw and staple fixation was employed. Solid arthrodesis was noted radiographically in 19 of 20 feet (95%) at an average of 11 weeks. Complications included one non-union, one deep venous thrombosis, and one superficial wound infection. Objective results were graded as excellent in 16 cases, good in 3 cases, and poor in one case. Subjectively, 18 patients were satisfied and one patient dissatisfied with the results of the procedure. It is concluded that isolated arthrodesis is an effective procedure for the treatment of inflammatory arthritis of the talonavicular joint, offering significant pain relief and improved function. Additionally, the use of indirect joint distraction and fixation with screws and staples is a reliable technique associated with an excellent fusion rate.