Medicine and Health Sciences Commons^™

The Role Of Surveillance Duplex Scanning In Preventing Venous Thromboembolism In Trauma Patients., Mark D. Cipolle, Randolph Wojcik Md, Elizabeth Seislove, Thomas E. Wasser, Michael D. Pasquale Md, Facs, Fccm

Michael D Pasquale MD, FACS, FCCM

BACKGROUND: This study was performed to determine the role of duplex scanning in preventing pulmonary embolism (PE), the correlation of venous thromboembolism (VTE) risk score with the incidence of deep venous thrombosis (DVT), and patients who may benefit from surveillance duplex scanning.

METHODS: Age, sex, Injury Severity Score (ISS), VTE score, length of stay, diagnoses, and bleeding risk were recorded from the trauma registry in patients who had a duplex scan from 1995 to 2000.

RESULTS: There were 1,513 duplex scans obtained (10,141 trauma admissions), 253 (2.5%) cases of DVT (52% above-knee, 8% upper extremity), and 30 cases of PE …

Is Extended Volume External Beam Radiation Therapy Covering The Anastomotic Site Beneficial In Post-Esophagectomy High Risk Patients?, Edward Yu, Rashid Dar, George Rodrigues, Larry Stitt, Gregory Videtic, Pauline Truong, Anna Tomiak, Robert Ash, Ed Brecevic, Richard Inculet, Richard Malthaner, Mark Vincent, Ian Craig, Walter Kocha, Michael Lefcoe

Richard A. Malthaner

Background and purpose: To assess the impact of extended volume radiation therapy (RT) with anastomotic coverage on local control in high risk post-operative esophageal cancer patients.

Patients and methods: This is a retrospective study of high risk (T(3), T(4), nodes positive, with or without margin involvement) post-operative esophageal cancer patients treated at London Regional Cancer Centre from 1989 to 1999. After esophagectomy, all patients received adjuvant combined modality therapy consisting of four cycles of fluorouracil-based chemotherapy, and loco-regional RT with or without coverage of the anastomotic site. RT dose ranged from 45 to 60 Gy at 1.8-2.0 Gy/fraction with treatment …

Is Extended Volume External Beam Radiation Therapy Covering The Anastomotic Site Beneficial In Post-Esophagectomy High Risk Patients?, Edward Yu, Rashid Dar, George Rodrigues, Larry Stitt, Gregory Videtic, Pauline Truong, Anna Tomiak, Robert Ash, Ed Brecevic, Richard Inculet, Richard Malthaner, Mark Vincent, Ian Craig, Walter Kocha, Michael Lefcoe

Richard A. Malthaner

Background and purpose: To assess the impact of extended volume radiation therapy (RT) with anastomotic coverage on local control in high risk post-operative esophageal cancer patients.

Patients and methods: This is a retrospective study of high risk (T(3), T(4), nodes positive, with or without margin involvement) post-operative esophageal cancer patients treated at London Regional Cancer Centre from 1989 to 1999. After esophagectomy, all patients received adjuvant combined modality therapy consisting of four cycles of fluorouracil-based chemotherapy, and loco-regional RT with or without coverage of the anastomotic site. RT dose ranged from 45 to 60 Gy at 1.8-2.0 Gy/fraction with treatment …

A Case Report Of A Simultaneous Local Osteochondral Autografting And Ankle Arthrodiastasis For The Treatment Of A Talar Dome Defect., Ronald Belczyk, John Stapleton, Thomas Zgonis, Vasilios D Polyzois

John J Stapleton DPM, FACFAS

Talar osteochondral defects (OCDs) are a challenge for treating physicians because they frequently are missed or diagnosed incorrectly, often resulting in severe degenerative arthritis of the ankle joint. Surgical intervention becomes a viable option in the presence of larger OCDs associated with loose bodies or osteochondral lesions that have failed conservative treatment. The successful use of autologous osteochondral autograft in the knee has promoted the applicability in the ankle. This report describes a unique technique for the treatment of large talar osteochondral lesions using a local osteochondral autograft combined with an ankle arthrodiastasis.

Combined Lateral Column Arthrodesis, Medial Plantar Arteryflap, And Circular External Fixation For Charcot Midfoot Collapse With Chronic Plantar Ulceration., Thomas Zgonis, Thomas S Roukis, John Stapleton, Douglas T Cromack

John J Stapleton DPM, FACFAS

No abstract provided.

Combined Medial Displacement Calcaneal Osteotomy, Subtalar Joint Arthrodesis, And Ankle Arthrodiastasis For End-Stage Posterior Tibial Tendon Dysfunction., John Stapleton, Ronald Belczyk, Thomas Zgonis, Vasilios D Polyzois

John J Stapleton DPM, FACFAS

Combining an ankle arthrodiastasis with a medial displacement calcaneal osteotomy and a subtalar joint arthrodesis offers surgeons a joint-sparing procedure for young and active patients who have end-stage posterior tibial tendon dysfunction and ankle joint involvement. An isolated subtalar joint arthrodesis or triple arthrodesis combined with an ankle arthrodiastasis is an option that can be used in certain case scenarios. Delaying the need for a joint destructive procedure through an ankle arthrodiastasis, however, may have a great impact in the near future, as advancements are underway to improve the use of ankle endoprosthesis.

Role Of Multiple Births In Very Low Birth Weight And Infant Mortality, B. Magee

B. Dale Magee

OBJECTIVE: To determine the percentage of very-low-birth-weight (VLBW) infants (g) and infant deaths attributable to multiple births in the general population and in women aged 35+. STUDY DESIGN: The year 2000 Massachusetts birth certificate database with linked births-deaths was examined. Etiologic fractions (EF) for VLBW and infant mortality attributable to multiples were calculated for the general population and the 35+ age group. The percentages of multiples occurring in the 35+ age group were calculated. Infant deaths due to congenital anomalies and "perinatal conditions" were calculated. RESULTS: There were 81,582 resident births in Massachusetts in 2000. Of them 4.3% were multiples. …

A Randomized, Double-Blind, Placebo-Controlled Study To Assess The Effect Of Recombinant Human Erythropoietin On Functional Outcomes In Anemic, Critically Ill, Trauma Subjects: The Long Term Trauma Outcomes Study, Fred Luchette, Michael Pasquale, Timothy Fabian, Wayne Langholff, Marsha Wolfson

Michael D Pasquale MD, FACS, FCCM

BACKGROUND: Achieving a higher hemoglobin (Hb) level might allow the anemic, critically ill, trauma patient to have an improved outcome during rehabilitation therapy. METHODS: Patients with major blunt trauma orthopedic injuries were administered epoetin alfa or placebo weekly both in hospital and for up to 12 weeks after discharge or until the Hb level was >12.0 g/dL, whichever occurred first. The 36-question Short Form Health Assessment questionnaire (SF-36) was used to evaluate physical function (PF) outcomes at baseline, at hospital discharge, and at several time points posthospital discharge. RESULTS: One hundred ninety-two patients were enrolled (epoetin alfa [n = 97], …

Prediction Of Radiation Pneumonitis By Dose-Volume Histogram Parameters In Lung Cancer--A Systematic Review, George Rodrigues, Michael Lock, David D'Souza, Edward Yu, Jake Van Dyk

Michael Lock

BACKGROUND AND PURPOSE: To perform a systematic review of the predictive ability of various dose-volume histogram (DVH) parameters (V(dose), mean lung dose (MLD), and normal tissue complication probability (NTCP)) in the incidence of radiation pneumonitis (RP) caused by external-beam radiation therapy.

METHODS AND MATERIALS: Studies assessing the relationship between CT-based DVH reduction parameters and RP rate in radically treated lung cancer were eligible for the review. Synonyms for RP, lung cancer, DVH and its associated parameters (NTCP, V(20), V(30), MLD) were combined in a search strategy involving electronic databases, secondary reference searching, and consultation with experts. Individual or group data …

Milwaukee Police Department Retirees: Cardiovascular Disease Risk And Morbidity Among Aging Law Enforcement Officers, Sandra Ramey, Nancy Downing, W. Franke

Nancy R Downing

This study explored the self-reported prevalence of cardiovascular disease (CVD) and accompanying risk factors among 165 male retirees 43 years and older (M = 56.2, SD = 7.1) from the Milwaukee Police Department (MPD) compared to 671 individuals of similar age and income who responded to the 2005 Wisconsin Behavioral Risk Factor Surveillance System (BRFSS). CVD and other risk factors were more prevalent in the MPD retirees than the general population (CVD 15.2% vs. 9.5%, p = .036; hypertension 51.5% vs. 36.2%, p = .001; hypercholesterolemia 62.4% vs. 44.4%, p = .001; overweight and obesity 85.1% vs. 74.7%, p = …

Tubercular Pancreatic Abscess Presenting As Fever And Cystic Pancreatic Lesion With Endoscopic Management., Jonathan Fenkel, Maya Spodik, Bheema Singu, Anthony Infantolino, Sandeep Deshmukh, David Loren

Sandeep Deshmukh

Isolated pancreatic tuberculosis is a rare presentation of tubercular infection. There are few reported cases of pancreatic tuberculosis diagnosed by endoscopic ultrasound with fine-needle aspiration (EUS FNA), though EUS is often used in the evaluation of pancreatic cystic lesions. We present a case of a tubercular pancreatic abscess presenting as a cystic lesion in a patient with undiagnosed immunodeficiency. The abscess was aspirated by EUS FNA and treated with endoscopic drainage and anti-mycobacterial medications.

Concordance Between Self-Reported Maltreatment And Court Records Of Abuse Or Neglect Among High-Risk Youths, Monica Swahn, Daniel Whitaker, Courtney Pippen, Rebecca Leeb, Linda Teplin, Karen Abram, Gary Mcclelland

Monica H. Swahn

Objectives: We examined the concordance between measures of self-reported maltreatment and court records of abuse or neglect in a sample of detained youths.

Methods: Data were collected by the Northwestern Juvenile Project and include interviews from 1829 youths aged 10–18 years. Participants were newly detained youths in the Cook County Juvenile Temporary Detention Center in Illinois between 1995 and 1998. Self-reported cases of child maltreatment were compared with court records of abuse or neglect in the Cook County judicial system.

Results: We found that among detained youths, 16.6% of those who reported any maltreatment, 22.2% of those who reported the …

Perceived Accessibility As A Predictor Of Youth Smoking, Chyke Doubeni, Wenjun Li, Hassan Fouayzi, Joseph Difranza

Chyke A. Doubeni

PURPOSE: Youths who smoke are more likely to perceive that cigarettes are easily accessible, but the relationship between perceived accessibility of cigarettes and the risk of smoking is not clear. The objective of this study was to determine whether perceived accessibility predicted future smoking among youths. METHODS: This study used data from the second Development and Assessment of Nicotine Dependence in Youth (DANDY-2) study, a 4-year (2002-2006) cohort study that began with 1,246 sixth-grade students in 6 Massachusetts communities. DANDY-2 comprised 11 waves of in-person interviews. A total of 1,195 students who were aged 11 to 14 years at the …

Does Clinical Equipoise Apply To Cluster Randomized Trials In Health Research?, Ariella Binik, Charles Weijer, Andrew Mcrae, Jeremy Grimshaw, Robert Boruch, Jamie Brehaut, Allan Donner, Martin Eccles, Raphael Saginur, Monica Taljaard, Merrick Zwarenstein

Charles Weijer

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, Weijer and colleagues set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the third of the questions posed, namely, does clinical equipoise apply to CRTs in health research? The ethical principle of beneficence is the moral obligation not to harm needlessly and, when possible, to promote the welfare of research subjects. Two related ethical problems have …

Ethical Issues Posed By Cluster Randomized Trials In Health Research, Charles Weijer, Jeremy Grimshaw, Monica Taljaard, Ariella Binik, Robert Boruch, Jamie Brehaut, Allan Donner, Martin Eccles, Antonio Gallo, Andrew Mcrae, Raphael Saginur, Merrick Zwarenstein

Charles Weijer

The cluster randomized trial (CRT) is used increasingly in knowledge translation research, quality improvement research, community based intervention studies, public health research, and research in developing countries. However, cluster trials raise difficult ethical issues that challenge researchers, research ethics committees, regulators, and sponsors as they seek to fulfill responsibly their respective roles. Our project will provide a systematic analysis of the ethics of cluster trials. Here we have outlined a series of six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation: 1. Who is a research subject? 2. …

Body Mass Index, Treatment Practices, And Mortality In Patients With Acute Heart Failure, Timothy Fitzgibbons, Olga Hardy, Darleen Lessard, Joel Gore, Jorge Yarzebski, Robert Goldberg

Jorge L. Yarzebski

OBJECTIVES: Obesity is associated with an increased risk of heart failure (HF). Among patients presenting with acute HF, however, differences in clinical characteristics, treatment regimens, and short-term prognosis of varying weights are largely unknown, particularly from a broader population-based perspective. METHODS: A total of 3722 patients admitted with acute HF to 11 greater Worcester (Massachusetts, USA) hospitals during 1995 and 2000 were categorized as being lean (n = 216), normal weight (n = 1465), overweight (n = 1007), or obese (n = 1034) at the time of hospitalization. RESULTS: Obese patients with decompensated HF were significantly younger (mean age = …

Ethical And Policy Issues In Cluster Randomized Trials: Rationale And Design Of A Mixed Methods Research Study, Monica Taljaard, Charles Weijer, Jeremy Grimshaw, Judith Brown, Ariella Binik, Robert Boruch, Jamie Brehaut, Shazia Chaudhry, Martin Eccles, Andrew Mcrae, Raphael Saginur, Merrick Zwarenstein, Allan Donner

Charles Weijer

Background: Cluster randomized trials are an increasingly important methodological tool in health research. In cluster randomized trials, intact social units or groups of individuals, such as medical practices, schools, or entire communities--rather than individual themselves--are randomly allocated to intervention or control conditions, while outcomes are then observed on individual cluster members. The substantial methodological differences between cluster randomized trials and conventional randomized trials pose serious challenges to the current conceptual framework for research ethics. The ethical implications of randomizing groups rather than individuals are not addressed in current research ethics guidelines, nor have they even been thoroughly explored. The main …

Minimal Risk And Large-Scale Biobank And Cohort Research, Timothy Caulfield, Charles Weijer

Charles Weijer

No abstract provided.

Ethical Issues Associated With The Introduction Of New Surgical Devices, Or Just Because We Can, Doesn’T Mean We Should, Sue Ross, Magali Robert, Marie-Andrée Harvey, Scott Farrell, Jane Schulz, David Wilkie, Danny Lovatsis, Annette Epp, Bill Easton, Barry Mcmillan, Joyce Schachter, Chander Gupta, Charles Weijer

Charles Weijer

Surgical devices are often marketed before there is good evidence of their safety and effectiveness. Our paper discusses the ethical issues associated with the early marketing and use of new surgical devices from the perspectives of the six groups most concerned. Health Canada, which is responsible for licensing new surgical devices, should amend their requirements to include rigorous clinical trials that provide data on effectiveness and safety for each new product before it is marketed. Industry should comply with all Health Canada requirements to obtain licenses for new products. Until Health Canada requires effectiveness and safety data, industry should cooperate …

Ethics Of Surgical Training In Developing Countries, Kevin Ramsey, Charles Weijer

Charles Weijer

The practice of surgical trainees operating in developing countries is gaining interest in the medical community. Although there has been little analysis about the ethical impact of these electives, there has been some concerns raised over the possible exploitation of trainees and their patients. An ethical review of this practice shows that care needs to be taken to prevent harm. Inexperienced surgeons learning surgical skills in developing countries engender greater risk of violating basic ethical principles. Advanced surgical trainees who have already achieved surgical competence are best qualified to satisfy these ethical issues. All training programs need to develop a …

Evaluating Benefits And Harms In Intensive Care Research, Charles Weijer, Paul Miller

Charles Weijer

No abstract provided.

Refuting The Net Risks Test: A Response To Wendler And Miller's "Assessing Research Risks Systematically", Charles Weijer, Paul Miller

Charles Weijer

Earlier in the pages of this journal (p 481), Wendler and Miller offered the "net risks test" as an alternative approach to the ethical analysis of benefits and harms in research. They have been vocal critics of the dominant view of benefit-harm analysis in research ethics, which encompasses core concepts of duty of care, clinical equipoise and component analysis. They had been challenged to come up with a viable alternative to component analysis which meets five criteria. The alternative must (1) protect research subjects; (2) allow clinical research to proceed; (3) explain how physicians may offer trial enrolment to their …

Nodal Ratios In Node-Positive Breast Cancer—Long-Term Study To Clarify Discrepancy Of Role Of Supraclavicular And Axillary Regional Radiotherapy, Patricia Tai, Kurian Joseph, Evgeny Sadikov, Shazia Mahmood, Francis Lien, Edward Yu

Edward Yu

Purpose: To study the absolute number of involved nodes/the number of nodes examined or the nodal ratio (NR) in breast cancer. The primary study endpoint was to evaluate the role of supraclavicular and axillary radiotherapy (SART) according to the NR. Methods and materials: From the Saskatchewan provincial registry of 1981-1995, the charts of 5,996 consecutive patients were retrieved to collect detailed prognostic factors. Among these patients, 1,985 were node positive. Because the NRs are more reliable the greater the number of nodes examined, we analyzed 1,255 patients with > or =10 nodes examined. Of these 1,255 patients, 667, 389, and 199 …

Evaluating Benefits And Harms In Clinical Research, Paul Miller, Charles Weijer

Charles Weijer

No abstract provided.

Risk In Emergency Research Using A Waiver Of/Exception From Consent: Implications Of A Structured Approach For Institutional Review Board Review, Andrew Mcrae, Stacy Ackroyd-Stolarz, Charles Weijer

Charles Weijer

OBJECTIVE: To apply component analysis, a structured approach to the ethical analysis of risks and potential benefits in research, to published emergency research using a waiver of/exception from informed consent. The hypothesis was that component analysis could be used with a high degree of interrater reliability, and that the vast majority of emergency research would comply with a minimal-risk threshold.

METHODS: A Medline search and manual search were done to identify studies using a waiver of/exception from informed consent published between July 1996 and December 2000. A review panel of physicians and bioethicists independently classified nontherapeutic procedures in each study …

Evaluating Risks Of Non-Therapeutic Research In Children, Paul Miller, Charles Weijer

Charles Weijer

No abstract provided.

Is Extended Volume External Beam Radiation Therapy Covering The Anastomotic Site Beneficial In Post-Esophagectomy High Risk Patients?, Edward Yu, Rashid Dar, George Rodrigues, Larry Stitt, Gregory Videtic, Pauline Truong, Anna Tomiak, Robert Ash, Ed Brecevic, Richard Inculet, Richard Malthaner, Mark Vincent, Ian Craig, Walter Kocha, Michael Lefcoe

Edward Yu

Background and purpose: To assess the impact of extended volume radiation therapy (RT) with anastomotic coverage on local control in high risk post-operative esophageal cancer patients. Patients and methods: This is a retrospective study of high risk (T(3), T(4), nodes positive, with or without margin involvement) post-operative esophageal cancer patients treated at London Regional Cancer Centre from 1989 to 1999. After esophagectomy, all patients received adjuvant combined modality therapy consisting of four cycles of fluorouracil-based chemotherapy, and loco-regional RT with or without coverage of the anastomotic site. RT dose ranged from 45 to 60 Gy at 1.8-2.0 Gy/fraction with treatment …

When Are Research Risks Reasonable In Relation To Anticipated Benefits?, Charles Weijer, Paul Miller

Charles Weijer

The question "When are research risks reasonable in relation to anticipated benefits?" is at the heart of disputes in the ethics of clinical research. Institutional review boards are often criticized for inconsistent decision-making, a problem that is compounded by a number of contemporary controversies, including the ethics of research involving placebo controls, developing countries, incapable adults and emergency rooms. If this pressing ethical question is to be addressed in a principled way, then a systematic approach to the ethics of risk in research is required. Component analysis provides such a systematic approach.

Prediction Of Radiation Pneumonitis By Dose-Volume Histogram Parameters In Lung Cancer--A Systematic Review, George Rodrigues, Michael Lock, David D'Souza, Edward Yu, Jake Van Dyk

Edward Yu

BACKGROUND AND PURPOSE: To perform a systematic review of the predictive ability of various dose-volume histogram (DVH) parameters (V(dose), mean lung dose (MLD), and normal tissue complication probability (NTCP)) in the incidence of radiation pneumonitis (RP) caused by external-beam radiation therapy. METHODS AND MATERIALS: Studies assessing the relationship between CT-based DVH reduction parameters and RP rate in radically treated lung cancer were eligible for the review. Synonyms for RP, lung cancer, DVH and its associated parameters (NTCP, V(20), V(30), MLD) were combined in a search strategy involving electronic databases, secondary reference searching, and consultation with experts. Individual or group data …

Radiation Treatment Of Lung Cancer--Patterns Of Practice In Canada, Patricia Tai, Edward Yu, Jerry Battista, Jake Van Dyk

Edward Yu

BACKGROUND AND PURPOSE: To assess the patterns of practice among Canadian radiation oncologists who treat lung cancers. PATIENTS AND METHODS: A questionnaire detailing different aspects of radiation treatment of lung cancer was mailed to all radiation oncologists treating lung cancer in Canada. Seventy-two percent (74/103) of radiation oncologists who treat lung cancer from all 34 Canadian cancer centres replied to the questionnaire. RESULTS: (a) Radiotherapy regimens in Canadian cancer centres are in accordance with several major randomised studies. There is still some variation in treatment practice that may be due to unresolved controversies or limited resources. The most frequently used …