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PubMed2006

Guiding Principles for Pharmaceutical Physicians from the Ethical Issues Committee of the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the UK.

Medical practitioners practising in the field of pharmaceutical medicine, whether in industry, regulatory bodies or an academic environment, are bound by the same ethical standards which apply to all doctors. Their work, however, leads to some very specific ethical considerations which may not be fully explored in ethical codes based in clinical medicine. This document aims to establish some guiding principles which should underpin a working ethical framework for pharmaceutical physicians. It clearly places the protection of patients (and research subjects) and the doctor's duties to wider society ahead of responsibilities to an individual employer while emphasising the importance of adherence to high standards of research, including dissemination of findings. These principles form the basis of a fuller report which offers more specific practical advice on possible ethical conflicts or dilemmas.

Clinical Trials as Topic↗

PubMed1984

Sexually transmitted diseases: an epidemic in adolescent girls?

The prevalence of sexually transmitted disease (STD) in adolescent girls aged 15-19 attending a department of genitourinary medicine was compared for the years 1972 and 1982. Data were obtained from the confidential register using the coding of the clinic returns to the Department of Health (form SBH 60). There were 1373 patients in 1972 and 1799 in 1982, 6.4% and 7% respectively of the total female clinic population. The prevalence of syphilis, gonorrhoea, and infection with Trichomonas vaginalis, herpes simplex virus, and warts was almost unchanged. Other conditions, which are not classified as STD, were largely responsible for the increase in new attendances, the prevalence of these conditions having nearly doubled over the ten year period. Thus an epidemic of STD has not been shown in this adolescent female population over the past decade.

Adolescent↗

PubMed2004

Population-based study of symptomatic internal carotid artery occlusion: incidence and long-term follow-up.

BACKGROUND AND PURPOSE: Internal carotid artery (ICA) occlusion is an important cause of transient ischemic attack (TIA) and cerebral infarction. There are no previous population-based natural history studies evaluating outcome after symptomatic ICA occlusion (SICAO). METHODS: We performed a retrospective, population-based study of SICAO. All Olmsted County (Minnesota) residents with possible SICAO from 1986 to 2000 were identified by cross-referencing appropriate clinical and imaging codes. Inclusion criteria were cerebral infarction or TIA in a carotid distribution and imaging documentation of ipsilateral ICA occlusion <3 months after the index event. Kaplan-Meier estimates were used to calculate the risk of cerebral infarction, myocardial infarction, and death after SICAO. RESULTS: Seventy-five patients qualified. Annual SICAO incidence was 6 per 100,000 persons (age and gender adjusted to the 2000 US white population). Risk of cerebral infarction during follow-up was 8% at 30 days, 10% at 1 year, and 14% at 5 years. Five of 11 cerebral infarctions occurred within the first week after diagnosis of occlusion. Risk of myocardial infarction was 0% at 30 days, 8% at 1 year, and 24% at 5 years. Risk of death was 7%, 13%, and 29%, respectively. CONCLUSIONS: There may be 15,000 to 20,000 incident cases of SICAO in the United States annually. Risk of cerebral infarction after SICAO is initially high and then stabilizes, whereas risk of myocardial infarction is initially low but gradually increases. Better strategies are needed to reduce early stroke recurrence in this setting.

Adult↗

PubMed1997

Characterization of the AD7C-NTP cDNA expression in Alzheimer's disease and measurement of a 41-kD protein in cerebrospinal fluid.

We have isolated a novel Alu sequence-containing cDNA, designated AD7c-NTP, that is expressed in neurons, and overexpressed in brains with Alzheimer's disease (AD). The 1,442-nucleotide AD7c-NTP cDNA encodes an approximately 41-kD protein. Expression of AD7c-NTP was confirmed by nucleic acid sequencing of reverse transcriptase PCR products isolated from brain. AD7c-NTP cDNA probes hybridized with 1. 4 kB mRNA transcripts by Northern blot analysis, and monoclonal antibodies generated with the recombinant protein were immunoreactive with approximately 41-45-kD and approximately 18-21-kD molecules by Western blot analysis. In situ hybridization and immunostaining studies localized AD7c-NTP gene expression in neurons. Using a quantitative enzyme-linked sandwich immunoassay (Ghanbari, K., I. Beheshti, and H. Ghanbari, manuscript submitted for publication) constructed with antibodies to the recombinant protein, AD7c-NTP levels were measured under code in 323 clinical and postmortem cerebrospinal fluid (CSF) samples from AD, age-matched control, Parkinson's disease, and neurological disease control patients. The molecular mass of the AD7c-NTP detected in CSF was approximately 41 kD. In postmortem CSF, the mean concentration of AD7c-NTP in cases of definite AD (9.2+/-8.2 ng/ml) was higher than in the aged control group (1.6+/-0.9; P < 0.0001). In CSF samples from individuals with early possible or probable AD, the mean concentration of AD7c-NTP (4.6+/-3.4) was also elevated relative to the levels in CSF from age-matched (1.2+/-0.7) and neurological disease (1.0+/-0.9) controls, and ambulatory patients with Parkinson's disease (1.8+/-1.1) (all P < 0.001). CSF levels of AD7c-NTP were correlated with Blessed dementia scale scores (r = 0. 66; P = 0.0001) rather than age (r = -0.06; P > 0.1). In vitro studies demonstrated that overexpression of AD7c-NTP in transfected neuronal cells promotes neuritic sprouting and cell death, the two principal neuroanatomical lesions correlated with dementia in AD. The results suggest that abnormal AD7c-NTP expression is associated with AD neurodegeneration, and during the early stages of disease, CSF levels correlate with the severity of dementia.

Aged↗

PubMedDate not supplied

The changing epidemiology of mechanical ventilation: a population-based study.

The number of critical care beds in the United States has been increasing considerably, but it is unclear how these additional beds have been used. Mechanical ventilation for acute respiratory failure almost always demands ICU care and is likely to be a reliable indicator of critical care resource requirements on a population level. The objective of this study was to measure changes in the yearly incidence of mechanical ventilation in a statewide population. The North Carolina Hospital Discharge Database contains data on all discharges from nonfederal, nonpsychiatric hospitals in North Carolina. Authors extracted data on adult patients with International Classification of Diseases, 9th Revision, Clinical Modification procedure codes for mechanical ventilation from 1996 to 2002. The incidence of mechanical ventilation for adults grew from 284/100,000 population in 1996 to 314/100,000 in 2002, an increase of 11% (P < .05). While patients aged >64 had the highest age-specific incidence of mechanical ventilation each year, the greatest increase in incidence occurred in younger age groups (19% increase for age 18-64 vs 4% increase for age >64). The mean Charlson score increased from 1.76 +/- 1.73 to 1.89 +/- 1.86 (P < .001). Renal disease became more prevalent among patients requiring mechanical ventilation (17% of patients in 1996 vs 24% in 2002). Hospital charges adjusted for the medical consumer price index increased by 12%. The proportion of patients discharged to home declined from 45.4% to 34.4%, and discharges to nursing homes grew from 7.3% to 10.7%. The incidence of mechanical ventilation is increasing, and the increase is associated with a higher burden of comorbidities and fewer discharges to home.

Acute Disease↗

PubMed2003

Upper extremity deep venous thrombosis.

PURPOSE: To determine the prevalence of symptomatic upper extremity deep venous thrombosis (DVT) and its association with symptomatic acute pulmonary embolism (PE) in a community teaching hospital. METHODS: The prevalence of symptomatic upper extremity DVT was evaluated retrospectively at a community teaching hospital during the 2-year period between July 1, 1998, and June 30, 2000. Patients were identified by International Classification of Disease, ninth revision, clinical modification, discharge codes and a review of the records of all compression Doppler ultrasonograms, venograms of the upper extremities, and magnetic resonance angiograms of the upper extremities. RESULTS: Symptomatic upper extremity DVT was diagnosed in 65 of 44,136 patients of all ages (0.15%) [or 64 of 34,567 adult patients >or= 20 years of age; 0.19%]. In seven patients, the upper extremity DVT was shown by venography to extend proximally to the brachiocephalic vein. Among these, the DVT extended to the superior vena cava in two. All of the patients received anticoagulant therapy for upper extremity DVT. No patients developed symptomatic PE. Central lines at the site of the upper extremity DVT were inserted in 39 of 65 patients (60%). Cancer was diagnosed in 30 of 65 patients (46%), 23 cancer patients also had central lines, and 19 patients (29%) had upper extremity DVT with no apparent cause. All patients had swelling of the upper extremities. Erythema over the affected site was present in four patients (6%). Pain was present in 26 patients (40%), although some discomfort due to swelling was present in all patients. CONCLUSION: Symptomatic upper extremity DVT is not uncommon in hospitalized patients. Symptomatic PE resulting from upper extremity DVT was not observed in these patients, all of whom were treated with anticoagulants.

Acute Disease↗

PubMed2006

Trends in lung surgery: United States 1988 to 2002.

BACKGROUND: Reports on the temporal evolution in lung resection are limited. To elucidate temporal changes in the demographics of lung resections, we analyzed nationally representative data that were collected for the National Hospital Discharge Survey from 1988 to 2002. METHODS: Data collected between 1988 and 2002 were analyzed. Patients with International Classification of Diseases, ninth revision, clinical modification, procedure codes for lung resection were included in the sample. Three 5-year time periods were created (1988 to 1992, 1993 to 1997, and 1998 to 2002) to simplify the temporal analysis. Changes in the prevalence of procedures, age, gender, race, length of care, mortality, disposition status, and distribution by hospital size were evaluated. Trends in procedure-related complications were analyzed. RESULTS: Between 1988 and 2002, a total of 512,758 lung resections were performed. Comparing the earliest to the most recent time period, we found increases in the average age (61.1 years [range, 1 to 89 years] vs 63.2 years [range, 1 to 91 years], respectively), in the proportion of patients who were female (40.1% vs 49.6%, respectively), and in the proportion of Medicare/Medicaid patients (43.8% vs 49%/4.7% vs 6.7%, respectively). Decreases in the average length of stay (12.9 days [range, 1 to 358 days] vs 9.1 days [range, 1 to 175 days], respectively) and in the proportion of patients discharged to their primary residence (86% vs 79.5%, respectively) were seen. The proportion of patients who had undergone lobectomies compared to other types of lung resection increased. Mortality rates were 5% vs 5.4%, respectively, while the frequency of complications decreased. CONCLUSION: We identified temporal changes in lung resection surgery that may help in the construction of health-care policies to address the changing needs of and financial burdens on the health-care system.

Adolescent↗

PubMed1996

A clinically useful diabetes electronic medical record: lessons from the past; pointers toward the future.

We have analysed the deficiencies of paper medical records in facilitating the care of patients with diabetes and have developed an electronic medical record that corrects some of them. The diabetes electronic medical record (DEMR) is designed to facilitate the work of a busy diabetes clinic. Design principles include heavy reliance on graphic displays of laboratory and clinical data, consistent color coding and aggregation of data needed to facilitate the different types of clinical encounter (initial consultation, continuing care visit, insulin adjustment visit, dietitian encounter, nurse educator encounter, obstetric patient, transplant patient, visits for problems unrelated to diabetes). Data input is by autoflow from the institutional laboratories, by desk attendants or on-line by all users. Careful attention has been paid to making data entry a point and click process wherever possible. Opportunity for free text comment is provided on every screen. On completion of the encounter a narrative text summary of the visit is generated by the computer and is annotated by the care giver. Currently there are about 7800 patients in the system. Remaining challenges include the adaptation of the system to accommodate the occasional user, development of portable laptop derivatives that remain compatible with the parent system and improvements in the screen structure and graphic display formats.

Diabetes Mellitus↗

PubMed2003

A Medicaid population's use of physicians' offices for dental problems.

OBJECTIVES: This study evaluated how the elimination of Medicaid reimbursement to dentists for the treatment of adult dental problems affected patients' visits to physicians. METHODS: Data tapes describing physicians' claims for adult Medicaid patients were obtained from the Maryland Medicaid Management Information System. The database contains information on all claims made to Maryland Medicaid, including date, provider, International Classification of Diseases, Ninth Revision, Clinical Modification Manual code, and payments. RESULTS: A total of 5334 individuals made physician's office claims related to dental problems sometime during the 4-year study period. The rate of dental-related claims by physicians decreased by 8% after the policy change. CONCLUSIONS: Visits to physicians' offices decreased even though an increase might have been expected because of the elimination of access to dentists in private practice. Patients might have assumed that if visits to dentists would no longer be paid for, neither would visits to physicians' offices.

Adult↗

PubMed2004

Economic impact of respiratory syncytial virus-related illness in the US: an analysis of national databases.

OBJECTIVE: To determine the impact of respiratory syncytial virus (RSV) infection on healthcare resource use and costs in the US from the third-party payer perspective. DESIGN: The study retrospectively analysed cross-sectional medical encounter data from three federally funded databases that comprise nationally representative samples of hospital inpatient stays, physician office visits and visits to hospital outpatient departments and emergency rooms. METHODS: Identification of RSV infection-related medical encounters was based on the occurrence of RSV-specific International Classification of Diseases (9th Edition)-Clinical Modification diagnosis codes (079.6, 466.11, 480.1) as principal discharge diagnoses or the assumption that 10-15% of all otitis media visits were due to RSV infection. Outpatient drug costs were estimated based on average wholesale price, and physician fees and test/procedure costs were estimated based on prevailing national fees. Inpatient costs were estimated from total billed charges using a cost-to-charge ratio of 0.53. RESULTS: In 2000, nearly 98% of RSV infection-related hospitalisations occurred in children <5 years old. There were approximately 86,000 hospitalisations, 1.7 million office visits, 402 000 emergency room visits and 236,000 hospital outpatient visits for children <5 years old that were attributable to RSV infection. Total annual direct medical costs for all RSV infection-related hospitalisations ($US394 million) and other medical encounters ($US258 million) for children <5 years old were estimated at $US652 million in 2000. Otitis media was a major cost driver for physician visits. RSV infection-related hospitalisations increased from 1993 to 2000, but average costs per hospitalisation were relatively stable. CONCLUSION: Treatment of RSV infection-related illness represents a significant healthcare burden in the US. The economic impact of ambulatory care for RSV infection-related illness could be as important as that for RSV infection-related hospitalisation.

Ambulatory Care↗

PubMed2000

Studying clinician-computer interaction in Web-based systems.

A growing of health-care organizations are in the process of modifying their clinical information systems (CIS) to support browser-based access. Consequently, care-providers are expected to modify their workflow to take advantage of the new technology. Intuitive interfaces, fast response and new functionality are few of the features used to promote endorsement of the change. In parallel, administrators are required to constantly assess user compliance and intervene where necessary to prevent rejection. Such monitoring translates to frequent surveys, analysis of logs and prudent utilization of user-groups. These methods tend to further burden users, suffer from "post-hoc" temporality and are difficult to maintain. In this paper we suggest an alternative approach to such data acquisition. "CareQuest" is an interactive Web-based service that can be woven into clinical applications without coding. It acquires information from the clinician at the relevant point in her workflow. It allows extensive interaction customization, data-driven response, real-time Web-based data-analysis, and full Web-based administration.

Evaluation Studies as Topic↗

PubMed2001

The ethics of post-marketing surveillance of therapeutic agents.

Trials of new therapies have strict codes of conduct which expect the highest of ethical practice. Local ethics committees review protocols, patient information, consent. National research councils delineate guidelines for minimum standards regarding subjects in such trials. Once medications enter the market place, there is less definition of minimal codes of conduct. Clinical trials are designed to meet regulatory demands to access commercial markets. Prior to marketing, there is a usual drug trial exposure of less than 5,000 individuals which diminishes identification of rare adverse events. Australian case law has found negligence for not warning of a 1:14,000 risk of sympathetic ophthalmia and more recently, in Chappel v Hart, even a speculative risk was grounds for negligence. Recent reports of serious adverse events for conditions such as epilepsy or depression resulted in companies appearing to expend considerable effort to suppress concern rather than to seriously investigate these complications in the post marketing period. This paper will explore such cases and discuss approaches to improve post marketing surveillance and patient protection.

Adverse Drug Reaction Reporting Systems↗

PubMed2002

The medical care cost of childhood and adolescent cancer in Manitoba, 1990-1995.

The main purpose of this study is to estimate the medical care costs of childhood and adolescent cancer in Manitoba, and to determine the elements that influence these costs. Retrospective chart reviews were done to obtain all the information. A total of 118 childhood (age 0-14 years) and 41 adolescent (age 15-19 years) cancer patients were included. For childhood cancer, in-patient hospitalizations accounted for 59% of the total cost, followed by bone marrow transplant (BMT) (9%), medications (8%), laboratory investigations (7%) and physician fees (7%). For adolescent cancer, in-patient hospitalization accounted for 37% of the total cost, followed by bone marrow transplant (BMT) (25%), physicians' fees (11%), medications (9%) and laboratory investigations (7%). Overall, the average cost for the first, second and third year following diagnosis was $50,902 (median 35,708), $13,939 (4,127) and $6,769 (2,565) respectively for childhood cancer patients, and $57,354 (24,192), $16,888 (3,267) and $3,436 (3,267) respectively for adolescent cancer patients. Further work involving long-term data linkage of medical charts with hospital and clinic financial billing codes is needed to provide more accurate estimates of the costs of childhood and adolescent cancer care.

Adolescent↗

PubMed1992

[Arteriovenous fistula of the blood vessels of the neck--a rare differential diagnosis of venous hum in childhood].

In a case report it is shown that in rare circumstances there might be an extracardial organic cause for heart murmurs sounding accidentally. In a child with the finding of a venous hum an arterio-venous fistula between the right common carotid artery and the right internal jugular vein could be demonstrated by colour-coded echocardiography. The clinical relevance of this finding is discussed.

Arteriovenous Malformations↗

PubMed2004

Respiratory insufficiency as a presenting symptom of LGMD2D in adulthood.

Several forms of recessive limb girdle muscular dystrophy (LGMD2C-F) are due to mutations in genes coding for sarcoglycans. Clinically, most sarcoglycanopathies present in childhood with skeletal muscle wasting and early loss of ambulation; respiratory insufficiency is rare. However, some cases of LGMD2D with a late onset and a milder course have been reported. In this study, two adult brothers, compound heterozygous for two missense mutations of the SGCA gene (Arg77Cys, Val247Met), presented with respiratory insufficiency while they were still ambulatory.

Age of Onset↗

PubMed2004

Evaluation of SNOMED coverage of Veterans Health Administration terms.

Veterans Health Administration (VHA) is now evaluating use of SNOMED-CT. This paper reports the first phase of this evaluation, which examines the coverage of SNOMED-CT for problem list entries. Clinician expressions in VA problem lists are quite diverse compared to the content of the current VA terminology Lexicon. We selected a random set of 5054 narratives that were previously "unresolved" against the Lexicon. These narratives were mapped to SNOMED-CT using two automated tools. Experts reviewed a subset of the tools' matched, partly matched, and un-matched narratives. The automated tools produced exact or partial matches for over 90% of the 5054 unresolved narratives. SNOMED-CT has promise as a coding system for clinical problems. In subsequent studies, VA will examine the coverage of SNOMED for other clinical domains, such as drugs, allergies, and physician orders.

Forms and Records Control↗

PubMed2004

Pericarditis following permanent pacemaker insertion.

BACKGROUND: The appearance of pericarditis following insertion of a permanent pacemaker is not widely acknowledged in the literature. OBJECTIVES: To describe our experience with pericarditis following 395 permanent pacemaker implantations over 2 years. METHODS: We retrospectively reviewed the medical records of 395 consecutive patients in whom new pacing systems or pacemaker leads had been implanted over a 2 year period. We searched the records for pericarditis that developed within 1 month after pacemaker implantation according to the ICD-9 code. The incidence, clinical picture, response to treatment, and relationship to lead design and location were studied. RESULTS: Eight cases (2%) of pericarditis following implantation were detected. Clinical manifestations in all patients were similar to those of post-pericardiotomy syndrome and included chest pain (n = 7), friction rub (n = 1), fever (n = 2), fatigue (n = 2), pleural effusion (n = 2), new atrial fibrillation (n = 2), elevated erythrocyte sedimentation rate (n = 4), and echcardiographic evidence of pericardial effusion (n = 8). All affected patients had undergone active fixation (screw-in) lead implantation in the atrial position. The incidence of pericarditis with screw-in atrial leads was 3% compared to 0% in other cases (P < 0.05). CONCLUSIONS: Pericarditis is not uncommon following pacemaker implantation with active fixation atrial leads. Special attention should be paid to identifying pericardial complications following pacemaker implantation, especially when anticoagulant therapy is resumed or initiated. The use of passive fixation leads is likely to reduce the incidence of pericarditis but this issue should be further investigated.

Adrenal Cortex Hormones↗

PubMedDate not supplied

Granulomatous mastitis: a review of 14 cases.

BACKGROUND: Tuberculosis of breast is a rare entity and may be confused with carcinoma of the breast. We present a case series of 14 patients with granulomatous mastitis, seen over a seven-year period from a cancer centre in Lahore, Pakistan. METHODS: The cases were retrieved using electronically coded records and clinical, radiological and pathological data reviewed. Cases with a histologic diagnosis of granulomatous mastitis were included. RESULTS: Granulomatous mastitis was seen at a frequency of 0.37% of the 3768 patients seen with breast diseases (3722 women: 46 men) during this time period. The average age at presentation was 40.7 years [range 14- 65 years]. The most common presentation was a lump in the upper outer quadrant of the breast. Mammography showed a range of appearances. Diagnosis was obtained via fine needle aspiration (10 cases), core biopsy (2 cases) and excision (2 cases). Acid-fast bacilli were seen in five out of the 14 patients. Ten out of 14 patients completed treatment at our centre with satisfactory response. CONCLUSIONS: Granulomatous mastits is an uncommon disease and typically presents with a lump in the breast. The diagnosis can be established by fine needle cytology in the majority of cases. Acid-fast bacilli are seen a minority of the cases.

Adolescent↗