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Issue 121 - 8 Dec 2009

Merry Christmas and Happy Holidays
from the NZNO Library Team


1. Balancing Innovation, Access, and Profits — Market Exclusivity for Biologics
New England Journal of Medicine, Volume 361 — November 12, 2009  
Twenty-five years ago, Congress enacted the Waxman–Hatch Act to facilitate the approval by the Food and Drug Administration (FDA) of low-cost generic drugs that are bioequivalent to approved brand-name drugs. This law has been largely successful, in that generic drugs now account for more than 70% of prescriptions dispensed in the United States (and for 20% of dollars spent on medications). In most cases, a generic version becomes available immediately after the patent protection for a brand-name drug ends.

2. Global Health: Defeating Rotavirus? The Global Recommendation for Rotavirus Vaccination
New England Journal of Medicine, Volume 361 — November 12, 2009
This past April, the World Health Organization (WHO) Strategic Advisory Group of Experts (SAGE) on Immunization announced a global recommendation that rotavirus vaccines be included in national immunization programs. The basis for the decision is clear: more than 2 million children younger than 5 years of age are hospitalized each year because of rotavirus gastroenteritis, and more than half a million of them die. The introduction of rotavirus vaccines into national immunization programs in the United States, Europe, Latin America, and Australia has already caused a significant decline in hospitalizations and emergency department visits for rotavirus disease.
3. The Service [A memorial service for a patient]
New England Journal of Medicine, Volume 361 — November 12, 2009  
This morning, I came upon an intern engrossed at the computer. "I am looking up the diseases Mr. Crosby died of," she explained. The octogenarian had been on our unit for 4 weeks with multiorgan failure. His usually jovial nature had changed toward the end, and we all accepted that he had given up. I thought we had a good rapport with his family, though, so I was surprised by the intern's wariness. "Is there a problem?" "Not yet," she said. "But you know what families can be like."

4. Communal Responsibility for Health Care — The Example of Benefit Assessment in Germany
New England Journal of Medicine, Volume 361 — November 12, 2009  
Many German observers are bewildered over the U.S. health care reform debate. Most Europeans see affordable health insurance for everyone as a fundamental element of a stable and prosperous society — an element founded on the principle of communal responsibility. Like the United States, Germany is a wealthy, democratic society with strong nongovernmental community institutions.1 In Germany, 90% of the population pays affordable contributions into the community-based system of statutory health insurance funds, which is supplemented by employer contributions and some taxes. The remaining 10% of citizens, most of whom have above-average incomes, pay into private insurance schemes.

5. Ensuring Progress in Primary Care — What Can Health Care Reform Realistically Accomplish?
New England Journal of Medicine, Volume 361 — November 12, 2009 
In the current political environment, forging consensus on health care reform has proven challenging. Yet the value of a strengthened primary care infrastructure is one apparent zone of agreement among policymakers. Leading professional societies have converged upon principles for restructuring primary health care in their support of the patient-centered medical home (see Table 1).1 In addition to this reorganization of primary care delivery, experts have recommended three other areas of improvement: payment reform, augmentation of the primary care workforce, and better tracking of care coordination between primary care physicians and specialists.
6. Critical Care Services and 2009 H1N1 Influenza in Australia and New Zealand: The ANZIC Influenza Investigators
New England Journal of Medicine, Volume 361 — November 12, 2009
Planning for the treatment of infection with the 2009 pandemic influenza A (H1N1) virus through health care systems in developed countries during winter in the Northern Hemisphere is hampered by a lack of information from similar health care systems.
Methods: We conducted an inception-cohort study in all Australian and New Zealand intensive care units (ICUs) during the winter of 2009 in the Southern Hemisphere. We calculated, per million inhabitants, the numbers of ICU admissions, bed-days, and days of mechanical ventilation due to infection with the 2009 H1N1 virus. We collected data on demographic and clinical characteristics of the patients and on treatments and outcomes.
Results: From June 1 through August 31, 2009, a total of 722 patients with confirmed infection with the 2009 H1N1 virus (28.7 cases per million inhabitants; 95% confidence interval [CI], 26.5 to 30.8) were admitted to an ICU in Australia or New Zealand. Of the 722 patients, 669 (92.7%) were under 65 years of age and 66 (9.1%) were pregnant women; of the 601 adults for whom data were available, 172 (28.6%) had a body-mass index (the weight in kilograms divided by the square of the height in meters) greater than 35. Patients infected with the 2009 H1N1 virus were in the ICU for a total of 8815 bed-days (350 per million inhabitants). The median duration of treatment in the ICU was 7.0 days (interquartile range, 2.7 to 13.4); 456 of 706 patients (64.6%) with available data underwent mechanical ventilation for a median of 8 days (interquartile range, 4 to 16). The maximum daily occupancy of the ICU was 7.4 beds (95% CI, 6.3 to 8.5) per million inhabitants. As of September 7, 2009, a total of 103 of the 722 patients(14.3% ;95% CI, 11.7 to 16.9) had died, and 114 (15.8%) remained in the hospital.
Conclusions: The 2009 H1N1 virus had a substantial effect on ICUs during the winter in Australia and New Zealand. Our data can assist planning for the treatment of patients during the winter in the Northern Hemisphere.

7. Hospitalized Patients with 2009 H1N1 Influenza in the United States, April–June 2009
New England Journal of Medicine, Volume 361 — November 12, 2009  

Background: During the spring of 2009, a pandemic influenza A H1N1) virus emerged and spread globally. We describe the clinical characteristics of patients who were hospitalized with 2009 H1N1 influenza in the United States from April 2009 to mid-June 2009.
Methods: Using medical charts, we collected data on 272 patients who were hospitalized for at least 24 hours for influenza-like illness and who tested positive for the 2009 H1N1 virus with the use of a real-time reverse-transcriptase–polymerase-chain-reaction assay.
Results: Of the 272 patients we studied, 25% were admitted to an intensive care unit and 7% died. Forty-five percent of the patients were children under the age of 18 years, and 5% were 65 years of age or older. Seventy-three percent of the patients had at least one underlying medical condition; these conditions included asthma; diabetes; heart, lung, and neurologic diseases; and pregnancy. Of the 249 patients who underwent chest radiography on admission, 100 (40%) had findings consistent with pneumonia. Of the 268 patients for whom data were available regarding the use of antiviral drugs, such therapy was initiated in 200 patients (75%) at a median of 3 days after the onset of illness. Data suggest that the use of antiviral drugs was beneficial in hospitalized patients, especially when such therapy was initiated early. Conclusions: During the evaluation period, 2009 H1N1 influenza caused severe illness requiring hospitalization, including pneumonia and death. Nearly three quarters of the patients had one or more underlying medical conditions. Few severe illnesses were reported among persons 65 years of age or older. Patients seemed to benefit from antiviral therapy.

8. Cross-Reactive Antibody Responses to the 2009 Pandemic H1N1 Influenza Virus
New England Journal of Medicine, Volume 361 — November 12, 2009

Background: A new pandemic influenza A (H1N1) virus has emerged, causing illness globally, primarily in younger age groups. To assess the level of preexisting immunity in humans and to evaluate seasonal vaccine strategies, we measured the antibody response to the pandemic virus resulting from previous influenza infection or vaccination in different age groups.
Methods: Using a microneutralization assay, we measured cross-reactive antibodies to pandemic H1N1 virus (2009 H1N1) in stored serum samples from persons who either donated blood or were vaccinated with recent seasonal or 1976 swine influenza vaccines.
Results: A total of 4 of 107 persons (4%) who were born after 1980 had preexisting cross-reactive antibody titers of 40 or more against 2009 H1N1, whereas 39 of 115 persons (34%) born before 1950 had titers of 80 or more. Vaccination with seasonal trivalent inactivated influenza vaccines resulted in an increase in the level of cross-reactive antibody to 2009 H1N1 by a factor of four or more in none of 55 children between the ages of 6 months and 9 years, in 12 to 22% of 231 adults between the ages of 18 and 64 years, and in 5% or less of 113 adults 60 years of age or older. Seasonal vaccines that were formulated with adjuvant did not further enhance cross-reactive antibody responses. Vaccination with the A/New Jersey/1976 swine influenza vaccine substantially boosted cross-reactive antibodies to 2009 H1N1 in adults.
Conclusions: Vaccination with recent seasonal nonadjuvanted or adjuvanted influenza vaccines induced little or no cross-reactive antibody response to 2009 H1N1 in any age group. Persons under the age of 30 years had little evidence of cross-reactive antibodies to the pandemic virus. However, a proportion of older adults had preexisting
cross-reactive antibodies.

9. Revascularization versus Medical Therapy for Renal-Artery Stenosis: The ASTRAL Investigators
New England Journal of Medicine, Volume 361 — November 12, 2009
Percutaneous revascularization of the renal arteries improves patency in atherosclerotic renovascular disease, yet evidence of a clinical benefit is limited.
Methods: In a randomized, unblinded trial, we assigned 806 patients with atherosclerotic renovascular disease either to undergo revascularization in addition to receiving medical therapy or to receive medical therapy alone. The primary outcome was renal function, as measured by the reciprocal of the serum creatinine level (a measure that has a linear relationship with creatinine clearance). Secondary outcomes were blood pressure, the time to renal and major cardiovascular events, and mortality. The median follow-up was 34 months.
Results: During a 5-year period, the rate of progression of renal impairment (as shown by the slope of the reciprocal of the serum creatinine level) was –0.07x10–3 liters per micromole per year in the revascularization group, as compared with –0.13x10–3 liters per micromole per year in the medical-therapy group, a difference favoring revascularization of 0.06x10–3 liters per micromole per year (95% confidence interval [CI], –0.002 to 0.13; P=0.06). Over the same time, the mean serum creatinine level was 1.6 µmol per liter (95% CI, –8.4 to 5.2 [0.02 mg per deciliter; 95% CI, –0.10 to 0.06]) lower in the revascularization group than in the medical-therapy group. There was no significant between-group difference in systolic blood pressure; the decrease in diastolic blood pressure was smaller in the revascularization group than in the medical-therapy group. The two study groups had similar rates of renal events (hazard ratio in the revascularization group, 0.97; 95% CI, 0.67 to 1.40; P=0.88), major cardiovascular events (hazard ratio, 0.94; 95% CI, 0.75 to 1.19; P=0.61), and death (hazard ratio, 0.90; 95% CI, 0.69 to 1.18; P=0.46). Serious complications associated with revascularization occurred in 23 patients, including 2 deaths and 3 amputations of toes or limbs.
Conclusions: We found substantial risks but no evidence of a worthwhile clinical benefit from revascularization in patients with atherosclerotic renovascular disease. (Current Controlled Trials number, ISRCTN59586944 [].)

10. Outcome Reporting in Industry-Sponsored Trials of Gabapentin for Off-Label Use
New England Journal of Medicine, Volume 361 — November 12, 2009 
There is good evidence of selective outcome reporting in published reports of randomized trials.
Methods: We examined reporting practices for trials of gabapentin funded by Pfizer and Warner-Lambert's subsidiary Parke-Davis (hereafter referred to as Pfizer and Parke-Davis) for off-label indications (prophylaxis against migraine and treatment of bipolar disorders, neuropathic pain, and nociceptive pain), comparing internal company documents with published reports.
Results: We identified 20 clinical trials for which internal documents were available from Pfizer and Parke-Davis; of these trials, 12 were reported in publications. For 8 of the 12 reported trials, the primary outcome defined in the published report differed from that described in the protocol. Sources of disagreement included the introduction of a new primary outcome (in the case of 6 trials), failure to distinguish between primary and secondary outcomes (2 trials), relegation of primary outcomes to secondary outcomes (2 trials), and failure to report one or more protocol-defined primary outcomes (5 trials). Trials that presented findings that were not significant (P0.05) for the protocol-defined primary outcome in the internal documents either were not reported in full or were reported with a changed primary outcome. The primary outcome was changed in the case of 5 of 8 published trials for which statistically significant differences favoring gabapentin were reported. Of the 21 primary outcomes described in the protocols of the published trials, 6 were not reported at all and 4 were reported as secondary outcomes. Of 28 primary outcomes described in the published reports, 12 were newly introduced.
Conclusions: We identified selective outcome reporting for trials of off-label use of gabapentin. This practice threatens the validity of evidence for the effectiveness of off-label interventions.

11. Renal-Artery Stenosis
New England Journal of Medicine, Volume 361 — November 12, 2009  
This Journal feature begins with a case vignette highlighting a common clinical problem. Evidence supporting various strategies is then presented, followed by a review of formal guidelines, when they exist. The article ends with the authors' clinical recommendations. A 73-year-old former smoker with a history of hypertension and dyslipidemia presents to the emergency department with shortness of breath. His blood pressure is 160/75 mm Hg, heart rate 60 beats per minute, and respiratory rate 24 breaths per minute. Chest auscultation reveals diffuse rales, and there is 1+ pitting edema.

12. Extensive Bowel Infarction
New England Journal of Medicine, Volume 361 — November 12, 2009  
A 45-year-old man presented to the emergency room with abdominal pain that had been increasing over the previous week and hematemesis and melena that had begun in the preceding 12 hours. He had drunk 36 alcoholic drinks per day for 20 years and had been on a binge for the 2 days preceding his admission. On presentation, he was in clinical shock, with an unrecordable blood pressure and a heart rate of 117 beats per minute. He had acidosis(blood pH, 7.27)coagulopathy (international normalized ratio, 1.3), and acute renal failure (ratio of blood urea nitrogen [millimoles per liter]

13. Geographic Tongue
New England Journal of Medicine, Volume 361 — November 12, 2009  
A 61-year-old man was referred for treatment of painless white lesions on his tongue that had appeared 1 month earlier. He had been treated with topical and systemic antifungal drugs for presumed oral candidiasis, but the lesions remained unchanged. The patient reported that a similar episode 1 year earlier had resolved spontaneously. Lingual examination revealed multiple erythematous patches with an annular, well-demarcated white border. A diagnosis of geographic tongue was made. Geographic tongue (benign migratory glossitis) is a benign inflammatory condition that affects approximately 2% of the world's population.

14. Case 35-2009 — A 60-Year-Old Male Renal-Transplant Recipient with Renal Insufficiency, Diabetic Ketoacidosis,
and Mental-Status Changes
New England Journal of Medicine, Volume 361 — November 12, 2009
Presentation of Case:

Dr. Peter P. Moschovis (Medicine and Pediatrics): A 60-year-old man with diabetes mellitus and a history of renal transplantation was admitted to this hospital because of mental-status changes, diarrhea, renal insufficiency, diabetic ketoacidosis, and hypotension. The patient was in his usual state of health, with chronic respiratory problems, until approximately 2 months before admission, when increasing fatigue, somnolence, and intermittent mild confusion developed, associated with diarrhea and decreasing glycemic control. Three weeks before admission, he was admitted to another hospital because of increasing orthopnea and paroxysmal nocturnal dyspnea. On examination, there were crackles in the bilateral midlung fields.

15. Preparing for 2009 H1N1 Influenza
New England Journal of Medicine, Volume 361 — November 12, 2009
In 1743, when disease was presumed to be astral in origin, European newspapers reported on a contagious influence (influenza in Italian) that was being visited on the citizens of Rome. Two hundred years later, Wilson Smith and colleagues would isolate an influenza A virus, one of the members of the orthomyxovirus family.1 The key reservoirs of all influenza A viruses are migrating waterfowl, and intermittently, other hosts, such as pigs and people, are infected.

16. Isolated Tumor Cells in Breast Cancer
New England Journal of Medicine, Volume 361 — November 12, 2009
To the Editor: In their article, de Boer et al. (Aug. 13 issue)1 suggest that adjuvant systemic therapy may improve disease-free survival in breast cancer. However, the apparent treatment effect may also be due to imbalances in prognostic and predictive factors (such as hormone-receptor status) that drive clinical decision making. The failure to distinguish between systemic chemotherapy and hormonal therapy and the use of composite outcomes that are mostly unrelated to nodal involvement further cloud the primary questions.

17. Age-Related Memory Decline and the APOE 4 Effect
New England Journal of Medicine, Volume 361 — November 12, 2009
To the Editor: Cognitive decline is a complex multifactorial process, and so it is important to exclude as many potentially confounding variables as possible when assessing the influence of a single factor. In their longitudinal study, Caselli and colleagues (July 16 issue)1 apparently did not take into account some such variables, including alcohol consumption, mentally stimulating activities, and smoking.2,3,4 In addition, physical inactivity is reported to be a risk factor for cognitive decline, especially among persons carrying the apolipoprotein E (APOE) 4 allele.

18. AGC1 Deficiency and Cerebral Hypomyelination
New England Journal of Medicine, Volume 361 — November 12, 2009
Abstract: To the Editor: Wibom et al. (July 30 issue)1 suggest that impaired function of mitochondrial aspartate–glutamate carrier isoform 1 (AGC1) leads to hypomyelination. However, the results of magnetic resonance imaging (MRI) suggest differently. In true hypomyelination, the supratentorial white matter is hyperintense on T2-weighted MRI, and in young children cerebral atrophy is mild or absent (Figure 1).2 Early-onset, severe atrophy points to primary
cortical degeneration.1 The clinical features of the patient, including epilepsy and severe retardation, also suggest a cortical disease rather than a leukoencephalopathy.

19. Neurologic Prognosis after Cardiac Arrest
New England Journal of Medicine, Volume 361 — November 12, 2009
To the Editor:
We are concerned that Young (Aug. 6 issue)1 did not emphasize the considerable help provided by the clinical history in predicting the prognosis for a patient after cardiac arrest. Elements of the clinical history — such as the location of the arrest (home or outdoors), the presence or absence of witnesses, and the chronology(delays in delivery of cardiopulmonary resuscitation and the first therapeutic shock) — are generally easy to collect and are strongly associated with outcomes.2,3 Therefore, such information may assist clinicians in making the difficult decision to withdraw life support.

20. Older Age and a Reduced Likelihood of 2009 H1N1 Virus Infection
New England Journal of Medicine, Volume 361 — November 12, 2009
To the Editor: Early epidemiologic reports regarding the 2009 pandemic influenza A (H1N1) virus suggest that cases of infection and deaths are concentrated in adults between the ages of 20 and 40 years.1 This finding could reflect age-related differences in susceptibility or differential testing and diagnosis in this age group. Increased susceptibility to infection in young persons is characteristic of influenza pandemics and has important implications for disease-control policy.2 We examined whether the reported excess of cases in younger persons derives from testing practices or reflects a differential risk of infection in Ontario, Canada.

21. Pathological Changes Associated with the 2009 H1N1 Virus
New England Journal of Medicine, Volume 361 — November 12, 2009
To the Editor:
Between April 23, 2009, and May 15, 2009, we performed 15 autopsies on deceased patients in whom probable influenza had been diagnosed either clinically or macroscopically. Small samples of lung tissue were obtained and taken for analysis to the Institute of Epidemiological Diagnosis and Reference in Mexico City. Five infections with the 2009 pandemic influenza A (H1N1) virus were confirmed with the use of a real-time reverse-transcriptase–polymerase-chain-reaction assay, after it was determined that these patients were seronegative for influenza B virus, respiratory syncytial virus, parainfluenza virus (types 1, 2, and 3), and adenovirus.

Journals – Table of Contents

22. From Australian Nursing Journal, 01/12/2009, Vol. 17 Issue 6
22A. Editorial [Nurses and midwives are poised to play a much more active role in reshaping the health agenda in Australia with ongoing reform of the way health care is delivered around the country]
22B. Health Legislation Amendment (Midwives and Nurse Practitioners) Bill 2009
22C. Don't let us down: a message to Health Minister Nicola Roxon from nurses and midwives and the communities they care for.
22D. Surprised and concerned [3 letters to the editor about the Health Legislation Amendment (Midwives and Nurse Practitioners) Bill 2009]
22E. ANMC launches national standards [The Australian Nursing and Midwifery Council (ANMC) launched new national standards for the accreditation of nursing and midwifery courses]; WHO expert visits Australia
22F. ANF message loud and clear [The ANF’s because we care campaign is being heard by the Australian government and the message is “loud and clear”, Federal Health Minister Nicola Roxon said last month]
22G. 2010: a decisive year for aged care
22H. From evidence to innovation [Nurse practitioners are key innovators and should not have to defend their roles, says a leading nurse academic Alison Kitson]
22I. Indigenous healing foundation [A new Aboriginal and Torres Strait Islander Healing Foundation has been launched aimed to help Indigenous people deal with issues of trauma and healing]
22J. New drugs program; Cost shifting politics; Gender pay gap widens
22K. Landmark pay equity case for low paid [Tens of thousands of low paid social and community services workers may receive pay rises of more than $100 a week under the Commonwealth’s first federal test case on pay equity under the new Fair Work system]
22L. Detention centres appalling [Asylum seekers are being housed in squalid, cramped and filthy conditions in many Indonesian immigration detention facilities]
22M. Aged pay gap soars; 20. No re-entry program [The ANF Tasmanian Branch has called on the state government to procure a re-entry program for nurses wanting to return to work for more than 12 months]

23. From New Zealand College of Midwives Journal, 01/10/2009 Issue 41, p6
Twenty years on: where to from here?
23B. Warkworth Birthing Centre: exemplifying the future
23C. Report on mapping the rural midwifery workforce in New Zealand for 2008 [By Hendy, Chris]
23D. Midwives care during the Third Stage of Labour: An analysis of the New Zealand College of Midwives Midwifery Database 2004-2008
23E. The cost of healthy eating: for pregnant and breastfeeding women in Otago
23F. To suture or not to suture second degree perineal lacerations: What informs this decision?
23G. The Midwives' Guide: to Key Medical Conditions in Pregnancy and Birth (2008)
23H. Fetal monitoring in practice

24. From Journal of the Australasian Rehabilitation Nurses' Association (JARNA), 01/09/2009, Vol. 12 Issue 3
24A. President's Report [The article offers an overview of the status of the Australasian Rehabilitation Nurses'
Association (ARNA) as of September 2009. The elected state chapter presidents of the ARNA include Tracey Weir of Illwara, Wendy Harper of Queensland and Rani Govender of Victoria/Tasmania. The association is said to be in a good financial condition considering its solid financial management. Other topics tackled include leadership at ARNA, the professional development it offers and its membership base]
24B. Providing information to stroke survivors: Lessons from a failed randomised controlled trial.
24C. Interventions for Rehabilitation Post-Stroke and the Contribution of the Nursing Staff
24D. Australasian Rehabilitation Nurses' Association 19th National Conference
24E. AROC - Who are we and what do we do?

25. From Australian Occupational Therapy Journal, 01/09/2008, Vol 55 Issue 3
25A. Looking forward [People who the author would like to thank for their assistance in the editor's first editing job in the publication "Australian Occupational Therapy Journal" are mentioned]
25B. A time for sharing [The article offers information on the OT Australia conference to be held in Australia in September 2008]
25C. Shaping knowledge regarding occupation: Examining the cultural underpinnings of the evolving concept of occupational identity
25D. South Australian school teachers’ perceptions of occupational therapy reports
25E. Validation of the Visual Recognition Slide Test with stroke: A component of the New South Wales occupational therapy off-road driver rehabilitation program
25F. Language, identity and representation: Occupation and occupational therapy in acute settings
25G. Measuring information processing in a client with extreme agitation following traumatic brain injury using the Perceive, Recall, Plan and Perform System of Task Analysis
25H. Development of the Activity Card Sort — Australia

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